Coverart for item
The Resource Military use of drugs not yet approved by the FDA for CW/BW defense : lessons from the Gulf War, Richard A. Rettig

Military use of drugs not yet approved by the FDA for CW/BW defense : lessons from the Gulf War, Richard A. Rettig

Label
Military use of drugs not yet approved by the FDA for CW/BW defense : lessons from the Gulf War
Title
Military use of drugs not yet approved by the FDA for CW/BW defense
Title remainder
lessons from the Gulf War
Statement of responsibility
Richard A. Rettig
Creator
Contributor
Subject
Language
eng
Summary
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
Member of
http://library.link/vocab/creatorName
Rettig, Richard A
Dewey number
358/.34
Index
no index present
Literary form
non fiction
Nature of contents
  • dictionaries
  • bibliography
http://library.link/vocab/relatedWorkOrContributorName
  • United States
  • National Defense Research Institute (U.S.)
Series statement
Gulf War illnesses series
http://library.link/vocab/subjectName
  • Chemical warfare
  • Biological warfare
  • Gases, Asphyxiating and poisonous
  • Vaccines
  • Informed consent (Medical law)
  • Involuntary treatment
  • United States
  • Persian Gulf War, 1991
  • Middle East
  • United States
Label
Military use of drugs not yet approved by the FDA for CW/BW defense : lessons from the Gulf War, Richard A. Rettig
Instantiates
Publication
Note
  • "Prepared for the Office of the Secretary of Defense, National Defense Research Institute."
  • "MR-1018-9-OSD"--Page 4 of cover
Bibliography note
Includes bibliographical references (pages 99-102)
Color
multicolored
Contents
Ch. 1. Introduction -- Purpose and Organization -- Background -- The Issues -- The Text of the Interim Rule -- Ch. 2. The History of the Interim Rule -- The Memorandum of Understanding Between DoD and FDA -- Careful Deliberations: 1990 -- Litigation: 1991 -- Actual Gulf War Experience with PB, BT and AX -- The Presidential Advisory Committee -- Ch. 3. What Uses of Drugs are Investigational? -- The Experiment-Therapy Continuum -- The Belmont Report -- Ethical Considerations -- FDA's Approach to the Definitional Task -- Ch. 4. The Interim Rule and Its Alternatives -- Issues Associated with the Interim Rule -- Alternatives to the Interim Rule -- Ch. 5. Broader Issues -- Internal DoD Issues -- The Question of Authority -- Interactions Between DoD and FDA -- Ch. 6. Conclusions and Recommendations -- Ch. 7. Postscript
Control code
ocm44963321
Dimensions
unknown
Extent
1 online resource (xx, 102 pages)
Form of item
online
Isbn
9780585245478
Note
eBooks on EBSCOhost
Specific material designation
remote
System control number
(OCoLC)44963321
Label
Military use of drugs not yet approved by the FDA for CW/BW defense : lessons from the Gulf War, Richard A. Rettig
Publication
Note
  • "Prepared for the Office of the Secretary of Defense, National Defense Research Institute."
  • "MR-1018-9-OSD"--Page 4 of cover
Bibliography note
Includes bibliographical references (pages 99-102)
Color
multicolored
Contents
Ch. 1. Introduction -- Purpose and Organization -- Background -- The Issues -- The Text of the Interim Rule -- Ch. 2. The History of the Interim Rule -- The Memorandum of Understanding Between DoD and FDA -- Careful Deliberations: 1990 -- Litigation: 1991 -- Actual Gulf War Experience with PB, BT and AX -- The Presidential Advisory Committee -- Ch. 3. What Uses of Drugs are Investigational? -- The Experiment-Therapy Continuum -- The Belmont Report -- Ethical Considerations -- FDA's Approach to the Definitional Task -- Ch. 4. The Interim Rule and Its Alternatives -- Issues Associated with the Interim Rule -- Alternatives to the Interim Rule -- Ch. 5. Broader Issues -- Internal DoD Issues -- The Question of Authority -- Interactions Between DoD and FDA -- Ch. 6. Conclusions and Recommendations -- Ch. 7. Postscript
Control code
ocm44963321
Dimensions
unknown
Extent
1 online resource (xx, 102 pages)
Form of item
online
Isbn
9780585245478
Note
eBooks on EBSCOhost
Specific material designation
remote
System control number
(OCoLC)44963321

Library Locations

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