Additive Found In Anthrax Vaccine
by Thomas D. Williams
The Hartford Courant
Trace amounts of the additive squalene have been found in the anthrax vaccine used to protect U.S. service members from the biological warfare agent, federal health officials have found.
The finding contradicts repeated assertions by the Pentagon that squalene is not present in the vaccine.
The federal Food and Drug Administration said its results were based on tests of five lots of the vaccine. The agency did not make clear whether those lots containing squalene were used to inoculate troops during the Persian Gulf War, those receiving the vaccine since a mandatory inoculation program began in 1998, or both.
The FDA also did not address potential health problems with the vaccine; agency spokeswoman Lenore Gelb declined to comment.
Squalene is found in the human liver, some vegetable oils and shark oil; as an additive to a vaccine, it is used to foster a faster, stronger or longer protective reaction, according to a 1999 U.S. Government Accounting Office report. It is not approved by the FDA for use in the anthrax vaccine.
Squalene's safety was called into question when a 1999 Tulane University study of blood samples taken from sick gulf war veterans detected the presence of antibodies linked to the additive. Some of the samples were taken from soldiers who did not take part in the war; but all presumably received the vaccine.
Previously, Congress' watchdog agency, the General Accounting Office, had reported that gulf war veterans were complaining of mysterious, undiagnosed illnesses similar to patients with auto-immune disorders. A Tennessee immunologist, Dr. Pamela B. Asa, concluded those illnesses were caused by exposure to additives in vaccines, the GAO said.
James Turner, a Pentagon spokesman, said Wednesday that officials in his department were not prepared to comment on the FDA's finding.
Last year, the Pentagon challenged the Tulane University study and the implication that gulf war veterans could have become ill from the additive - even if it were in the vaccine. And if antibodies are in the veterans' blood, Pentagon officials said at the time, the tests still did not prove the veterans became sick from the vaccine.
U.S. Rep. Jack Metcalf, R-Washington, who has investigated the additive for three years, told a congressional committee Wednesday that the development raises questions about the vaccine's safety and the truthfulness of Pentagon officials.
Metcalf said his congressional inquiry concludes Pentagon officials "stonewalled" attempts to examine the vaccine's additives, an effort GAO investigators called a "pattern of deception.''
Metcalf distributed his inquiry report Wednesday to the House Subcommittee on National Security, Veterans' Affairs and International Relations headed by U.S. Rep. Christopher Shays, R-Conn.
Shays' committee is continuing a lengthy investigation into the illnesses of gulf war veterans. Shays also is among a group of congressmen who have called for an end to the vaccination program, saying the Pentagon has not proved the vaccine to be safe or effective.
Thousands of gulf war veterans complained of various illnesses in the years after the war. In addition, more than 1,500 service people inoculated since 1998 have complained about side effects of varying severity that some blame
on the vaccine.
Hundreds of service people have refused to be inoculated and been disciplined or discharged, while hundreds more in the reserve and National Guard have resigned rather than take the required series of six inoculations.
The Hartford Courant
Trace amounts of the additive squalene have been found in the anthrax vaccine used to protect U.S. service members from the biological warfare agent, federal health officials have found.
The finding contradicts repeated assertions by the Pentagon that squalene is not present in the vaccine.
The federal Food and Drug Administration said its results were based on tests of five lots of the vaccine. The agency did not make clear whether those lots containing squalene were used to inoculate troops during the Persian Gulf War, those receiving the vaccine since a mandatory inoculation program began in 1998, or both.
The FDA also did not address potential health problems with the vaccine; agency spokeswoman Lenore Gelb declined to comment.
Squalene is found in the human liver, some vegetable oils and shark oil; as an additive to a vaccine, it is used to foster a faster, stronger or longer protective reaction, according to a 1999 U.S. Government Accounting Office report. It is not approved by the FDA for use in the anthrax vaccine.
Squalene's safety was called into question when a 1999 Tulane University study of blood samples taken from sick gulf war veterans detected the presence of antibodies linked to the additive. Some of the samples were taken from soldiers who did not take part in the war; but all presumably received the vaccine.
Previously, Congress' watchdog agency, the General Accounting Office, had reported that gulf war veterans were complaining of mysterious, undiagnosed illnesses similar to patients with auto-immune disorders. A Tennessee immunologist, Dr. Pamela B. Asa, concluded those illnesses were caused by exposure to additives in vaccines, the GAO said.
James Turner, a Pentagon spokesman, said Wednesday that officials in his department were not prepared to comment on the FDA's finding.
Last year, the Pentagon challenged the Tulane University study and the implication that gulf war veterans could have become ill from the additive - even if it were in the vaccine. And if antibodies are in the veterans' blood, Pentagon officials said at the time, the tests still did not prove the veterans became sick from the vaccine.
U.S. Rep. Jack Metcalf, R-Washington, who has investigated the additive for three years, told a congressional committee Wednesday that the development raises questions about the vaccine's safety and the truthfulness of Pentagon officials.
Metcalf said his congressional inquiry concludes Pentagon officials "stonewalled" attempts to examine the vaccine's additives, an effort GAO investigators called a "pattern of deception.''
Metcalf distributed his inquiry report Wednesday to the House Subcommittee on National Security, Veterans' Affairs and International Relations headed by U.S. Rep. Christopher Shays, R-Conn.
Shays' committee is continuing a lengthy investigation into the illnesses of gulf war veterans. Shays also is among a group of congressmen who have called for an end to the vaccination program, saying the Pentagon has not proved the vaccine to be safe or effective.
Thousands of gulf war veterans complained of various illnesses in the years after the war. In addition, more than 1,500 service people inoculated since 1998 have complained about side effects of varying severity that some blame
on the vaccine.
Hundreds of service people have refused to be inoculated and been disciplined or discharged, while hundreds more in the reserve and National Guard have resigned rather than take the required series of six inoculations.
