EpicGenetics – a biotech firm in Los Angeles – is attempting an FM trifecta: produce a blood and genomic test and provide a treatment.
A blood test, genomic signature, treatment…EpicGenetics is trying to redefine how FM is thought of and treated.
EpicGenetics is trying to make a big splash in fibromyalgia. A Los Angeles biotech firm, they focused on producing diagnostic tests for complex conditions and produced what they believe is a highly unusual trifecta for any disease: 1) development of the first blood test for FM; 2) development of a genomic diagnostic test and; 3) launch of a treatment trial.
They seem to be doing well. Buoyed by demand for their FM/a blood test, the Los Angeles firm recently quadrupled their footprint, moving their labs and offices into a 50,000 sq. ft, facility. It’s all coming to a head, though. Their blood test, genomic test and treatment effort are all of a piece and will likely all rise or fall together. With their treatment trial underway, we should know over the next year if EpicGenetics is the next big thing – more accurately, the first big thing in FM – or not.
2012
When I learned they’d developed what they believe is an immune blood test for fibromyalgia (FM) (?), I felt like rubbing my ears. Researchers had been focusing on the immune system in chronic fatigue syndrome (ME/CFS) for decades but have given it little attention in FM. I wasn’t dreaming, though. An immune test was being touted for FM – not ME/CFS. How had that happened?
The FM/a story starts back in 2012 with a University of Illinois study, “Unique immunologic patterns in fibromyalgia“. Immune cells from a huge set of FM patients and healthy controls (n=201) were cultured overnight and then stimulated the next morning with profoundly irritating plant lectins (PHA (phytohaemagglutinin) or PMA (pokeweed mitogen)).
(PHA is found in red and white kidney beans, green beans and fava beans. It takes just 5 raw red kidney beans to induce poisoning. Wikimedia reports that cooking reduces the very high levels of lectins in red kidney beans to safe levels. Some ME/CFS/FM practitioners do tout a lectin-free diet, however.)
These kinds of mitogenic tests are commonly used to assess white blood cell activity. The levels of 8 cytokines (IL-5, IL-6, IL-8, IFN-γ, IL-10, MIP-1α, MIP-1β, MCP-1) were measured before and after the stimulation.
No differences were found in the cytokine levels of FM patients or healthy controls before stimulation but, as in ME/CFS, adding a stressor got things moving – or rather, in the case of FM – failed to get things moving.
After the mitogenic stimulation, no less than seven of the 8 cytokines measured were quite significantly lower (1.4-8x’s lower) in the FM patients. For some reason, the FM patients’ immune cells had reacted in a lackadaisical manner to the powerful stimulant given them. (Later analyses revealed that the test worked fine using just 4 cytokines.)
The authors noted that a similar pattern of reduced immune response to stimulation occurs in Sjogren’s Syndrome and depression.
2015
The 2015 study by noted UCLA immunologist Daniel Wallace, “Cytokine and chemokine profiles in fibromyalgia, rheumatoid arthritis and systemic lupus erythematosus: a potentially useful tool in differential diagnosis“, was bigger (n=358) and, with its inclusion of rheumatoid arthritis (RA) and lupus patients, better. EpicGenetics was clearly hot on the trail of a diagnostic test.
Cytokine responses to stimulation were much reduced in FM patients compared to healthy controls.
The big question was whether people with autoimmune diseases like RA and lupus would have the same or a different cytokine profile as people with FM. By all rights, they should have been similar. FM, after all, got shoved in the rheumatology silo early on – which is packed with autoimmune diseases characterized by overactive immune responses.
Yet the results suggested FM was nothing like the other two autoimmune diseases. It demonstrated both high sensitivity (it picked out people with FM) and specificity (it rarely picked out people with RA, lupus or healthy controls). If you have FM, the test should show that. If you have RA, lupus or are healthy and don’t have FM, it’s unlikely you will test positive.
The increased cytokine production seen in RA and lupus suggested they’re not closely related to FM. (A subset of people with RA and lupus, and indeed, it seems all chronic pain diseases, do also have FM).
The authors noted that a similar pattern of reduced immune response occurs in Sjogren’s Syndrome and depression. The authors were careful to say that the findings do not necessarily mean that FM is caused by an immune dysfunction, but Gillis has stated that he believes the immune systems of FM patients are not producing enough protective cytokines.
Strange Findings
Some of the findings, though, seemed strange. IL-6 – an important cytokine known to induce pain and sympathetic nervous system activation – was reduced in FM instead of increased. So was IL-8 – another major pain player – which also plays a role in pathogen defense. Low levels of MIP alpha and beta seemed to make more sense – both play a role in natural killer (NK) cell defenses.
FM researcher Daniel Clauw stated that the results flew in the face of past FM results – and he’s right: while mitogen-activated IL-6 tests have not been done in FM, both IL-6 and IL-8 have been found elevated in FM.
A 2016 study reported that “IL-6 and IL-8 are two of the most constant inflammatory mediators in FM” and that their levels correlated with symptom severity. A 2013 study found that a marker of inflammation (c-reactive protein) was correlated with IL-6 and IL-8 levels in FM and a 2014 review specifically pegged increased IL-6 and IL-8 levels as significant factors in FM.
