Men Needed for Fibromyalgia Vaccine Study

By Pat Anson, PNN Editor

The start of a potentially groundbreaking study of a vaccine to treat fibromyalgia has been delayed because not enough men have volunteered to participate.

Massachusetts General Hospital and EpicGenetics – a Los Angeles-based  biomedical company  – received FDA approval last year to enroll 300 fibromyalgia patients in a placebo controlled Phase 2 study to see if the bacillus Calmette-Guérin (BCG) vaccine can be an effective treatment for fibromyalgia. Volunteers must first test positive for fibromyalgia after taking a diagnostic blood test developed by EpicGenetics.  

Half the volunteers will receive injections of the BCG vaccine every 12 months, while the other half will receive placebo injections. The 3-year study was initially projected to begin January first, but has yet to get underway.

“One of the problems we’re having is that the vast majority of the people who have taken the blood test are women aged 50 and above,” said Bruce Gillis, MD, the CEO and founder of EpicGenetics. “We really need more diversity. So we are pushing hard to find more men and more younger people to test.

“We’re still hoping to start this year. But we’re hoping for more diversity in the patients.”

Fibromyalgia is a poorly understood disorder that causes widespread body pain, fatigue, insomnia, headaches and mood swings. The cause is unknown, there is no cure and the symptoms are difficult to manage. Between 75 and 90 percent of the people who have fibromyalgia are women.

The BCG vaccine has been used for over 80 years to prevent tuberculosis and meningitis in children. Gillis believes the same vaccine can be used in adults to stimulate the immune system and reverse symptoms of fibromyalgia.

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“When BCG has been administered in other chronic illnesses, it has triggered the immune system’s stem cells to change their behavior. And in our case, we believe that should allow for the production of healthier peripheral blood mono-nuclear cells -- the white blood cells that we find to be impacted in fibromyalgia,” Gillis told PNN.

“The expectation is that when the patient receives the BCG there is a stimulus to change stem cells and white blood cell production to produce healthier cells.  And as a consequence, their fibromyalgia should be reversible.”

EpicGenetics’ FM/a blood test for fibromyalgia was first introduced in 2012 and is now covered by Medicare and most insurance companies. The cash cost for patients without insurance is $1,080. If the BCG vaccine proves effective, Gillis says the vaccine will be provided at no cost to patients who test positive for fibromyalgia.

Anyone interested in participating in the study at Massachusetts General Hospital should send an email to fmtest@epicgtx.com.

“We need patients from age 18 to 80 plus. And we need more men. I don’t think I’ll ever get an equivalent number of men as I will women, but I need more than just a handful of men,” says Gillis.

Breakthrough Blood Test Shows the ‘Color of Pain’

By Steve Weakley

A revolutionary new blood test developed by Australian researchers could give doctors instant insight into the severity of chronic pain by identifying colored biomarkers in the blood.  The “painHS” test uses advanced light spectrum analysis to identify the molecular structure of pain in immune cells.

“We are literally quantifying the color of pain,” explains neuroscientist Mark Hutchinson, PhD, a professor at the University of Adelaide Medical School in Australia.  “We’ve now discovered that we can use the natural color of biology to predict the severity of pain. What we’ve found is that persistent chronic pain has a different natural color in immune cells than in a situation where there isn’t persistent pain.”

Hutchinson and his colleagues discovered molecular changes in the immune cells of chronic pain patients. These pain biomarkers can be instantly identified through hyperspectral imaging, giving doctors the ability to measure a patient’s pain tolerance and sensitivity.

The test could potentially provide physicians with the first biology-based test to measure pain as the “5th vital sign” and to justify prescribing pain medication or other therapies.

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Hutchinson was quick to point out that the test is not intended replace a patient’s description of pain to their physician.  Pain is subjective and varies from patient to patient, depending on their medical condition and many other factors.  Current tests used to measure pain in adults, such as the sad and smiley faces of the Wong-Baker pain scale, are so simple they were initially developed for young children.

“Self-reporting (by patients) is still going to be key but what this does mean is that those ‘forgotten people’ who are unable to communicate their pain conditions such as babies or people with dementia can now have their condition diagnosed and treated,” said Hutchinson, who believes the test could also revolutionize pain treatment in animals.

“Animals can’t tell us if they’re in pain but here we have a Dr. Doolittle type test that enables us to ‘talk’ to the animals so we can find out if they are experiencing pain and then we can help them."

