Will The FDA Kill Biotech?

By Karl Thiel -- Renowned FDA whistleblower David Graham made headlines again this week by getting permission to publish a paper he authored on the impact of Merck’s (NYSE: MRK) erstwhile pain pill Vioxx. He concludes that it may have caused somewhere between 88,000 and 139,000 heart attacks since 1999, 30% to 40% of them fatal. Expected to be published in the prestigious British medical journal The Lancet, Graham’s research is sure to capture a lot of attention among doctors, patients, and needless to say, lawyers. But perhaps more significant than the paper’s findings is the story of the publication itself. Graham has maintained the FDA hindered him from publishing this research earlier and that the agency even urged The Lancet to suppress publication.That claim, revealed in congressional testimony last year, was a baseball thrown firmly into a congressional hornet’s nest already buzzing over the withdrawal of the drug itself. Now legislative proposals for FDA reform are coming out and it’s time for investors to decide if some hopped-up legislators are a danger to their investments. More...

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