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HOW FINANCIAL CONFLICTS OF INTEREST ENDANGER OUR PROFESSION JEROME P. KASSIRER, M.D.

HOW FINANCIAL CONFLICTS OF INTEREST ENDANGER OUR PROFESSION JEROME P. KASSIRER, M.D. DISTINGUISHED PROFESSOR, TUFTS UNIVERSITY SCHOOL OF MEDICINE VISITING PROFESSOR, STANFORD UNIVERSITY EDITOR-IN-CHIEF EMERITUS, NEW ENGLAND JOURNAL OF MEDICINE. MY CONFLICT OF INTEREST Oxford University Press

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HOW FINANCIAL CONFLICTS OF INTEREST ENDANGER OUR PROFESSION JEROME P. KASSIRER, M.D.

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  1. HOW FINANCIAL CONFLICTS OF INTEREST ENDANGER OUR PROFESSION • JEROME P. KASSIRER, M.D. • DISTINGUISHED PROFESSOR, TUFTS UNIVERSITY SCHOOL OF MEDICINE • VISITING PROFESSOR, STANFORD UNIVERSITY • EDITOR-IN-CHIEF EMERITUS, NEW ENGLAND JOURNAL OF MEDICINE

  2. MY CONFLICT OF INTEREST • Oxford University Press • October, 2004

  3. RHETORICAL QUIZ: • WHAT’S YOUR CHOLESTEROL? YOUR LDL? ARE YOU TRYING TO LOWER IT?

  4. RHETORICAL QUIZ: • WHAT’S YOUR CHOLESTEROL? YOUR LDL? ARE YOU TRYING TO LOWER IT? • ARE YOU TAKING STATINS?

  5. RHETORICAL QUIZ: • WHAT’S YOUR CHOLESTEROL? YOUR LDL? ARE YOU TRYING TO LOWER IT? • ARE YOU TAKING STATINS? • DO YOU KEEP TRACK OF NCEP GUIDELINES?

  6. RHETORICAL QUIZ: • WHAT’S YOUR CHOLESTEROL? YOUR LDL? ARE YOU TRYING TO LOWER IT? • ARE YOU TAKING STATINS? • DO YOU KEEP TRACK OF NCEP GUIDELINES? • ARE YOU USING THEM?

  7. RHETORICAL QUIZ: • WHAT’S YOUR CHOLESTEROL? YOUR LDL? ARE YOU TRYING TO LOWER IT? • ARE YOU TAKING STATINS? • DO YOU KEEP TRACK OF NCEP GUIDELINES? • ARE YOU USING THEM? • DO YOU KNOW WHO DEVELOPED THE GUIDELINES?

  8. RHETORICAL QUIZ: • WHAT’S YOUR CHOLESTEROL? YOUR LDL? ARE YOU TRYING TO LOWER IT? • ARE YOU TAKING STATINS? • DO YOU KEEP TRACK OF NCEP GUIDELINES? • ARE YOU USING THEM? • DO YOU KNOW WHO DEVELOPED THE GUIDELINES? • DO YOU TRUST THEIR ADVICE?

  9. NCEP GUIDELINES JULY ’04 • (Sponsors: NIH, AHA, ACC) • Reviewed these studies: • PROSPER • ALLHAT-LLT • ASCOT-LLA • PROVE IT-TIMI 22 • HPS

  10. THE EXPERT NCEP PANEL • S. Scott Grundy Director, Center Human Nutrition, Southwestern • Brairey Merz, Director Preventive/Rehab. Cardiac Center, Cedars-Sinai • H. Bryan Brewer, Chief, Molecular Disease Branch, NHLBI • Luther T. Clark, Chief, Division Cardiology, SUNY at Brooklyn • Donald Hunninghake, Professor of Pharmacol. and Medicine, U. Minnesota • Richard Pasternak, Director of Preventative Cardiol. And Cardiac Rehabilitation, MGH • Sidney Smith, Director of Center for Cardiovasc. Science, UNC; former AHA President • Neil Stone, Professor of Cardiology, Northwestern • James Cleeman, Coordinator, NCEP (NIH)

