Gardasil

Having written about sexually transmitted HPV (human papillomavirus) for 13 years, I’ve been waiting for the day when  celebrity would lend his or her fame to spotlight the realities of HPV infection, especially of HPV-related oral cancers. My hopes were that big news could bring about big change.  Today is that day, but it remains to be seen if it can be long-needed catalyst for change.

File:Michael Douglas VF 2012 Shankbone.JPGWhen news first broke, about three years ago, that Michael Douglas had oral cancer, my gut instinct was that it had been caused by HPV, likely one of the same types of HPV that has been causally linked to cervical cancer. The mucus membrane tissue of mouth and throat are similar to those of genital skin, so researchers have known for some time that, like herpes, HPV could be transmitted oral to genital, as well as genital to oral.

Back in 2009, the research findings were already clear: oral transmission of cancer-causing HPV means that almost all of us are more likely at risk than we are safe from risk.  For my 2010 feature article in Ms. Magazine, I focused on the importance of not only educating the public about HPV-related cancers in men but also about the HPV-oral cancer link. In addition, I advocated for the need to destigmatize all STDs: my research and book have shown that STD stigma makes it more likely for at-risk/infected  individuals to put off getting tested and treated. STD stigma also makes it less likely for individuals to disclose their sexual health status to partners, placing those partners at greater risk for infection.  In addition, negative stereotypes about the ‘types’ of women and men likely to be infected distort our ideas of who is at risk.

I’ll wrap up this post with a call: for us to come together, to learn the facts and not be swayed by incomplete media coverage and confusing pharmaceutical claims.  We must support significant funding increases to investigate exactly how we can prevent HPV-related oral/throat cancers, which research shows to be steadily on the rise and more fatal than cervical cancers in the U.S.

Update (6/3/13): I was not surprised to read reports which broke today — that the actor’s rep is correcting one aspect of yesterday’s breaking news: “He did not say cunnilingus was the cause of his cancer.” All any cancer survivor probably knows is that his/her cancer was caused by HPV (viral tests and typing can be done in lab tests of biopsied tissue samples). Researchers have found that cancer-causing HPV can be transmitted to oral/throat area via oral sex. The point remains: Michael Douglas did a good deed by helping raise awareness that serious (often fatal) oral cancers can be caused by sexually-transmitted HPV which is likely contracted by oral sex….

As a sexual health researcher, I have followed the saga of HPV (human papillomavirus) vaccination since the early 2000s. I’m posting this month’s column early to address three news stories that recently caught my attention – both for what they reported and also for what they left out:

File:Gardasil vaccine and box new.jpg

March 26, 2012: PRNewswire report on Harold zur Hausen’s remarks at the annual meeting of the Society of Gynecologic Oncology. Having won the 2008 Nobel Prize in Medicine for discovering the link between HPV and cervical cancer, zur Hausen kept the spotlight on cervical cancer when he advocated for HPV vaccination of young females and males in order to “eradicate cervical cancer.” While I advocated for non-sexist HPV vaccination policies back in a 2010 Ms. Magazine article, I was surprised by reports that zur Hausen favored male vaccination: “…if society were to vaccinate just one gender to prevent the spread of cervical-cancer causing HPV, it would be more effective to vaccinate just males.”  I found myself asking two questions: (1) Why base medical recommendations on heterosexist assumptions that girls/women only contract cancer-causing strains of HPV from male partners? (2) Why continue to narrowly focus on HPV as a cause of cervical cancer, when a growing body of research documents its role in a range of genital cancers as well as often fatal oral-throat cancers?

April 2, 2012: The New York Times offers a summary of a study published in the March issue of the British Medical Journal: the findings suggest that HPV vaccination “can significantly cut the likelihood of virus-related disease even among women who have had surgery for cervical cancer caused by HPV.” The strongest prevention effect – 64% reduction in risk – was for women who had the most serious kinds of cervical cancer. The article quotes Dr. Elmar A. Joura, associate professor of gynecology at the Medical University of Vienna: “Regardless of your age or your history, a vaccination can prevent new disease.” Key question not addressed by this article: why does the CDC have an upper-age limit of 26 years old for HPV vaccination? Last year, Canada raised their upper-age limit to 45 – how much longer will ‘older’ Americans have to wait?

