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At the turn of the twenty-first century, the United States contended with a state-run biological warfare program, bioterrorism, and a pandemic. Together, these threats spurred large-scale government demand for new vaccines, but few have materialized. A new anthrax vaccine has been a priority since the first Gulf War, but twenty years and a billion dollars later, the United States still does not have one. This failure is startling. Historically, the United States has excelled at responding to national health emergencies. World War II era programs developed ten new or improved vaccines, often in time to meet the objectives of particular military missions. Probing the history of vaccine development for factors that foster timely innovation, Kendall Hoyt discovered that vaccine innovation has been falling, not rising, since World War II. This finding is at odds with prevailing theories of market-based innovation and suggests that a collection of nonmarket factors drove mid-century innovation. Ironically, many late-twentieth-century developments that have been celebrated as a boon for innovation—the birth of a biotechnology industry and the rise of specialization and outsourcing—undercut the collaborative networks and research practices that drove successful vaccine projects in the past. Hoyt's timely investigation teaches important lessons for our efforts to rebuild twenty-first-century biodefense capabilities, especially when the financial payback for a particular vaccine is low, but the social returns are high.

The BioWatch program, funded and overseen by the Department of Homeland Security (DHS), has three main elements-sampling, analysis, and response-each coordinated by different agencies. The Environmental Protection Agency maintains the sampling component, the sensors that collect airborne particles. The Centers for Disease Control and Prevention coordinates analysis and laboratory testing of the samples, though testing is actually carried out in state and local public health laboratories. Local jurisdictions are responsible for the public health response to positive findings. The Federal Bureau of Investigation is designated as the lead agency for the law enforcement response if a bioterrorism event is detected. In 2003 DHS deployed the first generation of BioWatch air samplers. The current version of this technology, referred to as Generation 2.0, requires daily manual collection and testing of air filters from each monitor. DHS has also considered newer automated technologies (Generation 2.5 and Generation 3.0) which have the potential to produce results more quickly, at a lower cost, and for a greater number of threat agents. Technologies to Enable Autonomous Detection for BioWatch is the summary of a workshop hosted jointly by the Institute of Medicine and the National Research Council in June 2013 to explore alternative cost-effective systems that would meet the requirements for a BioWatch Generation 3.0 autonomous detection system, or autonomous detector, for aerosolized agents . The workshop discussions and presentations focused on examination of the use of four classes of technologies-nucleic acid signatures, protein signatures, genomic sequencing, and mass spectrometry-that could reach Technology Readiness Level (TRL) 6-plus in which the technology has been validated and is ready to be tested in a relevant environment over three different tiers of temporal timeframes: those technologies that could be TRL 6-plus ready as part of an integrated system by 2016, those that are likely to be ready in the period 2016 to 2020, and those are not likely to be ready until after 2020. Technologies to Enable Autonomous Detection for BioWatch discusses the history of the BioWatch program, the role of public health officials and laboratorians in the interpretation of BioWatch data and the information that is needed from a system for effective decision making, and the current state of the art of four families of technology for the BioWatch program. This report explores how the technologies discussed might be strategically combined or deployed to optimize their contributions to an effective environmental detection capability.

The Department of Homeland Security's (DHS's) BioWatch program aims to provide an early indication of an aerosolized biological weapon attack. The first generation of BioWatch air samplers were deployed in 2003. The current version of this technology, referred to as Generation 2 (Gen-2), uses daily manual collection and testing of air filters from each monitor, a process that can take 12 to 36 hours to detect the presence of biological pathogens. Until April 2014, DHS pursued a next-generation autonomous detection technology that aimed to shorten the time from sample collection to detection to less than 6 hours, reduce the cost of analysis, and increase the number of detectable biological pathogens. Because of concerns about the cost and effectiveness of the proposed Generation 3 system (Gen-3), DHS cancelled its acquisition plans for the next-generation surveillance system. In response to the cancellation announcement, Congress asked the Government Accountability Office (GAO) to conduct a review of the program and the proposed system enhancements that would have been incorporated in BioWatch Gen-3. However, Mike Walter, BioWatch Program manager, Office of Health Affairs, DHS, said that DHS did not agree with all of GAO's characterizations of the BioWatch program efforts described in this review. In response to this, DHS requested that the National Academies of Sciences, Engineering, and Medicine conduct a workshop to further explore the findings of the 2015 GAO report and discuss the impact these findings may have with regard to the future development of the technical capabilities of the BioWatch program. Workshop participants also discussed existing and possible collaborations between BioWatch, public health laboratories, and other stakeholders that could contribute to the enhancement of biosurveillance capabilities at the federal, state, and local levels. This publication summarizes the presentations and discussions from the workshop.

