Test Maker Expands Research to Identify Genetic Markers Unique to Fibromyalgia and Explore Direct Treatment Approaches

Test Maker Expands Research to Identify Genetic Markers Unique to Fibromyalgia and Explore Direct Treatment Approaches

By Staff

Today with the assistance of major medical universities including UCLA, Massachusetts General Hospital and University of Illinois Chicago, EpicGenetics, Inc. announced the commencement of a new research study in fibromyalgia.

National Pain Report previously covered EpicGenetics’ FM/a® Test for the diagnosis of fibromyalgia, now, the company has announced they are seeking to make progress in uncovering information about FM that may, ultimately, help to provide a pathway for direct, effective treatment of the medical condition.

The study being announced will seek to do two things:

  1. identify genetic mutations unique to FM in up to 250,000 patients confirmed to have the medical condition via a positive FM/a® Test; and, based on these findings,
  2. explore a vaccine that could effectively treat and change the biology of fibromyalgia.

Fibromyalgia, is a painful, neurological disorder that, according to some estimates, may affect 10 million+ Americans. Still, there is limited research in and understanding of this medical condition, and fibromyalgia is too often misdiagnosed. Further, with limited treatment options and significant misunderstanding around fibromyalgia, patients are often told that they do not have a legitimate medical condition.

Although the test is not free, the company’s website claims that, a “growing numbers of patients are getting 100% insurance coverage” for the cost of the test, and they provide assistance in finding out whether an individuals insurance will cover the cost. Furthermore, according to their press release, “EpicGenetics will offer whole exome genetic surveys to FM/a® test-positive patients in a search for fibromyalgia-specific gene markers and mutations, analogous to the BRCA1/BRCA2 model for breast cancer. EpicGenetics’ associated CAMPAIGN 250 seeks to accomplish these gene surveys in up to 250,000 FM/a® test-positive individuals. The fees for these genomic surveys will be paid by EpicGenetics.”

Additional information about the study announced today is in the press release below. More information can also be found at www.FMTest.com.  And, the peer-reviewed research that was foundational to the FM/a® Test’s availability and effective use in diagnosing FM. (see “Peer-reviewed Medical Publications” in the page footer).

Press Release:

EpicGenetics, with the Assistance of Leading Medical Centers, Expands Clinical Study of FM/a® Test to Diagnose Fibromyalgia, Identify Genetic Markers Unique to the Disorder and Explore Direct Treatment Approaches

– Provides Research Gift to the Faustman Immunobiology Lab at Massachusetts General Hospital/Harvard Medical School to Support Research on Fibromyalgia Treatments –

LOS ANGELES – April 19, 2017 – EpicGenetics, a privately held biomedical company dedicated to improving the diagnosis and treatment of fibromyalgia, today announced that it has engaged the University of California, Los Angeles (UCLA)* and the University of Illinois College of Medicine Chicago (UIC). Both university research centers will be sequencing the exomes of patients to improve the diagnosis of fibromyalgia through the application of the FM/a® Test and to allow EpicGenetics to detect fibromyalgia disease-specific gene markers. Additionally, Bruce Gillis, M.D., CEO of EpicGenetics, has made a research gift to the Immunobiology Laboratory at the Massachusetts General Hospital directed by Denise Faustman, M.D., Ph.D., to continue its robust clinical research regarding a direct treatment for fibromyalgia.

The FM/a® Test is an FDA-compliant blood test that diagnoses fibromyalgia by identifying the presence of specific white blood cell abnormalities that have been documented to exist in these patients. The FM/a® Test accurately and objectively diagnoses this chronic disorder that afflicts millions of men, women and children.

EpicGenetics will offer whole exome genetic surveys to FM/a® test-positive patients in a search for fibromyalgia-specific gene markers and mutations, analogous to the BRCA1/BRCA2 model for breast cancer. EpicGenetics’ associated CAMPAIGN 250 seeks to accomplish these gene surveys in up to 250,000 FM/a® test-positive individuals. The fees for these genomic surveys will be paid by EpicGenetics.

