What’s up in 2014? Federal funding still sucks, but it’s clear that the Research Foundations and non-profits are finding a way. As the list of studies or trials ending in 2014 indicates, we’re going to learn a lot about chronic fatigue syndrome this year.
UK Rituximab Trial Underway – Invest in ME has raised 280,000 pounds for the 350,000 pound UK Rituximab trial. The trial will be initiated following the Invest in ME conference this year.
Pridgen FM Antiviral Study Results to be Presented Soon - Will Pridgen’s antiviral approach to fibromyalgia revolutionize the way fibromyalgia is treated? The results of his multi-center Valtrex/Celecoxib fibromyalgia study are released on March 14th, hopefully paving the way for Phase III studies. Find out more about the study here.
CDC Multi-Site Experts Study Identifies Effective Treatments - Dr. Bateman’s report at the IACFS/ME on treatment effectiveness from the multi-site trial suggests the CDC may be ready in the not too distant future to report on what works best for ME/CFS experts. That report will hopefully open up treatment options for many patients not seeing those experts.
Major Electronic Database for Patients: OpenMedNet From the Open Medicine Institute Begins – ME/CFS patients will be able to enter treatment success and failure data – giving researchers access to important data – as this sophisticated system opens probably in the first quarter of this year. “This integrated, cloud-based system is designed to streamline data collection, sharing, and optimization and is ideal for clinical trial/research protocol execution.”
Clinical Data Analyses to Spur Studies on Effective Treatments - Simmaron Research Foundation is analyzing the effectiveness of treatments done at Dr. Peterson’s practice to generate enough pilot data to publish and get grants for larger studies. Their first data analysis includes Cidofovir, Ampligen and IVIG effectiveness. Documenting the success of these treatments and making them available for the right types of patients would be huge not just for them, but for how the disease is perceived.
Methylation Got You Down? – Crowdfunding efforts - are underway for a full-placebo-controlled clinical trial to study B12 and Folate supplementation in patients with and without a MTHFR B12 and Folate have been shown to reduce fatigue and cognitive symptoms in 20-50% of neuro-immune disease patients.
Immunotherapy to Target Natural Killer Cells – Is a fix for the natural killer cell problems endemic in ME/CFS in our future? Dr. Klimas’ Neuro-Immune Institute at Nova Southeastern University is confident that immunotherapy targeted at the IL-15 cytokine and NK cells will ultimately qualify for clinical trials.
HealClick Continues to Improve Matching Data – Given enough funding HealClick improves its matching data algorythms allowing people with ME/CFS, FM and other disorder find their ‘match’ and hopefully uncover treatments that work for them.
Mystery Drug Combo That Might Help ME/CFS Has Been Found. We Await Announcement – the CAA’s Biovista project suggested that a drug combination never tried before in ME/CFS just might work. They’re keeping mum on what’s in that combo so far, but sometime this year we expect some news.
Drug/Supplement Trial Underway to Increase Energy and Improve Cognition – A really intriguing trial combines traditional and alternative practices to see if low dose Ritalin in combination with a vitamin, antioxidant, amino acid, and therapeutic dosages of key nutrients that support brain and mitochondrial functioning adds up to increased cognition and energy.
Antioxidant Trial to Improve Brain Functioning Finishes Up - Dr. Shungu’s studies suggest levels of glutathione, the main antioxidant in the body, are greatly reduced (36% less than normal) in the brains of people with chronic fatigue syndrome. In this study he gives N-acetylcysteine (NAC) (2000 mgs) for four weeks to ME/CFS patients and then uses magnetic resonance spectroscopy to determine if their brain GSH levels normalize. He does blood testing to see if their oxidative stress levels go down, and administers questionnaires to see if their symptoms get better.
Uber Anti-Herpesvirus Drug (CMX001) Moves Closer to Approval – This uber herpesvirus (and other virus) drug employing a new mechanism designed to shoot it deep into the body to fight infections is undergoing Phase III trials. A Cfidovir analogue, this drug could be big news for ME/CFS patients with herpesvirus infection who are able to afford and get to it once it gets approved. The drug company that produces it just went public.
Hepatitis Drugs That Might Help Come on the Market - Dr. Chia has been waiting for these drugs for a while and now here they are. Dr. Chia believes three new Hepatitis C antiviral drugs coming on the market during 2014 could help with enteroviral infections in ME/CFS. One is very, very (very) expensive. No word on the other two. Dr. Chia will present two talks at the IACFS/ME conference.
