Utility

Like any prophylaxis, there needs to be a careful analysis of the balance of risks and benefits of either taking or not taking LOB-ITs. In the context of trauma, this analysis will have to take account of the likelihood, severity and timing of injury, the efficacy of the prophylaxis, any adverse effects, and any possible impact of prophylaxis on risk-taking behaviour. LOB-IT is a new concept and currently has no direct data to inform our understanding of the magnitude of risks and benefits of the equation. While significant historical and preclinical data are available, the principle of ‘Parameters of Use’ (table 2) demands that clinical trials will be required to establish safety and efficacy. Such trials would need to conform to the accepted ethical frameworks for clinical research. These are summarised in table 3.

Accountability and responsibility

Even if type 1 LOB-ITs are to be considered ethically equivalent to other forms of prophylaxis, they still raise ethical issues in relation to acceptability and corporate responsibility. Prophylaxis in the military has not been without controversy, with widely publicised debate surrounding biological and chemical weapon prophylaxis in the first Gulf War, as well as more recent criticism of the choice of antimalarial prophylaxis agents.7–9 Controversies such as these have the potential to erode trust in military medical prophylaxis despite little evidence of harm attributable to these prophylaxes. Thus, if LOB-ITs are going to be acceptable for use, it will not be sufficient to ensure safe, open and ethical trials; it will also be necessary to consult potential user groups about the very idea of LOB-IT in advance of such trials.

One may ask whether LOB-IT is solely a military medical issue. The answer is that the population LOB-IT is most likely to benefit is that of the military because this population has a high and a potentially predictable risk profile. Even within the military, there are only particular subpopulations and activities that would confer a sufficiently high level of risk to justify the administration of LOB-IT. Thus, given that the population at risk is a military one, special ethical considerations of military medicine also apply.

Special military considerations

One of the key ethical challenges in military medicine is the balance between respect for individual autonomy and well-being, and the achievement of military objectives. Medical interventions have a special ethical status both in civilian and military settings. To illustrate this special status one can compare the ethics of non-medical versus medical protection. In the UK armed forces, combatants are ordered to wear personal protective equipment (PPE) such as body armour and hearing protection despite theoretical risks of heat injury or reduced situational awareness, respectively. Ordering individual combatants to wear PPE is justified because the benefits (protection from ballistic wounding and noise-induced hearing loss, respectively) outweigh the risks. Moreover, an injured individual may affect operational effectiveness of the entire formation. Medical prophylaxis, however, is not regarded in the same way. If combatants decline to take prophylaxis, there may be adverse consequences of so doing such as exclusion from military operations in endemic areas, and they may face sanctions (from the non-medical chain of command) for deliberately rendering themselves unfit for duty. One difference in approach to compulsion is that medical prophylaxis is prescribed by doctors, who have to adhere to their professional code of conduct as well as to military codes (previously described as ‘dual-loyalty’10). The former prohibits coercive treatment in most circumstances partly out of respect for individual patient autonomy and partly to protect individual doctor–patient relationships. Public health may be an exception to this general rule. Here the interests of the population may over-ride those of the individual. The state can legislate to provide prophylaxis to entire populations, for example, fluoridation in water and folic acid in bread, although unlike vaccinations — which are compulsory in some jurisdictions — these measures are not prescribed or administered by doctors/healthcare professionals. Furthermore, even when individuals cannot be forced to receive treatment in their own interests, they can face compulsory quarantine in the interests of the population.

The military forms a particular community within the general population and operates to different norms. In most NATO-allied nations, the decision to join the armed forces is a prima facie voluntary one. Its voluntariness has, however, been questioned. The socioeconomic and race structure of, particularly, the US military, a paucity of other job opportunities in generally disadvantaged groups, and opportunities such as free/subsidised education and free/subsidised medical care provided to family members of serving personnel may result in some economic coercion to join the military.11 Enlistment is, however, undertaken in the knowledge that it entails a significant reduction in self-determination (eg, the requirement to wear a uniform, loss of privacy, obedience to the chain of command including to being placed in harm’s way). In addition, other values gain heightened significance. In the British Army, for example, these are institutionalised as ‘The Army’s Core Values’: courage, discipline, respect for others, integrity, loyalty and selfless commitment.12 Adherence to these values, when combined with some loss of self-determination, may impact on the way that decisions are made in terms of consent and cooperation with large-scale prophylaxis programmes, including potential LOB-ITs. The emphasis on selflessness and loyalty may mean that military personnel are more likely to feel a moral obligation to agree to being exposed to LOB-ITs, even if there were no obvious gains for the individual. Furthermore, practising courage and integrity may lead military personnel to consider adherence to prophylaxis guidelines one of their duties, even if those interventions have uncertain efficacy. These factors, the voluntariness or otherwise of the decision to join the military, a reduction in self-determination of soldiers and adherence to institutionalised values, may vary from military to military, and indeed between individuals in the same military, and should be taken into account when developing novel medical interventions.

