Examining Possible Causes of Gulf War Illness: RAND Policy Investigations and Reviews of the Scientific Literature
Nov 25, 2005
Note: Many electronic documents posted prior to 2003 are available as chapter PDFs or HTML files linked from the Contents.
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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.
Figure and Tables HTML
The History of the Interim Rule HTML
What Uses of Drugs Are Investigational? HTML
The Interim Rule and Its Alternatives HTML
Broader Issues HTML
Conclusions and Recommendations HTML