The FDA has faced criticism for delaying access to new medicines that are believed to be beneficial for a variety of ailments, in the name of erring extremely conservatively on the side of safety.
This trend gives rise to a great deal of creativity among doctors who treat folks with chronic, incurable conditions when it comes to writing prescriptions at the fringes of FDA approvals, as well as creating small industries associated with folks heading overseas for treatments or medicines not approved in the U.S., and large demand for many trial programs for new meds and treatments.
(Disclosure: My wife is one of those undergoing an experimental treatment for chronic pain arising from a head injury, which provides significantly better prospects after having been apologized to by doctors for five years over the lack of available, approved treatments.)
So, it was with some interest that I came across this story in the New York Times:
A federal appeals court ruled yesterday that patients with terminal illnesses do not have a constitutional right to use medicines that have not yet won regulatory approval.[...]
The decision preserves the current regulatory system. If it had gone the other way “it would have undermined the entire drug approval process,” said William B. Schultz, a former deputy commissioner of the Food and Drug Administration, who wrote an amicus brief arguing against the early access to drugs.[...]
The group, joined by the Washington Legal Foundation, argued that forcing patients to wait years for a drug to go through the process of clinical trials deprived dying patients of their right to self-defense and violated the Fifth Amendment clause stating that people cannot be deprived of life, liberty or property without due process of law.[...]
Judge Thomas B. Griffith, writing for the majority, said a right to experimental drugs was not deeply rooted in the nation’s history and tradition. Judge Griffith said the right of self-defense “cannot justify creating a constitutional right to assume any level of risk without regard to the scientific and medical judgment expressed through the clinical testing process.”
You know, I can understand and accept the reasoning in rejecting the idea that access to experimental treatment is a constitutional right. I can also understand the FDA’s presumable desire to not create an environment where researchers have an incentive to take advantage of terminal patients as guinea pigs.
However, blocking access to such treatment for folks who otherwise have no hope, seems completely counter-intuitive to me.
The image of an army of hospice workers, chronically ill patients, and their loved ones, going on a clue-by-four-wielding rampage through FDA headquarters just pops into one’s mind, doesn’t it?