1. Teaching Professionalism to Residents: The Management of Conflict of Interest in Medicine NORMAN B. KAHN, JR. MD COUNCIL OF MEDICAL SPECIALTY SOCIETIES UMKC SCHOOL OF MEDICINE MAY 27, 2011

2. Pre-test – 1 of 2 What agencies’ codes or laws guide the behaviors and relationships of:  Physicians  Physicians with pharmaceutical and medical device industries  Physician organizations  Physician organizations with pharmaceutical and medical device manufacturers  Pharmaceutical representatives  Pharmaceutical representatives with physicians  Medical device company representatives  Medical device company representatives with physicians  Pharmaceutical and medical device companies  Pharmaceutical and medical device companies with the public  Continuing medical education providers  Academic Medical Centers  Academic Medical Centers with Industry  Residency Programs  Residency Programs with Industry

3. Pre-test – 2 of 2 What are consequences of violations of codes or laws governing behaviors and relationships of:  Physicians  Physicians with the pharmaceutical and medical device industries  Physician organizations  Physician organizations with pharmaceutical and medical device manufacturers  Pharmaceutical representatives  Pharmaceutical representatives with physicians  Medical device company representatives  Medical device company representatives with physicians  Pharmaceutical and medical device companies  Pharmaceutical and medical device companies with the public  Continuing medical education providers  Academic Medical Centers  Academic Medical Centers with Industry  Residency Programs  Residency Programs with Industry

4. Is Medicine a Business, a Profession, or Both? The practice of medicine in the US is a lucrative field of work, with many opportunities to enhance personal income Medicine is a profession, in which professionals enter into an implied contract with society, accepting certain responsibilities in exchange for certain privileges (conditional autonomy, relative wealth) The natural consequence of the perceived failure of the profession to fulfill its part of the social contract results in consumerism, with calls for external (governmental) regulation

5. Professionalism Professionalism - The Social Contract Professionalism: – Altruism Making sure the needs of patients come first – Voluntary self-regulation ACGME, ACCME-SCS, AAMC, ACME, AANC, ACPE, AMA, CMSS, PhRMA, AdvaMed – Transparency Peers – disclosure Patients Public

6. Codes, Standards and Laws in the Arena of Conflict of Interest AMA AMA – Council on Ethical and Judicial Affairs – Ethical Opinion 8.061, Gifts to Physicians from Industry – guides physicians AAMC AAMC – Report of the Task Force on Industry Funding of Medical Education – guides Academic Medical Centers ACCME ACCME – Standards for Commercial Support: Standards to Ensure the Independence of CME – governs CME Providers (also nursing and pharmacy) ACGME ACGME – Principles to Guide the Relationships Between Graduate Medical Education and industry – guides residency programs AdvaMed AdvaMed – Code of Ethics on Interactions with Health Professionals – guides representatives of device manufacturers PhRMA PhRMA – Code on Interactions with Health Professionals – guides representatives of pharmaceutical companies PPSA PPSA – Physician Payments Sunshine Act – requires companies to disclose payments to physicians FDA FDA – oversees drug and device manufacturers OIG OIG – oversees drug and device manufacturers CMSS CMSS – Code for Interactions with Companies – guides specialty societies

7. Watchdogs over the Profession 1. Legislative Branch of Government 1. Legislative Branch of Government - Senate Finance and Aging Committees 2. Executive Branch of Government 2. Executive Branch of Government – current rules are for companies (FDA, OIG), soon will write rules for physicians (PPSA) 3. The Public Media 3. The Public Media – New York Times, Wall Street Journal, Washington Post, Blogs, etc. 4. The Professional Media 4. The Professional Media – JAMA April 1, 2009, etc. 5. The Institute of Medicine 5. The Institute of Medicine – April 28, 2009 Report on Conflict of Interest in Medical Research, Education and Practice

