Kevin E. Loughlin
Boston, MA, USA
Dr. Frances Oldham Kelsey
Her name has disappeared into the vault of medical history and her dedication to scientific rigor and patient safety has been largely forgotten. Yet her silent but tangible legacy continues to this day. Born in Canada in 1914, Frances Oldham Kelsey received a BSc (1934) and MSc (1935) in pharmacology from McGill University, and a PhD in pharmacology from the University of Chicago in 1938. She remained on the faculty and received her MD in 1950. Early in her career she worked on drug discovery for treating malaria. During this work she became aware that some drugs passed through the placenta. This observation would be of critical importance to her later career.1
In 1960 she moved to Washington DC and began to work at the Federal Drug Administration. One of her first assignments was to review an application by the William S. Merrell Company for the drug thalidomide, whose main indication was as a sleeping pill and for the treatment of morning sickness during pregnancy. The drug had originally been developed by a German firm, Grunenthal, which received a patent for it in 1954.2 It had been used extensively in Europe and Canada in the late 1950s and it was anticipated that FDA approval would be straightforward.
As Kelsey reviewed the new drug application, she became concerned. Much of the human data appeared anecdotal. There were no prospective trials and no studies on pregnant animals.3 Over the next year, there had come from Europe reports of severe birth defects, including phocomelia (congenitally short limbs) in infants whose mothers had taken the drug during pregnancy. Because of her background, Kelsey theorized that thalidomide crossed the placental barrier, since the birth defect risk appeared greatest when maternal ingestion occurred during the first trimester.
Merrell had already distributed samples to American physicians, which was permitted at that time. The firm began to exert pressure for drug approval and accused Kelsey of being a “fussy, stubborn, unreasonable bureaucrat.”4 In February 1961 she read a letter in the British Medical Journal that claimed that thalidomide might cause numbing in the extremities. She notified Merrell, which began its own inquiry. The company called the evidence ”inconclusive.”
As concern mounted in the United States, thalidomide samples distributed to American doctors were traced, but not all were recovered. Evidence continued to accrue and Merrell withdrew its drug application in March 1962. By that time, at least seventeen babies had been born in the U.S. with thalidomide-related birth defects.
Throughout this period, Senator Kefauver of Tennessee was waging a legislative battle to pass tougher laws regulating the pharmaceutical industry. As the thalidomide story began to unfold in the press, it enabled Kefauver to get legislation passed which required drug companies to prove the safety of new drugs, to report adverse reactions to the FDA, and to obtain consent from patients participating in clinical trials.5 It is likely this legislative accomplishment would not have been achieved, or at best would have been significantly delayed, were it not for the actions of Frances Kelsey.
In recognition of her work, President Kennedy awarded her the highest civilian honor, the President’s Award for Distinguished Civilian Service, on August 7, 1962. He commented, “Her exceptional judgment in evaluating a new drug for human use has prevented a major tragedy of birth deformities in the United States.”6 Andrew Jackson once said, “One man of courage makes a majority.” So it was with Frances Kelsey, and thousands of children were spared life-changing deformities.
- Frances Oldham Kelsey, Wikipedia, the free encyclopedia.https://Wikipedia.org/wiki/Frances_Oldham_Kelsey. Accessed 11/23/152.
- History of Thalidomide, News Medical Sciences. http://news-mmedical .net/health/History-of-Thalidomide.aspx. Accessed 1/12/17.
- Frances Oldham Kelsey, FDA scientist who kept thalidomide off U.S. market, dies at 101, Washington Post , August 7,2015. Accessed https://www.washingtonpost.com/national/health-science/frances-oldham-kelsey-heroine on 11/23/15.
- Frances Oldham Kelsey, WhoSaved U.S.Babies From Thalidomide, Dies at 101. NY Times August 7,2015. Accessed https://www.nytimes.com/2015/08/08/science/frances-oldham-kelsey on 1/12/17.
- FDA’s Frances Kelsey is a ‘profile in courage’ EETimes. Accessed http://www.eetimes.com/author.asp?section_id on 1/12/17.
- Frances Kathleen Oldham Kelsey< Biography. Changing the Face of Medicine. Accessed https://cfmedicine.nlm.nih.gov/physicians/biography_182.html on 1/12/17.
KEVIN E. LOUGHLIN, MD, MBA received his A.B. from Princeton University, M.D. from New York Medical College, MBA. from Boston University and MA. (Hon.) from Harvard University. He has been a practicing urologist for almost forty years and is currently the Vice President of the American Board of Urology and a member of the board of directors of the American Urological Association. He has had a lifelong interest in medical history.