CSPI: FDA can manage conflicts better

Conflicts of interest among linkurl:US Food and Drug Administration;http://www.the-scientist.com/article/display/36885/ advisory committees are more easily solved than the agency is letting on, suggests a Washington-based think tank. A linkurl:report;http://www.cspinet.org/integrity/watch/200712031.html#1 issued today (Dec. 3) by the Center for Science in the Public Interest (CSPI) reinterprets an FDA-sponsored linkurl:study;http://www.fda.gov/oc/advisory/ERGCOIreport.pdf on conflicts of intere

Bob Grant
Bob Grant

Bob Grant is Editor in Chief of The Scientist, where he started in 2007 as a Staff Writer.

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Dec 2, 2007
Conflicts of interest among linkurl:US Food and Drug Administration;http://www.the-scientist.com/article/display/36885/ advisory committees are more easily solved than the agency is letting on, suggests a Washington-based think tank. A linkurl:report;http://www.cspinet.org/integrity/watch/200712031.html#1 issued today (Dec. 3) by the Center for Science in the Public Interest (CSPI) reinterprets an FDA-sponsored linkurl:study;http://www.fda.gov/oc/advisory/ERGCOIreport.pdf on conflicts of interest among advisory committee members published in October. CSPI claims that the study, conducted by the Eastern Research Group (ERG), found several suitable, conflict-free replacements for conflicted FDA advisory committee members, showing that assembling committees devoid of conflicts of interest is feasible. But an FDA linkurl:press release;http://www.fda.gov/bbs/topics/NEWS/2007/NEW01744.html issued last month suggested just the opposite: "The report highlights the difficulty of assembling highly qualified experts who are free of conflicts," the release read. The ERG study considered four FDA advisory committees assembled last year. The agency issued 17 members of these committees waivers allowing them to participate as experts despite known conflict...
asily solved than the agency is letting on, suggests a Washington-based think tank. A linkurl:report;http://www.cspinet.org/integrity/watch/200712031.html#1 issued today (Dec. 3) by the Center for Science in the Public Interest (CSPI) reinterprets an FDA-sponsored linkurl:study;http://www.fda.gov/oc/advisory/ERGCOIreport.pdf on conflicts of interest among advisory committee members published in October. CSPI claims that the study, conducted by the Eastern Research Group (ERG), found several suitable, conflict-free replacements for conflicted FDA advisory committee members, showing that assembling committees devoid of conflicts of interest is feasible. But an FDA linkurl:press release;http://www.fda.gov/bbs/topics/NEWS/2007/NEW01744.html issued last month suggested just the opposite: "The report highlights the difficulty of assembling highly qualified experts who are free of conflicts," the release read. The ERG study considered four FDA advisory committees assembled last year. The agency issued 17 members of these committees waivers allowing them to participate as experts despite known conflict of interest. But the ERG study found 30 qualified, conflict-free researchers that could have filled these positions. The ERG authors held that their method of using a simple literature search to find the 30 conflict-free replacements probably underestimates actual conflicts among researchers. The same method identified only 11 of the 17 current FDA committee members with waivers, the study's authors reported. "We conclude that the ability to create a conflict-free panel is speculative, and that, even if possible, recruiting and screening costs would be much higher than current expenditures," the ERG authors wrote, adding that the time required to screen additional candidates could delay FDA decisions on important public health issues. CSPI, however, says that assembling conflict-free FDA advisory panels is well worth the added time and money. Today, CSPI along with the Consumer's Union and the Union of Concerned Scientists sent a letter to FDA commissioner linkurl:Andrew von Eschenbach,;http://www.the-scientist.com/article/display/12978/ urging the agency head to widen the pool of potential advisory committee members. The CSPI is also insisting that the FDA implement a linkurl:draft guidance;http://www.fda.gov/oc/advisory/waiver/COIguidedft.html it floated in March, aimed at prohibiting advisory committee members from voting if they have conflicts or financial interests exceeding $50,000. "While the FDA's proposed guidance doesn't go far enough, this study shows that those barred or restricted under its limited provisions could be easily replaced," wrote Merrill Goozner, director of CSPI's Integrity in Science Project and a frequent contributor to __The Scientist__, in the CSPI report. Congress recently passed legislation that requires the FDA to reduce total conflict of interest waivers by 20 percent over the next five years. This reduction, according to Goozner, falls far short of the vision that his group and other consumer groups have articulated for conflict-free advisory committees.

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