Challenging Dogma - Spring 2008

...Using social sciences to improve the practice of public health

Thursday, May 7, 2009

The Gardasil Campaign: Merck, Take a Look at it from a Public Health Perspective – Maithili Jha

In 2008, the American Cancer Society (ACS) estimated that 11,070 women in the United States were diagnosed with invasive cervical cancer, and 3,870 women died of cervical cancer (4). A leading cause of cervical cancer is human papillomavirus (HPV) that is passed sexually from one person to another (1). In response to both the rate of cervical cancer and the cause of cervical cancer, pharmaceutical companies have been racing to find a vaccine against HPV. One such pharmaceutical company, Merck claims that they have succeeded in finding a vaccine against HPV called Gardasil. Merck’s marketing approach to promote the drug was to lobby for mandatory vaccinations for 11 year-old girls in junior high, and infiltrate the media with the “One less” advertisement. The Food and Drug Administration and the Center for Disease Control have approved and recommended Gardasil, for women between the ages of 9 and 26. The FDA and the CDC also convey the message that women who are already infected with HPV will not be protected by the vaccine (5). While some may see the importance in vaccinating a female before potential exposure to HPV, others have seen Merck’s lobbying of mandatory vaccination of young girls in schools as a point of controversy and the “One Less” campaign as misleading. This paper will review and evaluate the means with which Merck has promoted the Gardasil vaccine, from a public health perspective.
The Premature Promotion of Gardasil, Merck could have used HBM
The FDA approved Gardasil for marketing and sale in 2006. Soon after, Merck began lobbying for mandated vaccinations in schools (14). The lobbying campaign ended in February 2007, but the opposition and views against compulsory vaccinations for a sexually transmitted virus still linger for two reasons. First, the vaccine was marketed and promoted before the entire public even knew what HPV was or that HPV may lead to cervical cancer. And, second, because representatives in at least 24 states and DC have initiated legislation to require vaccination in schools (9).
Rick Perry, the Governor of Texas, issued an executive order requiring Texan schoolgirls to be vaccinated against HPV. The conclusion that "the governor of Texas provided a solution to a problem before many were even aware of the problem. Educating the public after the fact is much harder” (11) remains even though three months after Rick Perry issued the order, he passed a bill undoing the mandate. Rather than using policy to market the vaccine, the promoters of Gardasil would have benefited from the use of traditional health behavior models such as the Health Belief Model. To an unaware public, education relaying the risks associated with HPV, marketing the benefits of preventing HPV, and addressing the perceived barriers to getting the vaccine may have muffled the backlash against expedited vaccinations.
In 2004, Holcomb, Bailey, Crawford and Ruffin conducted a study assessing adults’ knowledge of HPV. They concluded that adults seen in a physician’s office have a limited knowledge of HPV (7). In 2008, Gerend and Magloire conducted a similar study, and found that awareness of HPV was relatively high and increasing amongst sexually active individuals. They then went on to say that “With the release of Gardasil, Merck has since initiated its ‘One Less’ marketing campaign, which has received regular television airplay. High levels of awareness observed in the present study, coupled with the fact that television, radio, and magazines were cited as the most common sources of HPV information, provide some evidence for the effectiveness of these campaigns” (6). However, even though Gerend and Magloire’s study found that the awareness of HPV among sexually active individuals was relatively high, women who may have benefited the most from the vaccine, namely those who are not yet sexually active, were more likely to communicate the least interest in getting vaccinated (6). Had the campaign addressed the perceived risks of being sexually active and getting HPV, and the perceived benefits of being vaccinated, then maybe the parents or guardians of the eleven-year-old school girls and women who are not yet sexually active would be more receptive to the idea of endorsing and using Gardasil, and feel like they are at risk.
The perceived barriers associated with implementing mandatory vaccinations are multi-faceted. The monetary cost of Gardasil may be too high for some women, and calculating the return on the investment of being vaccinated may be difficult. The Gardasil vaccine costs $125 per dose, and $375 for the full series consisting of three vaccinations. While some health insurance companies may cover the costs being vaccinated, others may not (8). If a young girl is required to be vaccinated against the virus, and she does not have adequate health insurance then her parents or guardians would be forced to pay on their own. Once approached with a bill for a vaccine against a sexually transmitted virus, the parents and/or guardians may question why they should pay for a vaccine, if there is a chance their child may not get HPV. A parent’s acceptance of the idea of their child being sexually active is variable. As a writer for the National Health Federation states, “…many parents are opposed to making the vaccine mandatory, and in some states, like Massachusetts, the efforts have stalled. Some parents are opposed to mandatory vaccination on moral grounds, believing that vaccinating their daughters against a sexually transmitted disease sends the message that sexual activity at such a young age, or even prior to marriage, is acceptable. Others simply believe that the government has no right to usurp parental authority by mandating a vaccine for a disease that is not spread through casual contact” (2). Religious views, conservative values, education, and socio-economic status are all examples of what may affect how willing a parent is to consider the risks of their child being sexually active, even if their daughter will not be sexually active until she is older.
