To Mandate or Not to Mandate: Politics and HPV Vaccination

Between political posturing and pharmaceutical proclamations, the specter of mandatory human papillomavirus (HPV) vaccination has once again been raised, appearing in medical journals as well. Political pundits promote it to procure votes while pharmaceutical companies do so for dollars (with the new double-edged sword of vaccinations for both young males and females). While it is commonly believed that the unsuccessful attempt to mandate the HPV vaccination in Texas was linked financially to interests within the pharmaceutical industry, the governor proclaimed in political debates that his move was a response to an emotional appeal from a victim of cervical cancer. In the midst of whirling political rhetoric, how is the lay public to properly assess this issue without being sucked into the spinning vortex?

There are about forty different types of human papillomavirus that infect the genital mucosa, of which approximately twenty are considered oncogenic. The first quadrivalent HPV vaccine was licensed for use in 2006, but not widely utilized until 2007 when the imprudent move was made to mandate the vaccination for public school students, a move that lacked the empirical foundation to withstand critical opposition. This vaccine covered HPV types 6, 11, 16, and 18—two non-oncogenic and two oncogenic viral types. A second bivalent vaccine entered the market in 2009, covering only the oncogenic types 16 and 18. The vaccines have been preferentially targeted for use in 9 to 11 year-old females (with the vaccination offered up to age 26), but in 2010 the Advisory Committee on Immunization Practices (ACIP) of the CDC stated that the vaccination may be administered to 9 to 26 year-old males as well. Both vaccines have proven to be highly effective in preventing infection-related conditions due to the covered HPV types. The efficacy rate for the prevention of vulvo-vaginal and cervical dysplasia in girls receiving the quadrivalent vaccine was nearly 100%, while that for the bivalent vaccine was 93%. Correspondingly, the vaccine was 89% effective in preventing genital warts and 75% effective in preventing anal dysplasia in boys who received the quadrivalent vaccine.[1] Both have proven to be relatively safe with only minor adverse effects noted, most commonly headache, fever, pain at the injection site, and syncope.

Yet despite the media blitz, voluntary vaccination rates have only reached 32% of potential candidates,[2] a fact that has concerned regulatory agencies and fueled the appeal for mandatory HPV vaccination.[3] In fact, it may also have provided the impetus for recommendations to extend vaccination to young boys. According to the CDC, female-only vaccination is the most cost-effective strategy for reducing the burden on HPV-related conditions since females bear a disproportionate burden of the infection; but “when the female vaccination rate drops below 80%, the vaccination of males might be cost-effective” (italics mine).[4] Increasing the vaccination rates of females, however, is preferred to the additional vaccination of males.[5] But this raises a crucial question: does the effectiveness and safety of the vaccine warrant a mandate?

One common argument for mandatory HPV vaccination made by private individuals[6] as well as the government[7] is that it is analogous to “other mandatory adolescent vaccinations,”[8] but such a claim makes a category mistake. There is a distinct difference between communicable diseases, which are airborne and pose an immediate risk of transmission through casual contact, and sexually transmitted diseases which require intimate contact. Historically, vaccinations for communicable diseases were made compulsory to protect the health of school children, for children cannot attend school without the risk of inadvertently acquiring a communicable disease; the same is not true of sexually transmitted diseases. Moreover, sexually transmitted diseases can be prevented by responsible behaviors; not so with communicable diseases, many of which are most infectious before they are fully manifest.

A second argument for mandatory HPV vaccination concerns the public health threat posed by HPV infections and HPV-related cancers. Indeed, HPV is the most common sexually transmitted disease in the United States with a prevalence of 35% among those aged 14-19 years and an overall prevalence rate of 23%.[9] Yet cervical cancer is diagnosed in approximately 12,000 women each year and accounts for approximately 4,000 deaths per year (an incidence of 2.4/100,000 in 2007 compared to 40.2 for lung cancer, 23.4 for breast cancer, and 14.5 for colorectal cancer).[10] Anal and penile cancers, for which HPV is a causal agent, are considered rare and are diagnosed in about 2,500 and 800 individuals respectively each year.[11] And about 25-35% of oropharyngeal cancers are attributable to HPV infections accounting for another 7,400 cases yearly.[12] While for any individual, a diagnosis of cancer is a significant event, from a public health perspective, these numbers do not justify categorizing HPV as a major public health threat and invalidate this argument for mandating the vaccine.

