HIV transmission in Africa: A plea for fairness

 In developed countries around the world HIV transmission from mother to infant has effectively been curtailed through the AIDS Clinical Trial Group Protocol 076 (ACTG 076).  However, this protocol is extremely extensive, and it requires the pregnant mother to take a lengthy oral regimen and get intravenous injections of the relatively expensive drug zidovudine, among other things.  Because of this, undeveloped regions of the world, such as parts of Africa, can neither afford this protocol nor do they have the proper facilities and personnel to implement it.  As a result, in most parts of Africa, HIV positive mothers don’t have access to any treatment or medications to stop the transmission of HIV to their children, and this is becoming an increasingly large problem.

 In response to this need, researchers from the World Health Organization are attempting to find cheaper and less intensive treatments (and most probably less effective) which can be implemented in Africa.  Of course, to test the effectiveness of these treatments, researchers have run clinical trials in Africa, and in them they have had one group that undergoes the treatment, and one group that gets a placebo.  This use of placebo control groups have led to great contention around the world, and critics claim that since an alternate, effective treatment (ACTG 076) is available the new treatments should be tested against that, so no one is denied treatment altogether.  This notion can find its roots in the Declaration of Helsinki, which states, “The benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods”.

Although this argument is valid in a country where ACTG 076 is available (because then a placebo control group would really be denying people treatment), it is not valid in a region where ACTG 076 is unavailable in the first place, because no one is being denied treatment they would otherwise receive.  In effect, in such a region there is no “best current treatment”, and in such cases, no one denies that a placebo group is ethical. And yet, critics still claim that the trials shouldn’t have a placebo group, and should have an ACTG 076 group instead, so everyone in the trial at least gets some sort of treatment.  But, objectively, this is no different than simply running the trials with a placebo group and then giving certain random people in Africa the ACTG 076 treatment – because either way the rest of the African population gets no treatment, and is, in a sense, a placebo group.  However, these same critics generally do not argue that we should give everyone in Africa ACTG 076. Thus, from this it becomes clear that it is not the placebo group in itself that is troublesome to critics but rather, the trials bring the blatant inequality in the world to the forefront.  The placebo group emphasizes the inequality between the African population and people in developed countries (who would get ACTG 076 rather than a placebo), and consequently people are more emotionally motivated to have an ACTG 076 group rather than a placebo group.

Admittedly, this social and economic inequity is indeed a problem that should be resolved, but it does not intrinsically make the use of a placebo group unethical, all it does is blur the issue.  Because the placebo group makes the inequity ever more visible, people jump to the conclusion that the placebo group is actually exacerbating the problem.  On the contrary, the very purpose of the placebo group is to alleviate the inequity by finding cheaper, more readily accessible treatments for African mothers.  As David Satcher, a researcher, notes, the use of the placebo group will make the trials more efficient and will give more definitive results.  Since the expectation is that the new treatment will be less effective than ACTG 076, if the control group is ACTG 076 then it will be difficult to tell whether the new treatment is better than nothing – further prolonging the development of new treatments, which actually exacerbates the inequity even more.

 Therefore, the use of the placebo group in the case of these clinical trials in Africa will actually help reduce the inequalities between Africa and more developed regions faster and more efficiently than if an ACTG 076 control group is used.  Of course, it would be fantastic if all pregnant women in Africa had access to ACTG 076, but the sad reality is that they don’t.  The sooner critics realize this, the sooner these women will be able to get access to at least some form of treatment. 

Sources

https://blackboard.princeton.edu/@@/664683C27709CA2175BB52BC68E90A1B/courses/1/WRI167_S2012/content/_1289369_1/background.pdf
https://blackboard.princeton.edu/@@/664683C27709CA2175BB52BC68E90A1B/courses/1/WRI167_S2012/content/_1289370_1/Complexities_of_Cond_1F6C72.pdf