Research Advisory Committee on Gulf War Veterans' Illnesses Finds Path Towards Possible Treatments for Gulf War Illness

Written by Anthony Hardie, 91outcomes

(91outcomes.blogspot.com) - Today, the federal government for the first time ever held a day-long session hearing scientific and medical presentation on treatments for Gulf War Illness, with extraordinary results.

The federal, Congressionally chartered Research Advisory Committee on Gulf War Veterans' Illnesses is meeting at the Boston University School of Public Health today and tomorrow to review scientific and medical information on this timely, pressing topic.

However, since no members of the media were interested enough in this issue, the only place you'll find news about the day's proceedings is 91 outcomes (http://91outcomes.blogspot.com), which today has eight new articles summarizing each of the day's presentations in plain, easy to understand language.



Please feel free to review, share, post, redistribute, link, republish, or otherwise spread this critically important news -- the goal of 91outcomes is simply to get accurate, timely, important information on Gulf War veterans' health out to the Gulf War veterans, their advocates, and their loved ones. If you do republish it, please just provide a link back to 91outcomes so interested parties can continue to get news on Gulf War veterans' health. If you want to link or otherwise provide direct access to 91outcomes from your organization or other website, this email constitutes specific and welcomed permission to do so -- Gulf War veterans aren't getting any news from VA about the issues that matter to them about their ongoing, disabling illness, so it's available here.

As you may know, 91 outcomes is neither a for-profit nor a non-profit enterprise -- it's simply a labor of love in order to fill a gaping void in news and information available to the 175,000 to 210,000, or about one-fourth of Gulf War veterans who have been ill and remain ill following our 1991 Gulf War service.

VA Notes Preliminary Research Success, Justifies Violation of Charter Requirements

Written by Anthony Hardie, 91outcomes

(Boston, Mass. - June 29, 2009) In a meeting of the Congressionally chartered Research Advisory Committee on Gulf War Veterans' Illnesses, Dr. William Goldberg of the federal VA's Office of Research and Development provided an overview of the VA's recent Request for Applications for research funding for Gulf war Illness Treatments.

He also noted the recent success small treatment trial for Gulf War Illness.

The VA-funded treatment trial involved the use of a Continuous Positive Airway Pressure (CPAP) machine in Gulf War veterans suffering from Gulf War Illness. While only "about four to eight veterans" participated in the study, the results were significant, albeit preliminary. The findings showed improved fatigue and cognition in Gulf War veterans suffering from Gulf War Illness.

Responding to a question from RAC Chair Jim Binns regarding why VA failed to adhere to the RAC's Charter, which requires that VA's research funding announcements must be provided to the RAC prior to issuance, Dr. Goldberg stated that the VA had to provide the Request for Applications quickly, and "literally wrote it in a matter of days."

According to the Charter of the Congressionally Chartered advisory committee, written consistent with the federal law creating the body,
Applications for the RFA are due July 15, 2009 and are accepted only from VA researchers. According to Dr. Goldberg, the VA therefore made the determination to make the RFA available only internally on the VA's Interanet, and not publicly on the Internet.

The RFA was made public on 91outcomes on June 25.

The Committee shall review all proposed [emphasis added] Federal research plans, initiatives, procurements, grant programs, and other activities in support of research projects on health consequences of military service in the Southwest Asia theater of operations during the 1990-1991 Gulf War. The Committee, consistent with law, shall have access to all VA documents and other sources of information it finds relevant to such review.

Improving the Quality of Life -- One Physician's Experiences in Treating the Symptoms of an Illness that has No Effective Treatments

Written by Anthony Hardie, 91outcomes

(Boston, Mass. - June 29, 2009) Dr. Meryl Nass, a practicing physician at the Mt. Desert Island Hospital, in Bar Harbor, Maine has learned through practice that since there is no recognized treatment or set of treatments for her Gulf War Illness patients, she has sought to find what works, focusing on treating the symptoms and trying treatments that treat similar illnesses known to work. Her goal is simple: improve the patient's quality of life.

In a study presented today in Boston before the federal Research Advisory Committee on Gulf War Veterans' Illnesses involving a records review of 20 of her Gulf War patients, 15 male and five female, Dr. Nass noted her findings included a host of diseases, illnesses, conditions, symptoms, and difficulty communicating.

Many other conditions were noted, including tinnitus, recurrent oral ulcers, and other firmly diagnosed conditions, rather than self-reported conditions.

She noted that the group of ill Gulf War veterans had an average of 13 diagnoses each, "which you don't see in other parts of the world," said Dr. Nass.

One-fourth had Type 2 diabetes, and many of them had hypertension. What struck Dr. Nass as unusual, however, was that those patients were mostly male, mostly non-obese, and were diagnosed with these conditions in their 30s -- all highly unusual for the conditions.

She found that central sleep apnea was common among her study group of ill Gulf War veterans.

Severe nausea, vomiting, or diarrhea was common in forty percent of her patients.

Dr. Nass noted that many of these veterans have Multiple Chemical Sensitivity, including to detergents, solvents, paints, glues, and many others. She has frequently seen food sensitivities in her patients with Multiple Chemical Sensitivities, which requires an elimination diet to determine what foods are impacting negatively on the patient.

Dr. Nass has found in her clinical practice that no one pharmaceutical or single group of pharmaceuticals has proved to be particularly useful for fibromyalgia, which she called, "a surrogate" for Gulf War Illness. However, while she said that treating fibromyalgia patients through a multi-system approach is often quite successful, she candidly noted that success in treating Gulf War Illness patients has been only about "30 to 40 percent" for whom quality of life was improved, though not enough so that they could go back to work.


Treating the Symptoms

In the absence of proven treatments for the underlying Gulf War Illness condition, Dr. Nass has seen "countless" Gulf War veterans suffering from Gulf War Illness. In seeking to improve their quality of life, Dr. Nass has combined a variety of approaches, using "patient-centered care", which she says is necessary because so many Gulf War Illness patients have difficulty remembering, particularly complex instructions.

She tries a comprehensive approach, including treating pain, sleep, nutrition, gastointestinal complaints, saying, "treat everything you can." Those treatmens include treating the symptoms of debilitating fatigue, cognitive issues, chronic pain, and respiratory, gastro-intestinal, and immunological problems among others.

Her methods also include having appointments that last longer than usual, providing handouts and writing exactly what care is needed, which is often complex -- necessary because of Gulf War Illness patient's significant cognitive issues.

She also uses a pain questionaire developed by the manufacturer of Oxycontin in order to assess the level of pain, which is a primary symptom for many veterans suffering from Gulf War Illness. She also creates a complete problem list that is used as a continuing guide to treatment.

And, Dr. Nass explains that it's important to test for conditions with similar symptoms, like Lyme Disease, Vitamin B-12 deficiency, thryoid function issues, and other problems unique to each patient.

