The No-Brainer Syndrome


Dr. Paul Offit, director of the Vaccine Education Center at The Children's Hospital of Philadelphia, called the new HPV vaccine, Gardasil, approved last year by the Center for Disease Control (CDC), "a no-brainer." Many advocates in the blogosphere use the same phrase, "no-brainer," to describe the World Health Organization (WHO) 2006 recommendation for male circumcision as an HIV/AIDS prevention strategy, at least in sub-Saharan Africa. Most health professionals agreed, even if they didn't use the exact phrase.

The public disagreed. A mere 10% of girls in the U.S. have been vaccinated so far with Gardasil and few men in Africa have had "the snip." Within the past weeks the Virginia Legislature has taken steps to repeal its mandate for the HPV vaccine for schoolgirls, and the Health Minister of South Africa has refused to endorse male circumcision as part of its national AIDS program.

So, are these recommendations "no-brainers" or not?

They aren't, for three reasons: 1) they might not be as effective as advertised; 2) they run the risk of diverting funds from more effective prevention strategies; and 3) there is a real risk of unintended harm to women.

Both epidemics, HPV and HIV, have certain similarities: both are viruses, both are transmitted sexually, and both flourish because of the molasses-like pace of change in the human sexual behavior needed to thwart them. The US government's ABC (Abstinence, Be faithful, Use Condoms) approach has been effective in some countries in Africa and elsewhere, especially where it resulted in more condom use, but alas, condom use is not universal for many reasons – cultural, sexual, economic and otherwise, including the prosaic fact that the worldwide condom supply is both erratic and insufficient. Alas, even when condoms are available and used, they are not universally effective against HPV/genital warts. And, significantly, the U.S. and the world have failed to ensure access to Pap smears for the world's women. Thus HPV and HIV march on.

In desperation the public health establishment embraced two seeming magic (and expensive) bullets in the fight against HPV and HIV: a new vaccine and a re-branding of circumcision.

The HPV Vaccine: Gardasil

Gardasil is recommended for young females, preferably ages 11-12, who are not yet sexually active and hence not already infected with HPV, though it has been approved by the FDA for all females ages 9-26. In clinical trials for the 16-26 year old age group, Gardasil was virtually 100% effective for five years against the four strains of HPV that it targets (there are over 100 strains of HPV). Yet parents did not rush to get their daughters vaccinated.

Aside from safety, effectiveness and cost issues, some parents and public health officials had additional concerns:

1) Efficacy – while the vaccine does protect against HPV-16 and HPV-18 (the strains that cause 70% of cervical cancer), by so doing the vaccine may be unleashing other HPV strains which can infect the woman – thus, the ultimate efficacy of the vaccine against all HPV infections and, ultimately, against cervical cancer may be less than the initial studies indicated;

2) Misallocation of Funds – money to pay for Gardasil as part of the Medicaid program or some other government program would have to come from somewhere, perhaps leading to a reduction in health prevention or treatment of HPV itself. There is an argument that whatever millions are spent on HPV vaccination might be better spent on a more comprehensive STI prevention program, including condom use and more extensive Pap screening.

3) Risk Compensating Behavior – conservative groups argued, only somewhat disingenuously, that HPV vaccination would inevitably lead to adolescents engaging in more, earlier and unprotected sex, thereby causing more transmission of HPV and other sexually transmitted infections. Vaccinated, and unvaccinated, adolescents might have a reduced fear of contracting HPV, and might thus engage in more and riskier sex. This is known in the public health world as "risk compensation," and occurs when there is a perceived change (i.e. reduction) in the risk of acquiring a disease or being involved in an accident, for instance with drivers with seat belts and air bags driving faster. The fact that there is still a multiplicity of sexually transmitted infections out there (including other HPV strains) that Gardasil does not prevent, and thus that there should be no false sense of immunity, has not dissuade these conservative groups from their campaign. This argument might be, in theory, a valid concern, but remains unproven.

Male Circumcision

In 2007 the World Health Organization announced that it was recommending male circumcision "as an efficacious intervention for HIV prevention."

