The regulation is to ensure a working marketplace - which is fundamentally a collection of humans interacting.
The regulation is to prevent predictable abuses of market power.
Because I'd happily do it. I've watched multiple family members suffer from some form of severe mental decline and it is horrifying enough to make me willing to sacrifice myself if there is even a sliver of a chance that my sacrifice will help future generations avoid that pain. And since we're all nerds here, we all know that if we want to know if a thing actually works the way we want it to, we have to test it repeatedly in its working environment.
Not really, no. A company that unleashed unproven drugs in a vulnerable human population would be sued into oblivion. They would lose in court over and over as judges and juries decided that no, you cannot in fact sign away your right to not be subjected to criminal negligence. They would very likely be subjected to criminal prosecution as well.
This (the lawsuits) happens all the time. People sign waivers, get hurt, and the courts decide that the level of negligence involved overrides the waiver. Happened a while back at a Jiu Jitsu gym. Someone signed all the waivers and got paralyzed and successfully sued for $46 million. The jury decided that the instructor was criminally negligent.
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.
Something is wrong with your definition of consent if it totally dismisses the patient’s autonomy and right to action.
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.
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.
I am saying it shouldn't be that way.
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.”
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.
Regardless, this is really a separate question from whether you should be able to legally permit others to be criminally negligent towards you.
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).
If you read that statement anywhere other than this thread, it would be part of a cautionary tale.
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.
We put locks on doors not because we wish to inconvenience good people. We put locks on doors to dissuade malicious people.
I do not remember the cautionary tales that resulted in these laws. I do know that these cases do exist.