Guinea Pigs on Capitol Hill?
Dave Eberhart, NewsMax
Tuesday, Mar. 4, 2003
Some staffers on Capitol Hill are voluntarily participating in a U.S. Army clinical trial of the controversial BioPort anthrax vaccine, but ads to recruit the study subjects recently placed in The Hill and Roll Call publications have stirred some controversy of their own.
One such advertisement, titled “Volunteers Needed: For a Clinical Trial of Licensed Anthrax Vaccine,” was placed by the Clinical Trials Center of the Walter Reed Army Institute of Research. The advertisement states that the “purpose is to see if using fewer shots given in the muscle will give a good immune response with fewer side effects.”
The advertisement is similar to one placed by the Army in the Washington Post on October 15, 1996, Steve Robinson, Executive Director the National Gulf War Research Center, tells NewsMax. “The Army’s use of ‘licensed’ in the text of that [1996] ad infers ‘safe and effective’ – as it does again in the recruiting ad for the Hill staffers.”
Robinson points to a December 13, 1996 letter from the Federal Pure Food and Drug Administration to the Army as being again on target:
“The anthrax vaccine is approved for the indication of the labeling specified in the vaccine, but not for the indication currently under investigation... No claims should be made, either explicitly or implicitly, that the drug, biologic or device is safe or effective for the purposes under investigation…”
Robinson says the Army is -- in the case of the Hill study -- once again inferring that the BioPort anthrax vaccine is licensed for the purposes for which it is under clinical investigation. “In fact,” says Robinson, “the proposed reduction in doses and intramuscular administration of the vaccine were two of the objectives of a September 20, 1996 Investigational New Drug application that remains active today. Therefore, the vaccine remains investigational -- not licensed -- for the purposes of the Army’s advertisement.”
Embattled History
The latest installment in the long embattled history of the vaccine reopens lingering questions.
The Department of Defense has court-martialed, demoted, fined, and given discharges to servicemembers who have refused the anthrax vaccine. In an ironic note, however, in May 2002, the Department of Veterans Affairs recognized the unique risks posed by the vaccine. That agency’s general counsel issued a legal finding -- solely for the anthrax vaccine -- that redefined and broadened the meaning of the word “injury” with respect to disabilities caused by the vaccine.
No other vaccine used by the military has been so recognized.
The chronic illnesses that were the catalyst for the VA’s legal finding are documented in the anthrax vaccine package insert and include deaths, birth defects, and chronic autoimmune disorders such as Lupus, multiple sclerosis, Lou Gehrig’s disease (ALS), chronic fatigue syndrome and other ailments that mirror Gulf War Illness.
Says Robinson, who has sent a formal complaint to Dr. Mark B. McClellan, the Commissioner of the FDA: “Absent FDA intervention, it is unclear whether the Army and BioPort will provide information on chronic illnesses to Congressional staffers and other civilians who are recruited for their current clinical trial.”
Robinson adds, “The Army’s targeting of Congressional staffers by advertising at ground-zero of the anthrax attacks may represent a violation of the prohibition on coercive recruiting of clinical trial participants.”
When 10,000 Congressional staffers and postal workers were offered the vaccine -- with informed consent after being advised of the potential side effects -- only two percent of them accepted.
Federal law allows the DoD to use experimental or investigational drugs or vaccines on servicemembers, without informed consent, as long as the President signs a waiver of informed consent. To date there has not been a Presidential waiver of informed consent for the mandatory use of the experimental BioPort anthrax vaccine.
Read more on this subject in related Hot Topics:
Bioterrorism
Health Issues
Homeland/Civil Defense
Editor's note:
World’s leading bio-weapons experts warns of smallpox catastrophe – Click here now