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UNITED STATES DISTRICT COURTNORTHERN DISTRICT OF TEXAS

PUBLIC HEALTH AND MEDICAL PROFESSIONALS FOR TRANSPARENCY,

Plaintiff,-against-

FOOD AND DRUG ADMINISTRATION,

Defendant.

Civil Action No. 4:21-cv-01058-P

APPENDIX IN SUPPORT OF BRIEF FOR TIMELY PRODUCTION

NOW COMES, Plaintiff Public Health and Medical Professionals for Transparency and

files this Appendix in Support of its Brief for Timely Production.

Exhibit Description Page No.

A Declaration of Peter McCullough, MD, MPH, President of Public Health and Medical Professionals for Transparency (PHMPT)

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B Declaration of Harvey Risch, MD, PhD App000004 –App000102

C Declaration of Tom Jefferson, MD MRCGP FFPHM App000103 –App000150

D Declaration of Peter McCullough, MD, MPH App000151 –App000336

E Declaration of Aaron Siri, Esq. App000337 –App000579

Unpublished Cases App000580 –App000631

Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 1 of 633 PageID 727Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 1 of 633 PageID 727

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Dated: December 7, 2021

SIRI & GLIMSTAD LLP

Aaron Siri, NY Bar No. 4321790Elizabeth A. Brehm, NY Bar No. 4660353Gabrielle G. Palmer, CO Bar No. 48948200 Park AvenueNew York, New York 10166Tel: (212) 532-1091Fax: (646) [email protected]@[email protected]

HOWIE LAW, PCJohn HowieTexas Bar Number: 24027239 2608 Hibernia StreetDallas, Texas 75204Tel: (214) [email protected]

Attorneys for Plaintiff

Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 2 of 633 PageID 728Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 2 of 633 PageID 728

Exhibit

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Case 4:21-cv-01058-P Document 27 Filed 12/07/21 of 633 PageID 729Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 3 of 633 PageID 729

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Exhibit

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Curriculum Vitae of Harvey A. Risch, M.D., Ph.D.(Exhibit A to Risch Declaration)

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Curriculum Vitae for: HARVEY A. RISCH, M.D., PH.D.

Professor of Epidemiology Yale School of Public Health, Yale School of Medicine

Business Address: Yale School of Public Health 60 College Street, LEPH 413 P.O. Box 208034, New Haven, CT 06520-8034 Phone: (203) 785-2848; Fax: (203) 785-4497 E-mail: [email protected]

Education:Date School Degree, Major

9/80-12/82 University of Washington Postdoctoral Fellow, Epidemiology 9/76-8/80 University of Chicago Ph.D., Biomathematics 9/72-6/76 UC San Diego School of Medicine M.D., Medicine9/67-6/72 California Institute of Technology B.S. (Honors), Biology; Mathematics

Professional Appointments:

7/01- Professor of Epidemiology, Department of Chronic Disease Epidemiology, Yale School of Public Health, Yale School of Medicine, New Haven, CT.

1/12- Director, Molecular Cancer Epidemiology Laboratory and Shared Resource, Yale Comprehensive Cancer Center and Yale School of Public Health

9/06-8/07 Lady Davis Visiting Professor, Department of Community Medicine and Epidemiology, Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel

1/91-6/01 Associate Professor of Epidemiology, Department of Epidemiology and Public Health, Yale University School of Medicine.

1/83-12/90 Epidemiologist-Biostatistician, Epidemiology Unit, National Cancer Institute of Canada, Toronto, Ontario.

7/90-12/90 Associate Professor, Department of Preventive Medicine and Biostatistics, University of Toronto, Toronto, Ontario (Concurrent Appointment).

1/83-6/90 Assistant Professor, Department of Preventive Medicine and Biostatistics, University of Toronto, Toronto, Ontario (Concurrent Appointment).

9/80-12/82 Postdoctoral Fellow, Department of Epidemiology, School of Public Health and Community Medicine, University of Washington, Seattle, Washington.

7/79-8/80 Postdoctoral Fellow, Department of Pathology, University of Chicago, Chicago, Illinois.

h-Index: 9 . Publication citations: more than 4 ,000 research citations as of 22, 2021.

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Awards, Memberships, etc.:NSF Undergraduate Research Fellowship, Department of Mathematics, California Institute of

Technology, Pasadena (6/70-9/70) General Medicine Stipended Externship, UC San Diego School of Medicine, La Jolla (6-9/73) Theoretical Biology Predoctoral Traineeship, University of Chicago (9/76-6/79) Pathobiology Postdoctoral Traineeship (GM 7190), University of Chicago (7/79-8/80) Cancer Epidemiology Postdoctoral Traineeship (CA 9168), University of Washington (9/80-12/82)Member, Society for Epidemiologic Research (1982- ) Member, American Society of Preventive Oncology (1984- ) Full Member, Sigma Xi (1986- ) Fellow, American College of Epidemiology (1991- ); Member (1984-91) Member, Yale Cancer Center (1992- ), Sections: Cancer Prevention and Control; Gynecologic

Oncology; Cancer Genetics “Best of the AACR Journals” for “Aspirin Use and Reduced Risk of Pancreatic Cancer,” one of

the most highly cited Cancer Epidemiology, Biomarkers & Prevention (CEBP) articles published in 2016 (April 2018) ( http://aacrjournals.org/h-a-risch-bio )

The Ruth Leff Siegel Award for Excellence in Pancreatic Cancer Research (2018), $50,000 ( http://columbiasurgery.org/pancreas/ruth-leff-siegel-award )

Member, Connecticut Academy of Science and Engineering (2019- ) Highest attention paper ever published in the American Journal of Epidemiology (2020)

(https://oxfordjournals.altmetric.com/details/82900954)

Consortia: BEACON: Barrett's Esophagus and Esophageal Adenocarcinoma Consortium (2005- ) OCAC: Ovarian Cancer Association Consortium (International Consortium of Case-Control

Studies of Ovarian Cancer) (2005- ) PanC4: Pancreatic Cancer Case-Control Consortium (2006- ); Elected Steering Committee

Member (2008-2013, 2014-2017, 2018-2021) Panscan: Pancreas Cancer Genome-wide Association Study Consortium (2008- ) CIMBA: Consortium of Investigators of Modifiers of BRCA1/2 (2017- )

Research Interests:Cancer epidemiology and etiology—Pancreas, Ovary, Lung, Breast, Stomach, Bladder, etc. Cancer genetic epidemiology: polymorphisms, major genes; Hormonal factors and cancer; Occupa-

tional/environmental exposures and cancer; Diet and cancer; Helicobacter pylori and cancerEpidemiologic methods; Causal inference; Cancer registration, control and prevention

Teaching Experience:Advanced Epidemiologic Research Methods (Yale University CDE 619a) (Course developer) Fundamentals of Epidemiology (Yale University CDE/EMD 508) (Course developer) Principles of Epidemiology II (Yale University CDE 516) (Course developer) Research Methods in Epidemiology I (University of Toronto CHL 4102f) (Course co-developer) Research Methods in Epidemiology II (University of Toronto CHL 4105s) (Course developer) Cancer Epidemiology (University of Toronto CHL 4103f; Yale University CDE 532b)

TraineesPhD: Advisor to five students; dissertation committee member for 11 students. MPH or MSc: Advisor to 36 students. Postdoctoral Fellows: Advisor to 16 fellows.

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Visiting Faculty: Host to four visiting professors.

Service Activity:Grant Review Panels:

Health Canada, National Health Research and Development Program: Epidemiology, Occupational Health and Chronic Disease Panel (1987-91)

NIH External Site Reviewer (1995) NIH Study Section Regular Member: Epidemiology and Disease Control (EDC2) (1997) US Army MRMC Ovarian Cancer Research Program Integration Panel Member (1997-2002) American Cancer Society Extramural Grant Reviewer (1998)Chair, Epidemiology Grant Review Panel, National Cancer Institute of Canada (2000-2) Dutch Cancer Society Extramural Research Grant Reviewer (2000, 2001, 2008) Cancer Council Australia Extramural Research Grant Reviewer (2004)Pancreatic Cancer Action Network-AACR Career Development Awards Scientific Review

Committee (2016-8) NIH Study Section Member: Epidemiology and Disease Control (EDC2) (2000) NIH Study Section Member: Epidemiology Special Emphasis Panel (ZRG4, 1998; ZRG1, 2001-3) NIH Study Section Member: Pancreas SPORE Panel (ZCA1 GRB-V, 2002-3) NIH Study Section Member: Small Grants Program for Cancer Epidemiology Panel (ZCA1

SRRB-Q, 2003) NIH Study Section Member: Cancer Genetics Panel (CG) (2004, 2006) NIH Study Section Member: Cancer Epidemiology, Prevention and Control (NCI-E X1) (2005) NIH Study Section Member: Breast and Ovarian Cancer Genetics (ZRG1 ONC-U 03M) (2005) NIH Study Section Member: Gene-Environment Interactions (ZHL1 CSR-D S1 R) (2007) NIH Study Section Member: Epidemiology of Cancer Member Conflicts (ZRG1 HOP-Q, 2009;

ZRG1 PSE-B, 2010) NIH Study Section Member: Barrett's Esophagus Translational Research Network (ZCA1 SRLB-1

(O1) R, 2011) NIH Study Section Member: Core Infrastructure and Methodological Research for Cancer

Epidemiology Cohorts (ZCA1 SRLB-9 (M2) B, 2013; ZCA1 TCRB-9 (J2) R, 2014; ZCA1SRBJ (O2) S, 2015)

NIH Study Section Member: Cancer Management, Epidemiology, and Health Behavior (ZCA1 SRLB-B (J1) S, 2013)

NIH Study Section Member: Population Science (U01) (ZCA1 RTRB-Z M1 R, 2016) Medical Research Council UK External Reviewer (2019)

Journal Editor:Associate Editor, American Journal of Epidemiology (1997-2014) Editor pro tem, American Journal of Epidemiology (2002-2014) Member, Board of Editors, American Journal of Epidemiology (2014-2020) Associate Editor, Journal of the National Cancer Institute (2000- ) Editor, International Journal of Cancer (2008- )

Journal Referee:Alimentary Pharmacology & Therapeutics (2015- ) American Journal of Epidemiology (1986- ) American Journal of Medical Genetics (2004- ) American Journal of Obstetrics and Gynecology (2015- ) American Journal of Preventive Medicine (1988- )

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Annals of Epidemiology (1992- ) Annals of Oncology (2001- ) Annals of Surgical Oncology (2011- ) Biodemography and Social Biology (2018- ) Biometrics (1990- ) Blood Transfusion (2015- ) BMC Cancer (2007- ) BMC Public Health (2007- ) British Journal of Cancer (2003- ) Canadian Journal of Public Health (1987- ) Canadian Medical Association Journal (1983- ) Cancer (1996- ) Cancer Causes and Control (1992- ) Cancer Detection and Prevention (2003-2009) Cancer Epidemiology (2009- ) Cancer Epidemiology, Biomarkers and Prevention (1995- ) Cancer Genetics (2012- ) Cancer Research (1988- ) Carcinogenesis (2008- ) Clinical Cancer Research (2015- ) Clinical Gastroenterology and Hepatology (2007- ) Current Pharmacogenomics (2007- ) DNA and Cell Biology (2019- ) Environmental Pollution (2018- ) Epidemiology (1989- ) European Journal of Cancer (2001- ) European Journal of Epidemiology (1995- ) European Journal of Human Genetics (2008- ) Gastroenterology (2007- ) Gynecologic Oncology (1997- ) International Journal of Cancer (1995- ) International Journal of Epidemiology (1995- ) JAMA (1990- ) Journal for Nurse Practitioners (2018- ) Journal of Clinical Epidemiology (2006- ) Journal of Clinical Gastroenterology (2010- ) Journal of Clinical Medicine (2019- ) Journal of Epidemiology (2016- ) Journal of Infectious Diseases (2002- ) Journal of the National Cancer Institute (1992- ) Menopause (2011- ) Molecular Carcinogenesis (2009- ) Nature Clinical Practice Oncology (2005- ) Nature Scientific Reports (2016- ) New England Journal of Medicine (2017- ) Oncology Research (2001- ) Oncotarget (2017- ) Preventive Medicine (1994- )

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Reproductive Sciences (2008- ) Science (2004- ) Treatments in Endocrinology (2003- ) Tumor Biology (2015- ) World Journal of Gastroenterology (2013- )

Other Review and Service:Society for Epidemiologic Research Student Prize Paper Review Committee (1987, 1994) American Society for Clinical Oncology Cancer Prevention Curriculum (2006) External Advisory Board Member, Multiple Myeloma Prevention Program Project, Washington

University (2014-2015) Mayo Clinic SPORE in Pancreatic Cancer External Advisory Committee (2018-2023) Connecticut Academy of Science and Engineering (CASE) Advisory Committee on Covid-19

for Reopening Connecticut (2020)

Academic and Professional Standing Committees:Yale School of Public Health:

Doctoral (Admissions and Progress; 1991-1999) MPH (Academic Progress; 1991-1995) Computer (1999-2001) Medical Studies (2000-2005) Chair, Genetics and Public Health Interest Group (2003-2006) Chair, C.E.A. Winslow Medal Committee (2007-2010) Chair, Hildreth Memorial Fund Committee (2007-2012) The Honorable Tina Brozman Foundation Small Grant Proposal Review Committee (2010) Chair, MPH Thesis Dean’s Prize Committee (2010- ) Chair, Department of Chronic Disease Epidemiology, Epidemiology Competencies Committee (2015- ) Committee for Academic and Professional Integrity (2018-2021) Education Committee (2019-)

Yale School of Medicine:Program in Investigative Medicine Doctoral Committee (1999-2007) Mentored Clinical Research Scholar Program Advisory Board (2003-2008)

Yale Cancer Center: Rapid Case Ascertainment System Shared Resource (1995- ) American Cancer Society Institutional Research Award Review Committee (1996-2001)

American College of Epidemiology: Education Committee (1996-2002) Policy Committee (1997-2003)

Peer-Reviewed Research Publications:Accepted for Publication or In-Press

Cartmel B, Hughes M, Ercolano EA, Gottlieb L, Li F, Zhou Y, Harrigan M, Ligibel JA, von Gruenigen VE, Gogoi R, Schwartz PE, Risch HA, Lu L, Irwin ML. Randomized trial of exercise on depressive symptomatology and brain derived neurotrophic factor (BDNF) in ovarian cancer survivors: The Women's Activity and Lifestyle Study in Connecticut (WALC).

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Gynecol Oncol 2021:S0090-8258(21)00195-5. doi: 10.1016/j.ygyno.2021.02.036. PMCID: PMC Journal in Process. In Press.

Zhang H, Greenwood DC, Risch HA, Bunce D, Hardie LJ, Cade JE. Meat consumption and risk of incident dementia: cohort study of 493,888 UK Biobank participants. Am J Clin Nutr 2021:nqab028. doi: 10.1093/ajcn/nqab028. PMCID: PMC Journal in Process. In Press.

Mocci E, Kundu P, Wheeler W, Arslan AA, Beane Freeman LE, Bracci PM, Brennan P, Canzian F, Du M, Gallinger S, Giles GG, Goodman PJ, Kooperberg C, Le Marchand L, Neale RE, Shu XO, Visvanathan K, White E, Zheng W, Albanes D, Andreotti G, Babic A, Bamlet WR, Berndt SI, Blackford AL, Bueno-de-Mesquita B, Buring JE, Campa D, Chanock SJ, Childs EJ, Duell EJ, Fuchs CS, Gaziano JM, Giovannucci EL, Goggins MG, Hartge P, Hassan MM, Holly EA, Hoover RN, Hung RJ, Kurtz RC, Lee IM, Malats N, Milne RL, Ng K, Oberg AL, Panico S, Peters U, Porta M, Rabe KG, Riboli E, Rothman N, Scelo G, Sesso HD, Silverman DT, Stevens VL, Strobel O, Thompson IM, Tjonneland A, Trichopoulou A, Van Den Eeden SK, Wactawski-Wende J, Wentzensen N, Wilkens LR, Yu H, Yuan F, Zeleniuch-Jacquotte A, Amundadottir LT, Li D, Jacobs EJ, Petersen GM, Wolpin BM, Risch HA, Kraft P, Chatterjee N, Klein AP, Stolzenberg-Solomon RZ. Smoking modifies pancreatic cancer risk loci on 2q21.3. Cancer Res 2021:canres.3267.2020. doi: 10.1158/0008-5472.CAN-20-3267. PMCID: PMC Journal in Process. In Press.

Corlin L, Ruan M, Tsilidis KK, Bouras E, Yu Y-H, Stolzenberg-Solomon R, Klein AP, Risch HA,Amos CI, Sakoda LC, Vodi ka P, Rish PK, Beck J, Platz EA, Michaud DS. Two-Sample Mendelian Randomization Analysis of Associations Between Periodontal Disease and Risk of Cancer. Accepted for Publication, JNCI Cancer Spectrum. PMCID: PMC Journal in Process.

Lakeman IMM, van den Broek AJ, Vos J, Barnes DR, Adlard J, Andrulis IL, Arason A, Arnold N, Arun BK, Balmaña J, Barrowdale D, Benitez J, Borg A, Caldés T, Caligo MA, Chung WK, Claes KBM, GEMO Study Collaborators-, EMBRACE Collaborators, Collée JM, Couch FJ, Daly MB, Dennis J, Dhawan M, Domchek SM, Eeles R, Engel C, Evans DG, Feliubadaló L, Foretova L, Friedman E, Frost D, Ganz PA, Garber J, Gayther SA, Gerdes A-M, Godwin AK, Goldgar DE, Hahnen E, Hake CR, Hamann U, Hogervorst FBL, Hooning MJ, Hopper JL, Hulick PJ, Imyanitov EN, OCGN Investigators, HEBON Investigators, kConFab Investigators, Isaacs C, Izatt L, Jakubowska A, James PA, Janavicius R, Jensen UB, Jiao Y, John EM, Joseph V, Karlan BY, Kets CM, Konstantopoulou I, Kwong A, Legrand C, Leslie G, Lesueur F, Loud JT, Lubi ski J, Manoukian S, McGuffog L, Miller A, Gomes DM, Montagna M, Mouret-Fourme E, Nathanson KL, Neuhausen SL, Nevanlinna H, Yie JNY, Olah E, Olopade OI, Park SK, Parsons MT, Peterlongo P, Piedmonte M, Radice P, Rantala J, Rennert G, Risch HA,Schmutzler RK, Sharma P, Simard J, Singer CF, Stadler Z, Stoppa-Lyonnet D, Sutter C, Tan YY, Teixeira MR, Teo SH, Teulé A, Thomassen M, Thull DL, Tischkowitz M, Toland AE, Tung N, van Rensburg EJ, Vega A, Wappenschmidt B, Devilee P, van Asperen CJ, Bernstein JL, Offit K, Easton DF, Rookus MA, Chenevix-Trench G, Antoniou AC, Robson M, Schmidt MK, Consortium of Investigators of Modifiers of BRCA1 and BRCA2. The predictive ability of the 313-variant-based polygenic risk score for contralateral breast cancer risk prediction in women of European ancestry with a heterozygote BRCA1 or BRCA2 pathogenic variant. Accepted for publication, Genet Med. PMCID: PMC Journal in Process.

2021McCullough PA, Kelly RJ, Ruocco G, Lerma E, Tumlin J, Wheelan KR, Katz N, Lepor NE, Vijay

K, Carter H, Singh B, McCullough SP, Bhambi BK, Palazzuoli A, De Ferrari GM, Milligan GP,

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Safder T, Tecson KM, Wang DD, McKinnon JE, O'Neill WW, Zervos M, Risch HA.Pathophysiological Basis and Rationale for Early Outpatient Treatment of SARS-CoV-2(COVID-19) Infection. Am J Med. 2021;134(1):16-22. doi: 10.1016/j.amjmed.2020.07.003. PMCID: PMC7410805

Kho PF, Amant F, Annibali D, Ashton K, Attia J, Auer PL, Beckmann MW, Black A, Brinton L, Buchanan DD, Chanock SJ, Chen C, Chen MM, Cheng THT, Cook LS, Crous-Bous M, Czene K, De Vivo I, Dennis J, Dörk T, Dowdy SC, Dunning AM, Dürst M, Easton DF, Ekici AB, Fasching PA, Fridley BL, Friedenreich CM, García-Closas M, Gaudet MM, Giles GG, Goode EL, Gorman M, Haiman CA, Hall P, Hankinson SE, Hein A, Hillemanns P, Hodgson S, Hoivik EA, Holliday EG, Hunter DJ, Jones A, Kraft P, Krakstad C, Lambrechts D, Le Marchand L, Liang X, Lindblom A, Lissowska J, Long J, Lu L, Magliocco AM, Martin L, McEvoy M, Milne RL, Mints M, Nassir R, Otton G, Palles C, Pooler L, Proietto T, Rebbeck TR, Renner SP, Risch HA, Rübner M, Runnebaum I, Sacerdote C, Sarto GE, Schumacher F, Scott RJ, Setiawan VW, Shah M, Sheng X, Shu XO, Southey MC, Tham E, Tomlinson I, Trovik J, Turman C, Tyrer JP, Van Den Berg D, Wang Z, Wentzensen N, Xia L, Xiang YB, Yang HP, Yu H, Zheng W, Webb PM, Thompson DJ, Spurdle AB, Glubb DM, O'Mara TA. Mendelian randomization analyses suggest a role for cholesterol in the development of endometrial cancer. Int J Cancer 2021;148(2):307-319. doi: 10.1002/ijc.33206. PMCID: PMC7757859

Glubb DM, Thompson DJ, Aben KKH, Alsulimani A, Amant F, Annibali D, Attia J, Barricarte A, Beckmann MW, Berchuck A, Bermisheva M, Bernardini MQ, Bischof K, Bjorge L, Bodelon C, Brand AH, Brenton JD, Brinton LA, Bruinsma F, Buchanan DD, Burghaus S, Butzow R, Cai H, Carney ME, Chanock SJ, Chen C, Chen XQ, Chen Z, Cook LS, Cunningham JM, De Vivo I, deFazio A, Doherty JA, Dörk T, du Bois A, Dunning AM, Dürst M, Edwards T, Edwards RP, Ekici AB, Ewing A, Fasching PA, Ferguson S, Flanagan JM, Fostira F, Fountzilas G, Friedenreich CM, Gao B, Gaudet MM, Gawełko J, Gentry-Maharaj A, Giles GG, Glasspool R, Goodman MT, Gronwald J, Harris HR, Harter P, Hein A, Heitz F, Hildebrandt MAT, Hillemanns P, Høgdall E, Høgdall CK, Holliday EG, Huntsman DG, Huzarski T, Jakubowska A, Jensen A, Jones ME, Karlan BY, Karnezis A, Kelley JL, Khusnutdinova E, Killeen JL, Kjaer SK, Klapdor R, Köbel M, Konopka B, Konstantopoulou I, Kopperud RK, Koti M, Kraft P, Kupryjanczyk J, Lambrechts D, Larson MC, Le Marchand L, Lele S, Lester J, Li AJ, Liang D, Liebrich C, Lipworth L, Lissowska J, Lu L, Lu KH, Macciotta A, Mattiello A, May T, McAlpine JN, McGuire V, McNeish IA, Menon U, Modugno F, Moysich KB, Nevanlinna H, Odunsi K, Olsson H, Orsulic S, Osorio A, Palli D, Park-Simon TW, Pearce CL, Pejovic T, Permuth JB, Podgorska A, Ramus SJ, Rebbeck TR, Riggan MJ, Risch HA, Rothstein JH, Runnebaum IB, Scott RJ, Sellers TA, Senz J, Setiawan VW, Siddiqui N, Sieh W, Spiewankiewicz B, Sutphen R, Swerdlow AJ, Szafron LM, Teo SH, Thompson PJ, Thomsen LCV, Titus L, Tone A, Tumino R, Turman C, Vanderstichele A, Edwards DV, Vergote I, Vierkant RA, Wang Z, Wang-Gohrke S, Webb PM; OPAL Study Group; AOCS Group, White E, Whittemore AS, Winham SJ, Wu X, Wu AH, Yannoukakos D, Spurdle AB, O'Mara TA. Cross-Cancer Genome-Wide Association Study of Endometrial Cancer and Epithelial Ovarian Cancer Identifies Genetic Risk Regions Associated with Risk of Both Cancers. Cancer Epidemiol Biomarkers Prev 2021;30(1):217-228. doi: 10.1158/1055-9965.EPI-20-0739.PMCID: PMC Journal in Process.

Streicher SA, Klein AP, Olson SH, Kurtz RC, Amundadottir LT, DeWan AT, Zhao H, Risch HA.A pooled genome-wide association study identifies pancreatic cancer susceptibility loci on chromosome 19p12 and 19p13.3 in the full-Jewish population. Hum Genet 2021;140(2):309-319. doi: 10.1007/s00439-020-02205-8. PMCID: PMC Journal in Process.

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Jordan SJ, Na R, Weiderpass E, Adami HO, Anderson KE, van den Brandt PA, Brinton LA, Chen C, Cook LS, Doherty JA, Du M, Friedenreich CM, Gierach GL, Goodman MT, Krogh V, Levi F, Lu L, Miller AB, McCann SE, Moysich KB, Negri E, Olson SH, Petruzella S, Palmer JR, Parazzini F, Pike MC, Prizment AE, Rebbeck TR, Reynolds P, Ricceri F, Risch HA, Rohan TE, Sacerdote C, Schouten LJ, Serraino D, Setiawan VW, Shu XO, Sponholtz TR, Spurdle AB, Stolzenberg-Solomon RZ, Trabert B, Wentzensen N, Wilkens LR, Wise LA, Yu H, La Vecchia C, De Vivo I, Xu W, Zeleniuch-Jacquotte A, Webb PM. Pregnancy outcomes and risk of endometrial cancer: A pooled analysis of individual participant data in the Epidemiology of Endometrial Cancer Consortium. Int J Cancer 2021;148(9):2068-2078. doi: 10.1002/ijc.33360. PMCID: PMC7969437

Lee AW, Rosenzweig S, Wiensch A; Australian Ovarian Cancer Study Group, Ramus SJ, Menon U, Gentry-Maharaj A, Ziogas A, Anton-Culver H, Whittemore AS, Sieh W, Rothstein JH, McGuire V, Wentzensen N, Bandera EV, Qin B, Terry KL, Cramer DW, Titus L, Schildkraut JM, Berchuck A, Goode EL, Kjaer SK, Jensen A, Jordan SJ, Ness RB, Modugno F, Moysich K, Thompson PJ, Goodman MT, Carney ME, Chang-Claude J, Rossing MA, Harris HR, Doherty JA, Risch HA, Khoja L, Alimujiang A, Phung MT, Brieger K, Mukherjee B, Pharoah PDP, Wu AH, Pike MC, Webb PM, Pearce CL. Expanding Our Understanding of Ovarian Cancer Risk: The Role of Incomplete Pregnancies. J Natl Cancer Inst 2021;113(3):301-308. doi: 10.1093/jnci/djaa099. PMCID: PMC Journal in Process.

Dighe SG, Chen J, Yan L, He Q, Gharahkhani P, Onstad L, Levine DM, Palles C, Ye W, Gammon MD, Iyer PG, Anderson LA, Liu G, Wu AH, Dai JY, Chow WH, Risch HA, Lagergren J, Shaheen NJ, Bernstein L, Corley DA, Prenen H, deCaestecker J, MacDonald D, Moayyedi P, Barr H, Love SB, Chegwidden L, Attwood S, Watson P, Harrison R, Ott K, Moebus S, Venerito M, Lang H, Mayershofer R, Knapp M, Veits L, Gerges C, Weismüller J, Gockel I, Vashist Y, Nöthen MM, Izbicki JR, Manner H, Neuhaus H, Rösch T, Böhmer AC, Hölscher AH, Anders M, Pech O, Schumacher B, Schmidt C, Schmidt T, Noder T, Lorenz D, Vieth M, May A, Hess T, Kreuser N, Becker J, Ell C, Ambrosone CB, Moysich KB, MacGregor S, Tomlinson I, Whiteman DC, Jankowski J, Schumacher J, Vaughan TL, Madeleine MM, Hardie LJ, Buas MF. Germline variation in the insulin-like growth factor pathway and risk of Barrett's esophagus and esophageal adenocarcinoma. Carcinogenesis 2021;42(3):369-377. doi: 10.1093/carcin/bgaa132. PMCID: PMC8052954

López de Maturana E, Rodríguez JA, Alonso L, Lao O, Molina-Montes E, Martín-Antoniano IA,Gómez-Rubio P, Lawlor R, Carrato A, Hidalgo M, Iglesias M, Molero X, Löhr M, Michalski C, Perea J, O'Rorke M, Barberà VM, Tardón A, Farré A, Muñoz-Bellvís L, Crnogorac-Jurcevic T, Domínguez-Muñoz E, Gress T, Greenhalf W, Sharp L, Arnes L, Cecchini L, Balsells J, Costello E, Ilzarbe L, Kleeff J, Kong B, Márquez M, Mora J, O'Driscoll D, Scarpa A, Ye W, Yu J; PanGenEU Investigators, García-Closas M, Kogevinas M, Rothman N, Silverman DT; SBC/EPICURO Investigators, Albanes D, Arslan AA, Beane-Freeman L, Bracci PM, Brennan P, Bueno-de-Mesquita B, Buring J, Canzian F, Du M, Gallinger S, Gaziano JM, Goodman PJ, Gunter M, LeMarchand L, Li D, Neale RE, Peters U, Petersen GM, Risch HA, Sánchez MJ, Shu XO, Thornquist MD, Visvanathan K, Zheng W, Chanock SJ, Easton D, Wolpin BM, Stolzenberg-Solomon RZ, Klein AP, Amundadottir LT, Marti-Renom MA, Real FX, Malats N. A multilayered post-GWAS assessment on genetic susceptibility to pancreatic cancer. Genome Med 2021;13(1):15. doi: 10.1186/s13073-020-00816-4. PMCID: PMC7849104

2020McCullough PA, Alexander PE, Armstrong R, Arvinte C, Bain AF, Bartlett RP, Berkowitz RL,

Berry AC, Borody TJ, Brewer JH, Brufsky AM, Clarke T, Derwand R, Eck A, Eck J, Eisner

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RA, Fareed GC, Farella A, Fonseca SNS, Geyer CE Jr, Gonnering RS, Graves KE, Gross KBV, Hazan S, Held KS, Hight HT, Immanuel S, Jacobs MM, Ladapo JA, Lee LH, Littell J, Lozano I, Mangat HS, Marble B, McKinnon JE, Merritt LD, Orient JM, Oskoui R, Pompan DC, Procter BC, Prodromos C, Rajter JC, Rajter JJ, Ram CVS, Rios SS, Risch HA, Robb MJA, Rutherford M, Scholz M, Singleton MM, Tumlin JA, Tyson BM, Urso RG, Victory K, Vliet EL, Wax CM, Wolkoff AG, Wooll V, Zelenko V. Multifaceted highly targeted sequential multidrug treatment of early ambulatory high-risk SARS-CoV-2 infection (COVID-19). Rev Cardiovasc Med. 2020;21(4):517-530. doi: 10.31083/j.rcm.2020.04.264. *Not a result of NIH funding.

Risch HA. Early Outpatient Treatment of Symptomatic, High-Risk COVID-19 Patients That Should Be Ramped Up Immediately as Key to the Pandemic Crisis. Am J Epidemiol 2020;189(11):1218-1226. doi: 10.1093/aje/kwaa093. PMCID: PMC7546206

Zhang H, Ahearn TU, Lecarpentier J, Barnes D, Beesley J, Qi G, Jiang X, O'Mara TA, Zhao N, Bolla MK, Dunning AM, Dennis J, Wang Q, Ful ZA, Aittomäki K, Andrulis IL, Anton-Culver H, Arndt V, Aronson KJ, Arun BK, Auer PL, Azzollini J, Barrowdale D, Becher H, Beckmann MW, Behrens S, Benitez J, Bermisheva M, Bialkowska K, Blanco A, Blomqvist C, Bogdanova NV, Bojesen SE, Bonanni B, Bondavalli D, Borg A, Brauch H, Brenner H, Briceno I, Broeks A, Brucker SY, Brüning T, Burwinkel B, Buys SS, Byers H, Caldés T, Caligo MA, Calvello M, Campa D, Castelao JE, Chang-Claude J, Chanock SJ, Christiaens M, Christiansen H, Chung WK, Claes KBM, Clarke CL, Cornelissen S, Couch FJ, Cox A, Cross SS, Czene K, Daly MB, Devilee P, Diez O, Domchek SM, Dörk T, Dwek M, Eccles DM, Ekici AB, Evans DG, Fasching PA, Figueroa J, Foretova L, Fostira F, Friedman E, Frost D, Gago-Dominguez M, Gapstur SM, Garber J, García-Sáenz JA, Gaudet MM, Gayther SA, Giles GG, Godwin AK, Goldberg MS, Goldgar DE, González-Neira A, Greene MH, Gronwald J, Guénel P, Häberle L, Hahnen E, Haiman CA, Hake CR, Hall P, Hamann U, Harkness EF, Heemskerk-Gerritsen BAM, Hillemanns P, Hogervorst FBL, Holleczek B, Hollestelle A, Hooning MJ, Hoover RN, Hopper JL, Howell A, Huebner H, Hulick PJ, Imyanitov EN; kConFab Investigators; ABCTB Investigators, Isaacs C, Izatt L, Jager A, Jakimovska M, Jakubowska A, James P, Janavicius R, Janni W, John EM, Jones ME, Jung A, Kaaks R, Kapoor PM, Karlan BY, Keeman R, Khan S, Khusnutdinova E, Kitahara CM, Ko YD, Konstantopoulou I, Koppert LB, Koutros S, Kristensen VN, Laenkholm AV, Lambrechts D, Larsson SC, Laurent-Puig P, Lazaro C, Lazarova E, Lejbkowicz F, Leslie G, Lesueur F, Lindblom A, Lissowska J, Lo WY, Loud JT, Lubinski J, Lukomska A, MacInnis RJ, Mannermaa A, Manoochehri M, Manoukian S, Margolin S, Martinez ME, Matricardi L, McGuffog L, McLean C, Mebirouk N, Meindl A, Menon U, Miller A, Mingazheva E, Montagna M, Mulligan AM, Mulot C, Muranen TA, Nathanson KL, Neuhausen SL, Nevanlinna H, Neven P, Newman WG, Nielsen FC, Nikitina-Zake L, Nodora J, Offit K, Olah E, Olopade OI, Olsson H, Orr N, Papi L, Papp J, Park-Simon TW, Parsons MT, Peissel B, Peixoto A, Peshkin B, Peterlongo P, Peto J, Phillips KA, Piedmonte M, Plaseska-Karanfilska D, Prajzendanc K, Prentice R, Prokofyeva D, Rack B, Radice P, Ramus SJ, Rantala J, Rashid MU, Rennert G, Rennert HS, Risch HA, Romero A, Rookus MA, Rübner M, Rüdiger T, Saloustros E, Sampson S, Sandler DP, Sawyer EJ, Scheuner MT, Schmutzler RK, Schneeweiss A, Schoemaker MJ, Schöttker B, Schürmann P, Senter L, Sharma P, Sherman ME, Shu XO, Singer CF, Smichkoska S, Soucy P, Southey MC, Spinelli JJ, Stone J, Stoppa-Lyonnet D; EMBRACE Study; GEMO Study Collaborators, Swerdlow AJ, Szabo CI, Tamimi RM, Tapper WJ, Taylor JA, Teixeira MR, Terry M, Thomassen M, Thull DL, Tischkowitz M, Toland AE, Tollenaar RAEM, Tomlinson I, Torres D, Troester MA, Truong T, Tung N, Untch M, Vachon CM, van den Ouweland AMW, van der Kolk LE, van Veen EM, vanRensburg EJ, Vega A, Wappenschmidt B, Weinberg CR, Weitzel

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JN, Wildiers H, Winqvist R, Wolk A, Yang XR, Yannoukakos D, Zheng W, Zorn KK, Milne RL, Kraft P, Simard J, Pharoah PDP, Michailidou K, Antoniou AC, Schmidt MK, Chenevix-Trench G, Easton DF, Chatterjee N, García-Closas M. Genome-wide association study identifies 32 novel breast cancer susceptibility loci from overall and subtype-specific analyses. Nat Genet 2020;52(6):572-581. doi: 10.1038/s41588-020-0609-2. PMCID: PMC7808397

Babic A, Sasamoto N, Rosner BA, Tworoger SS, Jordan SJ, Risch HA, Harris HR, Rossing MA, Doherty JA, Fortner RT, Chang-Claude J, Goodman MT, Thompson PJ, Moysich KB, Ness RB, Kjaer SK, Jensen A, Schildkraut JM, Titus LJ, Cramer DW, Bandera EV, Qin B, Sieh W, McGuire V, Sutphen R, Pearce CL, Wu AH, Pike M, Webb PM, Modugno F, Terry KL. Association Between Breastfeeding and Ovarian Cancer Risk. JAMA Oncol 2020;6(6):e200421. doi: 10.1001/jamaoncol.2020.0421. PMCID: PMC7118668

Fachal L, Aschard H, Beesley J, Barnes DR, Allen J, Kar S, Pooley KA, Dennis J, Michailidou K, Turman C, Soucy P, Lemaçon A, Lush M, Tyrer JP, Ghoussaini M, Moradi Marjaneh M, Jiang X, Agata S, Aittomäki K, Alonso MR, Andrulis IL, Anton-Culver H, Antonenkova NN, Arason A, Arndt V, Aronson KJ, Arun BK, Auber B, Auer PL, Azzollini J, Balmaña J, Barkardottir RB, Barrowdale D, Beeghly-Fadiel A, Benitez J, Bermisheva M, Białkowska K, Blanco AM, Blomqvist C, Blot W, Bogdanova NV, Bojesen SE, Bolla MK, Bonanni B, Borg A, Bosse K, Brauch H, Brenner H, Briceno I, Brock IW, Brooks-Wilson A, Brüning T, Burwinkel B, Buys SS, Cai Q, Caldés T, Caligo MA, Camp NJ, Campbell I, Canzian F, Carroll JS, Carter BD, Castelao JE, Chiquette J, Christiansen H, Chung WK, Claes KBM, Clarke CL; GEMO Study Collaborators; EMBRACE Collaborators, Collée JM, Cornelissen S, Couch FJ, Cox A, Cross SS, Cybulski C, Czene K, Daly MB, de la Hoya M, Devilee P, Diez O, Ding YC, Dite GS, Domchek SM, Dörk T, Dos-Santos-Silva I, Droit A, Dubois S, Dumont M, Duran M, Durcan L, Dwek M, Eccles DM, Engel C, Eriksson M, Evans DG, Fasching PA, Fletcher O, Floris G, Flyger H, Foretova L, Foulkes WD, Friedman E, Fritschi L, Frost D, Gabrielson M, Gago-Dominguez M, Gambino G, Ganz PA, Gapstur SM, Garber J, García-Sáenz JA, Gaudet MM, Georgoulias V, Giles GG, Glendon G, Godwin AK, Goldberg MS, Goldgar DE, González-Neira A, Tibiletti MG, Greene MH, Grip M, Gronwald J, Grundy A, Guénel P, Hahnen E, Haiman CA, Håkansson N, Hall P, Hamann U, Harrington PA, Hartikainen JM, Hartman M, He W, Healey CS, Heemskerk-Gerritsen BAM, Heyworth J, Hillemanns P, Hogervorst FBL, Hollestelle A, Hooning MJ, Hopper JL, Howell A, Huang G, Hulick PJ, Imyanitov EN; KConFab Investigators; HEBON Investigators; ABCTB Investigators, Isaacs C, Iwasaki M, Jager A, Jakimovska M, Jakubowska A, James PA, Janavicius R, Jankowitz RC, John EM, Johnson N, Jones ME, Jukkola-Vuorinen A, Jung A, Kaaks R, Kang D, Kapoor PM, Karlan BY, Keeman R, Kerin MJ, Khusnutdinova E, Kiiski JI, Kirk J, Kitahara CM, Ko YD, Konstantopoulou I, Kosma VM, Koutros S, Kubelka-Sabit K, Kwong A, Kyriacou K, Laitman Y, Lambrechts D, Lee E, Leslie G, Lester J, Lesueur F, Lindblom A, Lo WY, Long J, Lophatananon A, Loud JT, Lubi ski J, MacInnis RJ, Maishman T, Makalic E, Mannermaa A, Manoochehri M, Manoukian S, Margolin S, Martinez ME, Matsuo K, Maurer T, Mavroudis D, Mayes R, McGuffog L, McLean C, Mebirouk N, Meindl A, Miller A, Miller N, Montagna M, Moreno F, Muir K, Mulligan AM, Muñoz-Garzon VM, Muranen TA, Narod SA, Nassir R, Nathanson KL, Neuhausen SL, Nevanlinna H, Neven P, Nielsen FC, Nikitina-Zake L, Norman A, Offit K, Olah E, Olopade OI, Olsson H, Orr N, Osorio A, Pankratz VS, Papp J, Park SK, Park-Simon TW, Parsons MT, Paul J, Pedersen IS, Peissel B, Peshkin B, Peterlongo P, Peto J, Plaseska-Karanfilska D, Prajzendanc K, Prentice R, Presneau N, Prokofyeva D, Pujana MA, Pylkäs K, Radice P, Ramus SJ, Rantala J, Rau-Murthy R, Rennert G, Risch HA, Robson M, Romero A, Rossing M, Saloustros E, Sánchez-Herrero E, Sandler DP, Santamariña M,

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Saunders C, Sawyer EJ, Scheuner MT, Schmidt DF, Schmutzler RK, Schneeweiss A, Schoemaker MJ, Schöttker B, Schürmann P, Scott C, Scott RJ, Senter L, Seynaeve CM, Shah M, Sharma P, Shen CY, Shu XO, Singer CF, Slavin TP, Smichkoska S, Southey MC, Spinelli JJ, Spurdle AB, Stone J, Stoppa-Lyonnet D, Sutter C, Swerdlow AJ, Tamimi RM, Tan YY, Tapper WJ, Taylor JA, Teixeira MR, Tengström M, Teo SH, Terry MB, Teulé A, Thomassen M, Thull DL, Tischkowitz M, Toland AE, Tollenaar RAEM, Tomlinson I, Torres D, Torres-Mejía G, Troester MA, Truong T, Tung N, Tzardi M, Ulmer HU, Vachon CM, van Asperen CJ, van der Kolk LE, van Rensburg EJ, Vega A, Viel A, Vijai J, Vogel MJ, Wang Q, Wappenschmidt B, Weinberg CR, Weitzel JN, Wendt C, Wildiers H, Winqvist R, Wolk A, Wu AH, Yannoukakos D, Zhang Y, Zheng W, Hunter D, Pharoah PDP, Chang-Claude J, García-Closas M, Schmidt MK, Milne RL, Kristensen VN, French JD, Edwards SL, Antoniou AC, Chenevix-Trench G, Simard J, Easton DF, Kraft P, Dunning AM. Fine-mapping of 150 breast cancer risk regions identifies 191 likely target genes. Nat Genet 2020;52(1):56-73. doi: 10.1038/s41588-019-0537-1. PMCID: PMC6974400

Feng H, Gusev A, Pasaniuc B, Wu L, Long J, Abu-Full Z, Aittomäki K, Andrulis IL, Anton-Culver H, Antoniou AC, Arason A, Arndt V, Aronson KJ, Arun BK, Asseryanis E, Auer PL, Azzollini J, Balmaña J, Barkardottir RB, Barnes DR, Barrowdale D, Beckmann MW, Behrens S, Benitez J, Bermisheva M, Białkowska K, Blanco A, Blomqvist C, Boeckx B, Bogdanova NV, Bojesen SE, Bolla MK, Bonanni B, Borg A, Brauch H, Brenner H, Briceno I, Broeks A, Brüning T, Burwinkel B, Cai Q, Caldés T, Caligo MA, Campbell I, Canisius S, Campa D, Carter BD, Carter J, Castelao JE, Chang-Claude J, Chanock SJ, Christiansen H, Chung WK, Claes KBM, Clarke CL; GEMO Study Collaborators; EMBRACE Collaborators; GC-HBOC study Collaborators, Couch FJ, Cox A, Cross SS, Cybulski C, Czene K, Daly MB, de la Hoya M, De Leeneer K, Dennis J, Devilee P, Diez O, Domchek SM, Dörk T, Dos-Santos-Silva I, Dunning AM, Dwek M, Eccles DM, Ejlertsen B, Ellberg C, Engel C, Eriksson M, Fasching PA, Fletcher O, Flyger H, Fostira F, Friedman E, Fritschi L, Frost D, Gabrielson M, Ganz PA, Gapstur SM, Garber J, García-Closas M, García-Sáenz JA, Gaudet MM, Giles GG, Glendon G, Godwin AK, Goldberg MS, Goldgar DE, González-Neira A, Greene MH, Gronwald J, Guénel P, Haiman CA, Hall P, Hamann U, Hake C, He W, Heyworth J, Hogervorst FBL, Hollestelle A, Hooning MJ, Hoover RN, Hopper JL, Huang G, Hulick PJ, Humphreys K, Imyanitov EN; ABCTB Investigators; HEBON Investigators; BCFR Investigators; OCGN Investigators, Isaacs C, Jakimovska M, Jakubowska A, James P, Janavicius R, Jankowitz RC, John EM, Johnson N, Joseph V, Jung A, Karlan BY, Khusnutdinova E, Kiiski JI, Konstantopoulou I, Kristensen VN, Laitman Y, Lambrechts D, Lazaro C, Leroux D, Leslie G, Lester J, Lesueur F, Lindor N, Lindström S, Lo WY, Loud JT, Lubi ski J, Makalic E, Mannermaa A, Manoochehri M, Manoukian S, Margolin S, Martens JWM, Martinez ME, Matricardi L, Maurer T, Mavroudis D, McGuffog L, Meindl A, Menon U, Michailidou K, Kapoor PM, Miller A, Montagna M, Moreno F, Moserle L, Mulligan AM, Muranen TA, Nathanson KL, Neuhausen SL, Nevanlinna H, Nevelsteen I, Nielsen FC, Nikitina-Zake L, Offit K, Olah E, Olopade OI, Olsson H, Osorio A, Papp J, Park-Simon TW, Parsons MT, Pedersen IS, Peixoto A, Peterlongo P, Peto J, Pharoah PDP, Phillips KA, Plaseska-Karanfilska D, Poppe B, Pradhan N, Prajzendanc K, Presneau N, Punie K, Pylkäs K, Radice P, Rantala J, Rashid MU, Rennert G, Risch HA, Robson M, Romero A, Saloustros E, Sandler DP, Santos C, Sawyer EJ, Schmidt MK, Schmidt DF, Schmutzler RK, Schoemaker MJ, Scott RJ, Sharma P, Shu XO, Simard J, Singer CF, Skytte AB, Soucy P, Southey MC, Spinelli JJ, Spurdle AB, Stone J, Swerdlow AJ, Tapper WJ, Taylor JA, Teixeira MR, Terry MB, Teulé A, Thomassen M, Thöne K, Thull DL, Tischkowitz M, Toland AE, Tollenaar RAEM, Torres D, Truong T, Tung N, Vachon CM, van Asperen CJ, van den

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Ouweland AMW, van Rensburg EJ, Vega A, Viel A, Vieiro-Balo P, Wang Q, Wappenschmidt B, Weinberg CR, Weitzel JN, Wendt C, Winqvist R, Yang XR, Yannoukakos D, Ziogas A, Milne RL, Easton DF, Chenevix-Trench G, Zheng W, Kraft P, Jiang X. Transcriptome-wide association study of breast cancer risk by estrogen-receptor status. Genet Epidemiol 2020;44(5):442-468. doi: 10.1002/gepi.22288. PMCID: PMC7987299

Zhong J, Jermusyk A, Wu L, Hoskins JW, Collins I, Mocci E, Zhang M, Song L, Chung CC, Zhang T, Xiao W, Albanes D, Andreotti G, Arslan AA, Babic A, Bamlet WR, Beane-Freeman L, Berndt S, Borgida A, Bracci PM, Brais L, Brennan P, Bueno-de-Mesquita B, Buring J, Canzian F, Childs EJ, Cotterchio M, Du M, Duell EJ, Fuchs C, Gallinger S, Gaziano JM, Giles GG, Giovannucci E, Goggins M, Goodman GE, Goodman PJ, Haiman C, Hartge P, Hasan M, Helzlsouer KJ, Holly EA, Klein EA, Kogevinas M, Kurtz RJ, LeMarchand L, Malats N, Männistö S, Milne R, Neale RE, Ng K, Obazee O, Oberg AL, Orlow I, Patel AV, Peters U, Porta M, Rothman N, Scelo G, Sesso HD, Severi G, Sieri S, Silverman D, Sund M, Tjønneland A, Thornquist MD, Tobias GS, Trichopoulou A, Van Den Eeden SK, Visvanathan K, Wactawski-Wende J, Wentzensen N, White E, Yu H, Yuan C, Zeleniuch-Jacquotte A, Hoover R, Brown K, Kooperberg C, Risch HA, Jacobs EJ, Li D, Yu K, Shu XO, Chanock SJ, Wolpin BM, Stolzenberg-Solomon RZ, Chatterjee N, Klein AP, Smith JP, Kraft P, Shi J, Petersen GM, Zheng W, Amundadottir LT. A Transcriptome-Wide Association Study Identifies Novel Candidate Susceptibility Genes for Pancreatic Cancer. J Natl Cancer Inst 2020;112(10):1003-1012. doi: 10.1093/jnci/djz246. PMCID: PMC7566474

Barnes DR, Rookus MA, McGuffog L, Leslie G, Mooij TM, Dennis J, Mavaddat N, Adlard J, Ahmed M, Aittomäki K, Andrieu N, Andrulis IL, Arnold N, Arun BK, Azzollini J, Balmaña J, Barkardottir RB, Barrowdale D, Benitez J, Berthet P, Białkowska K, Blanco AM, Blok MJ, Bonanni B, Boonen SE, Borg Å, Bozsik A, Bradbury AR, Brennan P, Brewer C, Brunet J, Buys SS, Caldés T, Caligo MA, Campbell I, Christensen LL, Chung WK, Claes KBM, Colas C; GEMO Study Collaborators; EMBRACE Collaborators, Collonge-Rame MA, Cook J, Daly MB, Davidson R, de la Hoya M, de Putter R, Delnatte C, Devilee P, Diez O, Ding YC, Domchek SM, Dorfling CM, Dumont M, Eeles R, Ejlertsen B, Engel C, Evans DG, Faivre L, Foretova L, Fostira F, Friedlander M, Friedman E, Frost D, Ganz PA, Garber J, Gehrig A, Gerdes AM, Gesta P, Giraud S, Glendon G, Godwin AK, Goldgar DE, González-Neira A, Greene MH, Gschwantler-Kaulich D, Hahnen E, Hamann U, Hanson H, Hentschel J, Hogervorst FBL, Hooning MJ, Horvath J, Hu C, Hulick PJ, Imyanitov EN; kConFab Investigators; HEBON Investigators; GENEPSO Investigators, Isaacs C, Izatt L, Izquierdo A, Jakubowska A, James PA, Janavicius R, John EM, Joseph V, Karlan BY, Kast K, Koudijs M, Kruse TA, Kwong A, Laitman Y, Lasset C, Lazaro C, Lester J, Lesueur F, Liljegren A, Loud JT, Lubi ski J, Mai PL, Manoukian S, Mari V, Mebirouk N, Meijers-Heijboer HEJ, Meindl A, Mensenkamp AR, Miller A, Montagna M, Mouret-Fourme E, Mukherjee S, Mulligan AM, Nathanson KL, Neuhausen SL, Nevanlinna H, Niederacher D, Nielsen FC, Nikitina-Zake L, Noguès C, Olah E, Olopade OI, Ong KR, O'Shaughnessy-Kirwan A, Osorio A, Ott CE, Papi L, Park SK, Parsons MT, Pedersen IS, Peissel B, Peixoto A, Peterlongo P, Pfeiler G, Phillips KA, Prajzendanc K, Pujana MA, Radice P, Ramser J, Ramus SJ, Rantala J, Rennert G, Risch HA,Robson M, Rønlund K, Salani R, Schuster H, Senter L, Shah PD, Sharma P, Side LE, Singer CF, Slavin TP, Soucy P, Southey MC, Spurdle AB, Steinemann D, Steinsnyder Z, Stoppa-Lyonnet D, Sutter C, Tan YY, Teixeira MR, Teo SH, Thull DL, Tischkowitz M, Tognazzo S, Toland AE, Trainer AH, Tung N, van Engelen K, van Rensburg EJ, Vega A, Vierstraete J, Wagner G, Walker L, Wang-Gohrke S, Wappenschmidt B, Weitzel JN, Yadav S, Yang X, Yannoukakos D, Zimbalatti D, Offit K, Thomassen M, Couch FJ, Schmutzler RK, Simard J,

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Easton DF, Chenevix-Trench G, Antoniou AC; Consortium of Investigators of Modifiers of BRCA and BRCA2. Polygenic risk scores and breast and epithelial ovarian cancer risks for carriers of BRCA1 and BRCA2 pathogenic variants. Genet Med 2020 Oct;22(10):1653-1666.doi: 10.1038/s41436-020-0862-x. PMCID: PMC7521995

Szente Fonseca SN, de Queiroz Sousa A, Wolkoff AG, Moreira MS, Pinto BC, Valente Takeda CF, Rebouças E, Vasconcellos Abdon AP, Nascimento ALA, Risch HA. Risk of hospitalization for Covid-19 outpatients treated with various drug regimens in Brazil: Comparative analysis. Travel Med Infect Dis 2020;38:101906. doi: 10.1016/j.tmaid.2020.101906. PMCID: PMC7604153

Xie SH, Fang R, Huang M, Dai J, Thrift AP, Anderson LA, Chow WH, Bernstein L, Gammon MD, Risch HA, Shaheen NJ, Reid BJ, Wu AH, Iyer PG, Liu G, Corley DA, Whiteman DC, Caldas C, Pharoah PD, Hardie LJ, Fitzgerald RC, Shen H, Vaughan TL, Lagergren J. Association Between Levels of Sex Hormones and Risk of Esophageal Adenocarcinoma and Barrett's Esophagus. Clin Gastroenterol Hepatol 2020;18(12):2701-2709.e3. doi: 10.1016/j.cgh.2019.11.030. PMCID: PMC7580878

Lin Y, Nakatochi M, Hosono Y, Ito H, Kamatani Y, Inoko A, Sakamoto H, Kinoshita F, Kobayashi Y, Ishii H, Ozaka M, Sasaki T, Matsuyama M, Sasahira N, Morimoto M, Kobayashi S, Fukushima T, Ueno M, Ohkawa S, Egawa N, Kuruma S, Mori M, Nakao H, Adachi Y, Okuda M, Osaki T, Kamiya S, Wang C, Hara K, Shimizu Y, Miyamoto T, Hayashi Y, Ebi H, Kohmoto T, Imoto I, Kasugai Y, Murakami Y, Akiyama M, Ishigaki K, Matsuda K, Hirata M, Shimada K, Okusaka T, Kawaguchi T, Takahashi M, Watanabe Y, Kuriki K, Kadota A, Okada R, Mikami H, Takezaki T, Suzuki S, Yamaji T, Iwasaki M, Sawada N, Goto A, Kinoshita K, Fuse N, Katsuoka F, Shimizu A, Nishizuka SS, Tanno K, Suzuki K, Okada Y, Horikoshi M, Yamauchi T, Kadowaki T, Yu H, Zhong J, Amundadottir LT, Doki Y, Ishii H, Eguchi H, Bogumil D, Haiman CA, Le Marchand L, Mori M, Risch H, Setiawan VW, Tsugane S, Wakai K, Yoshida T, Matsuda F, Kubo M, Kikuchi S, Matsuo K. Genome-wide association meta-analysis identifies GP2 gene risk variants for pancreatic cancer. Nat Commun 2020;11(1):3175. doi: 10.1038/s41467-020-16711-w. PMCID: PMC7314803

Dong J, Maj C, Tsavachidis S, Ostrom QT, Gharahkhani P, Anderson LA, Wu AH, Ye W, Bernstein L, Borisov O, Schröder J, Chow WH, Gammon MD, Liu G, Caldas C, Pharoah PD, Risch HA, May A, Gerges C, Anders M, Venerito M, Schmidt T, Izbicki JR, Hölscher AH, Schumacher B, Vashist Y, Neuhaus H, Rösch T, Knapp M, Krawitz P, Böhmer A, Iyer PG, Reid BJ, Lagergren J, Shaheen NJ, Corley DA, Gockel I, Fitzgerald RC; Stomach and Oesophageal Cancer Study (SOCS) consortium, Cook MB, Whiteman DC, Vaughan TL, Schumacher J, Thrift AP. Sex-Specific Genetic Associations for Barrett's Esophagus and Esophageal Adenocarcinoma. Gastroenterology 2020;159(6):2065-2076.e1. doi: 10.1053/j.gastro.2020.08.052. PMCID: PMC Journal in Process.

Zhang YD, Hurson AN, Zhang H, Choudhury PP, Easton DF, Milne RL, Simard J, Hall P, Michailidou K, Dennis J, Schmidt MK, Chang-Claude J, Gharahkhani P, Whiteman D, Campbell PT, Hoffmeister M, Jenkins M, Peters U, Hsu L, Gruber SB, Casey G, Schmit SL, O'Mara TA, Spurdle AB, Thompson DJ, Tomlinson I, De Vivo I, Landi MT, Law MH, Iles MM, Demenais F, Kumar R, MacGregor S, Bishop DT, Ward SV, Bondy ML, Houlston R, Wiencke JK, Melin B, Barnholtz-Sloan J, Kinnersley B, Wrensch MR, Amos CI, Hung RJ, Brennan P, McKay J, Caporaso NE, Berndt SI, Birmann BM, Camp NJ, Kraft P, Rothman N, Slager SL, Berchuck A, Pharoah PDP, Sellers TA, Gayther SA, Pearce CL, Goode EL, Schildkraut JM, Moysich KB, Amundadottir LT, Jacobs EJ, Klein AP, Petersen GM, Risch

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HA, Stolzenberg-Solomon RZ, Wolpin BM, Li D, Eeles RA, Haiman CA, Kote-Jarai Z, Schumacher FR, Al Olama AA, Purdue MP, Scelo G, Dalgaard MD, Greene MH, Grotmol T, Kanetsky PA, McGlynn KA, Nathanson KL, Turnbull C, Wiklund F; Breast Cancer Association Consortium (BCAC); Barrett’s and Esophageal Adenocarcinoma Consortium (BEACON); Colon Cancer Family Registry (CCFR); Transdisciplinary Studies of Genetic Variation in Colorectal Cancer (CORECT); Endometrial Cancer Association Consortium (ECAC); Genetics and Epidemiology of Colorectal Cancer Consortium (GECCO); Melanoma Genetics Consortium (GenoMEL); Glioma International Case-Control Study (GICC); International Lung Cancer Consortium (ILCCO); Integrative Analysis of Lung Cancer Etiology and Risk (INTEGRAL) Consortium; International Consortium of Investigators Working on Non-Hodgkin’s Lymphoma Epidemiologic Studies (InterLymph); Ovarian Cancer Association Consortium (OCAC); Oral Cancer GWAS; Pancreatic Cancer Case-Control Consortium (PanC4); Pancreatic Cancer Cohort Consortium (PanScan); Prostate Cancer Association Group to Investigate Cancer Associated Alterations in the Genome (PRACTICAL); Renal Cancer GWAS; Testicular Cancer Consortium (TECAC), Chanock SJ, Chatterjee N, Garcia-Closas M. Assessment of polygenic architecture and risk prediction based on common variants across fourteen cancers. Nat Commun 2020;11(1):3353. doi: 10.1038/s41467-020-16483-3. PMCID: PMC7335068

Yuan F, Hung RJ, Walsh N, Zhang H, Platz EA, Wheeler W, Song L, Arslan AA, Beane Freeman LE, Bracci P, Canzian F, Du M, Gallinger S, Giles GG, Goodman PJ, Kooperberg C, Le Marchand L, Neale RE, Rosendahl J, Scelo G, Shu XO, Visvanathan K, White E, Zheng W, Albanes D, Amiano P, Andreotti G, Babic A, Bamlet WR, Berndt SI, Brennan P, Bueno-de-Mesquita B, Buring JE, Campbell PT, Chanock SJ, Fuchs CS, Gaziano JM, Goggins MG, Hackert T, Hartge P, Hassan MM, Holly EA, Hoover RN, Katzke V, Kirsten H, Kurtz RC, Lee IM, Malats N, Milne RL, Murphy N, Ng K, Oberg AL, Porta M, Rabe KG, Real FX, Rothman N, Sesso HD, Silverman DT, Thompson IM, Wactawski-Wende J, Wang X, Wentzensen N, Wilkens LR, Yu H, Zeleniuch-Jacquotte A, Shi J, Duell EJ, Amundadottir LT, Li D, Petersen GM, Wolpin BM, Risch HA, Yu K, Klein AP, Stolzenberg-Solomon R. Genome-Wide Association Study Data Reveal Genetic Susceptibility to Chronic Inflammatory Intestinal Diseases and Pancreatic Ductal Adenocarcinoma Risk. Cancer Res 2020;80(18):4004-4013.doi: 10.1158/0008-5472.CAN-20-0447. PMCID: PMC7861352

Cristiano S, McKean D, Carey J, Bracci P, Brennan P, Chou M, Du M, Gallinger S, Goggins MG, Hassan MM, Hung RJ, Kurtz RC, Li D, Lu L, Neale R, Olson S, Petersen G, Rabe KG, Fu J, Risch H, Rosner GL, Ruczinski I, Klein AP, Scharpf RB. Bayesian copy number detection and association in large-scale studies. BMC Cancer 2020;20(1):856. doi: 10.1186/s12885-020-07304-3. PMCID: PMC7487704

Tang H, Jiang L, Stolzenberg-Solomon RZ, Arslan AA, Beane Freeman LE, Bracci PM, Brennan P, Canzian F, Du M, Gallinger S, Giles GG, Goodman PJ, Kooperberg C, Le Marchand L, Neale RE, Shu XO, Visvanathan K, White E, Zheng W, Albanes D, Andreotti G, Babic A, Bamlet WR, Berndt SI, Blackford A, Bueno-de-Mesquita B, Buring JE, Campa D, Chanock SJ, Childs E, Duell EJ, Fuchs C, Gaziano JM, Goggins M, Hartge P, Hassam MH, Holly EA, Hoover RN, Hung RJ, Kurtz RC, Lee IM, Malats N, Milne RL, Ng K, Oberg AL, Orlow I, Peters U, Porta M, Rabe KG, Rothman N, Scelo G, Sesso HD, Silverman DT, Thompson IM Jr, Tjønneland A, Trichopoulou A, Wactawski-Wende J, Wentzensen N, Wilkens LR, Yu H, Zeleniuch-Jacquotte A, Amundadottir LT, Jacobs EJ, Petersen GM, Wolpin BM, Risch HA,Chatterjee N, Klein AP, Li D, Kraft P, Wei P. Genome-Wide Gene-Diabetes and Gene-Obesity Interaction Scan in 8,255 Cases and 11,900 Controls from PanScan and PanC4 Consortia.

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Cancer Epidemiol Biomarkers Prev 2020;29(9):1784-1791. doi: 10.1158/1055-9965.EPI-20-0275. PMCID: PMC7483330

Zhu J, Shu X, Guo X, Liu D, Bao J, Milne RL, Giles GG, Wu C, Du M, White E, Risch HA,Malats N, Duell EJ, Goodman PJ, Li D, Bracci P, Katzke V, Neale RE, Gallinger S, Van Den Eeden SK, Arslan AA, Canzian F, Kooperberg C, Beane Freeman LE, Scelo G, Visvanathan K, Haiman CA, Le Marchand L, Yu H, Petersen GM, Stolzenberg-Solomon R, Klein AP, Cai Q, Long J, Shu XO, Zheng W, Wu L. Associations between Genetically Predicted Blood Protein Biomarkers and Pancreatic Cancer Risk. Cancer Epidemiol Biomarkers Prev 2020;29(7):1501-1508. doi: 10.1158/1055-9965.EPI-20-0091. PMCID: PMC7334065

Shen Y, Risch H, Lu L, Ma X, Irwin ML, Lim JK, Taddei T, Pawlish K, Stroup A, Brown R, Wang Z, Jia W, Wong L, Mayne ST, Yu H. Risk factors for hepatocellular carcinoma (HCC) in the northeast of the United States: results of a case-control study. Cancer Causes Control 2020;31(4):321-332. doi: 10.1007/s10552-020-01277-1. PMCID: PMC7136513

Thi-Hai Pham Y, Utuama O, Thomas CE, Park JA, La Vecchia C, Risch HA, Tran CT, Le TV, Boffetta P, Raskin L, Luu HN. High mobility group A protein-2 as a tumor cancer diagnostic and prognostic marker: a systematic review and meta-analysis. Eur J Cancer Prev 2020;29(6):565-581. doi: 10.1097/CEJ.0000000000000602. *Not a result of NIH funding.

Brieger KK, Peterson S, Lee AW, Mukherjee B, Bakulski KM, Alimujiang A, Anton-Culver H, Anglesio MS, Bandera EV, Berchuck A, Bowtell DDL, Chenevix-Trench G, Cho KR, Cramer DW, DeFazio A, Doherty JA, Fortner RT, Garsed DW, Gayther SA, Gentry-Maharaj A, Goode EL, Goodman MT, Harris HR, Høgdall E, Huntsman DG, Shen H, Jensen A, Johnatty SE, Jordan SJ, Kjaer SK, Kupryjanczyk J, Lambrechts D, McLean K, Menon U, Modugno F, Moysich K, Ness R, Ramus SJ, Richardson J, Risch H, Rossing MA, Trabert B, Wentzensen N, Ziogas A, Terry KL, Wu AH, Hanley GE, Pharoah P, Webb PM, Pike MC, Pearce CL; Ovarian Cancer Association Consortium. Menopausal hormone therapy prior to the diagnosis of ovarian cancer is associated with improved survival. Gynecol Oncol 2020;158(3):702-709. doi: 10.1016/j.ygyno.2020.06.481. PMCID: PMC7487048

Modugno F, Fu Z, Jordan SJ, Group A, Chang-Claude J, Fortner RT, Goodman MT, Moysich KB, Schildkraut JM, Berchuck A, Bandera EV, Qin B, Sutphen R, McLaughlin JR, Menon U, Ramus SJ, Gayther SA, Gentry-Maharaj A, Karpinskyj C, Pearce CL, Wu AH, Risch HA,Webb PM. Offspring sex and risk of epithelial ovarian cancer: a multinational pooled analysis of 12 case-control studies. Eur J Epidemiol 2020;35(11):1025-1042. doi: 10.1007/s10654-020-00682-9. PMCID: PMC7981786

Ghoneim DH, Zhu J, Zheng W, Long J, Murff HJ, Ye F, Setiawan VW, Wilkens LR, Khankari NK, Haycock P, Antwi SO, Yang Y, Arslan AA, Beane Freeman LE, Bracci PM, Canzian F, Du M, Gallinger S, Giles GG, Goodman PJ, Kooperberg C, Le Marchand L, Neale RE, Scelo G, Visvanathan K, White E, Albanes D, Amiano P, Andreotti G, Babic A, Bamlet WR, Berndt SI, Brais LK, Brennan P, Bueno-de-Mesquita B, Buring JE, Campbell PT, Rabe KG, Chanock SJ, Duggal P, Fuchs CS, Gaziano JM, Goggins MG, Hackert T, Hassan MM, Helzlsouer KJ, Holly EA, Hoover RN, Katske V, Kurtz RC, Lee IM, Malats N, Milne RL, Murphy N, Oberg AL, Porta M, Rothman N, Sesso HD, Silverman DT, Thompson IM Jr, Wactawski-Wende J, Wang X, Wentzensen N, Yu H, Zeleniuch-Jacquotte A, Yu K, Wolpin BM, Jacobs EJ, Duell EJ, Risch HA, Petersen GM, Amundadottir LT, Kraft P, Klein AP, Stolzenberg-Solomon RZ, Shu XO, Wu L. Mendelian Randomization Analysis of n-6 Polyunsaturated Fatty Acid Levels and Pancreatic Cancer Risk. Cancer Epidemiol Biomarkers Prev 2020;29(12):2735-2739. doi: 10.1158/1055-9965.EPI-20-0651. PMCID: PMC7710600

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Yang T, Tang H, Risch HA, Olson SH, Peterson G, Bracci PM, Gallinger S, Hung RJ, Neale RE, Scelo G, Duell EJ, Kurtz RC, Khaw KT, Severi G, Sund M, Wareham N, Amos CI, Li D, Wei P. Incorporating multiple sets of eQTL weights into gene-by-environment interaction analysis identifies novel susceptibility loci for pancreatic cancer. Genet Epidemiol 2020;44(8):880-892.doi: 10.1002/gepi.22348. PMCID: PMC7657998

Xiao Y, He L, Chang W, Zhang S, Wang R, Chen X, Li X, Wang Z, Risch HA. Self-harm behaviors, suicidal ideation, and associated factors among rural left-behind children in west China. Ann Epidemiol 2020;42:42-49. doi: 10.1016/j.annepidem.2019.12.014. *Not a result of NIH funding.

Shuch B, Li S, Risch H, Bindra RS, McGillivray PD, Gerstein M. Estimation of the carrier frequency of fumarate hydratase alterations and implications for kidney cancer risk in hereditary leiomyomatosis and renal cancer. Cancer 2020;126(16):3657-3666. doi: 10.1002/cncr.32914. *Not a result of NIH funding.

2019Lor GCY, Risch HA, Fung JW, Yeung SLA, Wong IOL, Zheng W, Pang H. Reporting and

guidelines for Mendelian randomization analysis: A systematic review of oncological studies. Cancer Epidemiol 2019;62:101577. doi: 10.1016/j.canep.2019.101577. *Not a result of NIH funding.

Ferreira MA, Gamazon ER, Aittomäki K, Andrulis IL, Anton-Culver H, Arndt V, Aronson KJ, Arun BK, Asseryanis E, Auer PL, Azzollini J, Balmaña J, Barkardottir RB, Barnes DR, Barrowdale D, Beckmann MW, Behrens S, Benitez J, Bermisheva M, Blomqvist C, Bogdanova NV, Bojesen SE, Bolla MK, Borg A, Brauch H, Brenner H, Broeks A, Burwinkel B, Caldés T, Caligo MA, Campbell I, Canzian F, Carter J, Carter BD, Castelao JE, Chang-Claude J, Chanock SJ, Christiansen H, Chung WK, Claes KBM, Clarke CL, Couch FJ, Cox A, Cross SS, Czene K, Daly MB, de la Hoya M, Dennis J, Devilee P, Diez O, Dörk T, Dunning AM, Dwek M, Eccles DM, Ejlertsen B, Ellberg C, Engel C, Eriksson M, Fasching PA, Fletcher O, Flyger H, Friedman E, Frost D, Gabrielson M, Gago-Dominguez M, Ganz PA, Gapstur SM, Garber J, García-Closas M, García-Sáenz JA, Gaudet MM, Giles GG, Glendon G, Godwin AK, Goldberg MS, Goldgar DE, González-Neira A, Greene MH, Gronwald J, Guénel P, Haiman CA, Hall P, Hamann U, He W, Heyworth J, Hogervorst FBL, Hollestelle A, Hoover RN, Hopper JL, Huang G, Hulick PJ, Humphreys K, Imyanitov EN, Isaacs C, Jakimovska M, Jakubowska A, James P, Janavicius R, Jankowitz RC, John EM, Johnson N, Jones ME, Joseph V, Kaczmarek K, Kar S, Karlan BY, Keuhl T, Khusnutdinova E, Kiiski JI, Ko Y-D, Konstantopoulou I, Kristensen VN, Laitman Y, Lambrechts D, Lazaro C, Leslie G, Lester J, Lesueur F, Lindor N, Lindström S, Long J, Loud JT, Lubi ski J, Makalic E, Mannermaa A, Margolin S, Mavroudis D, McGuffog L, Meindl A, Menon U, Michailidou K, Miller A, Montagna M, Moreno F, Moserle L, Mulligan AM, Nathanson KL, Neuhausen SL, Nevanlinna H, Nevelsteen I, Nielsen FC, Nikitina-Zake L, Nussbaum RL, Offit K, Olah E, Olopade OI, Olsson H, Osorio A, Papp J, Park-Simon T-W, Parsons MT, Pedersen IS, Peixoto A, Peterlongo P, Pharoah PDP, Plaseska-Karanfilska D, Poppe B, Prentice R, Presneau N, Radice P, Rantala J, Rennert G, Risch HA,Saloustros E, Sanden K, Sandler DP, Sawyer EJ, Schmidt MK, Schmutzler RK, Sharma P, Shu X-O, Simard J, Singer CF, Soucy P, Southey MC, Spinelli JJ, Spurdle AB, Stone J, Swerdlow AJ, Tapper WJ, Taylor JA, Teixeira MR, Terry MB, Teulé A, Thomassen M, Thöne K, Thull DL, Tischkowitz M, Toland AE, Torres D, Truong T, Tung N, Vachon C, van Asperen CJ, van den Ouweland AMW, van Rensburg EJ, Vega A, Viel A, Wang Q, Wappenschmidt B, Weinberg CR, Weitzel JN, Wendt C, Winqvist R, Yang XR, Yannoukakos D, Ziogas A, GC-HBOC study collaborators, OCGN, HEBON Investigators, GEMO Study Collaborators,

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EMBRACE, BCFR Investigators, kConFab Investigators, ABCTB Investigators, Antoniou AC, Kraft P, Easton DF, Zheng W, Milne RL, Beesley J, Chenevix-Trench G. Genome-wide association and transcriptome studies identify novel putative target genes and risk loci for breast cancer. Nat Commun 2019;10(1):1741. doi: 10.1038/s41467-018-08053-5. PMCID: PMC6465407

Dong J, Gharahkhani P, Chow W-H, Gammon MD, Liu G, Caldas C, Wu AH, Ye W, Onstad L, Anderson LA, Bernstein L, Pharoah PD, Risch HA, Corley DA, Fitzgerald RC, Stomach and Esophageal Cancer Study (SOCS) Consortium, Iyer PG, Reid BJ, Lagergren J, Shaheen NJ, Vaughan TL, MacGregor S, Love S, Palles C, Tomlinson I, Gockel I, May A, Gerges C, Anders M, Böhmer AC, Becker J, Kreuser N, Thieme R, Noder T, Venerito M, Veits L, Schmidt T, Schmidt C, Izbicki JR, Hölscher AH, Lang H, Lorenz D, Schumacher B, Mayershofer R, Vashist Y, Ott K, Vieth M, Weismüller J, Nöthen MM, Moebus S, Knapp M, Peters WHM, Neuhaus H, Rösch T, Ell C, Jankowski J, Schumacher J, Neale RE, Whiteman DC, Thrift AP. Vitamin D status and the risks of Barrett's esophagus and esophageal adenocarcinoma: a Mendelian randomization study. Clin Gastroenterol Hepatol. 2019: S1542-3565(19)30088-6.doi: 10.1016/j.cgh.2019.01.041. PMCID: PMC Journal in Process.

Xiao Y, Yang H, Lu J, Li D, Xu C, Risch HA. Serum gamma-glutamyltransferase and the overall survival of metastatic pancreatic cancer. BMC Cancer 2019;19:1020. doi: 10.1186/s12885-019-6250-8. *Not a result of NIH funding.

Xiao Y, Wang Y, Chang W, Chen Y, Yu Z, Risch H. Factors associated with psychological resilience in left-behind children in southwest China. Asian J Psychiatr 2019;46:1-5. doi: 10.1016/j.ajp.2019.09.014. *Not a result of NIH funding.

Baecker A, Kim S, Risch HA, Nuckols TK, Wu BU, Hendifar AE, Pandol SJ, Pisegna JR, Jeon CY. Do changes in health reveal the possibility of undiagnosed pancreatic cancer? Development of a risk-prediction model based on healthcare claims data. PLoS One2019;14(6):e0218580. doi: 10.1371/journal.pone.0218580. PMCID: PMC6592596.

Chen FC, Childs EJ, Mocci E, Bracci PM, Gallinger S, Li D, Neale R, Olson SH, Scelo G, Bamlet WR, Blackford A, Borges M, Brennan P, Chaffee KG, Duggal P, Hassan M, Holly EA, Hung RJ, Goggins M, Kurtz RC, Oberg AL, Orlow I, Yu H, Petersen GM, Risch HA, Klein AP. Analysis of heritability and genetic architecture of pancreatic cancer: a PanC4 study. Cancer Epidemiol Biomarkers Prev 2019;28(7):1238-45. doi: 10.1158/1055-9965.EPI-18-1235.PMCID: PMC6606380.

Reid BM, Permuth JB, Chen YA, Fridley BL, Iversen E, Chen Z, Jim HS, Vierkant RA, Cunningham JM, Barnholtz Sloan J, Narod S, Risch H, Schildkraut JM, Goode EL, Monteiro ANA, Sellers TA. Genome wide analysis of common copy number variation and epithelial ovarian cancer risk. Cancer Epidemiol Biomarkers Prev 2019;28(7):1117-26. PMCID: PMC Journal in Process.

Buckley MA, Woods NT, Tyrer J, Mendoza-Fandino G, Lawrenson K, Hazelett DJ, Najafabadi HS, Gjyshi A, Carvalho RS, Lyra PC Jr, Coetzee SG, Shen HC, Karevan R, Yang A, Earp M, Chen YA, Yoder SJ, Risch HA, Aben KKH, Anton Culver H, Antonenkova N, Bruinsma F, Bandera EV, Bean YT, Beckmann MW, Bisogna M, Bjorge L, Bogdanova N, Brinton LA, Brooks-Wilson A, Bunker CH, Butzow R, Campbell IG, Carty K, Chang-Claude J, Cook LS, Cramer DW, Cunningham JM, Cybulski C, Dansonka-Mieszkowska A, du Bois A, Dicks E, Doherty JA, Dörk T, Dürst M, Easton DF, Eccles DM, Edwards RP, Ekici AB, Fasching PA, Fridley BL, Gao Y-T, Gentry-Maharaj A, Giles GG, Glasspool R, Goodman MT, Gronwald J, Harter P, Hasmad HN, Hein A, Heitz F, Hildebrandt MAT, Hillemanns P, Hogdall CK, Hogdall

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E, Hosono S, Iversen ES, Jakubowska A, Jensen A, Ji B-T, Karlan BY, Kellar M, Kelley JL, Kiemeney LA, Krakstad C, Kjaer SK, Kupryjanczyk J, Lambrechts D, Lambrechts S, Le ND, Lee AW, Lele S, Leminen A, Lester J, Levine DA, Liang D, Lim BK, Lissowska J, Lu K, Lubinski J, Lundvall L, Massuger LFAG, Matsuo K, McGuire V, McLaughlin JR, McNeish I, Menon U, Milne RL, Modugno F, Moysich KB, Ness RB, Nevanlinna H, Eilber U, Odunsi K, Olson SH, Orlow I, Orsulic S, Weber RP, Paul J, Pearce CL, Pejovic T, Pelttari LM, Permuth-Wey J, Pike MC, Poole EM, Rosen B, Rossing MA, Rothstein JH, Rudolph A, Runnebaum IB, Rzepecka IK, Salvesen HB, Schwaab I, Shu, X-O, Shvetsov YB, Siddiqui N, Sieh W, Song H, Southey MC, Spiewankiewicz B, Sucheston-Campbell L, Teo S-H, Terry KL, Thompson PJ, Thomsen L, Tangen IL, Tsai Y, Tworoger SS, van Altena AM, Van Nieuwenhuysen E, Vergote I, Walsh CS, Wang-Gohrke S, Wentzensen N, Whittemore AS, Wicklund KG, Wilkens LR, Wu AH, Wu X, Woo Y-L, Yang H, Zheng W, Ziogas A, Berchuck A, Chenevix-Trench G, AOCS management group, Schildkraut JM, Ramus SJ, Kelemen LE, Freedman ML, Phelan CM, Coetzee GA, Noushmehr H, Hughes TR, Sellers TA, Goode EL, Pharoah PD, Gayther SA, Monteiro ANA. Functional analysis and fine mapping of the 9p22.2 ovarian cancer susceptibility locus. Cancer Res 2019;79(3):467-81. doi: 10.1158/0008-5472.CAN-17-3864.PMCID: PMC Journal in Process.

Chhoda A, Lu L, Clerkin BM, Risch H, Farrell J. Pancreatic cancer screening: current approaches. Am J Pathol 2019;189(1):22-35. doi: 10.1016/j.ajpath.2018.09.013. *Not a result of NIH funding.

Webb PM, Na R, Weiderpass E, Adami HO, Anderson KE, Bertrand KA, Botteri E, Brasky TM, Brinton LA, Chen C, Doherty JA, Lu L, McCann SE, Moysich KB, Olson S, Petruzella S, Palmer JR, Prizment AE, Schairer C, Setiawan VW, Spurdle AB, Trabert B, Wentzensen N, Wilkens L, Yang HP, Yu H, Risch HA, Jordan SJ. Use of aspirin, other nonsteroidal anti-inflammatory drugs and acetaminophen and risk of endometrial cancer: The Epidemiology of Endometrial Cancer Consortium. Ann Oncol 2019;30(2):310-316. doi: 10.1093/annonc/mdy541. PMCID: PMC Journal in Process.

Jiang X, Finucane HK, Schumacher FR, Schmit SL, Tyrer JP, Han Y, Michailidou K, Lesseur C, Kuchenbaecker KB, Dennis J, Conti DV, Casey G, Gaudet MM, Huyghe JR, Albanes D, Aldrich MC, Andrew AS, Andrulis IL, Anton-Culver H, Antoniou AC, Antonenkova NN, Arnold SM, Aronson KJ, Arun BK, Bandera EV, Barkardottir RB, Barnes DR, Batra J, Beckmann MW, Benitez J, Benlloch S, Berchuck A, Berndt SI, Bickeböller H, Bien SA, Blomqvist C, Boccia S, Bogdanova NV, Bojesen SE, Bolla MK, Brauch H, Brenner H, Brenton JD, Brook MN, Brunet J, Brunnström H, Buchanan DD, Burwinkel B, Butzow R, Cadoni G, Caldés T, Caligo MA, Campbell I, Campbell PT, Cancel-Tassin G, Cannon-Albright L, Campa D, Caporaso N, Carvalho AL, Chan AT, Chang-Claude J, Chanock SJ, Chen C, Christiani DC, Claes KBM, Claessens F, Clements J, Collée JM, Cruz Correa M, Couch FJ, Cox A, Cunningham JM, Cybulski C, Czene K, Daly MB, deFazio A, Devilee P, Diez O, Gago-Dominguez M, Donovan JL, Dörk T, Duell EJ, Dunning AM, Dwek M, Eccles DM, Edlund CK, Velez Edwards DR, Ellberg C, Evans DG, Fasching PA, Ferris RL, Liloglou T, Figueiredo JC, Fletcher O, Fortner RT, Fostira F, Franceschi S, Friedman E, Gallinger SJ, Ganz PA, Garber J, García-Sáenz JA, Gayther SA, Giles GG, Godwin AK, Goldberg MS, Goldgar DE, Goode EL, Goodman MT, Goodman G, Grankvist K, Greene MH, Gronberg H, Gronwald J, Guénel P, Håkansson N, Hall P, Hamann U, Hamdy FC, Hamilton RJ, Hampe J, Haugen A, Heitz F, Herrero R, Hillemanns P, Hoffmeister M, Høgdall E, Hong Y-C, Hopper JL, Houlston R, Hulick PJ, Hunter DJ, Huntsman DG, Idos G, Imyanitov EN, Ingles SA, Isaacs C, Jakubowska A, James P, Jenkins MA, Johansson M, Johansson M, John EM, Joshi AD, Kaneva

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R, Karlan BY, Kelemen LE, Kühl T, Khaw K-T, Khusnutdinova E, Kibel AS, Kiemeney LA, Kim J, Kjaer SK, Knight JA, Kogevinas M, Kote-Jarai Z, Koutros S, Kristensen VN, Kupryjanczyk J, Lacko M, Lam S, Lambrechts D, Landi MT, Lazarus P, Le ND, Lee E, Lejbkowicz F, Lenz H-J, Leslie G, Lessel D, Lester J, Levine DA, Li L, Li CI, Lindblom A, Lindor NM, Liu G, Loupakis F, Lubi ski J, Maehle L, Maier C, Mannermaa A, Le Marchand L, Margolin S, May T, McGuffog L, Meindl A, Middha P, Miller A, Milne RL, MacInnis RJ, Modugno F, Montagna M, Moreno V, Moysich KB, Mucci L, Muir K, Mulligan AM, Nathanson KL, Neal DE, Ness AR, Neuhausen SL, Nevanlinna H, Newcomb PA, Newcomb LF, Nielsen FC, Nikitina-Zake L, Nordestgaard BG, Nussbaum RL, Offit K, Olah E, Al Olama AA, Olopade OI, Olshan AF, Olsson H, Osorio A, Pandha H, Park JY, Pashayan N, Parsons MT, Pejovic T, Penney KL, Peters WHM, Phelan CM, Phipps AI, Plaseska-Karanfilska D, Pring M, Prokofyeva D, Radice P, Stefansson K, Ramus SJ, Raskin L, Rennert G, Rennert HS, van Rensburg EJ, Riggan MJ, Risch HA, Risch A, Roobol MJ, Rosenstein BS, Rossing MA, De Ruyck K, Saloustros E, Sandler DP, Sawyer EJ, Schabath MB, Schleutker J, Schmidt MK, Setiawan VW, Shen H, Siegel EM, Sieh W, Singer CF, Slattery ML, Sorensen KD, Southey MC, Spurdle AB, Stanford JL, Stevens VL, Stintzing S, Stone J, Sundfeldt K, Sutphen R, Swerdlow AJ, Tajara EH, Tangen CM, Tardon A, Taylor JA, Teare MD, Teixeira MR, Terry MB, Terry KL, Thibodeau SN, Thomassen M, Bjørge L, Tischkowitz M, Toland AE, Torres D, Townsend PA, Travis RC, Tung N, Tworoger SS, Ulrich CM, Usmani N, Vachon CM, Van Nieuwenhuysen E, Vega A, Aguado-Barrera ME, Wang Q, Webb PM, Weinberg CR, Weinstein S, Weissler MC, Weitzel JN, West CML, White E, Whittemore AS, Wichmann H-E, Wiklund F, Winqvist R, Wolk A, Woll P, Woods M, Wu AH, Wu X, Yannoukakos D, Zheng W, Zienolddiny S, Ziogas A, Zorn KK, Lane JM, Saxena R, Thomas D, Hung RJ, Diergaarde B, McKay J, Peters U, Hsu L, García Closas M, Eeles RA, Chenevix-Trench G, Brennan PJ, Haiman CA, Simard J, Easton DF, Gruber SB, Pharoah PDP, Price AL, Pasaniuc B, Amos CI, Kraft P, Lindström S. Shared heritability and functional enrichment across six solid cancers. Nat Commun 2019;10(1):431. doi: 10.1038/s41467-018-08054-4. PMCID: PMC Journal in Process.

2018Liu G, Mukherjee B, Lee S, Lee AW, Wu AH, Bandera EV, Jensen A, Rossing MA, Moysich KB,

Chang-Claude J, Doherty J, Gentry-Maharaj A, Kiemeney L, Gayther SA, Modugno F, Massuger L, Goode EL, Fridley B, Terry KL, Cramer DW, Ramus SJ, Anton- Culver H, Ziogas A, Tyrer JP, Schildkraut JM, Kjaer SK, Webb PM, Ness RB, Menon U, Berchuck A, Pharoah PD, Risch H, Pearce CL, Ovarian Cancer Association Consortium. Robust tests for additive gene-environment interaction in case-control studies using gene-environment independence. Am J Epidemiol 2018;187(2):366-77. doi: 10.1093/aje/kwx243. PMCID: PMC Journal in Process.

Harris HR, Babic A, Webb PM, Nagle CM, Jordan SJ, Australian Ovarian Cancer Study Group, Risch HA, Rossing MA, Doherty JA, Goodman MT, Modugno F, Ness RB, Moysich KB, Kjær SK, Høgdall E, Jensen A, Schildkraut JM, Berchuck A, Cramer DW, Bandera EV, Wentzensen N, Kotsopoulos J, Narod SA, Phelan CM, McLaughlin JR, Anton-Culver H, Ziogas A, Pearce CL, Wu AH, Terry KL, Ovarian Cancer Association Consortium. Polycystic ovary syndrome, oligomenorrhea, and risk of ovarian cancer histotypes: Evidence from the Ovarian Cancer Association Consortium. Cancer Epidemiol Biomarkers Prev 2018;27(2):174-82. doi: 10.1158/1055-9965.EPI-17-0655. PMCID: PMC Journal in Process.

Dong J, Buas MF, Gharahkhani P, Kendall BJ, Onstad L, Zhao S, Anderson LA, Wu AH, Ye W, Bird NC, Bernstein L, Chow W-H, Gammon MD, Liu G, Caldas C, Pharoah PD, Risch HA,

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Iyer PG, Reid BJ, Hardie LJ, Lagergren J, Shaheen NJ, Corley DA, Fitzgerald RC, Stomach and Oesophageal Cancer Study (SOCS) Consortium, Whiteman DC, Vaughan TL, Thrift AP. Determining risk of Barrett’s Esophagus and esophageal adenocarcinoma based on epidemiologic factors and genetic variants. Gastroenterology 2018;154(5):1273-81.e3. doi: 10.1053/j.gastro.2017.12.003. PMCID: PMC Journal in Process.

Dong J, Levine DM, Buas MF, Zhang R, Onstad L, Fitzgerald RC, Stomach and Oesophageal Cancer Study (SOCS) Consortium, Corley DA, Shaheen NJ, Lagergren J, Hardie LJ, Reid BJ, Iyer PG, Risch HA, Caldas C, Caldas I, Pharoah PDP, Liu G, Gammon MD, Chow W-H, Bernstein L, Bird NC, Ye W, Wu AH, Anderson LA, MacGregor S, Whiteman DC, Vaughan TL, Thrift AP. Interactions between genetic variants and environmental factors affect risk of esophageal adenocarcinoma and Barrett's Esophagus. Clin Gastroenterol Hepatol 2018;16(10):1598-606.e4. doi: 10.1016/j.cgh.2018.03.007. PMCID: PMC Journal in Process.

Dixon-Suen SC, Nagle CM, Thrift AP, Pharoah PDP, Pirie A, Pearce CL, Zheng W, Australian Ovarian Cancer Study Group, Chenevix-Trench G, Fasching PA, Beckmann MW, Lambrechts D, Vergote I, Lambrechts S, Van Nieuwenhuysen E, Rossing MA, Doherty JA, Wicklund KG, Chang-Claude J, Jung AY, Moysich KB, Odunsi K, Goodman MT, Wilkens LR, Thompson PJ, Shvetsov YB, Dörk T, Park-Simon T-W, Hillemanns P, Bogdanova N, Butzow R, Nevanlinna H, Pelttari LM, Leminen A, Modugno F, Ness RB, Edwards RP, Kelley JL, Heitz F, du Bois A, Harter P, Schwaab I, Karlan BY, Lester J, Orsulic S, Rimel BJ, Kjær SK, Høgdall E, Jensen A, Goode EL, Fridley BL, Cunningham JM, Winham SJ, Giles GG, Bruinsma F, Milne RL, Southey MC, Hildebrandt MAT, Wu X, Lu KH, Liang D, Levine DA, Bisogna M, Schildkraut JM, Berchuck A, Cramer DW, Terry KL, Bandera EV, Olson SH, Salvesen HB, Vestrheim Thomsen LC, Kopperud RK, Bjorge L, Kiemeney LA, Massuger LFAG, Pejovic T, Bruegl A, Cook LS, Le ND, Swenerton KD, Brooks-Wilson A, Kelemen LE, Lubi ski J, Huzarski T, Gronwald J, Menkiszak J, Wentzensen N, Brinton L, Yang H, Lissowska J, Høgdall CK, Lundvall L, Song H, Tyrer JP, Campbell I, Eccles D, Paul J, Glasspool R, Siddiqui N, Whittemore AS, Sieh W, McGuire V, Rothstein JH, Narod SA, Phelan C, Risch HA,McLaughlin JR, Anton-Culver H, Ziogas A, Menon U, Gayther SA, Ramus SJ, Gentry-Maharaj A, Wu AH, Pike MC, Tseng C-C, Kupryjanczyk J, Dansonka-Mieszkowska A, Budzilowska A, Rzepecka IK, Webb PM, Ovarian Cancer Association Consortium. Adult height is associated with increased risk of ovarian cancer: a Mendelian randomisation study. Br J Cancer 2018;118(8):1123-9. doi: 10.1038/s41416-018-0011-3. PMCID: PMC Journal in Process.

Antwi SO, Bamlet WR, Pedersen KS, Chaffee KG, Risch HA, Shivappa N, Steck SE, Anderson KE, Bracci PM, Polesel J, Serraino D, La Vecchia C, Bosetti C, Li D, Oberg AL, Arslan AA, Albanes D, Duell EJ, Huybrechts I, Amundadottir LT, Hoover R, Mannisto S, Chanock S, Zheng W, Shu X-O, Stepien M, Canzian F, Bueno-de-Mesquita B, Quirós JR, Zeleniuch-Jacquotte A, Bruinsma F, Milne RL, Giles GG, Hébert JR, Stolzenberg-Solomon RZ, Petersen GM. Pancreatic cancer risk is modulated by inflammatory potential of diet and ABO genotype: A consortia-based evaluation and replication study. Carcinogenesis. 2018:bgy072. doi: 10.1093/carcin/bgy072. PMCID: PMC Journal in Process.

Earp M, Tyrer JP, Winham SJ, Lin H-Y, Chornokur G, Dennis J, Aben KKH, Anton Culver H, Antonenkova N, Bandera EV, Bean YT, Beckmann MW, Bjorge L, Bogdanova N, Brinton LA, Brooks-Wilson A, Bruinsma F, Bunker CH, Butzow R, Campbell- IG, Carty K, Chang-Claude J, Cook LS, Cramer DW, Cunningham JM, Cybulski C, Dansonka-Mieszkowska A, Despierre E, Doherty JA, Dörk T, du Bois A, Dürst M, Easton DF, Eccles DM, Edwards RP, Ekici AB, Fasching PA, Fridley BL, Gentry-Maharaj A, Giles GG, Glasspool R, Goodman MT, Gronwald J, Harter P, Hein A, Heitz F, Hildebrandt MAT, Hillemanns P, Hogdall CK, Høgdall E, Hosono

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S, Iversen ES, Jakubowska A, Jensen A, Ji B-T, Jung AY, Karlan BY, Kellar M, Kiemeney LA, Lim BK, Kjaer SK, Krakstad C, Kupryjanczyk J, Lambrechts D, Lambrechts S, Le ND, Lele S, Lester J, Levine DA, Li Z, Liang D, Lissowska J, Lu K, Lubinski J, Lundvall L, Massuger LFAG, Matsuo K, McGuire V, McLaughlin JR, McNeish I, Menon U, Milne RL, Modugno F, Moysich KB, Ness RB, Nevanlinna H, Odunsi K, Olson SH, Orlow I, Orsulic S, Paul J, Pejovic T, Pelttari LM, Permuth JB, Pike MC, Poole EM, Rosen B, Rossing MA, Rothstein JH, Runnebaum IB, Rzepecka IK, Schernhammer E, Schwaab I, Shu X-O, Shvetsov YB, Siddiqui N, Sieh W, Song H, Southey MC, Spiewankiewicz B, Sucheston-Campbell L, Tangen IL, Teo S-H, Terry KL, Thompson PJ, Thomsen L, Tworoger SS, van Altena AM, Vergote I, Vestrheim Thomsen LC, Vierkant RA, Walsh CS, Wang-Gohrke S, Wentzensen N, Whittemore AS, Wicklund KG, Wilkens LR, Woo Y-L, Wu AH, Wu X, Xiang Y-B, Yang H, Zheng W, Ziogas A, Lee AW, Pearce CL, Berchuck A, Schildkraut JM, Ramus SJ, Monteiro ANA, Narod SA, Sellers TA, Gayther SA, Kelemen LE, Chenevix-Trench G, Risch HA, Pharoah PDP, Goode EL, Phelan CM. Variants in genes encoding small GTPases and association with epithelial ovarian cancer susceptibility. PLoS One 2018;13(7):e0197561. doi: 10.1371/journal.pone.0197561. PMCID: PMC Journal in Process.

Mukhtar F, Boffetta P, Dabo B, Park JY, Tran TV, Tran HT-T, Whitney M, Risch HA, Le LC, Zheng W, Shu X-O, Luu HN. Disparities by race, age, and sex in the improvement of survival for lymphoma. PLoS One 2018;13(7):e0199745. doi: 10.1371/journal.pone.0199745. *Not a result of NIH funding.

Lu Y, Beeghly-Fadiel A, Wu L, Guo X, Li B, Moysich KB, Im HK, Andrulis IL, Anton-Culver H, Arun BK, Bandera EV, Barkardottir RB, Barnes DR, Barnes D, Benitez J, Bjorge L, Brenton J, Butzow R, Caldes T, Caligo MA, Campbell I, Chang-Claude J, Claes KBM, Couch FJ, Cramer DW, Daly MB, deFazio A, Dennis J, Diez O, Domchek SM, Dörk T, Easton DF, Eccles DM, Fasching PA, Fortner RT, Fountzilas G, Friedman E, Ganz PA, Garber J, Giles GG, Godwin AK, Goldgar DE, Goodman MT, Greene MH, Gronwald J, Hamann U, Heitz F, Hildebrandt MAT, Høgdall CK, Hollestelle A, Hulick PJ, Huntsman DG, Imyanitov EN, Isaacs C, Jakubowska A, James P, Karlan BY, Kelemen LE, Kiemeney LA, Kjaer SK, Kupryjanczyk J, Kwong A, Lambrechts D, Le ND, Leslie G, Lesueur F, Levine DA, May T, McGuffog L, McNeish I, Modugno F, Montagna M, Neuhausen SL, Nevanlinna H, Nielsen FC, Nikitina-Zake L, Nussbaum RL, Offit K, Olah E, Olopade OI, Olson SH, Olsson H, Osorio A, Park SK, Parsons M, Peeters PHM, Pejovic T, Peterlongo P, Phelan CM, Pujana MA, Ramus SJ, Rennert G, Riboli E, Risch H, Rodriguez GC, Rodríguez-Antona C, Romieu I, Rookus MA, Rossing MA, Sandler DP, Schmutzler RK, Setiawan VW, Sharma P, Sieh W, Simard J, Singer CF, Song H, Southey MC, Spurdle AB, Sutphen R, Swerdlow AJ, Teixeira MR, Teo SH, Thomassen M, Tischkowitz M, Toland AE, Tung N, Tworoger SS, van Rensburg EJ, Vega A, Edwards DV, Webb PM, Weitzel JN, Wentzensen N, White E, Wolk A, Wu AH, Yannoukakos D, Zorn KK, BCFR, EMBRACE, GEMO Study Collaborators, HEBON, KConFab Investigators, SWE-BRCA, Mod SQuaD study collaborators, GC-HBOC study collaborators, CONSIT study collaborators, Gayther SA, Antoniou AC, Berchuck A, Goode EL, Chenevix-Trench G, Sellers TA, Pharoah PDP, Zheng W, Long J. A transcriptome-wide association study among 97,898 women to identify candidate susceptibility genes for epithelial ovarian cancer risk. Cancer Res 2018;78(18):5419-30. doi: 10.1158/0008-5472.CAN-18-0951. PMCID: PMC Journal in Process.

O'Mara TA, Glubb DM, Amant F, Annibali D, Ashton K, Attia J, Auer PL, Beckmann MW, Black A, Bolla MK, Brauch H, Brenner H, Brinton L, Buchanan DD, Burwinkel B, Chang-Claude J, Chanock SJ, Chen C, Chen MM, Cheng THT, Clarke CL, Clendenning M, Cook LS, Couch FJ,

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Cox A, Crous-Bous M, Czene K, Day F, Dennis J, Depreeuw J, Doherty JA, Dörk T, Dowdy SC, Dürst M, Ekici AB, Fasching PA, Fridley BL, Friedenreich CM, Fritschi L, Fung J, García-Closas M, Gaudet MM, Giles GG, Goode EL, Gorman M, Haiman CA, Hall P, Hankinson S, Healey CS, Hein A, Hillemanns P, Hodgson S, Hoivik E, Holliday EG, Hopper JL, Hunter DJ, Jones A, Krakstad C, Kristensen VN, Lambrechts D, Le Marchand L, Liang X, Lindblom A, Lissowska J, Long J, Lu L, Magliocco AM, Martin L, McEvoy M, Meindl A, Michailidou K, Milne RL, Mints M, Montgomery GW, Nassir R, Olsson H, Orlow I, Otton G, Palles C, Perry JRB, Peto J, Pooler L, Prescott J, Proietto T, Rebbeck TR, Risch HA, Rogers PAW, Rübner M, Runnebaum I, Sacerdote C, Sarto GE, Schumacher F, Scott RJ, Setiawan VW, Shah M, Sheng X, Shu X-O, Southey MC, Swerdlow AJ, Tham E, Trovik J, Turman C, Tyrer JP, Vachon C, VanDen Berg D, Vanderstichele A, Wang Z, Webb PM, Wentzensen N, Werner HMJ, Winham SJ, Wolk A, Xia L, Xiang Y-B, Yang HP, Yu H, Zheng W, National Study of Endometrial Cancer Genetics Group (NSECG), RENDOCAS, The Australian National Endometrial Cancer Study Group (ANECS), CHIBCHA Consortium, Pharoah PDP, Dunning AM, Kraft P, De Vivo I, Tomlinson I, Easton DF, Spurdle AB, Thompson DJ. Identification of nine new susceptibility loci for endometrial cancer. Nat Commun 2018;9(1):3166. doi: 10.1038/s41467-018-05427-7. PMCID: PMC Journal in Process.

Kelemen LE, Earp M, Fridley BL, Chenevix-Trench G, Australian Ovarian Cancer Study Group, Fasching PA, Beckmann MW, Ekici AB, Hein A, Lambrechts D, Lambrechts S, Van Nieuwenhuysen E, Vergote I, Rossing MA, Doherty JA, Chang-Claude J, Behrens S, Moysich KB, Cannioto R, Lele S, Odunsi K, Goodman MT, Shvetsov YB, Thompson PJ, Wilkens LR, Dörk T, Antonenkova N, Bogdanova N, Hillemanns P, Runnebaum IB, du Bois A, Harter P, Heitz F, Schwaab I, Butzow R, Pelttari LM, Nevanlinna H, Modugno F, Edwards RP, Kelley JL, Ness RB, Karlan BY, Lester J, Orsulic S, Walsh C, Kjaer SK, Jensen A, Cunningham JM, Vierkant RA, Giles GG, Bruinsma F, Southey MC, Hildebrandt MAT, Liang D, Lu K, Wu X, Sellers TA, Levine DA, Schildkraut JM, Iversen ES, Terry KL, Cramer DW, Tworoger SS, Poole EM, Bandera EV, Olson SH, Orlow I, Vestrheim LC, Bjorge L, Krakstad C, Tangen IL, Kiemeney LA, Aben KKH, Massuger LFAG, van Altena AM, Pejovic T, Bean Y, Kellar M, Cook LS, Le ND, Brooks-Wilson A, Gronwald J, Cybulski C, Jakubowska A, Lubi ski J, Wentzensen N, Brinton LA, Lissowska J, Hogdall E, Engelholm SA, Hogdall C, Lundvall L, Nedergaard L, Pharoah PDP, Dicks E, Song H, Tyrer JP, McNeish I, Siddiqui N, Carty K, Glasspool R, Paul J, Campbell IG, Eccles D, Whittemore AS, McGuire V, Rothstein JH, Sieh W, Narod SA, Phelan CM, McLaughlin JR, Risch HA, Anton-Culver H, Ziogas A, Menon U, Gayther SA, Gentry-Maharaj A, Ramus SJ, Wu AH, Pearce CL, Lee AW, Pike MC, Kupryjanczyk J, Podgorska A, Plisiecka-Halasa J, Sawicki W, Goode EL, Berchuck A, Ovarian Cancer Association Consortium. rs495139 in the TYMS-ENOSF1 region and risk of ovarian carcinoma of mucinous histology. Int J Mol Sci 2018;19(9). pii: E2473. doi: 10.3390/ijms19092473. PMCID: PMC Journal in Process.

Visvanathan K, Shaw P, May B, Bahadirli-Talbot A, Kaushiva A, Risch H, Narod S, Wang T-L, Parkash V, Vang R, Levine D, Soslow R, Kurman R, Shih I-M. Fallopian tube lesions in women at high risk for ovarian cancer: A multicenter study. Accepted for publication, Cancer Prev Res (Phila) 2018;11(11):697-706. doi: 10.1158/1940-6207.CAPR-18-0009. PMCID: PMC Journal in Process.

Walsh N, Zhang H, Hyland P, Yang Q, Mocci E, Zhang M, Childs EJ, Collins I, Wang Z, Arslan AA, Beane-Freeman L, Bracci PM, Canzian F, Duell EJ, Gallinger S, Giles GG, Goodman GE, Goodman PJ, Kooperberg C, LeMarchand L, Neale RE, Olson SH, Scelo G, Shu XO, Van Den Eeden SK, Visvanathan K, White E, Zheng W, Albanes D, Andreotti G, Babic A, Bamlet WR,

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Berndt SI, Borgida A, Boutron-Ruault MC, Brais L, Brennan P, Bueno de-Mesquita B, Buring J, Chaffee KG, Chanock S, Cleary S, Cotterchio M, Foretova L, Fuchs C, Gaziano JMM, Giovannucci E, Goggins M, Hackert T, Haiman C, Hartge P, Hasan M, Helzlsouer KJ, Herman J, Holcatova I, Holly EA, Hoover R, Hung RJ, Janout V, Klein EA, Kurtz RC, Laheru D, Lee I-M, Lu L, Malats N, Mannisto S, Milne RL, Oberg AL, Orlow I, Patel AV, Peters U, Porta M, Real FX, Rothman N, Sesso HD, Severi G, Silverman D, Strobel O, Sund M, Thornquist MD, Tobias GS, Wactawski-Wende J, Wareham N, Weiderpass E, Wentzensen N, Wheeler W, Yu H, Zeleniuch-Jacquotte A, Kraft P, Li D, Jacobs EJ, Petersen GM, Wolpin BM, Risch HA,Amundadottir LT, Yu K, Klein AP, Stolzenberg-Solomon RZ. Agnostic pathway/gene set analysis of genome-wide association data identifies associations for pancreatic cancer. J Natl Cancer Inst 2018:djy155. doi: 10.1093/jnci/djy155. PMCID: PMC Journal in Process.

Klein AP,* Wolpin BM,* Risch HA,* Stolzenberg-Solomon RZ,* Mocci E, Zhang M, Obazee O, Childs EJ, Hoskins JW, Jermusyk A, Zhong J, Chen F, Albanes D, Andreotti G, Arslan AA, Babic A, Bamlet WR, Beane-Freeman L, Berndt SI, Blackford A, Borges M, Borgida A, Bracci PM, Brais L, Brennan P, Brenner H, Bueno-de-Mesquita B, Buring J, Campa D, Capurso G, Cavestro GM, Chaffee KG, Chung C, Cleary S, Cotterchio M, Dijk F, Duell EJ, Foretova L, Fuchs C, Funel N, Gallinger S, Gaziano JMM, Gazouli M, Giles GG, Giovannucci E, Goggins M, Goodman GE, Goodman PJ, Hackert T, Haiman C, Hartge P, Hasan M, Hegyi P, Helzlsouer KJ, Herman J, Holcatova I, Holly EA, Hoover R, Hung RJ, Jacobs EJ, Jamroziak K, Janout V, Kaaks R, Khaw K-T, Klein EA, Kogevinas M, Kooperberg C, Kulke MH, Kupcinskas J, Kurtz RJ, Laheru D, Landi S, Lawlor RT, Lee I-M, LeMarchand L, Lu L, Malats N, Mambrini A, Mannisto S, Milne RL, Mohelníková-DuchoHová B, Neale RE, Neoptolemos JP, Oberg AL, Olson SH, Orlow I, Pasquali C, Patel AV, Peters U, Pezzilli R, Porta M, Real FX, Rothman N, Scelo G, Sesso HD, Severi G, Shu X-O, Silverman D, Smith JP, Soucek P, Sund M, Talar-Wojnarowska R, Tavano F, Thornquist MD, Tobias GS, Van Den Eeden SK, Vashist Y, Visvanathan K, Vodicka P, Wactawski-Wende J, Wang Z, Wentzensen N, White E, Yu H, Yu K, Zeleniuch-Jacquotte A, Zheng W, Kraft P, Li D, Chanock S, Canzian F, Petersen GM, Amundadottir LT. Genome-wide meta-analysis identifies five new susceptibility loci for pancreatic cancer. Nat Commun 2018;9:556. PMCID: PMC Journal in Process.

Peres LC, Risch H, Terry KL, Webb PM, Goodman MT, Wu AH, Alberg AJ, Bandera EV, Barnholtz-Sloan J, Bondy ML, Cote ML, Funkhouser E, Moorman PG, Peters ES, Schwartz AG, Terry PD, Manichaikul A, Abbott SE, Camacho F, Jordan SJ, Nagle CM, Australian Ovarian Cancer Study Group, Rossing MA, Doherty JA, Modugno F, Moysich K, Ness R, Berchuck A, Cook L, Le N, Brooks-Wilson A, Sieh W, Whittemore A, McGuire V, Rothstein J, Anton-Culver H, Ziogas A, Pearce CL, Tseng C, Pike M, Schildkraut JM, African American Cancer Epidemiology Study, Ovarian Cancer Association Consortium. Racial/ethnic differences in the epidemiology of ovarian cancer: A pooled analysis of 12 case-control studies. Int J Epidemiol 2018;47(2):460-72. PMCID: PMC Journal in Process.

Babic A, Harris HR, Vitonis AV, Titus LJ, Jordan SJ, Webb PM, Australian Ovarian Cancer Study Group, Risch HA, Rossing MA, Doherty JA, Wicklund K, Goodman MT, Modugno F, Moysich KB, Ness R, Kjaer SK, Schildkraut J, Berchuck A, Pierce CL, Wu AH, Cramer DW, Terry KL. Menstrual pain and risk of epithelial ovarian cancer: results from the Ovarian Cancer Association Consortium. Int J Cancer 2018;142(3):460-9. PMCID: PMC Journal in Process.

2017Zhou Y, Cartmel B, Gottlieb L, Ercolano EA, Li F, Harrigan M, McCorkle R, Ligibel JA, von

Gruenigen VE, Gogoi R, Schwartz PE, Risch HA, Irwin ML. Randomized trial of exercise on

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quality of life in women with ovarian cancer: Women’s Activity and Lifestyle Study in Connecticut (WALC). J Natl Cancer Inst 2017;109(12):djx072. doi: 10.1093/jnci/djx072.PMCID: PMC Journal in Process.

Streicher SA, Klein AP, Olson SH, Amundadottir LT, DeWan AT, Zhao H, Risch HA. Impact of sixteen established pancreatic cancer susceptibility loci in American Jews. Cancer Epidemiol Biomarkers Prev 2017;26(10):1540-8. PMCID: PMC Journal in Process.

Risch HA, Lu L, Streicher SA, Wang J, Zhang W, Ni Q, Kidd MS, Yu H, Gao Y-T. Aspirin use and reduced risk of pancreatic cancer. Cancer Epidemiol Biomarkers Prev 2017;26(1):68-74.PMCID: PMC5225096.

Li N, Petrick JL, Steck SE, Bradshaw PT, McClain KM, Niehoff NM, Engel LS, Shaheen NJ, Risch HA, Vaughan TL, Wu AH, Gammon MD. A pooled analysis of dietary sugar/carbohydrate intake and esophageal and gastric cardia adenocarcinoma incidence and survival in the United States (US). Int J Epidemiol 2017;46(6):1836-46. PMCID: PMC Journal in Process.

McGee J, Gianneakas V, Karlan B, Lubinski J, Gronwald J, Rosen B, McLaughlin J, Risch H, Sun P, Foulkes WD, Neuhausen S, Kotsopoulos J, Narod SA, Hereditary Ovarian Cancer Clinical Study Group. Risk of breast cancer after a diagnosis of ovarian carcinoma cancer in BRCAmutation carriers: is preventive mastectomy warranted? Gynecol Oncol 2017;145(2):346-51.*NIH funding pre-dates mandate.

Mukhtar F, Boffetta P, Risch HA, Bubu OM, Womack L, Tran TV, Zgibor JC, Luu HN. Survival predictors of Burtkitt’s Lymphoma in children, adults and elderly in the United States during 2000-2013. Int J Cancer 2017;140(7):1494-502. *Not a result of NIH funding.

Rasmussen CB, Kjaer SK, Albieri V, Bandera EV, Doherty JA, Høgdall E, Webb PM, Jordan SJ, AOCS Study Group, Rossing MA, Wicklund KG, Goodman MT, Modugno F, Moysich KB, Ness RB, Edwards RP, Schildkraut JM, Berchuck A, Olson SH, Kiemeney LA, Massuger LFAG, Narod SA, Phelan C, Anton-Culver H, Ziogas A, Wu AH, Pearce CL, Risch HA,Jensen A, on behalf of the Ovarian Cancer Association Consortium. Pelvic inflammatory disease and risk of ovarian cancer and borderline ovarian tumors: a pooled analysis of 13 case-control studies. Am J Epidemiol 2017;185(1):8-20. PMCID: PMC Journal in Process.

Buas MF, He Q, Johnson LG, Onstad L, Levine DM, Thrift AP, Gharahkhani P, Palles C, Lagergren J, Fitzgerald RC, Ye W, Caldas C, Bird NC, Shaheen NJ, Bernstein L, Gammon MD, Wu AH, Hardie LJ, Pharoah PD, Liu G, Iyer P, Corley DA, Risch HA, Chow WH, Prenen H, Chegwidden L, Love S, Attwood S, Moayyedi P, MacDonald D, Harrison R, Watson P, Barr H, deCaestecker J, Tomlinson I, Jankowski J, Whiteman DC, MacGregor S, Vaughan TL, Madeleine MM. Germline variation in inflammation-related pathways and risk of Barrett's oesophagus and oesophageal adenocarcinoma. Gut 2017;66(10):1739-47. PMCID: PMC Journal in Process.

Akbari MR, Zhang S, Cragun D, Lee JH, Coppola D, McLaughlin J, Risch HA, Rosen B, Shaw P, Sellers TA, Schildkraut J, Narod SA, Pal T. Correlation between germline mutations in MMR genes and microsatellite instability in ovarian cancer specimens. Fam Cancer 2017;16(3):351-5. PMCID: PMC Journal in Process.

Kotsopoulos J, Sopik V, Rosen B, Fan I, McLaughlin JR, Risch H, Sun P, Narod SA, Akbari MR. Frequency of germline PALB2 mutations among women with epithelial ovarian cancer. Fam Cancer 2017;16(1):29-34. PMCID: PMC Journal in Process.

Kim SJ, Rosen B, Fan I, Ivanova A, McLaughlin JR, Risch H, Narod SA, Kotsopoulos J.

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Epidemiologic factors that predict long-term survival following a diagnosis of epithelial ovarian cancer. Br J Cancer 2017;116(7):964-71. PMCID: PMC Journal in Process.

Præstegaard C, Jensen A, Jensen SM, Nielsen TSS, Webb PM, Nagle CM, DeFazio A, Australian Ovarian Cancer Study Group, Høgdall E, Rossing MA, Doherty JA, Wicklund KG, Goodman MT, Modugno F, Moysich K, Ness RB, Edwards R, Matsuo K, Hosono S, Goode EL, WinhamSJ, Fridley BL, Cramer DW, Terry KL, Schildkraut JM, Berchuck A, Bandera EV, Paddock LE, Massuger LFAG, Wentzensen N, Pharoah P, Song H, Whittemore A, McGuire V, Sieh W, Rothstein J, Anton-Culver H, Ziogas A, Menon U, Gayther SA, Ramus SJ, Gentry-Maharaj A, Wu AH, Pearce CL, Pike M, Lee AW, Sutphen R, Chang-Claude J, Risch HA, Kjaer SK, Ovarian Cancer Association Consortium. Cigarette smoking is associated with adverse survival among women with ovarian cancer: results from a pooled analysis of 19 studies. Int J Cancer 2017;140(11):2422-35. PMCID: PMC Journal in Process.

Kar SP, Adler E, Tyrer J, Hazelett D, Anton-Culver H, Bandera EV, Beckmann MW, Berchuck A, Bogdanova N, Brinton L, Butzow R, Campbell I, Carty K, Chang-Claude J, Cook LS, Cramer DW, Cunningham JM, Dansonka-Mieszkowska A, Anne Doherty JA, Dörk T, Dürst M, Eccles D, Fasching PA, Flanagan J, Gentry-Maharaj A, Glasspool R, Goode EL, Goodman MT, Gronwald J, Heitz F, Hildebrandt MAT, Høgdall E, Høgdall CK, Huntsman DG, Jensen A, Karlan BY, Kelemen LE, Kiemeney LA, Kjaer SK, Kupryjanczyk J, Lambrechts D, Levine DA, Li Q, Lissowska J, Lu KH, Lubi ski J, Massuger LFAG, McGuire V, McNeish I, Menon U, Modugno F, Monteiro AN, Moysich KB, Ness RB, Nevanlinna H, Paul J, Pearce CL, Pejovic T, Permuth JB, Phelan C, Pike MC, Poole EM, Ramus SJ, Risch HA, Rossing MA, Salvesen HB, Schildkraut JM, Sellers TA, Sherman M, Siddiqui N, Sieh W, Song H, Southey M, Terry KL, Tworoger SS, Walsh C, Wentzensen N, Whittemore AS, Wu AH, Yang H, Zheng W, Ziogas A, Freedman ML, Gayther SA, Pharoah PDP, Lawrenson K. Enrichment of putative PAX8 target genes at serous epithelial ovarian cancer susceptibility loci. Br J Cancer 2017;116(4):524-35. PMCID: PMC Journal in Process.

Lindström S, Finucane H, Bulik-Sullivan B, Schumacher F, Amos C, Hung R, Rand K, Gruber SB, Conti D, Permuth-Wey J, Lin H-Y, Sellers TA, Amundadottir L, Stolzenberg-Solomon R, Klein A, Petersen G, Risch H, Wolpin B, Peters U, GECCO Consortium, Eeles R, Easton D, Haiman CA, Hunter DJ, Neale B, Price A, Kraft P, PanScan, GECCO Consortium, CORECT Consortium, DRIVE Consortium, ELLIPSE Consortium, FOCI Consortium, TRICL Consortium. Quantifying the genetic correlation between multiple cancer types. Cancer Epidemiol Biomarkers Prev 2017;26(9):1427-35. PMCID: PMC Journal in Process.

Jordan SJ, Na R, Johnatty SE, Wise LA, Adami HO, Brinton LA, Chen C, Cook, LS, Dal Maso L, De Vivo I, Freudenheim JL, Friedenreich CM, La Vecchia C, McCann SE, Moysich KB, Lu L, Olson SH, Palmer JR, Petruzella S, Pike MC, Rebbeck TR, Ricceri F, Risch HA, Sacerdote C, Setiawan VW, Sponholtz TR, Shu XO, Spurdle AB, Weiderpass E, Wentzensen N, Yang HP, Yu H, Webb PM. Breastfeeding and endometrial cancer risk: an analysis from the Epidemiology of Endometrial Cancer Consortium. Obstet Gynecol 2017;129(6):1059-67.PMCID: PMC Journal in Process.

Telomeres Mendelian Randomization Collaboration, Haycock PC, Burgess S, Nounu A, Zheng J, Okoli GN, Bowden J, Wade KH, Timpson NJ, Evans DM, Willeit P, Aviv A, Gaunt TR, Hemani G, Mangino M, Ellis HP, Kurian KM, Pooley KA, Eeles RA, Lee JE, Fang S, Chen WV, Law MH, Bowdler LM, Iles MM, Yang Q, Worrall BB, Markus HS, Hung RJ, Amos CI, Spurdle AB, Thompson DJ, O'Mara TA, Wolpin B, Amundadottir L, Stolzenberg-Solomon R, Trichopoulou A, Onland-Moret NC, Lund E, Duell EJ, Canzian F, Severi G, Overvad K, Gunter

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MJ, Tumino R, Svenson U, van Rij A, Baas AF, Bown MJ, Samani NJ, van t'Hof FNG, Tromp G, Jones GT, Kuivaniemi H, Elmore JR, Johansson M, Mckay J, Scelo G, Carreras-Torres R, Gaborieau V, Brennan P, Bracci PM, Neale RE, Olson SH, Gallinger S, Li D, Petersen GM, Risch HA, Klein AP, Han J, Abnet CC, Freedman ND, Taylor PR, Maris JM, Aben KK, Kiemeney LA, Vermeulen SH, Wiencke JK, Walsh KM, Wrensch M, Rice T, Turnbull C, Litchfield K, Paternoster L, Standl M, Abecasis GR, SanGiovanni JP, Li Y, Mijatovic V, Sapkota Y, Low SK, Zondervan KT, Montgomery GW, Nyholt DR, van Heel DA, Hunt K, Arking DE, Ashar FN, Sotoodehnia N, Woo D, Rosand J, Comeau ME, Brown WM, Silverman EK, Hokanson JE, Cho MH, Hui J, Ferreira MA, Thompson PJ, Morrison AC, Felix JF, Smith NL, Christiano AM, Petukhova L, Betz RC, Fan X, Zhang X, Zhu C, Langefeld CD, Thompson SD, Wang F, Lin X, Schwartz DA, Fingerlin T, Rotter JI, Cotch MF, Jensen RA, Munz M, Dommisch H, Schaefer AS, Han F, Ollila HM, Hillary RP, Albagha O, Ralston SH, Zeng C, Zheng W, Shu XO, Reis A, Uebe S, Hüffmeier U, Kawamura Y, Otowa T, Sasaki T, Hibberd ML, Davila S, Xie G, Siminovitch K, Bei JX, Zeng YX, Försti A, Chen B, Landi S, Franke A, Fischer A, Ellinghaus D, Flores C, Noth I, Ma SF, Foo JN, Liu J, Kim JW, Cox DG, Delattre O, Mirabeau O, Skibola CF, Tang CS, Garcia-Barcelo M, Chang KP, Su WH, Chang YS, Martin NG, Gordon S, Wade TD, Lee C, Kubo M, Cha PC, Nakamura Y, Levy D, Kimura M, Hwang SJ, Hunt S, Spector T, Soranzo N, Manichaikul AW, Barr RG, Kahali B, Speliotes E, Yerges-Armstrong LM, Cheng CY, Jonas JB, Wong TY, Fogh I, Lin K, Powell JF, Rice K, Relton CL, Martin RM, Davey Smith G. Association between telomere length and risk of cancer and non-neoplastic diseases: a mendelian randomization study. JAMA Oncol 2017;3(5):636-51.PMCID: PMC Journal in Process.

Minlikeeva AN, Freudenheim JL, Cannioto RA, Szender JB, Eng KH, Modugno F, Ness RB, LaMonte MJ, Friel G, Segal BH, Odunsi K, Mayor P, Zsiros E, Schmalfeldt B, Klapdor R, Dçrk T, Hillemanns P, Kelemen LE, Kçbel M, Steed H, de Fazio A; Australian Ovarian Cancer Study Group, Jordan SJ, Nagle CM, Risch HA, Rossing MA, Doherty JA, Goodman MT, Edwards R, Matsuo K, Mizuno M, Karlan BY, Kjær SK, Høgdall E, Jensen A, Schildkraut JM, Terry KL, Cramer DW, Bandera EV, Paddock LE, Kiemeney LA, Massuger LF, Kupryjanczyk J, Berchuck A, Chang-Claude J, Diergaarde B, Webb PM, Moysich KB; Ovarian Cancer Association Consortium. History of hypertension, heart disease, and diabetes and ovarian cancer patient survival: evidence from the ovarian cancer association consortium. Cancer Causes Control 2017;28(5):469-86. PMCID: PMC Journal in Process.

Dixon SC, Nagle CM, Wentzensen N, Trabert B, Beeghly-Fadiel A, Schildkraut JM, Moysich KB, deFazio A; Australian Ovarian Cancer Study Group, Risch HA, Rossing MA, Doherty JA, Wicklund KG, Goodman MT, Modugno F, Ness RB, Edwards RP, Jensen A, Kjær SK, Høgdall E, Berchuck A, Cramer DW, Terry KL, Poole EM, Bandera EV, Paddock LE, Anton-Culver H, Ziogas A, Menon U, Gayther SA, Ramus SJ, Gentry-Maharaj A, Pearce CL, Wu AH, Pike MC, Webb PM. Use of common analgesic medications and ovarian cancer survival: results from a pooled analysis in the Ovarian Cancer Association Consortium. Br J Cancer 2017;116(9):1223-8. PMCID: PMC Journal in Process.

Phelan CM, Kuchenbaecker KB, Tyrer JP, Kar SP, Lawrenson K, Winham SJ, Dennis J, Pirie A, Riggan M, Chornokur G, Earp MA, Lyra PC Jr, Lee JM, Coetzee S, Beesley J, McGuffog L, Soucy P, Dicks E, Lee A, Barrowdale D, Lecarpentier J, Leslie G, Aalfs CM, Aben KKH, Adams M, Adlard J, Andrulis IL, Anton-Culver H, Antonenkova N, AOCS study group, Aravantinos G, Arnold N, Arun BK, Arver B, Azzollini J, Balmaña J, Banerjee SN, Barjhoux L, Barkardottir RB, Bean Y, Beckmann MW, Beeghly-Fadiel A, Benitez J, Bermisheva M,Bernardini M, Birrer MJ, Bisogna M, Bjorge L, Black A, Blankstein K, Blok MJ, Bodelon C,

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Bogdanova N, Bojesen A, Bonanni B, Borg Å, Bradbury AR, Brenton JD, Brewer C, Brinton L, Broberg P, Brooks-Wilson A, Bruinsma F, Brunet J, Buecher B, Butzow R, Buys SS, Caldes T, Caligo MA, Campbell I, Cannioto R, Carney ME, Cescon T, Chan SB, Chang-Claude J, Chanock S, Chen XQ, Chiew Y-E, Chiquette J, Chung WK, Claes KBM, Conner T, Cook LS, Cook J, Cramer DW, Cunningham JM, D'Aloisio AA, Daly MB, Damiola F, Damirovna SD, Dansonka-Mieszkowska A, Dao F, Davidson R, DeFazio A, Delnatte C, Doheny KF, Diez O, Ding YC, Doherty JA, Domchek SM, Dorfling CM, Dörk T, Dossus L, Duran M, Dürst M, Dworniczak B, Eccles D, Edwards T, Eeles R, Eilber U, Ejlertsen B, Ekici AB, Ellis S, Elvira M, EMBRACE Study, Eng KH, Engel C, Evans DG, Fasching PA, Ferguson S, Ferrer SF, Flanagan JM, Fogarty ZC, Fortner RT, Fostira F, Foulkes WD, Fountzilas G, Fridley BL, Friebel TM, Friedman E, Frost D, Ganz PA, Garber J, García MJ, Garcia-Barberan V, Gehrig A, GEMO Study Collaborators, Gentry-Maharaj A, Gerdes A-M, Giles GG, Glasspool R, Glendon G, Godwin AK, Goldgar DE, Goranova T, Gore M, Greene MH, Gronwald J, Gruber S, Hahnen E, Haiman CA, Håkansson N, Hamann U, Hansen TVO, Harrington PA, Harris HR, Hauke J, HEBON Study, Hein A, Henderson A, Hildebrandt MAT, Hillemanns P, Hodgson S, Høgdall CK, Høgdall E, Hogervorst FBL, Holland H, Hooning MJ, Hosking K, Huang R-Y, Hulick PJ, Hung J, Hunter DJ, Huntsman DG, Huzarski T, Imyanitov EN, Isaacs C, Iversen ES, Izatt L, Izquierdo A, Jakubowska A, James P, Janavicius R, Jernetz M, Jensen A, Jensen UB, John EM, Johnatty S, Jones ME, Kannisto P, Karlan BY, Karzenis A, Kast K, KConFab Investigators, Kennedy CJ, Khusnutdinova E, Kiemeney LA, Kiiski JI, Kim S-W, Kjaer SK, Köbel M, Kopperud RK, Kruse TA, Kupryjanczyk J, Kwong A, Laitman Y, Lambrechts D, Larrañaga N, Larson MC, Lazaro C, Le ND, Marchand LL, Lee JW, Lele SB, Leminen A, Leroux D, Lester J, Lesueur F, Levine DA, Liang D, Liebrich C, Lilyquist J, Lipworth L, Lissowska J, Lu KH, Lubi ski J, Luccarini C, Lundvall L, Mai PL, Mendoza-Fandiño G, Manoukian S, Massuger LFAG, May T, Mazoyer S, McAlpine J, McGuire V, McLaughlin JR, McNeish I, Meijers-Heijboer HEJ, Meindl A, Menon U, Mensenkamp AR, Merritt M, Milne RL, Mitchell G, Modugno F, Moes-Sosnowska J, Moffitt M, Montagna M, Moysich KB, Mulligan AM, Musinsky J, Nathanson KL, Nedergaard L, Ness RB, Neuhausen SL, Nevanlinna H, Niederacher D, Nussbaum RL, Odunsi K, Olah E, Olopade OI, Olsson H, Olswold C, O'Malley DM, Ong K-r, Onland-Moret NC, OPAL study group, Orr N, Orsulic S, Osorio A, Palli D, Papi L, Park-Simon T-W, Paul J, Pearce CL, Pedersen IS, Peeters PHM, Peissel B, Peixoto A, Pejovic T, Pelttari LM, Permuth JB, Peterlongo P, Pezzani L, Pfeiler G, Phillips K-A, Piedmonte M, Pike MC, Piskorz AM, Poblete SR, Pocza T, Poole EM, Poppe B, Porteous ME, Prieur F, Prokofyeva D, Pugh E, Pujana MA, Pujol P, Radice P, Rantala J, Rappaport-Fuerhauser C, Rennert G, Rhiem K, Rice P, Richardson A, Robson M, Rodriguez GC, Rodríguez-Antona C, Romm J, Rookus MA, Rossing MA, Rothstein JH, Rudolph A, Runnebaum IB, Salvesen HB, Sandler DP, Schoemaker MJ, Senter L, Setiawan VW, Severi G, Sharma P, Shelford T, Siddiqui N, Side LE, Sieh W, Singer CF, Sobol H, Song H, Southey MC, Spurdle AB, Stadler Z, Steinemann D, Stoppa-Lyonnet D, Sucheston-Campbell LE, Sukiennicki G, Sutphen R, Sutter C, Swerdlow AJ, Szabo CI, Szafron L, Tan YY, Taylor JA, Tea M-K, Teixeira MR, Teo S-H, Terry KL, Thompson PJ, Thomsen LCV, Thull DL, Tihomirova L, Tinker AV, Tischkowitz M, Tognazzo S, Toland AE, Tone A, Trabert B, Travis R, Trichopoulou A, Tung N, Tworoger SS, van Altena AM, Van Den Berg D, van der Hout AH, van der Luijt RB, Van Heetvelde M, Van Nieuwenhuysen E, van Rensburg EJ, Vanderstichele A, Varon-Mateeva R, Vega A, Edwards DV, Vergote I, Vierkant RA, Vijai J, Vratimos A, Walker L, Walsh C, Wand D, Wang-Gohrke S, Wappenschmidt B, Webb PM, Weinberg CR, Weitzel JN, Wentzensen N, Whittemore AS, Wijnen JT, Wilkens LR, Wolk A, Woo M, Wu X, Wu AH, Yang H, Yannoukakos D, Ziogas A, Zorn KK, Narod SA, Easton DF,

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Amos CI, Schildkraut JM, Ramus SJ, Ottini L, Goodman MT, Park SK, Kelemen LE, Risch HA, Thomassen M, Offit K, Simard J, Schmutzler RK, Hazelett D, Monteiro AN, Couch FJ, Berchuck A, Chenevix-Trench G, Goode EL, Sellers TA, Gayther SA, Antoniou AC, Pharoah PDP. Identification of 12 new susceptibility loci for different histotypes of epithelial ovarian cancer. Nat Genet 2017;49(5):680-91. PMCID: PMC Journal in Process.

Minlikeeva AN, Freudenheim JL, Eng KH, Cannioto RA, Friel G, Szender JB, Segal B, Odunsi K, Mayor P, Diergaarde B, Zsiros E, Kelemen L, Köbel M, Steed H, de Fazio A, Australian Ovarian Cancer Study Group, Jordan S, Fasching PA, Beckmann MW, Risch HA, Rossing MA, Doherty JA, Chang-Claude J, Goodman MT, Dçrk T, Edwards R, Modugno F, Ness RB, Matsuo K, Mizuno M, Karlan BY, Goode EL, Kjær SK, Høgdall E, Schildkraut JM, Terry KL, Cramer DW, Bandera EV, Paddock L, KiemeneyLA, Massuger LF, Sutphen R, Anton-Culver H, Ziogas A, Menon U, Gayther S, Ramus S, Gentry-Maharaj A, Pearce CL, Kupryjanczyk J, Jensen A, Webb PM, Moysich KB, Ovarian Cancer Association Consortium. History of comorbidities and survival of ovarian cancer patients, results from the Ovarian Cancer Association Consortium. Cancer Epidemiol Biomarkers Prev 2017;26(9):1470-3. PMCID: PMC Journal in Process.

2016Chen MM, O'Mara TA, Thompson DJ, Painter JN, Australian National Endometrial Cancer Study

Group (ANECS), Attia J, Black A, Brinton L, Chanock S, Chen C, Chen C, Cheng THT, Cook LS, Crous-Bou M, Doherty J, Friedenreich CM, Garcia-Closas M, Gaudet MM, Gorman M, Haiman C, Hankison SE, Hartge P, Henderson BE, Hodgson S, Holliday EG, Horn-Ross PL, Hunter DJ, Le Marchand L, Liang X, Lissowska J, Long J, Lu L, Magliocco AM, Martin L, McEvoy M, National Study of Endometrial Cancer Genetics Group (NSECG), Olson SH, Orlow I, Pooler L, Prescott J, Rastogi R, Rebbeck TR, Risch H, Sacerdote C, Schumacher F, Setiawan VW, Scott RJ, Sheng X, Shu X-O, VanDen Berg D, Weiss NS, Wentzensen N, Xia L, Xiang Y-B, Yang HP, Yu H, Zhang W, Pharoah PDP, Dunning AM, Tomlinson I, Easton DF, Kraft P, Spurdle AB, De Vivo I. GWAS meta-analysis of 16,852 women identifies new susceptibility locus for endometrial cancer. Hum Mol Genet 2016;25(12):2612-20. PMCID: PMC5868213.

Fu Y, Biglia N, Wang Z, Shen Y, Risch HA, Lu L, Canuto EM, Jia W, Katsaros D, Yu H. Long non-coding RNAs, ASAP1-IT1, FAM215A, and LINC00472, in epithelial ovarian cancer. Gyn Oncol 2016;143(3):642-9. *Not a result of NIH funding.

Schulte A, Pandeya N, Fawcett J, Fritschi L, Klein K, Risch HA, Webb PM, Whiteman DC, Neale RE. Association between family cancer history and risk of pancreatic cancer. Cancer Epidemiol 2016;45:145-50. *Not a result of NIH funding.

Lu L, Risch, HA. Exosomes: potential for early detection in pancreatic cancer. Future Oncol 2016;12(8):1081-90. *Not a result of NIH funding.

Lu L, Katsaros D, Canuto EM, Biglia N, Risch HA, Yu H. LIN-28B/let-7a/IGF-II axis molecular subtypes are associated with epithelial ovarian cancer prognosis. Gynecol Oncol 2016;141(1):121-7. *Not a result of NIH funding.

Wei R, De Vivo I, Huang S, Risch H, Moore JH, Yu H, Garmire LX. Meta-dimensional data integration identifies critical pathways for susceptibility, tumorigenesis and progression of endometrial cancer. Oncotarget 2016;7(34):55249-63. PMCID: PMC5342415.

Clyde MA, Palmieri Weber RP, Iversen ES, Poole EM, Doherty JA, Goodman MT, Ness RB, Risch HA, Rossing MA, Terry KL, Wentzensen N, Whittemore AS, Anton-Culver H, Bandera

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EV, Berchuck A, Carney ME, Cramer DW, Cunningham JM, Cushing-Haugen KL, Edwards RP, Fridley BL, Goode EL, Lurie G, McGuire V, Modugno F, Moysich KB, Olson SH, Pearce CL, Pike MC, Rothstein JH, Sellers TA, Sieh W, Stram D, Thompson PJ, Vierkant RA, Wicklund KG, Wu AH, Ziogas A, Tworoger SS, Schildkraut JM, Ovarian Cancer Association Consortium. Risk prediction for epithelial ovarian cancer in eleven United States-based case-control studies: incorporation of epidemiologic risk factors and 17 confirmed genetic loci. Am J Epidemiol 2016;184(8):579-89. PMCID: PMC5065620.

Karami S, Han Y, Pande M, Cheng I, Rudd J, Pierce BL, Nutter EL, Schumacher FR, Kote-Jarai Z, Lindstrom S, Witte JS, Fang S, Han J, Kraft P, Hunter D, Song F, Hung RJ, McKay J, Gruber SB, Chanock SJ, Risch A, Shen H, Haiman CA, Boardman L, Ulrich CM, Casey G, Peters U, Al Olama AA, Berchuck A, Berndt SI, Bezieau S, Brennan P, Brenner H, Brinton L, Caporaso N, Chan AT, Chang-Claude J, Christiani DC, Cunningham JM, Easton D, Eeles RA, Eisen T, Gala M, Gallinger SJ, Gayther SA, Goode EL, Grönberg H, Henderson BE, Houlston R, Joshi AD, Küry S, Landi MT, Le Marchand L, Muir K, Newcomb PA, Permuth-Wey J, Pharoah P, Phelan C, Potter JD, Ramus SJ, Risch H, Schildkraut J, Slattery ML, Song H, Wentzensen N, White E, Wiklund F, Zanke BW, Sellers TA, Zheng W, Chatterjee N, Amos CI, Doherty JA, GECCO and the GAME-ON Network: CORECT, DRIVE, ELLIPSE, FOCI, and TRICL. Telomere structure and maintenance gene variants and risk of five cancer types. Int J Cancer 2016;139(12):2655-70. PMCID: PMC5198774.

Machiela MJ, Zhou W, Karlins E, Sampson JN, Freedman ND, Yang Q, Hicks B, Dagnall C, Hautman C, Jacobs KB, Abnet CC, Aldrich MC, Amos C, Amundadottir LT, Berndt SI, Black A, Blot WJ, Bock CH, Bracci PM, Brinton LA, Burdett L, Buring JE, Butler MA, Carreón T, Chang I-S, Chatterjee N, Chen C, Chen C, Chen K, Chung CC, Cook LS, Bou MC, Cullen M, Davis FG, De Vivo I, Ding T, Doherty J, Duell EJ, Epstein CG, Fan J-H, Figueroa JD, Fraumeni JF Jr, Friedenreich CM, Fuchs CS, Gao Y-T, Gapstur SM, Garcia-Closas M, Gaudet MM, Gaziano JM, Giles GG, Gillanders EM, Giovannucci EL, Goldin L, Goldstein AM, Haiman CA, Hallmans G, Hankinson SE, Harris CC, Henriksson R, Holly EA, Hong Y-C, Hoover RN, Hsiung CA, Hu N, Hu W, Hunter DJ, Hutchinson A, Jenab M, Johansen C, Khaw K-T, Kim HN, Kim YH, Kim YT, Klein R, Koh W-P, Kolonel LN, Kooperberg C, Kraft P, Krogh V, Kurtz RC, LaCroix A, Lan Q, Landgren A, Landi MT, Le Marchand L, Li D, Liang X, Liao LM, Lin D, Liu J, Lissowska J, Lu L, Magliocco AM, Malats N, Matsuo K, McNeill LH, McWilliams RR, Melin BS, Mirabello L, Moore L, Olson SH, Orlow I, Park JY, Patiño-Garcia A, Peplonska B, Peters U, Petersen GM, Pooler L, Prescott J, Prokunina-Olsson L, Purdue M, Qiao Y-L, Rabe KG, Rajaraman P, Real FX, Riboli E, Risch HA, Rodriguez-Santiago B, Ruder AM, Savage SA, Schumacher F, Schwartz AG, Schwartz KL, Seow A, Sesso HD, Setiawan VW, Severi G, Shen H, Sheng X, Shin M-H, Shu X-O, Silverman DT, Spitz MR, Stevens VL, Stolzenberg-Solomon R, Stram D, Tang Z-Z, Taylor PR, Teras LR, Tobias GS, VanDen Berg D, Viswanathan K, Wacholder S, Wang J-C, Wang Z, Wentzensen N, Wheeler W, White E, Wiencke JK, Wolpin BM, Wong MP, Wu C, Wu T, Wu X, Wu Y-L, Wunder JS, Xia L, Yang HP, Yang P-C, Yu K, Zanetti KA, Zeleniuch-Jacquotte A, Zheng W, Zhou B, Ziegler RG, Perez-Jurado LA, Caporaso NE, Rothman N, Tucker M, Dean MC, Yeager M, Chanock SJ. Female chromosome X mosaicism is age-related and preferentially affects the inactivated X chromosome. Nat Commun 2016;7:11843. PMCID: PMC4909985.

Lawrenson K, Kar S, McCue K, Kuchenbaeker K, Michailidou K, Tyrer J, Beesley J, Ramus SJ, Li Q, Delgado MK, Lee J, Aittomäki K, Andrulis IL, Anton-Culver H, Arndt V, Arun BK, Arver B, Bandera EV, Barile M, Barkardottir RB, Barrowdale D, Beckmann MW, Benitez J, Berchuck A, Bisogna M, Bjorge L, Blomqvist C, Blot W, Bogdanova N, Bojesen A, Bojesen

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SE, Bolla MK, Bonanni B, Borresen-Dale A-L, Brauch H, Brennan P, Brenner H, Bruinsma F, Brunet J, Buhari SA, Burwinkel B, Butzow R, Buys SS, Cai Q, Caldes T, Campbell I, Canniotto R, Chang-Claude J, Chiquette J, Choi J-Y, Claes KBM, GEMO Study Collaborators, Cook LS, Cox A, Cramer DW, Cross SS, Cybulski C, Czene K, Daly MB, Damiola F, Dansonka-Mieszkowska A, Darabi H, Dennis J, Devilee P, Diez O, Doherty JA, Domchek SM, Dorfling CM, Dörk T, Dumont M, Ehrencrona H, Ejlertsen B, Ellis S, EMBRACE, Engel C, Eunjung L, Evans DG, Fasching PA, Feliubadalo L, Figueroa J, Flesch-Janys D, Fletcher O, Flyger H, Foretova L, Fostira F, Foulkes WD, Fridley BL, Friedman E, Frost D, Gambino G, Ganz PA, Garber J, García-Closas M, Gentry-Maharaj A, Ghoussaini M, Giles GG, Glasspool R, Godwin AK, Goldberg MS, Goldgar DE, González-Neira A, Goode EL, Goodman MT, Greene MH, Gronwald J, Guénel P, Haiman CA, Hall P, Hallberg E, Hamann U, Hansen TVO, Harrington PA, Hartman M, Hassan N, Healey S, HEBON, Heitz F, Herzog J, Høgdall E, Høgdall CK, Hogervorst FBL, Hollestelle A, Hopper JL, Hulick PJ, Huzarski T, Imyanitov EN, KConFab Investigators, Australian Ovarian Cancer Study Group, Isaacs C, Ito H, Jakubowska A, Janavicius R, Jensen A, John EM, Johnson N, Kabisch M, Kang D, Kapuscinski M, Karlan BY, Khan S, Kiemeney LA, Kjaer SK, Knight JA, Konstantopoulou I, Kosma V-M, Kristensen V, Kupryjanczyk J, Kwong A, de la Hoya M, Laitman Y, Lambrechts D, Le N, De Leeneer K, Lester J, Levine DA, Li J, Lindblom A, Long J, Lophatananon A, Loud JT, Lu K, Lubinski J, Mannermaa A, Manoukian S, Le Marchand L, Margolin S, Marme F, Massuger LFAG, Matsuo K, Mazoyer S, McGuffog L, McLean C, McNeish I, Meindl A, Menon U, Mensenkamp AR, Milne RL, Montagna M, Moysich KB, Muir K, Mulligan AM, Nathanson KL, Ness RB, Neuhausen SL, Nevanlinna H, Nord S, Nussbaum RL, Odunsi K, Offit K, Olah E, Olopade OI, Olson JE, Olswold C, O’Malley D, Orlow I, Orr N, Osorio A, Park SK, Pearce CL, Pejovic T, Peterlongo P, Pfeiler G, Phelan CM, Poole EM, Pylkäs K, Radice P, Rantala J, Rashid MU, Rennert G, Rhenius V, Rhiem K, Risch HA, Rodriguez G, Rossing MA, Rudolph A, Salvesen HB, Sangrajrang S, Sawyer EJ, Schildkraut JM, Schmidt MK, Schmutzler RK, Sellers TA, Seynaeve C, Shah M, Shen C-Y, Shu X-O, Sieh W, Singer CF, Sinilnikova OM, Slager S, Song H, Soucy P, Southey MC, Stenmark-Askmalm M, Stoppa-Lyonnet D, Sutter C, Swerdlow A, Tchatchou S, Teixeira MR, Teo SH, Terry KL, Terry MB, Thomassen M, Tibiletti MG, Tihomirova L, Tognazzo S, Toland AE, Tomlinson I, Torres D, Truong T, Tseng C-C, Tung N, Tworoger SS, Vachon C, van den Ouweland AMW, van Doorn HC, van Rensburg EJ, Van't Veer LJ, Vanderstichele A, Vergote I, Vijai J, Wang Q, Wang-Gohrke S, Weitzel JN, Wentzensen N, Whittemore AS, Wildiers H, Winqvist R, Wu AH, Yannoukakos D, Yoon S-Y, Yu J-C, Zheng W, Zheng Y, Khanna KK, Simard J, Monteiro AN, French JD, Couch FJ, Freedman ML, Easton DF, Dunning AM, Pharoah PDP, Edwards SL, Chenevix-Trench G, Antoniou AC, Gayther SA. Functional mechanisms underlying pleiotropic risk alleles at the 19p13.1 breast-ovarian cancer susceptibility locus. Nat Commun 2016;7:12675. PMCID: PMC5023955.

Dixon SC, Nagle CM, Thrift AP, Pharoah PDP, Pearce CL, Zheng W, Painter JN, AOCS Group, Australian Cancer Study (Ovarian Cancer), Chenevix-Trench G, Fasching PA, Beckmann MW, Lambrechts D, Vergote I, Lambrechts S, Van Nieuwenhuysen E, Rossing MA, Doherty JA, Wicklund KG, Chang-Claude J, Rudolph A, Moysich KB, Odunsi K, Goodman MT, Wilkens LR, Thompson PJ, Shvetsov YB, Dörk T, Park-Simon T-W, Hillemanns P, Bogdanova N, Butzow R, Nevanlinna H, Pelttari LM, Leminen A, Modugno F, Ness RB, Edwards RP, Kelley JL, Heitz F, Karlan BY, Kjær SK, Høgdall E, Jensen A, Goode EL, Fridley BL, Cunningham JM, Winham SJ, Giles GG, Bruinsma F, Milne RL, Southey MC, Hildebrandt MAT, Wu X, Lu KH, Liang D, Levine DA, Bisogna M, Schildkraut JM, Berchuck A, Cramer DW, Terry KL,

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Bandera EV, Olson SH, Salvesen HB, Thomsen LC, Kopperud RK, Bjorge L, Kiemeney LA, Massuger LFAG, Pejovic T, Cook LS, Le ND, Swenerton KD, Brooks-Wilson A, Kelemen LE, Lubi ski J, Huzarski T, Gronwald J, Menkiszak J, Wentzensen N, Brinton L, Yang H, Lissowska J, Høgdall CK, Lundvall L, Song H, Tyrer JP, Campbell I, Eccles D, Paul J, Glasspool R, Siddiqui N, Whittemore AS, Sieh W, McGuire V, Rothstein JH, Narod SA, Phelan C, Risch HA, McLaughlin JR, Anton-Culver H, Ziogas A, Menon U, Gayther SA, Ramus SJ, Gentry-Maharaj A, Wu AH, Pike MC, Tseng C-C, Kupryjanczyk J, Dansonka-Mieszkowska A, Budzilowska A, Spiewankiewicz B, Webb PM, Ovarian Cancer Association Consortium. Adult body mass index and risk of ovarian cancer by subtype: a Mendelian randomization study. Int J Epidemiol 2016;45(3): 884-95. PMCID: PMC5644573.

