Biosecurity and Public Health Ethics Issues Raised by Biological Threats
Abstract and Keywords
This chapter introduces ethical issues that arise in the context of biosecurity: policies and actions intended to prevent the development or emergence, or mitigate the consequences, of serious biological threats. These threats could include deliberate biological weapon attacks (bioterrorism), pandemics, emerging infectious diseases, or major laboratory accidents. The basic values that underpin these public health concerns are first introduced. Ethical issues that arise before, during, and following a biosecurity crisis are then examined, including issues of resource allocation, dual-use research, and the possibility of quarantine. Their resolution requires trade-offs among different ethical values, including utility, fairness, and liberty.
(p. 774) Introduction
The use of biological agents as a weapon of war or terror has its roots in antiquity, beginning with the use of pathogens to kill horses, which were vital resources in the age of mounted combat. The Mongols, during the siege of Caffa in 1346, purportedly pitched plague-ridden corpses over the walls of the city—attributed by some as the entry of the “black plague” into Europe (Wheelis, 2002). Contemporary concerns about bioterrorism became widespread following the discovery of letters containing Bacillus anthracis sent through the United States Postal Service in the fall of 2001, ultimately killing five of twenty-two people who were infected. The so-called “Amerithrax” attacks were decisive in pushing the threat of biological terrorism into the national security spotlight.
Events prior to the anthrax attacks also helped shape thinking and planning in the field. In 1984 a series of salad bars in The Dalles, Oregon, was laced with salmonella by the followers of Bhagwan Shree Rajneesh (later known as Osho). The cultists aimed to rig county elections by rendering potential voters too sick to turn out on Election Day. In the mid-1990s, the sarin gas attacks on the Tokyo subway by the Aum Shinrikyo cult killed twelve and injured hundreds. The cult had also attempted a series of biological attacks in the years leading up to the subway attacks, though none of these earlier efforts were successful (Danzig et al., 2012).
Concerns about bioterror are heightened by life sciences research that poses a “dual-use dilemma,” in which ostensibly beneficial scientific research has the potential to be misused by malevolent actors, including those who would use biological weapons (p. 775) (Selgelid, 2007, 36). Distinct from explicit research on bioweapons—such as the Soviet bioweapons program that worked, undetected, for decades to produce biological weapons for the former Union of Soviet Socialist Republics (USSR)—dual-use research is typically intended for beneficent purposes, such as curing disease. The possibility that twenty-first-century biotechnology could be misused has generated debate about how the benefits of biotechnology can be achieved without creating novel security threats.
For the purpose of this chapter, we define biosecurity as policies and actions intended to prevent the development or emergence, or mitigate the consequences, of serious biological threats—deliberate weapons, pandemics, emerging infectious diseases, or the result of major laboratory accidents. Much of this chapter focuses on the response of nation-states to deliberate biological threats, but the principles and issues related to those threats have substantial overlap and relevance for the broader range of biological threats and jurisdictions.
Biological attacks differ from pandemics, emerging infectious diseases, or accidents in one important ethical sense. Responses to a biological attack are governed by norms of the use of state power to defend and deter against violence by other agents (Allhoff, Evans, and Henschke, 2013; Orend, 2006), and by norms governing the use of state power to promote public health (Diekema, 2008; Kass, 2004). While infectious disease events—such as the 2014–2016 Ebola virus disease outbreak—may be described in terms of their threat to security (Evans, 2016), the ethics of dealing with a biological attack is distinct as a crime or act of war, and thus straddles the domains of national security and public health (Gross, 2006).
A range of ethical frameworks is consonant with an approach to public health that accounts for domestic and national security. Some frameworks are monistic, promoting a single value—such as utility or liberty (Trotter, 2007)—above all others. Others are pluralistic, conceiving of the ethics of public health as involving a trade-off among a set of plausible moral values and principles (Childress et al., 2002; Selgelid, 2009).
