Saying ‘No’ to PrEP research in Malawi: what constitutes ‘failure’ in offshored HIV prevention research?

Abstract

Between 2004 and 2005, the first multi-sited clinical trial tested whether an existing, marketed antiretroviral drug, Tenofovir (TDF), could prevent HIV transmission. Referred to as pre-exposure prophylaxis (PrEP), most of these trial sites prematurely closed down. Two sites located in Cambodia and Cameroon received international media attention. But little attention was drawn to sites in Malawi and Nigeria, where university ethicists and research scientists extensively debated PrEP. This article focuses on events that took place in Malawi where there was a prolonged dispute over the scientific rationales of PrEP and not trial specific ethics referred to as 'bioethics'. Specifically, the article discusses debates pertaining to three PrEP trial protocols that were refused ethics approval in Malawi between 2004 and 2009. It is argued that HIV science debates in Malawi are embedded in postcolonial politics--geopolitical histories and state and household economic dispossessions that have created the structural possibilities for Malawi to become an offshore destination for HIV clinical research. As such, ethics in this case does not pertain to trial or bioethical 'failures'. Rather, ethics is located at the scale of imperial relations that give rise to multiple, often invisible, research concerns and constraints.

Ethical Gifts?: An Analysis of Soap‐for‐data Transactions in Malawian Survey Research Worlds

“…Peterson et al. () show how research institutions in Malawi likewise take a diachronic approach to ethics. They document how proposals for HIV pre‐exposure prophylaxis (PrEP) clinical trials were deemed unethical by Malawian ethical review boards not because of worries over trial practices, but because the protocol did not explicitly deal with questions about future research agendas, future drug access, and so on.…”

HIV prevention clinical trials’ community engagement guidelines: inequality, and ethical conflicts

“…As the trials were underway, these concerns went unaddressed, which led to local and international protests by HIV advocates and premature closure of the trials in Cambodia and Cameroon (Cooper, 2013 ; Forbes & Sanushka, 2009 ; IAS, 2005 ; Michael & Rosengarten, 2013 ; Sandy, 2012 ; Peterson et al, 2015 ; Ukpong & Peterson, 2009 ). The reason given by the trial sponsor (Family Health International) for the shutdown of the study in Nigeria was related to concerns about the local research site’s poor adherence to good clinical practice.…”

Community Inclusion in PrEP Demonstration Projects: Lessons for Scaling Up

“…Organized community action led to a halt of the trials in Cambodia and Cameroon due to concerns about the standard of prevention and care 12 . Trials failed to start in Malawi because of ethical concerns about access to care for study participants who HIV seroconverted and developed resistance to HIV treatment due to their PrEP use 15 . Although significant concerns were raised about the Thai trial, it ultimately proceeded 16 , while the trial in Nigeria was discontinued by the research team based on non-protocol adherence 17 .…”