Male Circumcision and HIV

UPDATE: John J. Potteratt's article on learning from unexpected results in RCTs now available in pdf format

John J. Potteratt's article published in Future Medicine (Jan 2010), Randomized, Controlled Trials for HIV/AIDS Prevention in Africa: learning from unexpected results, is now available in pdf format at the link below.

Download RCTs for HIV/AIDS Prevention in Africa: Learning from unexpected results.pdf

AFRICA: More evidence women at greater risk of HIV from circumcised men

If you need a single, pointed example of scientists lacking common sense and of failing to grasp the totality of the circumstances, all you need is to examine a recent study published in The Lancet and authored by Maria Wawer et al. at the Johns Hopkins Bloomberg School of Public Health in Baltimore.

Wawer examined the rate at which the female partners of 922 men contracted HIV and then compared the circumcised men's rate of transmission with the intact men. Fully 18% of circumcised men's partners contracted HIV compared with 12% of intact men.

Despite this clear, unequivocal contraindication, the authors state that men should still be offered circumcision regardless of their HIV status in order to avoid the stigma associated with the perception (or reality) of having HIV. In other words, the authors suggest the stigma should be placed on men who choose the rational option to remain intact.

And then, just to be funny, the authors suggest all men be offered circumcision for the laughable, dangerous, and utterly counter-intuitive purpose of reducing the likelihood of circumcised HIV-infected men and men of unknown status from using their status to coerce women to have unprotected sex.

Download Wawer-study-circum-effect-on-women.pdf.

Link: Circumcising HIV-Infected Men Increases Transmission to Women

INTACT AMERICA LAUNCHES CAMPAIGN TO CHANGE THE WAY THE NATION THINKS ABOUT MALE CIRCUMCISION

Media Contact: Bob Liff at 917-438-4628, bliff@mrss.com
M+R Strategic Services

INTACT AMERICA LAUNCHES CAMPAIGN TO CHANGE THE WAY THE NATION THINKS ABOUT MALE CIRCUMCISION

SORAYA MIRÉ, SOMALI WOMAN WHO FIGHTS TO END FORCED FEMALE CIRCUMCISION, JOINS CAMPAIGN TO PROMOTE INTACT BODIES FOR INFANT BOYS

PAINFUL, RISKY REMOVAL OF HEALTHY FUNCTIONING TISSUE VIOLATES HUMAN RIGHTS OF BABY BOYS WHO CANNOT GIVE INFORMED CONSENT

FOR IMMEDIATE RELEASE
JUNE 22, 2009

A group of parents, pediatricians, health activists, and human rights attorneys today announced the launch of a nationwide campaign to change the way America thinks about male circumcision, arguing that painful and medically unnecessary surgery to remove healthy genital tissue from non-consenting baby boys violates medical ethics and human rights.

Intact America – which unveiled its informational and advocacy website (www.intactamerica.org) at a Manhattan press conference – was joined by Soraya Miré, the Somali filmmaker and activist who has become a global leader in the fight against forced female circumcision.

"The same universal human right to an intact body that I have fought for on behalf of women and girls must apply to boys as well, especially those who are too young to make an informed decision about the integrity of their bodies," said Miré. "We need to ask ourselves: How can it be wrong to surgically alter the genitals of a baby girl without her consent but okay to surgically alter the genitals of a baby boy?"

The Intact America campaign kickoff comes at a time when the Centers for Disease Control is reviewing studies of adult African male circumcision in the context of the HIV epidemic in Africa, with the goal of developing a recommendation to be released here in the United States.

"Studies of adult men in Africa cannot be used to justify subjecting non-consenting American baby boys to irreversible surgery that will remove healthy tissue from their genitals for the rest of their lives," said Georganne Chapin, Executive Director of Intact America. "Let young men make decisions about their own bodies, when they reach an age to make that decision for themselves."

"Before subjecting their newborn sons to painful, risky and irreversible genital surgery that is medically unnecessary, parents should ask themselves if they would do the same to their daughters," said Chapin.

Chapin was also joined at the press conference by two physicians – Dr. Robert Van Howe, a pediatrician, from Marquette, MI, and his wife Dr. Michelle Storms, a family practice physician and Assistant Professor at the Michigan State University College of Human Medicine.

"Physicians have an obligation to look after the well-being of their patients. The child is the patient, not the parent. Neonatal circumcision is definitely not in the patients' best interest," said Dr. Van Howe, noting that the surgery yields more harm than benefit for the baby boy who cannot give informed consent. "It is a violation of the child's most basic human rights, and a violation of a physician's oath to do no harm."