"Every veteran is also emotionally wounded," says Dr. Nass, which requires especially compassionate care, a thorough review of the veteran's often extensive medical records, and geting a "good feel" for the patient and family.

She noted that she was surprised that while thyroid function appears normal in Gulf War Illness patients, prescribing thryoid hormone at about one-third the level normally produced by the thyroid has significantly reduced pain and some other symptoms in a number of her Gulf War Illness patients. She says it remains unclear why the veterans' thyroid hormones simply don't stop functioning.

During questions following her presentation, it was noted that the high levels of GERD (Gastro-esophageal Reflux Disease) in Gulf War Illness patients lead to the common prescription of proton pump inhibitors (PPIs), which can then result in a Vitamin B deficiency in Gulf War Illness patients. The Vitamin B deficiency then must also be treated.. Examples of PPIs include Prilosec, Prevacid, Aciphex, and Protonix.

She noted that sexual dysfunction in males with fibromyalgia has been successfully treated with biweekly testosterone injections. She has prescribed narcotic pain medications and ritalin -- usually used primarily for attention deficit -- with success in Gulf War Illness. She notes that she always addresses the psychological aspects of having a chronic multi-symptom illness like Gulf War Illness.

Dr. Nass stresses that she must write everything down for Gulf War Illness patients (but not fibromylagia patients) due to the memory loss and cognitive issues, and she retains a copy as the treating physician.


Limited but Important Successes

One Gulf War Illness patient Dr. Nass described from her Mt. Desert Island Hospital practice was still working, would overdo it, then stay several days in bed, then repeat the cycle.

While he's not able to return to the workforce, several of his symptoms have improved, he is now able to work physically two to four hours per day, he now has a good self-image, and his family life has improved -- in short, true to Dr. Nass's goal as a physician, his quality of life has improved.

Treatments may be ready for Gulf War Illness Treatment Trials

Written by Anthony Hardie, 91outcomes

(Boston, Mass. - June 29, 2009) Treatments for Gulf War Illness (GWI) may already be available and ready for testing in treatment trials, said Dr. Keith Kelley during a presentation today in Boston before the federal Research Advisory Committee on Gulf War Weterans' Illnesses.

Kelley is Professor of Immunophysiology in the Integrative Immunology and Behavior Program and Neuroscience Program and the Department of Animal Sciences at the University of Illinois at Urbana-Champaign.

During his presentation, entitled, The role of neuroinflammation in chronic illness, Dr. Kelley explained what it actually means "to be sick" from a scientific perspective, which includes increased temperature, decreased social and physical activity, and other effects, and noted that many of these correlate with key aspects of the current definition of Gulf War Illness, including affected learning and memory, mood changes, and unrelenting fatigue.

While there is currently a lack of treatments for Gulf War Illness, Dr. Kelley said he believes that the current neuroinflammation hypothesis of Gulf War Illness is worth testing because FDA-approved drugs to reduce neuroinflammation from pre-clinical animal studies are available. According to Dr. Kelley, neuroinflammation reduces appetite, motivation, increases exhaustive fatigue and sensitivity to pain, causes deficits in learning and memory, and induces depressive-like behaviors.

Dr. Kelley suggested that potential treatments that would be valuable to study with regards to the neuroinflammatory model of Gulf War Illness may include:

• Antibiotics
• New drugs for fibromyalgia
• Botanicals
• HMG-CoA reductase inhibitors
• Diet--soluable fiber (which increases Interleukin-1 (IL-1) expression in the brain)
• IDo Inhibitors now in Phase I clinical trials
• Exercise

According to Dr. Kelley's biography, his research interests include proinflammatory cytokines and hormones in the brain and in cancer and muscle cells:

"For the past 30 years, our laboratory has been involved in defining reciprocal systems of communication between the immune and central nervous systems. We currently are interested in defining receptor signaling pathways that occur following activation of receptors for both proinflammatory cytokines and growth factors in the brain and the periphery and the role of inflammation in mental health disorders. For the former, we have discovered the existence of intracellular crosstalk between receptors for proinflammatory cytokines (TNFalpha, IL-1beta) and hormones (IGF-I) in a variety of cells. This interaction reduces the ability of growth factor receptors to function in the presence of very low concentrations of proinflammatory cytokines.

"The result is that the biological response of cells to a growth factor, whether it is the proliferation of cancer cells or the differentiation of muscle progenitor cells, is reduced in the presence of proinflammatory cytokines. Collectively, these data show that the biological properties of a classical hormonal growth factor receptor are directly regulated by proinflammatory cytokines from the immune system. For the second major emphasis in our laboratory, major research projects are aimed at determining the actions of proinflammatory cytokine receptors that are involved in sickness behavior, depressive-like behavior and memory. Brain inflammation causes symptoms of sickness that are usually associated with microbial infections, which is likely to make an important contribution to the comorbid behavioral and psychological disturbances that occur in the elderly.

"We have shown that IL-1beta and TNFalpha serve as communication molecules between the immune and central nervous systems. In contrast, anti-inflammatory cytokines in the brain, such as IL-10 and IGF-I, reduce behavioral symptoms of sickness following infection. We now are exploring the influence of aging on development of depressive-like behaviors in mice because one in five individuals over the age of 65 suffer from depressive disorders. This is more than twice the prevalence found in the general population.

"A likely mechanism for the increased prevalence of depressive disorders during aging is a reduction in the synthesis of serotonin, a key neurotransmitter in the regulation of mood, caused by proinflammatory cytokines acting in the brain. This action is mediated by immune-induced activation of the tryptophan-degrading enzyme, indoleamine 2,3 dioxygenase (IDO). This process decreases the bioavailability of tryptophan for the synthesis of serotonin.

"We are measuring IDO enzymatic activity, tryptophan and its metabolism (serotonin, 5-HIAA, kynurenine) in discrete brain regions of aged mice given either LPS or BCG. The major health impact of our research is directed at cognitive function, affect and muscle wasting in AIDS, cancer and aging."

Immune System in Ill Gulf War Veterans "Remodeled", Research Shows

Written by Anthony Hardie, 91outcomes

(Boston, Mass. - June 29, 2009) Research findings show immune system "remodeling" in blood and saliva samples of ill Gulf War veterans, including clear abnormalities in their immune system function and response and neuroendocrine balance, said Dr. Gordon Broderick of the University of Alberta in a presentation today in Boston before the federal Research Advisory Committee on Gulf War Veterans' Illnesses.

Using highly detailed data and analyses, the study found that GWI subjects can be distinguished from healthy veterans (and from CFS) by their neuroendocrine-immune status, and that differences can be amplified by studying response to exercise by looking for diagnostic features and illness processes.

At the intracellular level, Interleukin-5 (IL-5), Tumor Necrosis Factor-alpha (TNFa), and IFN were substantially elevated, as was Interleukin-6 (IL-6) plasma in vivo. The level of cytokines as a broad sectrum response -- which are a marker of inflammation in the body -- is greatly increased in Gulf War veterans with GWI with relation to key immune system markers following exercise .

