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Friday, April 29, 2011

ACTION ALERT: FY12 Defense Authorization Bill, CDMRP Funding in Subcommittee Next Week

Defense Bill Coming Up Next Week in the House

The House Armed Services Military Personnel Subcommittee will draft its version of the FY2012 Defense Authorization bill next week.   Funding for the acclaimed Congressionally Directed Medical Research Program (CDMRP) is funded under the Defense spending bill.  The full House Armed Services Committee is expected to take up the bill the following week.

Now is the time to contact your U.S. representative and ask for their support to include provisions in the defense bill that would authorize a desperately needed increase in funding for the CDMRP’s Gulf War Illness Research Program.

FY11 funding for the CDMRP was steady from previous years at $8 million.  With the need to fund  as many as three consortia, in addition to treatment and other studies, a significant expansion in funding for the FY12 CDMRP peer-reviewed Gulf War Illness Research Program is really needed. 

In 2009, the VA’s Research Advisory Committee on Gulf War Veterans’ Illnesses (RAC-GWVI) recommended annual funding at $40 million.  Even still, funding has fallen far short of that realistic goal.

The Senate has consistently “authorized” spending on the program of $12 million, but the House has not yet “authorized” the program, making it that much harder to get annual “appropriations” for the program when that rolls around next. 

An authorization level of $40 million from the House would be ideal.

New Study to Look at Genomic Instability in GWI

Dr. Henry Heng awarded $900,000 to determine common genetic link among Gulf War Illness patients

DETROIT- For nearly two decades following the 1991 Gulf War, doctors noticed a trend in many of veterans of that conflict: an unexplainable cluster of symptoms including but not limited to chronic fatigue, memory loss, and depression. It wasn't until 2008 that a scientific panel from the U.S. Department of Veterans Affairs concluded that a third of American troops who served in the Gulf War were suffering from combinations of these symptoms, now recognized collectively as Gulf War Illness (GWI).

Now, Henry Heng, Ph.D., associate professor in WSU's Center for Molecular Medicine and Genetics, also of the Department of Pathology and Karmanos Cancer Institute in the School of Medicine, intends to discover GWI's mysterious biological cause. Heng was recently awarded a $900,000 grant from the U.S. Department of Defense to study whether GWI stems from genomic instability, which he believes is the common link among GWI patients.

After conducting an experiment for a program about Gulf War Illness broadcast on the Discovery Channel, Heng observed that patients who had GWI symptoms also tended to have extremely high levels of genomic instability, illustrated by increased chromosomal aberrations detected in their blood cells. "To our surprise, we found that all of the GWI patients tested showed extremely high levels of chromosomal abnormality that were as high or higher than some cancer patients," said Heng. The Discovery Channel program has received a great deal of attention from veteran groups.

Heng's hypothesis is also drawn from the genome theory, which suggests that complex disorders are not caused by individual genes, but rather by diverse factors not commonly shared and that affect the entire genome, which comprises the complete complement of genetic material of an organism within the nucleus and includes the genomic topology and the genetic network. When abnormal chromosomes form, the entire genome-defined system changes. "We propose that under the extreme environment of war, some individuals' genomes will become increasingly unstable, and war-induced genetic instability will lead to diverse disease traits that can be characterized as GWI," said Heng.

As his research on GWI progresses, Heng anticipates that his findings may make it possible to use simple blood samples to identify GWI patients. "Establishing GWI as a complex disorder and identifying its general causes will not only allow accurate diagnosis of this condition," said Heng, "but also move us toward reducing the prevalence of this condition in the future."

Collaborators include Saroj Chowdhury, M.D., and Christine J. Ye, M.D., physicians at the John D. Dingell VA Medical Center, and Joshua Stevens, Ph.D., postdoctoral research fellow in Heng's lab.

SOURCE:  Wayne State University, http://research.wayne.edu/rwnews/article.php?id=855

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CDMRP PUBLIC ABSTRACT
SOURCE:  CDMRP


PUBLIC ABSTRACT

Last year, a scientific panel through the Department of Veteran Affairs concluded that there is overwhelming evidence that Gulf War Illness (GWI) is a widespread problem affecting Gulf War veterans. Studies indicate that between 175,000 and 210,000 of the American veterans that served in the 1990-1991 Gulf War suffer from GWI. Despite this "official" acceptance, providing a solid scientific explanation connecting the multitude of symptoms and diverse causative factors displayed in GWI represents a great challenge. Increasing evidence indicates that many diseases are "complex", such as Cancer, Hypertension, Autism, and Schizophrenia, which are in contrast to the traditional concept that "common diseases are caused by common genetic causes." Likely, GWI represents a complex disease both from disease presentation and the causative factor point of view.


Traditional approaches to complex diseases have tried unsuccessfully to identify common causative factors such as key gene mutations that are purported to be responsible for the specific disease. Increasing evidence challenges this type of approach with regard to complex diseases. Many common diseases are actually caused by multiple and diverse genetic and non-genetic factors. Interestingly, this idea is now shared by many others who hypothesize that the complex theory may help our understanding of complex disease conditions like GWI.


In August 2007, our lab was invited to participate in a television program broadcast on the Discovery Channel, where we performed spectral karyotyping or SKY analysis (a cutting edge cytogenetic method used to study cancer abnormalities at the chromosome level) on blood samples taken from patients that were identified as having "Gulf War Syndrome," and to our surprise, we found that all of the GWI patients tested did show extremely high levels of a chromosomal abnormality that were as high or higher than advanced cancer patients.

