CDMRP-Funded Study Finds the First Treatment for Gulf War Illness Symptoms

A new Congressionally Directed Medical Research Program (CDMRP) study has found the first successful treatment for some aspects of Gulf War Illness (GWI), a neurological disease with immunological dysfunction resulting in an array of chronic, debilitating symptoms that affects more than one in three veterans of the 1991 Gulf War.

The finding comes on the heels of highly flawed Washington Post and Military Times (Army Times, Marine Corps Times, etc.) articles suggesting the tiny CDMRP is duplicative and is taking needed DoD funding from elsewhere.

For GWI, research funding is available through two sources, the U.S. Department of Veterans Affairs (VA) and the CDMRP.  VA funding is restricted to VA employees.  CDMRP funding is available to any qualified researchers, including in academia or the public or private sectors, through a highly competetive, peer-reviewed process that includes "consumer reviewers" at every stage of the review process. ("Consumer reviewers" are individuals who are personally affected by the disease or disorder being studied.)

The study, led by Dr. Beatrice Golomb of the University of California-San Diego, has found that use of Coenzyme Q10, a powerful anti-oxidant, alleviates some of the most commonly reported symptoms of Gulf War Illness, including headaches, inability to focus, and fatigue after exertion.

The study found that some participants also had reduced chronic diarrhea and improved blood pressure levels.

The treatment uses liquid gel caps of the ubiquinone form of CoQ10 (not "ubiquinol") at 100mg and 300mg daily doses.  Taking the CoQ10 too late in the day, especially at higher doses, may have negatively impacted sleep quality.

The study found that pain relief was greater at the higher dosage.   Dr. Golomb said her study used CoQ10 produced by Jarrow Formulas.

The treatment was targeted at, and appears to have positively impacted the mitochondrial dysfunction believed to be a resultant component of GWI. In 2010, the Institute of Medicine estimated that 250,000 of the 696,842 veterans of the 1991 Gulf War are affected by this chronic multi-symptom illness.

The CDMRP was first funded for GWI in FY2006, and Dr. Golomb's study was among that first group that was funded.  

Read today's Page 4 USA Today news story about the new CDMRP-funded study:

• Anti-oxidants ease Gulf War Syndrome, study finds - USATODAY.com

Gel cap CoQ10 is available at highly discounted prices online at www.swansonvitamins.com.   Dr. Golomb also recommends Carlson brand cod liver oil.


-Anthony Hardie, Madison, Wis.

Gulf War Health Research Meetings to be Held in Wash., DC June 27-28

(91outcomes.com) – The next meeting of the U.S. Department of Veterans Affairs Research Advisory Committee on Gulf War Veterans’ Illnesses (RAC-GWVI) will be held in Washington, DC on June 27-28, 2011 at the VA central office at 811 Vermont Ave., NW. 

Among the presenters are Dr. Nancy Klimas, one of the world’s leading researchers on Chronic Fatigue Syndrome (CFS/ME) and Dr. Lea Steele, past Scientific Director of the RAC-GWVI and the principal author of the groundbreaking 2008 RAC Report demonstrating that GWI is real.  Both Klimas and Steele are among the world’s leading researchers on GWI.

Also presenting is Dr. Beatrice Golomb, a renowned researcher and clinician and the first Scientific Director of the RAC-GWVI, who will be presenting the results of the first positive treatment trial for Gulf War Illness.  The study, funded by the acclaimed Congressionally Directed Medical Research Program (CDMRP), finds that Coenzyme Q10 is effective at the mitochondrial level in helping to relieve some GWI symptoms.

Other distinguished presenters include:  Dr. Polly Matzinger of the National Institutes of Health, NIAID; Dr. Gordon Broderick of the University of Alberta, who works closely with Dr. Klimas and Dr. Steele; and, Dr. Scott Panter of the San Francisco VA Medical Center.

VA officials from the Office of Research and Development will also be presenting, including Dr. Timothy O’Leary, Dr. William Goldberg, and
Dr. Joseph Salvatore. 

