Treating the Troops

Abstract

Treating Troops On 2 August 1990, Iraq invaded Kuwait. Since it was then apparent that U.S. might engage Iraq in combat and that Iraq might use biological and chemical weaponry, 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 safety and efficacy of 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 Assistant Secretary of Defense (Health Affairs) in a letter to Assistant Secretary for Health of Department of Health and Human Services (HHS), printed in Federal Register, vol. 55, no. 246, 21 December 1990 at 52814-15. He states that 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 battlefield. Another is a vaccine recognized by Centers for Disease Control (CDC) as the primary preventive available for a particular disease. And still involves a commonly used drug that would be given in a lower dosage. Although specific compounds considered in this instance are intended to protect servicepersons from chemical and biological weapons, 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 answer was yes, Should servicepersons be given opportunity to grant or withhold their consent, as they would if they were research subjects? After extensive review by DoD, FDAm and HHS of available data, it was decided to give servicepersons compounds and infrom them about 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 effects of biological and chemical weaponry. If threat from this weaponry did not exist, use of these compounds would not be considered. Their use is for preventive or therapeutic as opposed to research. The Belmont Report to some extent addresses this situation: Although practice usually involves interventions designed solely to enhance well-being of a perticular individual, interventions are sometimes applied to one individual for enhancement of well-being of another (e.g., blood donation, skin grafts, organ transplants) or an intervention may have dual purpose of enhancing well-being of a particular individual, and at same time, providing some benefit to others (e.g., vaccination, which protects both person who is vaccinated and society generally). The fact that some forms of practice have elements other than immediate benefit to individual receiving an intervention, however, should not confuse 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 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 importance of this distintion: In field of biomedical research a fundamental distinction must recognized between medical research in which aim is essentially diagnostic or therapeutic for a patient, and medical research, essential object of which is purely scientific and without direct diagnostic or therapeutic value to person subjected to research. …