FDA tried to discredit whistleblower over drug safety claims


November 25, 2004
Health, Uncategorized

The Food and Drug Administration tried to discredit one of its own experts after he told a US Senate hearing that the FDA had failed to protect the public over rofecoxib (Vioxx), according to two articles published online by the BMJ today. Dr David Graham, Associate Director in the FDA’s Office of Drug Safety, said that the FDA was ”incapable of protecting America against another Vioxx.” He also indicated that five other drugs currently on the market may be endangering patients.

From British Medical Journal:

FDA tried to discredit whistleblower over drug safety claims

The Food and Drug Administration (FDA) tried to discredit one of its own experts after he told a US Senate hearing that the FDA had failed to protect the public over rofecoxib (Vioxx), according to two articles published online by the BMJ today.

Dr David Graham, Associate Director in the FDA’s Office of Drug Safety, said that the FDA was ”incapable of protecting America against another Vioxx.” He also indicated that five other drugs currently on the market may be endangering patients.

Dr Graham led a study that looked at the cardiovascular risks in patients taking rofecoxib (Vioxx). This was to have been published in the Lancet but was pulled at the last minute after Dr Graham had a warning from his supervisor about publication

The FDA issued a statement after the hearing last week, claiming that Dr Graham had failed to adhere to agency protocol when he submitted his data to the Lancet.

Fearing for his job, Dr Graham sought the help of the Government Accountability Project, a public interest group that protects whistleblowers in order to promote governmental and corporate accountability.

But the group received another request from an anonymous whistleblower at the FDA who was being ”bullied” by Dr Graham. The caller also said that Dr Graham’s study could reflect scientific misconduct. After some investigation, the ”anonymous” call was found to come from FDA management, attempting to discredit Dr Graham.

Mr Tom Devine, legal director of the Government Accountability Project said the FDA’s attacks on Dr Graham’s credibility were implausible.

Something is rotten at the heart of the FDA, adds Dr Kamran Abbasi, acting BMJ Editor. As one of the world’s leading drug regulators, the FDA needs to show that its primary role is to protect the public and not to protect industry.

Four of the five companies whose drugs Dr Graham said might be endangering patients, have defended their drugs’ safety when used as indicated. One company, Roche, had no comment to make on the allegations.



FDA tried to discredit whistleblower over drug safety claims

4 Responses to FDA tried to discredit whistleblower over drug safety claims

  1. Fred Bortz January 10, 2010 at 12:58 pm #

    The first chapter of Denialism, a new book that I reviewed recently, discusses the mistakes that the manufacturer made in the handling of data showing serious side effects for Vioxx in people with heart problems. The author’s view is that it should still be on the market with strong, clear warning labels.

    I gave the book a negative review for its dismissive tone toward people the author views as denialists. Unfortunately, I think that feeds the denialists, who blame the messenger when they can’t deny the science. His tone will turn off open-minded skeptics whom he might otherwise persuade.

    For instance, I think whether to keep Vioxx on the market is a policy question, not a scientific one. Regulators have to judge whether it is sufficiently better for some patients than Celebrex and other like drugs with a lesser (but still not zero) cardiac risk. If the FDA scientists recommend and FDA commissioners decide that it be kept off the market rather than merely having a warning label, does that make them Vioxx denialists? Hardly! They are people who looked at the evidence and came to a conclusion about the appropriate policy based on what they saw.

    Your doctor is probably well aware of the studies behind the FDA decision. He is probably also aware that the drug manufacturer did not apply for it to be returned to the market for use in certain particular circumstances. Thus it would probably constitute malpractice for the doctor to prescribe it (if it is available from some sources, perhaps overseas) instead of near-equivalent drugs like Celebrex.

    Though I didn’t like Denialism overall, I would recommend it for a concise summary of the issues surrounding the removal of Vioxx from the market.

    Fred Bortz

  2. Anonymous January 10, 2010 at 11:52 am #

    My Doctor quotes you, db, when I ask questions about Vioxx and Celebrex. He says there are many like you who are demanding Vioxx be put back on the market, and would be willing to sign a waver for the risks that Vioxx pose.

    I don’t believe it. The phenomenon of “trolls” at online forums is a reality now, where people are paid to post certain opinions like yours. The Global Warming denialists are doing that for sure.

    What I need is to find at least ONE real person who will tell me face to face that they love their Vioxx [to death?] and that Celebrex is not an adequate substitute. My Doctor does not happen to have any such patient in his practise… but even that does not raise his suspicions.

  3. jenerotok December 14, 2008 at 5:08 am #

    Transparency is absolutely essential when dealing with drug studies. Deceptions of study authorship undermine American public health and consumer confidence of the FDA’s ability to protect patients. Of course, that confidence is pretty low nowadays anyway.
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  4. Anonymous November 26, 2004 at 8:30 am #

    I worked for the Feds for 20 yrs and I bet I know just the type of person Dr Graham is: whiney, under-appreciated and totally self-interested. It never occurred to Dr Graham that I, and many patients like me, took Vioxx because no other drug worked. I have a stomach made of cast iron and could digest raw rhino but I took Vioxx because it made my life normal. Normal means I run 4 mi a day, lift weights, dance, play with kids, sit, stand, anything I please. For the week I went without Vioxx (before I got some Bextra) I literally crawled with pain from muscle spasms, and the “stabbing” of neuropathy. Celebrex does not work for me. I wish it would, it is less expensive.

    Please someone save me from “saviors” like Graham. Having worked with the Feds I believe Dr Graham’s claims are implausible. The Feds are not that co-ordinated and all workers in federal agencies are suspicious of corporations and companies. If Graham had something special to say, it would have been said by other guys already looking for their next promotion. Graham just didn’t want to wait his turn in the agency promotion chain.

    Too bad they pulled Vioxx from the market. Any damage done to my heart by Vioxx is well worth the damage it saved me from due to the kind of life I would have led without it.

    Dr Graham, get out of my life.

    db

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