David J. Graham, M.D., M.P.H., is a drug safety whistleblower working at the Food and Drug Administration (FDA). On November 18, 2004, Dr. Graham testified before the U.S. Senate Committee on Finance about Merck’s withdrawal of the popular anti-inflammatory drug Vioxx. He testified that FDA policies could not protect the public from drugs with unacceptable risks. “I would argue that the FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless.” His words ring prophetic today as the FDA’s Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee convenes at the Hilton Hotel in Gaithersburg, Maryland. Dr. Graham is scheduled to speak at 3:00 pm today on “Risk of Acute Myocardial Infarction, Stroke, Heart Failure, and Death in Elderly Medicare Patients Treated with Rosiglitazone [Avandia] or Pioglitazone.” Dr. Graham and one of his FDA colleagues, Kate Gelperin, have previously called for the popular diabetes drug Avandia to be pulled from the market. Their study of the drug found possible evidence of an increased incidence of mortality.

Dr. Graham’s research has helped protect the public from other unsafe drugs, including Omniflox an antibiotic, Rezulin, a diabetes treatment, Fen-Phen and Redux, weight-loss drugs, and phenylpropanolamine, an over-the-counter decongestant, Lotronex, Baycol, Seldane, and Propulsid.

A story in today’s New York Times discloses that Avandia’s maker, GlaxoSmithKline, knew about Avandia’s heart attack dangers since 1999. Coincidentally, the Los Angeles Times is reporting today that GlaxoSmithKline ill pay $460 million to settle claims by Avandia victims. The LA Times reports that this is good news as the market had anticipated that the company would suffer $6 billion in losses from Avandia. Troy Media is reporting today VIOXX caused 140,000 heart attacks that killed 60,000 people. It adds:

[F]ormer FDA medical reviewer Dr. David B. Ross stated, “industry has become FDA’s client. People at FDA know that they have to be careful about upsetting industry” and that “even if a product doesn’t work, . . . there is pressure on managers that gets transmitted down to reviewers to find some way of approving it.” Former FDA medical reviewer Dr. Robert L. Misbin, now deceased, likewise observed: “One of my superiors said something . . . I have never forgotten, that we have to maintain good relations with the drug companies because they are our customers.” In each case, these career government scientists spoke out, aware that doing so invited agency retaliation; FDA has a long, sordid history of retaliating against whistle-blowers.

I must wonder if Avandia really is another VIOXX. I would hope that another 60,000 deaths would be enough to get the U.S. Senate to pass meaningful protections for federal employee whistleblowers.

By the way, I have now learned that Dr. Misbin is not deceased. Troy Media erred both in reporting that his is “former FDA” and “now deceased.”  I received an email from him that you can read in the comments to this blog entry.

  • Robert I Misbin

    Contrary to your blog, I am still very much alive, and still working at FDA.

    Regarding Avandia, I wrote to my superiors on May 10, 1999 threatening to withdraw my recommendation for approval unless the Avandia label gave information about adverse effects on lipid levels. This memo stated:

    “Although treatment of hyperglycemia is important, we must not lose sight of the fact that heart disease is still the biggest killer of patients with type 2 diabetes and the risk of heart disease may be increased by treatment with RSG (rosiglitazone). Individual physicians may conclude that other benefits of RSG offset this potential risk in certain patients.”

  • David Graham is a true American hero.