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
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
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.
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
- Center for Control Disease and Prevention (CDC). HPV Vaccine What You Need To Know [press release]. February 2, 2007.
- Parkin DM. The global health burden of infection-associated cancers in the year 2002. Int J Cancer. 2006;118:3030-3044.
- Merck. GARDASIL [Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine], 2006. www.gardasil.com
- Siers-Poisson, Judith. Politics and PR of Cervical Cancer, 2007. Available at http://www.prwatch.org/node/6186.
- Berger, Sam. Mandatory Opposition. Center for American Progress, March 12, 2007. Available at: http://www.americanprogress.org/issues/2007/03/hpv.html
- Saul S, Pollack A. Furor on rush to require Cervical Cancer Vaccine. New York Times. February 17, 2007.
- 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
O. Gostin; Catherine DeAngelis, et al. Mandatory HPV Vaccination: Public Health vs. Private Wealth. JAMA. 2007;297:1921-1923. Lawrence
- National Cancer Institute (NCI). What You Need To Know About Cancer of the Cervix. Available at: www.cancer.gov/cancertopics.
- Moss, Ralph. On Guard-GARDASIL. Available at: http://www.whale.to/vaccine/moss.pdf
(NVIC). Analysis Shows Greater Risk of National Vaccine Information Center
GBS Reports When HPV Vaccine is Given with Meningococcal and Other Vaccines. August 15, 2007. Available at: http://www.nvic.org/PressReleases/PR081507HPV.htm
- Mandated Human Papillomavirus (HPV) Vaccinations? March 27, 2007. Available at: http://www.clcns.com/hpv.htm
- Palefsky J., Handley J. What Your Doctor May Not Tell You About HPV and Abnormal Pap Smears. Grand Central Publication. May 1, 2002.
- Moynihan R, Henry D. The Fight Against Disease-Mongering; Generating knowledge for Action. April 2006. Available at: www.diseasemongering.org/downloads/abstracts.pdf
- Public Health Initiatives. FY08 House 1 Budget Recommendations. Available at: http://www.mass.gov/bb/fy2008h1/dnld08/404_public_health_initiatives.doc.
- 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.
- Adams, Mike. The Great HPV Vaccine Hoax Exposed. December 19, 2007. Available at: http://www.naturalnews.com/Report_HPV_Vaccine_0.html
- 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.
- The One Less Campaign-An expert opinion on Gardasil. February 19, 2008. Available at: http://www.sexloveandmarriage.wordpress.com
- 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.