Frances Oldham Kersey saves America from Thalidomide

[valley ranch]

Frances Oldham Kelsey
Source: http://en.wikipedia.org/wiki/Frances_Oldham_Kelsey
Updated: 2015-05-03T09:57Z
Frances Oldham Kelsey

Born 24 July 1914 (age 100)
Shawnigan Lake, British Columbia
Occupation Physician, FDA employee
Known for preventing thalidomide from coming to market in the United States
Spouse(s) Fremont Ellis 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.

Contents

• 1Birth and education
• 2Early career and marriage
• 3Work at the FDA and thalidomide
• 4Legacy and awards
• 5See also
• 6References
• 7Further reading
  Birth and education
  Born in [URL='http://us.wow.com/wiki/Shawnigan_Lake']Shawnigan Lake on Vancouver Island, British Columbia,[1] Oldham 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 and offered her the position. Oldham accepted[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 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
  
  1962: Frances Kathleen Oldham Kelsey receiving the President's Award for Distinguished Federal Civilian Service from President John F. Kennedy
  
  Kelsey (age 87) at the FDA Reception commemorating her induction into the National Women's Hall of Fame
  Upon completing her Ph.D., Oldham 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, Oldham 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, 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
  
  Kelsey in the 1960s
  In 1960 Kelsey was hired by the FDA in Washington, D.C.. 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 tranquilizer 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 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]
  
  After Morton Mintz broke the story in July 1962, there was a substantial public outcry. The Kefauver Harris Amendment was passed unanimously by Congress in October 1962 to strengthen drug regulation.[7] Companies were required to demonstrate the effectiveness of new drugs, report adverse reactions to the FDA, and request consent from patients participating in clinical studies.[10] 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,[11] becoming the second woman to receive that award.[12] British Pathé released a film of Kennedy acknowledging Kelsey in a speech.[13] 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 retired from the FDA in 2005, at age 90, after 45 years of service.[6] In 2010 the FDA named the Kelsey Award for her, to be awarded to an FDA employee.[14]
  
  Legacy and awards[/URL]
• 
  the drug detective
  
  • 1962 • President's Award for Distinguished Federal Civilian Service[6]
  • 1963 • Gold Key Award from University of Chicago, Medical and Biological Sciences Alumni Association[15]
  • In 1994, the Frances Kelsey Secondary School in Mill Bay, British Columbia is named in her honour.[16]
  • 2000 • Inducted into the National Women's Hall of Fame[12]
  • 2001 • Named a Virtual Mentor for the American Medical Association[17]
  • 2006 • Foremother Award from the NRC for Women & Families [18]
  • In 2010 the FDA honored Kelsey by naming one of their annual awards after her, the FDA Kelsey Award.[19] 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.”[20] Kelsey received the first Kelsey Award which will be given to one FDA staff member annually.[21]
  • Kelsey received an honorary doctor of science degree from Vancouver Island University in June 2012.[22]
  • Kelsey turned 100 in July 2014.[23]

 

[dickiebird]

AWW GEEZ not this stuff again!!!!

THANX RICH

 

[ninnymary]

Good one dickiebird! Got a chuckle.

Mary

 

[valley ranch]

Dickie, Did you read it? Every country that Thalidomide was sold in had birth defects EXCEPT America, Thanks to this lady.

 

[dickiebird]

I really don't care, this stuff was from back in the '50's or 60's and has nothing to do with gardening, except maybe in your mind!!!!

THANX RICH

 

[valley ranch]

Ok, Dickie,