Hutchinson says the test could also help speed the development of new drugs that could target particular kinds of chronic pain, and could eliminate the need for placebos in clinical trials by giving an instant indicator of a treatment’s effectiveness.

“We now know there is a peripheral cell signal, so we could start designing new types of drugs for new types of cellular therapies that target the peripheral immune system to tackle central nervous system pain,” he explained.

Hutchinson thinks the “painHS” test could be widely available to pain specialists and general practitioners in as little as 18 months and could provide a cost-effective tool to measure the severity of pain in patients with back problems, cancer, fibromyalgia, migraines and other conditions.

Several other blood tests have already been developed to diagnose patients with specific chronic pain conditions such as fibromyalgia.

IQuity Labs recently introduced a blood test that can identify fibromyalgia by analyzing ribonucleic acid (RNA) in blood molecules. EpicGenetics launched the first fibromyalgia blood test in 2013. That test looks for chemokines and cytokines, which are protein molecules produced by white blood cells.

New Blood Test Launched for Fibromyalgia

By Pat Anson, Editor

A Tennessee laboratory has launched an innovative new blood test that uses RNA analysis to diagnose patients with fibromyalgia. IQuityLabs says its test – called IsolateFibromyalgia – can identify fibromyalgia within a week and with over 90 percent accuracy. The test costs $599.

Ribonucleic acid (RNA) is a molecule that plays an essential role in sensing and communicating responses to cellular signals. Unlike DNA tests, which can only predict the likelihood of someone having a disease, RNA tests show what is actually happening at a cellular level. 

IMAGE COURTESY OF IQUITY

IMAGE COURTESY OF IQUITY

“When we look at RNA in blood, we’re looking at a snapshot of what’s actually taking place at that moment inside the patient’s blood cells,” explained Chase Spurlock, CEO of IQuity. “Using that information, we can decipher those molecular communication patterns, those RNA signals that are taking place, and figure out does it look like fibromyalgia syndrome or does it look like something else?

“In the case of fibromyalgia, we completed our clinical validation studies and our accuracy is at 94 percent and the sensitivity and specificity are greater than 90 percent as well. So, it’s a highly actionable test.” 

The National Institutes of Health estimates that about 5 million Americans suffer from fibromyalgia, a poorly understood disorder characterized by deep tissue pain, fatigue, headaches, mood swings and insomnia. It often takes years for a patient to be diagnosed with fibromyalgia and some doctors still refuse to recognize it as a disease.

In 2013, California-based EpicGenetics launched the first fibromyalgia blood test. The FM/a test looks for chemokines and cytokines, which are protein molecules produced by white blood cells. Fibromyalgia patients have fewer chemokines and cytokines than healthy people, according to EpicGenetics, and have weaker immune systems as a result. Critics say the FM/a test is unreliable and the same molecule levels can be found in people with other disorders, such as rheumatoid arthritis.

Spurlock says RNA testing is more specific and accurate than DNA or other blood tests used to diagnose autoimmune conditions. 

“I think what this test will do is allow for clarity and efficiency in the provider-patient relationship,” he said. “Once we receive the blood samples here, our lab technicians process the sample and we report the result back within a week.” 

Last year IQuity launched blood tests to diagnose multiple sclerosis and irritable bowel syndrome (IBS). It hopes to further develop the science to diagnose other autoimmune disorders.

Study Shows Potential for Early Diagnosis of Arthritis

By Pat Anson, Editor

A new study by British researchers has demonstrated the potential for an experimental blood test that can diagnose arthritis in its earliest stages. Such a test could lead to earlier treatment of osteoarthritis (OA) and rheumatoid arthritis (RA), years before joint damage and physical symptoms begin.

Researchers at Warwick Medical School recruited 225 people with early or advanced OA, RA or another inflammatory joint disease, along with a control group of healthy volunteers with no joint problems.  Their blood and fluid from affected knee joints were then analyzed with mass spectrometry.

The test found patterns in blood plasma amino acids that were damaged by oxygen, nitrogen and sugar molecules. The damage was highest in the blood samples of patients with OA or RA, and markedly lower in the blood of healthy volunteers -- giving researchers identifiable biomarkers that could be used for an early diagnosis.

“This is a big step forward for early-stage detection of arthritis that will help start treatment early and prevent painful and debilitating disease,” said Naila Rabbani, PhD, of Warwick Medical School. “Damage to proteins in the arthritic joint have been known for many years but this is the first time it has been exploited for early-stage diagnosis.

