Merck and FDA conspire to defraud the public with HPV vaccine

[Guest guest]

FYI

The FDA appears to have learned nothing from recent catastrophic disasters

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

generation.

Contact: Vera Hassner Sharav

veracare@...

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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

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 & RelatedBiological

(scroll down to Vaccines and Related Biologicals

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

<http://www.nvic.org/> .

Regards,