"As an adult, I can say yes or no based on informed consent," said Dr. Van Howe. "An infant obviously cannot do that."

Dr. Storms, who is also Research Director in the Family Medicine Residency Program at the MSU medical college, said she stopped performing circumcisions in 1988 when she could not ignore the fact that there was no medical justification for the surgery.

"I realized I was cutting off healthy tissue from a baby that couldn't say no," said Dr. Storms. "I wasn't treating or diagnosing disease. It violated my sense of ethics and everything I was taught in medical school about my obligation to heal the sick and do no harm."

"Clearly, circumcision is harming these infants," Storms said. "Physicians should just say no to neonatal circumcision."

Dean Pisani, a Texas businessman, made a $1 million commitment to assist Intact America's campaign after he and his wife, who did not know the gender of their children before their births, were pressured by his wife's obstetrician and doctors in Illinois hospitals to perform a circumcision if they had a son.

"My wife and I did our research and could find no rational or persuasive argument to subject a baby to surgery that had no medical benefit," said Pisani. "We came under pressure from doctors prior to the birth of both of our children, but none could substantiate the medical necessity to perform the surgery. The pressure from doctors was both inappropriate and indefensible."

Male circumcision is the most commonly performed surgery on infants in the nation, and one that is medically unnecessary.

The United States is the only industrialized nation (other than South Korea, which was influenced by the United States in the 1950s) that continues to circumcise a majority of baby boys for non-religious reasons, and it also has a higher rate of HIV infection than other industrialized nations.

If circumcision were an effective means to prevent potential HIV infection, logic would suggest that the U.S.'s high rate of male circumcision would yield a lower rate of HIV infection, but it does not. The only reliable means of preventing sexual transmission of HIV remains abstinence or use of a condom, not circumcision.

Approximately 75% of the men in the world are not circumcised and remain intact throughout their lives. Even in America, which continues to lead the industrialized world in male circumcision of infant boys, the rate of circumcision has dropped from 85 percent to less than 60 percent as parents learn facts that for years have gone unexamined. Intact America is working to promote awareness about the normal, intact body and the value of the male foreskin as a normal, sensitive and functional part of the body. The foreskin serves to protect the penis from injury and contamination, and also has a role in sexual pleasure, due to its specialized nerve endings and its natural lubricating function.

Doctors began routinely circumcising infant boys in the last decades of the 19th century, when it was viewed as a means to discourage masturbation, and the evils that were believed to be associated with masturbation. Claims over the years that circumcision prevents various diseases – including, in recent decades, sexually transmitted diseases – have been found to be mistaken or exaggerated.

The most common method of circumcision involves the infant being strapped to a board. In some cases, an analgesic is applied to the baby's pubic area to somewhat lessen the pain, but many circumcisions are performed with no pain control at all. A metal instrument is used to forcibly separate the foreskin from the head of the penis, and the foreskin is then cut off. The surgery takes up to 15 minutes. The open wound it creates is exposed to urine and feces for several days as it heals. In addition to pain, the baby is subjected to the potential complications that accompany any surgery including, as occurs more than 100 times annually, complications leading to death.

Lesser but more common complications include abnormal bleeding, infection of the penis, scarring resulting from the removal of too much skin or, in rare cases, removal or subsequent loss of the entire penis. A case in point occurred recently in Georgia, where a family won a $2.3 million judgment after a botched circumcision accidentally removed a third of their son's healthy penis.

No professional medical authority recommends routine circumcision as a medical procedure, including the American Association of Pediatrics, which has said there are no benefits associated with male circumcision to justify recommending it.

Sixteen states refuse to cover non-medically-necessary circumcisions under Medicaid. Nationally, costs related to circumcision exceed $1 billion annually.

Link: INTACT AMERICA LAUNCHES CAMPAIGN TO CHANGE THE WAY THE NATION THINKS ABOUT MALE CIRCUMCISION

More confounding evidence weakens conclusions of African circumcision RCTs

The Lancet has published an article (11/3/2008) that looked at "cell-mediated immunity" to HIV-1. They summarized their objective thusly:

Background Observational data and non-human primate challenge studies suggest that cell-mediated immune responses might provide control of HIV replication. The Step Study directly assessed the efficacy of a cell-mediated immunity vaccine to protect against HIV-1 infection or change in early plasma HIV-1 levels.

Statistics were collected on circumcision status in men because "cell-mediated" refers to immunity responses at the cellular level where HIV first challenges or enters the body. Foreskins or lack of them clearly are implicated.

