A Shot Against Cervical Cancer
A stunning new youth vaccine promises to prevent the deadly disease—but will parents go for it?

by Mary Jane Horton

Believe it or not, a new vaccination, speeding down the pike, has the potential to nearly eradicate cervical cancer in our lifetime.

The health profession has already scored a huge victory against the disease: Between 1955 and 1992, the number of cervical-cancer cases dropped by 74 percent due to increased use of the Pap smear, according to the American Cancer Society (ACS). And yet, ACS estimates that in 2005 about 10,370 cases of invasive cervical cancer—that which spreads outside the cervix—will still be diagnosed in this country, claiming the lives of over 3,700 women.

Further, researchers estimate that noninvasive cervical cancer rates are four times as common as the invasive type. Worldwide, the numbers are even higher. According to the World Health Organization there are nearly 500,000 new cases of cervical cancer every year. While diagnostic breakthroughs have certainly helped, cervical cancer is still the fifth leading cause of death from cancer in women, with most of the cancers occurring in women who have never had a Pap smear.

The “magic bullet” on the horizon is a vaccination for human papillomavirus (HPV), a sexually transmitted virus which not only causes genital warts but is the leading cause of cervical cancer. “HPV is actually a family of about 100 viruses that can affect a woman’s reproductive tract,” says Francisco Garcia, M.D., associate professor of obstetrics and gynecology and director of the Women’s Health and Resource Center at the University of Arizona, Tucson. “Most of our bodies recognize it and get rid of it—80 percent of sexually active people have been exposed. In a small minority of women, the virus gets into the cells of the cervix, causing a precancerous condition that can turn into cancer.” In addition to causing cancer, the virus is also responsible for abnormal Paps, which are financially and emotionally costly for thousands of women each year.

The vaccinations now being developed by GlaxoSmithKline (GSK) and Merck, Sharp & Dohme (the U.K. subsidiary of the U.S. pharmaceutical company Merck) may be available as soon as spring 2006. They’re in Stage III clinical trials—the last stage before they are released. GSK plans to file for regulatory approval of
its vaccine in Europe, probably sometime this year, and Merck plans to file for licensure with the FDA in the second
half of 2005.

Targeting HPV

The GSK vaccine targets HPV types 16 and 18—which cause cancer—and
the Merck vaccine adds in genitalwart- causing types 6 and 11. In clinical trials thus far, both vaccines have been shown to be safe and effective,with no major side effects besides soreness at the vaccination site. Experts predict the vaccines could prevent development of up to 70 percent of cervical cancers worldwide.

“This is the first real advance in women’s medical care in 50 years,” claims Diane Harper, M.D., MPH, associate professor of obstetrics and gynecology at Dartmouth Medical School in Hanover, N.H. She is lead researcher for the GSK vaccine and a member of the Merck research team. “It will really change the way our daughters and granddaughters are cared for. This happened so fast: It was only 30 years ago that we figured out cervical cancer is caused by HPV and now we have a vaccine.”

The first vaccines on the market will be prophylactic—given to young girls, and perhaps boys, before they become sexually active. The main reason to vaccinate boys, who can carry the virus asymptomatically and pass it along, is for the “herd immunity effect,” which protects a much larger part of the population. HPV can also cause penile and anal cancers. The second vaccine track, “which is further down the line,” says Garcia, will be designed for women who already have precancerous conditions.

One roadblock to wide implementation of the HPV vaccine is monetary: It will be expensive, perhaps costing up to $300. “If this is strictly a vaccination provided to people who can pay, then its cancer protection will be minimal,” says Harper, reiterating that the highest risk groups are those who don’t even get Pap screenings and often can’t afford a pricey preventative.

Controversy—or a no-brainer?

Once the FDA approves the vaccination, the hard part starts: convincing mothers and fathers to take their 8- to 13-year-olds (the estimated starting ages for the three-vaccination protocol) to be vaccinated for a sexually transmitted disease. Will some believe the vaccine will invite early sexual activity?

“Most of us in public health wonder why this should be controversial,” says Beth Jordan, M.D., medical director of the Association of Reproductive Health Professionals and the Feminist Majority Foundation. “It relates to young women and sex, and so often we see science being held hostage to women’s sexuality. If this was something that had to do with men and sex, it would be a no-brainer.”

I ask myself, would I give my precious 12-year-old daughter—many years away from beginning sexual activity, I hope—a vaccination for an STD? My answer is, yes, of course, because it means protecting her against cancer for decades into the future. But, sadly, I may be in the minority.

In anticipation of FDA approval, polling of parents’ attitudes toward the vaccines has begun. In an Internet based survey of 2,050 parents of female adolescents between 9 and 17 years old, Merck found that 71 percent were unaware of the connection between HPV and cervical cancer. When they were educated about the virus, 62 percent said they would vaccinate their daughters before their 18th birthday, if a vaccine were available. Most of the other respondents were unsure of what they’d decide to do.

Another recent poll, published in the Journal of Lower Genital Tract Disease, surveyed 575 parents or guardians of 10- to 15-year-olds, finding that the 24 percent who opposed the vaccinations did so because they felt it would promote early sexual activity. A third study, presented at a March meeting of the Society of Gynecologic Oncologists, polled 200 women from Galveston, Texas. It found that 76 percent of women surveyed would be willing to accept a cervical-cancer vaccine for themselves, 67 percent for their daughters and 64 percent for their sons.

Experts feel that the way the vaccination is promoted will be crucial to its acceptance. “It will be easiest to implement the HPV vaccine as part of a platform of adolescent vaccines,” says Dartmouth’s Harper. She predicts it will be combined with vaccines for meningitis and other ailments that are geared toward adolescents in the 8- to 13-year-old range. She’s also hopeful that if the vaccination is earmarked for cancer prevention—and the aspect of sexually transmitted disease downplayed—parents will be supportive.

“The devil is in the details,” agrees the University of Arizona’s Garcia. “I am worried about a very conservative, abstinence-only culture that will politicize this. We need to have a national dialogue and educational campaign about how important it is.”