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Subject: Court Orders Detailed Anthrax Shot Procedure After Error in Iraq - Sep 1, 2005 & Soldier Falls Ill After Taking Vaccine Shots

Copyright 2005 Inside Washington Publishers
All Rights Reserved
Inside the Pentagon
September 1, 2005
SECTION: Vol. 21 No. 35

LENGTH: 826 words



A federal judge who last year banned the Defense Department from giving service members involuntary anthrax vaccines has ordered the Pentagon to circulate detailed instructions to medics around the globe to ensure they have obtained a patient's permission before administering a shot.

The new directive follows a report the Bush administration delivered to the U.S. District Court saying "that an involuntary anthrax vaccination was administered at a U.S. military medical clinic in Iraq, in violation of this Court's injunction," in the words of a "minute order" Judge Emmet Sullivan issued Aug. 30.

After a seven-month hiatus, the Pentagon resumed giving anthrax vaccines under "emergency" authority -- strictly on a voluntary basis -- beginning in May (Inside the Pentagon, May 5, p5).

The Defense Department is the lead defendant named in a lawsuit filed in March 2003 by six anonymous DOD employees who were subject to then-mandatory shots. Following summary judgment in favor of the plaintiffs that resulted in a permanent injunction against the involuntary shots program, the administration has appealed to a higher court, where the case is now pending (ITP, May 19, p1).

However, Sullivan retains the ability to compel compliance with his ruling, as reflected by the new minute order.

In it, he notes that following the errant injection, the commanding officer of the medical unit in Iraq issued a memorandum to his subordinates on how to avoid additional involuntary shots. The Pentagon detailed the commander's memo in a July 22 filing to the court.

Sullivan this week ordered the Pentagon to circulate those same military instructions "by no later than Sept. 15, 2005, to all medical staff administering vaccines."

Wording from the commander's memo, now to be distributed to medics worldwide, reads: "If administering anthrax vaccination, ensure the patient has signed in, received training and trifold [brochure], understand [sic] the right to refuse, and states they want to receive the anthrax vaccine. Immediately prior to administration of the anthrax vaccination (once site and vaccine are prepared), ask the patient, 'Do you want to receive the anthrax vaccination?' If the patient confirms, administer."

Sullivan's minute order comes on the heels of a "reply brief" the administration filed late last week at the U.S. Court of Appeals in response to the plaintiffs' initial brief to that court in July (ITP, Aug. 4, p1).

"Plaintiffs provide no basis for sustaining the district court's injunction," Justice Department lawyers argue in the document on the Pentagon's behalf. "Even if the district court were correct on the merits, there is no basis for its sweeping, military-wide injunction. The court's injunction is wholly unnecessary to provide relief to the six plaintiffs, and, without providing any gain in safety, it improperly sets aside the military's judgment as to the optimal means for protecting American service members against the threat of anthrax."

The plaintiffs have long asserted that the anthrax vaccine manufacturer's submission of an application to certify the product for the prevention of inhalational anthrax demonstrates the vaccine was not previously labeled for that use. The question of whether the Food and Drug Administration has approved such a use is central to the case, given that the Pentagon administers the drug to counter the threat of an biological attack from airborne anthrax spores that could infect a victim's lungs.

The existing vaccine label is not specific about the route of disease exposure against which it protects. But the plaintiffs have argued the underlying research focused almost exclusively on mill workers and laboratory technicians whose risk of contracting anthrax was primarily through the skin.

The submission of an application for the FDA to consider the anthrax vaccine an "investigational new drug" for the purpose of preventing an inhaled route of exposure "was not triggered by any regulatory action on the part of the FDA, nor could its filing by the manufacturer purport to speak on behalf of the FDA as to the scope of [the anthrax vaccine] license," the government argues in the new brief.

Citing FDA statements that the vaccine label does not preclude the Pentagon from administering the vaccine to service members for prevention of inhalational anthrax, the government states, "The reasonableness of FDA's conclusion is all the more apparent given that inhalation anthrax is a deadly disease and that the vaccine was found to be safe."

The plaintiffs have maintained that FDA officials' statements in support of the Pentagon program are not a sufficient substitute under the law for the agency's formal process of properly certifying the vaccine for use against inhaled anthrax, a view Sullivan supported in deciding the case last year. Since his ruling, the FDA has initiated such a process and formal certification is widely expected in the coming weeks. -- Elaine M. Grossman
Soldier Falls Ill After Taking Vaccine Shots
POSTED: 11:48 am CDT September 1, 2005
UPDATED: 12:06 pm CDT September 1, 2005
ALVA, Okla. -- An Oklahoma National Guard soldier says he faces mounting medical costs and is too sick to work because of a severe reaction he suffered to a battery of vaccines he was given in preparation for deployment to Iraq.
Spc. Kent Stewart, 37, of Alva, received the anthrax vaccine along with other members of his unit, the 45th Field Artillery Brigade, in February 2003 as they prepared for deployment to Iraq.
He said he began experiencing severe headaches. On March 15 he received the second series of shots. The third series followed April 4. He suffered dizziness and tingling on the left side of his face and in his hands and legs.
On May 27, the unit received notice their orders had been canceled.
Stewart received his fourth round of the vaccine on Dec. 7, 2003. Vomiting, weight loss, insomnia, and other symptoms started, including pancreatic problems. Each episode required treatment with antibiotics and other medications to ease the symptoms.
On Aug. 15, 2004, he received his fifth and last immunization. His condition worsened until he was hospitalized Nov. 22, and placed on intravenous antibiotics for a week.
Stewart's doctor, Tarek Naguib, said the immunizations are a suspected cause of Stewart's medical problems.
Col. Pat Scully, the Oklahoma National Guard spokesman, said he was not familiar with Stewart's case but said there should be treatment Stewart can pursue through the military medical system.
"I've been through the series of anthrax shots and have had no problem but that doesn't mean the soldier doesn't have a valid complaint," Scully said.
About one person in 100,000 has a serious adverse reaction to the vaccine, according to the Pentagon.
The military now gives the vaccine to soldiers only on a volunteer basis after a judge found fault in the Food and Drug Administration's process for approving the drug. Previously, hundreds of people were kicked out of the military for refusing the shots out of safety concerns.
Stewart said the injections were mandatory when he took them. He said he was told that he would be given a dishonorable discharge or a bad conduct dismissal if he were to refuse.
"I felt the shots weren't going to be doing any good," he said. "I didn't personally think there was that big a threat."