Anthrax shots bad medicine? - Vaccine's possible perils listed in military papers
By Dwight Daniels
STAFF WRITER
Even as the Pentagon is conducting a comprehensive educational campaign to convince American troops that mandatory anthrax vaccinations are safe, military documents indicate high-level acknowledgment of potential dangers.
Documents obtained by The San Diego Union-Tribune show that Secretary of the Army Louis Caldera agreed in September 1998 to accept the burden of potential liability claims made against the vaccine manufacturer by service members.
The vaccine, according to a memo signed by Caldera, "involves unusually hazardous risks associated with the potential for adverse reactions in some recipients and the possibility that the desired immunological effect will not be obtained by all recipients."
Moreover, the secretary concluded, there is no certainty that the anthrax used in tests to measure the vaccine's effectiveness "will be sufficiently similar to the pathogen that U.S. forces might encounter" during warfare.
Caldera's decision to indemnify Michigan-based BioPort Corp., which will manufacture about 6.3 million doses of the vaccine under a single-source contract with the government, means the company would not have to bear the costs of lawsuits contending the vaccine caused adverse reactions or failed to protect service members against anthrax. The government instead would be liable.
The Army is the lead agency in acquiring the vaccine for all of the armed forces.
A Pentagon spokesman said the last government indemnification of a vaccine manufacturer came in 1976 and involved the controversial swine-flu vaccine.
The government does, however, indemnify other companies that take on hazardous work such as disposing of chemical weapons, the spokesman said.
Mark Zaid, a Washington, D.C., lawyer who represents some service members who have refused to take the vaccine, said the indemnification documents appear to support concerns about potential side effects.
"It seems the military has categorically adopted our arguments against the vaccine," said Zaid, who helped represent five Marines court-martialed this month at the Marine Corps Air Ground Combat Center in Twentynine Palms.
Department of Defense officials last week insisted, as they have all along, that the vaccine is safe, regardless of the language in the indemnification agreement.
Spokesmen downplayed the wording of Caldera's letter, saying the lawyerly language in it describes unlikely, worst-case scenarios.
"It's legalese," said Army Col. Dick Bridges, a senior Defense Department spokesman. "It's like The San Diego Union-Tribune buying libel insurance. You don't expect to libel anyone, but you can't say it's never going to happen."
Other Pentagon spokesmen noted that even the most routine procedures in civilian doctors' offices usually are not done until patients sign forms acknowledging the potential for grave side effects.
The Defense Department believes the armed forces face a threat from rogue nations such as Iraq that have developed weapons capable of delivering anthrax. Spokesmen have said it would be immoral to fail to provide troops with the best protection available.
Anthrax is spread by dustlike spores, which can be inhaled. Death, from internal bleeding and inflammation, can follow within days.
Granting freedom from liability to BioPort "will facilitate the national defense," Caldera wrote.
The Pentagon embarked on the $130 million anthrax inoculation campaign in March. Plans call for 2.5 million active-duty personnel and reservists to receive six injections over an 18-month period. Those shots will be followed by an annual booster.
About 220,000 men and women have been inoculated so far. Forty-two have reported adverse reactions, according to the Pentagon, but all have recovered. The reactions generally have been less serious than those caused by flu vaccines routinely given to members of the military, spokesmen said.
Nonetheless, as many as 200 service members have refused the inoculations, citing concerns that they could cause everything from dizziness and nausea to chronic fatigue syndrome, cancer and infertility.
All five of the Marines court-martialed at Twentynine Palms for failing to obey an order to take the vaccine were convicted, including two yesterday. They are Lance Cpl. Michael McIntyre, 22, of Mount Vernon, Wash., who was given 30 days in confinement and a bad-conduct discharge, and Lance Cpl. Jared Johnston, 19, of Henryetta, Okla., who received 25 days in confinement and a bad-conduct discharge.
The previous three, including Lance Cpl. Michael Metzig, 20, of Paradise Hills, received similar sentences.
About 30 Camp Pendleton Marines have refused the vaccine.
"This is another stunning example of the misleading and false statements made by senior military leaders about the vaccine's safety," Zaid said. "It appears to indicate either the service members are just and correct in their reasons for refusing the shots, or the Army has blatantly distorted the true picture of the vaccine's safety."
Zaid is executive director of the James Madison Project, which has represented whistle-blowers and those who believe they have been harmed by the government.
He also has represented families of those who were killed aboard Pan Am Flight 103 in December 1988, filing a lawsuit alleging that the Libyan government was behind the bombing.