Permuth JB, Reid B, Earp M, Chen YA, Monteiro ANA, Chen Z, AOCS Study Group, Chenevix-Trench G, Fasching PA, Beckmann MW, Lambrechts D, Vanderstichele A, Van Niewenhuyse E, Vergote I, Rossing MA, Doherty JA, Chang-Claude J, Moysich K, Odunsi K, Goodman MT, Shvetsov YB, Wilkens LR, Thompson PJ, Dörk T, Bogdanova N, Butzow R, Nevanlinna H, Pelttari L, Leminen A, Modugno F, Edwards RP, Ness RB, Kelley J, Heitz F, Karlan B, Lester J, Kjaer SK, Jensen A, Giles G, Neumann S, Hildebrandt M, Liang D, Lu KH, Wu X, Levine DA, Bisogna M, Berchuck A, Cramer DW, Terry KL, Tworoger SS, Poole EM, Bandera EV, Fridley B, Cunningham J, Winham SJ, Olson SH, Orlow I, Bjorge L, Kiemeney LA, Massuger L, Pejovic T, Moffitt M, Le N, Cook LS, Brooks-Wilson A, Kelemen LE, Gronwald J, Lubinski J, Wentzensen N, Brinton LA, Lissowska J, Yang H, Hogdall E, Hogdall C, Lundvall L, Pharoah PDP, Song H, Campbell I, Eccles D, McNeish I, Whittemore A, McGuire V, Sieh W, Rothstein J, Phelan CM, Risch H, Narod S, McLaughlin J, Anton-Culver H, Ziogas A, Menon U, Gayther S, Ramus SJ, Gentry-Maharaj A, Pearce CL, Wu AH, Kupryjanczyk J, Dansonka-Mieszkowska A, Schildkraut JM, Cheng JQ, Goode EL, Sellers TA, Ovarian Cancer Association Consortium. Inherited variants affecting RNA editing may contribute to ovarian cancer susceptibility: results from a large-scale collaboration. Oncotarget 2016;7(45): 72381-94. PMCID: PMC5340123.

Hampras SS, Sucheston-Campbell LE, Cannioto R, Chang-Claude J, Modugno F, Dörk T, Hillemanns P, Preus L, Knutson KL, K.Wallace P, Hong C-C, Friel G, Davis W, Nesline M, Pearce CL, Kelemen LE, Goodman MT, Bandera EV, Terry KL, Schoof N, Eng KH, Clay A, Singh PK, Joseph JM, Aben KKH, Anton-Culver H, Antonenkova N, Baker H, Bean Y, Beckmann MW, Bisogna M, Bjorge L, Bogdanova N, Brinton LA, Brooks-Wilson A, Bruinsma F, Butzow R, Campbell IG, Carty K, Cook LS, Cramer DW, Cybulski C, Dansonka-Mieszkowska A, Dennis J, Despierre E, Dicks E, Doherty JA, du Bois A, Dürst M, Easton D, Eccles D, Edwards RP, Ekici AB, Fasching PA, Fridley BL, Gao Y-T, Gentry-Maharaj A, Giles GG, Glasspool R, Gronwald J, Harrington P, Harter P, Hasmad HN, Hein A, Heitz F, Hildebrandt MAT, Hogdall C, Hogdall E, Hosono S, Iversen ES, Jakubowska A, Jensen A, Ji B-T, Karlan BY, Kellar M, Kelley JL, Kiemeney LA, Klapdor R, Kolomeyevskaya N, Krakstad C, Kjaer SK, Kruszka B, Kupryjanczyk J, Lambrechts D, Lambrechts S, Le ND, Lee AW, Lele S, Leminen A, Lester J, Levine DA, Liang D, Lissowska J, Liu S, Lu K, Lubinski J, Lundvall L, Massuger LFAG, Matsuo K, McGuire V, McLaughlin JR, McNeish I, Menon U, Moes-Sosnowska J, Narod SA, Nedergaard L, Nevanlinna H, Nickels S, Olson SH, Orlow I, Weber RP, Paul J, Pejovic T, Pelttari LM, Perkins B, Permuth-Wey J, Pike MC, Plisiecka-Halasa J, Poole EM, Risch HA, Rossing MA, Rothstein JH, Rudolph A, Runnebaum IB, Rzepecka IK, Salvesen HB, Schernhammer E, Schmitt K, Schwaab I, Shu X-O, Shvetsov YB, Siddiqui N, Sieh W, Song H, Southey MC, Tangen IL, Teo S-H, Thompson PJ, Timorek A, Tsai Y-Y, Tworoger SS, Tyrer J, van Altena AM, Vergote I, Vierkant RA, Walsh C, Wang-Gohrke S,

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Wentzensen N, Whittemore AS, Wicklund KG, Wilkens LR, Wu AH, Wu X, Woo Y-L, Yang H, Zheng W, Ziogas A, Gayther SA, Ramus SJ, Sellers TA, Schildkraut JM, Phelan CM, Berchuck A, Chenevix-Trench on behalf of the Australian Ovarian Cancer Study Group G, Cunningham JM, Pharoah PDP, Ness RB, Odunsi K, Goode EL, Moysich KB. Assessment of variation in immunosuppressive pathway genes reveals TGFBR2 to be associated with risk of clear cell ovarian cancer. Oncotarget 2016;7(43):69097-110. PMCID: PMC5340115.

Zhang M, Wang Z, Obazee O, Jia J, Childs E, Hoskins J, Figlioli G, Mocci E, Collins I, Chung CC, Hautman C, Arslan AA, Beane-Freeman L, Bracci PM, Buring J, Duell EJ, Gallinger S, Giles GG, Goodman GE, Goodman PJ, Kamineni A, Kolonel LN, Kulke MH, Malats N, Olson SH, Sesso HD, Visvanathan K, White E, Zheng W, Abnet CC, Albanes D, Andreotti G, Austin MA, Bueno-de-Mesquita HB, Basso D, Berndt SI, Boutron-Ruault M-C, Bijlsma M, Brenner H, Burdette L, Campa D, Caporaso NE, Capurso G, Cavestro GM, Cotterchio M, Costello E, Elena J, Boggi U, Gaziano JM, Gazouli M, Giovannucci EL, Goggins M, Gorman MJ, Gross M, Haiman CA, Hassan M, Helzlsouer KJ, Hu N, Hunter DJ, Iskierka-Jazdzewska E, Jenab M, Kaaks R, Key TJ, Khaw K-T, Klein EA, Kogevinas M, Krogh V, Kupcinskas J, Kurtz RC, Landi MT, Landi S, Le Marchand L, Mambrini A, Mannisto S, Milne RL, Neale R, Oberg AL, Panico S, Patel AV, Peeters PHM, Peters U, Pezzilli R, Tavano F, Porta M, Purdue M, Quiros JR, Riboli E, Rothman N, Scarpa A, Scelo G, Shu X-O, Silverman DT, Soucek P, Strobel O, Sund M, Małecka-Panas E, Taylor PR, Travis RC, Thornquist M, Tjønneland A, Tobias GS, Trichopoulos D, Vashist Y, Vodicka P, Wactawski-Wende J, Wentzensen N, Yu H, Yu K, Zeleniuch-Jacquotte A, Kooperberg C, Risch HA, Jacobs EJ, Li D, Fuchs C, Hoover R, Hartge P, Chanock SJ, Petersen GM, Stolzenberg-Solomon RS, Wolpin BM, Kraft P, Klein AP, Canzian F, Amundadottir LT. Three new pancreatic cancer susceptibility signals identified on chromosomes 1q32.1, 5p15.33 and 8q24.21. Oncotarget 2016;7(41):66328-43. PMCID: PMC5340084.

Cannioto R, LaMonte MJ, Risch HA, Hong C-C, Sucheston-Campbell LE, Eng KH, Szender JB, Chang-Claude J, Schmalfeldt B, Klapdor R, Gower E, Minlikeeva AN, Zirpoli G, Bandera EV, Berchuck A, Cramer D, DohertyJA, Edwards RP, Fridley BL, Goode EL, Goodman MT, Hogdall E, Hosono S, Jensen A, Jordan S on behalf of The Australian Ovarian Cancer Study Group, Kjaer SK, Matsuo K, Ness RB, Olsen CM, Olson SH, Pearce CL, Pike MC, Rossing MA, Szamreta EA, Thompson PJ, Tseng C-C, Vierkant RA, Webb PM, Wentzensen N, Wicklund KG, Winham SJ, Wu AH, Modugno F, Schildkraut JM, Terry KL, Kelemen LE, Moysich KB. Chronic recreational physical inactivity and epithelial ovarian cancer risk: Evidence from the Ovarian Cancer Association Consortium. Cancer Epidemiol Biomarkers Prev 2016;25(7): 1114-24. PMCID: PMC4930728.

Cannioto RA, LaMonte MJ, Kelemen LE, Risch HA, Eng KH, Minlikeeva AN, Hong C-C, Szender JB, Sucheston-Campbell L, Joseph JM, Berchuck A, Chang-Claude J, Cramer DW, DeFazio A on behalf of The Australian Ovarian Cancer Study Group, Diergaarde B, Dörk T, Doherty JA, Edwards RP, Fridley BL, Friel G, Goode EL, Goodman MT, Hillemanns P, Hogdall E, Hosono S, Kelley JL, Kjaer SK, Klapdor R, Matsuo K, Odunsi K, Nagle CM, Olsen CM, Paddock LE, Pearce CL, Pike MC, Rossing MA, Schmalfeldt B, Segal B, Szamreta EA,Thompson PJ, Tseng C-C, Vierkant R, Schildkraut JM, Wentzensen N, Wicklund KG, Winham SJ, Wu AH, Modugno F, Ness RB, Jensen A, Webb PM, Terry K, Bandera EV, Moysich KB. Recreational physical inactivity and mortality in women with invasive epithelial ovarian cancer: Evidence from the Ovarian Cancer Association Consortium. Br J Cancer 2016;115(1): 95-101. PMCID: PMC4931371.

Ong J-S, Cuellar-Partida G, Lu Y, Australian Ovarian Cancer Study, Fasching PA, Hein A,

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Burghaus S, Beckmann MW, Lambrechts D, Van Nieuwenhuysen E, Vergote I, Vanderstichele A, Doherty JA, Rossing MA, Chang-Claude J, Eilber U, Rudolph A, Wang-Gohrke S, Goodman MT, Bogdanova N, Dörk T, Dürst M, Hillemanns P, Runnebaum IB, Antonenkova N, Butzow R, Leminen A, Nevanlinna H, Pelttari LM, Edwards RP, Kelley JL, Modugno- F, Moysich KB, Ness RB, Cannioto R, Høgdall E, Høgdall CK, Jensen A, Giles- GG, Bruinsma F, Kjaer SK, Hildebrandt MAT, Liang D, Lu KH, Wu X, Bisogna M, Dao F, Levine DA, Cramer DW, Terry KL, Tworoger SS, Stampfer M, Missmer S, Bjorge L, Salvesen HB, Kopperud RK, Bischof K, Aben KKH, Kiemeney LA, Massuger LFAG, Brooks-Wilson A, Olson SH, McGuire V, Rothstein JH, Sieh W, Whittemore AS, Cook LS, Le ND, Gilks CB, Gronwald J, Jakubowska A, Lubi ski J, Kluz T, Song H, Tyrer JP, Wentzensen N, Brinton L, Trabert B, Lissowska J, McLaughlin JR, Narod SA, Phelan C, Anton-Culver H, Ziogas A, Eccles D, Campbell I, Gayther SA, Gentry-Maharaj A, Menon U, Ramus SJ, Wu AH, Dansonka-Mieszkowska A, Kupryjanczyk J, Timorek A, Szafron L, Cunningham JM, Fridley BL, Winham SJ, Bandera EV, Poole EM, Morgan TK, Risch HA, Goode EL, Schildkraut JM, Pearce CL, Berchuck A, Pharoah PDP, Chenevix-Trench G, Gharahkhani P, Neale RE, Webb PM, MacGregor S. Association of vitamin D levels and risk of ovarian cancer: a Mendelian randomization study. Int J Epidemiol 2016;45(5):1619-30. PMCID: PMC5100621.

Hollestelle A, van der Baan FH, Berchuck A, Johnatty SE, Aben KK, Agnarsson BA, Aittomäki K, Alducci E, Andrulis IL, Anton-Culver H, Antonenkova NN, Antoniou AC, Apicella C, Arndt V, Arnold N, Arun BK, Arver B, Ashworth A, Australian Ovarian Cancer Study Group, Baglietto L, Balleine R, Bandera EV, Barrowdale D, Bean YT, Beckmann L, Beckmann MW, Benitez J, Berger A, Berger R, Beuselinck B, Bisogna M, Bjorge L, Blomqvist C, Bogdanova NV, Bojesen A, Bojesen SE, Bolla MK, Bonanni B, Brand JS, Brauch H, Breast Cancer Family Register, Brenner H, Brinton L, Brooks-Wilson A, Bruinsma F, Brunet J, Brüning T, Budzilowska A, Bunker CH, Burwinkel B, Butzow R, Buys SS, Caligo MA, Campbell I, Carter J, Chang-Claude J, Chanock SJ, Claes KBM, Collée JM, Cook LS, Couch FJ, Cox A, Cramer D, Cross SS, Cunningham JM, Cybulski C, Czene K, Damiola F, Dansonka-Mieszkowska A, Darabi H, de la Hoya M, de Fazio A, Dennis J, Devilee P, Dicks EM, Diez O, Doherty JA, Domchek SM, Dorfling CM, Dörk T, Dos Santos Silva I, du Bois A, Dumont M, Dunning AM, Duran M, Easton DF, Eccles D, Edwards RP, Ehrencrona H, Ejlertsen B, Ekici AB, Ellis SD, EMBRACE, Engel C, Eriksson M, Fasching PA, Feliubadalo L, Figueroa J, Flesch-Janys D, Fletcher O, Fontaine A, Fortuzzi S, Fostira F, Fridley BL, Friebel T, Friedman E, Friel G, Frost D, Garber J, García-Closas M, Gayther SA, GEMO Study Collaborators, GENICA Network, Gentry-Maharaj A, Gerdes A-M, Giles GG, Glasspool R, Glendon G, Godwin AK, Goodman MT, Gore M, Greene MH, Grip M, Gronwald J, Gschwantler Kaulich D, Guénel P, Guzman SR, Haeberle L, Haiman CA, Hall P, Halverson SL, Hamann U, Hansen TVO, Harter P, Hartikainen JM, Healey S, HEBON, Hein A, Heitz F, Henderson BE, Herzog J, Hildebrandt MAT, Høgdall CK, Høgdall E, Hogervorst FBL, Hopper JL, Humphreys K, Huzarski T, Imyanitov EN, Isaacs C, Jakubowska A, Janavicius R, Jaworska K, Jensen A, Jensen UB, Johnson N, Jukkola-Vuorinen A, Kabisch M, Karlan BY, Kataja V, Kauff N, KConFab Investigators, Kelemen LE, Kerin MJ, Kiemeney LA, Kjaer SK, Knight JA, Knol-Bout JP, Konstantopoulou I, Kosma V-M, Krakstad C, Kristensen V, Kuchenbaecker KB, Kupryjanczyk J, Laitman Y, Lambrechts D, Lambrechts S, Larson MC, Lasa A, Laurent-Puig P, Lazaro C, Le ND, Le Marchand L, Leminen A, Lester J, Levine DA, Li J, Liang D, Lindblom A, Lindor N, Lissowska J, Long J, Lu KH, Lubinski J, Lundvall L, Lurie G, Mai PL, Mannermaa A, Margolin S, Mariette F, Marme F, Martens JWM, Massuger LFAG, Maugard C, Mazoyer S, McGuffog L, McGuire V, McLean C, McNeish I, Meindl A, Menegaux F, Menéndez P,

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Menkiszak J, Menon U, Mensenkamp AR, Miller N, Milne RL, Modugno F, Montagna M, Moysich KB, Müller H, Mulligan AM, Muranen TA, Narod SA, Nathanson KL, Ness RB, Neuhausen SL, Nevanlinna H, Neven P, Nielsen FC, Nielsen SF, Nordestgaard BG, Nussbaum RL, Odunsi K, Offit K, Olah E, Olopade OI, Olson JE, Olson SH, Oosterwijk JC, Orlow I, Orr N, Orsulic S, Osorio A, Ottini L, Paul J, Pearce CL, Pedersen IS, Peissel B, Pejovic T, Pelttari LM, Perkins J, Permuth-Wey J, Peterlongo P, Peto J, Phelan CM, Phillips K-A, Piedmonte M, Pike MC, Platte R, Plisiecka-Halasa J, Poole EM, Poppe B, Pylkäs K, Radice P, Ramus SJ, Rebbeck TR, Reed MWR, Rennert G, Risch HA, Robson M, Rodriguez GC, Romero A, Rossing MA, Rothstein JH, Rudolph A, Runnebaum I, Salani R, Salvesen HB, Sawyer EJ, Schildkraut JM, Schmidt MK, Schmutzler RK, Schneeweiss A, Schoemaker MJ, Schrauder MG, Schumacher F, Schwaab I, Scuvera G, Sellers TA, Severi G, Seynaeve CM, Shah M, Shrubsole M, Siddiqui N, Sieh W, Simard J, Singer CF, Sinilnikova OM, Smeets D, Sohn C, Soller M, Song H, Soucy P, Southey MC, Stegmaier C, Stoppa-Lyonnet D, Sucheston L, SWE-BRCA, Swerdlow A, Tangen IL, Tea M-K, Teixeira MR, Terry KL, Terry MB, Thomassen M, Thompson PJ, Tihomirova L, Tischkowitz M, Toland AE, Tollenaar RAEM, Tomlinson I, Torres D, Truong T, Tsimiklis H, Tung N, Tworoger SS, Tyrer JP, Vachon CM, Van 't Veer LJ, van Altena AM, Van Asperen CJ, van den Berg D, van den Ouweland AMW, van Doorn HC, Van Nieuwenhuysen E, van Rensburg EJ, Vergote I, Verhoef S, Vierkant RA, Vijai J, Vitonis AF, Wachenfeldt Av, Walsh C, Wang Q, Wang-Gohrke S, Wappenschmidt B, Weischer M, Weitzel JN, Weltens C, Wentzensen N, Whittemore AS, Wilkens LR, Winqvist R, Wu AH, Wu X, Yang HP, Zaffaroni D, Zamora MP, Zheng W, Ziogas A, Chenevix-Trench G, Pharoah PDP, Rookus MA, Hooning MJ, Goode EL. No clinical utility of KRAS variant rs61764370 for ovarian or breast cancer. Gynecol Oncol 2016;141(2):386-401. PMCID: PMC4630206.

Kar SP, Beesley J, Al Olama AA, Michailidou K, Tyrer J, Kote-Jarai ZS, Lawrenson K, Lindstrom S, Ramus SJ, Thompson DJ, ABCTB Investigators, Kibel AS, Dansonka-Mieszkowska A, Michael A, Dieffenbach AK, Gentry-Maharaj A, Whittemore AS, Wolk A, Monteiro A, Peixoto A, Kierzek A, Cox A, Rudolph A, Gonzalez-Neira A, Wu AH, Lindblom A, Swerdlow A, AOCS Study Group, Australian Cancer Study (Ovarian Cancer), APCB BioResource, Ziogas A, Ekici AB, Burwinkel B, Karlan BY, Nordestgaard BG, Blomqvist C, Phelan C, McLean C, Pearce CL, Vachon C, Cybulski C, Slavov C, Stegmaier C, Maier C, Ambrosone CB, Høgdall CK, Teerlink CC, Kang D, Tessier DC, Schaid DJ, Stram DO, Cramer DW, Neal DE, Eccles D, Flesch-Janys D, Edwards DRV, Wokozorczyk D, Levine DA, Yannoukakos D, Sawyer EJ, Bandera EV, Poole EM, Goode EL, Khusnutdinova E, Høgdall E, Song F, Bruinsma F, Heitz F, Modugno F, Hamdy FC, Wiklund F, Giles GG, Olsson H, Wildiers H, Ulmer H-U, Pandha H, Risch HA, Darabi H, Salvesen HB, Nevanlinna H, Gronberg H, Brenner H, Brauch H, Anton-Culver H, Song H, Lim H-Y, McNeish I, Campbell I, Vergote I, Gronwald J, Lubi ski J, Stanford JL, Benítez J, Doherty JA, Permuth JB, Chang-Claude J, Donovan JL, Dennis J, Schildkraut JM, Schleutker J, Hopper JL, Kupryjanczyk J, Park JY, Figueroa J, Clements JA, Knight JA, Peto J, Cunningham JM, Pow-Sang J, Batra J, Czene K, Lu KH, Herkommer K, Khaw K-T, kConFab Investigators, Matsuo K, Muir K, Offitt K, Chen K, Moysich KB, Aittomäki K, Odunsi K, Kiemeney LA, Massuger LFAG, Fitzgerald LM, Cook LS, Cannon-Albright L, Hooning MJ, Pike MC, Bolla MK, Luedeke M, Teixeira MR, Goodman MT, Schmidt MK, Riggan M, Aly M, Rossing MA, Beckmann MW, Moisse M, Sanderson M, Southey MC, Jones M, Lush M, Hildebrandt MAT, Hou M-F, Schoemaker MJ, Garcia-Closas M, Bogdanova N, Rahman N, NBCS Investigators, Le ND, Orr N, Wentzensen N, Pashayan N, Peterlongo P, Guénel P, Brennan P, Paulo P, Webb PM, Broberg P, Fasching PA, Devilee P, Wang Q, Cai Q, Li Q, Kaneva R, Butzow R, Kopperud RK, Schmutzler RK,

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Stephenson RA, MacInnis RJ, Hoover RN, Winqvist R, Ness R, Milne RL, Travis RC, Benlloch S, Olson SH, McDonnell SK, Tworoger SS, Maia S, Berndt S, Lee SC, Teo S-H, Thibodeau SN, Bojesen SE, Gapstur SM, Kjær SK, Pejovic T, Tammela TL, GENICA Network, PRACTICAL consortium, Dörk T, Brüning T, Wahlfors T, Key TJ, Edwards TL, Menon U, Hamann U, Mitev V, Kosma V-M, Setiawan VW, Kristensen V, Arndt V, Vogel W, Zheng W, Sieh W, Blot WJ, Kluzniak W, Shu X-O, Gao Y-T, Schumacher F, Freedman ML, Berchuck A, Dunning AM, Simard J, Haiman CA, Spurdle A, Sellers TA, Hunter DJ, Henderson BE, Kraft P, Chanock SJ, Couch FJ, Hall P, Gayther SA, Easton DF, Chenevix-Trench G, Eeles R, Pharoah PDP, Lambrechts D. Genome-wide meta-analyses of breast,ovarian and prostate cancer association studies identify multiple new susceptibility loci shared by at least two cancer types. Cancer Discov 2016;6(9):1052-67. PMCID: PMC5010513.

Gharahkhani P, Fitzgerald RC, Vaughan TL, Tomlinson I, Gockel I, Palles C, Buas MF, May A, Gerges C, Anders M, Becker J, Kreuser N, Noder T, Venerito M, Veits L, Schmidt T, Manner H, Schmidt C, Hess T, Böhmer AC, Izbicki JR, Hölscher AH, Lang H, Lorenz D, Schumacher B, Hackelsberger A, Mayershofer R, Pech O, Vashist Y, Ott K, Vieth M, Weismüller J, Nöthen MM, Barrett’s and Esophageal Adenocarcinoma Consortium (BEACON), Wellcome Trust Case-Control Consortium (WTCCC), Attwood S, Barr H, Chegwidden L, deCaestecker J, Harrison R, Love SB, MacDonald D, Moayyedi P, Prenen H, Watson RGP, Iyer PG, Anderson LA, Bernstein L, Chow W-H, Hardie LJ, Lagergren J, Liu G, Risch HA, Wu AH, Ye W, Bird NC, Shaheen NJ, Gammon MD, Corley DA, Caldas C, Moebus S, Knapp M, Peters WHM, Neuhaus H, Rösch T, Ell C, MacGregor S, Pharoah P, Whiteman DC, Jankowski J, Schumacher J. Genome-wide association studies in oesophageal adenocarcinoma and Barrett’s oesophagus: a large-scale meta-analysis. Lancet Oncol 2016;17(10):1363-73. PMCID: PMC5052458.

Dai J, Tapsoba J de D, Bernstein L, Chow W-H, Shaheen NJ, Anderson L, Liu G, Iyer P, Reid BJ, Wu AH, Corley DA, Gammon MD, Hardie LJ, Risch HA, Bird NC, Lagergren J, Ye W, Whiteman DC, Vaughan TL. Constrained score statistics identify novel genetic variants interacting with multiple risk factors in Barrett's Esophagus. Am J Hum Genet 2016;99(2):352-65. PMCID: PMC4974090.

Lujan-Barroso L, Zhang W, Olson SH, Gao Y-T, Yu H, Baghurst PA, Bracci PM, Bueno-de-Mesquita HB, Foretová L, Gallinger S, Holcatova I, Janout V, Ji B-T, Kurtz RC, La Vecchia C, Lagiou P, Li D, Miller AB, Serraino D, Zatonski W, Risch HA, Duell EJ. Menstrual and reproductive factors, hormone use and risk of pancreatic cancer: analysis from the International Pancreatic Cancer Case-Control Consortium (PanC4). Pancreas 2016;45(10):1401-10.PMCID: PMC5065728.

Kho PF, Fawcett J, Fritschi L, Risch H, Webb PM, Whiteman DC, Neale RE. Nonsteroidal anti-inflammatory drugs, statins and pancreatic cancer risk: a population-based case-control study. Cancer Causes Control 2016;27(12):1457-64. *Not a result of NIH funding.

Drahos J, Xiao Q, Risch HA, Freedman ND, Abnet CC, Anderson LA, Bernstein L, Brown L, Chow W-H, Gammon MD, Kamangar F, Liao LM, Murray LJ, Ward MH, Ye W, Wu AH, Vaughan TL, Whiteman DC, Cook MB. Age-specific risk factor profiles of adenocarcinomas of the esophagus: a pooled analysis from the International BEACON Consortium. Int J Cancer2016;138(1):55-64. PMCID: PMC4607633.

Shi J, Park J-H, Duan J, Berndt S, Moy W, Yu K, Song L, Wheeler W, Hua X, Silverman D, Garcia-Closas M, Hsiung CA, Figueroa JD, Cortessis VK, Malats N, Karagas MR, Vineis P, Chang I-S, Lin D, Zhou B, Seow A, Matsuo K, Hong Y-C, Caporaso NE, Wolpin B, Jacobs E, Petersen G, Klein AP, Li D, Risch H, Sanders AR, Hsu L, Schoen RE, Brenner H, MGS

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(Molecular Genetics of Schizophrenia) GWAS Consortium, GECCO (The Genetics and Epidemiology of Colorectal Cancer Consortium), The GAME-ON/TRICL (Transdisciplinary Research in Cancer of the Lung) GWAS Consortium, PRACTICAL (PRostate cancer AssoCiation group To Investigate Cancer Associated aLterations) Consortium, PanScan and PanC4 Consortium, The GAMEON/ ELLIPSE Consortium, Stolzenberg-Solomon R, Gejman P, Lan Q, Rothman N, Amundadottir LT, Landi MT, Levinson DF, Chanock SJ, Chatterjee N. Winner’s curse correction and variable thresholding improve performance of polygenic risk modeling based on genome-wide association study summary-level data. PLoS Genet 2016;12(12):e1006493. PMCID: PMC5201242.

McWilliams RR, Maisonneuve P, Bamlet WR, Petersen GM, Li D, Risch HA, Yu H, Fontham ET, Luckett B, Bosetti C, Negri E, La Vecchia C, Talamini R, Bueno de Mesquita HB, Bracci P, Gallinger S, Neale RE, Lowenfels AB. Risk factors for early-onset and very-early-onset pancreatic adenocarcinoma: a Pancreatic Cancer Case-Control Consortium (PanC4) analysis. Pancreas 2016;45(2):311-6. PMCID: PMC4710562.

Kotsopoulos J, Rosen B, Fan I, Moody J, McLaughlin JR, Risch H, May T, Sun P, Narod SA. Ten-year survival after epithelial ovarian cancer is not associated with BRCA mutation status. Gynecol Oncol 2016;140(1):42-7. *NIH funding pre-dates mandate.

Ek WE, Lagergren K, Cook M, Wu AH, Abnet CC, Levine D, Chow W-H, Bernstein L, Risch HA,Shaheen NJ, Bird NC, Corley DA, Hardie LJ, Fitzgerald RC, Gammon M, Romero Y, Liu G, Ye W, Vaughan TL, MacGregor S, Whiteman DC, Westberg L, Lagergren J. Polymorphisms in genes in the androgen pathway and risk of Barrett’s Esophagus and esophageal adenocarcinoma. Int J Cancer 2016;138(5):1146-52. PMCID: PMC4715576.

Lu L, Katsaros D, Risch HA, Canuto EM, Biglia N, Yu H. MicroRNA let-7a modifies the effect of self-renewal gene HIWI on patient survival of epithelial ovarian cancer. Mol Carcinog2016;55(4):357-65. *Not a result of NIH funding.

Præstegaard C, Kjaer, SK, Nielsen TSS, Jensen SM, Webb PM, Australian Ovarian Cancer Study Group, Nagle CM, Høgdall E, Risch HA, Rossing MA, Doherty JA, Wicklund KG, Goodman MT, Modugno F, Moysich K, Ness RB, Edwards RP, Goode EL, Winham SJ, Fridley BL, Cramer DW, Terry KL, Schildkraut JM, Berchuck A, Bandera EV, Paddock L, Kiemeney LA, Massuger LF, Wentzensen N, Pharoah P, Song H, Whittemore AS, McGuire V, Sieh W, Rothstein J, Anton-Culver H, Ziogas A, Menon U, Gayther SA, Ramus SJ, Gentry-Maharaj A, Wu AH, Pearce CL, Pike MC, Lee AW, Chang-Claude J, Jensen A, Ovarian Cancer Association Consortium. The association between socioeconomic status and tumour stage at diagnosis of ovarian cancer: a pooled analysis of 18 case-control studies. Cancer Epidemiol 2016;41:71-9. PMCID: PMC4993452.

Cuellar-Partida G, Lu Y, Dixon SC, Australian Ovarian Cancer Study, Fasching PA, Hein A, Burghaus S, Beckmann MW, Lambrechts D, Van Nieuwenhuysen E, Vergote I, Vanderstichele A, Doherty JA, Rossing MA, Chang-Claude J, Rudolph A, Wang-Gohrke S, Goodman MT, Bogdanova N, Dörk T, Dürst M, Hillemanns P, Runnebaum IB, Antonenkova N, Butzow R, Leminen A, Nevanlinna H, Pelttari LM, Edwards RP, Kelley JL, Modugno F, Moysich KB, Ness RB, Cannioto R, Høgdall E, Høgdall C, Jensen A, Giles GG, Bruinsma F, Kjaer SK, Hildebrandt MAT, Liang D, Lu KH, Wu X, Bisogna M, Dao F, Levine DA, Cramer DW, Terry KL, Tworoger SS, Stampfer M, Missmer S, Bjorge L, Salvesen HB, Kopperud RK, Bischof K, Aben KKH, Kiemeney LA, Massuger LFAG, Brooks-Wilson A, Olson SH, McGuire V, Rothstein JH, Sieh W, Whittemore AS, Cook LS, Le ND, Gilks CB, Gronwald J, Jakubowska A, Lubi ski J, Kluz T, Song H, Tyrer JP, Wentzensen N, Brinton L, Trabert B, Lissowska J,

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McLaughlin JR, Narod SA, Phelan C, Anton-Culver H, Ziogas A, Eccles D, Campbell I, Gayther SA, Gentry-Maharaj A, Menon U, Ramus SJ, Wu AH, Dansonka-Mieszkowska A, Kupryjanczyk J, Timorek A, Szafron L, Cunningham JM, Fridley BL, Winham SJ, Bandera EV, Poole EM, Morgan TK, Goode EL, Schildkraut JM, Pearce CL, Berchuck A, Pharoah PDP, Webb PM, Chenevix-Trench G, Risch HA, MacGregor S. Assessing the genetic architecture of epithelial ovarian cancer histological subtypes. Hum Genet 2016;135(7): 741-56. PMCID: PMC4976079.

Meeks HD, Song H, Michailidou K, Bolla MK, Dennis J, Wang Q, Barrowdale D, Frost D, EMBRACE, McGuffog L, Ellis S, Feng B, Buys SS, Hopper JL, Southey MC, Tesoriero A, kConFab Investigators, James PA, Bruinsma F, Campbell IG, Australia Ovarian Cancer Study Group, Broeks A, Schmidt MK, Hogervorst FBL, HEBON, Beckman MW, Fasching PA, Fletcher O, Johnson N, Sawyer EJ, Riboli E, Banerjee S, Menon U, Tomlinson I, Burwinkel B, Hamann U, Marme F, Rudolph A, Janavicius R, Tihomirova L, Tung N, Garber J, Cramer D, Terry KL, Poole EM, Tworoger SS, Dorfling CM, van Rensburg EJ, Godwin AK, Guénel P, Truong T, GEMO Study Collaborators, Stoppa-Lyonnet D, Damiola F, Mazoyer S, Sinilnikova OM, Isaacs C, Maugard C, Bojesen SE, Flyger H, Gerdes A-M, Hansen TVO, Jensen A, Kjaer SK, Hogdall C, Hogdall E, Pedersen IS, Thomassen M, Benitez J, González-Neira A, Osorio A, de la Hoya M, Perez Segura P, Diez O, Lazaro C, Brunet J, Anton-Culver H, Eunjung L, John EM, Neuhausen SL, Ding YC, Castillo D, Weitzel JN, Ganz PA, Nussbaum RL, Chan SB, Karlan BY, Lester J, Wu A, Gayther S, Ramus SJ, Sieh W, Whittermore AS, Monteiro ANA, Phelan CM, Terry MB, Piedmonte M, Offit K, Robson M, Levine D, Moysich KB, Cannioto R, Olson SH, Daly MB, Nathanson KL, Domchek SM, Lu KH, Liang D, Hildebrant MAT, Ness R, Modugno F, Pearce L, Goodman MT, Thompson PJ, Brenner H, Butterbach K, Meindl A, Hahnen E, Wappenschmidt B, Brauch H, Brüning T, Blomqvist C, Khan S, Nevanlinna H, Pelttari LM, Aittomäki K, Butzow R, Bogdanova NV, Dörk T, Lindblom A, Margolin S, Rantala J, Kosma V-M, Mannermaa A, Lambrechts D, Neven P, Claes KBM, Van Maerken T, Chang-Claude J, Flesch-Janys D, Heitz F, Varon-Mateeva R, Peterlongo P, Radice P, Viel A, Barile M, Peissel B, Manoukian S, Montagna M, Oliani C, Peixoto A, Teixeira MR, Collavoli A, Hallberg E, Olson JE, Goode EL, Hart S, Shimelis H, Cunningham JM, Giles GG, Milne RL, Healey S, Tucker K, Haiman CA, Henderson BE, Goldberg MS, Tischkowitz M, Simard J, Soucy P, Eccles DM, Le N, Borresen-Dale A-L, Kristensen V, Salvesen HB, Bjorge L, Bandera EV, Risch H, Zheng W, Beeghly-Fadiel A, Cai H, Pylkäs K, Tollenaar RAEM, van der Ouweland AMW, Andrulis IL, Knight JA, OCGN, Narod S, Devilee P, Winqvist R, Figueroa J, Greene MH, Mai PL, Loud JT, García-Closas M, Schoemaker MJ, Czene K, Darabi H, McNeish I, Siddiquil N, Glasspool R, Kwong A, Park SK, Teo SH, Yoon S-Y, Matsuo K, Hosono S, Woo YL, Gao Y-T, Foretova L, Singer CF, Feurhauser CR, Friedman E, Laitman Y, Rennert G, Imyanitov EN, Hulick PJ, Olopade OI, Senter L, Olah E, Doherty JA, Schildkraut J, Hollestelle A, Koppert LB, Kiemeney LA, Massuger LFAG, Cook LS, Pejovic T, Li J, Borg A, Öfverholm A, Rossing MA, Wentzensen N, Henriksson K, Cox A, Cross SS, Perkins BJ, Shah M, Kabisch M, Torres D, Jakubowska A, Lubinski J, Gronwald J, Agnarsson BA, Kupryjanczyk J, Moes-Sosnowska J, Fostira F, Konstantopoulou I, Slager S, Jones M, Prostate Cancer Association Group to Investigate Cancer Associated Alterations in the Genome, Antoniou AC, Berchuck A, Swerdlow A, Chenevix-Trench G, Dunning AM, Pharoah PDP, Hall P, Easton DF, Couch FJ, Spurdle AB, Goldgar DE. BRCA2 polymorphic stop codon K3326X and the risk of breast, prostate and ovarian cancers. J Natl Cancer Inst2016;108(2):djv315. PMCID: PMC4907358.

2015

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Risch HA, Yu H, Lu L, Kidd MS. Detectable symptomatology preceding the diagnosis of pancreatic cancer and absolute risk of pancreatic cancer diagnosis. Am J Epidemiol 2015;182(1):26-34. PMCID: PMC4479115.

Schulte A, Pandeya N, Fawcett J, Fritschi L, Risch HA, Webb PM, Whiteman DC, Neale RE. Association between Helicobacter pylori and pancreatic cancer risk: a meta-analysis. Cancer Causes Control 2015;26(7):1027-35. *Not a result of NIH funding.

Ivanova A, Loo A, Tworoger S, Crum CP, Fan I, McLaughlin JR, Rosen B, Risch H, Narod SA, Kotsopoulos J. Ovarian cancer survival by tumor dominance, a surrogate for site of origin. Cancer Causes Control 2015;26(4):601-8. *NIH funding pre-dates mandate.

Wang Z, Katsaros D, Shen Y, Fu Y, Canuto EM, Benedetto C, Lu L, Chu W-M, Risch HA, Yu H. Biological and clinical significance of MAD2L1 and BUB1, genes frequently appearing in expression signatures for breast-cancer prognosis. PLoS One 2015;10(8):e0136246. PMCID: PMC4546117.

Waterhouse M, Risch HA, Bosetti C, Anderson KE, Petersen GM, Bamlet WR, Cotterchio M, Cleary SP, Ibiebele T, La Vecchia C, Skinner H, Strayer L, Bracci PM, Maisonneuve P, Bueno-de-Mesquita HB, Zato ski W, Lu L, Yu H, Janik-Koncewicz K, Polesel J, Serraino D, Neale RE, for the Pancreatic Cancer Case-Control Consortium (PanC4). Vitamin D and pancreatic cancer: a pooled analysis from the Pancreatic Cancer Case-Control Consortium. Ann Oncol 2015;26(8):1776-83. PMCID: PMC4511221.

Amankwah EK, Lin H-Y, Tyrer JP, Lawrenson K, Dennis J, Chornokur G, Aben KKH, Anton-Culver H, Antonenkova N, Bruinsma F, Bandera EV, Bean YT, Beckmann MW, Bisogna M, Bjorge L, Bogdanova N, Brinton LA, Brooks-Wilson A, Bunker CH, Butzow R, Campbell IG, Carty K, Chen Z, Chen YA, Chang-Claude J, Cook LS, Cramer DW, Cunningham JM, Cybulski C, Dansonka-Mieszkowska A, du Bois A, Despierre E, Dicks E, Doherty JA, Dörk T, Dürst M, Easton DF, Eccles DM, Edwards RP, Ekici AB, Fasching PA, Fridley BL, Gao Y-T, Gentry-Maharaj A, Giles GG, Glasspool R, Goodman MT, Gronwald J, Harrington P, Harter P, Hasmad HN, Hein A, Heitz F, Hildebrandt MAT, Hillemanns P, Hogdall CK, Hogdall E, Hosono S, Iversen ES, Jakubowska A, Jensen A, Ji B-T, Karlan BY, Jim H, Kellar M, Kiemeney LA, Krakstad C, Kjaer SK, Kupryjanczyk J, Lambrechts D, Lambrechts S, Le ND, Lee AW, Lele S, Leminen A, Lester J, Levine DA, Liang D, Lim BK, Lissowska J, Lu K, Lubinski J, Lundvall L, Massuger L FAG, Matsuo K, McGuire V, McLaughlin JR, McNeish I, Menon U, Milne RL, Modugno F, Moysich KB, Ness RB, Nevanlinna H, Eilber U, Odunsi K, Olson SH, Orlow I, Orsulic S, Weber RP, Paul J, Pearce CL, Pejovic T, Pelttari LM, Permuth-Wey J, Pike MC, Poole EM, Risch HA, Rosen B, Rossing MA, Rothstein JH, Rudolph A, Runnebaum IB, Rzepecka IK, Salvesen HB, Schernhammer E, Schwaab I, Shu X-O, Shvetsov YB, Siddiqui N, Sieh W, Song H, Southey MC, Spiewankiewicz B, Sucheston-Campbell L, Teo S-H, Terry KL, Thompson PJ, Thomsen L, Tangen IL, Tworoger SS, van Altena AM, Vierkant RA, Vergote I, Walsh CS, Wang-Gohrke S, Wentzensen N, Whittemore AS, Wicklund KG, Wilkens LR, Wu AH, Wu X, Woo Y-L, Yang H, Zheng W, Ziogas A, Kelemen LE, Berchuck A, Chenevix-Trench G on behalf of the AOCS management group, Schildkraut JM, Ramus SJ, Goode EL, Monteiro ANA, Gayther SA, Narod SA, Pharoah PDP, Sellers TA, Phelan CM. Epithelial-mesenchymal transition (EMT) gene variants and epithelial ovarian cancer (EOC) risk. Genet Epidemiol 2015;39(8):689-97. PMCID: PMC4721602.

Collaborative Group on Epidemiological Studies of Ovarian Cancer. Menopausal hormone use and ovarian cancer risk: Individual participant meta-analysis of 52 epidemiological studies. Lancet2015;385:1835-42. *Not a result of NIH funding.

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Wang Z, Risch H, Lu L, Irwin M, Mayne S, Schwartz P, Rutherford T, De Vivo I, Yu H. Joint effect of genotypic and phenotypic features of reproductive factors on endometrial cancer risk. Sci Rep 2015;5:15582. PMCID: PMC Journal in Process.

Machiela MJ, Zhou W, Sampson JN, Dean MC, Jacobs KB, Black A, Brinton LA, Chang I-S, Chen C, Chen C, Chen K, Cook LS, Crous Bou M, De Vivo I, Doherty J, Friedenreich CM, Gaudet MM, Haiman CA, Hankinson SE, Hartge P, Henderson BE, Hong Y-C, Hosgood III HD, Hsiung CA, Hu W, Hunter DJ, Jessop L, Kim HN, Kim YH, Kim YT, Klein R, Kraft P, Lan Q, Lin D, Liu J, Le Marchand L, Liang X, Lissowska J, Lu L, Magliocco AM, Matsuo K, Olson SH, Orlow I, Park JY, Pooler L, Prescott J, Rastogi R, Risch HA, Schumacher F, Seow A, Setiawan VW, Shen H, Sheng X, Shin M-H, Shu X-O, VanDen Berg D, Wang J-C, Wentzensen N, Wong MP, Wu C, Wu T, Wu Y-L, Xia L, Yang HP, Yang P-C, Zheng W, Zhou B, Abnet CC, Albanes D, Aldrich MC, Amos C, Amundadottir LT, Berndt SI, Blot WJ, Bock CH, Bracci PM, Burdett L, Buring JE, Butler MA, Carreón T, Chatterjee N, Chung CC, Cook MB, Cullen M, Davis FG, Ding T, Duell EJ, Epstein CG, Fan J-H, Figueroa JD, Fraumeni Jr. JF, Freedman ND, Fuchs CS, Gao Y-T, Gapstur SM, Patiño-Garcia A, Garcia-Closas M, Gaziano JM, Giles GG, Gillanders EM, Giovannucci EL, Goldin L, Goldstein AM, Greene MH, Hallmans G, Harris CC, Henriksson R, Holly EA, Hoover RN, Hu N, Hutchinson A, Jenab M, Johansen C, Khaw K-T, Koh W-P, Kolonel LN, Kooperberg C, Krogh V, Kurtz RC, LaCroix A, Landgren A, Landi MT, Li D, Liao LM, Malats N, McGlynn KA, McNeill LH, McWilliams RR, Melin BS, Mirabello L, Peplonska B, Peters U, Petersen GM, Prokunina-Olsson L, Purdue M, Qiao Y-L, Rabe KG, Rajaraman P, Real FX, Riboli E, Rodriguez-Santiago B, Rothman N, Ruder AM, Savage SA, Schwartz AG, Schwartz KL, Sesso HD, Severi G, Silverman DT, Spitz MR, Stevens VL, Stolzenberg-Solomon R, Stram D, Tang Z-Z, Taylor PR, Teras LR, Tobias GS, Viswanathan K, Wacholder S, Wang Z, Weinstein SJ, Wheeler W, White E, Wiencke JK, Wolpin BM, Wu X, Wunder JS, Yu K, Zanetti KA, Zeleniuch-Jacquotte A, Ziegler RG, de Andrade M, Barnes KC, Beaty TH, Bierut LJ, Desch KC, Doheny KF, Feenstra B, Ginsburg D, Heit JA, Kang JH, Laurie CA, Li JZ, Lowe WL, Marazita ML, Melbye M, Mirel DB, Murray J, Nelson SC, Pasquale LR, Rice K, Wiggs JL, Wise A, Tucker M, Perez-Jurado LA, Laurie CC, Caporaso NE, Yeager M, Chanock SJ. Characterization of large structural genetic mosaicism in human autosomes. Am J Hum Genet 2015;96(3):487-97.PMCID: PMC Journal in Process.

Fritschi L, Benke G, Risch HA, Schulte A, Webb PM, Whiteman DC, Fawcett J, Neale RE. Occupational exposure to N-nitrosamines and pesticides and risk of pancreatic cancer. Occup Environ Med 2015;72(9):678-83. *Not a result of NIH funding.

Salmena L, Shaw P, Fan I, McLaughlin JR, Rosen B, Risch H, Mitchell C, Sun P, Narod SA, Kotsopoulos J. Prognostic value of INPP4B protein immunohistochemistry in ovarian cancer.Eur J Gynaecol Oncol 2015;36(3):260-7. PMCID: PMC Journal in Process.

Lee E, Stram DO, Ek W, Onstad LE, MacGregor S, Buas M, Gharahkhani P, Ye W, Lagergren J, Bird NC, Romero Y, Shaheen NJ, Murray LJ, Hardie LJ, Gammon MD, Chow W-H, Risch HA, Corley DA, Reid BJ, Levine DM, Abnet C, Whiteman DC, Bernstein L, Vaughan TL, Wu AH. Pleiotropic analysis of cancer risk loci on esophageal adenocarcinoma risk. Cencer Epidemiol Biomarkers Prev 2015;24(11):1801-3. PMCID: PMC Journal in Process.

Prescott J, Setiawan VW, Wentzensen N, Schumacher F, Yu H, Delahanty R, Bernstein L, Chanock SJ, Chen C, Cook LS, Friedenreich C, Garcia-Closas M, Haiman CA, Le Marchand L, Liang X, Lissowska J, Lu L, Magliocco AM, Olson SH, Risch HA, Shu X-O, Ursin G, Yang HP, Kraft P, De Vivo I. Body mass index genetic risk score and endometrial cancer risk. PLoS One

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2015;10(11):e0143256. PMCID: PMC Journal in Process. Petrick JL, Steck SE, Bradshaw PT, Chow W-H, Engel LS, He K, Risch HA, Vaughan TL,

Gammon MD. Dietary flavonoid intake and Barrett’s Esophagus in western Washington State. Ann Epidemiol 2015;25(10):730-5.e2. PMCID: PMC Journal in Process.

Dai JY, Tapsoba Jde D, Buas MF, Onstad LE, DM, Risch HA, Chow W-H, Bernstein L, Ye W, Lagergren J, Bird NC, Corley DA, Shaheen NJ, Wu AH, Reid BJ, Hardie LJ, Whiteman DC, Vaughan TL. A newly identified susceptibility locus near FOXP1 modifies the association of gastroesophageal reflux with Barrett’s Esophagus. Cancer Epidemiol Biomarkers Prev2015;24(11):1739-47. PMCID: PMC Journal in Process.

Shen Y, Wang Z, Loo LWM, Ni Y, Jia W, Fei P, Risch HA, Katsaros D, Yu H. LINC00472expression is regulated by promoter methylation and associated with disease-free survival in patients with grade 2 breast cancer. Breast Cancer Res Treat 2015;154(3):473-82. *Not a result of NIH funding.

Lagergren K, Ek WE, Levine D, Chow W-H, Bernstein L, Casson AG, Risch HA, Shaheen NJ, Bird NC, Reid BJ, Corley DA, Hardie LJ, Wu AH, Fitzgerald RC, Pharoah P, Caldas C, Romero Y, Vaughan TL, MacGregor S, Whiteman D, Westberg L, Nyren O, Lagergren J. Polymorphisms in genes of relevance for oestrogen and oxytocin pathways and risk of Barrett’s Oesophagus and oesophageal adenocarcinoma: a pooled analysis from the BEACON Consortium. PLoS ONE 2015;10(9):e0138738. PMCID: PMC Journal in Process.

Kar SP, Tyrer JP, Li Q, Lawrenson K, Aben KKH, Anton-Culver H, Antonenkova N, Chenevix-Trench G, Australian Cancer Study, Australian Ovarian Cancer Study Group, Baker H, Bandera EV, Bean YT, Beckmann MW, Berchuck A, Bisogna M, Bjørge L, Bogdanova N, Brinton L, Brooks-Wilson A, Butzow R, Campbell I, Carty K, Chang-Claude J, Chen YA, Chen Z, Cook LS, Cramer D, Cunningham JM, Cybulski C, Dansonka-Mieszkowska A, Dennis J, Dicks E, Doherty JA, Dörk T, du Bois A, Dürst M, Eccles D, Easton DF, Edwards RP, Ekici AB, Fasching PA, Fridley BL, Gao Y-T, Gentry-Maharaj A, Giles GG, Glasspool R, Goode EL, Goodman MT, Grownwald J, Harrington P, Harter P, Hein A, Heitz F, Hildebrandt MAT, Hillemanns P, Hogdall E, Hogdall CK, Hosono S, Iversen ES, Jakubowska A, James P, Jensen A, Ji B-T, Karlan BY, Kjaer SK, Kelemen LE, Kellar M, Kelley J, Kiemeney LA, Krakstad C, Kupryjanczyk J, Lambrechts D, Lambrechts S, Le ND, Lee AW, Lele S, Leminen A, Lester J, Levine DA, Liang D, Lissowska J, Lu K, Lubinski J, Lundvall L, Massuger L, Matsuo K, McGuire V, McLaughlin JR, McNeish IA, Menon U, Modugno F, Moysich KB, Narod SA, Nedergaard L, Ness RB, Nevanlinna H, Odunsi K, Olson SH, Orlow I, Orsulic S, Weber RP, Pearce CL, Pejovic T, Pelttari LM, Permuth-Wey J, Phelan CM, Pike MC, Poole EM, Ramus SJ, Risch HA, Rosen B, Rossing MA, Rothstein JH, Rudolph A, Runnebaum IB, Rzepecka IK, Salvesen HB, Schildkraut JM, Schwaab I, Shu X-O, Shvetsov YB, Siddiqui N, Sieh W, Song H, Southey MC, Sucheston-Campbell LE, Tangen IL, Teo S-H, Terry KL, Thompson PJ, Timorek A, Tsai Y-Y, Tworoger SS, van Altena AM, Van Nieuwenhuysen E, Vergote I, Vierkant RA, Wang-Gohrke S, Walsh C, Wentzensen N, Whittemore AS, Wicklund KG, Wilkens LR, Woo Y-L, Wu X, Wu A, Yang H, Zheng W, Ziogas A, Sellers TA, Monteiro ANA, Freedman ML, Gayther SA, Pharoah PDP. Network-based integration of GWAS and gene expression identifies a HOX-centric network associated with serous ovarian cancer risk. Cancer Epidemiol Biomarkers Prev 2015;24(10):1574-84. PMCID: PMC Journal in Process.

Felix AS, Gaudet MM, La Vecchia C, Nagle CM, Shu X-O, Weiderpass E, Adami HO, Beresford S, Bernstein L, Chen C, Cook LS, De Vivo I, Doherty JA, Friedenreich CM, Gapstur SM, Hill D, Horn-Ross PL, Lacey JV, Levi F, Liang X, Lu L, Magliocco A, McCann SE, Negri E, Olson

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SH, Palmer JR, Patel AV, Petruzella S, Prescott J, Risch HA, Rosenberg L, Sherman ME, Spurdle AB, Webb PM, Wise LA, Xiang Y-B, Xu W, Yang HP, Yu H, Zeleniuch-Jacquotte A, Brinton LA. Intrauterine devices and endometrial cancer risk: a pooled analysis of the Epidemiology of Endometrial Cancer Consortium. Int J Cancer 2015;136(5):E410-22.PMCID: PMC Journal in Process.

Lee AW, Tyrer JP, Doherty JA, Stram DA, Kupryjanczyk J, Dansonka-Mieszkowska A, Plisiecka-Halasa J, Spiewankiewicz B, Myers EJ, Australian Cancer Study (Ovarian Cancer), Australian Ovarian Cancer Study Group, Chenevix-Trench G, Fasching PA, Beckmann MW, Ekici AB, Hein A, Vergote I, Nieuwenhuysen EV, Lambrechts D, Wicklund KG, Eilber U, Wang-Gohrke S, Chang-Claude J, Rudolph A, Sucheston L, Odunsi K, Moysich KB, Shvetsov YB, Thompson PJ, Goodman MT, Wilkens LR, Dörk T, Hillemanns P, Dürst M, Runnebaum IB, Bogdanova N, Pelttari LM, Nevanlinna H, Leminen A, Edwards RP, Kelley JL, Harter P, Schwaab I, Heitz F, du Bois A, Orsulic S, Lester J, Walsh C, Karlan BY, Hogdall E, Kjaer SK, Jensen A, Vierkant RA, Cunningham JM, Goode EL, Fridley BL, Southey MC, Giles GG, Bruinsma F, Wu X, Hildebrandt MAT, Lu K, Liang D, Bisogna M, Levine DA, Weber RP, Schildkraut JM, Iversen ES, Berchuck A, Terry KL, Cramer DW, Tworoger SS, Poole EM, Olson SH, Orlow I, Bandera EV, Bjorge L, Tangen IL, Salvesen HB, Krakstad C, Massuger LFAG, Kiemeney LA, Aben KKH, van Altena AM, Bean Y, Pejovic T, Kellar M, Le ND, Cook LS, Kelemen LE, Brooks-Wilson A, Lubinski J, Gronwald J, Cybulski C, Jakubowska A, Wentzensen N, Brinton LA, Lissowska J, Yang H, Nedergaard L, Lundvall L, Hogdall C, Song H, Campbell IG, Eccles D, Glasspool R, Siddiqui N, Carty K, Paul J, McNeish I, Sieh W, McGuire V, Rothstein JH, Whittemore AS, McLaughlin JR, Risch HA, Phelan CM, Anton-Culver H, Ziogas A, Menon U, Ramus SJ, Gentry-Maharaj A, Harrington P, Pike MC, Modugno F, Rossing MA, Ness RB, Pharoah PDP, Stram DO, Wu AH, Pearce CL. Evaluating the ovarian cancer gonadotropin hypothesis: a candidate gene study. Gyn Oncol 2015;136(3):542-8. PMCID: PMC Journal in Process.

Campa D, Rizzato C, Stolzenberg-Solomon R, Pacetti P, Vodicka P, Cleary SP, Capurso G, Bueno-de-Mesquita HB, Werner J, Gazouli M, Butterbach K, Ivanauskas A, Giese N, Petersen GM, Fogar P, Wang Z, Bassi C, Ryska M, Theodoropoulos GE, Kooperberg C, Hassan M, Greenhalf W, Pasquali C, Hackert T, Fuchs CS, Mohelnikova-Duchonova B, Sperti C, Funel N, Dieffenbach AK, Wareham NJ, Buring J, Holcátová I, Costello E, Zambon C-F, Kupcinskas J, Risch HA, Kraft P, Bracci PM, Pezzilli R, Olson SH, Sesso HD, Hartge P, Strobel O, Małecka-Panas E, Visvanathan K, Arslan AA, Pedrazzoli S, Sou ek P, Gioffreda D, Key TJ, Talar-Wojnarowska R, Scarpa A, Mambrini A, Jacobs EJ, Jamroziak K, Klein A, Tavano F, Bambi F, Landi S, Austin MA, Vodickova L, Brenner H, Chanock SJ, Delle Fave G, Piepoli A, Cantore M, Zheng W, Wolpin BM, Amundadottir LT, Canzian F. The TERT gene harbors multiple variants associated with pancreatic cancer susceptibility. Int J Cancer 2015;137(9):2175-83.PMCID: PMC Journal in Process.

Lu Y, Cuellar G, Painter JN, Nyholt D, Australian Ovarian Cancer Study, The International Endogene Consortium, Morris AP, Fasching PA, Hein A, Burghaus S, Beckmann MW, Lambrechts; D, Van Nieuwenhuysen E, Vergote I, Vanderstichele A, Doherty JA, Rossing MA, Wicklund KG, Chang-Claude J, Eilber U, Rudolph A, Wang-Gohrke S, Goodman MT, Bogdanova N, Dörk T, Dürst M, Hillemanns P, Runnebaum IB, Antonenkova N, Butzow R, Leminen A, Nevanlinna H, Pelttari LM, Edwards RP, Kelley JL, Modugno F, Moysich KB, Ness RB, Cannioto R, Høgdall E, Jensen A, Giles GG, Bruinsma F, Kjaer SK, Hildebrandt MAT, Liang D, Lu KH, Wu X, Bisogna M, Dao F, Levine DA, Cramer DW, Terry KL, Tworoger SS, Missmer S, Bjorge L, Salvesen HB, Kopperud RK, Bischof K, Aben KKH,

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Kiemeney LA, Massuger LFAG, Brooks-Wilson A, Olson SH, McGuire V, Rothstein JH, Sieh W, Whittemore AS, Cook LS, Le ND, Gilks CB, Gronwald J, Jakubowska A, Lubi ski J, Gawełko J, Song H, Tyrer JP, Wentzensen N, Brinton L, Trabert B, Lissowska J, McLaughlin JR, Narod SA, Phelan C, Anton-Culver H, Ziogas A, Eccles D, Gayther SA, Gentry-Maharaj A, Menon U, Ramus SJ, Wu AH, Dansonka-Mieszkowska A, Kupryjanczyk J, Timorek A, Szafron L, Cunningham JM, Fridley BL, Winham SJ, Bandera EV, Poole EM, Morgan TK, Risch HA, Goode EL, Schildkraut JM, Webb PM, Pearce CL, Berchuck A, Pharoah PDP, Montgomery GW, Zondervan KT, Chenevix-Trench G, Macgregor S. Shared genetics underlying epidemiological association between endometriosis and ovarian cancer. Hum Mol Genet 2015;24(20):5955-64. PMCID: PMC Journal in Process.

Nagle CM, Dixon SC, Jensen A, Kjaer SK, Modugno F, deFazio A, Fereday S, Hung J, Johnatty SE, Australian Ovarian Cancer Study Group, Fasching PA, Beckmann MW, Lambrechts D, Vergote I, Van Nieuwenhuysen E, Lambrechts S, Risch HA, Rossing MA, Doherty JA, Wicklund KG, Chang-Claude J, Goodman MT, Ness RB, Moysich K, Heitz F, du Bois A, Harter P, Schwaab I, Matsuo K, Hosono S, Goode EL, Vierkant RA, Larson MC, Fridley BL, Høgdall C, Schildkraut JM, Weber RP, Cramer DW, Terry KL, Bandera EV, Paddock L, Rodriguez-Rodriguez L, Wentzensen N, Yang HP, Brinton LA, Lissowska J, Høgdall E, Lundvall L, Whittemore A, McGuire V, Sieh W, Rothstein J, Sutphen R, Anton-Culver H, Ziogas A, Pearce CL, Wu AH, Webb PM, Ovarian Cancer Association Consortium. Obesity and survival among women with ovarian cancer: results from the Ovarian Cancer Association Consortium. Br J Cancer 2015;113(5):817-26. PMCID: PMC Journal in Process.

Childs EJ, Mocci E, Campa D, Bracci PM, Gallinger S, Goggins M, Li D, Neale R, Olson SH, Scelo G, Amundadottir LT, Bamlet WR, Bijlsma MF, Blackford A, Borges M, Brennan P, Brenner H, Bueno-de-Mesquita HB, Canzian F, Capurso G, Cavestro GM, Chaffee KG, Chanock SJ, Cleary SP, Cotterchio M, Foretova L, Fuchs C, Funel N, Gazouli M, Hassan M, Herman JM, Holcatova I, Holly EA, Hoover RN, Hung RJ, Janout V, Key TJ, Kupcinskas J, Kurtz RC, Landi S, Lu L, Malecka-Panas E, Mambrini A, Mohelnikova-Duchonova B, Neoptolemos JP, Oberg AL, Orlow I, Pasquali C, Pezzilli R, Rizzato C, Saldia A, Scarpa A, Stolzenberg-Solomon RZ, Strobel O, Tavano F, Vashist YK, Vodicka P, Wolpin BM, Yu H, Petersen GM, Risch HA, Klein AP. Common variation at 2p13.3, 3q29, 7p13 and 17q25.1 associated with susceptibility to pancreatic cancer. Nat Genet 2015;47(8)911-6. PMCID: PMC4520746.

Lawrenson K, Li Q, Kar S, Seo J-H, Tyrer J, Spindler TJ, Lee J, Chen Y, Karst A, Drapkin R, Aben KKH, Anton-Culver H, Antonenkova N, Australian Ovarian Cancer Study Group, Baker H, Bandera EV, Bean Y, Beckmann MW, Berchuck A, Bisogna M, Bjorge L, Bogdanova N, Brinton LA, Brooks-Wilson A, Bruinsma F, Butzow R, Campbell IG, Carty K, Chang-Claude J, Chenevix-Trench G, Chen A, Chen Z, Cook LS, Cramer DW, Cunningham JM, Cybulski C, Dansonka-Mieszkowska A, Dennis J, Dicks E, Doherty JA, Dörk T, du Bois A, Dürst M, Eccles D, Easton DT, Edwards RP, Eilber U, Ekici AB, Fasching PA, Fridley BL, Gao Y-T, Gentry-Maharaj A, Giles GG, Glasspool R, Goode EL, Goodman MT, Grownwald J, Harrington P, Harter P, Hasmad HN, Hein A, Heitz F, Hildebrandt MAT, Hillemanns P, Hogdall E, Hogdall C, Hosono S, Iversen ES, Jakubowska A, James P, Jensen A, Ji B-T, Karlan BY, Kjaer SK, Kelemen LE, Kellar M, Kelley JL, Kiemeney LA, Krakstad C, Kupryjanczyk J, Lambrechts D, Lambrechts S, Le ND, Lee AW, Lele S, Leminen A, Lester J, Levine DA, Liang D, Lissowska J, Lu K, Lubinski J, Lundvall L, Massuger LFAG, Matsuo K, McGuire V, McLaughlin JR, Nevanlinna H, McNeish I, Menon U, Modugno F, Moysich KB, Narod SA, Nedergaard L, Ness RB, Noor Azmi MA, Odunsi K, Olson SH, Orlow I, Orsulic S, Weber RP,

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Pearce CL, Pejovic T, Pelttari LM, Permuth-Wey J, Phelan CM, Pike MC, Poole EM, Ramus SJ, Risch HA, Rosen B, Rossing MA, Rothstein JH, Rudolph A, Runnebaum IB, Rzepecka IK, Salvesen HB, Schildkraut JM, Schwaab I, Sellers TA, Shu X-O, Shvetsov YB, Siddiqui N, Sieh W, Song H, Southey MC, Sucheston L, Tangen IL, Teo S-H, Terry KL, Thompson PJ, Timorek A, Tsai Y-Y, Tworoger SS, van Altena AM, Van Nieuwenhuysen E, Vergote I, Vierkant RA, Wang-Gohrke S, Walsh C, Wentzensen N, Whittemore AS, Wicklund KG, Wilkens LR, WooY-L, Wu X, Wu AH, Yang H, Zheng W, Ziogas A, Monteiro A, Pharoah PD, Gayther SA, Freedman ML. Cis-eQTL analysis and functional validation of candidate susceptibility genes for high-grade serous ovarian cancer. Nat Commun 2015;6:8234. PMCID: PMC4580986.

Kelemen LE, Lawrenson K, Tyrer J, Li Q, Lee JM, Seo J-H, Phelan CM, Beesley J, Chen X, Spindler TJ, Aben KKH, Anton-Culver H, Antonenkova N, Australian Ovarian Cancer Study Group, Baker H, Bandera EV, Bean Y, Beckmann MW, Bisogna M, Bjorge L, Bogdanova N,Brinton LA, Brooks-Wilson A, Bruinsma F, Butzow R, Campbell IG, Carty K, Chang-Claude J, Chen YA, Chen Z, Cook LS, Cramer DW, Cunningham JM, Cybulski C, Dansonka-Mieszkowska A, Dennis J, Dicks E, Doherty JA, Dörk T, du Bois A, Eccles D, Easton DT, Edwards RP, Eilber U, Ekici AB, Engelholm SA, Fasching PA, Fridley BL, Gao Y-T, Gentry-Maharaj A, Giles GG, Glasspool R, Goode EL, Goodman MT, Grownwald J, Harrington P, Harter P, Hasmad HN, Hein A, Heitz F, Hildebrandt MAT, Hillemanns P, Hogdall E, Hogdall C, Hosono S, Iversen ES, Jakubowska A, Jensen A, Ji B-T, Karlan BY, Kellar M, Kelley JL, Kiemeney LA, Krakstad C, Kjaer SK, Kupryjanczyk J, Lambrechts D, Lambrechts S, Le ND, Lee AW, Lele S, Leminen A, Lester J, Levine DA, Liang D, Lissowska J, Lu K, Lubinski J, Lundvall L, Massuger LFAG, Matsuo K, McGuire V, McLaughlin JR, McNeish I, Menon U, Modugno F, Moes-Sosnowska J, Moysich KB, Narod SA, Nedergaard L, Ness RB, Nevanlinna H, Noor Azmi MA, Odunsi K, Olson SH, Orlow I, Orsulic S, Weber RP, Paul J, Pearce CL,Pejovic T, Pelttari LM, Permuth-Wey J, Pike MC, Poole EM, Ramus SJ, Risch HA, Rosen B, Rossing MA, Rothstein JH, Rudolph A, Runnebaum IB, Rzepecka IK, Salvesen HB, Schildkraut JM, Schwaab I, Shu X-O, Shvetsov YB, Siddiqui N, Sieh W, Song H, Southey MC, Sucheston L, Tangen IL, Teo S-H, Terry KL, Thompson PJ, Tworoger SS, van Altena AM, Van Nieuwenhuysen E, Vergote I, Vierkant RA, Wang-Gohrke S, Walsh C, Wentzensen N, Whittemore AS, Wicklund KG, Wilkens LR, Wlodzimierz S, Woo Y-L, Wu X, Wu AH, Yang H, Zheng W, Ziogas A, Sellers TA, Freedman ML, Chenevix-Trench G, Pharoah PD, Gayther SA, Berchuck A, Ovarian Cancer Association Consortium. Genome-wide significant risk associations for mucinous ovarian carcinoma. Nat Genet 2015;47(8):888-97. PMCID: PMC4520768.

Petrick JL, Steck SE, Bradshaw PT, Trivers KF, Abrahamson PE, Engel LS, He K, Chow W-H, Mayne ST, Risch HA, Vaughan TL, Gammon MD. Dietary intake of flavonoids and oesophageal and gastric cancer: incidence and survival in the United States of America (USA). Br J Cancer 2015;112():1291-300. PMCID: PMC Journal in Process.

Yang HP, Cook LS, Weiderpass E, Adami H-O, Anderson KE, Cai H, Cerhan JR, Clendenen TV, Felix AS, Friedenreich CM, Garcia-Closas M, Goodman MT, Liang X, Lissowska J, Lu L, Magliocco AM, McCann SE, Moysich KB, Olson SH, Petruzella S, Pike MC, Polidoro S, Ricceri F, Risch HA, Sacerdote C, Setiawan VW, Shu XO, Spurdle AB, Trabert B, Webb PM, Wentzensen N, Xiang Y-B, Xu Y, Yu H, Zeleniuch-Jacquotte A, Brinton LA. Infertility and incident endometrial cancer risk: a pooled analysis from the epidemiology of endometrial cancer consortium (E2C2). Br J Cancer 2015;112(7):925-33. PMCID: PMC4453954.

Kuchenbaecker KB, Ramus SJ, Tyrer J, Lee A, Shen H, Beesley J, Lawrenson K, McGuffog L, Healey S, Lee JM, Spindler TJ, Lin YG, Pejovic T, Bean Y, Li Q, Coetzee S, Hazelett D, Miron

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A, Southey M, Terry MB, Goldgar DE, Buys SS, Janavicius R, Dorfling CM, van Rensburg EJ, Neuhausen SL, Ding YC, Hansen TVO, Jønson L, Gerdes A-M, Ejlertsen B, Barrowdale D, Dennis J, Benitez J, Osorio A, Garcia MJ, Komenaka I, Weitzel JN, Ganschow P, Peterlongo P, Bernard L, Viel A, Bonanni B, Peissel B, Manoukian S, Radice P, Papi L, Ottini L, Fostira F, Konstantopoulou I, Garber J, Frost D, Perkins J, Platte R, Ellis S, EMBRACE, Godwin AK, Schmutzler RK, Meindl A, Engel C, Sutter C, Sinilnikova OM, GEMO Study Collaborators, Damiola F, Mazoyer S, Stoppa-Lyonnet D, Claes K, Leeneer KD, Kirk J, Rodriguez GC, Piedmonte M, O'Malley DM, de la Hoya M, Caldes T, Aittomäki K, Nevanlinna H, Collée JM, Rookus MA, Oosterwijk JC, Breast Cancer Family Registry, Tihomirova L, Tung N, Hamann U, Isaccs C, Tischkowitz M, Imyanitov EN, Caligo MA, Campbell I, Hogervorst FBL, HEBON, Olah E, Diez O, Blanco I, Brunet J, Lazaro C, Pujana MA, Jakubowska A, Gronwald J, Lubinski J, Sukiennicki G, Barkardottir RB, Plante M, Simard J, Soucy P, Montagna M, Tognazzo S, Teixeira MR, KConFab Investigators, Pankratz VS, Wang X, Lindor N, Szabo CI, Kauff N, Vijai J, Aghajanian CA, Pfeiler G, Berger A, Singer CF, Tea M-K, Phelan CM, Greene MH, Mai PL, Rennert G, Mulligan AM, Tchatchou S, Andrulis IL, Glendon G, Toland AE, Jensen UB, Kruse TA, Thomassen M, Bojesen A, Zidan J, Friedman E, Laitman Y, Soller M, Liljegren A, Arver B, Einbeigi Z, Stenmark-Askmalm M, Olopade OI, Nussbaum RL, Rebbeck TR, Nathanson KL, Domchek SM, Lu KH, Karlan BY, Walsh C, Lester J, Australian Cancer Study (Ovarian Cancer), Australian Ovarian Cancer Study Group, Hein A, Ekici AB, Beckmann MW, Fasching PA, Lambrechts D, Van Nieuwenhuysen E, Vergote I, Lambrechts S, Dicks E, Doherty JA, Wicklund KG, Rossing MA, Rudolph A, Chang-Claude J, Wang-Gohrke S, Eilber U, Moysich KB, Odunsi K, Sucheston L, Lele S, Wilkens LR, Goodman MT, Thompson PJ, Shvetsov YB, Runnebaum IB, Dürst M, Hillemanns P, Dörk T, Antonenkova N, Bogdanova N, Leminen A, Pelttari LM, Butzow R, Modugno F, Kelley JL, Edwards RP, Ness RB, du Bois A, Heitz F, Schwaab I, Harter P, Matsuo K, Hosono S, Orsulic S, Jensen A, Kruger Kjaer S, Hogdall E, Hasmad HN, Noor Azmi MA, Teo S-H, Woo Y-L, Fridley BL, Goode EL, Cunningham JM, Vierkant RA, Bruinsma F, Giles GG, Liang D, Hildebrandt MAT, Wu X, Levine DA, Bisogna M, Berchuck A, Iversen ES, Schildkraut JM, Concannon P, Weber RP, Cramer DW, Terry KL, Poole EM, Tworoger SS, Bandera EV, Orlow I, Olson SH, Krakstad C, Salvesen HB, Tangen IL, Bjorge L, van Altena AM, Aben KKH, Kiemeney LA, G. LFA, Kellar M, Brooks-Wilson A, Kelemen LE, Cook LS, Le ND, Cybulski C, Yang H, Lissowska J, Brinton LA, Wentzensen N, Hogdall C, Lundvall L, Nedergaard L, Baker H, Song H, Eccles D, McNeish I, Paul J, Carty K, Siddiqui N, Glasspool R, Whittemore AS, Rothstein JH, McGuire V, Sieh W, Ji B-T, Zheng W, Shu X-O, Gao Y-T, Rosen B, Risch HA, McLaughlin JR, Narod SA, Monteiro AN, Chen A, Lin H-Y, Permuth-Wey J, Sellers TA, Tsai Y-Y, Chen Z, Ziogas A, Anton-Culver H, Gentry-Maharaj A, Menon U, Harrington P, Lee AW, Wu AH, Pearce CL, Coetzee G, Pike MC, Dansonka-Mieszkowska A, Timorek A, Rzepecka IK, Kupryjanczyk J, Freedman M, Noushmehr H, Easton DF, Offit K, Couch FJ, Gayther S, Pharoah PDP, Antoniou AC, Chenevix-Trench G on behalf of the Consortium of Investigators of Modifiers of BRCA1 and BRCA2. Identification of six new susceptibility loci for invasive epithelial ovarian cancer. Nat Genet 2015;47(2):164-71. PMCID: PMC Journal in Process.

Xie G, Lu L, Qiu Y, Ni Q, Zhang W, Gao Y-T, Risch HA, Yu H, Jia W. Plasma metabolite markers for the detection of pancreatic cancer. J Proteome Res. 2015;14(2):1195-202.PMCID: PMC4324440.

Segev Y, Zhang S, Akbari MR, Sun P, Sellers TA, McLaughlin J, Risch HA, Rosen B, Shaw P, Schildkraut J, Narod SA, Pal T. Survival in women with ovarian cancer with and without microsatellite instability. Eur J Gynaecol Oncol 2015;36(6):681-4. *Not a result of NIH

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funding.Lu L, Katsaros D, Risch E, Deng Q, Biglia N, Picardo E, Mitidieri M, Risch HA, Yu H.

Associations of LIN-28B/let-7a/IGF-II axis haplotypes with disease survival in epithelial ovarian cancer. Am J Clin Exp Obstet Gynecol 2015;2(3)102-15. *Not a result of NIH funding.

Chornokur G, Lin H-Y, Tyrer JP, Jim HSL, Lawrenson K, Amankwah EK, Qu X, Denis J, Tsai Y-Y, Chen Z, Chen AY, Permuth-Wey J, Aben K, Anton-Culver H, Antonenkova N, Australian Cancer Study, Australian Ovarian Cancer Study, Bruinsma F, Baker H, Bandera E, Bean Y, Beckmann M, Bisogna M, Bjorge L, Bogdanova N, Brinton L, Brooks-Wilson A, Bunker C, Butzow R, Campbell I, Carty K, Chang-Claude J, Concannon P, Cook LS, Cramer DW, Cunnigham JM, Cybulski C, Dansonka-Mieszkowska A, du Bois A, Despierre E, Dicks E, Doherty JA, Dork T, Durst M, Easton D, Eccles D, Edwards RP, Ekici AB, Fasching PA, Fridley BL, Gao Y-T, Gentry-Maharaj A, Giles GG, Glasspool R, Goodman MT, Gronwald J, Harrington P, Harter P, Hein A, Heitz F, Hildebrandt MAT, Hillemanns P, Hogdall C, Hogdall E, Hosono S, Jakubowska A, Jensen A, Ji B-T, Karlan BY, Kelemen LE, Kellar M, Kiemeney L, Krakstad C, Kruger Kjaer S, Kupryjanczyk J, Lambrechts D, Lambrechts S, Le ND, Lee A, Lele S, Leminen A, Lester J, Levine DA, Liang D, Lim BK, Lissowska J, Lu K, Lubinski J, Lundvall L, Massuger LFAG, Matsuo K, Milne RL, McGuire V, McLaughlin JR, McNeish I, Menon U, Modugno F, Moysich KB, Nedergaard L, Ness RB, Nevanlinna H, Nickels S, Odunsi K, Olson SH, Orlow I, Orsulic S, Palmieri-Weber R, Paul J, Pearce CL, Pejovic T, Pelttari LM, Pike MC, Poole EM, Risch HA, Rosen B, Rossing MA, Rothstein JH, Rudolph A, Runnebaum I, Rzepecka I, Salvensen HB, Schernhammer E, Schwaab I, Shu X-O, Shvetsov YB, Siddiqui N, Sieh W, Song H, Southey MC, Sucheston L, Teo S-H, Terry KL, Thompson PJ, Thorbjornsen I, Timorek A, Tworoger SS, van Altena AM, Vierkant RA, Vergote I, Walsh C, Wang-Gohrke S, Webb P, Wentzensen N, Whittemore AS, Wicklund KG, Wilkens LR, Wu AH, Wu X, Wu Y-L, Yang H, Zheng W, Ziogas A, Zulkifli F, Berchuck A, Chenevix-Trench G, Iversen E, Schildkraut JM, Ramus SJ, Goode EL, Monteiro ANA, Gayther SA, Narod SA, Sellers TA, Pharoah PDP, Phelan CM. Common genetic variation in cellular transport genes and epithelial ovarian cancer (EOC) risk. PLoS One 2015;10(6):e0128106. PMCID: PMC4474865.

Zhao J, Wang J, Du J, Xu H, Zhang W, Ni Q-X, Yu H, Risch HA, Gao Y-T, Gao Y. Urinary prostaglandin E2 metabolite and pancreatic cancer risk: case-control study in urban Shanghai. PLoS One 2015;10(2):e0118004. PMCID: PMC4332509.

Arem H, Yu K, Xiong X, Moy K, Freedman ND, Mayne ST, Albanes D, Amundadottir LT, Arslan AA, Austin M, Bamlet WR, Beane-Freeman L, Bracci P, Canzian F, Chanock SJ, Cotterchio M, Duell EJ, Gallinger S, Giles GG, Goggins M, Goodman PJ, Hartge P, Hassan M, Helzlsouer K, Henderson B, Holly EA, Hoover R, Jacobs EJ, Kamineni A, Klein A, Klein E, Kolonel LN, Li D, Malats N, Männistö S, McCullough ML, Olson SH, Orlow I, Peters U, Petersen GM, Porta M, Severi G, Shu X-O, Van Den Eeden S, Visvanathan K, White E, Yu H, Zeleniuch-Jacquotte A, Zheng W, Tobias GS, Maeder D, Brotzman M, Risch H, Sampson JN, Stolzenberg-Solomon RZ. Vitamin D metabolic pathway genes and pancreatic cancer risk. PLoS One 2015;10(3):e0117574. PMCID: PMC4370655.

Buas MF, Onstad L, Levine DM, Risch HA, Chow W-H, Liu G, Fitzgerald RC, Bernstein L, Ye W, Bird NC, Romero Y, Casson AG, Corley DA, Shaheen NJ, Wu AH, Gammon MD, Reid BJ, Hardie LJ, Peters U, Whiteman DC, Vaughan TL. MiRNA-related SNPs and risk of esophageal adenocarcinoma and Barrett’s Esophagus: Post genome-wide association analysis in

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the BEACON consortium. PLoS One 2015;10(6):e0128617. PMCID: PMC4454432.Shen Y, Katsaros D, Loo L, Hernandez BY, Chong C, Canuto EM, Biglia N, Lu L, Risch H, Chu

W-M, Yu H. Prognostic and predictive values of long non-coding RNA LINC00472 in breast cancer. Oncotarget 2015;6(11):8579-92. *Not a result of NIH funding.

Sampson J, Wheeler WA, Yeager M, Panagiotou O, Wang Z, Berndt SI, Lan Q, Abnet CC, Amundadottir LT, Figueroa JD, Landi MT, Mirabello L, Savage SA, Taylor PR, De Vivo I, McGlynn KA, Purdue MP, Rajaraman P, Adami H-O, Ahlbom A, Albanes D, Amary MF, An S-J, Andersson U, Andriole G Jr, Andrulis IL, Angelucci E, Ansell SM, Arici C, Armstrong BK, Arslan AA, Austin MA, Baris D, Barkauskas DA, Bassig BA, Becker N, Benavente Y, Benhamou S, Berg C, Van Den Berg D, Bertrand KA, Birmann BM, Black A, Boeing H, Boffetta P, Boutron-Ruault M-C, Bracci PM, Brinton L, Brooks-Wilson AR, Bueno-de-Mesquita HB, Burdett L, Buring J, Cai Q, Cancel-Tassin G, Canzian F, Carrato A, Carreon T, Carta A, Chan JKC, Chang ET, Chang G-C, Chang I-S, Chang J, Chang-Claude J, Chen C-J, Chen C-Y, Chen C, Chen C-H, Chen C, Chen H, Chen K, Chen K-Y, Chen K-C, Chen Y, Chen Y-H, Chen Y-S, Chen Y-M, Chien L-H, Chirlaque M-D, Choi JE, Choi YY, Chow W-H, Chung CC, Clavel J, Clavel-Chapelon F, Cocco P, Colt JS, Comperat E, Conde L, Connors JM, Conti D, Cortessis VK, Cotterchio M, Cozen W, Crouch S, Crous-Bou M, Cussenot O, Davis FG, Dawsey SM, Ding T, Diver WR, Dorronsoro M, Dossus L, Duell EJ, Ennas MG, Erickson RL, Feychting M, Flanagan AM, Foretova L, Fraumeni JF Jr, Freedman ND, Freeman LEB, Fuchs C, Gago-Dominguez M, Gallinger S, Gao Y-T, Gapstur SM, Garcia-Closas M, García-Closas R, Gascoyne RD, Gastier-Foster J, Gaudet MM, Gaziano JM, Giffen C, Giles GG, Giovannucci E, Glimelius B, Goggins M, Gokgoz N, Goldstein AM, Gorlick R, Gross M, Grubb R III, Gu J, Guan P, Gunter M, Guo H, Habermann TM, Haiman CA, Halai D, Hallmans G, Hassan M, Hattinger C, He Q, He X, Helzlsouer K, Henderson B, Henriksson R, Hjalgrim H, Hoffman-Bolton J, Hohensee C, Holford TR, Holly EA, Hong Y-C, Hoover RN, Horn-Ross PL, Hosain GM, Hosgood HD III, Hsiao C-F, Hu N, Hu W, Hu Z, Huang M-S, Huerta J-M, Hung J-Y, Hutchinson A, Inskip PD, Jackson RD, Jacobs EJ, Jenab M, Jeon H-S, Ji B-T, Jin G, Jin L, Johansen C, Johnson A, Jung YJ, Kaaks R, Kamineni A, Kane E, Kang CH, Karagas MR, Kelly RS, Khaw K-T, Kim C, Kim HN, Kim JH, Kim JS, Kim YH, Kim YT, Kim Y-C, Kitahara CM, Klein AP, Klein RJ, Kogevinas M, Kohno T, Kolonel LN, Kooperberg C, Kricker A, Krogh V, Kunitoh H, Kurtz RC, Kweon S-S, LaCroix A, Lawrence C, Lecanda F, Lee VHF, Li D, Li H, Li J, Li Y-J, Li Y, Liao LM, Liebow M, Lightfoot T, Lim W-Y, Lin C-C, Lin D, Lindstrom S, Linet MS, Link BK, Liu C, Liu J, Liu L, Ljungberg B, Lloreta J, Lollo SD, Lu D, Lund E, Malats N, Mannisto S, Le Marchand L, Marina N, Masala G, Mastrangelo G, Matsuo K, Maynadie M, McKay J, McKean-Cowdin R, Melbye M, Melin BS, Michaud DS, Mitsudomi T, Monnereau A, Montalvan R, Moore LE, Mortensen LM, Nieters A, North KE, Novak AJ, Oberg AL, Offit K, Oh I-J, Olson SH, Palli D, Pao W, Park IK, Park JY, Park KH, Patel AV, Patiño-Garcia A, Pavanello S, Peeters PHM, Perng R-P, Peters U, Petersen GM, Picci P, Pike MC, Porru S, Prescott J, Prokunina-Olsson L, Qian B, Qiao Y-L, Rais M, Riboli E, Riby J, Risch HA, Rizzato C, Rodabough R, Roman E, De Roos AJ, Roupret M, Ruder AM, De Sanjose S, Scelo G, Schned A, Schumacher F, Schwartz K, Schwenn M, Seow A, Serra C, Serra M, Sesso HD, Setiawan VW, Severi G, Severson RK, Shanafelt TD, Shen H, Shen W, Shin M-H, Shiraishi K, Shu X-O, Siddiq A, Sierrasesúmaga L, Sihoe ADL, Skibola CF, Smith A, Smith MT, Southey MC, Spinelli JJ, Staines A, Stampfer M, Stern MC, Stevens VL, Stolzenberg-Solomon RS, Su J, Su W-C, Sund M, Sung JS, Sung SW, Tan W, Tang W, Tardón A, Thomas D, Thompson CA, Thun MJ, Tinker LF, Tirabosco R, Tjønneland A, Travis RC, Trichopoulos D, Tsai F-Y, Tsai Y-H, Tucker M, Turner J, Vajdic CM, Vermeulen RCH,

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Villano DJ, Vineis P, Virtamo J, Visvanathan K, Wactawski-Wende J, Wang C, Wang C-L, Wang J-C, Wang J, Wei F, Weiderpass E, Weiner GJ, Weinstein S, Wentzensen N, White E, Witzig TE, Wolpin BM, Wong MP, Wu C, Wu G, Wu J, Wu T, Wu W, Wu X, Wu Y-L, Wunder J, Xiang Y-B, Xu J, Xu P, Yang P-C, Yang T-Y, Ye Y, Yin Z, Yokota J, Yoon H-I, Yu C-J, Yu H, Yu K, Yuan J-M, Zelenetz A, Zeleniuch-Jacquotte A, Zhang X-C, Zhang Y, Zhao X, Zhao Z, Zheng H, Zheng T, Zheng W, Zhou B, Zhu M, Zucca M, Boca SM, Cerhan JR, Ferri GM, Hartge P, Hsiung CA, Magnani C, Miligi L, Morton LM, Smedby KE, Teras LR, Vijai J, Wang SS, Brennan P, Caporaso NE, Hunter DJ, Kraft P, Rothman N, Silverman DT, Slager SL, Chanock SJ, Chatterjee N. Analysis of heritability and shared heritability based on genome-wide association studies for thirteen cancer types. J Natl Cancer Inst2015;107(12):djv279. PMCID: PMC Journal in Process.

Palles C, Chegwidden L, Li X, Findlay JM, Farnham G, Giner FC, Peppelenbosch MP, Kovac M, Adams CL, Prenen H, Briggs S, Harrison R, Sanders S, MacDonald D, Haigh C, Tucker A, Love S, Nanji M, deCaestecker J, Ferry D, Rathbone B, Hapeshi J, Barr H, Zietek B, Maroo N, Gay L, Underwood T, Boulter L, McMurtry H, Monk D, Patel P, Ragunath K, Al Dulaimi D, Murray I, Koss K, Veitch A, Trudgill N, Nwokolo C, Rembacken B, Atherfold P, Green E, Ang Y, Kuipers EJ, Chow W, Paterson S, Kadri S, Beales I, Grimley C, Mullins P, Beckett C, Farrant M, Dixon A, Kelly S, Johnson M, Wajed S, Dhar A, Sawyer E, Roylance R, Onstad L, Gammon MD, Corley DA, Shaheen NJ, Bird NC, Hardie LJ, Reid BJ, Ye W, Liu G, Romero Y, Bernstein L, Wu AH, Casson AG, Fitzgerald R, Whiteman DC, Risch HA, Levine DM, Vaughan TL, Verhaar AP, van den Brande J, Toxopeus EL, Spaander MC, Wijnhoven BPL, van der Laan LJ, Krishnadath K, Wijmenga C, Trynka G, McManus R, Reynolds JV, O’Sullivan J, MacMathuna P, McGarrigle SA, Kelleher D, Vermeire S, Cleynen I, Bisschops R, Tomlinson I, Jankowski J. Polymorphisms near TBX5 and GDF7 are associated with increased risk for Barrett’s Esophagus. Gastroenterology 2015;148(2):367-78. PMCID: PMC4315134.

2014Lu Y, Ek WE, Whiteman D, Vaughan TL, Spurdle AB, Easton DF, Pharoah PD, Thompson DJ,

Dunning AM, Hayward NK, Chenevix-Trench G, Q-MEGA and AMFS Investigators, ANECS-SEARCH, UKOPS-SEARCH, BEACON Consortium, Macgregor S. Most common ‘sporadic’ cancers have a significant germline genetic component. Hum Molec Genet 2014;23(22):6112-8. PMCID: PMC4271103.

Thrift AP, Risch HA, Onstad L, Shaheen NJ, Casson AG, Bernstein L, Corley DA, Levine DM, Chow W-H, Reid BJ, Romero Y, Hardie LJ, Liu G, Wu AH, Bird NC, Gammon MD, Ye W, Whiteman DC, Vaughan TL. Risk of esophageal adenocarcinoma decreases with height, based on consortium analysis and confirmed by Mendelian randomization. Clin Gastroenterol Hepatol 2014;12(10):1667-76. PMCID: PMC4130803.

Neale RE, Clark P, Fawcett J, Fritschi L, Nagler BN, Risch H, Walters RJ, Crawford WJ, Webb PM, Whiteman DC, Buchanan DD. Association between hypermethylation of DNA repetitive elements in white blood cell DNA and pancreatic cancer. Cancer Epidemiol 2014;38(5):576-82. *Not a result of NIH funding.

Segev Y, Pal T, Rosen B, McLaughlin JR, Sellers TA, Risch HA, Zhang S, Sun P, Narod SA, Schildkraut J. Risk factors for ovarian cancers with and without microsatellite instability. Int J Gynecol Cancer 2014;24(4):664-9. PMCID: PMC Journal in Process.

Wolpin BM, Rizzato C, Kraft P, Kooperberg C, Petersen GM, Wang Z, Arslan AA, Beane-Freeman L, Bracci PM, Buring J, Canzian F, Duell EJ, Gallinger S, Giles GG, Goodman GE, Goodman PJ, Jacobs EJ, Kamineni A, Klein AP, Kolonel LN, Kulke MH, Li D, Malats N,

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Olson SH, Risch HA, Sesso HD, Visvanathan K, White E, Zheng W, Abnet CC, Albanes D, Andriotti G, Austin MA, Barfield R, Basso D, Berndt SI, Boutron-Ruault M-C, Brotzman M, Büchler MW, Bueno-de-Mesquita HB, Bugert P, Burdette L, Campa D, Caporaso NE, Capurso G, Chung C, Cotterchio M, Costello E, Elena J, Funel N, Gaziano JM, Giese N, Giovannucci EL, Goggins M, Gorman MJ, Gross M, Haiman CA, Hassan M, Helzlsouer K, Henderson BE, Holly EA, Hu N, Hunter DJ, Innocenti F, Jenab M, Kaaks R, Key TJ, Khaw K-T, Klein EA, Kogevinas M, Kupcinskas J, Kurtz RC, LaCroix A, Landi MT, Landi S, Le Marchand L, Mambrini A, Mannisto S, Milne RL, Nakamura Y, Oberg AL, Owzar K, Panico S, Patel AV, Peeters PHM, Peters U, Piepoli A, Porta M, Real FX, Riboli E, Rothman N, Scarpa A, Shu X-O, Silverman DT, Soucek P, Sund M, Talar-Wojnarowska R, Taylor PR, Theodoropoulos GE, Thornquist M, Tjønneland A, Tobias GS, Trichopoulos D, Vodicka P, Wactawski-Wende J, Wentzensen N, Wu C, Yu H, Yu K, Zeleniuch-Jacquotte A, Hoover R, Hartge P, Fuchs C,Chanock S, Stolzenberg-Solomon RS, Amundadottir L. Genome-wide association study identifies multiple susceptibility loci for pancreatic cancer. Nat Genet 2014;46(9):994-1000.PMCID: PMC4191666.

Finch A, Bacopoulos S, Rosen B, Fan I, Bradley L, Risch H, McLaughlin JR, Lerner-Ellis J, Narod SA. Preventing ovarian cancer through genetic testing: a population-based study. Clin Genet2014;86(5):496-9. *NIH funding pre-dates mandate.

Kelemen LE, Terry KL, Goodman MT, Webb PM, Bandera EV, McGuire V, Rossing MA, Wang Q, Dicks E, Tyrer JP, Song H, Kupryjanczyk J, Dansonka-Mieszkowska A, Plisiecka-Halasa J, Timorek A, Menon U, Gentry-Maharaj A, Gayther SA, Ramus SJ, Narod SA, Risch HA,McLaughlin JR, Siddiqui N, Glasspool R, Paul J, Carty K, Gronwald J, Lubi ski J, Jakubowska A, Cybulski C, Kiemeney LA, Massuger LFAG, van Altena AM, Aben KKH, Olson SH, Orlow I, Cramer DW, Levine DA, Bisogna M, Giles GG, Southey MC, Bruinsma F, Krüger Kjær S, Høgdall E, Jensen A, Høgdall CK, Lundvall L, Engelholm S-A, Heitz F, du Bois A, Harter P, Schwaab I, Butzow R, Nevanlinna H, Pelttari LM, Leminen A, Thompson PJ, Lurie G, Wilkens LR, Lambrechts D, Van Nieuwenhuysen E, Lambrechts S, Vergote I, Beesley J, AOCS Study Group/ACS Investigators, Fasching PA, Beckmann MW, Hein A, Ekici AB, Doherty JA, Wu AH, Pearce CL, Pike MC, Stram D, Chang-Claude J, Rudolph A, Dörk T, Dürst M, Hillemanns P, Runnebaum IB, Bogdanova N, Antonenkova N, Odunsi K, Edwards RP, Modugno F, Ness RB, Karlan BY, Walsh C, Lester J, Orsulic S, Fridley BL, Vierkant RA, Cunningham JM, Wu X, Lu K, Liang D, Hildebrandt MAT, Weber RP, Iversen ES, Tworoger SS, Poole EM, Salvesen HB, Krakstad C, Bjorge L, Tangen IL, Pejovic T, Bean Y, Kellar M, Wentzensen N, Brinton LA, Lissowska J, Garcia-Closas M, Campbell IG, Eccles D, Whittemore AS, Sieh W, Rothstein JH, Anton-Culver H, Ziogas A, Phelan CM, Moysich KB, Goode EL, Schildkraut JM, Berchuck A, Pharoah PDP, Sellers TA, Brooks-Wilson A, Cook LS, Le ND, on behalf of the Ovarian Cancer Association Consortium. Consortium analysis of gene and gene-folate interactions in purine and pyrimidine metabolism pathways with ovarian carcinoma risk. Mol Nutr Food Res 2014;58(10):2023-5. PMCID: PMC4197821.

Setiawan VW, Schumacher F, Prescott J, Haessler J, Malinowski J, Wentzensen N, Yang H, Chanock S, Brinton L, Hartge P, Lissowska J, Park SL, Cheng I, Bush WS, Crawford DC, Ursin G, Horn-Ross P, Bernstein L, Lu L, Risch H, Yu H, Sakoda LC, Doherty J, Chen C, Jackson R, Yasmeen S, Cote M, Kocarnik JM, Peters U, Kraft P, De Vivo I, Haiman CA, Kooperberg C, Le Marchand L. Cross-cancer pleiotropic analysis of endometrial cancer: PAGE and E2C2 Consortia. Carcinogenesis 2014;35(9):2068-73. PMCID:4146418.

Lawrenson K, Iversen ES, Tyrer J, Weber RP, Concannon P, Hazelett DJ, Li Q, Marks JR, Berchuck A, Lee JM, Aben KKH, Anton-Culver H, Antonenkova N, Australian Cancer Study

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Wang Z, Zhu B, Zhang M, Parikh H, Jia J, Chung CC, Sampson JN, Hoskins JW, Hutchinson A, Burdette L, Ibrahim A, Hautman C, Raj PS, Abnet CC, Adjei AA, Ahlbom A, Albanes D, Allen NE, Ambrosone CB, Aldrich M, Amiano P, Amos C, Andersson U, Andriole G Jr, Andrulis IL, Arici C, Arslan AA, Austin MA, Baris D, Barkauskas DA, Bassig BA, Beane Freeman LE, Berg CD, Berndt SI, Bertazzi PA, Biritwum RB, Black A, Blot W, Boeing H, Boffetta P, Bolton K, Boutron-Ruault M-C, Bracci PM, Brennan P, Brinton LA, Brotzman M, Bueno-de-Mesquita HB, Buring JE, Butler MA, Cai Q, Cancel-Tassin G, Canzian F, Cao G, Caporaso NE, Carrato A, Carreon T, Carta A, Chang G-C, Chang I-S, Chang-Claude J, Che X, Chen C-J, Chen C-Y, Chen C-H, Chen C, Chen K-Y, Chen Y-M, Chokkalingam AP, Chu LW, Clavel-Chapelon F, Colditz GA, Colt JS, Conti D, Cook MB, Cortessis VK, Crawford ED, Cussenot O, Davis FG, De Vivo I, Deng X, Ding T, Dinney CP, Di Stefano AL, Diver WR, Duell EJ, Elena JW, Fan J-H, Feigelson HS, Feychting M, Figueroa JD, Flanagan AM, Fraumeni JF Jr, Freedman ND, Fridley BL, Fuchs CS, Gago-Dominguez M, Gallinger S, Gao Y-T, Gapstur SM, Garcia-Closas M, Garcia-Closas R, Gastier-Foster JM, Gaziano JM, Gerhard DS, Giffen CA, Giles GG, Gillanders EM, Giovannucci EL, Goggins M, Gokgoz N, Goldstein AM,Gonzalez C, Gorlick R, Greene MH, Gross M, Grossman HB, Grubb R III, Gu J, Guan P, Haiman CA, Hallmans G, Hankinson SE, Harris CC, Hartge P, Hattinger C, Hayes RB, He Q, Helman L, Henderson BE, Henriksson R, Hoffman-Bolton J, Hohensee C, Holly EA, Hong Y-C, Hoover RN, Hosgood HD III, Hsiao C-F, Hsing AW, Hsiung CA, Hu N, Hu W, Hu Z, Huang M-S, Hunter DJ, Inskip PD, Ito H, Jacobs EJ, Jacobs KB, Jenab M, Ji B-T, Johansen C, Johansson M, Johnson A, Kaaks R, Kamat AM, Kamineni A, Karagas M, Khanna C, Khaw K-T, Kim C, Kim I-S, Kim YH, Kim Y-C, Kim YT, Kang CH, Jung YJ, Kitahara CM, Klein AP, Klein R, Kogevinas M, Koh W-P, Kohno T, Kolonel LN, Kooperberg C, Kratz CP, Krogh V, Kunitoh H, Kurtz RC, Kurucu N, Lan Q, Lathrop M, Lau CC, Lecanda F, Lee K-M, Lee MP, Le Marchand L, Lerner SP, Li D, Liao LM, Lim W-Y, Lin D, Lin J, Lindstrom S, Linet MS,

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Lissowska J, Liu J, Ljungberg B, Lloreta J, Lu D, Ma J, Malats N, Mannisto S, Marina N, Mastrangelo G, Matsuo K, McGlynn KA, McKean-Cowdin R, McNeill LH, McWilliams RR, Melin BS, Meltzer PS, Mensah JE, Miao X, Michaud DS, Mondul AM, Moore LE, Muir K, Niwa S, Olson SH, Orr N, Panico S, Park JY, Patel AV, Patino-Garcia A, Pavanello S, Peeters PHM, Peplonska B, Peters U, Petersen GM, Picci P, Pike MC, Porru S, Prescott J, Pu X, Purdue MP, Qiao Y-L, Rajaraman P, Riboli E, Risch HA, Rodabough RJ, Rothman N, Ruder AM, Ryu J-S, Sanson M, Schned A, Schumacher FR, Schwartz AG, Schwartz KL, Schwenn M, Scotlandi K, Seow A, Serra C, Serra M, Sesso HD, Severi G, Shen H, Shen M, Shete S, Shiraishi K, Shu X-O, Siddiq A, Sierrasesumaga L, Sierri S, Sihoe ADL, Silverman DT, Simon M, Southey MC, Spector L, Spitz M, Stampfer M, Stattin P, Stern MC, Stevens VL, Stolzenberg-Solomon RZ, Stram DO, Strom SS, Su W-C, Sund M, Sung SW, Swerdlow A, Tan W, Tanaka H, Tang W, Tang Z-Z, Tardon A, Tay E, Taylor PR, Tettey Y, Thomas DM, Tirabosco R, Tjonneland A, Tobias GS, Toro JR, Travis RC, Trichopoulos D, Troisi R, Truelove A, Tsai Y-H, Tucker MA, Tumino R, Van Den Berg D, Van Den Eeden SK, Vermeulen R, Vineis P, Visvanathan K, Vogel U, Wang C, Wang C, Wang J, Wang SS, Weiderpass E, Weinstein SJ, Wentzensen N, Wheeler W, White E, Wiencke JK, Wolk A, Wolpin BM, Wong MP, Wrensch M, Wu C, Wu T, Wu X, Wu Y-L, Wunder JS, Xiang Y-B, Xu J, Yang HP, Yang P-C, Yatabe Y, Ye Y, Yeboah ED, Yin Z, Ying C, Yu C-J, Yu K, Yuan J-M, Zanetti KA, Zeleniuch-Jacquotte A, Zheng W, Zhou B, Mirabello L, Savage SA, Kraft P, Chanock SJ, Yeager M, Landi MT, Shi J, Chatterjee N, Amundadottir LT. Imputation and subset based association analysis across different cancer types identifies multiple independent risk loci in the TERT-CLPTM1L region on chromosome 5p15.33. Hum Molec Genet 2014;23(24):6616-33. PMCID: PMC Journal in Process.

Cook MB, Corley DA, Murray LJ, Liao LM, Kamangar F, Ye W, Gammon MD, Risch HA,Casson AG, Freedman ND, Chow W-H, Wu AH, Bernstein L, Nyrén O, Pandeya N, Whiteman DC, Vaughan TL. Gastroesophageal reflux in relation to adenocarcinomas of the esophagus: A pooled analysis from the Barrett’s and Esophageal Adenocarcinoma Consortium (BEACON). PLoS One 2014;9(7):e103508. PMCID: PMC4116205.

Chen MM, Crous-Bou M, Setiawan VW, Prescott J, Olson SH, Wentzensen N, Black A, Brinton L, Chen C, Chen C, Cook LS, Doherty J, Friedenreich CM, Gaudet MM, Hankinson SE, Hartge P, Henderson BE, Horn-Ross PL, Hunter DJ, Le Marchand L, Liang X, Lissowska J, Lu L, Orlow I, Petruzella S, Pooler L, Rebbeck TR, Risch H, Sacerdote C, Schumacher F, Sheng X, Shu X-O, Weiss NS, Xia L, Van Den Berg D, Yang HP, Yu H, Chanock S, Haiman C, Kraft P, De Vivo I. Exome-wide association study of endometrial cancer in a multiethnic population. PLoS One 2014;9(5):e97045. PMCID: PMC4014590.

Tang H, Wei P, Duell EJ, Risch HA, Olson SH, Bueno-de-Mesquita HB, Gallinger S, Holly EA, Petersen G, Bracci PM, McWilliams RR, Jenab M, Riboli E, Tjønneland A, Boutron-Ruault MC, Kaaks R, Trichopoulos D, Panico S, Sund M, Peeters PHM, Khaw K-T, Amos CI, Li D. Axonal guidance signaling pathway interacting with smoking in modifying the risk of pancreatic cancer: A gene and pathway-based interaction analysis of GWAS data. Carcinogenesis 2014;35(5):1039-45. PMCID: PMC4004205.

Huang H, Ma X, Waagepetersen R, Holford T, Wang R, Risch H, Mueller L, Guan Y. A new estimation approach for combining epidemiological data from multiple sources. J Am Stat Assoc 2014;109(505):11-23. PMCID: PMC3964681.

Trabert B, Ness R, Lo-Ciganic W-H, Murphy M, Goode E, Poole E, Brinton L, Webb P, Nagle C, Jordan S, Risch H, Rossing MA, Doherty J, Goodman M, Lurie G, Krüger Kjær S, Høgdall E, Jensen A, Cramer D, Terry K, Vitonis A, Bandera E, Olson S, King M, Chandran U, Anton-

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Culver H, Ziogas A, Menon U, Gayther S, Ramus S, Gentry-Maharaj A, Wu A, Pearce C, Pike M, Berchuck A, Schildkraut J, Wentzensen N, on behalf of the Ovarian Cancer Association Consortium. Aspirin, non-aspirin nonsteroidal anti-inflammatory drug, and acetaminophen use and risk of invasive epithelial ovarian cancer: a pooled analysis in the Ovarian Cancer Association Consortium. J Natl Cancer Inst 2014;106(2):djt431. PMCID: PMC3898362.

Xu H-L, Cheng J-R, Zhang W, Wang J, Yu H, Ni Q-X, Risch HA, Gao Y-T. Re-evaluation of ABO gene polymorphisms detected in a genome-wide association study and risk of pancreatic ductal adenocarcinoma in a Chinese population. Chin J Cancer 2014;33(2):68-73. PMCID: PMC3884064.

Charbonneau B, Block MS, Bamlet WR, Vierkant RA, Kalli KR, Fogarty Z, Rider DN, Sellers TA, Tworoger SS, Poole E, Risch HA, Salvesen HB, Kiemeny LA, Baglietto L, Giles GG, Severi G, Trabert B, Wentzensen N, Chenevix-Trench G for AOCS/ACS group, Whittemore AS, Sieh W, Chang-Claude J, Bandera EV, Orlow I, Terry K, Goodman MT, Thompson PJ, Cook LS, Rossing M, Ness RB, Narod SA, Kupryjanczyk J, Lu K, Bützow R, Dork T, Pejovic T, Campbell I, Le ND, Bunker CH, Bogdanova N, Runnebaum IB, Eccles DM, Paul J, Wu AH, Gayther SA, Hogdall E, Heitz F, Kaye SB, Karlan BY, Anton-Culver H, Gronwald J, Hogdall CK, Lambrechts D, Fasching PA, Menon U, Schildkraut J, Pearce CL, Levine DA, Kruger Kjær S, Cramer D, Flanagan JM, Phelan CM, Brown R, Massuger LFAG, Song H, Doherty JA, Krakstad C, Liang D, Odunsi K, Berchuck A, Jensen A, Lubi ski J, Nevanlinna H, Bean YT, Lurie G, Ziogas A, Walsh C, Despierre E, Brinton L, Hein A, Rudolph A, Dansonka-Mieszkowska A, Olson SH, Harter P, Tyrer J, Vitonis AF, Brooks-Wilson A, Aben KK, Pike MC, Ramus SJ, Wik E, Cybulski C, Lin J, Sucheston L, Edwards R, McGuire V, Lester J, du Bois A, Lundvall L, Wang-Gohrke S, Szafron LM, Lambrechts S, Yang HP, Beckmann MW, Pelttari LM, van Altena AM, van den Berg D, Halle M, Gentry-Maharaj A, Schwaab I, Chandran U, Menkiszak J, Ekici AB, Wilkens LR, Leminen A, Modugno F, Friel G, Rothstein JH, Vergote I, Garcia-Closas M, Hildebrandt MAT, Sobiczewski P, Kelemen LE, Pharoah PDP, Moysich K, Knutson KL, Cunningham JM, Fridley BL, Goode EL. Risk of ovarian cancer and the NF- B pathway: Genetic association with IL1A and TNFSF10. Cancer Res 2014;74(3):852-61. PMCID: PMC3946482.

Earp MA, Kelemen LE, Magliocco AM, Swenerton KD, Chenevix-Trench G, Australian Cancer Study, Australian Ovarian Cancer Study Group, Lu Y, Hein A, Ekici AB, Beckmann MW, Fasching PA, Lambrechts D, Despierre E, Vergote I, Lambrechts S, Doherty JA, Rossing MA, Chang-Claude J, Rudolph A, Friel G, Moysich KB, Odunsi K, Sucheston L, Lurie G, Goodman MT, Carney ME, Thompson PJ, Runnebaum I, Dürst M, Hillemanns P, Dörk T, Antonenkova N, Bogdanova N, Leminen A, Nevanlinna H, Pelttari LM, Butzow R, Bunker CH, Modugno F, Edwards RP, Ness RB, du Bois A, Heitz F, Schwaab I, Harter P, Karlan BY, Walsh C, Lester J, Jensen A, Kjær SK, Høgdall CK, Høgdall E, Lundvall L, Sellers TA, Fridley BL, Goode EL, Cunningham JM, Vierkant RA, Giles GG, Baglietto L, Severi G, Southey MC, Liang D, Wu X, Lu K, Hildebrandt MA, Levine DA, Bisogna M, Schildkraut JM, Iversen ES, Palmieri Weber R, Berchuck A, Cramer DW, Terry KL, Poole EM, Tworoger SS, Bandera EV, Chandran U, Orlow I, Olson SH, Wik E, Salvesen HB, Bjorge L, Halle MK, van Altena AM, Aben KK, Kiemeney LA, Massuger LFAG, Pejovic T, Bean YT, Cybulski C, Gronwald J, Lubinski J, Wentzensen N, Brinton LA, Lissowska J, Garcia-Closas M, Dicks E, Dennis J, Easton DF, Song H, Tyrer JP, Pharoah PDP, Eccles D, Campbell IG, Whittemore AS, McGuire V, Sieh W, Rothstein JH, Flanagan JM, Paul J, Brown R, Phelan CM, Risch HA, McLaughlin JR, Narod SA, Ziogas A, Anton-Culver H, Gentry-Maharaj A, Menon U, Gayther SA, Ramus SJ, Wu AH, Pearce CL, Pike MC, Dansonka-Mieszkowska A, Rzepecka IK, Szafron LM, Kupryjanczyk J,

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Cook LS, Le ND, Brooks-Wilson A, on behalf of the Ovarian Cancer Association Consortium. Genome-wide association study of subtype-specific epithelial ovarian cancer risk alleles using pooled DNA. Hum Genet 2014;133(5):481-97. PMCID: PMC4063682.

Tang H, Wei P, Duell EJ, Risch HA, Olson SH, Bueno-de-Mesquita HB, Gallinger S, Holly EA, Petersen GM, Bracci PM, McWilliams RR, Jenab M, Riboli E, Tjønneland A, Boutron-Ruault MC, Kaaks R, Trichopoulos D, Panico S, Sund M, Peeters PHM, Khaw K-T, Amos CI, Li D. Genes-environment interactions in obesity- and diabetes-associated pancreatic cancer: A GWAS data analysis. Cancer Epidemiol Biomarkers Prev 2014;23(1):98-106. PMCID: PMC3947145.

De Vivo I, Prescott J, Setiawan VW, Olson SH, Wentzensen N, Australian National Endometrial Cancer Study Group, Attia J, Black A, Brinton L, Chen C, Chen C, Cook LS, Crous-Bou M, Doherty J, Dunning AM, Easton DF, Friedenreich CM, Garcia-Closas M, Gaudet MM, Haiman C, Hankinson SE, Hartge P, Henderson BE, Holliday E, Horn-Ross PL, Hunter DJ, Le Marchand L, Liang X, Lissowska J, Long J, Lu L, Magliocco AM, McEvoy M, O'Mara TA, Orlow I, Painter JN, Pooler L, Rastogi R, Rebbeck TR, Risch H, Sacerdote C, Schumacher F, Scott RJ, Sheng X, Shu X-O, Spurdle AB, Thompson D, VanDen Berg D, Weiss NS, Xia L, Xiang Y-B, Yang HP, Yu H, Zheng W, Chanock S, Kraft P. Genome.wide association study of endometrial cancer in E2C2. Hum Genet 2014;133(2):211-24. PMCID: PMC3898362.

Buas MF, Levine DM, Makar KW, Utsugi H, Onstad L, Li X, Galipeau PC, Shaheen NJ, Hardie LJ, Romero Y, Bernstein L, Gammon MD, Casson AG, Bird NC, Risch HA, Ye W, Liu G, Corley DA, Blount PL, Fitzgerald RC, Whiteman DC, Wu AH, Reid BJ, Vaughan TL. Integrative post-genome-wide association analysis of CDKN2A and TP53 SNPs and risk of esophageal adenocarcinoma. Carcinogenesis 2014; 35(12):2740-7. PMCID: PMC Journal in Process.

Thrift AP, Shaheen NJ, Gammon MD, Bernstein L, Reid BJ, Onstad L, Risch HA, Liu G, Bird NC, Wu AH, Corley DA, Romero Y, Chanock S, Chow W-H, Casson AG, Levine DM, Zhang R, Ek WE, MacGregor S, Ye W, Hardie LJ, Vaughan TL, Whiteman DC. Obesity and risk of esophageal adenocarcinoma and Barrett’s Esophagus: a Mendelian randomization study. J Natl Cancer Institute 2014;106(11):dju252. doi: 10.1093/jnci/dju252. PMCID: PMC4200028.

Streicher SA, Yu H, Lu L, Kidd MS, Risch HA. Case-control study of aspirin use and risk of pancreatic cancer. Cancer Epidemiol Biomarkers Prev 2014;23(7):1254-63. PMCID: PMC4091763.

Risch HA, Lu L, Kidd MS, Wang J, Zhang W, Ni Q, Gao Y-T, Yu H. Helicobacter pyloriseropositivities and risk of pancreatic carcinoma. Cancer Epidemiol Biomarkers Prev2014;23(1):172-8. PMCID: PMC3947155.

Schulte A, Pandeya N, Tran B, Fawcett J, Fritschi L, Risch HA, Webb PM, Whiteman DC, Neale RE, Queensland Pancreatic Cancer Study Group. Cigarette smoking and pancreatic cancer risk: more to the story than just pack-years. Eur J Cancer 2014;50(5):997-1003. . *Not a result of NIH funding.

Kotsopoulos J, Prescott J, De Vivo I, Fan I, McLaughlin J, Rosen B, Risch H, Sun P, Narod SA. Telomere length and mortality following a diagnosis of ovarian cancer. Cancer Epidemiol Biomarkers Prev 2014;23(11):2603-6. PMCID: PMC4221534.

Navarro Silvera SA, Mayne ST, Gammon MD, Vaughan TL, Chow W-H, Dubin JA, Dubrow R, Stanford JL, West AB, Rotterdam H, Blot WJ, Risch HA. Diet and lifestyle factors and risk of subtypes of esophageal and gastric cancer: classification tree analysis. Ann Epidemiol

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2014;24(1):50-7. PMCID: PMC4006990.2013

Pearce CL, Rossing MA, Lee AW, Ness R, Webb PM for Australian Cancer Study (Ovarian Cancer) and Australian Ovarian Cancer Study Group, Chenevix-Trench G, Jordan SM, Stram DA, Chang-Claude J, Hein R, Nickels S, Lurie G, Thompson PJ, Carney ME, Goodman MT, Moysich K, Hogdall E, Jensen A, Goode EL, Fridley BL, Cunningham JM, Vierkant RA, Weber RP, Ziogas A, Anton-Culver H, Gayther SA, Gentry-Maharaj A, Menon U, Ramus SJ, Brinton L, Wentzensen N, Lissowska J, Garcia-Closas M, Massuger LFAG, Kiemeney LALM, van Altena AM, Aben KKH, Berchuck A, Doherty JA, Iversen E, McGuire V, Moorman PG, Pharoah P, Pike MC, Risch H, Sieh W, Stram DO, Terry KL, Whittemore A, Wu AH, Schildkraut JM, Kjaer SK for the Ovarian Cancer Association Consortium. Combined and interactive effects of environmental and GWAS-identified risk factors in ovarian cancer. Cancer Epidemiol Biomarkers Prev 2013;22(5):880-90. PMCID: PMC3963289.

Leenders M, Bhattacharjee S, Vineis P, Stevens V, Bueno-de-Mesquita HB, Shu XO, Amundadottir L, Gross M, Tobias GS, Wactawski-Wende J, Arslan AA, Duell EJ, Fuchs CS, Gallinger S, Hartge P, Hoover RN, Holly EA, Jacobs EJ, Klein AP, Kooperberg C, Lacroix A, Li D, Mandelson MT, Olson SH, Petersen G, Risch HA, Yu K, Wolpin BM, Zheng W, Agalliu I, Albanes D, Boutron-Ruault MC, Bracci PM, Buring JE, Canzian F, Chang K, Chanock SJ, Cotterchio M, Gaziano JM, Giovanucci EL, Goggins M, Hallmans G, Hankinson SE, Hoffman-Bolton JA, Hunter DJ, Hutchinson A, Jacobs KB, Jenab M, Khaw KT, Kraft P, Krogh V, Kurtz RC, McWilliams RR, Mendelsohn JB, Patel AV, Rabe KG, Riboli E, Tjønneland A, Trichopoulos D, Virtamo J, Visvanathan K, Elena JW, Yu H, Zeleniuch-Jacquotte A, Stolzenberg-Solomon RZ. Polymorphisms in genes related to one-carbon metabolism are not related to pancreatic cancer in PanScan and PanC4. Cancer Causes Control 2013;24(3):595-602. PMCID: PMC4127987.

Ek WE, Levine DM, D'Amato M, Pedersen NL, Magnusson PKE, Bresso F, Onstad LE, Schmidt PT, Törnblom H, Nordenstedt H, Romero Y, Chow W-H, Murray LJ, Gammon MD, Liu G, Bernstein L, Casson AG, Risch HA, Shaheen NJ, Bird NC, Reid BJ, Corley DA, Hardie LJ, Ye W, Wu AH, Zucchelli M, Spector TD, Hysi P, Vaughan TL, Whiteman DC, MacGregor S. Germline genetic contributions to risk for esophageal adenocarcinoma, Barrett’s Esophagus and gastroesophageal reflux. J Natl Cancer Inst 2013;105(22):1711-8. PMCID: PMC3833931.

Arem H, Reedy J, Sampson J, Jiao L, Hollenbeck AR, Risch H, Mayne ST, Stolzenberg-Solomon RZ. The Healthy Eating Index-2005 and risk of pancreatic cancer in the NIH-AARP Study. J Natl Cancer Inst 2013;105(17):1298-305. PMCID: PMC3760780.

Arem H, Mayne ST, Sampson J, Risch H, Stolzenberg-Solomon RZ. Dietary fat intake and risk of pancreatic cancer in the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial. Ann Epidemiol 2013;23(9):571-5. PMCID: PMC3752990.

Terry KL, Karageorgi S, Shvetsov YB, Merritt MA, Lurie G, Thompson PJ, Carney ME, Weber RP, Akushevich L, Lo-Ciganic W-H, Cushing-Haugen K, Sieh W, Moysich K, Doherty JA, Nagle CM, Australian Cancer Study (Ovarian Cancer), Australian Ovarian Cancer Study Group, Berchuck A, Pearce CL, Pike M, Ness RB, Webb PM, Rossing MA, Schildkraut J, Risch H, Goodman MT, The Ovarian Cancer Association Consortium. Genital powder use and risk of ovarian cancer: a pooled analysis of 8,525 cases and 9,859 controls. Cancer Prev Res 2013;6(8):811-21. PMCID: PMC3766843.

Setiawan VW, Yang HP, Pike MC, McCann S, Yu H, Xiang Y-B, Wolk A, Wentzensen N, Weiss N, Webb P, van den Brandt PA, van de Vijver K, Thompson PJ, Strom B, Spurdle AB, Soslow

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R, Shu X-O, Schairer C, Sacerdote C, Rohan T, Robien K, Risch HA, Ricceri F, Rebbeck T, Rastogi R, Prescott J, Polidoro S, Park Y, Olson SH, Moysich K, Miller AB, McCullough M, Matsuno R, Magliocco AM, Lurie G, Lu L, Lissowska J, Liang X, Lacey JV, Kolonel L, Henderson B, Hankinson S, Hakansson N, Goodman M, Gaudet MM, Garcia-Closas M, Friedenreich C, Freudenheim J, Doherty J, de Vivo I, Courneya KS, Cook L, Chen C, Cerhan JR, Cai H, Brinton L, Bernstein L, Anderson K, Anton-Culver H, Schouten L, Horn-Ross P. Type I and II endometrial cancers: have they different risk factors? J Clin Oncol 2013;31(20):2607-18. PMCID: PMC3699726.

Olsen CM, Nagle CM, Whiteman DC, Ness R, Pearce CL, Pike MC, Rossing MA, Terry KL, Wu AH, Australian Cancer Study (Ovarian Cancer), Australian Ovarian Cancer Study Group, Risch HA, Yu H, Doherty JA, Chang-Claude J, Hein R, Nickels S, Wang-Gohrke S, Goodman MT, Carney ME, Matsuno RK, Lurie G, Moysich K, Kjaer SK, Jensen A, Hogdall E, Goode EL, Fridley BL, Vierkant RA, Larson MC, Schildkraut J, Hoyo C, Moorman P, Weber RP, Cramer DW, Vitonis AF, Bandera EV, Olson SH, Rodriguez-Rodriguez L, King M, Brinton LA, Yang H, Garcia-Closas M, Lissowska J, Anton-Culver H, Ziogas A, Gayther SA, Ramus SJ, Menon U, Gentry-Maharaj A, Webb PM, Ovarian Cancer Association Consortium. Obesity and risk of ovarian cancer subtypes: evidence from the Ovarian Cancer Association Consortium. Endocr Relat Cancer 2013;20(2);251-62. PMCID: PMC3857135.

Arem H, Bobe G, Sampson J, Subar AF, Park Y, Risch H, Hollenbeck A, Mayne ST, Stolzenberg-Solomon RZ. Flavonoid intake and risk of pancreatic cancer in the National Institutes of Health-AARP Diet and Health Study Cohort. Br J Cancer 2013;108(5):1168-72. PMCID: PMC3619057.

Faber MT, Kjær SK, Dehlendorff C, Chang-Claude J, Andersen KK, Høgdall E, Webb PM, Jordan SM, The Australian Cancer Study (Ovarian Cancer), Australian Ovarian Cancer Study Group, Rossing MA, Doherty JA, Goodman MT, Ness R, Goode EL, Schildkraut J, Cramer DW, Terry KL, Bandera EV, Olson SH, Kiemeney LA, Massuger L, Moysich K, Odunsi K, Song H, Pharaoh P, Whittemore A, McGuire V, Sieh W, Sutphen R, Narod SA, Menon U, Gayther SA, Ramus SJ, Gentry-Maharaj A, Pearce CL, Risch HA, Jensen A, Ovarian Cancer Association Consortium. Cigarette smoking and risk of ovarian cancer—a pooled analysis of 21 case-control studies. Cancer Causes Control 2013;24(5):989-1004. PMCID: PMC3818570.

Permuth-Wey J, Lawrenson K, Shen HC, Velkova A, Tyrer JP, Chen Z, Lin H-Y, Chen YA, Tsai Y-Y, Qu X, Ramus SJ, Karevan R, Lee J, Lee N, Larson MC, Aben KK, Anton-Culver H, Antonenkova N, Antoniou A, Armasu SM, Australian Cancer Study, Australian Ovarian Cancer Study, Bacot F, Baglietto L, Bandera EV, Barnholtz-Sloan J, Beckmann MW, Birrer MJ, Bloom G, Bogdanova N, Brinton LA, Brooks-Wilson A, Brown R, Butzow R, Cai Q, Campbell I, Chang-Claude J, Chanock S, Chenevix-Trench G, Cheng JQ, Cicek MS, Coetzee GA, Consortium of Investigators of Modifiers of BRCA1/2, Cook LS, Couch FJ, Cramer DW, Cunningham JM, Dansonka-Mieszkowska A, Despierre E, Doherty JA, Dörk T, du Bois A, Dürst M, Easton DF, Eccles D, Edwards R, Ekici AB, Fasching PA, Fenstermacher DA, Flanagan JM, Garcia-Closas M, Gentry-Maharaj A, Giles GG, Glasspool RM, Gonzalez-Bosquet J, Goodman MT, Gore M, Górski B, Gronwald J, Hall P, Halle MK, Harter P, Heitz F, Hillemanns P, Hoatlin M, Høgdall CK, Høgdall E, Hosono S, Jakubowska A, Jensen A, Jim H, Kalli KR, Karlan BY, Kaye SB, Kelemen LE, Kiemeney LA, Kikkawa F, Konecny GE, Krakstad C, Krüger Kjaer S, Kupryjanczyk J, Lambrechts D, Lambrechts S, Lancaster JM, Le ND, Leminen A, Levine DA, Liang D, Lim BK, Lin J, Lissowska J, Lu KH, Lubi ski J, Lurie G, Massuger LF, Matsuo K, McGuire V, McLaughlin JR, Menon U, Modugno F, Moysich KB, Nakanishi T, Narod SA, Nedergaard L, Ness RB, Nevanlinna H, Nickels S, Noushmehr H,

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Odunsi K, Olson SH, Orlow I, Paul J, Pearce CL, Pejovic T, Pelttari LM, Pike MC, Poole EM, Raska P, Renner SP, Risch HA, Rodriguez-Rodriguez L, Rossing MA, Rudolph A, Runnebaum IB, Rzepecka IK, Salvesen HB, Schwaab I, Severi G, Shridhar V, Shu X-O, Shvetsov YB, Sieh W, Song H, Southey MC, Spiewankiewicz B, Stram D, Sutphen R, Teo S-H, Terry KL, Tessier DC, Thompson PJ, Tworoger SS, van Altena AM, Vergote I, Vierkant RA, Vincent D, Vitonis AF, Wang-Gohrke S, Weber RP, Wentzensen N, Whittemore AS, Wik E, Wilkens LR, Winterhoff B, Woo YL, Wu AH, Xiang Y-B, Yang HP, Zheng W, Ziogas A, Zulkifli F, Phelan CM, Iversen E, Schildkraut JM, Berchuck A, Fridley BL, Goode EL, Pharoah PDP, Monteiro ANA, Sellers TA, Gayther SA. Identification and molecular characterization of a new ovarian cancer susceptibility locus at 17q21.31. Nat Commun 2013;4:1627. PMCID: PMC3709460.

Levine DM, Ek WE, Zhang R, Liu X, Onstad L, Sather C, Lao-Sirieix P, Gammon MD, Corley DA, Shaheen NJ, Bird NC, Hardie LJ, Murray LJ, Reid BJ, Chow W-H, Risch HA, Nyrén O, Ye W, Liu G, Romero Y, Bernstein L, Wu AH, Casson AG, Chanock S, Harrington P, Caldas I, Debiram-Beecham I, Caldas C, Hayward NK, Pharoah P, Fitzgerald R, MacGregor S, Whiteman DC, Vaughan TL. A genome-wide association study identifies new susceptibility loci for esophageal adenocarcinoma and Barrett’s Esophagus. Nat Genet 2013; 45(12):1487-93. PMCID: PMC3840115.

Klein AP, Lindström S, Mendelsohn JB, Steplowski E, Arslan AA, Bueno-de-Mesquita HB, Fuchs CS, Gallinger S, Gross M, Helzlsouer K, Holly EA, Jacobs EJ, LaCroix A, Li D, Mandelson MT, Olson SH, Petersen GM, Risch HA, Stolzenberg-Solomon RZ, Zheng W, Amundadottir L, Albanes D, Allen NE, Bamlet WR, Boutron-Ruault M-C, Buring JE, Bracci PM, Canzian F, Clipp S, Cotterchio M, Duell EJ, Elena J, Gaziano JM, Giovannucci EL, Goggins M, Hallmans G, Hassan M, Hutchinson A, Hunter DJ, Kooperberg C, Kurtz RC, Liu S, Overvad K, Palli D, Patel AV, Rabe KG, Shu X-O, Slimani N, Tobias GS, Trichopoulos D, Van Den Eeden SK, Vineis P, Virtamo J, Wactawski-Wende J, Wolpin BM, Yu H, Yu K, Zeleniuch-Jacquotte A, Chanock SJ, Hoover RN, Hartge P, Kraft P. An absolute risk model to identify individuals at elevated risk for pancreatic cancer in the general population. PLoS One 2013;8(9):e72311. PMCID: PMC3772857.

Bosetti C, Lucenteforte E, Bracci PM, Ji B-T, Negri E, Neale RE, Risch HA, Olson SH, Gallinger S, Miller AB, Bueno-de-Mesquita HB, Talamini R, Polesel J, Ghadirian P, Baghurst PA, Zatonski W, Fontham E, Holly EA, Gao Y-T, Yu H, Kurtz RC, Cotterchio M, Maisonneuve P, Zeegers MP, Duell EJ, Boffetta P, La Vecchia C. Ulcer, gastric surgery and pancreatic cancer risk: an analysis from the International Pancreatic Cancer Case-control Consortium (PanC4). Ann Oncol 2013;24(11):2903-10. PMCID: PMC3811904.

Sieh W, Salvador S, McGuire V, Weber RP, Terry KL, Rossing MA, Risch H, Wu AH, Webb PM, Moysich K, Doherty JA, Felberg A, Miller D, Jordan SJ, Australian Cancer Study (Ovarian Cancer), Australian Ovarian Cancer Study Group, Goodman MT, Lurie G, Chang-Claude J, Rudolph A, Krüger Kjær S, Jensen A, Høgdall E, Bandera EV, Olson SH, King MG, Rodriguez-Rodriguez L, Kiemeney LA, Marees T, Massuger LF, van Altena AM, Ness RB, Cramer DW, Pike MC, Pearce CL, Berchuck A, Schildkraut JM, Whittemore, AS, on behalf of the Ovarian Cancer Association Consortium. Tubal ligation and risk of ovarian cancer subtypes: a pooled analysis of case-control studies. Int J Epidemiol 2013;42(2):579-89.PMCID: PMC3619957.

Arem H, Neuhouser ML, Irwin ML, Cartmel B, Lu L, Risch H, Mayne ST, Yu H. Omega-3 and omega-6 fatty acid intakes and endometrial cancer risk in a population-based case-control study. Eur J Nutr 2013;52(3):1251-60. PMCID: PMC3548981.

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Tran B, Whiteman DC, Webb PM, Fritschi L, Fawcett J, Risch HA, Lucas R, Pandeya N, SchulteA, Neale RE, for the Queensland Pancreatic Cancer Study Group. Association between ultraviolet radiation, skin sun sensitivity and risk of pancreatic cancer. Cancer Epidemiology2013;37(6):886-92. *Not a result of NIH funding.

Wang J, Zhang W, Sun L, Yu H, Risch HA, Ni Q-X, Gao Y-T. Dietary energy density is positively associated with risk of pancreatic cancer in urban Shanghai Chinese. J Nutr2013;143(10):1626-9. PMCID: PMC3771813.

Shen H, Fridley BL, Song H, Lawrenson K, Cunningham JM, Ramus SJ, Cicek MS, Tyrer J, Stram D, Larson MC, Köbel M, PRACTICAL Consortium, Ziogas A, Zheng W, Yang HP, Wu AH, Wozniak EL, Woo YL, Winterhoff B, Wik E, Whittemore AS, Wentzensen N, Weber RP, Vitonis AF, Vincent D, Vierkant RA, Vergote I, Van Den Berg D, Van Altena AM, Tworoger SS, Thompson PJ, Tessier DC, Terry KL, Teo S-H, Templeman C, Stram DO, Southey MC, Sieh W, Siddiqui N, Shvetsov YB, Shu X-O, Shridhar V, Wang-Gohrke S, Severi G, Schwaab I, Salvesen HB, Rzepecka IK, Runnebaum I, Rossing MA, Rodriguez-Rodriguez L, Risch HA,Renner SP, Poole EM, Pike MC, Phelan CM, Pelttari LM, Pejovic T, Paul J, Orlow I, Omar SZ, Olson SH, Odunsi K, Nickels S, Nevanlinna H, Ness RB, Narod SA, Nakanishi T, Moysich KB, Monteiro ANA, Moes-Sosnowska J, Modugno F, Menon U, McLaughlin JR, McGuire V, Matsuo K, Mat Adenan NA, Massuger LFG, Lurie G, Lundvall L, Lubi ski J, Lissowska J, Levine DA, Leminen A, Lee AW, Le ND, Lambrechts S, Lambrechts D, Kupryjanczyk J, Krakstad C, Konecny GE, Krüger Kjaer S, Kiemeney LA, Kelemen LE, Keeney GL, Karlan BY, Karevan R, Kalli KR, Kajiyama H, Ji B-T, Jensen A, Jakubowska A, Iversen E, Hosono S, Høgdall CK, Høgdall E, Hoatlin M, Hillemanns P, Heitz F, Hein R, Harter P, Halle MK, Hall P, Gronwald J, Gore M, Goodman MT, Giles GG, Gentry-Maharaj A, Garcia-Closas M, Flanagan JM, Fasching PA, Ekici AB, Edwards R, Eccles D, Easton DF, Dürst M, du Bois A, Dörk T, Doherty JA, Despierre E, Dansonka-Mieszkowska A, Cybulski C, Cramer DW, Cook LS, Chen X, Charbonneau B, Chang-Claude J, Campbell I, Butzow R, Bunker CH, Brueggmann D, Brown R, Brooks-Wilson A, Brinton LA, Bogdanova N, Block MS, Benjamin E, Beesley J, Beckmann MW, Bandera EV, Baglietto L, Bacot F, Armasu SM, Antonenkova N, Anton-Culver H, Aben KK, Australian Ovarian Cancer Study Group, Australian Cancer Study, Schildkraut JM, Sellers TA, Huntsman D, Berchuck A, Chenevix-Trench G, Gayther SA, Pharoah PDP, Laird PW, Goode EL, Pearce CL. Epigenetic analysis leads to identification of HNF1B as a subtype-specific susceptibility gene for ovarian cancer. Nat Commun2013;4(1628):1-10. PMCID: PMC3848248.

Bojesen SE, Pooley KA, Johnatty SE, Beesley J, Michailidou K, Tyrer JP, Edwards SL, Pickett HA, Shen HC, Smart CE, Hillman KM, Mai PL, Lawrenson K, Stutz MD, Lu Y, Karevan R, Woods N, Johnston RL, French JD, Chen X, Wesicher M, Nielsen SF, Maranian MJ, Ghoussaini M, Ahmed S, Baynes C, Humphreys MK, Wang J, Dennis J, McGuffog L, Barrowdale D, Lee A, Healey S, Lush M, Tessier DC, Vincent D, Bacot F, Australian Cancer Study, Australian Ovarian Cancer Study Group, Vergote I, Lambrechts S, Despierre E, Risch HA, González-Neira A, Rossing MA, Pita G, Doherty JA, Álvarez N, Larson MC, Fridley BL, Schoof N, Chang-Claude J, Cicek MS, Peto J, Kalli KR, Broeks A, Armasu SM, Schmidt MK, Braaf LM, Winterhoff B, Nevanlinna H, Konecny GE, Lambrechts D, Rogmann L, Guénel P,Teoman A, Milne RL, Garcia JJ, Cox A, Shridhar V, Burwinkel B, Marme F, Hein R, Sawyer EJ, Haiman CA, Wang-Gohrke S, Andrulis IL, Moysich KB, Hopper JL, Odunsi K, Lindblom A, Giles GG, Brenner H, Simard J, Lurie G, Fasching PA, Carney ME, Radice P, Wilkens LR, Swerdlow A, Goodman MT, Brauch H, García-Closas M, Hillemanns P, Winqvist R, Dürst M, Devilee P, Runnebaum I, Jakubowska A, Lubinski J, Mannermaa A, Butzow R, Bogdanova

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NV, Dörk T, Pelttari L, Zheng W, Leminen A, Anton-Culver H, Bunker CH, Kristensen V, Ness RB, Muir K, Edwards R, Meindl A, Heitz F, Matsuo K, du Bois A, Wu AH, Harter P, Teo S-H, Schwaab I, Shu X-O, Blot W, Hosono S, Kang D, Nakanishi T, Hartman M, Yatabe Y, Hamann U, Karlan BY, Sangrajrang S, Krüger Kjaer S, Gaborieau V, Jensen A, Eccles D, Høgdall E, Shen C-Y, Brown J, Woo YL, Shah M, Noor Azmi MA, Luben R, Omar SZ, Czene K, Vierkant RA, Nordestgaard BG, Flyger H, Vachon C, Olson JE, Wang X, Levine DA, Rudolph A, Palmieri Weber R, Flesch-Janys D, Iversen E, Nickels S, Schildkraut JM, Dos Santos Silva I, Cramer DW, Gibson L, Terry KL, Fletcher O, Vitonis AF, van der Schoot CE, Poole EM, Hogervorst FBL, Tworoger SS, Liu J, Bandera EV, Li J, Olson SH, Humphreys K, Orlow I, Blomqvist C, Rodriguez-Rodriguez L, Aittomäki K, Salvesen HB, Muranen TA, Wik E, Brouwers B, Krakstad C, Wauters E, Halle MK, Wildiers H, Kiemeney LA, Mulot C, Aben KK, Laurent-Puig P, van Altena AM, Truong T, Massuger LF, Benitez J, Pejovic T, Arias Perez JI, Hoatlin M, Zamora MP, Cook LS, Balasubramanian SP, Kelemen LE, Schneeweiss A, Le ND, Sohn C, Brooks-Wilson A, Tomlinson I, Kerin MJ, Miller N, Cybulski C, kConFab Investigators, Henderson BE, Menkiszak J, Schumacher F, Wentzensen N, Marchand LL, Yang HP, Mulligan AM, Glendon G, Engelholm SA, Knight JA, Høgdall CK, Apicella C, Gore M, Tsimiklis H, Song H, Southey MC, Jager A, van den Ouweland AM, Brown R, Martens JW, Flanagan JM, Kriege M, Paul J, Margolin S, Siddiqui N, Severi G, Whittemore AS, Baglietto L, McGuire V, Stegmaier C, Sieh W, Müller H, Arndt V, Labrèche F, Gao Y-T, Goldberg MS, Yang G, Dumont M, McLaughlin JR, Hartmann A, Ekici AB, Beckmann MW, Phelan CM, Lux MP, Permuth-Wey J, Peissel B, Sellers TA, Ficarazzi F, Barile M, Ziogas A, Ashworth A, Gentry-Maharaj A, Jones M, Ramus SJ, Orr N, Menon U, The Genica Network, Pearce CL, Brüning T, Pike MC, Ko Y-D, Lissowska J, Figueroa J, Kupryjanczyk J, Chanock SJ, Dansonka-Mieszkowska A, Jukkola-Vuorinen A, Rzepecka IK, Pylkäs K, Bidzinski M, Kauppila S, Hollestelle A, Seynaeve C, Monteiro ANA, Tollenaar RAM, Durda K, Jaworska K, Hartikainen JM, Kosma V-M, Kataja V, Antonenkova NN, Long J, Shrubsole M, Deming-Halverson S, Lophatananon A, Siriwanarangsan P, Stewart-Brown S, Ditsch N, Lichtner P, Schmutzler RK, Ito H, Iwata H, Tajima K, Tseng C-C, Stram DO, van den Berg D, Yip CH, Ikram MK, Teh Y-C, Cai H, Lu W, Signorello LB, Cai Q, Noh D-Y, Yoo K-Y, Miao H, Iau PT, Teo YY, McKay J, Shapiro C, Ademuyiwa F, Fountzilas G, Hsiung C-N, Yu J-C, Hou M-F, Healey CS, Luccarini C, Wang Q, Peock S, Stoppa-Lyonnet D, Peterlongo P, SWE-BRCA, Rebbeck TR, Piedmonte M, Singer CF, Friedman E, Thomassen M, Offit K, Hansen TVO, Neuhausen SL, Szabo CI, Blanco I, Garber J, Narod SA, Weitzel JN, Montagna M, Olah E, Godwin AK, Yannoukakos D, Goldgar DE, Caldes T, Imyanitov EN, Tihomirova L, Arun BK, Campbell I, Mensenkamp AR, van Asperen CJ, van Roozendaal K, Meijers-Heijboer HEJ, HEBON, Collée JM, Oosterwijk JC, Hooning MJ, Rookus MA, van der Luijt RB, van Os TAM, Evans DG, Frost D, Fineberg E, Embrace, Barwell J, Walker L, Kennedy MJ, Platte R, Davidson R, Ellis SD, Cole T, De Paillerets BB, Buecher B, Damiola F, Gemo Study Collaborators, Faivre L, Frenay M, Sinilnikova OM, Caron O, Giraud S, Mazoyer S, Bonadona V, Caux-Moncoutier V, Toloczko-Grabarek A, Gronwald J, Byrski T, Spurdle AB, Bonanni B, Zaffaroni D, Giannini G, Bernard L, Dolcetti R, Manoukian S, Norbert A, Engel C, Deissler H, Rhiem K, Meindl A, Niederacher D, Plendl H, Sutter C, Wappenschmidt B, Borg A, Melin B, Rantala J, Soller M, Nathanson KL, Domchek SM, Rodriguez GC, Salani R, Geschwantler Kaulich D, Tea M-K, Paluch SS, Laitman Y, Skytte A-B, Kruse TA, Jensen UB, Robson M, Gerdes A-M, Ejlertsen B, Foretova L, Savage SA, Lester J, Soucy P, Kuchenbaecker KB, Olswold C, Cunningham JM, Slager S, Pankratz VS, Dicks E, Lakhani SR, Couch FJ, Hall P, Gayther SA, Pharoah PDP, Reddel RR, Goode EL, Greene MH, Easton DF, Berchuck A, Antoniou AC, Chenevix-Trench G, Dunning AM. Multiple independent TERT variants

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associated with telomere length and risks of breast and ovarian cancer. Nat Genet2013;45(4):371-86. PMCID: PMC3670748.

Pharoah PDP, Tsai Y-Y, Ramus SJ, Phelan CM, Goode EL, Lawrenson K, Buckley M, Fridley BL, Tyrer JP, Shen H, Weber R, Karevan R, Larson MC, Song H, Tessier DC, Bacot F, Vincent D, Cunningham JM, Dennis J, Dicks E, Australian Cancer Study, Australian Ovarian Cancer Study Group, Aben KK, Anton-Culver H, Antonenkova N, Armasu SM, Baglietto L, Bandera EV, Beckmann MW, Bloom G, Bogdanova N, Brenton J, Brinton LA, Brooks-Wilson A, Brown R, Butzow R, Campbell I, Carney ME, Carvalho RS, Chang-Claude J, Chen A, Chen Z, Chow W-H, Cicek MS, Coetzee G, Cook LS, Cramer DW, Cybulski C, Dansonka-Mieszkowska A, Despierre E, Doherty JA, Dörk T, du Bois A, Dürst M, Eccles D, Edwards R, Ekici AB, Fasching PA, Fenstermacher D, Flanagan J, Gao Y-T, Garcia-Closas M, Gentry-Maharaj A, Giles G, Gjyshi A, Gore M, Gronwald J, Guo Q, Halle MK, Harter P, Hein A, Heitz F, Hillemanns P, Hoatlin M, Høgdall E, Høgdall CK, Hosono S, Jakubowska A, Jensen A, Kalli KR, Karlan BY, Kelemen L, Kiemeney LA, Krüger Kjaer S, Konecny GE, Krakstad C, Kupryjanczyk J, Lambrechts D, Lambrechts S, Le ND, Lee N, Lee J, Leminen A, Lim BK, Lissowska J, Lubi ski J, Lundvall L, Lurie G, Massuger LFAG, Matsuo K, McGuire V, McLaughlin JR, Menon U, Modugno F, Moysich KB, Nakanishi T, Narod SA, Ness RB, Nevanlinna H, Nickels S, Noushmehr H, Odunsi K, Olson SH, Orlow I, Paul J, Pejovic T, Pelttari LM, Permuth-Wey J, Pike MC, Poole EM, Qu X, Risch HA, Rodriguez-Rodriguez L, Rossing MA, Rudolph A, Runnebaum I, Rzepecka IK, Salvesen HB, Schwaab I, Severi G, Shen H, Shridhar V, Shu X-O, Sieh W, Southey MC, Spellman P, Tajima K, Teo S-H, Thompson PJ, Timorek A, Tworoger SS, van Altena AM, Van Den Berg D, Vergote I, Vierkant RA, Vitonis AF, Wang-Gohrke S, Wentzensen N, Whittemore AS, Wik E, Winterhoff B, Woo YL, Wu AH, Yang HP, Zheng W, Ziogas A, Zulkifli F, Goodman MT, Hall P, Easton DF, Pearce CL, Berchuck A, Chenevix-Trench G, Iversen E, Monteiro AN, Gayther SA, Schildkraut JM, Sellers TA. GWAS meta analysis and replication identifies three new susceptibility loci for ovarian cancer. Nat Genet 2013;45(4):362-72. PMCID: PMC3693183.

Delahanty RJ, Xiang Y-B, Spurdle A, Beeghly-Fadiel A, Long J, Thompson D, Tomlinson I, Yu H, Lambrechts D, Dörk T, Goodman MT, Zheng Y, Salvesen HB, Bao P-P, Amant F, Beckmann MW, Coenegrachts L, Coosemans A, Dubrowinskaja N, Dunning A, Runnebaum I, Easton D, Ekici AB, Fasching PA, Halle MK, Hein A, Howarth K, Gorman M, Kaydarova D, Krakstad C, Lose F, Lu L, Lurie G, O'Mara T, Matsuno RK, Pharoah P, Risch H, Schwake A, Trovik J, Turmanov N, Wen W, Lu W, Cai Q, Zheng W, Shu X-O. Polymorphisms in inflammation pathway genes and endometrial cancer risk. Cancer Epidemiol Biomarkers Prev2013;22(2):216-23. PMCID: PMC3677562.

Narod SA, Moody JRK, Rosen B, Fan I, Risch [H]A, Sun P, McLaughlin JR. Estimating survival rates after ovarian cancer among women tested for BRCA1 and BRCA2 mutations. Clin Genet2013;83(3):232-7. *NIH funding pre-dates mandate.

McLaughlin JR, Rosen B, Moody J, Pal T, Fan I, Shaw P, Risch HA, Sellers TA, Sun P, Narod SA. Long-term ovarian cancer survival associated with mutation in BRCA1 or BRCA2. J Natl Cancer Inst 2013;105(2):141-8. *NIH funding pre-dates mandate.

Kelemen LE, Bandera EV, Terry KL, Rossing MA, Brinton LA, Doherty JA, Ness RB, Krüger Kjær S, Chang-Claude J, Köbel M, Lurie G, Thomson PJ, Carney ME, Moysich K, Edwards RP, Bunker CH, Jensen A, Høgdall E, Cramer DW, Vitonis AF, Olson SH, King M, Chandran U, Lissowska J, Garcia-Closas M, Yang H, Webb PM, Schildkraut JM, Goodman MT, Risch HA. Recent alcohol consumption and risk of incident ovarian carcinoma: a pooled analysis of

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5,342 cases and 10,358 controls from the Ovarian Cancer Association Consortium. BMC Cancer 2013;13:28. PMCID: PMC3568733.

Risch HA, Lu L, Wang J, Zhang W, Ni Q-X, Gao Y-T, Yu H. ABO blood group and risk of pancreatic cancer: a study in Shanghai and meta-analysis. Am J Epidemiol 2013;177(12):1326-37. PMCID: PMC3732019.

