Although the Pentagon has long maintained that its controversial anthrax vaccine is licensed for use against aerosol exposure from biological weapons, military leaders now are asking to amend the license for such use.
Opponents of the program say that it proves what they’ve argued all along: vaccinating troops against possible exposure to anthrax weapons is a violation of the existing license and requires treating the vaccine as an experimental drug.
And that could mean that troops could not be given the vaccine against their will, only with informed consent, which a congressional panel recommended last month and the Pentagon flatly rejected.
Last week, the Department of Defense released its annual report on its chemical and biological defense program. Deep in an appendix of the 272-page document is a description of accomplishments in 1999 by the Joint Program Office for Biological Defense, the agency that manages the Pentagon’s biological warfare vaccination programs.
Among other items, it states that the office “managed and funded efforts leading to the submission of a Biologic Licensure Application amendment to the FDA,” including data to support its proposal “to license the vaccine to provide protection against aerosol exposure to anthrax.”
Attempts to get an answer as to why such a license amendment is being requested despite previous statements by military leaders that it was not necessary were fruitless.
The Joint Program Office and other defense agencies eventually directed the question to Army Public Affairs. The Army owns the anthrax vaccine program. An Army spokesman called it “a very, very good question” but could not get an answer last week.
But critics of the program said the license application, which has never been revealed in congressional testimony or other public statements, shows that the Pentagon has not been telling the full truth about the vaccine.
“It seems to me that somebody in DoD is being misleading in their public statements,” said George Robertson, who once ran a civilian lab at Fort Detrick, Md., that conducted research on an improved anthrax vaccine. He is now a senior executive with a biological research firm.
“The DoD clinical development people are saying one thing: that they need to submit data to the FDA to demonstrate that this vaccine is effective against inhalation anthrax and to change the label to reflect this new indication.
“Yet the public affairs people at DoD take the position that the FDA has already approved this. It is disappointing how the public relations side of DoD doesn’t talk to the professional biomedical side.”
Col. Redmond Handy, who retired from the Air Force Reserve in protest of the anthrax vaccine and co-founded the National Organization of Americans Battling Unnecessary Servicemember Endangerment (NO ABUSE), said that the Pentagon’s plan to protect troops from aerosol biological weapons is “a completely different indication and use of the vaccine” from its original license.
“No one knows whether the vaccine will do that job,” he said.
Anthrax is a livestock disease that the Pentagon believes would be one of the most likely diseases used as a biological weapon. Iraq and North Korea are both believed to have active anthrax weapons programs, as are other countries.
In December 1997, the Pentagon announced that every active duty, reserve and National Guard member — 2.4 million soldiers, sailors, airmen and Marines — would be vaccinated against anthrax over the next several years.
Almost immediately, troops and activists began opposing the vaccination, arguing it was neither safe nor likely to be effective against inhalation anthrax.
Several hundred service members have refused the shot and received punishments ranging from simple discharge up to trial by court martial.
Activists say hundreds of reserve and Air Guard pilots have resigned or transferred to other units to avoid the vaccine. The Pentagon says it can’t confirm those numbers because it doesn’t track such refusers.
The 1970 license for the vaccine was based on a study of how well it protected against the cutaneous, or skin exposure form, of the disease among workers in wool mills.
But an enemy who used anthrax as a biological weapon would likely release it as an aerosol cloud or spray in an attempt to cause the highly lethal inhalation form of the disease.
Military leaders say unpublished animal studies have shown the vaccine protects against inhalation anthrax and that it would be unethical to conduct experiments on humans.
And they cite FDA statements that vaccination against biological weapons is “not inconsistent” with the license.
Opponents of the vaccination program say the revelation that the Defense Department is asking to amend the license shows how weak the military’s argument for the vaccine actually is.
“It may well be that DoD is attempting to avert any possible legal challenges arising from use of the vaccine or its potential ineffectiveness against aerosolized anthrax,” said Mark Zaid, an attorney who has represented several vaccine refusers.
Originally Published, March 27, 2000 , Belleville News Democrat,
(c) 2000, Belleville News-Democrat, Belleville, Ill.
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