December 19, 2004

"Safe" drugs

In a NYT article discussing the controversy over the drug industry's heavy marketing of COX-2 inhibitors like Vioxx and Celebrex, we read the following:

But the rapid rise and now shaky future of [COX-2 inhibitors], some researchers say, is emblematic of the way drug companies' efforts to spur the use of costly new medicines can distort the medical realities of safety and effectiveness.
Is there such a thing as a "medical reality of safety"?

We often talk as if there is such a thing as a "safe" drug and an "unsafe" drug, and as if the FDA's job is to distinguish one from the other. But safety is like beauty--it's in the eye of the beholder. When I go on solo backpacking trips, it doesn't seem to me like I'm doing anything that's particularly dangerous. I suspect that my mom often disagrees with me. Who's right? Answering this question is like trying to figure out once and for all if Georgia O'Keefe's paintings are pretty or not.

There is really no such thing as an objectively "safe" medical treatment. The question we should be asking of the FDA is whether it is protecting the public in the way that we think is most appropriate. This means that critics and supporters of the FDA will have to make messy political arguments, because we will often disagree about what "appropriate" means. The crucial questions are who gets to decide whether a drug is safe, and what limitations we ought to place on efforts to influence that decision.

It's tempting to think that there's some sort of objective standard of "safety" to which we can appeal to short-circuit the political disagreement, but alas, there is no such standard. Anyone who tells you different is trying to sell you something.
EDIT: Adam provides an example of what can go wrong when docs make the safety decision in a case involving anti-AIDS drugs in Africa.

Posted by Carey at December 19, 2004 09:11 PM