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The Birds, The Bees and HPV

When Michelle took her 8-year-old daughter for the girl’s annual physical in November, she expected all the usual procedures: a review of vaccinations, measurements of height and weight, and, of course, instructions to come back for a flu shot. She wasn’t prepared to talk to the doctor about a vaccine for a sexually transmitted virus.

Most parents can expect to have a few interesting conversations with their children’s doctors over the years. But the development of vaccines for the human papillomavirus has given pediatricians and parents an unusual challenge, along with the chance to prevent thousands of cancers.

Local physicians say parents need to take the initiative to get their children vaccinated because HPV is an extremely common virus, and some high-risk forms of it can cause cervical cancer in females who are infected. Although women are usually diagnosed with cervical cancer between ages 35 and 55, they were probably exposed to the virus in their teens or 20s. According to the Centers for Disease Control and Prevention, more than 20 million people are infected with HPV, and cervical cancer claims the lives of approximately 4,000 American women every year, some 275,000 women worldwide.

And the virus is extremely contagious. Although it is often transmitted through sexual activity, HPV can also be passed through non-intercourse skin-to-skin and mucous membrane contact.

The first HPV vaccine to obtain Food and Drug Administration approval is Gardasil, developed by Merck & Co. Approval was given for vaccination of females 9 to 26 years old on June 8, 2006, and local physicians are just beginning to offer the vaccine to their patients. Gardasil, administered in a three-dose series, induces an immune response against strains of HPV that are responsible for precancerous genital lesions, genital warts and about 70 percent of cervical-cancer cases. Another vaccine, GlaxoSmithKline’s Cervarix, is expected to receive FDA approval by next spring.

The Sooner, the Better

The CDC recommends vaccinations for girls at age 11 or 12. Michelle, a Cicero mother who asked that her last name be withheld to protect her daughter’s privacy, says she is happy there’s a vaccine that could protect her daughter against one of the most deadly forms of cancer. However, she believes the age recommendation of 11 to 12 (which her doctor’s practice and the others included in this story are using as a guideline for when to offer the vaccine) is too young. And she is not sure she would give consent if her daughter were old enough to receive it.

“I had just been hearing about HPV on TV and stuff, but I wasn’t aware that there was a vaccine,” says Michelle, who also has two older children. “Our doctor told me a little bit about it. But I was a little concerned about this coming up at such a young age. It seems to me that it should be for older girls.”

Dr. Joseph Domachowske, a professor in the infectious diseases division of the Department of Pediatrics at SUNY Upstate Medical University in Syracuse, says the age recommendations are designed to get girls protected before they even have a chance to be exposed to the virus.“We must vaccinate these girls before their sexual debut,” he explains. “We already have an adolescent immunization platform to deliver other vaccines at ages 11 and 12. It takes a minimum of six months to complete this series.” In fact, he says, vaccinations for Hepatitis B—”a largely sexually transmitted disease”—start at birth.

“The other reason that younger is better is that antibody titers (the amount or concentration in a patient’s blood) are highest from HPV vaccine in the youngest patients—down to 9 years,” Domachowske says. “The younger we get them, the better they work. If the vaccine is delayed to the point where HPV disease is already present, we know the vaccine won’t work.”

Child Health Care Associates, a nine-physician practice with offices in East Syracuse and Liverpool, started offering the vaccine to patients in October. Dr. Rosalind Odin says the response from parents has been encouraging. “I would say we are getting 80 percent of the people we’re offering it to,” she says, adding that the practice has about 3,000 patients within the recommended age range for receiving the vaccine.

“I think it is a very good vaccine. It is very safe. There are no side effects,” Odin says. Although most parents have opted to have their daughters vaccinated, there are plenty who have decided to “wait until next year” or who decline altogether.

“Moms want to wait, and I understand their hesitations,” she says. “Parents don’t like to think about the possibility of their children being sexually active at that age. But, really, the point is to get them vaccinated before they become sexually active, before they’re infected. Abstinence? Absolutely that’s the best prevention. But you have to be a realist.”

Dr. Nancy Blake, a Liverpool family doctor who also started offering the vaccine in the fall, says recent media reports and television advertisements have increased awareness about the HPV virus. Hence, parents are generally open to the idea of getting their daughters vaccinated. “So many women know about HPV now, and that’s been
helpful in talking to them about this vaccine,” she says.

Dr. Michael Soeder of Brighton Hill Pediatrics in Syracuse says those recent ads about the vaccine have prompted parents to ask questions, but the cost is keeping some patients from getting it. Gardasil costs $360 for a three-dose regimen. “There is a lot of discussion going on right now, and I think that by later winter or spring, all of the major local insurance companies will be on board and the vaccine will be covered for most patients,” he says.

