Publications

On Monday, the World Health Organization (WHO) declared the Zika virus a public health emergency of international concern, with the potential to infect up to four million people in the Americas by year’s end. Under increasing pressure to slow the spread of the disease, the Brazilian government has stepped up its response, including mobilizing 220,000 military personnel to cities across the country.

Synthetic biology is an emerging technical field that aims to make biology easier to engineer; the field has applications in strategically important sectors for the US economy. While the United States currently leads in synthetic biology R&D, other nations are heavily investing in order to boost their economies, which will inevitably diminish the US leadership position. This outcome is not entirely negative—additional investments will expand markets—but it is critical that the US government take steps to remain competitive: There are applications from which the US population and economy may benefit; there are specific applications with importance for national defense; and US technical leadership will ensure that US experts have a leading role in synthetic biology governance, regulation, and oversight. Measures to increase competitiveness in S&T generally are broadly applicable for synthetic biology and should be pursued. However, the US government will also need to take action on fundamental issues that will affect the field's development, such as countering anti-GMO (genetically modified organism) sentiments and anti-GMO legislation. The United States should maintain its regulatory approach so that it is the product that is regulated, not the method used to create a product. At the same time, the United States needs to ensure that the regulatory framework is updated so that synthetic biology products do not fall into regulatory gaps. Finally, the United States needs to pay close attention to how synthetic biology applications may be governed internationally, such as through the Nagoya Protocol of the Convention on Biological Diversity, so that beneficial applications may be realized.

Recent developments in the ongoing West African Ebola outbreak have, according to the media, prompted doctors to “tear up” everything they know. The events in question are the “relapse” of Scottish nurse Pauline Cafferkey, Dr. Ian Crozier's battle with an Ebola-caused eye infection, and the possibility of sexual transmission of the virus long after recovery.

While these phenomena are important and perhaps not widely known, they are not unprecedented and are fully consistent with known pathophysiological principles of disease. The key to understanding why these events occur—and could have been anticipated—is the concept of “sanctuary sites.”

Biosecurity risks are an increasing concern in Southeast Asia. An outbreak of infectious disease in the region, whether the result of a deliberate attack, an accidental release, or a natural occurrence, could threaten global commerce. It could also affect the security and stability of US allies and interests along the increasingly contentious South China Sea. In addition to the persistent threat of emerging diseases, porous borders and increased terrorist activity in Southeast Asia are continuing to add to this region's biosecurity concerns. In response to the growing biosecurity risks, it is important for the United States to work with partner nations in the region to build bridges of cooperation, share information, and identify practices to manage and diminish the risks posed by biological threats.

During the past few years, there has been substantial debate concerning the risks and benefits of certain experiments with pathogens—initially motivated by two publications in 2012 that described laboratory efforts to enhance the mammalian transmissibility of the avian H5N1 influenza virus. One of these two reports was particularly noteworthy because the experiments were designed to yield new viruses with a set of properties that together might confer pandemic potential, such as high transmissibility, high pathogenicity, and resistance to commonly available countermeasures. Not all research on pathogens generates such concerns; in fact, it is only a rare experiment that might lead to the creation of a novel pathogen with pandemic potential (PPP). The term “gain?of?function” has also been used to describe this realm of research, but it refers to a much broader range of widely accepted non?controversial research techniques and goals. For that reason, we think it should not be used in this discussion and refer to this work with the more precise term of PPP.

There is currently a lack of national-level norms for biosafety. Considering that a laboratory accident involving a contagious pathogen could have long-term consequences that extend beyond an individual incident into the practice of science more broadly, it is in the interests of scientists everywhere that international norms are developed.

Biosecurity risks are likely to evolve a great deal over the next 10 years, in large part as a result of two ongoing and escalating trends in the biological sciences. The first is that the field is becoming industrialized and incorporated into diverse and strategically important sectors. Petroleum, essential to the manufacture of scores of goods from plastics to paints, is being gradually replaced by biological products as the basis for myriad commodities. Biological manufacturing is now the focus of big corporations, and nations are interested in growing their bio-economies. The second trend is toward greater personalization and individual control. Ever more powerful biological techniques are increasingly accessible to individuals who use them as they see fit. As a result of both shifts, the biological sciences will become even more prevalent, and their practitioners capable of manipulating genes and organisms on a scale not possible 10 years ago.

The authors argue that clinicians, public health experts, and representatives of the public should be involved in examining the advisability of performing experiments intended to create potential pandemic pathogens, providing important perspectives on how to reduce the risks of such research, and increasing public confidence in scientists as responsible stewards.

The bombing by US military forces of a hospital in Afghanistan on October 3 has thrust the issue of respect for the laws of war into the spotlight. The attack on the medical facility run by Doctors Without Borders (also known as Médecins Sans Frontièrs, or MSF), which killed at least 22 civilians, may have violated international humanitarian law and has led to accusations by the medical charity that US military forces committed a “war crime.”

This article analyses how United Nations peacekeeping operations are harnessing geospatial technology, including high-resolution satellite imagery and geographic information systems (GIS), in the furtherance of peace and security. We argue that it is strengthening the ability of peacekeepers to accomplish their mandated tasks, including the demarcation of international boundaries, support for the negotiation of peace agreements, stabilization, the protection of civilians, human rights monitoring, electoral assistance, support for the extension of state authority and the provision of humanitarian assistance. However, it remains to be seen how and to what extent UN peacekeeping can continue to grow and expand its geospatial capabilities. We identify several challenges of an operational and political nature that tend to impede its utilization. A key question in this regard is whether politics will prevent peacekeepers from exploiting recent advances in geospatial technology. We conclude and synthesize our argument by developing a simplified framework for determining when and under what conditions peacekeepers can effectively harness geospatial technology.

