With everyone anxious about getting a coronavirus vaccine, I thought I would highlight a very different scenario. One that tells the story about Frances Oldham Kelsey, a Canadian pharmacologist who came under intense pressure to sign off on a new drug in the early 1960s.
Born in 1914 on Vancouver Island, British Columbia, Frances came to the United States in the 1930s to pursue medical training. She received her Ph.D. in pharmacology from the University of Chicago in 1938 and her M.D., also from Chicago in 1950.
Along the way, while in medical school, she married Dr. Fremont Kelsey and later gave birth to two daughters.
Continuing to carry dual citizenship, the now Dr. Frances Kelsey was hired by the U.S. Food and Drug Administration in 1960 to review the drug licensing program.
Meanwhile, in Germany, a pharmaceutical company had synthesized a new sedation drug to be used as a safe alternative to barbiturates. The drug, known as thalidomide, did not appear to be toxic or have any detrimental side effects.
Although the drug’s intended use was as a sedative, it also seemed to quell nausea in pregnant women, thereby alleviating the issue of ‘morning sickness.’
At first, the drug was marketed as an anti-flu medication and could be procured in Europe without a prescription. Thousands of free samples were distributed to doctors in Europe, Japan, and the United States.
In a rush to get the drug approved, sufficient long-term studies were lacking.
Thalidomide seemed to be a miracle drug, and although the German pharmaceutical company had no reliable evidence to its complete safety, the marketing campaign was successful.
Frances and her family had moved to Washington D.C. and it was her first month on the job for the Food and Drug Administration. The German pharmaceutical company attempted to woo the American agency in the hopes of receiving the go-ahead for licensing in the United States. Frances hesitated because there was a lack of clinical evidence about potential side effects.
She studied the research, then put her new career on the line, not willing to compromise, and flatly refused.
Within months of her refusal, disturbing reports began to surface that babies born to mothers who had taken the thalidomide were born with severe deformities. By November 1961, the United Kingdom pulled the drug from their markets, and then Germany followed suit.
But it was too late for thousands of unborn babies, some of whom would be born to American mothers who had received the thalidomide samples from their doctors.
As 1961 turned into 1962, American magazines picked up the thalidomide story and published heartbreaking photos of the babies born with deformities.
Over 10,000 children worldwide were born with thalidomide defects, missing arms and or legs, fingers and toes, extra fingers and toes, partial hearing and or vision loss, and even paralysis of facial muscles. Many thalidomide infants died within days of birth.
The United States government quickly advised all doctors to stop dispensing the drug.
On August 7, 1962, President John F. Kennedy awarded Frances Kelsey the President’s Award for Distinguished Federal Civilian Service. In his speech, he praised Frances’s diligent efforts that helped to minimize the thalidomide tragedy in America.
She was the second female ever to have been given this award.
Dr. Frances Oldham Kelsey spent the remainder of her 45-year career with the F.D.A. and, in 2000, was inducted into the National Women’s Hall of Fame. She died in 2015, at the age of 101, secure in the knowledge that she had made the right decision in 1960.
Sometimes, strong women are those who do not rush to agree with the popular ideas of the day.
If you enjoyed Frances’s story and are not yet a follower of Strong Women, do sign up at the bottom right side of the blog with your email. If you would like the addition of a small one-page newsletter once a month from me, please contact me, linda@lindasittig.com.
Till next month, you can catch me on Twitter @LHsittig or Instagram @LHsittig or Facebook at Linda Harris Sittig. The links to my three novels of historical fiction, featuring strong female protagonists are:
www.amzn.com/1940553024 Cut From Strong Cloth
www.amzn.com/1940553067 Last Curtain Call
www.amzn.com/1940553091 Counting Crows
~ Linda – please everyone, stay healthy!
Great story! Just shows that whistle blowers and those who don’t follow orders like sheep are often the unsung heroes society needs!
This story hits home as I have a first cousin who was born without an ear due to Thalidomide. Thanks, Linda and hope you and yours are keeping well and safe!
Karen, I remember seeing a young girl with hands where her shoulders should have been. My mother gently explained to me then about thalidomide. I have never forgotten that image. But it took becoming an adult for me to realize the courage that Frances Kelsy had going against the norms of her time.
linda
I can draw parallels between Francis Oldham Kelsey and Dr. Deborah Birx from the COVID19 team. Dr. Birx relays facts during the the daily briefings. Valid information during this time offsets some of the anxiety. She had her sights focused on medicine and research at the age of 16. She delivers grim news with compassion. Thanks for writing about a scientist who relied on research and wouldn’t bend under pressure. Keep up the good work!
Thanks, Carol. I, too, admire Dr. Birx and how she remains calm in the face of such a calamity. I knew about thalidomide, but never heard about Frances Kelsy until this year!
linda
A great post. My mom was offered a sample of thalidomide when she was pregnant with my younger brother but she refused it. Later, when the news of the consequences came out, she was so glad she had done so. Another strong woman who stood her ground.
Always fascinating stories. Thank you for writing and sharing. Stay well.