4 ms·

Thalidomide was widely approved, and I'm glad the FDA didn't rubber stamp it.

chroma 3y ago
But that’s the problem. No regulatory body has perfect judgement, so they’ll all approve some harmful things and ban some helpful things. If you’re so strict that you don’t allow thalidomide, you’ll also ban stuff like beta blockers for an extra decade, causing 80,000 deaths. The argument in favor of loosening restrictions is that it would reduce overall death and suffering.
- maxbond 3y ago
  If you think the fact that thalidomide, a deadly and basically worthless medication, being successfully blocked by the FDA is an example of a problem, then I'm a bit baffled? If you think that regulatory bodies make mistakes - then surely you want them checking each other's work? It's very frustrating to feel you are dying just shy of a breakthrough that can save you. I get that. And the author's contention, that they have a right as a human being to join studies that can potentially save them, is entirely reasonable. But that's an entire universe apart from rubber stamping medications. We should not give the pharmaceutical industry that much credulity. If pharmaceuticals have improved the length and quality of our lives, it's because they've been kept on the straight and narrow. This isn't a self regulating industry, they have a desperate base of customers and their "sales people" (doctors) are trusted implicitly - they hold a tremendous amount of power and would abuse it at the drop of a hat.
  - dghughes 3y ago
    > thalidomide, a deadly and basically worthless medication, Thalidomide is what is used to treat erythema nodosum leprosum (ENL) better known as just leprosy.
    - maxbond 3y ago
      It used to be regarded as a miracle drug that could be used over the counter in many circumstances, and as they looked into it they discovered it just couldn't be used safely. That they've narrowed it down to some use case is more of a testament to the thoroughness of the investigation, I'm sure there are many chemicals that could treat leprosy this just happens to be the one we understand how to manufacture and when it is safe to use. I'm sure it's very meaningful for the people who do take it, but that is what I meant by "basically worthless."
      - nradov 3y ago
        You are obviously deeply and aggressively ignorant about pharmacology. Thalidomide is an effective immunomodulator which is prescribed for multiple conditions beyond just leprosy. https://medlineplus.gov/druginfo/meds/a699032.html https://medlineplus.gov/druginfo/meds/a699032.html As with any medication there are risks and side effects but that hardly makes it "worthless".
        dang 3y ago
        Hey, please omit personal attacks and swipes from your comments, as the site guidelines ask: https://news.ycombinator.com/newsguidelines.html https://news.ycombinator.com/newsguidelines.html. Your comment would be just fine without that first sentence. Edit: it looks like we've had to warn you about this many times in the past—for example: https://news.ycombinator.com/item?id=32737135 https://news.ycombinator.com/item?id=32737135 (Sept 2022) https://news.ycombinator.com/item?id=30120252 https://news.ycombinator.com/item?id=30120252 (Jan 2022) https://news.ycombinator.com/item?id=29598017 https://news.ycombinator.com/item?id=29598017 (Dec 2021) https://news.ycombinator.com/item?id=25935223 https://news.ycombinator.com/item?id=25935223 (Jan 2021) We end up having to ban accounts that keep doing this and don't listen to warnings. I don't want to ban you, so please fix this!
        deleted 3y ago
        [deleted]
    - tux3 3y ago
      That's true, though I'll note that treatment options seem to have broadened a bit [0]. Thalidomide is effective, but suffers from cost and limited availability (in addition to the teratogenic effects). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7413435/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7413435/
    - morelisp 3y ago
      It's not been recommended in decades.
  - chroma 3y ago