A committee discussion on the new comprehensive plan for GWI research, which has been developed following a conference with the VA Gulf War Steering Committee, will take up most of the second day of the RAC-GWVI’s meetings.

The tentative RAC-GWVI agenda is as follows.  All meetings are open to the public and public input is both welcome and encouraged during the scheduled public input sessions on both days of the meetings.

The final agenda will be posted at:  http://www.va.gov/RAC-GWVI/Meetings.asp 

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Monday, June 27, 2011

Sonny Montgomery Conference Room, 2nd Floor, U.S. Department of Veteran Affairs, 810 Vermont Avenue, Washington, DC

8:00 – 8:30 Informal gathering, coffee

8:30 – 8:35 Welcome, introductory remarks, Mr. Jim Binns, Chairman, RAC-GWVI

8:35 – 9:30 Altered immune functions in Gulf War illness and potential therapies, Dr. Nancy Klimas, Miami VA Medical Center

9:30 -10:30 From Cytokines to Cells to Gene Expression: An Integrative Approach to the Study of Gulf War illness, Dr. Gordon Broderick, University of Alberta

10:30 – 10:45 Break

10:45 – 11:45 The Danger Model of innate immune system activation, Dr. Polly Matzinger, National Institutes of Health, NIAID

11:45 – 12:30 Intranasal administration of toxicants and therapeutics, Dr. Scott Panter, San Francisco VA Medical Center

12:30 - 1:30 Lunch

1:30 – 2:15 Complex factors in the etiology of Gulf War Illness, Dr. Lea Steele, RAC-GWVI

2:15 – 3:00 Co-Enzyme Q10 treatment trial for Gulf War illness, Dr. Beatrice Golomb,  RAC-GWVI

3:00 – 3:45 Gulf War Pre-911 Report overview, Mr. Joseph Salvatore, VA Office of Policy and Planning

3:45 – 4:00 Break

4:00 - 4:30 Federal Advisory Committee Ethics Training, Mr. Jonathan Gurland, VA

4:30 – 5:00 Update of VA Gulf War research funding, Dr. William Goldberg, VA Office of Research and development

5:00 – 5:30 Public comment

Tuesday, June 28, 2011

***PLEASE NOTE DIFFERENT MEETING LOCATION***
Lafayette Building, 811 Vermont Ave., NW, Room 1143, Washington, DC

8:00 – 8:30 Informal gathering, coffee

8:30 - 9:30 Update of VA Gulf War Cooperative  Studies, Dr. Timothy O’Leary, VA Office of Research and development

9:30 – 10:15 Committee Discussion: VA Gulf War Comprehensive Research Strategy, led by Mr. Jim Binns, Chairman, Dr. Roberta White, Scientific Director, RAC-GWVI

10:15 – 10:30 Break

10:30 – 12:00 Committee Discussion (continued): VA Gulf War Comprehensive Research Strategy

12:00 – 12:30 Public comment

12:30 Adjourn

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--Anthony Hardie, Madison, Wis.

Latest News on LDN, a Possible Treatment for GWI, IBS, FM and more

The following were posted to the Low Dose Naltrexone website, at http://www.lowdosenaltrexone.org/ldn_latest_news.htm.

Special thanks to tireless GWI and MS advocate Nancy Rekowski for submitting this!

Successful Crohn’s Disease Trial Results Published. Jill P. Smith, MD, Professor of Gastroenterology at Pennsylvania State University's College of Medicine, and her colleagues, have published the results of their Phase II study of 40 adults with Crohn’s disease, “Therapy with the Opioid Antagonist Naltrexone Promotes Mucosal Healing in Active Crohn’s Disease: A Randomized Placebo-Controlled Trial”, in the online journal Digestive Diseases and Sciences, March 8, 2011.

The 4.5mg daily dose of naltrexone proved to have very positive results, with significant improvements in the Crohn’s Disease Activity Index scores and with substantial healing demonstrated by endoscopy. (See Clinical Trials for LDN / Recently Published.)

