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Anthrax vaccine opponents file new lawsuit

By Gayle S. Putrich
Staff writer
Dec. 13, 2006
http://www.marinecorpstimes.com/story.php?f=1-292925-2421027.php

The legal battle over the military’s mandatory anthrax immunization program has been revived, with six unnamed plaintiffs filing a class-action lawsuit against the government Wednesday.

According to court documents, the basic premise of the lawsuit is the plaintiffs’ claim that the vaccine is “unapproved for its applied/intended use.”

The lawsuit says that “plaintiffs will suffer substantial and irreparable injury if they are forced to take the vaccine,” which the suit says has not been properly approved by the government, despite the Food and Drug Administration issuing its “final rule” on the vaccine a year ago.

The suit also says the Defense Department has failed to follow presidential orders and federal laws that require the government to obtain informed consent before giving an unapproved and experimental vaccine to anyone.

“FDA’s certification of the vaccine, which is based on slipshod statistical analysis and improper use of testing data, as well as DoD’s alteration of the vaccine dosing schedule, render the vaccine a drug unapproved for its applied use under current federal law,” said Chicago lawyer John J. Michels, Jr., co-counsel in the lawsuit. “Under these circumstances, the vaccine may not be administered to service members without their informed consent. It is patently illegal.”

The new lawsuit is just the latest chapter in the long and turbulent history of the Pentagon’s anthrax vaccination program. Since December 2004, the six-shot anthrax vaccine has been optional for all troops following the decision of a federal judge for the U.S District Court for the District of Columbia to halt the mandatory program with an injunction.

In December 2005, the FDA finalized its approval of the vaccine and a federal appeals court dissolved the injunction, clearing the way for the Pentagon to resume mandatory shots.

The Pentagon announced in October that mandatory inoculations would resume, but defense officials are still formulating some parts of the vaccination plan, which is now expected to begin early next year. The policy announced in October directs mandatory anthrax shots for troops, emergency-essential civilians and Defense Department contractors carrying out mission-essential services in the Central Command area or South Korea for 15 consecutive days or more. Others assigned to special mission units, such as biodefense units, are also expected to be vaccinated as needed under the new policy.

As in the first anthrax vaccine lawsuit, the five male and one female plaintiffs are unnamed — out of “fear of retaliation by the government,” their lawyers say. Court documents claim they run the gamut of those who will be required to take the vaccine after the new year: active-duty service members, reservists, National Guardsmen, civilian Defense Department employees and contractors.

Robert Gates, who will be sworn in as defense secretary Monday, replacing Donald Rumsfeld, is named in the lawsuit, along with Heath and Human Services Secretary Mike Leavitt and Andrew C. Von Eschnebach, commissioner of the Food and Drug Administration.

The Defense Department had no immediate comment on the lawsuit Wednesday morning.

Pentagon officials have long maintained that the anthrax vaccine is safe, and say that the 2005 FDA ruling grants them the legal authority to administer the vaccine as they see fit. Only about half of the troops offered the vaccine during the voluntary phase of the program have taken the shots, and officials say it is a preventive-medicine and military-readiness concern for half of the force to be vaccinated and half not to be, officials have said.

“This rate of vaccination not only put service members at risk but also jeopardized unit effectiveness and degraded our medical readiness,” said Dr. William Winkenwerder Jr., assistant secretary of defense for health affairs, in announcing the resumption of mandatory shots in October.