Military allowed to administer unapproved drugs


WASHINGTON -- A federal judge Thursday allowed the Defense Department to give unapproved drugs to Americans in Operation Desert Storm, saying he would not second-guess 'strategic military decisions' in the war against Iraq.

The lawsuit had been filed by an unidentified Army serviceman and his wife, who argued that the unapproved drugs could not be legally administered without the prior 'informed consent' of the military personnel.


Some of the drugs have not been approved by the Food and Drug Administration. The unapproved drugs include formulas designed to counteract the effects of nerve agents and a vaccine to prevent bacterial poisoning during biological warfare.

In rejecting amotion for a preliminary injunction, U.S. District Judge Stanley Harris said, 'The court declines to second-guess the Defense Department's decisions regarding how to equip and prepare the armed forces for the war with Iraq.'

A Pentagon official said, 'We are obviously pleased by the outcome. We believe the request made of the FDA and its subsequent approval of our request was both medically and legally defensible. It appears that the legal process has found that to be the case as well.'

The suit was brought by the Public Citizen Health Research Group, which said it would 'vigorously appeal' to the U.S. Court of Appeals.


Dr. Sidney Wolfe, director of the group, said: 'We just don't think that in the United States the military ought to be allowed to treat soldiers as though they are human guinea pigs.'

Because of the ruling, he said, an officer could threaten a soldier with court martial after refusal to take one of the drugs.

'We believe that simply by being a soldier in the military, you don't have to waive your fundamental human rights of informed consent for experimental drugs,' Wolfe said.

The suit named Defense Secretary Dick Cheney and Health and Human Services Secretary Louis Sullivan. It named Sullivan because the FDA adopted an interim rule allowing the military to administer the unapproved drugs.

In his 14-page ruling, Harris wrote, 'A long line of cases backs (the) argument that courts should not intrude on the 'established relationship between enlisted military personnel and their superior officers.''

The Defense Department's decision 'to use unapproved drugs is precisely the type of military decision that courts have repeatedly refused to second-guess,' Harris said.

'The Defense Department has elected to administer the drugs because of its determination that the drugs will improve the survival rate of troops that may encounter chemical and biological weapons,' Harris said.


The FDA is correct in recognizing 'that certain military concerns may make obtaining informed consent from military personnel in combat impracticable,' Harris said.

'A decision not to send military personnel who refuse the drugs into battle could have a significant impact on battle strategy and the success of the mission,' Harris ruled.

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