Download or read book Military Use of Drugs Not Yet Approved by the FDA for CW BW Defense written by Richard A. Rettig and published by Minnesota Historical Society. This book was released on 1999 with total page 128 pages. Available in PDF, EPUB and Kindle. Book excerpt: The confrontation that began when Iraq invaded Kuwait in August 1990 brought with it the threat that chemical and biological weapons might be used against the more than half a million military personnel the United States deployed to the region. To protect these troops from such threats, the Department of Defense wished to use drugs and vaccines that, not having been tested for use in these specific situations, were considered "investigational" by the federal Food and Drug Administration. This report examines the history of the Interim Rule, adopted in December 21, 1990, that authorized the Commissioner of Food and Drugs to waive informed consent for the use of investigational drugs and vaccines for certain military uses; how this authority was used for pyridostigmine bromide and botulinum toxoid during the Gulf War; and the subsequent controversy surrounding the rule, its application, and its implications. The report then analyzes the issues the Interim Rule raised when investigational drugs are used for such purposes and makes recommendations for dealing with similar situations in the future.
Download or read book Military Use of Drugs Not Yet Approved by the FDA for CW BW Defense written by Richard A. Rettig and published by RAND Corporation. This book was released on 1999 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report is one of several commissioned by the Special Assistant to the Deputy Secretary of Defense for Gulf War Illnesses. It deals with the Interim Rule, adopted in December 1990, which established the authority of the Commissioner of Food and Drugs to waive informed consent for using investigational drugs in certain military contingencies. The contingency for which it was adopted and in which it was used was the 1991 Gulf War, when U.S. and coalition forces confronted the possibility of chemical and biological weapons being used by the Iraqi military. The investigational drugs in question were pyridostigmine bromide and botulinum toxoid vaccine. --p. v of Preface.
Download or read book Military Use of Drugs Not Yet Approved by the FDA for CW BW Defense Lessons from the Gulf War written by and published by . This book was released on 1998 with total page 118 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report is one of several commissioned by the Special Assistant to the Deputy Secretary of Defense for Gulf War Illnesses. It deals with the Interim Rule, adopted in December 1990, which established the authority of the Commissioner of Food and Drugs to waive informed consent for using investigational drugs in certain military contingencies. The contingency for which it was adopted and in which it was used was the 1991 Gulf War, when U.S. and coalition forces confronted the possibility of chemical and biological weapons being used by the Iraqi military. The investigational drugs in question were pyridostigmine bromide and botulinum toxoid vaccine.
Download or read book Waiving Informed Consent written by and published by . This book was released on 2000 with total page 2 pages. Available in PDF, EPUB and Kindle. Book excerpt: Summary of: Military use of drugs not yet approved by the FDA for CW/BW defense : lessons from the Gulf War / by Richard A. Rettig.
Download or read book Pharmacological Enhancements in the Military written by Richard M. Heames and published by BRILL. This book was released on 2023-12-18 with total page 190 pages. Available in PDF, EPUB and Kindle. Book excerpt: Human enhancement is a rapidly advancing field and the speed of advance of technology, from being available to being used, results in a delay to the ethics surrounding it. This is true of pharmacological enhancement (PCE) as much as exoskeletons and human-machine interfacing. Ethical issues arising from human enhancement include autonomy, safety and dignity. The first two are the cornerstones of the ethics surrounding informed consent (IC) which emanated from the necessity to protect human subjects against the risks of research. What remains unclear is how those risks are quantified, who decides whether the risk is an acceptable one and whether IC is required. This volume explores all these legal and ethical issues, including the theory and history of IC and the role of military doctors.
Download or read book Military Medical Ethics in Contemporary Armed Conflict written by Michael L. Gross and published by Oxford University Press. This book was released on 2021 with total page 353 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The goal of military medicine is to conserve the fighting force necessary to prosecute just wars. Just wars are defensive or humanitarian. A defensive war protects one's people or nation. A humanitarian war rescues a foreign, persecuted people or nation from grave human rights abuse. To provide medical care during armed conflict, military medical ethics supplements civilian medical ethics with two principles: military-medical necessity and broad beneficence. Military-medical necessity designates the medical means required to pursue national self-defense or humanitarian intervention. While clinical-medical necessity directs care to satisfy urgent medical needs, military-medical necessity utilizes medical care to satisfy the just aims of war. Military medicine may therefore attend the lightly wounded before the critically wounded or use medical care to win hearts and minds. The underlying principle is broad, not narrow, beneficence. The latter addresses private interests, while broad beneficence responds to the collective welfare of the political community"--
Download or read book Coalition warfare Gulf War allies differed in chemical and biological threats identified and in use of defensive measures written by and published by DIANE Publishing. This book was released on 2001 with total page 52 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Strategies to Protect the Health of Deployed U S Forces written by Institute of Medicine and published by National Academies Press. This book was released on 1999-02-01 with total page 297 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Giving Full Measure to Countermeasures written by National Research Council and published by National Academies Press. This book was released on 2004-05-06 with total page 161 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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. According to a new congressionally mandated report from the Institute of Medicine and National Research Council of the National Academies, to successfully develop these drugs, vaccines, and other medical interventions against biowarfare agents, Congress should authorize the creation of a new agency within the Office of the Secretary of the U.S. Department of Defense. The committee recommended that Congress should improve liability protections for those who develop and manufacture these products, to stimulate willingness to invest in new research and development for biowarfare protection. Giving Full Measure to Countermeasures also identifies other challengesâ€"such as the need for appropriate animal models and laboratories equipped with high-level biosafety protectionsâ€"that will require attention if DoD efforts to develop new medical countermeasures are to be successful.