We endorse the latter view; further, we take the values at stake in preparing for and responding to biological threats to be utility, fairness, and liberty. By utility, we mean the aggregate well-being of a population, including, inter alia, efficiency, economic productivity, morbidity and mortality, and happiness. We take fairness to include the distribution of goods within society, and justice considerations surrounding that distribution—equality may be good for its own sake, all things considered, but we may also owe certain kinds of goods to others, such as health care workers who put themselves at risk on behalf of others. We understand liberty to broadly account for a range of negative freedoms (including rights to freedom of movement, speech, and bodily integrity) and so-called positive freedoms to welfare and education. Autonomy is a component of liberty, albeit both negative and positive: autonomy relies on freedom from coercion or unjustified (p. 776) interference (Beauchamp and Childress, 2001), and on having sufficient options from which to choose in making decisions (Raz, 1988).
Security plays an important role in responding to major biological threats. We take security to be “promotionally valuable”: it is concerned with the promotion of utility, fairness, and liberty, and with guarding against the loss of those values (Selgelid, 2012, 36). While health security often concerns preserving lives against harm, we can also talk about the security of our institutions against injustice, or of our rights against infringement. Security is a practice (e.g., a security agency), but also a state of being (e.g., feeling secure about one’s continued well-being) (Powers and Faden, 2006). Both are significant—we need the practice of security to defend against terrorism, but we also need people to, for example, feel secure that their liberties will not be violated by either terrorists or their government (Herington, 2012).
In summary, we believe the following should guide ethical action in efforts to prevent, prepare for, and respond to major biological threats: the fundamental values of utility, fairness, and liberty, and the security of these three fundamental values. Below, we elucidate how these values might guide action and where conflicts arise between these values.
Preventing, Preparing for, and Responding to Biological Threats: Ethical Issues
We can divide ethical issues associated with biosecurity and bioterrorism, broadly, into those that occur before a crisis, those that occur during a crisis (in biological terms, when cases are present), and those that occur following a crisis after cases are resolved.
Before a Crisis
Preparation is critical in responding to acts of aggression, be they armed conflict, terrorist attacks, or criminal activity (Evans, 2014). Many factors inform the probability and potential impact of major biological threats; one that bears significantly on public health ethics is the pursuit of basic scientific research that may enable or hinder a bioterror attack. Specifically, some “dual-use” research pursued in aid of public health—research that may contribute to the development of novel vaccines against potential pandemic diseases or bioterror agents, for example—may also risk the accidental or deliberate release of a dangerous pathogen. In 2011, for example, scientists reported they had created highly pathogenic avian influenza (HPAI) H5N1 viruses that were transmissible in ferrets (Herfst et al., 2012; Imai et al., 2012), which are animal models that serve as surrogates for influenza in humans (Radigan et al., 2015). The studies generated concern that such an influenza variant could accidentally or deliberately infect and harm humans and (p. 777) cause a deadly pandemic—wild-type avian influenza has a case fatality rate of about 53 percent (Evans, Lipsitch, and Levinson, 2015; Lipsitch and Galvani, 2014; Lipsitch and Inglesby, 2014; WHO, 2017).
The conduct and dissemination of dual-use research present a conflict between the liberty of scientists to conduct their research, and the purported public health benefits of this research, on the one hand; and the security of the public’s health, on the other (Evans, 2013). Part of the tension is epistemic, because the risks and benefits that arise from the use of basic scientific research are difficult to quantify. In 2014 the US government began a deliberative process to assess the risks and benefits posed by “gain-of-function” research resulting in novel pandemic pathogens, of which the 2011 HPAI H5N1 studies are paradigm examples (NRC and IOM, 2015, 1).
While the magnitude and scope of these risks and benefits are uncertain, putative conclusions can be drawn in terms of the values at stake in dual-use research. First, the liberty of scientists is not absolute: we could envisage rare cases in which both scientific freedom and the purported benefits of research are outweighed by competing considerations. If research, for example, were reasonably expected to cause a risk of catastrophic harm in the form of a virulent and widespread disease pandemic, society should prohibit dual-use research (Evans, 2013; Selgelid, 2007).
A corollary of the above is that in cases where we can avoid the apparent dilemma between promoting public health and respecting scientific liberty, we ought to do so. For example, if research with the potential to lead to catastrophic harm could be replaced with alternative experiments that promote public health without creating additional biosecurity risks, we ought to pick this alternative over its riskier counterpart (Lipsitch and Galvani, 2014). Institutions should thus strive to fund alternate experiments that benefit public health without creating new extraordinary risks, where possible.
