HPV vaccine hitting bumps on road to Mass. approval

Liz Hoffman

When a vaccine gets reviews this wonderful, it’s a little surprising that it would receive such lukewarm receptions in state houses across the country.

In all, 17 states have passed legislation that would require, fund or educate the public about Gardasil, Merck & Co.’s vaccine against human papillomavirus (HPV), a sexually transmitted disease responsible for 70 percent of cervical cancer cases in the United States.

But the process of the vaccine’s spread has been slow, despite approval by the Food and Drug Administration last summer.

A year has passed since the nation’s first bill mandating vaccination was introduced in Michigan. Five months have passed since Virginia became the first state to pass such a bill into law.

And then there’s Texas, where Gov. Rick Perry last February issued an executive order requiring all sixth-grade girls to receive the vaccination, only to have the state legislature file a bill several months later prohibiting such a requirement. Perry quickly gave up the fight.

Massachusetts is still putting up a fight. A national leader in public health and home of the most successful school immunization program in the country, Massachusetts has uncharacteristically lagged behind in the national debate over Gardasil.

State Sen. Richard Moore, D-Uxbridge, proposed a bill in January that would require all girls entering sixth grade to receive the vaccine. If passed, Massachusetts would join Virginia, New Jersey and Indiana in making immunization a requirement for entering school.

“Anytime we can make progress in the fight against cancer, we ought to take advantage of it,” Moore said.

In 2007, an estimated 11,150 new cases of cervical cancer will be diagnosed in this country, and roughly 3,700 women will die of the disease, according to the American Cancer Society. The incidence and death rates for cervical cancer are higher for blacks and Hispanics than for whites. The incidence of cervical cancer is highest in Hispanics, but blacks die of cervical cancer at a rate 35 percent higher than Hispanics and more than twice the rate of whites.

“You’re talking about a disease that is 100 percent eradicate-able,” said state Sen. Gale Candaras, D-Wilbraham, chair of the state’s Special Commission on Cervical Cancer and a supporter of the bill. “This is a no-brainer.”

The measure, Senate Bill No. 102, was referred to the Health Care Financing Committee, of which Moore is the chairman and on which Candaras sits. The committee heard testimony at a meeting on July 11, but has not scheduled a vote and Moore said that he will not move forward with the bill until funding is available.

That funding has come and gone once already. Gov. Deval Patrick allocated $24.8 million in his budget recommendation last February to augment the state’s immunization program, and specifically included money for 72,000 girls between the ages of 9 and 18 to receive the vaccine.

The proposal was rejected by the state Legislature.
“We haven’t given up and we’ll keep trying,” Candaras said. “I’ve spoken with the governor and he’s like-minded. This is too important to get squashed by budget problems.”

The medical benefits appear overwhelmingly clear. Based on data from preliminary studies, Gardasil is nearly 100 percent effective against the two strands of HPV that are responsible for 70 percent of all cervical cancers. It is 99 percent effective against the strands that cause 90 percent of genital warts cases.

The Centers for Disease Control and Prevention’s Advisory Commission on Immunization Practices has declared Gardasil safe and effective, and has unanimously recommended routine vaccination for 11- and 12-year-old girls, as well as “catch-up” shots for those aged 13 to 26.

But while most agree Gardasil is promising, some warn against pushing a mandatory vaccine to the public too quickly. Medical heavyweights, including the Journal of the American Medical Association (JAMA) and the Association of American Physicians and Surgeons, are urging follow-up studies to ensure long-term safety.

Cost is the most immediate barrier, and the issue that’s holding up Moore’s bill in committee. The vaccine is given in three doses, and carries a price tag of as much as $500 per shot. MassHealth, the Commonwealth’s Medicaid program, covers the cost of the vaccine for those that qualify, as does the federal Vaccines for Children program, which has income requirements.

But there is nothing requiring private insurers to cover the vaccine.

“Until we can make sure we have the funding, I’m not aggressively pushing the mandate because I want to make sure people aren’t forced into something that costs an unreasonable amount of money,” Moore said.

Emerging competition on the development side may help ease cost concerns. According to news reports, GlaxoSmithKline is close to launching its own HPV vaccine, Cervarix. Moore is hopeful that such competition would bring down cost.