  11. NEW NCEP GUIDELINES JULY ’04 • Recommendation: • Aggressive LDL lowering for high risk patients with lifestyle changes (diet, exercise) and statins • (Primary prevention)

  12. THERAPEUTICS INITIATIVE U.B.C. • (No industry support) • Reviews these studies: • PROSPER • ALLHAT-LLT • ASCOT-LLA • AFCAPS • WOSOP

  13. THERAPEUTICS INITIATIVE U.B.C. • (No industry support) • Conclusion: • Statins have not been shown to provide an overall health benefit in primary prevention trials

  14. NCEP PANEL’S FINANCIAL CONFLICTS • (PERSONAL INCOME – HONORARIA, CONSULTING FEES • FROM ALL 5STATIN COMPANIES) • Grundy 5 Hunninghake 4 • Pasternak 5 Merz 3 • Stone 5 Smith 0 • Brewer 4 Cleeman 0 • Clark 4

  15. FOLLOW-UP • OCTOBER 2006 • 2004 NCEP GUIDELINES QUESTIONED • EVIDENCE BASE FOR ORIGINAL RECOMMENDATIONS WAS WEAK AND BASED ON SECONDARY PREVENTION • SOME ORIGINAL AUTHORS BACK OFF (NYT) • (Ann. Intern. Med 2006;145:520-530; Lancet 2007;369:168-169)

  16. DRUG INDUSTRY MARKETING* • (billions) • Samples 15.9 • Detailing 20.4 • Direct to consumer 4.0 • Meetings 2.0 • Journal ads 0.5 • Misc. 14.7 • TOTAL 57.5 BILLION DOLLARS! • (APPROX. 90% DIRECTED AT PHYSICIANS) • *2004 • Gagnon, Lexchin, PLoS Med 2008; 5(1):e1

  17. “EPIDEMIOLOGY” 1662 random physicians: 83% took gifts, 16-18% paid consulting or speaking 459 Department chairs: >25% paid consulting or speaking or both. >66% said arrangements had no effect on professional activities JAMA (2007) 298:1779-1786 NEJM (2007) 356:1742-1750

  18. FERVENT BELIEFS OF OBJECTIVITY • TRAINED IN THE SCIENTIFIC METHOD • RELIGIOUS ADHERENCE TO EVIDENCE-BASED MEDICINE

  19. SELF-DECEPTION? • HOUSE OFFICERS AT UCSF: • CAN YOU BE INFLUENCED? • CAN YOUR COLLEAGUES BE INFLUENCED?

  20. SELF-DECEPTION? • HOUSE OFFICERS AT UCSF: • CAN YOU BE INFLUENCED? • 39% YES • CAN YOUR COLLEAGUES BE INFLUENCED?

  21. SELF-DECEPTION? • HOUSE OFFICERS AT UCSF: • CAN YOU BE INFLUENCED? • 39% YES • CAN YOUR COLLEAGUES BE INFLUENCED? • 84% YES

  22. THE CANDY EXPERIMENT AT CORNELL’S HOTEL SCHOOL • THE GIFTTHE TIP • NO CANDY • ONE PIECE • TWO PIECES • ONE PLUS ONE

  23. THE CANDY EXPERIMENT AT CORNELL’S HOTEL SCHOOL • THE GIFTTHE TIP • NO CANDY 19.0% • ONE PIECE • TWO PIECES • ONE PLUS ONE

  24. THE CANDY EXPERIMENT AT CORNELL’S HOTEL SCHOOL • THE GIFTTHE TIP • NO CANDY 19.0% • ONE PIECE 19.6% • TWO PIECES • ONE PLUS ONE

  25. THE CANDY EXPERIMENT AT CORNELL’S HOTEL SCHOOL • THE GIFTTHE TIP • NO CANDY 19.0% • ONE PIECE 19.6% • TWO PIECES 21.6% • ONE PLUS ONE

