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RECORD VERSION

Submitted To

November 16, 1999

Introduction

Chairman and Distinguished Committee Members, I am Dr. Sue Bailey, Assistant Secretary of Defense for Health Affairs. I am honored to appear before your Committee today to address your questions about the Department of Defense (DOD) use of the drug pyridostigmine bromide as it relates to Gulf War veterans.

Soman is an extremely lethal nerve agent, suspected to be in the arsenal of potential adversaries. There is no effective treatment approved by the Food and Drug Administration (FDA) for exposure to these agents. However, the results of animal tests suggest that use of pyridostigmine bromide (PB) as a pretreatment adjunct, coupled with standard post-exposure treatments, may be effective. PB is approved by the FDA as safe and effective treatment of certain neuromuscular disorders, but it has not been approved for marketing as a nerve agent antidote, and is therefore classified as an "investigational new drug" for this medical purpose.

As noted in the Federal Register notices concerning 21 CFR Part 50, "During the months preceding the Persian Gulf War, DoD had discussions with the FDA regarding the potential use of specific investigational products in military personnel serving in the Gulf. It was thought that the products discussed represented the best preventive or therapeutic treatment for diseases endemic to the area and in providing protection against possible chemical or biological weapons. DoD requested the assistance of FDA in allowing the use of these products in certain battlefield or combat-related situations in which they considered obtaining informed consent "not feasible."

On December 28, 1990, DoD submitted protocols under IND’s and requests for waiver of informed consent for pyridostigmine bromide 30-milligram (mg) tablets to the Food and Drug Administration. Pyridostigmine bromide was considered a potentially useful pretreatment against certain nerve gases. The Commissioner approved the Department’s waiver requests for pyridostigmine bromide 30-mg tablets on December 31, 1990. This product was administered to portions of the military personnel who participated in Operation Desert Storm War.

Concerns have been expressed as to whether PB may have contributed to Gulf War veterans’ illnesses. Reviews conducted by the Institute of Medicine and the Presidential Advisory committee on Gulf War Veterans’ Illnesses did not consider PB a likely cause. The recent RAND study concludes that medical research to date has not ruled out some hypotheses of PB as a possible contributor. The RAND study requires further independent review. I have asked the Armed Forces Epedimiology Board to review the research merit of the recommendations posited in the study.

Much of the research now being accomplished on PB is being done under the direction of the Persian Gulf Veterans Coordinating Board. This Board is composed of representatives from the Departments of Health and Human Services, Veterans Affairs and Defense. Right now, there are 26 scientific, peer-reviewed research projects underway specifically addressing the health consequences of PB as a nerve agent pretreatment. The funding for this research is approaching $20 million.

These studies include evaluations of the interactions of PB with other chemicals such as insecticides or with physiological variables such as heat and stress. Several studies examine the interactions between PB and low level exposure to nerve agents. Other research addresses susceptibility of certain individuals to PB because of their genetic make-up. These on-going studies, to date, reveal no definitive results to link PB to the illnesses of our Gulf Veterans. But, we must continue with this very important research.

On September 30, 1999,President Clinton signed Executive Order 13139, entitled "Improving Health Protection of Military Personnel Participating in Particular Military Operations." This Executive Order addresses the President’s role under 10 U.S.C. 1107, a law that authorizes a Presidential waiver of informed consent for the use of investigational new drugs for force health protection in certain military operations. Supporting the E.O. is a new regulation issued by the FDA on October 5, 1999, the interim final rule. Also based on 10 U.S.C. 1107, this rule establishes the standards and criteria both the President and the Secretary of Defense will use to consider the potential need to use an investigational new drug for force protection in a particular military operation without the informed consent of the affected military personnel. These standards and criteria are very detailed and exacting. The next important action in establishing policy for the use of investigational new drugs for force health protection will be the issuance by the Secretary of Defense of a DoD Directive incorporating the requirements of 10 U.S.C. 1107, the Executive Order, and the FDA interim final rule. Following involvement of multiple DoD components, I expect this to be issued early next year.

My responsibility as the Assistant Secretary of Defense for Health Affairs is to advise the Secretary on all matters pertaining to the health of our forces. As all of you know, the world has changed. As we consider the threats our forces face, we now must consider the horrendous complications wrought by chemical and biological warfare agents. We know that the nerve agent soman is among the chemical agents in the arsenals of countries opposed to the United States. Soman is a rapidly lethal nerve agent. Standard treatments for other nerve agents are not effective against soman. PB as a pretreatment coupled with standard post-exposure treatments may well protect our forces. If faced with a decision today to recommend or not recommend the use of PB for the protection of our troops, when under a confirmed high threat of the use of soman, I would recommend PB be used. To counter soman, PB, in conjunction with protective gear and post exposure treatment, is the best measure we have to help protect the lives of America’s sons and daughters. PB is an essential element in the military medical defense against use of soman by enemy forces. Because PB is not FDA-approved for this indication, the Department will follow the guidelines for IND usage of PB as established in the statutes, the Executive Order, and the FDA’s interim final rule on standards and criteria.

Thank you for the opportunity to discuss this issue with you. I would be pleased to answer any questions you may have.

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