Parikh H, Jia J, Zhang X, Chung C, Jacobs KB, Yeager M, Boland J, Hutchinson A, Burdett L, Risch HA, Jacobs EJ, Stolzenberg-Solomon RZ, Chanock SJ, Wolpin BM, Petersen GM, Fuchs CS, Hartge P, Amundadottir L. A re-sequence analysis of genomic loci on chromosomes 1q32.1, 5p15.33 and 13q22.1 associated with pancreatic cancer risk. Pancreas 2013;42(2):209-215. PMCID: PMC3618611.

2012Hoyo C, Cook MB, Kamangar F, Freedman ND, Whiteman DC, Bernstein L, Brown LM, Risch

HA, Ye W, Sharp L, Wu AH, Ward MH, Casson AG, Murray LJ, Corley DA, Nyren O, Pandeya N, Vaughan TL, Chow W-H, Gammon MD. Body mass index in relation to oesophageal and oesophagogastric junction adenocarcinomas: a pooled analysis from the international BEACON consortium. Int J Epidemiol 2012;41(6):1706-18. PMCID: PMC3535758.

Bosetti C, Lucenteforte E, Silverman DT, Petersen G, Bracci PM, Ji BT, Negri E, Li D, Risch HA, Olson SH, Gallinger S, Miller AB, Bueno-de-Mesquita HB, Talamini R, Polesel J, Ghadirian P, Baghurst PA, Zatonski W, Fontham E, Bamlet WR, Holly EA, Bertuccio P, Gao YT, Hassan M, Yu H, Kurtz RC, Cotterchio M, Su J, Maisonneuve P, Duell EJ, Boffetta P, La Vecchia C. Cigarette smoking and pancreatic cancer: an analysis from the International Pancreatic Cancer Case-Control Consortium (PanC4). Ann Oncol 2012;23(7):1880-88. PMCID: PMC3387822.

Lu L, Zhu G, Zhang C, Deng Q, Katsaros D, Mayne ST, Risch HA, Mu L, Canuto EM, Gregori G, Benedetto C, Yu H. Association of large noncoding RNA HOTAIR expression and its downstream intergenic CpG island methylation with survival in breast cancer. Breast Cancer Res Treat 2012;136(3)875-83. *Not a result of NIH funding.

Wang J, Zhang W, Sun L, Yu H, Ni Q-X, Risch H, Gao Y-T. Green tea drinking and risk of pancreatic cancer: a large-scale, population-based case-control study in urban Shanghai. Cancer Epidemiol 2012;36(6):e354-8. PMCID: PMC3490023.

Raska P, Iversen E, Chen A, Chen Z, Fridley BL, Permuth-Wey J, Tsai Y-Y, Vierkant RA, Goode EL, Risch H, Schildkraut JM, Sellers TA, Barnholtz-Sloan J. European American stratification in ovarian cancer case control data: the utility of genome-wide data for inferring ancestry.PLoS One 2012;7(5): e35235. doi:10.1371/journal.pone.0035235. PMCID: PMC3348917.

Su Z, Gay LJ, Strange A, Palles C, Band G, Whiteman DC, Lescai F, Langford C, Nanji M, Edkins S, van der Winkel A, Levine D, Sasieni P, Bellenguez C, Howarth K, Freeman C, Trudgill N, Tucker AT, Pirinen M, Peppelenbosch MP, van de rLaan LJW, Kuipers EJ, Drenth JPH, Peters WH, Reynolds JV, Kelleher DP, McManus R, Grabsch H, Prenen H, Bisschops R, Krishnadath K, Siersema PD, van Baal JW, Middleton M, Petty R, Gillies R, Burch N, Bhandari P, Paterson S, Edwards C, Penman I, Vaidya K, Ang Y, Murray I, Patel P, Ye W, Mullins P, Wu AH, Bird NC, Dallal H, Shaheen NJ, Murray LJ, Koss K, Bernstein L, Romero Y, Hardie LJ, Zhang R, Winter H, Corley DA, Panter S, Risch HA, Reid BJ, Sargeant I, Gammon MD, Smart H, Dhar A, McMurtry H, Ali H, Liu G, Casson AG, Chow W-H, Rutter M, Tawil A, Morris D, Nwokolo C, Isaacs P, Rodgers C, Ragunath K, MacDonald C, Haigh C, Monk D, Davies G,

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Wajed S, Johnston D, Gibbons M, Cullen S, Church N, Langley R, Griffin M, Alderson D, Deloukas P, Hunt SE, Gray E, Dronov S, Potter SC, Tashakkori-Ghanbaria A, Anderson M, Brooks C, Blackwell JM, Bramon E, Brown MA, Casas JP, Corvin A, Duncanson A, Markus HS, Mathew CG, Palmer CNA, Plomin R, Rautanen A, Sawcer SJ, Trembath RC, Viswanathan AC, Wood N, Trynka G, Wijmenga C, Cazier J-B, Atherfold P, Nicholson AM, Gellatly NL, Glancy D, Cooper SC, Cunningham D, Lind T, Hapeshi J, Ferry D, Rathbone B, Brown J, Love S, Attwood S, MacGregor S, Watson P, Sanders S, Ek W, Harrison RF, Moayyedi P, de Caestecker J, Barr H, Stupka E, Vaughan TL, Peltonen L, Spencer CCA, Tomlinson I, Donnelly P, Jankowski JAZ. Common variants at the MHC locus and at chromosome 16q24.1 predispose to Barrett’s Esophagus. Nat Genet 2012;44(10):1131-6. PMCID: PMC3459818.

Ji Y, Shen M-C, Jin X-L, Zhu M-H, Wang H, Ni Q-X, Zhang W, Wang J, Sun L, Yu H, Risch H,Gao Y-T. Pathologic characteristics of pancreatic cancer in Shanghai urban area: preliminary analysis of 350 cases. Zhong Liu [Tumor] 2012;32(3):199-202. (Publication in Chinese).

Pal T, Akbari MR, Sun P, Lee J-H, Fulp J, Thompson Z, Coppola D, Nicosia S, Sellers TA, McLaughlin J, Risch HA, Rosen B, Shaw P, Schildkraut J, Narod SA. Frequency of mutations in mismatch repair genes in a population-based study of women with ovarian cancer. Br J Cancer 2012;107(10):1783-90. PMCID: PMC3493867.

Collaborative Group on Epidemiological Studies of Ovarian Cancer. Ovarian cancer and smoking: individual participant meta-analysis including 28,114 women with ovarian cancer from 51 epidemiological studies. Lancet Oncol 2012;13(9):946-56. *Not a result of NIH funding.

Lu L, Katsaros D, Mayne ST, Risch HA, Benedetto C, Canuto EM, Yu H. Functional study of risk loci of stem cell-associated gene lin-28B and associations with disease survival outcomes in epithelial ovarian cancer. Carcinogenesis 2012;33(11):2119-25. *Not a result of NIH funding.

Fridley BL, Chalise P, Tsai Y-Y, Sun Z, Vierkant RA, Larson MC, Cunningham JM, Iversen ES, Fenstermacher D, Barnholtz-Sloan J, Asmann Y, Risch HA, Schildkraut JM, Phelan CM, Sutphen R, Sellers TA, Goode EL. Germline copy number variation and ovarian cancer survival. Front Genet 2012;3:142. PMCID: PMC3413872.

Kotsopoulos J, Moody JRK, Fan I, Rosen B, Risch HA, McLaughlin JR, Sun P, Narod SA. Height, weight, BMI and ovarian cancer survival. Gyn Oncol 2012;127(1):83-7. *NIH funding pre-dates mandate.

Li D, Duell EJ, Yu K, Risch HA, Olson SH, Kooperberg C, Wolpin BM, Jiao L, Dong X, Wheeler B, Arslan AA, Bueno-de-Mesquita HB, Fuchs CS, Gallinger S, Gross M, Hartge P, Hoover RN, Holly EA, Jacobs EJ, Klein AP, LaCroix A, Mandelson MT, Petersen G, Zheng W, Agalliu I, Albanes D, Boutron-Ruault M-C, Bracci PM, Buring JE, Canzian F, Chang K, Chanock SJ, Cotterchio M, Gaziano JM, Giovannucci EL, Goggins M, Hallmans G, Hankinson SE, Hoffman Bolton JA, Hunter DJ, Hutchinson A, Jacobs KB, Jenab M, Khaw K-T, Kraft P, Krogh V, Kurtz RC, McWilliams RR, Mendelsohn JB, Patel AV, Rabe KG, Riboli E, Shu X-O, Tjønneland A, Tobias GS, Trichopoulos D, Virtamo J, Visvanathan K, Watters J, Yu H, Zeleniuch-Jacquotte A, Amundadottir L, Stolzenberg-Solomon RZ. Pathway analysis of genome-wide association study data highlights pancreatic development genes as susceptibility factors for pancreatic cancer. Carcinogenesis 2012;33(7):1384-90. PMCID: PMC3405651.

Duell EJ, Lucenteforte E, Olson SH, Bracci PM, Li D, Risch HA, Silverman DT, Ji B-T, Gallinger S, Holly EA, Fontham EH, Maisonneuve P, Bueno-de-Mesquita HB, Ghadirian P, Kurtz RC, Ludwig E, Yu H, Lowenfels AB, Seminara D, Petersen GM, LaVecchia C, Boffetta P.

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Pancreatitis and pancreas cancer risk: a pooled analysis in the International Pancreatic Cancer Case-Control Consortium (PanC4). Ann Oncol 2012;23(11):2964-70. PMCID: PMC3477881.

Palmer AJ, Lochhead P, Hold GL, Rabkin CS, Chow WH, Lissowska J, Vaughan TL, Berry S, Gammon M, Risch H, El-Omar EM. Genetic variation in C20orf54, PLCE1 and MUC1 and the risk of upper gastrointestinal cancers in Caucasian populations. Eur J Cancer Prev 2012;21(6):541-4. PMCID: PMC3460062.

Jacobs KB, Yeager M, Zhou W, Wacholder S, Wang Z, Rodriguez-Santiago B, Hutchinson A, Deng X, Liu C, Horner M-J, Cullen M, Epstein CG, Burdett L, Dean MC, Chatterjee N, Sampson J, Chung CC, Kovaks J, Gapstur SM, Stevens VL, Teras LT, Gaudet MM, Albanes D, Weinstein SJ, Virtamo J, Taylor PR, Freedman ND, Abnet CC, Goldstein AM, Hu N, Yu K, Yuan J-M, Liao L, Ding T, Qiao Y-L, Gao Y-T, Koh W-P, Xiang Y-B, Tang Z-Z, Fan J-H, Aldrich MC, Amos C, Blot WJ, Bock CH, Gillanders EM, Harris CC, Haiman CA, Henderson BE, Kolonel LN, Marchand LL, McNeill LH, Rybicki BA, Schwartz AG, Signorello LB, Spitz MR, Wiencke JK, Wrensch M, Wu X, Zanetti KA, Ziegler RG, Figueroa JD, Garcia-Closas M, Malats N, Marenne G, Prokunina-Olsson L, Baris D, Schwenn M, Johnson A, Landi MT, Goldin L, Consonni D, Bertazzi PA, Rotunno M, Rajaraman P, Andersson U, Freeman LEB, Berg CD, Buring JE, Butler MA, Carreon T, Feychting M, Ahlbom A, Gaziano JM, Giles GG, Hallmans G, Hankinson SE, Hartge P, Henriksson R, Inskip PD, Johansen C, Landgren A, McKean-Cowdin R, Michaud DS, Melin BS, Peters U, Ruder AM, Sesso HD, Severi G, Shu X-O, Visvanathan K, White E, Wolk A, Zeleniuch-Jacquotte A, Zheng W, Silverman DT, Kogevinas M, Gonzalez JR, Villa O, Li D, Duell EJ, Risch HA, Olson SH, Kooperberg C, Wolpin BM, Jiao L, Hassan M, Wheeler W, Arslan AA, Bueno-de-Mesquita HB, Fuchs CS, Gallinger S, Gross MD, Holly EA, Klein AP, LaCroix A, Mandelson MT, Petersen G, Boutron-Ruault M-C, Bracci PM, Canzian F, Chang K, Cotterchio M, Giovannucci EL, Goggins M, Bolton JAH, Jenab M, Khaw K-T, Krogh V, Kurtz RC, McWilliams RR, Mendelsohn JB, Rabe KG, Riboli E, Tjønneland A, Tobias GS, Trichopoulos D, Elena JW, Yu H, Amundadottir L, Stolzenberg-Solomon RZ, Kraft P, Schumacher F, Stram D, Savage SA, Mirabello L, Andrulis I, Wunder J, García AP, Sierrasesúmaga L, Barkauskas DA, Gorlick RG, Purdue M, Chow W-H, Moore LE, Schwartz KL, Davis FG, Hsing AW, Berndt SI, Black A, Wentzensen N, Brinton LA, Lissowska J, Peplonska B, McGlynn KA, Cook MB, Graubard BI, Kratz CP, Greene MH,Erickson RL, Hunter DJ, Thomas G, Hoover RN, Real FX, Fraumeni JF, Caporaso NE, Tucker M, Rothman N, Pérez-Jurado LA, Chanock SJ. Detectable clonal mosaicism and its relationship to aging and cancer. Nat Genet 2012;44(6):651-8. PMCID: PMC3372921.

Lubin JH, Cook MB, Pandeya N, Vaughan TL, Abnet CC, Giffen C, Webb PM, Murray LJ, Casson AG, Risch HA, Ye W, Kamangar F, Bernstein L, Sharp L, Nyrén O, Gammon MD, Corley DA, Wu AH, Brown LM, Chow W-H, Ward MH, Freedman ND, Whiteman DC. The importance of exposure rate on odds ratios by cigarette smoking and alcohol consumption for esophageal adenocarcinoma and squamous cell carcinoma in the Barrett’s Esophagus and Esophageal Adenocarcinoma Consortium. Cancer Epidemiology 2012;36(3):306-16. PMCID:PMC3489030

Long J, Zheng W, Xiang Y-B, Lose F, Thompson D, Tomlinson I, Yu H, Wentzensen N, Lambrechts D, Dörk T, Dubrowinskaja N, Goodman MT, Salvesen HB, Fasching PA, Scott RJ, Delahanty R, Zheng Y, O'Mara T, Healey CS, Hodgson S, Risch H, Yang HP, Amant F, Turmanov N, Schwake A, Lurie G, Trovik J, Beckmann MW, Ashton K, Ji B-T, Bao P-P, Howarth K, Lu L, Lissowska J, Coenegrachts L, Kaidarova D, Dürst M, Thompson PJ, Krakstad C, Ekici AB, Otton G, Shi J, Zhang B, Gorman M, Brinton L, Coosemans A, Matsuno RK, Halle MK, Hein A, Proietto A, Cai H, Lu W, Dunning A, Easton D, Gao Y-T, Cai Q,

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Spurdle AB, Shu X-O. Genome-wide association study identifies a possible susceptibility locus for endometrial cancer. Cancer Epidemiol Biomarkers Prev 2012;21(6):980-7. PMCID:PMC3372671

Setiawan VW, Pike MC, Karageorgi S, Deming SL, Anderson K, Bernstein L, Brinton LA, Cai H, Cerhan JR, Cozen W, Chen C, Doherty J, Freudenheim JL, Goodman MT, Hankinson SE, Lacey JV Jr, Liang X, Lissowska J, Lu L, Lurie G, Mack T, Matsuno RK, McCann S, Moysich KB, Olson SH, Rastogi R, Rebbeck TR, Risch H, Robien K, Schairer C, Shu X-O, Spurdle AB, Strom BL, Australian National Endometrial Cancer Study Group, Thompson PJ, Ursin G, Webb PM, Weiss N, Wentzensen N, Xiang Y-B, Yang HP, Yu H, Horn-Ross PL, De Vivo I. Age at last birth in relation to risk of endometrial cancer: pooled analysis in the Epidemiology of Endometrial Cancer Consortium. Am J Epidemiol 2012;176(4):269-78. PMCID:PMC3491967

Pearce CL, Templeman C, Rossing MA, Lee A, Near A, Australian Cancer Study (Ovarian Cancer), Australian Ovarian Cancer Study Group, Doherty JA, Cushing-Haugen KL, Wicklund KG, Chang-Claude J, Hein R, Wang-Gohrke S, Lurie G, Wilkens LR, Carney ME, Goodman MT, Moysich10, Kjaer SK, Hogdall E, Jensen A, Goode EL, Fridley BL, Larson MC, Schildkraut JM, Palmieri RT, Cramer DW, Terry KL, Vitonis AF, Titus-Ernstoff L, Ziogas A, Brewster W, Anton-Culver H, Gentry Maharaj A, Ramus SJ, Anderson AR, Brueggmann D, Fasching PA, Gayther SA, Huntsman D, Menon U, Nagle CM, Ness R, Pike MC, Risch H,Webb PM, Wu AH, Berchuck A, Ovarian Cancer Association Consortium. Association between endometriosis and risk of histological subtypes of ovarian cancer: a pooled analysis of case–control studies. Lancet Oncol 2012;13(4):385-94. PMCID: PMC3664011.

Zeng H, Irwin ML, Lu L, Risch H, Mayne S, Mu L, Deng Q, Scarampi L, Mitidieri M, Katsaros D, Yu H.. Physical activity and breast cancer survival—an epigenetic link through reduced methylation of a tumor suppressor gene L3MBTL1. Breast Cancer Res Treat2012;133(1):127-35. *Not a result of NIH funding.

Liao LM, Vaughan TL, Corley DA, Cook MB, Casson AG, Kamangar F, Abnet CC, Risch HA,Giffen C, Freedman ND, Chow W-H, Sadeghi S, Pandeya N, Whiteman DC, Murray LJ, Bernstein L, Gammon MD, Wu AH. Nonsteroidal anti-inflammatory drug use reduces risk of adenocarcinomas of the esophagus and esophagogastric junction in a pooled analysis.Gastroenterology 2012;142(3):442-52. PMCID: PMC3488768.

Collaborative Group on Epidemiological Studies of Ovarian Cancer. Beral V, Hermon C, Peto R, Reeves G, Brinton L, Green AC, Marchbanks P, Negri E, Ness R, Peeters P, Vessey M, Calle EE, Rodriguez C, Dal Maso L, Talamini T, Cramer D, Hankinson SE, Tworoger SS, Chetrit A, Hirsh-Yechezkel G, Lubin F, Sadetzki S, Appleby P, Banks E, Berrington de Gonzalez A, Bull D, Crossley B, Goodill A, Green I, Green J, Key T, Collins R, Doll R, Agudo A, Gonzalez CA, Lee N, Ory HW, Peterson HB, Wingo PA, Martin N, Pardthaisong T, Silpisornkosol S, Theetranont C, Boosiri B, Chutivongse S, Jimakorn P, Virutamasen P, Wongsrichanalai C, Titus-Ernstoff L, Byers T, Rohan T, Mosgaard BJ, Yeates D, Marshall JR, Chang-Claude J, Anderson KE, Folsom AR, Rossing MA, Thomas D, Weiss N, Franceschi S, La Vecchia C, Adami HO, Magnusson C, Riman T, Weiderpass E, Wolk A, Freedman DM, Hartge P, Lacey JM, Hoover R, Schouten LJ, van den Brandt PA, Chantarakul N, Koetsawang S, Rachawat D, Graff-Iversen G, Selmer R, Bain CJ, Purdie DM, Siskind V, Webb PM, McCann SE, Hannaford P, Kay C, Binns CW, Lee AH, Zhang M, Nasca P, Coogan PF, Rosenberg L, Kelsey J, Paffenbarger R, Whittemore A, Katsouyanni K, Trichopoulou A, Trichopoulos D, Tzonou A, Dabancens A, Martinez L, Molina R, Salas O, Goodman MT, Laurie G, Carney ME, Wilkens

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LR, Bladstrom A, Olsson H, Grisso JA, Morgan M, Wheeler JE, Casagrande J, Pike MC, RK Ross RK, Wu AH, Kumle M, Lund E, McGowan L, Shu XO, Zheng W, Farley TMM, Holck S, Meirik O, Risch HA. Ovarian cancer and body size: Individual participant meta-analysis including 25,157 women with ovarian cancer from 47 epidemiological studies. PLoS Med 2012;9(4):e1001200. doi:10.1371/journal.pmed.1001200. *Not a result of NIH funding.

2011Permuth-Wey J, Chen Z, Tsai Y-Y, Lin H-Y, Chen YA, Barnholtz-Sloan J, Birrer MJ, Chanock

SJ, Cramer DW, Cunningham JM, Fenstermacher D, Fridley BL, Garcia-Closas M, Gayther SA, Gentry-Maharaj A, Gonzalez-Bosquet J, Iversen E, Jim H, McLaughlin J, Menon U, Narod SA, Phelan CM, Ramus SJ, Risch H, Song H, Sutphen R, Terry KL, Tyrer J, Vierkant RA, Wentzensen N, Lancaster JM, Cheng JQ, Berchuck A, Pharoah PDP, Schildkraut JM, Goode EL, Sellers TA on behalf of the Ovarian Cancer Association Consortium (OCAC). MicroRNA processing and binding site polymorphisms are not replicated in the Ovarian Cancer Association Consortium. Cancer Epidemiol Biomarkers Prev 2011;20:1793-7. PMCID: PMC3153581.

Permuth-Wey J, Kim D, Tsai Y-Y, Lin H-Y, Chen YA, Barnholtz-Sloan J, Birrer MJ, Gregory Bloom G, Chanock SJ, Chen Z, Cramer DW, Cunningham JM, Dagne G, Ebbert-Syfrett J, Fenstermacher D, Fridley BL, Garcia-Closas M, Gayther SA, Ge W, Gentry-Maharaj A, Gonzalez-Bosquet J, Goode EL, Iversen E, Jim H, Kong W, McLaughlin J, Menon U, Monteiro ANA, Narod SA, Pharoah PDP, Phelan CM, Qu X, Ramus SJ, Risch H, Schildkraut JM, Song H, Stockwell H, Sutphen R, Terry KL, Tyrer J, Vierkant RA, Wentzensen N, Lancaster JM, Cheng JQ, Sellers TA on behalf of the Ovarian Cancer Association Consortium (OCAC). LIN28B polymorphisms influence susceptibility to epithelial ovarian cancer.Cancer Res 2011;71:3896-903. PMCID: PMC3107389.

Lu L, Risch H, Irwin ML, Mayne ST, Cartmel B, Schwartz P, Rutherford T, Yu H. Long-term overweight and weight gain in early adulthood in association with risk of endometrial cancer. Int J Cancer 2011;129:1237-43. PMCID: PMC3125463.

Zhang S, Royer R, Li S, McLaughlin JR, Rosen B, Risch HA, Fan I, Bradley L, Shaw PA, Narod SA. Frequencies of BRCA1 and BRCA2 mutations among 1,342 unselected patients with invasive ovarian cancer. Gyn Oncol 2011;121:353-7. PMID:21324516. *NIH funding pre-dates mandate.

Freedman ND, Murray LJ, Kamangar F, Abnet CC, Cook MB, Nyrén O, Ye W, Wu AH, Bernstein L, Brown LM, Ward MH, Pandeya N, Green A, Casson AG, Giffen C, Risch HA,Gammon MD, Chow W-H, Vaughan TL, Corley DA, Whiteman DC. Alcohol intake and risk of esophageal adenocarcinoma: a pooled analysis from the BEACON Consortium. Gut 2011;60:1029-37. PMCID: PMC3439838.

Lu L, Zhang C, Zhu G, Irwin M, Risch H, Menato G, Mitidieri M, Katsaros D, Yu H. Telomerase expression and telomere length in breast cancer and their associations with adjuvant treatment and disease outcome. Breast Cancer Res 2011;13:R56:1-8. http://breast-cancer-research.com/content/13/3/R56. *Not a result of NIH funding.

Lu L, Katsaros D, Zhu Y, Hoffman A, Luca S, Marion CE, Mu L, Risch H, Yu H. Let-7A regulation of insulin-like growth factors in breast cancer. Breast Cancer Res Treat 2010, Published online: DOI 10.1007/s10549-010-1168-5. *Not a result of NIH funding.

Permuth-Wey J, Chen YA, Tsai Y-Y, Chen Z, Qu X, Lancaster JM, Stockwell H, Dagne G, Iversen E, Risch H, Barnholtz-Sloan J, Cunningham JM, Vierkant RA, Fridley BL, Sutphen

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R, McLaughlin J, Narod SA, Goode EL, Schildkraut JM, Fenstermacher D, Phelan CM, Sellers TA. Inherited variants in mitochondrial biogenesis genes may influence epithelial ovarian cancer risk. Cancer Epidemiol Biomarkers Prev 2011;20:1131-45. PMCID: PMC3111851.

Pharoah PDP, Palmieri RT, Ramus SJ, Gayther SA, Andrulis IL, Anton-Culver H, Antonenkova N, Antoniou AC, Goldgar D for the BCFR Investigators, Beattie MS, Beckmann MW, Birrer MJ, Bogdanova N, Bolton KL, Brewster W, Brooks-Wilson A, Brown R, Butzow R, Caldes T, Caligo MA, Campbell I, Chang-Claude J, Chen YA, Cook LS, Couch FJ, Cramer DW, Cunningham JM, Despierre E, Doherty JA, Dörk T, Dürst M, Eccles DM, Ekici AB, Easton D for the EMBRACE Investigators, Fasching PA, de Fazio A, Fenstermacher DA, Flanagan JM, Fridley BL, Friedman E, Gao B, Sinilnikova O for the GEMO Study Collaborators, Gentry-Maharaj A, Godwin AK, Goode EL, Goodman MT, Gross J, Hansen TVO, Harnett P, Rookus M for the HEBON Investigators, Heikkinen T, Hein R, Høgdall C, Høgdall E, Iversen ES, Jakubowska A, Johnatty SE, Karlan BY, Kauff ND, Kaye SB, Chenevix-Trench G for the kConFab Investigators and the Consortium of Investigators of Modifiers of BRCA1/2, Kelemen LE, Kiemeney LA, Krüger Kjaer S, Lambrechts D, LaPolla JP, Lázaro C, Le ND, Leminen A, Leunen K, Levine DA, Lu Y, Lundvall L, Macgregor S, Marees T, Massuger LF, McLaughlin JR, Menon U, Montagna M, Moysich KB, Narod SA, Nathanson KL, Nedergaard L, Ness RB, Nevanlinna H, Nickels S, Osorio A, Paul J, Pearce CL, Phelan CM, Pike MC, Radice P, Rossing MA, Schildkraut JM, Sellers TA, Singer CF, Song H, Stram DO, Sutphen R, Lindblom A for the SWE-BRCA Investigators, Terry KL, Tsai Y-Y, van Altena AM, Vergote I, Vierkant RA, Vitonis AF, Walsh C, Wang-Gohrke S, Wappenschmidt B, Wu AH, Ziogas A, Berchuck A and Risch HA for the Ovarian Cancer Association Consortium. Therole of KRAS rs61764370 in invasive epithelial ovarian cancer: implications for clinical testing. Clin Cancer Res 2011;17:3742-50. PMCID: PMC3107901.

Zeng H, Yu H, Lu L, Jain D, Kidd MS, Saif MW, Chanock SJ and Hartge P for the PanScan Consortium, Risch HA. Genetic effects and modifiers of radiotherapy and chemotherapy on survival in pancreatic cancer. Pancreas 2011;40:657-63. PMCID: PMC3116071.

Navarro Silvera SA, Mayne ST, Risch HA, Gammon MD, Vaughan T, Chow W-H, Dubin JA, Dubrow R, Schoenberg J, Stanford JL, West AB, Rotterdam H, Blot WJ. Principal component analysis of dietary and lifestyle patterns in relation to risk of subtypes of esophageal and gastric cancer. Ann Epidemiol 2011;21:543-50. PMCID: PMC3109225.

Lochhead P, Frank B, Hold GL, Rabkin CS, Ng MTH, Vaughan TL, Risch HA, Gammon MD, Lissowska J, Weck MN, Raum E, Müller H, Illig T, Klopp N, Dawson A, McColl KE, Brenner H, Chow WH, El-Omar EM. Genetic variation in the prostate stem cell antigen gene and upper gastrointestinal cancer in white individuals. Gastroenterology 2011;140:435-41. PMCID: PMC3031760.

Lochhead P, Ng MT, Hold GL, Rabkin CS, Vaughan TL, Gammon MD, Risch HA, Lissowska J, Mukhopadhya I, Chow W-H, El-Omar EM. Possible association between a genetic polymorphism at 8q24 and risk of upper gastrointestinal cancer. Eur J Cancer Prev 2011;20:54-7. PMCID: PMC3020097.

Zhou Y, Irwin ML, Risch HA. Pre- and post-diagnosis body mass index, weight change and ovarian cancer mortality. Gynecol Oncol 2011;140:435-41. PMCID: PMC3034401.

Bertuccio P, La Vecchia C, Silverman D, Petersen G, Bracci PM, Negri E, Li D, Risch HA, Olson SH, Gallinger S, Miller AB, Bueno-de-Mesquita HB, Talamini R, Polesel J, Ghadirian P, Baghurst PA, Zatonski W, Fontham E, Bamlet WR, Holly EA, Lucenteforte E, Hassan M, Yu

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H, Kurtz RC, Cotterchio M, Su J, Maisonneuve P, Duell EJ, Bosetti C, Boffetta P. Cigar and pipe smoking, smokeless tobacco use and pancreatic cancer: an analysis from the International Pancreatic Cancer Case-Control Consortium (PanC4). Ann Oncol 2011;22:1420-6. PMID:21245160. PMCID: PMC3139985.

Arem H, Irwin ML, Zhou Y, Lu L, Risch H, Yu H. Physical activity and endometrial cancer in a population-based case-control study. Cancer Causes Control 2011;22:219-26. PMCID:PMC3075067.

Soskolne CL, Jhangri GS, Scott HM, Brenner DR, Siemiatycki J, Lakhani R, Gérin M, Dewar R, Miller AB, Risch HA. A population-based case-control study of occupational exposure to acids and the risk of lung cancer: Evidence for specificity of association. Int J Occup Environ Health 2011;17:1-8. *Not a result of NIH funding.

2010Goode EL, Chenevix-Trench G, Song H, Ramus SJ, Notaridou M, Lawrenson K, Widschwendter

M, Vierkant RA, Larson MC, Kjaer SK, Birrer MJ, Berchuck A, Schildkraut J, Tomlinson I, Kiemeney LA, Cook LS, Gronwald J, Garcia-Closas M, Gore ME, Campbell I, WhittemoreAS, Sutphen R, Phelan C, Anton- Culver H, Pearce CL, Lambrechts D, Rossing MA, Chang- Claude J, Moysich KB, Goodman MT, Dörk T, Nevanlinna H, Ness RB, Rafnar T, Hogdall C, Hogdall E, Fridley BL, Cunningham JM, Sieh W, McGuire V, Godwin AK, Cramer DW, Hernandez D, Levine D, Lu K, Iversen ES, Palmieri RT, Houlston R, van Altena AM, Aben KKH, Massuger LFAG, Brooks-Wilson A, Kelemen LE, Le ND, Jakubowska A, Lubinski J, Medrek K, Stafford A, Easton DF, Tyrer J, Bolton KL, Harrington P, Eccles D, Chen A, Molina AN, Davila BN, Arango H, Tsai Y-Y, Chen Z, Risch HA, McLaughlin J, Narod SA, Ziogas A, Brewster W, Gentry-Maharaj A, Menon U, Wu AH, Stram DO, Pike MC, The Wellcome Trust Case-Control Consortium, Beesley J, Webb PM, The Australian Cancer Study (Ovarian Cancer), The Australian Ovarian Cancer Study Group, Chen X, Ekici AB, Thiel FC, Beckmann MW, Yang H, Wentzensen N, Lissowska J, Fasching PA, Despierre E, Amant F, Vergote I, Doherty J, Hein R, Wang-Gohrke S, Lurie G, Carney ME, Thompson PJ, Runnebaum I, Hillemanns P, Dürst M, Antonenkova N, Bogdanova N, Leminen A, Butzow R, Heikkinen T, Stefansson K, Sulem P, Besenbacher S, Sellers TA, Gayther SA, Pharoah PDP, The Ovarian Cancer Association Consortium (OCAC). A genome-wide association study identifies susceptibility loci for ovarian cancer at 2q31 and 8q24. Nat Genet 2010;42:874-9. PMCID: PMC3020231.

Ratner E, Lu L, Boeke M, Barnett R, Nallur S, Chin LJ, Pelletier C, Blitzblau R, Tassi R, Paranjape T, Hui P, Godwin AK, Yu H, Risch H, Rutherford T, Schwartz P, Santin A, Matloff E, Zelterman D, Slack FJ, Weidhaas JB. A KRAS-variant in ovarian cancer acts as a genetic marker of cancer risk. Cancer Res 2010;70:6509-15. PMCID: PMC2923587.

Cook MB, Kamangar F, Whiteman DC, Freedman ND, Gammon MD, Bernstein L, Brown LM, Risch HA, Ye W, Sharp L, Wu AH, Ward MH, Giffen C, Casson AG, Abnet CC, Murray LJ, Corley DA, Nyrén O, Vaughan TL, Chow W-H. Cigarette smoking and adenocarcinomas of the esophagus and esophagogastric junction: a pooled analysis from the International BEACON Consortium. J Natl Cancer Inst 2010;102:1344-53. PMCID: PMC2935475.

Risch HA, Yu H, Lu L, Kidd MS. ABO blood group, Helicobacter pylori seropositivity, and risk of pancreatic cancer: a case-control study. J Natl Cancer Inst 2010;102(7):502-5. PMCID: PMC2902822.

Johnatty SE, Beesley J, Chen X, Macgregor S, Duffy DL, Spurdle AB, deFazio A, Gava N, Webb PM, Rossing MA, Doherty JA, Goodman MT, Lurie G, Thompson PJ, Wilkens LR, Ness RB,

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Moysich KB, Chang-Claude J, Wang-Gohrke S, Cramer DW, Terry KL, Hankinson SE, Tworoger SS, Garcia-Closas M, Yang H, Lissowska J, Chanock SJ, Pharoah PD, Song H, Whitemore AS, Pearce CL, Stram DO, Wu AH, Pike MC, Gayther SA, Ramus SJ, Menon U, Gentry-Maharaj A, Anton-Culver H, Ziogas A, Hogdall E, Kjaer SK, Hogdall C, Berchuck A, Schildkraut JM, Iversen ES, Moorman PG, Phelan CM, Sellers TA, Cunningham JM, Vierkant RA, Rider DN, Goode EL, Haviv I, Chenevix-Trench G; Ovarian Cancer Association Consortium; Australian Ovarian Cancer Study Group; Australian Cancer Study (Ovarian Cancer). Evaluation of candidate stromal epithelial cross-talk genes identifies association between risk of serous ovarian cancer and TERT, a cancer susceptibility "hot-spot". PLoS Genet 2010;6:e1001016. PMCID: PMC2900295.

Elliott KS, Zeggini E, McCarthy MI, Gudmundsson J, Sulem P, Stacey SN, Thorlacius S, Amundadottir L, Grönberg H, Xu J, Gaborieau V, Eeles RA, Neal DE, Donovan JL, Hamdy FC, Muir K, Hwang SJ, Spitz MR, Zanke B, Carvajal-Carmona L, Brown KM; Australian Melanoma Family Study Investigators, Hayward NK, Macgregor S, Tomlinson IP, Lemire M, Amos CI, Murabito JM, Isaacs WB, Easton DF, Brennan P, PanScan Consortium, Barkardottir RB, Gudbjartsson DF, Rafnar T, Hunter DJ, Chanock SJ, Stefansson K, Ioannidis JP. Evaluation of association of HNF1B variants with diverse cancers: collaborative analysis of data from 19 genome-wide association studies. PLoS One 2010;5:e10858. PMCID: PMC2878330.

Petersen GM, Amundadottir L, Fuchs CS, Kraft P, Stolzenberg-Solomon RZ, Jacobs KB, Arslan AA, Bueno-de-Mesquita HB, Gallinger S, Gross M, Helzlsouer K, Holly EA, Jacobs EJ, Klein AP, LaCroix A, Li D, Mandelson MT, Olson SH, Risch HA, Zheng W, Albanes D, Bamlet WR, Berg CD, Boutron-Ruault M-C, Buring JE, Bracci PM, Canzian F, Clipp S, Cotterchio M, de Andrade M, Duell EJ, Gaziano JM, Giovannucci EL, Goggins M, Hallmans G, Hankinson SE, Hassan M, Howard B, Hunter DJ, Hutchinson A, Jenab M, Kaaks R, Kooperberg C, Krogh V, Kurtz RC, Lynch SM, McWilliams RR, Mendelsohn JB, Michaud DS, Parikh H, Patel AV, Peeters PHM, Rajkovic A, Riboli E, Rodriguez L, Seminara D, Shu X-O, Thomas G, Tjønneland A, Tobias GS, Trichopoulos D, Van Den Eeden SK, Virtamo J, Wactawski-Wende J, Wang Z, Wolpin B, Yu H, Yu K, Zeleniuch-Jacquotte A, Fraumeni JF Jr, Hoover RN, Hartge P, Chanock SJ. A genome-wide association study identifies pancreatic cancer susceptibility loci on chromosomes 13q22.1, 1q32.1 and 5p15.33. Nat Genet2010;42(3):224-8. PMCID: PMC28533179.

2009Song H, Ramus SJ, Tyrer J, Bolton K, Gentry-Maharaj A, Wozniak E, Anton-Culver H, Chang-

Claude J, Cramer DW, DiCioccio R, Dörk T, Goode EL, Goodman MT, Schildkraut JM, Sellers T, Beckmann MW, Beesley J, Blaakaer J, Carney ME, Chanock S, Chen Z, Cunningham JM, Dicks E, Doherty JA, Duerst M, Ekici AB, Fenstermacher D, Fridley BL, Gore ME, Hankinson SE, Hogdall C, Hogdall E, Iversen ES, Jacobs IJ, Jakubowska A, Lissowska J, Lubi ski J, Lurie G, McGuire V, McLaughlin J, M drek K, Moorman PG, Moysich K, Narod S, Phelan C, Risch H, Stram DO, Strick R, Terry KL, Tsai Y-Y, Tworoger SS, Van Den Berg DJ, Vierkant RA, Wang-Gohrke S, Webb PM, Wilkens LR, Wu AH, Yang H, Ziogas A, Australian Cancer (Ovarian) Study, The Australian Ovarian Cancer Study Group, The Hannover-Jena Ovarian Cancer Study Group, The Ovarian Cancer Association Consortium, Whittemore AS, Rossing MA, Ponder BAJ, Pearce CL, Ness RB, Menon U, Krüger Kjær S, Gronwald J, Garcia-Closas M, Fasching P, Easton DF, Chenevix-Trench G, Berchuck A, Pharoah PDP, Gayther SA. A genome-wide association study identifies a novel ovarian cancer susceptibility locus on 9p22.2. Nat Genet 2009;41:996-1000. PMCID:

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PMC2844110. Amundadottir L, Kraft P, Stolzenberg-Solomon RZ, Fuchs CS, Petersen GM, Arslan AA, Bueno-

de-Mesquita HB, Gross M, Helzlsouer K, Jacobs EJ, LaCroix A, Zheng W, Albanes D, Bamlet W, Berg CD, Berrino F, Bingham S, Buring JE, Bracci PM, Canzian F, Clavel-Chapelon F, Clipp S, Cotterchio M, de Andrade M, Duell EJ, Fox JW Jr, Gallinger S, Gaziano JM, Giovannucci E, Goggins M, González C, Hallmans G, Hankinson SE, Hassan M, Holly EA, Hunter DJ, Hutchinson A, Jackson R, Jacobs K, Jenab M, Kaaks R, Klein AP, Kooperberg C, Kurtz RC, Li D, Lynch SM, Mandelson M, McWilliams RR, Mendelsohn JB, Michaud DS, Olson SH, Overvad K, Patel AV, Peeters PHM, Rajkovic A, Riboli E, Risch HA, Shu X-O, Thomas G, Tobias GS, Trichopoulos D, Van Den Eeden SK, Virtamo J, Wactawski-Wende J, Wolpin BM, Yu H, Yu K, Zeleniuch-Jacquotte A, Chanock SJ, Hartge P, Hoover RN. Genome-wide association study identifies ABO blood group susceptibility variants for pancreatic cancer. Nat Genet 2009;41:986-90. PMCID: PMC2839871.

Hoyo C, Schildkraut JM, Murphy SK, Chow W-H, Vaughan TL, Risch H, Marks JR, Jirtle RL, Calingeart B, Mayne S, Fraumeni J Jr, Gammon MD. IGF2R polymorphisms and risk of esophageal and gastric adenocarcinoma. Int J Cancer 2009;125:2673-8. PMCID: PMC3008656.

Concato J, Jain D, Uchio E, Risch H, Li WW, Wells CK. Molecular markers and death fromprostate cancer. Ann Intern Med 2009;150:595-603. *Not a result of NIH funding.

Bentov Y, Brown TJ, Akbari MR, Royer R, Risch H, Rosen B, McLaughlin J, Sun P, Zhang S, Narod SA, Casper RF. Polymorphic variation of genes in the fibrinolytic system and the risk of ovarian cancer. PLoS ONE 2009;4:e5918. PMCID: PMC2691597.

Figueroa JD, Terry MB, Gammon MD, Vaughan TL, Risch HA, Zhang F-F, Kleiner DE, Bennett WP, Howe CL, Dubrow R, Mayne ST, Fraumeni JF Jr, Chow W-H. Cigarette smoking, body mass index, gastro-esophageal reflux disease, and non-steroidal anti-inflammatory drug use and risk of subtypes of esophageal and gastric cancers by P53 overexpression. Cancer Causes Control 2009;20:361-8. PMCID: PMC2726999.

Hold GL, Rabkin CS, Gammon MD, Berry SH, Smith MG, Lissowska J, Risch HA, Chow W-H, Mowat NAG, Vaughan TL, El-Omar EM. CD14-159C/T and TLR9-1237T/C polymorphisms are not associated with gastric cancer risk in Caucasian populations. Eur J Cancer Prev2009;18:117-9. PMCID: PMC2679029.

Metcalfe KA, Fan I, McLaughlin J, Risch HA, Rosen B, Murphy J, Bradley L, Armel S, Sun P, Narod SA. Uptake of clinical genetic testing for ovarian cancer in Ontario: a population-based study. Gynecol Oncol 2009;112:68-72. PMCID: PMC3074978.

2008Antoniou AC, Cunningham AP, Peto J, Evans DG, Lalloo F, Narod SA, Risch HA, Eyfjord JE,

Hopper JL, Southey MC, Olsson H, Johannsson O, Borg A, Pasini B, Radice P, Manoukian S, Eccles DM, Tang N, Olah E, Anton-Culver H, Warner E, Lubinski J, Gronwald J, Gorski B, Tryggvadottir L, Syrjakoski K, Kallioniemi O-P, Eerola H, Nevanlinna H, Pharoah PDP, Easton DF. The BOADICEA model of genetic susceptibility to breast and ovarian cancers: updates and extensions. Br J Cancer 2008;98:1457-66. PMCID: PMC2361716.

Navarro Silvera SA, Mayne ST, Risch H, Gammon MD, Vaughan TL, Chow W-H, Dubrow R, Schoenberg JB, Stanford JL, West AB, Rotterdam H, Blot WJ, Fraumeni JF Jr. Food group intake and risk of subtypes of esophageal and gastric cancer. Int J Cancer 2008;123:852-60. PMCID: PMC3008621.

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Vaninetti NM, Geldenhuys L, Porter GA, Risch H, Hainaut P, Guernsey DL, Casson AG. Inducible nitric oxide synthase, nitrotyrosine and p53 mutations in the molecular pathogenesis of Barrett’s Esophagus and esophageal adenocarcinoma. Mol Carcinog 2008;47:275-85. *Not a result of NIH funding.

Pearce CL, Wu AH, Gayther SA, Bale AE, Australian Cancer Study (Ovarian Cancer) and Australian Ovarian Cancer Study Group, Beck PA, Beesley J, Chanock S, Cramer DW, DiCioccio R, Edwards R, Fredericksen ZS, Garcia-Closas M, Goode EL, Green AC, Hartmann LC, Hogdall E, Kruger Kjaer S, Lissowska J, McGuire V, Modugno F, Moysich K, Ness RB, Ramus SJ, Risch HA, Sellers TA, Song H, Stram DO, Terry KL, Webb PM, Whiteman DC, Whittemore AS, Zheng W, Pharoah PDP, Chenevix-Trench G, Pike MC, Schildkraut J, Berchuck A, on behalf of the Ovarian Cancer Association Consortium (OCAC). Progesterone receptor variation and risk of ovarian cancer is limited to the invasive endometrioid subtype: results from the ovarian cancer association consortium pooled analysis. Br J Cancer2008;98:282-8. PMCID: PMC2361465.

Collaborative Group on Epidemiological Studies of Ovarian Cancer. Beral V, Doll R, Hermon C,Peto R, Reeves G. Ovarian cancer and oral contraceptives: collaborative reanalysis of data from 45 epidemiological studies including 23257 women with ovarian cancer and 87303 controls. Lancet 2008;371:303-14. *Not a result of NIH funding.

Harley I, Rosen B, Risch HA, Siminovitch K, Beiner ME, McLaughlin J, Sun P, Narod SA.Ovarian cancer risk is associated with a common variant in the promoter sequence of the mismatch repair gene MLH1. Gynecol Oncol 2008;109:384-7. PMCID: PMC3060029.

2007Terry MB, Gammon MD, Zhang FF, Vaughan TL, Chow W-H, Risch HA, Schoenberg JB,

Mayne ST, Stanford JL, West AB, Rotterdam H, Blot WJ, Fraumeni JF Jr, Santella RM. Alcohol dehydrogenase 3 and risk of esophageal and gastric adenocarcinomas. Cancer Causes Control 2007;18:1039-46.

Concato J, Jain D, Li WW, Risch HA, Uchio EM, Wells CK. Molecular markers and mortality in prostate cancer. BJU Intl 2007;100:1259-63.

Hold GL, Rabkin CS, Chow W-H, Smith MG, Gammon MD, Risch HA, Vaughan TL, McColl KEL, Lissowska J, Zatonski W, Schoenberg JB, Blot WJ, Mowat NAG, Fraumeni JF Jr, El-Omar EM. A functional polymorphism of Toll-like receptor 4 gene increases risk of gastric carcinoma and its precursors. Gastroenterology 2007;132:905-12.

Wideroff L, Vaughan TL, Farin FM, Gammon MD, Risch H, Stanford JL, Chow W-H. GST, NAT1, CYP1A1 polymorphisms and risk of esophageal and gastric adenocarcinomas. Cancer Detect Prev 2007;31:233-6.

Brokaw J, Katsaros D, Wiley A, Lu L, Su D, Sochirca O, de la Longrais IAR, Mayne S, Risch H,Yu H. IGF-I in epithelial ovarian cancer and its role in disease progression. Growth Factors 2007;25:346-54.

McLaughlin JR, Risch HA, Lubinski J, Moller P, Ghadirian P, Lynch H, Karlan B, Fishman D, Rosen B, Neuhausen SL, Offit K, Kauff N, Domchek S, Tung N, Friedman E, Foulkes W, Sun P, Narod SA, Hereditary Ovarian Cancer Clinical Study Group. Reproductive risk factors for ovarian cancer in carriers of BRCA1 or BRCA2 mutations: a case-control study. Lancet Oncol 2007;8:26-34.

Koutros S, Holford TR, Hahn T, Lantos PM, McCarthy PL Jr, Risch HA, Swede H. Excess diagnosis of non-Hodgkin’s lymphoma during spring in the USA. Leuk Lymphoma

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2007;48:357-66. 2006

Risch HA, McLaughlin JR, Cole DEC, Rosen B, Bradley L, Fan I, Tang J, Li S, Zhang S, Shaw PA, Narod SA. Population BRCA1 and BRCA2 mutation frequencies and cancer penetrances: a kin-cohort study in Ontario, Canada. J Natl Cancer Inst 2006;98(23):1694-706.

Risch HA, Bale AE, Beck PA, Zheng W. PGR +331A/G and increased risk of epithelial ovarian cancer. Cancer Epidemiol Biomarkers Prev 2006;15:1738-41.

Lu L, Katsaros D, Wiley A, Rigault de la Longrais IA, Risch HA, Puopolo M, Yu H. The relationship of insulin-like growth factor-II, insulin-like growth factor binding protein-3, and estrogen receptor-alpha expression to disease progression in epithelial ovarian cancer. Clin Cancer Res 2006;12:1208-14.

Mayne ST, Risch HA, Dubrow R, Chow W-H, Gammon MD, Vaughan TL, Borchardt L, Schoenberg JB, Stanford JB, West AB, Rotterdam H, Blot WJ, Fraumeni JF Jr. Carbonated soft drink consumption and risk of esophageal adenocarcinoma. J Natl Cancer Inst2006;98:72-5.

Beeghly A, Katsaros D, Chen H, Fracchioli S, Zhang Y, Massobrio M, Risch H, Jones B, Yu H. Glutathione S-transferase polymorphisms and ovarian cancer treatment and survival. GynecolOncol 2006;100:330-7.

2005Trivers KF, De Roos AJ, Gammon MD, Vaughan TL, Risch HA, Olshan AF, Schoenberg JB,

Mayne ST, Dubrow R, Stanford JL, Abrahamson P, Rotterdam H, West AB, Fraumeni JF Jr, Chow W-H. Demographic and lifestyle predictors of survival in patients with esophageal or gastric cancers. Clin Gastroenterol Hepatol 2005;3:225-30.

Antoniou AC, Pharoah PDP, Narod S, Risch HA, Eyfjord JE, Hopper JL, Olsson H, Johannsson O, Borg Å, Pasini B, Radice P, Manoukian S, Eccles DM, Tang N, Olah E, Anton-Culver H, Warner E, Lubinski J, Gronwald J, Gorski B, Tulinius H, Thorlacius S, Eerola H, Nevanlinna H, Syrjäkoski K, Kallioniemi O-P, Thompson D, Evans C, Peto J, Lalloo F, Evans DG, Easton DF. Breast and ovarian cancer risks to carriers of the BRCA1 5382insC and 185delAG and BRCA2 6174delT mutations: a combined analysis of 22 population based studies. J Med Genet 2005;42:602-3.

2004Gammon MD, Terry MB, Arber N, Chow W-H, Risch HA, Vaughan TL, Schoenberg JB, Mayne

ST, Stanford JL, Dubrow R, Rotterdam H, West AB, Fraumeni JF Jr, Weinstein IB, Hibshoosh, H. Nonsteroidal anti-inflammatory drug use associated with reduced incidence of adenocarcinomas of the esophagus and gastric cardia that overexpress Cyclin D1: a population-based study. Cancer Epidemiol Biomarkers Prev 2004;13:34-9.

2003Engel LS, Chow W-H, Vaughan TL, Gammon MD, Risch HA, Stanford JL, Schoenberg JB,

Mayne ST, Dubrow R, Rotterdam H, West AB, Blaser M, Blot WJ, Gail M, Fraumeni JF Jr. Population attributable risks of esophageal and gastric cancers. J Natl Cancer Inst2003;95:1404-13.

Risch HA. Etiology of pancreatic cancer, with a hypothesis concerning the role of N-nitroso compounds and excess gastric acidity. J Natl Cancer Inst 2003;95(13):948-60.

Fung WLA, Risch H, McLaughlin J, Rosen B, Cole D, Vesprini D, Narod SA. The N314D

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polymorphism of galactose-1-phosphate uridyl transferase does not modify the risk of ovarian cancer. Cancer Epidemiol Biomarkers Prev 2003;12:678-80.

Modugno F, Moslehi R, Ness RB, Nelson DB, Belle S, Kant JA, Wheeler JE, Wonderlick A, Fishman D, Karlan B, Risch H, Cramer DW, Dube M-P, Narod SA. Reproductive factors and ovarian cancer risk in Jewish BRCA1 and BRCA2 mutation carriers (United States). Cancer Causes Control 2003;14:439-46.

Modugno F, Ovarian Cancer and High-Risk Women Symposium Presenters. Ovarian cancer and high-risk women: Implications for prevention, screening, and early detection. Gynecol Oncol 2003;91:15-31.

El-Omar EM, Rabkin CS, Gammon MD, Vaughan TL, Risch HA, Schoenberg JB, Stanford JL, Mayne ST, Goedert J, Blot WJ, Fraumeni JF Jr, Chow W-H. Increased risk of noncardia gastric cancer associated with proinflammatory cytokine gene polymorphisms.Gastroenterology 2003;124:1193-201.

Antoniou A, Pharoah PDP, Narod S, Risch HA, Eyfjord JE, Hopper J, Loman N, Olsson H, Johannsson O, Borg Å, Pasini B, Radice P, Manoukian S, Eccles D, Tang N, Olah E, Anton-Culver H, Warner E, Lubinski J, Gronwald J, Gorski B, Tulinius H, Thorlacius S, Eerola H, Nevanlinna H, Syrjäkoski K, Kallionemi O-P, Thompson D, Evans C, Peto J, Lalloo F, Evans DG, Easton DF. Average risks of breast and ovarian cancer associated with BRCA1 or BRCA2mutations detected in case series unselected for family history: a combined analysis of 22 studies. Am J Human Genet 2003;72:1117-30.

2002Shaw PA, McLaughlin JR, Zweemer RP, Narod SA, Risch H, Verheijen RHM, Ryan A, Menko

FH, Kenemans P, Jacobs IJ. Histopathologic features of genetically determined ovarian cancer. Int J Gynecol Pathol 2002;21:407-11.

Engel LS, Vaughan TL, Gammon MD, Chow W-H, Risch HA, Dubrow R, Mayne ST, Rotterdam H, Schoenberg JB, Stanford JL, West AB, Blot WJ, Fraumeni JF Jr. Occupation and risk of esophageal and gastric cardia adenocarcinoma. Am J Ind Med 2002;42:11-22.

Ness RB, Cramer DW, Goodman MT, Kjaer SK, Mallin K, Mosgaard BJ, Purdie DM, Risch HA,Vergona R, Wu A. Infertility, fertility drugs and ovarian cancer: a pooled analysis of case-control studies. Am J Epidemiol 2002;155:217-24.

2001Dhillon PK, Farrow DC, Vaughan TL, Chow W-H, Risch HA, Gammon MD, Mayne ST,

Stanford JL, Schoenberg JB, Ahsan H, Dubrow R, West AB, Rotterdam H, Blot WJ, Fraumeni JF Jr. Family history of cancer and risk of esophageal and gastric cancers in the United States.Int J Cancer 2001;93:148-52.

Mayne ST, Risch HA, Dubrow R, Chow W-H, Gammon MD, Vaughan TL, Farrow DC, Schoenberg JB, Stanford JB, Ahsan H, West AB, Rotterdam H, Blot WJ, Fraumeni JF Jr. Nutrient intake and risk of subtypes of esophageal and gastric cancer. Cancer Epidemiol Biomarkers Prev 2001;10:1055-62.

Runnebaum IB, Wang-Gohrke S, Vesprini D, Kreienberg R, Lynch H, Moslehi R, Ghadirian P, Weber B, Godwin AK, Risch H, Garber G, Lerman C, Olipade OI, Foulkes WD, Karlan B, Warner E, Rosen B, Rebbeck T, Tonin P, Dubé M-P, Kieback DG, Narod SA. Progesterone receptor variant increases ovarian cancer risk in BRCA1 and BRCA2 mutation carriers who were never exposed to oral contraceptives. Pharmacogenetics 2001;11:1-4.

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Risch HA, McLaughlin JR, Cole DEC, Rosen B, Bradley L, Kwan E, Jack E, Vesprini DJ, Kuperstein G, Abrahamson JLA, Fan I, Wong B, Narod SA. Prevalence and penetrance of germline BRCA1 and BRCA2 mutations in a population series of 649 women with ovarian cancer. Am J Human Genet 2001;68(3):700-10.

2000Whiteman DC, Murphy MFG, Cook LS, Cramer DW, Hartge P, Marchbanks PA, Nasca PC, Ness

RB, Purdie DM, Risch HA. Multiple births and risk of epithelial ovarian cancer. J Natl Cancer Inst 2000;92:1172-7.

Moslehi R, Chu W, Karlan B, Fishman D, Risch H, Fields A, Smotkin D, Ben-David Y, Rosenblatt J, Russo D, Schwartz P, Tung N, Warner E, Rosen B, Friedman J, Brunet J-S, Narod SA. BRCA1 and BRCA2 mutation analysis of 208 Ashkenazi Jewish women with ovarian cancer. Am J Human Genet 2000;66:1259-72.

Shin HR, Kim JY, Ohno T, Cao K, Mizokami M, Risch H, Kim SR. Prevalence and risk factors of hepatitis C virus infection among Koreans in a rural area of Korea. Hepatol Res 2000;17:185-96.

Eras JL, Saftlas AF, Triche E, Hsu C-D, Risch HA, Bracken MB. Abortion and its effect on risk of preeclampsia and transient hypertension. Epidemiology 2000;11:36-43.

Farrow DC, Vaughan TL, Sweeney C, Gammon MD, Chow W-H, Risch HA, Stanford JL, Hansten PD, Mayne ST, Schoenberg JB, Rotterdam H, Ahsan H, West AB, Dubrow R, Fraumeni JF Jr, Blot WJ. Gastroesophageal reflux disease, use of H2 receptor antagonists, and risk of esophageal and gastric cancer. Cancer Causes Control 2000;11:231-8.

1999Wang-Gohrke S, Weikel W, Risch H, Vesprini D, Abrahamson J, Lerman C, Godwin A, Moslehi

R, Olipade O, Brunet J-S, Stickeler E, Kieback DG, Kreienberg R, Weber B, Narod SA, Runnebaum IB. Intron variants of the p53 gene are associated with increased risk for ovarian cancer but not in carriers of BRCA1 or BRCA2 germline mutations. Br J Cancer 1999;81:179-83.

Zweemer RP, Shaw PA, Verheijen RHM, Ryan A, Berchuk A, Ponder BAJ, Risch H,McLaughlin JR, Narod SA, Menko FH, Kenemans P, Jacobs IJ. Accumulation of p53 protein is frequent in ovarian cancers associated with BRCA1 and BRCA2 germline mutations. J Clin Pathol 1999;52:372-5.

1998Risch HA. Hormonal etiology of epithelial ovarian cancer, with a hypothesis concerning the role

of androgens and progesterone. J Natl Cancer Inst 1998;90(23):1774-86. Narod SA, Risch H, Moslehi R, Dørum A, Neuhausen S, Olsson H, Provencher D, Radice P,

Evans G, Bishop S, Brunet J-S, Ponder BAJ, Klijn JGM. Oral contraceptives and the risk of hereditary ovarian cancer. The Hereditary Ovarian Cancer Clinical Study Group. N Engl J Med 1998;339(7):424-8.

Vaughan TL, Farrow DC, Hansten PD, Chow W-H, Gammon MD, Risch HA, Stanford JL, Schoenberg JB, Mayne ST, Rotterdam H, Dubrow R, Ahsan H, West AB, Blot WJ, Fraumeni JF Jr. Risk of esophageal and gastric adenocarcinomas in relation to use of calcium channel blockers, asthma drugs, and other medications that promote gastroesophageal reflux. Cancer Epidemiol Biomarkers Prev 1998;7:749-56.

Chow W-H, Blaser MJ, Blot WJ, Gammon MD, Vaughan TL, Risch HA, Perez-Perez GI,

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Schoenberg JB, Stanford JL, Rotterdam H, West AB, Fraumeni JF Jr. An inverse relation between cagA+ strains of Helicobacter pylori infection and risk of esophageal and gastric cardia adenocarcinoma. Cancer Res 1998;58:588-90.

Farrow DC, Vaughan TL, Hansten PD, Stanford JL, Risch HA, Gammon MD, Chow W-H, Dubrow R, Ahsan H, Mayne ST, Schoenberg JB, West AB, Rotterdam H, Fraumeni JF Jr, Blot WJ. Use of aspirin and other non-steroidal anti-inflammatory drugs and risk of esophageal and gastric cancer. Cancer Epidemiol Biomarkers Prev 1998;7:97-102.

Chow WH, Blot WJ, Vaughan TL, Risch HA, Gammon MD, Stanford JL, Dubrow R, Schoenberg JB, Mayne ST, Farrow DC, Ahsan H, West AB, Rotterdam H, Niwa S, Fraumeni JF Jr. Body mass index and risk of adenocarcinomas of the esophagus and gastric cardia. J Natl Cancer Inst 1998;90:150-5.

1997Gammon MD, Schoenberg JB, Ahsan H, Risch HA, Vaughan TL, Chow W-H, Rotterdam H,

West AB, Dubrow R, Stanford JL, Mayne ST, Farrow DC, Niwa S, Blot WJ, Fraumeni JF Jr. Tobacco, alcohol, and socioeconomic status and adenocarcinomas of the esophagus and gastric cardia. J Natl Cancer Inst 1997;89:1277-84.

Chang S, Risch HA. Perineal talc exposure and risk of ovarian carcinoma. Cancer 1997;79:2396-401.

Yoo K-Y, Tajima K, Miura S, Takeuchi T, Hirose K, Risch H, Dubrow R. Breast cancer risk factors according to combined estrogen and progesterone receptor status: a case-control analysis. Am J Epidemiol 1997;146:307-14.

1996Risch HA. Estrogen replacement therapy and risk of epithelial ovarian cancer. Gynecol Oncol

1996;63:254-7. Risch HA, Marrett LD, Jain M, Howe GR. Differences in risk factors for epithelial ovarian

cancer by histologic type: results of a case-control study. Am J Epidemiol 1996;144(4):363-72.

1995Risch HA, Howe GR. Pelvic inflammatory disease and the risk of epithelial ovarian cancer.

Cancer Epidemiol Biomarkers Prev 1995;4:447-51. Risch HA, Howe GR. Menopausal hormone use and colorectal cancer in Saskatchewan: A record

linkage cohort study. Cancer Epidemiol Biomarkers Prev 1995;4:21-8. 1994

Risch HA, Jain M, Marrett LD, Howe GR. Dietary fat intake and risk of epithelial ovarian cancer. J Natl Cancer Inst 1994;86:1409-15.

Risch HA, Marrett LD, Howe GR. Parity, contraception, infertility and the risk of epithelial ovarian cancer. Am J Epidemiol 1994;140(7):585-97.

Risch HA, Jain M, Marrett LD, Howe GR. Dietary lactose intake, lactose intolerance, and the risk of epithelial ovarian cancer in southern Ontario (Canada). Cancer Causes Control 1994;5:540-8.

Narod SA, Madlensky L, Bradley L, Cole D, Tonin P, Rosen B, Risch HA. Hereditary and familial ovarian cancer in Southern Ontario. Cancer 1994;74:2341-6.

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Risch HA, Howe GR. Menopausal hormone usage and breast cancer in Saskatchewan: A record-linkage cohort study. Am J Epidemiol 1994;139:670-83.

1993Risch HA, Howe GR, Jain MJ, Burch JD, Holowaty EJ, Miller AB. Are female smokers at higher

risk for lung cancer than male smokers? A case-control analysis by histologic type. Am J Epidemiol 1993;138(5):281-93.

Holowaty PH, Miller AB, Baines CJ, Risch HA. Canadian National Breast Screening Study: First screen results as predictors of future breast cancer risk. Cancer Epidemiol Biomarkers Prev 1993;2:11-9.

Yoo K-Y, Tajima K, Miura S, Yoshida M, Murai H, Kuroishi T, Lee Y, Risch HA, Dubrow R. A hospital-based case-control study of breast-cancer risk factors by estrogen and progesterone receptor status. Cancer Causes Control 1993;4:39-44.

1991Holowaty EJ, Risch HA, Burch JD, Miller AB. Lung cancer in women in the Niagara region,

Ontario: A case-control study. Can J Publ Health 1991;82:304-9. 1990

Jain M, Burch JD, Howe GR, Risch HA, Miller AB. Dietary factors and risk of lung cancer: Results from a case-control study, Toronto, 1981-1985. Int J Cancer 1990;45:287-93.

1989Miller AB, Howe GR, Sherman GJ, Lindsay JP, Yaffe MJ, Dinner PJ, Risch HA, Preston DL.

Mortality from breast cancer after irradiation during fluoroscopic examinations in patients being treated for tuberculosis. N Engl J Med 1989;321:1285-9.

Burch JD, Rohan TE, Howe GR, Risch HA, Hill GB, Steele R, Miller, AB. Risk of bladder cancer by source and type of tobacco exposure: a case-control study. Int J Cancer 1989;44:622-8.

Howe GR, Burch JD, Chiarelli AM, Risch HA, Choi BCK. An exploratory case-control study of brain tumors in children. Cancer Res 1989;49:4349-52.

1988Risch HA, Burch JD, Miller AB, Hill GB, Steele R, Howe GR. Dietary factors and the incidence

of cancer of the urinary bladder. Am J Epidemiol 1988;127(6):1179-91. Risch HA, Burch JD, Miller AB, Hill GB, Steele R, Howe GR. Occupational factors and the

incidence of cancer of the bladder in Canada. Br J Ind Med 1988;45(6):361-7. Narod SA, Neri L, Risch HA, Raman S. Lymphocyte micronuclei and sister-chromatid

exchanges among Canadian federal laboratory employees. Am J Ind Med 1988;14:449-456. Risch HA, Weiss NS, Clarke EA, Miller AB. Risk factors for spontaneous abortion and its

recurrence. Am J Epidemiol 1988;128:420-30. Robles SC, Marrett LD, Clarke EA, Risch HA. An application of capture-recapture methods to

the estimation of completeness of cancer registration. J Clin Epidemiol 1988;41:495-501. 1987

Burch JD, Craib KJP, Choi BCK, Miller AB, Risch HA, Howe GR. An exploratory case-control study of brain tumors in adults. J Natl Cancer Inst 1987;78:601-9.

1986

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Baines CJ, Wall C, Risch HA, Kuin JK, Fan IJ. Changes in breast self-examination behaviour in a cohort of 8214 women in the Canadian National Breast Screening Study. Cancer 1986;57:1209-16.

Sclabassi RJ, Kroin JS, Hinman CL, Risch HA. The effect of cortical ablation on afferent activity in the cat somatosensory system. Electroenceph Clin Neurophysiol 1986;64:31-40.

1985Risch HA, Jain M, Choi NW, Fodor JG, Pfeiffer CJ, Howe GR, Harrison LW, Craib KJP,

Miller AB. Dietary factors and the incidence of cancer of the stomach. Am J Epidemiol 1985;122:947-59.

Sclabassi RJ, Hinman CL, Kroin JS, Risch HA. A non-linear analysis of afferent modulatoryactivity in the cat somatosensory system. Electroenceph Clin Neurophysiol 1985;60:444-54.

1983Risch HA, Weiss NS, Lyon JL, Daling JR, Liff JM. Events of reproductive life and the incidence

of epithelial ovarian cancer. Am J Epidemiol 1983;117(2):128-39. Risch HA. An approximate solution for the standard deterministic epidemic model. Math

Biosciences 1983;63:1-8. 1979

Risch HA. The correlation between relatives under assortative mating for an X-linked and autosomal trait. Ann Hum Genet 1979;43:151-65.

1977Sclabassi RJ, Risch HA, Hinman CL, Kroin JS, Enns NF, Namerow NS. Complex pattern evoked

somatosensory responses in the study of multiple sclerosis. Proc IEEE 1977;65:626-33.

Chapters in Books:

Holick CN, Risch HA. Smoking and Ovarian Cancer. In: Tobacco: Science, Policy and Public Health, second edition, Boyle P, Gray N, Henningfield J, Seffrin J, Zatonski W, eds. New York: Oxford University Press, pp. 503-11, 2010.

Holick CN, Risch HA. Smoking and Ovarian Cancer. In: Tobacco and Public Health: Scienceand Policy, Boyle P, Gray N, Henningfield J, Seffrin J, Zatonski W, eds. New York: Oxford University Press, pp. 511-21, 2004.

Risch HA. Hormones and Epithelial Ovarian Cancer. In: Proceedings of the Second International Symposium of the Portuguese Menopause Society, Neves-e-Castro M, Wren BG, eds. London, UK: Parthenon Publishing Group, pp. 129-40, 2002.

Risch HA. Etiologic Mechanisms in Epithelial Ovarian Cancer. In: Proceedings of the Third International Symposium on Hormonal Carcinogenesis, Li JJ, Daling JR, Li SA, eds. New York: Springer Verlag, pp. 307-19, 2000.

Howe GR, Burch JD, Risch HA. Artificial sweeteners, caloric intake and cancer: the epidemiologic evidence. In: Sweeteners: Health Effects, Williams G, ed. Princeton: Princeton Scientific Publishers, 1988.

Choi NW, Miller AB, Fodor JG, Jain M, Howe GR, Risch HA, Ruder AM. Consumption of precursors of N-nitroso compounds and human gastric cancer. In: The Relevance of N-Nitroso compounds to Human Cancer Exposures and Mechanisms, Bartsch H, O'Neill I, Schulte-

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Hermann R, eds. Lyon: IARC Scientific Publications No. 84, 1987.

Editorials and Other Invited Papers:

Risch HA. Diabetes and pancreatic cancer: both cause and effect. JNCI J Natl Cancer Inst 2019;111(1):djy093. doi: 10.1093/jnci/djy093

Risch HA. Pancreatic cancer: Helicobacter pylori colonization, N-nitrosamine exposures, and ABO blood group. Mol Carcinog 2012;51(1):109-18.

Risch HA. It’s time to accept that intake of dairy foods is not related to risk of ovarian cancer. Nat Clin Pract Oncol 2006;3:472-3.

Risch H. Involvement of dietary factors, Helicobacter pylori, and host inflammatory cytokine genetic polymorphisms in the etiology of pancreatic carcinoma. Zhong Liu [Tumor] 2003;23:445-7.

Risch HA. Postmenopausal estrogen-only, but not estrogen + progestin, was associated with an increased risk of ovarian cancer. Evid-Based Obstet Gynecol 2003;5:53-4.

Risch HA. Hormone replacement therapy and the risk of ovarian cancer. Gyn Oncol 2002; 86:115-7.

Other Papers:

Risch HA. THE AUTHOR REPLIES. Am J Epidemiol 2020;189(11):1444-1449. doi: 10.1093/aje/kwaa152. PMCID: PMC7454297 (letter)

Risch HA. Risch Responds to "How to Consider Low Reported Death Rates in COVID-19". Am J Epidemiol 2020;189(11):1230-1231. doi: 10.1093/aje/kwaa156. PMCID: PMC7454272 (letter)

Risch HA. Response to: "Overcoming the therapeutic nihilism of out-of-hospital management of COVID-19 patients". Am J Epidemio. 2020 Dec 16:kwaa275. doi: 10.1093/aje/kwaa275. Online ahead of print. PMCID: PMC7799246 (letter)

Connecticut Academy of Science and Engineering, Inc. (May 29, 2020). An Adaptive Risk-Based Strategy for Connecticut’s Ongoing COVID-19 Response [White Paper]. Retrieved from https://www.ctcase.org/reports/Adaptive%RiskBased%Approach.pdf

Risch HA. Re: NSAID use and pancreatic cancer risk. Gastroenterology 2018;155:931 (letter).Risch HA. Low-dose aspirin and pancreatic cancer risk—Reply. Cancer Epidemiol Biomarkers Prev

2017;26(7):1155-6 (letter).Risch HA. Aspirin and pancreatic cancer—Response. Cancer Epidemiol Biomarkers Prev

2017;26(6):979 (letter).Risch HA, Yu H, Lu L, Kidd MS. Risch et al. respond to “Clinical utility of prediction models for

rare outcomes: The example of pancreatic cancer.” Am J Epidemiol 2015;182(1):39-40.(response to invited commentary).

Risch HA, Berchuck A, Pharoah PDP for the Ovarian Cancer Association Consortium. KRASrs61764370 in epithelial ovarian cancer—Response. Clin Cancer Res 2011;17:6601 (letter).

Bertuccio P, La Vecchia C, Silverman DT, Petersen GM, Bracci PM, Negri E, Li D, Risch HA, Olson SH, Gallinger S, Miller AB, Bueno-de-Mesquita HB, Talamini R, Polesel J, Ghadirian P, Baghurst PA, Zatonski W, Fontham E, Bamlet WR, Holly EA, Lucenteforte E, Hassan M, Yu H, Kurtz RC, Cotterchio M, Su J, Maisonneuve P, Duell EJ, Bosetti C, Boffetta P. Reply to: Are

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cohort data on smokeless tobacco use and pancreatic cancer confounded by alcohol use? Ann Oncol 2011;22:1931-2. (letter).

Risch HA. Cyclin E Overexpression Relates to Ovarian Cancer Histology but Not to Risk Factors. Cancer Epidemiol Biomarkers Prev 2008;17:1841 (letter).

Zhang Y, Zhu Y, Risch HA. Changing incidence of thyroid cancer. JAMA 2006;296:1350 (letter).Mayne ST, Risch HA, Dubrow R, Chow W-H, Gammon MD, Vaughan TL, Fraumeni JF Jr.

Re: “Carbonated Soft Drink Consumption and Risk of Esophageal Adenocarcinoma.” Response. J Natl Cancer Inst 2006;98:646-7 (letter).

Risch HA, Miller AB. Re: “Are Women More Susceptible to Lung Cancer?” J Natl Cancer Inst 2004;96(20):1560 (letter).

Risch HA. Re: “Etiology of pancreatic cancer, with a hypothesis concerning the role of N-nitroso compounds and excess gastric acidity.” Response. J Natl Cancer Inst 2004;96:75-6 (letter).

Risch HA, Narod SA. Re: “Cancer risks in BRCA1 carriers: Time for the next generation of studies.” J Natl Cancer Inst 2003;95:758 (letter).

Risch HA, Narod SA. Re: “On the use of familial aggregation in population-based case probands for calculating penetrance.” J Natl Cancer Inst 2003;95:73-4 (letter).

Risch HA, Miller AB. Re: “Sex, smoking and cancer: a reappraisal.” J Natl Cancer Inst2002;94:308 (letter).

Narod SA, Sun P, Risch HA, for the Hereditary Ovarian Cancer Clinical Study Group. Ovarian cancer, oral contraceptives, and BRCA mutations. N Engl J Med 2001;345:1706-7 (letter).

Whiteman DC, Murphy MFG, Cook LS, Cramer DW, Hartge P, Marchbanks PA, Nasca PC, Ness RB, Purdie DM, Risch HA. Re: “Multiple births and risk of epithelial ovarian cancer--Response.” J Natl Cancer Inst 2001;93:319-20 (letter).

Risch HA. Oral contraceptive use, anovulatory action and risk of epithelial ovarian cancer. Epidemiology 2000;11:614 (letter).

Risch HA. Re: “Hormonal etiology of epithelial ovarian cancer, with a hypothesis concerning the role of androgens and progesterone.” Response. J Natl Cancer Inst 1999;91:650-1 (letter).

Risch HA. Re: “Relationship between lifetime ovulatory cycles and overexpression of mutant p53 in epithelial ovarian cancer.” J Natl Cancer Inst 1997;89:1726-7 (letter).

Risch HA, Howe GR, Jain MJ, Burch JD, Holowaty EJ, Miller AB. Re: “Are female smokers at higher risk for lung cancer than male smokers? A case-control analysis by histologic type”—The authors reply. Am J Epidemiol 1994;140:187-8 (letter).

Risch HA, Howe GR, Jain MJ, Burch JD, Holowaty EJ, Miller AB. Lung cancer risk for female smokers. Science 1994;263(5151):1206-8 (letter).

Risch HA. Re: “Likelihood-based Confidence Limits.” Ann Epidemiol 1992;2:767-9 (letter).Risch HA. Re: “A simple method to calculate the confidence interval of a standardized mortality

ratio (SMR).” Am J Epidemiol 1991;133:212 (letter). Risch HA. Re: “Risk factors for spontaneous abortion and its recurrence”—The first author

replies. Am J Epidemiol 1990;131:571-3 (letter).Miller AB, Risch HA. Diet and lung cancer. Chest--The Cardiopulmonary Journal 1989

(Suppl);96:8s-9s. Risch HA, Weiss NS, Daling JR, Lyon JL, Liff JM. Re: “Events of reproductive life and the

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incidence of epithelial ovarian cancer”—The authors reply. Am J Epidemiol 1989;129:862-3 (letter).

Risch HA, Tibshirani RJ. Likelihood-based conditional logistic regression methods for comparing different classes of controls under individual matching to a single case group. Am J Epidemiol 1988;128:446-8 (letter).

Risch HA. Book Review: Peter Taylor, The Smoke Ring: Tobacco, Money and Multinational Politics. J Public Health Policy 1985;6:137-139.

Risch HA. On approximate solutions for the general stochastic epidemic. Ph.D. dissertation, University of Chicago, 1980.

Risch HA. Functional power series analysis of somatosensory evoked potentials. M.D. dissertation, University of California at San Diego, 1976.

Published Abstracts:

Cartmel B, Hughes M, Zhou Y, Gottlieb L, Ercolano E, Risch H, Harrigan M, McCorkle R, Irwin M. Randomized trial of exercise on depressive symptoms in women diagnosed with ovarian cancer: The women's activity and lifestyle study in Connecticut (WALC). Psychooncology 2018;27(Suppl 1):97. doi:http://dx.doi.org/10.1002/pon.4623

Streicher SA, Klein AP, Olson SH, Kurtz RC, DeWan AT, Zhao H, Risch HA. A pooled genome-wide association study of pancreatic cancer susceptibility loci in American Jews. Cancer Res 2017;77(13 Suppl): Abstract 1326. doi:10.1158/1538-7445.AM2017-1326.

Rasmussen CB, Kjaer SK, Albieri V, Webb PM, Risch HA, Rossing MA, Goodman MT, Moysich KB, Schildkraut JM, Bandera EV, Massuger LFAG, Phelan C, Anton-Culver H, Pearce CL, Wu AH, Jensen A. Pelvic inflammatory disease and risk of invasive ovarian cancer and borderline ovarian tumors: A pooled analysis of 13 case-control studies. Int J Gynecol Obstet 2015;131(Suppl 5):e421.

Prastegaard C, Jensen A, Svane TS, Risch HA, Rossing MA, Chang-Claude J, Goodman MT, Moysich K, Matsuo K, Goode EL, Terry KL, Schildkraut JM, Massuger LFAG, Bandera EV, Wentzensen N, Whittemore A, Sutphen R, Anton-Culver H, Menon U, Gentry-Maharaj A, Wu A, Pearce CL, Webb PM, Kruger Kjaer S. The impact of cigarette smoking on ovarian cancer survival: A pooled analysis of 20 case control studies from the ovarian cancer association consortium. Int J Gynecol Obstet 2015;131(Suppl 5):e172.

Zhou Y, Gottlieb L, Cartmel B, Li F, Ercolano EA, Harrigan M, McCorkle R, Ligibel JA, Von Gruenigen VE, Gogoi R, Schwartz PE, Risch HA, Irwin ML. Randomized trial of exercise on quality of life and fatigue in women diagnosed with ovarian cancer: The Women's Activity and Lifestyle study in Connecticut (WALC). J Clin Oncol 2015;33(15 Suppl):9505.

Yang HP, Cook LS, Weiderpass E, Adami H-O, Anderson KE, Cai H, Cerhan JR, Clendenen T, Felix AS, Friedenreich C, Garcia-Closas M, Goodman MT, Liang X, Lissowska J, Lu L, Magliocco AM, McCann SE, Moysich KB, Olson SH, Pike MC, Polidoro S, Ricceri F, Risch H, Sacerdote C, Setiawan VW, Shu XO, Spurdle AB, Trabert B, Webb PM, Wentzensen N, Xiang Y-B, Xu Y, Yu H, Zeleniuch-Jacquotte A, Brinton LA. Infertility and risk of incident endometrial carcinoma: a pooled analysis from the Epidemiology of Endometrial Cancer Consortium. Cancer Res 2014;74(19 Suppl);2167.

Tang H, Duell EJ, Risch HA, Olson SH, Bueno-de-Mesquita HB, Gallinger S, Holly EA, Petersen GM, Bracci PM, McWilliams RR, Jenab M, Riboli E, Tjønneland A, Boutron-Ruault MC,

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Kaaks R, Trichopoulos D, Panico S, Sund M, Peeters PHM, Khaw K-T, Amos CI, Li D, Wei P. Genome-wide gene-diabetes and gene-obesity interaction scan in the pancreatic cancer case control consortium. Cancer Res 2014;74(19 Suppl);2214.

Irwin M, Gottlieb L, Cartmel B, Ercolano E, Rothbard M, Zhou Y, Schwartz PE, Ligibel JA, Von Gruenigen VE, Risch H. Trial of exercise in ovarian cancer survivors. J Clin Oncol 2012;30(suppl; abstr TPS1614).

Lu L, Katsaros D, Risch H, Yu H. Stem cell-associated gene Lin-28B genotype and phenotype in epithelial ovarian cancer and their associations with disease survival outcomes. Cancer Res 2012;72(8 Suppl);3655.

Risch HA. Why is pancreatic cancer less frequent in Asia than in the US, in spite of the higher prevalence of risk factors in Asia? Observations on the etiology of pancreatic cancer. J Epidemiol 2011;21(Suppl):43-6.

Berchuck A, Pharoah P, Ramus S, Gayther S, Palmieri R, Pearce C, Couch F, Antonio A, Goode E, Schildkraut J, Chenevix-Trench G, Sellers T, Risch H, for the Consortium of Investigators of Modifiers of BRCA1/2 and the Ovarian Cancer Association Consortium. Association of KRAS SNP rs61764370 with risk of invasive epithelial ovarian cancer: Implications for clinical testing. Gyn Oncol 2011;121:S2-3.

Tsai Y-Y, Chen YA, Chen Z, Permuth-Wey J, Iversen E, Risch H, Barnholtz-Sloan J, Cunningham JM, Vierkant RA, Fridley BL, Fenstermacher D, Sutphen R, Phelan CM, Narod SA, Schildkraut JM, Goode EL, Sellers TA. A novel region on 8q24.21 is associated with ovarian cancer susceptibility. Cancer Res 2011;70:4724. doi:10.1158/1538-7445.AM10-4724

Permuth-Wey J, Tsai Y-Y, Chen YA, Chen Z, Lancaster JM, Iverson E, Risch H, Barnholtz-Sloan J, Cunningham JM, Vierkant RA, Fridley BL, Fenstermacher D, Sutphen R, Narod SA, Goode EL, Schildkraut JM, Sellers TA, Phelan CM. Mitochondrial genetic variants influence ovarian cancer risk. Cancer Res 2011;70:2835. doi:10.1158/1538-7445.AM10-2835

Risch HA. Gene, environment, and risk factor interaction in pancreatic cancer. Cancer Prev Res 2010;3(12 Suppl):ED02-03. doi:10.1158/1940-6207.PREV-10-ED02-03

Ng MT, Rabkin CS, Lochhead P, Lissowska J, Vaughan TL, Gammon M, Risch H, Chow W-H, Hold GL, El-Omar E. Assessment of novel genetic polymorphisms and risk of upper gastrointestinal carcinoma. Gastroenterology 2010;138(5)(Suppl 1):S612.

Neale R, Whiteman D, Young J, Fritschi L, Fawcete J, Webb P, Risch H. The Queensland Pancreatic Cancer Study--Identifying risk factors for pancreatic cancer. Pancreas 2008;36:223.

Vaninetti N, Macdonald K, Geldenhuys L, Risch H, Porter G, Guernsey D, Casson AG. Nitric oxide in the molecular pathogenesis of Barrett Esophagus and esophageal adenocarcinoma. Gastroenterology 2007;132(Suppl 2):A635-6.

Engel LS, Vaughan TL, Gammon MD, Chow WH, Risch HA, Dubrow R, Mayne ST, Rotterdam H, Schoenberg JB, Stanford JL, West AB, Blot WJ, Fraumeni JF. Occupation and risk of esophageal and gastric cardia adenocarcinoma. Epidemiology 2002;13:S163.

Pharoah P, Antoniou A, Risch H, Narod S, Hopper J, Loman N, Olson H, Johansson O, Borg A, Pasini B, Radici P, Eccles D, Tang N, Olah E, Anton-Culver H, Eyfjord J, Evans DG, Evans C, Peto J, Easton D. Average risks of breast and ovarian cancer in women who carry a BRCA1 or BRCA2 mutation: a preliminary analysis of pooled family data from unselected case series. Am J Human Genet 2001;69 (Suppl 1):256.

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Ness RB, Cramer DW, Goodman M, Kjaer SK, Mosgaard B, Purdie DM, Risch H, Vergona R, Wu A. Infertility and ovarian cancer: A pooled analysis. Am J Epidemiol 2001;153:S111.

McLaughlin J, Cole D, Narod S, Rosen B, Risch H. Reproductive and genetic risk factors for ovarian cancer. Am J Epidemiol 2001;153:S205.

Lew EA, Risch HA, Chow WH, Gammon MD, Vaughan TL, Schoenberg JB, Stanford JL, West AB, Rotterdam H, Blot WJ, Blaser MJ, Fraumeni JF. Helicobacter pylori, gastroesophageal reflux, their interrelationships, and the risk of esophageal adenocarcinoma. Gastroenterology2001;120(Suppl 1):A31.

Lew EA, Risch HA, Chow WH, Gammon MD, Vaughan TL, Schoenberg JB, Stanford JL, Farrow D, West AB, Rotterdam H, Blot WJ, Fraumeni JF. Epidemiological study of risk factors for gastric carcinoids. Gastroenterology 2001;120(Suppl 1):A256.

El-Omar EM, Chow WH, Gammon MD, Vaughan TL, Risch HA, Fraumeni JF Jr. Pro-inflammatory genotypes of IL-1 beta, TNF-alpha and IL-10 increase risk of distal gastric cancer but not of cardia or oesophageal adenocarcinomas. Gastroenterology 2001;120(Suppl 1):A86.

Saftlas A, Wang W, Risch H, Woolson R, Hsu C, Bracken M. Prepregnancy body mass index and gestational weight gain as risk factors for preeclampsia and transient hypertension. Ann Epidemiol 2000;10:475.

Chu W, McLaughlin J, Phelan C, Cole D, Risch H, Narod S. The HRAS1 minisatellite locus increases the risk of ovarian cancer in BRCA1 carriers, but not in BRCA2 carriers or sporadic ovarian cancer. Am J Human Genet 2000;67:(Suppl 2):82.

Mayne ST, Risch H, Dubrow R, Chow W-H, Blot W, Gammon M, Vaughan T, Farrow DC, Schoenberg J, Stanford J, Ahsan H, Fraumeni JF Jr. Nutrient intake and risk of adenocarcinomas of the esophagus and gastric cardia. FASEB J 1999;13:A1021.

Hibshoosh H, Gammon MD, Rotterdam H, West AB, Terry MB, Vaughan TL, Risch HA, Chow WH, Fraumeni J, Arber N. Cyclin D1 overexpression in esophageal and gastric carcinoma: Correlation with histopathology. Lab Invest 1999;79:76A.

Shaw PA, Zweemer RP, McLaughlin J, Narod SA, Risch H, Jacobs IJ. Characteristics of genetically determined ovarian cancer. Lab Invest 1999;79:124A.

Farrow DC, Vaughan TL, Sweeney C, Gammon MD, Chow W-H, Risch HA, Stanford JL, Hansten PD, Mayne ST, Schoenberg JB, Rotterdam H, Ahsan H, West AB, Dubrow R, Fraumeni JF Jr, Blot WJ. Gastroesophageal reflux disease, use of H2 receptor antagonists, and risk of esophageal and gastric cancer. Ann Epidemiol 1998;8:456.

Farrow DC, Vaughan TL, Hansten PD, Stanford JL, Risch HA, Gammon MD, Chow W-H, Dubrow R, Ahsan H, Mayne ST, Schoenberg JB, West AB, Rotterdam H, Fraumeni JF Jr, Blot WJ. Use of aspirin and other non-steroidal anti-inflammatory drugs and risk of esophageal and gastric cancer. Ann Epidemiol 1998;8:134.

Chow WH, Blot WJ, Vaughan TL, Risch HA, Gammon MD, Farrow DC, Mayne ST, Schoenberg JB, Fraumeni JF Jr. Body mass index and risk of adenocarcinomas of the esophagus and gastri cardia. Cancer Epidemiol Biomarkers Prev 1998;7:175.

Vaughan T, Farrow D, Chow W-H, Gammon M, Risch H, Hansten P, Schoenberg J, Mayne S, Fraumeni J Jr. Risk of esophageal and gastric adenocarcinoma and use of calcium antagonists and other medications that promote gastroesophageal reflux. Cancer Epidemiol Biomarkers Prev 1998;7:178.

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Chow WH, Blaser MJ, Blot WJ, Gammon MD, Vaughan TL, Risch HA, Pérez-Pérez GI, Fraumeni JF Jr. H. pylori and CagA status in relation to risk of adenocarcinomas of esophagus and stomach by anatomic subsite. Gut 1997;41(Suppl):A33-4.

Abrahamson JLA, Vesprini DJ, Mclaughlin J, Cole D, Rosen B, Bradley L, Robb K, Jack E, Rehal P, Morris A, Patterson C, Fan I, Brunel JS, Narod SA, Risch HA. High proportion of germline BRCA1 and BRCA2 mutations in unselected ovarian cancer. Am J Human Genet 1997;61(Suppl):A59.

Risch HA. Estrogen replacement therapy and the risk of epithelial ovarian cancer. Am J Epidemiol 1996;143:S42.

Risch HA, Howe GR. Pelvic inflammatory disease and the risk of epithelial ovarian cancer. Am J Epidemiol 1995;141:S24.

Risch HA, Jain M, Marrett LD, Howe GR. Dietary fat intake and the risk of epithelial ovarian cancer. Am J Epidemiol 1994;139:S37.

Klaus D, Dubrow R, Risch H, Troncale F. Risk of colorectal adenomas and use of nonsteroidal antiinflammatory drugs (NSAIDS) and acetaminophen (APAP). Am J Epidemiol 1994;139:S78.

Risch HA, Malcolm E, Howe GR. Cohort study of menopausal hormone usage and breast cancer in Saskatchewan. Am J Epidemiol 1993;138:610.

Risch HA, Howe GR, Jain MJ, Burch JD, Holowaty EJ, Miller AB. Are female smokers at higher risk for lung cancer than male smokers? A case-control analysis by histologic type. Am J Epidemiol 1992;136:1015.

Risch HA. A unified framework for meta-analysis by maximum likelihood. Am J Epidemiol 1988;128:906.

Risch HA. Measuring tumor induction period in case-control studies of chronic exposures. Am J Epidemiol 1986;124:499.

Research Grants Held:

2020-2025 AP Klein (Principal Investigator), G Petersen, D Li, HA Risch, P Bracci, S Gallinger, R Hung, M Meng, E Jacobs, J Manjer, M Sund, V Katzke, A Arslan, L Le Marchand, R Milne, R Stolzenberg-Solomon, C Kooperberg, S van den Eeden, J Genkinger, A Schwartz, J Brody, S Lynch, A Tjønneland, X-O Shu, L Amundadottir, K Visvanathan, B Wolpin. Multi-Ancestry Mapping of Pancreatic Cancer Susceptibility Loci.(National Cancer Institute, $112,843 total direct costs to Yale subcontract over 60 months)

2018-2020 CY Jeon (Principal Investigator), S Freedland, S Kim, NY Kyeong, TK Nuckols, SJ Pandol, HA Risch, B Spiegel. Predicting the Diagnosis of Pancreatic Cancer by Leveraging Big Data. (National Cancer Institute, $235,000 total direct costs over 24 months)

2018-2018 ML Irwin (Principal Investigator), L Lu, H Risch. Impact of exercise and diet-induced weight loss on immunosuppression in breast cancer survivors. (Cynthia Barnett Breast Cancer Foundation, $25,000 total costs over 12 months)

2017-2018 HA Risch (Principal Investigator), L Lu. Feasibility of circulating exosomal proteins in ovarian cancer diagnosis. (Brozman Ovarian Cancer Foundation, $25,000 total

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costs over 12 months) 2016-2021 AP Klein (Principal Investigator), P Bracci, S Cleary, S Gallinger, R Hung, D Li, R

Neale, S Olson, G Petersen, HA Risch, G Scelo. Validation and Fine-scale Mapping of Pancreatic Cancer Susceptibility Loci. (National Cancer Institute, $220,000 total direct costs to Yale subcontract over 60 months)

2013-2017 Y Guan, X Ma (Principal Investigators), D Zimmerman, P Diggle, T Holford, H Risch,L Mueller, Y Zhang. New Statistical Methods to Handle Spatial Uncertainty in Cancer Risk Estimation. (National Cancer Institute, $1,100,000 total direct costs over 48 months)

2011-2016 R Kurman (Principal Investigator), H Berman, L Cope, T Diaz-Montes, M Gauthier, D Huso, D Levine, E Matloff, S Narod, V Parkash, H Risch, G Rosner, P Shaw, I-MShih, R Soslow, R Vang, K Visvanathan, T-L Wang, et al. Prevention of Ovarian High-Grade Serous Carcinoma by Elucidating Its Early Changes. (Department of Defense USMRMC, $9,166,162 total direct costs, of which $199,000 total direct to Yale epidemiology subcontract, over 60 months).

2011-2015 AP Klein (Principal Investigator), P Bracci, P Brennan, E Duell, S Gallinger, D Li, R Neale, S Olson, G Petersen, HA Risch. Validation and Fine-scale Mapping of Pancreatic Cancer Susceptibility Loci. (National Cancer Institute, $197,000 total direct costs to Yale subcontract over 48 months)

2011-2013 AP Klein, HA Risch (Co-Principal Investigators). Validation and Fine-Scale Mapping of Pancreatic Cancer Susceptibility Loci. (National Human Genome Research Institute, covers costs of large-scale high-throughput genotyping of collaborative multi-center pancreatic cancer study (see previous grant) at the Center for Inherited Disease Research (CIDR)).

2010-2016 H Yu (Principal Investigator), M Irwin, X Ma, S Mayne, H Risch, H Zhao, J Lim.Epidemiologic Study of Hepatocellular Carcinoma in the US. (National Cancer Institute, $5,385,000 total direct costs over 60 months)

2010-2014 T Sellers (Principal Investigator), A Berchuck, G Bloom, M Clyde, D Fenstermacher, B Fridley, S Gayther, W Ge, E Goode, E Iversen, H-Y Lin, S Mears, A Monteiro, T Moorman, L Pearce, P Pharoah, C Phelan, H Risch, MA Rossing, J Schildkraut, GTrench, Y-Y Tsai. Follow-up of Ovarian Cancer Genetic Association and Interaction Studies (FOCI). (National Cancer Institute, $108,926 total direct costs to Yale subcontract 2012-2014)

2010-2013 CL Pearce (Principal Investigator), JA Doherty, S Gayther, VM McGuire, H Risch,MA Rossing, J Schildkraut, TA Sellers, W Sieh, D Stram, G Trench, P Webb, A Whittemore, A Wu. Identifying Ovarian Cancer Susceptibility Alleles Using Genome-Wide Scan Data. (National Cancer Institute, $22,500 total direct costs to Yale subcontract)

2009-2014 M Irwin (Principal Investigator), J Dziura, R McCorkle, G Mor, H Risch, P Schwartz, H Yu. Impact of Exercise on Ovarian Cancer Prognosis. (National Cancer Institute, $2,045,493 total direct costs over 59 months)

2009-2012 T Vaughan, D Whiteman (Principal Investigators), L Bernstein, D Corley, MD Gammon, L Hardie, N Hayward, G Liu, L Murray, O Nyrén, U Peters, B Reid, HA Risch, Y Romero, N Shaheen, D Stram, D Van Den Berg, B Weir, A Wu. Barrett’s and Esophageal Adenocarcinoma Consortium Genetic Susceptibility Study. (National

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Cancer Institute, $3,750,000 total direct costs over 36 months) 2009-2010 M Goodman (Principal Investigator), A Berchuck, J Chang-Claude, D Cramer, CM

Garcia, E Goode, S Krueger Kjaer, R Ness, P Pharoah, HA Risch, M Rossing, R Sutphen, K Terry, G Trench, A Whittemore. Collaborative Genetic Study of Ovarian Cancer Risk. (National Cancer Institute, $17,419 total direct costs over 12 months, to Yale subcontract)

2007-2014 HA Risch (Principal Investigator), Y-T Gao, MS Kidd, H Yu. Case-Control Study of Pancreas Cancer in Shanghai, China. (National Cancer Institute, $1,858,377 total direct costs over 75 months)

2007-2012 P Salovey (Principal Investigator), M Irwin, ST Mayne, HA Risch. Promoting Cancer Prevention/Control with Message Framing: III. Extending Tailored Cancer Information Service-Delivered Messages Across the Cancer Continuum. (National Cancer Institute: $1,525,215 total direct costs over 58 months)

2007-2012 R Neale (Principal Investigator), D Whiteman, J Young, L Fritschi, J Fawcett, P Webb, H Risch. Case-Control Study of Genetic and Environmental Risk Factors forPancreatic Carcinoma. (National Health and Medical Research Council (Australia): AU$946,475 total nonacademic direct costs over 60 months)

2007-2011 T Sellers (Principal Investigator), D Ballinger, J Barnholtz-Sloan, ME Colter, Y Huang, E Iversen, J Lancaster, J McLaughlin, S Narod, VS Pankratz, H Risch, J Schildkraut, R Sutphen. Haplotype-Based Genome Screen for Ovarian Cancer Loci.(National Cancer Institute, $5,726,016 total direct costs over 60 months)

2006-2007 R Neale (Principal Investigator), D Whiteman, L Fritschi, J Young, J Fawcett, P Webb, H Risch. A Case-Control Study of the Environmental and Genetic Causes of Pancreatic Carcinoma. (Queensland Cancer Fund: AU$258,339 total nonacademic direct costs over 16 months)

2003-2012 HA Risch (Principal Investigator), FS Gorelick, D Jain, MS Kidd, ST Mayne, MD Topazian, H Yu. Case-Control Study of Pancreas Cancer Etiologic Factors.(National Cancer Institute: $2,578,672 total direct costs over 80 months, in NCE)

2003-2010 H Yu (Principal Investigator), HA Risch, ST Mayne, M Irwin, B Cartmel. Role of Genetic and Lifestyle Interplay in Uterus Cancer. (National Cancer Institute: $2,185,432 total direct costs over 60 months, in NCE)

2003-2006 SA Narod (Principal Investigator), B Rosen, JR McLaughlin, P Shaw, HA Risch. The contribution of BRCA2 to ovarian cancer. (National Cancer Institute of Canada: $375,000 total nonacademic direct costs over 36 months)

2002-2005 H Yu (Principal Investigator), HA Risch. DNA Methylation, Aging, and Prostate Cancer Risk. (National Cancer Institute: $600,000 total direct costs over 48 months)

2002-2006 JP Concato (Principal Investigator), W Li, P Peduzzi, HA Risch, D Jain. Risk of Mortality in Prostate Cancer. (USVA: $424,000 total direct costs over 48 months)

2001-2007 P Salovey (Principal Investigator), HA Risch, ST Mayne, M Morra. Promoting Cancer Prevention/Control with Message Framing. II. (National Cancer Institute: $1,324,481 total direct costs over 72 months)

1999-2005 HA Risch (Principal Investigator), AE Bale. DNA Polymorphisms in Ovarian Cancer: Case-Control Study. (National Cancer Institute: $325,168 total direct costs over 58months)

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1998-2002 JP Concato (Principal Investigator), W Li, P Peduzzi, S Flynn, C Howe, HA Risch, D Esrig. Risk of Mortality in Prostate Cancer. (USVA: $425,245 total direct costs over 48 months)

1997-2003 HA Risch (Principal Investigator), L DiPietro, AF Saftlas, A Duleba, ML Carcangiu. Case-Control Study of Ovarian Cancer Hormonal Etiology. (National Cancer Institute: $1,445,806 total direct costs over 70 months)

1997-2000 SA Narod (Principal Investigator), HA Risch. Risk-Factor Analysis of BRCA1 and BRCA2 Carriers. (National Cancer Institute: $1,228,000 total direct costs over 36 months)

1997-2001 P Salovey (Principal Investigator), HA Risch, M Morra. Promoting Cancer Prevention/Control with Message Framing. (National Cancer Institute: $498,295 total direct costs over 48 months)

1996-1999 P Salovey (Principal Investigator), HA Risch, M Morra. Message Framing, Persuasion, and Cancer Prevention/Detection. (American Cancer Society: $198,000 total direct costs over 24 months)

1994-2000 HA Risch (Principal Investigator), JR McLaughlin, SA Narod, NJ Risch, EJ Holowaty, BP Rosen, DEC Cole. Genetic-Epidemiology Study of Epithelial Ovarian Tumors.(National Cancer Institute: $799,551 total direct costs over 69 months)

1994-1997 SA Narod (Principal Investigator), HT Lynch, HA Risch, DE Goldgar. The Prevention of Hereditary Breast and Ovarian Cancer. (National Cancer Institute: $356,875 total direct costs over 34 months)

1992-1996 HA Risch (Principal Investigator), ST Mayne, R Dubrow, AB West. Epidemiologic Study of Esophageal/Gastric Adenocarcinoma. (National Cancer Institute: $536,163 total direct costs over 43 months)

1991-1992 HA Risch (Principal Investigator). Latency-Temporality Analysis in Case-Control Studies of Chronic Exposures. (National Institutes of Health (BSRG): $19,000 total direct costs over 12 months)

1990-1991 HA Risch (Principal Investigator), GR Howe, R West, LM Strand. A Record-Linkage Cohort Study of Menopausal Hormone Usage and Endometrial Cancer in Saskatchewan. (National Health Research and Development Program, Health and Welfare Canada: $50,476 total nonacademic direct costs over 8 months)

1990-1994 JAJ Stolwijk (Principal Investigator), HA Risch, ST Mayne, R Dubrow, T Holford. Cancer Prevention Research Unit for Connecticut at Yale. (National Cancer Institute: $3,865,000 total direct costs over 60 months)

1989-1993 HA Risch (Principal Investigator), LD Marrett, GR Howe, M Jain. A Case-Control Study of Dietary Factors and Epithelial Ovarian Cancer. (National Health Research and Development Program, Health and Welfare Canada: $343,766 total nonacademic direct costs over 41 months)

1986-1990 GR Howe (Principal Investigator), HA Risch, M Jain, JD Burch, C Wall. Research Project Support of the NCIC Epidemiology Unit. (National Cancer Institute of Canada: total nonacademic direct costs $228,093 in 1986-7; $440,454 in 1987-8; $205,617 in 1988-9, etc.)

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Selected Scholarly Presentations and Workshops:

11/20 “Randomized Controlled Trials, Hydroxychloroquine and Risk of Hospitalization and Mortality in Patients with Covid-19.” Testimony, US Senate Committee on Homeland Security & Governmental Affairs, Washington, DC.

5/19 “Pancreatic Cancer and Diet.” Pancreatic Cancer Case-Control Consortium (PanC4) Annual Meeting, Baltimore, MD.

3/19 “Reducing Mortality of What Will Be the #3 Cause of Cancer Death Two Years from Now.” Virus and Other Infection-associated Cancers Research Seminar, Yale School of Medicine, New Haven, CT.

5/18 “New Concepts in Causation.” Keynote speaker, Pancreatic Cancer Case-Control Consortium (PanC4) Annual Meeting, Baltimore, MD.

2/18 "Risk Factors for Pancreatic Cancer." Yale Pancreas Symposium 2018: Multidisciplinary Management of Pancreatic Cancer. New Haven, CT.

4/17 “Reducing Mortality of what will be the #2 Cause of Cancer Death Four Years from Now.” Gastroenterologic Oncology Service, Yale Cancer Center, New Haven, CT.

3/17 “Genomewide Association Study of Pancreatic Cancer in American Jews.” Pancreatic Cancer Case-Control Consortium (PanC4) Annual Meeting, Baltimore, MD.

3/17 “New Markers and Approaches in Predicting Risk of Pancreatic Cancer.” Pancreatic Cancer Case-Control Consortium (PanC4) Annual Meeting, Baltimore, MD.

12/16 “Genomewide Association Study of Pancreatic Cancer in American Jews.” Pancreatic Cancer Case-Control Consortium (PanC4) GWAS Study Annual Meeting, Bethesda, MD.

10/16 “Reducing Mortality of Pancreatic Cancer in the International Context.” Inaugural Global Oncology Seminar Series speaker, Yale Cancer Center, New Haven, CT.

6/16 “Prevention of Pancreatic Cancer.” Pancreatic Cancer Case-Control Consortium (PanC4) Annual Meeting, Milan, Italy.

1/16 “Reducing Mortality of what will be the #2 Cause of Cancer Death Five Years from Now.” Department of Therapeutic Radiation, Yale School of Medicine, New Haven, CT.

10/15 “Reducing Mortality of what will be the #2 Cause of Cancer Death Five Years from Now.” Division of Cancer Epidemiology and Genetics, National Cancer Institute, NIH, Rockville, MD.

3/15 “Absolute Risk Models for Pancreatic Cancer.” Pancreatic Cancer Case-Control Consortium (PanC4) Annual Meeting, Baltimore, MD.

12/12 Keynote Speaker, “From Cancer Registration to Cancer Etiology to Cancer Prevention.” Cancer Registrars Association of New England Annual Meeting,Norwich, CT.

3/12 “Pancreatic Cancer Risk Models.” Pancreatic Cancer Case-Control Consortium (PanC4) Annual Meeting, Baltimore, MD.

3/12 Cancer Center Grand Rounds: “Helicobacter pylori, ABO Blood Group and the Etiology of Pancreatic Cancer in China and the US.” Yale University School of Medicine, New Haven, CT.

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9/11 “Etiology of Pancreatic Cancer: Theory and Evidence.” Seminar, Division of Chronic Disease Epidemiology, Yale University School of Public Health, New Haven, CT.

3/11 “Genetic Effects and Modifiers of Radiotherapy and Chemotherapy on Survival in Pancreatic Cancer,” Pancreatic Cancer Case-Control Consortium (PanC4) Annual Meeting, New York, NY.

1/11 Keynote Speaker, “Why is Pancreatic Cancer Less Frequent in Asia than in the US, in Spite of the Higher Prevalence of Risk Factors in Asia? Observations on the Etiology of Pancreatic Cancer.” Japan Epidemiology Association National Meetings, Sapporo, Japan.

1/11 Department Seminar: “BRCA1 and BRCA2 Mutations: Population Frequencies and Associations with a Variety of Cancers.” Division of Epidemiology and Prevention, Aichi Cancer Center Research Institute, Nagoya, Japan.

1/11 Cancer Center Grand Rounds, “Why is Pancreatic Cancer Less Frequent in Asia than in the US, in Spite of the Higher Prevalence of Risk Factors in Asia? Observations on the Etiology of Pancreatic Cancer.” Japan National Cancer Center, Tokyo, Japan.

11/10 Educational Session Seminar, “Gene, environment, and risk-factor interaction in pancreatic cancer.” AACR Frontiers in Cancer Prevention Annual International Meeting, Philadelphia PA.

11/10 Workshop Presentation: “KRAS variation and risk of ovarian cancer.” Biennial meeting of the Ovarian Cancer Association Consortium (OCAC), Bethesda, MD.

5/10 Cancer Center Retreat Seminar, “ABO blood group, Helicobacter pylori colonization and pancreatic cancer.” Yale University School of Medicine, New Haven, CT.

3/10 “Helicobacter pylori colonization, ABO blood group and risk of pancreatic cancer,” Pancreatic Cancer Case-Control Consortium (PanC4) Annual Meeting, Bethesda, MD.

7/09 Epidemiology Grand Rounds: “Pancreas Cancer and Helicobacter pylori in the U.S. and China.” Department of Epidemiology, Shanghai Cancer Institute, Shanghai, China.

3/09 Cancer Center Grand Rounds: “Inconsistencies in Pancreas-Cancer Risk Factors and Disease Incidence Between the U.S. and China: Observations on the Etiology of Pancreas Cancer.” Yale University School of Medicine, New Haven, CT.

11/08 Workshop Participant, Defining the Public Health Research Agenda for Ovarian Cancer, Centers for Disease Control, Atlanta, GA.

7/08 Workshop Presentation: “Helicobacter pylori and pancreas cancer.” Biological and Clinical Risks and Potential Benefits of Helicobacter pylori Colonization, Division of Microbiology and Infectious Diseases, NIAID, NIH, Bethesda, MD.

1/08 Research Seminar: “Smoking and lung cancer in women—yet again.” Program in Cancer Prevention and Control, Yale Cancer Center, New Haven, CT.

11/07 Workshop Presentation: “BRCA1 and BRCA2 Mutations: Frequencies in the General Population of North America and Associations with Breast, Ovary, Stomach, Pancreas and Other Cancers.” Nanjing International Symposium of New Frontiers in Cancer Research and Advanced Training Workshop of Cancer Molecular Epidemiology, Nanjing Medical University, Nanjing, China.

10/07 Workshop Presentation: “Why have epidemiology data and outcomes of clinical trials

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not correlated?” Third Haifa Cancer Prevention Workshop. CHS National Cancer Control Center, Faculty of Medicine, Technion Israel Institute of Technology, Haifa, Israel.

6/07 Workshop: “Advanced Statistical Methods for Epidemiologic Studies”. Department of Community Medicine and Epidemiology, Technion Israel Institute of Technology Faculty of Medicine, Haifa, Israel.

3/07 Ruth and Bruce Rappaport Seminar: “Why Pancreas Cancer is Less Frequent in China than the US, in Spite of the Generally Higher Chinese Prevalence of Risk Factors: Insights on the Etiology of Pancreas Cancer.” Faculty of Medicine, Technion Israel Institute of Technology, Haifa, Israel.

2/07 Seminar: “Smoking and lung cancer in women—yet again.” Department of Community Medicine and Epidemiology, Technion Israel Institute of Technology Faculty of Medicine, Haifa, Israel.

1/07 Seminar: “Etiologic theories for epithelial ovarian cancer.” Department of Community Medicine and Epidemiology, Technion Israel Institute of Technology Faculty of Medicine, Haifa, Israel.

11/06 Seminar: “BRCA1 and BRCA2 Mutations: Frequencies in the General Population and Associations with Breast, Ovary, Stomach, Pancreas and Other Cancers.” New York University Cancer Center, New York, NY.

2/06 Cancer Center Grand Rounds: “BRCA1 and BRCA2 Mutations: Their Frequencies in the General Population and Their Associations with Breast, Ovary, Stomach, Pancreas and Other Cancers,” Yale University School of Medicine, New Haven, CT.

11/05 Symposium: "Why Pancreas Cancer is Less Frequent in China than the US, in spite of the Generally Higher Chinese Prevalence of Risk Factors: Insights on the Etiology of Pancreas Cancer." Clinical Oncological Society of Australia annual scientific meeting, Brisbane, Australia (Sponsored by the Queensland Cancer Fund).

11/05 Symposium: "Risks and penetrances of germline BRCA1 and BRCA2 mutations for ovarian, breast, stomach, pancreas and other cancers: updated results from the Ontario (Canada) ovarian cancer kin-cohort study." Clinical Oncological Society of Australia annual scientific meeting, Brisbane, Australia (Sponsored by the Queensland Cancer Fund).

6/05 Seminar: "Why Pancreas Cancer is Less Frequent in China than the US, in spite of the Generally Higher Chinese Prevalence of Risk Factors: Insights on the Etiology of Pancreas Cancer." Tumor Registrars Association of Connecticut Quarterly Meeting, Yale-New Haven Hospital, New Haven, CT.

5/05 Seminar: "Why Pancreas Cancer is Less Frequent in China than the US, in spite of the Higher Prevalence of Risk Factors There: Insights on the Etiology of Pancreas Cancer." Sylvester Comprehensive Cancer Center, University of Miami, Miami, FL.

5/02 Symposium: "Genetic Epidemiology of Ovarian Cancer." Ovarian Cancer and High-Risk Women: Implications of Prevention, Screening and Early Detection. University of Pittsburgh, Pittsburgh, PA.

12/01 Seminar: "Prevalence and Penetrance of Germline BRCA1 and BRCA2 Mutations in Unselected Ovarian Cancer." Kaplan Cancer Center, NYU School of Medicine, New York, NY.

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10/01 Research Seminar: "Prevalence and Penetrance of Germline BRCA1 and BRCA2Mutations in Unselected Ovarian Cancer." Memorial Sloan Kettering Cancer Center, New York, NY.

6/01 Combined Monthly Research Seminar: "Prevalence and Penetrance of Germline BRCA1 and BRCA2 Mutations in Unselected Ovarian Cancer." Programs in Ovarian Cancer, Cancer Genetics and Cancer Prevention, Yale Cancer Center, New Haven, CT.

10/00 Departmental Seminar: "Etiology of Epithelial Ovarian Cancer." Department of Public Health Sciences, Fox Chase Cancer Center, Philadelphia, PA.

9/98 "Etiologic Mechanisms in Epithelial Ovarian Cancer," Third International Symposium on Hormonal Carcinogenesis, Seattle, WA.

5/98 Departmental Grand Rounds: "BRCA1 and BRCA2 Mutations in Unselected Ovarian Cancer," Department of Gynecologic Oncology, Yale University School of Medicine, New Haven, CT.

9/97 Departmental Seminar: "Etiologic Mechanisms in Epithelial Ovarian Cancer." Division of Epidemiology, Columbia University School of Public Health, New York, NY.

9/97 "Use of aspirin and other non-steroidal anti-inflammatory drugs and risk of esophageal and gastric cancer." American College of Epidemiology Annual Meetings, Cambridge, MA.

3/97 "Risk Factors for Familial and Hereditary Ovarian Cancer." American Cancer Society Science Writers Seminar, Reston, VA.

2/97 Departmental Grand Rounds: "Etiologic and Histologic Considerations in the Occurrence of Ovarian Cancer." Department of Pathology, Yale School of Medicine, New Haven, CT.

1/97 Departmental Seminar: "Ovarian Cancer Pathophysiology: Etiologic and Methodologic Issues." Department of Epidemiology, University of North Carolina School of Public Health, Chapel Hill, NC.

6/96 "Risk factors for BRCA1-associated ovarian cancer." NCI Extramural Genetic Epidemiology PIs Second Biennial Meetings, Frederick, MD.

6/96 "Estrogen replacement therapy and the risk of epithelial ovarian cancer." Society for Epidemiologic Research Annual Meetings, Boston, MA.

6/95 "Pelvic inflammatory disease and the risk of epithelial ovarian cancer." Society for Epidemiologic Research Annual Meetings, Snowbird, UT.

6/94 "Dietary fat intake and the risk of epithelial ovarian cancer." Society for Epidemiologic Research Annual Meetings, Miami, FL.

6/93 "A cohort study of menopausal hormone usage and breast cancer in Saskatchewan." Society for Epidemiologic Research Annual Meetings, Keystone, CO.

2/93 "A cohort study of menopausal hormone usage and breast cancer in the province of Saskatchewan, Canada." International Epidemiology Association Regional European Meeting, Jerusalem.

9/92 "A record-linkage cohort study of menopausal hormone usage and breast cancer in Saskatchewan." American College of Epidemiology Annual Meetings, Bethesda, MD.

9/92 "Record-linkage cohort study of menopausal hormone usage and breast cancer."

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Yale/Dana Farber Conference on Cancer Prevention and Control, Department of Epidemiology and Public Health, Yale University, New Haven, CT.

6/92 "Are female smokers at higher risk for lung cancer than male smokers? A case-control analysis by histologic type." Society for Epidemiologic Research Annual Meetings, Minneapolis, MN.

12/91 Departmental Seminar: "Some interesting results on lung cancer in women." Department of Epidemiology and Public Health, Yale University, New Haven, CT.

11/89 Departmental Seminar: "Occupational and dietary associations with bladder-cancer incidence." Department of Epidemiology and Public Health, Yale University, New Haven, CT.

8/89 "A demonstration of the GLIMP computer program for epidemiologic analysis." Canadian Epidemiology Research Conference Meetings, Ottawa.

4/89 "Nonlinear dose-response models with standard logistic regression." Upstate New York and Southern Ontario Epidemiology Group Meetings, Toronto.

6/88 "A unified framework for meta-analysis by maximum likelihood." Society for Epidemiologic Research Annual Meetings, Vancouver.

4/88 Departmental Seminar: "Occupational and dietary factors in the study of cancer of the bladder." Division of Epidemiology and Biostatistics, Graduate School of Public Health, San Diego State University, San Diego, CA.

3/88 Seminar: "Diet and occupation in the causation of bladder cancer." School of Public Health, New York State Department of Health, SUNY, Albany, NY.

12/87 Departmental Seminar: "Dietary and occupation factors in a case-control study of bladder cancer." Department of Epidemiology, Harvard School of Public Health, Boston, MA.

12/87 Departmental Seminar: "Risk factors for spontaneous abortion and its recurrence, and habitual abortion." Department of Medical Genetics, Hospital for Sick Children, Toronto.

11/87 Departmental Seminar: "Occupational and dietary factors in the causation of bladder cancer." Department of Social and Preventive Medicine, SUNY School of Medicine, Buffalo, NY.

11/87 Departmental Seminar: "Dietary and occupational factors in the study of bladder cancer." Department of Epidemiology and Biostatistics, University of Western Ontario, London.

9/87 Departmental Seminar: "Dietary and occupational factors in a case-control study of bladder cancer." Department of Epidemiology and Community Medicine, University of Ottawa.

11/86 Departmental Seminar: "Application of linear structural hypotheses in observational epidemiologic studies." Department of Environmental and Occupational Medicine, Mount Sinai School of Medicine, New York, NY.

9/86 Departmental Seminar: "Application of linear structural equations in observational epidemiologic studies." Department of Epidemiology and Public Health, Yale University, New Haven, CT.

6/86 "Measuring tumor induction period in case-control studies of chronic exposures."

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Society for Epidemiologic Research Annual Meetings, Pittsburgh, PA. 8/84 "Nitrate and ascorbate in a study of gastric cancer." International Epidemiology

Association Meetings, Vancouver. 5/84 "An improved method for obtaining confidence intervals of the odds ratio in logistic

regression." Epidemiologic Methods Workshop, Upstate New York and SouthernOntario Epidemiology Group Meetings, Toronto.

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Curriculum Vitae of Thomas Jefferson, MD MRCGP FFPHM(Exhibit A to Jefferson Declaration)

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http://ebm.bmj.com/cgi/content/full/bmjebm-2019-111321.

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Curriculum Vitae of Peter McCullough, MD, MPH(Exhibit A to McCullough Declaration)

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Tuesday, October 6, 2021 CURRICULUM VITAE

PETER A. McCULLOUGH, MD, MPH, FACC, FCCP, FAHA, FNKF, FNLA, FCRSA

Business HeartPlace 3409 Worth Street, #500 Dallas TX 75246 Desk: 214-841-2000 Cell: 248-444-6905 e-mail: [email protected]

Home 5231 Richard Avenue Dallas, TX 75206

Birth date December 29, 1962 Birthplace Buffalo, NY, USA EDUCATION

1) Certificate of Graduate Liberal Arts Studies: Southern Methodist University, December 17, 2016, principal faculty Dr. Anthony Picchioni, PhD, Adjunct Professor in Human Development, P.O. Box 750181, Dallas, TX 75275, 214-768-3417, www.smu.edu

Graduated with Honor

2) Master of Public Health: University of Michigan School of Public Health, August 19, 1994, Dean Noreen M. Clark, PhD, 109 Observatory Street, Ann Arbor, MI 48109-2029, phone 734-764-5454, www.sph.umich.edu

Major: General Epidemiology

3) Doctor of Medicine: University of Texas Southwestern Medical School, June 4, 1988, Dean Bryan M. Williams, MD, 5323 Harry Hines Boulevard, Dallas, TX 75235-9070, 214-648-3111, http://www.utsouthwestern.edu/education/medical-school/

Clinical year rank of 1 in 199, overall rank in class of 12 in 199 Alpha Omega Alpha Texas Gamma Chapter, installed March 17, 1988

4) Bachelor of Science: Baylor University, May 18, 1984, Chancellor Abner McCall, PhD, Office

of the Registrar, Waco, TX 76798-7056, 254-710-1181, http://www.baylor.edu/ Double-major: Biology and Psychology Graduated with Honor, degree rank of 29 in 131, university rank of 127 in 1,152

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Alpha Lambda Delta Freshman Honorary, installed March 19, 1981 POSTGRADUATE TRAINING

1) Cardiovascular Diseases Fellowship: William Beaumont Hospital (WBH) (presently Oakland University William Beaumont School of Medicine), Division of Cardiology, 3601 W. Thirteen Mile Rd, Royal Oak, MI 48073, 248-551-4198, 7-1-94 to 6-30-97, Chief Cardiovascular Fellow for 1996-97, William W. O’Neill, MD, Program Director and Division Chief

2) Internal Medicine Residency: University of Washington School of Medicine, Department of

Internal Medicine, 1959 NE Pacific, Seattle, WA 98195, (206) 543-3239, 3-year traditional track, 7-1-88 to 6-30-91, James F. Wallace, MD, Program Director, Paul G. Ramsey, MD, Chairman of Medicine

PROFESSIONAL EXPERIENCE

HeartPlace , 3409 Worth Street, Suite 500, Dallas TX 75246, March 1, 2021. Positions Held: 1) Attending Physician Baylor Scott and White Health, Baylor Health Care System, Baylor University Medical Center (BUMC), Baylor Heart and Vascular Institute, Baylor Jack and Jane Hamilton Heart and Vascular Hospital, Dallas TX, Texas A & M University College of Medicine, Department of Medicine, Division of Cardiology, Baylor Heart and Vascular Institute, 621 N. Hall St., #H030, Dallas, TX 75226, February 3, 2014 to February 25, 2021. Cardiovascular Governance Council, Kevin Wheelan, MD, Cardiology Division Chief and Chief Medical Officer, Heart Institute Office (214) 820-7500 Positions Previously Held:

1) Professor in the Principal Faculty, Non-Tenure Track in the Department of Internal Medicine, Texas A & M University Health Sciences Center (2016-2021) 2) Chief of Cardiovascular Research (2014-2021) 3) Program Director, BUMC Cardiovascular Diseases Fellowship Program (2014-2021)

4) Vice Chief, BUMC Internal Medicine (2016-2021) St. John Providence Health System, Providence Park Heart Institute, Department of Medicine, Cardiology Section, 47601 Grand River Avenue, Suite B-125, Novi, MI 48374, September 1, 2010 to July 19, 2013. Department of Medicine Chair, Anibal Drelichman, MD: 248-849-3152, Cardiology Section Chief: Shukri David, MD, 248-465-5955 Positions Previously Held:

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1) Chief Academic and Scientific Officer (Academic Dean Equivalent), St. John Providence Health System, (2010 to 2013) 2) Medical Director, Clinical Lipidology, Department of Medicine, Cardiology Section (2010 to 2013)

William Beaumont Hospital, Department of Internal Medicine, Divisions of Nutrition and Preventive Medicine, Department of Cardiology, 3601 West Thirteen Mile Road, Royal Oak, MI 48073, October 1, 2002 to 2010. Department of Medicine Chair: Michael A. Maddens, M.D., 248-551-0622, Department of Cardiology Chair: David E. Haines, M.D., 248-858-0404 Oakland University William Beaumont School of Medicine, 472 O'Dowd Hall 2200 N. Squirrel, Rochester, MI 48309, Robert Folberg, MD, Medical School Dean, Kenneth Hightower, PhD, Dean of Allied Health Sciences, 248-370-3562. Clinical Professor of Health Sciences and Medicine (2007 to 2010) Positions Previously Held:

1) Consultant Cardiologist and Chief, Division of Nutrition and Preventive Medicine (2002 to 2010), Department of Internal Medicine

2) Medical Director, Preventive Cardiology (2002 to 2010) 3) Medical Director, Lipid Apheresis Program (2007 to 2010) 4) Medical Director, Weight Control Center (2002-2005)

University of Missouri-Kansas City (UMKC) School of Medicine, Truman Medical Center,

Department of Medicine, Cardiology Section, 2301 Holmes St., Kansas City, MO 64108. August 18, 2000-September 30, 2002. Department of Medicine Chair: George R. Reisz, M.D, 816-556-3450

Positions Previously Held:

1) Associate Professor of Medicine (Tenure Track) and Cardiology Section Chief (2000-2002)

Henry Ford Health System (HFHS), Henry Ford Heart and Vascular Institute, 2799 W. Grand

Blvd., K-14, Detroit, MI 48202, July 1, 1997 to August 16, 2000. Cardiovascular Division Head: W. Douglas Weaver, M.D, 800-653-6568


1) Assistant Professor of Medicine (Tenure Track), Case Western Reserve University School of Medicine, and HFHVI Senior Staff Cardiologist

Medical Director, Preventive Cardiology, 1999-2000 2) Program Director, Cardiovascular Diseases Fellowship Training Program, 1999-2000 3) Director of Cardiovascular Informatics Section, 1997-2000

4) Associate Director of the Center for Clinical Effectiveness, 1997-99

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5) Associate Director of the Cardiovascular Diseases Fellowship Program, 1998-99

Emergency Physicians Medical Group, PC, 2000 Green Road, Suite 300, Ann Arbor, MI 48105,

800-466-3764. Emergency medicine attending at Mission Health McPherson Hospital, Howell, 1991-1997; Oakwood Beyer Hospital Center, Ypsilanti 1991-1997, and Mercy Hospital, Grayling 1991-1992


1) Associate Member 2) Washtenaw County Human Services Deputy Medical Examiner, 1995-1996 Mercy Internal Medicine Associates, 308 Michigan Avenue, Grayling, MI 49738, Mercy

Hospital-Grayling, 1100 Michigan Avenue, Grayling, MI 49738, 517-348-5461. Internal medicine attending at Mercy Hospital, Grayling, MI, 1991-1992


1) Coronary Care Unit Director 2) Physician Director of Cardiopulmonary Services

SPECIAL TRAINING

1) The Healthcare Forum Cardiovascular Health Fellowship, 1998-99 2) American Heart Association (AHA), 23rd 10-Day U.S. Seminar on the Epidemiology and

Prevention of Cardiovascular Disease, July-August, 1997 3) University of Michigan Summer Session in Epidemiology, 1997-99 4) Stanford University Course on Medical Informatics, Palo Alto, CA, June, 1997 5) Current Practice of Vascular Ultrasound 3-Day Course, Chicago, IL, April, 1997 6) Advanced Pacemaker Concepts Course, CPI, Inc., Lansing, MI, 1995 7) Pacesetter Comprehensive Pacemaker 4-Day Course, Santa Fe, NM, 1997 8) Medtronic Bakken Education Tutorial and Medtronic Applied Physiological Research

Laboratory Lead Implantation Training and Biventricular Implantation Training (2 sessions), Minneapolis, MN, 2001-2002

9) 2004 ASCeXAM Review Course, American Society of Echocardiography, San Francisco, CA, April 22-24, 2004

10) National Lipid Association Masters Course in Clinical Lipidology, Hilton Head, SC, August 21-23, 2008

CERTIFICATION AND LICENSURE

1) Licensed in the State of Washington 1988-1997 (#MD00027562), Michigan expires January 31, 2022 (#4301058147), and New York 1992 to present (#189283 inactive status), Missouri 2000-2002 (#2000165365 inactive status) and Texas expires May 31, 2022 (#P9222)

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2) FLEX passed April 4, 1990, State of Washington, Department of Health, Board of Medical Examiners

3) Diplomate, American Board of Internal Medicine, Candidate #136084, September, 25, 1991, recertified May 1, 2001, recertified June 10, 2011, recertified April 6, 2021, valid through 2031, 510 Walnut Street, Suite 1700, Philadelphia, PA 19106-3699

4) Diplomate, American Board of Internal Medicine, Cardiovascular Diseases Subspecialty, Candidate #136084, November, 1997, valid through 2007, recertified October 1, 2007, valid through 2017, recertified September 28, 2017, valid through 2027, 510 Walnut Street, Suite 1700, Philadelphia, PA 19106-3699

5) Diplomate, American Board of Clinical Lipidology, September 27, 2008, 6816 Southpoint Parkway, Suite 1000, Jacksonville, FL 32216. Fellow, National Lipid Association

6) National Board of Echocardiography (NBE), Examination of Special Competence in Adult Echocardiography, 2004-2014 expired

7) Diplomate, American Board of Forensic Examiners, July 16, 1996, no expiration date RECOGNITION

Teaching:

1. Henry Ford Hospital, 1999 Chief Medical Resident's Best Teacher Award

Research: 1. Chest Foundation Young Investigator Award 2001, Philadelphia, PA, November 7, 2001,

President’s International Awards Ceremony

2. National Kidney Foundation (NKF) of Michigan, Innovations in Health Care Award Finalist 2008, East Lansing, MI, April 17, 2008

3. American College of Cardiology (ACC) Simon Dack Award for Scholarly Excellence by the

Journal of the American College of Cardiology, March 5, 2009

4. 11th International Vicenza Award in Critical Care Nephrology, International Renal Research Institute, Vicenza, Italy, June 11, 2013

Postgraduate:

1. Founding Fellow, Cardiorenal Society of America, March 2016 2. Fellow, National Lipid Association, January, 2013 3. Fellow, National Kidney Foundation, January, 2012 4. Fellow, American College of Chest Physicians, February, 2001 5. Fellow, American College of Physicians, January, 2001 to September, 2021 6. Fellow, American College of Cardiology, February, 1999

AFFILIATIONS

1) Alpha Omega Alpha, National Honor Medical Society, 1988 to present

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2) American College of Emergency Physicians, Member, 1992-1994 3) American College of Forensic Examiners, Member 1996 to present 4) AHA, Council on Epidemiology and Prevention, 1995 to present 5) AHA, Grassroots Network, 1998-2000. 6) Central Society for Clinical Research, Member, 1999-2000 7) Council on Geriatric Cardiology, Member 1996-1997 8) Michigan Chapter of the ACC, Chair, Annual Cardiology Board Review, 1999-2000 9) Michigan State Medical Society, Member, 1997-2000, 2004 to 2009 10) The American Medical Informatics Association, 1997-2000 11) The Health Forum, Charter Cardiovascular Health Charter Alumni Representative, 1998 to

2002 12) Cardiorenal Society of America, Founding Executive Board Member, 2013 to present, Vice

President 2014-2016, President 2016 to present 13) Dallas County Medical Society, 2014 to present 14) Texas Medical Association, 2014 to present 15) Baylor Alumni Association, 2015 to present 16) New York Academy of Sciences, 2016 to present 17) Truth for Health Foundation, Founding Executive Board Member, Chief Medical Advisor,

2021 to present

EDITORIAL RESPONSIBILITIES

1) Advances in Chronic Kidney Disease, Editorial Board Member, 2003-present. [referenced through Elsevier Bibliographic Database, EMBASE/Excerpta Medica, MEDLINE]

2) American Journal of Cardiology, Associate Editor, 2014 to present 3) American Journal of Kidney Disease, [referenced through Elsevier Bibliographic Database,

EMBASE/Excerpta Medica, MEDLINE] Associate Editor, 2006 to 2019, Guest Editor, 2011, 2012

4) Arquivos Brasileiros de Cardiologia, International Editorial Board, 2006 to present 5) Biocritique, Editorial Board, 2001 to 2013, www.biocritique.com 6) Blood Purification, Editorial Board 2018 to present 7) Cardiovascular Clinician, Editorial Board, 2011 to 2013, internet site,

CARDIOVASCULARClinician.com™ 8) Cardiovascular Diagnosis and Therapy (CDT), Editorial Board (Print ISSN: 2223-3652; Online

ISSN: 2223-3660, 2012 to present 9) Cardiovascular Innovations and Applications (CVIA), Editorial Board 2015 to present 10) Cardiorenal Medicine, Associate Editor, 2016-2017, Editor-in-Chief 2018 to 2021 11) Circulation, Editorial Board, 2016 to present 12) Circulation Heart Failure, Editorial Board, 2008 to present, Associate Editor, 2008 to 2016,

Guest Editor 2010, 2011, 2012 13) Clinical Exercise Physiology, Clinical Consultant to the Editorial Board, 1998-2002. 14) Cochrane Renal Group Module, 2008, Editorial Contributor, Centre for Kidney Research, The

Children’s Hospital at Westmead, Westmead NSW, Australia

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15) Expert Review of Cardiovascular Therapy, Editorial Advisory Panel, 2002 to present, www.future-drugs.com 16) Journal of the American College of Cardiology, Editorial Consultant, 2003-present. “Elite Reviewer” Recognition, 2004, 2005, 2006, 2007, 2008, 2011, 2014, 2016 (DeMaria AN. The elite reviewer. J Am Coll Cardiol 2003;41(1):157-8.) 17) Journal of Geriatric Cardiology, Editorial Board Member, 2003-present. The Institute of

Geriatric Cardiology, Chinese PLA Hospital, Beijing. [Joint China-U.S.A. publication] 18) Journal of Biorepository Science for Applied Medicine, Honorary Editorial Board, 2012 to

2018 19) Journal of Clinical & Experimental Cardiology, OMICS Publishing Group, Open Access,

CrossRef, PubMed, DOAJ, Index Copernicus, Scientific Commons, EBSCO, 2010 to 2017 20) Journal of Diabetes & Metabolism, OMICS Publishing Group, Open Access, 2010 to 2017 21) Journal of Interventional Cardiology, “News and Views”, Section Editor, 2000-2003.

Editorial Board Member, 2003 to present 22) Journal of Nephrology and Therapeutics, Editorial Board, OMICS Publishing Group, Editorial

Board, 2010 to 2017 23) Reviews in Cardiovascular Medicine, MedReviews, LLC, www.medreviews.com “Cardiorenal

Function,” Section Editor, 2001-2002, Associate Editor, 2003-2009, Co-Editor, 2009 to present

24) The American College of Cardiology Foundation ACCEL Audio Journal, Editorial Board 2008 to present

25) The Open Atherosclerosis & Thrombosis Journal, [referenced through Bentham Open, PubMed, Google and Google Scholar] Editorial Board, 2008 to 2012

26) The Open Heart Failure Journal, [referenced through Bentham Open, PubMed, Google and Google Scholar] Editorial Board, 2008 to 2010

27) Therapy, [referenced through Elsevier Bibliographic Database, EMBASE/Excerpta Medica, MEDLINE], Editorial Board, 2008 to 2010

Manuscript Reviewer

1) Advances in Chronic Kidney Disease, 2004 to present (18) 2) Advances in Medical Sciences, 2012 to present (2) 3) Advances in Therapy, 2008 to present (1). 4) American Family Physician, 2004 to present (2) 5) American Journal of Cardiovascular Drugs, 2002 to present. (2) 6) American Heart Journal (AHJ), 1998 to present (22) 7) American Journal of Cardiology (AJC), 1999 to present (60) 8) American Journal of Human Biology, 2014 to present (1) 9) American Journal of Hypertension, 2011 to present (1) 10) American Journal of Kidney Diseases (AJKD), 2002 to present (30) 11) American Journal of Medicine (AJM), 1997 to present (7) 12) American Journal of the Medical Sciences (AJMS), 2006 to present (3) 13) American Journal of Nephrology, 2004 to present (24) 14) American Journal of Physiology: Renal Physiology, 2006 to present (2)

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15) American Journal of Transplantation, 2004 to present (1) 16) Annals of Epidemiology, 2004 to present (1) 17) Annals of Internal Medicine, 2008 to present (3) 18) Annals of Noninvasive Electrocardiology, 2009 to present (1) 19) Antimicrobial Agents and Chemotherapy, 2020 to present (1) 20) Archives of Internal Medicine, 2004 to present (2) 21) Archives of Pathology and Laboratory Medicine, 2007 to present (1) 22) Arteriosclerosis, Thrombosis, and Vascular Biology, 2010 to present (2) 23) Autonomic Neuroscience: Basic and Clinical, 2007 to present (1) 24) BUMC Proceedings, 2012 to present (3) 25) Biochemia Medica, 2012 to present (1) 26) Biomed Central (BMC) Medical Imaging, 2010 to present (1) 27) Blood Purification, 2010 to present (2) 28) BMC Medicine, 2007 to present (1) 29) BMC Nephrology, 2011 to present (1) 30) BMJ Clinical Evidence, 2008 to present (1) 31) British Medical Journal (BMJ), 2009 to present (1) 32) Canadian Medical Association Journal (CMAJ), 2006 to present (3) 33) Cardiac Failure Review, 2015 to present (1) 34) Cardiology, 2007 to present (1) 35) Cardiorenal Medicine; 2013 to present (10) 36) Cardiovascular Innovations and Applications, 2016 to present (1) 37) Cardiovascular Therapeutics, 2010 to present (1) 38) Catheterization and Cardiovascular Interventions, 2000 to present (6) 39) Chest, 2000 to present (6) 40) Circulation, 1998 to present (100) 41) Circulation Cardiovascular Interventions, 2012 to present (1) 42) Circulation Cardiovascular Quality and Outcomes, 2010 to present (1) 43) Circulation Heart Failure, 2009 to present (4) 44) Circulation Imaging, 2012 to present (1) 45) Cleveland Clinic Journal of Medicine, 2008 to present (1) 46) Clinica Chimica Acta, 2013 (1) 47) Clinical Cardiology, 2001 (3) 48) Clinical Chemistry and Laboratory Medicine, 2010 to present (2) 49) Clinical Exercise Physiology, 2000-2002 (4) 50) Clinical Journal of the American Society of Nephrology 2008 to present (3) 51) Clinical Kidney Journal, 2012 to present (1) 52) Clinical Medicine and Research, 2008 to present (1) 53) Clinical Nephrology, 2008 to present (2) 54) Clinical Physiology and Functional Imaging, 2010 to present (1) 55) Clinical Researcher, 2002 to present (1) 56) Clinics, 2010 to present (1) 57) Cochrane Collaboration,2009 to present (2) 58) Congestive Heart Failure, 2005 to present (4)

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59) Coronary Artery Disease, 2005 to present (1) 60) Critical Care Medicine, 2008 to present (2) 61) Current Medical Research and Opinion, 2005 to present (1) 62) Diabetes Care, 2011 to present (2) 63) Diabetes and Vascular Disease Research, 2011 to present (1) 64) Diabetes, Obesity, and Metabolism, 2019 to present (1) 65) Diabetic Medicine, 2008 to present (1) 66) Drug Benefit Trends, 1999 (1) 67) Drugs, 2000 (2) 68) European Heart Journal, 1995 (12) 69) European Journal of Cardiovascular Prevention and Rehabilitation, 2006 (1) 70) European Journal of Heart Failure, 2012 (4) 71) Expert Opinion on Pharmacotherapy, 2003 to present (3) 72) Expert Opinion Therapeutic Patents, 2004 to present (1) 73) Expert Review of Cardiovascular Therapy, 2008 to present (2) 74) Global Heart, 2012 (1) 75) Heart, 2004 (2) 76) Heart and Vessels, 2007 (2) 77) Hemodialysis International 2013 (2) 78) Internal Medicine Journal (Australasia), 2009 to present (1)

79) International Journal of Infectious Diseases 2020 to present (2) 80) International Journal of Nephrology, 2010 to present (2) 81) Journal of Biomarkers, 2013 (1) 82) Journal of Geriatric Cardiology, 2017 (1) 83) International Journal of Infectious Diseases, 2021 to present (3) 84) Journal of Internal Medicine, 2009 to present (1) 85) Journal of Interventional Cardiology (JIC), 1996 to present (9) 86) Journal of the American College of Cardiology (JACC), 1998 to present (228) 87) Journal of the American College of Cardiology: Heart Failure (JACC Heart Fail), 2014 to

present (12) 88) Journal of the American College of Cardiology: Imaging (JACC Imag), 2014 to present (6) 89) Journal of the American College of Cardiology: Interventions (JACC Interv), 2010 to present

(10) 90) Journal of the American Medical Association (JAMA), 2002 to present (60) 91) Journal of the American Medical Association Cardiology (JAMA Cardiology), 2016 to present

(20) 92) Journal of the American Society of Echocardiography (JASE), 2009 to present (1) 93) Journal of the American Society of Nephrology (JASN) 2005 to present (14) 94) Journal of Cardiac Failure, 2003 to present (10) 95) Journal of Clinical Outcomes Management, 2011 to present (1) 96) Journal of Critical Care, 2011, to present (1) 97) Journal of General Internal Medicine, 2008 to present (1) 98) Journal of Human Hypertension, 2010 to present (1)

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99) Journal of Inherited Metabolic Disease, 2014 to present (2) 100) Journal of Lipid Research, 2010 to present (1) 101) Journal of Managed Care, 2004 to present (1) 102) Journal of Physiology and Pathophysiology, 2009 to present (1) 103) Kidney and High Blood Pressure Research, 2008 to present (1) 104) Kidney International, 2004 to present (8) 105) Medical Science Monitor, 2008 to present (1) 106) Medicine & Science in Sports and Exercise, 2005 to present (3) 107) Nature Clinical Practice Cardiovascular Medicine, 2004 to present (4) 108) Nature Clinical Practice Nephrology, 2008 to present (1) 109) Nature Reviews Nephrology, 2009 to present (3) 110) Nephron, 2005 to present (1) 111) Nephrology, 2009 to present (1) 112) Nephrology, Dialysis, and Transplantation, 2005 to present (7) 113) New England Journal of Medicine, 2006 to present (8) 114) Pharmacological Research (Italy), 1999 (1) 115) Pharmaceutical Sciences, 2011 (1) 116) PLoS Medicine, 2005 (1) 117) PLOS ONE, 2013 (1) 118) Prehospital Emergency Care, 2015 (1) 119) Preventive Medicine, 2008 (1) 120) Rejuvenation Research, 2007 (1) 121) Renal Failure, 2011 (2) 122) The Lancet, 1999 to present (11) 123) The Lancet Diabetes, 2013 to present (5) 124) The Lancet Global Health, 2015 to present (2)

Major Meeting Abstract Grader

1) ACC Scientific Sessions 2001 to present (10) 2) ACC I2 Summit, 2006 to present (2) 3) American Diabetes Association, 2008 to present (13) 4) AHA Scientific Sessions, 1997 to present (8) 5) American Medical Informatics Association, Annual Symposium, 1998-2001 (3) 6) International Academy of Cardiology World Congress on Heart Disease, Academy of

Cardiology Annual Scientific Sessions—Mechanisms and Management, 2002-present (3) 7) Transcatheter Therapeutics (TCT), 2004 (1) Grant Reviewer 1. National Medical Research Council, Singapore, 2003-2004 2. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney

Diseases, Special Emphasis Panel/Initial Review Group 2006/01 ZDK1 GRB-9, 2005

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3. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Special Emphasis Review Group, 1 R01 DK070033-01A2, 2006

4. National Institutes of Health, National Heart Lung and Blood Institute, Study Section, ZHL1 CSR-H (M1), March 6-7, 2006, Heart Failure Network

5. Diabetes UK, The British Diabetic Association, Macleod House, 10 Parkway, London NW1 7AA. December 24, 2008

6. National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases, Special Review Panel, Chronic Renal Insufficiency Cohort Study (CRIC) and A Prospective Cohort Study of Kidney Disease in Children (CKiD) Study, February 23-25, 2012, March 6, 2013

7. National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases, Special Review Panel, ZDK1 GRB-7 (O3)S in response to PAR-DK-09-247: Ancillary Studies to Major Ongoing Clinical Research Studies to Advance Areas of Scientific Interest within the Mission of the NIDDK (R01), July 11, 2012

8. Alberta Innovates Health Solutions Collaborative Research & Innovation Opportunities (CRIO) Grant Review, September, 2012

9. Health Research Board of Ireland, Health Research Awards, 2013 10. National Institutes of Health National Institute of Diabetes and Digestive and Kidney

Diseases 2017/01 ZRG1 DKUS-R (55) Study Section 2016

Guidelines Reviewer

1. Kidney Disease Improving Global Outcome (KDIGO) Guidelines Review

a. Prevention, Diagnosis, Evaluation and Treatment of Hepatitis C in Chronic Kidney Disease, Published April, 2008

b. Diagnosis, Evaluation, Prevention and Treatment of Chronic Kidney Disease related Mineral and Bone Disorders (CKD-MBD), Published August, 2009

c. Acute Kidney Injury (AKI), published March, 2012

CLINICAL TRIAL AND STUDY RESPONSIBILITIES

Overall Study Responsibilities: Steering and Executive Committees

1) Study Principal Investigator, Medicine vs Angiography for Thrombolytic Exclusion Patients

(M.A.T.E.), 1994-1997, (multicenter, U.S., randomized controlled trial [RCT]). Status: closed.

2) Study Principal Investigator, The Resource Utilization Among Congestive Heart Failure Study

(R.E.A.C.H.), 1998-2000, (single-center, prospective cohort study). Status: closed.

3) Study Principal Investigator, The Asthma, Beta-Agonists, and Congestive Heart Failure Study, (A.B.C.H.F.), 1998-1999, (single-center, case-control study). Status: closed.

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4) Study Co-Principal Investigator, The Prevention of Radiocontrast Induced Nephropathy

Clinical Evaluation (P.R.I.N.C.E.) Study, 1995-1998, (single-center, RCT). Status: closed.

5) Study Co-Principal Investigator, BNP Multinational Study, Principal Investigator, Alan Maisel, MD, Biosite Diagnostics, Inc., 2000-2006, (multicenter, international, prospective cohort study). Status: closed.

6) Study Co-Investigator, Prophylactic Oral Amiodarone Compared to Placebo for Prevention

of Atrial Fibrillation Following Coronary Artery Bypass Graft Surgery (P.A.P.A.C.A.B.G.), 1996-1998, (single-center, RCT). Status: closed.

7) Study Co-Investigator, Rapid Early Bedside Markers of Myocardial Injury, 1998-1999, HFHS

and Biosite Diagnostics, Inc. (prospective cohort study). Status: closed.

8) Member, Steering Committee, Clinical Study Protocol No. 2000-025: A Phase IIIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Safety, Efficacy, and Tolerability of Fenoldopam Mesylate in Subjects Undergoing Interventional Cardiology Procedures (CONTRAST), William W. O’Neill, MD and Gregg Stone, MD, Co-Principal Investigators, Abbott Laboratories, Inc., 2000-2003 (multicenter, US, RCT). Status: closed.

9) Chair, National Steering Committee, Kidney Early Evaluation Program (KEEP) NKF, Member

2000-2005, Co-Chair 2005-2010, Chair 2010-present (multicenter, U.S., prospective cohort study). Annual budget ~$1,325,198 (2009), ~$1,233,832 (2010), ~$1,614,953.00 (2011), ~$989,500 (2012), ~$1,217,000 (2013). Status: inactive.

10) Member, Steering Committee, Protocol No. 704.351 Evaluation of Synergy between

Natrecor and Furosemide on Renal and Neurohormone Responses in Chronic Heart Failure: A Phase IV Study, Scios Inc., 2003-2005 (multicenter, U.S., randomized cross-over trial). Status: closed.

11) Member, Steering Committee, Protocol No. CCIB002FUS12. A Multicenter, Double-blind,

Randomized, Parallel Group Study to Evaluate the Effects of Lotrel and Lotensin HCT on Microalbuminuria in Mild to Moderate Hypertensive Subjects with Type 2 Diabetes Mellitus, Novartis Pharmaceuticals, Inc., 2003-2006. Status: closed.

12) Rotating Executive Committee Principal Investigator Member, NIH HF-ACTION Trial (Exercise

Training Program to Improve Clinical Outcomes in Individuals With Congestive Heart Failure), HL63747 01A2, 2006-2009. Principal Investigator, David Whellan, MD, status: closed.

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13) Overall Study Principal Investigator, Neutrophil Gelatinase-Associated Lipocalin: A Novel Blood Marker for Risk of Developing Contrast Induced Nephropathy (ENCINO), multicenter, prospective, blinded cohort study, 2006-2009, status: closed.

14) Member, Steering Committee, VA NEPHRON-D: Diabetes iN Nephropathy Study, 2008 to

2013, trial stopped early for safety cardiovascular and acute kidney safety concerns in angiotensin converting enzyme inhibitor plus losartan arm, status: closed.

15) Member, External Expert Panel, National Institutes of Health, National Institute of Digestive

and Diabetes and Kidney Diseases, Chronic Renal Insufficiency Cohort Study, status open, 2010 to present.

16) Member, Optimal Medical Management Subcommittee, National Institutes of Health,

National Heart Lung and Blood Institute, International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA), status: open, 2011 to present.

17) Member, Steering Committee, National Institutes of Health, National Heart Lung and Blood

Institute, International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) in patients with Chronic Kidney Disease (ISCHEMIA-CKD), status: open, 2012 to present.

