Subject: Examining the FDA's records on Gardasil - Not ready for
the public, (2) Death Toll Rises (3) Deaths and Adverse Reactions
Update (4) Merck Slips as FDA Rejects Wider Gardasil Use, Forbes
(5) Is Vaccine Responsible for Teen Paralysis?
More evidence the Merck HPV vaccine is not ready for the public and
no state funds should be used to provide access for this vaccine.
Link to the 25-page report:
http://www.judicialwatch.org/documents/2008/JWReportFDAhpvVaccine
Records.pdf
If it has been deleted you may visit any number of archive sites that store vital information such as this.
KP Stoller, MD
President, International Hyperbaric Medical Assoc
Medical Director, Hyperbaric Medical Center of New Mexico (and New
Mexico Aspartame Detox Center)
www.hbotnm.com
Death toll linked to Gardasil vaccine rises
Complications include shock, 'foaming at mouth,' convulsions, coma
"Anaphylactic shock," "foaming at mouth," "grand mal convulsion,"
"coma" and "now paralyzed" are a few of the startling descriptions
included in a new federal report describing the complications from
Merck & Co.'s Gardasil medication for sexually transmitted human
papillomavirus which has been proposed as mandatory for all schoolgirls.
The document was obtained from the U.S. Food and Drug Administration
by Judicial Watch, a Washington group that investigates and
prosecutes government corruption, and it has details of 10 deaths
just since September.
"Given all the questions about Gardasil, the best public health
policy would be to re-evaluate its safety and to prohibit its
distribution to minors. In the least, governments should rethink any
efforts to mandate or promote this vaccine for children, said
Judicial Watch President Tom Fitton.
The organization's work uncovered reports of about one death each
month since last fall, bringing the total death toll from the drug
to at least 18 and as many as 20. There also were 140 "serious"
reports of complications including about three dozen classified as
life-threatening, 10 spontaneous abortions and half a dozen cases of
Guillain-Barre Syndrome.
The document reveals the case of an 18-year-old woman who got the
Gardasil vaccine, was found unconscious that evening, and died.
Another woman, age 19, got the drug and the next morning was found
dead in her bed.
The new documents also reveal a total of 8,864 Vaccine Adverse Event
Reporting System records, up from a total of 3,461 that had been
reported in a document just last fall.
WND previously has reported how Merck was lobbying state lawmakers
to require the vaccination, but said it would quit the campaign
after its activities were unveiled.
WND also reported when a key researcher into human papillomavirus,
which is targeted by Gardasil, reported it needed more testing, and
how even the Centers for Disease Control suggested the vaccine
should not be mandatory.
That, however, has not diverted the building campaign to have
legislatures adopt mandatory vaccination plans.
Judicial Watch said one of the reports, VAERS ID: 310262-1 (D), had
this to say:
"Information has been receivedconcerning a 20-year-old female with
no medical history reported, who on 01-APR-2008 was vaccinated with
a dose of Gardasil.The patient died four days afterpatient sought
unspecified medical attention. An autopsy was performed which ruled
out suicide and anything suspicious."
Another report said, "Information has been received from a physician
concerning a female patient who on an unknown date was vaccinated
with a dose of Gardasil. Subsequently, the patient experienced a
coma and is now paralyzed. At the time of this report, the patient's
outcome was unknown. VAERS ID: 303188-1"
The target of the vaccine is cervical cancer, since studies show
that those who have HPV have a higher chance of later developing
cervical cancer. However, opponents note that such cancers develop
most often in older women, while the plan is to require girls as
young as 11 or 12 years old to be inoculated. They cite the lack of
evidence that the vaccine would have an impact later in life.
A Judicial Watch report said, "Even though Gardasil will not be
fully tested for safety until 2009, physicians are already pushing
it as a routine, harmless vaccine. Merck's aggressive advertisement
campaign tells young girls that their lives could be 'one less'
affected by cervical cancer and that, 'It's your turn to help guard
against cervical cancer.'"
The report also estimated it will cost as much as $2 billion to buy
vaccinations for the nation's poorest girls.
