On This Day in History: August 7

Thalidomide

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Listen to the fucking science. That’s what Canadian-American physician/pharmacologist Frances Oldham Kelsey said regarding thalidomide, preventing a disaster for countless children in the U.S.

--On This Day in History, Shit Went Down: August 7, 1962--

In 1960 Kelsey was hired by the FDA to review drugs. Thalidomide was one of her first assignments. You know how people new to a job, especially women in the patriarchal-as-hell 1960s, might be afraid of making waves? Frances said fuck that.

Thalidomide was being used as a tranquilizer and painkiller, and the manufacturer was pushing it as a treatment for pregnant women with morning sickness. It had already been approved for use in Canada and almost two dozen European and African countries. The drug’s German manufacturer, Grünenthal, pressured her to approve the drug, but she was concerned about it crossing the placental barrier, an area Kelsey had expertise in due to her previous work with malaria drugs.

And so, she told the company she needed more data to show the drug would not be harmful to the fetus of anyone who took it. This critical delay caused by Kelsey demanding further studies allowed time to see the horrifying effects of the drug in countries where it had been approved. Her instinct to withhold approval was correct, because the drug did cross the placental barrier and caused myriad serious birth defects.

It was estimated that approximately 10,000 people were affected by their mothers taking thalidomide, of which roughly 40% died at birth. The effects on those who survived included limb deformities, as well as problems with the heart, eyes, and urinary tract.

Kelsey was celebrated on the front page of The Washington Post for her tough stance. She said that her assistants and supervisors deserved credit for backing her up in her refusal to approve the drug. On August 7, 1962, she was awarded the President’s Award for Distinguished Federal Civilian Service by John F. Kennedy.

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