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A Promise To Do Better Is Not Enough

By Patrick B. Pexton

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 their consent.

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 Post Company

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