9 ms·

Discussed here fifteen days ago: https://news.ycombinator.com/item?id=29882912 https://news.ycombinator.com/item?id=29882912 Not a huge update but an interesti

Discussed here fifteen days ago: https://news.ycombinator.com/item?id=29882912 https://news.ycombinator.com/item?id=29882912 Not a huge update but an interesting discussion of FDA approval; can the FDA actually stop or sanction experimental procedures like this?

hprotagonist 5y ago
>can the FDA actually stop or sanction experimental procedures like this? They explicitly permitted this operation, by means of https://www.fda.gov/news-events/public-health-focus/expanded-access https://www.fda.gov/news-events/public-health-focus/expanded... Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.
jostmey 5y ago
Yes, the FDA will insert itself to regulate medicine wherever it can. For example, the FDA has been pushing to regulate diagnostic tests as medical devices. It’s funny how Americans surrender medical autonomy to the government but draw a strict line in the sand in other issues
- e-clinton 5y ago
  Everyone who isn’t an HCP “surrenders” medical autonomy since not everyone pretends to know better than the experts.
  - captainredbeard 5y ago
    HCPs love the idea of declaring autonomy as outdated, or problematic, or even better, an HCP behavior itself. Dream on.
- giantg2 5y ago
  Some of us realize it's straight up politics, but we have no power. It's not a choice, but a reality we live with.
- hallway_monitor 5y ago
  If there was indeed a way to pull back the scope and power granted to the government I think a lot of us Americans would love to hear about it. The way it is, it seems like the US government is an unstoppable machine that will grow until it destroys itself.
  - 0xedd 5y ago
    One of the amendments is supposed to shield you from tyranny. But, going down a less risky path, I'd vote (no pun) for migration. My parents migrated away from a country that trades in humans to this day, in full view of the gov, and i can't be thankful enough.
  - nicoburns 5y ago
    I don’t think the American governments biggest problem is it’s scope and power: I think it’s biggest problem is inefficiency due to corruption (regulatory capture, etc). It seems to me that the biggest obstacle to fixing this is that many Americans see this as an inevitable character of government rather than something specific to their system, and thus spend their time trying to reduce government (ironically making it even less effective by hobbling it with silly restrictions) rather than fixing it into a well functioning system.
    - cobbzilla 5y ago
      The two are interrelated — regulatory capture doesn’t make sense if there’s no power to capture. So one must first grow the size and power of government through other means, then capture/influence that power. This cycle has been going on for a long time.
- mlindner 5y ago
  That's actually why we're against it. Once they have the power it's basically impossible to recall it. There were many lines in the sand in the past and they keep being crossed.
- Klinky 5y ago
  It's funny how susceptible Americans are to medical misinformation. The FDA is a necessity.
- pjc50 5y ago
  > regulate diagnostic tests If only there hadn't been a major high profile collapse of a fraudulent diagnostic test company recently.
  - neuronic 5y ago
    The hostility towards FDA on HN is incredible. I wouldn't trust some VC funded startup bros with anything related to medicine at all without having passed every single regulatory board tangentially related to whatever they are doing, even more so after Theranos.
    - DrAwdeOccarim 5y ago
      I don’t sense hostility outside the typical vocal minority. Having straddled the FDA-regulated world and the libertarian-leaning internet cultures through the aughts and teens, my experience is that the internet libertarians are simply ignorant of how the FDA actually serves us. Pretty typically libertarian—freedom as long as nothing gets more dangerous. Kind of like rebellious children.
      - ryandrake 5y ago
        > Pretty typically libertarian—freedom as long as nothing gets more dangerous. Kind of like rebellious children. Or, as this guy[1] put it, like house cats. “convinced of their fierce independence while utterly dependent on a system they don’t appreciate or understand.” As a former Libertarian who luckily grew out of that phase, I love this analogy. 1: https://twitter.com/jspauldingphoto/status/1461506998118330374 https://twitter.com/jspauldingphoto/status/14615069981183303...
        DrAwdeOccarim 5y ago
        Yea, that’s a good one!
      - sjg007 5y ago
        HN had a huge sophomoric Randian streak years ago.. It seems to be maturing as I assume the users age.
- aqme28 5y ago