18) Member, Steering Committee, Thrasos Innovation, Inc, A Phase II Multi-Center, Parallel-

Group, Randomized, Double Blind, Proof-of-Concept, Adaptive Study Investigating the Safety and Efficacy of THR-184 Administered via Intravenous Infusion in Patients at Increased Risk of Developing Cardiac Surgery Associated-Acute Kidney Injury (CSA-AKI), status: closed, 2012 to 2015.

19) Overall Principal Investigator, AbbVie, Inc, Clinical Study Protocol M13-796, A Phase 2b,

Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Trial of Multiple Dosing Regimens of ABT-719 for the Prevention of Acute Kidney Injury in Subjects Undergoing High Risk Cardiac Surgery, status: closed, 2013 to 2014.

20) Overall Principal Investigator, Bioporto, Inc, The NGAL Test™ As An Aid in the risk

assessment for AKI stage II and III in an Intensive Care Population, status: open 2017 to present.

21) Member, Global Expert Panel, Novo Nordisk, Inc, A Research Study to See How Semaglutide

Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease (FLOW), status: open.

Overall Study Responsibilities: Endpoint Committees

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1) Member, Critical Endpoints Committee, Treat Angina with Aggrastat and Determine Cost of Therapy with an Invasive or Conservative Strategy, TACTICS-TIMI 18 (Protocol 019-00), 1998-2000, (multicenter, international, RCT). Status: closed

2) Member, Study Endpoints Committee, A Phase II, Escalation Trial of Vasoflux in Patients

Undergoing Thrombolysis with Streptokinase for Acute Myocardial Infarction, Protocol CLN-P-V18-07001, Parexel International Corporation,1998, (multicenter, international, RCT). Status: closed

3) Member, Safety Endpoint Evaluation Committee, A Phase III, Single-Blind Controlled Study

to Evaluate the Clinical Effects of a Hemoglobin-based Oxygen Carrier (HBOC-210) Given as a Transfusion Alternative in Patients Undergoing Orthopedic Surgery. (Protocol HEM-0115), Biopure Corporation with Quintiles, Inc., Clinical Event and Adjudication Services, 2000-2001. (multicenter, international, RCT). Status: closed

4) Member, Critical Endpoints Committee, Cerivastatin Heart Outcomes in Renal Disease:

Understanding Survival (C.H.O.R.U.S.), Barry Brenner, MD and William F. Keane, MD, Co-Principal Investigators, Bayer Inc., 2000-2003 (multicenter, international, RCT). Status: study terminated early due to drug withdrawal from market

5) Member, Clinical Events Classification Committee, Correction of Hemoglobin and Outcomes

in Renal Insufficiency (CHOIR), Ajay Singh, MD, Donal Reddan, MBBS, Principal Investigators, Ortho Biotech Inc., 2001-2004 (multicenter, international, RCT). Status: closed

6) Member, Critical Endpoint Committee, A Randomised, Double-blind, Parallel Group, Phase

3, Efficacy and Safety Study of AZD6140 (Ticagrelor) Compared with Clopidogrel for Prevention of Vascular Events in Patients with Non-ST or ST Elevation Acute Coronary Syndromes (ACS) [PLATO – A Study of PLATelet inhibition and Patient Outcomes.], AstraZeneca, Inc., Duke Clinical Research Institute, 2008, status: closed

7) Chair, Clinical Endpoints Committee, Alere San Diego, Inc, Alere Prospective Blinded Study

of a Novel Troponin Assay (PEARL), status: closed 2015

8) Chair, Adjudication Committee, Myeloperoxidase In the Diagnosis of Acute coronary Syndromes (MIDAS) study, Alere, Inc., status: closed 2012

9) Independent Endpoint Adjudicator, BioPorto Diagnostics, The NGAL test as an aid for the

Diagnosis of AKI in an Intensive Care Population, Code of the Study: KLIN 12-005, status closed, 2015

10) Independent Endpoint Adjudicator, Ischemix, Inc., Safety and Efficacy of CMX-2043 for

Protection of the Heart and Kidneys in Subjects Undergoing Coronary Angiography (CARIN), status: closed 2016

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11) Chair, Data Adjudication Committee, Estimating versus Measuring Plasma Volume and Kidney Function in Acute Decompensated Congestive Heart Failure, Eudra-CT Number 2018-002638-18, Sponsor: Charite-Unversitatsmedizin Berlin, FAST Biomedical, Inc, 2018-present

Overall Study Responsibilities: Data Safety Monitoring Committees 1) Member, External Advisory Committee/Data Safety Monitoring Board, National Institutes of

Health, National Institute of Diabetes and Digestive and Kidney Diseases, Polycystic Kidney Disease (PKD) Clinical Trials Network HALT-PKD Trial, Robert Schrier, MD, Principal Investigator, Committee Chair: William Henrich, MD, 2004-2008, Data Safety Monitoring Board, status: closed 2014

2) Chairman, Data Safety Monitoring Committee, Clinical Trials Program CS0011-A-U301, Daiichi Sankyo Pharma Development (DSPD) CS-011, Seven Core Trials of Rivoglitazone in Type 2 Diabetes: 1) A 26-week placebo-controlled trial of 1.0 and 1.5 mg rivoglitazone vs. 45 mg pioglitazone, as monotherapy in type 2 diabetics (CS0011-A-U301); 2) A 26-week placebo-controlled trial of 0.5, 1.0 and 1.5 mg rivoglitazone vs. 15, 30 and 45 mg pioglitazone, as monotherapy in type 2 diabetics (CS0011-A-U302); 3) A 26-week placebo-controlled trial of 1.0 and 1.5 mg rivoglitazone vs. 45 mg pioglitazone, in type 2 diabetics on metformin therapy, followed by a 26-week pioglitazone-controlled continuation period (CS0011-A-U303); 4) A 26-week placebo-controlled trial of 0.5 and 1.0 rivoglitazone vs. 30 mg pioglitazone, in type 2 diabetics on sulfonylureas therapy, followed by a 26-week pioglitazone-controlled continuation period (CS0011-A-U304); 5) A 26-week placebo-controlled trial of 0.5 and 1.0 mg rivoglitazone vs. 15 mg pioglitazone in type 2 diabetics on insulin therapy (CS0011-A-U305); 6) A long-term (12-24 months) randomized, general efficacy and safety study of rivoglitazone vs. pioglitazone, as monotherapy or add-on therapy, in type 2 diabetics (CS0011-A-U306); 7) A 26-week placebo-controlled trial of rivoglitazone and metformin, in type 2 diabetics (CS0011-A-U307), USFDA Special Protocol Assessment Agreement granted, status: closed, 2009 trials program terminated

3) Member, Data Safety Monitoring Committee, A Multicenter, Randomized, Double-Blind,

Placebo-Controlled Study to Evaluate Cardiovascular Outcomes Following Treatment with Alogliptin in Addition to Standard of Care in Subjects with Type 2 Diabetes and Acute Coronary Syndrome SYR322_402, EXAMINE Trial Takeda Global Research and Development Center, Inc. (US) Takeda Global Research and Development Centre, Ltd. (Europe), status: 2009 trial stopped early for non-inferiority but futility on superiority outcome

4) Chair, Data Safety Monitoring Committee, Protocol D9120C00019, A randomised, double-

blind, placebo controlled, multi-centre phase IIb dose finding study to assess the effect on GERD symptoms, safety and tolerability during four weeks treatment with AZD3355 in doses 60 mg, 120 mg, 180 mg and 240 mg bid as add-on treatment to a PPI in patients with GERD that are partial responders to PPI treatment, AstraZeneca, status: closed 2009, trials program terminated for safety

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5) Member, Data Safety Monitoring Committee, Protocols: AMAG-FER-IDA-301, A Phase III,

Randomized, Double-Blind, Placebo-Controlled Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia, Protocol: AMAG-FER-IDA-302, A Phase III, Randomized, Open-Label, Active Controlled Trial Comparing Ferumoxytol with Iron Sucrose for the Treatment of Iron Deficiency Anemia, Protocol: AMAG-FER-IDA-303, A Phase III, Open-Label Extension, Trial of the Safety and Efficacy of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia, AMAG Pharmaceuticals, Inc., status: closed 2010, trial completed in 2013 without safety concerns

6) Chair, Independent Data Monitoring Committee, Protocol 402-C-0903 Bardoxolone Methyl

Evaluation in Patients with Chronic Kidney Disease and Type 2 Diabetes: the Occurrence of Renal Events (BEACON), Reata Pharmaceuticals, Inc., status: trial stopped in 2012 early for cardiovascular and mortality safety concerns

7) Member, Independent Safety Council, Affymax Inc and Takeda Pharmaceutical Co.,

Omontys (peginesatide), status: closed, post-marketing surveillance led to voluntary drug withdrawal from market in 2013 for serious and fatal allergic reactions

8) Chair, Independent Data Monitoring Committee, AbbVie, Inc, Clinical Study Protocol M11-

352 A Randomized, Multicountry, Multicenter, Double Blind, Parallel, Placebo-Controlled Study of the Effects of Atrasentan on Renal Outcomes in Subjects with Type 2 Diabetes and Nephropathy SONAR: Study Of Diabetic Nephropathy with Atrasentan, status closed 2018

9) Chair, Independent Data Monitoring Committee, AbbVie, Inc., Clinical Study Protocol M13-

958 A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Trial of Multiple Dosing Regimens of ABT-719 for the Prevention of Acute Kidney Injury in Subjects Undergoing High Risk Major Surgery, status: closed 2015

10) Member, Data Monitoring Committee, Akebia Therapeutics, Inc., AKB-6548-CI-0007, Phase

2b Randomized, Double-Blind, Placebo-Controlled Study to Assess the Pharmacodynamic Response, Safety, and Tolerability to 20 Weeks of Oral Dosing of AKB-6548 in Subjects with Anemia Secondary to Chronic Kidney Disease (CKD), GFR Categories G3a-G5 (Stages 3, 4, and 5) (Pre-Dialysis), status: closed 2015

11) Member, Study Monitoring Team, Akebia Therapeutics, Inc., AKB-6548-CI-0011, Phase 2a

Open-Label Study to Assess the Efficacy, Safety, and Tolerability of AKB-6548 in Subjects with Anemia Secondary to End Stage Renal Disease (ESRD), Undergoing Chronic Hemodialysis, status: closed 2016

12) Member, Data Monitoring Committee, Merck, Inc., Pfizer, Inc, Clinical Trials Program,

Ertugliflozin (MK-8835/PF-04971729) Phase 2 and Phase 3 Development Program, status closed, 2012 to 2020

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13) Member, Steering Committee, Medtronic, Inc., Monitoring in Dialysis, status: closed 2016

14) Member, Data Safety and Monitoring Board, St. Jude Medical, EnligHTN IV Multi-center, randomized, single-blind, sham controlled clinical investigation of renal denervation for uncontrolled hypertension, status: 2013 trial terminated before recruitment started

15) Chair, Data Safety Monitoring Board, Neumedicines, Inc., A Phase 2, Single-Dose,

Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HemaMax™ (rHuIL-12) in Healthy Subjects, status: closed 2016

16) Chair, Data Safety Monitoring Board, Reata Pharmaceuticals, Inc., A Phase 2 Study of the

Safety, Efficacy, and Pharmacodynamics of RTA 408 in the Treatment of Friedreich’s Ataxia, 2014 to 2019, status: closed

17) Chair, Data Safety Monitoring Board, Reata Pharmaceuticals, Inc., A Phase 2 Study of the

Safety, Efficacy, and Pharmacodynamics of RTA 408 in the Treatment of Mitochondrial Myopathy, 2015 to 2019, status: closed

18) Member, Patient Safety Review Committee, Reata Pharmaceuticals, Inc, A dose-ranging

study of the efficacy and safety of Bardoxolone Methyl in patients with pulmonary arterial hypertension (402-C-1302), 2014 to 2018, status: closed

19) Chair, Data Safety Monitoring Board, Reata Pharmaceuticals, Inc., A Study of the Efficacy

and Safety of Bardoxolone Methyl in Patients with Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (CATALYST), 2016 to present, status: closed

20) Chair, Data Safety Monitoring Board, Reata Pharmaceuticals, Inc., A Phase 2/3 of Efficacy

and Safety of Bardoxolone Methyl in Patients with Alport Syndrome (CARDINAL), 2017 to present, status: closed

21) Chair, Data Safety Monitoring Board, Sanfit, Inc., A double-blind, randomised, placebo-

controlled study to assess the effect of SNF472 on progression of cardiovascular calcification on top of standard of care in end-stage-renal-disease (ESRD) patients on haemodialysis (HD) SNFCT2015-05, 2017 to 2019, status: closed

22) Chair, Data Monitoring Committee, Renew Research, KAI Research, A Randomized Pivotal

Study of RenewTM NCP-5 for the Treatment of Mild Cognitive Impairment due to Alzheimer’s Disease or Mild Dementia of the Alzheimer’s Type, 2018 to present, status: closed

23) Chair, Data Safety Monitoring Committee, Sanofi, Inc, Multicenter, randomized, double-

blind, placebo-controlled two stage study to characterize the efficacy, safety, tolerability and pharmacokinetics of GZ/SAR402671 in patients at risk of rapidly progressive Autosomal

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Dominant Polycystic Kidney Disease (ADPKD) STUDY NUMBER: EFC15392 STUDY NAME: SAVE-PKD COMPOUND: GZ/SAR402671, 2018 to present, status: open

24) Chair, Data Safety Monitoring Board, National Institutes of Health, National Heart, Lung and

Blood Institute R34 NHLBI Clinical Trial Pilot Studies (R34) Reducing Arrhythmia in Dialysis by Adjusting the Rx Electrolytes/Ultrafiltration (RADAR), David Charytan, MD, PI, 2019 to present, status: open

25) Chair, Data Safety Monitoring Board, GZ402671 EFC15392 Multicenter, randomized,

double-blind, placebo-controlled two stage study to characterize the efficacy, safety, tolerability and pharmacokinetics of GZ/SAR402671 in patients at risk of rapidly progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD), Sanofi, status: open

26) Chair, Data Safety Monitoring Board, MEDI3506, Trials Portfolio, D9182C00001 A Phase 2

Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy and Safety of MEDI3506 in Adult Subjects with Moderate-to-severe Atopic Dermatitis; D9181C00001 A Phase II, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of MEDI3506 in Adult Participants with Uncontrolled Moderate-to-severe Asthma; D9180C00002 A Phase II, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety and Tolerability of MEDI3506 in Participants with Moderate to Severe Chronic Obstructive Pulmonary Disease and Chronic Bronchitis (FRONTIER 4); D9183C00001 A Phase 2b Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of MEDI3506 in Subjects with Diabetic Kidney Disease, Axio Inc, A Cytel Company, status: open

GRANT AWARDS Original Research Grants

G1)London JF (PI), Bis KG, Juni JE, Wilke N, DiCarli MF, Shetty AN, McCullough PA, Timmis GC.

Magnetic Resonance vs. Positron Emission Tomography for the Detection of Myocardial Viability. Bracco Diagnostics Inc./SCA&I Grant, $25,000 (WBH RC-453), 1997-98. Additional WBH Research Institute Mini-grant, $5,000 (WBH Grant #RC-748). Level of involvement: author of the variable definitions, endpoints, and data analysis sections, 0% FTE. Status: closed 1998

G2)McCullough PA (PI), Shah S, Noor H, Marks KR, McCabe KB, Zong L, McCord J, Khoury N,

Ulcickas-Yood M, Ward RE. Diagnostic Accuracy of an Emergency Department Clinical Decision Unit in the Evaluation of Chest Pain. HFHS Small Projects Fund $10,000 (HFHS Grant #A30785), 0% FTE. Status: closed 1997

G3)Keteyian SJ (Co-PI), McCullough PA (Co-PI), Brawner CA, Rosman HS, Stein P, Weaver WD. A

Prospective Study of Case Identification and Triage of Patients Eligible for Cardiac

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Rehabilitation. Merck & Co., U.S. Human Health, $30,000 (HFHS Grant #E18037), 3% FTE. Status: closed 1998

G4)McCullough PA. Novel Methods for Identifying High-Risk Patients for Subsequent

Cardiovascular Events. Merck & Co., U.S. Human Health, $20,000 (HFHS Grant #M1060), 0% FTE. Status: closed 1998

G5)McCullough PA. Cardiovascular Informatics Development Award. Pfizer, Inc., $10,000

(HFHS Grant #E60022), 0% FTE. Status: closed 1998

G6)McCullough PA, Yee J, Soman S, Sallach J, Borzak S, Foreback C, Monaghan K, Tisdale JE, Bailey E, Bola P, Chase G, Marks KR, Weaver WD. A Prospective Dose-Ranging Trial of Folic Acid to Reduce Total Homocyst(e)ine Levels in Patients with End-Stage Renal Disease Undergoing Hemodialysis. HFHS Project Development Fund $10,000 (HFHS Grant #A20003), 0% FTE. Status: closed 1999

G7)McCullough PA. NuStep Recumbent Cross Trainer Product Development Pilot Study,

NuStep, Inc., (single center, prospective pilot study), $12,500.00, (WBH Grant #RC- 08-94847). Status: closed 2005

G8)McCullough PA, Secondary Analyses from the PRINCE Trial, (single center data analysis),

$20,000, PLC Medical, Inc., (WBH #RC 08-94851) Status: closed 2005

G9)McCullough PA, Sullivan RA. A Systematic Review of Vascular Calcification in Patients with Chronic Kidney Disease and End-Stage Renal Disease, 2002-2003, Braintree Labs, Inc., $40,000, 25% FTE (WBH Grant #RC 08-94833) Status: closed 2003

G10) Pasas SA, Davies MI, McCullough PA. Determination of Protein-bound Homocysteine

in Human Plasma using Capillary Electrophoresis with Electrochemical Detection in Patients with Chronic Kidney Disease, 2003-2004, AHA Predoctoral Fellowship Program (Pasas), $38,000, 15% FTE (UMKC Grant #). Status: closed 2003

G11) Collins AC, Gladstone E, Robitscher JW, McCullough PA, Klag M, Narva A, Gilberston

D for the NKF. Demonstration project: state-based screening for chronic kidney disease. Response to CDC-RFA-DP06-004, demonstration project for identifying individuals at high-risk for CKD in the US. Centers for Disease Control, $1,199,609, 12% FTE Status: closed 2007

G12) McCullough PA, Principal Investigator. Neutrophil Gelatinase-Associated Lipocalin

(NGAL): A Novel Blood Marker for Risk of Developing Contrast-Induced Nephropathy (ENCINO). Biosite/Inovise, Inc., $229,000.00 (WBH #RC-94862), 0% FTE Status: closed 2009

G13) Agrawal V, Barnes M, McCullough PA. Evaluation of CKD awareness in medical

residents. WBH intramural mini-grant R/C# 98662, $10,000.00, 0% FTE Status: closed 2008

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G14) McCullough PA, overall Principal Investigator transferred to Zalesin K. FDA

Investigational New Drug Exemption (INDE) #060672. A Prospective, Randomized, Placebo-Controlled, Parallel-Group, Pilot Trial of Paricalcitol in the Treatment of Hyperparathyroidism in Patients after Roux-en-Y Gastric Bypass Surgery with Chronic Kidney Disease, Abbott Laboratories, Inc., $496,600.00 (WBH #RC-90290), 0% FTE Status: closed 2009

G15) McCullough PA, overall Principal Investigator transferred to Miller WM, FDA INDE

#107750. Investigator Initiated Study. A Prospective, Double-Blind, Randomized, Parallel Group, Placebo-Controlled Trial of Aliskiren versus Placebo in Non-Diabetic, Normotensive Obese Patients with Microalbuminuria, Novartis, Inc., $339,400.00 (WBH #RC-90345), Status: closed 2010

G16) McCullough PA, overall Principal Investigator. Investigator Initiated Study, FDA

Investigational New Drug (IND) #74707. A Phase 2, randomized, double-blind, placebo-controlled trial, to assess the efficacy and safety of deferiprone in the reduction of markers of contrast-induced acute oxidative kidney injury. Cormedix, Inc, $857,745 (includes $101,442 for Beaumont Research Coordinating Center). Study centers included Providence Hospital and Medical Center Southfield, St. John Hospital and Medical Center, Detroit, Northern Michigan Hospitals, Petoskey, MI, St. Vincent’s Hospital, Indianapolis, IN, Fairfield Cardiac Cath Labs, LLC, Fairfield, OH, Oklahoma Heart Hospital, Oklahoma City, OK, Ohio Health Research Institute, Columbus, OH, Mercy St. Vincent Hospital, Toledo, OH, Status: closed 2011

G17) McCullough PA, overall study Principal Investigator, A Prospective Randomized

Parallel-Group Controlled Trial of Multiple Blood Biomarkers in the Personalized Management of Chronic Heart Failure, Baylor IRB 014-252, Baylor Foundation, 2014, $78,639.20, status: closed 2016.

G18) McCullough PA, overall study Principal Investigator, Baylor Hypertrophic

Cardiomyopathy Program Development Project: Time-resolved, 3D phase contrast magnetic resonance imaging (MRI) (4D Flow) and Advanced Strain Rate Echocardiography in Patients with Hypertrophic Cardiomyopathy, Baylor IRB 014-175, Baylor Foundation, 2014, $100,000.00, status: open

G19) McCullough PA, overall study Principal Investigator, Preventive Cardiology Registry:

Role of Proprotein Convertase Subtilisin/kexin type 9 (PCSK9) and Other Catabolic Determinants in Hypercholesterolemia in Patients with Suspected Heterozygous Familial Hypercholesterolemia Baylor IRB 014-122, Baylor Foundation, $3,100.00, status: closed 2014

G20) McCullough PA, overall study Principal Investigator and Study Chairman, Investigator

Initiated Trial, “A Prospective, Double-blind, Placebo Controlled, Parallel Group,

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Randomized Trial of Extended Release Exenatide versus Placebo in Diabetic Patients with Type 4 Cardiorenal Syndrome: EXTEND-CRS”, D5551L00004/ISSEXEN0013, FDA IND 123200, Baylor IRB 014-149, AstraZeneca, 2014, $1,597,901.93, status: open

G21) McCullough PA, overall study Principal Investigator, Iso-osmolar Contrast and the Timing of Coronary Angiography in the Multivariate Risk for Cardiac Surgery Associated with Acute Kidney Injury and Major Adverse Renal and Cardiac Events (MARCE), Baylor IRB 014-096, GE Healthcare, Inc, 2015, $145,885.00, status open

G22) McCullough PA, overall study Principal Investigator, Timing of coronary angiography

and multivariate risk for cardiac surgery associated acute kidney injury and major adverse renal and cardiac events (MARCE), Baylor IRB 014-096, Baylor Foundation, $8,100.00, status: closed 2016

G23) Mendez J, McCullough PA, et al, co-investigator, Assessment of Multiple Blood

Biomarkers in Patients with Advanced Heart Failure Undergoing Evaluation for Cardiac Transplantation and Mechanical Circulatory Support, Baylor IRB 014-300, Critical Diagnostics, Inc, $10,400.00, status: closed 2016

G24) Bottiglieri, T, McCullough PA, et al, co-investigator, Urinary 11dhTxB2 response to

acetylsalicylic acid (aspirin) in cardiovascular disease progression and adverse outcomes, Baylor IRB 008-230, Corgenix, Inc., $99,087.00, status: closed 2016

G25) Schussler JM, Vasudevan A, McCullough PA, co-investigator, Clinical outcomes and

metabolomic and damage associated molecular patterns of acute kidney injury in patients undergoing percutaneous coronary intervention via the radial versus femoral artery approach, Baylor IRB 014-299, Baylor Health Care System Foundation, $61,416.00, status: closed 2018

G26) Tecson K, McCullough PA, coinvestigator, Contribution of Chronic Kidney Disease and

Acute Kidney Injury to Heart Failure Outcomes, Baylor IRB 015-296, Baylor Health Care System Foundation, $43,424.60, status: open

G27) Vasudevan A, McCullough PA, coinvestigator, Burden of Cardiovascular Events Follow

Percutaneous Coronary Intervention, Baylor IRB 015-297, Baylor Health Care System Foundation, $40,000.00, status: closed 2018

G28) Tecson, K, McCullough PA, Therapeutic Intensity of Lipid Lowering Therapy in

Response to Recurrent Cardiovascular Events, Baylor IRB 017-106, Amgen, Inc., $249,990.00 status: open

G29) McCullough PA, Principal Investigator, A Case Finding Study of Familial

Chylomicronemia, Akcea Pharmaceuticals, $10,000.00, status: closed 2017

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G30) McCullough PA, Bottiglieri T, Tecson K. Baylor Foundation $49,923.80. Identifying metabolomic profiles among genetically confirmed familial hypercholesterolemia, dyslipidemia without familial hypercholesterolemia, and healthy controls, status start-up 2019

Site Principal Investigator Contracts

G1)Jafri S, McCullough PA, and the WATCH Investigators. Warfarin and Antiplatelet Therapy in Chronic Heart Failure, (W.A.T.C.H.) Field Center, Veterans Administration Cooperative Studies Program and Sanofi Pharmaceuticals, $36,000.00 (HFHS Grant #B51008) status: closed 2000

G2)Jafri S, McCullough PA, and the CHARM Investigators. Candesartan Cilexetil (Candesartan)

in Heart Failure Assessment of Reduction in Mortality and Morbidity (C.H.A.R.M.) Field Center, 1999-2000, Astra Pharmaceuticals, $56,000.00 (HFHS Grant #E09045) status: closed 2000

G3)Schuger C, McCullough PA, and the MADIT Investigators. Multicenter Automatic

Defibrillator Implantation Trial II (M.A.D.I.T.-II), Guidant Corporation/Cardiac Pacemakers (CPI), $96,000 (HFHS Grant #G10087) status: closed 2000

G4)Schuger C, McCullough PA, and the MIRACLE Investigators. Multicenter InSync Randomized

Clinical Evaluation (M.I.R.A.C.L.E.), Medtronic Inc., $195,000, (HFHS Grant #G12006) status: closed 2000

G5)McCullough PA, Shetty A, Soman S and the CHORUS Investigators. Cerivastatin Heart

Outcomes in Renal Disease: Understanding Survival (C.H.O.R.U.S.), Barry Brenner, MD and William F. Keane, MD, Co-Principal Investigators, Bayer Inc., 2000-2003 (RCT), Clinical Site Contract, Bayer Pharmaceuticals, $266,875.00 10% FTE (HFHS Grant #E05046) status: closed 2000

G6)McCullough PA, Manley HJ and the CHORUS Investigators. Cerivastatin Heart Outcomes in

Renal Disease: Understanding Survival (C.H.O.R.U.S.), Barry Brenner, MD and William F. Keane, MD, Co-Principal Investigators, Bayer Inc., 2000-2003 (RCT), Clinical Site Contract, Bayer Pharmaceuticals, $279,000 10% FTE (UMKC Grant #E05046) status: closed 2001

G7)Nowak R, McCord J, McCullough PA and the BNP Investigators. Breathing Not Properly

Study (B.N.P. Multinational Study), Alan Maisel, MD, and Peter A. McCullough, MD, MPH, Co-Principal Investigators, Biosite Diagnostics, Inc., (prospective cohort study) Field Center Contract, Biosite Diagnostics, Inc., $180,000.00 (HFHS Site), $500,000.00, 0% FTE (HFHS Grant #E03005) status: closed 2001

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G8)Ehrman JK, McCullough PA. A Prospective Randomized Trial of a Personal Health Assistant in the Secondary Prevention of Heart Disease. Merck, Inc., $220,961.00, 7% FTE (HFHS Grant #E41010) status: closed 2002

G9)McCullough PA and the CORC Investigators. Kansas City Cardiomyopathy Questionnaire

Interpretability Study, John A. Spertus, MD, MPH, Principal Investigator, Cardiovascular Outcomes Research Consortium (C.O.R.C.), 2001 (multicenter, U.S., prospective cohort study), $21,400.00, status: closed 2002

G10) McCullough PA, Rutherford BD, and the OAT Investigators. Occluded Artery Trial,

Judith Hochman, MD, and Gervasio Lamas, MD, Co-Principal Investigators, National Institutes of Health, National Heart Lung and Blood Institute, $54,000.00. 0% FTE (UMKC Grant #K531122) status: closed 2002

G11) McCullough PA site Principal Investigator and National Executive Committee

Member. Rapid Emergency Department Heart Failure Outpatient Trial, Biosite Diagnostics, $21,000. 0% FTE (UMKC Grant #K531130) status: closed 2002

G12) McCullough PA site Principal Investigator. African-American Heart Failure Trial

(AHEFT). A Placebo-Controlled Trial of BiDil added to Standard Therapy in African American Patients with Heart Failure, NitroMed, Inc., $20,000.00 (UMKC Proposal #9722, TMC Grant #261231) status: closed 2002

G13) McCullough PA and the IMAGING Investigators for Cardiology Clinical Studies, LLC.

Investigation of Myocardial Gated SPECT Imaging as Initial Strategy in Heart Failure: The IMAGING in Heart Failure Trial, Dupont Pharmaceuticals Inc., $20,000.00 (UMKC Proposal #9825, UMKC Grant #KG001278) status: closed 2002

G14) McCullough PA, site Principal Investigator, and Ad Hoc Executive Committee

Member. Heart Failure and a Controlled Trial Investigating Outcomes of Exercise Training. National Institutes of Health, National Heart, Lung, and Blood Institute, subcontracted through the Duke Clinical Research Institute, $665,000, (NIH Grant #1 U01 HL63747 01A2, WBH Grant # RC 08-94837, Site #301) status: closed 2005

G15) McCullough PA, site Principal Investigator, and Executive Committee Member.

Protocol No. 704.351 Evaluation of Synergy between Natrecor and Furosemide on Renal and Neurohormone Responses in Chronic Heart Failure: A Phase IV Study, Scios Inc., 2003 (multicenter, U.S., randomized cross-over trial), $105,447.50, (WBH Grant # RC 08-94836) status: closed 2005

G16) McCullough PA, site Principal Investigator and National Co-Principal Investigator.

Protocol No. CCIB002FUS12. A Multicenter, Double-blind, Randomized, Parallel Group Study to Evaluate the Effects of Lotrel and Lotensin HCT on Microalbuminuria in Mild to

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Moderate Hypertensive Subjects with Type 2 Diabetes Mellitus, Novartis Inc., (multicenter, U.S., randomized trial), $63,649.90, (WBH Grant #RC 08-94838) status: closed 2006

G17) McCullough PA, and the ACCOMPLISH Investigators. Protocol No. CCIB002.12301.

Avoiding Cardiovascular Events through Combination Therapy in Patients Living with Systolic Hypertension, Novartis, Inc., 2003 (multicenter, multinational, randomized trial) $159,241.00, (WBH Grant #RC 08-94844) status: closed 2006

G18) McCullough PA, site Principal Investigator. Efficacy of Vasopressin Antagonism in

Heart Failure: Outcome Study with Tolvaptan, Protocol #156-03-236, IND #50,533, Otsuka Maryland Research Institute, (multicenter, international, randomized trial), $210,750.00, (WBH Grant #RC 08-94842 changed to #RC 08-94849) status: closed 2005

G19) McCullough PA, site Principal Investigator. A Multicenter, Double-Blind,

Randomized, Parallel Group, 6-week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Combination versus Atorvastatin in Patients with Hypercholesterolemia, Protocol #051/EZT544, Merck, Inc., (multicenter, U.S., randomized trial), $18,840.00, (WBH Grant #RC 08-94843) status: closed 2006

G20) McCullough PA, site Principal Investigator, A multicenter, double-bind randomized,

parallel-group study to compare the effect of 24 weeks treatment with LAF237 (50 mg qd or bid) to placebo as add-on therapy in patients with type 2 diabetes inadequately controlled with metformin monotherapy. Novartis Pharmaceuticals, Inc., (multicenter, U.S., randomized trial), $30,700.00, (WBH Grant #RC 08-94845) status: closed 2007

G21) McCullough PA, site Principal Investigator. A multicenter, double-bind randomized,

parallel-group study to compare the effect of 24 weeks treatment with LAF237 (50 mg qd or bid) to placebo as add-on therapy to pioglitazone 45 mg qd in patients with type 2 diabetes inadequately controlled with thiazolidinediones monotherapy. Novartis Pharmaceuticals, Inc., (multicenter, U.S., phase III randomized trial) $30,700.00, (WBH Grant #RC 08-94846) status: closed 2006

G22) McCullough PA, site Principal Investigator. An 8-week, randomized, double-blind,

parallel group, multicenter placebo and active controlled disease escalation study to evaluate the safety and efficacy of aliskiren in patients with hypertension, $47,100.00 (WBH #RC 08- 94852) status: closed 2007

G23) McCullough PA, site Principal Investigator. A randomized, double-blind study to

compare the durability of glucose lowering and preservation of pancreatic beta-cell function of rosiglitazone monotherapy compared to metformin or glyburide/glibenclamide in patients with drug naïve, recently diagnosed type 2 diabetes, $140,100.00, Novartis Pharmaceuticals (WBH #RC 08-94849) status: closed 2008

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G24) McCullough PA, site Principal Investigator. A multicenter, randomized, double-blind factorial study of the co-administration of MK-0431 and metformin in patients with type 2 diabetes who have inadequate glycemic control, $36,735.00, Merck Research Laboratories (WBH #RC 08-94853) status: closed 2008

G25) McCullough PA, site Principal Investigator. Multicenter, Randomized, Double-Blind

Study to Evaluate the Efficacy & Safety of Ezetimibe/Simvastatin and Niacin Co-Administered in Patients with type IIa or Type IIb Hyperlipidemia, $46,960.00, Merck Research Laboratories, MRK-091, (WBH #RC 08-94854) status: closed 2008

G26) McCullough PA, site Principal Investigator. A Multi-Center, Randomized, Double-

Blind, factorial Design study to evaluate the lipid-altering efficacy & safety of MK-0524B Combination Tablet in Patients with Primary Hypercholesterolemia or Mixed Hyperlipidemia $40,849.00, Merck Research Laboratories, MRK-022. (WBH #RC 08-94855) status: closed 2007

G27) McCullough PA, site investigator. An 8-week, multicenter, randomized, double-blind,

parallel-group study to evaluate the efficacy and safety of the combination of valsartan/HCTZ/amlodipine compared to valsartan/HCTZ, valsartan/amlodipine, and HCTZ/amlodipine in patients with moderate to severe hypertension, $43,500.00, Novartis Pharmaceuticals (WBH #RC 08-94857) status: closed 2007

G28) McCullough PA, site Principal Investigator. A multicenter randomized, double-blind

parallel arm, 6-week study to evaluate the efficacy and safety of ezetimibe/simvastatin versus atorvastatin in patients with metabolic syndrome and hypercholesterolemia at high risk for coronary heart disease, $32,010.00. Merck Research Laboratories (WBH #RC 08-94861) status: closed 2008

G29) McCullough PA, site Principal Investigator. A multicenter, randomized, double-blind

study to evaluate the safety and efficacy of the initial therapy with coadministration of sitagliptin and pioglitazone in patients with type 2 diabetes mellitus, $24,036.00, Merck Research Laboratories, MRK-064 (WBH #RC 08-94860) status: closed 2008

G30) Dixon, SD, site PI, McCullough PA, Multinational Executive Committee. RENAL

GUARD Pilot Trial. PLC Medical Systems, $37,610.00 (WBH #RC- 90771) status: closed 2008 G31) McCullough, PA, site Principal Investigator, A multi-center, randomized, double-

blind, placebo and active controlled, parallel group, dose range study to evaluate the efficacy and safety of LCZ696 comparatively to valsartan, and to evaluate AHU377 to placebo after 8-week treatment in patients with essential hypertension. Novartis, Inc., $31,965.28. (WBH #RC-94863) status: closed 2008

G32) McCullough PA, site Principal Investigator. Paricalcitol capsules benefits in renal

failure induced cardiac morbidity in subjects with chronic kidney disease stage 3b/4,

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(PRIMO Abbott Laboratories, ABT-M-10-030, $157,992.00, (WBH #RC-94864) status: closed 2008

G33) McCullough PA, site Principal Investigator. A randomized, double-blind, parallel

group study to evaluate the effects of high-dose statin therapy on fluorodeoxyglucose (FDG) uptake in arteries of patients with atherosclerotic vascular disease. Merck Research Laboratories, MRK-081, $86,994.00 (WBH #RC 08-90223) status: closed 2008

G34) McCullough PA, site Principal Investigator. Patient registry for the Liposorber LA-15

system. Kaneka, Inc., $7,515.00, (WBH #RC-90877) status: closed 2009 G35) McCullough PA, site Principal Investigator. A 30-week multicenter, randomized,

double-blind. Parallel-group study of the combination of ABT-335 and Rosuvastatin compared to rosuvastatin monotherapy in dyslipidemic subjects with stage 3 chronic kidney disease, Abbott M10-313, $128,544.00, (WBH #RC-90212) status: closed 2009

G36) McCullough PA, site Principal Investigator. A multicenter, randomized open label,

active-comparator controlled study to assess the efficacy, safety, and tolerability of taspoglutide compared to exenatide in patients with type 2 diabetes mellitus inadequately controlled with metformin, thiazolidinedione, or a combination of both, Roche BC 21625, $72,012.50, (WBC #RC-90245) status: closed 2010

G37) McCullough PA, site Principal Investigator. A multicenter, randomized double-blind,

placebo-controlled study to assess the efficacy, safety, and tolerability of taspoglutide compared to placebo in obese patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy, Roche BC 22092, $38,387.50, (WBH #RC-90258) status: closed 2009

G38) McCullough PA, site Principal Investigator. A safety and efficacy trial evaluating the

use of apixaban for the extended treatment of deep vein thrombosis and pulmonary embolism, Bristol Myers Squibb-Pfizer CV185057, $173,750.00, (WBH #RC-90288) status: closed 2009

G39) McCullough PA, site Principal Investigator. A phase 3, active (warfarin) controlled,

randomized, double-blind, parallel arm study to evaluate efficacy and safety of apixaban in preventing stroke and systemic embolism in subjects with nonvalvular atrial fibrillation, Bristol Myers Squibb-Pfizer CV1805030, $173,750.00, (WBH #RC-90275) status: 2009

G40) McCullough PA, site Principal Investigator. Treatment of Preserved Cardiac Function

Heart Failure with an Aldosterone Antagonist Trial (TOPCAT), National Institutes of Health, National Heart, Lung, and Blood Institute, subcontracted through the New England Research Institutes, Inc., $86,250.00, (WBH #RC-90267) status: closed 2010

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G41) McCullough PA, site Principal Investigator. An 8-week, randomized, double-blind, parallel group, multicenter, forced titration study to evaluate the efficacy and safety of aliskiren plus HCTZ verus aliskiren monotherapy in metabolic syndrome patients with stage 2 hypertension, Novartis, Inc., $107,362.44 (WBH #RC-90277) status: closed 2009

G42) McCullough PA, site Principal Investigator, Astute SAPPHIRE AST-111, Evaluation of

Novel Biomarkers from Acutely Ill Patients at Risk for Acute Kidney Injury, Astute Medical, Inc, San Diego, CA, $23,195.50 status: closed 2012

G43) McCullough PA, site Principal Investigator, protocol number 156-10-292 titled “An

Observational Prospective Registry to Identify Demographic and Clinical Characteristics of Patients Hospitalized with Euvolemic and Hypervolemic Hyponatremia and Assess the Comparative Effectiveness of Available Treatments and the Impact on Resource Utilization. Otsuka Inc., $21,262.60 status: initial contract fulfilled, reopened under extension and registry completed in 2013

G44) McCullough PA, site Principal Investigator, PROspective Multicenter Imaging Study

for Evaluation of Chest Pain (PROMISE) Study, National Heart, Lung, and Blood Institute (NHLBI), Pamela Douglas, MD, Principal Investigator Clinical Coordinating Center, Duke Clinical Research Institute, $17,000.00 status: closed 2012

G45) McCullough PA, site Principal Investigator, ACZ885M/Canakinumab Clinical Trial

Protocol CACZ885M2301 A randomized, double-blind, placebo-controlled, event-driven trial of quarterly subcutaneous canakinumab in the prevention of recurrent cardiovascular events among stable post-myocardial infarction patients with elevated hsCRP. Novartis, Inc., 2011 $279,223.00 status: closed 2015

G46) McCullough PA, site Principal Investigator, AN-CVD2233 Evaluation of the Safety and

Efficacy of Short-term A-002 (Varespladib) Treatment in Subjects with Acute Coronary Syndromes (VISTA-16) Anthera Pharmaceuticals, Inc., 2011 $72,600.00 status: closed 2011

G47) McCullough PA, site Principal Investigator, BC22140A Cardiovascular outcomes study

to evaluate the potential of aleglitazar to reduce cardiovascular risk in patients with a recent acute coronary syndrome (ACS) event and type 2 diabetes mellitus (T2D), F. Hoffmann-La Roche Ltd, $307,500.00 status: closed 2012

G48) McCullough PA, site Principal Investigator, A Double-blind, Randomized, Placebo-

controlled, Multicenter Study (Phase 2) to Evaluate the Safety and Efficacy of IV Infusion Treatment with Omecamtiv Mecarbil in Subjects with Left Ventricular Systolic Dysfunction Hospitalized for Acute Heart Failure (Protocol 20100754), Amgen, Inc, 253,464.00 status: closed 2012

G49) McCullough PA, site Principal Investigator, MB102-073 A Multicenter, Randomized,

Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and

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Efficacy of Dapagliflozin in Subjects with Type 2 Diabetes with Inadequately Controlled Hypertension on an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB), Bristol-Myers Squibb Research and Development, 2011 $34,115.00 status: closed 2012

G50) McCullough PA, site Principal Investigator, MB102-077 A Multicenter, Randomized,

Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Subjects with Type 2 Diabetes with inadequately controlled hypertension treated with an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB) and an additional Antihypertensive medication, Bristol-Myers Squibb Research and Development, $34,115.00 status: closed 2011

G51) McCullough PA, site Principal Investigator, ABT M11350 RADAR: Reducing Residual

Albuminuria in Subjects with Diabetes and Nephropathy with AtRasentan – A Phase 2b, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Safety and Efficacy, Abbott Laboratories, $188,377.00 status: closed 2012

G52) McCullough PA, site Principal Investigator, PEGASUS TIMI 54 trial, A Randomized,

Double-Blind, Placebo Controlled, Parallel Group, Multinational Trial, to Assess the Prevention of Thrombotic Events with Ticagrelor Compared to Placebo on a Background of Acetyl Salicylic Acid (ASA) Therapy in Patients with History of Myocardial Infarction, AstraZeneca, 2011 $98,530.00 status: transferred to PI Marcel Zughaib, MD

G53) McCullough PA, site Principal Investigator, A Double-blind, Randomized, Placebo-

controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When AMG 145 is Used in Combination with Statin Therapy in Patients with Clinically Evident Cardiovascular Disease AMG 145 Amgen Protocol Number 20110118 EudraCT number 2012-001398-97, Amgen, Inc., $1,732,062.80 status: closed 2016

G54) McCullough PA, site Principal Investigator, A single-blind, multi-site trial of the

dietary supplement anatabine (RCP006) to determine the effects on peripheral markers of inflammation in patients with elevated levels of C-reactive protein (CRP). Roskamp Institute Protocol Number RI-11-01, $6700.00 status: closed 2012

G55) McCullough PA, site Principal Investigator, Long-term safety and tolerability of

REGN727/SAR236553 in high cardiovascular risk patients with hypercholesterolemia not adequately controlled with their lipid modifying therapy: a randomized, double-blind, placebo-controlled study LTS11717 Sanofi Aventis, $252,000.00 status: closed 2013

G56) McCullough PA, site Principal Investigator, Assessment of Clinical Effects of

Cholesteryl Ester Transfer Protein Inhibition with Evacetrapib in Patients at a High Risk for Vascular Outcomes – the ACCELERATE Study, protocol I1V-MC-EIAN, Eli Lilly, $421,202.00 status: closed 2014

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G57) McCullough PA, site Principal Investigator, AEGR-733-025, LOWER: Lomitapide

Observational Worldwide Evaluation Registry, Aegerion, Inc., 2014, $23,478.00 status: open

G58) McCullough PA, site Principal Investigator, The Evaluation Of PF-04950615 (RN316), In Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects (SPIRE-1), Pfizer, Inc., $145,343.90 status: closed 2016

G59) McCullough PA, site Principal Investigator, The Evaluation Of PF-04950615 (RN316)

In Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects (SPIRE-2), Pfizer, Inc., $145,343.90 status: closed 2016

G60) McCullough PA, site Principal Investigator, Long Term Observational Study in Patients

with Homozygous Familial Hypercholesterolemia Treated with Kynamaro™, Genzyme-Sanofi, Inc., $61,260.00 status: closed 2018

G61) McCullough PA, site Principal Investigator, CUP14366, Alirocumab (SAR236553)

Expanded Access Program for the Treatment of Severe Hypercholesteremia Not Controlled with Maximal Tolerated Dose of Lipid Lowering Therapy Administered According to Standard of Care, Sanofi-Regeneron, Inc., 2015 $8,500.00 status: closed 2015

G62) McCullough PA, site Principal Investigator, Aspirin Dosing: A Patient-Centric Trial

Assessing Benefits and Long-term Effectiveness (ADAPTABLE), Patient-Centered Outcomes Research Institute, 2015 $29,400.00 status: open

G63) McCullough PA, site Principal Investigator, Assessment of Heart Failure using

Condition-Specific Impact Assessments (PROMIS), Patient-Centered Outcomes Research Institute, 2015 $81,840.00 status: 2017 status: closed

G64) McCullough PA, site Principal Investigator, A Randomized Parallel-Group, Placebo-

Controlled, Double-Blind, Event-Driven, Multi-Center Pivotal Phase III Clinical Outcome Trial of Efficacy and Safety of the Oral sGC Stimulator Vericiguat in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF) - VerICiguaT Global Study in Subjects With Heart Failure With Reduced Ejection Fraction (VICTORIA), Merck, Inc, 2017 $878,163.90 status: closed

G65) McCullough PA, site Principal Investigator, A phase III randomised, double-blind trial

to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure with preserved Ejection Fraction (HFpEF), EMPEROR-PRESERVED, Boehringer-Ingleheim, 2017 $170,099.00, status: open

G66) McCullough PA, site Principal Investigator, A phase III randomised, double-blind trial

to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in

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patients with chronic Heart Failure with preserved Ejection Fraction (HFpEF), EMPEROR-REDUCED, Boehringer-Ingleheim, 2017 $170,099.00, status: open

G67) Schiffmann R, McCullough PA Sub-Investigator, 014-097 PB-102-F03 (Sponsor -

Protalix - PRX-102 1mg/kg q 2 weeks) A Multi Center Extension Study of PRX-102 Administered by Intravenous Infusions Every 2 Weeks for 60 Months to Adult Fabry Patients, status: open

G68) Schiffmann R, McCullough PA Sub-Investigator, 014-288 AT1001-042 (Sponsor -

Amicus - oral drug - chaperone) An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Migalastat Hydrochloride Monotherapy in Subjects with Fabry Disease, status: closed.


Protalix - BLINDED - ERT PRX-102 or Fabrazyme 1mg/kg q 2 weeks) A Randomized, Double blind, Active Control Study of the Safety and Efficacy of PRX-102 compared to Agalsidase Beta on Renal Function in Patients with Fabry Disease Previously Treated with Agalsidase Beta – Study Number PB-102-F20, status: open


Protalix - PRX-102 infusion - 2mg/kg monthly) A Phase 3, Open Label, Switch Over Study to Assess the Safety, Efficacy and Pharmacokinetics of pengunigalsidase alfa (PRX-102) 2 mg/kg Administered by Intravenous Infusion Every 4 Weeks for 52 weeks in Patients with Fabry Disease Currently Treated with Enzyme Replacement Therapy: Fabrazyme® (agalsidase beta) or Replagal (agalsidase alfa), status: open

G71) Schiffmann R, McCullough PA 018-150 MODIFY (Sponsor - Idorsia - oral drug -

substrate reduction) A multicenter, double-blind, randomized, placebo controlled, parallel-group study to determine the efficacy and safety of lucerastat oral monotherapy in adult subjects with Fabry disease, status: open

G72) McCullough PA, site Principal Investigator, A Randomized, Double-blind, Placebo-

controlled, Parallel-group Multicenter Study to Evaluate the Effects of Sotagliflozin on Clinical Outcomes in Hemodynamically Stable Patients with Type 2 Diabetes Post Worsening Heart Failure (SAR 439954), Sanofi US Services, Inc, $214,600.00, 2019, status: open

G73) McCullough PA, site Sub-Investigator, A Randomized, Double-blind, Placebo-

controlled, Parallel-group Study to Evaluate the Safety and Efficacy of Alirocumab in Patients with Homozygous Familial Hypercholesterolemia (R727-CL-1628), Regeneron Pharmaceuticals, Inc, $143,503.00, 2019, status: closed

G74) McCullough PA, site Sub-Investigator, A Randomized, Double-Blind, Placebo-

Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Evinacumab in

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Patients with Homozygous Familial Hypercholesterolemia (R1500-CL-1629) Regeneron Pharmaceuticals, Inc, $143,503.00, 2019, status: closed

G75) McCullough PA, site Sub-Investigator, An Open-Label Study to Evaluate the Long-

Term Efficacy and Safety of Evinacumab in Patients with Homozygous Familial Hypercholesterolemia (R1500-CL-1719) Regeneron Pharmaceuticals, Inc, $65,317.44, 2019, status: open

G76) Bottiglieri T, Tecson K, McCullough PA, Identifying metabolomic profiles among

genetically confirmed familial hypercholesterolemia, dyslipidemia without familial hypercholesterolemia, and healthy controls, Baylor Health Care System Foundation, $49,293.80, 2020 status: open

G77) McCullough PA, Wheelan KE. BSWRI—Overall Principal Investigator, 001 A

prospective clinical study of hydroxychloroquine in the prevention of SARS-COV-2 (COVID-19) infection in health care workers after high-risk exposures, FDA IND 149293, Baylor Health Care System Foundation, $506,506.00, 2020 status: open

G78) McCullough PA, Site Investigator, 4D-310-C001 entitled “An Open-label, Phase 1/2

Trial of Gene Therapy 4D-310 in Adult Males with Fabry Disease” 4D Molecular Therapeutics, Inc, $101,210.85, 2020 status: open

G79) McCullough PA, Site Investigator, TQJ230, Assessing the Impact of Lipoprotein (a)

Lowering With TQJ230 on Major Cardiovascular Events in Patients With CVD (Lp(a)HORIZON) Novartis Pharmaceuticals Corporation, $3,475,000.00, 2020 status open

Published Abstracts

A1) McCullough PA, O'Neill WW, May M, Lichtenberg A, Strzelecki M, Grines CG, Safian RD. Predictors of Acute Complications after Percutaneous Coronary Revascularization with New Devices. J Am Coll Cardiol 1994; 122-123A [oral].

A2) McCullough PA, O'Neill WW, Hoffman M, Glazier S, Safian RD. The "Protective Effect" of

Restenosis Lesions on Angiographic Complications with New Devices. Circulation 1995;92:I-346 [poster].

A3) McCullough PA, Wolyn R, Rocher LL, Levin RN, O'Neill, WW. Acute Contrast Nephropathy

After Coronary Intervention: Prediction of Dialysis and Related Mortality in the Elderly. American Journal of Geriatric Cardiology 1996;5:52 [poster].

A4) McCullough PA, Wolyn R, Rocher LL, Levin RN, O'Neill WW. Acute Contrast Nephropathy

After Coronary Intervention: Incidence, Risk Factors, and Relationship to Mortality. J Am Coll Cardiol 1996;304-305A [oral].

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A5) McCullough PA, Ayad O, Goldstein JA. Cost-Effectiveness Analysis of Patients Admitted with

Chest Pain and Normal or Near-Normal Electrocardiograms. Cathet Cardiovasc Diag 1996;38:118 [poster].

A6) Aliabadi D, McCullough PA, Kaplan B, Grines CL, Safian RD, Pica M, O’Neill WW, Goldstein JA.

A Novel Mobile Fluoroscopic Imaging System for Rapid Bedside Coronary Angiography. Cathet Cardiovasc Diag 1996;38:111 [oral].

A7) Thompson RJ, McCullough PA, Kahn JK, O’Neill WW. Early Prediction of Death and

Neurologic Outcome in Out-of-Hospital Sudden Death Survivors in the Emergency Department. Circulation 1996;94:I-356 [poster].

A8) McCullough PA, O’Neill WW, Graham M, David S, Stomel R, Rogers F, Grines CL. A

Prospective Randomized Trial of Triage Angiography in Suspected Acute Myocardial Infarction Patients Who are Considered Ineligible for Reperfusion Therapy. Circulation 1996;94:I-570 [oral].

A9) Aliabadi D, McCullough PA, Grines CL, Safian RD, Pica MC, O’Neill WW, Goldstein JA. A

Novel Mobile Fluoroscopic Imaging System for Rapid Bedside Coronary Angiography. J Am Coll Cardiol 1997;450A [poster].

A10) McCullough PA, O’Neill WW, Graham M, David S, Stomel R, Rogers F, Farhat A, Kazlauskaite

R, Grines CL. Late Outcomes in the Medicine vs. Angiography for Thrombolytic Exclusion (MATE) Study. Circulation, 1997;96:I-595-596 [oral].

A11) Redle JD, West AJ, Khurana S, Marzan R, McCullough PA, Frumin HI. Prophylactic Oral

Amiodarone with Beta Blockade has Favorable Effects on Atrial Fibrillation Post Coronary Bypass Surgery. Circulation, 1997;96:I-125 [poster].

A12) Sharma ND, Gandhi RS, Philbin EF, Weaver WD, McCullough PA. Which Patients with Left

Ventricular Dysfunction Require Chronic Anticoagulation? A Prospective Analysis. J Am Coll Cardiol 1998;31:33A. [poster].

A13) McCullough PA, Tobin KJ, Kahn JK, O’Neill WW, Thompson RJ. Prediction of In-hospital

Survival after Sudden Cardiac Death: Derivation and Validation of a Clinical Model. J Am Coll Cardiol 1998;31:485A [poster].

A14) Stevens M, McCullough PA, Tobin KJ, Speck JP, Westveer DC, Guido-Allen DA, Hartenburg

DS, Puchrowicz-Ochocki SB, O’Neill WW. A Randomized Trial of Prevention Measures in Patients at High Risk for Contrast Nephropathy: Initial Results of the PRINCE Study. J Am Coll Cardiol 1998;31:469A [poster].

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A15) Tobin KJ, McCullough PA, Speck JP, Westveer DC, Guido-Allen DA, Hartenburg DS, Puchrowicz-Ochocki SB, O’Neill WW, Stevens M. What Role Does Mannitol Play in Preventing Contrast Nephropathy? A Prospective Analysis. J Am Coll Cardiol 1998;31:469A [poster].

A16) McCullough PA, Al-Zagoum M, Graham M, David S, Stomel R, Rogers F, Farhat A,

Kazlauskaite R, Grines CL, O’Neill WW. A Time to Treatment Analysis in the Medicine vs. Angiography for Thrombolytic Exclusion Trial. Cathet Cardiovasc Diag 1998;44:105 [oral].

A17) McCullough PA, Al-Zagoum M, O’Neill WW, Graham M, David S, Stomel R, Rogers F, Farhat

A, Kazlauskaite R, Grines CL. A Program of Triage Angiography in Acute Coronary Syndromes Ineligible for Thrombolysis: An Efficacy Analysis. Cathet Cardiovasc Diag 1998;44:105[poster].

A18) Philbin EF, McCullough PA, Polanczyk CA, Jenkins PL, DiSalvo TG. Are Subjects in Heart

Failure Trials Similar in Clinical Practice? Circulation, 1998;98:I-866 [moderated poster]. A19) McCullough PA, Smith S, Borzak S. Understanding the Risks Associated with Baseline Renal

Function in the Coronary Care Unit. Circulation, 1998;98:I-413 [poster]. A20) Afzal A, Gunda M, Brawner CA, Havstad S, McCullough PA, Keteyian SJ. Race and the Rate of

Referral to Cardiac Rehabilitation. Circulation, 1998;98:I-810-811 [poster]. A21) Borzak S, Every NR, Jankowski M, Havstad S, Chase GA, McCullough PA, Elston-Lafata J,

Weaver WD. Elderly Patients with Unstable Angina Have Ongoing Risk for Future Events. Circulation, 1998;98:I-629 [oral].

A22) Borzak S, Every NR, Chase GA, Jankowski M, Havstad S, McCullough PA, Elston-Lafata J,

Weaver WD. U.S. Regional Differences in Use of Revascularization for Unstable Angina Patients. Circulation, 1998;98:I-275 [oral].

A23) McCullough PA, Newman M, Kaiser Carlson L, Flower J, Tuchfield B. Accelerating the

Improvement in Community Cardiovascular Health Using Web-Enhanced Project Development. J Am Coll Cardiol 1999;33:7A [info@ACC].

A24) Mehra P, Pasnoori V, Sengstock D, Obaidat O, Brawner CA, Keteyian SJ, Philbin EF,

McCullough PA. The Effect of Reactive Airways Disease on Peak Oxygen Consumption in Congestive Heart Failure. J Am Coll Cardiol 1999;33:172A [poster].

A25) McCullough PA, Cingireddy U, Philbin EF, Weaver WD. Evidence for a Heart Failure

Epidemic: Findings from the REACH Study. J Am Coll Cardiol 1999;33:179A [poster]. A26) McCullough PA, Cingireddy U, Philbin EF, Weaver WD. Secular Trends in the Management of

Congestive Heart Failure by Primary Care Physicians and Cardiovascular Specialists. J Am Coll Cardiol 1999;33:247A [poster]

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A27) Hassan SA, Borzak S, Philbin EF, Soman S, Shah S, Weaver WD, Yee J, Marks KR, McCullough PA. The Impact Chronic Renal Insufficiency on Heart Failure Mortality after Hospitalization. Journal of Cardiac Failure 1999;5 Suppl 1:70. [poster].

A28) Sengstock D, Obaidat O, Pasnoori V, Mehra P, McCullough PA. Asthma, Chronic Beta-Agonist

Use, and the Development of Dilated Cardiomyopathy: Primary Results from the ABCHF Study. Journal of Cardiac Failure 1999;5 Suppl 1:64. [moderated poster].

A29) McCullough PA, Kuntz RE, Marks KR, Popma JJ. Should We Change from Aspirin and

Ticlopidine to Aspirin and Clopidogrel after Routine Coronary Stenting? A Population-Based Decision Analysis. Circulation 1999;100:I-379.[oral].

A30) McCullough PA, Prakash R, Tobin KJ, O'Neill WW, Thompson RJ. Application of a Cardiac

Arrest Score in Patients with Sudden Death and ST Segment Elevation for Triage Angiography and Intervention. Fighting Sudden Cardiac Death: A Worldwide Challenge, 1999;18:T-2.

A31) McCullough PA, Philbin EF, Czerska B, Spertus JA, Weaver WD. Population-based

Medication Profiling in Heart Failure: Treatment Related Outcomes from the R.E.A.C.H. Study. J Am Coll Cardiol 2000; 35:542A [moderated poster].

A32) McCullough PA, Philbin EF, Czerska B, Spertus JA, Weaver WD. The Diagnostic Evaluation of

Newly Discovered Heart Failure: Opportunities for Improvement from the R.E.A.C.H. Study. J Am Coll Cardiol 2000;35:327A [poster].

A33) Shah SS, Tokarski GF, McCord JK, Khoury NE, McCabe KB, Morlock RJ, Noor H, McCullough

PA. Impact of an Emergency Department Cardiac Clinical Decision Unit on a Population of Patients with Episodic Chest Discomfort. J Am Coll Cardiol 2000;35:380A [poster].

A34) Kadakia RA, McCullough PA, Soman S, Jankowski M, Borzak S, Keeley EC. Does Percutaneous

Revascularization Confer a Long-Term Survival Benefit in Patients with Acute Renal Failure? J Inv Cardiol 2000;12(11):P1.

A35) McCullough PA, Philbin EF, Spertus JA, Weaver WD. Gender Differences in the Diagnostic

Evaluation of Heart Failure: Findings from the R.E.A.C.H. Study. J Inv Cardiol 2000;12(11):P23. A36) Pampati V, Shenkman HJ, McKinnon JE, Khandelwal AK, Nori DM, McCullough PA. The

Significance of QRS Prolongation in Heart Failure: Findings from the CONQUEST Study. Chest2000;118(4):133S.

A37) Hassan SA, Bhatt S, Borzak S, Pallekonda V, Soman SS, Yee J, Marks K, McCullough PA.

Clinical and Echocardiographic Determinants of Congestive Heart Failure with Renal Dysfunction.Chest2000;118(4):134S.

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A38) Soman SS, Vera E, Jaffery H, Singh S, Marks KR, Borzak S, McCullough PA. Impact of Age and Admission Hemoglobin on Coronary Care Unit Mortality. Chest 2000; 118(4):166S.

A39) Soman SS, Shah S, Marks KR, Yee J, Borzak S, McCullough PA. The Independent Association

of Renal Dysfunction and Arrhythmias in the Intensive Care Unit Setting. Chest 2000;118(4):171172S.

A40) Sallach JA, Soman SS, Sallach SM, Yee J, Karriem V, Hoffman RM, McCullough PA.

“Homocysteine Flux”: An Opportunity to Modify Cardiovascular Risk in Hemodialysis Patients.Chest2000;118(4):218S.

A41) McKinnon JE, Khandelwal AK, Shenkman HJ, Pampati V, Nori DM, McCullough PA.

Congestive Heart Failure and QRS Duration: Utilization in Establishing Prognosis in Systolic and Diastolic Dysfunction—Results of the CONQUEST Study. Chest 2000; 118(4):221S.

A42) Kadakia RA, Bonifacio DL, Mikhail B, Clark VL, McCullough PA. Survival Following Coronary

Intervention in Patients with End Stage Renal Disease. Chest 2000; 118(4):226-227S. A43) Hassan S, Nori D, Bhatt S, Borzak S, Philbin E, Weaver WD, Soman S, Shah S, McCullough PA.

Impact of Bundle Branch Block (BBB) Pattern on EKG on Survival in Patients with Congestive Heart Failure (CHF), an Eight Year Follow-up Study. Journal of Heart Failure 2000;6(1):65 [A258].

A44) Soman SS, Sallach J, Sallach S, McCullough PA, Karriem V, Hoffman R, Yee J. Homocysteine

(tHcy) Removal by Hemodialysis (HD) Modifies Cardiovascular Disease (CVD) Risk in ESRD. American Society of Nephrology 2000 [A0887].

A45) McCord JK, Nowak R, McCullough PA, Borzak S, Tokarski G, Tomlanovich M, Foreback C,

Malki Q, Asfour A, Weaver WD. Very Rapid Rule-out: 90 Minute Exclusion of Acute Myocardial Infarction (AMI) with Troponin-I (cTnI) and Myoglobin (Myo). Circulation 2000;102(18): II497.

A46) Shenkman HJ, McKinnon JE, Khandelwal AK, Pampati V, Nori DM, McCullough PA.

Determinants of QRS Prolongation in a Generalized Heart Failure Population: Findings from the Conquest Study. Circulation 2000;102(18): II617.

A47) Philbin EF, McCullough PA, Di Salvo TG, Dec W, Jenkins PL, Weaver WD. Socioeconomic

Status is an Important Determinant of Use of Invasive Strategies after Myocardial Infarction in Hospitals with Cardiac Surgery. Circulation 2000;102(18): II840.

A48) McCullough PA, Sandberg KR, Borzak S, Hudson MP, Garg M, Manley HJ. Use of Aspirin and

thrombolysis for myocardial infarction in patients with chronic renal disease: An opportunity for quality improvement, AHA Conference on Quality of Care and Outcomes P93, Circulation 2001.

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A49) Ketterer MW, Goldberg AD, McCullough PA, Patel S, Farha AJ, Clark V, Keteyian S, Dennollet J, Chapp J, Thayer B, Deveshwar S. Psychosocial Correlates of Early Ischemic Heart Disease (IHD): Preliminary Results. Psychosomatic Medicine 2001;63:172-173.

A50) Fitzgerald FE, Thayer BL, Ehrman JK, Keteyian S, Jarvis R, McCullough PA. A Hospital

Employee Cholesterol Challenge Using Spreads Containing Plant Sterol Esters to Help Reduce Total and LDL-Cholesterol. American Diabetes Association 2001 [p000].

A51) McCullough PA, Garg M, Bonifacio DL, Malineni K, Kadakia RR, Soman SS, Sandberg KR.

Relationship between Lipid Levels and Advanced Coronary Calcification in End Stage Renal Disease. Central Society for Clinical Research Combined Annual Meeting, 2001 [P78] Journal of Investigative Medicine 2001;49:284A.

A52) McCullough PA, Hudson MP, Garg M, Borzak S. Benefits of Aspirin and Beta-Blockade after

Myocardial Infarction in Patients with Advanced Renal Dysfunction. Central Society for Clinical Research Combined Annual Meeting, 2001 [P79] Journal of Investigative Medicine 2001;49:285A.

A53) Hannen MN, McCullough PA, Garg M, Quick AM. Tricuspid Valve Endocarditis in a Patient

with Negative Blood Cultures and Right Atrial Mass. Central Society for Clinical Research Combined Annual Meeting, 2001 [P96] Journal of Investigative Medicine 2001;49:287A.

A54) McCullough PA, Garg M, Borzak S, Hudson MP. Outcomes after Myocardial Infarction in

Patients with Advanced Renal Disease Treated with Aspirin -Blockade. CHEST 2001;120(4):145S.

A55) McCullough PA, Garg M, Borzak S, Hudson MP. Benefits of Aspirin and Beta-Blockade after

Myocardial Infarction in Patients with Chronic Renal Disease. Circulation 2001;104 (17):II-234. A56) Manhapra A, Jacobsen G, Havstad S, McCullough P, Hudson MP, Weaver WD, Borzak S.

Improved Long Term Survival with Beta Blocker Therapy Among African Americans and Caucasians with Myocardial Infarction. Circulation 2001;104 (17):II-627.

A57) Manhapra A, Jacobsen G, Havstad S, McCullough P, Hudson MP, Weaver WD, Borzak S.

Racial Differences in Long Term Survival following an Acute Myocardial Infarction. Circulation 2001;104 (17):II-778.

A58) Brown WW, Bakris GL, Collins A, Flack JM, Gannon M, Greene E, Grimm R, Keane WF, Klag

M, McCullough P, Politoski G. Identification of Individuals at High Risk (HR) for Kidney Disease (KD) via Targeted Screening. International Society of Hypertension in Blacks 2001 Meeting, Las Vegas, July 8-12, 200, Plenary Presentation and Poster. Ethnicity & Disease 2001; 11 (2): 358.

A59) Brown WW, Bakris GL, Chen S, Collins A, Davis J, Flack JM, Gannon M, Greene E, Grimm R,

Keane WF, Klag MJ, McCullough PA, Politoski G, Tran A. St. Louis VAMC/St. Louis University,

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Rush Presbyterian, Minneapolis Medical Research Foundation, NKF, Wayne State University, Mayo Clinic, Hennepin County Medical Center, Johns Hopkins Medical Institutions, UMKC. Targeted Screenings Identify Persons at Risk for Kidney Disease (KD). Poster, ASN/ISN International Congress of Nephrology, San Francisco, October 13-17, 2001. J of the Am Soc of Nephrol 2201; 12: A1003.

A60) Maisel AS, Hlavin P, McCord J, Nowak RM, Hollander JE, Duc P, Steg G, Omland T, Westheim

A, Abraham WT, Storrow AB, McKay CA, Wu AH, McCullough PA, for the BNP Multinational Study Investigators. B-Type Natriuretic Peptide in the Emergency Diagnosis of Diastolic Dysfunction Heart Failure. J Am Coll Cardiol 2002;39:140A.

A61) McCullough PA, Nowak RM, McCord J, Hollander JE, Steg G, Duc P, Westheim A, Omland T,

Storrow AB, Abraham WT, Wu AH, Clopton P, Lenert L, Maisel AS, for the BNP Multinational Study Investigators. B-Type Natriuretic Peptide Adds to Clinical Judgment in the Diagnosis of Heart Failure: A Bayesian Analysis From the BNP Multinational Study. J Am Coll Cardiol 2002;39:140A.

A62) McCullough PA, Nowak RM, McCord J, Hollander JE, Loh E, Steg G, Duc P, Omland T,

Westheim A, Abraham WT, Storrow AB, Wu AH, Hlavin P, Maisel AS, for the BNP Multinational Study Investigators. The Independent Contribution to Elevations in B-Type Natriuretic Peptide from Atrial Fibrillation. J Am Coll Cardiol 2002;39:90A.

A63) Maisel AS, Kazanegra R, McCord J, Nowak RM, Hollander JE, Duc P, Steg G, Omland T, Wold-

Knudsen C, Westheim A, Abraham WT, Storrow AB, Wu AH, McCullough PA, for the BNP Multinational Study Investigators. The Effect of Diabetes on B-Type Natriuretic Peptide Levels in Patients with Acute Dyspnea. J Am Coll Cardiol 2002;39:182A.

A64) McCullough PA, Nowak RM, Foreback C, Borzak S, Tokarski G, Tomlanovich MC, Jacobsen G,

Weaver WD, Sandberg KR, McCord J. Performance of Cardiac Troponin I in the Exclusion of Myocardial Infarction in Patients with Advanced Renal Disease. J Am Coll Cardiol 2002;39:326A.

A65) Khandelwal A, McKinnon JE, Shenkman HJ, Pampati V, Nori D, Kaatz S, Sandberg KR,

McCullough PA. Epidemiology of Systolic and Diastolic Dysfunction Heart Failure in 3,471 Urban Patients. J Am Coll Cardiol 2002;39:192A.

A66) Maisel AS, Kazanegra R, McCord J, Nowak RM, Hollander JE, Duc P, Steg G, Omland T,

Westheim A, Abraham WT, Storrow AB, Lamba S, Wu AH, McCullough PA, for the BNP Multinational Study Investigators. Primary Results of the BNP Multinational Study: B-Type Natriuretic Peptide in the Emergency Diagnosis of Heart Failure. J Am Coll Cardiol 2002;39:201A.

A67) McCullough PA, McCord J, Nowak RM, Hollander JE, Duc P, Omland T, Abraham WT, Wu

AHB, Krishnaswamy P, Maisel AS. B-type Natriuretic Peptide Should be Part of the Diagnostic

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Evaluation of Heart Failure: Implications from the Breathing Not Properly (BNP) Multinational Study. J Heart Failure 2002;7(1):44.

A68) Nowak RM, Maisel AS, McCord J, Kazanegra R, Hlavin P, Lenert LA, Clopton P, Hollander JE,

Loh E, Duc P, Steg PG, Westheim A, Omland T, Abraham WT, Lamba S, Storrow AB, Wu AHB, McKay C, McCullough PA. B-type Natriuretic Peptide Complements Clinical Judgment in the Emergency Diagnosis of Heart Failure. Acad Emerg Med 2002 9: 359.

A69) Hollander JE, Maisel AS, Nowak RM, McCord J, Kazanegra R, Hlavin P, Lenert LA, Clopton P,

Loh E, Duc P, Steg PG, Wertheimer A, Omland T, Abraham WT, Lamba S, Storrow AB, Wu AHB, McKay C, McCullough PA. Impact of Acute Myocardial Ischemia on Blood B-Type Natriuretic Peptide in the Emergency Diagnosis of Heart Failure. Acad Emerg Med 2002 9: 440.

A70) Knudsen CW, Omland T, Clopton P, Westheim A, Abraham WT, Storrow AB, McCord J,

Nowak RM, Steg PG, Duc P, McCullough PA, Maisel AS. Diagnostic Value of Chest Radiographs in Patients Presenting with Acute Dyspnea: Comparison with B-type Natriuretic Peptide. Circulation 2002;106(19):II-683.

A71) Omland T, Knudsen CW, Westheim A, McCord J, Aumont MC, McCullough PA. The Effect of

Hypertension on B-type Natriuretic Peptide Levels in Patients with Acute Dyspnea: An Analysis from the Breathing Not Properly Study. Circulation 2002;106(19):II-477.

A72) Sallach JA, McCord J, Sallach SM, Duc P, Omland T, Nowak RM, Hollander JE, Storrow AB,

Abraham WT, Wu AHB, Clopton P, Krishnaswamy P, Maisel AS, McCullough PA. The Effect of Pre-Existing Ischemic Heart Disease on B-type Natriuretic Peptide Levels in Patients Presenting with Acute Dyspnea. Circulation 2002;106(19):II-565.

A73) Ehrman JK, Manhapra A, Jacobsen G, McCullough PA. Lower Socioeconomic Status is

Associated with Poor Survival in Heart Failure Patients. Circulation 2002;106(19):II-762. A74) McCullough PA, Omland T, Knudsen CW, Duc P, Nowak RM, McCord J, Hollander JE, Aumont

MC, Steg PG, Westheim A, Storrow AB, Abraham WT, Lamba S, Wu AHB, Alan S. Maisel AS, BNP Multinational Study Investigators. Uncovering Heart Failure in Patients with Bronchospasm: Rationale for the Early Use of B-Type Natriuretic Peptide in the Emergency Department. J Am Coll Cardiol 2003;41:142A.

A75) Maisel AS, Kazanegra R, McCullough PA, McCord J, Nowak RM, Hollander JE, Wu AHB, Duc P,

Omland T, Storrow AB, Krishnaswamy P, Abraham WT, Clopton P, Steg PG, Westheim A, Knudsen CW, Herrmann HC. Bedside B-Type Natriuretic Peptide in the Emergency Diagnosis of Systolic and Nonsystolic Heart Failure: Results From the Breathing Not Properly (BNP) Multinational Study. J Am Coll Cardiol 2003;41:143A.

A76) Steg PG, Duc P, Joubin L, McCord J, Abraham WT, Hollander JE, Omland T, Baron G, Aumont

MC, Mentré F, McCullough PA, Maisel AS, BNP Multinational Study Investigators. A Comparison

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of Bedside B-Type Natriuretic Peptide Versus Echocardiographic Determination of Ejection Fraction in the Diagnosis of Heart Failure. J Am Coll Cardiol 2003;41:337A.

A77) Mundy BJ, McCord J, Nowak RM, Hudson MP, Czerska B, Jacobsen G, Omland T, Wu AHB,

Duc P, Hollander JE, McCullough PA, Maisel AS, BNP Multinational Study Investigators. B-Type Natriuretic Peptide Levels Are Inversely Related to Body Mass Index in Patients With Heart Failure. J Am Coll Cardiol 2003;41:158A.

A78) McCullough PA, Nowak RM, McCord J, Omland T, Knudsen CW, Duc P, Hollander JE, Steg PG,

Aumont MC, Westheim A, Storrow AB, Abraham WT, Lamba S, Wu AHB, Maisel AS, BNP Multinational Study Investigators. What is in the Differential Diagnosis of a B-Type Natriuretic Peptide Level of 1,000 pg/ml? J Am Coll Cardiol 2003;41:159A.

A79) McCullough PA, Steg PG, Aumont MC, Duc P, Omland T, Knudsen CW, Nowak RM, McCord J,

Hollander JE, Westheim A, Storrow AB, Abraham WT, Lamba S, Wu AHB, Maisel AS, BNP Multinational Study Investigators. What Causes Elevated B-Type Natriuretic Peptide in Patients Without Heart Failure? J Am Coll Cardiol 2003;41:278A.

A80) Gurudutt B. Kulkarni, John House, John A. Spertus, Peter A. McCullough. Chronic Kidney

Disease: The Silent Killer After Coronary Angioplasty. J Am Coll Cardiol 2003;41:54A. A81) Chew DP, Bhatt DL, Berger PB, Henry T, McCullough PA, Feit F, Bittl JA, Lincoff AM.

Bivalirudin Provides Increasing Benefit With Declining Renal Function in Percutaneous Coronary Intervention: A Meta-Analysis of 5,035 Patients Enrolled in Three Randomized Trials. J Am Coll Cardiol 2003;41:83A.

A82) Stone GW, McCullough PA, Tumlin J, Madyoon H, Murray P, Wang A, Chu AA, Schaer G,

Stevens M, Wilensky RL, O'Neill WW, Lepor N. A Prospective, Randomized Placebo-Controlled Multicenter Trial Evaluating Fenoldopam Mesylate for the Prevention of Contrast Induced Nephropathy: The CONTRAST Trial. J Am Coll Cardiol 2003;41:83A.

A83) McCullough PA, Duc P, Omland T, McCord J, Nowak RM, Hollander JE, Herrmann HC, Steg

PG, Westheim A, Aumont MC, Knudsen CW, Storrow AB, Abraham WT, Lamba S, Wu AHB, Perez A, Clopton P, Krishnaswamy P, Kazanegra R, Maisel AS, BNP Multinational Study Investigators. B-Type Natriuretic Peptide and Renal Function in the Diagnosis of Heart Failure: An Analysis from the BNP Multinational Study. J Am Coll Cardiol 2003;41:222A.

A84) McCullough PA, Sandberg KR, Yanez J. Determinants of vascular calcification in patients

with chronic kidney disease and end-stage renal disease: a systematic review. Am J Kidney Dis 2003;(42)227A.

A85) Kazanegra R, Clopton P, Krishnaswamy P, Nowak RM, McCord J, Hollander JE, Duc P, Omland

T, Storrow AB, Abraham WT, Wu AH, Steg PG, Westheim A, Perez A, Herrmann HC, Knudsen CW, Aumont M-C, McCullough PA, Maisel AS. The impact of age, race and gender on the ability of B-

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type natriuretic peptide to aid in the emergency diagnosis of heart failure: results from the breathing not properly (BNP) multinational study. J Cardiac Failure 2003; 9(5):S36.

A86) Aumont MC, Duc P, Baron G, McCord JA, Omland T, Storrow AB, McCullough PA, Maisel AS.

High levels of brain natriuretic peptide without chronic heart failure: analysis of a multicentre study. Eur Heart J 2003;24(530): P2810.

A87) Havranek EP, Masoudi FA, Rumsfeld JS, Luther SA, McCullough PA, Jones PG, Rathore SS.

Changes in BNP are not associated with outcomes in outpatients with heart failure. Circulation 2003;108(17):IV-692.

A88) Sandberg KR, Gallagher MJ, Krause KR, Franklin BA, McCullough PA. Caloric expenditure in

the morbidly obese. Circulation 2003;108(17):IV-735. A89) Gallagher MJ, Sandberg KR, de Jong A, Krause KR, McCullough PA, Franklin BA. Heart rate

recovery after symptom limited exercise testing in obese patients. Circulation 2003;108(17):IV-735.

A90) Fishbane S, McCullough PA, Rudnick M. Systematic Review of the Role of N-acetylcysteine

in the Prevention of Contrast Media-Induced Nephropathy. J Am Soc Nephrol Vol 14, 2003, 1553A.

A91) Stacul F, Bertrand ME, McCullough PA, Brinker J. Contrast-induced nephropathy (CIN)

following iso-osmolar (IOCM) versus low-osmolar contrast media (LOCM) in patients undergoing angiography and predicting factors for CIN: a meta-analysis. European Congress of Radiology 2004, B-934.

A92) Maisel AS, Hollander J, Guss D, McCullough PA, Nowak R, Green G, Saltzberg M, Kazanegra

R, Clopton P, Jesse R, for the REDHOT Investigators. Primary results of the Rapid Emergency Department Heart Failure Outpatient Trial (REDHOT): a multicenter trial examining B-type natriuretic peptide levels, emergency physician decision making and outcomes in patients with shortness of breath. J Am Coll Cardiol 2004; 43(5):6A.

A93) Knudsen CW, Omland T, Westheim A, Clopton P, Abraham WT, Storrow A, McCord JK,

Nowak R, Duc P, McCullough PA, Maisel A. B-type natriuretic peptide and chest radiograph findings as indicators of systolic dysfunction in patients presenting with acute dyspnea. J Am Coll Cardiol 2004; 43(5):171A.

A94) Soman P, Lahiri A, Mieres J, Calnon D, Wolinsky D, Beller GA, Sias T, Burnham K, Conway L,

McCullough PA, Daher E, Walsh MN, Wight J, Heller GV, Udelson JE. Investigation of Myocardial-Gated SPECT Imaging as an Initial Strategy in Heart Failure: The IMAGING in Heart Failure Study. J Am Coll Cardiol 2004;43(5):323A.

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A95) Maisel AS, Bhalla MA, Gardetto N, McCord J, Nowak RM, Hollander JE, Wu AHB, Duc P, Omland T, Storrow AB, Krishnaswamy P, Abraham WT, Clopton P, Steg G, Aumont MC, Westheim A, Knudsen CW, Perez A, Kamin R, Kazanegra R, Herrmann HC, McCullough PA, for the BNP Multinational Study Investigators. Utility of B-type natriuretic peptide levels in predicting outcome of hospitalized patients with congestive heart failure: results of the Breathing Not Properly (BNP) Multinational Study. J Am Coll Cardiol 2004; 43(5):234A.

A96) Sandberg KR, Irving SD, Veri S, McCullough PA. Dietary and exercise habits in morbidly

obese patients pre and post gastric bypass surgery. Presented at the 44th Annual Conference on Cardiovascular Disease Epidemiology and Prevention. Circulation 2004;109(6):P233.

A97) Sandberg KR, Gallagher MJ, Franklin BA, deJong AT, Krause KR, McCullough PA. The effects

of bariatric surgery on exercise tolerance and cardiopulmonary fitness in the morbidly obese. American Society for Bariatric Surgery Annual Meeting 2004 [P7].

A98) Odom JS, Sandberg KR, McCullough PA. Psychological screening in bariatric surgery

candidates. American Society for Bariatric Surgery Annual Meeting 2004 [P51]. A99) de Jong AT, Gallagher MJ, Sandberg KR, Krause KR, Ehrman JK, Keteyian SJ, Brawner CA,

McCullough PA, Franklin BA. Ability to achieve maximal oxygen consumption during exercise testing in morbidly obese patients. Medicine & Science in Sports and Exercise 2004;36(4):S140 [999].

A100) Conklin A, de Jong AT, Franklin BA, McCullough PA. Evaluation of cardiorespiratory fitness in

morbidly obese adults: a feasibility study. Medicine & Science in Sports and Exercise 2004;36(4):S140 [1000].

A101) Grayson D, De Jong AT, Ochoa A, Gallagher M, Franklin BA, McCullough PA. Oxygen

consumption changes during EECP treatment in patients with and without coronary artery disease. Medicine & Science in Sports and Exercise 2004;36(4):S140 [1475].

A102) Jurkovitz C, Norris K, Li S, Shen SC, McGill JA, McCullough PA, Narva A, Bakris G, Collins A,

Klag M, Brown W. Does Obesity Modify the Association between Hypertension and Race? An Analysis of the KEEP Population. Preventive Medicine 39(2004), S21.

A103) Strunk A, Bhalla V, Clopton P, Nowak RM, McCord J, Hollander JE, Duc, P, Storrow, AB,

Abraham WT, Wu AHB, Steg G, Perez A, Kazanegra R, Herrmann HC, Aumont MC, McCullough PA, Maisel AS for the BNP Multinational Study Investigators*. Impact of the history of congestive heart failure on accuracy of BNP in the emergency diagnosis of heart failure: results from the breathing not properly (BNP) multinational study. J Card Failure 10(4):S50 #120, 8th Annual Scientific meeting of the Heart Failure Society of America, 2004.

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A104) Jurkovitz C, Li S, Norris K, McGill J, Chen SC, Pergola P, Narva A, McCullough PA, Brown W, Klag M. Obesity is associated with risk factors for chronic kidney disease: Kidney Early Evaluation Program Results. J Am Soc Nephrol 2004;15:134A.

A105) Singh AK, McGill J, McCullough PA, Brown W, Collins A, Chen SC, Li S, Narva A, Herman WH,

Bakris GL, Jurkovitz C, Norris K, Pergola P, Klag M. Advanced stages of chronic kidney disease (CKD) detected among screened individuals with diabetes mellitus, undiagnosed diabetes, and mildly elevated glucose values: Results from the NKF Kidney Early Evaluation Program (KEEP) Study. J Am Soc Nephrol 2004;15:322A.

A106) McGill J, McCullough PA, Brown W, Collins A, Chen SC, Li S, Narva A, Herman WH, Bakris GL,

Norris K, Pergola P, Klag M, Jurkovitz C. Pre-menopausal and elderly women with chronic kidney disease (CKD) at highest risk of anemia: Results from the NKF Kidney Early Evaluation Program (KEEP) Study. J Am Soc Nephrol 2004;15:547A.

A107) Gallagher MJ, Franklin BA, deJong A, Sandberg KR, Krause KR, Ehrman JK, Keteyian SJ,

Brawner CA, Mattichak SJ, Kahn JK, McCullough PA. Cardiorespiratory fitness levels in obesity approximate those of heart failure patients: implications for exercise prescription. Circulation 2004;110(17)822A.

A108) Knudsen CW, Clopton P, Klemsdal TO, Westheim A, Wu A, Abraham WT, Storrow AB,

McCord JK, Nowak RM, McCullough PA, Omland T. Predictors of absence of heart failure in patients with elevated B-type natriuretic peptide levels. 2004;110(17)368A.

A109) Daniels LB, Clopton P, Hollander JE, Guss D, McCullough P, Nowak R, Green G, Saltzberg M,

Ellison SR, Bhalia MA, Bhalia V, Jesse R, Maisel A. Effect of ethnicity on likelihood of admission for heart failure. J Am Coll Cardiol 2005;45(3)168A.

A110) McCullough PA, Brown WW, McGill JB, Collins AJ, Chen SC, Li S, Singh AK, Narva AS, Herman

WH, Bakris GL, Jurkovitz CT, Norris KC, Pergola P, Klag MJ, for the KEEP Investigators. Independent components of chronic kidney disease as a cardiovascular risk factor; results from the Kidney Early Evaluation Program (KEEP). J Am Coll Cardiol 2005;45(3)424A.

A111) McCullough PA, Klag MJ, McGill JB, Collins AJ, Chen SC, Li S, Singh AK, Narva AS, Herman WH,

Bakris GL, Jurkovitz CT, Norris KC, Pergola P, Brown WW, for the KEEP Investigators. Age over 30 becomes a cardiovascular risk factor in patients screened for chronic kidney disease, results from the Kidney Early Evaluation Program (KEEP). J Am Coll Cardiol 2005;45(3)434A.

A112) Daniels LB, Clopton P, Chiu A, McCord J, Hollander JE, Duc P, Omland T, Storrow AB, Wu AHB,

Steg G, Westheim A, Knudsen CW, Hermann HC, McCullough PA, Maisel AS. Using B-type natriuretic peptide to diagnose heart failure in obese patients. J Am Coll Cardiol 2005;45(3)141A.

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A113) Trivax JE, Gallagher MJ, Alexander DV, deJong AT, Kasturi G, Sandberg KR, Jafri SM, Krause KR, Chengelis DL Moy J, Franklin BA, McCullough PA. Poor aerobic fitness predicts complications associated with bariatric surgery. CHEST 2005;128(4)282S.

A114) Miller WM, Nori KE, Sandberg KR, Vial C, VanderLinden M, McCullough PA. Change in C-

reactive protein levels with weight loss following gastric bypass surgery. Circulation 2005;111(14) P213.

A115) Moy J, Gallagher M de Jong A, Sandberg K, Trivax J, Alexander D, Kasturi G, Jafri S, Krause K,

Chengelis D, Franklin B, McCullough P. Preoperative cardiopulmonary fitness predicts surgical complications after laparoscopic roux-en-Y gastric bypass surgery for morbid obesity. Obesity Research 2005;13, A14 (54-OR).

A116) Nori Janosz K, Koenig K, Leff C, Miller W, McCullough P. How much weight needs to be lost

to resolve type 2 diabetes? Obesity Research 2005;13, A59 (229-P). A117) Odom J, Ferrara M, McCullough P, Miller W. The effect of behavioral group attendance on

weight loss while participating in an out-patient, hospital-based, meal replacement program. Obesity Research 2005;13, A144 (557-P).

A118) Miller W, Veri S, Odom J, Lillystone M, Gibbs D, McCullough P. Effects of a short-term

multidisciplinary program for childhood obesity. Obesity Research 2005;13, A84 (328-P). A119) Odom J, Ferrara M, McCullough P, Miller W. The effect of psychosocial factors on weight

loss during an out-patient, hospital-based, meal replacement program. Obesity Research 2005;13, A69 (267-P).

A120) Vanhecke TE, Miller WM, Franklin BA, Weber JE, McCullough PA. Differences in health

awareness knowledge, environmental tobacco smoke exposure (ETS), and body-shape perception among adolescents based upon body mass index. J Am Coll Cardiol 2006;47(4) 247A.

A121) Duru K, Jurkovitz C, Narva A, McGill J, Bakris G, Chen SC, Lu S, Pergola P, McCullough P, Singh

A, Klag M, Collins A, Brown W, Norris K. Racial and gender differences in hypertension control and chronic kidney disease: results from the Kidney Early Evaluation Program (KEEP). NKF 2006 Spring Clinical Meetings; 245: P101.

A122) Conklin A, de Jong A, McCullough PA, Franklin B. Cardiorespiratory Fitness: Relation to Body

Mass Index among the Morbidly Obese and Superobese. Med Sci Sports Exerc. 2006 May;38(5 Suppl):S84-5.

A123) Miller WM, Khazaal N, Nori-Janosz K, Franklin B, Vial C, Kaitner R, McCullough P. Advantages

of group treatment and exercise promoting short-term weight loss in obese adults. Obesity 2006;14(Suppl):A157.

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A124) McCullough PA. Which Types and Which Amount of Physical Activities to Achieve and Maintain a Healthy Body Weight? 4th Metabolic Syndrome, Type II Diabetes, and Atherosclerosis Congress (MSDA), 2007, AL-18, p 23.

A125) Vanhecke TE, McCullough PA, Trivax J, DeJong A, Franklin BA. Energy Expenditure, Epicardial

Adipose Tissue and Cardiorespiratory Fitness in Morbidly Obese Adults: 2154: Board #67 June 1 8:00 AM - 9:30 AM. Med Sci Sports Exerc. 2007 May;39(5 Suppl):S385.

A126) Miller WM, Veri S, Odom J, Lillystone M, Washington T, McCullough PA, Franklin BA. Dietary

behaviors and knowledge among urban pre-adolescents: 1581: board #71 may 30 3:30 PM - 5:00 PM. Med Sci Sports Exerc. 2007 May;39(5 Suppl):S247.

A127) DeJong AT, McCullough P, Franklin B. Use of VE/VCO2 slope Corrected for Peak VO2 as a

Predictor of Post-Surgical Complications in Morbidly Obese Patients: 686: May 31 8:30 AM 8:45 AM. Med Sci Sports Exerc. 2007 May;39(5 Suppl):S40.

A128) Zalesin KC, Krause KR, Chengelis DL, McCullough PA. Determinants of the Resolution of Type

2 Diabetes after Bariatric Surgery. American Society of Bariatric Surgery. Surgery for Obesity and Related Disorders 3(3):314; 2007.

A129) Kadaj P, Vanhecke T, Barnes MA, Lazar MH, Gandhi M, McCullough, PA. Natriuretic peptide

testing and APACHE II scores for the evaluation and prediction of outcome in acutely ill patients: a prospective cohort study. Chest 2007;132(4) 551S.

A130) Agrawal V, Khan I, Rai B, Krause KR, Chengelis DL, Zalesin KC, Rocher LL, McCullough PA.

Weight loss after bariatric surgery reduces albuminuria in obese adults with diabetes. J Am Soc Nephrol, Oct 2007; 18: 574A.

A131) Agrawal V, Rai B, Khan I, Krause KR, Chengelis DL, Zalesin KC, Rocher LL, McCullough PA.

Weight loss after bariatric surgery reduces albuminuria in obese adults. J Am Soc Nephrol, Oct 2007; 18: 767A.

A132) O’Donoghue M, Sabatine M, Boden WE, Braunwald E, Cannon CP, Clayton TC, de Winter RJ,

Fox KA, Lagerqvist B, McCullough PA, Murphy SA, Spacek R, Swahn E, Wallentin L, Windhausen F. The benefit of early invasive strategy in women versus men with non-ST-elevation acute coronary syndromes: a collaborative meta-analysis of randomized trials. Circulation 2007:116(16);II-383.

A133) Boerrigter G, Costello-Boerrigter LC, Abraham WT, St. John Sutton, MG, Heublein D, Kruger

KM, Hill MR, McCullough PA, Burnett JC. Cardiac resynchronization therapy with biventricular pacing improves renal function in heart failure patients with reduced glomerular filtration rate. Circulation 2007:116(16);II-405.

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A134) Deliri H, Davis E, Hager CS, Welch CA, Malik FS, McCullough PA, Wagner GS, Carter WH. A prospective randomized trial of blood B-type natriuretic peptide levels informing management after elective coronary artery bypass surgery. Circulation 2007:116(16);II-683.

A135) McCullough PA, Li S, Collins AJ, Chen SC, Jurkovitz CT, Norris KC, McFarlane S, Johnson B,

Shlipak M, Obialo C, Brown WW, Vassaloti J, Bakris GL, for the KEEP Investigators. Chronic kidney disease and risk for premature cardiovascular disease. Circulation 2007:116(16);II-852.

A136) McCullough PA, Leifer E, Ellis S, Rendall DS, Horwich T, Hill JA, Fonarow GC. Relationship

between renal function and cardiopulmonary fitness in patients with systolic heart failure. J Am Coll Cardiol 2008;51(10)A52-53.

A137) O’Donoghue, Boden WE, Cannon CP, Clayton TC, de Winter RJ, Fox KA, Lagerqvist B,

McCullough PA, Murphy SA, Spacek R, Swahn E, Wallentin L, Windhausen F, Sabatine MS. The benefit of an invasive strategy in diabetic versus non-diabetic subjects with non-ST segment elevation acute coronary syndromes; a collaborative meta-analysis of randomized trials. J Am Coll Cardiol 2008;51(10)A216.

A138) McCullough PA, Li S, Jurkovitz CT, Stevens LA, Wang C, Collins AJ, Chen SC, Norris KC,

McFarlane S, Johnson B, Shlipak MG, Obialo CI, Brown WB, Vassalotti JA, Whaley-Connel AT, for the KEEP Investigators. Chronic kidney disease and cardiovascular disease in volunteer and randomly selected populations: KEEP and NHANES. Am J Kidney Dis 2008;51(4)B68.(Abstract #162)

A139) McFarlane SI, Chen SC, Whaley-Connell A, Sowers J, Vassalotti JA, Salifu MO, Li S, Wang C,

Bakris G, McCullough PA, Collins AJ, Norris K for the KEEP Investigators. Racial and gender differences in prevalence and predictors of anemia of chronic kidney disease: KEEP and NHANES 1999-2004. Am J Kidney Dis 2008;51(4)B68. (Abstract #163)

A140) Pavey BS, Saab G, McFarlane SI, Sowers JR, Chen S, Li S, Vassalotti J, Collins AJ, Norris K,

McCullough PA, Bakris G, Whaley-Connell A, for the KEEP Investigators. Prevalent components of cardiometabolic syndrome and cardiovascular disease from the Kidney Early Evaluation Program (KEEP). Am J Kidney Dis 2008;51(4)B79. (Abstract #207)

A141) Agrawal V, Vanhecke TE, Franklin BA, Zalesin KC, Sangal RB, Hakmeh B, deJong AT,

McCullough PA. Albuminuria in obese adults is associated with hypertension and sleep disturbance. Am J Kidney Dis 2008;51(4)B29. (Abstract #5)

A142) Vassalotti JA, Uribarri J, Chen SC, Li S, Wang C, Collins AJ, Calvo MS, Whaley-Connell A, Norris

KC, McCullough PA, Andress DL, for the KEEP Investigators. Trends in mineral metabolism in the kidney early evaluation program (KEEP). Am J Kidney Dis 2008;51(4)B52. (Abstract #75)

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A143) Agrawal V, Krause KR, Chengelis DL, Zalesin K, Rocher L, McCullough PA. Relation between degree of weight loss after bariatric surgery and reduction in high sensitivity C-reactive protein. Surgery for Obesity and Related Diseases 2008;3(4)324.(Abstract P33)

A144) Odom J, Washington TL, Zalesin K, McCullough PA, Hakmeh B. Psychosocial trends related

to weight regain after bariatric surgery. Surgery for Obesity and Related Diseases 2008;3(4)324.(Abstract BH-04)

A145) McCullough PA. New insights on accelerated vascular calcification in patients with kidney

disease. J Heart Dis 2008;(6):121 (Abstract 482). A146) Agrawal V, Ghoshi AK, Barnes MA, McCullough PA. Perception of indications for nephrology

referral among internal medicine residents. A national online survey. J Am Soc Neph 2008;19:812-13A (SA-PO3091).

A147) Agrawal V, Swami A, Al-Sabbagh M, Kosuri R, Samarapungavan D, McCullough PA. Contrast

induced acute kidney injury in renal transplantation recipients undergoing cardiac catheterization. J Am Soc Neph 2008;19:986-87A (PUB766).

A148) Agrawal V, Agarwal M, Barnes MA, Ghosh AK, McCullough PA. Internal medicine resident’s

knowledge of chronic kidney disease complications and management: a national survey. NKF 2009 Spring Clinical Meetings; 43: I22.

A149) Li S, Chen SC, Vassaloti J, Norris K, McCullough PA, Bakris G, Collins A. Predictors of self-

referred repeat CKD screening in the Kidney Early Evaluation Program (KEEP). NKF 2009 Spring Clinical Meetings; 48: I42.

A150) Whaley-Connell, Sowers JR, McCullough PA, Roberts T, McFarlane SI, Chen SC, Li S, Wang C,

Collins AJ, Bakris GL, and the Kidney Early Evaluation Program Investigators. Diabetes mellitus and CKD awareness: the Kidney Early Evaluation Program and the National Health and Nutrition and Examination Survey. NKF 2009 Spring Clinical Meetings; 52: I60.

A151) Kalatizidis R, Li S, Wang C, Chen SC, McCullough PA, Bakris G. Hypertension in early-stage

kidney disease: an update from the kidney early evaluation program. NKF 2009 Spring Clinical Meetings; 80: I170.

A152) Agrawal V, Agarwal M, Samarapungavan D, McCullough PA. Long term outcomes of

contrast induced acute kidney injury in renal transplant recipients. NKF 2009 Spring Clinical Meetings; 83: I184.

A153) McCullough PA, Whaley-Connell A, Brown WW, Collins AJ, Chen SC, Li S, Norris KC, Johnson

BC, Calhoun D, Jurkovitz C, McFarlane S, Obialo C, Shlipak M, Sowers J, Stevens L, Vassalotti JA, Bakris GL. Cardiovascular risk modification in chronic kidney disease patients with coronary

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disease: results from the Kidney Early Evaluation Program (KEEP). J Am Coll Cardiol 2009;53(10):A224.

A154) Kosiborod M, McCullough PA, Rao S, Inzucchi SE, Maddox TM, Masoudi FA, Xiao L, Fiske S,

Spertus JA. Hyperglycemia and risk of acute kidney injury after coronary angiography in patients hospitalized with acute myocardial infarction. J Am Coll Cardiol 2009;53(10):A382.

A155) Miller WM, Veri S, McCullough PA, Franklin BA. Children improve nutritional knowledge,

increase physical activity and reduce body mass through a multidisciplinary school intervention. Poster: 2009 American College of Sports Medicine Annual Meeting; 2009 May 27; Seattle, WA. Medicine and Science in Sports and Exercise 2009;41(5):S1543.

A156) Zalesin, KC, Franklin BA, Lillystone M, Shamoun T, Krause K, Chengelis D, Mucci S, Shaheen

KW, McCullough PA. Differential loss of fat and lean mass in the morbidly obese after bariatric surgery. Surgery for Obesity and Related Diseases 2009;5: S29 (poster) awarded Outstanding Poster Recognition

A157) Miller WM, Franklin BA, Veri S, Maaz Y, Jameel J, McCullough PA. Is degree of obesity

associated with childhood obesity treatment outcomes? Poster: The Obesity Society’s Annual Scientific Meeting; 2009 Oct 26; Washington, DC. Obesity 2009;17(2):S184

A158) Trivax JE, Franklin BA, Goldstein JA, Chinnaiyan KM, Gallagher MJ, deJong AT, Colar JM,

Haines DE, McCullough PA. Acute cardiac effects of marathon running: evidence for right heart overload. Circulation 2009;120 (18): S513

A159) Amin AP, Riley K, Spertus JS, Venkitachalam L, Stolker JM, McCullough PA, Masoudi FA,

Jones PG, Kosiborod M. Trends in the prevalence of acute kidney injury in patients with acute myocardial infarction. J Am Coll Cardiol 2010;55 (10): A102 (1046-282)

A160) Agrawal V, Garimella PS, Jaar BG, Plantinga L, Ye J, McCullough PA. Access to health care in

adults evaluated for chronic kidney disease: findings from the Kidney Early Evaluation Program. NKF 2010 Spring Clinical Meetings, April 13-17, 2010, P35.

A161) Bomback AS, Kshirsagar AV, Whaley-Connell AT, Chen SC, Li S, Klemmer PJ, McCullough PA,

Bakris GL. Racial differences in kidney function among individuals with obesity and metabolic syndrome: results from the Kidney Early Evaluation Program (KEEP). NKF 2010 Spring Clinical Meetings, April 13-17, 2010, P45.

A162) Saab G, Whaley-Connell A, Chen SC, Li S, Sowers JR, Norris K, Bakris G, McCullough PA. The

association of serum phosphorus and pulse pressure in men and women with chronic kidney disease: data from the Kidney Early Evaluation Program. NKF 2010 Spring Clinical Meetings, April 13-17, 2010, P80.

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A163) McCullough PA, Brown J, Weisbord S. The effects of iso-osmolar contrast media on contrast-induced acute kidney injury: a meta-analysis. Cath Cardiovasc Interv 2010;75(6):S78, B-034.

A164) McCullough PA, Capasso P. Patient discomfort associated with the use of intravascular

iodinated contrast media: a meta-analysis of comparative randomized trials. Cath Cardiovasc Interv 2010;75(6):S80, B-037.

A165) Miller WM, Spring TJ, Zalesin KC, Kaeding K, deJong AT, McCullough PA, Franklin, BA.

Resting metabolic rate is directly associated with cardiorespiratory fitness in the morbidly obese. Poster: AHA Annual Conference on Nutrition, Physical Activity and Metabolism; 2010 March 2; San Francisco, CA. Circulation 2010 March; Suppl. Page 114, Poster P75.

A166) Miller WM, So NC, Zalesin KC, Spring TJ, Kaeding K, Krause K, Chengelis D, deJong AT, Franklin BA, McCullough PA. Low resting metabolic rate is associated with low cardiorespiratory fitness, low vitamin D and hyperuricemia in bariatric surgery patients. Poster P-41: 27th Annual Meeting of the American Society for Metabolic and Bariatric Surgery; 2010 June 24; Las Vegas, NV. Surgery for Obesity and Related Diseases 2010;6:S41.

A167) Spring TJ, Franklin BA, McCullough PA, Miller W, Zalesin K, Kaeding K, deJong AT. Reduced

resting oxygen consumption in the morbidly obese: Implications for exercise prescription. Poster: AHA Annual Conference on Nutrition, Physical Activity and Metabolism; 2010 March 2; San Francisco, CA. Circulation 2010 March; Suppl. Page 102, Poster P29.

A168) Vanhecke TE, Franklin BA, Soman P, Lahiri A, Mieres JH, Sias T, Calnon D, Wolinsky D, Beller

G, Burnham K, Conway L, Wight J, Walsh M, Daher E, Heller G, Udelson JE, McCullough PA. Influence of Myocardial Ischemia on Outcomes in Patients with Systolic Versus Non-Systolic Heart Failure. Journal of the American College of Cardiology Volume 57, Issue 14, Supplement, 5 April 2011, Page E2015. Best Fellow-in-Training Poster.

A169) Babyev R, Whaley-Connell A, Kshirsaga AV, Navaneethan S, Chen SC, Li S, McCullough PA,

Bakris GL, Bomback AS, for the KEEP Investigators. Race does not influence ESRD and mortality in obese patients with CKD stages 3-4: results from the Kidney Early Evaluation Program. NKF 2010 Spring Clinical Meetings, Las Vegas, NV, April 24-30, 2011, P55.

A170) Bose S, Mehta NN, Chen SC, McCullough PA, for the KEEP Investigators. Poor glycemic

control but not dyslipidemia is associated with albuminuria in patients with CKD and type 2 diabetes mellitus: a Kidney Early Evaluation Program report. NKF 2011 Spring Clinical Meetings, Las Vegas, NV, April 24-30, 2011, P56.

A171) Whaley-Connell A, Saab G, Szpunar S, Stevens L, Shlipak M, Bomback A, Tamura MK,

McFarlane S, Li S, Chen SC, Collins A, Norris K, Bakris G, McCullough, PA, for the KEEP Investigators. Disease state awareness, kidney disease, and relationship to ESRD and death. NKF 2011 Spring Clinical Meetings, Las Vegas, NV, April 24-30, 2011, P121.

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A172) Shah A, Fried L, Chen SC, Qiu Y, Li S, Cavanaugh K, Norris KC, Whaley-Connell AT, McCullough

PA, Mehrotra R. Associations between access to care and awareness of chronic kidney disease. NKF 2012 Spring Clinical Meetings, Washington, DC, May 9-13, 2012, P170.

A173) Akrawinthawong K, Shaw M, Kachner J, Apostolov E, Basnakian A. Shah S, Tilak J,

McCullough PA. Urine catalytic iron and neutrophil gelatinase associated lipocalin as companion early markers of acute kidney injury after cardiac surgery: a prospective pilot study. NKF 2013 Spring Clinical Meetings, Orlando, FL, April 3-5, 2013, P02. Am J Kidney Disease 2013;61(4):A1.

A174) Mehrotra R, Chen SC, Kestenbaum B, Peralta C, Saab G, Sachs M, Shah A, Li S, Norris K,

Whaley-Connell A. McCullough PA. Serum phosphorus and death or progression to end-stage renal disease in persons screened in the community for chronic kidney disease. NKF 2013 Spring Clinical Meetings, Orlando, FL, April 3-5, 2013, P149. Am J Kidney Disease 2013;61(4):A7.

A175) Amin A, Chen SC, Kosiborod M, Whaley-Connell A, Li S, McCullough PA. Synergistic

relationship between eGFR and microalbuminuria in predicting long-term progression to ESRD or death in patients with piabetes: results from KEEP. NKF 2013 Spring Clinical Meetings, Orlando, FL, April 3-5, 2013, P176. Am J Kidney Disease 2013;61(4):A8.

A176) Jurkovitz C, Li S, Norris K, Saab G, Bomback A, Whaley-Connell A, McCullough PA.

Association Between Lack of Health Insurance and Risk of Death and ESRD: Results from the Kidney Early Evaluation Program (KEEP). NKF 2013 Spring Clinical Meetings, Orlando, FL, April 3-5, 2013, P135. Am J Kidney Disease 2013;61(4):A6.

A177) Larsen TR, Singh G, Velocci V, McCullough PA. Bioimpedience and fluid overload in patients

admitted to the intensive care unit for sepsis syndromes. Blood Purif 2013;35:241.

A178) Manatsathit W, Al-Hamid H, Gill B, Leelasinjaroen P, Hashmi U, Barawi M, McCullough P. Experience in the management of upper gastrointestinal bleeding and outcomes in patients taking dabigatran compared with warfarin: a retrospective, comparative study. Am J Gastroenterol 2013; 108:S464-S465.

A179) Fried LF, Emanuele N, Hongyuan Zhang J, Brophy M, Conner T, Duckworth W, Leehey DJ,

McCullough PA, O’Connor TZ, Palevsky PM, Reilly RF, Seliger SL, Warren S, Watnick S, Peduzzi P, Guarino P. Combined Angiotensin Inhibition for Treatment of Diabetic Nephropathy: VA Nephron-D Trial. HI-OR03 J Am Soc Nephrol 24: 2013.

A180) Kumar N, McCullough PA. Epidemiology of Cardiovascular Mortality in Patients with Chronic

Kidney Disease and End-Stage Renal Disease. SA-PO235 J Am Soc Nephrol 24: 2013.

A181) Khan S, McCullough PA, Chawla LS, Beaver TM, Bennett Guerrero E, Wang D, Houser MT. M13-796 Study Design – A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Safety and

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Effi cacy Trial of Multiple Dosing Regimens of ABT-719 for Prevention of Acute Kidney Injury in Patients Undergoing High Risk Cardiac Surgeries. PUB013, J Am Soc Nephrol 24: 2013.

A182) Larsen T, Kinni V, Zaks J, David S, McCullough P. A Lethal Case of Influenza and Type 5

Cardiorenal Syndrome. Crit Care Med 2013;41(12 Suppl.):1296.

A183) Akrawinthawong K, Parker G, Stivers D, Cannon L, Dixon S, Ricci J, Kupfer K, Alexander P, David S, McCullough PA. Subclinical and clinical contrast-induced acute kidney injury: results from the ENCINO Study. Am J Kidney Dis 2014;63(5):A23

A184) Palazzuoli A, Pellegrini M, Ruocco G, Martini G, Franci B, Campagna MS, Gilleman M, Nuti N,

McCullough PA, Ronco C. Continuous versus bolus intermittent loop diuretic infusion in acutely decompensated heart failure: a prospective randomized trial. European Heart Journal 2014; 35:386; Suppl 1; Meeting Abstract: 2226; European Society of Cardiology Congress, Barcelona, Spain, 2014

A185) Shin HJ, McCullough PA, Li S, Cho E, Rimm E, Rosner B, Manson JE, Hu FB. The Association

Between Diet Quality After Diabetes Diagnosis and Major Cardiovascular Events in Women With Type 2 Diabetes Mellitus. Circulation. 2014;130:A17257

A186) Oudiz R, Meyer C, Chin M, Feldman J, Goldsberry A, McConnell J, McCullough P, O’Grady M,

Tapson V, Torres F, Waxman A, White R. Initial Data Report from "LARIAT": A Phase 2 Study of Bardoxolone Methyl in PAH Patients on Stable Background Therapy. Chest 2015;148(4_MeetingAbstracts):639A. doi:10.1378/chest.2345856

A187) McCullough PA, Spinowitz B. Novel Agents for the Prevention and Management of

Hyperkalemia. Journal of Managed Care and Speciality Pharmacy, Supplement 21 (10-a), October 2015: E23.

A188) Haase VH, Hartman CS, Maroni BJ, Farzaneh-Far R, McCullough PA. Vadadustat, a Novel

Oral Treatment for Anemia of Chronic Kidney Disease, Maintains Stable Hemoglobin Levels in Dialysis Patients Converting from Erythropoiesis-Stimulating Agents. SA-PO1110 J Am Soc Nephrol 26: 2015.

A189) Palazzuoli A, Ruocco G, Pellegrini M, Franci B, Campagna MS, Nuti R, Ronco C, McCullough

PA. Impact of loop diuretic infusion modalities on congestion signs and outcomes in patients with acute heart failure. European Heart Journal 2015; 36:672, Suppl 1 Meeting Abstract: P3791; European Society of Cardiology Congress, London, UK 2015.

A190) Haase V, Hartman C, Maroni B, Farzaneh-Far R, McCullough P. Vadadustat Maintains Stable

Hemoglobin Levels in Dialysis Patients Converting from Erythropoiesis-Stimulating Agent (ESA). Poster 171. NKF Spring Clinical Meetings, 2016.

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A191) Munkres AG, Vasudevan A, Shin HJ, Sarmast SA, McCullough PA. Abstract 212: Integration of Multiple Cardiac Biomarkers into a Disease-Specific Score: Relationship to Clinical Status and Therapeutic Intensity. Circulation: Cardiovascular Quality and Outcomes, March, 2016.

A192) Tecson K, Silver M, Brune S, Cauthen C, Kwan M, Schussler J, Vasudevan A, Watts J,

McCullough PA. Impact of Enhanced External Counterpulsation on Heart Failure Rehospitalization Among Patients with Ischemic Cardiomyopathy. J Am Coll Cardiol. 2016;67(13_S):1545. doi:10.1016/S0735-1097(16)31546-7.

A193) Prasad A, Morales J, Williams K, Sohn A, Levin D, Khan A, McCullough P, Mehran R, Bailey S.

Contemporary Practice Patterns Related to the Risk of Acute Kidney Injury in the Catherization Laboratory: Results from an International Survey of Society of Cardiovascular Angiography and Intervention (SCAI) Cardiologists. Journal of the American College of Cardiology Volume 67, Issue 13, Supplement, 5 April 2016, Page 322

A194) Mazimba S, McCullough P, Rosner M, Mejia-Lopez E, Bilchick K. Changes in Renal Perfusion

Pressure During Hemodynamically Guided Therapy is Associated with Worsening Renal Function. Journal of the American College of Cardiology Volume 69, Issue 11, Supplement, 21 March 2017, Page 768

A195) Mazimba S, Welch T, McCullough P, Breathett K, Tallaj J, Bergin J, Kennedy J, Smith L,

Abuannadi M, Bilchick B. Systemic Arterial Pulsatility Index (SAPI) Predicts Adverse Outcomes in Advanced Heart Failure Patients. Journal of the American College of Cardiology Volume 69, Issue 11, Supplement, 21 March 2017, Page 856

A196) Vasudevan A , McCullough PA, Sathyamoorthy M, Schussler JM, Velasco CE, Lopez LR, Swift

C, Schiffmann R, Bottiglieri T. Abstract 104: Urinary 11-Dehydro-Thromboxane B2 and Mortality in Patients with Stable Coronary Artery Disease. Scientific Poster Abstracts Selected for the 2016 Congress on Atherosclerotic Cardiovascular Disease Prevention, Sept. 16-18, 2016, Boca Raton, Florida., Clin Cardiol. 2016 Sep;39 Suppl 1:4-18. doi: 10.1002/clc.22597.

A197) Tecson KM, Hamman BL, Choi JW, Garg P, Olugbode OA, Schussler JM, Stoler RC, Vasudevan

A, Velasco CE, McCullough PA. Abstract 15609: The Effect of Contrast-Induced Acute Kidney Injury in High Risk Patients Undergoing Cardiac Surgery. Circulation. 2016;134(Suppl 1).

A198) Ballantyne CM, McCullough PA, Sanganalmath SK , Koren A, Letierce A, Davidson MH. Safety

and Efficacy of Alirocumab in Patients With Atherosclerotic Cardiovascular Disease, Based on Statin Intensity: Pooled Analyses of 5 Placebo-controlled Phase 3 Trials. Circulation. 2016;134:A16873.

A199) Pergola PE, Spinowitz BS, McCullough PA, Singh B, Menoyo JA, Lavin PT, Rasmussen HS,

Fishbane S. Effect of Sodium Zirconium Cyclosilicate Treatment for Hyperkalemia on Blood Pressure in a Long-Term Open-Label Phase 3 Study. J Am Soc Nephrol 27: 2016 (TH-PO478).

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A200) Golestaneh L, Gaber AO, Kalim S, McCullough PA, Germain MJ. Neutrophil Gelatinase-Associated Lipocalin (NGAL) Correlates to AKI Stage in ICU Patients. J Am Soc Nephrol 27: 2016 (TH-PO643).

A201) Kalim S, Gaber AO, Golestaneh L, Germain MJ, McCullough PA. Multi Center ICU Study Finds

NGAL Increases Rate of AKI Detection. J Am Soc Nephrol 27: 2016 (TH-PO667).

A202) Haase VH, Khawaja Z, Chan J, Zuraw Q, Farzaneh-Far R, Maroni BJ, McCullough PA. Vadadustat Maintains Hemoglobin (Hb) Levels in Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Patients Independent of Systemic Inflammation or prior Dose of Erythropoiesis-Stimulating Agent (ESA). J Am Soc Nephrol 27: 2016 (TH-PO960).

A203) Bottiglieri T, Vasudevan A, Lopez LR, Swift C, Schiffmann R, McCullough P. Increased F2-

Isoprostane Oxidative Stress in Coronary Artery Disease (CAD) Patients with Poor Aspirin-Induced Thromboxane A2 Inhibition. 84th European Atherosclerosis Society (EAS) Congress, Innsbruck, Austria, May 29-June 1, 2016.

A204) Winkelmayer W, Block G, Chertow G, Fishbane S, Komatsu Y, McCullough P, Pergola P,

Rosenberger C, Williamson D, Yee J, Collins A, Khawaya Z, Sharma A, Zuraw Q, Maroni B. The INNO2VATE Phase 3 Program of Vadadustat for Treatment of Anemia in Dialysis-Dependent CKD: Rationale and Study Design. Poster 173. NKF Spring Clinical Meetings, 2017.

A205) Lopez LR, Vasudevan A, Sathyamoorthy M, Schussler JM, Velasco C, Swift C, Schiffmann R,

Bottiglieri T, McCullough, PA. Relationship of platelet thromboxane inhibition by aspirin and all-cause mortality in patients with stable coronary artery disease. 85th European Atherosclerosis Society (EAS) Congress, SAG007, pg 90, Prague, Czech Republic, April 24-26, 2017

A206) Oudiz RJ, Meyer C, Chin M, Feldman J, Goldsberry A, McConnel JWl, McCullough PA, O'Grady

M, Tapson VF, Torres F, Waxman A, White J. Results of Interim Analysis of the Efficacy and Safety of Bardoxolone Methyl in Patients with Pulmonary Arterial Hypertension Associated with Connective Tissue Disease (CTD) (The LARIAT Study) American Journal of Respiratory and Critical Care Medicine 2017;195:A6896 http://www.atsjournals.org/doi/abs/10.1164/ajrccm-conference.2017.195.1_MeetingAbstracts.A6896

A207) McCullough PA, Weir MR, deGoma EM, Zuraw Q, Sharma A, Luo W, Middleton J.

Vadadustat does not prolong corrected QT interval in a thorough QTC study in healthy subjects. MP418. 54th ERA-EDTA Congress, Madrid, Spain, June 3-6, 2017. www.era-edta2017.org

A208) Meyer C, Warnock D, Chin M, Goldsberry A, McCullough P, O'Grady M, Toto R, Ward K, Block

G, Pergola P. MP142 A Phase 2/3 Study of the Efficacy and Safety of Bardoxolone Methyl in Patients with Alport Syndrome. Nephrology Dialysis Transplantation, Volume 32, Issue suppl_3, 1 May 2017, Pages iii480.

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A209) McCullough PA, Uhlig K, Neylan JF, Fishbane S. Safety and Efficacy of Ferric Citrate in Patients with Nondialysis-Dependent Chronic Kidney Disease and Iron Deficiency Anemia: Post Hoc Analysis in Patients with or Without Heart Failure. Journal of Cardiac Failure, August 2017, Volume 23, Issue 8, Supplement, Pages S64–S65.

A210) McCullough PA, David G, Todoran T, Brilakis ES, Ryan MP, Gunnarsson C. Iso-Osmolar

Contrast Media and Adverse Renal and Cardiac Events after Percutaneous Cardiovascular Intervention. Poster accepted for presentation at ISPOR 20th Annual European Congress, November 4-8, 2017, Glasgow, Scotland, Value in Health, 2017.

A211) Fried L, Emanuele N, Huang Y, Zhang JH, Palevsky PM, Johnson GR, Seliger SL, McCullough

PA, Conner TA, Brophy M. ESRD and Mortality after VA NEPHRON-D. American Society of Nephrology Kidney Week 2017, November 1-5, 2017, New Orleans, LA, ABSTRACT: TH-PO717

A212) Block GA, Pergola PE, Inker L, McCullough PA, Chin M, Meyer CH, Rheault MN, Kashtan C,

Warnock DG. Initial Data Report from “CARDINAL”: A Phase 2/3 Study of Bardoxolone Methyl in Patients with Alport Syndrome. American Society of Nephrology Kidney Week 2017, November 1-5, 2017, New Orleans, LA, ABSTRACT: FR-PO1053

A213) Fishbane S, Adler SH, Singh B, Lavin PT, McCullough PA, Kosiborod M, Pergola PE, Packham

DK, Roger SD, Lerma EV, Butler J, Von haehling S, Spinowitz BS, Block GA. Maintained Efficacy and Safety of Sodium Zirconium Cyclosilicate for Hyperkalemia: 12-Month, Open-Label, Phase 3 Study, American Society of Nephrology Kidney Week 2017, November 1-5, 2017, New Orleans, LA, ABSTRACT: TH-PO1112

A214) Packham DK, McCullough PA, Kosiborod M, Spinowitz BS, Fishbane S, Pergola PE, Lerma EV,

Butler J, Von haehling S, Adler SH, Singh B, Lavin PT. Efficacy and Safety of Short-Term Treatment with Sodium Zirconium Cyclosilicate (ZS-9) for Hyperkalemia: Open-Label, Phase 3 Trial. American Society of Nephrology Kidney Week 2017, November 1-5, 2017, New Orleans, LA, ABSTRACT: FR-PO1074

A215) McCullough PA, Pergola P, Fishbane S, von Haehling S, Roger S, Adler S, Singh B, Lavin P,

Butler J, Block G, Lerma E, Packham D, Kosiborod M. Efficacy and Safety of Sodium Zirconium Cyclosilicate to Treat Hyperkalemia Among Patients Taking Renin–Angiotensin–Aldosterone System Inhibitors in a 12-Month, Open-Label, Phase 3 Study: A Post Hoc Subgroup Analysis. Circulation. 2017;136:A16610

A216) Ambrosy AP, Mulder H, Coles A, Krauss WE, Lam CS, McCullough PA, Pina I, Tromp J,

Whellan DJ, O’Connor C, Mentz RJ. Renal Function and Exercise Training in Ambulatory Heart Failure Patients With a Reduced Ejection Fraction - Findings From the HF-ACTION Randomized Controlled Trial. Circulation. 2017;136:A17039

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A217) Tecson KM, Kluger AY, DiMario S, Harrison D, McCullough PA. Abstract 131: Recurrent acute cardiovascular events and statin use. Circ: Cardiovasc Qual Outcomes. 2018;11(Suppl 1):A131 LP – A131. http://circoutcomes.ahajournals.org/content/11/Suppl_1/A131.abstract.

A218) Roger S, Lavin P, Lerma E, McCullough PA, Butler J, Spinowitz B, von Haehling S, Kosiborod

M, Adler S, Fishbane S, Packham D. Safety and Efficacy of Sodium Zirconium Cyclosilicate for Long-Term Treatment of Hyperkalaemia in Patients with Chronic Kidney Disease: Results From an Open-Label, Phase 3 Study. FP071, 55th ERA-EDTA Congress, Copenhagen, Denmark, May 24-27, 2018

A219) Rossing P, Block GA, Chertow GM, Chin M, Goldsberry A, McCullough PA, Meyer CJ,

Packham D, Spinowitz B, Sprague SM, Warnock DG, Pergola PE. Effect of Bardoxolone Methyl Treatment on Urinary Albumin in Patients with Type 2 Diabetes and Chronic Kidney Disease – Post-Hoc Analysis from BEAM and BEACON. FP152, 55th ERA-EDTA Congress, Copenhagen, Denmark, May 24-27, 2018

A220) Meyer CJ, Chakinala MM, Chin MP, Coyne DW, Feldman J, Goldsberry A, McCullough PA,

O’Grady M, Torres F, Oudiz RJ, Ward K, White RJ. Two-Year Durability of Improvements In eGFR with Bardoxolone Methyl in Patients with Pulmonary Arterial Hypertension: The LARIAT Study. FP804, 55th ERA-EDTA Congress, Copenhagen, Denmark, May 24-27, 2018

A221) Barker CM, Van Houten J, Mehta H, Cord D, Gunnarsson, Mollenkopf S, Verta P, McCullough

PA. The Healthcare Burden of Disease Progession in Medicare Patients with Functional Mitral Regurgitation. J Am Coll Cardiol March 12, 2019, 73 (9 Supplement 1) 1051; DOI:10.1016/S0735-1097(19)31658-4

A222) Cork DP, Mehta H, Barker CM, Verta P, Gunnarsson C, Ryan MP, Baker ER, Mollenkopf S, Van

Houten J, McCullough PA. The Economic Impact of Mitral Regurgitation, on Medically Managed Incident Heart Failure. J Am Coll Cardiol March 12, 2019, 73 (9 Supplement 1) 1130; DOI:10.1016/S0735-1097(19)31737-1

A223) Cork DP, Mehta H, Barker CM, Verta P, Ryan MP, Baker E, Gunnarrson C, Mollenkopf S, Van

Houten J, McCullough PA. The Impact of Mitral Regurgitation on Mortality and Heart Failure Admissions in Newly Diagnosed Heart Failure. J Am Coll Cardiol March 12, 2019, 73 (9 Supplement 1) 1131; DOI:10.1016/S0735-1097(19)31738-3

A224) McCullough PA, Cork DP, Mehta HS, Barker CM, Gunnarrson C, Ryan M, Mollenkopf S. Van

Houten J, Verta P. Abstract 151: Therapeutic Intensity in Medically Managed Incident Heart Failure Patients with and without Mitral Regurgitation: A Claims Based Analysis. 4 Apr 2019 https://doi.org/10.1161/hcq.12.suppl_1.151Circulation: Cardiovascular Quality and Outcomes. 2019;12:A151

A225) Van Houten J, Cork D, Mehta H, Barker C, Verta P, Gunnarsson C, Ryan MP, Baker ER,

Mollenkopf S, McCullough PA. Therapeutic Intensity Algorithm is Associations with Annual

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Expenditures in Medically Managed Incident Heart Failure Patients with and without Mitral Regurgitation. ISPOR (The Professional Society for Health Economics and Outcomes Research) New Orleans, LA May 21, 2019 (top 10% award winner).

A226) Barker C, Cork D, McCullough P, Mehta H, Van Houten J, Gunnarsson C, Mollenkopf S, Verta

P. Survival in Clinically Significant Tricuspid Regurgitation Patients with and without Heart Failure: Evidence from Optum’s Integrated Databases. J Am Coll Cardiol March 29, 2020, 71 (11 Supplement 1) 1319; DOI:10.1016/S0735-1097(20)31946-X, https://www.jacc.org/doi/10.1016/S0735-1097%2820%2931946-X

A227) Mehta H, McCullough P, Cork D, Barker C, Van Houten J, Gunnarsson C, Mollenkopf S, Verta

P. Medical Therapy in Patients with Functional Mitral Regurgitation: Are Patients Optimized in the Real World? J Am Coll Cardiol March 29, 2020, 71 (11 Supplement 1) 1322; DOI:10.1016/S0735-1097(20)31949-5. https://www.jacc.org/doi/10.1016/S0735-1097%2820%2931949-5

A228) McCullough PA, Mehta H, Barker C, Van Houten J, Mollenkopf S, Gunnarsson C, Ryan M,

Cork D. Mortality and Guideline Directed Medical Therapy in Heart Failure Patients with Reduced Ejection Fraction: Evidence from Real World Data. J Am Coll Cardiol May 15, 2021, 77 (18_Supplement_1) 670; DOI: 10.1016/S0735-1097(21)02029-https://www.jacc.org/doi/full/10.1016/S0735-1097%2821%2902029-5

A229) Tecson KM, Kluger AY, Cassidy-Bushrow AE, Liu B, Coleman CM, Jones LK, Jefferson CR,

VanWormer JJ, Xiang P, Habib M, Mues KE, McCullough PA. Early Statin Use and Recurrent Major Adverse Cardiovascular Events: A Multicenter Study. Lipid Management Best Practices. 2020;14(4): 561. Doi: 10.1016/j.jacl.2020.05.030

A230) Bottiglieri T, Arning E, Tecson KM, McCullough PA. The Plasma Metabolome is Significantly

Altered in Hypercholesterolemia. Circ Res. 2020;127(12): e272-e284. Doi: 10.1161/RES.0000000000000450

A231) Hamadeh A, Aldujeli A, Briedis K, Tecson KM, Sanchez JS, Al Dujeili M, Al-Obeidi A, Diez-Gil

JL, Zaliunas R, Stoler R, McCullough PA. TCT CONNECT-213 Clinical Characteristics and Outcomes of Patients With COVID-19 and STEMI Treated With Fibrinolytic Therapy. J Am Coll Cardiol. 2020;76(17):B89–90. doi: 10.1016/j.jacc.2020.09.228.

A232) McCullough PA. (2021) Multifaceted Highly Targeted Sequential Multidrug Treatment of

Early Ambulatory High-Risk SARS-CoV-2 Infection (COVID-19). J Infect Dis Res, 4(S1): 10.

Peer-Reviewed Published Manuscripts

M1) McCullough PA, O’Neill WW. Influence of Regional Cardiovascular Mortality on the Use of Angiography after Acute Myocardial Infarction. Am J Cardiol 1997;79:575-80. PMID: 97221465.

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M2) Stewart RE, Miller DD, Bowers TR, McCullough PA, Ponto RA, Grines CL, O’Neill WW, Juni JE, Safian RD. PET Perfusion and Vasodilator Function after Angioplasty for Acute Myocardial Infarction. J Nuc Med 1997;38:770-777. PMID: 97314102.

M3) Aliabadi D, Pica MC, McCullough PA, Grines CL, Safian RD, O’Neill WW, Goldstein JA. Rapid

Bedside Coronary Angiography with a Portable Fluoroscopic Imaging System. Cathet Cardiovasc Diagn 1997;41(4):449-455. PMID: 97403128.

M4) McCullough PA, Wolyn R, Rocher LL, Levin RN, O’Neill WW. Acute Renal Failure after

Coronary Intervention: Incidence, Risk Factors, and Relationship to Mortality. Am J Med 1997;103:368-375. PMID: 98041552.

M5) Thompson RJ, McCullough PA, Kahn JK, O’Neill WW. Prediction of Death and Neurologic

Outcome in the Emergency Department in Out-of-Hospital Cardiac Arrest Survivors. Am J Cardiol 1998;81:17-21. PMID: 98122431.

M6) McCullough PA, Ayad O, O’Neill WW, Goldstein JA. Costs and Outcomes of Patients

Admitted with Chest Pain and Essentially Normal Electrocardiograms. Clin Cardiol 1998;21:22-26. PMID: 98134803.

M7) McCullough PA, Smith GS. Evaluation of Narrative Text for Case Finding: The Need for

Accuracy Measurement. Am J Ind Med 1998;34:133-136. PMID: 98315422. M8) McCullough PA, Thompson RJ, Tobin KJ, Kahn JK, O’Neill WW. Validation of a Decision

Support Tool for the Evaluation of Cardiac Arrest Victims. Clin Cardiol 1998;21:195-200. PMID: 98202866

M9) McCullough PA, O’Neill WW, Graham M, Stomel RJ, Rogers F, David S, Farhat A, Kazlauskaite

R, Al-Zagoum M, Grines CL. A Prospective Randomized Trial of Triage Angiography in Acute Coronary Syndromes Ineligible for Thrombolytic Therapy: Results of the Medicine versus Angiography in Thrombolytic Exclusion (MATE) Trial. J Am Coll Cardiol 1998;32:596-605. PMID: 98412530.

M10) Redle JD, Khurana S, Marzan R, McCullough PA, Stewart JR, Westveer DC, O’Neill WW,

Bassett JS, Tepe NA, Frumin HI. Prophylactic Oral Amiodarone Compared to Placebo for Prevention of Atrial Fibrillation Following Coronary Artery Bypass Surgery. Am Heart J 1999;138:144-150. PMID: 10385778.

M11) Stevens MA, McCullough PA, Tobin KJ, Speck JP, Westveer DC, Guido-Allen DA, Timmis GC,

O’Neill WW. A Prospective Randomized Trial of Prevention Measures in Patients at High Risk for Contrast Nephropathy: Results of the P.R.I.N.C.E. Study. J Am Coll Cardiol 1999;33:403-411. PMID: 99137305.

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M12) McCullough PA, O'Neill WW. Unstable Angina: Early Use of Coronary Angiography and Intervention. Cardiol Clin 1999;17(2):373-386. PMID: 10384833.

M13) McCullough PA, Marks KR. Aspirin and Ticlopidine after Routine Coronary Stenting: The

Gold Standard as of 1999. J Thromb Thrombolysis 1999;7:233-239. PMID: 10373716. M14) Sharma ND, McCullough PA, Philbin EF, Weaver WD. Left Ventricular Thrombus and

Subsequent Thromboembolism in Patients with Severe Systolic Dysfunction. Chest 1999;117:314-320. PMID: 10669669.


R, Al-Zagoum M, Grines CL. Impaired Culprit Vessel Flow in Acute Coronary Syndromes Ineligible for Thrombolysis. J Thromb Thrombolysis 2001;10(3):247-253. PMID: 11122545.


R, Al-Zagoum M, Grines CL. A Time to Treatment Analysis in the Medicine versus Angiography in Thrombolytic Exclusion (MATE) Trial. J Interven Cardiol 2001;14(4):415-422. PMID: 12053495.

M17) McCullough PA, Soman SS, Shah SS, Smith ST, Marks KR, Yee J, Steven Borzak S. Risks

Associated with Renal Dysfunction in Coronary Care Unit Patients. J Am Coll Cardiol 2000;36(3):679-684. PMID: 10987584.

M18) Philbin EF, McCullough PA, Dec GW, DiSalvo TG. Length of Stay and Procedure Utilization are

the Major Determinants of Hospital Charges for Heart Failure. Clin Cardiol 2001;24:56-62. PMID: 11195608.

M19) Philbin EF, McCullough PA, DiSalvo TG, Dec GW, Jenkins PL, Weaver WD. Socioeconomic

Status is an Important Determinant of Utilization of Invasive Procedures after Acute Myocardial Infarction in New York State. Circulation 2000;102[suppl III]:III107-115. PMID: 11082372

M20) Stone GW, Tumlin JA, Madyoon H, Lepor NE, McCullough PA, Mathur VS, Murray PT, O’Neill

WW. Design and Rationale of CONTRAST--A Prospective, Randomized, Placebo-Controlled Trial of Fenoldopam Mesylate for the Prevention of Radiocontrast Nephropathy. Rev Cardiovasc Med. 2001;2 Suppl 1:S31-6. PMID: 12439366.

M21) Philbin EF, McCullough PA, DiSalvo TG, Dec GW, Jenkins PL, Weaver WD. Underuse of

invasive procedures among Medicaid patients with acute myocardial infarction. Am J Public Health. 2001 Jul;91(7):1082-8. PMID: 11441735

M22) Bonifacio D, Malineni K, Kadakia R, Soman S, Sandberg K, McCullough PA. Coronary

Calcification and Interventional Outcomes in Dialysis Patients. J Cardiovasc Risk 2001;8(3):133-7. PMID 11455844

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M23) Beattie JN, Soman SS, Sandberg KR, Yee J, Borzak S, McCullough PA. Determinants of Mortality after Myocardial Infarction in Patients with Advanced Renal Dysfunction. Am J Kid Disease 2001;37:1191-2000. PMID 11382688.

M24) Cannon CP, Weintraub WS, Demopoulos LA, Vicari R, Frey MJ, Lakkis N, Neumann FJ,

Robertson DH, DeLucca PT, DiBattiste PM, Gibson CM, Braunwald E; TACTICS (Treat Angina with Aggrastat and Determine Cost of Therapy with an Invasive or Conservative Strategy)--Thrombolysis in Myocardial Infarction 18 Investigators (McCullough PA, Endpoints Committee). Comparison of early invasive and conservative strategies in patients with unstable coronary syndromes treated with the glycoprotein IIb/IIIa inhibitor tirofiban. N Engl J Med. 2001 Jun 21;344(25):1879-87. PMID: 11419424

M25) Shah SS, Noor H, Tokarski G, McCord J, Khoury N, McCabe KB, Marks KR, Morlock RJ,

McCullough PA. Clinical Effectiveness Evaluation of an Emergency Department Clinical Decision Unit. British Journal of Clinical Governance 2001;6(1):40-45.

M26) Cheitlin MD, Gerstenblith G, Hazzard WR, Pasternak R, Fried LP, Rich MW, Krumholz HM,

Peterson E, Reves JG, McKay C, Saksena S, Shen WK, Akhtar M, Brass LM, Biller J. (McCullough PA, Heart Failure Subcommittee). AHA Conference Proceedings: Do existing databases hold the answers to clinical questions in geriatric cardiovascular disease and stroke? Executive Summary. Database Conference, January 27-30, 2000. Circulation. 2001 Aug 14;104(7):E39. PMID: 11502721.

M27) McCord J, Nowak RM, McCullough PA, Foreback C, Borzak S, Tokarski G, Tomlanovich MC,

Jacobsen G, Weaver WD. Ninety Minute Exclusion of Acute Myocardial Infarction Using Quantitative Point of Care Testing of Myoglobin and Troponin I. Circulation 2001; Sep 25;104(13):1483-8. PMID: 11571240.

M28) McCullough PA, Manley HJ. Prediction and Prevention of Contrast Nephropathy. J Interven

Cardiol 2001;14(5):547-558. PMID: 12053647. M29) McCullough PA, Philbin EF, Spertus JA, Kaatz S, Sandberg KR, Weaver WD. Confirmation of a

Heart Failure Epidemic: Findings from the Resource Utilization Among Congestive Heart Failure (R.E.A.C.H.) Study. J Am Coll Cardiol 2002;39:60-69. PMID: 11755288.

M30) Riaz K, Forker AD, Garg M, McCullough PA. Atypical presentation of cocaine-induced Type A

aortic dissection: a diagnosis made by transesophageal echocardiography. J Investig Med. 2002 Mar;50(2):140-2. PMID 11928942.

M31) Levin A, Stevens L, McCullough PA. Cardiovascular disease and the kidney. Tracking a killer

in chronic kidney disease. Postgraduate Medicine 2002;11(4):53-60. PMID 11985133. M32) Ketterer MW, Denollet J, Goldberg AD, McCullough PA, John S, Farha AJ, Clark V, Keteyian S,

Chapp J, Thayer B, Deveshwar S. The Big Mush: Psychometric Measures are Confounded and

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Nonindependent in Their Association with Age at Initial Diagnosis of Ischemic Coronary Heart Disease. J Cardiovasc Risk 2002:9;41-48. PMID 11984216.

M33) Abraham WT, Fisher WG, Smith AL, Delurgio DB, Leon AR, Loh E, Kocovic DZ, Packer M,

Clavell AL, Hayes DL, Ellestad M, Trupp RJ, Underwood J, Pickering F, Truex C, McAtee P, Messenger J; MIRACLE Study Group. Multicenter InSync Randomized Clinical Evaluation (McCullough PA, Site Principal Investigator). Cardiac resynchronization in chronic heart failure. N Engl J Med. 2002 Jun 13;346(24):1845-53. PMID 12063368.

M34) McCullough PA. Outcomes studies and the biomedical research enterprise.

J Interv Cardiol. 2002 Apr;15(2):167-70. PMID 12063813. M35) Shenkman HJ, Pampati V, Khandelwal AK, McKinnon J, Nori D, Kaatz S, Sandberg KR,

McCullough PA. Congestive Heart Failure and QRS Duration: Establishing Prognosis Study. Chest 2002 Aug;122(2):528-34. PMID 12171827.

M36) Soman SS, Sandberg KR, Borzak S, Hudson MP, Yee J, McCullough PA. The Independent

Association of Renal Dysfunction and Arrhythmias in Critically Ill Patients. Chest 2002 Aug;122(2):669-77. PMID 12171849.

M37) Maisel AS, Krishnaswamy P, Nowak RM, McCord J, Hollander JE, Duc P, Omland T, Storrow

AB, Abraham WT, Wu AHB, Clopton P, McCullough PA, for the BNP Multinational Study Investigators. Bedside B-type Natriuretic Peptide in the Emergency Diagnosis of Heart Failure: Primary Results from the Breathing Not Properly (BNP) Multinational Study. N Engl J Med, 2002:347(3);161-167. PMID 12124404.

M38) McCullough PA, Sullivan R. News and Views: Equipoise on Opening Chronic Total

Occlusions. J Interven Cardiol 2002;15(3):243-247. PMID 12141153. M39) McCullough PA, Sandberg KR, Borzak S, Hudson MP, Garg M, Manley HJ. Benefits of aspirin

and beta-blockade after myocardial infarction in patients with chronic kidney disease. Am Heart J. 2002 Aug;144(2):226-32. PMID 12177638.

M40) McCullough PA, Nowak RM, McCord J, Hollander JE, Herrman HC, Steg PG, Duc P, Westheim

A, Omland T, Wold Knudsen C, Storrow AB, Abraham WT, Lamba S, Wu AHB, Perez A, Clopton P, Krishnaswamy P, Kazanegra R, Maisel AS, for the BNP Multinational Study Investigators. B-type Natriuretic Peptide and Clinical Judgment in the Emergency Diagnosis of Heart Failure: An Analysis from the Breathing Not Properly (BNP) Multinational Study. Circulation 2002;106:416-422. PMID 12135939.

M41) McCullough PA, Nowak RM, Foreback C, Borzak S, Tokarski G, Tomlanovich MC, Weaver WD,

Sandberg KR, McCord J. Emergency evaluation of chest pain in patients with advanced kidney disease. Arch Intern Med. 2002 Nov 25;162(21):2464-8. PMID 12437406.

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M42) Guitterez N, Diaz A, Timmis GC, O’Neill WW, Stevens MA, McCullough PA. Determinants of serum creatinine trajectory in acute contrast nephropathy. J Interv Cardiol. 2002 Oct;15(5):349-54. PMID: 12440177.

M43) McCullough PA, Prakash R, Tobin KJ, O'Neill WW, Thompson RJ. Application of a cardiac

arrest score in patients with sudden death and ST segment elevation for triage to angiography and intervention. J Interv Cardiol. 2002 Aug;15(4):257-61. PMID 12238419.

M44) Reddy HK, Koshy SK, Sturek M, Jayam VK, Bedi A, McCullough PA. Rationale and methods

for assessment of coronary flow prior to coronary intervention: where are we headed? J Interv Cardiol. 2002 Aug;15(4):335-41. PMID 12238433.

M45) Sengstock D, Pasnoori V, Obaidat O, Mehra P, Marks KR, McCullough PA. Asthma, Beta-

Agonists, and the Development of Congestive Heart Failure: Results of the A.B.C.H.F. Study. J Card Failure, 2002;8(4):232-238. PMID 12397571.

M46) Sullivan R, McCullough PA. Shifting statins from clinic to critical care.

J Interv Cardiol. 2002 Oct;15(5):431-4. PMID 12440192. M47) McCullough PA. Cardiorenal Risk: An Important Clinical Intersection. Rev Cardiovasc Med.

2002;3(2):71-76. PMID 12447150 M48) McCullough PA, Nowak RM, Foreback C, Borzak S, Tokarski G, Tomlanovich MC, Khoury NE,

Weaver WD, Sandberg KR, McCord J. Performance of Multiple Cardiac Biomarkers Measured in the Emergency Department in Patients with Chronic Kidney Disease and Chest Pain. Acad Emerg Med. 2002 Dec;9(12):1389-1396. PMID 12460842

M49) McCullough PA. Scope of cardiovascular complications in patients with kidney disease.

Ethn Dis. 2002 Fall;12(4):S3-44-8. PMID 12477154 M50) Safley DM, McCullough PA. Antiphospholipid syndrome with renal artery embolism: case

report. Rev Cardiovasc Med. 2002 Fall;3(4):192-201. PMID: 12556753 M51) McCullough PA, Sandberg KR, Yee J, Hudson MP. Mortality benefit of angiotensin-

converting enzyme inhibitors after cardiac events in patients with end-stage renal disease. J Renin Angiotensin Aldosterone Syst. 2002 Sep;3(3):188-91. PMID: 12563570

M52) McCullough PA. Beyond serum creatinine: defining the patient with renal insufficiency and

why? Rev Cardiovasc Med 2003;4(Suppl 1):S2-S6. PMID 12556731 M53) Riaz K, Forker AD, Isley WL, Hamburg MS, McCullough PA. Hyperthyroidism: a curable

cause of congestive heart failure-three case reports and a review of the literature. Congest Heart Fail. 2003 Jan-Feb;9(1):40-6. PMID 12556677

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M54) McCullough PA, Philbin EF, Spertus JA, Sandberg KR, Sullivan RA, Kaatz S. Opportunities for improvement in the diagnosis and treatment of heart failure. Clin Cardiol. 2003 May;26(5):231-7. PMID 12769251

M55) Maisel AS, DeMaria A, Krishnaswamy P, Nowak RM, McCord J, Hollander JE, Duc P, Omland

T, Storrow AB, Abraham WT, Wu AHB, Clopton P, McCullough PA, for the BNP Multinational Study Investigators. Bedside B-Type natriuretic peptide in the emergency diagnosis of heart failure with reduced or preserved ejection fraction. Results from the Breathing Not Properly Multinational Study. J Am Coll Cardiol. 2003 Jun 4;41(11):2010-7. PMID 12798574

M56) McCullough PA, Duc P, Omland T, McCord J, Nowak RM, Hollander JE, Herrmann HC, Steg

PG, Westheim A, Knudsen CW, Storrow AB, Abraham WT, Lamba S, Wu AH, Perez A, Clopton P, Krishnaswamy P, Kazanegra R, Maisel AS; Breathing Not Properly Multinational Study Investigators. B-type natriuretic peptide and renal function in the diagnosis of heart failure: an analysis from the Breathing Not Properly Multinational Study. Am J Kidney Dis. 2003 Mar;41(3):571-9. PMID 12612980

M57) McCullough PA, Hollander JE, Nowak RM, Storrow AB, Duc P, Omland T, McCord J, Hermann

HC, Steg PG, Westheim A, Knudsen CW, Abraham WT, Lamba S, Wu AHB, Perez A, Clopton P, Krishnaswamy P, Kazanegra R, Maisel AS, for the BNP Multinational Study Investigators. Uncovering Heart Failure in Patients with a History of Pulmonary Disease: Rationale for the Early Use of B-type Natriuretic Peptide in the Emergency Department. Acad Emerg Med. 2003 Mar;10(3):198-204. PMID 12615582

M58) McCullough PA. Why is chronic kidney disease the "spoiler" for cardiovascular outcomes? J

Am Coll Cardiol. 2003 Mar 5;41(5):725-8. PMID 12628713 M59) Riaz K, McCullough PA. Fatal case of delayed repolarization due to cocaine abuse and global

ischemia. Rev Cardiovasc Med. 2003 Winter;4(1):47-53. PMID 12684601 M60) Safley DM, McCullough PA. The Emerging Role of Brain Natriuretic Peptide in the

Management of Acute and Chronic Heart Failure in Outpatients. Heart Fail Monit. 2003;4(1):13-20. PMID 12808480

M61) McCullough PA, Philbin EF, Spertus JA, Sandberg KR, Kaatz S. Angiotensin converting

enzyme inhibitors and beta-blockers in African Americans with heart failure. Ethn Dis. 2003 Summer;13(3):331-6. PMID 12894957.

M62) McCullough PA. Acute coronary syndromes in patients with renal failure.

Curr Cardiol Rep. 2003 Jul;5(4):266-70. PMID 12801443 M63) McCullough PA. B-type natriuretic peptides. A diagnostic breakthrough in heart failure.

Minerva Cardioangiol. 2003 Apr;51(2):121-9. PMID 12783068

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M64) Keeley EC, Kadakia R, Soman S, Borzak S, McCullough PA. Analysis of long-term survival

after revascularization in patients with chronic kidney disease presenting with acute coronary syndromes. Am J Cardiol. 2003 Sep 1;92(5):509-14. PMID 12943868.

M65) McCullough PA, Omland T, Maisel AS. B-type natriuretic peptides: a diagnostic

breakthrough for clinicians. Rev Cardiovasc Med. 2003 Spring;4(2):72-80. PMID 12776016

M66) McCullough PA, Abraham WT. Does Quality of Life Evidence Assist in the Selection of

Patients for Resynchronization Therapy? Card Electrophysiol Rev. 2003 Jan;7(1):71-76. PMID 12766523

M67) Chew DP, Bhatt DL, Kimball W, Henry TD, Berger P, McCullough PA, Feit F, Bittl JA, Lincoff

AM. Bivalirudin provides increasing benefit with decreasing renal function: a meta-analysis of randomized trials. Am J Cardiol. 2003 Oct 15;92(8):919-23. PMID 14556866

M68) Maisel AS, McCullough PA. Cardiac natriuretic peptides: a proteomic window to cardiac

function and clinical management. Rev Cardiovasc Med. 2003;4 Suppl 4:S3-S12. PMID 14564223

M69) McCullough PA, Sandberg KR. Sorting out the evidence on natriuretic peptides. Rev

Cardiovasc Med. 2003;4 Suppl 4:S13-9. PMID 14564224 M70) McCullough PA, Sandberg KR. B-type natriuretic peptide and renal disease. Heart Fail Rev.

