NVIC: MERCK'S GARDASIL VACCINE NOT PROVEN SAFE FOR LITTLE GIRLS

Ilena Rosenthal & The Humantics Foundation applaud the work of NVIC
and prays for their safety as they uncover the facts around Gardasil.

http://ilena-rosenthal.blogspot.com
http://ilena-rosenthal.blogspot.com/...cer-while.html

We believe we are up against perhaps the biggest media campaign ever
staged by the pharmaceutical industry.

Merck and the many frontgroups are working on every level to sell as
much of this product as fast as possible, and millions are being spent
on lobbying governments, countries, school systems, using every medium
.... including Usenet.


www.BreastImplantAwareness.org/
http://ilena-rosenthal.blogspot.com
http://ilenarose.blogspot.com
Health Lover


http://www.909shot.com/PressReleases...06gardasil.htm

MERCK'S GARDASIL VACCINE NOT PROVEN SAFE FOR LITTLE GIRLS
National Vaccine Information Center Criticizes

EXCERPT: "Merck and the FDA have not been completely honest with the
people about the pre-licensure clinical trials," said NVIC president
Barbara Loe Fisher. "Merck's pre and post-licensure marketing strategy
has positioned mass use of this vaccine by pre-teens as a morality
play in order to avoid talking about the flawed science they used to
get it licensed. This is not just about teenagers having sex, it is
also about whether Gardasil has been proven safe and effective for
little girls."

The FDA allowed Merck to use a potentially reactive aluminum
containing placebo as a control for most trial participants, rather
than a non-reactive saline solution placebo.[1] A reactive placebo can
artificially increase the appearance of safety of an experimental drug
or vaccine in a clinical trial. Gardasil contains 225 mcg of aluminum
and, although aluminum adjuvants have been used in vaccines for
decades, they were never tested for safety in clinical trials. Merck
and the FDA did not disclose how much aluminum was in the placebo.[2]

Animal and human studies have shown that aluminum can cause nerve cell
death [3] and that vaccine aluminum adjuvants can allow aluminum to
enter the brain, [4 5] as well as cause inflammation at the injection
site leading to chronic joint and muscle pain and fatigue. [6 7]
Nearly 90 percent of Gardasil recipients and 85 percent of aluminum
placebo recipients followed-up for safety reported one or more adverse
events within 15 days of vaccination, particularly at the injection
site.[8] Pain and swelling at injection site occurred in approximately
83 percent of Gardasil and 73 percent of aluminum placebo recipients.
About 60 percent of those who got Gardasil or the aluminum placebo had
systemic adverse events including headache, fever, nausea, dizziness,
vomiting, diarrhea, myalgia. [9 10] Gardasil recipients had more
serious adverse events such as headache, gastroenteritis,
appendicitis, pelvic inflammatory disease, asthma, bronchospasm and
arthritis.

"Merck and the FDA do not reveal in public documents exactly how many
9 to 15 year old girls were in the clinical trials, how many of them
received hepatitis B vaccine and Gardasil simultaneously, and how many
of them had serious adverse events after being injected with Gardasil
or the aluminum placebo. For example, if there were less than 1,000
little girls actually injected with three doses of Gardasil, it is
important to know how many had serious adverse events and how long
they were followed for chronic health problems, such as juvenile
arthritis."

According to the Merck product manufacturer insert, there was 1 case
of juvenile arthritis, 2 cases of rheumatoid arthritis, 5 cases of
arthritis, and 1 case of reactive arthritis out of 11,813 Gardasil
recipients plus 1 case of lupus and 2 cases of arthritis out of 9,701
participants primarily receiving an aluminum containing placebo.
Clinical trial investigators dismissed most of the 102 Gardasil and
placebo associated serious adverse events, including 17 deaths, that
occurred in the clinical trials as unrelated.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
http://www.909shot.com/PressReleases...06gardasil.htm


MERCK'S GARDASIL VACCINE NOT PROVEN SAFE FOR LITTLE GIRLS
National Vaccine Information Center Criticizes
FDA for Fast Tracking Licensure

Washington, D.C. - The National Vaccine Information Center (NVIC) is
calling on the CDC's Advisory Committee on Immunization Practices
(ACIP) to just say "no" on June 29 to recommending "universal use" of
Merck's Gardasil vaccine in all pre-adolescent girls. NVIC maintains
that Merck's clinical trials did not prove the human papillomavirus
(HPV) vaccine designed to prevent cervical cancer and genital warts is
safe to give to young girls.

"Merck and the FDA have not been completely honest with the people
about the pre-licensure clinical trials," said NVIC president Barbara
Loe Fisher. "Merck's pre and post-licensure marketing strategy has
positioned mass use of this vaccine by pre-teens as a morality play in
order to avoid talking about the flawed science they used to get it
licensed. This is not just about teenagers having sex, it is also
about whether Gardasil has been proven safe and effective for little
girls."

