Biodefense Programs Research Articles

Biodefense and the return to great-power competition

ABSTRACT The 2017 US National Security Strategy asserts that, “after being dismissed as a phenomenon of an earlier century, great power competition returned,” pointing to actions that Russia and China have taken to reassert their influence and attempt to change the international order. Such a shift has implications for biodefense. It suggests an increased likelihood of the development and potential use of biological weapons by states, which had been downplayed by those who have been more concerned about non-state biological-weapons programs. State program access to expertise, facilities, and resources implies a greater level of technological sophistication than would typically be credited to non-state actors, influencing the requirements for national biodefense programs to detect, characterize, respond, to, and attribute a biological attack. States also could have missions for biological weapons that differ from those intended by terrorists.

Confronting Public Health Imperialism: A Transnational Feminist Analysis of Critical Nurse Responses to the National Smallpox Vaccination Program of 2002

Confronting Public Health ImperialismA Transnational Feminist Analysis of Critical Nurse Responses to the National Smallpox Vaccination Program of 2002 Gwen D'Arcangelis (bio) small acts of resistance: gender and imperialism The juggernaut of US empire known as the "War on Terror" is by now a familiar, ubiquitous part of the twenty-first century. Less familiar to most is one of its early missteps, namely, the National Smallpox Vaccination Program (NSVP), a biodefense program that the Bush Administration devised to protect the US from a bioterror attack. From late 2002 to mid-2003, the federal government, arguing that a potential attack might occur from the likes of Al Qaeda or Iraq, attempted to recruit the health care field into a preemptive vaccination program against smallpox. Nurses were among the prominent occupational categories targeted, and more important, among the leading groups who challenged the program on the grounds of its health risks and role in the Iraq war. In this article I chronicle the multilayered intervention that US nurses made in the NSVP, specifically their reworking of hegemonic scientific and national security discourses. Nurse intervention into the NSVP is significant for two reasons. First, nurses reclaimed their centrality as decision makers in the NSVP, a prominent public health campaign that, as I show, exploited their labor and marginalized their medical expertise. Feminist scholars have analyzed nursing as a feminized labor domain long beset with the historical character of "women's work"—for example, low wages and devalued expertise.1 I demonstrate that nurses' defiance of the NSVP contributes significantly to a legacy of resistance to these conditions. Second, nurses challenged the NSVP based on its connection to the US program of aggression in Iraq and the War on Terror during a period of extreme "patriotism," when it was difficult to wage criticism of the US national security apparatus. Remarkably, US nurses linked their struggles for better safety and protections to a broader critique of US imperialism. In doing so, I argue, they enacted a model of transnational feminist praxis [End Page 95] wherein women in global north and imperial nations hold their governments accountable for perpetrating oppressive practices of imperialism and other forms of structural violence against less powerful nations in the global south. Transnational feminist theory builds on the intersectional analysis forwarded by feminist theorists such as Kimberle Crenshaw2 and Patricia Hill Collins,3 who analyze women's struggles through a gendered lens that considers how race, class, nation, and other socio-structural positions determine gender relations and social power. Transnational feminist theorists focus on the intersection between gender and nation, noting that women across the globe are not only connected by their commonalities but also severely divided, particularly along the axis of colonialism and imperialism. They have noted that many feminist movements in imperial countries have been insufficiently critical of their government's expansionist foreign policy and imperialist practices globally, at times even joining forces to further them. Transnational feminist scholars have criticized the US-based Feminist Majority Foundation, for instance, for aligning itself with the US government's war on Afghanistan and its paternalistic rescue mission to save Afghani women, in the process marginalizing Afghani feminists' work and leadership.4 Transnational feminist theorists espouse that women in imperial nations should attend to their complicity in the actions of their governments. In the context of the most recent bouts of US imperialism targeting Afghanistan and Iraq, transnational feminist scholars such as Chandra Mohanty have challenged global north feminists to be self-reflexive about their political praxis (politically informed theory and action): What role have US feminists who supported the Bush administration's war in the name of "rescuing" Afghan and Iraqi women played in [the] narrative of empire and imperialism? This is one of the questions we need to pose to address the politics of complicity and dissent within contemporary feminist projects.5 In addition to calling for feminists in imperial and global north nations to reexamine their role in US imperial violence, she also highlights US imperialism as a key site for transnational feminist engagement: The militarized US State and its imperial projects are thus a crucial site of feminist struggle both in terms of the violence...

Preparing for the next Zika.

Lessons from the US Biodefense program should inform international efforts to build a medical countermeasure enterprise for emerging infectious diseases.

