Blue Tablets Spilled

AAA Meeting 2013: Chicago

Panel: Danger!

The Dangers of Developing HIV Vaccines: Risk, Affect and the ‘end of AIDS’.

Ryan Whitacre (UC San Francisco / UC Berkeley)

Dr. G is an HIV physician and clinical researcher. She works for a private research group that is funded by the National Institutes of Health and housed within the San Francisco Department of Public Health. She conducts research concerning HIV vaccines and HIV pre-exposure prophylaxis, or “PrEP”. This field of research — one that assesses the intersections of new HIV science — is a field of ‘danger!’

HIV PrEP is a relatively new intervention. It functions with the logic that HIV-negative people can take an antiretroviral drug to prevent HIV. It requires regular — currently, daily — adherence. PrEP has been compared to contraceptive pills to prevent pregnancy, though I am uncomfortable with this comparison because the stakes of each are rather different. In any case, HIV vaccines offer something different. Their logic and use is more well known — commonly conceived as both, a one-time inoculation and a universally-applicable solution for prevention. However, vaccines for HIV cannot promise what vaccines are generally known to. In fact, in research for vaccine development a serious realization must be confronted — that is, one must acknowledge that no universalizable vaccine can be developed to prevent HIV. HIV, as a virus, has too many strains — it has mutated in too many ways, in too many bodies — to be addressed universally. So vaccines can’t promise enough and PrEP offers something new. These recognitions reanimate decades-old debates over what should be prioritized in HIV prevention, and how prevention relates to treatment.

Dr. G is working on a project that brings these considerations together in new ways. In this research she seeks to identify the appropriate “standard of prevention” to be used in clinical trials for HIV vaccines. I have been conducting research about HIV treatment and prevention for three years and was not aware that determining the standard of prevention in such trials was an open question. The FDA approved an antiretroviral drug (sold under the brand name “Truvada”) for PrEP in 2012, and Truvada-based PrEP is the only biomedical modality for HIV prevention approved by the FDA available today. So I assumed Truvada-based PrEP would need to be the standard of prevention in any further prevention trials. But apparently this is not the case. Dr. G’s study — and potentially, also, mine — will learn from researchers and policy makers involved in clinical trials for PrEP and HIV vaccines, assess the relationship between the two, and work toward an answer to the question: what is an adequate amount of prevention to be offered in the context of a trial?

This question is related to asking, “Does PrEP need to be used?” But the question remains open to solicit alternative possibilities. In my conversation with Dr. G I learn these possibilities are mediated by a litany of ethical issues related to the design of trials. These concerns begin with another decades-old concern — access to ‘life-saving’ drugs. She tells me, “Access differs dramatically in different parts of the [United States]. For example, in San Francisco, we have the [PrEP demonstration] project.” This project is offering Truvada to men who have sex with men (MSM) and transgender women to assess the degree to which PrEP can be effective outside of clinical trials. To be clear, in San Francisco, Truvada is being offered to ‘healthy’ people for prevention. “But in Atlanta, people who are HIV-infected are on waiting lists for [the AIDS Drug Assistance Program]. People who are infected can’t even access treatment.” “So,” she asks, “is it ethical within the context of a clinical trial to provide Truvada?”

She then continues, “Another issue is that including Truvada in a clinical trial doubles the cost.” I clarify, and learn the costs would not increase because of an increase in the amount of drug offered. Gilead Sciences, the producer of Truvada, would provide all of the drug needed for the trial, as it has with every other trial for PrEP. Rather, the cost would increase with the counseling and other health services made available to participants. Including Truvada would necessitate this doubling of participants “in order to observe an increase in the rate of HIV acquisition.” In a sense, a trial that includes Truvada as the standard of prevention would need to observe a larger number of people sero-convert.

After giving these ethical quandaries a moment, she adds that it is also an issue to include Truvada as the ‘standard for prevention’ because “we may not even get an answer.” There would be a cascade of necessary measurements, each contingent on all others, that would present potentially confounding conditions under which the possibility of establishing efficacy may be completely erased. In her words:

Were people taking Truvada? Were they not? … We may spend so much time trying to tease out how PrEP affected the vaccine efficacy that we may not even get an answer. So, we have to really think hard about how to design future trials … And it’s an ethical debate. We need to make these decisions with communities.

In all, Dr. G has offered a list that includes costs of care for trial participants, ethics of providing a drug in a trial that is not available outside of the trial, and associated increases in cost and participant enrollment.

One may be tempted — indeed, I have been tempted — to jump to critique, to cite Adriana Petryna’s research about ‘flexible ethics’ and not take Dr. G seriously. These concerns, diverse as they may be presented, are all ultimately about resources and finding more efficient ways to conduct clinical research, which definitively involves providing less than the currently-accepted ethical standard of prevention. It is also true that these trials will mostly be ‘off-shored’ — mostly, to Peru and Brazil. So it is entirely fair to suggest what we see here are flexible ethics at play. We, in fact, may. But what I hope to show in this paper is that the critique and the context don’t match. There is something else at stake here. This is not just any clinical research — this is HIV science.

