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Article posted Feb 18 2007, 2:20 AM Category: Health Source: New York Times Print

Furor on Rush to Require Cervical Cancer Vaccine

STEPHANIE SAUL and ANDREW POLLACK

Racing to embrace a new vaccine, at least 20 states are considering mandatory inoculation of young girls against the sexually transmitted virus that causes cervical cancer.

But a roaring backlash has some health experts worried that the proponents, including the vaccine’s maker, Merck, have pushed too far too fast, potentially undermining eventual prospects for the broadest possible immunization.

Groups wary of drug industry motives find themselves on the same side of the anti-vaccination debate with unexpected political allies: religious and cultural conservatives who oppose mandatory use of the vaccine because they say it would encourage sexual activity by young girls.

Even some who support use of the vaccine question the rush and the vaccine’s high cost — about $400 for the three-shot course. “The decision to make this mandatory this early has created a significant controversy over things that have nothing to do with the vaccine,” said Dr. Joseph A. Bocchini, chairman of the committee on infectious diseases of the American Academy of Pediatrics.

Like most other public health experts, Dr. Bocchini advocates the vaccine’s use. But many say the rush toward mandatory inoculation could prove counterproductive.

Most of the proposals call for vaccinating girls before they enter the 6th grade, a group that would include about two million girls nationwide annually if all states imposed the requirement.

In Texas, Gov. Rick Perry recently issued an order that girls be vaccinated. But some legislators are trying to overturn the order, with some opponents complaining because the governor’s former chief of staff is now a lobbyist for Merck. State lawmakers are scheduled to hold a hearing Monday on a bill to rescind that order.

And in Illinois, a bill introduced by a legislator who had the virus the vaccine is intended to prevent prompted a conservative group’s blog to speculate that she had been promiscuous.

“I’m offended by their ignorance, but if I have to take a hit to educate people, I’m willing to do it,” said the bill’s sponsor, Debbie Halvorson, the Democratic majority leader in the Illinois Senate.

Ms. Halvorson is also a director of Women in Government, a national association of state legislators that has embraced the fight against cervical cancer and has received funding from Merck. The group has posted model mandatory vaccination legislation on its Web site, www.womeningovernment.org. The rush for mandatory inoculation — most of the state proposals have been introduced since the beginning of the year — is unusual. It was only last June that federal regulators approved the vaccine, called Gardasil.

Typically new vaccines, like the one for chicken pox in the mid-1990’s, have been rolled out gradually in this country, with public health officials endorsing mandatory use only after several years of experience have shown the new products to be generally safe and effective.

“Generally the mandates have been enacted over years,” said Dr. Janet R. Gilsdorf, the director of pediatric infectious diseases at the University of Michigan.

An advisory panel of the federal Centers for Disease Control and Prevention recommended last summer that girls and women ages 11 to 26 be vaccinated with Gardasil. But members of the committee say that such a recommendation is not equivalent to calling for mandatory vaccination.

Even before the vaccine’s approval, though, Merck had begun laying the political foundation in state legislatures to promote widespread vaccination of young girls.

Gardasil and another vaccine under development by the drug maker GlaxoSmithKline are aimed at the human papilloma virus, or H.P.V., which is known to be the cause of cervical cancer. Analysts see a potential $5 billion a year market for H.P.V. vaccines, and some say that Merck is intent on inoculating as many girls as possible before the introduction of Glaxo’s product, which could become available this year.

Merck’s president for vaccines, Margaret McGlynn, acknowledged a sense of urgency. But she said it was motivated by the need to eradicate the disease.

“Each and every day that a female delays getting the vaccine there is a chance she is exposed to human papilloma virus,” Ms. McGlynn said.

The company, which said it had shipped two million doses of Gardasil by the end of 2006, has begun advertising in many parts of the country. Merck declined to disclose its lobbying and advertising budget for the vaccine.

Gardasil protects against two strains of H.P.V. that cause about 70 percent of the cases of cervical cancer as well as two other strains that cause genital warts. In approving the vaccine last June, the Food and Drug Administration said that in the United States each year there were an average of 9,710 new cases of cervical cancer and 3,700 deaths attributed to it.

The disease’s toll is higher in other parts of the world than it is in the United States, where most women get routine Pap smears to detect early precancerous changes in the cervix. Worldwide, cervical cancer is the second-most-common cancer in women. It causes more than 470,000 new cases and 233,000 deaths each year, according to the F.D.A.

Merck’s main partner in the vaccination campaign, Women in Government, also receives funding from Glaxo, as well as Digene, a company that makes a test to detect the presence of H.P.V. Over the last two years, Women in Government has been holding a series of luncheons and conferences nationwide to discuss its fight against cervical cancer, including the use of vaccines.