American Biodefense: How Dangerous Ideas about Biological Weapons Shape National Security by Frank L. Smith III

Reviewed by: American Biodefense: How Dangerous Ideas about Biological Weapons Shape National Securityby Frank L. Smith III Thomas I. Faith (bio) American Biodefense: How Dangerous Ideas about Biological Weapons Shape National Security. By Frank L. Smith III. Ithaca, NY: Cornell University Press, 2014. Pp. 208. $35. Biological weapons pose a threat, both to the U.S. military and to civilians who live near potential terrorist targets, and defending against viruses is a difficult undertaking—so why has the United States not made a more effective investment in biodefense projects in the past? Frank L. Smith III provides an answer to this question in his American Biodefense: How Dangerous [End Page 495] Ideas about Biological Weapons Shape National Security. Smith identifies frames of reference that rely on kinetic weapons and stereotypes about non-kinetic weapons within the U.S. military bureaucracy, and he argues that they have resulted in poor policy decisions and systemic complacency with regard to biodefense. In the first two parts, Smith describes the history of U.S. biodefense viewed through a variety of interpretive frames. His discussions of realism, bureaucratic interests, and organizational frames are contextualized with an overview of biodefense from World War II through the Iraq War. The shortsighted decision to vest biological warfare responsibilities with the Chemical Warfare Service (later the Chemical Corps), made in part because chemical warfare and biological warfare were presumed to be similar, is highlighted as an example of a decision influenced by stereotypes within U.S. military organizations about biological warfare. Smith accurately argues that institutional use of terms such as CBR (Chemical, Biological, and Radiological) or WMD (Weapons of Mass Destruction) “glosses over extreme differences in kind,” and “incorrectly implies that knowledge about one of these phenomena equates to useful knowledge about the others” (p. 28). Smith describes the negative effects such stereotypes have had on the progress of scientific research, and how misconceptions about biological weapons led to a neglect of biodefense doctrine. Time and resources were wasted on unworkable biodefense systems because of an apparently widespread belief that a release of hazardous biological agents could quickly be detected in the same manner as chemical agents. The reality, Smith writes, is that “it is difficult to detect biological attacks until after the victims have already been exposed, by which time it is too late for physical protection to provide effective cover” (p. 7). Misconceptions about the availability and production cycle of vaccines led the Department of Defense to rely on a single aging thoroughbred at the University of Minnesota Medical School, named First Flight, for its entire supply of botulinum antitoxin in the decade that preceded the Gulf War. American Biodefensereviews the missteps that led to the failure to deploy adequate medical countermeasures to soldiers serving in the Persian Gulf, who could have potentially encountered biological weapons and been injured or killed as a result. Its final chapter describes the emergence of civilian biodefense—an ironic development given that “biological weapons and biodefense were widely regarded as military issues throughout the Cold War” (p. 102). Historians of military technology will enjoy Smith’s discussion of civilian biodefense development in the context of the long-running debate about how much control civilian researchers should exercise over scientific projects with national defense applications. Smith’s work is an overview, and it sometimes generalizes about what large, diverse institutions knew or did about biological threats. For example, [End Page 496] American Biodefenseasserts that the Department of Defense should have developed more operable biodefense programs given that “the United States was aware of the Soviet BW program throughout the Cold War” (p. 20). However, events such as the Sverdlovsk incident (which the author highlights) demonstrated how elements of the intelligence community were hindered by a lack of dependable information on Soviet biological weapons programs during the period. More than one year after the incident, members of the National Security Council and the Arms Control and Disarmament Agency remained frustrated by their inability to satisfactorily confirm that the anthrax outbreak at Sverdlovsk had been the result of prohibited biological warfare activities. Readers also should note that American Biodefensedoes not include a discussion of the defense of U.S...

Federal Funding for Health Security in FY2016.

This article assesses US government funding in 5 domains critical to strengthening health security: biodefense programs, radiological and nuclear programs, chemical programs, pandemic influenza and emerging infectious disease programs, and multiple-hazard and preparedness programs. This year's article also highlights the emergency funding appropriated in FY2015 to enable the international and domestic response to the Ebola outbreak in West Africa.

