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New Shot on the Block
Old 08-09-2006, 06:00 PM   #1
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On June 29, 2006, the national Advisory Committee on Immunization Practices (ACIP) recommended that all 11- and 12-year-old girls be vaccinated with a newly approved vaccine that protects against HPV.

Medical professionals waging war against human papilloma virus—a sexually transmitted disease that is very common among sexually active women—scored a major blow against the disease last month. On June 29, 2006, the national Advisory Committee on Immunization Practices (ACIP) recommended that all 11- and 12-year-old girls be vaccinated with a newly approved vaccine that protects against HPV. The development promises to help curtail the spread of the virus, some strains of which are known to cause cervical cancer. Though several socially conservative groups fear that HPV vaccination could encourage promiscuity, the medical community has hailed the news as a major step forward in the fight against both cancer and STDs.

Sexually Transmitted . . . Cancer?

Human papilloma virus is the most common STD in America; according to some estimates, as many as 20 million people are carriers. There are about 30 different types of sexually transmitted HPV viruses, which cause a wide range of symptoms in their hosts. Some strains of the virus, including type 6 and type 11, can cause genital warts, while others cause no symptoms at all. Some types of HPV, however, are far more ominous. HPV strains such as type 16 or 18 are associated with a variety of cancers, including cancer of the head, neck, penis, anus, vulva and cervix. Cervical cancer, which kills several hundred thousand women worldwide each year, is linked particularly closely with HPV; in fact, infection with the virus is a prerequisite for 70% of all cases of the disease.


Baylor College

Unlike most viruses, cancer-causing strains of HPV have a DNA genome (instead of an RNA one). Because cells replicate DNA only during mitosis, HPV, in order to make copies of itself, must convince its host cell to divide—something mature cervical cells don't normally do. This untimely cell division, combined with a loss of the mechanism to stop dividing, can result in cancer (below).


American Cancer Society/Getty Images

So how does an STD cause cancer? Unlike most viruses, oncogenic (cancer-causing) strains of HPV have a DNA genome (instead of an RNA one). Because cells replicate DNA only during mitosis, HPV, in order to make copies of itself, must convince its host cell to divide—something mature cervical cells don't normally do. This untimely cell division, combined with a loss of the mechanism to stop dividing, can result in cancer. If HPV is unable to infect the cervical cells, however, they never begin inappropriately dividing in the first place. Therefore, an HPV vaccine would not only stop the human papilloma virus from spreading—it would effectively prevent cancer as well.

A Very Effective Vaccine


Jonathan Wood/Getty Images
Ian Fraser, the developer of the vaccine to prevent cervical cancer, works in his laboratory in Brisbane, Australia.

More than a decade ago, Merck & Co., Inc. began developing just such a vaccine. In October 2005, the pharmaceutical company announced that Gardasil—which protects against four HPV strains, including 16 and 18—had passed its phase-three clinical trials with stunning success. Of the roughly 6,000 women who received the vaccine, not a single one developed HPV-related cancer or pre-cancerous cells (as compared to 21 cases of cervical cancer in the control group). Furthermore, none of the women who participated in the study experienced any serious side effects—indicating that Gardasil was both effective and safe.

On June 29, 2006, the ACIP, a CDC advisory panel, unanimously voted that the vaccine should be routinely administered to all preteen girls. Though the panel recommended that girls typically be vaccinated when they're 11 or 12 years old—first, because children already receive other shots at that age, and second, because the vaccine is most effective before women become sexually active—it suggested that women up to age 26 could benefit from the shot. The recommendation is a major step towards providing Gardasil to women around the world. As Mark Feinberg, Merck’s Vice President of Policy, Public Health and Medical Affairs, stated in a press release, "Gardasil was specifically designed to reduce the majority of HPV-related clinical diseases . . . and this recommendation from the ACIP will help ensure that this vaccine can do just that for many girls and young women."

Getting Gardasil Going

Despite the promising developments surrounding the vaccine, several roadblocks remain. As Cynthia Dailard of the Guttmacher Institute, a non-profit dedicated to reproductive health research, told the Associated Press, "This is an incredibly exciting breakthrough, but at the same time, it presents some major challenges . . . the likes of which we have never confronted before." First, there are logistical issues—a single dose of Gardasil must be given as three shots over a six-month period, prompting some officials to worry that patient compliance may be a problem.