“For the first time we measured small fragments from damaged proteins that leak from the joint into blood. The combination of changes in oxidised, nitrated and sugar-modified amino acids in blood enabled early stage detection and classification of arthritis – osteoarthritis, rheumatoid arthritis or other self-resolving inflammatory joint disease."

Dr. Naila Rabbani of Warwick Medical School

Dr. Naila Rabbani of Warwick Medical School

Rabbani says the blood test could be available to patients within two years. Her study is published online in Arthritis Research and Therapy.

Osteoarthritis is a progressive joint disorder caused by painful inflammation of soft tissue, which leads to thinning of cartilage and joint damage in the knees, hips, fingers and spine. The World Health Organization estimates that about 10% of men and 18% of women over age 60 have osteoarthritis. There currently is no diagnostic blood test for osteoarthritis.

Rheumatoid arthritis is a chronic autoimmune disease in which the body’s own defenses attack joint tissues, causing swelling, inflammation and bone erosion. About 1.5 million Americans and 1% of adults worldwide suffer from RA.

A blood test for RA is already on the market in the United States, Canada, Europe, Japan and Australia. The JOINTstat test looks for a protein that is usually found at high levels in the joints of people with RA.

Researchers Discover ‘Brain Signature’ for Fibromyalgia

By Pat Anson, Editor

Researchers at the University of Colorado Boulder have discovered a “brain signature” that identifies fibromyalgia with 93 percent accuracy, a potential breakthrough in the diagnosis and treatment of a chronic pain condition that five million Americans suffer from.

Fibromyalgia is a poorly understood disorder characterized by deep tissue pain, headaches, fatigue, anxiety, depression and insomnia. The cause of fibromyalgia is unknown and there is no universally accepted way to diagnose or treat it.

The CU Boulder researchers used MRI scans to study brain activity in a group of 37 fibromyalgia patients and 35 control patients, who were exposed to a series of painful and non-painful sensations.

The researchers were able to identify three neurological patterns in the brain that correlated with the pain hypersensitivity typically experienced with fibromyalgia.

UNIVERSITY OF COLORADO BOULDER

UNIVERSITY OF COLORADO BOULDER

"The potential for brain measures like the ones we developed here is that they can tell us something about the particular brain abnormalities that drive an individual's suffering. That can help us both recognize fibromyalgia for what it is - a disorder of the central nervous system - and treat it more effectively," said Tor Wager, director of CU Boulder’s Cognitive and Affective Control Laboratory.

If replicated in future studies, the findings could lead to a new method to diagnosis fibromyalgia with MRI brain scans. Patients who suffer from fibromyalgia have long complained that they are not taken seriously and have to visit multiple doctors to get a diagnosis.

"The novelty of this study is that it provides potential neuroimaging-based tools that can be used with new patients to inform about the degree of certain neural pathology underlying their pain symptoms," said Marina López-Solà, a post-doctoral researcher at CU Boulder and lead author of a study published in the journal Pain. "This is a helpful first step that builds off of other important previous work and is a natural step in the evolution of our understanding of fibromyalgia as a brain disorder."

One patient advocate calls the use of MRI brain scans a breakthrough in fibromyalgia research.

"New cutting-edge neurological imaging used by CU Boulder researchers advances fibromyalgia research by light years," said Jan Chambers, founder of the National Fibromyalgia & Chronic Pain Association. "It allows scientists to see in real time what is happening in the brains of people with fibromyalgia. 

"In fibromyalgia, the misfiring and irregular engagement of different parts of the brain to process normal sensory stimuli like light, sound, pressure, temperature and odor, results in pain, flu-like sensations or other symptoms.  Research also shows that irregular activity in the peripheral nervous system may be ramping up the central nervous system (brain and spinal cord).  So the effect is like a loop of maladjustment going back and forth while the brain is trying to find a balance.  This extra brain work can be exhausting." 

The theory that fibromyalgia is a neurological disorder in the brain is not accepted by all. Other experts contend it is an autoimmune disorder or even a “symptom cluster” caused by multiple chronic pain conditions. And some doctors still refuse to accept fibromyalgia as a disease.

One company has already developed a diagnostic test for fibromyalgia – and it’s not a brain scan. EpicGenetics has a blood test that looks for protein molecules produced by white blood cells. Fibromyalgia patients have fewer of these molecules than healthy people and have weaker immune systems, according to the founder of EpicGenetics. But critics have called the blood test “junk science” that is backed up by little research.