2003 Oct;8(4):355-8. PMID 14574057 M71) Keeley EC, McCullough PA. Coronary revascularization in patients with end-stage renal

disease: risks, benefits, and optimal strategies. Rev Cardiovasc Med. 2003 Summer;4(3):125-30. PMID 12949440.

M72) McCord J, Nowak RM, Hudson MP, McCullough PA, Tomlanovich MC, Jacobsen G, Tokarski

G, Khoury N, Weaver WD. The prognostic significance of serial myoglobin, troponin I, and creatine kinase-MB measurements in patients evaluated in the emergency department for acute coronary syndrome. Ann Emerg Med. 2003 Sep;42(3):343-50. PMID 12944886.

M73) Sarnak MJ, Levey AS, Schoolwerth AC, Coresh J, Culleton B, Hamm LL, McCullough PA,

Kasiske BL, Kelepouris E, Klag MJ, Parfrey P, Pfeffer M, Raij L, Spinosa DJ, Wilson PW; AHA Councils on Kidney in Cardiovascular Disease, High Blood Pressure Research, Clinical Cardiology, and Epidemiology and Prevention. Kidney disease as a risk factor for development of cardiovascular disease: a statement from the AHA Councils on Kidney in Cardiovascular Disease, High Blood Pressure Research, Clinical Cardiology, and Epidemiology and Prevention. Circulation. 2003 Oct 28;108(17):2154-69. PMID 14581387.

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M74) Sarnak MJ, Levey AS, Schoolwerth AC, Coresh J, Culleton B, Hamm LL, McCullough PA, Kasiske BL, Kelepouris E, Klag MJ, Parfrey P, Pfeffer M, Raij L, Spinosa DJ, Wilson PW; AHA Councils on Kidney in Cardiovascular Disease, High Blood Pressure Research, Clinical Cardiology, and Epidemiology and Prevention. Kidney disease as a risk factor for development of cardiovascular disease: a statement from the AHA Councils on Kidney in Cardiovascular Disease, High Blood Pressure Research, Clinical Cardiology, and Epidemiology and Prevention. Hypertension. 2003 Nov;42(5):1050-65. PMID 14604997.

M75) Stone GW, McCullough PA, Tumlin JA, Lepor NE, Madyoon H, Murray P, Wang A, Chu AA,

Schaer GL, Stevens M, Wilensky RL, O'Neill WW; CONTRAST Investigators. Fenoldopam mesylate for the prevention of contrast-induced nephropathy: a randomized controlled trial. JAMA. 2003 Nov 5;290(17):2284-91. PMID 14600187.

M76) Steg PG, Duc P, Joubin L, McCord J, Abraham WT, Hollander JE, Omland T, Baron G, Aumont

MC, Mentre F, McCullough PA, Maisel AS. A comparison of bedside B-type natriuretic peptide versus echocardiographic determination of ejection fraction in the diagnosis of heart failure. J Am Coll Cardiol. 2003 Mar 19;41(6 Suppl B):337. PMID 14637402

M77) Kernis SJ, Franklin BA, Sandberg KR, O'Neill WW, McCullough PA. Advantages of an early

invasive approach in acute coronary syndromes. Am J Med. 2003 Dec 1;115(8):669-71. PMID 14656622

M78) McCullough PA, Sandberg KR. Epidemiology of contrast-induced nephropathy.

Rev Cardiovasc Med. 2003;4 Suppl 5:S3-9. PMID 14668704 M79) Khanna A, McCullough PA. Malignant hypertension presenting as hemolysis,

thrombocytopenia, and renal failure. Rev Cardiovasc Med. 2003 Fall;4(4):255-9. PMID 14674379

M80) McCullough PA, Fonarow GC. B-type natriuretic peptide and multimarker approaches in

cardiovascular medicine. Rev Cardiovasc Med. 2003;4 Suppl 4:S1-2. PMID 14703686 M81) McCullough PA, Kuncheria J, Mathur VS. Diagnostic and therapeutic utility of B-type

natriuretic peptide in patients with renal insufficiency and decompensated heart failure. Rev Cardiovasc Med. 2003;4 Suppl 7:S3-S12. PMID 14668695

M82) Franklin BA, McCullough PA, Gordon S. Winter Storm Warning: Snow Removal May Be

Hazardous to Your (Patient's) Health. Curr Sports Med Rep. 2004 Apr;3(2):59-61. PMID 14980132

M83) Conaway DG, Sullivan RA, McCullough PA. Improved Symptoms, Physical Limitation, and

Self-Efficacy After Resynchronization in a Patient with Heart Failure and a Prolonged QRS Duration. Rev Cardiovasc Med. 2004 Winter;5(1):53-7. PMID 15029112

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M84) McCullough PA, Sandberg KR Chronic kidney disease and sudden death: strategies for prevention. Blood Purif. 2004;22(1):136-42. PMID 14732822

M85) Knudsen, CW, Omland, T, Clopton P, Westheim, A, Abraham, WT, Storrow AB, J McCord,

Nowak, RM, Steg, PG, Duc, P, McCullough, PA, Maisel, AS, for the BNP Multinational Study Investigators. Diagnostic Value of B-type Natriuretic Peptide and Chest Radiograph Findings in Patients with Acute Dyspnea. Am J Med. 2004 Mar 15;116(6):363-8. PMID 15006584

M86) McCullough PA, Gibson CM, Dibattiste PM, Demopoulos LA, Murphy SA, Weintraub WS,

Neumann FJ, Khanal S, Cannon CP; TACTICS-TIMI-18 INVESTIGATORS. Timing of Angiography and Revascularization in Acute Coronary Syndromes: J Interv Cardiol. 2004 Apr;17(2):81-86. PMID 15104769.

M87) McCullough PA. B-type natriuretic peptide and its clinical implications in heart failure. Am

Heart Hosp J 2004;2:26-33. M88) McCullough PA, Dorrell KA, Sandberg KR, Yerkey MW. Ximelagatran: a novel oral direct

thrombin inhibitor for long-term anticoagulation. Rev Cardiovasc Med. 2004 Spring;5(2):99-103. PMID 15184843.

M89) Maisel AS, Clopton P, Krishnaswamy P, Nowak RM, McCord J, Hollander JE, Duc P, Omland T,

Storrow AB, Abraham WT, Wu AH, Steg G, Westheim A, Knudsen CW, Perez A, Kazanegra R, Bhalla V, Herrmann HC, Aumont MC, McCullough PA; BNP Multinational Study Investigators. Impact of age, race, and sex on the ability of B-type natriuretic peptide to aid in the emergency diagnosis of heart failure: results from the Breathing Not Properly (BNP) multinational study. Am Heart J. 2004 Jun;147(6):1078-84. PMID 15199359.

M90) McCullough PA. Cardiovascular risk reduction and preservation of renal function in the early

nephropathy patient. Adv Chronic Kidney Dis. 2004 Apr;11(2):184-91. PMID 15216489. M91) Yerkey MW, Kernis SJ, Franklin BA, Sandberg KR, McCullough PA. Renal dysfunction and

acceleration of coronary disease. Heart. 2004 Aug;90(8):961-6. PMID 15253986 M92) McCullough PA, Soman S. Cardiovascular calcification in patients with chronic renal failure:

Are we on target with this risk factor? Kidney Int. 2004 Sep;66 Suppl 90:S18-24. PMID 15296503

M93) McCullough PA, Sandberg KR, Dumler F, Yanez JE. Determinants of coronary vascular

calcification in patients with chronic kidney disease and end-stage renal disease: a systematic review. J Nephrol. 2004 Mar-Apr;17(2):205-15. PMID 15293519

M94) McCullough PA. Opportunities for improvement in the cardiovascular care of patients with

end-stage renal disease. Adv Chronic Kidney Dis. 2004 Jul;11(3):294-303. PMID 15241743

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M95) Dumler F, McCullough PA. Optimal dialysis for the end-stage renal disease patient with cardiovascular disease. Adv Chronic Kidney Dis. 2004 Jul;11(3):261-73. PMID 15241741

M96) Keeley EC, McCullough PA. Coronary revascularization in patients with coronary artery

disease and chronic kidney disease. Adv Chronic Kidney Dis. 2004 Jul;11(3):254-60. PMID 15241740

M97) McCullough PA. Guest editorial: Cardiovascular care in end-stage renal disease. Adv

Chronic Kidney Dis. 2004 Jul;11(3):245. PMID 15241738 M98) McCullough PA, Bakris GL, Owen WF Jr, Klassen PS, Califf RM. Slowing the progression of

diabetic nephropathy and its cardiovascular consequences. Am Heart J. 2004 Aug;148(2):243-51. PMID 15308993

M99) Best PJ, Reddan DN, Berger PB, Szczech LA, McCullough PA, Califf RM. Cardiovascular

disease and chronic kidney disease: insights and an update. Am Heart J. 2004 Aug;148(2):230-42. PMID 15308992

M100) Bakris GL, Toto RD, McCullough PA. Rationale and design of a study comparing two fixed-

dose combination regimens to reduce albuminuria in patients with type II diabetes and hypertension. J Hum Hypertens. 2004 Sep 30 PMID 15457206.

M101) Wu AH, Omland T, Duc P, McCord J, Nowak RM, Hollander JE, Herrmann HC, Steg PG, Wold

Knudsen C, Storrow AB, Abraham WT, Perez A, Kamin R, Clopton P, Maisel AS, McCullough PA. Breathing Not Properly Multinational Study Investigators. The effect of diabetes on B-type natriuretic peptide concentrations in patients with acute dyspnea: an analysis from the Breathing Not Properly Multinational Study. Diabetes Care. 2004 Oct;27(10):2398-404. PMID 15451907

M102) McCullough PA, Franklin BA. Conventional risk factors and cardiac events--debunking an old

myth about prevalence. Rev Cardiovasc Med. 2004 Summer;5(3):185-6. PMID 15346104 M103) Maisel A, Hollander JE, Guss D, McCullough P, Nowak R, Green G, Saltzberg M, Ellison SR,

Bhalla MA, Bhalla V, Clopton P, Jesse R; Rapid Emergency Department Heart Failure Outpatient Trial investigators. Primary results of the Rapid Emergency Department Heart Failure Outpatient Trial (REDHOT): a multicenter study of B-type natriuretic peptide levels, emergency department decision making, and outcomes in patients presenting with shortness of breath. J Am Coll Cardiol. 2004 Sep 15;44(6):1328-33. PMID 15364340

M104) McCullough PA. Cardiovascular disease in chronic kidney disease from a cardiologist's

perspective. Curr Opin Nephrol Hypertens. 2004 Nov;13(6):591-600. PMID: 15483448

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M105) McCord J, Mundy BJ, Hudson MP, Maisel AS, Hollander JE, Abraham WT, Steg PG, Omland T, Knudsen CW, Sandberg KR, McCullough PA. Relationship between obesity and B-type natriuretic Peptide levels. Arch Intern Med. 2004 Nov 8;164(20):2247-52. PMID: 15534162

M106) Wase A, Basit A, Nazir R, Jamal A, Shah S, Khan T, Mohiuddin I, White C, Saklayen M,

McCullough PA. Impact of chronic kidney disease upon survival among implantable cardioverter-defibrillator recipients. J Interv Card Electrophysiol. 2004 Dec;11(3):199-204. PMID: 15548886

M107) McCullough PA. B-type natriuretic peptide and its clinical implications in heart failure. Am

Heart Hosp J. 2004 Winter;2(1):26-33. PMID: 15604836 M108) Silver MA, Maisel A, Yancy CW, McCullough PA, Burnett JC Jr., Francis GS, Mehra MR,

Peacock WF 4th, Fonarow G, Gibler WB, Morrow DA, Hollander J; BNP Consensus Panel. BNP Consensus Panel 2004: A clinical approach for the diagnostic, prognostic, screening, treatment monitoring, and therapeutic roles of natriuretic peptides in cardiovascular diseases. Congest Heart Fail. 2004 Sep-Oct;10(5 Suppl 3):1-30. PMID: 15604859

M109) McCullough PA. Preface. Ximelagatran and oral direct thrombin inhibition. Rev Cardiovasc

Med. 2004;5 Suppl 5:S1. PMID: 15619609 M110) Prystowsky EN, McCullough PA. Introduction: the role of oral direct thrombin inhibitors in

cardiovascular disease. Rev Cardiovasc Med. 2004;5 Suppl 5:S2-3. PMID: 15619611 M111) McCullough PA. Clinical applications of B-type natriuretic peptide levels in the care of

cardiovascular patients. Minerva Cardioangiol. 2004 Dec;52(6):479-89. PMID: 15729209 M112) Safley DM, Awad A, Sullivan RA, Sandberg KR, Mourad I, Boulware M, Merhi W, McCullough

PA. Changes in B-type natriuretic peptide levels in hemodialysis and the effect of depressed left ventricular function. Adv Chronic Kidney Dis. 2005 Jan;12(1):117-24. PMID: 15719344.

M113) McCullough PA, Khandelwal AK, McKinnon JE, Shenkman HJ, Pampati V, Nori D, Sullivan RA,

Sandberg KR, Kaatz S. Outcomes and prognostic factors of systolic as compared with diastolic heart failure in urban America. Congest Heart Fail. 2005 Jan-Feb;11(1):6-11. PMID: 15722664.

M114) McCullough PA, Lepor NE. The deadly triangle of anemia, renal insufficiency, and

cardiovascular disease: implications for prognosis and treatment. Rev Cardiovasc Med. 2005 Winter;6(1):1-10. PMID: 15741920

M115) El-Achkar TM, Ohmit SE, McCullough PA, Crook ED, Brown WW, Grimm R, Bakris GL, Keane

WF, Flack JM. Higher prevalence of anemia with diabetes mellitus in moderate kidney insufficiency: The Kidney Early Evaluation Program. Kidney Int. 2005 Apr;67(4):1483-8. PMID: 15780101

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M116) McCullough PA, Soman SS. Contrast-induced nephropathy. Crit Care Clin. 2005 Apr;21(2):261-80. PMID: 15781162

M117) McCullough PA. Evaluation and treatment of coronary artery disease in patients with end-

stage renal disease. Kidney Int Suppl. 2005 Jun;(95):s51-8. PMID: 15882314 M118) Knudsen CW, Clopton P, Westheim A, Klemsdal TO, Wu AH, Duc P, McCord J, Nowak RM,

Hollander JE, Storrow AB, Abraham WT, McCullough PA, Maisel AS, Omland T. Predictors of elevated B-type natriuretic peptide concentrations in dyspneic patients without heart failure: an analysis from the breathing not properly multinational study. Ann Emerg Med. 2005 Jun;45(6):573-80. PMID: 15940086

M119) Gallagher MJ, Franklin BA, Ehrman JK, Keteyian SJ, Brawner CA, deJong AT, McCullough PA.

Comparative Impact of Morbid Obesity vs Heart Failure on Cardiorespiratory Fitness. Chest. 2005 Jun;127(6):2197-203. PMID: 15947337

M120) Mehta SR, Cannon CP, Fox KA, Wallentin L, Boden WE, Spacek R, Widimsky P, McCullough

PA, Hunt D, Braunwald E, Yusuf S. Routine vs selective invasive strategies in patients with acute coronary syndromes: a collaborative meta-analysis of randomized trials. JAMA. 2005 Jun 15;293(23):2908-17. PMID: 15956636

M121) Merhi W, Dixon SR, O'Neill WW, Hanzel GS, McCullough PA. Percutaneous left ventricular

assist device in acute myocardial infarction and cardiogenic shock. Rev Cardiovasc Med. 2005 Spring;6(2):118-23. PMID: 15976733

M122) Gallagher MJ, McCullough PA. The role of B-type natriuretic peptide in the diagnosis and

treatment of decompensated heart failure. Int J Geriatric Cardiol 2004; September 1(1):21-28. M123) McCullough PA, Hassan SA, Pallekonda V, Sandberg KR, Nori DB, Soman SS, Bhatt S, Hudson

MP, Weaver WD. Bundle branch block patterns, age, renal dysfunction, and heart failure mortality. Int J Cardiol. 2005 Jul 10;102(2):303-8. PMID: 15982501

M124) Steg PG, Joubin L, McCord J, Abraham WT, Hollander JE, Omland T, Mentre F, McCullough

PA, Maisel AS. B-type natriuretic Peptide and echocardiographic determination of ejection fraction in the diagnosis of congestive heart failure in patients with acute dyspnea. Chest. 2005 Jul;128(1):21-9. PMID 16002911

M125) Gallagher MJ, McCullough PA. The emerging role of natriuretic peptides in the diagnosis

and treatment of decompensated heart failure. Curr Heart Fail Rep. 2004 Sep;1(3):129-35. PMID: 16036036

M126) McCullough PA, Sandberg KR, Miller WM, Odom JS, Sloan KC, de Jong AT, Nori KE, Irving SD,

Krause KR, Franklin BA. Substantial weight gain during adulthood: the road to bariatric surgery. Prev Cardiol. 2005 Summer;8(3):155-9. PMID 16034218

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M127) Miller WM, Nori Janosz KE, Yanez J, McCullough PA. Effects of weight loss and

pharmacotherapy on inflammatory markers of cardiovascular disease. Expert Rev Cardiovasc Ther. 2005 Jul;3(4):743-59. PMID 16076283

M128) Nori Janosz KE, Miller WM, Odom J, Lillystone M, McCullough PA. Optimal diabetes

management during medical weight loss for cardiovascular risk reduction. Expert Rev Cardiovasc Ther. 2005 Jul;3(4):761-75. PMID 16076284

M129) McCullough PA, Berman AD. Percutaneous coronary interventions in the high-risk renal

patient: strategies for renal protection and vascular protection. Cardiol Clin. 2005 Aug;23(3):299-310. PMID 16084279

M130) Luther SA, McCullough PA, Havranek EP, Rumsfeld JS, Jones PG, Heidenreich PA, Peterson

ED, Rathore SS, Krumholz HM, Weintraub WS, Spertus JA, Masoudi FA; for the Cardiovascular Outcomes Research Consortium. The Relationship Between B-type Natriuretic Peptide and Health Status in Patients With Heart Failure. J Card Fail. 2005 Aug;11(6):414-21. PMID 16105631

M131) Knudsen CW, Omland T, Clopton P, Westheim A, Wu AH, Duc P, McCord J, Nowak RM,

Hollander JE, Storrow AB, Abraham WT, McCullough PA, Maisel A. Impact of atrial fibrillation on the diagnostic performance of B-type natriuretic Peptide concentration in dyspneic patients an analysis from the breathing not properly multinational study. J Am Coll Cardiol. 2005 Sep 6;46(5):838-44. PMID 16139134

M132) McCullough PA. Chronic angina: new medical options for treatment. Rev Cardiovasc Med.

2005 Summer;6(3):152-61. PMID 16195688 M133) Spertus J, Peterson E, Conard MW, Heidenreich PA, Krumholz HM, Jones P, McCullough PA,

Pina I, Tooley J, Weintraub WS, Rumsfeld JS; Cardiovascular Outcomes Research Consortium. Monitoring clinical changes in patients with heart failure: a comparison of methods. Am Heart J. 2005 Oct;150(4):707-15. PMID 16209970

M134) McCullough PA. Effect of lipid modification on progression of coronary calcification. J Am

Soc Nephrol. 2005 Nov;16 Suppl 2:S115-9. PMID 16251246 M135) Wu AH, Omland T, Wold Knudsen C, McCord J, Nowak RM, Hollander JE, Duc P, Storrow AB,

Abraham WT, Clopton P, Maisel AS, McCullough PA. For The Breathing Not Properly Multinational Study Investigators. Relationship of B-type natriuretic peptide and anemia in patients with and without heart failure: A substudy from the Breathing Not Properly (BNP) Multinational Study. Am J Hematol. 2005 Oct 24;80(3):174-180. PMID 16247751

M136) Miller WM, Nori-Janosz KE, Lillystone M, Yanez J, McCullough PA. Obesity and lipids. Curr

Cardiol Rep. 2005 Nov;7(6):465-70. PMID 16256017

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M137) McCord J, Nowak RM, Jacobsen G, Sallach JA, Wu AH, Perez A, Omland T, Knudsen CW,

Westheim A, Duc P, Steg PG, Hollander JE, Herrmann HC, Storrow AB, Abraham WT, Lamba S, McCullough PA, Maisel A. B-Type Natriuretic Peptide Levels in Patients in the Emergency Department with Possible Heart Failure and Previous Stable Angina Pectoris and/or Healed Myocardial Infarction. Am J Cardiol. 2005 Nov 15;96(10):1370-3. Epub 2005 Sep 23. PMID 16275180

M138) Chinnaiyan KM, Alexander D, McCullough PA. Role of Angiotensin II in the Evolution of

Diastolic Heart Failure. J Clin Hypertens (Greenwich). 2005 Dec;7(12):740-7. PMID: 16330897 M139) McCullough PA. Symposium: cardiovascular diseases and renal insufficiency. Introduction.

Int J Geriatric Cardiol 2005; September 2005 2(3):130. M140) McCullough PA. Spectrum of cardiorenal disease. Int J Geriatric Cardiol 2005; September

2005 2(3):131-135. M141) McCullough PA, Lepor NE. Anemia: A Modifiable Risk Factor for Heart Disease. Rev

Cardiovasc Med. 2005;6 Suppl. 3:1-3. PMID: 16340932 M142) McCullough PA, Lepor NE. Piecing Together the Evidence on Anemia: The Link between

Chronic Kidney Disease and Cardiovascular Disease. Rev Cardiovasc Med. 2005;6 Suppl. 3:4-12. PMID: 16340933

M143) McCullough PA, Silver MA, Kennard ED, Kelsey SF, Michaels AD; IEPR Investigators. Impact

of body mass index on outcomes of enhanced external counterpulsation therapy. Am Heart J. 2006 Jan;151(1):139. PMID: 16368306

M144) Strunk A, Bhalla V, Clopton P, Nowak RM, McCord J, Hollander JE, Duc P, Storrow AB,

Abraham WT, Wu AHB, Steg G, Perez A, Kazanegra R, Herrmann HC, Aumont MC, McCullough PA, Maisel A, for the BNP Multinational Study Investigators. Impact of the history of congestive heart failure on the utility of B-type natriuretic peptide in the emergency diagnosis of heart failure: Results from the Breathing Not Properly Multinational Study. Am J Med 119(1):69.e1-69.e11, 2006. PMID: 16431187

M145) McCullough P. Outcomes of contrast-induced nephropathy: Experience in patients

undergoing cardiovascular intervention. Catheter Cardiovasc Interv. 2006 Mar;67(3):335-43. PMID: 16489569.

M146) McCullough PA, Mueller C, Yancy CW Jr. Overview of B-type natriuretic Peptide as a blood

test. Congest Heart Fail. 2006 Mar-Apr;12(2):99-102. PMID: 16596044 M147) McCullough PA. Ranolazine: Focusing on angina pectoris. Drugs Today (Barc). 2006

Mar;42(3):177-83. PMID: 16628259

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M148) Daniels LB, Clopton P, Bhalla V, Krishnaswamy P, Nowak RM, McCord J, Hollander JE, Duc P,

Omland T, Storrow AB, Abraham WT, Wu AH, Steg PG, Westheim A, Knudsen CW, Perez A, Kazanegra R, Herrmann HC, McCullough PA, Maisel AS. How obesity affects the cut-points for B-type natriuretic peptide in the diagnosis of acute heart failure. Results from the Breathing Not Properly Multinational Study. Am Heart J. 2006 May;151(5):1006-12. PMID: 16644321

M149) Brenden CK, Hollander JE, Guss D, McCullough PA, Nowak R, Green G, Saltzberg M, Ellison

SR, Bhalla MA, Bhalla V, Clopton P, Jesse R, Maisel AS; REDHOT Investigators. Gray zone BNP levels in heart failure patients in the emergency department: results from the Rapid Emergency Department Heart Failure Outpatient Trial (REDHOT) multicenter study. Am Heart J. 2006 May;151(5):1013-8. PMID: 16644322

M150) Daniels LB, Bhalla V, Clopton P, Hollander JE, Guss D, McCullough PA, Nowak R, Green G,

Saltzberg M, Ellison SR, Bhalla MA, Jesse R, Maisel A. B-Type Natriuretic Peptide (BNP) Levels and Ethnic Disparities in Perceived Severity of Heart Failure Results From the Rapid Emergency Department Heart Failure Outpatient Trial (REDHOT) Multicenter Study of BNP Levels and Emergency Department Decision Making in Patients Presenting With Shortness of Breath. J Card Fail. 2006 May;12(4):281-5. PMID: 16679261

M151) Hanzel GS, Downes M, McCullough PA. Editorial: Renal function after renal artery stenting.

J Geriatric Cardiol 2005;2(4):196-197. M152) Foley RN, McCullough PA. Editorial: Anemia and left ventricular hypertrophy in non-dialysis

chronic kidney disease. J Geriatric Cardiol 2005;2(4):195-196. M153) McCullough PA. Chronic kidney disease: tipping the scale to the benefit of angiotensin-

converting enzyme inhibitors in patients with coronary artery disease. Circulation. 2006 Jul 4;114(1):6-7. PMID: 16818827

M154) McCullough PA, Gallagher MJ, deJong AT, Sandberg KR, Trivax JE, Alexander D, Kasturi G,

Jafri SM, Krause KR, Chengelis DL, Moy J, Franklin BA. Cardiorespiratory fitness and short-term complications after bariatric surgery. Chest. 2006 Aug;130(2):517-25. PMID: 16899853

M155) Ochoa AB, DeJong A, Grayson D, Franklin B, McCullough P. Effect of enhanced external

counterpulsation on resting oxygen uptake in patients having previous coronary revascularization and in healthy volunteers. Am J Cardiol. 2006 Sep 1;98(5):613-5. Epub 2006 Jun 30. PMID: 16923446

M156) McCullough PA, Bertrand ME, Brinker JA, Stacul F. A meta-analysis of the renal safety of

isosmolar iodixanol compared with low-osmolar contrast media. J Am Coll Cardiol. 2006 Aug 15;48(4):692-9. Epub 2006 Jul 24. PMID: 16904536

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M157) McCullough PA, Wase A. Do implantable cardioverter-defibrillators improve survival in dialysis patients after cardiac arrest? Nat Clin Pract Nephrol. 2006 Feb;2(2):70-1. PMID: 16932394

M158) McCullough PA, Stacul F, Davidson C, Becker CR, Adam A, Lameire N, Tumlin J; CIN

Consensus Working Panel. Overview. Am J Cardiol. 2006 Sep 18;98(6S1):2-4. Epub 2006 Feb 13. PMID: 16949374.

M159) McCullough PA, Adam A, Becker CR, Davidson C, Lameire N, Stacul F, Tumlin J; CIN

Consensus Working Panel. Epidemiology and Prognostic Implications of Contrast-Induced Nephropathy. Am J Cardiol. 2006 Sep 18;98(6S1):5-13. Epub 2006 Feb 10. PMID: 16949375

M160) Tumlin J, Stacul F, Adam A, Becker CR, Davidson C, Lameire N, McCullough PA; CIN

Consensus Working Panel. Pathophysiology of Contrast-Induced Nephropathy. Am J Cardiol. 2006 Sep 18;98(6S1):14-20. Epub 2006 Feb 17. PMID: 16949376

M161) Lameire N, Adam A, Becker CR, Davidson C, McCullough PA, Stacul F, Tumlin J; CIN

Consensus Working Panel. Baseline Renal Function Screening. Am J Cardiol. 2006 Sep 18;98(6S1):21-26. Epub 2006 Feb 20. PMID: 16949377

M162) McCullough PA, Adam A, Becker CR, Davidson C, Lameire N, Stacul F, Tumlin J; CIN

Consensus Working Panel. Risk Prediction of Contrast-Induced Nephropathy. Am J Cardiol. 2006 Sep 18;98(6S1):27-36. Epub 2006 Feb 23. PMID: 16949378

M163) Becker CR, Davidson C, Lameire N, McCullough PA, Stacul F, Tumlin J, Adam A; CIN

Consensus Working Panel. High-Risk Situations and Procedures. Am J Cardiol. 2006 Sep 18;98(6S1):37-41. Epub 2006 Feb 20. PMID: 16949379

M164) Davidson C, Stacul F, McCullough PA, Tumlin J, Adam A, Lameire N, Becker CR; CIN

Consensus Working Panel. Contrast Medium Use. Am J Cardiol. 2006 Sep 18;98(6S1):42-58. Epub 2006 Mar 2. PMID: 16949380

M165) Stacul F, Adam A, Becker CR, Davidson C, Lameire N, McCullough PA, Tumlin J; CIN

Consensus Working Panel. Strategies to Reduce the Risk of Contrast-Induced Nephropathy. Am J Cardiol. 2006 Sep 18;98(6S1):59-77. Epub 2006 Mar 20. PMID: 16949381

M166) Vanhecke TE, Miller WM, Franklin BA, Weber JE, McCullough PA. Awareness, knowledge,

and perception of heart disease among adolescents. Eur J Cardiovasc Prev Rehabil. 2006 Oct;13(5):718-23. PMID: 17001210

M167) Zalesin KC, McCullough PA. Bariatric surgery for morbid obesity: risks and benefits in

chronic kidney disease patients. Adv Chronic Kidney Dis. 2006 Oct;13(4):403-17. PMID: 17045226

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M168) Michaels AD, McCullough PA, Soran OZ, Lawson WE, Barsness GW, Henry TD, Linnemeier G, Ochoa A, Kelsey SF, Kennard ED, for the IEPR Investigators. Primer: practical approach to the selection of patients for and application of EECP. Nature Clinical Practice Cardiovascular Medicine 2006; 3: 623-632. PMID: 17063167

M169) McCullough PA. Failure of beta-blockers in the reduction of perioperative events: where did

we go wrong? Am Heart J. 2006 Nov;152(5):815-8. PMID: 17070139 M170) McCullough PA. Renal safety of iodixanol. Expert Rev Cardiovasc Ther. 2006 Sep;4(5):655-

61. PMID: 17081087 M171) Vanhecke TE, Franklin BA, Lillystone MA, Sandberg KR, DeJong AT, Krause KR, Chengelis DL,

McCullough PA. Caloric Expenditure in the Morbidly Obese Using Dual Energy X-ray Absorptiometry. J Clin Densitom. 2006 Oct-Dec;9(4):438-44. Epub 2006 Sep 28. PMID: 17097530

M172) Conard MW, Haddock CK, Poston WS, Havranek E, McCullough P, Spertus J; Cardiovascular

Outcomes Research Consortium. Impact of obesity on the health status of heart failure patients. J Card Fail. 2006 Dec;12(9):700-6. PMID: 17174231

M173) McCullough PA, Stacul F, Becker CR, Adam A, Lameire N, Tumlin JA, Davidson CJ. Contrast-

Induced Nephropathy (CIN) Consensus Working Panel: Executive Summary. Rev Cardiovasc Med. 2006 Fall;7(4):177-97. PMID: 17224862

M174) Chinnaiyan KM, Alexander D, Maddens M, McCullough PA. Curriculum in cardiology:

integrated diagnosis and management of diastolic heart failure. Am Heart J. 2007 Feb;153(2):189-200. PMID: 17239676

M175) Vogel JA, Franklin BA, Zalesin KC, Trivax JE, Krause KR, Chengelis DL, McCullough PA.

Reduction in predicted coronary heart disease risk after substantial weight reduction after bariatric surgery. Am J Cardiol. 2007 Jan 15;99(2):222-6. Epub 2006 Nov 16. PMID: 17223422

M176) McCullough PA, Rocher LR. Statin therapy in renal disease: Harmful or protective. Curr

Atheroscler Rep. 2007 Jan;9(1):18-24. PMID: 17169242 M177) McCullough PA. [Cardiorenal intersection: crossroads to the future.] Arq Bras Cardiol. 2007

Jan;88(1):117-26. Portuguese Translation. PMID: 17364130 M178) Mehta L, Devlin W, McCullough PA, O'Neill WW, Skelding KA, Stone GW, Boura JA, Grines CL.

Impact of body mass index on outcomes after percutaneous coronary intervention in patients with acute myocardial infarction. Am J Cardiol. 2007 Apr 1;99(7):906-10. Epub 2007 Feb 12. PMID: 17398181

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M179) McCullough PA. Kidney disease. Estimated glomerular filtration rate: why is it important? Rev Cardiovasc Med. 2007 Winter;8(1):46-9. PMID: 17401304

M180) Lawson WE, Hui JC, Kennard ED, Soran O, McCullough PA, Kelsey SF; for the IEPR

Investigators. Effect of enhanced external counterpulsation on medically refractory angina patients with erectile dysfunction. Int J Clin Pract. 2007 May;61(5):757-62. PMID: 17493089

M181) McCullough PA, Jurkovitz CT, Pergola PE, McGill JB, Brown WW, Collins AJ, Chen SC, Li S,

Singh A, Norris KC, Klag MJ, Bakris GL; for the KEEP Investigators. Independent Components of Chronic Kidney Disease as a Cardiovascular Risk State: Results From the Kidney Early Evaluation Program (KEEP). Arch Intern Med. 2007 Jun 11;167(11):1122-9. PMID: 17563019

M182) McCullough PA. Coronary artery disease. Clin J Am Soc Nephrol. 2007 May;2(3):611-6. Epub

2007 Mar 21. PMID: 17699471 M183) McCullough PA, Lepor NE. The rosiglitazone meta-analysis. Rev Cardiovasc Med. 2007

Spring;8(2):123-6. PMID: 17603430 M184) McCullough PA, Henry TD, Kennard ED, Kelsey SF, Michaels AD; for the IEPR Investigators.

Residual high-grade angina after enhanced external counterpulsation therapy. Cardiovasc Revasc Med. 2007 Jul-Sep;8(3):161-5. PMID: 17765644

M185) Miller WM, Nori Janosz KE, Zalesin KC, McCullough PA. Nutraceutical meal replacements:

more effective than all-food diets in the treatment of obesity. Therapy 2007, 4(5):623-639. M186) Zalesin KC, Miller WM, Nori Janosz KE, Yanez J, Krause K, Chengelis DL, McCullough PA.

Controversies in vitamin D: deficiency and supplementation after Roux-en-Y gastric bypass surgery. Therapy 2007, 4(5):561-574.

M187) Li S, Chen SC, Shlipak M, Bakris G, McCullough PA, Sowers J, Stevens L, Jurkovitz C,

McFarlane S, Norris K, Vassalotti J, Klag MJ, Brown WW, Narva A, Calhoun D, Johnson B, Obialo C, Whaley-Connell A, Becker B, Collins AJ. Low birth weight is associated with chronic kidney disease only in men. Kidney Int. 2008 Mar;73(5):637-42. PMID: 18094674

M188) Duru OK, Li S, Jurkovitz C, Bakris G, Brown W, Chen SC, Collins A, Klag M, McCullough PA,

McGill J, Narva A, Pergola P, Singh A, Norris K. Race and Sex Differences in Hypertension Control in CKD: Results From the Kidney Early Evaluation Program (KEEP). Am J Kidney Dis. 2008 Feb;51(2):192-8. PMID: 18215697

M189) McCullough PA. Multimodality prevention of contrast-induced acute kidney injury. Am J

Kidney Dis. 2008 Feb;51(2):169-72. PMID: 18215694 M190) McCullough PA, Rocher LR. Statin therapy in renal disease: harmful or protective? Curr Diab

Rep. 2007 Dec;7(6):467-73. PMID: 18255012

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M191) Nori Janosz KE, Koenig Berris KA, Leff C, Miller WM, Yanez J, Myers S, Vial C, Vanderlinden M,

Franklin BA, McCullough PA. Clinical resolution of type 2 diabetes with reduction in body mass index using meal replacement based weight loss. Vascular Disease Prevention vol.5, 17-23(2008).

M192) Bellomo R, Auriemma S, Fabbri A, D'Onofrio A, Katz N, McCullough PA, Ricci Z, Shaw A,

Ronco C. The pathophysiology of cardiac surgery-associated acute kidney injury (CSA-AKI). Int J Artif Organs. 2008 Feb;31(2):166-78. PMID: 18311733

M193) Bakris GL, Toto RD, McCullough PA, Rocha R, Purkayastha D, Davis P; GUARD (Gauging

Albuminuria Reduction With Lotrel in Diabetic Patients With Hypertension) Study Investigators. Effects of different ACE inhibitor combinations on albuminuria: results of the GUARD study. Kidney Int. 2008 Jun;73(11):1303-9. Epub 2008 Mar 19. PMID: 18354383

M194) McCullough PA, Li S, Jurkovitz CT, Stevens LA, Wang C, Collins AJ, Chen SC, Norris KC,

McFarlane SI, Johnson B, Shlipak MG, Obialo CI, Brown WW, Vassalotti JA, Whaley-Connell AT; Kidney Early Evaluation Program Investigators. CKD and cardiovascular disease in screened high-risk volunteer and general populations: the Kidney Early Evaluation Program (KEEP) and National Health and Nutrition Examination Survey (NHANES) 1999-2004. Am J Kidney Dis. 2008 Apr;51(4 Suppl 2):S38-45. PMID: 18359407

M195) McFarlane SI, Chen SC, Whaley-Connell AT, Sowers JR, Vassalotti JA, Salifu MO, Li S, Wang C,

Bakris G, McCullough PA, Collins AJ, Norris KC; Kidney Early Evaluation Program Investigators. Prevalence and associations of anemia of CKD: Kidney Early Evaluation Program (KEEP) and National Health and Nutrition Examination Survey (NHANES) 1999-2004. Am J Kidney Dis. 2008 Apr;51(4 Suppl 2):S46-55. PMID: 18359408

M196) Vassalotti JA, Uribarri J, Chen SC, Li S, Wang C, Collins AJ, Calvo MS, Whaley-Connell AT,

McCullough PA, Norris KC; Kidney Early Evaluation Program Investigators. Trends in mineral metabolism: Kidney Early Evaluation Program (KEEP) and the National Health and Nutrition Examination Survey (NHANES) 1999-2004. Am J Kidney Dis. 2008 Apr;51(4 Suppl 2):S56-68. PMID: 18359409

M197) Whaley-Connell AT, Sowers JR, Stevens LA, McFarlane SI, Shlipak MG, Norris KC, Chen SC,

Qiu Y, Wang C, Li S, Vassalotti JA, Collins AJ; Kidney Early Evaluation Program Investigators. CKD in the United States: Kidney Early Evaluation Program (KEEP) and National Health and Nutrition Examination Survey (NHANES) 1999-2004. Am J Kidney Dis. 2008 Apr;51(4 Suppl 2):S13-20. PMID: 18359403

M198) Whaley-Connell AT, Sowers JR, McFarlane SI, Norris KC, Chen SC, Li S, Qiu Y, Wang C, Stevens

LA, Vassalotti JA, Collins AJ; Kidney Early Evaluation Program Investigators. Diabetes mellitus in CKD: Kidney Early Evaluation Program (KEEP) and National Health and Nutrition and Examination Survey (NHANES) 1999-2004. Am J Kidney Dis. 2008 Apr;51(4 Suppl 2):S21-9. PMID: 18359404

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M199) McCullough PA. Acute kidney injury with iodinated contrast. Crit Care Med. 2008 Apr;36(4

Suppl):S204-11. PMID: 18382195 M200) deJong AT, Gallagher MJ, Sandberg KR, Lillystone MA, Spring T, Franklin BA, McCullough PA.

Peak oxygen consumption and the minute ventilation/carbon dioxide production relation slope in morbidly obese men and women: influence of subject effort and body mass index. Prev Cardiol. 2008 Spring;11(2):100-5. PMID: 18401238

M201) McCullough PA. Contrast-induced acute kidney injury. J Am Coll Cardiol. 2008 Apr

15;51(15):1419-28. PMID: 18402894 M202) Vanhecke TE, Gandhi M, McCullough PA, Lazar MH, Ravikrishnan KP, Kadaj P, Begle RL.

Outcomes of patients considered for, but not admitted to, the intensive care unit. Crit Care Med. 2008 Mar;36(3):812-7. PMID: 18431268

M203) Zalesin KC, Krause KR, Chengelis DL, McCullough PA. Determinants of resolution of type 2

diabetes after bariatric surgery. Vascular Disease Prevention 2008;5(2):75-80. M204) Miller W, Odom J, Veri S, Korponic S, Lillystone M, McCullough PA. Impact of short-term

educational and behavioral therapy on childhood obesity. Vascular Disease Prevention 2008; 5(2):129-134.

M205) Vanhecke TE, Franklin BA, Ajluni SC, Sangal RB, McCullough PA. Cardiorespiratory fitness

and sleep-related breathing disorders. Expert Rev Cardiovasc Ther. 2008 Jun;6(5):745-58. PMID: 18510490

M206) Gebreegziabher Y, McCullough PA, Bubb C, Loney-Hutchinson L, Makaryus JN, Anand N,

Divakaran V, Akhrass P, Alam A, Gizycki H, McFarlane SI. Admission hyperglycemia and length of hospital stay in patients with diabetes and heart failure: a prospective cohort study. Congest Heart Fail. 2008 May-Jun;14(3):117-20. PMID: 18550921

M207) O'Donoghue M, Boden WE, Braunwald E, Cannon CP, Clayton TC, de Winter RJ, Fox KA,

Lagerqvist B, McCullough PA, Murphy SA, Spacek R, Swahn E, Wallentin L, Windhausen F, Sabatine MS. Early invasive vs conservative treatment strategies in women and men with unstable angina and non-ST-segment elevation myocardial infarction: a meta-analysis. JAMA. 2008 Jul 2;300(1):71-80. PMID: 18594042

M208) Franklin BA, McCullough PA. The "Null Effect" of Low-Density Lipoprotein Cholesterol

Lowering on a Modest Baseline Intima-Media Thickness: Lessons Learned From the ENHANCE Trial. Prev Cardiol. 2008 Summer;11(3):177-8.

M209) Agrawal V, Kizilbash SH, McCullough PA. New therapeutic agents for diabetic kidney disease.

Therapy. 2008 Jun;5(4):553-75.

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M210) Vanhecke TE, Berman AD, McCullough PA. Body weight limitations of United States cardiac

catheterization laboratories including restricted access for the morbidly obese. Am J Cardiol. 2008 Aug 1;102(3):285-6.

M211) Saab G, Whaley-Connell AT, McCullough PA, Bakris GL. CKD awareness in the United States:

the Kidney Early Evaluation Program (KEEP). Am J Kidney Dis. 2008 Aug;52(2):382-3. M212) McCullough PA, Li S, Jurkovitz CT, Stevens L, Collins AJ, Chen SC, Norris KC, McFarlane S,

Johnson B, Shlipak MG, Obialo CI, Brown WW, Vassaloti J, Whaley-Connell AT, Brenner RM, Bakris GL; KEEP Investigators. Chronic kidney disease, prevalence of premature cardiovascular disease, and relationship to short-term mortality. Am Heart J. 2008 Aug;156(2):277-83. Epub 2008 Jun 4. PMID: 18657657

M213) McCullough PA, Lepor NE. Lipids, biomarkers, and noninvasive imaging of atherosclerotic

disease activity in clinical trials. Rev Cardiovasc Med. 2008 Spring;9(2):142-9. PMID: 18660735 M214) McCullough PA, Agrawal V, Danielewicz E, Abela GS. Accelerated Atherosclerotic

Calcification and Mönckeberg’s Sclerosis: A Continuum of Advanced Vascular Pathology in Chronic Kidney Disease. Clin J Am Soc Nephrol. 2008 Nov;3(6):1585-98. PMID: 18667741

M215) Boerrigter G, Costello-Boerrigter LC, Abraham WT, Sutton MG, Heublein DM, Kruger KM, Hill

MR, McCullough PA, Burnett JC Jr. Cardiac resynchronization therapy improves renal function in human heart failure with reduced glomerular filtration rate. J Card Fail. 2008 Sep;14(7):539-46. Epub 2008 May 27. PMID: 18722318

M216) Zalesin KC, Franklin BA, Miller WM, Peterson ED, McCullough PA. Impact of obesity on

cardiovascular disease. Endocrinol Metab Clin North Am. 2008 Sep;37(3):663-84. PMID: 18775358

M217) Vanhecke TE, Franklin BA, Zalesin KC, Sangal RB, deJong AT, Agrawal V, McCullough PA.

Cardiorespiratory fitness and obstructive sleep apnea syndrome in morbidly obese patients. Chest. 2008 Sep;134(3):539-45. PMID: 18779193

M218) Madala MC, Franklin BA, Chen AY, Berman AD, Roe MT, Peterson ED, Ohman EM, Smith SC

Jr, Gibler WB, McCullough PA; CRUSADE Investigators. Obesity and Age of First Non-ST-Segment Elevation Myocardial Infarction. J Am Coll Cardiol. 2008 Sep 16;52(12):979-985. PMID: 18786477

M219) Agrawal V, Khan I, Rai B, Krause KR, Chengelis DL, Zalesin KC, Rocher LL, McCullough PA. The

effect of weight loss after bariatric surgery on albuminuria. Clin Nephrol. 2008 Sep;70(3):194-202. PMID: 18793560

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M220) Efstratiadis S, Kennard ED, Kelsey SF, Michaels AD; International EECP Patient Registry-2 Investigators.(McCullough PA, site Principal Investigator) Passive tobacco exposure may impair symptomatic improvement in patients with chronic angina undergoing enhanced external counterpulsation. BMC Cardiovasc Disord. 2008 Sep 17;8:23. PMID: 18798998

M221) McCullough PA. Radiocontrast-induced acute kidney injury. Nephron Physiol.

2008;109(4):p61-72. Epub 2008 Sep 18. PMID: 18802377 M222) McCullough PA. The impact of systemic calcified atherosclerosis in patients with chronic

kidney disease. Adv Chronic Kidney Dis. 2008 Oct;15(4):335-7. PMID: 18805378 M223) McCullough PA, Chinnaiyan KM, Agrawal V, Danielewicz E, Abela GS. Amplification of

atherosclerotic calcification and Mönckeberg's sclerosis: a spectrum of the same disease process. Adv Chronic Kidney Dis. 2008 Oct;15(4):396-412. PMID: 18805386

M224) Agrawal V, Krause KR, Chengelis DL, Zalesin KC, Rocher LL, McCullough PA. Relation

between degree of weight loss after bariatric surgery and reduction in albuminuria and C-reactive protein. Surg Obes Relat Dis. 2009 Jan-Feb;5(1):20-6. Epub 2008 Aug 5. PMID: 18951068

M225) Agrawal V, Ghosh AK, Barnes MA, McCullough PA. Awareness and Knowledge of Clinical

Practice Guidelines for CKD among Internal Medicine Residents: A National Online Survey. Am J Kidney Dis. 2008 Dec;52(6):1061-9. Epub 2008 Oct 30. PMID: 18976845

M226) Jamerson K, Weber MA, Bakris GL, Dahlöf B, Pitt B, Shi V, Hester A, Gupte J, Gatlin M,

Velazquez EJ; ACCOMPLISH Trial Investigators. Benazepril plus amlodipine or hydrochlorothiazide for hypertension in high-risk patients. (McCullough PA, Site Principal Investigator) N Engl J Med. 2008 Dec 4;359(23):2417-28. PMID: 19052124

M227) Flemmer M, Rajab H, Mathena T, Paulson J, Perkins S, Whelan T, Chiu R, McCullough PA.

Blood B-type natriuretic peptide and dialysis: present assessment and future analyses. South Med J. 2008 Nov;101(11):1094-100. PMID: 19088516

M228) Agrawal V, Ghosh AK, Barnes MA, McCullough PA. Perception of Indications for Nephrology

Referral among Internal Medicine Residents: A National Online Survey Clin J Am Soc Nephrol. 2009 Feb;4(2):323-8. PMID: 19218472

M229) Fried LF, Duckworth W, Zhang JH, O'Connor T, Brophy M, Emanuele N, Huang GD,

McCullough PA, Palevsky PM, Seliger S, Warren SR, Peduzzi P; for VA NEPHRON-D Investigators. Design of Combination Angiotensin Receptor Blocker and Angiotensin-Converting Enzyme Inhibitor for Treatment of Diabetic Nephropathy (VA NEPHRON-D). Clin J Am Soc Nephrol. 2009 Feb;4(2):361-8. Epub 2008 Dec 31. PMID: 19118120

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M230) Chinnaiyan KM, McCullough PA. Optimizing Outcomes in Coronary CT Imaging. Rev Cardiovasc Med. 2008 Fall;9(4):215-24. PMID: 19122579

M231) Cardenas GA, Lavie CJ, Cardenas V, Milani RV, McCullough PA. The importance of

recognizing and treating low levels of high-density lipoprotein cholesterol: a new era in atherosclerosis management. Rev Cardiovasc Med. 2008 Fall;9(4):239-58. PMID: 19122582

M232) Chinnaiyan KM, McCullough PA, Flohr TG, Wegner JH, Raff GL. Improved noninvasive

coronary angiography in morbidly obese patients with dual-source computed tomography. J Cardiovasc Comput Tomogr. 2008 Dec 3. PMID: 19136325

M233) Soman P, Lahiri A, Mieres JH, Calnon DA, Wolinsky D, Beller GA, Sias T, Burnham K, Conway

L, McCullough PA, Daher E, Walsh MN, Wight J, Heller GV, Udelson JE. Etiology and pathophysiology of new-onset heart failure: Evaluation by myocardial perfusion imaging. J Nucl Cardiol. 2009 Jan-Feb;16(1):82-91. Epub 2009 Jan 20. PMID: 19152132

M234) Goldfarb S, McCullough PA, McDermott J, Gay SB. Contrast-induced acute kidney injury:

specialty-specific protocols for interventional radiology, diagnostic computed tomography radiology, and interventional cardiology. Mayo Clin Proc. 2009 Feb;84(2):170-9. PMID: 19181651

M235) McCullough PA. Treatment disparities in patients with acute coronary syndromes and

kidney disease. Eur Heart J. 2009 Mar;30(5):526-7. PMID: 19201760 M236) Agrawal V, Ghosh AK, Barnes MA, McCullough PA. Perception of indications for nephrology

referral among internal medicine residents: a national online survey. Clin J Am Soc Nephrol. 2009 Feb;4(2):323-8. PMID: 19218472

M237) McCullough PA, Chinnaiyan KM. Hazards of contrast-induced acute kidney injury in elderly

women. Women’s Health (Lond Engl). 2009 Mar;5(2):123-5. PMID: 19245350 M238) Vanhecke TE, Franklin BA, Miller WM, deJong AT, Coleman CJ, McCullough PA.

Cardiorespiratory fitness and sedentary lifestyle in the morbidly obese. Clin Cardiol. 2009 Mar;32(3):121-4. PMID: 19301295

M239) Agrawal V, Marinescu V, Agarwal M, McCullough PA. Cardiovascular implications of

proteinuria: an indicator of chronic kidney disease. Nat Rev Cardiol. 2009 Apr;6(4):301-11. PMID:19352334

M240) O'Connor CM, Whellan DJ, Lee KL, Keteyian SJ, Cooper LS, Ellis SJ, Leifer ES, Kraus WE,

Kitzman DW, Blumenthal JA, Rendall DS, Miller NH, Fleg JL, Schulman KA, McKelvie RS, Zannad F, Piña IL; HF-ACTION Investigators.(McCullough PA Site Principal Investigator) Efficacy and safety of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled trial. JAMA. 2009 Apr 8;301(14):1439-50. PMID: 19351941

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M241) Vanhecke TE, Franklin BA, Maciejko J, Chinnaiyan K, McCullough PA. Lipoproteins,

inflammatory biomarkers, and cardiovascular imaging in the assessment of atherosclerotic disease activity. Rev Cardiovasc Med. 2009 Winter;10(1):51-8. PMID:19367236

M242) Miller WM, Franklin BA, Nori Janosz KE, Vial C, Kaitner R, McCullough PA. Advantages of

group treatment and structured exercise in promoting short-term weight loss and cardiovascular risk reduction in adults with central obesity. Metab Syndr Relat Disord 2009 May 18. PMID: 19450156

M243) Agrawal V, Swami A, Kosuri R, Alsabbagh M, Agarwal M, Samarapungavan D, Rocher LL,

McCullough PA. Contrast-induced acute kidney injury in renal transplant recipients after cardiac catheterization. Clin Nephrol. 2009 Jun;71(6):687-96. PMID: 19473638

M244) Janosz KE, Zalesin KC, Miller WM, McCullough PA, Franklin BA. Impact of surgical and

nonsurgical weight loss on diabetes resolution and cardiovascular risk reduction. Curr Diab Rep. 2009 Jun;9(3):223-8. PMID: 19490824

M245) McCullough PA, Neyou A. Comprehensive Review of the Relative Clinical Utility of B-Type

Natriuretic Peptide and N-Terminal Pro-B-Type Natriuretic Peptide Assays in Cardiovascular Disease. Open Heart Failure Journal, 2009, 2, 6-17.

M246) Odom J, Zalesin KC, Washington TL, Miller WW, Hakmeh B, Zaremba DL, Altattan M,

Balasubramaniam M, Gibbs DS, Krause KR, Chengelis DL, Franklin BA, McCullough PA. Behavioral Predictors of Weight Regain after Bariatric Surgery. Obes Surg. 2010 Mar;20(3):349-56 PMID: 19554382

M247) McCullough PA, Agarwal M, Agrawal V. Review article: Risks of coronary artery calcification

in chronic kidney disease: do the same rules apply? Nephrology (Carlton). 2009 Jun;14(4):428-36. PMID: 19563385

M248) Agrawal V, Shah A, Rice C, Franklin BA, McCullough PA. Impact of treating the metabolic

syndrome on chronic kidney disease. Nat Rev Nephrol. 2009 Sep;5(9):520-8. Epub 2009 Jul 28. Review. PMID: 19636332

M249) Moe SM, Drüeke TB, Block GA, Cannata-Andía JB, Elder G, Fukagawa M, Jorgetti V, Ketteler

M, Langman CB, Levin A, MacLeod AM, McCann L, McCullough PA, Ott SM, Wang AY, Weisinger JR, Wheeler DC, Eckardt KU, Kasiske BL, Uhlig K, Moorthi R, Earley A, Persson R. Introduction and definition of CKD-MBD and the development of the guideline statements. Kidney Int Suppl. 2009 Aug;(113):S1-130. PMID: 19644521

M250) McCullough PA. Darapladib and atherosclerotic plaque: should lipoprotein-associated

phospholipase A2 be a therapeutic target? Curr Atheroscler Rep. 2009 Sep;11(5):334-7. PMID: 19664375

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M251) Agrawal V, Vanhecke TE, Rai B, Franklin BA, Sangal RB, McCullough PA. Albuminuria and

Renal Function in Obese Adults Evaluated for Obstructive Sleep Apnea. Nephron Clin Pract. 2009 Aug 12;113(3):c140-c147. PMID: 19672111

M252) Agrawal V, Barnes MA, Ghosh AK, McCullough PA. Questionnaire instrument to assess

knowledge of chronic kidney disease clinical practice guidelines among internal medicine residents. J Eval Clin Pract. 2009 Aug;15(4):733-8. PMID: 19674226

M253) Franklin BA, McCullough PA. Cardiorespiratory fitness: an independent and additive marker

of risk stratification and health outcomes. Mayo Clin Proc. 2009 Sep;84(9):776-9. PMID: 19720774

M254) Lele S, Shah S, McCullough PA, Rajapurkar M. Serum catalytic iron as a novel biomarker of

vascular injury in acute coronary syndromes. EuroIntervention. 2009 Aug;5(3):336-42. PMID: 19736158

M255) McCullough PA, Hanzel GS. B-type natriuretic peptide and echocardiography in the

surveillance of severe mitral regurgitation prior to valve surgery. J Am Coll Cardiol. 2009 Sep 15;54(12):1107-9. PMID: 19744621

M256) Pahle AS, Sørli D, Omland T, Knudsen CW, Westheim A, Wu AH, Steg PG, McCord J, Nowak

RM, Hollander JE, Storrow AB, Abraham WT, McCullough PA, Maisel A. Impact of systemic hypertension on the diagnostic performance of B-type natriuretic peptide in patients with acute dyspnea. Am J Cardiol. 2009 Oct 1;104(7):966-71. PMID: 19766765

M257) McCullough PA. Commentary: contrast-induced nephropathy and long-term adverse

events: cause and effect? Nephrol Dial Transplant. 2009 Dec;24(12):3578-9. Epub 2009 Sep 25. PMID: 19783600

M258) Saab G, Whaley-Connell A, McFarlane SI, Li S, Chen SC, Sowers JR, McCullough PA, Bakris GL;

Kidney Early Evaluation Program Investigators. Obesity is associated with increased parathyroid hormone levels independent of glomerular filtration rate in chronic kidney disease. Metabolism. 2009 Oct 1. PMID: 19800639

M259) McMurray MD, Trivax JE, McCullough PA. Serum cystatin C, renal filtration function, and left

ventricular remodeling. Circ Heart Fail. 2009 Mar;2(2):86-9. PMID: 19808322 M260) Nori Janosz KE, Zalesin KC, Miller WM, McCullough PA. Treating type 2 diabetes: incretin

mimetics and enhancers. Ther Adv Cardiovasc Dis. 2009 Oct;3(5):387-95. PMID: 19808944 M261) Thakkar BV, Hirsch AT, Satran D, Bart BA, Barsness G, McCullough PA, Kennard ED, Kelsey SF,

Henry TD. The efficacy and safety of enhanced external counterpulsation in patients with

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peripheral arterial disease. Vasc Med. 2010 Feb;15(1):15-20. Epub 2009 Oct 19. PMID: 19841026

M262) Keteyian SJ, Isaac D, Thadani U, Roy BA, Bensimhon DR, McKelvie R, Russell SD, Hellkamp AS,

Kraus WE; HF-ACTION Investigators (McCullough PA Site Investigator). Safety of symptom-limited cardiopulmonary exercise testing in patients with chronic heart failure due to severe left ventricular systolic dysfunction. Am Heart J. 2009 Oct;158(4 Suppl):S72-7. PMID: 19782792

M263) Flynn KE, Lin L, Ellis SJ, Russell SD, Spertus JA, Whellan DJ, Piña IL, Fine LJ, Schulman KA,

Weinfurt KP; HF-ACTION Investigators (McCullough PA Site Investigator). Outcomes, health policy, and managed care: relationships between patient-reported outcome measures and clinical measures in outpatients with heart failure. Am Heart J. 2009 Oct;158(4 Suppl):S64-71. PMID: 19782791

M264) Forman DE, Clare R, Kitzman DW, Ellis SJ, Fleg JL, Chiara T, Fletcher G, Kraus WE; HF-ACTION

Investigators (McCullough PA). Relationship of age and exercise performance in patients with heart failure: the HF-ACTION study. Am Heart J. 2009 Oct;158(4 Suppl):S6-S15. PMID: 19782790

M265) Atchley AE, Kitzman DW, Whellan DJ, Iskandrian AE, Ellis SJ, Pagnanelli RA, Kao A, Abdul-

Nour K, O'Connor CM, Ewald G, Kraus WE, Borges-Neto S; HF-ACTION Investigators (McCullough PA). Myocardial perfusion, function, and dyssynchrony in patients with heart failure: baseline results from the single-photon emission computed tomography imaging ancillary study of the Heart Failure and A Controlled Trial Investigating Outcomes of Exercise TraiNing (HF-ACTION) Trial. Am Heart J. 2009 Oct;158(4 Suppl):S53-63. PMID: 19782789

M266) Gardin JM, Leifer ES, Fleg JL, Whellan D, Kokkinos P, Leblanc MH, Wolfel E, Kitzman DW; HF-

ACTION Investigators (McCullough PA). Relationship of Doppler-Echocardiographic left ventricular diastolic function to exercise performance in systolic heart failure: the HF-ACTION study. Am Heart J. 2009 Oct;158(4 Suppl):S45-52. PMID: 19782788

M267) Felker GM, Whellan D, Kraus WE, Clare R, Zannad F, Donahue M, Adams K, McKelvie R, Piña

IL, O'Connor CM; HF-ACTION Investigators (McCullough PA). N-terminal pro-brain natriuretic peptide and exercise capacity in chronic heart failure: data from the Heart Failure and a Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION) study. Am Heart J. 2009 Oct;158(4 Suppl):S37-44. PMID: 19782787

M268) Horwich TB, Leifer ES, Brawner CA, Fitz-Gerald MB, Fonarow GC; HF-ACTION Investigators

(McCullough PA). The relationship between body mass index and cardiopulmonary exercise testing in chronic systolic heart failure. Am Heart J. 2009 Oct;158(4 Suppl):S31-6. PMID: 19782786

M269) Russell SD, Saval MA, Robbins JL, Ellestad MH, Gottlieb SS, Handberg EM, Zhou Y, Chandler B;

HF-ACTION Investigators (McCullough PA). New York Heart Association functional class predicts

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exercise parameters in the current era. Am Heart J. 2009 Oct;158(4 Suppl):S24-30. PMID: 19782785

M270) Piña IL, Kokkinos P, Kao A, Bittner V, Saval M, Clare B, Goldberg L, Johnson M, Swank A,

Ventura H, Moe G, Fitz-Gerald M, Ellis SJ, Vest M, Cooper L, Whellan D; HF-ACTION Investigators (McCullough PA). Baseline differences in the HF-ACTION trial by sex. Am Heart J. 2009 Oct;158(4 Suppl):S16-23. PMID: 19782784

M271) O'Connor CM, Whellan DJ; HF-ACTION Investigators (McCullough PA). Understanding heart

failure through the HF-ACTION baseline characteristics. Am Heart J. 2009 Oct;158(4 Suppl):S1-5. PMID: 19782783

M272) McCullough PA, Tumlin JA. Prostaglandin-Based Renal Protection Against Contrast-Induced

Acute Kidney Injury. Circulation. 2009 Nov 3;120(18):1749-51. PMID: 19841295 M273) McCullough PA, Khan M, James J. Serum cystatin C in the estimation of glomerular filtration

on chronic Angiotensin-converting enzyme inhibitor therapy: an illustrative case report. J Clin Hypertens (Greenwich). 2009 Nov;11(11):651-5. PMID: 19878376

M274) Agrawal V, Agarwal M, Ghosh AK, Barnes MA, McCullough PA. Identification and

Management of Chronic Kidney Disease Complications by Internal Medicine Residents: A National Survey. Am J Ther. 2009 Nov 14. PMID: 19918169

M275) Zalesin KC, Franklin BA, Lillystone MA, Shamoun T, Krause KR, Chengelis DL, Mucci SJ,

Shaheen KW, McCullough PA. Differential Loss of Fat and Lean Mass in the Morbidly Obese after Bariatric Surgery. Metab Syndr Relat Disord. 2010 Feb;8(1):15-20. PMID: 19929598

M276) Lubanski MS, McCullough PA. Kidney's role in hypertension. Minerva Cardioangiol. 2009

Dec;57(6):743-59. PMID: 19942846 M277) Agrawal V, Rai B, Fellows J, McCullough PA. In-hospital outcomes with thrombolytic therapy

in patients with renal dysfunction presenting with acute ischaemic stroke. Nephrol Dial Transplant. 2010 Apr;25(4):1150-7. Epub 2009 Nov 27. PMID: 19945951

M278) McCullough PA, Chinnaiyan KM. Annual progression of coronary calcification in trials of

preventive therapies: a systematic review. Arch Intern Med. 2009 Dec 14;169(22):2064-70. PMID: 20008688

M279) Ronco C, McCullough P, Anker SD, Anand I, Aspromonte N, Bagshaw SM, Bellomo R, Berl T,

Bobek I, Cruz DN, Daliento L, Davenport A, Haapio M, Hillege H, House AA, Katz N, Maisel A, Mankad S, Zanco P, Mebazaa A, Palazzuoli A, Ronco F, Shaw A, Sheinfeld G, Soni S, Vescovo G, Zamperetti N, Ponikowski P; for the Acute Dialysis Quality Initiative (ADQI) consensus group. Cardio-renal syndromes: report from the consensus conference of the Acute Dialysis Quality Initiative. Eur Heart J. 2010 Mar;31(6):703-11. Epub 2009 Dec 25. PMID: 20037146

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M280) Whaley-Connell A, Pavey BS, McCullough PA, Saab G, Li S, McFarlane SI, Chen SC, Vassalotti

JA, Collins AJ, Bakris G, Sowers JR; KEEP Investigators. Dysglycemia predicts cardiovascular and kidney disease in the Kidney Early Evaluation Program. J Clin Hypertens (Greenwich). 2010 Jan;12(1):51-8. PMID: 20047632

M281) McCullough PA, Whaley-Connell A, Brown WW, Collins AJ, Chen SC, Li S, Norris KC, Jurkovitz

C, McFarlane S, Obialo C, Sowers J, Stevens L, Vassalotti JA, Bakris GL; on Behalf of the KEEP Investigators. Cardiovascular risk modification in participants with coronary disease screened by the Kidney Early Evaluation Program. Intern Med J. 2010 Dec;40(12):833-41. doi: 10.1111/j.1445-5994.2009.02158.x. PMID: 21199222

M282) Vassalotti JA, Li S, McCullough PA, Bakris GL. Kidney Early Evaluation Program: A Community-Based Screening Approach to Address Disparities in Chronic Kidney Disease. Semin Nephrol. 2010 Jan;30(1):66-73. PMID: 20116650

M283) Trivax JE, Franklin BA, Goldstein JA, Chinnaiyan KM, Gallagher MJ, Dejong AT, Colar JM,

Haines DE, McCullough PA. Acute Cardiac Effects of Marathon Running. J Appl Physiol. 2010 May;108(5):1148-53. Epub 2010 Feb 11. PMID: 20150567

M284) McCullough PA, Vassalotti JA, Collins AJ, Chen SC, Bakris GL. NKF's Kidney Early Evaluation

Program (KEEP) annual data report 2009: executive summary. Am J Kidney Dis. 2010 Mar;55(3 Suppl 2):S1-3. PMID: 20172443

M285) Stevens LA, Li S, Wang C, Huang C, Becker BN, Bomback AS, Brown WW, Burrows NR,

Jurkovitz CT, McFarlane SI, Norris KC, Shlipak M, Whaley-Connell AT, Chen SC, Bakris GL, McCullough PA. Prevalence of CKD and comorbid illness in elderly patients in the United States: results from the Kidney Early Evaluation Program (KEEP). Am J Kidney Dis. 2010 Mar;55(3 Suppl 2):S23-33.PMID: 20172445

M286) Bomback AS, Kshirsagar AV, Whaley-Connell AT, Chen SC, Li S, Klemmer PJ, McCullough PA,

Bakris GL. Racial differences in kidney function among individuals with obesity and metabolic syndrome: results from the Kidney Early Evaluation Program (KEEP). Am J Kidney Dis. 2010 Mar;55(3 Suppl 2):S4-S14.PMID: 20172446

M287) Bagshaw SM, Cruz DN, Aspromonte N, Daliento L, Ronco F, Sheinfeld G, Anker SD, Anand I,

Bellomo R, Berl T, Bobek I, Davenport A, Haapio M, Hillege H, House A, Katz N, Maisel A, Mankad S, McCullough P, Mebazaa A, Palazzuoli A, Ponikowski P, Shaw A, Soni S, Vescovo G, Zamperetti N, Zanco P, Ronco C; for the Acute Dialysis Quality Initiative (ADQI) Consensus Group. Epidemiology of cardio-renal syndromes: workgroup statements from the 7th ADQI Consensus Conference. Nephrol Dial Transplant. 2010 May;25(5):1406-16. Epub 2010 Feb 25. PMID: 20185818

M288) McCullough PA. Transplantation: Coronary angiography prior to renal transplantation. Nat

Rev Nephrol. 2010 Mar;6(3):136-7. PMID: 20186230

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M289) McCullough PA, Verrill TA. Cardiorenal interaction: appropriate treatment of cardiovascular

risk factors to improve outcomes in chronic kidney disease. Postgrad Med. 2010 Mar;122(2):25-34.PMID: 20203453

M290) Toth PP, McCullough PA, Wegner MS, Colley KJ. Lipoprotein-associated phospholipase A2:

role in atherosclerosis and utility as a cardiovascular biomarker. Expert Rev Cardiovasc Ther. 2010 Mar;8(3):425-38.PMID: 20222820

M291) Stolker JM, McCullough PA, Rao S, Inzucchi SE, Spertus JA, Maddox TM, Masoudi FA, Xiao L,

Kosiborod M. Pre-procedural glucose levels and the risk for contrast-induced acute kidney injury in patients undergoing coronary angiography. J Am Coll Cardiol. 2010 Apr 6;55(14):1433-40.PMID: 20359592

M292) House AA, Anand I, Bellomo R, Cruz D, Bobek I, Anker SD, Aspromonte N, Bagshaw S, Berl T,

Daliento L, Davenport A, Haapio M, Hillege H, McCullough P, Katz N, Maisel A, Mankad S, Zanco P, Mebazaa A, Palazzuoli A, Ronco F, Shaw A, Sheinfeld G, Soni S, Vescovo G, Zamperetti N, Ponikowski P, Ronco C; for the Acute Dialysis Quality Initiative (ADQI) consensus group. Definition and classification of Cardio-Renal Syndromes: workgroup statements from the 7th ADQI Consensus Conference. Nephrol Dial Transplant. 2010 May;25(5):1416-20. Epub 2010 Mar 12. PMID: 20228069

M293) Zalesin KC, Franklin, BA, Miller WL, Nori Janosz KE, Veri Silvia, Odom JO, McCullough PA.

Preventing Weight Regain After Bariatric Surgery: An Overview of Lifestyle and Psychosocial Modulators. American Journal of Lifestyle Medicine, Vol. 4, No. 2, 113-120 (2010) DOI:10.1177/1559827609351227

M294) McCullough PA, Haapio M, Mankad S, Zamperetti N, Massie B, Bellomo R, Berl T, Anker SD,

Anand I, Aspromonte N, Bagshaw SM, Bobek I, Cruz DN, Daliento L, Davenport A, Hillege H, House AA, Katz N, Maisel A, Mebazaa A, Palazzuoli A, Ponikowski P, Ronco F, Shaw A, Sheinfeld G, Soni S, Vescovo G, Zanco P, Ronco C, Berl T; for the Acute Dialysis Quality Initiative (ADQI) Consensus Group. Prevention of cardio-renal syndromes: workgroup statements from the 7th ADQI Consensus Conference. Nephrol Dial Transplant. 2010 Jun;25(6):1777-84. Epub 2010 Apr 6. PMID: 20375030

M295) Vanhecke TE, Kim R, Raheem SZ, McCullough PA. Myocardial ischemia in patients with

diastolic dysfunction and heart failure. Curr Cardiol Rep. 2010 May;12(3):216-22.PMID: 20424964

M296) Ronco C, McCullough PA, Anker SD, Anand I, Aspromonte N, Bagshaw SM, Bellomo R, Berl T,

Bobek I, Cruz DN, Daliento L, Davenport A, Haapio M, Hillege H, House A, Katz NM, Maisel A, Mankad S, Zanco P, Mebazaa A, Palazzuoli A, Ronco F, Shaw A, Sheinfeld G, Soni S, Vescovo G, Zamperetti N, Ponikowski P. Cardiorenal Syndromes: An Executive Summary from the

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Consensus Conference of the Acute Dialysis Quality Initiative (ADQI). Contrib Nephrol. 2010;165:54-67. Epub 2010 Apr 20.PMID: 20427956

M297) McCullough PA. Prevention of Cardiorenal Syndromes. Contrib Nephrol. 2010;165:101-111.

Epub 2010 Apr 20. PMID: 20427960

M298) Signori C, Zalesin KC, Franklin B, Miller WL, McCullough PA. Effect of Gastric Bypass on Vitamin D and Secondary Hyperparathyroidism. Obes Surg. 2010 Jul;20(7):949-52. PMID: 20443152

M299) Davenport A, Anker SD, Mebazaa A, Palazzuoli A, Vescovo G, Bellomo R, Ponikowski P, Anand

I, Aspromonte N, Bagshaw S, Berl T, Bobek I, Cruz DN, Daliento L, Haapio M, Hillege H, House A, Katz N, Maisel A, Mankad S, McCullough P, Ronco F, Shaw A, Sheinfeld G, Soni S, Zamperetti N, Zanco P, Ronco C; Acute Dialysis Quality Initiative (ADQI) consensus group. ADQI 7: the clinical management of the Cardio-Renal syndromes: work group statements from the 7th ADQI consensus conference. Nephrol Dial Transplant. 2010 Jul;25(7):2077-89. Epub 2010 May 20. PMID: 20494894

M300) Szczech LA, Granger CB, Dasta JF, Amin A, Peacock WF, McCullough PA, Devlin JW, Weir MR,

Katz JN, Anderson FA Jr, Wyman A, Varon J; for the Studying the Treatment of Acute Hypertension Investigators. Acute Kidney Injury and Cardiovascular Outcomes in Acute Severe Hypertension. Circulation. 2010 May 25;121(20):2183-91. Epub 2010 May 10. PMID: 20458014

M301) Sica D, Oren RM, Gottwald MD, Mills RM; Scios 351 Investigators.(McCullough PA,

Investigator) Natriuretic and neurohormonal responses to nesiritide, furosemide, and combined nesiritide and furosemide in patients with stable systolic dysfunction. Clin Cardiol. 2010 Jun;33(6):330-6.PMID: 20556802

M302) Soriano-Co M, Vanhecke TE, Franklin BA, Sangal RB, Hakmeh B, McCullough PA. Increased

central adiposity in morbidly obese patients with obstructive sleep apnoea. Intern Med J. 2011 Jul;41(7):560-6. PMID: 20546056

M303) McCullough PA, Zerka M, Heimbach E, Musialcyzk M, Spring T, deJong A, Jafri SS, Coleman C,

Washington T, Raheem S, Vanhecke T, Zalesin KC. Audiocardiography in the cardiovascular evaluation of the morbidly obese. Clin Physiol Funct Imaging. 2010 Sep;30(5):369-74. PMID: 20618361

M304) McCullough PA, Verrill T. Lessons learned from acute myocardial infarction in patients with

chronic kidney disease. J Intern Med. 2010 Jul;268(1):38-9. No abstract available. PMID: 20642644

M305) McCullough PA, Franklin BA, Leifer E, Fonarow GC. Impact of Reduced Kidney Function on

Cardiopulmonary Fitness in Patients with Systolic Heart Failure. Am J Nephrol. 2010 Jul 22;32(3):226-233. PMID: 20664198

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M306) Warnock DG, Muntner P, McCullough PA, Zhang X, McClure LA, Zakai N, Cushman M,

Newsome BB, Kewalramani R, Steffes MW, Howard G, McClellan WM; REGARDS Investigators. Kidney Function, Albuminuria, and All-Cause Mortality in the REGARDS (Reasons for Geographic and Racial Differences in Stroke) Study. Am J Kidney Dis. 2010 Nov;56(5):861-71. Epub 2010 Aug 8. PMID: 20692752

M307) McCullough PA. Editorial: Contrast-Induced Acute Kidney Injury: Shifting from Elective to

Urgent Coronary Intervention. J Interv Cardiol. 2010 Oct;23(5):467-9. doi: 10.1111/j.1540-8183.2010.00589.x. Epub 2010 Aug 19. PMID: 20731756

M308) Bomback AS, Rekhtman Y, Whaley-Connell AT, Kshirsagar AV, Sowers JR, Chen SC, Li S,

Chinnaiyan KM, Bakris GL, McCullough PA. Gestational diabetes alone, in the absence of subsequent diabetes, is associated with microalbuminuria: results from the Kidney Early Evaluation Program (KEEP). Diabetes Care. 2010 Dec;33(12):2586-91. Epub 2010 Aug 31. PMID: 20807871

M309) Neyou A, O'Neil B, Berman AD, Boura JA, McCullough PA. Determinants of markedly

increased B-type natriuretic peptide in patients with ST-segment elevation myocardial infarction. Am J Emerg Med. 2011 Feb;29(2):141-7. Epub 2010 Mar 25. PMID: 20825778

M310) McCullough PA. Integration of the clinical laboratory in cardiovascular medicine. Rev

Cardiovasc Med. 2010;11 Suppl 2:S1-2. PMID: 20700097

M311) Lepor NE, McCullough PA. Differential diagnosis and overlap of acute chest discomfort and dyspnea in the emergency department. Rev Cardiovasc Med. 2010;11 Suppl 2:S13-23.PMID: 20700098

M312) de Lemos JA, Peacock WF, McCullough PA. Natriuretic peptides in the prognosis and

management of acute coronary syndromes. Rev Cardiovasc Med. 2010;11 Suppl 2:S24-34.PMID: 20700099

M313) McCullough PA, Peacock WF, O'Neil B, de Lemos JA. Capturing the pathophysiology of acute

coronary syndromes with circulating biomarkers. Rev Cardiovasc Med. 2010;11 Suppl 2:S3-12.PMID: 20700100

M314) McCullough PA, Peacock WF, O'Neil B, de Lemos JA, Lepor NE, Berkowitz R. An evidence-

based algorithm for the use of B-type natriuretic testing in acute coronary syndromes. Rev Cardiovasc Med. 2010;11 Suppl 2:S51-65.PMID: 20700103

M315) Zalesin KC, Miller WM, Franklin B, Mudugal D, Rao Buragadda A, Boura J, Nori-Janosz K,

Chengelis DL, Krause KR, McCullough PA. Vitamin a deficiency after gastric bypass surgery: an underreported postoperative complication. J Obes. 2011;2011. pii: 760695. Epub 2010 Sep 14.PMID: 20871833

App000250


M316) Maisel AS, Katz N, Hillege HL, Shaw A, Zanco P, Bellomo R, Anand I, Anker SD, Aspromonte N,

Bagshaw SM, Berl T, Bobek I, Cruz DN, Daliento L, Davenport A, Haapio M, House AA, Mankad S, McCullough P, Mebazaa A, Palazzuoli A, Ponikowski P, Ronco F, Sheinfeld G, Soni S, Vescovo G, Zamperetti N, Ronco C; for the Acute Dialysis Quality Initiative (ADQI) consensus group. Biomarkers in kidney and heart disease. Nephrol Dial Transplant. 2011 Jan;26(1):62-74. Epub 2010 Oct 26 PMID: 20978142

M317) McCullough PA. Cardiorenal syndromes: pathophysiology to prevention. Int J Nephrol.

2010 Dec 1;2010:762590.PMID: 2115153

M318) McCullough PA, Whaley-Connell A, Brown WW, Collins AJ, Chen SC, Li S, Norris KC, Jurkovitz C, McFarlane S, Obialo C, Sowers J, Stevens L, Vassalotti JA, Bakris GL. Cardiovascular risk modification in participants with coronary disease screened by the Kidney Early Evaluation Program. Intern Med J. 2010 Dec;40(12):833-41. doi: 10.1111/j.1445-5994.2009.02158.x.PMID: 21199222

M319) Lubanski MS, Vanhecke TE, Chinnaiyan KM, Franklin BA, McCullough PA. Subclinical

coronary atherosclerosis identified by coronary computed tomographic angiography in asymptomatic morbidly obese patients. Heart Int. 2010 Dec 31;5(2):e15. PubMed PMID: 21977300

M320) Rose JJ, Vanhecke TE, McCullough PA. Subarachnoid hemorrhage with neurocardiogenic

stunning. Rev Cardiovasc Med. 2010 Fall;11(4):254-63. PMID: 21389917

M321) McCullough PA. Micronutrients and cardiorenal disease: insights into novel assessments and treatment. Blood Purif. 2011;31(1-3):177-85. Epub 2011 Jan 10. PMID: 21228587

M322) Alexander P, David S, McCullough PA. Drug-eluting coronary stents in patients with kidney

disease. Am J Kidney Dis. 2011 Feb;57(2):188-9. No abstract available. PMID: 21251538

M323) McCullough PA, Chinnaiyan KM, Gallagher MJ, Colar JM, Geddes T, Gold JM, Trivax JE. Changes in renal markers and acute kidney injury after marathon running. Nephrology (Carlton). 2011 Feb;16(2):194-9. doi: 10.1111/j.1440-1797.2010.01354.x. PMID: 21272132

M324) McCullough PA, Ahmad A. Cardiorenal syndromes. World J Cardiol. 2011 Jan 26;3(1):1-9.

PMID: 21286212

M325) Poirier P, Cornier MA, Mazzone T, Stiles S, Cummings S, Klein S, McCullough PA, Ren Fielding C, Franklin BA; on behalf of the AHA Obesity Committee of the Council on Nutrition, Physical Activity, and Metabolism. Bariatric Surgery and Cardiovascular Risk Factors: A Scientific Statement From the AHA. Circulation. 2011 Apr 19;123(15):1683-701. Epub 2011 Mar 14. PMID: 21403092

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M326) Goel SK, Bellovich K, McCullough PA. Treatment of severe metastatic calcification and calciphylaxis in dialysis patients. Goel SK, Bellovich K, McCullough PA. Int J Nephrol. 2011 Feb 24;2011:701603. PMID: 21423552

M327) McCullough PA, El-Ghoroury M, Yamasaki H. Early detection of acute kidney injury with

neutrophil gelatinase-associated lipocalin. J Am Coll Cardiol. 2011 Apr 26;57(17):1762-4. PMID: 21511112

M328) Madder RD, Hickman L, Crimmins GM, Puri M, Marinescu V, McCullough PA, Safian RD.

Validity of Estimated Glomerular Filtration Rates for Assessment of Baseline and Serial Renal Function in Patients with Atherosclerotic Renal Artery Stenosis: Implications for Clinical Trials of Renal Revascularization. Circ Cardiovasc Interv. 2011 Jun 1;4(3):219-25. Epub 2011 Apr 26. PMID: 21521835

M329) Whaley-Connell A, Sowers JR, McCullough PA. The role of oxidative stress in the metabolic

syndrome. Rev Cardiovasc Med. 2011;12(1):21-9. PMID: 21546885

M330) McCullough PA, Capasso P. Patient Discomfort Associated with the Use of Intra-arterial Iodinated Contrast Media: A Meta-Analysis of Comparative Randomized Controlled Trials. BMC Med Imaging. 2011 May 24;11:12. doi:10.1186/1471-2342-11-12. PMID: 21609484

M331) Friedewald VE, Emmett M, McCullough P, Yancy CW, Roberts WC. The Editor's Roundtable:

Anemia and Cardiovascular Disease. Am J Cardiol. 2011 Jun 1;107(11):1630-5. PMID: 21575751

M332) McCullough PA, Maynard RC. Treatment disparities in acute coronary syndromes, heart failure, and kidney disease. Contrib Nephrol. 2011;171:68-73. Epub 2011 May 23. PMID: 21625092

M333) McCullough PA, Vassalotti JA, Collins AJ, Chen SC, Bakris GL, Whaley-Connell AT. National

Kidney Foundation's Kidney Early Evaluation Program (KEEP) Annual Data Report 2010: Executive Summary. Am J Kidney Dis. 2011 Mar;57(3 Suppl 2):S1-3. PMID: 21338845

M334) McFarlane SI, McCullough PA, Sowers JR, Soe K, Chen SC, Li S, Vassalotti JA, Stevens LA,

Salifu MO, Kurella Tamura M, Bomback AS, Norris KC, Collins AJ, Bakris GL, Whaley-Connell AT; KEEP Steering Committee. Comparison of the CKD Epidemiology Collaboration (CKD-EPI) and Modification of Diet in Renal Disease (MDRD) Study Equations: Prevalence of and Risk Factors for Diabetes Mellitus in CKD in the Kidney Early Evaluation Program (KEEP). Am J Kidney Dis. 2011 Mar;57(3 Suppl 2):S24-31. PMID: 21338847

M335) McCullough PA, Brown WW, Gannon MR, Vassalotti JA, Collins AJ, Chen SC, Bakris GL,

Whaley-Connell AT. Sustainable Community-Based CKD Screening Methods Employed by the National Kidney Foundation's Kidney Early Evaluation Program (KEEP). Am J Kidney Dis. 2011 Mar;57(3 Suppl 2):S4-8. PMID: 21338848

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M336) Stevens LA, Li S, Kurella Tamura M, Chen SC, Vassalotti JA, Norris KC, Whaley-Connell AT, Bakris GL, McCullough PA. Comparison of the CKD Epidemiology Collaboration (CKD-EPI) and Modification of Diet in Renal Disease (MDRD) Study Equations: Risk Factors for and Complications of CKD and Mortality in the Kidney Early Evaluation Program (KEEP). Am J Kidney Dis. 2011 Mar;57(3 Suppl 2):S9-S16. PMID: 21338849

M337) Herzog CA, Asinger RW, Berger AK, Charytan DM, Díez J, Hart RG, Eckardt KU, Kasiske BL,

McCullough PA, Passman RS, DeLoach SS, Pun PH, Ritz E. Cardiovascular disease in chronic kidney disease. A clinical update from Kidney Disease: Improving Global Outcomes (KDIGO). Kidney Int. 2011 Sep;80(6):572-86. PMID: 21750584

M338) Gorges RD, Burke P, David W, Cole A, McCullough PA, David SW. Emerging practice patterns

and outcomes of percutaneous aortic balloon valvuloplasty in patients with severe aortic stenosis. Rev Cardiovasc Med. 2011;12(2):e60-7. PMID: 21796084

M339) Hanna K, Seder CW, Chengelis D, McCullough PA, Krause K. Shorter circular staple is height

associated with lower anastomotic stricture rate in laparoscopic gastric bypass. Surg Obes Relat Dis. 2012 Mar-Apr;8(2):181-4. PMID: 21798822

M340) Miller WM, Spring TJ, Zalesin KC, Kaeding KR, Nori Janosz KE, McCullough PA, Franklin BA.

Lower Than Predicted Resting Metabolic Rate Is Associated With Severely Impaired Cardiorespiratory Fitness in Obese Individuals. Obesity (Silver Spring). 2012 Mar;20(3):505-11. PMID: 21836645

M341) Zalesin KC, Franklin BA, Miller WM, Peterson ED, McCullough PA. Impact of obesity on

cardiovascular disease. Med Clin North Am. 2011 Sep;95(5):919-37. PMID: 21855700

M342) Khouri Y, Steigerwalt SP, Alsamara M, McCullough PA. What is the Ideal Blood Pressure Goal for Patients with Stage III or Higher Chronic Kidney Disease? Curr Cardiol Rep. 2011 Dec;13(6):492-501. PMID: 21887524

M343) Brown JR, McCullough PA, Splaine ME, Davies L, Ross CS, Dauerman HL, Robb JF, Boss R,

Goldberg DJ, Fedele FA, Kellett MA, Phillips WJ, Ver Lee PN, Nelson EC, Mackenzie TA, O'Connor GT, Sarnak MJ, Malenka DJ; for the Northern New England Cardiovascular Disease Study Group. How do centres begin the process to prevent contrast-induced acute kidney injury: a report from a new regional collaborative. BMJ Qual Saf. 2012 Jan;21(1):54-62. PMID: 21890755

M344) Horwich TB, Broderick S, Chen L, McCullough PA, Strzelczyk T, Kitzman DW, Fletcher G,

Safford RE, Ewald G, Fine LJ, Ellis SJ, Fonarow GC. Relation Among Body Mass Index, Exercise Training, and Outcomes in Chronic Systolic Heart Failure. Am J Cardiol. 2011 Dec 15;108(12):1754-9. PMID: 21907317

M345) McCullough PA, Khambatta S, Jazrawi A. Minimizing the renal toxicity of iodinated contrast.

Circulation. 2011 Sep 13;124(11):1210-1. PMID: 21911794

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M346) Marinescu V, McCullough PA. Nutritional and micronutrient determinants of idiopathic

dilated cardiomyopathy: diagnostic and therapeutic implications. Expert Rev Cardiovasc Ther. 2011 Sep;9(9):1161-70. PubMed PMID: 21932959

M347) McCullough PA, Brown JR. Effects of Intra-Arterial and Intravenous Iso-Osmolar Contrast

Medium (Iodixanol) on the Risk of Contrast-Induced Acute Kidney Injury: A Meta-Analysis. Cardiorenal Med. 2011;1(4):220-234. PMID: 22164156

M348) McCullough PA, Al-Ejel F, Maynard RC. Lipoprotein subfractions and particle size in end-

stage renal disease. Clin J Am Soc Nephrol. 2011 Dec;6(12):2738-9. PMID: 22157706

M349) Lepor NE, McCullough PA. Assessing appropriateness of coronary intervention. Rev Cardiovasc Med. 2011;12(3):170-1. PMID: 22145194

M350) McCullough PA, Ahmed AB, Zughaib MT, Glanz ED, Di Loreto MJ. Treatment of

hypertriglyceridemia with fibric Acid derivatives: impact on lipid subfractions and translation into a reduction in cardiovascular events. Rev Cardiovasc Med. 2011;12(4):173-85. PMID: 22249508.

M351) Palazzuoli A, Beltrami M, Nodari S, McCullough PA, Ronco C. Clinical impact of renal

dysfunction in heart failure. Rev Cardiovasc Med. 2011;12(4):186-99. PMID: 22249509.

M352) McCullough PA, Olobatoke A, Vanhecke TE. Galectin-3: a novel blood test for the evaluation and management of patients with heart failure. Rev Cardiovasc Med. 2011;12(4):200-10. PMID: 22249510.

M353) Vanhecke TE, Franklin BA, Soman P, Lahiri A, Mieres JH, Sias T, Calnon DA, Wolinsky D,

Udelson JE, McCullough PA. Influence of myocardial ischemia on outcomes in patients with systolic versus non-systolic heart failure. Am J Cardiovasc Dis. 2011;1(2):167-75. Epub 2011 Jul 27. PMID: 22254196.

M354) Whaley-Connell A, Bomback AS, McFarlane SI, Li S, Roberts T, Chen SC, Collins AJ, Norris K,

Bakris GL, Sowers JR, McCullough PA; on behalf of the Kidney Early Evaluation Program Investigators. Diabetic Cardiovascular Disease Predicts Chronic Kidney Disease Awareness in the Kidney Early Evaluation Program. Cardiorenal Med. 2011 Jan;1(1):45-52. Epub 2011 Jan 17. PMID: 22258465.

M355) Saab G, Whaley-Connell A, Bombeck A, Kurella Tamura M, Li S, Chen SC, McFarlane SI,

Sowers JR, Norris K, Bakris GL, McCullough PA; for the Kidney Early Evaluation Program Investigators. The Association between Parathyroid Hormone Levels and the Cardiorenal Metabolic Syndrome in Non-Diabetic Chronic Kidney Disease. Cardiorenal Med. 2011;1(2):123-130. Epub 2011 Apr 15. PMID: 22258399.

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M356) Trivax JE, McCullough PA. Phidippides Cardiomyopathy: A Review and Case Illustration. Clin Cardiol. 2012 Feb;35(2):69-73. PMID: 22222888.

M357) Peralta CA, Norris KC, Li S, Chang TI, Tamura MK, Jolly SE, Bakris G, McCullough PA, Shlipak

M; for the KEEP Investigators. Blood Pressure Components and End-stage Renal Disease in Persons With Chronic Kidney Disease: The Kidney Early Evaluation Program (KEEP). Arch Intern Med. 2012 Jan 9;172(1):41-47. PMID: 22232147.

M358) McCullough PA, Assad H. Diagnosis of Cardiovascular Disease in Patients with

Chronic Kidney Disease. Blood Purif. 2012 Jan 20;33(1-3):112-118. [Epub ahead of print] PubMed PMID: 22269967.

M359) Amin AP, Salisbury AC, McCullough PA, Gosch K, Spertus JA, Venkitachalam L, Stolker JM, Parikh CR, Masoudi FA, Jones PG, Kosiborod M. Trends in the incidence of acute kidney injury in patients hospitalized with acute myocardial infarction. Arch Intern Med. 2012 Feb 13;172(3):246-53. PubMed PMID: 22332157.

M360) Whaley-Connell AT, Vassalotti JA, Collins AJ, Chen SC, McCullough PA. National Kidney

Foundation's Kidney Early Evaluation Program (KEEP) Annual Data Report 2011: Executive Summary. Am J Kidney Dis. 2012 Mar;59(3 Suppl 2):S1-4. PubMed PMID: 22339897; PubMed Central PMCID: PMC3285421.

M361) Shah A, Fried LF, Chen SC, Qiu Y, Li S, Cavanaugh KL, Norris KC, Whaley-Connell AT, McCullough PA, Mehrotra R; KEEP Investigators. Associations Between Access to Care and Awareness of CKD. Am J Kidney Dis. 2012 Mar;59(3 Suppl 2):S16-23. PubMed PMID: 22339898.

M362) Jurkovitz CT, Elliott D, Li S, Saab G, Bomback AS, Norris KC, Chen SC, McCullough PA, Whaley-

Connell AT; KEEP Investigators. Physician Utilization, Risk-Factor Control, and CKD Progression Among Participants in the Kidney Early Evaluation Program (KEEP). Am J Kidney Dis. 2012 Mar;59(3 Suppl 2):S24-33. PubMed PMID: 22339899.

M363) Saab G, Chen SC, Li S, Bomback AS, Whaley-Connell AT, Jurkovitz CT, Norris KC, McCullough

PA; KEEP Investigators. Association of Physician Care With Mortality in Kidney Early Evaluation Program (KEEP) Participants. Am J Kidney Dis. 2012 Mar;59(3 Suppl 2):S34-9. PubMed PMID: 22339900.

M364) Agrawal V, Jaar BG, Frisby XY, Chen SC, Qiu Y, Li S, Whaley-Connell AT, McCullough PA,

Bomback AS; KEEP Investigators. Access to Health Care Among Adults Evaluated for CKD: Findings From the Kidney Early Evaluation Program (KEEP). Am J Kidney Dis. 2012 Mar;59(3 Suppl 2):S5-S15. PubMed PMID: 22339901.

M365) Ismail Y, Kasmikha Z, Green HL, McCullough PA. Cardio-renal syndrome type 1:

epidemiology, pathophysiology, and treatment. Semin Nephrol. 2012 Jan;32(1):18-25. PubMed PMID: 22365158.

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M366) Khambatta S, Farkouh ME, Wright RS, Reeder GS, McCullough PA, Smars PA, Hickson LJ, Best

PJ. Chronic kidney disease as a risk factor for acute coronary syndromes in patients presenting to the emergency room with chest pain. Transl Res. 2012 May;159(5):391-6. Epub 2012 Jan 9. PubMed PMID: 22500512.

M367) Whaley-Connell A, Shlipak MG, Inker LA, Kurella Tamura M, Bomback AS, Saab G, Szpunar

SM, McFarlane SI, Li S, Chen SC, Norris K, Bakris GL, McCullough PA; Kidney Early Evaluation Program Investigators. Awareness of Kidney Disease and Relationship to End-stage Renal Disease and Mortality. Am J Med. 2012 Jul;125(7):661-9. PubMed PMID: 22626510.

M368) McCullough PA, Williams FJ, Stivers DN, Cannon L, Dixon S, Alexander P, Runyan D, David S.

Neutrophil Gelatinase-Associated Lipocalin: A Novel Marker of Contrast Nephropathy Risk. Am J Nephrol. 2012 May 23;35(6):509-514. PubMed PMID: 22627273.

M369) O'Keefe JH, Patil HR, Lavie CJ, Magalski A, Vogel RA, McCullough PA. Potential adverse

cardiovascular effects from excessive endurance exercise. Mayo Clin Proc. 2012 Jun;87(6):587-95. PubMed PMID: 22677079.

M370) McCullough PA, Ali S. Cardiac and renal function in patients with type 2 diabetes who have

chronic kidney disease: potential effects of bardoxolone methyl. Drug Des Devel Ther. 2012;6:141-9. Epub 2012 Jun 14. PubMed PMID: 22787387; PubMed Central PMCID: PMC3392144.

M371) O'Donoghue ML, Vaidya A, Afsal R, Alfredsson J, Boden WE, Braunwald E, Cannon CP,

Clayton TC, de Winter RJ, Fox KA, Lagerqvist B, McCullough PA, Murphy SA, Spacek R, Swahn E, Windhausen F, Sabatine MS. An Invasive or Conservative Strategy in Patients With Diabetes Mellitus and Non-ST-Segment Elevation Acute Coronary Syndromes: A Collaborative Meta-Analysis of Randomized Trials. J Am Coll Cardiol. 2012 Jul 10;60(2):106-11. PubMed PMID: 22766336.

M372) Ronco C, Cicoira M, McCullough PA. Cardiorenal Syndrome Type 1: Pathophysiological

Crosstalk Leading to Combined Heart and Kidney Dysfunction in the Setting of Acutely Decompensated Heart Failure. J Am Coll Cardiol. 2012 Sep 18;60(12):1031-42. PubMed PMID: 22840531.

M373) Ronco C, Stacul F, McCullough PA. Subclinical acute kidney injury (AKI) due to iodine-based

contrast media. Eur Radiol. 2013 Feb;23(2):319-23. PubMed PMID: 22895617. M374) McCullough PA, Larsen T, Brown JR. Theophylline or aminophylline for the prevention of

contrast-induced acute kidney injury. Am J Kidney Dis. 2012 Sep;60(3):338-9. PubMed PMID: 22901629.

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M375) Patil HR, O'Keefe JH, Lavie CJ, Magalski A, Vogel RA, McCullough PA. Cardiovascular damage resulting from chronic excessive endurance exercise. Mo Med. 2012 Jul-Aug;109(4):312-21. PubMed PMID: 22953596.

M376) Bose S, Bomback AS, Mehta NN, Chen SC, Li S, Whaley-Connell A, Benjamin J, McCullough

PA. Dysglycemia but not lipids is associated with abnormal urinary albumin excretion in diabetic kidney disease: a report from the Kidney Early Evaluation Program (KEEP). BMC Nephrol. 2012 Sep 7;13:104. doi:10.1186/1471-2369-13-104. PubMed PMID: 22958709.

M377) Wilson GD, Geddes TJ, Pruetz BL, Thibodeau BJ, Murawka A, Colar JM, McCullough PA,

Trivax JE. SELDI-TOF-MS Serum Profiling Reveals Predictors of Cardiac MRI Changes in Marathon Runners. Int J Proteomics. 2012;2012:679301. Epub 2012 Sep 3. PubMed PMID: 22988506; PubMed Central PMCID: PMC3439948.

M378) McCullough PA, Cowan S. Mineralocorticoid receptor antagonists and mortality in heart

failure with concurrent atrial fibrillation. Circ Heart Fail. 2012 Sep 1;5(5):550-1. PubMed PMID: 22991404.

M379) Saab G, Bomback AS, McFarlane SI, Li S, Chen SC, McCullough PA, Whaley-Connell A; for the

Kidney Early Evaluation Program Investigators. The Association of Parathyroid Hormone with ESRD and Pre-ESRD Mortality in the Kidney Early Evaluation Program. J Clin Endocrinol Metab. 2012 Dec;97(12):4414-21. PubMed PMID: 23066118.

M380) Whaley-Connell A, Kurella Tamura M, McCullough PA. A Decade After the KDOQI CKD

Guidelines: Impact on the National Kidney Foundation's Kidney Early Evaluation Program (KEEP). Am J Kidney Dis. 2012 Nov;60(5):692-3. doi: 10.1053/j.ajkd.2012.08.008. PubMed PMID: 23067631.

M381) McCullough PA, Di Loreto MJ. Fibrates and cardiorenal outcomes. J Am Coll Cardiol. 2012

Nov 13;60(20):2072-3. doi: 10.1016/j.jacc.2012.06.058. Epub 2012 Oct 17. PubMed PMID: 23083778.

M382) Babayev R, Whaley-Connell A, Kshirsagar A, Klemmer P, Navaneethan S, Chen SC, Li S,

McCullough PA, Bakris G, Bomback A; KEEP Investigators. Association of Race and Body Mass Index With ESRD and Mortality in CKD Stages 3-4: Results From the Kidney Early Evaluation Program (KEEP). Am J Kidney Dis. 2013 Mar;61(3):404-12. PubMed PMID: 23260275.

M383) Pinto de Carvalho L, McCullough PA, Gao F, Sim LL, Tan HC, Foo D, Ooi YW, Richards AM,

Chan MY, Yeo TC. Renal function and anaemia in acute myocardial infarction. Int J Cardiol. 2013 Sep 30;168(2):1397-401. PubMed PMID: 23305857.

M384) Kashani K, Al-Khafaji A, Ardiles T, Artigas A, Bagshaw SM, Bell M, Bihorac A, Birkhahn R, Cely

CM, Chawla LS, Davison DL, Feldkamp T, Forni LG, Gong MN, Gunnerson KJ, Haase M, Hackett J, Honore PM, Hoste EA, Joannes-Boyau O, Joannidis M, Kim P, Koyner JL, Laskowitz DT, Lissauer

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ME, Marx G, McCullough PA, Mullaney S, Ostermann M, Rimmele T, Shapiro NI, Shaw AD, Shi J, Sprague AM, Vincent JL, Vinsonneau C, Wagner L, Walker MG, Wilkerson RG, Zacharowski K, Kellum JA. Discovery and validation of cell cycle arrest biomarkers in human acute kidney injury. Crit Care. 2013 Feb 6;17(1):R25. [Epub ahead of print] PubMed PMID: 23388612.

M385) Smith SW, Diercks DB, Nagurney JT, Hollander JE, Miller CD, Schrock JW, Singer AJ, Apple FS,

McCullough PA, Ruff CT, Sesma A Jr, Peacock WF. Central versus local adjudication of myocardial infarction in a cardiac biomarker trial. Am Heart J. 2013 Mar;165(3):273-279.e1. doi: 10.1016/j.ahj.2012.12.012. Epub 2013 Jan 26. PubMed PMID: 23453092.

M386) Whaley-Connell AT, Kurella Tamura M, Jurkovitz CT, Kosiborod M, McCullough PA.

Advances in CKD Detection and Determination of Prognosis: Executive Summary of the National Kidney Foundation-Kidney Early Evaluation Program (KEEP) 2012 Annual Data Report. Am J Kidney Dis. 2013 Apr;61(4 Suppl 2):S1-3. doi: 10.1053/j.ajkd.2013.01.006. PubMed PMID: 23507265; PubMed Central PMCID: PMC3608929.

M387) Amin AP, Whaley-Connell AT, Li S, Chen SC, McCullough PA, Kosiborod MN; KEEP

Investigators. The Synergistic Relationship Between Estimated GFR and Microalbuminuria in Predicting Long-term Progression to ESRD or Death in Patients With Diabetes: Results From the Kidney Early Evaluation Program (KEEP). Am J Kidney Dis. 2013 Apr;61(4 Suppl 2):S12-23. doi: 10.1053/j.ajkd.2013.01.005. PubMed PMID: 23507266.

M388) Jurkovitz CT, Li S, Norris KC, Saab G, Bomback AS, Whaley-Connell AT, McCullough PA; KEEP

Investigators. Association Between Lack of Health Insurance and Risk of Death and ESRD: Results From the Kidney Early Evaluation Program (KEEP). Am J Kidney Dis. 2013 Apr;61(4 Suppl 2):S24-32. doi: 10.1053/j.ajkd.2012.12.015. PubMed PMID: 23507267.

M389) Chang TI, Li S, Chen SC, Peralta CA, Shlipak MG, Fried LF, Whaley-Connell AT, McCullough PA,

Kurella Tamura M; KEEP Investigators. Risk Factors for ESRD in Individuals With Preserved Estimated GFR With and Without Albuminuria: Results From the Kidney Early Evaluation Program (KEEP). Am J Kidney Dis. 2013 Apr;61(4 Suppl 2):S4-S11. doi: 10.1053/j.ajkd.2012.12.016. PubMed PMID: 23507268.

M390) Narala KR, Hassan S, Lalonde TA, McCullough PA. Management of coronary atherosclerosis

and acute coronary syndromes in patients with chronic kidney disease. Curr Probl Cardiol. 2013 May;38(5):165-206. doi: 10.1016/j.cpcardiol.2012.12.004. PubMed PMID: 23590761.

M391) Mehrotra R, Peralta CA, Chen SC, Li S, Sachs M, Shah A, Norris K, Saab G, Whaley-Connell A,

Kestenbaum B, McCullough PA. No independent association of serum phosphorus with risk for death or progression to end-stage renal disease in a large screen for chronic kidney disease. Kidney Int. 2013 Nov;84(5):989-97. PubMed PMID: 23615501.

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M392) Runyan D, Feldman D, McCullough PA, David S, Saba S, Gorges R. Long-term Follow-up of Lesion-specific Outcomes Comparing Drug-eluting Stents and Bare Metal Stents in Diseased Saphenous Vein Grafts. Rev Cardiovasc Med. 2013;14(1):1-6. PubMed PMID: 23651982.

M393) Lepor NE, Fouchia DD, McCullough PA. New vistas for the treatment of obesity: turning the

tide against the leading cause of morbidity and cardiovascular mortality in the developed world. Rev Cardiovasc Med. 2013;14(1):20-40. PubMed PMID: 23651984.

M394) Weisbord SD, Gallagher M, Kaufman J, Cass A, Parikh CR, Chertow GM, Shunk KA,

McCullough PA, Fine MJ, Mor MK, Lew RA, Huang GD, Conner TA, Brophy MT, Lee J, Soliva S, Palevsky PM. Prevention of Contrast-Induced AKI: A Review of Published Trials and the Design of the Prevention of Serious Adverse Events following Angiography (PRESERVE) Trial. Clin J Am Soc Nephrol. 2013 Sep;8(9):1618-31. PubMed PMID: 23660180

M395) McCullough PA, Bouchard J, Waikar SS, Siew ED, Endre ZH, Goldstein SL, Koyner JL, Macedo

E, Doi K, Di Somma S, Lewington A, Thadhani R, Chakravarthi R, Ice C, Okusa MD, Duranteau J, Doran P, Yang L, Jaber BL, Meehan S, Kellum JA, Haase M, Murray PT, Cruz D, Maisel A, Bagshaw SM, Chawla LS, Mehta RL, Shaw AD, Ronco C. Implementation of Novel Biomarkers in the Diagnosis, Prognosis, and Management of Acute Kidney Injury: Executive Summary from the Tenth Consensus Conference of the Acute Dialysis Quality Initiative (ADQI). Contrib Nephrol. 2013;182:5-12. doi: 10.1159/000349962. Epub 2013 May 13. PubMed PMID: 23689652.

M396) McCullough PA, Shaw AD, Haase M, Bouchard J, Waikar SS, Siew ED, Murray PT, Mehta RL,

Ronco C. Diagnosis of acute kidney injury using functional and injury biomarkers: workgroup statements from the tenth acute dialysis quality initiative consensus conference. Contrib Nephrol. 2013;182:13-29. doi: 10.1159/000349963. Epub 2013 May 13. PubMed PMID: 23689653.

M397) McCullough PA, Kellum JA, Haase M, Müller C, Damman K, Murray PT, Cruz D, House AA,

Schmidt-Ott KM, Vescovo G, Bagshaw SM, Hoste EA, Briguori C, Braam B, Chawla LS, Costanzo MR, Tumlin JA, Herzog CA, Mehta RL, Rabb H, Shaw AD, Singbartl K, Ronco C. Pathophysiology of the Cardiorenal Syndromes: Executive Summary from the Eleventh Consensus Conference of the Acute Dialysis Quality Initiative (ADQI). Contrib Nephrol. 2013;182:82-98. doi: 10.1159/000349966. Epub 2013 May 13. PubMed PMID: 23689657.

M398) Haase M, Müller C, Damman K, Murray PT, Kellum JA, Ronco C, McCullough PA.

Pathogenesis of Cardiorenal Syndrome Type 1 in Acute Decompensated Heart Failure: Workgroup Statements from the Eleventh Consensus Conference of the Acute Dialysis Quality Initiative (ADQI). Contrib Nephrol. 2013;182:99-116. doi: 10.1159/000349969. Epub 2013 May 13. PubMed PMID: 23689658.

M399) Cruz DN, Schmidt-Ott KM, Vescovo G, House AA, Kellum JA, Ronco C, McCullough PA.

Pathophysiology of Cardiorenal Syndrome Type 2 in Stable Chronic Heart Failure: Workgroup Statements from the Eleventh Consensus Conference of the Acute Dialysis Quality Initiative

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(ADQI). Contrib Nephrol. 2013;182:117-36. doi: 10.1159/000349968. Epub 2013 May 13. PubMed PMID: 23689659.

M400) Bagshaw SM, Hoste EA, Braam B, Briguori C, Kellum JA, McCullough PA, Ronco C.

Cardiorenal syndrome type 3: pathophysiologic and epidemiologic considerations. Contrib Nephrol. 2013;182:137-57. doi: 10.1159/000349971. Epub 2013 May 13. PubMed PMID: 23689660.

M401) Tumlin JA, Costanzo MR, Chawla LS, Herzog CA, Kellum JA, McCullough PA, Ronco C.

Cardiorenal Syndrome Type 4: Insights on Clinical Presentation and Pathophysiology from the Eleventh Consensus Conference of the Acute Dialysis Quality Initiative (ADQI). Contrib Nephrol. 2013;182:158-73. doi: 10.1159/000349972. Epub 2013 May 13. PubMed PMID: 23689661.

M402) Mehta RL, Rabb H, Shaw AD, Singbartl K, Ronco C, McCullough PA, Kellum JA. Cardiorenal

Syndrome Type 5: Clinical Presentation, Pathophysiology and Management Strategies from the Eleventh Consensus Conference of the Acute Dialysis Quality Initiative (ADQI). Contrib Nephrol. 2013;182:174-94. doi: 10.1159/000349970. Epub 2013 May 13. PubMed PMID: 23689662.

M403) McCullough PA, Barnhart HX, Inrig JK, Reddan D, Sapp S, Patel UD, Singh AK, Szczech LA,

Califf RM. Cardiovascular Toxicity of Epoetin-Alfa in Patients with Chronic Kidney Disease. Am J Nephrol. 2013 May 25;37(6):549-558. PubMed PMID: 23735819.

M404) Memon I, Norris KC, Bomback AS, Peralta C, Li S, Chen SC, McCullough PA, Whaley-Connell

A, Jurkovitz C, Tamura MK, Saab G; for the Kidney Early Evaluation Program Investigators. The Association between Parathyroid Hormone Levels and Hemoglobin in Diabetic and Nondiabetic Participants in the National Kidney Foundation's Kidney Early Evaluation Program. Cardiorenal Med. 2013 Jul;3(2):120-127. Epub 2013 Jun 1. PubMed PMID: 23922552; PubMed Central PMCID: PMC3721130.

M405) McCullough PA, Barnard D, Clare R, Ellis SJ, Fleg JL, Fonarow GC, Franklin BA, Kilpatrick RD,

Kitzman DW, O'Connor CM, Piña IL, Thadani U, Thohan V, Whellan DJ; for the HF-ACTION Investigators. Anemia and Associated Clinical Outcomes in Patients With Heart Failure Due to Reduced Left Ventricular Systolic Function. Clin Cardiol. 2013 Oct;36(10):611-20. PubMed PMID: 23929781.

M406) Akrawinthawong K, Shaw MK, Kachner J, Apostolov EO, Basnakian AG, Shah S, Tilak J,

McCullough PA. Urine catalytic iron and neutrophil gelatinase-associated lipocalin as companion early markers of acute kidney injury after cardiac surgery: a prospective pilot study. Cardiorenal Med. 2013 Apr;3(1):7-16. doi: 10.1159/000346815. Epub 2013 Feb 6. PubMed PMID: 23946721; PubMed Central PMCID: PMC3743453.

M407) White WB, Cannon CP, Heller SR, Nissen SE, Bergenstal RM, Bakris GL, Perez AT, Fleck PR,

Mehta CR, Kupfer S, Wilson C, Cushman WC, Zannad F; EXAMINE Investigators. (McCullough PA,

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Data Safety Monitoring Board) Alogliptin after acute coronary syndrome in patients with type 2 diabetes. N Engl J Med. 2013 Oct 3;369(14):1327-35.

M408) McCullough PA, Akrawinthawong K. Ascorbic Acid for the Prevention of Contrast-Induced

Acute Kidney Injury. J Am Coll Cardiol. 2013 Dec 10;62(23):2176-7. PubMed PMID: 23994411.

M409) Ronco C, McCullough PA, Chawla LS. Kidney attack versus heart attack: evolution of classification and diagnostic criteria. Lancet. 2013 Sep 14;382(9896):939-40. doi: 10.1016/S0140-6736(13)61932-7. PubMed PMID: 24034297.

M410) Kurella Tamura M, Li S, Chen SC, Cavanaugh KL, Whaley-Connell AT, McCullough PA,

Mehrotra RL. Educational programs improve the preparation for dialysis and survival of patients with chronic kidney disease. Kidney Int. 2013 Sep 25. doi:10.1038/ki.2013.369. [Epub ahead of print] PubMed PMID: 24067435.

M411) Nasser M, Larsen TR, Waanbah B, Sidiqi I, McCullough PA. Hyperacute drug-induced

hepatitis with intravenous amiodarone: case report and review of the literature. Drug Health Patient Saf. 2013 Sep 26;5:191-198. PubMed PMID: 24109195.

M412) Larsen TR, Kinni V, Zaks J, David S, McCullough PA. A Lethal Case of Influenza and Type 5

Cardiorenal Syndrome. Blood Purif. 2013 Nov 1;36(2):112-115. PubMed PMID: 24192807.

M413) Fried LF, Emanuele N, Zhang JH, Brophy M, Conner TA, Duckworth W, Leehey DJ, McCullough PA, O'Connor T, Palevsky PM, Reilly RF, Seliger SL, Warren SR, Watnick S, Peduzzi P, Guarino P; VA NEPHRON-D Investigators. Combined Angiotensin inhibition for the treatment of diabetic nephropathy. N Engl J Med. 2013 Nov 14;369(20):1892-903.

M414) Parsa A, Kao WH, Xie D, Astor BC, Li M, Hsu CY, Feldman HI, Parekh RS, Kusek JW, Greene TH,

Fink JC, Anderson AH, Choi MJ, Wright JT Jr, Lash JP, Freedman BI, Ojo A, Winkler CA, Raj DS, Kopp JB, He J, Jensvold NG, Tao K, Lipkowitz MS, Appel LJ; AASK Study Investigators; CRIC Study Investigators (McCullough PA, External Advisory Panel). APOL1 risk variants, race, and progression of chronic kidney disease. N Engl J Med. 2013 Dec 5;369(23):2183-96.

M415) Costanzo MR, Chawla LS, Tumlin JA, Herzog CA, McCullough PA, Kellum JA, Ronco C. The role

of early and sufficient isolated venovenous ultrafiltration in heart failure patients with pulmonary and systemic congestion. Rev Cardiovasc Med. 2013;14(2-4):e123-33. PubMed PMID: 24448253.

M416) Maioli M, Toso A, Leoncini M, Musilli N, Bellandi F, Rosner MH, McCullough PA, Ronco C.

Pre-procedural Bioimpedance Vectorial Analysis of fluid status and prediction of Contrast-Induced Acute Kidney Injury. J Am Coll Cardiol. 2014 Jan 30. pii: S0735-1097(14)00339-8. doi: 10.1016/j.jacc.2014.01.025. [Epub ahead of print] PubMed PMID: 24530668.

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M417) Chawla LS, Herzog CA, Costanzo MR, Tumlin J, Kellum JA, McCullough PA, Ronco C; Acute Dialysis Quality Initiative (ADQI) XI Workgroup. Viewpoint: Proposal for a Functional Classification System of Heart Failure in Patients with End-Stage Renal Disease: Proceedings of the Acute Dialysis Quality Initiative (ADQI) XI Workgroup. J Am Coll Cardiol. 2014 Jan 30. pii: S0735-1097(14)00331-3. doi: 10.1016/j.jacc.2014.01.020. [Epub ahead of print] Review. PubMed PMID: 24530671.

M418) McCullough PA. Calling for Targeted Trials in Cardiorenal Syndromes. Am J Kidney Dis. 2014

Apr 5. pii: S0272-6386(14)00616-7. doi:10.1053/j.ajkd.2014.03.006. [Epub ahead of print] PubMed PMID: 24713221.

M419) Toth PP, Shah PK, Wilkinson MJ, Davidson MH, McCullough PA. Use of microsomal

triglyceride transfer protein inhibitors in patients with homozygous familial hypercholesterolemia: translating clinical trial experience into clinical practice. Rev Cardiovasc Med. 2014;15(1):1-10. PubMed PMID: 24762461.

M420) McCullough PA, Beaver TM, Bennett-Guerrero E, Emmett M, Fonarow GC, Goyal A, Herzog

CA, Kosiborod M, Palmer BF. Acute and chronic cardiovascular effects of hyperkalemia: new insights into prevention and clinical management. Rev Cardiovasc Med. 2014;15(1):11-23. PubMed PMID: 24762462.

M421) McCullough PA. Practical experience using galectin-3 in heart failure. Clin Chem Lab Med.

2014 May 8. pii:/j/cclm.ahead-of-print/cclm-2014-0278/cclm-2014-0278.xml. doi: 10.1515/cclm-2014-0278. [Epub ahead of print] PubMed PMID: 24810562

M422) Chin MP, Reisman SA, Bakris GL, O'Grady M, Linde PG, McCullough PA, Packham D, Vaziri

ND, Ward KW, Warnock DG, Meyer CJ. Mechanisms Contributing to Adverse Cardiovascular Events in Patients with Type 2 Diabetes Mellitus and Stage 4 Chronic Kidney Disease Treated with Bardoxolone Methyl. Am J Nephrol. 2014 Jun 3;39(6):499-508. [Epub ahead of print] PubMed PMID: 24903467.

M423) McCullough PA, Whaley-Connell AT, Vassalotti JA. The future of CKD detection: the role for

the Kidney Early Evaluation Program. Nephrol News Issues. 2014 Apr;28(4):41-2. PubMed PMID: 24960988.

M424) Palazzuoli A, Pellegrini M, Ruocco G, Martini G, Franci B, Campagna MS, Gilleman M, Nuti R,

McCullough PA, Ronco C. Continuous versus bolus intermittent loop diuretic infusion in acutely decompensated heart failure: a prospective randomized trial. Crit Care. 2014 Jun 28;18(3):R134. doi: 10.1186/cc13952. PubMed PMID: 24974232.

M425) Manatsathit W, Al-Hamid H, Leelasinjaroen P, Hashmi U, McCullough PA. Management of

gastrointestinal bleeding in patients anticoagulated with dabigatran compared with warfarin: a retrospective, comparative case review. Cardiovasc Diagn Ther. 2014 Jun;4(3):224-31. doi:

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10.3978/j.issn.2223-3652.2014.03.07. PubMed PMID: 25009791; PubMed Central PMCID: PMC4069982.

M426) Neath SX, Jefferies JL, Berger JS, Wu AH, McConnell JP, Boone JL, McCullough PA, Jesse RL,

Maisel AS. The current and future landscape of urinary thromboxane testing to evaluate atherothrombotic risk. Rev Cardiovasc Med. 2014;15(2):119-30. Review. PubMed PMID: 25051129.

M427) Brown JR, Solomon RJ, Sarnak MJ, McCullough PA, Splaine ME, Davies L, Ross CS, Dauerman

HL, Stender JL, Conley SM, Robb JF, Chaisson K, Boss R, Lambert P, Goldberg DJ, Lucier D, Fedele FA, Kellett MA, Horton S, Phillips WJ, Downs C, Wiseman A, MacKenzie TA, Malenka DJ; for the Northern New England Cardiovascular Disease Study Group. Reducing Contrast-Induced Acute Kidney Injury Using a Regional Multicenter Quality Improvement Intervention. Circ Cardiovasc Qual Outcomes. 2014 Jul 29. pii: CIRCOUTCOMES.114.000903. [Epub ahead of print] PubMed PMID: 25074372.

M428) Zimering MB, Zhang JH, Guarino PD, Emanuele N, McCullough PA, Fried LF; Investigators for

the VA NEPHRON-D. Endothelial cell autoantibodies in predicting declining renal function, end-stage renal disease, or death in adult type 2 diabetic nephropathy. Front Endocrinol (Lausanne). 2014 Aug 11;5:128. doi: 10.3389/fendo.2014.00128. eCollection 2014. PubMed PMID: 25157242; PubMed Central PMCID: PMC4127944.

M429) McCullough PA, Kellum JA, Haase M, Müller C, Damman K, Murray PT, Cruz D, House AA,

Schmidt-Ott KM, Vescovo G, Bagshaw SM, Hoste EA, Briguori C, Braam B, Chawla LS, Costanzo MR, Tumlin JA, Herzog CA, Mehta RL, Rabb H, Shaw AD, Singbartl K, Ronco C. Pathophysiology of the Cardiorenal Syndromes: Executive Summary from the Eleventh Consensus Conference of the Acute Dialysis Quality Initiative (ADQI). Blood Purif. 2014;37 Suppl 2:2-13. doi: 10.1159/000361059. Epub 2014 Jul 31. PubMed PMID: 25196564.

M430) Hoste EA, McCullough PA, Kashani K, Chawla LS, Joannidis M, Shaw AD, Feldkamp T,

Uettwiller-Geiger DL, McCarthy P, Shi J, Walker MG, Kellum JA; for the Sapphire Investigators. Derivation and validation of cutoffs for clinical use of cell cycle arrest biomarkers. Nephrol Dial Transplant. 2014 Sep 18. pii: gfu292. [Epub ahead of print] PubMed PMID: 25237065.

M431) Chin MP, Wrolstad D, Bakris GL, Chertow GM, de Zeeuw D, Goldsberry A, Linde PG,

McCullough PA, McMurray JJ, Wittes J, Meyer CJ. Risk factors for heart failure in patients with type 2 diabetes mellitus and stage 4 chronic kidney disease treated with bardoxolone methyl. J Card Fail. 2014 Dec;20(12):953-8. doi:10.1016/j.cardfail.2014.10.001. Epub 2014 Oct 13. PubMed PMID: 25307295.

M432) McCullough PA, Fazel P, Choi JW. Screening, diagnosis, and management of CAD in

asymptomatic diabetic patients. JACC Cardiovasc Imaging. 2014 Oct;7(10):1011-2. doi: 10.1016/j.jcmg.2014.08.001. PubMed PMID: 25323163.

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M433) Hundae A, McCullough PA. Cardiac and renal fibrosis in chronic cardiorenal syndromes. Nephron Clin Pract. 2014;127(1-4):106-12. doi: 10.1159/000363705. Epub 2014 Sep 24. PubMed PMID: 25343831.

M434) Shin HJ, McCullough PA. Focus on lipids: high-density lipoprotein cholesterol and its

associated lipoproteins in cardiac and renal disease. Nephron Clin Pract. 2014;127(1-4):158-64. doi: 10.1159/000363552. Epub 2014 Sep 24. PubMed PMID:25343842.

M435) Ball T, McCullough PA. Statins for the prevention of contrast-induced acute kidney injury.

Nephron Clin Pract. 2014;127(1-4):165-71. doi: 10.1159/000363202. Epub 2014 Sep 24. PubMed PMID: 25343843.

M436) Szczech LA, Stewart RC, Su HL, DeLoskey RJ, Astor BC, Fox CH, McCullough PA, Vassalotti JA.

Primary Care Detection of Chronic Kidney Disease in Adults with Type-2 Diabetes: The ADD-CKD Study (Awareness, Detection and Drug Therapy in Type 2 Diabetes and Chronic Kidney Disease). PLoS One. 2014 Nov 26;9(11):e110535. doi: 10.1371/journal.pone.0110535. eCollection 2014. PubMed PMID: 25427285; PubMed Central PMCID: PMC4245114.

M437) McCullough PA, Roberts WC. Peter Andrew McCullough, MD, MPH: An Interview With the

Editor. Am J Cardiol. 2014 Dec 1;114(11):1772-85. doi: 10.1016/j.amjcard.2014.08.034. Epub 2014 Sep 16. PubMed PMID: 25439453.

M438) Roberts JK, McCullough PA. The Management of Acute Coronary Syndromes in Patients With

Chronic Kidney Disease. Adv Chronic Kidney Dis. 2014 Nov;21(6):472-479. doi: 10.1053/j.ackd.2014.08.005. Epub 2014 Oct 24. Review. PubMed PMID: 25443572.

M439) McCullough PA, Jefferies JL. Novel Markers and Therapies for Patients with Acute Heart

Failure and Renal Dysfunction. Am J Med. 2014 Nov 13. pii: S0002-9343(14)00977-2. doi: 10.1016/j.amjmed.2014.10.035. [Epub ahead of print] PubMed PMID: 25446297.

M440) Ball T, Wheelan K, McCullough PA. Chronic anticoagulation in chronic kidney disease. J Am

Coll Cardiol. 2014 Dec 16;64(23):2483-5. doi: 10.1016/j.jacc.2014.09.052. PubMed PMID: 25500232.

M441) Akrawinthawong K, Ricci J, Cannon L, Dixon S, Kupfer K, Stivers D, Alexander P, David S,

McCullough PA. Subclinical and clinical contrast-induced acute kidney injury: data from a novel blood marker for determining the risk of developing contrast-induced nephropathy (ENCINO), a prospective study. Ren Fail. 2014 Dec 18:1-5. [Epub ahead of print] PubMed PMID: 25519207.

M442) McCullough PA, Mehta A, Szerlip H. Improving detection of cardiac surgery-associated acute

kidney injury. J Am Coll Cardiol. 2014 Dec 30;64(25):2763-4. doi: 10.1016/j.jacc.2014.09.065. PubMed PMID: 25541129.

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M443) Lepor NE, Fouchia DD, McCullough PA. New vistas for the treatment of obesity: turning the tide against the leading cause of morbidity and cardiovascular mortality in the developed world. Rev Cardiovasc Med. 2014;15 Suppl 2:S1-19; quiz S20-1. Review. PubMed PMID: 25662755.

M444) Watson KE, Stocker EH, Jacoby DS, McCullough PA. Advanced lipid testing: when, why, and

in whom? Rev Cardiovasc Med. 2014;15(4):310-7; quiz 318-9. Review. PubMed PMID: 25662925.

M445) Charytan DM, Fishbane S, Malyszko J, McCullough PA, Goldsmith D. Cardiorenal Syndrome

and the Role of the Bone-Mineral Axis and Anemia. Am J Kidney Dis. 2015 Feb 26. pii: S0272-6386(15)00084-0. doi: 10.1053/j.ajkd.2014.12.016. [Epub ahead of print] PubMed PMID: 25727384.

M446) Kassis HM, Minsinger KD, McCullough PA, Block CA, Sidhu MS, Brown JR. A Review of the

Use of Iloprost, A Synthetic Prostacyclin, in the Prevention of Radiocontrast Nephropathy in Patients Undergoing Coronary Angiography and Intervention. Clin Cardiol. 2015 May 12. doi: 10.1002/clc.22407. [Epub ahead of print] PubMed PMID: 25963191.

M447) Palazzuoli A, McCullough PA, Ronco C, Nuti R. Kidney disease in heart failure: the

importance of novel biomarkers for type 1 cardio-renal syndrome detection. Intern Emerg Med. 2015 May 14. [Epub ahead of print] PubMed PMID: 25972236.

M448) Robinson JG, Farnier M, Krempf M, Bergeron J, Luc G, Averna M, Stroes ES, Langslet G, Raal

FJ, El Shahawy M, Koren MJ, Lepor NE, Lorenzato C, Pordy R, Chaudhari U, Kastelein JJ; ODYSSEY LONG TERM Investigators (McCullough PA Site PI). Efficacy and safety of alirocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015 Apr 16;372(16):1489-99. doi: 10.1056/NEJMoa1501031. Epub 2015 Mar 15. PubMed PMID: 25773378.

M449) McCullough PA, Costanzo MR, Silver M, Spinowitz B, Zhang J, Lepor NE. Novel Agents for the

Prevention and Management of Hyperkalemia. Rev Cardiovasc Med. 2015;16(2):140-55. PubMed PMID: 26198561.

M450) McCullough PA, Patanker G, Stoler RC. Estimating Renal Filtration, Drug Dosing, and Clinical

Outcomes. J Am Coll Cardiol. 2015 Jun 30;65(25):2724-5. doi: 10.1016/j.jacc.2015.05.015. PubMed PMID: 26112196.

M451) Husain-Syed F, McCullough PA, Birk HW, Renker M, Brocca A, Seeger W, Ronco C. Cardio-

Pulmonary-Renal Interactions: A Multidisciplinary Approach. J Am Coll Cardiol. 2015 Jun 9;65(22):2433-48. doi: 10.1016/j.jacc.2015.04.024. Review. PubMed PMID: 26046738.

M452) Anker SD, Kosiborod M, Zannad F, Piña IL, McCullough PA, Filippatos G, van der Meer P,

Ponikowski P, Rasmussen HS, Lavin PT, Singh B, Yang A, Deedwania P. Maintenance of serum potassium with sodium zirconium cyclosilicate (ZS-9) in heart failure patients: results from a

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phase 3 randomized, double-blind, placebo-controlled trial. Eur J Heart Fail. 2015 May 23. doi: 10.1002/ejhf.300. [Epub ahead of print] PubMed PMID: 26011677.

M453) Palazzuoli A, Ruocco G, Ronco C, McCullough PA. Loop diuretics in acute heart failure:

beyond the decongestive relief for the kidney. Crit Care. 2015 Sep 3;19:296. doi: 10.1186/s13054-015-1017-3. PubMed PMID: 26335137; PubMed Central PMCID: PMC4559070.

M454) McCullough PA, Young A, Shutze WP. Acute Kidney Injury After Carotid Artery Stenting. JACC

Cardiovasc Interv. 2015 Sep;8(11):1515-7. doi: 10.1016/j.jcin.2015.07.006. PubMed PMID: 26404205.

M455) Fallahzadeh MK, McCullough PA. Cardiac Electromechanical Abnormalities in Hemodialysis

Patients: Indicators of Cardiomyopathy and Future Risk. Am J Nephrol. 2015;42(3):237-8. doi: 10.1159/000441100. Epub 2015 Oct 20. PubMed PMID: 26484657.

M456) Thompson-Martin Y, McCullough PA, Agrawal V. Impact of an Educational Program for

Advanced Practice Nurses on Knowledge of Kidney Disease Outcomes Quality Initiative Guidelines. Nephrol Nurs J. 2015 Sep-Oct;42(5):455-60, 496; quiz 461. PubMed PMID: 26591270.

M457) Larsen TR, Singh G, Velocci V, Nasser M, McCullough PA. Frequency of fluid overload and

usefulness of bioimpedance in patients requiring intensive care for sepsis syndromes. Proc (Bayl Univ Med Cent). 2016 Jan;29(1):12-5. PubMed PMID: 26722156; PubMed Central PMCID: PMC4677841.

M458) Charytan DM, Foley R, McCullough PA, Rogers JD, Zimetbaum P, Herzog CA, Tumlin JA; MiD

Investigators and Committees. Arrhythmia and Sudden Death in Hemodialysis Patients: Protocol and Baseline Characteristics of the Monitoring in Dialysis Study. Clin J Am Soc Nephrol. 2016 Jan 13. pii: CJN.09350915. [Epub ahead of print] PubMed PMID: 26763255.

M459) Roberts WC, Hall SA, Ko JM, McCullough PA, Lima B. Atrophy of the Heart After Insertion of

a Left Ventricular Assist Device and Closure of the Aortic Valve. Am J Cardiol. 2016 Mar 1;117(5):878-9. doi: 10.1016/j.amjcard.2015.12.008. Epub 2015 Dec 13. PubMed PMID: 26792135.

M460) Tecson KM, Silver MA, Brune SD, Cauthen C, Kwan MD, Schussler JM, Vasudevan A, Watts JA,

McCullough PA. Impact of Enhanced External Counterpulsation on Heart Failure Rehospitalization in Patients With Ischemic Cardiomyopathy. Am J Cardiol. 2015 Dec 31. pii: S0002-9149(15)30069-2. doi: 10.1016/j.amjcard.2015.12.024. [Epub ahead of print] PubMed PMID: 26813739.

M461) McCullough PA, Roberts WC. Influence of Chronic Renal Failure on Cardiac Structure. J Am

Coll Cardiol. 2016 Mar 15;67(10):1183-5. doi:10.1016/j.jacc.2015.11.065. PubMed PMID: 26965539.

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M462) Palazzuoli A, Ruocco G, Pellegrini M, Beltrami M, Giordano N, Nuti R, McCullough PA.

Prognostic Significance of Hyperuricemia in Patients With Acute Heart Failure. Am J Cardiol. 2016 May 15;117(10):1616-21. doi: 10.1016/j.amjcard.2016.02.039. Epub 2016 Mar 2. PubMed PMID: 27040576.

M463) McCullough PA, Fallahzadeh MK, Tecson KM. Predicting Acute Kidney Injury in the Catheterization Laboratory. J Am Coll Cardiol. 2016 Apr 12;67(14):1723-4. doi: 10.1016/j.jacc.2016.02.007. PubMed PMID: 27056779.

M464) Grodzinsky A, Goyal A, Gosch K, McCullough PA, Fonarow GC, Mebazaa A, Masoudi FA,

Spertus JA, Palmer BF, Kosiborod M. Prevalence and Prognosis of Hyperkalemia in Patients with Acute Myocardial Infarction. Am J Med. 2016 Apr 7. pii:S0002-9343(16)30317-5. doi: 10.1016/j.amjmed.2016.03.008. [Epub ahead of print] PubMed PMID: 27060233.

M465) Sherwood M, McCullough PA. Chronic kidney disease from screening, detection, and awareness, to prevention. Lancet Glob Health. 2016 May;4(5):e288-9. doi: 10.1016/S2214-109X(16)30049-3. PubMed PMID: 27102186.

M466) McCullough PA, Afzal A, Kale P. Goal-Directed Heart Failure Care in Patients With Chronic

Kidney Disease and End-Stage Renal Disease. JACC Heart Fail. 2016 May 30. pii: S2213-1779(16)30084-1. doi: 10.1016/j.jchf.2016.03.014. [Epub ahead of print] PubMed PMID: 27289405.

M467) Prasad A, Sohn A, Morales J, Williams K, Bailey SR, Levin D, McCullough PA, Mehran R,

Lopez-Cruz G, Harder J. Contemporary practice patterns related to the risk of acute kidney injury in the catheterization laboratory: Results from a survey of Society of Cardiovascular Angiography and Intervention (SCAI) cardiologists. Catheter Cardiovasc Interv. 2016 Jun 17. doi: 10.1002/ccd.26628. [Epub ahead of print] PubMed PMID: 27315581.

M468) Schussler JM, Vasudevan A, von Bose LJ, Won JI, McCullough PA. Comparative Efficacy of

Transradial Versus Transfemoral Approach for Coronary Angiography and Percutaneous Coronary Intervention. Am J Cardiol. 2016 Aug 15;118(4):482-8. doi: 10.1016/j.amjcard.2016.05.038. PubMed PMID: 27378143.

M469) Zannad F, Stough WG, Lipicky RJ, Tamargo J, Bakris GL, Borer JS, Alonso García Mde L,

Hadjadj S, Koenig W, Kupfer S, McCullough PA, Mosenzon O, Pocock S, Scheen AJ, Sourij H, Van der Schueren B, Stahre C, White WB, Calvo G. Assessment of cardiovascular risk of new drugs for the treatment of diabetes mellitus: risk assessment vs. risk aversion. Eur Heart J Cardiovasc Pharmacother. 2016 Jul;2(3):200-5. doi: 10.1093/ehjcvp/pvw007. Review. PubMed PMID: 27418973; PubMed Central PMCID: PMC4907355.

M470) McCullough PA, Bennett-Guerrero E, Chawla LS, Beaver T, Mehta RL, Molitoris BA, Eldred A,

Ball G, Lee HJ, Houser MT, Khan S. ABT-719 for the Prevention of Acute Kidney Injury in Patients

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Undergoing High-Risk Cardiac Surgery: A Randomized Phase 2b Clinical Trial. J Am Heart Assoc. 2016 Aug 20;5(8). pii:e003549. doi: 10.1161/JAHA.116.003549. PubMed PMID: 27543797; PubMed Central PMCID: PMC5015281.

M471) Brown JR, McCullough PA, Matheny ME. Novel Developments in Acute Kidney Injury.

Biomed Res Int. 2016;2016:2756204. doi: 10.1155/2016/2756204. PubMed PMID: 27595099; PubMed Central PMCID: PMC4995325.

M472) McCullough PA, Choi JP, Feghali GA, Schussler JM, Stoler RM, Vallabahn RC, Mehta A.

Contrast-Induced Acute Kidney Injury. J Am Coll Cardiol. 2016 Sep 27;68(13):1465-73. doi: 10.1016/j.jacc.2016.05.099. Review. PubMed PMID:27659469.

M473) Villa G, Neri M, Bellomo R, Cerda J, De Gaudio AR, De Rosa S, Garzotto F, Honore PM, Kellum

J, Lorenzin A, Payen D, Ricci Z, Samoni S, Vincent JL, Wendon J, Zaccaria M, Ronco C; Nomenclature Standardization Initiative (NSI) Alliance (McCullough PA member). Nomenclature for renal replacement therapy and blood purification techniques in critically ill patients: practical applications. Crit Care. 2016 Oct 10;20(1):283. Review. PubMed PMID: 27719676; PubMed Central PMCID: PMC5056485.

M474) McCullough PA, Fallahzadeh MK, Hegazi RM. Nutritional Deficiencies and Sarcopenia in

Heart Failure: A Therapeutic Opportunity to Reduce Hospitalization and Death. Rev Cardiovasc Med. 2016;17(S1):S30-S39. PubMed PMID: 27725625.

M475) Bakris GL, Burkart JM, Weinhandl ED, McCullough PA, Kraus MA. Intensive Hemodialysis,

Blood Pressure, and Antihypertensive Medication Use. Am J Kidney Dis. 2016 Nov;68(5S1):S15-S23. doi: 10.1053/j.ajkd.2016.05.026. PubMed PMID:27772639.

M476) Copland M, Komenda P, Weinhandl ED, McCullough PA, Morfin JA. Intensive Hemodialysis,

Mineral and Bone Disorder, and Phosphate Binder Use. Am J Kidney Dis. 2016 Nov;68(5S1):S24-S32. doi: 10.1053/j.ajkd.2016.05.024. PubMed PMID:27772640.

M477) Morfin JA, Fluck RJ, Weinhandl ED, Kansal S, McCullough PA, Komenda P. Intensive

Hemodialysis and Treatment Complications and Tolerability. Am J Kidney Dis. 2016 Nov;68(5S1):S43-S50. doi: 10.1053/j.ajkd.2016.05.021. PubMed PMID:27772642.

M478) McCullough PA, Chan CT, Weinhandl ED, Burkart JM, Bakris GL. Intensive Hemodialysis, Left

Ventricular Hypertrophy, and Cardiovascular Disease. Am J Kidney Dis. 2016 Nov;68(5S1):S5-S14. doi: 10.1053/j.ajkd.2016.05.025. PubMed PMID: 27772643.

M479) McCullough PA, Ball T, Cox KM, Assar MD. Use of Oral Anticoagulation in the Management

of Atrial Fibrillation in Patients with ESRD: Pro. Clin J Am Soc Nephrol. 2016 Nov 7;11(11):2079-2084. PubMed PMID: 27797888; PubMed Central PMCID: PMC5108189.

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M480) Zhang J, McCullough PA. Lipoic Acid in the Prevention of Acute Kidney Injury. Nephron. 2016;134(3):133-140. PubMed PMID: 27603173.

M481) McCullough PA, Vasudevan A, Lopez LR, Swift C, Peterson M, Bennett-Firmin J, Schiffmann R,

Bottiglieri T. Oxidative stress reflected by increased F(2)-isoprostanes is associated with increasing urinary 11-dehydro thromboxane B(2) levels in patients with coronary artery disease. Thromb Res. 2016 Oct 26;148:85-88. doi: 10.1016/j.thromres.2016.10.022. [Epub ahead of print] PubMed PMID: 27815971.

M482) Zhang J, Fallahzadeh MK, McCullough PA. Aging Male Spontaneously Hypertensive Rat as an

Animal Model for the Evaluation of the Interplay between Contrast-Induced Acute Kidney Injury and Cardiorenal Syndrome in Humans. Cardiorenal Med. 2016 Nov;7(1):1-10. Epub 2016 Jul 21. Review. PubMed PMID:27994597; PubMed Central PMCID: PMC5159736.

M483) Vasudevan A, Bottiglieri T, Tecson KM, Sathyamoorthy M, Schussler JM, Velasco CE, Lopez

LR, Swift C, Peterson M, Bennett-Firmin J, Schiffmann R, McCullough PA. Residual thromboxane activity and oxidative stress: influence on mortality in patients with stable coronary artery disease. Coron Artery Dis. 2017 Jun;28(4):287-293. doi: 10.1097/MCA.0000000000000461. PubMed PMID: 28005558.

M484) Krishnan DK, Pawlaczyk B, McCullough PA, Enright S, Kunadi A, Vanhecke TE. Point-of-Care,

Ultraportable Echocardiography Predicts Diuretic Response in Patients Admitted with Acute Decompensated Heart Failure. Clin Med Insights Cardiol. 2016 Dec 19;10:201-208. doi: 10.4137/CMC.S38896. eCollection 2016. PubMed PMID: 28008296; PubMed Central PMCID: PMC5170880.

M485) Singer AJ, Than MP, Smith S, McCullough P, Barrett TW, Birkhahn R, Reed M, Thode HC,

Arnold WD, Daniels LB, de Filippi C, Headden G, Peacock WF. Missed myocardial infarctions in ED patients prospectively categorized as low risk by established risk scores. Am J Emerg Med. 2017 Jan 5. pii: S0735-6757(17)30003-7. doi: 10.1016/j.ajem.2017.01.003. [Epub ahead of print] PubMed PMID: 28108220.

M486) Tecson KM, Arnold W, Barrett T, Birkhahn R, Daniels LB, DeFilippi C, Headden G, Peacock WF,

Reed M, Singer AJ, Schussler JM, Smith S, Than MP, McCullough PA. Interpretation of positive troponin results among patients with and without myocardial infarction. Proc (Bayl Univ Med Cent). 2017 Jan;30(1):11-15. PubMed PMID: 28127121; PubMed Central PMCID: PMC5242102.

M487) Tecson KM, Panettiere-Kennedy KS, Won JI, Garg P, Olugbode O, McCullough PA. Relation

between proprotein convertase subtilisin/kexin type 9 and directly measured low-density lipoprotein cholesterol. Proc (Bayl Univ Med Cent). 2017 Jan;30(1):16-20. PubMed PMID: 28127122; PubMed Central PMCID: PMC5242103.

M488) McCullough PA, Vasudevan A, Sathyamoorthy M, Schussler JM, Velasco CE, Lopez LR, Swift

C, Peterson M, Bennett-Firmin J, Schiffmann R, Bottiglieri T. Urinary 11-Dehydro-Thromboxane

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B(2) and Mortality in Patients With Stable Coronary Artery Disease. Am J Cardiol. 2017 Apr 1;119(7):972-977. doi: 10.1016/j.amjcard.2016.12.004. Epub 2017 Jan 5. PubMed PMID: 28139223

M489) Vasudevan A, Singer AJ, DeFilippi C, Headden G, Schussler JM, Daniels LB, Reed M, Than MP,

Birkhahn R, Smith SW, Barrett TW, Arnold W, Peacock WF, McCullough PA. Renal Function and Scaled Troponin in Patients Presenting to the Emergency Department with Symptoms of Myocardial Infarction. Am J Nephrol. 2017;45(4):304-309. doi: 10.1159/000458451. Epub 2017 Feb 14. PubMed PMID:28192777.

M490) McCullough PA, Zhang J, Ronco C. Volume expansion and contrast-induced acute kidney

injury. Lancet. 2017 Apr 1;389(10076):1277-1278. doi:10.1016/S0140-6736(17)30540-8. Epub 2017 Feb 21. PubMed PMID: 28236468.

M491) Elbehary S, Szerlip HM, McCullough PA. Potassium Excretion and Outcomes in CKD: Is K

Intake OK? Am J Kidney Dis. 2017 Mar;69(3):325-327. doi:10.1053/j.ajkd.2016.11.009. PubMed PMID: 28236878.

M492) McCullough PA, Rios A, Smith B. Dialysis fistulas and heart failure. Eur Heart J. 2017 Mar 17.

doi: 10.1093/eurheartj/ehx114. [Epub ahead of print] PubMed PMID:28329218.

M493) Howard CE, McCullough PA. Decoding Acute Myocardial Infarction among Patients on Dialysis. J Am Soc Nephrol. 2017 May;28(5):1337-1339. doi:10.1681/ASN.2017030226. Epub 2017 Apr 12. PubMed PMID: 28404663.

M494) Vasudevan A, Jazi HH, Won JI, Ball T, Patankar GR, Sarmast SA, Shin HJ, McCullough PA.

Personalized treatment of heart failure with biomarker guidance using a novel disease severity score. Proc (Bayl Univ Med Cent). 2017 Apr;30(2):139-142. PubMed PMID: 28405060; PubMed Central PMCID: PMC5349806.

M495) Won JI, Zhang J, Tecson KM, McCullough PA. Balancing Low-density Lipoprotein Cholesterol

Reduction and Hepatotoxicity With Lomitapide Mesylate and Mipomersen in Patients With Homozygous Familial Hypercholesterolemia. Rev Cardiovasc Med. 2017;18(1):21-28. PubMed PMID: 28509890.

M496) Afzal A, Sarmast S, Choi JW, McCullough PA, Schussler JM. Spontaneous Coronary Artery

Dissection: A Review of Pathogenesis, Presentations, Treatment, and Outcomes. Rev Cardiovasc Med. 2017;18(1):29-36. PubMed PMID: 28509891.

M497) McCullough PA. How Trialists and Pharmaceutical Sponsors Have Failed Us by Thinking That

Acute Heart Failure Is a 48-Hour Illness. Am J Cardiol. 2017 May 11. pii: S0002-9149(17)30795-6. doi: 10.1016/j.amjcard.2017.04.056. [Epub ahead of print] PubMed PMID: 28583677.

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M498) Zhang J, Bottiglieri T, McCullough PA. The Central Role of Endothelial Dysfunction in Cardiorenal Syndrome. Cardiorenal Med. 2017 Feb;7(2):104-117. doi: 10.1159/000452283. Epub 2016 Dec 29. Review. PubMed PMID: 28611784; PubMed Central PMCID: PMC5465690.

M499) Tecson KM, Erhardtsen E, Eriksen PM, Gaber AO, Germain M, Golestaneh L, Lavoria MLA,

Moore LW, McCullough PA. Optimal cut points of plasma and urine neutrophil gelatinase-associated lipocalin for the prediction of acute kidney injury among critically ill adults: retrospective determination and clinical validation of a prospective multicentre study. BMJ Open. 2017 Jul 10;7(7):e016028. doi: 10.1136/bmjopen-2017-016028. PubMed PMID: 28698338

M500) Vasudevan A, Schussler JM, Won JI, Ashcraft P, Bolanos I, Williams M, Bottiglieri T, Velasco

CE, McCullough PA. Urinary metabolites in patients undergoing coronary catheterization via the radial versus femoral artery approach. Proc (Bayl Univ Med Cent). 2017 Oct;30(4):404-409. PubMed PMID: 28966445; PubMed Central PMCID: PMC5595375.

M501) Azzalini L, Candilio L, McCullough PA, Colombo A. Current Risk of Contrast-Induced Acute

Kidney Injury After Coronary Angiography and Intervention: A Reappraisal of the Literature. Can J Cardiol. 2017 Oct;33(10):1225-1228. doi: 10.1016/j.cjca.2017.07.482. Epub 2017 Aug 3. Review. PubMed PMID: 28941604.

M502) Palazzuoli A, Ruocco G, De Vivo O, Nuti R, McCullough PA. Prevalence of Hyperuricemia in

Patients With Acute Heart Failure With Either Reduced or Preserved Ejection Fraction. Am J Cardiol. 2017 Oct 1;120(7):1146-1150. doi: 10.1016/j.amjcard.2017.06.057. Epub 2017 Jul 17. PubMed PMID: 28807403.

M503) Kovesdy CP, Appel LJ, Grams ME, Gutekunst L, McCullough PA, Palmer BF, Pitt B, Sica DA,

Townsend RR. Potassium homeostasis in health and disease: A scientific workshop cosponsored by the National Kidney Foundation and the American Society of Hypertension. J Am Soc Hypertens. 2017 Oct 10. pii: S1933-1711(17)30337-6. doi: 10.1016/j.jash.2017.09.011. [Epub ahead of print] PubMed PMID: 29030153.

