Objection to Gulf War Vaccine Was Overridden, Report Says

CLEVELAND (December 21, 1997 4:36 p.m. EST http://www.nando.net) -- An Army review board ruled it would be unethical to give soldiers heading to the Persian Gulf War an experimental vaccine without telling them the effects were unknown, The Plain Dealer reported Sunday.

However, that ruling was overridden after the Department of Defense cited national security concerns, the newspaper said.

The botulinum toxoid vaccine was given to 8,000 troops as protection against chemical and biological warfare. The soldiers were not told the vaccine, now being studied as a possible source for the variety of health problems known as "Gulf War syndrome," was unlicensed.

The mysterious ailment afflicts 80,000 veterans and civilians who were involved in the conflict.

Some think the syndrome stems from a chemical or biological attack. Others link the illness to diseases in the Middle East or smoke from oil fires.

A transcript of the ethics committee's meeting at the Army's biological defense research station in Maryland on Oct. 4, 1990, showed that Army physicians weren't confident the unlicensed vaccine would protect troops from an illness.

The transcript obtained by the newspaper showed the committee learned that while limited testing in laboratory animals showed promise against the deadly botulism toxin -- believed to be in Iraqi president Saddam Hussein's arsenal -- researchers were uncertain whether it would work.

The Food and Drug Administration requires that Americans be fully informed about an experimental drug before consenting to take it.

But in 1964, the FDA agreed to let the Department of Defense use experimental drugs to protect against battlefield exposure without following all FDA rules, including informed consent.

The Army review board decided the vaccine could be administered -- but only if the troops were told in "an abbreviated oral informed consent statement."

But the Defense Department opted not to tell the troops the vaccine was unlicensed.

The ethics committee's chairman, Col. Arthur Anderson, said there was no way to determine if the vaccine could protect soldiers.

"It would seem morally wrong to gather prospective or retrospective data on the efficacy of unproven drugs in military volunteers facing exposure to biological or chemical weapons," Anderson said.