4 ms·

> This is not a call to attack on the FDA At this point, I honestly think that we'd be much better off without an FDA at all. It costs >$2B to develop a drug.

> This is not a call to attack on the FDA At this point, I honestly think that we'd be much better off without an FDA at all. It costs >$2B to develop a drug. Most of this is on account of efficacy testing -- phases 2 and 3 of the drug development process -- which are nearly impossible to run. And when drugs exhibit poor or nil efficacy, the FDA sometimes approves them anyway, making the entire process unprincipled. See, e.g., flibanserin, aduhelm, and others. The result is total regulatory capture. If you're a small firm -- a biotech startup -- you quite literally can't introduce a new drug to the market. Your only hope is to push it through preclinical trials and then partner with -- or get bought out by -- a large "prime" like Pfizer which specializes in regulatory compliance and has the deep pockets required. Back in the 1940s and 1950s, there were lots of small firms that competed in drug development. Syntex, for instance. That was a period the industry still calls "The Golden Age of Drug Development," and it would be utterly impossible to recreate today. All of this is without even going into the bureaucratic hurdles which delay new treatments from reaching patients, the chilling effect that the red tape has on pharmaceutical R&D, the way they gatekeep generics, and I could go on all day. It's not just a bad system, it might be among the worst systems possible, as it concentrates all power and all wealth in the hands of a few -- and the patients are the ones who suffer for it.

vinnyvichy 2y ago
I hear you..
Palomides 2y ago
it's very bureaucratic, but I'm curious what phases of the process you think we can skip? was the golden age entirely due to lack of procedural burden, or just low hanging fruit? I agree that it's all a miserable mess, for sure, the solutions are just unclear to me; the relationship between the public and those developing drugs is increasingly hostile due to the need for blockbuster hits and really questionable effect sizes that get pushed due to sunk costs
- A_D_E_P_T 2y ago
  Efficacy testing -- those phases 2 and 3 -- are entirely unnecessary. They didn't exist prior to 1962's Thalidomide backlash, ironically despite the fact that Thalidomide failed safety testing in the US and was not approved for use. So it's simple: After phase 1 safety testing, allow drugs to be marketed, but mandate postmarketing surveillance for a period of 5 years to try and tease out real-world safety, efficacy, and drug interactions. This would ultimately result in a better and safer system, as quite a lot of drugs have problems that aren't revealed in phases 2/3 anyway. (e.g. rosiglitazone.) This simple fix would not only speed up drug development, it would also make drug development a lot cheaper. Compared to the current paradigm, it would heavily incentivize R&D, and bright young minds might see the development of therapeutics as something potentially rewarding. Whereas, today, nobody in their right mind wants to get into pharmaceutical development when they could be making much more money, with much less red tape, in tech.
  - Palomides 2y ago
    how would someone under such a system decide to take a drug or not? what information would they have?
    - JackFr 2y ago
      Insurance companies would decide. Raise your hand if you think that would be better.
      - wins32767 2y ago
        The largest single payer in the US is the Federal government. Medicare, Medicaid, Tricare, the VA... The problem won't be fixed for the vast majority of expenditures because the government will need to perform the same function the FDA is now for it's drug costs.
      - A_D_E_P_T 2y ago
        Maybe. But cheaper drug development should also make for cheaper drugs, which will weaken the stranglehold the insurance companies have on drug supply and distribution.
yawnxyz 2y ago
I'm drug discovery and the FDA absolutely _does_ keep all the crazies in check. Many people died during that golden age, and don't forget that the same golden age produced many of the problems we're drowning in / trying to fix today (PFAS, etc.)
- A_D_E_P_T 2y ago
  > Many people died during that golden age I've written about this before. Basically, the FDA's position is that it's better for 10,000 patients to die of neglect than have 1 patient die of quackery. Drug development is in shambles because the FDA requires >99.99% confidence that pharmaceutical companies are not selling quack cures. Do we need that level of confidence? Especially for cancer, is that degree of confidence warranted? Is the process efficient? There's legitimate fear of quack medicine -- and then there's whatever the FDA is gripped by, which seems to me a lot like insanity. > PFAS Not exactly something that goes through the usual drug approval process. What other problems come to mind?
  - ansible 2y ago
    There's a lot of quackery around these days, especially with regard to tech and finance. There's quite of bit of quackery just with nutritional supplements, too. And people and companies try to bypass the FDA all the time with fake cures, the COVID-19 epidemic was just the latest version of that. The FDA is over-zealous with their testing requirements. However, without them we will see an explosion of fake cures for everything. The legitimate pharma companies will lose money, or otherwise start cutting a lot of corners in the pursuit of profit. We need something like the FDA to keep things in check.
- vinnyvichy 2y ago
  I tried to upvote both of you to keep this civil.. I think there are important points to consider on both sides -- and I find this repartee between you and A_D_E_P_T most informed! it might take some time to reconcile your points though, some moderate data might help, what do I know, being peripheral to drug-development..
- 2y ago