In light of this preliminary evidence, we propose that under the extreme environment of war (including various factors for a given patient population) some individual's genomes will become increasingly unstable and war-induced genetic instability will lead to diverse disease traits that can be characterized as GWI. As a complex disease, despite variable symptoms, GWI patients do share a common physiological finding of an unstable genome that can be detected as chromosomal instability through a simple blood test.


Our research strategy is based on the complex system theory that states that various factors trigger the genetic system (genome) to become unstable in GWI (possibly only to those with a genetic predisposition to becoming unstable) and that an unstable genome causes the many varying symptoms associated with GWI. Using both in vitro and in vivo systems, we plan to link identified causative diverse factors to genome instability and the GWI status. If successful, this research proposal will establish the link between genome instability and GWI. Then, this link can be used to establish the underlying molecular basis of GWI, explaining the varied symptoms and causes, and also can be used to provide a method, through a simple blood test, to identify GWI patients and identify individuals with a predisposition to develop GWI.


We anticipate that if this study is successful that the use of our methodology applied through simple blood samples could be quickly adapted for use to identify GWI patients. A larger study would then need to be conducted to develop clinical diagnostic criteria. Finally, the establishment of the underlying genetic basis of GWI as a complex disease and identifying its causes will not only allow accurate diagnosis of this condition but move toward identifying susceptible individuals and limiting exposures of soldiers to potential hazards that will likely diminish the prevalence of this condition in the future.






Thursday, April 28, 2011

FUNDING AVAILABILITY JUST ANNOUNCED: $8 Million Available to Medical Researchers for Gulf War Illness Treatments, Biomarkers, and Case Definition Development

 

The acclaimed Congressionally Directed Medical Research Program (CDMRP) has issued its program announcements for funding available to medical researchers for studies related to Gulf War Illness (GWI). 

CDMRPS’s Gulf War Illness Research Program supports research focusing on the complex of symptoms known as Gulf War Illness (GWI), improving its definition and diagnosis, characterizing disease symptoms, and better understanding its pathobiology.  The program’s goals are to improve the health and lives of those suffering from GWI.

For the current fiscal year (FY11), total available funding is approximately $8 million, the same level as the last several years.

The links below are to the three award mechanisms, announced today.  Please note that submission deadlines are fairly tight, so interested researchers should act soon to potentially be funded under this exciting, cutting edge, Congressionally directed medical research program.

04/27/2011
DoD FY11 Gulf War Illness Clinical Trial Award
Dept. of the Army -- USAMRAA
W81XWH-11-GWIRP-CTA

04/27/2011
DoD FY11 Gulf War Illness Innovative Treatment Evaluation Award
Dept. of the Army -- USAMRAA
W81XWH-11-GWIRP-ITEA

04/27/2011
DoD Gulf War Illness Investigator-Initiated Research Award
Dept. of the Army -- USAMRAA
W81XWH-11-GWIRP-IIRA

Monday, April 25, 2011

Fifty Ill Gulf War Veterans Needed Needed for Important Atlanta-Based GWI Medical Research Project

Editor’s Note:  This is a very important Gulf War Illness (GWI) study related to a very significant hypothesis of the GWI disease process.


This study may have profound future implications for treating the approximately 250,000 GWI patients if it is indeed found that “mitochondrial dysfunction” is  part of the GWI disease process. 
The study was funded by the premier, veteran-acclaimed Congressionally Directed Medical Research Program (CDMRP), where all projects are selected using both expert medical researchers *and* ill Gulf War veteran consumer reviewers.


Please consider volunteering a little of your time (just 1.5 to 2 hours, in one single visit!) to help not just others, but potentially yourself as well!


--Anthony Hardie


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RESEARCH STUDY: GULF WAR SYNDROME (GWS/GWI)
Volunteers Needed – Travel costs covered


Dr. John Shoffner is a researcher at Georgia State University in mitochondrial disease who is performing a study of individuals diagnosed with Gulf War Syndrome. Blood and skin samples are being collected from 50 participants to characterize mitochondrial function in veterans with Gulf War Syndrome. The mitochondria have many functions that include changing the foods we eat into a usable form of energy known as ATP (adenosine triphosphate).

All the cells of our body use this energy to run the biochemical reactions that allow our cells to function properly. Hence, the mitochondria act as tiny power plants inside of every cell.
For more detailed information about this study including how to participate, please visit: www.medicalneurogenetics.com/MMD_in_GWS.asp


CONTACT INFORMATION
Updated with new contact information 1/25/2012:

Contact: Julie Decker 404-769-5163 jdecker@mnglab.com  
Contact: Maureen E Starnes, CPNP 678-225-0222 mstarnes@mnglab.com 


---------------------------------
Public Abstract: W81XWH-08-GWIRP-IIRA
Mechanisms of Mitochondrial Defects in Gulf War Syndrome


Gulf War syndrome (GWS) is associated with increased incidences of amyotrophic lateral sclerosis, pain syndromes, muscle complaints that include fatigue and myalgias, as well as other neurological symptoms. Approximately 100,000 individuals of the 700,000 veterans deployed in 1990- 1991 Gulf War have medical complaints consistent with GWS. Clinical manifestations are similar to those identified in Chronic Fatigue Syndrome (CFS).

