Reaffirming Integrity and Building Public Trust: Conflicts of Interest Across the Missions

1. Reaffirming Integrity and Building Public Trust: Conflicts of Interest Across the Missions Susan Ehringhaus Association of Medical School Pediatric Department Chairs Savannah, March 8, 2009

2. Popular Press: JAMA, 4/16/08 • “The profession of medicine, in every aspect – clinical, education, and research – has been inundated with profound influence from the pharmaceutical and medical device industries.” • “This has occurred because [we] have allowed it to happen….” • “Primum non nocere . . . also holds true for all involved in medical research, biomedical publication, and medical education.”

3. How Did This Happen?1. How and Where the Research Enterprise Developed • The United States’ historic primacy in research • Building of the research enterprise into higher education, unlike our European peers • Hence, National Institutes of Health, beginning with NCI in 1938, NHI in 1948 • Hence, National Defense Education Act and NASA, 1958

4. 1. The Development of the Research Enterprise, cont’d. • Hence, Bayh-Dole, 1980 • Reinforced the importance – in research and clinical sectors -- of aligning the incentives of the knowledge production sectors with the technology development and manufacturing sectors • Rapid expansion of university/medical school/industry relationships • 80s and 90s hype and fulfillment in the late 1990s and early 2000s • Hence, partial alignment between the academic research community and the commercial by 2000

5. 2. Development of the Patient Care System Over the Past 50 Years • Rapid expansion of the knowledge base/capability of the health care system • Lagging attention to performance of the system as well as its capabilities • Lagging attention to questions of accountability, design, and operation of the system • Cost as % of GDP • Physician-patient relationship has become more symmetrical • Now, broad awareness of the necessity to align incentives among the players in the system and to acknowledge consequences when they aren’t

6. Clergy S&L industry Bankers Accountants Financial Industry Universities, Medical Schools Professorate Cabinet members Nominees for high office CIA/Armed Services Attorneys, Judicial system Physicians 3. Leadership Defaults Among Major Professional Groups

7. 4. Integration of the Health Care System • More integrated health care system rather than an aggregation of separate operations • As system evolves, relationships among different actors also change • Necessity for creating new processes internally for each actor and new methods for alignment among actors • New methods of alignment raise new issues

8. 5. Accumulation of Evidence of Bias in the System • Gifts and favors tend to influence the recipient in favor of the donor (e.g.Dana) • Prescribing patterns are influenced by the receipt of drug samples (e.g.Chren) • People are unlikely to think they’re susceptible to being influenced but suspect their colleagues are (e.g.Dana) • Industry funding of clinical trials is associated with pro-industry results (Wazanza) • Neurobiological (fMRI) evidence suggesting that gifts and sponsorships create reciprocal relationships, operating at the unconscious level (Montague)

9. Current National Context for COI • Macy Foundation Report on CME, Nov. 2007 • Consideration of AMA CEJA Report at AMA Annual Meeting, June 2008; reconsideration in June 2009 • Kohl/Grassley’s Physician Payment Sunshine Act re-introduced in 111th Congress; AAMC endorsement of it • MN, VT, ME, WVA, MA, DC; under consideration in >20 states • Grassley investigations, website, high-profile embarrassment

10. More Context • Federal storm clouds have darkened • DPAs with orthopedic implant companies concerning allegations of violations of anti-kickback statute • OIG investigations of NIH’s oversight of awardees’ compliance with COI regs • Industry responses • Revisions to PhRMA code • BIO statement • AdvaMed code • Voluntary industry disclosures of relationships with physicians • Eli Lilly, Merck, GlaxoSmithKline, Pfizer, Medtronic

11. MedPAC Recommendations • Recommendations to Congress, November 2008 • Manufacturers/distributors of drugs, biologicals, devices, and supplies must report to HHS Secretary their FIs with: • Physicians, physician groups, and other prescribers • Pharmacies and pharmacists • Health plans, benefits managers, and their employees • Hospitals and medical schools • CME sponsors • Patient organizations • Professional organizations • $100 aggregate annual threshold • Publicly accessible, searchable website • Separate reporting system for drug samples

12. How Academic Medicine Has Responded • COIs in research: Newly beefed up policies on COI in research around the country; AAMC-AAU Report • COIs in medical education: Wave of new institutional policies; AAMC TF Report • COIs in CME: • Memorial Sloan-Kettering, Stanford, Pittsburgh • COIs in clinical care • Mayo, Wash U., Stanford, Cleveland Clinic, Penn • COIs in specialty societies • CMSS, NASS

13. AAMC Symposium on the Emerging Science of Influence and Reciprocity, June 2007 • Even small favors can influence choice and brain response in measurable ways • Self interest can bias in unconscious ways • Seek/process information selectively • Lack awareness of effects of self interest • People act unethically beyond their own awareness; “commonality of unintentional corruption” • Gifts/sponsorships create reciprocal relationships

14. COIs in Research: AAMC-AAU Report on COI in Human Subjects Research, 2008 • Three messages • Reaffirmation of 2001-2002 recommendations, with refinements • Necessity for more consistent policies and practices across academic institutions • Time is of the essence in fully implementing effective and comprehensive COI programs

15. AAMC-AAU Report on COI in Human Subjects Research, cont’d. • Notable changes • $0 threshold for reporting to one’s institution • Expanded disclosure requirements • Expanded definition of “compelling circumstances” • Policies on institutional COI should be adopted and implemented within 2 years • New focus on key administrators, e.g. department chairs • Analysis template

16. COIs in Medical Education: AAMC Recommendations, 2008 • AMCs should adopt policies to promote a learning environment that supports professionalism. • To the extent that certain interactions with industry are prohibited within AMCs, they should also be prohibited off-site. • AMCs should expect off-site training facilities to adhere to the standards of the AMC regarding interactions with industry. • Industry shouldn’t invite AMC personnel to participate in activities off-site that would be prohibited on-site.

