Showing papers in "Biosecurity and Bioterrorism-biodefense Strategy Practice and Science in 2009"

Public Willingness to Take a Vaccine or Drug Under Emergency Use Authorization during the 2009 H1N1 Pandemic

Abstract: On April 26, 2009, the United States declared a public health emergency in response to a growing but uncertain threat from H1N1 influenza, or swine flu. In June, the World Health Organization declared a pandemic. In the U.S., hospitalizations due to swine flu numbered 6,506 on August 6, 2009, with 436 deaths; all 50 states have reported cases. The declaration of a public health emergency, followed by the approval of multiple Emergency Use Authorizations (EUAs) by the Food and Drug Administration, allowed the distribution of unapproved drugs or the off-label use of approved drugs to the public. Thus far, there are 2 antiviral medications available to the public as EUA drugs. It is possible that an H1N1 vaccine will be initially released as an EUA in the fall in the first large-scale use of the EUA mechanism. This study explores the public's willingness to use a drug or vaccine under the conditions stipulated in the FDA's nonbinding guidance regarding EUAs. Using Knowledge Networks' panel, we conducted an i...

Factors predicting individual emergency preparedness: a multi-state analysis of 2006 BRFSS data

Abstract: Disasters pose a very real threat to every individual in the United States. One way to mitigate the threat of disasters is through personal preparedness, yet numerous studies indicate that individual Americans are not prepared for a disaster. This study attempted to identify the factors most likely to predict individual disaster preparedness. We used 2006 Behavioral Risk Factor Surveillance System (BRFSS) data from the 5 states that included the optional general preparedness module. Respondents were defined as being "prepared" if they were deficient in no more than 1 of the 6 actionable preparedness measures included on the BRFSS. Analyses were conducted comparing preparedness rates based on medical and demographic factors. Using logistic regression, a predictive model was constructed to identify which factors most strongly predicted an individual's likelihood of being prepared. Although 78% of respondents reported feeling prepared for a disaster, just 45% of respondents were actually prepared by objective measures. Factors predicting an increased likelihood of preparedness included feeling "well prepared" (OR 9.417), having a disability or health condition requiring special equipment (OR 1.298), being 55 to 64 years old (OR 1.794), and having an annual income above $50,000 (OR 1.286). Among racial and ethnic minorities, an inability to afford medical care in the previous year (OR .581) was an important factor in predicting a decreased likelihood of being prepared. This study revealed a pervasive lack of disaster preparedness overall and a substantial gap between perceived and objective preparedness. Income and age were important predictors of disaster preparedness.

Public health and medical responses to the 1957-58 influenza pandemic.

Abstract: As the U.S. prepares to respond this fall and winter to pandemic (H1N1) 2009, a review of the 1957-58 pandemic of Asian influenza (H2N2) could be useful for planning purposes because of the many similarities between the 2 pandemics. Using historical surveillance reports, published literature, and media coverage, this article provides an overview of the epidemiology of and response to the 1957-58 influenza pandemic in the U.S., during which an estimated 25% of the population became infected with the new pandemic virus strain. While it cannot be predicted with absolute certainty how the H1N1 pandemic might play out in the U.S. this fall, lessons from the 1957-58 influenza pandemic provide useful and practical insights for current planning and response efforts.

Situational uses of syndromic surveillance.

Abstract: Since 2001, many state and local health departments have implemented automated systems to monitor healthcare use and to promptly identify and track epidemics and other public health threats. In 2007-08, we conducted case studies of selected events with actual or potential public health impacts to determine whether and how health departments and hospitals used these new systems. We interviewed public health and hospital representatives and applied qualitative analysis methods to identify response themes. So-called “syndromic” surveillance methods were most useful in situations with widespread health effects, such as respiratory illness associated with seasonal influenza or exposures to smoke from wildfires. In other instances, such as a tornado or hazardous material exposures, these systems were useful for detecting or monitoring health impacts that affected relatively few people, or they were used to affirm the absence of outbreaks following natural disasters or the detection of a potential pathogen in ai...

