oxford handbook of bioethics

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The term ‘bioterrorism’ seems to have become a kind of shorthand for sowing terror through the use of other ‘unconventional’ weapons, especially chemical, nuclear, and radiological weapons, or ‘dirty bombs’. The ethical problems associated with these other threats are closely associated with those raised by biological agents. Therefore, this chapter will necessarily refer to these related potential terrorist technologies, all of them made more available to militant organizations through the spread of knowledge and material in the post-cold war era.

BI OLO G I CAL WEA P O N S AND THE ETHICS

OF HUMAN EXPER IMENTS

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Following the anthrax attacks in the fall of 2001, the US government made efforts to expedite the restocking of smallpox vaccine supplies and to develop safer and more effective medical responses to biological weapons generally. The smallpox vaccine trials in particular demonstrated that the general public is enthusiastic about volunteering for clinical trials when fears of a bioterrorism attack are widespread. Although the initial phase of the clinical research on the viability of the vaccine had taken place well before 11 September 2001, the project generated little public interest until after the anthrax attacks.

The smallpox vaccine studies were conducted mainly to determine whether vaccine derived from dilutions of stocks ‘on the shelf ’ since the 1970s could register a ‘take’ in a human being. It would have been unethical to expose a human being deliberately to smallpox in order to determine the efficacy of the vaccination. This ethical obstacle to efficacy studies in humans has been a matter of concern to governmental authorities for some years. An alternative to human efficacy testing was exemplified in July 2000, when the US Food and Drug Administration approved ciproflaxicin (Cipro) for use as post-exposure therapy for inhalational anthrax based on laboratory data, animal studies, clinical trials for other diseases, and experience with the drug in routine clinical use. This model essentially became law in 2002, when the FDA adopted the ‘animal rule’, which allows certain important therapies that could be used in the case of a terror attack to be approved based on animal rather than human efficacy testing (Moreno 2003).

Although bioethics has only recently discovered issues associated with bioterrorism (ACHRE 1996; Moreno 2003), the history of medicine and warfare is replete with examples of attempts to use disease as a weapon, even before the mechanism of bacterial infection was understood. In one famous example, blankets used by soldiers dying of smallpox during the French and Indian wars are said to have been given to Indians in the hopes of spurring an epidemic. In the twentieth century a number of governments tried to enlist medical science, including human experimentation, in an effort both to produce and to defend against biological

weapons that could create terror. Discussions of medical ethics and policy concerning such experiments took place at high governmental levels, especially following the trials of Nazi experimenters at Nuremberg, West Germany, in 1946 – 7. The imperial Japanese military pursued a massive research and development program on biological and chemical weapons in occupied Manchuria. Though thousands died, none of the scientists involved was subjected to prosecution by the American administrative authority (Moreno 2001).

During the early 1950s, while the US Department of Defense was trying to assess the utility of biological and chemical weapons, Pentagon officials determined that there was no policy governing the use of human subjects in atomic, biological, and chemical (ABC) weapons research. At the time there was suspicion that both the Soviets and the Communist Chinese were surpassing the United States and its allies in developing these technologies. Reports from the Korean War suggested that psychoactive drugs were being used on American prisoners of war in an attempt to ‘brainwash’ them into providing sensitive information or even to program them to become Communist agents. Following a highly contentious secret internal debate, in 1953 the Secretary of Defense established the Nuremberg Code as the official policy of the Department for defensive ABC warfare research, including a requirement for written consent (Moreno 2001).

One specific issue that arose repeatedly in these discussions was who would be appropriate candidates for human experiments. Military personnel were an obvious possibility, for exposure to elevated risk is part of what it is to serve in the military. On the other hand, the use of service members as ‘human guinea pigs’ seemed to be both an affront to their dignity and a threat to morale. Both positions were taken before, during, and after the Second World War. Another option was the use of long-term prisoners. Their captivity made them attractive subjects in any case, and various inducements could be employed to obtain ‘volunteers’. But the Nuremberg Nazi doctors’ trial rendered this option potentially embarrassing. Hospitalized patients were another possibility, but studies with these individuals would mainly be limited to addenda to their regular treatment (as in the case of cancer patients undergoing radiation therapy); and sick patients were not necessarily the best model for a general population, let alone for healthy young military personnel. By the early 1950s there was no entirely satisfactory solution to this problem and instead a mix of subjects was utilized, sometimes with consequences that became scandals when publicly revealed years later (Moreno 2001).

