Major Trends in Genomic Research and Development: Emerging Challenge to Public Health and Global Security

Shortly after I heard about the shooting at Fort hood on Wednesday, it again reminded me about the November 2009 massacre when Army Maj. Nidal Malik Hasan opened fire, killing 13 people and injuring 32. The first question that crossed my mind—is this another terrorist attack? Three days after the April 15, 2012 Boston marathon bombings, President Barack Obama travelled the city and reassure us as a nation to keep our spirit strong. The President stated “We carry on. We race. We strive. We build and we work, and we love, and we raise our kids to do the same. And we come together to celebrate life and to walk our cities and to cheer for our teams when the Sox, then Celtics, then Patriots or Bruins are champions again, to the chagrin of New York and Chicago fans”. This again assert the reality, that after the attack of 9/11 our lives will never be the same again. The increasing recognition that advances in biology is the center of current concerns about the heightened probability of genetics in facilitating the development of a new generation of biological weapons. The scientific and security communities should increase their vigilance on the misuse of genomic data and the ongoing trend of revolution on biology (Labilles, 2013b).  Advances in Genomics may have a significant impact to public health, but serious concerns have been raised about the consequences of the misapplication of this field for hostile purposes. Therefore, it is critical for the continued development of sophisticated analytic techniques to better distinguish anomalies from baseline data. Likewise, combined expertise amongst systems enhance early detection performance for detection of infectious diseases. Professor Thomas D. Cabot of Harvard University has said: “A world in which these capabilities are widely employed for hostile purposes would be a world in which the very nature of conflict had radically changed.” Labilles (2013c), we need to be aware of the implications of programs such as the Free Trade Agreement (FTA), and the need of strict surveillance of the methods and what is being traded between boundaries” (para.3). Our understanding of the brain and human behavior is reaching the point at which precise manipulation for beneficial reasons is clearly feasible. The information presently available has become widely used for military purposes, and there will be knowledge available for misuse, and there will be some willing to misuse it. The line of differentiation between chemical and biological weapons is getting thinner as the genomics revolution continuous.  An individual intentionally infected by Variola major and cross the border will be a deadly moving biologic weapon. This will cause high mortality, public panic and social disruption (Labilles, 2013b, p. 2). The terrorists’ main goal is always to challenge Americans’ sense of safety and confidence, a small chemical, biological, radiological, or nuclear (CBRN) attack could be successful.

According to Richard (2000), highest estimates of the Central Intelligence Agency (CIA) indicate that as many as 100,000 people may be trafficked into the U.S. each year. Modified traditional agents targeted at specific physiological processes can be carried or injected to any individuals estimated to be trafficked into the United States annually. The office of transnational Issues of the US CIA issued a bleak warning in the late 2003 about the future of biological weapons. The report, titled The Darker Bioweapons Future, argued “growing understanding of the complex biochemical pathways that underlie life processes have the potential to enable a class of new, more virulent biological agents engineered to attack distinct biochemical pathways and elicit specific effects” (Wheelis & Dando, 2005).  The report cited of specific examples of new biological weapons and noted about the effects of some of these engineered biological agents could be worse than any disease known to man.

The CIA estimated prevalence of human trafficking vary widely both by year and by the source, with no particular trend (Hopper, 2004, p. 125). A free and open society like the U.S. will always be tested by people who hated the kind of freedom we inherited from our founding fathers. While lethal chemicals are easy to acquire, getting large quantities, and weaponizing are difficult; biological agents can be acquired in nature or from medical supply houses. Like cyberthreats, biothreats are relatively inexpensive compared to explosive, nuclear, and chemical weapons. Both cyber and biothreats can replicate themselves and spread again in their respective cyber and physical borders (Rosen, 2011). To improve psychological profiling of terrorist groups and to develop better theories regarding the roots of terrorism, the need of scientific methodology application must be recognized. It is essential to be informed on the four biosecurity trends in order to avert the concept of militarization of biology, and focus on the potential for hostile manipulation of the human nervous system.