Opponents of mandatory inoculation include anti-vaccine activists, who argue that the vaccine has not been tested in enough young girls and who have listed various side effects reported among users, which have included dizziness, nausea and fever. Others include conservative Christian groups who oppose mandatory H.P.V. vaccination on moral grounds, and those who are generally distrustful of the pharmaceutical industry.

“It’s a very messy thing to be promoting right now,” said Fran Eaton, editor of the conservative blog in Illinois where one writer attacked Senator Halvorson’s morality. “If you’re a conservative, you’re going to be worried about parental rights. If you’re a liberal, you’re worried that the pharmaceutical companies are taking over the United States.”

One activist who frequently criticizes pharmaceutical companies, Vera Hassner Sharav, and a co-author suggested that the H.P.V. vaccine stood for a campaign to “Help Pay for Vioxx” losses. Vioxx, the painkiller taken off the market in 2004 because it was linked to cardiovascular problems, was also made by Merck.

Lawmakers in Indiana have been targets of e-mail campaigns from out of state, according to Connie Lawson, a Republican Senator who sponsored the mandatory vaccine legislation pending in that state and who is the chairman of Women in Government.

“Accusations were being made,” Senator Lawson said. “I don’t even think I should repeat some of the things that were said.”

The controversy worries public health experts like Dr. Bocchini, who is also the chief of pediatric infectious diseases at the Louisiana State University Health Sciences Center. He is concerned that the outcry might make the public mistrustful of a vaccine that would otherwise be to its benefit.

“If the public had enough experience with the vaccine and had enough knowledge about H.P.V., the question about whether to get the vaccine or give it to their daughters wouldn’t be an issue,” Dr. Bocchini said.

Some of the bills, despite calling for compulsory vaccination, have “opt out” provisions, letting parents citing religious or moral grounds to choose not to have their daughters inoculated. Those provisions also have raised concerns among public health experts.

“A lot of us are concerned that if you allow people to opt out of one vaccine, they will opt out of other vaccines that are due at the same time,” said Dr. Mark Myers, executive director of the National Network for Immunization Information (www.immunizationinfo.org).

Several lawmakers have said that their motivation in supporting mandatory H.P.V. vaccines was to ensure widespread inoculation and to erase economic disparities in cervical cancer, which is most common among low-income women who are the least likely to have Pap smear screening.

The chairman of preventive medicine at Vanderbilt University, Dr. Willam Schaffner, said that when mandates were in place, racial and economic disparities in who was vaccinated virtually disappeared.

The first effort to mandate H.P.V. vaccinations for school girls began last fall in Michigan, where a bill, introduced by a leader in Women in Government, was defeated amid opposition from an anti-vaccine group.

But the main legislative thrust began this year in what appeared to be a coordinated effort. The National Conference of State Legislatures, which tracks such legislation, reports that at least 31 states are deliberating bills that would require vaccination, funding for vaccinations or the distribution of information about H.P.V. A synopsis of the bills is listed at the national conference’s Web site (www.ncsl.org/programs/health/HPVvaccine.htm).

Groups on both sides of the debate appear to have been energized by the executive order of Gov. Rick Perry on Feb. 2 mandating vaccination. Opponents have pounced on Gov. Perry’s ties to Merck and Women in Government. His former chief of staff is a lobbyist for Merck in the state and his wife, a nurse who has worked to promote health, once spoke at a Women in Government conference on cervical cancer.

“I looked at all of this and said, someone is playing politics,” said Cathie Adams, president of the Texas Eagle Forum, a branch of Phyllis Schlafly’s national Eagle Forum, a conservative group that calls itself “pro-family.”

Citing various reasons, the Texas Medical Association is not currently supporting mandatory vaccination.

Dr. Carol Baker, a professor of pediatrics at Baylor College of Medicine in Houston, said that two other vaccines for adolescents that were approved in recent years — against meningitis and whooping cough — have not yet been mandated in Texas. “To mandate just one, in my view, is a little odd,” she said.

The American Academy of Pediatrics is not advocating mandatory Gardasil vaccination, either. One source of opposition from pediatricians is cost. Buying enough H.P.V. vaccine for 100 girls would require a practice to lay out nearly $40,000 in advance. Many doctors say that the insurance reimbursement for giving the vaccine is not adequate to compensate them for administering it.

Dr. Bocchini of the American Academy of Pediatrics also said too much of the Gardasil focus was being placed on 11- and 12-year-olds, when legislatures should be focusing on trying to obtain funding to vaccinate girls and women in the 13-to-26 age group, many of whom are not covered by the federal vaccine programs aimed at children.

“A number of people are just not going to be able to get this vaccine,” he said.





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