Daniel Carpenter: belief

Transcript context

…Take off-label prescriptions for drugs, which are a highly significant phenomenon, as you know. That’s not subject to FDA approval. Should we change that? In essence, a significant percentage of total drug usage is not regulated directly by the FDA for the purposes it’s being used for. Right. Excellent. Good question. I’ve thought about this a little bit. I think there’s a lot of room for flexibility in the current system. One of the things that I try to say, I’m happy to criticize the FDA on any number of things, and I’m sure we’ll get a chance in what time we have today, but there’s actually been a fair degree of flexibility. Maybe it’s come slower than you might hope for in cancer, but cancer is sui generis in many respects. Adherence rates are very high because a lot of the drugs are given just directly in the clinic. It’s a community of researchers that is essentially highly closed. There are some doctors here and there who do things, but it’s governed immensely by ASCO. There’s a kind of a community of practice there. What the FDA does in a lot of these cases is allows for a molecule to be approved, say, cisplatin would be an example of the first platinum-based chemotherapy, and then basically knows — I think the FDA knows that when a lot of these molecules are out there, there’s going to be off-label prescribing. That’s not to say, however, that off-label prescribing is not regulated. Whether something is on the label or not is still a significant decision. I’ve written about the case of bevacizumab for breast cancer, and that was a pretty significant decision by the FDA, one that a number of industrial interests fought against pretty hard, in part because they knew that money was on the line. If we think about testing for COVID-19, starting maybe with Paul Romer and Glen Weyl, who has been on this podcast, Michael Mina, a variety of commentators, Alex Tabarrok, now Ezra Klein — all have believed, and in some cases shown using measurements, mathematics, statistics, that if much earlier COVID-19 testing had been available, although imperfect, that the United States would have been much better off. The FDA only now, this week in the end of March, is allowing such testing. Doesn’t that verify the old-style Sam Peltzman argument that the FDA is too risk averse, too slow? And when the FDA finally did let some of that testing through, you had to do it with a prescription, which seems to make no sense under any worldview. Was Sam Peltzman right about the FDA?…

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