Rethinking the Bioethical Enactment of Medically Drugged Bodies: Paradoxes of Using Anti-HIV Drug Therapy as a Technology for Prevention

Abstract

In this paper we examine the work of bioethics in the enactment of medically drugged bodies by focusing on the development of an oral pre-exposure chemo (drug) prophylaxis for preventing HIV, called PrEP. Our aim is to show how the operationalisation of bioethics to mediate drug development obscures a more complex and relational dynamic out of which emerges the qualities and, indeed, problematics of bodies incorporated into PrEP. Our analysis is drawn from a small body of literature from trial affected communities, advocacy groups, researchers and trial sponsors. In particular, we focus on bioethical questions about how best to protect the interests of participants in ‘offshore’ randomised clinical trials. We argue that the predominant bioethical frame insufficiently addresses the challenges posed by PrEP. By rendering PrEP a singular thing that differs across contexts, more fruitful alternative conceptions are obscured. Specifically, we argue that PrEP trials should be conceived as ‘ontologically multiple’—emerging out of divergent assemblages of heterogeneous entities, including material and cultural differences in and across context-specific bodies. On the basis of this alternative account of PrEP, we propose that the bioethical work of pharmaceutical development can become more inclusive.

Keywords:

• HIV
• bioethics
• drugs
• pre-exposure prophylaxis (PrEP)
• clinical trials
• multiple ontologies

Acknowledgements

The authors would like to thank Mitchell Warren, AIDS Vaccine Advocacy Alliance (AVAC) and Dean Murphy, previously at the Australian Federation of AIDS Organisations (AFAO) for their assistance with access to the PrEP field as well as the two anonymous referees and the journal editors for their comments on the piece. They would also like to acknowledge support from the Goldsmiths Research and Knowledge Transfer Committee, the Foundation for the Sociology of Health and Illness, and Gilead Sciences Inc. for providing an image of PrEP.

Notes

We prefer the term ‘drugged bodies’ to the more obvious ‘patients’ or ‘communities’ for three reasons. Firstly, it better connotes the materiality entailed in the PrEP case study. Secondly, the ‘objectness’ of ‘drugged bodies’ also evokes their calculability by typical bioethical methods of cost/benefit analysis. Thirdly, and relatedly, the notion of static ‘drugged bodies’ mutually implies a static ‘bioethics’, which neatly contrasts with the more complex, dynamic, emergent version of bioethics that we attempt to articulate in the paper.

The randomised clinical trial is regarded as a fully scientific objective form of evaluating drugs, noted to have replaced more social and cultural models of healing, a subjectively deduced effect. It involves comparing two groups, one subject to the intervention while the other is not but using a method where those directly involved—the researchers and the trial participants—do not know who is receiving the drug and who is receiving a placebo.

The drugs used for PrEP are Tenofovir (Viread®) (TDF) or Tenofovir and Emtricitibine (Emtriva®) (FTC) combined and called Truvada. They are part of the HIV antiretroviral class of drugs called nucleotide reverse transcriptase inhibitors. Both are manufactured by Gilead Sciences Inc.

We add the qualification ‘legitimate’ because we have come across a number of anecdotal accounts that suggest that because of the availability of the drugs PrEP is already being prescribed although unauthorised.

Prior to PrEP, there has been limited availability of post-exposure prophylaxis (PEP) in the United Kingdom, Australia, Canada and the United States. PEP consists of a one month course of antiretroviral therapy. There is continuing debate on PEP, some of which is very similar to the debate on PrEP (see Richens et al., 2005; Ghosn et al., 2002).

While PrEP is a form of microbicide referred to as ‘systemic’, a topical microbicide is a gel or cream applied to a specific area of the body where exposure takes place, for example, the vagina or anus.

Adverse events are conditions reported by trial participants and recorded within the trial as possibility associated with the intervention under trial.

Intercurrent infection is a feature of HIV prevention trials as will be discussed later. Although the infection is not acquired from the agent under trial, the phenomenon may be deemed an effect of alterations in risk understandings or in physiology due to the product under trial. While physiological alterations have been entirely unexpected contributors to intercurrent infection, of late this possibility has been raised by the Merck STEP trial (see Robertson et al., 2008).

The Cambodian trial was to be carried out by the National Center for HIV/AIDS, Dermatology and STDs (NCHADS) of the Ministry of Health in Cambodia with the University of California, San Francisco, USA and the University of New South Wales, Australia.

It is worth noting that reports by Chaya (2006) and UNAIDS (2007) point to a decline in HIV prevalence rates since this time and this is attributed to the promotion of condoms.

It is beyond the scope of this paper to detail the reasons for the Cambodian government decision. However, anecdotal reports suggest that the decision to stop the trial may have been to do with the complex political arrangements involved in the governance of Cambodia as well as the confusion surrounding the running of the trial.

The findings of this trial are too small to offer conclusive evidence on PrEP. However they do provide support for further trials.

Of course, while community protest has been noted as immensely significant in bringing about change in the scientific world and notably through HIV/AIDS activism prior to antiretrovirals (see Epstein, 1996), such action has more usually been focused on mobilising more research or modifying regulations.

In the course of a qualitative study conducted with PrEP stakeholders during 2007–2008 we found that the possibilities of implementing PrEP in resource poor contexts are likely to be directly affected by the way in which PrEP works. The statistical assessment of its efficacy will determine whether it requires close clinical monitoring, unavailable in some locales of HIV vulnerability.

For readers unfamiliar with the history of HIV clinical trials, initially those involved in the development of antiretroviral drugs were conducted with populations of gay men in the United States and other industrialised settings with epidemics recognised in gay men such as the United Kingdom, Canada and Australia. At present, PrEP safety (not efficacy) trials are being conducted in the United States with gay men.