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    Tuesday, November 23, 2004

    Coming Soon to a Bookstore Near You: Druglords, an FDA tell-all:

    Dr. David J. Graham, the drug safety reviewer who denounced his employer, the Food and Drug Administration, before a Congressional panel last week, said yesterday that he feared being fired and had sought legal help from a group that protects whistle-blowers.

    'My concern is retaliation from these people,' Dr. Graham said in a telephone interview.

    His lawyer, Thomas Devine, legal director of a public-interest group, the Government Accountability Project, said that he had received anonymous telephone calls trying to discredit Dr. Graham and that he believed the calls were from people in 'F.D.A. management.'

    Now, can he get Russell Crowe to play him in the movie?

    The FDA's response to the controversy caused by Graham's accusations of persecution:

    In 2001, a project officer [presumably Graham] in ODS[Office of Drug Safety] expressed interest in a scientific collaboration between the Office of Drug Safety and Kaiser Permanente of Northern California on the cardiovascular safety of cox-2 drugs. FDA provided partial funding for this pilot project in August 2001 and again a year later, and our project officer served as the project manager.

    Last February, our project officer submitted an abstract to the International Society for Pharmacoepidemiology (ISPE) for presentation at the group's August meeting in Bordeaux, France. It described the final study population of nearly 1.4 million patients and the events being studied, but it included no results.

    When this draft was shared with the project officer's supervisors within ODS to obtain review and clearance on August 11th, ODS supervisors immediately recognized the importance of the project officer's work and the need to complete a study report for FDA review and publication in a peer-reviewed scientific journal.

    Some FDA scientists questioned some of the conclusions in the abstract and, as a result, the project officer voluntarily chose to revise his conclusions, and he did so, in his own words, "without compromising my deeply held convictions."

    This poster was presented in Bordeaux in August and discussed publicly at that time. When he returned, his supervisors in ODS asked him to submit a draft report on his findings within two weeks. It was not submitted to the Center for review until September 30th, after Vioxx was voluntarily withdrawn from the market. Senior drug experts in FDA did not have this report or the underlying data prior to that time.

    Second, more recently, the project officer notified his supervisors that he had submitted his findings in a paper to The Lancet. He did this without going through the long-established peer review and clearance process established for scientific papers submitted by FDA scientists. When FDA scientists learned that this paper had been accepted for publication in The Lancet, despite not having gone through the normal peer review process, the director of FDA's Center for Drug Evaluation and Research contacted the journal's editor, out of respect for the scientific peer review process.

    Let's see. The whistle blower doesn't hand in his assignments on time and he ignores inhouse rules about peer review so he can rush his paper to The Lancet, which is notoriously lax when it comes to critically reviewing papers - especially papers that are topical and fit in with the news story of the day. (It was The Lancet, remember, which published the paper wrongly linking the MMR vaccine to autism, and it was The Lancet which rushed to publish a deeply flawed statistical analysis of Iraqi civilian deaths just days before our Presidential election.) Sounds like he's more interested in burnishing his own image. Our drug approval process certainly has its problems, but there's something fishy about this guy.

    posted by Sydney on 11/23/2004 11:45:00 PM 0 comments


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