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.

Roundups Sexual Health

This Week in Sex: The Sexually Transmitted Infections Edition

Martha Kempner

A new Zika case suggests the virus can be transmitted from an infected woman to a male partner. And, in other news, HPV-related cancers are on the rise, and an experimental chlamydia vaccine shows signs of promise.

This Week in Sex is a weekly summary of news and research related to sexual behavior, sexuality education, contraception, STIs, and more.

Zika May Have Been Sexually Transmitted From a Woman to Her Male Partner

A new case suggests that males may be infected with the Zika virus through unprotected sex with female partners. Researchers have known for a while that men can infect their partners through penetrative sexual intercourse, but this is the first suspected case of sexual transmission from a woman.

The case involves a New York City woman who is in her early 20s and traveled to a country with high rates of the mosquito-borne virus (her name and the specific country where she traveled have not been released). The woman, who experienced stomach cramps and a headache while waiting for her flight back to New York, reported one act of sexual intercourse without a condom the day she returned from her trip. The following day, her symptoms became worse and included fever, fatigue, a rash, and tingling in her hands and feet. Two days later, she visited her primary-care provider and tests confirmed she had the Zika virus.

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A few days after that (seven days after intercourse), her male partner, also in his 20s, began feeling similar symptoms. He had a rash, a fever, and also conjunctivitis (pink eye). He, too, was diagnosed with Zika. After meeting with him, public health officials in the New York City confirmed that he had not traveled out of the country nor had he been recently bit by a mosquito. This leaves sexual transmission from his partner as the most likely cause of his infection, though further tests are being done.

The Centers for Disease Control and Prevention (CDC)’s recommendations for preventing Zika have been based on the assumption that virus was spread from a male to a receptive partner. Therefore the recommendations had been that pregnant women whose male partners had traveled or lived in a place where Zika virus is spreading use condoms or abstain from sex during the pregnancy. For those couples for whom pregnancy is not an issue, the CDC recommended that men who had traveled to countries with Zika outbreaks and had symptoms of the virus, use condoms or abstain from sex for six months after their trip. It also suggested that men who traveled but don’t have symptoms use condoms for at least eight weeks.

Based on this case—the first to suggest female-to-male transmission—the CDC may extend these recommendations to couples in which a female traveled to a country with an outbreak.

More Signs of Gonorrhea’s Growing Antibiotic Resistance

Last week, the CDC released new data on gonorrhea and warned once again that the bacteria that causes this common sexually transmitted infection (STI) is becoming resistant to the antibiotics used to treat it.

There are about 350,000 cases of gonorrhea reported each year, but it is estimated that 800,000 cases really occur with many going undiagnosed and untreated. Once easily treatable with antibiotics, the bacteria Neisseria gonorrhoeae has steadily gained resistance to whole classes of antibiotics over the decades. By the 1980s, penicillin no longer worked to treat it, and in 2007 the CDC stopped recommending the use of fluoroquinolones. Now, cephalosporins are the only class of drugs that work. The recommended treatment involves a combination of ceftriaxone (an injectable cephalosporin) and azithromycin (an oral antibiotic).

Unfortunately, the data released last week—which comes from analysis of more than 5,000 samples of gonorrhea (called isolates) collected from STI clinics across the country—shows that the bacteria is developing resistance to these drugs as well. In fact, the percentage of gonorrhea isolates with decreased susceptibility to azithromycin increased more than 300 percent between 2013 and 2014 (from 0.6 percent to 2.5 percent).

Though no cases of treatment failure has been reported in the United States, this is a troubling sign of what may be coming. Dr. Gail Bolan, director of CDC’s Division of STD Prevention, said in a press release: “It is unclear how long the combination therapy of azithromycin and ceftriaxone will be effective if the increases in resistance persists. We need to push forward on multiple fronts to ensure we can continue offering successful treatment to those who need it.”

HPV-Related Cancers Up Despite Vaccine 

The CDC also released new data this month showing an increase in HPV-associated cancers between 2008 and 2012 compared with the previous five-year period. HPV or human papillomavirus is an extremely common sexually transmitted infection. In fact, HPV is so common that the CDC believes most sexually active adults will get it at some point in their lives. Many cases of HPV clear spontaneously with no medical intervention, but certain types of the virus cause cancer of the cervix, vulva, penis, anus, mouth, and neck.

