IOM warns about physician-pharma conflicts of interest

A new institute report recommends that physicians accept drug samples only if they distribute them to needy patients.

By , — Posted May 11, 2009

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In recent months, medical schools, the drug industry and Congress have sought to crack down on perceived conflicts of interest between physicians and drug companies. Now the Institute of Medicine has joined the calls for change.

The IOM issued a report April 28 warning that such conflicts could undermine the integrity of medicine, and the agency wants everyone involved in physician-drug industry relationships to rethink how they do business. The new approaches should be crafted with full disclosure at their core, the report said.

Conflicts of interest "erode public trust while providing no meaningful benefits to patients or society," said IOM panel Chair Bernard Lo, MD, professor of medicine and director of the Program in Medical Ethics at the University of California, San Francisco.

The report offers 16 recommendations to avoid conflicts in physicians' offices, biomedical research, medical education, journals, clinical guidelines and institutions. They include adopting conflict-of-interest policies and strengthening existing disclosure policies. The report also recommends that Congress require drug- and device-makers to report on a public Web site payments they make to physicians, researchers and academic health centers, among others.

"This is not a new problem, but it seems to be coming forward with ever-increasing force and perhaps frequency," said IOM President Harvey Fineberg, MD, PhD.

Previously, the Assn. of American Medical Colleges and the Institute on Medicine as a Profession, a nonprofit housed at the Columbia University College of Physicians and Surgeons in New York, issued similar recommendations. But neither group touched on as many areas of potential conflicts as the IOM did in its report.

Amid political and media scrutiny, some medical societies have announced plans to refuse industry money for continuing medical education and branded merchandise handed out at meetings, and many medical centers have implemented wide-reaching disclosure and conflict-of-interest policies. Voluntary drug industry rules took effect in January that bar drug reps from giving doctors pens and notepads, and prohibit meals that are not accompanied by some educational component.

Meanwhile, under the Physicians Payments Sunshine Act, now pending in Congress, doctors who receive $100 or more from an industry firm over the course of a year would have those payments posted to a government-operated Web site.

The IOM report was commissioned by government agencies and private foundations after several high-profile medical ethics breaches were reported in the media. These included failures by physicians to disclose ties with drug companies, the elimination of negative findings in research reports, and illegal payments or gifts to physicians.

Although the report makes recommendations for establishing or strengthening conflict-of-interest policies, it does not forbid all relationships between medicine and industry. Patients can benefit from physician-industry connections that move medical discoveries from research to clinical care, Dr. Lo said.

American Medical Association policy says physicians should refuse gifts that do not benefit patients or are worth more than $100, disclose financial conflicts and refuse company stock when doing clinical research, and never put their financial interests before the welfare of patients.

"The AMA was one of the first organizations to address concerns about the ethical implications of medicine's interaction with industry, and we believe that a transparent relationship, guided by ethics, benefits patients and physicians," Rebecca J. Patchin, MD, chair-elect of the AMA Board of Trustees, said in a statement.

Striking the right balance

The IOM report strengthens the arguments of the various organizations that have called for similar moves, said Howard A. Brody, MD, PhD, director of the Institute for the Medical Humanities at the University of Texas Medical Branch.

But Jerome Kassirer, MD, professor of medicine at Tufts University School of Medicine in Boston and former editor-in-chief of the New England Journal of Medicine, said the report doesn't go far enough. "I would have liked for the panel to say that physicians should take nothing from industry -- nothing," said Dr. Kassirer, author of the book On the Take: How Medicine's Complicity with Big Business Can Endanger Your Health.

Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America, a trade association for many of the large pharmaceutical and biotechnology firms, cautioned against going too far.

"It is important to balance the need to manage potential conflicts of interest against the possibility that overly restrictive policies -- for example, prohibitions on physicians' use of drug samples or the availability of industry funding for CME -- could have negative consequences on patient care," Johnson said in a statement.

