Kevadon (or better known by its generic name, Thalidomide) was a widely used drug in the 1950s to support sleep and to treat nausea in pregnant women.1 The Grünenthal Group in Germany created Thalidomide in 1953 and the first paper on its pharmacological effects was published in 1956.2 Reports noted its superiority to comparator drugs and its nontoxic elements.3 Thalidomide was licensed for use in the UK in 1958 and reached the Food and Drug Administration for marketing approval in September 1960.4 The drug application to the FDA, however, never passed, as reviewers required more data to prove its safety. In 1961, reports began to emerge in Germany and the United Kingdom that women taking thalidomide during pregnancy gave birth to children with severe birth defects.5 In 1961, the Australian doctor, William McBride wrote to the Lancet Medical Journal regarding an observed increase in the number of deformed babies born at his hospital, all of which took thalidomide during pregnancy.6 By late 1961, several case reports and further evidence surfaced across Europe, Britain, Canada, and the Middle East linking Thalidomide to children born with flipperlike arms and legs and other defects including deformities of ears, eyes, and cardiac and gastrointestinal irregularities.7
After successfully completing this module, the student will be able to:
- Discuss the leadership role of Dr. Frances Oldham Kelsey in the midst of a then largely routine medical application and austere pressure from drug companies.
- Explain how Dr. Frances Oldham Kelsey pushed gender pressures and stereotypes during a period when women fought for their voices in the professional field.
- Describe the regulations that ensued after the thalidomide tragedies