In 2013, Clauw wanted the study to be replicated and in 2015, he got a replication in a very large study. Now – perhaps the best thing to do is to try to make sense of these seemingly paradoxical findings.
EpicGenetics has asserted (as did VanElzakker for ME/CFS) that the short life of cytokines, the effects of circadian rhythms on them, and other issues made assessing cytokine levels in the blood “unreliable”. Far better, they said, to isolate immune cells, smack them with an immune trigger, and see how they respond. They could be right.
Plus, who knows – maybe the weird pattern in ME/CFS where the system seems to be on alert – but folds when presented with a stressor – is showing up in FM as well.
What is Fibromyalgia Anyway?
IF FM isn’t a “normal” rheumatological disease, what is it? The authors proposed FM is a central sensitization disorder characterized by reduced responses to all sorts of different kinds of stimulation (sympathetic, hormonal, cytokine and chemokine).
All one may need, they suggested, to differentiate central sensitization from autoimmune disorders is to whack their immune cells with a trigger and see how they respond: the immune cells from people with central sensitization disorders will respond poorly, while the immune cells from people with autoimmune disorders will leap into action.
If EpicGenetics is right, FM is the odd man out in the rheumatological field.
(Two years ago, Wallace found that another immune test – “cell-bound complement activation products (CB-CAPs)” – differentiated FM from lupus as well. Calling lupus the “prototypical autoimmune systemic disease in which hyperactivity of the immune system and production of autoantibodies lead to a variety of symptoms including chronic pain, arthralgia, fatigue, morning stiffness” and organ damage, Wallace demonstrated that these complement activation products were plentiful in lupus but were completely missing in FM.)
Few have linked – or have attempted to link – central sensitization with immune dysfunction as this group has. Gillis stated that his inquiry into FM began when he asked himself what could cause the many different symptoms in FM? The only system he could come up with was the immune system.
Sensitive AND Specific Test
Gillis said the sensitivity of the test is now up to around 99% and the specificity of the test is now around 95%.
EpicGenetics reports that the test requires about an ounce of blood and is available in most states, Canada, Europe, Turkey, Mexico, Central and South America, the Caribbean, Hong Kong, Australia and New Zealand. It states that the test is “FDA-compliant” and is covered by Medicare and most insurance plans. The company can also help FM/a® Test applicants arrange for their blood draws at a local facility at no cost.
If not covered by insurance, the test is expensive (>$1,000). Your doctor must provide authorization but EpicGenetics will even help you find a more amenable healthcare professional. (Complete the FM/a® Test Application Form.)
Why get the test?
- To rebut the doubters – whether they’re your doctor or your family or friends, that you have a real biological illness.
- To save time and money. Dr. Gillis, the CEO of EpicGenetics, stated that literature indicates the average patient will spend $4,800 – $9,300 a year for 3-5 years before all the tests prove negative and the doctor decides you have FM.
- To get the vaccine (see below).
The Genomic Test
Has Epigenetics been able to uncover a genetic signature in FM – one, as they suggested, similar to the BRCA gene in breast cancer?
The Gist
- EpicGenetics is a Los Angeles biotech firm that specializes in developing diagnostic tests.
- Two quite large studies found that the white blood cells from FM patients responded to an immune stimulus poorly by producing significantly lower levels of immune mediators called cytokines than healthy controls’ cells did.
- The CEO of EpicGenetics proposed that reduced levels of protective cytokines may be responsible for FM.
- One study was able to use the response to an immune stimulus to clearly differentiate FM patients from rheumatoid arthritis and lupus patients.
- The reduced cytokine response found in FM suggested that it was not an autoimmune disease.
- The authors suggested that FM was a central sensitization disease characterized by a reduced reaction to immune, hormonal, etc. stimuli.
- In 2017, EpicGenomics began a genomic study designed to develop a genetic signature for FM.
EpicGenetics is all in with FM. They did not stop with the blood test. Their next steps were a genomic test and a treatment trial.
In 2017, the company announced it was embarking on “Campaign 250” an ambitious effort to conduct whole exome genetic testing on up to 250,000 FM patients who have tested positive on their FM/a test. Since, at $2,500 a pop, that campaign would cost $625 million, it hardly seems feasible (or worthwhile) to test that many people. (EpicGenetics is apparently asking people who test positive for FM on their test to participate in the study.)
The company reported it had received FDA approval for a treatment trial but put it on hold pending further work on FM genomics. Not only did the company feel they were on the cusp of uncovering a genomic biomarker but they reported that biomarker validated their hypothesis that FM was an immune disease.
“We are cautiously optimistic that we are on the throes of a breakthrough in better understanding fibromyalgia. If we find these [genetic] patterns are unique for fibromyalgia, it further and hopefully will forever legitimize in the minds of everyone that fibromyalgia is a real disease, that it’s a disease of the body’s immune system, and that consequently it’ll change how patients are diagnosed and treated, and hopefully how we may be able to cure or reverse the disease.” Gillis
A second slate of studies were underway. Hoping that they could use the genomic signature to assess the effects of their treatment trial, they held it off for a year or two, and then earlier this year began the treatment trial.
