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2.  Exploring Communication, Trust in Government, and Vaccination Intention Later in the 2009 H1N1 Pandemic: Results of a National Survey 
With the growing recognition of the critical role that risk communication plays in a public health emergency, a number of articles have provided prescriptive best practices to enhance such communication. However, little empirical research has examined perceptions of the quality of communication, the impact of uncertainty on changing communication, use of information sources, and trust in specific government spokespersons. Similarly, although there is significant conceptual focus on trust and communication as important in vaccination intent and acceptance, little research has explored these relationships empirically. We conducted an online survey in late January 2010 with a nationally representative sample (N=2,079) that included Hispanic and African American oversamples. The completion rate was 56%. We found that public health officials were the most trusted spokespersons, with President Obama being the most highly trusted elected official. Demographic variables, including race, accounted for 21% of the variance in trust of the president. Perceptions of the quality of communication were high, including significant understanding of uncertainty and appreciation for officials' openness about evolving information. Other factors that contributed to vaccination acceptance were quality of communication, closely following the news, and confidence in the vaccine because of a role model effect of the Obama daughters' immunizations; these factors significantly increased trust in government actions. Because the challenges of communication often vary over the course of a pandemic, there is a consistent need to pay close attention to both communication content and delivery and prepare public health officials at all levels to be effective communicators.
Clear and consistent communication by public health and government spokespersons about vaccination during the 2009 H1N1 pandemic was important to the public's trust in government actions and increased the likelihood that people sought the vaccine. Public health officials were the most trusted spokespersons, with President Obama indicated as the most highly trusted elected official. Other factors that contributed to vaccination acceptance were the quality of the communication, closely following the news, and confidence in the vaccine because of a role model effect when President Obama had his daughters immunized.
doi:10.1089/bsp.2012.0048
PMCID: PMC3689165  PMID: 23617721
3.  Local Health Department Capacity for Community Engagement and Its Implications for Disaster Resilience 
Over the past decade, community engagement has become a central tenet of US federal doctrine on public health emergency preparedness. Little is known, however, about how the vision of a ready, aware, and involved populace has translated into local practice, or which conditions thus far have advanced community involvement in what is typically considered the province of government authorities and emergency professionals. In 2011-12, to help close that knowledge gap, investigators carried out semistructured qualitative interviews with practitioners (N=25) from 7 local health departments about which conditions have advanced or inhibited community engagement in public health emergency preparedness. Among the organizational factors identified as enabling local health departments' involvement of community residents and groups in emergency preparedness were a supportive agency leadership and culture, sufficient staffing and programmatic funding, interested and willing partners, and external triggers such as federal grants and disaster experiences that spotlighted the importance of community relationships to effective response. Facing budget and staff cuts, local health departments feel increasingly constrained in efforts to build trusted and lasting preparedness ties with community partners. At the same time, some progress in preparedness partnerships may be possible in the context of agency leadership, culture, and climate that affirms the value of collaboration with the community.
The authors conducted interviews with practitioners from 7 local health departments about which conditions have advanced or inhibited community engagement in public health emergency preparedness. Among the organizational factors identified as enabling local health departments' involvement of the community in emergency preparedness were a supportive agency leadership and culture, sufficient staffing and programmatic funding, interested and willing partners, and external triggers, such as federal grants and disaster experiences that spotlighted the importance of community relationships. Facing budget and staff cuts, local health departments feel increasingly constrained in efforts to build trusted and lasting preparedness ties with community partners.
doi:10.1089/bsp.2013.0027
PMCID: PMC3689171  PMID: 23718765
4.  Implementation of a Personnel Reliability Program as a Facilitator of Biosafety and Biosecurity Culture in BSL-3 and BSL-4 Laboratories 
In late 2010, the National Biodefense Analysis and Countermeasures Center (NBACC) implemented a Personnel Reliability Program (PRP) with the goal of enabling active participation by its staff to drive and improve the biosafety and biosecurity culture at the organization. A philosophical keystone for accomplishment of NBACC's scientific mission is simultaneous excellence in operations and outreach. Its personnel reliability program builds on this approach to: (1) enable and support a culture of responsibility based on human performance principles, (2) maintain compliance with regulations, and (3) address the risk associated with the insider threat. Recently, the Code of Federal Regulations (CFR) governing use and possession of biological select agents and toxins (BSAT) was amended to require a pre-access suitability assessment and ongoing evaluation for staff accessing Tier 1 BSAT. These 2 new requirements are in addition to the already required Federal Bureau of Investigation (FBI) Security Risk Assessment (SRA). Two years prior to the release of these guidelines, NBACC developed its PRP to supplement the SRA requirement as a means to empower personnel and foster an operational environment where any and all work with BSAT is conducted in a safe, secure, and reliable manner.
