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Proposed HPV Vaccine Mandates Draws Fire
From the National Vaccine Information Center
"Even ignoring the limited incidence of cervical cancer, we are troubled by
the newness of the vaccine, the small sample of preteen girls studied and
the disturbingly short guarantee of immunity. The vaccine has been on the
market for only eight months, not nearly enough time to discover the range
of adverse effects before administering it to tens of thousands of girls in
a statewide mandate. More than 25,000 patients were part of a clinical trial
of Gardasil, but only 1,184 of them were preteen girls. “That’s a thin base
of testing upon which to make a vaccine mandatory,” Barbara Loe Fisher, co-
founder of the National Vaccine Information Center, said in a Feb. 7 Wall
Street Journal article. The center lobbies for safer vaccines." - Editorial,
Rockford Register Star, Illinois
"We're really not lining one company's pockets with this," said Dr. Colleen
Kraft, president of the Virginia chapter of the American Academy of
Pediatrics, which supports the mandate....."We should proceed down this road
very carefully," said Del. Robert Marshall, R-Prince William. "The company
that is producing this is the same company that produced Vioxx." - Kimball
Payne, Hampton Roads Daily Press
"Even some watchdog groups like the Center for Public Policy Priorities
believe Perry's move is unconstitutional. "What can't happen is for the
governor to just wake up one morning and say, 'we're going to have a new law
in the state of Texas. I just wrote it. You have to have a whole rule-making
proceeding where the public gets notice, the public gets an opportunity to
come and comment, the executive commissioner has to consider their comments,
and then develop a rule based on those comments," CPPP Executive Director
Scott McCown said. Twenty-six senators from both parties even signed a
letter asking Perry to withdraw the order. Now it's up to the governor to
decide if the controversy will continue." - News 8, Austin, Texas
It’s premature to mandate cancer vaccine
Editorial
Rockford Register Star, IL
Published: February 12, 2007
http://www.rrstar.com/apps/pbcs.dll/article?AID=/20070212/OPINION03/102120005
One argument against mandating a cervical cancer vaccine for preteen girls
revolves around morality: Will the vaccine encourage girls to have sex?
That isn’t our concern. We don’t believe the vaccine should be mandatory for
a host of reasons having nothing to do with whether the vaccine would
condone early sex and spawn a generation of promiscuous 11- and
12-year-olds. That’s a bogus issue.
Set aside cervical cancer and there are still plenty of frightening things
for girls about having sex — getting AIDS, getting pregnant, getting a
sexually transmitted disease.
Illinois Senate President Emil Jones has introduced a bill that would
mandate all 11- and 12- year-old girls to receive a vaccination against the
human papillomavirus (HPV) that causes cervical cancer. Beginning Aug. 1,
2009, girls would not be allowed to enter any grade of a public, private, or
parochial school unless they present to the school proof of having received
the vaccine. There is an opt- out clause if parents object.
Jones is not a pioneer in the mandate effort; already, some 20 states are
considering or have passed similar measures. We believe they are being
hasty, and they may be feeling the pressure of intense lobbying by Merck,
the manufacturer of Gardasil, the only vaccine available on the market.
We encourage them to slow down and look at the facts. Courage to face down
misguided moralists to protect women’s health is one thing; ignoring
troubling medical questions is another.
Texas Gov. Rick Perry, who signed an executive order Feb. 2 mandating the
vaccine, wrote on the editorial page of USA TODAY: “Some are focused on the
cause of this cancer, but I remain focused on the cure. And if I err, I will
always err on the side of protecting life ...
“If we could stop lung cancer, would some shy away claiming it might
encourage tobacco use? This is a rare opportunity to act, and as a pro-life
governor, I will always take the side of protecting life.”
But how many lives? How much protection? And at what cost?
According to the Centers for Disease Control and Prevention, 12,085 women in
the United States were diagnosed with cervical cancer in 2002. The same
year, 3,952 women died of the disease. The incidence of cervical cancer has
gone down dramatically in the last four decades because of widespread use of
the Pap test to detect problems.
