Few doctors, parents or medical ethicists would dispute the astounding potential of the new human papilloma virus vaccine -- it protects against infections that cause 70% of all cervical cancer and most genital warts.
"We use 'breakthrough' way too often, but this is a breakthrough," says Dr. Bradley Monk, an associate professor of gynecologic oncology at UC Irvine School of Medicine. "We are unbelievably enthusiastic to have a vaccine that prevents you from getting cancer."
But should it be mandatory?
In December, California Assemblywoman Sally Lieber (D-Mountain View) introduced a bill that would require girls entering sixth grade to receive the three standard doses of the HPV vaccine. Although state law permits parents to receive an exemption to required immunizations for medical, religious or personal reasons, the bill aims to ensure that most girls are vaccinated before they become sexually active. Similar bills have been introduced in 16 other states and the District of Columbia.
"Requiring vaccinations against a number of diseases for school enrollment gives us the best chance of controlling preventable diseases in society," Lieber says. "Young people deserve to be protected against these diseases."
Reaction to the bills has varied. Evangelical groups have strongly criticized the proposed mandates. Focus on the Family says such measures would violate parents' rights, although the group adds that the vaccine should be available for those who want it. An editorial in the Washington Post said a mandatory vaccine would save lives, while a Wall Street Journal editorial in July labeled the proposals coercion.
It is too early to tell how many of the bills will be approved. In Maryland, the chief sponsor of an HPV bill that appeared to have strong legislative backing withdrew the bill last week following criticism from parents and groups opposed to the legislation. In California, the bill introduced by Lieber has not been assigned to a committee. Lieber's office says that several organizations, including the NAACP, have registered their support.
Nor is it clear how many parents would favor mandating the HPV vaccine, although many appear to want their daughters vaccinated. In a recent phone survey of 522 parents in California whose daughters would be eligible for the vaccine, UC Berkeley public health researchers found that 75% would probably opt for the vaccine.
Those who favor mandating the vaccine point out that cervical cancer will strike about 11,150 women in the U.S. this year and claim an estimated 3,670 lives. (Globally, it is the second most-common cancer among women, according to the World Health Organization.) In short, they say, the vaccine will save lives.
Critics of these legislative efforts have a broad range of reasons for their objections. Some say a compulsory vaccination would tread on the value of abstinence before marriage that they instill in their children. Others fear that the vaccine might encourage promiscuity if youth view the vaccine as a talisman against all sexually transmitted diseases. And some doubt vaccine safety, in general.
The debate highlights the balance between government's obligation to safeguard the health of its people and the rights of individuals to make their own decisions about matters affecting their health and their children's health.
All vaccine mandates pose this dilemma. But the question of an HPV vaccine presents more medical and ethical wrinkles.
"School-based laws began in the 19th century, at about the same time as mandatory education laws," says James Colgrove, a medical historian at the Columbia University Mailman School of Public Health who recently wrote an article for the New England Journal of Medicine about the ethics and politics of HPV vaccination. "People realized that schools were breeding grounds for illness."
Because HPV is not spread through the germ incubator of the classroom, a mandatory vaccine would lack that rationale. Further, for the first time, vaccination policies would affect only one gender. "With a compulsory HPV vaccination, we really are kind of getting into a different territory," Colgrove says.
The FDA approved the vaccine, Gardasil, in June 2006. An advisory committee to the Centers for Disease Control and Prevention recommended that girls receive the vaccine at ages 11 or 12, and that it be given to girls and women through age 26 who have not received it. The vaccine is most effective if given before a girl becomes sexually active. (Women who have been vaccinated should still undergo routine cervical cancer screening.)
Public health experts say that most teenagers have sex by the time they finish high school. The CDC's National Survey of Family Growth, conducted in 2002, shows that 69% of 18- to 19-year-old women, and 64% of men in that age group, have had sex. Further, HPV is the most common sexually transmitted disease, with about 6.2 million new infections in the U.S. each year; most sexually active women become infected by age 50. (Fortunately, most of those infections resolve themselves. But some go on to cause cervical cancer.) A school-linked mandate for HPV vaccination would be an efficient and effective way to protect the public from widespread infection.
Dr. Richard Zimmerman, who recently wrote an ethical analysis of the vaccine's policy options for the journal Vaccine, sees things differently. As a professor of family medicine at the University of Pittsburgh who has served on the committee that advises the CDC on immunization policy, Zimmerman says that just because a school-linked mandate would work well is not reason enough to impose it.
Proponents of mandatory vaccination are invoking the philosophy of utilitarianism, the notion that decisions should be made to provide the greatest good for the greatest number of people, Zimmerman says. That philosophy, he says, can be used to justify all sorts of ethically suspect behavior. Although he plans to have his daughter vaccinated against HPV, he says he should not be coerced to do so.
"HPV is not caught by sitting next to someone in class but by sexual contact, which often is a lifestyle choice," he says. "Using school laws, which were developed to protect children from communicable diseases like smallpox and measles, to mandate vaccination against a sexually transmitted infection, is to use the ends to justify the means."
As for other vaccine mandates, such as those for measles or whooping cough, Zimmerman says that other ethical principles justify those requirements -- notably the notions of beneficence (doing good) and nonmaleficence (doing no harm), Zimmerman says. "If a person who is unvaccinated brings measles or pertussis [whooping cough] to school, their mere presence can lead to harm to other children," particularly to those children who cannot receive the vaccine for medical reasons.
However, if history is any guide, people simply don't get vaccinated unless they are required to -- at least not in numbers large enough to reduce the rate of a disease. "Mandates provide a reminder," says Dr. Louis Cooper, a past president of the American Academy of Pediatrics. When several new vaccines came online in the 1950s and '60s, including vaccines for polio, measles, mumps and rubella, disease rates did not decline significantly until states started requiring vaccination for school enrollment, Cooper says.
Although he would recommend that girls receive the vaccine, Cooper believes now is not the right time to push for a mandatory immunization law. The public, he says, is increasingly wary of new vaccines and of medicine in general. "Public trust is at the heart of all public health measures," notes Cooper; pushing for mandatory HPV vaccination now could further erode that trust.
Cooper says there's been a backlash among some groups of parents as the number of required vaccinations has grown. "The public is increasingly skeptical" of new vaccines for all sorts of reasons -- medical, religious, political. So in the current climate, he favors waiting awhile before advocating the proposed laws, to afford the public the time to learn about the vaccine and to give health professionals a chance to gather more data on the vaccine's risks and benefits, which could build a compelling case for mandatory vaccination.
Choice in parents' hands
For now, parents will be the ones to decide whether their daughters get vaccinated. Several major insurers in California are covering the cost of the vaccine -- $360 for the three shots -- for girls in the recommended age groups. Children who are uninsured or qualify for Medi-Cal can receive the vaccine through the federal Vaccines for Children program.
Doctors report that many parents are inquiring about the vaccine. But choosing the vaccine and favoring a mandatory vaccine are two different things. Although advocates and opponents of mandatory vaccines are receiving the most attention, many parents are like Sarina Araujo -- still trying to figure it all out.
Araujo works for the National Cervical Cancer Coalition, a Van Nuys-based nonprofit that provides information about cervical cancer. All three of her daughters will receive the HPV vaccine. "I am hesitant to say that the vaccine should be mandatory," Araujo says.
"But I don't see any reason why anybody would not vaccinate."