WASHINGTON, Aug. 8 (UPI) — Much-maligned at the start of her career in the federal workforce, but retired a hero, Dr. Frances Oldham Kelsey was inspiration. She died on Friday, August 7, in London, Ontario, with her daughter by her side. She was 101.
It’s likely thousands of babies were saved thanks to the keen insight and strong backbone of Dr. Kelsey, a South Dakota family doctor who in 1960 became the new medical officer at the Food and Drug Administration.
Her new job required her to review requests for new drug licenses. One of the first applications on her desk was for a sedative called Kevadon, prescribed to pregnant women with morning sickness. It’s key ingredient was thalidomide.
The drug had already been prescribed to thousands of women in Europe and elsewhere, but the details of some the drug’s safety data didn’t seem right to Dr. Kelsey. She declined to approve the drug, and asked for further safety testing.
Drug companies painted her as a petty, nit-picking bureaucrat. But she stood her ground. And soon, evidence of the drug’s risks came flooding in from Europe.
Thousands of babies died in the womb, with some 10,000 more born with missing or deformed limbs — arms and legs resembling the flippers of a seal.
She was not alone in her fight. Physicians and pharmacologists around the world, as well as inside the FDA, worked to reveal the deadly effects of thalidomide. But she became the figure at the center of the drama, and she shouldered that responsibility with steely reserve.
“Her exceptional judgment in evaluating a new drug for safety for human use has prevented a major tragedy of birth deformities in the United States,” President John F. Kennedy remarked at a White House ceremony, at which Dr. Kelsey was given a distinguished federal civilian service award.
Inspired by the drama, regulators created a new branch of the FDA in 1962 for the testing, analysis and approval of new drugs. Dr. Kelsey was put in charge.
“She had a huge effect on the regulations adopted in the 1960s to help create the modern clinical trial system,” Daniel Carpenter, a professor of government at Harvard University and author of a book on the history of the FDA, told the Washington Post. “She may have had a bigger effect after thalidomide than before.”