Beyond dilemmas posed by dual-use concerns, health security is threatened by sophisticated existing biological technologies, coupled with the ability of pandemics and emerging infectious diseases to cause widespread illness. Preparing for these scenarios requires readying resources for response to a bioterror attack—be that a local, state, national, or global community. How we ought to distribute those resources presents a series of potential conflicts between fairness and efficiency in future responses.
A Conflict between Efficiency and Substantive Justice
In an emergency such as a bioterror attack, scarce resources can be allocated according to a number of different ethical principles. Perhaps the most intuitive is distributing resources so as to maximize the expected number of lives—or, alternately, life years—saved; this may be an allocation based on prognosis of recipients of an intervention (Miller et al., 2008), or one that prioritizes the preservation of societal functioning by assigning resources such as medical countermeasures to health care workers, government officials, and operators on critical infrastructure, among others (HHS, 2005). Some have argued that a lottery is, at least in principle, the only truly fair way to assign scarce medical resources (e.g., Childress, 1970); more complex approaches to maximizing life years saved account for society’s investment in individuals (and thus not necessarily prioritizing (p. 778) infants over young children who may have already received society’s efforts in education, enculturation, and so on) (Emanuel and Wertheimer, 2006). Finally, hybrid approaches could be adopted that, for example, split efforts between life years and societal functioning.
There is no clear consensus on which of these approaches is the best. Different principles could conceivably be adopted for different resources: the Ethics Subcommittee of the Advisory Committee to the Director, Centers for Disease Control and Prevention, for example, recommended societal functioning be prioritized in case of vaccines and antivirals during pandemic influenza, as they “are predominantly used to prevent or lessen illness and thus can be useful in maintaining or restoring health for groups identified as essential for preserving the functioning of society” (CDC, 2011, 9). The group also recommended, however, that ventilators be prioritized according to a complex set of principles (including societal functioning) due to their status as “essential life-saving intervention[s]” (9).
While these principles will at times be consonant (i.e., saving life years probably also requires maintaining social functioning, at least to some degree), choosing one or a combination of principles requires trade-offs compared to other arrangements. Some of these trade-offs are a function of the conditions under which an attack occurs: allocating ventilators in a way that preserves social functioning may lead to excess deaths in cases of a bioterror attack that disproportionately targets children and the elderly, such as an attack involving the contamination of the milk supply with the botulinum toxin (Wein and Liu, 2005). Other trade-offs will arise between fairness and efficiency—the degree to which we give people a fair chance to access resources could involve a trade-off against utility, for example, if resources are not allocated to promote social function. We make no recommendation on which position ought to be favored. We do believe that the public should have systematic input into these decisions in advance of a pandemic or attack, and that, to the extent feasible, the judgments of the public should be pursued (Daugherty Biddison et al., 2014).
Conflicts between Procedural Fairness and Efficiency
Preparedness priorities are subject to reasonable disagreement, in which different parties can hold plural and conflicting values about our obligations to each other in the event of an attack or an accidental release of a virulent pathogen. Here, too, we need to ask who should be at the table when we make decisions about how to (substantively) fairly distribute pandemic preparedness resources. Many of these decisions are made at the government level using expert analysts, independent of the sphere of public deliberation. It is open question about whether this should be the case: and if the answer is “no, it shouldn’t” and we ought to engage widely with the public on issues of pandemic preparedness, who should we include?
Publicizing preparedness strategies ahead of time, when based on transparent, candid, and accountable processes involving considerable public engagement, is likely to promote public trust and a sense of accountability in any future response—both of which can be in short supply in public health emergencies. While communities can come together in emergencies, recent experiences with cases of Ebola virus disease in the United States (p. 779) demonstrate that when government engagement is either unclear or overly optimistic, a perceived betrayal of trust or loss of control can jeopardize trust in public health authorities (Kruvand, 2016).
A caveat to this kind of engagement is in cases where engagement and publicity would undermine other kinds of work to prevent a bioterror attack from happening. Given that a deliberate adversary (not nature) would drive a bioweapons attack, there may be risks in publicizing one’s preparedness strategies, depending on the specifics. At least in principle, the public health aims of a response to deliberate biological weapons use could conflict with security concerns intended to keep plans from being intentionally subverted.
