Daniel Carpenter: belief

Transcript context

…Two things. Number one, I think that the UK is again sui generis. In part, they trust their own company, and they trust their National Health Service. They’ve got a very good public system, which, if we recreate it in the United States would really dramatically transform that. Look, the correlation between vaccine hesitancy factors as expressed in public opinion and first-dose vaccination of eligible population in the United States is 0.6. That’s an extremely high correlation. Rather than just use a story, let’s actually look at data, and the data suggest, in fact, that public opinion on vaccine confidence is a very, very strong predictor of actual vaccinations in the United States. The other example I would say is part of my theory of the FDA. Let’s divorce it, to some degree, from vaccination more generally. Let’s look more broadly at what happens. It’s not just that people said last summer, “Oh gosh, we don’t trust Trump.” It’s that we don’t trust certain kinds of procedural irregularities that are going on at the FDA, which, of course, are very deeply Trump-related, but I’ll give you another example. It’s a completely different example in a different world, but I think it’s important. It’s a tragic story. There’s this deadly disease, Duchenne multiple dystrophy, for which was developed a really important drug called eteplirsen or Exondys. I say it’s an important drug. It’s an important drug therapy. It’s actually still not known whether it works in many respects. The FDA approval procedure was, shall we say, different and marked by much more controversy than usual. The advisory committee voted against it. The division director voted against it. Janet Woodcock, senior director, voted for it. I believe it was then Commissioner Robert Califf who approved it over and above the other objections, and that’s fine. He had his right to do that, but it was clear from everybody watching that this was not the usual approval process. You say, “What’s the problem? Now we’ve got this drug for a deadly disease that’s on the market.” The problem is lots of insurers now won’t cover it, still won’t. The New York Times ran a story about this, and they got one exec to say — and I’m paraphrasing. You can look up the story. I know that I just looked up a whole bunch of Blue Cross Blue Shield groups — still won’t cover Exondys. They basically said, “We don’t know whether this works.” This is not vaccine hesitancy, where you’ve got all the standard psychological . . . These are informed purchasers. So, part of what happens when you have procedural irregularity or corners cut or bad evidence underlying approval decisions is, you get, in some cases, what might be rational hesitancy on the part of treatments. I think we can say right now, with the benefit of hindsight, “Hey, look, we’ve got these great mRNA vaccines. We’ve got some other vaccines out there.” Sure. ional hesitancy on the part of treatments. I think we can say right now, with the benefit of hindsight, “Hey, look, we’ve got these great mRNA vaccines. We’ve got some other vaccines out there.” Sure. If we had done things differently, that’s right, but of course, that’s not what I would regard as a proper, rational and Bayesian way to think about it. The question is, what decisions should we have made at the time, given the information we had? You might be saying, “Well, I want a value function that places heavy, heavy emphasis on the option value that things could just go right here.” I’m very much open to that, but what I want, also, is a world where the unknown, deeply unknown product studied or being potentially approved gets studied massively, thoroughly, and where the studies continue well after approval. That’s, by the way, something else that you miss with the Good Housekeeping model. You don’t have any incentive for continual study of things that are something like Prozac or a statin, taken for 5, 10, 15, 20, 30 years of a person’s life. You can often get better data when you do a human challenge trial. Do you favor those? Should the federal government have started those in, say, May?…

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