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Comment by Veserv | Hacker News Reader

In the interview you mention [1] at 1:27:20 “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.”

Holy shit that is a terrifying opinion for the head neurosurgeon at Neuralink to have. He thinks it is morally acceptable to experiment on humans with untested medical procedures that have demonstrably killed at least dozens of animal subjects and using processes that have resulted in inserting the wrong fucking implants in animal subjects. That is not merely immoral, that is capital E Evil.

If that is the sort of person they keep as the head of neurosurgery then I too will take his word for it and say they should be shut down and entire leadership team banned from management in any medical research as they have no business designing processes that may impact the lives of humans or other creatures when they have such a callous disregard for those same lives.

https://youtu.be/3ZGItIAUQmI

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Experimenting on animals that cannot give informed consent is ok but not when there's a human involved? Arguably, I don't think that humans should get paid for what is essentially an elective surgery experiment when there's a real possibility of death. It should be completely volunteered and compensation should come in the form of a hospital bed, meals, and post-op care.

Jesus.

So the researchers "benefiting" should keep the volunteers alive, but actual compensation for time and suffering is somehow dismissable?

I think the people who say animals are sentient beings deserving of respect are less horrible

The same thing happens with organ donations. And sex work, sometimes.

As a society, there are things we don't want people to be coerced into via need for money. Trying hard enough to avoid that coercion gets in the way of fair compensation for those things.

If you can solve that problem (and not by just saying "universal basic income" very loudly) they'll probably give you the Nobel for economics.

Letting people volunteer for something dangerous is capital E Evil?

No it's the human experimentation part that's evil not "letting people volunteer."

Also the fact that it is structurally almost impossible for a layperson to give informed consent on a dangerous, highly experimental, early stage medical procedure, let alone a elective, non-medically necessary procedure. We have rules about human clinical testing for literally that reason.

Why can't they give informed consent? A layperson can understand a percent chance of grievous injury or death.

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.

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.

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.

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.

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.

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

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.

“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.

> 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.

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

> 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.

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.

>They are using the current state of the law as their definition for what is unethical

No, they're not. See here: https://news.ycombinator.com/item?id=35837498

>It isn't a hard line, but negotiated with the FDA on a Case by case basis.

Of course it's not a hard line, but this particular case falls way over on the 'not allowed' side. It's not any kind of borderline case.

>>They are using the current state of the law as their definition for what is unethical

>No, they're not. See here: https://news.ycombinator.com/item?id=35837498

They are making arbitrary assumptions for what is a procedure is, when it is in fact open ended, calling it "dangerous, highly experimental, early stage medical procedure"

They are assuming that the same procedure done in monkeys would be done in humans, which is not supported by the quote, or how the real world works.

You can different experiments in humans than monkeys to achieve the same goal, they need not be identical, or even similar.

They didn't give an argument for the status quo, they gave an open-ended argument based on danger being bad. But the correct tolerance for danger is not zero, so proving something is dangerous is not enough.

For a car comparison, it's easy to argue that going faster is less safe, but that's not enough to explain why a speed limit for a road is specifically 35mph, and doesn't tell you if 35mph is correct for that road. Maybe it should be 25mph or 45mph.

The rest of their argument is making a bunch of assumptions with no evidence shown. They're assuming that the current line is exactly enough to determine the level of danger to the point that you can get informed consent. They're assuming that the current line is an exact match to what's ethical.

But maybe that's not true. Maybe the FDA is 50% too lenient. Or maybe they're 50% not lenient enough. This commenter is failing to make a case for the current regulations being just right. They're making a strawman about changing the regulations a huge amount, jumping all the way to nearly unchecked experimentation. Of course that's bad, but that's not what the neurosurgeon actually said.

>This commenter is failing to make a case for the current regulations being just right.

I don't think they're trying to make a case for the current regulations being just right. The point here is very simple:

1) X is unethical.

2) This guy said they'd do X if it wasn't against FDA regulations.

The key point about X is that it's unethical. Whether or not FDA regulations are perfectly calibrated is beside the point.

The problem is that they're making the claim that X is unethical with zero information on what X is. In this case X is undefined and could be anything that is not currently permitted.

If you claim that X is always unethical, and the only fixed characteristic of x is that it's not currently permitted, then there are only two solutions:

(1) You think that the current rules are a perfect match for ethics OR (2) anything that violates a rule is unethical.

> I don't think they're trying to make a case for the current regulations being just right.