Abnormalities in the part of the cell known as mitochondria have been delineated in GWS and CFS. We propose that GWS is determined by a complex interaction of variables that impair mitochondrial function that include genetic susceptibility, pre-Gulf War exposures, Gulf War associated exposures, and aging. This study will be the first comprehensive investigation of mitochondrial function in GWS. Our objective is to establish the cause for symptoms in affected veterans, develop testing that can more easily identify GWS, and ultimately develop treatment protocols for GWS.

The mitochondria have many functions that include changing the foods we eat into a usable form of energy known as ATP (adenosine triphosphate). All the cells of our body use this energy to run the biochemical reactions that allow our cells to function properly. Hence, the mitochondria act as tiny power plants inside of every cell.

These power plants also utilize about 95% of the oxygen that we breath. When the energy (ATP) is produced at normal levels, the cells function normally. When the energy (ATP) is reduced, the cells develop a variety of problems (analogous to a city during a brown out where energy dependent functions begin to fail). The central nervous system and muscle are often affected.

These diseases can have their onset at any age and can even be triggered by exposure to certain chemicals and drug exposures. Multiple lines of evidence from the literature and from patients studied in our laboratory suggest that the mitochondria are not functioning properly in GWS and in CFS. Hence, detailed investigation of mitochondrial dysfunction in GWS is a priority.

Over the last two decades, our group has been dedicated to working with patients with mitochondrial defects. Over the years, we described many inherited mutations and biochemical defects that impair mitochondrial function.

Our proposal is unique in that we integrate a variety of specialized laboratory techniques that characterize mitochondrial function into a comprehensive investigation.

Our proposal is designed to characterize mitochondrial function in 50 veterans with GWS using blood and skin cells. We will be investigating the skin and blood cells by characterizing precisely how mitochondria are working through detailed investigation of mitochondrial enzyme function, of mitochondria within living cells, of mitochondrial proteins, and of mitochondrial genes.

Mitochondrial mechanisms of disease could unify many of the diverse variables associated with GWS and lead to rational treatment strategies for these patients. Once the pathogenesis of GWS is firmly linked to mitochondrial dysfunction, we plan to initiate clinical trials for GWS as we are currently developing for patients with mitochondrial disease.

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Technical Abstract: W81XWH-08-GWIRP-IIRA
Mechanisms of Mitochondrial Defects in Gulf War Syndrome



Background: Gulf War syndrome (GWS) is associated with increased incidences of amyotrophic lateral sclerosis, pain syndromes, muscle complaints that include fatigue and myalgias, as well as other neurological symptoms. Approximately 100,000 individuals have medical complaints consistent with GWS. Clinical manifestations are similar to those identified in Chronic Fatigue Syndrome (CFS).
Mitochondrial defects are identified pathologically, metabolically, and genetically in some patients with CFS. GWS has significant evidence for mitochondrial dysfunction with abnormalities in exercise physiology, abnormalities in mitochondrial morphology, biochemical defects in mitochondrial function, abnormalities in free radical generation affecting mitochondrial integrity, gene expression in genes affecting mitochondrial function, and mtDNA mutations (inherited, somatic, and sporadic during embryogenesis). Gene expression abnormalities in CFS show abnormalities in genes that are related to mitochondrial function. Hence, investigation of mitochondrial dysfunction in GWS is a priority.

Objective/Hypothesis: The carrier rate of mitochondrial DNA (mtDNA) mutations in the general population is 1 in 200 individuals, making mitochondrial dysfunction a potentially important mechanism in GWS. Mitochondrial dysfunction is an important in the pathogenesis of GWS through the interaction of inherited and acquired nuclear DNA and/or mtDNA coded mitochondrial genes with environment exposures (pre-Gulf War exposures plus Gulf War associated exposures). Mitochondrial mechanisms of disease could unify many of the diverse variables associated with GWS and lead to rational treatment strategies for these patients. We have identified significant mitochondrial defects in CFS/fibromyalgia patients as well as a significant Complex V defect in a patient diagnosed with GWS.

Specific Aim I: After informed consent, blood samples and a skin biopsy will be obtained from 50 individuals diagnosed with GWS who have myalgia and fatigue patients.

Specific Aim II: Characterize mitochondrial cellular energetics in GWS patients relative to age and gender matched controls in blood and skin cells (fibroblasts) using the following approaches: (1) high resolution respirometry of intact cells, (2) quantitative analysis of individual mitochondrial proteins
(denatured, Western blot), (3) analysis of intact OXPHOS enzyme complexes and supercomplexes (nondenatured, Blue Native and Clear Native gels), (4) in gel enzyme activity assessment of intact OXPHOS enzyme complexes and supercomplexes (Clear Native gel, in-gel activity measurements), (5) mtDNA copy number quantitation to assess for defects in regulating mtDNA replication, and (6) cellular coenzyme Q10 quantitation (endogenous synthesis is impaired in certain types of mitochondrial dysfunction).

Specific Aim III: Assess the mitochondrial DNA (mtDNA) from each patient with GWS for mtDNA
mutations by whole genome sequencing of leukocyte and skin cell mtDNA. Based on the findings from
Specific Aim II, selected nuclear coded OXPHOS genes will be sequenced to assess for mutations that
increase susceptibility to GWS.

Study Design: Our laboratory has two decades experience with mitochondrial research and a large bank of over 25,000 patient samples (muscle, fibroblasts, EBV transformed lymphocytes, cerebrospinal fluid) that will allow statistical analysis of the data relative to gender/age matched control. In this prospective study, mitochondrial abnormalities in GWS cells are identified by comparison with tissue/cells from individuals with mutations known to cause mitochondrial dysfunction and controls.

