In the autumn of 1960, Frances Oldham Kelsey joined the Food and Drug Administration (FDA) as one of its newest recruits. By the end of that year, she embarked on a mission that would ultimately save thousands of lives, although this was not apparent at the time. Kelsey was far from inexperienced; she had graduated high school at the age of 15 and went on to earn both undergraduate and master’s degrees in pharmacology from McGill University in Montreal. Her journey in science continued when she applied for a research position at the University of Chicago’s pharmacology department. Interestingly, her acceptance letter was mistakenly addressed to Mr. Oldham, a mistake she later joked about, suggesting that if her name had been more common, her career might have ended there. Fortunately, it didn’t. She earned a doctorate in pharmacology and accepted a faculty position at Chicago, where she conducted groundbreaking research on drugs and fetal safety. By 1950, she had also earned an MD, making her one of the most educated and experienced scientists by the time she joined the FDA.
As the newest member of the FDA team, Kelsey was given what seemed to be a straightforward task: reviewing an application from the US drug company Merrell to market a drug called thalidomide. Thalidomide, a sedative developed in Germany, was already widely used in many countries to treat insomnia and workplace stress. Its anti-nausea properties made it particularly popular among pregnant women suffering from morning sickness. However, upon reviewing Merrell’s application, Kelsey found the data on thalidomide’s absorption and toxicity to be insufficient. At that time, many experts believed that the placental barrier protected a fetus from harm, but Kelsey’s previous animal research had shown otherwise: drugs could indeed pass from mother to fetus through the placenta. Like many other drug companies, Merrell had not tested thalidomide on pregnant animals. Kelsey later commented that Merrell’s evidence for the drug’s safety seemed more like testimonials than results from well-designed studies.
Kelsey rejected Merrell’s application and requested a resubmission with more robust evidence. Her colleagues at the FDA supported her decision. Merrell had anticipated a swift approval to launch thalidomide during the holiday season, a peak time for sedative sales. Instead of providing the requested data, Merrell attempted to persuade Kelsey to approve the drug through numerous calls and visits. When these efforts failed, Merrell executives claimed that Kelsey was the problem, not thalidomide. The FDA stood by Kelsey, compelling Merrell to submit multiple new applications. As Kelsey reviewed and rejected each one, reports of thalidomide’s adverse side effects began to emerge. By early 1961, cases of nerve damage were reported, and by fall, a more alarming truth surfaced: thalidomide, widely used by pregnant women, was causing severe birth defects. Thousands of babies died in utero, and tens of thousands more were born with serious deformities.
In November 1961, thalidomide was withdrawn from the German market. Despite this, Merrell continued to seek approval in the US for several more months before finally withdrawing their last application. While Kelsey was not the only scientist to recognize the dangers of thalidomide, she played a crucial role in preventing its approval in the American market. As public awareness of the thalidomide disaster grew, Kelsey became a media sensation. Newspapers and magazines celebrated her heroism, and President John F. Kennedy awarded her on the White House lawn. Following the thalidomide scare, Congress passed laws that expanded the FDA’s authority and strengthened requirements for new drug applications. Kelsey was appointed to lead the agency’s drug investigation branch. She continued to work at the FDA in various roles well into her 90s, witnessing the changes her actions helped bring about. Although her visibility may have faded over time, her legacy remains. By prioritizing facts over opinions and patience over shortcuts, she laid the foundation for evidence-based medicine, reforms that continue to protect people today.
Engage in a role-playing debate where you take on the roles of Frances Oldham Kelsey, Merrell executives, and FDA colleagues. Discuss the ethical and scientific considerations involved in the approval process of thalidomide. This will help you understand the complexities of drug approval and the importance of evidence-based decision-making.
Analyze the thalidomide case study in small groups. Identify the key factors that led to the prevention of a national health crisis. Discuss how Kelsey’s actions influenced modern drug regulations and the role of scientific integrity in public health. Present your findings to the class.
Conduct research on another historical case where scientific diligence prevented a potential health crisis. Prepare a presentation that compares and contrasts this case with Kelsey’s handling of thalidomide. Highlight the lessons learned and their implications for current scientific practices.
Create an interactive timeline that details the events leading up to and following the thalidomide crisis. Include key dates, decisions, and outcomes. Use this timeline to discuss how timely actions and decisions can impact public health policy and safety.
Participate in a workshop focused on ethical decision-making in scientific research and drug approval. Use Kelsey’s story as a case study to explore the ethical dilemmas faced by scientists and regulators. Develop a set of guidelines for ethical practices in the pharmaceutical industry.
