Gardasil® vaccine is Merck's first big drug development
since the Vioxx® disaster.
The basis for many Vioxx® lawsuits is that Merck
withheld information that clearly showed the dangers of the drug. The company's record does not inspire trust.
The Vioxx® situation revealed a more treacherous problem
existing within the FDA itself. FDA insiders exposed how the agency deliberately ignored abundant test information showing
that Vioxx® was dangerous to cardiac patients.
How does the HPV vaccine affect fertility? Birth defects? Risk
of cancers? Breast milk?
Five subjects who got the Merck vaccine around the time
of conception had babies with birth defects
HPV infection is often eliminated by the body's natural immune mechanisms. Abnormal
Pap tests often return to normal on their own. Cervical cancer is on the decline as are cervical cancer deaths, but it
still occurs in about 10,000 women a year with 3,700 dying. Pap tests are required whether or not you take the vaccine.
Condom use dramatically reduces chance of infection from all types of HP viruses,
by as much as 70%. There is no specific anti-viral treatment for infection, but the majority of infections are cleared
by the immune system anyway. Of women who contract HPV infection, 90% will clear the infection through the body's natural
immune processes. The younger the patient the more rapidly they naturally clear infection.
Does the vaccine work?
Who studied the vaccine in humans?
is a crucial part of full informed consent to let patients know that all human studies submitted to the FDA were done by or
financed by the drug manufactures. It cannot be brushed aside that these studies have limited
to no independent scientific review. In fact, it takes a formal Freedom Of Information Act request to obtain
the exact study reports and statistical analyses that the drug manufacturer gave to the FDA.
The studies that the drug maker gave to the FDA did not
tell if condom use was tracked; this is very important missing data, since condoms alone are responsible for a 70% reduction
in all types of HPV.
What is the effect of the vaccine on cervical cancer?
Since HPV is found in connection with most cervical cancers, the theory was that
a vaccine against HPV would prevent cervical cancer. However the vaccine studies couldn't demonstrate this, simply because
there were no cases of cervical cancer in the vaccinated group or in the group that got dummy shots.
So they used a substitute measure (a 'surrogate
marker') for cancer. They compared abnormal pre-cancerous Pap results in people who were vaccinated versus not vaccinated.
U.S. statistics show there are 30 to 40 cervical cancer cases per year per one
million women age 9-26, the ages the vaccine was tested on.
Gardasil®'s reduction of pre-cancers by 12.2% in the
general population would mean that instead of 30 to 40 cases of cancer, there would only be 26 - 35 cancers. So it would take
vaccination of a million girls to prevent cancer in 4 to 5 girls. About 37% die from cervical cancer, so that would prevent
1 to 2 deaths. So $360 million in vaccine would prevent 1 to 2 deaths.
However this is all conjecture. In the Merck studies the follow up was too short
and the numbers too few to prove prevention of cervical cancer.
Is the HPV vaccine safe?
Can the HPV vaccine actually make
The study showed an increase in pre-cancer related to the vaccine
types in the people who already had these infections before they got the vaccine.
They have invented a vaccine that kills humans and breaks
down the immune system.
A total of 102 subjects out of 21,464 total subjects (9- to 26-year-old girls and women and
9- to 15-year-old boys) who received both GARDASIL and placebo reported a serious adverse experience on Day 1-15 following
any vaccination visit during the clinical trials for GARDASIL.
The most frequently reportedserious adverse experiences
for GARDASIL compared to placebo and regardless of causality were: headache(0.03% GARDASIL vs. 0.02% Placebo),gastroenteritis(0.03%
GARDASIL vs. 0.01% Placebo),appendicitis (0.02% GARDASIL vs. 0.01% Placebo),pelvic inflammatory disease (0.02% GARDASIL vs.
0.01% Placebo).One case of bronchospasm and 2 cases of asthma were reported as serious adverse experiences that occurred during
Day 1-15 of any vaccination visit.
DeathsAcross the clinical studies, 17 deaths
were reported in 21,464 male and female subjects. The events reported were consistent with events expected
in healthy adolescent and adult populations. The mostcommon cause of death was motor vehicle accident (4 subjects who received
GARDASIL and 3 placebo subjects), followed by overdose/suicide (1 subject who received GARDASIL and 2 subjects who receivedplacebo),
and pulmonary embolus/deep vein thrombosis (1 subject who received GARDASIL and 1placebo subject). In addition, there were
2 cases of sepsis, 1 case of pancreatic cancer, and 1 case ofarrhythmia in the group that received GARDASIL, and 1 case of
asphyxia in the placebo group. Systemic Autoimmune Disorders In the clinical studies, subjects were evaluated for new medical
conditions that occurred over thecourse of up to 4 years of follow up. The number of subjects who received both GARDASIL
and placeboand developed a new medical condition potentially indicative of a systemic immune disorder
Gardasil: The Argument Against
There is a new vaccine recently approved for the "prevention of cervical cancer" called Gardasil. This vaccine
is administered as a three-dose series, costs about $120 per dose, and is being marketed for girls and women ages 9-26. So
what, if anything, is wrong with this picture?
Just this: The American Cancer Society estimates that in 2006 there will only be 9,710 new cases of cervical
cancer, and only 3,700 deaths. I am not disputing that these are horrible deaths, as are many other cancer deaths. But with
a total female population of just over 147,000,000, that translates to only about one in 2,500,000 women dying of cervical
cancer. At a cost of $360 dollars for the full 3-shot course of vaccine, that comes to about $900,000,000 to prevent one death.
