Dr. Frances Oldham Kelsey and Her Fight Against the FDA

October 01, 2021

Written by: Alicen Ricard

It’s October again which means it Women’s History Month. This year we’re profiling a Canadian pioneer in the medical field, Dr. Frances Oldham Kelsey.

Source: National Post

She was born in 1914 in Cobble Hill British Columbia. She graduated from St. Margaret’s School at age fifteen. She then attended Victoria College (which is now UVIC) from 1930-1931. After that, she attended McGill University. When she was there she received both a B.Sc. and M.Sc. in pharmacology. She then did some graduate work at the University of Chicago, where she also earned a Ph.D. When she came to the University of Chicago for graduate work, the professor, Dr. Eugene Geiling, with whom she had been corresponding, thought she was a man because he thought women didn’t go into this field. 

In 1937 Geiling was recruited to figure out what was going on with the Elixir of Sulfanilamide. The drug had killed 107 people and Geiling and Kelsey were trying to figure out what in the drug was killing people. They solved it and it forced Congress to pass the Federal Food, Drug, and Cosmetic Act of 1938. This required drugs to be proven safe before they could be released. They still weren’t tested enough and wouldn’t be until the 1960s. 

Source: Smithsonian

She practiced medicine throughout the 1940s and 50s but it wasn’t until the 60s she would really come to be known.  She started working for the FDA in Washington, D.C. in 1960. Her main job was to review drugs. One of the drugs she was expected to review is Thalidomide. Thalidomide (also known as Kevadon) is a tranquillizer and pain killer that was prescribed to pregnant women for morning sickness. Dr. Kelsey didn’t want to approve the drug as she thought that a lot more research needed to be done on it. She wanted to make sure that taking the drug would be safe for the fetus. There was also a known case of peripheral neuitis, which is a nervous system side effect, a painful inflammation of the peripheral nerves. It affected roughly 100,000 infants

She was finally taken seriously after birth defects were found in babies whose mothers took Thalidomide during their pregnancy. Some of these deformities include the shortening or lack of limbs. The drug crossed the placental barrier and caused serious birth defects. Manufacturers were trying everything they could to make sure the drug was still released, but she fought hard against them with research. They claimed that the drug had no fatal dose and that it was safe. She had the power to make sure a drug wasn’t released if it wasn’t deemed safe. Dr. Helen Taussig saw birth defects in the child of one of her students and helped Dr. Kelsey get it rejected. Kelsey won an award for her work in making sure the drug wasn’t approved, the President's Award for Distinguished Federal Civilian Service from President John F. Kennedy. She was only the second woman to receive this award. 

She helped the FDA enforce amendments to the FDA drug regulations. She made sure there was plenty of research on all the drugs and that they were safe. 

Where else has Dr. Frances Kelsey come up? In Dr. Anne Simon, X-Files Science Advisor and Virologist's interview on our podcast, Best of the WWEST! Hear that episode here.