That's sure what it looks like to me when they say "Wanting to do early experimentation, that is currently only allowed to occur on animals due to safety concerns, on humans is definitionally unethical and especially dangerous. We banned it because it is unethical and especially dangerous in basically every case."

"definitionally unethical" based on what is currently allowed. So FDA regulations are a cornerstone of that particular argument.

And as I elaborated upon in my previous comment, their only other argument is a one-sided "that increases danger" argument that isn't enough because it also applies to things that are ethical.

I’m confused. The part of their comment you quote isn’t making a case for the current regulations being just right. It’s not even saying that, let alone trying to make a case for it.

If wanting to do something the regulations disallow is definitionally unethical, banned because it was unethical, then either the regulations are exactly correct wrt ethics or they are actually too permissive.

Right? How else can I interpret that?

And can you quote any argument they've made for the experiments being unethical that doesn't either:

A) base the argument on current FDA rules

B) assume some kind of extreme example like "so experimental we can't even explain the danger well enough for informed consent to be possible"

I would be interested in a discussion of specific issues with specific possible experiments but I don't see that happening anywhere. Just someone taking the neurosurgeon's words and interpreting them in the most extreme way possible.

>If wanting to do something the regulations disallow is definitionally unethical...

Here's what they actually said:

"Wanting to do early experimentation, that is currently only allowed to occur on animals due to safety concerns, on humans is definitionally unethical..."

I don't know why, but you are just persistently misreading or misinterpreting the OP's comments.

If you actually read the rest of the OP's comments, it's completely obvious that they don't think that the current regulations define what's ethical. They very explicitly say that what's ethical and what's in accord with the regulations are two separate things, and even give a hypothetical example to illustrate this.

The only definition for "early" they're giving is the line that is currently set by FDA regulation! They're treating it all exactly the same, as long as it's currently not allowed.

They have not given any other information on where to draw the line.

> even give a hypothetical example to illustrate this

No they didn't. They gave an analogy about how murder is bad. Which is no more helpful than "the most extreme possible interpretation of what the neurosurgeon said would be bad". They haven't given any examples of experiments that are okay or not okay.

All they've said is that a super extreme early experiment is bad, and then acted like the neurosurgeon said they wanted to do that. They are either ignoring the possibility of less extreme examples, or acting like everything the FDA doesn't allow is exactly the same.

I can't tell you which it is, so if you insist it's not the latter then it must be the former. That's just as bad. It's a strawman.

If they gave a non-strawman non-FDA explanation of where to draw the line, then I must be blind, so please quote it.

The point of the hypothetical example was just to illustrate that whether or not something is ethical is a separate question from whether or not something is in line with the regulations (or the law, in the analogy). This is why it’s so odd that you seem to think the OP was saying that the current regulations define what’s ethical.

> All they've said is that a super extreme early experiment is bad

Correct. Or any early experiment on humans (‘extreme’ or not), as the potential benefits don’t justify the risks.

> and then acted like the neurosurgeon said they wanted to do that.

Yes - that’s the impression I get from what the neurosurgeon said.

I don’t understand why you are asking me or OP where to draw the line. You don’t have to know exactly where to draw the line in order to know that certain things are on one or other side of it.

> Or any early experiment on humans (‘extreme’ or not), as the potential benefits don’t justify the risks.

Well that's just it. If 'early' is automatically bad, and 'early' just means anything not currently allowed, then you're using the FDA's definition.

Or when you use the term 'early', are you defining 'early' based on what is ethical? That's definitely not the meaning of 'early' the neurosurgeon was using!!

The neurosurgeon wants to do 'early'. But 'early' is a vast swath of scenarios, covering orders of magnitude of safety and preparedness. Which is why I think using very extreme examples does more harm than good to having a conversation about this.

I don't think letting people sign up to do a test moderately earlier than they currently can is a huge ethical problem. Even if we assume it's a bad idea, it's not Evil. That's my real objection to the original point. A medium-size change to current regulations is nowhere near "capital E Evil".

I don't think we need to have exact discussions about where the line is, my point is that the great-whatever parent was assuming some kind of crazy extreme and acting like that was the only possible meaning for the sentence. And my asking them where the line is was a way of trying to make that clear, that they're neglecting more mundane scenarios.

