Remember this guy DANK . He helped put Relenza back ten years by his recommendation to FDA commitee in 1995. Good to see he is being hounded for his stuff ups.
Article out yesterday 24/04/06
Government Accountability Office Report Highly Critical of FDA Is Anything But News to Most Observers
''The FDA abides by a simple yet essential question in its approval process: Do the benefits of a drug outweigh its risks? This idea of risk vs. benefit was first adopted about 30 years ago but it is now the basis for new drug approval.
The current law states that all new drugs need proof that they are effective, as well as safe, before they can be approved for marketing. The problem with the current approval process, however, is that even when the answer to this question turns out to be “no,” many dangerous drugs have either been approved or permitted to remain on the market for considerable lengths of time.
For example, Michael Elashoff, an FDA reviewer and biostatistician, was asked to review the flu drug Relenza back in 1995. Elashoff recommended against approval due to the lack of efficacy of the drug and the agency advisory committee agreed and voted 13 to 4 against approving Relenza.
Yet Relenza was ultimately approved by the FDA and Elashoff was told that he would no longer make presentations to the advisory committee. Rezulin and Vioxx were both approved and marketed for years despite the fact that strong evidence of their potentially dangerous side effects was well known while the drugs were still being tested.''
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