The growing concern over the potential use of biological agents as weapons and the continuing work of the Biological Weapons Convention has promoted an interest in establishing national biological laboratory biosafety an...The growing concern over the potential use of biological agents as weapons and the continuing work of the Biological Weapons Convention has promoted an interest in establishing national biological laboratory biosafety and biosecurity monitoring programs. The challenges and issues that should be considered by governments, or organizations, embarking on the creation of a biological laboratory biosafety and biosecurity monitoring program are discussed in this article. The discussion focuses on the following questions: Is there critical infrastructure support available? What should be the program focus? Who should be monitored? Who should do the monitoring? How extensive should the monitoring be? What standards and requirements should be used? What are the consequences if a laboratory does not meet the requirements or is not willing to comply? Would the program achieve the results intended? What are the program costs? The success of a monitoring program can depend on how the government, or organization, responds to these questions.
In response to the 2009 H1N1 influenza pandemic, the governments of Japan and the United States for the first time authorized the emergency use of unapproved drugs. In this article, we comprehensively review the differen...In response to the 2009 H1N1 influenza pandemic, the governments of Japan and the United States for the first time authorized the emergency use of unapproved drugs. In this article, we comprehensively review the different regulatory approaches of Japan and the United States, countries with advanced regulatory and healthcare systems, to emergency authorization of the use of medical products as a countermeasure to public health emergencies. We outline the legal system, range of targeted products, requirements for the application dossier, legal stance for authorization, product availability, and termination of the Japanese Emergency Approval (EA), and we compare characteristics with those of the US Emergency Use Authorization (EUA). We also review the actual cases of these 2009 emergency authorizations. The Japanese EA importation of novel H1N1 influenza vaccines with adjuvant is presented, with lessons learned, and contrasted with the US EUA of peramivir.
Biosecur Bioterror
· 2012 Sep · PMID 22871221
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Dual-use research of concern (DURC) is scientific research with significant potential for generating information that could be used to harm national security, the public health, or the environment. Editors responsible fo...Dual-use research of concern (DURC) is scientific research with significant potential for generating information that could be used to harm national security, the public health, or the environment. Editors responsible for journal policies and publication decisions play a vital role in ensuring that effective safeguards exist to cope with the risks of publishing scientific research with dual-use implications. We conducted an online survey of 127 chief editors of life science journals in 27 countries to examine their attitudes toward and experience with the review and publication of dual-use research of concern. Very few editors (11) had experience with biosecurity review, and no editor in our study reported having ever refused a submission on biosecurity grounds. Most respondents (74.8%) agreed that editors have a responsibility to consider biosecurity risks during the review process, but little consensus existed among editors on how to handle specific issues in the review and publication of research with potential dual-use implications. More work is needed to establish consensus on standards for the review and publication of dual-use research of concern in life science journals.
Layshock JA, Pearson B, Crockett K
… +4 more, Brown MJ, Van Cuyk S, Daniel WB, Omberg KM
Biosecur Bioterror
· 2012 Sep · PMID 22871211
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Reaerosolization or resuspension-that is, the reintroduction of previously airborne particles into the atmosphere-is a complex phenomenon. Microbial reaerosolization is particularly poorly understood because few studies...Reaerosolization or resuspension-that is, the reintroduction of previously airborne particles into the atmosphere-is a complex phenomenon. Microbial reaerosolization is particularly poorly understood because few studies have been done in this area, and many of the studies that have been performed are not in the peer-reviewed literature. The reaerosolization of Bacillus anthracis in outdoor environments is of particular concern because of its stability and potential for use as a biological weapon. This review pulls together data from more than 30 publications, spanning field and laboratory experiments, to summarize the current state of our understanding of Bacillus spp. reaerosolization in outdoor environments.
Previous reports have identified the development of healthcare coalitions as the foundation for disaster response across the United States. This survey of acute care hospitals characterizes the current status of particip...Previous reports have identified the development of healthcare coalitions as the foundation for disaster response across the United States. This survey of acute care hospitals characterizes the current status of participation by US hospitals in healthcare coalitions for emergency preparedness planning and response. The survey results show the nearly universal nature of a coalition approach to disaster response. The results suggest a need for wide stakeholder involvement but also for flexibility in structure and organization. Based on the survey results, the authors make recommendations to guide the further development of healthcare coalitions and to improve local and national response to disasters.