New Blood Test Predicts Early Rheumatoid Arthritis Risk

By Pat Anson, Editor

British researchers are developing a new blood test that could predict the likelihood of developing rheumatoid arthritis (RA) up to 16 years before the onset of symptoms. Such a test would substantially increase the early detection of RA and make treatment more effective.

Rheumatoid arthritis is a chronic autoimmune disease in which the body’s own defenses attack joint tissues, causing pain, inflammation and bone erosion.

Researchers at the Kennedy Institute of Rheumatology at Oxford University developed a blood test that looks for antibodies in a protein called citrullinated tenascin-C (cTNC), which is often found in high levels in the joints of people with RA.  

In a study of over 2,000 patients, the blood test diagnosed RA in about 50% of cases. The test also had a very low rate of false positives.

"What is particularly exciting is that when we looked at samples taken from people before their arthritis began, we could see these antibodies to cTNC up to 16 years before the disease occurred – on average the antibodies could be found seven years before the disease appeared,” said Professor Kim Midwood of the Kennedy Institute.

"This discovery therefore gives us an additional test that can be used to increase the accuracy of the CCP assay and that can predict rheumatoid arthritis, enabling us to monitor people and spot the disease early. This early detection is key because early treatment is more effective."

Early RA treatment focuses on suppressing the immune system to reduce inflammation and slow progression of the disease.

"Early diagnosis is key, with research showing that there's often a narrow window of opportunity following the onset of symptoms for effective diagnosis and control of disease through treatment. Furthermore, current tests for rheumatoid arthritis are limited in their ability to diagnose disease in different patients,” said Stephen Simpson, director of research at Arthritis Research UK, which funded the study.

"This could have great potential to help patients with rheumatoid arthritis get the right treatment early to keep this painful and debilitating condition under control."

A similar diagnostic blood test for RA is already on the market in the United States, Canada, Europe, Japan and Australia. The JOINTstat test looks for another protein called 14-3-3η. A recent study of 149 RA patients in Japan found that serum 14-3-3η levels can predict disease severity and clinical outcomes. Drugs that reduce 14--3-3η levels can delay the onset and severity of RA, and increase the chances of remission.

About 1.5 million Americans and 1% of adults worldwide suffer from RA.

UK Research Could Lead to Blood Test for Fibromyalgia

By Pat Anson, Editor

British researchers have launched a genetic study of fibromyalgia patients that they hope could lead to a new blood test to diagnose the disease.

Fibromyalgia is a poorly understood disorder characterized by deep tissue pain, fatigue, headaches, depression and insomnia. It is notoriously difficult to diagnose and treat, and some doctors refuse to recognize it as a disease.

Scientists at King’s College London will study tissue samples and measurements taken from volunteers enrolled in Twins UK, a comprehensive study on the effects of genes, aging, disease and the environment on over 12,000 identical and non-identical twins.

Four hundreds twins are enrolled in the fibromyalgia study. In each set of twins, one twin suffers from chronic widespread pain, while the other does not. Tissue samples from both twins will be compared to try to identify biomarkers in their DNA associated with chronic pain.

"Our research will help patients in two ways. First it'll contribute to our understanding of how fibromyalgia – and other chronic pain syndromes such as irritable bowel syndrome – develop, and point to pain pathways which we may not have suspected,” said lead researcher Dr. Frances Williams.

"Secondly, we hope it'll lead to identification of a biomarker which we could work into a blood test."

Fibromyalgia is believed to have genetic influences, but researchers say there are many complicated steps between the genes that may contribute to fibromyalgia and the condition itself.

The study will focus on identifying markers in DNA that are associated with the “switching” on or off certain genes. DNA switching is important to health, as it prevents inappropriate processes from occurring in the body when they should not. Identifying those markers could then lead to a blood test.

“As well as enabling the condition to be diagnosed more effectively, it could help to ‘stratify’ patients into groups depending on disease severity, which will help in clinical trials of potential new treatments. It might even help us predict how the condition will progress,” said Williams.

A bioresearch company based in Santa Monica, California is already marketing a blood test that it claims is 99% accurate in diagnosing fibromyalgia.

EpicGenetics introduced the blood test in 2013, calling it the first definitive test for fibromyalgia.

The FM test looks for protein molecules in the blood called chemokines and cytokines, which are produced by white blood cells. Fibromyalgia patients have fewer chemokines and cytokines in their blood, according to the company, and have weaker immune systems than normal patients.

The blood test costs several hundred dollars and results are available in about a week. Critics have said the test is unreliable and the same molecules can be found in people with other disorders, such as rheumatoid arthritis.