Kaiser Health News, March 6, 2017
Carrie Feibel, KQED


Read the Full Article

[...] “We know some people try to take advantage of our desperation when we’re ill,” said Dr. R. Adams Dudley, director of the Center for Healthcare Value at University of California, San Francisco. “If we take the FDA out of it, how do we protect people from physicians or drug companies that will want to sell them things and will want to prey on their desperation?”

Dudley said the FDA and the clinical trial process were put in place for a reason — not just to shut out would-be snake oil salesmen, but to ensure that manufacturers are producing a safe product and not cutting corners.

“If you say there’s a path that’s not through the FDA,” he said, “then there are billions of dollars out there to be made by skipping the important steps that we’ve developed.”

The new state laws are called “right to try,” Dudley said, but all that patients can really do is ask for an experimental medicine. Drug companies don’t have to give them the medicine, and insurance companies don’t have to pay for it.

Dudley said patients could spend huge amounts of money trying a drug that hasn’t been proven to work. And the patient may also be giving up their hopes for a controlled, peaceful death at home.

“Instead, you try a drug and you get very severe lung problems,” he said, “and you end up on a breathing machine in a hospital. That could cost hundreds of thousands of dollars.” [...]

bioethics clinical research end-of-life fda health care finance health law policy human subjects research insurance market pharmaceuticals public health regulation