She was the girl from Cobble Hill who grew up to be one of the outstanding scientists of the 20th century.
Although she turned 100 last summer, Dr. Frances Oldham Kelsey — the physician and drug investigator who kept thalidomide from the U.S. market — still thinks of herself as a Vancouver Island girl. “Oh yes,” she said with emphasis in a recent interview from her daughter’s home in London, Ont. “I sure love Vancouver Island.”
If anything, she sounds more animated about growing up in her family’s rural Shawnigan Lake Road home than when asked, yet again, about how she saved thousands of American children from cruel deformities as a result of the early 1960s drug, prescribed to pregnant women for relief of insomnia and morning sickness.
A working scientist who did not officially call it quits until she was 91, Kelsey isn’t one to solicit praise — science is science. But talking up her love of Cobble Hill, no problem. She has a message for people living there today: “I envy them,” she said.
In the late summer of 1960, after only one month on the job as a medical officer at the U.S. Food and Drug Administration in Washington, D.C., Kelsey was asked to review a new drug application for thalidomide. It had already been approved in Canada and 20 other countries, and pharmaceutical firm Richardson-Merrell wanted access to the huge U.S. market before Christmas. But Kelsey felt claims made for thalidomide sounded too glowing and required more substantiation. She refused to approve it, despite pressure from the company. “They thought I was nuts,” Kelsey said of the company.
An MD with a PhD in pharmacology, she had so much courage in her scientific convictions that University of Vancouver Island historian Cheryl Warsh ranks Kelsey among the top five scientists in Canadian history, along with diabetes-treatment pioneers such as Frederick Banting and Charles Best, in terms of global importance and recognition. “She was a pioneer woman scientist in Canada and there were so few.”
Carleton University medical historian Susanne Klausen, who is writing about thalidomide in South Africa, agreed that Kelsey is an icon.
“I think it was extraordinary to be so brave in the face of the kind of pressure she was facing, to stick to her guns and not allow that drug to be licensed, because by doing so, she prevented no doubt hundreds, if not thousands, of children from becoming affected by thalidomide.” It was even more to her credit, considering that Kelsey was new to Washington and in a male-dominated landscape, added Klausen, who grew up in Sidney.
Kelsey is back in the news, not just because of her centenary, but because 95 surviving Canadian thalidomide victims have entered their 50s with ever more serious health problems due to truncated limbs, widespread nerve damage, arthritis, deafness and blindness. The Thalidomide Victims Association of Canada is calling on Ottawa for $250,000 in lump-sum payments for each of them, plus annual support starting at $75,000, said executive director Mercedés Benegbi, who recently met with Health Minister Rona Ambrose. “We have a lot of hope but also a lot of work to do.”
In 1991, Ottawa awarded small lump-sum grants to thalidomide survivors born in Canada, the association says, but “[T]hese payments were quickly used by individuals to cover some of the extraordinary costs of their disabilities, and for most victims, these monies are long gone.” Before that, families were pushed into accepting widely varying financial settlements that did not last long, with a gag order forbidding disclosure of amounts that varied by hundreds of thousands of dollars for the same levels of disability, the association said.
Thalidomide went on sale in Canada on April 1, 1961, and was not pulled until March 1962, three months after most of the world had yanked the drug. There are approximately 5,000 survivors world-wide, the association says. “It’s very sad,” said Kelsey, who was interviewed through her daughter, Christine Kelsey, because of poor hearing.
Kelsey has always steered clear of addressing why Canadian authorities did not take action sooner, but Warsh, who is writing a book on Kelsey and has access to 100 boxes of her papers now in the U.S. Library of Congress, speculates it was “just inertia” that allowed the drug to be sold in Canada and remain available for two years in some drugstores. At that time, drug-safety processes we now take for granted were in their infancy, even for the FDA, which was only beginning to ensure that safety was overseen by people with PhDs in science who stuck around on the job.
“Canada was even more backward,” Warsh said. “Health Canada wasn’t really a big department. It was more about agriculture, making sure that the food was safe.”
Warsh said the lack of action to get thalidomide off the market in Canada was “really unconscionable” because Kelsey had spoken to officials in Canada about her concerns.
“Nobody has really looked that much at what the government was doing,” she said. Yes, there was an announcement that the drug should be taken off the shelves, but no proper chain of communication, never mind enforcement. The fact that thalidomide was aimed at women made it even less likely to be scrutinized, Warsh said.
