Do You Know Who Frances Kelsey Is? I didn’t

I came across this article in the excellent Pharmalot site on Frances Kelsey by Ed Silverman

He’s right, ‘The odds are that you don’t.’

Fifty years ago Frances Kelsey transformed the way prescription drugs are regulated. As a new FDA employee she was assigned to review Kevadaon, better known as its brand name drug thalidomide.

Kelsey at the time questioned the drugs safety. “It just came with so many extravagant claims that I didn’t believe.” Sounds familiar to me.

Kelsey’s work led to the amendment of the Food, Drug & Cosmetic Act, requiring safety and effectiveness testing and informed consent in clinical trials. At this time the drug company Merrell were giving thalidomide to more than 1,000 US docs to distribute to 20,000 patients as part of a ‘so-called’ investigational trial. Some trial; many patients were not informed they were actually participating in a study.

They say the good die young. I think it’s more like the good don’t retire young: Kelsey retired from the FDA in 2005 at age 90.

There is more on the story at the New York Times