Some Highlights of Institute of Medicine Report on Conflict of Interest in Medical Research, Education, and Practice As Related to Practice Guidelines - PowerPoint PPT Presentation

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Some Highlights of Institute of Medicine Report on Conflict of Interest in Medical Research, Education, and Practice As Related to Practice Guidelines

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Title: Some Highlights of Institute of Medicine Report on Conflict of Interest in Medical Research, Education, and Practice As Related to Practice Guidelines


1
Some Highlights of Institute of Medicine Report
on Conflict of Interest in Medical Research,
Education, and PracticeAs Related to Practice
Guidelines
  • Remarks by
  • Robert Krughoff, President
  • Consumers CHECKBOOK/Center for the Study of
    Services
  • for
  • AHRQ 2009 Annual Conference

2
The IOM Committees 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
  • .

3
Scope
  • Conflicts in academic medical centers, research
    institutions, professional societies, journals,
    etc.
  • How conflicts might affect persons and
    organizations that rely on good research,
    education, care, and guidelinesand how these
    organizations might use their leverage to enforce
    conflict of interest policies
  • Licensing boards, insurers, provider
    organizations, consumer organizations, patients,
    etc.
  • Only considered financial conflicts related to
    drug, device, and biotechnology industries, not
    conflicts related to
  • Payment/reimbursement systems
  • Professional training and preferences
  • Ownership interests in provider organizations
  • Intellectual biases

4
Definition of Conflict of Interest
  • Circumstances that create a risk that
    professional judgments or actions regarding a
    primary interest will be unduly influenced by a
    secondary interest
  • Primary interests of medicine are to
  • Provide beneficial care to patients
  • Conduct valid research
  • Offer excellent medical education
  • Interests of for-profit medical companies are to
  • Produce products that improve health
  • Ensure a financial return to shareholders
  • A conflict of interest is a risk--not necessarily
    the existence of biased judgment or action

5
Tensions and Challenges
  • There are benefits from interactions between
    clinicians/researchers and industry
  • Translation of discoveries into products for
    clinical practice
  • But how big are these benefits, and what if
    the system had not evolved this waynot addressed
    by committee
  • And there are risks of interactions
  • Bias in professional judgment
  • Loss of public trust
  • Committee gave evidence of harm, but could
    not quantify harm
  • New policies on conflicts of interest might have
    unintended adverse consequences

6
Committees Approach to Conflicts of Interest
  • Disclosure an essential but limited first step
  • Assess likelihood and seriousness of harm
  • Determine whether conflict should be prohibited
    or managed, and if managed, how

7
Recommendations on Disclosure/Management
  • 3.1, 3.2 Institutions/organizations that conduct
    medical research, medical education, patient
    care, and practice guideline development should
    adopt and make public conflict of interest
    policies for individuals
  • Create conflict of interest committee to review
    disclosures and determine response to conflicts
    (e.g., eliminate, manage)
  • Make disclosures specific enough to identify and
    assess risks of relationships
  • Avoid unnecessary administrative burdens

8
Recommendations on Disclosure/Management(contd)
  • 3.3 There should be a broad-based consensus
    process to develop standard categories and
    formats for disclosure of financial interests to
    institutions, with the expectation that this
    would lead to common software that individuals
    could use to report for multiple purposes--
  • Reduce burden on individuals who have to report
  • Improve adequacy of information to assess
    relationships and risks
  • 3.4 Congress should require pharmaceutical,
    medical device, and biotechnology companies to
    publicly report payments to physicians and other
    prescribers, researchers, health care
    institutions, professional societies, providers
    of continuing medical education, etc.
  • Should be in a database searchable by name of
    recipient

9
Broader-Disclosure Model
  • Minority view
  • All institutions that will get disclosures should
    require that the individual, using the new
    standardized reporting requirements and software,
    simply do an extra click of the button to send
    to a public database the same information that
    he/she is reporting to an institution
  • Rationale
  • Would include information on patent and equity
    ownership not included in what industry has to
    report
  • Would allow industry reporting to be
    cross-checked against reports of individuals to
    institutions
  • Would reveal how aggressive institutions are in
    requiring reporting and managing and limiting
    conflicts
  • Would not impose significant burden on
    individuals, since only individuals already
    required to report to institutions would be
    required to report the same information publicly,
    and many individuals will have nothing to report

10
Recommendations on Continuing Medical Education
  • 5.3 Consensus development process should be
    convened to develop a new system of funding
    accredited continuing medical education that is
    free of industry influence and provides
    high-quality education
  • Quotation marks here and later are mine to
    highlight ambiguities that trouble me.

