Background: Human papillomavirus (HPV) is a sexually transmitted virus that frequently infects both men and women. Various strains of the virus have been implicated as the primary cause of cervical, vaginal and vulvar cancer in women, as well as genital warts in both sexes. In 2006, two pharmaceutical firms won FDA approval for their vaccines targeting some of the cancer-causing HPV strains. We have been administering one of the vaccines, Gardisil, for several years. (The other brand is Cervarix.) These vaccines were proven to be effective in reducing the occurrence of precancerous lesions of the cervix and therefore it is believed, but not yet proven, that they will produce a long-term reduction in the occurrence of actual cervical cancers. Moreover, based upon newly released data, the FDA this week approved these vaccines for use in prevention of vulvar and vaginal cancers.
The Articles and Issue: In the August 21, 2008 edition of the New England Journal of Medicine, the authors of an article (Health and Economic Implications of HPV Vaccination in the United States, by Jane J. Kim, Ph.D., and Sue J. Goldie, M.D., M.P.H.) and an accompanying editorial (Human Papillomavirus Vaccination — Reasons for Caution by Charlotte J. Haug, M.D., Ph.D.) explored the public policy implications of wide-scale vaccination programs especially with regard to their cost-benefit. They emphasized that “the real impact of HPV vaccination on cervical cancer will not be observable for decades.” Consequently, they were generally unenthusiastic if not opposed to the widespread or mandatory vaccination of preadolescent girls. A number of our members expressed concern that these articles, especially as reported in the Boston Globe, indicated that their daughters should not be immunized with these vaccines.
Our View: The FDA approved the HPV vaccines two years ago because of excellent data that they reduce the occurrence of the precancerous cervical lesions (called dysplasia) that are known to progress to cervical cancer if left untreated. The FDA’s expectation, with which we concur, is that these vaccines will reduce the occurrence of cervical cancer a decade or two from now, because that is the biological lag time required for cancer to develop from chronic HPV infection. These vaccines have good safety profiles, comparable to other widely used vaccines. Treatment for cervical and vaginal dysplasia is difficult, often painful, and disruptive. Dr. Kanner and Dr. Isselbacher believe that the known benefits of reduced precancerous lesions and the high expectation of reduced risk of cervical, vaginal and vulvar cancers in the coming decades, warrant offering these HPV vaccines to the young women in our practice approaching sexual maturity.