[PROVE] FW: [NVIC] NVIC SAYS GARDASIL NOT PROVEN SAFE

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E-NEWS FROM THE NATIONAL VACCINE INFORMATION CENTER

Vienna, Virginia http://www.nvic.org

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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. 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.

Animal and human studies have shown that aluminum adjuvants can cause

brain cell death and that vaccine aluminum adjuvants can allow aluminum to

enter the brain, as well as cause inflammation at the injection site leading

to chronic joint and muscle pain and fatigue. Nearly 90 percent of all Gardasil

recipients and 85 percent of aluminum placebo recipients reported one or more

adverse events within 15 days of vaccination, particularly at the injection

site. Pain and swelling at injection site and fever 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. 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 fewer 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 in 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

http://www.fda.gov/ohrms/dockets/ac/cber01.htm#

Vaccines & Related Biological

For references and more information, go to www.nvic.org.

-end-

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News@... is a free service of the National Vaccine Information Center and

is supported through membership donations. Learn more about vaccines, diseases

and how to protect your informed consent rights http://www.nvic.org

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