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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.
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