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.
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.