16
162
362
Conversation
His writings always suggest that the FDA should lower its standards and move more quickly. That might occasionally be true, but with the rise of accelerated options (e.g., aducanumab, etiplirsen), there are many cases where the FDA's standards could hardly be lower.
2
1
Yeah,wonder what he thinks about that. Things like aducanumab (and also lots of cancer drugs) incentivise the biotech sector to grift past the FDA tired ineffective solutions rather than seeking more robust solutions. Perhaps if FDA approval could be decoupled from Medicare..
2
2
yeah, the flip side of cutting government regulation always has to be creating other institutions to do quality control and assessment. If we don't want "FDA approval" to mean "definitely works" then insurers or healthcare providers or whatever need to pick up the slack.
1
2
As a market-oriented kind of person, there are so many ways that could work, even just switching to a multi-tier FDA approval, with 'it's safe but idk about usefulness' and 'definitely works' and 'probably works'. Right now it's very black and white.
1
3
and then leave it up to doctors and insurers to decide the rest
2
3
This is close to my preferred version of the FDA. I want it to focus exclusively on rigorous *disclosure*, with legal teeth. Want to claim that a product contains a molecule? Better have the spectroscopy results to prove it.
Want to claim that it has some kind of effect? The FDA has predefined levels of evidence (from "correlational study" to "mechanistic explanation" to "double-blind pre-registered trial), and all of the data is held in a publicly-available escrow.
1
The goal is basically "LabDoor++, with legal teeth", and without every pharmacy (or worse, consumer) needing an analytical laboratory. But the goal is to make truth legible to consumers, not pick what level of evidence an individual needs, which requires cost-benefit analysis.