August 1, 2006
Re: Gardasil Vaccine
Friends,
Business as usual in the vaccine
world.
See especially the fourth paragraph,
beginning: "The FDA allowed Merck " . . .
Basically what Merck did was to
put poisonous aluminum in the placebo . . . so that their new
"Gardasil" vaccine wouldn't compare unfavorably in their experiment
on young girls.
This deceptive practice is in no way
news. It is business as usual for the pharmaceutical companies and their
business partner, the FDA.
This kind of deception is not
significantly different from the over 200 years of fraud foisted on an
unwitting public since Jenner purchased (not earned) his medical degree at the
end of the 18th century.
Disease exists. Vaccines are not now,
and have never been, the answer.
Jock
http://www.nvic.org/PressReleases/pr62706gardasil.htm
For immediate release
June 27, 2006
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.
-----
Jock Doubleday
Director
Natural Woman, Natural Man, Inc.
A California 501(c)3 Nonprofit
Corporation
http://www.SpontaneousCreation.org
http://www.SpontaneousCreation.org/SC/links.htm
director@spontaneouscreation.org