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The American Food and Drug Administration (FDA) first recruited Frances Oldham Kelsey in the autumn of 1960.
Little did anyone know that before long this young Canadian recruit would prove to be its most important asset.
While Kelsey was a fresh hire, she had already dabbled in science for quite a while now.
She graduated from high school at age 15 and then enrolled in Montreal’s McGill University where she completed a master’s degree in pharmacology.
Finding few job opportunities in Canada, she left for the United States and applied for a researcher’s position at the University of Chicago.
A sign of the male-dominated times was that her acceptance letter was mistakenly addressed to Mr Oldham.
Kelsey jested that if she had a less gender-neutral name, she would never have been hired at all.
Her application was accepted nonetheless and she began conducting research into how drugs interact with foetuses.
Hence, when she first joined the FDA’s ranks, she was already a veteran in science. Being a fresh recruit, she was first given what was seemingly an easy task.
All she had to do was review an application for a drug that was planned to be sold in the United States.
The US drug company Merrell marketed thalidomide, a German-developed sedative that was used worldwide to treat insomnia and reduce stress. Pregnant women frequently used thalidomide to treat morning sickness.
As Kelsey looked through Merrell’s application, she was dissatisfied with the lack of information on how the drug was absorbed in the body and its toxicity levels.
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While today’s FDA takes the effects of drugs on a foetus into consideration, safety standards back then were lax.
The placenta was believed to adequately protect developing foetuses from drug side effects.
Kelsey had research to prove otherwise, that the drugs a mother takes will affect her foetus through the placenta.
Thalidomide had not been tested on pregnant animals as Merrell was not inclined to do so.
Kelsey later said that Merrell’s evidence for the safety of its drug seemed less research and more a testimonial.
She promptly rejected its application and told it to come back with better evidence, a decision supported by the FDA.
Her action irritated the company, as it hadn’t expected any objection and had planned to sell the drug during the holiday season to make a higher profit.
Instead of giving her the evidence she asked for, company representatives visited and called her, trying to convince her into approving their application.
When she reiterated that she wanted proof of the drug’s safety, Merrell executives accused her of being nit-picky over minute details. She was the problem, not the drug, they said.
The FDA again thankfully supported Kelsey and Merrell sent further applications, all flawed and promptly rejected.
Her rejection proved justified, as news began to emerge that thalidomide was not so much a wonder drug as a cursed poison.
Side effects of nerve damage were dwarfed by the horrific birth defects caused when thalidomide is consumed by pregnant women.
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Thousands of foetuses died, and those that survived were born with extra digits, shorter limbs or lacked limbs completely.
Even as thalidomide sales halted in Germany, Merrell was still trying to sell the drug in the United States.
It finally gave up after Kelsey shot down its sixth and last application.
Many scientists worked hard to prove the danger of thalidomide, but it was Kelsey who prevented its entry into the lucrative American drug market.
As it became clear just how lucky the American public was in dodging the thalidomide bullet, Kelsey was rocketed into well-deserved stardom.
She was called a hero and in 1962, President John F Kennedy awarded her the President’s Award for distinguished federal civilian service.
Her experience with thalidomide led to reforms that ensured future drug application reviews would be more stringent.
She continued her work into her nineties and lived long enough to see that her legacy had left a positive impact on drug safety.
On Aug 7, 2015, she passed away peacefully less than a day after being presented with the insignia of Member of the Order of Canada. She was 101.
If not for her persistence on evidence-based facts, countless lives would have been lost or adversely affected.
On this International Day of Women and Girls in Science, FMT salutes Kelsey and women like her whose contributions to science continue to save lives to this day.
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