Protecting soldiers from friendly fire: the consent requirement for using investigational drugs and vaccines in combat.

Protecting Soldiers from Friendly Fire: The Consent Requirement for Using Investigational Drugs and Vaccines in Combat George J. Annast This could be the world's largest friendly fire incident.l INTRODUCTION In his classic treatise On War, Karl von Clausewitz emphasizes that courage is the "first quality of a warrior." He defines two types of courage: "courage in the presence of danger to the person; next, moral courage, or courage in the presence of responsibility, whether before the judgment seat of an external authority or before that of the internal authority of conscience."2 Both were involved in the U.S. military's decision to seek a waiver of informed consent requirements for the use of investigational drugs and vaccines on U.S. troops in the Persian Gulf War. The danger of chemical and biological attack was seen as demanding this waiver; while the Nuremberg Code, medical ethics, and respect for the human rights and dignity of American soldiers cautioned against it. The legal maneuvering to revise consent regulations for wartime conditions provides a case study illustrating how the boundary line between therapy and experimentation can become hopelessly blurred, the differences between law and ethics, and the ethical obligations of military physicians. II. THE NUREMBERG CODE AND THE U.S. ARMY The Nuremberg Code was promulgated by U.S. judges acting under the authority of the U.S. Army at the trial of Nazi doctors at Nuremberg in 1947.3 The defendants in the Doctors' Trial were charged with war crimes and crimes against humanity for performing both lethal and nonlethal experiments on concentration camp prisoners. Most were found guilty, and seven were hanged. The judges also enunciated the Nuremberg Code, a ten-point declaration governing human experimentation based on "principles of the law of nations as they result from the usages established among civilized peoples, from the laws of humanity, and from the dictates of public conscience." The first and central principle provides that the voluntary, competent, informed, and understanding consent of the subject is "absolutely essential." There are no exceptions for soldiers or for wartime, and until the Gulf War, the U.S. military had accepted the Nuremberg Code as their guide. The military had never argued that there should be any exception to the Code's informed consent requirement. Current U.S. statutory law also requires that informed consent be obtained for all "investigational purposes" of drugs, except where an investigator deems it "not feasible," or in his professional judgment, "contrary to the best interests of [the subjects]."4 In 1990, following Iraq's invasion of Kuwait, the Department of Defense (DOD) sought a waiver of the informed consent requirements of existing human experimentation regulations from the Food and Drug Administration (FDA). With this waiver, DOD could authorize military use of investigational drugs and vaccines on soldiers involved in the Gulf War without their informed consent. The basis of the waiver request was military expediency. In DOD's words: "In all peace time applications, we believe strongly in informed consent and ethical foundations. . . but military combat is different." DOD's rationale was that informed consent under combat conditions was "not feasible" because some troops might refuse to consent, and the military could not tolerate such refusals because of "military combat exigencies."5 FDA granted the request and issued a new general regulation, Rule 23(d), which permits drug-by-drug waiver approval on the basis that consent is "not feasible" in a "specific military operation involving combat or the immediate threat of combat."6 III. THE DISTRICT COURT Shortly after the regulation was promulgated, and just prior to Operation Desert Storm, Sidney Wolfe's Health Research Group (a part of Public Citizen Litigation Group) brought suit on behalf of an unnamed soldier (John Doe) and his wife to enjoin DOD from using Rule 23(d) drugs and vaccines on troops in the Gulf without consent. …