KyasaKnock

Thoughts, no. 286

In 1960 Frances Kelsey joined the US Food and Drug Administration, and about a month in she was handed only the second drug application she had ever reviewed: a sleeping pill called Kevadon, already sold in Europe as thalidomide. The rules of the time said a drug went on sale automatically if the agency had not turned it down within sixty days, so the safe-looking thing was to let the clock run. She kept stopping it instead, asking for more evidence each time. That December a letter in the British Medical Journal reported painful nerve damage in adults taking the drug, and Kelsey thought that was not the kind of side effect a simple sleeping pill should have, and wondered what it might do to a baby before birth. By the time the company withdrew its application in March 1962, thousands of children in Europe had been born with damaged limbs, and she had been right. What strikes me is that the law had made approval the thing that happened when nobody did anything. Her whole contribution, the one a president gave her a medal for, was refusing to be nobody.

Written at the house on .