The true story of how one woman prevented a national tragedy by doing her job

Dr. Frances Oldham Kelsey had only been at the Food and Drug Administration for about a month when she was tasked with reviewing a drug named thalidomide for distribution in America.

Marketed as a sedative for pregnant women, thalidomide is now available in Canada, Germany, and some African countries.

It could be a very simple approval. But for Kelsey, something isn’t right. There are no tests showing that thalidomide is safe for human use, especially during pregnancy.

Kelsey in his office at the FDA in 1960.

US Food and Drug Administration photo.

When Chemie Grnenthal released thalidomide in West Germany years ago, they called it a “wonder drug” for pregnant women. They promise that it will treat anxiety, insomnia, tension, and morning sickness and help pregnant women sleep.

What they didn’t advertise was its side effects.

Because it crosses the placental barrier between fetus and mother, thalidomide causes devastating and often fatal physical defects. In the five years it has been on the market, an estimated 10,000 babies worldwide have been born with defects caused by thalidomide. Only about 60% lived to their first birthday.

In 1961, the health effects of thalidomide were unknown. Only a few studies in the UK and Germany have begun to connect the dots between babies born with physical defects and the medication their mothers took while pregnant.

At first, that wasn’t Kelsey’s concern. He looked at the submission testimonials and found them “too glowing for support in the way of clinical back up.” He pressed the American manufacturer, the William S. Merrell Company of Cincinnati, to share research on how their drug affected human patients. They refused. Instead, they complained to his superiors for withholding approval. However, he refused to back down.

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A sample pack of thalidomide.

Photo by Stephen C. Dickson/Wikimedia Commons.

A sample package of thalidomide sent to UK doctors While more than 10,000 babies worldwide have been born with thalidomide-related birth defects, FDA historian John Swann credits Dr. Kelsey limiting the number of American children affected to just 17.

The following year, the manufacturer resubmitted its application to sell thalidomide six times. Each time, Kelsey asked for more research. Each time, they refused.

By 1961, thousands of mothers had given birth to babies with shocking and heartbreaking birth defects. Taking thalidomide early in their pregnancy is the one thing that connects them. The drug was quickly pulled from the shelves, almost disappearing by 1962.

Through dogged persistence, Kelsey and her team were able to prevent a national tragedy.

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Kelsey joined President John F. Kennedy in signing a new bill expanding the FDA’s authority in 1962.

US Food and Drug Administration photo.

In 1962, President John F. Kennedy honored Kelsey with the Federal Civilian Service Medal. He thanked her for her extraordinary judgment and for preventing a major tragedy of birth deformities in the United States:

I know that we all owe Dr. Kelsey. The relationship and the hope that we all have for our children, I think, indicates Dr. Kelsey, I am sure, how important his job 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, he’s not done yet. Later that year, the FDA approved new, stricter regulations for companies seeking drug approval, inspired in large part by Kelsey’s work on thalidomide.

Reached by email, FDA historian John Swann had this to say about Kelsey’s legacy: “[Her] Actions in the country have also made clear 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 really gave the impetus to ensure the passage of a comprehensive drug regulation bill that was more or less in disarray at the time the FDA considered the application. .”

Kelsey continued to work for the FDA until 2005. She died in 2015, at the age of 101, just days after receiving the Order of Canada for her work on thalidomide.

Bureaucratic approval work is rarely exciting and rarely celebrated. It’s a shame because it’s so critical.

People like Kelsey, who put the public’s health and safety above all else including their career deserve every ounce of our collective respect and admiration.

This story originally appeared on 05.20.16

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