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Here's a scenario: In a triumph of biomedical research, a safe and effective vaccine to prevent cancer is developed, tested for safety and brought to market. The only problem? It seems as if no one wants it, with barely a third of the population even bothering to get vaccinated.

That's not the pitch for a work of fiction — the vaccine is real and so is the poor reception, and if you have never heard of the cancer vaccine, that lack of clear communication might be part of the problem.

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It was in 2006 that pharmaceutical company Merck and Co. released Gardasil, the first and — along with Cervarix from competitor GlaxoSmithKline — one of only two vaccines so far known to prevent cancer, namely cervical, vaginal, penile and anal cancers.

The vaccines are often referred to collectively as the HPV vaccine, which protects those vaccinated from being infected by several strains of the human papillomavirus. It's the virus that causes genital warts, according to the Centers for Disease Control and Prevention, and is also the most common sexually transmitted infection, with most sexually active people contracting it at some point.

HPV also happens to be a major cause of cervical cancers in women and is also implicated in vaginal and vulvar cancers, as well as anal cancers in both genders, according to the CDC, which estimates that 21,000 cases of HPV-related cancer arise annually that could be prevented with the HPV vaccine.

The vaccine was originally recommended for girls between the ages of 11 and 12 in order to pre-empt sexual activity and is now recommended for boys at the same age, but vaccination rates remain inexplicably low, said Greg Reed, program manager for the Maryland Center For Immunization within the Department of Health and Mental Hygiene.

"You've got a vaccine that prevents cancer. So what's the problem?" he said. "In Maryland our three-dose completion rate for 13- to 17-year-olds is 33 percent ... that's for the girls. For boys, the rates are so low that they don't even have a marker on that. That's the state of affairs."

While the DHMH does not keep vaccination statistics at the county level, the Carroll County Health Department does have records of the doses of HPV vaccine it has given out over the past few years, according to Director of Nursing Cindy Marucci-Bosley. Although the majority of vaccinations given in Carroll take place at private doctor's offices, the health department does provide vaccines to children without private insurance. Very few of those inoculations are for HPV.

"In calendar year 2011, we gave nine doses; 2012, 10 doses; and 2013, five doses of HPV [vaccine]," she said. "I do not have any way of knowing if these were dose No. 1, No. 2 or No. 3. HPV is not a popular vaccine."

That unpopularity has a cost. Looking at cervical cancer alone, the National Cancer Institute estimates more than 12,000 new cases will be diagnosed in 2013 and that just more than 4,000 women will die from the disease.

In Maryland, there were 232 new cases of cervical cancer in 2010, the latest year for which the DHMH has data available, and there were 64 deaths from the disease.

"This is an issue that the DHMH is taking on very strenuously to see what we can do as a department and with our partners to see what we can do to increase the [vaccination] rates for boys and girls," Reed said. "CDC has issued several calls to action and all the major medical groups, like the American Academy of Pediatrics, they have doubled down on efforts to educate their members about the importance of the vaccine."

There are a number of factors that seem to be involved in the poor reception of the HPV vaccine, Reed said, but chief among them seems to be a lack of information or unease on the part of parents. Many parents are concerned because it is a relatively new vaccine, or because they are suspicious of vaccination in general, he said, and many others are uncomfortable with giving a vaccine for a sexually transmitted disease to their newly pubescent children.

But if those are the objections parents raise, it is private doctors who are hearing them and perhaps not dealing with them effectively, or even failing to recommend the vaccine altogether, Reed said. He said that the DHMH recently sent a letter signed by its secretary, Joshua Sharfstein, to all the vaccine providers in the state, emphasizing the importance of their role in increasing the vaccination rate.

"A strong doctor recommendation leads to greater vaccination rates for children," Reed said. "If the doctor is telling the parents, 'Your child should receive this vaccine,' it greatly increases the likelihood that that child will end up getting the vaccine. One of the things we are trying to do is to focus on the education to help the providers realize that their recommendation carries a lot of weight."

That a doctor recommendation, or rather the lack thereof, is the key missing piece in the vaccination puzzle is also the conclusion of a study by the American Academy of Pediatrics published in August. With 124 parents or guardians surveyed, the most common reason for not vaccinating children was the doctor's failure to recommended it. Of the reasons for not recommending the vaccine given by the 37 providers surveyed in the study who reported low vaccination rates, the belief that sexually inactive children did not yet need the vaccine was common, which might indicate that doctors, too, are uncomfortable talking about a vaccine for a sexually transmitted infection, at least with parents.

