Nine prominent physicians, including two former editors of the New England Journal of Medicine, wrote to Senators Edward M. Kennedy (D-MA) and Christopher J. Dodd (D-CT) urging them to vote to limit the number of industry-connected scientists who may serve on Food and Drug Administration advisory panels. Kennedy and Dodd are among the congressmen trying to resolve differences in the drug safety bills that have gone through both houses of Congress.
The physicians wrote:
“Allowing conflicted members of an advisory committee to vote can have serious public health consequences. For example, in early 2005 a FDA advisory committee reviewed the safety of COX-2 inhibitors and concluded that all three of these drugs, including Vioxx, were safe enough to keep on the market. Ten of 32 scientists on that panel had financial ties to manufacturers of the drugs. Had their votes been eliminated, two of the three drugs in that class would have ben voted down by the panel. (Vioxx was, of course, voluntarily withdrawn from the market by Merck in September 2004 because of safety concerns).Posted by schwitz at September 13, 2007 08:18 AM | TrackBackIt is possible to find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 (“NIH�), the Centers for Disease Control, and the Veterans Administration. The NIH’s Office of Medical Applications of Research and the Agency for Healthcare Research and Quality’s U.S. Preventive Services Task Force bar any conflicted scientists from serving on the panels that develop consensus statements on the implications of clinical trial evidence. The Center for Evidence- Based Policy at Oregon Health Sciences University bars any conflicted expert from its analysis of clinical trial evidence to determine what drugs, biologics, and devices provide the best medical outcomes; this evidence is then turned over to states for use in establishing what Medicaid will pay for, among other uses."