The Trials and Tribulations of Tenofovir: Ethics, Political Economy, and Clinical Research in Africa

University Of California-Irvine, Irvine CA

Investigators

Abstract

The clinical trial has long served as the primary medium for which clinical molecules have the potential to be transformed into marketed pharmaceutical products. As such, it is also a symbol of institutional and technological assemblages that mediate between information and global markets. While scholarly attention has been paid to social and cultural issues regarding informed consent and trial ethics, new shifts in the financing and industrialization of clinical trials, combined with new technologies and legal reform, have produced new debates and dilemmas. This project, co-funded by Science and Society, Biology and Society, and the Office of International Science and Engineering, examines these crucial and emergent issues by analyzing a clinical trial that tested the efficacy of a marketed anti-retroviral drug, tenofovir (brand name Viread), as a pre-exposure prophylaxis (HIV prevention technology) in Nigeria, Malawi, Ghana, Cameroon, and Cambodia. Funded by the Gates Foundation and carried out by Family Health International (FHI), four of these five trial sites prematurely shut down for different reasons. The project is conducted in six countries (the U.S., France, Nigeria, Cameroon, Ghana, and Malawi) representing the transnational nature of the trial. Using ethnographic methods and archival research, the research objectives include examining 1) how differing forms of state privatization in both the US and African countries facilitate numerous and more rapid transnational flows of clinical molecules that 2) sets new precedents for the emergence of a science-humanitarian apparatus, which is subsidizing HIV related clinical trials while harnessing new kinds of capital and human mobility in the form of clinical molecules and human trial subjects; and 3) generates emergent debates throughout Africa that reflect radically different sets of ethics not simply at the level of researcher-human subject interactions but also at the level of representation, where scientific rationales, informed consent procedures, and study designs are consistent points of contention. The project will produce conference presentations, journal articles and a book. The broader impacts resulting from the proposed activity include contributing to existing science and technology studies literature focused on multiple forms of therapeutic and pharmaceutical development, distribution, and ethics; on the co-evolution of scientific technologies and privatization/neo-liberal reforms; and on international political economies and drug geopolitics. It will especially impact a small body of research that examines science and technology in post-colonial settings.