The Right To Try law: follow up to Mumbo's record pace thread

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."

Dr. David Gorski is an American surgical oncologist, professor of surgery at Wayne State University School of Medicine, and a surgical oncologist at the Barbara Ann Karmanos Cancer Institute, specializing in breast cancer surgery). Here are some of his thoughts on Right to Try:

"As I’ve discussed many times before, the basic idea behind 'right-to-try' is that the FDA is killing people (or letting people die) through its bureaucratic delays in approving drugs, lives that, if you believe right-to-try advocates, could be saved by cutting the FDA out of the decision between drug companies with experimental therapeutics and terminally ill patients who want to try them. It’s nonsense, of course. In actuality, the FDA is not unduly slow approving new drugs, in particular as compared to Europe, and, more importantly, there is an expanded access program that approves >99% of requests. True, the paperwork to access drugs through expanded access programs was once onerous, but the FDA has made great strides towards reducing that burden. Oddly enough, right-to-try advocates often mischaracterize an expanded access program in France as being a success story of right-to-try when it is not. (They also like to conflate cases of compassionate use or fast-track approval with right-to-try.) In other words, Trump’s speech is a total distortion of the true situation, as has been the case with so much that 'right-to-try' proponents have said over the years that they have been promoting this law and the 40 or so state-level laws before it. As I have also discussed so many times before in the context of right-to-try going back to 2014, right-to-try provides no new right and no new access to experimental therapeutics that weren’t available before through FDA expanded/compassionate use programs. What it does do is to strip away important patient protections, leaving the most vulnerable, terminally ill patients, in essence on their own. It’s a bait and switch, the bait being the promise to help terminally ill patients, the switch being a major step in the process of dismantling the FDA."

https://respectfulinsolence.com/2018/06/01/right-to-try-bait-switch-that-will-not-help-terminally-ill-patients/