> 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).
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.”