A Soldiers Blog

U.S. Barred From Forcing Troops to Get Anthrax Shots

By Marc Kaufman
Washington Post Staff Writer
Thursday, October 28, 2004; Page A01

The Defense Department must immediately stop inoculating troops with anthrax vaccine, a federal judge ruled yesterday, saying that the Food and Drug Administration acted improperly when it approved the experimental injections for general use.

Concluding that the FDA violated its own rules by approving the vaccine late last year, U.S. District Judge Emmet G. Sullivan said the mandatory vaccination program -- which has inoculated more than 1.2 million troops since 1998 -- is "illegal."


Sullivan said that his ban on involuntary vaccination will remain in place until the FDA reviews the anthrax vaccine properly or until President Bush determines that the normal process must be waived because of emergency circumstances.

The Defense Department has required many troops serving in Iraq and Afghanistan to be vaccinated, and it has punished and sometimes court-martialed those who refused. The Pentagon expanded its anthrax and smallpox vaccination programs in July to include troops stationed in South Korea and other areas in Asia and Africa, despite complaints from some service members that the anthrax vaccine made them sick.

In a statement, the Defense Department said it is reviewing the decision and will "pause giving anthrax vaccinations until the legal situation is clarified. . . . DoD remains convinced that the anthrax immunization program complies with all the legal requirements and that the anthrax vaccine is safe and effective."

In his ruling, Sullivan said that the FDA's approval was invalid because it did not meet the required review standards and the agency failed to seek the necessary public comment.

"Congress has prohibited the administration of investigational drugs to service members without their consent," Sullivan said. "This Court will not permit the government to circumvent this requirement."

"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. This is the process the FDA in its expert judgment has outlined, and this is the course this court shall compel FDA to follow," Sullivan wrote.

The judge ruled on a suit filed in March 2003 by six service members and civilians who argued that the FDA never properly reviewed the vaccine's ability to protect against inhalation anthrax. The suit contended that the drug was never shown to be effective, and that some vaccinated troops experienced extreme fatigue, joint pain and temporary memory loss after being vaccinated. The vaccine, made by BioPort Corp. of Lansing, Mich., is given in a series of shots.

Mark Zaid, an attorney for the six who has also defended more than a dozen service members court-martialed for refusing the vaccination, said one of his clients is a breast-feeding mother who does not think the vaccine is safe for her child.

"We will now initiate an effort to ensure the government reverses all punishments that were imposed for refusing an order to take the vaccine," Zaid said. He said he will also seek compensation for service members who contend they were harmed. "As we've seen in Iraq, there wasn't any actual threat from anthrax, so there was never any real need for the vaccine," Zaid said.



U.S. Barred From Forcing Troops to Get Anthrax Shots (washingtonpost.com)