HPV vaccine concerns give legislatures pause

The initial rush to require the inoculation of preteen girls with the new HPV vaccine Gardasil fueled by Merck & Co.’s lobbying is meeting resistance as state lawmakers nationwide begin to question its safety, long-term effectiveness and cost.

California legislators backed off mandating the vaccine for seventh-grade girls last week and will consider becoming the first state to require a five-year waiting period before adding it to the list of vaccines required for school enrollment.

New Mexico Gov. Bill Richardson vetoed legislation to compel its use by sixth-grade girls earlier this month, saying there is insufficient time to educate parents, schools and health care providers about the vaccine that could help prevent cervical cancer.

“It is far too early for this vaccine to be mandatory. We don’t know about its long-term effectiveness or safety,” said Lawrence Gostin, director of the Center for Law and the Public’s Health at Johns Hopkins and Georgetown Universities.

“A response to the rush to mandate could backfire on us with public dissatisfaction and serve as a deterrent to all vaccinations.”

Maryland legislation was pulled earlier this year because of cost concerns. But Virginia this month became the second state, after Texas, to make the vaccine mandatory for girls, and D.C. lawmakers passed their own version last week. Both versions have parental opt-out provisions.

Time and money

Questions about Gardasil, which guards against the two strains of the sexually transmitted human papillomavirus (HPV) that cause 70 percent of cervical cancer cases, have begun to emerge since more than 23 state legislatures quickly moved to require its use by schoolgirls within months of its June approval by the federal government.

“There were a lot of valid concerns like the efficacy time frame and side effects. We began to wonder if it is proper for elected officials to decide if each and every vaccine is safe,” said California Assemblyman Ed Hernandez, a Democrat who sponsored both of his state’s measures.

Infectious-disease specialists and cancer pathologists, including members of the Centers for Disease Control and Prevention panel whose support of the drug was interpreted by states as a call to act, say that Gardasil should not be mandatory and that its five-year window of effectiveness raises concerns about whether the right age group is being targeted.

Cancer data show that the average cervical-cancer patient is 47 and most likely contracted HPV, which incubates for up to 15 years before becoming cancer, in her 30s more than a decade after the Gardasil’s proven effectiveness if given to 11- to 13-year-old girls as a requirement for school attendance.

Jennifer Allen, spokeswoman for Merck, said it is not possible to predict beyond five years whether the vaccine will require a booster shot, adding that the company continues to monitor female clinical trial participants.

Cervical cancer annually strikes more than 10,000 of the nation’s 108 million women, killing about 3,700.

Medical experts also question Gardasil’s required use because of the limited amount of data on its effect on teenage girls, including potential side effects, and its $360 price tag. Gardasil is the only anti-HPV vaccine on the market, which makes HPV-inoculation requirements a boon for Merck.

Rush to require

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