Good question. I have narcolepsy. There is a medication called TAK-861 which is the first drug to actually treat the root cause of the disease. It has passed phase 1 and 2 trials proving it is safe and effective. My doctor is involved in the research has said he wishes he could prescribe it to me now, but it is still in phase 3 trials and will not be approved by the FDA for another 2 years, so he can't give it to me.

I despise nothing more than these bureaucrats. If I want to take the risk on a new medication then that's my choice. If someone else doesn't then that's fine too. I'm not the one telling other people what to do, these worthless busybody bureaucrats are.

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os2warpman a day ago | parent | next [-]

>will not be approved by the FDA for another 2 years, so he can't give it to me.

edit: I wrote a bunch of bullshit and then deleted it but the points are:

1. Narcolepsy sucks

2. The FDA can't stop your doctor from giving you TAK-861, the likely culprit is Takeda. It is 100% legal for Takeda to sell Oveporexton so long as they don't claim that it treats narcolepsy until it has been approved, and it is 100% legal for your doctor to give it to you.

3. Have you looked at >>>RIGHT TO TRY<<<? Again, with this the ball's in Takeda's court.

https://www.fda.gov/patients/learn-about-expanded-access-and...

I know nobody believes me.

Here's an ambulance chaser's blog:

>Unapproved drugs exist in a gray area in U.S. law. Although it is not illegal to prescribe non-FDA approved drugs, it is also not viewed as best practice. If a doctor prescribes an unapproved drug, he or she could face civil liability for the patient’s injuries, illnesses, side effects or death upon taking the drug if the physician reasonably should have known of the potential health risks due to the lack of FDA approval.

https://www.liljegrenlaw.com/can-my-doctor-prescribe-non-fda...

	▲	terminalshort a day ago \| parent [-]
		It may not be the FDA that is directly responsible here, but if the FDA approved it tomorrow, all my problems will go away. That's because, as you mentioned, our system relies on bureaucratic stamps of approval to adjudicate responsibility rather than anything real. Doctors who prescribed oxycontin and harmed their patients get off scot free because they can just say "but I was told it wasn't addictive" because it has this stamp of approval. I will certainly take a look at those links as they may help me, but this doesn't change my opinion on the state of things. It infuriates me that I have to jump through all these bureaucratic hoops to get what I need. There is a company with a product they want to sell, and a customer who wants to buy it. The fact that they won't just sell it to me is an indication that our system is fundamentally broken. I put little weight on the fact that the FDA in particular isn't outright banning me access. They are just one arm of the bureaucratic squid that is strangling me. The FDA says "take this at your own risk" which is on the face of it a fair statement. But they know that the civil liability system, which is just the other arm of the squid, will deny me the ability to actually take my own risk. And they know that the arm of the squid that mandates Takeda can't sell me the medicine without the approval of a doctor means that I won't be able to get through that bureaucratic gatekeeper. So the whole system works together against me while ensuring that no part of it can be blamed because it isn't the decision of any one part that prevents me from getting it, but rather the interaction between these parts. This is why "burn it all down" is such a popular position.

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curt15 a day ago | parent | prev [-]

>I despise nothing more than these bureaucrats. If I want to take the risk on a new medication then that's my choice.

Are there laws that would indemnify the healthcare provider for unexpected adverse outcomes for voluntary recipients of experimental drugs?

	▲	terminalshort a day ago \| parent [-]
		I don't know. I doubt it. This points to a fundamental problem in our liability system that there is no simple "This is my choice and there is nobody to blame but me. I take all the risk and can't sue anybody" contract. Our laws are written by lawyers for lawyers.