http://thomas.loc.gov/cgi-bin/bdquery/z?d107:HR03448:@@@L&summ2=m&

Comments on HR3448 by Major Thomas "Buzz" L. Rempfer

H.R.3448 -- Title: "To improve the ability of the United States to prevent, prepare for, and respond to bioterrorism and other public health emergencies." ... "Title III: Subtitle B: (Sec. 406) Requires the issuance of a final rule concerning the use of animal trials in the approval of priority countermeasures."

Dear Concerned Citizens and Soldiers,

The issue is simple. Part of this legislation allows animal efficacy data to replace the current legal requirement for human clinical trial efficacy data for the licensing of vaccines for priority countermeasures. Both the new product label for the current anthrax vaccine, the recent IOM (Institute of Medicine) report, and the historical correspondence and government records confirm that the current licensed anthrax vaccine's efficacy against inhalation anthrax infection is based on such animal data.

This bill confirms animal data currently doesn't comply with the requirements of the law for full licensure. DoD was party to sponsoring this pending change in the law as documented in their 2001 report to Congress on the issue. Essentially, DoD has willfully circumvented current law. The application they formulated for the anthrax vaccine to be approved for inhalational anthrax in September 1996 was not approved by the FDA. They launched the program anyway in 1997, inoculated over 525,000 military members for this acknowledged experimental application of the anthrax vaccine, and subsequently sponsored a change to the law that should have required a Presidential waiver of informed consent for a mass mandatory program for either an off regimen inoculation series or use against inhalational anthrax, both which are experimental.

The question all citizens should ponder is whether or not it is appropriate for our armed forces leadership to violate the law, and then sponsor changes to the laws that became a hindrance to the accomplishment of their military objectives. At this point it appears they have been successful, but the questions remain as to whether or not this process is healthy for or legal within a democracy?

Respectfully,

"Buzz"

Major Thomas L. Rempfer

PS. More info available:

A declaratory judgment act suit was filed and is pending relevant to this issue:

http://www.majorbates.com/law/03may01_dj_lawsuit.htm

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