Ethical considerations of the use of investigational new drugs during the Gulf War

At the onset of the Gulf War in 1992, the threat of chemical and biological weapons prompted the Department of Defense to seek a waiver from the Food and Drug Administration to use the investigational new drugs pyridostigmine bromide and botulism vaccine without first obtaining consent from those servicemen and women who would receive the drugs. The waiver was granted and came in the form of the Interim Rule, which permitted the use of investigational new drugs when consent could not be obtained because of "non-feasibility" and the nature of the military mission. The Interim Rule restricted the soldiers' rights to informed consent, but was it justified?;In this thesis, I examine the reasoning behind the use of investigational new drugs and conclude that the Department of Defense had no choice other than to give the soldiers the investigational new drugs without their consent. I first establish that the use of the investigational new drugs constituted therapy rather than research due to the drugs' established safety record and intent of the Department of Defense in administering the drugs. Secondly, through a critique of the ethical reasoning behind the use of investigational new drugs, I contend that the bioethical principles of beneficence and non-maleficence compelled the Department of Defense to administer the drugs without consent. In so doing I provide an ethical defense of the Interim Rule. Finally, I offer alternatives to the Interim Rule including revocation and anticipatory consent. I conclude by providing information on the current status of the Interim Rule and by discussing its shortcomings.