David J. Rothman, Ph.D. Bernard Schoenberg Professor of Social Medicine

1. Managing Conflict of Interest The Challenge of Pharmaceutical Company Marketing to Medical Professionalism David J. Rothman, Ph.D. Bernard Schoenberg Professor of Social Medicine Columbia College of Physicians and Surgeons www.societyandmedicine.columbia.edu President Institute on Medicine as a Profession www.imapny.org Associate Director The Prescription Project www.prescriptionproject.org

2. INSTITUTE ON MEDICINE AS A PROFESSION Managing Conflict of Interest

3. PRESCRIPTION PROJECT Managing Conflict of Interest

4. Context: The Wind at Our Back Increasing concern about marketing. Why? • Surge in healthcare spending • Prominent legal cases (e.g. TAP, Vioxx, Guidant) • Media attention to physician-industry ties: • Gifts and meals to providers and formulary decision-makers • Undisclosed support to researchers • Off-label promotion • Industry ties to authors of treatment guidelines • Cheerleaders as sales reps Managing Conflict of Interest

5. Press Coverage July 2006 • The San Jose Mercury News, “Science Critics Make Issue of Financial Ties”: Stanford psychiatrist accused of recommending a drug treatment in which he had a financial interest. Doctor co-founded company that would make and sell the drug. • The Wall Street Journal, “Financial Ties to Industry Cloud Major Depression Study”: Depression study authors failed to disclose financial ties to makers of anti-depressants. Study’s results were seen as a boon for the anti-depressant drug makers. • The New York Times, “Hospital Chiefs Get Paid for Advice on Selling to Hospitals”: Hospital executives receive substantial fees and lavish vacations in exchange for advising vendors on marketing to hospitals - seen as a way for industry to curry favor with those who control major purchasing decisions. • The New York Times, “Indictment of Doctor Tests Drug Marketing Rules”: Doctor arrested for receiving payments to widely market a prescription drug containing GHB, the “date rape” drug, despite dearth of clinical trial data. Managing Conflict of Interest

6. Press Coverage July 2006(con’t) • The New York Times, “Our Conflicted Medical Journals” editorial: After disclosure failures at prominent medical journals, New York Times’ editors urge more forceful control of conflicts of interest. • The New York Times, “Rules Planned for Industry Ties to F.D.A. Boards”: F.D.A. responds with more guidelines after scandals over advisory board members’ financial ties. • The Boston Globe, “Article Urging Heart Exams Shows Conflict of Interest”: Recent cardiology scan recommendations tainted by pharmaceutical industry funding. Recommendations would lead to greater prescription use, industry profits. • The New York Times, “Drug Makers Pay for Lunch as They Pitch”: Drug companies give doctors lunch to listen to their marketing spiel. Doctors’ integrity questioned. Managing Conflict of Interest

7. What is “Conflict of Interest”? “When primary responsibilities of professionals are compromised by pursuing interests external to their responsibilities.” - Neil Smelser, University of California-Berkeley Managing Conflict of Interest

8. Conflict of Interest in the Polity and the Society • Should a loan department officer dine or gift the college student loan administrator to increase referrals? • Should a lobbying group dine or gift a state legislator or congressman to advance legislation? • Should a brokerage house dine or gift a mutual fund administrator to attract their stock purchases? • Should an apparel designer dine or gift the department store purchasing agent to seal the purchase? • Should a public agency dine or gift a journalist to spin a story? Most will answer no to the above questions. Managing Conflict of Interest

9. Why We Say No: Core Principles • Commitment to organizational integrity and client welfare. • Decision-making should be free of personal bias. • Gifts of any size (even small ones) are influential. • Disclosure is not a sufficient cure. Managing Conflict of Interest

10. Conflict of Interest in Medicine Is there any reason why doctors and drug companies should be allowed to play by different rules? Managing Conflict of Interest

11. Research Findings Central to our Deliberations Wazana, JAMA (2000; 283: 373-380) • Meetings with pharmaceutical representatives were associated with requests by physicians for adding the drugs to the hospital formulary and changes in prescribing practice. • Company-sponsored continuing medical education (CME) preferentially highlighted the sponsor’s product(s) compared with other CME programs. Managing Conflict of Interest

12. Research Findings Central to our Deliberations Wazana, JAMA (2000; 283: 373-280) • Attending sponsored CME events and accepting funding for travel or lodging for educational symposia were associated with increased prescription rates of the sponsor’s products. • Attending presentations given by pharmaceutical representative speakers was also associated with nonrational prescribing. Managing Conflict of Interest

13. Managing Conflict of Interest

14. “Known for their athleticism, postage-stamp skirts and persuasive enthusiasm, cheerleaders have many qualities the drug industry looks for in its sales force…. Drug companies have found that former cheerleaders are good at persuading doctors.” “Gimme an Rx! Cheerleaders Pep Up Drug Sales”NY Times, 11/28/05 Managing Conflict of Interest

15. The Other Merck Manual Managing Conflict of Interest

16. Journal of the American Medical Association January 25th, 2006 (295: 429-433) Managing Conflict of Interest

17. Recommendations to Academic Medical Centers for Controlling Conflicts of Interest Managing Conflict of Interest

18. Recommendations to Academic Medical Centers for Controlling Conflicts of Interest Managing Conflict of Interest

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20. “Seducing the Medical Profession”NYTimes Op-Ed, 2/2/06 Managing Conflict of Interest

21. NY Times, 2/12/07 David J. Rothman: “Gifts bring with them the felt need to reciprocate…We’re not saying you’re being bribed. We’re saying you’re being gifted. Some of it could be raw monetary hustling. But some of it is this psychological – ‘Well, they just sent me out to Las Vegas, their drug is as good as anybody else’s, why not just say thank you.’” Managing Conflict of Interest

22. AMCs Leading the Way • Yale University • University of Pennsylvania • Stanford University • University of Michigan • University of Washington • Kaiser Permanente • UC Davis • UC System • University of Arizona Managing Conflict of Interest

23. Catalysts for Change • Leadership • Change was “top down” at many AMCs. • Sensitivity to Media Coverage • Fear of institutional embarrassment through scandal. • An Opportunity to Exercise Professional Leadership Managing Conflict of Interest

24. Barriers to Change • Dependency on Drug Company Funding. • Ignorance of What Leading AMCs and Societies are Doing. • Decentralized Hospital/Educational Structure. • Fear of Faculty Resistance. Managing Conflict of Interest

25. What would the new world of medicine Managing Conflict of Interest look like? • Decisions by physicians would become more evidence-based. • Better patient outcomes. • Expenditures on prescription drugs would decline. • Increased use of generic products. • A decreased reliance on inappropriate pharmaceutical agents. • An absence of industry representatives at AMC meetings and lunches. • Increased sensitivity among medical students and house staff to the values of medical professionalism and scientific integrity. Managing Conflict of Interest