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CIVIL CONFLICTS


Bosnia Mission Reopens Gulf War Issue
of Informed Consent

By Annette Fuentes

Date: 12-21-95

On January 12 a special Presidential Advisory Committee on Gulf War Illnesses will hold a hearing on the issue of informed consent -- when do troops have the right to know what drugs they're being given and refuse the injections? Thousands of vets are suffering from as yet undiagnosed illnesses many believe stem in part from the drugs. But the issue of informed consent has gained new relevance in light of thousands of new Bosnia-bound troops getting injections. Annette Fuentes is an award-winning investigative reporter who has worked for Newsweek, the Daily News and the Village Voice.

Scenes of Bosnia-bound GIs baring their arms for vaccinations raise a key issue yet to be resolved from the Gulf War -- when do GIs have the right to know what's in the drugs and to refuse the injection?

The Department of Defense says the troops are getting just the basic immunizations any tourist would get -- hepatitis, tetanus, for example. But five years ago, as the first 400,000 GIs headed out to the Gulf, the Food and Drug Administration (FDA) granted waivers to the defense department to use experimental drugs on soldiers without their consent. Many Gulf vets now claim that the drugs have made them sick ever since and are one cause of the illnesses collectively called the Gulf War Syndrome.

"It's an unusually complex issue," says Phil Budhan, American Legion spokesman in Washington, D.C. "If soldiers hadn't gotten some of these medications and it ended up they were exposed to materials that made them sick, we would have been in a royal uproar. It gets into anguishing judgment calls whether to give people medication you think could be helpful that hasn't gotten FDA approval."

While the American Legion believes that "service members should know what's going into their bodies," Budhan adds, "we don't always have the luxury in a military unit of sitting everybody down and talking them through it ... . But the bottom line is that records should be kept of who gets what and how much. With the Gulf War that didn't happen."

Today, after countless studies, the illnesses affecting a reported 60,000 Gulf war vets still have no official diagnosis, although some researchers say there are strong links between the experimental drugs and vets' sicknesses. There's a real question, they claim, as to whether the army overstepped medical and legal bounds in the Gulf.

The Presidential Advisory Committee on Gulf War Illnesses apparently agrees. On January 12 it will hold hearings on the issue of informed consent for soldiers.

"We thought we all agreed after Nuremburg that you can't conduct human experiments -- even on soldiers. But in the military it's hard to distinguish between research and routine military operations," says Arthur Kaplan, a University of Pennsylvania bioethicist who was appointed to the 12-member committee by President Clinton last May. "What will national security permit? It's still not clear how experimental drugs will be handled."

On Dec. 21, 1990, at the start of Operation Desert Shield, the FDA amended its rules on informed consent, granting the DOD a waiver to use an investigational new drug (IND) on military personnel without telling them what the drug was, what risks or side effects it might have, and without offering them the right to refuse it. The waiver had been sought by the Army as part of its effort to protect troops from deadly nerve gas and germ warfare.

The FDA waivers applied to two drugs -- one an experimental vaccine for botulism, the other, pyridostigmine bromide, an anti-nerve agent pill whose only approved use is in the treatment of Myasthenia gravis, a neuromuscular disease. Some 8,000 soldiers received at least one dose of the botulism vaccine, and 400,000 troops were reportedly issued 21-pill packets of pyridostigmine bromine. No records were kept of the total number of soldiers who used the pills and in what quantity.

Lack of documentation was a major failing, says Kaplan. The waiver, he notes, did not excuse the military from rules requiring careful data collection and monitoring when using an investigational new drug.

Charles Sheehan Miles, a Gulf war vet and head of the National Gulf War Resource Center in Washington, D.C., calls this part of a "pattern of rampant disregard for the welfare of soldiers." Sheehan Miles, who served in a tank battalion in Saudi Arabia and Iraq, was assigned to get other soldiers to take their nerve-agent pills. "We should have been told that the drug was not tested on healthy humans. How do we know this isn't happening all over again with troops going to Bosnia?"

But when the consumer advocacy group Public Citizen challenged the FDA waiver at the start of the Gulf War, a district court judge dismissed the suit. The FDA had the right to consider the success of the military operation in determining whether informed consent was feasible, the judge ruled. If troops were allowed to refuse medication, many might do so, creating a medical and logistical crisis.

Sgt. Venus Hammack never feared getting shot in the Gulf War but was terrified by the prospect of a needle injecting an unknown drug. A legal specialist and Army reservist since 1973, Hammack arrived in Saudi Arabia in August 1990. On Jan. 1, 1991, a medical group came to her unit in Dhahran with medications in anticipation of chemical and biological weapons attacks.

"I'd been in a medical corps previously and knew what military medication looked like," Hammack recalls. "These didn't look right. They were unmarked, with a seven-digit code. I felt it was an experimental drug." Hammack slipped away, hoping to avoid the vaccination. Instead, she was caught and held down while the shot was administered. The next day began a series of health problems that Hammack is still fighting, including menstrual irregularity, colitis and weight loss. She blames that shot and subsequent exposures to other toxins while in the Gulf. In 1993, she was finally diagnosed with multiple chemical sensitivity by a VA doctor in her home state of Massachusetts.

"This was a situation where it was clearly feasible to let troops know drugs were experimental and what the side effects were," says Michael Tankersley, the Public Citizen attorney who filed the law suit against the FDA. Although the suit was dismissed, Tankersley says Public Citizen is looking at ways to force a repeal.

"The use of experimental drugs is an ongoing issue," he says. "It will reoccur whenever troops are sent to hot spots."

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