  Is that a recent push? I used to work for a company producing a diagnostic test, and it was being regulated as you said. But what is the issue with that? Failures in diagnosis kill people very regularly. It should be regulated.
- baldfat 5y ago
  I have a weird muscle disease that is treated with just taking over the counter L-Carnitine. The issue, vitamins and supplements are not regulated. So, I will try to take a new brand and after a few days my symptoms will come back because the pills don't have the L-Carnitine like it says and there is no one to make sure it does. It will cost me four to seven days of pain, and no one is held responsible. My best guess is one in a thousand actually needs them so the 999 have a placebo effect and the 1 suffers. I told my neurologist, and he couldn't even prescribe them for me because that isn't a thing. So now I buy all I can find that works and hope they don't stop making it.
  - JohnJamesRambo 5y ago
    Do you have any proof the supplements don’t have l-carnitine? You should get a lawyer if so, that is an easy case against the supplement maker imo.
    - jolux 5y ago
      The whole supplements industry is like this. The best you can do is get one that’s USP certified.
  - treeman79 5y ago
    I had to spend thousands to go through a dozen medications for medical issues. Eventually turned to supplements in part because it was much easier to experiment. I have a couple meds and treatments I’ve been begging doctors to try, but they aren’t aware of them so refuse to consider. Go onto any support forum and you’ll find countless tales of doctors not listening or not knowing current info on a condition.
    - Workaccount2 5y ago
      You'll also find tons of people who swear by their home "witches brew" medication. People who are just feeling a placebo. Or people who think they have the forum's banner illness but actually have something totally different and much more benign. They heal over time naturally, but attribute it to gum root jelly concentrate. I've been there a few times before. And while inevitably monkeys popping random pills will find something, separating the signal from the noise takes time and studies. The things that doctors pay attention too. Disclaimer: Yes there are out of touch doctors and yes random medicating has lead to amazing discoveries.
- Beltalowda 5y ago
  > For example, the FDA has been pushing to regulate diagnostic tests as medical devices. I assume you mean COVID home tests and things like that? Call me strange, but if I buy such a thing then I'd like to make sure it's held to some standard of accuracy and safety. I do not have the resources or knowledge to find this out myself. Most people don't, and you can't just rely on "internet reviews" or the like. Someone has to do this, and while the FDA and government authority may not be perfect, they're the best we've got, and we can at least somewhat hold them accountable through the democratic process (which also isn't perfect, but better than anything else we've got).
  - malfist 5y ago
    Right? Like why shouldn't they regulate diagnostic tests? Do you expect the free market to do it?
  - ethbr0 5y ago
    I'm surprised by the popular take on this. Hasn't HN spent the last 3 years lamenting how the FAA ceded too much regulatory power to industry? ... because this is where it starts. The answer to "there are regulatory inefficiencies" is not "get rid of regulations" or "allow industry to self-regulate."
- raxxorrax 5y ago
  Private companies also rely on the state for liability reasons as we just now saw with the vaccines. I believe overall this is a good idea to have high expectations for medical procedures as it does not inhibit progress.
- Cthulhu_ 5y ago
  > It’s funny how Americans surrender medical autonomy to the government but draw a strict line in the sand in other issues You're implying that all ~332 million Americans are a homogenous and single-minded mass. Please stop generalizing, it's not a good look.
- mlinhares 5y ago
  All you need is a conservative talking head to kickstart resistance to that as well, they just have to figure out a way of making money out of it.
- throwaway0a5e 5y ago
  >It’s funny how Americans surrender medical autonomy to the government but draw a strict line in the sand in other issues If they knew the extent of it they probably wouldn't. I don't know where you're from but I'm sure the people there show equal apathy on some subjects.
- sandworm101 5y ago
  >> to regulate diagnostic tests as medical devices. Like MIR machines? Like blood labs? Like home pregnancy tests? Without the FDA's regulation of medicine we would quickly be back to snake oil and cocaine in everything. It is bad enough that drugs stores are allowed to sell water as a "homeopathic remedy". The snake oil people are out there waiting for deregulation.

