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Revision as of 05:30, 1 May 2006
Frances Oldham Kelsey (b. 24 June 1914) is a naturalized American pharmacologist most famous as a reviewer for the US Food and Drug Administration who refused to authorize thalidomide for market when she had serious concerns about the drug's safety. Kelsey's career intersected with the passage of laws strengthening the Food and Drug Administration's oversight of pharmaceuticals.
Birth and education
She was born as Frances Kathleen Oldham in Cobble Hill on Vancouver Island, British Columbia[1]. Kelsey graduated from high school at age 15[2], and enrolled at McGill University. There she received both a B.Sc.(1934) and a M.Sc.(1935) in pharmacology[1]. "Kelsey, on [a] professor's urging, wrote to EMK Geiling, MD, a noted researcher, [who] was starting up a new pharmacology department" asking for a position doing graduate work[2]. While working for Geiling, Kelsey assisted on research of Sulfanilamide. The research verified that Sulfanilamide caused 107 deaths (including many children). The next year, the US Congress passed the Federal Food, Drug, and Cosmetic Act of 1938[2]. Kelsey successfully completed her studies and received a Ph.D. in pharmacology at the University of Chicago in 1938[2]. Kelsey's work for Geiling is credited with her interest in teratogens, drugs that cause congenital malformations[3]. It was also during this time that she learned that some drugs do pass through the placental barrier[4].
Early career and marriage
Upon completing her Ph.D., Kelsey joined the University of Chicago faculty. Kelsey remained at the University of Chicago until 1954[1]. While there she met and she married, in 1943, fellow faculty member Dr. Fremont Ellis Kelsey[2].
Additionally, during her time at the University of Chicago, Kelsey received an M.D.[2]. After receving her M.D., Kelsey worked as an editorial associate for the American Medical Association Journal for two years. She then moved with her husband and two daughters to Vermillion, South Dakota where, between 1954 and 1957 she taught pharmacology at the University of South Dakota[1].
Work at the FDA and Thalidomide
In 1960, she was hired by the Food and Drug Administration in Washington, DC. At that time, "Kelsey was one of only seven full-time and four young part-time physicians reviewing drugs"[2] for the FDA. While working at the FDA, she withheld approval for the drug thalidomide, although it had already been approved in over 20 European and African Countries[5], and requested further studies[1]. Despite pressure from thalimide's manufacturer, Kelsey persisted in requesting additional studies to explain an English study which documented a nervous system side effect[2].
Her stand turned out to be justified when the births of deformed infants in Europe were linked to thalimide ingestion by their mothers during pregnancy[6]. Researchers discovered that the drug crossed the placental barrier and caused serious birth defects in infants[4]. She was hailed as a heroine[7] for averting a similar tragedy in the US[8]. Mintz said "[Kelsey] prevented ... the birth of hundreds or indeed thousands of armless and legless children."[7] As a result, the Food, Drug, and Cosmetics Act Amendments of 1962 were passed unanimously by Congress[6] and future drug testing was reformed, requiring "stricter limits on the testing and distribution of new drugs"[4] to avoid similar problems. Recognizing that "effectiveness [should be] required to be established prior to marketing."[6]
As a result of her efforts to prevent the approval of Thalidomide, Kelsey was awarded the President's Award for Distinguished Federal Civilian Service by President John F. Kennedy[8]. She returned to the FDA and played a key role in shaping and enforcing the 1962 Amendments [9] and directed the surveillance of drug testing at the FDA[1].
It was recognized that no drug is truly safe unless it is also effective, and effectiveness was required to be established prior to marketing -- a milestone advance in medical history
Awards
- In 1962 Kelsey was awarded the President's Award for Distinguished Federal Civilian Service[8].
- In 2000 she was inducted into the National Women's Hall of Fame[8].
- In 2001 she became a Virtual Mentor for the American Medical Association[9].
Legacy
The Frances Kelsey Secondary School in Mill Bay, British Columbia is named in her honour.
References
- ^ a b c d e f "Frances Kelsey". Canada Heirloom Series. Heirloom Publishing Inc. 1986. Retrieved 2006-04-30.
- ^ a b c d e f g h Bren, Linda (2001). "Frances Oldham Kelsey: FDA Medical Reviewer Leaves Her Mark on History". FDA Consumer magazine. Retrieved 2006-04-30.
{{cite journal}}: Unknown parameter|month=ignored (help) - ^ Spiegel, Rachel. "Research in the News: Thalidomide". Retrieved 2006-04-30.
- ^ a b c Simpson, Joanne Cavanaugh (2001). "Pregnant Pause". Johns Hopkins Magazine. 53 (4). Retrieved 2006-04-30.
{{cite journal}}: Unknown parameter|month=ignored (help) - ^ Rouhi, Maureen (2005). "Top Pharmaceuticals: Thalidomide". Chemical & Engineering News. 83 (25). American Chemical Society. Retrieved 2006-04-30.
{{cite journal}}: Unknown parameter|month=ignored (help) - ^ a b c "The Story Of The Laws Behind The Labels". FDA Consumer. 1981. Retrieved 2006-04-30.
{{cite journal}}: Unknown parameter|month=ignored (help) - ^ a b Mintz, Morton (1962-07-15). "'Heroine' of FDA Keeps Bad Drug Off of Market". The Washington Post. p. Front Page.
{{cite news}}:|access-date=requires|url=(help) - ^ a b c d "Dr. Frances Kathleen Oldham Kelsey". Retrieved 2006-04-30.
- ^ a b Cite error: The named reference
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