“There has been very little innovation over the past several decades to help patients better understand and manage their fibromyalgia,” said Frederick G. Behm, M.D., the Frances B. Geever Professor and head of pathology at the University of Illinois College of Medicine Chicago. “Patients with this disorder frequently experience pain and fatigue that prohibits them from being able to engage in their daily lives. These patients are seeking answers to basic questions about the cause and etiology of the disorder – and, as physicians, we are frustrated that our previously limited research in this field prevents us from being able to answer these questions.”

“Since becoming available in 2012, the FM/a® Test has successfully and objectively diagnosed patients with fibromyalgia in the U.S. and multiple other countries, thereby providing these patients with a definitive diagnosis and certainty about a medical condition that has often been misunderstood and erroneously denied as a legitimate medical disorder,” said Bruce Gillis, M.D., CEO of EpicGenetics. “I believe we are at the forefront of advancing scientific information about fibromyalgia and answering these critical questions for patients: 1) Do I have fibromyalgia? 2) How and why did I develop fibromyalgia? and 3) Is there a direct treatment for fibromyalgia?”

Denise Faustman, M.D., Ph.D., director of the Immunobiology Laboratory at the Massachusetts General Hospital and a noted immunologist at the Harvard Medical School, will initiate plans for a clinical trial at the Massachusetts General Hospital to test the potential of the Bacillus Calmette-Guérin (BCG) vaccine to change the biology of fibromyalgia.

FM/a® test-positive patients will be offered an opportunity to participate in this vaccine trial once the study protocols have received the required institutional and regulatory approvals.

As Dr. Faustman explains, “The Massachusetts General Hospital is announcing a new research effort on the application of the BCG vaccine, which will be directed at changing the biology of fibromyalgia as it concerns the foundational immune system discovery of the role particular cytokines have in fibromyalgia.”

The FM/a® Test will consequently not only serve to objectively confirm the diagnosis of fibromyalgia, but also act as the gateway for fibromyalgia patients through these newly announced research efforts to participate in genetic studies to further define their disease.

The cost of the FM/a® Test is covered by most insurance companies and Medicare.

Once diagnosed by the FM/a® Test, EpicGenetics will cover patients’ direct laboratory costs for the genetic surveys and for further research on their disease. Patients who are suspected of having fibromyalgia need a licensed health care practitioner to authorize their FM/a® Test.

To learn more about the FM/a® Test and these clinical studies, including details on participation, please visit www.FMTest.com or http://www.facebook.com/TheFMTest.

About Fibromyalgia 

Fibromyalgia is a chronic disorder marked by a variety of symptoms that can include chronic diffuse pain, fatigue, sleep disturbances, muscle tenderness, headaches and depression, as well as problems with thinking and memory function. This disorder is known to impact an estimated 6 percent of the population,[i] and it isn’t age, gender or ethnic specific. However, due to a previous lack of diagnostic tools and a common denial of the legitimate existence of fibromyalgia, many believe that this number may in fact be much larger.[ii]

Current treatment options for fibromyalgia are limited, offer only indirect and symptom-limited approaches, and primarily include anticonvulsants, opioids and antidepressants which help only some patients manage the disorder’s symptoms, though they do not treat the cause. Further, several of these treatments carry “Black Box Warnings” regarding their potentially dangerous side effects.

About The FM/a® Test 

The FM/a® Test is the first FDA-compliant, objective blood test to diagnose fibromyalgia. It is a multi-biomarker-based test that analyzes immune system white blood cell production of critical chemokine and cytokine/protein patterns. These proteins demonstrate an abnormal pattern in fibromyalgia patients which the FM/a® Test can identify so it will correctly and objectively diagnose this medical illness. Results of the FM/a® Test are based upon a 1-100 scoring system, with fibromyalgia patients having scores higher than 50. The test has been clinically validated to diagnose fibromyalgia with a 93 percent sensitivity.

The FM/a® Test is a result of research and clinical studies that were performed at the University of Illinois College of Medicine Chicago. It has been recognized by the American Association for Clinical Chemistry (AACC) for “Outstanding Research in Clinical and Diagnostic Immunology.” Peer-reviewed published medical studies have served as the basis of the FM/a® Test, based upon the testing of hundreds of patients.

The FM/a® Test is a Laboratory-Developed Test (LDT) that was developed — and is performed — in a CLIA certified and CAP accredited laboratory. The test fulfills the FDA regulation (21CFR 866.5700) for an immunological test system.

