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.
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August 22, 2007
Industry Collaboration & Interactions
With Health Professionals -- Can Conflicts of
Interest be Properly Managed?
Brigham & Women’s
Deaths per 100K
Results of Biomedical R & D Spending
Deaths per 100K
EXPLOSIVE EMERGENCE OF COI$
UBIQUITY OF CONFLICT OF INTEREST$
MAKES FOR A SLIPPERY OPPONENT
Commerce and entrepreneurial activity are
important for medical advances.
Practically every interaction
between businesses and doctors
(physicians and medical
researchers) is or is “potentially”
Therefore these interactions must be heavily
disclosed, regulated and even prohibited.
Prophylactic (unenforceable) laws against:
Editorials, reviews, authorship;
Consulting, advising, research grants,
Reward Controls (“de minimis” limits).
Pharma reps, gifts, meals, samples
increasingly banned from academic
Reduced support for and total amount of CME
Great Lakes AMA CME Conference, Oct. 2006,
Boston University Medical Center, April, 2007.
Intramural NIH researchers: recruitment &
retention problems; unavailable to companies.
COI rules Licensing Sponsored Startups
have had: Technology Basic Clinical
(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
EXPLICIT OR IMPLICIT ASSUMPTIONS
Corporate research is flawed & fraudulent.
Corporate research is biased.
Conflict of interest (or appearance of
conflict of interest) erodes trust &
Corporate marketing is not evidence based
and hurts patient care.
353 : 1060, 2005
Claims that commercial interactions with academic medical centers have increased:
endangerment of research subjects,
interference with academic freedom,
corruption of academic values,
violation of scientific norms,
dereliction of academic obligations,
degradation of research quality,
loss of public trust
are simply not true --
Advertising / promotion is not “evidence-based.”
“Pharmaceutical marketing has raised persistent ethical and legal issues about conflict of interest.”
Brennan & Mello, JAMA 297 : 1255, 2007
“practicing medicine in the best interest of my patients and on the best available evidence rather than on the basis of advertising or promotion.”
JAMA 295 : 429, 2006
“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”
“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
“Guardian Syndrome” “Commercial Syndrome”
Military, Clergy, Medicine,
Power, Appearances, Trade, Contracts,
Wealth Distribution, Wealth Accrual,
Property Seizure. Private Property.
Sampling and Gifts Hurt Patients?
JAMA 295 : 429, 2006
“The systematic review of the medical
literature on (industry) gifting by Wazana
found that an overwhelming majority of
interactions had negative results on clinical
“NO STUDY USED PATIENT
JAMA 283 : 273, 2000
Improved ability to Inability to identify
identify the treatment wrong claims.
for no advantage meds.
Fast new drug prescribing
Positive attitude toward
WHAT WAZANA REALLY SAID:
(JAMA 273 : 373, 2000)
Flexible oversight; credible punishment.
Gifting & sampling on a discretionary basis
Educate physicians concerning product development & capital markets
(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.
Jailed for brawling, Mackinac I., Michigan, 1964; escaped.
Kasisi & Kondwa Orphanages, Zambia, Dec‘04-‘06
“Options for Children in
Sickle Cell Anemia
Clinical Research Center
Perspectives in Biology & Medicine 50 : 54, 2007
Journal of Investigative Dermatology 127 : 1829,