You’re not seeing all the other candidate treatments that made things worse. If it just gives everyone a heart attack immediately the question would be, why didn’t you try this out on mice first?
My body, my choice. I get the restriction on marketing and selling until some degree of safety and perhaps efficacy is demonstrated. But I should be allowed to choose to take the treatment if offered for free, even without any previous study.
That's fair, I guess, but say there were some way for me to sign a contract saying they could test on me should I become afflicted Alzheimer's? Wouldn't there be some sort of legal protection for them, then?
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.
> Wouldn't there be some sort of legal protection for them, then?
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.
Things like these are sometimes done for experimental cancer therapies. Granted, the patients are going to die anyway, and the therapy has gone through most of the trials.
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. The restriction is on anyone else offering it to you. Theres a long tradition of medical researchers experimenting on themselves. Barry Marshall was so sure bacteria could cause ulcers that he consumed said bacteria, and gave himself ulcers in order to cure them with antibiotics.
There’s also a FDA provision for treatment of last resort. If you’ve got a terminal condition with no approved treatment and there’s a possible treatment of unknown safety and effectiveness you can apply and get that treatment.
If you or a loved one has Alzheimer’s I highly encourage you to request this treatment. You’ll be risking unknown side effects and or death, but it will generate data for those who come after and could advance the treatment of this terrible disease by a decade.
The main reason for all of this, is scams. Nutjobs without any medical background making claims without any scientific evidence.
Or scam artists putting sawdust from a "special tree" into a bottle, and saying it cured his aunt, so it will cure you! If you look at the history of such things, it's just a constant battle against people being fleeced out of money.
Con artists (and some of these wear lab coats and are quite professional in appearance and speak) know that desperation means easy prey. It's disgusting, but there it is.
And it wasn't just a little problem. It was a huge problem. If the legal framework we have in place was torn down, you'd see all that re-emerge in a second.
I agree that there should indeed be a way to balance snail oil salesman techniques, with the choice of someone in a dire circumstance. I did once read that there are FDA approved methods to get in on early stage/pre-clinical trials. These are targeted for people with severe conditions. People aren't being heartless here.
But at the same time, loved ones will litigate to get money back from scam artists. This also includes going after doctors or facilities or anyone willing to enable such actions. And if treatments go sideways, and no one validated that it was anything more than made up gibberish? The lawsuits will fly then, too. The cops may follow.
And it should be this way
Truth is, you are free to imbibe and consume anything you want. No one can really stop you. And whatever method is being used here, I'm sure you could replicate it, buy the hardware, and so on. You are free to do this.
And no, I am not allowed to imbibe and consume anything I want (see war on drugs), nor is someone allowed to make a drug for me, even if they give it to me for free.
I am not free to just make a medication on my own. I tried this. The lab I was going to rent backed out when the FDA threatened shutting them down.