"This vaccine will be more expensive than all other childhood
vaccines put together," concluded John Schiller, a National Cancer
Institute investigator.
Judicial Watch earlier uncovered reports such as this:
"Initial and follow-up information has been received from a
physician concerning an 'otherwise healthy' 13 year old female who
was vaccinated with her first and second doses of Gardasil.
Subsequently, the patient experienced paralysis from the chest down,
lesions of the optic nerveAt the time of the report, the patient had
not recovered."
Officials with the Abstinence Clearinghouse noted in a position
paper that groups including the Texas Medical Association, the
American Academy of Pediatrics, the Association of American
Physicians and Surgeons, and the American Academy of Environmental
Medicine have come out publicly against mandatory vaccination.
"The reasoning of these medical associations is clear. They are not
opposed to medical progress, and certainly support all efforts to
combat life-threatening diseases. The problem, as these
organizations see it, lies in the fact that the drug only went
through three and a half years of testing, leaving the medical
community somewhat in the dark as to what serious adverse effects
might result in the long term," the group said at the time.
"Along with the potential of serious adverse effects is the question
of efficacy. There is evidence that after approximately four years,
the vaccine's potency significantly declines. The long-term value of
the vaccine has yet to be determined; if it wears off within six
years, will girls and women need to repeat the battery of injections
they originally received?" the organization wondered.
Michigan was the first state to introduce a plan to require the
vaccine to be given to young girls, but the proposal failed. Ohio
also considered a failed plan in 2006.
In 2007 Merck's aggressive lobbying campaign and contributions to
Women in Govern
_______________________________________________
Gardasil Vaccine - Deaths And Adverse Reactions Update
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Promoting Openness, Full Disclosure, and Accountability
Judicial Watch Gardasil Vaccine Safety Update: 18 Deaths
FYI
***Though approved for marketing by the FDA in May 2006, Merck's HPV
vaccine, Gardasil, is still in the testing stages, and will not be
fully evaluated for safety until September 2009***
Gardasil gained FDA approval under a fast track process--within 6
months of testing. Fast-track approval is a process reserved for
life-saving products with the potential to fill an unmet medical
need, such as, new cancer treatments or AIDS drugs.
A special report issued by Judicial Watch, "Examining the FDA's HPV
Vaccine Records: Detailing the Approval Process, Side-Effects, Safety
Concerns and Marketing Practices of a Large-Scale Public Health
Experiment" is (June 30, 2008) shows that aggressive lobbying by
Merck--rather than medical need backed by scientific data--led the
FDA to approve Gardasil before adequate testing for safety had
been completed.
The report is a MUST READ for every parent considering vaccinating a
daughter with Merck's papillomavirus (HPV) vaccine, Gardasil. The
report should be required reading for every public health official
and policy maker. See
>
the FDA's HPV Vaccine Records
Thousands of documents were obtained by Judicial Watch after filing a
lawsuit against the FDA. The documents include Merck's patent and
drug information submitted to the FDA, transcripts and briefing
material from approval meetings, and reports documenting health,
safety, and efficacy test results, as well as Vaccine Adverse Event
Reporting System (VAERS) documents.
VAERS reports provide details about 8,864 cases of adverse effects
experienced by girls and women after receiving the Gardasil vaccine.
Since January 2008, the FDA identified 140 as "serious" reports (27
were categorized as "life threatening"), 10 spontaneous abortions and
6 cases of Guillain-Barre Syndrome. VAERS reports show that at least
eighteen people have died after receiving Gardasil. See
submitted to VAERS.
Adverse report excerpts include:
* Information has been received...concerning a 20 year old female
with no medical history reported, who on 01-APR-2008 was vaccinated
with a dose of Gardasil....The patient died four days after...patient
sought unspecified medical attention. An autopsy was performed which
ruled out suicide and anything suspicious. The cause of death is
currently unknown. VAERS ID:310262-1 (D)
* Information has been received.concerning a 23-year-old female.who
on 31-JAN-2008 was vaccinated with her 1st dose of Gardasil...the
patient experienced anaphylactic shock 2 minutes after vaccination
characterized by a brief loss of consciousness...respiratory arrest,
eyes rolled upwards, blurred vision and greyish skin tone ...
