By THOMAS D. WILLIAMS
The Hartford Courant
September 29, 2000
The anthrax vaccine, under a cloud of questions today over its safety and effectiveness, was sharply criticized by the Pentagon itself in 1989, federal documents show.
During U.S. Senate hearings about the military's readiness to combat biological warfare, then Assistant Secretary of Defense Robert B. Barker stated that "current vaccines, particularly the anthrax vaccine, do not readily lend themselves to use in mass troop immunization."
He cited two key reasons: a higher-than-desirable rate of adverse reactions to the drug, and "in some cases, lack of strong enough [effectiveness] against infection by the aerosol route of exposure.''
Two years later, however, the Pentagon authorized use of the vaccine for the Persian Gulf War, and in 1997, Defense Secretary William S. Cohen ordered a mandatory inoculation program. Coincidentally, Cohen had been a Republican senator from Maine and active participant in the 1989 hearings.
Today, Cohen and Pentagon officials say the department changed its stance because the threat of biological warfare had increased, and because newer tests showed the vaccine was safer and more effective than they once thought.
But two years after the mandatory inoculations began early in 1998, the program is under increasing attack. The military's reassessment of the vaccine since 1989, combined with the continuing questions about the program, is likely to provide new fodder for those who say the government should stop using the vaccine or make the inoculations voluntary.
More than 1,500 service people have complained about side effects of varying severity that they blame on the vaccine. Hundreds of service people have refused to be inoculated and have been disciplined or discharged, while hundreds more in the reserve and National Guard and at least 250 military pilots have resigned rather than take the six shots required. At least 250 military pilots have resigned, raising questions about U.S. battle readiness. Seasoned fighter pilots can cost as much as $3 million to train, according to Air Force pilots familiar with the process.
In September, the manufacturer of the vaccine, BioPort Corp. of Lansing, Mich.was cited for using an expired lot of the drug while failing earlier to gain U.S. Food and Drug Administration approval to make more vaccine. And this week, a newly released FDA study showed the trace amounts of an additive in sample testing of the vaccine, a direct contradiction to Pentagon statements on the issue. The FDA said the additive was in such small amounts that it could not cause health problems.
Still, the National Gulf War Resource Center, the largest veterans organization for U.S. Persian Gulf War service members, called Thursday for a federal criminal inquiry into the matter.
Also, this week, the death of a man employed by the vaccines manufacturer, BioPort Corp., was being linked to the fact that he had taken 11 doses of the vaccine while employed there.
Richard Dunn monitored test animals for BioPort Corp. and was required to take the vaccine. He died in July.
BioPort said Dunn's death certificate lists the immediate cause of death as ventricular arrhythmia and makes no reference to an underlying cause, but the county chief medical examiner said Dunn's response to the vaccine contributed to his death. The autopsy findings have not been released.
The various problems are not surprising to one of the vaccination program's most public critics, U.S. Rep. Christopher Shays, R-4th District, who leads a continuing House committee's investigation of the vaccine.
"As early as the 1980s, the Pentagon knew we needed a better vaccine,'' Shays said. "We still do.''
Cohen, however, has staunchly defended the vaccination program he launched. His spokesman, James Turner, insisted the Defense Department had far more information about the vaccine in 1997 when Cohen announced the program, than it did in 1989, when Cohen learned the military opposed it.
In particular, Turner said that in the late 1980s, the threat of biological weapons being used by an enemy was far less than it is today. Thus, he said, the potential of minor adverse reactions to the vaccination is warranted now to protect the troops from that increased threat of deadly anthrax bacteria.
Yet that's not what the U.S. General Accounting Office concluded in an inquiry completed last year for Congress. The GAO said the magnitude of the threat of biological warfare "has not changed since 1990.''
Beyond the relative threat of biological warfare, the biggest debate over the anthrax vaccination program focuses on safety, in particular the lack of studies that could determine whether the vaccine poses any long-term adverse health effects.
It has never been established whether there are more than the 1,500 soldiers the Pentagon says have suffered adverse reactions to the shots, or how many of the adverse reactions were severe or long-term. Some 445,000 of the 2.4 million people in the military have been inoculated to date. Both sides in the ongoing debate about the program have used the lack of detailed information to argue about the accuracy or inaccuracy of the adverse reaction rate.
Turner said anthrax vaccine tests in the 1990s on rhesus monkeys show the drug is safe and effective. But the manufacturing license for the anthrax vaccine specifies that tests should be conducted on guinea pigs.
And a September 1998 report by the U.S. Army Medical Research Institute of Infectious Diseases, which researches and tests military vaccines, showed the vaccine had limited success on guinea pigs.
Col. Arthur Friedlander, the Army's own expert on the vaccination who works for the same institute, made telling statements when he testified last March in a Canadian military court, where that country's use of the same vaccine
was successfully challenged by a serviceman.
Friedlander, chief of the institute's bacteriology division, testified that there is no way of scientifically knowing whether the vaccine tests on monkeys prove the drug is safe and effective for humans. Indeed, the National Institute of Medicine, answering a Pentagon request, concluded in March that medical research is insufficient to demonstrate the safety of the anthrax vaccination.
With the vaccination supply low, and the manufacturer's efforts to make new supplies still failing to receive FDA approval, the program's future is unclear.
The Pentagon is exploring the use of an antibiotic, ciprofloxacin, manufactured by Bayer Corp., whose pharmaceutical division is in West Haven, as an alternative to vaccination.
U.S. Sen. John Glenn, the former astronaut, spearheaded the 1989 congressional investigation. In a recent telephone interview, he said he continues to follow the ongoing controversy of the anthrax vaccine, and is concerned.
"Whatever we are inoculating our people with has to be tested and has to be safe,'' Glenn said.
This spring, a group of 35 congressmen, including Shays, called on Cohen to halt the vaccination program.
"In the early 1990s, the Department of Defense faced a fork in the road to effective force protection and picked the wrong path,'' Shays said.
"Had (the department) followed its own assessments of the inadequacy of the current vaccine, they could have focused on obtaining FDA approval of the modern, improved anthrax inoculation needed to meet the real military threat,'' Shays said. "Instead, precious time and money have been wasted to acquire little more than a false sense of security U.S. troops will be protected against biological warfare.''
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