The Anthrax Shots: Should They Continue?

Too Many Unanswered Questions

By Patrick G. Eddington

Army Times

July 31, 2000

A number of questions were left unasked at the July 12 Senate Armed Services Committee hearing into the Pentagon's anthrax vaccine immunization program. For example, does the Food and Drug Administration have one regulatory standard for civilian medicine and another, less stringent, standard for the military?

Consider this: Earlier this year, the FDA banned the rotovirus vaccine after 20 reports of severe adverse reactions in infants. But as Kathryn C. Zoon, director of the FDA's Center for Biologic Evaluation and Research, told senators the anthrax vaccine is safe, she acknowledged 74 "life-threatening" reactions had been documented in the military program.

Critics would argue that this is just the latest example of the FDA's willingness to kowtow to the Defense Department - even if it means putting service members' health at risk.

Before Desert Storm, Pentagon planners insisted that troops take the drug pyridostigmine bromide as a nerve-agent prophylactic - despite a considerable body of scientific evidence that suggested healthy individuals who took PB might suffer severe, irreparable neurological damage. Despite the risks, the FDA granted the Pentagon a waiver to use PB on an "investigational basis" to protect U.S. troops from Saddam's chemical arsenal. In 1998 testimony before the Senate Veterans' Affairs Committee, the Pentagon's point man on Gulf War illnesses, Bernard Rostker, conceded that this was "a mistake." PB is suspected as a possible cause of the neurological disorders afflicting Gulf War veterans. In 1997, the Pentagon initiated the Joint Vaccine Acquisition Program, which includes a 10-year contract with DynPort LLC for the development of vaccines against the acute infectious diseases Q fever and tularemia, and the contagious disease vaccinia. Dr. Michael Gilbreath, chief scientist with the Joint Program Office for Biological Defense, said DynPort may be called upon to develop vaccines against other biological-warfare threats, such as ricin, plague, staphylococcal enterotoxin B. and Venezuelan equine encephalitis. All of this raises another question not asked at the Senate hearing: How can we know for sure these proposed vaccines match up against the alleged biological warfare threat?

Prior to the Gulf War, American intelligence agencies believed Iraq had weaponized both anthrax and botulinum toxoid. Post-war United Nations inspections verified the estimate. Only in 1995 did the world learn that Iraq also had weaponized aflatoxin, an obscure but potentially deadly plant fungus. Had Saddam's late son-in-law Hussein Kamal not defected to Jordan and revealed it, Iraq's aflatoxin program would have remained hidden - despite the most intrusive arms-control inspection effort in history.

Contrary to Pentagon claims that the vaccine acquisition and immunization programs are based on "threat assessments," the reality is that U.S. intelligence agencies almost never can provide a truly accurate picture of a potential opponent's biological-warfare capabilities. Instead of using such intelligence gaps to justify multi-million-dollar vaccine programs that may compromise the health of service members, Pentagon planners need to get back to the basics.

First, the Defense Department must field chemical-biological detection systems and protective masks and suits that work. The Pentagon has for years failed to procure reliable, real-time detection equipment, functional masks and reliable chemical-biological protective suits. Had Saddam's forces used aflatoxin during the Gulf War, the attack would have gone undetected until the onset of symptoms. Second, the Pentagon should abandon its self-defeating reliance on vaccine-based defense. Given the dozens of microorganisms available to rogue states, it is scientifically and fiscally impossible for the government to engineer vaccines against all such threats.

Military planners should emphasize rapid detection, decontamination and post-exposure antibiotic treatment in the event of a confirmed attack. Finally, Congress must end the FDA's double standards for civilian and military medicine. Lawmakers must ensure the FDA applies the same testing, monitoring and enforcement standards for drugs and biologics used by the military that it applies to the civilian market.

Anything less reduces American military volunteers to the status of involuntary guinea pigs.

(Former CIA analyst Patrick G. Eddington is senior research analyst at the James Madison Project, a Washington, D.C., nonprofit organization specializing in First Amendment and national security issues.)