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.
References
"Cervical Cancer Basic Information." Centers for Disease Control and
Prevention: Your Online Source for Credible Health Information. 22 Dec. 2008. Department of Health and Human Services. 27 Mar. 2009.
2."Efforts to Make Gardasil Mandatory Stall in Some States." The National Health Federation: A Not-For-Profit Health-Freedom Organization. 24 Apr. 2008. National Health Federation. 4 Apr. 2009.
Edberg, Mark. Essentials of Health Behavior: Social and Behavioral
Theory in Public Health. Boston: Jones and Bertlett, 2007
4. "Facts about Cervical Cancer." Michigan Cancer Consortium. Feb. 2009. Michigan Department of Community Health. 4 Apr. 2009.
5. "FDA Licenses New Vaccine for Prevention of Cervical Cancer and Other Diseases in Females Caused by Human Papillomavirus." U.S. Food and Drug Administration. 8 June 2006. U.S. Department of Health & Human Services. 27 Mar. 2009.
6. Gerend, Mary A., and Zita F. Magloire. "Awareness. Knowledge, and Beliefs about Human Papillomavirus in a Racially Diverse Sample of Young Adults." Journal of Adolescent Health 42 (2008): 237-42.
7. Halcomb, Bryan, Joanne M. Bailey, Kathleen Crawford, and Mack T. Ruffin IV. "Adults' KNowledge and Behaviors Related to Human Papillomavirus Infection." Journal of the American Board of Family Medicine 17 (2004): 26-31.
8. "HPV Vaccination Information for Young Women." Centers for Disease Control and Prevention. 26 June 2008. Department of Health and Human Services. 27 Mar. 2009.
9. "HPV Vaccine." National Conference of State Legislatures: The Forum for America's Ideas. Apr. 2009. 4 Apr. 2009.
10. Jones, Bethany. "Gardasil Marketing Campaign for Cervical Cancer Misses the Mark." Associated Content: Information from the Source. 10 Oct. 2007. 27 Mar. 2009.
11. "Mandatory Vaccination with Merck's Gardasil Raises Eyebrows." Seeking
Alpha. 7 Feb. 2009. 23 Mar. 2009.
12. Merck. "Gardasil Commercial." YouTube. Nov. 2006. .
13. "Merck Launches National Advertising Campaign For GARDASIL, Merck's
New Cervical Cancer Vaccine." Medical News Today. 23 Nov. 2006. 27
Apr. 2009 .
14. "Merck lobbying States to mandate Gardasil for school girls." News-Medical.Net-Medical and Health News Headlines. 30 Jan. 2007. 4 Apr. 2009.

Become One Less Victim to Merck: How the Department of Public Health is Failing to Intervene Upon Merck’s “One Less” Gardasil Campaign Through its ...

Disregard for the Safety of Young Girls, Socioeconomic Status, and Lack of Marketing Strategy- Dominique Devaris

The Human Papillomavirus (HPV) is the most common sexually transmitted virus in the United States. According to the Center for Disease Control (CDC), there are about 40 types of HPV. About 20 million people in the U.S. are infected and about 6.2 million more get infected each year (1). Most HPV infections do not cause any symptoms; they actually go away on their own (1). However, HPV has become increasingly important mainly because it can lead to cervical cancer in women who do not undergo regular gynecological exams. In the U.S. about 10,000 women are diagnosed with cervical cancer each year and 3,700 die from it. Globally, about 493,000 new cervical cancer cases occur each year with 274,000 deaths; which means that more than 80% of cervical caner deaths worldwide occur in developing countries (2), HPV has without a doubt become a significant national and global public health concern.

On June 8, 2006, the FDA approved Gardasil as the first prophylactic quadrivalent HPV vaccine. According to the Merck product website, Gardasil will protect girls and women ages 9 to 26 from HPV types 16 and 18, which causes about 70% of cervical cancer, as well as HPV types 6 and 11 which is known to cause about 90% of genital wart cases (3). Within a few months of the FDA’s approval of Gardasil along with recommendations from the CDC and Prevention Advisory Committee on Immunization Practices (ACIP), about 20 states had legislation pending approval for mandating Gardasil to girls as young as 9 (4). Mandating a new vaccine for HPV, one of the causes of cervical cancer, to elementary school girls has caused a great deal of controversy within many states across the country. According to Berger, there are certainly legitimate concerns for this heated debate, including the rapid pace at which legislation is moving forward, the lack of education for parents on the issue, the undue influence of pharmaceutical giant Merck on state legislators, and the tremendous cost of the vaccine (5).

