FDA: Advisory Committees Tied to Drug Industry

      More than half of the experts hired to advise the FDA on pharmaceutical safety and effectiveness have financial ties to the drug industry, USA Today reports. According to a USA Today survey, "FDA advisory committees consist almost entirely of pharmaceutical industry consultants and researchers," and "[e]ven consumers' and patients' representatives on the committees often receive drug company money." Advisory members on the 18 committees serve four-year terms and "play a crucial role" in almost every step of drug regulation by advising the FDA as to which drugs should be approved and how the drug industry should be regulated. Members' opinions carry a significant amount of weight with the government organization. For example, the FDA recently has followed every advisory committee recommendation to approve or reject a medicine, except once, when the panel voted against approving Relenza. Votes by committee members carry hefty financial leverage -- a committee vote can "add or subtract hundreds of millions of dollars" from a pharmaceutical company's stock market value. Legislation requires the FDA to screen all committee members for "financial conflicts" -- including stock ownership, consulting fees, research grants, a spouse's employment and payments for speeches and travel -- that may have a "direct and predictable effect" of causing a committee member financial gain or loss. However, the FDA "routinely" grants waivers allowing committee members with financial conflicts to participate in committee meetings. The survey found that between January 1998 and June 30, 2000:

• The FDA granted 803 full or limited conflict of interest waivers to committee members. Seventy-one other times, members had conflicts that did not require a waiver. There was no conflict of interest in the remaining 746 member appearances.
• In 146 of the 159 meetings, at least one committee member had a financial stake in the topic under review. At 88 of those meetings, at least half of the members had financial interests in the debated topic.
• At the 57 meetings on regulatory policy, members had conflicts 91% of the time.
• At the 102 meetings involving specific drugs, 33% of the members had a "direct financial stake" in the outcome.
• Conflicts "are most common" on committees that review heart medicines: 48% of experts on those committees had financial conflicts.

Debates and Dilemmas
      Many of the country's top researchers participate on these advisory committees, and the FDA stated that granting waivers allows the government to utilize some of the nation's leading scientific experts -- many of whom do work for the drug industry. Consumer advocacy groups, however, are wary of the system, arguing that members with financial interest should not be allowed to vote in committee decisions. Larry Sasich, a pharmacist with Public Citizen's Health Research Group, (an organization founded by Green party presidential candidate Ralph Nader) said, "It's outrageous that the pharmaceutical industry's influence is so great that even some consumer representatives are on drug companies' payrolls." Milton Packer, chair of the Cardiovascular and Renal Drugs Advisory Committee, countered the charge, stating that he "doesn't believe that financial conflicts distort the recommendations of advisory committees." Packer also pointed out that mergers and consolidation in the drug industry have "increased the potential for conflicts" since fewer companies exist and nearly all produce heart drugs. Pharmaceutical industry influence on FDA committees will become even greater later this year as the FDA will follow a 1997 law requiring it to add official industry representatives to the committees. The representatives will participate in meetings and deliberations, but will not be allowed to vote (Cauchon, 9/25).