M504) Afzal A, Vallabhan RC, McCullough PA. Acute kidney injury in cardiogenic shock: in search of

early detection and clinical certainty. Eur J Heart Fail. 2017 Oct 12. doi: 10.1002/ejhf.1032. [Epub ahead of print] PubMed PMID: 29027337.

M505) Ronco C, Ronco F, McCullough PA. A Call to Action to Develop Integrated Curricula in

Cardiorenal Medicine. Blood Purif. 2017 Oct 25;44(4):251-259. doi: 10.1159/000480318. [Epub ahead of print] PubMed PMID: 29065398.

M506) Ronco C, Ronco F, McCullough PA. A Call to Action to Develop Integrated Curricula in

Cardiorenal Medicine. Rev Cardiovasc Med. 2017;18(3):93-99. PubMed PMID: 29111542.

M507) Butler J, Hamo CE, Filippatos G, Pocock SJ, Bernstein RA, Brueckmann M, Cheung AK, George JT, Green JB, Januzzi JL, Kaul S, Lam CSP, Lip GYH, Marx N, McCullough PA, Mehta CR,

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Ponikowski P, Rosenstock J, Sattar N, Salsali A, Scirica BM, Shah SJ, Tsutsui H, Verma S, Wanner C, Woerle HJ, Zannad F, Anker SD; EMPEROR Trials Program. The potential role and rationale for treatment of heart failure with sodium-glucose co-transporter 2 inhibitors. Eur J Heart Fail. 2017 Nov;19(11):1390-1400. doi: 10.1002/ejhf.933. Epub 2017 Aug 24. Review. PubMed PMID: 28836359.

M508) McCullough PA, David G, Todoran TM, Brilakis ES, Ryan MP, Gunnarsson C. Iso-osmolar

contrast media and adverse renal and cardiac events after percutaneous cardiovascular intervention. J Comp Eff Res. 2017 Nov 9. doi: 10.2217/cer-2017-0052. [Epub ahead of print] PubMed PMID: 29117715.

M509) Rocha NA, East C, Zhang J, McCullough PA. ApoCIII as a Cardiovascular Risk Factor and

Modulation by the Novel Lipid-Lowering Agent Volanesorsen. Curr Atheroscler Rep. 2017 Nov 9;19(12):62. doi: 10.1007/s11883-017-0697-3. Review. PubMed PMID: 29124482.

M510) Rangaswami J, Mathew RO, McCullough PA. Resuscitation for the specialty of nephrology: is

cardionephrology the answer? Kidney Int. 2017 Nov 11. pii: S0085-2538(17)30727-5. doi: 10.1016/j.kint.2017.10.002. [Epub ahead of print] PubMed PMID: 29137816.

M511) Kovesdy CP, Appel LJ, Grams ME, Gutekunst L, McCullough PA, Palmer BF, Pitt B, Sica DA,

Townsend RR. Potassium Homeostasis in Health and Disease: A Scientific Workshop Cosponsored by the National Kidney Foundation and the American Society of Hypertension. Am J Kidney Dis. 2017 Dec;70(6):844-858. doi: 10.1053/j.ajkd.2017.09.003. Epub 2017 Oct 10. PubMed PMID: 29029808.

M512) Ostermann M, McCullough PA, Forni LG, Bagshaw SM, Joannidis M, Shi J, Kashani K, Honore

PM, Chawla LS, Kellum JA; all SAPPHIRE Investigators. Kinetics of Urinary Cell Cycle Arrest Markers for Acute Kidney Injury Following Exposure to Potential Renal Insults. Crit Care Med. 2017 Nov 20. doi:10.1097/CCM.0000000000002847. [Epub ahead of print] PubMed PMID: 29189343

M513) Vasudevan A, Tecson KM, Bennett-Firmin J, Bottiglieri T, Lopez LR, Peterson M,

Sathyamoorthy M, Schiffmann R, Schussler JM, Swift C, Velasco CE, McCullough PA. Prognostic value of urinary 11-dehydro-thromboxane B(2) for mortality: A cohort study of stable coronary artery disease patients treated with aspirin. Catheter Cardiovasc Interv. 2017 Nov 29. doi: 10.1002/ccd.27437. [Epub ahead of print] PubMed PMID: 29193683.

M514) Himmelfarb J, Chertow GM, McCullough PA, Mesana T, Shaw AD, Sundt TM, Brown C,

Cortville D, Dagenais F, de Varennes B, Fontes M, Rossert J, Tardif JC. Perioperative THR-184 and AKI after Cardiac Surgery. J Am Soc Nephrol. 2017 Dec 4. pii: ASN.2017020217. doi: 10.1681/ASN.2017020217. [Epub ahead of print] PubMed PMID: 29203473.

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M515) McCullough PA, Rangaswami J. Real or Perceived: Hyperkalemia Is a Major Deterrent for Renin-Angiotensin Aldosterone System Inhibition in Heart Failure. Nephron. 2017 Dec 5. doi: 10.1159/000485645. [Epub ahead of print] PubMed PMID: 29207385.

M516) Keuffel E, McCullough PA, Todoran TM, Brilakis ES, Palli SR, Ryan MP, Gunnarsson C. The

effect of major adverse renal cardiovascular event (MARCE) incidence, procedure volume, and unit cost on the hospital savings resulting from contrast media use in inpatient angioplasty. J Med Econ. 2017 Dec 15:1-9. doi: 10.1080/13696998.2017.1415912. [Epub ahead of print] PubMed PMID: 29226736.

M517) Tecson KM, Brown D, Choi JW, Feghali G, Gonzalez-Stawinski GV, Hamman BL, Hebeler R,

Lander SR, Lima B, Potluri S, Schussler JM, Stoler RC, Velasco C, McCullough PA. Major Adverse Renal and Cardiac Events After Coronary Angiography and Cardiac Surgery. Ann Thorac Surg. 2018 Jun;105(6):1724-1730. doi:10.1016/j.athoracsur.2018.01.010. Epub 2018 Feb 2. PubMed PMID: 29408241.

M518) Haase VH, Chertow GM, Block GA, Pergola PE, deGoma EM, Khawaja Z, Sharma A, Maroni BJ,

McCullough PA. Effects of vadadustat on hemoglobin concentrations in patients receiving hemodialysis previously treated with erythropoiesis-stimulating agents. Nephrol Dial Transplant. 2018 Apr 16. doi: 10.1093/ndt/gfy055. [Epub ahead of print] PubMed PMID: 29672740.

M519) McCullough PA, Ballantyne CM, Sanganalmath SK, Langslet G, Baum SJ, Shah PK, Koren A,

Mandel J, Davidson MH. Efficacy and Safety of Alirocumab in High-Risk Patients With Clinical Atherosclerotic Cardiovascular Disease and/or Heterozygous Familial Hypercholesterolemia (from 5 Placebo-Controlled ODYSSEY Trials). Am J Cardiol. 2018 Apr 15;121(8):940-948. doi: 10.1016/j.amjcard.2017.12.040. Epub 2018 Feb 2. PubMed PMID: 29472008.

M520) Zhang J, Tecson KM, Rocha NA, McCullough PA. Usefulness of alirocumab and evolocumab

for the treatment of patients with diabetic dyslipidemia. Proc (Bayl Univ Med Cent). 2018 Apr 11;31(2):180-184. doi: 10.1080/08998280.2018.1441255. eCollection 2018 Apr. Review. PubMed PMID: 29706812; PubMed Central PMCID: PMC5914471.

M521) McCullough PA. Editorial: Robertsonian Perspectives on Atherosclerosis: The Power of Direct

Observation. Am J Cardiol. 2018 Apr 3. pii: S0002-9149(18)30255-8. doi: 10.1016/j.amjcard.2018.02.019. [Epub ahead of print] PubMed PMID: 29724407.

M522) Maisel AS, Daniels LB, Anand IS, McCullough PA, Chow SL. Utility of natriuretic peptides to

assess and manage patients with heart failure receiving angiotensin receptor blocker/neprilysin inhibitor therapy. Postgrad Med. 2018 Apr;130(3):299-307. doi: 10.1080/00325481.2018.1440873. Epub 2018 Mar 29. Review. PubMed PMID: 29596012.

M523) McCullough PA, Kluger AY. Interpreting the Wide Range of NT-proBNP Concentrations in

Clinical Decision Making. J Am Coll Cardiol. 2018 Mar 20;71(11):1201-1203. doi: 10.1016/j.jacc.2018.01.056. PubMed PMID: 29544602.

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M524) Turakhia MP, Blankestijn PJ, Carrero JJ, Clase CM, Deo R, Herzog CA, Kasner SE, Passman RS,

Pecoits-Filho R, Reinecke H, Shroff GR, Zareba W, Cheung M, Wheeler DC, Winkelmayer WC, Wanner C; Conference Participants (McCullough PA) . Chronic kidney disease and arrhythmias: conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference. Eur Heart J. 2018 Mar 7. doi:10.1093/eurheartj/ehy060. [Epub ahead of print] PubMed PMID: 29522134.

M525) Cherney DZI, Lytvyn Y, McCullough PA. Cardiovascular Risk Reduction in Patients With

Chronic Kidney Disease: Potential for Targeting Inflammation With Canakinumab. J Am Coll Cardiol. 2018 May 29;71(21):2415-2418. doi:10.1016/j.jacc.2018.04.008. PubMed PMID: 29793630.

M526) Barbin CM, Vasudevan A, Choi JW, McCullough PA, Schussler JM, Vallabhan RC, Stoler RC.

Frequency of abnormal fractional flow reserve measurements among major coronary arteries. Cardiovasc Revasc Med. 2018 Apr 25. pii: S1553-8389(18)30145-3. doi: 10.1016/j.carrev.2018.04.015. [Epub ahead of print] PubMed PMID: 29807815.

M527) Vasudevan A, Hundae A, Borodge D, McCullough PA, Wells PJ. Frequency of atrial

arrhythmias after atrial flutter ablation and the effect of presenting rhythm on the day of ablation. Proc (Bayl Univ Med Cent). 2018 May 14;31(3):280-283. doi: 10.1080/08998280.2018.1464305. eCollection 2018 Jul. PubMed PMID: 29904288;PubMed Central PMCID: PMC5997080.

M528) Rengarajan R, McCullough PA, Chowdhury A, Tecson KM. Identifying suspected familial

chylomicronemia syndrome. Proc (Bayl Univ Med Cent). 2018 May 21;31(3):284-288. doi: 10.1080/08998280.2018.1463784. eCollection 2018 Jul. PubMed PMID: 29904289; PubMed Central PMCID: PMC5997083.

M529) Maioli M, Toso A, Leoncini M, Musilli N, Grippo G, Ronco C, McCullough PA, Bellandi F.

Bioimpedance-Guided Hydration for the Prevention of Contrast-Induced Kidney Injury: The HYDRA Study. J Am Coll Cardiol. 2018 Jun 26;71(25):2880-2889. doi: 10.1016/j.jacc.2018.04.022. PubMed PMID: 29929610.

M530) McCullough PA, Uhlig K, Neylan JF, Pergola PE, Fishbane S. Usefulness of Oral Ferric Citrate

in Patients With Iron-Deficiency Anemia and Chronic Kidney Disease With or Without Heart Failure. Am J Cardiol. 2018 Aug 15;122(4):683-688. doi: 10.1016/j.amjcard.2018.04.062. Epub 2018 May 19. PubMed PMID: 29961562.

M531) de Albuquerque Rocha N, Neeland IJ, McCullough PA, Toto RD, McGuire DK. Effects of

sodium glucose co-transporter 2 inhibitors on the kidney. Diab Vasc Dis Res. 2018 Sep;15(5):375-386. doi: 10.1177/1479164118783756. Epub 2018 Jul 2. Review. PubMed PMID: 29963920.

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M532) Chaudhry RI, Mathew RO, Sidhu MS, Sidhu-Adler P, Lyubarova R, Rangaswami J, Salman L, Asif A, Fleg JL, McCullough PA, Maddux F, Bangalore S. Detection of Atherosclerotic Cardiovascular Disease in Patients with Advanced Chronic Kidney Disease in the Cardiology and Nephrology Communities. Cardiorenal Med. 2018;8(4):285-295. doi: 10.1159/000490768. Epub 2018 Aug 3. PubMed PMID:30078001.

M533) Kazory A, McCullough PA, Rangaswami J, Ronco C. Cardionephrology: Proposal for a

Futuristic Educational Approach to a Contemporary Need. Cardiorenal Med. 2018;8(4):296-301. doi: 10.1159/000490744. Epub 2018 Aug 8. Review. PubMed PMID: 30089281.

M534) Kluger AY, McCullough PA. Semaglutide and GLP-1 analogues as weight-loss agents. Lancet.

2018 Aug 25;392(10148):615-616. doi: 10.1016/S0140-6736(18)31826-9. Epub 2018 Aug 16. PubMed PMID: 30122306.

M535) Ambrosy AP, Mulder H, Coles A, Krauss WE, Lam CSP, McCullough PA, Pina I, Tromp J,

Whellan DJ, O'Connor CM, Mentz RJ. Renal Function and Exercise Training in AmbulatoryHeart Failure Patients With a Reduced Ejection Fraction. Am J Cardiol. 2018 Sep 15;122(6):999-1007. doi: 10.1016/j.amjcard.2018.06.011. Epub 2018 Jun 23. PubMed PMID: 30269900.

M536) McCullough PA, Todoran TM, Brilakis ES, Ryan MP, Gunnarsson C. Rate of major adverse

renal or cardiac events with iohexol compared to other low osmolar contrast media during interventional cardiovascular procedures. Catheter Cardiovasc Interv. 2018 Oct 2. doi: 10.1002/ccd.27807. [Epub ahead of print] PubMed PMID: 30280476.

M537) McCullough PA, Soman S. Cardiorenal Syndrome: A Call to Action for a Pressing Medical

Issue. Adv Chronic Kidney Dis. 2018 Sep;25(5):379-381. doi: 10.1053/j.ackd.2018.08.011. PubMed PMID: 30309454.

M538) Rangaswami J, McCullough PA. Heart Failure in End-Stage Kidney Disease: Pathophysiology,

Diagnosis, and Therapeutic Strategies. Semin Nephrol. 2018 Nov;38(6):600-617. doi: 10.1016/j.semnephrol.2018.08.005. Review. PubMed PMID: 30413254.

M539) Goyal A, Chatterjee K, Mathew RO, Sidhu MS, Bangalore S, McCullough PA, Rangaswami J.

In-Hospital Mortality and Major Adverse Cardiovascular Events after Kidney Transplantation in the United States. Cardiorenal Med. 2018 Nov 14;9(1):51-60. doi: 10.1159/000492731. [Epub ahead of print] PubMed PMID: 30428461.

M540) McCullough PA. Treatment of Orthostatic Hypotension Due to Autonomic Dysfunction

(Neurogenic Orthostatic Hypotension) in a Patient with Cardiovascular Disease and Parkinson's Disease. Cardiol Ther. 2019 Jun;8(1):145-150. Doi: 10.1007/s40119-018-0124-z. Epub 2019 Jan 9. PubMed PMID: 30627953.

M541) Vasudevan A, Choi JW, Feghali GA, Lander SR, Jialiang L, Schussler JM, Stoler RC, Vallabhan

RC, Velasco CE, McCullough PA. Event dependence in the analysis of cardiovascular

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readmissions postpercutaneous coronary intervention. J Investig Med. 2019 Jan 18. pii: jim-2018-000873. doi: 10.1136/jim-2018-000873. [Epub ahead of print] PubMed PMID: 30659091.

M542) Rocha NA, McCullough PA. Cardiovascular outcomes in diabetic kidney disease: insights

from recent clinical trials. Kidney Int Suppl (2011). 2018 Jan;8(1):8-17. doi: 10.1016/j.kisu.2017.10.004. Epub 2017 Dec 29. Review. PubMed PMID: 30675434; PubMed Central PMCID: PMC6336216.

M543) Rangaswami J, Bhalla V, Blair JEA, Chang TI, Costa S, Lentine KL, Lerma EV, Mezue K, Molitch

M, Mullens W, Ronco C, Tang WHW, McCullough PA; American Heart Association Council on the Kidney in Cardiovascular Disease and Council on Clinical Cardiology. Cardiorenal Syndrome: Classification, Pathophysiology, Diagnosis, and Treatment Strategies: A Scientific Statement From the American Heart Association. Circulation. 2019 Apr 16;139(16):e840-e878. doi: 10.1161/CIR.0000000000000664. PubMed PMID: 30852913.

M544) Ball TN, Vasudevan A, Mi Ko J, Assar MD, McCullough PA, Stoler RC. Analysis of

electrocardiographic intervals before and after transcatheter aortic valve implantation to predict the need for permanent pacing. Proc (Bayl Univ Med Cent). 2018 Sep 11;31(4):407-413. doi: 10.1080/08998280.2018.1471884. eCollection 2018 Oct. PubMed PMID: 30948968; PubMed Central PMCID: PMC6413979.

M545) Brown K, Adams J, McCullough PA. Comparison of reflex, resistance training, and core

activities using change in blood pressure over time after spontaneous coronary artery dissection. Proc (Bayl Univ Med Cent). 2019 Jan 14;32(1):113-115. doi: 10.1080/08998280.2018.1533308. eCollection 2019 Jan. PubMed PMID: 30956602; PubMed Central PMCID: PMC6442865.

M546) Sudhakaran S, McCullough PA. Common laboratory parameters as indicators of multi-organ

dysfunction in acute heart failure. Eur J Heart Fail. 2019 Apr 11. doi: 10.1002/ejhf.1466. [Epub ahead of print] PubMed PMID: 30972928.

M547) Rangaswami J, Mathew RO, Parasuraman R, Tantisattamo E, Lubetzky M, Rao S, Yaqub MS,

Birdwell KA, Bennett W, Dalal P, Kapoor R, Lerma EV, Lerman M, McCormick N, Bangalore S, McCullough PA, Dadhania DM. Cardiovascular disease in the kidney transplant recipient: epidemiology, diagnosis and management strategies. Nephrol Dial Transplant. 2019 May 1;34(5):760-773. doi: 10.1093/ndt/gfz053. PubMed PMID: 30984976.

M548) Rangaswami J, Soman S, McCullough PA. Key Updates in Cardio-Nephrology from 2018:

Springboard to a Bright Future. Cardiorenal Med. 2019 Apr 17;9(4):222-228. doi: 10.1159/000498916. [Epub ahead of print] PubMed PMID: 30995636.

M549) Zhang J, Rocha NA, McCullough PA. Contribution of ApoCIII to Diabetic Dyslipidemia and

Treatment With Volanesorsen. Rev Cardiovasc Med. 2018 Mar 30;19(1):13-19. doi: 10.31083/j.rcm.2018.01.890. PubMed PMID: 31032598.

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M550) Tumlin JA, Roy-Chaudhury P, Koplan BA, Costea AI, Kher V, Williamson D, Pokhariyal S,

Charytan DM; MiD investigators and Committees (McCullough PA) . Relationship between dialytic parameters and reviewer confirmed arrhythmias in hemodialysis patients in the monitoring in dialysis study. BMC Nephrol. 2019 Mar 5;20(1):80. doi: 10.1186/s12882-019-1212-6. PubMed PMID: 30836948; PubMed Central PMCID: PMC6402171.

M551) Kluger AY, Tecson KM, Barbin CM, Lee AY, Lerma EV, Rosol ZP, Rangaswami J, Lepor NE,

Cobble ME, McCullough PA. Cardiorenal Outcomes in the CANVAS, DECLARE-TIMI 58, and EMPA-REG OUTCOME Trials: A Systematic Review. Rev Cardiovasc Med. 2018 Jun 30;19(2):41-49. doi: 10.31083/j.rcm.2018.02.907. PubMed PMID: 31032602.

M552) McCullough PA, Kluger AY, Tecson KM, Barbin CM, Lee AY, Lerma EV, Rosol ZP, Kluger SL,

Rangaswami J. Inhibition of the Sodium-Proton Antiporter (Exchanger) is a Plausible Mechanism of Potential Benefit and Harm for Drugs Designed to Block Sodium Glucose Co-transporter 2. Rev Cardiovasc Med. 2018 Jun 30;19(2):51-63. doi: 10.31083/j.rcm.2018.02.021. PubMed PMID: 31032603.

M553) Zanoli L, Lentini P, Briet M, Castellino P, House AA, London GM, Malatino L, McCullough PA,

Mikhailidis DP, Boutouyrie P. Arterial Stiffness in the Heart Disease of CKD. J Am Soc Nephrol. 2019 Apr 30. pii: ASN.2019020117. doi: 10.1681/ASN.2019020117. [Epub ahead of print] PubMed PMID: 31040188.

M554) House AA, Wanner C, Sarnak MJ, Piña IL, McIntyre CW, Komenda P, Kasiske BL, Deswal A,

deFilippi CR, Cleland JGF, Anker SD, Herzog CA, Cheung M, Wheeler DC, Winkelmayer WC, McCullough PA; Conference Participants. Heart failure in chronic kidney disease: conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference. Kidney Int. 2019 Apr 30. pii: S0085-2538(19)30276-5. doi: 10.1016/j.kint.2019.02.022. [Epub ahead of print] PubMed PMID: 31053387.

M555) Sudhakaran S, Bottiglieri T, Tecson KM, Kluger AY, McCullough PA. Alteration of lipid

metabolism in chronic kidney disease, the role of novel antihyperlipidemic agents, and future directions. Rev Cardiovasc Med. 2018 Sep 30;19(3):77-88. doi: 10.31083/j.rcm.2018.03.908. PubMed PMID: 31054556.

M556) Rangaswami J, Soman S, McCullough PA. Key updates in Cardio-Nephrology from 2018:

springboard to a bright Future. Rev Cardiovasc Med. 2018 Dec 30;19(4):113-116. doi: 10.31083/j.rcm.2018.04.896. PubMed PMID: 31064161.

M557) Tecson KM, Hashemi H, Afzal A, Gong TA, Kale P, McCullough PA. Community-Acquired

Acute Kidney Injury as a Risk Factor of de novo Heart Failure Hospitalization. Cardiorenal Med. 2019 May 10;9(4):252-260. doi: 10.1159/000499669. [Epub ahead of print] PubMed PMID: 31079099.

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M558) Tumlin JA, Roy-Chaudhury P, Koplan BA, Costea AI, Kher V, Williamson D, Pokhariyal S, Charytan DM; MiD investigators and Committees (McCullough PA). Relationship between dialytic parameters and reviewer confirmed arrhythmias in hemodialysis patients in the monitoring in dialysis study. BMC Nephrol. 2019 Mar 5;20(1):80. doi:10.1186/s12882-019-1212-6. PubMed PMID: 30836948; PubMed Central PMCID:PMC6402171.

M559) Vijayaraghavan K, McCullough PA, Singh B, Gupta M, Enas E, Mohan V, Misra A, Deedwania

P, Brinton EA; for the Consensus Panel Steering Committee . Cardiometabolic-Renal Disease in South Asians: Consensus Recommendations from the Cardio Renal Society of America. Cardiorenal Med. 2019 May 10;9(4):240-251. doi: 10.1159/000499341. [Epub ahead of print] PubMed PMID: 31079117.

M560) McCullough PA, Mehta HS, Cork DP, Barker CM, Gunnarsson C, Mollenkopf S, Van Houten J,

Verta P. The healthcare burden of disease progression in Medicare patients with functional mitral regurgitation. J Med Econ. 2019 May 20:1. doi: 10.1080/13696998.2019.1621325. [Epub ahead of print] PubMed PMID: 31104524.

M561) Spinowitz BS, Fishbane S, Pergola PE, Roger SD, Lerma EV, Butler J, von Haehling S, Adler SH,

Zhao J, Singh B, Lavin PT, McCullough PA, Kosiborod M, Packham DK; ZS-005 Study Investigators. Sodium Zirconium Cyclosilicate among Individuals with Hyperkalemia: A 12-Month Phase 3 Study. Clin J Am Soc Nephrol. 2019 May 20. pii: CJN.12651018. doi: 10.2215/CJN.12651018. [Epub ahead of print] PubMed PMID: 31110051.

M562) Rangaswami J, McCullough PA. Clinical Context of Dyskalemias Across the Heart Failure

Spectrum and Their Associated Adverse Outcomes. JACC Heart Fail. 2019 Jun;7(6):533. doi: 10.1016/j.jchf.2019.01.005. PubMed PMID: 31146878.

M563) Ahmad FS, Kallen MA, Schifferdecker KE, Carluzzo KL, Yount SE, Gelow JM, McCullough PA,

Kimmel SE, Fisher ES, Cella D. Development and Initial Validation of the PROMIS®-Plus-HF Profile Measure. Circ Heart Fail. 2019 Jun;12(6):e005751. doi: 10.1161/CIRCHEARTFAILURE.118.005751. Epub 2019 Jun 5. PubMed PMID: 31163985; PubMed Central PMCID: PMC6711378.

M564) Rizk DV, Silva AL, Pergola PE, Toto R, Warnock DG, Chin MP, Goldsberry A, O'Grady M, Meyer

CJ, McCullough PA. Effects of Bardoxolone Methyl on Magnesium in Patients with Type 2 Diabetes Mellitus and Chronic Kidney Disease. Cardiorenal Med. 2019;9(5):316-325. doi: 10.1159/000500612. Epub 2019 Jun 6. PubMed PMID: 31170712.

M565) Vasudevan A, Choi JW, Feghali GA, Kluger AY, Lander SR, Tecson KM, Sathyamoorthy M,

Schussler JM, Stoler RC, Vallabhan RC, Velasco CE, Yoon A, McCullough PA. First and recurrent events after percutaneous coronary intervention: implications for survival analyses. Scand Cardiovasc J. 2019 Jul 25:1-6. doi: 10.1080/14017431.2019.1645349. [Epub ahead of print] PubMed PMID: 31315473.

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M566) Cedars A, Tecson KM, Zaidi AN, Lorts A, McCullough PA. Impact of Durable Ventricular Assist Device Support on Outcomes of Patients with Congenital Heart Disease Waiting for Heart Transplant. ASAIO J. 2019 Jul 15. doi:10.1097/MAT.0000000000001041. [Epub ahead of print] PubMed PMID: 31335373.

M567) Rangaswami J, Bangalore S, Kaplan B, Birdwell KA, Wiseman AC, McCullough PA, Dadhania

DM. Cardiovascular disease care fragmentation in kidney transplantation: a call for action. Kidney Int. 2019 Sep;96(3):568-571. doi: 10.1016/j.kint.2019.04.042. Epub 2019 Jun 10. PubMed PMID: 31349974.

M568) Rossing P, Block GA, Chin MP, Goldsberry A, Heerspink HJL, McCullough PA, Meyer CJ,

Packham D, Pergola PE, Spinowitz B, Sprague SM, Warnock DG, Chertow GM. Effect of bardoxolone methyl on the urine albumin-to-creatinine ratio in patients with type 2 diabetes and stage 4 chronic kidney disease. Kidney Int. 2019 May 16. pii: S0085-2538(19)30503-4. doi: 10.1016/j.kint.2019.04.027. [Epub ahead of print] PubMed PMID: 31377056.

M569) Kluger AY, Tecson KM, Lee AY, Lerma EV, Rangaswami J, Lepor NE, Cobble ME, McCullough

PA. Class effects of SGLT2 inhibitors on cardiorenal outcomes. Cardiovasc Diabetol. 2019 Aug 5;18(1):99. doi: 10.1186/s12933-019-0903-4. Review. PubMed PMID: 31382965; PubMed Central PMCID: PMC6683461.

M570) McCullough PA, Mehta HS, Barker CM, Cork DP, Gunnarsson C, Ryan MP, Baker ER, Van

Houten J, Mollenkopf S, Verta P. The Economic Impact of Mitral Regurgitation on Patients With Medically Managed Heart Failure. Am J Cardiol. 2019 Oct 15;124(8):1226-1231. doi: 10.1016/j.amjcard.2019.07.033. Epub 2019 Jul 30. PubMed PMID: 31470974.

M571) Singhania G, Ejaz AA, McCullough PA, Kluger AY, Balamuthusamy S, Dass B, Singhania N,

Agarwal A. Continuation of Chronic Heart Failure Therapies During Heart Failure Hospitalization - a Review. Rev Cardiovasc Med. 2019 Sep 30;20(3):111-120. doi: 10.31083/j.rcm.2019.03.562. Review. PubMed PMID: 31601085.

M572) McCullough PA, Ostermann M, Forni LG, Bihorac A, Koyner JL, Chawla LS, Shi J, Kampf JP,

McPherson P, Kellum JA; the Sapphire Investigators. Serial Urinary Tissue Inhibitor of Metalloproteinase-2 and Insulin-Like Growth Factor-Binding Protein 7 and the Prognosis for Acute Kidney Injury over the Course of Critical Illness. Cardiorenal Med. 2019;9(6):358-369. doi: 10.1159/000502837. Epub 2019 Oct 16. PubMed PMID: 31618746.

M573) Husain-Syed F, Birk HW, Ronco C, Schörmann T, Tello K, Richter MJ, Wilhelm J, Sommer N,

Steyerberg E, Bauer P, Walmrath HD, Seeger W, McCullough PA, Gall H, Ghofrani HA. Doppler-Derived Renal Venous Stasis Index in the Prognosis of Right Heart Failure. J Am Heart Assoc. 2019 Nov 5;8(21):e013584. doi: 10.1161/JAHA.119.013584. Epub 2019 Oct 19. PubMed PMID: 31630601; PubMed Central PMCID: PMC6898799.

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M574) Haq A, McCullough PA. The Promise of next generation sequencing micro RNA for the discovery of new targets in contrast induced acute kidney injury. Ann Transl Med. 2019 Sep;7(18):424. doi: 10.21037/atm.2019.07.83. PubMed PMID: 31700860; PubMed Central PMCID: PMC6803241.

M575) Lo KB, Gul F, Ram P, Kluger AY, Tecson KM, McCullough PA, Rangaswami J. The Effects of

SGLT2 Inhibitors on Cardiovascular and Renal Outcomes in Diabetic Patients: A Systematic Review and Meta-Analysis. Cardiorenal Med. 2020;10(1):1-10. doi: 10.1159/000503919. Epub 2019 Nov 19. PubMed PMID: 31743918.

M576) Raju B, McCullough PA. Circulating plasma dipeptidyl dipeptidase 3 and the prognosis of

cardiogenic shock. Eur J Heart Fail. 2020 Feb;22(2):287-289. doi:10.1002/ejhf.1623. Epub 2019 Nov 28. PubMed PMID: 31779037.

M577) Husain-Syed F, Birk HW, Tello K, Richter MJ, Ronco C, McCullough PA, Schörmann T, Ferrari

F, Yücel G, Yazdani B, Walmrath HD, Seeger W, Gall H, Ghofrani HA. Alterations in Doppler-derived renal venous stasis index during decompensation of right heart failure and fluid overload in a patient with pulmonary hypertension. Rev Cardiovasc Med. 2019 Dec 30;20(4):263-266. doi: 10.31083/j.rcm.2019.04.564. PubMed PMID: 31912717.

M578) Weir MR, McCullough PA, Buse JB, Anderson J. Renal and Cardiovascular Effects of Sodium

Glucose Co-Transporter 2 Inhibitors in Patients with Type 2 Diabetes and Chronic Kidney Disease: Perspectives on the Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation Trial Results. Am J Nephrol. 2020;51(4):276-288. doi: 10.1159/000506533. Epub 2020 Mar 13. PMID: 32172239.

M579) Cork DP, McCullough PA, Mehta HS, Barker CM, Van Houten J, Gunnarsson C, Ryan MP,

Baker ER, Mollenkopf S, Verta P. The economic impact of clinically significant tricuspid regurgitation in a large, administrative claims database. J Med Econ. 2020 Mar 2:1-8. doi: 10.1080/13696998.2020.1718681. [Epub ahead of print] PubMed PMID: 31952454.

M580) Xu MX, Teng RL, Ruddy TD, Schoenhagen P, Bartel T, Di Bartolomeo R, Aksoy O, Desai M, von

Kodolitsch Y, Escaned J, McCullough PA, Vasudevan A, Shen CX, Zhao X, Zhou YF, Xu HF, Cheng XJ, He YM; written on behalf of the AME Interventional Cardiology Collaborative Group. The CatLet score: a new coronary angiographic scoring tool accommodating the variable coronary anatomy for the first time. J Thorac Dis. 2019 Dec;11(12):5199-5209. doi: 10.21037/jtd.2019.12.18. PubMed PMID: 32030237; PubMed Central PMCID: PMC6988012.

M581) Gopalakrishnan A, Mossaid A, Lo KB, Vasudevan V, McCullough PA, Rangaswami J. Fulminant

Acute Kidney Injury in a Young Patient with Novel Coronavirus 2019. Cardiorenal Med. 2020;10(4):217-222. doi: 10.1159/000508179. Epub 2020 May 6. PMID: 32375150; PMCID: PMC7251584.

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M582) McCullough PA. Prevention Guidelines as Failed Minimal Standards of Care. Am J Cardiol. 2020 May 1;125(9):1441-1442. doi: 10.1016/j.amjcard.2020.02.001. Epub 2020 Feb 13. PMID: 32145899.

M583) Rosol ZP, Kopecky KF, Minehart BR, Tecson KM, Vasudevan A, McCullough PA, Grayburn PA,

Schussler JM. Limitations of transoesophageal echocardiogram in acute ischaemic stroke. Open Heart. 2020 Mar 24;7(1):e001176. doi: 10.1136/openhrt-2019-001176. PMID: 32257245; PMCID: PMC7103838.

M584) Lo KB, McCullough PA, Rangaswami J. Antihypertensive drugs and risk of COVID-19? Lancet

Respir Med. 2020 May;8(5):e29. doi: 10.1016/S2213-2600(20)30156-9. Epub 2020 Mar 26. PMID: 32222167; PMCID: PMC7194509.

M585) Spertus JA, Jones PG, Maron DJ, O'Brien SM, Reynolds HR, Rosenberg Y, Stone GW, Harrell FE

Jr, Boden WE, Weintraub WS, Baloch K, Mavromatis K, Diaz A, Gosselin G, Newman JD, Mavromichalis S, Alexander KP, Cohen DJ, Bangalore S, Hochman JS, Mark DB; ISCHEMIA Research Group (McCullough PA, Optimal Medical Management Committee). Health-Status Outcomes with Invasive or Conservative Care in Coronary Disease. N Engl J Med. 2020 Apr 9;382(15):1408-1419. doi: 10.1056/NEJMoa1916370. Epub 2020 Mar 30. PMID: 32227753; PMCID: PMC7261489.

M586) Spertus JA, Jones PG, Maron DJ, Mark DB, O'Brien SM, Fleg JL, Reynolds HR, Stone GW, Sidhu

MS, Chaitman BR, Chertow GM, Hochman JS, Bangalore S; ISCHEMIA-CKD Research Group (McCullough PA Steering Committee). Health Status after Invasive or Conservative Care in Coronary and Advanced Kidney Disease. N Engl J Med. 2020 Apr 23;382(17):1619-1628. doi: 10.1056/NEJMoa1916374. Epub 2020 Mar 30. PMID: 32227754; PMCID: PMC7255621.

M587) Maron DJ, Hochman JS, Reynolds HR, Bangalore S, O'Brien SM, Boden WE, Chaitman BR,

Senior R, López-Sendón J, Alexander KP, Lopes RD, Shaw LJ, Berger JS, Newman JD, Sidhu MS, Goodman SG, Ruzyllo W, Gosselin G, Maggioni AP, White HD, Bhargava B, Min JK, Mancini GBJ, Berman DS, Picard MH, Kwong RY, Ali ZA, Mark DB, Spertus JA, Krishnan MN, Elghamaz A, Moorthy N, Hueb WA, Demkow M, Mavromatis K, Bockeria O, Peteiro J, Miller TD, Szwed H, Doerr R, Keltai M, Selvanayagam JB, Steg PG, Held C, Kohsaka S, Mavromichalis S, Kirby R, Jeffries NO, Harrell FE Jr, Rockhold FW, Broderick S, Ferguson TB Jr, Williams DO, Harrington RA, Stone GW, Rosenberg Y; ISCHEMIA Research Group (McCullough PA, Optimal Medical Management Committee). Initial Invasive or Conservative Strategy for Stable Coronary Disease. N Engl J Med. 2020 Apr 9;382(15):1395-1407. doi: 10.1056/NEJMoa1915922. Epub 2020 Mar 30. PMID: 32227755; PMCID: PMC7263833.

M588) Bangalore S, Maron DJ, O'Brien SM, Fleg JL, Kretov EI, Briguori C, Kaul U, Reynolds HR,

Mazurek T, Sidhu MS, Berger JS, Mathew RO, Bockeria O, Broderick S, Pracon R, Herzog CA, Huang Z, Stone GW, Boden WE, Newman JD, Ali ZA, Mark DB, Spertus JA, Alexander KP, Chaitman BR, Chertow GM, Hochman JS; ISCHEMIA-CKD Research Group (McCullough PA Steering Committee). Management of Coronary Disease in Patients with Advanced Kidney

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Disease. N Engl J Med. 2020 Apr 23;382(17):1608-1618. doi: 10.1056/NEJMoa1915925. Epub 2020 Mar 30. PMID: 32227756; PMCID: PMC7274537.

M589) Packer M, Butler J, Filippatos GS, Jamal W, Salsali A, Schnee J, Kimura K, Zeller C, George J,

Brueckmann M, Anker SD, Zannad F; EMPEROR-Reduced Trial Committees and Investigators (McCullough PA, Steering Committee). Evaluation of the effect of sodium-glucose co-transporter 2 inhibition with empagliflozin on morbidity and mortality of patients with chronic heart failure and a reduced ejection fraction: rationale for and design of the EMPEROR-Reduced trial. Eur J Heart Fail. 2019 Oct;21(10):1270-1278. doi: 10.1002/ejhf.1536. Epub 2019 Jul 16. PubMed PMID:31584231.

M590) Anker SD, Butler J, Filippatos GS, Jamal W, Salsali A, Schnee J, Kimura K, Zeller C, George J,

Brueckmann M, Zannad F, Packer M; EMPEROR-Preserved Trial Committees and Investigators (McCullough PA, Steering Committee). Evaluation of the effects of sodium-glucose co-transporter 2 inhibition with empagliflozin on morbidity and mortality in patients with chronic heart failure and a preserved ejection fraction: rationale for and design of the EMPEROR-Preserved Trial. Eur J Heart Fail. 2019 Oct;21(10):1279-1287. doi: 10.1002/ejhf.1596. Epub 2019 Sep 16. PubMed PMID: 31523904.

M591) Roger SD, Lavin PT, Lerma EV, McCullough PA, Butler J, Spinowitz BS, von Haehling S,

Kosiborod M, Zhao J, Fishbane S, Packham DK. Long-term safety and efficacy of sodium zirconium cyclosilicate for hyperkalaemia in patients with mild/moderate versus severe/end-stage chronic kidney disease: comparative results from an open-label, Phase 3 study. Nephrol Dial Transplant. 2020 Feb 6. pii:gfz285. doi: 10.1093/ndt/gfz285. [Epub ahead of print] PubMed PMID: 32030422.

M592) Oliveros E, Oni ET, Shahzad A, Kluger AY, Lo KB, Rangaswami J, McCullough PA. Benefits and

Risks of Continuing Angiotensin-Converting Enzyme Inhibitors, Angiotensin II Receptor Antagonists, and Mineralocorticoid Receptor Antagonists during Hospitalizations for Acute Heart Failure. Cardiorenal Med. 2020;10(2):69-84. doi: 10.1159/000504167. Epub 2020 Feb 14. Review. PubMed PMID: 32062648.

M593) McCullough PA, Eidt J, Rangaswami J, Lerma E, Tumlin J, Wheelan K, Katz N, Lepor NE, Vijay

K, Soman S, Singh B, McCullough SP, McCullough HB, Palazzuoli A, Ruocco GM, Ronco C. Urgent need for individual mobile phone and institutional reporting of at home, hospitalized, and intensive care unit cases of SARS-CoV-2 (COVID-19) infection. Rev Cardiovasc Med. 2020 Mar 30;21(1):1-7. doi: 10.31083/j.rcm.2020.01.42. PMID: 32259899.

M594) Ronco F, Tarantini G, McCullough PA. Contrast induced acute kidney injury in interventional

cardiology: an update and key guidance for clinicians. Rev Cardiovasc Med. 2020 Mar 30;21(1):9-23. doi: 10.31083/j.rcm.2020.01.44. PMID: 32259900.

M595) Agrawal A, Virk HUH, Riaz I, Jain D, Tripathi B, Krittanawong C, Bozorgnia B, Figueredo V,

McCullough PA, Rangaswami J. Predictors of 30-day re-admissions in patients with infective

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endocarditis: a national population based cohort study. Rev Cardiovasc Med. 2020 Mar 30;21(1):123-127. doi: 10.31083/j.rcm.2020.01.552. PMID: 32259911.

M596) Kazory A, Ronco C, McCullough PA. SARS-CoV-2 (COVID-19) and intravascular volume

management strategies in the critically ill. Proc (Bayl Univ Med Cent). 2020 Apr 16;0(0):1-6. doi: 10.1080/08998280.2020.1754700. PMID: 32336959; PMCID: PMC7171388.

M597) Cedars A, Tecson KM, Zaidi AN, Lorts A, McCullough PA. Impact of Durable Ventricular Assist

Device Support on Outcomes of Patients with Congenital Heart Disease Waiting for Heart Transplant. ASAIO J. 2020 May;66(5):513-519. doi: 10.1097/MAT.0000000000001041. PMID: 31335373.

M598) Lo KB, McCullough PA, Rangaswami J. Mediators of the Effects of Canagliflozin on Heart

Failure: Central Role of the Cardiorenal Axis. JACC Heart Fail. 2020 May;8(5):426. doi: 10.1016/j.jchf.2020.01.013. PMID: 32354418.

M599) Glenister RT, McCullough PA. Analysing risk in heart failure: a Kalium check. Eur J Heart Fail.

2020 May 10. doi: 10.1002/ejhf.1855. Epub ahead of print. PMID: 32390265.

M600) McCullough PA, Arunthamakun J. Disconnect between community testing and hospitalization for SARS-CoV-2 (COVID-19) infection. Proc (Bayl Univ Med Cent). 2020 May 14;33(3):481. doi: 10.1080/08998280.2020.1762439. PMID: 32675999; PMCID: PMC7340440.

M601) Cork DP, McCullough PA, Mehta HS, Barker CM, Gunnarsson C, Ryan MP, Baker ER, Van

Houten J, Mollenkopf S, Verta P. Impact of mitral regurgitation on cardiovascular hospitalization and death in newly diagnosed heart failure patients. ESC Heart Fail. 2020 Aug;7(4):1502-1509. doi: 10.1002/ehf2.12653. Epub 2020 May 29. PMID: 32469120; PMCID: PMC7373926.

M602) Gul F, Lo KB, Peterson J, McCullough PA, Goyal A, Rangaswami J. Meta-analysis of outcomes

of patients with COVID-19 infection with versus without gastrointestinal symptoms. Proc (Bayl Univ Med Cent). 2020 May 29;33(3):366-369. doi: 10.1080/08998280.2020.1771164. PMID: 32669979; PMCID: PMC7265105.

M603) Briedis K, Aldujeli A, Aldujeili M, Briede K, Zaliunas R, Hamadeh A, Stoler RC, McCullough PA.

Considerations for Management of Acute Coronary Syndromes During the SARS-CoV-2 (COVID-19) Pandemic. Am J Cardiol. 2020 Sep 15;131:115-119. doi: 10.1016/j.amjcard.2020.06.039. Epub 2020 Jun 30. PMID: 32723554; PMCID: PMC7324338.

M604) Hamadeh A, Aldujeli A, Briedis K, Tecson KM, Sanz-Sánchez J, Al Dujeili M, Al-Obeidi A, Diez

nas R, Stoler RC, McCullough PA. Characteristics and Outcomes in Patients Presenting With COVID-19 and ST-Segment Elevation Myocardial Infarction. Am J Cardiol. 2020 Sep 15;131:1-6. doi: 10.1016/j.amjcard.2020.06.063. Epub 2020 Jul 3. PMID: 32732010; PMCID: PMC7333635.

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M605) Raju B, Roberts CS, Sathyamoorthy M, Schiffman R, Swift C, McCullough PA. Ventricular Septal Myectomy for the Treatment of Left Ventricular Outflow Tract Obstruction Due to Fabry Disease. Am J Cardiol. 2020 Oct 1;132:160-164. doi: 10.1016/j.amjcard.2020.07.020. Epub 2020 Jul 13. PMID: 32773220.

M606) Velasco CE, Suarez NP, Roullard CP, McCullough PA, Roberts WC. Usefulness of coronary

angiography in patients with left atrial myxoma. Proc (Bayl Univ Med Cent). 2020 Jul 6;33(4):529-531. doi: 10.1080/08998280.2020.1776024. PMID: 33100521; PMCID: PMC7549987.

M607) Gupta S, Hayek SS, Wang W, Chan L, Mathews KS, Melamed ML, Brenner SK, Leonberg-Yoo

A, Schenck EJ, Radbel J, Reiser J, Bansal A, Srivastava A, Zhou Y, Sutherland A, Green A, Shehata AM, Goyal N, Vijayan A, Velez JCQ, Shaefi S, Parikh CR, Arunthamakun J, Athavale AM, Friedman AN, Short SAP, Kibbelaar ZA, Abu Omar S, Admon AJ, Donnelly JP, Gershengorn HB, Hernán MA, Semler MW, Leaf DE; STOP-COVID Investigators (McCullough PA, Site Investigator). Factors Associated With Death in Critically Ill Patients With Coronavirus Disease 2019 in the US. JAMA Intern Med. 2020 Jul 15:e203596. doi: 10.1001/jamainternmed.2020.3596. Epub ahead of print. PMID: 32667668; PMCID: PMC7364338.

M608) Molnar MZ, Bhalla A, Azhar A, Tsujita M, Talwar M, Balaraman V, Sodhi A, Kadaria D, Eason

JD, Hayek SS, Coca SG, Shaefi S, Neyra JA, Gupta S, Leaf DE, Kovesdy CP; STOP-COVID Investigators (McCullough PA, Site Investigator). Outcomes of critically ill solid organ transplant patients with COVID-19 in the United States. Am J Transplant. 2020 Nov;20(11):3061-3071. doi: 10.1111/ajt.16280. Epub 2020 Sep 15. PMID: 32844546; PMCID: PMC7460925.

M609) Singhania N, Bansal S, Nimmatoori DP, Ejaz AA, McCullough PA, Singhania G. Current

Overview on Hypercoagulability in COVID-19. Am J Cardiovasc Drugs. 2020 Aug 4:1–11. doi: 10.1007/s40256-020-00431-z. Epub ahead of print. PMID: 32748336; PMCID: PMC7398761.

M610) McCullough PA, Kelly RJ, Ruocco G, Lerma E, Tumlin J, Wheelan KR, Katz N, Lepor NE, Vijay K,

Carter H, Singh B, McCullough SP, Bhambi BK, Palazzuoli A, De Ferrari GM, Milligan GP, Safder T, Tecson KM, Wang DD, McKinnon JE, O'Neill WW, Zervos M, Risch HA. Pathophysiological Basis and Rationale for Early Outpatient Treatment of SARS-CoV-2 (COVID-19) Infection. Am J Med. 2020 Aug 7:S0002-9343(20)30673-2. doi: 10.1016/j.amjmed.2020.07.003. Epub ahead of print. PMID: 32771461; PMCID: PMC7410805.

M611) Raal FJ, Rosenson RS, Reeskamp LF, Hovingh GK, Kastelein JJP, Rubba P, Ali S, Banerjee P,

Chan KC, Gipe DA, Khilla N, Pordy R, Weinreich DM, Yancopoulos GD, Zhang Y, Gaudet D; ELIPSE HoFH Investigators (McCullough PA Site Investigator). Evinacumab for Homozygous Familial Hypercholesterolemia. N Engl J Med. 2020 Aug 20;383(8):711-720. doi: 10.1056/NEJMoa2004215. PMID: 32813947.

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M612) Elsaid O, McCullough PA, Tecson KM, Williams RS, Yoon A. Ventricular Fibrillation Storm in Coronavirus 2019. Am J Cardiol. 2020 Aug 29:S0002-9149(20)30890-0. doi: 10.1016/j.amjcard.2020.08.033. Epub ahead of print. PMID: 32871109; PMCID: PMC7455792.

M613) Goyal A, Lo KB, Chatterjee K, Mathew RO, McCullough PA, Bangalore S, Rangaswami J. Acute

coronary syndromes in the peri-operative period after kidney transplantation in United States. Clin Transplant. 2020 Sep 18:e14083. doi: 10.1111/ctr.14083. Epub ahead of print. PMID: 32946629.

M614) Palazzuoli A, Ruberto F, De Ferrari GM, Forleo G, Secco GG, Ruocco GM, D'Ascenzo F, Mojoli

F, Monticone S, Paggi A, Vicenzi M, Corcione S, Palazzo AG, Landolina M, Taravelli E, Tavazzi G, Blasi F, Mancone M, Birtolo LI, Alessandri F, Infusino F, Pugliese F, Fedele F, De Rosa FG, Emmett M, Schussler JM, McCullough PA, Tecson KM. Inpatient Mortality According to Level of Respiratory Support Received for Severe Acute Respiratory Syndrome Coronavirus 2 (Coronavirus Disease 2019) Infection: A Prospective Multicenter Study. Crit Care Explor. 2020 Sep 18;2(9):e0220. doi: 10.1097/CCE.0000000000000220. PMID: 32984838; PMCID: PMC7505344.

M615) McCullough PA. Favipiravir and the Need for Early Ambulatory Treatment of SARS-CoV-2

Infection (COVID-19). Antimicrob Agents Chemother. 2020 Nov 17;64(12):e02017-20. doi: 10.1128/AAC.02017-20. PMID: 32967849; PMCID: PMC7674042.

M616) Rangaswami J, Bhalla V, de Boer IH, Staruschenko A, Sharp JA, Singh RR, Lo KB, Tuttle K,

Vaduganathan M, Ventura H, McCullough PA; American Heart Association Council on the Kidney in Cardiovascular Disease; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; and Council on Lifestyle and Cardiometabolic Health. Cardiorenal Protection With the Newer Antidiabetic Agents in Patients With Diabetes and Chronic Kidney Disease: A Scientific Statement From the American Heart Association. Circulation. 2020 Sep 28:CIR0000000000000920. doi: 10.1161/CIR.0000000000000920. Epub ahead of print. PMID: 32981345.

M617) Ruocco G, McCullough PA, Tecson KM, Mancone M, De Ferrari GM, D'Ascenzo F, De Rosa

FG, Paggi A, Forleo G, Secco GG, Pistis G, Monticone S, Vicenzi M, Rota I, Blasi F, Pugliese F, Fedele F, Palazzuoli A. Mortality Risk Assessment Using CHA(2)DS(2)-VASc Scores in Patients Hospitalized With Coronavirus Disease 2019 Infection. Am J Cardiol. 2020 Sep 28:S0002-9149(20)31004-3. doi: 10.1016/j.amjcard.2020.09.029. Epub ahead of print. PMID: 32991860; PMCID: PMC7521434.

M618) Hayek SS, Brenner SK, Azam TU, Shadid HR, Anderson E, Berlin H, Pan M, Meloche C, Feroz R,

O'Hayer P, Kaakati R, Bitar A, Padalia K, Perry D, Blakely P, Gupta S, Shaefi S, Srivastava A, Charytan DM, Bansal A, Mallappallil M, Melamed ML, Shehata AM, Sunderram J, Mathews KS, Sutherland AK, Nallamothu BK, Leaf DE; STOP-COVID Investigators (McCullough PA Site Investigator). In-hospital cardiac arrest in critically ill patients with covid-19: multicenter cohort

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study. BMJ. 2020 Sep 30;371:m3513. doi: 10.1136/bmj.m3513. PMID: 32998872; PMCID: PMC7525342.

M619) Lo KB, Bhargav R, Salacup G, Pelayo J, Albano J, McCullough PA, Rangaswami J. Angiotensin

converting enzyme inhibitors and angiotensin II receptor blockers and outcomes in patients with COVID-19: a systematic review and meta-analysis. Expert Rev Cardiovasc Ther. 2020 Oct 5:1-12. doi: 10.1080/14779072.2020.1826308. Epub ahead of print. PMID: 32945216.

M620) Palazzuoli A, Mancone M, De Ferrari GM, Forleo G, Secco GG, Ruocco GM, D'Ascenzo F,

Monticone S, Paggi A, Vicenzi M, Palazzo AG, Landolina M, Taravelli E, Tavazzi G, Blasi F, Infusino F, Fedele F, De Rosa FG, Emmett M, Schussler JM, Tecson KM, McCullough PA. Antecedent Administration of Angiotensin Converting Enzyme Inhibitors or Angiotensin II Receptor Antagonists and Survival After Hospitalization for SARS-CoV-2 (COVID-19). J Am Heart Assoc. 2020 Oct 7:e017364. doi: 10.1161/JAHA.120.017364. Epub ahead of print. PMID: 33023356.

M621) Zhang J, Tecson KM, McCullough PA. Endothelial dysfunction contributes to COVID-19-

associated vascular inflammation and coagulopathy. Reviews in Cardiovascular Medicine, 2020, 21(3): 315-319. DOI: 10.31083/j.rcm.2020.03.126 https://rcm.imrpress.com/EN/10.31083/j.rcm.2020.03.126

M622) Zhang J, McCullough PA, Tecson KM. Vitamin D deficiency in association with endothelial

dysfunction: Implications for patients with COVID-19. Reviews in Cardiovascular Medicine, 2020, 21(3): 339-344. DOI: 10.31083/j.rcm.2020.03.131 https://rcm.imrpress.com/EN/10.31083/j.rcm.2020.03.131

M623) McCullough PA Innovative Early Sequenced Multidrug Therapy for Sars-Cov-2 (Covid-19)

Infection to Reduce Hospitalization and Death International Journal of Medical Science and Clinical Invention7(12): 5139-5150, 2020 DOI:10.18535/ijmsci/v7i12.02

M624) Flythe JE, Assimon MM, Tugman MJ, Chang EH, Gupta S, Shah J, Sosa MA, Renaghan AD,

Melamed ML, Wilson FP, Neyra JA, Rashidi A, Boyle SM, Anand S, Christov M, Thomas LF, Edmonston D, Leaf DE; STOP-COVID Investigators (McCullough PA Site Investigator). Characteristics and Outcomes of Individuals With Pre-existing Kidney Disease and COVID-19 Admitted to Intensive Care Units in the United States. Am J Kidney Dis. 2020 Sep 19:S0272-6386(20)30999-9. doi: 10.1053/j.ajkd.2020.09.003. Epub ahead of print. PMID: 32961244; PMCID: PMC7501875.

M625) Gupta S, Coca SG, Chan L, Melamed ML, Brenner SK, Hayek SS, Sutherland A, Puri S,

Srivastava A, Leonberg-Yoo A, Shehata AM, Flythe JE, Rashidi A, Schenck EJ, Goyal N, Hedayati SS, Dy R, Bansal A, Athavale A, Nguyen HB, Vijayan A, Charytan DM, Schulze CE, Joo MJ, Friedman AN, Zhang J, Sosa MA, Judd E, Velez JCQ, Mallappallil M, Redfern RE, Bansal AD, Neyra JA, Liu KD, Renaghan AD, Christov M, Molnar MZ, Sharma S, Kamal O, Boateng JO, Short SAP, Admon AJ, Sise ME, Wang W, Parikh CR, Leaf DE; STOP-COVID Investigators (McCullough PA Site Investigator). AKI Treated with Renal Replacement Therapy in Critically Ill Patients with COVID-

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19. J Am Soc Nephrol. 2020 Oct 16:ASN.2020060897. doi: 10.1681/ASN.2020060897. Epub ahead of print. PMID: 33067383.

M626) Gupta S, Wang W, Hayek SS, Chan L, Mathews KS, Melamed ML, Brenner SK, Leonberg-Yoo

A, Schenck EJ, Radbel J, Reiser J, Bansal A, Srivastava A, Zhou Y, Finkel D, Green A, Mallappallil M, Faugno AJ, Zhang J, Velez JCQ, Shaefi S, Parikh CR, Charytan DM, Athavale AM, Friedman AN, Redfern RE, Short SAP, Correa S, Pokharel KK, Admon AJ, Donnelly JP, Gershengorn HB, Douin DJ, Semler MW, Hernán MA, Leaf DE; STOP-COVID Investigators (McCullough PA Site Investigator). Association Between Early Treatment With Tocilizumab and Mortality Among Critically Ill Patients With COVID-19. JAMA Intern Med. 2020 Oct 20:e206252. doi: 10.1001/jamainternmed.2020.6252. Epub ahead of print. PMID: 33080002; PMCID: PMC7577201.

M627) Chertow GM, Pergola PE, Agarwal R, Block GA, Farag YMK, Jardine AG, Koury MJ, Luo W,

Khawaja Z, Lewis EF, Matsushita K, McCullough PA, Parfrey PS, Wittes J, Walters KA, Tseng C, Lin T, Sarnak MJ, Vargo DL, Winkelmayer WC, Eckardt KU. Cardiovascular Safety and Efficacy of Vadadustat for the Treatment of Anemia in Non-Dialysis Dependent CKD: Design and Baseline Characteristics. Am Heart J. 2020 Oct 29:S0002-8703(20)30354-9. doi: 10.1016/j.ahj.2020.10.068. Epub ahead of print. PMID: 33129989.

M628) McCullough PA, Goldstein JA. A novel strategy to prevent contrast nephropathy:

"Continuous hemodiafiltration". Catheter Cardiovasc Interv. 2020 Nov;96(6):1182-1183. doi: 10.1002/ccd.29356. PMID: 33217180.

M629) Aldujeli A, Hamadeh A, Briedis K, Tecson KM, Rutland J, Krivickas Z, Stiklioraitis S, Briede K,

Aldujeili M, Unikas R, Zaliaduonyte D, Zaliunas R, Vallabhan RC, McCullough PA. Delays in Presentation in Patients With Acute Myocardial Infarction During the COVID-19 Pandemic. Cardiol Res. 2020 Dec;11(6):386-391. doi: 10.14740/cr1175. Epub 2020 Nov 2. PMID: 33224384; PMCID: PMC7666599.

M630) Barker CM, Cork DP, McCullough PA, Mehta HS, Houten JV, Gunnarsson C, Mollenkopf S,

Verta P. Healthcare utilization in clinically significant tricuspid regurgitation patients with and without heart failure. J Comp Eff Res. 2020 Nov 11. doi: 10.2217/cer-2020-0198. Epub ahead of print. PMID: 33174767.

M631) Eckardt KU, Agarwal R, Farag YM, Jardine AG, Khawaja Z, Koury MJ, Luo W, Matsushita K,

McCullough PA, Parfrey P, Ross G, Sarnak MJ, Vargo D, Winkelmayer WC, Chertow GM. Global Phase 3 programme of vadadustat for treatment of anaemia of chronic kidney disease: rationale, study design and baseline characteristics of dialysis-dependent patients in the INNO2VATE trials. Nephrol Dial Transplant. 2020 Nov 14:gfaa204. doi: 10.1093/ndt/gfaa204. Epub ahead of print. PMID: 33188693.

M632) Rahimi G, Tecson KM, Elsaid O, McCullough PA. Role of Ischemic Heart Disease in Major

Adverse Renal and Cardiac Events Among Individuals With Heart Failure With Preserved Ejection

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Fraction (from the TOPCAT Trial). Am J Cardiol. 2020 Dec 3:S0002-9149(20)31296-0. doi: 10.1016/j.amjcard.2020.11.034. Epub ahead of print. PMID: 33279481.

M633) Roger SD, Lavin PT, Lerma EV, McCullough PA, Butler J, Spinowitz BS, von Haehling S,

Kosiborod M, Zhao J, Fishbane S, Packham DK. Long-term safety and efficacy of sodium zirconium cyclosilicate for hyperkalaemia in patients with mild/moderate versus severe/end-stage chronic kidney disease: comparative results from an open-label, Phase 3 study. Nephrol Dial Transplant. 2021 Jan 1;36(1):137-150. doi: 10.1093/ndt/gfz285. PMID: 32030422.

M634) McCullough PA, Oskoui R. Early multidrug regimens in new potentially fatal medical

problems. Rev Cardiovasc Med. 2020 Dec 30;21(4):507-508. doi: 10.31083/j.rcm.2020.04.270. PMID: 33387995.

M635) McCullough PA, Alexander PE, Armstrong R, Arvinte C, Bain AF, Bartlett RP, Berkowitz RL,

Berry AC, Borody TJ, Brewer JH, Brufsky AM, Clarke T, Derwand R, Eck A, Eck J, Eisner RA, Fareed GC, Farella A, Fonseca SNS, Geyer CE Jr, Gonnering RS, Graves KE, Gross KBV, Hazan S, Held KS, Hight HT, Immanuel S, Jacobs MM, Ladapo JA, Lee LH, Littell J, Lozano I, Mangat HS, Marble B, McKinnon JE, Merritt LD, Orient JM, Oskoui R, Pompan DC, Procter BC, Prodromos C, Rajter JC, Rajter JJ, Ram CVS, Rios SS, Risch HA, Robb MJA, Rutherford M, Scholz M, Singleton MM, Tumlin JA, Tyson BM, Urso RG, Victory K, Vliet EL, Wax CM, Wolkoff AG, Wooll V, Zelenko V. Multifaceted highly targeted sequential multidrug treatment of early ambulatory high-risk SARS-CoV-2 infection (COVID-19). Rev Cardiovasc Med. 2020 Dec 30;21(4):517-530. doi: 10.31083/j.rcm.2020.04.264. PMID: 33387997.

M636) Procter BC, Ross C, Pickard V, Smith E, Hanson C, McCullough PA. Clinical outcomes after

early ambulatory multidrug therapy for high-risk SARS-CoV-2 (COVID-19) infection. Rev Cardiovasc Med. 2020 Dec 30;21(4):611-614. doi: 10.31083/j.rcm.2020.04.260. PMID: 33388006.

M637) Gupta S, Wang W, Hayek SS, Chan L, Mathews KS, Melamed ML, Brenner SK, Leonberg-Yoo

A, Schenck EJ, Radbel J, Reiser J, Bansal A, Srivastava A, Zhou Y, Finkel D, Green A, Mallappallil M, Faugno AJ, Zhang J, Velez JCQ, Shaefi S, Parikh CR, Charytan DM, Athavale AM, Friedman AN, Redfern RE, Short SAP, Correa S, Pokharel KK, Admon AJ, Donnelly JP, Gershengorn HB, Douin DJ, Semler MW, Hernán MA, Leaf DE; STOP-COVID Investigators. (McCullough PA Site Investigator). Association Between Early Treatment With Tocilizumab and Mortality Among Critically Ill Patients With COVID-19. JAMA Intern Med. 2021 Jan 1;181(1):41-51. doi: 10.1001/jamainternmed.2020.6252. PMID: 33080002; PMCID: PMC7577201.

M638) Palazzuoli A, Ruocco G, Tecson KM, McCullough PA. Screening, detection, and management

of heart failure in the SARS-CoV2 (COVID-19) pandemic. Heart Fail Rev. 2021 Jan 6:1–7. doi: 10.1007/s10741-020-10068-4. Epub ahead of print. PMID: 33405001; PMCID: PMC7786335.

M639) Al-Samkari H, Gupta S, Leaf RK, Wang W, Rosovsky RP, Brenner SK, Hayek SS, Berlin H,

Kapoor R, Shaefi S, Melamed ML, Sutherland A, Radbel J, Green A, Garibaldi BT, Srivastava A,

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Leonberg-Yoo A, Shehata AM, Flythe JE, Rashidi A, Goyal N, Chan L, Mathews KS, Hedayati SS, Dy R, Toth-Manikowski SM, Zhang J, Mallappallil M, Redfern RE, Bansal AD, Short SAP, Vangel MG, Admon AJ, Semler MW, Bauer KA, Hernán MA, Leaf DE; STOP-COVID-19 Investigators (McCullough PA Site Investigator). Thrombosis, Bleeding, and the Observational Effect of Early Therapeutic Anticoagulation on Survival in Critically Ill Patients With COVID-19. Ann Intern Med. 2021 Jan 26:M20-6739. doi: 10.7326/M20-6739. Epub ahead of print. PMID: 33493012; PMCID: PMC7863679.

M640) Zhang J, Tecson KM, McCullough PA. Role of endothelial cell receptors in the context of

SARS-CoV-2 infection (COVID-19). Proc (Bayl Univ Med Cent). 2021 Jan 26;34(2):262-268. doi: 10.1080/08998280.2021.1874231. PMID: 33664552; PMCID: PMC7852287.

M641) Shaefi S, Brenner SK, Gupta S, O'Gara BP, Krajewski ML, Charytan DM, Chaudhry S, Mirza SH,

Peev V, Anderson M, Bansal A, Hayek SS, Srivastava A, Mathews KS, Johns TS, Leonberg-Yoo A, Green A, Arunthamakun J, Wille KM, Shaukat T, Singh H, Admon AJ, Semler MW, Hernán MA, Mueller AL, Wang W, Leaf DE; STOP-COVID Investigators (McCullough PA Site Investigator). Extracorporeal membrane oxygenation in patients with severe respiratory failure from COVID-19. Intensive Care Med. 2021 Feb;47(2):208-221. doi: 10.1007/s00134-020-06331-9. Epub 2021 Feb 2. PMID: 33528595; PMCID: PMC7851810.

M642) Short SAP, Gupta S, Brenner SK, Hayek SS, Srivastava A, Shaefi S, Singh H, Wu B, Bagchi A, Al-

Samkari H, Dy R, Wilkinson K, Zakai NA, Leaf DE; STOP-COVID Investigators(McCullough PA Site Investigator). D-dimer and Death in Critically Ill Patients With Coronavirus Disease 2019. Crit Care Med. 2021 Feb 12. doi: 10.1097/CCM.0000000000004917. Epub ahead of print. PMID: 33591017.

M643) Mathews KS, Soh H, Shaefi S, Wang W, Bose S, Coca S, Gupta S, Hayek SS, Srivastava A,

Brenner SK, Radbel J, Green A, Sutherland A, Leonberg-Yoo A, Shehata A, Schenck EJ, Short SAP, Hernán MA, Chan L, Leaf DE; Study of the Treatment and Outcomes in Critically Ill Patients with Coronavirus Disease (STOP-COVID) Investigators(McCullough PA Site Investigator). Prone Positioning and Survival in Mechanically Ventilated Patients With Coronavirus Disease 2019-Related Respiratory Failure. Crit Care Med. 2021 Feb 17. doi: 10.1097/CCM.0000000000004938. Epub ahead of print. PMID: 33595960.

M644) Aldujeli A, Hamadeh A, Tecson KM, Krivickas Z, Maciulevicius L, Stiklioraitis S, Sukys M,

Briedis K, Aldujeili M, Briede K, Braukyliene R, Pranculis A, Unikas R, Zaliaduonyte D, McCullough PA. Six-Month Outcomes for COVID-19 Negative Patients with Acute Myocardial Infarction Before Versus During the COVID-19 Pandemic. Am J Cardiol. 2021 Feb 23:S0002-9149(21)00161-2. doi: 10.1016/j.amjcard.2021.01.043. Epub ahead of print. PMID: 33631113; PMCID: PMC7900754.

M645) McCullough PA, Rahimi G, Tecson KM. Ambulatory Worsening of Renal Function in Heart

Failure With Preserved Ejection Fraction. J Am Coll Cardiol. 2021 Mar 9;77(9):1222-1224. doi: 10.1016/j.jacc.2021.01.007. PMID: 33663740.

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M646) Kalantar-Zadeh K, McCullough PA, Agarwal SK, Beddhu S, Boaz M, Bruchfeld A, Chauveau P,

Chen J, de Sequera P, Gedney N, Golper TA, Gupta M, Harris T, Hartwell L, Liakopoulos V, Kopple JD, Kovesdy CP, Macdougall IC, Mann JFE, Molony D, Norris KC, Perlmutter J, Rhee CM, Riella LV, Weisbord SD, Zoccali C, Goldsmith D. Nomenclature in nephrology: preserving 'renal' and 'nephro' in the glossary of kidney health and disease. J Nephrol. 2021 Mar 13. doi: 10.1007/s40620-021-01011-3. Epub ahead of print. PMID: 33713333.

M647) McCullough PA. Anemia of cardiorenal syndrome. Kidney Int Suppl (2011). 2021

Apr;11(1):35-45. doi: 10.1016/j.kisu.2020.12.001. Epub 2021 Mar 18. PMID: 33777494; PMCID: PMC7983020.

M648) Lo KB, Toroghi HM, Salacup G, Jiang J, Bhargav R, Quintero E, Balestrini K, Shahzad A,

Mathew RO, McCullough PA, Rangaswami J. Angiotensin converting enzyme inhibitors and angiotensin receptor blockers in acute heart failure: invasive hemodynamic parameters and clinical outcomes. Rev Cardiovasc Med. 2021 Mar 30;22(1):199-206. doi: 10.31083/j.rcm.2021.01.216. PMID: 33792263.

M649) Kellum JA, Artigas A, Gunnerson KJ, Honore PM, Kampf JP, Kwan T, McPherson P, Nguyen

HB, Rimmelé T, Shapiro NI, Shi J, Vincent JL, Chawla LS; Sapphire Investigators (McCullough PA Site Investigator). Use of Biomarkers to Identify Acute Kidney Injury to Help Detect Sepsis in Patients With Infection. Crit Care Med. 2021 Apr 1;49(4):e360-e368. doi: 10.1097/CCM.0000000000004845. PMID: 33566467; PMCID: PMC7963439.

M650) Procter BC, Ross C, Pickard V, Smith E, Hanson C, McCullough PA. Early Ambulatory

Multidrug Therapy Reduces Hospitalization and Death in High-Risk Patients with SARS-CoV-2 (COVID-19). ijirms [Internet]. 2021Mar.17 [cited 2021Apr.28];6(03):219 - 221. https://www.ijirms.in/index.php/ijirms/article/view/1100, https://www.ijirms.in/index.php/ijirms/article/view/1100#downloadTab

M651) McCullough PA, Vijay K. SARS-CoV-2 infection and the COVID-19 pandemic: a call to action

for therapy and interventions to resolve the crisis of hospitalization, death, and handle the aftermath. Rev Cardiovasc Med. 2021 Mar 30;22(1):9-10. doi: 10.31083/j.rcm.2021.01.301. PMID: 33792243.

M652) Valdenor C, McCullough PA, Paculdo D, Acelajado MC, Dahlen JR, Noiri E, Sugaya T, Peabody

J. Measuring the Variation in the Prevention and Treatment of CI-AKI Among Interventional Cardiologists. Curr Probl Cardiol. 2021 Apr 3:100851. doi: 10.1016/j.cpcardiol.2021.100851. Epub ahead of print. PMID: 33994040.

M653) Ishida JH, Chauhan C, Gillespie B, Gruchalla K, McCullough PA, Quella S, Romero A, Rossignol

P, Wheeler DC, Malley MA, West M, Herzog CA. Understanding and Overcoming the Challenges Related to Cardiovascular Trials Involving Patients with Kidney Disease. Clin J Am Soc Nephrol. 2021 Apr 23:CJN.17561120. doi: 10.2215/CJN.17561120. Epub ahead of print. PMID: 33893163.

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M654) Chertow GM, Pergola PE, Farag YMK, Agarwal R, Arnold S, Bako G, Block GA, Burke S, Castillo

FP, Jardine AG, Khawaja Z, Koury MJ, Lewis EF, Lin T, Luo W, Maroni BJ, Matsushita K, McCullough PA, Parfrey PS, Roy-Chaudhury P, Sarnak MJ, Sharma A, Spinowitz B, Tseng C, Tumlin J, Vargo DL, Walters KA, Winkelmayer WC, Wittes J, Eckardt KU; PRO2TECT Study Group. Vadadustat in Patients with Anemia and Non-Dialysis-Dependent CKD. N Engl J Med. 2021 Apr 29;384(17):1589-1600. doi: 10.1056/NEJMoa2035938. PMID: 33913637.

M655) Eckardt KU, Agarwal R, Aswad A, Awad A, Block GA, Bacci MR, Farag YMK, Fishbane S, Hubert

H, Jardine A, Khawaja Z, Koury MJ, Maroni BJ, Matsushita K, McCullough PA, Lewis EF, Luo W, Parfrey PS, Pergola P, Sarnak MJ, Spinowitz B, Tumlin J, Vargo DL, Walters KA, Winkelmayer WC, Wittes J, Zwiech R, Chertow GM. Safety and Efficacy of Vadadustat for Anemia in Patients Undergoing Dialysis. N Engl J Med. 2021 Apr 29;384(17):1601-1612. doi: 10.1056/NEJMoa2025956. PMID: 33913638.

M656) Short SAP, Gupta S, Brenner SK, Hayek SS, Srivastava A, Shaefi S, Singh H, Wu B, Bagchi A, Al-

Samkari H, Dy R, Wilkinson K, Zakai NA, Leaf DE; STOP-COVID Investigators (McCullough PA Site Investigator). d-dimer and Death in Critically Ill Patients With Coronavirus Disease 2019. Crit Care Med. 2021 May 1;49(5):e500-e511. doi: 10.1097/CCM.0000000000004917. PMID: 33591017.

M657) Swolinsky JS, Nerger NP, Leistner DM, Edelmann F, Knebel F, Tuvshinbat E, Lemke C, Roehle

R, Haase M, Costanzo MR, Rauch G, Mitrovic V, Gasanin E, Meier D, McCullough PA, Eckardt KU, Molitoris BA, Schmidt-Ott KM. Serum creatinine and cystatin C-based estimates of glomerular filtration rate are misleading in acute heart failure. ESC Heart Fail. 2021 May 6. doi: 10.1002/ehf2.13404. Epub ahead of print. PMID: 33955699.

M658) Palazzuoli A, Tecson KM, Ronco C, McCullough PA. Nomenclature for Kidney Function from

KDIGO: Shortcomings of Terminology Oversimplification. Cardiorenal Med. 2021 Jun 4:1-4. doi: 10.1159/000516615. Epub ahead of print. PMID: 34091445.

M659) Vasquez CR, Gupta S, Miano TA, Roche M, Hsu J, Yang W, Holena DN, Reilly JP, Schrauben SJ,

Leaf DE, Shashaty MGS; STOP-COVID Investigators (McCullough PA Site Investigator). Identification of Distinct Clinical Subphenotypes in Critically Ill Patients With COVID-19. Chest. 2021 May 6:S0012-3692(21)00874-6. doi: 10.1016/j.chest.2021.04.062. Epub ahead of print. PMID: 33964301; PMCID: PMC8099539.

M660) Alexander PE, Armstrong R, Fareed G, Lotus J, Oskoui R, Prodromos C, Risch HA, Tenenbaum

HC, Wax CM, Dara P, McCullough PA, Gill KK. Early multidrug treatment of SARS-CoV-2 infection (COVID-19) and reduced mortality among nursing home (or outpatient/ambulatory) residents. Med Hypotheses. 2021 Jun 5;153:110622. doi: 10.1016/j.mehy.2021.110622. Epub ahead of print. PMID: 34130113; PMCID: PMC8178530.

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M661) Mathews KS, Soh H, Shaefi S, Wang W, Bose S, Coca S, Gupta S, Hayek SS, Srivastava A, Brenner SK, Radbel J, Green A, Sutherland A, Leonberg-Yoo A, Shehata A, Schenck EJ, Short SAP, Hernán MA, Chan L, Leaf DE; STOP-COVID Investigators (McCullough PA Site Investigator) . Prone Positioning and Survival in Mechanically Ventilated Patients With Coronavirus Disease 2019-Related Respiratory Failure. Crit Care Med. 2021 Jul 1;49(7):1026-1037. doi: 10.1097/CCM.0000000000004938. PMID: 33595960; PMCID: PMC8277560.

M662) McCullough PA, Mehta HS, Barker CM, Houten JV, Mollenkopf S, Gunnarsson C, Ryan M,

Cork DP. Healthcare utilization and guideline-directed medical therapy in heart failure patients with reduced ejection fraction. J Comp Eff Res. 2021 Jul 6. doi: 10.2217/cer-2021-0118. Epub ahead of print. PMID: 34225473.

M663) Palazzuoli A, Tecson KM, McCullough PA. Impact of renin-angiotensin-aldosterone system

inhibitor continuation on outcomes for patients with severe coronavirus disease 2019 manifestations. J Hypertens. 2021 Aug 1;39(8):1725-1726. doi: 10.1097/HJH.0000000000002876. PMID: 34188007.

M664) McCullough PA, Mehta HS, Barker CM, Van Houten J, Mollenkopf S, Gunnarsson C, Ryan M,

Cork DP. Mortality and guideline-directed medical therapy in real-world heart failure patients with reduced ejection fraction. Clin Cardiol. 2021 Aug 3. doi: 10.1002/clc.23664. Epub ahead of print. PMID: 34342033.

Published Letters

ltr1) McCullough PA, O'Neill WW. Letter to the Editor: Regional Variation Across the United States in the Management of Acute Myocardial Infarction. New Engl J Med 1996;334:194; discussion 194-5. PMID: 96127997

ltr2) McCullough PA, O’Neill WW. Letter to the Editor: Patient care after percutaneous coronary artery interventions. Ann Intern Med 1998 Apr 1;128:598; discussion 599-600. PMID: 98175287

ltr3) McCullough PA, Redle JD. Letter to the Editor: Amiodarone Prophylaxis for Atrial Fibrillation after Bypass Surgery. New Engl J Med 1998;338:1383; discussion 1384. PMID: 98223116

ltr4) Sharma ND, McCullough PA. Letter to the Editor: Predictability of left ventricular thrombus by mitral regurgitation. Am Heart J 1999 Feb;137(2):373-5. PMID: 99156058

ltr5) McCullough PA, Marks KR. Letter to the Editor: Ticlopidine and TTP after Coronary Stenting.

JAMA 1999;282(18):1717-1718;discussion 1718-9. PMID: 10568636 ltr6) McCullough PA, Sandberg KR, Thompson RJ. Letter to the Editor: Predicting Outcomes after

Cardiopulmonary Resuscitation. Arch Intern Med 2001;161(4):615-616. PMID: 11252131

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ltr7) McCullough PA. Letter to the Editor: The Anti-inflammatory Effect of Statins. N Engl J Med. 2001 Oct 18;345(16):1209; discussion 1210-1. PMID: 11642241

ltr8) McCullough PA, Sandberg KR, Borzak S. Letter to the Editor: Cardiovascular outcomes and

renal disease. Ann Intern Med. 2002 Apr 16;136(8):633-4; discussion 633-4. PMID: 11955038 ltr9) McCullough PA. Reply to Manhapra A, Why is chronic kidney disease the "spoiler" for

cardiovascular outcomes: an alternate take from a generalist. J Am Coll Cardiol. 2004 Mar 3;43(5):924; author reply 924-5. PMID: 15006584

ltr10) Omland T, Knudsen CW, McCullough PA, Maisel AS. Response to LTE. #2005-624 - Schwam.

Ann Emerg Med. 2006 Feb;47(2):214. PMID: 16431243 ltr11) Barker D, Artis N, Tan LB, DeJong A, Franklin BA, McCullough PA. Correcting data for body

size may confound results. Chest. 2006 Feb;129(2):493-4. PMID: 16478872 ltr12) McCullough PA. Failure of beta-blockers in the reduction of perioperative events: Where did

we go wrong? Response to the letter to the Editor by Souza et al. Am Heart J. 2007 Jun;153(6):e39. PMID: 17540183

ltr13) McCullough PA. Multimodality prevention of contrast-induced acute kidney injury, In Reply.

Am J Kidney Dis. 2008 Jun;51(6):1068-1069. PMID: 18501789 ltr14) McCullough PA, Collins AJ, Vassalotti JA. Rapid Response: Optimal Definition of Chronic

Kidney Disease as a Cardiovascular Risk State. Southern Medical Journal, Volume 101, 977 Number 10, October 2008

ltr15) Neyou A, McCullough PA. Response to letter to the editor. Am J Emerg Med. 2010 Dec 1.

[Epub ahead of print] No abstract available. PMID: 21129890 ltr16) Palazzuoli A, Ronco C, McCullough PA. Letter by Palazzuoli et al regarding article, "is

worsening renal function an ominous prognostic sign in patients with acute heart failure? The role of congestion and its interaction with renal function". Circ Heart Fail. 2012 Jul 1;5(4):e79. PubMed PMID: 22811554

ltr17) O'Keefe JH, Patil HR, Magalski A, Lavie CJ, Vogel RA, McCullough PA. In reply. Mayo Clin

Proc. 2012 Nov;87(11):1133-4. doi: 10.1016/j.mayocp.2012.08.010. PubMed PMID: 23127740

ltr18) McCullough PA. Reply: Vitamin E May Protect Against Contrast-Induced Acute Kidney Injury. J Am Coll Cardiol. 2017 Apr 11;69(14):1878-1879. doi: 10.1016/j.jacc.2017.01.053. PubMed PMID: 28385321

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ltr19) Rangaswami J, McCullough PA. Efficacy of Subcutaneous Versus Intravenous Administration of Furosemide in Patients With Worsening Heart Failure: The Devil Is in the Details. JACC Heart Fail. 2018 Mar;6(3):266-267. doi: 10.1016/j.jchf.2018.01.010. PubMed PMID: 29496028

ltr20) Rangaswami J, McCullough PA. Clinical Context of Dyskalemias Across the Heart Failure

Spectrum and Their Associated Adverse Outcomes. JACC Heart Fail. 2019 Jun;7(6):533. doi: 10.1016/j.jchf.2019.01.005. PubMed PMID: 31146878.

ltr21) McCullough PA. The Reply. Am J Med. 2021 Mar;134(3):e222-e223. doi:

10.1016/j.amjmed.2020.10.036. PMID: 33637181; PMCID: PMC7901366.

ltr22) McCullough PA. The Reply. Am J Med. 2021 Apr;134(4):e298. doi: 10.1016/j.amjmed.2020.11.028. PMID: 33888224; PMCID: PMC8054639.

ltr23) McCullough PA. Regarding: "Hydroxychloroquine: a comprehensive review and its

controversial role in coronavirus disease 2019". Ann Med. 2021 Dec;53(1):286. doi: 10.1080/07853890.2021.1872094. PMID: 33439042; PMCID: PMC7877973.

ltr24) McCullough PA. The Reply. Am J Med. 2021 May;134(5):e343-e344. doi:


ltr25) McCullough PA. The Reply. Am J Med. 2021 May;134(5):e346-e347. doi: 10.1016/j.amjmed.2021.01.013. PMID: 33962710; PMCID: PMC8095728.

ltr26) McCullough PA. The Reply. Am J Med. 2021 Jul;134(7):e440-e441. doi:


Textbook Chapters

T1) McCullough PA, Goldstein JG. Chapter 5: Heart Pressures and Catheterization. Cardiac Catheterization: Concepts, Techniques, and Applications. Uretsky BF, Editor, Blackwell Science, Inc., Boston, 1997. ISBN 9780865424067

T2) McCullough PA. Section III, Chapter 7: Epidemiology of Coronary Heart Disease.

Interventional Cardiovascular Medicine: Principles and Practice, Second Edition. Roubin GS, O’Neill WW, Stack RS, Editors, Churchill Livingstone Inc., Philadelphia and New York, 2002, III, 7, 138-159. ISBN 9780443079795

T3) Franklin BA, McCullough PA, Timmis GC. Chapter: Exercise. Randomized Trials in

Cardiovascular Disease: a Companion Volume to Eugene Braunwald’s “Heart Disease.” Hennekins CH, Buring JE, Ridker PM, Manson JE, Editors, W. B. Saunders Inc., New York, 1998.

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T4) McCullough PA. Chapter 4. General Examination and Examination Skills, p 41-57 Clinical Exercise Physiology. Ehrman JK, Gordon PM, Visich PS, Keteyian SJ, Editors, Human Kinetics Publishers, Inc., 2003. ISBN 9780736002523

T5) Malineni K, McCullough PA. Chapter: Sudden Cardiac Death, eMedicine.com, Textbook of

Medicine, Obstetrics and Gynecology, Psychiatry, and Surgery, 2001.

T6) McCullough PA. Chapter 21: Outcome of Myocardial Infarction in Patients with Renal Failure, Harrison’s Advances in Cardiology, Eugene Braunwald, M.D., Editor, 2003. pp 123-128. McGraw-Hill, New York, NY. ISBN 9780071370882

T7) McCullough PA. Chapter 26. Renal Injury Following Contrast Agents, Peripheral Vascular

Disease: Basic Diagnosis and Therapeutic Approaches, Editor: George S. Abela, MD, 2003, pp 000-000. Lippincott Williams & Wilkins, Philadelphia, PA. ISBN 9780781743839

T8) McCullough PA. The effect of renal disease on outcomes of vascular surgery. Fast Facts in

Vascular Surgery, Health Press, Alun H. Davies, MA, DM, FRCS, Editor, 2003-2004;74-86. ISBN 9781903734513

T9) McCullough PA. Interface between renal disease and cardiovascular illness. Braunwald’s

Heart Disease, 7th Edition, 2004, Zipes DP, Libby P, Bonow RO, Braunwald E, Editors, WB Saunders, Inc. ISBN 9780721604794

T10) McCullough PA. Interface between renal disease and cardiovascular illness.

Braunwald’s Heart Disease, 8th Edition, 2006, Zipes DP, Libby P, Bonow RO, Braunwald E, Editors, WB Saunders, Inc. ISBN 9781416041030

T11) McCullough PA. Chapter 23. Renal Complications of Contrast Media: Contrast-

Induced Nephropathy, p 239-249. Interventional Cardiology, 1st Edition, 2007. King S, Yeung A, Editors. The McGraw-Hill Medical, New York. ISBN 9780071415279

T12) McCullough PA. Chapter 14. Natriuretic peptides in patients with renal failure, p

170-180. Markers in Cardiology: A Case Oriented Approach, 2007. Adams JE, Jaffe AS, Apple F, Editors. Blackwell Futura, 2007. ISBN 9781405134187

T13) Miller WM, McCullough PA. Chapter 21. Obesity, p209-218. Pollock’s Textbook of

Cardiovascular Disease and Rehabilitation. Durstine JL, Moore GE, LaMonte MJ, Franklin BA, Editors. Human Kinetics, 2008. ISBN 0000736059679

T14) Franklin BA, Miller WM, McCullough PA. Chapter 11: The Metabolic Syndrome.

American Council on Exercise Advanced Health and Fitness Specialist Manual. Edited by Bryant CX, Green DJ. San Diego, CA. American Council on Exercise; 2008:239-254. ISBN 9781890720278

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T15) Marso SP, McCullough PA. Chapter 8: Patient-Specific Approaches and Considerations: Unique Subgroups—Diabetes, Renal Failure, Advanced Age. American College of Cardiology Cardiac Catheterization and Interventional Self-Assessment Program 3 (CathSAP-3), David J. Moliterno, Editor. ACC, 2008. http://www.cardiosource.com/GenSAPX/

T16) Franklin BA, Miller WM, Nori K, McCullough PA. Chapter 12: Guidelines for Exercise

Testing in Diabetics Starting an Exercise Program. Contemporary Diabetes: Diabetes and Exercise. Edited by Regensteiner JC, Reusch JEB, Stewart K, Veves A. Totowa, NJ: Humana Press; 2009:263-277. ISBN 9781588299260

T17) Nguyen, T, Yee T, Mai T, Phan T, McCullough PA. Chapter 6: Diet. Evidence Based

Cardiology Practice: A 21st Century Approach. Edited by Hu D, Nguyen T, Kim MH, Kwan T, Grines CL, Saito S. Peoples Medical Publishing House—USA, Shelton, CT; 2010; 145-161. ISBN 9781607950950

T18) Kodenchery M, Bhat S, El-Ghoroury M, Yamasaki H, McCullough PA. "Coronary

Angiography Before and After Renal Transplantation" Coronary Angiography - The Need for Improvement in Medical and Interventional Therapy, edited by Branislav Baškot. InTech - Open Access Publisher, Rijeka, Croatia, Website: http://www.intechweb.org/, permanent web address: http://www.intechopen.com/articles/show/title/coronary-angiography-before-and-after-renal-transplantation. ISBN 9789533076416

T19) Marinescu V, McCullough PA. Chapter 5d. Managing Comorbidities. Chronic Kidney

Disease. Hypertension. Bakris G and Baliga RR Editors, Oxford American Cardiology Library, Oxford University Press, New York, NY 2012; 71-81. ISBN 9780199754908

T20) McCullough PA. Chapter 43. Contrast-Induced Acute Kidney Injury. Specialty Board

Review: Cardiology. Baliga RR Editor. The McGraw-Hill Companies, Inc., China, 2012; 467-473. ISBN 9780071614085

T21) Zalesin KC, Franklin BA, Miller WM, Peterson ED, McCullough PA. Impact of obesity

on cardiovascular disease. Medical Clinics of North America: Obesity. LeRoith D and Karnieli E, Editors. WB Saunders Company, New York, NY, 2011 95(5):919-937. ISBN 9781455723690

T22) McCullough PA. Chapter: Interface between renal disease and cardiovascular

illness. Braunwald’s Heart Disease, 9th Edition, 2011. Zipes DP, Libby P, Bonow RO, Braunwald E, Editors, WB Saunders, Inc. ISBN 9781437727081

T23) Hanson ID, McCullough PA. B-type natriuretic peptide: beyond diagnostic

applications. The Kidney in Heart Failure. Bakris GL Editor. Springer, New York, NY, 2012;67-77. ISBN 9781461436935

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T24) Brown JE, McCullough PA. Chapter 5: Contrast Nephropathy and Kidney Injury. Textbook of Cardiovascular Intervention, Thompson, CA (Editor), Springer, 2014 (5) 53-63. ISBN 9781447145288

T25) Franklin BA, Miller WM, McCullough PA. Chapter 12, The Metabolic Syndrome,

American Medical Council, Medical Exercise Specialist Manual, Skinner JS, Bryant CX, Merrill S, Green DJ. American Council on Exercise 2015, San Diego CA. ISBN 9781890720520

T26) Stewart D, Shah G, Brown JR, McCullough, PA. Chapter 240 Contrast-induced acute

kidney injury, Oxford Textbook of Clinical Nephrology, 4th Edition, Managing Editors Turner Goldsmith DJ, Winearls C, Lamierre N, Himmelfarb J, Remuzzi G, Editors, 2015, Oxford University Press, United Kingdom. ISBN 9780199592548

T27) Goldsmith DJ, Kumar N, Henderson H, Cameron BD, McCullough PA. Chapter 106

Malnutrition, obesity, and undernutrition in chronic kidney disease, Oxford Textbook of Clinical Nephrology, 4th Edition, Managing Editors Turner Goldsmith DJ, Winearls C, Lamierre N, Himmelfarb J, Remuzzi G, Editors, 2015, Oxford University Press, United Kingdom. ISBN 9780199592548

T28) McCullough PA. Chapter 18 Future Therapeutic Prospects for Treatment of Cardiorenal Syndromes, p 189-195, Cardiorenal Challenges. Goldsmith DA, Covic A, Spaak J. Editors, Springer International Publishing AG, Cham, 2015, Zug, Switzerland. ISBN 9783319091624

T29) McCullough PA. Chapter 88: Interface between renal disease and cardiovascular

illness. Braunwald’s Heart Disease, 10th Edition, 2015, pp 1909-1930. Zipes DP, Libby P, Bonow RO, Braunwald E, Editors, WB Saunders, Inc. ISBN 9781455751334

T30) McCullough PA. Chapter 24: Cardiovascular Disease in Chronic Kidney Disease.

Essentials of Chronic Kidney Disease, 2015, pp 239-245. Fadem SZ, Editor, Nova Publishers, ISBN-13: 978-1634825429

T31) Prasad A, McCullough PA. Chapter 19: Renal Complications of Contrast Media.

Interventional Cardiology, 2nd Edition, 2018, pp 293-306. Samady H, Fearon WF, Yeung AC, King SB, Editors, McGraw-Hill, ISBN-13: 978-0071820363

T32) Rangaswami J, Lerma EV, McCullough PA, Editors. Kidney Disease in the Cardiac

Catheterization Laboratory, 1st Edition 2020, ISBN-13: 978-3030454135 ISBN-10: 3030454134, Springer Nature Switzerland AG. Chapter 27 Ronco C, Ronco F, McCullough PA. A Call to Action to Develop Integrated Curricula in Cardiorenal Medicine, pp 449-463.

T33) McCullough PA, Ronco C. Textbook of Cardiorenal Medicine, 1st Edition 2021, ISBN-

13: 978-3030574598 ISBN-10: 3030574598, Springer Nature Switzerland AG. Chapter 1 McCullough PA, Kluger AY. Implications of Chronic Kidney Disease on the Epidemiology of

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Cardiovascular Disease, pp 1-6. Chapter 8 Rocha N, McCullough PA. Type 2 Cardiorenal Syndrome, pp 75-94. Chapter 17 McCullough PA Novel Biomarkers of Chronic Cardiorenal Disease, pp 227-234.

.

Invited Non-Peer Reviewed Works

1) McCullough PA. Acute Renal Failure after Coronary Intervention. American College of Cardiology Educational Highlights, Fall 1997 Issue, C.R. Conti, Editor

2) McCullough PA, Thompson RJ, Tobin KJ, Kahn JK, Schwender F, O’Neill WW. Outcome of

Out-of-Hospital Cardiac Arrest Survivors. Cardiology Review, 2000;17:15-19

3) Thompson RJ, McCullough PA, Kahn JK, O’Neill WW. A Simple Scoring System to Predict Clinical Outcome after Resuscitation from Cardiac Arrest. The Journal of Critical Illness, 1998;13:298-300

4) McCullough PA. Clinical Evaluation. Part I. The Cardiopulmonary System. Clinical Exercise

Physiology, 1999;1:33-41

5) McCullough PA. Clinical Evaluation. Part II. The Musculoskeletal and other Body Systems. Clinical Exercise Physiology, 1999:1:92-99

6) McCullough PA. Ridogrel: Literature Evaluation. IDdb Reports, Current Drugs Ltd,

February, 1999

7) McCullough PA. Debate Commentary: Complete Assessment of the Lipid Profile is Advised. Medical Crossfire, 1999:5;52

8) McCullough PA. Narrative Fields in Hospital Records. Invited comment on Loss of Narrative

Data in New Zealand Health Statistics Public Hospital Injury Files, John Langley (Australasian Epidemiologist 1998:5.4). The Australasian Epidemiologist, 1999;6.1:17-18

9) McCullough PA. Previews in Cardiovascular Medicine: Prediction and Prevention of

Contrast Nephropathy. Rev Cardiovasc Med. 2001;2(Suppl 1):S1-S3

10) Creager MA, Faxon DP, Fonarow GC, Gross SB, Hachamovitch R, Jacobs AK, Lepor NE, McCullough PA, Naqvi T, Nesto RW, Prystowsky EN, Shah PK, Vogel RA, Yeung AC. Meeting Reviews: Best of the AHA Scientific Sessions, 2001. Rev Cardiovasc Med. 2002;3(1):22-48

11) McCullough PA. Update from the International Society on Hypertension in Blacks.

Rev Cardiovasc Med. 2002 Fall;3(4):192-95. PMID: 12650156

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12) Nguyen PN, Spertus JA, McCullough PA. Is there a Heart Failure Epidemic? Cardiology Review 2002;19(9):32-36

13) Lepor NE, Yeung AC, McCullough PA, Creager MA, Weber MA, Jacobs AK, Faxon DP, Vogel

RA, Gersh BJ. Meeting Review: Best of the ACC Scientific Session 2002. Rev Cardiovasc Med 2002;3(2):85-104

14) Franklin BA, deJong A, McCullough PA. Interpreting Exercise Test-Fitness Data for Your

Patients. Am J Sports 2003;5:12-17

15) McCullough PA. The interface between heart disease and renal dysfunction: from association to action. ACC Current Journal Review 2003;12(2):20-24

16) Fonarow GC, Prystowsky EN, McCullough PA, Lepor NE, Watson KE, Gersh BJ, Young JJ,

Kereiakes D, Faxon DP, Weyman A, Jacobs AK, Yeung A, Holmes D, Berger P, Weber MA. Meeting Review: Best of the ACC Scientific Sessions 2003. Rev Cardiovasc Med. 2003;4(3):150-179

17) McCullough PA. Debate Commentary: Atrial Fibrillation: Preventing Thromboembolism

and Ischemic Stroke. Medical Crossfire 2003, 4(10), 3-17

18) Creager M, Faxon DP, Gersh BJ, Jacobs AK, Lepor NE, McCullough PA, Naqvi T, Prystowsky EN, Shah PK, Watson KE, Weber MA, Wyman A. Meeting Review: Best of the AHA Scientific Sessions 2003. Rev Cardiovasc Med 2004;5(1)26-52

19) McCullough PA. The use of contrast media in peripheral, combined, and sequential

procedures. Applications in Imaging: Cardiac Interventions: Contrast Use in Renally Compromised Patients 2003;Sept:47-51

20) McCullough PA. Chapter Four: Major Risk Factors for Chronic Kidney Disease. Kidney Early

Evaluation Program Annual Data Report. Am J Kid Dis 2003;42(5):S34-S41

21) Fonarow GC, Prystowsky EN, Lepor NE, Weyman AE, Weber MA, Watson KE, Young JJ, Kereiakes DJ, McCullough PA, Gersh BJ. Best of the ACC Scientific Session 2004. Rev Cardiovasc Med. 2004;5(2)104-129

22) Franklin BA, de Jong A, Kahn JK, McCullough PA. Fitness and mortality in the primary and

secondary prevention of coronary artery disease: Does the effort justify the outcome? Am J Med Sports 2004;6:23-27

23) McCullough PA, Franklin BA. Atherosclerosis: Conventional risk factors and cardiac

events—debunking an old myth about prevalence. Rev Cardiovasc Med. 2004;5(3):185-186

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24) Dutcher JR, McCullough PA. Commentary: Glycoprotein IIb/IIIa Inhibitors in Acute Coronary Syndromes. Evidenced Based Cardiovascular Medicine 2004;8:362-363

25) McCullough PA, Faxon DP, Fonarow GC, Jacobs AK, Watson KE, Weyman AC. Meeting

Review: Best of the AHA 2004. Rev Cardiovasc Med. 2005;6(1):33-46

26) Bashore TM, Faxon DP, Fonarow GC, Jacobs AK, Lepor NE, McCullough PA, Shah PK, Weber MA, Yeung AC. Best of the ACC Scientific Session 2005. Rev Cardiovasc Med. 2005 Spring;6(2):98-117

27) Fonarow GC, Lepor NE, McCullough PA, Jacobs AK, Bashore, TM, Faxon DP. Best of the AHA

Scientific Session 2005. Rev Cardiovasc Med. 2006 Winter;7(1):23-36

28) McCullough PA. Clinical utility of blood natriuretic peptide levels. Business Briefing: US Cardiology 2006. Touch Briefings, Touch Cardiology. www.touchcardiology.com

29) McCullough PA, Wase A. Do implantable cardioverter-defibrillators improve survival in

dialysis patients after cardiac arrest? Nature Clinical Practice Nephrology 2006; 2(2): 70-71

30) McCullough PA. Ranolazine: focusing on angina pectoris. Drugs of Today 2006, 42 (3):177-183

31) Singh PP, Nesto RW, Faxon DP, Lepor NE, Watson KE, Jacobs AK, McCullough PA. Best of

the AHA Scientific Sessions 2006. Rev Cardiovasc Med. 2007 Winter;8(1):25-35. PMID: 17401300

32) McCullough PA. Safety Concerns Trump Public Health Benefit in the Eyes of the FDA

Cardiorenal Panel. FDA Advisory Committee Did Not Recommend Approval Of Rimonabant (ZIMULTI(R)) For Use In Obese And Overweight Patients With Associated Risks Factors. www.medicalnewstoday.com GLG NewsWatch for 6/14/2007

33) Friedewald VE, Goldfarb S, Laskey WK, McCullough PA, Roberts WC. The Editor's

Roundtable: Contrast-Induced Nephropathy. Am J Cardiol. 2007 Aug 1;100(3):544-51. Epub 2007 Jun 4. PMID: 17659944

34) McCullough PA, Lepor NE. Erratum - the rosiglitazone meta-analysis. Rev Cardiovasc Med.

2007 Summer;8(3):174. PMID: 17938618 35) McCullough PA, Chronic Kidney Disease as a Cardiovascular Risk State and Considerations

for the Use of Statins. The Fats of Life, Lipoproteins and Vascular Disease Division, American Association of Clinical Chemistry, Volume XXII, No 1, 9-16 Winter 2008

36) Lepor NE, McCullough PA, Jacobs AK. Best of the AHA Scientific Sessions 2007. Rev

Cardiovasc Med. 2008 Winter;9(1):62-9. PMID: 18418310

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37) Lepor NE, McCullough PA. Best of the ACC 2010 Scientific Session. Rev Cardiovasc Med.

2010 Summer;11(3):e153-63 38) Narala KR, LaLonde TA, Hassan S, McCullough PA. Management of Chronic Coronary

Disease and Acute Coronary Syndromes in Patients with Chronic Kidney Disease. US Cardiology, 2011;8(2):123-31

39) Larsen T, Narala KR, McCullough PA. Type 4 Cardiorenal Syndrome: Myocardial

Dysfunction, Fibrosis, and Heart Failure in Patients with Chronic Kidney Disease. J Clinic Experiment Cardiol 2012, 3:4. http://dx.doi.org/10.4172/2155-9880.1000186

INVITED LECTURES: NATIONAL AND INTERNATIONAL FORUMS

L1) “The Role of Triage Angiography in Acute Coronary Syndromes.” Advances in Interventional

Cardiology. WBH and the University of Maryland, Aruba, April, 1997.

L2) “New Understandings of Anticoagulation During Unstable Angina.” Co-Chair, American College of Cardiology 47th Annual Scientific Session, Atlanta, Georgia, March 30, 1998.

L3) National Library of Medicine: The Emerging Health Information Infrastructure '99.

"Electronic Outcomes", Washington, D.C., April 28, 1999.

L4) Kansas City Southwest Clinical Society, 77th Annual Clinical Conference, Overland Park, Kansas: “Cardiac-Renal Risk: Incorporating Scientific Evidence into Your Practice,” October 29, 1999.

L5) The Health Forum, Best Practices, Chicago, Illinois. “Overview of Cardiovascular Health

Fellowship,” December 9, 1999.

L6) AHA Scientific Conference on Existing Databases: Do They Hold Answers to Clinical Questions in Geriatric Cardiovascular Disease and Stroke? “Resource Utilization Among Congestive Heart Failure (R.E.A.C.H.) Database Overview,” Washington, DC, January 27, 2000.

L7) Health Forum Cardiovascular Health Fellowship Retreat: “Cardiovascular Risk and Health,”

Colorado Springs, CO, July 20, 2000.

L8) Third Annual Center for Health Futures Advisory Board Meeting: “Congestive Heart Failure,” La Jolla, CA, August 24, 2000.

L9) Health Forum ACT Learning Collaborative Meeting: “Bridging Clinical, Community, and

Population Health Strategies,” St. Joseph, MO, September 20, 2000.

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L10) “Renal Disease as an Independent Risk Factor for Cardiovascular Disease in Diabetes,” The Nexus of Cardiovascular and Renal Disease, Duke Clinical Research Institute, Tyson’s Corner, VA, November 4, 2000.

L11) “Atherosclerosis and Heart Disease,” Winter Scientific Seminar, Missouri Society of

the American College of Osteopathic Physicians, Kansas City, MO, January 27, 2001.

L12) “Routine vs Selective Intervention in Acute Coronary Syndromes,” Tenth Annual Cardiovascular Conference at Beaver Creek, Colorado, WBH and Duke University, February 14, 2001.

L13) “Intervention in the Patient with Renal Insufficiency,” Tenth Annual Cardiovascular

Conference at Beaver Creek, Colorado, WBH and Duke University, February 16, 2001.

L14) “The Epidemic of Cardiovascular Disease and Cardiorenal Risk,” The Nexus of Cardiovascular and Renal Disease, Duke Clinical Research Institute, Tyson’s Corner, VA, February 24, 2001.

L15) “Cardiovascular Risk in Chronic Kidney Disease: Cardiorenal Risk,” Symposium on

Cardio-renal Consequences of Angiotensin II, Insights from AII Blockade, NKF Spring Clinical Meeting, Orlando, FL, April 18, 2001.

L16) Plenary Session: “Cardiac Emergencies and Cardiac Critical Care,” American College

of Chest Physicians, CHEST 2001, Philadelphia, PA, November 5, 2001.

L17) “Cardiorenal Risk,” The 33rd Annual ACC Cardiovascular Conference at Snowmass, Snowmass, Colorado, January 18, 2002.

L18) “Epidemiology of Diabetes and Its Cardiovascular Risk” Eleventh Annual

Cardiovascular Conference at Beaver Creek, Colorado, WBH and Duke University, February 14, 2002.

L19) “Late-Breaking Clinical Trials II: A Prospective, Blinded Trial of B-Type Natriuretic

Peptide as a Diagnostic Test for the Emergency Diagnosis of Heart Failure: The Breathing Not Properly (BNP) Multinational Study,” March 19, 2002, 51st Annual Scientific Session of the American College of Cardiology, Atlanta, GA.

L20) “Scope of Cardiovascular Complications in Patients with Kidney Disease.” Plenary

Session III: Reversing Cardiovascular Complications in Patients with Kidney Disease. International Society on Hypertension in Blacks: 17th International Interdisciplinary Conference on Hypertension and Related Risk Factors in Ethnic Populations, Miami, FL, June 11, 2002.

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L21) “Epidemiology: Renal—Chronic Kidney Disease.” Atherosclerotic Vascular Disease Conference, AHA, Boston, MA, July 8, 2002.

L22) “B-type Natriuretic Peptide Should be a Part of the Diagnostic Evaluation of Heart

Failure: Implications from the Breathing Not Properly (BNP) Multinational Study” International Academy of Cardiology 8th World Congress on Heart Failure—Mechanisms and Management, Washington, DC, July 15, 2002.

L23) “Epidemiology and Physiology of Radiocontrast Nephropathy and its Impact on Outcomes” Prevent the Event Transcatheter Therapeutics 2002 Satellite Symposium, Washington, DC, September 26, 2002.

L24) “Calcification or ‘Phosphication’—Controversies of Calcium Phosphate Deposition:

Invited Lecture: Coronary Calcification: A Predictor of Future Events or a Marker of Plaque Stability? American Society of Nephrology 2002 Annual Scientific Sessions Satellite Symposium, Philadelphia, PA, November 1, 2002.

L25) “Renal Insufficiency and Clinical Outcome” Cardiovascular Seminar, AHA Scientific

Sessions, Chicago, IL, November 18, 2002.

L26) “Role of BNP in the Diagnosis of Heart Failure” ACC 34th Annual Cardiovascular Conference at Snowmass, CO, January 14, 2003.

L27) “Managing the Patient with Combined Heart and Renal Failure—the Importance of

Anemia” ACC 34th Annual Cardiovascular Conference at Snowmass, CO, January 14, 2003.

L28) “The Emerging Healthcare Crisis of Obesity,” Twelfth Annual Cardiovascular Conference at Beaver Creek, CO, February 10, 2003.

L29) “BNP in the Management of Heart Failure,” Twelfth Annual Cardiovascular

Conference at Beaver Creek, CO, February 11, 2003. L30) “Contrast Nephropathy: Can it be Eliminated,” Twelfth Annual Cardiovascular

Conference at Beaver Creek, CO, February 13, 2003.

L31) “How Subtle Degrees of Renal Dysfunction Work as a Cardiac Risk Factor” First Cardiovascular Prevention Symposium: Updates and New Guidelines. AHA, Puerto Rico Chapter, San Juan, PR, March 22, 2003.

L32) “What Is the Incremental Diagnostic Value of B-Type Natriuretic Peptide in Heart

Failure?” Symposium. American College of Cardiology Scientific Sessions, 2003, Chicago, IL, April 1, 2003.

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L33) “Heart Failure Insights From Ejection Fraction” Session Co-Chair. Oral Contributions. American College of Cardiology Scientific Sessions, 2003, Chicago, IL, April 1, 2003.

L34) “Chronic Renal Insufficiency as a Vascular Risk Factor” 14th Annual Scientific Sessions

of the Society for Vascular Biology and Medicine, Chicago, IL, June 7, 2003.

L35) “Phosphate Control and Calcification from a Cardiologist’s Perspective” World Congress of Nephrology Satellite Symposium, Berlin, Germany, June 12, 2003.

L36) “Renal Disease is a Risk Factor for Cardiovascular Disease” ACC 29th Annual Tutorials

in the Tetons 2003: Update in Cardiovascular Disease, August 25-27. 2003.

L37) “Diagnosis of Congestive Heart Failure: Is BNP Needed in Every Case?” ACC 29th Annual Tutorials in the Tetons 2003: Update in Cardiovascular Disease, August 25-27. 2003.

L38) “How to Treat Combined Heart and Renal Failure with Hypertension” ACC 29th

Annual Tutorials in the Tetons 2003: Update in Cardiovascular Disease, August 25-27. 2003. L39) “Which Agents Prevent Contrast-Induced Nephropathy?” European Society of

Cardiology 2003 Symposium: Managing Patients at Risk for Contrast-Induced Nephropathy, Vienna, Austria, September 2, 2003.

L40) “Epidemiology of Contrast Nephropathy” Symposium Chair for “A Contrast in Risk:

Radiographic Imaging in the Renally Compromised Patient”, Satellite Symposium at the Transcatheter and Therapeutics Scientific Meeting, Washington, DC, September 17, 2003.

L41) “Update on Cardiovascular Risk Reduction in Acute Coronary Syndrome Patients”

14th Annual Great Wall International Congress of Cardiology, Beijing, China, October 10-13, 2003.

L42) “Renal Function and Dysfunction in Coronary Arteriography” 14th Annual Great Wall

International Congress of Cardiology, Beijing, China, October 10-13, 2003.

L43) “Interventional Cardiology 2003: Bench to Bedside and Beyond, Session III: Contrast Nephropathy: Separating the Hype from the Data. Antagonist: Contrast Nephropathy Can be Prevented.” AHA Scientific Sessions 2003, November 9, 2003, Orlando, FL.

L44) ”Reversing Diabetes and Its Consequences: Pipe Dream or Reality?” The 35th Annual

Cardiovascular Conference at Snowmass, ACC, Snowmass, CO, January 12-16, 2004.

L45) “Refining the Use of B-type Natriuretic Peptide as a Diagnostic Test in Clinical Practice” The 35th Annual Cardiovascular Conference at Snowmass, ACC, Snowmass, CO, January 12-16, 2004.

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L46) “Practical Management of Obesity for the Cardiologist: The Future of Dietary Management and Bariatric Surgery” The 35th Annual Cardiovascular Conference at Snowmass, ACC, Snowmass, CO, January 12-16, 2004.

L47) “Update from the Hypertension World: JNC 7—What’s New and How Will it Influence Practice?” Thirteenth Annual Cardiovascular Conference at Beaver Creek, Colorado, WBH and Duke University, February 9-13, 2003

L48) “The Lethal Couplet” Thirteenth Annual Cardiovascular Conference at Beaver Creek,

Colorado, WBH and Duke University, February 9-13, 2003

L49) “BNP to Differentiate Between Cardiac and Extracardiac Sources of Dyspnea” 33rd Critical Care Congress, Society of Critical Care Medicine, Orlando, Florida, February 23, 2004.

L50) “BNP Testing: Is It Ready for In-Hospital Monitoring of Therapy?” Point-of-Care

Symposium, American College of Cardiology Scientific Sessions 2004, New Orleans, LA, March 8, 2004.

L51) “Role of Brain Natriuretic Peptide Levels in Diagnosis” Natriuretic Peptides

Symposium, American College of Cardiology Scientific Sessions 2004, New Orleans, LA, March 8, 2004.

L52) “Renal Insufficiency and the Heart” Symposium Co-Chair, American College of

Cardiology Scientific Sessions 2004, New Orleans, LA, March 9, 2004.

L53) “Renal Insufficiency and Bypass Surgery” Renal Insufficiency and the Heart Symposium, American College of Cardiology Scientific Sessions 2004, New Orleans, LA, March 9, 2004.

L54) “Causes and Consequences of Contrast-Induced Nephropathy and other Major

Adverse Coronary Events” Contrast-Induced Nephropathy: Addressing the Needs of the High Risk Patient. A Satellite Symposium to the American College of Cardiology Scientific Sessions 2004, New Orleans, LA, March 9, 2004.

L55) “Chronic Kidney Disease as a Cardiovascular Risk Factor” 2nd Annual Scientific

Symposium, AHA of Puerto Rico, San Juan, PR, March 13, 2004

L56) “Modern use of Angiotensin Receptor Blockade in Cardiovascular Disease” 2nd Annual Scientific Symposium, AHA of Puerto Rico, San Juan, PR, March 13, 2004

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L57) “Chronic Kidney Disease and Cardiovascular Disease” Satellite Symposium: Impact of Anemia Correction in Cardiovascular Patients, American Society of Hypertension Annual Scientific Session, New York, NY, May 22, 2004.

L58) “Contrast-Induced Nephropathy—Clinical Anomaly or Reality” Satellite Symposium:

Selecting Contrast Media - Implications for Patient outcomes, EuroPCR 2004, Paris, France, May 26, 2004.

L59) “Contrast Nephropathy” Intervention 2004. American College of Cardiology

Nationwide Symposium, CNN Center, Atlanta, GA, June 2, 2004.

L60) “Technical Issues in Selection of the BNP Assay” Satellite Symposium of the American Association of Clinical Chemistry, Los Angeles, CA, July 28, 2004.

L61) “B-type Natriuretic Peptide in Clinical Practice” New Development in Cardiac

Biomarkers for Detection and Management of Cardiovascular Diseases, EBAC Accredited Educational Programme, in conjunction with the European Society of Cardiology 2004 Annual Congress, Munich, Germany, August 30, 2004.

L62) “Hot Topics: Renal Disease and Contrast Nephropathy—Implications for the PCI

Patient” Session Moderator, Transcatheter Cardiovascular Therapeutics 2004, September 27, 2004.

L63) “Definition and Pathophysiology of Contrast Nephropathy”, “Hot Topics: Renal

Disease and Contrast Nephropathy—Implications for the PCI Patient” Transcatheter Cardiovascular Therapeutics 2004, September 27, 2004.

L64) “Use of BNP in Clinical Practice” “Hot Topics: Clinical Utility of Biomarkers”

Transcatheter Cardiovascular Therapeutics 2004, September 28, 2004. L65) “Contrast Media, Renal Insufficiency, and Radiocontrast Nephropathy” Introduction

to Cardiac Catheterization and Indications for Percutaneous Interventions, 7th Annual Interventional Cardiology Self Assessment and Review Course, Transcatheter Cardiovascular Therapeutics 2004, September 29, 2004.

L66) “Body Weight—Optimal Targets and How Good are We in Getting There” “Drug

Combinations for Cardiovascular Disease” Duke Clinical Research Institute and U.S. Food and Drug Administration Think Tank, Washington, DC, October 8, 2004.

L67) “Does Coronary Calcification Imply Plaque Instability?” Managing Cardiovascular and

Calcium/Phosphorus Complications of CKD. Official Luncheon Symposium, Renal Week 2004, American Society of Nephrology, St. Louis, MO, October 20, 2004.

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L68) “B-type Natriuretic Peptide in the Diagnosis of Acute Heart Failure,” New Advances in the Diagnosis and Management of Acute Decompensated Heart Failure, Satellite Symposium to the AHA Scientific Sessions 2004, New Orleans, LA, November 8, 2004.

L69) “Oportunidades para Aprimoramento no Tratamiento da Insuficiencia Cardiaca,” 3rd

Congresso Brasileiro de Insuficiencia Cardiaca, II Simposio Luso-Brasileiro de Insufiencia Cardiaca, I Encontró Multiporfissional em Insuficiencia Cardiaca, II Simposio Latinoamericano de Insuficiencia Cardiaca, (Portugese) Salvador, Bahía, Brasil, November 25-27, 2004.

L70) “Peptideo Natriuretico Intravenoso-Perspectivas para Emprego na IC

Descompensada,” 3rd Congresso Brasileiro de Insuficiencia Cardiaca, II Simposio Luso-Brasileiro de Insufiencia Cardiaca, I Encontro Multiprofissional em Insuficiencia Cardiaca, II Simposio Latinoamericano de Insuficiencia Cardiaca, (Portugese) Salvador, Bahia, Brasil, November 25-27, 2004.

L71) “Nesiritide (Peptideo Natriuretico Intravenoso) uma Nova Arma no Tratamento da IC

Grave e Decompensada,” 3rd Congresso Brasileiro de Insuficiencia Cardiaca, II Simposio Luso-Brasileiro de Insufiencia Cardiaca, I Encontro Multiporfissional em Insuficiencia Cardiaca, II Simposio Latinoamericano de Insuficiencia Cardiaca, (Portuguese) Salvador, Bahia, Brasil, November 25-27, 2004.

L72) “Conferenca Magna (Keynote Address): The Cardiorenal Intersection: Crossroads to

the Future,” 3rd Congresso Brasileiro de Insuficiencia Cardiaca, II Simposio Luso-Brasileiro de Insufiencia Cardiaca, I Encontro Multiporfissional em Insuficiencia Cardiaca, II Simposio Latinoamericano de Insuficiencia Cardiaca, (Portuguese) Salvador, Bahia, Brasil, November 25-27, 2004.

L73) “Practical Use of BNP in the Diagnosis and Management of Heart Failure” Medical

Grand Rounds, Olathe Regional Medical Center, Olathe, KS, December 3, 2004.

L74) “Management of Heart and Renal Failure” The 36th Annual Cardiovascular Conference at Snowmass, ACC, Snowmass, CO, January 18, 2005.

L75) “Contrast-Induced Nephropathy” The 36th Annual Cardiovascular Conference at

Snowmass, ACC, Snowmass, CO, January 18, 2005.

L76) “Combined Heart and Kidney Failure” Cardiovascular Conference at Snowmass, Aspen, CO, January 18, 2005.

L77) “Practice Strategies and Protocols to Reduce Renal Complications” PCI:

Understanding and Managing In-Hospital Cardiac and Renal Complications, 3rd European Summit, Chantily, France, February 11, 2005.

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L78) “HDL Cholesterol: A Powerful New Therapeutic Target” 14th (Conference Chair) Annual Cardiovascular Conference at Beaver Creek, Beaver Creek, CO, February 14, 2005.

L79) “BNP-ology, is the Enthusiasm Warranted?” (Conference Chair) 14th Annual

Cardiovascular Conference at Beaver Creek, Beaver Creek, CO, February 15, 2005.

L80) “Anticoagulation for Atrial Fibrillation: Can Warfarin be Replaced?” (Conference Chair) 14th Annual Cardiovascular Conference at Beaver Creek, Beaver Creek, CO, February 18, 2005.

L81) "New Multimarker Strategies in the Diagnosis of Acute Coronary Syndromes" Satellite Symposium to the 54th Annual American College of Cardiology Scientific Sessions 2005, Orlando, FL, March 7, 2005.

L82) “Effect of Lowering LDL Level on Progression of Vascular Calcification” Reducing the

Burden of Cardiovascular Calcification in Chronic Kidney Disease, Satellite Symposium to the Renal Physicians Association Annual Meeting, Washington, DC, March 20, 2005.

L83) "Why Chronic Kidney disease is a CVD risk factor: Practical Implications in the Care of

Cardiovascular Patients" Cardiology Grand Rounds, Clinical Science Institute, Galway, Ireland, UK, May 5, 2005.

L84) “Clinical Application of B-type Natriuretic Peptide Levels in the Care of Cardiovascular

Patients” EuroLab 2005, Glasgow, Scotland, UK, May 9, 2005.

L85) “Anemia Is a Cardiovascular Risk Factor in Patients With Diabetic Nephropathy” The Kidney is a Key Link between Diabetes and Cardiovascular Disease: Managing Risk; Satellite Symposia to the Annual Scientific Sessions of the American Association of Clinical Endocrinology, Washington, DC, May 18, 2005.

L86) “CIN: Emerging Trends in Identifying and Managing the At-risk Patient”

Cardiovascular and Interventional Radiology Society of Europe (CIRSE) 2005, Nice, France, September 13, 2005.

L87) “Recent Advances in Cardiac Markers and their Clinical Role in Cardiovascular

Disease: Update of the BNP Consensus Panel Statements and Cost Effectiveness of BNP Testing” Turning Science into Caring Programme, Abbott European Laboratory Symposium, Wiesbaden-Delkenheim, Germany, October 14, 2005.

L88) “Epidemiology and Prevention of Contrast Nephropathy” Transcatheter Therapeutics

Annual Scientific Sessions, Washington, DC, October 19, 2005.

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L89) “BNP—What Does it All Mean?” Heart Failure 2005: What to Do for the Failing Left Ventricle” AHA Symposium in Conjunction with the 2005 Scientific Sessions, Dallas, TX, November 11, 2005.

L90) “How to Use Cardiac Biomarkers in Heart Failure” 2005 Annual Scientific Sessions of

the AHA, Dallas, TX, November 14, 2005, broadcasted nationally as “Best of Sessions 2005 on Wednesday, November 30 from 1:00-2:30PM EST”

L91) “Chronic Kidney Disease as a Cardiovascular Risk State: Practical Management for

the Cardiologist” St. Vincent’s Hospital, University of British Columbia, Distinguished Speakers in Cardiovascular Medicine, 2005-2006, Vancouver, BC, Canada, December, 1, 2005.

L92) “Anemia, Chronic Kidney Disease, and Cardiovascular Disease: Diagnosis, Prognosis,

and Treatment. Nephrology Grand Rounds, University of British Columbia, St. Vincent’s Hospital, Vancouver, BC, Canada, December 2, 2005.

L93) “The Deadly Triangle of Anemia, Kidney and Heart Disease: Implications for

Treatment and Management” 37th Annual Cardiovascular Conference at Snowmass, January 20, 2006, Snowmass, CO.

L94) “Anemia in Cardiovascular Patients: Diagnosis, Prognosis, and Therapy.” AHA,

Prevention VIII Conference: Kidney Disease, Hypertension, and Cardiovascular Disease, January 27, 2006, Orlando, FL.

L95) “Update on Bariatric Surgery” (Conference Chair) 15th Annual Cardiovascular

Conference at Beaver Creek, Beaver Creek, CO, February 17, 2006.

L96) “Multimarker Approach to Chest Pain.” Satellite Symposium to the Annual Scientific Sessions of the American College of Cardiology, March 11, 2006, Atlanta, GA.

L97) ” Preventing Contrast Nephropathy: What Works?” American College of Cardiology

Annual Scientific Sessions (ACC.06 and the i2 Summit 2006), March 14, 2006, Atlanta, GA.

L98) “Consensus statements on strategies to reduce the risk of CIN.” Satellite Symposium Society for Cardiac Angiography and Intervention 29th Annual Scientific Sessions (Symposium Chair): Consensus Statements on Contrast-Induced Nephropathy (CIN): Report of an International, Multidisciplinary Panel, Chicago, IL, May 11, 2006.

L99) “Contrast-induced nephropathy: identifying and managing the patient at risk.” Euro

PCR 2006 Satellite Symposium: The Underestimated Impact of Contrast Media on Patient Outcomes in PCI (Symposium Chair), Paris, France, May 27, 2006.

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L100) “Debate: Acute Decompensated Heart Failure--Biomarker will suffice” 17th Annual Scientific Sessions of the American Society of Echocardiography, Baltimore, MD, June 6, 2006.

L101) “Heart and Kidney: Clinical Impact of Contrast Media” Update on Cardiovascular

Disease 2006, Casa Di Cura Montevergine, Napoli Castel Dell’Ovo, Naples, Italy, June 19, 2006.

L102) “Cardiovascular Disease in CKD: Where Does Calcium Fit In?” Satellite Symposia:

Current Strategies for the Management of Hyperphosphatemia in End-Stage Renal Disease. European Renal Association/European Dialysis and Transplantation Association Annual Scientific Meeting, Glasgow, Scotland, July 17, 2006.

L103) “Applications of BNP in Cardiovascular Disease” Satellite Symposia: New and

Evolving Markers for Cardiovascular Disease: Myeloperoxidase (MPO) and BNP. American Association of Clinical Chemistry Annual Meeting, Chicago, IL, July 26, 2006.

L104) “Clinical Applications of B-type Natriuretic Peptide Testing” Clinical Biochemistry

Satellite Symposium: The Role of Biochemical Markers in Clinical Cardiology, Sponsored by the Australasian Association of Clinical Biochemists at the 54th Annual Scientific Meeting of the Cardiac Society of Australia and New Zealand, Canberra, Australia, August 4, 2006.

L105) “Update on BNP in the Management of Heart Failure” 54th Annual Scientific Meeting

of the Cardiac Society of Australia and New Zealand, Canberra, Australia, August 6, 2006.

L106) “Update on BNP in the Management of Heart Failure” Cardiology Grand Rounds, Royal North Shore Hospital, Sydney, Australia, August 7, 2006.

L107) “Contrast-Induced Nephropathy: Identifying and Managing the Patient at Risk”

Advances in Contrast-Enhanced Imaging: Improving Outcomes and Reducing Risks of Iodinated Contrast (Chairman), a CME Satellite Symposium at the Transcatheter Therapeutics 2006 Conference, Washington, DC, October 24, 2006.

L108) “Cardiorenal Syndrome: Etiology, Therapy, and Prognosis” Unresolved Issues in

Heart Failure, Cardiovascular Seminars, 2006 Annual Scientific Sessions of the AHA, Chicago, IL, November 14, 2006

L109) “Prevention and Management of CAD in CKD” Coronary Artery Disease in CKD:

Updating the Pathophysiology and Management. Official Symposium of the American Society of Nephrology, Sand Diego, CA, November 16, 2006.

L110) “Pharmacologic Prevention of Sudden Death in Dialysis Patients” Sudden Death in

Hemodialysis Patients: Towards Prevention. American Society of Nephrology Renal Week 2007, San Diego, CA, November 17, 2006.

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L111) “Contrast Nephropathy: Finding Consensus on a Rational Approach” Radiology

Grand Rounds, Hôpital Notre-Dame, University of Montreal, Canada, November 23, 2006.

L112) “Contrast Nephropathy: Finding Consensus on a Rational Approach” Radiology Grand Rounds, Hôpital St-Luc, University of Montreal, Canada, November 23, 2006.

L113) “Cardiorenal Syndrome and Anemia” 3rd Annual Heart Failure University (HFU)

Cardiovascular Fellows Program, Los Angeles, CA, December 2, 2006. L114) “Implications of Age-Related Decline in Renal Function” 16th Annual Cardiovascular

Conference at Beaver Creek, Beaver Creek, CO, February 12, 2007. L115) “Using BNP in Your Practice: Pearls and Pitfalls” 16th Annual Cardiovascular

Conference at Beaver Creek, Beaver Creek, CO, February 15, 2007. L116) “Consensus Panel Findings on Contrast Nephropathy” 16th Annual Cardiovascular

Conference at Beaver Creek, Beaver Creek, CO, February 16, 2007. L117) “Measuring BNP in ACS,” American College of Cardiology Scientific Sessions Satellite

Symposium, “ACS & Biomarkers: From Molecules to Patient Management”, New Orleans, LA, March 24, 2007.

L118) “Anemia Correction and CVD Trials” “Ask the Experts” clinicaltrialresults.org,

American College of Cardiology Scientific Sessions, New Orleans, LA, March 26, 2007. L119) “CKD and CVD: Interaction and Risk Factors”, Kidney Disease: The Unrecognized

Silent Killer, NKF 2007 Scientific Meetings, Orlando, FL, April 11, 2007. L120) “Contrast-Induced Nephropathy: A Meta-Analyses of the Renal Safety of Iodixanol”

Special Lecture for the Radiological Society of the Republic of China, National Yang-Ming University, School of Medicine, Taipei, Taiwan, May 4, 2007.

L121) “Contrast-Induced Nephropathy: A Meta-Analyses of the Renal Safety of Iodixanol”

Annual Meeting of Kaohsiung Society of Radiology, Chang Gung Memorial Hospital, Kaohsiung Hsien, Taiwan, May 5, 2007.

L122) ”Meta-Analyses of the Renal Safety of Iodixanol”, Plenary Session, 15th Annual

Scientific Congress of the Hong Kong College of Cardiology, Hong Kong, SAR, May 6, 2007. L123) “Contrast-Induced Nephropathy: A Meta-Analyses of the Renal Safety of Iodixanol”

Cardiology Special Lecture, 12th Department of Cardiology, Beijing AnZhen Hospital, Beijing, Peoples Republic of China, May 7, 2007.

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L124) “Prevention of CIN during PCI in Diabetic Patients: Proposal of a Guideline" (Prevencion del Fracaso Renal Inducido por Contraste en Pacientes Diabeticos Sometidos a Intervencionismo Coronario: Propestuesta de un Protocolo Actuacion), Optimizacion del Tratamiento de Revascularizacion Percutanea en Pacientes Diabeticos, TEAM (Terapia Endovascular & Miocardica), Hospital del Mar, Barcelona, Spain, May 11, 2007.

L125) “Acute Kidney Injury from Iodinated Contrast: Findings from an International Panel,”

Hungarian Society of Cardiology Annual Scientific Meeting (Magyar Kardiologusok Tarsasaga Tudomanyos Kongresszusa) Balatonfured, Hungary, May 12, 2007.

L126) “Which Types and Which Amount of Physical Activities to Achieve and Maintain a

Healthy Body Weight?” 4th Metabolic Syndrome, Type II Diabetes, and Atherosclerosis Congress (MSDA), 2007, Lisbon, Portugal, May 19, 2007.

L127) “The Role of BNP in Patients with Shortness of Breath,” Laboratory Diagnostic

Technologies for Patients with Shortness of Breath, Satellite Symposium to the American Association of Clinical Chemistry Annual Scientific Meeting, San Diego, CA, July 18, 2007.

L128) “Acute Kidney Injury after Contrast: A Serious Problem by Any Name”,

Hemodynamics, Electrolytes, Acute Kidney Injury: Novel Considerations in Contrast Selection, Transcatheter Cardiovascular Therapeutics 2007 Annual Meeting Satellite Symposium, Washington, DC, October 23, 2007.

L129) “Vascular Calcification: Myth versus Realty: A Cardiologist's Perspective,” Changing

Paradigms: Evolving Bone and Mineral Metabolism Treatment in CKD, An American Society of Nephrology 2007 Official Symposia, San Francisco, CA, November 3, 2007.

L130) “Contrast-Induced Nephropathy” Cardiology Grand Rounds, Auckland City Hospital,

Auckland, New Zealand, November 22, 2007. L131) “Practical Use of Natriuretic Peptides in Cardiovascular Disease” North Shore

Hospital- Waitemata Health, Takapuna, Auckland, New Zealand, November 22, 2007. L132) “Practical Use of Natriuretic Peptides in Cardiovascular Disease” Waikato Hospital,

Hamilton, New Zealand, November 23, 2007. L133) “Practical Use of Natriuretic Peptides in Cardiovascular Disease” Wakefield Hospital,

Adelaide, Australia, November 23, 2007. L134) “Clinical Utilization of Cardiac Troponin and Natriuretic Peptides in ACS and CHF”

Satellite Symposium to Australasian Emergency Meeting (ACEM), Gold Coast, Brisbane, Australia, November 27, 2007.

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L135) “Clinical Utilisation of Cardiac Troponin and Natriuretic Peptides in ACS and CHF: Part 1: Congestive Heart Failure, Part 2: Acute Coronary Syndrome, Part 3: Cardio-Renal Syndrome, Kuala Lumpur, Malaysia, November 29, 2007.

L136) “Multimarker Strategies in the Management of Cardiovascular Emergencies,” YMCA

for Dr. H.F.Ho, Queen Elizabeth Hospital, Hong Kong, SAR, November 30, 2007. L137) “Practical Management of Cardiovascular Disease in Patients with Kidney Disease”

Williamsburg, Virginia for the 34th Annual Williamsburg Conference on Heart Disease, Williamsburg, VA, December 3, 2007.

L138) “New Cardiovascular Drugs” 17th Annual Cardiovascular Conference at Beaver

Creek” Avon, CO, February 12, 2008. L139) “New Insights into Atherosclerosis and Global CVD Risk,” 17th Annual Cardiovascular

Conference at Beaver Creek” Avon, CO, February 12, 2008. L140) “Plenary 2 : Mini-Symposia: Acute Kidney Injury (AKI): Pathophysiology: Contrast

Nephropathy: Epidemiology and Prognosis” 13th Annual International Conference on Continuous Renal Replacement Therapies, San Diego, CA, February 28, 2008.

L141) “Heart Failure and Cardio-Renal Syndrome 1: Pathophysiology” 13th Annual

International Conference on Continuous Renal Replacement Therapies, San Diego, CA, February 29, 2008.

L142) “Hemodynamic Monitoring: Principles and Practice” 13th Annual International

Conference on Continuous Renal Replacement Therapies, San Diego, CA, February 29, 2008. L143) “Cardiovascular Calcification, Potential Strategies in Minimizing Cardiovascular

Disease in CKD”, Satellite Symposia at the 57th ACC Annual Scientific Sessions, Chicago, IL, March 30, 2008.

L144) “Emergency Evaluation of Chest Pain: Building a Better Mousetrap” Olathe Medical

Center Annual Heartbeat Symposium, Olathe, KS, April 4, 2007. L145) “Interventions and CVD Interactions in Diabetics with Proteinuria” Satellite Symposia

(Chairman) Chronic Kidney Disease Interventions: Improving CKD and CVD Outcomes” NKF Clinical Meeting 2008, Dallas, TX, April 5, 2008.

L146) “Shifting Paradigms in PCI: Controversial Issues in High-Risk Patients” International

Symposium (Chairman), Barcelona, Spain, April 10, 2008.

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L147) “Success in Identifying Heart Failure” Satellite Symposia “Managing CVD: What Every Internist Needs to Know” Annual Scientific Sessions of the American College of Physicians, Washington, DC, May 14, 2008.

L148) “Cardiovascular Calcification in Patients with Chronic Kidney Disease” Satellite

Symposia “Cardiovascular Disease in CKD: Strategies for Minimizing Mortality” Annual Scientific Sessions of the American College of Physicians, Washington, DC, May 15, 2008.

L149) “Clinical Trial Designs in Contrast Induced Acute Kidney Injury,” Third Annual AKIN

Conference on Research Initiatives in AKI, Bethesda, MD, June 10-12, 2008. L150) “Neutrophil Gelatinase Associated Lipocalin (NGAL)” on Behalf of Inverness Medical,

Third Annual AKIN Conference on Research Initiatives in AKI, Bethesda, MD, June 10-12, 2008.

L151) “Practical Strategies to Manage Contrast-induced Acute Kidney Injury (CI-AKI): The

Evidence and the Controversy” Radiological Society of Taiwan, Taipei, Taiwan, July 17, 2008.


Evidence and the Controversy” Radiological Society of Taiwan, Kaushiung, Taiwan, July 18, 2008.


Evidence and the Controversy” Contrast-Induced Nephropathy Symposium, Professor Yalin Han, MD, Chairwoman of Military Cardiology Society of China, Shenyang, China, July 20, 2008.

L154) Cardiology Teaching Rounds, with Professor Runlin Gao, Beijing Fuwai Hospital,

Beijing, China, July 21, 2008. L155) Cardiology Teaching Rounds, with Professor Yujie Zhou, Beijing Anzhen Hospital,

Beijing, China, July 21, 2008. L156) Cardiology Teaching Rounds with Professor Yundai Chen, General Hospital of

Military, Peoples Liberation Army, Beijing, China, July 21, 2008. L157) “Practical Strategies to Manage Contrast-induced Acute Kidney Injury (CI-AKI): The

Evidence and the Controversy” Contrast-Induced Nephropathy Symposium, Contrast-Induced Nephropathy Symposium, Professor Runlin Gao, Chairman of Chinese Cardiology Society, Beijing, China, July 22, 2008.K

L158) “New Insights on Accelerated Vascular Calcification in Patients with Kidney Disease”

Plenary Session: Ischemic Heart Disease/Risk Assessment/New Treatment Strategies”

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International Academy of Cardiology 14th World Congress on Heart Disease, Annual Scientific Sessions, Toronto, Ontario, Canada, July 29, 2008.

L159) “Cardiorenal Syndrome: the Diagnostic Value of Brain Natriuretic Peptide and

Neutrophil Gelatinase Associated-Lipocalin in Interventional Cardiology,” Cardiovascular Biomarkers which Enhance Clinical Practice in Emergency Medicine and Cardiology: the State of the Art for Markers of Necrosis, Hemodynamic Stress and Cardiorenal Syndrome, Satellite Symposium to the European Society of Cardiology Annual Scientific Sessions, Munich, Germany, September 2, 2008.

L160) “Diagnosis and Management of Diabetes, Hypertension, and Acute Dyspnea,” 2008

CVD and CKD Intersection Consensus Conference, Chicago, IL, September 26, 2008. L161) “Chronic Kidney Disease and Contrast Nephropathy (Contrast-Induced Acute Kidney

Injury [CI-AKI]): From Prognostic Scores to the Latest Preventive Strategies” Complex Patients, Complex Lesions, 20th Annual Transcatheter Therapeutics Conference, Washington, DC, October 14, 2008.

L162) “Chronic Kidney Disease: a CHD Risk Equivalent” 2008 Cardiometabolic Health

Congress, Harvard Medical School, Boston, MA, October 19, 2008. L163) “Hyperphosphatemia as a Cardiovascular Risk Factor” Nephrology Conference, The

Ottawa Hospital, Ottawa, Ontario, Canada, October 28, 2008. L164) “Cardiovascular Calcification in Patients with Chronic Kidney Disease” Nephrology

Division-Wide Conference, The Ottawa Hospital, Ottawa, Ontario, Canada, October 28, 2008.

L165) “Hyperphosphatemia and CVD Risk,” Management of Hyperphosphatemia Across the

Continuum of CKD, American Society of Nephrology Satellite Symposium, Philadelphia, PA, November 8, 2008.

L166) “Cardiovascular Calcification” Nephrology Grand Rounds, Humber River Regional

Hospital, Toronto, Ontario, Canada, December 9, 2009. L167) “Cardiovascular Calcification” Nephrology Grand Rounds, St. Joseph’s Hospital,

Toronto, Ontario, Canada, December 9, 2009. L168) “Critical Concepts in the Progression of Atherosclerosis” 18th Annual Cardiovascular

Conference at Beaver Creek, Beaver Creek, CO, February 9, 2009. L169) “New Molecular Targets in the Treatment of Atherosclerosis” 18th Annual

Cardiovascular Conference at Beaver Creek, Beaver Creek, CO, February 9, 2009.

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L170) “Sudden Cardiac Death in Patients with Renal Disease” 18th Annual Cardiovascular Conference at Beaver Creek, Beaver Creek, CO, February 12, 2009.

L171) “Cardiovascular and Renal Implications of Contrast Media” Radiology Grand Rounds,

The Kingston Hospital, Queens University School of Medicine, Kingston, Ontario, Canada, March 3, 2009.

L172) “Recent Evidence into the Pathophysiology of Cardiovascular Calcification in Chronic

Kidney Disease,” NKF Symposium 2009 Spring Clinical Meetings, “Exploring Recent Evidence Related to Cardiovascular Calcification and Chronic Kidney Disease”, Nashville, TN, March 27, 2009.

L173) “Chronic Kidney Disease: Implications For Patients With CAD” Managing the High Risk

Coronary Patient, I2 Summit, American College of Cardiology Annual Scientific Sessions, Orlando, FL, March 30, 2009.

L174) “BNP and Cardiovascular Disease” Cardiology Grand Rounds, Hospital PróCardíaco,

Rio deJaniero, Brasil, April 14, 2009. L175) “Acute Cardiac Effects of Marathon Running” Special Guest Lecture, CLINIMEX -

Clínica de Medicina do Exercício, Rio deJaniero, Brasil, April 14, 2009. L176) “Interface entre doenca renal e cardiovascular: o rim mata o coracao ou o coracao

mata o rim? Da para evitar esse extermino?” Terapeutica Cardiovascular International, Hospital Espanhol, Salvador, Brasil, April 17, 2009.

L177) “A angiotomografia coronaria deve ser empregada em todo paciente com do toracica

de risco baixo-moderado?” Terapeutica Cardiovascular International, Hospital Espanhol, Salvador, Brasil, April 17, 2009.

L178) “Conferencia Internacional: Opportunidades para aperfeicoar o tratamento da

insuficiencia cardiaca avancada/descompensada” Terapeutica Cardiovascular International, Hospital Espanhol, Salvador, Brasil, April 17, 2009.

L179) “Invasive Versus Non-invasive Coronary Angiography: Guidelines for Achieving

Optimal Outcomes” Annual Scientific Sessions of the Society for Cardiac Angiography and Intervention, Las Vegas, NV, May 7, 2009.

L180) “Cardiorenal Syndrome” Moderator, American Society of Nephrology Annual

Scientific Sessions, Renal Week 2009, San Diego, CA, October 29, 2009. L181) “The Creatinine Changes: Now What?” Cardiorenal Syndromes, Annual Scientific

Sessions, AHA, Orlando, FL, November 16, 2009.

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L182) “Cardiorenal Syndromes: Strategies for Success” 19th Annual Cardiovascular Conference at Beaver Creek, Avon, CO, February 6-11, 2010.

L183) “Cardiomyopathy of Obesity” 19th Annual Cardiovascular Conference at Beaver

Creek, Avon, CO, February 6-11, 2010.

L184) “Why Does Atherosclerosis Calcify: Clinical Implications” 19th Annual Cardiovascular Conference at Beaver Creek, Avon, CO, February 6-11, 2010.

L185) “Prevention Trials in AKI” 15th International Conference on Continuous Renal

Replacement Therapies (CRRT: 2010) Scientific Meeting, Del Coronado, CA, February 24, 2010.

L186) “Cardiology Trials” 15th International Conference on Continuous Renal Replacement

Therapies (CRRT: 2010) Scientific Meeting, Del Coronado, CA, February 24, 2010. L187) “Contrast Nephropathy: Prevention and Management” 15th International

Conference on Continuous Renal Replacement Therapies (CRRT: 2010) Scientific Meeting, Del Coronado, CA, February 26, 2010.

L188) “Lipoprotein-Associated Phospholipase A2 (Control#: 4599)” Symposium: Do New

Markers & Genomics Enhance Risk Prediction? Annual Scientific Sessions of the ACC, Atlanta, GA, March 15, 2010.

L189) “New Insights Into the Role of Heart-Kidney Interactions in the Cardiorenal

Syndrome” (Control#: 16660) Symposium: Recognition and Management of the Cardiorenal Syndrome in Advanced Heart Failure, Annual Scientific Sessions of the American College of Cardiology, Atlanta, GA, March 15, 2010.

L190) “B-Type Natriuretic Peptides in Cardiorenal Syndromes” 5th Annual Turning Science

into Caring Symposium, Wiesbaden, Germany, March 25, 2010.

L191) “CKD and CVD Interaction in KEEP” KEEP Update: the Common Soil of CKD and CVD, NKF Spring Clinical Meetings, Orlando, FL, April 16, 2010.

L192) “Cardio Renal Intersection, Crossroads to the Future - Novel Coronary Risk Factors"

NKF Spring Clinical Meetings, Orlando, FL, April 16, 2010.

L193) “Diagnostic Workup of suspected heart disease in CKD” NKF Spring Clinical Meetings, Orlando, FL, April 17, 2010.

L194) “BNP: Beyond Heart Failure (BNP más allá de la insuficiencia cardiaca)”, XIX Chile

2010 Congreso Latinoamericano de Bioquimica Clinica, XVI Congreso Chileno de Quimica

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Clinica, Biomarcadores en Enfermedades Cario-Renales COLABIOCLI 2010, Santiago del Chile, April 21, 2010.

L195) “Prevention of Cardiorenal Syndromes”, 19th International Vicenza Course on Critical

Care Nephrology, Vicenza, Italy, June 10, 2010.

L196) “La Pandemia de la Obesidad: Que podemos hacer aquí y ahora” “Importancia de la Evaluación previa y el monitoreo cardiaco en rehabilitación cardiaca” “Ergoespirometria: Diagnostico e implicaciones terapéuticas,” Sociedad Columbiana de Cardiologica y Ciruga Cardiovacular Fundacion Columbiana del Corazon Comite de Prevencion y Rebabilitacion Cardiovascular Dia Mundial del Corazon, Santa Marta, Columbia, September 25, 2010.

L197) “CKD: A CHD Equivalent” 2010 Cardiometabolic Health Congress (CMHC), Boston

MA, October 22, 2010.

L198) “Treatment Disparities in Patients with Acute Coronary Syndromes and Kidney Disease” AHA Scientific Sessions 2010, Chicago, IL, November 13, 2010.

L199) “Integration of Advanced Information Technology into Nephrology Practice”

Moderator, at the American Society of Nephrology, Denver, CO, November 21, 2010.

L200) “Cardiorenal Syndromes” Special Lecture, Mansoura Nephrology and Urology Center, Mansoura, Egypt, November 29, 2010.

L201) “Neutrophil Gelatinase Associated Lipocalin.” Al Mokhtabar Laboratories, Cairo,

Egypt, December 1, 2010.

L202) “Cardiorenal Syndromes” ACC Williamsburg Conference, Williamsburg, VA, December 5, 2010.

L203) “Micronutrients and Cardiorenal Disease: Insights into Novel Assessments and

Treatment” 13th International Conference on Dialysis, Advances in CKD 2011, Miami, FL, January 26, 2011.

L204) “Managing High Risk Patients in a i2 Spotlight entitled Cardiac Care Team Spotlight:

Approaches for CAD Management” American College of Cardiology 60th Annual Scientific Session and i2 Summit 2011, April 2, 2011, in New Orleans, LA.

L205) “Lipid Management in Patients with Renal Insufficiency in a ACC Symposium entitled

Lipid Management in Special Populations” American College of Cardiology 60th Annual Scientific Session and i2 Summit 2011, April 2, 2011, in New Orleans, LA.

L206) “KEEP Symposium 2011: KEEP A New Longitudinal Dimension for a New Decade”

NKF Spring Clinical Meetings, April 29, 2011, Las Vegas, NV.

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L207) “Disparities of Treatment for ACS and Heart Failure in CKD Patients” 20th

International Vicenza Course on Hemodialysis and CKD, June 8, 2011, Vicenza, Italy.

L208) “AKI: Can We Prevent It?” 20th International Vicenza Course on Hemodialysis and CKD, June 9, 2011, Vicenza, Italy.

L209) “Measuring Natriuretic Peptides in Acute Coronary Syndromes” American

Association of Clinical Chemistry Annual Meeting, Atlanta, GA, July 26, 2011.

L210) “Biomarkers in Stable Angina and Microvascular Dysfunction”, Emerging Role of Biomarkers in Cardiorenal Syndrome and Acute Coronary Syndrome: Diagnosis Stratification and Management, Siena Italy, September 2, 2011.

L211) “Cardiorenal Syndrome Definition and Scope: Cardiac Perspective” 28th National

Congress of Nephrology, Hypertension, Dialysis, and Transplantation, Antalya, Turkey, October 20, 2011.

L212) “Targeted Hypertension Management for Optimal Cardiorenal Outcomes” 28th

National Congress of Nephrology, Hypertension, Dialysis, and Transplantation, Antalya, Turkey, October 22, 2011.

L213) “The KEEP Experience” 3rd International Symposium on Albuminuria – The

Prognostic Role of Albuminuria: Impact on Kidney and Cardiovascular Outcomes, Groningen, Netherlands, December 1, 2011.

L214) “Cardiorenal Syndromes” Cardiology Guest Lecture, University of Chicago, Pritzker

School of Medicine, Chicago, IL, January 18, 2012.