The National Biodefense Analysis and Countermeasures Center (NBACC) implemented a personnel reliability program to enable its staff to participate in improving the biosafety and biosecurity culture at the organization. The personnel reliability program enables and supports a culture of responsibility based on human performance principles, maintains compliance with regulations, and addresses the risk associated with the insider threat.
doi:10.1089/bsp.2013.0024
PMCID: PMC3689182  PMID: 23745523
5.  Detection of the Urban Release of a Bacillus anthracis Simulant by Air Sampling 
In 2005 and 2009, the Pentagon Force Protection Agency (PFPA) staged deliberate releases of a commercially available organic pesticide containing Bacillus amyloliquefaciens to evaluate PFPA's biothreat response protocols. In concert with, but independent of, these releases, the Department of Homeland Security sponsored experiments to evaluate the efficacy of commonly employed air and surface sampling techniques for detection of an aerosolized biological agent. High-volume air samplers were placed in the expected downwind plume, and samples were collected before, during, and after the releases. Environmental surface and personal air samples were collected in the vicinity of the high-volume air samplers hours after the plume had dispersed. The results indicate it is feasible to detect the release of a biological agent in an urban area both during and after the release of a biological agent using high-volume air and environmental sampling techniques.
In 2005 and 2009, the Pentagon Force Protection Agency staged deliberate releases of a commercially available organic pesticide to evaluate biothreat response protocols. The Department of Homeland Security also sponsored experiments to evaluate the efficacy of commonly employed air and surface sampling techniques to detect an aerosolized biological agent. High-volume air samplers were placed in the expected downwind plume, and samples were collected before, during, and after the releases. The results indicate it is feasible to detect the release of a biological agent in an urban area both during and after its release using high-volume air and environmental sampling techniques.
doi:10.1089/bsp.2013.0086
PMCID: PMC3993016  PMID: 24697146
6.  Assessment of Medical Reserve Corps Volunteers' Emergency Response Willingness Using a Threat- and Efficacy-Based Model 
The goal of this study was to investigate the willingness of Medical Reserve Corps (MRC) volunteers to participate in public health emergency–related activities by assessing their attitudes and beliefs. MRC volunteers responded to an online survey organized around the Extended Parallel Process Model (EPPM). Respondents reported agreement with attitude/belief statements representing perceived threat, perceived efficacy, and personal/organizational preparedness in 4 scenarios: a weather-related disaster, a pandemic influenza emergency, a radiological (“dirty bomb”) emergency, and an inhalational anthrax bioterrorism emergency. Logistic regression analyses were used to evaluate predictors of volunteer response willingness. In 2 response contexts (if asked and regardless of severity), self-reported willingness to respond was higher among those with a high perceived self-efficacy than among those with low perceived self-efficacy. Analyses of the association between attitude/belief statements and the EPPM profiles indicated that, under all 4 scenarios and with few exceptions, those with a perceived high threat/high efficacy EPPM profile had statistically higher odds of agreement with the attitude/belief statements than those with a perceived low threat/low efficacy EPPM profile. The radiological emergency consistently received the lowest agreement rates for the attitude/belief statements and response willingness across scenarios. The findings suggest that enrollment with an MRC unit is not automatically predictive of willingness to respond in these types of scenarios. While MRC volunteers' self-reported willingness to respond was found to differ across scenarios and among different attitude and belief statements, the identification of self-efficacy as the primary predictor of willingness to respond regardless of severity and if asked highlights the critical role of efficacy in an organized volunteer response context.
This study investigated the willingness of Medical Reserve Corps (MRC) volunteers to participate in public health emergency–related activities by assessing their attitudes and beliefs. MRC volunteers responded to an online survey and reported agreement with attitude/belief statements in 4 scenarios: a weather-related disaster, a pandemic influenza emergency, a radiological (“dirty bomb”) emergency, and an inhalational anthrax bioterrorism emergency. The volunteers' willingness to respond was found to differ across scenarios and among different attitude/belief statements, with self-efficacy being the primary predictor of willingness to respond.
doi:10.1089/bsp.2012.0047
PMCID: PMC3612278  PMID: 23477632
7.  Biosecurity and the Review and Publication of Dual-Use Research of Concern 
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.
