THE VIRGINIAN-PILOT
Copyright (c) 1996, Landmark Communications, Inc.
DATE: Wednesday, May 8, 1996 TAG: 9605080439
SECTION: FRONT PAGE: A8 EDITION: FINAL
SOURCE: ASSOCIATED PRESS
DATELINE: WASHINGTON LENGTH: Medium: 60 lines
The Food and Drug Administration should revoke the military's ability to give soldiers experimental drugs without their consent because of mistakes made during the Gulf War, consumer and veterans' groups said Tuesday.
The Defense Department didn't tell the FDA that an experimental drug given to Gulf War soldiers might have hurt their chances of surviving a nerve-gas attack, said Dr. Sidney Wolfe of the consumer advocacy group Public Citizen.
The military also violated an FDA agreement that the soldiers would be told the drug pyridostigmine bromide, or PB, was experimental and would be monitored for any side effects, Wolfe charged in a petition filed with the FDA.
``These troops need the same protection every American citizen gets,'' said Charles Sheehan-Miles of the National Gulf War Resource Center, which joined the petition. ``If they are going to take experimental drugs, they need to know'' the risks.
Federal law requires that Americans be fully informed about an experimental drug before consenting to take it. But the FDA in 1991 waived that requirement when the Pentagon said it didn't have time to get consent from 600,000 troops headed for the Gulf War.
Now the FDA is considering whether to make that waiver permanent so soldiers can be given experimental drugs quickly during any military crisis.
The FDA immediately began checking files Tuesday to see if the Army had shared its research on PB, and said it would consider the petition before deciding whether soldiers' informed consent should be permanently waived.
``We're not committed to that,'' said FDA Deputy Commissioner Mary Pendergast. ``We're going to take a hard look at it.''
In a statement, the Pentagon said it would continue to use the earlier FDA waiver if an emergency arose before the FDA settles the issue. But it defended its use of PB.
PB is not FDA-approved as a pretreatment against nerve gas, but the FDA agreed to let soldiers take it based on Army animal studies showing it protected against certain types of gas, such as soman.
Had soldiers been gassed, they would have taken FDA-approved antidotes as well.
But another nerve agent, which Iraq stockpiled during the Gulf War, is sarin. Another Army animal study, which Wolfe sent the FDA Tuesday, concluded that PB pretreatment actually decreased the effectiveness of the two FDA-approved nerve-gas antidotes.
The Army submitted the sarin study for publication in a journal on Feb. 11, 1991, just weeks after the Gulf War started - and a month after the FDA agreed to let the military give soldiers PB without their consent.
The Pentagon, in its Tuesday statement, said sarin antidotes are effective enough to overcome PB's negative effects, and that PB worked so well against the gas soman that it had to be used. by CNB