Merck

In honor of April being STD Awareness Month, I devote this month’s column to a topic that remains near and dear to my heart (and my cervix): HPV, human papillomavirus.  So, it’s a great time to get yourself tested at your local STD testing location, or send an e-card to a loved one who could use a friendly reminder:

Don't just wait and seeSTDs often have no signs or symptomsThis month might have inspired some of you to consider vaccines that offer some protection against HPV: like Gardasil or Cervarix.*  However, don’t get too excited about Gardasil if you happen to be 27 years old (or older) and live in the U.S.  Earlier this month, the FDA decided against expanded the vaccine’s label use for ‘older’ women:

…the Limitations of Use and Effectiveness for GARDASIL was updated to state that GARDASIL has not been demonstrated to prevent HPV-related CIN 2/3 or worse in women older than 26 years of age.

However, as of Tuesday, ‘older’ Canadian women now have more options than their U.S. counterparts:

Merck announced that Health Canada has extended the indication of GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Recombinant Vaccine] in women up to the age of 45. Merck’s HPV vaccine is now approved for girls and women nine through 45 years of age for the prevention of cervical cancer, vulvar and vaginal cancers, precancerous lesions and genital warts caused by the Human Papillomavirus (HPV) types 6, 11, 16, 18.

So, what’s the deal?  According to a Canadian women’s health expert, this is a good decision:

Whatever the reason, there’s a tendency for women to remain at risk of acquiring new HPV infections as they get older. Whether they are changing their social status or not, women should talk to their doctors about the HPV protection provided by the quadrivalent vaccine,” said Dr. Alex Ferenczy, Professor of Pathology and Obstetrics & Gynecology at McGill University.

If I’m correct in inferring that Dr. Ferenczy’s use of the phrase “social status” refers to a woman’s sexual partner/sexual relationship status, then are we to assume that U.S. women between the ages of 27 and 45 are in more stable sexual relationships than their Canadian counterparts?  I’ve yet to read a study that would support this conclusion.

So, as a U.S. woman who happens to be in this age group, I feel it only right to encourage my peers to ask their doctor about Gardasil, especially if they’re “changing their social status.”

For the boys and men out there, remember that the FDA approved Gardasil in October 2009 for protection against two types of HPV which cause genital warts in males ages 9-26.  Then, last December, the FDA approved of GARDASIL for the prevention of anal cancers caused by two different types of HPV in females and males 9-26 years old. 

However, once again, there appears to be possible age-discrimination: men over 26 years old, consider whether Gardasil might offer health benefits for you.

*Note to readers: I respect that many will decide that a vaccine is not right/healthy/safe for themselves or for their family members.  I highlighted the recent news about Gardasil because I believe that everyone deserves access to vaccine updates.  I’ll conclude by quoting myself:

I don’t know if the pro- and anti-vaccine folks will ever see eye to eye, but there’s absolutely nothing to lose and everything to gain by being pro-HPV-education.

Some would say this has been true since 2006, when the FDA approved Gardasil for exclusive use in girls/women, and finally the FDA agrees. Last week Merck received FDA approval for Gardasil to be used as a genital warts vaccine in boys/men (ages 9 to 26 years old). However, yesterday, the CDC Advisory Committee on Immunization Practices voted for only “permisive” use in boys, rather than voting for the stronger recommendation of “routine use,” as they had for Gardasil’s use in girls/women.

As reported in Bloomberg.com, this decision had been predicted by some experts:

William Schaffner, chairman of the department of preventive medicine at Vanderbilt University in Nashville, Tennessee, said the panel will be asking itself “if we vaccinate all the girls, how much additional benefit will we get by vaccinating the boys?”

The Atlanta Journal-Constitution cited a similar argument from a different expert:

Debbie Saslow, director of breast and gynecologic cancer at the American Cancer Society, agreed with the findings. “If we can vaccinate a high enough proportion of young girls, then vaccinating boys is not cost-effective,” she said.

This line of reasoning and the ACIP’s conclusion are problematic on two levels. First, there seems to be a privileging of female health over male health. There are compelling reasons “ other than the prevention of cervical cancer” for the ACIP to recommend “routine use” of a safe and effective male HPV vaccine. Second, there seems to be a heterosexist assumption in the ACIP’s decisions — that all boys/men are sexually attracted to (and sexually active with) girls/women and vice versa.

Maggie Fox of Reuters offered a more complete assessment in her article published yesterday:

The main reason the vaccine was approved was to prevent cervical cancer, which kills 4,000 women a year in the United States alone. But various strains of HPV also cause disfiguring genital warts, anal and penile cancers and head and neck cancers. “We know that the later the cancer is discovered, the lower the chance of survival is,” David Hastings of the Oral Cancer Foundation told the committee, asking for a recommendation to add the vaccine to the standard schedule for boys. However, ACIP decided only to consider its use based on its ability to prevent genital warts.