Journal editors play a vital role in ensuring that effective safeguards exist to cope with the risks of publishing scientific research with dual-use implications. The authors 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 had experience with biosecurity review, and no editor in our study reported having ever refused a submission on biosecurity grounds.
doi:10.1089/bsp.2012.0011
PMCID: PMC3440065  PMID: 22871221
8.  Cost-Effectiveness Comparison of Response Strategies to a Large-Scale Anthrax Attack on the Chicago Metropolitan Area: Impact of Timing and Surge Capacity 
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.
Rapid public health response to a large-scale anthrax attack would reduce overall morbidity and mortality, but what is the optimal cost-effective response strategy for timing of intervention, public health resources, and critical care facilities? Using a hypothetical large-scale anthrax attack on the Chicago metropolitan area, this study compared response strategies that would begin either 2 days or 5 days after the attack and would consist of administering prophylaxis and vaccine in various combinations. The findings support the 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.
doi:10.1089/bsp.2011.0105
PMCID: PMC3440066  PMID: 22845046
9.  IDSR as a Platform for Implementing IHR in African Countries 
Of the 46 countries in the World Health Organization (WHO) African region (AFRO), 43 are implementing Integrated Disease Surveillance and Response (IDSR) guidelines to improve their abilities to detect, confirm, and respond to high-priority communicable and noncommunicable diseases. IDSR provides a framework for strengthening the surveillance, response, and laboratory core capacities required by the revised International Health Regulations [IHR (2005)]. In turn, IHR obligations can serve as a driving force to sustain national commitments to IDSR strategies. The ability to report potential public health events of international concern according to IHR (2005) relies on early warning systems founded in national surveillance capacities. Public health events reported through IDSR to the WHO Emergency Management System in Africa illustrate the growing capacities in African countries to detect, assess, and report infectious and noninfectious threats to public health. The IHR (2005) provide an opportunity to continue strengthening national IDSR systems so they can characterize outbreaks and respond to public health events in the region.
Of the 46 countries in the WHO African region, 43 are implementing Integrated Disease Surveillance and Response (IDSR) guidelines to improve their abilities to detect, confirm, and respond to high-priority communicable and noncommunicable diseases. IDSR provides a framework for strengthening the surveillance, response, and laboratory core capacities required by the revised International Health Regulations [IHR (2005)]. In turn, IHR obligations can motivate sustained national commitment to IDSR strategies. The ability to report potential public health events of international concern relies on early warning systems founded in national surveillance capacities. The IHR (2005) provide an opportunity to continue strengthening national surveillance systems so they can characterize outbreaks and respond to public health events in the region.
doi:10.1089/bsp.2013.0032
PMCID: PMC3779000  PMID: 24041192
10.  Biosecurity Measures in 48 Isolation Facilities Managing Highly Infectious Diseases 
Biosecurity measures are traditionally applied to laboratories, but they may also be usefully applied in highly specialized clinical settings, such as the isolation facilities for the management of patients with highly infectious diseases (eg, viral hemorrhagic fevers, SARS, smallpox, potentially severe pandemic flu, and MDR- and XDR-tuberculosis). In 2009 the European Network for Highly Infectious Diseases conducted a survey in 48 isolation facilities in 16 European countries to determine biosecurity measures for access control to the facility. Security personnel are present in 39 facilities (81%). In 35 facilities (73%), entrance to the isolation area is restricted; control methods include electronic keys, a PIN system, closed-circuit TV, and guards at the doors. In 25 facilities (52%), identification and registration of all staff entering and exiting the isolation area are required. Access control is used in most surveyed centers, but specific lacks exist in some facilities. Further data are needed to assess other biosecurity aspects, such as the security measures during the transportation of potentially contaminated materials and measures to address the risk of an “insider attack.”
