HPV is the number one sexually transmitted disease in the U.S. The disease which used to be thought of as innocuous but annoying, which causes the growth of genital warts and other anomalies, has since been linked to abnormal tissue growth in the cervical area causing dysplasia and potentially cervical cancer among millions of women. The viral infection and more specifically HPV viral infection with one of only a few of more than forty forms of HPV is the most common cause of cervical cancer among women. (Centers for Disease Control and Prevention (CDC), 2010) Since the early days of the discovery of this link researchers have been working toward creating an effective immunization that would protect women from contracting at least a few of the most serious forms of the disease. The catch is, like any other immunization, really the only viable protection from viral infections which the medical community has had very little luck treating after the fact, is that the immunization's efficacy is best when it is given far before any risk of exposure occurs. Because HPV is primarily a sexually transmitted disease this means giving the vaccination to young girls prior to their first sexual experience. (Young MD MPH, 2008) "HPV infects approximately 20 million people in the United States with 6.2 million new cases each year. There is no treatment for HPV, only treatment for related health problems. (National Conference of State Legislators (NCSL), 2010) Yet, it would be negligent to mandate this vaccine and make school admittance contingent upon recieving it. Primarily because it would place an undue psychological and economic burden on families. (Brewer & Fazekas, 2007) and Secondarily because there is simply not enough long-term data regarding its efficacy and potential risks. This paper will argue against the mandate of the HPV vaccination for the above two reasons. (Young MD MPH, 2008) (National Conference of State Legislators (NCSL), 2010)
Undue Psychological and Economic Burden
As any thinking person might be aware this is a tenuous ethical and moral issue, due in large part to the same ideologies that surround sex education and its allowable extent in the public school system. There are those who believe that certain exposures to information will encourage young people to have sex before they are ready to do so. Though this is not the opinion of this researcher the contention does exist and many individuals dislike the idea of mandating information or medical treatment that could give young people de facto permission to have sex. The same can be said about access to prophylactics as well as other forms of pregnancy and disease prevention surrounding sexual activity. Another ethical and moral dilemma, despite the reported efficacy of the HPV vaccination, is that it is gender specific as only girls suffer from the potential risks of cervical cancer from HPV infection. (Saslow, et al., 2007) The vaccination is also relatively expensive in its present form, running about $360 for the three doses in addition to the three physician visits required to administer it. HPV statistics in the U.S. are far better than in many other nations in large part due to treatment and early screening with traditional methods, i.e. Papanicolaou (PAP) exams in the U.S. is much more wide spread and effective, causing the U.S. numbers to be much smaller than those in many other nations as early detection often creates a very treatable condition. (National Conference of State Legislators (NCSL), 2010) In the NCSL report it is also noted that there is currently only one (branded) HPV vaccination on the market (Gardasil: Merck) and that it is effective against HPV 6, 11, 16 and 18, which is reported to cause about 70% of all cervical cancer causing cases and about 90% of all HPV infections that cause genital warts. Currently the vaccination is recommended by the ACIP for administration to girls aged 11 and 12. A second immunization that focuses on HPV 16 and 18 (Cervarix: GlaxoSmithKline) is still awaiting FDA approval. (National Conference of State Legislators (NCSL), 2010)
Risks Outweigh Burden
According to the NCSL, cervical cancer is the second leading cause of cancer death among women in the world. Also in the U.S. It is noted that almost 10 thousand women every year are diagnosed with cervical cancer and about 3, 700 women die annually as a result of cervical cancer. (National Conference of State Legislators (NCSL), 2010) Regardless of its severity or affect on society and individuals this does not warrant premature mandating of the vaccination and mandating the vaccination for school attendance would place an undue burden on families.
The ethical issues within families is an essential aspect of the debate as for some the mandate could place a psychological burden if they are opposed to giving the drug to their daughters for moral or religious reasons. Financing is another concern: if states make the vaccine mandatory, they must also address funding issues, including for Medicaid and SCHIP coverage and youth who are uninsured, and whether to require coverage by insurance plans. This has caused some to push for further discussion and debate about whether or not to require the vaccine. (National Conference of State Legislators (NCSL), 2010) Though it has been made clear by the CDC that the HPV immunization (Gardasil) is available through federal funding programs that will cover low income children who qualify for Medicaid, some uninsured children and all Native American children, Vaccines for Children (VFC) this funding is limited and will clearly not be inclusive. This will place an undue burden on families with girls going into the 6th grade, if mandates are legislated in states. (National Conference of State Legislators (NCSL), 2010) There is also a clear sense that many people are resistant to mandating the vaccination due to a perceived limitation of risk for their child and this mindset needs to be altered for a mandate to be effective, especially if mandates include primary opt out options that are secondary to the overall opt out options of existing immunizations and there require much less effort. (Brewer & Fazekas, 2007, p. 107)
Long-Term Data is Still Needed
The American Cancer Society, and several other health organizations have developed a series of recommendations for the implementation for the HPV immunization, (Saslow, et al., 2007) yet it is clear that more discussion and debate needs to take place before the vaccination is mandated by any state as a compulsory immunization for school attendance. Especially considering that the first legislation associated with mandating the vaccination was introduced in Michigan only 3 months after the FDA approved the drug. (Colgrove, 2006, p. 2389) The main sources for the recommendation of a mandate, the ACIP and CDC are not currently ready to say that the data avaialbe is adequate for a mandate and both recommend aditional postintrodduction testing. (Young MD MPH, 2008)
The NCSL also notes that the ACIP simply offers recommendation and that state legislatures are usually ultimately responsible for the mandate of any new vaccination mandate on the compulsory schedule and though some states allow their State Health Department to change vaccination requirements legislatures still need to support this with passed legislation and funding procedures. (National Conference of State Legislators (NCSL), 2010)
Some people who support availability of the vaccine do not support a school mandate, citing concerns about the drug's cost, safety, and parents' rights to refuse. Still others may have moral objections related to a vaccine mandate for a sexually transmitted disease. (National Conference of State Legislators (NCSL), 2010)
The resulting situation is one where the marketing and hype for the very expensive and likely extremely useful drug has created the ideation that the drug has no risks, even though long-term data is not available and from the perspective of a mandate has not been proven without a doubt. The Association of Immunization Managers (AIM) and the Association of State and Territorial Health Officials (ASTHO) contend that to adequately support a vaccination mandate more time and events must pass for a number of reasons. In many ways the drug companies and legislators have jumped the gun, thinking that the drug simply because it has been FDA approved is safe and as effective as hoped.
Efficacy Has Been Proven
Some authors and non-experts contend that the efficacy and safety of the drug have been proven by the process of FDA approval, but there are many examples of situations where large scale use has proven otherwise. (Colgrove, 2006) " Postmarketing surveillance would yield more information on a new vaccine's safety profile in a wider population. A school mandate for the HPV vaccine falls short of these criteria largely due to the short implementation time since FDA approval." (Young MD MPH, 2008)
The efficacy of the drug as well as its safety can only be proven by an "adequate implementation period." This time would allow many of the kinks to be worked out, including but not limited to proof of safety and effectiveness in a larger popualtion, as thedrug…