Normalization of test and evaluation of biothreat detection systems: Overcoming microbial air content fluctuations by using a standardized reagent bacterial mixture

Test and evaluation of engineered biothreat agent detection systems (“biodetectors”) are a challenging task for government agencies and industries involved in biosecurity and biodefense programs. In addition to user friendly features, biodetectors need to perform both highly sensitive and specific detection, and must not produce excessive false alerts. In fact, the atmosphere displays a number of variables such as airborne bacterial content that can interfere with the detection process, thus impeding comparative tests when carried out at different times or places. To overcome these bacterial air content fluctuations, a standardized reagent bacterial mixture (SRBM), consisting in a collection of selected cultivable environmental species that are prevalent in temperate climate bioaerosols, was designed to generate a stable, reproducible, and easy to use surrogate of bioaerosol sample. The rationale, design, and production process are reported. The results showed that 8.59; CI 95%: 8.46–8.72 log cfu distributed into vials underwent a 0.95; CI 95%: 0.65–1.26 log viability decay after dehydration and subsequent reconstitution, thus advantageously mimicking a natural bioaerosol sample which is typically composed of cultivable and uncultivable particles. Dehydrated SRBM was stable for more than 12months at 4°C and allowed the reconstitution of a dead/live cells aqueous suspension that is stable for 96h at +4°C, according to plate counts. Specific detection of a simulating biothreat agent (e.g. Bacillus atrophaeus) by immuno-magnetic or PCR assays did not display any significant loss of sensitivity, false negative or positive results in the presence of SRBM. This work provides guidance on testing and evaluating detection devices, and may contribute to the establishment of suitable standards and normalized procedures.

Awareness of Biological Warfare in Nigeria

First let me state categorically that the Republic of Nigeria is completely unprepared to detect, deter or defend against an attack utilizing bioweapons to cripple any of its critical complexes including government, among oil & gas, banking and health services. This lack of capacity of Nigeria biodefense may currently being exploited and probed by interest determined to undermine the unity of the Republic of Nigeria and attack our interest in the region. Science has the potential for creating even more effective and horrific biological weapons. The U.S government should assist Nigeria in establishing a biodefense program in Nigerian university, modeled after biodefense program at George Mason University, which would provide students with a background in the science and technology of biodefense and the specialized areas of threat assessment, on proliferation and medical and public health preparedness.

Federal Funding for Health Security in FY2015

Previous articles in this series have provided funding information for federal civilian biodefense programs and programs focused on radiological and nuclear preparedness and consequence management. This year the authors have expanded the focus of the analysis to US federal funding for health security. This article provides proposed funding amounts for FY2015, estimated amounts for FY2014, and actual amounts for FY2010 through FY2013 in 5 domains critical to health security: biodefense programs, radiological and nuclear programs, chemical programs, pandemic influenza and emerging infectious disease programs, and multiple-hazard and preparedness programs.

Awareness of Biological Warfare in Nigeria

First let me state categorically that the Republic of Nigeria is completely unprepared to detect, deter or defend against an attack utilizing bioweapons to cripple any of its critical complexes including government, among oil & gas, banking and health services. This lack of capacity of Nigeria biodefense may currently being exploited and probed by interest determined to undermine the unity of the Republic of Nigeria and attack our interest in the region. Science has the potential for creating even more effective and horrific biological weapons. The U.S government should assist Nigeria in establishing a biodefense program in Nigerian university, modeled after biodefense program at George Mason University, which would provide students with a background in the science and technology of biodefense and the specialized areas of threat assessment, on proliferation and medical and public health preparedness.

High-Throughput Screening of a Diversity Collection Using Biodefense Category A and B Priority Pathogens

One of the objectives of the National Institutes of Allergy and Infectious Diseases (NIAID) Biodefense Program is to identify or develop broad-spectrum antimicrobials for use against bioterrorism pathogens and emerging infectious agents. As a part of that program, our institution has screened the 10 000-compound MyriaScreen Diversity Collection of high-purity druglike compounds against three NIAID category A and one category B priority pathogens in an effort to identify potential compound classes for further drug development. The effective use of a Clinical and Laboratory Standards Institute–based high-throughput screening (HTS) 96-well–based format allowed for the identification of 49 compounds that had in vitro activity against all four pathogens with minimum inhibitory concentration values of ≤16 µg/mL. Adaptation of the HTS process was necessary to conduct the work in higher-level containment, in this case, biosafety level 3. Examination of chemical scaffolds shared by some of the 49 compounds and assessment of available chemical databases indicates that several may represent broad-spectrum antimicrobials whose activity is based on novel mechanisms of action.

Advanced Development of the rF1V and rBV A/B Vaccines: Progress and Challenges

The development of vaccines for microorganisms and bacterial toxins with the potential to be used as biowarfare and bioterrorism agents is an important component of the US biodefense program. DVC is developing two vaccines, one against inhalational exposure to botulinum neurotoxins A1 and B1 and a second for Yersinia pestis, with the ultimate goal of licensure by the FDA under the Animal Rule. Progress has been made in all technical areas, including manufacturing, nonclinical, and clinical development and testing of the vaccines, and in assay development. The current status of development of these vaccines, and remaining challenges are described in this chapter.

