Thalidomide & Frances Oldham Kelsey

Frances Kelsey Behind Microphones

Dr. Frances Kelsey, the Food and Drug Administration medical officer who kept Thalidomide off the American market, is shown as she appeared before a Senate government operations subcommittee. The senators called Dr. Kelsey to ask her about pressures she withstood before the drug was proved dangerous. August 01, 1962

 

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.[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.  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 — that is, 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 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

1962: Frances Kathleen Oldham Kelsey receiving the President’s Award for Distinguished Federal Civilian Service from President John F. Kennedy

 

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 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]

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]

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]

Legacy and awards

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

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.”

  • 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
  • 2006 • Foremother Award from the NRC for Women & Families

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

From Wikipedia, the free encyclopedia

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One thought on “Thalidomide & Frances Oldham Kelsey

  1. Question your Indoctrination as well as your Doctor.
    We must continue to take into account that Medical Science + Regulators are NOT infallible. I hear far too many people dismissing my queries about their respective ‘issues’, due to their “doctor already saying it was okay.”

    From smoking while pregnant (the doctor told it would be worse if i quit) to drinking green tea while pregnant (the doctor said there is no caffeine in it)…..
    People must realize doctors are merely humanoid body mechanics. there is A GREAT DEAL of guessing and testing going on.

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