Biosecurity measures are traditionally applied to laboratories, but they may also be usefully applied in highly specialized clinical settings, such as isolation facilities for patients with highly infectious diseases. In 2009 the European Network for Highly Infectious Diseases conducted a survey in 48 isolation facilities in 16 European countries to determine which biosecurity measures for access control to the facility were being used.
doi:10.1089/bsp.2011.0098
PMCID: PMC3374382  PMID: 22571373
11.  Differentiating Microbial Forensic qPCR Target and Control Products by Electrospray Ionization Mass Spectrometry 
Molecular bioforensic research is dependent on rapid and sensitive methods such as real-time PCR (qPCR) for the identification of microorganisms. The use of synthetic positive control templates containing small modifications outside the primer and probe regions is essential to ensure all aspects of the assay are functioning properly, including the primers and probes. However, a typical qPCR or reverse transcriptase qPCR (qRT-PCR) assay is limited in differentiating products generated from positive controls and biological samples because the fluorescent probe signals generated from each type of amplicon are indistinguishable. Additional methods used to differentiate amplicons, including melt curves, secondary probes, and amplicon sequencing, require significant time to implement and validate and present technical challenges that limit their use for microbial forensic applications. To solve this problem, we have developed a novel application of electrospray ionization mass spectrometry (ESI-MS) to rapidly differentiate qPCR amplicons generated with positive biological samples from those generated with synthetic positive controls. The method has sensitivity equivalent to qPCR and supports the confident and timely determination of the presence of a biothreat agent that is crucial for policymakers and law enforcement. Additionally, it eliminates the need for time-consuming methods to confirm qPCR results, including development and validation of secondary probes or sequencing of small amplicons. In this study, we demonstrate the effectiveness of this approach with microbial forensic qPCR assays targeting multiple biodefense agents (bacterial, viral, and toxin) for the ability to rapidly discriminate between a positive control and a positive sample.
Molecular bioforensic research depends on rapid, sensitive methods such as real-time PCR (qPCR) to identify microorganisms. The authors developed a novel application of electrospray ionization mass spectrometry (ESI-MS) to rapidly differentiate qPCR amplicons generated with positive biological samples from those generated with synthetic positive controls. The method has sensitivity equivalent to qPCR and supports the confident and timely determination of the presence of a biothreat agent, which is crucial for policymakers and law enforcement. It also eliminates the need for time-consuming methods to confirm qPCR results.
doi:10.1089/bsp.2012.0062
PMCID: PMC3696942  PMID: 23675878
12.  Perspectives of Immunization Program Managers on 2009-10 H1N1 Vaccination in the United States: A National Survey 
Abstract
In June and July 2010, we conducted a national internet-based survey of 64 city, state, and territorial immunization program managers (IPMs) to assess their experiences in managing the 2009-10 H1N1 influenza vaccination campaign. Fifty-four (84%) of the managers or individuals responsible for an immunization program responded to the survey. To manage the campaign, 76% indicated their health department activated an incident command system (ICS) and 49% used an emergency operations center (EOC). Forty percent indicated they shared the leadership of the campaign with their state-level emergency preparedness program. The managers' perceptions of the helpfulness of the emergency preparedness staff was higher when they had collaborated with the emergency preparedness program on actual or simulated mass vaccination events within the previous 2 years. Fifty-seven percent found their pandemic influenza plan helpful, and those programs that mandated that vaccine providers enter data into their jurisdiction's immunization information system (IIS) were more likely than those who did not mandate data entry to rate their IIS as valuable for facilitating registration of nontraditional providers (42% vs. 25%, p<0.05) and tracking recalled influenza vaccine (50% vs. 38%, p<0.05). Results suggest that ICS and EOC structures, pandemic influenza plans, collaborations with emergency preparedness partners during nonemergencies, and expanded use of IIS can enhance immunization programs' ability to successfully manage a large-scale vaccination campaign. Maintaining the close working relationships developed between state-level immunization and emergency preparedness programs during the H1N1 influenza vaccination campaign will be especially important as states prepare for budget cuts in the coming years.