Anaphylactic shock was considered to be immediately life-threatening.
VAERS ID: 304739-1 (S)
* Cold sweat, Fall, Foaming at mouth, Grand mal convulsion, Immediate
post-injection reaction....Pt [patient, 14-year-old female] received
vaccine, took 6 steps, fell to the ground unconscious and had a 60
sec grand mal seizure then regained consciousness. [Blood pressure]
after seizure 60/40 pale clammy skin. [Patient] had bit her tongue
and had foam around her mouth. VAERS ID: 305259-1 (S)
* Information has been received from a physician concerning a female
patient who on an unknown date was vaccinated with a dose of
Gardasil. Subsequently, the patient experienced a coma and is now
paralyzed. At the time of this report, the patient's outcome was
unknown. VAERS ID: 303188-1
Most health officials believe that adverse reactions to medications
are vastly underreported, as they are optional. Safety experts
estimate that only between 1% and 10% of adverse effects are
reported. Therefore the actual number of adverse events occurring
after vaccination with Gardasil is likely to be much higher.
Based on the reports submitted to the VAERS database, Gardasil is
demonstrably a risk-laden vaccine.
Even without Gardasil, cervical cancer deaths have decreased
drastically in the past several decades. The American Cancer Society
estimates that deaths from cervical cancer declined 74% between 1955
and 1992, and that the rate continues to decrease by about 4% each year.
Since condoms are indisputably a safe, non-invasive, cost-effect
method for protecting boys and girls / men and women against ALL
sexually transmitted diseases -- Why are we exposing American girls
and young women to a public health experiment whose benefits are
unclear while its risks include death ?
Below is the Executive Summary of Judicial Watch's special report.
Contact: Vera Hassner Sharav
212-595-8974
Judicial Watch Special Report:
Examining The FDA's HPV Vaccine Records
In May 2007, Judicial Watch submitted a request to the FDA under the
Freedom of Information Act for all records concerning Merck's new
anti-HPV vaccine, Gardasil.
After Judicial Watch filed a lawsuit in October 2007 to compel record
production, the FDA finally released four sets of documents, the last
in June 2008. These records detail the development and expedited
approval of Gardasil. The documents include patent and licensing
memoranda, test reports for the vaccine, and the final briefing
document on Gardasil submitted to the FDA in April 2006, one month
before the vaccine was approved. The FDA also produced 8,864 VAERS
reports. Judicial Watch uncovered a transcript of Merck's May 18,
2006, meeting with the Vaccines and Related Biological Products
Advisory Committee (VRBPAC), at which the vaccine received a
unanimous vote of approval.
Analysis of the records shows:
* Gardasil is a prophylactic, preventative vaccine and will not treat
pre-existing HPV infection. It is not a cancer vaccine or cure.
* Gardasil is marketed as a vaccine that prevents cancer, but it " .
. . has not been evaluated for the potential to cause carcinogenicity
or genotoxicity."
* Gardasil is not 100% effective against all HPVs. It is designed to
protect against only four strains of HPV, even though there are over
thirty strains including at least fifteen that can cause cancer.
* While Gardasil is the most expensive vaccine ever to be recommended
by the FDA, its long-term effectiveness is unknown and could be as
brief as only two to three years.
* During testing, an aluminum-containing placebo was used. Aluminum
can cause permanent cell damage and is a reactive placebo, unlike
most standard saline placebos. This means that tests of Gardasil may
not have given an accurate picture of safety levels.
* Although some states are considering making it mandatory for young
girls to get the Gardasil vaccine, it has only been tested with one
other vaccine commonly given to children. There are ten commonly
administered adolescent vaccines.
* Gardasil is still in the testing stages, and will not be fully
evaluated for safety until September 2009. VAERS reports show that as
many as eighteen people have died after receiving Gardasil.
See
>
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