L215) “Diagnosis of Cardiovascular Disease in CKD” 14th international conference on dialysis, advances in CKD 2012, Palm, Harbor, FL, January 26, 2012

L216) “Acute Kidney Injury Guidelines” KDIGO Clinical Practice Conference: KDIGO

Guidelines on Acute Kidney Injury, Glomerulonephritis, and Anemia, Shanghai, China, February 5, 2012

L217) “Galectin-3: A Novel Blood Test for the Evaluation and Management of Heart

Failure” Cardiology Grand Rounds, University of Arkansas for Medical Sciences, Little Rock, Arkansas, February 8, 2012

L218) “Contrast-Induced Acute Kidney Injury” 17th Annual CRRT 2012, Acute Kidney Injury

Controversies, Challenges, and Solutions, San Diego, CA February 15, 2012

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L219) “Recent Trials in the Prevention of Contrast-Induced AKI: Importance of Emerging Biomarkers” 17th Annual CRRT 2012, Acute Kidney Injury Controversies, Challenges, and Solutions, San Diego, CA February 17, 2012

L220) “Role of Galectin-3 in Heart Failure” Joint American Association of Cardiologists of

Indian Origin and ACC Dinner Symposium, American College of Cardiology Scientific Sessions 2012, Chicago, IL, March 25, 2012

L221) “Bariatric Surgery: A Cure for Obesity?” American College of Cardiology Scientific

Sessions 2012, Joint Symposium of the American Association of Clinical Endocrinologists and the ACC: Cardiologists as Endocrinologists – Emerging Management of the Diabetic Patient, Chicago, IL, March 26, 2012

L222) “Practical Management of Obesity for the Cardiologist” 48th Annual Robert M.

Jeresaty Cardiovascular Symposium, Hartford, CT, May 3, 2012 L223) “Prevention of Cardiovascular Events: Beyond Statins” 48th Annual Robert M.

Jeresaty Cardiovascular Symposium, Hartford, CT, May 3, 2012 L224) “Contrast Media and Patient Safety: The Clinical Impact” Swiss Congress of Radiology,

Zurich, Switzerland, May 31, 2012 L225) “Importance of Methodological Rigor in CI-AKI Meta-Analyses” 48th Congresso

Nazionale Italian Society of Radiology (SIRM), Torino, Italy, June 2, 2012

L226) “Chronic Kidney Disease and Heart Failure” 2012 Cardiometabolic Health Congress (CMHC) Boston, MA, October 12, 2012

L227) “Chronic Kidney Disease and Acute Myocardial Infarction” CKD a Recipe for CVD

Disaster, Kidney Week, American Society of Nephrology, San Diego, CA, October 30, 2012

L228) “Epidemiology and Pathophysiology of Coronary Artery Disease in Chronic Kidney Disease” Scientific Sessions 2012, AHA, Los Angeles, CA, November 5, 2012

L229) “The Cardiorenal Syndrome” Acute Dialysis Quality Initiative 11: Cardiorenal

Syndromes, Venice, Italy, November 30, 2012

L230) “Cardiorenal Syndromes” Cardiology Grand Rounds, University of Missouri School of Medicine, Columbia, MO, December 20, 2012

L231) “Diagnosis and Management of Coronary Disease in Patients with Kidney Disease”

Internal Medicine Grand Rounds, University of Missouri School of Medicine, Columbia, MO, December 20, 2012

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L232) “The Hypertension Epidemic: Are We Any Further Ahead?” 22nd Annual Cardiovascular Conference at Beaver Creek, Avon, CO, February 9-16, 2013

L233) “Cardiorenal Syndromes: The Cardiac Perspective” Inaugural Cardio Renal Society of

America (CRSA), 14th Annual Southwest Nephrology Conference (SWNC), Chandler, AZ, March 2, 2013

L234) "Managing Hyponatremia in Cardiorenal Syndromes" Satellite Symposia to the NKF

Spring Clinical Meetings, Orlando, FL, April 3, 2013

L235) “Session Title: Debate: To Screen or Not to Screen for CKD--PRO? NKF Spring Clinical Meetings, Orlando, FL, April 5, 2013

L236) “Galectin-3: A Novel Biomarker for the Assessment and Management of Heart

Failure” Heart Failure Conference, University of Pittsburgh Medical Center, Pittsburgh, PA, May 28, 2013

L237) “The Kidney in Heart Failure” 31st International Vicenza Course on Critical Care

Nephrology, June 11-14, 2013, Vicenza, Italy

L238) “Contrast-Induced Acute Kidney Injury” 31st International Vicenza Course on Critical Care Nephrology, June 11-14, 2013, Vicenza, Italy

L239) “Novel Biomarkers in the Prognosis and Management of Heart Failure” BUMC

Medicine Grand Rounds, August 20, 2013, Dallas, TX

L240) “Cardiorenal Syndromes: New Insights into Combined Heart and Kidney Failure” Cardiology Grand Rounds, University of Virginia Medical Center, August 26, 2013, Charlottesville, VA

L241) “Major Advances in the Treatment of Atherosclerosis: New Options for Patients with

Familial Hypercholesterolemia and Those Intolerant to Conventional Lipid Lowering Therapy” Cardiology Update, University of Missouri School of Medicine, September 14, Columbia, MO

L242) “Keynote Address: Recent Advances in the Assessment of Acute Kidney Injury with

Neutrophil Gelatinase Associated Lipocalin” 47th Brazilian Congress of Clinical Pathology and Laboratory Medicine, September 23, 2013, Sao Paulo, Brazil.

L243) “Advancements in Cardiometabolic Risk Assessment: Expert Analysis of Recent

Evidence and Outcomes” 2013 Cardiometabolic Health Congress, October 2, 2013, Boston, MA.

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L244) “Keynote Address: Cardiorenal Syndromes: New Insights to Patients with Combined Heart and Kidney Failure” Fourth Italian Great Network Congress, Focus on Innovation and Translational Research in Emergency Medicine, Sapienza Universita di Roma, October 14-18, 2013, Rome, Italy.

L245) “Practical Experience with Galectin-3” Fourth Italian Great Network Congress, Focus

on Innovation and Translational Research in Emergency Medicine, Sapienza Universita di Roma, October 14-18, 2013, Rome, Italy.

L246) “Using Novel Biomarkers in the Assessment and Management of Heart Failure” Bon

Secours Cardiovascular Conference, October 25, 2013, Williamsburg, VA

L247) “Detection and Consequences of Iron Deficiency Anemia in CKD Patients” Session Title: The Role of Iron in the Optimization of Anemia Management in CKD, American Society of Nephrology, Kidney Week, November 9, 2013, Atlanta, GA

L248) “Bench to Bedside: What Happens to the Physiologic Systems After an Acute Bout of

High Intensity/Volume Exercise?” Session Title: Cardiovascular Seminar entitled Potential Cardiotoxicity of Extreme Endurance Exercise, Annual Scientific Sessions of the AHA, November, 20, 2013, Dallas, TX.

L249) “Atrasentan for the treatment of diabetic nephropathy: how to control the risk of

heart failure?” Session Title: “Lessons Learned from First Post FDA Guidance Case Studies of Diabetes CV Outcomes Trials, 10th Global CardioVascular Clinical Trialists (CVCT) Forum, December 7, 2013, Paris, France.

L250) “Reflection: Biomarker-based modeling tools: safer drugs and faster development?”

A workshop initiated by the TI-Pharma Escher project for academia, industry, and the European Medicines Agency, January 24, 2014, Amsterdam, the Netherlands.

L251) “Focus on lipids: HDL and Its Associated Lipoproteins in Cardiac and Renal Disease”

Changing Paradigms in Acute Kidney Injury: From Mechanisms to Management Sponsored by UAB/UCSD O’Brien Center for AKI Research, 19th International Conference on Advances in Critical Care, CRRT 2014, International Society of Nephrology, Acute Kidney Injury Network, March 4-7, 2014, San Diego, CA.

L252) “Cardiac and Renal Fibrosis in Chronic Cardiorenal Syndromes” Targeting Recovery

from Acute Kidney Injury:, 19th International Conference on Advances in Critical Care, CRRT 2014, International Society of Nephrology, Acute Kidney Injury Network, March 4-7, 2014, San Diego, CA.

L253) “Statins for AKI: Friend or Foe” Controversies in Critical Care Nephrology:, 19th

International Conference on Advances in Critical Care, CRRT 2014, International Society of Nephrology, Acute Kidney Injury Network, March 4-7, 2014, San Diego, CA.

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L254) “Managing Heart Failure and Cardiorenal Syndrome” Workshop, 19th International

Conference on Advances in Critical Care, CRRT 2014, International Society of Nephrology, Acute Kidney Injury Network, March 4-7, 2014, San Diego, CA.

L255) “ST2: A Novel Biomarker in the Assessment and Management of Heart Failure” 2nd

Annual Cardio Renal Society of America (CRSA), 15th Annual Southwest Nephrology Conference (SWNC), Ft. McDowell, AZ, March 8, 2014.

L256) “Cardiac and Renal Fibrosis in Chronic Cardiorenal Syndromes” 2nd Annual Cardio

Renal Society of America (CRSA), 15th Annual Southwest Nephrology Conference (SWNC), Ft. McDowell, AZ, March 8, 2014.

L257) “New Approaches to the Management of Cardiorenal Syndromes” 2nd Annual Cardio

Renal Society of America (CRSA), 15th Annual Southwest Nephrology Conference (SWNC), Ft. McDowell, AZ, March 8, 2014.

L258) “My New Favorite Biomarker: Galectin-3” 2014 UCSD Biomarkers in Clinical Practice

Symposium, La Jolla, CA, April 5, 2014.

L259) “Changing Profile of Chronic Hyperkalemia” NKF Spring Clinical Meetings, Las Vegas, NV, April 24, 2014.

L260) “The Next Generation of Screening for Kidney Disease” NKF Spring Clinical Meetings,

Las Vegas, NV, April 25, 2014.

L261) “Cardiorenal Syndromes” Cardiology, Diabetes & Nephrology at the Limits, Royal College of Physicians, London, UK, April 26, 2014.

L262) “Acute Cardiorenal Syndromes: New Insights into Combined Heart and Kidney

Failure” Actual Problems of Extracorporeal Blood Purification in Intensive Care, Russian Scientific Society of Specialists in Extracorporeal Blood Purification, Bakoulev Scientific Center for Cardiovascular Surgery of the Russian Academy of Medical Sciences, Moscow, Russia, May 22, 2014.

L263) "Fibrosis in the Heart and Kidneys in the Pathogenesis of Chronic Cardiorenal

Syndromes" Actual Problems of Extracorporeal Blood Purification in Intensive Care, Russian Scientific Society of Specialists in Extracorporeal Blood Purification, Bakoulev Scientific Center for Cardiovascular Surgery of the Russian Academy of Medical Sciences, Moscow, Russia, May 23, 2014.

L264) “Hyperkalemia: Old Foe with New Faces” 51st European Renal Association – European

Dialysis and Transplantation Association Congress, Amsterdam, the Netherlands, June 2, 2014.

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L265) “Contrast Induced Complications in the Cath Lab” Transcatheter Cardiovascular

Therapeutics (TCT) Russia, Moscow, Russia, June 16, 2014.

L266) “The RAASi Debate: Should RAAS Continue with a Declining GFR?: Will the Path be Clearer” Co-Chair, European Society of Cardiology, Barcelona, Spain, August 31, 2014.

L267) “Novel Markers of Acute and Chronic Kidney Injury,” Where Inflammation Meets

Lipids: Broad Based Strategies for Risk Reduction, Cleveland Heart Labs, Cleveland, OH, September 12, 2014.

L268) “Advances in the Understanding of Acute and Chronic Cardiorenal Syndromes:

Pathophysiological Crosstalk of Multiple Metabolic and Neurohormonal Systems” 41st Williamsburg Cardiovascular Conference, Williamsburg, VA, December 7, 2014.

L269) “CHADS, CHADS-VASc, HAS-BLED, What Does it Mean and How Do We Use It? Atrial

Fibrillation Session, Dallas-Leipzig Valve 2104, Dallas, TX, December 11, 2014.

L270) “Soup-to-Nuts Renal Failure: Caring for the Patient with Kidney Injury” Society of Critical Care Medicine, Phoenix, AZ, January 19, 2015.

L271) “RAASi Optimization in Heart Failure” 2nd Annual Cardiorenal Society of America

Meeting, Phoenix, AS, February 28, 2015.

L272) “Cardiac Surgery Associated Acute Kidney Injury” Association of Physician Assistants in Cardiac Surgery, Las Vegas, NV, March 3, 2015.

L273) “The Potassium Challenge in CKD: Managing Acute and Chronic Hyperkalemia: Novel

Polymer-Based Potassium Binders: Clinical Evidence” NKF Spring Clinical Meetings, March 27, 2015.

L274) “KEEP Healthy: Insights into CKD Care” NKF Spring Clinical Meetings, March 28, 2015.

L275) “The Heart of the Matter” NKF Spring Clinical Meetings, March 28, 2015.

L276) “Literature Review: CVD” NKF Spring Clinical Meetings, March 28, 2015.

L277) “Biomarkers of Kidney and Heart Injury in Cardiorenal Syndrome” Cardionephrology

2015, Rome, Italy, April 16, 2015.

L278) “AKI after Acute Myocardial Infarction: Contrast, Organ Crosstalk and Complications” 33rd Vicenza Course on Critical Care Nephrology in Vicenza, Italy, June 9-12, 2015.

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L279) “A New Mechanism of Action for Addressing Hyperkalemia: New Data on Non-Polymer Hyperkalemia Therapies” 33rd Vicenza Course on Critical Care Nephrology in Vicenza, Italy, June 9-12, 2015.

L280) “Lp-PLA2 as a marker of Vascular Inflammation and CHD Risk Assessment”

Symposium: Advances in Laboratory Testing for Coronary Heart Disease; The New PLAC Test for Lp-PLA2 Activity, American Association of Clinical Chemistry Annual Meeting, Atlanta, GA, June 29, 2015.

L281) “Galectin-3 in the Prognosis and Management of Heart Failure” American

Association of Clinical Chemistry Annual Meeting, Atlanta, GA, June 29, 2015.

L282) “Cardio-Renal Syndrome and Clinical Implications” AKI from Pathophysiology to Clinical Implications, Global Research on Acute Conditions Team (GREAT) Annual Meeting, Rome, Italy, September 5, 2015.

L283) “Lp-PLA2 and Testing for Primary Prevention Risk Assessment” 2015 Cardiometabolic

Health Congress, Harvard Medical School, Boston, MA, October 22, 2015.

L284) “Heart and Kidney: a Dangerous Liaison” Comorbidities in Heart Failure: From Guidelines to Clinical Practice, 775 Anniversary University of Sienna, Sienna, Italy, October 29, 2015.

L285) “Role of BNP, Pro-BNP, and Elevated Left Ventricular Mass in Cardiorenal Syndrome”

American Society of Nephrology Kidney Week, San Diego, CA, November 6, 2015.

L286) “How to Use Urine Thromboxane B2 to Select and Monitor Aspirin Therapy” Moderator, Scientific Sessions 2015, AHA, Orlando, FL, November 10, 2015.

L287) “Putting it All Together: How to Use Urine 11-Dehydrothromboxane B2

In Clinical Practice” Scientific Sessions 2015, AHA, Orlando, FL, November 10, 2015.

L288) “Neurogenic Orthostatic Hypotension” Moderator, Scientific Sessions 2015, AHA, Orlando, FL, November 10, 2015.

L289) “Cardiac Cachexia” Managing Disease Related Lean Body Mass Loss Through Clinical

and Nutritional Interventions, The Sackler Institute for Nutrition Science The New York Academy of Sciences, New York, NY, December 4, 2015.

L290) “The Devastating Consequences of Systemic Hypertension and What To Do About

It?” 42st Williamsburg Cardiovascular Conference, Williamsburg, VA, December 6-8, 2015.

L291) “The Impact and Management of Malnutrition in Patients with Heart Failure” Heart Failure University 2015, Conference Co-Chair, Los Angeles, CA, December 11-13, 2015.

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L292) “Acute and Chronic Cardiovascular Effects of Hyperkalemia: New Insights Into

Prevention and Clinical Management” Heart Failure University 2015, Conference Co-Chair, Los Angeles, CA, December 11-13, 2015.

L293) “Lipoic Acid in the Prevention of Acute Kidney Injury” 21st International Conference

on Continuous Renal Replacement Therapies CRRT 2016, San Diego, CA, February 16-18, 2016.

L294) “Novel Approaches for Recognition and Management of Life Threatening

Complications of AKI and CKD” 21st International Conference on Continuous Renal Replacement Therapies CRRT 2016, San Diego, CA, February 16-18, 2016.

L295) “Making Iodinated Contrast Less Nephrotoxic with Cyclodextrin” 21st International

Conference on Continuous Renal Replacement Therapies CRRT 2016, San Diego, CA, February 16-18, 2016.

L296) “Cardiorenal Syndrome” 4th Annual Cardio-Renal Metabolic Conference, Cardiorenal

Society of America, Phoenix, AZ, March 13, 2016.

L297) “Cardiorenal Syndromes Identification: Prevention and Management of CI-AKI” China Interventional Therapeutics (CIT), Beijing, Shanghai Zhong Shan Hospital, Shanghai, The 2nd Affiliated Hospital of Zhejiang University, Hangzhou, Xi Jing Hospital, Xi’an, Nanjing 1st Hospital, Nanjing, Peoples Republic of China, March 14-21, 2016.

L298) “Cardiorenal Syndromes” Keynote Address, Inaugural Cardio-Renal Connections

Meeting, San Antonio, TX , April 16, 2016.

L299) “Galectin-3 in the Prognosis and Management of Heart Failure” American Association of Clinical Chemistry Annual Scientific Meeting, Philadelphia, PA, August 1, 2016.

L300) Hemodialysis University, “Is It Heart Failure or Fluid Overload?”, Chicago, IL,

September 10, 2016.

L301) “Novel Agents for the Treatment of Hyperkalemia” Heart Failure Society of America Annual Scientific Meeting, Orlando, FL, September 18, 2016.

L302) Symposium “Hyperkalemia in the Emergency Department: Updates on the Current

Management of a Complex Condition.” “Novel Agents for the Prevention and Treatment of Hyperkalemia” American College of Emergency Physicians Scientific Assembly, Las Vegas, NV, October 14, 2016

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L303) Moderator “CVD in Patients with CKD: Update from the CRIC Study” Annual Scientific Sessions of the AHA, New Orleans, LA, November 13, 2016

L304) Program Chairman “A Night at the Museum: Inaugural Symposium of the

Cardiorenal Society of America Transcending the Dinosaurs: Guiding AKI Prevention using next-gen biomarkers: Real World Experiences from modern practices” satellite Symposium at American Society of Nephrology Kidney Week, Field Museum, Chicago, IL, November 18, 2016

L305) “Pathobiologic Systems Involved in Cardiorenal Disease” 43rd Williamsburg

Cardiovascular Conference, Williamsburg, VA, December 3-5, 2016

L306) “Cardiac Cachexia” Heart Failure University, MedReviews LLC, Los Angeles, CA, December 10, 2016

L307) “Is There a Role for Bariatric Surgery in Heart Failure Patients with Obesity?”

Scientific Sessions 2017, American College of Cardiology , Washington, DC, March 18, 2017

L308) “Vascular and Cardiac Hypertrophy in Fabry Disease” 5th Annual Fabry Nephropathy Update, Mexico City, Mexico, April 26, 2017

L309) “Introduction to Cardiorenal Medicine” Cardiorenal University, Anaheim, CA, May

18, 2017

L310) “Sudden Death in End-Stage Renal Disease” Cardiorenal University, Anaheim, CA, May 18, 2017

L311) “Cardiorenal Syndromes and Heart Failure” Conference Chair, Disease Global

Outcomes (KDIGO) Controversies Conference on Heart Failure in Chronic Kidney Disease, Athens, Greece, May 25-28, 2017

L312) “Vadadustat Does Not Prolong Corrected QT Interval In A Thorough QTC Study In

Healthy Subjects” 54th ERA-EDTA Congress, Madrid, Spain, June 3-6, 2017

L313) “Cardiorenal Syndromes” 1st Annual Heart iN Diabetes: Where the Heart, Kidney, and Diabetes Meet in Clinical Practice, Philadelphia, PA, July 14-16, 2017

L314) “Cardiovascular Disease in Patients with Chronic Kidney Disease: A Serious Link” TOP

2017--Target Organ Protection Conference, Bangalore, India, August 11, 2017

L315) “Statin Therapy to Prevent Onset and Progression of Vascular Disease” TOP 2017--Target Organ Protection Conference, Bangalore, India, August 11, 2017

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L316) “Keynote Address: Cardiorenal Society of America” 5th Annual Scientific Meeting of the Cardiorenal Society of America, Phoenix, AZ, October 6, 2017

L317) “Cardiovascular Benefits of Home Hemodialysis” Addressing Unmet Needs in Dialysis:

Cardiovascular Care and Volume Control Symposium, Kidney Week 2017 American Society of Nephrology, New Orleans, LA, November 4, 2017

L318) “CIEDs in ESRD Patients: What Are the Long-Term Data?” Kidney Week 2017

American Society of Nephrology, New Orleans, LA, November 4, 2017

L319) “Cardiovascular Seminar Cardiorenal Syndrome: Who hurts who?” AHA Scientific Sessions 2017, Anaheim, CA, November 14, 2017

L320) “Cardiac and Renal Fibrosis in CRS” AHA Scientific Sessions 2017, Anaheim, CA,

November 14, 2017

L321) Chair, Inaugural Cardiometabolic University and Nutrition Academy “The Skinny on Weight Loss: Practical Considerations for the Cardiovascular Specialist” MedReviews, Westlake, TX, December 1-3, 2017

L322) “Clinical Laboratory Advancements in Cardiometabolic Disease: Screening, Diagnosis,

Prognosis, and Management” 44th Annual Williamsburg Conference on Heart Disease, Williamsburg, VA, December 4, 2017

L323) “The Skinny on Weight Loss: Practical Approaches for the Cardiovascular Specialist”

Cardiometabolic University 2017, Conference Chair, Dallas, TX , December 1-3, 2017

L324) “Diagnosis, Evaluation, and Role of Biomarkers in Heart Failure” Heart Failure University 2017, Conference Co-Chair, Los Angeles, CA, December 10-12, 2017

L325) “Biomarkers of Kidney Dysfunction and Cardiorenal Syndrome” University of

California at San Diego 14th Annual Biomarkers in Heart Failure and Acute Coronary Syndromes: Diagnosis, Treatment and Devices, San Diego, CA, March 2, 2018

L326) “What do I do to Prevent Contrast Induced Renal Injury” 23rd International

Conference on Continuous Renal Replacement Therapies CRRT 2018, San Diego, CA, March 8, 2018

L327) “AKI in the patient with Cancer” 23rd International Conference on Continuous Renal

Replacement Therapies CRRT 2018, San Diego, CA, March 8, 2018.

L328) “CKD-Related Anemia and Cardiac Complications” NKF Spring Clinical Meetings, Austin, TX April 14, 2018

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L329) “Principles of Distributive Shock” Cardiorenal Society of America National Grand Rounds Series, Boston, MA, April 30, 2018

L330) “Biomarkers with More Muscle: Moving Beyond Serum Creatinine to Define

Cardiorenal Syndrome in HF” Heart Failure Society of American Annual Scientific Sessions, Nashville, TN, September 15, 2018

L331) “Heart Failure in Cardiorenal Syndrome: Updates on Biomarkers” Cardiorenal Society

of America Annual Scientific Meeting, Phoenix, AZ, October 6, 2018

L332) “Novel Approaches in Lowering LDL-C” Cardiorenal Society of America Annual Scientific Meeting, Phoenix, AZ, October 6, 2018

L333) “What Do We Know About Cardiorenal Physiology? An Overview” American Society

of Nephrology Kidney Week, San Diego, CA, October 26, 2018

L334) “Prevention of Heart Failure: The Next Frontier” Cardiometabolic Health Conference, Boston, MA, October 27, 2018

L335) “AKI and Heart Failure: How to Manage Compared to the General Population”

Cardiometabolic Health Conference, Boston, MA, October 27, 2018

L336) “SGLT-2 Inhibitors and Cardio-renal Outcomes: Mechanistic Role and Rationale for Treatment of Heart Failure” American Heart Association Annual Scientific Sessions, Chicago, IL, November 10, 2018

L337) “Obesity and Heart Disease” 44th Annual Williamsburg Conference on Heart Disease,

Williamsburg, VA, December 4, 2018

L338) “Current Concepts in Hypertension Management” University of Texas Health Science Center, Tyler, TX, January 15, 2019

L339) “Managing the Heart Failure Patient with Worsening Renal Function (WRF)” 24th

International Conference on Continuous Renal Replacement Therapies CRRT 2019, San Diego, CA, February 28, 2019

L340) “Cardiorenal Syndrome: What Have We Learned?” 24th International Conference on

Continuous Renal Replacement Therapies CRRT 2019, San Diego, CA, February 28, 2019

L341) ” Debate: Biomarker Guided Heart Failure Therapy: Con: Neuropeptides; ST2” 15th Annual USCD Biomarkers in Heart Failure and Acute Coronary Syndromes, Diagnosis, Treatment & Devices, La Jolla, CA March 1, 2019

L342) “Cardiorenal Syndromes” Cardionephrology Congress, Rome, March 12 to 14, 2019

App000329


L343) “Iron and Heart Failure” Cardiometabolic Health Congress West meeting in Phoenix,

AZ on Saturday, May 4, 2019

L344) “Up to Date Management of Arrhythmias in Dialysis Patients” National Kidney Foundation Spring Clinical Meetings, May 11, 2019

L345) “Lipids in Chronic Kidney Disease” National Kidney Foundation Spring Clinical

Meetings, May 11, 2019

L346) “Cardiorenal Syndromes” Helen Dunham Cardio-Renal Lecture and Cardiovascular Grand Rounds, Brigham and Women’s Hospital, Boston, MA, May 23, 2019

L347) “Chronic Kidney Disease as a Cardiovascular Risk State” Helen Dunham Cardio-Renal Lecture and Cardiovascular Grand Rounds, Brigham and Women’s Hospital, Boston, MA, May 23, 2019

L348) “Biomarkers and Assessment of Cardiac Function In Fabry Cardiomyopathy” 6th

Update on Fabry Disease: Biomarkers, Progression and Treatment Opportunities, Prague, Czech Republic, May 26-28, 2019

L349) “Contrast-Induced Acute Kidney Injury” 37th Vicenza Course on AKI &CRRT, Vicenza,

Italy, May, 28-30 2019

L350) “Cardiac Biomarkers in AKI” 37th Vicenza Course on AKI &CRRT, Vicenza, Italy, May, 28-30 2019

L351) “Risk Mitigation in the Cardiac Catheterization Laboratory” 37th Vicenza Course on

AKI &CRRT, Vicenza, Italy, May, 28-30 2019

L352) “Pathophysiology and Current Concepts in Classification” Clinical Practice Clinical Science Track: Treatment of Cardiorenal Syndrome, American Heart Association Hypertension Scientific Sessions, New Orleans, LA, Sept 8, 2019

L353) “Cardiovascular Genetics” 44th Annual Williamsburg Conference on Heart Disease,

Williamsburg, VA, December 9, 2019

L354) “Cardiorenal Syndromes” 17th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC), Los Angeles, CA, December 4-7, 2019

L355) “Cardiorenal Syndromes” Internal Medicine Grand Rounds, Eastern Virginia College

of Medicine, Norfolk, VA, February 19, 2020

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L356) "Keynote Address: Prevention of Heart and Kidney Disease” Annual Cardio Renal Metabolic Conference, Cardiorenal Society of America, Phoenix, AZ March 6, 2020

L357) “Cardioprotective Effects of Antidiabetic Medications: Focus on Sodium-Glucose

Transporter-2 Antagonists” Annual Cardio Renal Metabolic Conference, Cardiorenal Society of America, Phoenix, AZ March 7, 2020

L358) “Fabry Disease: A Unique Cardiorenal Model” Annual Cardio Renal Metabolic

Conference, Cardiorenal Society of America, Phoenix, AZ March 7, 2020

L359) “Biomarkers in Heart and Kidney Disease: Practical Applications” Annual Cardio Renal Metabolic Conference, Cardiorenal Society of America, Phoenix, AZ March 7, 2020

L360) “Expert Briefing from ADA 2020 Select Sessions: Update on Heart Failure for the

Diabetologist & Cardiorenal–Metabolic Axis in Diabetes” American Diabetes Association, June 14, 2020

L361) “CKD, CHD and Hyperkalaemia: Clinical Outcomes, Morbidity and Mortality”

American College of Cardiology - American Society of Nephrology Masterclass September 11, 2020

L362) “RAASi Enabling in Cardiology Practice - Traditional vs New Potassium Binders;

Potassium Binders for Treatment of Hyperkalaemia in HF” American College of Cardiology -American Society of Nephrology Masterclass September 11, 2020

L363) ”Optimizing Transitions from Hospital to Home: Best Practices for Reducing

Readmissions in Heart Failure” Hospital Management Summit, October 3, 2020.

L364) “Assessment and Management of Hyperkalemia in the Hospital Setting: Optimizing Patient Outcomes” Hospital Management Summit, October 3, 2020.

L365) “Navigating the Challenges of Cardio-Renal Syndrome” 7th Annual Kansas

Cardiovascular Symposium, October 10, 2020

L366) ”Management Considerations for Heart Failure in CKD” American Society of Nephrology Kidney Week 2020, October 24, 2020

L367) “Pathophysiologic Basis and Rationale for Early Ambulatory Treatment of SARS-CoV-2

(COVID-19), SciInov, November 2, 2020

L368) “CV and Renal Benefits with new anti-diabetes medications: Potential Mechanisms” CReDO Conferences Middle East North Africa (MENA) 2020, November 6, 2020

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L369) “Consequences of Withholding GDMT for Heart Failure in CKD: One Step Forward, Two Steps Back” AHA 2020 November 16, 2020

L370) “Early Ambulatory Treatment for SARS-CoV-2 (COVID-19)” Early Outpatient

Treatment: An Essential Part of a COVID-19 Solution. US. Senate Committee on Homeland Security and Governmental Affairs, Washington DC November 19, 2020

L371) “Pathophysiological Basis & Rationale for Early Outpatient Treatment of SARS-CoV-2

(COVID-19) Infection” 18th Annual World Congress Insulin Resistance Diabetes & Cardiovascular Disease, December 3, 2020

L372) “Early Ambulatory Therapy for COVID-19 and Update on Vaccine Safety” Heritage

Foundation, Washington DC, June 23, 2021

L373) “Pathophysiological Basis and Clinical Rationale for Early Ambulatory Treatment of COVID-19” Question Everything Conference Lockdowns – Is Now the Time for a Better Solution?, London, UK, July 17, 2021

L374) “Pathophysiological Basis and Clinical Rationale for Early Ambulatory Treatment of

COVID-19 and Update on Vaccine Safety” American Academy of Anti-Aging Medicine, Ann Arbor, MI, July 18, 2021

L375) “Keynote: Winning the War Against Therapeutic Nihilism and the Rush to Replace

Trusted Treatments with Untested Novel Therapies” Association of American Physicians and Surgeons, AAPS 78th Annual Meeting, Sept. 30 to Oct. 2, 2021 – Pittsburgh, PA, October 2, 2021

INTERNAL COMMITTEE POSITIONS

1) Member, Henry Ford Medical Group Hypertension Control Committee, 1998.

2) Ranking Member and Presenter, HFHS Institutional Review Board, 1998-2000.

3) Member, HFHS Teaching and Education Committee, Co-Chair of the Research Subcommittee, 1999-2000

4) Member, HFHS Graduate Medical Education Committee, 1999-2000.

5) Member, HFHS, Internal Medicine Residency Selection Committee, 1998-2000.

6) Chair, HFHS, Cardiovascular Diseases Fellowship Program Selection Committee, 1999-2000.

App000332


7) Co-Chair, HFHS, Information Technology and Medical Records Committee, 1999-2000.

8) Member, HFHS Department of Internal Medicine, Research Committee, 1999-2000.

9) Member, UMKC Adult Health Sciences Institutional Review Board, 2001-2002

10) Member, UMKC, Cardiovascular Diseases Fellowship Program Selection Committee, 2000-2002

11) Member, Truman Medical Center (TMC) Information Technology Steering Committee, 2001-

2002.

12) Member, WBH Diabetes Research Center Steering Committee, 2002-2003

13) Chairperson, WBH Staff Privileges Appeals Committee, March 31, 2004

14) Chairperson, WBH Search Committee for Medical Director of Transplantation Medicine, 2005-2006

15) WBH Research Institute Board of Governors, board member, 2007-2010 16) Oakland University William Beaumont School of Medicine, Medical Student Committee

(founding) for development of Liaison Committee on Medical Education (LCME) application, 2007-2010

17) St. John Providence Health System Graduate Medical Education Steering Committee (Chair),

2010 to 2013

18) St. John Providence Health System Research Leaders Committee, Chair, 2010 to 2012; Co-Chair 2012 to 2013

19) Ascension Michigan Research Affinity Group, Chair, 2010 to 2012; Co-Chair 2012 to 2013

20) St. John Providence Health System Executive Committee, 2011 to 2013 21) St. John Providence Health System Guidelines Committee, 2012 to 2013 22) St. John Providence Health System Presidents Council, 2012 to 2013

23) St. John Providence Health System Electronic Medical Record Meaningful Use Steering

Committee, 2013

24) BUMC Graduate Medical Education Committee, 2014 to present

App000333


25) BUMC Internal Medicine Residency Program Clinical Competency Committee, 2014 to 2021

26) BUMC Clinical Cardiology Fellowship Program Clinical Competency Committee, 2014 to 2021

27) BUMC Founding Member, Department of Molecular Pathology and Medicine, 2016 to 2021

28) BUMC Precision Medicine Executive Committee, 2016 to 2021

29) BUMC COVID-19 Therapeutic Task Force 2020

EXTERNAL COMMITTEE POSITIONS

1) Member, AHA National Women’s Heart Disease and Stroke Campaign, Healthcare Provider Sub-Group, Dallas, TX, 1998-1999

2) Member, AHA, Chronic Coronary Disease in the Elderly National Database Planning

Committee, Dallas, TX, 1998-2000

3) Chair, Michigan Chapter of the American College of Cardiology, Annual Mini-Board Review, 1999-2000

4) Member, Michigan Chapter of the American College of Cardiology, Annual Meeting Planning

Committee, 1999-2000

5) Member, National Kidney Disease Outcomes Quality Initiative (K/DOQI) Clinical Practice Guidelines Committee on Chronic Kidney Disease, Andrew S. Levey, MD, Chair, 2001-2002

6) Member, K/DOQI Learning System (KLS) Advisory Board, NKF, New York, NY, 2003 to

2010

7) Member, International EECP Patient Registry Working Group, 2003-2008. 8) Counselor at large, Michigan Chapter of the American College of Cardiology, 2004-2006

9) Member, Planning Committee, AHA, Prevention VIII Conference: Kidney Disease,

Hypertension, and Cardiovascular Disease, January 26-28, 2006, Orlando, FL

10) Chair, Contrast-Induced Nephropathy (CIN) Working Group Consensus Panel, (international, multispecialty, consensus panel with published findings) 2004-2006. Published in Am J Cardiol 2006 Vol 98(6)

App000334


11) Workgroup Member, Kidney Disease Improving Global Outcomes (KDIGO), United States Representative, Amsterdam, Netherlands, 2004, 2006

12) Member, Kidney Disease Improving Global Outcomes (KDIGO) Group for the development

of Clinical Practice Guidelines for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease Related Mineral and Bone Disorders (CKD-MBD), Paris, France, 2007-2008

13) Board of Directors Member, Kidney Disease Improving Global Outcomes (KDIGO), United

States Representative, Brussels, Belgium, 2007-2010 14) Workgroup Member, The Sixth International Acute Dialysis Quality Initiative (ADQI)

Consensus Conference VI: Acute Kidney Injury in Cardiac Surgery, Vicenza, Italy May 27 – 28, 2007

15) Workgroup Leader, Prevention: The Seventh International Acute Dialysis Quality Initiative

(ADQI) Consensus Conference VII: Cardiorenal Syndrome, Venice, Italy, September 4-5, 2008, with publication n Nephrology, Dialysis, and Transplantation, 2010.

16) Chairman, Natriuretic Peptide Testing in Acute Coronary Syndromes Consensus Panel, with

published findings in Reviews in Cardiovascular Medicine 2010, Dallas, TX, March 2, 2010

17) Scientific Advisory Board, NKF, New York, NY, 2010 to present

18) Scientific Advisory Board, Cardiorenal Society of America, Phoenix, AZ, 2012 to present

19) Workgroup Member, “Cardiovascular Disease in CKD: What is it and what can we do about it?” Kidney Disease Improving Global Outcomes (KDIGO), October 29-31, 2010, London, England.

20) Chairman, “Cardio-Renal Syndromes II: from pathophysiology to therapy” Eleventh

Consensus Conference Cardio-Renal Syndromes II November 30 – December 2, 2012, Venice, Italy.

21) Conference Co-Chair: “Kidney Disease Global Outcomes (KDIGO) Controversies Conference

on Heart Failure in Chronic Kidney Disease”, Athens, Greece, May 25-28, 2017

22) Chairman, “Cardiometabolic University”, Dallas, TX, December 3-4, 2017

23) Chair, American Heart Association Council on the Kidney in Cardiovascular Disease and Council on Clinical Cardiology. Cardiorenal Syndrome: Classification, Pathophysiology, Diagnosis, and Treatment Strategies: A Scientific Statement From the American Heart Association, 2019

App000335


24) Committee Member, American College of Cardiology, Navigating Treatment Decisions for Patients with ASCVD and Multiple Comorbidities Committee, 2019-2020

25) Chief Medical Advisor, Truth for Health Foundation, Tucson AZ, 2021 to present

26) Advisory Board Member, TrialSite News, 2021 to present

27) National and International Advisor/Reviewer/Presenter/Contributor for 4D Molecular

Therapies, ABC News, Abbott Laboratories, AbbVie, Advanced Health Media, Aegerion, Affymax, Akceia, Akebia, Alere North America, AMAG, Amersham, Amgen, Amylin, AntiSeptiscope, Aralez, Ardian, Adelyx, Arra Hitech, Astellas, AstraZeneca, Astute Medical, Atherotech, Axio, BG Medicine, Avenue Therapeutics, Aventyn, Back Bay Lifescience Advisors, Bayer, Biocritique, Bioexpertise, Biomarin, Bionest Partners, Bioporto, Biosite, Biostar, BioZ, Boehringer Ingelheim, Braintree Laboratories, Broeker, Bristol Myer Squibb, Cardiokine, Cardiorentis, Chapman and Priest, Charles River Associates, Chelsea Therapeutics, Chiesi USA, ClearView Healthcare Partners, Clinipace, Complexa, Connected Research and Consulting, CorMedix, Cornerstone Therapeutics, Corvidia, Covance, Critical Diagnostics, Cromsource, Crossover Technologies, Chrysalis BioTherapeutics, Cytopheryx, Cytel, DaVita, Daws, DeMatteo Monness, Diadexus, Daiichi Sankyo, Decision Resources, ECG Healthcare, Edwards Life Sciences, Elsevier, Espirion, F. Hoffmann-La Roche Ltd, Fast Biomedical, Fish and Richardson, LLC, Fisher Scientific, FlowMedica Inc, Frictionless Digital, Fresenius Medical Care, General Electric, Genzyme, Gerson Lehrman, Gilead, GVI Clinical Development Solutions, Health Law Partners, Healthspan DX, HealthSTAR Communications, Hershey, Hikari, Hogan Lovells, Hudson Global, ICON, Huff, Powell, and Bailey, LLC, IMC Press, Imidex, Impact Education, Instrumentation Laboratories, Intercept Pharmaceuticals, Intrinsic Life Sciences, Ischemix Technologies, Janssen, Jannsen, Johnson and Johnson, Jordan, KAI Research, Keryx, Ketchum, Inc, Knowledge Point 360, Kowa, Eli Lilly, LabCorp, Lewis Brisbois, Liberty Dialysis, Ligand, Lipocine, Litchfield Cavo, Luitpold Pharmaceuticals, Lundbeck, Maxaccess Managed Markets, MannKind, MEDACorp, MedEd Group, Medevera, Medical Exchange International, Medical Package, Medicines Company, Medicure Pharma, Inc., MedReviews, Medscape, Medtronic, Merck, Meridian 361 International Law Group, Meso Scale Diagnostics, Miller Tanner Associates, Mitsubishi, Nanomix, Nanosphere, Nabi Biopharmaceuticals, Navigant, NephroGenix, Neumedicines, Noorik GmbH, Norman, Hanson, and Detroy, LLC, Novartis, NovoNordisk, NxStage, Ortho Clinical Diagnostics, Osprey, Otsuka, Overcome, P-value Communications, Parexel, Pharmapprove, Pfizer, Phoenix Holdings, Physicians World, PLC Medical, Praetego, PriMed, Progenabiome, Quidel Corporation, Qualidigm, Quintiles, Reata, Reliant Pharmaceuticals, Renew Research, Relypsa, Repros Therapeutics, Roche Diagnostics, Rock Creek, Saferox, Saghmos Therapeutics, Salix, Sanfit, Sankyo, Sanofi, Sarepta Therapeutics, Scarritt Group, Sentinel Investment, Sloan Law Firm, Sphingotec, Spectracell, St. Jude Medical, Strataca Systems, Statprobe, Sunshine Heart, Synageva, Takeda, Tasly, TheHill, Thrasos, TrialSiteNews, Trinity, Triptych Health Partners, US Medical Management, Vasomedical, Verrow, Vindico, Visiting Physicians Association, Vitalmetrix, Vivus, Watermark, WebMD, ZS Pharma, Inc.

App000336


Exhibit

App000337


1

UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF TEXAS

PUBLIC HEALTH AND MEDICAL PROFESSIONALS FOR TRANSPARENCY, Plaintiff, -against- FOOD AND DRUG ADMINISTRATION, Defendant.

Civil Action No. 4:21-cv-01058-P

DECLARATION OF AARON SIRI, ESQ.

I, Aaron Siri, declare as follows:

1. I am the Managing Partner of Siri & Glimstad LLP, counsel to Public Health and

Medical Professionals for Transparency (“PHMPT”). I am admitted to practice pro hac vice in

this action. I make this declaration in support of PHMPT’s motion for expedited production.

2. The following is a link to a true and correct copy of a video of candidate Joe Biden

stating, “[y]ou’ve got to make all of it [the vaccine data] available to other experts across the nation

so they can look and see, so there’s a consensus this is a safe vaccine” available at https://www.c-

span.org/video/?c4988427/user-clip-jul-28-2020.

3. The following is a link to a true and correct copy of a video of Joe Biden stating, “I

get asked the question, if . . . President [Trump] announced tomorrow we have a vaccine, would

you take it? Only if it was completely transparent and other experts in the country could look at

it. Only if we knew all of what went into it” available at https://www.facebook.com/ABCNews

Politics/videos/902987476894155/ (at 24:10).

App000338


2

4. The following is a link to a true and correct copy of a video of Joe Biden stating

that we need “total transparency so scientists outside the government know exactly what Is being

approved” available at https://abcnews.go.com/Politics/video/biden-trust-vaccine-proven-safe-

scientists-73058501.

5. Exhibit 1, attached hereto, is a true and correct copy of a document on the FDA’s

website titled “Detail of Full-Time Equivalents” available at https://www.fda.gov/media/132

813/download.

6. Exhibit 2, attached hereto, is a true and correct copy of a page on the White House

website titled “Remarks by President Biden at Virtual Global COVID-19 Summit” available at

https://www.whitehouse.gov/briefing-room/speeches-remarks/2021/09/22/remarks-by-president-

biden-at-virtual-global-covid-19-summit/.

7. Exhibit 3, attached hereto, is a true and correct copy of an article titled “Wait what?

FDA wants 55 years to process FOIA request over vaccine data” available at https://www.reuters.

com/legal/government/wait-what-fda-wants-55-years-process-foia-request-over-vaccine-data-

2021-11-18/.

8. Exhibit 4, attached hereto, is a true and correct copy of a letter from members of

the United States Senate to The Honorable Dr. Stephen Hahn dated September 14, 2020, available

at https://www.warren.senate.gov/imo/media/doc/2020.09.14%20Letter%20to%20FDA%20re%

20transparency%20in%20vaccine%20review%20process_.pdf.

9. Exhibit 5, attached hereto, is a true and correct copy of a press release titled “Rep.

Ralph Norman Introduces Legislation to Expedite FDA Compliance with FOIA Requests for

Vaccine Approval Data” available at https://norman.house.gov/news/documentsingle.aspx?Docu

mentID=1087.

App000339


3

10. Exhibit 6, attached hereto, is a true and correct screenshot of a tweet by Senator

Ted Cruz, available at https://twitter.com/tedcruz/status/1461523687333666817.

11. Exhibit 7, attached hereto, is a true and correct copy of a press release titled “Pfizer

and BioNTech Announce an Agreement with U.S. Government for Up To 600 Million Doses of

mRNA-Based vaccine Candidate Against SARS-CoV-2” available at https://www.pfizer.com/

news/press-release/press-release-detail/pfizer-and-biontech-announce-agreement-us-government-

600.

12. Exhibit 8, attached hereto, is a true and correct copy of a press release titled “Biden

Administration purchases additional doses of COVID-19 vaccines from Pfizer and Moderna”

available at https://www.hhs.gov/about/news/2021/02/11/biden-administration-purchases-addit

ional-doses-covid-19-vaccines-from-pfizer-and-moderna.html.

13. Exhibit 9, attached hereto, is a true and correct copy of an article that appears on

the Pharmacy Today website titled “U.S. buys 200 million COVID-19 vaccines from Pfizer and

BioNTech at about $24 a dose” available at https://www.pharmacytoday.org/drugs/drugs-2021-

07-27-story2.

14. Exhibit 10, attached hereto, is a true and correct copy of a page on the U.S.

Department of Defense’s website titled “Contracts For Aug. 2, 2021” available at https://www.def

ense.gov/News/Contracts/Contract/Article/2716710/.

15. Exhibit 11, attached hereto, is a true and correct copy of an article titled "U.S.

Purchases Additional 50 Million Pediatric Doses Of Covid-19 Vaccine, Pfizer Says" available at

https://www.forbes.com/sites/roberthart/2021/10/28/us-purchases-additional-50-million-pediatric

-doses-of-covid-19-vaccine-pfizer-says/?sh=292ea8c72e62.

App000340


4

16. Exhibit 12, attached hereto, is a true and correct copy of a page on the U.S.

Department of Defense’s website titled “Contracts For Nov. 22, 2021” available at https://www.de

fense.gov/News/Contracts/Contract/Article/2851450/.

17. Exhibit 13, attached hereto, is a true and correct copy of a page on the Centers for

Disease Control and Prevention’s website titled “Novel Coronavirus (COVID-19)” available at

https://www.cdc.gov/budget/fact-sheets/covid-19/index.html.

18. Exhibit 14, attached hereto, is a true and correct copy of a page on The White House

website titled "FACT SHEET: Biden Administration Announces Historic $10 Billion Investment

to Expand Access to COVID-19 Vaccines and Build Vaccine Confidence In Hardest-Hit and

Highest-Risk Communities" available at https://www.whitehouse.gov/briefing-room/statements-

releases/2021/03/25/fact-sheet-biden-administration-announces-historic-10-billion-investment-

to-expand-access-to-covid-19-vaccines-and-build-vaccine-confidence-in-hardest-hit-and-highest-

risk-communities/.

19. Exhibit 15, attached hereto, is a true and correct copy of an article titled "White

House announces new funds for COVID-19 testing and vaccination amid delta surge" available at

https://thehill.com/policy/healthcare/564335-white-house-announces-new-funds-for-covid-19-

testing-and-vaccination-amid.

20. Exhibit 16, attached hereto, is a true and correct copy of an email from Courtney

D. Enlow dated December 1, 2021.

21. Exhibit 17, attached hereto, is a true and correct screenshot of data from the Centers

for Disease Control and Prevention’s COVID Data Tracker, available at https://covid.cdc.gov/

covid-data-tracker/#vaccinations_vacc-total-admin-rate-total.

App000341


5

22. Exhibit 18, attached hereto, is a true and correct copy of an article titled “States

with High Vaccination Rates Can Still Experience COVID-19 Surges – Here’s Why” available at

https://www.healthline.com/health-news/states-with-high-vaccination-rates-can-still-experience-

covid-19-surges-heres-why.

23. Exhibit 19, attached hereto, is a true and correct copy of a Media Statement titled

“Statement from CDC Director Rochelle P. Walensky, MD, MPH on Today's MMWR” available

at https://www.cdc.gov/media/releases/2021/s0730-mmwr-covid-19.html.

24. Exhibit 20, attached hereto, is a true and correct copy of an article titled “The new

Omicron COVID variant Is a stark reminder that we are still In the depths of the pandemic”

available at https://fortune.com/2021/11/26/omicron-south-africa-covid-variant-vaccine-resistant-

pandemic/.

25. Exhibit 21, attached hereto, is a true and correct copy of an article titled “Rising

Covid-19 Breakthrough Cases Hinder Efforts to Control Virus” available at

https://www.wsj.com/articles/rising-covid-19-breakthrough-cases-hinder-efforts-to-control-

virus-11636191003.

26. Exhibit 22, attached hereto, is a true and correct copy of a page on the Centers for

Disease Control and Prevention’s website titled “COVID-19 Vaccine Booster Shots” available at

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/booster-shot.html.

27. Exhibit 23, attached hereto, is a true and correct copy of a page on Pfizer's website

titled “Transparency In Clinical Trials” available at https://cdn.pfizer.com/pfizercom/Clinical-

Trial-Transparency-Policy-Paper-FINAL-2019.pdf.

28. Exhibit 24, attached hereto, is a true and correct copy of an article titled

“Transparency of COVID-19 vaccine trials: decisions without data” available at

App000342


6

https://archive.hshsl.umaryland.edu/bitstream/handle/10713/16360/bmjebm-2021-111735.full.

pdf?sequence=1&isAllowed=y.

29. Exhibit 25, attached hereto, is a true and correct copy of an FDA News Release

titled “FDA Approves First COVID-19 Vaccine” dated August 23, 2021, available at

https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine.

30. Exhibit 26, attached hereto, is a true and correct copy of a Citizen Petition dated

June 1, 2021, available at https://www.regulations.gov/document/FDA-2021-P-0521-0001.

31. Exhibit 27, attached hereto, is a true and correct copy of an article titled “Why we

petitioned the FDA to refrain from fully approving any covid-19 vaccine this year” available at

https://blogs.bmj.com/bmj/2021/06/08/why-we-petitioned-the-fda-to-refrain-from-fully-

approving-any-covid-19-vaccine-this-year/.

32. Exhibit 28, attached hereto, is a true and correct copy of an article titled “Did the

FDA understaff its review of the Pfizer/BioNTech vaccine?” available at

https://www.statnews.com/2020/12/17/did-the-fda-understaff-its-review-of-the-pfizer-biontech-

vaccine/.

33. Exhibit 29, attached hereto, is a true and correct copy of an article titled “Does the

FDA think these data justify the first full approval of a covid-19 vaccine?” available at

https://blogs.bmj.com/bmj/2021/08/23/does-the-fda-think-these-data-justify-the-first-full-

approval-of-a-covid-19-vaccine/.

34. Exhibit 30, attached hereto, is a true and correct copy of an article titled “Covid-

19: FDA set to grant full approval to Pfizer vaccine without public discussion of data” available at

https://www.bmj.com/content/374/bmj.n2086.

App000343


7


website titled “Fact Sheet: Biden Administration Announces Details of Two Major Vaccination

Policies” available at https://www.whitehouse.gov/briefing-room/statements-releases/2021/11/04/

fact-sheet-biden-administration-announces-details-of-two-major-vaccination-policies/. The full

version of the Emergency Temporary Standard issued by the Occupational Safety and Health

Administration published in the Federal Register on November 5, 2021 is available at

https://www.federalregister.gov/documents/2021/11/05/2021-23643/covid-19-vaccination-and-

testing-emergency-temporary-standard.


website titled “Path Out of the Pandemic” available at https://www.whitehouse.gov/covidplan/.

37. Exhibit 33, attached hereto, is a true and correct copy of a document titled

“Memorandum for Senior Pentagon Leadership Commanders of the Combatant Commands

Defense Agency and DOD Field Activity Directors” available at https://media.defense.gov/

2021/Oct/04/2002867430/-1/-1/0/MANDATORY-CORONAVIRUS-DISEASE-2019-

VACCINATION-OF-DOD-CIVILIAN-EMPLOYEES-OSD008990-21-RESP-FINAL.PDF.

38. Exhibit 34, attached hereto, is a true and correct copy of a page on the University

of Colorado Boulder’s website titled “COVID-19 Vaccination Requirements and Process”

available at https://www.colorado.edu/covid-19-updates/covid-19-vaccination.

39. Exhibit 35, attached hereto, is a true and correct copy of a page on sf.gov titled

“Vaccine required” available at https://sf.gov/information/vaccine-required.

40. Exhibit 36, attached hereto, is a true and correct copy of an article titled “Dr.

Anthony Fauci: Expect ‘a flood’ of COVID-19 vaccine mandates after full FDA approval”

App000344


8

published August 6, 2021, available at https://www.usatoday.com/story/news/health

/2021/08/06/anthony-fauci-covid-vaccine-mandates-fda-full-approval/5513121001/.

41. Exhibit 37, attached hereto, is a true and correct copy of the FOIA request at issue

in this case, which is dated August 27, 2021 and was submitted by PHMPT to the Food and Drug

Administration.

42. Exhibit 38, attached hereto, is a true and correct copy of the confirmation PHMPT

received upon submitting the FOIA Request.

43. Exhibit 39, attached hereto, is a true and correct copy of a letter dated August 31,

2021 issued by the FDA to PHMPT.

44. Exhibit 40, attached hereto, is a true and correct copy of a letter dated September

9, 2021 issued by the FDA to PHMPT.

45. Exhibit 41, attached hereto, is a true and correct copy of an email from Courtney

D. Enlow dated December 2, 2021.

Pursuant to 28 U.S.C. § 1746, I declare under penalty of perjury under the laws of the

United States of America that the foregoing is true and correct to the best of my knowledge.

Dated: December 7, 2021

Aaron Siri, Esq.

App000345


Exhibit

App000346


App000347


Exhibit

App000348


BRIEFING ROOM

Remarks by President Biden at Virtual GlobalCOVID- 19 Summit

SEPTEMBER 22, 2021 • SPEECHES AND REMARKS

South Court Auditorium Eisenhower Executive Office Building

11:16 A.M. EDT

THE PRESIDENT: Good morning, everyone. And thank you for joining us today.

As I said yesterday at the United Nations, nothing is more urgent than all of us workingtogether to defeat COVID-19. And that — that world is going to be much better prepared forfuture pandemics. We have to do both.

This summit is about supercharging our efforts in three key areas: vaccinating the world bydramatically ramping up vaccine production, donations, delivery, and administrating thevaccine, which is a logistical — it’s a logistical challenge; addressing the oxygen crisis in manyhospitals around the world, making other treatments more accessible, and increasing theavailability of public health tools like masks and tests; and building back better so that ourglobal health security infrastructure is more resilient than it is today.

We’ve all suffered. The United States has lost more than 670,000 of our fellow Americans.Worldwide, the death toll is above 4.5 million people — 4.5 million people. And this is a globaltragedy.

And we — and we’re not going to solve this crisis with half-measures or middle-of-the-roadambitions. We need to go big. And we need to do our part: governments, the private sector,civil society leaders, philanthropists. This is an all-hands-on-deck crisis.

And the good news is, we know how to beat this pandemic: vaccines, public health measures,and collective action.

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During the first eight months of my presidency, we have worked aggressively to get Americansand the world vaccinated. As President of the United States, my first responsibility is toprotect the American people. And I am proud that we have gone from 2 million Americansbeing fully vaccinated when I took office in January 20th to 182 million and counting, today, inAmerica.

But we also know that to beat the pandemic here, we need to beat it everywhere. And I madeand I’m keeping the promise that America will become the arsenal of vaccines as we were thearsenal of democracy during World War Two.

We have already shipped nearly 160 million doses to 100 countries, more than every othercountry has donated combined. America’s donations of a half a billion Pfizer vaccines throughCOVAX that I’ve announced before the G7 Summit in June have already begun to ship.

Today, I’m announcing another historic commitment. The United States is buying another halfbillion doses of Pfizer to donate to low- and middle-income countries around the world.

This is another half a billion doses that will all be shipped by this time next year. And it bringsour total commitment to — of donati- — of donated vaccines to over 1.1 billion vaccines to bedonated.

Put another way, for every one shot we’ve administered to date in America, we have nowcommitted to do three shots to the rest of the world.

I want to thank Pfizer and its CEO and chairman, Albert. Albert has been a good friend and hasbeen helpful. They’ve been and continue to be partners and a leader in this fight.

And the United States is leading the world on vaccination donations. We need — as we’redoing that, we need other high-income countries to deliver on their own ambitious vaccinedonations and pledges.

That’s why, today, we’re launching the EU-U.S. vaccine partnership to work more closelytogether and with our partners on expanding global vaccinations.

And as we do so, we should unite around the world on a few principles: that we commit todonating, not selling — donating, not selling, doses to low- and lower-income countries, andthat the donations come with no political strings attached; and that we support COVAX as themain distributor for sharing WHO-approved vaccines; and that we fight vaccinedisinformation and exercise transparency to build vital public trust in these lifesaving tools.

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It’s also important that we are working toward common goals and targets so that we canmeasure our progress and hold ourselves and each other accountable.

Secretary of State Blinken will be convening foreign ministers later this year to check on ourcollective progress. And I propose that we come together for a second high-level virtualsummit in the first quarter of 2022 to help gauge our progress and keep our efforts fullyaligned.

Another goal is dramatically boosting global and regional vaccine manufacturing capacity,enhancing transparency so that vaccine production and distribution is predictable andcoordinated.

In fact, an important part of the reason the United States is able to make these big, historicdonations is because we’ve worked with U.S. vaccine manufacturers to accelerate themanufacturing rate and production. And now we’re working quickly to scale up vaccinemanufacturing in other countries around the world so they can manufacture as well.

We’re working with partner nations, pharmaceutical companies, and other manufacturers toincrease their own capacity and capability to produce and manufacture safe and highlyeffective vaccines in their own countries. For example, our Quad partnership with India,Japan, and Australia is on track to help produce at least 1 billion vaccine doses in India to boostthe global supply by the end of 2022.

And we’re providing financing and helping strengthen manufacturing in South Africa andproduce more than 500 million doses of J&J in Africa, for Africa next year.

And next, we also know from experience that getting those vaccines into people’s arms may bethe hardest logistical challenge we’ve faced. That’s why we need to significantly step up ourinvestment in helping countries get shots in arms.

Today, the United States is also announcing that we’re providing an additional $370 million tosupport administering these shots and delivery globally. And we will be providing more than$380 million to assist in the Global Vaccine Alliance — GAVI — to further facilitate vaccinedistribution in regions in the greatest — with the greatest need.

And while vaccinating the world is the ultimate solution to COVID-19, we know that we haveto act to save lives now. That’s why the United States are providing nearly $1.4 billion toreduce COVID-19 deaths and mitigate transmission through bulk oxygen support, expandedtesting, and strengthening healthcare systems and more.

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And we’re going to help all of us build back better by supporting the establishment of afinancial mechanism for global health security — to simply state — to prepare for the nextpandemic, because there will be a next time. We all know that. Vice President Harris will bespeaking more on this issue later today.

And finally, I want to acknowledge the leaders from the private sector, philanthropy, and civilsociety who are here today.

Governments can do a lot, but we cannot do everything on our own. We’ve asked ournongovernmental partners to take up the call for new actions that will solve the corechallenges of making vaccines available to everyone, everywhere; solving the oxygenavailability crisis; financing health security; and more. And I’m grateful — I’m grateful for theirleadership.

And let me close by — with what I made clear yesterday at the U.N.: We can do this. This iswithin our capacity. We know what needs to be done. We just have to make the choice to doit.

You know, the leaders on the screen that I see here today, I know they’ve made that choice.And I think they know we can do this.

And I promise you, the United States will continue to lead. We’ll continue to drive historiccommitments in vaccine donations — 1.1 billion and counting — so we can defeat COVID-19together.

And we’ll continue to invest in creating a future of true global health security for all people.That is a big, big goal I ha- — we have — we should have. And we’re going to lead with thepower of our example. And we’re not going to stop.

But the only way to get this done is for everyone, everywhere — is for all of us to step up, whichI’m confident you will.

And now I’d like to turn this over to Ambassador Thomas-Greenfield of the United Nations.And I want to thank everybody on the screen I can see here, without going to each one of you.

11:25 A.M. EDT

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Press ReleasesRep. Ralph Norman Introduces Legislation to Expedite FDACompliance with FOIA Requests for Vaccine Approval Data

Washington, D.C., December 2, 2021

Tags: Health Care , Coronavirus , Vaccine Mandates

On Thursday, Congressman Ralph Norman (R-SC) introduced legislation that would

require the Commissioner of the Food and Drug Administration (FDA) to release all

records of information submitted to the FDA regarding the authorization of emergency

use of, or licensing of all COVID-19 vaccines. The bill requires all records and information

to be released to the public no later than 100 days.

Background

The P zer COVID-19 vaccine was licensed by the FDA on August 23, 2021, 108 days after

P zer began submitting documents for approval by the FDA.

The Public Health and Medical Professionals for Transparency (PHMPT) is a group of

public health and medical professionals, which includes professors and scientists from

universities including Yale, Harvard, UCLA, and Brown.

Through a Freedom of Information Act, PHMPT sought an expedited request "to obtain

the data and information relied upon by the FDA to license the P zer Vaccine" in part

to "con rm the FDA’s conclusion that the P zer Vaccine is safe and effective."

The FDA denied expedited processing of PHMPT's request, prompting that

organization to le a lawsuit against the FDA in September 2021. In total, PHMPT is

App000368


seeking more than 329,000 pages of documents detailing the approval of the P zer

vaccine.

On November 15, 2021, FDA attorneys asked the court to allow the FDA to release just

500 pages per month to the public, resulting in a timeline of roughly 55 years for the

disclosure of all documents. More than 256 million doses of P zer's vaccine have been

administered in the United States since the approval of the vaccine in August 2021 by

the FDA.

The FOIA request and lawsuit are exclusive to the FDA approved P zer vaccine, but

Rep. Norman's legislation would require the public release of all documentation related

to P zer, Moderna, and Johnson & Johnson COVID-19 vaccines.

Rep. Norman issued the following statement on Thursday:

"The FDA's only priority should be the health and safety of consumers. The agency has

compromised its integrity by delaying information that belongs to the public. Since the

Biden administration is hell-bent on forcing these vaccine mandates on us, the public

has every right to know how this vaccine was approved, especially in such a short

amount of time. After all, the FDA managed to consider all 329,000 pages of data and

grant emergency approval of the P zer vaccine within just 108 days. So it’s hard to

rationalize why it now needs 55 years to fully release that information to the public."

App000369


HomeeHome

About RaalphAbout Ralph

Seervingg YouServing You

ReesourceesResources

Evene tsEvents

MeMediaaMedia

Contaca tContact

Our Locations

Washington, DC Of ce

For questions about Rep. Norman's votes in Congress,legislation, or federal policies

569 Cannon HOB Washington, DC 20515Phone: (202) 225-5501 FAX: (202) 225-0464

Rock Hill Of ce

For assistance with departments or agencies of thefederal government

454 South Anderson Rd. Suite 302 B

Rock Hill, SC 29730Phone: (803) 327-1114 FAX: (803) 327-4330

App000370


Exhibit

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App000372


Exhibit

App000373


PFIZER AND BIONTECH ANNOUNCE AN AGREEMENT WITH U.S. GOVERNMENT FOR UP TO 600 MILLION DOSES OF MRNA-BASED VACCINE CANDIDATE AGAINST SARS-COV-2Wednesday, July 22, 2020 - 07:10am

NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- P zer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq:

BNTX) today announced the execution of an agreement with the U.S. Department of Health and

Human Services and the Department of Defense to meet the U.S. government’s Operation Warp

Speed program goal to begin delivering 300 million doses of a vaccine for COVID-19 in 2021. Under

the agreement, the U.S. government will receive 100 million doses of BNT162, the COVID-19 vaccine

candidate jointly developed by P zer and BioNTech, after P zer successfully manufactures and

obtains approval or emergency use authorization from U.S. Food and Drug Administration (FDA).

This press release features multimedia. View the full release here:

https://www.businesswire.com/news/home/20200722005438/en/

(https://www.businesswire.com/news/home/20200722005438/en/)

The U.S. government will pay the companies $1.95 billion upon the receipt of the rst 100 million

doses, following FDA authorization or approval. The U.S. government also can acquire up to an

additional 500 million doses.

Americans will receive the vaccine for free consistent with U.S. government’s commitment for free

access for COVID-19 vaccines.

“We’ve been committed to making the impossible possible by working tirelessly to develop and

produce in record time a safe and e ective vaccine to help bring an end to this global health crisis,”

said Dr. Albert Bourla, P zer Chairman and CEO. “We made the early decision to begin clinical work

and large-scale manufacturing at our own risk to ensure that product would be available

U.S. government placed an initial order of 100 million doses for $1.95 billion and can acquire up to 500 million additional dosesAmericans to receive the vaccine for free consistent with U.S. government’s commitment for free access for COVID-19 vaccinesP zer and BioNTech remain on track to begin an anticipated Phase 2b/3 safety and eHide cacy trial laterthis month, seek regulatory review as early as October 2020, and manufacture globally up to 100 million doses by the end of 2020 and potentially more than 1.3 billion doses by the end of 2021

App000374


immediately if our clinical trials prove successful and an Emergency Use Authorization is granted.

We are honored to be a part of this e ort to provide Americans access to protection from this

deadly virus.”

“Expanding Operation Warp Speed’s diverse portfolio by adding a vaccine from P zer and BioNTech

increases the odds that we will have a safe, e ective vaccine as soon as the end of this year,” said

HHS Secretary Alex Azar. “Depending on success in clinical trials, today’s agreement will enable the

delivery of approximately 100 million doses of this vaccine to the American people.”

The BNT162 program is based on BioNTech’s proprietary mRNA technology and supported by

P zer’s global vaccine development and manufacturing capabilities. The BNT162 vaccine candidates

are undergoing clinical studies and are not currently approved for distribution anywhere in the

world. BioNTech is the market authorization holder worldwide and will hold all trademarks for the

potential product. Both collaborators are committed to developing these novel vaccines with pre-

clinical and clinical data at the forefront of all their decision-making.

“We are pleased to have signed this important agreement with the U.S. government to supply the

initial 100 million doses upon approval as part of our commitment to address the global health

threat. This agreement is one of many steps towards providing global access to a safe and

e cacious vaccines for COVID-19. We are also in advanced discussions with multiple other

government bodies and we hope to announce additional supply agreements soon. Our goal

remains to bring a safe and e ective COVID-19 vaccine to many people around the world, as quickly

as we can,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech.

The P zer/BioNTech vaccine development program is evaluating at least four experimental

vaccines, each of which represents a unique combination of messenger RNA (mRNA) format and

target antigen. On July 1st, P zer and BioNTech announced preliminary data from BNT162b1, the

most advanced of the four mRNA formulations. The early data demonstrates that BNT162b1 is able

to produce neutralizing antibodies in humans at or above the levels observed in the plasma from

patients who have recovered from COVID-19, and this was shown at relatively low dose levels. Local

reactions and systemic events were dose-dependent, generally mild to moderate, and transient. No

serious adverse events were reported. On July 20 , the companies announced early positive update

from German Phase 1/2 COVID-19 vaccine study, including rst T Cell response data.

Recently, two of the companies’ four investigational vaccine candidates (BNT162b1 and BNT162b2)

received Fast Track designation from the U.S. Food and Drug Administration (FDA). This designation

was granted based on preliminary data from Phase 1/2 studies that are currently ongoing in the

United States and Germany as well as animal immunogenicity studies. Further data from the

th

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ongoing Phase 1/2 clinical trials of the four vaccine candidates will enable the selection of a lead

candidate and dose level for an anticipated large, global Phase 2b/3 safety and e cacy study that

may begin as early as later this month, pending regulatory approval.

If the ongoing studies are successful, P zer and BioNTech expect to be ready to seek Emergency

Use Authorization or some form of regulatory approval as early as October 2020. The companies

currently expect to manufacture globally up to 100 million doses by the end of 2020 and potentially

more than 1.3 billion doses by the end of 2021, subject to nal dose selection from their clinical trial.

In addition to engagements with governments, P zer and BioNTech have provided an expression of

interest for possible supply to the COVAX Facility, a mechanism established by Gavi, the Vaccine

Alliance, the Coalition for Epidemic Preparedness Innovations (CEPI) and World Health Organization

(WHO) that aims to provide governments with early access to a large portfolio of COVID-19

candidate vaccines using a range of technology platforms, produced by multiple manufacturers

across the world.

About P zer: Breakthroughs That Change Patients’ Lives

At P zer, we apply science and our global resources to bring therapies to people that extend and

signi cantly improve their lives. We strive to set the standard for quality, safety and value in the

discovery, development and manufacture of health care products, including innovative medicines

and vaccines. Every day, P zer colleagues work across developed and emerging markets to advance

wellness, prevention, treatments and cures that challenge the most feared diseases of our time.

Consistent with our responsibility as one of the world's premier innovative biopharmaceutical

companies, we collaborate with health care providers, governments and local communities to

support and expand access to reliable, a ordable health care around the world. For more than 150

years, we have worked to make a di erence for all who rely on us. We routinely post information

that may be important to investors on our website at www.P zer.com

(https://cts.businesswire.com/ct/CT?

id=smartlink&url=http%3A%2F%2Fwww.p zer.com%2F&esheet=52254092&newsitemid=202007220

05438&lan=en-US&anchor=www.P zer.com&index=1&md5=6f112a969d509e17034b14f144afa93f).

In addition, to learn more, please visit us on www.P zer.com (https://cts.businesswire.com/ct/CT?


05438&lan=en-

US&anchor=www.P zer.com&index=2&md5=45840dd0e78d45b4d317726bbddf29ec) and follow us

on Twitter at @P zer (https://cts.businesswire.com/ct/CT?

id=smartlink&url=https%3A%2F%2Ftwitter.com%2Fp zer&esheet=52254092&newsitemid=2020072

2005438&lan=en-US&anchor=%40P zer&index=3&md5=18c0aee73883336002d6bd4014593aa4)

and @P zer News (https://cts.businesswire.com/ct/CT?

id=smartlink&url=https%3A%2F%2Ftwitter.com%2Fp zer_news&esheet=52254092&newsitemid=20

Hide

App000376


200722005438&lan=en-

US&anchor=%40P zer+News&index=4&md5=12c74b1b7a29bc30b293f916acd426b4), LinkedIn


id=smartlink&url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fp zer&esheet=52254092&n

ewsitemid=20200722005438&lan=en-

US&anchor=LinkedIn&index=5&md5=5c910cab1a07517c3aa51d11b12574cd), YouTube


id=smartlink&url=https%3A%2F%2Fwww.youtube.com%2Fp zer&esheet=52254092&newsitemid=2

0200722005438&lan=en-

US&anchor=YouTube&index=6&md5=21f46ef83dcb14e72260d904ccd6d761) and like us on

Facebook at Facebook.com/P zer (https://cts.businesswire.com/ct/CT?

id=smartlink&url=https%3A%2F%2Fwww.facebook.com%2FP zer%2F&esheet=52254092&newsitem

id=20200722005438&lan=en-

US&anchor=Facebook.com%2FP zer&index=7&md5=fbc1709405a01e2ebc16d7eb0c201207).

P zer Disclosure Notice

The information contained in this release is as of July 22, 2020. P zer assumes no obligation to

update forward-looking statements contained in this release as the result of new information or

future events or developments.

This release contains forward-looking information about P zer’s e orts to combat COVID-19, the

BNT162 mRNA vaccine program, a collaboration between BioNTech and P zer to develop a

potential COVID-19 vaccine, an agreement with the United States to manufacture and deliver

BNT162 and other potential agreements, including their potential bene ts, manufacturing and

distribution and the expected timing of clinical trials and regulatory submissions, that involves

substantial risks and uncertainties that could cause actual results to di er materially from those

expressed or implied by such statements. Risks and uncertainties include, among other things, the

uncertainties inherent in research and development, including the ability to meet anticipated clinical

endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates,

regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new

preclinical or clinical trial data and further analyses of existing preclinical or clinical trial data; risks

associated with preliminary data; the risk that clinical trial data are subject to di ering

interpretations and assessments, including during the peer review/publication process, in the

scienti c community generally, and by regulatory authorities; whether and when data from the

BNT162 mRNA vaccine program will be published in scienti c journal publications and, if so, when

and with what modi cations; whether regulatory authorities will be satis ed with the design of and

results from these and future preclinical and clinical studies; whether and when any biologics

license applications may be led in any jurisdictions for any potential vaccine candidates under the

Hide

App000377


collaboration; whether and when any such applications may be approved by regulatory authorities,

which will depend on myriad factors, including making a determination as to whether the product’s

bene ts outweigh its known risks and determination of the product’s e cacy and, if approved,

whether any such vaccine candidates will be commercially successful; decisions by regulatory

authorities impacting labeling, manufacturing processes, safety and/or other matters that could

a ect the availability or commercial potential of any such vaccine candidates, including

development of products or therapies by other companies; manufacturing capabilities or capacity,

including whether the estimated numbers of doses can be manufactured within the projected time

periods indicated; whether and when a future production agreement with the United States will be

reached; whether and when other supply agreements will be reached; uncertainties regarding the

ability to obtain recommendations from vaccine technical committees and other public health

authorities regarding any such vaccine candidates and uncertainties regarding the commercial

impact of any such recommendations; and competitive developments.

A further description of risks and uncertainties can be found in P zer’s Annual Report on Form 10-K

for the scal year ended December 31, 2019 and in its subsequent reports on Form 10-Q, including

in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That

May A ect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are led

with the U.S. Securities and Exchange Commission and available at www.sec.gov


id=smartlink&url=http%3A%2F%2Fwww.sec.gov&esheet=52254092&newsitemid=20200722005438&

lan=en-US&anchor=www.sec.gov&index=8&md5=35c2145ba6c7bb794a9bd92f7c8dfb97) and

www.p zer.com (https://cts.businesswire.com/ct/CT?


05438&lan=en-

US&anchor=www.p zer.com&index=9&md5=0e0666bbb77fefe8cbc330b3153345db).

About BioNTech

Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering

novel therapies for cancer and other serious diseases. The Company exploits a wide array of

computational discovery and therapeutic drug platforms for the rapid development of novel

biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and

o -the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-speci c

checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep

expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its

collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases

alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with

multiple global pharmaceutical collaborators, including Genmab, Sano , Bayer Animal Health,

Hide

App000378


Genentech, a member of the Roche Group, Genevant, Fosun Pharma, and P zer. For more

information, please visit www.BioNTech.de (https://cts.businesswire.com/ct/CT?

id=smartlink&url=http%3A%2F%2Fwww.BioNTech.de&esheet=52254092&newsitemid=20200722005

438&lan=en-

US&anchor=www.BioNTech.de&index=10&md5=fb8be4528863006c664ea37b6856d4f7).

BioNTech Forward-looking statements

This press release contains “forward-looking statements” of BioNTech within the meaning of the

Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but

may not be limited to, statements concerning: BioNTech’s e orts to combat COVID-19; the timing to

initiate clinical trials of BNT162 and anticipated publication of data from these clinical trials; the

timing for any potential emergency use authorizations or approvals; the potential to enter into

additional supply agreements with other jurisdictions or the COVAX Facility; the potential safety and

e cacy of BNT162; the collaboration between BioNTech and P zer to develop a potential COVID-19

vaccine; and the ability of BioNTech to supply the quantities of BNT162 to support clinical

development and, if approved, market demand, including our production estimates for 2020 and

2021. Any forward-looking statements in this press release are based on BioNTech current

expectations and beliefs of future events, and are subject to a number of risks and uncertainties

that could cause actual results to di er materially and adversely from those set forth in or implied

by such forward-looking statements. These risks and uncertainties include, but are not limited to:

competition to create a vaccine for COVID-19; the ability to produce comparable clinical results in

larger and more diverse clinical trials; the ability to e ectively scale our productions capabilities; and

other potential di culties. For a discussion of these and other risks and uncertainties, see

BioNTech’s Annual Report on Form 20-F led with the SEC on March 31, 2020, which is available on

the SEC’s website at www.sec.gov (https://cts.businesswire.com/ct/CT?

id=smartlink&url=http%3A%2F%2Fwww.sec.gov&esheet=52254092&newsitemid=20200722005438&

lan=en-US&anchor=www.sec.gov&index=11&md5=4cc240b3adda2fc54d0e18f1cca607ef). All

information in this press release is as of the date of the release, and BioNTech undertakes no duty

to update this information unless required by law.

View source version on businesswire.com (http://businesswire.com):

https://www.businesswire.com/news/home/20200722005438/en/

(https://www.businesswire.com/news/home/20200722005438/en/)

P zer: Media Relations

Amy Rose

+1 (212) 733-7410

Amy.Rose@p zer.com (mailto:Amy.Rose@p zer.com)

Hide

App000379


(/)Copyright © 2002-2021 P zer Inc. All rights reserved. This information—including product information—is intendedonly for residents of the United States. The products discussed herein may have di erent labeling in di erent countries.

Investor Relations

Chuck Triano

+1 (212) 733-3901

Charles.E.Triano@P zer.com (mailto:Charles.E.Triano@P zer.com)

BioNTech:

Media Relations

Jasmina Alatovic

+49 (0)6131 9084 1513 or +49 (0)151 1978 1385

[email protected] (mailto:[email protected])

Investor Relations

Sylke Maas, Ph.D.

+49 (0)6131 9084 1074

[email protected] (mailto:[email protected])

Source: P zer Inc.

Hide

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Exhibit

App000381


App000382


App000383


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Exhibit

App000385


Log in

App000386


App000387


App000388


Contracts For Aug. 2, 2021

ARMY

P zer Inc., New York, New York, was awarded a $3,500,000,001 rm- xed-price contract for the

procurement of 500 million doses of COVID-19 vaccine for the purpose of international donation. Bids

were solicited via the internet with one received. Work will be performed in New York, New York, with

an estimated completion date of Dec. 31, 2022. Fiscal 2021 research, development, test and evaluation,

Army funds in the amount of $3,500,000,001 were obligated at the time of the award. U.S. Army

Contracting Command, Aberdeen Proving Ground, Maryland, is the contracting activity (W58P05-21-

C-0002). (Awarded July 30, 2021)

General Electric Aviation, Lynn, Massachusetts, was awarded a $208,162,355 rm- xed-price contract

for overhaul of the cold section module in support of the T700 engine. Bids were solicited via the

internet with two received. Work locations and funding will be determined with each order, with an

estimated completion date of Aug. 1, 2026. U.S. Army Contracting Command, Redstone Arsenal,

Alabama, is the contracting activity (W58RGZ-21-D-0065).

Weeks Marine Inc., Covington, Louisiana, was awarded a $15,697,708 rm- xed-price contract for

berm reconstruction at Ocean City, Maryland. Bids were solicited via the internet with three received.

Work will be performed in Ocean City, Maryland, with an estimated completion date of April 11, 2022.

U.S. Army Corps of Engineers, Baltimore, Maryland, is the contracting activity (W912DR-21-C-0020).

Keller North America Inc., Alpharetta, Georgia, was awarded a $9,118,588 rm- xed-price contract for

bluff stabilization at Natchez National Cemetery. Bids were solicited via the internet with four received.

Work will be performed in Natchez, Mississippi, with an estimated completion date of Aug. 1, 2022.

Fiscal 2021 Department of Veterans Affairs, National Cemetery Administration funds in the amount of

$9,118,588 were obligated at the time of the award. U.S. Army Corps of Engineers, Vicksburg,

Mississippi, is the contracting activity (W912EE-21-C-0008).

NAVY

General Dynamics Electric Boat Corp., Groton, Connecticut, is awarded a $225,117,921 modi cation to

previously awarded contract N00024-19-C-2125 for engineering, technical, design agent, and planning

yard support for operational strategic and attack submarines. The contract provides for drawings and

App000389


related technical data; design change documentation; logistics technical data; con guration

management; hull, mechanical and electrical engineering; submarine safety design review; non-

propulsion plant electrical system engineering; propulsion plant engineering; maintenance engineering;

re t/availability technical support; on-site support; con guration change program design and

installation support; con guration change program material support; submarine technical trade

support; training and facility support; research development test and evaluation program support;

research and development submarine/submersibles support; miscellaneous special studies; temporary

alteration support; modernization of submarine/submersible systems/subsystems; and

affordability/cost reduction technical support. Work will be performed in Groton, Connecticut (70%);

Kings Bay, Georgia (13%); Bangor, Washington (10%); Pearl Harbor, Hawaii (3%); North Kingston, Rhode

Island (2%); and Newport, Rhode Island (2%), and is expected to be completed by September 2023.

Fiscal 2021 other procurement, Navy funding in the amount of $3,104,008 will be obligated at time of

award and will not expire at the end of the current scal year. The Naval Sea Systems Command,

Washington, D.C., is the contracting activity.

Lockheed Martin Corp., Owego, New York, is awarded an $117,686,514 modi cation (P00002) to a

rm- xed-price order (N0001921F0841) against a previously issued basic ordering agreement

(N0001921G0017). This order provides non-recurring engineering and eld services representative

efforts to bring 12 MH-60R aircraft from standard Foreign Military Sales (FMS) con guration to a

Republic of Korea Navy con guration. Work will be performed in Stratford, Connecticut (38%); Best,

France (37%); Owego, New York (18%); and Portsmouth, Rhode Island (7%), and is expected to be

completed in November 2026. FMS funds in the amount of $117,686,514 will be obligated at time of

award, none of which will expire at the end of the current scal year. The Naval Air Systems Command,

Patuxent River, Maryland, is the contracting activity.

Seemann Composites LLC,* Gulfport, Mississippi, is awarded an $74,922,276 inde nite-

delivery/inde nite-quantity, cost-plus- xed-fee, and cost-plus-incentive-fee contract for design

engineering and manufacturing support. Work will be performed in Gulfport, Mississippi (60%);

Chesapeake, Virginia (20%); and Horsham, Pennsylvania (20%), and is expected to be completed by July

2026. Fiscal 2021 research, development, test, and evaluation (Navy) funding in the amount of $18,842

will be obligated at time of award for the rst order and not expire at the end of the current scal year.

This contract was competitively procured via the Beta.Sam.gov website, with three offers received. The

Naval Surface Warfare Center Carderock Division, Bethesda, Maryland, is the contracting activity

(N0016721D0010).

Lockheed Martin Corp., Fort Worth, Texas, is awarded a $51,793,127 cost-plus-incentive-fee contract.

This contract provides for program management support to include development of customer unique

capabilities in support of the continued development of the air system for the F-35 Lightning II Joint

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Strike Fighter program for a Foreign Military Sales (FMS) customer. Work will be performed in Fort

Worth, Texas (71%); Redondo Beach, California (13%); Melbourne, Florida (1%); and various

undisclosed locations outside the continental U.S. (15%), and is expected to be completed in January

2024. FMS customer funds in the amount of $18,000,000 will be obligated at time of award, none of

which will expire at the end of the current scal year. This contract was not competitively procured

pursuant to 10 U.S. Code 2304(C)(1). The Naval Air Systems Command, Patuxent River, Maryland, is the

contracting activity (N0001921C0040).

Lockheed Martin Corp., Owego, New York, is awarded a not-to-exceed unde nitized $34,400,000

modi cation (P00028) to a previously awarded, rm- xed-price contract (N0001919C0013). This

modi cation adds scope to provide integration and installation of a Hellenic Navy System con guration

on three USN8 time con guration remote sensors for aircraft. This modi cation also provides for

efforts on three replace in kind aircraft to bring the aircraft into a USN8 con guration. Additionally it

procures four Airborne Low Frequency Sonars in support of the MH-60R program for the Navy and

Foreign Military Sales (FMS) customers. Work will be performed in Best, France (46%); Owego, New

York (40%); Portsmouth, Rhode Island (9%); and Stratford, Connecticut (5%), and is expected to be

completed in April 2025. Fiscal 2021 aircraft procurement (Navy) funds in the amount of $1,300,976;

and FMS funds in the amount of $11,855,070 will be obligated at time of award, none of which will

expire at the end of the current scal year. The Naval Air Systems Command, Patuxent River, Maryland,

is the contracting activity.

DEFENSE MICROELECTRONICS ACTIVITY

Marvell Government Solutions LLC, Essex Junction, Vermont, is awarded a $98,216,265 ceiling increase

modi cation (P00019) to previously awarded HQ072720C4000 for Application Speci c Integrated

Circuit (ASIC) design services. The modi cation brings the total cumulative face value of the contract to

$212,348,848 from $114,132,583. Work will be performed at Burlington, Vermont, with an expected

completion date of March 31, 2022. The contract is being incrementally funded and $55,969,855 in

funds are being obligated at time of modi cation. The Defense Microelectronics Activity, McClellan,

California, is the contracting activity.

DEFENSE INFORMATION SYSTEMS AGENCY

Soliel LLC, Vienna, Virginia, was awarded a competitive 8(a) hybrid ( rm- xed-price/cost-plus- xed-fee)

contract for National Bureau of Investigation Service (NBIS) Development, Deployment and

Sustainment (DD&S-II). The face value of this action is $22,407,525, funded by scal 2021 operation

and maintenance; and research, development, test and evaluation funds. The total cumulative face value

of the contract is $22,407,525. Performance will be at both the government’s facilities and the

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contractor’s facilities. Proposals were solicited from 8(a) companies identi ed during market research,

and ve proposals were received from seven proposals. The period of performance is Aug. 5, 2021 –

Aug. 4, 2022, with four three-month option periods. The Defense Information Technology Contracting

Organization, Scott Air Force Base, Illinois, is the contracting activity (HC108421C0005).

AIR FORCE

Raytheon Intelligence and Space, Aurora, Colorado, has been awarded a $13,515,800 cost-plus-

incentive-fee contract modi cation (P00347) to the previously awarded contract FA8807-10-C-0001

for the Global Positioning System Next Generation Operational Control System (OCX). The contract

modi cation is for an equitable adjustment for COVID-19 impacts to OCX, including late government-

furnished equipment impacts and excusable delay overrun costs. The location of performance is Aurora,

Colorado. The work is expected to be completed by June 30, 2022. The contract is incrementally funded

with Space Force Research and Development funding, and no additional funds are being obligated at the

time of award. Total cumulative face value of the contract is $3,758,106,396. Space and Missile Systems

Center, Los Angeles Air Force Base, El Segundo, California, is the contracting activity.

DEFENSE ADVANCED RESEARCH PROJECTS AGENCY

Applied Physical Sciences Corp., Groton, Connecticut, has been awarded a $9,994,747 modi cation

(P00003) to previously awarded cost-plus- xed-fee contract HR001120C0038 to exercise the Contract

Line Item Number 0003 option to support a Defense Advanced Research Projects Agency research

project. Fiscal 2021 research and development funds in the amount of $9,994,747 are being obligated

at the time of award, with an estimated completion date of June 2022. The Defense Advanced Research

Projects Agency, Arlington, Virginia, is the contracting activity (HR001120C0138). (Awarded July 30,

2021)

*Small business

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Business Follow

U.S. Purchases Additional 50Million Pediatric Doses Of Covid-19 Vaccine, Pfizer Says

BREAKING | Oct 28, 2021, 08:38am EDT | 1,346 views

Robert Hart Forbes Staff

TOPLINE

The U.S. government purchased an additional 50 million doses of P zer's pediatric vaccine, which is ...

[+] AFP VIA GETTY IMAGES

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KEY FACTS

KEY BACKGROUND

BIG NUMBER

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TANGENT

FURTHER READING

Robert Hart Follow

I am a London-based reporter for Forbes covering breaking news. Previously, I have

worked as a reporter for a specialist legal publication... Read More

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Contracts For Nov. 22, 2021

ARMY

P zer Inc., New York, New York, was awarded a $1,400,000,001 modi cation (P00003) to contract

W58P05-21-C-0002 for an additional 200 million doses of P zer's COVID-19 vaccine for international

donation. Work will be performed in New York, New York, with an estimated completion date of June30,

2022. Fiscal 2022 research, development, test, and evaluation, Army funds in the amount of

$1,400,000,001 were obligated at the time of the award. U.S. Army Contracting Command, Aberdeen

Proving Ground, Maryland, is the contracting activity. (Awarded Nov. 19, 2021)

MEB General Contractors Inc., Chesapeake, Virginia, was awarded a $28,013,000 rm- xed-price

contract for fuel facility replacement. Work will be performed in Fort Hood, Texas, and is expected to be

completed by Feb. 7, 2023. Bids were solicited via the internet with ve received. Fiscal 2018 and 2021

military construction, Army; and 2022 military construction, Defense funds in the amount of

$28,013,000 were obligated at the time of award. The U.S. Army Corps of Engineers, Fort Worth, Texas,

is the contracting activity (W9126G-22-C-0003).

Radiance Technologies Inc.,* Huntsville, Alabama, was awarded a $25,808,362 cost-plus- xed-fee

contract for directed energy common test support. Bids were solicited via the internet with three

received. Work will be performed in Huntsville and Redstone Arsenal, Alabama, with an estimated

completion date of Nov. 21, 2026. Fiscal 2021 research, development, test and evaluation, Army funds

in the amount of $25,808,362 were obligated at the time of the award. U.S. Army Rapid Capabilities and

Critical Technologies Of ce, Redstone Arsenal, Alabama, is the contracting activity (W50RAJ-22-F-

0002).

Dyncorp International LLC, Fort Worth, Texas, was awarded a $8,529,070 modi cation (P00182) to

contract W58RGZ-19-C-0025 for worldwide aviation maintenance. Work will be performed in Fort

Campbell and Fort Knox, Kentucky; Fort Drum, New York; Sato Cano, Honduras; Germany; and

Thailand, with an estimated completion date of Nov. 30, 2022. Fiscal 2022 operation and maintenance,

Army; and Foreign Military Sales funds in the amount of $8,529,070 were obligated at the time of the

award. U.S. Army Contracting Command, Redstone Arsenal, Alabama, is the contracting activity.

CORRECTION: The Nov. 19, 2021, contract announcement for Dynetics Inc., Huntsville, Alabama

(W50RAJ-22-9-0001), for $478,598,908 incorrectly stated that all funds would be obligated at time of

award. The funds will be obligated incrementally by Other Transaction Authority modi cations.

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DEFENSE INTELLIGENCE AGENCY

General Dynamics Information Technology Inc., Falls Church, Virginia, was awarded a $829,235,847

xed-price, award-fee task order to provide all information technology help desk services for the

Defense Intelligence Agency (DIA). Work will be performed at Joint Base Anacostia-Bolling in

Washington, D.C., and other DIA sites, with an expected completion date of Jan. 27, 2032. Fiscal 2022

operations and management funds in the amount of $19,962 are being incrementally funded at the time

of award for base-year labor. This contract was a competitive acquisition, and ve offers were received.

The Virginia Contracting Activity, Washington, D.C., is the contracting activity (HHM402-21-D-

0016/0002).

NAVY

Lockheed Martin, Rotary and Mission Systems, Moorestown, New Jersey, is awarded an $114,606,157

cost-plus-incentive-fee, cost-plus- xed-fee, and cost-only modi cation to previously-awarded contract

N00024-13-C-5116 to exercise an option for AEGIS Combat System Engineering Agent efforts for the

design, development, integration, test and delivery of Advanced Capability Build 20. Work will be

performed in Moorestown, New Jersey, and is expected to be completed by December 2022. Fiscal

2021 other procurement (Navy) funds in the amount of $430,000 (53%); and scal 2022 research,

development, test, and evaluation (Navy) funds in the amount of $382,216 (47%) will be obligated at

time of award and will not expire at the end of the current scal year. The Naval Sea Systems Command,

Washington, D.C., is the contracting activity.

Raytheon Technologies, Portsmouth, Rhode Island, is awarded a $27,596,535 rm- xed-price

modi cation to previously awarded contract N00024-16-C-6423 to exercise options for the production

of the MK54 lightweight torpedo MOD 0 and MOD 1 common part kits and spare torpedo components.

This contract combines purchases for the U.S. government (67%); and the governments of Spain and

Brazil (33%) under the Foreign Military Sales (FMS) program. Work will be performed in Portsmouth,

Rhode Island; and Keyport, Washington (5%), and is expected to be completed by May 2025. Fiscal 2022

weapons procurement (Navy) funds in the amount of $18,234,431 (66%); FMS Spain and FMS Brazil

funds in the amount of $9,015,184 (33%), and scal 2021 weapons procurement (Navy) funds in the

amount of $346,920 (1%) will be obligated at time of award and will not expire at the end of the current

scal year. The Naval Sea Systems Command, Washington, D.C., is the contracting activity.

Rockwell Collins Inc., Cedar Rapids, Iowa, is awarded a $9,900,000 rm- xed-price, cost-plus- xed-fee

modi cation (P00011) to a previously awarded contract (N0042118C0042). This modi cation exercises

an option to provide for the ight management function application enterprise-wide license for all Navy,

Marine Corps, and Navy led joint program aircraft. Work will be performed in Cedar Rapids, Iowa, and is

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expected to be completed in July 2023. Fiscal 2022 aircraft procurement (Navy) funds in the amount of

$9,900,000 will be obligated at time of award, none of which will expire at the end of the current scal

year. The Naval Air Warfare Center Aircraft Division, Patuxent River, Maryland, is the contracting

activity.

AIR FORCE

Zapata Group Inc., Charlotte, North Carolina (FA4418-22-D-0007); and ADC Engineering Inc.,

Hanahan, South Carolina (FA4418-22-D-0006), were awarded a $19,000,000 multiple award,

inde nite-delivery/inde nite-quantity contract for architect-engineer services. The contract provides

for the development of master planning documents for construction and utility infrastructure, and to

accomplish studies. Work will be performed at Joint Base Charleston, South Carolina, and is expected to

be completed by May 21, 2027. This award is the result of a competitive acquisition in which 16 offers

were received. The 628th Contracting Squadron, Joint Base Charleston, South Carolina, is the

contracting activity.

Blue Canyon Technologies Inc., Lafayette, Colorado, was awarded a $14,609,337 not-to-exceed, cost-

plus- xed-fee type contract for the Space Situational Awareness (SSA) Micro-Satellite Bus (AgileSAT)

Program. This contract provides for the development and demonstration of a small satellite bus that can

operate and maneuver effectively for up to three years in orbits beyond the geosynchronous equatorial

orbit and has exible support for a broad range of payloads. Work will be performed in Lafayette,

Colorado, and is expected to be completed by Feb. 28, 2023. This award is the result of a competitive

acquisition via the Small Business Innovative Research Program. Fiscal 2021 research and development

funding in the amount of $1,600,000 is being obligated at the time of award. Air Force Research

Laboratory, Wright Patterson Air Force Base, Ohio, is the contracting activity (FA8650-22-C-9211).

DEFENSE LOGISTICS AGENCY

Jo-Kell Inc.,** Chesapeake, Virginia, has been awarded a maximum $11,103,552 inde nite-quantity,

rm- xed-price long-term contract for UH-60A helicopter special purpose electrical cable assembly

spare parts. This was a sole-source acquisition using justi cation 10 U.S. Code 2304 (c)(1), as stated in

Federal Acquisition Regulation 6.302-1. This is a ve-year contract with no option periods. Location of

performance is Virginia, with a Nov. 29, 2026, performance completion date. Using military service is

Army. Type of appropriation is scal 2021 through 2026 defense working capital funds. The contracting

activity is the Defense Logistics Agency Aviation, Richmond, Virginia (SPE4A6-21-D-0036).

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Defense Energy Syndicate LLC, Bronx, New York, has been awarded a maximum $9,803,682 xed-price

with economic-price-adjustment requirements contract for fuel system icing inhibitor. This was a

competitive acquisition with six responses received. This is a 30-month contract with a 90-day

carryover. Locations of performance are throughout Europe and the Middle East, with a June 30, 2024,

performance completion date. Using customer is Defense Logistics Agency Energy. Type of

appropriation is scal 2022 through 2024 defense working capital funds. The contracting activity is the

Defense Logistics Agency Energy, Fort Belvoir, Virginia (SPE602-22-D-0751).

*Small business

**Woman-owned small business

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Budget

Novel Coronavirus (COVID-19)To date, CDC received COVID-19 supplemental funding through:

Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (P.L. 116-123): P.L. 116-123 provided$2.2 billion to CDC to prevent, prepare for and respond to COVID-19 domestically and internationally.

Coronavirus Aid, Relief, and Economic Security (CARES) Act (P.L. 116-136): P.L. 116-136 provided CDC $4.3 billion andATSDR $12.5 million to prevent, prepare for and respond to COVID-19 domestically and internationally.

Paycheck Protection Program and Health Care Enhancement Act (P.L. 116-139): P.L. 116-139 provided $1.0 billion to CDCtransferred from the Public Health Social Services Emergency Fund (PHSSEF) to support surveillance, epidemiology,laboratory capacity expansion, contact tracing, public health data surveillance and analytics infrastructuremodernization, disseminating information about testing, and workforce support necessary to expand and improveCOVID–19 testing. In addition, $10.25 billion from the PHSSEF was awarded to health departments through the CDCEpidemiology and Laboratory Capacity program for testing and contact tracing.

Coronavirus Response and Relief Supplemental Appropriations Act, 2021 (P.L. 116-260): P.L. 116-260 provided $8.75billion to CDC to plan, prepare for, promote, distribute, administer, monitor, and track coronavirus vaccines to ensurebroad-based distribution, access, and vaccine coverage. On behalf of HHS, $19.11 billion from the PHSSEF was awardedto health departments through the CDC Epidemiology and Laboratory Capacity program for testing and contact tracing.

American Rescue Plan Act of 2021 (P.L. 117-2): P.L. 117-2 provided $11.52 billion to CDC to plan, prepare for, promote,distribute, administer, monitor, and track vaccines; strengthen vaccine con dence in the US, provide information andeducation, and improve rates of vaccination; strengthen and expand activities and workforce related to genomicsequencing, analytics, and disease surveillance; combat COVID and other emerging infectious disease threats, globalhealth security, global disease detection and response, global health protection, global immunization, and coordination;support surveillance and analytics infrastructure modernization initiatives and an early warning system; and encourageprimary prevention of mental and behavioral health conditions for health care professionals. On behalf of HHS, CDC willprovide $10 billion from the PHSSEF to states to support COVID-19 screening testing for teachers, sta and students toassist schools in reopening safely for in-person instruction.

CDC 24/7 Response to COVID-19

The CDC COVID-19 fact sheet provides an overview of CDC’s support for COVID-19 response activities on federal, state,local, territorial and tribal levels. It also highlights CDC’s current COVID-19 e orts.

CDC COVID-19 State, Tribal, Local, and Territorial (STLT) Funding

The CDC COVID-19 STLT Funding page shows COVID-19 funding by jurisdiction, award, and the four COVID-19 supplementalappropriations.

CDC COVID-19 Funding for Tribes

The CDC COVID-19 Funding for Tribes Fact Sheet provides information on the funding provided to tribal nations, consortia,and organizations for responding to COVID-19 across tribal communities.

CDC COVID-19 Global Response Fact Sheet

The CDC COVID-19 Global Response Fact Sheet provides an overview of the goals, objectives, activities, and spend plan ofCDC’s global response to COVID-19.

CDC COVID-19 Data Modernization Initiative Fact Sheet

The CDC COVID-19 Data Modernization Initiative Fact Sheet discuss how CDC is bringing together state, tribal, local, andterritorial (STLT) public health jurisdictions and our private and public sector partners to create modern, interoperable, andreal-time public health data and surveillance systems that will protect the American public.

CDC In Action: Accelerating and Supporting COVID-19 Vaccine Distribution

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The CDC is playing an essential role in the response to the COVID-19 pandemic, working 24/7 to protect the nation’s healthand ensure public health partners have the resources, guidance, and scienti c expertise to respond.

Paycheck Protection Program and Health Care Enhancement Act Fact Sheet

The Paycheck Protection Program and Health Care Enhancement Act Fact Sheet provides an overview of the criticalactivities (domestic preparedness, workforce capacity, laboratory capacity, and communication and analytics) in CDC’s planfor public health response and capacity building.

Page last reviewed: August 3, 2021

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Exhibit 1

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Exhibit 1

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From: Enlow, Courtney D. (CIV)To: Aaron Siri; Gabrielle PalmerCc: Elizabeth BrehmSubject: RE: PHMPT v. FDA, No. 21-cv-1058 (N.D. Tex.)Date: Wednesday, December 1, 2021 8:35:51 AM

Good morning Aaron,

With regard to PHMPT v. FDA, No. 21-cv-1058 (N.D. Tex.), FDA has now had the opportunity toassess the number of responsive pages and to estimate processing times for additional portions ofPlaintiff’s priority list. In light of that assessment, FDA proposes that it produce the non-exemptportions of the following records by the below dates:

• By December 13, 2021, FDA plans to produce publicly releasable information from:

o Plaintiff’s priority item #1- CRF files for site 1055 (~2,030 pages);

o Completion of Plaintiff’s priority item #5-

Four additional .txt files that were listed on p. 10 of the index;

Four additional SAS files (not specifically listed on Plaintiff’s priority list, but

mentioned as something Plaintiff was interested in).

o Publicly releasable information from the following additional sections of the original

Comirnaty BLA:

Section 2.5 – Clinical Overview (~333 pages)

Section 2.7.3 – Summary of Clinical Efficacy (~182 pages)

Section 2.7.4 – Summary of Clinical Safety (~344 pages)

• By December 30, 2021, FDA plans to produce publicly releasable information from Plaintiff’s

priority item #2 – CRF files for site 1081 (~3,380 pages);

• By January 18, 2022, FDA plans to produce publicly releasable information from Plaintiff’s

priority item #3 – CRF files for site 1096 (~2,937 pages); and


priority item #4 – CRF files for site 1128 (~3,452 pages).

Under this schedule, by the end of January 2022, FDA expects to have produced publicly releasableinformation from more than 12,000 pages of records and 10 unpaginated .txt or SAS data files. (Thispage and file count includes records produced to Plaintiff on November 17, 2021, and records thatwill be produced to Plaintiff later today.) FDA will also have completed production of seven of thefirst eight items on the priority list Plaintiff provided to FDA on November 4, 2021.

After the January 31, 2022 production, FDA proposes to make one production at the end of each

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subsequent month totaling a minimum the non-exempt portions of 500 pages. (For purposes ofcalculating a “page count” of data records that are not paginated, FDA proposes considering twentylines of spreadsheet data the equivalent of one page. For example, production of a spreadsheetcontaining 2,000 lines of data would be counted the equivalent of a 100-page PDF record.) To theextent feasible, FDA plans to continue to prioritize records from Plaintiff’s priority list. Although FDAproposes a minimum rate of 500 pages a month, FDA will continue to produce records at a fasterrate where feasible. Please let me know if Plaintiff is amenable to this proposed schedule. If so, I propose that the partiesfile a joint status report setting out the agreed-upon schedule and requesting that the Court cancelthe hearing set for December 14 and the briefing deadlines. Thanks,Courtney Courtney EnlowTrial AttorneyU.S. Department of JusticeCivil Division, Federal Programs Branch1100 L Street, N.W., Room 12102Washington, D.C. 20005(202) [email protected]

From: Enlow, Courtney D. (CIV) Sent: Wednesday, November 17, 2021 1:40 PMTo: Aaron Siri <[email protected]>; Gabrielle Palmer <[email protected]>Cc: Elizabeth Brehm <[email protected]>Subject: PHMPT v. FDA, No. 21-cv-1058 (N.D. Tex.) Good afternoon Aaron and Gabrielle, I’ve attached correspondence from FDA and a release of records in PHMPT v. FDA, No. 21-cv-1058(N.D. Tex.). Kindly confirm receipt. Thanks,Courtney Courtney EnlowTrial AttorneyU.S. Department of JusticeCivil Division, Federal Programs Branch

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1100 L Street, N.W., Room 12102Washington, D.C. 20005(202) [email protected]

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HEALTH NEWS

States with High Vaccination Rates CanStill Experience COVID-19 Surges —Here’s Why

Written by Bob Curley on November 28, 2021 — Fact checked by JenniferChesak

Places such as Vermont where cold weather has set in are seeing an increase in COVID-19 cases. Spencer Platt/Getty Images

The average daily number of new COVID-19 cases has been risingin the United States during the past month.

Many of those increases are being seen in states with highervaccination rates.

Experts say the onset of cold weather is a major factor as peoplestart gathering indoors more, allowing the novel coronavirus tocirculate easier.

uu Fact CheckedFact Checked

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They also note that new cases aren’t necessarily the bestindicators of the seriousness of the current state of the pandemic.Deaths and hospitalizations should be examined, too.

New COVID-19 cases are rising in a number of U.S. states again, includingsome with high rates of vaccination.

But weather may have as much to do with the trend than vaccinationrates, experts say.

The 7-day daily average of new COVID-19 cases had fallen below 50,000during the middle of the summer before increasing in August and thendecreasing again in early autumn, according to data compiled by theCenters for Disease Control and Prevention (CDC).

The upward trend has now started to reappear.

New daily COVID-19 cases have topped 100,000 three times this pastweek, with a 7-day average reaching about 94,000 new cases per day bymidweek last week.

In addition, 39 states experienced increases in COVID-19 cases during theweek that ended Nov. 21, according to data compiled by Reuters.

Among the states with rising caseloads:

Missouri: 102 percent increase

Connecticut: 85 percent increase

Michigan: 65 percent increase

Oklahoma: 49 percent increase

Massachusetts: 48 percent hike

Some of these states have some of the highest rates of vaccination in thecountry. More than 70 percent of Massachusetts and Connecticutresidents, for example, are fully vaccinated against COVID-19.

Meanwhile, some states with low rates of vaccination, such as Louisianaand Georgia, currently have some of the lowest per capita COVID-19 case

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rates.

“We went through the same cycle last year with different parts of thecountry… going up at different times,” Dr. Robert C. Bollinger, a professorof infectious diseases at Johns Hopkins University School of Medicine inBaltimore and a founding member of emocha Health.

a professor of infectious diseases, medicine, public health, and nursing aswell as director of the Center for Clinical Global Health Education at JohnsHopkins University School of Medicine in Baltimore, told Healthline.

“There are probably a number of factors contributing to the currentspike,” Dr. Karen Edwards, chair of the department of epidemiology andbiostatistics at the University of California, Irvine Program in Public Health,told Healthline. “Some of the most likely factors are that as the weathergets colder, more people are gathering indoors and in closer proximity toeach other, which facilitates transmission between individuals.”

“There may also be less adherence to mask wearing, good hygiene, andsocial distancing, which combined with more indoor activities, willincrease opportunities for infection, especially among the unvaccinated,”said Edwards.

She noted that there are still significant numbers of unvaccinated peopleeven in states with higher vaccination rates, “and are more likely to beinfected, have more severe illness, and contribute to the spikes.”

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Dr. Joseph Iser, a fellow of the American College of Preventive Medicine,told Healthline that the current increase in COVID-19 cases is likely to getworse in the coming months.

“If you’re looking at the flu season, it really doesn’t start until the cold oflate fall or early winter,” said Iser. “I think the COVID surge is going to lookpretty serious. I think it’s going to continue to rise until we get more adultsvaccinated, more adults to get boosters, and more kids ages 5 to 11 to getvaccinated.”

As for states that seem to be behind the curve of rising case rates despitelow vaccination rates, Iser said, “Give it time.”

“Once the cooler weather sets, we’re going to see an uptick in thoseplaces, too,” he predicted.

Waning immunity against COVID-19, among both vaccinated people andthose who previously contracted the coronavirus, may also be acontributing factor to the upward trend in cases, according to Bollinger.

“People who were vaccinated more than 6 months ago now need abooster,” Bollinger noted.

The prevalence of the highly infectious Delta variant also plays a role indriving cases upward, said Bollinger.

He said it’s likely that at least 90 percent of Americans will need to beimmune to the novel coronavirus before COVID-19 is brought undercontrol.

These concerns were paramount even before the announcement late lastweek about the emergence of the Omicron variant.

“Vaccination by itself is not enough to stop an infectious disease,” saidBollinger. “With such a high transmission rate, you need other measureslike masks and limits on indoor gatherings. It doesn’t take many

What the coming months may bring

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unvaccinated people to drive rates up when you have a highly infectiousdisease like this.”

Case rates don’t tell the whole story about the latest spike in infections,according to Iser.

Vaccinated people may be getting so-called “breakthrough infections”that add to the case count, but such cases tend to be milder, whereasunvaccinated people are still far more likely to develop severe COVID-19illnesses.

“Looking at case rates gives you a sense of transmissions in thatcommunity,” said Iser. “But if you want to see the seriousness of illnessyou need to look at hospitalizations and death rates.”

So, while there may seem to be a contradiction in states with lowervaccination rates reporting lower COVID-19 case rates, “there is not adisconnect between vaccination rates and the rates of hospitalization anddeath,” Bollinger said.

“Hopefully we’re not going to be in the same place as we were last yearin terms of the impact on the healthcare system,” he said.

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Cases aren’t the only indicator

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Yet with the COVID-19 death toll already topping 777,000 in the UnitedStates, Bollinger said the prospect of 1 million total deaths from COVID-19this winter or next spring seems likely “if we don’t really turn thingsaround.”

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Why Hospitalizations, Deaths May BeBetter Indicators of the COVID-19Pandemic Than New CasesWritten by Tony Hicks on November 21, 2021 — Fact checked by Maria Gifford

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CDC Newsroom

Statement from CDC Director Rochelle P. Walensky,MD, MPH on Today’s MMWR

Media StatementMedia Statement

For Immediate Release: Friday, July 30, 2021 Contact:Contact: Media Relations (404) 639-3286

On July 27th, CDC updated its guidance for fully vaccinated people, recommending that everyone wear a mask in indoorpublic settings in areas of substantial and high transmission, regardless of vaccination status. This decision was madewith the data and science available to CDC at the time, including a valuable public health partnership resulting in rapidreceipt and review of unpublished data.

Today, some of those data were published in CDC’s Morbidity and Mortality Weekly Report (MMWR), demonstrating thatDelta infection resulted in similarly high SARS-CoV-2 viral loads in vaccinated and unvaccinated people. High viral loadssuggest an increased risk of transmission and raised concern that, unlike with other variants, vaccinated people infectedwith Delta can transmit the virus. This nding is concerning and was a pivotal discovery leading to CDC’s updated maskrecommendation. The masking recommendation was updated to ensure the vaccinated public would not unknowinglytransmit virus to others, including their unvaccinated or immunocompromised loved ones.

This outbreak investigation and the published report were a collaboration between the Commonwealth of MassachusettsDepartment of Public Health and CDC. I am grateful to the commonwealth for their collaboration and rigorousinvestigation. I would also like to humbly thank the residents of Barnstable County who leaned in to assist with theinvestigation through their swift participation in interviews by contact tracers, willingness to provide samples for testing,and adherence to safety protocols following noti cation of exposure.

This outbreak investigation is one of many CDC has been involved in across the country and data from thoseinvestigations will be rapidly shared with the public when available. The agency works every day to use the best availablescience and data to quickly and transparently inform the American public about threats to health.

### U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

CDC works 24/7 protecting America’s health, safety and security. Whether disease start at home or abroad, are curable orpreventable, chronic or acute, or from human activity or deliberate attack, CDC responds to America’s most pressinghealth threats. CDC is headquartered in Atlanta and has experts located throughout the United States and the world.

Page last reviewed: July 30, 2021

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H E A LT H • C OV I D -1 9

BY M A R C O Q U I R OZ- G U T I E R R E ZN ove m b e r 26, 2 0 2 1 1 0 :4 6 A M P ST

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Evidence mounts thatOmicron is more infectious,less severe than Delta—butFauci, other experts warnagainst premature optimism

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COVID-19 Vaccine Booster ShotsUpdated Nov. 29, 2021

Everyone Ages 18 and Older Should Get a Booster Shot

NEWNEW Everyone ages 18 and older should get a booster shot

IF YOU RECEIVED P zer-BioNTech or Moderna

Who should get a booster:Who should get a booster: Everyone 18 years or older

When to get a booster:When to get a booster: At least 6 months after completing your primary COVID-19 vaccination series.

Which booster should you get?Which booster should you get? Any of the COVID-19 vaccines authorized in the UnitedStates.

IF YOU RECEIVED Johnson & Johnson’s Janssen

Who should get a booster:Who should get a booster: Everyone 18 years or older

When to get a booster:When to get a booster: At least 2 months after completing your primary COVID-19 vaccination.

Which booster should you get?Which booster should you get?Any of the COVID-19 vaccines authorized in the UnitedStates.

Choosing Your COVID-19 Booster ShotYou may choose which COVID-19 vaccine you receive as a booster shot. Some people may prefer the vaccine type that theyoriginally received, and others may prefer to get a di erent booster. CDC’s recommendations now allow for this type of mixand match dosing for booster shots.

Scheduling Your Booster ShotIf you need help scheduling your booster shot, contact the location that set up your previous appointment. If you need to getyour booster shot in a location di erent from where you received your previous shot, there are several ways you can nd avaccine provider.

What to Expect during and after Your Booster ShotAppointment

Bring your CDC COVID-19 Vaccination Record card to your booster shot appointment so your provider can ll in theinformation about your booster dose. If you did not receive a card at your rst appointment, contact the vaccination sitewhere you got your rst shot or your state health department to nd out how you can get a card.

You may experience side e ects after getting a COVID-19 vaccine. These are normal signs that your body is buildingprotection against COVID-19.

COVID-19

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Use v-safe to tell CDC about any side e ects. If you enter your booster shot in your v-safev-safe account, the system will sendyou daily health check-ins.

Frequently Asked Questions

Yes. COVID-19 booster shots are the same formulation as the current COVID-19 vaccines. However, in the case ofthe Moderna COVID-19 vaccine booster shot, it is half the dose of the vaccine people get for their primary series.

Are booster shots the same formulation as existing vaccines?

Yes. COVID-19 vaccines are working well to prevent severe illness, hospitalization, and death, even against the widelycirculating Delta variant. However, public health experts are starting to see reduced protection, especially among certainpopulations, against mild and moderate disease.

If we need a booster shot, are the vaccines working?

So far, reactions reported after getting a booster shot were similar to those of the two-shot or single-dose primary series. You can use v-safe to tell CDC about any side e ects. If you enter your booster shot in your v-safe account, the system will send you daily health check-ins. Fever, headache, fatigue and pain at the injection site werethe most commonly reported side e ects, and overall, most side e ects were mild to moderate. However, as withthe two-shot or single-dose primary series, serious side e ects are rare, but may occur.

What are the risks to getting a booster shot?

Yes. Everyone is still considered fully vaccinated two weeks after their second dose in a two-shot series, such as theP zer-BioNTech or Moderna vaccines, or two weeks after a single-dose vaccine, such as the J&J/Janssen vaccine.

Am I still considered “fully vaccinated” if I don’t get a booster shot?

Data Supporting Need for a Booster Shot

Although COVID-19 vaccination remains e ective in preventing severe disease, recent data [1 MB, 68 pages] suggestvaccination becomes less e ective over time, especially in people aged 65 and older and at preventing infection or milderillness with symptoms.

The recent emergence of the Omicron variant (B.1.1.529) further emphasizes the importance of vaccination, boosters,and prevention e orts needed to protect against COVID-19. Early data from South Africa suggest increasedtransmissibility of the Omicron variant and the potential for immune evasion.

Emerging evidence also shows that among healthcare and other frontline workers, vaccine e ectiveness against COVID-19 infections is also decreasing over time.

This lower e ectiveness is likely due to the combination of decreasing protection as time passes since getting vaccinated,as well as the greater infectiousness of the Delta variant.

Studies show after getting vaccinated against COVID-19, protection against the virus and the ability to prevent infectionwith variants may decrease over time.

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Data from clinical trials showed that a booster shot increased the immune response in trial participants who nished a P zer-BioNTech or Moderna primary series 6 months earlier or who received a J&J/Janssen single-dose vaccine 2 months earlier.With an increased immune response, people should have improved protection against COVID-19, including the Delta variant.For P zer-BioNTech and J&J/Janssen, clinical trials also showed that a booster shot helped prevent COVID-19 with symptoms.

Related Pages

Understanding How COVID-19 Vaccines Work

Ensuring COVID-19 Vaccines Work

Frequently Asked Questions about COVID-19 Vaccination

Examples of Workers Who May Get P zer-BioNTech Booster Shots

COVID-19 Vaccines for Moderately to Severely Immunocompromised People

For Healthcare and Public HealthConsiderations for Use of a COVID-19 Vaccine Booster Dose

More Information

ACIP Presentation Slides, November 19, 2021

ACIP Presentation Slides, October 21, 2021

ACIP Presentation Slides, September 22–23, 2021

Last Updated Nov. 29, 2021

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Data from clinical trials showed that a booster shot increased the immune response in trial participants who nished a P zer-BioNTech or Moderna primary series 6 months earlier


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Clinical trials are crucial to helping researchers understand the safety and effectiveness of an investigational drug. Pfizer’s commitment to openness and transparency includes all aspects of research and development behind our products, including clinical trials. Enhanced transparency in clinical trials fosters trust among research participants, health care professionals, and biopharmaceutical companies, while increasing knowledge of potential new treatments in development. Transparency also enables patients, physicians, and others to see the progress being made to address unmet medical needs. Pfizer’s policies support clinical trial transparency to advance scientific knowledge and public health, while balancing the need to protect participant privacy and respect the regulatory process.

The study of how a medicine works in people is a pivotal step in the research and development process of new treatments for diseases and medical conditions. Researchers spend years in the laboratory before conducting carefully controlled studies in research participants, known as clinical trials. Regulatory authorities issue rules regarding the conduct of clinical trials and the sharing of the results of these studies to make sure that research sponsors abide by a clearly defined set of standards. A drug is approved only when the data, collected through clinical trials, prove that the drug is both safe and effective. Clinical trials help answer questions about risks, benefits, and side effects of a potential new treatment. In addition, clinical trials are also conducted on already approved medicines to increase knowledge about their potential uses, benefits, safety, and long-term effects.

Transparency of clinical trials is an important issue to patients, the research community, and policymakers. Certain jurisdictions require registration and posting of summary results from clinical trials of regulated medical products. To facilitate these requirements and recommendations, public registries, such as ClinicalTrials.gov and EudraCT, have been created for clinical trials conducted in the U.S. and Europe, respectively.1,2 The World Health Organization International Clinical Trials Registry Platform is a voluntary global network that was established to provide a single point of access to multiple clinical trial databases, conforming to a set of international standards for clinical trial registries.3

An increasing call to have access to detailed clinical trial data has resulted in several additional regulations, policies, and clinical trial sponsor-led efforts. In July 2013, Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) jointly published commitments to responsible data sharing practices by biopharmaceutical companies.4 In 2016, the European Medicines Agency (EMA) released a policy on the requirements for publishing clinical data to support regulatory applications.5 The Food and Drug Administration (FDA) has explored policies designed to use and share de-identified and masked trial data from marketing applications.6 In 2018, FDA launched a pilot program to assess the feasibility of releasing portions of clinical study reports (CSRs) in an effort to provide usable summaries of clinical evidence.7 The International Committee of Medical Journal Editors (ICMJE) has a policy that medical journals require the registration of clinical trials as a condition of publication.8

Pfizer invested more than $8 billion during 2018 in the research and development of new products,9 and as of November 30, 2019 had 96 products in its development pipeline.10 Pfizer currently has 205 open, ongoing trials registered on www.ClinicalTrials.gov.11

Pfizer believes it is important for researchers, trial participants, regulators, and others acting in the best interest of patients to have access to clinical trial information to advance medical understanding and progress. It is also important that this access protect participant privacy, preserve regulatory authority, and maintain incentives for those who generate research data.

Pfizer offers access to the clinical data gathered in company-sponsored clinical trials, in the hope and belief that greater openness may accelerate medical progress and benefit patient outcomes and public health. Pfizer publicly shares results from our clinical trials, whether the results are positive, neutral, or negative. We also share data gathered in clinical trials we sponsor with trial participants, researchers, and others. Pfizer’s data access policies and practices meet or exceed the five transparency principles endorsed by PhRMA and EFPIA.8

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Pfizer’s clinical trial results and data sharing approaches include:

Regulatory Requirements: Pfizer is committed to meeting or exceeding regulatory requirements for the registration of our clinical trials and provision of results upon completion. Public Access to Clinical Study Information: Pfizer publicly posts electronic synopses of Clinical Study Reports (CSRs) submitted to regulators, relating to approved products.12 These reports include summary results for all primary and secondary endpoints with any personally identifiable information removed. Sharing Results with Clinical Trial Participants: Pfizer believes that data collected during a clinical trial should be returned to the study participants, if they wish and where permitted, so that they may better understand the research in which they participated and use the data gathered about their health. Pfizer returns clinical trial data to participants along with summaries of aggregate clinical trial results in easy-to-read, non-technical language so that they can understand why the study was done, how it was done, and the results. Data Sharing with Researchers: Pfizer provides access to de-identified patient-level data upon request from qualified scientific and medical researchers who have submitted a scientifically valid research proposal. Requests are managed through the global clinical research data sharing platform, Vivli.13 Publication of Clinical Trial Results: Pfizer submits the primary results of all interventional clinical studies for publication in peer-reviewed biomedical journals within 18 months of study completion, regardless of the outcome.

Clinical trials provide valuable information to help regulators ensure new medicines are safe and effective prior to being prescribed to patients. Trials also help biopharmaceutical companies, regulators, and public health officials monitor the safety and effectiveness of treatments already available to patients.

Transparency in clinical trials engenders trust between participants, health care professionals, and biopharmaceutical companies and increases patient knowledge of available medications, as well as potential new treatments in development. Pfizer’s policies are designed to promote effective and ethical collaborations and build trust throughout the health care system. Finally, transparency in clinical trials enables monitoring of the progress being made to address unmet medical needs in our health care system.

1 See: www.clinicatrials.gov. 2 See: eudract.ema.europa.eu. 3 See: www.who.int/ictrp/en. 4 PhRMA & EFPIA phrma.org/sites/default/files/pdf/PhRMAPrinciplesForResponsibleClinicalTrialDataSharing.pdf. 5 See: www.ema.europa.eu/en/human-regulatory/marketing-authorisation/clinical-data-publication. 6 Federal Register notice, Docket No. FDA-2013-N-0271, Availability of Masked and De-identified Non-Summary Safety and Efficacy Data; Request for Comments; June 4, 2013. Available at http://www.gpo.gov/fdsys/pkg/FR-2013-06-04/html/2013-13083.htm. 7 See: www.fda.gov/drugs/development-approval-process-drugs/clinical-data-summary-pilot-program.8 ICMJE Clinical Trials Recommendations: http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html. 9 Pfizer 2018 Financial Report available at: s21.q4cdn.com/317678438/files/doc_financials/Annual/2018/2018-Financial-Report.pdf. 10 See: www.pfizer.com/science/drug-product-pipeline. 11 National Institutes of Health. ClinicalTrials.gov. Available at http://www.clinicaltrials.gov/ct2/search, accessed November 7, 2019. 12 See: www.pfizer.com/research/research_clinical_trials/trial_results.13 See: vivli.org.

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BMJ Evidence- Based Medicine Month 2021 | volume 0 | number 0 | 1

EBM analysis

Transparency of COVID-19 vaccine trials: decisions

without data

Sarah Tanveer ,1 Anisa Rowhani- Farid ,

1

Kyungwan Hong,1 Tom Jefferson ,

2 Peter Doshi

1

General medicine

1Department of Pharmaceutical Health Services Research, University of Maryland Baltimore, Baltimore, Maryland, USA2Department for Continuing Education, University of Oxford, Oxford, UK

Correspondence to: Dr Peter Doshi, Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, Baltimore, MD 21201, USA; pdoshi@ rx. umaryland. edu

10.1136/bmjebm-2021-111735

To cite: Tanveer S, Rowhani- Farid A, Hong K, et al. BMJ Evidence- Based Medicine Epub ahead of print: [please include Day Month Year]. doi:10.1136/bmjebm-2021-111735

© Author(s) (or their employer(s)) 2021. No commercial re- use. See rights and permissions. Published by BMJ.

Transparency in clinical trials: an

established norm across sectorsAccess to data for drugs and vaccines has histor-ically been fairly limited to journal article publi-cations and hard- to- access and difficult to read regulatory reports.1 But the past decade has witnessed strides in clinical trial data transpar-ency. A wide range of institutions, from pharma-ceutical companies, government agencies, trade organisations, journals and not- for- profit organ-isations, have all acknowledged the importance of data sharing, including the release of deidentified individual participant data. Many policies, regu-lations and platforms now exist to facilitate data access, including landmark transparency policies from the European Medicines Agency (EMA)2 3 and Health Canada.4 Both regulators now post on their websites, sections of the licensure dossier received by the industry (https:// clinicaldata. ema. europa. eu/ and https:// clinical- information. canada. ca/). There are also industry and academic platforms to facilitate third- party access to trial data and documents, including Clin ical Stud yDat aRequest. com, Yale University Open Data Access (YODA) Project and Vivli.5 In 2013, the US and European industry trade organisations endorsed a joint statement on clinical trial data sharing, making a series of commitments that ‘recognise the impor-tance of sharing clinical trial data in the interest of patients, healthcare and the economy”6 In 2015, the US Institute of Medicine similarly endorsed benefits of sharing clinical trial data, emphasising that ‘verification and replication of investigators’ claims’ were essential to the scientific process, and noting the numerous benefits to stakeholders ‘including payers of healthcare as well as patients, their physicians and researchers.’7

Why we need access to COVID-19 vaccine

trial data and documentsClinical trial transparency is always important, but is especially critical during the COVID-19 pandemic (or any public health emergency) where regulatory decisions are being made quickly by government health officials, novel vaccine plat-forms are being used, vaccines are being adminis-tered widely and taxpayer funds have contributed heavily to research and development. Crit-ical appraisal of clinical trials is vital to inform decision making at the personal, professional

and governmental level, but cannot be credibly performed on journal publications alone.8 9 Access to clinical trial data and related trial documents (see box 1) allows for independent and informed assessment of trials. By understanding details of how studies were designed and how data were collected, one can understand if endpoints were reliably operationalised and measured. Similarly, release of underlying data from clinical trials allows for independent verification of results, assessment of heterogeneity of treatment effects for specific subgroups, and facilitates the forma-tion of new research questions.10

There are specific issues in COVID-19 vaccine trials that merit scrutiny. Consider blinding, an essential feature in randomised trials investigating efficacy against subjective endpoints, as in the COVID-19 vaccine trials. Assessing the reliability of blinding involves analysing endpoint defini-tions and data collection. The primary endpoint in many trials is laboratory- confirmed, symptomatic

Summary box

Data transparency has become a well- established norm in biomedical research, and is especially important for broadly used public health interventions like COVID-19 vaccines.

Tax payers helped fund COVID-19 vaccine trials and should have the right to access the results.

There is inadequate availability of COVID-19 vaccine trial documents and data; individual participant data will not be available for months, perhaps years, for most vaccines.

Widespread use of interventions without full data transparency raises concerns over the rational use of COVID-19 vaccines.

Trial transparency must start early and be continuous. Trial protocols should be released once finalised, before trial results are reported, and should be accompanied with the release of trial documents and data before clinicians and the public make decisions regarding product use.

by copyright. on August 10, 2021 at H

ealth Sci & Hum

an Services Library. Protectedhttp://ebm

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COVID-19. However, prior to the release of trial protocols, few details were known about this endpoint. Registry entries were vague (eg, Pfizer’s largest study11 only stated ‘confirmed COVID-19’ as one of 35 primary outcome measures), leaving unclear how the definition was operationalised. While the subsequent release of some protocols addressed some questions, it raised new questions that can only be answered with underlying data. Protocols make clear that the symptomatic component of the primary endpoint was reported by trial participants, typically via a smartphone app, and defined by one or more signs and symptoms, many of which were subjective (eg, in Pfizer’s trial, COVID-19 symptoms included at least one of the following: fever, cough, shortness of breath, chills, muscle pain, loss of taste or smell, sore throat, diarrhoea or vomiting.) The fact that the placebo was saline and the vaccines cause short term adverse events in the majority of people raises concerns about unofficial unblinding—that is, the ability of trial participants and investigators to make educated guesses as to treatment allocation. Only a thorough analysis of the underlying individual participant data will allow for an exploration of the extent to which unofficial unblinding may have occurred and biased data collection for the primary endpoint. Access to data would also allow for straightforward replication studies, perhaps particularly important when real- world results appear incompat-ible with reported trial results. For example, at the time of writing (27 June 2021), Seychelles, Mongolia, Bahrain, Uruguay, and Chile were experiencing COVID-19 outbreaks despite high uptake of WHO- authorised vaccines.

In addition, trial protocols from Pfizer and Moderna indicate that event adjudication committees were involved in counting COVID-19 cases. Considering that the primary endpoint was defined as a positive lab test and patient- reported symptoms, it is unclear how an adjudication committee might affect the primary endpoint evaluation process. Transparency of the committee’s charter may provide additional detail on what data committee members had access to in forming their judgements (eg, did they have access to data on patients’ symptoms in the first week after vaccination, when vaccine- related adverse events could be expected?), and what criteria they used to form their judgements. Access to such documents, therefore, is also important.

Regarding adverse events, detailed narratives of serious adverse events that occurred in a trial are a standard element found within clinical study reports and can enable a more thor-ough understanding of potential harms. Patterns in adverse

Box 1 Continued

Document that describes the quality of the placebo and investigational product, how the product(s) were manufactured, non- clinical and clinical study results. An Investigational Medicinal Product Dossier is required for all clinical trials conducted in the European Union.

Investigator’s Brochure (IB):A living document containing a summary of the clinical and nonclinical data of an investigational product, including its pharmacology, pharmacokinetics, toxicology and adverse event profile, among other items.

Sources: Restoring Invisible and Abandoned Trials (RIAT) declaration,31 RIAT Support Center Glossary.32

Box 1 Types of trial documents

Case report forms (CRFs)The original paper or electronic forms on which individual participants’ data (demographic, efficacy measurements, adverse events, etc) are recorded during the clinical trial. These documents contain structured fields which make it easier to analyse and report trial data. Access to blank case report forms (CRFs) allows for independent evaluation of how data were collected and endpoints were operationalised.

Clinical study reports(CSRs)

Unabridged, structured report of a clinical study written for regulators.30 A complete clinical study reports (CSRs), including study appendices, includes documentation of trial design, results of trial included adverse events, trial protocol, statistical analysis plans and blank CRFs. CSRs on average span thousands of pages, making them a rich source of information. European Medicines Agency and Heath Canada are the only two regulatory agencies that publish CSRs at this time.

Certificate of analysis

Provides a description of the chemical analysis and physical appearance of the study interventions actually used in the trial (both experimental and comparators).

Protocol

Document written prior to study start date which details plans on how the study will be conducted, analysed and reported. Any changes or deviations from the trial protocol should be tracked and provided, with a rationale for the change, in the form of a formal protocol amendment.

Statistical analysis plan (SAP)

A written plan of how trial data will be analysed and which statistical methods and definitions will be used.

Informed consent form (ICF)A document required to be provided to study subjects that contains information related to the description of the study, purpose, study intervention(s), any procedures, adverse events, risk and benefits, compensation and rights of participants enrolled in the study.

Serious adverse event (SAE) narratives

Unstructured paragraphs of text providing details and context of the serious adverse events that occurred in study participants. Narratives are usually contained within a CSR.

Electronic individual participant data (IPD)

Complete electronic computerised dataset for each participant in the trial which allows for full replication of study findings using statistical software. Complete CSRs also contain participant level data, mostly in appendices, but these are in text (not dataset) form as individual line listings.

Investigational Medicinal Product Dossier (IMPD)

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events can be explored through access to electronic individual participant- level data.

What data have been released

For eight COVID-19 vaccines being used, or under consideration for use globally (Pfizer, Moderna, Oxford/AstraZeneca, Janssen/

Johnson & Johnson, Novavax, Gamaleya Institute, Sinopharm and Sinovac), we evaluated the public availability of a variety of important pre- study documents (eg, trial protocol, statistical anal-ysis plan, blank informed consent form, blank case report form, data monitoring board charter, and event adjudication committee charter) and post- study documents (eg, press releases with trial

Table 1 Currently available COVID-19 vaccine trial data for selected trials

Trial ID; no enrolled; included agesPre- study documents

Post- study documents† Total pages available§Press release Pub CSR Other‡ IPD

Pfizer BNT162b2 mRNA vaccine

NCT04368728; n=43 998; 12–85 years Protocol, SAP, Blank CRF

Press release 1, 2, 3

Pub 1,2,3 CSR Other No 3880

NCT04713553; n=1530; 12–50 years None No N/A: trial ongoing 0

NCT04816643; n=4644; 6 months to 11 years

None No N/A: trial ongoing 0

Moderna mRNA-127 vaccine

NCT04470427; n=30 420; ≥18 years Protocol, SAP Press release Pub No Other No 3293

NCT04811664; n=37 500; 18–26 years None No N/A: trial ongoing 0

NCT04796896; n=6750; 6 months to 12 years


Oxford/AstraZeneca ChAdOx1 vaccine

ISRCTN89951424; n=10 300; ≥18 years Protocol Press release Pub1¶, 2¶

No No No 123

NCT04400838; n=12 390; ≥18 years Protocol Press release Pub1¶, 2¶

No No No 214

ISRCTN15638344; n=300; 6–17 years None No N/A: trial ongoing 0

Janssen (Johnson & Johnson) Ad26.COV2.S vaccine

NCT04505722; n=44 325; ≥18 years Protocol, SAP, Blank ICF

Press release Pub No No No 530

NCT04535453; n=1210; 12 to 55, ≥65 years


NCT04614948; n=30 000; ≥18 years Protocol No N/A: trial ongoing 166

Novavax SARS- CoV-2 rS/Matrix- M1 Adjuvanted vaccine

NCT04611802; n=30 000; ≥18 years Protocol No N/A: trial ongoing 128

NCT04368988; n=1419; 18–84 years Protocol, SAP Press release N/A: trial ongoing 189

NCT04583995; n=15 187; 18–84 years Protocol, SAP Press release Pub No No No 128

Gamaleya Research Institute Sputnik V/Gam- COVID- Vac vaccine

NCT04530396; n=33 758; ≥18 years None Press release Pub No No No 11

NCT04741061; n=6000; ≥18 years None No N/A: trial ongoing 0

NCT04642339; n=2000; ≥18 years None No N/A: trial ongoing 0

Sinopharm (BIBP) vaccine

ChiCTR2000032459; n=2128; ≥3 years None No Pub No No No 13

NCT04510207; n=45 000; ≥18 years Protocol, SAP No Pub No No No 102

NCT04612972; n=12 000; ≥18 years None No N/A: trial ongoing 0

Sinovac (CoronaVac) vaccine

NCT04456595; n=12 688; ≥18 years Protocol Press release Pub No No No 201

NCT04551547; n=552; 3–17 years None No Pub No No No 22

NCT04582344; n=13 000; 18–59 years Protocol Press release No No No No 57

Data current as of 27 June 2021.

*Pre- study documents include: protocol, statistical analysis plan, blank informed consent form, blank case report form, data monitoring board charter, event adjudication committee charter, investigational medicinal product dossier and investigator’s brochure.

†Post- study documents include: press releases (that contain any results), journal publication (including pre- prints), clinical study report and individual participant data.

‡Other includes documents released by Health Canada and EMA other than the CSR.

§Total pages available excludes press releases. Access to the dataset used to determine page count for trials where additional data were available through Health Canada and the European Medicines Agency is available in the Zenodo repository (http://doi.org/10.5281/zenodo.4737417).

¶Pooled trial analysis publication listed if there were no individual trial publications.

CRF, case report form; CSR, clinical study report; EMA, European Medicines Agency; ICF, informed consent form; IPD, individual participant data; n, number enrolled in trial; N/A, not applicable; Pub, journal publication ; SAP, statistical analysis plan.


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results, journal publication, clinical study report and individual participant data availability) at the time of writing (27 June 2021). We counted the total number of pages available as a crude proxy for the level of detail, as some documents, like clinical study reports, can be highly variable in length depending on the avail-ability of appendices.

The overall picture is one of varied transparency. While several trials have at this point published protocols and statistical analysis plans along with the study publications, with some even released while the trials were underway, many key trial documents remain inaccessible (table 1). For example, a WHO report found that out of 86 clinical trials for 20 COVID-19 vaccines, 12% of clinical trial protocols were made publically available.12 In our analysis, trial protocols and informed consent forms were not available for trials involving special populations such as children (NCT04816643) and pregnant women (NCT04754594). And despite vaccine rollout, electronic individual participant data is not available for most trials.12 Some sponsors, such as Moderna, have sent mixed messages on whether they even intend to share data, while others, such as Pfizer and Sinopharm, indicate they will not even begin accepting data requests for many months or years (table 2). In other cases, trialists have indicated very narrow time frames for sharing data, for example, ‘beginning 3 months and ending 1 year after publication’ (ChiCTR2000032459).13

The greatest availability of data at present comes from the EMA, Health Canada, and Japanese Pharmaceuticals and Medical Devices Agency which have released thousands of pages from company submissions for COVID-19 vaccines, far exceeding what is available elsewhere. The Food and Drug Administration (FDA) does not routinely make any industry documents it receives publicly available. It should be noted, however, that the EMA and Health Canada’s commitment to transparency does not necessarily equate with the public availability of critical study documents.

Judging from the availability of documents, regulators them-selves appear to be receiving less complete and granular data than normal due to the compressed timeline from study start to regula-tory decision making. For example, in July 2020, Canada granted emergency approval for the use of remdesivir, a drug used for the treatment of COVID-19, without receiving a copy of the clinical study report.14 This is also the case for the Moderna vaccine, for which a variety of trial documents have been posted by Health Canada and the EMA, but not the clinical study report.15 For Cuba, Russia, India and China state- developed vaccines, access to data prior to regulatory approval is even less clear.16

The world’s most used COVID-19 vaccines: Sinovac and Sinopharm

Sinovac and Sinopharm, developed by Chinese pharmaceutical companies, account for the majority of vaccines being in Asia, South America, the Carribean and Africa.17 They are authorised by the WHO and included in the WHO COVID-19 Vaccines Global Access initiative. However, transparency of trial data and docu-ments is extremely limited, similar to other COVID-19 vaccines. Because neither Chinese vaccine has thus far been authorised by the EMA, Health Canada, or the Japanese Pharmaceuticals and Medical Devices Agency (the three regulators publishing data to their websites), there is also no expectation that data on these vaccines will become publicly available via regulators (table 3). Sinovac vaccines have been administered for nearly 1 year (since July 2020), and still have yet to publish clinical trial data (as at 27 June 2021). Trial results have largely been limited to government media reports and press releases.18

Transparency of regulatory decision making

Apart from data and documents tied to a specific trial, credible analysis and interpretation of data may require understanding regulatory decision making. For example, the fact that many

Table 2 Timing of release of individual participant data from COVID-19 vaccine trials

Phase 3 trialProtocol released before results released?

Pledge to share IPD

Estimated date of availability(based on data sharing statement in protocol or publication)

Pfizer phase 2/3; 43 998 participants (NCT04368728)

Yes Yes April 2025, based on statement in trial protocol that data will be made available ‘24 months after study completion’

Moderna phase 3; 30 420 participants(NCT04470427)

Yes Unclear October 2022, based on statement in trial publication that data “may be available … once the trial is complete”

Oxford/AstraZeneca phase 3; 10 300 participants(ISRCTN89951424)

No Yes December 2021, based on statement in trial publication that trial data ‘will be made available when the trials are complete’

Janssen (Johnson & Johnson) phase 3; 44 325 participants(NCT04505722)

Yes Yes Unclear. April 2021 publication suggested data availability will begin ‘with publication,’ but as of June, still not listed on Yale Open Data Access Project website.

Novavax phase 3; 30 000 participants(NCT04611802)

Yes No* We could not locate any other written statement regarding patient- level data sharing. It is not discussed in the trial protocol or publication.

Gamaleya Research Institute phase 3; 33 758 participants(NCT04530396)

No Yes* May 2021, based on statement in trial publication that data will be made available ‘on completion of clinical trials’

Sinopharm phase 3; 45 000 participants(NCT04510207)

No Yes December 2022, based on statement in trial publication that data will be available between December 2022 and December 2027, with reasonable request to the sponsor and principal investigator.

Sinovac phase 3; 13 000 participants (NCT04582344)

Yes No* We could not locate any other written statement regarding patient- level data sharing. It is not discussed in the full- length study protocol. Also, a structured summary of study protocol states ‘Not applicable’ under the availability of data and material.


*According to the ‘Plan to Share IPD’ field in the ClinicalTrials.gov entry.

IPD, individual participant data.


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experts had originally believed the trials were designed to study a reduction in hospitalisation, intensive care utilisation and death,19 points to a need to better understand the rationale for primary endpoint selection. Regulators played a major role in shaping this. An FDA guidance document from June 2020, before phase 3 trials commenced, stated that laboratory- confirmed COVID-19 (of essentially any severity) was an acceptable primary endpoint. But there remains limited transparency on the rationale for the selec-tion of this endpoint: why was it chosen? What other endpoints were considered? More information about the internal delibera-tions is essential to understand whether the decisions made were reasonable.20

Additionally, there is a need for transparency around any deliberations regarding the length of follow- up necessary to adequately assess efficacy and safety prior to licensure. Longer follow- up for investigational products such as COVID-19 vaccines and therapeutic agents are necessary to evaluate duration of protection and ensure public and professional confidence.21 The International Coalition of Medicines Regulatory Authorities (ICMRA), a global collaborative coalition of 30 medicine regu-lators including the FDA, Health Canada and EMA, published a statement in November 2020 stating that follow- up for treatment

and placebo arms should continue ‘for as long as possible after any regulatory approval’ and recommended a follow- up period of ‘at least 1 year or more from completion of assigned doses’.22 Despite this, placebo controlled follow- up, originally planned for 2 years in many trials, was eliminated after a few months, when manufacturers began offering vaccine to placebo recipients within weeks of receiving emergency use authorisations. (Debates took place regarding the ethics of denying placebo recipients vaccine, and proposals to redesign the trials as cross- over trials were not taken up).23 In addition to ensuring the public accessibility of follow- up data from continuing trials, greater transparency is necessary into the ongoing deliberations and thinking of regu-lators who are currently evaluating applications from sponsors seeking to move from emergency use authorisations to actual approval or licensure.

Other regulatory documents produced by regulators that can provide greater insight into trials and the evidence development programme include scientific review memos and public assess-ment reports. In the USA, documents such as review memos and presentations presented to the federal advisory committee are also released. These are all invaluable, providing insight into regula-tory decision making (table 3). At around 50–150 pages, they can

Table 3 Availability of regulatory reviews and additional data for COVID-19 vaccines

Manufacturer Regulatory reviews and additional data

Pfizer USA FDA: main webpage, Emergency Use Authorisation review memorandum (57 pages), EUA review memorandum for 12–15 year olds (43 pages), advisory committee briefing documents (FDA, Pfizer)UK MHRA: main webpage, public assessment report (51 pages)AUS TGA: main webpage, public assessment report (42 pages)EU EMA: main webpage, public assessment report (140 pages), clinical information (6990 pages)Canada HC: main webpage, summary basis of decision (63 pages), clinical information (5910 pages)Japan PMDA: main webpage (English, Japanese), public assessment reportok (74 pages), clinical and non-clinical information (1239 pages)WHO: main webpage, background document to the WHO interim recommendations (44 pages)

Moderna USA FDA: main webpage, Emergency Use Authorisation review memorandum (61 pages), advisory committee meeting briefing documents (FDA, Moderna)UK MHRA: main webpage, public assessment report (7 pages)EU EMA: main webpage, public assessment report (169 pages), clinical information (6095 pages)Canada HC: main webpage, summary basis of decision (61 pages), clinical information (6095 pages)Japan PMDA: main webpage (English, Japanese), public assessment report (74 pages), clinical and non-clinical information (542 pages)WHO: main webpage, background document to the WHO interim recommendations (41 pages)

Oxford/AZ UK MHRA: main webpage, public assessment report (58 pages)AUS TGA: main webpage, public assessment report (49 pages)EU EMA: main webpage, public assessment report (181 pages)Canada HC: main webpage, summary basis of decision (66 pages)Japan PMDA: main webpage (English, Japanese), public assessment report (122 pages), clinical and non-clinical information (1134 pages)WHO: main webpage, background document to the WHO interim recommendations (56 pages)

Janssen USA FDA: main webpage, Emergency Use Authorisation review memorandum (69 pages), advisory committee meeting briefing documents (FDA, Janssen)UK MHRA: main webpage, public assessment report (11 pages)EU EMA: main webpage, public assessment report (218 pages)Canada HC: main webpage, summary basis of decision (60 pages)WHO: main webpage, background document to the WHO interim recommendations (54 pages)

Novavax None

Gamaleya Research Institute

None

Sinopharm WHO: main webpage, background document to the WHO interim recommendations (23 pages)

Sinovac WHO: main webpage, background document to the WHO interim recommendations (30 pages)


Regulatory agencies for each country.: USA FDA; UK MHRA; Canada HC; Japan PDMA; International/non- country entity WHO.

AUS, Australia; EMA, European Medicines Agency; EU, European Union; FDA, Food and Drug Administration; HC, Heath Canada; MHRA, Medicines and Healthcare products Regulatory Agency; PMDA, Pharmaceuticals and Medical Devices Agency; TGA, Therapeutic Goods Administration; USA, United States of America; WHO, World Health Organization.


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be substantially longer than journal articles but still one or two orders of magnitude shorter than clinical study reports, and repre-sent the regulators’ analyses of data, not the data itself. Therefore, they should be regarded as complementary to, not substitutes for, trial data.24

Real-time transparency

Transparency should begin as trials get underway, and not be left as a bureaucratic exercise to be conducted after results are announced and decisions are made. This should be the case for all trials, but especially COVID-19 vaccines given their global signif-icance.

Before trialists begin recruiting participants, there are already a variety of pre- study documents in place, and release of these documents would allow for broader awareness and scrutiny of the trials. Are the right endpoints being studied? Are the right populations being recruited? Do informed consent forms convey sufficient information about study purpose?25 The power of real- time release of trial protocols was on display last summer when some manufacturers—Pfizer, Moderna, Janssen and AstraZeneca (for its US trial)—released study protocols for their phase 3 trials.26 That transparency not only revealed the inadequacy of what had been disclosed about the studies’ primary endpoint in trial registry entries, but helped stimulate public discussion and debate about what primary endpoint was acceptable, including at the FDA’s advisory committee the following month—all while the trials were ongoing.19 27 28

Mechanisms to stimulate greater transparency

Although trade- offs will need to be weighed in the context of a global public emergency, there are several immediate steps that governments agencies, regulators, pharmaceutical companies and professional bodies can take to achieve greater transparency of COVID-19 vaccine trials. To start, government agencies and regu-lators can create infrastructure to support submission and deposits of protocols, informed consent forms, committee charters and other pre- study documents. This could be done by using existing resources such as ClinicalTrials. gov. Moreover, regulatory docu-ments, memos, and scientific reviews used to make decisions on vaccine approval can also be shared on (or linked from) the trial registry entry. Platforms for sharing individual participant data already exist and can be leveraged (eg, Vivli, Clin ical Stud yDat aRequest. com and YODA), reducing overall monetary cost associ-ated with publishing of trial data.

Drug sponsors and companies can likewise create a dedicated section of their website for pre- study documentation (as some have done). This should not cause an undue burden as such docu-ments are already written and shared with regulators, and they contain no identifying patient information. All that needs to occur is the act of publicly posting a copy. Additionally, sponsors can provide clear and updated statements regarding their timeline for access to electronic individual participant data.

Professional bodies and academic organisations can also play a large role in promoting transparency. Public statements that convey the unacceptability of promises to begin sharing months and years from now, despite vaccine rollout, would help. More powerfully, professionals could pledge not to endorse new thera-peutic agents until full access to data is provided. Doing so would send a strong message that transparency is not a ‘nice to have,’ but a fundamental component of any intervention that purports to be based on science.29 These mechanisms and levers can serve as initial starting points to create greater transparency. Longer- term

solutions to advance data transparency may require further changes in policy and law.

ConclusionAlthough progress has been made over the past decades in clin-ical trial transparency, and there are some successes for COVID-19 vaccines, there is still much room for improvement. The lack of adequate transparency about COVID-19 vaccine trials and their regulation cannot be dismissed as unfortunate, stubborn prob-lems emblematic of the present culture in biomedicine. In a time of increasing public scrutiny, transparency of regulatory decision making leading to the approval of drug treatments and vaccines for COVID-19 is important to ensure patient and stakeholder trust. It is a scientific, moral and ethical imperative that access to complete trial data of these global public health interventions is urgently granted to patients, researchers and other key stake-holders.

