Last Friday, the FDA approved the Gardasil vaccine for use in boys and men ages 9 to 26 years old. When I heard this news, I was surprised. My daughter received the vaccine from her physician, and I had always thought of this as a "cervical cancer vaccine." The reality, however, is that this is a HPV vaccine, to guard against the sexually transmitted Human Papillomavirus. Why, however, is it only now being approved for males, when it was approved three years ago for females?
I turned to Adina Nack, Ph.D., professor of medical sociology and sexuality studies at California Lutheran University, for answers. She is the author of the book Damaged Goods? Women Living with Incurable Sexually Transmitted Diseases (Temple Univ. Press, 2008), and her research on STI stigma provides insight into the negative health consequences of Merck's original campaign for developing and marketing a female-only Gardasil. In my email interview with her, she reflects on the recent news.
Why do you think Merck first sought FDA approval of Gardasil only for women?
Only going through the FDA testing and approval process for women allowed Merck to brand Gardasil as a 'cervical cancer' vaccine. Prior to the recent FDA approval of Gardasil for use on male patients, most Gardasil ads have claimed to empower girls and young women with a new tool to protect against cervical cancer. But, it is not clear how many Americans have understood that they were being sold a vaccine designed to protect against a STI.
In your book and blog posts, you talk about the stigma connected with sexually transmitted infections (STIs) being gender-based. How are attitudes about STIs reflected in the initial branding and marketing of Gardasil as a cervical cancer vaccine?
As early as 2005, some organizations have been outing Gardasil as a STI vaccine and arguing that inoculating young adolescents against HPV would encourage teenage sexual promiscuity. The heads of various "family values" groups publicly declared that they would not vaccinate their own children. So, some have questioned whether Merck's decisions to only seek initial FDA approval for female use and to brand it a 'cervical cancer' vaccine may have been motivated by a desire to distance the vaccine (and those who receive it) from the negative stereotypes we have about STIs and the types of people who contract them. On one hand, it is reasonable to assume that most U.S. parents would not be eager to have their daughters, as young as 9 years old, vaccinated against 4 strains of a virus that is primarily transmitted by sexual contact. After all, studies have shown that we're more likely to assign negative traits - like promiscuity, irresponsibility, naivety, and unintelligence - to girls and women who contract STIs than to boys and men who contract the same infections. The Council on Contemporary Families has a forthcoming study showing that, while equality has increased in many areas, sexual-behavior double standards persist. In the U.S. and many other countries, a female patient who seeks out a STI vaccine often has reason to worry that others will label her a 'bad girl' or 'fallen woman.' We are more likely to see a 'cervical cancer' vaccine as something that good girls and chaste women are justified in seeking out.
If this strategy might have increased the numbers of girls/women receiving the vaccine, then what is the problem?
It can be argued that the success of branding Gardasil as a cervical cancer vaccine has come with serious public health costs. How can we account for the boys and men who have been unable to legally access this for the last 3 years, a time period in which many of them (and their sexual partners) could have been protected against HPV-related diseases and cancers? Prevention and early detection is especially important for HPV infections because we do not yet have a true 'HPV test' or medical cure. By not seeking FDA approval for both male and female patients at the same time, this vaccine's potential benefit to the public was limited. The FDA's recent decision to approve male Gardasil has confirmed that Merck sold us a STI vaccine disguised as a cancer vaccine. Despite the messages in Merck's successful female Gardasil campaign, cervical cancer has never been the only reason to care about the HPV pandemic: medical studies have connected HPV to oral cancers and anogenital cancers in both female and male patients.
You have made the point that the Gardasil ad campaign was a primary source of HPV information for many who had not previously been educated about this STI - what do you see as the downsides to this?
By obscuring the fact that HPV is a STI in its marketing of Gardasil, Merck missed a chance to educate us about this highly contagious family of viruses: one can contract HPV from the types of skin-to-skin contact that can take place even when sexual partners are using barrier methods, like condoms or dental dams. Given the current trends in U.S. teen sexual attitudes and behaviors, I'm also concerned about how many young people are at risk for contracting HPV because they are engaging in oral sex or anal sex to remain a 'virgin.'
There has yet to be a large-scale public health campaign to educate the U.S. public about the truth of HPV, so Merck's Gardasil marketing materials may have been the first (and sometimes only) 'education' about HPV for many Americans. For teens and young adults whose primary source of HPV information came from Gardasil ads, then what is the public health damage of not clearly understanding that HPV is sexually transmitted? What about not realizing that HPV can infect and have serious health consequences for boys/men?
Why do you see de-stigmatizing STIs as key to improving sexual health in the U.S.?
With Gardasil now fully unmasked as the HPV vaccine it has always been, I'm hopeful that we will stop believing the myths that HPV is only a concern for females and that only promiscuous people get STIs. The availability of safe and effective STI vaccines is something to celebrate. Gardasil's new approval for use by boys/men is an important opportunity to destroy longstanding myths. To de-stigmatize HPV is to stop viewing it - or any other STI - as a sign of immorality. Through my website, I receive emails every week from those whose genital HPV and herpes infections have damaged not only their health but also their self esteem, their relationships, and their social reputations. Eliminating the shameful stigma of STIs could free millions of infected women and men from social and psychological traumas and harm public health. Viewing these kinds of infections as medical conditions would allow STI patients to focus on pursuing treatment options that not only allow them to manage their own symptoms but also make them less likely to infect others. Destigmatizing STIs may also increase the odds that a newly diagnosed person will disclose their sexual health status to their sexual partner. New social attitudes and better public health education about STIs can prepare Americans to support future STI/HIV vaccination programs.
As a result of marketing Gardasil as a cervical cancer drug for girls and women only, scores of males and their partners have unnecessarily contracted HPV over the past three years; the full range of health consequences of HPV have been ignored, and stereotypes and stigmas around STIs remain entrenched. Astoundingly, the American Social Health Association reports that "about 5.5 million new genital HPV cases occur each year -- this is about 1/3 of all new STD infections." Clearly, what we need is open and honest education about HPV and other STIs. We have allowed our stereotypes about women's sexuality and STIs to put our public health at greater risk.