Both vaccines cover HPV-16 and -18, two oncogenic viral types that account for 70% of cervical cancers worldwide. However, statistics from the National Health and Nutrition Examination Survey (NHANES) have revealed that the prevalence of these viruses among U.S. women is low. HPV types 6, 11, 16, and 18 were detected in only 3.4% of female participants, HPV-6 in 1.3%, HPV-11 in 0.1%, HPV-16 in 1.5%, and HPV-18 in 0.8%.[13] Hence, while these viral types are important worldwide, they are not the primary etiologic factor for cervical cancer among U.S. women.[14] Moreover, while the vaccines have proven to be effective in preventing HPV infection with these viruses, to date, there is no evidence from clinical trials demonstrating that vaccination actually prevents invasive cervical cancer, despite the claims of the government and media to that effect.

Another crucial fact rarely mentioned in discussions of these vaccines is the transient nature of the viruses, especially among adolescents. The average duration of infection is eight months with spontaneous resolution of non-oncogenic viruses occurring in nearly 100% of infected individuals within one year.[15] When oncogenic viral infections are considered, 70% resolve spontaneously within one year and 91% will resolve within two years.[16] Even most HPV-16 infections are undetectable two years after initial exposure.[17] Resolution of the viral infections also entails the resolution of any virally-induced conditions. This transience is a relatively new discovery that has significantly altered the management of pap smears and cervical abnormalities with new guidelines established by the American College of Obstetricians and Gynecologists in 2009. Failure to take transience into consideration in discussions of HPV vaccination ignores essential evidence required for the decision-making process, information that weighs against mandatory vaccination. Moreover, when such facts are eliminated from consent, as they frequently are, informed consent fails to be informed.

The fact that many public health organizations have endorsed HPV vaccination for young women is often used to argue for mandatory vaccination, but endorsement does not necessitate a mandate. Such reasoning is otherwise referred to as the “fact-value” fallacy: the fact of endorsement does not make vaccination obligatory or mandatory; many other factors deserve consideration, not the least of which is cost. Historically, this is the most costly vaccine developed for use by the general public; the cost of the vaccine to the patient, including costs of administration, is approximately $525 for three doses. Yet it is a cost which many would like to add to our bloated and unaffordable compendium of essential healthcare items.

The fundamental issue surrounding the mandate of the HPV vaccine, therefore, is distributive justice in healthcare. Given that these vaccines cover only two of the twenty or more oncogenic viruses infecting the genital tract, which in turn account for only approximately 2% of all oncogenic viral infections in the U.S., the pap smear (not to mention abstinence) is a more cost-effective means of preventing cervical cancer than vaccination. When there are millions of people without healthcare in the United States, can we really afford to vaccinate all of our adolescents in order to possibly prevent 2,800 deaths (that 70% related to HPV-16 and -18) 40 years from now?

A mandate is not an innocuous undertaking: it constitutes a violation of autonomy and informed consent. While such violations may be allowed in circumstances in which there is a significant threat to public health, the evidence surrounding HPV infections neither warrants nor justifies such a mandate.

It seems rather curious that the promoters of women’s reproductive rights (including their right to privacy with regard to sexuality and reproduction) now propose to invoke governmental mandates to regulate one aspect of those rights. Such a mandate would shift paternalism—so loudly decried—from the physician to the state. Why would anyone then consider a mandate? While purely speculative, there can be little doubt that mandatory vaccination of U.S. young women would serve to subsidize its use in developing countries where pap smears are not available, where HPV-16 and -18 are more prevalent, and consequently where the vaccine has far greater efficacy but is unaffordable.

