Thalidomide and Dr. Frances Kelsey

Dr. Frances Kelsey & President KennedyThere aren’t many people who can singlehandedly claim that they prevented thousands of children from being born with serious birth defects. Yet, Dr. Frances Oldham Kelsey is one woman who is famous for that reason.

You may have heard of thalidomide. It is a drug that is used to treat a skin disease caused by leprosy, but in the 1950’s and 60’s it was given to pregnant women to lessen morning sickness. Unfortunately, thalidomide caused serious limb (arms and legs) defects in thousands of children around the world. But, due to the vigilance of Dr. Kelsey, medical officer at the FDA (Food and Drug Administration) thalidomide was never allowed to be licensed in the U.S.

On August 7th, Frances Oldham Kelsey, MD, PhD, passed away at the age of 101. She was a wife, mother, and a highly educated woman. She earned a doctorate degree (PhD) in pharmacology and was one of seven women in her class of 100 to graduate from the University of Chicago Medical School in 1950. She joined the FDA in 1960.

In her autobiography, she writes “I had been hired as a medical officer and this meant that I would review the medical part rather than the pharmacology of new drug applications.” Despite considerable pressure to allow thalidomide to be available in the U.S., Dr. Kelsey followed her instinct (aided by her excellent education and training) to not allow the drug to be licensed. She says it was particularly important to investigate this drug because “When you give a drug to a pregnant woman you are exposing, in fact, two people to the drug, the mother and the child.” Dr. Kelsey felt that until it was established that the drug was safe for pregnant women, it should not be given to them. “Our objections… were really on theoretical grounds, largely based on the fact that there was no evidence that it was safe. Until we had such evidence we had to question the safety.”

Dr. Kelsey recalls that this near-miss disaster “caught the eye of the persons who were pressing for drug reform… In next to no time, the fighting over the new drug laws that had been going on for five or six years suddenly melted away, and the 1962 amendments were passed almost immediately, and unanimously.”

Later, an important amendment to the law provided that patients must know about and consent to taking a new, unapproved drug in a clinical trial – a very important aspect in drug testing that continues to this day.

Dr. Kelsey notes that “Nowadays we know exactly what is being tested and who is testing it and we get results back as soon as possible. Then if we get reported adverse reactions, we may stop the studies…”

Dr. Kelsey received the President’s Award for Distinguished Federal Civilian Service in August 1962, from President John F. Kennedy. She received numerous other awards, commendations and honorary degrees. According to the FDA, “in October 2000 Dr. Kelsey was inducted into the National Women’s Hall of Fame, and in 2010 Commissioner Hamburg conferred the first Dr. Frances O. Kelsey Award for Excellence and Courage in Protecting Public Health on Dr. Kelsey herself.”

We are grateful for Dr. Kelsey’s vigilance and tireless efforts in protecting babies, women and all individuals in the United States. Her honorable legacy will never be forgotten.

 

Photo: Courtesy of US National Library of Medicine. Frances O. Kelsey receives the President’s Award for Distinguished Federal Civilian Service from President John F. Kennedy, 1962.

Questions?  Text or email them to AskUs@marchofdimes.org.

 

Tags: , , , ,

3 Responses to “Thalidomide and Dr. Frances Kelsey”

  1. Susan Says:

    Technically there were thalidomide babies born in the United States. Albeit not in the thousands like could have been but approximately 35 babies were born. The moms were given sample tablets from their Drs.
    But because thalidomide didn’t ‘officially ‘ enter the states, these now adults are having an impossible time getting recognized for compensation.

  2. Susan Says:

    I happen to know this because I am a Canadian thalidomide survivor who knows those American survivors.

  3. Barbara Says:

    Hi Susan,

    You are correct. Some children that were born in the US were affected by thalidomide. In some cases, the medication was obtained overseas and in other cases, physicians may have prescribed it without understanding it had not yet been licensed for use in the US. However, due to Dr. Kelsey’s vigilance, far fewer children were affected than may have been, had thalidomide been approved for use in America. Thanks so much for your comments.