6 ms·

I don’t know why this isn’t a case where human subjects for the tests aren’t allowed.

by whycome 1y ago

qwertytyyuu 1y ago
This test shows effectiveness, they also need to go through trials to test for safety and unintended side effects
- adastra22 1y ago
  That’s actually the reverse order (and this trial didn’t test efficacy in humans).
  - Dylan16807 1y ago
    > That’s actually the reverse order I'd say that depends on how effective something is. If a treatment makes significant changes to most of the patients, you can have sufficient effectiveness proof before you're halfway done with the phase 1 safety trial.
jpollock 1y ago
If the disease is severe enough to justify an untested treatment with unknown toxicity they aren't aware enough to grant consent.
- harry8 1y ago
  True. But they could give consent in advance. If this horrific disease progresses to the point where ... I give my consent for ... Subject to final approval from family member/doctor/whatever.
  - arijun 1y ago
    Isn't that what power of attorney already is?
    - jpollock 1y ago
      Power of attorney isn't unlimited These are untested treatments with unknown impacts. Consider playing Russian roulette with the patient. The risk isn't the same but the outcomes have the same range. From nothing to death.
  - Someone 1y ago
    > But they could give consent in advance. There is plenty of data that shows that people are bad judges of their future opinions. “If X happened to me, I wouldn’t want to live anymore” often turns out to not be true. That makes it questionably whether consent years or even months ago implies consent now. And yes, that is very problematic in cases such as Alzheimer’s where people cannot consent now.
  - lostlogin 1y ago
    Most dementia patients have good days and bad. If they consent one day, then don’t the next, what do you do?
- Suppafly 1y ago
  >they aren't aware enough to grant consent That's not really an obstacle, people in those situations have family members consent for all sorts of treatment already.
wahnfrieden 1y ago
Human can’t consent in this case but they can feel immense pain and suffering still in ways that failed experimentation could invoke. Which may be worse than further decay and eventual death.
- trallnag 1y ago
  In many countries it's fairly easy to consent to euthanization. So these people could consent to participation in the study followed by immediate euthanization if the experiment fails and something worse than further decay awaits, no?
  - wahnfrieden 1y ago
    Someone with advanced stage Alzheimer’s, enough to warrant early testing with new experimental treatments, cannot consent to anything
jryb 1y ago
You’re not seeing all the other candidate treatments that made things worse. If it just gives everyone a heart attack immediately the question would be, why didn’t you try this out on mice first?
- adastra22 1y ago
  My body, my choice. I get the restriction on marketing and selling until some degree of safety and perhaps efficacy is demonstrated. But I should be allowed to choose to take the treatment if offered for free, even without any previous study.
  - b112 1y ago
    The main reason for all of this, is scams. Nutjobs without any medical background making claims without any scientific evidence. Or scam artists putting sawdust from a "special tree" into a bottle, and saying it cured his aunt, so it will cure you! If you look at the history of such things, it's just a constant battle against people being fleeced out of money. Con artists (and some of these wear lab coats and are quite professional in appearance and speak) know that desperation means easy prey. It's disgusting, but there it is. And it wasn't just a little problem. It was a huge problem. If the legal framework we have in place was torn down, you'd see all that re-emerge in a second. I agree that there should indeed be a way to balance snail oil salesman techniques, with the choice of someone in a dire circumstance. I did once read that there are FDA approved methods to get in on early stage/pre-clinical trials. These are targeted for people with severe conditions. People aren't being heartless here. But at the same time, loved ones will litigate to get money back from scam artists. This also includes going after doctors or facilities or anyone willing to enable such actions. And if treatments go sideways, and no one validated that it was anything more than made up gibberish? The lawsuits will fly then, too. The cops may follow. And it should be this way Truth is, you are free to imbibe and consume anything you want. No one can really stop you. And whatever method is being used here, I'm sure you could replicate it, buy the hardware, and so on. You are free to do this. It's just that no one wants to help. So you are free.
    - 1y ago
adastra22 1y ago
[flagged]
coldtea 1y ago
Because instead of curing their Alzheimer it might cause them to die faster with big side-effects if it's not tested well first. Eventually they will be allowed and there will be a human trial. Not when they're still experimenting. Just because someone has Alzheimer doesn't mean they're automatically a lab test subject.
busyant 1y ago
Human trials may eventually be allowed, but I suspect that the results are preliminary and much work still needs to be done to assess the drug's safety before it makes it to humans. Let me tell you a story about a biotech startup that I worked at many moons ago. - We were trying to develop new antibiotics to treat certain bacterial infections. - We had created a new antibiotic that was chemically similar to an existing, commercially successful antibiotic. - But our drug was ~2-4× more potent at killing certain pathogenic bacteria than the existing med. - Sounds good for us, right? - Well, the commercially successful antibiotic was also toxic to humans if administered for "long" periods (it causes severe anemia if administered for 20+ days [I may not remember the precise details here]). - Therefore, we were concerned that if our drug was 2-4× more potent at killing the microbes, it might also be 2-4× more toxic to people. - To obtain approval for human tests, we had to run toxicity tests of our drug using several non-human species. Those results were mixed (toxic in some species, non-toxic in others), but we did eventually get approval. - Unfortunately, the original concerns were correct: our drug caused severe anemia within ~3 days (again, specifics may be wrong), which means that particular candidate died in Phase 1 (initial human trial assessing drug safety). Thankfully, the severe anemia was reversible in our test subjects (stop taking the drug, and the anemia went away)