The CDC’s new data suggests that an average of 38,793 HPV-associated cancers were diagnosed each year between 2008 and 2012. This is a 17 percent increase from about 33,000 each year between 2004 and 2008. This is a particularly unfortunate trend given that the newest available vaccine—Gardasil 9—can prevent the types of HPV most often linked to cancer. In fact, researchers estimated that the majority of cancers found in the recent data (about 28,000 each year) were caused by types of the virus that could be prevented by the vaccine.

Unfortunately, as Rewire has reported, the vaccine is often mired in controversy and far fewer young people have received it than get most other recommended vaccines. In 2014, only 40 percent of girls and 22 percent of boys ages 13 to 17 had received all three recommended doses of the vaccine. In comparison, nearly 80 percent of young people in this age group had received the vaccine that protects against meningitis.

In response to the newest data, Dr. Electra Paskett, co-director of the Cancer Control Research Program at the Ohio State University Comprehensive Cancer Center, told HealthDay:

In order to increase HPV vaccination rates, we must change the perception of the HPV vaccine from something that prevents a sexually transmitted disease to a vaccine that prevents cancer. Every parent should ask the question: If there was a vaccine I could give my child that would prevent them from developing six different cancers, would I give it to them? The answer would be a resounding yes—and we would have a dramatic decrease in HPV-related cancers across the globe.

Making Inroads Toward a Chlamydia Vaccine

An article published in the journal Vaccine shows that researchers have made progress with a new vaccine to prevent chlamydia. According to lead researcher David Bulir of the M. G. DeGroote Institute for Infectious Disease Research at Canada’s McMaster University, efforts to create a vaccine have been underway for decades, but this is the first formulation to show success.

In 2014, there were 1.4 million reported cases of chlamydia in the United States. While this bacterial infection can be easily treated with antibiotics, it often goes undiagnosed because many people show no symptoms. Untreated chlamydia can lead to pelvic inflammatory disease, which can leave scar tissue in the fallopian tubes or uterus and ultimately result in infertility.

The experimental vaccine was created by Canadian researchers who used pieces of the bacteria that causes chlamydia to form an antigen they called BD584. The hope was that the antigen could prompt the body’s immune system to fight the chlamydia bacteria if exposed to it.

Researchers gave BD584 to mice using a nasal spray, and then exposed them to chlamydia. The results were very promising. The mice who received the spray cleared the infection faster than the mice who did not. Moreover, the mice given the nasal spray were less likely to show symptoms of infection, such as bacterial shedding from the vagina or fluid blockages of the fallopian tubes.

There are many steps to go before this vaccine could become available. The researchers need to test it on other strains of the bacteria and in other animals before testing it in humans. And, of course, experience with the HPV vaccine shows that there’s work to be done to make sure people get vaccines that prevent STIs even after they’re invented. Nonetheless, a vaccine to prevent chlamydia would be a great victory in our ongoing fight against STIs and their health consequences, and we here at This Week in Sex are happy to end on a bit of a positive note.

Commentary Sexual Health

Fewer Teens Are Having Sex, But Don’t Pop the Champagne Yet

Martha Kempner

The number of teens having sex may be less important than the number having protected sex. And according to recent data from the Centers for Disease Control and Prevention, condom use is dropping among young people.

Every two years, the Centers for Disease Control and Prevention’s Division of Adolescent and School Health (CDC-DASH) surveys high school students to gauge how often they engage in perceived risky behaviors. The national Youth Risk Behavior Surveillance (YRBS) is wide ranging: It asks about violence, guns, alcohol, drugs, seat belts, bicycle safety, and nutrition. It also asks questions about “sexual intercourse” (which it doesn’t define as a specific act) and sexual behaviors.

Started in 1991, this long-running study can provide both a picture of what high school students are doing right now and a historical perspective of how things have changed. But for more than a decade, the story it has told about sexual risk has been the virtually the same. Risk behaviors continually declined between 1991 and 2001, with fewer high school students having sex and more of them using condoms and contraception. But after the first 10 years, there has been little change in youth sexual risk behaviors. And, with each new release of almost unchanging data, I’ve reminded us that no news isn’t necessarily good news.

