Frances Oldham Kelsey died yesterday, age 101. Kelsey is responsible for barring thalidomide from being sold in the US. In the late 1950s, thalidomide was widely marketed in Europe to treat insomnia and nausea in pregnant women. The manufacturer, Merrell, wanted FDA approval to market the drug in the US as well. Kelsey was not convinced that the drug was safe; she dug in her heels and resisted pressure from Merrell and her own colleagues.
Kelsey had been at her FDA post less than a year when the application crossed her desk; she was a junior employee and one of the few women scientists at FDA. She held her ground against enormous pressure, until evidence from Europe and Canada began to accumulate, showing that the drug caused phocomelia, literally meaning “seal-like” limbs, in children whose mothers had taken the drug, as well as many other health difficulties. Tens of thousands of children were affected in Europe, and many more in Canada. In the US, thanks to Frances Kelsey’s determination, backbone, and scientific acumen, the FDA counts only 17 children affected.