Court Orders Pentagon to Stop Anthrax  Vaccinations
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 Court 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.

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 have 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. 

RULING:

_http://www.airforcetimes.com/content/editorial/pdf/102704anthrax_decision.pdf
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