Impact: Mitochondrial mechanisms of disease could unify many of the diverse variables associated with GWS and lead to rational treatment strategies for these patients. Once the pathogenesis of GWS is firmly linked to mitochondrial dysfunction, we plan to initiate clinical trials for GWS as we are currently developing for patients with mitochondrial disease.

Saturday, April 23, 2011

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

Help Wanted: VA

 

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Friday, April 22, 2011

Results of VA’s Gulf War Steering Committee Mixed, but Core of VA’s Research Efforts Appear to be Moving in Positive Direction

 

Gulf War Steering Committee - April 20, 2011

VA Gulf War Steering Committee, April 20, 2011.  Left to right:  Dr. Joel Kupersmith, director of the VA Office of Research & Development.  Steering Committee members:  Dr. Tilo Grosser, Dr. Jim O’Callaghan, Mr. Anthony Hardie, Dr. Roberta White, Dr. Max Buja, Dr. Richard Wenzel, Dr. Bob Kelch.   Not shown:  Dr. David Christiani, Dr. Loren Koller.

(91outcomes.com) -- As the sole Gulf War veteran on a panel otherwise composed of brilliant and accomplished scientists and medical doctors who essentially volunteer for this service to Gulf War veterans, I found this week’s meeting of the VA’s new Gulf War Steering Committee to have been of mixed results, but that many VA officials appear to be moving in a positive direction for Gulf War veterans still suffering the ill health effects of their military service two decades after the 1991 Gulf War.

Perhaps the most important topic of discussion surrounded the creation of a strategic plan to guide VA’s future Gulf War health research.

In the past, VA’s Gulf War research portfolio was fragmented, filled with gaps and overlaps, and excessively focused on stress and other issues unrelated to improving the health and lives of the approximately 250,000 GWI patients. Gulf War veterans justifiably were alienated and felt disregarded by a VA that spent hundreds of millions of dollars on “research” that resulted in absolutely nothing to offer GWI patients to help improve their health and lives.

This week’s meeting , however, suggested that the new VA, with its rapidly changing culture under Secretary Eric Shinseki that is aimed at advocacy and assistance for veterans, is genuinely trying to right the wrongs of the past.

Led by Dr. Joel Kupersmith, who oversees all of VA’s research programs, the Office of Research and Development (ORD) seemed open to most if not all of the Steering Committee’s recommendations on research content. VA’s ORD officials appeared to readily agree to the Steering Committee’s recommendation for an overarching mission for VA’s research program: To improve the health and well-being of Gulf War veterans while also seeking to learn the lessons necessary to help prevent similar health outcomes in the future.

While for many of us Gulf War veterans this is a no-brainer, for a VA long and justifiably despised by Gulf War veterans, this new openness comes as a breath of fresh air and the clear result of VA leadership based on open communication between Gulf War veterans, their medical and scientist advocates, and VA officials including those deep within the VA bureaucracy.

The new strategic plan is far from done, but the initial draft includes broad research goals of establishing a new GWI case definition, identifying plausible hypotheses for the underlying progression of the disease, identifying biomarkers and treatments, and improving coordination and communication with partners including VA’s Office of Public Health and Environmental Hazards (OPEIH) and Gulf War veterans’ beloved Congressionally Directed Medical Research Program (CDMRP) on Gulf War Illness.

Much less positive at this week’s meeting were discussions with OPEIH, where the left hand and the ORD right hand still don’t appear to be able to work together. Even more disappointing is that despite the apparent positive changes at ORD, the OPEIH clearly still has a long ways to go.

An OPEIH-developed national survey of Gulf War veterans was highly flawed – so much so that the advocacy-oriented Research Advisory Committee on Gulf War Veterans’ Illnesses (RAC-GWVI) called for an immediate halt to the survey because it would do far more damage than good.

A leading representative from the Office of the Secretary, Jeff Peters (who attended and actively participated in the entire day’s meetings!), explained that the RAC’s recommendations had been received and a “neutral” third party had been brought in to develop a final recommendation for implementation.  The final result should be concluded in a few weeks, he said.

This process will be a true test of the commitment of the new VA.  As I said at the meeting, “the proof will be in the pudding” if the final survey instrument has the many corrections needed, or instead if it remains the OPEIH’s old-VA style effort focused heavily on stress, depression, and anxiety while leaving most important Gulf War health questions unanswered.

Most disappointing is that OPEIH officials appear to still cling to justifying their inappropriate and flawed efforts.

For the long term, it is clear that the VA’s environmental health (OPEIH) has a long ways to go in adapting to the new VA focused on improving Gulf War veterans’ health and well-being and helping to prevent similar health outcomes in the future.

During the last two years, I have developed a deep respect for VA’s top leadership, who are clearly aimed not only at doing right by veterans in resolving these longstanding issues from past wars, but also have the tenacity and specialized knowledge, skills and abilities to make the needed changes within VA so that they will in perpetuity and not just subject to reversal by neglect under the next Administration.

I for one wish the Secretary’s office every hope for success in dramatically changing the culture in the OPEIH and any other holdouts of the old VA, where decisions have been made without regard, respect, or value for Gulf War veterans or the Congressionally-directed governing role of the RAC-GWVI that represents them and has had improving Gulf War veterans’ health and lives as a core component of its charter since its inception.

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More to come on other issues from the Gulf War Steering Committee in the coming days.