1. Chemical, biological, and the manipulation and misuse of Emerging Infectious Disease: There is an unequivocal distinction between terrorism with chemical and biological (CB) materials, and terrorism with chemical and biological weapons. Rosen & Lucey (2001): Terrorism with CB materials deals with the use of any toxic substance or pathogen in pursuit of certain goals. Terrorism with CB weapons refers to the use of warfare agent that is a toxic chemical designed, developed and selected by the military to support specific missions laid out in the military doctrine of a state. This distinction highlights the deeper significance of the 1995 sarin attack in the Tokyo underground: for the first time a terrorist organization turned to a warfare agent (p. 172). Unknown potential threats of the emergence of dual-use technologies such as synthetic biology and nanotechnology pose additional security and containment challenges.  Nanoscale-manipulated biological agents evading current detection capabilities and the unpredictable dissemination patterns of synthetic microorganisms is a major challenge. As a proactive posture to a rapidly changing global environment, the US National Strategy for Countering Biological Threats is emphasizing prevention while continuing to support the national preparedness goals and response/recovery capabilities. The study Perkins & Nordmann (2012) aim to enhance the collective capability of the United States and the international community to address emerging health security threats. The study emphasized the need to increase our knowledge of health effects of various types of nanomaterials, and how to assess, control, and prevent harmful exposure, taking into consideration the numerous gaps that currently exist with regard to the distinct behavior of nanoparticles compared to the same chemical or material at “macro-scale”.
2. Mass-casualty Terrorism: A large scale bio-terrorist (BT) disaster would create a public health disaster in which the number of victims would exceed existing health care resources. It is an intentional disaster with the objective of causing fear, illness and death. The study of the Committee on Research and Development for improving Civilian Medical Response to Chemical and Biological Terrorism Incidents—suggest that in most cases, the United States will have some or little capability for BT mass casualty management, and triage at four levels of medical care. The four levels of medical care are local responders, initial treatment facilities, state, and federal. At the time of the study, existing conventional management and triage protocols for disasters is not fit for casualty management needs for a large-scale BT event. The three phases of management and triage process after BT event are discovery phase, epidemiological analysis phase, and lateral decision-making/triage management phase. The discovery phase of a BT event will most likely occur in an emergency department, doctor’s office or clinic (Burkle, 2002). Assumptions about the nature of the event will initially guide triage and management during the discovery phase. Syndromic surveillance is an essential component of the discovery phase base on signs and symptoms and supporting public health information. The early clinical manifestations of disease caused by most BT agents could be non-specific, or certain syndromes would be a characteristic of a potential BT attacks. Awareness of these syndromes by practitioners is significant to early discovery of an exposure. The syndromic events are a perfect determinant for surveillance to control the spread of an infectious pathogen. Agent-based models (ABM) can be used to establish structured epidemiological description of a population or infected individuals and local interaction. Agent-based Model (ABM) algorithm allows one to keep the number of active (Exposed and Infectious) agents low at the beginning of the epidemic process and thus decreases the computational burden. As the number of activated agents increases, and increases the amount of required computational resources. Using ABM, an individual is considered to be in one of the following four states: (1) Susceptible (can contract the disease given the contact with an infected individual), (2) Exposed (contracted the diseases, but is in a latent state without showing symptoms), (3) Infectious (showing symptoms and capable of infecting others), and (4) Recovered (obtained permanent immunity and cannot infect others). When an infected individual passes infection to a Susceptible individual, a corresponding susceptible agent is activated (Bobashev et al., 2007). Epidemiological analysis phase is of paramount importance in recognition of an epidemic caused by terrorism. An epidemiological investigation must occur in tandem with case definition development, once an abnormality is evident, whether it is a single or unexplained disease cluster, or mass illness event. The visual representation of a quantitative evaluation using epidemic curves will be initially useful to obtain answers to questions concerning origin, propagation, incidence, prevalence and modes of transmission. Details on unique characteristics of the BT agent can also be achieved through curve analysis. In this phase, mathematical models of disease is also essential to link the biological process of transmission and the emergent dynamics of infection at the population level. At the minimum, a team effort is significantly will dictate the success of lateral decision-making/triage management phase. Emergency managers (local and FEMA), Department of Justice (FBI), political authorities (mayor, governor), technical experts, tactical field scientists with expertise in epidemiology and infectious disease) will make up the lateral decision making at the local level. At the hospital level, the triage officer will be composed of pharmacists, infectious disease specialists, administrators, pulmonary care technicians and auxiliary hospital personnel.
3. Gross Violations of the Biological and Toxin Weapons Convention (BTWC):  The 1972 Biological and Toxin Weapons Convention was formed as a result of the end of the Cold War and the first Gulf War. The gross violations of BTWC is of great concern, and had been violated for the two decades following its entry into force that led to a six year international negotiations of a compliance protocol. A number of BTWC signatories are suspected to be involved in illegal activities. President George W. Bush withdrew from these negotiations in 2001 and has declared BWC to be “inherently unverifiable”.

