7 ms·

> If you decouple availability from effectiveness then drug companies will just market unproven drugs to people who are desperate or who don't know any better.

> If you decouple availability from effectiveness then drug companies will just market unproven drugs to people who are desperate or who don't know any better. Or even if the drug companies do nothing people will just start taking drugs on the basis of recommendations from Facebook. But this already happens for certain treatments. The FDA already regulates a separate category with loose efficacy requirements for dietary supplements and herbal remedies. These medically irrelevant treatments are immensely popular, they're just forbidden from marketing specific medical claims and being actually toxic. People still end up taking FDA approved treatments like Ivermectin for non-FDA-approved purposes based on Facebook recommendations. Why do we always have to make people's choices for them? They're grown adults capable of making their own decisions and their own mistakes. If they want to ignore the science and the credibility of the FDA process, they should be free to do so.

Brakenshire 5y ago
One big reason is you're removing the economic incentive to produce good evidence. The herbal remedies industry is a perfect example, there will be valid treatments there but yet the industry is almost entirely medically useless. Some of the treatments might be effective for particular diseases, at particular doses but no one ever knows. These companies have billions in revenue and are vastly profitable but they never look for evidence that treatments work because people buy the remedies anyway, and a company that spent the money to run the trials would be undercut by less scrupulous competition. This is not even a market with asymmetry of knowledge, it's a market where no one knows anything, and the lack of regulation makes sure it continues that way.
- themacguffinman 5y ago
  There's still an economic incentive for the highest level of FDA approval: Medicare and insurance companies have to cover it and doctors can prescribe it. That ensures a high and consistent level of usage across the whole country, not just among people with more money than sense (usually IMHO; it's possible that they're just smarter & savvier than the notoriously conservative FDA, who knows, this is a big reason why taking away choice is bad on principle). I don't think the lack of credible evidence of efficacy in the supplement market is for lack of trying. If an alternative medicine is actually effective, it just becomes medicine that the majority of people can trust and use.
heavyset_go 5y ago
> But this already happens for certain treatments. The FDA already regulates a separate category with loose efficacy requirements for dietary supplements and herbal remedies. These medically irrelevant treatments are immensely popular, they're just forbidden from marketing specific medical claims and being actually toxic. In the US, supplements must be vitamins or minerals, botanical products, amino acids or enzyme products. Drug companies can't develop a new compound and then try to sell it as a supplement unless it meets those requirements, which it probably won't, because drug companies rarely develop new compounds that are also found in nature or in your body already.
- setgree 5y ago
  To quote another SA piece, “the categories were made for man, not man for the categories” https://slatestarcodex.com/2014/11/21/the-categories-were-made-for-man-not-man-for-the-categories/ https://slatestarcodex.com/2014/11/21/the-categories-were-ma... OP is saying we could change the laws that configure the distinction you draw.
kelnos 5y ago
> Why do we always have to make people's choices for them? They're grown adults capable of making their own decisions and their own mistakes. If they want to ignore the science and the credibility of the FDA process, they should be free to do so. Most people -- including myself -- are unequipped to evaluate the science behind most drugs. That supposed to be why the FDA exists. I do not want to make my own mistakes here, since they can very easily be fatal, or at least have long-term consequences. I want a trusted body of experts to give me a recommendation that's as well-informed and unbiased as possible. The FDA may or may not be as good as they should be at being that body, but it is absolutely needed.
- themacguffinman 5y ago
  This thread is about decoupling efficacy from safety, not releasing potentially fatal treatments. The whole point of Scott's article is that we can keep basic safety requirements but the efficacy requirements for FDA approval are much stricter and should be decoupled. The FDA can give a lower level of approval to treatments like this Alzheimer one that has controversial/borderline efficacy evidence instead of making a black & white choice between "not allowed at all" and "fully endorsed and must be covered by Medicare & insurance". No one is arguing to get rid of safety requirements or the FDA. The FDA will still be empowered to give a recommendation based on efficacy, but the lack of an efficacy recommendation should not prevent people from getting a treatment. The FDA is necessarily conservative, slow, and sometimes makes mistakes. That has a real cost if it acts as the sole gatekeeper for efficacy, a prime example being early COVID-19 test kits.
  - andrekandre 5y ago
    why would we want to sell drugs that are "safe" but ineffective? imagine someone is in need of an effective treatment, but they don't like it or heard some rumors on tv or youtube, then instead they take an ineffective drug and think they aren't contagious, yet now they are potential spreaders of a disease... that doesn't sound safe at all to me.
    - themacguffinman 5y ago
dlp211 5y ago
> Why do we always have to make people's choices for them? They're grown adults capable of making their own decisions and their own mistakes. If they want to ignore the science and the credibility of the FDA process, they should be free to do so. Because I am not a scientist and need an authoritative body that I can have some semblance of trust in to decide what medicine I can put in my body and a Dr can prescribe to me. And we have tried the unregulated route before and we had people taking cough syrup with heroine in it and other snake oils. I mean, even with the FDA, we have people using animal dosage de-wormer to treat Covid with no evidence that it works and a lot of evidence that it will fuck up your guts...so as much as you want to play the "we're adults capable of making decisions" card, that statement really doesn't mean much in reality.
- themacguffinman 5y ago
  Is anyone even reading my comment or any of the comments above me? I'm not arguing against the FDA's safety requirements. The argument is for decoupling safety from efficacy requirements to make a treatment available to acquire. Right now availability is coupled with mandatory coverage by Medicare & insurance, which means treatments with borderline/controversial efficacy results like this Alzheimer one is either totally banned or mandatory for prescription & coverage. You wouldn't be able to sell heroin.
  - HarryHirsch 5y ago
    decoupling safety from efficacy requirements to make a treatment available to acquire That'll only serve to increase distrust in the FDA. Yeah, it's safe, but also, it's no good for anything. You wonder if that's the purpose of such initiatives, destroying trust in the public authorities to better be able to sell snake oil.
    - themacguffinman 5y ago
      I'm sure that people who can read an FDA safety-only mark clearly labelled as safety-only will be just fine. The benefits of separating them are relevant to this exact Alzheimer treatment; It has controversial efficacy, but now the FDA had to decide between "all doctors, insurance, and Medicare must cover/prescribe it" or "no one is allowed to do anything with it". It will also serve to speed up the notoriously slow and expensive process to make something available and make grey-area treatments available. This completely fucked the FDA's early response to the initial need for COVID-19 testing kits. The FDA made a mistake as all organizations do, but its approval system is so inflexible it prevented many safe and realistically effective testing kits from being made available.
andrekandre 5y ago
> They're grown adults capable of making their own decisions and their own mistakes. in a society, "ones own mistakes" can have effects on those around you (e.g mask wearing, vaccine (not)taking, spreading misinformation etc) which can result in unintentional hospitalization or death of others we dont live in isolated bubbles, so there is a limit to how far we can go with putting everything on the shelf and let everyone do what they want with it
tsimionescu 5y ago
> Why do we always have to make people's choices for them? They're grown adults capable of making their own decisions and their own mistakes. If they want to ignore the science and the credibility of the FDA process, they should be free to do so. Because desperate sick people and their loved ones make excellent marks. Without standards, some doctor or medical company will milk every last penny from someone with the false promise of some sort of hope. Not to mention second order effects. The more common it is for medicine to be seen not working, the more people will distrust the medical system.
- themacguffinman 5y ago
  A treatment that is safe but not proven by the FDA to be effective would not be part of the medical system (ie. doctors, insurance, Medicare), just an available and minimally safe product. People are already "milked" on supplements and herbal remedies (which is at least still regulated to be safe, not necessarily true for a lot of informal quackery out there): people buy a lot of them without FDA approval or a medical prescription in the hopes that it somehow helps them. It's just fine. Rigorous FDA approval has & will always be available for people to use. They're grown adults, let them make that decision. If people distrust the medical system because products outside the medical system have failed them, well, people are allowed to be stupid.