In contrast, one of the most common cancers to attack women — breast cancer
— claims 41,619 women’s lives a year and is responsible for 181,646 annual
diagnoses.
Even ignoring the limited incidence of cervical cancer, we are troubled by
the newness of the vaccine, the small sample of preteen girls studied and
the disturbingly short guarantee of immunity.
The vaccine has been on the market for only eight months, not nearly enough
time to discover the range of adverse effects before administering it to
tens of thousands of girls in a statewide mandate.
More than 25,000 patients were part of a clinical trial of Gardasil, but
only 1,184 of them were preteen girls. “That’s a thin base of testing upon
which to make a vaccine mandatory,” Barbara Loe Fisher, co- founder of the
National Vaccine Information Center, said in a Feb. 7 Wall Street Journal
article. The center lobbies for safer vaccines.
The vaccine guarantees immunity, but only for five years and only against
HPV strains that cause 70 percent of cervical cancer cases. Worst-case
scenario, a child vaccinated at 12 might lose her immunity at just the time
she needs it: at 17, when the chances of her having sex increase.
All of these questions should be considered against the backdrop of Merck’s
financial position. The Wall Street Journal says mandatory vaccination would
be an “automatic blockbuster” for the pharmaceutical company, at a time when
its patents on other bestselling drugs are expiring.
The vaccine might very well be the right choice for many girls, an
appropriate balance of risk and benefit. That only can be determined after
consultation with your doctor and in the context of your family.
Vaccine maker fills war chests
Campaign coffers get a boost from Merck, whose anti- cancer shot is being
weighed by legislators as a requirement for girls
Hampton Roads Daily Press
February 11, 2007
BY KIMBALL PAYNE
http://www.dailypress.com/news/local/dp-52313sy0feb11,0,4664322.story?coll=dp-news-local-final
RICHMOND -- Virginia is poised to require schoolgirls be given a
controversial new cancer-blocking vaccination produced solely by a drug
company generous with campaign cash for key state lawmakers.
Merck & Co. has given nearly $197,000 in contributions to dozens of Virginia
politicians and campaign committees since 1997 and is touting the vaccine in
a national push.
Among those who've received Merck money over the past decade are two of the
General Assembly's biggest proponents of the vaccines this session.
The pharmaceutical giant has given $10,000 to Del. Phil Hamilton, R-Newport
News, and $4,100 to Sen. Janet Howell, D-Fairfax, according to the Virginia
Public Access Project, a nonprofit campaign finance watchdog.
Hamilton and Howell pushed vaccination mandates through the state Senate and
House of Delegates. Final approval on the legislation is expected in the
next few weeks. The bills would require shots for all girls entering sixth
grade in the 2009 school year. Hamilton said that what's at issue is
fighting cancer, not political fundraising.
"It's not about the manufacturer," said Hamilton, who chairs the House
Health, Welfare and Institutions Committee. "It's about one thing and one
thing only - anti-cancer. When you're leading the pack, people are going to
criticize you."
Howell could not be reached for comment.
In June, the Food and Drug Administration signed off on the vaccine called
Gardasil that blocks strains of the human papillomavirus, a sexually
transmitted disease which infects 80 percent of women by the time they turn
50 years old, according to the Centers for Disease Control and Prevention.
Several strains of the virus can lead to cervical cancer, which kills about
3,700 women a year in the United States.
Texas became the first state to require schoolgirls get the vaccine.
Republican Gov. Rick Perry bypassed the legislature and signed an executive
order Feb. 2 requiring shots for sixth-grade girls in September 2008.
More than a dozen states are considering adding the vaccine to the list of
required immunizations already given to schoolgirls.
A competing pharmaceutical company - GlaxoSmithKline Inc. - is pushing for
federal approval for a nearly identical vaccine.
Either set of shots would fulfill the proposed requirement in Virginia.
