NVIC Calls Merck & FDA “Not Completely Honest” Re: Pre-adolescent HPV Vaccine Safety

The disasters are due to the agency’s approval of unsafe drugs–such as Merck’s
anti-inflammatory drug, Vioxx.

The FDA hastily approved Merck’s HPV vaccine which is designed to prevent
cervical cancer and genital warts in sexually active women.  However, the
vaccine has not been proven safe and effective in clinical trials.  The
trials are being criticized for using a placebo containing aluminum adjuvant
(whose adverse reaction profile makes the vaccine appear safer than it is),
rather than using a non-reactive saline solution polacebo.

Here’s how: the vaccine triggered adverse event reports in 90% of the test
subjects within 15 days–hardly an indication of safety.  However, the
controversial placebo formula triggered 85% adverse event reports.  How does
the FDA know what long-term adverse effects the vaccine might produce?  Have
we learned nothing from the disastrous DES effects on the daughters of women
who took the hormone during pregnancy triggering cancer and genital
deformaties. See: http://www.cancer.gov/cancertopics/factsheet/Risk/DES

The HPV vaccine is being promoted for use in girls 9-15 years of age.  

National Vaccine Information Center  president, Barbara Loe Fisher,  says
"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."

When the science becomes politicized–whether from the conservative right or
from the liberal left–don’t trust ANYTHING that’s being said.
Absent scientific evidence demonstrating the safety of the HPV vaccine,
there is no guarantee that this will not prove to be a disaster for the next
Contact: Vera Hassner Sharav
veracare@ahrp.org <mailto:veracare@ahrp.org>  

Press Release
    Source: National Vaccine Information Center    

Merck’s Gardasil Vaccine Not Proven Safe for Little Girls
Tuesday June 27, 1:07 pm ET
National Vaccine Information Center Criticizes FDA for Fast Tracking

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

"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.


(scroll down to Vaccines and Related Biologicals

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

Source: National Vaccine Information Center