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De:	Dozie Ezechukwu [ Profil ]
Sujet:	Fw: [af-aids] eDiscussion: Male Circumcision & Women - Further thoughts from Daniel Halperin
Envoyé:	Oct 10th, 2009 - 09:16:37

	Chidozie Ezechukwu Network of People Living with HIV/AIDS in Nigeria (NEPWHAN) CSO House 4 Jaba Close, off Arthur Unegbe Street Area 11, Garki, Abuja Tel: 09-3145507, 08036123842 Fax: 09-3145506 e-mail: eizod3 (at) yahoo.com,dozie (at) nepwhan.com ----- Forwarded Message ---- From: AF-AIDS To: AF-AIDS Sent: Fri, October 9, 2009 10:59:00 AM Subject: [af-aids] eDiscussion: Male Circumcision & Women - Further thoughts from Daniel Halperin eDiscussion: Male Circumcision & Women - Further thoughts from Daniel Halperin ************** [Mod note: Below, please find a response below from Daniel Halperin (Harvard School of Public Health). He has been following on other eforums where the MMC & Women ediscussions have been ongoing and he wrote a response to comment on many of the issues that have arisen. We are posting it here for your comment and consideration. It’s a long memo, but highly recommend to read through.] - - - MMC & Women - Further thoughts from Daniel Halperin ************* Dear colleagues, First, a "warning" that this message ended up being rather longer than I had hoped/intended it to be. There have been so many messages/questions posed, etc. about this topic lately that by the time I finished composing my "reply," it had really grown in length! (And even so, I haven't tried to reply to every assertion, question, etc that's been made; that would have made this reply even longer.) What happened is that some time ago I was invited by the list serve organizers, as an "expert" in this area, to post a reply, and have since been trying to keep up with the ongoing onslaught of messages on this topic... It's been rather challenging to keep up with all of them, and then to compose a meaningful "reply," because not only have I been extremely busy traveling and dealing with many other projects etc, but every time I felt nearly ready to send in my reply, a new round of messages/inquires would pour in!... And along those lines, I would like to first venture a (hopefully fairly brief) "editorial comment" about the barrage of messages on this topic. Imagine if, for the past many years, virtually no one had been talking at all about microbicides, and none of the major international organizations had hardly ever mentioned the subject, or convened meetings or reports on the topic, etc. Then, what would happen if WHO and UNAIDS et al suddenly announced that 3 clinical trials had found that a substance called a "microbicide" greatly reduced HIV risk, and that all African govs/NGOs, etc should suddenly tell all women to insert this compound into their vaginas each time before having sex?? I'm sure that, if this had happened, there would likely have been much confusion, questions, a mixture of excitement and skepticism, etc., etc.? Well, I think this is essentially what's happened with MC. Ten years ago I published a paper on this topic in The Lancet, along with my fellow epidemiologist and anthropologist colleague Bob Bailey, pointing out that there were already dozens of very compelling studies suggesting a strongly protective effect of MC for HIV infection. Although there was some media and other coverage, I believe there was very little in Africa. And the following year when there was a special session on MC at the Durban International AIDS Conf, again most of the coverage was in papers like the New York Times, and for the most part not in South Africa/Africa itself. (I remember the famous Zulu author/playwrite/sangoma Credo Mutwa saying, at a speech he gave at that 2000 AIDS Conference: "The biggest mistake we Zulus ever made was in stopping the practice of male circumcision; we must bring it back urgently or we will all perish from AIDS!...," yet again this type of comment/observation/advice was virtually ignored, from what I could tell at the time. The year after that a very important, large 5-country study was published in the US' leading medical journal (New Eng Journal), finding that women with circumcised partners had much lower rates of cervical cancer, but again this was mainly met with silence in the region... In fact, until a couple of years ago nearly all the major international health orgs (WHO, UNAIDS, PEPFAR, CDC, etc.) either totally ignored the subject of MC, or were generally quite negative/skeptical/disparaging in their remarks... It is my belief that if, instead, such orgs had treated MC in a fairly similar way as to how things like microbicides or vaccines have been treated -- i.e.., a perhaps "not yet proven" modality that nevertheless had "important potential" for prevention, and therefore should at least be DISCUSSED -- then perhaps these kinds of vibrant and important discussions, as you all have been having in recent weeks, could have been happening many years ago already?!! And if that had been the case, I believe that efforts to make safe/affordable/quality voluntary MMC services available in