Contrasting statements and studies --- Dr. vs. the IOM report

[Guest guest]

Statement by Dr. Sue , Assistant Secretary of Defense for Health Affairs

Submitted to Subcommittee on National Security, Veterans Affairs and

International Relations Committee on Government Reform, U.S. House of

Representatives

March 24, 1999, Full testimony available at:

<A HREF= " http://www.house.gov/reform/ns/hearings/baileytest324.htm " >http://www

..house.gov/reform/ns/hearings/baileytest324.htm</A>

" The Department is confident, as is the Food and Drug Administration (FDA),

that the FDA-licensed anthrax vaccine is safe and efficacious for its

intended use of immunizing the total force against anthrax. The anthrax

vaccine has been licensed by the FDA since 1970 and has been recommended for

veterinarians, laboratory workers, and livestock handlers in the US for more

than 25 years. There have been no long-term side effects reported with the

FDA-licensed anthrax vaccine. "

" The safety of our AVIP was also confirmed by an independent review of the

program. Dr. Gerard N. Burrow, who serves as Special Advisor for Health

Affairs for the President of Yale University, conducted the review. Dr.

Burrow concluded that 'the anthrax vaccine appears to be safe and offers the

best available protection against wild-type anthrax as a BW agent.' "

(Note: This is the same gentleman who confirmed he had no expertise in

anthrax and did this review out of patriotism with the DoD's help.)

Note: Please contrast these comments to the latest report by the DoD

contracted study, mandated by the Congress, and performed by the Institute of

Medicine (IOM), affiliated with the National Academy of Sciences.

------------------------------------------

Full report available on line at:

<A HREF= " http://www.nap.edu/html/anthrax_vaccine/ " >

http://www.nap.edu/html/anthrax_vaccine/</A>

Conclusions on Human Studies

There is a paucity of published peer-reviewed literature on the safety of the

anthrax vaccine. The committee located only one randomized peer-reviewed

study of the type of anthrax vaccine used in the United States (Brachman et

al., 1962). However, the formulation of the vaccine used in that study

differs from the vaccine currently in use. The series of Ft. Detrick studies

shows no clinical sequelae from multiple vaccinations, including the anthrax

vaccination, over 25 years of intermittent observation in a highly selected

cohort. However, there was no active surveillance for chronic symptoms in

these studies, which raises the possibility of underreporting of symptoms.

The published studies have found transient local and systemic effects

(primarily erythema, edema, or induration) of the anthrax vaccine. There have

been no studies of the anthrax vaccine in which the long-term health outcomes

have been systematically evaluated with active surveillance. That is not

unusual, however, as few vaccines for any disease have been actively

monitored for adverse effects over long periods of time. The committee

strongly encourages the development of active monitoring studies that

evaluate long-term safety in recipients of the anthrax vaccine.

The committee concludes that in the peer-reviewed literature there is

inadequate/ insufficient evidence to determine whether an association does or

does not exist between anthrax vaccination and long-term adverse health

outcomes. This finding means that the evidence reviewed by the committee is

of insufficient quality, consistency, or statistical power to permit a

conclusion regarding the presence or absence of an association between the

vaccine and a health outcome in humans.