I don’t know why this isn’t a case where human subjects for the tests aren’t allowed.

qwertytyyuu 1y ago

This test shows effectiveness, they also need to go through trials to test for safety and unintended side effects

adastra22 1y ago
That’s actually the reverse order (and this trial didn’t test efficacy in humans).
- Dylan16807 1y ago
  > That’s actually the reverse order I'd say that depends on how effective something is. If a treatment makes significant changes to most of the patients, you can have sufficient effectiveness proof before you're halfway done with the phase 1 safety trial.

jpollock 1y ago

If the disease is severe enough to justify an untested treatment with unknown toxicity they aren't aware enough to grant consent.

harry8 1y ago
True. But they could give consent in advance. If this horrific disease progresses to the point where ... I give my consent for ... Subject to final approval from family member/doctor/whatever.
- arijun 1y ago
  Isn't that what power of attorney already is?
  - jpollock 1y ago
    Power of attorney isn't unlimited These are untested treatments with unknown impacts. Consider playing Russian roulette with the patient. The risk isn't the same but the outcomes have the same range. From nothing to death.
- Someone 1y ago
  > But they could give consent in advance. There is plenty of data that shows that people are bad judges of their future opinions. “If X happened to me, I wouldn’t want to live anymore” often turns out to not be true. That makes it questionably whether consent years or even months ago implies consent now. And yes, that is very problematic in cases such as Alzheimer’s where people cannot consent now.
- lostlogin 1y ago
  Most dementia patients have good days and bad. If they consent one day, then don’t the next, what do you do?
Suppafly 1y ago
>they aren't aware enough to grant consent That's not really an obstacle, people in those situations have family members consent for all sorts of treatment already.

wahnfrieden 1y ago

Human can’t consent in this case but they can feel immense pain and suffering still in ways that failed experimentation could invoke. Which may be worse than further decay and eventual death.

trallnag 1y ago
In many countries it's fairly easy to consent to euthanization. So these people could consent to participation in the study followed by immediate euthanization if the experiment fails and something worse than further decay awaits, no?
- wahnfrieden 1y ago
  Someone with advanced stage Alzheimer’s, enough to warrant early testing with new experimental treatments, cannot consent to anything

jryb 1y ago

You’re not seeing all the other candidate treatments that made things worse. If it just gives everyone a heart attack immediately the question would be, why didn’t you try this out on mice first?

adastra22 1y ago
My body, my choice. I get the restriction on marketing and selling until some degree of safety and perhaps efficacy is demonstrated. But I should be allowed to choose to take the treatment if offered for free, even without any previous study.
- b112 1y ago
  The main reason for all of this, is scams. Nutjobs without any medical background making claims without any scientific evidence. Or scam artists putting sawdust from a "special tree" into a bottle, and saying it cured his aunt, so it will cure you! If you look at the history of such things, it's just a constant battle against people being fleeced out of money. Con artists (and some of these wear lab coats and are quite professional in appearance and speak) know that desperation means easy prey. It's disgusting, but there it is. And it wasn't just a little problem. It was a huge problem. If the legal framework we have in place was torn down, you'd see all that re-emerge in a second. I agree that there should indeed be a way to balance snail oil salesman techniques, with the choice of someone in a dire circumstance. I did once read that there are FDA approved methods to get in on early stage/pre-clinical trials. These are targeted for people with severe conditions. People aren't being heartless here. But at the same time, loved ones will litigate to get money back from scam artists. This also includes going after doctors or facilities or anyone willing to enable such actions. And if treatments go sideways, and no one validated that it was anything more than made up gibberish? The lawsuits will fly then, too. The cops may follow. And it should be this way Truth is, you are free to imbibe and consume anything you want. No one can really stop you. And whatever method is being used here, I'm sure you could replicate it, buy the hardware, and so on. You are free to do this. It's just that no one wants to help. So you are free.
  - 1y ago

adastra22 1y ago

[flagged]

coldtea 1y ago

Because instead of curing their Alzheimer it might cause them to die faster with big side-effects if it's not tested well first. Eventually they will be allowed and there will be a human trial. Not when they're still experimenting. Just because someone has Alzheimer doesn't mean they're automatically a lab test subject.

busyant 1y ago

Human trials may eventually be allowed, but I suspect that the results are preliminary and much work still needs to be done to assess the drug's safety before it makes it to humans. Let me tell you a story about a biotech startup that I worked at many moons ago. - We were trying to develop new antibiotics to treat certain bacterial infections. - We had created a new antibiotic that was chemically similar to an existing, commercially successful antibiotic. - But our drug was ~2-4× more potent at killing certain pathogenic bacteria than the existing med. - Sounds good for us, right? - Well, the commercially successful antibiotic was also toxic to humans if administered for "long" periods (it causes severe anemia if administered for 20+ days [I may not remember the precise details here]). - Therefore, we were concerned that if our drug was 2-4× more potent at killing the microbes, it might also be 2-4× more toxic to people. - To obtain approval for human tests, we had to run toxicity tests of our drug using several non-human species. Those results were mixed (toxic in some species, non-toxic in others), but we did eventually get approval. - Unfortunately, the original concerns were correct: our drug caused severe anemia within ~3 days (again, specifics may be wrong), which means that particular candidate died in Phase 1 (initial human trial assessing drug safety). Thankfully, the severe anemia was reversible in our test subjects (stop taking the drug, and the anemia went away)