Thalidomide, a “wondrous”new drug from 1950s in Germany sold by Chemie Grunenthal under the brand name Contergan and initially developed as a tranquilizer was used to treat a variety of conditions such as cold, flu, nausea and most importantly morning sickness. Researchers from the company found it was impossible to give a lethal dose to animals. It was soon made by 14 companies in 46 countries and it seemed that thalidomide had its eyes set on the United States drug market.
Or that’s what they thought.
Frances Kathleen Oldham born in Cobble Hill, British Columbia, in Canada after graduating highschool at 15, attended Victoria College then enrolled at McGill University where she received both her Bachelors and Masters in science and encouraged by her professor to reach out to Eugene M.K. Geiling for a position in the University of Chicago’s new pharmacology department and thinking that she was a man, Geiling gave her the position. During her second year in, Frances observed how the loose drug regulation at the time needed to be worked on along with doing research on some drugs used and in 1938 the US Congress passed the Federal Food, Drug, and Cosmetic Act of 1938. After getting her Ph.D and MD, Frances met a fellow faculty member named Fremont Ellis Kelsey.
In 1960, Dr. Kelsey was hired by the FDA in Washington D.C. and her first assignment was to review of the Richardson-Merell’s application to sell thalidomide in the US and despite it being approved in Canada and many European and African countries already, Dr. Kelsey rejected the application citing that there wasn’t clear clinical testing and data. Since at the time the FDA could only withhold approval for 60 days, Dr. Kelsey continued requesting further information stating the testimonials that the RM sent didn’t have any scientific methodology and the authors weren’t credible. Additionally, Leslie Florence published a letter connecting thalidomide to neurological damage and Kelsey seeing this recalled her previous research to birth defects so she also requested that Richardson-Merell submit data that thalidomide wasn’t harmful to the fetus. However, Richardson-Merell instead sent false and misleading data to the FDA to speed up the approval process.
Then in November of 1961, babies born with deformities in Europe were linked to thalidomide being ingested by their mothers during pregnancy where researchers discovered that thalidomide could cross the placental barrier and cause serious birth defects. After, Richardson-Merell had distributed tablets to serve as an experiment causing seventeen malformed births, they withdrew their application. Dr. Kelsey was then celebrated as a national hero and credited for preventing hundreds or thousands of malformed children however Dr. Kelsey also insisted that her assistants and superiors also deserved credit. Due to her efforts, Dr. Kelsey was awarded the The President’s Award for Distinguished Federal Civilian Service and the Kefauver Harris Amendment was passed in Congress in October of 1962.