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And potentially with anyone else. Of eight family practice physicians' offices in Carroll County called in relation to this story, only two had physicians willing to speak; the other six either declined to comment or never responded. Those two physicians, Dr. Wendy Miller, a Carroll Health Group Primary Care doctor in Eldersburg, and Dr. Timothy Pearl, of Carroll Pediatric Center in Sykesville, both recommend the vaccine to their patients and parents, and both see the same challenges and objections that Reed mentioned.

"I think it's a combination of parents and doctors. ... A lot of times, there may be physicians that don't bring it up. I am pretty passionate about it and feel pretty strongly that somebody has got to bring it up," Miller said. "I am sure there are parents that say no, since they say no to me. They overlook it or they put it off, they say they will think about it."

Putting the decision off is common in Pearl's office as well.

"The most common reaction [from parents] is that it is new and they want to follow up and see after a couple of years," he said.

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Getting more doctors to recommend the vaccine will help, but might not be sufficient, according to the American Academy of Pediatrics study, which noted that "some parents believe that HPV vaccination is unnecessary even after speaking with providers, indicating communication gaps."

One possible solution, according to Miller, is for doctors to begin reaching out directly to the teens who are the beneficiaries of the vaccine. Minors are allowed to discuss and consent to medical treatments involving sexual health in confidence under the Maryland minor consent law, Miller noted, but there are practical problems that prevent her from giving the HPV vaccine in this way.

"Most minors are on their parents' insurance, so when they come to the doctor, the parents get the bill," Miller said. "If their goal is to get it against their parents' consent, that makes it harder for kids to come to the doctor's office and ask for any kind of help while on their parents' insurance."

In most cases involving sexual health or pregnancy, minors can go to their local health department to seek confidential treatment that is provided for free, Marucci-Bosley said, even if they are covered by their parents' private health insurance. Yet when it comes to giving minors the HPV vaccine, she was not so certain about her legal authority.

"As a clinician, before I would do that, I would want to have it in writing because that is such a sticky wicket," she said.

As the manager of the vaccine program, Reed would be in charge of providing HPV vaccine to health departments that would treat teens under the minor consent law but was also uncertain about its application to this vaccine.

"I am not aware of any official interpretation of the minor consent law [that would allow vaccination]," he said. "It would have to come from the Department of Health and Mental Hygiene attorney general's office."

To a situation in which communication gaps between health officials and doctors, and between doctors and patients, play such a prominent role can now be added communication gaps among health officials themselves. In an email provided by a Department of Health and Mental Hygiene representative, DHMH Assistant Attorney General Kathleen Ellis wrote, "According to the CDC, HPV is a sexually transmitted disease. The vaccination is a preventive treatment for that disease. And the minor consent statute (section 20-102(c)(3) of the Health-General Article) allows minors to consent to that preventive treatment."

This interpretation had never made its way to the Carroll County Health Department.

"I consider myself fairly well versed in the minor consent law and that I do not know for a fact if I can give this [vaccine] under the minor consent law, is a problem," Marucci-Bosley said. "The fact that Greg Reed is not aware of it and he is the one that supplies our vaccine, that's concerning."

In a general sense, this is a well-understood problem, and the DHMH recognizes that in order to best address HPV vaccination, the entire department and all its health care partners need to work together to get a handle on the problem and make directed changes to find a solution, according to Reed, who said efforts are underway to change the status quo.

"What we have done under the direction of Secretary Sharfstein is put together a DHMH-wide HPV task force," he said. "We are bringing in all the programs in DHMH to get a seat at the table to see how HPV impacts our individual programs.

"Moving forward, our Maryland Medicaid program will begin looking at [health effectiveness data] measures for HPV vaccination starting in 2015," Reed said.

Ultimately, Reed said, the goal is to get the word out in every way possible that this is a vaccine that can save lives — a message that should be heard in doctor's offices, in public health departments and in every Maryland home.

"I am a parent. I have two daughters," he said. "I want to make sure they are protected, that they get covered."

Reach staff writer Jon Kelvey at 410-857-3317 or at jon.kelvey@carrollcountytimes.com.

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