15 ms·

They do not know the percent chance of death during early experimentation. They literally do not understand the procedure well enough to estimate the effects wi

by Veserv 3y ago

They do not know the percent chance of death during early experimentation. They literally do not understand the procedure well enough to estimate the effects with sufficient confidence for it to be acceptable to do in human subjects. That is why it is called early stage and why we have animal testing, to establish these parameters as best we can for it to be acceptable to attempt on humans. This is literally the blood the human clinical testing rules around consenting to procedures is written in.

Dylan16807 3y ago
And once they do enough animal testing, they can figure out a reasonable estimate for the danger. And they've probably done enough for that. The real barrier here is whether it's considered safe enough to let people volunteer, not just whether they can estimate the level of safety. There's a big range of experiments where informed consent is possible but it's not allowed because it's too dangerous. I think this testing is probably in that range. And anything in that range is not a matter of "capital E Evil". Evil is when you're not getting consent, or similar.
- Veserv 3y ago
  Yes, when they do enough animal testing. That is literally not the case the head neurosurgeon is postulating. Immediately before the quote they say that animal testing is the only available option during early stage. They have no other choice which is why they do it, but if the FDA allowed human experimentation during such early stages it would be a interesting option to pursue in lieu of animal testing. That is literally saying that if they had a procedure that is not ready for humans under existing rules, they would totally do it if the FDA stopped having rules against it.
  - Dylan16807 3y ago
    My understanding is that the existing rules require a lot more pre-human testing than is necessary if your only goal is a good estimate of the danger level. Trying to get closer to that amount, and risking more people, might be a bad idea but I would not call it evil.
  - s1artibartfast 3y ago
    It seems that you're discounting the possibility that this neurosurgeon thinks that the procedure and technology is sufficiently safe to move to human work in an ethical manner.
    - Veserv 3y ago
      Yeah, well the FDA does not think so and they have a pretty good track record on both safety and expedience when it matters as seen with the expedited COVID vaccine testing. Also, it is not like this is even new technology that requires bespoke safety analysis. There are tons of companies making intracranial implants to support brain computer interaction in human clinical testing and in deployment generally. Here [1] is one in 2016 of a man controlling a robotic arm to shake Obama’s hand with sensory feedback. In contrast, from what I have read Neuralink has used and killed over 10x the average number of animal test subjects and still failed to adequately characterize and reduce the risks to the standard level that literally dozens or hundreds of other researchers achieve routinely. They should ostensibly have 10x the data and experience yet they have failed to achieve even the minimal standard for the easiest step. So forgive me if I trust the FDA and their rules written in blood over the student who wants the test to be easier. [1] https://youtu.be/rqD-I1ehf5E https://youtu.be/rqD-I1ehf5E
      - s1artibartfast 3y ago
        I think you are so blinded by your animosity that you can't parse the quote you provided >If tomorrow laws were changed and the FDA said okay you can do some of this early experimentation in willing human participants that would be a very interesting option I think there would be a lot of people who would step up.” Key parts are (1) if it were legal, (2) if FDA approves, (3) some experimentation You somehow read this as saying they think the FDA is wrong and that they want to do risky and dangerous testing in humans today, which is not at all in the statement. Furthermore, you go on about FDA rules born in blood. This is not at all the reality. The type, quantity, or nature of preclinical testing required by the FDA is incredibly subjective. Sometimes it is needed, sometimes not. the threshold for "good enough" is also incredibly subjective and not some hard line.

by Veserv 3y ago

Dylan16807 3y ago

And once they do enough animal testing, they can figure out a reasonable estimate for the danger. And they've probably done enough for that. The real barrier here is whether it's considered safe enough to let people volunteer, not just whether they can estimate the level of safety. There's a big range of experiments where informed consent is possible but it's not allowed because it's too dangerous. I think this testing is probably in that range. And anything in that range is not a matter of "capital E Evil". Evil is when you're not getting consent, or similar.

Veserv 3y ago
Yes, when they do enough animal testing. That is literally not the case the head neurosurgeon is postulating. Immediately before the quote they say that animal testing is the only available option during early stage. They have no other choice which is why they do it, but if the FDA allowed human experimentation during such early stages it would be a interesting option to pursue in lieu of animal testing. That is literally saying that if they had a procedure that is not ready for humans under existing rules, they would totally do it if the FDA stopped having rules against it.
- Dylan16807 3y ago
  My understanding is that the existing rules require a lot more pre-human testing than is necessary if your only goal is a good estimate of the danger level. Trying to get closer to that amount, and risking more people, might be a bad idea but I would not call it evil.
- s1artibartfast 3y ago
  It seems that you're discounting the possibility that this neurosurgeon thinks that the procedure and technology is sufficiently safe to move to human work in an ethical manner.
  - Veserv 3y ago
    Yeah, well the FDA does not think so and they have a pretty good track record on both safety and expedience when it matters as seen with the expedited COVID vaccine testing. Also, it is not like this is even new technology that requires bespoke safety analysis. There are tons of companies making intracranial implants to support brain computer interaction in human clinical testing and in deployment generally. Here [1] is one in 2016 of a man controlling a robotic arm to shake Obama’s hand with sensory feedback. In contrast, from what I have read Neuralink has used and killed over 10x the average number of animal test subjects and still failed to adequately characterize and reduce the risks to the standard level that literally dozens or hundreds of other researchers achieve routinely. They should ostensibly have 10x the data and experience yet they have failed to achieve even the minimal standard for the easiest step. So forgive me if I trust the FDA and their rules written in blood over the student who wants the test to be easier. [1] https://youtu.be/rqD-I1ehf5E https://youtu.be/rqD-I1ehf5E
    - s1artibartfast 3y ago
      I think you are so blinded by your animosity that you can't parse the quote you provided >If tomorrow laws were changed and the FDA said okay you can do some of this early experimentation in willing human participants that would be a very interesting option I think there would be a lot of people who would step up.” Key parts are (1) if it were legal, (2) if FDA approves, (3) some experimentation You somehow read this as saying they think the FDA is wrong and that they want to do risky and dangerous testing in humans today, which is not at all in the statement. Furthermore, you go on about FDA rules born in blood. This is not at all the reality. The type, quantity, or nature of preclinical testing required by the FDA is incredibly subjective. Sometimes it is needed, sometimes not. the threshold for "good enough" is also incredibly subjective and not some hard line.