13 ms·

I personally like the idea of a "accredited ingestor". You get a certification indicating you understand enough about drug development and associated risks and

I personally like the idea of a "accredited ingestor". You get a certification indicating you understand enough about drug development and associated risks and then you are allowed to decide for yourself what you are willing to take. In general I am a big fan of FDA approval just becoming a stamp on a product like the Nintendo Seal of Approval and letting consumers and insurers decide what they make of it, but that would never fly

vips7L 2y ago
I write software for this industry, the thought of not involving the FDA genuinely scares me.
- ajot 2y ago
  I do admin work for a pharma-related company. I would never want to be in charge of verifying with my own body what treatment is safe and/or effective. Drug development and clinical trials are expensive for a reason. Not doing them in an orderly manner is more expensive.
- CamperBob2 2y ago
  Fortunately, the position would be voluntary. You might be a big fan of the work the FDA does to keep us safe in light of past industry abuses, but keeping good drugs off the market - whether by outright fiat or by making them too expensive to develop, test, and deploy -- also has a terrible human cost. It's not clear that the FDA has found the right balance between risk reduction and upside potential.
  - 0cf8612b2e1e 2y ago
    Drug development is a conservative industry. Even with researchers/companies/FDA all doing their best to develop good treatments, there are still many drug failures due to efficacy or safety. Being more lassiez faire is going to lead to direct harm of some patients. Is it a worthwhile tradeoff vs potentially addressing some unmet need is a tough calculus.
  - hobermallow 2y ago
    What criteria would you suggest to measure in an effort to make it clear that the FDA has >found the right balance between risk reduction and upside potential?
    - CamperBob2 2y ago
      I don't think there's a good answer to that question, unfortunately. What we're doing now seems to be working for most people most of the time, but it'd be absurd to think there's no further room for optimization. And it seems unlikely that the best approach is more restrictive regulation, given that extremely-useful drugs are going undeveloped for decades. So... that leaves more flexible regulation as a worthwhile approach going forward. I like the idea of making limited human trials easier to carry out and less costly in general.
    - bdzr 2y ago
      Not OP, but it's certainly not by leaving drugs unapproved in the US that have been in wide use in Canada, England, Japan, etc for years (and in some cases decades). The incentives are so misaligned for the FDA that the bias for inaction is enormous. I also find it a bit patronizing that a federal agency determines whether or not a drug they've deemed safe has enough upside potential for me. That's a value judgement I'd like to make for myself. Sorry if this sounds harsh, but the FDA's inability to approve drugs inside of a decade has personally impacted me quite a bit.
- BurningFrog 2y ago
  One far less scary version is to allow drugs approved by other reputable agencies (EU, Japan, UK, maybe) to be used in some limited capacity in the US.
  - ajot 2y ago
    From what I've heard from some friends working with regulatory agencies worldwide, this is currently the case or is about to happen. FDA-EMEA-(whatever the japanese regulatory agency's called) have agreements for treatments approved in one of the other two agencies to be easily approved.
  - zerkten 2y ago
    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.
      - 2y ago
paulmd 2y ago
that already exists, it’s called doing research chemicals. You can do survodutide or whatever other next-gen drug right now and “do your own research” on the supply chain and efficacy and safety. They’re everywhere and functionally the FDA can’t stop you. should that be officially legitimized in any way by the FDA? fuck no. As soon as you break down the barrier in any way, companies will spring up exploiting it and promising miracle cures etc. even if you want to do RCs the FDA keeping a minimal wall there benefits you.
- zoklet-enjoyer 2y ago
  Agreed. RCs were great when you had to know what you were doing to get them. It only became a problem when cathinones and synthetic cannabinoids started being sold at headshops.

vips7L 2y ago

I write software for this industry, the thought of not involving the FDA genuinely scares me.

ajot 2y ago
I do admin work for a pharma-related company. I would never want to be in charge of verifying with my own body what treatment is safe and/or effective. Drug development and clinical trials are expensive for a reason. Not doing them in an orderly manner is more expensive.
CamperBob2 2y ago
Fortunately, the position would be voluntary. You might be a big fan of the work the FDA does to keep us safe in light of past industry abuses, but keeping good drugs off the market - whether by outright fiat or by making them too expensive to develop, test, and deploy -- also has a terrible human cost. It's not clear that the FDA has found the right balance between risk reduction and upside potential.
- 0cf8612b2e1e 2y ago
  Drug development is a conservative industry. Even with researchers/companies/FDA all doing their best to develop good treatments, there are still many drug failures due to efficacy or safety. Being more lassiez faire is going to lead to direct harm of some patients. Is it a worthwhile tradeoff vs potentially addressing some unmet need is a tough calculus.
- hobermallow 2y ago
  What criteria would you suggest to measure in an effort to make it clear that the FDA has >found the right balance between risk reduction and upside potential?
  - CamperBob2 2y ago
    I don't think there's a good answer to that question, unfortunately. What we're doing now seems to be working for most people most of the time, but it'd be absurd to think there's no further room for optimization. And it seems unlikely that the best approach is more restrictive regulation, given that extremely-useful drugs are going undeveloped for decades. So... that leaves more flexible regulation as a worthwhile approach going forward. I like the idea of making limited human trials easier to carry out and less costly in general.
  - bdzr 2y ago
    Not OP, but it's certainly not by leaving drugs unapproved in the US that have been in wide use in Canada, England, Japan, etc for years (and in some cases decades). The incentives are so misaligned for the FDA that the bias for inaction is enormous. I also find it a bit patronizing that a federal agency determines whether or not a drug they've deemed safe has enough upside potential for me. That's a value judgement I'd like to make for myself. Sorry if this sounds harsh, but the FDA's inability to approve drugs inside of a decade has personally impacted me quite a bit.
BurningFrog 2y ago
One far less scary version is to allow drugs approved by other reputable agencies (EU, Japan, UK, maybe) to be used in some limited capacity in the US.
- ajot 2y ago
  From what I've heard from some friends working with regulatory agencies worldwide, this is currently the case or is about to happen. FDA-EMEA-(whatever the japanese regulatory agency's called) have agreements for treatments approved in one of the other two agencies to be easily approved.
- zerkten 2y ago
  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.
    - 2y ago

paulmd 2y ago

that already exists, it’s called doing research chemicals. You can do survodutide or whatever other next-gen drug right now and “do your own research” on the supply chain and efficacy and safety. They’re everywhere and functionally the FDA can’t stop you. should that be officially legitimized in any way by the FDA? fuck no. As soon as you break down the barrier in any way, companies will spring up exploiting it and promising miracle cures etc. even if you want to do RCs the FDA keeping a minimal wall there benefits you.

zoklet-enjoyer 2y ago
Agreed. RCs were great when you had to know what you were doing to get them. It only became a problem when cathinones and synthetic cannabinoids started being sold at headshops.