Download or read book Coalition Warfare written by United States. General Accounting Office and published by . This book was released on 2001 with total page 56 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Irritable Heart written by Jeff Wheelwright and published by W. W. Norton & Company. This book was released on 2001 with total page 444 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book The Food and Drug Administration Confronts Homeland and National Security written by Richard A. Rettig and published by . This book was released on 2003 with total page 14 pages. Available in PDF, EPUB and Kindle. Book excerpt: Reviews a RAND workshop (Dec. 2002) on challenges faced by the U.S. Food and Drug Administration in the agency's potential response to increased national and homeland security needs for drugs and vaccines.
Download or read book The Implications of the U S Department of Veterans Affairs Limited Scope of Gulf War Illness Research written by United States. Congress. House. Committee on Veterans' Affairs. Subcommittee on Oversight and Investigations and published by . This book was released on 2010 with total page 140 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Animal Models for Assessing Countermeasures to Bioterrorism Agents written by National Research Council and published by National Academies Press. This book was released on 2012-01-09 with total page 152 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Transformational Medical Technologies (TMT) has been a unique component of the U.S. Department of Defense (DoD) medical biodefense efforts since 2006. Its mission is to advance countermeasure research and development in support of the broader goal of the DoD to protect warfighters from emerging infectious diseases and future genetically engineered biological weapons. The TMT, using advanced science and technology approaches, focused on the development of roadspectrum countermeasures that target common host and pathogen pathways or enhance the host's immune response. Many of these pathogens are lethal or cause such debilitating diseases in humans that it is ethically inappropriate to test the efficacy of these countermeasures in human volunteers. In lieu of human participants, these products may be tested in animals and approved for human use under the provisions of the Food and Drug Administration (FDA)'s 2002 Animal Rule. The reliance on animal models for the development and licensure of medical countermeasures against biothreats is challenging for a number of reasons. The ad hoc Committee on Animal Models for Assessing Countermeasures to Bioterrorism Agents prepared a consensus report that would address the challenges stemming from developing and testing medical countermeasures against biothreat agents in animal models. Animal Models for Assessing Countermeasures to Bioterrorism Agents evaluates how well the existing TMT-employed or candidate animal models reflect the pathophysiology, clinical picture, and treatment of human disease as related to the agents of interest. The report addresses the process and/or feasibility of developing new animal models for critical biodefense research, placing emphasis on the need for a robust and expeditious validation process in terms of the FDA's Animal Rule. The report also evaluates alternatives to the use of animal models based on the premise of the Three Rs.
Download or read book Army Medical Support to the Army After Next written by Gary Cecchine and published by RAND Corporation. This book was released on 2001 with total page 114 pages. Available in PDF, EPUB and Kindle. Book excerpt: This weeklong workshop focused primarily on identifying those portions of the Army's Medical Science and Technology Investment Strategy, principally Basic Research (6.1) and Applied Research (6.2) investment areas, that are essential to ensure that the Army will have the required medical capabilities to support the Army After Next (AAN) in 2025. The goal of the Medical Technology Workshop 1999 (MTW-99) was to support Army efforts to make the appropriate technology acquisition decisions by developing medical solutions for military requirements to protect and sustain the force.
Download or read book Bioethics and Armed Conflict written by Michael Gross and published by MIT Press. This book was released on 2006-06-16 with total page 401 pages. Available in PDF, EPUB and Kindle. Book excerpt: Is medical ethics in times of armed conflict identical to medical ethics in times of peace, as the World Medical Association declares? In Bioethics and Armed Conflict, the first comprehensive study of medical ethics in conventional, unconventional, and low-intensity war, Michael Gross examines the dilemmas that arise when bioethical principles clash with military necessity—when physicians try to save lives during an endeavor dedicated to taking them—and describes both the conflicts and congruencies of military and medical ethics. Gross describes how the principles of contemporary just war, unlike those of medical ethics, often go beyond the welfare of the individual to consider the collective interests of combatants and noncombatants and the general interests of the state. Military necessity plays havoc with such patients' rights as the right to life, the right to medical care, informed consent, confidentiality, and the right to die. The principles of triage in battle conditions dictate not need-based treatment but the distribution of resources that will return the greatest number of soldiers to active duty. And unconventional warfare, including current "wars" on terrorism, challenges the traditional concept of medical neutrality as physicians who have sworn to "do no harm" are called upon to lend their expertise to "interrogational" torture or to the development of biological or chemical weapons. Difficult dilemmas inevitably arise during armed conflict, and medicine, Gross concludes, is not above the fray. Medical ethics in time of war cannot be identical to medical ethics in peacetime.
Download or read book Contested Illnesses written by Phil Brown and published by Univ of California Press. This book was released on 2011-12-26 with total page 342 pages. Available in PDF, EPUB and Kindle. Book excerpt: The politics and science of health and disease remain contested terrain among scientists, health practitioners, policy makers, industry, communities, and the public. Stakeholders in disputes about illnesses or conditions disagree over their fundamental causes as well as how they should be treated and prevented. This thought-provoking book crosses disciplinary boundaries by engaging with both public health policy and social science, asserting that science, activism, and policy are not separate issues and showing how the contribution of environmental factors in disease is often overlooked.