[ Barriers to Bioweapons ] is a must-read for nonproliferation experts and should be a standard text for understanding biological weapons development for some time to come. ―David W. Kearn, Perspectives on Politics In both the popular imagination and among lawmakers and national security experts, there exists the belief that with sufficient motivation and material resources, states or terrorist groups can produce bioweapons easily, cheaply, and successfully. In Barriers to Bioweapons , Sonia Ben Ouagrham-Gormley challenges this perception by showing that bioweapons development is a difficult, protracted, and expensive endeavor, rarely achieving the expected results whatever the magnitude of investment. Her findings are based on extensive interviews she conducted with former U.S. and Soviet-era bioweapons scientists and on careful analysis of archival data and other historical documents related to various state and terrorist bioweapons programs. Bioweapons development relies on living organisms that are sensitive to their environment and handling conditions, and therefore behave unpredictably. These features place a greater premium on specialized knowledge. Ben Ouagrham-Gormley posits that lack of access to such intellectual capital constitutes the greatest barrier to the making of bioweapons. She integrates theories drawn from economics, the sociology of science, organization, and management with her empirical research. The resulting theoretical framework rests on the idea that the pace and success of a bioweapons development program can be measured by its ability to ensure the creation and transfer of scientific and technical knowledge. The specific organizational, managerial, social, political, and economic conditions necessary for success are difficult to achieve, particularly in covert programs where the need to prevent detection imposes managerial and organizational conditions that conflict with knowledge production. In both the popular imagination and among lawmakers and national security experts, there exists the belief that with sufficient motivation and material resources, states or terrorist groups can produce bioweapons easily, cheaply, and successfully. In Barriers to Bioweapons , Sonia Ben Ouagrham-Gormley challenges this perception by showing that bioweapons development is a difficult, protracted, and expensive endeavor, rarely achieving the expected results whatever the magnitude of investment. Her findings are based on extensive interviews she conducted with former U.S. and Soviet-era bioweapons scientists and on careful analysis of archival data and other historical documents related to various state and terrorist bioweapons programs.Bioweapons development relies on living organisms that are sensitive to their environment and handling conditions, and therefore behave unpredictably. These features place a greater premium on specialized knowledge. Ben Ouagrham-Gormley posits that lack of access to such intellectual capital constitutes the greatest barrier to the making of bioweapons. She integrates theories drawn from economics, the sociology of science, organization, and management with her empirical research. The resulting theoretical framework rests on the idea that the pace and success of a bioweapons development program can be measured by its ability to ensure the creation and transfer of scientific and technical knowledge. The specific organizational, managerial, social, political, and economic conditions necessary for success are difficult to achieve, particularly in covert programs where the need to prevent detection imposes managerial and organizational conditions that conflict with knowledge production.

ObjectiveWe aimed to characterise self-reported military and occupational exposures including Agent Orange, chemical/biological warfare agents, solvents, fuels, pesticides, metals and burn pits among Veterans in the Department of Veterans Affairs Million Veteran Program (MVP).MethodsMVP is an ongoing longitudinal cohort and mega-biobank of over one million US Veterans. Over 500 000 MVP participants reported military exposures on the baseline survey, and over 300 000 reported occupational exposures on the lifestyle survey. We determined frequencies of selected self-reported occupational exposures by service era, specific deployment operation (1990–1991 Gulf War, Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF)), service in a combat zone and occupational categories. We also explored differences in self-reported exposures by sex and race.ResultsAgent Orange exposure was mainly reported by Vietnam-era Veterans. Gulf War and OEF/OIF Veterans deployed to a combat zone were more likely to report exposures to burn pits, chemical/biological weapons, anthrax vaccination and pyridostigmine bromide pill intake as compared with non-combat deployers and those not deployed. Occupational categories related to combat (infantry, combat engineer and helicopter pilot) often had the highest percentages of self-reported exposures, whereas those in healthcare-related occupations (dentists, physicians and occupational therapists) tended to report exposures much less often. Self-reported exposures also varied by race and sex.ConclusionsOur results demonstrate that the distribution of self-reported exposures varied by service era, demographics, deployment, combat experience and military occupation in MVP. Overall, the pattern of findings was consistent with previous population-based studies of US military Veterans.

