vaccine not safe for little girls

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Merck's Gardasil Vaccine Not Proven Safe for Little Girls

National Vaccine Information Center Criticizes FDA for Fast Tracking

Licensure

WASHINGTON, June 27 /PRNewswire/ -- 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 & RelatedBiologi

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al

(scroll down to Vaccines and Related Biologicals

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