Public Health vs Private Wealth
By any measure, genital human papillomavirus (HPV) infection and HPV-associated cervical cancer are significant national and global public health concerns. An estimated 11 000 newly diagnosed cases of cervical cancer occur annually in the United States, resulting in 3700 deaths.1 Globally, an estimated 493 000 new cervical cancer cases occur each year, with 274 000 deaths; more than 80% of cervical cancer deaths worldwide occur in developing countries.2
Human papillomavirus is the most common sexually transmitted infection in the United States, with an estimated 6.2 million individuals newly infected annually.3 Data from the National Health and Nutrition Examination Survey revealed a 26.8% overall HPV prevalence among US girls and women, with increasing prevalence each year for ages 14 to 24 years (44.8% for ages 20-24 years) followed by a gradual decline in prevalence through age 59 years (19.6% for ages 50-59 years).4 Although infection with high-risk HPV types is necessary for the development of cervical cancer (detected in 99% of cervical cancers),5 high-risk types 16 and 18 have a relatively low prevalence (3.4% of all HPV infections),4 and not all women who are infected with high-risk HPV types will develop cervical cancer. Approximately 90% of women with new HPV infections clear the infection within 2 years.6
In June 2006, the US Food and Drug Administration (FDA) licensed a prophylactic quadrivalent HPV vaccine against types 6, 11, 16, and 18 for use among girls and women aged 9 to 26 years.7 The FDA approval is conditional on manufacturer assurances concerning ongoing safety and efficacy studies.8 The Centers for Disease Control and Prevention Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination of girls aged 11 to 12 years with 3 doses of quadrivalent HPV vaccine; the vaccination series can be started as young as age 9 years.9 ACIP also recommends “catch-up” vaccination for unvaccinated girls and women aged 13 to 26 years.9
Clinical trials among 16- to 26-year-olds show that the quadrivalent HPV vaccine is almost 100% effective in preventing infection and disease associated with HPV types included in the vaccine.10 Studies show that the vaccine is safe and immunogenic for girls aged 9 to 15 years for at least a short term, but efficacy among this age group has not been evaluated. For those older than 15 years, the vaccine provides protection for at least 5 years, and follow-up studies are under way to determine the duration of protection.9 A bivalent vaccine against HPV types 16 and 18 also has been shown to be highly immunogenic and safe for up to 4.5 years, although it is not yet licensed.11
Earlier this year, Texas (by executive order) and Virginia made quadrivalent HPV vaccine mandatory for girls entering sixth grade. However, the Texas legislature recently voted to overturn the governor’s order and Virginia granted parents generous “opt-out” provisions.12 Nearly 20 additional states are considering similar legislation,13 and some medical experts in Europe are calling for mandatory HPV vaccination.14 Routine use of the quadrivalent HPV vaccine undoubtedly is beneficial to the public’s health, as it is likely to reduce the incidence of cervical cancers. However, the rush to make HPV vaccination mandatory in school-aged girls presents ethical concerns and is likely to be counterproductive.