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Friday, August 26, 2005

Vioxx Verdict: AEI Cries "Junk Science"


Predictably, conservative "tort reformers" are now proclaiming that the Vioxx verdict -- finding the makers of the popular painkiller liable for the death of a patient -- is nothing but "junk science." It's testimony to the power of a conventional narrative that anyone can make this claim with a straight face.

As I blogged a couple days ago, there's pretty overwhelming evidence -- including two large, randomized trials (the VIGOR and APPROVE studies) -- that Vioxx causes heart attacks. Even a layperson can easily verify the medical consensus by reading editorials in the most prestigious medical journals, which express no doubt.

But the American Enterprise Institute's John Calfee claims to know better than the medical journal editors, writing, "junk science now threatens to reign supreme in drug litigation."
The lawyers had to surmount the views of FDA and Canadian expert panels that Vioxx was safe enough to return to the market; evidence that, to the extent that Vioxx was dangerous, it wasn't necessarily any more dangerous than other drugs; and the inconvenient fact that the deceased in the case had died of heart arrhythmia, a cardiac problem not associated with Vioxx.
But none of Calfee's claims are true. Yes, the FDA expert panel did vote 17-15 to return Vioxx to the market, but

"Many of the panel members who were among the narrow majorities approving continued marketing of Bextra and Vioxx did so only with the stipulation that severe restrictions be imposed on their uses," according to one panel member, who added that "he expected that the uses of the drugs would be confined to very limited patient populations."
The transcript of the meeting is online, so it can be easily verified that this is an accurate description of the discussion. Vioxx does have some advantages over other drugs, but the experts say its dangers mean that it should be used at low doses, for limited times, on patients with a low risk of heart disease. In other words, it should be a niche drug, not a multi-billion dollar blockbuster drug.

Yes, the FDA, possibly being overcautious, suggested that alternative drugs like Advil and Aleve might be just as dangerous as Vioxx, but this is just an educated guess, not something based on strong evidence. As Calfee himself points out, "Advil and older prescription and over-the-counter arthritis treatments...[have] not been subjected to long-term clinical trials like the one that seemed to reveal heart problems with Vioxx." If you look at the FDA panel transcript, you'll see that many panel members suggested that Vioxx should only be used after the over-the-counter remedies have failed.

Yes, the doctor who performed the autopsy did find the cause of death to be arrhythmia rather than a heart attack. But that same doctor ended up testifying for the plaintiff that it was a heart attack that triggered the arrhythmia! And University of Michigan pharmacology professor Benedict Lucchesi, "who has studied heart arrhythmias for more than four decades," testified that Vioxx "contributed significantly" to the death.

In other words, Calfee and the "tort reformers" think the views of a pharmacology professor at a top university, the FDA advisory panel, and the editors of major medical journals are "junk science." With the whole medical establishment in the wrong, it's hard to imagine where we can find any "sound science." At the American Tort Reform Association and the AEI?
 
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