Oct. 3, 2000, 7:18PM
Associated Press
WASHINGTON -- Despite more than 1,500 reports of adverse reactions, "no clear
patterns" have emerged in any illness said to be related to the anthrax vaccine being
given to the military, the Food and Drug Administration told Congress on Tuesday.
Mark Elengold, a deputy director at the FDA, made the declaration after a string of
witnesses at a four-hour congressional hearing, some in tears, blamed the vaccine for a
variety of diseases or the deaths of loved ones.
"I took the anthrax shot healthy and am now ill," Thomas Colosimo, a senior
airman, said. He chronicled a series of adverse reactions to four shots, including severe
weight loss and losses of consciousness.
Another witness, Nancy Rugo of Spokane, Wash., blamed the vaccine for the death of her
sister, Sgt. Sandra Larson.
Barbara Dunn of Ionia, Mich., widow of a civilian employee of the only manufacturer of the
vaccine, blamed the serum for husband Richard Dunn's death in July.
And a Navy seaman based on Okinawa, Petty Officer 3rd Class David M. Ponder, declared his
right to refuse the vaccine.
The FDA's Elengold acknowledged that the squalene molecule linked in a recent Tulane
University report to Gulf War illnesses has been found in the anthrax vaccine, but he said
it was in quantities no greater than might occur naturally in the body.
At the Pentagon, spokesman Kenneth Bacon said the FDA assured the Pentagon that squalene
was not added to the anthrax vaccine but was present as a naturally occurring substance.
"We don't know if those lots were administered to the troops," he said.
Pentagon witnesses at the hearing reiterated the decision to continue requiring anthrax
inoculations for all soldiers in the Persian Gulf area and Korea, despite vaccine
shortages.
Previously, all military personnel were required to get the shots and some face
court-martial for refusing.
Elengold said the government-run Vaccine Adverse Event Reporting System has received 1,561
reports of problems after anthrax shots, including 76 serious cases, since 1990. The
vaccine also is given to civilians who work with animals.
About 2 million doses have been administered, including more than 1.9 million to military
personnel since the Pentagon's mandatory program began. A full course to guard against
anthrax requires six shots.
"There are no clear patterns emerging at this time," Elengold said. "The
reports on anthrax vaccine received thus far do not raise any specific concerns about the
safety of the vaccine."
A panel of Pentagon witnesses echoed that assurance.
Reading a joint statement, Charles Cragin, the principal deputy defense undersecretary,
said one or more doses have been administered to 447,000 service members, with 442
refusing to obey a direct order to take the vaccine.
Two years of intensive study of complaints have identified "no unexpected events and
no disease syndromes associated with the anthrax vaccine," he said.
Rep. Dan Burton, R-Ind., House Government Reform Committee chairman, pledged further
hearings to push the military into either abandoning the program or making it voluntary.
Burton also warned the Pentagon against coercing military personnel to prevent them from
reporting adverse reactions. He offered confidentiality to any service members who come
forward.
"The Defense Department is giving this investigational vaccine without informed
consent," he said. "Doing research on our troops without their knowledge or
permission is wrong."
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