Bart’s Corner: In Memoriam Dr. Kelsey

Sep 10, 2015
Bart Cobert

Pharmacovigilance, Drug Safety and Regulatory Affairs Author & Expert

In Memoriam – Frances Kelsey, MD, PhD, 1914-2015

Dr. Kelsey was born in Canada and did her training there and in the US.  After working as a general practitioner, she joined the US FDA as a medical reviewer and ultimately rose to very senior positions. One of her major achievements, for which she is remembered, is summarized as follows from her biographical sketch.

“Dr. Frances Kelsey took her stand against thalidomide during her first month at the Food and Drug Administration [in 1960], on her first assignment. The task was supposed to be a straightforward review of a sleeping pill already widely used in Europe, but Kelsey was concerned by some data suggesting dangerous side effects in patients who took the drug repeatedly. While she continued to withhold approval, the manufacturers tried everything they could to get around her judgment.

In November 1961, reports began to emerge in Germany and the United Kingdom that mothers who had taken thalidomide during pregnancy were now having babies with severe birth defects. Dr. Helen Taussig learned of the tragedy from one of her students and traveled to Europe to investigate. By testifying before the Senate, Taussig was able to help Kelsey ban thalidomide in the United States for good. At least 4000 children in Europe were affected by the drug, but thanks to Kelsey’s rigorous professionalism a similar tragedy was averted here in America.”

Or as the NY Times put it, somewhat more dramatically:

“The drug had already been sold to pregnant women in Europe for morning sickness, and the application seemed routine, ready for the rubber stamp. But some data on the drug’s safety troubled Dr. Frances Oldham Kelsey…Thus began a fateful test of wills. Merrell [the pharma company] responded. Dr. Kelsey wanted more. Merrell complained to Dr. Kelsey’s bosses, calling her a petty bureaucrat. She persisted. On it went. But by late 1961, the terrible evidence was pouring in. The drug — better known by its generic name, thalidomide — was causing thousands of babies in Europe, Britain, Canada and the Middle East to be born with flipperlike arms and legs and other defects.

Dr. Kelsey, who died on Friday at the age of 101, became a 20th-century American hero for her role in the thalidomide case, celebrated not only for her vigilance, which spared the United States from widespread birth deformities, but also for giving rise to modern laws regulating pharmaceuticals.”

She was awarded the President’s Award for Distinguished Federal Civilian Service by President Kennedy and she received the insignia of Member of the Order of Canada amongst other awards and honors.

A true hero.

Rest in Peace.

Tags: , ,