industry collaboration & interactions with health professionals -- can conflicts of
DESCRIPTION
FDA REGULATORY & COMPLIANCE SYMPOSIUM August 22, 2007. Industry Collaboration & Interactions With Health Professionals -- Can Conflicts of Interest be Properly Managed? Tom Stossel. Brigham & Women’s Hospital. Harvard Medical School. - PowerPoint PPT PresentationTRANSCRIPT
Industry Collaboration & Interactions With Health Professionals -- Can Conflicts of Interest be Properly Managed?
Tom Stossel Brigham & Women’s Hospital
Harvard Medical School
FDA REGULATORY & COMPLIANCE SYMPOSIUMAugust 22, 2007
Results of Biomedical R & D Spending
40
20
30
10
1970 1980 1990 2000
$ Billion
Heart AttackDeaths per 100K Population
400
200
300
100
Pharma
NIH CardiovascularDisease Mortality
1970 1980 1990
400
200
300
100
2000
400
200
300
Papers / Year Concerning Conflict$ of Interest
EXPLOSIVE EMERGENCE OF COI$
Heart AttackDeaths per 100K Population
NIHConsulting Ban
Tseng case
Dong caseOlivieri case
Gelsinger case
Harvard Regulations
Publishing
UBIQUITY OF CONFLICT OF INTEREST$ MAKES FOR A SLIPPERY OPPONENT
Productmarketing
PracticeGuidelines
Conflict of Interest$
Sponsored Research
Advisory Work
CME
PharmacyInformation
Startups
Editorializing & ReviewingTechnology
Licensing
Clinical Trials
Consulting
THE CASE FOR CONFLICT$ OF INTEREST
Commerce and entrepreneurial activity are important for medical advances.
Practically every interaction between businesses and doctors (physicians and medical researchers) is or is “potentially” corrupt.
Therefore these interactions must be heavily disclosed, regulated and even prohibited.
BUT
WHAT THE COI CASE HAS ACHIEVED
Prophylactic (unenforceable) laws against:
Editorials, reviews, authorship;
Consulting, advising, research grants,ownership (equity).
Reward Controls (“de minimis” limits).
Pharma reps, gifts, meals, samples increasingly banned from academic health centers.
Reduced support for and total amount of CME
Great Lakes AMA CME Conference, Oct. 2006, Cleveland, OH;
Boston University Medical Center, April, 2007.
WHAT THE COI CASE HAS ACHIEVED
Intramural NIH researchers: recruitment & retention problems; unavailable to companies.
WHAT THE COI CASE HAS ACHIEVED
PRELIMINARY POLL RESULTS
COI rules Licensing Sponsored Startupshave had: Technology Basic Clinical
Research (6069) (2108) (1242) (506)
No effect 81% 77% 64% 64%
Delayed 18% 20% 20% 33%
Prevented 1% 3% 16% 3%
WHAT THE COI CASE HAS ACHIEVED
THE CASE FOR CONFLICT$ OF INTEREST: EXPLICIT OR IMPLICIT ASSUMPTIONS
Corporate research is flawed & fraudulent.
Corporate research is biased.
Conflict of interest (or appearance of conflict of interest) erodes trust &
professionalism.
Corporate marketing is not evidence based and hurts patient care.
Claims that commercial interactions with academic medical centers have increased: endangerment of research subjects, research bias, interference with academic freedom, corruption of academic values, violation of scientific norms, dereliction of academic obligations, degradation of research quality, loss of public trustare simply not true --
353 : 1060, 2005
THE CASE FOR CONFLICT OF INTEREST$ Advertising / promotion is not “evidence-based.”
“practicing medicine in the best interest of my patients and on the best available evidence rather than on the basis of advertising or promotion.”
“Pharmaceutical marketing has raised persistent ethical and legal issues about conflict of interest.” Brennan & Mello, JAMA 297 : 1255, 2007
THE BOGUS CASE FOR CONFLICT OF INTERESTS
“The current influence of market incentives in the USA is posing extraordinary challenges to medical professionalism. Physicians’ commitment to altruism, putting the interests of patients first, scientific integrity, and an absence of bias in medical decision making now regularly come up against financial conflicts of interest”
JAMA 295 : 429, 2006
Hippocrates
“To be clear, for-profit industries do not share the same ethical norms to which physicians and other health care professionals must adhere. Their primary commitment is to create shareholder value, not maintain an altruistic commitment to patients.” Brennan & Mello. JAMA 297 : 1255, 2007
PROFESSIONALISM & “ETHICAL NORMS”
EDUCATORS!
DRUG REPS
“Guardian Syndrome” “Commercial Syndrome”
Government, Businesses, Military, Clergy, Medicine, Judiciary, Science.Public Health Officials.
Power, Appearances, Trade, Contracts, Wealth Distribution, Wealth Accrual,Property Seizure. Private Property.
(1916-2006)
1991
MEDICINE & THE APPEARANCE STANDARD
THE EMPIRIC CASE FOR CONFLICT OF INTERESTS Sampling and Gifts Hurt Patients?
“The systematic review of the medical
literature on (industry) gifting by Wazana
found that an overwhelming majority of
interactions had negative results on clinical
care.”
JAMA 295 : 429, 2006
“NO STUDY USED PATIENT OUTCOME MEASURES.”
JAMA 283 : 273, 2000
WHAT WAZANA REALLY SAID:
POSITIVE OUTCOMES NEGATIVE OUTCOMES
Improved ability to Inability to identify identify the treatment wrong claims.for complicatedIllnesses. Formulary requests for no advantage meds.
Fast new drug prescribing
Positive attitude toward drug reps.
WHAT WAZANA REALLY SAID: (JAMA 273 : 373, 2000)
DRUG REPS
RECOMMENDATIONS
Reasonable disclosure.
Flexible oversight; credible punishment.
Gifting & sampling on a discretionary basis
Educate physicians concerning product development & capital markets
STOSSEL DISCLOSURE$FINANCIAL
(CURRENT): Boston Scientific Corp. (Ad hoc consultant); Critical Biologics Corp. (Founder, director, stock, fees);Merck & Co, Inc. (Science Leadership Advisory Board);Zymequest, Inc. (Board of Directors, Scientific & Medical Advisory Boards; consulting fees, stock options, licensed technology);Lectures on conflict of interest (fees).
(PAST): Biogen, Inc. (Scientific Advisory Board, licensed technology, stock options);Dyax, Inc. (Strategic Advisory Board, stock);NeoRx, Inc. (Licensed technology, sponsored research).Gerson-Lehrman Group (Ad hoc consultant);Thousands of free meals, hundreds of pens, etc.
CRIMINAL Jailed for brawling, Mackinac I., Michigan, 1964; escaped.
Harmonies of Interest Enable Giving Back Kasisi & Kondwa Orphanages, Zambia, Dec‘04-‘06
“Options for Children inZambia” (5013c).
Sickle Cell Anemia Clinical Research Center University Teaching Hospital, Lusaka
QuickTime™ and aTIFF (Uncompressed) decompressor
are needed to see this picture.
Further Reading:
Perspectives in Biology & Medicine 50 : 54, 2007Journal of Investigative Dermatology 127 : 1829,
2007
THANK YOU FOR YOUR ATTENTION!