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Anthrax Vaccine - Postal Workers warnedSubject: Anthrax Vaccine - Postal Workers warned
Date: Sat, 5 Jan 2002 19:56:07 -0800
Reprinted from NewsMax.com
Postal Workers Warned Against Pentagon Anthrax Vaccine
New York City postal union officials Thursday advised mail workers against taking the Department of Defense's vaccine for anthrax offered by Thompson, rather insisting the city's main processing center be fumigated against the deadly anthrax spores. Workers have already been on a regime of the Cipro antibiotic and have no symptoms.
Thompson had offered the postal workers post-exposure doses of the controversial DoD anthrax vaccine as an extra measure of caution. Each member was given an informed-consent form to read and execute before acceding to the vaccinations.
'Take Advantage of the Opportunity'
In the Thompson letter, Smith said he was "particularly disturbed by the statement made by a participant at the December 15, 2001 anthrax vaccine meeting at the CDC that 'it's also our duty to take advantage of the opportunity' [with the postal workers] to study the anthrax vaccine.'"
Noting that the DoD vaccine has never been scientifically shown to be effective as a post-exposure remedy, Smith asked Thompson: "Is this an experimental post-exposure use of the vaccine, or is it pre-exposure prophylaxis for postal workers who must continue to work in contaminated buildings? The United States Postal Service's inability to thoroughly clean the Morgan facility raises serious questions about residual anthrax contamination in Morgan and other postal facilities."
The CDC, which falls under Thompson's department, has admitted that post-exposure use "is not currently an FDA-approved use of the vaccine, however, the vaccine may provide additional protection by inducing an immune response to the anthrax organism."
"As an investigational new drug, the vaccine would need to be administered with the full informed consent of the individual as to possible risks. Individuals would also be asked to take part in a follow-up study measuring the effect of the vaccine when administered after exposure."
Therein the rub: the nature and completeness of the informed consent.
A copy of the informed-consent document obtained by NewsMax says:
"You should not consider the vaccine to be a treatment for anthrax. The vaccine as given in this program has not been shown to give long-term protection against anthrax.
"Some people have reported serious chronic illnesses like Guillain Barre Syndrome (a muscle weakness disease), chronic joint diseases, or had miscarriages and infertility after getting the anthrax vaccine.
"Although unconfirmed, a recent preliminary study suggests that the vaccine may be linked with an increase in the number of birth defects when given during pregnancy. At this time no one knows for sure whether this vaccine can cause fetal harm."
But Smith, joined Thursday by the National Vaccine Information Center (NVIC), complained that CDC's anthrax vaccine consent form did not fully describe the serious adverse event reports associated with the anthrax vaccine.
Complications of the Vaccination They pointed to Army Surgeon General Ronald Blanck, who testified about possible conditions that followed vaccination, including Guillain-Barre syndrome, multiple sclerosis, angioedema, aseptic meningitis, severe injection site inflammation, bipolar psychiatric disorder, diabetes mellitus and systemic lupus erythematosus.
Furthermore, according to Smith, the informed consent being offered the postal workers is silent about the complaints levied by military service members who have taken the injections: anaphylactic shock, gastroparesis, primary testicular failure, chronic fatigue syndrome, fibromyalgia, Steven Johnson's syndrome, deep vein thrombosis, and other problems.
Said Smith: "New York Metro insists the 'informed consent' offered to postal workers must be truly informed. During your conference call announcement on December 18, Dr. Kathryn Zoon, director of the FDA Center for Biologic Evaluation and Research, cited data from the Vaccine Adverse Event Reporting System (VAERS) and characterized the reactions of military personnel from the anthrax vaccine as 'minor and temporary.'
"This statement is deliberately misleading, and cannot suffice as informed consent about the real and serious adverse reactions associated with this vaccine. To provide inadequate risk/benefit data to prospective recipients is medical malpractice.
"I therefore request that you make all VAERS reports filed on the anthrax vaccine immediately available on the CDC and FDA websites so that the physicians and patients, on whom you have placed the burden of recommending or using this vaccine, are truly informed."