Male Circumcision and HIV

Future Medicine: Male Circumcision is not the HIV vaccine we have been waiting for!

The May issue of Future Medicine carries an editorial authored by Lawrence W. Green of UCSF's Department of Epidemiology & Biostatistics, Ryan G. McAllister of Georgetown University, Kent W. Peterson of Virginia-based Occupational Health Strategies, and John W. Travis of North Carolina-based Wellness Associates.

The abstract to the aptly entitled article Male circumcision is not the HIV 'vaccine' we have been waiting for!:

Over the past several months, some researchers and health organizations [101] have proclaimed circumcision to be a compelling and important new HIV tool. A recent commentary claims that circumcision is “at least as good as the HIV vaccine we have been waiting for, praying for and hoping to see in our lifetimes” [1]. Thousands of African men now line up to get circumcised in the mistaken belief that it will save them from HIV, as some developing nations – lacking even rudimentary medical care and clean drinking water – rush to implement mass circumcision programs with encouragement and millions of pledged dollars from the US government [2, 102, 103]. In addition, there are calls for implementing mass neonatal circumcision [104].

The push to institute mass circumcision in Africa, following the three randomized clinical trials (RCTs) conducted in Africa [3-5] , is based on an incomplete evaluation of real-world preventive effects over the long-term – effects that may be quite different outside the research setting and circumstances, with their access to resources, sanitary standards and intensive counseling. Moreover, proposals for mass circumcision lack a thorough and objective consideration of costs in relation to hoped-for benefits. No field-test has been performed to evaluate the effectiveness, complications, personnel requirements, costs and practicality of proposed approaches in real-life conditions. These are the classic distinctions between efficacy and effectiveness trials, and between internal validity and external validity [6].

Campaigns to promote safe-sex behaviors have been shown to accomplish a high rate of infection reduction [7], without the surgical risks and complications of circumcision, and at a much lower cost. For the health community to rush to recommend a program based on incomplete evidence is both premature and ill-advised. It misleads the public by promoting false hope from uncertain conclusions and might ultimately aggravate the problem by altering people’s behavioral patterns and exposing them and their partners to new or expanded risks [8] . Given these problems, circumcision of adults, and especially of children, by coercion or by false hope, raises human rights concerns.

You can read the article online here. You can download it here: Download mcnotavaccine.pdf.

This article states the case very well. Among the bullet points presented:

• All three of the studies were halted early
• The durations of the experiments were short
• No long-term follow-up has been or can be done
• A large number of participants were lost to follow-up
• Many infections appear to be from nonsexual sources

Other important confounding factors considered:

• Condom use and safe-sex practices were repeatedly reinforced
• Participants were provided 2 years of free medical care
• Participants were paid to participate
• Participants were solicited who wanted to be circumcised, and who may, therefore, not be representative of the general population
• The trials were conducted in atypically sanitary and well-resourced settings that are unlikely to be replicated in mass African circumcision campaigns   

The authors conclude:

Regardless of whether circumcision might offer some heterosexual males a partial degree of protection from HIV, numerous other issues need to be thoroughly considered before instituting mass circumcision campaigns.

In short, given the large number of unknowns, confounding factors and lack of long-term follow-up in the three RCTs, it is premature to recommend circumcision as an HIV-prevention strategy. Much more evidence must be gathered on real-world efficacy of male circumcision as a prevention tool before mass surgeries are implemented.

An objective scientific assessment must be conducted to determine if the three RCTs are applicable in real-world settings. And, to determine the true cost of a circumcision campaign, there must be a comprehensive resource analysis of the plan. These mass circumcision costs also must be compared with the opportunity costs of funding ABC campaigns.

As part of these assessments, the very real risks of circumcision surgery, including directly increasing HIV transmission to men as well as indirectly increasing transmission to women, surgical risks such as hemorrhage, other infections, meatal stenosis, need for repeat surgery and even death, must be considered.

Finally, the value and function of the foreskin as an integral part of the male sexual organ [31] and the ethical issues surrounding such surgery, including informed consent, the possibility of coercion and the dangerous implications of conveying erroneous messages of HIV immunity, must also be carefully considered in any analysis.

ABC programs offer nearly full protection from HIV infection, yet even if circumcision’s effectiveness matches the 50–60% effectiveness the RCTs reported, it only partially protects men, does not protect women at all, and leaves women more vulnerable to unsafe sex practices being forced upon them.