A Costly Mandate

Setting aside the political concerns on mandating Gardasil, let us first consider how the DPH has failed to provide sufficient funding for this mandate and government subsidization for those who cannot afford Gardasil. The American Academy of Pediatrics is not advocating the mandate of Gardasil and one source of opposition from pediatricians is cost (6). According to Siers-Poisson each vaccine shot can cost about $120 through private insurance, or $96 through governmental programs buying at federal rates (4). According to the Kaiser Network some Detroit-area physicians say that the full cost of the vaccine, which is given in a series of three injections over a six-month period, is about $450 per child without insurance (7). That is a steep price tag for families that have 3 daughters and fall into the socioeconomic statues of poor working class. As stated in the PRwatch article, the poor working-class are the people that most often do not have health care through their employer, they also tend not to qualify for government assistance, and these are also the same families that do not receive regular Pap tests to detect early pre-cancerous conditions (4). Knowing these facts, one must ask themselves why the Department of Public Health has not launched a campaign that targets people of those socioeconomic statues to provide free routine physicals and Pap tests. A project as simple as having a Pap mobile van to perform Pap smears and educate women in the areas that contain socioeconomically disadvantaged females can potentially cause a drop in the rate of HPV per year. After all, several lawmakers have said that their motivation in supporting mandatory HPV vaccines was to ensure widespread inoculation and to erase economic disparities in cervical cancer, which is most common among low-income women who are the least likely to have Pap smear screening (6). Therefore, if such a project as the Pap mobile is not done, than mandating Gardasil could potentially widen the cervical cancer disparity for those who are uninsured and rely on government programs for health care.

Undoubtedly the idea of mandating a HPV vaccine to elementary school girls as a prerequisite for school attendance, especially since the government does not have the funds to fulfill that every child who cannot afford it gets vaccinated, is inappropriate and erroneous to most. Never should a child’s education be compromised due to the parent’s inability to pay for a HPV vaccine, because as stated in the Gostin and DeAngelis article, unlike the other mandated school vaccines, HPV is not a highly infectious airborne disease, which is the paradigm for the exercise of compulsory vaccination. Since the HPV vaccine is not immediately necessary to prevent harm to others, this mandate most certainly needs to be more carefully thought out (8). The National Cancer Institute even tells us that if a woman gets an HPV infection that results in epithelial dysplasia they can be cured by stating; “properly treated, tumor control of in situ cervical carcinoma should be nearly 100 percent” (9,10). We must wonder why the DPH failed to start a “Mandate One Less Girl to get Gardasil” campaign (MOGG), when it is known that nature inoculates us with-and against-this virus (10).

Another important aspect of cost is the boosters that will be needed after a certain amount of time. Merck cannot say whether a booster will be needed between five or ten years since its follow-up of participants is short, but it is expected that a booster shot will be needed. Therefore the price of Gardasil just jumped from the initial $450 plus the additional cost of administering each booster series over the course of a sexually active woman’s life.

DPH Fails to Recognize the Risk of Administering Gardasil Along With Other Recommended School Immunizations

Everyday new adverse findings are being reported to the federal Vaccine Adverse Event Reporting System (VAERS) when Gardasil in co-administered with other vaccines in young women. Yet, the DPH has not tried to prevent the CDC and The Prevention Advisory Committee on Immunization Practices (ACIP) from recommending that young girls get Gardasil shots as part of their immunization records. According to the National Vaccine Information there have been 1,930 reported Gardasil adverse events when Gardasil was administered alone and 7 deaths, 239 cases of syncope, 135 adverse events with Menactra (meningococcal vaccine), a couple of adverse event cases with Varivax (chicken pox vaccine), and a 1,130 percent increase in reported GBS (Guillian-Barre Syndrome) when co-administered with another vaccine (11). Nobody at Merck, the CDC and FDA knows if the injection of Gardasil into all pre-teen girls-especially simultaneously with Hepatitis B vaccine-will makes some of them more likely to develop arthritis or other inflammatory autoimmune and brain disorders as teenagers and adults, says Mrs. Fisher (12). Merck has even stated on their website that co-administration of Gardasil with other vaccines except for Hepatitis B has not been studied (3).

As Barbara Fisher, NVIC co-founder and president said, “parents have the right to expect proof of safety and not assumption of safety before new vaccines, like Gardasil, are given simultaneously with other vaccines to their children” (11). An important change here would be for the DPH to be more involved in whether or not a vaccine should be mandated rather than political officials. As stated by Gostin and DeAngelis, it is inappropriate for Merck to finance efforts to persuade states and public officials to make HPV vaccinations mandatory, particularly soon after the product was licensed. Private wealth should never trump public health (8). Yet again the DPH has sat back quietly and allowed the CDC and ACIP to make these recommendations to the public and public officials and fail to implement some sort of educational campaign that would let parents in on all these negative known facts of Gardasil in conjunction with the other required school vaccines. Knowledge is power and I believe that knowledge leads to wiser, more informed choice (13).