vinnyvichy 2y ago

I hear you..

Palomides 2y ago

it's very bureaucratic, but I'm curious what phases of the process you think we can skip? was the golden age entirely due to lack of procedural burden, or just low hanging fruit? I agree that it's all a miserable mess, for sure, the solutions are just unclear to me; the relationship between the public and those developing drugs is increasingly hostile due to the need for blockbuster hits and really questionable effect sizes that get pushed due to sunk costs

A_D_E_P_T 2y ago
Efficacy testing -- those phases 2 and 3 -- are entirely unnecessary. They didn't exist prior to 1962's Thalidomide backlash, ironically despite the fact that Thalidomide failed safety testing in the US and was not approved for use. So it's simple: After phase 1 safety testing, allow drugs to be marketed, but mandate postmarketing surveillance for a period of 5 years to try and tease out real-world safety, efficacy, and drug interactions. This would ultimately result in a better and safer system, as quite a lot of drugs have problems that aren't revealed in phases 2/3 anyway. (e.g. rosiglitazone.) This simple fix would not only speed up drug development, it would also make drug development a lot cheaper. Compared to the current paradigm, it would heavily incentivize R&D, and bright young minds might see the development of therapeutics as something potentially rewarding. Whereas, today, nobody in their right mind wants to get into pharmaceutical development when they could be making much more money, with much less red tape, in tech.
- Palomides 2y ago
  how would someone under such a system decide to take a drug or not? what information would they have?
  - JackFr 2y ago
    Insurance companies would decide. Raise your hand if you think that would be better.
    - wins32767 2y ago
      The largest single payer in the US is the Federal government. Medicare, Medicaid, Tricare, the VA... The problem won't be fixed for the vast majority of expenditures because the government will need to perform the same function the FDA is now for it's drug costs.
    - A_D_E_P_T 2y ago
      Maybe. But cheaper drug development should also make for cheaper drugs, which will weaken the stranglehold the insurance companies have on drug supply and distribution.

yawnxyz 2y ago

I'm drug discovery and the FDA absolutely _does_ keep all the crazies in check. Many people died during that golden age, and don't forget that the same golden age produced many of the problems we're drowning in / trying to fix today (PFAS, etc.)

A_D_E_P_T 2y ago
> Many people died during that golden age I've written about this before. Basically, the FDA's position is that it's better for 10,000 patients to die of neglect than have 1 patient die of quackery. Drug development is in shambles because the FDA requires >99.99% confidence that pharmaceutical companies are not selling quack cures. Do we need that level of confidence? Especially for cancer, is that degree of confidence warranted? Is the process efficient? There's legitimate fear of quack medicine -- and then there's whatever the FDA is gripped by, which seems to me a lot like insanity. > PFAS Not exactly something that goes through the usual drug approval process. What other problems come to mind?
- ansible 2y ago
  There's a lot of quackery around these days, especially with regard to tech and finance. There's quite of bit of quackery just with nutritional supplements, too. And people and companies try to bypass the FDA all the time with fake cures, the COVID-19 epidemic was just the latest version of that. The FDA is over-zealous with their testing requirements. However, without them we will see an explosion of fake cures for everything. The legitimate pharma companies will lose money, or otherwise start cutting a lot of corners in the pursuit of profit. We need something like the FDA to keep things in check.
vinnyvichy 2y ago
I tried to upvote both of you to keep this civil.. I think there are important points to consider on both sides -- and I find this repartee between you and A_D_E_P_T most informed! it might take some time to reconcile your points though, some moderate data might help, what do I know, being peripheral to drug-development..
2y ago