by Elaine M. Grossman

Inside The Pentagon

March 2, 2000

Among the many facts obscured in months of debate about the Pentagon's controversial anthrax vaccination program is one that has life-or-death implications: a person has a nearly 100-percent chance of surviving exposure to anthrax if treated immediately with a 30-day course of antibiotics and vaccine.

This fact, substantiated by the Pentagon's own scientific research, stands in contrast to public assertions by a number of Defense Department officials that suggest exposure to anthrax spores is the equivalent of a death sentence.

"Death is the predictable outcome of inhalational anthrax in unvaccinated persons," stated Army Maj. Gen. G. Robert Claypool, then deputy assistant secretary of defense for health operations policy, in July 21, 1999, testimony before the House Government Reform national security subcommittee. "Once clinical symptoms appear, death is assured, despite the most heroic, state-of-the-art, post-exposure medical intervention and treatment given," said Claypool, who has since retired.

His statement included an important assumption, one that has escaped much notice. True, research suggests there is little chance of survival if a person waits until symptoms appear before receiving antibiotic therapy. But if an individual suspects exposure and immediately begins a drug regime, the odds of survival shoot up into the 90- to 100-percent range, depending on the medications administered.

Kathryn Zoon, the director of the Food and Drug Administration's Center for Biologics Evaluation and Research, told the same House subcommittee last April that "in the case of pulmonary anthrax infection, therapy has been of limited benefit, except when given immediately after exposure."

And there's the rub. Defense officials are not confident they can immediately detect any and all incidents of biological warfare involving anthrax, which the Pentagon says has been weaponized by 10 nations around the world. Seven of those countries are regarded as potential adversaries.

Biological detection devices capable of identifying an anthrax attack have been fielded throughout U.S. forces. But "it's kind of difficult to say [whether an attack would be detected] because it depends on the situation," said one defense official, interviewed Feb. 29 on condition of anonymity. The services do not have enough such devices to "cover every square inch of the battlefield," the official said, but there is enough detection capability to give service members reasonable confidence of detection in particular areas in which they would fight.

If an attack is imminent or has begun, service members will be instructed to immediately don protective gear, even if they have received the anthrax vaccine, the defense official said.

Perceived shortfalls in detection and protection capability have prompted the defense leadership to move forward with the mandatory program to vaccinate all soldiers, sailors, airmen and Marines by around 2005. To date, over 400,000 military personnel -- those anticipated to deploy to high-risk areas -- have received at least one shot in the six-injection regime, after which annual boosters are required.

The defense official said the hope is that if the military fails to detect an attack or if the protective gear falls short, those who have taken the vaccine will not fall ill. But even the vaccine is not assumed to provide 100-percent immunity to all those who take it, the official said.

Thus, Pentagon policy calls for even immunized personnel to receive antibiotics if they have been exposed to anthrax. In a policy issued in March 1998 that "applies to all forces regardless of their anthrax immunization status (i.e., immunized and non-immunized individuals)," then-Acting Assistant Secretary of Defense for Health Affairs Gary Christopherson stated, "Antibiotics taken after exposure to a large number of anthrax bacteria, such as would occur after a weaponized release, will probably result in greater protection than is afforded by the vaccine alone." The statement, which a Pentagon spokesman said this week remains current policy, adds that "post-exposure antibiotic therapy for anthrax-immunized individuals provides an additional measure of safety and in no way implies that the vaccine is not the preferred preventive measure."

The directive advises that ciprofloxacin is the preferred antibiotic treatment, with doxycycline being an "acceptable alternative." Both are common antibiotics.

In keeping with this policy, a briefing issued last December to DOD health care providers by the Pentagon's Anthrax Vaccine Immunization Program, notes that for personnel exposed to anthrax, "Antibiotics are still indicated even when [individuals are] fully immunized."

As a result, the Pentagon looks at detection devices, protective gear, and the vaccination program as having a "synergistic effect," together providing what leaders hope will be "better than 99-percent protection," the official said.

Even if anthrax exposure is suspected but has not been confirmed in a given incident, in theory, medical therapy could begin if there are enough antibiotics stockpiled, experts say. By press time this week, the Defense Department was unable to provide details regarding the extent of the antibiotics stockpile or how it would be used in a crisis.

On Dec. 14, Jay Davis, the director of the Defense Threat Reduction Agency, told reporters the Pentagon has an ample enough supply of antibiotics to treat anthrax victims, assuming a Desert Storm-sized call-up. He added there is enough protective gear for a second major regional conflict as well, if needed, but "I don't know about the antibiotics" (Inside the Pentagon, Dec. 16, 1999, p2).

Confidence that antibiotics, combined with post-exposure anthrax vaccines, can allow an individual to survive an otherwise fatal illness is based largely on research performed between September 1990 and February 1991 by the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) in Frederick, MD.

Under the so-called "challenge" tests, unvaccinated rhesus monkeys were exposed to a fatal dose of anthrax in aerosol form -- the way in which an adversary's weapon may distribute the disease. A test group of 10 monkeys that received doxycycline, beginning within a day of exposure and continuing for 30 days, had a 90-percent survival rate. Those treated with penicillin and ciprofloxacin did less well, with survival rates of 70 percent and 89 percent, respectively.

