Guarded about Gardasil?

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on May 14, 2009 at 8:00 AM, updated May 14, 2009 at 8:15 AM
Renee Heyden and her teenage daughter, Stephanie.

When she was 23, Sharon Capp was diagnosed with a form of human papillomavirus. That's also when she learned that HPV, a sexually transmitted disease, can cause genital warts, cervical cancer and create cervical abnormalities that sometimes lead to cancer.

Although Capp's doctor removed her precancerous cells with laser surgery, the feeling of shame and fear persisted. Only when news of an HPV epidemic came out a few years ago could Capp, a resident of Middletown Twp., feel "honestly relieved" to be one of many.

So, recently, after hearing a television commercial about Gardasil, a vaccine developed to prevent four types of HPV, Capp didn't hesitate to have her two daughters, now 18 and 16, vaccinated. "I did a little research on the Internet, in addition to the documents my doctor provided," she said. "I had no qualms at all about the vaccination. Having a part in protecting my daughters without any risk gives me a sense of relief."

Ideally, the vaccine -- approved by the FDA for females ages 9 to 26 -- should be given to girls and women before they ever become sexually active.

Although cervical cancer is far less common than breast cancer, it's still a "biggie," said Dr. Richard Blutstein of Pennsboro Pediatrics in Enola. According to the National Cancer Institute, there were 11,150 new cases of cervical cancer in 2007 -- and 3,670 of those women died.

"The main argument in favor of Gardasil is that it works," said Blutstein. "Gardasil is the first vaccine that can actually prevent cancer. It protects against the two most common types (16 and 18) of HPV that cause cervical cancer as well as the two most common types (6 and 11) that cause genital warts."

The vaccine has limitations. Gardasil doesn't prevent all types of cervical cancer and may not protect everyone, so it's important for women to continue getting a regular cervical cancer screening (or Pap smear). However, anyone who's allergic to the ingredients of Gardasil shouldn't receive the vaccine. Nor should pregnant women.

Gardasil won't treat existing cervical cancer or genital warts and won't protect against diseases caused by other HPV types. It also doesn't protect girls or women who have already been exposed to the four types of HPV the vaccine was designed for. The treatment also has side effects. The most common are pain, swelling, itching and redness at the injection site, fever, nausea and dizziness.

But for some families, cost may be a greater impediment, Blutstein points out. Gardasil is administered in three doses over a six-month period, at a cost of $120 per injection, or $360 for the series. That doesn't include the cost of administering the vaccine.

Insurance coverage is uneven. Medical Assistance, for example, does cover Gardasil, but individual health care plans may choose whether to cover vaccinations or not. "If they do, they have to cover all of those recommended by the Centers for Disease Control, which publishes guidelines every six months that do include Gardasil," Blutstein said.

Some employers don't provide insurance at all, while others self-insure, with their plans administered by an insurance company. "These employers can pick and choose," Blutstein said. "The insurance company may cover Gardasil, but the employer's plan administered by it may not. You can't assume Gardasil will be covered. You have to call and ask."

Another concern is that Gardasil may offer a false sense of security -- in that girls and women may think they no longer need Pap smears if they've been vaccinated. "Because of the 25 to 30 percent of cases of cervical cancer that won't be prevented with the vaccine, It is our job of health care providers to make sure patients understand they still need regular Pap smears," said Dr. Margaret Grotzinger, practicing with Partners in Women's Healthcare since 1989 (just gynecology since 2000).

In fact, some question the money spent on vaccinating all women, since cervical cancer isn't that common and can be prevented through regular Pap smears. It's true, said Grotzinger, that most women who develop cervical cancer haven't had a Pap smear in five to 10 years or more. Cervical cancers are generally slow-growing tumors, so if a woman does have regular Pap smears, her chances of actually developing cervical cancer are extremely low.

Still, she recommends Gardasil. "My answer is that HPV infection is rampant in our society," Grotzinger said. "More than 50 percent of college-age girls are infected at some point. For those who are, we have no way of telling who will clear it and who won't, who will develop precancerous cells and who will develop cancer. So we're obligated to follow closely all those women who have been exposed to HPV. Gardasil markedly decreases the volume of women who need to be monitored and treated for abnormal Pap smears."