Alphavirus antiviral drug development: scientific gap analysis and prospective research areas.

Abstract: The New World alphaviruses Venezuelan equine encephalitis virus (VEEV), eastern equine encephalitis virus (EEEV), and western equine encephalitis virus (WEEV) pose a significant threat to human health as the etiological agents of serious viral encephalitis through natural infection as well as through their potential use as a biological weapon. At present, there is no FDA-approved medical treatment for infection with these viruses. The Defense Threat Reduction Agency, Joint Science and Technology Office for Chemical and Biological Defense (DTRA/JSTO), is currently funding research aimed at developing antiviral drugs and vaccines against VEEV, EEEV, and WEEV. A review of antiviral drug discovery efforts for these viruses revealed significant gaps in the data, assays, and models required for successful drug development. This review provides a description of these gaps and highlights specific critical research areas for the development of a target-based drug discovery program for the VEEV, EEEV, and WEEV nons...

Palliative care considerations in mass casualty events with scarce resources

Abstract: Catastrophic mass casualty events, such as pandemic flu outbreaks or large-scale terrorism-related events, could yield thousands of victims whose needs would overwhelm local and regional healthcare systems, personnel, and resources. Such conditions will require deploying scarce resources in a manner that is different from the more common single-event disaster. This article introduces the topic of palliative care during a mass casualty event and reviews the major findings for a federally funded planning guide that examined palliative care issues associated with providing medical care under circumstances where resources are scarce. We focus on the role of palliative care in the support of individuals not expected to survive and offer recommendations of specific actions for a coordinated disaster response plan. Semistructured telephone discussions with disaster management experts and a group meeting of experts identified issues, roles, responsibilities, procedures, and resources that offer the benefits of integrating palliative care into disaster planning and response. The investigations identified 5 domains of concern, along with guidance: (1) the role of palliative care in a mass casualty event with resulting scarce resources; (2) the triage and ensuing treatment decisions for those "likely to die"; (3) the critical palliative care services to provide, along with the personnel and settings; (4) the pragmatic plans needed for ensuring training, supplies, and organizational or jurisdictional arrangements; and (5) unusual issues affecting palliative care under mass casualty event scenarios. Palliative care minimizes the suffering of those who die, ensures comfort, addresses their needs, and may also free up resources to optimize survival of others. Planning to provide palliative care during mass casualty events should be part of the current state and local disaster planning/training guidelines, protocols, and activities.

Healthcare coalitions: the new foundation for national healthcare preparedness and response for catastrophic health emergencies.

Abstract: After 9/11 and the 2001 anthrax letters, it was evident that our nation's healthcare system was largely underprepared to handle the unique needs and large volumes of people who would seek medical care following catastrophic health events In response, in 2002 Congress established the Hospital Preparedness Program (HPP) in the US Department of Health and Human Services (HHS) to strengthen the ability of US hospitals to prepare for and respond to bioterrorism and naturally occurring epidemics and disasters Since 2002, the program has resulted in substantial improvements in individual hospitals' disaster readiness In 2007, the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) contracted with the Center for Biosecurity of the University of Pittsburgh Medical Center to conduct an assessment of US hospital preparedness and to develop tools and recommendations for evaluating and improving future hospital preparedness efforts One of the most important findings from this work is that healthcare coalitions-collaborative groups of local healthcare institutions and response agencies that work together to prepare for and respond to emergencies-have emerged throughout the US since the HPP began This article provides an overview of the HPP and the Center's hospital preparedness research for ASPR Based on that work, the article also defines healthcare coalitions and identifies their structure and core functions, provides examples of more developed coalitions and common challenges faced by coalitions, and proposes that healthcare coalitions should become the foundation of a national strategy for healthcare preparedness and response for catastrophic health events

Maximizing state and local medical countermeasure stockpile investments through the shelf-life extension program

