Dr. Frances Kelsey: “Just Stick to Your Guns”

In Europe and Canada, the sedative thalidomide was routinely given to pregnant women, resulting in children being born with severe birth defects such as missing limbs. The United States, however, did not approve the drug and kept it off store shelves, as a result of the efforts of Canadian-born Dr. Frances Kelsey, who worked for the United States Food and Drug Administration. Her advice to people in similar situations is this: “Just stick to your guns.” She said, “I just held my ground. I wouldn’t approve it.” Over 100 children in Canada suffered severe birth defects because of thalidomide. Mercédes Benegbi, head of The Thalidomide Victims Association of Canada, said, “She was an example of rigour. It’s as if we were wimps in Canada. On the basis of the same data, we said everything was perfect, while it was unacceptable in the U.S. Someone here didn’t do their job.” After receiving her undergraduate and masters degrees in science at McGill University in Montreal, Ms. Kelsey applied for a job as a research assistant at the University of Chicago, and she received an acceptance letter that addressed her as “Mr.” She said, “To this day, I do not know if my name had been Elizabeth or Mary Jane, whether I would have gotten that first big step up.” She got a medical degree, worked for a while at the American Medical Association Journal, and took a job at the FDA in Washington D.C. In 1960, after she had been working at the FDA for only a month, she was given the task of deciding whether or not to approve thalidomide, which had been used in Europe for years and was made by U.S. drug-maker William S. Merrell Co. of Cincinnati, for use in the U.S. Dr. Kelsey said, “They figured it was so popular in Europe, so I would be a pushover.” But information about the safety of the drug was lacking. She said, “The information as presented was very sketchy.” She added, “The company wasn’t happy with me. They thought I was being pretty stubborn. They just wanted to sell their drug.” Representatives of the drug company kept trying to persuade her to approve the drug. She said, “I just didn’t like it from the start. It was just too overblown. And they didn’t have any evidence to submit. They were so sure it was good because of its popularity in England. They couldn’t understand what I was fussing about.” She did not approve the drug, and soon reports of birth defects linked to the drug began coming from Europe, and European countries began to ban the drug. In 1962, President John F. Kennedy gave her an award. She said, “It was a lovely day, and he was very handsome.” In 2010, the FDA named a prize after her. President Barack Obama also sent this message to her: “Our country relies on dedicated public servants like Dr. Kelsey to create a better, healthier future for our children and grandchildren.” Best of all, she kept many children from being born without severe birth defects.

For More Information: Ingrid Peritz, “Canadian doctor averted disaster by keeping thalidomide out of the U.S.” The Globe and Mail (Toronto, Ontario, Canada). 24 November 2014

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