GWI subjects are distinct in their immune response to excercise, and most significant at rest. The findings note that cytokines in combination and across time are are entirely distinct between the GWI and control groups, leading to an ability to precisely identify those suffering from GWI using their immune system markers found in the blood.

At the cellular level of Gulf War veterans with GWI, the research found that their immune system does respond to an exercise challenge, but its response is significantly more diffuse and
disorganized than the immune response among healthy study controls.

The research suggests that the team may have developed a working model for diagnosing Gulf War illness through neuroendocrine-immune system markers in ill Gulf War veterans' blood and saliva. Dr. Broderick believes that his research will help lead to treatments for Gulf War veterans suffering from Gulf War Illness.

Dr. Broderick's current research on Gulf War Illness is funded by the U.S. Department of Defense Congressionally Directed Medical Research Program.

Gulf War veterans' blood shows illness worsens with exercise

Written by Anthony Hardie, 91outcomes

(Boston, Mass. - June 29, 2009) Research findings presented today in Boston to the federal Research Advisory Committee on Gulf War Veterans' Illnesses noted similarities between Gulf War Illness and Chronic Fatigue Syndrome. Most significantly, the research findings showed that following an exercise challenge, Gulf War veterans had genetic and other measurable biological markers showing not only significant abnormalities related to pain, sensory perception, and the functioning of the immune and endocrine systems, but that these abnormalities dramatically worsen following exercise.

Dr. Nancy Klimas, a distinguished researcher in Chronic Fatigue Syndrome (CFS/ME), Gulf War Illness, and related health issues who is at the Miami, Fla. VA Medical Center, today presented her team's research findings in a public presentation entitled, Impaired immune function in Gulf War Illness.

Her most recent study involved issues surrounding the study of multi-symptom illness with a multi-system pathogenesis, which are the same for GWI and CFS. The study involved an exercise stressor model, with sampling before, at peak, and four hours after an exercise challenge using an exercise bike and a VO2 submax challenge. Blood and saliva samples were taken throughout from the matched ill Gulf War veterans, Chronic Fatigue patients, and health controls. A comprehensive set of genomic and other data was developed from the samples.

CD26+ lymphocytes were found to be elevated in both CFS and GWI, with the highest level in GWI. The findings also showed a reduced sDPPIV/CD26 in blood plasma, even more reduced than in CFS, which is reduced from the healthy population.

Preliminary findings in new, ongoing research further suggest that in ill Gulf War veterans, hundreds of genes are abnormal at baseline, during an exercise challenge, and at four hours following exercise, with the abnormalities worsening to nearly double at rest following exercise. It is notable that these findings correspond with the reported experiences of ill Gulf Ware veterans. Pain, sensory perception, and numerous immunological, endocrinological and other processes were abnormal following the exercise challenge.

While these finding are only preliminary, they suggest that there are significant abnormalities in Gulf War veterans' inflammation, fatigue, and other symptoms, that they are much more abnormal than the abnormalities found in CFS patients. They also show that unlike CFS patients, whose abnormalities drop back nearer to normal after resting following exercise, Gulf War veterans get steadily worse.

Dr. Klimas bases her conclusions on the research finding, concluding that CFS and GWI are similar, but GWI patients are sicker. Perhaps most significantly, and unlike CFS patients, GWI patients "fail to recover" following an exercise challenge, instead dramatically worsening.

Dr. Klimas agreed that it is unclear whether the findings show the disease itself or the results of GWI. However, she believes that ongoing research will show the way to GWI treatments.

According to the official biography for Dr. Klimas:

Dr. Klimas, a director of the laboratory, is board certified in internal medicine and diagnostic laboratory immunology. She is also the director of the Allergy and Immunology Clinic, and is a
licensed laboratory director in Florida. Dr. Klimas is Director of Research for the Clinical AIDS/HIV Research at the Miami Veterans Affairs Medical Center.

A leader in the field of Chronic Fatigue Syndrome (CFS) research, Dr. Klimas is the current President of the International Association for Chronic Fatigue Syndrome. Dr. Klimas is the principal investigator of the National Institute of Health's (NIH) Center for Multidisciplinary Studies of CFS Pathophysiology at the University of Miami. Dr. Klimas has been appointed to the inter-agency CFS Coordinating Committee, chaired by the Surgeon General of the United States. She is the founding editor of the Journal of Chronic Fatigue Syndrome. Recent publications include 123 peer reviewed papers, 3 books and 19 invited chapters.

Minneapolis VA Study Shows Blood Abnormalities in Ill Gulf War Veterans

Written by Anthony Hardie, 91outcomes

(Boston, Mass. - June 29, 2009) Gulf War veterans have measurable blood abnormalities related to chronic inflammation and abnormal immune responses, according to a ongoing research finding presented by Dr. Ronald Bach, Ph.D, FAHA, of the Minneapolis VA Medical Center, at today's RAC meetings at the Boston University School of Public Health.

Dr. Bach noted that the unusual Tissue Factor findings, found while screening for biomarkers of illness in Gulf War veterans, are related to chronic inflammation and immune response abnormalities in Gulf War veterans. According to Dr. Bach's ongoing research, there are notable abnormalities in tissue factor and chronic coagulopathies, suggesting the possibility of a hyperactive coagulation in the blood of ill Gulf War veterans.

Earlier research included a review of chronic symptoms and medical records of study participants, and sowed significantly increased blood levels showing higher coagulatory measures in ill Gulf War veterans, concluding that there was indirect evidence of coagulation system activation in Gulf War veterans and direct evidence of significant abnormalities.

Dr. Bach stated that his research finding are "unprecedented," with most Gulf War veteran subjects enrolled in the study had abnormally high levels of thrombin-antithrombin complex, high levels of thrombin-antithrombin complex, D-dimer, and factor VII antigen, resulting in a hypercoagular state. Dr. Bach concluded that these unusual findings may represent a heretofore unknown state of blood coagulation among ill Gulf War veterans, and may serve as a diagnostic biomarker for ill gulf War veterans.

His ongoing research goals are to be able to diagnose Gulf War Illnesss with blood tests, and to evaluate potential therapies that would help ill Gulf War veterans.

Dr. Debra Buchwald, Professor of the University of Washington Department of Medicine, Director of the Center for Clinical and Epidemiologicl Research, and a newly appointed member of the panel, noted concerns about the definition and concerns that some veterans with other veinous, thrombotic and related conditions might be misdiagnosed with these biomarkers. Dr. Bach responded that only one tissue factor "jumped out," that the Gulf War veterans he studied were not suffering from these conditions, and and that the Gulf War veterans in the study are a different kind of chronic "compensatory" process whereby the factors being measured are perpetually increased to compensate for something unique in ill Gulf War veterans.

