By Susan Levine
Washington Post Staff Writer
Sunday, March 4, 2007
In barely nine months, the first cancer-specific vaccine to win federal approval has gone from licensing and the enthusiastic embrace of dozens of states to a widespread backlash against moves to mandate immunization for adolescent girls.
Health experts are dismayed by the controversy over Merck's Gardasil, which protects against two common forms of the sexually transmitted virus that causes cervical cancer. But it has hardly surprised them. Never has compulsory use of a drug been pushed with such breakneck speed -- with concerted lobbying by its manufacturer. Never have such efforts advanced largely through political and legislative channels instead of medical authorities and public education campaigns.
Votes to require the three-dose vaccine before students enter the sixth grade remain likely in the District and numerous jurisdictions. On Friday, Virginia Gov. Timothy M. Kaine (D) announced he would sign the first bill in the country to prescribe vaccination, albeit with an opt-out provision. However, doctors question whether there will be adequate funding and access to support these measures, and some fear that the opt-out clauses, included to counter opponents' concerns, could erode support for immunizations in general.
If parents are given broad opportunity to exempt their 11- and 12-year-old daughters from the vaccine for the human papillomavirus, or HPV, will they be less willing to have children of any age inoculated against other, more communicable diseases?
"The message that we send to parents is exceedingly important," said Gary Freed, a professor of pediatrics and health policy at the University of Michigan and chairman of the federal government's National Vaccine Advisory Committee. "Are we going to be creating a culture of vaccine refusal that's not going to serve us well?"
Few people dispute the promise of the new vaccine, which clinical trials proved to be highly effective against two HPV strains that cause nearly three-quarters of the 10,000 annual cervical cancer cases in the United States. About 40 percent of women who receive the diagnosis die. Low-income and minority women are most affected, with African American mortality rates more than twice that of whites.
Still, for some parents those numbers might not be great enough to justify state intervention. Maureen Siegel of Manassas, who has a 10-year-old daughter, acknowledged she must learn more. "I don't know everything there is to know about the basics," she said. "I also don't know if cervical cancer is a big enough epidemic to make [vaccination] mandatory."
Because the virus is transmitted through intimate contact, the arguments for required vaccination differ from the rationale for enforcing shots against diseases easily spread in schools, such as measles. They are less about safeguarding the public and more about safeguarding individuals.
"Why is this happening so fast? Why is there a mandate when this is such a different kind of disease?" asked Barbara Loe Fisher, president of the National Vaccine Information Center, a nonprofit consumer organization that opposes HPV legislation. Most states did not add the chickenpox vaccine to schoolchildren's immunization schedules until several years after its approval in the mid-1990s, she noted.
Yet the backlash is also about the age of children targeted. Although the government approved Gardasil for women up to 26, it recommended routine administration to girls 11 and 12 to ensure they be protected before they become sexually active. The vaccine is most effective when given before first sexual contact. Its duration is unclear.
Some people argue that vaccination could encourage adolescents to be more promiscuous. More believe that parents' authority over their daughters' health care would be usurped. Others point out that cervical cancer will occur in only a fraction of the more than 7.5 million girls and young women estimated to be infected with the virus in this country.
A Maryland state senator retreated quickly in January after being deluged by irate letters about her bill for mass HPV vaccination before middle school. Still pending is a second bill to create a task force of legislators, teachers and health professionals to study the issue through 2008.
"I thought it was imperative to continue the conversation," explained Del. Joseline Peña-Melnyk (D-Prince George's), who introduced the study initiative. "People need to be educated on the issue in order to be able to support it."
In the District, a mandatory immunization bill could be voted out of the D.C. Council Health Committee as early as Friday. One sponsor, council member Mary Cheh (D-Ward 3), has heard mixed reaction from residents, with the positive responses coming "almost uniformly from women."
"I really hope people don't lose sight of the fact that this is the first time we've ever had a vaccine against a cancer," Cheh said. "You seize and take advantage of it."
Local health experts urge more deliberate consideration. "There has to be a period of awareness," said Joseph Wright, executive director of the Child Health Advocacy Institute at Children's Hospital in Northwest Washington. The hospital has not decided its position on the council's pending bill. "Legislators would be wise to recognize the way the public winds are blowing and build in a very strong public education campaign before stressing the mandatory aspect."
Kim Koontz Bayliss, for one, was initially angered by the proposal, seeing it as an intrusion on her judgment of what is best for her 11-year-old, Nell. The Cleveland Park resident has come around some in the past month. After a television commercial on Gardasil prompted questions from her daughter, she read up on HPV and the vaccine. Nell is due soon for her annual checkup, and her mother plans to discuss it with the doctor.
But, she added, "I'm not going to make a move until I talk to the pediatrician."
Virginia's legislation would not take effect for most sixth-grade girls until the 2009-2010 school year. (In Texas, an executive order recently issued by Gov. Rick Perry (R) would begin mandatory HPV immunization there in September 2008.) Proponents say the lengthy notice will allow enough time to watch for complications as the vaccine is used more broadly. In the clinical trials, in which 11,000 girls and women participated, a slight soreness at the site of injection was the only identified side effect. Recent reports suggest some cases of fainting, dizziness, fever and nausea.
"It's a very cautious approach," said Del. Phillip A. Hamilton (R-Newport News), who championed the bill. It passed with no organized opposition.
Both he and Kaine have stressed the opt-out clause, which will allow parents to say no without explaining why. Some contend that if enough children are excluded, there will be little strength left in the requirement.
"We have no clue yet what the uptake will be for this vaccine," said Jon Abramson, chairman of the committee that advises the federal Centers for Disease Control and Prevention on immunization practices. The panel never addressed the issue of inoculation as a condition of school attendance. Abramson, who also is a professor of pediatrics and infectious diseases at Wake Forest University medical school, does not support the legislative moves.
Although mandates help reduce disparities in health care, he agreed, they have to be funded. And cost is a key concern in his mind: A three-dose regimen of Gardasil, given over six months, runs $360 or more, and a significant part of the population would have to pay out of pocket because families lack private insurance or do not qualify for a subsidy through the federal Vaccines for Children program. Dollars often follow mandates, but they are not guaranteed. Virginia is unusual in that Kaine has added $1.4 million to the budget for coverage.
"It's very, very unclear to me that states have the money to pay for it," Abramson said, "and I would be very concerned that kids would be kicked out of school because parents can't pay."
Maryland's recent experience with older students and vaccines provides little reassurance of early compliance. Thousands of teens were barred from school for weeks in January because they didn't get newly required chickenpox and hepatitis B shots -- despite extensive publicity and free clinics.
Abramson advised Merck & Co. not to lobby lawmakers over Gardasil. Merck disregarded his and others' suggestion, until its role became such a distraction that the company stopped two weeks ago.
"Politics are not a good driver of health-care recommendations," Abramson said. "Time will help us decide what's the best policy."
Staff writers Theola Labbé and Christy Goodman contributed to this report.