Frances Oldham Kelsey, the FDA, and the Battle against Thalidomide

The woman scientist who saved Americans from thalidomide In the early 1960s, Dr. Frances Oldham Kelsey of the U.S. Food and Drug Administration became one of the most celebrated women in America when she prevented a deadly sedative from entering the U.S. market. A Canadian-born pharmacologist and physician, Kelsey saved countless Americans from the devastating side effects of thalidomide, a drug routinely given to pregnant women to prevent morning sickness. As the FDA medical officer charged with reviewing Merrell Pharmaceutical's application for approval in 1960-61, Kelsey was unconvinced that there was sufficient evidence of the drug's efficacy and safety. Despite substantial pressure, she held her ground for nineteen months while the extent of the drug's worldwide damage became known-thousands of stillborn babies, as well as at least 10,000 children across 46 countries born with severe deformities such as missing limbs, arms and legs that resembled flippers, and improperly developed eyes, ears, and other organs. As a result of Kelsey's efforts, thalidomide was never sold in the United States. The incident led Congress to pass the 1962 Drug Amendment, which fundamentally changed drug regulation in America. Those regulations, still in force today, required pharmaceutical companies to conduct phased clinical trials, obtain informed consent from participants in drug testing, and warn the FDA of adverse effects, and it granted the FDA important controls over prescription-drug advertising. One of a small minority of women to earn an advanced degree in science in the 1930s, Kelsey faced challenges that resonate with women scientists to this day. Revered by the public as a “good mother of science,” she went on to act as a formidable gatekeeper against other suspect drugs, such as diesthylstilbestrol (DES) and laetrile. As part of the team that tested anti-malarial drugs on prisoner volunteers during World War II, she later was instrumental in the formulation of ethical protocols for drug testing on prisoners and the vulnerable, including the elderly and children. Yet behind the public adulation, she faced professional jealousies and glass ceilings, political interference with FDA's actions, and ongoing hostility from pharmaceutical industry officials. She was sustained and supported by family and friends, co-workers and mentors, and a lifetime commitment to good science. Based upon FDA archival records, private family papers, and interviews with family and colleagues, this biography brings to light the efforts and legacy of a pioneering woman of science whose contributions are still influential today.

Cheryl Krasnick Warsh is Professor of History at Vancouver Island University in Nanaimo, Canada. Dr. Warsh has published books on the history of asylums, women's health, children's health, consumerism, and alcohol and drug use. She served as long-term editor-in-chief of the Canadian Bulletin of Medical History and was co-editor of Gender & History. Dr. Warsh was a Fulbright Fellow, AMS/Hannah Fellow, and the inaugural recipient of the Vancouver Island University Distinguished Researcher Award. In 2017, she was elected a Fellow of the Royal Society of Canada for her contributions to Canadian medical history.

Introduction Chapter 1: Balgonie to Balgonie Chapter 2: University in Canada Chapter 3: Doctoral Studies at the University of Chicago Chapter 4: Whales, Cod, Armadillos and Glass Ceilings: The Postdoctoral Years Chapter 5: Wartime in Chicago Chapter 6: Marriage, Motherhood, and Medical School Chapter 7: Adventures in South Dakota Chapter 8: The Early Washington Years Chapter 9: The Thalidomide File Chapter 10: The Battle of the Lady and the Dragon Chapter 11: Thalidomide Babies Chapter 12: The Good Mother of Science: Letters to Frances Kelsey Chapter 13: The Canadian Connection Chapter 14: The Living Myth, 1963-1966 Chapter 15: Negotiating Washington, 1966-1982 Chapter 16: Peaches, Oyster Breath, and Diet Cola: Public Demands for Product Approvals Chapter 17: The Ticking Time Bomb: Diesthylstilbestrol Chapter 18: Policing Informed Consent, 1960s-1990s Chapter 19: Babies and Orphans: Drug Testing in Utero and in Children Chapter 20: Lasting Memorials, Everyday Happenings Epilogue Notes Selected Bibliography