This year, there is news and it looks good—at least on the surface. The survey showed some significant changes between 2013 and 2015; fewer kids have ever had sex, are currently sexually active, or became sexually active at a young age. More teens are relying on IUDs and implants, which are virtually error-proof in preventing pregnancy.

In 2015, 41 percent of high school students reported ever having had sexual intercourse compared to 47 percent in 2013. The researchers say this is a statistically significant decrease, which adds to the decreases seen since 1991, when 54 percent of teens reported ever having had sexual intercourse.

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Another change is in the percentage of students who had sex for the first time before age 13. In 2015, 4 percent of high school students reported this compared to almost 6 percent in 2013. This is down from a full 10 percent in 1991. As for number of overall partners, that is down as well, with only 12 percent of students reporting four or more partners during their lifetime compared to 15 percent in 2013 and 19 percent in 1991. Finally, the percentage of students who are currently sexually active also decreased significantly between 2013 (34 percent) and 2015 (30 percent).

These are all positive developments. Delaying sex can often help prevent (at least temporarily) the risk of pregnancy or STIs. Having fewer partners, especially fewer concurrent partners, is frequently important for reducing STI risk. And those teens who are not currently having sex are not currently at risk for those things.

While I want to congratulate all teens who took fewer risks this year, I’m not ready to celebrate those statistics alone—because the number of teens having sex is less important to me than the percentage of teens having sex that is protected from both pregnancy and sexually transmitted infections. And that number is lower than it once was.

Among sexually active teens, there were no significant positive changes in measures of safer sex other than an increase in the number of sexually active high school students using the IUD or implant (up to 4 percent from 2 percent in 2013).

Moreover, some results indicate that today’s teens are using less protection than those who were teens a decade ago. The most telling finding might be the percentage of teens who used no method of contraception the last time they had sex. This decreased between 1991 and 2007 (from 17 percent to 12 percent), inched up to 14 percent in 2013, and stayed the same in 2015 (14 percent). There was also little to no change in the percentage of high school students who say that either they or their partner used birth control pills between 2013 (19 percent) and 2015 (18 percent) or those who say they used the contraceptive shot, patch, or ring (5 percent in 2013 and 2015).

For me, however, the most distressing finding is the backward progress we continue to see in condom use. The prevalence of high school students who used a condom at last sex went up from 45 percent in 1991 to 63 percent in 2003. But then it started to drop. In 2015, only 57 percent of sexually active high school students used condoms the last time they had sex, less than in 2013, when 59 percent said they used condoms.

It’s not surprising that teens use condoms less frequently than they did a decade ago. In the 1990s, the HIV epidemic was still front and center, and condoms were heavily promoted as a way to avoid infection. As this threat waned—thanks to treatment advances that now also serve as prevention—discussions of the importance of condoms diminished as well. The rise of abstinence-only-until-marriage programs may have also affected condom use, because these programs often include misinformation suggesting condoms are unreliable at best.

Unfortunately, some of the negative messages about condoms inadvertently came from public health experts themselves, whether they were promoting emergency contraception with ads that said “oops, the condom broke”; encouraging the development of new condoms with articles suggesting that current condoms are no fun; or focusing on teen pregnancy and the use of highly effective contraceptive methods such as long-acting reversible contraceptives (LARC). The end result is that condoms have been undersold to today’s teenagers.

We have to turn these condom trends around, because despite the decreases in sexual activity, young people continue to contract STIs at an alarming rate. In 2014, for example, there were nearly 950,000 reported cases of chlamydia among young people ages 15 to 24. In fact, young people in this age group represented 66 percent of all reported chlamydia cases. Similarly, in 2014, young women ages 15 to 19 had the second-highest rate of gonorrhea infection of any age group (400 cases per 100,000 women in the age group), exceeded only by those 20 to 24 (489 cases per 100,000 women).

While we can be pleased that fewer young people are having sex right now, we can’t fool ourselves into believing that this is enough or that our prevention messages are truly working. We should certainly praise teens for taking fewer risks and use this survey as a reminder that teens can and do make good decisions. But while we’re shaking a young person’s hand, we should be slipping a condom into it. Because someday soon (before high school ends, for more than half of them), that teenager will have sex—and when they do, they need to protect themselves from both pregnancy and STIs.