This 12-minute video chronicles how thalidomide, once prescribed to pregnant women to combat morning sickness, was tied to a wave of devastating birth defects, leading the federal government to enact a process for drug approval. The video documents how President John F. Kennedy used the crisis created by thalidomide to dramatically expand regulatory control over the pharmaceutical industry; it can be used to initiate a discussion about how public policy is made. By highlighting the efforts of one young female scientist at the Food and Drug Administration, who sounded the alarm on thalidomide’s dangers and became a national hero, the video also shows how professionalism within the civil service can have a profound impact on the wellbeing of everyday Americans. This story can be used by science teachers to illustrate the research and discovery process by documenting the journey of thalidomide from pharmaceutical to banned substance to its reemergence today as a treatment for various cancers.
Thalidomide: Return of an Infamous Pill
How a pill that led to drug safety guidelines became a case study for rising drug prices.
Strict prescription drug safety regulations in place today resulted in part from the devastating consequences of a pill prescribed during pregnancy that was originally thought to be harmless. Strict F.D.A. safety guidelines were developed after thalidomide left a trail of severe birth defects. Today, it has become a case study for rising drug prices.
View full episodes at PBS.org/RetroReport.
Modern regulation of pharmaceuticals can be traced to the 1950s and public uproar over a pill called thalidomide.
The drug was developed by a German company, Chemie Grunenthal, and initially marketed as Kevadon across Europe and England in the 1950s as a safe, effective sleeping pill that could also be used to treat morning sickness. Thalidomide was so widely prescribed in some European countries that it became almost as common as aspirin. By 1960, Grunenthal was seeking permission from the F.D.A. to sell the drug in the U.S.
The license review for thalidomide fell to Dr. Frances Oldham Kelsey, a family doctor from South Dakota who had recently taken a job with the F.D.A. She became concerned that there was scant scientific evidence supporting the drug’s use. At that time, F.D.A approval of a new drug was considered routine, but Dr. Kelsey pressed for more data from the William S. Merrell Company of Cincinnati, which was seeking the U.S. license. Merrell resisted her requests.
In 1961, terrible evidence began pouring in from Europe linking use of the drug to thousands of cases of children born with congenital abnormalities. Merrell withdrew its application.
Dr. Kelsey’s professional vigilance had blocked similar outcomes in the United States, but the thalidomide debacle ignited public alarm about drug safety. President Kennedy reinforced the need for tighter regulation, and in 1962, Congress passed groundbreaking legislation that required drug makers to test new products extensively and prove they were safe and effective before bringing them to market. Today’s F.D.A. guidelines stem from those that were implemented because of thalidomide.
Students will learn how a prescription medication’s devastating side effects shocked the nation decades ago and led to today’s federal drug safety guidelines.
- Why thalidomide was banned by the F.D.A. in 1962 and what that has meant for every drug that has come to the U.S. market since.
- How the story of thalidomide illustrates the effects of competing influences on the creation of public policy.
- How the scientific drug discovery process works.
- What was thalidomide prescribed for? Why did pregnant woman take it?
- Why did Dr. Francis Kelsey at the F.D.A. hold up approval of thalidomide? What were her concerns? Why is she regarded as a hero?
- When the families of children born with congenital abnormalities asked for help to cover the cost of caring for their children, what was the initial response of Grunenthal, thalidomide’s manufacturer? What did victims of the drug have to do to receive financial compensation? When did Grunenthal apologize?
- Why has thalidomide returned in recent years? What is it being used to treat? Why are babies still being born with birth defects from thalidomide?
- How is the thalidomide tragedy affecting policy and regulation today?
- Common Core State Standards
- CCSS.ELA.LITERACY.RH.11-12.7:Integrate and evaluate multiple sources of information presented in diverse formats and media (e.g., visually, quantitatively, as well as in words) in order to address a question or solve a problem.
- CCSS.ELA.LITERACY.RI.11-12.3:Analyze a complex set of ideas or sequences of events and explain how specific individuals, ideas, or events interact or develop over the course of a text.
- National Council for the Social Studies C3 Framework
- D2.Geo.12.9-12. Evaluate the consequences of human-made and natural catastrophes on global trade, politics, and human migration.
- AP Psychology
- Unit 2: Biological Bases of Behavior
- Unit 1: Scientific Foundations
- AP Government and Politics
- Topic 5.6: Interest Groups Influencing Policy MakingSkill 1.D: Describe policies illustrated in different scenarios in context.