Conflict of Interestin Medical Research, Education, and Practice

Presentation for Secretary’s Advisory Committee on Human Research ProtectionsJuly 22, 2009

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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

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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.

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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