Frances Oldham Kelsey
Introduction:
This is an interesting story of how one scientist avoided a national health disaster and the name of the scientist is Frances Oldham Kelsey.
Kelsey's teenage:
While she was 15 years old, she graduated from her high school. She officially registered at McGill University in Montreal and deserved both UG and master's degrees in pharmacology.
Kelsey as faculty:
After acquiring master's degrees she applied for a research post at the university of Chicago's pharmacology department. Her acceptance letter was addressed to her husband. Her career might have ended there but fortunately, it didn't. She earned her doctorate in pharmacology and accepted Chicago's invitation to stay as faculty.
Food & Drug Administration's zero fresher:
As a faculty she undertook pioneering research on drugs and fetal safety. In 1950, she earned an MD, fourth and final degree. By the time she joined the FDA (Food & Drug Administration), with no experience but she was one of the most educated scientists around. Yet as the newest member of the team, she proved herself as the best.
Thalidomide:
US drug company Merrell sent an application to sell a drug called thalidomide. It was a sedative developed in Germany that was already being widely used in dozens of countries to heal insomnia and workplace stress. Thalidomide's anti-nausea properties also made it a popular medicine for pregnant women with morning sickness.
Kelsey's rejection:
After reviewing Merrell's application, Kelsey found its data on thalidomide's absorption, toxicity and low quality. Today, the FDA classifies drugs based on their safety for a fetus. But in 1960, many experts believed that the placental barrier protected a fetus from harm. Kelsey's earlier animal-based research proved the opposite i.e. drugs could pass from mother to fetus through the placenta. Like other drug companies at this time, Merrell had not tested its drug on pregnant animals. So Kelsey rejected Merrell's application and asked them to submit a second supported by better evidence. Her FDA colleagues supported this decision.
Big disappointment:
Merrel had expected a quick, positive reply so it could launch thalidomide for the holiday season, when there is a down in sedative sales. Instead of supplying Kelsey with the data she requested they first tried to convince her to approve the drug over a series of calls and visits. When these failed to shake her, Merrel executives complained that stubborn and fussy Kelsey was the problem, not thalidomide. The FDA supported Kelsey, forcing Merrel to file another application,another and another.
Harmful Side effects of thalidomide:
As Kelsey reviewed and rejected each new application, news of thalidomide's harmful side effects began to surface. In early 1961, Doctors reported cases of nerve damage and by fall, they'd unmasked a more horrible truth. It, widely used by pregnant women, caused severe birth defects. Thousands of babies died in utero, more were born with extra appendages, shorter limbs or no limbs at all.
Media senstation:
In November 1961, thalidomide was pulled from the German market. But Merrell continued trying to get it approved in the US for several months before withdrawing their sixth and final application. Kelsey sounded the alarm that kept it off the multi-billion dollar American drug market. As public awareness of the thalidomide tragedy grew, the quiet scientist became a media sensation. Headlines in newspapers and magazines heralded her heroism while a smiling president John F. Kennedy presented her an award on the white house lawn.
Inspiration:
After that she headed the agency's drug investigation branch. Her visibility may have dimmed since, but her legacy endures. She made evidence based medicine the foundation of reforms that continue to protect people today. I'm inspired by Frances Kelsey's story and I hope you are too.
"Women are the real architects
of society.👸"
