Judge Halts Mandatory Anthrax Vaccination For Military
October 28, 2004
By THOMAS D. WILLIAMS, Courant Staff Writer

A federal judge in Washington on Wednesday ordered the Department of Defense to stop requiring mandatory anthrax vaccination for military personnel because the drug has not been declared safe or effective for military use.

Judge Emmet G. Sullivan ruled the anthrax vaccine is either "a drug unapproved for its intended use, or an investigational new drug." Pentagon officials need to obtain the informed consent of each service member inoculated or a presidential waiver to allow its continued use, the judge ruled.

He remanded the Food and Drug Administration's finding that the anthrax vaccine is effective against aerosolized or inhaled anthrax for reconsideration. The vaccine was originally developed to fight anthrax infection absorbed through the skin.

In January, Sullivan had lifted a preliminary injunction against military use of the vaccine after the FDA asserted the vaccine was effective against anthrax spores absorbed through the skin.

Six unidentified members of the military, who said their forced use of the vaccine violated their rights, filed the lawsuit alleging that studies supporting the vaccine's use against inhaled anthrax are statistically invalid. Thousands of service members have voiced concerns about the vaccine's adverse side effects.

"We're ecstatic," said Mark Zaid, the attorney for the service members. "It validates our position of six years that the program was illegal and ill-conceived from day one."

Justice Department spokesman Charles Miller said the government was reviewing the anthrax decision and has made no decision yet whether to appeal.

Defense Department officials have maintained the vaccine is essential to protect the troops from enemy biological attacks. However, service members, their advocates and vaccine critics say there is no evidence U.S. enemies or terrorists are intent upon using anthrax spores. Those spores that were mailed throughout the U.S. in the letter attacks of 2001 were suspected to have originated from a U.S. laboratory, and not from foreign terrorists.

Former Secretary of Defense William Cohen instituted the mandatory program in 1997 to require all 2.5 million service members to take the vaccine. An estimated 1 million service members have received all or part of the six-shot series and regular booster shots.

"DoD remains convinced that the (vaccination program) complies with all legal requirements and that anthrax vaccine is safe and effective," Secretary of Defense Donald Rumsfeld wrote Wednesday in a memo to top Pentagon officials.

But Rep. Christopher Shays, R-Conn., whose House National Security subcommittee held hearings on the issue, said his panel came to the same conclusion as the judge.

"Unless and until the Food and Drug Administration conducts a fully open process to evaluate the current vaccine, the men and women in the armed services must have the same basic rights as every citizen to decide what goes into their bodies," Shays said.

Anthrax develops from a disease in cattle and sheep. Humans can contract the illness from breathing or ingesting the spores or through skin contact with infected animals. The original vaccine, developed by Merck in 1970, was aimed at protecting farmers, sheep wool workers and veterinarians from contracting the disease through skin contact.

Later, the State of Michigan's Health and Human Services Department began developing the drug under Merck's license through an entity known as MBPI. MBPI was criticized repeatedly in FDA inspection reports for unsafe manufacturing processes.

The Defense Department eventually contracted with MBPI to use the vaccine for protection against inhaled anthrax spores in the first Persian Gulf War. In 1998, BioPort Corp. of Lansing, Mich., purchased the operation from MBPI.

Since the vaccinations began six years ago, nearly 500 active-duty service members have refused the vaccine and more than 100 have been court-martialed, according to data filed in federal court. About 500 to 1,000 pilots and flight crew members have retired or transferred from the Air National Guard or reserves rather than take the vaccine, government statistics as of early 2004 show.

The FDA, Defense Department and BioPort have denied there are any harmful additives in the vaccine. But FDA warnings, developed from complaints by military vaccine users since 1998, state that adverse reactions are expected in 5 percent to 35 percent of people who take the injection. That compares with the previous expected rate of 0.2 percent, established in the '70s and '80s.

Adverse vaccine reactions include immune disorders, muscle and joint pains, headaches, rashes, fatigue, nausea, diarrhea, chills and fever. At least a half-dozen deaths and a number of birth defects have been attributed to use of the vaccine. BioPort officials insist the vaccine is safe and effective.