The FDA allowed Merck to use a potentially reactive aluminum
containing placebo as a control for most trial participants, rather
than a non-reactive saline solution placebo.[1] A reactive placebo can
artificially increase the appearance of safety of an experimental drug
or vaccine in a clinical trial. Gardasil contains 225 mcg of aluminum
and, although aluminum adjuvants have been used in vaccines for
decades, they were never tested for safety in clinical trials. Merck
and the FDA did not disclose how much aluminum was in the placebo.[2]

Animal and human studies have shown that aluminum can cause nerve cell
death [3] and that vaccine aluminum adjuvants can allow aluminum to
enter the brain, [4 5] as well as cause inflammation at the injection
site leading to chronic joint and muscle pain and fatigue. [6 7]
Nearly 90 percent of Gardasil recipients and 85 percent of aluminum
placebo recipients followed-up for safety reported one or more adverse
events within 15 days of vaccination, particularly at the injection
site.[8] Pain and swelling at injection site occurred in approximately
83 percent of Gardasil and 73 percent of aluminum placebo recipients.
About 60 percent of those who got Gardasil or the aluminum placebo had
systemic adverse events including headache, fever, nausea, dizziness,
vomiting, diarrhea, myalgia. [9 10] Gardasil recipients had more
serious adverse events such as headache, gastroenteritis,
appendicitis, pelvic inflammatory disease, asthma, bronchospasm and
arthritis.

"Merck and the FDA do not reveal in public documents exactly how many
9 to 15 year old girls were in the clinical trials, how many of them
received hepatitis B vaccine and Gardasil simultaneously, and how many
of them had serious adverse events after being injected with Gardasil
or the aluminum placebo. For example, if there were less than 1,000
little girls actually injected with three doses of Gardasil, it is
important to know how many had serious adverse events and how long
they were followed for chronic health problems, such as juvenile
arthritis."

According to the Merck product manufacturer insert, there was 1 case
of juvenile arthritis, 2 cases of rheumatoid arthritis, 5 cases of
arthritis, and 1 case of reactive arthritis out of 11,813 Gardasil
recipients plus 1 case of lupus and 2 cases of arthritis out of 9,701
participants primarily receiving an aluminum containing placebo.
Clinical trial investigators dismissed most of the 102 Gardasil and
placebo associated serious adverse events, including 17 deaths, that
occurred in the clinical trials as unrelated.

"There is too little long term safety and efficacy data, especially in
young girls, and too little labeling information on contraindications
for the CDC to recommend Gardasil for universal use, which is a signal
for states to mandate it," said Fisher. "Nobody at Merck, the CDC or
FDA know if the injection of Gardasil into all pre-teen girls -
especially simultaneously with hepatitis B vaccine - will make some of
them more likely to develop arthritis or other inflammatory autoimmune
and brain disorders as teenagers and adults. With cervical cancer
causing about one percent of all cancer deaths in American women due
to routine pap screening, it was inappropriate for the FDA to fast
track Gardasil. It is way too early to direct all young girls to get
three doses of a vaccine that has not been proven safe or effective in
their age group."

The National Vaccine Information Center (NVIC), founded in 1982 by
parents of vaccine injured children, has been a leading critic of
one-size-fits-all mass vaccination policies and the lack of basic
science research into biological mechanisms and high risk factors for
vaccine-induced brain and immune system dysfunction. As a member of
the FDA Vaccines and Related Biological Products Advisory Committee
(VRBPAC), Barbara Loe Fisher urged trials include adequate safety data
on pre-adolescent children and warned against fast tracking Gardasil
at the November 28-29, 2001 VRBPAC meeting .[11]

Full 2001 FDA Transcript:
http://www.fda.gov/ohrms/dockets/ac/cber01.htm#Vaccines & Related
Biological

For more information go to www.NVIC.org.

-end-

1. Merck & Co., Inc. 2006. Gardasil [Quadrivalent Human Papillomavirus
Types 6,11,16,18) Recombinant Vaccine] product insert. Table 6.

2. Food and Drug Administration. May 18, 2006. FDA Background Document
for Vaccines and Related Biological Products Advisory Committee:
Gardasil HPV Quadrivalent Vaccine.

3. Kawahara M et al. 2001. Effects of aluminum on the neurotoxicty of
primary cultured neurons and on the aggregation of betamyloid protein.
Brain Res. Bull. 55, 211-217.

4. Redhead K. et al. 1992. Aluminum-adjuvanted vaccines transiently
increase aluminum levels in murine brain tissue. Pharmacol. Toxico.
70, 278-280.

5. Sahin G. et al. 1994. Determination of aluminum levels in the
kidney, liver and brain of mice treated with aluminum hydroxide. Biol.
Trace. Elem. Res. 1194 Apr-May;41 (1-2):129-35.

6. Gherardi M et al. 2001. Macrophagaic myofastitis lesions assess
long-term persistence of vaccine-derived aluminum hydroxide in muscle.
Brain, Vol 124, No. 9, 1821-1831.

7. Shingde M eta la. 2005. Macrophagic myofastitis associated with
vaccine derived aluminum. MJA, 183 (03):145-146.

8. Merck & Co. May 18, 2006. Merck briefing document for Vaccines and
Related Biological Products Advisory Committee: Gardasil. Table 24.

9. Merck & Co., Inc. 2006. Gardasil product insert: Serious Adverse
Experiences.

10. Food and Drug Administration. May 18, 2006. FDA Background
Document for Vaccines and Related Biological Products Advisory
Committee.: Gardasil. Table 32.

11. Food and Drug Administration. November 29, 2001. Vaccines and
Related Biological Products Advisory Committee. Excerpt from
transcript.