Prompt Cast
Frances Kelsey: The Hero Who Saved American Children from Thalidomide
TLDR Frances Kelsey, an FDA scientist in the 1960s, rejected the drug thalidomide due to lack of scientific data and reports of birth defects. Her refusal prevented the release of the drug in the United States and led to stricter FDA approval processes.
Timestamped Summary
00:00
Frances Kelsey is a hero of the FDA who may not be well-known, but she received recognition for her work.
02:06
Frances Kelsey worked for the FDA in the 1960s and noticed that the process for getting drugs on the market was not rigorous, leading her to make significant changes.
04:31
Frances Kelsey's job at the FDA was to review scientific data and approve or disapprove new drugs, and about seven months into her position, she came across an application for a drug called thalidomide.
06:46
Frances Kelsey found reports of neuropathy and a lack of scientific data on the use of thalidomide for morning sickness, leading her to reject the drug application.
08:51
Frances Kelsey held her ground and requested more scientific data on thalidomide, while doctors in Australia and Germany noticed a cluster of rare birth deformities in children whose mothers had taken the drug.
10:59
Frances Kelsey's refusal to approve thalidomide in the United States prevented its release and protected American children from the birth defects caused by the drug, although a small number of children in the US were still affected.
12:47
Frances Kelsey's actions led to the passing of the Kephalver-Harris amendment, which tightened and lengthened the FDA approval process for drugs.
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Society & Culture
