Because We Can: Clashes of Perspective Over Researcher Obligation in the Failed PrEP Trials

via Developing World Bioethics, by Bridget G. Haire

Abstract

This article examines the relationship between bioethics and the therapeutic standards in HIV prevention research in the developing world, focusing on the closure of the pre-exposure prophylaxis (PrEP) trials in the early 2000s. I situate the PrEP trials in the historical context of the vertical transmission debates of the 1990s, where there was protracted debate over the use of placebos despite the existence of a proven intervention. I then discuss the dramatic improvement in the clinical management of HIV and the treatment access movement, and consider how these contexts have influenced research practice. I argue that as HIV prevention trials oblige researchers to observe the rate at which vulnerable people under their care acquire HIV, there is an obligation to provide antiretroviral treatment to seroconverters and other health care benefits that fall within the scope of researchers’ entrustment, both to avoid exploitation and to enact reciprocal
justice. I argue against propositions that the obligations to provide specific benefits are vague, fall only upon researchers and sponsors, and create injustices by privileging the few over the many. Finally, I contend that the realisation of a broader standard of care in HIV prevention research broadens the role of research from being a simple tool to produce knowledge to a complex intervention that can play a part in the reduction of health disparities.

Read the full paper here.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Cambodia’s Doomed PREP Trial: What Happened Next?

via Speaking of Medicine, by Gavin Yamey

Remember the doomed PREP (pre-exposure prophylaxis) trial, examining whether tenofovir protects female sex workers (FSWs) from HIV, which was shut down by Cambodia’s Prime Minister in the face of pressure from activist groups? The serious public health implications of the trial’s termination were discussed in a 2004 PLoS Medicine essay:

“Speculation, unwarranted criticism, overreaction, or sensationalizing facts risk stigmatizing tenofovir and could jeopardize future attempts to find an efficacious PREP. This is in nobody’s interest.”

Last week, one of the Principal Investigators of that trial, Kimberly Page, gave a fascinating lecture at the University of California San Francisco, in which she told the audience how she turned the crisis of the trial’s shutdown into an opportunity.

The trial was literally shuttered overnight, said Dr Page, an epidemiologist who studies sexually transmitted infections (STIs). Fortunately, she said, “the NIH,” which funded the trial, “let me keep the money.”

A new research partnership was formed, which included community partners. Out of the ashes of the terminated PREP trial was born a new project, the Young Women’s Health Study (YWHS), which examines HIV risk factors among Cambodia’s FSWs.

Read the rest.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]