pharmaceuticals conference naag, may 11, 2007 financial conflicts: consequences, proposals jerome p....
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PHARMACEUTICALS CONFERENCE NAAG, MAY 11, 2007
FINANCIAL CONFLICTS: CONSEQUENCES, PROPOSALS
Jerome P. Kassirer, M.D.Distinguished Professor, Tufts University
School of MedicineEditor-in-Chief Emeritus, New England
Journal of Medicine
Assumption:• EVEN SMALL GIFTS INFLUENCE
BEHAVIORPrinciples:• FINANCIAL CONSIDERATIONS NEVER
COMPROMISE MD DECISION-MAKING• MEDICAL INFORMATION FREE OF BIAS
FROM FINANCIAL INDUCEMENTS• PROFESSION ACCOUNTABLE FOR
INORDINATELY HIGH COST OF CARE• ALL FINANCIAL ARRANGEMENTS OPEN
AND TRANSPARENT
Not all incentives are financial…
Nina Easton from Fortune Magazine was asked how she can be objective as a Fox News TV commentator when discussing John McCain’s presidential candidacy, given that her husband is McCain’s media advisor. She replied, “Disclosure is the great disinfectant.”
( NPR, April 1st 2007)
PHYSICIANS’ FERVENT BELIEFS IN THEIR OBJECTIVITY
• TRAINED IN THE SCIENTIFIC METHOD
• RELIGIOUS ADHERENCE TO EVIDENCE-BASED MEDICINE
THE CANDY EXPERIMENT AT CORNELL’S HOTEL SCHOOL
THE GIFT THE TIPNO CANDY ONE PIECETWO PIECESONE PLUS ONE
THE CANDY EXPERIMENT AT CORNELL’S HOTEL SCHOOL
THE GIFT THE TIPNO CANDY 19.0%ONE PIECETWO PIECESONE PLUS ONE
THE CANDY EXPERIMENT AT CORNELL’S HOTEL SCHOOL
THE GIFT THE TIPNO CANDY 19.0%ONE PIECE 19.6%TWO PIECESONE PLUS ONE
THE CANDY EXPERIMENT AT CORNELL’S HOTEL SCHOOL
THE GIFT THE TIPNO CANDY 19.0%ONE PIECE 19.6%TWO PIECES 21.6%ONE PLUS ONE
THE CANDY EXPERIMENT AT CORNELL’S HOTEL SCHOOL
THE GIFT THE TIPNO CANDY 19.0%ONE PIECE 19.6%TWO PIECES 21.6%ONE PLUS ONE 23.0%
COLLEGE LOAN SCANDAL
Financial aid officers: fees based on loan volume, expense-paid trips to exotic locations, stock in company, paid as consultants, advisory board positions.
Students steered to “preferred lists.”
Result: Students and parents ripped off.
THEY CAN INFLUENCE TREATMENT OF MILLIONS
THERAPEUTICS INITIATIVE U.B.C.Statins have not been shown to provide an overall health benefit for primary prevention
NCEP GUIDELINESAggressive LDL lowering for high risk patients (primary prevention) with lifestyle changes (diet, exercise) and statins
NCEP PANEL’S FINANCIAL CONFLICTS(Personal income - honoraria and/or consulting
fees- from all 5 statin companies)
Grundy 5 Hunninghake 4Pasternak 5 Merz 3Stone 5 Smith 0Brewer 4 Cleeman 0Clark 4
FOLLOW-UP OCTOBER 2006
• 2004 NCEP GUIDELINES QUESTIONED• EVIDENCE BASE FOR ORIGINAL
RECOMMENDATIONS WAS WEAK AND BASED ON SECONDARY PREVENTION
• SOME ORIGINAL AUTHORS BACK OFF (NYT)
(Ann. Intern. Med 2006;145:520-530; Lancet 2007;369:168-169)
INTERPRETATION OF CHEST X-RAYS
492 abnormal chest X-rays, according to 30 plaintiff-hired “B” readers (hirees). Films re-read by 6 blinded “B” readers (independents).
