- WASHINGTON (AP) -- The Pentagon violated federal rules in giving an encephalitis
vaccine to American soldiers in Bosnia in 1996, raising questions about
how the Defense Department performs medical research, the Food and Drug
Administration says.
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- The FDA, already probing problems stemming
from experimental drugs given to Gulf War soldiers, ordered the Pentagon
last month to submit detailed procedures to ensure it will follow FDA safety
rules.
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- The Pentagon missed the January 12 deadline,
the FDA said Monday, but has promised a response soon.
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- "We want it resolved correctly and
appropriately, because none of us knows when there will be the need to
have another deployment" in which soldiers need experimental drugs,
said FDA senior policy analyst Bonnie Lee.
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- The Pentagon is working "to improve
compliance during such circumstances in the future," said Defense
spokesman Lt. Col. Tom Begines. But he stressed that the violations were
minor and that the encephalitis vaccine has been given safely to millions
of Europeans as well as to the U.S. soldiers.
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- The issue first arose after Gulf War
troops received two experimental drugs as protection against chemical and
biological warfare, when the FDA waived usual requirements that let Americans
choose unapproved therapies only after being fully informed of the risks.
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- But the FDA says the Pentagon violated
its rules requiring that troops be told the drugs were experimental and
that strict health records be maintained to catch side effects. The drugs
now are under scrutiny for possible links to so-called Gulf War syndrome.
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- The Pentagon acknowledged problems, but
in July the FDA said it had broken the rules again -- while vaccinating
nearly 4,000 soldiers in Bosnia against tick-borne encephalitis.
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- The FDA does not consider the vaccine
dangerous -- it is widely used in Europe but not here because tick-borne
encephalitis is not a U.S. problem. Still, soldiers were inadequately warned
about side effects and the fact that the vaccine was not FDA approved,
and the 1996 vaccinations were not properly recorded in many soldiers'
medical records, the FDA said.
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- It cited a pattern of violations that
it will consider in debating how to regulate future Defense Department
research.
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