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Several Major Clinical Trials of LDN Await Publication. Three important clinical trials of LDN have each recently completed their planned studies and are now either undergoing final statistical analysis or are awaiting peer-review medical journal publication. Until that final step is achieved, we are proscribed from reporting any significant data results. However, we are pleased to observe that various useful outcomes will be reported by all three. The trials involved:

• LDN effects in HIV/AIDS in Mali, Africa
• LDN for fibromyalgia — a randomized, double-blind study at Stanford University
• LDN for Crohn’s disease — a Phase II, randomized placebo-controlled double-blinded study at Hershey Medical Center, Penn State College of Medicine

Promising Gulf War Illness Treatment Study Recruiting Participants in North Carolina

Respected GWI researcher to investigate two promising treatments for GWI with premier DoD-CDMRP funding

91outcomes Editor’s Note:

This Gulf War Illness treatment study is funded by the peer-reviewed, Congressionally Directed, U.S. Department of Defense Gulf War Illness Medical Research Program (CDMRP-GWI), the nation’s premier GWI research program.

Low Dose Naltrexone (LDN), one of the two drugs to be investigated for GWI in this study, has been found to have significant health benefits in patients with Multiple Sclerosis (MS) and several other chronic multi-symptom health conditions.  For more information on LDN, see:  www.lowdosenaltrexone.org.

The study’s Principal Investigator, Dr. William Meggs, is a respected scientist who has served on the Congressionally chartered U.S. Department of Veterans Affairs (VA) Research Advisory Committee on Gulf War Veterans’ Illnesses (RAC-GWVI) for many years. 

-Anthony Hardie

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GULF WAR ILLNESS STUDY

If you served in the 1991 Gulf War and developed symptoms of Gulf War related illness, you may be eligible to participate in a treatment protocol conducted by Dr. William J. Meggs at the Brody School of Medicine at East Carolina University, in Greenville, North Carolina and sponsored by the Department of Defense.

After a telephone screening interview, participants who qualify and wish to participate will be brought to the Brody School of Medicine at East Carolina University, in Greenville, North Carolina, to undergo an evaluation.

The study will test the benefits of two approved generic drugs, naltrexone and dextromethorphan, in treating the symptoms of Gulf War illnesses. These drugs will be studied because they are beneficial in illnesses similar to Gulf War illnesses, safe, readily available, and reduce inflammation in the brain that may be responsible for some of the symptoms that Gulf War Veterans are having.

If you feel that you may qualify for this study and are interested in participating, please contact Dr. William J. Meggs either by email [ meggsw@ecu.edu, copy to farmera@ecu.edu ], or telephone [252-744-2954].

President Expected to Sign New Gulf War Legislation, but What Does it Really Mean for Ill Gulf War Veterans?

UPDATED 2:02 P.M. CT, 09/30/2010

Written by Anthony Hardie

(91outcomes.com) – The annual veterans benefits bill passed by Congress this week and sent to the President for his expected signature contained measures of particular interest to Gulf War veterans.

In the Senate summary of the bill, it sounds promising on its face:

Section 805: National Academies review of best treatments for chronic multisymptom illness in Persian Gulf War veterans.

• Would direct the Secretary of Veterans Affairs to enter into an agreement with the National Academies Institute of Medicine to carry out a comprehensive review of best treatment practices for chronic multisymptom illness in Persian Gulf War veterans and develop a plan for dissemination of best practices throughout VA.
• Under such an agreement, would require the Institute of Medicine to convene a group of experts in chronic multisymptom illness in Gulf war veterans.
• Would require the Institute of Medicine to submit a report, including legislative and administrative recommendations, to the Secretary of Veterans Affairs and the Committees on Veterans’ Affairs of the Senate and House of Representatives no later than December 31, 2012.
• VA would be required to fund the Institute of Medicine review.
  

Section 806: Extension and modification of National  Academy of Sciences reviews and evaluations on illness and service in Persian Gulf War and Post 9/11 Global Operations Theaters.

