Atul Gawande: prediction

Transcript context

…But the bigger risks seem pretty invisible. Some drug you’ve never heard of—it doesn’t even exist yet—you never get it and you die. That’s not very salient to people. It seems, insofar as the public judges the risk, maybe they’re getting it wrong. No, that’s right. The way to think about it, though, is that we have a certain speed with which we have accelerated passage through the FDA. We are doing surveillance afterwards, and then finding that the approval process leads to drugs being withdrawn from the market. That is a decision, that we have decided to accept acceleration, especially of drugs that’ll have to be tested on small numbers of people, and then we’ll monitor afterwards to be able to catch problems after they happen. And some of the disasters that have occurred, like Vioxx and others, where there were substantial cardiac affects happening to many, many thousands of people, there’s been a backlash against that. On the whole though, I think we have decided to trade . . . letting lots more drugs through and a little bit more quick process, but then try to have surveillance afterwards. Of course, one of the results is, we’re not investing very much in that surveillance. The worst of all worlds is, speed drugs through and then close our eyes to what harm is being done after the drug has hit the market. And that, of course, is where all of the incentives are from the drug-maker point of view. And then, when the public’s not paying attention, that’s where we start dialing back. And that’s one of my fears in the current regime is that, “OK, fine, we speed up the approval process, but then gut the ability of the FDA to hold the medical community to having surveillance of what happens and then pull the drugs on the market that are actually causing harm.” New surgical procedures, should the FDA have a greater ability to regulate them than it has right now?…

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