Military use of drugs not yet approved by the FDA for CW/BW defense: lessons from the Gulf War
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Format: | Elektronisch E-Book |
| Sprache: | English |
| Veröffentlicht: |
Santa Monica, Calif.
RAND
1999
|
| Schriftenreihe: | Gulf War illnesses series
|
| Schlagworte: | |
| Online-Zugang: | FAW01 FAW02 Volltext |
| Beschreibung: | "Prepared for the Office of the Secretary of Defense, National Defense Research Institute.". - "MR-1018-9-OSD"--Cover page 4 Includes bibliographical references (pages 99-102) 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 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 |
| Beschreibung: | 1 Online-Ressource (xx, 102 pages) |
| ISBN: | 0585245479 0833026836 9780585245478 9780833026835 |
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| 245 | 1 | 0 | |a Military use of drugs not yet approved by the FDA for CW/BW defense |b lessons from the Gulf War |c Richard A. Rettig |
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| 500 | |a Includes bibliographical references (pages 99-102) | ||
| 500 | |a 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 | ||
| 500 | |a 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 | ||
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| 650 | 7 | |a HISTORY / Military / Biological & Chemical Warfare |2 bisacsh | |
| 650 | 4 | |a Chemical warfare |x Security measures | |
| 650 | 4 | |a Biological warfare |x Security measures | |
| 650 | 4 | |a Gases, Asphyxiating and poisonous |x Antagonists | |
| 650 | 4 | |a Vaccines | |
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Datensatz im Suchindex
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| author | Rettig, Richard A. |
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| dewey-ones | 358 - Air & other specialized forces |
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| discipline | Militärwissenschaft |
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| geographic | Naher Osten USA |
| geographic_facet | Naher Osten USA |
| id | DE-604.BV043071983 |
| illustrated | Not Illustrated |
| indexdate | 2024-07-10T07:16:34Z |
| institution | BVB |
| isbn | 0585245479 0833026836 9780585245478 9780833026835 |
| language | English |
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| spelling | Rettig, Richard A. Verfasser aut Military use of drugs not yet approved by the FDA for CW/BW defense lessons from the Gulf War Richard A. Rettig Santa Monica, Calif. RAND 1999 1 Online-Ressource (xx, 102 pages) txt rdacontent c rdamedia cr rdacarrier Gulf War illnesses series "Prepared for the Office of the Secretary of Defense, National Defense Research Institute.". - "MR-1018-9-OSD"--Cover page 4 Includes bibliographical references (pages 99-102) 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 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 United States / Food and Drug Administration Legislation, Drug / Middle East Legislation, Drug / United States Biological Warfare / prevention & control / Middle East Biological Warfare / prevention & control / United States Chemical Warfare / prevention & control / Middle East Chemical Warfare / prevention & control / United States Drugs, Investigational / Middle East Drugs, Investigational / United States Military Medicine / Middle East Military Medicine / United States HISTORY / Military / Biological & Chemical Warfare bisacsh Chemical warfare Security measures Biological warfare Security measures Gases, Asphyxiating and poisonous Antagonists Vaccines Informed consent (Medical law) United States Involuntary treatment United States Persian Gulf War, 1991 Chemical warfare Naher Osten USA United States Department of Defense Sonstige oth National Defense Research Institute (U.S.) Sonstige oth http://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=20478 Aggregator Volltext |
| spellingShingle | Rettig, Richard A. Military use of drugs not yet approved by the FDA for CW/BW defense lessons from the Gulf War United States / Food and Drug Administration Legislation, Drug / Middle East Legislation, Drug / United States Biological Warfare / prevention & control / Middle East Biological Warfare / prevention & control / United States Chemical Warfare / prevention & control / Middle East Chemical Warfare / prevention & control / United States Drugs, Investigational / Middle East Drugs, Investigational / United States Military Medicine / Middle East Military Medicine / United States HISTORY / Military / Biological & Chemical Warfare bisacsh Chemical warfare Security measures Biological warfare Security measures Gases, Asphyxiating and poisonous Antagonists Vaccines Informed consent (Medical law) United States Involuntary treatment United States Persian Gulf War, 1991 Chemical warfare |
| title | Military use of drugs not yet approved by the FDA for CW/BW defense lessons from the Gulf War |
| title_auth | Military use of drugs not yet approved by the FDA for CW/BW defense lessons from the Gulf War |
| title_exact_search | Military use of drugs not yet approved by the FDA for CW/BW defense lessons from the Gulf War |
| title_full | Military use of drugs not yet approved by the FDA for CW/BW defense lessons from the Gulf War Richard A. Rettig |
| title_fullStr | Military use of drugs not yet approved by the FDA for CW/BW defense lessons from the Gulf War Richard A. Rettig |
| title_full_unstemmed | Military use of drugs not yet approved by the FDA for CW/BW defense lessons from the Gulf War Richard A. Rettig |
| title_short | Military use of drugs not yet approved by the FDA for CW/BW defense |
| title_sort | military use of drugs not yet approved by the fda for cw bw defense lessons from the gulf war |
| title_sub | lessons from the Gulf War |
| topic | United States / Food and Drug Administration Legislation, Drug / Middle East Legislation, Drug / United States Biological Warfare / prevention & control / Middle East Biological Warfare / prevention & control / United States Chemical Warfare / prevention & control / Middle East Chemical Warfare / prevention & control / United States Drugs, Investigational / Middle East Drugs, Investigational / United States Military Medicine / Middle East Military Medicine / United States HISTORY / Military / Biological & Chemical Warfare bisacsh Chemical warfare Security measures Biological warfare Security measures Gases, Asphyxiating and poisonous Antagonists Vaccines Informed consent (Medical law) United States Involuntary treatment United States Persian Gulf War, 1991 Chemical warfare |
| topic_facet | United States / Food and Drug Administration Legislation, Drug / Middle East Legislation, Drug / United States Biological Warfare / prevention & control / Middle East Biological Warfare / prevention & control / United States Chemical Warfare / prevention & control / Middle East Chemical Warfare / prevention & control / United States Drugs, Investigational / Middle East Drugs, Investigational / United States Military Medicine / Middle East Military Medicine / United States HISTORY / Military / Biological & Chemical Warfare Chemical warfare Security measures Biological warfare Security measures Gases, Asphyxiating and poisonous Antagonists Vaccines Informed consent (Medical law) United States Involuntary treatment United States Persian Gulf War, 1991 Chemical warfare Naher Osten USA |
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