It might also, he notes, calm allegations of corporate politicking. With Gardasil currently the only FDA-approved vaccine on the market, a mandatory vaccination law would be a windfall for Merck.

“The positive thing is that there are other companies manufacturing the vaccine,” he said. “It may help to bring price down … [and] it certainly will reduce the claim that Merck is trying to promote this product through legislation.”

But for the bill’s more vehement opponents, money is not the central concern. Neither is Merck’s political peddling, though many find that troubling as well.

“Patient safety comes first, and quite simply, this is not proven safe,” said Evelyn Reilly, director of public policy at the Massachusetts Family Institute, a nonpartisan organization “dedicated to strengthening the family and affirming the Judeo-Christian values upon which it is based,” according to the group’s Web site.

Reilly pointed to weaknesses in studies of the vaccine’s safety, noting that while sample sizes in older age groups were substantial — 21,000 patients ages 16 to 26 — only 1,200 girls under 15 were vaccinated, and just 250 9-year-olds, the lowest age for which the CDC recommends vaccination. While the older group was followed for five years, the younger group was followed for just 18 months.

Even JAMA, in a May editorial, cautioned that “the longer-term effectiveness and safety of the vaccine still need to be evaluated among a large population, and particularly among younger girls.”

But according to Dr. David Kimberlin, a member of the American Academy of Pediatrics who specializes in pediatric infectious diseases at the University of Alabama at Birmingham, the medical benefits vastly outweigh any potential side effects, which he says have been mild and rare.

“Every indication is that there are no long-term risks,” he said. “This is a very good vaccine, and its risks versus its benefits weigh heavily toward using it in as wide a capacity as possible.”

Looming in the background — and most heatedly advanced by family groups — is the issue of parental rights. Moore’s bill currently includes no “opt-out” provision that would enable parents to prevent their daughters from receiving the vaccination, although he said he would consider one, albeit unhappily.

But according to Reilly, opt-out provisions are missing the point.

“It should be opt-in, not opt-out. This is riding roughshod over parents’ rights,” she said. “If a letter gets lost in the mail or if a child forgets to bring it home from school, then children are forced to [be vaccinated] without parental consent.”

Finally, questions of morality further cloud the use of the vaccine.

“The most significant difference between this and, say, a chickenpox vaccine is that this is for a sexually transmitted disease,” Reilly said. “You don’t get [HPV] sitting next to a child in a classroom.”

Reilly also warned of a “false sense of security” that could go along with a mandatory vaccination.

Kimberlin, however, thinks that is unlikely.

“That an 11- or 12-year-old [who had been given the vaccine] would be more likely to engage in sexual activity seems like a disconnect in my opinion, and I’ve seen no data to support it,” he said. “Kids don’t think about the same things that adults think about. At that age, they think they’re bulletproof; this can help protect them.”

Candaras also noted that the HPV vaccine would protect girls who are infected despite responsible sexual behavior.

“Let me be very clear: You can be pure as snow until the day you are married and if your partner has had one sexual encounter with someone with HPV, you can end up with cervical cancer,” she said. “If you could protect your daughter from ever having that eventuality, and all you need to do is give her a shot, wouldn’t you do that?”

As family groups weigh in, medical groups express hope while cautioning against premature policy decisions, and public health officials herald the next major step in the fight against cancer, the Commonwealth’s girls remain at the epicenter.

“Everyone’s looking out for the best interest of their daughters and nieces and granddaughters,” Candaras said. “One hundred women will die [from cervical cancer] in Massachusetts this year, and this vaccine can stop that. You can say whatever you want, but that’s the truth, and what we do now, how we act in the face of this, will be judged.”

At least 25 states are now considering similar legislation, and many are hitting the same legislative roadblocks as Moore. At least two bills, in Florida and Mississippi, are labeled dead in committee, and California and Maryland have withdrawn their bills. In the vast majority of other states, the legislation did not make it to a vote before the end of the 2007 session.

“Part of it I think is a funding issue, because there is a cost associated with [mandating vaccination],” Candaras said. “But there’s also the characterization of HPV as a sexually transmitted disease, and the minute you get into any of those issues, people are more wary than if you were talking abut measles or rubella. It stops being simply a public health issue.”