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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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slide1
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

slide2
Heart Attack

Deaths per 100K

Population

Pharma

NIH

$ Billion

40

400

30

300

20

200

10

100

1970

1980

1990

2000

Results of Biomedical R & D Spending

Cardiovascular

Disease Mortality

slide3
Papers / Year

Concerning

Conflict$

of Interest

Heart Attack

Deaths per 100K

Population

EXPLOSIVE EMERGENCE OF COI$

Gelsinger

case

400

400

Dong case

Olivieri case

300

300

Tseng

case

200

200

NIH

Consulting

Ban

Harvard Regulations

100

1970

1980

1990

2000

slide4
Clinical

Trials

Product

marketing

Practice

Guidelines

Publishing

Consulting

Conflict of

Interest$

Advisory

Work

Editorializing

& Reviewing

Startups

CME

Pharmacy

Information

Technology

Licensing

Sponsored

Research

UBIQUITY OF CONFLICT OF INTEREST$

MAKES FOR A SLIPPERY OPPONENT

slide5
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

slide6
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.

slide7
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.

slide8
WHAT THE COI CASE HAS ACHIEVED

Intramural NIH researchers: recruitment &

retention problems; unavailable to companies.

slide9
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%

Prevented 1% 3% 16% 3%

WHAT THE COI CASE HAS ACHIEVED

slide10
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.

slide11
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 --

slide12
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.”

slide13
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”

slide14
PROFESSIONALISM & “ETHICAL NORMS”

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

slide15
DRUG REPS

EDUCATORS!

slide16
MEDICINE & THE APPEARANCE STANDARD

“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.

1991

(1916-2006)

slide17
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.”

slide18
WHAT WAZANA REALLY SAID:

“NO STUDY USED PATIENT

OUTCOME MEASURES.”

JAMA 283 : 273, 2000

slide19
POSITIVE OUTCOMES NEGATIVE OUTCOMES

Improved ability to Inability to identify

identify the treatment wrong claims.

for complicated

Illnesses.Formulary requests

for no advantage meds.

Fast new drug prescribing

Positive attitude toward

drug reps.

WHAT WAZANA REALLY SAID:

(JAMA 273 : 373, 2000)

slide21
RECOMMENDATIONS

Reasonable disclosure.

Flexible oversight; credible punishment.

Gifting & sampling on a discretionary basis

Educate physicians concerning product development & capital markets

slide22
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.

slide23
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

slide24
THANK YOU FOR YOUR ATTENTION!

Further Reading:

Perspectives in Biology & Medicine 50 : 54, 2007

Journal of Investigative Dermatology 127 : 1829,

2007

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