Public Citizen exposes frequent conflict-of-interst at FDA advisory c'tee meetings

In the USA, conflicts of interest at drug advisory committee meetings for the Food and Drug Administration are common and often of considerable monetary value, but rarely result in recusal, finds a study conducted by the consumer action group Public Citizen and published in The Journal of the American Medical Association. The study details financial conflicts of interest between advisory committee members and the companies producing the drugs they evaluated; it also examines conflicts with competing companies. It exposes a weak but statistically-significant relationship between certain conflicts and votes in favor of the drug under consideration.

The study appears in the April 26 issue of JAMA and was authored by Peter Lurie, Cristina Almeida, Nicholas Stine and Sidney Wolfe, all from Public Citizen's Health Research Group, and Alexander Stine of the Department of Earth and Planetary Science at the University of California, Berkeley.

The FDA's Center for Drug Evaluation and Research approves 25-30 New Chemical Entities each year, often relying in its decision-making on the advice of outside advisory committee members and agency-invited voting consultants. In September 2001, Public Citizen says it threatened a law suit against the FDA to force it to disclose detailed information about the financial interests of committee members, as required by law. In response, the agency instituted new guidelines in January 2002, requiring more detailed financial conflict-of-interest disclosure publicly at the beginning of advisory committee meetings held to consider specific drugs.