DPH Failed to Use Marketing Strategies to Combat Merck’s “One Less” Campaign

The DPH failed to adequately market and educate the public about the doubts and risks associated with Gardasil. Before Gardasil was approved by the FDA, facts about the rise of HPV were all over the news and internet. According to Siers-Poissons, in 2005 Merck started its marketing by funding a campaign called “Make a Connection,” which was run by the Cancer Research and Prevention Foundation (CRPF) and the celebrity charity Step Up Women’s Network (4). This allowed Merck to partner up with non-profit organizations that had women’s health issues as their primary concern. If we look closely Merck has portrayed HPV as if it were a new disease. Prior to Merck’s ads and commercials in 2005, over 75 percent of women have never heard of HPV (13). This is a marketing technique known as “disease mongering.” In Dr. Moynihan and Henry views, disease mongering is the selling of sickness that widens the boundaries of illness and grows the markets for those who sell and deliver treatments. It is exemplified most explicitly by many pharmaceutical industry–funded disease-awareness campaigns—more often designed to sell drugs than to illuminate or to inform or educate about the prevention of illness or the maintenance of health (14). One may look at the definition of “disease mongering” and say that it is similar to the Health Belief Model because they both encompass perceived severity and perceived susceptibility. The difference here is that the public health’s perceived severity and perceived susceptibility in the Health Belief Model, is not about raising awareness so that there can be a financially gain, but rather they are used to provide insight for why people should make healthier decisions and create a process for encouraging that change.

Merck also used fear of cancer as a marketing tool. Merck’s president for vaccines, Margaret McGlynn, acknowledged that there was a sense of urgency for Gardasil, so that it can eradicate HPV by stating: “Each and every day that a female delays getting the vaccine there is a chance she is exposed to the human papillomavirus” (6).

In 2005 Merck launched a $27.4 million ad campaign using what is known as a viral marketing technique, which was a “Tell Someone” you love pledge campaign about the growing rate of HPV. According to Siers-Poissons, The Bloomberg reporters calculated that Merck spent $841,000 for internet ads on HPV’s link to cervical cancer in the first quarter of 2006 alone. In April 2006, they bought 295 TV advertising spots for the HPV campaign, followed by 788 spots in May (4). Yet, Merck did not get the FDA’s approval for Gardasil until June 2006. Currently Merck has the “One Less” campaign, where they want girls and parents to ask their doctor for the HPV vaccine that will prevent them from getting cervical cancer, by name. In this TV ad we see young vibrant active athletic young women saying they want to become “One Less” victim to HPV and parents believe it. This “One Less” campaign is using an emotional marketing approach by playing on every parent’s emotion and making them think that they are not good parents if they do not protect their child from cancer. Merck also used power as a weapon in the “One Less” campaign by incorporating a sense of female empowerment, making young girls and women believe that they can prevent themselves from having HPV by getting their recommended 3 shots of Gardasil (10).

The DPH on the other hand has a budget of $18.2 million towards its health promotion and disease prevention programs. However, only $1 million of this $18.2 million goes towards infection prevention and the rest of the money is being split amongst many programs including, but not limited to, breast cancer prevention, prostate cancer screening, ovarian cancer prevention, stroke awareness programs, Hepatitis C prevention, smoking prevention and cessation, teen pregnancy, and suicide prevention.

A huge DPH failure is that they failed to use the agenda-setting theory first. The DPH should have been the primary ones to bring up and discuss the facts about HPV to the public, not a pharmaceutical company. Merck on the other hand has used about four to five different marketing techniques to try and reach various markets. Yet, the Department of Public Health has only posted facts and figures about HPV on their website and has not put out one TV ad combating the use and risk of Gardasil, not even on a free advertising website such as YouTube. In fact when we click on the DPH website they are promoting Gardasil and offering subsidized forms for those who cannot afford it. Instead of allocating more money towards marketing for a HPV/ Pap smear campaign, Governor Patrick has allocated $24.8 million dollars towards the Massachusetts Immunization program, so that 72,126 girls between the ages of 9-18 can receive the HPV vaccine in 2008 (15) . Clearly these figures show that the DPH and Merck do not have equal funding. Yet, the DPH has failed to even advertise on free progressively popular social networking websites on behalf of the DPH, such as MySpace and Facebook, to combat and educate the public about the risk of Gardasil in order for people to make an informed decision.

DPH is Disregarding the Safety of Young Girls

The DPH has failed to challenge the idea that girls ages 9 and up who are being targeted to get the HPV vaccine, is a public health experiment by Merck. The CDC and ACIP, who are in charge of deciding whether to recommend a vaccine by weighing a host of factors, including efficacy, benefits and risks, and cost-effectiveness, have decided to endorse the HPV vaccine (16). This decision by the committee seemed rushed and is noticeably flawed, since Gardasil has limited efficacy and safety data. With limited data on which to base an assumption of long-term safety, the “post-marketing” crowd, which are young girls ages 9 and up, will therefore serve as Merck’s guinea pigs in order for Merck to see the true side effects, durability, and efficacy of Gardasil (10).

On Merck’s website, their clinical trials shows that they had less than 12,000 participants with a limited follow-up period of about 5 years, with the majority of the participants being followed for only 18 months (8). This may seem like a large number of participants, but less then 1,200 of these girls were under 16 years of age and a few were at the sensitive age of puberty. This suggests that the optimum target group that the vaccine will be mandated for was grossly under-represented in Merck’s clinical trials and followed up for the shortest amount of time (10). Merck also notes that it only test girls 9 to 15 years of age for safety and immunity responses, but not for efficacy (3).

