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, Michigan 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.
Sullivan initially ruled in late 2003 that the FDA had never approved the vaccine and ordered that the inoculations be stopped. Eight days later, the FDA approved the vaccine based on an application made 18 years earlier, and the inoculation program was resumed. Yesterday's ruling concluded that the agency did not follow its own rules in declaring the vaccine safe and effective.
In particular, Sullivan criticized the FDA for not allowing the public to comment on its decision, a prerequisite for any approval. There was some public comment when the approval was first sought in 1986, but the 2003 decision was based on research conducted later and never subjected to public comment.
The FDA argued that comments had been submitted as part of a 2001 citizens' petition questioning proposals to begin the vaccinations, but Sullivan found them insufficient. "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.
Because the anthrax agent is so deadly, it has been difficult to test a vaccine that might protect against it. The best data has come from a study in the 1950s of workers at a factory that processed animal hides and furs, which can transmit naturally occurring anthrax. That study found that the vaccine now used by the military was effective in reducing the incidence of anthrax spread by contact, but the research involved only a tiny sample of people who might have inhaled the bacteria.
Anthrax vaccine was used in a limited way in the 1991 Persian Gulf War. A more expansive effort began in 1998. Difficulties in manufacturing the vaccine stopped the program in 2000 and 2001, but the vaccination effort was resumed and greatly expanded in 2002.
Staff writer Bradley Graham and researcher Madonna Lebling contributed to this report.