About EpicGenetics

EpicGenetics, Inc. is a privately held biomedical company based in Los Angeles, California, that developed and manufactures the FM/a® Test. EpicGenetics is dedicated to improving the diagnosis and treatment of fibromyalgia by offering the first conclusive diagnostic test for fibromyalgia, and by investing in and developing further comprehensive clinical studies at leading medical research centers. More information is available at www.FMTest.com.

# # #

*UCLA has been engaged to sequence the exomes of research subjects. [i] About Fibromyalgia: Prevalence. National Fibromyalgia & Chronic Pain Association. http://www.fmcpaware.org/fibromyalgia/prevalence.html.

[ii] Arnold LM, Clauw DJ, McCarberg BH, and FibroCollaborative. Improving the recognition and diagnosis of fibromyalgia. Mayo Clin Proc. 2011;86(5):457-464.

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The usual suspects push their medical agendas here but what have you done for me today? I spent a lot of my own money to to get this test and hopefully get the vaccine down the road. That’s how medicine and patient care advance, with research and clinical trials, not the same old personal agendas and words.

John Quintner

@ The Sinister Porpoise:

The findings you mention would be more meaningful if a third comparator group had been included in the fMRI studies, that is, those experiencing chronic pain associated with discrete diagnosable conditions. This point has already been eloquently made by Professor Wolfe: http://www.fmperplex.com/2016/08/30/most-fibromyalgia-research-is-worthless/

I do not believe that I have misrepresented Professor Clauw’s argument. Of course he is quite at liberty to respond to my criticisms on this public forum, or on Fibromyalgia Perplex, if he so wishes.

As far as I am concerned, a diagnosis of fibromyalgia has never been a useful one, but the clinical phenomena are real enough and demanding of scientific explanation.

Cohen ML, Quintner JL. Fibromyalgia syndrome, a problem of tautology. Lancet 1993; 342: 906-909.
Quintner JL. Cohen ML. Fibromyalgia falls foul of a fallacy. Lancet 1999; 353: 1092-1094.

In my opinion (actually, to be found in a published hypothesis paper), they constitute a “symptom cluster” characteristic of persistent activation of systems of stress/sickness response. This paper also contains our views on treatment.

Reference: Lyon P, Cohen ML, Quintner JL. An evolutionary stress-response hypothesis for chronic widespread pain (Fibromyalgia Syndrome). Pain Medicine 2011; 12: 1167-1178.

The Sinister Porpoise

Clauw’s finding that fibromyalgia patients show a different response to pain than healthy controls has been repeated. As usual, however, when I heard about the news, it was slightly overblown in the news media that reported it. (You’d think after my own experiences of trying to report news about science I’d know not to trust most other reporters doing the same thing. Scientist’s aren’t trained to write; reporters aren’t trained to be academics.) But I believe you’re misrepresenting Clauw’s argument and confusing it with his anahlogy. It is a good analogy for what the brain might be doing, but if I understand what he and others have said, it’s a matter of the brain starting to respond to signals that it would normally ignore. Here’s quote from one of several studies I can find backing up Clauw’s findings: “Background: Nociceptive stimuli may evoke brain responses longer than the stimulus duration often partially detected by conventional neuroimaging. Fibromyalgia patients typically complain of severe pain from gentle stimuli. We aimed to characterize brain response to painful pressure in fibromyalgia patients by generating activation maps adjusted for the duration of brain responses. Methodology/Principal Findings: Twenty-seven women (mean age: 47.8 years) were assessed with fMRI. The sample included nine fibromyalgia patients and nine healthy subjects who received 4 kg/cm2 of pressure on the thumb. Nine additional control subjects received 6.8 kg/cm2 to match the patients for the severity of perceived pain. Independent Component Analysis characterized the temporal dynamics of the actual brain response to pressure. Statistical parametric maps were estimated using the obtained time courses. Brain response to pressure (18 seconds) consistently exceeded the stimulus application (9 seconds) in somatosensory regions in all groups. fMRI maps following such temporal dynamics showed a complete pain network response (sensory-motor cortices, operculo-insula, cingulate cortex, and basal ganglia) to 4 kg/cm2 of pressure in fibromyalgia patients. In healthy subjects, response to this low intensity pressure involved mainly somatosensory cortices. When matched for perceived pain (6.8 kg/cm2), control subjects showed also comprehensive activation of pain-related regions, but fibromyalgia patients showed significantly larger activation in the anterior insulabasal ganglia complex and the cingulate cortex. Conclusions/Significance: The results suggest that data-driven fMRI assessments may complement conventional neuroimaging for characterizing pain responses and that enhancement of brain activation in fibromyalgia patients may be particularly relevant in emotion-related regions.” Clauw’s study appeared a year before. Research with fMRIs seems to be backing up his conclusion that fibromyalgia patients have an abnormal response to pain. This seems to be present in other Chronic Pain states as well. *Pujol J, López-Sola M, Deus J, et al. Mapping Brain Response to Pain in Fibromyalgia Patients Using Temporal Analysis of fMRI. Plos ONE [serial online]. April 2009;4(4):1-10. Available from: Academic Search Premier, Ipswich, MA. Accessed May 3, 2017. I know some genes are related to making a person more likely to develop fibromyalgia. Is it likely that these genes can cause the body to become overly sensitive to stressful situations — physical or mental — and once… Read more »