Abstract: 101 THE U.S. DEPARTMENT OF DEFENSE (DoD) and other federal agencies, including the U.S. Department of Health and Human Services (HHS) through its Strategic National Stockpile (SNS), maintain significant amounts of pre-positioned medicines and vaccines—also known as medical countermeasures—to prepare for public health and medical emergencies. To have rapid access to critical medicines to protect their first responders, healthcare workers, and other critical infrastructure (as well as the general public, under certain circumstances) before the SNS or other federal assets arrive in response to a public health emergency, many states and local jurisdictions have also purchased and locally pre-positioned their own supplies of antivirals (eg, Tamiflu® for an influenza pandemic) and antibiotics (eg, ciprofloxacin and doxycycline for an anthrax attack). While all medicines have an expiration date set by the manufacturer, the actual shelf life of certain products, if stored properly, can be much longer.1,2 In the mid-1980s, the military faced challenges with expiring stockpiles of critical medicines, which led to the development of the Shelf-Life Extension Program (SLEP). This federal initiative is designed to defer and reduce the replacement costs of federal stockpiles of critical medicine by extending the drugs’ useful shelf life through periodic Food and Drug Administration (FDA) stability testing and strict environmental controls.3,4 Currently, only select federal stockpiles are eligible for SLEP; state and local medical countermeasure stockpiles are not permitted to participate, and no similar program exists for these caches.5 Therefore, the antivirals and antibiotics being stockpiled at the state and local levels must be discarded when their expiration date is reached, even though federal agencies participating in SLEP are receiving shelflife extensions for the same medicines and federal funds or federal subsidies have often been used to purchase the stockpiles. Because of a lack of practical alternatives, including product rotation, state and local jurisdictions that stockpile countermeasures will have caches of medicine with expired dates of use. The impact of this is significant, as it will lead to an additional and unnecessary taxpayer burden to regularly replace expired stockpiles every few years. It also has the potential to put critical health and infrastructure employees at risk during actual emergencies if jurisdictions facing budget constraints determine that they are unable to afford to replace their expired caches. This article provides an overview of SLEP and its shelflife and cost benefits, state and local antiviral and antibiotic stockpiling efforts, and recommendations for maximizing the shelf life of critical medicines being stockpiled at the

A new model of bioterrorism risk assessment.

Abstract: There has been an abundance of different bioterrorist attack scenarios and consequently an unclear biodefense strategy so far. We present a framework for bioterrorism risk assessment that we believe would be useful for policymakers and understandable without needing to be an expert in this field. We retrieved the Medline database via PubMed (from January 1987 to January 2009) and cross-referenced and reviewed the terms biological weapons, biological attacks, bioterror, bio(defense), bio(strategy) and epidemiologic models, and risk assessment. Additionally, we conducted an internet search with the same terms and strategy. We divided bioterrorist attacks into 3 categories: strategical (large-scale), operational (middle-scale), and tactical (small-scale). A bioterrorist attack is presented as a 4-component chain model, including perpetrators, agents, means of delivery, and targets. For any of these 4 components, we propose quantitative and qualitative risk assessment parameters. Here we present a simple scor...

Trust Across Borders: Responding to 2009 H1N1 Influenza in the Middle East

Abstract: Disease surveillance networks in the Middle East, Southeast Asia, and Africa are models for the kind of transnational cooperation that can mount the needed flexible and coordinated response to the spread of 2009 H1N1 influenza and future pandemic threats. For example, members of the Middle East Consortium on Infectious Disease Surveillance (MECIDS), a regional disease surveillance network of public health experts and ministry of health officials from Israel, the Palestinian Authority, and Jordan, have coordinated the screening, laboratory testing, and risk communication strategies to detect and control 2009 H1N1 influenza. This coordination is made possible by trust and by well-exercised national and regional pandemic preparedness policies. The consortium illustrates the value of regional disease surveillance networks in shaping and managing cohesive policies on current and future threats. The MECIDS alliance partnership also exemplifies to other parts of the world that are experiencing conflict—like Sout...

Exposure to Bioterrorism and Mental Health Response among Staff on Capitol Hill

Abstract: The October 2001 anthrax attacks heralded a new era of bioterrorism threat in the US 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

Billions for biodefense: federal agency biodefense funding, FY2009-FY2010.