It has been pointed out that whatever the objective of this study, certain characteristics of the subjects point to a couple of important points. Table 4 appears to show uncircumcised men in the placebo arm were significantly LESS likely to contract incident HIV infections (1.4% to 4.2% per year).  Whereas, in vaccine recipients, uncircumcised men had modestly (non-significantly) higher HIV incidence.

Also, people who were uncircumcised were significantly more likely to have higher immune response to Ad5 (see table 1). Does this suggest that circumcision has an impact on immune response to Ad5 and maybe to other pathogens? If so, this might point to some immune benefits with an intact foreskin -- for responding to HIV as well as other pathogens.

EDIT: The reason cell-mediated immunity has gotten attention recently is due to the fact that the Merck vaccine in question here failed miserably and intact men were widely reported to have been made more vulnerable by the vaccine. While that appeared to be true, the de Witte study [pdf], published shortly after the African circumcision RCTs, appeared to show a very strong and efficacious response against HIV infection from Langerin, a substance that comes from the Langerhans cells. These were the very cells vilified without evidence by the pro-circumcision forces that have promoted circumcision before and after HIV came along and who conducted the African studies, as the evil that circumcision excises and therefore reduces rates of infection. Clearly, it is more complicated than that and the evidence is far from settled or even fully collected or analyzed.

Download Buchbinder-Lancet-Mediated-Cell-Immunity

Reference

Lancet 2008; 372: 1881–93
Published Online
November 13, 2008
DOI:10.1016/S0140-
6736(08)61591-3

THANK YOU, Amber, for forwarding this piece and to whomever is responsible for spotting this data deep in the tables and providing the base analysis.

Doubts over circumcision find voice in the South Africa Medical Journal

Dr. Daniel Sidler, a presenter at the Genital Integrity 2008 conference, along with colleagues Drs. Johan Smith and Heinz Rode, have published an opinion piece in the South Africa Medical Journal descriptively entitled, Neonatal circumcision does not reduce HIV/AIDS infection rates.

I had the chance to visit with Dr. Sidler in Keele. He voiced the concerns that he writes about in his article. You can read it here. [Download SAOpinion.pdf].

The article is a comprehensive review broad overview of the published evidence and interpretation of circumcision in the area of HIV prevention. The primary points he covers are the lack of demographic evidence to support circumcision in the prevention of HIV, the poorly understood and vastly under-reported harms attendant to the practice, and the likely damage that implementation of circumcision will cause to the much more effective prevention efforts that have already shown massive improvement in countries, such as Uganda.

No statistically significant difference in HIV prevalence between circumcised and intact men, South African Medical Journal reports

The South African Medical Journal has published a new analysis of a subset of 3025 men. Circumcision did not appear to be associated with HIV status.

One third of men (35.3%) were circumcised. Being over 50, African, living in rural areas and speaking SePedi (71.2%), IsiXhosa (64.3%) were strongly associated with circumcision. The median age was significantly older for Africans (18 yr) compared to other racial groups (3.5 yr), p < 0.001. Among Africans, circumcisions were mainly conducted outside hospital setting. In 40.5%, circumcision took place after sexual debut; Two thirds of men were circumcised after their 17th birthday were already sexually active. HIV and circumcision were not associated (12.3% vs 12%). HIV was, however, significantly lower in men circumcised before 12 yrs (6.8%) compared to over 12 yrs of age (13.5%), p = 0.02. When restricted to sexually active men, the difference that remained did not reach statistical significance (8.9% vs 13.6%, p = 0.08.).

The difference between those circumcised at a younger age and those circumcised at a later age likely has something to do with socio-economic factors. This is essentially a demographic study. As in previous studies of circumcision viz STDs and other conditions, this study contradicts other studies, which in turn contradict this study, embodying the very definition of "irreproducible."

Edit: And in case it requires spelling it out, irreproducible means no meaningful association between the two variables under study.

Download Connolly et al. Male Circ Analysis.pdf

Demography vs. Epidemiology, Optional subscriptions coming

Michel Garenne writes an article on male circumcision and HIV in real world settings. He makes important points and distinctions, ceding some ground while effectively dispelling illusions that circumcision will save Africa. More soon ...

Meanwhile, you can download and read his article here: Download ajar2008garennelong_term_effect_of_male_circumcision.pdf .

Also coming up, an appeal to readers. Want to improve this site? Want to see original reporting? Want to contribute to independent media and support original content untainted by big media bias where present day John Moneys such as Robert Bailey and Daniel Halperin are allowed to position themselves, unchallenged, to create a new generation of David Reimers? Optional subscription opportunities are in the works ... Stay tuned for more info in the coming days and weeks.

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