Dr. Bach noted that his funding for new research, funded though a scientist- and Gulf War veteran-reviewed research funding process of the U.S. Department of Defense Congressionally Directed Medical Research Program, begins on July 1st, and his further studies are expected to reveal more about these "significant" abnormal findings in the blood markers in ill Gulf War veterans.

Dr. Meryl Nass, an attendee at the advisory committee review, noted her concerns about one of the measured factors, D-dimers. However, Dr. Bach responded that while he shares this concern, that the other measurable abnormalities are "significant".

Dr. Bach and his reasearch team continue to seek additional Gulf War veterans near Minneapolis, Minn. for the ongoing research. Dr. Bach can be contacted at ronald.bach@med.va.gov.

Harvard Study Shows Increased Symptoms in Kuwaitis that Mirror Gulf War veterans' symptoms

Written by Anglico.
Monday, June 29, 2009.

(Boston, Mass. - June 29, 2009) University Professor Dr. Douglas Dockery of the Harvard University School of Public Health kicked off the RAC's morning presentations with a presentation on Harvard's Kuwaiti oil well fire studies.

Beginning in 1991, Harvard researchers on the ground were measuring environmental impacts of the Kuwait oilwell fires. Later that year, Harvard organized an international conference on the
health effects of the oil well fires and environmental contamination.

The first Kuwait oil well fire was on February 10, 1991, about two-thirds of the way through the 1991 Persian Gulf War, which began in the early morning hours of January 17 of that year and
ended on February 27. Most of the oil well fires were ignited by Iraqi forces in late February 1991, as they retreated in advance The last of the oil well fires were finally extinguished on
November 6, 1991.

Dr. Dockery noted several unique characteristics, including that Kuwait keeps a complete registry of Kuwaitis from birth to death, which were carried safely out of the country at the time of the invasion and that Kuwait paid a stipend to Kuwaitis who remained in country during the invasion and occupation, thereby allowing for easy identification of those who were thus exposed to Gulf War environmental hazards during the war.

According to Dr. Dockery, who serves as Chair of Harvard's Department of Environmental Health, and Professor of Environmental Epidemiology, 37 percent of the 576,861 Kuwaitis received a stipend for having stayed in Kuwait during the invasion and occupation showing which Kuwaitis were remained in Kuwait and had Gulf War exposures. Most of that population centered in Kuwait City and along the coast. About two-thirds of the Kuwaiti population were non-nationals, and most left during the war.

Harvard conducted a public health study, including face-to-face interviews at home between December 3, 2003 and January 29, 2005, with interviews of next of kin for those who were
deceased or unable to answer. The extensive survey included the location of residence during the invasion and occupation, what their experiences were during that time, medical symptoms
before and after the invasion, and date of death for those deceased, and a comprehensive health history.

The study noted symptoms related to trauma and stress, including increased rates of heart attacks, colitis, and Post-Traumatic Stress Disorder (PTSD) symptoms. Increased rates of Chronic Obstructive Pulmonary Disease (COPD) were also noted among those with high Gulf War trauma and stress.

The study showed a host of increased health conditions and symptoms, unrelated to trauma and stress, in the Kuwaiti population who remained during the invasion and occupation. The highest rate of symptoms included fatigue, including severe fatigue, headaches, joint pain, and moodiness. Other conditions that were ranked high included sleep problems, unwellness after exercise, feeling not rested, muscle and body pain, dizziness, light sensitivity, breathing trouble, problems concentrating, memory problems, depression, irritability, anxiety, sinus problems, hand-shoulder and arm or leg pain, back problems, and gas.

It was noted by a member of the RAC that nearly all of these symptoms and conditions are among those most commonly reported among Gulf War veterans.

Anthony Hardie, a Gulf War veteran member of the panel, noted that he and "countless other Gulf War veterans" in Kuwait following the war experienced oil well fire smoke so thick it could be seen "in front of [his] hand" as it wafted by. He noted that his location was near the Kuwaiti International Airport in heavily populated Kuwait City, and that all the symptoms ranked as high were virtually the same as experienced by him and countless other ill Gulf War veterans.

According to Dr. Dockery's Harvard University School of Public Health biography:

Dr. Dockery and his colleagues have studied the health effects of air pollution exposures in populations who have been followed for up to twenty-five years. That research has increasingly
pointed to combustion-related particles as being causally linked to increased morbidity and mortality even at the relatively low concentrations observed in developed countries today. Dr.
Dockery and his colleagues have reported that episodes of particulate air pollution are consistently associated with increased daily mortality, increased hospital admissions and emergency room visits, exacerbation of asthma, increased respiratory symptoms and lower lung function. Long-term follow-up studies have shown particulate air pollution is associated with shortened life expectancy in adults and increased chronic respiratory illness and lower lung function in children. This research has led to the current debate on the role of particulate air pollution in producing adverse effect effects and to the re-evaluation of air quality standards both nationally and internationally.

Dr. Dockery's current research is attempting to more specifically identify the chemical and physical characteristics of those particles responsible for the observed adverse health effects. Current studies also are attempting to understand the pathways of acute cardiovascular events associated with air pollution exposure and to link these epidemiologic finding with toxicologic studies of particle effects. He also is assessing the health benefits of air pollution controls.

In addition, the methods developed to assess air pollution health effects epidemiologically are being applied to other environmental hazards including contamination of water supplies.

RAC Committee Begins, Chairman Binns Recognized

Written by Anthony Hardie, 91outcomes

(Boston, Mass. - June 29, 2009) The Congressionally chartered federal Research Advisory Committee on Gulf War Veterans' Illnesses (RAC) series of two-day meetings kicked off with an overview of the presentations to come from Dr. Roberta White, Scientific Director of the RAC, Professor and Chair of the Department of Environmental Health at Boston University School of Public Health, and a neuropsychologist with expertise in environmental and occupational epidemiology.

Dr. White summarized the presentations, which are focused on treatments for ill Gulf War veterans, who, according to the federal VA, number between 175,000 and 210,000 of the 697,000 who served in the 1991 Gulf War.

Dr. White recognized RAC chair Jim Binns for his work on behalf of ill Gulf War veterans, which met with resounding applause from the members of the committee, and veterans and members of the public in the audience.

Binns, who is a former Principal Deputy Assistant Secretary of Defense for International Security Policy, former chairman of Parallel Design and past president of ADR Ultrasound (two medical imaging manufacturing companies that he led from startup to merger), a graduate of Stanford University and Harvard Law School, and a Vietnam veteran, has served as the RAC's chair since its formation in 2002 at the direction of an act of Congress.

Binns has worked both publicly and behind the scenes to help direct the federal government's attention to treatments for Gulf War veterans' illnesses, including involving top scientists, researchers, federal government officials, Gulf War veterans, and Members of Congress and their staffs in the efforts.

