3 ms·

I'll note you can find past Hacker News discussions full of people suggesting the FDA's approval processes are overly burdensome.

whatshisface 3y ago
An approval process can be at once burdensome and vulnerable to the fraud Merck committed.
- nitwit005 3y ago
  Theoretically, but I don't think the people making those comments would be happy with the "fixed" more fraud resistant system either. Some of them expressed that people should be able to take unproven drugs (Libertarian philosophy). They're just okay with this happening from time to time.
  - whatshisface 3y ago
    I'm not here to tell anyone else their morals, but I do think telling doctors, "here's a chemical we figured out how to manufacture, let us know if you want more of it for some reason," would be ethically better than cooking the books to get FDA approval on that same chemical while knowing the side effects. In the former case doctors may commit an ethical violation themselves by presenting the drug as safe, but what did in fact happen was Merck did that, saving them the question.
    - mcguire 3y ago
      In the second case, you can hold the people who "cook[ed] the books to get FDA approval ... while knowing the side effects" responsible. In the first you cannot.
  - marcosdumay 3y ago
    > but I don't think the people making those comments would be happy with the "fixed" more fraud resistant system either Why do you assume this? Do you expect to fix fraudulent study results by mandating more studies? Any way to add flexibility to drug certification must necessarily include some ongoing procedure to verify it works. So, it's even hard to come out with a faster process that doesn't reduce this problem (but yeah, if you make an effort, you can make one).
    - mcguire 3y ago
      By "fixed", I believe the parent poster meant mandating fewer studies, as in zero.
      - marcosdumay 3y ago
        AFAIK nobody ever came out demanding the number of studies to be zero. Not even lunatic groups. The OP's strawman is is so obviously out of the cultural norm that it is screaming bad-faith construction. And if he wants to claim that merely reducing the number of studies run by the people interested on a positive result to a non-zero amount will increase the odds of fraud, well, I'd be interested on honest arguments, because it's a revolutionary finding on either system or game theory.
        mcguire 3y ago
        My friend, I've seen people here, on HN, writing that they would be happy with a medical doctor trained by YouTube videos. There are people here who have expressed the opinion that any form of regulation is a positive evil. And you can't have fraud if you don't have tests to pass fraudulently.
      - nitwit005 3y ago
        How exactly would ""fixed" more fraud resistant system" imply doing zero studies?
    - deleted 3y ago
      [deleted]
- mlhpdx 3y ago
  Fraud is a pretty light word. An overt act that results in someone’s death goes by some more serious words, and without a convenient statute of limitations pass.
llamaimperative 3y ago
“The COVID vaccine was ready after 3 days, FDA must be abolished!” - Otherwise reasonably intelligent people My buddy made a COVID vax, a cure for Alzheimer’s, and an age reversal suppository in his garage in less than a week. He pinky promises that they work ¯\_(ツ)_/¯ (FWIW the other commenter is right, it is possible the process is both excessively burdensome and vulnerable, but in general people leveling this “too burdensome” critique actually have no clue how drug development works and why it’s so hard)
amadeuspagel 3y ago
In many contexts, the way we deal with potential problems is allowing people to do things and punishing them when they fuck up. For example, it's relatively easy to get a drivers license, but if you run someone over, even by accident, you're held responsible. Maybe this is how we should deal with pharmacies as well.
- ggm 3y ago
  No. Absolutely not. It's being given a drivers licence and allowed to kill 20,000 people on your commute to work before being stopped.
  - amadeuspagel 3y ago
    I'm not saying that getting a license to sell a pharmacy should be just as easy as getting a drivers license, just that there's no contradiction between wanting licensing to be easier, and wanting people held responsible for damage.
deleted 3y ago
[deleted]

whatshisface 3y ago

An approval process can be at once burdensome and vulnerable to the fraud Merck committed.

nitwit005 3y ago
Theoretically, but I don't think the people making those comments would be happy with the "fixed" more fraud resistant system either. Some of them expressed that people should be able to take unproven drugs (Libertarian philosophy). They're just okay with this happening from time to time.
- whatshisface 3y ago
  I'm not here to tell anyone else their morals, but I do think telling doctors, "here's a chemical we figured out how to manufacture, let us know if you want more of it for some reason," would be ethically better than cooking the books to get FDA approval on that same chemical while knowing the side effects. In the former case doctors may commit an ethical violation themselves by presenting the drug as safe, but what did in fact happen was Merck did that, saving them the question.
  - mcguire 3y ago
    In the second case, you can hold the people who "cook[ed] the books to get FDA approval ... while knowing the side effects" responsible. In the first you cannot.
- marcosdumay 3y ago
  > but I don't think the people making those comments would be happy with the "fixed" more fraud resistant system either Why do you assume this? Do you expect to fix fraudulent study results by mandating more studies? Any way to add flexibility to drug certification must necessarily include some ongoing procedure to verify it works. So, it's even hard to come out with a faster process that doesn't reduce this problem (but yeah, if you make an effort, you can make one).
  - mcguire 3y ago
    By "fixed", I believe the parent poster meant mandating fewer studies, as in zero.
    - marcosdumay 3y ago
      AFAIK nobody ever came out demanding the number of studies to be zero. Not even lunatic groups. The OP's strawman is is so obviously out of the cultural norm that it is screaming bad-faith construction. And if he wants to claim that merely reducing the number of studies run by the people interested on a positive result to a non-zero amount will increase the odds of fraud, well, I'd be interested on honest arguments, because it's a revolutionary finding on either system or game theory.
      - mcguire 3y ago
        My friend, I've seen people here, on HN, writing that they would be happy with a medical doctor trained by YouTube videos. There are people here who have expressed the opinion that any form of regulation is a positive evil. And you can't have fraud if you don't have tests to pass fraudulently.
    - nitwit005 3y ago
      How exactly would ""fixed" more fraud resistant system" imply doing zero studies?
  - deleted 3y ago
    [deleted]
mlhpdx 3y ago
Fraud is a pretty light word. An overt act that results in someone’s death goes by some more serious words, and without a convenient statute of limitations pass.

llamaimperative 3y ago

“The COVID vaccine was ready after 3 days, FDA must be abolished!” - Otherwise reasonably intelligent people My buddy made a COVID vax, a cure for Alzheimer’s, and an age reversal suppository in his garage in less than a week. He pinky promises that they work ¯\_(ツ)_/¯ (FWIW the other commenter is right, it is possible the process is both excessively burdensome and vulnerable, but in general people leveling this “too burdensome” critique actually have no clue how drug development works and why it’s so hard)

amadeuspagel 3y ago

In many contexts, the way we deal with potential problems is allowing people to do things and punishing them when they fuck up. For example, it's relatively easy to get a drivers license, but if you run someone over, even by accident, you're held responsible. Maybe this is how we should deal with pharmacies as well.

ggm 3y ago
No. Absolutely not. It's being given a drivers licence and allowed to kill 20,000 people on your commute to work before being stopped.
- amadeuspagel 3y ago
  I'm not saying that getting a license to sell a pharmacy should be just as easy as getting a drivers license, just that there's no contradiction between wanting licensing to be easier, and wanting people held responsible for damage.

deleted 3y ago

[deleted]