March 22, 2001

Attorney General Richard Blumenthal today urged Defense Secretary Donald Rumsfeld and Acting Food and Drug Administration (FDA) Deputy Commissioner Dr. Bernard Schwetz to eliminate the military's controversial Anthrax vaccination program (AVA). In letters to Secretary Rumsfeld and Commissioner Schwetz, Blumenthal argued the compulsory vaccination program is compelling military personnel, including members of the Connecticut Air National Guard, to "put either their health or their careers at risk."

"The United States Government so far has refused to recognize or appreciate the danger and the personal dilemma it is imposing on its military personnel, despite repeated concerns expressed about administering an unlicensed drug never proved safe or effective for humans. Unfortunately, and directly contrary to law, the AVA is being administered to military personnel under threat of imprisonment, loss of pay and discharge," said Blumenthal in his letter. "In effect, the military is forcing its personnel to serve as human guinea pigs for an unlicensed drug that has not been proven to be safe or effective."

Blumenthal noted that the only license for the manufacture of Anthrax vaccine, granted in 1970 to MBPI/Bioport Corporation, was obtained exclusively for agricultural and veterinary settings as protection against cutaneous (skin) contact anthrax, not Inhalation Anthrax (caused by inhalation of Anthrax spores). AVA's present use is inconsistent with its original licensing and is for a purpose that was never tested. The vaccine is therefore an Investigational New Drug (IND) under FDA regulations and may not be used on humans without their specific and informed consent, argued Blumenthal. Additionally, the mandatory vaccination of troops with a biologic product not licensed for its current use violates the Federal Food, Drug, and Cosmetic Act.

Blumenthal cited testimony given during a series of public hearings held by the House Subcommittee on Government Reform, which indicated that for years the FDA and the military knew that AVA could not be used in this manner. "Suddenly in 1997, DOD and the FDA, with no change in the facts or the law, reversed themselves and with the stroke of a pen wiped out the protections afforded our members of the Armed Services by clearing the way for DOD's mandatory mass inoculations," Blumenthal explained.

"The plain fact is that the AVA is still an investigational drug and should not be used without appropriate informed consent. I call upon the DOD and the FDA to cease and desist from their illegal conduct and to abandon plans for Anthrax Vaccine inoculation of the Armed Forces," said Blumenthal, urging that the DOD at least make inoculation voluntary. "Additionally, the FDA should block the manufacture and sale of AVA by Bioport and renounce the 1997 action which illegally cleared the way for the DOD's mass inoculations."

Blumenthal has worked on the Anthrax vaccine issue for more than a year. He was prompted to investigate the program by current and former Connecticut Air National Guard pilots, including Major Russell Dingle and Major Thomas Rempfer, who resigned the Guard in 1999 rather than receive the Anthrax vaccination.

To see a copy of the Attorney General's letter to the Department of Defense, link here
File name: dod.pdf
File size: 56KB

To see a copy of the Attorney General's letter to the Food and Drug Administration, link here
File name: fda.pdf
File size: 51KB

Found on the WWW at: http://www.cslib.org/attygenl/press/2001/health/dod1.htm

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Last revised: March 2001