Those promoting circumcision argue that circumcision is an additional tool that will ultimately reduce infections more than just relying on condoms, monogamy and abstinence. However, African males are already lining up to be circumcised, thinking they will no longer need to use condoms. Rather than complementing ABC programs, promoting circumcision will undermine the ABC approach by diverting funds and encouraging risk compensation behavior, ultimately leading to an increase in HIV infections.

The world community must cautiously review and carefully consider the long-term consequences of mass circumcision campaigns, from the risk of increasing deaths and infections to human rights violations. In the rush to save lives, many may instead be lost and human rights trampled in the stampede. Circumcision is not the panacea the world has been waiting for in the battle to stem the HIV crisis.

At long last, members of the academic and health policy community, a sector from which much of this is emanating, have stepped forward with a systematic analysis of the problems and issues associated with the widespread promotion of circumcision for the purposes of addressing the HIV epidemic. We need more like this one.

Swiss recommendations now state that HIV positives on effective anti-retroviral treatment not infectious

This post is coming a little late to the fore. Nevertheless, I still wanted to mention it briefly.

Swiss public health officials have issued new guidelines (original in French and German [pdf warning]) regarding the infectiousness of HIV+ individuals on effective anti-retroviral therapy. Basically, the new guidelines state that condoms are unnecessary in serodiscordant (one positive, the other not) couples under a narrow but widely applicable set of circumstances. These circumstances are:

• The HIV+ individual must consistently adhere to the anti-retroviral therapy regimen and the effectiveness of the therapy must be monitored at regular intervals by his or her treating physician according to officially accepted guidelines;
• The viral load must be below the limit of detection (<40>)
• The HIV+ person must not be suffering from any other sexually transmitted infections.

Again, under these very narrow circumstances, serodiscordant couples needn't use condoms during sexual intercourse. Read the English translation here [pdf warning].

This is in accord with a study presented at the Fifteenth Conference on Retroviral and Opportunistic Infections. That study concluded that provision of ARV therapy to African nations could reduce HIV infection over all by 90%.

[This post was picked up by Reuters through Blogburst.]

Study finds no protective effect in gay men from circumcision, so why are the authors still promoting it?

The stock response in the last two decades to the realization that circumcision has little to no value in public health and can be demonstrated to harm newborn males as well as adult sexuality has been to repeat old saws that it's cleaner, all the kids are circumcised, and that it's "healthier" in some as yet undiscovered way. And so Zohar Mor, Charlotte K. Kent, Robert P. Kohn, and Jeffrey D. Klausner have dressed up nothing to look like something to reinforce the point in the misleadingly entitled article Declining Rates in Male Circumcision amidst Increasing Evidence of its Public Health Benefit. The only thing to recommend their nothing-new-to-report [pdf] article is that they conclude:

Our findings, showing no significant differences between circumcision status and the risk of HIV or syphilis infection, are consistent with the importance of non-penile, rectal acquisition of those infections (or oral infection in syphilis) among gay men in the U.S. [22], rather than penile acquisition as in heterosexual intercourse, during which the foreskin may be exposed to HIV infection. Because large proportions of gay men practice both insertive and receptive anal intercourse [23], the ability to differentiate between different risks for HIV infection associated with sexual practices versus circumcision status is limited.

So there you have the real take home point: penile acquisition of HIV is but one method of acquisition among the highest risk group in the United States that cannot be separated out from other methods of acquisition. And hence, no value is realized from circumcision due to the diversity of sexual behaviors among men who have sex with men. This is wholly consistent with the study presented in Sydney, Australia at the International AIDS Society conference earlier this year. Due to the low prevalence of HIV among American heterosexuals this conclusion effectively pulls the rug out from under the prime justification remaining for routine circumcision in the United States, i.e. disease control.

So why do these authors dress up truths as lies by continuing to advocate circumcision? Only they know for sure. But the public needs to be aware of these junk scientists' intentions, which may be neatly summarized in their own words:

In conclusion, while a majority of men attending the San Francisco STD clinic were circumcised, there were large and steady declines in circumcision across all racial/ethnic groups since 1960. There were significant differences by racial/ethnic groups suggesting important socio-cultural factors related to decisions to circumcise newborn males. Given the recent evidence demonstrating the substantial potential public health benefit of male circumcision [refuted a few short paragraphs before] and our observed declines in circumcision rates, national organizations that promote circumcision policy should review current practice guidelines in responding to those trends.

