On This Day: Kennedy awards Frances Kelsey for preventing birth deformities - Aug. 7, 1962

[jgo]

(edited from Wikipedia)
"
Frances Kelsey was a pharmacologist and physician. As a reviewer for the U.S. Food and Drug Administration (FDA), she refused to authorize thalidomide for market because she had concerns about the lack of evidence regarding the drug's safety. Her concerns proved to be justified when it was shown that thalidomide caused serious birth defects. Kelsey's career intersected with the passage of laws strengthening FDA oversight of pharmaceuticals. Kelsey was the second woman to receive the President's Award for Distinguished Federal Civilian Service, awarded to her by John F. Kennedy in 1962.

In 1960, Kelsey was hired by the FDA in Washington, D.C. At that time, she "was one of only seven full-time and four young part-time physicians reviewing drugs" for the FDA. One of her first assignments at the FDA was to review an application for the drug thalidomide as a tranquilizer and painkiller with specific indications to prescribe the drug to pregnant women for morning sickness. Although it had been previously approved in Canada and more than 20 European and African countries, she withheld approval for the drug and requested further studies. Despite pressure from thalidomide's manufacturer, Kelsey persisted in requesting additional information to explain an English study that documented peripheral neuritis, a nervous system side effect. She also requested data showing the drug was not harmful to the fetus.

Kelsey's insistence that the drug should be fully tested prior to approval was vindicated when the births of deformed infants in Europe were linked to thalidomide ingestion by their mothers during pregnancy. Researchers discovered that the thalidomide crossed the placental barrier and caused serious birth defects. She was hailed on the front page of The Washington Post as a heroine for averting a similar tragedy in the U.S.. Kelsey insisted that her assistants, Oyama Jiro and Lee Geismar, as well as her FDA superiors who backed her strong stance, deserved credit as well. The narrative of Kelsey's persistence was used to help pass rigorous drug approval regulation in 1962.

As a result of her blocking American approval of thalidomide, Kelsey was awarded the President's Award for Distinguished Federal Civilian Service by John F. Kennedy on August 7, 1962. After receiving the award, Kelsey continued her work at the FDA. There she played a key role in shaping and enforcing the 1962 amendments. She also became responsible for directing the surveillance of drug testing at the FDA.
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https://en.wikipedia.org/wiki/Frances_Oldham_Kelsey

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[mahatmakanejeeves]

1. It's also the day she died, in 2015.

And good morning.

[jgo]

2. Good morning to you too.

[appalachiablue]

3. K/R