--Anthony Hardie

Discussion of Potential New Neutraceutical Treatment at International CFS Conference

(91outcomes.com) -- A new neutraceutical of potential benefit to patients with Gulf War Illness, Chronic Fatigue Syndrome (CFS), Irritable Bowel Syndrome (IBS) and other related neuro-inflammatory disorders was met with interest at the recent international conference on CFS.

According to the manufacturer Algonot,:

NeuroProtek® is a unique all natural oral dietary supplement in a soft gel capsule, which may reduce symptoms of gut and brain inflammation and nerve damage. NeuroProtek® uses an exclusive combination of flavonoids, based on the scientific research of Dr. Theoharides M.D., PhD, which have shown to reduce oxidative stress and inflammation both in the gut and the brain. NeuroProtek® is formulated to maximize the anti-inflammatory affects of flavonoids while also overcoming any absorption obstacles. NeuroProtek® contains the flavonoids: Luteolin, Quercetin, and Rutin. Unique to Algonot’s formulations is olive kernel oil, a powerful anti-oxidant that is instrumental in helping the body absorb and delivery the dry flavonoids found in each soft gel capsule. NeuroProtek® is free of the following allergens: artificial colors or dyes, flavors or sweeteners, corn, eggs, fish, heavy metals, milk/casein, peanuts, preservatives, salt, shellfish, starch, sugar, tree nuts, wheat/gluten and yeast. Our ingredients are not obtained from beef or beef by-products.

Flavonoids are natural molecules found mostly in green plants and seeds. Unfortunately, our modern life diet contains progressively fewer flavonoids and those that are consumed are difficult to absorb because they do not dissolve in water. Under these conditions, the average person cannot consume enough to make a positive health difference. There are approximately 3,000 flavonoids. Of those, NeuroProtek® contains three:

Luteolin (Chamomile > 95% Pure) is one of the three flavonoids found in NeuroProtek® . Luteolin was incorporated in this formula after published papers showed it is important in the body: as a free radical scavenger, an agent in the prevention of inflammation, an immune system modulator and it mimics a normal compound that protects nerve damage.

Quercetin (Saphora Plant > 95% Pure) is a natural non-acidic (flavanoid) with potent anti-inflammatory capabilities. Quercetin is added to NeuroProtek® to help relieve the swelling associated from inflammatory disease and protect from further damage associated with mast cell activation. The Quercetin used in NeuroProtek® is obtained from the saphora plant. Algonot decisively choose not to use the more common and less expensive source of fava beans, which could cause hemolytic anemia, particularly in people of Mediterranean origin.

Rutin (Saphora Plant > 95% Pure) is a glycoside of the flavonoid Quercetin. Like quercetin, rutin is extracted from the saphora plant and is a non-acidic natural flavonoid that adds additional anti-inflammatory qualities. Rutin helps liberate quercetin in the intestine, making absorption easier. Rutin has been shown to be the strongest antioxidant in studies.

Olive Kernel Oil (Unprocessed, MicroFiltered) Olive kernel oil is a potent low-acidic anti-oxidant that can help repair damaged tissues. This unique oil (a lipid) plays an important role in NeuroProtek® as it is used to increase the absorbability of these flavonoids. We use only virgin olive seed oil from the island of Crete.

While some benefit may be noticed shortly after starting NeuroProtek, it may take 6-12 months before measurable benefits are observed . NeuroProtek® does not require a prescription. NeuroProtek is not a cure. NeuroProtek is not an analgesic.

People considering using NeuroProtek should consult their doctor. Please print this information or request a packet of information to be sent to your doctor

Initial studies have suggested that NeuroProtek may be beneficial to children with autism.  Anecdotal reports suggest it’s helpful in patients with a wide variety of neuro-inflammatory and neurodegenerative disorders, including CFS, MS, and more. 

Broader investigations are now being pursued, according to Algonot:

“Given the encouraging outcome of trials to date, applications for randomized, double-blind, placebo-controlled clinical trials have been submitted by Dr. Theoharides to the National Institute of Health, and the Department of Defense.”

The cost is not cheap.  The recommended dose is:

“2 capsules per 20 kg (44 lbs) of body weight daily. This is the minimal recommended daily dose. One should not exceed 8 capsules per day regardless of weight.  The dosing schedule should be whatever is most appropriate for the person taking NeuroProtek®. For best results, doses maybe taken with meals and divided throughout the day.”

Thus, for a person weighing 175 pounds or greater, the full 8 capsules per day would be needed, requiring four 60-gelcap bottles for a 30-day supply.  The cost for four bottles is $150.35 (including shipping).    A shorter supply of one bottle of 60 gelcaps is $39 plus $6.95 shipping. 

Algonot has a generous refund policy, with a full refund within 45 days for up to four bottles if not totally satisfied. 

Of note, since this is a non-FDA approved neutraceutical, it is virtually certain that VA is unable to pay for it. 

If anyone with GWI or other Gulf War-related diseases decides to try NeuroProtek, please share a brief write-up of your experiences for publication here on 91outcomes

--Anthony Hardie

Wednesday, April 20, 2011

AP: New Guidelines Paving Way for Early Diagnosis, Possible Treatments for Cognitive Impairment Associated with Early Alzheimer’s Disease

(91outcomes.com) -  The Associated Press reports that new guidelines for Alzheimer’s Disease (AD) may help provide early diagnosis and treatment for the disease.  The criteria were developed by the National Institute on Aging and the Alzheimer’s Association. 

Many new diagnostic methods and tools are currently “in the pipeline,” along with possible treatments, says AP, though it’s reportedly too early to tell if they’ll be effective or useful.  

