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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 vac

by 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.
- Veserv 3y ago
  “We do animal research because we have to. There is no other way around it. 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.” There I added some context. He said they do animal testing because they have no other choice as the FDA has said such testing is illegal on humans. If, however, the laws were changed and it were no longer illegal then they would be excited to do it on willing humans. The law changing does not affect the morality of the underlying act. The underlying act is immoral, that is why it is currently banned. Saying you would do it, without any concern for the underlying morality, just because they unban it is textbook unethical. I mean seriously, if somebody said: “If tomorrow laws were changed and the government said okay you can murder people who deserve it that would be a very interesting option.” would you also think this person is a fine morally upstanding person because they said (1) if it were legal, (2) if the government approves, (3) people who deserve it. No, because that would be a comically stupid argument as it is obvious to any observer that their moral compass is being guided purely by what it legal and not by what is ethical and they would totally murder people if it was allowed.
  - Dylan16807 3y ago
    > The underlying act is immoral, that is why it is currently banned. This regulation draws a line in a very wide territory, and you have a lot more faith that it hits just the right spot than I do. > their moral compass is being guided purely by what it legal Are you sure you're not letting your moral compass be guided by what is legal? Like, if you came at this from purely moral grounds, with no knowledge of the law or past cases, would you make the same decisions as the FDA? No deviations? But more to the point, your hypothetical bad person is guided "purely" by the law, but you haven't given evidence that this actual neurosurgeon is guided "purely" by the law. He said he wants to do "some" experiments that aren't allowed. That doesn't mean he wants to go hog-wild.
  - s1artibartfast 3y ago
    you are still entirely making up an assumption for what the human testing is and then deciding it is grossly unethical. >The law changing does not affect the morality of the underlying act. The underlying act is immoral, that is why it is currently banned. You say it isn't about the law or FDA but ethics. OK, then the ethics depend on the specific act you are performing and it's risk, not the government rules. You cant have it both ways. You can't claim that anything that differs from current law makes it inherently unethical
    - foldr 3y ago
      > You can't claim that anything that differs from current law makes it inherently unethical The person you're responding to didn't claim this, and explained in detail why early-stage testing on humans is unethical without reference to current law.
      - s1artibartfast 3y ago
        They are using the current state of the law as their definition for what is unethical, not any attribute or characteristic of the act itself. This is circular. It does nothing to explain what is ethical or not. Have someone who's worked in preclinical testing and clinical trials, my impression is also that they don't have firm understanding of what the current status even is. It isn't a hard line, but negotiated with the FDA on a Case by case basis.

by Veserv 3y ago

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.

Veserv 3y ago
“We do animal research because we have to. There is no other way around it. 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.” There I added some context. He said they do animal testing because they have no other choice as the FDA has said such testing is illegal on humans. If, however, the laws were changed and it were no longer illegal then they would be excited to do it on willing humans. The law changing does not affect the morality of the underlying act. The underlying act is immoral, that is why it is currently banned. Saying you would do it, without any concern for the underlying morality, just because they unban it is textbook unethical. I mean seriously, if somebody said: “If tomorrow laws were changed and the government said okay you can murder people who deserve it that would be a very interesting option.” would you also think this person is a fine morally upstanding person because they said (1) if it were legal, (2) if the government approves, (3) people who deserve it. No, because that would be a comically stupid argument as it is obvious to any observer that their moral compass is being guided purely by what it legal and not by what is ethical and they would totally murder people if it was allowed.
- Dylan16807 3y ago
  > The underlying act is immoral, that is why it is currently banned. This regulation draws a line in a very wide territory, and you have a lot more faith that it hits just the right spot than I do. > their moral compass is being guided purely by what it legal Are you sure you're not letting your moral compass be guided by what is legal? Like, if you came at this from purely moral grounds, with no knowledge of the law or past cases, would you make the same decisions as the FDA? No deviations? But more to the point, your hypothetical bad person is guided "purely" by the law, but you haven't given evidence that this actual neurosurgeon is guided "purely" by the law. He said he wants to do "some" experiments that aren't allowed. That doesn't mean he wants to go hog-wild.
- s1artibartfast 3y ago
  you are still entirely making up an assumption for what the human testing is and then deciding it is grossly unethical. >The law changing does not affect the morality of the underlying act. The underlying act is immoral, that is why it is currently banned. You say it isn't about the law or FDA but ethics. OK, then the ethics depend on the specific act you are performing and it's risk, not the government rules. You cant have it both ways. You can't claim that anything that differs from current law makes it inherently unethical
  - foldr 3y ago
    > You can't claim that anything that differs from current law makes it inherently unethical The person you're responding to didn't claim this, and explained in detail why early-stage testing on humans is unethical without reference to current law.
    - s1artibartfast 3y ago
      They are using the current state of the law as their definition for what is unethical, not any attribute or characteristic of the act itself. This is circular. It does nothing to explain what is ethical or not. Have someone who's worked in preclinical testing and clinical trials, my impression is also that they don't have firm understanding of what the current status even is. It isn't a hard line, but negotiated with the FDA on a Case by case basis.