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

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 Departme...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Rettig, Richard A.
Autores Corporativos: United States. Department of Defense. Office of the Secretary of Defense, National Defense Research Institute (U.S.)
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Santa Monica, Calif. : RAND, 1999.
Colección:Gulf War illnesses series.
Temas:
United States > Food and Drug Administration
1991
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.
Vaccines
Guerre chimique > Sécurité > Mesures.
Guerre biologique > Sécurité > Mesures.
Gaz asphyxiants et délétères > Antagonistes.
Vaccins.
Consentement éclairé (Droit médical) > États-Unis.
Traitement non volontaire (Thérapeutique) > États-Unis.
Guerre du golfe Persique, 1991 > Guerre chimique.
HISTORY > Military > Biological & Chemical Warfare.
Medicine, Military
Armed Forces > Medical care
Biological warfare > Security measures
Chemical warfare
Chemical warfare > Security measures
Informed consent (Medical law)
Involuntary treatment
United States > Armed Forces > Medical care.
Middle East
United States
Acceso en línea:Texto completo
Tabla de Contenidos:
  • 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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