PHARMACEUTICALS CONFERENCE
NAAG, MAY 11, 2007
FINANCIAL CONFLICTS:
CONSEQUENCES, PROPOSALS
Jerome P. Kassirer, M.D.
Distinguished Professor, Tufts University
School of Medicine
Editor-in-Chief Emeritus, New England Journal
of Medicine
Assumption:
• EVEN SMALL GIFTS INFLUENCE
BEHAVIOR
Principles:
• 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)
Not all incentives are financial…
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
NO CANDY
ONE PIECE
TWO PIECES
ONE PLUS ONE
THE TIP
THE CANDY EXPERIMENT AT
CORNELL’S HOTEL SCHOOL
THE GIFT
NO CANDY
ONE PIECE
TWO PIECES
ONE PLUS ONE
THE TIP
19.0%
THE CANDY EXPERIMENT AT
CORNELL’S HOTEL SCHOOL
THE GIFT
NO CANDY
ONE PIECE
TWO PIECES
ONE PLUS ONE
THE TIP
19.0%
19.6%
THE CANDY EXPERIMENT AT
CORNELL’S HOTEL SCHOOL
THE GIFT
NO CANDY
ONE PIECE
TWO PIECES
ONE PLUS ONE
THE TIP
19.0%
19.6%
21.6%
THE CANDY EXPERIMENT AT
CORNELL’S HOTEL SCHOOL
THE GIFT
NO CANDY
ONE PIECE
TWO PIECES
ONE PLUS ONE
THE TIP
19.0%
19.6%
21.6%
23.0%
WHEN FINANCIAL CONFLICTS
TRANSLATE INTO BIAS, WHAT DO
THEY “COST”?
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 GUIDELINES
Aggressive 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
Pasternak
Stone
Brewer
Clark
5
5
5
4
4
Hunninghake
Merz
Smith
Cleeman
4
3
0
0
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)
THEY CAN AFFECT
THE OBJECTIVITY
OF PHYSICIANS
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
5
Pneumocon.
97
6
Pleural abn
26
8
Film normal
0
38
THEY CAN
RAISE THE
COST OF
CARE AND
INCREASE
RISK
WE PAY FOR EXPENSIVE, INEFFECTIVE, AND
RISKY DRUGS
NYT 5/9/07
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 questionable
Both institution and investigator had stake in
company that might profit from results
Investigator claimed money was not a factor
Some 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 ANEMIA
HEART RHYTHM SOC. ON ICM USE
SCCM 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
THEY DENIGRATE PROFESSIONALISM
Cartoons, television (ER, Simpsons)
“EPIDEMIOLOGY”
NEJM
April 26,
2007
Survey of
1662 MDs
(FP, IM, Ped
Card, Anes
Surg)
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
DISCLOSURE:
“THE GREAT DISINFECTANT”
IS DISCLOSURE THE SOLUTION TO
“MANAGING” CONFLICTS OF
INTEREST?
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
DISCLOSURE:
“THE GREAT DISINFECTANT”
LACK OF DISCLOSURE IS NOT
THE PROBLEM
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 on
Wall Street that conflicts of
interest 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 EXPERTS
INDEPENDENCE AND DIVERSITY
EXPERTISE: YES, BUT EXPERTS IN
DATA ANALYSIS
MINIMIZE CONFLICTED EXPERTS
CONFLICTED 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
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