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Use of experimental drug on soldiers draws fire

soldiers

Congressmen: Soldiers should have been told of risks

May 8, 1997
Web posted at: 11:45 p.m. EDT

WASHINGTON (CNN) -- The decision to give an anti-nerve gas drug to troops bound for the Persian Gulf War in 1991 -- without informing them that the drug was potentially risky -- came under fire at a congressional hearing Thursday.

Lawmakers expressed concern that the actions of the Pentagon and the Food and Drug Administration violated accepted standards of medical ethics related to medical experimentation on human subjects.

"People should have been informed from the moment they set foot in the desert that this drug was not licensed and that it had side effects," said U.S. Rep. Dennis Kucinich, an Ohio Democrat. "They had time to tell the soldiers. They didn't do it."

Drug not approved by FDA

drug

The drug is question was pyridostigmine bromide, which was supposed to counteract the effects of chemical weapon attacks by Iraq. Some researchers now believe that the drug, when combined with other toxins, could be a factor in the chronic illnesses -- Gulf War Syndrome -- reported by Gulf War veterans.

At the time of the war, pyridostigmine bromide was not approved by the FDA for use as an anti-nerve gas agent. But FDA Deputy Commissioner Mary Pendergast told members of a House committee at Thursday's hearing that the agency allowed the Pentagon to go ahead and give the drug to the soldiers because it was the best preventative measure then available.

"We thought it was our best shot against nerve gas," she said. "It was better than nothing."

Pendergast said while the FDA customarily seeks "informed consent" before giving such drugs to humans, it agreed with the military that obtaining consent would not always be feasible under battlefield conditions. Some 600,000 soldiers sent to the Persian Gulf received experimental drugs.

But the FDA and the Pentagon did agree that detailed records would be kept on people who received the drugs -- a promise Pendergast now says the Pentagon didn't keep.

U.S. Rep. Christopher Shays, a Connecticut Republican, said he could understand why the military decided not to obtain consent from the soldiers. But he said he had "no sympathy" for the decision not to at least inform soldiers of the experimental nature of the drugs.

Shays said the FDA should have done more to force the Pentagon to inform and keep track of those who received the drug.

"As long as [Pentagon officials] know the FDA is going to be a paper tiger, they will continue to do this and tell the FDA to bug off," Shays said.

Informed consent required under Nuremburg Code

Nazi medical experiments on unsuspecting subjects during World War II led to the adoption of the Nuremburg Code, which requires that patients be given informed consent before being subjected to experimental procedures.

In addition to the Gulf War case, this issue of ethics also came up recently with revelations that patients in U.S.-sponsored AIDS experiments in developing countries may have been denied proven treatments.

There are a number of boards that supervise the ethics of medical experiments, although there is some concern that these boards don't have the clout to make sure ethical procedures are followed.

Satcher

Dr. David Satcher, head of the federal Centers for Disease Control and Prevention, says he believes existing mechanisms to protect patients, while strong, could be made even stronger.

"We believe that the systems that we have in place to protect subjects are better than they've ever been," Satcher said. "But we don't believe that they're good enough."

And even when informed consent is obtained, some ethicists say patients may still not fully appreciate what it truly is that they've agreed to do.

"We spend a lot of time pushing paper in front of people saying, 'Sign this,' or, 'This is your informed consent,'" said Arthur Caplan of the University of Pennsylvania. "But we never ask them, 'Did you understand it?'"

Correspondent Jeff Levine contributed to this report.  
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