By Rob Stein
Washington Post Staff Writer
Tuesday, November 7, 2006
Amy Groff has heard all about the new vaccine that guards girls against a sexually transmitted virus that causes cervical cancer. But the Cincinnati mother has no interest in getting her 11-year-old inoculated.
"We haven't even talked about the birds and the bees yet," Groff said. "She needs to be innocent a little bit longer."
Ellen Hoffman, who lives outside Chicago, also has decided to hold off giving her 11-year-old daughter the shots. Her reason, though, is that the vaccine is so new.
"We don't know enough about it to know whether it's safe," Hoffman said. "If children are not in a risky situation, then it seems to me it's better to wait and see."
While many parents are clamoring for the vaccine for their daughters, others are less enthusiastic. Some worry about safety. For others, it's the cost. For still others, it's queasiness about even thinking about sexual activity among girls so young.
The reservations highlight the complex matrix of social, psychological, economic and logistical obstacles that public health authorities face in trying to spur widespread use of the vaccine, which is being hailed as one of the most important advances in women's health in decades.
"This is not going to be easy," said Jon S. Abramson of the Wake Forest University School of Medicine, who chairs an influential expert committee that advises the government about vaccines. "This is a really important vaccine. But it's going to be complicated. This raises some issues we've never had to deal with before."
The vaccine, known as Gardasil, protects against human papillomavirus (HPV), a ubiquitous sexually transmitted virus that causes genital warts and cervical cancer. In June, the Food and Drug Administration approved Gardasil for women and girls ages 9 to 26, making it the first vaccine marketed specifically to prevent a cancer.
Experts are recommending that girls start getting the vaccine routinely at age 11 or 12 in the hopes of catching them before they become sexually active and saving them from a malignancy that strikes about 10,000 women in the United States each year and kills about 3,700, according to the American Cancer Society.
"This is now a vaccine-preventable problem," said Stanley Gall of the University of Louisville, a spokesman for the American College of Obstetricians and Gynecologists. "We have a huge opportunity to make a significant improvement in the health care of women."
The prospect of the vaccine initially raised alarm among groups promoting sexual abstinence until marriage, who feared it might encourage promiscuity. Most now say they support the shots, as long as parents can decide whether their daughters get vaccinated and it is not mandatory for school. Such a requirement is advocated by many experts and has been proposed in at least one state, Michigan.
Interviews with pediatricians and parents around the country in recent weeks indicate that most are enthusiastic about the vaccine. Many doctors promote it, many young women want to get it, and many parents are eager to have their daughters inoculated.
"We're seeing a fairly remarkable uptake of Gardasil," said Rick Haupt of Merck & Co., which reported sales of the vaccine had reached $70 million, exceeding analysts' projections.
Deborah Hager of Perkasie, Pa., immunized her 11-year-old daughter, Rachel, even though she is raising her to be abstinent until marriage.
"I just figured I might as well give it to her now so we know she's protected," Hager said. "Hopefully, she'll believe as we do, but you don't know what's going to happen down the road."
But the vaccine faces significant hurdles, experts say, not the least of which is the price. At $120 a dose, plus doctors' charges, a full three-shot series costs $400 to $500. While many insurance plans are covering the vaccine, others have not yet decided, have not determined how much they will reimburse or have not announced when their reimbursements will begin.
As a result, while many pediatricians are stocking the vaccine, others have delayed ordering it, saying they are unable to pay thousands of dollars without being assured they will recover their costs.
"Nobody is receiving Gardasil in my office until some accommodation is reached where I can afford to purchase the vaccine," said Dan Levy, an Owings Mills, Md., pediatrician.
Even if their pediatricians are stocking the vaccine, some parents are waiting until they know whether they will be reimbursed.
"Some parents say, 'Yes, I'm going to get it, and I don't care about the insurance,' " said Edward Rothstein, a Sellersville, Pa., pediatrician. "But more often they say, 'Let me go home and check with my insurance company.' Girls who should be getting it aren't getting it because parents are justifiably concerned about cost."Wait and See
Because of the uncertainties, some doctors are telling parents of young girls to wait a year until the insurance situation sorts itself out.
"My approach has been, 'I have this great new vaccine. I think everybody needs to get it. But because it's so new and so expensive and you have to have three doses, if you are not in that just-ready-to-have-sex age, let's wait a year and see if the insurance company picks it up,' " said Pamela Parker, a Silver Spring pediatrician.
Proponents of the vaccine say they are encouraged by the number of insurers that have committed to covering the vaccine, and they expect others to follow soon. Merck officials say the company is taking steps to mitigate the cost, including giving pediatricians more time to pay for their stocks and providing it free to poor women.
"We're doing whatever we can to make sure cost is not a barrier," Haupt said.
For poor uninsured children, Merck this week announced it had reached an agreement with federal health officials to make the vaccine available at a discounted price to state programs for the indigent.
After the insurance issue is resolved, experts say another complication will be the logistics of getting pre-pubescent and teenage girls into a doctor's office three times within a six-month period for the shots. Unlike for infants, there are no standard office visits for girls in that age group that would facilitate three separate shots.
Then there is the issue of safety. While the vaccine has been tested on thousands of women who were followed for as long as five years, some parents want more time to go by to be sure.
"There just isn't enough information on it yet to make a call about whether it's safe," said Gina Catizone of Northbrook, Ill., mother of a 10-year-old. "I'm not rushing out to do this."
And although studies show the most effective way to use the vaccine is before girls become sexually active, some parents and pediatricians balk at that idea, saying girls that age are too young to have the subject broached.
"It's almost an assault on their innocence to be talking about those things when they do not even know what I'm talking about," said David Castellan, a Lewisburg, Pa., pediatrician.A Question of Timing
Some parents and pediatricians worry the vaccine may give girls a false sense of security.
"If they think they are protected against one venereal disease, they may think they're protected against all venereal diseases," said Ravinder Khaira, a Sacramento pediatrician. "That's just the way some kids think."
Others say they are not convinced the protection will last into adulthood. So some pediatricians are advising parents who are confident their daughters will be abstinent until they are older, perhaps even until marriage, to wait.
"I would like to protect them at the point of being exposed -- like what travelers do before heading off to a country with endemic disease," said Joseph Zanga, a professor of pediatrics at East Carolina University in Greenville, N.C.
Merck's Haupt acknowledged that studies have documented immunity for only five years, but said evidence suggests the immunity is long-lasting. "We have ongoing surveillance studies suggesting it will have a durable immune response," he said.
Supporters argue that parents have no way of really knowing when their daughters will become sexually active or whether they may be sexually assaulted. And even if they remain abstinent until marriage, their husbands may be infected.
"It really does make the most sense to immunize girls when they are 11 or 12," said Susan Rosenthal, a professor of pediatrics at the University of Texas Medical Branch in Galveston. "That way you're done, and you know they are protected." ·