8. Wall Street Journal: Medicare spending on spinal fusion surgery went from costing Medicare $343 million in 1997 to $2.24 billion in 2008. Five senior spine surgeons at Norton Hospital in Louisville, KY, performed the third-most spinal fusions on Medicare patients in the country and received more than $7 million from Medtronic in the first nine months of this year alone. http://tinyurl.com/27xsbqt http://tinyurl.com/27xsbqt San Francisco Chronicle: An article was referenced by ProPublica concerning Stanford faculty members who still receive funding from industry, in apparent contradiction to Stanford's rigorous conflicts of interest policies. http://tinyurl.com/25ybaes http://deansnewsletter.stanford.edu/#4 http://tinyurl.com/25ybaes http://deansnewsletter.stanford.edu/#4

9. “Researchers fail to reveal full drug pay,” New York Times, June 8, 2008 A Senate Finance Committee investigation revealed that Dr. Joseph Biederman, an influential Harvard child psychiatrist whose work helped fuel a 40-fold increase of pediatric bipolar diagnoses between 1994 and 2003, failed to disclose $1.6 million in drug company payments between 2000 and 2007. Two faculty colleagues underreported their $1 million+ earnings, as well. “Medical device maker paid UW surgeon $19 million,” Milwaukee Journal-Sentinel, January 16, 2009 University of Wisconsin orthopedic surgeon Dr. Thomas Zdeblick received more than $19 million from Medtronic medical device company between 2003 and 2007, a Senate Finance Committee investigation revealed, though Zdeblick only disclosed receiving “more than $20,000” per year to his university.

10. WASHINGTON --- Senator Chuck Grassley asked 23 medical schools and 33 medical societies for information about their policies for conflicts of interest and requirements for disclosure of financial relationships between faculty members and the drug industry. "There's a lot of skepticism about financial relationships between doctors and drug companies," Grassley said. "Disclosure of those ties would help to build confidence that there's nothing to hide. Requiring disclosure is a common sense reform based on the public dollars and public trust at stake in medical training, medical research and the practice of medicine." The Federal Government at Work Grassley seeks information about medical school policies for disclosure of financial ties

11. PPSA PPSA Physician Payments Sunshine Act Became law March 23, 2010 Requires drug and device manufacturers to disclose on their websites payments to physicians In response to investigation and publication of names, relationships and amounts of money paid by industry to, but not disclosed by, physicians Implied violations of Professionalism  Altruism – did these physicians put their interests before the interests of their patients?  Voluntary self-regulation – did the profession regulate its members to prevent abuses?  Transparency – these physicians did not fully disclose their relationships and the payments they received

12. AMA CEJA AMA CEJA American Medical Association Council on Ethical and Judicial Affairs Ethical Opinion 8.061 - Gifts to Physicians from Industry (1998) Guides the behavior of physicians when offered gifts from industry Gifts must benefit patients Non-substantial value Related to physician’s work No CME or travel subsidy directly to docs No token consulting relationships Trainee scholarships to training institution, which selects trainees and conferences No “strings attached”

13. AMA CEJA AMA CEJA - Consequences of Violation Potential loss of membership in AMA Potential loss of membership in specialty society

14. PhRMA PhRMA Pharmaceutical Research and Manufacturers of America Code on Interactions with Health Professionals (2009) Guides the behaviors of pharmaceutical representatives in relationships with individual physicians No support for entertainment/recreation Support for CME Promotional education Consultants Speakers Bureaus Clinical Practice Guidelines No non-educational or non-practice related gifts, but educational items are OK

15. PhRMA Code – Consequences of Violation Voluntary Code All PhRMA member companies and more have signed on to the PhRMA Code Annual attestation to PhRMA Listing on PhRMA website Risk of federal and state government regulation  FDA  OIG  MA, VT, others

16. AdvaMed AdvaMed Advanced Medical Technology Association Code of Ethics on Interactions with Health Professionals (2009) Guides employees of medical device manufacturers in relationships with physicians Similar provisions to PhRMA Code, plus… Royalty arrangements Demonstration of new products

17. AdvaMed Code Consequences of Violation Voluntary Code Annual attestation to AdvaMed Listing on AdvaMed website Risk of government intervention