April 4, 2012: Forbes article on “The Gardasil Problem” fails to address the full scope of HPV vaccination ‘problems.’ First, the author misleads readers into thinking that HPV-related oral-throat cancers are “a new form” – again, see not only the 2010 Ms. Magazine article but also the Oral Cancer Foundation’s thorough summary of the decades of research linking sexually-transmitted HPV to serious oral cancers.

The author also misstates the focus/bias of Merck’s original years of marketing Gardasil: “When it was introduced in 2006…Merck began an advertising push to raise awareness of the risks of HPV.” What ads did he see? I and other consumers of mainstream media were exposed to a series of commercials that referred to Gardasil as “the cervical cancer vaccine” and strategically obscured message about “HPV-related diseases”, never clarifying for viewers that HPV was, in fact, sexually transmitted.  While I offered a feminist critique of the branding and marketing of Gardasil in my 2008 book and several blog posts – trying to get the public to understand that “You don’t need to have a cervix to benefit from the cervical cancer vaccine” – Merck did not change to a focus on Gardasil as a STD vaccine until it received FDA approval for male vaccination…until profits depended upon bursting the bubble of the mythical cervical cancer vaccine.

Next, the author not only makes a heterosexist assumption but also unnecessarily demonizes oral sex on women as the ‘usual’ mode of transmission: “Usually transmitted when men perform oral sex on women, it can also spread through other forms of contact, perhaps even just kissing.”  If kissing can transmit the virus, the why is he so sure that most of men with HPV-related oral-throat cancers skipped ‘first base’ and went straight to ‘third base’? If, and this is a big ‘if’, clinical studies can verify unprotected oral sex as the primary mode of transmission, then why not offer readers a brief education on the vaccine-free ways to practice safer oral sex

Finally, the author unnecessarily dashes readers’ hopes for the near future: “tests that might well prove that [Gardasil] can prevent the new throat cancer strain would take at least 20 years, until the boys sampled actually became sexually active and then contracted the disease.” Why would these tests take 20 years? Does this author think that a boy who is vaccinated at age 12 will not perform oral sex until he’s 20+ years old? Where is the data to show it would take another ten years for HPV-related oral and throat cancers to develop?  In addition, the author fails to point readers towards the likely source of delay: a lack of interest by the makers of the two FDA-approved HPV vaccines.   

A 2010 article in the Journal of the National Cancer Institute not only clarifies the challenges of developing effective screening for oral HPV infections but also reports the truth about Merck’s failure to move forward with testing HPV vaccination as prevention of oral and throat cancers. Maura Gillison, M.D., Ph.D., a leading researcher on HPV-related head and neck cancers at Ohio State University in Columbus, explained why clinical trial plans were derailed in 2010: “We were 6 weeks from enrolling the first patient when I got an e-mail saying it was no longer in the interest of Merck to conduct the trial.” The article also quotes Pam Eisele, a Merck spokeswoman:

“The link between HPV infection and head and neck cancers continues to be an area of scientific interest for Merck; however, we currently do not have any plans to study the potential of Gardasil to prevent HPV-related oropharyngeal cancers. In 2008, we did conduct a small pilot study to assess our ability to obtain adequate and valid oropharyngeal samples. While the results of the pilot study were promising, due to competing research and business priorities we ultimately decided not to move ahead with an efficacy study at this time.”

Why is Forbes not asking for a more complete explanation of those “competing research and business priorities”?  We, the American public, should demand more funding find out how to prevent cancers which research shows to be on the rise and more fatal than cervical cancer in the U.S.

The one section of this Forbes article that some readers might find valuable is its summary of the data on the safety record of HPV vaccination.  However, as I’ve said before, I am not advocating that vaccination is the only way to reduce one’s risk of contracting cancer-causing strains of HPV.  Those who decide not to vaccinate themselves and/or their children need to learn the facts about HPV prevention, testing, diagnosis, and treatment: check out the American Social Health Association’s online HPV and Cervical Cancer Prevention Resource Center.

