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U.S. Defense Department Accused of ‘Disinformation’ on Anthrax Vaccine Program

By David Ruppe
Global Security Newswire

WASHINGTON — Lawyers for six plaintiffs who last month secured an injunction barring anthrax vaccinations of U.S. military personnel without informed consent yesterday accused the Defense Department of ‘disinformation’ on the ruling (see GSN, Oct. 28).

A statement released by attorneys Mark S. Zaid and John Michels said the Pentagon “has led a disinformation campaign to downplay the significance of the court’s decision, particularly regarding the length of time the injunction will remain in place.”

They charged specifically that the department has mischaracterized the injunction issued by U.S. District Judge Emmet Sullivan last month by depicting it as a temporary “pause” in mandatory vaccinations pending the resolution of a procedural question, rather than questions regarding the efficacy or safety of the vaccine.

The lawyers called the Defense Department statement “deliberately misleading” and said Sullivan’s injunction did in fact question the safety and efficacy of the vaccine.

Contacted today, Pentagon spokesman Army Lt. Col. Joe Yoswa said, “I believe we put a release out on that and I’ll let the release speak for itself.”

Meaning of the Injunction

That Oct. 27 release said, “The injunction did not question the safety and effectiveness of the anthrax vaccine or the immunization program in the DOD.”

“The injunction centered on FDA [Food and Drug Administration] procedural issues stating that additional public comment should have been sought before the FDA issued its final rule in December of 2003,” it said.

In apparent accordance with the release, Sullivan’s ruling did appear to hinge on the procedural issue of public comment.

“In this case, the court focuses not on FDA’s substantive — and highly technical — determinations regarding the safety of [the vaccine], but rather on whether or not the agency observed the relevant ‘procedure required by law,’” it said.

Sullivan found, however, that because of nonconformity with procedure, the vaccine must be considered investigational and could not be deemed safe and effective until a public comment period was conducted.

“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,” he wrote.

“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 wrote, ordering the FDA to reconsider its ruling and allow public comment on approval of the anthrax vaccine.

The plaintiffs in their suit questioned the interpretation of studies the FDA used to conclude that the vaccine is effective against inhalation anthrax, and noted the vaccine was originally intended for protection against the skin form of anthrax.

“In fact, given the state of the medical and scientific evidence, it will be extremely difficult for [the] FDA to make a proper case that the vaccine has any effectiveness against inhalation anthrax,” Zaid said in yesterday’s statement.

Sullivan ruled preliminarily last December that the vaccine was investigational and not licensed to protect against inhalational exposure, but rather only for protection against the skin form of anthrax. He concluded the vaccine by law could not be given without either informed consent or a waiver by the president (see GSN, Dec. 29).

Inoculations resumed shortly afterward when the Food and Drug Administration released a final ruling without a formal public comment period that the vaccine is “safe and effective for the prevention of anthrax disease — regardless of the route of exposure.” That decision — based on an 18-year-old application — allowed vaccinations to resume without informed consent until Sullivan’s order last month.

Though Sullivan’s injunction only barred vaccinations without informed consent, Defense Secretary Donald Rumsfeld last month ordered all anthrax vaccinations to stop “until further notice.” The government has indicated it will seek to vacate the Sullivan’s injunction.

Possible Implications of DOD’s Characterization

According to Zaid and Michels, the DOD’s “disinformation campaign” regarding Sullivan’s latest ruling is significant because it suggests to troops that the safety and effectiveness off the drug is not in question.

“It does mislead, not just the public, but the soldiers who are asked to take this vaccine,” Michels told Global Security Newswire today.

The lawyers in their statement also wrote that soldiers forced to the leave the military for refusing to take the vaccine should be allowed to return and be compensated.

“Our position is that the soldiers haven’t been informed about the nature of the vaccine from day one,” he said.

The Defense Department statement last month said the vaccine was determined safe and effective for all forms of anthrax exposure by “research conducted by several prominent medical experts and a report by the National Academy of Sciences.”

“As a result of the injunction, the Department of Defense will pause giving anthrax vaccinations until the legal situation is clarified,” according to last month’s statement.