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