Download Powerpoint

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
Results of Biomedical R & D Spending
Pharma
NIH
Cardiovascular
Disease Mortality
$ Billion
Heart Attack
Deaths per 100K
Population
40
400
30
300
20
200
10
100
1970
1980
1990
2000
EXPLOSIVE EMERGENCE OF COI$
Heart Attack
Deaths per 100K
Population
Gelsinger
case
Papers / Year
Concerning
Conflict$
of Interest
400
300
400
Dong case
Olivieri case
300
Tseng
case
200
200
Harvard Regulations
100
1970
1980
1990
2000
NIH
Consulting
Ban
UBIQUITY OF CONFLICT OF INTEREST$
MAKES FOR A SLIPPERY OPPONENT
Clinical
Trials
CME
Technology
Licensing
Startups
Product
marketing
Practice
Guidelines
Editorializing
& Reviewing
Conflict of
Interest$
Advisory
Work
Sponsored
Pharmacy Research
Publishing Information
Consulting
THE CASE FOR CONFLICT$ OF INTEREST
Commerce and entrepreneurial activity are
important for medical advances.
BUT
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.
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.
WHAT THE COI CASE HAS ACHIEVED
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
Startups
have had: Technology Basic Clinical
Research
(6069)
(2108) (1242)
(506)
No effect
81%
77%
64%
64%
Delayed
18%
20%
20%
33%
1%
3%
16%
3%
Prevented
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.
353 : 1060, 2005
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 trust
are simply not true --
THE CASE FOR CONFLICT OF INTEREST$
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.”
THE BOGUS CASE FOR CONFLICT OF INTERESTS
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”
PROFESSIONALISM & “ETHICAL NORMS”
“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
Hippocrates
DRUG REPS
EDUCATORS!
MEDICINE & THE APPEARANCE STANDARD
“Guardian Syndrome” “Commercial Syndrome”
Government,
Military, Clergy,
Judiciary,
Public
Health Officials.
Power, Appearances,
Wealth Distribution,
Property Seizure.
Businesses,
Medicine,
Science.
1991
(1916-2006)
Trade, Contracts,
Wealth Accrual,
Private Property.
THE EMPIRIC CASE FOR CONFLICT OF INTERESTS
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
care.”
WHAT WAZANA REALLY SAID:
“NO STUDY USED PATIENT
OUTCOME MEASURES.”
JAMA 283 : 273, 2000
WHAT WAZANA REALLY SAID:
(JAMA 273 : 373, 2000)
POSITIVE OUTCOMES
Improved ability to
identify the treatment
for complicated
Illnesses.
NEGATIVE OUTCOMES
Inability to identify
wrong claims.
Formulary requests
for no advantage meds.
Fast new drug prescribing
Positive attitude toward
drug reps.
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):
(PAST):
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).
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 in
Zambia” (5013c).
Sickle Cell Anemia
Clinical Research Center
University Teaching
Hospital, Lusaka
THANK YOU FOR YOUR ATTENTION!
QuickTime™ and a
TIFF (Uncompressed) decompressor
are needed to see this picture.
Further Reading:
Perspectives in Biology & Medicine 50 : 54, 2007
Journal of Investigative Dermatology 127 : 1829,
2007