Saturday, August 30, 2008

Health

USN Current Issue

Don't Rush to Judgment

By Bernadine Healy M.D.
Posted 2/18/07

A Texas-size ruckus has erupted in Austin over Gov. Rick Perry's recent executive order to mandate the new vaccine against the sexually transmitted human papillomavirus for preteen girls entering middle school. This has prompted antivaccine rallies, opposition from the Texas Medical Association, and debate on the cost of the vaccine (up to $450)-not to mention what seems like a heavy-handed invasion of parental rights. Legislators are trying to rescind the order and are holding hearings this week. Many states are considering HPV proposals, and some that were looking to make the vaccine compulsory seem to be backing away in the face of the firestorm in the Lone Star State.

Let's give the governor his due. This is a breakthrough vaccine that prevents infection by two of the most common HPV strains, 16 and 18, which underlie 70 percent of cervical cancers. (There are other cancer-inducing strains not covered by the vaccine, so inoculation doesn't replace the need for regular Pap smears.) The vaccine also targets strains 6 and 11, which cause 90 percent of condylomata acuminata, otherwise known as anogenital warts. Ideally, the vaccine should be given before the first sexual encounter. And since 7.4 percent of adolescents become sexually active before they turn 13, the federal Advisory Committee on Immunization Practices recommended the vaccine for preteen girls. But remember, this was a committee recommendation, not a mandate.

James Colgrove, a professor at Columbia University's Mailman School of Public Health, predicted back in December that moves to require HPV vaccinations would ignite polarizing debates. Writing in the New England Journal of Medicine, he pointed out that bioethicists tend to be skeptical about compulsory vaccination laws, particularly when a disease is not casually transmissible. HPV isn't like chickenpox or polio, where ordinary contact can result in exposure. It's also a mistake to conclude that women will die without urgent public action. Great Britain, for example, is intentionally going slow in adopting this new vaccine, concerned that a hasty introduction could undermine a successful system of cervical cancer screening.

Another element that gives some doctors pause is that the vaccine is still quite new. We have no proof that the vaccine will reduce cancer of the cervix, only that it reduces abnormal cells that show up on Pap smears-which in most young women clear up on their own. Doctors have also questioned the wisdom of mass inoculations of 11- or 12-year-olds when protection beyond five years is unknown. Furthermore, the vaccine was approved on an expedited track, and limited patient experience and long-term follow-up prevent doctors from fully addressing safety issues. Altogether, this makes mandatory HPV vaccines, at the least, premature.

Carrier concern. This controversy does, however, expose the delicate matter of gender. HPV is not only a girls' problem, and public-health efforts to knock out an infectious disease don't usually ignore the carriers. But boys are more than carriers. Genital warts are a common sign of HPV infection in men, and HPV-rarely but surely-can lead to carcinoma of the penis. There is also evidence that as many as 20 percent of head and neck cancers, particularly cancer of the mouth and tonsil, are linked to HPV 16. These cancers affect men three times as often as women and have known risk factors that include oral sex and a history of genital warts. Unfortunately, we are woefully ignorant about HPV in men, largely because of a lack of the tools-like Pap smears-that have taught us about the virus in women.

So, for now, be practical. It will be women, not the boys or the preteens, who will determine the fate of this promising vaccine. Let's persuade the ones who will most immediately benefit-young, sexually active women-to get the vaccine. And they should benefit, as research shows that most women between 16 and 26 have not yet been infected with the HPV strains the vaccine protects against. Their experience will offer more safety data and tell us whether the early and easily curable cancers of the cervix, detected and treated by the thousands every year in screening programs, start to plummet. Women skittish about the vaccine can wait at little risk to their health, as long as they, too, continue gynecologic screening. If the vaccine proves as beneficial as expected, not only will men want in, but the public will also have what it needs to determine whether a mandate is in order.

This story appears in the February 26, 2007 print edition of U.S. News & World Report.

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