To understand HIV science, one needs to attend to the complicated and ever-evolving relationship between HIV treatment and HIV prevention that disrupts potential for a firm ethical stance about the science, how it is conducted, and under what conditions. Briefly, two considerations demand our attention. First, the ethical standard of prevention being considered here is access to treatment — both, treatment used for treatment as well as treatment used for prevention. It needs to be recognized that the stakes of treatment and prevention are different. They always have been. It is only because treatment has begun to subsume prevention and prevention has begun to resemble treatment that this interesting conflation of ethics is allowed to happen. Second, we need to take very seriously Dr. G’s concern that providing the deemed-ethical standard of prevention, Truvada as PrEP, has the potential to completely confound a vaccine trial. How should we think about these ethics?

I explore this question by highlighting Dr. G’s dilemmas — by paying attention to the relationship between clinical research for HIV prevention and global health programs for HIV treatment. What I provide here is no more than a medium-sized window into how complicated the debate over HIV treatment and HIV prevention has become and may continue to be.

In my larger project I am developing three central observations. First, global health programs for HIV treatment have forged an ethic of hope constructed around a universal standard of access. Second, clinical research for HIV prevention is made to assimilate to the ethics and logics set in place by treatment. And third, this arrangement has created an ethically fraught space that may be well described through the analytic of “danger!” In this paper, I briefly hover over my first two observations, and delve into my third point — the one about ‘danger!’ As a conceptual tool, danger is helpful for me in conversations that move beyond critiques of risk and ethical variability to a less critical understanding of ethics and affect.

The central ethical concern — the concern of access — has deep roots in the history of HIV, AIDS and activism. It emerges from the availability of drugs and the dynamics of global markets as well as the severe inequalities revealed in the ‘cleavages’ between the two. Paul Farmer has illustrated similar inequalities through his concept of “structural violence”. In his work, Farmer points to ways history and political economy have, in large part, determined disparities in health and access to treatment. This is an important perspective. In this paper I’m interested in understanding how concepts like structural violence are framed ethically to call for global intervention and universal ethical standards, especially for access. This call for intervention is delivered with the strength of political affect. Such affect can be heard in the words of President Obama who recently expressed commitment to “ending the AIDS pandemic – once and for all” (The White House 2011) and read in the new blueprint for PEPFAR, which is entitled “Creating an AIDS-free Generation.” It provides further support for access to life-saving treatments. I suggest the drugs, policy, money, affect and ethics necessary to deliver HIV treatment forms the foundation of a large and complicated global apparatus — what I will refer to as the “treatment apparatus”. The treatment apparatus is robustly constructed around an ethic of access and hope — one that communicates global responsibility, places faith in U.S.-based interventions, and imagines the ‘end of AIDS’.

My thoughts about the treatment apparatus are informed by theories of affect, and an aspiration to articulate a concept of ‘hope,’ but even more by Joao Biehl and Vinh-Kim Nguyen. In the work of Biehl and Nguyen we find assessments of global markets and careful accounts of how a sovereign state must work in relation to these markets, how politics of access are negotiated, and the ways citizenship is reshaped — how citizenship is crafted in political, biological and therapeutic ways. Biehl and Nguyen also provide insight into how the intimate lives of people — people with the will to live — are ensured through emergent forms of governance — pharmaceutical governance (Biehl 2004), and the governmentality of ‘experimental communities’ (Nguyen). Importantly, these forms of governance, too, are constructed around treatment, and access to it. The ability to provide access becomes a defining quality of the sovereign state.

I hold these thoughts in mind as I think carefully about the ethics Dr. G is grappling with in clinical trial design. Earlier I introduced my argument that ‘flexible ethics’ are not the appropriate analytic for this context. To carry this point further, I piggyback on Johanna Crane’s thoughtful research in which sovereignty is complicated once again. Crane has opened for inquiry the ethically fraught space of ethical variability and emphasized the greater reach of inequalities — spanning from global capital to nation-state sovereignty; from patients who are at-risk to the scientific enterprise as risky, and importantly also, from US-based researchers to researchers in countries that remain under-represented in science — namely, Uganda. I suggest Crane’s analysis aligns well with the projects of Nguyen and Biehl in so much as the conditions of the nation-state, and its very sovereignty are given attention. I also suggest we can place Dr. G’s project along this theoretical line to evaluate the ways ‘access’ operates, imagine other ethical possibilities, and engage with the sovereignty of HIV science.

Meanwhile, to use Petryna’s critique — to accept that universal ethical standards should always be enforced, for it is the moral thing to do — in large part, does not appreciate sovereignty. As I quickly approach a conclusion I find it important to note that Petryna’s work on clinical trials is the only piece of research I am discussing that is not squarely focused on HIV science and politics. This simple observation again emphasizes how difficult it is to work in the field of HIV science. I suggest that Dr. G’s diligence to identify and evaluate the ethics of future clinical trials for HIV vaccines, her attention to who has access to important treatments and who benefits from prevention science are not amenable to more general critiques concerning ethics of trials based in an appeal to universal standards. To understand Dr. G’s dilemmas, we need to delve deep into the spaces where ethics are negotiated. We need to appreciate HIV science on its own terms. We need to think not only of the sovereignty of a nation-state or a global apparatus, but also of the sovereignty of HIV science. And to do all this, we need an analytic of ‘danger!’

Thank you.