Dr. Francis Oldham Kelsey had been at the Food and Drug Administration for only about a month when he was assigned the task of reviewing a drug called thalidomide for distribution in the United States.
Thalidomide, marketed as a sedative for pregnant women, was already available in Canada, Germany, and several African countries.
It could have been a very simple approval. But something didn’t go right for Kelsey. There were no trials showing that thalidomide was safe for human use, especially during pregnancy.
Kelsey in his office at the FDA in 1960.
Image by US Food and Drug Administration.
When Kemi Grönenthal released thalidomide in West Germany years ago, she called it a “wonder drug” for pregnant women. They promised that it would treat anxiety, insomnia, stress and morning sickness and help pregnant women sleep.
What they didn’t advertise were its side effects.
Because it crosses the placental barrier between the fetus and mother, thalidomide causes devastating, often fatal, physical defects. During the five years it was on the market, an estimated 10,000 babies globally were born with thalidomide-induced defects. Only about 60% survive past their first birthday.
In 1961, the health effects of thalidomide were not well known. Only a few studies in the UK and Germany were beginning to link the link between babies born with physical defects and the medications their mothers took during pregnancy.
At first, Kelsey wasn’t worried. She looked at the testimonials in the submission and found them “too glowing to support in the way of clinical back up”. He worked with the American manufacturer, William S. Merrell pressured the company to share research on how their drug affected human patients. He refused. Instead, he complained to his superiors to block the approval. Still he refused to back down.
A sample pack of thalidomide.
Image by Stephen C. Dixon/Wikimedia Commons.
A sample pack of thalidomide was sent to doctors in the U.K. While more than 10,000 babies worldwide were born with thalidomide-related birth defects, FDA historian John Swann credited Dr. Gave it to Kelsey.
Over the following year, the manufacturer would resubmit its application to sell thalidomide six times. Each time, Kelsey asked for more research. Every time he refused.
By 1961, thousands of mothers were giving birth to babies with shocking and heartbreaking birth defects. The only thing connecting them was taking thalidomide early in pregnancy. The drug was soon taken off the shelves and had mostly disappeared by 1962.
Through sheer perseverance, Kelsey and her team had prevented a national tragedy.
Kelsey joins President John F. Kennedy at the signing of a new bill expanding the FDA’s authority in 1962. Joined Kennedy.
Image by US Food and Drug Administration.
In 1962, President John F. Kennedy awarded Kelsey the Federal Civilian Service Medal. He thanked her for her extraordinary decision and for preventing a major tragedy of birth defects in the United States:
I know we are all very grateful to Dr. Kelsey. I think the relationship and expectations we all have for our children indicate to Dr. Kelsey, I’m sure, how important his work and those who work with him are to protect our families. So, Doctor, I know you know how much the country appreciates what you’ve done.”
But, it was not complete yet. Later that year, the FDA approved new, stricter rules for companies seeking drug approval, largely inspired by Kelsey’s work on thalidomide.
Reached via email, FDA historian John Swann said this about Kelsey’s legacy: “[Her] The actions have also made clear to the nation the important public health role that drug regulation and the FDA itself play in public health. The revelation of the global experience with that drug and America’s close call actually provided the impetus to safely pass a comprehensive drug regulation bill, which was more or less floundering during the time the FDA was considering the application. “
Kelsey continued to work for the FDA until 2005. He died in 2015 at the age of 101, just days after receiving the Order of Canada for his work on thalidomide.
Bureaucratic approval work is rarely thrilling and often not celebrated. It’s a shame because it’s very serious.
People like Kelsey, who put public health and safety above all else, including their careers, deserve our collective respect and admiration.
This story was originally published on 05.20.16
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