Twitter Anisa Rowhani- Farid @AnisaFarid and Peter Doshi @RIATinitiative

Contributors ST and PD conceptualised the article and ST wrote the first draft. AR- F and KH led the data extraction and analysis. All authors (ST, AR- F, KH, TJ, PD) were involved in reviewing and editing the final manuscript.

Funding The Laura and John Arnold Foundation funds the RIAT Support Center, which supports the salaries of ST, AR- F, KH, TJ and PD.

Disclaimer The contents are those of the authors and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS, The University of Maryland, or the US Government.

Competing interests KH was supported by the Food and Drug Administration (FDA) of the US Department of Health and Human Services (HHS) as part of a financial assistance award U01FD005946, unrelated to this manuscript, totaling US$5000 with 100% funded by FDA/HHS. PD has received travel funds from the European Respiratory Society (2012) and Uppsala Monitoring Center (2018); grants from the FDA (through University of Maryland M- CERSI; 2020), Laura and John Arnold Foundation (2017–2022), American Association of Colleges of Pharmacy (2015), Patient- Centered Outcomes Research Institute (2014–2016), Cochrane Methods Innovations Fund (2016-2018) and UK National Institute for Health Research (2011–2014); was an unpaid IMEDS steering committee member at the Reagan- Udall Foundation for the FDA (2016–2020), and is an editor at The BMJ. The Laura and John Arnold Foundation funds the RIAT Support Center, which supports the salaries of ST, ARF, KH, TJ, and PD. TJ’s competing interests are online (https:// restoringtrials. org/ competing- interests- tom- jefferson/).

Patient consent for publication Not required.

Provenance and peer review Commissioned; externally peer reviewed.

This article is made freely available for use in accordance with BMJ’s website terms and conditions for the duration of the covid-19 pandemic or until otherwise determined by BMJ. You may use, download and print the article for any lawful, non- commercial purpose (including text and data mining) provided that all copyright notices and trade marks are retained.


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ORCID iDsSarah Tanveer http:// orcid. org/ 0000- 0002- 6408- 9855Anisa Rowhani- Farid http:// orcid. org/ 0000- 0003- 3637- 2423Tom Jefferson http:// orcid. org/ 0000- 0002- 4778- 2949Peter Doshi http:// orcid. org/ 0000- 0002- 7804- 4113

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16 Fonseca P. Brazil institute says CoronaVac efficacy above 50% but delays full results [Internet], 2020. Reuters. Available: https://www. reuters. com/ business/ healthcare- pharmaceuticals/ sinovacs- covid- 19- vaccine- over- 50- effective- brazil- tests- reports- newspaper- folha- 2020- 12- 23

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June 1, 2021 Electronic Submission Division of Dockets Management Food and Drug Administration Department of Health and Human Services 5630 Fishers Lane, Room 1061 Rockville, MD 20852

CITIZEN PETITION

This petition for administrative action is submitted on behalf of the undersigned petitioners (“Petitioners”) pursuant to 21 C.F.R. § 10.30 and related relevant provisions of the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act to request that the Commissioner of Food and Drugs (the “Commissioner”) require that the vaccine manufacturers provide the FDA with the data outlined in the “Actions Requested” section below before approval of any COVID-19 vaccine. The Food and Drug Administration (FDA) has granted Emergency Use Authorizations (EUAs) to three COVID-19 vaccines, enabling rapid, and widespread vaccine rollout across the United States. These EUAs do not have any built-in expiration date, and therefore vaccines can continue to be lawfully distributed under EUA even after a future date when a public health emergency no longer exists. Approximately five months have passed since the first EUAs were granted, and one vaccine manufacturer now seeks licensure (approval) and has submitted a Biologics License Application (BLA). Other manufacturers have indicated similar intentions, as well as intentions for EUAs for additional pediatric populations. We believe the FDA should not prematurely grant a license to any COVID-19 vaccine until all necessary efficacy and safety studies are completed and substantial evidence demonstrates the benefits of an individual COVID-19 vaccine product outweigh the harms for the indicated, recipient population. We are concerned that the premature licensure of a COVID-19 vaccine can seriously undermine public confidence in regulatory authorities, particularly if long-term safety issues were to emerge following licensure. In this petition, we outline efficacy and safety measures that must be met before serious consideration is given to granting a BLA of any COVID-19 vaccine. These measures include:

1. Completing at least 2 years of follow-up of participants originally enrolled in pivotal clinical trials, even if the trials were unblinded and now lack a placebo control. All vaccine manufacturer phase 3 trials were already designed with this planned duration.

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2. Ensuring, prior to including in the list of populations for which a vaccine is approved, that there is substantial evidence of clinical effectiveness that outweighs harms in special populations such as: infants, children, and adolescents; those with past SARS-CoV-2 infection; immunocompromised; pregnant women; nursing women; frail older adults; and individuals with cancer, autoimmune disorders, and hematological conditions.

3. Requiring thorough safety assessment of spike proteins being produced in-situ by the body tissues following vaccine administration, and spike proteins’ full biodistribution, pharmacokinetics, and tissue specific toxicity.

4. Completion of vaccine biodistribution studies from administration site and safety implications of mRNA translation in distant tissues.

5. Thorough investigation of all severe adverse reactions reported following COVID-19 vaccination, such as deaths, reported in the United States and global pharmacovigilance systems.

6. Assessment of safety in individuals receiving more than two doses. 7. Inclusion of gene delivery and therapy experts in the Vaccines and Related Biological

Products Advisory Committee (VRBPAC), in recognition of the fact that the novel COVID vaccines work on the premise of gene delivery, in contrast to conventional vaccines.

8. Enforcing stringent conflict of interest requirements to ensure individuals involved in data analysis and BLA-related decision making processes have no conflict of interests with vaccine manufacturers.

A COVID-19 vaccine BLA should be approved when—and only when—substantial evidence demonstrates the benefits of a specific product outweigh the harms for the indicated, recipient population. This means that the following are invalid reasons to approve a COVID-19 vaccine:

● To ensure vaccines are accessible after the public health emergency has ended. COVID-19 vaccines granted an emergency use authorization (EUA) can be lawfully used after the expiry of the SARS-CoV-2 public health emergency declaration. (This is made clear by the many products for Ebola and Zika viruses which still have active EUAs.1)

● To ensure adequate access to vaccines across the population. A BLA is not necessary to

assure access to COVID-19 vaccines. Unlike normal licensing, in which widespread use of a drug or vaccine follows approval, EUAs for COVID-19 vaccines have enabled, and continue to enable, their widespread use. Ensuring access to vaccines is irrelevant to the considerations for issuance of a BLA because broad access to COVID-19 vaccines has already been accomplished.

● To enable vaccine mandates. Consideration of vaccine mandates is outside of FDA’s purview. Furthermore, a mandate should only be considered once the evidentiary conditions are met for a BLA (demonstrating that benefits outweigh harms).

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● To bolster public confidence. Like mandates, approving a medical product in order to bolster public confidence is backward logic and is outside the FDA’s purview. Approving before substantial evidence that population-based evidence of clinical effectiveness is superior to harms may contribute to public wariness and hesitancy, not only about COVID-19 vaccines, but other vaccines and public health authorities more broadly. An approval may bolster public confidence, but it is not a valid reason to approve.

Regardless of any legitimacy of each of the above reasons, none provides grounds to approve a COVID-19 vaccine. The widespread use of a COVID-19 vaccine under EUA, particularly for a limited amount of time, also is not a valid reason to approve a product. Even if vaccine recipients are followed up within observational studies, such studies may have important design biases and flaws, and their conclusions, especially concerning clinical effectiveness outcomes, may not be reliable. Premature FDA approval of any COVID-19 vaccine could negatively impact the health and safety of US residents, with global ramifications considering the international importance of FDA decisions. It also could set a precedent of lowered standards for future vaccine approvals. For these reasons and due to the compelling need to ensure the safety and efficacy of any COVID-19 vaccine licensed by the FDA and to allow Petitioners the opportunity to seek emergency judicial relief should the instant Petition be denied, it is respectfully requested that FDA act on the instant Petition by June 11, 2021. I. ACTIONS REQUESTED Petitioners request that the FDA, prior to granting any license for a COVID-19 vaccine:

1. Confirm, in revised Guidance, that the FDA expects a minimum of 2 years of follow-up of participants enrolled in pivotal clinical trials, even if trials are unblinded and lack a placebo control.

2. Require data demonstrating substantial evidence of clinical effectiveness that outweighs

harms, in all special populations, as a condition of consideration of including these populations among the indicated populations. Special populations include: infants, children, and adolescents; those with past SARS-CoV-2 infection; immunosuppressed individuals; those with history of or current cancer; individuals with hematological disorders or autoimmune diseases; pregnant or nursing women; and frail older adults.

3. Require data on the safety and pharmacokinetic profiles of the spike protein.

4. Require data from biodistribution studies investigating the actual COVID-19 vaccines.

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5. Require data from pharmacovigilance systems in the US and globally documenting athorough investigation of serious adverse events, carried out by independent, impartialindividuals.

6. Clarify in revised Guidance that safety data from individuals receiving more than 2vaccine doses must be submitted.

7. Ensure the inclusion of experts in gene therapy in the VRBPAC.

8. Ensure that the analysis of data and decisions regarding any COVID-19 vaccine BLAapplication are informed by experts with no financial or research relationships with anyvaccine manufacturers within the last 36 months, both within FDA and amongst thecomposition of the VRBPAC.

II. STATEMENT OF GROUNDS

Here, in the order as above, we set out the rationale for each requested action.

1. Confirm, in revised Guidance, that the FDA expects a minimum of 2 years of follow-upof participants enrolled in pivotal clinical trials, even if trials are unblinded and lack aplacebo control. Rationale:

a. Requiring at least 2 years is consistent with the 2 year follow-up durationprospectively proposed by the manufacturers when they registered theirongoing phase 3 trials of COVID-19 vaccines (Moderna: NCT04470427, Pfizer:NCT04368728, Janssen: NCT04505722) and consistent with the June 2020 FDAguidance on COVID-19 vaccines which stated participants should be followed forCOVID-19 outcomes for “as long as feasible, ideally at least one to two years.”2

b. Important adverse event signals can be detected in clinical trials. This is truedespite enrolling tens of thousands of participants, which is still too few toassess rare adverse events. For example, a serious blood clot occurring in thephase 3 Janssen clinical trial led to an initial trial pause in October 2020.3

c. Two year follow-up from trials allows the detection of commonly experiencedlonger-term adverse effects that may not manifest until many months followingvaccination.

d. Two year follow-up from trials would also allow for more detailed assessment ofinfection, re-infection, infectiousness, and the monitoring of immune responseover time, among all vaccinated participants.

e. The quality of data collection in clinical trials can be expected to be superior topassive data collection systems like the Vaccine Adverse Event Reporting System(VAERS). Therefore, trials of at least 2 years duration provide a valuable chanceto develop a more complete understanding of the adverse event profile in thegeneral population as well as in specific groups, such as individuals of

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reproductive age, immunocompromised individuals, and different age groups, including adolescents and young children.

f. The quality of data on adverse events during an ongoing trial can be improved while the trial is ongoing (e.g., improving the range of types of adverse events that are systematically assessed), as and when evidence from other data sources (e.g., pre-clinical or pharmacovigilance) show any trends or indicate specific types of adverse events of special interest.

g. Finally, the expectation of at least 2 years of follow-up prior to BLA also carries the advantage of longer-term data collection from other available sources (e.g., MedWatch/VAERS, V-safe, Vaccine Safety Datalink, FDA-CMS, BEST & PRISM, VA Electronic Health Records & data warehouse, Department of Defense DMSS, and Genesis HealthCare (Brown University & NIH-National Institute of Aging), as well as other medical claims databases).

2. Require data demonstrating substantial evidence of clinical effectiveness that

outweighs harms, in all special populations, as a condition of consideration of including these populations among the indicated populations. Special populations include: infants, children, and adolescents; those with past SARS-CoV-2 infection; immunosuppressed individuals; those with history of or current cancer; individuals with hematological disorders or autoimmune diseases; pregnant or nursing women; and frail older adults. Rationale:

a. The efficacy and safety of medicines often differs amongst populations such as healthy young adults vs. older adults, men vs. women, or SARS-CoV-2 survivors vs. never-exposed individuals.

b. For example, the relative risks of SARS-CoV-2 infection, hospitalization, and death are considerably lower in infants, children, and adolescents in comparison to adults.4,5

c. For example, individuals who experienced past SARS-CoV-2 infection (which are now believed to be a significant minority of many subpopulations6) are likely to have immunity to subsequent infections for as long or longer than immunity conferred by vaccine,7–10 and may also be at heightened risk for adverse effects.11–14

d. The ongoing phase 3 trials of COVID-19 vaccines (Moderna: NCT04470427, Pfizer: NCT04368728, Janssen: NCT04505722) largely (or wholly) excluded the following important populations in which there is reason to believe the effects of the product may differ from the populations enrolled in the trial:

i. Infants, children, and adolescents ii. Those with past SARS-CoV-2 infection

iii. Those who are immunosuppressed iv. Those with history of or current cancer v. Those with hematological disorders

vi. Those with autoimmune diseases vii. Those who are pregnant or nursing

viii. Frail older adults (including those living in nursing homes)

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e. The question is not simply whether there is efficacy, but how much efficacy exists in these populations, what kind of efficacy (e.g. reduction in risk of symptomatic COVID-19 vs. reduction in risk of hospitalization or death), and do efficacy advantages outweigh potential harms in these populations.

f. Before these special populations can be considered for inclusion amongst the approved indicated populations, data demonstrating substantial evidence of clinical effectiveness that outweighs harms in these specific populations, are needed.

3. Require data on the safety and pharmacokinetic profiles of the spike protein.

Rationale: a. In-situ production of SARS-CoV-2 spike protein is the target mechanism of action

of all COVID-19 vaccines with an EUA at present. Therefore, the safety profile of spike protein itself (i.e., in the absence of virus) must be thoroughly understood in the range of populations on the indications list.

b. Recently, evidence of systemic circulation of spike protein or its components in subjects post-immunization was reported.15 All studies we are aware of to date raise concerns about the safety of spike protein,16–28 and the concentration of circulatory spikes was correlated to the disease severity in COVID-19 patients.29

c. Required studies must, at a minimum, address these concerns: i. Coagulopathy issues, including blood clots, hemorrhage,

thrombocytopenia, heart attack, and strokes. According to the VAERS, as of May 21, 2021, there have been a total of 1,222 reports of thrombocytopenia/low platelets; and 6,494 (112 in 0-24 year-olds) reports of blood clots/strokes.

ii. Reproductive issues, including menstrual irregularities, reduced fertility, miscarriages, and preterm births. According to VAERS, as of May 21, 2021, there were 511 reports of miscarriage and 522 reports of uterine hemorrhage (including 88 in women older than 50 years). The vaccines induce the generation of antibodies to attack spike protein, which are genetically similar to proteins produced by the placenta.30 To date, no vaccine sponsors have conducted immunologic studies of spike protein involvement with proteins involved in placental development.

iii. Carcinogenesis. There is preliminary and theoretical evidence that the spike protein may promote cancer.31,32 Considering the potential for annual booster vaccinations, COVID-19 vaccines should be treated similarly to medication taken for chronic conditions on a long term basis. Carcinogenic potential is important to characterize.

iv. Transmission of spike protein (or its fragments) from vaccinated individuals, such as through breast milk and associated risk in neonates and infants. According to the UK Medicines & Healthcare products Regulatory Agency, there are 921 reports of exposure via breast milk following AstraZeneca’s vaccine and 215 reports following Pfizer’s vaccine.

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v. Neurological disorders, including Guillain-Barré syndrome, acute disseminated encephalomyelitis, transverse myelitis, encephalitis, myelitis, encephalomyelitis, meningoencephalitis, meningitis, encephalopathy, demyelinating diseases, and multiple sclerosis.

vi. Cardiac issues, including myocardial infarction, myocarditis and pericarditis, among others. According to the VAERS, as of May 21, 2021, there have been a total of 1,598 reports of heart attacks (24 reported in 0-24 year-olds; 501 resulted in death).

vii. Autoimmune diseases, including thyroiditis and diabetes mellitus, immune thrombocytopenia, autoimmune hepatitis, primary biliary cholangitis, systemic sclerosis, autoimmune disease for skeletal muscles (myasthenia gravis, myositis such as polymyositis, dermatomyositis, or other inflammatory myopathies)

viii. Studies should be conducted in individuals of both sexes33 and all ages. We cannot assume that the effects of spike protein are the same across populations of all ages, sex, and across pre-existing conditions.

4. Require data from biodistribution studies investigating the actual COVID-19 vaccines.

Rationale: a. Data from the biodistribution studies submitted by Moderna and Pfizer suggests

that the vaccines distribute widely in the body, including to the liver, brain, heart, lung, adrenals, ovaries, and testes, among many other tissues.34,35 (See Tables 1a, 1b, and 2 below for studies R-[?]-0072 and 185350 submitted by Pfizer and study 5002121 submitted by Moderna.)

b. However these were not studies of the currently authorized products: Pfizer’s BNT162b2, Moderna’s mRNA-1273, or Janssen’s Ad26.COV2.S.34–36

c. Instead of presenting novel biodistribution studies of the COVID-19 vaccine formulations, sponsors presented substitute studies to FDA for an EUA during the pandemic.34–36

d. Therefore, novel biodistribution studies investigating the actual COVID-19 vaccines are necessary.

e. Biodistribution studies would be required for any small molecule pharmaceutical drug submitted for approval (i.e. New Drug Application), and should be conducted on the COVID-19 vaccines as well as these novel vaccines which work on the premise of gene delivery--very different to conventional vaccines.

f. Biodistribution studies help inform an understanding of vaccine transfection to various tissues (away from injection site) spurring various distant tissues to produce spike proteins and consequent autoimmune response against the body’s cells. These studies will therefore help enhance our understanding of the nature of potential short and long term adverse events. At this point in time, in which other data sources exist to characterize short term harms of COVID-19 vaccines with an EUA, the utility of biodistribution studies to characterize long term adverse effects and better understand potential mechanism(s) of action of short and long term harms, remains critically important.

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g. Necessary studies must, at a minimum, address these concerns related to biodistribution, as well as the effects of vaccines in the body:

i. The need to know basic pharmacokinetic parameters, including absorption, distribution, metabolism, and excretion (ADME).

ii. Effects of multiple doses. ADME may change depending on dose and cumulative dose and should be investigated. This is more important than usual as the whole purpose of all COVID-19 vaccines with an EUA at present is to change the body’s way of processing spike protein, and therefore repeated injections should result in different rates of clearance of spike protein from the blood, and different rates of immune attack on spike protein producing cells.

iii. The impact of body mass index (size of deltoid muscle) and vaccine distribution away from injection site, implications for dose estimation for lean or younger age groups or frail older adults.

iv. The duration of the studies must be sufficient to fully understand the complete distribution and elimination of the injected vaccine and its carrier and other constituents. For example, data from the substitute study submitted for Pfizer’s vaccine (see Tables 1a, 1b, and 2 below for studies R-[?]-0072 and 185350 submitted by Pfizer and study 5002121 submitted by Moderna) showed levels of drug product increasing at the 48 hour mark, but it is unknown what occurred after 48 hours as this was apparently the study cut off.37

v. Potential side effects (safety review) in those organs/tissues with a detectable proportion of injected vaccine (antigen or novel excipients) from the circulatory system.

5. Require data from pharmacovigilance systems in the US and globally documenting a

thorough investigation of serious adverse events, carried out by independent, impartial individuals. Rationale:

a. A major testament to the overall short-term safety of a medical product is the absence of serious adverse events (SAEs) when administered to millions. COVID-19 vaccines have now been administered to hundreds of millions of individuals, and it is vital that all reports of SAEs are thoroughly investigated to determine whether the vaccine played any role in the SAE.

b. The most serious of all SAEs is death, and a CDC webpage on VAERS discusses 4,863 reports of death after COVID-19 vaccination reported between December 14, 2020 and May 24, 2021.38 CDC states that:

i. “CDC follows up on any report of death to request additional information to learn more about what occurred and to determine whether the death was a result of the vaccine or was unrelated.”

ii. “CDC and FDA physicians review each case report of death as soon as notified and CDC requests medical records to further assess reports.”

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iii. “A review of available clinical information, including death certificates, autopsy, and medical records has not established a causal link to COVID-19 vaccines.”38

c. However, the FDA has stated that VAERS staff do not contact family members to learn more about the deaths. It stated: “Because the VAERS system is not designed to determine causality of adverse events, there is not a mechanism to follow-up with families for additional details. The determination of the cause of death is done by the certifying official who completes the death certificate or the pathologist who conducts the autopsy.”39

d. Regulators in other countries have conducted detailed case investigations (e.g. Norway’s investigation of 100 deaths amongst frail elderly following COVID-19 vaccination40,41).

e. FDA must require evidence of a thorough investigation into deaths and other SAEs—investigations that include contacting families to obtain a full medical history and personal accounts (in the case of deaths) and those who experienced the adverse event (in the case of other SAEs). Event adjudication, as done on data safety monitoring boards, must be in place in order to carry out detailed case investigations, and must be carried out by independent, impartial individuals.

6. Clarify in revised Guidance that safety data from individuals receiving more than 2

vaccine doses must be submitted by vaccine manufacturers. Rationale: a. There is wide speculation that COVID-19 vaccines may become offered as annual

vaccines, much like influenza vaccines, and regulators have already released guidance to this effect.42

b. Some manufacturers, such as Pfizer and Moderna, have indicated that a third dose may be necessary within the first 12 months. Other manufacturers may present similar claims in the future.43

c. The safety profile of multiple doses, possibly more than 70 doses across an average lifetime, must be considered at the time of licensure. Phase 3 trial data make clear that the safety profile differs by dose (e.g. dose 2 of the Pfizer and Moderna vaccines induce more severe systemic adverse events than dose 1).44,45

d. Information on the types and severity of adverse events that emerge following the administration of additional doses is necessary to better characterize long term safety.

7. Ensure the inclusion of experts in gene therapy in the VRBPAC. Rationale:

a. The COVID-19 vaccines produced by Pfizer, Moderna, and Janssen (as well as AstraZeneca, CanSinoBio (China) and Gamaleya Research Institute (Russia)) are gene based vaccines. Their mechanism of action differs substantially from all other vaccines that have been used on populations globally, as these novel vaccines work on the premise of gene delivery, and may therefore be considered a type of gene therapy. These gene based vaccines involve entering the cell, where the overwhelming majority of critical body activities occur, and utilizing

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the host’s cells to produce spike protein. This is an entirely different mechanism than that utilized by traditional vaccines such as inactivated, attenuated, subunit or protein-based (that are not intended to invade cells). Therefore, there is a need to consider safety with the informed perspectives of those with expertise in gene therapies.

8. Ensure that the analysis of data and decisions regarding any COVID-19 vaccine BLA

application are informed by experts with no financial or research relationships with any vaccine manufacturers within the last 36 months, both within FDA and amongst the composition of the VRBPAC. Rationale:

a. The public interest weighs strongly in favor of the evaluation of data and all decision making to be performed by competent individuals with independence from vaccine manufacturers (institutions that stand to gain or lose from a BLA decision on a COVID-19 vaccine). Disclosure requirements should be at least as stringent, if not more, than what is expected for writing a manuscript in a medical journal—namely, disclosure of relationships within the last 36 months, as requested by the International Committee of Medical Journal Editors (ICMJE). Insisting on this level of disclosure, and transparency of the disclosures, can publicly demonstrate the independence of the FDA’s decision making process.46

Table 1a. Pfizer study report R-[?]-0072, biodistribution study submitted by Pfizer to Japanese regulator (PMDA).

Source: Japan PMDA (PDF page 15).37

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Table 1b. Pfizer study report 185350, biodistribution study submitted by Pfizer to Japanese regulator (PMDA).


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Table 2. Modern study report 5002121, biodistribution study submitted by Moderna to Japanese regulator (PMDA).

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III. ENVIRONMENT IMPACT The petitioners hereby state that the relief requested in this petition will have no environmental impact and therefore an environmental assessment is not required under 21 C.F.R. Sections 25.30 and 25.31. IV. ECONOMIC IMPACT Economic impact information will be submitted upon request of the commissioner. V. CERTIFICATION The undersigned certifies that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes

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representative data and information known to the petitioner which are unfavorable to the petition. Respectfully submitted, Linda Wastila, BSPharm, MSPH, PhD*†

Professor, Pharmaceutical Health Services Research University of Maryland School of Pharmacy 220 Arch Street, Baltimore, Maryland 21201, U.S.A. * Lead petitioner, will accept all correspondence.

† Dr. Wastila’s organizational affiliation is included for identification purposes only. Peter Doshi, PhD†

Associate Professor, Pharmaceutical Health Services Research University of Maryland School of Pharmacy Baltimore, Maryland, U.S.A. † Dr. Doshi’s organizational affiliation is included for identification purposes only. Hamid A. Merchant, BPharm, MPharm, PhD, RPh, CQP, PGCertHE, FHEA, SRPharmS†

Subject Leader in Pharmacy University of Huddersfield Huddersfield, United Kingdom † Dr. Merchant’s organizational affiliation is included for identification purposes only. Kim Witczak President/Co-Founder Woodymatters Minneapolis, Minnesota, U.S.A. Peter Aaby, MSc, DMSc†

Head of Bandim Health Project, Guinea-Bissau University of Southern Denmark Copenhagen, Denmark † Dr. Aaby’s organizational affiliation is included for identification purposes only.

Christine Stabell Benn, MD, PhD, DMSc† Professor of Global Health University of Southern Denmark Copenhagen, Denmark † Dr. Benn’s organizational affiliation is included for identification purposes only.

Florence T. Bourgeois MD, MPH† Associate Professor of Pediatrics Harvard Medical School Boston, Massachusetts, U.S.A. † Dr. Bourgeois’s organizational affiliation is included for identification purposes only.

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Anthony J Brookes, PhD†

Professor of Genetics University of Leicester Leicester, United Kingdom † Dr. Brookes’s organizational affiliation is included for identification purposes only. Byram W. Bridle, PhD† Associate Professor of Viral Immunology University of Guelph Ontario, Canada † Dr. Bridle’s organizational affiliation is included for identification purposes only. Peter Collignon AM, MB, BS(Hons), BSc(Med), FRACP, FRCPA, FASM†

Professor Australian National University Medical School Canberra, Australia † Dr. Collignon’s organizational affiliation is included for identification purposes only. Juan Erviti, PharmD, PhD†

Unit of Innovation and Organization Navarre Health Service, Spain Pamplona, Spain † Dr. Erviti’s organizational affiliation is included for identification purposes only. Peter C. Gøtzsche, Professor, DrMedSci, MD, MSc Director Institute for Scientific Freedom Copenhagen, Denmark

David Healy, MD FRCPsych† Professor of Psychiatry McMaster University Ontario, Canada † Dr. Healy’s organizational affiliation is included for identification purposes only. Iona Heath, CBE FRCGP†

Past president of the Royal College of General Practitioners London, United Kingdom † Dr. Heath’s former affiliation is included for identification purposes only. Matthew Herder, JSM LLM†

Director, Health Law Institute Dalhousie University Nova Scotia, Canada † Prof. Herder’s organizational affiliation is included for identification purposes only. Tom Jefferson, MD MRCGP FFPHM†

Senior Associate Tutor University of Oxford † Dr. Jefferson’s organizational affiliation is included for identification purposes only. Robert M. Kaplan, PhD† Distinguished Research Professor UCLA Fielding School of Public Health Los Angeles, California, U.S.A. † Dr. Kaplan’s organizational affiliation is included for identification purposes only.

Ulrich Keil, MD, PhD, FRCP (London)†

Professor Emeritus University of Muenster Muenster, Germany † Dr. Keil’s organizational affiliation is included for identification purposes only. Joseph A. Ladapo, MD, PhD Associate Professor of Medicine David Geffen School of Medicine at UCLA Los Angeles, California, U.S.A. † Dr. Ladapo’s organizational affiliation is included for identification purposes only. Donald W. Light, PhD†

Professor of Comparative Health Policy and Psychiatry Rowan University School of Osteopathic Medicine Glassboro, New Jersey, U.S.A. † Dr. Light’s organizational affiliation is included for identification purposes only. Peter A. McCullough, MD, MPH†

Professor of Medicine Texas A & M College of Medicine Dallas, Texas, U.S.A. † Dr. McCullough’s organizational affiliation is included for identification purposes only.

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Barbara Mintzes, BA, MSc, PhD†

Associate Professor, School of Pharmacy The University of Sydney Sydney, Australia † Dr. Mintzes’ organizational affiliation is included for identification purposes only. Huseyin Naci, MHS, PhD†

Associate Professor of Health Policy London School of Economics and Political Science London, United Kingdom † Dr. Naci’s organizational affiliation is included for identification purposes only.

Allyson M Pollock, MBChB, FRCPH, FRCP (Ed) FRCGP† Clinical Professor of Public Health Institute of Health and Society, Newcastle University Newcastle upon Tyne, United Kingdom † Dr. Pollock’s organizational affiliation is included for identification purposes only. Angela Spelsberg, MD, SM†

Comprehensive Cancer Center Aachen Aachen, Germany † Dr. Spelsberg’s organizational affiliation is included for identification purposes only.

Erick Turner, MD†

Associate Professor of Psychiatry Oregon Health & Science University Portland, Oregon, U.S.A. † Dr. Turner’s organizational affiliation is included for identification purposes only. Patrick Whelan, MD PhD†

Associate Clinical Professor of Pediatrics David Geffen School of Medicine at UCLA Los Angeles, California, U.S.A. † Dr. Whelan’s organizational affiliation is included for identification purposes only.

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33. Madla CM, Gavins FKH, Merchant H, Orlu M, Murdan S, Basit AW. Let’s Talk About Sex: Differences in Drug Therapy in Males and Females. Adv Drug Deliv Rev [Internet]. 2021 May 17; Available from: http://dx.doi.org/10.1016/j.addr.2021.05.014

34. European Medicines Agency. Assessment Report. Comirnaty (COVID-19 mRNA vaccine (nucleoside-modified)), EMA/707383/2020 Corr.1 [Internet]. 2021 Feb [cited 2021 Apr 13]. Available from: https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf#page=45

35. European Medicines Agency. Assessment Report. COVID-19 Vaccine Moderna (COVID-19 mRNA Vaccine (nucleoside-modified)), EMA/15689/2021 Corr.1 [Internet]. 2021 Mar [cited 2021 Apr 13]. Available from: https://www.ema.europa.eu/en/documents/assessment-report/covid-19-vaccine-moderna-epar-public-assessment-report_en.pdf#page=47

36. European Medicines Agency. Assessment Report. COVID-19 Vaccine Janssen, EMA/158424/2021 [Internet]. 2021 Mar [cited 2021 Apr 13]. Available from: https://www.ema.europa.eu/en/documents/assessment-report/covid-19-vaccine-janssen-epar-public-assessment-report_en.pdf#page=50

37. Pfizer. SARS-CoV- 2 mRNA Vaccine (BNT162, PF-07302048) 2.6.4 Yakubutsu dōtai shiken no gaiyō bun [summary of pharmacokinetic studies] [Internet]. 2021 [cited 2021 May 28]. Available from: https://www.pmda.go.jp/drugs/2021/P20210212001/672212000_30300AMX00231_I100_1.pdf#page=16

38. CDC. Selected adverse events reported after COVID-19 vaccination [Internet]. 2021 [cited 2021 May 28]. Available from: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html

39. Doshi P. FDA response to BMJ on reports of death after covid-19 vaccination [Internet]. 2021 [cited 2021 May 28]. Available from: https://www.bmj.com/content/372/bmj.n149/rr-25

40. Wyller TB, Kittang BR, Ranhoff AH, Harg P, Myrstad M. Nursing home deaths after COVID-19 vaccination. Tidsskr Nor Laegeforen [Internet]. 2021 May 20;141. Available from: http://dx.doi.org/10.4045/tidsskr.21.0383

41. Torjesen I. Covid-19: Pfizer-BioNTech vaccine is “likely” responsible for deaths of some elderly patients, Norwegian review finds. BMJ [Internet]. 2021 May 27 [cited 2021 May 28];373. Available from: https://www.bmj.com/content/373/bmj.n1372

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42. Food and Drug Administration. Coronavirus (COVID-19) update: FDA Issues Policies to guide medical product developers addressing virus variants [Internet]. 2021 [cited 2021 May 28]. Available from: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-policies-guide-medical-product-developers-addressing-virus

43. Owens C. Vaccine boosters could be necessary as soon as September [Internet]. Axios. 2021 [cited 2021 May 28]. Available from: https://www.axios.com/coronavirus-vaccines-boosters-pfizer-moderna-e8d6bed6-8238-4e52-9959-ca4c6a6e0d5a.html

44. Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med [Internet]. 2020 Dec 31;383(27):2603–15. Available from: http://dx.doi.org/10.1056/NEJMoa2034577

45. Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, et al. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med [Internet]. 2021 Feb 4;384(5):403–16. Available from: http://dx.doi.org/10.1056/NEJMoa2035389

46. Thacker PD. Covid-19: How independent were the US and British vaccine advisory committees? BMJ [Internet]. 2021 May 26;373:n1283. Available from: http://dx.doi.org/10.1136/bmj.n1283

47. Moderna. SARS-CoV- 2 mRNA Vaccine (Moderna) 2.6.4 Yakubutsu dōtai shiken no gaiyō bun [summary of pharmacokinetic studies] [Internet]. 2021 [cited 2021 May 29]. Available from: https://www.pmda.go.jp/drugs/2021/P20210519003/400256000_30300AMX00266_I100_1.pdf#page=7

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Why we petitioned the FDA to refrain from fully approving any covid-19vaccine this year

We are part of a group of clinicians, scientists, and patient advocates who have lodged a formal “Citizen

Petition” with the United States Food and Drug Administration (FDA), asking the agency to delay any

consideration of a “full approval” of a covid-19 vaccine. The message of our petition is “slow down and get

the science right—there is no legitimate reason to hurry to grant a license to a coronavirus vaccine.” We

believe the existing evidence base—both pre- and post-authorization—is simply not mature enough at this

point to adequately judge whether clinical benefits outweigh the risks in all populations.

The covid-19 vaccines in widespread use have emergency authorizations (EUA), not actual approvals, a

crucial regulatory distinction that reflects major differences in the level of regulatory scrutiny and certainty

about the risk-benefit balance.

Our petition doesn’t argue that risks outweigh benefits—or that benefits outweigh risks. Rather, we focus on

methods and processes, outlining the many remaining unknowns about safety and effectiveness—and

suggest the kinds of studies needed to address the open questions.

If the FDA listens to us, they won’t give serious consideration to approving a covid-19 vaccine until 2022. Our

first request is that the FDA require manufacturers to submit data from completed Phase III trials—not

interim results. Trials by vaccine manufacturers were designed to follow participants for two years, and

should be completed before they are evaluated for full approval, even if they are now unblinded and lack

placebo groups. These Phase III trials are not simply efficacy studies; they also are necessary and important

safety studies (as the study titles say), and all collected data remain invaluable.

We also call on FDA to require a more thorough assessment of spike proteins produced in-situ by the body

following vaccination—including studies on their full biodistribution, pharmacokinetics, and tissue-specific

toxicities. We ask the FDA to demand manufacturers complete proper biodistribution studies that would be

expected of any new drug and request additional studies to better understand the implications of mRNA

translation in distant tissues. We call on data demonstrating a thorough investigation of all serious adverse

events reported to pharmacovigilance systems, carried out by independent, impartial individuals, and for

safety data from individuals receiving more than two vaccine doses, in consideration of plans for future

booster shots. We ask the FDA to request necessary studies in specific populations, including those

previously infected with SARS-CoV-2, pediatric subjects, and those with immunological or other underlying

medical complexities. Given the nature of the novel vaccine platforms, our petition asks for experts in gene

therapy to be included among the external committee advising the FDA.

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These are several of our major requests. The petition has been signed by a group of 27 clinicians, researchers,

and consumer advocates with diverse experiences and thoughts about the pandemic. We all agree that there

remain many open, unanswered questions surrounding the efficacy and safety of covid-19 vaccines that

must be answered before the FDA gives serious consideration to granting full approval.

These are the reasons why we lodged our petition. There is no need to rush approval to help stop the

pandemic because the vaccines already have Emergency Use Authorization. Yet a rushed process is the very

possibility that now confronts us. In the past month, Pfizer and Moderna submitted formal applications for

“full approval.”

Covid-19 vaccines are already fully accessible to all Americans who want one. EUAs have enabled their

widespread use, and can remain in place even after the expiry of the SARS-CoV-2 public health emergency

declaration, as is the case for various Zika products. Even without full approval, covid-19 vaccines will remain

available for all who want them under EUA.

Some surveys suggest that vaccine hesitancy in the United States is due, in part, to lack of full FDA approval.

While approval might lead to increased public confidence in covid-19 vaccines, as well as provide legal

support for employer-instituted vaccine mandates, to approve a medical product for these reasons is outside

FDA’s regulatory purview. Approval decisions must be driven by the safety and efficacy data. The potential

unintended consequences of a rushed approval may contribute to growing mistrust of the US public health

and regulatory institutions.

Finally, regarding the elephant in the room: publicly raising any element of hesitation about covid-19

vaccines will be seen by some as irresponsible, stoking unfounded fears in the public’s mind and contributing

to the “vaccine hesitancy” problem trumpeted every day. But the alternatives—privately raising concerns or

simply remaining silent—are arguably more detrimental to public trust in the long run. Staying silent is not

the responsible option. And the implications of only privately raising concerns to regulatory bodies are

murky—most would probably not be acted upon, and if they were, it would promulgate the baggage of

insufficient accountability and transparency in decision making.

To us, the Citizen Petition seemed the most responsible approach: voice our concerns in our own words, in a

professional and transparent manner, through a formal mechanism that can promote accountability in

regulatory decision making.

Approving a covid-19 vaccine now risks setting a precedent of lowered standards for future vaccine

approvals. The “FDA approved” seal must represent a high bar—and premature licensure of a covid-19

vaccine could seriously damage public confidence in regulatory authorities, particularly if long-term safety

issues were to emerge following licensure. Keeping covid-19 vaccines under EUA regulations would also

encourage vaccine manufacturers to continue investing resources in completing the necessary safety and

efficacy studies for a potential FDA consideration of full licensure in the future.

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For each covid-19 vaccine, the benefits may ultimately outweigh the harms. Or not. Or we may end up in a

more nuanced position, finding that benefits outweigh harms for some populations, but not others. Only

time—and better evidence—will tell. And so it is vital we allow the scientific process the time required to

gather and assess the evidence to be confident in the decisions we ultimately have to make.

Our citizen petition is filed under Docket ID FDA-2021-P-0786 on regulations.gov. Anybody can comment on

the petition, or read others’ comments, including the FDA’s official reply once it arrives.

See also:

Covid-19 vaccines: In the rush for regulatory approval, do we need more data?

US college covid-19 vaccine mandates don’t consider immunity or pregnancy, and may run foul of the

law

LLinda Wastilainda Wastila is Professor and Parke-Davis Endowed Chair of Geriatric Pharmacotherapy at the University of

Maryland Baltimore School of Pharmacy. She has conducted policy and epidemiological research focusing on

intended and unintended outcomes of clinical and policy interventions involving medications and their

safety over the past 30 years.

PPeter Doshieter Doshi is an associate professor of pharmaceutical health services research at University of Maryland

Baltimore School of Pharmacy and senior editor at The BMJ. He has been calling for greater independence

and transparency in covid-19 vaccine related decision making.

HHamid Merchantamid Merchant is a subject lead in pharmacy at The University of Huddersfield and has experience in

pharmaceutical research and development both from industry and academia. His clinical knowledge and

expertise in pharmaceutical formulation helps in understanding the clinical and therapeutic principles

underpinning drug delivery and the science of dosage-form design.

KKim WitczakiKKim Witczak is a global drug safety advocate with over 25 years of advertising and marketing experience. She

co-founded Woodymatters, an organization started after the death of her husband due to undisclosed side

effects of antidepressants. Kim is currently Consumer Representative on the FDA Psychopharmacologic

Drugs Advisory Committee.

CCompeting interests: ompeting interests: PD has received travel funds from the European Respiratory Society (2012) and Uppsala

Monitoring Center (2018); grants from the FDA (through University of Maryland M-CERSI; 2020), Laura and

John Arnold Foundation (2017-22), American Association of Colleges of Pharmacy (2015), Patient-Centered

Outcomes Research Institute (2014-16), Cochrane Methods Innovations Fund (2016-18), and UK National

Institute for Health Research (2011-14); was an unpaid IMEDS steering committee member at the Reagan-

Udall Foundation for the FDA (2016-20), and is an editor at The BMJ. None further declared.

The views and opinions expressed here are those of the authors and do not necessarily reflect official policy

or position of the University of Maryland or the University of Huddersfield.

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Editor’s note 30 July 2021: The links in this article have been updated to reflect the re-filing of this petition

under the group name Coalition Advocating for Adequately Licensed Medicines (CAALM), which has been

assigned a new docket number (FDA-2021-P-0786).

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Does the FDA think these data justify the first full approval of a covid-19vaccine?

The FDA should demand adequate, controlled studies with long term follow up, and make data publicly

available, before granting full approval to covid-19 vaccines, says Peter Doshi

On 28 July 2021, Pfizer and BioNTech posted updated results for their ongoing phase 3 covid-19 vaccine trial.

The preprint came almost a year to the day after the historical trial commenced, and nearly four months

since the companies announced vaccine efficacy estimates “up to six months.”

But you won’t find 10 month follow-up data here. While the preprint is new, the results it contains aren’t

particularly up to date. In fact, the paper is based on the same data cut-off date (13 March 2021) as the 1 April

press release, and its topline efficacy result is identical: 91.3% (95% CI 89.0 to 93.2) vaccine efficacy against

symptomatic covid-19 through “up to six months of follow-up.”

The 20 page preprint matters because it represents the most detailed public account of the pivotal trial data

Pfizer submitted in pursuit of the world’s first “full approval” of a coronavirus vaccine from the Food and Drug

Administration. It deserves careful scrutiny.

The elephant named “waning immunity”

Since late last year, we’ve heard that Pfizer and Moderna’s vaccines are “95% effective” with even greater

efficacy against severe disease (“100% effective,” Moderna said).

Whatever one thinks about the “95% effective” claims (my thoughts are here), even the most enthusiastic

commentators have acknowledged that measuring vaccine efficacy two months after dosing says little about

just how long vaccine-induced immunity will last. “We’re going to be looking very intently at the durability of

protection,” Pfizer senior vice president William Gruber, an author on the recent preprint, told the FDA’s

advisory committee last December.

The concern, of course, was decreased efficacy over time. “Waning immunity” is a known problem for

influenza vaccines, with some studies showing near zero effectiveness after just three months, meaning a

vaccine taken early may ultimately provide no protection by the time “flu season” arrives some months later.

If vaccine efficacy wanes over time, the crucial question becomes what level of effectiveness will the vaccine

provide when a person is actually exposed to the virus? Unlike covid vaccines, influenza vaccine performance

has always been judged over a full season, not a couple months.

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And so the recent reports from Israel’s Ministry of Health caught my eye. In early July, they reported that

efficacy against infection and symptomatic disease “fell to 64%.” By late July it had fallen to 39% where Delta

is the dominant strain. This is very low. For context, the FDA’s expectation is of “at least 50%” efficacy for any

approvable vaccine.

Now Israel, which almost exclusively used Pfizer vaccine, has begun administering a third “booster” dose to

all adults over 40. And starting 20 September 2021, the US plans to follow suit for all “fully vaccinated” adults

eight months past their second dose.

Delta may not be responsible

Enter Pfizer’s preprint. As an RCT reporting “up to six months of follow-up,” it is notable that evidence of

waning immunity was already visible in the data by the 13 March 2021 data cut-off.

“From its peak post-dose 2,” the study authors write, “observed VE [vaccine efficacy] declined.” From 96% to

90% (from two months to <4 months), then to 84% (95% CI 75 to 90) “from four months to the data cut-off,”

which, by my calculation (see footnote at the end of the piece), was about one month later.

But although this additional information was available to Pfizer in April, it was not published until the end of

July.

And it’s hard to imagine how the Delta variant could play a real role here, for 77% of trial participants were

from the United States, where Delta was not established until months after data cut-off.

Waning efficacy has the potential to be far more than a minor inconvenience; it can dramatically change the

risk-benefit calculus. And whatever its cause—intrinsic properties of the vaccine, the circulation of new

variants, some combination of the two, or something else—the bottom line is that vaccines need to be

effective.

Until new clinical trials demonstrate that boosters increase efficacy above 50%, without increasing serious

adverse events, it is unclear whether the 2-dose series would even meet the FDA’s approval standard at six or

nine months.

The “six month” preprint based on the 7% of trial participants who remained blinded at six months

The final efficacy timepoint reported in Pfizer’s preprint is “from four months to the data cut-off.” The

confidence interval here is wider than earlier time points because only half of trial participants (53%) made it

to the four month mark, and mean follow-up is around 4.4 months (see footnote).

This all happened because starting last December, Pfizer allowed all trial participants to be formally

unblinded, and placebo recipients to get vaccinated. By 13 March 2021 (data cut-off), 93% of trial participants

(41,128 of 44,060; Fig 1) were unblinded, officially entering “open-label followup.” (Ditto for Moderna: by mid

April, 98% of placebo recipients had been vaccinated.)

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Despite the reference to “six month safety and efficacy” in the preprint’s title, the paper only reports on

vaccine efficacy “up to six months,” but not from six months. This is not semantics, as it turns out only 7% of

trial participants actually reached six months of blinded follow-up (“8% of BNT162b2 recipients and 6% of

placebo recipients had 6 months follow-up post-dose 2.”) So despite this preprint appearing a year after the

trial began, it provides no data on vaccine efficacy past six months, which is the period Israel says vaccine

efficacy has dropped to 39%.

It is hard to imagine that the <10% of trial participants who remained blinded at six months (which

presumably further dwindled after 13 March 2021) could constitute a reliable or valid sample to produce

further findings. And the preprint does not report any demographic comparisons to justify future analyses.

Severe disease

With the US awash in news about rising cases of the Delta variant, including among the “fully vaccinated,” the

vaccine’s efficacy profile is in question. But some medical commentators are delivering an upbeat message.

Former FDA commissioner Scott Gottlieb, who is on Pfizer’s board, said: “Remember, the original premise

behind these vaccines were [sic] that they would substantially reduce the risk of death and severe disease

and hospitalization. And that was the data that came out of the initial clinical trials.”

Yet, the trials were not designed to study severe disease. In the data that supported Pfizer’s EUA, the

company itself characterized the “severe covid-19” endpoint results as “preliminary evidence.” Hospital

admission numbers were not reported, and zero covid-19 deaths occurred.

In the preprint, high efficacy against “severe covid-19” is reported based on all follow-up time (one event in

the vaccinated group vs 30 in placebo), but the number of hospital admissions is not reported so we don’t

know which, if any, of these patients were ill enough to require hospital treatment. (In Moderna’s trial, data

last year showed that 21 of 30 “severe covid-19” cases were not admitted to hospital; Table S14).

And on preventing death from covid-19, there are too few data to draw conclusions—a total of three covid-

19 related deaths (one on vaccine, two on placebo). There were 29 total deaths during blinded follow-up (15

in the vaccine arm; 14 in placebo).

The crucial question, however, is whether the waning efficacy seen in the primary endpoint data also applies

to the vaccine’s efficacy against severe disease. Unfortunately, Pfizer’s new preprint does not report the

results in a way that allows for evaluating this question.

Approval imminent without data transparency, or even an advisory committee meeting?

Last December, with limited data, the FDA granted Pfizer’s vaccine an EUA, enabling access to all Americans

who wanted one. It sent a clear message that the FDA could both address the enormous demand for vaccines

without compromising on the science. A “full approval” could remain a high bar.

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But here we are, with FDA reportedly on the verge of granting a marketing license 13 months into the still

ongoing, two year pivotal trial, with no reported data past 13 March 2021, unclear efficacy after six months

due to unblinding, evidence of waning protection irrespective of the Delta variant, and limited reporting of

safety data. (The preprint reports “decreased appetite, lethargy, asthenia, malaise, night sweats, and

hyperhidrosis were new adverse events attributable to BNT162b2 not previously identified in earlier reports,”

but provides no data tables showing the frequency of these, or other, adverse events.)

It’s not helping matters that FDA now says it won’t convene its advisory committee to discuss the data ahead

of approving Pfizer’s vaccine. (Last August, to address vaccine hesitancy, the agency had “committed to use

an advisory committee composed of independent experts to ensure deliberations about authorization or

licensure are transparent for the public.”)

Prior to the preprint, my view, along with a group of around 30 clinicians, scientists, and patient advocates,

was that there were simply too many open questions about all covid-19 vaccines to support approving any

this year. The preprint has, unfortunately, addressed very few of those open questions, and has raised some

new ones.

I reiterate our call: “slow down and get the science right—there is no legitimate reason to hurry to grant a

license to a coronavirus vaccine.”

FDA should be demanding that the companies complete the two year follow-up, as originally planned (even

without a placebo group, much can still be learned about safety). They should demand adequate, controlled

studies using patient outcomes in the now substantial population of people who have recovered from covid.

And regulators should bolster public trust by helping ensure that everyone can access the underlying data.

PPeter Doshieter Doshi, senior editor, The BMJ.

CCompeting interests: ompeting interests: I helped organize the Coalition Advocating for Adequately Licensed Medicines (CAALM),

which has formally petitioned the FDA to refrain from fully approving any covid-19 vaccine this year (docket

FDA-2021-P-0786). A full list of competing interests is available here. The views and opinions expressed here

are mine and do not necessarily reflect official policy or the position of the University of Maryland.

Provenance: rPProvenance: commissioned; externally peer-reviewed.

FFootnote: FFootnote: Calculations in this article are as follows. “About 1 month” past month 4 is based on the final row of

Fig 2 in the preprint: 1030/12670*12 = 0.98 months (vaccine group) and 895/11802*12 = 0.91 months

(placebo group). “53%” is based on Fig 2: (12670+11802)/(23040+23037). “4.4 months” is based on the

average of 8412/22505*12 = 4.5 (vaccine) and 8124/22434*12 = 4.3 (placebo) in Fig 2.

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BMJ Opinion provides comment and opinion written by The BMJ's international community of readers,

authors, and editors.

We welcome submissions for consideration. Your article should be clear, compelling, and appeal to our

international readership of doctors and other health professionals. The best pieces make a single topical

point. They are well argued with new insights.

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Contact usWebsite terms & conditionsPrivacy policyRevenue sourcesHomeTop

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Exhibit 1

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P PPRESIDENT BIDEN'S COVID-19 ACTION PLAN

P resident Biden is implementing a six-pronged, comprehensive national strategy that

employs the same science-based approach that was used to successfully combat

previous variants of COVID-19 earlier this year. This plan will ensure that we are

using every available tool to combat COVID-19 and save even more lives in the months ahead,

while also keeping schools open and safe, and protecting our economy from lockdowns and

damage.

Vaccinating the

Unvaccinated

Further Protecting

the Vaccinated

Keeping Schools

Safely Open

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Vaccinating the Unvaccinated

Since January, the Administration has taken actions to make vaccination conveniently available

to all. COVID vaccines have been available to every individual age 16 and older since April 19th

and to those age 12 and older since May. The Administration took steps to make vaccinesavailable at over 80,000 locations nationwide, worked with pharmacies to offer walk-inappointments, and put out a call to action to businesses and organizations across the nation.

The President announced vaccination requirements for the federal government in July andcalled on the private sector to do more to encourage vaccination as well. Since that time,employers, schools, nursing homes, restaurants, hospitals, and cities in all 50 states haveannounced new vaccination requirements. Since July, the share of job postings that requirevaccination are up 90%. And we know these requirements work. At the beginning of August,when Tyson Foods announced its requirement—only 45% of its workforce had gotten a shot.

Increasing Testing &

Requiring Masking

Protecting Our

Economic Recovery

Improving Care for

those with COVID-19

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Today, it stands at 72%, meaning half of Tyson’s unvaccinated workers have now gotten a shot

—well ahead of the company’s November 1st deadline. After United Airlines announced itsvaccination requirement, more than half of its unvaccinated employees went out and gotvaccinated with weeks left to go before the deadline. In Washington State, the weeklyvaccination rate jumped 34% after the Governor announced requirements for state workers.

All told, these efforts—and countless other Administration initiatives and policies—haveresulted in over 175 million fully vaccinated Americans. But there are still nearly 80 millionAmericans eligible to be vaccinated who have not yet gotten their first shot.

The President’s plan will reduce the number of unvaccinated Americans by using regulatorypowers and other actions to substantially increase the number of Americans covered byvaccination requirements—these requirements will become dominant in the workplace. Inaddition, the plan will provide paid time off for vaccination for most workers in the country.

Requiring All Employers with 100+ Employees to Ensure their Workers areVaccinated or Tested Weekly

The Department of Labor’s Occupational Safety and Health Administration (OSHA) is developinga rule that will require all employers with 100 or more employees to ensure their workforce is fullyvaccinated or require any workers who remain unvaccinated to produce a negative test result onat least a weekly basis before coming to work. OSHA will issue an Emergency TemporaryStandard (ETS) to implement this requirement. This requirement will impact over 80 millionworkers in private sector businesses with 100+ employees.

Requiring Vaccinations for all Federal Workers and for Millions ofContractors that Do Business with the Federal Government

Building on the President’s announcement in July to strengthen safety requirements forunvaccinated federal workers, the President has signed an Executive Order to take those actionsa step further and require all federal executive branch workers to be vaccinated. The Presidentalso signed an Executive Order directing that this standard be extended to employees ofcontractors that do business with the federal government. As part of this effort, the Departmentof Defense, the Department of Veterans Affairs, the Indian Health Service, and the NationalInstitute of Health will complete implementation of their previously announced vaccinationrequirements that cover 2.5 million people.

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Further Protecting the Vaccinated

Requiring COVID- 19 Vaccinations for Over 17 Million Health Care Workersat Medicare and Medicaid Participating Hospitals and Other HealthCare Settings

The Centers for Medicare & Medicaid Services (CMS) is taking action to require COVID-19vaccinations for workers in most health care settings that receive Medicare or Medicaidreimbursement, including but not limited to hospitals, dialysis facilities, ambulatory surgicalsettings, and home health agencies. This action builds on the vaccination requirement for nursingfacilities recently announced by CMS, and will apply to nursing home staff as well as staff inhospitals and other CMS-regulated settings, including clinical staff, individuals providing servicesunder arrangements, volunteers, and staff who are not involved in direct patient, resident, orclient care. These requirements will apply to approximately 50,000 providers and cover amajority of health care workers across the country. Some facilities and states have begun toadopt hospital staff or health care sector vaccination mandates. This action will create aconsistent standard across the country, while giving patients assurance of the vaccination statusof those delivering care.

Calling on Large Entertainment Venues to Require Proof of Vaccination orTesting for Entry

The President’s plan calls on entertainment venues like sports arenas, large concert halls, andother venues where large groups of people gather to require that their patrons be vaccinated orshow a negative test for entry.

Requiring Employers to Provide Paid Time Off to Get Vaccinated

To continue efforts to ensure that no worker loses a dollar of pay because they get vaccinated,OSHA is developing a rule that will require employers with more than 100 employees to providepaid time off for the time it takes for workers to get vaccinated or to recover if they are under theweather post-vaccination. This requirement will be implemented through the ETS.

App000535


There are over 175 million fully vaccinated Americans who are largely protected from severeillness from COVID-19. While so-called “breakthrough infections” among this group dohappen, they remain the exception: In fact, recent data indicates there is only 1 confirmedpositive case per 5,000 fully vaccinated Americans per week.

But COVID-19 vaccination protection can be made even stronger. In August, the nation’s tophealth officials—Dr. Rochelle Walensky, CDC Director; Dr. Janet Woodcock, Acting FDACommissioner; Dr. Francis Collins, NIH Director; Dr. Anthony Fauci, Director of the NationalInstitute of Allergy and Infectious Diseases; Surgeon General Dr. Vivek Murthy; Dr. DavidKessler, COVID-19 Chief Science Officer; Dr. Rachel Levine, HHS Assistant Secretary forHealth; and Dr. Marcella Nunez-Smith, Chair of the COVID-19 Health Equity Task Force—released an initial plan for booster shots aimed at staying ahead of the virus. The plan releasedby our nation’s doctors allows for states, pharmacies, doctors’ offices, health insurers andothers to prepare for the administration of boosters. In the beginning weeks of the initialvaccination program in December 2020, the country lost precious time because we wereunprepared to administer shots. By planning now, we will be able to quickly get booster shotsinto the arms of eligible Americans once approved.

A booster promises to give Americans their highest level of protection yet. Three-shot vaccinesare common (Hepatitis B, Tetanus) and offer some of the most durable and robust protection.

Implementation of this plan depends on authorization of boosters by the Food and DrugAdministration (FDA) and recommendations by the CDC’s independent Advisory Committeeon Immunization Practices (ACIP). As soon as authorizations are given, the Administration

will be prepared to offer booster shots, starting the week of September 20th.

Keeping Schools Safely Open

Providing Easy Access to Booster Shots for All Eligible Americans

Ensuring Americans Know Where to Get a Booster

App000536


A top priority for the Biden Administration since Day One has been to reopen schools safelyand keep them open. The Administration has taken significant actions to get our kids back inthe classroom, including providing $130 billion in American Rescue Plan (ARP) funds to helpschools reopen, accelerate students’ academic growth, address inequities exacerbated by thepandemic, allow local school districts to implement CDC-recommended COVID-19 preventionstrategies, and support student and educators’ social, emotional, and mental health needs. Weknow how to keep students safe in schools by taking the right steps to prevent transmission—including getting all staff and eligible students vaccinated, implementing universal indoormasking, maintaining physical distancing, improving ventilation, and performing regularscreening testing for students and school staff. The President’s plan calls for additional actionsto ensure all schools consistently implement these science-based prevention strategiesrecommended by the CDC so that they can remain open for in-person learning and maintainthe health and safety of all students, staff, and families.

As we work to ensure our children are protected, we know that vaccination remains the bestline of defense against COVID-19. For those adolescents aged 12 and above who are eligible forvaccination, the most important step parents can take is to get them vaccinated. To date, overhalf of the nation’s adolescents have been vaccinated. For those too young to be vaccinated, it isespecially critical that they are surrounded by vaccinated people and mask in public indoorspaces, including schools. Studies released by the CDC found that the rate of hospitalizationfor children was nearly four times higher in states with the lowest vaccination rates comparedto states with high vaccination rates.

The FDA is undergoing a process now to evaluate a vaccine for children under the age of 12,and under the President’s plan, the Administration will do whatever it takes to support thoseefforts, while continuing to respect and defer to the scientific decision-making of the agency.

Requiring Staff in Head Start Programs, Department of Defense Schools,and Bureau of Indian Education-Operated Schools to be Vaccinated

Calling on All States to Adopt Vaccine Requirements for AllSchool Employees

App000537


Increasing Testing & Requiring Masking

It will take time for the newly vaccinated to get protection from the virus. As we continue tocombat COVID-19, testing is a key tool to identify infected individuals and prevent spread toothers. Likewise, masking can also help slow and contain the spread of the virus—and thecombination of increased vaccinations and masking will have a major impact on COVID-19transmission. President Biden’s plan takes new actions to increase the amount of testing—inyour own home, at pharmacies, and in your doctor’s office—and ensures that strong maskrequirements remain in place.

Providing Additional Funding to School Districts for Safe SchoolReopening, Including Backfilling Salaries and Other Funding Withheld byStates for Implementing COVID Safety Measures

Using the Department of Education’s Full Legal Authority to ProtectStudents’ Access to In-Person Instruction

Getting Students and School Staff Tested Regularly

Providing Every Resource to the FDA to Support Timely Review ofVaccines for Individuals Under the Age of 12

Mobilizing Industry to Expand Easy-to-Use Testing Production

Making At-Home Tests More Affordable

App000538


Protecting Our Economic Recovery

President Biden’s economic plan is working. Since Day One in office, the President has focusedon jumpstarting the economy and rebuilding it from the bottom up and the middle out.America is getting back to work, and workers and small businesses are seeing the results. SincePresident Biden took office, there has been historic job growth—more than 4 million jobscreated– the most in any President’s first six months, with 750,000 jobs created on average permonth over the last three months. Despite the challenges posed by the Delta variant, theeconomy created 235,000 jobs last month, and the unemployment rate fell to its lowest levelsince before the pandemic. The average number of new unemployment insurance claims hasbeen cut by more than half since President Biden took office, and more than 70 percent ofAmericans say that now is a good time to find a quality job, up from less than 30 percent thistime last year. The U.S. is the only major economy that has now exceeded its pre-pandemicgrowth projections, and independent forecasters believe America will this year reach thehighest levels of growth in decades.

COVID-19 impacts our economy, no doubt. But, the President’s plan will limit the damage andensure that the Delta variant cannot undo this progress. The policies outlined throughout thisplan will ensure that we do not return to lockdowns and shutdowns. Additionally, we will offernew support to small businesses as they continue to weather the surge caused by the Deltavariant. Supporting small businesses is critical to our economic growth, since they create two-

Sending Free Rapid, At-Home Tests to Food Banks and CommunityHealth Centers

Expanding Free, Pharmacy Testing

Continuing to Require Masking for Interstate Travel and Double Fines

Continue to Require Masking on Federal Property

App000539


thirds of net new jobs and employ nearly half of America’s private workforce. These reformsinclude:

Improving Care for those with COVID-19

As we work to reduce cases, hospitalizations, and deaths, we will maintain our focus ontreating people infected with COVID-19—and helping hard-hit health care systems in the mostimpacted areas. In early July, the Administration launched Surge Response Teams to helpstates experiencing case increases. Since then, the Administration has worked with 18 states,deploying nearly 1,000 personnel, including hundreds of EMTs, nurses and doctors on theground providing emergency medical care; surged hundreds of ventilators, ambulances andother critical assets to support strained health care systems; stood up dozens of new, freetesting sites; and assisted with local outbreak investigations.

As we continue to battle the Delta surge, the President’s plan will continue to send responseteams to states that request them and take additional actions to accelerate this work.

New Support for Small Businesses Impacted by COVID- 19

Streamlining the Paycheck Protection Program (PPP) LoanForgiveness Process

Launching the Community Navigator Program to Connect SmallBusinesses to the Help They Need

Increasing Support for COVID-Burdened Hospitals

App000540


President Biden’s plan to continue to combat COVID-19 this fall is comprehensive, science-based and relies on the power of the federal government working hand-in-hand with states,local communities, the private sector, and all Americans to put this pandemic behind us. Thestrategy outlined here is domestic focused. In the weeks ahead, the President will announceadditional steps to build on the progress the Administration has made to combat thispandemic globally. President Biden and his Administration will continue to use every toolnecessary to protect the American people from COVID-19.

Getting Life-Saving Monoclonal Antibody Treatment to Those WhoNeed It

Expanding the Pool of Health Care Professionals Providing Treatment byDeploying Federal Monoclonal Antibody Strike Teams

COVID-19

F COVID- 19 V N Y

Visit Vaccines.gov

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HEALTH

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Lies, mistruths and death

Protecting children

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A 'smoldering' future for US

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From: Enlow, Courtney D. (CIV)To: Aaron SiriCc: Elizabeth Brehm; Gabrielle PalmerSubject: RE: PHMPT v. FDA, No. 21-cv-1058 (N.D. Tex.)Date: Thursday, December 2, 2021 2:25:33 PM

Good afternoon Aaron, With regard to your first two questions, FDA will not be able to make those assessments at this time. In order for FDA to determine (1) the number of lines of spreadsheet data or (2) the total number ofpages for each line of the 87-page Index, FDA would need to perform a search by hand. In otherwords, an individual would have to click open each file listed on the 87-page Index to determine thesize of the file, and then manually record the file’s size. To perform that search for the number oflines of spreadsheet data, FDA estimates that it would take 1.5 days of a staff member’s time; toprovide the page counts for each entry in the Index, FDA estimates that it would take several days ofa staff member’s time. Due to the heavy burden such an effort would place on FDA’s limitedresources, it is not feasible for FDA to provide those estimates. With regard to your third question, are you asking whether there is any data in the Comirnatybiological product file that are not accounted for in the Index or the estimated 329,000+ pagecount? If so, the Cominarty biological product file also contains supplements, amendments, andproduct correspondence. FDA estimates that there are approximately 39,000 pages of records inthat category. In addition, there may be investigational new drug records that may be supportive ofthe BLA. Although FDA cannot provide a precise count at this time, FDA estimates that there wouldbe tens of thousands of additional pages in this category. These page counts are in addition to FDA’sestimate of 329,000+ pages (plus data files) in the original Cominarty BLA. If Plaintiff is amenable to the schedule I proposed yesterday, please let me know this week so thatwe can inform the Court. Thanks,Courtney Courtney EnlowTrial AttorneyU.S. Department of JusticeCivil Division, Federal Programs Branch1100 L Street, N.W., Room 12102Washington, D.C. 20005(202) [email protected]

From: Aaron Siri <[email protected]>

App000576


Sent: Wednesday, December 01, 2021 5:56 PMTo: Enlow, Courtney D. (CIV) <[email protected]>Cc: Elizabeth Brehm <[email protected]>; Gabrielle Palmer <[email protected]>Subject: [EXTERNAL] RE: PHMPT v. FDA, No. 21-cv-1058 (N.D. Tex.) Good afternoon Courtney, Thank you for the note. In order for me to have a meaningful conversation with my client, can youplease let me know (1) approximately how many lines of spreadsheet data would need to beprocessed, (2) the approximate total number of pages for each line item in the Index of ComirnatyBLA you previously provided (copy attached) and (3) what else is in the biological product file forComirnaty that is not reflected in the attached and is that included in the estimated 329,000 pagecount (and if not, how many pages does that consist of). Thank you,Aaron

From: Enlow, Courtney D. (CIV) <[email protected]> Sent: Wednesday, December 1, 2021 8:35 AMTo: Aaron Siri <[email protected]>; Gabrielle Palmer <[email protected]>Cc: Elizabeth Brehm <[email protected]>Subject: RE: PHMPT v. FDA, No. 21-cv-1058 (N.D. Tex.) Good morning Aaron, With regard to PHMPT v. FDA, No. 21-cv-1058 (N.D. Tex.), FDA has now had the opportunity toassess the number of responsive pages and to estimate processing times for additional portions ofPlaintiff’s priority list. In light of that assessment, FDA proposes that it produce the non-exemptportions of the following records by the below dates:

• By December 13, 2021, FDA plans to produce publicly releasable information from:

o Plaintiff’s priority item #1- CRF files for site 1055 (~2,030 pages);

o Completion of Plaintiff’s priority item #5-

Four additional .txt files that were listed on p. 10 of the index;

Four additional SAS files (not specifically listed on Plaintiff’s priority list, but

mentioned as something Plaintiff was interested in).

o Publicly releasable information from the following additional sections of the original

Comirnaty BLA:

Section 2.5 – Clinical Overview (~333 pages)

App000577


Section 2.7.3 – Summary of Clinical Efficacy (~182 pages)

Section 2.7.4 – Summary of Clinical Safety (~344 pages)

• By December 30, 2021, FDA plans to produce publicly releasable information from Plaintiff’s

priority item #2 – CRF files for site 1081 (~3,380 pages);


priority item #3 – CRF files for site 1096 (~2,937 pages); and


priority item #4 – CRF files for site 1128 (~3,452 pages).

Under this schedule, by the end of January 2022, FDA expects to have produced publicly releasableinformation from more than 12,000 pages of records and 10 unpaginated .txt or SAS data files. (Thispage and file count includes records produced to Plaintiff on November 17, 2021, and records thatwill be produced to Plaintiff later today.) FDA will also have completed production of seven of thefirst eight items on the priority list Plaintiff provided to FDA on November 4, 2021. After the January 31, 2022 production, FDA proposes to make one production at the end of eachsubsequent month totaling a minimum the non-exempt portions of 500 pages. (For purposes ofcalculating a “page count” of data records that are not paginated, FDA proposes considering twentylines of spreadsheet data the equivalent of one page. For example, production of a spreadsheetcontaining 2,000 lines of data would be counted the equivalent of a 100-page PDF record.) To theextent feasible, FDA plans to continue to prioritize records from Plaintiff’s priority list. Although FDAproposes a minimum rate of 500 pages a month, FDA will continue to produce records at a fasterrate where feasible. Please let me know if Plaintiff is amenable to this proposed schedule. If so, I propose that the partiesfile a joint status report setting out the agreed-upon schedule and requesting that the Court cancelthe hearing set for December 14 and the briefing deadlines. Thanks,Courtney Courtney EnlowTrial AttorneyU.S. Department of JusticeCivil Division, Federal Programs Branch1100 L Street, N.W., Room 12102Washington, D.C. 20005(202) [email protected]

App000578


From: Enlow, Courtney D. (CIV) Sent: Wednesday, November 17, 2021 1:40 PMTo: Aaron Siri <[email protected]>; Gabrielle Palmer <[email protected]>Cc: Elizabeth Brehm <[email protected]>Subject: PHMPT v. FDA, No. 21-cv-1058 (N.D. Tex.) Good afternoon Aaron and Gabrielle, I’ve attached correspondence from FDA and a release of records in PHMPT v. FDA, No. 21-cv-1058(N.D. Tex.). Kindly confirm receipt. Thanks,Courtney Courtney EnlowTrial AttorneyU.S. Department of JusticeCivil Division, Federal Programs Branch1100 L Street, N.W., Room 12102Washington, D.C. 20005(202) [email protected]

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Case 3:15-cv-00976-VAB Document 61 Filed 08/28/16 Page 1 of 6

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Exhibit A

Case 3:15-cv-00976-VAB Document 61-1 Filed 08/28/16 Page 1 of 4

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App000595


CautionAs of: December 7, 2021 4:43 AM Z

United States District Court for the Eastern District of Texas, Sherman Division

February 1, 2021, Decided; February 1, 2021, Filed

Civil Action No. 4:20-cv-447

2021 U.S. Dist. LEXIS 18199 *; 2021 WL 327510

BRIAN HUDDLESTON, v. FEDERAL BUREAU OF INVESTIGATION and UNITED STATES DEPARTMENT OF JUSTICE.

Stay granted by

requests, processing, scheduling order, Deadlines, exceptional circumstances, responding

[*1] For Brian Huddleston, Plaintiff: Ty Odell Clevenger, Ty Odell Clevenger, Attorney At Law, Brooklyn, NY.

For Federal Bureau of Investigation, U.S. Department of Justice, Defendants: Andrea Hedrick Parker, LEAD ATTORNEY, U S Attorney, Beaumont, TX.

AMOS L. MAZZANT, UNITED STATES DISTRICT JUDGE.

AMOS L. MAZZANT

Pending before the Court is Defendants' Motion to Stay

Scheduling Order Deadlines (Dkt. #10). After reviewing the Motion and the relevant pleadings, the Court finds the Motion should be granted in part and denied in part.

This case arises out of Plaintiff Brian Huddleston's FOIA requests against Defendants the Federal Bureau of Investigation ("FBI") and the Department of Justice ("DOJ") (Dkt. #1), which are pending before Defendants now (Dkt. #3, Exhibits 1-3). On October 22, 2020, the Court entered a scheduling order (Dkt. #9).

On December 16, 2020, Defendants filed their Motion to Stay Scheduling Order Deadlines (Dkt. #10), currently before the Court. On December 30, 2020, Plaintiff filed his response (Dkt. #11). On January 6, 2021, Defendants filed their reply (Dkt. #12). On January 7, 2021, Plaintiff filed his first sur-reply (Dkt. #13). On January [*2] 14, 2021, Defendants filed a sur-reply (Dkt. #15). And on January 20, 2021, Plaintiff filed his second sur-reply (Dkt. #18).

The authority to stay proceedings is "incidental to the power inherent in every court to control the disposition of the causes on its docket with economy of time and effort for itself, for counsel, and for litigants."

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of 5

. Because stays are "an 'intrusion into the ordinary processes of administration and judicial review,'"

(quoting

(per curiam)), they are "not a matter of right, even if irreparable injury might otherwise result,"

.Instead, stays are "an exercise of judicial discretion, and the 'party requesting a stay bears the burden of showing that the circumstances justify an exercise of that discretion.'"

(per curiam) (quoting );

(explaining that the responding agency bears the burden to demonstrate its due diligence in fulfilling its FOIA-related obligations).

The decision to stay proceedings is "left to the sound discretion of the district court, and it is the district court's responsibility to weigh the competing interests of the parties relating to the appropriateness of a stay."

(citing ). Since "FOIA imposes no limits on courts'

equitable [*3] powers in enforcing its terms," deciding whether to grant a stay is unaffected by FOIA.

(citing

.

Under FOIA, once the responding agency receives a records request, it must, among other things,

determine within 20 days (excepting Saturdays, Sundays, and legal public holidays) after the receipt of any such request whether to comply with such request and shall immediately notify the person making such request of such determination and the reasons therefor.

. "[R]equesting parties constructively exhaust their available administrative remedies with respect to their request if the responding agency fails to comply with the statutory deadlines."

(citing ). But "[i]f the Government can show exceptional circumstances exist and that the agency is exercising due diligence in responding to the request," courts "may retain jurisdiction and allow the agency additional time to complete its review of the records."

;.

Even though Defendants do not invoke 's exceptional-circumstances exception in

the Motion or subsequent pleadings, it appears to be the argument Defendants effectively offer here. Their rationale breaks down into two parts: there are a lot [*4] of documents to review (Dkt. #10 at pp. 2-3; Dkt. #12 at p. 3; Dkt. #15 at p. 2), and FOIA-response resourceshave lessened due to the COVID-19 pandemic (Dkt.#10 at pp. 3-4; Dkt. #12 at p. 2; Dkt. #15 at p. 2).

The latter of these arguments is entirely understandable. The COVID-19 pandemic has severely disrupted the normal functioning of government, and processing FOIA requests is no exception. OFF. OF

INFO. POL'Y, U.S. DEP'T OF JUST., ,

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of 5

https://www.justice.gov/oip/guidance-agency-foia-administration-light-covid-19-impacts (last updated May 28, 2020). If the COVID-19 crisis is not an "exceptional circumstance" under , the Court is unsure when the exception would ever apply.

Notwithstanding, the problem with the Motion Defendants advance is the due-diligence element required by FOIA. ("If the Government can show exceptional circumstances exist and that

. . . ." (emphasis added)). For one thing, Defendants' requested relief is too pliable for the Court's comfort. The Motion initially requests "an additional three months to complete the tasks" described [*5] therein, at which time Defendants plan to provide the Court with "an updated search status" and proposed "production schedule" (Dkt. #10 at p. 4). In their reply, Defendants reaffirm that their request is "reasonable" and "in good faith" (Dkt. #12 at p. 1). Only in their sur-reply do Defendants—for the first time—begin to outline what a production schedule look like ( Dkt. #15 at p. 2). Even in these extraordinary times, the degree of malleability Defendants propose for the proceedings is unreasonable. FOIA "represents a strong Congressional commitment to transparency in government through the disclosure of government information."

, ,. The

shapeless nature of the relief Defendants seek is anything but transparent.

As well, the rate at which Defendants intend to process and produce documents is murky at best. The FBI has identified "over 20,000 pages" potentially within the scope of Plaintiff's requests (Dlt. #10 at p. 2). The DOJ "is continuing to review" its search results, and to this point, has "similarly located tens of thousands of pages"

possibly within the purview of Plaintiff's requests (Dkt. #10 at p. 3). Defendants state they still need to review these documents [*6] "to determine responsiveness and, as to the responsive material, to make release determinations in accordance with applicable exemptions" (Dkt. #12 at p. 3).

The Court recognizes the "unprecedented workload" Defendants face on this front given current global circumstances (Dkt. #12 at p. 3). But the proposed processing rate is impermissible. Given the information currently before the Court, processing 250 pages per month during this reduced-staffing period and 500 pages per month when staffing returns to normal would be an unreasonable delay. As Plaintiff indicates, this rate would mean that at best, producing just the FBI materials would take three years and fourth months, and

at worst, nearly seven years (Dkt. #18 at p. 4).1

, (explaining that when Congress created FOIA's

due-diligence requirement, it did not intend for production to take years). Further, this timeline is only for the FBI's processing and production—the information the Court currently has does not relate where the DOJ is in its process. All that is provided in this regard is that the average time it takes the DOJ to work through requests of this nature is "about 10 months" (Dkt. #10 at p. 3).

FOIA sets out [*7] temporal guidelines for its procedures to ensure expeditious processing and production of information under the statutory scheme.

("FOIA was created to foster public awareness,

1 While Plaintiff's argument regarding timeliness is well taken (Dkt. #13 at pp. 1-2; Dkt. #18 at p. 4), the Court agrees with Defendants that comparisons to document production by private entities is inapt (Dkt. #15 at p. 1).

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of 5

and failure to process FOIA requests in a timely fashion is 'tantamount to denial.'" (quoting H.R. REP. NO. 93-876, at 6 (1974)). The vague and dragged-out timeline Defendants suggest cannot be sustained without a greater showing of exceptional circumstances because "stale information" produced pursuant to FOIA requests "is of little value." .Granting the relief Defendants seek would thwart FOIA's "basic purpose" of "open[ing] agency action to the light of public scrutiny."

(internal quotation marks omitted).

To be sure, were Defendants to (1) explain the exceptional circumstances associated with the handling of Huddleston's FOIA requests more precisely, and (2) present a less amorphous processing and production schedule, the Court would be open to considering a reasonable delay of the proceedings. But given the Motion and relevant pleadings, the Court does not find the exceptional-circumstances FOIA exception applicable and utilizes its inherent authority to extend the scheduling order deadlines for an appropriate [*8] length of time.

It is therefore that Defendants' Motion to Stay Scheduling Order Deadlines (Dkt. #10) is hereby

and . It is the Scheduling Order in this case is

amended as follows:

Go to table1

.

.

/s/ Amos L. Mazzant

AMOS L. MAZZANT

UNITED STATES DISTRICT JUDGE

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of 5

Return to related document textApril 23, 2021 Deadline for Defendants' Complete

Production of Documents and Index

May 24, 2021 Defendants' Motion for Summary Judgment

June 23, 2021 Plaintiff's Opposition and Cross-Motion

for Summary Judgment

July 7, 2021 Defendants' Reply and Opposition

July 21, 2021 Plaintiff's Reply

Return to related document text

App000600


NeutralAs of: December 7, 2021 4:43 AM Z

United States District Court for the Western District of Texas, El Paso Division

January 28, 2021, Decided; January 28, 2021, Filed

EP-19-CV-00236-FM

2021 U.S. Dist. LEXIS 16469 *; 2021 WL 289548

DIOCESAN MIGRANT & REFUGEE SERVICES, INC., Plaintiff, v. UNITED STATES IMMIGRATION AND CUSTOMS ENFORCEMENT, Defendant.

documents, records, attorney's fees, redactions, exemptions, immigration, requests, Sheet, pages, deadline, field office, hourly rate, costs, asylum, email, billing, seekers, reasonable basis, disclosure, searches, withhold, inlaw, prevailed, lodestar, thirty-three, calculate, practices, uncover, reasonable attorney's fees, privileges

[*1] For Diocesan Migrant & Refugee Services, Inc., Plaintiff: Christopher Benoit, LEAD ATTORNEY, Law Office of Lynn Coyle, PLLC, El Paso, TX; Lynn A. Coyle, The Law Office of Lynn Coyle, PLLC, El Paso, TX.

For United States Immigration and Customs Enforcement, Defendant: Manuel Romero, LEAD ATTORNEY, U.S. Attorney, Western District of Texas, El Paso, TX.

FRANK MONTALVO, UNITED STATES DISTRICT JUDGE.

FRANK MONTALVO

Before the court are "Plaintiff's Opposed Application for Attorney Fees and Costs" ("Motion") [ECF No. 56], filed November 2, 2020 by Diocesan Migrant & Refugee Services, Inc. ("DMRS"); "Response to Plaintiff's Application for Attorney Fees and Costs" [ECF No. 65], filed November 23, 2020 by United States Immigration and Customs Enforcement ("ICE"); and "Plaintiff's Reply to Defendant's Response to Plaintiff's Application for Attorney Fees and Costs" ("Reply") [ECF No. 66], filed November 25, 2020. After due consideration of the Motion, Response, Reply, and applicable law, the Motion is .

In 2019, the United States government implemented a policy titled the Migrant Protection Protocols ("MPP"). Pursuant [*2] to the MPP, selected asylum seekers

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must remain in Mexico while they wait for U.S.

immigration judges to hear their asylum cases.1 The

MPP was first implemented at the San Ysidro port of

entry in January 2019.2 It was then implemented at the

El Paso port of entry in May 2019 and at the Laredo and

Brownsville ports of entry later in 2019.3

DMRS is a non-profit organization that provides know-your-rights information and legal representation for asylum seekers prior to their appearances before an

immigration judge.4 It provided know-your-rights

information to asylum seekers subject to the MPP during the brief time the asylum seekers were in the

United States prior to immigration hearings.5 In June

2019, ICE and the United States Department of Justice Executive Officer for Immigration Review ("DOJ-EOIR") informed DMRS that it would no longer be permitted to provide know-your-rights-information to asylum seekers

waiting for immigration hearings.6

On July 1, 2019, DMRS submitted a request for information to ICE pursuant to the

7 It

1 "Findings of Fact and Conclusions of Law" 3, ECF No. 44, entered Oct. 19, 2020.

2

3

4 "Plaintiff's Original Complaint" ("Compl.") 2 6, ECF No. 1, filed Aug. 22, 2019; "FOIA Request," Ex. 1. Plaintiff's Opposed Application for Attorney Fees and Costs" ("Mot."), ECF No. 56, filed Nov. 2, 2020, "Declaration of Melissa M. Lopez" 3, ECF No. 56-1, Ex. 3.

5

6 at 2 7.

7 Findings of Fact and Conclusions of Law 3.

sought records related to the implementation of the MPP and asylee access to attorneys prior to

immigration hearings. [*3] 8 ICE did not produce any

responsive documents within the twenty-day statutory

deadline.9 DMRS filed suit to compel production on

August 22, 2019.10

Toni Fuentes ("Fuentes"), a Deputy FOIA Officer for ICE, was immediately responsible for supervising ICE

responses to requests for records under FOIA.11 Due to

an ICE administrative error, ICE did not become aware of DMRS's FOIA request until after the initiation of this

lawsuit.12 Fuentes assisted in locating DMRS's FOIA

request, at which time she assigned the request to the litigation team of the ICE FOIA Office for expedited

processing of the request.13

Approximately four-and-a-half months after the statutory deadline to respond, on December 16, 2019, ICE notified DMRS it identified ninety-two pages of

potentially responsive records.14 Ten pages were

provided in full, twenty-eight pages contained redacted information, fourteen pages were deemed non-responsive or duplicates, and the remaining forty pages required "consultation with other agencies or components" and ICE stated they would "be produced

8

9 at 5. .

10 Compl.

11 at 2-3.

12 "Transcript of Bench Trial" 15, ECF No. 63, filed Nov. 16, 2020.

13 at 13.


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at a later date."15 On May 22, 2019, DMRS filed its

motion for summary judgment arguing ICE had not conducted a search reasonably [*4] calculated to uncover responsive records and had not met its burden to show that records it withheld were exempt from

disclosure.16

On May 29, 2020, nine months after Plaintiff filed suit and almost eleven months after Plaintiff sent its original FOIA request, ICE forwarded the pages requiring

consultation to other agencies for review.17 ICE

admitted that a second administrative error prevented

timely referral of these documents.18 While the

consultations were pending, ICE filed five motions for extensions of the deadline to respond to DMRS's motion for summary judgment. ICE finally responded on June 25, 2020, twenty days after the original deadline. That same day, almost eleven months after the statutory deadline, ICE produced thirty-three of the forty pages

requiring consultation.19 ICE did not address these

documents in its response. DMRS challenged redactions to the thirty-three pages produced after its motion for summary judgment but withdrew its

objections to previously produced materials.20

15

16 "Plaintiff's Motion for Summary Judgment," ECF No. 14, filed May 22, 2020.



19 Findings of Fact and Conclusions of Law 2. (providing a twenty-day deadline,

excluding weekends and holidays for agencies to respond to FOIA requests).

20 "Plaintiff's Reply to Defendant's Response to Plaintiff's

On October 5, 2020 the court held a bench trial to resolve two issues: 1) whether ICE conducted a search reasonably calculated to uncover responsive records; and 2) whether [*5] redactions pursuant to

("exemption (b)(5)") to the thirty-three pages produced June 25, 2020 were exempt from

disclosure.21 The parties were present and represented

by counsel. Fuentes was ICE's sole witness.

One subdivision of ICE Enforcement and Removal Operations ("ERO") is ERO Field Operations ("FOPS"), the office responsible for providing MPP guidance to all

ERO field offices.22 After consideration of Fuentes's

testimony, the court found ICE was on notice that DMRS's request sought communications between ICE ERO agents and their contractors at the field office level about implementation of the MPP; correspondence to ICE ERO officers and, their contractors who were responsible for movement and custody of respondents subjected to the MPP; emails by or between ERO field offices where the MPP was implemented; and emails of guidance between officers and contractors at the field office level regarding the MPP participants' access to

counsel before their immigration court hearings.23

The court also found:ICE program offices have no written guidelines on

how to conduct searches for records responsive to

Motion for Summary Judgment" 2-3, ECF No. 29, filed July 29, 2020.


22 at 9.

23 at 4-5.

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FOIA requests.24

Each program office within ICE has its ownguidelines for record keeping, [*6] retention

schedule, and records liaison officers.25

Fuentes instructed her points of contact ("POCs")in three program offices to conduct searches forresponsive documents: the ICE Office of Policy,ICE Office of the Principal Legal Advisor ("OPLA"),

and ICE ERO.26

No uniform set of search terms was used across

the various ICE program offices.27

No POC described to what extent, if any, theytook into consideration the particular record keepingpractices of their respective program offices in

searching for responsive documents.28

ERO FOPS, the office responsible for providingMPP guidance to all ERO field offices, determinedthe requested information did not fall in its area ofresponsibility and did not conduct any search for

responsive documents.29

The court then turned to the thirty-three pages of redacted documents produced to Plaintiff after consultation with Customs and Border Patrol and the

24

25 at 6.

26


28

29 at 9. Memorandum from Nathalie R. Asher, Acting Executive Associate Director, U.S. Immigration and Customs Enforcement, to Field Office Directors, Enforcement and Removal Operations, "Migrant Protection Protocols Guidance" (Feb. 12, 2019).

Department of Homeland Security Office of Privacy.30

ICE provided only a letter to accompany the produced

documents.31 Two paragraphs in the letter address the

redactions made pursuant to .32 The

letter did not identify which privilege supported each

redaction made under [*7] redaction .33 Nor did

either provide DMRS with any factual basis for the application of to any individual

redaction.34 Fuentes's testimony was equally

inadequate.

Upon conclusion of ICE's case, DMRS moved for judgment as a matter of law as to both issues. The court granted the motion and, on October 19, 2020, entered corresponding "Findings of Fact and Conclusions of Law" [ECF No. 44]. The court ordered that the thirty-three pages originally produced to DMRS on June 25, 2020 be unredacted and produced to DMRS by October

26, 2020.35 It also ordered ICE to conduct a new search

for documents responsive to DMRS's FOIA request by

November 2, 2020.36

On November 2, 2020, the deadline for ICE to conduct its new search, ICE informed the court it had not yet conducted any search and moved for an extension of


31 at 12.

32

33 at 12.

34

35 "Final Judgment" 1, ECF No. 45, entered Oct. 19, 2020.

36

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time do so.37 ICE requested the deadline be extended

to November 23, 2020 with respect to a search for responsive records from the El Paso Field Office and asked for an additional thirty days upon completion of a search of the El Paso Field Office to search for responsive records from the San Antonio and San

Diego Field Offices.38 ICE did not express any

concern [*8] about the procedural feasibility of the deadline, merely citing counsel's personal circumstances. The court granted ICE an additional extension of all search deadlines to November 23,

2020.39

A week after the second deadline, on November 30, 2020, ICE moved for yet another extension of time to

comply with the court's order.40 For the first time, ICE

informed the court of the procedure it intended to follow in conducting its new, more thorough, search for responsive documents. ICE also expressed concern for the impossibility of the court's deadline in light of the search requirements. ICE informed the court it conducted an examination of its records utilizing thirteen search terms in records from forty-nine custodians. That examination identified approximately 2.3 million

potentially responsive documents.41 After using

software to extract irrelevant and duplicative documents,

37 "Defendant's Unopposed Motion for Extension of Time, or in the Alternative, Motion to Alter or Amend a Judgment," ECF No. 53, filed Nov. 2, 2020.

38 at 8.

39 "Order Granting in Part and Denying in Part Motion for Extension of Time" 2, ECF No. 57, entered Nov. 3, 2020.

40 Defendant's Amended Unopposed Motion for Extension of Time to Produce Documents," ("Nov. Mot. For Extension") ECF No. 70, filed Nov. 30. 2020.

41 at 7-8.

approximately 86,000 potentially responsive documents

remained.42 ICE then assigned thirty percent of its FOIA

staff to conduct first-line review full-time.43 Ten to fifteen

attorneys would dedicate half of every work day to

second-line review.44 ICE estimated staff would require

four months to produce all responsive records [*9] from

the El Paso field office.45 Thereafter, the parties would

confer to present a new scheduling order for remaining

documents.46 The court entered an order granting the

extension.47 ICE did not appeal any part of the court's

judgment. As a result, the court's Findings of Fact and Conclusions of Law are now the law of the case. ICE

cannot contest either.48

FOIA states "[t]he court may assess against the United

42 at 11.

43 at 47.

44 at 48.

45 at 59.

46 Nov. Mot. For Extension 59.

47 "Order Granting Second Motion for Extension of Time," ECF No. 71, entered Dec. 1, 2020.

48

(The law-of-the-case doctrine "posits that when a court decides upon a rule of law, that decision should continue to govern the same issue in subsequent stages in the same case.")

(The collateral estoppel doctrine stands for the principle that "when an issue of ultimate fact has once been determined by a valid and final judgment, that issue cannot again be litigated between the same parties in any future lawsuit.")

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States reasonable attorney fees and other litigation costs reasonably incurred in any case under this section

in which the complainant has substantially prevailed."49

Accordingly, the court must apply a two-prong test to determine: (1) "whether a plaintiff has substantially prevailed" and, if so, (2) "whether the plaintiff

receive fees."50

A Plaintiff has "substantially prevailed" and therefore satisfied the first prong if it obtained requested relief

through a judicial order.51 The second prong, also

known as the "entitlement" prong, requires courts to consider: "(1) the benefit to the public deriving from the case; (2) the commercial benefit to the complainant; (3) the nature of the complainant's interest in the [*10] records sought; and (4) whether the government's withholding of the records had a reasonable basis in

law."52 The entitlement prong requires courts to conduct

analysis through the lens of the three fundamental purposes of FOIA's legal fee provision. The provision is designed: (1) "as an incentive for private individuals to pursue vigorously their claims for information" and overcome barriers "that government may erect in an effort to escape compliance with the law;" (2) to "deter the government from opposing justifiable requests;" and (3) "to punish the government where such opposition is

unreasonable."53 An award of attorneys' fees is

49 .

50 (emphasis in original).

51 ; .

52 .

53

.

particularly appropriate where "'government officials have been recalcitrant in their opposition to a valid claim or have been otherwise engaged in obdurate

behavior.'"54

The Final Judgment entered in this action definitively establishes DMRS substantially prevailed in its FOIA

action as this court granted all of the requested relief.55

This is not contested. Accordingly, the court proceeds to a determination of whether DMRS should receive attorney fees in light of the circumstances of the case and the [*11] essential purposes of the FOIA legal fee provision.

1. The Benefit to the Public Deriving from the Case

"The basic purpose of FOIA is to ensure an informed citizenry, vital to the functioning of a democratic society, needed to check against corruption and to hold the

government accountable to the governed."56 Viewing

the public benefit factor through the lens of FOIA's high-minded central purpose, attorneys fees are more appropriate "where the complainant's victory is likely to add to the fund of information that citizens may use in

54 (quoting S.Rep. No. 93-854, at 19 (1974)).

55 ("a complainant has substantially prevailed if the complainant has obtained relief through . . . a judicial order . . ."); .

56

.

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making vital political choices."57 Courts take into

consideration "the degree of dissemination and the likely public impact that might be expected from a particular

disclosure."58

DMRS requested information about ICE's decision to prohibit asylum seekers' access to attorneys and to know your rights information. Denial of access to counsel and rights information has broad-ranging due process consequences for asylum seekers fleeing persecution. The documents responsive to DMRS's FOIA request are very likely to be of significant consequence to the large numbers of asylees and their advocates. As DMRS intends to use the requested records to "determine how to move [*12] forward with providing information and representation to asylum

seekers in the MPP program,"59 it has already begun

the process of making documents obtained through this litigation available to other non-profit legal service organizations in the El Paso area, fellow advocates, and

members of the press.60

Our nation's comprehensive immigration policy has been part of the national dialogue for well over a decade. In the recently concluded presidential cycle it figured prominently in the campaigns of every presidential candidate and most candidates seeking federal office. An element of that policy is the treatment of refuge and asylum seekers. Responsive documents would provide valuable insight into the execution of a

57

.

58 .

59 Mot. 5.

60 Mot., "Declaration of Melissa M. Lopez" 3, ECF No. 56-1, Ex. 3.

rapidly evolving and controversial policy dealing with that segment of the immigrants pursuing admission to our country. As this information is both of public concern and useful to political decision making, the diffusion of documents will spread beyond legal service providers to the wider public. An award of attorney fees will foster the spirit of private litigants to vigorously pursue claims for information vital for democratic society and discourage the government from the [*13] cavalier treatment of appropriate and lawful requests such as DMRS is pursuing.

The public benefit is not reduced by the change in administration since the initiation of this lawsuit and before ICE has finished reviewing and producing all responsive documents. The delays are completely attributable to ICE's own administrative errors, absence of clearly defined methods and procedures to determine places and databases to search, lack of effective and comprehensive procedures for adequately processing FOIA requests, and repeated requests for extensions of deadlines. ICE's ineptitude in responding to valid requests for information and failure to comply with this court's deadlines cannot be counted in its favor. To do so would make a mockery of the accountability principles underlying FOIA.

ICE's handling of this FOIA request is precisely encompassed in the Fifth Circuit's holding that attorney fees are particularly appropriate where "'government officials have been recalcitrant in their opposition to a valid claim or have been otherwise engaged in obdurate

behavior.'"61 Potential FOIA complainants must be

incentivized to pursue meritorious claims without fear that the duration of the lawsuit [*14] would make the information sought "old news," no longer in the public

61

(quoting S.Rep. No. 93-854, at 19 (1974)).

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eye, and defeat a motion for compensation by simply delaying response. Therefore, this factor weighs strongly in favor of granting attorney fees.

2. The Commercial Benefit to the Complainant andNature of Complainant's Interest in the Records Sought

When the commercial benefit to a plaintiff and the nature of the plaintiff's interest in records sought are

similar it is useful to consider these factors together.62

In weighing the commercial benefit factor, courts consider whether the party requesting fees is indigent or a non-profit organization rather than a large corporate

interest.63 Similarly, the nature of the complainant's

interest weighs in favor of granting attorney fees if the plaintiff seeks to protect the public interest, rather than

merely a private interest.64 These factors further

congressional intent that the prohibitive costs of litigation not exclude the indigent and public interest

groups from pursuing relief.65

There is no commercial benefit to DMRS in the records sought. DMRS is a non-profit organization that provides know-your-rights information and legal representation to indigent asylum seekers. [*15] Its central purposes in seeking the documents are to protect its constituents' due process rights and to facilitate the fair adjudication of political asylum claims. Receipt of responsive records furthers DMRS's organizational purpose by bolstering its ability to protect the public interest in the administration of justice in the immigration system. Responsive records

62

63

.

64

65 (citing S.Rep. No. 854, 93d Cong., 2d Sess. 19 (1974)).

are also likely to raise public awareness of issues of political importance through the distribution of responsive records to other immigrant advocacy groups and the media. As such, both factors weigh in favor of granting attorney fees.

3. Whether the Government's Withholding of theRecords had a Reasonable Basis in Law.

FOIA requires federal agencies to make their records promptly available to any person who makes a proper

request for records.66 "[T]he threshold question in any

FOIA suit is whether the requester can even the documents the character of which determines whether

they can be released."67 Accordingly, the FOIA statute

provides that, when the government withholds information from disclosure, the agency has the initial burden to prove that the information is exempt

from disclosure.68 This court's findings [*16] of fact

document the abysmal inadequacy of the search and the unsupported redactions. In considering whether to award attorney fees, the threshold is lower. The government's withholding needs only to have had a

reasonable basis in law for ICE to avoid attorney fees.69

ICE showed no reasonable basis to withhold the documents.

a. Adequacy of Search

ICE failed to establish even a colorable basis in law exists to support the adequacy of its search for

66 .

67

.

68 ;.

69 .

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documents responsive to DMRS's FOIA request. "Even when an agency does not deny a FOIA request outright, the requesting party may still be able to claim 'improper' withholding by alleging that the agency has responded

in an inadequate manner."70 An agency's search is

adequate if it is "reasonably calculated to uncover all

relevant documents."71 "The adequacy of an agency's

search is measured by a standard of reasonableness and is dependent upon the circumstances of the

case."72 The focus is on the reasonableness of the

search, not the result.73 An agency must "make more

than perfunctory searches and, indeed, [] follow through

on obvious leads to discover requested documents."74

There is no reasonable basis in law to believe ICE's search [*17] was reasonably calculated to uncover all responsive documents. Testimony about ICE's search was inconsistent and generalized. Fuentes described general ICE procedure for responding to FOIA requests without knowledge of the specifics. Fuentes did not

70

(citations omitted).

(recognizing the judicial authority conferred by the FOIA to devise remedies for agencies contravening the statute through improper withholdings).

71

;.

72

73

.

74

.

conduct any search herself.75 Nor could she testify as to

the precise search procedure—Fuentes conceded her knowledge was limited to information on search forms

POCs provided to her office.76 ICE had all the time it

requested to prepare for trial and to marshal all evidence it deemed appropriate. Even so, it did not call a single witness able to explain the rationale for the search conducted at any single program office.

In explanation of ICE's failure to conduct a methodical agency-wide search for responsive records, Fuentes stated the agency was "young" and "playing catch-up,"

seemingly acknowledging deficiencies.77 In an apparent

contradiction, she then said the reason for the lack of uniformity was to honor the subject-matter expertise

within individual program offices.78 Since record

keeping practices vary across program offices, Fuentes reasoned, ICE conducts non-uniform searches.

Due to this model, Fuentes could not testify as to either the [*18] record keeping or searching practices of any program offices or their subdivisions. POCs did not provide that information in their search forms. The returned search forms indicate different search terms were used across program offices without any apparent reason for the lack of uniformity. Fuentes could not say whether a given search was reasonable in the context of the recordkeeping practices of a program office as she was not familiar with those practices and the POCs provided no explanation.

ICE's deference to the subject-matter expertise of


76 "Transcript of Bench Trial" 35-36, 83-84, ECF No. 63, filed Nov. 16, 2020.

77 at 19-20.

78 at 20.

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individuals within each program office is neither strategic nor efficient. It shows indifference to the purpose of the search. Without testimony about each program office's record keeping practices, ICE cannot show the search process was reasonably calculated to uncover all responsive documents.

The search was too narrow to be expected to uncover all responsive documents. Only five individuals in an agency of several thousand searched their email

accounts for responsive correspondence.79 These

individuals used a variety of inconsistent search terms. The entirety of the search within the ERO Enforcement Division records was for a single search term [*19] within the Deputy Assistant Director's email account: the

acronym "MPP."80 Fuentes could not say with any level

of assurance that this search uncovered responsive

documents containing the spelled-out acronym.81 Some

individuals may have searched only within specific

folders.82 Some may have excluded deleted, archived,

or sent emails by searching only within their inboxes.83

Fuentes could not be sure and could only interpret the returned search forms.

ICE failed to show it conducted a reasonable search within ERO FOPS. DMRS's request sought communications about guidance and instruction to employees regarding day-to-day movement of MPP participants wherever the MPP was established. FOPS


80 at 95.

81 at 96.

82 at 87.

83 at 88.

is responsible for providing guidance and coordination

to the twenty-four ERO field offices.84 ERO field offices

are responsible for the custody of all MPP participants

from the port of entry to the immigration court.85 A

publicly available memorandum by the Acting Executive Associate Director of ICE instructs field office directors to assign a lead POC for MPP issues within their

offices.86 The memorandum tasks these POCs with

issuing local operational guidance applicable to the

MPP.87 These facts conclusively indicate [*20] FOPS is

reasonably likely to have records responsive to DMRS's FOIA request. They also indicate ICE was aware that field offices possess records responsive to FOIA requests for information related to the MPP.

Inexplicably, FOPS determined DMRS's FOIA request did not fall within its area of responsibility and declined to conduct any search. It is troubling FOPS disregarded the plain language of a publicly available memo in determining it had no records responsive to DMRS's FOIA request. There is no reasonable basis in law to support ICE's inadequate search.

b. Exemptions

ICE gave no reasonable basis in law to redact the thirty-three pages it produced on June 25, 2020. When the applicability of an exemption to disclosure under FOIA is in dispute, an agency is required to provide a detailed



86 Memorandum from Nathalie R. Asher, Acting Executive Associate Director, U.S. Immigration and Customs Enforcement, to Field Office Directors, Enforcement and Removal Operations, "Migrant Protection Protocols Guidance" (Feb. 12, 2019).

87

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justification for exemption claims, correlating justifications for refusal to disclose with actual portions

of records claimed to be exempt.88 A common way in

which agencies do so is through a index.89 In

, the D.C. Circuit held that a system of itemizing and indexing exemptions' legal and factual bases would easily remedy the problem of conclusory and

generalized allegations of exemptions. [*21] 90 This

procedure makes clear the factual nature of the information sought and the specific reason it falls within

the statutory exemption asserted.91 Since , it

has become standard practice for agencies to supply

the court with a index.92

Under , an agency can withhold information covered by a recognized evidentiary or

discovery privilege.93 protects from

disclosure:inter-agency or intra-agency memorandums or letters that would not be available by law to a party other than an agency in litigation with the agency, provided that the deliberative process privilege shall not apply to records created 25 years or more

88 (citing

.

89 .

90 .

91 .

92 ;;

.

93

.

before the date on which the records were

requested.94

Thus, " incorporates the privileges which the government enjoys under the relevant statutory and

in the pretrial discovery context."95 Three

common law privileges encompassed in include: (1) the attorney work-product privilege;

(2) the attorney-client privilege; and (3) the

governmental deliberative process privilege.96

After repeated opportunities to demonstrate to this court how applies to the records ICE sought to [*22] withhold, ICE did not meet its burden to support exempting any information redacted pursuant to

from disclosure. ICE presented no evidence at either the summary judgment phase or at trial supplying the factual or legal basis for any application of . Although settled law establishes the preparation of a Vaughn index, ICE did not generate one. ICE simply provided a brief letter to accompany the thirty-three pages of responsive documents at issue. The letter stated that redactions under qualified for protection under one or more of the three named privileges, without specifying which, and without any factual basis for the application of to any individual redaction.

ICE's only witness shed no more light on the factual

94 .

95

(citations omitted) (emphasis in original).

96

.

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basis for the exemptions. Fuentes admitted she was not involved in redacting the documents at issue and

therefore had no personal knowledge to speak of.97 Nor

did she seem to have secondary knowledge on which the court could rely due to her role as agency representative. Fuentes stated she reviewed the

exemptions claimed and agreed with them.98 However,

when asked directly about why entire pages had been subject [*23] to , she stated she did not

know what the pages contained.99 When asked about a

specific redacted page, she could not say whether it was the end of the preceding document, an attachment,

or part of a subsequent document.100

Fuentes's lack of knowledge regarding the substance of the redactions often led her to speculate to fill in the gaps. When asked whether redacted emails were sent to agents executing the MPP on-the-ground, she responded, "they do not appear that way as

redacted."101 In reference to another redacted email,

Fuentes stated that, as two attorneys were included among other undisclosed recipients, she believed the

email to contain legal advice.102 She later admitted she

did not know who else received the email and was aware emails are not necessarily privileged just

because an attorney is included in an email chain.103

97 "Transcript of Bench Trial" 57-58, ECF No. 63, filed Nov. 16, 2020.

98 at 120.

99 at 144.

100

101 at 103.

102 at 140-41.

103 "Transcript of Bench Trial" 146, ECF No. 63, filed Nov. 16,

Fuentes was not only uncertain of the content of responsive records; she was uncertain and inconsistent in providing underlying reasons for redactions. She alternated between identifying the specific privilege applied and admitting she could not state with any confidence which privilege supported each redaction. She openly speculated about which privilege [*24] may have applied based on context clues in the released portions. More than once, she equivocated, stating perhaps the redactor had relied on one of the three

privileges cited or perhaps on all three.104 Fuentes's

testimony was not reliable. Even had Fuentes confidently testified as to the privileges relied upon by

the redactors, she is not a lawyer.105 She therefore

does not have the education or training to provide an explanation as to a particular privilege was invoked.

While Fuentes was knowledgeable about the procedure ICE uses to apply exemptions generally, she was unable to bridge the gap between that procedure and the factual basis for exemptions applied in this case. Both the fundamental principle of public access to government documents and the general principle of full agency disclosure require agency representatives to have more than mere confidence in the procedure followed. They require clear statements of both the factual nature of the information withheld and whether it

falls within a specific statutory exemption.106 Without

2020.

104 at 146-47.

105 at 132-33.

106

("The central issue . . . is whether the [evidence] submitted by [the agency] . . . sufficiently identif[ies] the documents at issue, including the relevant information contained in each document, and explain[s] why the asserted exemptions justify

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either, the explanation is not only legally insufficient, it lacks any reasonable basis in the law. ICE did less than the bare minimum to justify its [*25] exemptions and instead attempted to shift the burden to the court and to DMRS. This forced DMRS to expend considerably more in attorney labor and fees to litigate exemptions to documents produced at the eleventh hour and without the easy remedy of a index. Therefore, the final factor in the entitlement prong, like all others, weighs in favor of granting attorney fees.

As DMRS substantially prevailed and is entitled to attorney fees, the court must consider whether the

amount requested is reasonable.107 District courts have

broad discretion in calculating reasonable attorney fee

awards.108 Reasonable attorney fees are determined in

two steps. First, the court calculates the "lodestar."109

The lodestar is the product of the reasonable hourly rate multiplied by the number of hours reasonably expended

on the litigation.110 The party requesting fees bears the

burden of establishing the reasonableness of fees,

withholding.").

107 ("The court may assess against the United States reasonable attorney fees and other litigation costs reasonably incurred . . .").

108

;.

109

.

110 .

hours billed, and billing judgment exercised.111 There is

a presumption that the lodestar amount is a reasonable

fee.112

In step two, the court may adjust the fee award up or down after consideration of the factors articulated [*26] in not

already included in the calculation of the lodestar.113

However, neither party requests attorney fees depart from the lodestar. Accordingly, the court will not advance to the second step of the attorney fee inquiry and calculation of the lodestar alone will determine the amount of the attorney fee award.

1. Compensable Hours

To calculate the lodestar, a district court must first determine the compensable hours from the attorney's

time records, including only hours reasonably spent.114

Each hour claimed must be supported by attorney billing

records.115 The court must exclude "excessive,

111

.

112

.

(describing the limited circumstances in which an adjustment to the lodestar is permitted).

113 .

(holding that factors that are subsumed in the calculation of the lodestar may not provide an independent basis for increasing the fee award).

114 .

115 .

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of 17

redundant, or otherwise unnecessary" hours.

DMRS requests compensation for 125.7 hours worked

by lead counsel, Christopher Benoit ("Benoit").116 In

support, it submits a billing statement detailing hours worked by Benoit. According to the billing statement, the billed hours are reduced from a total of 132 hours to

eliminate redundant or administrative hours.117 In order

to prevent duplication of work, DMRS also does not request compensation for hours worked by co-counsel

or counsel's administrative assistant.118 At the time

DMRS filed its Motion DMRS estimated [*27] an additional ten hours of work would be performed to cooperate with ICE in creating and completing a new

search in compliance with this court's order.119 ICE

disputed only that the FOIA fee shifting provision permitted compensation for work yet to be

performed.120 DMRS then submitted documentation of

an additional 12.8 hours worked in compliance with the court's order to construct a new search and amended its request to substitute these hours for the prospective

fees.121 These hours are therefore no longer

speculative and will be considered alongside all other hours.

The hours billed reasonably reflect the time spent on litigation and are compensable. FOIA matters present

116 Mot. 10.

117 Mot., "19-cv-00236 Billing Statement" 2, ECF No. 56-1, Ex. 1-B.

118 Mot. 8.

119 at 10.

120 Resp. 3 fn. 2.

121 "Plaintiff's Reply to Defendant's Response to Plaintiff's Application for Attorney Fees and Costs" 6, ECF No. 66, filed Nov. 25, 2020.

legal complexities requiring a significant investment of time to fully research and brief. This case proceeded to trial, which required significant time to prepare opening and closing statements, exhibits, an expert witness, and cross-examination. The quality of pleadings submitted and trial advocacy displayed by Mr. Benoit was of the first order. It is remarkable that he and his litigation team did so much quality work in the time claimed.

Benoit represents DMRS on a contingent fee basis.122

He charged no hourly rate and will [*28] not be compensated beyond court awarded attorney fees. Benoit exercised reasonable billing judgment by omitting any charge for time contributed by co-counsel and his administrative assistant. The court finds no excessive, redundant, or otherwise unnecessary hours in counsel's billing statement.

Besides the usual time requirement for actions proceeding to trial, this case presented unusual complications resulting from the government's own obstructionist behavior. ICE's repeated delays and administrative errors needlessly extended the duration of this action and required numerous phone calls, emails, and conferences that would otherwise have been unnecessary. ICE also complicated the summary judgment phase by untimely producing responsive documents after DMRS filed its motion and the dispositive motion deadline had passed, thereby preventing DMRS from disputing redactions to those documents before its reply. In turn, as both parties had not had an opportunity to brief the issue, this court was unable to address the contested redactions at that

phase and carried the issue over to trial.123

122 Mot. 7.

123 "Order Denying Motion for Summary Judgment" 6, ECF No. 30, entered Aug. 25, 2020;

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Even now, ICE continues to stall and delay its search for responsive documents. For the first time, [*29] ICE claims the substantial backlog of FOIA requests and its limited personnel makes timely compliance impossible. However, administrative backlog does not form a reasonable basis in law to withhold responsive

documents.124

As ICE did not have a faintly colorable claim that its search complied with the statute, this newfound claim of impossibility proves how indifferent ICE was to its statutory duty. Had ICE responded in conformity with the statute, the enormity of the task they now claim would have been identified in the summer of 2019 and not in the winter of 2020. Meanwhile, DMRS and its counsel must continue to expend time and resources pursuing its claim, even after completely prevailing at trial. DMRS has met its burden to show the reasonableness of the 138.5 hours billed by Benoit.

2. Hourly Rate

Next, the district court must "select an appropriate hourly rate based on prevailing community standards for

attorneys of similar experience in similar cases."125

"Generally, the reasonable hourly rate for a particular community is established through affidavits of other

.

124

(holding that attorney fees cannot be denied on the reasonableness of the government's position where the government cites processing backlogs, confusion, and administrative error, because these "are practical explanations, not reasonable bases.").

125 .

attorneys practicing there."126

DMRS requests an hourly rate of 325-375.127 In

support of its requested rate, DMRS provides a [*30] declaration from Benoit, expanding on the time and

effort expended by counsel;128 a declaration from

attorney Lynn Coyle, attesting to both the work done by Benoit in this case and the prevailing rate for

comparable legal work;129 and a declaration from John

P. Mobbs ("Mobbs"), a seasoned El Paso attorneyqualified as an expert in attorney fees, opining that thefees requested in this case are below the reasonable

contingency fee range in El Paso.130

ICE contends the proposed rate is excessive and unreasonable as it exceeds the hourly rate of El Paso attorneys with comparable experience as listed in the 2015 State Bar of Texas Hourly Rate Fact Sheet ("Fact

Sheet").131 ICE cites to a string of unreported district

court opinions relying on the Fact Sheet to calculate reasonable attorney fees according to various statutory

fee-shifting provisions.132 The line of cases relying on

126 .

127 at 7.

128 Mot., "Declaration of Christopher Benoit," ECF No. 56-1, Ex. 1.

129 Mot., "Declaration of Lynn Coyle Pursuant to ." ECF No. 56-1, Ex. 5.

130 Mot., "Declaration of John P. Mobbs," ECF No. 56-1, Ex. 2.

131 Resp. 5. , Resp., "State Bar of Texas 2015 Hourly Fact Sheet" ("Fact Sheet") ECF No. 65-1, Ex. A.

132 [*31]

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the Fact Sheet is unpersuasive. First, the Texas Bar has not published an updated Fact Sheet since 2015. Five-year-old fee data is unreliable and likely to skew lower than current attorney fees. The Fact sheet itself notes a

7.4 increase in median rates from 2013 to 2015.133

Second, it is uncertain that even a 2021 Fact Sheet would accurately represent the reasonable hourly rate for the El Paso legal community. DMRS included with its motion a Review of the State Bar of Texas

by Statistician N. Shirlene Pearson, Ph.D.

("Dr. Pearson").134 Dr. Pearson stated the Texas Bar

survey underlying the Fact Sheet data suffered from the fatal defects of a limited sample size, selection bias, and

suboptimal methodology.135 Moreover, the hourly rates

listed on the Fact Sheet do not distinguish between reported billing method: hourly fees, flat rates, contingency fees, or discounted fees for volume

clients.136 Dr. Pearson concluded the Fact Sheet does

not reliably reflect the hourly rates of attorneys in

Texas.137 Tellingly, the Texas Bar itself warns against

using the Fact Sheet to set attorney fees.138

.

133 Fact Sheet 4.

134 Mot. "Review of the State Bar of Texas report and its Use by the Texas Judiciary in

Deciding Plaintiff Attorney Hourly Fees in Labor-Employment Cases" ("Review of Fact Sheet") ECF No. 56-1, Ex. 1-C.

135

136 Fact Sheet. Review of Fact Sheet 5.

137 Review of Fact Sheet 6.

138 Texas State Bar, Demographic & Economic Trends: Economic Trends, available at https://www.texasbar.com/AM/Template.cfm Section Demogr

Finally, the Fifth Circuit has not adopted the Fact Sheet as a determinative measure of reasonable attorney fees in a given community. Instead, Fifth Circuit jurisprudence is based on trial court reliance on attorney

affidavits.139 ICE does not dispute the unreliability of the

Fact Sheet [*32] or offer its own attorney affidavits. Instead, it merely points to non-binding law and argues the court should blindly follow it. After consideration of the significant limitations of the Fact Sheet, this court relies on the three attorney declarations supporting the Motion, which compellingly concur that the requested rate is reasonable.

The large amount of work done in such a low number of hours is the direct result of Benoit's high level of litigation skills and accompanying effectiveness. Given the delays and conduct of ICE in this case, a less experienced attorney would have easily spent a substantially higher number of hours. By way of illustration, 190 compensable hours at 275 would yield a total of 52,250 in attorney fees—more than Benoit requested. ICE's objection to the proposed hourly rate is solely based on a much-discredited study and not on Fifth Circuit jurisprudence. To follow ICE's rationale would simply discourage highly skilled attorneys like Benoit from taking on difficult cases like this one. DMRS has met its burden to show the reasonableness of its requested fee.

Considering the applicable law and pertinent facts before this court, an hourly rate of 375 will [*33] be applied to calculate the lodestar. After multiplying this rate by the 138.5 compensable hours, reasonable attorney fees in this case are 51,937.50.

aphic and Economic Trends (last accessed Jan. 20, 2021).

139

.

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of 17

Pursuant to , a judge may include costs for fees of the clerk of court and service of summons of subpoena in a judgment upon filing of a bill of costs. In its bill of costs, DMRS requests such

reimbursement in the amount of 432.20.140 ICE does

not challenge these costs.141 After due consideration,

the court finds it in the interest of justice to grant DMRS's bill of costs.

Accordingly, the court enters the following orders:

1. that "Plaintiff'sOpposed Application for Attorney Fees and Costs"[ECF No. 56] is .

2. that PlaintiffDiocesan Migrant & Refugee Services shall

from Defendant United StatesImmigration and Customs Enforcement for work performed in this case.

3. that PlaintiffDiocesan Migrant & Refugee Services shall

from Defendant United StatesImmigration and Customs Enforcement costs of thecourt in the amount of .

this day of .

/s/ Frank Montalvo

[*34]

140 "Bill of Costs" 1, ECF No. 55, filed Nov. 2, 2020.

141 Resp. 1 fn. 1.

App000617


CitedAs of: December 7, 2021 4:44 AM Z

United States District Court for the District of Columbia

September 3, 2018, Decided; September 3, 2018, Filed

Civil Action No. 16-cv-1790 (DLF)

2018 U.S. Dist. LEXIS 233651 *

THOMAS J. COLBERT, Plaintiff, v. FEDERAL BUREAU OF INVESTIGATION, et al., Defendants.

requests, records, discovery, privacy interest, processing, public interest, disclosure, pages

[*1] For THOMAS J. COLBERT, TJC Consulting, LLC, Plaintiff: Mark Steven Zaid, LEAD ATTORNEY, Bradley Prescott Moss, LAW OFFICES OF MARK S. ZAID, P.C., Washington, DC.

For FEDERAL BUREAU OF INVESTIGATION, DEPARTMENT OF JUSTICE, Defendants: Jeremy S. Simon, LEAD ATTORNEY, U.S. ATTORNEY'S OFFICE FOR THE DISTRICT OF COLUMBIA, Washington, DC.

ROBERT RACKSTRAW, Movant, Pro se, Coronado, CA.

DABNEY L. FRIEDRICH, United States District Judge.

DABNEY L. FRIEDRICH

On September 8, 2016, the plaintiff, Thomas J. Colbert, filed a complaint to compel the FBI to disclose the investigative file of the D.B. Cooper skyjacking incident. Colbert believes that the FBI bungled the investigation and allowed the alleged perpetrator, Robert Rackstraw, to escape justice. Although the FBI has not yet completed the processing of approximately 71,000 pages of potentially responsive records, Colbert filed a Motion for Partial Summary Judgment or Alternatively Discovery. Dkt. 21. Colbert asks the Court to determine whether the FBI is entitled to withhold any information

under FOIA exemptions 6 and 7(C).1

, Alternatively, Colbert asks the Court to grant his request for discovery. For the reasons [*2] discussed below, the Court will deny Colbert's motion.

Under exemption 7(C), an agency may "withhold 'investigatory records compiled for law enforcement purposes, or information which if written would be contained in such records, but only to the extent that the production of such records or information would

1 Exemptions 6 and 7(C) protect information that would invade the privacy of third parties. Because Exemption 7(C) provides a lower bar for the agency to meet in that it requires the agency to show an "unwarranted"—as opposed to "clearly unwarranted"—invasion of personal privacy, this opinion only addresses whether the FBI has met its burden under Exemption 7(C).

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of 4

constitute an unwarranted invasion of personal privacy.'"

(internal quotation marks omitted);

. Once an agency has shown that the disclosure of certain records would implicate privacy concerns, a FOIA requester can still obtain the records if the requester can show that the public interest in disclosing the records outweighs the privacy interests at stake. To satisfy this burden, a FOIA requester must show that (1) the public interest sought to be advanced is a significant one, an interest more specific than having the information for its own sake, and (2) the information is likely to advance that interest."

(internal quotation marks omitted). That"balancing test must be applied to the specific facts of each case."

. And it is possible that a "particular record may be protected in one set of circumstances, but not in others." When the claimed public interest [*3] "is government wrongdoing, then the requester must produce evidence that would warrant a belief by a reasonable person that the alleged Government impropriety might have occurred."

(internal quotation marks omitted).

Here, Colbert argues that the FBI mishandled the D.B. Cooper case, and the public therefore has an interest in knowing the path that the investigation took. Pl.'s Mot. at 20-21, Dkt. 21. The FBI disputes Colbert'scharacterization of the investigation and asserts thatRackstraw has a substantial privacy interest in not beingassociated with criminal activity. Def.'s Opp'n at 4-5,Dkt. 25. At this stage, however, the FBI does not arguethat Rackstraw's privacy interest outweighsthe public interest in disclosure of the requestedrecords. Rather, the FBI contends that it should beafforded the opportunity to balance the competing

interests as it processes Colbert's request. Third Hardy Declaration 13, Dkt. 25.

The D.C. Circuit has "long recognized" that "the mention of an individual's name in a law enforcement file will engender comment and speculation and carries a stigmatizing connotation."

. Thus, the D.C. Circuit has "held that not only the targets of [*4] law-enforcement investigations, but also witnesses, informants, and . . . investigating agents have a substantial interest in ensuring that that their relationship to the investigations remains secret." (internal quotation marks omitted). Even when the existence of an investigation has been made public, the subject of an investigation retains "a privacy interest . . . in avoiding disclosure of the details of the investigation."

; (congressman retained

privacy interest in the substance of an investigation even though the FBI and congressman publicly acknowledged investigation's existence).

The FBI acknowledges that the agency "followed a lead regarding Rackstraw" in the D.B. Cooper investigation. Def.'s Opp'n at 4, Dkt. 25. But the FBI also represents that it pursued numerous leads during the now closed investigation, Third Hardy Decl. at 13, and ultimately cleared Rackstraw. Def.'s Opp'n at 2, 4. Rackstraw's privacy interest in the substance of the D.B. Cooper investigation thus remains, despite the extensive publicity about him in connection with the

investigation.2

2 Rackstraw was permitted to file an amicus brief in this case. He asserts that he is not D.B. Cooper and makes clear that he does not want the FBI to release any documents to Colbert. Dkt. 30.

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of 4

Balanced against Rackstraw's privacy interest is Colbert's claim that the FBI mishandled the D.B. Cooper [*5] investigation. But Colbert has offered only conclusory allegations that the FBI failed to zealously pursue investigatory leads, and he has provided no evidence to support these allegations. Thus, the Court cannot conclude that the public interest in the disclosure of records related to the D.B. Cooper investigation categorically outweighs Rackstraw's substantial privacy interest in not having the records released to the public. Consistent with other FOIA cases, the Court will assess the appropriateness of any claimed withholdings after the FBI has processed the requested records and

asserted exemptions.3

Colbert also requests discovery in three areas. First, Colbert requests discovery to determine that Rackstraw was investigated as a suspect in the D.B. Cooper case. The FBI has conceded that fact, so discovery is not warranted on this basis. Second, Colbert requests discovery to determine whether the FBI authorized the disclosure of official investigative files, but the FBI has confirmed that any release of FBI records was unauthorized. Third Hardy Declaration 11, Dkt. 25. But Colbert has not offered evidence of bad faith, therefore, discovery is not justified.

. Finally, Colbert [*6] requests discovery to determine why the FBI disregarded Rackstraw as a suspect. Discovery in FOIA cases is "rare" and "only appropriate when an agency has not taken adequate steps to uncover responsive documents."

, aff'd,

3 For the reasons stated, the Court also rejects Colbert's request for a Vaughn Index which would reveal details about the number and type of documents in which Rackstraw's name appears.

(cited favorably in

. Here, Colbert does not allege that the FBI has not adequately searched for responsive documents. Instead, Colbert seeks to use discovery to shortcut the agency's review and production process. Accordingly, the Court denies Colbert's request for discovery.

Separately, the parties dispute whether 500 pages per month is a reasonable production rate for the approximately 71,000 pages of responsive records. The FBI has explained that the agency's standard policy is to process 500 pages per month for medium and large requests. Hardy Declaration 8, Dkt. 15. The FBI adheres to that policy because it is based on sound FOIA business practice, promotes efficiency, and allows the FBI to maintain proper information security. The policy also allows the FBI to process multiple complex requests simultaneously and meet litigation demands.

14, 15, 16. Colbert requests that the FBI process 3,000 pages per month because at the current processing rate, [*7] it will take the FBI over a decade to process the responsive records. Dkt. 31. Alternatively, Colbert requests limited discovery related to the processing rate. Dkt. 33.

Courts have broad discretion to determine a reasonable processing rate for a FOIA request. Several factors inform the analysis, including the size and compelling need of the request compared to others, as well as the effect of the request on the FBI's ability to review other FOIA requests. ,

;. When

determining the rate at which a federal agency must respond to FOIA requests, courts often give deference to the agency's release policies.

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of 4

, , No. 18-5133 (D.C. Cir. May 2, 2018) (applying DOJ's 500-page interim release policy because the policy would "promote efficient responses to a larger number of requesters" and "the Court sees no basis to expedite release"). At this time, the Court will not order the FBI to adjust its standard processing rate, but it directs the FBI to submit a status report within 90 days updating the Court on its progress responding to Colbert's records request. Thereafter, the Court will schedule a status conference to consider whether the [*8] standard processing rate remains reasonable.

For the foregoing reasons, it is ORDERED that Colbert's motion for summary judgment or in the alternative for discovery is DENIED.

/s/ Dabney L. Friedrich

DABNEY L. FRIEDRICH

United States District Judge

Date: September 3, 2018

App000621


No SignalAs of: November 23, 2021 11:13 PM Z

United States District Court for the District of Columbia

July 8, 2021, Decided; July 8, 2021, Filed

Civil Action No. 1:18-cv-01477 (CJN)

2021 U.S. Dist. LEXIS 205698 *

INSTITUTE FOR JUSTICE, Plaintiff, v. INTERNAL REVENUE SERVICE, et al., Defendants.

REDACTED, records, exempt, structuring, withhold, pages, emails, disclosure, documents, currency, divorce, deliberative process, investigators, predecisional, cases, deliberative, interview, identification, guidelines, processing, petitions, agencies, deposits, Partial, productions, withheld, privacy, talking

[*1] For Internal Revenue Service, Defendant: Catriona M. Coppler, U.S. DEPARTMENT OF JUSTICE, Washington, DC; Kristina Marie Portner, LEAD ATTORNEY, TAX, Washington, DC; Ryan O'Connor McMonagle, LEAD ATTORNEY, U.S. DEPARTMENT OF JUSTICE, Washington, DC.

For Institute for Justice, Plaintiff: Ryan S. Baasch, TEXAS OFFICE OF THE ATTORNEY GENERAL, Austin, TX; Andrew D. Prins, LATHAM & WATKINS LLP, Washington, DC.

For Department of Justice, Defendant: John Moustakas, LEAD ATTORNEY, U.S. ATTORNEY'S OFFICE FOR THE DISTRICT OF COLUMBIA, Washington, DC.

CARL J. NICHOLS, United States District Judge.

CARL J. NICHOLS

This case involves a series of Freedom of Information Act ("FOIA") requests about a controversial form of civil asset forfeiture carried out by the Internal Revenue Service. The IRS has processed tens of thousands of pages, but tens of thousands remain, and the Institute for Justice (the requester, "IJ") now challenges the scope of the IRS's redactions under several FOIA exemptions. Before the Court are the Parties' Motions for Partial Summary Judgment, which the Court determined would promote the resolution of this litigation. ECF Nos. 49, 50. For the reasons below, the Court will grant in part and deny in [*2] part each Party's respective motion.

In 2016, IJ lodged a FOIA request to secure information about how the IRS enforces its structuring laws. Structuring laws help the IRS detect money laundering by prohibiting individuals from avoiding financial reporting requirements under the

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of 10

. . Under the Act, banks must file with regulators currency transaction reports, which list all transactions over 10,000. .Structuring laws support the Act by prohibiting individuals from "breaking down . . . a single sum of currency exceeding 10,000 into small sums,"

, "for the purpose of evading reportingrequirements." .

While structuring laws are designed to "detect[] and deter[] [underlying] criminal behavior" (like fraud or money laundering), a 2017 investigation by the Treasury Inspector General for Tax Administration found that the IRS "largely pursued [structuring] cases against legal source funds from business accounts," not against suspected "criminal enterprises." Treasury Inspector Gen. Tax Admin.,

Businesses, Ref. No. 2017-30-025, at 2-3 (Mar. 30, [*3] 2017), ECF No. 50-8 ("TIGTA Report"). The practice of seizing money from legal businesses that happen to make large cash deposits led to widespread criticism.

(Thomas, J., concurring in denial of cert.) ("[B]ecause the law enforcement entity responsible for seizing the property often keeps it, these entities have strong incentives to pursue forfeiture."). And in the wake of the Inspector General's investigation, the IRS pledged that it would "no longer pursue the seizure and forfeiture of funds associated solely with 'legal source' structuring cases unless there are exceptional circumstances." TIGTA Report at 3.

IJ submitted FOIA requests seeking records relating to that pledge, and over the last 26 months the IRS has produced approximately 26,000 pages of records, withholding or redacting certain records under various FOIA Exemptions. Pl.'s Partial Cross-Mot. Summ.

J. 1-3, ECF No. 50 ("Pl.'s Mot."). Although the IRS'sproduction continues, on January 15, 2020, the Courtdetermined that a decision regarding theappropriateness of certain categories of withholdingswould promote the resolution of this litigation. Minute Order Jan. 15, 2020. In particular, IJ [*4]now challenges the IRS's decision to either fully orsignificantly redact three categories of records: (1)policy documents describing the agency's approach tolegal-source structuring cases; (2) agency-leveldocuments about how the IRS considers petitions forremission or mitigation filed by individuals "seeking thereturn of money seized under the structuring laws;" and(3) the case files and decision letters the IRS compliedfor a number of individuals who filed petitions to get theirmoney back. Pl.'s Mot. at 10-11. Following briefing onthe Parties' Motions for Partial Summary Judgment, theCourt directed the agency to submit a representativesample of those disputed records under seal. Minute Order Jan. 26, 2021. After reviewing thoserecords , the Court heard oral argument. Minute Order Feb. 18, 2021.

FOIA "generally require[es] federal agencies to make their records available to the public upon request."

. An agency may redact or withhold information covered by one of the exemptions listed in . If a plaintiff objects, "the agency has the burden of showing that [the] requested information comes within a FOIA exemption."

(citation [*5] omitted). To do so, an agency must "describe the justifications for nondisclosure with reasonably specific detail, demonstrate that the

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information withheld logically falls within the claimed exemption,"

(citation omitted), and "reveal as much detail as possible" about "the nature of the document, without actually disclosing information that deserves protection."

. The Court must then decide "whether [the agency's] non-disclosure was permissible."

.

Most of the Parties' current dispute turns on FOIA's privacy exemptions. Those exemptions let agencies redact "names and identifying information" from "personnel and medical files" (Exemption 6) and "law enforcement" records ( ) to prevent "unwarranted invasion[s] of personal privacy."

& . IJ argues that the IRS hasimpermissibly redacted interview notes that cannot be

used to identify any individual. Pl.'s Mot. at 13-19.1

Those notes memorialized interviews between IRS TaskForce Officers and bank employees and became part ofthe case files the IRS compiled on individuals whoattempted to recover their assets. at 14. The IRS

1 IJ concedes, as it must, that the government may redact information that can plausibly lead to the identification of individuals discussed in those interviews, like "names, addresses, social security numbers, birth dates, or bank account numbers." Pl.'s Mot. at 14 (citing

).

largely sidesteps IJ's identification principle, focusing instead on its [*6] perceived obligation to redact any non-public information that is personal in nature.

, Defs.' Opp'n & Reply 4, 7-8, ECF No. 53 ("Defs.' Opp'n"). IJ has the better argument.

Identification is the touchstone of FOIA's privacy exemptions. The Supreme Court has held that

"cover[s] detailed Government records on an individual which can be identified as applying to that individual."

(citation omitted). sweeps more broadly, covering traditional examples of personally-identifiable information like "names, addresses, [and] dates of birth," as well as information whose "mosaic effect" may "lead to the identification" of "third parties."

(comparing cases).2 But neither

exemption authorizes agencies to withhold information that (either on its own or in combination with other disclosed information) cannot reasonably be used to identify a specific individual.

(agencies may not redact "all of the material in" a responsive record "solely on the grounds that the record includes some information which identifies a private citizen or provides that person's name and address"). Courts thus regularly require agencies to disclose information that some may deem personal, so long as strategic [*7] redactions are used to stop readers from linking those records to any particular person.

2 When an agency justifies its redactions under both and , "the Court need only

address whether the agency has properly withheld . . . documents under" the lower bar, " ."

.

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of 10

(summaries of Air Force Academy disciplinary proceedings released "with personal references . . . deleted");

(interviews between immigration officers and deported non-citizens released after redacting all names);

(released records listing prescription medications taken by unnamed members of Congress);

(immigration "case history" descriptions released without "personally identifying information");

(Title IX investigation letters released, which had language "too general to allow for identification of individuals involved").

In each case, the key question is not whether the "investigative details" described in an agency's records touch on personal matters in the abstract, but whether those details "would reveal the identity or otherwise implicate the privacy interests of any third party."

. When an agency finds material likely to reveal the identity of a third party, it must redact that "specific information" and release the rest.

;

. And to ensure that it does so, the agency must "provide[ ] a detailed justification and not just conclusory statements to demonstrate that all reasonably [*8] segregable information has been released."

(citation omitted).

Here, the IRS has failed to show that it redacted no more than the information necessary to prevent readers

from identifying third parties. For example, the IRS justifies its decision to fully redact 389 pages and partially redact another 785 documents with this: "[the following] information can be identified as applying to the petitioner(s) whose property was subject to seizure."

Decl. of William M. Rowe 42-47, ECF No. 49-1 ("Rowe Decl."). But the IRS does not limit its focus to personally identifiable information. Instead, it withholds all information that it considers personal, like "financial records, criminal investigation history, driving history, child support obligations, and other personal factual information about petitioners' cases and backgrounds." Defs.' Opp'n at 7. The IRS has made essentially no effort to show that, once all personal identifiers are removed, the remaining information would lead readers to identify a particular person.

Of course, if the generic description of a crime is paired with a person's name or the date and location of an arrest, then the information (in combination) likely [*9] would identify a particular person. But the Court struggles to see how after names, dates, and locations are removed, readers could tie any one of the three-hundred-and-thirty million people in this Country to a general description of criminal history. The same is true of driving history, business history, or an anonymous history of divorce and child support obligations. Once all names, dates, times, locations, and traceable numbers are redacted, it is difficult to see how readers could link most of the information the IRS chose to redact to any specific person.

Consider the following hypothetical. Say the agency is about to redact the summary of an interview between IRS investigators and a person suspected of unlawfully structuring bank deposits. The summary might look like this:

Cathy Ames said she served in the Air Force for ten years, and she had been retired since 2004. Since

App000625


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her retirement, she has been working as a certified schoolteacher and teaches ballet lessons on the side. Ames said her divorce started in 2010 and was finalized in 2011. Before her divorce, she was married to Adam Trask for three years and has two sons from that marriage. Ames stated to investigators Sherlock [*10] and Holmes that she took 150,000 out of her bank account in 2009 because her marriage had started to sour, and she knew it would end in divorce. Ames stated that after the divorce, she began depositing the money into a new account with the Security Service Federal Credit Union in 9,999.00 increments to avoid filling out paperwork with the Credit Union. Investigators Sherlock and Holmes asked if Ames knew that she wasn't supposed to make small deposits to avoid reporting large transactions. Ames said she knew it wasn't right. But as she had served her country and earned the money, she thought she could do whatever she wanted with it. The investigators thanked Ames for coming to talk this matter through. And then ended the conversation with Ames and walked her to the door.

In this hypothetical interview, it is easy to see how the various names, dates, and account information might lead readers to identify the people involved. But the appropriate remedy is to redact those exempt pieces of information and release everything else.

;

. Indeed, FOIA does not "permit[] an agency to exempt from disclosure all of the material in an investigatory record solely on the grounds that the [*11] record includes some information which identifies a private citizen." Now consider the same interview with obvious identifiers removed:

[TEXT REDACTED BY THE COURT] said she

served in the [TEXT REDACTED BY THE COURT] for ten years, and she had been retired since [TEXT REDACTED BY THE COURT]. Since her retirement, she has been working as a certified schoolteacher [TEXT REDACTED BY THE COURT] lessons on the side. [TEXT REDACTED BY THE COURT] said her divorce started in [TEXT REDACTED BY THE COURT] and was finalized in [TEXT REDACTED BY THE COURT]. Before her divorce, she was married to [TEXT REDACTED BY THE COURT] for three years and has [TEXT REDACTED BY THE COURT] from that marriage. [TEXT REDACTED BY THE COURT] stated to investigators [TEXT REDACTED BY THE COURT] that she took [TEXT REDACTED BY THE COURT] out of her bank account in [TEXT REDACTED BY THE COURT] because her marriage had started to sour, and she knew it would end in divorce. [TEXT REDACTED BY THE COURT] stated that after the divorce, she began depositing the money into a new account with the [TEXT REDACTED BY THE COURT] Credit Union in 9,999.00 increments to avoid filling out paperwork with the Credit Union. Investigators [*12] [TEXT REDACTED BY THE COURT] asked if [TEXT REDACTED BY THE COURT] knew that she wasn't supposed to make small deposits to avoid reporting large transactions. [TEXT REDACTED BY THE COURT] said she knew it wasn't right. But as she had [TEXT REDACTED BY THE COURT] earned the money, she thought she could do whatever she wanted with it. The investigators thanked [TEXT REDACTED BY THE COURT] for coming to talk this matter through. And then ended the conversation with [TEXT REDACTED BY THE COURT] and walked her to the door.

Once names, dates, and obvious identifiers are removed, thousands, if not millions, of people potentially

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fit the profile of this interviewee. But in the Court's review of the disputed records, it was apparent

that the IRS has redacted nearly every word of similar interviews, rather than strategically withholding identifying information and disclosing the rest. And by redacting information "too general to allow for identification of individuals involved," it overstepped its authority under FOIA.

.

As the IRS reassesses its productions in light of this decision, the Court expects it to change course and limit its redactions to information likely to trigger [*13] the

identification of a particular individual.3 Should the IRS

opt to redact more than personally identifiable information, it bears the burden of articulating the logical path a reader might take to link those additional pieces of information to a specific person,

, so it can show that it has released all "reasonably

3 While the agency must adjust its redaction practices, it is not required to (as IJ requests) create anonymous identifiers for the officers or agents listed in its records. FOIA "does not obligate agencies to create or retain documents; it only obligates them to provide access to those which it in fact has created and retained."

. Here, the case files IJ seeks do notcontain anonymous identifying numbers for agencyinvestigators. The IRS would have to create them. To supportits request, IJ cites

Pl.'s Mot. at 23 n.10 (citing ). But in , the agency tried to

withhold witness identification numbers that were already inthe disputed records. The agency was not asked to createthem from scratch. ;

("[I]nsofar as the order of the court below requires the agency to create explanatory material, it is baseless.").'

segregable" portions of records that contain some

exempt material, .4 If the agency fails

to prove that it has released all non-exempt material not "inextricably intertwined with" exempt material, then IJ may seek further relief at a later stage in this litigation.

.

IJ also challenges the IRS's decision to withhold forty pages in full and eleven pages in part under the deliberative process privilege. Pl.'s Mot. at 21-23 (discussing ). The privilege exempts documents that are "predecisional" and "deliberative."

. Adocument is predecisional when it contributes to "an agency decision or policy,"

, and it is deliberative when it "reflect[s] an agency's preliminary positions or ruminations about how to exercise discretion on some policy matter" or "policy-implicating judgment," [*14]

.Assessing the "predecisional" and "deliberative" dimensions of an agency record helps courts answer the "key question" behind the deliberative process exemption: "whether disclosure would tend to diminish

4 As the IRS has yet to show that releasing information that cannot be linked to any particular person implicates a privacy interest under or , the Court does not have occasion to balance the public's interest in learning more about how the IRS processes petitions to recover seized assets against any protected privacy interest.

.

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candor within an agency." (citing

).

The Court does not doubt that compelling the release of the documents withheld under the deliberative process privilege would diminish candor within the IRS. Consider each of the three types of records disputed here: First, emails exchanged between an IRS special agent and other IRS officials discussing talking points about "legislative proposals to codify certain policy changes made by the Service in structuring cases." Rowe Decl. 33(b). Second, a draft version of the Treasury Inspector General for Tax Administration ("TIGTA") Report entitled "Fiscal Year 2016 Review of Compliance with Legal Guidelines When Conducting Seizures of Taxpayers' Property." And, third, a draft letter to a congressman about how the IRS reviews petitions for remission or mitigation of seized assets and an email accompanying that letter.

Turning first to the emails about talking points. To demonstrate that the emails are predecisional, the IRS must "identify [*15] a decisionmaking process to which the document contributed."

. IJ argues that the IRS is using the deliberative process privilege to shield Congress's legislative process. Pl.'s Reply Support Partial Cross-Mot. for Summ. J. 14 n.6, ECF No. 55 ("Pl.'s Reply"). The Court is not convinced.

Each email contains an agency employee's thoughts about what should and should not appear in a final set of talking points about several legislative proposals. Rowe Decl. 33(b); Tr. of Hr'g (forthcoming). An employee's thoughts about what the agency's position should be are not themselves a final statement of the agency's position.

(noting that the agency need only describe "what deliberative process is involved, and the role played by the documents at issue in the course of that process"). In doctrinal terms, the emails are predecisional because they were part of the agency's process to develop its "opinions with respect to legislative proposals" and deliberative because the emails reflect the agency's ruminations about what policy stance it should adopt toward those proposals. Rowe Decl. 33(b). The IRS was thus entitled to withhold those emails.

The draft TIGTA Report was similarly "predecisional," [*16] as the draft was part of the deliberative process that led to the final report. Rowe Decl. 33(a)(3);

("A document is 'predecisional' if it precedes, in temporal sequence, the 'decision' to which it relates." (internal quotations and citations omitted)). IJ nevertheless contends that the IRS has failed to demonstrate that the draft report is deliberative because it does not reveal any "exercise of agency policy-oriented judgement." Pl.'s Reply 16, ECF No. 55 (quoting ). Not so.

The draft report revealed "opinions" and "recommendations" about what facts the final report should contain. Rowe Decl. 33(a)(3). And the act of "culling out relevant" facts involves a deliberative "judgmental process which could be compromised by disclosure." & n.6 (discussing

);

(holding documentsexempt because disclosure would reveal agency'sevaluation of its preferred facts). The IRS has thusappropriately justified its decision to withhold the draftTIGTA Report. As for the draft letter to a congressman

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and an email about that letter, IJ concedes that the records are predecisional, as they led to a final letter. Pl.s' Mot. at 23-24. But it contends that neither record is likely [*17] deliberative because the final letter (which IJ has already received) contains only "factual material."

at 23. The IRS responds by stressing that those records reflect the agency's internal "advisory opinions, recommendations and deliberations" about how to respond to a congressional inquiry. Defs.' Opp'n at 20 (quoting ).

The agency's internal deliberations about whether and how to respond to a congressman involve discretionary, policy-oriented judgment calls about which facts are responsive and most appropriate to disclose to another branch of government.

& n.6. Moreover, the IRS has represented that its employees will be less likely to respond candidly and creatively when invited to comment on agency responses to congressional inquiries if their internal advisory opinions and drafts are subject to disclosure.

Tr. of Hr'g (forthcoming). Enabling and encouraging candor among agency actors is, of course, the primary objective of the deliberative process privilege.

. The IRS has appropriately withheld the draft congressional letter and accompanying email.

The Parties' dispute over records withheld under the is largely semantic. Under

, the IRS is empowered to withhold [*18] records that are "specifically exempted from disclosure by statute." And the Act specifically exempts currency transaction "reports and records of reports" from disclosure. . That exemption shields the information in currency transaction reports, even if

the information is quoted in other agency documents. .

IJ quibbles with the IRS's decision to withhold "references" to currency transaction reports in its internal memoranda. Pl.'s Mot. at 24-25. To be sure, "references" might include something other than information taken directly from a currency transaction report.

("[D]ocuments that involve [currency transaction] reports or records of reports . . . are not, strictly speaking, the same thing as actual reports or records of reports."). But the IRS has represented that it used the word "references" to refer to information taken directly from currency transaction reports, see Tr. of Hr'g (forthcoming), and the agency is entitled to the presumption that it made that representation in good faith,

. The Court thusconcludes that the IRS has withheld information directlyextracted or taken from currency transaction reports,and therefore its withholdings are permissible under

and the [*19] ..

IJ argues that the IRS is redacting too much information under as well. shields records that "would disclose guidelines for law enforcement investigations or prosecutions if such disclosure could reasonably be expected to risk circumvention of the law." . The documents need not be made during an ongoing criminal investigation, but they must describe administrative or operational guidelines which, if disclosed, would help criminals circumvent the law.

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.

Here, the IRS redacted portions of a document that describes "guidelines and steps for processing [petitions for remission or mitigation] as well as guidance in corroborating the information submitted by the petitioner." Defs.' Reply 19, ECF No. 54 (discussing IFJ 0018-000500). The IRS says that disclosing those guidelines would enable "individuals seeking to circumvent structuring laws to operate in a manner that would avoid detection of their criminal activity." Rowe Decl. 48(a). The guidelines "describ[e] specific investigative techniques to be employed by Special Agents in structuring cases" and would "reveal the scope of investigative activity" so that disclosure would, at a minimum, help criminals [*20] avoid seizure by (as IJ acknowledges) concealing their identities. ;

Pl.'s Reply 22. By identifying the specific laws (structuring laws) "that would be easier to violate if the information were released," as well as the way in which those laws would be easier to exploit, the IRS has adequately justified its withholdings under

..

Finally, the Parties dispute the appropriate monthly production rate. Over two years ago, Judge Kollar-Kotelly noted that it would be inappropriate for productions to extend over multiple years. Minute Order May 29, 2019. Nevertheless, productions drag on. At the present rate, the IRS will not finish producing records for several years. Joint Status Report (April 30, 2020), ECF No. 52.

The IRS has been processing 1,000 pages per month

for over a year-and-a-half. Decl. of Elizabeth Hill 23, 43-47, ECF No. 36-1. During the intervening time, the IRS's FOIA caseload has dropped from 60 to 49 cases and the agency has added six additional attorneys to review that smaller caseload. Supp. Decl. of Jamie Song Decl. 13. The IRS has confirmed that all the remaining records are case files and decision letters related [*21] to individual petitions for remission or mitigation. Tr. of Hr'g (forthcoming). And this Opinion affords the agency direct guidance about how

to process those remaining petitions.5 The Court is thus

not persuaded that the IRS has submitted sufficiently "clear, specific, and reasonably detailed" justifications for continuing to process no more than 1,000 pages per month.

.

Courts regularly direct agencies to process records at far higher rates than what the IRS has been held to here.

(ordering the majority of 7,500 pages to be processed within thirty-two days);

(5,000 pages per month). And as the IRS's resources to process FOIA requests have substantially improved since the Court first granted its request to limit productions to 1,000 pages per month, the Court believes it is appropriate to require the IRS to now process 3,000 pages per month. After three months of

5 As this Opinion provides specific guidance about the appropriate application of , 5, 6(b), 7(C), and 7(E), the Court will not at this time order the IRS to refrain from using any particular exemption to withhold information in future productions. The Court trusts that the agency will exercise good faith and comply with the Court's directives. But IJ is welcome to press for further review if the agency deviates from the Court's guidance. Pl.'s Reply at 23-24.

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processing records at that higher pace, the IRS may submit a status report detailing the consequences of complying with its new production rate. At that point, the Court will reevaluate the agency's production schedule and decide whether any adjustment is warranted.

For the foregoing [*22] reasons, the Parties' Motions for Summary Judgment, ECF Nos. 49, 50, are granted in part and denied in part. An appropriate order will be entered contemporaneously with this Memorandum Opinion.

DATE: July 8, 2021

/s/ Carl J. Nichols

CARL J. NICHOLS


For the reasons stated in the accompanying Memorandum Opinion, ECF No. 58, it is hereby

that the Parties' Motions for Partial Summary Judgment, ECF Nos. 49, 50, are

and ; it is further

that Defendants reassess previous and ongoing productions in light of this decision; it is further

that Defendants shall process a minimum of 3,000 pages per month, and, after three months of processing records at that pace, Defendants may submit a status report detailing the consequences of complying with that production rate.

DATE: July 8, 2021

/s/ Carl J. Nichols

CARL J. NICHOLS


App000631


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