A mandate in Texas: the story of a compulsory vaccination and what it means.

ON February 2, Texas became the first state to require that young girls be vaccinated against some sexually transmitted viruses. This happened when Gov. Rick Perry issued an executive order requiring that students receive a new vaccine before entering the sixth grade. Perry's order has met with criticism from state legislators who object to his unilateral action, medical groups that welcome the breakthrough vaccine but oppose a mandate, and parents who believe that such coercion usurps their authority. The vaccine's manufacturer is aggressively lobbying other state legislatures to back mandates, and legislation to require the new vaccine is pending in over a dozen states.

Last June, the Food and Drug Administration approved Merck & Co.'s Gardasil vaccine for females aged 9 to 26. When administered to girls before they become sexually active, the vaccine can protect against two of the strains of the human papillomavirus (HPV) that cause about 70 percent of cervical cancers. Within a few weeks of the approval, the vaccine was added to the federal list of recommended routine immunizations for eleven- and twelve-year-old girls. The duration of immunity for the three-dose vaccine series, at a cost of about $360, is not yet known. The federal, means-tested Vaccines for Children program will now include the HPV vaccine, and insurance companies are expected to begin covering its costs.

There is little controversy over the recommendation that the vaccine be broadly used. HPV is the most common sexually transmitted infection, with about half of those who are sexually active carrying it at some point in their lives and about 6.2 million infected annually. The number of sexual partners is the most important risk factor for genital HPV infection. There are no treatments to cure HPV infections, but most are cleared by the immune system, with 90 percent disappearing within two years. Some infections do persist, causing genital warts, cancers of the cervix, and other types of cancer. Each year, over 9,000 new cases of cervical cancer are diagnosed, and the disease kills 3,700 women. Routine Pap tests have dramatically reduced the incidence of cervical cancers over the past 50 years, and it is recommended that even those immunized with the new vaccine continue to be tested, as the vaccine doesn't guard against eleven other high-risk strains of HPV that cause cancer.

Governor Perry recognized that "the newly approved HPV vaccine is a great advance in the protection of women's health" in a "whereas" clause on the way to his "therefore" order that rules be adopted to "mandate the age appropriate vaccination of all female children for HPV prior to admission to the sixth grade." In turning a federal recommendation into a state mandate, Perry has thrilled the vaccine manufacturer while acting against the balance of medical opinion. And critics object to an opt-out provision that puts the onus on parents to file an affidavit seeking approval of their objection.

The American College of Pediatricians opposes requiring the vaccination for school attendance, saying that such a mandate would represent a "serious, precedent-setting action that trespasses on the rights of parents to make medical decisions for their children as well as on the rights of the children to attend school." The chairman of the American Academy of Pediatrics Committee on Infectious Diseases, Dr. Joseph A. Bocchini, believes a vaccine mandate is premature. "I think it's too early," he said. "This is a new vaccine. It would be wise to wait until we have additional information about the safety of the vaccine." The Texas Medical Association also opposes the mandate, expressing concerns over liability and costs.

Mandatory-education laws create a responsibility to make sure that children are vaccinated against contagious diseases they might be exposed to at school. Now states are considering compelling vaccination in the name of a broad public good, even though the disease in question would not be spread at schools.

Dr. Jon Abramson, the chairman of the Advisory Committee on Immunization Practices of the Centers for Disease Control, explains that protecting children against a virus that is spread by sexual activity is different from preventing the spread of measles. Abramson believes that mandating the HPV vaccine "is a much harder case to make, because you're not going to spread it in a school unless you're doing something you're not supposed to be doing in school." Non-vaccinated students would pose no risk to others while at school.

Texas state senator Glenn Hegar has introduced legislation to reverse Governor Perry's order on the grounds that research trials are still underway and "such mandates take away parents' rights to make medical decisions for their children and usurp parental authority." Twenty-six of 31 state senators believe the governor has usurped legislative authority too, and are calling on him to rescind the executive order. Perry stands by the order, but the rising controversy has discouraged other supporters of mandates.

The Washington Post recently reported that Virginia and 17 other states are considering the vaccine requirement "at the urging of New Jersey-based pharmaceutical giant Merck & Co.... [which] stands to earn hundreds of millions of dollars annually on Gardasil, according to Wall Street estimates." Public-health organizations have joined Merck in urging that the vaccine be made available in public clinics and encouraging its coverage by private insurers, but they don't support Merck's push for a school requirement.

There were 210 cases of cervical cancer in Maryland last year. Democratic state senator Delores Kelley introduced a bill to require the HPV vaccine for sixth-grade girls. Following complaints from parents and recent non-compliance problems with current mandated vaccinations, Kelley has withdrawn her bill (though she has spoken openly of reintroducing it next session). She explains that she was unaware of Merck & Co.'s lobbying efforts, and that she learned about the new HPV vaccine through a nonpartisan group of female legislators called Women in Government. More than half of its listed supporters are pharmaceutical manufacturers or other health-related companies. Women in Government is spearheading the campaign to mandate the HPV vaccine through school requirements, and some watchdog groups question the support it receives from Merck & Co. "It's not the vaccine community pushing for this," explains the director of the National Network for Immunization Information. Governor Perry's critics point to his own connection with Gardasil's manufacturer: His former chief of staff is a lobbyist for Merck & Co. in Texas.

The profit motive of a company can coincide with public-health interests, but the case for an HPV-vaccine mandate has not been made. The new vaccine does not prevent cervical cancer, but is a welcome protection against some strains of HPV. It is already available to parents who can decide whether it is appropriate for their young daughters. In substituting his judgment for theirs, Governor Perry has attempted to intrude upon their prerogatives and responsibilities. He has also substituted his own judgment for expert medical opinion. State officials who follow his lead won't enjoy immunity from the firestorm of criticism they will rightly earn.