Direct your comments to: Jeff.Klausner@sfdph.org; zmor@sph.emory.edu

Australian AIDS org says circumcision "has no role" in Australian context

The Australian Federation of AIDS Organisations has issued a briefing paper [html] with the telling headline, "Male circumcision has no role in the Australian AIDS epidemic."

Among the key points are:

• There is no demonstrated benefit of circumcision in men who have sex with men.
• Correct and consistent condom use, not circumcision, is the most effective means of reducing female-to-male transmission, and vice-versa.
• African data on circumcision is context-specific and cannot be extrapolated to the Australian epidemic in any way.

The first point is a reiteration of a recent study from Sydney that showed circumcision provided no protection for gay men. The second point is clear from the statements and caveats issued from the circumcision studies organizers themselves. The third point is clear from the key contextual attribute of all three studies, that the protective effect is in heterosexual couples in only one direction.

A high impact, succinctly written poster presentation given at this years's International AIDS Society Conference is available here [large pdf] and is worth printing in color for outreach activities.

Download Circumcision07.pdf

The French ask questions

A European reader has passed along this article [html] from the French National Council on Aids (Conseil national du SIDA). Apparently, there are some doubts being expressed while paying lip service to the emerging scientific party line viz circumcision as HIV prophylactic.

The questions are more  probing than I've seen almost anywhere else "official". However, the essential basic human right to an intact body and to the decision making process to part with said intact body seems to be missing. Let's keep the dialogue going and hope we see this missing piece of the equation addressed.

Download 07_05_24_rapport_circoncisions_eng.pdf

THANK YOU to Alistair Jenkins for this contribution.

"We have no idea, so why not?" conclude researchers

Continuing in the vein of biased research in the service of furthering American circumcision, researchers have published an article in PLoS Medicine targeting black  and Hispanic men. [I've touched upon this article before. However, Aidsmap and the US Centers for Disease Control and Prevention have chosen to give it new life by the former's reviewing the article in their new Circumcision News page after the latter's making a presentation of it at the Seattle STI conference. I suppose I'm now complicit in extending its life a little longer.]

Among the many absurd assertions, the authors state, "Adult male circumcision will likely have the largest impact in populations where circumcision has been rare." And where else would it have the greatest impact of whatever sort? Among populations where it has been common? What does that even mean?

Continuing:

They highlight findings from a study of men attending a Baltimore sexually transmitted infection clinic, which found that whilst circumcision was not associated with a protective effect throughout the whole clinic population, it was associated with a reduced risk of infection among men known to have had unprotected sexual intercourse with HIV-positive female partners. The risk reduction was approximately 55%, although the confidence intervals of this estimate were wide (0.22–0.97) (Warner 2007).

It's hard to even know where to start with these kinds of reports when they are so over the top. The bottom line is HIV is actually quite rare in all ethnic groups. It is markedly higher in comparison with the majority white population, but that hardly makes it high enough to  recommend circumcision even if the claims for the procedure panned out. The groups where HIV is actually high are in gay men and intravenous drug users. Anyone else is wasting a good piece of skin if he thinks getting circumcised will have any effect on his level of risk. [Edit: Not to suggest gay men or  intravenous drug users wouldn't also be wasting a good piece of skin, that being the point of this post!]

That being understood, it is simply incomprehensible that "whilst circumcision was not associated with a protective effect throughout the whole clinic population," the authors could then go on to recommend its consideration anyway. You, the researcher/presenter, find no consistent protective effect, but you conclude "why not?" That's not an objective scientist talking. That's a man with an agenda. As always, tell him how you feel [after you read the article and review the presentation of course]: the CDC presenter's email: dwarner@cdc.gov .

Aidsmap article after the fold.

Male Circumcision Pales Amid Variables and the Bigger Picture

A recent PLoS article [html] has made a persuasive argument that controlling for a single variable in the HIV epidemic can neutralize any potential benefit from male circumcision. The study suggests targeting said variable would be far more effective than a messy, ethically questionable, and expensive mass male circumcision campaign.