Abstract: Since 2001, the United States government has spent substantial resources on preparing the nation against a bioterrorist attack. Earlier articles in this series analyzed civilian biodefense funding by the federal government for fiscal years (FY) 2001 through 2009. This article updates those figures with budgeted amounts for FY2010, specifically analyzing the budgets and allocations for biodefense at the Departments of Health and Human Services, Defense, Homeland Security, Agriculture, and State; the Environmental Protection Agency; and the National Science Foundation. This year's article also provides an assessment of the proportion of the biodefense budget that serves multiple programmatic goals and benefits, including research into infectious disease pathogenesis and immunology, public health planning and preparedness, and disaster response efforts. The FY2010 federal budget for civilian biodefense totals $6.05 billion. Of that total, $4.96 billion is budgeted for programs that serve multiple goals and provide manifold benefits.

Probabilistic risk analysis and bioterrorism risk.

Abstract: For more than 30 years, probabilistic risk analysis (PRA) has been a major tool for assessing risks and informing risk management decisions by government and businesses in areas as diverse as industrial safety, environmental protection, and medical decision making The more recent application of PRA to terrorism risk is new, however, and not uncontroversial, as evidenced by the commentary by Parnell and colleagues in the December 2008 issue of "Biosecurity and Bioterrorism" The National Research Council on Methodological Improvements to the Department of Homeland Security's Biological Agent Risk Analysis has argued that because of the adaptive nature of the terrorist adversary, alternative tools like decision trees, game theory, and agent-based modeling are needed to assess the risks of terrorist events and that probabilistic risk analysis is not valuable In this commentary, we take a broad view of PRA, including any probabilistic approach involving tools like event trees, fault trees, decision trees, and influence diagrams We make 2 points: (1) PRA is useful to quantify terrorism risk, and (2) event trees can help to decompose the universe of terrorism scenarios

Biosecurity policies at international life science journals.

Abstract: The prospect of bioterrorism has raised concerns about the potential abuse of scientific information for malign purposes and the pressure on scientific publishers to prevent the publication of "recipes" for weapons of mass destruction. Here we present the results of a survey of 28 major life science journals--20 English-language international journals and 3 Chinese and 5 Russian journals--with regard to their biosecurity policies and procedures. The survey addressed the extent to which life science journals have implemented biosecurity procedures in recent years, how authors and reviewers are advised about these procedures and the underlying concerns, and what the practical experiences have been. Few of the English-language publishers and none of the Russian and Chinese publishers surveyed implement formal biosecurity policies or inform their authors and reviewers about potentially sensitive issues in this area.

Source reduction in an anthrax-contaminated mail facility.

Abstract: Following the 2001 bioterrorist attacks using letters containing Bacillus anthracis spores, a number of sites had to be decontaminated. Source reduction—the process of reducing biocontamination levels prior to the main decontamination treatment—is a critical step in decontaminating buildings. Such activities include the removal of items from a facility either for off-site treatment and reuse or ultimate disposal, as well as the pretreatment of certain surfaces in the facility. In addition, waste disposal activities are initiated during the source reduction process and continued throughout the overall remediation process. This article presents the source reduction and waste disposal activities at the Department of State (DoS) Diplomatic Pouch and Mail Facility (SA-32) in Loudoun County, Virginia. At this facility, nearly all materials were removed before the fumigations with vaporized hydrogen peroxide. The materials that were removed from the site were divided into essential and nonessential items, and no...