In the fall of 1960, Frances Oldham Kelsey was one of the Food and Drug Administration’s newest recruits. By the end of that year, she would begin a fight that would save thousands of lives, though no one knew it at the time. Kelsey was no novice as a scientist; after graduating from high school at age 15, she enrolled at McGill University in Montreal and earned both undergraduate and master’s degrees in pharmacology. She then applied for a research position at the University of Chicago’s pharmacology department, where her acceptance letter was mistakenly addressed to Mr. Oldham. Kelsey later joked that had her name been more common, her career might have ended there. Fortunately, it didn’t. She earned her doctorate in pharmacology and accepted Chicago’s invitation to stay as faculty, where she undertook pioneering research on drugs and fetal safety. In 1950, she earned an MD, her fourth and final degree. By the time she joined the FDA, Frances Kelsey was one of the most educated and experienced scientists around.
As the newest member of the team, Kelsey was assigned what everyone thought would be an easy review: an application from the US drug company Merrell to sell a drug called thalidomide. Thalidomide was a sedative developed in Germany that was already being widely used in dozens of countries to treat insomnia and workplace stress. Its anti-nausea properties also made it a popular remedy for pregnant women with morning sickness. However, while reviewing Merrell’s application, Kelsey found its data on thalidomide’s absorption and toxicity inadequate. At that time, many experts believed that the placental barrier shielded a fetus from harm, but Kelsey’s earlier animal-based research demonstrated the opposite: drugs could pass from mother to fetus through the placenta. Like other drug companies, Merrell had not tested its drug on pregnant animals. Kelsey later remarked that Merrell’s evidence for thalidomide’s safety seemed “more like testimonials than the results of well-designed studies.”
Kelsey rejected Merrell’s application and requested a second submission backed by better evidence. Her FDA colleagues supported this decision. Merrell had expected a quick approval so it could launch thalidomide for the holiday season, when sedative sales soar. Instead of providing the requested data, they first tried to convince Kelsey to approve the drug through a series of calls and visits. When these attempts failed, Merrell executives complained that Kelsey was the problem, not thalidomide. The FDA backed Kelsey, forcing Merrell to file multiple new applications. As Kelsey reviewed and rejected each new application, reports of thalidomide’s adverse side effects began to surface. By early 1961, doctors reported cases of nerve damage, and by fall, a more horrifying truth emerged: thalidomide, widely used by pregnant women, caused severe birth defects. Thousands of babies died in utero, and tens of thousands more were born with serious deformities.
In November 1961, thalidomide was pulled from the German market. Nonetheless, Merrell continued trying to get it approved in the US for several months before withdrawing their final application. While Kelsey wasn’t the only scientist to identify the risks of thalidomide, she was instrumental in keeping it off the 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, and a smiling President John F. Kennedy presented her with an award on the White House lawn. After the thalidomide scare, Congress passed laws that expanded the FDA’s authority and toughened requirements for new drug applications. Kelsey was tapped to head the agency’s drug investigation branch. Working at the FDA in various capacities into her 90s, Kelsey was able to witness the changes her actions helped inspire. Though her visibility may have dimmed since, her legacy endures. By privileging facts over opinions and patience over shortcuts, she made evidence-based medicine the foundation of reforms that continue to protect people today.
Science – The systematic study of the structure and behavior of the physical and natural world through observation and experiment. – Science has provided us with a deeper understanding of the universe and the laws that govern it.
Health – The state of being free from illness or injury, encompassing physical, mental, and social well-being. – Maintaining good health is essential for a productive and fulfilling life.
Pharmacology – The branch of medicine and biology concerned with the study of drug action on biological systems. – Pharmacology plays a crucial role in the development of new medications and therapies.
Thalidomide – A drug that was originally used as a sedative and later found to cause birth defects, leading to stricter drug regulations. – The thalidomide tragedy of the 1960s led to significant changes in drug safety testing and approval processes.
Safety – The condition of being protected from or unlikely to cause danger, risk, or injury. – Ensuring the safety of new pharmaceuticals is a top priority for regulatory agencies.
Research – The systematic investigation into and study of materials and sources in order to establish facts and reach new conclusions. – Research in the field of genetics has led to groundbreaking discoveries in personalized medicine.
Evidence – The available body of facts or information indicating whether a belief or proposition is true or valid. – Scientific evidence is essential for validating the efficacy of new treatments.
Drugs – Substances used in the diagnosis, treatment, or prevention of disease and as components of medication. – The development of new drugs requires rigorous testing to ensure their safety and effectiveness.
FDA – The Food and Drug Administration, a federal agency responsible for protecting public health by ensuring the safety, efficacy, and security of drugs, biological products, and medical devices. – The FDA plays a critical role in the approval process for new pharmaceuticals entering the market.
Pregnancy – The condition or period of being pregnant, involving the development of an embryo or fetus within the female body. – Certain medications must be carefully evaluated for their safety during pregnancy to prevent adverse effects on the developing fetus.
