Treating the Troops

• DOI: 10.2307/3562332
• Publication Date: 2006-11-16T16:04:47Z
• Authors: Edmund G. Howe; Edward D. Martin
• Keywords: Chemical Warfare; Informed Consent; Research; Federal Government; Disclosure; Drugs, Investigational; Patient Advocacy; 06 humanities and the arts; 0603 philosophy, ethics and religion; Risk Assessment; Therapeutic Human Experimentation; United States; Gulf War; 3. Good health; Military Personnel; Social Justice; Codes of Ethics; Personal Autonomy; Government Regulation; Humans; Ethics, Medical; Professional Misconduct

Treating the Troops On 2 August 1990, Iraq invaded Kuwait. Since it was then apparent that the U.S. might engage Iraq in combat and that Iraq might use biological and chemical weaponry, the Department of Defense (DoD) explored all means by which servicepersons could be protected. Several compounds (the word compound will be used to refer to drugs and vaccines throughout this paper) were believed to be highly safe and efficacious. Yet since the safety and efficacy of the compounds considered had not been tested on human subjects exposed to biological and chemical weapontry, by definition they were classified under FDA regulations as "investigational." The compounds considered are described in general terms by the Assistant Secretary of Defense (Health Affairs) in a letter to the Assistant Secretary for Health of the Department of Health and Human Services (HHS), printed in the Federal Register, vol. 55, no. 246, 21 December 1990 at 52814-15. He states that "these are not exotic new drugs," and goes on to say that they have "well-established uses (though in contexts somewhat different from our requirements) and are believed by medical personnel in both DoD and FDA to be safe." One is a commonly used drug that would be made available in an intramuscular injection for soldiers to use in the battlefield. Another is a vaccine recognized by the Centers for Disease Control (CDC) as "the primary preventive treatment available for a particular disease." And "still another" involves a commonly used drug that would be given in a lower dosage. Although the specific compounds considered in this instance are intended to protect servicepersons from chemical and biological weapons, the ethical principles and analysis also would apply to other investigational compounds used for "treatment" purposes, such as those intended to prevent or treat endemic diseases. In this unprecedented situation, two ethical (and legal) questions were raised: Should servicepersons be given these compounds? and, if the answer was yes, Should servicepersons be given the opportunity to grant or withhold their consent, as they would if they were research subjects? After extensive review by DoD, FDAm and HHS of the available data, it was decided to give servicepersons the compounds and infrom them about the compounds' investigational status, side effects, and risks, but no to obtain their consent. The arguments believed to justify this decision are presented below. Treatment, Not Research The compounds presently in question are intended to protect servicepersons from the effects of biological and chemical weaponry. If the threat from this weaponry did not exist, the use of these compounds would not be considered. Their use is for preventive or therapeutic treatment as opposed to research. The Belmont Report to some extent addresses this situation: Although practice usually involves interventions designed solely to enhance the well-being of a perticular individual, interventions are sometimes applied to one individual for the enhancement of the well-being of another (e.g., blood donation, skin grafts, organ transplants) or an intervention may have the dual purpose of enhancing the well-being of a particular individual, and at the same time, providing some benefit to others (e.g., vaccination, which protects both the person who is vaccinated and society generally). The fact that some forms of practice have elements other than immediate benefit to the individual receiving an intervention, however, should not confuse the general distinction between research and practice. Even when a procedure applied in practice may benefit some other person, it remains an intervention designed to enhance the well-being of a particular individual or groups of individuals; thus, it is practice and need not be reviewed as research. The Declaration of Helsinki echoes the importance of this distintion: In the field of biomedical research a fundamental distinction must recognized between medical research in which the aim is essentially diagnostic or therapeutic for a patient, and medical research, the essential object of which is purely scientific and without direct diagnostic or therapeutic value to the person subjected to the research. …