Mr. Chairman I appreciate the opportunity to appear before the Subcommittee on Health and Subcommittee on Oversight and Investigations to report on our efforts to bring forward work of significance for Gulf War veterans.

The Department of Defense and RAND Corporation recently released the latest in a series of scientific literature reviews on potential health issues affecting Gulf War veterans.

This work presents a great deal of information that wasn't available to decision-makers during the Gulf War. It is a thorough review of an important issue in the search for answers to Gulf War illnesses. We believe this information is valuable both to Gulf War veterans and in the continued research on pyridostigmine bromide (PB).

The RAND paper examines the safety and effectiveness of pyridostigmine bromide (PB), as used during the Gulf War as a pretreatment to protect military personnel from the nerve agent soman. The work was performed to identify hypotheses or theories that might link PB to illnesses in Gulf War veterans.

Two major conclusions emerge from this review of the scientific literature, one pertaining to safety and one to the effectiveness of PB as used as a pretreatment against soman. The report concludes that while medical research has not established PB as a cause of Gulf War illnesses, it cannot be ruled out as a possible contributor to the development of illnesses in some Gulf War veterans.

The paper also concludes that further research is needed to determine the effectiveness of the current dose of PB against soman. At this time, a very active research program is continuing on all the hypotheses identified by RAND. The Department has asked the Armed Forces Epidemiology Board, an outside panel of distinguished medical experts, to evaluate the RAND review and advise DoD on whether present research directions should be altered.

This review will also be evaluated by the Institute of Medicine as part of its review and assessment of published scientific literature related to exposure of Gulf War veterans and any associations with health effects. We have already forwarded copies of this report to the IOM and clearly understand they are going to expedite their review of this work.

The Department has participated in a comprehensive and collaborative research effort to more fully understand the nature of the illnesses. From FY94 through FY99 more than $134 million has been invested for research on illnesses among Gulf War veterans. To date, over 26 peer-reviewed studies with funding in excess of $20 million, address the health consequences of PB use for nerve agent pretreatment. The Persian Gulf Veterans Coordinating Board has given priority to studies on PB, either alone or in combination with other exposures.

Pyridostigmine bromide is an FDA-approved drug for the civilian use of treating myasthenia gravis, a neuro-muscular disorder. However, PB is considered to be an investigational drug when used as a pre-treatment against chemical warfare agents because FDA has not licensed PB for that use. FDA rules, with a few narrow exceptions, require that investigational drugs be administered with the informed consent of the person being treated. For the Gulf War, FDA waived the informed consent requirement for the administration of PB because if concurred with DoD's assessment that informed consent was not feasible and that withholding treatment would be contrary to the best interests of military personnel.

We've learned a lot from our experience with PB in the Gulf War. In 1998, the Strom Thurmond National Defense Authorization Act for Fiscal Year 1999 established specific criteria for granting a waiver of informed consent for the use of investigational drugs in a particular military operation. Specifically, only the Secretary of Defense can request a waiver and only the President can grant a waiver of informed consent under certain circumstances. On September 30, 1999, the President issued executive order 13139 which clearly states the procedures he will use in considering a waiver request from the Secretary of Defense. It also sets requirements for DoD to follow in documenting the investigational drug's use, communicating health risk information to the troops and monitoring the health effects of the investigational drug.

In considering the future use of PB we must always balance the risks of war, to include the potential for use of deadly nerve agents such as soman with the possible side effects from the drugs. Currently, PB is thought to be an essential part of the medical protection our troops will have available if the extremely lethal soman nerve agent is found to be a credible threat.

The primary author of the paper, Dr. Beatrice Golomb, joins us here today to discuss the findings with committee members. With that, I'm pleased to answer any questions you may have.

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