Another danger is that HPV can increase by 44.6% in girls who carry the same HPV strains used in the vaccine. Gardasil could potentially “activate” and accelerate the development of precancerous lesions (17). This increases instead of decreases the rates of cervical cancer. In the JAMA article entitled, “Effect of Human Papillomavirus 16/18 L1 Viruslike Particles Vaccine Among Young Women with Preexisting Infection” the authors concluded that “no significant evidence of a vaccine therapeutic effect was observed in analyses restricted to women who received all doses of vaccine or those with evidence of single HPV infections at entry.” This means that over a 6-12 month period that this study followed-up with their subjects there was no difference in the rate of viral clearance from the control group verses those who received Gardasil.

Yet, the DPH, CDC, and ACIP continues to support the mandate for Gardasil to be administered to about 2 million girls as young as 9 years-old, for a virus that is short-lived and can clear up on its own. DPH has even failed to let people know on their HPV fact sheet that there are many other causes and factors that can contribute towards cervical cancer besides HPV, or that there are lifestyle changes that can reduce the risk of getting cervical cancer. Safer sexual habits such as celibacy, not having many sexual partners, and not having sex with uncircumcised males would be an excellent life style change that can reduce the risk of cervical cancer (10).

Smoking is a major cofactor because a woman who smokes is twice as likely to get cervical cancer then nonsmokers. Tobacco smoke can produce chemicals that may damage the DNA in cells of the cervix and make cancerous cells more likely to become present. HIV infected women are also more susceptible to cervical cancer because of their weakened immune systems. A proper diet also plays a major role as well, because women who are overweight and have a low fruit and vegetable intake are at greater risk for cervical cancer (19). According to Dr. Sedjo, women whose diets are high in vegetables were 50% less likely to have long-lasting HPV infections, therefore less likely to develop cervical cancer. Dr. Sedjo also found that the presence of one particular nutrient, lycopene-found primarily in tomatoes, watermelon and pink grapefruit-guarded against long-lasting HPV infections (10, 20). Being low income also puts women at greater risk, because women of that socioeconomic status tend to not have or cannot afford health insurance, which would lead to them not having routine Pap tests (19). This visibly demonstrates that the DPH has been failing to stop the prevalence of HPV, by not establishing a Pap test campaign that would precisely target women of that socioeconomic status.

The CDC/ACIP/FDA has also failed the public by not making an informed, unbiased decision in determining whether or not to recommend the vaccine. This seems to have become an issue of private wealth instead of public health. Merck is a pharmaceutical company whose goal is to research, develop, and sell drugs. Pharmaceutical companies do not particularly care about the public health and because of that the publics trust has weakened in them. Merck has a lobbying campaign and has been putting heavy pressure on state legislators to rapidly pass a mandatory vaccination law before GlaxoSmithKline, an HPV vaccine competitor, gets approved as well (5). This says to people that Merck’s main concern is not about young women’s health but rather about Merck’s annual $1.4 billion profit. According to Cynthia Dailard’s article, the CDC and ACIP in addition to FDA’s approval decides whether to recommend a vaccine, the committee of 15 must weigh a host of factors, including efficacy, benefits and risks, and cost-effectiveness (16). This makes one question whether or not the public’s health was a concern for the committee this time around because it is impossible for this committee to have deemed Gardasil cost-effective at about $450 for a three shot series, having long term efficacy since its clinical trials say that the follow-up period is about 4 years, with the majority of participants being followed for only 18 months.

Conclusion

Cervical cancer is a horrible disease that primarily affects 80-85% of the women in developing countries (16) and only about 1% of cancer deaths in American (12). Looking at these facts and figures we see that the U.S. has been able to control a huge percentage cervical cancer through annual physicals and Pap smears, therefore seeming unnecessary to fast track a HPV vaccine. Most of the women who do suffer from cervical cancer are of a lower socioeconomic status (SES) and therefore do not have healthcare access to get routine physicals and pap smears. It is known that the three shot Gardasil series cost about $450, not including the possible booster shots that women will need in the future, so how then does the CDC and ACIP plan on driving down the rates of HPV when the people typically affected by HPV will not be able to afford Gardasil even if subsidized. Yet, the DPH and the Department of Health and Human Services seem to be supporting the mandating route, while failing to start a campaign that would provide routine gynecological exams and other inexpensive screening measures for HPV. This would not only protect people from the side effects of a short-lived vaccine but it would lower the burden of HPV for far less the cost of Gardasil. In fact, the more government money spent on subsidizing Gardasil, the less money is made readily available to the poor for gynecological care. Since Merck stands to profit from widespread vaccine administration, it is inappropriate for Merck to finance efforts to persuade states and public officials such as, the CDC, FDA, ACIP, WIG and DPH, to make HPV vaccination mandatory, particularly so soon after the product was licensed. Therefore, in the absence of an immediate HPV crisis, mandating Gardasil as a means for private or personal wealth should never supersede the public’s health.

