Military Use of Drugs Not Yet Approved by the FDA for CW/BW Defense

Military Use of Drugs Not Yet Approved by the FDA for CW/BW Defense
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.

Military Use of Drugs Not Yet Approved by the FDA for CW/BW Defense. Lessons from the Gulf War

Military Use of Drugs Not Yet Approved by the FDA for CW/BW Defense. Lessons from the Gulf War
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.

Military Use of Drugs Not Yet Approved by the FDA for CW/BW Defense

Military Use of Drugs Not Yet Approved by the FDA for CW/BW Defense
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.

Pharmacological Enhancements in the Military

Pharmacological Enhancements in the Military
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.

Military Medical Ethics in Contemporary Armed Conflict

Military Medical Ethics in Contemporary Armed Conflict
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"--

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: 1999-02-01
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.

Coalition Warfare

Coalition Warfare
Author: United States. General Accounting Office
Publisher:
Total Pages: 56
Release: 2001
Genre: Biological warfare
ISBN:

Giving Full Measure to Countermeasures

Giving Full Measure to Countermeasures
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.

The Irritable Heart

The Irritable Heart
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