Despite the tragic accidents in Fukushima and Chernobyl, the nuclear power industry will continue to contribute to the production of electric energy worldwide until there are efficient and sustainable alternative sources...Despite the tragic accidents in Fukushima and Chernobyl, the nuclear power industry will continue to contribute to the production of electric energy worldwide until there are efficient and sustainable alternative sources of energy. The Chernobyl nuclear accident, which occurred 26 years ago in the former Soviet Union, released an immense amount of radioactivity over vast territories of Belarus, Ukraine, and the Russian Federation, extending into northern Europe, and became the most severe accident in the history of the nuclear industry. This disaster was a result of numerous factors including inadequate nuclear power plant design, human errors, and violation of safety measures. The lessons learned from nuclear accidents will continue to strengthen the safety design of new reactor installations, but with more than 400 active nuclear power stations worldwide and 104 reactors in the Unites States, it is essential to reassess fundamental issues related to the Chernobyl experience as it continues to evolve. This article summarizes early and late events of the incident, the impact on thyroid health, and attempts to reduce agricultural radioactive contamination.
Kyriacou DN, Dobrez D, Parada JP
… +4 more, Steinberg JM, Kahn A, Bennett CL, Schmitt BP
Biosecur Bioterror
· 2012 Sep · PMID 22845046
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Rapid public health response to a large-scale anthrax attack would reduce overall morbidity and mortality. However, there is uncertainty about the optimal cost-effective response strategy based on timing of intervention,...Rapid public health response to a large-scale anthrax attack would reduce overall morbidity and mortality. However, there is uncertainty about the optimal cost-effective response strategy based on timing of intervention, public health resources, and critical care facilities. We conducted a decision analytic study to compare response strategies to a theoretical large-scale anthrax attack on the Chicago metropolitan area beginning either Day 2 or Day 5 after the attack. These strategies correspond to the policy options set forth by the Anthrax Modeling Working Group for population-wide responses to a large-scale anthrax attack: (1) postattack antibiotic prophylaxis, (2) postattack antibiotic prophylaxis and vaccination, (3) preattack vaccination with postattack antibiotic prophylaxis, and (4) preattack vaccination with postattack antibiotic prophylaxis and vaccination. Outcomes were measured in costs, lives saved, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). We estimated that postattack antibiotic prophylaxis of all 1,390,000 anthrax-exposed people beginning on Day 2 after attack would result in 205,835 infected victims, 35,049 fulminant victims, and 28,612 deaths. Only 6,437 (18.5%) of the fulminant victims could be saved with the existing critical care facilities in the Chicago metropolitan area. Mortality would increase to 69,136 if the response strategy began on Day 5. Including postattack vaccination with antibiotic prophylaxis of all exposed people reduces mortality and is cost-effective for both Day 2 (ICER=$182/QALY) and Day 5 (ICER=$1,088/QALY) response strategies. Increasing ICU bed availability significantly reduces mortality for all response strategies. We conclude that postattack antibiotic prophylaxis and vaccination of all exposed people is the optimal cost-effective response strategy for a large-scale anthrax attack. Our findings support the US government's plan to provide antibiotic prophylaxis and vaccination for all exposed people within 48 hours of the recognition of a large-scale anthrax attack. Future policies should consider expanding critical care capacity to allow for the rescue of more victims.
In this article, we analyze feedback from simulated casualties who took part in field exercises involving mass decontamination, to gain an understanding of how responder communication can affect people's experiences of a...In this article, we analyze feedback from simulated casualties who took part in field exercises involving mass decontamination, to gain an understanding of how responder communication can affect people's experiences of and compliance with decontamination. We analyzed questionnaire data gathered from 402 volunteers using the framework approach, to provide an insight into the public's experiences of decontamination and how these experiences are shaped by the actions of emergency responders. Factors that affected casualties' experiences of the decontamination process included the need for greater practical information and better communication from responders, and the need for privacy. Results support previous findings from small-scale incidents that involved decontamination in showing that participants wanted better communication from responders during the process of decontamination, including more practical information, and that the failure of responders to communicate effectively with members of the public led to anxiety about the decontamination process. The similarity between the findings from the exercises described in this article and previous research into real incidents involving decontamination suggests that field exercises provide a useful way to examine the effect of responder communication strategies on the public's experiences of decontamination. Future exercises should examine in more detail the effect of various communication strategies on the public's experiences of decontamination. This will facilitate the development of evidence-based communication strategies intended to reduce anxiety about decontamination and increase compliance among members of the public during real-life incidents that involve mass decontamination.
Since 2001, the United States government has spent substantial resources on preparing the nation against a bioterrorist attack. Earlier articles in this series have analyzed civilian biodefense funding by the federal gov...Since 2001, the United States government has spent substantial resources on preparing the nation against a bioterrorist attack. Earlier articles in this series have analyzed civilian biodefense funding by the federal government for fiscal years (FY) 2001 through proposed funding for FY2012. This article updates those figures with budgeted amounts for FY2013, specifically analyzing the budgets and allocations for civilian biodefense at the Departments of Health and Human Services, Defense, Homeland Security, Agriculture, Commerce, and State; the Environmental Protection Agency; and the National Science Foundation. As in previous years, our analysis indicates that the majority (>90%) of the "biodefense" programs included in the FY2013 budget have both biodefense and non-biodefense goals and applications-that is, programs to improve infectious disease research, public health and hospital preparedness, and disaster response more broadly. Programs that focus solely on biodefense represent a small proportion (<10%) of our analysis, as the federal agencies continue to prioritize all-hazards preparedness. For FY2013, the federal budget for programs focused solely on civilian biodefense totals $574.2 million, and the budget for programs with multiple goals and applications, including biodefense, is $4.96 billion, for an overall total of $5.54 billion.