Cost is also a concern; each injection rings in at $120, for a whopping total of $360. In an interview with the New York Times, researcher John Schiller, whose work contributed to Gardasil’s discovery, pointed out, "This vaccine will be more expensive than all other childhood vaccines put together." Further complicating the issue is the fact that cervical cancer disproportionately affects the poor, largely because poor women are often unable to get Pap smears to screen for the disease. As Schiller asked the Times, "How do you make sure [the vaccine] gets to the poor women who need it most?"

Other issues surrounding Gardasil stem not from the shot itself, but from the controversy relating to the disease it protects against. Though Merck is marketing the vaccine as a cancer preventative, some conservative groups have focused on the fact that it also prevents STD transmission. Such groups are concerned that HPV vaccination could undermine abstinence campaigns—and encourage sexual promiscuity. According to Linda Klepacki, an analyst at a conservative Christian organization called Focus on the Family, "You can't catch the virus, you have to go out and get it with sexual behavior. We can prevent it by having the best public health method, and that’s not having ѕex before marriage." In an interview with the Associated Press, Klepacki also expressed concern that Gardasil would join the select circle of required vaccines. "By giving its highest level of recommendation, the [ACIP] panel has placed strong pressure on state governments to make HPV vaccinations mandatory," she said. "If that happens, state officials, not parents, would be the primary sexual-health decision makers for America’s children. That’s the way things are done in dictatorships, not democracies."

Despite these objections, many healthcare professionals hail the vaccine as a major advance. It still remains to be seen whether the CDC will accept the ACIP’s recommendation, so that the government and medical insurance companies—and not individuals—would have to cover the cost of Gardasil. However, as Meredith Loveless, the head of the Johns Hopkins Pediatric and Adolescent Gynecology program, told New Scientist, "Generally this panel has quite a bit of influence. It definitely tips the odds in favor of insurance companies paying for the vaccine." Furthermore, should the CDC agree to the recommendation, the U.S. government could spend up to $2 billion vaccinating economically disadvantaged girls. Thanks to Gardasil, with the proper funding—and a comprehensive vaccination plan—the incidence of both HPV and cervical cancer could soon be dramatically reduced.
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Old 08-09-2006, 06:01 PM   #2
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Bibliography

"Advisers Back Cervical Cancer Vaccines." Associated Press, (June 29, 2006) [accessed July 19, 2006]: abclocal.go.com/ wls/ story? section= health& id= 4319104&ft= print.

"FDA Approves First Vaccine for Cervical Cancer." Associated Press, (June 16, 2006) [accessed July 19, 2006]: www.msnbc.msn.com/ id/ 13206572/ print/ 1/ displaymode/ 1098.

"FDA Licenses New Vaccine for Prevention of Cervical Cancer and Other Diseases in Females Caused by Human Papillomavirus." Press Release from the FDA, (June 8, 2006) [accessed July 19, 2006]: www.fda.gov/ bbs/ topics/ NEWS/ 2006/ NEW01385.html.

Harris, Gardiner. "Panel Unanimously Recommends Cervical Cancer Vaccine for Girls 11 and Up." New York Times, (June 30, 2006) [accessed July 19, 2006]: www.nytimes.com/ 2006/ 06/ 30/ health/ 30vaccine.html? ex= 1153281600& en= 5e6c7117f90c865f&ei= 5070.

Khamsi, Roxanne. "Cervical Cancer Vaccine Recommended for Pre-Teens." New Scientist (June 30, 2006) [accessed July 19, 2006]: www.newscientist.com/ article.ns? id=dn9448& print= true.

"Merck’s New Cervical Cancer Vaccine, Gardasil, Unanimously Recommended by CDC Advisory Panel for Vaccination of Girls and Women 11 to 26 Years." Press Release from Merck & Co, Inc., (June 29, 2006) [accessed July 19, 2006]: www.merck.com/ newsroom/ press_ releases/ product/ 2006_ 0629.html.
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