Frances Oldham Kelsey may have been the most brilliant medical officer that Canada never had. She gave her truly lasting gift to the United States, performing one of the most celebrated acts of public service of the 20th century.
Dr. Kelsey knew her mind, even as a novice at the U.S. Food and Drug Administration at the dawn of 1960s. She was a rarity – a woman, and a Canadian to boot – when a seemingly routine application crossed her desk. It was for a new drug called thalidomide, a "miracle" medication billed as safe for pregnant women suffering from insomnia and morning sickness.
The drug executives thought she would be a pushover.
They didn't know Dr. Kelsey.
Exacting, astute, and unshakable in her faith in science, Dr. Kelsey, who died on Aug. 7 in London, Ont., at the age of 101, was not one to be bullied. No matter how much the William S. Merrell Co. lobbied to get the drug approved, she would not be rushed.
She insisted on having more proof of its safety, effectively stalling for time months before the drug's horrors were fully exposed.
Ultimately, thalidomide never got the go-ahead, and the United States – unlike Canada and dozens of other countries – was spared one of the worst drug disasters of all time.
"She was just very clear, very quiet and very calm, and said no," said her daughter, Christine Kelsey. "She was quietly spoken but firmly spoken, and she was always very strong in her convictions. And she was very confident in her scientific knowledge."
In one of her final interviews, Dr. Kelsey told The Globe and Mail she had been expected to rubber-stamp Merrell's application because thalidomide had been popular in Europe; countless consumers were already using it in Britain and in Germany, where it was developed.
Even at age 100, reliant on a wheelchair and with her hearing nearly gone, Dr. Kelsey demonstrated in that interview the same lively mind and firmness of will that guided her during the historic episode in Washington, D.C., a half-century earlier.
"I held my ground. I just wouldn't approve it," she said in her home in suburban Washington, where she lived before moving back to Canada late last year.
"Representatives for the company thought I was crazy because it was such a popular drug in Europe, and they were losing money by my pigheadedness. The company wasn't happy with me."
Frances Oldham was born on July 24, 1914, in Cobble Hill, B.C., a small community on Vancouver Island, one of four children of a Scottish mother and a father who had been an officer in the British Army.
From her mother's side came role models of accomplished women; one aunt was a doctor and another, a lawyer. Young Frankie's childhood was spent exploring the fields, streams and forests around the idyllic family home. She was sent for some of her earliest schooling to an all-boys' private school because her parents expected her to get as good an education as her older brother; she was the only girl at the school for several terms.
After studies in British Columbia, her interest in biology led her to McGill University in Montreal, where she earned undergraduate and graduate degrees in science. She also showed distinction beyond the classroom: Her McGill basketball team won championships in the early 1930s.
Her first choice was to remain at home and get a job in Canada, but it was the depths of the Great Depression and she couldn't find work. So she took her McGill professor's advice and applied to be a research assistant in the University of Chicago's new pharmacology department.
After mailing a letter to the department, she received a response offering a position; the professor mistook Frances for a man and addressed her as "Mr. Oldham." She didn't correct him and took the position, musing years later that had her name been "Elizabeth or Mary Jane," she may never have got her first break.
At the University of Chicago, she met and married a fellow pharmacologist, Fremont Ellis Kelsey, and gave birth to their two daughters while working toward her medical degree.
Dinnertime conversations revolved around science and work-related topics. "We learned some of our first words, like isotopes, from them," said her other daughter, Susan Duffield. Her mother taught the two girls about the importance of science: "She would say, 'Don't just guess something, prove something.'"
Dr. Kelsey later got a job as an editorial assistant reviewing physician-submitted articles for the Journal of the American Medical Association, a stint that would prove useful when it came time to evaluate thalidomide's claims. "I soon learned … that good scientists are almost invariably good writers and that poor writing is often a sign of poor science," she later recalled.
After several years in South Dakota, where Dr. Kelsey did research and practised as a physician, she and her husband decided to move their family to Washington, where she was offered a job with the then-expanding FDA and her husband found work at the National Institutes of Health.