The earliest symptoms of AD include mild to moderate cognitive impairment, which is also one of the most frequent complaints among Gulf War Illness (GWI) patients.  According to AP:

“Marilyn Albert, a Johns Hopkins University researcher who led the [Alzheimer’s Disease] mild cognitive impairment panel, described this category as "people who have mild, progressive symptoms, changes in mental abilities, usually memory but not always memory" that stop short of full-blown dementia.”

If there is a relationship between AD and GWI, it remains unknown and speculative.

Read the full AP article here, which provides a fascinating insight into diagnostic methods and tools used in diagnosing the basis and possible diagnosis for cognitive impairment. 

--Anthony Hardie

Monday, April 18, 2011

VA’s Gulf War Steering Committee to Meet this Week

Flawed VA Gulf War Veteran Survey Proposal, Creation of a Strategic Plan to Guide Gulf War Health Research are Top Concerns to be Addressed

(91outcomes.com) - The VA’s fledgling Gulf War Steering Committee is set to meet this week Wednesday in Washington, DC. 

At the urging of the RAC-GWVI, the VA has proposed a “strategic plan" to guide Gulf War research.  While nearly 20 years late, it’s certainly better late than never to finally have a plan to guide research that to date has been piecemeal at best and entirely missing the health needs of Gulf War veterans at worst.

Much of the Gulf War Steering Committee’s discussion, which is scheduled to take up the meeting’s entire afternoon portion, will likely be aimed at repairing the badly damaged plan for a major VA survey of Gulf War veterans and creating a true strategic plan to guide VA in its health research related to Gulf War veterans.

Of great concern is the fact that the VA’s planned 2011 Follow-Up Survey of
Gulf War Era Veterans failed to involve the Steering Committee or the RAC, and therefore has many serious flaws that make it better to not do the survey at all if they’re not corrected. 

The morning portion of the Steering Committee’s day-long meeting includes the following presentations:

  • John Gingrich, VA Chief of Staff
  • Dr. Joel Kupersmith, VA Chief Research & Development Officer
  • Research Information Management System, by Holly Birdsall, VA Office of Research & Development (ORD)
  • Dr. Robert Jaeger, Acting Director, Deployment Health Research Program
  • Million Veteran Program (MVP) & Genomic Medicine Program (MVP) , by Dr. Timothy O’Leary, VA Deputy Chief Research & Development Officer
  • Congressionally Directed Medical Research Program (CDMRP), Gulf War Illness Research Program, by Dr. Melissa A. Forsythe, Colonel, United States Army (Ret.)
  • Office of Public Health and Environmental Hazards (OPEIH), by Dr. Michael R. Peterson, Chief Consultant, Environmental Health and Dr. Terry J. Walters, Director, Environmental Agents Service

Dr. William J. “Bill” Goldberg, Program Manager of the VA’s Gulf War Research Program will present VA’s proposed Draft Strategic Plan, which currently includes the five broad items posted below.

The members of the VA’s new Gulf War Steering Committee include five members of (or appointed by) the VA’s National Research Advisory Committee (NRAC), which encompasses all of VA’s medical research, and four members of (of appointed by) the VA’s Research Advisory Committee on Gulf War Veterans’ Illnesses (RAC-GWVI).

One of the GWSC’s RAC members – me – is the panel’s representative Gulf War veteran with GWI.

VA officials created the GWSC based on an action item in the internal VA Task Force on Gulf War Veterans’ Illnesses and the recommendation of the RAC-GWVI.

The new panel held its first meeting via teleconference in June, and its first in person meeting in Washington, DC in October.  This will be the Steering Committee’s third meeting.  

--Anthony Hardie, Gulf War Veteran Member of the VA Gulf War Steering Committee, RAC-GWVI, and CDMRP-GWIRP

As always, I’ll keep my fellow Gulf War veterans updated via here on 91outcomes. And as always, your thoughts and recommendations are *always* welcome and also as always, I will do my best to represent you on these issues that affect all of us.

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Draft Strategic Plan (3-Year) for VA Gulf War Research Program

1. Identify/test new symptomatic treatments for ill Gulf War Veterans

2. Identify therapeutic targets for development of new treatments for ill Gulf War Veterans.  Identify plausible hypotheses on the underlying causes and related pathways that might account for persistent symptoms.  Systems biology:

a. Genomics

b. Proteomics

c. Metobolomics

d. Animal models

3. Establish new case definition(s)

4. Identify biomarkers/diagnostics for ill Gulf War Veterans

a. State-of-the-art Neuroimaging

b. Genomics

c. Proteomics

d. Metabolomics

5. Improve coordination and communication with partners

a. VA Office of Public Health and Environmental Hazards (OPEIH)

b. Congressionally Directed Medical Research Program (CDMRP), Gulf War Illness Research Program

Saturday, April 16, 2011

FDA approves New Device for Chemo-resistant Brain Cancer

The FDA has approved a new treatment for gliogblastoma brain cancer utilizing electrical energy fields. 

The treatment is approved for more aggressive brain tumors that are resistant to chemotherapy and other treatments.

Brain cancer has been shown to be more prevalent among Gulf War veterans than their non-deployed Gulf War era veteran counterparts, particularly among those who were exposed to low-level sarin, cyclosarin, and likely also mustard gas following a U.S. demolition of chemical warfare agent-containing munitions at an Iraqi bunker complex at Khamisiyah, Iraq in March 1991.

