From Fen Phen, to Rezulin, to Vioxx, to Avandia, the story follows a predictable pattern. The Food and Drug Administration, which currently sees itself as an arm of the pharmaceutical industry rather than a consumer protection agency, approves a drug with little more than reliance upon data provided by the drug manufacturer and advice from FDA advisory panels which are increasingly comprised of paid consultants to the very drug manufacturer seeking approval of its drug. Following drug approval, mega-marketing campaigns convince consumers and prescribing physicians to switch from tried and true drugs to the new “blockbuster” drug. Often, the new drug is more expensive, less effective, and more dangerous. The next predictable event is the publication in the medical literature of proof that the manufacturer of the blockbuster drug knew either from pre-marketing clinical studies or post-marketing surveillance that the drug posed serious, unnecessary health risks. Does the manufacturer immediately upon discovery of this information warn the public, warn the prescribing physicians, and
disclose all to the FDA? The answer is a predictable, “NO.’ Instead, the predictable course of action is that the manufacturer attacks the messenger. The Avandia debacle is unfolding in the same all too predictable pattern. On Saturday, the New York Times reported that John B. Buse, M.D., the incoming President of the American Diabetes Association, and early whistle blower concerning Avandia’s health risks, was the target of an effort by Avandia’s manufacturer, GlaxoSmithKline, to silence his criticism of the drug. I reported last week that Dr. Buse raised a red flag about the danger of Avandia as early as 2000. Congressional investigators are looking into the allegation that Glaxo tried to intimidate Dr. Buse and others who warned about the cardiovascular risks of Avandia. Dr. Buse is scheduled to testify before a Congressional committee on Wednesday. One of his colleagues confirmed that Glaxo tried to pressure Dr. Buse by contacting his employer, the University of North Carolina Medical School. Glaxo’s foundation donates millions of dollars to UNC, and Glaxo tried to use its financial leverage to silence Dr. Buse. The time has come to end the incestuous relationship among the FDA, the drug manufacturers, the medical research institutions, and the doctors who serve on the drug advisory panels. Dr. Buse deserves credit for having the courage to report the truth.