Military officials have regularly pointed out that the anthrax vaccine has been approved by the U.S. Food and Drug Administration and has been in use for 30 years. It is used primarily by veterinarians and others who work with animals, since anthrax bacteria occur naturally in livestock.
Defense officials also point to evaluations by nonmilitary scientists such as Dr. Kathryn Zoon, director of the Center for Biologics Evaluation and Research at the Food and Drug Administration, who have backed the vaccine's safety.
In April, Zoon testified before Congress that her organization's scientists "believe (the) anthrax vaccine is a safe and effective vaccine for the prevention of anthrax disease, an often fatal disease."
She said, however, that "numerous significant deviations" from federal regulations by BioPort were earlier observed by FDA inspectors, causing some of the vaccine to be quarantined. In recent months, though, the company has improved its practices and showed "commitment to corrective actions."
Vaccine production there now should be trouble-free, Zoon told the subcommittee.
The issue of how the contractor was selected will be discussed tomorrow before the House Subcommittee on National Security, Veterans Affairs and International Relations, headed by Rep. Christopher Shays, R-Conn.
Shays and other Congress members have previously called on Secretary of Defense William Cohen -- who, like other military leaders, has taken the anthrax shots himself -- to explain why the program was set up using just one firm.
"The Pentagon is locked in a dependent relationship with a new, unproven company," Shays said from his Capitol Hill office last week. "Resting on so weak a foundation, the anthrax vaccine program may not be safe or sustainable."
Shays' staffers noted the Pentagon already has spent nearly $17 million of taxpayers' funds to upgrade BioPort's Lansing, Mich., plant.
The court-martialed Marines at Twentynine Palms are appealing their convictions.
"I am proud to have served as a Marine, (and) if necessary, I would gladly die for my country," Lance Cpl. Jared Schwartz told a military judge earlier this month before he began a 30-day term in the brig.
"At the same time, I have been taught to stand by my beliefs no matter the consequences," the 20-year-old Kentucky native said. "On the one hand, the Marines say the vaccine is for our own protection. On the other hand, we are not permitted to exercise our constitutional and individual rights to control the substances placed in our bodies.
"And when we try, we find ourselves being prosecuted alongside drug users, thieves and rapists," Schwartz added before he was handcuffed and led from the courtroom.
STAFF WRITER
Even as the Pentagon is conducting a comprehensive educational campaign to convince American troops that mandatory anthrax vaccinations are safe, military documents indicate high-level acknowledgment of potential dangers.
Documents obtained by The San Diego Union-Tribune show that Secretary of the Army Louis Caldera agreed in September 1998 to accept the burden of potential liability claims made against the vaccine manufacturer by service members.
The vaccine, according to a memo signed by Caldera, "involves unusually hazardous risks associated with the potential for adverse reactions in some recipients and the possibility that the desired immunological effect will not be obtained by all recipients."
Moreover, the secretary concluded, there is no certainty that the anthrax used in tests to measure the vaccine's effectiveness "will be sufficiently similar to the pathogen that U.S. forces might encounter" during warfare.
Caldera's decision to indemnify Michigan-based BioPort Corp., which will manufacture about 6.3 million doses of the vaccine under a single-source contract with the government, means the company would not have to bear the costs of lawsuits contending the vaccine caused adverse reactions or failed to protect service members against anthrax. The government instead would be liable.
The Army is the lead agency in acquiring the vaccine for all of the armed forces.
A Pentagon spokesman said the last government indemnification of a vaccine manufacturer came in 1976 and involved the controversial swine-flu vaccine.
The government does, however, indemnify other companies that take on hazardous work such as disposing of chemical weapons, the spokesman said.
Mark Zaid, a Washington, D.C., lawyer who represents some service members who have refused to take the vaccine, said the indemnification documents appear to support concerns about potential side effects.
"It seems the military has categorically adopted our arguments against the vaccine," said Zaid, who helped represent five Marines court-martialed this month at the Marine Corps Air Ground Combat Center in Twentynine Palms.
Department of Defense officials last week insisted, as they have all along, that the vaccine is safe, regardless of the language in the indemnification agreement.
Spokesmen downplayed the wording of Caldera's letter, saying the lawyerly language in it describes unlikely, worst-case scenarios.
"It's legalese," said Army Col. Dick Bridges, a senior Defense Department spokesman. "It's like The San Diego Union-Tribune buying libel insurance. You don't expect to libel anyone, but you can't say it's never going to happen."
