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September 12, 2007

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Physicians' Letter to Kennedy, Dodd

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Physicians Urge Kennedy, Dodd to Support Curb on Financial Conflicts of Interest on FDA Advisory Committees

WASHINGTON—Today nine prominent physicians, including two former editors of the New England Journal of Medicine, are calling on Senators Edward M. Kennedy (D-MA) and Christopher J. Dodd (D-CT) to limit the number of industry-connected scientists who may serve on Food and Drug Administration advisory panels.

The two Senators are among the conferees trying to reconcile differences in the drug safety bills that have passed each chamber, including differences on how many waivers the FDA can grant of its conflict-of-interest rules. While the House version of the bill limits the FDA to one waiver per committee, the Senate, on a tie vote, defeated an amendment with identical language. Senators Kennedy and Dodd were among those voting no, so the nine doctors are urging the Senators to reconsider their opposition.

“Allowing conflicted members of an advisory committee to vote can have serious public health consequences,” wrote the physicians, citing the Vioxx scandal in which 10 of 32 scientists charged with evaluating the safety of Vioxx had ties to manufacturers of that or other Cox-2 painkilling drugs.

“It is possible to find unconflicted experts. The FDA could choose its committee members from among the 123,000 faculty at the 125 medical schools in the United States and public health experts at other federal agencies such as the National Institutes of Health, the Centers for Disease Control, and the Veterans Administration,” wrote the physicians, who included Dr. Marcia Angell of Harvard Medical School, Dr. Jerome P. Kassirer of Tufts Medical School, and seven others.

The nonprofit Center for Science in the Public Interest also supports the House-passed limit on conflicts of interest and has separately called on Senators Kennedy and Dodd to support it.