- In a recent letter to the Food and Drug
Administration, the Pentagon asked for broad authority to distribute to
U.S. civilians -- during or after a domestic terrorism incident -- some
of the same experimental drugs and vaccines used on troops to unknown effect
in the gulf war. In most cases these are drugs, or uses of drugs and vaccines,
that have never been tested in a clinical trial for effectiveness or side
effects and that are not at present for sale commercially.
- The Pentagon is seeking not only broad
authority to give out these drugs during terrorist emergencies but also
to waive FDA rules meant to ensure the safest use of experimental drugs:
requirements such as keeping track of who gets what drugs, proper labeling,
monitoring of side effects and fully informing patients of possible complications
before they give their consent.
- The FDA is concerned, because as it and
the Presidential Advisory Committee on Gulf War Illnesses recently documented,
the Pentagon has a terrible record in using such drugs and vaccines both
in Desert Storm and more recently in Bosnia.
- Just before Desert Storm, the FDA allowed
the Pentagon to give troops several experimental drugs and vaccines not
approved for commercial sale. Among them were pyridostigmine bromide (PB),
a drug believed to be effective in fending off the effects of chemical
and nerve agents; botulinum vaccine and antitoxin medicine to combat biological
weapons other than anthrax; and anthrax post-exposure treatments. The FDA
also allowed the Pentagon to waive informed consent, in some cases making
it mandatory that the troops take the pills or vaccines without full knowledge
of possible risks.
- Early research suggests that the interaction
of PB with wartime stress, pesticides and other hazardous materials present
in Desert Storm may be a trigger for "gulf war illness." PB may
have been taken by as many as 500,000 troops and botulinum vaccine by about
8,000, although some information still is classified.
- After the war, the FDA, in reviewing
the Pentagon's compliance with the minimal wartime conditions the agency
had laid down, found that "deviations" from the rules "pointed
out an underlying inability for the Defense Department to carry out its
obligations" under the rules for handling experimental substances.
For example, only about half of the troops surveyed by the Pentagon received
required information about PB; no records were kept of troops who had adverse
reactions to the PB pills; and no notation in permanent medical records
was made of those who took botulinum vaccine, making it impossible to study
its long-term effects.
- The Pentagon, chastised, promised the
FDA it would do better next time. Bosnia was that next time.
- In Bosnia, the Army was authorized to
dispense an experimental vaccine for tick-borne encephalitis, a disease
common in the Balkans. In its recent review of that program, the FDA criticized
the Pentagon for failing again to document immunizations in soldiers' permanent
medical records and for touting the vaccine in handouts given to troops
as "very safe and extremely effective" when the FDA never authorized
such glowing language. The FDA at last is considering rescinding its permission
for the Pentagon to use some experimental drugs on troops in wartime without
- The President's Committee on Gulf War
Illnesses was even more critical of the Pentagon's performance with unapproved
drugs in the gulf war and Bosnia, saying the Pentagon "currently is
incapable" of handling such drugs, and that its poor performance has
hampered research into the causes of gulf war illness.
- Against this background, the head of
defense health affairs boldly is requesting from the FDA more authority
to use some of these same substances not only on troops but on civilians
in case of domestic terrorism involving chemical and biological weapons,
with the same protocol waivers that the FDA already has noted the Pentagon
is incapable of honoring.
- The Department of Defense, understandably
and correctly, wants as much flexibility as it can have during times of
national emergency to protect troops and civilians at home from these weapons
of mass murder.
- But if Americans are in imminent danger
of dying by the thousands from biological and chemical weapons at home,
then the Pentagon and the White House should do a better job leveling with
the people and Congress about the precise nature of the threat and how
imminent it may be, and then begin a debate on how far the Pentagon should
go in injecting itself into civilian emergency care.
- The writer is a managing editor at Army
Times Publishing Co.
- © Copyright 1998 The Washington