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.

“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.

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

“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.

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

"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.

Fibromyalgia Blood Test Gets Insurance Coverage

By Pat Anson, Editor

The founder of a bioresearch company that offers a controversial blood test for fibromyalgia says the test is now covered by Medicare and some private insurers. But questions remain about the viability of the test.  

“Insurance has really been the big issue for us. That was the hump we really needed to get over,” said Bruce Gillis, MD, the founder and CEO of EpicGenetics in Santa Monica, CA.

“We are a Medicare approved laboratory. It covers 100% of the test. We are getting private insurance companies that are reimbursing for the test. And we have gotten most Blue Cross Blue Shield agencies to pay for the test.”

“We are a Medicare approved laboratory. It covers 100% of the test. We are getting private insurance companies that are reimbursing for the test. And we have gotten most Blue Cross Blue Shield agencies to pay for the test.”

EpicGenetics introduced the FM/a test in 2013, calling it the first definitive blood test for fibromyalgia, a poorly understood disorder that is characterized by deep tissue pain, fatigue, depression and insomnia. The test costs $775 and results are usually available in about a week.

Gillis told Pain News Network that with insurance coverage now available he expects more people to take the test. He projects his lab to analyze its 5,000th FM/a test by the end of the year.

IMAGE COURTESY OF EPICGENETICS

The 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 than healthy people, according to Gillis, and have weaker immune systems as a result.

But critics have contended that the same immune system biomarkers can be found in people with other illnesses, such as rheumatoid arthritis, making the FM/a test meaningless.

Two small studies supporting Gillis’ theory have been conducted, both of them financed by EpicGenetics. The most recent study, published in Rheumatology International, compared the blood profiles of 160 patients who had taken the FM/a test to blood from hundreds of lupus and rheumatoid arthritis patients, as well as a control group.

“We were able to demonstrate statistically significant differences in scores comparing patients with FM (fibromyalgia), healthy controls and autoimmune disease,” wrote lead author Daniel Wallace, MD, a rheumatologist at the Cedars-Sinai Medical Center in Los Angeles and a professor at the David Geffen School of Medicine at UCLA who has worked as a consultant for EpicGenetics.

“This cytokine profile test had a 93% sensitivity and an 89.4% specificity for the diagnosis of FM. We also found that these profiles are relatively sensitive and specific for FM compared to SLE (lupus) and RA (rheumatoid arthritis). It remains unclear if these differences are directly related to the pathogenesis of FM.”

Wallace called his research “exploratory” and said further studies are needed to see if other autoimmune diseases can lower levels of chemokines and cytokines in the blood.

But Gillis goes further – saying the study “proved” that the FM/a test works.

“This study analyzed patients with fibromyalgia against patients with rheumatoid arthritis and lupus, the two primary illnesses in rheumatology. And it proved that our biomarkers are indeed distinct for fibromyalgia,” said Gillis.

"Junk Science"

But critics say more proof is needed – not only that the FM/a test works – but that fibromyalgia is a separate and distinct disease.

“The study is interesting but interpretation of their results is still made somewhat difficult by the fact that, as far as we know, fibromyalgia is not a discrete medical condition,” said John Quintner, MD, a rheumatologist in Australia. 

Quintner calls fibromyalgia a “symptom cluster” and says lower levels of chemokines and cytokines could be caused by a number of different disorders that trigger an immune system response. 

“Such conditions might also include major depressive disorder and post-traumatic stress disorder,” Quintner wrote in an email to Pain News Network.

An even bigger skeptic is Fred Wolfe, MD, a prominent researcher and rheumatologist who has called the EpicGenetic studies “junk science.” 

“The (new) study is very, very bad, and does not meet minimal scientific standards. The test is not needed and could not possibly be valid,” said Wolfe, who also considers fibromyalgia more of a symptom than a disease.   

“What you need to do in a study like this is you need to have an unbiased population. And this is by no means an unbiased population. They picked the people. If you’re measuring stress, it’s very easy to pick the patients you want and get the results you want,” Wolfe told Pain News Network.

“Fibromyalgia is an illness that can be found in people with rheumatoid arthritis and lupus. It occurs in about 25% of people with rheumatoid arthritis. It’s sort of like separating anxiety from cancer. A lot of people with cancer have anxiety. And the idea that you could have a test that separates anxiety from cancer is absurd because these conditions can occur together and frequently do.”

Pfizer Funding

Gillis says Wolfe’s views about fibromyalgia may have been influenced by funding he received from Pfizer, a pharmaceutical company that makes Lyrica – an anti-seizure drug that was re-purposed by Pfizer to treat fibromyalgia. Lyrica is Pfizer’s top selling drug with annual worldwide sales of over $5 billion.

According to ProPublica, Wolfe received $200,000 in funding from Pfizer from 2010 to 2013 for research and consulting.

“Our test says that fibromyalgia is an immunologic disorder,” said Gillis. “Why would you take an anti-seizure medicine for an immunologic disorder? Lyrica’s primary indication is for anti-seizure therapy.”

Wolfe says the funding he received from Pfizer was for a rheumatoid arthritis study, not fibromyalgia. As for Lyrica, Wolfe says he doesn’t consider the drug a good treatment for fibromyalgia.  

“I think what Pfizer has done has been very harmful, and I have stated and written this publicly. I was barred from speaking at a meeting some years ago by Pfizer and have continuously refused to cooperate with them,” he said.