REFERENCES

1. Center for Control Disease and Prevention (CDC). HPV Vaccine What You Need To Know [press release]. February 2, 2007.
2. Parkin DM. The global health burden of infection-associated cancers in the year 2002. Int J Cancer. 2006;118:3030-3044.
3. Merck. GARDASIL [Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine], 2006. www.gardasil.com
4. Siers-Poisson, Judith. Politics and PR of Cervical Cancer, 2007. Available at http://www.prwatch.org/node/6186.
5. Berger, Sam. Mandatory Opposition. Center for American Progress, March 12, 2007. Available at: http://www.americanprogress.org/issues/2007/03/hpv.html
6. Saul S, Pollack A. Furor on rush to require Cervical Cancer Vaccine. New York Times. February 17, 2007.
7. Kaisernetwork.org, Public Health & Education - Detroit News Examines Cost of HPV Vaccine Gardasil, March 29, 2007. Available at: http://www.kaisernetwork.org/dailyreports/rep_index.cfm?hint=2&DR_ID=43913
8. Lawrence O. Gostin; Catherine DeAngelis, et al. Mandatory HPV Vaccination: Public Health vs. Private Wealth. JAMA. 2007;297:1921-1923.
9. National Cancer Institute (NCI). What You Need To Know About Cancer of the Cervix. Available at: www.cancer.gov/cancertopics.
10. Moss, Ralph. On Guard-GARDASIL. Available at: http://www.whale.to/vaccine/moss.pdf
11. National Vaccine Information Center (NVIC). Analysis Shows Greater Risk of

GBS Reports When HPV Vaccine is Given with Meningococcal and Other Vaccines. August 15, 2007. Available at: http://www.nvic.org/PressReleases/PR081507HPV.htm

12. Mandated Human Papillomavirus (HPV) Vaccinations? March 27, 2007. Available at: http://www.clcns.com/hpv.htm
13. Palefsky J., Handley J. What Your Doctor May Not Tell You About HPV and Abnormal Pap Smears. Grand Central Publication. May 1, 2002.
14. Moynihan R, Henry D. The Fight Against Disease-Mongering; Generating knowledge for Action. April 2006. Available at: www.diseasemongering.org/downloads/abstracts.pdf
15. Public Health Initiatives. FY08 House 1 Budget Recommendations. Available at: http://www.mass.gov/bb/fy2008h1/dnld08/404_public_health_initiatives.doc.
16. Dailard,Cynthia. The Public Health Promise and Potential Pitfalls Of the World’s First Cervical Cancer Vaccine. Guttmacher Policy Review. Winter 2006

Volume 9, Number 1.

17. Adams, Mike. The Great HPV Vaccine Hoax Exposed. December 19, 2007. Available at: http://www.naturalnews.com/Report_HPV_Vaccine_0.html
18. Hildesheim, A., Herrero, R., Wacholder, S., Rodriguez, A. C., Solomon, D., Bratti, M. C., Schiller, J. T., Gonzalez, P., Dubin, G., Porras, C., Jimenez, S. E., Lowy, D. R., for the Costa Rican HPV Vaccine Trial Group, (2007). Effect of Human Papillomavirus 16/18 L1 Viruslike Particle Vaccine Among Young Women With Preexisting Infection: A Randomized Trial. JAMA 298: 743-753.
19. The One Less Campaign-An expert opinion on Gardasil. February 19, 2008. Available at: http://www.sexloveandmarriage.wordpress.com
20. Sedjo RL, Roe DJ, Abrahamsen M, et al. Vitamin A, carotenoids, and risk of persistent oncogenic human papillomavirus infection. Cancer Epidemiological Biomarkers Prevention 2002;11:876-884.

Children, Adolescents and Mental Health Problems: Psychiatric Drug Cocktails Are not the Answer—Elizabeth Clarke

