| Description |
1 online resource (xx, 102 pages). |
| Physical Medium |
polychrome |
| Description |
text file |
| Series |
Gulf War illnesses series
|
|
Gulf War illnesses series.
|
| Note |
"Prepared for the Office of the Secretary of Defense, National Defense Research Institute." |
|
"MR-1018-9-OSD"--Page 4 of cover. |
| Bibliography |
Includes bibliographical references (pages 99-102). |
| 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. |
| 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. |
| Local Note |
eBooks on EBSCOhost EBSCO eBook Subscription Academic Collection - North America |
| Subject |
United States. Food and Drug Administration. |
|
United States. Food and Drug Administration. |
|
Chemical warfare -- Security measures.
|
|
Chemical warfare -- Security measures. |
|
Chemical warfare. |
|
Biological warfare -- Security measures.
|
|
Biological warfare -- Security measures. |
|
Biological warfare. |
|
Gases, Asphyxiating and poisonous -- Antagonists.
|
|
Gases, Asphyxiating and poisonous. |
|
Enemies. |
|
Vaccines.
|
|
Vaccines. |
|
Informed consent (Medical law) -- United States.
|
|
Informed consent (Medical law) |
|
United States. |
|
Involuntary treatment -- United States.
|
|
Involuntary treatment. |
|
United States -- Armed Forces -- Medical care.
|
|
Armed Forces. |
|
Medical care. |
|
Persian Gulf War, 1991 -- Chemical warfare.
|
|
Persian Gulf War (1991) |
|
Legislation, Drug. |
|
Biological Warfare -- prevention & control. |
|
Chemical Warfare -- prevention & control. |
|
Drugs, Investigational. |
|
Military Medicine. |
|
Middle East. |
|
United States. |
| Genre/Form |
Electronic books.
|
| Added Author |
United States. Department of Defense. Office of the Secretary of Defense.
|
|
National Defense Research Institute (U.S.)
|
| Other Form: |
Print version: Rettig, Richard A. Military use of drugs not yet approved by the FDA for CW/BW defense. Santa Monica, Calif. : RAND, 1999 0833026836 (DLC) 00502281 (OCoLC)41536148 |
| ISBN |
0585245479 (electronic book) |
|
9780585245478 (electronic book) |
|
9780833026835 (v. 9) |
|
0833026836 (v. 9) |
|
0833026836 (paperback) |
| Report No. |
RAND/MR-1018/9-OSD |
|