The Sinister Porpoise

Dr. Quinner, I notice that you post to the FM perplex, a site that seems to be skeptical of fibromyalgia. Clauw is an active researcher, but saying that fibromyalgia is “better understood” than it ever was before isn’t saying much. I can, however, link to repeated studies that have confirmed Clauw’s findings with the fmri signatures. This is, as I’m sure you would admit, good science. While this does not, as far as I know, provide a useful diagnostic tool as of yet, it is a good start. I do not know where you stand on fibromyalgia. Wolfe seems to be a bit embarrassed by being one of the lead researchers for a disease that is, admittedly, currently poorly defined. For many people, it stands as a diagnosis necessary to get treatment for chronic pain problems until their doctors can figure out that something else is wrong. The problem there is that some doctors stop searching when they have an answer. When I was diagnosed with fibromyalgia, my doctor would not perform any other tests to rule anything out. Considering certain autoimmune diseases run in my family, I sought a second opinion. As it turned out, I *did* have sub-clinical Hashimoto’s Disease at the time, but it was my physical therapist who provided the first clue. She told me I have hypermobile ankles. It took some time, but another doctor told me I have Ehlers-Danlos Syndrome-Hypermobility Type. I’m not sure if she’s right, but even with not being very bendy I scored high enough on the Beighton Scale to qualify. (However, considering she is an expert and served on the board of the EDNF, I’ll defer to her opinion. As far as my rheumatologist thinks, it doesn’t matter. She’s doing the right thing to treat ligament laxity and that, rather than the underlying cause of it, is more important to me. Being condemned to a near lifetime of physical therapy wasn’t all that thrilling, but it’s far from the scary things I imagined when the whole thing started. Oddly, I sought out her opinion to rule it out.) From my own research on this topic, I’ve figured out that most of the doctors working on fibromyalgia are just *guessing.* I’ve held the theory that it’s a secondary condition that can be initiated by an external cause for a while, but my opinions carry no weight. From what I can tell, you and Wolfe have been attacking research and promoting psychological treatments. Doctors have long known that depression and pain are linked, but I really wish you would back off from the psychological suggestions and suggest other avenues of possibility rather than attacking current research. I wish more people would take my rheumatologist’s approach. Don’t worry about the cause as much as the treatment. In my experience, my rheumatologist is the most cautious of my doctors. At least my PCP is no longer baffled by me. As for you, Wolfe, and the contributors to the fibromyalgia perplex, your criticism seems to… Read more »

John Quintner

Thanks for your response.

I am pleased to hear that the researchers who came up with the test are seeking to replicate their results. But, as you rightly say, others will also need to replicate them before the test is likely to be generally accepted as being useful for diagnostic purposes.

As I mentioned above, a search for a third pain descriptor is currently on the agenda of the International Association for the Study of Pain. Professor Clauw and his supporters are plugging for it to be “centralized”. Their efforts are being supported financially by a prominent pharmaceutical company that markets drugs that have been approved by the NIH for the treatment of the condition.

