posted 03-23-2003 10:08 AM            

Alleges drug is untested, causes adverse reactions
http://www.theinquirer.net/?article=8406

By INQUIRER staff: Wednesday 19 March 2003, 16:36

A CASE HAS BEEN FILED IN the US District Court for the District of Columbia against the Department of Defense, Donald Rumsfeld and members of other government departments claiming that an anthrax vaccination for US troops and civilian employees violates federal law.

The case claims that Anthrax Vaccine Adsorbed (AVA) is being involuntarily administered to active and reserve US armed force members, is an investigational new drug or a drug unapproved for its intended use.

The plaintiffs are active duty service members, National Guardsmen and DoD civilian contract employees, and others.

The main defendant is the US Department of Defense, represented by the Secretary of Defense, Donald Rumsfeld.

The suit claims that since 1998 the DoD has administered mass inoculations to troops and others without seeking the informed consent of the individuals receiving the injections.

The case also names the Department of Health and Human Services as well as the Food and Drug Administration in the case.

The suit said that AVA was originally licensed as a vaccine against anthrax in 1970, but quotes a Department of the Army report as saying that AVA was reactogenic, needed multiple boosters to maintain immunity, and "might not protect against all strains of anthrax".

The FDA, the suit alleged, failed to finalise the licensing of AVA as a vaccine, and further claims that AVA is not licensed for use against inhaling anthrax bacilli.

It claims that Federal Law prohibits investigational new drugs from being administed to members of the Armed Forces without their prior consent, unless a waiver is signed by the President of the US.

It claims the FDA included a number of adverse reactions to the AVA inoculation including autoimmune disorders, birth defects and other adverse reactions, which were never disclosed to members of the armed services.