Paper short abstract:

Injustice in healthcare has life or death consequences. Anthropologists can respond through new FDA policy encouraging patient voices in drug development. Systematic qualitative methodologies can explore heterogeneity underlying unmet healthcare needs with psychological anthropology.

Paper long abstract:

Injustice in healthcare has life or death consequences, extending well beyond clinical settings to social, cultural, and economic contexts. The focus of this paper is the FDA effort to develop Patient-Focused Drug Development (PFDD) guidance in accordance with the 21st Century Cures Act to support systematic approaches to collecting and integrating patient insight into medical product development and regulatory decision making. This initiative is an opportunity for anthropologists to bring qualitative voices directly to healthcare.

Systematic methodologies for collecting qualitative evidence are needed, and even if not always detailed in publications, a wealth of approaches characterize the fields of anthropology. In this paper, I primarily focus on the role of person-centered interviewing in drug development, where heterogeneity can too often be viewed as a lack of results rather than a goal in and of itself. Acknowledging heterogeneity is central to addressing injustice in drug development, as it can address the unmet needs of patient populations facing geographic dispersion, economic insecurity, health fragility, and discriminatory dismissals.

Psychological anthropology can illustrate patient perspectives with theoretical fluidity and individualized, holistic approaches. Cultural practices supporting transmission, subjectivity within structures of power, psychodynamic motivations underlying the internalization of schemas, and resonances of the social politic help represent patients’ perspectives. Qualitative data can be utilized with mixed methods approaches to further interpretations and, in turn, quantitative data can be validated through narratives detailing meaningful and noticeable change in symptoms. Through these efforts, anthropologists can use our position to elevate the voices of vulnerable populations.