Furor on Rush to Require Cervical Cancer Vaccine_NYT

The New York Times reports that “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.”

The Alliance for Human Research Protection is proud to have played a role in
helping to open a public debate about Merck’s flagrant commercial push to
influence public officials into mandating its human papilloma virus (HPV)
vaccine, Gardasil, for girls aged 11 to 26.

The duration of the vaccine’s efficacy is uncertain, its limited testing in
only several hundred pre-adolescent girls provides inadequate safety data
about its potential long-term hazards. Given that condoms are entirely
safe–for both males and females–and they are no less effective not only
for the papilloma virus, but for ALL sexually transmitted diseases, and
given that PAP tests will continue to be a necessary safety precaution, what
is the justification for a government mandated vaccination of girls?

The debate has generated public mistrust because the Emperor has been shown
to be naked–there are no compelling medical-scientific justifications for
mandatory HPV vaccination:

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.

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

Even the vaccine’s advocate,  Dr. Joseph A. Bocchini, chairman of the
committee on infectious diseases of the American Academy of Pediatrics,
acknowledges  “The decision to make this mandatory this early has created a
significant controversy…”

Of note: 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.

“One activist who frequently criticizes pharmaceutical companies, Vera
Hassner Sharav, 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.

NBC’s Today show (February 15) held an debate between two pro-mandatory
vaccination–NBC’s “resident doctor” Nancy Snyderman, M.D. joined by  Texas
legislator, Jessica Farrar, who introduced a bill in Texas to require sixth
grade girls to get HPV vaccine–against Barbara Loe Fisher, President of
Vaccine Information Center.   The debate was a follow-up to a debate ( Feb.
5) between Farrar and Dawn Richardson, president of Parents Requesting Open
Vaccine Information, which generated a huge number of emails and letters to
NBC.

For this second round of the debate, NBC featured the network’s chief
medical editor, Dr. Snyderman, who used her “authority” to dominate and to
tilt the debate toward the pro-mandatory vaccine camp.  (stay tuned on
biased medical news reporting in the media)
See the video of the debate on NBC Today and judge for yourself:
http://tinyurl.com/preview.php?num=2kfkb4

Underscoring the reality about the unknown risks that FDA approved drugs and
vaccines pose, on Feb. 15, the FDA issued an advisory to parents to be on
the lookout for their babies bowels collapsing after getting injected with
the newly approved diarrhea vaccine, Rotateq. The FDA asks doctors and
parents to report cases of bowel blockage (intussusception) that babies
suffer after getting Rotateq to the federal Vaccine Adverse Event Reporting
System (VAERS).

Shouldn’t the FDA also ask doctors and parents to report all serious health
problems after little girls get injected with Merck’s newly approved HPV
Vaccine, GARDASIL ?

Contact: Vera Hassner Sharav
212-595-8974
veracare@ahrp.org

http://www.nytimes.com/2007/02/17/health/17vaccine.html
THE NEW YORK TIMES
Furor on Rush to Require Cervical Cancer Vaccine
February 17, 2007
By 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,  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.

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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