a biography of the day--frances oldham kelsey-- (who kept thalidomide off the american market)

Frances Oldham Kelsey


Frances Kathleen Oldham Kelsey, Ph.D., M.D., (born 24 July 1914) is a 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 serious birth defects. Kelsey's career intersected with the passage of laws strengthening the FDA's oversight of pharmaceuticals.


Born Frances Kathleen Oldham in Cobble Hill on Vancouver Island, British Columbia,[1] Kelsey graduated from high school at age 15,[2] and attended Victoria College, British Columbia (1930-1931) in Victoria, British Columbia (now University of Victoria). She then 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] Geiling assumed that Frances was a man, but Frances accepted the position rather than clarifying her gender first,[3] and began working for Geiling in 1936. 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]


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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 application by Richardson Merrell for the drug thalidomide (under the tradename Kevadon) as a tranquiliser and painkiller with specific indications to prescribe the drug to pregnant women for morning sickness. Even though it had already been approved in Canada and 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 that 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 drug testing reforms were passed unanimously by Congress a few months later.[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]

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In 2010, the FDA named the Kelsey Award for her, to be awarded to an FDA employee.[12


http://en.wikipedia.org/wiki/Frances_Oldham_Kelsey