In deciding whether pharmaceuticals are fit for prescribing to patients, the Food and Drug Administration uses agency scientists to review the voluminous submissions from sponsoring companies. For about a third of new drugs, the agency also convenes a meeting of an advisory committee comprised of outside experts whose opinions are expected to be impartial and in the interests of the public health.
Anecdotal evidence suggests that financial conflicts can affect a committee vote. In 2005, the FDA convened a meeting to discuss the toxicity of the COX-2 inhibitors Vioxx, Celebrex, and Bextra. Had the committee members with ties to industry been precluded from voting, the committee would have voted against continued marketing for Vioxx and Bextra; instead all 3 drugs received favorable votes.[2,3]
In April, we published a study in The Journal of the American Medical Association that examined the prevalence and consequences of financial conflicts at these meetings over 4 years. At least 1 advisory committee member had a financial link to the drug's maker or a competitor in 73% of meetings. Seventy-two percent of members reported no conflicts. Clearly, there is little difficulty finding conflict-free scientists.
Excluding members with conflicts would have yielded votes less favorable to the drug being considered, but there were no COX-2-like examples in which excluding conflicted advisory committee members would have reversed the overall outcome. However, committee members with conflicts were 10% more likely to favor the drug being considered.
Simply disclosing conflicts is not sufficient. Only 1% of members were recused from meetings in our study, even though 23% of contracts and grants were worth more than $100,000 and 30% of investment conflicts exceeded $25,000. Such degrees of conflict should lead to the automatic exclusion of the member. Until the disclosure process is made more detailed and more conflicted members excluded, Americans will continue to suspect that drug makers are contaminating FDA Advisory Committee recommendations.
That's my opinion. I'm Dr. Peter Lurie, Deputy Director, Public Citizen's Health Research Group.