Spinal Fluid Study Attempts to Uncover Cause of Neurological Dysfunction Part I – Spinal fluid is hard to get, but Dr. Peterson’s been collecting it for years and he sent it all the way to Australia give Dr. Sonya Marshall-Gradisnuk’s lab a crack at it. As a complement to the Lipkin study (see below) seeking to identify pathogens in spinal fluid, this study assessed the role of miRNAs and immune abnormalities in CFS patients compared to controls. These groundbreaking dual investigations seek to explain the neurological symptoms found in ME/CFS. It will be completed in early 2014.
Spinal Fluid Study Attempts to Uncover Cause of Neurological Dysfunction Part II – This Lipkin study used samples from the Simmaron Research Foundation to detect pathogens and pathogenic mechanisms in The Center for Infection and Immunity at Columbia University. Lipkin found ‘pathogenic abnormalities'; we’ll see what they were soon. Results should be published in early 2014.
Brain Study Seeks to Identify Neurological Subset in Chronic Fatigue Syndrome – This fascinating study determines whether ME/CFS patients without mood disorders have more, that’s right, more problems in the brain than ME/CFS patients with mood disorders. Dr. Natelson will use cognitive tests, spinal fluid tests, MRIs, blood flow tests, and lactate level tests. A positive result would set the stage for the recognition of a distinct neurological subset of people with ME/CFS who do not have a mood disorder.
EEG Findings Uncover Problems in the Deep Brain – EEG readings made by a Stanford team suggest problems are present in deep brain areas such as the thalamus, hypothalamus, cerebellum, and other organs that make up the brainstem. These areas specialize in producing fast unconscious reactions. This could be huge, but the Stanford team is also using more advanced brain analyses such as advanced LORETA methods, SnPM, and other new analytic techniques. Expect to hear more about these in the future
DNA Virus Reactivation Provides Hope for Treatments - last year the WPI found that dendritic cells may be reactivating ancient viruses embedded in ME/CFS patients’ DNA. More detailed work on this viral reactivation continues. Treatments that are being developed to fight a similar kind of viral reactivation in MS could provide help someday.
“Antibody Barcode” for ME/CFS Being Developed- Stephen Elledge of Harvard Medical School is developing an “antibody barcode” in this CFIDS Association Biobank study which will reveal all the viruses a person has been infected with over time. This 180 person study is underway now and will be complete late this year or early next year.
Next Generation Sequencing Reveals Viruses Present in Blood Plasma - this CFIDS Association study found no novel or highly divergent viruses in people with ME/CFS, but it did pick up viruses from 19 different virus families. The presence of viruses in the blood could indicate an active infection. Further research using healthy controls is needed
Cerebrospinal Fluid Pathogen Study Uncovers Role of Pathogens in ME/CFS Patients with Lymphoma – This Simmaron Research Foundation study parallels the Columbia University investigation of the cerebrospinal fluid of a subset of ME/CFS patients who went on to develop lymphoma or other cancers. Results should be published early 2014.
Post-Infectious Cardiomyopathy Study Focuses on the Heart - This Simmaron Research Foundation study investigates four subjects from Northern Nevada who developed a form of dilated cardiomyopathy with an unknown cause.
Neuroendocrine and Immune
Ambitious Extended Good Day/Bad Day Study Seeks to Develop Custom Gene Expression Panel for Diagnosis – In this expanded version of the ‘Good Day/Bad Day’ study which found that people with ME/CFS displayed distinct immune abnormalities during their ‘bad’ days, the NSU Klimas/Broderick/Fletcher group attempts to get at the immune, endocrine, and nervous system causes of those immune abnormalities. They plan to develop a custom gene expression panel that easily distinguishes ME/CFS from other diseases. That panel would end the worries about the inaccuracy of symptom-based definitions, identify key biological aspects of ME/CFS for future research, and perhaps even provide targets for drug therapies.
Epigenetics Study Reveals Immune Changes – Infections, trauma, and environmental stressors can all alter the expression of genes in our body. CFIDS Association of America researcher Patrick McGowan has found three immune genes whose expression has been altered by some past event in patients with ME/CFS. The results are being prepared for publication.
Lasker Prize Winner May Have Found Biomarker for ME/CFS - Michael Houghton has identified a possible biomarker for ME/CFS. In this 179 person CFIDS Association BioBank study, he’ll determine if he was right. The study is proceeding now.
NCNED Biomarker Study Down Under - Not so fast Micheal Houghton, Dr. Sonya Marshall-Gradisnuk’s team thinks they may have identified an immune biomarker as well. This study began last year.
Big WPI Study Hunts for Immune Biomarker – NIH funding ends in 2014 for this large study which attempts to confirm a gene expression biomarker, defects in the immune interferon system, HLA gene abnormalities, and more are present. The study will provide information necessary to identify subsets and hopefully elucidate treatment approaches.
