2.5 Ethical issues in international biomedical research
2.5.8 Standard of Care
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of HIV transmission from infected pregnant women to babies in wealthy developed countries (Schüklenk, 2000). However, AZT was expensive, costing approximately US $800 per pregnancy, and thus unaffordable in poor developing countries such as those in Sub-Saharan Africa where governmental healthcare budgets are often less than $10 per person per year (Resnik, 2001). Yet it is in those less developing countries where the prevalence of HIV is high with approximately more than 60% of new HIV infections and 90% of all maternal-foetal HIV transmission occurring in sub-Saharan Africa (UNAIDS, 2015). Therefore it is clear that Sub- Saharan Africa is where safe, effective and affordable HIV prevention interventions are much needed.
In 1994 international agencies such as the US National Institutes of Health, WHO and UNAIDS designed placebo-controlled controlled trials aimed at testing the effectiveness of a short-course treatment of AZT (which would cost only $80 per infected woman), compared to the standard of care in developing countries, of no intervention at all to prevent HIV infection of new-born babies (Lavery et al., 2007; Schüklenk, 2000). In these trials, control participants were offered placebo treatments, despite the existence of effective AZT therapy in developed wealthy countries (Angell, 2000; Lavery et al., 2007). Lurie and Wolfe (1997) heavily criticized these placebo-controlled trials (Angell, 1997). Their primary argument was the use of double standards for poor and wealthy populations, implying that researchers from developed countries were using trial designs (i.e., placebo controlled trials) for HIV pregnant woman in developing countries when the very same design would have been deemed unacceptable in the sponsoring developed country (Angell, 1997; Crouch & Arras, 1998; Lurie & Wolfe, 1997).
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However, other commentators argued that the critics failed to understand the scientific, social and economic contextual complexities of the AZT trials in developing countries (Forster,
Emanuel & Grady, 2001; Lie et al., 2004; Varmus & Satcher, 1997). For instance, Resnik (1998) argued that these placebo-controlled trials for AZT in 1997 were morally justifiable based on the local standards of care for those countries. In other words, it was ethically permissible to provide placebo to the control group since no alternative treatment was available locally.
Furthermore, supporters of the placebo controlled AZT trials maintained that the use of placebo control posed potential benefits rather than risks to the trial participants. Considering that no treatment was the standard of care for the prevention of mother to child transmission of HIV in those developing countries where AZT trials were conducted, proponents argued that participants assigned to the control arm were not deprived of any treatment they would otherwise have
received (Selgelid, 2005; Varmus & Satcher, 1997). That is to say, if the participants had not enrolled in the AZT trials, ordinarily they would not have received any interventions to prevent HIV transmission to their babies in any case, given the existing economic and infrastructural constraints of the local contexts. Indeed, the participants who were assigned to the treatment arm in addition to free HIV counselling, benefited by receiving treatment that could reduce the risk of HIV transmission to their babies. On the other hand, those in the placebo group also benefited from free HIV counselling and education. In addition, they were not harmed because they were not denied any effective treatment entitled to them had they not participated in the AZT trial (Selgelid, 2005).
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Abdool Karim (1998), in his South African viewpoint paper published in the American Journal of Public Health, argued that the use of placebo in the AZT trials in South Africa was ethically justifiable given the local economic and infrastructural constraints. Abdool Karim was
emphasizing one of the arguments in defence of the AZT placebo controlled trials –that no locally available therapy was being withheld from participants in the placebo control group.
While many commentators advocate for best available standard of care worldwide to research participants (Angell, 1997, 2000; Lurie & Wolfe, 1997; Rothman & Michels, 1994; Shapiro &
Meslin, 2001), others argue that this may impede valuable research in developing countries (Studdert & Brennan, 1998). Wendler et al. (2004) proposed a framework delineating the conditions under which it is acceptable to provide research participants with less than the best methods. They recommend that IRBs or RECs should apply a default of requiring the best interventions available anywhere in the world, in all cases. However, the authors concede that there are exceptions to this default requirement in certain circumstances, specifically when proposed research satisfies four conditions: “(1) scientific necessity: investigators must use less than the worldwide best methods to answer the scientific question posed by the trial, (2)
relevance for the host community: answering the scientific question posed by the trial will help address an important health need of the host community, (3) sufficient host community benefit : the trial will produce a fair level of benefit for the host community, and (4) participant and host community nonmaleficence: participants and the host community will not be made prospectively worse off than they would be in the absence of the trial” (Wendler et al., 2004, p. 927).
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Lignou (2011) argued that the fundamental human right to health and the moral principle of justice should form the moral basis for the standard of care debate in developing countries.
Similarly, Marouf and Esplin (2015) argued that the duty of justice and the basic human right to health as international human rights principles are pertinent to the standard of care debate in developing countries, particularly where limited resources mean that the local standard of care is no care at all. The authors maintain that applying a human rights framework may help define a middle ground that recognizes the practical challenges arising in providing the best worldwide intervention while also setting a minimum standard of care for control groups. In the authors’
view, the framework of human rights law, in particular the core obligations of the right to health, might help establish a minimum standard of care (Marouf & Esplin, 2015).