Challenging Dogma - Fall 2007

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

Monday, December 10, 2007

The Gardasil® “One Less” Campaign: How a Power Coercion Approach Will Fail to Address the Public Health Problem of HPV – Ryan Borg

The decade long search for a vaccine against human papillomavirus (HPV) is now over. In June 2006, the Food and Drug Administration approved the first HPV vaccine (1, 2). Merck & Co.’s vaccine, called Gardasil®, is truly a scientific breakthrough. Merck markets the vaccine as a protective agent against cervical cancer and advertises through the “One Less” campaign, which is targeted to young women and adolescents.
HPV is the name of a group of viruses that includes over 100 different strains or types, over 30 of which are sexually transmitted (1). HPV is the most common sexually transmitted infection (STI) in the United States. An estimated 20 million people are currently infected with HPV, about 6.2 million Americans are diagnosed with HPV infection each year and approximately 50 percent of sexually active men and women will become infected at some point in their lives (1). Most HPV infections are asymptomatic and individuals are usually unaware that they are infected. For the majority of women, the body’s defense system will naturally clear the infection. Occasionally, when HPV is untreated, it can cause cervical cancer and genital warts. Approximately 11,000 newly diagnosed cases of cervical cancer occur each year in the United States, and approximately 3,700 women die from cervical cancer annually (1-3).
Some strains of the virus, referred to as “high-risk” types, have been identified as causal agents for cervical cancer. “Low-risk” types are associated with the development of genital warts (2). Warts, pre-cancerous and cancerous cells of the cervix are detected by Papanicolaou (Pap) cervical screening tests. Abnormal test results indicate precancerous changes in the cells or the presence of genital warts. When pre-cancerous cells are detected, Pap tests are used to monitor the cells as different medical treatments are used to stop the progression of cancer. Since regular pap testing has been used in cervical screening programs throughout the United States, the number of deaths from cervical cancer has been greatly reduced (1 -3).
Gardasil® is a prophylactic HPV vaccine against types 6, 11, 16, and 18. HPV types 6 and 11 are low risk and cause approximately 90 percent of genital warts, and HPV types 16 and 18 are high risk and cause approximately 70 percent of cervical cancers (3, 4). The FDA approved the vaccine for use in girls and women between the ages of 9 and 26 and the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices (ACIP) recommend routine vaccination of girls aged 11 to 12 years (3). The ACIP recommends that girls ideally receive the vaccine before they are sexually active because the vaccine is the most effective in females that have not yet contracted any of the four HPV types. The clinical trials conducted have concluded that Gardasil® is nearly 100 percent effective in preventing infection and disease associated with the four HPV types in the vaccine and no serious side effects have been observed (3-5).
This vaccine has the potential to have an impact on public health by reducing the incidence of HPV and cervical cancer in the population. However, Merck’s “One Less” campaign is advocating and advertising new technology at the expense of ignoring important and intricately linked ethical, behavioral, psychosocial and medical factors that are associated with the virus, its transmission, and its consequences. Thus, the “One Less” campaign is an inappropriate health intervention for HPV when used without education and appropriate medical care.
Merck’s Power Coercive Approach Does Not Address the Behavioral Factors Associated with HPV Transmission
Once approval was granted, Merck aggressively lobbied legislatures to make the Gardasil® vaccine mandatory for adolescent girls and financed efforts to persuade state and public officials to pass mandatory vaccine laws (6). Recently, the manufacturer withdrew its political campaign because of controversy and opposition from parents, patient advocacy groups and public health officials (6, 7). One cannot help but wonder about Merck’s motives for lobbying and question if the company had a hidden agenda. If mandatory legislation was passed on a nationwide scale, the vaccine would be administered to approximately 2 million girls between the ages of 11 and 12 (6). Merck stands to make billions from Gardasil®. Merck is using its wealth and power to attempt to coerce legislatures to pass mandatory vaccine laws. However, passing a law that forces individuals to receive the vaccine will not solve the real problems at hand. A law will not compel individuals to have safe sex and see a doctor regularly. Thus, Merck’s campaign is an inappropriate way to address the public health problem of HPV and cervical cancer.
The “power coercive” strategy adopted by Merck is built upon the utilization of power, usually in a political and economic context. Those with power decide what is important and use political and economic power to make those with less power comply (8). This is the strictest strategy that can be employed in an attempt to elicit behavioral change. Commonly, power is used to enforce sanctions that aim to punish those that do not comply to the proposed change. Other strategies focus on moral power as a way of eliciting behavior change (8). The power-coercive approach to making decisions and changing behaviors is relatively common in our society. In particular, the field of public health is no stranger to the strategy of power coercion. It is common for public health officials to enforce health related regulations and legislations in order to protect the citizens of the community (9). For example, vaccinations against childhood diseases such as polio, mumps, measles and rubella have been mandated by public health officials as necessary before a child starts school. However, a major difference exists between the mandatory school vaccines and the proposed mandatory HPV vaccine. The childhood diseases are easily communicable and casually contracted (6, 10). HPV is transmitted through sexual contact with another infected individual. Thus, a mandated HPV vaccine would essentially be an attempt to control individual behaviors. Legislations and regulations of this kind are the most invasive approaches to public health promotion (9, 10).
