May 16, 2001

Expert: Anthrax Vaccine Not Proven

By Cain Burdeau
Associated Press Writer

BILOXI - An expert testified Tuesday in an Air Force court-martial proceeding that an anthrax vaccine used by the military was never properly tested or licensed.

Dr. Meryl Nass of Freeport, Maine, a member of several hospital boards who has conducted studies on the effects of anthrax on humans, testified in proceedings at Keesler Air Force Base for Capt. John Buck.

Buck, a 32-year-old emergency room physician, is accused of disobeying an order to take the vaccine before deployment to the Middle East last October.

In the pretrial session, Buck is asking Lt. Col. Mark Allred, the presiding judge, to dismiss the charge. Buck contends the order was unlawful because it's an experimental drug requiring a soldier's consent before it can be administered.

Allred may rule on this key aspect of the case today. Depending on his findings, he may dismiss the charge or rule that the order was lawful. Allred could also leave it up to a military jury to decide if the order was lawful.

Testimony on Tuesday centered on Nass, the sole witness to appear so far.

Nass said the vaccine used in government programs was only thoroughly tested on animals. She said there was no data to show whether the drug was effective and safe for humans.

The military insists the vaccine is the best weapon against biological attacks. Pressure mounted to immunize soldiers to biological agents in the wake of the Gulf War.

"This is for the critical health and protection of our troops. It's considered our first line of defense against anthrax biological warfare," Capt. Jim Winner, a spokesman for the prosecution, said.

Frank Spinner, a retired Air Force lieutenant colonel and lead defense lawyer, said he had documents to show the government was aware of problems with the vaccine and had attempted to develop a different form to meet federal requirements.

Questions have been raised about whether the anthrax vaccine licensed in 1970 ever met federal Food and Drug Administration standards. Nass said that was because there were no clinical studies done on humans as required by

"I think they've made it very clear that mass inoculation with this vaccine is not recommended," Nass said regarding an FDA document.

"I don't hold that there is some grand conspiracy on the part of the Department of Defense," Spinner said.

"But sometimes the word on the street doesn't reach up," he added. "I also know that generals don't always listen."

However, Belinda Bazinet, a Keesler Base spokeswoman, said several independent panels have reviewed the vaccine and found it safe and efficient.

Anthrax is a disease that typically afflicts animals, especially sheep and cattle. Dry anthrax spores, which can be put into weapons, can cause death in humans if inhaled.

Buck, a Pascagoula native, is a key figure in the resistance to the mandatory anthrax program. The program was started in 1998 out of fear of biological warfare against American diplomats and soldiers.

The resistance and allegations against the program have prompted legislators to review it.

On Tuesday, Rep. Christopher Shays, R-Conn., issued a statement in support of Buck, saying, "No allegedly lawful military order should require a doctor to violate his Hippocratic oath."

During later testimony Tuesday, Nass said there was an absence of data to show the anthrax vaccine does not cause cancer or fetal harm.

She said up to 100 women had contacted her about possible side affects from the inoculation, including birth defects.

Military lawyers, who had challenged Nass' qualifications as an expert witness, planned to question her later in the proceedings. They said Tuesday no decision had been made on whether they would call their own witness.

May 15, 2001

DoD Anthrax Documents And E-Mails Bolster Buck's Unlawful Order Defense

Army Times Publishing Co. Pentagon Newspaper, The Early Bird
Stars and Stripes Omnimedia
By Dave Eberhart, Stars and Stripes News Editor

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."

'Not Licensed'

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."