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The Acquisition of Drugs and Biologics for Chemical and Biological Warfare Defense. Department of Defense Interactions with the Food and Drug Administration

The Acquisition of Drugs and Biologics for Chemical and Biological Warfare Defense. Department of Defense Interactions with the Food and Drug Administration
Author:
Publisher:
Total Pages: 94
Release: 2003
Genre:
ISBN:

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Chemical and biological threats confront U.S. military personnel today both overseas and in the continental United States, whether in defensive, peacekeeping, or offensive situations. Defenses against such threats are both medical and nonmedical. Drugs and biologics, mainly vaccines, constitute the primary medical defenses. Consequently, efforts of the U.S. Department of Defense (DoD) to protect American troops require the acquisition of drugs and biologics for chemical and biological warfare (CBW) defense. The objective of this acquisition, as is the case for other acquisitions, is to obtain the desired supply of a given product at an acceptable price. This study includes both drugs and biologics, but it emphasizes the latter (mainly focusing on vaccines, a subset of biologics). Vaccines provide advanced protection against biological warfare threats via immunization of at-risk troops and prior protection is a high priority within DoD. In contrast, drugs are useful mainly in treating already-exposed troops. Vaccine development is also more complicated than drug development because it typically involves manipulating live organisms, whereas drugs consist of more-stable chemical entities. DoD has two distinct roles during the acquisition of drugs and biologics for CBW defense: purchaser and developer. As purchaser of a drug approved by the U.S. Food and Drug Administration (FDA) for which a commercial market exists, DoD simply buys what it needs at the market price; DoD acquisition of influenza vaccine is a good example of this.


The Acquisition of Drugs and Biologics for Chemical and Biological Warfare Defense

The Acquisition of Drugs and Biologics for Chemical and Biological Warfare Defense
Author: Richard A. Rettig
Publisher: Rand Corporation
Total Pages: 77
Release: 2003
Genre: History
ISBN: 9780833034502

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The 1990-1991 Gulf War made clear the U.S. Department of Defense's (DoD's) need to effectively acquire drugs and biologics, mainly vaccines, as American troops faced the real threat of chemical and biological warfare (CBW) agents being used in combat. More than a decade after the war, DoD still experiences acute obstacles in obtaining CBW defense supplies. In response, the authors look at the department's relationship with the U.S. Food and Drug Administration (FDA) and suggest ways to improve it through such means as centralizing the department's acquisition authority and further educating DoD personnel.


Strategies to Protect the Health of Deployed U.S. Forces

Strategies to Protect the Health of Deployed U.S. Forces
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 297
Release: 1999-01-01
Genre: Medical
ISBN: 0309172527

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Nine years after Operations Desert Shield and Desert Storm (the Gulf War) ended in June 1991, uncertainty and questions remain about illnesses reported in a substantial percentage of the 697,000 service members who were deployed. Even though it was a short conflict with very few battle casualties or immediately recognized disease or non-battle injuries, the events of the Gulf War and the experiences of the ensuing years have made clear many potentially instructive aspects of the deployment and its hazards. Since the Gulf War, several other large deployments have also occurred, including deployments to Haiti and Somalia. Major deployments to Bosnia, Southwest Asia, and, most recently, Kosovo are ongoing as this report is written. This report draws on lessons learned from some of these deployments to consider strategies to protect the health of troops in future deployments. In the spring of 1996, Deputy Secretary of Defense John White met with leadership of the National Research Council and the Institute of Medicine to explore the prospect of an independent, proactive effort to learn from lessons of the Gulf War and to develop a strategy to better protect the health of troops in future deployments.


Strategies to Protect the Health of Deployed U.S. Forces

Strategies to Protect the Health of Deployed U.S. Forces
Author: National Research Council
Publisher: National Academies Press
Total Pages: 388
Release: 2000-03-17
Genre: Medical
ISBN: 0309172535

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Risk management is especially important for military forces deployed in hostile and/or chemically contaminated environments, and on-line or rapid turn-around capabilities for assessing exposures can create viable options for preventing or minimizing incapaciting exposures or latent disease or disability in the years after the deployment. With military support for the development, testing, and validation of state-of-the-art personal and area sensors, telecommunications, and data management resources, the DOD can enhance its capabilities for meeting its novel and challenging tasks and create technologies that will find widespread civilian uses. Strategies to Protect the Health of Deployed U.S. Forces assesses currently available options and technologies for productive pre-deployment environmental surveillance, exposure surveillance during deployments, and retrospective exposure surveillance post-deployment. This report also considers some opportunities for technological and operational advancements in technology for more effective exposure surveillance and effects management options for force deployments in future years.


Toxicologic Assessment of the Army's Zinc Cadmium Sulfide Dispersion Tests

Toxicologic Assessment of the Army's Zinc Cadmium Sulfide Dispersion Tests
Author: National Research Council
Publisher: National Academies Press
Total Pages: 387
Release: 1997-06-30
Genre: Nature
ISBN: 0309057833

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During the 1950s and 1960s, the U.S. Army conducted atmospheric dispersion tests in many American cities using fluorescent particles of zinc cadmium sulfide (ZnCdS) to develop and verify meteorological models to estimate the dispersal of aerosols. Upon learning of the tests, many citizens and some public health officials in the affected cities raised concerns about the health consequences of the tests. This book assesses the public health effects of the Army's tests, including the toxicity of ZnCdS, the toxicity of surrogate cadmium compounds, the environmental fate of ZnCdS, the extent of public exposures from the dispersion tests, and the risks of such exposures.


The Irritable Heart

The Irritable Heart
Author: Jeff Wheelwright
Publisher: W. W. Norton & Company
Total Pages: 444
Release: 2001
Genre: Case studies
ISBN: 9780393019568

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Wheelwright (former science editor for Life magazine) profiles five ailing Gulf War veterans from their deployment to the Gulf, through their experiences in the Gulf War, and their subsequent illnesses and attempts to discover the causes. He argues that the illnesses belong in the company of chronic fatigue syndrome, fibromyalgia, and multiple chemical sensitivity. Pointing out precedents in military history that go back as far as a Civil War malady known as "irritable heart," he argues that the illnesses are a combination of physical symptoms greatly magnified by psychological distress. Because modern medicine deals with the body and mind separately, he contends, the health investigation of the veteran's illnesses is bound to fail. Annotation copyrighted by Book News Inc., Portland, OR


Gulf War Illness and the Health of Gulf War Veterans

Gulf War Illness and the Health of Gulf War Veterans
Author: United States. Department of Veterans Affairs. Research Advisory Committee on Gulf War Veterans' Illnesses
Publisher:
Total Pages: 468
Release: 2008
Genre: Government publications
ISBN:

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Questions surrounding Gulf War illness and other health problems resulting from service in the 1990-1991 Gulf War have long plagued veterans and government officials. This 450-page report brings together for the first time the full range of scientific research and government investigations on Gulf War illness. The comprehensive analysis resolves many questions about what caused Gulf War illness and what should be done to address this serious condition, which affects at least one in four Gulf War veterans.--Publisher description.