Mandatory vaccination of 11-year-old girls does not provide the parents and guardians with a sense of self-efficacy. Along with the vaccination, the lobbyists have not proposed a method for the parents to approach their daughters with the topic of sexual activity and consequences thereof. The mandate does not provide HPV education for the parents and children, leaving the parents and children to learn about the causes and effects of the virus on their own. Incorporating educational materials administered by the schools for the parents and children into the mandate may ease the transition into having children be vaccinated.
Social Cognitive Theory says, “Don’t just look at the 11 year-old, look at her environment too”
The Gardasil campaign failed to consider the individuals environment, when proposing mandatory vaccinations, and could have better incorporated how an individual responds to cues from the environment and visa versa, or reciprocal determinism into the campaign. In the 1960s, Albert Bandura proposed a behavioral theory that looked beyond the individual, and into the individual’s environment (3). He suggested that behavioral change is dependent on three constructs: individual characteristics, environmental factors, and reciprocal determinism (3).
Environmental factors like social norms, culture, and religion, affect an individual’s decisions. Before educating the public with the “One less” campaign or lobbying for mandatory vaccinations, the Gardasil campaign should have taken into account that the vaccine is to guard against the result of a behavior – sexual activity. In conservative groups, religious or political for example, the reception of learning about sexual behavior differs. A conservative Muslim woman may not be open to talking about her sexual behavior, or may not consider herself at risk for HPV, because of her conservative background and the understanding that she only has one partner. Yet, that Muslim woman is as much at risk of getting HPV as anyone else, simply because the virus is sexually transmitted. Merck should have borrowed from Bandura’s theory, evaluated the situations in which HPV occurs, and the perceptions of those situations within a social group by the individuals themselves (3).
Follow the Communications Theory, Avoid a False Sense of Security
As stated earlier, the Gardasil vaccine was the fasted drug to be approved and endorsed by the FDA and CDC. Because of this, the drug was prematurely marketed as a cervical cancer vaccine and not an HPV vaccine for certain strains. And, Merck’s marketing department and the lobbyists petitioning for mandatory vaccinations unsuccessfully communicated the vaccine’s purpose and benefits, while providing a false sense of security to the public (10). Previous public health campaigns had similar shortcomings until they started utilizing theories like the Communications Theory (CT). It is unknown as to whether Merck’s marketing department followed the CT when promoting Gardasil. But, it is apparent that when applying CT to the Gardasil campaign, weaknesses in Merck’s marketing approach begin to surface.
The Communications Theory states that one must consider the source of the message, the message itself, the channel by which the message is communicated, the receivers of the message, as well as feedback and understanding from the receiver (3). The Gardasil campaign is vulnerable to criticism, because it did not consider the message, the receiver, or whether there is feedback and understanding from the receiver.
Within the constructs of CT, the sources of the Gardasil campaign are Merck, lobbyists, and the policy makers in favor of mandatory vaccination. The message that Merck conveys in its “One less” campaign is that Gardasil is a vaccine against cervical cancer and that women should make the decision on their own, without the influence of policy to be vaccinated. The lobbyists say that schools should implement mandatory vaccinations. The lobbyists are sending a message that the vaccine will be effective if made mandatory by policy makers for grade schools, and this message is incongruent with Merck’s ad campaign highlighting personal initiative. Merck used media (television, print ads, news channels) and policy as the channels to convey their messages. In the “One less” campaign, the receivers of the message are the women receiving the vaccine, and the policy makers who could implement mandatory vaccinations. And, to the lobbyists, the receivers are the policy makers and other people able to influence whether the vaccine becomes a requirement for eleven-year-old school girls.