Indeed, Dr. Lisa Gaffney, a pediatrician with St. Joseph’s Hospital’s Maternal/Child Health Center in Syracuse, says the vaccine is too expensive for many of her patients. The center provides care to uninsured and Medicare patients. “They’re working on (expanding coverage), and most definitely it’s something we will be offering to our patients,” Gaffney says.

Onondaga County Health Commissioner Dr. Cynthia Morrow says the New York state Department of Health will soon be making the HPV vaccine more widely available through the Vaccines for Children (VFC) program, although demand exceeds supply. The program offers reduced-rate vaccines to Medicaid recipients and uninsured children.

Getting Boys on Board

Currently, Gardasil is not available to male patients. While males can carry and transmit the HPV virus, they were not included in initial clinical studies because those studies focused specifically on cervical cancer. HPV can cause genital warts and has been linked to rare cancers in males. Gaffney says males have a slight advantage when it comes to treatment for the maladies caused by HPV because they are more likely to show external signs of infection.

Studies on the vaccine’s effectiveness in males are not yet completed. Odin, of Child Health Care Associates, says she believes the HPV vaccine will be offered to males as soon as those findings are presented. “I would love to (vaccinate) all the 11- and 12-year-olds so that they would all be protected,” she says.

All the doctors interviewed emphasized the importance of getting males vaccinated. “I do think males need to be vaccinated because that’s where women get it,” says Dr. Blake, a mother of a young son and daughter.

Domachowske adds, “It never made sense to me to vaccinate 50 percent of a population against a sexually transmitted disease.”

But Soeder predicts some difficulties in getting teen boys to acknowledge their need for the vaccine. “I’m thinking that’s going to require a specific effort to get (males) educated. That’s tough because teenage boys are typically not forthcoming in discussing sex with their doctors.”

Sex, Morals and Wishful Thinking

Didi Leavitt, a DeWitt mother of three daughters, and wife of pediatrician Wayne Leavitt, says while it may not be easy to face the facts about our children’s future, the vaccine offers a way to protect them from one malady associated with sexual maturation.

“It is so easy for us to think about human sexuality in broad terms, but when we narrow the focus to include our own children, how quickly we revert to wishful thinking,” Leavitt says. “I wish that there were no venereal diseases that could possibly ever come within 100 miles of my children, but that is not reality. I hope that my girls grow up to cherish the power of their sexuality, and to understand the importance of finding the right partner in their lives. But I know that a life partner usually comes after you have lived, and loved, and have grown from the experience. I wish I could keep my children safe just by thinking about it, but action seems the wiser, more parent-like course.”

Odin says some of her teen-age patients have spoken to her privately about the vaccine. “Some of them don’t even tell me if they are sexually active. But there is an awareness of HPV,” she says, partly spurred by Merck’s recent advertisements.

Lisa Morgan, a nurse at Liverpool High School, has not had any questions from students about the vaccine yet, but she agrees that the CDC’s recommendations reflect the realities of modern life.

“As health care providers, we can continue to promote good health by encouraging safe sex and having (girls) talk with their doctors about the vaccine. Let’s hope parents feel the same way and will continue to talk with their teen-age girls,” she says, adding, “If (this vaccine) means we can prevent a woman from contracting cervical cancer often caused by the HPV virus, I am on board.”

As promising as the scientific battle on HPV appears, local doctors acknowledge that there are still questions about Gardasil’s effectiveness. There are no data available on long-range side effects, although the clinical studies are now 5 years old, and it is unclear how long those who receive the vaccine will be protected.

But Domachowske says the projections are encouraging. “The efficacy becomes more obvious as the clinical vaccine trials get older because HPV-associated diseases can take years to show up,” he says. “Mathematical models are already predicting that protection will continue for several decades. Even if it doesn’t, we can always add a booster vaccine later in life. We already do that with several other vaccines that we use.”

Hastings resident Cassandra Crane, mother of a girl who will be old enough to receive the vaccine in about a year, says her pediatrician has not yet talked to her about the vaccine, but she plans to read up on Gardasil. “I am not in a huge hurry to try something new without really having an education on it,” she says.

Leavitt, who has the unique parental advantage of having a medical expert at home, has no such hesitation. “In the end, saying yes to the HPV vaccine is a simple choice,” she says. “Hoping that our children will escape from contact with a virus because we have taught them to be moral seems foolishly optimistic.”

Perhaps the best indication of doctors’ confidence in the vaccine is their response as parents. All of those interviewed here predict that their children will get the vaccine. “My own daughter is 16 and she got the vaccine, pronto,” Odin says.


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