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December 20, 2005
Does Celebrex Have A Future At All?
I have a correspondent who's written me a few times about the Vioxx/Celebrex/NEJM situation, and I thought I'd pass along some of his thoughts. He's not buying my idea that the New England Journal is worried about being sued, for one thing. As he points out, the various liability battles that have taken place over the last twenty years also have had potential for that sort of thing, and no one's done it yet.
And as for Pfizer's big Celebrex trial, he regards it as four years worth of lawsuit insurance, and cheap at the price. That's a reasonable idea, unfortunately, but I wonder if that would slow down a sufficiently motivated member of the plaintiff's bar. After all, they could make the argument that the company clearly had no idea (italics theirs!) if their product posed a cardiovascular risk or not - that's why they had to run a trial, naturally - and meanwhile had recklessly exposed consumers to the dangers of this insufficiently tested drug. . .man, once you start on those italics, it's hard to stop.
However, my correspondent isn't even sure that this is an ethical trial at all. (That Forbes article I linked to the other day had quotes from others raising such concerns). If you believe that COX-2 inhibitors have mechanism-based cardiac risks (a hypothesis publicized best by Garrett Fitzgerald at Penn), then Celebrex isn't going to be able to escape. There's room to argue that the COX-2 drugs don't have as good a gastrointestinal safety profile as had been hoped, either, which would take away another reason for their existence (and another ethical rationale for the new trial). Celebrex had better be good at relieving pain. . .
I should point out that if these effects are real, neither of them are things that would have been obvious earlier in the development of the COX-2 drugs. The rationales for their development were actually quite compelling at the time (just ask the University of Rochester - anyone heard from them recently?) But that's drug development for you. Every single new drug has risks, many of which aren't even known until millions of people take them. Would that it were different, but it isn't.
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