thalidomide
oracknows | August 9, 2015I learned over the weekend that a historic figure in science-based medicine has died. If you know anything about the history of the Food and Drug Administration (FDA), you will know this woman's name, Frances O. Kelsey, MD, PhD. It turns out that Dr. Kelsey died on Friday at the age of 101. Somehow I missed the news on Friday, but once the story showed up in my news feeds over the weekend, I knew I had to make her today's topic. Here's the short version:
The sedative was Kevadon, and the application to market it in America reached the new medical officer at the Food and Drug Administration…
lborkowski | September 17, 2010Earlier this week, FDA Commissioner Margaret Hamburg presented Frances Kelsey with the first in what will be a series of awards bearing Kelsey's name. Fifty years ago, as a new medical officer with the FDA, Kelsey refused to approve US sale of Kevadon, a drug widely recognized by its generic name, thalidomide. The drug was widely used as a sleep aid and anti-morning-sickness drug in Europe, but Kelsey questioned its safety.
While thousands of children were being born in Europe with missing limbs and other thalidomide-induced birth defects, the US avoided such widespread tragedy. In 1962,…