I'm curious: how much worse it is for someone to choose to take a medicine that harms them (assuming they were given the available context), vs. for someone to be harmed by not having access to medicine because it isn't approved?
Personally, I see the latter harm as greater.
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Sure, but I see these as a primarily (exclusively?) moral questions, rather than regulatory ones. My moral intuition is pretty clear on this, in the context of COVID vaccines.
No worries if you'd rather not get into your own moral philosophy; I realize that's pretty invasive.
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Gotcha. I think that I agree with that in many borderline cases, and that the thing about the COVID vaccines is that the cost-benefit analysis is so tilted that it doesn't feel like the small tail cases matter much.
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My perception is that the FDA is extremely conservative because they view their approval as reflecting a very high standard of evidence. Which is fine in abstract, but interacts badly with the very blunt regulatory hand that they use (literally banning things completely).
A less conservative approach would almost certainly release more harmful/ineffective drugs! I just think that would be worth it. But, I think it's important that those of us who advocate for this actually bite that bullet.