The authors conducted a study of state and local immunization program managers to assess their experiences in managing the 2009-10 H1N1 influenza vaccination campaign. Results suggest that incident command and emergency operations center structures, pandemic influenza plans, collaborations with emergency preparedness partners during nonemergencies, and expanded use of immunization information systems are important in successfully managing a large-scale vaccination campaign.
doi:10.1089/bsp.2011.0077
PMCID: PMC3316479  PMID: 22360580
13.  Southeastern Center for Emerging Biologic Threats Tabletop Exercise: Foodborne Toxoplasmosis Outbreak on College Campuses 
The use of tabletop exercises as a tool in emergency preparedness and response has proven to be an effective means of assessing readiness for unexpected events. Whereas most exercise developers target a population in a defined space (eg, state, county, metropolitan area, hospital), the Southeastern Center for Emerging Biologic Threats (SECEBT) conducted an innovative tabletop exercise involving an unusual foodborne outbreak pathogen, targeting public health agencies and academic institutions in 7 southeastern states. The exercise tested the ability of participants to respond to a simulated foodborne disease outbreak affecting the region. The attendees represented 4 federal agencies, 9 state agencies, 6 universities, 1 nonprofit organization, and 1 private corporation. The goals were to promote collaborative relationships among the players, identify gaps in plans and policies, and identify the unique contributions of each organization—and notably academic institutions—to outbreak recognition, investigation, and control. Participants discussed issues and roles related to outbreak detection and management, risk communication, and coordination of policies and responsibilities before, during, and after an emergency, with emphasis on assets of universities that could be mobilized during an outbreak response. The exercise generated several lessons and recommendations identified by participants and evaluators. Key recommendations included a need to establish trigger points and protocols for information sharing and alerts among public health, academic, and law enforcement; to establish relationships with local, state, and federal stakeholders to facilitate communications during an emergency; and to catalogue and leverage strengths, assets, and priorities of academic institutions to add value to outbreak responses.
A tabletop exercise simulated a foodborne outbreak and involved representatives from federal and state agencies, universities, a nonprofit organization, and a corporation. The exercise pointed up the need to establish working relationships before an emergency and suggested that the resources of academic institutions could be used to good advantage.
doi:10.1089/bsp.2011.0040
PMCID: PMC3316480  PMID: 22283568
14.  Modeling Inhalational Tularemia: Deliberate Release and Public Health Response 
Two epidemic modeling studies of inhalational tularemia were identified in the published literature, both demonstrating the high number of potential casualties that could result from a deliberate aerosolized release of the causative agent in an urban setting. However, neither study analyzed the natural history of inhalational tularemia nor modeled the relative merits of different mitigation strategies. We first analyzed publicly available human/primate experimental data and reports of naturally acquired inhalational tularemia cases to better understand the epidemiology of the disease. We then simulated an aerosolized release of the causative agent, using airborne dispersion modeling to demonstrate the potential number of casualties and the extent of their spatial distribution. Finally, we developed a public health intervention model that compares 2 mitigation strategies: targeting antibiotics at symptomatic individuals with or without mass distribution of antibiotics to potentially infected individuals. An antibiotic stockpile that is sufficient to capture all areas where symptomatic individuals were infected is likely to save more lives than treating symptomatic individuals alone, providing antibiotics can be distributed rapidly and their uptake is high. However, with smaller stockpiles, a strategy of treating symptomatic individuals alone is likely to save many more lives than additional mass distribution of antibiotics to potentially infected individuals. The spatial distribution of symptomatic individuals is unlikely to coincide exactly with the path of the dispersion cloud if such individuals are infected near their work locations but then seek treatment close to their homes. The optimal mitigation strategy will depend critically on the size of the release relative to the stockpile level and the effectiveness of treatment relative to the speed at which antibiotics can be distributed.
The authors analyzed publicly available data and reports of inhalational tularemia cases to better understand the epidemiology of the disease. They then simulated an aerosolized release of the causative agent, using airborne dispersion modeling to demonstrate the potential number of casualties and the extent of their distribution. Finally, they developed a public health intervention model that compares 2 mitigation strategies: targeting antibiotics at symptomatic individuals with or without mass distribution of antibiotics to potentially infected people.
doi:10.1089/bsp.2011.0004
PMCID: PMC3223019  PMID: 22044315
15.  The Civil Air Patrol's Role in Medical Countermeasure Distribution in Michigan 
Michigan's unique geological features and highly variable climatic conditions make distribution of medical countermeasures during a public health emergency situation very challenging. To enhance distribution during these situations, the Civil Air Patrol (CAP) has agreed to support the state of Michigan by transporting life-saving medical countermeasures to remote areas of the state. The Michigan Strategic National Stockpile (MISNS) program has successfully developed, exercised, and enhanced its partnership with the CAP to include distribution of federally provided Strategic National Stockpile (SNS) assets. The CAP has proven to be a reliable and valuable partner, as well as a cost-effective and time-efficient means of transporting vital resources during a public health emergency.