• Would extend the review and evaluation of chronic multisymptom illness in Persian Gulf War veterans by the National Academy of Sciences to October 1, 2015.
• Would direct the National Academy of Sciences to disaggregate the data for theaters of operation before and after September 11, 2001, and to compile two separate reports, one pre- and one-post September 11.
• Would extend the sunset for this report provision to October 1, 2018.

It’s great that Congress has gotten the message that the primary focus for the IOM-estimated 250,000 veterans of the 1991 Gulf War still suffering from chronic multi-symptom illness related to hazardous agent exposures two decades ago is about finding effective treatments.

However, it is unclear how that the IOM will carry out its mission.  Typically, the IOM has reviewed existing research already concluded, published, and peer-reviewed.  Since there focus on treatments for GWI is relatively new, IOM won’t be finding much if that’s the method they will pursue.

What needs to be developed is a comprehensive research program to develop effective treatments.  And, like Gulf War veterans have been saying for years, those treatments need to be based on the outcomes of known Gulf War toxic exposures.

Congress should be applauded for including a measure that is clearly focused on treatments rather than “stress” or trying to determine if Gulf War veterans are really sick – we are.  Our disability payments probably cost the taxpayers far more than if the federal government had honed in on treatments in the first place rather than denial.

However, it remains to be seen if this new legislation will actually produce something meaningful to improve the health and lives of ill Gulf War veterans, or simply summarize what we already know:  effective treatments for the underlying GWI issues do not yet exist, so the distant second best effort remains to put pharmaceutical band-aids on the dozens of individual symptoms of a terrible and insidious ailment.

A detailed summary of the Veterans’ Benefits Act of 2010 is available here: LINK

The full text of the bill sent to the President, is available here: LINK

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Technorati Tags: Gulf War Syndrome,Gulf War Illness,Gulf War veterans,Persian Gulf War,1991 Gulf War,Gulf War,Anthony Hardie,91outcomes,91outcomes.com

"Mind-body" therapy shows promise for fibromyalgia, a Presumptive Condition for VA Service-Connection for Gulf War Veterans

By Reuters

NEW YORK - A form of 'mind-body' therapy may offer some relief to people with fibromyalgia, a small clinical trial suggests.

The study, of 45 women with fibromyalgia, found that those who learned a technique called "affective self-awareness" were more likely to show a significant reduction in their pain over six months.

Overall, 46 percent of the women had a 30-percent or greater reduction in their pain severity, as measured by a standard pain-rating scale. In contrast, of study participants who were assigned to a wait-list for therapy, none showed a similar decline in pain.

Fibromyalgia is a syndrome marked by widespread pain -- including at specific "tender points" in the body -- along with symptoms such as fatigue, irritable bowel and sleep problems. It is estimated to affect up to 5 million U.S. adults.

The precise cause of fibromyalgia is unknown -- there are no physical signs, such as inflammation and tissue damage in the painful area -- but some researchers believe the disorder involves problems in how the brain processes pain signals.

Standard treatments include painkillers, antidepressants, cognitive- behavioral therapy and exercise therapy. However, many people with fibromyalgia find that their symptoms -- pain, in particular -- persist despite treatment.

Part of that, according to the researchers on the new study, may be because standard treatments do not specifically address the role psychological stress and emotions can play in triggering people's pain.

That is not to say that the pain people with fibromyalgia feel is "all in their head," stressed Dr. Howard Schubiner, of St. John Health/ Providence Hospital and Medical Centers in Southfield, Michigan.

"The pain is very real," Schubiner said in an interview. But, he explained, pain and emotions are "connected in the brain," and emotional factors may act to trigger "learned nerve pathways" that give rise to pain.

Past studies have found that compared with people without fibromyalgia, those with the disorder have higher rates of stressful life events, such as childhood abuse, marital problems and high levels of job stress. There is also evidence that they are relatively less aware of their own emotions and more reluctant to express their feelings, particularly anger.

