DoD seeks emergency approval to resume anthrax shots

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Dec 21, 2004 (CIDRAP News) – The US Department of Defense (DoD) has asked for emergency authority to ignore a recent court ruling and resume vaccinating military personnel against anthrax because of what is described as an increased risk of attacks on US forces.

A federal judge ordered DoD to stop the vaccination program in October on grounds that the Food and Drug Administration (FDA) had not followed proper procedures in approving use of the vaccine to prevent inhalational anthrax.

In a Dec 10 letter, Deputy Secretary of Defense Paul Wolfowitz asked Health and Human Services (HHS) Secretary Tommy Thompson for permission to resume the vaccination program. Wolfowitz cited the Project BioShield Act of 2004 as giving Thompson authority to grant the permission.

"I have determined that there is a significant potential for a military emergency involving a heightened risk to United States military forces of attack with anthrax," Wolfowitz wrote in the letter, a copy of which was provided by HHS officials.

"In making this determination, I have considered a November 2004 Intelligence Community assessment of the anthrax threat. This heightened risk has been and continues to be the basis for the DoD program of vaccinating personnel in the areas of the Central Command and Korea." The letter does not give any details about the threat.

Wolfowitz asked Thompson to use his authority under Section 4 of the BioShield law, which says the HHS secretary can, in emergencies, authorize the use of drugs, medical devices, and biological products that have not been approved by the FDA.

The law says the HHS secretary can declare an emergency permitting the use of an unlicensed product if, among other circumstances, the secretary of defense determines that there is "a military emergency, or significant potential for a military emergency, involving a heightened risk" of attacks on US forces with a biological, chemical, radiological, or nuclear weapon.

Request under review
HHS officials are reviewing the DoD request, a department spokesman told CIDRAP News today. Marc Wolfson of the HHS Office of Public Health Emergency Preparedness in Washington wouldn't predict how or when HHS might respond to the request.

About 1.25 million military personnel have received anthrax shots since the vaccination program started in 1998, according to DoD, but some troops have refused the shots because of concern about side effects. The program was suspended after US District Judge Emmet G. Sullivan issued an injunction Oct 27 in a suit brought by six military members and military contractor employees.

Sullivan ruled that the FDA violated its own procedures by not asking for public comments before approving the anthrax vaccine, called BioThrax (formerly Anthrax Vaccine Adsorbed), for inahalational anthrax. The judge cited a 1998 law that bars DoD from forcing personnel to take investigational or unapproved drugs unless the president decides that their consent isn't necessary.

In suspending the program, DoD officials said they were still convinced that the vaccine is safe.

Congressman questions DoD move
Rep. Christopher Shays, R-Conn., has raised questions about the DoD request to resume giving the shots. In a Dec 16 letter to Thompson, Shays, vice-chairman of the House Government Reform Committee, said the request "presents a number of unique, potentially troubling, legal and procedural issues."

"It is essential that HHS consider this first request for Project BioShield Act authority carefully and with maximum public input to avoid even the implication that HHS will rubber stamp or give unquestioning, and undeserved, deference to DOD determinations on medical matters," Shays states in the letter.

"Such deference has not served our military well in the past, when DOD failed to meet conditions and commitments on the use of experimental products like pyridostigmine bromide," the letter continues. "How will the department ensure the rigor and transparency of its deliberations regarding this matter?"

Shays goes on to say that "hundreds of military service personnel have suffered adverse reactions to the vaccine" and asks whether HHS will have access to the recent intelligence about the anthrax threat to US forces.

The letter concludes by asking, "Does HHS now consider the current anthrax vaccine product labeling incomplete or misleading in that it fails to differentiate between approved use for cutaneous exposure and unapproved use for inhalational exposure?"

HHS announced in early November that it would buy 5 million doses of BioThrax for the Strategic National Stockpile of drugs and medical supplies for civilian use. At the same time, the department announced plans to buy 75 million doses of a new, not-yet-licensed anthrax vaccine to protect the public.

See also:

Oct 28, 2004, CIDRAP News story, "Court ruling again stops anthrax shots for US soldiers"

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