Triage, Rationing, and Palliative Care in Disaster Planning

Abstract: In this issue of Biosecurity and Bioterrorism, Matzo and colleagues introduce the roles of palliative care in the response to catastrophic mass casualty events. This work is part of a larger effort supported by the Agency for Healthcare Research and Quality (AHRQ) to define and plan for the ‘‘altered standards of care’’ considered inevitable during a mass casualty event. Here we offer some additional perspective on a number of issues raised in their article. The authors and the AHRQ conferees are to be congratulated for their thoughtful deliberations and for disseminating their recommendations through the peerreviewed literature. We hope that publication of their work will both catalyze scholarly discourse on the subject and broaden the base of stakeholder input. Matzo and colleagues conclude that planning for the medical response to a mass casualty event should include provisions for palliative care surge capacity. The authors offer some creative ways to address this requirement, including developing Disaster Palliative Assistance Teams under the aegis of the Medical Reserve Corps or the National Disaster Medical System. Such teams could be specially trained and equipped to provide some level of palliative care under the demanding operational constraints of a mass casualty event response. These are valuable suggestions to planners at all jurisdictional tiers of response. Their assertion, however, that palliative care may ‘‘free up resources to optimize survival of others’’ is unproven and counterintuitive. The addition of a large number of patients rendered terminally ill or injured in a mass casualty event to the population of patients already receiving palliative care will certainly generate the need for palliative care surge capacity. Patients from a mass casualty event who will require some elements of palliative care include those who have been assigned to several different triage categories: (1) ‘‘expectant’’ patients, who are considered so unlikely to benefit from life-saving interventions that those interventions are not offered; (2) ‘‘immediate’’ patients, who could potentially survive with aggressive therapy, but limited medical or transportation resources render it temporarily unavailable; and (3) both ‘‘immediate’’ and ‘‘delayed’’ patients, who will eventually receive life-saving, definitive care but require supportive care, symptom control, and other comfort measures while waiting for it. Although the categories listed above are generally used in the field or emergency department triage of trauma victims who need surgical care, they can be readily correlated with patients requiring critical care during a pandemic. Different ethical principles inform management of the patients within these various triage categories. In the first, the availability or scarcity of resources has little bearing on whether attempts at curative therapy should be offered or provided. Palliative care is the only efficacious option for these patients, and the ethical principles relate primarily to proving that other therapeutic interventions would be futile. The second group faces rationing of potentially useful resources, and different ethical principles apply. It is the responsibility of planners and responders to minimize the size of this group through both prospective and real-time solutions to the challenges presented by various types of

The Four Faces of Microbial Forensics

Abstract: The emerging field of microbial forensics played a major role in the investigation of the 2001 anthrax mailings and has been closely associated with the process of attribution, or identifying the perpetrator of a biological attack for purposes of criminal prosecution or military retaliation. Nevertheless, microbial forensics has other potential applications in intelligence, nonproliferation, and verification. This article describes the relevance of microbial forensics for a variety of law enforcement and national security missions, examines the obstacles to its broader use, and concludes with some policy recommendations.

Triage and Management of Accidental Laboratory Exposures to Biosafety Level-3 and -4 Agents

Abstract: The recent expansion of biocontainment laboratory capacity in the United States has drawn attention to the possibility of occupational exposures to BSL-3 and -4 agents and has prompted a reassessment of medical management procedures and facilities to deal with these contingencies. A workshop hosted by the National Interagency Biodefense Campus was held in October 2007 and was attended by representatives of all existing and planned BSL-4 research facilities in the U.S. and Canada. This report summarizes important points of discussion and recommendations for future coordinated action, including guidelines for the engineering and operational controls appropriate for a hospital care and isolation unit. Recommendations pertained to initial management of exposures (ie, immediate treatment of penetrating injuries, reporting of exposures, initial evaluation, and triage). Isolation and medical care in a referral hospital (including minimum standards for isolation units), staff recruitment and training, and community outreach also were addressed. Workshop participants agreed that any unit designated for the isolation and treatment of laboratory employees accidentally infected with a BSL-3 or -4 pathogen should be designed to maximize the efficacy of patient care while minimizing the risk of transmission of infection. Further, participants concurred that there is no medically based rationale for building care and isolation units to standards approximating a BSL-4 laboratory. Instead, laboratory workers accidentally exposed to pathogens should be cared for in hospital isolation suites staffed by highly trained professionals following strict infection control procedures.

The legal landscape for school closures in response to pandemic flu or other public health threats.

