Over the last several years, human papillomavirus (HPV), one of the most common sexually transmitted infections in the United States, has gone from relative obscurity to a source of heated debate and, for some, a new cause for fear. Casting a new spin on an old infection, Merck Pharmaceuticals single-handedly produced more widespread familiarity with the virus and manufactured the catalyst for conversations about HPV and cervical cancer. In June 2006, Merck received FDA approval for a new vaccine that protects against four of the more than thirty types of sexually transmitted HPV, Gardasil. Even before its approval, Merck advertised the coming vaccine indirectly with the teaser “Tell Someone.” In doing so, Merck began the process of using marketing to position a vaccine that protects primarily against a common sexually transmitted infection instead as a powerful vaccine against cancer.
The HPV vaccine debuted on the market with an advertisement campaign explicitly acknowledging women’s lack of familiarity with the virus and its consequences. The television ads featured women talking directly to the camera, exclaiming, “Cancer caused by a virus…I didn’t know that!”
As the “Tell someone” campaign encouraged its viewers, sharing this knowledge with other women was critical. Concurrent with its direct-to-consumer advertising, Merck also launched an “Educate the educators” session to inform physicians about the new vaccine, anticipating a fair amount of public resistance to vaccinating girls (ages 9-26) with a vaccine that might minimize the consequences of sexual activity. The importance of this education also stemmed from the fact that HPV is not well understood even among many physicians, likely as a result of the many types of HPV that exist. In a physician education session targeting gynecologists that I attended, the majority of the session focused on the epidemiology of the virus, and session leaders failed to discuss any of the existing treatment options, which most attendees would be using in their everyday practice. In other words, Merck seemed to expect that even physicians had vague knowledge about one of the most common STIs.
At its FDA hearing, Merck explicitly focused on the vaccine as a response to a variety of working groups that sought to reduce mortality due to cervical cancer. The promotion of the vaccine and the management of the trial data stressed that the “need” was for a cancer vaccine, not for a vaccine to prevent a highly transmissible and very prevalent STI. Some of this focus may reflect the company’s desire to minimize parental resistance to the vaccine. In the months leading up to the vaccine’s distribution, a variety of popular press articles questioned whether a vaccine for an STI could really gain acceptance in the United States, with its recent history of abstinence only programs in lieu of sexual health education. The reactions from a number of conservative family organizations, like Focus on the Family, and these groups’ public acceptance of the vaccine also suggest that Merck packaged its campaign to address their concerns. Once the FDA approved the vaccine, these groups acknowledged that they were not against a vaccine that protected against cancer, but they were against government requirements of the vaccine. This carefully worded response played into Merck’s own positioning perfectly. While the vaccine does prevent the infection with some types of HPV that can cause cancer, cancer is not, in fact, an inevitable outcome of an HPV infection. This point, though small, is rather critical. Merck’s entire advertising campaign has focused on HPV’s cancer potential; a recent advertisement that leads the viewer to visit Merck-owned HPV.com portrayed a young woman’s (heteronormative) life dreams (college, travel, boyfriend, marriage) as pre-empted by her health decline into a cancer that could be prevented. HPV.com directs the viewer to learn more about preventing the STI by sending her to the Gardasil website. The tagline for this promotion is quite simple: HPV. Why risk it?
Once Merck received its FDA approval, the campaign progressed from the vague and non-specific “Tell Someone,” into “One Less” (woman/girl with cervical cancer) and then to “I Chose.”
In addition to its advertisements, Merck created a program initially called “Make the Connection,” which was renamed “Make the Commitment,” that offered make your own bracelet kits for free that would donate money to a cancer research organization. A number of celebrities participated in the purported “public service announcement” promotions, which have since been discontinued.
The Gardasil campaign, which included non-transparent lobbying of state legislatures to require the vaccine for school-entry, revealed that the pharmaceutical company’s message and the everyday experience of/practice around HPV infection were not completely coherent with each other. Merck’s education campaign pushed the vaccine as an unquestionable necessity, neglecting to mention how highly effective other technologies of gynecological care can be to reduce cervical cancer. The Pap smear, for example, has been used in the U.S. since the 1940s, and while it is an imperfect science, its institutionalization through gynecological guidelines have reduced American women’s deaths from cervical cancer to about 3,400 a year from more than 70,000 annually in the 1970s. Still, the consequences of HPV morbidity are not insignificant and reducing the spread of the disease is not inconsequential. What causes concern, however, is Merck’s positioning of Gardasil as a cervical cancer vaccine (not an STI vaccine), which in fact complicates how women may understand the benefits and limitations of the vaccine. What remains problematic about Merck’s campaign is that even with the HPV vaccine, women will need to have the same gynecological screening and treatment that women experienced before the vaccine. Women’s experiences with gynecological care may not change radically.
