- The Washington Times - Tuesday, April 24, 2007

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

But despite growing concerns, states’ efforts to mandate Gardasil are moving much faster than with previous vaccines.

“The initial years that a vaccine is in use, before a mandate has been enacted, allow for the ‘system’ to be built and also allow for developing experience using the vaccine,” said Curtis Allen, a spokesman for the CDC.

“Based on what we know about the composition of the HPV vaccine, we have no reason to have specific concerns about the safety of the vaccine, but in the past, mandates have generally been enacted several years after a vaccine is introduced and recommended.”

Dr. Jon Abramson, chairman of the CDC’s Advisory Committee on Immunization Practices, which recommended that 11- and 12-year-olds get the vaccine, says that because HPV is not a contagious disease like measles, it might not be worth the cost to states to inoculate all students.

At about $360 for the three-shot regimen, Gardasil is the most expensive vaccine on the market. Most insurance plans will cover a percentage of its cost, and the federal Vaccines for Children Program is expected to cover about 45 percent of girls nationwide.

Although his panel chose to recommend inoculating preteen girls before they become sexually active, Dr. Abramson opposes Gardasil’s mandated use and says he advised Merck against lobbying state lawmakers to do so.

Public push

Merck’s lobbying efforts are widely credited with the speed at which a legislative initiative was begun in nearly 40 states. Working with Women in Government, an advocacy group for female state legislators, Merck prodded state lawmakers to prepare legislation while Food and Drug Administration approval was still pending. Many of the bills across the country have been introduced by members of Women in Government.

Merck called off its Gardasil lobbying effort in February after public criticism over the company’s motives began to swell. Merck had the backing of a number of prominent public-health organizations, including the American Cancer Society and the American Academy of Pediatrics, which have recommended that girls receive the vaccine.

The groups stopped short of pressing for the mandate that Merck wants. Some say they are not ready to endorse a mandate so soon after the vaccine gained FDA approval.

But Merck’s efforts, including TV and magazine advertising, has peaked the public’s interest about a virus that few had feared before.

Merck reported first-quarter Gardasil sales of $365 million, more than double the fourth-quarter sales of $155 million. Its sales will soar into the billions if millions of girls nationwide are forced to use the vaccine, analysts say.

In New Hampshire, where the state provides the HPV shots for free, demand is outstripping supply.

“We expected all along there would be an initial demand, but there is a finite amount of resources,” Greg Moore, spokesman for the state Department of Health and Human Services told the Associated Press. “This program is going to take a significant part of our budget over the next four years.”

One step forward

Yet for every state that is requiring Gardasil, another is backing away from mandating its use.

Last week in South Carolina, state lawmakers killed HPV vaccination legislation. The debate over the vaccine centered on conservative groups’ concerns that it could promote promiscuity. As conservative groups campaigned heavily against the bill, dozens of co-sponsors started removing their names.

“The virus is a sexually transmitted disease, and that would imply that 11-year-old girls are being promiscuous,” said Joe Mack, director of the South Carolina Baptist Convention. “That is one of the reasons we could never support this legislation.”

Meanwhile in California, lawmakers forced Mr. Hernandez to reverse course and revise the bill to overhaul the state’s childhood vaccination program.

“It seemed like a perfect storm came together for this bill to be very controversial,” Mr. Hernandez said.

Mr. Hernandez, who is convinced that Gardasil is an effective product, abandoned his attempt to require the vaccine, opting for legislation that calls for the state health department to wait five years before making a new vaccine mandatory. The bill was approved by the state legislature’s health committee last week.

After the waiting period, the state’s public health officer, an appointee of the governor, would decide whether to make the vaccine mandatory, make it optional or delay a decision for one year.

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