The Vital Importance of Implementation Ethics

Stuart Rennie and Frieda Behets's article, "AIDS Care and Treatment in Sub-Saharan Africa: Implementation Ethics," is a landmark work that highlights the particular ethical challenges of rationing AIDS therapy in this part of the world. They ask, "What ethical issues are raised by the implementation of AIDS treatment programs in developing world contexts?"

South Africa—the world's most HIV-infected country—may be a useful starting point to answer this question because it offers an example of how not to ration and implement an antiretroviral (ARV) drug program. More than 800,000 HIV infected individuals there meet the WHO-recommended threshold requirements for treatment. Despite this alarming statistic and the vast resources South Africa has at its disposal, the government has been slow to roll out ARVs. South Africa's president, Thabo Mbeki, has squandered valuable time openly questioning the link between HIV and AIDS, and its health minister, Manto Tshabalala-Msimang, has repeatedly labeled ARVs "toxic" while championing natural remedies such as beetroot, lemon, garlic, olive, and the African sweet potato in the fight against the pandemic. Anecdotal reports suggest her stance sows confusion and deters enrollment in ARV programs where capacity to absorb additional patients exists. Not surprisingly, the government is being blamed for mismanaging implementation of ARVs.

Despite these missteps, treatment of HIV-positive individuals can be maximized in a resource-constrained setting if the treatment program utilizes a drug regimen that meets three criteria. First, it must be inexpensive, which allows a greater number of needy individuals therapy. Second, it should be administered in a single dose, which facilitates adherence. And finally, it should require minimal monitoring, which results in lower laboratory-related oversight costs. Efavirenz, an established ARV drug, meets these criteria. It is also compatible with tuberculosis treatment—an important factor in sub-Saharan Africa, where up to 70 percent of HIV-positive patients are infected with tuberculosis. Efavirenz has accordingly become the backbone of first-line, highly active antiretroviral therapy (HAART) regimens in many resource-constrained settings, favored over nevirapine, another commonly-used anti-HIV drug. But prescribing efavirenz as part of a first-line HAART regimen raises ethical concerns.

Clinical reports suggest efavirenz may be harmful to fetuses. Often women of childbearing age do not understand this prior to enrolling in HAART programs. Further complicating things is the fact that, due to cultural and social factors, many women of childbearing age in the developing world have a hard time persuading their partners to use condoms. Accordingly, they run a greater risk of becoming pregnant, as well as HIV-positive, than do women in developed nations who have more control over their reproductive affairs.

On the other hand, treatment programs that stress efavirenz's risks have an ethical conundrum. Because of the possible side effects of the drug on fetuses, some programs require women to use both barrier and hormonal contraception as a condition of treatment. But women might agree to this due to desperate circumstances, rather than because they appreciate the long-term implications of the choice.

Some programs engage in a case-by-case analysis and prescribe a nevirapine-based regimen as first-line care if they suspect a woman runs a strong risk of getting pregnant. But in those instances when efavirenz-based treatment is the most viable alternative (for example, if the woman is of childbearing age but infected with tuberculosis as well), should lifesaving treatment be conditional upon mandatory contraceptive use? Under ideal circumstances, the answer is no. However, health workers in resource-scarce settings, faced with limited treatment options and a spiraling epidemic, may be rationing resources in this way.

Historical factors also impact implementation ethics. In South Africa, black women are suspicious of attempts to regulate their reproductive choices because of the government's attempts to do so during the apartheid era. Repeating this strategy today could deter needy women from seeking treatment. Proper counseling about the implications of either treatment strategy is the only ethical path.

Rennie and Behets deserve praise for characterizing "implementation ethics" and outlining the factors that precipitate them. As the scale-up of HAART intensifies, scientists, bioethicists, and...