Trailer: The Devil in the Details
Digest
The episode begins by referencing a previous episode about a female paleontologist and recommends the "I Know Dino" podcast for listeners interested in paleontology. It then delves into the Thalidomide tragedy, a devastating event where thousands of babies in Europe were born with severe birth defects due to their mothers taking the drug Thalidomide during pregnancy. The episode highlights the crucial role of Francis Oldham Kelsey, an FDA reviewer who, despite pressure from the drug company, refused to approve Thalidomide in the United States. Her skepticism and thorough review, demanding further testing, ultimately prevented a similar tragedy from occurring in the US. The episode emphasizes Kelsey's dedication and the importance of rigorous scientific scrutiny in protecting public health.
Outlines
The Thalidomide Tragedy and Francis Oldham Kelsey
This episode discusses the Thalidomide tragedy, a drug that caused severe birth defects in thousands of babies in Europe. It highlights the role of Francis Oldham Kelsey, an FDA reviewer who prevented Thalidomide from being approved in the United States.
Keywords
Thalidomide
Thalidomide is a drug that was marketed as a safe sedative in the late 1950s. However, it caused severe birth defects in thousands of babies in Europe. It was never approved in the United States due to the efforts of Francis Oldham Kelsey.
Francis Oldham Kelsey
Francis Oldham Kelsey was an FDA reviewer who prevented Thalidomide from being approved in the United States. She was a skeptic and a nitpicker, but her actions saved countless lives.
FDA
The Food and Drug Administration (FDA) is a federal agency responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation.
Drug Safety
Drug safety refers to the evaluation and management of the risks associated with the use of drugs. It involves identifying potential adverse effects, minimizing risks, and ensuring that drugs are used appropriately.
Public Health
Public health is the science and art of preventing disease, prolonging life, and promoting health through organized efforts and informed choices of society, organizations, public and private, communities, and individuals.
Q&A
What was the Thalidomide tragedy?
The Thalidomide tragedy was a public health crisis in the early 1960s where thousands of babies were born with severe birth defects due to their mothers taking the drug Thalidomide during pregnancy.
How did Francis Oldham Kelsey prevent Thalidomide from being approved in the United States?
Francis Oldham Kelsey, an FDA reviewer, was skeptical of Thalidomide and refused to approve it despite pressure from the drug company. Her thorough review and insistence on further testing ultimately saved countless lives.
Show Notes
In the 1950s, a German drug company developed a new sedative that was supposed to be 100% safe: thalidomide. So safe, in fact, it was promoted to women as a treatment for morning sickness. It quickly became a bestseller. But in the early 1960s, shocking news started coming out of Europe. Thousands of babies were being born with shortened arms and legs, heart defects, and other serious problems. Many died.
In the United States things were different, thanks to one principled, strong-minded skeptic who joined the Federal Drug Administration in 1960 as a medical reviewer. One of her first assignments was to review the approval application of that very wonder drug, thalidomide. But the application was, to her mind, flawed.
Dr. Frances Oldham Kelsey was a physician, a pharmacologist, and a nitpicker who refused to be intimidated by big pharma.
Starting in September, a new five-part series from Lost Women of Science: The Devil in the Details, the story of Frances Oldham Kelsey, The Doctor Who Said No To Thalidomide.
Table of contents
United States
