WASHINGTON -- A public interest group filed suit yesterday to prevent the Pentagon from administering unapproved drugs to GIs stationed in the Persian Gulf without their consent.
The suit, filed in U.S. District Court in Washington by Public Citizen, challenges a new federal rule allowing the Food and Drug Administration to exempt military personnel from regulations that people given experimental drugs be informed and willing recipients.
Under the policy, established Dec. 21 at the request of the Department of Defense, the FDA commissioner can allow the Pentagon to administer unapproved drugs and vaccines to soldiers without their consent if the commissioner deems it "not feasible" to obtain permission.
Informed consent "is a fundamental human right," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group. "This goes beyond the fringe of the usual command mentality. The Pentagon is treating U.S. soldiers as though they're subhuman."
The Defense Department, in its request for the policy change, said the threat of certain biological and chemical weapons called for use of drugs that are still being tested. It also argued that obtaining informed consent of troops was not practical in "actual or threatened" military combat.
The new policy states that the informed-consent waiver be approved on a case-by-case basis. The Pentagon, according to Public Citizen, has requested the waiver for two drugs and a vaccine -- including a drug to lessen the effects of nerve gas and one to protect the skin against nitrogen mustard, a chemical weapon.
"These drugs and vaccines will save lives and ease pain," said Jeff Nesbit, an FDA spokesman, who called the suit "an outrageous attempt to divide our troops and our country by suggesting that we are unconcerned about the health and safety of our soldiers."
"This case is not about preventing troops from getting medicines that could be helpful," said Dr. Wolfe. "It is about ensuring that those in the armed service are informed about the risks and benefits of these unapproved products and that they are permitted to make a personal informed choice."
A Pentagon spokesman refused to comment, saying only that the policy is "both medically and legally defensible."