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Institute of Medicine: We Need Mandatory Reporting on Doctor Conflicts of Interest

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In the wake of a recent Massachusetts state ban on drug industry gifts to doctors and a Cleveland Clinic mandate requiring all its doctors to publicly report their financial ties to drug companies, the Institute of Medicine (IOM) has issued a report addressing conflicts of interest in areas of medical research, education, and practice and how they should be dealt with.

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." The primary interests of concern include "promoting and protecting the integrity of research, the welfare of patients, and the quality of medical education." 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." -Robert Steinbrook, New England Journal of Medicine

Functionally, doctors all over the country face questions over conflict of interest whenever they accept payments and perks received from the drug industry, for services ranging from presenting papers to co-authoring drug studies to attending drug-sponsored fancy dinners—or sometimes just for trying out a company’s product on patients. Strong evidence suggests that even small gifts like pens and coffee mugs exert a powerful psychological effect on doctors’ prescribing behavior. A 2003 study coauthored by Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania,and published in the American Journal of Bioethics found “indisputable [evidence] that small gifts had a tremendous power in influencing favorable attitudes toward products.”

In light of findings like these, the IOM is recommending that Congress enact legislation similar to and broader than the Physician Payments Sunshine Act, that will drug and medical companies to publicly and comprehensively report their payments to doctors and various other groups on a “searchable public website that allows the aggregation of all payments made to an individual or organization”; this applies to “not only payments to physicians but also those to nonphysicians who prescribe medications, biomedical researchers, and a variety of organizations including health care institutions, professional societies, CME providers, and patient advocacy and disease-specific groups.”

This is great news, and the best part is that our Congress might actually take the IOM’s advice. Read on for specifics about the IOM’s recommendations:

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." They and other interested organizations (such as accrediting bodies, health insurers, consumer groups, and government agencies) should standardize the content, formats, and "procedures for the disclosure of financial relationships with industry."

• 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 financial conflicts of interest in research with human participants." Exceptions "should be made public" and occur only if a conflict-of-interest committee "determines that an individual’s participation is essential for the conduct of the research" and if there is "an effective mechanism for managing the conflict and protecting the integrity of the research."

• 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 that 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 doctors 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. -NEJM