The woman scientist who saved Americans from thalidomide 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, 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 “good mother of science,” she went
on to act as a formidable gatekeeper against other suspect drugs,
such as diesthylstilbestrol (DES) and laetrile. As part of the team
that tested anti-malarial drugs on prisoner volunteers during World
War II, she later was instrumental in the formulation of ethical
protocols for drug testing on prisoners and the vulnerable,
including the elderly and children. Yet behind the public
adulation, she faced professional jealousies and glass ceilings,
political interference with FDA's actions, and ongoing hostility
from pharmaceutical industry officials. She was sustained and
supported by family and friends, co-workers and mentors, and a
lifetime commitment to good science. Based upon FDA archival
records, private family papers, and interviews with family and
colleagues, this biography brings to light the efforts and legacy
of a pioneering woman of science whose contributions are still
influential today.
General
Imprint: |
Oxford UniversityPress
|
Country of origin: |
United States |
Release date: |
October 2023 |
Authors: |
Cheryl Krasnick Warsh
(Professor of History)
|
Dimensions: |
235 x 156mm (L x W) |
Format: |
Hardcover
|
Pages: |
288 |
ISBN-13: |
978-0-19-763254-3 |
Categories: |
Books
|
LSN: |
0-19-763254-8 |
Barcode: |
9780197632543 |
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