  26. THE CANDY EXPERIMENT AT CORNELL’S HOTEL SCHOOL • THE GIFTTHE TIP • NO CANDY 19.0% • ONE PIECE 19.6% • TWO PIECES 21.6% • ONE PLUS ONE 23.0%

  27. “ I CAN RESIST ANYTHING BUT TEMPTATION” • (OSCAR WILDE, LADY WINDERMERE’S FAN, 1892, ACT 1)

  28. Not all incentives are financial…

  29. Not all incentives are financial… • Nina Easton, a reporter for Fortune Magazine, was asked how she can be objective when discussing John McCain’s presidential candidacy on Fox News given that her husband is McCain’s media advisor. She replied, • “Disclosure is the great disinfectant.” • ( NPR, April 1st 2007)

  30. ACADEMIC-INDUSTRY RELATIONS: • BENEFITS TO SOCIETY • Research collaboration • Drug development • Device development and modification • Consultations on scientific issues • Who do all other industry-paid activities benefit? • (Balanced view by Bernie Lo NEJM Feb 25, 2010)

  31. Assumption: • EVEN SMALL GIFTS INFLUENCE BEHAVIOR Principles: • FINANCIAL CONSIDERATIONS NEVER COMPROMISE MD DECISION-MAKING • MEDICAL INFORMATION FREE OF BIAS FROM FINANCIAL INDUCEMENTS • PROFESSION ACCOUNTABLE FOR INORDINATELY HIGH COST OF CARE • ALL FINANCIAL ARRANGEMENTS OPEN AND TRANSPARENT

  32. DO FINANCIAL CONFLICTS TRANSLATE INTO BIAS?

  33. DIAGNOSIS

  34. INTERPRETATION OF CHEST X-RAYS • 492 abnormal chest X-rays, according to 30 plaintiff-hired “B” readers (hirees). • Films re-read by 6 blinded “B” readers (independents). • (“B” readers are certified by NIOSH; all used standard DHSS form OMB No. 0920-0020) • Gitlin et al Acad. Radiol 2004;11:843-856

  35. RESULTS • (%) • hirees independents • ------- ---------------- • Parench. abn. 96 5 • Pneumocon. 97 6 • Pleural abn 26 8 • Film normal 0 38

  36. Off-label • drug use. • What’s • the real • motive?

  37. GELSINGER CASE, 1999 • Phase I gene therapy trial • 17-year old subject died • Several lapses in implementation of research protocol, including consent forms • U Penn, Dr. James Wilson (PI) both had equity in Genovo, Inc. • Was the research pressed forward for financial reasons?

  38. SCREENING FOR LUNG CANCER • Oct. ’06 NEJM lung cancer study “IELCAP” 10 yr. survival >90%! PIs Henschke and Yalkelewitz (Cornell) • PIs and “Lung Cancer Alliance” urged CT screening for smokers, payment for screening, called double blind NIH screening trial (NLST) “unethical,” complained to Zerhouni, and convinced Congressional committee to investigate PIs of NLST. • No other medical organization agrees screening is justified • NEJM study is seriously flawed* • Cancer Letter (Jan 18, 2008) discovers that Cornell PI’s have 27 undisclosed patents on CT screening; other authors would stand to gain enormously. • (*H.G. Welch et al. Arch Intern Med Nov. 26, 2007)

  39. KDOQI GUIDELINES ON EPO USE, 2006 • CHAIR AND VICE CHAIR OF STEERING COMMITTEE, CO-CHAIRS OF WORK GROUP WERE CONSULTANTS FOR AMGEN OR ORTHO-BIOTECH, OR BOTH • 11/15 MEMBERS OF WORK GROUP HAD SIMILAR FINANCIAL CONFLICTS • AMGEN WAS THE FOUNDER AND PRINCIPAL SPONSOR OF THE GUIDELINE DEVELOPMENT • CONFLICTS OF THE 40 ADVISORY BOARD MEMBERS AND NKF OFFICERS NOT REVEALED