Brakenshire 5y ago

One big reason is you're removing the economic incentive to produce good evidence. The herbal remedies industry is a perfect example, there will be valid treatments there but yet the industry is almost entirely medically useless. Some of the treatments might be effective for particular diseases, at particular doses but no one ever knows. These companies have billions in revenue and are vastly profitable but they never look for evidence that treatments work because people buy the remedies anyway, and a company that spent the money to run the trials would be undercut by less scrupulous competition. This is not even a market with asymmetry of knowledge, it's a market where no one knows anything, and the lack of regulation makes sure it continues that way.

themacguffinman 5y ago
There's still an economic incentive for the highest level of FDA approval: Medicare and insurance companies have to cover it and doctors can prescribe it. That ensures a high and consistent level of usage across the whole country, not just among people with more money than sense (usually IMHO; it's possible that they're just smarter & savvier than the notoriously conservative FDA, who knows, this is a big reason why taking away choice is bad on principle). I don't think the lack of credible evidence of efficacy in the supplement market is for lack of trying. If an alternative medicine is actually effective, it just becomes medicine that the majority of people can trust and use.

heavyset_go 5y ago

> But this already happens for certain treatments. The FDA already regulates a separate category with loose efficacy requirements for dietary supplements and herbal remedies. These medically irrelevant treatments are immensely popular, they're just forbidden from marketing specific medical claims and being actually toxic. In the US, supplements must be vitamins or minerals, botanical products, amino acids or enzyme products. Drug companies can't develop a new compound and then try to sell it as a supplement unless it meets those requirements, which it probably won't, because drug companies rarely develop new compounds that are also found in nature or in your body already.

setgree 5y ago
To quote another SA piece, “the categories were made for man, not man for the categories” https://slatestarcodex.com/2014/11/21/the-categories-were-made-for-man-not-man-for-the-categories/ https://slatestarcodex.com/2014/11/21/the-categories-were-ma... OP is saying we could change the laws that configure the distinction you draw.

