WoW Blog (Woman of the Week) Blog

WoW Blog (Woman of the Week)

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Frances Oldham Kelsey (Born June 24, 1914)

Posted January 15, 2008 6:00 AM by Sharkles

Frances Kathleen Oldham Kelsey, Ph.D., M.D., is a pharmacologist who is famous for her diligence in evaluating the drug Thalidomide, while a physician at the FDA. The drug was withheld FDA approval based on her recommendations and was later found to cause birth defects.

Frances Kathleen Oldham was born on Vancouver Island in British Columbia on June 24, 1914. Oldham graduated from high school at 15 and enrolled at McGill University where she would receive both a Bachelors (1934) and Masters (1935) of Science in pharmacology. In 1938, she earned her Ph.D. in Pharmacology from the University of Chicago where she later taught from 1938 to 1950. During this period Dr. Frances Oldham married Dr. Fremont Ellis Kelsey, a faculty member at the University of Chicago (becoming Dr. Frances Kelsey) and had two daughters. Also, it was during this time that Dr. Frances attended the University of Chicago's Medical School and received her M.D.(1950). She interned at Sacred Heart Hospital in Yankton, South Dakota and from 1954 to 1957 was an associate professor of pharmacology at the University of South Dakota. In 1955 she became a nationalized citizen, and from 1957 to 1960 she ran a private practice in South Dakota.

While working at the University of Chicago, Dr. Frances Kelsey published several papers on antimalarial drugs. At the time there was a push for a synthetic cure for malaria, which was ravaging WWII soldiers, and Dr. Frances Kelsey and her husband worked on this problem. It was during this research, that she observed that some of the prospective drugs could pass through the placenta wall in pregnant rabbits. This was significant because although the adult rabbit's liver could break down the antimalarial drugs, the fetal liver of the embryonic rabbit could not. This knowledge was to play a crucial role later in her life.

In 1960 Dr. Kelsey moved to Washington D.C. and became a medical officer for the Food and Drug Administration. One of her first assignments at the FDA was to review a drug called Thalidomide. Thalidomide, a sedative for pregnant women to assist with morning sickness and as a sleep aid, had already been approved in over 50 European and African countries. In early 1961, while reviewing the drug, Dr. Kelsey read a letter in the British Medical Journal suggesting an association between Thalidomide and peripheral neuritis (tingling in arms and legs). Dr. Kelsey requested additional studies from Richardson-Merrill, the distributor of thalidomide, before American approval could be granted. At first, Richardson-Merrill complied with the request for additional information; however, the additional information failed to assuage Dr. Kelsey's concerns. The company, growing anxious with the delay to its entry in the large American market, complained to her superiors. Despite the pressure, Dr. Kelsey held firm; additional studies would be required for American approval. Later, as the first reports connecting Thalidomide and birth defects began to emerge from Europe, Dr. Kelsey remembering her earlier antimalarial work and dug in against approval.

Thalidomide had been on the market since 1957 in Europe, during which time there had been a growing number of birth defects such as short limbs, malformed organs, and miscarriages. In November 1961, a German pediatrician named Widukind Lenz determined the cause of the birth defects was Thalidomide. Ten days later, German health authorities pulled the drug from the market and other countries followed its lead. By March 1962, Richardson-Merrill withdrew its application from the FDA. It was later estimated that more than 10,000 children in 46 countries were born with deformities as a consequence of thalidomide use. The damage in the US was very small, since the drug never received approval; a disaster had been averted due to Dr. Kelsey.

The fallout of the disaster resulted in the passing of the Food, Drug, and Cosmetics Act Amendments of 1962, which required stricter limits on the testing and distribution of new drugs. Dr. Kelsey received the President's Award for Distinguished Federal Civilian Service from John F. Kennedy. Dr. Kelsey continued her work at the FDA where she played a key role in shaping and enforcing the 1962 Amendments for the next 43 years. In 2005, Dr. Kelsey retired from the FDA at the age of 90 and was honored by the FDA by naming an annual award after her, the Dr. Frances O. Kelsey Drug Safety Excellence Award.

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Re: Frances Oldham Kelsey (Born June 24, 1914)

01/18/2008 6:41 AM

Hello Sharkles

I had two friends who were "thalidomide babies", one with no arms, the other with a single tiny arm.

Life was difficult for them both.

What intrigued me with the story, was the <"She interned at Scared Heart Hospital in Yankton,.....">

Bad hearts I have heard of, but a Scared Heart?

A proofreader is better than a spell chequer.

Kind Regards....

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"The number of inventions increases faster than the need for them at the time" - SparkY
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