Either Merck should have enlisted the aid of public health organizations to formulate its message and educate the receivers that Gardasil is a vaccine against the strains of HPV that are the leading cause of cervical cancer, or they should have incorporated that education into their own advertisements. “One less,” that is, “one less woman with cervical cancer” does not relay why women should take Gardasil, a vaccine against HPV, resulting in a false sense of security against the cancer. The lobbyists and some policy makers have endorsed the idea of mandatory vaccinations of eleven year-old girls. Their proposals should include education plans for schools, physicians and parents about HPV, how it relates to cervical cancer, and behaviors leading HPV, instead of just proposing vaccinations.
Merck’s advertisements use young women and mothers as subjects. However, young women and mothers are not the only receivers in the campaign. On the one had, the lobbyists are saying that it is best to implement mandatory vaccinations for girls who are eleven and twelve years old before they are sexually active. And, on the other hand, Merck is not using eleven and twelve year olds as the subjects for their advertising, but young women making decisions on their own. Both the lobbyists and Merck’s advertising team are not taking into consideration other receivers of their message: the parents of eleven and twelve year old female students, those families and young women who cannot afford the vaccine for their children or themselves, the sexual partners of the women who are not infected with HPV yet, but could be in the future, religious and conservative groups, and physicians. Again, advertisements directed to parents of the children who would be vaccinated, as well as education programs for all the receivers of the message should be integrated into the campaign.
While it is difficult to gauge understanding of a concept, it is important for Merck and the lobbyists to continue market research on whether all the receivers know what HPV is, and what Gardasil does. Even if the eleven year olds do not fully understand why they are receiving the vaccine, the parents and guardians of the children should understand why they must vaccinate their children against a sexually transmitted virus.
Bridging Private and Public Domains
While this has not been a critique of Gardasil, the vaccine, but it has been a critique of Merck’s approach to promoting the vaccine. Public health is still developing and improving upon its models for influencing behavioral change, private companies such as Merck would benefit from utilizing established traditional and non-traditional health behavior models in their marketing campaigns, and promotions of therapeutics. By learning from the Gardasil campaign, one hopes that in the future private industry, and public health will be able to form a liaison and prevent the educational holes in the public’s awareness of pharmaceutical effectiveness.
Two-Step Marketing, a New Approach to Vaccine Promotion
When Merck used marketing techniques in combination with policy promotion for the Gardasil campaign, they had the potential to positively impact a wide population. However, Merck fell short of its potential. Instead of focusing on ways to limit controversy surrounding the nature of the virus, or barriers to receiving the vaccine, they rushed to have the vaccine approved and promoted by the FDA and the CDC, and lobbied for mandatory vaccinations of girls in grade school. This section will propose an alternative approach to promoting the vaccine, addressing the three previously stated arguments for why Merck’s Gardasil campaign failed, while staying within Merck’s constructs of coupling marketing and public policy. This new two-stage approach would allow Merck to use policy to influence its advertising schemes, and would allow policy to steer Merck’s advertising schemes as well, splitting the marketing efforts into two phases: education (Stage I), and product promotion (Stage II).
Premature Promotion of Gardasil Leading to an Uneducated Public : Stage I
Merck marketed the Gardasil vaccine using the “One Less” advertisement, before the entire public knew what HPV was or that it may lead to cervical cancer, resulting in the misconception that Gardasil prevents cervical cancer. To thwart this reaction, State and Federal lawmakers should propose legislation requiring the pharmaceutical company producing the vaccine to advertise their product in two stages. First, in Stage I they would need to use market research techniques to gauge the public’s knowledge about HPV and cervical cancer, and release a preliminary set of educational advertisements. Then, Stage II of advertising would be for the drug itself.
With a policy in place requiring pharmaceutical companies to assess the knowledge of the public about the product, Merck would need to find out how much people know about HPV, cervical cancer, and their relationships to sexual activity. Asking questions like: ‘Do you know what the vaccine guards against?’ ‘Do you know the causes of HPV?’ ‘Are you comfortable talking to your children who are under the age of twelve about sex, and the risks involved with sexual behavior?’ would provide insight as to whether the “One Less” campaign is informative or misleading. And, asking these questions would lead to the first stage of advertising involving education in HPV, not Gardasil. The ads may involve mothers and fathers talking to their daughters about HPV, or could be in the form of educational pamphlets and web-based seminars for health care providers
In return, Merck would not just lobby for mandatory vaccinations, but for vaccinations and HPV/vaccine education in grade schools. The education in the school systems would involve informing the parents and guardians of the children about the benefits of the vaccine, thereby minimizing the impact of addressing sexual behavior with children. Merck would be able to incorporate finding out when parents and guardians are comfortable with learning about HPV vaccinations into their market research efforts for Stage I. Thus, Merck would be able to determine how much time parents need to be educated in the subject, and lobby for the amount of parental education necessary.

