Conflict of Interestin Medical Research, Education, and Practice
Presentation for Secretary’s Advisory Committee on Human Research ProtectionsJuly 22, 2009
2
Study origin and fundingOrigin: 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
ChargeExamine 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
Comprehensive scopeAcross 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
Study committee
Bernard Lo, MD, Chair Robert M. Krughoff, JDWendy Baldwin, PhD George Lowenstein,
PhDLisa Bellini, MD Joel Perlmutter, MDLisa Bero, PhD Neil R. Powe, MD, MPHEric G. Campbell, PhD Dennis Thompson, PhDJames F. Childress, PhD David Williams, MDPeter B. Corr, PhDTodd Dorman, MD Marilyn Field, PhD Deborah Grady, MD, MPH Study DirectorTimothy Jost, JDRobert P. Kelch, MD
6
Study process6 meetings: November 2007-October 2008Public 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 papersPeer review of draft reportPublic release: April 28, 2009
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
Fundamental assessments
Benefits of interactions between MDs / researchers and industry• Translation of scientific discoveries into
products for clinical practiceRisks of interactions• Bias in professional judgment• Loss of public trust
9
Challenges
Evidence for policy making is suggestive rather than definitive
Policies and implementation practices may have unintended adverse consequences
Broad messagesKey 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
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
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
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
Selected recommendations:Standardize disclosure3.3 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
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)
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
Nonclinical medical researchNonclinical 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
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
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