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In 1960, during her first month at the Food and Drug Administration, Dr. Frances Oldham Kelsey took a bold stance against inadequate testing and corporate pressure when she refused to approve release of thalidomide in the United States. The drug had been used as a sleeping pill and was later proven to have caused thousands of birth deformities in Germany and Great Britain.
Born Frances Oldham in 1914, on Vancouver Island, British Columbia, she earned both her bachelor of science and master of science degrees from McGill University, Montreal, in 1934 and 1935. In 1938 she earned her Ph.D. from the University of Chicago, and went on to teach there from 1938 to 1950. Dr. Frances Oldham married Dr. Fremont Ellis Kelsey, a fellow faculty member at University of Chicago, in 1943. Their two daughters were born while she earned her medical degree at the University of Chicago Medical School.
Dr. Kelsey then worked as an editorial associate at the American Medical Association before teaching pharmacology at University of South Dakota from 1954 to 1957. She was a general practitioner there from 1957 to 1960. In 1960 she moved to Washington, D.C., and began her long and distinguished career at the Food and Drug Administration, where she later became chief of the Division of New Drugs, director of the Division of Scientific Investigations, and deputy for Scientific and Medical Affairs, Office of Compliance.
Dr. Frances Kelsey took her stand against thalidomide during her first month at the Food and Drug Administration, on her first assignment. The task was supposed to be a straightforward review of a sleeping pill already widely used in Europe, but Kelsey was concerned by some data suggesting dangerous side effects in patients who took the drug repeatedly. While she continued to withhold approval, the manufacturers tried everything they could to get around her judgement.
In November 1961, reports began to emerge in Germany and the United Kingdom that mothers who had taken thalidomide during pregnancy were now having babies with severe birth defects. Dr. Helen Taussig learned of the tragedy from one of her students and traveled to Europe to investigate. By testifying before the Senate, Tauusig was able to help Kelsey ban thalidomide in the United States for good. At least 4000 children in Europe were affected by the drug, but thanks to Kelsey's rigorous professionalism a similar tragedy was averted here in America.
On August 7, 1962, President John F. Kennedy awarded Frances Kelsey the highest honor given to a civilian in the United States, the President's Award for Distinguished Federal Civilian Service. She was the second woman to ever receive the award. Kennedy acknowledged "Her exceptional judgment in evaluating a new drug for safety for human use has prevented a major tragedy of birth deformities in the United States. Through high ability and steadfast confidence in her professional decision she has made an outstanding contribution to the protection of the health of the American people."
Kelsey helped shape and enforce amendments to FDA drug regulation laws to institutionalize protection of the patient in drug investigations. These regulations required that drugs be shown to be both safe and effective, that informed consent be obtained from patients when used in clinical trials, and that adverse reactions be reported to the FDA. In 1995, the town of Mill Bay, British Columbia, honored Dr. Kelsey by naming the Frances Kelsey Secondary School for her. In 2000, Kelsey was inducted into the National Women's Hall of Fame, and in 2001, at the age of 87, she became a Virtual Mentor for the American Medical Association.
