By THOMAS D. WILLIAMS
This story ran in the Courant July 21, 1999
Newly obtained U.S. Army and other military documents raise
questions about the anthrax vaccine's safety and effectiveness in
light of the positive way the U.S. Department of Defense has been
advertising the vaccine.
The documents, from U.S. Army files, and interviews of doctors
and others studying the vaccine reveal:
* Tests and studies of the vaccine on humans who were later
exposed to anthrax do not prove it is effective against airborne
anthrax spores used in biological warfare.
* The military is relying on laboratory tests of vaccinated
monkeys exposed to airborne anthrax spores. Human responses to
anthrax spores are assumed by scientists to be somewhat similar, but
not identical to animal reactions.
* There have been no published, widespread studies of the
long-term health effects of the vaccine on humans despite complaints
from some of those injected that they are suffering from symptoms
consistent with adverse reactions to the vaccine.
Inhaled anthrax is lethal to those who are unprotected. More than
307,000 military personnel have received the shot since 1998 under a
mandatory program.
Those who refuse to take the shots -- estimated at several
hundred -- are being court-martialed. At least 155 people in the Air
National Guard have resigned rather than take it.
The vaccine's safety will be discussed at a hearing today before
a House subcommittee on national security, co-chaired by U.S. Rep.
Christopher Shays, R-4th District.
The defense department has a colorful Web site on anthrax that
advertises the vaccine, approved by the U.S. Food and Drug
Administration in 1970, as ``an ordinary vaccine . . . used safely
for almost 30 years'' by a limited number of wool mill workers,
veterinarians, laboratory workers and livestock handlers in the
United States.
Army medical authorities, inside their own, less-advertised Web
site, say that ``limited human data suggests that after completion
of the first three doses, protection against [contraction of anthrax
disease through the skin] is afforded. . . . There is insufficient
data to know its efficacy against inhalational anthrax in humans,
although studies in Rhesus monkeys indicate that good protection can
be afforded after two doses . . .''
Those three studies were conducted on 43 monkeys vaccinated and
then exposed to anthrax spores. All but one survived. The defense
department's advertised Web site says the monkey data is
``compelling evidence that the vaccine series will be effective'' in
protecting humans. But in a Sept. 3, 1991, memo, then- Secretary of
the Army M.P.W. Stone said, ``Only widespread use can provide . . .
accurate assessments of the types and severity of adverse
reactions'' to the vaccine.
Dr. Meryl Nass, a Maine doctor who has studied the vaccine since
it was used in the Persian Gulf War, said tests of monkeys show
whether they die, not whether they have adverse reactions or
long-range sicknesses.
In order to know whether the vaccine protects humans and whether
it is safe and effective, humans need to be studied, most doctors
and scientists agree, Nass said.
Dr. Robert Myers, owner of the company that produced the vaccine,
said company tests on rabbits and the rigorous FDA licensing process
show it is safe.
A group of scientists and researchers will meet July 29 to
discuss a new study of the possible long-range health effects of the
vaccine on humans.