KELSEY, Frances Kathleen Oldham

(b. 24 July 1914 in Cobble Hill, Vancouver Island, British Columbia, Canada), pharmacologist, physician, and U.S. government employee who gained national fame in 1962 for single-handedly preventing the sedative drug thalidomide from being marketed (and thus prescribed for patients) in the United States.

Kelsey was born Frances Oldham, the daughter of Frank Trevor Oldham, a retired British army officer, and Katherine Stuart. She had two brothers. After completing her early education in Victoria on Vancouver Island, she entered McGill University in Montreal, where she received a B.S. in 1934 and an M.S. in 1935. In 1936 Kelsey moved to the United States to attend the University of Chicago. She earned a Ph.D. in pharmacology in 1938 and joined the faculty of the department of pharmacology at the university that same year.

Kelsey had influential colleagues at Chicago. E. M. K. Geiling, a pioneer in the field of pharmacology, instilled in Kelsey the importance of studying the effects of drugs on the body and the need for scrupulously high standards of research. Kelsey, Geiling, and another pharmacologist, Freemont Ellis Kelsey, performed experiments that demonstrated the antimalarial drug quinine was lethal to rabbit fetuses although harmless to adult rabbits. Their studies were among the first to show that the effects of drugs on the unborn could be very different from the effects on adults. Kelsey maintained her interest in this phenomenon all her life, as well as maintaining her interest in Freemont Kelsey. The two were married on 6 December 1943. After marrying, Kelsey left her job and entered medical school. She received an M.D. from the University of Chicago in 1950 and had two daughters while in school. She worked as an editorial associate for the American Medical Association in Chicago from 1950 to 1952, after which the Kelseys moved to South Dakota. Both taught pharmacology at the University of South Dakota Medical School, Frances Kelsey from 1954 to 1957. She completed an internship and was in private practice from 1957 to 1960. Kelsey became a naturalized U.S. citizen in 1956.

In 1960 Freemont Kelsey's work brought the family to Washington, D.C. That August, Kelsey accepted a position as a medical officer with the Food and Drug Administration (FDA). Her responsibility was to evaluate license applications from pharmaceutical firms seeking to market new drugs in the United States. It was an unglamorous job in an agency fraught with problems. The Antitrust and Monopoly Subcommittee of the Senate Judiciary Committee, chaired by Senator Estes Kefauver of Tennessee, was conducting a major investigation of the drug industry at the time, and the FDA was suspected of having a less than ethical relationship with the industry.

Kelsey's first major assignment was to review an application submitted in September 1960 by the William S. Merrell Company of Cincinnati. The company was requesting permission to market the sedative drug thalidomide under the brand name Kevadon. Thalidomide was already widely used in Europe, mainly as a sleeping pill, but it was also prescribed for other conditions, including morning sickness during pregnancy. The firm Chemie Grunenthal had developed the drug in West Germany, and it had been on the market there since 1957.

Kelsey was not satisfied with the research presented in Merrell's application, indicating it did not provide enough information about how thalidomide worked. She was particularly concerned about the possible toxicity of thalidomide in certain populations, including unborn babies. Kelsey withheld approval of the application, asking Merrell to provide more complete data. The company complied, but Kelsey was still not satisfied. When she rejected the application for a second time in January 1961, Dr. Joseph Murray, a representative from Merrell, began applying pressure by repeatedly contacting both Kelsey and her superiors with complaints about the delay. Murray referred to Kelsey as "nitpicking" and "unreasonable," but her resolve only became stronger after reading a report in the December 1960 British Medical Journal that suggested thalidomide might be causing numbness in the arms and legs of some patients. She rejected Merrell's application for a third time in March 1961, asking once more for better evidence of the drug's safety.

The battle between Kelsey and Merrell continued over the next several months, as disturbing reports began to emanate from Europe, where large numbers of women were giving birth to severely deformed babies. Many of the babies exhibited phocomelia, a previously rare condition that results in abnormally short and malformed limbs. By November 1961 German doctors were associating the birth defects with women who had taken thalidomide during their first three months of pregnancy. The drug was quickly pulled from the German market, and countries worldwide followed suit. In late November 1961 Merrell withdrew its application to market thalidomide in the United States.

Over ten thousand babies in forty-six countries had been exposed to the devastating effects of thalidomide. As stories and images of horrible deformities reached the United States, people slowly began to realize that Kelsey had virtually single-handedly prevented a national tragedy. On 15 July 1962 the Washington Post ran a front-page story with the headline "Heroine of FDA Keeps Bad Drug Off of Market." It began, "This is a story of how the skepticism and stubbornness of a government physician prevented what could have been an appalling American tragedy, the birth of hundreds, or indeed thousands, of armless and legless children."

On 7 August 1962 President John F. Kennedy presented Kelsey with the Distinguished Federal Civilian Service Award, which stated, "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." In October 1962, with Kelsey present at the ceremony, Kennedy signed the landmark Kefauver-Harris Amendments to the federal Food, Drug, and Cosmetic Act of 1938. The amendments required a drug to be proven both safe and effective before it is approved for the U.S. market. They also gave the FDA greater control over drug experimentation on human subjects.

In December 1962 Kelsey became head of the new Investigational Drugs Branch of the FDA, whose function it was to regulate the testing of new drugs. She continued to work in various capacities at the FDA for the rest of her career, which lasted until she was well into her eighties. On 7 October 2000 Kelsey was inducted into the National Women's Hall of Fame in Seneca Falls, New York.

Kelsey's collected papers, primarily from the 1960s, are located at the Library of Congress in Washington, D.C. Chapter-length biographies include "The Doctor Who Said No," in Margaret Truman, Women of Courage (1976); and "Francis Oldham Kelsey and Thalidomide," in William Hoffman and Jerry A. Shields, Doctors on the New Frontier: Breaking Through the Barriers of Modern Medicine (1981). An article entitled "Drug Market Guardian: Frances Oldham Kelsey" appeared in the New York Times (2 Aug. 1962). Other biographical sources include Notable Women in the Life Sciences: A Biographical Dictionary (1996).

Victoria Tamborrino