the region would probably be much further along now... Ok, sorry for the digression. Now to my main comments. While I generally agree with the call that "more research is needed regarding the implications for women of medical male circumcision," on the other hand I think it's also very important that people be made aware of the ALREADY EXISTING DATA. Thus, for example: 1) There are now some 50 published studies regarding the relationship between MC and HIV infection. Nearly all of them show a strongly protective effect. For those people who, for whatever reason, would like to "doubt" the evidence, yes, you can always find one or two "interesting studies" here or there (and these are nearly always of the weakest type, methodologically), just as someone who wants to dispute that smoking causes lung cancer can easily go online and find "conflicting evidence," or for example in my country (US) there are, pathetically, some people who still "doubt" the evidence on climate change. (Yet even our ex-President finally admitted otherwise, although tragically many years later than he should have...) 2) Importantly, the totality of the evidence suggest that not only is there a strong protective effect for men from being infected sexually by women, but that -- especially at the population level -- MC is VERY beneficial for women. Yet somehow this point isn't always being appreciated? Let me try to lay out some of the key data, as concisely as I can: a) In the female to male direction, it is officially concluded that MC reduces risk by about 60%. However, and without going into all the technical details, some of us believe that in fact this is a rather conservative estimate. There are a number of reasons (from observational evidence, from the 3 trials, etc.) that MC is probably more likely in the range of (roughly) 75% risk reduction for men, I believe. As just one reason why I say this, if you look at the evidence from the trials, there were a number of men who didn't report having sex during the trials (and for whom MC didn't -- not surprisingly -- offer any protection). If you look just at the men who reported risky sexual behavior (multiple partners, etc.), then the protective effect was much higher than 60%, overall. In the Orange Farm trial, the "as treated" risk reduction was 76%.... (Here's a short research letter on this point: http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0030065). When we say that, for example, condoms are about 80-90% effective, when always used (according to WHO/UN/CDC studies, etc), that data is not based on clinical trials, but on serodiscordant couple studies. Unfortunately, we only have one serodisc study (from Rakai, Uganda) which looked at MC, and in that trial zero (out of 50) circumcised men who had HIV pos partners seroconverted, over a 2 and half year period. Which would mean (using the same methodology as is used for the effectiveness of condoms) that MC was, in that one study, "100% effective." Of course that's not true, but the point is that if, hypothetically, a randomized trial could somehow be conducted of condom use, it is very unlikely (given some inevitable "noise" in the system, etc.) that it would find anywhere close to 80 or 90% protective effect. In other words, saying that condoms are "almost 100% effective while MC is only 60% effective" isn't quite accurate, scientifically... In any event, even the official 60% estimate represents a rather HUGE reduction. We have nothing else in the prevention tool kit (except for partner reduction) that even approaches this, in the actual scientific evidence, in terms of showing impact at the population level in generalized epidemics. b) Yes, condoms ARE more effective, but ONLY if they are ALWAYS used. And how many men -- how many people -- will use condoms, EVERY time, with EVERY partner they have (including their regular partner(s), for their ENTIRE lives? I'm sure there must be some people who do that, but from ALL the evidence we have, from everywhere in the world, such people seem to be extremely rare. (If anyone has any conflicting evidence to suggest otherwise, please send it to me!) We can jump up and down to promote correct and consistent condom use (and we should keep doing that), but at end of day human nature is human nature, and -- outside of certain contexts like sex work -- we will probably never get a majority of people, or probably anywhere close to a majority, to always use a condom. However, in most of the world (where the HIV epidemic is "concentrated" in nature) the most effective prevention approach IS to promote "100% condom use," especially for sex work settings -- it works! However, in the dozen or so countries in the world (almost all of them in southern Africa) which have truly GENERALIZED epidemics, i.e. where sex works plays a very small part in the overall epidemic, then such interventions (while still worth doing) aren't likely to have nearly as much impact. (This conclusion has been reached in a number of scientific papers and conferences, etc over the past few years; see for example the SADC Prevention Think