Gardasil may be mandatory for girls as young as eleven

Visions of a virus spreading from child to child in an elementary school classroom make it easy for state officials to require kids to be vaccinated against measles or chicken pox. A mandatory vaccine for girls against some strains of the human papillomavirus (HPV) is proving to be a tougher sell in statehouses around the country. In June, the Food and Drug Administration approved Merck & Co.'s Gardasil vaccine for girls and women ages nine to 26. A government advisory panel later recommended that all 11- and 12-year-old girls get the series of shots. Gardasil is administered in three $120 doses over a period of six months and wards off four of the dozens of strains of HPV. The Centers for Disease Control and Prevention reports that 6.2 million US citizens get HPV each year, making it among the most common sexually transmitted diseases. People with HPV rarely exhibit symptoms, but it can lead to genital warts and cervical cancer. While men are also infected with HPV, cervical cancer is the most serious consequence, and Gardasil is recommended only for women and girls. According to estimates by the Centers for Disease Control and Prevention, at least 80 percent of women will have contracted HPV by age 50, but the majority of cases do not turn into cancer. Some types of HPV can cause a woman's cervical cells to change, but in most cases it's self-limiting, which means that the HPV disappears on its own and the cervical cells return to normal. However, when HPV lingers, the continued cell changes can lead to cancer. Dr. Richard Schlegel, whose research helped lead to the development of Gardasil, said on Jan. 17, that "the great majority of HPV infections resolve spontaneously within one year. Only a small percentage of women, much less than one percent, become persistently infected by the virus and have an increased chance of developing cervical cancer." The American Cancer Society estimates that cervical cancer will be diagnosed in 9,700 women nationwide this year and that 3,700 will die from it. In clinical trials, Gardasil prevented infection from two of the HPV strains that cause over 50 percent of cervical cancers, but it does not protect against most types of HPV and it won't prevent all cases of cervical cancer. It also does not prevent all genital warts, and it won't work against other sexually transmitted diseases. It's so new, Dr. Ruth Shaber, Kaiser's director of women's health for Northern California said, that no one knows how long the vaccine is effective. Initial studies didn't find any serious side effects from Gardasil, but there's a possibility that side effects could emerge as the vaccine is more widely used. A proposal filed in Michigan in September to make Gardasil mandatory was narrowly defeated last month amid concerns from some lawmakers that the mandate would intrude too far into families' lives, even though parents would have been able to decline the vaccine. A representative of the committee that studies infectious diseases for the American Academy of Pediatrics said it's premature for states to mandate the vaccination, but recently proposals have been made in 12 states. Of the states proposing a mandate, all but Mississippi would allow families to opt out of the vaccine, either through existing laws addressing religious and philosophical objections or through clauses in the proposals. In Texas, for example, a parent would have to file an affidavit stating that he or she objected to the vaccine for religious or philosophical reasons. Virginia could become one of the first states to require parents to either get their middle-school daughters vaccinated or apply for an exemption. Del. Phillip Hamilton, (R-Newport News) has introduced a bill, scheduled to be reviewed on Jan. 23, that would add Gardasil to the list of immunizations needed for females' school attendance. Hamilton said pharmaceutical company representatives approached him about submitting the bill, probably because he chairs the House Committee on Health, Welfare and Institutions. Drug companies have been among the largest contributors to Hamilton's election campaigns. Under Hamilton's bill, which would take effect in September 2008. the first dose of the vaccine series would have to be administered to a girl before she entered middle school. The state proposals to add Gardasil to the mandatory list of shots young girls must receive to attend school has sparked a debate over the intersection of sex, public health and parental rights. Groups opposing government-mandated vaccines have voiced opposition, as have religious conservatives who fear that giving it to young girls will encourage promiscuity. Barbara Loe Fisher, president of a Virginia-based organization called the National Vaccine Information Center, said that group was established to help prevent injuries from vaccines and to make sure parents are fully informed about vaccinations. According to the organization, parents, not legislative bodies, generally should make decisions about their children's health. Fisher said she thinks Gardasil differs from vaccines that protect against diseases such as whooping cough and measles in that HPV is not "easily transmittable" in a school environment. Some Michigan legislators raised the same objection when it was proposed that Gardasil be mandatory in the state. They said Gardasil did not hold the same urgency as a vaccine against diseases that can spread quickly from more casual contact.