  40. “WHEN THE LEADERS OF THE NATIONAL KIDNEY FOUNDATION APPOINTED THE HEAVILY CONFLICTED 2006 KDOQI ANEMIA WORK GROUP ON THE USE OF ERYTHROPOEITIN STIMULATING PROTEIN, WERE THEY OBLIVIOUS TO THE POSSIBILITY THAT ANY RECOMMENDATION OF THE PANEL WOULD BE CONSIDERED SUSPECT?” • (KASSIRER JP. STACKING THE DECK. CLIN J AM SOC NEPHROL 2007;2:212)

  41. STACKING THE DECK • "The evidence indicates that Iraq is reconstituting its nuclear weapons program. Saddam Hussein has held numerous meetings with Iraqi nuclear scientists, a group he calls his ‘nuclear mujahideen’-- his nuclear holy warriors. Satellite photographs reveal that Iraq is rebuilding facilities at sites that have been part of its nuclear program in the past. Iraq has attempted to purchase high-strength aluminum tubes and other equipment needed for gas centrifuges, which are used to enrich uranium for nuclear weapons."

  42. ARE THE EPO GUIDELINES BIASED?

  43. ARE THE EPO GUIDELINES BIASED? • WHO KNOWS?

  44. ARE THE EPO GUIDELINES BIASED? • WHO KNOWS? • FUNDING BY A COMPANY AND PARTICIPATION BY CONFLICTED INDIVIDUALS RAISES SUSPICION THAT THE GUIDELINES ARE BIASED. • IT DOES NOT PROVE THAT THEY ARE BIASED.

  45. NATIONAL KIDNEY FOUNDATION • CONFLICT OF INTEREST POLICY • DISCLOSURES ANNUALLY BY ALL VOLUNTEERS, REVIEWED BY NKF AUDIT COMMITTEE • DISCLOSURES TO INCLUDE DOLLAR AMOUNTS (>$10,000) • CONFLICTS OVERSEEN BY NKF COMPLIANCE OFFICER • “SIGNIFICANT” CONFLICTS TO BE “MANAGED” • DISCLOSURE DATA OPENLY REVIEWED AT EACH KDOQI WORK GROUP MEETING • DISCLOSURES PUBLISHED WITH GUIDELINES • TOTAL SEPARATION OF FUNDING AND CONTENT • MULTIPLE SPONSORS FOR ALL GUIDELINES • (http://www.kidney.org/professionals/KDOQI/guidelinesCOI.cfm. Accessed 9/19/07)

  46. NATIONAL KIDNEY FOUNDATION • CONFLICT OF INTEREST POLICY • DISCLOSURES ANNUALLY BY ALL VOLUNTEERS, REVIEWED BY NKF AUDIT COMMITTEE • DISCLOSURES TO INCLUDE DOLLAR AMOUNTS (>$10,000) • CONFLICTS OVERSEEN BY NKF COMPLIANCE OFFICER • “SIGNIFICANT” CONFLICTS TO BE “MANAGED” • DISCLOSURE DATA OPENLY REVIEWED AT EACH KDOQI WORK GROUP MEETING • DISCLOSURES PUBLISHED WITH GUIDELINES • TOTAL SEPARATION OF FUNDING AND CONTENT • MULTIPLE SPONSORS FOR ALL GUIDELINES • (http://www.kidney.org/professionals/KDOQI/guidelinesCOI.cfm. Accessed 9/19/07)

  47. NATIONAL KIDNEY FOUNDATION • CONFLICT OF INTEREST POLICY • DISCLOSURES • DISCLOSURES • DISCLOSURE • DISCLOSURES • (http://www.kidney.org/professionals/KDOQI/guidelinesCOI.cfm. Accessed 9/19/07)

  48. “MANAGING” CONFLICTS OF INTEREST • DISCLOSURE IS WIDELY CONSIDERED • “THE GREAT DISINFECTANT” • BUT IS IT?

  49. The limits of full disclosure

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