Army Times Publishing Co. Pentagon Newspaper, The Early Bird
Stars and Stripes Omnimedia
May 15, 2001
By Dave Eberhart, Stars and Stripes News Editor
(Stars and Stripes Omnimedia is a privately owned news source and is in no way affiliated with the U.S. government.)
Lawyers for Air Force Capt. John E. Buck, the first doctor to be court-martialed for refusing the anthrax vaccine, today cracked open a Pandora's Box that government attorneys have labored hard to keep shut.
It was the second day of pre-trial hearings at Keesler Air Force Base, Miss., where Buck is being court-martialed for disobeying an order to take the anthrax vaccine. A Department of Defense e-mail was one of several documents entered into evidence.
"I will work the BioPort [anthrax vaccine manufacturer] oversight plan, but believe we are digging ourselves a hole that will be too difficult to crawl out..." said Brig. Gen. Eddie Cain, former director of the Joint Program Office for Biological Defense, in an e-mail uncovered by Dr. Buck's defense team.
The Cain e-mail was a May 3, 1999 communication in which Cain acknowledged that the General Accounting Office's (GAO) Dr. Kwai Chan had raised two important issues in testimony before the House Government Reform Committee that could mean "big time trouble" for the DoD and the administration.
According to committee records, Chan, a GAO investigator who is scheduled as a defense witness, told the panel in 1999 that the vaccine used in the military's mandatory inoculation program was different from that used in the Pentagon's own studies of the anthrax vaccine's effectiveness. Buck's defense team obtained the records and e-mail from the office of Rep. Christopher Shays, R-Conn., chair of the Subcommittee on National Security, Veterans Affairs, and International Relations of the Government Reform Committee.
Chan, rebutting the DoD's assertion that there is no causal relationship between Gulf War Illness and the anthrax vaccine, testified that the DoD did not mark the shot records of personnel receiving the vaccine.
Cain voiced concern in his e-mail to a subordinate that DoD could not do a good job refuting the GAO contention on Gulf War illness and its assertation that the anthrax vaccine licensed was different from the vaccine tested. Cain said in his e-mail that the DoD was "digging ourselves a hole" in its relationship with the BioPort Inc., of Lansing, Mich., the sole manufacturer of the vaccine. He admitted to the "DoD calling the shots onsight [sic]," and worried what would happen when Shays "finds out."
"Gen. Cain's fears were well-grounded," Shays told The Stars and Stripes today. "It is still 'big time trouble' that a different anthrax vaccine was tested against a different route of exposure, and that vaccine safety was not monitored."
Shays: 'Profound Questions'
"As our Government Reform Committee oversight report concluded last year, the vaccine should be considered investigational when used for biological warfare defense," Shays said.
"Buck's refusal to take or use the vaccine 'off label'--for the unapproved purpose of biological warfare defense--raises profound legal and ethical questions about the anthrax program," he said. "No allegedly lawful military order should require a doctor to violate his Hippocratic oath.
"As the program heads toward almost certain collapse, we have even more reason to be critical of DoD and FDA for coddling the vaccine maker, BioPort," Shays said. "We've known for some time DoD was propping up a company and a vaccine that would otherwise never survive scrutiny by the FDA or the commercial marketplace.
"It's long past time to give up this futile effort to drag a 1950's medical technology into the 21st century. No one else's health should be put at risk, and no more military careers should be destroyed on the altar of this unquestionably failed vaccine program."
Over prosecution objections, lead defense attorney Frank Spinner was permitted to question Dr. Meryl Nass, a recognized authority on the military use of anthrax vaccine, concerning Pentagon documents subpoenaed in 1999 by Shays, during House Government Reform Committee hearings about the safety of the anthrax vaccine.
Nass said that the vaccine, licensed in 1970, was only tested on animals and that clinical studies on humans, as required by the Food and Drug Administration, were never conducted.
The defense team argues that testimony like Nass's is vital to allow Buck a chance to overcome the presumption that the order he is accused of disobeying was legal. The defense wants to be in a position to present evidence on the vaccine's safety to the jury, which has not yet been sworn in.
One defense document, dated May 16, 1985, from the U.S. Army Medical Research Acquisition Authority, Fort Detrick, Md., said, "There is no vaccine in current use which will safely and effectively protect military personnel against exposure to this hazardous bacterial agent."
An Oct. 5, 1995, memo, headed "Plan to Revise Anthrax Vaccine Immunization Schedule," from the director of the a medical biological defense research program said, "This vaccine is not licensed for aerosol exposure expected in a biological warfare environment."
Spinner also submitted a request for information from the FDA on the vaccine in Lot 044--the vaccine that would have been used in Buck's inoculation--which was subject to an FDA recall last year.
The government attorneys referred to a FDA finding that the product insert label for the anthrax vaccine does not limit its use to a particular route of bacterial exposure so long as the schedule of doses is followed.
DoD: Order was Lawful
"There can be no question that the [Buck's] squadron commander was properly executing DoD policy when he directed the accused to obtain the anthrax vaccine," said prosecutor Maj. Scott J. Wilkov. So the defense's challenge "is not so much to the order, as it is to the Department of Defense's Anthrax Vaccine Immunization Program."
"There may be some risk inherent in many military orders, but they are all valid as long they serve a legitimate military objective," Wilkov said. "Otherwise, there would be no aircraft flights over enemy territory. Nor would the Army be able to boast of their paratroopers.
"That the individuals expected to follow such orders might he subject personal injury does not detract from the lawfulness of the commands they are issued," he argued, and the anthrax vaccination program can't be invalidated "even if it is not one hundred percent effective and carries with it some side effects."
Buck and former Air Force Maj. Sonnie Bates filed suit in U.S. District Court for the District of Columbia May 3 asking that the vaccine be declared an experimental drug and thus prohibited without servicemembers' informed consent.
Named as defendants in the suit are Defense Secretary Donald Rumsfeld, Health and Human Services Secretary Tommy Thompson, and Bernard A. Schwetz, the FDA's acting principal deputy commissioner. Also named is BioPort, Inc.
"The substantive changes in the way the vaccine is used and the purpose for which it is used render the vaccine an IND [investigational new drug] under current federal law," said Buck's attorney John J. Michels Jr. "As an IND, the vaccine may not be administered to service members without their informed consent. It is patently illegal."
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