According to a USA Today article, the NovoTTF device, “is a six-pound (2.75-kilogram) device that patients carry with them in a small bag. The electrical current is sent from the device to four electrodes attached to the patient's shaved head.”

Read more:  http://yourlife.usatoday.com/health/medical/cancer/story/2011/04/FDA-clears-first-of-a-kind-device-for-brain-cancer/46174922/1?csp=34news&utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+usatoday-NewsTopStories+%28News+-+Top+Stories%29&utm_content=My+Yahoo

Photos and more info on the device:  http://www.medgadget.com/archives/2011/04/device_for_treatment_of_brain_tumors_wins_fda_clearance.htmla

Friday, April 15, 2011

Final list of Cosigners to the FY11 Sanders GWI CDMRP Senate Funding Dear Colleague Letter


The following is the final list of all Members of the U.S. Senate signed onto the FY11 Sanders "Dear Colleague" request to provide FY11 Gulf War Illness treatment Congressionally Directed Medical Research Program (CDMRP) Funding:



  1. Akaka, Daniel
  2. Boxer, Barbara
  3. Brown, Sherrod
  4. Durbin, Richard
  5. Kerry, John
  6. Kohl, Herb
  7. Leahy, Patrick
  8. Murray, Patty
  9. Rockefeller, John D. IV
  10. Sanders, Bernie
  11. Schumer, Charles
  12. Snowe, Olympia
  13. Tester, Jon

Friday, April 8, 2011

Long Awaited VA Gulf War Research Program Manager Opening Announced


(91outcomes.com) -- The long awaited Gulf War Research Manager position at the U.S. Department of Veterans Affairs (VA) has been announced this week.

The need for a full-time VA research staff position position with a primary responsibility on coordinating, steering and improving treatment-focused Gulf War illnesses research was been sought and requested for some time by the Research Advisory Committee on Gulf War Veterans’ Illnesses (RAC-GWVI).

The VA position announcement says this senior program manager, “will be responsible for the overall direction, coordination, implementation, execution, control and completion of research projects ensuring consistency with Veterans Affairs strategy, commitments and goals, including OMR operating plan.”

The VA says the position will, “oversee, plan, develop and implement the Gulf War Veteran's Illnesses (GWVI)/Military Environmental Exposures (MEE) Research portfolio,” working, “in collaboration with the Department of Defense (DoD) and the National Institutes of Health (NIH) to develop standard definitions and measurement tools in all areas of GWVI research.”

According to the VA’s job announcement, the new GS-15 scientific position is located in the Office of Research and Development (ORD), “which aspires to discover knowledge, develop VA researchers and health care leaders, and create innovations that advance health care for our Veterans and the nation.”

Examples of specialized experience required by the position include: “expert knowledge in medical research and development, primarily environmental chemistry, environmental toxicology, epidemiology or biostatistics, as evidenced by an appropriate advanced degree, with an in depth knowledge of clinical, ethical, and regulatory. Applicants may not substitute education for the required experience.”

Important to  Gulf War veterans is this position is focused on the science of Gulf War veterans’ illnesses and not “stress,” a hot button issue that turned countless veterans against the VA over the course of many years.

Last Fall, a top-level VA task force on Gulf War issues recommended sweeping changes to modify VA’s “culture” to one of advocacy for Gulf War veterans. 

The complete Application Package must be submitted by 11:59 PM (EST) on Wednesday, April 20, 2011.

Veterans, researchers and clinicians can help ensure this critical position is filled by a well-qualified candidate by sharing this article and the VA position announcement with potential applicants.

--Anthony Hardie

---------------------

MORE INFORMATION: 

-Job Announcement:  http://jobview.usajobs.gov/GetJob.aspx?JobID=98370455&JobTitle=Health+Science+Specialist&where=washington%2c+dc&brd=3876&vw=b&FedEmp=Y&FedPub=Y&x=0&y=0&jbf571=7&jbf522=0601&selSubCat=0601&AVSDM=2011-04-06+08%3a02%3a00

Thursday, April 7, 2011

Restless Legs May be Symptom of Heart Issues

 

A new APOnline article about a new Mayo Clinic study suggests that Restless Legs may be a symptom – in some cases – of a thickened heart.  

That, in turn, can result in an increase risk of heart problems and stroke.

Read the full article here.

Tuesday, April 5, 2011

GWI and Other CDMRP Funding Fully Intact in Latest Continuing Resolution

 

Today’s news on the Congressional Continuing Resolution is good news for Gulf War  and other veterans and military service members : Gulf War Illness treatment focused research would be continued at $8 million, ALS research would be funded at the same level as GWI, $8 million, and MS research would be funded at $4.8 million.

The following is from the DOD explanatory chart for the latest House Continuing Resolution (CR) for the Congressionally Directed Medical Research Programs (CDMRP). 

The data is provided courtesy of Gavin Lindberg, Vice President for Legislative Affairs with the Health & Medicine Counsel of Washington (HMCW).

