Anthrax Vaccine: Ducking the Shot

By Timothy W. Maier
tmaier@InsightMag.com

The Pentagon may run out of anthrax vaccine by the end of summer, forcing it to suspend the controversial program to inoculate the U.S. armed forces against the disease.

Need an anthrax shot? Some 2.3 million U.S. troops ordered to receive the controversial vaccine under the Clinton administration may have to take a number. If they wait too long, those who are midway through the six-shot regimen may have to start all over again.

       The blame? The Pentagon underestimated how long it would take troubled BioPort Corp., the sole supplier of the vaccine, to get its act together and obtain a license. Since purchasing the lab from the state of Michigan in 1998, the Lansing-based company has been the subject of a Pentagon inspector-general’s probe and of critical Food and Drug Administration (FDA) inspection reports (see “A Dose of Reality,” Sept. 20, 1999).

       BioPort’s woes forced the Pentagon to downshift the entire program, and now the Bush administration says there only are about 30,000 doses in stock — not enough vaccine to inoculate all the troops. Estimates are that the current supply will last until late August, says Rep. Walter Jones Jr., R-N.C., a member of the House Armed Services Committee who is trying to stop the mandated program. “It’s not working,” Jones tells Insight. “We need to close this program down.”

 
       The FDA has refused to approve the company’s license to manufacture the vaccine. Despite nearly $100 million of taxpayer investment in BioPort, the FDA continues to find serious manufacturing problems there, including the company’s inability to produce lot-to-lot consistency.

 
       “The shortage is real,” says U.S. Army Maj. Jeffrey Quinn, deputy director for operations in the anthrax-immunization program. As a result, only those in high-risk areas are receiving the vaccination until the FDA approves BioPort’s license. “We have had to prioritize. Only those in the high-threat areas — such as those in southwest Asia for more than 30 days at a time” — will get the six-dose requirement, he tells Insight.

       Jones finds all of this troubling. In a sharply worded three-page letter dated March 22 to Defense Secretary Donald Rumsfeld, the congressman called for an “immediate temporary moratorium on the mandatory vaccine program” and a review of the current policy. The letter also was signed by fellow Republican Reps. Dan Burton of Indiana, Christopher Shays of Connecticut, Curt Weldon of Pennsylvania, Ben Gilman of New York and George Nethercutt of Washington state.

       But don’t expect the program actually to be shut down, senior sources in the Bush administration tell Insight. They say the Pentagon is more than happy to review the program and, once that is done, Bush will read the recommendations and find formally that the vaccine is safe. “The question is whether you are willing to have people suffer sore arms, rather than risk troops in harm’s way with 100 percent fatalities,” says one source.

       But the letter from the concerned lawmakers comes on the heels of serious morale problems in the military over this issue. This was exacerbated because of the deaths of a U.S. Army sergeant and a lab technician who may have died due to complications from the anthrax vaccine. Both the Bush and Clinton administrations have discouraged the widespread belief that those deaths were related to the vaccination — claiming there is not sufficient evidence to warrant such a conclusion and suggesting that the Vaccine Adverse Event Reporting System (VAERS) indicates there has been an insufficient number of serious cases to halt the program.

 
       “Questions about the anthrax-vaccination safety persist,” the letter from the concerned congressmen says. “While the numbers VAERS filed with the Food and Drug Administration remain relatively small, this may be more a function of underreporting than a lack of adverse events.” As of March 15, there were 1,530 adverse reports based upon vaccination of 505,257 troops with 2,026,945 doses of anthrax vaccine. Of those, 55 individuals were hospitalized, and only 11 were confirmed by the services to be linked to the vaccine.

       But the General Accounting Office (GAO) testified before Congress late last year that as many as 60 percent of the personnel participating in a survey of individuals who have taken the anthrax vaccine failed to report their adverse reactions. Of those, 49 percent did not report adverse reactions for fear of losing flight status or concern about the effect on their careers that might result from such a report.