The interplay between wider social norms and rights and those governing military service is therefore a complex one. Drugs prescribed and ingested during ‘on-duty’ periods will continue to have effects during ‘off-duty’ periods (and may have lifelong consequences), as indeed may the regimens of physical exercise. Military medical professionals are both subject to the military chain of command and are required by their professional regulatory bodies to adhere to professional codes of conduct whenever and wherever they are practising. The tension that this creates for practitioners is well known, with some arguing that doctors’ professional ethics pertain even when they practise in the military environment, while others assert that the military context calls for a fundamental reunderstanding of military medical ethics.10 13

Military organisations make considerable investments in their medical services, especially those that address immediate combat injuries. In addition, heroic efforts may be made to retrieve and evacuate injured personnel, putting further lives at risk. However, despite these significant financial and manpower commitments, medical resources may be limited for reasons of operational necessity. An injured combatant may use resources that will not then be available for the next casualty, and these implications merit consideration in the military setting, as we will now discuss. Civilian patients are not normally expected to consider the interests that other patients might have in the resources necessary to treat them. This does not, however, mean that patients do not have responsibilities to protect themselves against adverse health events and to limit demands on health services.14 These responsibilities may be heightened when the costs and benefits of resources are shared not impersonally between fellow citizens, but between close friends or family members. Consider, for instance, live kidney donation by parents to their children where parents willingly undertake burdens and risks to their health to benefit that of their child. Combatants share a special relationship that may be closer to that of family members than that of a group of strangers. Moreover, in combat scenarios the uninjured survival of each member of the group adds to the chances of survival of the whole group. Each member of the group has a vested interest in being uninjured themselves and in their fellow members being uninjured. Measures that lessen the chances or impact of injury are, therefore, arguably in the interests of all. Respect for autonomy may justify affording individuals the freedom to take risks that affect only themselves. It is less clear that individuals should be similarly free to do as they wish when it comes to taking risks that have negative consequences for others. Consideration going forward, therefore, needs to be given to whether individual combatants at particularly high risk could be required to take prophylaxis in these circumstances. The values and norms of the military community suggest that individuals should (or are likely to) be willing to take prophylaxis in the interests of their colleagues, but this is in part an empirical question that also requires further investigation.

Are type 1 left of bang interventions different from other forms of prophylaxis?

Two common threats that current military prophylaxis seeks to mitigate are infectious disease and chemical agent injury. Infectious disease differs because vaccines and other prophylaxis (such as for malaria) may completely prevent the disease from occurring in the first place. In contrast, chemical weapon prophylaxis and LOB-ITs can only reduce mortality and morbidity, not eliminate them altogether. Another difference is that infectious disease prophylaxis can confer herd immunity (where subtotal administration in a population confers protection to those who have not received the prophylaxis because the reservoirs and/or vectors of that disease are reduced), whereas other prophylaxis cannot do so. As discussed above, LOB-IT-unprotected individuals within a largely LOB-IT-protected group may still gain a survival advantage because the group may have an overall greater chance of survival. From a pragmatic standpoint, LOB-ITs have more in common with prophylaxis against chemical weapons than prophylaxis against infectious disease. Since chemical weapon prophylaxis is a currently accepted practice in the appropriate threat environment, type 1 LOB-ITs could be similarly justified.

Might trauma prophylaxis encourage more risky behaviour?

One question relating to all prophylaxis is whether or not it leads to ‘risk compensation’.15 The basis of risk compensation is that a perceived protection from risk may lead to higher risk behaviour, and thus an equal or greater overall risk to the individual (or group). In the military context this could result in individuals being more willing to take risks during combat, which could be seen as beneficial to the combat effort if this increases the likelihood of achieving the mission objective. Equally, a commander might be willing to accept greater risk to his/her troops if he/she thought that they were protected by prophylaxis. This phenomenon has been discussed in non-military contexts, particularly when relating to cycle helmet wearing and HIV prophylaxis, but high-quality evidence of a consistent effect is lacking and the relevance to the military context is unknown.16 17 In any future LOB-IT discussion or trials, attention must be given to the second-order effects, such as impact on the decision-making of the chain of command or individuals, as well as the purely medical effects.

Might enhancing interventions lead to an escalation of force?

The Geneva Convention (Chapter 4, Rule 14) stipulates that the principle of proportionality is adhered to when applying lethal force. If one side improves its defensive capability, this may, in turn, justify larger and more destructive weapons being used by the other side as a proportionate measure. The use of LOB-IT could be perceived as an escalation of defensive capability by a belligerent party, ultimately leading to a greater burden of suffering and harm than would otherwise have occurred. Whether physiological or anatomical enhancement of combatants might be used by an adversary to justify more destructive weaponry is not known and has not been discussed in military doctrine or the military medical literature. It is unlikely that LOB-IT would be so effective as to justify escalation of force by a belligerent party. However, unfounded belief about the effectiveness of enhancement could potentially lead to use of greater force than would otherwise be justified if this belief was not operating. Such an escalation in the use of force may outweigh any benefits of the LOB-IT. This further highlights the importance of discussion to establish consensus as to the threshold of what constitutes an ‘enhancement’ and what the justifiable military response to such an enhancement might be in terms of the law of armed conflict.