The No-Brainer Syndrome

Alexander Sanger

Both male circumcision and the new HPV vaccine have been called "no-brainers" in the fight to reduce HIV and HPV infection rates. But are they really the magic bullet solutions that they seem to be?

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.

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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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