February 19, 2008

We got a free preview of plaintiffs' opening statement when "60 Minutes," following its victims-and-villains storyline, makes much of the fact Bayer didn't reveal the existence of an unfavorable Trasylol study to the FDA at a September 21 advisory committee meeting. Leave aside that "60 Minutes" fictionally envisions that the drug, which did only 250 million Euros of business in 2005, would have been a billion-dollar-a-year drug, though it had been on the market for ten years. Leave aside that heart surgeries that used to take three hours are now taking ten hours because Trasylol sales are suspended (though the FDA, as of January, does continue to permit Trasylol use in special circumstances). But 60 Minutes reports that Dr. Alexander Walker "bl[e]w the whistle," when in fact, Bayer self-reported the existence of the i3 study on September 27—only six days late. Because the i3 study did not meet FDA methodological criteria, the FDA did not act when it received the study. (Compare: when the preliminary results for BART, a study with the appropriate prospective methodology, were released, the FDA suspended Trasylol sales within ten days.)