Frances Oldham Kelsey Biography (1914-)

pharmacologist, physician

Frances Oldham Kelsey became nationally famous in 1962 when she prevented thesedative drug thalidomide from entering the United States. Thalidomide was found to have caused birth defects in 10,000 European children in the late 1950s and early 1960s. For preventing an American thalidomide tragedy, Kelsey was awarded the government's highest civilian award, the President's Distinguished Federal Civilian Service Award. Kelsey's vigilance led to the strengthening of investigational drug regulations, greater attention to the safety of drugs in pregnancy, and increased interest in research on teratology, the biological study of congenital deformities and abnormal development.

Kelsey was born in Cobble Hill, British Columbia, on July 24, 1914. In 1934,she received a bachelor's degree in science from McGill University in Montreal and attained a master's degree in science there in 1935. Kelsey received her professional degrees, a doctorate in pharmacology in 1938 and an M.D. in 1950, from the University of Chicago. She completed an internship at Sacred Heart Hospital in Yankton, South Dakota, in 1954 and was associate professor ofpharmacology at the University of South Dakota from 1954 to 1957. She remained in South Dakota until 1960, and was in private practice there between 1957and 1960. In 1955, Kelsey became a naturalized U.S. citizen. She had marriedF. Ellis Kelsey in 1943, and they had two children.

Early in her career, Kelsey investigated the cause of 107 deaths, most of them in children, from a new sulfa drug. In the 1940s, she coauthored several papers with her husband on the metabolism of antimalarial drugs. In 1943, they published a study in the Journal of Pharmacy and Experimental Therapy about the effects of antimalarial drugs on the embryo. They found that the drug could be broken down by the liver of adult rabbits, but fetal livers could not break it down, and the drug could have deleterious effects. This research laid the groundwork for Kelsey's continuing interest in the safetyof drugs during pregnancy.

Kelsey's civil service career began in August, 1960, when she became a medical officer for the Food and Drug Administration (FDA). After one monthon the job, Kelsey was asked to review what was expected to be a simple and routine marketing application for thalidomide. Thalidomide, a sleep inducer, had been developed in West Germany in the 1950s, and was widely marketed in Europe; belief in its safety was so widespread that the drug was available without prescription.

Kelsey soon became suspicious of the safety of thalidomide. In February, 1961, she read a letter from a doctor in the British Medical Journal suggesting an association between thalidomide and peripheral neuritis, a tingling sensation in the arms and legs of adult users. Kelsey promptly asked Richardson-Merrill, distributor of thalidomide, for additional animal study data and reports of all clinical trials of thalidomide to supplement the company's application for American approval. She later notified the company that she suspected thalidomide might have some effect on unborn children, although she did not yet suspect it as a cause of deformity. Throughout her review, Kelsey remained concerned that the company had failed to provide adequate data to demonstrate the safety of thalidomide.

In November, 1961, a German scientist alleged a strong association between use of the drug by pregnant women and an increase in deformed babies born in Germany. Finally, in December, 1961, the company acknowledged the German reports and requested that women of childbearing age discontinue its use. More than10,000 cases of phocomelia, a condition causing underdevelopment or absenceof arms and legs, in European children were eventually attributed to use of thalidomide. Seventeen cases of thalidomide embryopathy resulting from a then-legal experimental distribution of the drug were later documented in the United States.

On July 15, 1962, the Washington Post ran an article about Kelsey that began, "This is the story of how the skepticism and stubbornness of a government physician prevented what could have been an appalling American tragedy...." A wave of publicity and acclaim swept the world. Only a month later, Congress voted to award a gold medal to Kelsey "in recognition of the distinguished service to mankind ... by withholding, despite the great pressures brought to bear upon her, approval of the horror-drug thalidomide which has causedthousands of babies to be deformed." In October, 1962, with Kelsey present at the ceremony, President Kennedy signed a landmark drug law, the Kefauver-Harris Amendments . The law required drug manufacturers to register with the Food and Drug Administration proof that new drugs were both effective and safe,and provided for more rapid recall of new drugs deemed hazardous. In 1963, Kelsey became chief of the Investigational Drug Branch of the FDA, and in 1968was appointed to her current position as director of the Office of Scientific Investigations.

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