In the context of chronic widespread pain, the term “centralized” refers to “central nervous system origins of or amplification of pain” [Clauw 2014]. Elsewhere in his JAMA article, Professor Clauw suggests that the term implies “peripheral nociceptive input might be responsible for some of a patient’s pain but central nervous system factors likely amplify the pain.”

Thus it appears that peripheral nociceptive input is not a necessary contributor to a patient’s ongoing pain. But should it happen to be the case, Professor Clauw [2014] proposes that the patient feels “more pain than would normally be expected based on the degree of nociceptive input.” But he fails to disclose how a clinician/observer is able to make such a determination with any degree of confidence! It sounds to me that a lot of inspired guesswork is involved.

When discussing amplification of pain, Professor Clauw uses the analogy of an electronic device, i.e. the amplifier. Apparently the levels of neurotransmitters that can either facilitate or reduce “pain transmission” determine where the dial is set for a particular patient.

Of course, the belief that pain is “transmitted” along “pain pathways” (as claimed by Professor Clauw) is both flawed and outdated. Nerves transmit electrical impulses rather than a “thing” called pain.

Furthermore, given that the brain creates the lived experience that we call “pain,” it seems impossible to conceive of a brain being able to amplify an experience for which it is primarily responsible.

Professor Clauw (2014) tells us that, “Fibromyalgia and other centralized pain states are much better understood now than ever before.”

But he gives the game away when he suggests that on the one hand fibromyalgia can be considered as a “discrete diagnosis” whilst on the other hand it can be considered as “a constellation of symptoms characterized by central nervous system pain amplification with concomitant fatigue, memory problems, and sleep and mood disturbances.” Based upon this reasoning, clinicians are permitted to choose either possibility.

Far from there being a “better understanding” of fibromyalgia, as claimed by Professor Clauw, it seems to me that an appreciable element of diagnostic confusion and circular reasoning still exists.

In my opinion it is therefore premature to conclude that this “constellation of symptoms” can be explained as a neurological disorder.

Reference: Clauw DJ. Fibromyalgia: a clinical review. JAMA 2014; 311(15): 1547-1555.

Brenda Stapleton

Hello ALL: I must say I applaud anyone taking Fibromyalgia out for a “research-related” spin! I will too, send in the paperwork and shoot for the moon, as all people with a chronic illness will spend their last dime to have any resemblance of their life back. Who knows, I may not have it. Maybe I have Lyme Disease, or perhaps MS? I hear you, Kathy! I have had Optic Neuritis, spots on my brain per MRI for the last six years, I have deficits on all my EMG’s including scar tissue, etc. I fit the profile of MS, but they have not collected spinal fluid, because every time I have a flare, my neurologist is out of town, or they can’t get me in. When I did come in, I got the third degree about how he can’t do it now. I now have my MRI’s checked for dye, and return again yearly. I have pressure points, so Rheumatology says, “It is Fibromyalgia. I’ve been on 60 of Cymbalta and 25 of Lyrica up to 60 of Cymbalta and 450 of Lyrica. I am back at 60 of Cymbalta and 25 of Lyrica. I have pain management take care of this now, and no longer treating with Rheumatology because he couldn’t understand why wanted to practice medicine instead of just listen to him. I too, have symptoms of so many things, and Fibro does fit the bill, but that seems to be the problem. No one knows enough about it to diagnose it or treat it. They need to go back to the drawing board with it. What is being defined by the medical community as Fibromyalgia evidenced by symptoms of unknown origin, has become categorized as neurological, gastrointestinal, etc. Does anyone know if fibro is neurological, rheumatological, immunological, gastrointestinal, etc. ? The answer Kathy, Fibro has symptoms of those things. There is research stating a build up of heavy metals and toxins can trigger it as well. People have had fillings from their teeth remove, and titanium hip replacements changed to ceramic to rid themselves of it. They still have it. I think the cause is damage or impairment to the central nervous system somewhere in the body that causes the nocipathic disruptions in the HPA characterized by the marked elevations of hormonal imbalances, inability to regulate body temperature, sleep cycles, bladder functions, digestion, etc. It seems like the only thing that makes sense. At this point, it would be worthwhile to spend $50 to get this test. I have spent so much more on “experts” in the field who know less about what is going on with it than I do. If people are looking for answers? I will support them. Maybe it’s 3-6 years down the road, but if Fibro is hereditary, I have two daughters that may need the benefit long after me. And for me, Nursing was my passion before Fibro took life away from me. If something they find from people like me,… Read more »

The SinisterPorpoise

John Quintner,

I don’t know if many people know that the reason people don’t accept this test isn’t over the science largely, it’s over the ethical failures of the original study. I’m glad to see they’re doing the research again, but I would love to see an independent researcher do the test and see if they come up with the same results.

