Gardasil – Hope or Hype?

As my oldest daughter, Lena, moves out of childhood and into adolescence, her dad and I are plagued with so many new dilemmas. She, like all 12-year-olds, would like more privileges and wants us to trust her to make more of her own decisions. These things slip in and out of our daily conversation pretty easily now. We discuss, resolve and move on.

Then there are the bigger issues regarding Lena’s growth that have just sort of woven themselves into the fabric of our lives, changing our interaction slightly while we learn about the woman she’s becoming. These issues largely revolve around her health and emerging sexuality. At 12, she’s noticing boys. She’s picking clothes that make her look cute and gazing in the mirror, trying to figure out who she is. We are gazing back at her, watching our baby grow up.

While these developments have been in the forefront in our home, the backdrop for young women all over the country has been altered. There is a new vaccine that prevents HPV (human papillomavirus), one of the major causes of cervical cancer in sexually active women. I decided to do some research about this vaccine after Merck (the manufacturer of Gardasil) recommended it be given to girls as young as 9, meaning I have not one, but two daughters who are prime candidates for receiving it. What I learned while I was digging around was interesting, to say the least.

In the convincing ad campaign for the vaccine, young street-wise beauties from all walks of life look the television audience straight in the eye and talk about taking their health into their own hands. In place of the sing-song jingle so common in pharmaceutical commercials (as in, “Gotta go, gotta go, gotta go right now” ) , there is an infectious, urban chant proclaiming that recipients of the vaccine will be “One Less, One Less” victim of cervical cancer.

Did you know?

There are over 100 strains of HPV, and about 30 of them are sexually transmitted. Other strains cause warts on the hands and feet, or occur asymptomatically. Nearly 75 percent of Americans will contract HPV before their 50th birthdays. Most cases of HPV need no treatment and will resolve on their own without any problems. Of the 30 sexually transmitted strains, about 14 are considered high risk, meaning they have the potential to mutate into precancerous lesions on the cervix. Not all precancerous lesions will become cervical cancer, however. Many will also disappear on their own.

Gardasil protects against four strains of sexually transmitted HPV. Two of them are low-risk strains, causing visible genital warts but not presenting any real danger. The other two are high-risk strains, meaning that if they went untreated, they might become precancerous. According to the studies done before the vaccine was released, Gardasil is about 70 percent effective in preventing these four strains of HPV in women who have never had those particular strains before.

Gardasil is a three-injection series to be given within a six-month timeframe with a total cost of $360. There is evidence that protection lasts five years, but because the drug is so new, it is not known whether boosters will be needed later.

It’s important to note that while untreated HPV is one leading cause of cervical cancer, there are other causes as well. According to the Mayo Clinic’s website, smoking, HIV infection, Chlamydia infection, long-term use of birth control pills, multiple pregnancies, being overweight and a family history of cervical cancer are important risk factors. It’s even possible, though rare, for women who haven’t had sex to develop cervical cancer. This is why it is important for all women to have regular pap smears.

The politics of protection

Gardasil, which has been inaccurately labeled the Cervical Cancer Vaccine, has garnered much attention in political arenas. On the surface an undeniably popular cause to support (who could be in favor of cervical cancer, after all?), legislators all over the country jumped on the Gardasil bandwagon with unprecedented, and to many, surprising, speed and force. As of mid-February 2007, just seven months after its release date, 34 states had pending legislation regarding the vaccine. Some states were attempting to mandate the vaccine to preteen girls, others wanted to provide education to those same young women, and still others wanted to require private insurance to pay for this very expensive vaccination.

In Texas, the governor issued an executive order mandating the vaccine for all girls entering sixth grade by the 2008-2009 school year, and the public outcry was audible all over America. A few months later, through due legislative process, the executive order was overturned in a law that stated that the vaccine could not be required by law. Thankfully, heels have since similarly cooled around the country, and Gardasil has taken its place in the queue of important matters of state. As of the writing of this column, only 16 states still have legislation pending and most initiatives to make the vaccine mandatory have failed.

Because this vaccine protects against HPV in the hopes of preventing cervical cancer, it seems to make sense that it is a vaccine for women. However, men contract sexually transmitted HPV at identical rates to women and transfer it through the same methods. It can be asymptomatic in men, just as it is in women. If the real goal is to severely reduce the numbers of HPV, and thus reduce the risk of cervical cancer in women, why is the vaccine not being given to men as well?

Phase I of testing on women began in 1995, and Gardasil is only now being tested on men, with results not expected until sometime in 2008. To many pro-woman activists, this smacks of the same gender politics that allowed insurance companies to pay for Viagra immediately after its introduction in 1998 while refusing to pay for prescription contraceptives for women. As of January of this year, only 26 states required insurance companies to pay for the pill and other forms of contraception. As this vaccine is being pushed heavily on girls as young as 9 years old, I worry that it reinforces the age-old, societal-wide, sexual myth that men don’t need to take responsibility for their actions and women will clean up any resulting messes.

The safety

The methods used by Merck during the trials for Gardasil have also come under scrutiny from vaccine safety watch groups. NVIC (National Vaccine Information Center) reports that the FDA allowed Merck to use a base for the placebo that included aluminum, which can cause its own set of reactions, instead of using the industry standard of a non-reactive placebo such as saline solution. This allowed the number of adverse reactions to the vaccine to be much closer to the number of similar reactions to the placebo.

According to the NVIC, “Nearly 90 percent of Gardasil recipients and 85 percent of aluminum placebo recipients followed-up for safety reported one or more adverse events within 15 days of vaccination, particularly at the injection site.” Reported severe reactions included one case of juvenile arthritis, two cases of rheumatoid arthritis, five cases of arthritis, and one case of reactive arthritis out of 11,813 Gardasil recipients, and one case of lupus and two cases of arthritis out of 9,701 participants primarily receiving the placebo containing aluminum. To further illustrate the connection between the reactive placebo and the vaccine itself, about 60 percent of those who got either Gardasil or the aluminum placebo experienced headache, fever, nausea, dizziness, vomiting, diarrhea or myalgia.

There seems to be even more potential for adverse reactions from the vaccine itself, including gastroenteritis, appendicitis, pelvic inflammatory disease, asthma, bronchospasm and the afore-mentioned arthritis. And as serious as these fast-manifesting side effects are, it’s also important to remember that long term safety can’t yet be known due to the newness of the vaccine.

In the end

As I worked through the stacks of information about Gardasil, I was glad that my own parents taught me the skills I needed to perform my own research and the strength to make my own decisions, even in the face of a really good advertising campaign. My daughters will not be receiving this vaccine while they live at home. What they will receive instead is solid information about HPV and other sexually transmitted diseases and, hopefully, their own ability to gather information and make their own decisions as adults. We’ll start practicing with clothes and privileges and go from there. VS