According to the National Institutes of Mental Health (NIMH), 1 in 10 children and adolescents in the United States suffers from mental illness serious enough to warrant psychiatric treatment (1). The most common diagnoses include Attention Deficit Hyperactivity Disorder (ADHD), Autism Spectrum, Bipolar Disorder, Borderline Personality Disorder, Depression, Eating Disorders, and Schizophrenia (1). The prevalence of these diagnoses has increased markedly in recent years. Nationwide, the diagnosis and pharmaceutical treatment of bipolar disorder, for instance, has increased 40-fold over the last 10 years (2). The prevalence of severe, incapacitating psychiatric illnesses has tripled over the last ten years in the U. S. (3).
That the incidence of these diseases is increasing this rapidly is alarming but what is more concerning from a public health perspective is the widespread overuse and even abuse of psychiatric medications in treating these disorders. Drug-based interventions for psychiatric conditions are flawed and ineffective. These disorders are grounded in psychology, society and culture yet the current intervention approach does not consider the social and behavioral theories of public health.
Indeed, psychiatric drug interventions ignore the underlying psychological, social, and cultural roots of mental health problems in adolescents. Furthermore, pharmacologic treatments fall short in terms of their poor safety, sustainability, and comprehensiveness.
Drug Interventions stigmatize children and adolescents with mental health disorders.
Because pharmaceutical treatments are far from comprehensive, they are not sensitive to the emotions of adolescents and children with mental health disorders. Overlooking mental health patients’ feelings simply makes the problem worse, since many aspects of mental health deal with emotional health (4). Instead of addressing the disorders comprehensively, pharmaceutical interventions effectually label patients as “defective” and in need of drug treatment to remedy their problems. In this way, psychiatric drug interventions stigmatize the plight of children and adolescents who are suffering from mental health problems (4). In fact, recent data from the National Stigma Study-Children (NSS-C) indicates that many parents feel the psychiatric medication itself stigmatizes their children “delays solving ‘real’ behavior-related problems” (5).
Stigmatization of mental illness is proven to decrease an already low quality of life for children and adolescents suffering from mental health problems (6). One study found that people experiencing high degrees of stigmatization were seven to nine times more likely to have low self-esteem than those experiencing low degrees of stigmatization (7). Pharmaceutical treatment of child and adolescent mental health problems encourages stigmatization and is therefore a poor choice for treatment among children and adolescents.
Drug interventions do not empower children and adolescents.
Social cognitive theory emphasizes individual characteristics of self-efficacy, behavioral capability, expectations, and coping and reinforcement, context, and reciprocal determinism as environmental factors in health behavior (8). Children and adolescents who are prescribed psychiatric medications for their mental health problems are effectively being told that they cannot make progress without the pills they are prescribed. This is a tremendously discouraging message to send. Instead of empowering these children and adolescents with self-efficacy, drug treatments alone communicate a general sense of hopelessness and chemical dependency (3, 4). The result is that patients may act less confidently or more defensively, or just avoid interactions with people completely (7).
In many cases, the reality is that physicians are evaluating simplistic and superficial outcomes in lieu of the full psychosocial context in response to treatment (9). Reportedly, drug interventions can also numb patients’ thoughts, emotions, and behaviors (10). This is the reverse of empowerment. By ignoring psychological complexities in prescribing psychiatric medications, physicians are not only ignoring important causes and catalysts for mental health problems, but they are making the illnesses worse.
Pharmaceutical treatments do not account for culture, environment or socioeconomic status.
Drug interventions do not take into account the environment in which the children and adolescents are raised, and therefore ignore important sources and catalysts of mental health conditions. Socioeconomic factors include the culture and opportunities which the affected children and adolescents encounter daily, and these factors must be considered when evaluating both the cause of illness and its treatment. Many children of low socioeconomic status live in abusive households with one or both parents absent and/or abusive most or all of the time (10). Such maltreatment is proven to seriously and dramatically impact the children’s mental health for the worse (11). However, pharmaceutical interventions do not address child abuse and therefore miss a huge cause of the illness.
Evidence from environmental health studies suggests that environmental toxicants are directly involved in adolescent mental health problems (12). Furthermore, the relative concentrations of these toxicants are higher in neighborhoods of low socioeconomic status. This leads to a markedly higher risk of acquiring mental health problems at a chemical level (13). However, this can also be exacerbated in an indirect fashion. The stress experienced during exposure to pollutants can promote anxiety and learned helplessness (13).
Additionally, access to community resources is limited for children and adolescents of low socioeconomic status. Without these resources, the stress of having pollutants in the neighborhood can lead to a greater vulnerability to the environmental toxicants (13). Interventions for children and adolescents should consider socioeconomic status. Drug-based treatments, however, fail to do this.