Dramatic Advances in Biotechnology: In 1999, the biotechnology industry in the United States doubled in size, and its globalization is being driven not only by national decisions, but also by biotechnology firms. Growing apace in the knowledge and techniques in genomics, and genetics, giving scientists the ability to locate specific genes and identify their associated genes through genetic sequencing. Bio-informatics have supported the collection and dissemination of vast quantities of data, making it easier for knowledge and technology to be misused. Growing international subcontracting, transfer of knowledge to other entity could be the first probable breach enabling terrorists to develop new forms of bioengineered weapons to augment or replace existing capabilities. Detection, mitigation and remediation from exposure to agent strains could become much more difficult if they were modified to hide telltale signatures (Rappert, 2003). In the mid-1990, Russian scientists made detection tests for anthrax ineffective through genetic engineering techniques.  The impact of biotechnology on the threat of biological warfare is graphically represented in figure 1 (Petro et al., 2003, p. 163). The graphical representation of figure 1 depicts the timeline of relative threat level presented by traditional, genetically modified traditional and advanced biological agents. Dramatic advances in biotechnology will lead to a new class of advanced biological warfare (ABW) agents developed to bring forth novel effects. Biological research will bring new agents and delivery system that will provide a multiplicity of new options, expanding the paradigm of biological warfare.The implications of these four trends led to a re-conceptualization of the bio-terrorist threat away from misplaced analogies to nuclear or chemical weapons, and towards placing the threat in the context of the public health measures needed to combat disease (Chyba & Greninger, 2004).

Contributing Factors

The individual, interpersonal and environmental contributing factors that open the probability of biological and chemical threats could be trace to the lack of verification measures and the widespread availability of the general materials, equipment and biological knowledge necessary for weapons development. BTWC has no criteria to differentiate offensive from defensive development, production or stockpiling activities. Unless otherwise justifiable, all biological agents and toxins are banned, but it has long been a cause of concern of reported violation of BTWC by some member State Parties and countries. It has been a topic of much debate about the feasibility that individuals, sub-state groups, terrorists the capacity to develop bio-weapons. A genetically engineered infectious agent could have a probable effective means of systematic dispersal by trafficking an individual physically carrying a deadly agent or infected with deadlier viral strain that rapidly spread to a target population. With existing knowledge and technology, studies shows that terrorists or anyone can make biological weapons without obtaining a natural virus. American scientists Jeronimo Cello and colleagues at the State University of New York at Stony Brook synthesized a polio genome from scratch by stringing together commercially available strands ofDNA purchased over the Internet in accordance with the map of the RNA polio genome, which is published onthe Internet (Selgelid, 2007). Through gene splicing, the survivability of a bacterium across a range of environmental conditions could be improved. The ease to conceal legitimate biological research further energize other countries, and terrorist organizations to continue to pursue biological warfare.

Prevention

The theoretical framework of emerging biotechnologies will lead to the development of new biological agents. Technologies developed across multiple disciplines in the biological sciences will have a profound global impact and concurrently have the potential to revolutionize biological warfare by facilitating an entirely new class of fully engineered agents referred to as advanced biological warfare (ABW) agents (Petro et al., 2003). The Biological Weapons and Toxins Convention (BWTC) have done little to prevent foreign bio-weapon programs. Compounded by the possibility of terrorist organizations’ intention or capability to acquire bio-weapons—bioterror threat represents a significant challenge to our leaders, and agencies responsible for directing biodefense efforts. Prevention will be dependent upon counter proliferation, environmental detection, and medical countermeasures. The aim of the creation of a national biodefense strategy is to focus largely on addressing existing threats posed by a select group of naturally occurring pathogens and toxins. Petro et al. noted that agents traditionally associated with biological warfare likely will remain the predominant threat over the next 10 years. The implications of current and emerging biotechnologies on development of new biological agents should be considered and factored into any long term biodefense strategy (p. 161).

Public Health Policy Implications

 Dual-use research that can be used for both good and harmful purposes is plagued with ethical challenge and debates on the needs of relevant policy developments. The growing debate on “the dual-use dilemma” in life sciences research stressed the essential need of safety and security guidelines on biosecurity. Life sciences community and the security community share the common goal of protecting our Nation’s human, animal, plant and environmental health. These communities recognize this inherent tension between the need to protect the conduct of biological research from unnecessary restrictions, and mitigate potential threats to the greatest extent possible. I believe that a comprehensive review of U.S. terrorism policy, organizational structure, and preparedness are essential to respond with the shifting nature of biological research impacting existing offensive capability, and scientific advances that will be more available and applicable over the next 5 to 25 years. The National Research Council (NRC) recommended the increased education of the scientific community about the dual-use dilemma. The recommendations include that the significance of the role of institutional biosafety committees. The expanded role of institutional biosafety committees must include the function to review of research proposals for dual-use risks including environmental dangers. NRC recommendations also include self-governance of the scientific community as opposed to governmental censorship in matters related to publication of dual-use research findings.  The National Science Advisory Board for Biosecurity (NSABB) was established to provide guidance to the government regarding the oversight of dual-use research. The public health community, law and policymakers, and society in general need to address a series of critical choices (Hodge Jr., 2002). The critical and most important choice are not to decide where the power to protect the health public lies or which level of government has the primary power to act, but to decide the center of leadership during a bioterrorism event.

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Figure 1