18. ACCME ACCME Accreditation Council for Continuing Medical Education Standards for Commercial Support: Standards to Ensure the Independence of CME Activities (2004) Guides providers of CME programming Independence of CME providers: CME planning and delivery is “free of the control of a commercial interest” No exhibits or ads in CME space No bias in CME programming Disclosure and resolution of conflict of interest  Faculty  Authors  Planning committees  To learners

19. ACCME Consequences of Violation Probation, then … Loss of accreditation to offer CME programming for AMA PRA CME credit

20. AAMC AAMC Report of the Task Force on Industry Funding of Medical Education Guidance to Medical Schools and Academic Health Centers No gifts to physicians Limits drug detailing Assurance that CME complies with the ACCME-SCS Discourages faculty participation in industry speakers bureaus Full transparency and Disclosure No ghostwriting

21. AAMC Consequences of Violation AAMC recommendations, intended to lead to … Institutional policies and compliance

22. ACGME ACGME Principles to Guide the Relationships Between Graduate Medical Education and Industry Promote Professionalism in residency programs and sponsoring institutions Ethics curricula to include the ethics of gifts to physicians Full disclosure of commercial support of CME and research Policies on contacts between residents and industry Teach residents the difference between education and promotional, the purpose of formularies, guidelines, cost- benefit analyses in prescribing, and how to manage relationships with industry representatives

23. ACGME Consequences of Violation Guiding principles Monitored through Institutional Reviews

24. FDA FDA US Food and Drug Administration Oversees drug and device manufacturers Approves drugs and devices for approved (“on-label”) uses Assures efficacy Monitors safety

25. FDA - Consequences of Violation “Black box” warnings Consumer alerts Drug recalls Fraud and criminal investigations Civil and criminal penalties

26. OIG OIG Office of the Inspector General, US Department of Health and Human Services Oversees drug and device manufacturers “Protect[s] the integrity of the Department of Health and Human Services programs, as well as the health and welfare of the beneficiaries of those programs” Audits Investigations Inspections

27. OIG – Consequences of Violation Fraud and criminal investigations Civil and criminal penalties Significant (compared with FDA):  Very large fines (more than “the cost of doing business”)  Potential incarceration of responsible parties

28. CMSS CMSS Council of Medical Specialty Societies Code for Interactions With Companies (4-17-10) Guides the behaviors of specialty societies in relationships with industry Thirty-four signers to date Commitment of the specialty society to adopt policies and procedures consistent with the CMSS Code

29. CMSS Code Principles for Society Interactions  Common Definitions  Independence = Free of Company Influence  Transparency = to Physicians and the Public Disclosure of Corporate Support  Key Leaders Without Relationships

30. CMSS Code  Accepting Charitable Donations No company influence  Awarding of Company-supported Research Grants No company influence  Accepting Sponsorships from Companies No company names on visibility items  Licensing No product endorsements

31. CMSS Code Clinical Practice Guidelines Best evidence No company support or influence Majority of panel without relationships Chair without relationships

32. CMSS Code  Society Journals Editor without relationships Adherence to ICMJE Standards  Advertising No adjacency Adherence to ACCME Standards for Commercial Support

33. CMSS Code  Society Meetings Educational Grants and Society CME  Adherence to ACCME Standards for Commercial Support  No company Input or Influence  No bias in CME  Balanced portfolio of support, including physicians pay for CME Satellite Symposia  Adherence to ACCME Standards for Commercial Support  Evidence-based, peer reviewed presentations  Modification of content of conflicted presenters  Trained monitors  No key leader participation Exhibits  Giveaways of modest, educational value only  No obligate pathway  No key leader participation

34. CMSS Code – Consequences of Violation Voluntary Adherence by Specialty Societies Complaints about potential violations will be directed to the Specialty Society The failure of professional voluntary self- regulation breeds external regulation (see PPSA)

35. What are the consequences of? Serving on a pharmaceutical company speakers bureau? Serving as a consultant to a pharmaceutical company? Serving as faculty in a commercially supported CME program? Attending a commercially supported CME program? Accepting a textbook from a pharmaceutical representative? Accepting research funding from pharmaceutical companies? Patenting a surgical device?

