An ounce of prevention

It was about four years ago that Seo Hee Won was diagnosed with HPV, or human papillomavirus. She didn’t know the sexually transmitted virus was directly linked to cervical cancer.

“I was like, ‘What the heck is that?’” she remembered. “They’re like, ‘Don’t worry.’”

Seo, a graphic designer who lives in Minneapolis, was told that her Pap smear had revealed ASCUS—Atypical Squamous Cells of Undetermined Significance— but not what that meant.

“The most hilarious acronym I’ve heard of,” Seo said.

Hilarious—and worrisome. So she went online and found more about HPV than her medical caregivers were willing to tell her. “I did a lot of my own web research and figured out HPV is related to cervical cancer,” she said. “[I had] only heard about the genital warts. I’d never heard of it being linked to cancer.

“I had to ask about why most women who have HPV have precancerous cells. It felt like the runaround. I’m sure the nurses were annoyed with me.”

Though it’s been only a few years, a lot has changed since Seo learned she had HPV. A clear link between HPV and cervical cancer has been established, in large part due to research conducted about 15 years ago at the University of Queensland in Australia. The human papillomavirus is very common—some estimates suggest that 80 percent of adults (both men and women) over age 40 have had it at some point. Most show no symptoms, and the virus clears up on its own, but in thousands of cases each year, it causes cancer.

The disease is also in the headlines more often, including a new barrage of television commercials by vaccine maker Merck explaining how the vaccine can protect women and girls from the most common strains of HPV—and cervical cancer—if administered before they become infected. A similar vaccine from a second company is not far behind. However, questions remain. Probably the most urgent of these is whether the women who most need the vaccine will be able to get it.

What the vaccine does

Merck, a New Jersey-based pharmaceutical giant, received approval from the FDA to market Gardasil in June, and the vaccine is expected to be available later this summer to girls through their pediatricians and primary care doctors. The vaccine is administered in three doses over six months, and each shot costs $120, for a total of $360.

GlaxoSmithKline’s HPV vaccine, Cervarix, is still being developed and could take months or even a couple of years to get to the market.

Cheryl Bailey, a gynecological oncologist in Minneapolis, is thrilled with the new vaccine because it will help combat the effects of HPV in women—not just cancer, but dysplasia, an abnormality in the cells of the vagina, cervix or vulva that sometimes leads to cancer.

“I think it’s awesome,” she said. “In the U.S., it’ll save a lot of nuisance. We have about 4,000 deaths a year from cervical cancer, but we have tons of dysplasia—which is very costly in terms of biopsies, co-pays, time away from work—so if all of our cervical dysplasia gets eradicated, that’s really going to be nice for people.”

Bailey’s enthusiasm is tempered, however, by the fact that the vaccine is effective against only four strains of the 100 or so common strains of HPV (numbers 16 and 18, which cause about 70 percent of cervical cancer cases, and numbers 6 and 11, which are responsible for about 90 percent of genital warts).

“There still is going to be dysplasia because there are so many HPV types,” she said.

Even more serious, she believes, is the very real possibility that the women (or girls) who need the vaccine the most won’t be able to afford it.

In the online news magazine Slate, writer Arthur Allen pointed out, “Most of the 14,000 cases of cervical cancer in 2004 in the United States occurred in women who hadn’t had a Pap smear in three years or more. If all women were screened regularly, we wouldn’t need a vaccine.”

Those who do get the new HPV vaccine will likely be those who regularly get Pap tests and those who have the medical and financial resources to get treatment if something goes wrong.

What about girls without insurance, Bailey asks—or girls in poor countries?

“The number of deaths from cervical cancer worldwide is enormous,” she said. “That’s the big issue with cost, is Third World countries not having enough money for basic sanitation, not to mention a shot three times. Women don’t even get to go to school, much less get medical care. We know that clean water and mosquito tents work [to prevent] malaria, but that doesn’t mean people have [them]. And that doesn’t cost $300 per person.”

It’s estimated that as many as 300,000 women around the globe die from cervical cancer every year.

Pap tests still necessary

Kristen Suthers, a policy specialist at the National Women’s Health Network, a national, membership-based organization that promotes and performs critical analyses of health policy issues, agreed that the girls who need it most might not have access to the vaccine.

