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.
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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..
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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.
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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.
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and then leave it up to doctors and insurers to decide the rest
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right, it looks like currently accelerated approval is "no phase III required", which predictably means "less likely to be effective." so they shouldn't be auto-covered by Medicare exactly like drugs that *did* demonstrate effectiveness.
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A great start! And I think the 'auto-covered' clause is de-facto but not legally required (Stuart probably knows what it is?), if so it's ""just"" convincing the right people in some committee to stop taking FDA approval to mean=good for general use.
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Loosening FDA approval w/out payer reform is a bad idea, as U point out. But I think political economy of "rich people get new meds that Medicare and/or Medicaid don't cover" = unstable. Even UK has basically backed down w cost-effectiveness standards w cancer meds bc politics
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jamanetwork.com/journals/jama/
"January 2009, growing concern about access to newly licensed cancer medicines led NICE, with the agreement of the government, to introduce additional flexibility when appraising treatments that extend survival in patients with short life expectancy"
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This is fascinating and terrifying. Do you think there's any hope for allowing people to make their own cost-benefit decisions? Seems like a basic goal, but I think it necessarily means that wealthy people will have access to more things. In some sense, that's what wealth *is*.🤔
In some hypothetical world, maybe, but we live in a world with pervasive government involvement in healthcare and no party in any country is trying 2 change that, so the train has left the station on that Q already.
It's FDA or National payers or insurance making those decisions
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And IMO, it's politically more palatable to deny unproven drugs from EVERYBODY than to allow them for everybody and let payers and the market decide.
Imagine the headlines: "retired veterans denied lifesaving Alzheimer's drug (Aduhelm), rich people get tons of it"
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