Frances Oldham Kelsey had recently been appointed to the Order of Canada, one of the country’s highest honours
She stalled a routine drug approval that could have resulted in thousands of disabled children being born in the US. Frances Oldham Kelsey had only just started working at the US Food and Drug Administration in 1960 when an approval request for thalidomide landed on her desk.
A PhD and medical doctor from the University of Chicago, Kelsey refused to approve its release in the US.
The drug was already widely used as a sleeping pill in Europe. But Kelsey had come across data which showed that patients who took the drug repeatedly suffered dangerous side effects.
As there was lack of clinical evidence about these side effects, Kelsey resisted pressure from the manufacturers and continued to withhold approval.
In 1961, the United Kingdom and Germany began reporting cases of women, who had taken thalidomide during pregnancy, giving birth to babies with defects.
Helen Taussig, an American paediatric cardiologist, went to Europe to investigate these cases. She confirmed that thalidomide had caused terrible deformities in children and testified to the US Senate. This evidence helped Kelsey stand by her decision to refuse approval to thalidomide and avert a tragedy in the US.
For her bold stand, Kelsey was given the President’s Award for Distinguished Federal Civilian Service in 1962 by the then president John F Kennedy. Kennedy acknowledged her contribution by stating that with “steadfast confidence” in her professional decision, “she has made an outstanding contribution to the protection of the health of the American people”.
Kelsey went on to become chief of the Division of New Drugs, director of the Division of Scientific Investigations, and deputy for Scientific and Medical Affairs, Office of Compliance of the US government.
She is credited with bringing about crucial amendments to FDA drug regulation laws to protect patients in drug investigations. With this, it became necessary to show drugs as both safe and effective. It also became necessary to obtain informed consent of patients in clinical trials.
Kelsey was born in District of Columbia in Canada in 1914. She died in Ontario on Friday, a day after a private ceremony was held to appoint her to the Order of Canada.
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