Author Archives: Samantha Gottlieb

Samantha Gottlieb is a medical anthropologist whose work focuses on health technologies and patient activisms. She has taught at California State University, East Bay, and was a Visiting Scholar at UC Berkeley's Center for Science, Technology, Medicine and Society. Her first book, Not Quite a Cancer Vaccine, explored how the marketing and promotion of the human papillomavirus (HPV) vaccine in the U.S. elicited vaccine anxieties in parents and fostered distrust in the general public. Her current project has followed the open source community among people living with type 1 diabetes. It is funded by the National Science Foundation and examines the transition in the U.S. regulatory and commercial conceptions of the engaged patient.

The FDA, Patient Empowerment, and the Type 1 Diabetes Communities in the Era of Digital Health

The day-long September 2018 workshop, “Medical Devices-Patient Engagement in Real World Evidence: Lessons Learned and Best Practices,” sponsored by the Food and Drug Administration (FDA) and University of Maryland (UM), met on the Baltimore campus, the city where I spent my graduate school years. In contrast to Baltimore’s palpable desperation, UMB’s health campus gleamed with newness, its brick walkways and tastefully planted vegetation viewable through floor-to-ceiling windows. In the well-appointed auditorium, Dr. Jeffrey Shuren, director of the Center for Devices and Radiological Health (CDRH, pronounced ‘cedar’), closed his introduction to the conference with the pronouncement that as the FDA moved toward real world evidence (RWE), “patient engagement” and the data patients may collect are invaluable for RWE. (read more...)