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Approving drugs based on wishful thinking isn't how the process is supposed to work, but that is what happened here. It is still pretty unclear whether the amyl

Approving drugs based on wishful thinking isn't how the process is supposed to work, but that is what happened here. It is still pretty unclear whether the amyloid hypothesis is true and whether reducing amyloid would actually treat the cause of Alzheimers. The trials for this drug failed, they were stopped because it didn't work. And then they picked some data out of that and decided it reduced amyloids, so we just approve it based on that even without a clear signals that patients actually benefit.

pfisherman 5y ago
> Approving drugs based on wishful thinking isn't how the process is supposed to work… This is not entirely correct. There is relatively recent FDA guidance addressing the balance of pre market and post market data collection.[1] I am aware the title of the guidance says devices, but note that the center for biologics evaluation and research (CBER) is on the guidance. That being said, my opinion is that this decision by FDA is an abomination — the second extremely questionable approval on Woodcock’s watch — and never should have happened. [1] https://www.fda.gov/regulatory-information/search-fda-guidance-documents/balancing-premarket-and-postmarket-data-collection-devices-subject-premarket-approval https://www.fda.gov/regulatory-information/search-fda-guidan...