While the new report urges physicians to reject offers of meals and personal gifts from industry, IOM panelists said free drug samples could be accepted if they are distributed to needy patients. Panel member Eric Campbell, PhD, associate professor of medicine at Harvard Medical School and director of research at the Institute for Health Policy in Boston, said although physicians shouldn't accept lunch and dinner, they could listen and learn from drug company representatives. But he added that physicians remember that the "information is biased in favor of [the drug companies'] products."

The IOM panel did not forbid industry funding for CME but urged that a new system be developed that is free of industry influence. Panel member Neil R. Powe, MD, MPH, chief of medical services at San Francisco General Hospital, suggested that one new form for CME funding could be industry contributions to "pools of unrestricted funding that don't drive the particular content of that education."

The Accreditation Council for Continuing Medical Education has started seeking ways to reduce industry influence on CME, said Murray Kopelow, MD, the council's chief executive. The council has drafted mechanisms that would allow for CME to be designated as free of commercial support or taught by individuals who earn no money doing promotional work for industry and create an independent entity to pool unrestricted donations to fund CME.

The proposals, open for public comment until May 21, could be adopted by the ACCME at its July board of directors meeting.

Although the IOM report's recommendations center on voluntary solutions to avoid potential conflicts, the authors caution that legislative action remains a possibility. "Concern is growing in the U.S. Congress, state legislatures, federal agencies and elsewhere that stronger measures are needed," they warned.

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Guidelines for reducing conflicts

The Institute of Medicine's new report offers 16 recommendations to reduce conflicts of interest between doctors and the drug industry. Among them:

  • Adopt and implement conflict-of-interest policies.
  • Strengthen disclosure policies and require individuals to disclose financial relationships with pharmaceutical, medical device and biotechnology companies on an annual basis.
  • Restrict participation of researchers with conflicts of interest in research with human participants.
  • Reform financial relationships with industry in medical education.
  • Restrict industry funding and conflicts in clinical practice guideline development.
  • Create board-level responsibility for institutional conflicts of interest.
  • Provide education on conflicts of interest to medical students, residents and faculty of academic medical centers and teaching hospitals.
  • Create a national program that requires pharmaceutical, medical device and biotechnology companies and their foundations to report publicly payments to physicians.

Source: "Conflict of Interest in Medical Research, Education, and Practice," Institute of Medicine, April 28

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New PhRMA rules address conflicts, clinical trials

Clinical investigators no longer can count on trial sponsors to treat them and their families to lavish meals and recreational or entertainment events at fancy resorts, according to a revised set of clinical trial guidelines adopted in April by the Pharmaceutical Research and Manufacturers of America.

In addition to being restricted to "modest meals" under the new PhRMA rules, investigators will be expected to adhere to the International Committee of Medical Journal Editors' stringent guidelines on authorship credit and disclosure of financial conflicts. The changes are meant to address concerns about ghostwritten journal articles and a lack of transparency about industry relationships.

"We are making a serious attempt to tackle serious issues," said Jeffrey K. Francer, PhRMA's assistant general counsel.

The new guidelines, which take effect in October, also require PhRMA member companies to post information about all trials involving "patients" -- i.e., not healthy subjects often used in phase 1 safety trials -- within three weeks to the Web, and summary results of all studies once the drugs are approved or investigation has been stopped.

The National Institutes of Health is considering whether to beef up its clinical trials Web site by requiring that all study results be posted, even before Food and Drug Administration approval (link). Drugmakers say such a rule would endanger their intellectual property and impede innovation.

Ida Sim, MD, PhD, director of the Center for Clinical & Translational Informatics at the University of California, San Francisco, advocates greater clinical trial transparency. She said the PhRMA rules are "vague" and would allow companies to "game the disclosure" by claiming they are continuing to study a drug to resist posting study results.

-- Kevin B. O'Reilly

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External links

"Conflict of Interest in Medical Research, Education, and Practice," Institute of Medicine, April 28 (link)

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