5 ms·

> Demands for increasingly byzantine trials This is silly. FDA has essentially one requirement: prove that your drug is safe and effective. The reason trial

> Demands for increasingly byzantine trials This is silly. FDA has essentially one requirement: prove that your drug is safe and effective. The reason trial designs get more and more byzantine is because the drugs themselves work less-and-less well. They're far more nuanced and precise. The experiments have to be extremely well-controlled, and then this has to balance against cost/timeline of the trial, and that's why sponsors choose to use byzantine trial designs.

A_D_E_P_T 4mo ago
Proving "efficacy" -- which is the difficult and expensive part -- should not be necessary, and the government increasingly moves its own goalposts as to what the word efficacy even means. Simple as that. Postmarketing surveillance can easily determine what's effective and what's not, and medical orgs can adjust.
- estearum 4mo ago
  Brilliant idea. This way both actual working drugs and vitamin-aisle potions look identical to consumers. Neither (or both?) can make claims to their effectiveness since they're both backed by the same (lack of) actual knowledge. This is especially great because it puts anyone who actually wants to actually make a working drug at a significant disadvantage. It'll take them longer to get to market, cost them a billion dollars more, then their medicine gets to sit next to a thousand variations of "Vitamin C for Leukemia" that all cost a lot less. There would be virtually no incentive for anyone to make an actual drug. > Postmarketing surveillance can easily determine what's effective and what's not, and medical orgs can adjust. "Easily" is doing a ton of work. Postmarketing surveillance can sometimes give low-confidence signal as to what's effective and what's not.
  - qsera 4mo ago
    >There would be virtually no incentive for anyone to make an actual drug. Dumb question: Wouldn't the market discover what works and what does not automatically, like any other product?
    - estearum 4mo ago
      Sure, in the same way "the market" discovered that cigarettes cause significant health problems. Step 1. Ensure extremely widespread use to ensure that effects are noticed relatively quickly (i.e. within a few decades) Step 2. Hope someone notices correlations between that drug use and the positive/negative downstream effects. Step 3. Hope someone who has access to the data required to actually conduct an observational study actually wants to run the observational study. By the way, you better hope all the info you need is available in insurance claims data (it's not) because that's really the only data you'll have at high scale. For most of these fraudulent drugs, you won't even have that! Because why would you go through the hassle of gaining reimbursement when you can just sell bullshit for cash? So in practice the required real-world data on these drugs and their effects literally will not exist in most cases. Where the data does exist, it'll be confounded by the unrecorded use of all the other fake drugs too. Step 4. Hope the company selling a non-working drug doesn't have the clever idea of publishing countervailing "studies" backed by much larger budgets and with more existential motivation. They won't be assessed by FDA so these studies can just say whatever they want, of course. Step 5. Lobby for outlawing of a drug that, in fact, didn't break any law whatsoever. Obviously it can't be illegal to sell a non-working in a regime that has no way to assess whether a drug works. So you really just gotta hope to post enough times that a drug is bad that people stop taking it. But cigarettes' negative effects are significantly stronger than most drugs' positive (or negative) effects. So every single step is going to be dramatically harder, require more people taking the drug, more data, more time, more sophisticated analysis, more direct scrutiny from "the market." Give it a few decades and, maybe a couple hundred or couple thousand deaths, and with a bit of luck "the market" will have eliminated one of the thousands of fake drugs proliferating across the market. Thankfully for the company behind it, they can always just start up another totally legal fraud by just picking a different chemical (inert or not) and claiming a different medical benefit. Oh yeah, meanwhile, doctors are just flooded with absolute bullshit claims 24/7 with no repercussions for anyone just lying to them. It's good stuff. Literally one of the dumbest ideas I've ever heard.
      - qsera 4mo ago
        Not sure, I was just talking about the efficacy, not long term side effects. The parent comment was also talking about showing efficacy... >Literally one of the dumbest ideas I've ever heard. It is capitalism 101. Not sure if that is the dumbest idea, because the whole world seem to run on it.

A_D_E_P_T 4mo ago

Proving "efficacy" -- which is the difficult and expensive part -- should not be necessary, and the government increasingly moves its own goalposts as to what the word efficacy even means. Simple as that. Postmarketing surveillance can easily determine what's effective and what's not, and medical orgs can adjust.

estearum 4mo ago
Brilliant idea. This way both actual working drugs and vitamin-aisle potions look identical to consumers. Neither (or both?) can make claims to their effectiveness since they're both backed by the same (lack of) actual knowledge. This is especially great because it puts anyone who actually wants to actually make a working drug at a significant disadvantage. It'll take them longer to get to market, cost them a billion dollars more, then their medicine gets to sit next to a thousand variations of "Vitamin C for Leukemia" that all cost a lot less. There would be virtually no incentive for anyone to make an actual drug. > Postmarketing surveillance can easily determine what's effective and what's not, and medical orgs can adjust. "Easily" is doing a ton of work. Postmarketing surveillance can sometimes give low-confidence signal as to what's effective and what's not.
- qsera 4mo ago
  >There would be virtually no incentive for anyone to make an actual drug. Dumb question: Wouldn't the market discover what works and what does not automatically, like any other product?
  - estearum 4mo ago
    Sure, in the same way "the market" discovered that cigarettes cause significant health problems. Step 1. Ensure extremely widespread use to ensure that effects are noticed relatively quickly (i.e. within a few decades) Step 2. Hope someone notices correlations between that drug use and the positive/negative downstream effects. Step 3. Hope someone who has access to the data required to actually conduct an observational study actually wants to run the observational study. By the way, you better hope all the info you need is available in insurance claims data (it's not) because that's really the only data you'll have at high scale. For most of these fraudulent drugs, you won't even have that! Because why would you go through the hassle of gaining reimbursement when you can just sell bullshit for cash? So in practice the required real-world data on these drugs and their effects literally will not exist in most cases. Where the data does exist, it'll be confounded by the unrecorded use of all the other fake drugs too. Step 4. Hope the company selling a non-working drug doesn't have the clever idea of publishing countervailing "studies" backed by much larger budgets and with more existential motivation. They won't be assessed by FDA so these studies can just say whatever they want, of course. Step 5. Lobby for outlawing of a drug that, in fact, didn't break any law whatsoever. Obviously it can't be illegal to sell a non-working in a regime that has no way to assess whether a drug works. So you really just gotta hope to post enough times that a drug is bad that people stop taking it. But cigarettes' negative effects are significantly stronger than most drugs' positive (or negative) effects. So every single step is going to be dramatically harder, require more people taking the drug, more data, more time, more sophisticated analysis, more direct scrutiny from "the market." Give it a few decades and, maybe a couple hundred or couple thousand deaths, and with a bit of luck "the market" will have eliminated one of the thousands of fake drugs proliferating across the market. Thankfully for the company behind it, they can always just start up another totally legal fraud by just picking a different chemical (inert or not) and claiming a different medical benefit. Oh yeah, meanwhile, doctors are just flooded with absolute bullshit claims 24/7 with no repercussions for anyone just lying to them. It's good stuff. Literally one of the dumbest ideas I've ever heard.
    - qsera 4mo ago
      Not sure, I was just talking about the efficacy, not long term side effects. The parent comment was also talking about showing efficacy... >Literally one of the dumbest ideas I've ever heard. It is capitalism 101. Not sure if that is the dumbest idea, because the whole world seem to run on it.