- The Washington Times - Saturday, March 17, 2007

Merck’s campaign to mandate Gardasil vaccination of pre-teen girls notched its first two victories in February in Texas and Virginia. Five states are moving on bills similar to Virginia’s mandate. And several states have agreed to provide young female residents free inoculations with the vaccine that targets four strains of Human Papillomavirus (HPV).

Curiously absent from the debate in Virginia’s General Assembly was… well… debate. Few, anywhere, have suggested Gardasil is a product no one really needs, at any price, much less the $360 base price, plus another $180 or more for three office visits and doctors’ fees.

The synchronized nationwide barrage of more than 30 state bills, supported by Merck’s multimillion-dollar TV ad blitz, should have raised curiosity about the appearance of urgency. Merck’s message was ominous: HPV will infect 75 percent of sexually active U.S. women in their lifetime. Some strains of HPV cause cervical cancer, the “second-most common cancer worldwide.” Gardasil “may help prevent” two strains of HPV which together account for 70 percent of cervical cancers.

While technically true, these statistics on HPV and cancer prevalence are more deceptive than relevant. There is an HPV epidemic: About 25 million American women age 14-59 are currently infected with HPV, according to research published last month in the Journal of the American Medical Association (Feb. 27).

But being infected with HPV does not mean one will get cervical cancer, much less die from it. Most strains of HPV are eliminated by one’s immune system — 70 percent are cleared within one year and 91 percent within two years. That leaves only about 10 percent of women infected with HPV who will develop persistent infections. It typically takes 10 to 15 years for a persistent infection to develop into invasive cervical cancer. Pap tests in that period can detect and eliminate precancerous cells before they develop into cancer and invade healthy tissue.

Thanks to high levels of screening in the United States cervical cancer ranked only 13th in cancer prevalence among women and only 12th in cancer mortalities in 2002. Since 1955, U.S. deaths from cervical cancer have fallen 74 percent. Newer tests — a liquid-based Pap test and an HPV DNA test —now deliver even greater accuracy for early detection and treatment.

“Fewer than one-hundredth of 1 percent of the 108 million U.S. women older than 18 (0.009 percent) get cervical cancer and even fewer die from it,” according to Dr. Mona Saraiya, a medical epidemiologist in the Centers for Disease Control’s Division of Cancer Prevention and Control (in G. Lopes and C.M. Dolan, “Cancer-virus vaccine targets wrong age group,” The Washington Times, Feb. 21, Page A1).

The American Cancer Society reports: “Nearly all cases can be prevented if a woman is screened regularly. … When detected at an early stage, invasive cervical cancer is one of the most successfully treated cancers with a 5-year survival rate of 92 percent for localized cancers.”

Lack of screening is the single most important risk factor for cervical cancer. About half of U.S. cases occur among women never screened, and another 10 percent occur in women not screened in five years. By increasing access to Pap tests to the relatively small population of women not now screened regularly, cervical cancer can be virtually eliminated. So who needs Gardasil?

Apparently Merck does, having taken losses from claims relating to Vioxx (cardiovascular risks) and Fosamax (decaying jaw bones), and from generic rivals to Zocor. Merck will also face competition from GlaxoSmithKline’s rival HPV vaccine which could be approved in the next year.

Here are a few other reasons why Gardasil is a pig in a poke:

The JAMA article (above) states: Only 2.3 percent of women are infected with one of the two cancer-related strains of HPV targeted by Gardasil.

Continued regular screening for cervical cancer is essential, even after vaccination.

Because most cervical cancers are diagnosed among women in their late 30s and 40s, vaccinating girls aged 9 to 12 may not even protect them when they are exposed to persistent HPV strains in their early to mid-20s. Merck has not tested Gardasil long enough to know if it’s effective beyond five years. Like other vaccines, Gardasil may require booster shots every five or 10 years. Ka-ching.

As with any pig in a poke, state and individual purchasers of Gardasil will end up paying a lot for something that’s worth very little. But in defense of pigs in pokes, the nonporcine animal in the bag that was sold as a pig probably never caused health problems for consumers. The same cannot be said for Gardasil.

In Merck trials, the incidence of arthritis among those given Gardasil was threefold that of the placebo group. Vaccine Adverse Event Reports (VAERs) show: “There were twice as many children collapsing and 4 times as many children experiencing tingling, numbness and loss of sensation after getting a Gardasil vaccination compared to those getting a Tdap (tetanus-diptheria-acellular pertussis) vaccination. There have been reports of facial paralysis and Guillain-Barre Syndrome,” a disorder in which the body’s immune system attacks part of the peripheral nervous system, according to the National Vaccine Information Center.

Food and Drug Administration staff voiced two additional concerns: Vaccinating girls already infected with one of the four Gardasil-targeted strains could worsen their infection. And with Gardasil suppressing only four strains of the 30 or so sexually transmitted HPV strains, the others could grow in prevalence and severity, offsetting any benefit from Gardasil.

It’s time for lawmakers to shine some light into that “poke” and see what’s being sold to them at such a hefty price tag.

SUSAN WILLS

Mrs. Wills’ opinions herein are her own and not necessarily those of her employer, the U.S. Conference of Catholic Bishops’ Secretariat for Pro-Life Activities.

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