Experimental Medicine Access: Are We Too Careful for Our Own Good?

Without access to risky, experimental drugs that couldn't be acquired in today's overly safe regulatory climate, Sigrid Fry-Revere's son probably would have died in infancy from cancer.

Fry-Revere, a Cato Institute bioethicist, mentions that in an editorial rebuke of a federal court's refusal to force the FDA to allow desperately ill people to take unapproved therapies.

According to the FDA, such treatments would lead to unacceptable risk.

Unacceptable to whom?

In denying patients the right to weigh the risks for themselves, the
FDA and the court denied them their only hope for survival. The government essentially told them it would be better for them to do nothing and die than to take risky experimental treatments.

I wrote about this decision last month, and I agree with Fry-Revere. However, one criticism: she uses the case of Jolee Mohr to frame her arguments. "The proper response to tragedies like the one that befell Jolee Mohr," she writes,
"is not to try to make experiments risk-free but to help patients understand the risks."

But Mohr was suffering from moderate rheumatoid arthritis, not cancer, and existing drugs were successful in controlling her disease. It's
possible to argue that highly risky treatments shouldn't tested -- that individuals shouldn't be permitted to weigh the risks -- in such cases, where the need is not pressing.

Sigrid Fry-Revere: At times, an 'unacceptable risk' may be a patient's best bet [Dallas Morning News]