More on the FDA and Science

Hello, Ryan here again, just helping Mr. Kilgore out with a post or two today.

Anyway, my post from Friday about the FDA got a lot of responses. (To summarize briefly, Rand Paul got a proposal passed saying the FDA should accept science performed outside the US, while Alex Tabarrok went further, proposing to automatically accept any drug or treatment accepted in the EU, Canada, Japan, Australia, or New Zealand. I tentatively agreed with Alex’s proposal.)

Commenters on the post brought up thalidomide, which is surely worth considering. In case you don’t know, that was a drug used for a short time in Britain, Australia, and elsewhere to treat morning sickness. Turns out, it causes horrible birth defects, and the US mostly dodged a bullet when the FDA administrator of the day refused to approve it, saying more studies were needed.

But these days, the problem with the FDA isn’t something like thalidomide, which simply wasn’t studied enough before it was introduced–in fact, that episode led directly to strengthened regulations for new drugs both in the US and elsewhere. Now the big problem is pharma lobby capture of the approval process. The rule to demonstrate efficacy of a new drug today (to simplify a bit) is two rigorous positive-result studies. However, drug companies can sponsor as many studies as they like, and don’t have to reveal any they don’t like (i.e., negative results), as they’re considered proprietary and therefore confidential. That distorting influence is what leads to things like Vioxx.

So on further thought, I think the commenters that disagreed with Tabarrok are right. That kind of automatic process would probably lead to the pharma lobby concentrating their power on the country with the weakest regulators to get mechanical, rubber-stamp approval. (Which, sadly, could very well be the US.) However, I still think Paul’s proposal is good. More studies from credible sources can seldom hurt, especially in the current environment. I would combine it with mandatory open-access rules for publicly-funded studies, and more journals dedicated to publishing negative results.

If we wanted to get really ambitious, we could propose scrapping the drug patent system, and replacing it with a prize system. Am I missing any other good ideas?

Ryan Cooper

Ryan Cooper is national correspondent for the Week, and a former web editor for the Washington Monthly.