Frances Oldham Kelsey died yesterday. Never heard of her? If you’re under 55, she may have saved your life. In fact, her work changed the lives of millions of Americans born after 1962.
Dr. Kelsey had just taken a job as the newest medical officer at the U.S. Food and Drug Administration in 1960. She was one of just seven full-time and four part-time physicians reviewing drugs for the FDA. A month into her new job, she was handed a review file for a drug that was already widely in use across Europe, Canada, and South America as a sleep aid. Added benefits – it provided pregnant women relief from morning sickness and was completely non-addictive. The Richardson-Merrell pharmaceutical company of Cincinnati was applying to introduce the drug in the U.S. under the commercial name Kevadon. Its clinical name was thalidomide.
The decision should have been easy. In fact, Dr. Kelsey later speculated that they’d given her the file precisely because she was new, and it was a simple approval for a sedative. The drug was already in use around the world, it just needed approval in the U.S. But Dr. Kelsey wasn’t satisfied with the level of research in the file; she would later note that “The clinical reports were more on the nature of testimonials, rather than the results of well-designed, well-executed studies.” At that time, a drug company could push a drug to market 60 days after an application was filed with the FDA, and manufacturers often supplied experimental drugs to doctors and encouraged them to try them out on patients. Dr. Kelsey kept requesting more information from the manufacturer, and each time she did, the 60 day clock was re-set, further delaying release of the drug. The company representative began to grow frustrated, calling Dr. Kelsey regularly and eventually, her supervisors, to complain that she was nit-picky, and unnecessarily delaying the release of the drug.
Dr. Kelsey kept pushing back. For 19 months she kept at it, asking more questions, conducting more research, and absolutely refusing to approve the use of thalidomide in the U.S. until she was satisfied. Meanwhile, in Europe, physicians began to see a disturbing trend in new births: babies born with deformed limbs, toes and fingers sprouting directly from hip and shoulder joints, malformed internal organs, and defects of the ears and eyes. Miscarriages and early infant deaths were occurring everywhere. The cause wasn’t clear at first, but by late 1961, it was obvious – 50% of deformities were occurring when mothers took thalidomide in the first trimester of pregnancy.
Dr. Kelsey’s demand for sound research and an evidence-based approval process ultimately saved thousands of children in the U.S. from deformity or death, and the long-term effects were even more profound. The attention that she brought to the process sparked a change in drug evaluations and approvals for market in the U.S. After 1962, Congress took a much more active oversight role of FDA processes, enacting tougher regulations, and demanding greater accountability from both the agency and drug manufacturers. Those regulations have changed life for all of us born after the thalidomide scandal. In fact, there are many of us who might not be alive today were it not for Dr. Kelsey and her work.
There are a great many lessons to learn from Dr. Kelsey’s story. But the one I’ve been thinking about today is her role as an ethical leader in government. She did what she believed was right, continuing her research, focusing on excellence, in spite of accusations that she was just another nitpicking bureaucrat standing in the way of progress. Her work wasn’t particularly ground-breaking or exciting; she just built on research that she and others had already done. But she did her work well, she stood her ground, and her tenacity changed the health and well-being of millions of Americans.
We talk a lot about the men and women that we elect to political office, about their influence, their power, the good they do, and the mistakes they make. But as much as we need solid, ethical leaders in politics, we also need a cadre of regular government employees who are dedicated, who make wise decisions, and who strive to do what’s right over a lifetime of government service. So, a little appreciation today for bureaucrats everywhere, especially those in the spirit of Dr. Kelsey.
Dr. Kelsey was a recipient of the President’s Award for Distinguished Federal Service in 1960, the Gold Key Award from the University of Chicago, Medical and Biological Sciences Alumni Association, the Foremother Award from the National Research Center for Women & Families, and an honorary doctor of science degree from the Vancouver Island University in 2012. A dual citizen of the U.S. and Canada, she was inducted into the U.S. National Women’s Hall of Fame in 2012, and named to the Order of Canada in 2015.