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December 3, 2007

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Despite Official Spin, Report Shows FDA Can Easily Find Experts Without Conflicts of Interest

Science Groups Urge Agency to Adopt Restrictions on Conflicted Experts

Two weeks ago, the Food and Drug Administration claimed a new report prepared by the Eastern Research Group (ERG) showed it would be difficult to create advisory committees free from conflicts of interest and that advisers granted conflict-of-interest waivers have greater expertise than those without conflicts of interest. However, an independent analysis of the data in the study shows just the opposite, according to the Center for Science in the Public Interest (CSPI), who, with other prominent science and consumer groups, is today urging the FDA to adopt the conflict-of-interest guidelines the agency published last March. Those guidelines would ban anyone with greater than $50,000 a year in financial ties to industry from advisory committees and deny a vote to anyone with lesser conflicts.

For each of the four advisory committees analyzed in the study, it would have taken a single FDA official just one week to replace all the advisers who had conflicts of interest with experts who do not have conflicts of interest, according to CSPI's analysis of the ERG data. Moreover, the FDA would be able to choose from nearly two potential unconflicted experts for every open slot. And, based on the same criteria for the expertise of potential committee members used in the study, these easily identifiable unconflicted experts would be more qualified than the ones eventually chosen, whether they had conflicts of interest or not. CSPI's analysis of the ERG report was first published in its Integrity in Science Watch newsletter.

"The FDA's study shows what consumer groups have been arguing all along: When setting up advisory committees, the FDA is ignoring many of the nation's most highly qualified experts who do not have conflicts of interest," wrote the groups, which included CSPI, Consumers Union, Union of Concerned Scientists, Center for Medical Consumers, the National Physicians Alliance and U.S. PIRG, in a letter to FDA Commissioner Andrew von Eschenbach.

"While the FDA's proposed conflict-of-interest guidance doesn't go far enough, its own study shows that those barred or restricted from voting under its limited provisions could be easily replaced," said Merrill Goozner, director of CSPI's Integrity in Science Project. "Choosing well-qualified advisers without conflicts of interest instead of conflicted experts will strengthen the nation's food and drug safety system."