Frances Oldham Kelsey
When Dr. Kelsey Said No
1914 – 2015

In the mid 1900s, when a German pharmaceutical company produced and marketed a drug in Europe and other countries, the medication was touted as a remedy for anxiety and sleep loss. However, by 1961 there were concerned reports that when prescribed for pregnant women, the drug might cause congenital abnormalities or even stillbirth.

And in the United States? Though the product had not been officially approved by the Federal Drug Administration (FDA) there had been some access to the product—yet generally American infants were spared. Why? Because one hesitant and suspicious FDA staff member delayed agency approval despite pressure from a drug company, Dr. Frances Oldham Kelsey continued to defer the approval as she sought more research detail from the drug company. According to one source, her “…steadfast refusal to approve thalidomide in the U.S. was a defining moment in medical history. Her skepticism and insistence on thorough drug testing saved countless lives …” Then in 1962 she was honored with a presidential award for her efforts and later, legislation and governmental decrees installed new procedures, to deal with future such issues.

In short—it could be said that American infants were largely unaffected by the international tragedy of thalidomide—because Dr. Kelsey said no.

Canadian-American pharmacologist/physician Frances Kathleen Oldham was born in British Columbia, Canada in July, 1914. After graduating from university with basic and advanced degrees, she applied to continue graduate work at the University of Chicago pharmacology department. She was accepted and began in 1936.

The next year Oldham became involved in an FDA drug test that helped her realize the importance and necessity of the proper regulations concerning safe procedures. Then in 1938 there was passed the Federal Food, Drug and Cosmetic Act which would improve protection; and that year she completed her doctorate at Chicago.

Frances Oldham then joined the University of Chicago faculty and in one test she learned even more—how some drugs can pass through the pregnant woman’s placenta and thus affect the fetus—it was a memorable realization.

In 1943 she and fellow faculty member, Fremont Kelsey were married, and then she received her M.D. degree in Chicago in 1950. After that, she and her family moved South Dakota, where Dr. Kelsey taught at the University in Vermillion. Then to make it easier to continue practice medicine in the U.S., she became a dual citizen of both Canada and the U.S.

As Dr. Kelsey took a position with the FDA in Washington in 1960, she was (according to one source) “one of only seven fulltime and four young part time physicians reviewing drugs.” As she settled into the job, one of her first tasks was to review the application of a major drug company for approval of American use of the drug that became known as thalidomide.

Marketed under various trade names, thalidomide had been approved and was in use in Europe and other nations, but before FDA approval, a very careful Dr. Kelsey requested the appropriate clinical trial information. At that time the FDA could only withhold approval for just 60 days at a time, so Dr. Kelsey continued to ask for continuous 60 day periods, for over a year. Her reasoning for the delays was her skepticism about research methods and veracity of study authors.

Then in December, 1960 she saw a letter in a British medical periodical that connected certain questionable neurological effects to thalidomide, and so she asked the drug company for further details on the subject. Her suspicions were aroused because she remembered her previous work with the mechanism of congenital defects, and she sought more complete studies, to assure that an unborn baby would be unharmed if the drug was used by the mother. However, the continued delaying requests irritated the drug company and they began pressuring her agency for approval, even contacting Dr. Kelsey’s superiors. However, they supported her.

By November, 1961 her refusal to approve the drug’s use in the U.S. was vindicated, as the number of deformed infants born to women who had taken thalidomide rose in Europe. Researchers had realized that the drug could indeed cross the placental barrier and damage to the unborn was often very much a possibility. It was then discovered that some of the drug had been distributed in the U.S. and there had indeed been some recorded defects and more were suspected. Then in March, 1962 the company withdrew their FDA request.

In the end Dr. Kelsey was recognized for her fortitude by the national press that described how she had “…prevented the births of hundreds or indeed thousands of armless and legless children.” She carefully shared the kudos with her assistants as well as her FDA superiors, and by July that a later Washington Post article provided more information that led to procedural changes. From that point on, companies had to demonstrate the efficacy of new drugs, and report adverse reactions. As one source put it, “Companies were required to demonstrate the efficacy of new drugs, report adverse studies.

Then in August of 1962 for her blocking approval of thalidomide Dr. Kelsey received the President’s Award for Distinguished Federal Civilian Service by President John F. Kennedy. She then continued her service with the FDA.

One effect from the publicity came when in Congress Senator Estes Kefauver, who had for several years tried to investigate pharmaceutical companies for their pricing practices, introduced legislation supporting protective legislation.

Dr. Kelsey retired from the FDA in 2005 at age 90 after serving for 45 years. Then five years later it was announced the winner of a first Drug Safety Excellence Award was to be named for her. After turning 100 in 2014 Dr. Kelsey returned to live in Canada, and then a year later was awarded the Order of Canada amidst praise from members of the Thalidomide Victims Association of Canada. She died in London, Ontario in 2015 at the age of 101.

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Anne Adams is a retired church staffer. She lives in East Texas and has an historical column for a local newspaper. She has published in Christian and secular publications for more than 40 years.

References:
Wikipedia
Changing the face of Medicine
Chicago Medicine