1. Conflict of Interest in Medical Research, Education, and Practice Presentation for Secretary’s Advisory Committee on Human Research Protections July 22, 2009

2. 2 Study origin and funding  Origin: IOM Board on Health Sciences Policy; also inquiries from outside groups about conflict of interest threats  National Institutes of Health, Robert Wood Johnson Foundation, IOM endowment, ABIM Foundation, Greenwall Foundation, Josiah Macy Jr. Foundation, Burroughs Wellcome Fund

3. 3 Charge  Examine conflicts of interest in medical research, education, and practice and in the development of clinical practice guidelines  Develop analyses and recommendations to inform policies to identify, limit, and manage conflicts of interest in these contexts without damaging constructive collaborations with industry

4. Comprehensive scope  Across range of medicine Biomedical research Undergraduate, graduate, continuing education Clinical care (not reimbursement or facility ownership) Practice guideline development  Institutions engaged in these activities AMCs, research institutions, professional societies, patient groups, medical journals, etc.  Supporting organizations Accrediting agencies, insurers, licensing boards, government agencies, etc.

5. 5 Study committee Bernard Lo, MD, ChairRobert M. Krughoff, JD Wendy Baldwin, PhDGeorge Lowenstein, PhD Lisa Bellini, MDJoel Perlmutter, MD Lisa Bero, PhDNeil R. Powe, MD, MPH Eric G. Campbell, PhDDennis Thompson, PhD James F. Childress, PhDDavid Williams, MD Peter B. Corr, PhD Todd Dorman, MDMarilyn Field, PhD Deborah Grady, MD, MPHStudy Director Timothy Jost, JD Robert P. Kelch, MD

6. 6 Study process  6 meetings: November 2007-October 2008  Public meetings with academic leaders, industry, biomedical researchers, professional societies, consumer groups, accreditors, federal agencies  Oral and written statements of views invited from over 60 groups  2 commissioned papers  Peer review of draft report  Public release: April 28, 2009

7. 7 Conflict of interest: definition  Circumstances that create a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest  A risk--not necessarily the existence of biased judgment or action

8. 8 Fundamental assessments  Benefits of interactions between MDs / researchers and industry Translation of scientific discoveries into products for clinical practice  Risks of interactions Bias in professional judgment Loss of public trust

9. 9 Challenges  Evidence for policy making is suggestive rather than definitive  Policies and implementation practices may have unintended adverse consequences

10. 10 Broad messages  Key policy goal: protect integrity of judgment and preserve public trust rather than just remediating problems  Process: engage physicians, researchers, and medical institutions in policy development to strengthen policies  Disclosure: a critical but limited first step for identifying and responding to conflicts of interest

11. Messages (cont’d)  Supporting organizations (e.g., accreditors, public agencies): promote policy action and culture of accountability to sustain professional norms and public confidence  Research: provide stronger evidence base for policy design and implementation  If institutions do not act, pressure for regulation is likely to increase 11

12. 12 Selected recommendations: Individual-level conflicts  3.1, 3.2 Institutions: adopt conflict of interest policies for individuals Make disclosures specific enough to identify and assess risks of relationships Create conflict of interest committee to review disclosures and determine response to conflicts (e.g., eliminate, manage) Avoid unnecessary administrative burdens

13. 13 Selected recommendations: Institution-level conflicts  8.1 Institutions: create board-level policies and procedures to identify and respond to conflicts of interest at the institutional level  8.2 NIH/PHS: develop rules for grantees on institutional conflicts of interest

14. 14 Selected recommendations: Standardize disclosure  3.3 Broad-based consensus process to develop standard categories and formats for disclosure of financial interests to institutions  Goals: Reduce burden on researchers Improve information to assess relationships

15. 15 Selected recommendations: Report company payments  3.4 Congress: require pharmaceutical, medical device, and biotechnology companies to publicly report payments to physicians, researchers, and medical institutions (e.g., AMCs, professional societies, providers of continuing medical education)

16. 16 Selected recommendations: Clinical research  4.1 Research institutions: adopt policy that investigators generally may not conduct research with human subjects if they have a significant financial interest in the outcome of the research  Limited exceptions: investigator essential; conflict managed

17. 17 Nonclinical medical research  Nonclinical research needs more attention as do new models of academia-industry collaboration  Relationships and conflicts still need to be identified and evaluated for risk  NIH role Studies of conflict prevalence and consequences Working groups, case studies

18. 18 Selected recommendations: Medical education  5.1 Academic medical centers: Prohibit gifts, ghostwriting, speakers bureaus Limit drug samples, consulting, sales reps Provide education on conflicts of interest  Rationale Academic mission and hidden curriculum End or restrict relationships with risk but little benefit

19. 19 Selected recommendations: Medical practice  6.1 Physicians should Not accept gifts, ghostwriting, speakers bureaus Limit drug samples, sales reps, consulting  Professional societies and health care providers should amend policies to support these recommendations

20. 20 Selected recommendations: Evidence base  9.2 HHS: Develop research agenda to assess effects of conflict of interest policies Develop stronger evidence base for policies Positive and negative effects NIH, FDA, AHRQ roles