HPV vaccine showing good results in first year

For women, a new vaccine promises to not only prevent the human papilloma virus, known as HPV,… For women, a new vaccine promises to not only prevent the human papilloma virus, known as HPV, but also prevent the harmful side effect of the virus-cervical cancer.

Gardasil, on the market since summer 2006, seems like a miracle treatment, but the vaccine has caused controversy and raised issues ever since it was introduced.

HPV is a sexually transmitted disease. There are more than 100 different strains of HPV, all of which are easily transmitted and virtually undetectable.

HPV can be passed easily through any kind of genital contact – not only sexual intercourse. HPV usually has no signs or symptoms, so people pass it to their partners completely unaware that they are doing so.

The good news is that for most women, the virus goes away on its own.

Your body can fight it off like it would fight a cold, according to Melanie Gold, a professor in the School of Medicine and the Graduate School of Public Health.

The bad news is that when it doesn’t, the virus lingers to cause genital warts or abnormal cervical cell growth – a precursor to cervical cancer.

There is no cure for HPV, but Gardasil, produced by Merck ‘ Co. Inc., is a preventative measure.

Recommended by the Advisory Committee on Immunization Practices in June 2006, Gardasil is the only vaccine that protects against HPV.

The vaccine is designed to protect against the four most virulent strains of HPV: types 16 and 18, which cause 70 percent of cervical cancer, and types six and 11, which cause 90 percent of genital warts.

It does not guard against the more than 96 other strains.

HPV is running rampant among young people.

Of the 6 million new cases of HPV in the United States every year, it is estimated that 74 percent of them occur in 15- to 24-year-olds, according to statistics from Merck.

“I see it all the time, it’s the No. 1 most common sexually transmitted infection,” Gold said. “Most of the time, adolescents come in and don’t even know they have it. They’re here for their yearly exam, and I have to point it out to them.”

The Centers for Disease Control and Prevention estimated in 2005 that at least 50 percent of sexually active people catch some strain of HPV during their lifetime.

Eighty percent of them defeat it on their own, Gold said.

“If you have a healthy immune system, there’s no reason to worry right away [about cervical cancer]. Cervical cells change very slowly, and women can clear it on their own, particularly those in their first few years of sexual activity,” Gold said.

“There’s no reason to panic because cervical cancer doesn’t develop quickly.”

What was once the leading cause of cancer death for women in the United States is one of the most preventable, according to the CDC and Gold.

And, because of the increasing use of the Papanicolaou, or Pap, test to detect abnormal cervical cell growth, both incidence and mortality rates are down.

According to the Gardasil fact sheet, “About half of all females diagnosed with cervical cancer are between the ages of 35 and 55 years old. These women were most likely exposed to one of the high-risk types of HPV during their teens or 20s.”

Then they neglected Pap tests for years, while the cancer multiplied and spread. Regular Pap tests, Gold said, would have caught most of those cases.

Merck has distributed more than 10 million doses of Gardasil worldwide since June 2006, according to their website, despite some of the negative connotations associated with it.

For one thing, it requires a carefully coordinated schedule.

The vaccine is administered in a three-shot series. The second shot is given two months after the first and the final is administered four months after that (a six month process in total).

Merck recommends that all three doses be received in order to gain the full benefits of Gardasil.

This timetable can be tricky to plan, especially for young women attending college away from home.

Missing a shot is probably not a big deal, said a nurse at Pitt’s Office of Student Health, but the CDC cannot offer information about how this would influence the efficacy of the vaccine just yet.

Currently, said Gold, studies are in progress concerning older age groups, variations in the dosage schedule and the vaccine’s effect on men.

Planning to cover the cost can be even trickier.

Each dose costs $136, according to Student Health, and women need three.

The cost of the vaccine is not covered by the student health plan, so anyone who gets vaccinated at Pitt can expect to pay $408 for the shots.

What about insurance coverage?

“The vaccine is recommended but not yet required,” Student Health’s Kathy Guliano said. “Insurance companies don’t always cover it because they don’t have to. Every plan that each company offers has different qualifications so you need to call your plan and check with them.”

Many plans, she said, will cover the costs if the recipient is of a certain age, usually up until 20 or 21 years old.

Other plans have different restrictions on them as well.

Boeing Blue Cross Blue Shield traditional medical plan, for example, offers full coverage but only if the recipient gets the shots from one of the doctors approved by the plan.

Other plans have limits on the monetary amount provided for preventative care, the category that covers vaccines.

While they may provide an annual sum to cover the cost of vaccinations or doctors’ visits, that coverage limit often cannot stretch to cover the complete cost of the Gardasil vaccine – it may be able to pay for only one or two of the shots.

Every insurance company will have some sort of catch, Guliano warned.

Merck provides a helpful question list on its website for dealing with individual health plans.

These questions can help the patient ascertain just how much this vaccine will cost them.

The list echoes Guliano’s concerns but also stresses that coverage can change over time, so it’s important to make this call prior to each of the three required visits.

There are also programs that can help cover the cost for the uninsured.

The Vaccines for Children program is a federally funded program that “removes vaccine cost as a barrier to immunization,” Harryl Allen, the program’s director, said.

Vaccines that are recommended by the ACIP and approved by the CDC, like Gardasil, are administered to children 18 and younger who meet at least one of the following criteria, according to Allen: are eligible for medical assistance, are without any health insurance, are Native Americans or Alaskan Natives or have health insurance which does not cover immunizations.

“The VFC program saves parents and enrolled providers more than $600 per child in out-of-pocket expenses for vaccine,” Allen said, because vaccines are purchased at the lower federal contract price and then distributed to private providers to administer to eligible children. The goal, Allen said, is to try to stop the spread of vaccine-preventable diseases.

Some have raised moral objections to providing Gardasil to young women, especially minors.

“There’s the idea that if you give children something to prevent cervical cancer, it will cause them to go out and have wild, rampant sex,” Gold said. “It’s ridiculous.”

Gold noted that Hepatitis B is another sexually transmitted disease with serious repercussions for which a vaccine is required by the state – she sees no difference between them.

“We also know that the immune system has a better response when you’re younger,” she said. “The vaccine is much, much better at promoting an immune response when given to someone who is 13 or 14 as opposed to a 19- or 20-year-old.”