PREVENTING MISUSE OF THE LIFE SCIENCES

The scope of the Biological Weapons Convention (BWC) is sufficiently broad to deal with new threats emerging from developments in the life sciences; however, more thought still needs to be given to updating and improving measures to encourage biodefense-related information sharing and transparency between states. Biodefense is and has been at the core of the BWC, but the threat of bioterrorism should not distract BWC state parties or cause them to disregard the risk that illicit state-run bioweapons programs will utilize new advances in the life sciences. More states are pursuing biodefense programs—and spending more on such programs. The BWC community must address the issue of how states and civil society observers can determine the point at which a biodefense program, or parts of it, could be secretly transformed into an offensive bioweapons program. The authors propose several measures for increasing the transparency of biodefense programs, including: national oversight, confidence-building measures, mandatory codes of practice, confidence-building visits, and an international mechanism to encourage and protect whistleblowers. The authors conclude that unless accountability and transparency in biodefense programs can be attained within the next five years, the BWC will lose its relevance.

Effects of terbium chelate structure on dipicolinate ligation and the detection of Bacillus spores

Terbium-sensitized luminescence and its applicability towards the detection of Bacillus spores such as anthrax are of significant interest to research in biodefense and medical diagnostics. Accordingly, we have measured the effects of terbium chelation upon the parameters associated with dipicolinate ligation and spore detection. Namely, the dissociation constants, intrinsic brightness, luminescent lifetimes, and biological stabilities for several Tb(chelate)(dipicolinate) x complexes were determined using linear, cyclic, and aromatic chelators of differing structure and coordination number. This included the chelator array of NTA, BisTris, EGTA, EDTA, BAPTA, DO2A, DTPA, DO3A, and DOTA (respectively, 2,2′,2″-nitrilotriacetic acid; 2,2-bis(hydroxymethyl)-2,2′,2″-nitrilotriethanol; ethylene glycol-bis(2-aminoethyl ether)-N,N,N′,N′-tetraacetic acid; ethylenediamine-N,N,N′,N′-tetraacetic acid; 1,2-bis(2-aminophenoxy)ethane-N,N,N′,N′-tetraacetic acid; 1,4,7,10-tetraazacyclododecane-1,7-diacetic acid; diethylenetriamine-N,N,N′,N″,N″-pentaacetic acid; 1,4,7,10-tetraazacyclododecane-1,4,7-triacetic acid; and 1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid). Our study has revealed that the thermodynamic and temporal emission stabilities of the Tb(chelate)(dipicolinate) x complexes are directly related to chelate rigidity and a ligand stoichiometry of x = 1, and that chelators possessing either aromaticity or low coordination numbers are destabilizing to the complexes when in extracts of an extremotolerant Bacillus spore. Together, our results demonstrate that both Tb(EDTA) and Tb(DO2A) are chemically and biochemically stable and thus applicable as respectively low and high-cost luminescent reporters for spore detection, and thereby of significance to institutions with developing biodefense programs.

BIODEFENSE AND TRANSPARENCY

This article assesses, via analysis of two case studies, the relationship between the dual-use nature of biological research and negative perceptions of the US biodefense program. The primary case study is the controversy over the National Emerging Infectious Diseases Laboratories, an as-yet-unopened maximum-containment biodefense facility in Boston that some locals suspect will be used for illegal offensive biological weapons (BW) work. Lessons from this controversy are considered in the international context via a second case study: the Cold War-era Soviet bioweapons program, which was continued in part due to the Soviet belief that the US biodefense program was really a cover for offensive BW work. The two case studies demonstrate that misperceptions of US biodefense can have serious consequences that may threaten US national security. Underlying such misperceptions is the unavoidable dilemma of dual-use—legitimate peaceful research and technologies can overlap with offensive military activities. Politics play a critical role in determining outsiders’ interpretations of the intent of US biodefense activities, transforming the dual-use dilemma from a descriptive concept into a problem in which misperceptions can be highly damaging. Taking into account the important role of political relations, the article argues that negative perceptions of the US biodefense program should not be simply accepted as a fait accompli, intrinsic to the dual-use nature of the life sciences, but rather that they can and should be addressed. The article identifies greater transparency measures as crucial to doing this.

