3 ms·

Although the FDA seem to be going against their brief - that is, only approving something that works and has acceptable risks - maybe that's not a bad thing. P

Although the FDA seem to be going against their brief - that is, only approving something that works and has acceptable risks - maybe that's not a bad thing. Playing devil's advocate, would it be preferable if the FDA just validated the manufacturer's claims were true rather than applied a value judgement on the drug? That way, even if it turns out this (and other similar) drug isn't useful for Alzheimer's in general, but if it turns out amyloid plaque clearing is found to have an actual use, then this drug could be immediately used? In a sense, embracing the "off label" use of medication that's already prevalent throughout medicine. I don't know whether this would make medicine better or not, but deciding on the risk vs benefit of a particular treatment is something that should be done between a patient and a doctor, provided they have access to all necessary information to make that decision and the claims made by the manufacturer are known to be valid.

jcranmer 5y ago
> Playing devil's advocate, would it be preferable if the FDA just validated the manufacturer's claims were true rather than applied a value judgement on the drug? The manufacturer's claims here are that the drug treats Alzheimer's. That's the key claim here that everyone cares about; the amyloid plaque-clearing part of it only matters insofar as it's hoped to be the key to Alzheimer's treatment. There's another factor to point out: strictly speaking, this drug is only approved conditional on a further clinical trial proving efficacy (which will take years because Alzheimer's trials take forever). Now take stock of how many headlines mention that fact, or even hint at the sharp disagreement (what an understatement) about the efficacy of the drug.
- cameronh90 5y ago
  "The manufacturer's claims here are that the drug treats Alzheimer's. " I know, it was just a bit of an aside. The reason they presumably claim this is because if they just claimed it cleared amyloid plaques, that wouldn't be approved by the FDA as it's not treating a condition?

jcranmer 5y ago

> Playing devil's advocate, would it be preferable if the FDA just validated the manufacturer's claims were true rather than applied a value judgement on the drug? The manufacturer's claims here are that the drug treats Alzheimer's. That's the key claim here that everyone cares about; the amyloid plaque-clearing part of it only matters insofar as it's hoped to be the key to Alzheimer's treatment. There's another factor to point out: strictly speaking, this drug is only approved conditional on a further clinical trial proving efficacy (which will take years because Alzheimer's trials take forever). Now take stock of how many headlines mention that fact, or even hint at the sharp disagreement (what an understatement) about the efficacy of the drug.

cameronh90 5y ago
"The manufacturer's claims here are that the drug treats Alzheimer's. " I know, it was just a bit of an aside. The reason they presumably claim this is because if they just claimed it cleared amyloid plaques, that wouldn't be approved by the FDA as it's not treating a condition?