For the new study, published in the Journal of General Internal Medicine, Schubiner and his colleagues tested the effects of affective self-awareness -- a technique Schubiner developed and uses in treating certain chronic-pain conditions -- on fibromyalgia.

They randomly assigned 45 women with the condition to either undergo the therapy or go on a wait-list for treatment, serving as a control group. Women in the treatment group each had a one-on-one consultation, then attended three group meetings to learn the affective self-awareness techniques so that they could carry them out on their own.

The therapy involves an educational component where patients learn about the emotion-pain connection. They learn specific techniques -- including mindfulness meditation and "expressive" writing -- for recognizing and dealing with the emotions that may be contributing to their pain. Patients are also encouraged to get back to any exercise or other activities that they have been avoiding due to pain.

Schubiner's team found that six months later, 46 percent of the treatment group had at least a 30-percent reduction in their pain ratings compared with scores at the outset. And 21 percent had a 50-percent or greater reduction.

None of the women in the control group had a comparable improvement.

The study is only the first clinical trial to test affective self-awareness for fibromyalgia, and it had a number of limitations, including its small size. In addition, the control group received no active therapy to serve as a comparison.

That is important because it is possible for patients to benefit from simply receiving attention from a healthcare provider, or being part of small-group sessions with other people suffering from the same condition, for example.

Schubiner also acknowledged that this general "model" for understanding and addressing fibromyalgia pain is controversial.

He said that he and his colleagues have applied for funding to conduct a larger clinical trial comparing affective self-awareness with standard cognitive-behavioral therapy.

Affective self-awareness and cognitive-behavioral therapy have similarities, according to Schubiner. Both, for example, try to show patients that they have the power to improve their own health.

A key difference, Schubiner said, is that affective self-awareness asks people to "directly engage" the emotions that may be helping to drive their symptoms.

Another difference is that, right now, only a small number of healthcare providers practice affective self-awareness, according to Schubiner.

Some components of the technique, such as teachings in mindfulness meditation, are more widely available. But whether those practices in isolation would help fibromyalgia patients' pain is not clear.

SOURCE: Journal of General Internal Medicine, online June 8, 2010.

Fibromyalgia Treatment Trial of Droxidopa/Carbidopa Shows Favorable Progress

 Independent Data Monitoring Committee Sees Meaningful Efficacy in Multiple Treatment Arms -- Trial Focusing on Novel Droxidopa/Carbidopa Combination Therapy -- No Significant Adverse Events or Safety Concerns Observed in Any Treatment Arm

Fibromyalgia, a chronic multi-symptom disease with chronic widespread pain, is a presumptive condition for VA service-connection for Gulf War veterans

(GLOBE NEWSWIRE) - Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced the completion and favorable outcome of an independent Data Monitoring Committee (DMC) review of the safety and efficacy data from approximately half the target enrollment in Chelsea's Phase II trial of droxidopa in fibromyalgia.

The purpose of this scheduled DMC meeting was to review the efficacy of each dose group and determine if the efficacy data supported dropping underperforming arms in order to increase the power in those arms most likely to demonstrate a clinically relevant therapeutic benefit. Following their assessment of each of the 12 arms using the study's primary endpoint, a reduction in pain as measured by the Short Form McGill Pain Questionnaire, the DMC recommended that 7 of the 12 arms of the trial be continued to completion. This recommendation was based solely on their efficacy analysis, as there were no observed safety concerns associated with any arm of the study. As a result of this recommendation, the study will now focus primarily on multiple doses of droxidopa in combination with 50mg carbidopa.

"The DMC's recommendation aligns with our assumption going into the trial that by pairing droxidopa with carbidopa to limit peripheral metabolism of droxidopa, we should be able to drive efficacy of droxidopa in the treatment of fibromyalgia," commented Dr. Simon Pedder, president and CEO of Chelsea Therapeutics. "Following the interim analysis conducted by the DMC and subsequent recommendations, we can now, as hoped, allocate our full study resources to those treatment groups most likely to demonstrate therapeutic benefit and their associated control and placebo arms."

