Gulf vets decry drug's approval for current Iraq War

[thedrifter]

Gulf vets decry drug's approval for current Iraq War
Rocky Mountain News

http://www.rockymountainnews.com/dr...MN_21_1734241,0
0.html
Gulf vets decry drug's approval
FDA action 'flies in face' of researchers' concerns about PB

By Dick Foster, Rocky Mountain News
February 10, 2003

Veterans of the first Persian Gulf War charge that Iraq-bound troops may be
given the same experimental drug suspected of causing illness and
disabilities in thousands of earlier Gulf War veterans.

The Food and Drug Administration on Wednesday approved the use of
pyridostigmine bromide, or PB, for U.S. combat troops to potentially reduce
the deadly effects of the nerve agent soman.

The Pentagon has not disclosed whether it will issue the controversial drug
to the estimated 200,000 U.S. troops expected in the Persian Gulf by the end
of the month. But the FDA's ruling has raised concerns among veterans.

"The FDA's action flies in the face of all scientific evidence," said Steve
Robinson, an Army veteran who heads the National Gulf War Resource Center in
Washington, D.C., which is critical of the government's response to Gulf War
illnesses. "There are no studies to show that the military application of
this drug is either safe or effective, except to say that we know it causes
illnesses in veterans."

An FDA official defended his agency's decision, saying no proven link exists
between PB and Gulf War illnesses, and the consequence of death by nerve
agent outweighs the risk of physical illness from PB.

"Soman poisoning is a fatal poisoning, so that's the potential benefit of
PB. Obviously, we're always interested in having an antidote available,"
said Dr. Robert Temple, acting director of one of the FDA's five centers for
drug evaluation and research.

Nerve agents are the deadliest chemical weapons in warfare, and Iraq is
believed to have them. A droplet on the skin can paralyze the respiratory
system and kill within minutes.

PB was seen as a possible inhibitor of one of these agents, soman. It was
issued in pill form to about 250,000 U.S. troops in Desert Storm in 1991.

The drug's effectiveness in humans has never been proved. It is ineffective
against other nerve agents believed to be in the Iraqi arsenal - sarin,
tabun and VX, scientific studies show.

Even its effectiveness against soman is questioned by some top medical
researchers, who are concerned about the potential effects of PB.

"There is mounting evidence that PB and drugs with the same mechanism do
appear to be linked to chronic health problems in Gulf War veterans," said
Dr. Beatrice Golomb, a physician and professor of medicine at the University
of California, San Diego. She wrote the 1999 Rand research report on PB and
Gulf War illness for the secretary of defense.

More than 159,000 of the 697,000 who fought in the Gulf War, about one in
four, have been granted disability benefits by the Department of Veterans
Affairs for war-related illnesses and disabilities.

The VA will not disclose how many of those are suffering from Gulf War
illness, a combination of maladies that include muscle pain and weakness,
fatigue, memory loss, sleep disorders and digestive problems.

The cause of Gulf War illness has not been determined but there are many
possibilities - including exposure to nerve and biological agents from the
bombing of Iraqi weapons plants, vaporized depleted uranium used in American
ammunition, smoke from oil well fires, inoculations and PB.

The FDA's Temple said three studies, including Golomb's Rand study, discount
PB as the cause of Gulf War illness.

"All of them conclude that you can't make the case that there's a documented
relationship. They all say that doesn't mean it couldn't be," Temple said.

But Golomb said recent studies strengthen the link between PB and Gulf
veterans' illnesses.

"There is biochemical evidence suggesting that people who have genetic
variants that make them less adept at breaking down PB are more likely to be
ill. There are studies in animals in the last couple of years showing how PB
can produce persistent injury to the nervous system," she said.

PB was designed for patients with myasthenia gravis, a debilitating
neuromuscular disease. It wasn't used as a nerve agent antidote until the
Gulf War.

No medical proof exists that the drug will protect humans exposed to nerve
agent, Golomb said. Temple said its effectiveness on humans could never be
proven without exposing people to fatal nerve agents.

As troops deployed to the Persian Gulf in 1990, the Department of Defense
directed them to take PB in tablet form. An estimated 250,000 of the 697,000
troops may have taken PB tablets, said the Office of the Special Assistant
for Gulf War Illnesses, which has no accurate records.

A law enacted in July allows the FDA to approve drugs if experiments on
animals could provide predictive parallel results for humans. FDA
experiments on monkeys and guinea pigs enabled it to approve PB for human
use, Temple said.

Robinson, of the National Gulf War Resource Center, said a subsequent law
passed by Congress last fall shields pharmaceutical companies from lawsuits
by veterans who become ill from PB.

"There's no liability in which the soldier can claim that he is ill from
this pill because it's now FDA approved," he said.

"We had 12 years to find out what was wrong with PB," Robinson said. "Now we
just throw pyridostigmine bromide in there without showing that it will work
and will not harm veterans."

fosterd@RockyMountainNews.com or (719) 633-4442


Copyright 2003, Rocky Mountain News. All Rights Reserved.


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