During a Crisis
Our responses to a bioterror attack will have to compete, in all likelihood, with public anxiety, the realities of international politics, and the limitations of biological forensics. Disease pandemics are international events. Impulses to close borders and restrict the provision of medical aid to other communities—such as between nation-states—should be resisted. Obligations to other countries to provide access to medical countermeasures and aid are grounded in three complementary principles. First, developed countries with the means to mitigate the consequences of major biological threats—or, as some have argued, that have benefited from historical economic or political injustices (Pogge, 2008)—have a moral obligation to help countries that do not have the means to do this themselves. Second, countries that supply samples for research and manufacture of medical countermeasures—including those for defense against major biological threats such as Ebola or HPAI—may be those with little capacity to defend against these threats. Fairness, in the sense of reciprocity, obligates us to share the benefits of development with those who provide the means to defend ourselves. Finally, everyone has an interest in limiting the spread of an outbreak, whether naturally or intentionally caused. In so doing, fairness and efficiency do not conflict, as the citizens of any country have an interest in preventing an outbreak from crossing its borders.
Next, crisis communication ought to be sensitive, consistent, and transparent. In the interest of fairness, and in promoting the well-being of a community, we ought to refrain from communication that marginalizes or stigmatizes groups. Maintaining community trust, moreover, requires that consistency be maintained among different communicators, and between communication and action: when agencies and responders deviate from stated actions without justification—however well-meaning this deviation might be—community trust can be eroded. Hiding or falsifying information, particularly scientific information, can destroy trust (Kruvand, 2016; Russell, 2016).
Coercive public health measures should be deployed only when such measures are demonstrably necessary, proportionate to the expected public health gains, and are the least invasive kind of measure to achieve public health goals (both in terms of the kind of burden the measure poses and the duration of that burden). Isolation, the practice of (p. 780) confining an individual infected with a disease in order to protect the community, is a paradigm example of often justified liberty-limiting measures. For particularly serious contagious diseases that may occur in the setting of either natural disease outbreaks or deliberate biological weapon use, isolation is rarely an infringement on liberty because patients are so ill. It might be possible, however, for someone to be noncompliant while infectious, either while the person is sick (but not debilitated by sickness), or while recovering but still infectious. In this case, public health officials must weigh the liberty of the individual against community safety, and it should be seen as reasonable to confine individuals during the period in which they are capable of spreading a lethal infection.
Conversely, quarantine—the practice of detaining exposed individuals on the chance that they will develop a disease—is rarely justified. Quarantine is often ineffective and historically has led to individuals attempting to evade authorities, possibly spreading the disease further, but underground. Quarantine has also led to the undermining of public trust. With modern surveillance technologies, it is often possible in the right settings to closely monitor exposed individuals without restricting their liberty until they become symptomatic, and without risking others in the process. For example, during the 2014–2016 Ebola virus disease outbreak, Nigeria experienced twenty cases of the disease but controlled the outbreak using proactive contact tracing and self-monitoring of exposed individuals using cell phones, without the need for quarantine (Hills, 2016).
Quarantine might be permissible if the liberty violation is proportionate to the public health benefit, the action is necessary to curb the disease, the action itself is feasible (e.g., there is scientific justification regarding where to draw the lines around the proposed quarantine population), it is the least invasive measure available to definitively curb the spread of the disease, and the quarantined population is treated properly (i.e., their security, nutritional, social, and medical needs are taken care of by responsible government entities throughout the course of the quarantine). There might be an engineered pathogen, for example, whose spread is rapid, airborne, and whose clinical course is irreversible and terminal. In this case, quarantine of exposed individuals or communities might be justified, providing the above conditions were met.
During the response to major biological threats, there may be room for scientific advancement and the development and trial of novel therapeutics in response to the pathogens involved. The question of whether randomized controlled trials (RCTs) can proceed ethically in outbreak zones arose during the Ebola virus disease outbreaks (IOM, 2016), which at one point divided the community between those in favor of RCTs and those in favor of nonrandomized trials or compassionate use of interventions (see e.g., Rid, 2016). Similar discussion may be warranted in the aftermath of the use of biological weapons. Wherever and whenever feasible, a consistent response model and approach to clinical trials ought to be agreed upon ahead of time and widely implemented. If compassionate use is offered to some, while others in the same context are enrolled in RCTs as the only way to access the same medicine, this is likely to undermine public confidence.