I think the authors are concluding it’s a neurological disorder based off the works of Dr. Clauw and others who have found a neurological signature under FMRIs

John Quintner, Physician in Rheumatology and Pain Medicine

I suggest you ask the researchers to provide you with a protocol that has been passed by an ethics committee and made available (in plain language) to all potential participants in the study. Then you should be able to make an informed choice as to whether or not you wish to take part in their study.

I don’t really understand all the medical jargon written in these comments and it makes it hard for me to decide if this test is worth having done. I filled out the paper, and the research place did contact me and said, my medicare would pay for the test, but I’d still have a share of cost (for the test) of $50 out of pocket. $50 may not be much to some people, but when a person lives on only $900 a month (in the highest cost of living state in the country) then $ 50 is a lot of money. They also said, that it will be at “least” 3 to 6 years before any kind of vaccine or treatment would be tried out on those people with a positive diagnosis. I’ve lived with Fibromyasia for 16 years, actually longer than 16 years, because it took almost 3 years of living in pain before I was actually diagnosed with it. The research company also said, once treatments were to finally reach the try out stage(3 to 6 years) that I would probably have at least another $45 to 50 dollar out of pocket. I mean I don’t really need a diffident diagnosis of Fibro, I know that I have it, with 18 or 18 trigger points and all the other symptoms that go along with it. As well as I have other medical issues. But to spend $50 now for something that “might” be developed in 3 to 6 years from now and then with all the comments here that I don’t really understand what is being said, I don’t know rather I should bother to get this test. Over the 16 years that I have lived with this pain of Fibro, I’ve been told by Dr.s that it is all in my head, that it is a nerve disease, that it is a neurological disease, that it is an over active disease of the immune system, that it is caused by little nodules of the same substance that bone is made of, that build up between the muscle fiber. I don’t know who to believe!!!…To me, I’ve always believed it is some kind of an undetectable virus (similar to the flue, or Epstein bar virus) that lives within my body. Recently I was told by a neuropathic Dr. that fibromyasia isn’t a disease in it’s self, it is a set of symptoms, being caused by an unbalanced body, that possible has a build up of heavy metals and toxins, ect. So I don’t know who to believe!!! I know for 4 years I was thought to have MS, because an MRI showed white blotches all in my brain, and then 2 different spinal taps, showed abnormalities in my spinal fluid. So they told me the “believed” I had MS, but then the 3rd spinal tap they did, showed a change in my spinal fluid. They said my spinal fluid was still abnormal, but yet it didn’t have something… Read more »


Mr Quintner is a rare bird in todays world of medicine as he has the integrity to do his own independent and critical thinking. I believe he is on target when he points to the ship of fools in fibromyalgia research. It is clear to me there is a lack of intelligence in fibro research and in pain research. There is a lack of courage and commitment to a much different and better future for people in pain. We need to remoralize and revolutionize pain research and discard inadequate methods pf the past and present.

John Quintner, Physician in Rheumatology and Pain Medicine

According to the Press Release: “The FM/a® Test will consequently not only serve to objectively confirm the diagnosis of fibromyalgia, but also act as the gateway for fibromyalgia patients through these newly announced research efforts to participate in genetic studies to further define their disease.”

This confident assertion raises the important question as to why the FM/a® Test has never been endorsed by the American College of Rheumatology nor by any other official professional rheumatological body or association.

Is it any wonder that the skepticism I originally expressed as to the usefulness of the test has not been dispelled?

Link: https://www.arthritiswa.org.au/news/view/fact-or-fiction-the-fm-test.html

John Gaspary

“There has been very little innovation over the past several decades to help patients better understand and manage their fibromyalgia,” said Frederick G. Behm, M.D., the Frances B. Geever Professor ..”
By contrast John Quintner, Milton Cohen and their confreres have shone a light on the vast amount of misinformation about fibromyalgia that has prospered in the past few decades. Their evolutionary perspective offers a completely new way of thinking about it. The casual reader in indeed lucky if they come across some of their work. Far from creating confusion they offer a way out of the mire of pseudo science and circular argument that plagues even peer reviewed journals.