Michigan's unique geological features and highly variable climate make distribution of medical countermeasures during a public health emergency situation challenging. The Civil Air Patrol agreed to transport life-saving medical countermeasures to remote areas of the state. The program was successfully developed and exercised.
doi:10.1089/bsp.2011.0016
PMCID: PMC3223014  PMID: 22060035
16.  Evaluation of Perceived Threat Differences Posed by Filovirus Variants 
In the United States, filoviruses (ebolaviruses and marburgviruses) are listed as National Institute of Allergy and Infectious Diseases (NIAID) Category A Priority Pathogens, Select Agents, and Centers for Disease Control and Prevention (CDC) Category A Bioterrorism Agents. In recent months, U.S. biodefense professionals and policy experts have initiated discussions on how to optimize filovirus research in regard to medical countermeasure (ie, diagnostics, antiviral, and vaccine) development. Standardized procedures and reagents could accelerate the independent verification of research results across government agencies and establish baselines for the development of animal models acceptable to regulatory entities, such as the Food and Drug Administration (FDA), while being fiscally responsible. At the root of standardization lies the question of which filovirus strains, variants, or isolates ought to be the prototypes for product development, evaluation, and validation. Here we discuss a rationale for their selection. We conclude that, based on currently available data, filovirus biodefense research ought to focus on the classical taxonomic filovirus prototypes: Marburg virus Musoke in the case of marburgviruses and Ebola virus Mayinga in the case of Zaire ebolaviruses. Arguments have been made in various committees in favor of other variants, such as Marburg virus Angola, Ci67 or Popp, or Ebola virus Kikwit, but these rationales seem to be largely based on anecdotal or unpublished and unverified data, or they may reflect a lack of awareness of important facts about the variants' isolation history and genomic properties.
Standardized procedures and reagents could accelerate the independent verification of research results across government agencies and establish baselines for the development of animal models acceptable to regulatory entities. At the root of standardization lies the question of which filovirus strains, variants, or isolates ought to be the prototypes for product development, evaluation, and validation. The authors discuss a rationale for selection and conclude that filovirus biodefense research ought to focus on the classical taxonomic filovirus prototypes.
doi:10.1089/bsp.2011.0051
PMCID: PMC3233913  PMID: 22070137
17.  Reaerosolization of Bacillus spp. in Outdoor Environments: A Review of the Experimental Literature 
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.
Reaerosolization or resuspension—that is, the reintroduction of previously airborne particles into the atmosphere—is 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 to summarize the current state of our understanding of Bacillus spp. reaerosolization in outdoor environments.
doi:10.1089/bsp.2012.0026
PMCID: PMC3440029  PMID: 22871211
18.  Dual-Use Review Policies of Biomedical Research Journals 
The authors surveyed life science journals to determine how many have a policy concerning dual-use research. Of the 155 journals that responded, only 7.7% stated that they had a written dual-use policy and only 5.8% said they had experience reviewing dual-use research in the past 5 years.
To address biosecurity issues, government agencies, academic institutions, and professional societies have developed policies concerning the publication of “dual-use” biomedical research—that is, research that could be readily applied to cause significant harm to the public, the environment, or national security. We conducted an e-mail survey of life science journals to determine the percentage that have a dual-use policy. Of the 155 journals that responded to our survey (response rate 39%), only 7.7% stated that they had a written dual-use policy and only 5.8% said they had experience reviewing dual-use research in the past 5 years. Among the potential predictors we investigated, the one most highly associated with a journal having a written dual-use policy was membership in the Nature Publishing Group (positive association). When considered individually, both previous experience with reviewing dual-use research and the journal's impact factor appeared to be positively associated with having a written dual-use policy, but only the former remained significant after adjusting for publishing group. Although preventing the misuse of scientific research for terrorist or criminal purposes is an important concern, few biomedical journals have dual-use review policies. Journals that are likely to review research that raises potential dual-use concerns should consider developing dual-use policies.
doi:10.1089/bsp.2010.0067
PMCID: PMC3063694  PMID: 21395429
19.  Developing a Behavioral Health Screening Program for BSL-4 Laboratory Workers at the National Institutes of Health 
To ensure that biomedical research is performed in the safest and most responsible manner possible, the NIH established the Biological Surety Program (BSP) in 2006 to reflect the unique human and security factors associated with biosafety level 4 (BSL-4) laboratories. The program sets forth control measures to ensure there is a trained, responsible, and reliable workforce, with rigorous procedures to protect employee health and maintain a safe work environment.
