4 ms·

I mean, if you have an aggressively terminal disease with no known cure, I think the risk-reward calculus is somewhat different from the average drug The issue

by advael 2y ago

I mean, if you have an aggressively terminal disease with no known cure, I think the risk-reward calculus is somewhat different from the average drug The issue, as comes up incessantly in all manner of situations, is the way we regulate drugs as a whole. A lack of safety testing should mean a higher standard of informed consent should be used, not that it should be illegal for someone to get ahold of it I see lots of benefit to regulatory agencies controlling what claims can be made about medications and holding people selling them to account for quality control failures. Agencies preventing consenting adults from making their own risk-reward calculations does badly on both principle and outcomes

scott_w 2y ago
While I agree that my calculation on safety would be different for a terminal illness for which no cure exists, we still need to be careful. The very nature of this situation creates desperate people who are willing to ignore a simple warning label in favour of hope. Any system / regulator still needs to force companies to prove their treatment has the claimed effect, and block any that simply don't. On safety, I think there's more wiggle room, however. Treatment here can be based on likely ill effects vs the known effects of the illness of the patient.
- advael 2y ago
  Nah, I actually think the effectiveness standard is far worse than the safety standard due to what a "block" means and how "effectiveness" is tested. An RCT, the gold standard by which medicines are often tested, can easily show a negligible effect size because of the vast confound space of individual differences. A medicine that works perfectly for many of a study's participants will be considered "ineffective" routinely And hey, in cases like that I think the regulators should absolutely have the power to say "selling this without explaining these caveats is criminal fraud", but not that people can't try the drug anyway if informed of the risks and low likelihood of success as determined by the agency's analysis In an effort to standardize process and appease large incumbent industry players (often, as here, by erecting enormous entry barriers in front of lucrative markets), we frequently create metrics that are too blunt and remedies that favor governments flexing disproportionate power over the lives and choices of individuals
  - scott_w 2y ago
    I think this risks creating a perverse incentive where actually creating a cure is hard but looking like you maybe, sometimes, if you squint just right, cure the illness is easy. So companies start to ignore those hard cures in favour of sugar pills with warning labels on.
    - advael 2y ago
      You can already do that though. There's a massive essentially unregulated market full of "supplements" and "alternative medicine" and "faith healing" you can play in if you're dedicated to the business of scamming people who don't look at claims skeptically, including but not limited to people who have terminal diseases. This regulatory process does absolutely nothing to prevent that. However, due to the broad authority of agencies like the FDA and DEA to outlaw drugs that demonstrably do something, we are left with a situation where most of what gets shut down is actual useful medicine
      - scott_w 2y ago
        There’s a big difference between a black market existing and the government throwing its hands up and saying “let’s just legalise it!” Weak regulation that allows non-medical products to masquerade as medicine is not the same as “nothing can be done.” Things absolutely can be done.
        advael 2y ago
        These aren't black markets, and they're frankly not regulation failures either. Regulatory bodies serve an important role in creating a standard people can rely on for claims that things work as medicine. They should not serve the role of making it so that people can't get their hands on things at all if the regulatory body doesn't deem them effective. If a person can see that a treatment is not FDA-approved and decides to try it anyway, the FDA's hands are clean. The failure is that if someone tries and fails to get their treatment approved, it's often more illegal to sell it than if they just claimed it worked without trying to go through the proper channels This situation is made even worse by the Controlled Substances Act and the Analogue Act, which not only artificially restrict both supply and access to a ton of effective medications, but also create this onerous donuthole where a substance can be shown to be effective enough to warrant criminalization, but not pass the rigorous standards to be approved as medicine. It would be a lot better for everyone but enormous pharmaceutical monopolies and police states if we kept regulatory bodies' role to quality control, an official standard by which medical claims could be judged as a guide for laypeople, and fraud prevention.

by advael 2y ago

scott_w 2y ago

While I agree that my calculation on safety would be different for a terminal illness for which no cure exists, we still need to be careful. The very nature of this situation creates desperate people who are willing to ignore a simple warning label in favour of hope. Any system / regulator still needs to force companies to prove their treatment has the claimed effect, and block any that simply don't. On safety, I think there's more wiggle room, however. Treatment here can be based on likely ill effects vs the known effects of the illness of the patient.

advael 2y ago
Nah, I actually think the effectiveness standard is far worse than the safety standard due to what a "block" means and how "effectiveness" is tested. An RCT, the gold standard by which medicines are often tested, can easily show a negligible effect size because of the vast confound space of individual differences. A medicine that works perfectly for many of a study's participants will be considered "ineffective" routinely And hey, in cases like that I think the regulators should absolutely have the power to say "selling this without explaining these caveats is criminal fraud", but not that people can't try the drug anyway if informed of the risks and low likelihood of success as determined by the agency's analysis In an effort to standardize process and appease large incumbent industry players (often, as here, by erecting enormous entry barriers in front of lucrative markets), we frequently create metrics that are too blunt and remedies that favor governments flexing disproportionate power over the lives and choices of individuals
- scott_w 2y ago
  I think this risks creating a perverse incentive where actually creating a cure is hard but looking like you maybe, sometimes, if you squint just right, cure the illness is easy. So companies start to ignore those hard cures in favour of sugar pills with warning labels on.
  - advael 2y ago
    You can already do that though. There's a massive essentially unregulated market full of "supplements" and "alternative medicine" and "faith healing" you can play in if you're dedicated to the business of scamming people who don't look at claims skeptically, including but not limited to people who have terminal diseases. This regulatory process does absolutely nothing to prevent that. However, due to the broad authority of agencies like the FDA and DEA to outlaw drugs that demonstrably do something, we are left with a situation where most of what gets shut down is actual useful medicine
    - scott_w 2y ago
      There’s a big difference between a black market existing and the government throwing its hands up and saying “let’s just legalise it!” Weak regulation that allows non-medical products to masquerade as medicine is not the same as “nothing can be done.” Things absolutely can be done.
      - advael 2y ago
        These aren't black markets, and they're frankly not regulation failures either. Regulatory bodies serve an important role in creating a standard people can rely on for claims that things work as medicine. They should not serve the role of making it so that people can't get their hands on things at all if the regulatory body doesn't deem them effective. If a person can see that a treatment is not FDA-approved and decides to try it anyway, the FDA's hands are clean. The failure is that if someone tries and fails to get their treatment approved, it's often more illegal to sell it than if they just claimed it worked without trying to go through the proper channels This situation is made even worse by the Controlled Substances Act and the Analogue Act, which not only artificially restrict both supply and access to a ton of effective medications, but also create this onerous donuthole where a substance can be shown to be effective enough to warrant criminalization, but not pass the rigorous standards to be approved as medicine. It would be a lot better for everyone but enormous pharmaceutical monopolies and police states if we kept regulatory bodies' role to quality control, an official standard by which medical claims could be judged as a guide for laypeople, and fraud prevention.