John Quintner, Physician in Rheumatology and Pain Medicie

Robert, you do need to know that in my opinion your comments are both untrue and highly defamatory. In order to put the matter straight, you might like to carefully read the following article and withdraw your comment, perhaps with an apology(?). TITLE: Evolution, Stress and Fibromyalgia Adapted from: Lyon P, Cohen M, Quintner J. An evolutionary stress-response hypothesis for Chronic Widespread Pain (Fibromyalgia Syndrome). Pain Med 2011; 12: 1167-1178. Despite affecting huge numbers worldwide and being researched extensively over 25 years, fibromyalgia syndrome (FMS) remains a problematic construct, for clinicians and patients alike. Characterised by persistent widespread pain and tenderness disproportionate to demonstrable tissue damage, of which there may be none, the syndrome often includes sleep disturbance, fatigue, ‘irritable bowel,’ cognitive and affective changes, and, less frequently, skin disorders. Without a cogent model of pathogenesis for this complex syndrome, effective treatment remains elusive. An evolutionary approach provides insight. Several clinical features of FMS accord with “sickness behavior,” found widely in the animal kingdom, which is the observable manifestation of physiological processes working to restore proper functioning. Sickness behavior is part of the organism’s response to some sort of stressor (threat, disturbance), which may be perceived via innate immunity or cognitively. The building blocks of the human stress response (i.e., cytokines, neurotransmitters, hormones) are evolutionarily ancient. The systems that underlie the human stress response (SR) are multiple, co-modulatory and co-regulatory. Almost from the moment a SR is activated, countervailing processes also activate, to ensure that the dramatic molecular events marshaled to save the animal don’t damage the animal. This is because many molecular actors involved in SRs are ‘double-edged,’ and can have negative as well as positive effects on organism functioning. The response to stress thus is designed to engage, repair, and then stop (resolve). When an SR is prolonged in any organism, for whatever reason, profound changes occur in functioning and behaviour. Chronic SR activation in humans is associated with some of the most medically important diseases in the developed world, including cardiovascular disease, type 2 diabetes, and metabolic syndrome. One of the ‘double-edged’ molecules involved in vertebrate SRs and associated with a wide variety of chronic human diseases is substance p (SP), a deeply conserved neuropeptide also found in insects and molluscs. In humans, SP operates in both the central and peripheral nervous systems. With its preferred receptor neurokinin-l (NK1R), SP is involved in a staggering range of defensive mechanisms, including cytokine release, cell manufacture and migration to sites of injury, mast cell granulation, edema, vomiting, gut contraction, cell death, and aversive reinforcement learning. Its importance to human functioning is reflected in ontogeny: SP is one of the first neurotransmitters to appear in foetal development, before other SR actors, including corticotropin-releasing hormone, adrenaline, noradrenaline, dopamine, and serotonin. The relevance of SP for understanding FMS is three-fold: (i) elevated SP in cerebral spinal fluid is the most reliable biomarker of FMS. Patients typically have SP levels 2-3 times those of healthy controls. (ii) SP is highly correlated with the… Read more »

John Quintner

Is fibromyalgia really a “neurological disorder”?

As far as I am aware, no such consensus has ever been reached.

But there is currently a vigorous debate taking place over a third descriptor designed to accommodate the pain of those in whom there is no discernible evidence of either ongoing nociception or of neuropathy.

Here is a link that may be useful for those who are interesting in following this debate: http://www.fmperplex.com/2016/08/23/why-centralized-is-unacceptable-as-a-descriptor-for-the-pain-of-fibromyalgia/

P.S. SA far as I am aware, the above-mentioned test has not been endorsed by the American College of Rheumatology nor by any other official professional rheumatological body or association.


Bcg virus for fibro is interesting and a significant change from the neurocentric model of aberrant brain signaling. Nonetheless bcg wont be enough to restore normal functioning as fibro involves numerous pathways. I think the key is to assess malfunctions and address them accordingly as well as build overall wellbeing.