RAC ready to meet tomorrow: Treatments for Gulf War Illnesses Top the Agenda

Written by Anthony Hardie, 91outcomes

(Boston, Mass. - June 28, 2009) Doctors and researchers from Harvard, the University of Illinois at Urbana-Champaign, the International Brain Research Foundation, and the Miami, Minneapolis and Boston VA Medical Centers are among the presenters for tomorrow's meetings of the the Congressionally chartered federal Research Advisory Committee on Gulf War Veterans' Illnesses (RAC).

The RAC's members, scientists and doctors, Gulf War veterans, and members of the public will hear two days of key presentations and discussions beginning tomorrow morning, June 29th, at 8:00 a.m., on the campus of the Boston University School of Public Health in Boston, Mass.

The RAC has a full agenda focused on treatments for Gulf War Illness, fibromyalgia, brain injury, lung function and disease following exposure to burning Kuwait oil well fires, and other Gulf War veterans' illnesses.

According to the U.S. Department of Veterans Affairs (VA), between 175,000 and 210,000 Gulf War veterans, out of a total of 696,842 troops who served in the 1991 Gulf War. are afflicted by chronic multi-symptom illness, commonly known as Gulf War Illness or Gulf War Syndrome.

91outcomes will be posting live from the RAC meetings, which have never before received comprehensive news coverage. Coverage will include overviews of the presentations and breaking news, live as it happens.

NJ Center would be dedicated to Gulf War Illness, other diseases

Editor's Note: The bill discussed in the article below, New Jersey State Assembly's AR202, has an identical bill in the New Jersey State Senate, SR133. New Jersey and other Gulf War veterans may find this of particular interest due to the proposed Center's focus on Gulf War Illness. New Jersey residents can find their state legislator using the Legislature's online service.

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Bill to Fund Neuroendocrine Immune Disorder Center of Excellence in New Jersey OK’d by Assembly, Now Before NJ House

by Rebecca Artman of PANDORA*
June 27, 2009

Research center would be dedicated to ME/CFS, fibromyalgia, Gulf War Illness, Lyme disease, MCS, and other environmental illnesses.

Sat., Jun 27, 2009, via the Co-Cure Listserv: Fantastic news! The New Jersey Assembly has unanimously passed Assembly Resolution 202 to fund a Center of Excellence in New Jersey for Chronic Neuroendocrine Immune Disorders - which include CFS, FM, and related illnesses. [See the full text, attached below, and] link to www.njleg.state.nj.us/bills/BillView.asp for full information on this resolution. The Assembly voted unanimously for this legislation.

The bill is now going to the New Jersey House as Senate Resolution 133. Link to www.njleg.state.nj.us/bills/BillView.asp for the full details.

So if you know anyone in New Jersey, now is the time to encourage them to contact their state senators to fund a New Jersey Center of Excellence.

The Nevada Center of Excellence - spearheaded by Annette Whittemore, was the first such Center of Excellence to be established. Placing another Center of Excellence in New Jersey will allow for networking opportunities and also be a resource for patients on the East Coast of the U.S.

PANDORA Founder Marla Silverman, Board Member Dr. Ken Friedman, PhD, and others have been working tirelessly on this project, and PANDORA will close its offices to all other business for the next six weeks to focus on this project.

Below is the wording of the Resolution.

- Rebecca Artman, Public Policy & Community Advisor, PANDORA, Inc.
___
* PANDORA - the non-profit Patient Alliance for Neuroendocrineimmune Disorders Organization for Research and Advocacy – is based in Coral Gables, Florida.
____________________________________________

ASSEMBLY RESOLUTION No. 202
STATE OF NEW JERSEY 213th LEGISLATURE
INTRODUCED MAY 21, 2009

Sponsored by:
Assemblyman UPENDRA J. CHIVUKULA, District 17 (Middlesex and Somerset)
Assemblyman HERB CONAWAY, JR. District 7 (Burlington and Camden)
Assemblywoman CONNIE WAGNER District 38 (Bergen)

SYNOPSIS
Urges Governor and memorializes Congress to encourage establishment of research center in New Jersey dedicated to chronic neuroendocrine immune disorders.

CURRENT VERSION OF TEXT as introduced.
An Assembly Resolution urging the Governor and memorializing Congress to encourage the establishment of a research center in New Jersey dedicated to chronic neuroendocrine immune disorders.

Whereas, Neuroendocrine immune disorders (NEIDs) currently include Chronic Fatigue Syndrome/Myalgic Encephalopathy, Fibromyalgia, Gulf War illness, Lyme disease, Multiple Chemical Sensitivity Syndrome, and other environmental illnesses;

And Whereas, Chronic Fatigue Syndrome/Myalgic Encephalopathy, Fibromyalgia, Gulf War illness, Lyme disease, and Multiple Chemical Sensitivity Syndrome have been characterized as being as disabling as Chronic Obstructive Pulmonary disease, End-stage Renal failure, and Rheumatoid Arthritis; and as life-impairing as Multiple Sclerosis, AIDS, and cancer chemotherapy treatments;

And Whereas, The mechanisms of transmission of NEIDs include parasite-borne infections;

And Whereas, The similarity of symptoms of NEIDs imply a common pathophysiology of these illnesses; therefore, discoveries and advances made in the etiology and treatment of any one of these illnesses will be applicable and beneficial to the other NEIDs because of their common pathophysiology;

And Whereas, An estimated 20 million American adults and children suffer
with NEIDs;

And Whereas, The time from illness onset to diagnosis of NEIDs is approximately three to seven years, except for Lyme disease which may take decades to diagnose;

And Whereas, There is mounting evidence of similarities of presentation and origins of NEIDs with Autism, Alzheimer's disease, Multiple Sclerosis, Lupus, Parkinson's and other autoimmune diseases;

And Whereas, Having a research center in this State is essential to:

• Promoting research into the etiology of, and therapeutic interventions for, NEIDs;

• Establishing treatment protocols and providing patient care for all individuals in the State of New Jersey afflicted with NEIDs;

• Serving as a repository for NEIDs research data, patient data and research publications;

• Serving as a resource for NEIDs researchers by sponsoring scientific meetings and encouraging discourse among researchers; serving as a tertiary resource for both physicians and patients in their efforts to manage NEIDs;

• And advancing both NEIDs research and patient care by disseminating the most recent advances in NEIDs research, diagnostics and treatment protocols; now, therefore,

Be It Resolved by the General Assembly of the State of New Jersey:

1. This House urges the Governor to encourage the establishment of a research center in this State dedicated to chronic neuroendocrine immune disorder;

2. This House respectfully memorializes Congress to encourage the establishment of a research center in this State dedicated to chronic neuroendocrine immune disorders.

