Copyright 1999 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.1999
War can radically alter the provision of medical care. The threat of biological and chemical warfare, such as troops encountered in Operation Desert Storm, for instance, raises ethical dilemmas rarely encountered in standard medical practice.
The Department of Defense (DOD) wanted to administer pyridostigmine and botulinum toxoid vaccine to protect soldiers from a possible toxic nerve gas or botulism attack by Iraqi forces. However, the DOD did not believe it was feasible to obtain informed consent from more than 500,000 military personnel.2 It argued that some personnel might refuse to consent and that refusals could not be tolerated.1 The DOD thus requested a Food and Drug Administration (FDA) waiver to allow administration of the 2 agents for unapproved use without informed consent.1,7
The FDA granted the waiver, placing military physicians in the awkward position of having to administer an agent without the recipient's informed consent.1,3,4 Can this clear departure from standard medical ethics be justified in war?
Critics of the waiver believe that the DOD was acting in the interest of its own medical research. They cite the military's violation of the Nuremberg Code, a declaration governing human experimentation created in response to the Nazis' medical experiments during World War II.1,2,5 The Code states that the consent of the research subject is "absolutely essential."1,7 Other critics have compared the DOD's decisions during Desert Storm to the Central Intelligence Agency's use of hallucinogens in the 1950s and 1960s as well as to Nazi physicians' use of unwilling experimental subjects during World War II.2
Defenders of the DOD's action disagree. A US District Court judge ruled that the Code was not applicable to the waiver because the DOD's purpose was not scientific.1,7 Many authorities affirm that the DOD's use of the pharmacological agents was preventive.2,3,5 Other defenders of the military assert that the involuntary administration of protective agents was necessary to prevent thousands of potential casualties.2 If soldiers had chosen not to take the agents, they may have been more susceptible to injury, put others at risk, and needed to be excused from combat, providing a relatively easy way for soldiers to avoid hazardous wartime duty.1,2,5
The events that took place during Desert Storm, ironically, provided evidence that voluntary administration of the agents was possible.5 While pyridostigmine was administered without informed consent, the botulinum vaccine was given on a voluntary basis, seemingly rendering the FDA waiver unnecessary.1 If the vaccine was administered with informed consent, why not pyridostigmine?
One reason for the difference in administration could have been the relative safety of the 2 agents. Pyridostigmine has been FDA approved for use in myasthenia gravis since 1955, and the doses administered during Desert Storm are considered nontoxic.2,5 In contrast, the vaccine remains an experimental agent and has never been approved by the FDA. Conflicting opinions exist regarding its safety, efficacy, and lack of FDA approval.2,5,7 These differences may explain why a US Army institutional review board voted that informed consent was required to administer the vaccine during Desert Storm.7
Another reason for the difference may have been due to military intelligence. DOD intelligence reports indicated that the Iraqi arsenal included nerve agents.4 These reports may have made administration of pyridostigmine a greater priority than administration of the botulinum vaccine. What DOD reports claimed about Iraqi possession of botulism is unknown.
It has been said amid the clash of arms, laws are silent.1,7 In this case, a fundamental medical concept, informed consent, was silenced by the clash of arms. Some intelligence information available at the time of Operation Desert Storm suggested that administering pyridostigmine without informed consent would have allowed the DOD to provide "significantly increased survival" to military personnel involved in the operation.4 Was the danger of attack, however, enough to warrant the violation of informed consent? Were military physicians, who must put priority on the success of the military mission and the needs of soldiers, ethically justified in administering medications to uninformed and nonconsenting recipients?6
Whether exception to basic ethical principles, such as informed consent, may be taken in wartime remains highly controversial. The ethical issues surrounding Operation Desert Storm raised questions about who should authorize nonstandard medical interventions during war. In the fall of 1998, Congress ruled that any decision to use unapproved drugs or vaccines in wartime must be made by the president of the United States.8
Schofer JM. Violations of Informed Consent During War. JAMA. 1999;281(17):1657. doi: