Medical Panel Rules Called Too Restrictive; Report Weighs in on Conflicts of Interest

Article excerpt

Byline: Andrew Entzminger, THE WASHINGTON TIMES

The conflict-of-interest policies in the medical profession are coming under fire as too stringent and as impeding medical progress, a claim the Food and Drug Administration dismisses as a misunderstanding of its rules.

In a report published last week by the conservative-leaning Manhattan Institute, New York University law professor Richard Epstein said conflict-of-interest rules have too many restrictions that prevent informed and knowledgeable people from sitting on medical school faculty and panels that rule on drug licensing.

If you want pure information, you get less information. There's much less tolerance of the conflicts than there used to be, said Mr. Epstein, whose report calls for more lenient regulations on whether medical professionals who have consulted for pharmaceutical companies can hold such posts.

However, other scholars said the conflict-of-interest laws don't go far enough and that reports of undermanned or uninformed federal advisory panels are exaggerated.

The kind of expertise you need in serving on a federal advising committee is not necessarily the same kind of expertise you need to help a pharmaceutical company develop a drug, said Sheldon Krimsky, an adjunct professor in Tufts University School of Medicine's Department of Public Health.

The 49 Food and Drug Administration advisory committees have 177 vacancies, including 10 openings on the 13-member Drug Safety and Risk Management Advisory Committee, six unfilled slots on the 14-member Nonprescription Drugs Advisory Committee and six vacancies on the 26-member Pharmaceutical Science and Clinical Pharmacology Advisory Committee.

However, Jill Hartzler Warner, the FDA's acting commissioner for special medical programs, said the vacancies have nothing to do with conflict-of-interest rules, which she said are applied piecemeal for each particular vote. A member judged to have a conflict of interest on a specific drug or treatment is prevented from voting only on that issue. Under some circumstances, the panel member can attend the meetings on the issue and can vote on other drugs or treatments.

We screen each member in advance of each meeting for financial interests related to the topic(s) of the meeting, she said.

Mr. …