Kelsey's Role after the Thalidomide Case
After the thalidomide incident, Kelsey became the head of the FDA's Investigational Drug Branch (now the Division of Scientific Investigations) where she made further progress in clinical trial regulation, including establishing the three phases of clinical research that are used as the gold standard worldwide. She enforced FDA regulation, created new regulations in the 1970s, and conducted oversight visits to study sites to ensure high quality study data. The former commissioner of health affairs at the FDA, Stuart Nightingale, MD, noted that Kelsey played a key role in what is now considered "good clinical practices" globally. She remained active in her efforts to push for good clinical practice throughout her work in the 1990s and continued to serve as an in house expert on teratology and advisor to FDA staff working on such issues throughout her career.24
The Lasting Impact of Thalidomide Exposure
Labeled as "Thalidomide babies," the children are now in their 50s and have lived the majority of their lives with such deformities. Two victims in the U.S. share their stories in the Huffington Post where they reflect, "we were deemed dysfunctional, broken, damaged from the start." They share their experiences attending school, driving without 'adaptors, engaging in hobbies, battling with the decision to use prosthetics, and continually working to uncover the truths of the thalidomide story.
Reflection Questions
- How has the FDA changed since the thalidomide case?
- How did the impact of thalidomide come to the public's attention?
- What kind of studies/reports revealed the drugs impacts?
- What were the leadership qualities that Kelsey demonstrated in this case?
- What kinds of pressures did Kelsey and her colleagues face when reviewing the thalidomide application?
- What do you think enabled her to withstand them?