       Perhaps even more troubling, says Jones, is that an October 2000 FDA inspection cited BioPort as having failed to notify FDA of the possible anthrax-related death of Sgt. Sandra Larson. She had been admitted to a hospital April 7, 2000, about four weeks after receiving her sixth shot. Her sister, Nancy Rugo, testified last year before the House Government Reform Committee that Larson “was diagnosed with a serious rare blood disease, which could be considered an autoimmune disease. On June 14, 2000, twelve weeks after receiving her sixth shot, she died.”

 
       Rugo told the committee, “This was not a gradual case of aplastic anemia. She went from a healthy woman just four weeks prior to having no bone marrow or platelets and an extremely low count of red and white blood cells. It was as if there was something in her that was killing her immune system, shutting her down.”

       According to an Oct. 26, 2000, FDA report, BioPort did not reveal the death to the FDA in a 15-day report, nor did it conduct an investigation. Army Times reports that the death is under investigation by the FDA and by the anthrax-vaccine expert committee, a group of civilian physicians that reviews such incidents.

       Nor did BioPort report the death of its employee Richard Dunn, age 61, who died in July 2000, says the FDA report. He had worked in the lab since 1992, when Michigan owned the BioPort facility. Dunn had received 11 doses of the vaccine, including the last shot in April 2000. An August autopsy revealed he had an “inflammatory response” to the vaccine throughout his body, according to Ionia County Chief Medical Examiner Robert Joyce.

       Employees at the lab voluntarily have taken the vaccine for 30 years, and more than half of BioPort’s 210 employees have received the six-dose vaccine. BioPort denies that the vaccine played any role in Dunn’s death, and the company notes it did not produce the vaccine that was injected into Dunn’s body.

 
       BioPort’s chief executive officer, Bob Kramer, said in a prepared statement that “those of us who work here are confident that there is no connection between his death and the anthrax vaccine.” He noted that the death certificate states the immediate cause of death was ventricular arrhythmia and does not refer to any underlying cause. In an interview with the Lansing State Journal, Joyce countered: “Even though they didn’t find any anthrax in the man’s system, his body’s reaction to the vaccine contributed to his death.”

       Despite these and other deaths, the Pentagon remains steadfast in its belief that vaccinating all U.S. troops for deadly anthrax is worth the risk. Quinn says Larson died of a rare blood disease that doctors believe is not related to the vaccination. “What we are finding is that, when we compare those who got the shot and those who didn’t, we have discovered personnel getting sick at the same rate, which means the anthrax has had no effect whatsoever,” he says.

       Nonetheless, the fear of potential adverse effects may be taking its toll on the troops, argues Jones. “Scores of otherwise outstanding military careers have been ruined because those individuals refuse an order they thought would cause harm to them or their families,” he says in the letter.

       The number of those who say they have left the service rather than take the anthrax shots will be available soon because Congress ordered the Pentagon to track those figures beginning in October 2000. As of December 2000, Jones says, there had been 441 who had disobeyed the direct orders to take the shot. Of the refusals, 51 were court-martialed, he says. “We can’t have a volunteer program like the State Department,” says Quinn. “The military works as a team. If they don’t take the shot, they’re harming the team. Soldiers can’t arbitrarily decide not to wear a helmet or a gas mask or get the vaccine. It could impact the success of their mission.”

       The 441 refusals also do not include members of the reserves who may have resigned rather than take the shot. Jones says losing reservists, especially pilots, has been a serious problem. The GAO survey last year found 25 percent of pilots and aircrew members interviewed were leaving the service because of the anthrax-vaccination program.

       In the meantime, Connecticut Attorney General Richard Blumenthal has charged that mandating the anthrax-vaccination program for the National Guard would be illegal. He says the anthrax vaccination involves injections of an experimental drug and, under President Clinton’s Executive Order 13139, cannot be given to service members without informed consent except during an emergency. Blumenthal says the anthrax vaccine has not been proved safe or effective for its intended use because it never has been licensed for protection against inhalational anthrax. Blumenthal argues the Pentagon is using the vaccine for a program that falls outside of its license.

       The Pentagon denies the charge, and President Bush will now have to settle the argument.

Source: http://www.insightmag.com/archive/200105143.shtml