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A rush to vaccinate

Protecting girls from cervical cancer is a worthy goal. But a new vaccine may not be as effective as promised.

May 29, 2007

WHEN LOBBYISTS for major drug companies embark on major pushes with politicians, the results are seldom laudable. Though there is reason to hope that a new Merck vaccine, Gardasil, will significantly reduce the incidence of cervical cancer, lawmakers nationwide moved with unseemly haste to require inoculations for all young girls. Their rush seems especially precipitous in light of a new study that has raised questions about how effective the vaccine ultimately will prove.

In drug trials, Gardasil has been shown to be safe and effective at halting the two strains of human papilloma virus that most commonly cause cervical cancer. Key to the vaccine's effectiveness is administering it before a woman is exposed to the virus, which is spread through sexual intercourse. This explains the valid interest in providing the vaccine to prepubescent girls despite the cost of more than $300 per vaccination.

It has mostly been religious conservatives who have railed against requiring Gardasil vaccinations for girls entering middle school. There's little merit to their argument that mandating the vaccine is an unconscionable intrusion on parental mores. HPV is a communicable disease with often fatal consequences. It should be stamped out if possible.

But just because critics of the vaccine argued their case on the wrong grounds does not mean they were wrong. Now, after all the early hoopla, it has become less clear that Gardasil will succeed in nearly eliminating HPV. A recent study in the New England Journal of Medicine indicated that blocking the two primary HPV strains might create an opportunity for other strains to flourish, so that the overall reduction in cancers would be relatively small. In addition, safety in the general population over time often differs from experimental safety -- as the Merck painkiller Vioxx tragically illustrated.

Public health officials have not yet grappled with complex issues surrounding Gardasil. If the vaccine prevents only a couple of virus strains, how best to make patients aware that they lack full protection? Given the high cost, is the public getting the best preventive-medicine bang for its buck? Is it right to use schools to force the issue when, unlike polio, the disease cannot be caught through casual contact?

Flush with initial promises about the drug's potential, legislators in at least 24 states, from Virginia to California, introduced proposals to mandate Gardasil inoculations for middle schoolers. Those bills swept aside legitimate concerns, at least until reports revealed that Merck had launched an aggressive lobbying campaign to push mandatory vaccination.

Since then, would-be mandates have withered across the country. In California, a bill by Assemblyman Ed Hernandez (D-West Covina) to require the vaccine has been softened to near irrelevance, giving state officials the power to require it in four years if they find it has been safe and effective. The state doesn't need this. If Gardasil proves itself over time, Hernandez can introduce a bill with real teeth later.

Gardasil still makes sense as an option for many girls and young women. But the rush to force a new vaccine on families has served mainly as a reminder to beware of even well-intentioned lawmakers bearing drug-company gifts.

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