The program, which used a product called Anthrax Vaccine Absorbed, has been at the center of three lawsuits, a congressional investigation and some 100 courts-martial of personnel refusing administration of the vaccine. Critics of the program say the medication caused serious illness in a number of people and is not approved for the prevention of inhalation anthrax, an infection feared by those trying to anticipate and forestall deaths from bioterror attacks.
The DOD and vaccine manufacturer Bioport, of Lansing, Mich., assert the vaccine is safe. They point to 18 studies, including one by the Institute of Medicine -- part of the National Academy of Sciences -- saying the vaccine is no more dangerous than any other vaccine.
Federal District Court Judge Emmet Sullivan agreed with critics and granted an injunction Oct. 27 against the mandatory program for a second time, pending proper approval of the vaccine for inhalational anthrax. Though it was still possible to give soldiers the vaccine with their informed consent, Defense Secretary Donald Rumsfeld immediately halted the program and it has been suspended since that time.
Now, in a nine-page question-and-answer brief on the anthrax vaccine, DOD said it is in discussions with the Department of Health and Human Services over whether or not the program can be resumed on a mandatory basis.
In answer to a specific question regarding the possible mandatory or voluntary nature of the program, the brief said, "Specific details on program resumption, if granted under an EUA, are still being discussed between the Departments of Defense and Health and Human Services."
Lawyers for plaintiffs in the case that led to the injunction against the program have long asserted the only mechanism available to restart the vaccination effort on a mandatory basis was a waiver of informed consent issued by President George W. Bush.
"Once they have the authorization to use it, the secretary still has to ensure that those getting the vaccine have the option to accept or refuse," said John Michels, an attorney with the law firm McGuire Woods in Chicago. "Our position is that you can't administer the vaccine without the president."
"This is something we are working out ...with HHS and FDA," a DOD spokesman told United Press International when asked if a mandatory program was being sought. "It is a process that is ongoing. It will require additional discussion between us and HHS over the next few weeks."
Lawrence Halloran, staff director and counsel for the House Subcommittee on National Security, said he did not know how, "under the law as written, HHS could grant Emergency Use Authorization for an approved drug, for an unapproved use and not include as a condition of that authority the obligation to notify recipients of the right to refuse it."
Halloran also told UPI: "DOD somehow thinks that HHS can do that. Under what circumstances I don't know. They seem to have some legal theory they're not sharing with us yet."
DOD asserted in a Dec. 10 request to Thompson for the waiver that a potential emergency exists for the troops.
"I have determined there is a significant potential for a military emergency involving a heightened risk to the United States military forces of an attack with anthrax," wrote Deputy Secretary of Defense Paul Wolfowitz. "In making this determination, I have considered a classified 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 serving in the areas of Central Command and Korea."
The areas of Central Command include Iraq and Afghanistan.
Under the steps outlined in the brief, HHS first would approve the EUA, followed by the Food and Drug Administration evaluating evidence for its safety and effectiveness. The FDA then would grant or deny approval.
The evidence for the vaccine, the brief said, would be submitted by DOD's assistant secretary of defense for health affairs.
The EUA would be in effect for up to one year. The people most likely to be vaccinated would include those with duty assignments in Iraq, Afghanistan and Korea, as well as others with special assignments and laboratory personnel.
The Q and A said side effects would be monitored and military personnel would be informed of possible reactions and asked to report any problems. HHS and FDA also would "review" the program periodically.
The Q and A does not mention informed consent in its description of the brochures that would be given to medical personnel and those receiving the vaccine. Nor does it mention that DOD is required to notify recipients of their right to refuse, as required by the National Defense Authorization Act of 2004.
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