Frances Kelsey: The Woman Who Saved American Babies From Thalidomide

Five years ago today, Frances Oldham Kelsey passed away. Don’t know who she was?
That is okay, but please read on.

She was born in 1914 and grew up in Canada, performing excellently in school and college. She spent part of her high school years as the only female in an all boys school. In 1935, already with two degrees, she applied to the University of Chicago to do high level pharmacology research. The highly regarded Doctor in charge of the program thought the application was from a man, so he accepted her.

During the next two decades she worked as a researcher and instructor at both the University of Chicago, and the University of South Dakota. During this time she began focusing on the effect certain drugs were having on unborn babies.

In 1960, she was hired by the Food and Drug administration in Washington D.C. She worked on researching and providing approval or denial to new drugs. She was one of only eleven people in such a role.

One of her first assignments was to review a new drug called “Thalidomide” which was a tranquilizer and pain killer designed to help pregnant women with morning sickness. Thalidomide had already been approved in Canada and 46 other countries.

Dr. Kelsey was in charge of determining whether or not the new drug would be made legal in the United States. She didn’t like it. She said there wasn’t enough information available. Later, she would say that she just didn’t feel that its manufacturers where being honest and forthright.

She kept issuing denials, asking for more evidence and information about the new drug, which was slow in coming. This was unusual at this time, as most new drugs were just awaiting the rubber stamp. Tremendous pressure began to mount on Ms. Kelsey to approve thalidomide.

She wouldn’t budge.

While the drug remained unapproved for use in the United States in 1961, reports started coming in from around the world of babies being born with severe deformities. Babies were being born without limbs, with no visible ears, with eyes that wouldn’t open, and with “flipper” like arms and legs. There is no certain number of how many babies suffered from thalidomide, but estimates range as high as 100,000.

(Think Billy Joel “We Didn’t Start the Fire” when he says “children of thalidomide”)

Because of her persistence and vigilance, Dr. Kelsey saved the babies of the United States from the perils of thalidomide.

She became a national sensation, with newspapers and magazines from all across the country hailing her efforts. The front page of the Washington Post read “her skepticism and stubbornness … prevented what could have been an appalling American tragedy.”

She received the “Distinguished Federal Civil Service Award” from President Kennedy.
Most importantly, her efforts led to landmark legislation being passed in the United States to tighten the controls and restrictions on new drugs being released for public use.

She worked for the F.D.A. until she was 90 years old. The award for the F.D.A.’s outstanding employee is called “The Kelsey Award.”

Always remember the importance of science and the smart hard working people who often save the lives and health of us and the ones we love. Honor the strength they often have to show in the face of pressure and skepticism in order to do what is best for our collective safety.

Also, remember this story as they announce progress towards a vaccine for Covid. We all want this to be over as fast as possible, but hopefully there will be a Frances Kelsey to make sure it is done the right way.

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