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Dr. Frances Oldham Kelsey was a physician and pharmacologist from Canada. She emigrated to the United States, where she worked for the Food and Drug Administration (FDA). She refused to accept the application from the William S. Merrell Company to distribute thalidomide due to her suspicions about the drug’s dangers. Thousands of cases of birth defects across the world proved her concerns to be correct and the U.S. placed the FDA in control of regulating pharmaceuticals.

Childhood and Early Education

Frances Oldham was born on July 24, 1914, in Cobble Hill, Vancouver Island, British Columbia, Canada. Her parents were Frank Oldham and Katherine Stuart Oldham and she was one of three children.[1] Frank served as a soldier in the British army and he moved to Canada with his family after retiring. The Oldham family did not own a car until Frances was nine years old, but used a horse and buggy.

Frances learned to read and write by watching her mother teach her older brother. The family traveled between Canada and England during her youth and she attended several different schools. Oldham first studied at the all-boys Leinster Preparatory School, where she learned French, Latin, composition, math, and chemistry. She then learned privately under Marjorie Gillette before finishing 8th grade and high school in Victoria, Canada.

Biology Research

The summer before Oldham’s senior year, she met young Dr. Anthony Kingscote, a professor of biology at Ontario College of Agriculture who introduced her to the subject. She enrolled at Victoria College the same year and Bachelor of Science degree.[2] Oldham received a Master’s in Science degree a year later in 1935.[3]

Frances Oldham did not know anything about biology prior to high school, but always felt drawn to the subject.

Frances Oldham Kelsey continued her academic pursuits at the University of Chicago, Illinois, researching the posterior pituitary gland with Dr. Eugene Geiling in March 1936. She focused on the glands of adult armadillos and received a Ph.D. in 1938.[4] Oldham assisted Dr. Geiling to discover the reason Elixir Sulfanilamide, a drinkable antibacterial powder, suddenly became toxic after adding artificial color and flavoring to make it more palatable in 1937. They discovered the solvent, diethylene glycol, mixed with it to be the cause and the following year the Federal Food, Drug, and Cosmetic Act of 1938 passed requiring demonstrated safety of a pharmaceutical drug prior to market.

Career Beginnings and Family

Dr. Frances Oldham joined the faculty at the University of Chicago after graduating, where she met Dr. Fremont Ellis Kelsey.[5] He had a doctorate in biochemistry and the pair married in 1943. In 1946, Dr. Frances Kelsey enrolled in the University of Chicago’s Medical School with six other women making up 10% of the class.[6] She bore two daughters before graduating in 1950, Christine and Susan.

The Journal of the American Medical Association hired Dr. Frances Kelsey as an editorial associate to review articles for publication for two years. The Kelsey’s then moved to Vermillion, South Dakota when the University of South Dakota’s Medical School asked Dr. Ellis Kelsey to be Chairman of the Physiology and Pharmacology Department. Dr. Frances Kelsey taught pharmacology at the university while running a private medical practice. In 1956, she received her U.S. citizenship.[7]

The Food and Drug Administration

In 1960, the Kelsey family moved to Washington, D.C. and Dr. Frances Oldham Kelsey was hired by the FDA to review licensing applications for new drugs from pharmaceutical companies. The first application came in September 1960 from Ohio’s William S. Merrell Company. Merrell requested permission to sell a sleeping pill containing thalidomide, a new drug created in West Germany and sold in several countries for the previous three years. He also wanted to market it as an anti-nausea medicine for pregnant women as it became more popular with physicians.

Since the Food and Drug Administration only just began evaluating drugs for distribution in the United States, Dr. Frances Kelsey needed to figure out the necessary drug safety evidence with her own team.

Dr. Frances Kelsey did not approve the request and asked for further studies to be done since she did not feel the evidence to be sufficient. Merrell was eager to get approval, but Dr. Kelsey did not rush. The British Medical Journal published a study in February 1961 linking long-term thalidomide ingestion to numbness in the legs and arms. Three months later, Dr. Kelsey informed the Merrell company that the drug might affect fetal development and they dismissed it.[8]

Thalidomide Danger

European doctors first reported serious malformations occurring in the appendages of newborn babies called phocomelia only six months afterward. As more malformed infants were born, the Merrell company canceled their application. The FDA discovered 17 children in the U.S. to be affected by the thalidomide, while tens of thousands of European babies suffered fatal birth defects.[9]

On July 15, 1962, the Washington Post ran a story titled “Heroine' of FDA Keeps Bad Drug Off of Market” that informed the public of Dr. Frances Oldham Kelsey’s role in preventing thalidomide from entering the U.S. market.[10] She quickly became famous, but always insisted Lee Geismar, her chemist, and Oyam Jiro, her pharmacologist, receive due credit as well.[11]

Congress revived a bill known as the Kefauver-Harris Amendments which President John F. Kennedy signed into law on October 10, 1962. This strengthened the Act passed in 1938 and gave the FDA more control to regulate the approval and distribution of new drugs as well as human experimentation. President Kennedy awarded Dr. Kelsey the President's Award for Distinguished Federal Civilian Service as well.[12]

Later Life and Death

Dr. Frances Kelsey continued to work at the FDA until her retirement in 2005.[13] The National Women’s Hall of Fame inducted her in 2000 and, in 2010, the FDA honored her with the first annual Dr. Frances O. Kelsey Drug Safety Excellence Award.[14]

Dr. Kelsey lived with her daughter in London, Ontario during her last years. Only a day before her death, she participated in a private induction ceremony into the Order of Canada at her daughter’s home. Dr. Frances Oldham Kelsey died on August 7, 2015, at home and was buried in Cherry Hill Cemetery next to her husband in Sugar Grove, Pennsylvania.[15]

References

Bibliography

Bren, L. (2001, March). Frances Oldham Kelsey: FDA Medical Reviewer Leaves Her Mark on History. FDA Consumer Magazine.[1]

Find A Grave. (2015, August 9). Dr Frances Kathleen Oldham Kelsey. Find A Grave Memorial.[2]


Kelsey, M.D., Ph.D., F. O. (2004). Autobiographical Reflections. FDA.[3]


McFadden, R. D. (2015, October 17). Frances Oldham Kelsey, Who Saved U.S. Babies from Thalidomide, Dies at 101. The New York Times.[4]

Footnotes

  1. McFadden, 2015
  2. Kelsey, M.D., Ph.D., 2004
  3. McFadden, 2015
  4. Kelsey, M.D., Ph.D., 2004
  5. Bren, 2001
  6. Kelsey, M.D., Ph.D., 2004
  7. McFadden, 2015
  8. McFadden, 2015
  9. McFadden, 2015
  10. Bren, 2001
  11. McFadden, 2015
  12. Bren, 2001
  13. Find A Grave, 2015
  14. McFadden, 2015
  15. Find A Grave, 2015

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