Prohibited medical treatments and procedures in the US

[Ferret_Herder]

@CalMeacham

But I think the OP was more concerned about cases not involving pregnant women, where only one life is in the balance. If you’re suffering from an incurable, fatal disease, you have to wonder who is being “protected” if you make an informed chioice to try this drug or procedure, yet it’s banned.

There’s a difference, I should note, between something actually being actively banned and it being not yet tested/not yet approved. The former indicates that the drug had no effect or actually had harm, after being tested.

As a related case, what about things like tyhe case in Lorenzo’s Oil, where the boy lacks the ability to assimilate necessary chemicals from food? I realize that the film is not a documentary, and things may be very slanted, but they give the impression that it was virtually certain that he could look forward to a future of severely diminished capacity. Once again, who is served by denying him this experimental oil? (assuming the film was pretty straight about it) If he and his parents knew what they were getting into, why is it a Bad Thing for them to take the chance of amelioration against a virtual certainty of a degraded quality of life?

I haven’t seen the film, but according to Wikipedia article, it has onlyeffectiveness in only certain cases - when symptoms haven’t yet developed - thus far, and active testing is underway. (Another link in the article notes that Lorenzo wasn’t getting better and many children taking the oil died, contrary to the rosy ending of the movie.)

I am a voting member on a human subjects protection committee at the medical center I work at. There are exceptions for drugs/devices that are experimental to allow them to be used on patients who are not involved in research studies. IIRC (it’s been a while so my memory is fuzzy on the details) I believe one of the cases that came before our committee involved a drug not yet approved in the US. The parents of the child involved obtained the medication legally out of the country, but due to its nature (IV infusion, perhaps?) it had to be administered by a physician. The hospital’s physician who was involved was letting us know he was doing this, and we acknowledged it. (This is a very simplified look at the process, mind you, and only from our viewpoint. I don’t know what the physician had to go through to get to that point.)

Part of the problem with the “just hand out the experimental drugs” impulse is that even people with almost assuredly fatal illnesses also deserve protection against unnecessary harm. In fact, those people are among the most vulnerable to manipulation, due to their desperation. I do know that medical necessity is taken into consideration when new studies are being reviewed, though - if the drug is for something more mundane, there is less of a tolerance for risk than if the condition is something that is almost assuredly fatal and/or if there are no decent alternative therapies. Patients must still be fully informed of what they’re getting into, however.

On a side note: if I understand correctly, thalidomide is currently used in the US for prevention of a disease associated with leprosy, as well as being used “off-label” (i.e., not FDA-approved for, but is regardless prescribed by doctors) for multiple myeloma and for esophageal ulcers associated with HIV.

[Otto]

The drug I was thinking of was AL-721. Amazing what one can dredge out of the memory banks twenty years later. I may be thinking of some other drug with the caravans but I definitely remember the “trade your favorite AL-721 recipes” fad.