COX-2 Cmte. Conflict Of Interest Disclosure Is Subject Of Grassley Inquiry
This article was originally published in The Pink Sheet Daily
Executive Summary
The Senate Finance Committee chairman asks FDA Acting Commissioner Crawford to respond to questions about "the appearance" of a conflict of interest for many of the advisory committee members due to alleged ties with industry. Grassley asks for responses from the agency by March 11.
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FDA should provide additional disclosure on the COX-2 advisory committee members' potential conflicts of interest because they could have influenced the outcome of the meeting, Senate Finance Committee Chairman Chuck Grassley (R-Iowa) said. In a Feb. 25 letter to FDA Acting Commissioner Lester Crawford, Grassley cited a same-day New York Times article that suggested 10 members of the Arthritis Drugs/Drug Safety & Risk Management Advisory Committees may have financial ties to COX-2 manufacturers and that FDA downplayed those ties. "Unfortunately, the votes of the joint advisory committee are now, justly or unjustly, tainted," the letter states." The committees voted 31-1 that Pfizer's Celebrex (celecoxib) has a risk/benefit profile that justifies continued marketing (1 (Also see "Pfizer Celebrex Continued Marketing Supported By FDA Cmte." - Pink Sheet, 18 Feb, 2005.)). The committee decided in favor of continued marketing of Pfizer's Bextra (valdecoxib) in a 17-13 vote with two abstentions. In a 17-15 vote, the committee concluded that Merck's Vioxx (rofecoxib) could again be marketed (2 (Also see "Vioxx And Bextra Get Split Votes From FDA Cmte. On Marketing" - Pink Sheet, 18 Feb, 2005.)). Grassley sent FDA questions and requests for more information on nine issues, asking for a response by March 11. "Please explain FDA's decision to waive conflicts of interest when it is clear that any recommendation from the joint advisory committee would directly affect the financial interests of Merck and Pfizer," Grassley said. Grassley also asks Crawford to disclose further information on how FDA selected members of the committee, how the agency selected consultants serving on the panel and what screening process the agency has for detecting potential conflicts of interests. "Was each FDA consultant and member of the joint advisory committee specifically requested to disclose to the FDA his/her relationship or association with ANY drug company? If not, why not? If any such relationship or association was disclosed, please identify each consultant/member and please be sure to describe that relationship or association in detail," Grassley said. FDA is asked to provide the Finance Committee "with the voting results of each measure voted upon by the joint committee, including who voted in favor or against each measure cross referenced with that member's/consultant's conflict." - Lee Kalowski |