Frances Oldham Kelsey

Frances Kathleen Oldham Kelsey, Ph.D., M.D., (b. 24 June 1914) is a naturalized American pharmacologist, most famous as the reviewer for the U.S. Food and Drug Administration (FDA) who refused to authorize thalidomide for market because she had concerns about the drug's safety. Her concerns proved to be justified when it was proven that thalidomide caused birth defects. Kelsey's career intersected with the passage of laws strengthening the FDA's oversight of pharmaceuticals.

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Birth and education

Born 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 to study pharmacology. At McGill she received both a B.Sc.(1934) and a M.Sc.(1935) in pharmacology,^[1] and "on [a] professor's urging, wrote to EMK Geiling, M.D., a noted researcher [who] was starting up a new pharmacology department at the University of Chicago," asking for a position doing graduate work.^[2] Despite Geiling assuming that Frances was a man,^[3] she accepted the position and began working for Geiling. During her second year, Geiling was retained by the FDA to research unusual deaths related to Elixir Sulfanilamide, a sulfonamide medicine. Kelsey assisted on this research project, which showed that the 107 deaths were caused by the use of diethylene glycol as a solvent. The next year, the United States Congress passed the Federal Food, Drug, and Cosmetic Act of 1938.^[2] That same year 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 - that is, drugs that cause congenital malformations.^[4]

Early career and marriage

Upon completing her Ph.D., Kelsey joined the University of Chicago faculty. In 1942, like many other pharmacologists, Kelsey was looking for a synthetic cure for malaria. As a result of these studies, Kelsey learned that some drugs are able to pass through the placental barrier.^[5] While there she also met fellow faculty member Dr. Fremont Ellis Kelsey whom she married in 1943.^[2]

While on the faculty at the University of Chicago, Kelsey received an M.D.^[2] She supplemented her teaching with work as an editorial associate for the American Medical Association Journal for two years. Kelsey left the University of Chicago in 1954, and decided to take a position teaching pharmacology at the University of South Dakota, and moved with her husband and two daughters to Vermillion, South Dakota, where she taught until 1957.^[1]

Work at the FDA and thalidomide

  In 1960, Kelsey was hired by the FDA in Washington, DC. At that time, she "was one of only seven full-time and four young part-time physicians reviewing drugs"^[2] for the FDA. One of her first assignments at the FDA, was to review the drug thalidomide (under the tradename Kevadon). Even though it had already been approved in over 20 European and African countries,^[6] she withheld approval for the drug, and requested further studies.^[1] Despite pressure from thalidomide's manufacturer, Kelsey persisted in requesting additional information to explain an English study which documented a nervous system side effect.^[2]

Kelsey's insistence that the drug should be fully tested prior to approval was dramatically vindicated when the births of deformed infants in Europe were linked to thalidomide ingestion by their mothers during pregnancy.^[7] Researchers discovered that the thalidomide crossed the placental barrier and caused serious birth defects in infants.^[5] She was hailed on the front page of The Washington Post as a heroine^[8] for averting a similar tragedy in the US.^[9] Morton Mintz, author of The Washington Post article, said "[Kelsey] prevented ... the birth of hundreds or indeed thousands of armless and legless children."^[8] The public outcry was swift and the Food, Drug, and Cosmetics Act Amendments of 1962 were passed unanimously by Congress.^[7] The drug testing reforms required "stricter limits on the testing and distribution of new drugs"^[5] to avoid similar problems. The amendments also, for the first time, recognized that "effectiveness [should be] required to be established prior to marketing."^[7]

As a result of her blocking American approval of thalidomide, Kelsey was awarded the President's Award for Distinguished Federal Civilian Service by President John F. Kennedy,^[10] becoming the second woman to receive that award.^[11]

Continued work at the FDA

  After receiving the award, Kelsey continued her work at the FDA. There she played a key role in shaping and enforcing the 1962 Amendments.^[9] She also became responsible for directing the surveillance of drug testing at the FDA.^[1] Kelsey finally retired from the FDA in 2005, at age 90, after 45 years of service.^[6]

In 2005, the FDA honored Kelsey by naming one of their annual awards after her. In announcing the awards, Center Director Steven K. Galson, M.D., MPH, said “I am very pleased to have established the Dr. Frances O. Kelsey Drug Safety Excellence Award and to recognize the first recipients for their outstanding accomplishments in this important aspect of drug regulation.”^[12]

Awards

• 1962 • President's Award for Distinguished Federal Civilian Service^[6]
• 1963 • Gold Key Award from University of Chicago, Medical and Biological Sciences Alumni Association^[13]
• 2000 • Inducted into the National Women's Hall of Fame^[11]
• 2001 • Named a Virtual Mentor for the American Medical Association^[14]
• 2006 • Foremother Award from the National Research Center for Women & Families [1]

Legacy

The Frances Kelsey Secondary School in Mill Bay, British Columbia is named in her honour.

See also

• Kefauver Harris Amendment
• Frances Kelsey Secondary School
• European Medicines Agency

References

• Barber, Jackie (2005-11-10). "Center ceremony honors 107 individuals, 47 groups: Spring event inaugurates Frances Kelsey Drug Safety Award". News Along the Pike. FDA/Center for Drug Evaluation and Research. Retrieved on 2006-09-12.
• Bren, Linda (March/April 2001). "Frances Oldham Kelsey: FDA Medical Reviewer Leaves Her Mark on History". FDA Consumer. Retrieved on 2006-04-30.
• ---. Dr. Frances Kathleen Oldham Kelsey. National Library of Medicine. Retrieved on 2006-04-30. Cited as "Library of Medicine biography".
• --- (1986). Frances Kelsey. Canada Heirloom Series. Heirloom Publishing Inc.. Retrieved on 2006-04-30. Cited as "Heirloom".
• Geraghty, Karen (July 2001). "Profile of a Role Model - Frances Oldham Kelsey, MD, PhD". Virtual Mentor - American Medical Association Journal of Ethics 7 (7). Retrieved on 2006-05-01.
• Kennedy, John F. (1962). Remarks Upon Presenting the President's Awards for Distinguished Federal Civilian Service. Retrieved on 2006-05-01.
• Mintz, Morton. "'Heroine' of FDA Keeps Bad Drug Off of Market", The Washington Post, 1962-07-15, p. Front Page. 
• Rouhi, Maureen (2005-06-20). "Top Pharmaceuticals: Thalidomide". Chemical & Engineering News 83 (25). American Chemical Society. Retrieved on 2006-04-30.
• Simpson, Joanne Cavanaugh (September 2001). "Pregnant Pause". Johns Hopkins Magazine 53 (4). Retrieved on 2006-04-30.
• Spiegel, Rachel. Research in the News: Thalidomide. Retrieved on 2006-04-30.
• --- (June 1981). "The Story Of The Laws Behind The Labels". FDA Consumer. Retrieved on 2006-04-30. Cited as "FDA Consumer".
• --- (2000). Women of the Hall - Frances Kathleen Oldham Kelsey, Ph.D., M.D.. National Women’s Hall of Fame. Retrieved on 2006-05-01. Cited as "Hall of Fame".