The very real story of how one woman prevented a national tragedy by doing her job
Dr. Frances Oldham Kelsey had only been with the Food and Drug Administration for about a month when she was tasked with reviewing a drug named thalidomide for distribution in America.
When Chemie Grünenthal released thalidomide in West Germany years earlier, they called it a " wonder drug " for pregnant women. They promised it would treat anxiety, insomnia, tension, and morning sickness and help pregnant women sleep.
In 1961, the health effects of thalidomide weren't well-known. Only a few studies in the U.K. and Germany were starting to connect the dots between babies born with physical defects and the medication their mothers had taken while pregnant.
Over the next year, the manufacturer would resubmit its application to sell thalidomide six times. Each time, Kelsey asked for more research. Each time, they refused.
Through dogged persistence, Kelsey and her team had prevented a national tragedy.
“I know that we are all most indebted to Dr. Kelsey. The relationship and the hopes that all of us have for our children, I think, indicate to Dr. Kelsey, I am sure, how important her work is and those who labor with her to protect our families. So, Doctor, I know you know how much the country appreciates what you have done."
But, she wasn't done yet. Later that year, the FDA approved new, tougher regulations for companies seeking drug approval, inspired in large part by Kelsey's work on thalidomide.
Bureaucratic approval work is rarely thrilling and not often celebrated. That's a shame because it's so critical.