The Devil in the Details - Chapter Four
Digest
This podcast tells the story of Francis Oldham Kelsey, a medical reviewer at the FDA, who played a pivotal role in preventing the widespread use of thalidomide in the United States. The podcast begins by introducing Kelsey and her initial skepticism about the drug's safety, which led her to delay its approval. It then explores the aftermath of the Washington Post article that exposed the dangers of thalidomide, highlighting Kelsey's rise to fame as a national hero. The podcast delves into the reasons why Americans were only learning about the dangers of thalidomide in the summer of 1962, despite the drug being withdrawn from the market in Europe months earlier. It reveals the lack of communication and transparency from the American drug company, Meryl, and the FDA's limited knowledge about the drug's distribution. The podcast also introduces Helen Tauzig, a renowned cardiologist who played a crucial role in bringing the thalidomide crisis to the attention of the FDA. It describes her investigation in Europe, her subsequent meeting with Kelsey, and the impact her findings had on Kelsey's understanding of the drug's dangers. The podcast examines the media's coverage of the thalidomide crisis in the United States, highlighting the significance of Morton Mintz's Washington Post article in bringing the story to the forefront of public consciousness and the role of Senator Estes Kefauver in pushing for drug reform. The podcast also explores the overlooked aspect of the thalidomide crisis, focusing on the women who had already taken the drug in the United States and the potential consequences for their pregnancies. It introduces Sherry Chesson, a children's television host who took thalidomide during her pregnancy and faced a difficult decision about her unborn child. The podcast details Sherry Chesson's personal experience with thalidomide, describing her discovery of the drug's dangers, her doctor's advice, and her decision to seek an abortion, which was illegal in Arizona at the time. It highlights the challenges she faced and the impact her story had on public awareness. The podcast concludes by reflecting on the lasting impact of the thalidomide crisis in the United States, emphasizing the importance of Kelsey's actions in preventing a potential tragedy and the role of Sherry Chesson's story in bringing the issue to the forefront of public consciousness. It also raises questions about the timeline of events and the responsibility of the American drug company, Meryl.
Outlines
The Unsung Heroine of Thalidomide
This chapter introduces Francis Oldham Kelsey, a medical reviewer at the FDA, and the story of her role in preventing the approval of the drug thalidomide in the United States. It sets the stage for the podcast by highlighting the significance of Kelsey's actions and the impact they had on public health.
Kelsey's Rise to Fame and the Media's Role
This chapter explores the aftermath of the Washington Post article that exposed the dangers of thalidomide. It details how Kelsey became a national hero overnight, receiving widespread media attention and recognition for her role in preventing a potential tragedy. It also examines the media's coverage of the thalidomide crisis in the United States, highlighting the significance of Morton Mintz's Washington Post article in bringing the story to the forefront of public consciousness and the role of Senator Estes Kefauver in pushing for drug reform.
The Delay in American Awareness and Helen Tauzig's Intervention
This chapter delves into the reasons why Americans were only learning about the dangers of thalidomide in the summer of 1962, despite the drug being withdrawn from the market in Europe months earlier. It reveals the lack of communication and transparency from the American drug company, Meryl, and the FDA's limited knowledge about the drug's distribution. It also introduces Helen Tauzig, a renowned cardiologist who played a crucial role in bringing the thalidomide crisis to the attention of the FDA. It describes her investigation in Europe, her subsequent meeting with Kelsey, and the impact her findings had on Kelsey's understanding of the drug's dangers.
The Unseen Victims and Sherry Chesson's Story
This chapter explores the overlooked aspect of the thalidomide crisis, focusing on the women who had already taken the drug in the United States and the potential consequences for their pregnancies. It introduces Sherry Chesson, a children's television host who took thalidomide during her pregnancy and faced a difficult decision about her unborn child. It details Sherry Chesson's personal experience with thalidomide, describing her discovery of the drug's dangers, her doctor's advice, and her decision to seek an abortion, which was illegal in Arizona at the time. It highlights the challenges she faced and the impact her story had on public awareness.
