In 1960, Dr. Frances Kelsey was only a month into her job at the Food and Drug Administration when she was asked to sign off on a drug providing relief to morning sickness in pregnant women.
The drug was already in use in countries around the world and the drug company insisted it was safe. But Kelsey believed that not enough research had been done and blocked its sale in the U.S., refusing to give in to hardball corporate pressure.
The drug was thalidomide, later blamed for dire birth defects in thousands of babies, many of whom were born with deformed or missing arms and legs.
The Canadian-born Kelsey, 101, whose stance not only blocked the drug in the U.S. but also helped bring about changes in FDA regulations, died Friday at the home of her daughter, Christine Kelsey, in London, Ontario, of age-related conditions.
She died only a day after being presented with the Order of Canada for "outstanding achievement, dedication to the community and service to the nation."
Kelsey may have never gotten to do her crucial work at the FDA if not for a mistake about her gender when she was a student at McGill University in Montreal. She was known then by her maiden name, Frances Oldham, and in 1936 wrote the head of a new pharmacology department at the University of Chicago, asking if there was a research assistant position available. To her surprise, she got a return letter offering her the job.
One problem: The letter to her began, "Dear Mr. Oldham."
"I knew that men were the preferred commodity in those days," she wrote in a personal history that's on the FDA website. "Should I write and explain that Frances with an 'e' is female and with an 'i' is male?"
A senior colleague told her to just accept the job, which she did. "To this day, I do not know if my name had been Elizabeth or Mary Jane, whether I would have gotten that first big step up."
It eventually led her to the FDA, which in 1960 had only about a dozen medical officers assigned to review drug applications. Thalidomide, billed as a sedative and originally formulated in Germany, did not seem as if it would pose major problems — the manufacturer said it had been tested with virtually no ill effects.
"I was the newest person there," Kelsey wrote, "so my supervisors decided, 'Well, this is a very easy one. There will be no problems with sleeping pills.'"
She was not the only one at the FDA, however, to have qualms about the drug. Colleagues in the agency's chemistry and pharmacology departments also raised concerns. But she had the chief objections, much to the frustration of the Richardson-Merrell drug company, which was seeking thalidomide's approval.
Kelsey believed the company had not been completely forthright about side effects, which alarmed her at a time when there was evidence that effects could be far more severe on the unborn than on the mother.
The company, which had expected a near-rubber stamp approval, pressed on, complaining to her superiors and directly to her. "They were writing letters and telephoning," she told Investor's Business Daily in 2001. "They were very anxious to get their product on the market. It had been very successful in other countries and they felt there would be a big market in this country."
But she maintained that proper testing had not been done and refused to be moved.
"Then quite suddenly," she wrote in the FDA essay, "the news came from Europe about the deformities."
Babies were being born with severely shortened, flipperlike limbs and other deformities, eventually tied to the mothers having taken thalidomide.
In spring 1962, Richardson-Merrell withdrew its U.S. application and the drug was pulled worldwide. But an estimated 10,000 babies in more than 40 countries were born with deformities.
One of them was Randy Warren of Canada, Kelsey's home country, which had approved the drug.
"She says she was just doing her job," Warren said of Kelsey in a 2001 Investor's Business Daily interview. "Well, we worship her here."
She was born on July 24, 1914, in a rural area near the community of Cobble Hill on Vancouver Island. Growing up, she had a notion that she wanted to study biology, but few girls from her area went to college. "Some of them went for a year or two," Kelsey wrote, "admittedly for the social life."
As she did in many areas, she bucked the trend, earning her bachelor's and master's degrees in science from McGill, then her Ph.D. and M.D. at the University of Chicago.
At that university she met instructor F. Ellis Kelsey, and they were married in 1943.
He died of a heart attack in 1960. Frances Kelsey is survived, in addition to her daughter Christine, by daughter Susan Duffield, sister Monica Oldham and two grandchildren.
Kelsey worked for the FDA until she retired in 2005 at 90.
Her most lasting legacy, in addition to the unknown number of babies saved from dire conditions, is the Kefauver-Harris Amendment to the 1938 Food, Drug and Cosmetic Act, which was approved in 1962 largely because of what happened with thalidomide. It greatly tightened regulations for the approval of drugs.
That same year Kelsey became the second woman to receive the President's Distinguished Federal Civilian Service Award.
"The relationship and the hopes that all of us have for our children," President John F. Kennedy said in bestowing the award, shows "how important her work is and those who labor with her to protect our families.
"So, Doctor, I know you know how much the country appreciates what you have done."