Tawana Williams from Wilson USA, eats, writes, and bathes from her feet. She does not have a choice as she was born among 12, 000 babies affected by thalidomide which is today remembered widely as the thalidomide tragedy in the early 1960s. Among all this, a lady from the then Food and Drug Administration saved the US from a birth defects catastrophe. Frances Oldham Kelsey is the recipient of the highest recognition attainable for a US civil servant for her role in saving thousands of babies from death or life-long incapacitation.

Frances Oldham Kelsey, a Medical reviewer who managed to avert National health crises.

Frances Oldham Kelsey was one of the newest recruits of the Food and Drug Administration, and before the year was out, who knew this new young talent would save hundreds or perhaps thousands of lives? But despite being new at the FDA, Kelsey was a much educated and knowledgable scientist.

Frances Oldham Kelsey was born in Cobble Hill, Vancouver Island, B. C, and had an interest in science from an early age. She completed her graduation by the age of 15 years and then went on to pursue both a B.Sc.(1934) and an M.Sc.(1935) in pharmacology. She then wrote a letter to the University of Chicago, asking for a research post. The noted researcher who reviewed her profile thought that she was a man because of her first name Frances and thus gave her a job.

In 1936, she started working at the pharmacological department undertaking her research in drug and fetal safety. The same year she achieved her Ph.D. in pharmacology at the University of Chicago, her fourth and final degree. In 1942, while looking for a synthetic cure for malaria, Kelsey discovered that some drugs could pass through the placental barrier. This research proved very useful in her years at the FDA.

Frances Oldham Kelsey

In 1960, Oldham Kelsey was hired by the FDA in Washington, D.C. She was one of the most educated, researched, and experienced scientists at the center. However, though being only a fresher, Kelsey was assigned her first task of reviewing new drugs. Her first application was from US drug company Richardson-Merrell to sell a drug called Thalidomide. The drug was already in wide use in Germany for its usefulness in insomnia and work stress management. Its anti-nausea property also made it medicine for pregnant women’s morning sickness.

Despite thalidomide popularity in Canada and 20 European and African countries, Kelsey withheld the approval of the drug before any research. In the 1960s many scientists believe that the drugs could not pass through Placental barriers and thus approved thalidomide usage by pregnant women, however, Kelsey’s research stated that some drugs can pass through the placental barrier, and thus the drug shouldn’t be approved without adequate testing.

Merell had not tested the drug on pregnant animals and thus Kelsey asked for another revised application from the company. Kelsey rejected Merell’s application one by one because they were never fully adequate for commercial use. The company men however thought of a quick approval so that the drug could be commercialized before the holiday season in order to earn a good profit. Thus, instead of providing a piece of better-backed evidence, the company criticized her for being arrogant and stubborn.

They tried several times to convince her over calls and visits but it wasn’t enough for Kelsey to approve their drug. Despite Merell’s effort to nitpick Kelsey, the FDA supported her. They asked Merell to send another application yet none of them were approved by Kelsey as she saw them not safe enough for public use.

Amid all such chaos, news of thalidomide side effects began on the surface. Many doctors had recorded cases of nerve damage in 1961 and by the end of the year, Kelsey discovered something even more dangerous. Thalidomide which was widely in use by pregnant women resulted in severe birth deformities. Thousands of babies died inside Utero and the ones born were either had short limbs or no limbs at all. By the end of 1961, the drug was pulled out of German markets yet few countries still used it.

Frances Oldham Kelsey

Despite, the horrible side-effect of the drug, Merell continued its efforts to get the drug approved in the US. Though Kelsey and other FDA members stood still and Merell was forced to withdraw their sixth application. While Kelsey wasn’t the one to discover the side effects of Thalidomide, she was the one who alarmed and saved the US from a catastrophe that later went on to become the Thalidomide tragedy of the 1960s.

Kelsey was recognized and appreciated for her efforts to keep the drug off the American market. The public hailed her heroism and the media called her a savior. Frances Oldham Kelsey was awarded the President’s Award for Distinguished Federal Civilian Service by John F. Kennedy on 7 August 1962. She became the second woman to be honored with the title.

As an aftermath of the tragedy, Congress passed laws that expanded FDA’s authority over drug approval. Applicants have to submit more research-backed applications than ever before. Kelsey later went on to become the head of the FDA and continued her work in shaping and enforcing the 1962 amendments. She retired at the age of 90 in 2005, after 45 years of pure adventure and loyalty. To honor her bravery, in 2010, the FDA established the Kelsey Award.

Kelsey died on August 7, 2015, at the age of 101. Though the Americans today might not remember her efforts, Kelsey’s legacy continues to prevail. At the time, when women were still facing a ton of prejudice at work, the FDA could easily have pressured her to approve the drug, and she might’ve cracked under the pressure. However, their collective efforts averted a national health crisis. 

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