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    Tuesday, June 9, 2009

    NEW MEDICAL CONFLICT OF INTEREST GUIDELINES

    In 2007, nearly half of the $2.54 billion in income for CME providers accredited by the Accreditation Council for Continuing Medical Education (ACCME) was from commercial support (companies with a product in the marketplace); over the past decade, commercial support has quadrupled. The committee found that CME "has become far too reliant on industry funding" and that this funding "tends to promote a narrow focus on products," not "a broader education on alternative strategies for managing health conditions. It concluded "that the current system of funding is unacceptable and should not continue."

    In March 2009, despite increasing pressures for reform the ACCME,announced that it would "not be taking any action to end the commercial support" of accredited CME and affirmed its systems and standards for keeping CME "free of commercial bias."

    As if in response in late April 2009, the Institute of Medicine (IOM) issued a report on conflicts of interest that is notable for its breadth — it covers many aspects of medical research, education, and practice as well as both individual and institutional financial relationships.

    The IOM defined a conflict of interest as "a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest." Secondary interests "may include not only financial gain but also the desire for professional advancement, recognition for personal achievement, and favors to friends and family or to students and colleagues."

    Overview of IOM Recommendations about Conflict of Interest in Medicine.
    • Institutions engaged in medical research and education, clinical care, and the development of clinical practice guidelines should "adopt and implement conflict of interest policies" and "strengthen disclosure policies."
    • Congress "should create a national program that requires pharmaceutical, medical device, and biotechnology companies and their foundations to publicly report payments to physicians and other prescribers, biomedical researchers, health care institutions, professional societies, patient advocacy and disease-specific groups, providers of continuing medical education, and foundations created by any of these entities." Until Congress acts, "companies should voluntarily adopt such reporting."
    • Academic medical centers, research institutions, and medical researchers should "restrict participation of researchers with conflicts of interest in research with human participants." Exceptions "should be made public."
    • Academic medical centers, teaching hospitals, faculty members, students, residents, and fellows should "reform relationships with industry in medical education"; these institutions and professional societies should "provide education on conflict of interest."
    • The organizations that created the accrediting program for continuing medical education and other interested groups should reform the financing system so that it is "free of industry influence, enhances public trust in the integrity of the system, and provides high-quality education."
    • Physicians, professional societies, hospitals, and other health care providers should reform physicians' financial relationships with industry; the same standards should apply to community physicians, medical school faculty, and trainees. Physicians should forgo all gifts and other "items of material value" from pharmaceutical, medical-device, and biotechnology companies, accepting only "payment at fair market value for a legitimate service" in specified situations. Physicians should "not make educational presentations or publish scientific articles that are controlled by industry or contain substantial portions written by someone who is not identified as an author or who is not properly acknowledged." Physicians should "not meet with pharmaceutical and medical device sales representatives except by documented appointment and at the physician's express invitation" and should "not accept drug samples except in certain situations for patients who lack financial access to medications." Until institutions change their policies, physicians and trainees "should voluntarily adopt" these recommendations "as standards for their own conduct."
    • Medical companies and their foundations should reform interactions with physicians — for example, by instituting "policies and practices against providing physicians with gifts, meals, drug samples (except for use by patients who lack financial access to medications), or other similar items of material value and against asking physicians to be authors of ghostwritten materials." Consulting arrangements "should be for necessary services, documented in written contracts, and paid for at fair market value." Companies "should not involve physicians and patients in marketing projects that are presented as clinical research."
    • Groups that develop clinical practice guidelines should restrict industry funding and conflicts of panel members. Various entities, including accrediting and certification bodies, formulary committees, health insurers, and public agencies should "create incentives for reducing conflicts in clinical practice guideline development."
    • The governing bodies of institutions engaged in medical research, medical education, patient care, or guideline development "should establish their own standing committees on institutional conflicts of interest" that "have no members who themselves have conflicts of interest relevant to the activities of the institution."
    • The National Institutes of Health should revise federal regulations to require research institutions to have policies on institutional conflicts of interest, including "the reporting of identified institutional conflicts of interest and the steps that have been taken to eliminate or manage such conflicts."
    • Oversight bodies and other groups should "provide additional incentives for institutions to adopt and implement" conflict-of-interest policies, such as by publicizing the names of institutions that have instituted the recommended policies and those that have not.
    • The Department of Health and Human Services and its agencies should develop and fund research agendas on conflict of interest.

    Adapted from Steinbrook R. NEJM 360;21:2160

    COMMENT:
    On Clinical practice guidelines.
    Perhaps the most dangerous of these comments are that with regard to clinical practice guidelines the IOM found that "the risk of undue industry influence . . . is significant."

    Specific recommendations were made for strengthening conflict-of-interest policies.

    These include a general exclusion of panel members with conflicts of interest, a prohibition on direct funding for guideline development from industry or industry-controlled foundations, and complete disclosure of any remaining financial associations or industry funding.

    In exceptional circumstances "in which avoidance of panel members with conflicts of interest is impossible because of the critical need for their expertise," groups should take measures such as publicly documenting that they had made good-faith efforts to find experts without conflicts, for example, by advertising for members, appointing a chair without a conflict of interest, limiting members with conflicts to "a distinct minority," excluding participants with conflicts from "deliberating, drafting, or voting on specific recommendations," and publicly disclosing the "relevant conflicts of interest of panel members."


    Please remember, as with all our articles we provide information, not medical advice.

    For any treatment of your own medical condition you must visit your local doctor, with or without our article[s]. These articles are not to be taken as individual medical advice.

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