    I’m saying that the FDA’s strictness cuts both ways. My beta blocker example was not a hypothetical. Europe approved the use of beta blockers to prevent heart attacks a decade before the US. Although the FDA approved propranolol in the 1960s, and timolol for glaucoma in 1978, they didn’t approve beta blockers for prevention of second heart attacks until the 1980s. This resulted in the deaths of over 80,000 Americans. Amusingly the New York Times article about this approval brags about how many people will be helped by the previously-banned medicine.[1] Nowhere is it pointed out that so many more people could have been saved if the FDA fast-tracked drugs approved in Europe. 1. https://www.nytimes.com/1982/02/02/science/new-class-of-drugs-revolutionizes-therap-y-for-heart-disease.html https://www.nytimes.com/1982/02/02/science/new-class-of-drug...
    - maxbond 3y ago
      It's one thing to say they should approve drugs faster and another thing to say they should rubber stamp anything that Europe and Canada approve.
      - chroma 3y ago
        It seems that if the Canadian and European regulatory bodies are incompetent or too quick to approve meds, it would show up in some statistics, right? Maybe their life expectancies would be lower or they would have higher rates of certain kinds of deaths. Yet if anything, it’s the US that lags in those areas. There are tons of examples of the FDA failing to approve things, resulting in Americans dying unnecessarily. A more recent example was Omegaven, an IV nutritional fluid.[1] The FDA took 14 years to approve it, resulting in hundreds of infant deaths. Before its approval, only a few infants at Boston Children’s Hospital managed to get it. The staff there had to get FDA approval to import the fluid from Europe for every infant they wanted to treat, resulting in a lag time of several days. Even though it was clear that Omegaven was much more effective than previous IV nutrition, the FDA’s bureaucratic hurdles prevented it from being adopted sooner. 1. https://astralcodexten.substack.com/p/adumbrations-of-aducanumab https://astralcodexten.substack.com/p/adumbrations-of-aducan...
        3y ago
wbl 3y ago
The FDA can approve a new drug in under a year as we saw with covid vaccines. Every time an effective drug is made and they don't people die waiting.
- maxbond 3y ago
  They approved one drug in under a year in a literal emergency (and it's deeply controversial that they did even that). That doesn't mean they can do that with everything that crosses their desk. I do buy the author's assertion that people should have right to expose themselves to experimental medicines when it could save their lives though.
  - wbl 3y ago
    Why doesn't it mean that?
    - maxbond 3y ago
      Let's say I give you 10 tasks. You're going to have to go back and forth with external stakeholders, and a given task will be blocked much of the time waiting for a response. So you can do each of them concurrently, but it's gunnuh take a year to do each of them. But the next day I come to you with an 11th task. I tell you this is the only one that matters. I give you full license to blow through your budget, harass people until they get their paperwork done, whatever it takes - this is the only priority. So you get right to work, and with all the blockers cleared you get it done in 6 months. "Great," I say, "so you can do all them that fast right? And when I come back in 6 months, all of the original 10 tasks will be done?" But of course they won't be, because you don't have the resources you had before, the external stakeholders aren't as motivated as they were before, and instead of putting all your effort into 1 task you're going to be spreading it across 10.
      - wbl 3y ago
        The external stakeholders in the FDA are extremely motivated to get approval quickly. If this is a resource problem then the case for increasing the budget is clear.
theflyingelvis 3y ago
I take a derivative, Lenalidomide, for cancer maintenance. I am very glad the FDA approved it.
arrosenberg 3y ago
Sure, but they did rubber stamp Fen-phen and Vioxx despite plenty of people within the FDA understanding it should come with a black box warning. The FDA needs a win that's more recent than 1971 if they want to demonstrate their efficacy as regulators.

