Ethics, subjects, and proof
Wednesday, July 22nd, 2009 by Susan PietrzykI recently read a Plus News report entitled: Male circumcision does not protect women. There has been enough literature, media attention, and so on to see that male circumcision has been a hot topic over the years. My interest is not to disagree with the argument that male circumcision can, to a degree, reduce the risk of contracting HIV for that man. In fact, I support the idea of disseminating information and making male circumcision more accessible in Southern Africa. That is as long as the reduce aspect is thoroughly emphasized as male circumcision does not eliminate risk, the potential side effects are conveyed, and it is not an imposed procedure.
The questions I do wish to raise concern the lengths that are being taken to scientifically prove the relationships between black African male circumcision and HIV risk for black African men and women. And relatedly, the potential for unintended consequences when the path followed is such a rigorous and relentless insistence on absolute, detailed quantitative scientific proof. My overall concern is this. The Plus News headline I mentioned could just as easily read: Clinical trial comes to an end, 25 women contracted HIV. When I think about that alternative headline, my mind goes a couple directions. For all the big money that was spent on the trial, perhaps the money would have been better spent trying to ensure the 25 women (and others) did not contract HIV. And further, if the majority of men in the US were uncircumcised would the funders of scientific trials have the same comfort-level to round up some HIV-positive men, along with their HIV-negative female partners, and engage them in a trial knowing that some percentage of those HIV-negative American females will end up HIV-positive. I suspect not.
There are several things I’m getting at here, which relate to my uneasy feelings about trials concerning male circumcision in general and also the particular trial in Rakai District (Southern Uganda) highlighted in Plus News. Firstly, as part of the effort to scientifically prove that male circumcision reduces HIV risk, a trial immediately offers some men access to the procedure while others must wait until the study is completed. Secondly, in order to get the scientific proof, along the way, some of the subjects have to become HIV-positive. Thirdly, the scientific proof for the Rakai District trial is, to a degree, based on 159 Ugandan women honestly reporting that they had sex only with their partner over the trial period. Those three points raise a complicated set of ethical and methodological questions. Before I go any further, let me outline some of the parameters concerning the Rakai District trial as highlighted in the Plus News article (which draws on two articles in the 17 July 2009 issue of Lancet).
The two-year trial included 922 HIV-positive male subjects. At the start, 474 were circumcised, and the other 448 were not. Additionally, the trial included 159 HIV-negative female subjects, the partners of a subset of the 922 male subjects. There were 92 couples representing an HIV-positive circumcised male with an HIV-negative female partner. And 67 couples representing an HIV-positive uncircumcised male with an HIV-negative female partner. The couples were basically told to go about their lives, and involvement in the trial importantly provided a range of STI/HIV-awareness services participants might not have otherwise accessed (albeit likely intensely biomedical oriented awareness services). Follow ups were made at six-month intervals to ascertain if any of the 159 female subjects had acquired HIV from their male partners. Of the 92 couples involving a circumcised male, 18% (or 17 women) tested HIV-positive. Of the 67 couples involving an uncircumcised male 12%
(or 8 women) tested HIV-positive. Thus the conclusion, male circumcision does not reduce HIV risk for women. I know this is not exactly the case, but still. In a certain way one result of obtaining that scientifically proven conclusion is that 25 Ugandan women became infected. The researchers do not state as much directly, but do hint at this possibility. A number of the circumcised male subjects did not follow the advice to abstain from sex for six weeks following being circumcised (to let the wound properly heal). When that advice was not followed this was the window in which a greater number of women contracted HIV from their male partners. Thus an argument can be made that had the men not been circumcised their female partners would not have become HIV-positive.
I know many won’t like what I am writing. The trial itself did not infect 25 women. The trial itself was administered by a team of experts and was approved by numerous Ugandan and American ethical review boards. Additionally, many would tell me the advancement of scientific knowledge has always involved unintended consequences. And those consequences have to be put in the perspective of the greater good. But when it comes to clinical trials around male circumcision among black Africans, there are some particular and unique dynamics that don’t sit well with me. Particularly, when these types of trials are put in the bigger picture, I can’t help but wonder about the notion of engaging black Africans to be subjects for the advancement of scientific research when it is predominantly the Western world wanting to pursue said research. And ask. Are there multiple
(conflicting) ideologies at work in making the foreskin of a black African penis a form of difference that warrants scientific study?
To return to my earlier wording, the lengths that are being taken to scientifically prove. Awhile back, within a listserv discussion, I commented that I am frustrated by the trends PEPFAR, the Global Fund, Bill and Melinda Gates, etc. have ushered in, they are not entirely new, but it seems they are with such greater force than ever before. This incessant demand to prove things, particularly quantitatively. To my mind, and I’ll be blunt. Enough with the proof around male circumcision. It’s not a quantitative contest. I would argue that enough clinical trials around male circumcision have been conducted. It is now time to continue on with integrating the results into long-standing HIV/AIDS information dissemination and service provision efforts. Specifically along three lines: 1) Male circumcision reduces, but does not eliminate, HIV risk for men; 2) Male circumcision, like nearly all medical procedures, contains risks and requires post-operative care; and 3) Male circumcision is a possible option for informed/consenting adults.