Februrary 3, 2005
By Marc Kaufman
The Pentagon has taken a major step toward reviving its controversial program of giving anthrax vaccine to service members, invoking emergency provisions of the Project BioShield Act that allow use of unapproved drugs and vaccines.
The Department of Defense said use of the vaccine will be voluntary for now, in contrast with the mandatory program that was blocked by a federal judge in October on the grounds that the vaccine was never properly cleared for use by the Food and Drug Administration.
The special authorization follows determinations by the Defense Department and former Health and Human Services secretary Tommy G. Thompson that a formal anthrax emergency exists for troops stationed in some nations abroad.
"The Department's current intelligence community assessments establish that there is a heightened risk for U.S. military forces of attack with anthrax," a DOD official said. He said the assessment applies to Iraq, Afghanistan and North Korea in particular.
The emergency measure marks a dramatic turn in the Defense Department's long-running efforts to establish and maintain a mandatory vaccination program to protect against inhaled anthrax. Six former or current service members sued the department in 2003 over the program, and U.S. District Judge Emmet G. Sullivan ruled last fall that the vaccinations were illegal and permanently enjoined their use.
In an order posted online Monday, however, acting FDA Commissioner Lester M. Crawford said that after conferring with the National Institutes of Health and the Center for Disease Control and Prevention, he had authorized the use of the vaccine under the BioShield Act. The order set several conditions -- that troops be educated about the vaccine and given the opportunity to refuse -- but did not present any other obstacles to renewing the program.
Crawford wrote that the "known and potential benefits of the [vaccine] outweigh the known and potential risks," and that there is no adequate substitute for it.
A DOD official said yesterday the issue will be revisited in Sullivan's courtroom before the vaccination program resumes. The process, he said, "could take some time."
That assessment was reinforced yesterday by the six service members' lawyer, who said he would go to court to oppose any effort to quickly revive the program. John J. Michels said the injunction remains in force despite the emergency authorization and despite the department's new willingness to accept a voluntary vaccination program.
Michels also argued that the emergency provisions of the BioShield Act were being misused. "The emergency here is that the department lost the case in court, and invoking an emergency on that basis is a terrible precedent," he said.
Anthrax is a deadly infectious disease caused by the spore-forming bacterium Bacillus anthracis. Early symptoms may resemble a common cold, but after several days the symptoms can progress to severe breathing problems and shock. Inhalation anthrax is usually fatal; a cutaneous form that affects the skin is less lethal.
A month after the Sept. 11, 2001, terrorist attacks, letters tainted with anthrax bacteria infected people in New York, Connecticut, New Jersey, Florida and Washington. The still unsolved attacks killed five people, sickened 17 and put about 10,000 on antibiotics.
Michels said he was pleased by the department's change of position making the program voluntary, because that had been a central goal of the lawsuit. "But we're concerned that this may be a half-step that will later lead to a resumption of mandatory vaccinations," he said.
Asked whether the Pentagon would like to return to a mandatory program, the spokesman left the possibility open. He said a major consideration in accepting a voluntary program was that the emergency authorization is good for only six months unless the FDA extends it.
"Depending on the outcome of FDA's administrative review, DOD will then revisit this issue," he said.
The controversy over the anthrax vaccine is grounded in a dispute over whether it was ever properly tested for human use. The Defense Department and the FDA concluded, based on studies including clinical trials done in the 1950s testing the vaccine against cutaneous anthrax, that the vaccine is safe and effective for inhaled exposure, as well. But Sullivan ruled that the FDA had not properly examined the scientific issues and ordered the government to use its normal procedures in determining whether the vaccine should be used.
The BioShield Act explicitly allows the FDA to approve drugs and vaccines that have not been fully tested during times of declared emergency.
The lawsuit that blocked the program focused largely on the vaccine's effectiveness of the product and whether the FDA broke its own rules in approving it in December 2003. But the most active concern has been over safety, especially side effects that include immune disorders, muscle pain and birth defects.
Almost 500 active-duty service members have refused to take the vaccine, and more than 100 have been court-martialed as a result. According to the Defense Department, 18 service members were discharged in 2003 for refusing, and a total of 436,515 were vaccinated.
In its package insert, BioThrax, the maker of the vaccine, reports that more than 2 million people were inoculated between 1990 and late 2001, and it received 1,850 reports of adverse reactions. About 6 percent of those calls involved serious and life-threatening reactions. Researchers generally estimate that the number of adverse reactions is 10 times as great as the number reported.
In his October ruling, Sullivan said the FDA had not followed proper procedures in approving the vaccine. The application was made in the mid-1980s, but it lay fallow for years. When the Defense Department learned in 2003 that the vaccine had never been formally approved, the FDA quickly re-reviewed the old application and approved it.