Abstract: Together with other nonpharmaceutical interventions in response to pandemic influenza or other public health emergencies, communitywide closure of schools (grades K-12) for up to several weeks may mitigate the impacts of pandemic flu or other public health threats across populations. Though debatable, the public health premise is that closing schools could limit the spread of influenza (or other communicable conditions), consistent with social distancing theories. This presumes that laws support school closures for extended time periods during each wave of an influenza pandemic. However, government agencies and others have incomplete and inconsistent information about whether laws authorize long-term school closure for public health purposes in routine and emergency circumstances. As a result, the Centers for Law and the Public's Health: A Collaborative at Johns Hopkins and Georgetown Universities examined laws that expressly authorize school closure due to pandemic flu or other public health threats in 52 U.S. jurisdictions. While school closure is legally possible in most jurisdictions during routine and emergency circumstances, significant legal issues remain. When can schools be closed for public health purposes, and under what standards? Which levels and departments of government are actually responsible for closing schools? How does an emergency declaration affect government authority to close schools? This article explains the Center's study methodology, presents major findings on express laws allowing for school closure, and discusses legal issues underlying school closures during nonemergencies and declared emergencies.

Bacterial pneumonias during an influenza pandemic: How will we allocate antibiotics?

Abstract: We are currently in the midst of the 2009 H1N1 pandemic, and a second wave of flu in the fall and winter could lead to more hospitalizations for pneumonia. Recent pathologic and historic data from the 1918 influenza pandemic confirms that many, if not most, of the deaths in that pandemic were a result of secondary bacterial pneumonias. This means that a second wave of 2009 H1N1 pandemic influenza could result in a widespread shortage of antibiotics, making these medications a scarce resource. Recently, our University of Michigan Health System (UMHS) Scarce Resource Allocation Committee (SRAC) added antibiotics to a list of resources (including ventilators, antivirals, vaccines) that might become scarce during an influenza pandemic. In this article, we summarize the data on bacterial pneumonias during the 1918 influenza pandemic, discuss the possible impact of a pandemic on the University of Michigan Health System, and summarize our committee's guiding principles for allocating antibiotics during a pandemic.

Agriculture emergencies: a primer for first responders

Abstract: Over the past several years, the primary focus of emergency preparedness has been on terrorism, and how a CBRNE event would directly affect human health. Limited emphasis has been placed on the direct (eg, zoonotic infections) and indirect (eg, mental health, financial loss) effects that an agricultural emergency event can have on human health outcomes, and how they relate to emergency preparedness. We critically reviewed the resources and information readily accessible to our target audience, emergency responders; the resources included military and civilian books, personal communications, internet sites, GAO reports, and peer-reviewed journals. Among more than 2,000 bioterrorism-related articles, we found 51 that addressed either agroterrorism and/or veterinary public health: 2 cross-sectional studies, 28 review papers, and 21 commentary papers. In order to properly respond to future agriculture emergencies, emergency response professionals need to understand the nature and implications of the event as well as their roles and responsibilities, but the availability of educational and training opportunities is limited. The results of our review are consistent with the hypothesis that more resources, education, and training opportunities should be available to responders as well as to producers, importers and shippers, international travelers, and the general public. Increased education and training will raise awareness among these groups of the relationship between animal and human health.

PrepLink: a novel web-based tool for healthcare emergency planning and response.

Abstract: This article describes PrepLink, a comprehensive web-based healthcare-related all-hazards electronic disaster management system. The system includes pages for public awareness about planning for and responding to disasters and pages that can be used by many types of emergency and healthcare personnel involved in such events.

Emergency Use Authority and 2009 H1N1 influenza.

Abstract: This article discusses the steps that the Department of Health and Human Services follows to authorize emergency use of products under section 564 of the Federal Food, Drug and Cosmetic Act through Emergency Use Authorizations. We provide examples of when the department might authorize such emergency use and describe the products for which the department has authorized emergency use for the current H1N1 influenza pandemic as of September 1, 2009.