There are at least two striking aspects of this concern about human experiment policies in the allied defense establishment in the early cold war era. First, these discussions presaged the academic debate about research ethics that began in the mid-1960s following several scandals; in fact, there was virtually no conversation on these issues in the early 1950s outside the military, and even the World Medical Association’s Helsinki Declaration took until the mid-1960s to become final. Second, the effects of these early policies were, at best, modest. Although there is

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evidence that attempts were made to disseminate the conditions intended to govern human experiments funded or sponsored by national security agencies, in many instances the rules were not applied.

The US Army Inspector General reached this conclusion in 1975, following the revelations of LSD experiments on thousands of soldiers in the 1960s (Moreno 2001).

Other activities that possess characteristics of medical experiments have not been classified as such, and therefore have not been subject to informed consent requirements. One prominent example is the deployment of thousands of soldiers, sailors, and airmen to atomic bomb test shots from the late 1940s to the early 1960s. Another example, about which more was learned only in 2002, is a program of aerosolized nerve gas field tests over ships at sea and in proximity of soldiers on the ground in the late 1960s. The rationale for excluding some experimental activities from informed consent procedures is mainly the need to develop force protection methods as new threats become known. This problem has become especially salient in the war on terror, in which it is assumed that soldiers are among the most likely victims of biological or chemical attacks. In the civilian context there is an analogous justification in public health, a subject I will address in the next section.

Among the unsettled ethical issues concerning human experiments in an era of bioterrorism is whether special rules should apply to classified research studies undertaken by governments. Some would argue that there is no justification for classified human experiments, others that information must be denied to an adversary, such as which strains of a certain biological agent can and cannot be defeated by available therapy. In any event, if classified human experiments are to be undertaken as part of the war on terror, as was the case during the cold war, then ethical principles of respect for persons and beneficence appear to require both prior review by a research ethics board and informed consent on the part of potential subjects. In turn, all involved parties will require the appropriate level of security clearance so that they can receive relevant information. More difficult to implement under classified conditions will be an appeals procedure in which complaints about secret research can be reviewed.

Observational studies are another sort of human experiment that may follow a catastrophic event. These projects may be undertaken by life scientists, as in the case of the long-term study of survivors of the atomic bombs at Hiroshima and Nagasaki, or behavioral scientists, such as those who interviewed persons exposed to the collapse of the World Trade Center. Protection of potential human subjects is especially difficult because there is no confidentiality for those who have been affected by the event. They are easily identified, perhaps even named in newspaper stories or interviewed by the broadcast media. Traumatized survivors may welcome the opportunity to talk to authority figures like physicians and psychologists, but may not in the acute period appreciate the scientific rather than therapeutic purpose of the study (Fleischman and Wood 2003).

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Besides the standard requirements of prior review by a research ethics committee and informed consent there are no well-established special protections for the survivors of a terrorist event. It is not clear that any further conditions are warranted, but at the very least the visibility of victims suggests that they may be subject to repeated contacts by multiple teams of well-meaning investigators, a problem that is largely unique to this population of potential subjects.

PUBLIC HEALTH AND CIV I L LIBERT I ES

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In the fall of 2001 the deliberate contamination of letters with anthrax and their subsequent distribution through the US mail system resulted in five deaths, thousands of exposures, and hundreds of persons treated. As no one could know the extent of the threat while it unfolded, the ensuing public health crisis called attention to what many regarded as weaknesses not only in bioterrorism preparedness but also in the legal framework that empowers public health authorities to act in an emergency.

In response to a request by the federal Centers for Disease Control and a number of national organizations, a group of public health law scholars developed the Model State Emergency Health Powers Act (MSEHPA). The MSEHPA is intended to provide a comprehensive set of legal standards for the response to catastrophe while also respecting civil liberties. At the time of writing more than twenty states have adopted versions of the model act (Center for Law and the Public’s Health 2003). The ink had barely dried on the MSEHPA, however, when critics charged that its provisions represented infringements on freedoms that were unjustifiable on ethical or public health grounds.

