HISTORY | MEDICINE
The Woman Who Prevented a National Health Crisis
‘Thalidomide’ would have caused an epidemic of birth defects if not stopped in the early 1960s
In the history of modern medicine, this story created global terror. Its after-effects were so tragic that thousands of children died in their mothers’ wombs and many others were born with deformities in several other parts of the country. Some of the children were found armless, legless, and the rest of their organs prematurely failed to develop. It brought about a range of impairments in the children.
The tragedy can be considered as anathema to humankind. By late 1961, scientists discovered the cause behind the children’s misfortunate congenital disabilities and their upsurged mortality rate. The root cause was thalidomide, a commercially distributed drug that was available worldwide.
Fortunately, the United States was blocked from this tragedy by the efforts of Frances Oldham Kelsey. Born in British Columbia, she graduated from high school at the age of fifteen. Afterward, she enrolled in McGill University in Montreal and obtained undergraduate and master’s degrees in Pharmacology.
From hereon, Frances Kelsey applied for a research post in the Pharmacology Department at the University of Chicago. Her acceptance letter was addressed to Mr. Oldham. She later joked that had if her name sounded feminine, her career might have ended there. This is because those times witnessed a fewer number of women in scientific fields. However, with merits standing on her side, Dr. Kelsey was shining bright even in her male-dominated profession.
Spending most of her youth in Canada, she studied, researched, and reviewed drugs. She got married to Fremont Ellis Kelsey, a fellow faculty member, and got blessed with two daughters. Dr. Kelsey was one of the most intellectual, educated, and experienced scientists in history.
In 1960, Frances Kelsey worked as a full-time medical officer for the Food and Drugs Administration (FDA) in Washington, D.C. There, she reviewed the safety of several drugs for the FDA.
In one of her initial assignments at the FDA, she reviewed an application from a U.S.-based drug company, Merrell, who presented a request plea to sell a drug called thalidomide, under the trade name Kevadon. The drug had been developed in Germany and was already being consumed worldwide as a painkiller against insomnia and work-related stress. The anti-nausea properties of the drug made it a highly popular sedative among pregnant women suffering from morning sickness.
After examination, Frances Kelsey rejected the application and alerted the authorities about the drug being toxic. Furthermore, she withheld the approval of the drug and advised that it required further research. The drug manufacturers rose in anger over her claims and started characterizing her as the nitpicker in the pharmaceutical industry.
Despite opposition, Frances Kelsey insisted that the drug should be thoroughly tested before its approval. Her claims were proven when the drug’s adverse effects began to appear in Europe, causing the death of the babies and prompting severe birth deformities in children. Another cause of her concern was that the company didn’t test the drug on pregnant animals before releasing it into the market.
During that time, experts believed that the placental barrier shielded the fetus from external damages. However, during Frances Kelsey’s medical career, she had observed that drugs could pass from the mother to the fetus through the placenta. After analysis, researchers were also convinced that the drug did cross the placenta, resulting in severe birth defects.
She stood her ground on Kevadon, child deformities, and fetal deaths in places where thalidomide was distributed. It was also found that a rare condition called phocomelia or amelia, which caused shortening of the limbs and which had previously affected millions of children, began to re-appear after the consumption of the drug.
With the tremendous support of researchers and her FDA colleagues, Dr. Kelsey was able to avert the tragedy in the United States. Globally, her efforts were hailed as praiseworthy, and in one article in the Washington Post, she got her deserved recognition. Due to her sheer dedication, stubbornness, and persistence, another American tragedy failed to occur.
Consequently, several legislation rules were formulated to strengthen drug regulation. This law came to be known as Kefauver-Harris Amendments or Drug Efficacy Amendment. It directed the pharmaceutical companies to determine the adequacy of drugs, report their adverse effects to the FDA, and obtain consent from people involved in drug testing. The rules also required prior testing before introducing the drugs into the market.
In 1962, President John F. Kennedy awarded Dr. Kelsey with the President’s Award for Distinguished Federal Civilian Service because of her efforts in preventing the thalidomide tragedy in America.
She had dual citizenship, one from Canada and the other from the United States, where she continued with her medicinal practice. Her meritorious efforts also granted her the honorary position of “chief” in the FDA’s drug investigational branch. A few years later, she became the director of the New Office of Scientific investigations and worked in different capacities until her nineties.
For several years, Dr. Kelsey remained a significant figure in the agency and played an important role in federal drug regulations and their safer approval. Dying at the age of a hundred and one, she left behind an inspirational legacy with innumerable teachings.
Privileging persistence over shortcuts and facts over opinions, Frances Kelsey’s research-based reforms in the field of medicine brought about life-changes, saved humankind, and served humanity at large.
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