Does one Ad Apply to Everyone, Everywhere? : Stage II
For Stage II, Merck would use all of the information gathered during the market research phase, and determine how answers to their questions may vary according to race, ethnicity, age, gender, culture, and socio-economic status amongst other variables. Currently, there are not many variations to the “One Less” advertisements. Merck, has not marketed to conservative groups, transgender individuals, immigrants, or partners of those getting the vaccine. By performing the necessary market research for Stage I, Merck’s marketing directors would understand the challenges faced with being from a conservative culture and bringing up the topic of sexual behavior with children, and the impact of a partner asking their loved one to be vaccinated.
In one example of a Gardasil commercial there are eight different women individually, in the form of a soliloquy saying they want to be “One Less.” And they are saying everything during the commercial in perfect English, and with “American” mannerisms. It is not until the last ten seconds of the ad do they show a group of young girls, jump roping, saying “O-N-E-L-E-S-S,” appealing to a group of people who collectively agree that one should be vaccinated with Gardasil. There is not a single example of a mother saying the importance of talking to their daughter(s) about HPV, a partner talking to another partner, be it a heterosexual or a homosexual relationship, about getting vaccinated, or an example of a religiously conservative person expressing the importance of the vaccine (12). By going through the steps of Stage I, Merck would have known that a Muslim mother still may not feel comfortable talking to their husband or boyfriend about being vaccinated or having their daughters vaccinated, after seeing the advertisement described above. And, Merck would understand that some cultures are more community oriented, and the opinions of others matter more than their own individual opinion. After doing the research, and learning about the different educational requirements for each culture, Merck might have benefited from including a group of ethnic women who do not speak perfect English, sitting together, discussing HPV in their ads.
Avoid a False Sense of Security, a Riled Up Crowd : Stage I & Stage II
On June 9, 2006, Gardasil was approved by the FDA. And, on November 23, 2006 Merck launched its print, online and television advertising campaign for the vaccine (13). By February of 2007, Merck had already started lobbying for mandatory vaccinations in schools. They had only been marketing the vaccine for two months with advertisements like the one involving eight women mentioned earlier. In that same ad, one woman says “Gardasil will not treat cervical cancer,” and the woman right after her says, “Ask your doctor about getting vaccinated with the only cervical cancer vaccine” (12). Merck prematurely marketed the vaccine as one that prevents cervical cancer to a public that, in two months of advertising, had not been educated in HPV, the causes of cervical cancer, the fact that HPV is not the only cause of cervical cancer, and that even if one is vaccinated they still might end up with the cancer. Once Merck started lobbying for mandatory vaccinations, the public knew two things: that Gardasil is a cervical cancer vaccine, and that HPV is related to sexual activity. Gardasil is not a cervical cancer vaccine, so the public was misinformed and had a false sense of security in the vaccine. And, even though HPV is caused by sexual activity, they were not ready to be introduced to a mandatory vaccine for a controversial topic: sexual activity.
Had Merck followed a two-stage process for promoting the vaccine, and included a broader educational portfolio into their marketing campaign, their lobbying attempts and advertisements may not have caused such a great sense of distrust in a FDA approved vaccine. Instead of releasing the Gardasil ads five months after approval, Merck could have waited, done the research for Stage I of advertising, and been more effective by gaining the trust of the public. The two-stage approach of educating and then promoting the vaccine would force Merck to fully inform the public in HPV, and then push for mandatory vaccinations. By the time the lobbying efforts would be known to the different communities, the individual people making up the communities would be more accepting to the idea of having their daughters vaccinated, and they would have understood the value in having mandatory vaccinations in schools.
Conclusion : Money was not Discussed, and it won’t be
The two-stage approach to promoting a vaccine discussed in this paper, does not take into consideration the monetary impact of having twice as many marketing campaigns. However, one would hope that for FDA approved vaccines, and products affecting a person’s health, pharmaceutical companies will be able to fabricate, and re-organize their Research and Development and Marketing budgets to allow for better education of the public, and find value in equating education and product promotion. And, one would hope that lawmakers would see the benefit in aiding pharmaceutical companies in providing more information on the vaccines and the viruses. Maybe, one day it will become common practice to conduct Stage I type activities while doing clinical trials for the vaccine or drug at the same time. But, until education and product promotion have equal weight in the public and private sectors, we will continue to have vaccines quickly marketed to an ignorant public, and public opposition to effective vaccines.
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