Circumcision has a long and often contested history – socially, culturally, medically and religiously – which the WHO was well aware of, yet in 2007 two studies, one in Kenya and one in Uganda, were halted early by medical authorities, when the preliminary results showed a 53% and 51% reduction in risk respectively in acquiring HIV infection by circumcised males as opposed to uncircumcised males. The case for circumcision was so clear that it appeared to be a "no-brainer," even though scientists have no proof of how circumcision might actually work as an HIV preventative. Possible explanations include the keratinisation, or extra layers of skin forming on the penis, that occurs after circumcision serving as a retardant to HIV transmission, or the susceptibility to HIV in the Langerhans cells in the inner foreskin. Langerhans cells are immune cells which act as a reservoir and replication site for the HIV-1 virus. They also appear in other parts of the male and female genitals, including the clitoris. There was no suggestion by WHO that these cells, or the surrounding skin on the organs that contain them, be excised. The WHO circumcision recipe for the goose is not one for the gander.

Some policy makers raised similar objections to circumcision as those raised against HPV vaccination:

1) Efficacy – the WHO itself emphasized that circumcision was not 100% effective, and that, in fact, the HIV infection rate in circumcised males in the African clinical trials was still unacceptably high. There was no evidence that male circumcision protects female partners, or the partners of men who have sex with men. Both these sad facts have been born out by subsequent trials. Circumcised men who are HIV positive transmit the virus to their partners at the same rate as uncircumcised men. In fact, there was an observed increase in infection in the female partners of circumcised men who commenced sexual intercourse before their circumcision wounds had healed, despite extensive counseling of the couples to abstain until they got a go-ahead from a nurse.

2) Misallocation of Funds – some public health officials argued that a more effective use of funds was the current armament of HIV prevention strategies, such as ABC, especially the "C." It is hard to imagine an effective public health campaign that urged circumcision and continued condom use – why should a man go through circumcision if he still has to wear a condom?

3) Risk Compensating Behavior – there is a real prospect of an increase in risky sexual behavior by those circumcised, including reduced condom use and more sexual partners. In Africa the widespread male dissatisfaction with condom use and a desire for multiple partners and large families would likely be the chief motivators for males to seek circumcision in the first place, so that they would have a ready excuse not to wear condoms.

A final danger for women is that there might be a conflation of male circumcision with female genital mutilation, especially if the theory of the Langerhans cells (which appear in both the foreskin and the clitoris) is proven. The conflation in some parts of the world of male and female circumcision as a cultural marker or initiation rite is already problematic. It would be horrific if the call for more males to be circumcised in cultures where it is not practiced led to more female genital mutilation.

HPV Vaccination and Male Circumcision: Case Studies in the Failure of Public Health

So, here we have two new, expensive public health recommendations relating to sexually transmitted infections, one for females and one for males. Neither is a "no-brainer." Each is less than 100% effective, and has the real possibility of greater harm: Gardasil if the vaccination unleashes other HPV strains and circumcision if males have sex before the wound heals and if they embark on more partners without wearing condoms. Each risks draining resources from other prevention strategies, and each could harm women especially.

Cervical cancer can be caught and cured with pap smears, and HIV by a comprehensive ABC program. HIV in Africa is mostly transmitted by female prostitutes. Thailand embarked on a program to require condom use in brothels. Africa has not. The HIV prevalence rate in Thailand is now far lower than in Sub-Saharan Africa. ABC can work. The circumcision recommendation is, I believe, more a comment on the world's failure to implement ABC than on the benefits of the procedure, just as the HPV vaccine recommendation is a sad commentary of the U.S. and the world's failure to have a comprehensive public health system that gets Pap smears to every woman.

The foregoing is abridged from a longer article of the same title that can be found at www.AlexanderSanger.com.