Other Pentagon spokesmen noted that even the most routine procedures in civilian doctors' offices usually are not done until patients sign forms acknowledging the potential for grave side effects.
The Defense Department believes the armed forces face a threat from rogue nations such as Iraq that have developed weapons capable of delivering anthrax. Spokesmen have said it would be immoral to fail to provide troops with the best protection available.
Anthrax is spread by dustlike spores, which can be inhaled. Death, from internal bleeding and inflammation, can follow within days.
Granting freedom from liability to BioPort "will facilitate the national defense," Caldera wrote.
The Pentagon embarked on the $130 million anthrax inoculation campaign in March. Plans call for 2.5 million active-duty personnel and reservists to receive six injections over an 18-month period. Those shots will be followed by an annual booster.
About 220,000 men and women have been inoculated so far. Forty-two have reported adverse reactions, according to the Pentagon, but all have recovered. The reactions generally have been less serious than those caused by flu vaccines routinely given to members of the military, spokesmen said.
Nonetheless, as many as 200 service members have refused the inoculations, citing concerns that they could cause everything from dizziness and nausea to chronic fatigue syndrome, cancer and infertility.
All five of the Marines court-martialed at Twentynine Palms for failing to obey an order to take the vaccine were convicted, including two yesterday. They are Lance Cpl. Michael McIntyre, 22, of Mount Vernon, Wash., who was given 30 days in confinement and a bad-conduct discharge, and Lance Cpl. Jared Johnston, 19, of Henryetta, Okla., who received 25 days in confinement and a bad-conduct discharge.
The previous three, including Lance Cpl. Michael Metzig, 20, of Paradise Hills, received similar sentences.
About 30 Camp Pendleton Marines have refused the vaccine.
"This is another stunning example of the misleading and false statements made by senior military leaders about the vaccine's safety," Zaid said. "It appears to indicate either the service members are just and correct in their reasons for refusing the shots, or the Army has blatantly distorted the true picture of the vaccine's safety."
Zaid is executive director of the James Madison Project, which has represented whistle-blowers and those who believe they have been harmed by the government.
He also has represented families of those who were killed aboard Pan Am Flight 103 in December 1988, filing a lawsuit alleging that the Libyan government was behind the bombing.
Military officials have regularly pointed out that the anthrax vaccine has been approved by the U.S. Food and Drug Administration and has been in use for 30 years. It is used primarily by veterinarians and others who work with animals, since anthrax bacteria occur naturally in livestock.
Defense officials also point to evaluations by nonmilitary scientists such as Dr. Kathryn Zoon, director of the Center for Biologics Evaluation and Research at the Food and Drug Administration, who have backed the vaccine's safety.
In April, Zoon testified before Congress that her organization's scientists "believe (the) anthrax vaccine is a safe and effective vaccine for the prevention of anthrax disease, an often fatal disease."
She said, however, that "numerous significant deviations" from federal regulations by BioPort were earlier observed by FDA inspectors, causing some of the vaccine to be quarantined. In recent months, though, the company has improved its practices and showed "commitment to corrective actions."
Vaccine production there now should be trouble-free, Zoon told the subcommittee.
The issue of how the contractor was selected will be discussed tomorrow before the House Subcommittee on National Security, Veterans Affairs and International Relations, headed by Rep. Christopher Shays, R-Conn.
Shays and other Congress members have previously called on Secretary of Defense William Cohen -- who, like other military leaders, has taken the anthrax shots himself -- to explain why the program was set up using just one firm.
"The Pentagon is locked in a dependent relationship with a new, unproven company," Shays said from his Capitol Hill office last week. "Resting on so weak a foundation, the anthrax vaccine program may not be safe or sustainable."
Shays' staffers noted the Pentagon already has spent nearly $17 million of taxpayers' funds to upgrade BioPort's Lansing, Mich., plant.
The court-martialed Marines at Twentynine Palms are appealing their convictions.
"I am proud to have served as a Marine, (and) if necessary, I would gladly die for my country," Lance Cpl. Jared Schwartz told a military judge earlier this month before he began a 30-day term in the brig.
"At the same time, I have been taught to stand by my beliefs no matter the consequences," the 20-year-old Kentucky native said. "On the one hand, the Marines say the vaccine is for our own protection. On the other hand, we are not permitted to exercise our constitutional and individual rights to control the substances placed in our bodies.
"And when we try, we find ourselves being prosecuted alongside drug users, thieves and rapists," Schwartz added before he was handcuffed and led from the courtroom.