State law is the traditional repository of public health authority, but the MSEHPA authors believed that they were inadequate, obsolete, and therefore sufficiently variable from one jurisdiction to another to hamper efficient emergency response, as such events do not respect state borders. At the time, many states did not require that a strategic plan be in place for a public health emergency or ensure that channels of communication among responsible officials in neighboring states can be kept open. As well, there was significant variation in state laws concerning surveillance for early detection of pathogens so that containment and treatment plans could be triggered. Reporting systems for dangerous potential bioterrorism agents were varied or altogether absent, nor was it legally possible in some states for public health agencies to monitor data acquired from the health system, which might provide signals of unusual disease patterns (Hodge and Gostin 2003).

These and other perceived deficiencies in the status quo were partly due to concerns about infringements on civil liberties. Adequate emergency planning and response may require such extreme actions as the seizure of property for decontamination and the imposition of medical treatment such as vaccination or

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quarantine. Individuals may be required to sacrifice some of their freedom for the common good. Yet the MSEHPA authors argued that such sacrifices both are justifiable and, with proper safeguards in place, present acceptable and temporary limits on individual rights.

The MSEHPA therefore authorizes the governor to declare a public health emergency that continues until the threat is eliminated or after thirty days, except when reinstated by the governor or annulled by the legislature or a court. An emergency is defined as an imminent threat caused by bioterrorism, or a fatal biological toxin, or a new or previously controlled infectious agent that presents a high probability of numerous deaths or disabilities. Thus action by a state’s chief executive is authorized regardless of whether the public health emergency is the result of intentional human action, as in terrorism, or not (Hodge and Gostin 2003).

The model statute also requires, within twenty-four hours, reporting by doctors of cases of disease that may be caused by infectious agents, by coroners of deaths from such diseases, by pharmacists of unusual prescription patterns, and by veterinarians of deaths of animals that may have had diseases that present potential danger to humans. Besides the cooperation with government of these various professional groups, the MSEHPA encourages data-sharing among health agencies at all levels of government, with restricted access to medical records of quarantined persons in order to protect their privacy.

Under the Act property may be seized as needed to respond to a threat once the emergency has been declared. Assets needed to eliminate infectious waste, dispose of human remains safely, or otherwise to control the situation may be procured, with just compensation to any property owners who are deprived of their use. Measures may be taken to prevent or halt exploitive commercial practices like price gouging, for scarce public health services to be rationed, and for health care providers to be pressed into service.

During the emergency persons may be asked to submit to physical examinations and vaccinations, with the alternative their quarantine or isolation. These latter measures are thought to be rarely required and then are to be governed by a ‘least restrictive’ standard, consistent with the public health goal. Except for extreme cases, health officials must obtain a court order under the MSEHPA for the imposition of physical restrictions on individuals. If individuals are restricted without such an order, they are entitled to receive information and be represented by legal counsel if they wish to challenge the order or any of the conditions of isolation (Hodge and Gostin 2003).

The model statute’s critics found it based on a post-11 September hysteria that neither improved existing public health protections nor squared with traditional civil liberties. It granted public health professionals the power to order citizens to undergo medical examinations and interventions and to force physicians and hospitals to do their bidding, all under the threat of prosecution. Such provisions, it was argued, are contrary to both constitutional law and medical ethics (Annas

2003a). They are also are said to be far too broad, applying not only to a smallpox outbreak but also to many kinds of non-emergency conditions such as the annual flu epidemic (Annas 2003b).

Critics of the MSEHPA objected particularly to its provisions for the use of force in public health emergencies. Not only has large-scale quarantine been of dubious efficacy as compared with less restrictive alternatives but it may also create difficulties with public compliance. Public trust, it is argued, is the most important factor in effective public health interventions and should not be jeopardized by overreaction. Indeed, the fall 2001 anthrax attacks resulted in demands for screening and treatment by those potentially exposed, though many believed that trust in the offered anthrax vaccine was compromised by the refusal of the Department of Health and Human Services to make a recommendation on vaccination, or on which groups should be vaccinated (Annas 2003b).

