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

替诺福韦的考验和磨难：伦理学、政治经济学和非洲的临床研究

• 批准号: 0724794
• 负责人: Kristin Peterson
• 金额: $ 41.17万
• 依托单位: Michigan State University
• 依托单位国家: 美国
• 项目类别: Continuing Grant
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-15 至 2008-05-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=0724794&HistoricalAwards=false
• 关键词: Trials; Tribulations; Tenofovir; Ethics; Political

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.

临床试验长期以来一直是临床分子有可能转化为上市药品的主要媒介。因此，它也是在信息和全球市场之间起中介作用的机构和技术集合体的象征。虽然学术界一直关注有关知情同意和试验伦理的社会和文化问题，但临床试验融资和产业化的新变化，加上新技术和法律的改革，产生了新的辩论和困境。该项目由科学与社会、生物与社会以及国际科学与工程办公室共同资助，通过分析一项临床试验来研究这些关键和紧急的问题，该试验测试了一种上市的抗逆转录病毒药物替诺福韦（商标名Viread）作为暴露前预防（艾滋病毒预防技术）在尼日利亚、马拉维、加纳、喀麦隆和柬埔寨的疗效。由盖茨基金会资助并由国际家庭健康组织（FHI）进行的这五个试验中心中有四个因不同原因提前关闭。该项目在六个国家进行（美国，法国、尼日利亚、喀麦隆、加纳和马拉维）代表了试验的跨国性质。使用人种学方法和档案研究，研究目标包括：1）美国和非洲国家不同形式的国家私有化如何促进临床分子的大量和更快速的跨国流动，2）为科学人道主义机构的出现树立了新的先例，资助艾滋病相关的临床试验，同时利用新型资本和以临床分子和人体试验对象形式的人员流动; 3）在整个非洲引发了紧急辩论，这些辩论不仅反映了研究人员与人类受试者互动的层面，而且反映了代表性层面的根本不同的伦理学，其中科学原理，知情同意程序和研究设计是一致的争论点。该项目将制作会议报告、期刊文章和一本书。拟议活动产生的更广泛影响包括为现有的科学和技术研究文献作出贡献，这些文献侧重于多种形式的治疗和药物开发、销售和伦理;科学技术的共同发展和私有化/新自由主义改革;以及国际政治经济和毒品地缘政治。它将特别影响一小部分研究，这些研究审查后殖民环境中的科学和技术。