Aluminum is in HPV vaccine

[Guest guest]

http://www.findarticles.com/p/articles/mi_m0815/is_11_31/ai_n16838086

New cervical cancer vaccine should not be mandatory

<http://www.findarticles.com/p/articles/mi_m0815>Healthfacts,

<http://www.findarticles.com/p/articles/mi_m0815/is_11_31>Nov, 2006

The cervical cancer vaccine raises concerns that did not show up in

the news coverage about its approval last summer. Usually mass

vaccinations are advised for diseases with a high rate of death

and/or disability, but cervical cancer doesn't come close to meeting

that criteria. And most important: Is it safe to vaccinate all girls

for a disease that afflicts only 9,710 American women yearly and

causes 3,700 deaths? The answer might be yes, if the vaccine is

risk-free. But the nation's leading vaccine safety organization has

raised some serious reservations.

Those reservations were ignored last summer when the Centers for

Disease Control and Prevention Advisory Committee on Immunization

Practices voted to recommend that all 11- to 12-year-old girls

receive the human papillomavirus (HPV) vaccine called Gardasil. This

is a major step toward making the vaccine mandatory--at an age well

before girls are likely to become sexually active.

Only one company, Merck, makes the HPV vaccine, which is given in

three injections over six months and will cost $360. Merck says its

trials proved Gardasil is " 100% effective in preventing HPV infection

in those who do not already have HPV with strains 16 and 18, which

together cause about 70% of all cases of cervical cancer. "

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These Merck-sponsored trials were submitted to the FDA, and Gardasil

was approved. But Barbara Loe Fisher, an advocate for vaccine-safety

studies and the president of the National Vaccine Information Center,

questions the need for a cervical cancer vaccine given the

availability of the Pap test, which she believes has greatly reduced

the incidence of the disease. She also sees methodological flaws and

major deficiencies in what has been reported to the public about HPV

disease and the vaccine.

" Most people who have sex will have experience with HPV, but the

majority will clear it from the body and go on to have healthy lives.

Only a tiny percentage will have persistent HPV infection and will

experience changes over a long period of time that will lead to

cancer. On the list of cancers that kill, this is at the bottom, " she

said, referring to U.S. women, as opposed to those in developing

countries where cervical cancer deaths are far more common.

As a former member of the FDA Vaccines and Related Biologic Products

Advisory Committee, Fisher has considerable experience analyzing the

lengthy documents submitted by the vaccine companies to the FDA, as

well as the agency's own review of company-sponsored trials. Fisher's

safety concerns center on the type of placebo Merck used in the

Gardasil trials. " A true placebo would be a saline

solution--something that is innocuous and has no potential to cause a

reaction on its own, " she said, referring to the injection given

study participants who were assigned to the control group against

which Gardasil was compared.

Instead, Merck used a solution that contained aluminum, Fisher

explained, and neither the company nor the FDA has publicly disclosed

the amount used in the solution. " Aluminum is used as an adjuvant in

many vaccines to boost the potency of the vaccine, " she continued,

" and though it has been in vaccines for decades, it has never been

tested in clinical trials to see whether it is safe.

" We know from animal and human biological mechanism research that

aluminum can cause inflammation and brain cell death. Putting it in

the placebo [in a clinical trial] violates the principle of the

scientific method when trying to ascertain truth, " said Fisher. " To

make matters worse, aluminum is also in the Gardasil vaccine which

makes it difficult to tell whether the many adverse events reported

in the trials were due to the aluminum-containing placebo or the

Gardasil, " she explained, referring to the well-documented fact that

adverse events will show up in all clinical trial participants, even

those given an inactive placebo.

Why would the FDA overlook this potential for confounding trial

results? " The FDA has become partners with the vaccine manufacturers

in fasttracking these vaccines and in the process, the precautionary

principle has been thrown out, " Fisher responded, adding that most

health problems occurring in vaccine trials are often dismissed. " The

companies tend to write them off as unassociated with the vaccine.

Another disturbing aspect of the Gardasil approval process involves

the small number of young girls who actually participated in Merck's

trials. The company states that its trials had more than 20,000

participants, but it would take considerable time to pour through the

numerous pages of documentation in order to separate the adults from

the children. A New York Times reporter did just that last July. Roni

Rabin, who is also the mother of a nine-yearold girl, found that

fewer than 1,200 participants were under 16 and the younger girls

were followed for only 18 months.

This is not the first time that young children will be vaccinated for

a sexually transmitted disease. The first in a series of hepatitis B

vaccine shots is administered at birth. Few would object to hepatitis

B vaccinations for infants born of women infected with hepatitis B.

But there were plenty of objections, even among pediatricians, when

the hepatitis B vaccine became mandatory for a disease most likely to

afflict prostitutes, injection-drug users, and men who have sex with men.