Furor on Rush to
Require Cervical Cancer Vaccine
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Mike Derer/Associated Press
Nicole Giacopelli, 17, left, receives a shot of
Gardasil, a new cervical cancer vaccine, from Dr. Jill Stoller in
Woodcliff Lake, N.J. |
By STEPHANIE SAUL and
ANDREW POLLACK, NYTimes February 17, 2007
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.
Ralph Blumenthal contributed reporting from Houston.
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