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HPV

Published On July 23, 2007

POLICY

Should the HPV vaccine become mandatory for girls?

Point: Yes, it will help prevent diseases; Counterpoint: No, it was inadequately tested.

POINT: The HPV vaccine will help prevent diseases, which is far preferable to treating them, says Marilyn Tavenner, Virginia’s secretary of health and human resources, a registered nurse and former national president of outpatient services for the Hospital Corporation of America.

Earlier this year Virginia’s legislature became the first in the nation to require sixth-grade girls to be vaccinated against HPV, a virus that can lead to cervical cancer and whose deadliest strains are transmitted sexually. Although inoculation will cost approximately $360 per child for a series of three injections over a six-month period, Virginia will likely save health care dollars in the long run: By inoculating preadolescents, thousands will be spared from surgery, hospitalization or premature death. The Centers for Disease Control and Prevention (CDC) estimates that the cost per quality-adjusted life year saved by vaccinating against high-risk HPV types 16 and 18 is as much as $25,000, which compares favorably with other preventive interventions. (The cost saved by screening for hypertension in 40-year-old men, for example, is at least $28,000.)

HPV infection is a major cause of cervical cancer. An estimated 11,150 cases of invasive cervical cancer will be diagnosed in the United States in 2007, of which about 3,670 will eventually be fatal, according to the American Cancer Society. The CDC also estimates that 6.2 million Americans are infected annually with HPV via sexual transmission.

Merck’s vaccine, Gardasil, helps protect against the two HPV strains—16 and 18—that are responsible for 70% of cervical cancers. Gardasil is also effective against HPV types 6 and 11, which do not lead to cancer but cause roughly 90% of cases of genital warts. In a recent study (published in the Journal of the American Medical Association [JAMA], Feb. 28) of females ages 14 to 59, 73.2% had no detectable HPV infection, 23.4% had a strain not covered by Gardasil and 3.4% carried the four strains it does cover. Both Merck and GlaxoSmithKline (which produces Cervarix, currently under FDA review) are working on improving their vaccines to cover more types of HPV.

Studies on Gardasil’s safety are reassuring. The vaccine contains no potentially infectious live virus. Although safety-study participants in the youngest category (ages nine to 15) numbered only approximately 1,100, the vaccine was extremely effective in that age group: More than 99% developed antibodies after vaccination. And the four studies analyzed by the FDA prior to approval included 21,000 women ages 16 to 26. Even more safety data will be available by the time routine inoculation begins in the fall of 2009.

To address the concerns of parents who believe the decision to immunize should rest with them rather than the state, Virginia offers a good middle ground: It allows a voluntary opt-out and it provides that parents receive materials describing the link between HPV and cervical cancer.

There is no cure for HPV, only treatments for diseases the virus causes. Mandating the vaccine means it will reach sufficient numbers of young women to make a difference in curbing a cancer that claims too many lives.

 

COUNTERPOINT: The vaccine was inadequately tested on nine- to 15-year-olds, and its effectiveness doesn’t justify its relatively high cost,says Benjamin Brewer, a family practitioner in rural Forrest, Ill., who writes an online column every other Tuesday for the Wall Street Journal.

During a 10-year-old girl’s recent office visit, her mother voiced misgivings about the HPV vaccine. She was aware of the limited safety testing conducted among preteens and couldn’t reconcile the risk against the uncertain benefit. Too many medicines have been recalled in recent years, she reasoned, and she would rather wait and see how the HPV vaccine performs over time.

Considering that the vaccine was tested on only about 1,100 girls, her point was well taken. The data is simply too sparse to gain a good grasp of the vaccine’s safety.

To be truly effective and clinically useful, the HPV vaccine also needs broader coverage against more viral strains. Scientists have identified about 30 types of genital HPV, 15 of them high-risk types that can lead to cervical cancer. Gardasil’s coverage of just two of the 15 makes for a tattered safety net.

The vaccine’s relatively steep cost—$360 for three injections—demands a higher level of value. If you spent $360 on every preteen girl in the United States, you could purchase a lot of primary care and prevention that would do more for their long-term health than an HPV vaccine.

Look at the patients who get cervical cancer. They’re often poor women without regular access to primary care, so they aren’t getting annual Pap smears. A better use of resources would be to target the highest-risk group and make sure they’re being screened for cervical cancer.

Reports on the prevalence of HPV vary, but CDC investigators have found that types 16 and 18 were identified in only a small percentage of the JAMA study’s participants. A mass vaccination program for such a small group doesn’t make economic sense, especially considering the enormous health needs facing our society. Illinois, my home state, is facing a $2 billion budget deficit. Yet a bill introduced in February calls for vaccinating all 11- and 12-year-old girls in the state, at a cost of about $4 million to cover the estimated 18,000 uninsured girls in that age group. The question becomes whether we should add millions more in deficit spending for a vaccine with limited results.

A lot of needs are being ignored because the HPV issue is one that grabs headlines and scores political points. It’s an easy talking point to say that you voted for an advance that prevents cancer, while conveniently forgetting the price tag.

I’ll concede that the economic equation could change. In clinical trials, Cervarix blocks two additional HPV types—45 and 31, the third and fourth most prevalent cancer-causing strains. And time will tell us more about the vaccine’s safety.

For now, I’m inclined to side with my 10-year-old patient’s mother. Wait and see is wise advice.

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