Larry Husten, at CardioBrief, made several important points overnight, about the delayed IMPROVE-IT trial -- and did so in a very coherent fashion. I had a few musings on this, last week -- but this one lays it all out very carefully. Do go read it all, but here is a taste:
. . . .It’s hard to argue with [Dr. Califf's] point. If ezetimibe wins it wins, we will all benefit, and there will be a useful new drug added to the armamentarium. But let’s be clear: the positive scenario is what Merck was trying to get everyone to envision all along, despite the lack of evidence, and it’s why, until ENHANCE at least, Vytorin and Zetia were spectacularly successful drugs. (They’re still successful, of course, but not at the same level, and the spectacle is of an entirely different nature.) But Califf, et al., don’t discuss the alternative possibility: what if the trial does not show a reduction in cardiovascular events? It’s curious that they can only imagine the positive scenario. What are the implications of a negative result? What lessons will be learned if that scenario comes to pass?
Indeed. Do go read the much longer article.
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