Even beyond socioeconomic stratification, the contemporary U.S. culture is generally harsh, discouraging, and distracting. Children of all socioeconomic strata are growing up in an increasingly emotionally distant, fast-paced culture (3, 14). The widespread and frequent use of videogames, television, and the internet brings children into close contact with violence, gore, and other disturbing imagery and concepts (15). A meta-analysis review indicates that aggressive behavior, cognition, and affect, as well as cardiovascular arousal and a decrease in empathy are a certain and causal result of videogames (16). Moreover, among children suffering from ADHD, those who play video games are substantially more likely to experience a greater intensity of the disorder than children with ADHD who do not play video games (17).
Television can have damaging effects on adolescent mental health, as well. Eating disorders in particular are correlated with television watching. For instance, adolescent anorexia nervosa and bulimia nervosa incidences have increased directly in response to television viewing (18).
The internet, too, has some profound effects on mental health, especially ADHD, depression, social phobia, and hostility (19). Psychiatric drug interventions fail to address the important role of video games, television, and the internet in child and adolescent mental health disorder progression.
Implications for children and adolescents.
Pharmaceutical interventions present a one-dimensional solution to a complex problem and ultimately fail to address the numerous causes and catalysts of child and adolescent mental health problems. In short, the drug-based interventions simply do not solve the underlying causes of adolescent mental health problems (20). Besides, the current treatments can create more problems than they solve, since the prescribed drugs have a very narrow clinical window (11). Moreover, on many occasions the drugs cannot confer benefit because the diagnosis for which the drugs are indicated is not accurate (3, 11).
Furthermore, the medication has only been tested on adults. Children and adolescent dosing has not been clinically evaluated, so it is not only ineffective but also dangerous to administer psychiatric drugs to this population (21). Many of these drugs have a very narrow clinical window, and a number of deaths have resulted from careless prescribing to children (21).
Additionally, physicians are making a self-admitted uncertain and sketchy diagnosis. There are no blood tests, brain scans, or silver-bullet questions that provide conclusive evidence for diagnosing children and young people. The practitioners have to rely on an inflexible set of diagnostic criteria. This process results in inherent ambiguity and overlap between diagnoses. Adolescents are diagnosed with many different disorders as they grow up (3, 22), which only leads to their own loss of identity, self-efficacy and discouragement regardless of the chemical effects of multiple dosing.
Future Directions.
Given that pharmaceutical treatment of childhood and adolescent mental health is disparagingly ineffective and potentially harmful, research and development of alternative treatment is imperative. Such treatments include exercise, psychotherapy, and group activity. These therapies present safer, more suitable, and more comprehensive solution to issues of psychiatric illness in children and young adults (22, 23, 24, 25, 26).
Exercise in particular has been shown to be an emphatic strategy in preventing and attenuating mental health complaints in children (25, 26). One study found that exercise works on dopamine level balance, which is askew in many mental health disorders (27). Furthermore, physical activity demonstrably improves cognition and performance in children and adolescents (28). Performing well boosts self-efficacy and empowers individuals to succeed.
Psychotherapy has also been shown to improve the mental health of children and adolescents (22). Among children and adolescents with ADHD, parent-child interaction and management training, classroom behavior modification methods, and special educational placement dramatically improve symptoms (29). In adolescents with clinical depression, the evidenced-based technique of interpersonal therapy (IPT) has proven to be an effective solution in a many different contexts (30).
The “Social Empowerment Training and Responsibilities for Students with ADHD (STARS)” intervention uses group concept based peer support, directed dynamic conversation, and participant-initiated creative problem solving to work through mutual difficulties (31). This program has been highly successful in helping children with ADHD cope with their symptoms. Other group activity-based interventions have had dramatic effects as well, including a trial of family-focused therapy for bipolar disorder (32). In this 9-month randomized clinical trial, those receiving the therapy had improved relationships and greater satisfaction with activities, work and recreational activities.
It is clear that these alternative treatments have resounding success in attenuating a diverse range of mental health problems in children and adolescents. From a public health perspective, therefore, future treatment of adolescent and child mental health must include these non-pharmaceutical interventions to be not only successful but also to not be damaging or deleterious.
References
1. National Institutes of Mental Health: Child and Adolescent Mental Health
http://www.nimh.nih.gov/health/topics/child-and-adolescent-mental-health/index.shtml
2. National Institutes of Mental Health: Rates of Bipolar Diagnosis in Youth Rapidly Climbing, Treatment Patterns Similar to Adults