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  • http://www.circumstitions.com invalid-0

    You make excellent points. In addition -

    • The randomised clinical trials were not double-blinded or placebo controlled (admittedly hard to achieve for an external operation, but more could have been done in that direction, and that is the gold standard) laying them open to experimenter and experimentee effects, and both the scientists and subjects were keen that circumcision should be efficacious.
    • Several times more men dropped out of the trials, their HIV status unknown to the experimenters, than were known to be infected. If more circumcised men dropped out when they found they had HIV (as you would), the results could be null and void.
    • The trials assumed all transmission was sexual, even though some of the men who seroconverted said they had not had sex, or only protected sex. Transmission by dirty needles is known to be widespread in Africa.
    • Sex between men was ignored, and probably much underreported.
    • The same keratinisation of the glans that allegedly protects men from HIV could make them less willing to use condoms.
    • According to the National Health and Demographic surveys, in six African countries (Cameroon, Ghana, Lesotho, Malawi, Rwanda and Tanzania), HIV is more prevalent in circumcised men than non-circumcised. This certainly needs to be explained before mass circumcision programmes are “rolled out”, or they could have the reverse of the desired effect.

    Circumcision has been a “cure” looking for a disease for a very long time. All the previous claims have been discredited; we should be doubly suspicious of this one.

  • invalid-0

    Thank you Alexander, for bringing a brain to this debate!

  • invalid-0

    There is great confusion about what the 60% reduction in HIV transmission actually means.
    It is widely quoted that circumcised men have a 60% less chance of contracting HIV, while others claim that the nature of the trials in South Africa, Uganda and Kenya were such that a group or community of circumcised men are protected by a factor of 60% with some men receiving no protection at all. This means that 40%, about half, of men who are circumcised don’t receive any protection at all: the claimed partial protection being a partial group protection and not an individual one. This confusion needs to be clarified.

    Great play has been made about the langerhan’s cells that exist on the mucosal tissue of the inner [inside] foreskin and their role in the transmission of HIV from an infected woman to a man – hence the reason for removing the foreskin altogether. The fact that the external female sexual organs also contain an abundance of langerhan’s cells must be the cause of much consternation at a time when there is a worldwide push to eliminate female circumcision globally. Female circumcision, also known as Female Genital Mutilation (FGM) is already a criminal offence in the UK, US and a number of African countries and so it should be. Although this not the place to detail them I also have strong reasons for believing that the same criminality should be extended to male circumcision – see my article ‘Circumcision in not a ‘cure’ for HIV’ supporting Dr. Joseph Marare, Aids Officer, Namibia http://zimdaily.com/news/117/ARTICLE/1291/2007-02-03.html

  • invalid-0

    Excellent article! Very interesting and well informed. I’d like to add one remark. You said:
    .

    A final danger for women is that there might be a conflation of male circumcision with female genital mutilation.

    .
    A conflation of male circumcision (genital mutilation) with female genital mutilation (circumcision) is an entirely supportable and natural viewpoint. In fact, it is efforts to distinguish them that seem artificial and strained.
    .
    Damage done to the penis by male circumcision is not trivial. The consequent harms of childhood male circumcision are no less arguable than those of sunna, a very common form of FGM. Sunna typically involves removal of the female prepuce, which is a far less developed and specialized structure than it is in the male. Sometimes sunna involves the clitoris, but this too can be minor, consisting of a prick with a pin (or even rubbing with paprika).
    .
    The real question needing to be asked about any genital cutting is whether the procedure is given to a child, which is ethically unsupportable, regardless of gender, or as elective surgery to an adult, which is a choice that may reasonably be offered. The WHO has made absolutely no effort to prevent its recommendations for male circumcision from being transmogrified into calls for routine infant circumcision (RIC), not just in Africa, but around the world.
    .
    Ideological bias and gender partiality in the assessment of harms precipitated by genital cutting of children is endemic in medicine and law. The following quote from New Scientist reflects the kind of bureaucratic codification and absence of common sense which the WHO has applied to it’s position on FGM.
    .

