FDA finds squalene in anthrax vaccine

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HREF= " http://www.ctnow.com/scripts/editorial.dll?bfromind=871 & eeid=3158487 & eet

ype=article & render=y & ck= & ver=2.10 " >Additive Found In Anthrax Vaccine</A>

by D.

The Hartford Courant

September 28, 2000

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.

, 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. 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.