Right. They have gone through most of the trials already. That’s key.
You can have a reasonably informed consent if you have some safety data. You can’t really have someone give informed consent about a totally untested drug.
Sure you can. Why not? “I understand this is completely untested and might be poison. My mental competence has been tested and certified by a professional. Being in right mind and having all the pertinent information before me, I still want to inject myself with this. Signed, -Patient”
Something is wrong with your definition of consent if it totally dismisses the patient’s autonomy and right to action.
Our laws don’t really work like that, at least not in the US. Neither criminal nor civil. This might be a shock, but you are generally not allowed to kill people. We have a whole range of laws that make it a crime for you to hurt or kill people.
If you run an unregulated carnival ride and it falls apart and kills everyone, you’re going to prison. The fact that you have everyone sign a waiver that says “I know this might kill me” will not protect you from your own criminal negligence. Nor will it protect you from the lawsuits the families of the deceased will bring.
In your scenario the person giving out untested medication that kills someone would almost certainly be found guilty of criminal negligence if not worse. Based on that same criminal negligence I imagine that the family would be successful in suing.
And yet we have SCUBA dive outfits and mountaineering shops that routinely sell equipment to adventurers, and provide guided services that sometimes do result in deaths. It is not nearly as black and white as you are portraying.
What these all have in common is the notion of informed consent -- I can get PADI certified and then rent SCUBA equipment, and if I then die while cave diving, that is wholly on me not the dive shop operator.
The critical test isn't that safety has been demonstrated, but that potential risks (known or unknown) have been disclosed and understood. I can go out and do risky things, if I want, under those conditions.
And yet I am not allowed to make my own medicine, or to take a completely unproven medicine that might very well kill me, even if I am fully cognizant of the risks involved. The rules regarding medicine and drugs really are different from how we handle other risks in our society.
> The critical test isn't that safety has been demonstrated, but that potential risks (known or unknown) have been disclosed and understood.
Yes and no. For some things it doesn’t matter if the risk is understood. You can drive yourself to a boiling hot spring, put on your scuba gear, and dive in, killing yourself horribly. I cannot take you to the same hot spring, give you scuba gear, and let you jump in. It doesn’t matter if you sign the waivers saying it will probably kill you. The risk is too high and I will still be criminally liable for exposing you to this risk.
In the case of a completely untested medicine, the risk is unknown. It could be the cure for cancer. It could be a placebo. It could melt your skin off. There is no way to even attempt to explain the risk because the danger is unknown. You can’t go in front of a city and argue that the patient knew the risks, because you don’t know the risks.
> And yet I am not allowed to make my own medicine
I’m not sure what that means. I’m pretty sure you can mix up bleach and ammonia in your kitchen and drink it if you want hoping it cures Covid. You can make whatever “medicines” you want so long as they don’t involve controlled substances.
If you mean you can’t pay someone else to manufacture untested medications for you, yeah, probably not. Because that someone else becomes criminally liable for the stupidity they facilitate.
> I am saying it shouldn't be that way.
I’m not sure the current rules are that bad. I’d take this over scammers being legally able to sell poison as medicine so long as they can get the buyers to sign a document saying they know it’s poison. “The FDA makes me get you to sign this. Wink wink.”
> You can make whatever “medicines” you want so long as they don’t involve controlled substances.
In the USA at least, it is against federal law to manufacture any pharmaceutical without license, irregardless of whether it is a controlled substance or ever sold.
I don’t know the actual laws about pharmaceuticals. This seems 100% at odds with the claim you made just below that making your own vaccine would have been legal, though.
Regardless, this is really a separate question from whether you should be able to legally permit others to be criminally negligent towards you.
Vaccines of the type mentioned in the other comment are not pharmaceuticals. They do not have a method of direct interference in the biochemistry of the body. The nasal vaccine would have been totally inert, and neither injected nor ingested, so it rather uniquely fell outside of regulator authority, so long as we weren't going to sell or advertise it. Oversimplified, it would have basically involved snorting inactivated spike proteins.
But anything that is ingested (food) or has biochemical interactions (drugs) are regulated and illegal to produce outside of license. Only in the case of small-scale food stuffs are there safe harbor exemptions (e.g. for mom-and-pop bakeries).
At the start of the covid epidemic in 2020, I had access to a lab and the know-how to make a nasal vaccine. I, and a few friends, tried to do this. We would only have made it for ourselves, and no one else, and shared the results with researchers. The lab -- which was just renting us equipment and bench space, not involved at all -- backed out when they were threatened by the FDA to lose government contracts for processing PCR test kits. What we were doing was not illegal, as clearly indicated by the regulators using other means available to them to shut it down.
I have family members suffering from Alzheimer's, with a probably genetic pre-disposition. Getting consent from someone who is already pretty far gone is questionable, but some who have not yet shown symptoms have expressed interest in signing pre-authorized directives in advance to permit these kinds of risky experimentation once they are clearly at the end of their good years. That is not legally possible under the FDA authorization laws & current regulations.
You can have a reasonably informed consent if you have some safety data. You can’t really have someone give informed consent about a totally untested drug.