In many ways, the combination of Dr. Kelsey's character and her particular set of career skills came together fortuitously when it was time to assess the thalidomide application in the fall of 1960. The pressure was great. Executives from Merrell wrote, phoned and showed up to try to persuade her to approve their application, but she would not relent.
Derided by her detractors as an obstructionist nitpicker, she was ultimately vindicated. In early 1961, she spotted a letter in the British Medical Journal by a Scottish physician who noted incidents of nerve damage among his patients taking thalidomide.
Dr. Kelsey asked Merrell why the company had never mentioned the troubling side effect; she also began to press company representatives about the effects of thalidomide on the fetus, for which the drug makers had not done any testing.
"It was just too overblown," Dr. Kelsey told The Globe about the company's pitch. "And they didn't have any evidence to submit."
By November, 1961, the full scope of the thalidomide tragedy began to unfold. News from Europe linked the drug to birth defects, including stunted or missing limbs, heart malformations, deafness and blindness.
Thalidomide was yanked from the shelves in Europe by the end of the year. To Canada's shame, it remained available in this country for three more months, until March, 1962.
Soon, Dr. Kelsey, an anonymous civil servant, shot to renown. A front-page article in The Washington Post focused on her behind-the-scenes work and she became a hero in an age where women were still breaking out of their traditional roles. "A Woman Doctor who Would Not be Hurried," read the headline of a Life magazine article about her. "Lady Cop," wrote Newsweek. A 1962 opinion poll rated her one of the most admired women in the world. Her image and an account of her work was used on a recruitment poster for the U.S. civil service.
Dr. Kelsey's coup helped push through tighter U.S. rules on how drugs would be reviewed and approved, ushering in a modern and science-based drug-approval system.
Accolades followed. In August, 1962, she turned up on the White House lawn in a proper hat and white gloves to receive the Award for Distinguished Federal Civilian Service from a smiling John F. Kennedy. The president praised her "exceptional judgment" in preventing tragedy in the United States.
Recognition in her homeland was slow in coming, however, perhaps because Dr. Kelsey's courage reflected poorly on Canada's conduct.
It was only this year, after the federal government belatedly offered its regrets and agreed to grant pensions to Canada's nearly 100 thalidomide survivors, that Dr. Kelsey was named a Member of the Order of Canada. The insignia for the honour was presented to her on Aug. 6 at Christine Kelsey's home in London, Ont., less than 24 hours before Dr. Kelsey's death.
In person, Dr. Kelsey showed self-assurance, a penchant for dry wit, and a mannered insistence on sending a properly written thank-you note. She remained a devoted civil servant well into her senior years, showing up for work at the FDA until the age of 88.
She devoured biographies and played bridge or a round of golf often as she could. During The Globe's visit to her Washington home last fall, the centenarian gamely posed for photos and perused a crossword puzzle as she sat overlooking her beloved vegetable garden.
Coincidentally, Dr. Kelsey returned to Canada just after The Globe and Mail published an award-winning exposé about the devastating legacy left by thalidomide on the country's nearly 100 victims. The Globe's coverage resulted in a unanimous parliamentary motion to support the victims, and this year Ottawa announced they would receive up to $100,000 each in annual pensions for the rest of their lives.
To the Canadian survivors of the drug, who suffered the tragic consequences of their country's lapses, Dr. Kelsey represented a potent symbol of conscientiousness and public duty. She also stood out as a heroic figure in a story dominated globally by corporate greed and government negligence.
Dr. Kelsey, who became a naturalized American in 1956, remained deeply attached to her homeland. She never missed a chance to visit Vancouver Island's Cowichan Bay with her daughters to go salmon fishing. A framed watercolour of her childhood home remained with her throughout her adult life, and it hung on the wall, at the foot of her bed, where she spent her final days.
Dr. Kelsey, whose husband died in 1966, leaves her two daughters, two grandsons, and a sister, Monica Oldham, of Victoria. Her family intends to bury her ashes on Vancouver Island, in Cobble Hill.
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