One. I'm sorry; no matter how horrible a death, it's not worth 9/10ths of a billion dollars to prevent just one.
Merck (the vaccine's manufacturer) of course uses different numbers, coming up with a much greater benefit
by calcualting how many CIN2/3 (abnormal/precancerous paps) were prevented, according to the following statement in their
CIN 2/3 and AIS are the immediate and necessary precursors of squamous cell carcinoma and adenocarcinoma of
the cervix, respectively. Their detection and removal has been shown to prevent cancer; thus, they serve as surrogate markers
for prevention of cervical cancer.
Here's the fallacy: yes, every cervical cancer began with a CIN2 or 3, but not every CIN2/3 will go on to
an invasive cervical cancer. And of those, only about a third of those patients (in aggregate) will go on to die. But the
real catch-22 of the situation is that the women overwhelmingly more likely to die are those who never get a pap test.
Thus we have a huge paradox: those who come for cervical cancer screening, even relatively sporadically, are
not going to die of it. The vast majority of cervical cancer deaths are in women who have never had a pap. Not ever. Even
one lifetime pap reduces the already very small chance of dying of cervical cancer from tiny to ridiculously miniscule. Those
who die are those who do not get screened (for whatever reason, be it financial, cultural, socioeconomic, or other access
HPV Vaccine Mandates Risky and Expensive
Vaccine Safety Group Finds Serious Reactions, High Costs
Vienna, Virginia - /PRNewswire-USNewswire/
- The National Vaccine Information Center (NVIC), the nation's leading vaccine safety and informed consent advocacy organization,
is urging state legislatures to investigate the safety and cost of mandating Merck's HPV vaccine (GARDASIL) for all pre-adolescent
girls before introducing legislation amending state vaccine laws. In an analysis of reports made to the federal Vaccine Adverse
Event Reporting System (VAERS) since the CDC's July 2006 universal use recommendation for all young girls, NVIC found reports of loss of consciousness, seizures, joint pain and Guillain-Barre Syndrome. In
a separate evaluation of costs for young girls being vaccinated in private pediatrician offices, NVIC discovered that parents
living in the Washington, D.C. area will be paying between $500 and $900 to have their daughters receive three doses of GARDASIL.
safety appears to have been studied in fewer than 2,000 girls aged 9 to 15 years and it is unclear how long they were followed
up.  VAERS is now receiving reports of loss of consciousness, seizures, arthritis
and other neurological problems in young girls who have received the shot," said NVIC President Barbara Loe
Fisher. "At the same time, parents who take their daughters to private pediatricians are going to be shocked to find that
they will be paying two to three times the widely publicized $360 cost for the three-dose series. The cost is going to break
the pocketbooks of parents and break the banks of both insurance companies and taxpayers, when the reality is that almost
all cases of HPV-associated cervical cancer can be prevented with annual pap screening of girls who are sexually active."
July 2006 and January 2007, there have been 82 reports of adverse events filed with VAERS following receipt of GARDASIL by
girls and boys ranging in age from 11 to 27 years. Reaction reports have come from 21 states, including Virginia and the District
of Columbia. All but three of the reports were for adverse events which occurred within one week of vaccination and more than
60 percent occurred within 24 hours of vaccination.
"The most frequent serious health events after GARDASIL shots are neurological
symptoms," said NVIC Health Policy Analyst Vicky Debold, RN, Ph.D. "These young girls are experiencing severe headaches, dizziness,
temporary loss of vision, slurred speech, fainting, involuntary contraction of limbs (seizures), muscle weakness, tingling
and numbness in the hands and feet and joint pain. Some of the girls have lost consciousness during what appears to be seizures."
Debold added "The manufacturer product insert should include mention of syncopal episodes, seizures and Guillain-Barre Syndrome
so doctors and parents are aware these vaccine adverse responses have been associated with the vaccine."
also indicate the doctors are administering GARDASIL to girls and women at the same with Tdap, DT, meningococcal (Menactra),
hepatitis A, and other vaccines, even though the Merck product insert states that, with the exception of hepatitis B vaccine,
"Co-administration of GARDASIL with other vaccines has not been studied." There is no publicly available information about
how many of the 9 to 15 year old girls in Merck's pre-licensure clinical trials received GARDASIL simultaneously with hepatitis
Although approximately half of all families in the U.S. select a pediatrician in private practice to provide
their children routine care, including vaccinations, children can receive government subsidized reduced cost or free vaccinations
in public health clinics through the Vaccines for Children program if they cannot afford to pay for vaccinations administered
by private pediatricians. NVIC's survey of four private pediatric practices in the Virginia suburbs of Washington, D.C. found
that parents could be charged anywhere from $525 to $930 for three GARDASIL shots.
Is the vaccination worth the risks
That is currently another problem we are looking at/facing. They want to mandate this law to
enforce the vaccination.
This vaccination has not been on the market long enough to establish ALL the possible effects this vaccination
will or will not prove to show.
But as far as I am aware, one has not been on the market that has killed children until
But this one is coming straight out of market of only few years and have reported legitimate statitics
fact it IS killing children. Why should a vaccine be made a "LAW" to recieve? It
is our choice to give our children the vaccine.
Not the laws choice. They are working around a way for our opt out decision. Only making it religious
and physological, Please......