Dear Dr. McClellan:

As you are aware, the Food and Drug Administration (FDA) recently approved pyridostigmine bromide (PB) as a pretreatment for the nerve agent soman. During the 1991 Gulf War, PB was classified as an investigational new drug for this purpose, a classification that remained in effect until FDA's decision earlier this month. Approximately 250,000 military personnel ingested PB during the Gulf War and some believe it may be one of the possible causes of ill-defined and unexplained multi-symptom illnesses, known collectively as Gulf War veterans' illnesses, plaguing thousands of Gulf War veterans.

With a possible second war with Iraq looming on the horizon, we understand the importance of protecting the men and women that will be going into harms way, but there are many unanswered questions concerning the safety and efficacy of PB for use as a nerve agent pretreatment. Both the RAND Corporation, in a 1999 report, and the National Academy of Sciences Institute of Medicine (IOM), in a 2000 report, were not able to rule out PB as a possible cause of Gulf War veterans' illnesses. Research conducted since these reports were released further suggests a possible association between PB and long-term health problems.

It is our understanding that PB is the first drug approved under FDA's new "animal efficacy rule" that allows the use of animal data as evidence of a drug's effectiveness for certain conditions when the drug cannot be ethically or feasibly tested in humans. We also understand that FDA did not conduct an advisory committee of independent researchers familiar with PB as is customary. In light of this, and the fact that PB has not been ruled out as a cause of Gulf War veterans' illnesses and research into possible long-term health effects is ongoing, we think it would be appropriate to conduct hearings to examine FDA's decision making process regarding PB and the science used to support its decision. Our main concern is to ensure that FDA's decision to approve PB was a fully informed one.

Your consideration of this very important matter is greatly appreciated.

Sincerely,

Steve Robinson

Executive Director NGWRC

cc: Members of Congress

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Last revised: March 2003