"We're really not lining one company's pockets with this," said Dr. Colleen
Kraft, president of the Virginia chapter of the American Academy of
Pediatrics, which supports the mandate.
During a recent debate, one staunch House conservative openly questioned
Merck's track record.
"We should proceed down this road very carefully," said Del. Robert
Marshall, R-Prince William. "The company that is producing this is the same
company that produced Vioxx."
Merck had to pull Vioxx - a profitable painkiller and anti-inflammatory -
from the market in 2004, after further research found it increased the risk
of heart attacks and strokes.
That's why vaccine side effects are tracked in a national database, Kraft
said, noting that in 1999 the side effects directory identified problems
with a vaccine against rotavirus that was immediately pulled from the
market.
Hamilton's bill would give schools 30 months to prepare for the program and
allow health care professionals to further track research about the
injections.
The series of shots would cost roughly $360.
"It's not like were rushing into something that's going to be mandated
tomorrow," Hamilton said.
Parents can seek medical or religious exemptions from the vaccinations.
The House version allows parents who review information about the virus to
decline injections. The Senate passed the vaccine mandate without the
additional exemption, so the two chambers will have to negotiate a
compromise.
Expanding the list of required injections and broadening exemptions could
erode parents' confidence in all vaccines, said Dr. Louis Cooper of the
National Network of Immunization Information, which does not weigh in on
policy debates.
"Mandating a vaccine is a big step," Cooper said. "It runs the risk of
pouring gasoline on the whole mandate issue."
Reduced confidence in vaccinations, he said, could undermine the required
vaccines that stamp out contagious diseases such as measles and mumps that
"could spread through a school like wildfire."
Controversy heats up over HPV executive order
News 8 Austin, TX
February 8, 2007
By Bob Robuck
http://www.news8austin.com/content/headlines/?ArID=178886&SecID=2
The heat is almost to the boiling point over Gov. Rick Perry's executive
order regarding the HPV vaccine. Perry bypassed the legislative process and
ordered a law that mandates mandatory vaccination against HPV for girls
entering the sixth grade.
"Although I support the governor in the action he's trying to propose, it
has created such a firestorm because the legislators think they're being cut
out of the process," bill author Sen. Leticia Van de Putte said.
Sen. Jane Nelson, chair of the Health and Human Services Commission, is the
one carrying most of the burden since she will have to carry out the
governor's order. Nelson has asked for help from the state attorney
general's office. It won't offer an opinion for 180 days.
Even some watchdog groups like the Center for Public Policy Priorities
believe Perry's move is unconstitutional.
"What can't happen is for the governor to just wake up one morning and say,
'we're going to have a new law in the state of Texas. I just wrote it. You
have to have a whole rule-making proceeding where the public gets notice,
the public gets an opportunity to come and comment, the executive
commissioner has to consider their comments, and then develop a rule based
on those comments," CPPP Executive Director Scott McCown said.
Twenty-six senators from both parties even signed a letter asking Perry to
withdraw the order. Now it's up to the governor to decide if the controversy
will continue.
"I would prefer, for the good of the safety of the process and also so that
we can get this really good public policy, that the legislature should
decide this and not by executive order," Van de Putte said.
Perry is also being criticized because the vaccine's manufacturer
contributed to his re-election campaign.
Even if the governor doesn't withdraw the order on his own, some watchdog
groups believe he'll have to do it at some point. They feel the attorney
general's office will side with pulling the measure. Either that, or it
could wind up in the courts.
From the National Vaccine Information Center
email: news@nvic.org
voice: 703-938-dpt3
web:
http://www.nvic.org
NVIC E-News is a free service of the National Vaccine Information Center and
is supported through membership donations.
NVIC is funded through the financial support of its members and does not
receive any government subsidies. Barbara Loe Fisher, President and Co-
founder.
Learn more about vaccines, diseases and how to protect your informed consent
rights at www.nvic.org
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