As of now, this is not a true power coercion approach because the vaccine is not yet mandatory. This may change due to the success of Merck’s original lobbying. Texas was the first state to make HPV vaccine mandatory for girls entering sixth grade. According to the executive order passed by Governor Rick Perry, beginning in September 2008, girls entering sixth grade (usually aged 11 and 12 years) would have to be vaccinated. Texas has since voted to overturn the governor’s order, but 20 additional states are considering passing similar legislations (6). This may provide the impetus Merck needs to start lobbying again.
Many different arguments are made for why the HPV vaccine should not be made mandatory. Ethical concerns, economic constraints and the unknown long term effects of the vaccine are among the most commonly cited arguments (6, 7, 10). However, the underlying issue here is that the power coercion strategy utilized by Merck will not function as an effective intervention because the fundamental causes of HPV transmission are not addressed by a mandatory vaccination law. HPV is transmitted through sexual contact. Risk factors that make adolescents vulnerable to contracting this virus need to be identified and the behaviors that make individuals inclined to engage in these risks need to be understood. The behavioral risk factors that have been associated with HPV infection include engaging in sex with multiple partners and risky sexual practices (10, 11). In a comprehensive literature review conducted by Buhi and Goodson (2007), a variety of factors that influence sexual behavior were investigated. Intention and perceived norms were commonly identified as predicators of sexual behavior outcomes. Adolescents that intended and wanted to have sex were more likely to initiate intercourse and engage in progressively riskier situations and adolescents that believed their peers were having sex were more likely to engage in sex themselves (12). Adolescents’ and teenagers’ perceived vulnerability to STI’s is another significant predictor of sexual behavior. When teens do not believe that the disease is serious or that they are vulnerable to contracting it, they are less likely to abstain from sex or use condoms (13, 14).
Merck’s lobbying and advocating for mandatory vaccine laws does not address these behavioral risk factors nor does it offer teens strategies to avoid these risk factors or ways teens can protect themselves against these risk factors. While the Gardasil® vaccine is effective in protecting against certain types of HPV, it is not effective in preventing or lessening the risk factors that make teens vulnerable to the virus. A limitation of the power coercive approach is that the psychosocial and behavioral factors that are intricately linked to the situation are not taken into consideration. The Gardasil® vaccine may prevent an individual from becoming infected, but understanding why individuals make themselves susceptible to infection in the first place will have the greatest and most long term impact on improving health outcomes.
The “One less” Campaign Sends a Misleading Message that May Result in Unintended Negative Consequences
Since power coercive strategies typically utilize political and economic power to force change, an educational component is often ignored. It is important to note the lack of education regarding HPV and cervical cancer among the general population, and specifically among women. Many studies have found that adolescent women have a very limited understanding of HPV, and that knowledge is often inaccurate or misconstrued (15, 16). Other studies have found that few women are aware of the link between HPV and cervical cancer and most do not understand the meaning of normal and abnormal Pap test results (15). These studies show that women have little levels of knowledge about the virus they are most at risk of contracting and suggest that women do not have the information they need to make educated decisions about sexual practices or appropriate assessments of their risk to STI’s (16).
Researchers have also found that parents are not well informed about HPV and cervical cancer. If the vaccine is mandated in school aged girls, parents will have to give consent to allow their daughter to be vaccinated. Thus, parental knowledge and attitudes are important (17). It is pertinent for adolescents, teens and parents to have an accurate understanding of HPV and the relationship between HPV and cervical cancer in order to make the most suitable prevention decision (15, 16).
Since Gardasil® does not protect against the types of HPV that are not included in the vaccine, there is still risk that needs to be accounted for by safe sex practices and cervical cancer screenings. Since many women do not have a solid understanding of the virus and cervical cancer, they may mistakenly interpret the Gardasil® message to mean that the vaccine will protect them from all HPV types and also from developing cervical cancer (18). However, this is not the case. This misleading message may result in unintended negative consequences by giving vaccine recipients a false sense of protection. Individuals that receive the vaccine may have a change in STI risk perception. HPV immunization could lead teens to believe that they are not as susceptible to other STI’s or it could lead teens to assume that their partner is “safe” because they are vaccinated. Teens may subsequently engage in more risky behaviors such as having sex with multiple partners and not using protection (10, 19).
The misleading message may also cause recipients to forgo regular Pap screenings. Women may believe that being vaccinated absolves them from having to get Pap tests done regularly. Screening is still necessary since HPV infection and cervical cancer can still occur in a vaccinated individual (19, 20). The effect of this misunderstand information can be especially harmful for women are diagnosed with HPV before being vaccinated. It is vital for this population to see a doctor and be screened regularly to monitor the abnormal cell changes (19).
