10 Experts on FDA Advisory Panel Supporting COX-2 Inhibitors Had Ties to Pharmaceutical Industry
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 (Kaiser Daily Health Policy Report, 2/22).
Impact of Pharmaceutical Industry Ties
According to the CSPI review, without the 10 committee members with past financial ties to the drugs' makers, the committee would have voted 12-8 to recommend that FDA order the withdrawal of Bextra from the market and 14-8 to recommend that the agency not allow Vioxx not return the market. Those 10 committee members voted 9-1 to recommend that FDA allow Bextra to remain on the market and 9-1 to recommend that the agency allow the return of Vioxx to the market. However, the votes of those 10 committee members would not have affected the recommendation that FDA allow Celebrex to remain on 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. According to the Times, the review conducted by CSPI -- a "frequent critic" of FDA and the pharmaceutical industry -- might "understate the industry ties of the panel participants because some ties may not have been previously disclosed publicly." Common Practice?
Researchers with past financial ties to pharmaceutical companies often serve on FDA advisory committees, the Times reports. Although FDA has sought to "balance expertise ... with potential conflicts of interest," the inclusion of such researchers on agency advisory committees "has long been a contentious issue," according to the Times. Prior to each of the FDA advisory committee meetings on COX-2 inhibitors last week, 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." The FDA secretary also said that the agency "acknowledges that there may be potential conflicts of interest, but because of the general nature of the discussions before the committee, these potential conflicts are mitigated." Reaction
Eight of the 10 committee members with past financial ties to pharmaceutical companies said that their relationships with Pfizer, Merck and Novartis -- which has filed an application for FDA approval of the COX-2 inhibitor Prexige -- did not influence their votes. The other two of those 10 committee members declined to comment on the issue. Some of those 10 committee members said that most or all of the funds that they received from pharmaceutical companies for research "went not to themselves but to their universities or institutions," the Times reports. John Farrar, a neurologist at the University of Pennsylvania and a committee member who has received research funds from Pfizer, said, "I think FDA would have a hard time finding people who are good at what they do who never spoke to a pharmaceutical company." However, Curt Furberg, an epidemiologist at Wake Forest University and a committee member with no past financial ties to pharmaceutical companies, said that he was "uncomfortable with the Pfizer-friendly undertone" at the meetings and raised concerns that some committee member were influenced by such ties. Alastair Wood, an associate dean at Vanderbilt University and chair of the committee, said that FDA should have disclosed the potential conflicts of interest among committee members, adding, "I'm a great believer in letting it all hang out." Officials from Pfizer and Merck said that the companies had no influence over the membership of the FDA advisory committee on COX-2 inhibitors. Additional Reaction
Sheldon Krimsky, a science policy expert at Tufts University, said, "FDA has to work harder to fill panels with people without conflicts, and if they feel they have the best committee, they at least ought to make it transparent," Krimsky said. Daniel Troy, an attorney and former FDA general counsel, said the assumption that agency advisory committee members are influenced by past financial ties to pharmaceutical companies "buys into an overly conspiratorial view of the world" (New York Times, 2/25). Related Articles
AP/Long Island Newsday: AP/Newsday on Friday examined likely "changes in advertising strategies" in the pharmaceutical industry as many experts maintain that direct-to-consumer prescription drug ads "are not doing enough to explain the inherent risk" of medications and a number of studies indicate a "consumer backlash." Although "no one is predicting a major collapse in ad buys," experts expect that prescription drug ad spending growth will decrease in the next few years, AP/Newsday reports (Agovino, AP/Long Island Newsday, 2/25).
Baltimore Sun: The Sun on Friday examined aspirin, at which "some Americans may be taking another look" in response to the recent safety concerns related to COX-2 inhibitors. "We medically know it's as good an anti-inflammatory as any other," Alan Kimmel, a Maryland internist, said, adding, "But it's not sexy, it has no cachet, and it's too inexpensive" (Large, Baltimore Sun, 2/25).
Boston Globe: The Globe on Friday examined how FDA "will be more vigilant in monitoring drug advertising to consumers" in response to the "nearly uniform condemnation" of DTC ads for COX-2 inhibitors by the agency advisory committee. FDA Acting Commissioner Lester Crawford said, "We have to send out letters instructing firms in no uncertain terms to stop this line of advertising and get back to informing the public about the virtues of the drug and the limitations of the drug" (Henderson, Boston Globe, 2/25).
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View drug information on Bextra; Vioxx.
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