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he . Tue Wasnincton Posr ALL INFORMATICN Co HEREIN TS UNCLASST FIED Challenged Army Disputes Expert Who - Reviewed Vaccine Tests _By Tuomas E. Ricks Washington. Post Staff Writer The controversial anthrax vaccine that the Penta- gon is trying to inject into 2.4 million troops does not provide complete immunity to an anthrax at- tack, according to an outside expert who has exam- ined Defense Department records of laboratory tésis. Saldiers who are exposed to anthrax may become quite sick and be incapacitated for up to two weeks, even if they have received the full set of six in- oculalions, said George A. Robertson, a molecular biologist specializing in pharmaceuticals. But officials at the Army’s Medical Research In- stitute of Infectious Diseases at Fort Detrick, near Frederick, disagreed with Robertson’s interpreta- tion of the data. They said he was exaggerating the extent of iliness in monkeys that were vaccinated and then exposed to anthrax under laboratory con- ditions. The dispute over the degree of immunity con- ferred hy the anthrax vaccine is just the latest in a heap of problems encountered by the 24-year-old in- oculation program. Last week, the Pentagon announced that a loom- ing shortage of the vaccine will force the military to cut the number of doses it administers from 75,000 to 14,000 a month. Blaming production problems at the sole maker of the vaccine, Bioport Corp. of Lan- sing, Mich., the Defense Department said that for the reniairider of the year it will give up trying to vac- cinate all troops and focus on those serving in Korea and the Persian Gulf, where the military sees the, highest risk of germ warfare. The Pentagon has expended millions of dollars and a huge amount of energy on the mass in- . oculations, which defense officials portray as an un- fortunate but necessary response to a rising threat. The program was spurred by U.N. weapons in- spectors’ discovery in the mid-1990s that Iraq had tried to develop germ weapons and had stockpiled 8,000 liters of anthrax spores before the 1991 Gulf W far, . So far, 450,000 members of the U.S. military have received a total of about 1.8 million anthrax vaccina- tions. But the program has provoked controversy within the armed forces, with about 350 service menibers refusing to take the vaccine out of concern about its possible side effects. Several dozen have been court-martialed, and others have been allowed to leave the military. Robertson, an expert_in ‘biological :warfare, has Tugspay, JULY 18, 2000 AéL Testifying at a House hearing Thursday on the anthrax vaccine program were, from left, Army Gen. Tommy R. Franks Jr., Deputy Defense Secretary Rudy de Leon, and Marine Major Gen. Randall L. West. been analyzing Defense Department test records ob- tained by Mark Zaid, executive director of the James Madison Project, Which seeks to reduce government secrecy. Zaid is also an attorney representing several service members who are resisting the sata vac- cinations. rs ° Zaid and Robertson conceded that being ill for as long as two weeks is better than dying, the likely fate of those who aren’t inoculated or treated quickly with antibiotics after exposure to anthrax. But they said the Pentagon has failed to disclose publicly that the vaccine doesn’t confer full immunity to the dis- ease. “The Defense Department is telling people that anthrax vaccination will protect them 99 percent,” said Robertson, a retired Army Reserve colonel who formerly worked at the Army’s Infectious Diseases Institute and is now an executive at BioReliance Corp. in Rockville. “It doesn’t tell them they will be incapacitated for two weeks.” Anthrax is an acute infectious disease carried by spore-forming bacteria. It usually occurs in farm ani- mals but can be contracted by humans through taint- ed meat or, more rarely, inhalation of the spores. When inhaled, it first causes cold-like symptoms and is almost always fatal within a week unless treated immediately by antibiotics. The Pentagon’s main Web site on anthrax (www.anthrax.osd.mil) seeks to reassure service members about the safety of the vaccinations but does not provide many details about the vaccine’s ef- fectiveness. Tests on monkeys “lead us to expect that anthrax vaccine would be quite effective in preventing in- _ haled anthrax,” it says. What it, doesn’t say is that some of the monkeys became yery ill. Zaid and Robertson analyzed the laboratory note- books from one of the tests conducted on 10 immu- “’ nized rhesus monkeys and a control group of five an- imals at the Army’s infectious diseases institute. Eek: 3 BY RAY LUSTIG—-THE WASHINGTON POST After being fully vaccinated, the monkeys were ex- posed to a highly lethal dose of aerosol spray of an- thrax on June 13, 1991. “Although all vaccinated monkeys survived, they appeared to be sick over the course of two Weens,” the lab report states. Robertson noted that the monkeys sickened even though they had been given significantly larger dos- es of vaccine than humans receive, relative to their weight, Col. Arthur Friedlander, a senior scientist at the institute, rejected Robertson’s interpretation of the data. “Tt would be a misstatement to take away from the lab notebook that immunized animals when chal- lenged with anthrax are uniformly incapacitated,” Friedlander said. “That is a gross overstatement.” He and other officials at the institute said they don’t know for sure whether every animal in the 1991 test fell iil and don’t think any were sick for two full weeks. In another test last year, they said, 18 of 20 immunized monkeys survived. exposure, ani none were sickened. ’ . “We doit think that incapacitation of large num- bers of troops would occur,” said Col. Edward Bit- zen, the institute’s commander. But if it turns out that even fully inoculated sol- diers would be unable to fight after exposure to an- thrax, the implications for U.S. military operations are enormous, said Chris Seiple, a former Marine of- ficer who serves on a panel studying chemical and bi- ological warfare issues at thé Center for Strategic and International Studies. In addition to the military issues of how to protect troops and resnoud to such an attack, Seiple said he worries about the effect on public opinion. “People have been led to believe that you can be hit with this stuff and still be mission-ready,” he said. “If you had a bunch of people taken prisoner bécaus€ tliey Were sick, you'd have a loss of public confidence.”