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FDA RULING ON PB IGNORES SCIENTIFIC FACTS

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Jim

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Feb 7, 2003, 9:54:47 AM2/7/03
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FDA RULING ON PB IGNORES SCIENTIFIC FACTS

Veterans groups, scientist and citizens outraged.

For Immediate Release
Contact: Steve Robinson

February 06, 2003
(800) 882-1316, ext. 162

The National Gulf War Resource Center (NGWRC), the nation's leading Gulf War
veterans' advocacy organization, today demanded answers from the FDA
concerning approval of the Anti-Nerve Gas Pill Pyridiostigmine Bromide (PB)
as a pretreatment for exposure to the nerve agent Soman.

"Gulf War veterans and scientist are justifiably distressed at the
government decision to ignore the scientific evidence regarding this drug.
Documents and scientific studies conducted over the last 12 years have
clearly show this drug is both experimental and harmful," said Michael
Woods, President of the NGWRC.

â?oCitizens and soldiers alike should demand an explanation of this ruling.
The Department of Defense and the Department of Veterans Affairs have both
concluded through previous studies that PB could not be ruled out as a
factor in the illnesses Gulf War veterans currently suffer from. While the
drug may be approved for civilians who have the neuromuscular disease called
myasthenia gravis it has never been shown to be either effective or safe for
the military application against Soman,â?ť said Steve Robinson, Executive
Director of the NGWRC.

In fact, studies have shown that PB's effectiveness against Soman is
questionable. Prescribing PB as a pretreatment is a guess, and is not
proven effective by scientific fact.


Second, PB's dosing for effectiveness is variable in each individual and
would require individual evaluation due to genetics and size of the person
receiving the dose.

Third, PB is known to cause muscle damage in the animal studies cited by the
FDA with even one dose!

Fourth, PB may be in part responsible for Persian Gulf Illness. This fact
cannot be denied and has been emphasized by DoD, the Department of Veterans
Affairs, RAND, the Institute of Medicine, the VA Research Advisory Committee
on Gulf War Illnesses and veterans.

Fifth, PB can increase the effect of Sarin gas on anyone exposed. Thus, in
allowing this use, the FDA, DOD, Congress, the President and ICN
Pharmaceuticals are allowing a questionable protection against Soman and
also increasing the likelihood that troops will be more susceptible to Sarin
and possible complications after the war.

It is possible that those who made the decision think they have chosen the
lesser of two evils with the troop's protection in mind but ignoring of the
facts surrounding the risk of PB use is completely irresponsible behavior
for all concerned.

It is unfortunate that on the eve of a potential war with Iraq the FDA has
approved a drug that is known to harm veterans of the last Gulf War.

The NGWRC will continue to support the troops of the next Gulf War by asking
tough questions when they arise. Soldiers will be forced to take this drug
if ordered regardless of the potential damage.

Once again our government is putting soldiers in another type of â?oHarms
Way,â?ť which could have been prevented. This ruling in combination with
equipment deficiencies is most likely the imputes for soldiers saving their
sperm prior to deployment.

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