December 14, 2007

Back to the question raised by Eye on FDA about a stealth change in policy at FDA regarding standards for drug safety.

In April, the New York Sun ran an op-ed by John Calfee, a senior fellow at AEI, that raised the issue in regards to the FDA's decision to deny market approval for Arcoxia, a painkilling drug in the Cox-2 class.

Having been approved by nearly all other advanced nations, Arcoxia approval here should have been a slam dunk. But if the FDA committee voted to approve Arcoxia, it would invite criticism for tolerating a drug known to cause heart attacks. So the FDA offered a way out: simply raise the standard so that only superior drugs are approved. That is essentially what the committee did by a vote of 20 to 1 when it recommended against Arcoxia approval because comparable drugs were already on the market.

What neither the FDA nor its committee seems to have considered is what its superiority standard will do to patients and health care costs. Clear superiority for the average patient can be demonstrated only through mammoth clinical trials at great expense. But some drugs are only superior for subgroups of patients. The only way to demonstrate that kind of superiority is to run even larger trials; Arcoxia's huge 34,000-patient trial was insufficient. Under the old approval standard, patients can find out which works best; under the new standard, they will have to wait years just to get a choice.

Read the whole thing. Raising the standard for new drugs to be "safer" than existing drugs sounds like a good idea in the abstract, but it runs headlong into the problem that different drugs have different effects subgroups of patients. It also ignores the fact, at Calfee points out in this article, that newer drugs are apt to look less safe than older drugs simply because older medicines have not been studied as intensively.

The solution is not to raise the bar for drug approval, but to collect more information about drugs once they are on the market, to help doctors and patients use both old and new medicines more effectively.

Posted by Paul Howard at December 14, 2007 01:58 PM

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