The “One Less” campaign does not provide potential consumers with complete information about HPV and cervical cancer. Merck is not advertising responsibly because they are not taking the overall lack of knowledge about HPV in the general population into consideration (10, 19). The important message regarding the seriousness of the HPV problem could be addressed more effectively using a rational-empirical approach. A rational-empirical approach is an educative strategy that uses rationalization to elicit before change. Thus, if women had enough knowledge to rationally evaluate how engaging in risky behaviors can lead to HPV infection, and how HPV infection would affect their overall quality of life, they may be motivated to change their behavior. While the vaccine is effective to a certain extent, the rational-empirical approach could be used to send a more complete message to women about the disease (8). Educating women about HPV transmission and infection could empower them to make better decisions about their sexual lifestyle and encourage them to take responsibility for their sexual and overall health.
Merck’s Campaign Does Not Effectively Address the Barriers to Receiving the Vaccine
Just because a vaccine is available and effective does not guarantee its use and acceptability (16, 19). Many barriers can be identified that would prevent an individual from receiving the Gardasil® vaccine. The barrier that is most commonly mentioned is the high cost. The vaccine is extremely expensive; it costs about 120 dollars per dose, totaling about 360 dollars for the full series (5). It may not be covered by insurance companies, which places a burden on parents or the recipient to pay high out of pocket costs and also places a burden on the health care provider who may not be adequately reimbursed (18). Compliance may prove to be another obstacle. The vaccination is designed to be administered in three doses over the course of six months. Compliance may be high for the first injection, but than decrease as time progresses (20). Researchers have not yet discovered what happens to the effectiveness of the vaccine if the full series of shots is not administered (20).
Access to care is also a barrier. Individuals who want to get the vaccine must have access to a primary care physician or gynecologist. As of now, those that do not have a regular doctor do not have an easy way of receiving the vaccine (18). Access to care is especially important when looking at populations at risk. Often, the most at risk population has the least amount of access. Studies have shown that HPV rates are higher among minorities and low socioeconomic classes (21). These are the populations that would benefit the most from a prophylactic vaccination; however, these are also the populations that have the least amount of access to health care (21).
Health beliefs regarding HPV and the vaccine may also act as barriers. There is still a stigma associated with STI’s in our society. When a woman accepts the vaccine, she is explicitly recognizing that she is vulnerable to STI risk. Or, a woman may feel like receiving the vaccine is admitting that she takes sexual risks. Fear of being viewed negatively by friends, family, and society may create an obstacle between a woman and the vaccine (16, 19).
Parental beliefs may also create obstacles for vaccinating young female adolescents. Parents may not believe that their daughters need to be vaccinated against an STI when she is not yet at risk of becoming infected. Parents may feel the potential risks of the vaccine outweigh the benefits if they have a young daughter that is not yet sexually active. Additionally, parents may believe that giving consent to the vaccine is condoning premarital sex or risky sexual behavior (20). Pre-teens that will need parental consent may want the vaccine but may not feel comfortable discussing sexual activity with parents (19).
Lastly, the novelty and mystery of the vaccine may be an obstacle. Since the vaccine is so new, long term data is not yet available. Researchers do not know how effective the vaccine will be ten years after it is administered. The effects the vaccine may have on future pregnancy or other health outcomes are also unknown. This lack of long term knowledge may deter some people from receiving the vaccine (19-21).
Merck launched the “One Less” campaign and started lobbying legislatures as soon as Gardasil® was approved. Not enough consideration was given to the barriers and obstacles that may prevent some from receiving the vaccine. In this way, Merck used its power at the expense of the public’s health. Thus, it is important that researchers, health care providers, and public health officials continue to investigate the long term outcomes of the vaccine and develop ways to overcome the barriers inherent in its distribution.
Conclusion
The burden of cervical cancer is enormous; it is not just a health burden, but a burden emotionally and psychologically as well. The ability to prevent specific types of HPV and the potential to reduce the number of cervical cancer cases is a huge stride in the medical and public health fields. However, the prevalence of HPV and the relatively high mortality rate of cervical cancer calls for more than a vaccine to solve these problems. Instead, the HPV vaccination needs to become part of a comprehensive health promotion and intervention strategy. The rational-empirical approach needs to be used in order to educate people about the virus, the disease, and ways in which the virus is transmitted. A biopsychosocial approach needs to be used in order to understand why individuals engage in risky sexual behaviors that make them vulnerable to the virus. A policy approach needs to be used in order to address barriers to the vaccine. The most effective intervention strategy will be the one that draws upon many different medical and public health disciplines in order to address the fundamental causes of HPV infection.
REFERENCES
1. Department of Health and Human Services: Centers for Disease Control and Prevention. Genital HPV Infection Fact sheet. Atlanta, GA: Centers for Disease Control and Prevention. http://www.cdc.gov/std.
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