Besides objections to the model statute’s details, a more general issue is the investment of public health resources in bioterrorism preparedness rather than those more familiar sources of morbidity and mortality — current infectious diseases, chemical accidents, food-borne illness, drug and alcohol abuse — for which prevention or treatment is available but under-utilized. The rationality of this critique runs afoul of the powerful symbolism of national security as somehow transformative of what might otherwise be a straightforward allocation question.

TRIAGE IN A BIOTER ROR AT TACK

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The Napoleonic armies were the first to practice a system of sorting casualties of war in order to maximize the good for the greatest number of injured combatants. This utilitarian approach is also thought to satisfy the formal requirement of justice: equity or the treatment of similar cases similarly. Equitable treatment will vary in its detail depending on the situation, but in any case should be guided by the greater likelihood that some individuals will benefit from treatment more than others, both in quality and duration, and in the urgency of treatment.

There are at least two senses of utility operative in triage for military and civilian disasters: the medical utility already described, and social utility. The latter refers to the value for the entire fighting force of returning wounded soldiers to duty. But it may also apply to a larger sense of common good that could justify an expanded form of triage in which egalitarian principles are modified to take into account the exceptional value of certain individuals to society, such as political leaders or those with rare technical expertise. A difficulty with a broad version of social utility is that it provides little guidance for specific judgments in the event of a terrorist attack or similar catastrophic event. A narrower version that provides more guidance is combined with medical utility, namely the multiplier effect of salvaging medical personnel so that they can in turn provide medical care to others (Childress 2003).

better prepared than most to confront danger, as well as to know how to act in ways that may allow life and limb to be salvaged. But what sorts of responsibilities and risks must these individuals assume? And even the most skilled emergency worker cannot be effective without the cooperation of others. What sort of infrastructure should be in place to support the extraordinary efforts of a few?

Those who assume the responsibilities of emergency medical personnel are often supposed to be prepared to provide their services in an egalitarian fashion to all in need. Yet universal beneficence is never plausible as some distinctions must always be drawn. One basis for distinguishing between levels of obligation that is so common it is rarely questioned is that of geographic distance: it is generally thought to be acceptable to minister first to those nearby rather than those suffering far away. But virtually all of those who present themselves for emergency care are moral strangers. Yet there can be grievous social consequences to the failure to confront a distant crisis with the same degree of moral seriousness that one would a local one, even though practicalities may justify tragic choices.

After the determination of the commitment emergency workers must assess the nature of the threat following the initial incident. Security agencies in particular are in a position to support or hinder the free flow of information necessary to threat assessment. Their decision making must take into account not only the public health implications of withholding sensitive information but also the social implications if, for example, the incident has especially affected members of minority groups who may already harbor skepticism about government and health care institutions based on historic experience. Thus the broader implications of decisions by national security agencies can compromise not only threat assessment but also the public cooperation that makes emergency intervention more effective (Eckenwiler 2003).

Following threat assessment, the emergency response should follow from the advance planning, perhaps involving triage. As discussed above, in this phase the most effective response will be that which has included the broadest possible public participation, transparency, and accountability, relieving health care workers of any unfair burden of determining allocation criteria on their own.

When interventions are to be provided, health care personnel will often need to make rapid decisions on behalf of patients who are unable to consent to treatment. In these cases medical best interests can form a legitimate basis for intervening. If the injuries are such that there is no validated medical therapy, then emergency workers may find themselves in a state of equipoise, in which an innovative, albeit theoretically plausible, approach may be no less promising than the standard care. If such approaches are anticipated in the event of an emergency, they should arguably be presented to the public as part of the planning process, similar to the ‘community consultation’ requirement in advance of clinical trials in the emergency department (Eckenwiler 2003). Finally, health care workers may also be obligated to impose medical treatment or isolation on individuals who pose a threat to the public. Once again, appropriate legal and institutional structures should be in place

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so that emergency workers do not shoulder an unfair burden of responsibility for potentially controversial decisions.

