Who are the modern-day Frances Kelseys?
Frances Kathleen Oldham Kelsey, Ph.D., M.D., physician and pharmacologist, was a leading compliance officer with the Federal Food and Drug Administration.
She became nationally known in the 1960s when she withstood great pressure by a leading drug company to quickly approve the drug thalidomide, which was then widely used in Europe primarily to allay morning sickness suffered during pregnancy.
Demanding more testing before she would consider approval, Dr. Kelsey saved countless women in the United States from giving birth to terribly deformed children. President Kennedy awarded Kelsey the President’s Medal for Distinguished Service for her exceptional judgment in evaluating this new drug. Kelsey was only the second woman to receive this award – the highest award the government gives to civilians.
Dr. Kelsey brought to the FDA the rigorous standards that typified high quality research in major academic institutions. Her alertness and careful review of the thalidomide application and the subsequent evidence of the danger of that drug resulted in significant strengthening of drug legislation in the United States.
Today drug companies must prove not only that drugs are safe, but also that they are effective. Perhaps even more important, drug companies now have to submit enough research to the FDA to prove a drug’s safety before it can be tested on humans.
Dr. Kelsey helped open the door to women in medical and scientific research by proving that women can compete at top academic institutions. She received her Ph.D. in pharmacology in 1938 from the University of Chicago and became an instructor and then assistant professor of pharmacology there.
In 1950, after many years of course work, she earned her M.D. degree, also from Chicago. This was at a time when less than ten percent of graduate students and medical students in her field were women. Dr. Kelsey authored numerous articles in well recognized scientific journals and was the recipient of several prestigious awards and honorary degrees.
A woman of courage and a woman of reason. Dr.Kelsey demanded of herself and others in her profession high standards of science and integrity.
Frances Oldham Kelsey, recipient of the highest recognition attainable for a U. S. civil servant for her role in saving perhaps thousands from death or life-long incapacitation, had a long an impressive career both before that turning point in medical history and afterwards. Born in Cobble Hill, Vancouver Island, B. C., she had an early interest in science.
In 1934 she earned her B. Sc. from McGill University, and in the following year received the Master’s degree in pharmacology. She continued her work in pharmacology at the University of Chicago, where she earned her Ph. D. in 1938 and also the M. D. in 1950. During this period she also did editorial work for the American Medical Association, where she reviewed papers on the latest in therapeutics.
Beginning in 1954 Dr. Kelsey taught pharmacology at the University of South Dakota and practiced general medicine.
Six years later she accepted an offer from the Food and Drug Administration to become one of just a handful of medical officers. Their principal duty was to review new drug applications, a legal requirement in which manufacturers had to provide evidence of a drug’s safety before it could go on the market.
One of the first applications she was assigned was for thalidomide, which was already available in dozens of countries around the world. Dr. Kelsey, despite constant pressure from the company, refused to approve the application because of its inadequate evidence.
The company continued to send in what they believed was proof of thalidomide’s safety, but Dr. Kelsey adamantly insisted on scientifically reliable evidence, which she felt the application sorely lacked. Approximately a year later researchers in Germany and Australia linked thalidomide to clusters of rare, severe birth defects—hands and feet projecting directly from the shoulders and hips—that eventually were shown to involve thousands of babies.
The drug was never marketed in the U. S., and the impact of the near disaster here helped to pass a pending bill that fundamentally changed drug regulation, the 1962 Drug Amendments.
Dr. Kelsey moved on to head the Investigational Drugs Branch, and from the late 1960s until the 1990s she led the Division of Scientific Investigations, which oversaw clinical investigators, ensuring the scientific integrity of the data on which the agency’s drug decision-making were largely based.
Her contributions have been widely recognized through Presidential and other awards, honorary academic degrees, and educational facilities named after her. Also, 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.
I trust the irony of the FDA’s eulogy is not lost on you. Dr Kelsey must be turning in her grave. If only she had lived on another few years, her valuable insight would have been very welcome today.
Alas, today there are no such women like Dr Kelsey in the FDA or indeed in any other public health service. Instead we’ve got women like June Raine and Viki Male. Enough said. And then there’s Susan Oliver, who spends an awful lot of time and effort trying to discredit honest researchers and lose them their licences to practice.
Of course I’m biased but these are my top three ladies with the same integrity and fortitude as Dr Kelsey in this, our thalidomide moment, looking out for the people of child-bearing capacity and their offspring:
- Dr Clare Craig
- Dr Jessica Rose
- Dr Ros Jones
- Dr Tess Lawrie
- Dr Mary Bowden
- Dr. Naomi Wolf
- Dr Meryl Nass
- Dr Simone Gold
- Julie Ponesse
- Dr Sam Bailey
- Brook Jackson
I am so honoured to have collaborated with almost all of them so far.
See more here substack.com
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