She Was Brave Enough To Deny FDA Approval On A Drug That Could Have Caused A Lot Of American Families Pain And Heartbreak

Diana Vyshniakova - - illustrative purposes only, not the actual person

It’s fascinating to think about how far civilization has come regarding different kinds of medicine and how much further we can go.

Back in the 1950s and 60s, one woman was brave enough to deny FDA approval on a drug that could have caused a lot of American families a lot of pain and heartbreak.

That woman was Dr. Frances Kelsey, known in medical history as a hero for what she did while working for the U.S. Food and Drug Administration.

Frances was born in 1914 in Cobble Hill, British Columbia, Canada. She had an interest in science at a young age. By the time she was 20, she got her master’s degree from McGill University in Montreal before moving to Chicago, Illinois, and receiving a Ph.D. in pharmacology at the University of Chicago.

In 1942, Frances became a faculty member at the University of Chicago, where she met her husband, Dr. Fremont Kelsey, another staff member. Frances managed to earn her M.D. in 1950 while working at the university and took a brief position as an editorial associate for the American Medical Association Journal.

In 1960, Frances and her family moved to Washington, D.C., where she was hired as a drug reviewer for the FDA.

One of Frances’ very first assignments was to review an application submitted for the drug thalidomide. Years prior, thalidomide had been approved in several countries worldwide, including Germany, where it was sold over the counter.

Thalidomide was initially intended to be a sedative for those with anxiety before pregnant women were prescribed the drug to help with their morning sickness.

When thalidomide was submitted to the FDA for review by the company Richardson-Merrell, it was listed as a drug to help with morning sickness. Part of Frances’ job was to search through a ton of trial data and started showing concern about the lack of data surrounding thalidomide’s effect on pregnancies.

Diana Vyshniakova – – illustrative purposes only, not the actual person

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