    From around puberty onwards, Rwandan girls start stretching the labia minora using plant extracts with antiseptic and anti-inflammatory properties, with the aim of achieving a length of about 5 centimetres. The WHO considers this practice as a form of genital mutilation, but Koster and Price argue that it should be reclassified as genital modification. “We believe that there are cultural practices that are not harmful to women’s integrity and rights,” says Koster.
    .
    Their interviewees reported, and Koster and Price speculate, that labial elongation increases the sexual pleasure of both sexes. …
    .
    [http://www.newscientist.com/article/mg19726444.100-ultrasound-nails-location-of-the-elusive-g-spot.html]

    .
    As is so often the case, quasi governmental box ticking and sanctimonious moralizing have converged to form official policies on sexual behaviour, ignoring what people actually prefer to do in their own lives. Just as the uptake of Gardasil was hobbled by conservative groups unable to grasp that girls grow into women, and just as implicit support for RIC in the Middle East and America is linked irrevocably to the pathologizing of childhood masturbation, a campaign against FGM has mutated into a campaign against sexual pleasure.
    .
    The sense I get from your article is that sex education, condoms and respect for partners would, if liberally applied, go a long way toward slowing the current rates of sexual infection. Well done.

  • invalid-0

    You’ve offered no suggestion of how preventing HPV strains that cause 70% of cervical cancers could possibly “unleash” other strains. You keep using this word “unleash” without any explanation of whether this could mean that other strains could become more virulent in causing cancer, spread more easily when not kept in check by the strains prevented, or anything else. Therefore, your argument that the strains not protected against could be “unleashed” rests not on science or even on a testable hypothesis.

    Further, just as the availability of safe abortions has not been shown to cause any increase in risky sexual behavior, it is very unlikely that protection against four HPV strains would do so.

    I am taken aback that your article seems to forget the saying “an ounce of prevention is worth a pound of cure,” and that you seem to say that since cervical cancer can be cured if caught early, it need not be prevented. Having a cure is not a reason to forgo prevention!

  • invalid-0

    I am astounded that there is so much resistance to Gardasil in the United States. It is being distributed to Australian women under the age of 26. This public health initiative was introduced to Australia without fuss. I am amazed that there should be such controversy in the United States. As for circumcision, there is no problem if a grown man makes an informed decision about this bodily modification. However, there is an issue with this being done to children. The child’s parents might be keen on this genital modification, but it’s not their body that they are modifying.

  • http://www.nonviolentchoice.blogspot.com invalid-0

    Alexander,

    While I personally support access to Gardasil and male circumcision as preventive options, I do so only under conditions of fully informed consent & the social power to exercise that. You point out many issues that need to be included in informed consent.

    Thank you for advising caution, and doing so from a stance quite other than that of fearing women’s right to have “unpunished” sex.

    When something is touted as a magic bullet solution, we need to ask, “Is this rapid push for the sake of human need? Or for something else, like profit?”

  • invalid-0

    Excellent article you made some very good points. Especially with respect to HIV.

    • It is hard to imagine an effective public health campaign that urged circumcision and continued condom use – why should a man go through circumcision if he still has to wear a condom’s

      The Australian Federation of AIDS Organization’s realized this too in one of their recent publications that was distributed at at last year’s International AIDS Society Conference which said in part:

      “How a man factors the known risk reduction alongside the unknown variables into his sexual decision-making is the important thing. Unless he opts to use condoms with all sexual partners whose HIV status is positive or unknown, he remains at risk of acquiring HIV (and if he does this, there is no need to be circumcised for added protection).”

    • In Africa the widespread male dissatisfaction with condom use and a desire for multiple partners and large families would likely be the chief motivators for males to seek circumcision in the first place, so that they would have a ready excuse not to wear condoms.

      In fact there have been reports that the second point is already occurring, as if I am surprised. Perhaps the best quote from that article:

      “Mister, these Aids people have spoken for long about fighting the disease, but they had never come up with a practical solution as good as this one. Don’t have sex, don’t do this, don’t do that. Eh, man, how can a young man such as I forfeit sex, eh? And the condoms – where is the sense in putting on a condom when you are having sex? Sex is about feeling, and so no young person likes them!”

    I think what you are seeing here though is a shoot now and ask questions later attitude. It is very typical; no thought or ethical considerations. There has been a lot of progress made in Africa over the last decade with regard to HIV. In Rwanda, for example, the HIV/AIDS rate has fallen from 11% of the adult population in 2000 to 3% in 2007 using conventional HIV reduction strategies. In fact in Rwanda, as one example, circumcised men had a higher prevalence of HIV, 3.8% vs 2.1% for intact men. A realistic view is that circumcision in Rwanda (and many other countries) will likely have no impact on the HIV/AIDS situation or set it back due to dis-inhibition. The press, and the study authors, have acted very irresponsibly with regard to all of this; in fact they could very possibly wreck much of the work that has gone into getting people to practice safe sex and be responsible.

