FDA did not disclose conflicts in Vioxx, Celebrex, Bextra hearings
Health advocates have urged the Food and Drug Administration (FDA) to stop placing scientists with direct financial conflicts of interest on its advisory committees, and to limit the number of individuals with any industry ties to no more than half of any committee. In a letter to Acting FDA Commissioner Lester Crawford, the groups said that the agency failed to comply with the Federal Advisory Committee Act (FACA) when it assigned scientists with ties to manufacturers of arthritis pain drugs known as Cox-2 inhibitors to serve on a panel charged with evaluating those drugs. (Related article: FDA panel recommendations in doubt after conflicts of interest reported)
Last month, the Center for Science in the Public Interest (CSPI) found that of 32 experts serving on the FDA’s Arthritis Drug and Drug Safety Advisory Committee, 10 had received funding from Pfizer, Merck, or Novartis. Pfizer makes Celebrex and Bextra, Merck makes Vioxx, and Novartis is developing a similar drug (Prexige or lumiracoxib). At the end of the three-day meeting designed to assess the cardiovascular risk presented by these drugs, the panel voted to keep all of those drugs on the market. But according to The New York Times, the committee would have recommended that Bextra and Vioxx be withdrawn were it not for the votes of scientists with conflicts. (Related articles: Vioxx sales allowed to resume in the US and Celebrex and Bextra to stay on the market in the US)
“The FDA is the ultimate arbiter of the safety and efficacy of industry products,” states the letter signed by CSPI, the National Women’s Health Network, the Center for Medical Consumers, the U.S. Cochrane Center Consumer Coalition, and eight other health-advocacy groups. “[FDA] relies on its advisory committees for guidance. No one financially connected to the firms whose products are up for consideration should be allowed to vote on what that guidance should be.” (Related article: Americans' trust in FDA falling after Vioxx recall)
CSPI and the groups are not asking the FDA to exclude scientists with any corporate ties from serving on committees, just those currently or recently employed by companies with a direct stake in the committee’s proceedings. The groups urged the FDA to stop granting waivers that allow conflicted scientists to serve. In the case of the Cox-2 review panel, the FDA issued a blanket waiver summarily covering every scientist on the panel. None of those scientists’ financial ties to industry were disclosed prior to or during the meeting. It is interesting to mention the case of famous cardiologist Dr. Eric Topol, an early critic of Vioxx, who was widely criticized after it was disclosed that he was an advisor to a hedge fund that shorted Merck shares. As soon as these disclosures came to the knowledge of Dr. Topol, he immediately stopped working with the fund.
“The FDA has become so reliant on scientists connected with industry that it routinely grants waivers for conflicts of interest, not just in exceptional cases,” said Amy Allina, program director of the National Women’s Health Network. “FDA’s unquestioning acceptance of this degree of industry influence has had a damaging effect on the quality of advice it gets from advisory committees and also has undermined the public’s faith in the advisory process.” (Related article: FDA continues to side with Merck and Pfizer in issues involving Vioxx, Celebrex, and Bextra)
The groups are also calling for greater transparency and for greater opportunities for public participation in the federal advisory committee process. They want the FDA to post biographies of proposed committee members online 30 days before committee meetings instead of 72 hours before, and to allow the public 20 days to comment on the proposed roster. The groups say that FDA’s practices lag behind those of the Environmental Protection Agency and the National Academies. (Related article: FDA did not do its job in Vioxx recall case)
“No one would consider a jury’s verdict credible if a number of jurors had taken money from the defendant,” said Merrill Goozner, director of the Integrity in Science project at CSPI. “If the FDA wanted to restore public confidence in its decisions about the safety of food ingredients, drugs, and medical devices, it should reform the advisory committee process. I hope members of the Senate ask Acting Commissioner Crawford about these issues during his confirmation hearings next week.” (Related article: Merck and FDA haggled for months over label changes to highlight risks of Vioxx)
Other signatories to the letter include the Reproductive Health Technologies Project, Breast Cancer Action, the Annie Appleseed Project, National Consumers League, the National Autism Association, SafeMinds, the National Research Center for Women and Families, and Our Bodies, Ourselves.
Recommended article: Americans abandoning Vioxx, Celebrex, and Bextra after losing confidence in the safety of Cox-2 drugs
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