A Pentagon spokesman this week was unable to explain why DOD policy is to administer ciprofloxacin, with doxycycline used only as a back-up alternative.

In the test's most striking results, all nine monkeys in a test group survived when treated with a combination of two vaccines -- at the first and 14th day after infection -- and the 30-day doxycycline regime.

Those treated solely with the post-exposure vaccine, but without antibiotics, faired rather poorly. Eight of 10 animals died relatively quickly under that regimen.

Similarly, nine of 10 monkeys died who were exposed to anthrax but received neither the vaccine nor any antibiotic. The one that survived "never had a positive blood culture" for anthrax, despite having breathed the spores, according to the research article on the tests, published in The Journal of Infectious Diseases in May 1993. Last week, a Pentagon spokesman said in response to questions from ITP that "in the case of anthrax, therapeutics must include vaccination since antibiotics alone will not work." Critics point out, though, that in the face of a disease as potentially lethal as anthrax, providing 90 percent or so survival rate using solely antibiotics -- if necessary -- is not bad, considering some of the alternatives.

The research article, whose lead author was Col. Arthur Friedlander, USAMRIID's senior military scientist, said the monkey research "results suggest that therapy for an unimmunized person exposed to an aerosol of anthrax spores should consist of long-term suppressive antibiotics. Vaccination may provide an additional degree of protection against relapse after antibiotic treatment and would protect against a subsequent exposure."

If an unvaccinated service member is exposed to aerosolized anthrax and remains untreated afterward, the "spores cause respiratory failure, leading to death within a week," according to information the Defense Department has posted to its Internet site (www.anthrax.osd.mil). With an incubation period of between one to six days, it is risky to begin treatment only after symptoms have appeared, DOD states.

"After serious symptoms have occurred in unvaccinated people, despite intensive care treatment and antibiotics, death rates still exceed 80 percent," according to the web site, which does not cite the scientific basis for these figures. Without any treatment the disease kills 99 percent of unvaccinated, unprotected people. "Therefore," it adds, "antibiotic treatment must be started at the earliest sign of disease."

The Defense Department -- promoting its massive vaccination program -- makes the point that with anthrax spores being odorless, colorless, and tasteless, it may be difficult to know an individual has been exposed until symptoms begin.

The defense official interviewed this week said the "worst-case scenario" for anthrax is one in which an adversary spreads aerosolized anthrax spores using an aircraft like a crop duster, which could affect a great number of people.

On the other hand, such an incident is unlikely to go unnoticed, especially if it occurs in the direct vicinity of U.S. forces. The defense official said there is some solace in the air superiority the Air Force and Navy have been able to provide in recent contingency operations, in which no enemy aircraft activity goes undetected and the little that remains is ultimately shut down.

Other scenarios would have an enemy spreading anthrax in a more clandestine manner, which could be much harder to detect. Attacks such as these might be carried out by special forces, for example, with an eye toward contaminating a water supply with anthrax or another biological agent.

The Defense Department currently fields a variety of detection systems:

* The Army has a reserve company and an active-duty company each outfitted with 38 mobile Biological Integrated Detection Systems (BIDS), which provide in-theater detection and warning, according to the Pentagon spokesman's written responses to questions. Each company could deploy with an Army unit of corps size or greater, or part of a company could deploy with a smaller element of soldiers.

* The Navy has 20 Interim Biological Agent Detectors installed on vessels operating in littoral waters, the spokesman said. Fifteen of these are shipboard systems, while the remaining five are available for contingency operations.

* The services also employ Portal Shield Air Base/Port Detector Systems, which integrate point detection systems into headquarters for warning and detection of attack. Four such networks are operating in Korea and Southwest Asia, and five more are to become operational in fiscal year 2000, the Pentagon spokesman said.

* On the level of the individual soldier, a number of hand-held assays are available that can identify biological agents such as anthrax.

Last year, "the Joint Staff identified a shortfall in biological detection [capability] and requested that we establish an additional active component BIDS company," the DOD spokesman stated. This new unit will be available for rotation to high-threat theaters beginning in fiscal year 2002, according to the spokesman. The air base and port detection systems will also be installed at another 14 sites in the Pacific and Central Command theaters between FY-01 and FY-02.

Research and development continues on future detection systems as well, including the Joint Biological Point Detection System, a follow-on for BIDS, the defense official said in this week's interview. Additional technologies for an individual soldier's use will be fielded at the company level by about 2003, the official said.

Beyond that, the U.S. military aims to field a "detect to warn" capability. Currently, the military can boast only a "detect to treat" capability, the official explained.

Future systems may be able to detect the presence of biological agents, possibly using lasers aboard helicopters, out to 50 kilometers, according to this official.

The Pentagon spokesman said last week that quick analysis at medical laboratories is another key component of detection. "Only when a confirmatory sample is taken and evaluated can medical intervention be made," the spokesman said. "Medical diagnostic systems are also in development to automate and speed laboratory work to confirm a biological attack."