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Frances Oldham Kelsey

2007 Schools Wikipedia Selection. Related subjects: Human Scientists

            Frances Oldham Kelsey
         Born 24 June 1914
              Cobble Hill, British Columbia
   Occupation Physician, FDA
     Spouse   Fremont Ellis Kelsey

   Frances 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.

Birth and education

   Born Frances Kathleen Oldham in Cobble Hill on Vancouver Island,
   British Columbia. Kelsey graduated from high school at age 15, and
   enrolled at McGill University to study pharmacology. At McGill she
   received both a B.Sc.(1934) and a M.Sc.(1935) in pharmacology, 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. Despite Geiling
   assuming that Frances was a man, 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 sulfanilamide. Kelsey
   assisted on this research project, which verified that sulfonamide
   (diethylene glycol in Elixir Sulfanilamide) had caused 107 deaths
   (including many children). The next year, the United States Congress
   passed the Federal Food, Drug, and Cosmetic Act of 1938. That same year
   Kelsey successfully completed her studies and received a Ph.D. in
   pharmacology at the University of Chicago in 1938. Kelsey's work for
   Geiling is credited with her interest in teratogens, drugs that cause
   congenital malformations.

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 do pass through the placental barrier. While
   there she met and married, in 1943, fellow faculty member Dr. Fremont
   Ellis Kelsey.

   While on the faculty at the University of Chicago, Kelsey received an
   M.D. 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.

Work at the FDA and thalidomide

   Frances Kathleen Oldham Kelsey receiving the President's Award for
   Distinguished Federal Civilian Service from President John F. Kennedy,
   in 1962
   Enlarge
   Frances Kathleen Oldham Kelsey receiving the President's Award for
   Distinguished Federal Civilian Service from President John F. Kennedy,
   in 1962

   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" for the FDA. One of her first assignments
   at the FDA, was to review the drug thalidomide. She withheld approval
   for the drug , although it had already been approved in over 20
   European and African Countries, and requested further studies. Despite
   pressure from thalidomide's manufacturer, Kelsey persisted in
   requesting additional information to explain an English study which
   documented a nervous system side effect.

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

   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, becoming the second
   woman to receive that award.

Continued work at the FDA

   Dr. Kelsey (age 87) at the FDA Reception commemorating her induction
   into the National Women's Hall of Fame
   Enlarge
   Dr. Kelsey (age 87) at the FDA Reception commemorating her induction
   into the National Women's Hall of Fame

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

   In 2005, the FDA honored Kelsey by naming one of their annual awards
   after her. In announcing the awards, Centre 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.”

Awards

     * 1962 • President's Award for Distinguished Federal Civilian Service
     * 1963 • Gold Key Award from University of Chicago, Medical and
       Biological Sciences Alumni Association
     * 2000 • Inducted into the National Women's Hall of Fame
     * 2001 • Named a Virtual Mentor for the American Medical Association

Legacy

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

   Retrieved from " http://en.wikipedia.org/wiki/Frances_Oldham_Kelsey"
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   with only minor checks and changes (see www.wikipedia.org for details
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