We have a problem where approved = mandatory for Medicare to cover, so that even if you are willing to independently pay for whatever special medication or trea

We have a problem where approved = mandatory for Medicare to cover, so that even if you are willing to independently pay for whatever special medication or treatment you want to take a chance on, letting you do it would mean (because of poorly-thought-through regulations) buying one for everyone with the same condition whether it turned out to work for you or not. There's an enormous incentive for regulators to act as doctors, deciding what to prescribe, rather than as safety testers keeping obvious poisons out.