The study's author, John R. Talbott, concludes that the size of the female sex worker population and their operation outside any regulatory environment are the drivers of the epidemic rather than low levels of male circumcision.

I find it extraordinarily interesting that highly sexually regimented societies or those with a history of such regimentation, primarily Muslim and Catholic countries, have a relatively controlled level of HIV infection. Post-modern or areligious countries such as those of Northern Europe and eastern countries, many with a Buddhist tradition, have moved quickly to stem the tied of HIV infection, and therefore also enjoy relatively low levels of infection from successful anti-HIV programs.

Sub-Saharan Africa has neither the tradition of sexual regimentation nor the reality of a post-modern/Buddhist society. Wouldn't it be worth studying these problems of sociology to determine the drivers of the epidemic? Clearly, the Talbott article is a valuable contribution in this direction.

Download the Talbott_article.pdf

Male circumcision first, doctors and nurses second (or not at all): talk about the cart before the horse!

While the press is running around in circles trumpeting male circumcision as the breakthrough we've been waiting for, Africa goes on bleeding. Mark Dybul, the Global AIDS Coordinator for the US Department of State, has remarked that it takes some 200 circumcisions before a practitioner can be let loose to perform them unsupervised with reliable results. Meanwhile, the WHO and UNAIDS have endorsed the procedure and suggested affected high HIV prevalence countries take it up. And now we get further reports that Africa is "hemorrhaging" doctors and nurses and thereby exacerbating the HIV/AIDS epidemic. Talk about putting the cart before the horse!

The unspeakable truth that nobody wants to discuss is that the circumcision trials were all about American researchers justifying their existence and perpetuating male circumcision in the United States at a time of its decline here rather than about Africa's fight against HIV/AIDS. Given the choice between lifesaving condoms and male circumcision from inexperienced, overworked, sick medical staff who may not be doctors PLUS lifesaving condoms, any sane person (which Africans are implicitly not so considered) would choose the condoms and forgo the circumcision.

It's politics as usual.

Download the Healthcare_Worker_Report_05-2007.pdf. Read the IRIN story, next page.

New research complicates informed consent

New research published in the British Journal of Urology appears to demonstrate the damage to sexual function and sensitivity caused by circumcision. This new information will likely nix any idea of circumcision in the average consumer of cosmetic procedures. It undoubtedly will make it harder for a confused couple deciding by proxy, as is currently possible, whether to inflict the procedure on their newborn.

The study is available as a pdf file.

Download Sorrells_study_2007.pdf

THANK YOU to Norm UK for making this file available on their website.

Notebook: The real targets of the linking of HIV/AIDS and circumcision

I have said in the past that the sudden upsurge in interest and research in male circumcision as a prophylactic tool in HIV prevention has everything to do with lack of real progress in the area of vaccine research and political failure in rolling out the gold standards of prevention in highly impacted areas, namely sub-Saharan Africa.

That's a long sentence. But it neatly encapsulates the reason that the international community has accepted this research now when it has rejected the idea for the two and half decades since this disease's worldwide debut. Nevertheless, every push for circumcision in the history of the procedure has had ulterior motives underlying it, i.e. someone's or some group's agenda is served by it.

A confluence of factors has emerged in the last half decade or so to create the current state of affairs. Apart from the aforementioned failures of political (and humanitarian) commitment, it is no coincidence that America and Americans are principally behind this push, as they are behind nearly every overt ideological rooted movement of today, excepting religious movements. It is also no small coincidental matter that Americans are circumcised in the majority. How else could world organizations dominated by the United States, endorse a procedure that:

1. Has shown to be ineffective in real world settings;
2. Likely leads to greater HIV infection in young people [pdf];
3. Puts women at greater risk for infection;
4. Fails to address the most vulnerable, i.e. women; and
5. Ignores contrary evidence of the prophylactic properties of the foreskin itself [pdf]?

The fact is the practical problems with circumcision in Africa will greatly slow its adoption and likely portend harmful unintended consequences where it is adopted. Hence, I don't see Africa as the probable intended "beneficiary." The more likely goal, as in all politics, is not what it would at first appear.

The American circumcision rate has been falling for nearly two decades now. Perhaps the better question to ask is, Who is likely to be on the receiving end of this new push? Africans without resources or infrastructure to carry it out? Or Americans who may be scared back into conformity? I don't know. I'm just asking.