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Frances Kelsey & Thalidomide
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Frances Kelsey & Thalidomide

Frances Kelsey & Thalidomide

FDA reviewer Frances Kelsey held off approval 14 months, sparing the US the worst of thalidomide.

Chapter 1

A Sedative With No Ceiling

1:04

In 1954, chemists Wilhelm Kunz and Herbert Keller at Chemie Grunenthal, a West German firm founded in 1946, were hunting for a new drug from glutamic-acid research when they produced a compound that calmed test animals so thoroughly that no dose seemed to kill them. Company leadership, guided by head of research Heinrich Mückter, a scientist who had worked for the Nazi regime during the war, saw an opportunity no barbiturate could match. Grünenthal applied for a patent on the compound in May 1954 and launched it on October 1, 1957 as Contergan, sold in Germany without a prescription and marketed as completely non-toxic. Soon it was pushed for morning sickness too, though it had never been tested on a single pregnant animal or woman. Licensees sold it abroad as Distaval and Softenon. Between 1957 and 1961, Germans alone swallowed some 300 million daily doses, taken by roughly 5 million people trusting a label that promised no harm.

Frequently Asked Questions

Why did Frances Kelsey refuse to approve thalidomide in the United States?

Kelsey found Merrell's application built mostly on doctor testimonials rather than controlled studies, and she specifically worried that pregnancy might change how the body absorbed the drug. Her earlier work tracing a poison in Elixir Sulfanilamide had taught her to distrust manufacturer safety claims lacking rigorous data.

How many babies were affected by thalidomide worldwide compared to the United States?

By most counts thalidomide caused severe birth defects in roughly 10,000 to 12,000 babies across more than 40 countries. The United States recorded only about 17 confirmed cases, because thalidomide was never formally approved for sale there.

What law resulted from the thalidomide scandal in America?

President Kennedy signed the Kefauver-Harris Amendments into law on October 10, 1962. The law required drug makers to prove both safety and effectiveness before marketing a drug and to report adverse events to regulators.

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