17. Gifts • AMCs should prohibit the acceptance of any gifts from industry by physicians and other faculty, staff, students, and trainees, whether on-site of off-site.

18. Pharmaceutical Samples*** • Distribution of samples in AMCs (if permitted) should be centrally managed in a manner that ensures timely patient access to optimal therapeutics. • If central management is not feasible or would interfere with patient access, AMCs should consider alternative ways to manage samples that do not involve reciprocal relationships nor carry similar risks to professionalism.

19. Site Access by Pharma. Reps. • Access by pharma reps should be restricted to non-patient care and non-public areas, and should only be by appointment or invitation of the physician. • Involvement of students should only be for educational purposes and only occur only under supervision of a faculty member. • Industry reps who wish to present educational information on products may be invited to do so in structured group settings that provide the opportunity for interaction and critical evaluation.

20. Site Access by Device Manufacturer Reps. • Access to patient care areas should take place only after reps have been appropriately credentialed by AMC and should only be by appointment or invitation of physician. • Reps can’t be present during any patient care interaction unless there is prior disclosure to and consent by the patient, and then only to provide training or assistance with the device. • Student interaction must only be for educational purposes under faculty supervision.

21. Continuing Medical Education*** • AMCs should develop audit mechanisms to assure compliance with ACCME standards. • AMCs should establish a central CME office through which all requests for industry support and receipt of funds are coordinated and overseen. • Any industry-sponsored educational programs should be offered only according to ACCME standards by ACCME-accredited providers.

22. Participation in Industry-Sponsored Programs***** • Except for academic investigators presenting results of their industry-sponsored studies to peers where there is opportunity for critical exchange, AMCs should strongly discourage faculty from participating in industry-sponsored speakers bureaus. • If participation is allowed, AMCs should require full transparency and disclosure to the AMC and when participating in the program. • Payment should be only at fair market value.

23. Industry-Sponsored Programs, cont’d. • AMCs should prohibit faculty, students, and trainees from • Attending industry-sponsored events billed as CME • Accepting payment for attending industry-sponsored meetings • Accepting personal gifts from industry at such events.

24. Industry Funds for Trainees • Industry-sponsored educational funds for trainees • Must be given centrally • Have no quid pro quo • Evaluation/selection of recipients must be the sole responsibility of the AMC.

25. Food • Except for food provided at ACCME-accredited programs and in accordance with ACCME standards, AMCs should establish policies that indicate that industry-supplied food and meals are personal gifts and are prohibited on-site and off-site.

26. Professional Travel • AMC physicians, students, and trainees should be prohibited from directly accepting travel funds from industry, other than for legitimate reimbursement or contractual services.

27. Ghostwriting • AMCs should prohibit physicians, students, and trainees from allowing professional presentations of any kind, oral or written, to be ghostwritten by any party.

28. Purchasing • AMCs should require their personnel with any financial interest in any manufacturer of pharmaceuticals, devices, equipment, or provider of services, to disclose the interests and to recuse themselves from involvement in purchasing decisions relevant to the conflicting interests.

29. COIs in Clinical Practice • Disclosure by physicians • Difficulty in linking physician financial interests with clinical choices • General disclosures about industry relationships in patient literature • Specific disclosures to individual patients? By the physician? • How much information? • Noted in the patient’s record? • If the conflict is above some threshold, should there be an substitute provider? A monitor?

30. COIs in Clinical Practice, cont’d. • Types of interests that may be implicated • Equity holdings (of physicians or hospitals) • Consulting, honoraria, or other payments for services • Royalties from inventions used in practice • Service on scientific advisory boards • Gifts • “Interests” deriving from clinical trial sponsorships

31. Where Do We Go From Here? Greatest challenges for academic medicine in addressing the erosion of public trust

32. What have been the most effective strategies to address the concerns expressed by your most affected constituents?

33. How We Change • Enact rules • Change professional/societal expectations • Educate • Do research; provide evidence • Investigate and enforce • Illuminate; disclose

34. How We Change, cont’d. • Keys to success • Visible, continuing commitment by leadership • Visible attention to our shortcomings • Non-anxious presence • Engaging with our publics • Inculcating new standards requires modeling new standards • Alignment: Are particular relationships with industry serving the goals we say we are committed to?

35. What’s Next? • More revelations from Grassley and Physician Payment Sunshine Act • Changes in federal regulations governing research – ANPRM and town hall meetings; accreditation? • Effects of economic downturn and ARRA on industry relationships with schools and faculty • IOM Report • Roll-out of major new AAMC initiative focused on integrity • Development of national standards on COI in clinical practice • Components include development of standards, services, activities • Engaging with the public in new ways, talking points

36. Closing Thoughts • AMCs must have relationships with industry. • However stringent the regulations, COI violations and lapses will continue to occur. • Overzealous regulation could interdict productive relationships between industry and academic medical centers. • Our task is to ensure that we have the right policies and processes in place to manage these relationships responsibly, in light of what we know about influence and in light of our role as stewards of public money and private and public trust.

37. Key Questions: • How do we best model appropriate relationships for the next generations of medical students and biomedical scientists? • What else should we do to regain the confidence and trust of the public in our ability to maintain principled relationships with industry? • What steps should we take to better inform our publics about the value of principled relationships with industry?