http://www.nimh.nih.gov/science-news/2007/rates-of-bipolar-diagnosis-in-youth-rapidly-climbing-treatment-patterns-similar-to-adults.shtml
3. The New York Times: Troubled Children: A Series
http://nytimes.com/ref/health/troubled-children.html
4. Salovey, P. and Meyer, J.M. Emotional Intelligence (pp 313-320). In: Jenkins, J., Oatley, K., Stein, N. Human Emotions: A Reader. San Francisco, CA: Wiley and Sons, Inc., 1998.
5. Pescosolido BA, Perry BL, Martin JK, McLeod JD, and Jensen PS. Stigmatizing attitudes and beliefs about treatment and psychiatric medications for children with mental illness. Psychiatric Services 2007; 58:613-8.
6. Klassen AF, Miller A, Fine S. Health-related quality of life in children and adolescents who have a diagnosis of attention-deficit/hyperactivity disorder. Pediatrics 2004; 114:541-7.
7. Link BG, Struening EL, Neese-Todd S, Asmussen S, Phelan JC. Stigma as a barrier to recovery: The consequences of stigma for the self-esteem of people with mental illnesses. Psychiatric Services 2001; 52: 1621-6.
8. Edberg, M. Social, Cultural, and Environmental Theories Part I (pp 51-54). In: Essentials of Public Health Behavior: Social and Behavioral Theory in Public Health. Sudbury, MA: Jones and Bartlett Publishers, 2007.
9. Abraham C , Conner M, Norman, P, ed. Understanding and Changing Health Behaviour: From Health Beliefs to Self Regulation (374 pp). New York, NY: Harwood Academic Publishers, 2000.
10. Cicchetti D, Rogosch FA, Sturge-Apple ML. Interactions of child maltreatment and serotonin transporter and monoamine oxidase A polymorphisms: depressive symptomatology among adolescents from low socioeconomic status backgrounds. Developmental Psychopathology 2007; 19: 1161-80.
11. Manning, N. Psychiatric diagnosis under conditions of uncertainty: personality disorder, science and professional legitimacy. Sociology of Health and Illness. 2000; 22: 621-639.
12. Braun JM, Kahn RS, Froehlich T, Auinger P, Lanphear BP. Exposures to Environmental Toxicants and Attention Deficit Hyperactivity Disorder in U.S. Children. Environmental Health Perspectives. 2006; 114: 1904–1909.
13. Gee GC, Payne-Sturges DC. Environmental health disparities: a framework integrating psychosocial and environmental concepts. 2004; 112: 1645-53.
14. K A Dodge. Social-Cognitive Mechanisms in the Development of Conduct Disorder and Depression. Annual Review of Psychology 1993; 44: 559-584.
15. Porter G, Starcevic V. Are video games harmful? Australas Psychiatry. 2007; 15:422-6.
16. Anderson CA. An update on the effects of playing violent video games. Journal of Adolescence: 2004; 27:113-22.
17. Bioulac S, Arfi L, Bouvard MP. Attention deficit/hyperactivity disorder and video games: a comparative study of hyperactive and control children. European psychiatry: 2008; 23:134-41.
18. Guerro-Prado D, Barjau Romero JM, Chinchilla Moreno A. The epidemiology of eating disorders and the influence of mass media: a literature review. Archives of Specialized Psychiatry (Spanish): 2001; 29:403-10.
19. Yen JY, Ko CH, Yen CF, Wu HY, Yang MJ. The comorbid psychiatric symptoms of Internet addiction: attention deficit and hyperactivity disorder (ADHD), depression, social phobia, and hostility. Journal of Adolescent Health: 2007; 41: 93-8.
20. Corrigan, PW. Mental Health Stigma as Social Attribution: Implications for Research Methods and Attitude Change. Clinical Psychology: Science and Practice: 2000; 7: 48–67.
21. Freeman MP, Stoll AL. Mood stabilizer combinations: a review of safety and efficacy. American Journal of Psychiatry: 1998; 155: 12-21.
22. Zazzali JL, Sherbourne C, Hoagwood KE, Greene D, Bigley MF, Sexton TL. The adoption and implementation of an evidence based practice in child and family mental health services organizations. Administration and Policy in Mental Health: 2008; 5: 38-49.
23. Weisz JR, Sandler IN, Durlak JA, Anton BS. Promoting and Protecting Youth Mental Health Through Evidence-Based Prevention and Treatment. American Psychologist: 2005; 60: 628–648.
24. Effects of physical exercise on depression, neuroendocrine stress hormones and physiological fitness in adolescent females with depressive symptoms. Chanudda Nabkasorn, Nobuyuki Miyai, Anek Sootmongkol, Suwanna Junprasert, Hiroichi Yamamoto, Mikio Arita and Kazuhisa Miyashita. The European Journal of Public Health 2006 16(2):179-184.
25. Strong WB, Malina RM, Blimkie CJ, Daniels SR, Dishman RK, Gutin B, Hergenroeder AC, Must A, Nixon PA, Pivarnik JM, Rowland T, Trost S, Trudeau F. Evidence Based Physical Activity for School-age Youth. The Journal of Pediatrics. 2005; 146: 732-737.
26. Burnsa J, Rapee, RM. Adolescent mental health literacy: Young people's knowledge of depression and help seeking. Journal of Adolescence: 2006; 29: 225-239.
27. Tantillo M, Kesick CM, Hynd GW, Dishman RK. The effects of exercise on children with attention-deficit hyperactivity disorder. Med Sci Sports Exerc.: 2002; 34:203-12.
28. Hillman CH, Erickson KI, Kramer AF. Be smart, exercise your heart: exercise effects on brain and cognition. Nat Rev Neurosci. 2008; 9:58-65.
29. Barkley RA. Psychosocial treatments for attention-deficit/hyperactivity disorder in children. J Clin Psychiatry. 2002; 63:36-43.
30. Mufson L, Sills R. Interpersonal Psychotherapy for depressed adolescents (IPT-A): an overview. Nord J Psychiatry. 2006;60(6):431-7.
31. Frame K. The STARS program: social empowerment training for preadolescents with attention deficit hyperactivity disorder (ADHD). J Sch Nurs. 2004; 20:257-61.
32. Miklowitz DJ, Otto MW, Frank E, Reilly-Harrington NA, Kogan JN, Sachs GS, Thase ME, Calabrese JR, Marangell LB, Ostacher MJ, Patel J, Thomas MR, Araga M, Gonzalez JM, Wisniewski SR. Intensive psychosocial intervention enhances functioning in patients with bipolar depression: results from a 9-month randomized controlled trial. Am J Psychiatry. 2007; 164:1340-7.