That means more than financial expense. One of the biggest "costs" in treatment is the emotional trauma of being diagnosed with HPV and the anxiety that comes with subsequent monitoring and treatment. "Plus, treatment can impact a woman's ability to carry a pregnancy in the future, especially if multiple treatments are required," Grotzinger said.

One objection to Gardasil is attitudinal rather than medical. "Some people believe that vaccinating against a STD will encourage premarital sex," Blutstein said. "But there's no evidence at all to support that."

Renee Heyden of Lower Paxton Township was aware of the attitude but chose to have both her daughters vaccinated. "My reasoning is that currently Gardasil is the only agent available to prevent them from getting the high-risk type of HPV shown to be a cause of cervical cancer," said Heyden, a certified physician assistant specializing in the OB-GYN field. "I realize that it is transmitted sexually, and I am not advocating premarital sex. However, in today's world I'd be a fool to hide my head under the covers. I'm protecting my daughters."

It's been advocated that Gardasil be required like some other vaccinations. But Blutstein and Grotzinger have found that patients are generally receptive once they know about the link between HPV and cervical cancer.

Vaccinating doesn't mean a lesser need to educate patients. Women at risk for sexually transmitted diseases-and cervical cancer -- are usually women who have had multiple partners. But even if a woman has only one partner, if that partner has been with five other women, it's the same as if she had five other partners.

"This is an important point to stress to young girls and teens," Grotzinger cautioned. "They may think they're being careful by having only one partner, but if he has been with many other women, they're putting themselves at major risk. This is especially true because most men have no signs or symptoms of HPV. They don't know they're harboring and transmitting the virus."

That's why some in the medical community favor extending Gardasil to males. "Given that men transmit the virus, most of the time unknowingly, it's my hope that the CDC recommendation in the near future will be to vaccinate boys as well," Grotzinger said.

For Renee Heyden, the decision to vaccinate is part of sound parenting. "I love my girls more than life itself and will do whatever's possible within my reach to protect them from illness," she said. "As a mother, this is my responsibility."

Questions and answers about vaccine

To protect against four types of human papilloma virus or HPV, the Food and Drug Administration has licensed Gardasil vaccine for girls and women ages 9 to 26. The vaccine is given through a series of three shots. The vaccine protects against four HPV types, which together cause 70 percent of cervical cancers and 90 percent of genital warts. The retail price of the vaccine is $120 per dose.

Here a few of the common questions about HPV and the Gardasil vaccine:

What is HPV?
Human papillomavirus is the name of a group of viruses that includes more than 100 different strains or types. More than 30 of these viruses are sexually transmitted, and they can infect the genital area of men and women. Most people who become infected with HPV will not have any symptoms and will clear the infection on their own.

How common is it?
About 20 million people are infected right now with HPV as at least 50 percent of sexually active men and women acquire genital HPV infection at some point in their lives. About 6.2 million Americans get a new genital HPV infection each year.

What is the connection between HPV infection and cervical cancer?
About 10 of 30 identified genital HPV types can lead, in rare case, to development of cervical cancer. A Pap test can detect pre-cancerous and cancerous cells on the cervix. Most women who develop invasive cervical cancer have not had regular cervical cancer screening.

Who should get the Gardasil vaccine?
Females should get the vaccine before they are sexually active. This is because the vaccine is most effective in girls and women who have not yet acquired any of the four HPV types covered by the vaccine. It is recommended for 11-12-year-old girls, and can be given to girls as young as 9. The vaccine is also recommended for 13-26 year-old girls and women who have not yet received or completed the vaccine series.

What about vaccinating boys?

What does the vaccine not protect against?
• The vaccine was less effective in young women who had already been exposed to one of the HPV types covered by the vaccine.

• This vaccine does not treat existing HPV infections, genital warts, precancers or cancers.


The length of vaccine protection or immunity is usually not known when a vaccine is first introduced. So far, studies have followed women for five years and found that women are still protected.