Frances Oldham Kelsey, the Canadian doctor whose vocal opposition to the anti-nausea drug thalidomide helped keep it out of the United States, has died at age 101.
Kelsey, who was born on Vancouver Island, died early today with her daughter, Christine Kelsey, by her side. The two had been living in London, Ont.
Thalidomide was prescribed to pregnant women in the 1960s before it was discovered that it caused serious birth defects such as missing limbs, internal organ damage, deafness and blindness.
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Kelsey was a reviewer for the U.S. Food and Drug Administration who raised serious concerns about the safety of the drug.
Ontario Lt.-Gov. Elizabeth Dowdeswell had travelled to London on Thursday afternoon to present Kelsey with the Order of Canada, which was bestowed on her in the spring.
Dowdeswell suspects that because Kelsey lived in the U.S. for much of her life, it took longer for her to be honoured in Canada.
"She only came back last November, I believe, so that may have played a part in it," Dowdeswell said. "But the point is that the country did recognize her."
Dowdeswell said it was a privilege to present Kelsey with the medal.
"We knew that death was imminent, and I sat beside her bed, held her hand, told her why I was there and why it was so important that we have the opportunity to recognize her, and took the medal and had an opportunity to put it in her hands," Dowdeswell said.
"She immediately woke up and she was clearly aware that I was there. She didn't speak but she tried to speak and she got animated immediately. It was just such an honour. This was a person who dedicated her life to public service and for me to be able to say words of thanks, words of gratitude, it was so important to her family."
Daughter Christine Kelsey was at the bedside when her mother received the medal.
"Her family upbringing gave her the strength of her own convictions and her education gave her the understanding of the importance of careful research," Kelsey said from London, Ont.
Instrumental in licensing protocols
Throughout her career, Kelsey helped to improve pharmaceutical oversight procedures in the U.S., Gov. Gen. David Johnston's office said Thursday.
Thalidomide, first synthesized in West Germany by Chemie Gruenenthal, was marketed from 1957 in West Germany and under different names until the early 1960s. It was used to alleviate morning sickness in pregnant women around the world, including in Canada.
The drug was withdrawn from the West German and U.K. markets by December 1961, but remained available for use in pregnancy in Canada until March 2, 1962, according to the Thalidomide Victims Association of Canada.
Kelsey's refusal to agree with approval of the drug for use in the U.S. saved thousands of children from serious birth defects, and led to new safety standards for prescription drugs, a statement from the Governor General said. Only 17 children were born in the U.S. with thalidomide problems.
"Over the next four decades, she remained an instrumental figure in shaping and enforcing drug licensing protocols," it said.
In the early 1960s, CBC's Knowlton Nash talked to Kelsey about the pressure she faced from U.S.-based drug company William S. Merrell to approve it.
"Usually the companies are eager to get it on," Kelsey replied. "It's just a matter of when the pressure becomes excessive, our judgment may be interfered with."
'She was a hero'
Kelsey was hailed as a hero in the U.S. and given the President's Award for Distinguished Federal Civilian Service by John F. Kennedy.
But the drug's dark legacy continues in her home country: In May, the federal government announced Canada's nearly 100 thalidomide survivors will be each provided pensions of up to $100,000 a year for the rest of their lives. The aging survivors are seeking help to cope with their day-to-day needs.
Kelsey demonstrated how one person can change the world, said Alvin Law, a thalidomide survivor, currently in Crystal Lake, Sask.
"She was a hero. She was just simply that. She was a guiding angel. She was an amazing human being," Law said.
"She stood up to a lot of people and made us as a group have more relevance.… We weren't mistakes, we were human beings."
Through Kelsey's actions, not only did regulation of the pharmaceutical industry change, but she changed our mindsets about women taking drugs during pregnancy, he said.