Barbara Loe Fisher Commentary:
There is a
an old saying in politics: Don't count your chickens before they are hatched.
Texas Governor Rick Perry should have remembered that old saying before crowning
himself King and wielding his executive branch power like a scepter over the
Texas legislature in order to force all little girls in Texas to get three doses
of Merck's HPV vaccine, GARDASIL.
The funny thing about it is that Merck
had launched a massive PR/advertising blitz for GARDASIL on TV and in magazines
and, with a little help from some friends, was successfully simultaneously
introducing bills in multiple states with a military precision not seen since
the invasion of Iraq. It was breathtaking in scope and public health officials,
many doctors, politicians and editors were giving GARDASIL a standing ovation as
the greatest advancement in the history of vaccines and cancer prevention. Flush
with the victory of having convinced the FDA that GARDASIL should be fast-
tracked into early licensure in the summer of 2006 and with unanimous blessing
by the CDC's Advisory Committee on Immunization Practices (ACIP) that GARDASIL
should be used by all pre-adolescent girls, Merck was on a roll.
Merck
was on a roll until parents, who were being threatened with state mandates
forcing their little girls to get three doses of GARDASIL, started to object
after taking a closer look at the evidence for the safety, efficacy and costs of
GARDSIL to prevent 3700 cases of cervical cancer every year that can be
prevented with routine pap screening and early treatment of pre-cancerous signs.
Some legislators and investigative reporters started asking questions. It was
revealed that Merck was, in effect, funding the political effort to get many
states to mandate the vaccine. The National Vaccine Information Center issued a
press release on Feb. 1 questioning how Merck could possibly know whether it was
safe to give GARDASIL to little girls when they only studied less than 2,000 of
them in pre-licensure clinical trials and when reports were already coming into
VAERS that indicated some pretty serious health events were occurring after
GARDASIL vaccination. Some legislators in some states pulled state mandate
proposals or modified them to include opt-in provisions for parents.
Then Merck choked, convincing the Governor of Texas to put on his cowboy
hat and perform the Heimlich maneuver. But what they didn't count on was public
opinion when it comes to messing around with the democratic process and
freedom.
After PROVE's Dawn Richardson stood her ground against HPV
vaccine mandates in Texas on NBC's "Today Show"and legislators and doctors alike
told "King Perry" on Tuesday that he had gone too far, today an MSNBC poll of
more than 85,000 responders shows that the majority of Americans do not think
HPV vaccine mandates are right.
Actually, the Governor of Texas and Merck
may have done America a favor: the debate about the threat to freedom and the
democratic process posed by forced vaccination policies, the influence of
corporations in the political process, and abuse of power by the chiefs of
executive branches of government is now being openly discussed.
Let
freedom ring.
Vaccine Center Issues Warning
The
Washington Times
February 3, 2007
by Gregory Lopes
Click
here for the URL:
The National
Vaccine Information Center yesterday warned state officials to investigate the
safety of a breakthrough cancer vaccine as Texas became the first state to make
the vaccine mandatory for school- age girls.
Negative side effects of
Gardasil, a new Merck vaccine to prevent the sexually transmitted virus that
causes cervical cancer, are being reported in the District of Columbia and 20
states, including Virginia. The reactions range from loss of consciousness to
seizures.
"Young girls are experiencing severe headaches, dizziness,
temporary loss of vision and some girls have lost consciousness during what
appear to be seizures," said Vicky Debold, health policy analyst for the
National Vaccine Information Center, a nonprofit watchdog organization that was
created in the early 1980s to prevent vaccine injuries.
Following
federal approval of the vaccine in July 2006, a storm of legislation was
introduced across the nation that would make the vaccine mandatory in schools.
The District and Virginia are part of a group of at least 17 states considering
such legislation. A measure had been introduced in Maryland, but it was shelved
last week over concerns about the mandatory language in the bill.
Yesterday, Texas Gov. Rick Perry signed an order making Texas the first
state to require the vaccine. Girls ages 11 and 12 would receive the human
papillomavirus (HPV) vaccine before entering the sixth grade starting in
September 2008.
The American Cancer Society estimates there were 9,710
new cases of cervical cancer in the United States in 2006. The District's cancer
control center estimates a total of cervical cancer cases in the city last year,
and the American Cancer Society estimates that last year Maryland and Virginia
each had 210 cases of cervical center.
Merck began marketing Gardasil
last year after the Food and Drug Administration approved it for females ages 9
to 26. The vaccine is the first of its kind to build immunity against two
strains of HPV, which lead to 70 percent of cervical cancer cases in the United
States.
The vaccine is not effective in men, who can get cancer from
other strains of HPV.
Its side effects were reported to the Vaccine
Adverse Event Reporting System, a federal reporting system for consumers to
notify federal regulators of bad reactions to medications. The adverse events
began being reported in July 2006, when an advisory panel to the Centers for
Disease Control and Prevention recommended girls ages 11 and 12 receive the
series of shots.
The types of side effects reported are not cause for
alarm, according to the American Cancer Society.
"We have not been
informed of an instance that would call into question the overall safety of the
vaccine," said Debbie Saslow, director of breast and cervical cancer control at
the American Cancer Society, adding that about 70 similar events had been known
in October 2006.
Likewise, the CDC will not alter its approval of the
vaccine despite the number of adverse events revealed through the reporting
system.
"A report to the Vaccine Adverse Event Reporting System does not
necessarily mean the adverse event was serious or that it was caused by the
vaccine," said CDC spokesman Curtis Allen. "This vaccine has been tested around
the world and has been found to be safe and effective."
Merck is heavily
promoting the vaccine through its salespeople imploring doctors to provide it
and running TV ads urging young women to get vaccinated so there will be "One
Less" cancer patient.
But physicians disagree with public health
officials over whether Gardasil is the panacea for cancer. Clayton Young, an
obstetrician/gynecologist in Texas, objects to Merck's claim that Gardasil will
prevent cervical cancer.
"There is no proof Gardasil will stop cervical
cancer," he said. "They haven't been studying it long enough to make that
claim."
Merck spokesman Chris Loder said the vaccine is effective for
five years and the Whitehouse Station, N.J., drug maker is not sure how long
afterward the vaccine will work. Critics point out that an additional booster
shot may be necessary.
Advocates for a mandatory vaccine say that
although the vaccine does not prevent all causes of cervical cancer, Gardasil is
an effective vaccine against the most prevalent cause and therefore is a correct
public health measure.
Gardasil is delivered in three separate
injections that cost $120 to $150 per injection. Blue Cross Blue Shield, an
omnipresent health insurer in the Mid-Atlantic region, covers the vaccine for
girls in the federally recommended age groups.
Merck revenue from
Gardasil reached $155 million for the fourth quarter of 2006 and $255 million
for the entire year.
POINTS OF
CONTENTION
Concerns over mandating shots:
• Some parents say a
vaccine for HPV, the sexually transmitted disease that can cause cervical
cancer, effectively condones premarital sex.
• Long-term efficacy and
risk of side effects are unclear. There have been 82 reports of adverse events
associated with the vaccine.
• Gardasil is typically covered by
insurance, but is costlier than many other common
vaccines.

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