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There is a history of these agencies later withdrawing approvals and FDA conservatism protecting US healthcare consumers. The same pattern applies with these ot

There is a history of these agencies later withdrawing approvals and FDA conservatism protecting US healthcare consumers. The same pattern applies with these other agencies not basing decisions on FDA approval. Overall, the combination of approval authorities and global surveillance delivers the best results by ensuring the broadest coverage and continued research.

BurningFrog 2y ago
The rarely understood tradeoff in this arena is that no matter what you do, your decisions kill people! Everyone understands the case when (A) you approve something that later turns out to kill people. The other case (B), when you don't approve something that would have saved lives is much less understood, but those people are just as dead as those from case A. One famous case B is when the FDA only approved beta blockers 17 years after other major countries. This cost ~10k US lives per year, or ~170k lives total. Because A errors produces headlines and scandals, while B errors are just the normal deaths we are used to, the FDA is heavily incentivized to minimize A errors, regardless of the B error rate.
- bobthepanda 2y ago
  The incident around thalidomide is basically FDA mythos at this point.
- dwattttt 2y ago
  We all love a good trolley problem
  - the8472 2y ago
    https://web.archive.org/web/20210125231725/https://blog.jaibot.com/the-copenhagen-interpretation-of-ethics/ https://web.archive.org/web/20210125231725/https://blog.jaib...
- selimthegrim 2y ago
  Not just lives also DALYs from glaucoma.
- MostlyStable 2y ago
  An important thing to remember when thinking about this thing: the downside of approving a drug that was dangerous is bounded: it kills people or causes some unexpected side effect and then it gets pulled. Meanwhile, the downside of failing to approve something that could have saved/improved lives is at least potentially unbounded: if it never gets approved that's the entire futures worth of humanity who is unable to take advantage of it (although admittedly I'd like to imagine that _eventually_ tech will improve to the point that we either figure out we should approve the drug and/or invent something else that obviates the need). The point is that case B is both harder to notice and at least potentially _much_ worse than case A. And it's the case that the FDA currently errs towards.
- ajmurmann 2y ago
  And I hope we've all seen Dallas Buyers Club which showed the real, historical problem of drug approval being slow-rolled because it was killing a controversial minority

BurningFrog 2y ago

The rarely understood tradeoff in this arena is that no matter what you do, your decisions kill people! Everyone understands the case when (A) you approve something that later turns out to kill people. The other case (B), when you don't approve something that would have saved lives is much less understood, but those people are just as dead as those from case A. One famous case B is when the FDA only approved beta blockers 17 years after other major countries. This cost ~10k US lives per year, or ~170k lives total. Because A errors produces headlines and scandals, while B errors are just the normal deaths we are used to, the FDA is heavily incentivized to minimize A errors, regardless of the B error rate.

bobthepanda 2y ago
The incident around thalidomide is basically FDA mythos at this point.
dwattttt 2y ago
We all love a good trolley problem
- the8472 2y ago
  https://web.archive.org/web/20210125231725/https://blog.jaibot.com/the-copenhagen-interpretation-of-ethics/ https://web.archive.org/web/20210125231725/https://blog.jaib...
selimthegrim 2y ago
Not just lives also DALYs from glaucoma.
MostlyStable 2y ago
An important thing to remember when thinking about this thing: the downside of approving a drug that was dangerous is bounded: it kills people or causes some unexpected side effect and then it gets pulled. Meanwhile, the downside of failing to approve something that could have saved/improved lives is at least potentially unbounded: if it never gets approved that's the entire futures worth of humanity who is unable to take advantage of it (although admittedly I'd like to imagine that _eventually_ tech will improve to the point that we either figure out we should approve the drug and/or invent something else that obviates the need). The point is that case B is both harder to notice and at least potentially _much_ worse than case A. And it's the case that the FDA currently errs towards.
ajmurmann 2y ago
And I hope we've all seen Dallas Buyers Club which showed the real, historical problem of drug approval being slow-rolled because it was killing a controversial minority