(p. 781) If the safety and efficacy of an unlicensed product are uncertain, a tension arises between offering more people access to a drug and fewer logistical hurdles, and establishing a drug’s causal role in patient outcomes. Trials typically occur under conditions of clinical equipoise, where there is a lack of consensus among the scientific community that an intervention is more likely than not to be beneficial, or vice versa. Because of this, appeals to the benefits of wide access may be mistaken, because while patients may be better off as a result of a novel intervention, they may also be left no better off, or even worse off, than a placebo. Moreover, appeals to the benefits of RCTs based on the benefit to participants must be couched carefully. Properly conducted, an RCT gives us the fastest route to knowledge of an intervention’s benefits (or lack thereof), but ex ante claims of benefits are typically unknown (Selgelid, 2016; Burton and Loftus, 2014). As a result of this uncertainty, some have suggested that “adaptive trials” should be created that allow for changes in study design in response to new evidence of benefit or harm; this idea came to the fore during the Ebola virus disease outbreak in response to concerns about benefits to participants and access to medicines (Rid, 2016).
When trials are developed as a collaborative partnership between researchers and the community, and involve appropriate informed consent and recruitment practices (e.g., Emanuel, et al., 2004), we believe randomized clinical trials of novel therapeutics are in principle better protocols than single-arm trials—all other things being equal, we wish to avoid adding to the considerable health burden of biological disasters, and a randomized clinical trial gives us the most efficacious route to knowledge of which interventions help, and which hinder. We note, however, that responses to major biological threats can be incredibly resource-intensive and chaotic. Instigating research in the middle of such events should be approached in such a way, if at all, that it does not unduly interfere with the primary goals of a response effort.
Finally, health care workers, as professionals engaged in the promotion of the (moral) good of individual and community health, have a duty to care for the infected, even at risk to themselves (Emanuel, 1988; Evans, 2015). This duty, however, is non-absolute—it may be outweighed by particularly risky cases of disease, circumstances where a lack of resources jeopardizes health care worker safety, and excessive repeated exposure. Duty to care also invokes conditions of reciprocity: given the risks health care workers accept, we owe them protective equipment, training, and compensation for the duties they perform for society. Budgets should include “hazard pay” to reflect this added responsibility, and community engagement should be designed around providing adequate caregiving to patients in a way that shares risk.
In the course of responding to major biological threats, a tension may arise between public health and law enforcement personnel regarding procedures and priorities in responding to the health impacts of a bioterror attack, and in the prosecution of the attackers. Sample handling of dangerous pathogens has a biosafety aspect, but when samples are also potential evidence—given that all three paradigms of bioterror in the last century have been acts of domestic terrorism, and thus fall under the rubric of criminal justice—concerns of justice emerge in maintaining a chain of custody over evidence in order to ensure that potential suspects are offered a fair trial and that the criminal justice (p. 782) system can prosecute the guilty. Much of this tension may be, and has been, eliminated in communities where public health and law enforcement personnel train together.
After a Crisis
After a major biological threat occurs, or a disease outbreak has been controlled, the later stages of response and recovery take place. In these stages, communities should be assisted in terms of resources and personnel, in order to rebuild and replenish infrastructure. For reasons similar to those that justify helping communities that bear the brunt of the burden of disease during a crisis, we ought to assist in their redevelopment after a crisis—we are obligated because of their vulnerability, principles of fairness, and reciprocity. Redevelopment also serves to ameliorate secondary effects that may cause lasting damage to a community or region. Preventing additional illness or disability from further depleting a community’s resources, stopping secondary outbreaks of other disease, and stabilizing political systems in the wake of a major outbreak would increase the likelihood of long-term security and public health in those communities. This, in turn, is beneficial to other communities and countries because disease outbreaks can be fueled and driven by communities that are the weakest links.
The ethics of biosecurity are generally reflective of basic strictures of biomedical and public health ethics in other emergent scenarios. At times, additional concerns unique to the maintenance of national security may conflict with the ends of public health. How we manage this conflict is complex and will depend in part on specific circumstances, as both kinds of institutions have legitimate roles, and may at times have priority over each other. Facilitating decision-making around these issues requires legal and regulatory clarity regarding powers delineated for relevant institutions. We hope that decision-makers will make these decisions—both in planning, response, and recovery—while following the ethical principles described above.
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