The events and aftermath of September 11, 2001, accelerated a search for personnel reliability test measures to identify individuals who could pose a threat to our nation's security and safety. The creation and administration of a behavioral health screen for BSL-4 laboratory workers at the National Institutes of Health represents a pioneering effort to proactively build a BSL-4 safety culture promoting worker cohesiveness, trust, respect, and reliability with a balance of worker privacy and public safety.
doi:10.1089/bsp.2010.0048
PMCID: PMC3063697  PMID: 21361798
20.  The NIAID Radiation Countermeasures Program Business Model 
The National Institute of Allergy and Infectious Diseases (NIAID) Radiation/Nuclear Medical Countermeasures Development Program has developed an integrated approach to providing the resources and expertise required for the research, discovery, and development of radiation/nuclear medical countermeasures (MCMs). These resources and services lower the opportunity costs and reduce the barriers to entry for companies interested in working in this area and accelerate translational progress by providing goal-oriented stewardship of promising projects. In many ways, the radiation countermeasures program functions as a “virtual pharmaceutical firm,” coordinating the early and mid-stage development of a wide array of radiation/nuclear MCMs. This commentary describes the radiation countermeasures program and discusses a novel business model that has facilitated product development partnerships between the federal government and academic investigators and biopharmaceutical companies.
doi:10.1089/bsp.2010.0041
PMCID: PMC3011992  PMID: 21142762
21.  Response to H1N1 in a U.S.-Mexico Border Community 
Public health experts from a county health department and a school of public health in Texas collaborated to establish a simple, functional surveillance system to monitor 2009 H1N1 influenza virus as it crossed from Mexico into a Texas border community. They used GIS mapping and reports of school and daycare absences to guide their response to the outbreak.
Public health experts from a county health department and a school of public health collaborated to establish a simple, functional surveillance system to monitor swine-origin influenza virus as it crossed from Mexico into a Texas border community during the 2009 pandemic. The draft national and state preparedness plans were found to be cumbersome at the local level, so a simple, more practical real-time surveillance and response system was developed, in part by modifying these documents, and immediately implemented. Daily data analyses, including geographical information system mapping of cases and reports of school and daycare absences, were used for outbreak management. Aggregate reports of influenzalike illness and primary school absences were accurate in predicting influenza activity and were practical for use in local tracking, making decisions, and targeting interventions. These simple methods should be considered for local implementation and for integration into national recommendations for epidemic preparedness and response.
doi:10.1089/bsp.2010.0014
PMCID: PMC2982707  PMID: 20825334
22.  Transport of Bacillus Thuringiensis var. Kurstaki Via Fomites 
The intentional and controlled release of an aerosolized bacterium provides an opportunity to investigate the implications of a biological attack. Since 2006, Los Alamos National Laboratory has worked with several urban areas, including Fairfax County, VA, to design experiments to evaluate biodefense concepts of operations using routine spraying of Bacillus thuringiensis var. kurstaki (Btk). Btk is dispersed in large quantities as a slurry to control the gypsy moth, Lymantria dispar. Understanding whether personnel and equipment pick up residual contamination during sampling activities and transport it to other areas is critical for the formulation of appropriate response and recovery plans. While there is a growing body of literature surrounding the transmission of viral diseases via fomites, there is limited information on the transport of Bacillus species via this route. In 2008, LANL investigated whether field sampling activities conducted near sprayed areas, post-spray, resulted in measurable cross-contamination of sampling personnel, equipment, vehicles, and hotel rooms. Viable Btk was detected in all sample types, indicating transport of the agent occurred via fomites.
doi:10.1089/bsp.2010.0073
PMCID: PMC3166204  PMID: 21882970
23.  Destruction of Microbial Collections in Response to Select Agent and Toxin List Regulations 
Anecdotal evidence has indicated that microbial collections have been destroyed in the U.S. following the imposition of the regulations associated with the Select Agents and Toxins List. The authors confirmed, by means of a questionnaire, that this has occurred in at least 13 cases.
