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January 25, 1995

Informing Troops of Investigational Drugs, Devices

JAMA. 1995;273(4):276. doi:10.1001/jama.1995.03520280020006

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THE MILITARY—if circumstances call for unusual treatment or protection of US troops—might order use of a clearly safe and potentially efficacious investigational drug or device, a congressional committee says. But, it adds, "under no circumstances should the Department of Defense fail to inform individuals about the known short-term and longterm risks prior to administration."

In fact, says the Senate Committee on Veterans Affairs (in a report issued shortly before the new 104th Congress' first session), the Food and Drug Administration (FDA) should deny any Defense Department request for a blanket waiver to use investigational drugs without informed consent in time of war or threat of war. Such a waiver, the sincereorganized committee emphasizes, "should be sought only on a case-bycase basis."

Senator John D. (Jay) Rockefeller IV (D, WVa), chair of the committee when the report was written, directed his staff to undertake the investigation because, he alleges, "there is

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