Grassley Requests Information on FDA’s COX-2 Inhibitor Panel’s Financial Ties to Industry
Sen. Chuck Grassley (R-Iowa) on Friday sent a letter requesting information on the drug industry ties of members of an FDA joint advisory committee on the safety of COX-2 inhibitors, saying that a report last week on potential conflicts of interest has "marred" the members' recommendation to keep the painkillers on the market, the Los Angeles Times reports (Alonso-Zaldivar, Los Angeles Times, 2/26). The New York Times on Friday reported that 10 of the 32 advisory panel members have recent financial ties -- ranging from research projects to speaking fees -- to manufacturers of COX-2 inhibitors.
The panel earlier this month voted:
- 31-1 to recommend that FDA allow Celebrex, manufactured by Pfizer, to remain on the market;
- 17-13 -- with two abstentions -- to recommend that FDA allow Bextra, also manufactured by Pfizer, to remain on the market; and
- 17-15 to recommend that FDA allow Vioxx, manufactured by Merck, to return to the market.
Among the 30 votes of those 10 committee members, 28 favored COX-2 inhibitors, compared with 37 of 66 votes among other committee members. Prior to each meeting of the advisory committee, which included members of FDA's drug safety and arthritis panels, an agency secretary read a statement to absolve the potential conflicts of interest among committee members because the meetings involved "issues of broad applicability and there are no products being approved" (California Healthline, 2/25).
Grassley, who is reviewing FDA's drug safety monitoring, wrote in his letter, "Unfortunately, the votes of the joint advisory committee are now, justly or unjustly, tainted." He added, "The failure to fully disclose that joint advisory committee members had ties to the drug industry sows more seeds of doubt" (Los Angeles Times, 2/26).
Sen. Edward Kennedy (D-Mass.) also responded to the report by advocating full disclosure of any conflicts of interest among FDA panel members, CQ HealthBeat reports. "The revelations about hidden conflicts of interest among members of the committee that reviewed Vioxx, Celebrex and Bextra emphasizes the need to restore public confidence in the FDA and its ability to protect the public health and safety of the American people," Kennedy said.
He added, "Minimizing conflicts of interest and full and complete disclosure of conflicts on public advisory committees is just one part of the more transparent FDA that the American people need and deserve" (CQ HealthBeat, 2/25).
Panel members disputed the impact of financial links to the drug industry, and some said the committee was more divided between doctors who had treated arthritis patients and wanted to keep COX-2 inhibitors on the market and those who were more concerned with "broader questions of patient safety," the Los Angeles Times reports. The arthritis panel members voted 7-0 to keep Bextra on the market and 6-1 to allow a possible return for Vioxx. Drug safety panel members voted 7-2 against Bextra and 5-5 on Vioxx's return to market.
John Farrar of the University of Pennsylvania, who is one of the 10 panel members with industry ties noted in the report, said, "I think what is likely to have affected the vote is a difference in perspective between physicians who deal with patients and those who deal primarily with safety issues" (Los Angeles Times, 2/26).
Panel member Susan Manzi of the University of Pittsburgh said she thought the vote "was perfectly compatible with the evidence," adding that she was unaware of any financial links that should have disqualified members from the panel. While Manzi said FDA should have disclosed the members' potential conflicts of interest prior to the hearings, she did not think the agency's decision to withhold that information should tarnish the panel's recommendations (Snowbeck, Pittsburgh Post-Gazette, 2/26).
FDA on Friday said that the agency had screened panel members along "the same strict ethics guidelines FDA applies to all its advisory committees" (CQ HealthBeat, 2/25). The Los Angeles Times reports that, according to FDA, "several prospective members were disqualified," and those who were approved were judged to have "scientific expertise that outweighed potential conflicts" of interest (Los Angeles Times, 2/26).
Sheila Dearybury Walcoff, FDA's associate commissioner for external relations, said, "This transparent process requires the agency to carefully weigh any potential financial interest with the need for essential scientific expertise in order to protect and advance public health" (CQ HealthBeat, 2/25).
However, CSPI's Merrill Goozner noted that the agency usually reveals its panel members' potential conflicts of interest at the outset of hearings. Goozner added that the 10 panel members with recent financial ties to the drug industry should have been disqualified from the committee, saying, "If you have a current grant or in the last couple years have done work for a pharmaceutical company, it's almost like you're still beholden to them, or you want more grants from them" (Pittsburgh Post-Gazette, 2/26).
The San Francisco Chronicle on Sunday examined how COX-2 inhibitors might "go down in history as a classic example of the danger posed by aggressive industry promotion of prescription drugs to both patients and doctors." According to the Chronicle, some experts have said the FDA advisory committee's recommendation that the agency ban direct-to-consumer advertisements for COX-2 inhibitors has "delivered a harsh lesson -- that the FDA needs to change the way drug makers launch their new products." Some "people doubt the agency has the authority to limit consumer advertising," but some former FDA officials maintain that the agency "has the power it needs" to implement such a ban, the Chronicle reports.
According to the Chronicle, "The scientific controversy over the COX-2 drugs is by no means over. More studies are planned, and some FDA safety advisers have raised the point that little is known about the possible cardiovascular risks of some of the other painkillers used as alternatives." The Chronicle also profiles the recent history of COX-2 inhibitors and direct-to-consumer ads for the medications (Tansey, San Francisco Chronicle, 2/27).
The Contra Costa Times on Sunday profiled David Campen, medical director of Kaiser Permanente's Northern California pharmacy benefits, who last year decided to conduct the "definitive study on Vioxx" that led Merck to voluntarily withdraw the drug in late September 2004.
Campen said that he has "concerns over [the FDA panel's recommendation] and whether or not you can adequately control the risks associated with these drugs" (Silber, Contra Costa Times, 2/27).
ABCNews' "World News Tonight" on Friday reported on the FDA advisory panel members' links to the drug industry (McKenzie, "World News Tonight," ABCNews, 2/25). In addition, ABCNews Medical Editor Dr. Tim Johnson also discussed the advisory panel (Johnson, "World News Tonight," ABCNews, 2/25).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.