In this study we have followed up on anecdotal and hearsay evidence that microbial collections were destroyed in the United States following the imposition of the regulations associated with the Select Agents and Toxins List, to validate or refute that information. Using a questionnaire, we documented 13 episodes of microbial collection destruction involving viral, bacterial, and fungal strains, which we believe is almost certainly an underestimate of the number of collections destroyed. In every case, the motivation for the destruction of the collection was a desire to avoid the perceived burdens of the regulatory environment associated with operating under the Select Agent Regulations. Some institutions that destroyed isolates considered, and in some cases tried, transferring their collections to registered institutions prior to collection destruction but desisted when confronted with transport regulations. Destruction of microbial collections represents a loss of strains and biological diversity available for biomedical research and future mechanistic, forensic, and epidemiologic investigations. Given the rapid evolution of microbial strains, the destruction of archival collections is a potentially irretrievable loss that was an unintended consequence of regulations to protect society against the nefarious use of biological agents. Furthermore, unregistered institutions continue to destroy newly acquired clinical isolates, thus preventing the establishment of new repository collections. We recommend that government agencies develop plans to ensure that microbial collections are preserved when considering future additions to microbial threat lists under which the possession of certain microbes is criminalized.
doi:10.1089/bsp.2010.0012
PMCID: PMC2982716  PMID: 20569056
24.  Improving the Evidence Base for Decision Making During a Pandemic: The Example of 2009 Influenza A/H1N1 
This article synthesizes and extends discussions held during an international meeting on “Surveillance for Decision Making: The Example of 2009 Pandemic Influenza A/H1N1,” held at the Center for Communicable Disease Dynamics (CCDD), Harvard School of Public Health, on June 14 and 15, 2010. The meeting involved local, national, and global health authorities and academics representing 7 countries on 4 continents. We define the needs for surveillance in terms of the key decisions that must be made in response to a pandemic: how large a response to mount and which control measures to implement, for whom, and when. In doing so, we specify the quantitative evidence required to make informed decisions. We then describe the sources of surveillance and other population-based data that can presently—or in the future—form the basis for such evidence, and the interpretive tools needed to process raw surveillance data. We describe other inputs to decision making besides epidemiologic and surveillance data, and we conclude with key lessons of the 2009 pandemic for designing and planning surveillance in the future.
This article synthesizes discussions held during an international meeting, “Surveillance for Decision Making: The Example of 2009 Pandemic Influenza A/H1N1,” held at Harvard School of Public Health in June 2010. It defines the needs for surveillance in terms of the key decisions that must be made in response to a pandemic: how large a response to mount and which control measures to implement, for whom, and when. The article describes the sources of surveillance and other population-based data that can form the basis for such evidence, and the interpretive tools needed to process raw surveillance data. It concludes with key lessons of the 2009 pandemic for designing and planning surveillance in the future.
doi:10.1089/bsp.2011.0007
PMCID: PMC3102310  PMID: 21612363
25.  Exposure to Bioterrorism and Mental Health Response among Staff on Capitol Hill 
The October 2001 anthrax attacks heralded a new era of bioterrorism threat in the U.S. At the time, little systematic data on mental health effects were available to guide authorities' response. For this study, which was conducted 7 months after the anthrax attacks, structured diagnostic interviews were conducted with 137 Capitol Hill staff workers, including 56 who had been directly exposed to areas independently determined to have been contaminated. Postdisaster psychopathology was associated with exposure; of those with positive nasal swab tests, PTSD was diagnosed in 27% and any post-anthrax psychiatric disorder in 55%. Fewer than half of those who were prescribed antibiotics completed the entire course, and only one-fourth had flawless antibiotic adherence. Thirty percent of those not exposed believed they had been exposed; 18% of all study participants had symptoms they suspected were symptoms of anthrax infection, and most of them sought medical care. Extrapolation of raw numbers to large future disasters from proportions with incorrect belief in exposure in this limited study indicates a potential for important public health consequences, to the degree that people alter their healthcare behavior based on incorrect exposure beliefs. Incorrect belief in exposure was associated with being very upset, losing trust in health authorities, having concerns about mortality, taking antibiotics, and being male. Those who incorrectly believe they were exposed may warrant concern and potential interventions as well as those exposed. Treatment adherence and maintenance of trust for public health authorities may be areas of special concern, warranting further study to inform authorities in future disasters involving biological, chemical, and radiological agents.
doi:10.1089/bsp.2009.0031
PMCID: PMC2956562  PMID: 20028246

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