(“B” readers are certified by NIOSH; all used standard DHSS form OMB No. 0920-0020)
Gitlin et al Acad. Radiol 2004;11:843-856
RESULTS (%)hirees
independents-------
---------------- Parench. abn. 96 5Pneumocon. 97 6Pleural abn 26 8Film normal 0 38
THEY CAN JEOPARDIZE PATIENT CARE
1997: Rezulin withdrawn from market in England because of liver failure
In U.S., cases of death from liver failure continued to increase
1999: FDA advisory committee voted 11:1 to keep drug on the market. Nearly all members had financial ties to drug maker.
2000: Rezulin withdrawn from market; 63 deaths in U.S. by then.
THEY MAY JEOPARDIZE RESEARCH SUBJECTS
In 1999, 17 year old Jesse Gelsinger died at Penn 4 days into gene therapy experiment
Safety issues of experiment questionableBoth institution and investigator had stake
in company that might profit from resultsInvestigator claimed money was not a factorSome on Penn task force skeptical
THEY MUDDLE INTERPRETATION OF THE OPINIONS OF CONFLICTED EXPERTS
Are they true believers;objective?Subconscious influences: what do
they really believe?Are their actions actually
conscious?
THEY CAN BIAS PRACTICE GUIDELINES
NCEP (NIH, AHA, ACC)ANDROPAUSE (ENDOCRINE
SOCIETY)ALTEPLASE IN ACUTE STROKE (AHA)NKF ON USE OF EPO FOR ANEMIAHEART RHYTHM SOC. ON ICM USESCCM ON XIGRIS, WITH BUNDLING
OTHER RECENT EXAMPLES
Treatment of age-related macular degeneration
Editor of Neuropsychopharmacology publishes ghostwritten paper touting Vagus nerve stimulation
MGH psychiatrists didn’t disclose industry ties in article on drugs in pregnancy
AtriCure procedure at Cleveland Clinic
MAIN POINTS
Industry used educational grants for marketing, especially for off-label uses
Excessive industry influence over content of CME programs
Lack of adequate oversight by ACCME of educational grant programs
THE BROUHAHA OVER LACK OF DISCLOSURE
2003 NEJM, Annals, JAMA
2005 Devices at Cleveland Clinic
2006 JAMA 3 instances
2006 Editor of Neuropsychoparmacology
2007 PHS Guideline on drugs for smoking cessation
DISCLOSURE’S DEFICIENCIES
Disclosure is often incomplete
Difficult to detect bias even when conflict of interest is known
Naming a company may not identify drug named in print or in a lecture
Requires assessing someone’s motives
THEN WHAT IS THE PROBLEM?
The conflict is the real problem, not whether or not it is disclosed.
Pretending that disclosure ‘manages” the conflict doesn’t eliminate the conflict (“necessary but not sufficient”).
(Kassirer JP. A cure for public distrust. Boston Globe, July 27, 2006)
DISCLOSURE’S FLAWS
“It has become a truism onWall Street that conflicts ofinterest are unavoidable. In fact, most of them only seem so, because avoiding them makes it harder to get rich. That’s why full disclosure is so popular: it requires no substantive change.”
Surowiecki J. The talking cure. The New Yorker Dec. 9, 2002
IS THERE A BETTER WAY?