hprotagonist 5y ago

>can the FDA actually stop or sanction experimental procedures like this? They explicitly permitted this operation, by means of https://www.fda.gov/news-events/public-health-focus/expanded-access https://www.fda.gov/news-events/public-health-focus/expanded... Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.

jostmey 5y ago

Yes, the FDA will insert itself to regulate medicine wherever it can. For example, the FDA has been pushing to regulate diagnostic tests as medical devices. It’s funny how Americans surrender medical autonomy to the government but draw a strict line in the sand in other issues

e-clinton 5y ago
Everyone who isn’t an HCP “surrenders” medical autonomy since not everyone pretends to know better than the experts.
- captainredbeard 5y ago
  HCPs love the idea of declaring autonomy as outdated, or problematic, or even better, an HCP behavior itself. Dream on.
giantg2 5y ago
Some of us realize it's straight up politics, but we have no power. It's not a choice, but a reality we live with.
hallway_monitor 5y ago
If there was indeed a way to pull back the scope and power granted to the government I think a lot of us Americans would love to hear about it. The way it is, it seems like the US government is an unstoppable machine that will grow until it destroys itself.
- 0xedd 5y ago
  One of the amendments is supposed to shield you from tyranny. But, going down a less risky path, I'd vote (no pun) for migration. My parents migrated away from a country that trades in humans to this day, in full view of the gov, and i can't be thankful enough.
- nicoburns 5y ago
  I don’t think the American governments biggest problem is it’s scope and power: I think it’s biggest problem is inefficiency due to corruption (regulatory capture, etc). It seems to me that the biggest obstacle to fixing this is that many Americans see this as an inevitable character of government rather than something specific to their system, and thus spend their time trying to reduce government (ironically making it even less effective by hobbling it with silly restrictions) rather than fixing it into a well functioning system.
  - cobbzilla 5y ago
    The two are interrelated — regulatory capture doesn’t make sense if there’s no power to capture. So one must first grow the size and power of government through other means, then capture/influence that power. This cycle has been going on for a long time.
mlindner 5y ago
That's actually why we're against it. Once they have the power it's basically impossible to recall it. There were many lines in the sand in the past and they keep being crossed.
Klinky 5y ago
It's funny how susceptible Americans are to medical misinformation. The FDA is a necessity.
pjc50 5y ago
> regulate diagnostic tests If only there hadn't been a major high profile collapse of a fraudulent diagnostic test company recently.
- neuronic 5y ago
  The hostility towards FDA on HN is incredible. I wouldn't trust some VC funded startup bros with anything related to medicine at all without having passed every single regulatory board tangentially related to whatever they are doing, even more so after Theranos.
  - DrAwdeOccarim 5y ago
    I don’t sense hostility outside the typical vocal minority. Having straddled the FDA-regulated world and the libertarian-leaning internet cultures through the aughts and teens, my experience is that the internet libertarians are simply ignorant of how the FDA actually serves us. Pretty typically libertarian—freedom as long as nothing gets more dangerous. Kind of like rebellious children.
    - ryandrake 5y ago
      > Pretty typically libertarian—freedom as long as nothing gets more dangerous. Kind of like rebellious children. Or, as this guy[1] put it, like house cats. “convinced of their fierce independence while utterly dependent on a system they don’t appreciate or understand.” As a former Libertarian who luckily grew out of that phase, I love this analogy. 1: https://twitter.com/jspauldingphoto/status/1461506998118330374 https://twitter.com/jspauldingphoto/status/14615069981183303...
      - DrAwdeOccarim 5y ago
        Yea, that’s a good one!
    - sjg007 5y ago
      HN had a huge sophomoric Randian streak years ago.. It seems to be maturing as I assume the users age.
aqme28 5y ago
Is that a recent push? I used to work for a company producing a diagnostic test, and it was being regulated as you said. But what is the issue with that? Failures in diagnosis kill people very regularly. It should be regulated.
baldfat 5y ago
