Biography & True Story Books:

Frances Oldham Kelsey, the FDA, and the Battle against Thalidomide

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Hardback
$84.99
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Description

The woman scientist who saved Americans from thalidomideIn 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, a drug routinely given to pregnant women to prevent morning sickness.As the FDA medical officer charged with reviewing Merrell Pharmaceutical's application for approval in 1960-61, 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 46 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. Those regulations, still in force today, required pharmaceutical companies to conduct phased clinical trials, obtain informed consent from participants in drug testing, and warn the FDA of adverse effects, and it granted the FDA important controls over prescription-drug advertising.One of a small minority of women to earn an advanced degree in science in the 1930s, Kelsey faced challenges that resonate with women scientists to this day. Revered by the public as a

Author Biography:

Cheryl Krasnick Warsh is Professor of History at Vancouver Island University in Nanaimo, Canada. Dr. Warsh has published books on the history of asylums, women's health, children's health, consumerism, and alcohol and drug use. She served as long-term editor-in-chief of the Canadian Bulletin of Medical History and was co-editor of Gender & History. Dr. Warsh was a Fulbright Fellow, AMS/Hannah Fellow, and the inaugural recipient of the Vancouver Island University Distinguished Researcher Award. In 2017, she was elected a Fellow of the Royal Society of Canada for her contributions to Canadian medical history.
Release date Australia
August 21st, 2024
Pages
288
Audience
  • Professional & Vocational
Illustrations
16 b&w halftones
ISBN-13
9780197632543
Product ID
36487552

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