3. Duly authenticated copies of this resolution, signed by the Speaker of the General Assembly and attested by the Clerk thereof, shall be transmitted to:

a. Governor Corzine and the Commissioner of Health and Senior Services; and

b. The Majority and Minority Leaders of the United States Senate, the Speaker and Minority Leader of the United States House of Representatives, and to every member of the United States Congress from this State.

STATEMENT
This resolution urges the Governor and respectfully memorializes Congress to encourage the establishment of a research center in New Jersey dedicated to understanding and treating chronic neuroendocrine immune illnesses (NEIDs) such as Chronic Fatigue Syndrome/Myalgic Encephalopathy (CFS/ME), Fibromyalgia, Gulf War illness, Lyme disease and Multiple Chemical Sensitivity Syndrome.

It is estimated by the Centers for Disease Control and Prevention (CDC) that CFS/ME affects between one and four million Americans and that 85% of individuals suffering with this debilitating and disabling illness have not been properly diagnosed.

The economic impact and loss of worker productivity in the United States due to CFS/ME, alone, is estimated to be over $9 billion per year. Census data, and the incidence rate of CFS in the United States, projects that an estimated 28,000 to 30,000 citizens of New Jersey will suffer from CFS/ME.

The symptoms of CFS/ME include flu-like symptoms (sore throat, fever, chills, tender neck and armpit lymph nodes, unrefreshing or non-restorative sleep, headaches, and post-exertional malaise lasting more than 24 hours), as well as body-wide muscle and joint pain, cognitive impairment, and short term memory loss.

The CDC reports that Fibromyalgia (FM) affects five million women, men, and children in the United States. FM is a condition characterized by body-wide muscle pain, tender points, sleep disturbance, cognitive impairment ("fibro-fog" or "brain fog"), overwhelming fatigue, swelling, joint pain, non-restorative sleep and migraine headaches.

According to the Research Advisory Committee on Gulf War Veterans' Illnesses, Gulf War illness (GWI) is estimated to affect between 175,000 to 200,000 U.S. veterans, some of whom have been suffering for over 17 years. GWI is characterized by multiple, diverse symptoms that include a combination of memory and concentration problems, chronic headache, unexplained fatigue, widespread pain, chronic digestive problems, respiratory symptoms, and skin rashes.

The CDC has announced that Lyme disease is the fastest-spreading infectious disease in the United States, and that New Jersey ranks third in the nation for reported cases of Lyme disease. Yet, Lyme disease is seriously underreported in the United States. Current literature suggests that co-infections associated with Lyme disease play a major role in precipitating chronic illness with symptoms that include flu-like symptoms, extreme fatigue, skin rashes, unexplained weight gain or loss, other endocrine disorders, urinary problems, sexual and reproductive dysfunction, gastrointestinal dysfunction, heart problems, joint pain or swelling, muscle twitching and muscle pain, peripheral neuropathy, vision and/or hearing problems, disorientation, psychiatric disorders, cognitive dysfunction, disturbed sleep, and poor balance.

Multiple Chemical Sensitivity Syndrome and other environmental illnesses are estimated to affect 10% of the American population. These illnesses have a variable, and overlapping presentation with other NEIDs, and have symptoms that include any combination of extreme fatigue/lethargy, muscle/joint pain, sleep disturbances, headaches/migraine headaches, sensitivity to light and noise, dizziness/vertigo, poor memory/poor concentration, nausea/digestive problems, sore throat, constant coughing, wheezing, skin rashes or burning/stinging eyes. -30-

Sarin, Pesticides Lead to Memory Loss

Written by Anthony Hardie, 91outcomes

(91outcomes.blogspot.com) - Families of victims of the 1994 sarin nerve agent subway attack by the Aum terrorist group held a memorial today in recognition of the anniversary of the attack, which took place 15 years ago today, on June 27, 1994.

Even while there was major news coverage of the anniversary events reflecting on the lives that were lost due to the attacks, the lasting effects of sarin exposures continue to affect the survivors.

In a 2001 study involving the survivors of the Aum subway attack, it was clear that even low-dose exposures to sarin led to signficantly declining, long-term memory loss -- one of the most commonly (and repeatedly) reported symptoms among ill Gulf War veterans.

However, despite confirmed exposures of at least 100,000 Gulf War ground troops to low-dose sarin following the Khamisiyah detonation, the federal VA has yet to provide presumptive service-connection for memory loss to the thousands of Gulf War veterans whose disabling memory conditions began in 1991.


Pesticides

Another source of cognitive disability in Gulf War veterans may be linked to the industrial-strength pesticides used by Gulf War troops on their uniforms, skin, and sprayed in work, sleeping, and eating areas.

A 2001 French study found that workers regularly exposed to low-level pesticides experienced decreases in memory, selective attention, verbal fluency, and abstraction.

Again, these are common symptoms among Gulf War veterans with Gulf War illness. And again, despite the recognized high-level pesticide exposures of virtually all Gulf War ground troops, Gulf War veterans suffering from cognitive impairments do not have the benefit of VA presumptive service-connection as should have been enacted nearly two decades ago.

Change is needed -- Soon.


A pair of 2001 articles, summarizing the Japanese subway attack survivors study, and providing an overview of the French pesticide study, follow.

The Tokyo Attacks in Retrospect

Sarin Leads to Memory Loss

Written by Ernie Hood, Environmental Health Perspectives, November 2001.

In the wake of the 11 September 2001 terrorist attacks on New York City and Washington, D.C., the threat posed by chemical and biological weapons has instantaneously evolved from hypothetical nightmare to clear and present danger. Under this new set of circumstances, any addition to the body of scientific knowledge about the health effects of chemical or biological agents is particularly timely. In this month's issue, a group of Japanese researchers led by Yuji Nishiwaki report the results of their investigation into the long-term physical and psychiatric effects of acute poisoning by sarin, a deadly military nerve gas [EHP 109:1169-1173].

Flashback to Tokyo. The 1995 sarin attack on the Tokyo subway killed 12, but exposure to the nerve gas may cause many more to suffer long-term memory effects.

Photo credit: Kyodo News International, Inc.

On 20 March 1995, members of the Aum Shinrikyo religious cult released sarin in the Tokyo subway, using umbrellas to puncture newspaper-wrapped bags of the gas as they left the trains. Twelve people were killed in the incident, and more than 5,500 required emergency medical treatment. Although several studies have looked at the acute clinical manifestations of sarin poisoning, the authors felt there was an urgent need to perform an epidemiologic study of the chronic effects of sublethal exposures to sarin.
The team examined rescue workers and police officers who had been dispatched to the scene and were exposed to sarin in the course of performing their duties--a group of subjects with similar occupational, socioeconomic, and educational backgrounds. The study included 56 exposed subjects from the Tokyo fire and police departments, who were subdivided into high- and low-exposure groups, and 52 nonexposed subjects of similar backgrounds from the same departments. The research was conducted three years after the exposure.
To assess neurobehavioral effects, the investigators administered five tests designed to measure psychomotor function and memory function. A significant causal relationship was discovered between exposure to sarin and memory disturbance. The exposed group performed less well, in a dose-effect manner, than the control group in the digit span memory test. In this test, the subject is asked to memorize a series of digits displayed on a computer screen at 1-second intervals and then enter the digits into the computer in the correct order within 10 seconds. Later, the subject is asked to enter the digits in reverse order. It was this backward digit portion of the test that uncovered significant memory loss in the exposed subjects. Other tests suggested other exposure-related memory effects, but the results were not statistically significant.
Subjects were also given psychometric tests to assess traumatic stress symptoms, in order to examine whether there was any correlation between psychologic stress and chronic physiologic effects. No such correlation was discovered.
The authors conclude that their findings suggest causality between the sarin attack and memory disturbance, although the mechanism behind that disturbance is unclear. They recommend further study of the link between sarin exposure and memory loss.