The Phase II trial, is a multi-centre, randomized, double-blind, placebo-controlled, dose response, factorial study that initially included 12 parallel groups evaluating droxidopa monotherapy, carbidopa monotherapy, droxidopa/carbidopa combination therapy or placebo. Accordingly, patients were randomized into each of 12 groups to receive: 200mg, 400mg or 600 mg of droxidopa TID; 25mg or 50mg carbidopa TID; 200/25mg, 400/25mg or 600/25mg droxidopa/carbidopa TID; 200/50mg, 400/50mg or 600/50mg droxidopa/carbidopa TID; or placebo over a 9-week treatment period.

Based on the DMC recommendation, the trial will be optimized to continue enrollment in the following seven arms: placebo; 50mg carbidopa TID, 600mg droxidopa TID; 400/25mg, 200/50mg, 400/50mg or 600/50mg droxidopa/carbidopa TID. The primary endpoint is the average reduction in pain as measured by the Short Form McGill Pain Questionnaire. Secondary outcomes of the study include Fibromyalgia Index Questionnaire (FIQ), Patient Global Impression of Change (PGI-C), Multidimensional Fatigue Inventory (MFI), and Hamilton Anxiety Depression survey (HAM-A).

Chelsea currently estimates top-line data from the study to be reported by year-end 2011.

About Droxidopa and Fibromyalgia

Fibromyalgia is a chronic and debilitating condition that is characterized by widespread pain and stiffness throughout the body, accompanied by severe fatigue, insomnia and mood symptoms. While the precise etiology of fibromyalgia remains unknown, current research has focused on the role of norepinephrine (NE) reuptake and availability in the central nervous system. NE, a widely used neurotransmitter in the central and peripheral nervous systems has long been linked to both chronic pain and depression. Droxidopa, a synthetic amino acid, is converted by the body into norepinephrine and, as a prodrug of NE, provides replacement therapy for NE deficiency. While NE, as a catecholamine does not penetrate the blood-brain barrier, droxidopa, as a neutral amino acid, is able to do so thus providing both a peripheral and central affect on circulating NE levels.

About Chelsea Therapeutics

Chelsea Therapeutics is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases. Chelsea's most advanced drug candidate, Northera(TM) (droxidopa), is an orally active synthetic precursor of norepinephrine initially being developed for the treatment of neurogenic orthostatic hypotension. In addition to Northera, Chelsea is also developing a portfolio of metabolically inert oral antifolate molecules engineered to have potent anti-inflammatory and anti-tumor activity to treat a range of immunological disorders, including two clinical stage product candidates: CH-1504 and CH-4051. Preclinical and clinical data suggest superior safety and tolerability, as well as increased potency versus methotrexate (MTX).

This press release contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include risks and costs of drug development, risk of regulatory approvals, our reliance on our lead drug candidates droxidopa and CH-4051, reliance on collaborations and licenses, intellectual property risks, our need to raise additional operating capital in the future, our history of losses, competition, market acceptance for our products if any are approved for marketing, and reliance on key personnel including specifically Dr. Pedder.

Read more: http://www.drugs.com/clinical_trials/chelsea-therapeutics-reports-positive-interim-analysis-phase-ii-trial-droxidopa-fibromyalgia-9743.html#ixzz0syh607M9

ARMY NEWS SERVICE ARTICLE: Researchers narrow Gulf War Syndrome causes

May 26, 2009

By Kyle Hodges

WASHINGTON (Army News Service, May 27, 2009) -- Research completed and analyzed over the past year has narrowed the underlying causes of Gulf War Syndrome to three factors.

For 18 years, researchers struggled to pinpoint the causes of Gulf War Syndrome and its wide-ranging symptoms. Then last year, a group of researchers under the U.S. Army Medical Research and Materiel Command and the Congressionally Directed Medical Research Program narrowed the primary causes to three: chemical nerve agents, pesticides, and the use of Pyridostigmine Bromide pills.

