Mumbo's current thread ("Record pace of drug approvals") reminded me of a link I had been keeping in my HWPC Possible Threads folder for a while, for posting at what would seem like an appropriate time.
This is probably a good time to post it, as it sort of ties in with what is being discussed in Mumbo's thread.
The "Right To Try" law (signed into law in May 2018) also expedites access to new drugs, but in a very different way.
I'm sure we've all heard the debate before. A patient is diagnosed as terminal with something, and all currently known drugs and therapies have been tried without success, and it looks like the patient will die soon.
Then it is pointed out that there is this other drug, new and very experimental, and so far unapproved, but that some believe may
be able to save the patient, if he is allowed to take it.
The ethical question then becomes: should the unapproved drug be given to the patient, in the hope, or gamble if you will, that it may indeed save the patient's life, or at least improve his situation? Or should it be withheld, on the grounds that, if unsuccessful, it has raised false hope in the patient, and in some cases may have even proved harmful?
The "Right to Try" law says that, with a few restrictions, a patient can now have the legal opportunity to take such medications.
The following article discusses this issue further, adding some background and context:https://www.nbcnews.com/news/us-news/congress-oks-letting-terminal-patients-try-unapproved-drugs-n876606
The phrase "Right to Try" obviously bears a likely intentional resemblance, though some would also say a morbid one, to the phrase “Right to Die,” and it is also likely that both will remain controversial in the eyes of many.
So this "Right to Try" legislation essentially comes down on the side of letting terminal patients try unapproved drugs, on the grounds that they have nothing to lose.
But drugs (or treatments) must have "... passed Phase 1 of the FDA approval process but are not yet on pharmacy shelves." And "... In essence, Right To Try allows doctors to prescribe to terminally ill patients medicines being safely used in clinical trials." (Reference: http://righttotry.org/what-is-right-to-try/
From the first article: "Why do you not want to allow these patients to exercise their right to fight for their future?"
But also: "This will provide fly-by-night physicians and clinics the opportunity to peddle false hope and ineffective drugs to desperate patients."
"The bill ... also provides some legal protections for pharmaceutical makers, doctors or others involved in providing the treatment."
"The biggest hurdle would remain a reluctance by manufacturers to provide unapproved products."
"Critics say the legislation leaves the incorrect impression that the FDA is the bottleneck that deprives dying patients of unproven options ... (but) FDA figures show that it already approves 99 percent of the roughly 1,000 requests it receives from doctors annually for so-called compassionate use of such treatments. The process generally takes about four days, though permission can be granted immediately by phone in emergencies."
But also"... the vast majority of people using unproven medications are using a drug that doesn't work."
Interestingly, one of the groups opposing the legislation was the American Cancer Society Cancer Action Network, saying "... (the legislation) could greatly increase the likelihood of our patients being harmed by unsafe and ineffective experimental therapies."
This controversy is not likely to go away soon, especially now that the government has taken this stand through this legislation. But it's understandable why patients in such a position would want to take such an action, feeling that they have "nothing to lose."