In the late 1950s and early 1960s about 2,000 children died and 10,000 were born malformed as a result of their mothers taking the drug thalidomide during pregnancy.
Only 17 of these ‘thalidomide babies’ were born in the United States, largely because Frances Oldham Kelsey blocked American sales of thalidomide, stating that its manufacturers had not fully assessed the drug’s risks.
Beginnings
Frances Kathleen Oldham was born on July 24, 1914 in the farming village of Cobble Hill on Vancouver Island, British Columbia, Canada. Her parents had moved to Canada from the United Kingdom: her mother, Katherine Stuart, with her family from Scotland, and her father, Frank Oldham, from England.
Frances was born just a couple of weeks before World War 1 began in Europe. Her father was a retired British army officer, and he returned to Britain to rejoin the army for the duration of the war. Frances was one of four children – two sons and two daughters. Her parents called her Frankie.
Living on a wooded homestead of about 30 acres, Frances learned to enjoy the natural world from an early age.
When she saw her mother beginning to teach her older brother to read and write, Frances, who was two years younger, copied her brother and soon she was reading and writing too.
Education
Frances began her schooling at Leinster Preparatory School, an all-boys preparatory school close to home. For a few terms, she was the only girl at the school.
Next she attended Saint Margaret’s School in British Columbia’s capital city, Victoria. Saint Margaret’s was about 30 miles (50 km) from home, and Frances boarded there. This was followed by university undergraduate level courses at Victoria College, where she spent two years studying biology and zoology.
Her next move took her over 3,000 miles (5,000 km) from home, to the city of Montreal, to study science at McGill University. She graduated with a Bachelor of Science degree in 1934, aged 20. This was during the Depression, and there were very few jobs around for young university graduates. Oldham decided to study for a Master of Science degree in Biochemistry. Unfortunately, the Biochemistry course at McGill was already full, so she studied Pharmacology instead, graduating in 1935, aged 21.
Next, in 1936, the University of Chicago accepted her application to study for a Ph.D. in Pharmacology. However, her acceptance letter was addressed to Mr. Oldham, which worried her. Chicago believed they had accepted a man. She wrote back, letting them know she would be coming to Chicago and made it clear she was a woman. She learned later that Professor Gelling, whose research group she joined, was horrified when he realized he had recruited a woman. Despite this, he welcomed her to his group. In 1938, aged 24, Oldham was awarded her doctorate.
Frances Oldham working on her Ph.D. with Professor Eugene Geiling.
Frances Kelsey’s Career in Science
Mass Poisoning in 1937
While working for her doctorate, Oldham carried out research on a drug called elixir sulfanilamide, which caused 107 deaths in 1937. Professor Geiling’s team discovered that the fatalities were caused by diethylene glycol poisoning. Diethylene glycol had been used in the medicine to dissolve the active part of elixir sulfanilamide.
University of Chicago
After completing her Ph.D. Oldham was offered and accepted a faculty position at the University of Chicago. By 1942, she was studying drugs that might cure malaria. This work led her to become increasingly interested in drugs that pass from mother to fetus through the placenta.
In 1943, Oldham married her Chicago colleague Dr. Fremont Ellis Kelsey and so became Frances Kelsey. It was as Frances Kelsey that she became famous a few years later.
In 1950, she qualified as a doctor of medicine.
Thalidomide
In August 1960, the Food and Drug Administration (FDA) in Washington, D.C. appointed Kelsey as a Medical Officer. Her job was to review applications for drug approvals in the USA.
One of the very first applications that crossed her desk was for thalidomide, a drug that reduced nausea and also acted as a painkiller and tranquilizer. The application, from the company Richardson-Merrell, identified pregnant women suffering from morning sickness as particularly suitable candidates to receive the drug.
The drug had been invented in Germany in 1953 and had been approved for use in Germany, Australia, Canada, Japan, Sweden, the UK, and 40 other countries.
Richardson-Merrell wanted the FDA to approve the drug quickly for use in the USA. Even without approval, American law at the time allowed the company to send experimental samples to doctors. Richardson-Merrell sent 2.5 million tablets to over 1,000 American doctors who administered it to almost 20,000 patients, hundreds of whom were pregnant.
Kelsey was unimpressed by Richardson-Merrell’s application. She refused to approve it, telling the company their risk assessment of the drug was inadequate. She told them to provide her with more data from controlled studies before she would be persuaded that the drug was safe. Kelsey was worried when she realized no trials had been carried out on pregnant animals to discover if the drug could cross the placenta.
Although the company repeatedly pressurized her to back down and also lobbied her bosses at the FDA, she held firm to her scientific and ethical principles.
Blocking Thalidomide
Three scientists were needed to approve a new drug – a chemist, a pharmacologist, and a medical officer.
In the case of thalidomide, these scientists were Lee Geismar (chemist), Jiro Oyama (pharmacologist), and Frances Kelsey (medical officer). Kelsey’s role was to review the safety and efficacy of the drug. All three scientists found problems with the application to approve thalidomide.
FDA Drug reviews had to be completed within 60 days, otherwise a drug’s approval became automatic. At 60 day intervals, Kelsey blocked the approval of thalidomide, requesting more data. Finally, a storm of bad publicity about the drug blew in from Europe and Australia, and the drug was withdrawn.
In November 1961, thalidomide was withdrawn in Germany for use by pregnant women. The drug was crossing the placenta from mother to fetus, causing shrinkage and deformities in the limbs of fetuses. In many cases, babies were also born with malformed eyes and ears.
Although 10,000 children were born in the world with severe defects, only 17 were born in America. A grateful American government and public thanked Frances Kelsey for her work.
“…some seventeen deformed children born in this country; in about half of these the drug had been obtained overseas.”
In 1962, President John F. Kennedy presented Kelsey with the President’s Award for Distinguished Federal Civilian Service. Also in that year, President Kennedy signed legislation tightening the experimental use of drugs and strengthening the authority of the FDA.
Frances Kelsey, aged 48, receives the President’s Award.
Senior Scientist
In 1963, Kelsey was appointed head of the FDA’s investigational drug branch. In 1967, she became director of the office of scientific investigations, a position she held until she was 80 years old, standing down in 1995.
She continued working at the FDA as an advisor until finally retiring aged 90 in 2005.
Some Personal Details and the End
In 1943, Frances Oldham married her University of Chicago colleague Dr. Fremont Ellis Kelsey and so became Frances Kelsey. The couple had two daughters, Christine and Susan.
Kelsey became an American citizen in 1955. Her husband died in 1966.
At the age of 90, Kelsey retired to pursue her hobbies of gardening and solving crosswords.
Frances Kelsey died at the age of 101 on August 7, 2015 in her daughter’s home in London, Ontario, Canada.
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Further Reading
Imperial Vancouver Island: Who Was Who, 1850-1950
J. F. Bosher
Xlibris Corporation, 2010
https://www.fda.gov/downloads/AboutFDA/WhatWeDo/History/OralHistories/SelectedOralHistoryTranscripts/UCM406132.pdf