Merck’s vaccine (and now GlaxoSmithKline’s recently approved vaccine) is not intrinsically bad; such a position is uncomplicated and fails to take into account the fact that HPV can be a serious infection, regardless of whether it develops into cancer or not. However, the company’s willingness to use fear to incite parents and young women to vaccinate casts doubt on the insistent message that the vaccine will liberate women from traumatic health care experiences. Gynecological care is not without its limitations. Technicians read hundreds and hundreds of Pap smear slides in a day. Human errors can contribute to the progression of HPV to cervical cancer, and clinicians’ and patients’ continued uncertainty about the most appropriate interventions and even prevention make the vaccine a very powerful prophylactic.
Merck invested a lot of time and money in “educating” people — public health officials and providers in particular — about HPV and cervical cancer as the vaccine became available and widely disseminated. Tracking exactly how and where the money has gone is difficult because, like the program for Make the Connection/Commitment, Merck’s strategies appear to have included supporting a number of non-profits, such as Women in Government, an organization that lobbied in various states for the vaccine requirements in schools. But all its investment in education stressed the necessity of the vaccine, rather than focusing on preventive health as a more comprehensive strategy. Because a more comprehensive cervical health education focus might obviate the urgency of the vaccine, the emphasis in all the educational materials was on the ubiquity of HPV and the challenges of preventing its spread.
Throughout Merck’s HPV and Gardasil advertisements, little has been said about the treatability of cervical cancer or the success at preventing HPV from progressing to cancer. Much like other pharmaceutical interventions designed to make life easier, when available solutions exist to address the same problem, Gardasil offered an alternative but is not a panacea. Many of the screening techniques and preventive health services are less expensive (per use) than the high cost (and incomplete levels of protection) that the vaccine presents. Though Merck has set up programs to allow low-income women (and presumably now men, since its FDA approval in boys and men in September 2009) to receive financial assistance to get the vaccine, Gardasil debuted on the market as the most expensive vaccine. Costing nearly $350 for the three shot series, the vaccine initially was a big money maker for Merck with $1.4 billion sales worldwide in 2007. Its first quarter report in 2010, however, showed an 11% decrease in sales from the same time last year. Sales of the vaccine, however, are harder to track than other treatments, because governments fuel much of the purchasing, with programs like the United States’ Vaccines for Children program and county public health programs’ acquisition of the vaccine. Current research suggests that there are still significant disparities between women/girls who receive the vaccine and those who don’t. Much like the disparities in cervical cancer rates (and deaths), class and race seem to be the distinguishing factors in terms of who gets the vaccine. With further approval to market the vaccine to older women, Merck is capturing a large market share of people who may not benefit from the vaccine.
Because Gardasil only protects against some and not all types of HPV, promoting a more comprehensive education scheme would have not compromised Merck’s campaign. Merck’s rush to lobby state legislatures to require the vaccine for school entry, for example, seriously undermined the public’s trust in their motives. Instead of transparently lobbying (though perhaps an unrealistic expectation in American government), Merck used a number of indirect channels to promote state laws (for instance, Women in Government) that subsequently failed almost nationwide. Merck publicly announced it would no longer lobby state legislatures after the Texas governor overrode the state legislature debate. This sort of aggressive push devalues the real potential benefits the vaccine might offer young women.
It seems clear that there was an incredible opportunity available at the moment of Gardasil’s debut. A vaccine that protects against an STI that can slowly progress into cancer is a significant accomplishment. Offering women the opportunity to reduce their health risks and preempt an often painful and stressful set of morbidities associated with HPV infection was also a significant coup. Raising awareness about HPV, the difficulty in preventing it, and reducing cervical cancer mortality globally are all meaningful developments. But Merck did not manage any of these well and used its advertising campaign to manipulate women by playing on their ignorance or confusion about their health care. While the campaigns framed the decision to use the HPV vaccine as women’s own proactive involvement in their health care, the messages have been frightening and unsettling unnecessarily. Merck has handled its campaign irresponsibly, choosing not to frame the message simply and with straightforward information, perpetuating the notion that HPV and cervical cancer are a mysterious threat that can only be stemmed through vaccination. Since this is not true, and women will still get HPV and may still get cervical cancer, the message remains deeply problematic and even paternalistic.
By S.D. Gottlieb, MHS, PhD, anthropologist and author of the recent dissertation entitled, “Manufactured Uncertainty: the Human Papillomavirus and the Object Multiple.”