RELY ON UNCONFLICTED EXPERTSINDEPENDENCE AND DIVERSITYEXPERTISE: YES, BUT EXPERTS IN
DATA ANALYSISMINIMIZE CONFLICTED EXPERTSCONFLICTED EXPERTS ALLOWED TO
TESTIFY
THE SLIPPERY
SLOPE
REPRINTS FROM THE REPS PENS AND COFFEE CUPS TEXTBOOKS AND STETHOSCOPES LUNCHES AND PIZZA DINNERS AND TRAVEL CONTINUING MED. EDUCATION SPEAKER’S BUREAUS STOCK AND OPTIONS CONSULTANCIES/MARKETING CONSULTANCIES/SCIENCE JOINT RESEARCH
THE SLIPPERY
SLOPE
REPRINTS FROM THE REPS PENS AND COFFEE CUPS TEXTBOOKS AND STETHOSCOPES LUNCHES AND PIZZA DINNERS AND TRAVEL CONTINUING MED. EDUCATION SPEAKER’S BUREAUS STOCK AND OPTIONS CONSULTANCIES/MARKETING CONSULTANCIES/SCIENCE JOINT RESEARCH
THE SLIPPERY
SLOPE
REPRINTS FROM THE REPS PENS AND COFFEE CUPS TEXTBOOKS AND STETHOSCOPES LUNCHES AND PIZZA DINNERS AND TRAVEL CONTINUING MED. EDUCATION SPEAKER’S BUREAUS STOCK AND OPTIONS CONSULTANCIES/MARKETING CONSULTANCIES/SCIENCE JOINT RESEARCH
THE SLIPPERY
SLOPE
REPRINTS FROM THE REPS PENS AND COFFEE CUPS TEXTBOOKS AND STETHOSCOPES LUNCHES AND PIZZA DINNERS AND TRAVEL CONTINUING MED. EDUCATION SPEAKER’S BUREAUS STOCK AND OPTIONS CONSULTANCIES/MARKETING CONSULTANCIES/SCIENCE JOINT RESEARCH
THE SLIPPERY
SLOPE
REPRINTS FROM THE REPS PENS AND COFFEE CUPS TEXTBOOKS AND STETHOSCOPES LUNCHES AND PIZZA DINNERS AND TRAVEL CONTINUING MED. EDUCATION SPEAKER’S BUREAUS STOCK AND OPTIONS CONSULTANCIES/MARKETING CONSULTANCIES/SCIENCE JOINT RESEARCH
THE SLIPPERY
SLOPE
REPRINTS FROM THE REPS PENS AND COFFEE CUPS TEXTBOOKS AND STETHOSCOPES LUNCHES AND PIZZA DINNERS AND TRAVEL CONTINUING MED. EDUCATION SPEAKER’S BUREAUS STOCK AND OPTIONS CONSULTANCIES/MARKETING CONSULTANCIES/SCIENCE JOINT RESEARCH
THE SLIPPERY
SLOPE
REPRINTS FROM THE REPS PENS AND COFFEE CUPS TEXTBOOKS AND STETHOSCOPES LUNCHES AND PIZZA DINNERS AND TRAVEL CONTINUING MED. EDUCATION SPEAKER’S BUREAUS STOCK AND OPTIONS CONSULTANCIES/MARKETING CONSULTANCIES/SCIENCE JOINT RESEARCH
THE SLIPPERY
SLOPE
REPRINTS FROM THE REPS PENS AND COFFEE CUPS TEXTBOOKS AND STETHOSCOPES LUNCHES AND PIZZA DINNERS AND TRAVEL CONTINUING MED. EDUCATION SPEAKER’S BUREAUS STOCK AND OPTIONS CONSULTANCIES/MARKETING CONSULTANCIES/SCIENCE JOINT RESEARCH
THE SLIPPERY
SLOPE
REPRINTS FROM THE REPS PENS AND COFFEE CUPS TEXTBOOKS AND STETHOSCOPES LUNCHES AND PIZZA DINNERS AND TRAVEL CONTINUING MED. EDUCATION SPEAKER’S BUREAUS STOCK AND OPTIONS CONSULTANCIES/MARKETING CONSULTANCIES/SCIENCE JOINT RESEARCH
THE SLIPPERY
SLOPE
REPRINTS FROM THE REPS PENS AND COFFEE CUPS TEXTBOOKS AND STETHOSCOPES LUNCHES AND PIZZA DINNERS AND TRAVEL CONTINUING MED. EDUCATION SPEAKER’S BUREAUS STOCK AND OPTIONS CONSULTANCIES/MARKETING CONSULTANCIES/SCIENCE JOINT RESEARCH
THE SLIPPERY
SLOPE
REPRINTS FROM THE REPS PENS AND COFFEE CUPS TEXTBOOKS AND STETHOSCOPES LUNCHES AND PIZZA DINNERS AND TRAVEL CONTINUING MED. EDUCATION SPEAKER’S BUREAUS STOCK AND OPTIONS CONSULTANCIES/MARKETING CONSULTANCIES/SCIENCE JOINT RESEARCH