July 27--When their daughter's pediatrician suggested that their 15-year-old daughter Melanie get vaccinated against Human Papillomavirus, the most common sexually transmitted virus, Mike Poller and his wife had some concerns.
Gardasil -- one of two vaccines that protect against HPV, a virus that can cause cancer -- was new and unfamiliar to the Pollers. Unlike with most vaccines, they never received the HPV inoculation, since it wasn't around when they were kids. There also isn't any long-term data showing the immunization's effectiveness.
"Fundamentally, my daughter is a human guinea pig, and that was the main mental stumbling block," Poller said.
Five years later, Melanie, who eventually did get vaccinated, is off at college and the HPV vaccine -- approved for U.S. use in 2006 -- is far less controversial. And even though many associate the vaccine with cervical cancer, since the vaccine's approval for males in 2009, parents have increasingly elected to vaccinate both their daughters and sons.
As August and the time-honored tradition of the back-to-school checkup approaches, parents of both girls and boys are faced with the same decision as the Pollers: Whether to add the HPV vaccine to routine physicals for 10- and 11-year-olds, like flu shots and tetanus boosters.
In many cases, HPV -- so common that nearly everyone who is sexually active will contract it at one point in time -- does not affect the infected person's health and goes away. However, the virus can cause cancers in the cervix, vulva, vagina, anus, oropharynx (back of the throat) and penis, as well as genital warts, according to the Centers for Disease Control and Prevention.
Though the optimal age for the HPV vaccine is 11 or 12 -- before the start of sexual activity -- girls and women can be vaccinated between the ages of 9 and 26 and males through the age of 21. Competitor Cervarix is only approved for girls, and prevents against fewer strains of HPV than Gardasil.
HPV vaccinations in Florida are largely consistent with national rates: A quarter of Florida teen girls got all three shots of the vaccine in 2012, and nearly 40 percent got the first dose. Because Gardasil was only approved for males about five years ago, vaccination rates for teen boys trail females: about 20 percent of Florida teenage boys received at least one dose of the three-dose vaccine, according to CDC data from 2012.
The CDC "strongly" recommends the vaccine for both genders, said Shannon Stokley, associate director for science for the immunization services division of the CDC. She noted that Florida is one of the states with the highest rates of HPV-associated anal, cervical and oropharyngeal cancers, per 2004-2008 CDC data.
The American Academy of Pediatrics also strongly encourages the vaccine, expressing concerns last summer about "low, stagnating vaccination rates." And for many local pediatricians, getting the vaccine is a no-brainer.
"There's always been a little of resistance in the past, even with girls -- some parents didn't want it, wanted more info on it, wanted to wait until it's been out a little longer. That's died down a little bit," said Dr. Javier Hiriart, a pediatrician at Baptist Hospital's family medicine center. "The impetus has always been on vaccinating girls, but now we're trying to make it universally available."
Hiriart and fellow local doctors say early criticisms of the vaccine were due to a lack of education. The relative newness of the drug also meant that initially not all insurance companies covered it.
Dr. Lawrence Friedman, director of the University of Miami's division of adolescent medicine and a practicing pediatrician, said patients and their parents have grown increasingly familiar with the vaccine.
"When it first came out, there were lots of questions from parents about the need for it and why it was administered at that age, targeting preteens," Friedman said. "As information got out about it, the level of acceptance was greater -- there were few side effects and people got more comfortable with the idea that it was preventing cancer."
Though the CDC says the vaccine's side effects are mostly minor -- redness or swelling at the injection site, fever after vaccination and fainting, common after any type of injection -- there are people who have reported more harmful side effects. Since 2006, the National Vaccine Injury Compensation program compensated 71 of the 149 HPV vaccine claims that were filed. Among the side effects reported: blood clots, seizures and death.
Dr. Diane Harper, a lead researcher in the development of Gardasil, and the chair of the Department of Family and Geriatric Medicine at the University of Louisville, has spoken out against the vaccine, questioning whether the vaccine's benefits outweigh its risks.
Routine pap smears can catch pre-cancers before they turn into cervical cancer, and even after getting the HPV vaccine, women must continue to get pap smears, Harper noted. Gardasil only protects against the four most common strains of HPV, which means that not only can women still get cervical cancer even if they're vaccinated but that routine testing would catch cervical cancer before it developed, she said.
Moreover, since the introduction of pap smears, cervical cancer rates have been dropping since the 1950s, according to the National Institute of Health. Once the top cancer affecting U.S. women, cervical cancer is now the 14th most common cancer for women, according to the NIH.
In particular, Harper takes issue with the advertising used to promote Gardasil -- which feature different women saying that they could be "one less statistic" and "one less woman who will battle cervical cancer."
"The advertising campaign of 'be a mother who makes sure her daughter is one less' is full of innuendo. She's never going to be a cancer victim anyway if she participated in a pap smear program. Even if she did get the vaccination, the fact that she could have cervical cancer from one of the other 13 types of HPV that Gardasil doesn't prevent against, doesn't mean she's going to be one less," Harper said.
Like the Pollers, parents must weigh whether the vaccine's possible benefits -- reducing the future risk of an uncommon cancer -- outweigh the possibility of side effects. Harper says they don't.
If parents are intent on vaccinating their daughters, Cervarix -- which is only offered for females -- is the "superior vaccine," because it doesn't have the same advertising dollars that Merck put behind Gardasil, Harper said. As for vaccinating boys, Harper said that there's "no strong data" to support connections between HPV and other cancers besides cervical cancer.
There's also no data proving the vaccine actually prevents cancer in the long term, according to Harper.
"You can be hopeful all you want, speculate all you want, argue by simile all you want, but reality is science is science and you have to show data," she said. "Absolutely all of the things we do in medicine have side effects, no matter how well-intentioned, so why would you risk doing anything that would cause a side effect if you weren't convinced yourself that the benefit outweighs any possible side effect?"
Despite the lack of data on the vaccine's long term effectiveness -- since the vaccine has only been out since 2006 -- the CDC's Stokley said the government agency has confidence in studies that were conducted pre-licensure.
"Everything indicates this vaccine will have long-term protection," Stokley said. "We strongly recommend all adolescents receive this vaccine. It's safe, and it's effective, and it can protect teens against infection. We've been monitoring the adverse effects and really haven't seen any serious side effects. They're very rare, if they do occur."
Stokley said the immunization is particularly important for gay and bisexual men, who may be at increased risk of infection for HPV and HPV-associated cancers.
Unlike with cervical cancer, which women can detect through yearly pap smears without having the vaccine, there are no recommended screenings for the other types of HPV-associated cancers, Stokley said.
As for Mike Poller, he says he's glad his daughter got the vaccine. Ultimately, the prevalence of the virus -- it's the most common sexually transmitted infection in the country -- was the deciding factor for him and his family. Getting the vaccine "just seemed like a reasonable thing, after all of the mental juggling and family discussions," Poller said.
"Every day, you have to make choices for your child, and this is just another one," he said. "I'm willing to let my kid drive to her friend's house across town, and there's probably more danger in that than in giving her the HPV shot."
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