American Journal of Law & Medicine

Protecting soldiers from friendly fire: the consent requirement for using investigational drugs and vaccines in combat.(Law, Medicine and Socially Responsible Research)

This could be the world's largest friendly fire incident.(1)

I. 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.(7) FDA had granted Rule 23(d) waivers for the use of two agents, pyridostigmine bromide thirty mg tablets (for use as a "pretreatment" prior to nerve gas attack) and pentavalent botulinum toxoid vaccine (to protect against botulism in biological warfare).(8) These were the only waivers that have ever been granted under the rule.(9)

U.S. District Judge Stanley Harris made it clear that he had no desire to get involved with military matters.(10) In his words, "DOD's decision to use unapproved drugs is precisely the type of military decision that courts have repeatedly refused to second-guess."(11) He characterized the decision as one to protect individual servicemen and as "strategic" in nature, and thus not reviewable by a court.(12) He went on to say, however, that if he thought he had the authority to review the military's decision, he would uphold it.(13)

Consistent with the Nuremberg Code, the Defense Authorization Act prohibits DOD from using any of its funds "for any research involving a human being as an experimental subject" unless the subject's informed consent has been obtained.(14) This congressional restriction was in reaction to U.S. Army experiments using both radiation and LSD on servicemen at the beginning of the cold war.(15) Judge Harris, however, found this statutory prohibition inapplicable because "the primary purpose of administering the drugs is military, not scientific."(16)

The "not feasible" exception previously had applied only to subjects who were unable to communicate, unconscious, or incompetent.(17) Nonetheless, Judge Harris decided that FDA could reinterpret the exception as long as its interpretation was not "arbitrary, capricious or manifestly contrary to the statute."(18) Finally, Judge Harris rejected the claim that forced administration of unapproved drugs violates the Fifth Amendment liberty interest of servicemen.(19) Instead, he found the military's interests in trying to prevent injury to troops and "successfully accomplishing the military goals of Operation Desert Storm" sufficient to justify the exception to informed consent.(20) The decision did not mention the Nuremberg Code.

IV. THE COURT OF APPEALS

John Doe appealed.(21) At the hearing, held in March 1991 after the war was over, the Department of Justice (DOJ) introduced a letter into evidence from DOD to FDA which stated that the military requirements for use of the two agents without informed consent had ended.(22) In the letter, DOD also informed FDA that "Central Command has recently reported that the military command in the theater of operations decided to administer the [botulinum] vaccine on a voluntary basis. The pyridostigmine tablets were used without prior informed consent."(23) On the basis of the end of the war and the DOD letter, DOJ argued that the case was moot and should be dismissed.(24)

The majority of the court, in a 2-to-1 opinion written by Judge Ruth Bader Ginsburg (now Justice Ginsburg) in July 1991, disagreed.(25) The court concluded that even though DOD had withdrawn its two specific waivers, Rule 23(d) remained in effect, and therefore the use of unapproved agents without consent was capable of both repetition and evading review.(26) The court of appeals relied heavily on government reports concerning the proliferation of nuclear, chemical, and biological weapons systems, especially among third world nations like Iraq.(27) On the merits, the court disagreed with the lower court that the case was beyond court review because it was military in nature.(28) Instead, the court of appeals defined the issue as a challenge to FDA's authority to issue a waiver of its consent regulations to DOD, not as an action challenging military decisions.(29) The court of appeals did agree, however, with all the other conclusions of the lower court.(30) Again, no mention was made of the Nuremberg Code.

Judge Clarence Thomas (now Justice Thomas) dissented.(31) He agreed with DOJ, arguing that, because the war was over and because it was virtually impossible for John Doe himself to be subjected to the rule again, the case should be dismissed as moot.(32) He said that the majority "surely overstates" the risk of future chemical warfare, noting that "after all, American soldiers have not been the victims of organized chemical attack since the First World War."(33) He also stressed that there was no "reasonable likelihood that John Doe personally" will be involved in any future war using chemical weapons.(34) Thomas stated, "The majority focuses on Rule 23(d) in the abstract--and in the process forgets about Doe, the plaintiff."(35)

V. THE COURTS AND WAR

Since the time of Cicero it has been said that inter arma leges silentae sunt--amid the clash of arms the laws are silent. This was certainly tree of the forced internment of Japanese-Americans during World War II, and was tree of the courts here as well.(36) While troops are in the field, courts are unlikely to make any decisions that make them appear to be interfering with military decisionmaking. This realpolitik is disturbing because it undermines progress in human rights, but nonetheless remains consistent. The brief history of international human rights, after all, has been written primarily in the aftermath of war: the founding of the United Nations in 1946, the Universal Declaration of Human Rights in 1948, and current efforts to foster human rights in the wake of the cold war. Neither of these two courts could acknowledge (let alone discuss) the Nuremberg Code. …

Log in to your account to read this article – and millions more.