The "nuclearization" of biology is a threat to health and security.

Abstract: Every technology, from fire to gunpowder to aviation, has been used by humans largely for good but also for harm. But the capabilities of an individual or group to do great harm have increased markedly in the past 50 years. In the mid-20th century, we developed nuclear weapons, but these have remained in the hands of nation-states because it would be extraordinarily difficult for even a technically competent group of individuals to gain access to the singular ingredients—highly enriched uranium or reprocessed plutonium—and the technology to develop a nuclear weapon and thus cause incalculable harm and mass death. To date we have controlled the proliferation of nuclear weapons by safeguarding the rare elements needed to produce them and by carefully screening scientists and technicians for their physical and mental health. Today, only a few nation-states have the bomb, and there have been zero accidental or terrorist detonations. More recently, our understanding of biology and the means to utilize it have improved greatly. Indeed, we’ve seen a revolution in recombinant DNA technology, synthetic genomics, nanotechnology, and de novo synthesis of microbes, among many examples. These powerful tools and information are now found in secondary schools around the globe and in homes of do-it-yourself genetic engineers. Proliferation of the biotechnologies is essentially complete. In 1996, one ‘‘outlier biologist’’ attempted to acquire a common, but potentially lethal, pathogenic microbe from the American Type Culture Collection. In response, alarmed legislators called for an official list of ‘‘dangerous pathogens’’ and the registration of laboratories that exchanged those pathogens. As a result, in 1997, the ‘‘nuclear model’’ was applied to biology for the first time. Years later, a series of ‘‘anthrax letters’’ killed 5 individuals, frightened tens of thousands of people, and precipitated a significant degree of government and economic disorder, prompting scientists to increasingly engage in discussions of ‘‘dual-use biology’’—that is, biology that could be used for malevolent as well as benevolent purposes. Then, on July 28, 2008, a respected senior scientist at Ft. Detrick, Maryland, committed suicide just before the Department of Justice was to seek an indictment charging him with crimes having to do with the anthrax letters. Now, the U.S. government is once again looking to the nuclear model to further regulate biology. It is worth pausing to reflect whether this is a wise strategy, given the dichotomy between the nuclear and biological threats. The

The Danger of Declining Funds: Public Health Preparedness in NYC

Abstract: Since 2001, the New York City Department of Health and Mental Hygiene (NYC DOHMH) has built a strong public health preparedness foundation, made possible in large part by funding from the Public Health Emergency Preparedness (PHEP) Cooperative Agreement provided by the Centers for Disease Control and Prevention. While this funding has allowed NYC DOHMH to make great progress in areas such as all-hazards planning, risk communication, disease surveillance, and lab capacity, the erosion of federal preparedness dollars for all-hazards preparedness has the potential to reverse these gains. Since the initiation of the PHEP grant in 2002, PHEP funding has steadily declined nationwide. Specifically, the total federal allocation has decreased approximately 20%, from $862,777,000 in 2005 to $688,914,546 in 2009. With city and state budgets at an all-time low, federal funding cuts will have a significant impact on public health preparedness programs nationwide. In this time of strict budgetary constraints, the nation would be better served by strategically awarding federal preparedness funds to areas at greatest risk. The absence of risk-based funding in determining PHEP grant awards leaves the nation's highest-risk areas, like New York City, with insufficient resources to prepare for and respond to public health emergencies. This article examines the progress New York City has made and what is at stake as federal funding continues to wane.

Federal declaration of a public health emergency.

Abstract: During certain emergencies (naturally caused or deliberate) that can have a significant impact on the public's health, the Secretary of the U.S. Department of Health and Human Services (HHS) has broad discretion to declare a Public Health Emergency (PHE). While many public health emergencies will not require a formal declaration, this type of declaration can be an important and necessary step to authorize the secretary to take a variety of actions that enable the department to respond optimally to an emergency. This article outlines the HHS Secretary's PHE authority, discusses possible discretionary actions that the secretary may take after declaring a PHE, and provides examples of PHE declarations that have been issued.