Successful management of a pandemic or disaster requires implementation of preexisting plans to minimize loss of life and maintain control. Managing the expected surges in intensive care capacity requires strategic planning from a systems perspective and includes focused intensive care abilities and requirements as well as all individuals and organizations involved in hospital and regional planning. The suggestions in this article are important for all involved in a large-scale disaster or pandemic, including front-line clinicians, hospital administrators, and public health or government officials. Specifically, this article focuses on surge logistics—those elements that provide the capability to deliver mass critical care.

We thank Martin Furmanski for his interest in our article (1) concerning the unnatural origins of the 1977 H1N1 influenza virus strain. In his Letter to the Editor, he challenges our assertion that to date, there has been no real-world example of a laboratory accident that has led to a global epidemic, and he states that we ourselves concluded that the virus “originated in a microbiology laboratory and its release was unintentional,” to which he added that “which laboratory is responsible matters little in the GoF debate” (2). This is a mischaracterization of our findings.

The ongoing moratorium on gain-of-function (GOF) research with highly pathogenic avian influenza and SARS and MERS coronaviruses has drawn attention to the current debate on these research practices and the potential benefits and risks they present. While much of the discussion has been steered by members of the microbiology and policy communities, additional input from medical practitioners will be highly valuable toward developing a broadly inclusive policy that considers the relative value and harm of GOF research. This review attempts to serve as a primer on the topic for the clinical community by providing a historical context for GOF research, summarizing concerns about its risks, and surveying the medical products which it has yielded.

The U.S. government (USG) has taken steps intended to diminish the likelihood of misuse of research—in one recent action, declaring a funding moratorium on gain-of-function studies on influenza until a risk-benefit analysis can be conducted (1). The analysis is expected to examine biosafety concerns, the potential for such research to produce a biological weapons agent, and the possibility that publication may lower barriers to bioweapons development (1). To analyze the security risks of biological research, however, it is first necessary to determine the likelihood that bioweapons will threaten national security and to what degree legitimate research is at risk of misuse. This type of assessment is fraught with uncertainty.

The 1977-1978 influenza epidemic was probably not a natural event, as the genetic sequence of the virus was nearly identical to the sequences of decades-old strains. While there are several hypotheses that could explain its origin, the possibility that the 1977 epidemic resulted from a laboratory accident has recently gained popularity in discussions about the biosafety risks of gain-of-function (GOF) influenza virus research, as an argument for why this research should not be performed. There is now a moratorium in the United States on funding GOF research while the benefits and risks, including the potential for accident, are analyzed. Given the importance of this historical epidemic to ongoing policy debates, we revisit the evidence that the 1977 epidemic was not natural and examine three potential origins: a laboratory accident, a live-vaccine trial escape, or deliberate release as a biological weapon. Based on available evidence, the 1977 strain was indeed too closely matched to decades-old strains to likely be a natural occurrence. While the origin of the outbreak cannot be conclusively determined without additional evidence, there are very plausible alternatives to the laboratory accident hypothesis, diminishing the relevance of the 1977 experience to the modern GOF debate. 

Increasingly frequent and costly disasters in the US have prompted the need for greater collaboration at the local level among healthcare facilities, public health agencies, emergency medical services, and emergency management agencies. We conducted a multiphase, mixed-method, qualitative study to uncover the extent and quality of existing collaborations, identify what factors impede or facilitate the integration of the preparedness community, and propose measures to strengthen collaboration. Our study involved a comprehensive literature review, 55 semistructured key-informant interviews, and a working group meeting. Using thematic analysis, we identified 6 key findings that will inform the development of tools to help coalitions better assess and improve their own preparedness community integration.

This Synopsis provides summaries of key international treaties, agreements, instruments, guidelines, multilateral engagement mechanisms, and information resources intended to guide national approaches to biosafety in research, clinical, and industrial laboratories. It summarizes the benefits and limitations of each in promoting biosafety, and their individual contributions towards minimizing the global risk and consequences of laboratory accidents. Though the compilation of these arrangements, we have determined that there is an extensive array of existent governmental mechanisms related to biosafety. However, this work also exposed a major gap in international biosafety coverage related to the potential for high-consequence accidents: there remains a need for international norms for the biosafety and governance of those pathogens that have increased potential to spark a pandemic. 

Efforts by local health departments to screen recent immigrants for tuberculosis (TB) are an important component of broader TB control goals. Foreign-born individuals represent a significant source of new cases of active TB reported in the United States. In 2012, the incidence of TB was 11.5 times as great among foreign-born individuals in the United States than it was for individuals born in the United States. It has been estimated by the US Centers for Disease Control and Prevention (CDC) that 4 out of 5 active TB cases among foreign-born persons is attributable to reactivation of TB that was likely acquired prior to arrival in the United States.

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.

Leading experts have declared that the end of the age of antibiotics is imminent and that this development could undermine the foundation of much of modern medicine and public health., Since antibiotics were first introduced into clinical practice some 80 years ago, microbes have been evolving ways to resist these drugs, but in recent years this problem of antimicrobial resistance (AMR) has been rapidly getting worse.