March 17, 1962: Dr. Frances Kelsey, the Hero You've Never Heard Of

Dr. Kelsey, honored by President Kennedy

You've heard Billy Joel's song "We Didn't Start the Fire." Most of it is chronologically accurate. One line that's a bit out of place is the mention of "children of thalidomide," placed in the sequence at 1958. Certainly, it was an issue at the time, more so in Europe than in America.

But it would take another 4 years to resolve the issue. And while you've heard the line in the song, you probably haven't heard of the hero who helped to resolve it. And that's because, in those days, the women who affected the history of science were often written out of that history. DNA co-discoverer Rosalind Franklin. The "Hidden Figures" mathematicians who made the space program possible, who also had the disadvantage of being black: Katherine Goble Johnson, Dorothy Vaughan and Mary Jackson. Computer pioneer Grace Hopper. Actress Hedy Lamarr, who invented military tech that led to the development of Wi-Fi. And Frances Kelsey.

March 17, 1962: Pharmaceutical company Richardson-Merrell withdraws their application to the U.S. Food & Drug Administration (FDA) to market the drug thalidomide. It was an effort led by Dr. Frances Oldham Kelsey.

Frances Kathleen Oldham was born on July 24, 1914 in Cobble Hill, British Columbia, Canada. She attended what's now the University of Victoria, in Victoria, the capital of British Columbia; then earned her Bachelor's and Master's degrees in pharmacology from McGill University in Montreal. She went work at the University of Chicago, got her Ph.D. and her M.D. there, married a colleague, Fremont Ellis Kelsey, and began her study of drugs causing birth defects when taken by pregnant women.

She and her husband had 2 daughters -- fortunately, without birth defects -- and in 1954, they moved to Vermillion, South Dakota, where they taught at the University of South Dakota. In 1960, she was hired by the FDA in Washington, D.C. At that time, she "was one of only seven full-time and four young part-time physicians reviewing drugs" for the FDA.

One of her first assignments at the FDA was to review an application by Richardson-Merrell for the drug thalidomide, under the tradename Kevadon, as a tranquilizer and painkiller, with specific indications to prescribe the drug to pregnant women for morning sickness.

Although it had been previously approved in Canada and more than 20 European and African countries, she withheld approval for the drug, and requested to see clinical trial information. At the time, the FDA could only withhold approval for 60 days at a time, so she continually requested further information from the company every 60 days for over a year. Her initial reason for doing this was that the testimonials supplied by Richardson-Merrell contained no scientific methodology, and she recognized their authors as having published suspicious articles in the past.

In December 1960, a Scottish doctor named Alexander Leslie Florence published a letter in the British Medical Journal, connecting thalidomide to neurological symptoms. Kelsey saw this letter, and added Florence's observed symptoms to her ongoing data requests. The unexpected neurological effects caused her to recall her earlier work on the mechanism of birth defects, so she also requested animal studies to demonstrate that the drug would not be harmful to the fetus.

In fact, Richardson-Merrell had reportedly discovered birth defects when the drug was tested on rats, but did not report this finding; Kelsey was instead sent misleading partial data suggesting the product was safe for pregnant women. Despite the fact that thalidomide was already widely used in Europe and elsewhere, Kelsey remained suspicious, and scrutinized this data with concern and skepticism. Her superiors at the FDA stood by her.

Kelsey's insistence that the drug should be fully tested prior to approval was vindicated in November 1961, when the births of deformed infants in Europe were linked to thalidomide ingestion by their mothers during pregnancy. On March 17, 1962, after distributing "experimental" tablets to tens of thousands of patients without approval, causing 17 malformed births, Richardson-Merrell at last withdrew their FDA application.

Kelsey was hailed on the front page of The Washington Post as a heroine, for averting a large-scale tragedy in the U.S. Morton Mintz, author of the Post article, said "[Kelsey] prevented... the birth of hundreds or indeed thousands of armless and legless children." Kelsey insisted that her assistants, Oyama Jiro and Lee Geismar, as well as her FDA superiors who backed her strong stance, deserved credit as well.

On August 7, President John F. Kennedy awarded her the President's Award for Distinguished Federal Civilian Service. On October 10, JFK signed into law the Kefauver-Harris Amendment, sponsored by Senators Estes Kefauver of Tennessee and Fred Harris of Oklahoma. This amendment to the Federal Food, Drug and Cosmetic Act of 1938 requires drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval, requires drug advertising to disclose accurate information about side effects, and stops cheap generic drugs being marketed as expensive drugs under new trade names as new "breakthrough" medications.

(So if you have moderate-to-severe commercial annoyance, caused by constant TV commercials for various prescription drugs, whose listing of side effects is longer than their listing of benefits, blame, JFK, Kefauver, Harris and Dr. Kelsey. As annoying as these ads are, it's still better to have them than not.)

Kelsey remained at the FDA until retiring at age 90 in 2005. In 2010, the FDA created the Dr. Frances O. Kelsey Award for Excellence and Courage in Protecting Public Health, and made her the 1st honoree.

She died on August 7, 2015, at the age of 101, in London, Ontario, where she had moved to be close to her daughter. She died just 1 day after being presented with the Order of Canada, her birth nation's highest honor, by Elizabeth Dowdeswell, then the Lieutenant-Governor of the Province of Ontario.

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March 17, 1962 was a Saturday. Kalpana Chawla was born. She was the 1st native of India to fly in space, but was killed in the Space Shuttle Columbia disaster in 2003.

This was also the day that Ray Charles released his landmark album Modern Sounds in County & Western Music. I have a separate entry for that event.

Baseball was in Spring Training. Football was out of season. There was 1 game played in the NBA: The Cincinnati Royals beat the Detroit Pistons, 129-107 at the Cincinnati Gardens. Oscar Robertson scored 33 points.

There were 2 games played in the NHL. The Montreal Canadiens beat the New York Rangers, 2-0 at the Montreal Forum. And the Chicago Black Hawks beat the Toronto Maple Leafs, 3-1 at Maple Leaf Gardens in Toronto. The Boston Bruins and the Detroit Red Wings were not scheduled.

And in English soccer, Arsenal and Cardiff City played to a 1-1 draw at the Arsenal Stadium, a.k.a. Highbury, in North London.