Did the ACIP adequately factor in the clinically proven causal links between certain strains of HPV and potentially life-threatening oral cancers — which do not discriminate on the basis of sex? This seems important, particularly if, “The death rate for oral cancer is higher than that of cancers which we hear about routinely such as cervical cancer” (Oral Cancer Facts)?

A recent New York Times article reports that the committee will “take up the issue of the vaccine’s effectiveness in preventing HPV-related male cancers at its next session in February, when more data should be available.”  But data has been available since 2007, when results of clinical studies were reported and the Oral Cancer Foundation issued a press release urging male HPV vaccination?

If the FDA believes Gardasil is safe and effective, then we deserve a more thorough explanation of why the vaccine’s potential to protect against oral cancers — in both men and women — is not reason enough for the federal advisory group to issue as strong a recommendation for male vaccination as for female vaccination.


Here today is Adina Nack with a fantastic guest post on how STD stereotypes have led to the mismarketing of the HPV vaccine as a cervical cancer vaccine. An associate professor of sociology, who has directed California Lutheran University’s Center for Equality and Justice and their Gender and Women’s Studies Program, and author of Damaged Goods?, Adina asks some provocative questions about the consequences this gendered mislabeling will have for public health awareness. –Kristen

The “Cervical Cancer” Vaccine, STD Stigma & the Truth about HPVby Adina Nack

You’ve probably seen one of Merck‘s ads which promote GARDASIL as the first cervical cancer vaccine. Last year, their commercials featured teenage girls telling us they want to be “one less” woman with cervical cancer. GARDASIL’s website features new TV spots which say the vaccine helps prevent “other HPV diseases,” too, and end with, “You have the power to choose,” but do you, the viewer, know what you are choosing?

 

A clue that this is a STD vaccine appears briefly at the bottom of the screen: “HPV is Human Papillomavirus.” Merck’s goal may have been to appeal to parents who are squeamish about vaccinating their daughters against 4 types of virus which are almost always sexually transmitted. This marketing strategy means that the U.S. public, currently undereducated about HPV, is none the wiser about this family of viruses which infect millions in the U.S. and worldwide each year. When the ads briefly mention “other HPV diseases,” how many realize they’re talking about genital/anal warts and that recent studies link HPV with oral/throat cancers? [You don’t need to have a cervix (or even a vagina) to contract any of these “other” HPV diseases.] Why don’t they want us to know the whole truth about the vaccine?

Branding GARDASIL as a cervical cancer vaccine was aimed at winning public support. But, what are the consequences of a campaign built on half-truths? Today, only females, ages 9-26, can be protected against strains of a virus that may have serious consequences for boys/men and women past their mid-20s. If public health is the goal, then let’s question how our STD attitudes shaped a marketing plan which has, in turn, influenced drug policy.

Marketing a “cervical cancer” vaccine may have appeased some social conservatives who don’t want their daughters vaccinated against any STD, fearing it might promote premarital sex. But, the vaccine will likely soon be available to males, and their anatomy does not include a cervix — will girls get a “cervical cancer” vaccine and boys get a HPV vaccine? The current gender-biased policy supports a centuries old double-standard of sexual morality. Most view STD infections as more damaging to women than to men. Many believe that STDs result from promiscuity — girls/women deserve what they get. So, are we ready to embrace any STD vaccine (including a future HIV vaccine) as a preventive health measure?

Having studied women with HPV, I know that a person can contract the virus from nonconsensual sex or from their first sexual partner — you could still be a ‘technical’ virgin since skin-to-skin contact, not penetration, is the route of transmission. In my new book, Damaged Goods?, I take readers inside the lives of 43 women who have struggled to negotiate the stigma of having a chronic STD. One chapter delves into stereotypes about the types of people who get STDs: these beliefs not only skew our perceptions of STD risk (bad things only happen to bad people) but also can psychologically scar us if we contract one of those diseases. Merck’s branding of GARDASIL makes sense: a typical U.S. teenage girl or young woman has good reason to fear others’ judgments of her — thinking her to be promiscuous, dirty, naïve, and irresponsible — if they knew she’d sought out a STD vaccine. Whereas, getting a “cervical cancer” vaccine feels more like something that a responsible girl/woman would do.

Unfortunately, with GARDASIL taking the easy way out, the U.S. public misses a prime opportunity to learn about this prevalent, easily transmitted disease that is unfortunately difficult to test for. We’ve also lost a chance to take on STD stigma and challenge the population to view sexually transmitted infections as medical problems rather than as blemishes of moral character.

No vaccine is 100% effective and neither are the treatment options for HPV infections. STD stereotypes (particularly negative about infected women) come back to haunt those of us who become infected with diseases like HPV and herpes, which are treatable but not curable. Until there’s a ‘magic bullet’ cure, we should educate ourselves not only about medical facts but also about STD stigma — the anxiety, fear, shame and guilt — that often proves more damaging to the lives of those infected than the viruses, themselves.