April 28, 2009

Panel Seeks Fuller Disclosure of Drug Company Payments

TUESDAY, April 28 (HealthDay News) -- A government panel is calling on Congress to require drug, device and biotechnology companies to publicly report payments they make to certain individuals and institutions, including physicians, researchers, professional societies and patient advocacy groups.

The panel also said there should be a ban on gifts to doctors, limitations on the use of drug samples and a requirement that every institution in the United States engaging in medical research, the practice of medicine or medical education establish conflict-of-interest policies.

The suggestions are among 16 recommendations contained in a report, Conflict of Interest in Medical Research, Education and Practice, released Tuesday by the Institute of Medicine (IOM), part of the National Academy of Sciences. The IOM serves as an adviser to the nation on health matters.

"We're asking for more disclosure in terms of more specifics and more standardization of what gets disclosed," said Dr. Bernard Lo, director of the program in medical ethics at the University of California, San Francisco, and chairman of the IOM panel that prepared the report.

Dr. Peter Lurie, deputy director of the Health Research Group at the Washington, D.C.-based advocacy group Public Citizen, said the report is comprehensive and is a significant step forward.

"It's an acknowledgment of the severity of the conflict-of-interest problem and the degree to which certain cases can pollute every aspect of medicine, from clinical care to research to education," he said.

"I think it's important that patients and consumers know that this report exists," added Linda Golodner, president emeritus of the National Consumers League in Washington, D.C. "And they should put the pressure on professional organizations and societies to understand that they should have good principles in place that avoid conflict of interest."

The IOM committee was convened to address growing concerns over physicians' and researchers' financial ties to drug, device and biotechnology companies. Although these relationships are common in medicine, recent reports have exposed the potential for conflicts that undermine patient care as well as the public's trust in medicine, the committee said.

Though more empirical data is needed, surveys show that existing policies for reporting financial conflicts vary considerably and are not applied consistently, the report noted.

"The public should insist that there be enough disclosure of financial relationships so that they and the people who act on their behalf can judge if there is a risk of too much bias," Lo said.

The panel's recommendations include:

• Banning industry gifts "of material value" given to faculty, medical students, residents and fellows.
• Creating standards for the disclosure of financial relationships with industry.
• Using drug samples only for patients who lack financial access to medicines.
• Barring human research in which researchers have a financial interest in the outcome of the research.
• Generally excluding individuals with conflicts from participating in the development of clinical practice guidelines and discouraging groups that develop guidelines from accepting industry funding.

The panel was particularly concerned about faculty members serving as industry spokespeople, Lo said. "It wasn't good role modeling for the younger doctors," he explained. The panel called for policies that prohibit these experts from making presentations controlled by industry or claiming authorship of ghostwritten articles.

But will the report spur substantive change?

"You know, when I read it I thought, 'Boy, this is going to make difference,'" Golodner said. "I hope those in the profession, the professional organizations, will take it seriously."

Lo said the panel hopes that the recommendations prompt voluntary action. "We think these will work best if doctors as a profession say, 'We need to do more to restore trust,'" he said.

More information

To read the report, visit the Institute of Medicine.

SOURCES: Bernard Lo, M.D., professor, medicine, and director, program in medical ethics, University of California, San Francisco; Peter Lurie, M.D., M.P.H., deputy director, Health Research Group, Public Citizen, Washington, D.C.; Linda Golodner, president emeritus, National Consumers League, Washington, D.C.; Conflict of Interest in Medical Research, Education, and Practice, Institute of Medicine, National Academy of Sciences, Washington, D.C.
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