From the January 2004 Idaho Observer:

DOD / Bioport resume forced anthrax vaccinations

Fed judge lifts injunction after “timely” FDA approval

compiled from reports

On November 26 Senator Jeff Bingaman (D-NM) introduced Senate Resolution 278, asking the Pentagon to reconsider its requirement that all military personnel receive six doses of the experimental anthrax vaccine. This Resolution states several acknowledged problems with the anthrax vaccine. A few of these are:

1. Eighty-four percent of military personnel who had the anthrax vaccine from 1998 to 2000 had side effects or reactions. And 24 percent of these were systemic.

2. The General Accounting Office recorded that, “69 percent of experienced pilots and aircrew members in the National Guard and the Reserve reported that the anthrax shot was the major influence in their decision to change their military status in 2000, including leaving the military entirely.”

3. In the Iraq war, our allies did not have a mandatory anthrax vaccine program: Both British and Australian militaries have voluntary programs and our other allies have no anthrax vaccine program in place.

4. According to former FDA official and retired U.S. Army Colonel Sam R. Young, the anthrax vaccine has never been proven to be effective against anthrax. Dr. Young was once the director of compliance in the drug regulatory process at the FDA and has vocalized the fact that the FDA has never “approved” of the anthrax vaccine.

5. In March 2000, the National Institute of Allergy and Infectious Disease reported in the “Jordan Report 20th Anniversary: Accelerated Development of Vaccines 2000” that there is no existing data which supports the effectiveness of the anthrax vaccine against pulmonary (inhalation) anthrax in humans. This admission alone makes the anthrax vaccine illegal.

The resolution asked Defense Secretary Donald Rumsfeld to:

1. reconsider the “mandatory nature” of the vaccine programs

2. reconsider punishments administered against personnel who refused the vaccine

3. to reevaluate the anthrax threat in Iraq

4. to assess current reports of effects of the vaccines with a view to funding medical treatment for them.

These seem like modest requests in view of the fact that one organization of Gulf War vets has asked Rumsfeld to resign.

With Rep. Henry Waxman (D-CA), Bingaman also wrote a letter to the White House on July 11, 2003, requesting that the vaccine policy be reconsidered. Neither the White House, the Pentagon nor the military took action as a result of this letter.

Renewed controversy

On December 22, 2003, Judge Emmet Sullivan, a U.S. District Court judge for the District of Columbia, ordered the Pentagon to stop its mandatory anthrax vaccination program, saying the inoculation is an experimental drug and military personnel should not be used as “guinea pigs.”

The case was filed in April by six unidentified troops and Department of Defense (DOD) civilian workers who challenged the Pentagon's mandatory anthrax vaccine policy.

Sullivan's decision was based on the fact that Congress, after the 1991 Gulf War, passed a law banning the use of experimental drugs on military personnel without their informed consent. Federal law also allows the president to waive this law.

In a preliminary injunction, he ruled that the vaccine used in the Pentagon's mandatory program was an “investigational drug” being used for an unapproved purpose.

The Pentagon said the next day it would administer the vaccine only on a voluntary basis until the legal issues were sorted out.

On December 30, 2003, just eight days after the court's decision and, after 18 years of inaction on this matter, the U.S. Food and Drug Administration (FDA) said the anthrax vaccine was safe and effective for use in protecting U.S. troops against inhaled exposure to the potentially deadly bacteria, despite the lack of scientific studies proving such protection.

This “timely” FDA action prompted the Justice Department to file a motion asking the court to lift the ban on mandatory anthrax shots.

Foregone conclusions

The Bush administration also asked for a stay of the order for all service members except the six plaintiffs while the court weighed the government's motion for a complete lifting of the ban.

Curiously, the DOD ordered $29.7 million worth of anthrax vaccine from BioPort, Corp., soon after Judge Sullivan barred the Pentagon from inoculating military personnel without their consent.

DOD Spokesman Bryan Whitman stated that the move demonstrates confidence that the anthrax vaccine program would resume as it did before the judge's order.

On December 31, 2003, the Pentagon said it will immediately resume compulsory anthrax vaccinations for U.S. troops soon after Judge Sullivan lifts the ban.

Then we hear that Judge Emmet Sullivan actually granted the request by the Bush administration by issuing a stay of his Dec. 22 order until a trial could be held.

In a two-page order, the judge called the timing of the FDA's action so soon after his earlier ruling “arguably highly suspicious.” Plaintiffs' lawyers accused the FDA of acting hastily due to political pressure from the Pentagon.

Sullivan said that, regardless of the timing, the FDA's action addressed his earlier concern that the agency had never categorized the vaccine as safe and effective against inhalation anthrax.

Sullivan left in place a prohibition on the Pentagon taking any action that would require the six plaintiffs to get the shots.

In a memo to DOD department leaders, Pentagon official David Chu said that the vaccination program “complies with all legal requirements, and there is now no judicial restraint” on giving the shots.

“Therefore, you should immediately resume the anthrax vaccination program,” Chu said.

Worried about possible dangerous side effects, hundreds of military personnel have rejected the anthrax shot since the program began in 1998. Many have been disciplined and some have been court martialed, forcing them out of the military.

Mark Zaid, a lawyer for the plaintiffs, expressed disappointment in the judge's decision but said he did not plan to appeal. Instead he said that, “We will be exploring the extent to which the Defense Department put undue pressure on the FDA.”

Bad faith

The plaintiffs filed an amended lawsuit shortly before midnight on December 30, 2003, calling the FDA's action “so arbitrary and capricious as to amount to bad faith.”

Zaid said the FDA ruling only served to confirm the vaccine had previously been used illegally by the Pentagon and that any troops or civilian contractors disciplined for refusing the shots had been unjustly punished.

The plaintiffs also notified the judge they may seek class-action status, which could allow more than 2.5 million active-duty, National Guard and Reserve troops and contractors to join the lawsuit.

According to DOD officials, about 1 million troops have been given the shots since the vaccination program began.

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