I first learned about Canadian scientist/physician Frances Oldham Kelsey when I read about her death in 2015, which is actually, kinda sad. But not nearly as sad as things could have been in the United States had she not raised her fist in the air and declared, “As God is my witness…thalidomide will never be approved for use in the United States.” While that’s not EXACTLY how this went down, the results were pretty much just as dramatic! The drug thalidomide, which was widely prescribed to pregnant women suffering sleeplessness/morning sickness in West Germany beginning in 1957, caused deformities including missing/deformed limbs in 5,000-7,000 infants. A derogatory term used to describe these babies was “flipper babies.” Only about 40 percent of these deformed babies survived. No, I’m not providing any images of those babies in this blog, go to google images if you’re really curious! Though the drug is still used today (primarily to treat some cancers), all prescribing physicians must use caution when prescribing to women of child-bearing ages and ensure contraception is being used.

Frances Oldham Kelsey with President John F. Kennedy in 1962

Frances Oldham was born  in 1914, on Vancouver Island, British Columbia. She earned both of her undergraduate degrees in science from McGill University, Montreal, in 1934 and 1935.

As a graduate student at the University of Chicago, she began her pharmacology studies in earnest. She worked assisting noted medical researcher EMK Geiling, M.D., whom was starting up a new pharmacology department at the University of Chicago. She began working with him in 1936. She assisted in Geiling’s research into elixir sulfanilamide, which reportedly caused 107 deaths because of diethylene glycol, which was used as a solvent. Small amounts of diethylene glycol can be found in antifreeze, and this substance has been used in the intentional poisonings of others (I’ve watched WAY too many true crime shows, lol).

In 1938, the U.S. Congress established the Federal Food, Drug and Cosmetic Act, which will end up being a key plot point in this female physician’s life!

In 1938, she earned her Ph.D. from the University of Chicago, and went on to teach there from 1938 to 1950. Dr. Frances Oldham married Dr. Fremont Ellis Kelsey, a fellow faculty member at University of Chicago, in 1943. Their two daughters were born while she earned her medical degree at the University of Chicago Medical School.

So I’ve established that Ms.  Kelsey was… a pretty damn smart woman! She began what would become a long career at the Food and Drug Administration in 1960, and her first task was to review a drug that was widely used as a sleeping pill in Europe – and that drug was thalidomide. Upon reading reports of widespread birth defects connected to thalidomide in Europe, Kelsey was skeptical about giving a “thumbs-up” to this drug, so she wanted to learn more. A fellow female physician, Dr. Helen Taussig, had heard about the birth defects in Europe and traveled there to investigate. She would eventually testify before the U.S. Senate and help Kelsey get the drug banned in the United States. As you can imagine, though, it didn’t happen nearly as easily as this! The drug maker Richardson-Merrell tried everything they could to help get the drug on the market – and requested approval a total of SIX times. Some thalidomide actually did make its way into the bodies of some people in the United States for “testing purposes.” But  Kelsey held her ground, and the drug was not approved for use in the United States, though a total of 17 “thalidomide babies” were estimated to have been born here. That is nothing compared to the thousands of deformed babies who were born in West Germany (side note, East Germany never approved thalidomide’s use).

 

Dr. Helen Taussig, circa 1940

On August 7, 1962, President John F. Kennedy awarded Frances Kelsey the highest honor given to a civilian in the United States, which was the President’s Award for Distinguished Federal Civilian Service. She was the second woman to ever receive the award. I did attempt to find out who the first woman was to receive this award, but as of this blog’s posting, it was to no avail! I will assume she was probably pretty awesome, whomever she was!  Upon presenting this award to Kelsey, Kennedy said, “Her exceptional judgment in evaluating a new drug for safety for human use has prevented a major tragedy of birth deformities in the United States. Through high ability and steadfast confidence in her professional decision she has made an outstanding contribution to the protection of the health of the American people.” Read more about this here

Kelsey lived to the age of 100, and before her death,  she was named to the Order of Canada, by Mercédes Benegbi, a thalidomide victim and the head of the Thalidomide Victims Association of Canada. Benegbi said, “To us, she was always our heroine, even if what she did was in another country.” Kelsey was a dual citizen of both the United States and Canada throughout most of her life.

Fast forward to 2018…TV viewers are hard-pressed to go an hour without seeing a flashy drug advertisement. It’s always amusing when they prompt you as such, “Please see our ad in Golf Digest.” All righty! I’ll just run to the nearest newsstand right now so I can buy a Golf Digest! I must know more about this drug…like, right now! I view all of these ads with skepticism. I can’t help but wonder if months or years down the road I’ll also see advertisements by law firms greedy to aid former users of that same drug in class-action lawsuits. The former users that didn’t die from horrific side effects, that is…