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PUBLIC RELEASE DATE:
1-Sep-2009

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Contact: Dayna Hochstein
dhochstein@spectrumscience.com
202-587-2524
US Department of Defense Congressionally Directed Medical Research Programs

Researchers to discuss new study on Gulf War illness treatment at Military Health Research Forum

Clinical trial of the drug mifepristone aims to evaluate treatment of Gulf War illness symptoms

KANSAS CITY, MO -- September 1, 2009 -- New research on treating Gulf War Illness (GWI) is being presented this week at the Military Health Research Forum (MHRF), a scientific meeting hosted by the Department of Defense (DoD) Congressionally Directed Medical Research Programs (CDMRP). GWI is a condition that affects approximately 25 percent of service men and women who served in the 1990-1991 Gulf War. It is characterized by symptoms including fatigue, headache, joint pain, sleep disturbances, and memory problems, and is potentially a result of the veterans' exposure to toxic elements during their time on duty.

The study was funded by the Gulf War Illnesses Research Program (GWIRP) and managed by the CDMRP. The GWIRP strives to improve the health and lives of veterans who have GWI by supporting innovative research to improve its diagnosis, to better understand its pathobiology and to identify effective treatments for its array of symptoms.

"This program represents much needed movement to address the health concerns of those individuals who served the United States during the Gulf War," said Captain E. Melissa Kaime, M.D., director of the CDMRP. "In order to further assist our veterans, more extensive research of GWI and effective treatments for its various conditions is much needed."

A Randomized, Double-Blind, Placebo-Controlled, Crossover Trial of Mifepristone in Gulf War Veterans with Chronic Multisymptom Illness (CMI)
Principal Investigator: Julia Golier, M.D., Bronx Veterans Medical Research Foundation, Inc.

A large percentage of Gulf War veterans - estimates range from 34 to 65 percent - continue to suffer from chronic multisymptom illness, also known as GWI. Symptoms can include fatigue, joint pain, headache, rash and cognitive problems, which may reflect altered regulation of the hypothalamic-pituitary-adrenal (HPA) axis. The HPA axis is responsible for regulating many things in the body, from the immune system and energy usage, to controlling reactions to stress and trauma. Abnormal functioning of the HPA leads to negative effects on many systems in the body, including the immune system and the nervous system.

Studies have shown that veterans of the 1991 Gulf War have an enhanced neuroendocrine response to a specific type of hormone called glucocorticoids. The increased physical response is associated with chronic fatigue syndrome, fibromyalgia and post-traumatic stress disorder, all of which can occur with chronic multisymptom illness. This study aims to determine if mifepristone, a glucocorticoid receptor antagonist, could decrease the enhanced response and therefore improve the physical and mental health and cognitive functioning of Gulf War veterans.

Researchers from the Mount Sinai School of Medicine in New York and the James J. Peters VA Medical Center in the Bronx are evaluating veterans of the 1991 Gulf War with chronic multisymptom illness but without any exclusionary psychiatric or medical conditions. All subjects will be treated for a six-week time period with the mifepristone compound and then, a month later, treated with an alternative compound (placebo) in a crossover design. Researchers will then evaluate physical health, cognitive functioning and mental health in subjects and determine if there is improvement in these areas in relation to mifepristone administration.

"A positive outcome would provide a new therapeutic avenue for treating ill Gulf War veterans, for whom there are currently few treatment options," says Julia Golier, M.D., a psychiatrist at Mount Sinai. "The trial will also provide an important proof of concept of whether this type of drug will improve physical health and cognitive outcomes in symptomatic Gulf War veterans, thus improving their overall health."

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About the Military Health Research Forum

The Military Health Research Forum (MHRF) is a scientific conference for presenting research studies funded by the DoD CDMRP Peer-Reviewed Medical, Gulf War Illness, and Psychological Health and Traumatic Brain Injury Research Programs. Research supported by these programs addresses the healthcare needs of the Armed Forces and their families, veterans and the American public.

The MHRF brings together scientists, clinicians, consumer advocates, policymakers and the military to learn about research and product development advancements supported by the host programs. The conference includes invited presentations by noted scientists, educational sessions on topics of general interest and poster and symposium presentations by CDMRP-funded investigators across programs. The MHRF is designed to promote the exchange of ideas to facilitate research progress, the development of new partnerships and the translation of research findings into field-ready methods and products.

About the Congressionally Directed Medical Research Programs

In the early 1990s, the breast cancer advocacy community launched a grassroots effort to raise public awareness of the crucial need for increased funding of breast cancer research. Beginning in fiscal year 1992 (FY92), Congress appropriated $25 million for breast cancer research to be managed by the Department of Defense. The following year, Congress continued to respond to the advocacy movement and appropriated $210 million for breast cancer research, marking the beginning of the U.S. Army Medical Research and Materiel Command's Congressionally Directed Medical Research Programs. The CDMRP represents a unique partnership among the public, Congress and the military. Because of continued and expanded advocacy efforts, the CDMRP has grown to encompass multiple targeted programs and has received more than $5.3 billion in appropriations from its inception in FY93 through FY09.



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