I have a weird muscle disease that is treated with just taking over the counter L-Carnitine. The issue, vitamins and supplements are not regulated. So, I will try to take a new brand and after a few days my symptoms will come back because the pills don't have the L-Carnitine like it says and there is no one to make sure it does. It will cost me four to seven days of pain, and no one is held responsible. My best guess is one in a thousand actually needs them so the 999 have a placebo effect and the 1 suffers. I told my neurologist, and he couldn't even prescribe them for me because that isn't a thing. So now I buy all I can find that works and hope they don't stop making it.
- JohnJamesRambo 5y ago
  Do you have any proof the supplements don’t have l-carnitine? You should get a lawyer if so, that is an easy case against the supplement maker imo.
  - jolux 5y ago
    The whole supplements industry is like this. The best you can do is get one that’s USP certified.
- treeman79 5y ago
  I had to spend thousands to go through a dozen medications for medical issues. Eventually turned to supplements in part because it was much easier to experiment. I have a couple meds and treatments I’ve been begging doctors to try, but they aren’t aware of them so refuse to consider. Go onto any support forum and you’ll find countless tales of doctors not listening or not knowing current info on a condition.
  - Workaccount2 5y ago
    You'll also find tons of people who swear by their home "witches brew" medication. People who are just feeling a placebo. Or people who think they have the forum's banner illness but actually have something totally different and much more benign. They heal over time naturally, but attribute it to gum root jelly concentrate. I've been there a few times before. And while inevitably monkeys popping random pills will find something, separating the signal from the noise takes time and studies. The things that doctors pay attention too. Disclaimer: Yes there are out of touch doctors and yes random medicating has lead to amazing discoveries.
Beltalowda 5y ago
> For example, the FDA has been pushing to regulate diagnostic tests as medical devices. I assume you mean COVID home tests and things like that? Call me strange, but if I buy such a thing then I'd like to make sure it's held to some standard of accuracy and safety. I do not have the resources or knowledge to find this out myself. Most people don't, and you can't just rely on "internet reviews" or the like. Someone has to do this, and while the FDA and government authority may not be perfect, they're the best we've got, and we can at least somewhat hold them accountable through the democratic process (which also isn't perfect, but better than anything else we've got).
- malfist 5y ago
  Right? Like why shouldn't they regulate diagnostic tests? Do you expect the free market to do it?
- ethbr0 5y ago
  I'm surprised by the popular take on this. Hasn't HN spent the last 3 years lamenting how the FAA ceded too much regulatory power to industry? ... because this is where it starts. The answer to "there are regulatory inefficiencies" is not "get rid of regulations" or "allow industry to self-regulate."
raxxorrax 5y ago
Private companies also rely on the state for liability reasons as we just now saw with the vaccines. I believe overall this is a good idea to have high expectations for medical procedures as it does not inhibit progress.
Cthulhu_ 5y ago
> It’s funny how Americans surrender medical autonomy to the government but draw a strict line in the sand in other issues You're implying that all ~332 million Americans are a homogenous and single-minded mass. Please stop generalizing, it's not a good look.
mlinhares 5y ago
All you need is a conservative talking head to kickstart resistance to that as well, they just have to figure out a way of making money out of it.
throwaway0a5e 5y ago
>It’s funny how Americans surrender medical autonomy to the government but draw a strict line in the sand in other issues If they knew the extent of it they probably wouldn't. I don't know where you're from but I'm sure the people there show equal apathy on some subjects.
sandworm101 5y ago
>> to regulate diagnostic tests as medical devices. Like MIR machines? Like blood labs? Like home pregnancy tests? Without the FDA's regulation of medicine we would quickly be back to snake oil and cocaine in everything. It is bad enough that drugs stores are allowed to sell water as a "homeopathic remedy". The snake oil people are out there waiting for deregulation.