Industry Collaboration & Interactions With Health Professionals -- Can Conflicts of Interest be Properly Managed?

Tom Stossel Brigham & Women’s Hospital

Harvard Medical School

FDA REGULATORY & COMPLIANCE SYMPOSIUMAugust 22, 2007

Results of Biomedical R & D Spending

40

20

30

10

1970 1980 1990 2000

$ Billion

Heart AttackDeaths per 100K Population

400

200

300

100

Pharma

NIH CardiovascularDisease Mortality

1970 1980 1990

400

200

300

100

2000

400

200

300

Papers / Year Concerning Conflict$ of Interest

EXPLOSIVE EMERGENCE OF COI$

Heart AttackDeaths per 100K Population

NIHConsulting Ban

Tseng case

Dong caseOlivieri case

Gelsinger case

Harvard Regulations

Publishing

UBIQUITY OF CONFLICT OF INTEREST$ MAKES FOR A SLIPPERY OPPONENT

Productmarketing

PracticeGuidelines

Conflict of Interest$

Sponsored Research

Advisory Work

CME

PharmacyInformation

Startups

Editorializing & ReviewingTechnology

Licensing

Clinical Trials

Consulting

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

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.

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 Startupshave 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

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.

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 trustare simply not true --

353 : 1060, 2005

THE CASE FOR CONFLICT OF INTEREST$ Advertising / promotion is not “evidence-based.”

“practicing medicine in the best interest of my patients and on the best available evidence rather than on the basis of advertising or promotion.”

“Pharmaceutical marketing has raised persistent ethical and legal issues about conflict of interest.” Brennan & Mello, JAMA 297 : 1255, 2007

THE BOGUS CASE FOR CONFLICT OF INTERESTS

“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”

JAMA 295 : 429, 2006

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

PROFESSIONALISM & “ETHICAL NORMS”

EDUCATORS!

DRUG REPS

“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.

(1916-2006)

1991

MEDICINE & THE APPEARANCE STANDARD

THE EMPIRIC CASE FOR CONFLICT OF INTERESTS Sampling and Gifts Hurt Patients?

“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.”

JAMA 295 : 429, 2006

“NO STUDY USED PATIENT OUTCOME MEASURES.”

JAMA 283 : 273, 2000

WHAT WAZANA REALLY SAID:

POSITIVE OUTCOMES NEGATIVE OUTCOMES

Improved ability to Inability to identify identify the treatment wrong claims.for complicatedIllnesses. Formulary requests for no advantage meds.

Fast new drug prescribing

Positive attitude toward drug reps.

WHAT WAZANA REALLY SAID: (JAMA 273 : 373, 2000)

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): 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.

Harmonies of Interest Enable Giving Back Kasisi & Kondwa Orphanages, Zambia, Dec‘04-‘06

“Options for Children inZambia” (5013c).

Sickle Cell Anemia Clinical Research Center University Teaching Hospital, Lusaka

QuickTime™ and aTIFF (Uncompressed) decompressor

are needed to see this picture.

Further Reading:

Perspectives in Biology & Medicine 50 : 54, 2007Journal of Investigative Dermatology 127 : 1829,

2007

THANK YOU FOR YOUR ATTENTION!