>and 'early' just means anything not currently allowed,

Well no, it doesn't mean this. It means testing a treatment that's still highly experimental and a long way from being approved. In other words, a treatment that is in the EARLY stages of its development (in the normal English sense of the term). Listening again to the relevant portion of the interview, I think the claim that the interviewee was using 'early' to mean 'whatever the FDA regards as early' is pretty clearly false. They say 'we can't do early stage testing on humans because the FDA bans it', but that obviously doesn't mean that they define the meaning of 'early' by FDA regulations. That would be as erroneous as saying "the law bans murder, therefore the meaning of 'murder' is defined by the law".

>Or when you use the term 'early', are you defining 'early' based on what is ethical?

No - of course I'm not. How do you come up with these bizarre misreadings?

> It means testing a treatment that's still highly experimental and a long way from being approved.

If that's the definition, then that doesn't sound evil to me. It doesn't sound like informed consent is impossible.

Also I feel like that definition includes lots of existing allowed clinical trials.

> That would be as erroneous as saying "the law bans murder, therefore the meaning of 'murder' is defined by the law".

What's the thing similar to murder that is allowed? The equivalent of "FDA approved middle-stage testing"? Otherwise this analogy falls apart half-constructed.

> No - of course I'm not. How do you come up with these bizarre misreadings?

Well the word murder does work that way. Something being murder often depends on whether it's ethical or not. If it's ethical self defense then it's not murder, for example.

So you don't need to get upset that I asked just in case.

>If that's the definition, then that doesn't sound evil to me. It doesn't sound like informed consent is impossible.

It's impossible because the risks are largely unknown, so there's nothing much to be informed about. Anyone who wants to take on such unknown and potentially enormous risks is probably acting irrationallty, and it's unethical to exploit such people.

But this is where we get to the "written in blood part". The history of medicine is full of cases of people being horribly exploited in early stage testing. That's why we have the rules. Not because of abstract arguments about informed consent, but because we've seen what happens if we don't. It's all very well to imagine people giving informed consent to this sort of testing and imagine scientists acting responsibly and ethically in this sort of scenario; but we know that this isn't actually what happens.

>What's the thing similar to murder that is allowed? The equivalent of "FDA approved middle-stage testing"? Otherwise this analogy falls apart half-constructed.

The point of the analogy is simply to show that "the rules ban X" doesn't entail "the meaning of 'X' is defined by the rules". So e.g. if someone says "I don't fish in this lake because the rules ban it", that doesn't mean that they take the verb 'fish' to be defined by the rules in question. The same goes for FDA rules and 'early stage testing on humans'.

"Early" just seems like an extremely relative term to me, which is why I ask for examples. I guess not to you in this context. I don't think we're going to resolve this.

As someone who literally would have never existed albeit for human experimentation, I have something of an opinion that sometimes pushing the boundaries of science is worth ethical sausage making.

Doing the experiment is a fundamental part of letting people volunteer for the experiment.

And it's not cruel on purpose, it's dangerous because the tools are limited.

You are putting words in his mouth and then getting upset about them.

His quoted words are him frankly admitting to wanting and being willing to do the sort of human experimentation universally prohibited by medical ethics. He is saying he's only being stopped by the oversight mechanisms that are in place to stop exactly that.

I do find that frightening and don't see what you and other commenters gain from downplaying the seriousness of that intention.

there are many countries where assisted suicide is becoming more widely accepted. Many people are willing organ donors and blood donors. Everyone and their bodies absolutely must be treated with the utmost respect, but for many, the highest respect is to be part of even the smallest iota of scientific progress.

Y'all are fucking scary I'm just extremely thankful we actually have rules of medical ethics that are enforced rather than letting you and this wannabe Mengele run wild.

That's where I think you were putting words in his mouth. I don't think they are saying that they would want to do anything unethical or especially dangerous. That's connotation that you are inserting

Wanting to do early experimentation, that is currently only allowed to occur on animals due to safety concerns, on humans is definitionally unethical and especially dangerous. We banned it because it is unethical and especially dangerous in basically every case. There are literal decades of experience and piles of bodies supporting that point.

Obviously there are some exceptions, but whatever Neuralink is doing is not one of them. Their technology and any benefits it might bring is at best wholly speculative and would require years to reduce to practice. There is exactly zero compelling reason why they should be given a pass on human testing safety.

Suggesting that it would be acceptable to replace their animal testing with human testing as long as the volunteers were willing is about as “open and shut” unethical as you can get.

Human-based experimentation without proper research and understanding is unethical. We've seen what happens when that's done multiple times throughout history. That's why we have these guidelines in place. It's unethical, and what he would want to do without the law in place is unethical.

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