The research assistant will work with the principal investigator Nir Eyal and collaborators from the Harvard TH Chan School of Public Health, Duke University, Massachusetts General Hospital, and the Brigham and Women’s Hospital as well as the ACTG HIV trial site network. The multidisciplinary team uses methods of clinical epidemiology, economics, simulation modeling, and normative theory to predict risks in early-phase HIV cure studies, assess how much likely candidates for participation understand those risks, and make ethical recommendations on the conduct of HIV cure studies.
The research assistant will help prepare, conduct and analyze a pilot survey expected to take place in a US site of the AIDS Clinical Trials Group (ACTG). The survey will assess perceptions of HIV cure and of cure study risks. The research assistant will also promote other research and grant-related activities, through literature reviews and assistance in the preparation of abstract, poster, and manuscripts for publication, grant applications, a simple project website (using Harvard’s user-friendly OpenScholar platform), and slides for lectures and seminars. The research assistant will be in touch with top researchers in HIV cure, medical decision making, and ethics from around the country, to facilitate our meetings, a workshop, and regular conversations to plan the research and debate ethical issues around early-phase HIV cure studies.
On Wednesday, South African Health Minister Aaron Motsoaledi announced that, as of January 2015, HIV-positive patients in the country would start receiving free antiretroviral treatment once their CD4 count fell below 500, instead of current threshold of less than 350. Some patient groups would start receiving antiretrovirals immediately upon being diagnosed with HIV infection, regardless of their clinical stage.
Last month, Till Bärnighausen, Dan Wikler and I predicted in PLoS Medicine that sub-Saharan nations would move in the direction that South Africa is now moving, and pointed out a big complication. This policy change might make several gigantic trials of so-called treatment-as-prevention in sub-Saharan Africa impossible to complete successfully. As we explained, these trials remain important for assessing the potential of treatment-as-prevention to curb the spread of HIV in general populations (with many different relationship types and different levels of care delivery and support).
In treatment-as-prevention, antiretrovirals are offered to patients immediately upon their diagnosis with HIV. The hope is that very early treatment would be better for these patients and prevent them from infecting others. We also offered some ways out of this mess, but they involve untraditional approaches to research conduct and to policy. Our piece was featured in the June issue of UNAIDS’ HIV This Month.
High hopes for overcoming the HIV epidemic rest to a large extent on HIV Treatment-as-Prevention (TasP). Large cluster-randomized controlled trials are currently under way to test the effectiveness of different TasP strategies in general populations in sub-Saharan Africa. At the same time, however, international antiretroviral treatment (ART) guidelines have already moved to definitions of ART eligibility including all – in the US guidelines – or nearly all – in the WHO guidelines – HIV-infected people. In this panel, we are bringing together the leaders of three TasP trials in sub-Saharan Africa, bioethicists, and public health researchers to debate the tension between the policy intentions expressed in these guidelines and the historic opportunity to learn whether TasP works or not. Please join us in considering different options to resolving this tension.
Till Bärnighausen, Harvard School of Public Health, and Wellcome Trust Africa Centre for Health and Population Science
Max Essex, Harvard School of Public Health
Deenan Pillay, Wellcome Trust Africa Centre for Health and Population Science, and University College London
Velephi Okello, Swaziland National AIDS Programme, Ministry of Health
Dan Wikler, Harvard School of Public Health
Nir Eyal, Harvard Medical School
Moderator: Megan Murray, Harvard School of Public Health and Harvard Medical School
In documenting how often public health law research does influence legislation, I’ve used syringe exchange programs as an example of evidence NOT guiding policy. Despite the consensus in health research that increasing access to sterile syringes has helped reduce HIV, state drug paraphernalia laws, and pharmacy regulations remain a barrier, as does the lack of strong and stable funding for the programs that are working. The case was just made again in an article in the Annals of Health Law. Rachel Hulkower and Leslie Wolf retell the story of the federal funding ban, going over the evidence yet again, and argue that state inaction would best be overcome with money: replacing the federal ban with a positive endorsement and real funding. (As long as we are in an optimistic mood, I would add strings – no HIV funding for states that don’t remove legal barriers to syringe access. This would balance the scales a bit for Congress’ past sin in requiring state recipients of HIV funds to provide for criminalization of exposure and transmission.)
But today I type to tell a happier story. This summer, the state of Nevada passed a statute authorizing syringe exchange and pharmacy sales. There are now 16 jurisdictions whose laws explicitly authorize syringe exchange programs (CA, CO, CT, DC, DE, HI, MA, MD, ME, NJ, NM, NV, NY, RI, VT, WA) and the number of states that require a prescription for retail purchase without exception has dwindled to ONE (Chris Christie’s New Jersey – Delaware, the other hold out, changed its law this year.) But the important thing is not the next halting steps in this slow trend, but the quality of Nevada’s legal contribution. This is going to get a little bit wonky in parts, but let me just take you on a quick tour of this marvelous statute, which drew from a model created several years ago by the Canadian HIV/AIDS Legal Network.
How to Survive a Plague is a moving chronicle of the onset of the AIDS epidemic as seen through the lens of the activists who mobilized to identify and make available the effective treatments we have today. Beginning at the start of the epidemic, when little was known about the HIV virus and even hospitals were refusing to treat AIDS patients out of fear of contagion, the film follows a group of leaders in the groups ACT-UP and TAG. Using existing footage interspersed with current-day interviews, it tells the story of how patients and concerned allies pushed the research community to find a way to treat what was then a lethal disease.
The film’s portrayal of the U.S. Government, specifically then-President George H. W. Bush and high ranking officials in the Food and Drug Administration, is damning. As hundreds of thousands of people became infected with HIV and the death toll rose, prejudice against marginalized groups (especially gay men, IV drug users) contributed to a lack of urgency about the need to learn how stop the spread of the virus and how to treat the opportunistic infections that killed people with full-blown AIDS. In contrast, footage of demonstrations, meetings, and conferences highlights the courage of the activists who risked and endured discrimination, beatings and arrests to bring attention to the need for more research.
But How to Survive a Plague is more than a documentary about the power people have to make change when they join together to demand action. It also is a provocative commentary about unintended consequences. I saw the film while attending the annual Advancing Ethical Research Conference of Public Responsibility in Medicine and Research (PRIM&R). In that context, I was especially interested in the way How to Survive a Plague highlights an interesting ethical issue in clinical research. Namely, the problem of protecting people so much from research risks that the protection itself causes harm. Continue reading →
The concept of “overcriminalization” is gaining traction across the political spectrum.
The Heritage Foundation, which has a website devoted to the phenomenon, defines it as “the trend in America – and particularly in Congress – to use the criminal law to ‘solve’ every problem, punish every mistake (instead of making proper use of civil penalties), and coerce Americans into conforming their behavior to satisfy social engineering objectives.” Others, like Michelle Alexander, drop the Ayn Rand tones and focus on mass incarceration as racialized social control. (My colleagues and I once calculated that African American males can expect to spend on average 3.09 years in prison or jail over their lifetime.) Douglas Husak argues that we need a theory of criminalization to help us get less of it.
One of the best examples of criminal law rushing in where angels fear to tread is the criminalization of HIV exposure. From the start, there was reason to fear that these laws would not reduce HIV transmission, and might exacerbate stigma and social hostility towards people with HIV. There was concern they might be used selectively, or just randomly.