WASHINGTON — For the second time in a year, a federal judge ordered the military Wednesday to stop requiring anthrax vaccines (search) for U.S. military personnel
Thursday, October 28, 2004


In response, the Pentagon halted mandatory anthrax vaccinations "until further notice," but noted the court did not question the safety or effectiveness of the vaccine.

U.S. District Judge Emmet G. Sullivan said the Food and Drug Administration (search) violated its own procedures when it gave final approval to the vaccine last year because it failed to give the public an adequate opportunity to comment.

"The men and women of our armed forces deserve the assurance that the vaccines our government compels them to take into their bodies have been tested by the greatest scrutiny of all — public scrutiny," Sullivan said.

Justice Department spokesman Charles Miller said the government was reviewing the anthrax decision and has made no decision yet whether to appeal.

Six unidentified service members had sued the Defense Department, arguing that the vaccine is experimental and that it was being improperly used for inhalation anthrax as well as exposure

"We're ecstatic," said Mark Zaid, their attorney. "It validates our position of six years that the program was illegal and ill-conceived from day one."
After the ruling, the Defense Department said the program remained "an important force protection measure" but said it would temporarily suspend it as it did last year after a similar injunction.

"DoD remains convinced that the [vaccination program] complies with all legal requirements and that anthrax vaccine is safe and effective," Secretary of Defense Donald Rumsfeld (search) wrote Wednesday in a memo to top Pentagon officials.

Sullivan first ordered a halt to the mandatory vaccinations on Dec. 22, saying that vaccine was being used for an unapproved purpose. Eight days later, the FDA issued an order intended to give the vaccine final approval for use to prevent inhaled anthrax. Sullivan later lifted the ban, except for the six plaintiffs.

The soldiers had asked Sullivan to reinstate the prohibition. He agreed, rejecting the government's claim that the FDA had considered arguments against the vaccine.

"While some individuals may have submitted comments as part of a citizen petition, it is clear to this court that if the status of the anthrax vaccine were open for public comment today, the agency would receive a deluge of comments and analysis that might inform an open-minded agency," he said.

Without the FDA's final approval, the vaccine is considered investigational.

Congress has prohibited the military from giving investigational drugs to soldiers without their consent unless there is a presidential waiver.

More than 900,000 servicemen and women have received the shots, among the millions of doses of various vaccines administered to troops.

Hundreds of service members have been punished or discharged for refusing them, according to the Pentagon.









US Court: Forced Anthrax Vaccination Illegal - FDA's Approval Invalid

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On October 27, a federal court ruled against the US government for violating the right of military personnel to informed consent.
U.S. District Judge Emmet G. Sullivan ruled that the “involuntary anthrax vaccination program” by the Department of Defense is “illegal,” says Vera Hassner Sharav of the Alliance for Human Research Protection.

The Court ruled that the FDA’s approval of the anthrax vaccine for use on military personnel was invalid inasmuch as the FDA failed to comply with its own safety procedures. The Court found the FDA was in violation of the Administrative Procedures Act: “This Court has an obligation to ensure that FDA follow the law in order to carry out its vital role in protecting the public’s health and safety.” The Court ruling is a permanent injunction that will remain in effect "unless and until the FDA" obeys the law. Until that time, DoD's "involuntary anthrax vaccination program is rendered illegal."
The FDA is no newcomer to violating its own rules to please big business, taking health concerns in stride. It has done so when Donald Rumsfeld, then Chief Executive of Searl Pharmaceuticals, engineered the approval of Aspartame, a sweetener found in "light" soft drinks, bakery goods for diabetics and numerous other foods, over the express objections of the agency's own scientists. Aspartame has been called neurotoxic by several scientists, but FDA refuses to examine its own evidence of side effects.
FDA has also come under heavy criticism recently after covering up the adverse effects of psychiatric medications. The agency was recently forced to institute severe warnings on the labels of antidepressant drugs.
Read the Alliance for Human Research Protection's comments on the recent court decision, which really is a victory not only for the service personnel involved, but for all of those who think vaccinations as such are a damaging practice to be eliminated.
ALLIANCE FOR HUMAN RESEARCH PROTECTION
Promoting Openness and Full Discloure
www.ahrp.org









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