When birth defects began to show up in the 21 countries where thalidomide was licensed, Kelsey’s role became central to new U.S. drug-safety legislation that, in turn, became the global standard for safety and effectiveness, the FDA website says. But before that, she had caused consternation among higher-ups in the FDA, who were concerned about all the publicity she had attracted.
“They were worried it would raise more pressure against the bill in Congress.
“They also didn’t like it that one person, especially a woman, was getting all of the publicity,” Warsh said. “The FDA emphasized that it was a team effort — as she did, too.”
President John F. Kennedy, who was originally lukewarm on drug-safety legislation, presented Kelsey with the President’s Award for Distinguished Federal Civilian Service on Aug. 7, 1962, in recognition of her role in preventing a thalidomide tragedy in the U.S.
“I was very impressed by him,” Kelsey recalled. After that, it was time to get back and start investigating the next project, she added.
Kennedy was the last president to honour Kelsey. The Presidential Medal of Freedom — the highest U.S. civilian award, which he established in 1963 — has not come her way, although nearly 250 have been bestowed by the last three presidents.
It’s a situation decried two years ago by the Baltimore Post-Examiner in an article headlined “America’s Greatest Living Heroine Frances Oldham Kelsey —98 and forgotten.”In Canada, the Royal Astronomical Society named Asteroid 6260 in her honour. And in 1995, Frances Kelsey Secondary School was officially opened in Mill Bay. It’s fitting, since it’s not far from where Frances Oldham spent her early years, where she honed her quiet self-confidence.
She was one of four children born in a big country house called Balgonie to a well-off Scottish mother, Frances Katherine Stuart, and English father, Col. Frank Trevor Oldham, who went off to the Great War when she was one month old and was away for four years.
“Frankie” was a tomboy from the get-go, running off to catch bugs and frogs in the nearby woods and bringing them home to dissect — as her younger sister Monica told the Victoria Daily Times in 1962.
Warsh said Kelsey lived a “country gentry” kind of life. She attended St. Margaret’s school in Victoria, where she was known for her athleticism as well as her interest in biology, and graduated at 15 determined to be a scientist, then continued her studies at Victoria college. She researched the pituitary glands of whales while working aboard Japanese trawlers on summer breaks from the University of B.C. and McGill University in Montreal. She always assumed she would work in Canada, but the Depression changed that, she told the Times Colonist.
She married her pharmacologist husband, F. Ellis Kelsey, while earning her MD at the University of Chicago — and brought him and their two daughters back to Cobble Hill every summer until her parents died. Her husband died in 1966.
She was practising medicine and on the faculty of the University of South Dakota when she accepted the offer to become a medical officer at the FDA in 1960.
Kelsey spent 40 years in the FDA. Even though she was in charge of its new Division of Scientific Investigations from 1967 to 1995 after her monumental achievement, at one point she worked from an office that was more like a closet, Warsh said. “She never let it get to her. She would never quit in a huff. Because she was raising two girls by herself because her husband died young.”
Along with preventing thalidomide birth defects, Kelsey’s work provided “the turning point” for the notion that the womb was an impermeable protection for the fetus, Warsh said.
“She was so ahead of her time. We have to be proactive with the medical profession and with the pharmaceutical companies about what we are told and what we put into our bodies.”
Kelsey officially retired from the FDA in 2005, three years after she broke her hip, said Christine Kelsey.It had taken three years to use up all her accumulated sick leave. “She loved, loved her work. That was her passion.”
Her older daughter, Susan Duffield, who lives in Washington state, inherited her mother’s scientific mind and taught high school science until retirement. Last year, Warsh met Kelsey for a four-hour interview in her home in Washington D.C. “She’s quite a personality. She wore me out.” In hospital, she likes to be called “doctor,” not Frances. But she’s softening, Christine Kelsey said.
Kelsey moved to Christine’s home in London a month ago from Washington, D.C.
Christine, a retired physiotherapist, says her mother is content sitting by the large window, doing the odd crosswordand watching the birds and cats. “She’s very happy.”Kelsey was last in Cobble Hill in 1995, but hasn’t forgotten her idyllic Island home. Asked if she would like to visit, Kelsey didn’t hesitate. “I sure would,” she said.