    Circumcision is a proposed quick fix to a seemingly insurmountable problem in third world countries where HIV prevalence is endemic. The problem with quick fixes though are they almost never work and usually make things worse but they appeal to those who want to shirk responsibility or not want to do the real hard work. Truthfully the perpetrators of circumcision in Africa will be lucky if they don’t make things worse than they all ready are.

    Recently, the Children’s Commissioner of the Australian state of Tasmania, Paul Mason, has gained the support of the Australian Medical Association to make non-therapeutic/non-religious circumcision illegal. The story can be found here and Mr. Mason’s press release can be read here. Hopefully he will succeed and then boys can enjoy equal protection as girls with respect to this issue.

  • invalid-0

    I’ll assume you mean adult male circumcision, Marysia. I’m sure you’ll agree that forcibly cutting children is not ‘non-violent’.
    .
    Anyway, I’d like to comment of abortion in relation to this article and your homepage, because I think it adds a dimension that’s missing.
    .
    All ethical choices are contingent and relative. They need to be made with genuine good will, and an understanding of who the vulnerable parties are, and what harms they may be exposed to. Dogmatic moral positions run counter to this, and I think abortion is a phenomenon that illustrates this well.
    .
    I’m not somebody who takes abortion lightly. When I was young, my girlfriend terminated a pregnancy and we both came to regret it. As it turns out, I’ve never had children and I’m not likely to now, since I’m nearly 50. I feel as if, at the time, an ideological pressure contributed to my allowing her to take that decision too lightly. I felt it was her decision, or her right, and I think she felt I didn’t care enough to object. Teenage pregnancy has been pathologized in my culture in a way that I now find quite offensive. Feminism has made people feel that having children is a failure and an impediment, which is very sad.
    .
    Conversely, I’m strongly committed to the idea that women should have dominion over the reproductive potential of their own body, and to deny girls and women the knowledge, resources and power to manage their fertility is at least as harmful (and therefore ‘immoral’) as abortion is. I don’t think women can be penalized for seeking abortions when they have so clearly and for so long been denied this dominion.
    .
    Effectively, I am convinced by the argument of ‘The Ciderhouse Rules’. Abortion is a sad fate for a pregnancy, sometimes even a tragic one, but it can also be the best of a bad lot, and to take a moral position against it based on abstract principles is really to be ethically blind to the pressing realities that drive the phenomenon in the first place. So I would fight tooth and nail for a woman’s right to have her pregnancy terminated, but I would also fight tooth and nail to have seen my own child born, if I had that opportunity over.
    .
    It’s just the same with Gardasil, and it’s the same with circumcision. Ideological and moral posturing is not the source of wisdom, it is a sinkhole into which wisdom falls, to be lost forever. What matters is that people are treated with respect, given the information they need, and allowed to make choices that suit them. When a child is circumcised, it is not the circumcision that offends me, it is the usurping of the child’s rights over his own body. It’s also my belief that an 11 year old girl is mature enough to participate in maintaining her own sexual health, and the influence of the religious right on Gardisil vaccination in the US, bannered under the propaganda of ‘family’ values, strikes me as being a similarly unprincipled attack on the welfare of a vulnerable group: children.

  • alexander-sanger

    A citation for the proposition for the potential unleashing of other HPV strains caused by HPV vaccination is as follows: George F. Sawaya, MD and Karen Smith McCune, MD, Ph. D, HPV Vaccination: More Questions More Answers,

    http://content.nejm.org/cgi/reprint/356/19/1991.pdf.

     

    This editorial states in part:

     

    "In contrast to a plateau in the incidence of disease related to HPV types 16 and 18 among vaccinated women, the overall disease incidence regardless of HPV type continued to increase, raising the possibility that other oncogenic HPV types eventually filled the biological niche left behind after the elimination of HPV types 16 and 18."

     

    Alexander Sanger