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Ethics, subjects, and proof

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I 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.

4 comments to “Ethics, subjects, and proof”

  1. Comment by Don Cox:

    You missed number 4: Male circumcision can increase the risk of HIV transmission to women.

    The point about doing trials, provided they are properly conducted, is to get away from mere guesswork and “general impressions”. In this case the trial revealed a danger that was not previously known. I think that is important.

    How will the consenting adults become “informed” if there are no properly conducted trials to provide evidence for or against a treatment?

    One major problem is that very few people leave school with any understanding of statistics.

  2. Comment by Susan Pietrzyk:

    I did note that male circumcision can increase HIV risk for women. Went as far as to suggest that the Rakai District trial itself facilitated that risk because the male participants were unable to abstain from sex for six weeks after being circumcised. More broadly, I think you missed my point. I am not opposed to trials. Just that it’s important to recognize when the trials which have been conducted are sufficient. To date, trials around male circumcision have yielded some important findings. And part of these findings have been recognition that male circumcision does not provide a singular answer to a complex problem. Male circumcision reduces risk for some, to some degree. And increases risk for some, to some degree. Important then to ask: What is another trial going bring, and what’s motivating that additional trial? At some point it’s a matter of putting into context that no amount of trials around male circumcision will change the underlying human rights element. Male circumcision is not a procedure that can be imposed. If the plan for more trials is being motivated by the desire to build more quantitative evidence to argue for imposing male circumcision, this, in my view, would be a poor use of resources.

  3. Comment by Jack:

    I agree with some of the feelings expressed, but I feel that circumcision is surrounded by such myth and misinformation that either it should not be performed at all, or science must be involved. I am shocked by how Africans have accepted the studies as proving anything. The studies that say risk is lowered by 60% only had 50 -55% risk reduction and I think this is from about 3.2% risk to 1.79% risk. Would anyone say 3.2b bullets in a 100 shot gun to ones head is much different from 1.79 bullets in the same gun? Why are there many other studies that did not find the risk change and why are they not mentioned much? Could it be the pro circumcision agenda being pursued? If female circ involves the same type of cells and same chance for body parts to hold the virus, why is that not pursued? (American bias for MGM?) Why is it not noted that the Africa studies saying male risk reduction could be ooff by large % due to cut having less sex (to heal), condom advice and being humans trying to avoid HIV, after having the main male plasure zones removed (20,000 fine touch and stretch nerve endings).

    The latest study may understate the NEGATIVE impact of circumcision
    Certainly good science regarding the medical value of circumcision is hard to find because it is largely driven by pro circ fanatics. This study was undertaken by the pro-circumcision camp, funded by the Gates foundation.

    There is good reason to believe that the study, if it had continued, would have shown that circumcision actually increases the likelihood of female transmission significantly, if not by twofold.

    The data indicates that nearly 75% (6) of the women in the uncircumcised group, who became infected, were infected within six months. Only 2 (25%) of the remaining 62 women became infected over the subsequent 18 months.
    11 of the 94 women in the circumcised group became infected in the first six months, 5 of whom may have contracted HIV through pre-healed intercourse. Nevertheless, 6 additional women from this group became infected over the next 18 months.
    Excluding those in both groups who were infected in the first six months as aberrations, whether it be because of abnormal susceptibility or dangerous sex practices, the fact remains more than double the women in the circumcised group became infected over the next 18 months. When this is considered, in addition to the fact they also had the benefit of a 6 to 8 week abstinence window, which the uncircumcised group did not, there is every reason to believe that circumcision may greatly increases the chances of transmission in women.

    No one can question the fact that more than twice the women (17) in the circumcised group became infected than in the uncircumcised group (8), despite most having engaged in a significant abstinence period of nearly 2 months, as well. To say that these numbers are insignificant statistically is dubious. It is highly unlikely that the public health experts who undertook the study would have reached the same conclusion if the numbers had been reversed.

  4. Comment by Nancy Reyes:

    The headline and study was absurd.

    The reason HIV spreads is via thin mucus membranes and small cracks in the skin.

    Circumcision (or even a dorsal slit) allows men to clean, so that dirt and debris don’t accumulate under the foreskin and cause irritation that would allow HIV to enter tiny abrasions. It also leads to the skin of the gland being thicker, and less prone to being abraded.

    Ergo, circumcision leads to less HIV spread to the man.

    But there is no physiological reason it should protect women.

    Indeed, since the men might think they are now “protected”, the spread may increase to women via more illicit sex (the same reason that stressing condoms increases HIV spread, because it increases the number of sexual contacts).

    In contrast, traditional Muslims are both circumcized and avoid promiscuity.

    To decrease HIV spread to women, we need to encourage women to get medical treatment for their vaginal irritations, and also to encourage them to stop using herbs that make them “dry” (so that men will find sex more pleasurable)…