Friday, June 15, 2007

Congress demanded detailed research on anthrax vaccine in 1999

The Congressional Record (HR Rep. No. 106-371 at 254-55) shows that on October 8, 1999 it stated, "The Department[of Defense] is directed to enter into a contract with the National Research Council to independently study the effectiveness and safety of the anthrax vaccine. The following issues shall be considered in the report: the types and severity of adverse reactions, including gender differences; long-term health implications; inhalational efficacy of the vaccine against all known anthrax strains; correlation of animal models to safety and effectiveness in humans; validation of the manufacturing process focusing on, but not limited to discrepancies identified by the Food and Drug Administration in February 1998; definition of vaccine components in terms of the protective antigen and other bacterial products and constituents; identification of gaps in the existing research."

Although the Institute of Medicine Committee did offer opinions as to the vaccine's safety and effectiveness in its 2002 report, its opinions did not reflect the existing literature on efficacy--which makes clear that efficacy is uncertain for inhaled, weaponized anthrax. Its opinions on safety are contradictory. All the questions Congress posed in 1999 have yet to be resolved, with the exception that gender differences are real and women sustain 2-3 times more adverse systemic reactions than men.