But that’s the problem. No regulatory body has perfect judgement, so they’ll all approve some harmful things and ban some helpful things. If you’re so strict that you don’t allow thalidomide, you’ll also ban stuff like beta blockers for an extra decade, causing 80,000 deaths. The argument in favor of loosening restrictions is that it would reduce overall death and suffering.

maxbond 3y ago
If you think the fact that thalidomide, a deadly and basically worthless medication, being successfully blocked by the FDA is an example of a problem, then I'm a bit baffled? If you think that regulatory bodies make mistakes - then surely you want them checking each other's work? It's very frustrating to feel you are dying just shy of a breakthrough that can save you. I get that. And the author's contention, that they have a right as a human being to join studies that can potentially save them, is entirely reasonable. But that's an entire universe apart from rubber stamping medications. We should not give the pharmaceutical industry that much credulity. If pharmaceuticals have improved the length and quality of our lives, it's because they've been kept on the straight and narrow. This isn't a self regulating industry, they have a desperate base of customers and their "sales people" (doctors) are trusted implicitly - they hold a tremendous amount of power and would abuse it at the drop of a hat.
- dghughes 3y ago
  > thalidomide, a deadly and basically worthless medication, Thalidomide is what is used to treat erythema nodosum leprosum (ENL) better known as just leprosy.
  - maxbond 3y ago
    It used to be regarded as a miracle drug that could be used over the counter in many circumstances, and as they looked into it they discovered it just couldn't be used safely. That they've narrowed it down to some use case is more of a testament to the thoroughness of the investigation, I'm sure there are many chemicals that could treat leprosy this just happens to be the one we understand how to manufacture and when it is safe to use. I'm sure it's very meaningful for the people who do take it, but that is what I meant by "basically worthless."
    - nradov 3y ago
      You are obviously deeply and aggressively ignorant about pharmacology. Thalidomide is an effective immunomodulator which is prescribed for multiple conditions beyond just leprosy. https://medlineplus.gov/druginfo/meds/a699032.html https://medlineplus.gov/druginfo/meds/a699032.html As with any medication there are risks and side effects but that hardly makes it "worthless".
      - dang 3y ago
        Hey, please omit personal attacks and swipes from your comments, as the site guidelines ask: https://news.ycombinator.com/newsguidelines.html https://news.ycombinator.com/newsguidelines.html. Your comment would be just fine without that first sentence. Edit: it looks like we've had to warn you about this many times in the past—for example: https://news.ycombinator.com/item?id=32737135 https://news.ycombinator.com/item?id=32737135 (Sept 2022) https://news.ycombinator.com/item?id=30120252 https://news.ycombinator.com/item?id=30120252 (Jan 2022) https://news.ycombinator.com/item?id=29598017 https://news.ycombinator.com/item?id=29598017 (Dec 2021) https://news.ycombinator.com/item?id=25935223 https://news.ycombinator.com/item?id=25935223 (Jan 2021) We end up having to ban accounts that keep doing this and don't listen to warnings. I don't want to ban you, so please fix this!
      - deleted 3y ago
        [deleted]
  - tux3 3y ago
    That's true, though I'll note that treatment options seem to have broadened a bit [0]. Thalidomide is effective, but suffers from cost and limited availability (in addition to the teratogenic effects). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7413435/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7413435/
  - morelisp 3y ago
    It's not been recommended in decades.
- chroma 3y ago
  I’m saying that the FDA’s strictness cuts both ways. My beta blocker example was not a hypothetical. Europe approved the use of beta blockers to prevent heart attacks a decade before the US. Although the FDA approved propranolol in the 1960s, and timolol for glaucoma in 1978, they didn’t approve beta blockers for prevention of second heart attacks until the 1980s. This resulted in the deaths of over 80,000 Americans. Amusingly the New York Times article about this approval brags about how many people will be helped by the previously-banned medicine.[1] Nowhere is it pointed out that so many more people could have been saved if the FDA fast-tracked drugs approved in Europe. 1. https://www.nytimes.com/1982/02/02/science/new-class-of-drugs-revolutionizes-therap-y-for-heart-disease.html https://www.nytimes.com/1982/02/02/science/new-class-of-drug...
  - maxbond 3y ago
    It's one thing to say they should approve drugs faster and another thing to say they should rubber stamp anything that Europe and Canada approve.
    - chroma 3y ago
      It seems that if the Canadian and European regulatory bodies are incompetent or too quick to approve meds, it would show up in some statistics, right? Maybe their life expectancies would be lower or they would have higher rates of certain kinds of deaths. Yet if anything, it’s the US that lags in those areas. There are tons of examples of the FDA failing to approve things, resulting in Americans dying unnecessarily. A more recent example was Omegaven, an IV nutritional fluid.[1] The FDA took 14 years to approve it, resulting in hundreds of infant deaths. Before its approval, only a few infants at Boston Children’s Hospital managed to get it. The staff there had to get FDA approval to import the fluid from Europe for every infant they wanted to treat, resulting in a lag time of several days. Even though it was clear that Omegaven was much more effective than previous IV nutrition, the FDA’s bureaucratic hurdles prevented it from being adopted sooner. 1. https://astralcodexten.substack.com/p/adumbrations-of-aducanumab https://astralcodexten.substack.com/p/adumbrations-of-aducan...
      - 3y ago

wbl 3y ago

The FDA can approve a new drug in under a year as we saw with covid vaccines. Every time an effective drug is made and they don't people die waiting.

maxbond 3y ago
They approved one drug in under a year in a literal emergency (and it's deeply controversial that they did even that). That doesn't mean they can do that with everything that crosses their desk. I do buy the author's assertion that people should have right to expose themselves to experimental medicines when it could save their lives though.
- wbl 3y ago
  Why doesn't it mean that?
  - maxbond 3y ago
    Let's say I give you 10 tasks. You're going to have to go back and forth with external stakeholders, and a given task will be blocked much of the time waiting for a response. So you can do each of them concurrently, but it's gunnuh take a year to do each of them. But the next day I come to you with an 11th task. I tell you this is the only one that matters. I give you full license to blow through your budget, harass people until they get their paperwork done, whatever it takes - this is the only priority. So you get right to work, and with all the blockers cleared you get it done in 6 months. "Great," I say, "so you can do all them that fast right? And when I come back in 6 months, all of the original 10 tasks will be done?" But of course they won't be, because you don't have the resources you had before, the external stakeholders aren't as motivated as they were before, and instead of putting all your effort into 1 task you're going to be spreading it across 10.
    - wbl 3y ago
      The external stakeholders in the FDA are extremely motivated to get approval quickly. If this is a resource problem then the case for increasing the budget is clear.

theflyingelvis 3y ago

I take a derivative, Lenalidomide, for cancer maintenance. I am very glad the FDA approved it.

arrosenberg 3y ago

Sure, but they did rubber stamp Fen-phen and Vioxx despite plenty of people within the FDA understanding it should come with a black box warning. The FDA needs a win that's more recent than 1971 if they want to demonstrate their efficacy as regulators.