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Industry Collaboration & Interactions With Health Professionals -- Can Conflicts of

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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Industry Collaboration & Interactions With Health Professionals -- Can Conflicts of

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  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  7. 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.

  8. WHAT THE COI CASE HAS ACHIEVED Intramural NIH researchers: recruitment & retention problems; unavailable to companies.

  9. 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

  10. 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.

  11. 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 --

  12. 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.”

  13. 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”

  14. 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

  15. DRUG REPS EDUCATORS!

  16. 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)

  17. 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.”

  18. WHAT WAZANA REALLY SAID: “NO STUDY USED PATIENT OUTCOME MEASURES.” JAMA 283 : 273, 2000

  19. 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)

  20. DRUG REPS

  21. RECOMMENDATIONS Reasonable disclosure. Flexible oversight; credible punishment. Gifting & sampling on a discretionary basis Educate physicians concerning product development & capital markets

  22. 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.

  23. 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

  24. 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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