Thank Report: http://www.sadc.int/attachments/news/SADCPrevBrochure.pdf Or this recent UNAIDS report: http://www.unaidsrstesa.org/files/u1/MCP_Meeting_Report_Gabarone_28-29_Jan_2009.pdf In countries such as where this UNAIDS/World Bank/Harvard hosted meeting was held this year (Botswana), there are few formal sex workers, and condom use for this is almost 100%, yet we see that the overall epidemic continues to be horrific in scale. (And by "sex work" I'm not referring to "transactional sex," which of course is very common in the region, and is a major factor. You CAN, with good programs, get most people to use a condom for formal sex work, but unfortunately not for situations where you have romantic, ongoing relationships between "regular/trusted" partners, and where gifts or even $ are exchanged....At least not consistent condom use.) Of course, we must continue to distribute condoms, and make them widely available, etc, but here's the question: what is more likely to prevent more infections -- at the population level over time -- an infection which is on the order of 80-90% effective when always used, or one which is "only" in the range of 60-75%, but is a PERMANENT, one-time procedure? (And PLEASE note that I am NOT in any way suggesting that MMC should "replace" condoms! On the contrary... I'm simply trying to respond to some of the assertions (and underlying assumptions) that have been made in these and some other exchanges lately...) c) Ok, so how does all this "help women"? First, let me start with what should be -- but for some reason often isn't -- an obvious and very important point. Which is that even IF MC does not DIRECTLY reduce HIV risk from men to women, it will INDIRECTLY have a BIG impact on women, especially over time. That is because, simply, if there are many less men infected with the virus, then over time many less women will be infected, b/c they will be less likely to have sex with an HIV pos man. An analogy at the individual level is condom use with sex workers. It would be erroneous to say that if a man uses condoms (consistently) when he goes to sex workers, but never wears one with his wife, that this is not protecting his wife. While it's true that he's not DIRECTLY "protecting" her by using a condom with her, if he's always using one when he goes outside the relationship, that is INDIRECTLY "protecting" her, do you see? So in the same way, if he gets circumcised and is still HIV neg, then he will be less likely to get infected, and thus likely to infect his partner. And in fact, this is exactly what we see at the population level, across almost all of Africa (with only a couple of exceptions, that can be explained readily in each case), which is that where almost all men are circumcised, the WOMEN also have much lower levels of HIV infection. We see this not only across countries, but usually inside them too. Thus HIV is much lower in northern Mozambique and Inhambane Province, where most men are circ’ed, compared to other parts of the country. And in Limpopo and E Cape HIV is lower among women than it is in KZN or Mpumalanga or NW Prov, etc. (The Jewkes et al study found that only about half of men in E Cape were actually circumcised, and among those who were their HIV prev was about 60% lower. Thus, and also because SA is a highly mobile society, no surprise that HIV prev among women in EC is still fairly high, even if not as high as in the parts of SA where few men are circed.) As 10 leading HIV scientists concluded in a paper on "Reassessing HIV Prevention" in the journal Science last year: "It is likely that over time MC, which has been called a "surgical vaccine," would protect more women, albeit indirectly, than nearly any other achievable HIV prevention strategy (19,20)." (Link to that paper can be found at: http://www.hsph.harvard.edu/faculty/daniel-halperin/#Science-reassessing-HIV-prevention And along similar lines, modeling studies by researchers from UNAIDS, the World Health Organization and other orgs. have estimated that scaling up such services for the many men now seeking the procedure could, eventually, save millions of lives -- at least half of those among women -- as well as billions of dollars spent on the treatment of HIV-infected people. Now, even after having said all that about the "indirect" benefit for women, it's also possible there IS, in fact, a direct HIV benefit to women from MC too. Unfortunately, we will probably never know that for sure, because it would be very difficult to design a trial to prove that. There was, as many of you know, a trial in Uganda (funded by Gates F.) which attempted to look at this, but there was not sufficient enrolment, so they didn't have the "statistical power" to find an effect one way or the other. (And by the way, there has been a lot of confusion about that Uganda study! Many media reports, etc have said things like "The Rakai study shows that MC does not help women," etc, when in fact the study simply could not find an effect! "The absence of evidence is not the same as evidence of absence." Also, there was a VERY SMALL indication