Frances Kelsey
Invalidating Thalidomide for Prenatal Use

In August 1962, Canadian-born Dr. Frances O. Kelsey attended a White House ceremony to receive the highest honour given to a civilian in the United States. It was the President’s Award for Distinguished Federal Civilian Service, the medal presented by President John F. Kennedy to the then 41-year-old member of the Food and Drug Administration. She was cited for resisting the sale of the drug thalidomide in the United States, thereby preventing the birth of thousands of deformed babies in the United States as happened in Germany, Great Britain, Canada, and numerous other countries in the late 1950s and early ’60s.

Born in 1914 at Cobble Hill, Vancouver Island, Frances Oldham, daughter of a retired British Army officer, received a B.Sc. and M.Sc. at McGill University in 1935 before receiving a Ph.D. in pharmacology at the University of Chicago. She then joined the faculty where she met and married another faculty member, Dr. Fremont Ellis Kelsey. In 1950, she added an M.D. to her achievements, worked as an editorial associate of the American Medical Association Journal for two years, and then moved with her husband and two daughters to Vermillion, South Dakota.

Between 1954 and 1957 she taught pharmacology at the University of South Dakota. She then practised medicine by serving as a temporary doctor in a number of small communities throughout the state, becoming, in the words of Senator Karl Mundt, “physician and friend to over 50,000 South Dakota residents” before her husband accepted a post in Washington in 1960. In Washington, she was hired by the Food and Drug Administration to evaluate applications of pharmaceutical firms for a licence to market new drugs.

Her first assignment, in September 1960, was to consider an application from William S. Merrell Company of Cincinnati, Ohio, requesting approval of thalidomide as a new type of sleeping pill that had been initially developed in West Germany in the early 1950s and sold under various trade names in a number of countries since 1957. Merrell wished to market his product as Kevadon and expected almost routine approval, but Dr. Kelsey wasn’t quite satisfied with his company’s research. She noticed that the drug didn’t put animals to sleep and that it reacted differently than other drugs it chemically resembled. She therefore requested further studies on the drug.

Although the company initially complied, it eventually appealed to her superiors. Dr. Kelsey continued to resist, pointing out in February 1961 that a study in England had indicated the new product caused “a serious side effect on the nervous systems of patients who took the drug repeatedly,” so she asked for assurances that such side effects wouldn’t occur. By May she had developed a theory that if thalidomide caused paralysis of the peripheral nerves, the drug probably would cause greater damage to the developing embryo. Despite this, according to a 1962 report read into the Congressional Record by Senator Estes Kefauver, the company continued to seek product approval by appealing to her superiors.

In late September 1961, Merrell asked if they could go ahead with the labelling so that they could have the drug on the market by Christmas, but again Dr. Kelsey refused. She was vindicated in late November when a German scientist, Dr. Widukind Lenz, reported there was evidence to suggest that the epidemic in his country of phocomelia, “a malformation of limbs in new-born babies was caused by a drug that he believed to be thalidomide.” Merrell withdrew its application and, in March 1962, withdrew the drug from experimental use that, under the laws then in effect, was allowed while approval for marketing was being sought.

As a result, only a very few babies in the United States were affected: nothing compared with Germany where, according to reports, a possible 3,500 to 5,000 were affected, or Great Britain where at least 1,000 deformed births were attributed to the drug. The number of Canadian mothers giving birth to thalidomide children is estimated to be 115.

As a result of her work, Dr. Kelsey was suddenly showered with publicity in such leading newspapers as the New York Times and Washington Post, Life and Reader’s Digest magazines, and scientific journals that praised her stubborn resistance to being bullied into giving her approval. Even more effective were the two investigations it prompted into the work of the FDA, one of them headed by Senator Kefauver who recommended Dr. Kelsey for the Distinguished Federal Civilian Service Award, an honour backed by Senators Mundt of South Dakota and Hubert H. Humphrey of Minnesota. As a result, Dr. Kelsey was honoured by President Kennedy at a White House ceremony on August 7, 1962.

Dr. Kelsey returned to the FDA to direct a new branch established to maintain close surveillance of the testing of all drugs. She still works there in an advisory capacity. A naturalized citizen of the United States since 1955, she received an honorary degree from the University of New Brunswick in 1962 and another from McGill in 1984.

As for the drug thalidomide, it didn’t disappear. It has been used for years to treat leprosy in Mexico, the Philippines, South America, and Asia. In 1996, a Los Angeles Times story reported that researchers have found it effective in treating certain AIDS-related conditions such as painful mouth ulcers and severe body wasting. It is also believed it may have an impact on Crohn’s disease, multiple sclerosis, arthritis, and Alzheimer’s disease.

Mel James