Frances Oldham Kelsey, the FDA, and the Battle Against Thalidomide [Audiobook] [#795256]

Free Download Frances Oldham Kelsey, the FDA, and the Battle Against Thalidomide (Audiobook)
English | ASIN: B0CQQ5SMYW | 2024 | 16 hours and 41 minutes | M4B@64 kbps | 476 MB
Author: Cheryl Krasnick Warsh
Narrator: Andrea Gallo
In the early 1960s, Dr. Frances Oldham Kelsey of the U.S. Food and Drug Administration became one of the most celebrated women in America when she prevented a deadly sedative from entering the U.S. market. A Canadian-born pharmacologist and physician, Kelsey saved countless Americans from the devastating side effects of thalidomide, routinely given to pregnant women to prevent morning sickness. As the FDA medical officer charged with reviewing Merrell Pharmaceutical's application for approval in 1960-1961, Kelsey was unconvinced that there was sufficient evidence of the drug's efficacy and safety. Despite substantial pressure, she held her ground for nineteen months while the extent of the drug's worldwide damage became known-thousands of stillborn babies, as well as at least 10,000 children across forty-six countries born with severe deformities such as missing limbs, arms, and legs that resembled flippers, and improperly developed eyes, ears, and other organs. As a result of Kelsey's efforts, thalidomide was never sold in the United States. The incident led Congress to pass the 1962 Drug Amendment, which fundamentally changed drug regulation in America.