that men who resumed sex early may have had higher risk of passing HIV on to their female partner, but this was nowhere even remotely near statistically significant, and could easily have been due to chance. Of course, we should be concerned about this potential risk, but this HAS been studied already: a more recently published study pooled data from all 3 of the clinical trials, and there was a (statistically significant) finding, which was that there was NO increased risk to women of resuming sex early. But let me say it again: we need to be sure that men/couples are counseled not to resume sex early. I'm just reporting what the data has, in fact, already found. Also, an earlier study (though not a clinical trial) also from Rakai DID find a (statistically significant and rather large) apparent protective effect, among HIV pos men who were circumcised and had low viral load (as most did), for their female partners. So although as I said we will probably never know for certain, it's certainly POSSIBLE that there is, in addition to the (huge) indirect benefit for women, a direct benefit as well. What WAS found, in all of the trials, was a (significant) reduction of some OTHER STIs, incl HPV (which causes cervical cancer), BV, Trich, etc. And in the Rakia (Gates funded) clinical trial I mentioned, even with the small #s there was a (significant) reduction in genital ulceration among women whose (HIV pos) male partners got circumcised. 3) Another issue that was raised in some of the postings concerns (African) women's views of MC, in terms of hygiene, sexual pleasure, etc. As someone said, something like sexual "pleasure" is by nature "subjective," yes that's true. But, don't we need to listen to and respect what women themselves say about what they like/don't like/prefer?? And in every study I've seen on this so far (and there are quite a few out there now), the majority of women say that, all things being equal, they prefer having a circumcised partner. Hygiene is often cited, as is sexual pleasure. When I was living in Swaziland some years ago, and helping FLAS to develop their pilot MC project, we interviewed both men and their partners about MC, including some time afterward. A lot of the women would say, with a smile or giggle, that "things are much better now," and I've met many African men who told me the main reason they went for MC was b/c their female partner urged him to. In fact, some African women have told me they feel this is becoming a kind of "female controlled" method! :-) Someone had earlier sent out a blurb about the Orange Farm site, which contained this part: The opinions of female partners appeared to carry weight. "A friend of my wife's brought his son here, so my wife told me, 'Why didn't you do this thing before?'" said Phineas Soko, 48. "Some nations do this thing, but us Zulus know nothing about this." Soko gave in to pressure from his wife and friends. "I see some of the guys say you're supposed to cut this thing [because] sometimes you catch diseases," he told IRIN/PlusNews. Younger men thought women preferred sex with a circumcised man - 40 percent of women surveyed by Bophelo Pele did in fact say they preferred circumcised men, but their reasons had more to do with hygiene than sex...." Now, if anyone wants to see any of the various studies on women's perceptions and experiences with MC in Africa, pls let me know and I can send them... [*Mod note: They are also available on the MC Clearinghouse at http://www.malecircumcision.org/ ] 4) Now, there was some discussion earlier on about trad MC vs MMC. You may have noticed that I've been using those the terms "MC" and "MMC" fairly interchangeably. That's because -- although there are important differences and implications re quality of care, surgical safety and outcomes, etc -- however in terms of the HIV effect it is true what Kelly Curran said earlier, that there isn't any evidence (or reason to believe) that trad MC would be any less effective than "MMC", IF the entire foreskin is removed. And that's an important "if," because we know that in some places, like Lesotho fro example, only a symbolic nick is usually done instead of an actual MC in the traditional ceremonies, so it's no surprise that HIV is not lower among "circumcised" men in Lesotho .... 5) Another important point, which I've hinted at already, is that I believe it's a mistake, perhaps a rather large one frankly, to be talking about MC too much in terms strictly of HIV prevention. I've been feeling/saying this for a while now, for a number of reasons. In brief I think it's pretty clear, from a lot of studies now at our disposal, that most men (and women!) surveyed in areas of Africa where MC is no longer customarily practiced believe that MC is a "good" thing, something that is desirable, and that the main reasons are in fact not mainly b/c of HIV, but rather the widespread belief that circumcised men are "cleaner," that sex is better (for both partners) if men are circumcised, etc. (And BTW I'm only talking about Africa here! I know that if such studies were conducted in Europe