36. What are the consequences of? Serving on a pharmaceutical company speakers bureau?  Disclosure to boards, committees, audiences, and on pharmaceutical company websites  Establishing a paid relationship with a company that may preclude the perception of independence  Exclusion from related CME faculty roles, potentially from practice guideline and performance measure development panels, limitation of NIH role as investigator or reviewer Serving as a consultant to a pharmaceutical company?  Disclosure as above  Establishing a relationship as above  May or may not be excluded from CME, guideline panels, depending on the nature of the consultancy  Potential limitation of NIH role as investigator or reviewer

37. PhRMA Code 7 “Speaker training is an essential activity because the FDA holds companies accountable for the presentations of their speakers.”

38. PhRMA Code 7, cont. “While speaker programs offer important educational opportunities to healthcare professionals, they are distinct from CME programs, and companies and speakers should be clear about this distinction. For example, speakers and their materials should clearly identify the company that is sponsoring the presentation, the fact that the speaker is presenting on behalf of the company, and that the speaker is presenting information that is consistent with FDA guidelines.”

39. PhRMA Code 7, cont. “Beyond providing all speakers with appropriate training, companies should periodically monitor speaker programs for compliance with FDA regulatory requirements for communications on behalf of the company about its medicines.”

40. What are the consequences of? Serving as faculty in a commercially supported CME program?  No consequences, as the relationship of faculty is to the CME Provider, not to the supporting company Attending a commercially supported CME program?  No consequences for attendees, but they should seek and pay attention to faculty and planning committee disclosures of relationships

41. What are the consequences of? Accepting a textbook from a pharmaceutical representative?  Disclosure on company website  State-specific regulations (may or may not be permitted) Accepting research funding from pharmaceutical companies?  Disclosure to boards, committees, audiences, on pharmaceutical company websites  May or may not result in exclusions, depending on whether the research grant went to the physician or the institution which employs the physician

42. What are the consequences of? Accepting a royalty for a drug based on your scientific discovery?  Disclosure to boards, committees, audiences, on pharmaceutical company websites  Establishing a paid relationship with a company that may preclude the perception of independence  Exclusion from related CME faculty roles, and potentially from practice guideline and performance measure development panels Patenting a surgical device?  Disclosure to boards, committees, audiences, on pharmaceutical company websites  Establishing a paid relationship with a company that may preclude the perception of independence  Exclusion from related CME faculty roles, and potentially from practice guideline and performance measure development panels

43. Post-test What agencies’ laws or codes guide the behaviors and relationships of:  Physicians  Physicians with the pharmaceutical and medical device industries  Physician organizations  Physician organizations with pharmaceutical and medical device manufacturers  Pharmaceutical representatives  Pharmaceutical representatives with physicians  Medical device company representatives  Medical device company representatives with physicians  Pharmaceutical and medical device companies  Pharmaceutical and medical device companies with the public (2)  Continuing medical education providers  Academic Medical Centers  Academic Medical Centers with Industry  Residency Programs  Residency Programs with Industry

44. Post-test - answers What agencies’ laws or codes guide the behaviors and relationships of:  Physicians  Physicians with the pharmaceutical and medical device industries - AMA Ethical Opinions  Physician organizations  Physician organizations with pharmaceutical and medical device manufacturers - CMSS Code  Pharmaceutical representatives  Pharmaceutical representatives with physicians - PhRMA Code  Medical device company representatives  Medical device company representatives with physicians - AdvaMed Code  Pharmaceutical and medical device companies  Pharmaceutical and medical device companies with the public (2) - FDA, OIG  Continuing medical education providers  Continuing medical education providers - ACCME Standards for Commercial Support of CME  Academic Medical Centers  Academic Medical Centers with Industry - AAMC Report on Industry Funding of Medical Education  Residency Programs  Residency Programs with industry - ACGME Principles to Guide the relationships Between GME and Industry