11
Recommendations on Medical Practice
  • 6.1 Physicians should
  • Not accept items of material value, or consulting
    arrangements, except when a transaction involves
    payment at fair market value for a legitimate
    service
  • Not meet with sales representatives except by
    documented appointment and at the physicians
    express invitation
  • Not accept ghostwriting
  • Limit acceptance of drug samplesif at all, only
    give to patients who lack financial access to
    medications and only when generic alternatives
    are not available and the medication can be
    continued at little or no cost to the patient for
    as long as it is needed
  • Professional societies and health care
    providers should amend policies to support these
    recommendations
  • 6.2 Companies should have policies and practices
    consistent with these recommendations

12
Recommendations on Practice Guidelines
  • 7.1 Organizations that develop clinical practice
    guidelines should
  • Exclude as panel members individuals with
    conflicts of interest
  • Not accept direct funding of guidelines from
    companies or company foundations
  • Publicly disclose with each guideline their
    conflict of interest policies, procedures, and
    sources and amounts of indirect or direct
    funding for the guideline
  • Report text Some committee members also wanted
    groups that develop guidelines to report publicly
    all their sources, amounts, and purposes of
    funding because industry contributions to general
    revenues (e.g., from journal advertising) could
    also create undue influence. There was not
    consensus on this point.

13
Recommendations on Practice Guidelines(contd)
  • 7.1 contd--In the exceptional situation in which
    avoidance of participants with conflicts of
    interest is impossible because of the critical
    need for expertise, then organizations should--
  • Publicly document that they made a good faith
    effort to find expert panel members without
    conflicts of interest by issuing a public call
    for members and other recruitment measures
  • Appoint a chair without a conflict of interest
  • Limit members with conflicting interests to a
    distinct minority of the panel
  • Exclude individuals who have a fiduciary or
    promotional relationship with a company that
    makes a product that may be affected by the
    guidelines
  • Exclude panel members with conflicts from
    deliberating, drafting, or voting on
    recommendations
  • Publicly disclose relevant conflicts of interest
    for panel members

14
Recommendations on Practice Guidelines(contd)
  • Note the exclusion of panel members with
    conflicts from deliberating, drafting, or voting
    on recommendations.
  • Exclusion is not limited to portions of
    guidelines that relate to the members conflicts.
  • Committees judgment was that if the guideline
    panel would be able to reach judgment without the
    conflicted members deliberation, drafting, or
    voting on a conflict-related issue, then the
    panel could do this on all issuesthat the
    conflicted members role was merely to be a
    convenient source of information and
    understanding/education for other panel members,
    not one of the judges.

15
Recommendations on Practice Guidelines(contd)
  • Report text
  • Committee believed that an end to direct funding
    for guidelines is necessary to avoid the
    conflicts that come from industry financing.
  • An expanded role for public-sector sponsorship of
    guidelines would be desirable, but that issue is
    beyond committees scope.
  • Professional societies could collaborate and
    share costs.
  • Pooling mechanisms might be created to support
    guideline development in broad categories.
  • Committee endorsed a recent IOM report calling
    for Congress to require designation of a single
    entity with the responsibility to--
  • Establish priorities for and manage the
    development of systematic reviews of clinical
    effectiveness
  • Develop standards for such reviews and for
    clinical guidelines
  • Address conflicting guidelines.

16
Recommendations on Practice Guidelines(contd)
  • 7.2 Accrediting and certification bodies, health
    insurers, public agencies, and other similar
    organizations should encourage institutions that
    develop practice guidelines to adopt conflict of
    interest policies consistent with the
    recommendations in this report. Two desirable
    steps are for
  • The National Guidelines Clearinghouse to require
    that all guidelines accepted for posting describe
    (or provide a link to) the developers conflict
    of interest policies, the sources and amounts of
    funding for the guideline, and the relevant
    financial interests of guideline panel members if
    any
  • Accrediting and certification organizations,
    public and private health plans, and similar
    groups to avoid using practice guidelines for
    performance measures, coverage decisions, and
    similar purposes if the guideline developers do
    not follow the practices recommended in this
    report
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