-------------

                                                                                                                                                                                                                 Budget Request      Recommendation  (in $1,000’s)

  • ALS     ---     +8,000
  • Armed Forces Institute of Regenerative Medicine   ---   +4,800
  • Autism Research    ---    +6,400
  • Bone Marrow Failure Disease Research Program   ---   +4,000
  • Duchenne Muscular Dystrophy   ---  +4,000
  • Global HIV/AIDS Prevention   ---    +10,000
  • Traumatic Brain Injury and Psychological Health     ---    +100,000
  • Global Deployment of the Force medical research funding – Department of Defense requested transfer to maintain full funding for the program     ---    +125,000
  • Gulf War Illness Peer-Reviewed Research Program    ---   
    +8,000
  • Multiple Sclerosis    ---     +4,800
  • Peer-Reviewed Alzheimer Research     ---    +15,000
  • Peer-Reviewed Breast Cancer Research Program    ---   +150,000
  • Peer-Reviewed Cancer Research Program    ---    +16,000
  • Peer-Reviewed Lung Cancer Research Program   ---    +12,800
  • Peer-Reviewed Orthopedic Research Program    ---   +24,000
  • Peer-Reviewed Ovarian Cancer Research Program   ---   +20,000
  • Peer Reviewed Vision research in conjunction with the DoD Vision Center of Excellence    ---    +4,000
  • Peer-Reviewed Prostate Cancer Research Program   ---    +80,000
  • Peer-Reviewed Spinal Cord Research Program   ---   +12,000
  • Research in Alcohol and Substance Use Disorders  ---   +5,200
  • SBIR to the core funded RDT&E    ---   +1,200
  • Tuberous Sclerosis Complex (TSC)   ---   +6,400 
  • Pain Management Task Force Research   ---    +4,000
  • Peer Reviewed Medical Research Program   ---   +50,000

TOTAL, DEFENSE HEALTH PROGRAM    (in $1,000’s)
Budget Request:  30,935,111    Recommendation:  31,382,198

 

--Anthony Hardie

Monday, April 4, 2011

CIA Remains Mum on Mandated Gulf War Declassification Review

A provision of the Intelligence Authorization Act for Fiscal Year 2010 requiring the U.S. Central Intelligence Agency to “conduct a classification review of the records of the Agency that are relevant to the known or potential health effects suffered by veterans of Operation Desert Storm,” has not yet been fully implemented.

It is unclear whether or if CIA officials have begun work on the review.

The language of the Act is as follows.

SEC. 341. REVIEW OF RECORDS RELATING TO POTENTIAL HEALTH RISKS AMONG DESERT STORM VETERANS.

(a) REVIEW.—The Director of the Central Intelligence Agency
shall conduct a classification review of the records of the Agency
that are relevant to the known or potential health effects suffered
by veterans of Operation Desert Storm as described in the
November 2008, report by the Department of Veterans Affairs
Research Advisory Committee on Gulf War Veterans’ Illnesses.

(b) REPORT.—Not later than one year after the date of the
enactment of this Act, the Director of the Central Intelligence
Agency shall submit to Congress the results of the classification
review conducted under subsection (a), including the total number
of records of the Agency that are relevant.

(c) FORM.—The report required under subsection (b) shall be
submitted in unclassified form, but may include a classified annex.

--Anthony Hardie

Friday, April 1, 2011

Boston Area GWI Study Now Recruiting– GWI Patients Needed

EDITOR’S NOTE:  The following was provided to 91outcomes from the study staff.  It looks to be an excellent study with strong potential for helping GWI patients, and was funded through the acclaimed CDMRP program on which several Gulf War veterans, including myself, serve.

--Anthony Hardie

------------------- 

CDMRP funded study, “The Effectiveness of Acupuncture in the Treatment of Gulf War Illness”, is now recruiting in Newton, MA

Principle Investigator: Lisa Ann Conboy MA MS ScD

DOD Award:GW080059

Is acupuncture an effective treatment for Gulf War Illness (GWI)?

The New England School of Acupuncture in Newton, Massachusetts is currently running a study testing the effectiveness of acupuncture for the symptoms of (GWI). Gulf War Illness (GWI) is a complex, poorly understood illness characterized by many symptoms, including fatigue after exertion, sleep and mood problems, difficulty concentrating, difficulty thinking and finding words, and musculoskeletal pain. Acupuncture is likely to be helpful in treating GWI because it has already been used successfully to reduce many of the key symptoms of GWI – fatigue, irritability, anxiety, insomnia, and pain. Acupuncture treatment is designed to treat each individual’s symptoms making it very well suited for treating the varied symptoms of GWI. Veterans will receive care that is directed specifically at their most distressing symptoms.

Though the specific cause of GWI is unknown, acupuncture’s analgesic and anti-inflammatory effects are likely to be helpful. Acupuncture seems to work, in part, on peripheral nerves near the site of injury, in the brain, central nervous system, and on the endocrine system, in ways that promote the body’s own efforts to reduce pain and heal even chronic injuries. Numerous studies have shown acupuncture is well tolerated by patients, safe, and cost-effective compared to routine care. The acupuncture for this study is provided by licensed acupuncturists with at least 5 years of clinical experience, and who have received 20-hours of training related to symptoms of GWI.

Our study team at The New England School of Acupuncture is currently recruiting subjects who report they have symptoms of GWI. Using questionnaires, physician assessment and medical histories, we will measure the severity of symptoms before beginning treatment, after 2 months, after 4 months, and after treatment is completed at 6 months. Based on previous acupuncture research on fatigue, stress, and pain, we expect this length of treatment will be enough for patients to receive significant benefit. We also plan to collect samples of blood from our volunteers that will help identify possible disease mechanisms for the illness and track the effects of treatment.

All subjects will receive free acupuncture treatments and a small travel stipend.

If you are interested in more information please

Call the study line at 617-558-1788 Ext. 269

Send the study staff an e-mail at: dodgwi@gmail.com

Review the consent form for more details about the study