Mark S. Zaid, Esq.
(202) 785-3801

The James Madison Project Files FDA Petition to Modify Anthrax Vaccine Product

Petition Seeks to Raise Systemic Reaction Rate from0.2% To 5%-35% and Recognize Gender Differences


The James Madison Project (JMP) has filed a citizen's petition with the Food & Drug Administration (FDA) to modify the product insert of the Anthrax Adsorbed Vaccine to accurately reflect the true systemic reaction rate and acknowledge gender differences. The anthrax vaccine, which was originally licensed by the FDA in 1970, presently states the systemic adverse reaction rate is a mere 0.2%. Documents obtained through civil litigation, military court-martials and congressional hearings have, however, revealed a reaction rate up to 175 times greater than the Department of Defense (DoD) was willing to admit.

After more than a year of intense controversy, the DoD has now publicly conceded that the true systemic adverse reaction rate is between 5%-35%, and that women may experience reactions rates twice that of men. A systemic reaction, in reference to an injectable edication, is a reaction that occurs away from the site of injection. Acknowledged reactions now include joint aches, headaches, malaise, rashes, chills, low-grade fever, nausea, or related symptoms. The petition requires the FDA to determine within six months whether it will modify the vaccine's product insert. Litigation can be commenced to force FDA action should it deny the petition or fail to take action within the statutory period.

"The DoD has repeatedly misled the public concerning information surrounding the anthrax vaccine. Internal military studies revealed a significantly higher reaction rate to the vaccine, but the DoD did its best to hide this information for as long as it good. The petition forces the FDA to now recognize what the DoD has known for years," said Mark S. Zaid, JMP's Executive Director. Zaid, who has also served as the senior defense counsel in nearly one dozen court-martials of servicemembers who have refused the vaccine, added that this information is critical to the many dedicated servicemembers who have suffered from ill-effects from the vaccine so that proper treatment can be administered.

Documents obtained through the Freedom of Information Act in 1998 first revealed the DoD's knowledge that systemic adverse reaction rates were up to seven times greater than the figures it had repeatedly publicly pronounced. Dozens, if not hundreds, of servicemembers were misinformed that reactions they were suffering following inoculation were not the result of the anthrax vaccine. DoD claimed reaction rates were as low as .0002%, a percentage that was scientifically manipulated. Testimony delivered before Congress by the General Accounting Office on April 29, 1999 and July 21, 1999 further revealed that, in fact, the true adverse reaction rates were up to seventy times greater than DoD admitted, and that women suffered ill effects twice as much as men.

In a letter dated December 10, 1999 from Lieutenant General Ronald R. Blanck, the Army's Surgeon General and the leading medical official implementing the anthrax vaccine program, to JMP's Executive Director Mark Zaid, the DoD admitted that [s]ystemic events occur in five to 35 percent of anthrax-vaccine recipients. Brochures disseminated to military servicemembers that once claimed the systemic reaction rate was less than 1% now have been revised to reflect the true figure of 5% to 35%; an acknowledgment that reactions can be as much as 175 times greater than the FDA approved in 1970.

"The FDA has been suspiciously silent during the anthrax vaccine controversy having generally chosen not to publicly challenge the DoD's vaccine program. It is time that federal drug regulators intervene in this matter," said Zaid. The petition argues that the "FDA also has an obligation to protect those who receive the anthrax vaccine. Given that the present product insert label for the anthrax vaccine does not reflect accurate information concerning systemic adverse reactions, it is the FDA's responsibility to ensure that it does."

The Defense Department is forcibly inoculating all 2.5 million active duty personnel, regardless of duty station or responsibilities, against anthrax at an estimated cost of $130 million. The immunization series calls for six injections of the vaccine over a period of 18 months, followed by annual booster shots. Vaccinations began in March 1998, but in December 1999 it was announced that Phase II and III of the program would be delayed for at least one year due to the continuing existence of FDA violations at the vaccine's manufacturing plant. Approximately 300-500 active-duty service-members have refused the vaccine, and at least 40 have been court-martialed. Additionally, around 500 pilots and flight crew members have quit or resigned from the Air National Guard or Reserves rather than take the vaccine, thereby jeopardizing the United States' capabilities to conduct future air campaigns.

JMP is a Washington, D.C.-based non-profit organization with the primary purpose of educating the public on issues relating to intelligence gathering and operations, secrecy policies, national security and government wrongdoing.

A copy of the petition will soon be available at JMP's official Website at