We have seen that considerations of national security assume unique relevance in communicating information that has public health consequences when the source of the threat is thought to be a terrorist attack. Problems of information management arise not only in threat assessment at the outset, but also in the maintenance of conventions of privacy and confidentiality. Justifiable expectations about the privacy of health information records both honor respect for persons and also give individuals the confidence that presenting themselves for medical care will not expose them to stigmatization or other social risks. These expectations may be overridden when the implications of personal health information are relevant to actions that can preserve public health, as in the case of highly infectious disease. Arguably, considerations of national security may also justify the release of personal health information as needed, to help identify the source of an outbreak, for example. Conversely, national security authorities may determine that the health status of certain groups that would normally be available to health officials should be specially safeguarded, at least for some time (Eckenwiler 2003). Again, emergency health care personnel should not be solely responsible for interpreting the circumstances under which the release of information is desirable or not, nor should the rules under which these decisions are made be imposed upon the public without prior consultation.

Emergency physicians are accustomed to finding themselves implicitly in the position of agents of law enforcement, as when they care for individuals whose injuries may have been incurred in the course of a crime. Systematic ties to national security agencies in preparation for a terrorist attack may be viewed by some as likely to compromise the ideals of independence of medical practice and transparency of public health practice. Similarly, concentration on bioterrorism preparedness can take time away from other and arguably more pressing health initiatives in response to current rather than potential threats to public health. Particularly when contemplating extreme conditions, emergency health care personnel face unique conflicts of professional responsibility that should not be theirs to bear alone (Eckenwiler 2003).

An example of the way these conflicts can emerge is the decontamination of an individual who has been exposed to a dangerous chemical agent. Unlike bacterial or viral exposures, which generally require a longer-term response, there is a brief window of treatment for victims of a chemical attack. That window requires them to disrobe and be flushed with water. In the acute period victims may not feel terribly ill and may resist public nudity. Personal decontamination kits or even large trash bags can be slipped over the outer garments so that the individual can disrobe; in some cases underwear can be kept on. These measures require a degree of expertise and planning to avoid overt conflicts between patient autonomy and the emergency worker’s beneficence-based duties in a crisis (Trotter 2004).

ORGANIZAT I ON ETHICS

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Organizations engaged in the delivery of services or production of goods for health care purposes incur special moral obligations. These moral obligations are sharpened in the event of a dire emergency. Yet non-governmental entities, whether technically ‘for profit’ or not, have a more tenuous relationship to the public good than government agencies. What is the relationship between their social obligations and their legitimate business interests? Under extreme conditions such as those that may be associated with a bioterror attack, privately held resources like pharmaceuticals or the time and skills of physicians that are normally strictly controlled by corporate interests could be needed for the public good (Mills and Werhane 2003).

A standard approach to the obligations of business entities is stakeholder theory, which states that corporate moral obligations are determined by the direct interests of shareholders. Yet a strict construal of stakeholder theory sanctions highly profitable products like child pornography that exploit the vulnerable and corrupt social life. Surely the narrow construction is unacceptable. Further, in the case of health care-related services and products, and especially in emergent circumstances, the stakeholders must be construed more broadly as including health care consumers. This broadened view of corporate stakeholders is incompatible with the notion that profit is the sole end of a business, but compatible with the view that profit is, and under ordinary conditions must be, an appropriate goal of business activity.

When extraordinary conditions prevail, then, private interests may be required to serve pressing social needs. Drug manufacturers, for example, should plan for special pricing strategies in the event of a widespread public health threat, a prudent step in any case as they risk losing control over a product if government chooses to assert its prerogatives for the greater good and withdraw patent protection. Similarly, although proprietary interests concerning sensitive product information should be protected, secrecy practices may extend beyond necessity and impinge on the public’s need to know. Industry-wide secrecy standards could eliminate concerns about competitive advantage while preserving the free flow of socially valuable information (DeRenzo 2003).

Corporations engaged in the production and distribution of substances that could be turned to terrorist advantage also have an obligation to put adequate security measures in place and to provide educational programs for their employees. Cooperation with local, regional, and, depending on the nature of the business, even national authorities may be required, especially if the company’s facilities could be directly exploited and toxic substances released (DeRenzo 2003).