The rapid development of effective medical countermeasures against potential biological threat agents is vital. Repurposing existing drugs that may have unanticipated activities as potential countermeasures is one way to meet this important goal, since currently approved drugs already have well-established safety and pharmacokinetic profiles in patients, as well as manufacturing and distribution networks. Therefore, approved drugs could rapidly be made available for a new indication in an emergency. A large systematic effort to determine whether existing drugs can be used against high containment bacterial and viral pathogens is described. We assembled and screened 1012 FDA-approved drugs for off-label broad-spectrum efficacy against Bacillus anthracis; Francisella tularensis; Coxiella burnetii; and Ebola, Marburg, and Lassa fever viruses using in vitro cell culture assays. We found a variety of hits against two or more of these biological threat pathogens, which were validated in secondary assays. As expected, antibiotic compounds were highly active against bacterial agents, but we did not identify any non-antibiotic compounds with broad-spectrum antibacterial activity. Lomefloxacin and erythromycin were found to be the most potent compounds in vivo protecting mice against Bacillus anthracis challenge. While multiple virus-specific inhibitors were identified, the most noteworthy antiviral compound identified was chloroquine, which disrupted entry and replication of two or more viruses in vitro and protected mice against Ebola virus challenge in vivo. The feasibility of repurposing existing drugs to face novel threats is demonstrated and this represents the first effort to apply this approach to high containment bacteria and viruses.

In recent years, substantial efforts have been initiated to develop new drugs, vaccines, and other medical interventions against biological agents that could be used in bioterrorist attacks against civilian populations.

In Behind the Gas Mask, Thomas Faith offers an institutional history of the Chemical Warfare Service, the department tasked with improving the Army's ability to use and defend against chemical weapons during and after World War One. Taking the CWS's story from the trenches to peacetime, he explores how the CWS's work on chemical warfare continued through the 1920s despite deep opposition to the weapons in both military and civilian circles. As Faith shows, the believers in chemical weapons staffing the CWS allied with supporters in the military, government, and private industry to lobby to add chemical warfare to the country's permanent arsenal. Their argument: poison gas represented an advanced and even humane tool in modern war, while its applications for pest control and crowd control made a chemical capacity relevant in peacetime. But conflict with those aligned against chemical warfare forced the CWS to fight for its institutional life--and ultimately led to the U.S. military's rejection of battlefield chemical weapons.

As the public increasingly questioned the war in Vietnam, a group of American scientists deeply concerned about the use of Agent Orange and other herbicides started a movement to ban what they called \"ecocide.\" David Zierler traces this movement, starting in the 1940s, when weed killer was developed in agricultural circles and theories of counterinsurgency were studied by the military. These two trajectories converged in 1961 with Operation Ranch Hand, the joint U.S.-South Vietnamese mission to use herbicidal warfare as a means to defoliate large areas of enemy territory. Driven by the idea that humans were altering the world's ecology for the worse, a group of scientists relentlessly challenged Pentagon assurances of safety, citing possible long-term environmental and health effects. It wasn't until 1970 that the scientists gained access to sprayed zones confirming that a major ecological disaster had occurred. Their findings convinced the U.S. government to renounce first use of herbicides in future wars and, Zierler argues, fundamentally reoriented thinking about warfare and environmental security in the next forty years. Incorporating in-depth interviews, unique archival collections, and recently declassified national security documents, Zierler examines the movement to ban ecocide as it played out amid the rise of a global environmental consciousness and growing disillusionment with the containment policies of the cold war era.