Dr. Frances Oldham Kelsey became a 20th-century American heroine for her role in the thalidomide case, celebrated for her vigilance, which spared the United States from widespread birth deformities, and for giving rise to modern laws regulating pharmaceuticals.
The sedative was Kevadon, and the application to market it in the United States reached the new medical officer at the Food and Drug Administration (FDA) in September 1960. The drug had been sold to pregnant women in Europe for morning sickness, and the application seemed routine, ready for the rubber stamp.
But some data on the drug’s safety troubled Dr. Frances Oldham Kelsey, a former family doctor and teacher in South Dakota who had just taken the FDA job in Washington, reviewing requests to license new drugs. She asked the manufacturer, the William S. Merrell Co. of Cincinnati, for more information.
Thus began a fateful test of wills. Merrell responded. Dr. Kelsey wanted more. Merrell complained to Dr. Kelsey’s bosses, calling her a petty bureaucrat. She persisted. On it went.
But by late 1961, the terrible evidence was pouring in. The drug — better known by its generic name, thalidomide — was causing thousands of babies in Europe, Britain, Canada and the Middle East to be born with flipperlike arms and legs and other defects.
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Dr. Kelsey, who died Friday at age 101, became a 20th-century American heroine for her role in the thalidomide case, celebrated for her vigilance, which spared the United States from widespread birth deformities, and for giving rise to modern laws regulating pharmaceuticals.
She was hailed by citizens groups and awarded honorary degrees. Congress bestowed on her a medal for service to humanity and passed legislation requiring drugmakers to prove that new products were safe and effective before marketing them. President Kennedy signed the landmark law that she had inspired, and presented her with the nation’s highest federal civilian-service award.
“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,” Kennedy said at a White House ceremony.
Dr. Kelsey was appointed to the Order of Canada last month and presented with the honor in a private ceremony the day before her death at her daughter Christine Kelsey’s home in London, Ontario, where Dr. Kelsey had been living, according to John Swann, a friend and a historian at the FDA.
In 1962, the FDA set up a branch to test and regulate new drugs, and Dr. Kelsey was put in charge. Later, she became director of the agency’s Office of Scientific Investigations, and in a distinguished 45-year career with the FDA helped rewrite the nation’s medical-testing regulations, strengthening protections for people and against medical conflicts of interest. The rules have been adopted worldwide.
She was born Frances Oldham in Cobble Hill, on Vancouver Island, B.C., on July 24, 1914, one of three children of Frank and Katherine Stuart Oldham.
She attended schools in Victoria and McGill University in Montreal, earning a bachelor’s degree in 1934 and a master’s in science in 1935. She went on to earn a doctorate in pharmacology and her medical degree at the University of Chicago.
She and Dr. Fremont Ellis Kelsey, a professor in the university’s pharmacology department, married in 1943. He became a special assistant to the surgeon general in 1962 and died in 1966. The couple had two daughters.
Besides her daughter Christine, Dr. Kelsey is survived by another daughter Susan Duffield, two grandsons and a sister.
She taught and had a private medical practice before her husband was appointed to a post at the National Institutes of Health in Washington in 1960. She accepted the FDA job evaluating applications for licenses to market new drugs. Merrell’s was one of the first to cross her desk.
The company made glowing claims for Kevadon’s safety and effectiveness. It had been developed in West Germany, and since 1957 had been widely sold in Europe and elsewhere as an excellent sedative, Merrell said, giving prompt, deep, natural sleep without hangovers. Moreover, doctors had recently been prescribing it to women to suppress nausea in pregnancy.
There were laws governing new drugs but they were not rigorously enforced, and FDA approval was often routine. But Dr. Kelsey, working with a chemist and a pharmacologist, found the evidence for Merrell’s claims about Kevadon to be insufficient. She withheld approval and asked Merrell for more data on toxicity, strength and purity.
Merrell stood to make millions and was anxious to get moving. It had tons of Kevadon in warehouses, and 1,000 U.S. doctors had already been given samples for “investigational” research.
Dr. Kelsey She refused to be hurried, insisting that there was insufficient proof. In February 1961, she read a letter in The British Medical Journal from a doctor who suggested thalidomide might be causing a numbing condition in arms and legs. She notified Merrell, and the company began its own inquiry. In May, she told Merrell the drug might affect the limbs of fetuses. The company called the evidence inconclusive.
“I had the feeling,” she wrote after a meeting with company executives, “that they were at no time being wholly frank with me, and that this attitude has obtained in all our conferences, etc., regarding this drug.”
Six months later, European reports indicated the drug was linked to an epidemic of phocomelia, a rare malformation of limbs in newborns. Merrell withdrew its application as reports of the births of “thalidomide babies” came in from many countries. Kevadon samples given to U.S. doctors were traced, but not all were retrieved. Seventeen births of deformed babies in the United States were reported.
Eventually researchers learned that thalidomide crossed the placental barrier and retarded development of the fetus, whose drug-metabolizing enzymes are undeveloped. No one knows how many babies were affected by thalidomide, but estimates range into the tens of thousands in Europe alone.
Many were born without arms or legs, some with no limbs or with withered appendages protruding directly from the trunk. Some had no external ears or deformities of the eyes, the esophagus or intestinal tracts.
After an article in The Washington Post led to global coverage, Dr. Kelsey was hailed as a hero. She insisted that her pharmacologist, Oyam Jiro, and chemist, Lee Geismar, and her superiors share the credit. But attention focused on her, partly because the Kennedy administration and its allies in Congress wanted to use the case to pass stronger drug regulations.
The 1962 law required tighter proof of the safety and effectiveness of new drugs, full disclosure of side effects and generic names, and swift removal of unsafe drugs from the market.
When she became widely known, Dr. Kelsey seemed modest to the point of shyness. But she testified in Congress, spoke to women’s groups and at college forums and gradually became accustomed to the spotlight.
In 2000, she was inducted into the National Women’s Hall of Fame, joining the ranks of Helen Keller, Eleanor Roosevelt, Margaret Mead and others. She retired in 2005, and in 2010 was honored by Dr. Margaret Hamburg, then the FDA administrator, as the first recipient of an award that continues to be given annually in her name.