Photo courtesy of Drew Hays, Unsplash

The reader’s comment on a story about Frances Kelsey was disparaging. It questioned why Mrs. Kelsey should be singled out as a heroine when she was “just doing her job.”

Well, her job was this: She was a medical officer at the Food and Drug Administration in 1960. She’d had the position just one month when the drug company William S. Merrell submitted an application for approval of a drug from Germany.

The drug’s American trade name was Kevadon; it was already being sold in two dozen other countries and Merrell was pushing for quick approval. After all, it was just a mild sedative that helped pregnant women overcome morning sickness.

The FDA procedure at the time was a three-prong approach. A proposed new drug was studied by a chemist, a pharmacologist, and a medical officer. Back then, a drug would be automatically approved if none of the three filed an objection within 60 days.

Frances Kelsey, the medical officer assigned to the Kevadon application, was well suited for the task.

She had studied biology, biochemistry, and pharmacology (the branch of medicine dealing with the uses and effects of drugs). A Canadian, she earned her Master’s from McGill University in Montreal. In 1938 Frances was awarded her Ph.D. in pharmacology.

One of her jobs was verifying the scientific accuracy of articles submitted to the Journal of the American Medical Association. She began connecting threads—there were a handful of doctors who wrote articles that were not scientifically accurate.

Later in 1960 as she began her work evaluating the medical aspects and supporting material of Kevadon, she came across some of those SAME questionable doctors. They had submitted support for the drug’s claims. But their papers read more like infomercials instead of scientific studies.

Mrs. Kelsey and her two team members (who had also found problems in their areas of expertise), denied the drug’s approval until (and if) better testing, studies, and evidence were provided. The drug company grew increasingly impatient as weeks stretched into months. They complained to Mrs. Kelsey’s supervisors and hounded her relentlessly by phone and mail.

Frances Kelsey stood firm. Kevadon was never approved in the United States.

The drug, which was generically named thalidomide, caused over 10,000 birth defects in 46 countries before it was removed from the market in 1961. Merrell withdrew their application.

John F. Kennedy presented Frances with the President’s Award for Distinguished Federal Civilian Service in 1962. Her steadfastness and determination to do what was right prompted legislation which strengthened drug regulation.

Think for just a moment about this: A woman medical officer stood up to a drug company in 1960.

She must have been an amazing, brilliant, and courageous woman. What a role model.

Just doing her job?  I don’t think so.