“The primary population is women who lack resources,” she said. “They would be most likely to get cervical cancer because they can’t get Pap smears, so having a vaccine would be most helpful. Our fear is that they won’t be the target population because they won’t be able to afford the vaccine if they have to pay out of pocket for it.”

As for girls who do get vaccinated, Suthers hopes they’ll understand that they still need regular screening for cancer and other abnormalities. “Our constant message is all women still need Pap smears,” she said. “[The vaccine] reduces your risk, but it’s not foolproof. It’s really important to emphasize that—it doesn’t protect you against all the strains of HPV.”

The vaccine also doesn’t protect against other types of sexually transmitted diseases.

In addition, the vaccine is effective against the virus only if it’s given before the person is infected—which, in practical terms, means before they become sexually active. “The FDA estimates that by age 40, 80 percent of adults will have had some strain of HPV,” said Suthers. “The FDA made the recommendation that women between 9 and 26 get the vaccine—you do need to get the vaccine before exposure for it to work. So before first sexual contact.”

Mandatory vaccinations

In late June, the Centers for Disease Control’s Advisory Committee on Immunization Practices recommended that girls ages 11 and 12 be vaccinated against HVP. While the recommendation isn’t binding, it will likely mean insurance companies will cover the cost of the shots; the panel may also recommend that the federal government include the vaccine among those provided to children free or at reduced cost.

Some people argue that the best way to ensure the vaccine gets to poor and uninsured kids is to make the HPV vaccine mandatory, along with other childhood vaccinations. But some leaders of the Religious Right have expressed opposition to including Gardasil on the list of mandated inoculations required for public school attendance (such as those for diphtheria, mumps, and pertussis), because they say it would send the message that teen sex is OK.

Bailey takes issue with that stance. “I don’t even want to give any time to the controversy,” she said. “I think it’s an awful thing to even consider denying this to kids who might get cervical cancer. It makes no sense to me.”

But other groups also opposed making the vaccine mandatory.

“It’s going to be a political volleyball, no matter what anybody says,” Suthers predicted.

“We haven’t come out with recommendations for whether the shots should be included in school,” she added. “Vaccines, in order for them to work effectively, have to be given to everybody. But you’re never going to eradicate all cervical cancer with this vaccine.”

Suthers has other questions too, including how long the vaccine’s protection will last. But overall, she said, it is a huge step forward. “We were, of course, thrilled.”

Seo also has conflicting feelings—and questions. “I’m glad that there’s a vaccine,” she said. “I hope there’s been enough testing. I’m concerned that the drug company seems to be the one getting the press. It’s good on one hand, but I really do question accessibility—is this something that’s only going to benefit the first world?”

She added: “I’m hoping that more young women think about [HPV] and ask to be tested and be really proactive.”

The benefits of Pap tests

Health experts say the HPV vaccine is not a substitute for a regular Pap test.

• Regular annual Pap tests reduce the incidence of cervical cancer by up to 90 percent.

• The Pap test can detect cervical abnormalities caused by genital HPV.

• Regular Pap tests allow any changes to the cells of the cervix to be identified and managed well before they may become cancerous.

Key information for women about human papillomavirus

• Four out of five women will have HPV at some time in their life.

• Many women have HPV and never know it, as the body’s immune system usually clears the virus in one to two years.

• HPV often has no symptoms, but can sometimes cause genital warts or cervical cell changes.

• Genital HPV is spread by genital skin contact during sexual activity. Condoms offer limited protection as they do not cover all of the genital skin.

• Most women with genital HPV will not develop cervical cancer.


What to know about cervical cancer

Cervical cancer is the second most common cancer among women, and the third most common cancer around the world. It kills close to 4,000 women each year in the United States, and as many as 300,000 women worldwide.

The HPV vaccine

Name: Gardasil

Maker: Merck

What it does: The vaccine has been shown in clinical trials to be 100 percent effective in preventing infection of four common strains of the HPV or human papillomavirus responsible for about 70 percent of cervical cancer cases.

Who it’s for: The FDA approved the sale and marketing of Gardasil to girls and women age 9 to 26. An advisory committee of the Center for Disease Control recommended vaccinating girls ages 11 and 12.

Where it’s available: Later this summer through pediatricians and primary care clinics

How it’s administered: Three shots over six months

The cost: $120 for each shot, or $360 total