The Lasting Impact and Lessons Learned
This chapter reflects on the lasting impact of the thalidomide crisis in the United States. It emphasizes the importance of Kelsey's actions in preventing a potential tragedy and the role of Sherry Chesson's story in bringing the issue to the forefront of public consciousness. It also raises questions about the timeline of events and the responsibility of the American drug company, Meryl.
Keywords
Thalidomide
Thalidomide is a drug that was marketed as a sedative and antiemetic in the 1950s and 1960s. It was later discovered to cause severe birth defects, including phocomelia (abnormally short limbs), in children whose mothers had taken the drug during pregnancy.
Phocomelia
Phocomelia is a rare birth defect characterized by the absence or malformation of limbs, often resulting in hands or feet being attached directly to the torso. It is a severe condition that can significantly impact a child's physical development and quality of life.
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, food supply, cosmetics, and radiation-emitting products.
Drug Reform
Drug reform refers to changes in laws and regulations related to the production, distribution, and use of drugs. It often involves efforts to address issues such as drug abuse, addiction, and the availability of safe and effective medications.
Public Awareness
Public awareness refers to the level of knowledge and understanding that the general public has about a particular issue or topic. It is crucial for promoting informed decision-making and influencing public policy.
Medical Ethics
Medical ethics is a branch of ethics that deals with moral principles and values that guide medical practice. It encompasses issues such as patient autonomy, confidentiality, informed consent, and the allocation of scarce resources.
Birth Defects
Birth defects are abnormalities present at birth that can affect a child's physical or mental development. They can range from minor to severe and can be caused by genetic factors, environmental exposures, or unknown causes.
Pregnancy
Pregnancy is the period of time during which a woman carries a developing fetus in her womb. It typically lasts about 40 weeks and is a significant physiological and emotional experience for both the mother and the developing child.
Q&A
What was the role of Francis Oldham Kelsey in the thalidomide crisis?
Francis Oldham Kelsey was a medical reviewer at the FDA who refused to approve thalidomide for sale in the United States. Her decision, based on her skepticism about the drug's safety, prevented a potential tragedy that could have resulted in thousands of American babies being born with severe birth defects.
Why did it take so long for Americans to learn about the dangers of thalidomide?
The American drug company, Meryl, failed to fully inform the FDA about the drug's withdrawal from the market in Europe and its potential dangers. Additionally, the FDA had limited knowledge about the drug's distribution in the United States, leading to a delay in public awareness.
How did Helen Tauzig contribute to the thalidomide story?
Helen Tauzig, a renowned cardiologist, investigated the thalidomide crisis in Europe and brought her findings to the attention of the FDA. Her firsthand account of the tragedy and the evidence she presented convinced Kelsey of the drug's dangers and prompted her to take further action.
What was the impact of Morton Mintz's Washington Post article on the thalidomide crisis?
Morton Mintz's article, which exposed the dangers of thalidomide and highlighted Kelsey's role in preventing its approval, brought the story to the forefront of public consciousness. It sparked widespread outrage and led to increased pressure on the government to implement stricter drug regulations.
How did Sherry Chesson's story contribute to the thalidomide narrative?
Sherry Chesson, a children's television host, took thalidomide during her pregnancy and faced a difficult decision about her unborn child. Her story, which was widely publicized, underscored the personal impact of the thalidomide crisis and made the issue feel more real and relatable to Americans.
Show Notes
It’s the summer of 1962 and thalidomide has been off the market in Europe for months. But in the U.S., people are only just beginning to find out about the scandal. The Washington Post breaks the story and puts a picture of Frances Kelsey on the front page. She’s the hero who saved American lives. President John F. Kennedy gives her a medal and her image is splashed across newspapers around the country. At the end of the previous year, Merrell, the company that wanted to sell thalidomide in the U.S., had made a half-hearted attempt to contact some of the doctors who had been given millions of thalidomide samples for so-called clinical trials. Just how many pregnant women might have thalidomide in their medicine cabinets?