In response to this news from the US Supreme Court, I wrote this:
There are two reasons I’ve heard given for opposing “compassionate use,” one bad, one unfortunate.
The unfortunate one is that even the most apparently iron-clad patient litigation waiver can be turned on its head by a trial lawyer or a politician. So drug firms have a lot more to fear than to gain. One might argue this is a case for litigation reform, which I imagine drug firms and patients would support (but patients’ relatives and lawyers would oppose, and they are more numerous, so don’t hold your breath).
Whatever the rights and wrongs of patient waivers, the fact is, a drug firm would be nuts in the USA, to risk an unproven product being given to a patient whose later-bereaved family could claim acted “in extreme duress.” Note that this argument need not apply in other countries, but US citizens would still be affected when abroad, due to the nasty habit of US courts to adopt global claims of jurisdiction. So the system favors foreign patients and foreign drug firms. The UK, for example, does not appear to need an Abigail’s Law, it’s the treatable patients that are excluded, thanks to the NICE.
The bad reason is that even a TERMINALLY ILL patient should be “protected.” From what? Certain death? Constipation or some other adverse effect?
Yes, there is a risk that patients will, in desperation, agree to try out any quackery. But this is a problem in terminal patients… because… they’re going to die anyway? Surely even a placebo effect is worth a try.
It reminds me of the bizarre regulation that bans prisoners on death row from smoking. Like they’re going to develop lung cancer and escape the lethal injection? Again, so what? It all looks like a puritanical hang-up.
It seems that undermining the authority of the FDA to play God is the real problem. I’ve no doubt that any ruling which allows terminally-ill patients is a thin end of the wedge that leads to the FDA’s pronouncements becoming entirely voluntary. If a terminally-ill patient can try a likely dangerous and unproven Chinese remedy containing lead, or the latest monoclodal antibody, why can’t a patient with a 10% chance of recovery? Or 10.01%? At that point why stop at any sick person? There’s no magic number between 0.01% and 99.99% that can be objectively backed against all other options.
My guess is that the Supreme Court’s justices knew that by taking this case, they were opening the proverbial can of worms, in this case, the potential ruling that the FDA serves no constitutionally-valid function, at least at the federal level, and ducked it.
Personally, I don’t accept the right of any authority to prohibit me from taking any medication that I, in a rational state, am prepared to risk taking. And I’d wager the Supreme Court Justices wouldn’t let such rules get in their way either.
Back street oncology clinics, anyone? It’s called the Internet.