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.

Last week, the NYT reported “Merck: Studies Boost Gardasil for New Uses“; this week the CDC’s Advisory Committee on Immunization Practices (ACIP) met to discuss these new results. It will be interesting to see what, if any, changes result from new clinical evidence that (1) the vaccine is effective in preventing anal precancers in males and (2) the vaccine is effective in women 27-45 years old.

Those who’ve followed HPV research for the past decade were not surprised by the findings of either study. What has surprised me is how little attention ‘male’ Gardasil has attracted since receiving FDA approval last October. Writing a feature article for the Winter 2010 Ms. magazine gave me the opportunity to more deeply explore this topic and hopefully raise awareness — not only about Gardasil, a.k.a. the “cervical cancer” vaccine, but also about the full range of male HPV-related cancers that it might also prevent. 

So, this month’s column is inspired by my desire to respond to some of the interesting questions, comments and accusations that I’ve received via the blogosphere (like WashingtonCityPaper and HugoSchwyzer) in these first days following the publication of my article. I’ll start by acknowledging that my article’s title seems to have pushed more than a few buttons: apparently not everyone wants to know “Why Men’s Health is a Feminist Issue.” One comment asked “Why does the burden for sexual health need to fall, yet again, to women?” My response: It’s a burden for only girls/women to be responsible for sexual health, so prioritizing equal access to STI/STD vaccines results in a more fair sharing of this ‘burden.’ From the opposite side, a comment criticized this angle as being self-interested: “…when feminists speak of male health issues, it is usually in the context of the way they affect women.” To that, I reply: if you read the full article, you’ll see that boys/men have plenty of reasons to care about having access to this vaccine that have to do with protecting their own health, regardless of whether or not they ever have a female sexual partner.

This leads to another trend in responses: What’s in it for men?  Or, as one comment put it, “The only reason for males to get the vaccine would be to prevent HPV in women.” Really? How about the variety of serious HPV-related male cancers (oral, penile, anal, and others) that are (1) on the rise, (2) often fatal due to lack of accurate testing/screening, and (3) in the U.S. likely result in more combined deaths in men than cervical cancers in women? (See my Ms. article for an overview of these stat’s or, if you love charts check out p. 4 of the American Cancer Society’s 2009 report).

And, media coverage of Gardasil would not be complete without questions/concerns focused on whether or not Gardasil does more harm than good. For the record: I have not taken a pro-vaccine or anti-vaccine stance on Gardasil or any other vaccine. But, I speak in favor of equal access to vaccines, support the conducting and media coverage of medical studies that reveal the full range of potential health costs and health benefits of any vaccine,  and argue for funding public health campaigns about HPV and other sexually transmitted epidemics. And, though some blog comments reveal confusion over the possibility of being “required” to get the Gardasil vaccine, I’m not aware of any current U.S. vaccination policy that does not allow for ‘opting out.’ (Note: as of December 14, 2009 Gardasil was no longer required for female green card applicants.)

A less popular theme, though one that intrigues me, came from those who took the angle of “What’s in it for big pharma?” One comment hypothesized, “…you can’t help but suspect Merck’s money motive is playing a role in the push for expansion to men.”  And, I reply, what PUSH? If money was their motive, then wouldn’t they have updated the Gardasil.com website to encourage male consumers? Visit that site prior to March 1, and you’d think that it was still only approved for girls/women.

I’ll end this post by expressing my thanks to all of the journalists and blog authors who are raising awareness about this topic, including Ms.‘s own Executive Editor Katherine Spillar on the Huffington Post. I also send out my gratitude to blog readers who add insightful, thoughtful, sociological, and truly feminist comments like Annie‘s. In my opinion, to be feminist is not to be pro-women, it is to be pro-equality and pro-justice (not to mention anti-sexism, anti-racism, anti-homophobia, anti-ageism…you get my drift). 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.