Military Use Of Drugs Not Yet Approved By The Fda For Cw Bw Defense
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Author | : Richard A. Rettig |
Publisher | : Minnesota Historical Society |
Total Pages | : 128 |
Release | : 1999 |
Genre | : Business & Economics |
ISBN | : 9780833026835 |
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.
Author | : |
Publisher | : |
Total Pages | : 118 |
Release | : 1998 |
Genre | : |
ISBN | : |
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.
Author | : Richard A. Rettig |
Publisher | : RAND Corporation |
Total Pages | : 0 |
Release | : 1999 |
Genre | : History |
ISBN | : 9780585245478 |
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.
Author | : Richard M. Heames |
Publisher | : BRILL |
Total Pages | : 190 |
Release | : 2023-12-18 |
Genre | : Law |
ISBN | : 9004677747 |
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.
Author | : Michael L. Gross |
Publisher | : Oxford University Press |
Total Pages | : 353 |
Release | : 2021 |
Genre | : Medical |
ISBN | : 0190694947 |
"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"--
Author | : Institute of Medicine |
Publisher | : National Academies Press |
Total Pages | : 297 |
Release | : 1999-02-01 |
Genre | : Medical |
ISBN | : 0309066379 |
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.
Author | : |
Publisher | : DIANE Publishing |
Total Pages | : 52 |
Release | : 2001 |
Genre | : |
ISBN | : 1428946616 |
Author | : United States. General Accounting Office |
Publisher | : |
Total Pages | : 56 |
Release | : 2001 |
Genre | : Biological warfare |
ISBN | : |
Author | : National Research Council |
Publisher | : National Academies Press |
Total Pages | : 161 |
Release | : 2004-05-06 |
Genre | : Political Science |
ISBN | : 0309091535 |
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.
Author | : Jeff Wheelwright |
Publisher | : W. W. Norton & Company |
Total Pages | : 444 |
Release | : 2001 |
Genre | : History |
ISBN | : 9780393019568 |
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