kelnos 5y ago

> Why do we always have to make people's choices for them? They're grown adults capable of making their own decisions and their own mistakes. If they want to ignore the science and the credibility of the FDA process, they should be free to do so. Most people -- including myself -- are unequipped to evaluate the science behind most drugs. That supposed to be why the FDA exists. I do not want to make my own mistakes here, since they can very easily be fatal, or at least have long-term consequences. I want a trusted body of experts to give me a recommendation that's as well-informed and unbiased as possible. The FDA may or may not be as good as they should be at being that body, but it is absolutely needed.

themacguffinman 5y ago
This thread is about decoupling efficacy from safety, not releasing potentially fatal treatments. The whole point of Scott's article is that we can keep basic safety requirements but the efficacy requirements for FDA approval are much stricter and should be decoupled. The FDA can give a lower level of approval to treatments like this Alzheimer one that has controversial/borderline efficacy evidence instead of making a black & white choice between "not allowed at all" and "fully endorsed and must be covered by Medicare & insurance". No one is arguing to get rid of safety requirements or the FDA. The FDA will still be empowered to give a recommendation based on efficacy, but the lack of an efficacy recommendation should not prevent people from getting a treatment. The FDA is necessarily conservative, slow, and sometimes makes mistakes. That has a real cost if it acts as the sole gatekeeper for efficacy, a prime example being early COVID-19 test kits.
- andrekandre 5y ago
  why would we want to sell drugs that are "safe" but ineffective? imagine someone is in need of an effective treatment, but they don't like it or heard some rumors on tv or youtube, then instead they take an ineffective drug and think they aren't contagious, yet now they are potential spreaders of a disease... that doesn't sound safe at all to me.
  - themacguffinman 5y ago

dlp211 5y ago

> Why do we always have to make people's choices for them? They're grown adults capable of making their own decisions and their own mistakes. If they want to ignore the science and the credibility of the FDA process, they should be free to do so. Because I am not a scientist and need an authoritative body that I can have some semblance of trust in to decide what medicine I can put in my body and a Dr can prescribe to me. And we have tried the unregulated route before and we had people taking cough syrup with heroine in it and other snake oils. I mean, even with the FDA, we have people using animal dosage de-wormer to treat Covid with no evidence that it works and a lot of evidence that it will fuck up your guts...so as much as you want to play the "we're adults capable of making decisions" card, that statement really doesn't mean much in reality.

themacguffinman 5y ago
Is anyone even reading my comment or any of the comments above me? I'm not arguing against the FDA's safety requirements. The argument is for decoupling safety from efficacy requirements to make a treatment available to acquire. Right now availability is coupled with mandatory coverage by Medicare & insurance, which means treatments with borderline/controversial efficacy results like this Alzheimer one is either totally banned or mandatory for prescription & coverage. You wouldn't be able to sell heroin.
- HarryHirsch 5y ago
  decoupling safety from efficacy requirements to make a treatment available to acquire That'll only serve to increase distrust in the FDA. Yeah, it's safe, but also, it's no good for anything. You wonder if that's the purpose of such initiatives, destroying trust in the public authorities to better be able to sell snake oil.
  - themacguffinman 5y ago
    I'm sure that people who can read an FDA safety-only mark clearly labelled as safety-only will be just fine. The benefits of separating them are relevant to this exact Alzheimer treatment; It has controversial efficacy, but now the FDA had to decide between "all doctors, insurance, and Medicare must cover/prescribe it" or "no one is allowed to do anything with it". It will also serve to speed up the notoriously slow and expensive process to make something available and make grey-area treatments available. This completely fucked the FDA's early response to the initial need for COVID-19 testing kits. The FDA made a mistake as all organizations do, but its approval system is so inflexible it prevented many safe and realistically effective testing kits from being made available.

andrekandre 5y ago

> They're grown adults capable of making their own decisions and their own mistakes. in a society, "ones own mistakes" can have effects on those around you (e.g mask wearing, vaccine (not)taking, spreading misinformation etc) which can result in unintentional hospitalization or death of others we dont live in isolated bubbles, so there is a limit to how far we can go with putting everything on the shelf and let everyone do what they want with it

tsimionescu 5y ago

themacguffinman 5y ago
A treatment that is safe but not proven by the FDA to be effective would not be part of the medical system (ie. doctors, insurance, Medicare), just an available and minimally safe product. People are already "milked" on supplements and herbal remedies (which is at least still regulated to be safe, not necessarily true for a lot of informal quackery out there): people buy a lot of them without FDA approval or a medical prescription in the hopes that it somehow helps them. It's just fine. Rigorous FDA approval has & will always be available for people to use. They're grown adults, let them make that decision. If people distrust the medical system because products outside the medical system have failed them, well, people are allowed to be stupid.