The Biological Weapons Convention and the Democratization of Mass Violence

The global governance regime to address the vast dangers of intentionally inflicted disease is ineffectively adaptive to meet emerging challenges. Scientific advances pertaining to manipulation of disease offer profound benefits but also open ominous new capacities for violence. Weaponized disease can transform a few malevolent actors wholly lacking in power from purveyors of localized death into architects of existential crises endangering international security. The historically inexorable relationship between political-economic power and technology for mass violence is shifting – a paradigm shift called the democratization of mass violence. The 7th Review Conference of the Biological Weapons Convention in December could set markers for how the world should address this paradigm shift. Three sets of global policies could reduce dangers of intentionally inflicted disease and promote bioscience’s advance while elevating global attention to public health: (1) worldwide implementation of harmonized measures to secure and account for especially dangerous pathogens and to enable interruption of intentional biothreats; (2) strengthened national reporting obligations and international investigations of suspicious behavior in order to build mutual confidence about national biodefense programs; and (3) implementation of harmonized measures to improve disease surveillance, strengthen resilience to bio-attacks and stanch an attack’s transnational spread.

ERIC–Comprehensive Bioinformatics Resources for Enteropathogens

As part of the nation's biodefense program, the National Institute of Allergy and Infectious Diseases (NIAID) created a Genomics Initiative. As one component, in 2004 NIAID awarded eight contracts for Bioinformatics Resource Centers (BRCs) for Biodefense and Emerging/Re-emerging Infectious Diseases (the full list of awardees can be viewed at www.niaid.nih.gov/dmid/genomes/brc/). These Centers were set up to promote basic research into the NIAID Category A-C pathogens, with a mission to facilitate discovery of diagnostics, vaccines, and therapeutics.

Strengthening Bioterrorism Prevention: Global Biological Materials Management

The anthrax attacks of 2001 demonstrated that bioterrorism poses a significant threat to U.S. national security. This threat is increasing as a result of the rapid expansion in scale and technical capabilities of the global biotechnology industry, which is broadening the availability of materials, technologies, and expertise needed to produce a biological weapon and is lowering the barriers to biological weapons terrorism and proliferation. At the same time, there has been a rise of sophisticated yet loosely networked transnational terrorist groups that have shown an interest in bioterrorism. The United States must confront this convergence. Although the U.S. government pursues many different biodefense programs to bolster its ability to detect and respond to a bioterrorist attack, these efforts must be augmented with preventive measures to meet today's international challenges. U.S. Homeland Security Presidential Directive 10 of April 2004 defines "Prevention and Protection" as one of the four essential pillars of the U.S. response to the bioterrorist threat. However, while bioscience and policy experts have proposed a variety of preventive initiatives, the creation of such programs has been slow and limited. Global biological materials management, which would focus on identifying and protecting those biological materials at the greatest risk of being used maliciously, is one potential solution. Such an approach would augment current U.S. biodefense efforts, provide the international community an effective means of mitigating the global threat of bioterrorism, and strengthen the international community's battle against emerging infectious disease.

United States biodefense, international law, and the problem of intent

Since the anthrax attacks of 2001 in the United States, annual U.S. government spending on biodefense programs has increased enormously. U.S. biodefense was once exclusively the domain of military agencies and was aimed principally at protecting battlefield troops against the products of state-run biological warfare programs. Today, it is engaged in and promoted by a variety of government agencies contemplating “bioterrorism,” and it is aimed principally at protecting the American civilian population. I ask if certain U.S. biodefense policies, pointedly those funding “threat assessment” projects, make biological attacks paradoxically more likely by undermining international norms against deliberately causing disease. I conclude that they do and consider the ramifications of this answer.

THE ETHICS OF BIODEFENSE

This essay reviews major areas of ethical debate with regard to biodefense, focusing on cases in which biodefense presents ethical problems that diverge from those presented by naturally-occurring outbreaks of infectious disease. It concludes with a call for ethicists to study not only the ethical issues raised in biodefense programs, but also the ethics of biodefense more generally.

United States biodefense, international law, and the problem of intent

Since the anthrax attacks of 2001 in the United States, annual U.S. government spending on biodefense programs has increased enormously. U.S. biodefense was once exclusively the domain of military agencies and was aimed principally at protecting battlefield troops against the products of state-run biological warfare programs. Today, it is engaged in and promoted by a variety of government agencies contemplating "bioterrorism," and it is aimed principally at protecting the American civilian population. I ask if certain U.S. biodefense policies, pointedly those funding "threat assessment" projects, make biological attacks paradoxically more likely by undermining international and transnational norms against deliberately causing disease. I conclude that they do and consider the ramifications of this answer.