or Australia or somewhere, that other kinds of findings would be brought in!...) In any event, my point is that (perhaps somewhat ironically, given what I have just been detailing the strong impact on HIV for both men and women) that I agree with what Marion said earlier re "I like the notion of men's sexual health as the overarching concept to introduce MC." (And by the way part of the problem is that sexual health/"RH" was, as we all know, greatly suppressed/ignored under the previous PEPFAR admin., and some of us have been battling to have RH, for both genders, more included under current policies, funding, etc... FYI I and two colleagues have a paper appearing soon in AIDS on the use of family planning to greatly improve the impact of HIV prevention programs.) In any event, clearly there is much demand now for safe and affordable MC services. Thousands of men seeking the procedure - despite virtually any promotional efforts -- have been flocking to Orange Farm, site of one of the circumcision trials. When men enrolled in a recent vaccine trial in Durban were offered the procedure, some 75% of them opted for it. At public health facilities in several other countries such as Zambia and Lesotho, wait lists continue to grow longer for this "elective" procedure... 6) Re the issue of MC and men who have sex with men, it's not accurate, I believe, to simply say that "MC doesn't help MSM." I could say a lot about this subject too, but since this message is already getting very long, let me simply paste in here a recent article about a study from Soweto: Circumcision Reduces HIV Risk for Some Gay Men, Research Shows By Simeon Bennett July 20 (Bloomberg) -- Circumcision, shown to reduce the risk of catching HIV in heterosexual men, may lower the chances that men who penetrate their male partners during anal sex will get the virus, a new study suggests. Researchers from the University of California San Francisco surveyed 378 men who had sex with men in South Africa. Among those who said they were always the insertive partner, uncircumcised men were 4.5 times more likely to have HIV than circumcised men, according to results presented at the International AIDS Society conference in Cape Town today. Africa is home to two-thirds of people living with HIV/AIDs, World Health Organization data show. The researchers' findings contradict those of some U.S. studies showing circumcision didn't help prevent HIV from spreading in sex between men. One possible explanation is those studies mainly involved men who were both giving and receiving anal sex, obscuring the benefit for those who were always the penetrating partner, said Daniel Halperin, a global-health lecturer at Harvard University. "This is an important study because it's not from the U.S. or Europe; it's from Africa," Halperin said in a July 17 phone interview. "Medical circumcision isn't going to have a big impact on the epidemic in the U.S. because most men aren't exclusively insertive." Of the 378 men surveyed in Soweto, near Johannesburg, 76.4 percent said they were always the insertive partner in sex with other men, said UCSF's Tim Lane, who presented the findings at the conference. Similar studies may yield the same result in nations such as Zimbabwe and Botswana, where behavior patterns among men who have sex with men mirror those in South Africa, Lane said. HIV Rate Among the men who were uncircumcised, 10.5 percent had HIV, compared with 3.9 percent for those who were circumcised, according to the study. Researchers disagree about whether circumcision should be recommended for exclusively insertive men in Africa before results of the Soweto study are confirmed in a randomized trial, which would take several years. Such a trial would be "extremely difficult" and may be of purely academic value, said Robert Bailey, a professor of epidemiology at the University of Illinois. "There is now such strong evidence that circumcision has so many benefits for men and women in addition to HIV prevention that it would be good public health practice to introduce circumcision for infants and early adolescents widely," Bailey said in an e-mail. Lane and colleagues said such a trial should at least be considered. Further Proof "We've got some evidence. Let's get some more," Lane said in an interview in Cape Town yesterday. "I would hesitate to offer these men anything that smacked of a magic bullet." Circumcision is the surgical removal of a flap of skin from the tip of a man's penis. The WHO, the Bill & Melinda Gates Foundation and the U.S. are supporting circumcision clinics in African countries, after three large studies showed the procedure can lower heterosexual men's risk of infection by almost two-thirds. The pocket between the foreskin and the tip of the penis gives viruses and bacteria a spot to grow, and circumcision eliminates it. Researchers have said the foreskin has also been shown in studies to be rich cells that carry HIV into the body. Other research has suggested circumcision wouldn't help gay men in rich nations such as the U.S. A study published in the Journal of the American