==============================

Pondering on Pesticides

Long-Term Low Levels Impair Thinking

Written by Tina Adler, Environmental Health Perspectives, August 2001.
As Homer wrote, "Wine can of their wits the wise beguile," but what of the grapes that make the wine--or rather, the pesticides with which they are treated? Isabelle Baldi of the Institut de Santé Publique d'Epidémiologie et de Développement in Bordeaux, France and colleagues went to their local vineyards to measure workers' cognitive well-being and see how it related to the amount of pesticides they had encountered over the years [EHP 109:839-844]. Previous studies had shown that high-dose pesticide poisoning can cause acute human health effects such as motor skill damage, impaired intellectual functioning, and memory loss. In this study, the first to assess long-term neuropsychologic effects of chronic, low-level pesticide exposures in a large sample of workers, Baldi and colleagues found many examples of impaired cognitive functioning among exposed workers.
The team interviewed 917 men and women, aged 43-58, between February 1997 and August 1998. Of the study participants, 528 had been directly exposed to pesticides through mixing or spraying over a mean of 22 years, another 173 had been indirectly exposed by contact with treated plants, and 216 had never been exposed. The pesticides used were primarily fungicides.

Lost in thought among the vines. A study conducted on vineyard workers showed for the first time that long-term low-level exposures to pesticides have measurable effects on cognition.

Photo credit: PhotoDisc

The team administered nine neuropsychologic tests to the workers, including the Mini-Mental Status Examination (which measures different cognitive components), the Wechsler Paired Associates Test of memory, the Benton Visual Retention Test, the Isaacs Set Test (which measures the ability to quickly generate lists of words in different semantic categories), and the Finger Tapping Test (which assesses motor speed). The team controlled for factors that could alter test scores, including educational level, age, sex, alcohol consumption, smoking, environmental exposures, and depressive symptoms.
Workers who were either directly or indirectly exposed performed worse on tests of memory, selective attention, verbal fluency, and abstraction compared with nonexposed workers. On a test of both selective attention and working memory, directly exposed workers were 3.5 times more likely to score low compared with nonexposed subjects. On a similar test of selective attention and mental flexibility, the exposed individuals were 3.1 times more likely to score low. The exposed men and women processed information less quickly than nonexposed colleagues, although performances of exposed workers were similar to those of the nonexposed if the tasks were slowed.
The study participants' symptoms were subclinical and didn't appear to interfere with their work, the team writes, and the participants didn't complain about their cognitive deficits. But they might run into cognitive problems as they age, Baldi notes. "This is why we planned a four-year follow-up of the population [starting in 2001] to assess evolution of performances," she says.
One surprising finding: although large amounts of alcohol are neurotoxic, the workers who drank moderately had better test scores than nondrinkers. Other studies have shown a protective effect of moderate wine consumption on cognitive performance. Baldi can't explain the finding, but notes that among these workers alcohol is considered "a noble product."

New Congressional Bill would Restore, Make VA Health Care Permanent for Gulf War Veterans

Written by Anthony Hardie, 91outcomes

(91outcomes.blogspot.com) - Using lessons learned after Vietnam, Congressional action after the 1991 Persian Gulf War provided automatic priority health care enrollment for Gulf War veterans, regardless of whether or not they had received the often difficult-to-win service-connection for their health conditions or met other priority health care eligibility criteria.

However, quietly at the end of 2002, these inclusive statutory health care enrollment provisions for Gulf War and Vietnam (herbicide) veterans were allowed to expire.

A new bill introduced in Congress in late June would restore eligibility for both groups, and make that eligibility for VA health care permanent.

Specifically, H.R. 2926 would amend title 38, United States Code, to direct the Secretary of the U.S. Department of Veterans Affairs (VA) to provide, without expiration, hospital care, medical services, and nursing home care for certain veterans of the 1991 Persian Gulf War.

The bill would also make permanent the eligibility for VA health care for certain Vietnam-era veterans exposed to herbicide -- a provision in law after which the Gulf War health eligibility provision was originally modeled.

Like certain Gulf War veterans, certain Vietnam veterans' eligibility for VA health care under VA Health Care Enrollment Priority 6 expired on December 31, 2002. It is unclear how many veterans might potentially be affected by the change, which would affect Gulf War and Vietnam veterans with lower or no enrollment status in the VA health care system.

Introduced on June 17, 2009 by Congressman Glen C. Nye, III (D-Virg., who represents the military-heavy Hampton Roads area), H.R. 2926 has been referred to the House Committee on Veterans' Affairs Subcommittee on Health. The bill is one of 107 bills that have been referred to the Subcommittee since the beginning of the 111th Congress in January.

Claims Deadline

Veterans of the 1991 Gulf War have also had to fight to seek five-year extensions to authorization to apply for undiagnosed illnesses, which also include three diagnosed conditions: fibroymyalgia; chronic fatigue syndrome; and, irritable bowel syndrome. In December 2006, the VA issued a federal rule change that extended presumptive compensation for U.S. veterans of the 1991 Gulf War by an additional five years, to a new December 31, 2011 deadline.

Unless this claims deadline is further extended, veterans of the 1991 Gulf War must submit service-connected disability claims for presumptive conditions, including claims for unexplained illness, chronic fatigue syndrome, fibromyalgia, and/or irritable bowel syndrome prior to this date or risk denial under more stringent rules thereafter.

H.R. 2926 addresses the health-care deadline for veterans of the 1991 Gulf War; the claims deadline is a separate issue.

A bipartisan bill

The bipartisan bill's four additional cosponsors include Rep. Steve Kagen, M.D. (D-Wis.), the House's only practicing physician, as well as Rep. Jerry McNerney (D-Calif.), Rep. Walter Minnick (D-Idaho), and Rep. Ileana Ros-Lehtinen (R-Fla.).

Constituents of other Members of Congress can contact their Representative to request that he or she cosponsor H.R. 2926 by using the online, Write Your Rep service of the U.S. House of Representatives.

