Frances Kelsey has a credo that has served her well through the years, and those years have stretched now to 100. Her voice strong and her gaze firm, she offers advice to those who might face adversity: "Just stick to your guns."
A half century ago, the Canadian-born Dr. Kelsey stuck to her guns. An entire country – the United States – was grateful.
As a medical officer at the U.S. Food and Drug Administration in Washington in the early 60s, Dr. Kelsey almost singlehandedly averted a public-health disaster in the U.S. by refusing to give the sedative thalidomide her blessing.
Canada – by contrast – approved the drug, and more than 100 babies were born with missing limbs and other severe deformities. As the now-adult Canadian victims turn to Ottawa for funding to help cope with the enduring ravages of the drug, the actions of a lone scientist in the U.S. highlight one public servant's steadfastness as much as another country's failings.
Dr. Kelsey is a Canadian heroine. But her heroism belongs to another country.
"I just held my ground. I wouldn't approve it," Dr. Kelsey says in an interview in her home in suburban Washington, filled with a lifetime's recognitions as well as mementos of her well-loved childhood in British Columbia.
Dr. Kelsey's resistance to the relentless pressures of the drug's manufacturer likely spared thousands of American families from tragedy. It also elevated Dr. Kelsey to one of the most celebrated civil servants in that country.
To thalidomide survivors in Canada, her vigilance bolsters their argument that the Canadian government was negligent about thalidomide and, in the group's eyes, still carries a moral responsibility for its victims.
The Thalidomide Victims Association of Canada has launched a campaign seeking federal financial support for the 95 survivors in the country, who are coping with growing health and care needs as they age.
"She was an example of rigour. It's as if we were wimps in Canada," says Mercédes Benegbi, head of the association. "On the basis of the same data, we said everything was perfect, while it was unacceptable in the U.S. Someone here didn't do their job."
Despite her accomplishments, Dr. Kelsey's story and her roots in Canada are little-known.
The daughter of a retired British army officer father and a Scottish-born mother, Frances Oldham grew up exploring the fields and shorelines around her home in Cobble Hill on Vancouver Island. It fed her love of science. A high-school teacher at Saint Margaret's School in Victoria spotted her talent. "Her scientific ability should be encouraged in every way," the teacher wrote in the student's 1930 report card.
Young "Frankie" left B.C. to get her undergraduate and masters degrees in science at McGill University in Montreal. When an opening appeared as a research assistant at the University of Chicago, her McGill professor urged her to apply. She was accepted after the U.S. professor mistook Frances for a man and addressed her in a letter as "Mr."
"To this day," Dr. Kelsey later said, "I do not know if my name had been Elizabeth or Mary Jane, whether I would have gotten that first big step up."
She got a medical degree, married fellow faculty member J. Ellis Kelsey, worked at the American Medical Association Journal and moved to Washington to take a job at the FDA.
Dr. Kelsey had been at work only a month in 1960 when she was handed the thalidomide file. Approval for the new "wonder" drug was supposed to be routine: By that time, thalidomide had been for sale in Europe for years as a supposedly safe sedative, prescribed to pregnant women for insomnia or nausea. The U.S. drug-maker, William S. Merrell Co. of Cincinnati, was impatient to see it approved in that country's expansive market.
"They figured it was so popular in Europe," Dr. Kelsey says, "so I would be a pushover."
But gaps in the firm's application bothered her. "The information as presented was very sketchy," she says today. She requested further evidence of the drug's safety. All the while, the drug company representatives kept phoning and writing her.
"The company wasn't happy with me. They thought I was being pretty stubborn," Dr. Kelsey says. "They just wanted to sell their drug."
Dr. Kelsey was unfazed. "I just didn't like it from the start. It was just too overblown. And they didn't have any evidence to submit. They were so sure it was good because of its popularity in England. They couldn't understand what I was fussing about."
Yet while her "fussing" kept the drug at bay in the U.S., Canadian officials at the Food and Drug Directorate in Ottawa appeared to show no such qualms. Merrell submitted its application to Canada and the U.S. within days of one another, using the same research data. Canada signed off on the drug. There was nothing to raise concerns, C.A. Morrell, head of the agency, later said.
By early 1961, Dr. Kelsey's doubts appeared justified. A letter to the editor appeared in the British Medical Journal in which a doctor linked thalidomide to painful tingling of the arms and feet.
Dr. Kelsey asked the drug company for more information, including evidence that thalidomide was safe to take during pregnancy. Her own training was invaluable: While researching antimalarial drugs during the Second World War, she found that quinine was able to cross the placental barrier in rabbits, and could not be broken down by the embryo.
Merrell representatives continued to press her, growing impatient to get the drug on the market for Christmas, which they said was a busy period for sedatives. Then, in late 1961, reports arrived from Europe of horrendous birth defects linked to thalidomide. Babies were born with flipper-like arms or no limbs at all. In November, Germany announced it was pulling the drug from the market. Britain followed.
Canada did not. The drug manufacturer did send a warning letter to doctors not to prescribe thalidomide to pregnant women, but Ottawa kept the drug on sale for three more months.
Dr. Kelsey, with modesty that would be familiar to Canadians, deflects the accolades about her contribution. "It was good luck and stubbornness," she says.
Others, however, recognize her deed. In 1962, she was invited to the White House south lawn to receive an award from President John F. Kennedy. It was a heady time in America. Astronauts John Glenn and Alan Shepard were there that day to get awards too.
Dr. Kelsey wore white gloves, and the President draped a medal around her neck. "It was a lovely day," she recalls, "and he was very handsome."
Her actions led to landmark new drug regulations in the U.S. In 2010, she was honoured by the FDA, which named a prize after her. President Barack Obama sent a message. "Our country relies on dedicated public servants like Dr. Kelsey to create a better, healthier future for our children and grandchildren," he wrote in a letter she keeps on a hallway table, near a 100th-birthday message from the Queen.
An object of admiration in her adopted home, Dr. Kelsey remains a virtual unknown in the country of her birth.
A high-school north of Victoria is named after her, and several Canadian universities have granted her honorary degrees. Yet she is mostly ignored.
Dr. Kelsey retains strong ties to Canada. She says she obtained dual citizenship in the mid-1950s only in order to practise medicine in the U.S. She has a sister in Victoria and one of her two daughters lives in London, Ont., where she visits regularly.
"I have the most happy memories of growing up in Canada," Dr. Kelsey says. She keeps a picture of her idyllic, broad-porched childhood home in Cobble Hill displayed prominently on the wall of her living room.
The Thalidomide Victims Association of Canada calls Dr. Kelsey an idol, someone who stood firm while Canada's drug watchdogs failed. For Canadian victims of thalidomide, this clear-voiced centenarian is the guardian angel they never had.