Medical Association last year showed that while circumcised gay men were 14 percent less likely to be infected with the AIDS virus than uncircumcised men, the difference missed the level needed to show that it wasn't the result of chance. Investigating men who were always the penetrating partner in gay sex may yield different results, researchers from the Atlanta-based Centers for Disease Control and Prevention, who led the study, said at the time. To contact the reporter on this story: Simeon Bennett in Singapore at +65-6212-1574 or sbennett9 (at) bloomberg.net - - - And here's a similar study from Australia: Circumcision reduces HIV by 89% in insertive-only homosexual Sydney men AIDS. 2009 Sep 11. [Epub ahead of print] Circumcision and risk of HIV infection in Australian homosexual men. Templeton DJ, Jin F, Mao L, Prestage GP, Donovan B, Imrie J, Kippax S, Kaldor JM, Grulich AE. aNational Centre in HIV Epidemiology and Clinical Research, The University of New South Wales, Australia bRPA Sexual Health, Royal Prince Alfred Hospital, Australia cNational Centre in HIV Social Research, The University of New South Wales, Australia dSydney Sexual Health Centre, Sydney Hospital, Sydney, Australia. OBJECTIVE:: To assess circumcision status as a risk factor for HIV seroconversion in homosexual men. DESIGN, SETTING AND PARTICIPANTS:: The Health in Men (HIM) study was a prospective cohort of homosexual men in Sydney, Australia. HIV-negative men (n = 1426) were recruited primarily from community-based sources between 2001 and 2004 and followed to mid-2007. Participants underwent annual HIV testing, and detailed information on sexual risk behaviour was collected every 6 months. MAIN OUTCOME MEASURE:: HIV incidence in circumcised compared with uncircumcised participants, stratified by whether or not men predominantly practised the insertive role in anal intercourse. RESULTS:: There were 53 HIV seroconversions during follow-up; an incidence of 0.78 per 100 person-years. On multivariate analysis controlling for behavioural risk factors, being circumcised was associated with a nonsignificant reduction in risk of HIV seroconversion [hazard ratio 0.78, 95% confidence interval (CI) 0.42-1.45, P = 0.424]. Among one-third of study participants who reported a preference for the insertive role in anal intercourse, being circumcised was associated with asignificant reduction in HIV incidence after controlling for age and unprotected anal intercourse (UAI) (hazard ratio 0.11, 95% CI 0.03-0.80, P = 0.041). Those who reported a preference for the insertive role overwhelmingly practised insertive rather than receptive UAI. CONCLUSIONS:: Overall, circumcision did not significantly reduce the risk of HIV infection in the HIM cohort. However, it was associated with a significant reduction in HIV incidence among those participants who reported a preference for the insertive role in anal intercourse. Circumcision may have a role as an HIV prevention intervention in this subset of homosexual men. - - - [….Back To Daniel’s Thoughts…] 7) Ok, in conclusion, I certainly agree that male circumcision is not a "magic bullet" for AIDS prevention (nor, for that matter, is any other approach to date), given that it is not 100% effective and, especially if promoted too aggressively for HIV prevention -- rather than as the more basic reproductive health service that it is -- there is a risk that some men may feel emboldened to continue practicing risky behavior. While I believe that such concerns must be addressed through counseling, media campaigns and other means, MMC represents a crucial development for HIV prevention. Thus the time has come to urgently expand clinical services for safe and affordable circumcision and to support other effective, but similarly often overlooked, prevention approaches in those parts of Africa gravely affected by this still deadly epidemic, like RSA. BTW -- and finally, I promise -- I have a question for anyone out there, re another subject, that has been raised however in this discussion on MMC. Does anyone have any data on actual use of female condoms by women in the general population? (And not just a small study of sex workers, for example, or of the #s of condoms distributed or sold, since that's not the same as actual use.) By the way, I'm certainly in favor of making all methods, including this one, widely available, but as I often get asked this question, and don't really know the answer, I thought this list serve might include people who might know? Some colleagues in Zimbabwe have told me they think that most of the FCs sold there are being used as bracelets (I've heard that myself while doing research there), but this is anecdotal and someone must know of some more solid data on it?? Ok, thanks for your attention, especially to everyone/anyone who made it this far in the message! :-) Sincerely, Daniel Daniel Halperin, PhD Lecturer on Global Health Harvard University School of Public Health Email: dhalperi (at) hsph.harvard.edu --------- Stay Connected - Speak your world! 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