Use of experimental drug on soldiers draws fire
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
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
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
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
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
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.
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
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
Correspondent Jeff Levine contributed to this report.
Related sites:Note: Pages will open in a new browser window
External sites are not endorsed by CNN Interactive.
© 1997 Cable News Network, Inc.
All Rights Reserved.