Mast Cell Mouse Study Seeks to Validate Mast Cell Induced Brain Changes and Fatigue – Dr. Theoharides believes that stress activates mast cells causing them to pour out pro-inflammatory molecules which then cause ME/CFS. This very long mouse study puts mice into a fatigued state and then examines the blood brain barrier, brain expression of all sorts of immune markers, and then determines if a flavinoid formulation can increase endurance and reverse the brain anomalies.
“Leaky Gut” Whacks ME/CFS Patients? – Dr. Fletcher determines if microbial translocation from the gut (leaky gut) can help explain the ‘bad days’ ME/CFS patients experience, and will relate microbial translocation to immune, autonomic, and neuroendocrine markers.
Bad Gut Bacteria Causes Changes in Gene Expression in ME/CFS – Rebecca Hansen will determine if bacteria in the gut and the blood are different in people with ME/CFS, if gene expression in their gut cells is different, and if lactoferrin in fecal samples indicates an inflammatory state is present in the gut.
My guess is that exercise studies will get at the heart of ME/CFS quicker than any other type of study, and several big ones are underway or finishing up this year.
Exercise Throws Rapid Stress Response System Out of Whack – Dr. Fletcher of the Univ. of Miami uses gene expression, proteomics, and clinical data to show that the rapid response to exercise stress is, er… a bit compromised in ME/CFS.
System Breakdown After Exercise Identified – Proposing that ME/CFS results from breakdowns in how the major regulatory systems in the body interact, the Broderick/Klimas team ‘stimulated’ the stress response (neuroendocrine/immune systems) by whacking ME/CFS patients with exercise and then used molecular profiling (gene expression?) to determine how those systems fell apart. They then created an integrated model or map they’ll run simulations on to predict which therapies could return that system to normal. An ambitious project indeed.
We have heard that this study shows that the autonomic nervous system falls apart first during exercise and then triggers an immune cascade that causes the symptoms in ME/CFS. Hopefully we’ll hear more about that this year.
Big Mt Sinai CFS Research Center Exercise Study – the Center continues with its massive multidimensional ME/CFS exercise study.
Exercise Results in Metabolic Breakdown In ME/CFS – Rebecca Hansen of Ithaca University throws her hat into the ring with a study showing that the two day repeat exercise tests show a profound reduction in the ability to produce energy in chronic fatigue syndrome patients after exercise. Exercise physiologists shudder, throw their hands up in the air and exclaim that SOMETHING must be wrong with that machine.
Figuring Out Fatigue I – In an extension of the Light’s exciting older study showing that exercise produced rapid increases in fatigue and sympathetic nervous system and immune sensing receptors (remember the bar charts?) lasting at least 48 hours in ME/CFS patients but not in healthy controls, this study will use full genomic arrays this time (as well as targeted ones) and add genes such as neuropeptide Y (documented abnormality in ME/CFS), HPA axis receptors and more. They’ll attempt to produce a gene expression biomarker and add cancer-related fatigue and major depressive disorder to the list of disorders ME/CFS differs from (this study has been published), and determine subsets inside ME/CFS.
Figuring Out Fatigue II – The Lights have said they want to do for fatigue what has been done for pain. In this large study they’re uncovering how fatigue occurs at the molecular level. Thus far their studies suggest the molecular receptors that detect muscle metabolite are much, much more active in ME/CFS than normal. The study will use PCR, calcium imaging, immunohistochemistry, metabolite activated currents and more to nail down how fatigue signals in the muscles are produced and then relayed to the brain. The implications for the disease for which the term ‘post-exertional malaise’ was coined are obvious. They believe the study will lead to ‘rational, targeted therapies’ for severely fatiguing conditions.
Going Where Man Has Never Gone Before - The OMI’s big gene study using the latest technology (developed, no doubt, in Ron Davis’s own lab) peers, for the first time, into the most complex part of our genome which feature the immune system (HLA genes). Will this first look into HLA genes crack ME/CFS? Ron Davis thinks it could and we’ll find out fairly soon.This study moved fast; it was begun last year and is due to finish up early this year.
The Everything Study – Finally someone is doing the ‘everything’ study. In the ‘everything’ study the OMI throws just about everything at 20 ME/CFS patients in an attempt to get the whole ME/CFS picture. This study could tell us much about what’s gone wrong and how. These patients will get:
The Chronic Fatigue Initiatives two big (big) epidemiology projects are finishing up.
- A 1,000 patient study using patients from ME/CFS experts will establish what ME/CFS really looks like symptom-wise, what other types of disorders it usually appears with, how it proceeds over time and how effective ‘interventions’ (treatments) are. This study will dig deeper into what ME/CFS looks like, how serious it is, how difficult it is to treat, etc. than any before it.
- A Harvard study will take advantage of a huge public health data base to see in whom the disease appears, how it proceeds and what kind of environmental exposures (including infection) might set it off.