These comments should not be taken as a dismissal of the value of the vaccine, but only of the political move to mandate its administration. The development of the vaccine is a great benefit for third world countries with limited diagnostic resources and it holds the promise of serving as a catalyst for development of a comprehensive vaccine that will prevent all HPV infections. But until that time its effectiveness will necessarily be limited.

Ultimately, arguments in favor of state or federal mandates for HPV vaccination lack empirical warrant. There are indeed confirmed benefits of HPV vaccination, but issues of low prevalence, cost, and distributive justice weigh powerfully against a mandate. Some have claimed that healthcare policy should be driven by science, but because medicine is a moral endeavor, healthcare policy must be driven by more than science: ethics are absolutely essential. The fact that we can do something does not necessarily mean that we should or must. Furthermore, human knowledge, by nature, is always transient, fallible, and incomplete, as is our science. History, even the recent history of medicine, is evidence that the science of today is the error of tomorrow. Political knowledge is no less fallible. It is therefore time to return healthcare decisions to their rightful owners: patients in consultation with their physicians.

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References

[1] Centers for Disease Control and Prevention, “HPV Information for Clinicians,” http://www.cdc.gov/std/HPV/STDFact-HPV-vaccine-hcp.htm (accessed April 30, 2012).

[2] Centers for Disease Control and Prevention, “National Survey Shows HPV Vaccine Rates Trail Other Teen Vaccines,” http://www.cdc.gov/media/releases/2011/p0825_hpv_vaccine.html (accessed April 30, 2012).

[3] Lawrence O. Gostin, “Mandatory HPV Vaccination and the Political Debate,” The Journal of the American Medical Association 306, no.15 (October 19, 2011), 1699-1700.

[4] Centers for Disease Control and Prevention, “FDA Licensure of Quadrivalent Human Papilloma Virus Vaccine (HPV4, Gardasil) for Use in Males and Guidance from the Advisory Committee on Immunization Practices (AC IP),” http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5920a5.htm (accessed April 30, 2012).

[5] Ibid.

[6] Gostin, “Mandatory HPV Vaccination,” 1700.

[7] Centers for Disease Control and Prevention, “2011 Recommendations for Immunization for Children from Ages 7 through 18 Years Old,” http://www.cdc.gov/vaccines/who/teens/downloads/parent-version-schedule-7-18yrs.pdf (accessed December 7, 2011).

[8] Gostin, “Mandatory HPV Vaccination,” 1699.

[9] Centers for Disease Control and Prevention, “2009 Sexually Transmitted Disease Surveillance: Other Sexually Transmitted Diseases,” http://www.cdc.gov/std/stats09/other.htm#HPV (accessed December 7, 2011).

[10] Centers for Disease Control and Prevention, “Cancer Statistics,” http://www.cdc.gov/Features/dsCancerStatistics/ (accessed January 25, 2012).

[11] Centers for Disease Control and Prevention, “HPV-Associated Head and Neck (Oral Cavity and Oropharyngeal) Cancer Rates by Race and Ethnicity,” http://www.cdc.gov/cancer/hpv/statistics/headneck.htm (accessed December 7, 2011).

[12] Centers for Disease Control and Prevention, “HPV-Associated Anal Cancer Rates by Race and Ethnicity,” http://www.cdc.gov/cancer/hpv/statistics/anal.htm (accessed December 7, 2011).

[13] Centers for Disease Control and Prevention, “2009 Sexually Transmitted Disease Surveillance: Other Sexually Transmitted Diseases,” http://www.cdc.gov/std/stats09/other.htm#HPV (accessed December 7, 2011).

[14] Eileen F. Dunne and others, “Prevalence of HPV Infection among Females in the United States,” The Journal of the American Medical Association 297, no. 8 (2007), http://jama.ama-assn.org/content/297/8/813.full.

[15] Centers for Disease Control and Prevention, “Sexually Transmitted Diseases (STD s): HPV Information for Clinicians – Fact Sheet,” http://www.cdc.gov/std/HPV/STDFact-HPV-vaccine-hcp.htm (accessed April 30, 2012).

[16] Ibid.

[17] Ibid.