The Child as Scientific Problem—and Business Opportunity: Paediatric Drug Policy in the United States, 1933-1979
The issues embedded in discussions of children and drug safety and efficacy involve considerations regarding society’s obligations to children, evolving understandings of their place and protection in society, determinations of who should decide what interventions are in their best interests, and how they should be funded. This seminar will discuss the challenges and legacy of these historical contexts and their effect upon today’s healthcare systems.
Background: In 1972, American paediatrician Harry Shirkey’s frustration boiled over. The nation’s leading advocate for stronger pediatric drug regulation felt stymied in his long term goal of assuring that drugs used in children were safe and effective. He argued that it was long past the time when it was considered acceptable for children to languish as “therapeutic orphans,” denied their “pharmacological rights” through label disclaimers acknowledging the lack of paediatric safety and efficacy data. Despite major pieces of drug legislation in 1938 and 1962 and decades of negotiations between professional organizations, the Food and Drug Administration, Congress, industry, health care providers and parents in the years between 1933 and the 1970s, the problem of the child as ‘therapeutic orphan’ in terms of drug safety and efficacy knowledge was widely acknowledged by 1979.
About the presenter: Cynthia Connolly, PhD RN FAAN at The University of Pennsylvania
Cynthia Connolly PhD RN FAAN is a paediatric nurse, historian of children’s health care, and associate professor at the University of Pennsylvania School of Nursing, where she is the Rosemarie B. Greco Term Endowed Associate Professor in Advocacy. She is also Associate Director at the Barbara Bates Center for the Study of the History of Nursing, a Faculty Director at the Field Center for Children’s Policy, Practice, and Research, and a Senior Fellow at the Leonard Davis Institute of Health Economics, both at the University of Pennsylvania. Cynthia is the author of Saving Sickly Children: The Tuberculosis Preventorium in American Life, 1909–1970 (Rutgers University Press, 2008) and Children and Drug Safety: Balancing Risk and Protection in Twentieth Century America (Rutgers University Press, 2018).
This seminar is co-presented by The University of Manchester's Health Services Research Centre (HSRC), Centre for the History of Science, Technology of Medicine (CHSTM) and the UK Association for the History of Nursing (UKAHN). Stephanie Snow, Senior Research Fellow at the Division of Medical Education, will preside as Chair.
A light luncheon will be served at 12:00, with the seminar commencing at 12:15.