A report titled Gulf War Illness and the Health of Gulf War Veterans was released by the Department of Veteran's Affairs in November 2008, consolidating all research on the syndrome to date.

"There is definitely something different that has happened to servicemembers during the Gulf War as opposed to what is happening to Soldiers now," said retired Col. Melissa Forsythe, program manager of the Congressionally Directed Medical Research Program.

"Today's Soldiers don't exhibit any of the same symptoms," Forsythe said. "We're talking about the same geographical region. So what happened to these servicemembers in 1990-91 that's not happening now? That's really the central question."

Chemical nerve agents, PB, and many of the pesticides to which Gulf War veterans were exposed belong to a class of chemicals called Acetylcholinesterase inhibitors.

These chemicals inactivate the enzyme Acetylcholinesterase, which is essential for breaking down the neurotransmitter chemical acetylcholine - a chemical which affects numerous bodily functions, according to the report.

Forsythe believes a mixture of the three items above in combination with vaccines given to Gulf War servicemembers can't be ruled out as a possible cause for Gulf War Syndrome.

The acute symptoms of excess exposure to Acetylcholinesterase inhibitors results in increased salivation and respiratory secretions, nausea, abdominal cramping, diarrhea, excess sweating, increased heart rate, and blood pressure.

Other side effects can include muscle twitching, cramps, weakness, tremors, paralysis, fatigue, mental confusion, headache, poor concentration, and general weakness. At sufficient doses, exposure to Acetylcholinesterase inhibiting chemicals can result in respiratory arrest and death.

Many of these side effects coincide with those of GWS.

Typically, Gulf War veterans exhibit a number of symptoms including chronic headaches, widespread diffused pain that moves to different parts of the body, fatigue, gastrointestinal problems, cognitive difficulties, skin rashes, and respiratory problems, said Forsythe.

Because of the wide range of symptoms, a diagnosis of GWS could be likened to finding a needle in a haystack, Forsythe said. There is no one test that will yield a definitive diagnosis for this illness that affects 25-32 percent of Gulf War veterans, she said, adding that the only way to diagnose the disease is to eliminate all other diseases with similar symptoms.

Today's GWS research focuses primarily on diagnosis and treatment rather than a single cure.

Studies focusing on the physical differences between ill and healthy Gulf War veterans may make a diagnosis easier and provide a much needed legitimacy to the illness.

"At first, servicemembers were told that the illness was all in their heads. So now, it's very validating for those servicemembers to see that there are real physical differences between themselves and the Gulf War Veterans that are not ill," said Forsythe.

Other GWS studies by the CDMRP include: research looking into the over-the-counter herbal supplement Co-enzyme Q10; the drug methylpristine, which may help with cognitive problems; and plans to look at self medications that Gulf War veterans have used and whether or not those were effective. Acupuncture is also being looked at for possible funding.

Currently, the only relief for GWS sufferers is to prescribe treatments for their individual symptoms, said Forsythe.

Unfortunately, record keeping practices during the Gulf War were not equal to today's standards, said Forsythe. Records on the use of Pyridostigmine Bromide and pesticides in theatre are virtually nonexistent.

PB had been approved, since 1955, for treatment of myasthenia gravis, a muscular disease. During the Gulf War, PB was not licensed for protection against chemical nerve agents by the U.S. Food and Drug Administration, but it was authorized by the FDA to be released to Soldiers in combat as an "investigational new drug" as a nerve agent pretreatment.

PB is now FDA approved as an effective pretreatment exclusively for the nerve agent soman and it is still issued to Soldiers for that purpose.

Pesticides are still used in theater, however, only a handful of those pesticides linked to GWS in the report are still in the Department of Defense's pest control inventory.

"Research is not necessarily fast, but is our best route in terms of helping people," said Forsythe. We know that people are out there suffering and they're trying to find their own remedies for symptoms. So our program, being focused on improving the diagnosis and treatments, is trying to get at the two prongs that can best serve those veterans who are ill."