-Caveat Lector-
Anthrax Shot May Be Factor in Death
Army National Guard Sgt. Audrey Towne fills a needle with anthrax vaccine in
Bismarck, N.D., Jan. 3. The death of a BioPort worker may be connected to
the company’s manufacture of the anthrax vaccine. (Will Kincaid/AP Photo)
The Associated Press
L A N S I N G, Mich., Sept. 28 — A medical examiner says BioPort Corp.’s
anthrax vaccine may have contributed to the July death of one of the workers
with the troubled company.
But the company’s chief executive officer, Bob Kramer, said in a
statement released this morning that he doesn’t believe the death and
vaccine are connected.
BioPort is the sole producer of the U.S. military’s vaccine to combat
the biological weapon of Anthrax. In July, the Pentagon slowed down its
controversial program of inoculating all military personnel because of a
shortage of the vaccine. Some military personnel have refused the shots,
saying the vaccine is unsafe.
“Those of us who work here are confident that there is no connection
between his death and the anthrax vaccine,” Kramer said. He pointed out the
death certificate states that the immediate cause of death was ventricular
arrhythmia and said there is no reference to any underlying cause.
‘Inflammatory Response’
The deceased, Richard Dunn, had worked for BioPort and its Michigan
state-owned predecessor since 1992. He cared for and monitored test animals
and was required to take the same vaccine given to hundreds of thousands of
U.S. military personnel. Dunn received 11 doses, the last one in April.
An August autopsy showed Dunn, 61, had an “inflammatory response” to
the vaccine throughout his body, Ionia County Chief Medical Examiner Robert
Joyce said. Joyce did not perform the autopsy, but as the county’s medical
examiner he is responsible for recording results.
BioPort bought the former state-owned Michigan Biologic Products
Institute in 1998. Because it has yet to win federal approval of its
renovated labs, the company has been unable to make new vaccine. Instead,
BioPort has relied on vaccines made when the state owned the lab.
Earlier this month, it recalled three of its products — including some
doses of the military’s anthrax vaccine — because of labeling and
contamination concerns.
Going Broke
BioPort already is struggling to survive financially. Despite an $18 million
advance in 1999 from the U.S. military — its largest customer — the company
told the Pentagon early this year that it faced a possible cash shortfall of
up to $18 million for 2000.
Since then, BioPort has received additional Pentagon money to stay
afloat.
Joyce would not release the autopsy results Wednesday. BioPort
officials say they also were denied a copy of the autopsy Wednesday.
BioPort officials said Dunn’s death certificate indicated he died of a
heart condition, and they hadn’t been told the autopsy indicated otherwise.
“This is information we absolutely need to look into and don’t take
lightly,” BioPort spokeswoman Kelly Rossman McKinney said. “We’re puzzled
and stunned. We’re going to do everything we can to find out what’s going on
here.”
Unprecedented Reaction?
BioPort said it contacted the Pentagon, the Centers for Disease Control and
Prevention, the U.S. Food and Drug Administration and vaccine experts after
receiving the information from Joyce.
Company officials expect tissue samples taken from Dunn to be turned
over to national medical authorities for further review.
Workers at the north Lansing labs have taken the vaccine for 30 years.
More than half of BioPort’s 210 workers have received the six-dose vaccine,
which also requires an annual booster.
The most serious reaction among employees has been a severe headache,
said Condalee Decker, the company’s nurse. There have been no reports of
reactions similar to Dunn’s, even to a lesser degree.
A month after Dunn received his 11th dose, he complained of fatigue and
swelling, said Mike Tanner, BioPort’s personnel director. The company’s
doctors determined his symptoms had no connection to the vaccine, Tanner
said.
The military reports that 487,098 people had received 1.9 million doses
of the vaccine through last week. About 400 military personnel, worried
about the impact on their health, have resigned or faced disciplinary action
rather than take the vaccine.
Fewer than one half of 1 percent of the people who have taken the
vaccine, 1,152 people, reported adverse reactions.
A U.S. Health and Human Services review confirmed that 592 of the cases
were certainly or probably caused by the anthrax vaccine. They classified
123 of the cases as serious, all due to allergic reactions. There were no
fatalities among those cases.
The military and the FDA say the anthrax vaccine is safe, with no more
side effects than many common vaccines.
The Pentagon says more than 1,500 vaccinated lab workers at a research
and development center at Maryland’s Fort Detrick have been tracked for 20
years, with no unexplained symptoms.
Critics say a long-term study on the effects of the vaccine is needed
to make sure it is safe. A letter signed by 35 members of Congress in May
urged Defense Secretary William Cohen to suspend the program until a
long-term study was done.
Copyright 2000 The Associated Press. All rights reserved. This material may
not be published, broadcast, rewritten or redistributed.
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