FDA Advisory Committee Votes Raise Questions About Industry Ties

Critics are questioning the Food and Drug Administration's (FDA) handling of conflicts of interest after a recent advisory committee vote on the safety of certain painkillers, including Vioxx and Bextra. The 17-15 and 17-13 votes, with two abstentions, in favor of Vioxx and Bextra, respectively, have sparked concerns about the influence of pharmaceutical companies on the agency's decisions. While the FDA typically follows the recommendations of its advisory committees, critics argue that the presence of industry ties among panel members undermines the integrity of the process.

Key Takeaways:

• 10 panelists on the FDA advisory committee had received speaker's honoraria, consulting fees, or research money from Merck (maker of Vioxx), Pfizer (maker of Bextra and Celebrex), or Novartis, raising questions about their impartiality.
• Most panelists with industry connections voted in favor of continued marketing of Bextra and Vioxx, leading some to accuse the FDA of being "too cozy" with drugmakers.
• FDA critics, including Sen. Chuck Grassley, R-Iowa, argue that the agency is unable to locate experts without industry connections, raising concerns about the pool of eligible panelists.
• The FDA claims to have screened COX-2 advisory panel members for conflicts of interest according to its "strict ethics guidelines," but critics remain skeptical.
• Only one panelist, Arthur Levin of the Center for Medical Consumers, voted against keeping Celebrex on the market.

Statistics:

• 10 panelists had industry ties with Merck, Pfizer, or Novartis
• 17-15 vote in favor of Vioxx
• 17-13 vote in favor of Bextra, with two abstentions
• 32-1 vote in favor of continued marketing of Celebrex
• Chronic pain affects approximately 86 million people in the U.S. (HHS, 2020)

Sources:

• "Critics Accuse FDA of Being Too Cozy with Drugmakers" by Tim Rutten, Los Angeles Times
• FDA advisory committee voting records (March 2005)
• Center for Science in the Public Interest report on COX-2 advisory panel members' industry ties