Judge rules military can require anthrax shot

[thedrifter]

Judge rules military can require anthrax shot
By Matt Apuzzo - The Associated Press
Posted : Friday Feb 29, 2008 11:07:10 EST

WASHINGTON — The Pentagon can require its troops be vaccinated against anthrax, a federal judge said Friday.

Judge Rosemary M. Collyer said the Food and Drug Administration acted appropriately when it found the vaccine to be safe and approved its use. She dismissed a lawsuit by military officials who argued the drug is unproven and the scientific data unsound.

“The court will not substitute its own judgment when the FDA made no clear error of judgment,” Collyer wrote.

The dispute has languished in the court system for years. A federal judge suspended the vaccination program in 2004 after faulting the FDA’s process for approving the drug. After the FDA redid the process and again found it to be safe, the military announced plans to reinstate mandatory vaccinations.

That prompted this latest lawsuit by eight military members who argued the vaccine should be optional. A message seeking comment was left with Mark Zaid, an attorney for the plaintiffs.

The Pentagon continues to require the vaccine, saying the program is necessary to protect troops from anthrax attacks.

“We owe it to our service members to give them every possible protection,” said Pentagon spokesman Bryan Whitman. “Force protection is the number-one priority in the Defense Department and the anthrax inoculation program is an important force-protection measure.”

Ellie

[thedrifter]

Article published Mar 1, 2008
Judge rules anthrax vaccine safe, needed


March 1, 2008

By Jerry Seper - A federal judge's ruling yesterday that a Food and Drug Administration-approved anthrax vaccine is safe means the U.S. military can again start vaccinating its soldiers, sailors and Marines.

U.S. District Judge Rosemary M. Collyer of the District of Columbia, in a 21-page opinion, said that after examining the available scientific data, the FDA applied its expertise and found that the vaccine, Anthrax Vaccine Adsorbed or AVA, is "effective for immunization against anthrax."

Judge Collyer dismissed a lawsuit brought by eight members of the military who argued the vaccine was unproven and that studies describing its safety were unsound. They wanted the vaccinations to be optional.

"The FDA did not act arbitrarily or capriciously," the judge said. "It considered the relevant data and articulated an explanation establishing a 'rational connection between the facts found and the choice made.' The court will not substitute its own judgment when the FDA made no clear error of judgment."

A legal battle over the mandatory vaccination program has been ongoing for years. U.S. military personnel subject to the shots expressed concern about the vaccine's side effects and brought lawsuits to stop the program.

Beginning in 1998, the Clinton administration required the vaccination of all military members against anthrax, despite the fact the FDA had written a warning letter to the vaccine's manufacturer, BioPort Corp. in Lansing, Mich., threatening to revoke its product licenses unless immediate action was taken to correct deficiencies.

In June 2001, the Defense Department halted the vaccination program due to non-FDA approved changes in BioPort's manufacturing process. A year later, after the anthrax attacks in Florida, the District, and New York, all military personnel were required to get an anthrax vaccination, but in April 2004, the department made the shots voluntary after U.S. District Court Judge Emmet G. Sullivan in Washington ruled against the mandatory shots unless through a special order by the president.

The Defense Department resumed the program on a voluntary basis in April 2005 and, eight months later, the FDA completed a final investigation of the vaccine and reaffirmed its earlier finding that it was safe and effective. In October 2006 the Pentagon again made the shots mandatory for personnel serving in the Middle East and South Korea. About 1.8 million troops have received the anthrax shots since the program began.

Yesterday's ruling involved a lawsuit filed Aug. 15, 2007, by Air Force Lt. Col. Thomas Rempfer; Navy Lt. Cmdr. Joshua Cohen; Navy Reserve Lt. Cmdr. Gareth Harris; Army Staff Sgt. Kevin Ferrara; Army Spc. Shameka Edwards; Army Pfc. Eric Gearhart; Navy Airman Michael Palmer; and Merchant Marine Seaman James Hailstone.

Charging that the government failed to properly certify the Pentagon-mandated anthrax vaccine, the eight military persons had refused orders to take it as part of their military duties or employment obligations, or had been administered it in violation of what they described as the FDA's "mandated shot sequence protocol."

The Pentagon has said the vaccine is necessary to protect against anthrax attacks.

"We owe it to our service members to give them every possible protection," said Pentagon spokesman Bryan Whitman. "Force protection is the number-one priority in the Defense Department and the anthrax inoculation program is an important force-protection measure."

But Mark Zaid, an attorney for the plaintiffs, told reporters that the FDA relied on outdated studies to show the vaccine is safe and said he planned to appeal the ruling.

"It would appear the court has condoned an agency's manipulation of decades-old data to support a present-day policy objective," Mr. Zaid said.

Ellie