Understanding the fate and transport of biological agents into buildings will be critical to recovery and restoration efforts after a biological attack in an urban area. As part of the Interagency Biological Restoration...Understanding the fate and transport of biological agents into buildings will be critical to recovery and restoration efforts after a biological attack in an urban area. As part of the Interagency Biological Restoration Demonstration (IBRD), experiments were conducted in Fairfax County, VA, to study whether a biological agent can be expected to infiltrate into buildings following a wide-area release. Bacillus thuringiensis var. kurstaki is a common organic pesticide that has been sprayed in Fairfax County for a number of years to control the gypsy moth. Because the bacterium shares many physical and biological properties with Bacillus anthracis, the results from these studies can be extrapolated to a bioterrorist release. In 2009, samples were collected from inside buildings located immediately adjacent to a spray block. A combined probabilistic and targeted sampling strategy and modeling were conducted to provide insight into likely methods of infiltration. Both the simulations and the experimental results indicate sampling entryways and heating, ventilation, and air conditioning (HVAC) filters are reasonable methods for "ruling in" a building as contaminated. Following a biological attack, this method is likely to provide significant savings in time and labor compared to more rigorous, statistically based characterization. However, this method should never be used to "rule out," or clear, a building.
Vaughan E, Tinker TL, Truman BI
… +2 more, Edelson P, Morse SS
Biosecur Bioterror
· 2012 Jun · PMID 22582813
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Recent national plans for recovery from bioterrorism acts perpetrated in densely populated urban areas acknowledge the formidable technical and social challenges of consequence management. Effective risk and crisis commu...Recent national plans for recovery from bioterrorism acts perpetrated in densely populated urban areas acknowledge the formidable technical and social challenges of consequence management. Effective risk and crisis communication is one priority to strengthen the U.S.'s response and resilience. However, several notable risk events since September 11, 2001, have revealed vulnerabilities in risk/crisis communication strategies and infrastructure of agencies responsible for protecting civilian populations. During recovery from a significant biocontamination event, 2 goals are essential: (1) effective communication of changing risk circumstances and uncertainties related to cleanup, restoration, and reoccupancy; and (2) adequate responsiveness to emerging information needs and priorities of diverse populations in high-threat, vulnerable locations. This telephone survey study explored predictors of public reactions to uncertainty communications and reassurances from leaders related to the remediation stage of an urban-based bioterrorism incident. African American and Hispanic adults (N=320) were randomly sampled from 2 ethnically and socioeconomically diverse geographic areas in New York and California assessed as high threat, high vulnerability for terrorism and other public health emergencies. Results suggest that considerable heterogeneity exists in risk perspectives and information needs within certain sociodemographic groups; that success of risk/crisis communication during recovery is likely to be uneven; that common assumptions about public responsiveness to particular risk communications need further consideration; and that communication effectiveness depends partly on preexisting values and risk perceptions and prior trust in leaders. Needed improvements in communication strategies are possible with recognition of where individuals start as a reference point for reasoning about risk information, and comprehension of how this influences subsequent interpretation of agencies' actions and communications.
Even amidst the devastation following the earthquake and tsunami in Japan that killed more than 20,000 people, it was the accident at the Fukushima Daiichi nuclear power plant that led the country's prime minister, Naoto...Even amidst the devastation following the earthquake and tsunami in Japan that killed more than 20,000 people, it was the accident at the Fukushima Daiichi nuclear power plant that led the country's prime minister, Naoto Kan, to fear for "the very existence of the Japanese nation." While accidents that result in mass radiological releases have been rare throughout the operating histories of existing nuclear power plants, the growing number of plants worldwide increases the likelihood that such releases will occur again in the future. Nuclear power is an important source of energy in the U.S. and will be for the foreseeable future. Accidents far smaller in scale than the one in Fukushima could have major societal consequences. Given the extensive, ongoing Nuclear Regulatory Commission (NRC) and industry assessment of nuclear power plant safety and preparedness issues, the Center for Biosecurity of UPMC focused on offsite policies and plans intended to reduce radiation exposure to the public in the aftermath of an accident. This report provides an assessment of Japan's efforts at nuclear consequence management; identifies concerns with current U.S. policies and practices for "outside the fence" management of such an event in the U.S.; and makes recommendations for steps that can be taken to strengthen U.S. government, industry, and community response to large-scale accidents at nuclear power plants.