Bush Admin. Wants to Waive Rules in Vaccine Manufacturing

Anthrax Vaccine Network, Inc.
P.O. Box 844
Missoula, MT 59806
1-888-411-3200
Email: contact@anthraxvaccine.net
CONTACT: Kathy Hubbell, President – (888) 411-3200 OR
Sonnie Bats, Vice-President – (302) 381-2775

FOR IMMEDIATE RELEASE: DEC. 18, 2001

ANTHRAX VACCINE NETWORK ISSUES FORMAL PROTEST AGAINST
REQUEST TO WAIVE FDA RULES IN VACCINE MANUFACTURING;
AND AGAINST USING ANTHRAX VACCINE AS A PUBLIC EXPERIMENT

The Anthrax Vaccine Network, Inc. (AVN) today issued a formal protest against the "height of immorality, stupidity, and lack of concern for the public health" as represented by the request of drug companies and the Bush Administration to waive FDA rules in vaccine manufacturing, and to use stockpiled, expired, and quarantined doses of the highly reactive, dangerous anthrax vaccine on the American public, according to AVN President Kathy Hubbell. In response to a New York Times article on Dec.11, 2001, about the bioterrorism bill now before Congress, Hubbell noted that, according to the story, "Drug companies and the Bush administration have told Congress that rules of the Food and Drug Administration may interfere with the production of drugs and vaccines needed in a public health emergency. So, they say, the secretary of health and human services should be able to waive those rules to ensure that a sufficient supply of drugs will be available."

"When asked for examples, administration officials said they might want to suspend rules for the testing and labeling of drugs, vaccines, blood and blood products. Also, they said, the government may want to waive quality?control standards, "good manufacturing practices" and rules that require drug makers to notify the government of any serious illness or injury caused by the use of their products."

In the case of the current anthrax vaccine, Hubbell further noted, good manufacturing practices haven't been followed in the first place, and BioPort, the vaccine's manufacturer, certainly has not notified the government about the serious illness, injury and death caused by use of its products. This, she says, is part of the underlying problem in the government's stated wish to vaccinate a portion of the population with the anthrax vaccine on an experimental basis, with informed consent. Not only is the government proposing to use vaccine manufactured by the same company cited numerous times for quality control, lack of sterility in its products, the use of contaminated products, and withholding from the FDA the information that the company changed its filtering and fermenting equipment, resulting in a 100-fold deviation in potency of the vaccine; but that same government has already conducted a massive anthrax vaccine experiment, and has all the information it needs at its disposal. That experiment is the one conducted upon the troops in the armed services since at least 1989, with the current anthrax vaccine which has been on file with the FDA throughout this period as an Investigational New Drug, requiring informed consent by law. But no member of the military has ever been granted their legal right of informed consent; troops who have refused have instead been fined, put in the brig, court-martialed, and usually dismissed from the service under less than honorable conditions.

In addition, notes Hubbell, the Dept. of Defense, BioPort, the FDA, and the Centers for Disease Control have steadfastly refused to establish a national register of those who have taken the vaccine in order to track their reactions. One possible problem with this is that the national register, when made public, will show reactions ranging from severe joint and bone pain, to chronic fatigue, grand mal seizures, blackouts, brain lesions, tumors and cysts, the lack of the body's ability to produce testosterone in some men, severe menstrual and reproductive problems in some women, internal organ problems, chronic autoimmune illnesses and death.

"They have already decimated and demoralized thousands of our troops with this grand medical experiment," Hubbell said. "Troops who are medically discharged because they are so ill from the vaccine they can no longer work may or may not receive adequate medical care and VA benefits.

Some will never be able to work again. Yet this is the vaccine they are unleashing on the American public. The stockpiled vaccine is adulterated and misbranded, a well established fact, which was reiterated by retired FDA regulator and inspector Sam Young in his testimony before the Institute of Medicine last week. There are reasons it's been quarantined. We caution all Congressional staffers and others who are targeted to take this vaccine. If they want to volunteer for this grand medical experiment, that is their choice. But let's be honest about the devastating results in the military, and let's track results now. Let's see who is incapacitated for life, and who dies. Let's have them fight the physicians for an accurate diagnosis and for medical benefits. Let's tell them they are not allowed to sue because they signed an informed consent. Then let's casually drop our concern with FDA rules and good manufacturing practices."

 


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