RESEARCH FUNDING OPPORTUNITY: VA Announces RFA for Gulf War Illness Treatments Research

The federal VA has internally announced the following funding opportunity for research awards for new treatments for Gulf War Veterans' Illnesses.

Additional information is available at the end of this article, which summarizes key information about this Request for Applications.

Opportunity Number: CX-09-007: CSR&D Award for Research on New Treatments for Gulf War Veterans' Illnesses
Agency: Department of Veterans Affairs. Applications may be submitted from any VA medical center with an active research program.
Opening Date: 06/15/2009
Closing Date: Not later than 11 p.m. EST on 07/15/2009, submitted electronically (no paper applications accepted) via eRA Commons.
Peer Review Date(s): anticipated review in August or September, 2009.
Earliest Anticipated Start Date: October 1, 2009.
Expiration Date: December 31, 2010


APPLICATION INSTRUCTIONS OVERVIEW:

1. The most recent version of the VA-ORD Application Guide for SF424 (R&R) can be found at the following URL: http://vaww.research.va.gov/funding/electronic-submission.cfm

2. RFAs for electronic submission of research proposals to VA-ORD can be found at the following URL: http://vaww.research.va.gov/funding/rfa.cfm

3. Download Application Package from the following URL: http://apply07.grants.gov/apply/opportunities/packages/oppCX-09-007.pdf


RESEARCH OBJECTIVES

Veterans who served in the Gulf War in 1991 demonstrate increased incidence of several health conditions, including fibromyalgia, chronic fatigue syndrome, skin abnormalities and gastrointestinal disturbances (1). Fibromyalgia syndrome afflicts sufferers with persistent, widespread pain. Chronic fatigue syndrome leaves sufferers with a disabling loss of energy; the two conditions may be present within a single individual. Some ill Gulf War Veterans have reported chronic multiple symptom ilnesse(s) that do not meet case definition for either of these conditions.

There are currently two FDA-approved drugs [91outcomes Editor's Note: Actually, there are three -- the third is Savella (milnacipram HCI), another SNRI, approved by the FDA in January 2009. A fourth, sodium oxybate (Xyrem), has favorable ongoing research.] for treatment of fibromyalgia – pregabalin (Lyrica) and duloxitine (Cymbalta), a selective serotonin and norepinephrine reuptake inhibitor (SNRI). While it appears that both drugs have been employed to treat veterans suffering from fibromyalgia, it is not clear whether response rates are similar to those observed in treatment studies based on the general population. Similarly, there does not appear to be information on the relative efficacy of the two drugs within the Gulf War population, no information on whether a Gulf War Veteran who fails to respond adequately to one drug has a significant likelihood of benefitting from a switch to the other, and no information on whether the use of multiple drugs in combination can augment treatment effectiveness.

1 Eisen SA, Kang HK, Murphy FM, Blanchard MS, Reda DJ, Henderson WG, Toomey R, Jackson LW, Alpern R, Parks BJ, Klimas N, Hall C, Pak HS, Hunter J, Karlinsky J, Battistone MJ, Lyons MJ; Gulf War Study Participating Investigators. Gulf War veterans' health: medical evaluation of a U.S. cohort. Ann Intern Med. 142(11):881-890, 2005.

Other recent treatment trials have examined the use of exercise [sic]

The Clinical Sciences Research and Development Service solicits submissions of applications for studies that address the effectiveness in the Gulf War veteran population of these drugs, and of other treatments for which a plausible biological basis for anticipated efficacy can be established. Successful applications will propose a scientifically meritorious, controlled clinical trial or epidemiological investigation which addresses treatment of veterans who served in the theater of operations during the 1991 Gulf War with chronic multisymptom illnesses compared with fibromyalgia and/or chronic fatigue syndrome. Applications not employing appropriate populations of Gulf War Veterans will not be considered for funding.

Recent trials for treatment of chronic pain in fibromyalgia have included: transcranial magnetic stimulation of the motor cortex, melatonin, and nabilone. Proposals to test FDA-approved therapies for other chronic multisymptom illnesses in a Gulf War Veteran population may be submitted.

Proposals may also include identification or use of biomarkers (i.e., genetic, neuroendocrine, immunological, biochemical, physiological, etc.) that either predict or explain differences in response to the proposed treatment(s). Biomarker studies without an accompanying treatment trial will not be considered for funding.

The Merit Review Award Program is an intramural funding mechanism to support investigator-initiated research conducted by eligible VA-ORD investigators at VA medical centers or VA-approved sites. Merit Review Awards are one of CSR&D’s primary mechanisms for funding behavioral, epidemiological, and clinical research on disorders and diseases of importance to the health of veterans. The CSR&D purview includes interventional, experimental, and/or observational studies involving human subjects.

Proposals involving collection of medical histories, administering survey instruments or questionnaires, or performing medical procedures (including biopsies) or treatment regimens should be submitted to CSR&D. All clinical trials should be submitted to CSR&D, even if some specific aims in the proposal meet the purview of Biomedical Laboratory Research and Development (BLR&D). Proposals electronically submitted to CSR&D through Grants.gov will be peer-reviewed by Merit Review Panels (MRPs) to provide the Director of CSR&D with evaluations of the quality of the research proposed and make recommendations on scientific merit, budgets, and funding durations.


FUNDS AVAILABLE

Budget of Merit Review Awards: Proposals submitted under this RFA must be at least $50,000 per year, exclusive of equipment and non-clinician PD/PI salary, and for a minimum duration of 2 years. Budgets are capped due to budgetary constraints. Currently, the recurring budget (not including contact PD/PI salary and equipment) may not exceed $1,000,000 for the entire award period. Equipment request are limited to $50,000 for the entire award period and may not include patient care devices. Pilot projects may be submitted with a maximum budget of $100,000 per year. Only the salary for the contact PD/PI identified in Box 15 of the SF424 (R&R) Cover Component is excluded from the budget cap.

The research design is expected to be appropriate and efficient, with all budget categories well justified. In planning project budgets, applicants are reminded to adhere to ORD guidelines regarding allowable use of research funds for specific items.


CONTACTS FOR ADDITIONAL INFORMATION

VA encourages scientific/programmatic inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Reminder: Questions concerning electronic submission should be directed to Grants.gov or eRA Commons.

1. Scientific/Research Contacts: Inquiries related to Merit Review submission or review should be directed to the Chief of Program Review. The PD/PI may contact the appropriate portfolio managers with questions specifically related to scientific issues raised in the summary statement for a reviewed proposal or the scientific content of a proposal to be submitted. The associate chief of staff (ACOS) for research and development (R&D) should make all other contacts with CSR&D staff at VA central office (VACO), including questions relating to budget modifications noted in the summary statement. Contact information for Scientific Review Administrators for individual MRP may be found at http://vaww.research.va.gov/funding/electronic-submission.cfm

2. Financial Management Contact(s): Sara Clark at Sara.Clark@va.gov