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September 2003 Public Health HIV/AIDS Journal Club
Nicola Stanley. HIVAN Networking and Sectoral Research Team. 19 September 2003.
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?“Access to treatment and other controversial issues in HIV preventive vaccine trials?” was the theme of the September 2003 Public Health HIV/AIDS Journal Club presentation given by Ms Catherine Slack at the Nelson R Mandela School of Medicine, University of KwaZulu-Natal. Ms Slack is the Co-ordinator of the HIV/AIDS Vaccine Ethics Group (HAVEG) at the University of KwaZulu-Natal in Pietermaritzburg.
Ms Slack opened by referring to the context of the South African ethics debate on access to HIV/AIDS treatment. Fundamental to this debate is the awareness that some participants might acquire HIV infection during the course of the trials. This will never occur through exposure to the trial vaccine, but a probability exists that trial participants might become infected through high-risk sexual behaviour. This could occur during each of the three phases of the trial process, which are designed respectively to assess the safety, immunogenicity and efficacy of HIV vaccines, notwithstanding the provision of high quality risk-reduction counselling throughout the trial, or the low-risk status of Phase 1 participants, in particular.
Ms Slack noted the confusing nature of the terminology characterising this debate internationally, including ?“standard of care?”, ?“highest attainable?” and ?“best proven therapeutic method?”. These terms have also characterised the debate in South Africa. She emphasised the role that has been played by the South African AIDS Vaccine Initiative (SAAVI) in stimulating debate through sponsoring fora since as early as 2000 to review central questions and issues. Topics covered at these fora have included the obligations of funding agencies to trial participants who become infected, and mechanisms to enable access to treatment in South Africa.
It is clear that a number of considerations attach to the concepts of care and treatment, including: Risk reduction counselling, psychosocial support, spiritual care, prevention and treatment of opportunistic infections and anti-retroviral therapy (ART). South African debate about what trial participants should receive if they become infected during a trial has largely focused on ART in the context of limited access to quality treatment, including ART in public sector.
Speaking to processes geared to foster deliberation to date, Ms Mandisa Mbali of the Enhancing Care Initiative (ECI) raised the issue of how the ethics debate plays out in our multi-cultural society, and is characterised by differences and inequalities in gender, class and power relations. Ms Slack noted the importance of engaging communities in such debates, and the challenges of developing the capacity of all stakeholders, including communities, to participate meaningfully and to negotiate around these complex issues. She also observed that the debate in South Africa could have been enhanced by sound social science data on the expectations of communities in relation to vaccine trials.
With regard to the role of sponsors in treatment provision, the core question addressed in the presentation was: On what grounds should sponsors provide treatment? Ms Slack described two possibilities:
Firstly, she referred to a hypothetical scenario wherein trial participants have false beliefs about the ability of a vaccine to protect them (a ?“therapeutic misconception?”) and increased high risk behaviour (?“behavioural disinhibition?”). In this scenario, the question for debate is: Can HIV infection be classified as a ?“research-related injury?”? And, therefore, are sponsors obligated to compensate these participants through provision of treatment?
In addressing this question, Ms Slack reviewed empirical evidence for changes in risk behaviour in HIV vaccine trials, noting that most studies fail to find general sustained increases in risk behaviour in such trials. Results from research on the comprehension of trial participants, including South African volunteers, does suggest that ensuring understanding of the trial objectives is a challenge (see Kilmarx, et al., 2001). For example, South African research has shown that the majority of participants in a microbicide trial believed that the research agent could protect them from sexually transmitted infections, despite intensive informed consent procedures having been applied.
The second question raised by Ms Slack was: Will ensuring access to treatment for vaccine trial participants encourage a fair distribution of research-related risks and benefits? And, if so, should sponsors be obligated to provide such treatment?
In addressing this question, Ms Slack noted that while research often provides benefits (including knowledge or products, capacity-building and trial-related health care), the provision of health care beyond that required for the conduct of research (i.e. treatment for HIV infection) remains a controversial issue and could be viewed as falling outside the scope of traditional risk-benefit distribution assessment.
However, it could be further asked: Should international research initiatives be used to reduce inequalities in health care between collaborating nations? An answer to this question is that the provision of high quality treatment to trial participants will, in fact, introduce research-linked inequalities in access to treatment between trial participants and community members. Hence: does comprehensive treatment for a few represent the best use of finite donor resources?
Ms Slack said that it is difficult to argue for sponsors bearing a mandatory ethical obligation to treat infected trial participants, and that one of the simplest proposals for sponsor provision of treatment is that of ?“positive beneficence?” - the morally praiseworthy route. She commented that there is no consensus internationally on whether or not sponsors are obligated to provide treatment to trial participants who become infected while in HIV prevention trials.
Another question that complicates the issue is: Will the promise of high quality treatment be an ?“undue inducement?” causing trial participants to ignore or devalue their concerns about risks? It is possible that participants might also accept the offer of improved health care through self-interest.
Prof Matjila raised the issue of payment for trial participation and the notion that some participants regularly participate in trials for payment, sometimes exposing themselves to risks. Ms Slack replied that potential risks attach to any research context, and that it becomes difficult to ensure that payment reflects fair compensation for time and inconvenience.
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