Frances Odham Kelsey is best known for her role in blocking Food and Drug Administration (FDA) approval of thalidomide in the United States. Thalidomide, an anti-emetic and anti-anxiety drug, was widely distributed in Europe and heavily pushed in the United States by the drug’s manufacturer. As an FDA reviewer, Kelsey was tasked with evaluating the drug’s safety. Despite pressure from both the drug company and her superiors, Kelsey held firm to her scientific skepticism and refused to approve the drug unless the company could produce sufficient evidence of safety. In particular, she cited concerns about peripheral neuropathy and the absence of testing on pregnant animals. When the story broke that thalidomide caused a devastating wave of birth defects abroad, the press called her a heroine who saved thousands of American babies from suffering the same fate as those children in Europe and Japan. The story of thalidomide is widely available in many sources and proudly displayed on the FDA website. What makes this book different and interesting is the deep dive it takes into Kelsey’s early life and particularly her career after thalidomide.

The first chapters explore Kelsey’s childhood in Canada and her education. This includes memoirs and stories that are loosely strung together to present a picture of a young women curious about the natural world. Kelsey’s challenging educational journey and early career are a reflection of the social norms of the time. She earned a PhD in pharmacology and later an MD at a time when few women were admitted to graduate programmes in science or medicine. Kelsey was a hard-working dedicated scientist, but her skills were underappreciated at the time. In the 1950s and 1960s, jobs were seldom given to women and this book explores the unwelcoming environment for women in science at the time. A college course that includes second-wave feminism and workplace equality may find these chapter readings useful.

The book then examines Kelsey’s role in blocking thalidomide, which is often regarded as a major turning point in drug regulation. The thalidomide disaster led to significant changes in the way the FDA oversees the safety and efficacy of pharmaceuticals, inspiring stronger laws regarding drug testing and the approval process. Kelsey’s contributions led to sweeping changes in drug safety regulations, particularly the Kefauver-Harris Amendment of 1962, which introduced stricter controls on drug testing and approval.

Perhaps the most interesting part of the book is Kelsey’s career at the FDA after thalidomide. Her fame made her a high-profile figure, and she was brought in as a consultant on many aspects of drug approval. She became a leading figure in advocating for the protection of patients enrolled in clinical studies, ensuring that informed consent and safety protocols were clarified and that vulnerable populations were protected. The book discusses several examples in depth: prison populations, pregnant women and children. In the case of prison populations, volunteers were offered time in a more desirable clinical setting with better food and amenities. This could be seen as a type of coercion. In the case of pregnant women, mothers who sought prenatal care were sometimes not informed about the experimental status of the drugs they were given. The detrimental effect of an experimental drug could take years to manifest. For example, diethylstilbestrol (DES), which was experimentally administered to prevent miscarriage, caused certain types of cancer in girls born to these mothers. In the case of children, the question remained how can a child ever give consent, and any financial reward to the parents is a type of coercion.

Shockingly, many clinical trials lacked proper oversight and data were not collected in a useful manner. In the end, many people were needlessly injured for no scientific gain. Kelsey’s work was not just about advancing well-designed scientific protocols, but also about ensuring that scientific progress was guided by ethical responsibility and a deep commitment to public health. While students in medicine and pharmacology learn about the process of FDA approval, almost nothing is taught about clinical trials and how ‘volunteers’ are selected. It is worth covering these chapters in any classes that explore drug development. Clinical trials are about looking for side effects initially and efficacy later, but some side effects take years to manifest. These are important class discussions: who are the people who volunteer and what is the obligation researchers have to the long-term health and safety of volunteers? Overall, the book offers readers a powerful reflection on the intersection of science, ethics and public health.