The Vaccine Trial
“Given what’s been published in the medical literature, we believe this vaccine will reverse the immune system abnormalities [of fibromyalgia].” Dr. Bruce Gillis, Epigenetics CEO
Treatment Takeaways
- This year the company began a clinical trial of the BCG vaccine used in tuberculosis.
- Vaccines stimulate immune responses. The BCG vaccine stimulates the cytokines the company believes are being underproduced in fibromyalgia. The trial is expected to wrap up in 2022
- People who have tested positive for the FM/a test are eligible for the genomics study and vaccine trial.
- A similar pattern of reduced immune response to stimulation has been found in chronic fatigue syndrome (ME/CFS)
- Carl Gottfries treated ME/CFS patients (and himself) for decades using a different vaccine (which is not longer available.
While vaccines are mostly used to fight off pathogens, they also stimulate the immune system. Carl Gottfries used another vaccine to treat himself and others with ME/CFS until the vaccine’s producer stopped production.
It just so happens that the BCG vaccine stimulates the same parts of the immune system EpicGenetics believes have taken a hit in FM.
The 300-person, randomized, triple-blinded, Phase II, Mass. General Hospital BCG vaccine trial started in January of this year and is expected to end in January 2022. A call went out earlier this year for more men and younger female patients.
Gillis was clearly excited by the vaccine:
“The expectation is that if the results are as good as we hope, potentially in as little as six months, we will have further opportunity to expand the treatment to many, many more people as we collect the data. We don’t expect significant side effects and we expect fairly rapid responses to the BCG by the people who participate in the trial who receive it.”
| Contact Denise L Faustman, MD, PhD | 617-726-4084 | fibromyalgiastudy@partners.org if you’re interested |
An ME/CFS Connection?
People with ME/CFS might want to keep an eye on EpicGenetics.
Gillis has pointed out how similar the symptoms of ME/CFS and FM are. If the vaccine works out in FM, ME/CFS is probably next. In fact, the two have more in common than symptoms. Every mitogenic test done in ME/CFS has produced the same general result as the two EpicGenetics FM studies: a markedly reduced immune response.
Given that, it might be a good idea to keep an eye on EpicGenetics.
Conclusion
Is FM an immune disease? Will EpicGenetics turn the world of fibromyalgia on its head with its trifecta – a blood test, a genomic test and a cheap treatment? If it does, will it apply to ME/CFS?
EpicGenetics hasn’t reported on the results of its genomic testing. Unless they hit it out of the park with the vaccine and stop the trial early, we probably won’t know about the results of the vaccine trial until 2022.
Will EpicGenetics epic plans come to fruition? Breakthroughs, as we know from experience, don’t come easy in medicine but sometimes they do come. A cheap way to treat FM (and maybe ME/CFS) – even if it was a partial treatment – would be a godsend. Time will tell.
Update – as of Nov 2021 there’s still no sign of an EpicGenetics trial in sight. In fact, an investigative report “In a sea of skeptics, this physician was one of fibromyalgia patients’ few true allies. Or was he?” done by STAT news that digs deep into the founders rather unappealing past suggests one may not be forthcoming at all.
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Maybe you’ve heard of the FM/a test before but I’ll bet you’ve never heard it like this – an attempt to fully cover it, put it in the context of past findings and wrap up the blood test, genome and vaccine trial in one nice ball.
If that kind of report supports you, please support us!
Glad u are covering the FM/a test. was wondering about it.
Question, has Epigenics company not included ME/CFS samples in addition to the lupus test sample they’ve run on purpose?
Wondering if they had separately run some me/cfs samples and found that their info sets would not as yet differentiate between FM and ME/CFS?
Or if CFS /ME was not included because of already known cytokine response similarities between FM and ME/CFS?
So that they may have already postulated that including ME/CFS would show a current lack of specificity between them?
(and therefore make the specificity lower than 99%?)
Had been trying to find info online before this article to answer this.
Great synopsis Cort, thank you!
(Q:perhaps a future report will be on Iquity’s Isolate FM RNA
test? https://www.google.ca/amp/s/www.practicalpainmanagement.com/amp/25085
and update on Griffith/Menzies Australian test?
https://www.google.ca/amp/s/meaustralia.net/2016/03/03/griffith-uni-claims-breakthrough-on-diagnostic-blood-test/amp/
Thanks. I wondered the same thing. My guess is the same as yours – poor specificity when ME/CFS was included.
Much better from a business perspective to go with two other diseases which FM can be mistaken for but which are different biologically.
Thanks for the tips on the other tests. I see one more for FM! Diagnostics is booming https://www.medicalnewstoday.com/articles/324735.php#1
I don’t think we’ve heard anything about the Griffiths test for the past three years despite the fact that the article suggested it might be available soon.
I have faithfully checked the fm/a test site for a date for the study. The site is never changed. I really hoped to participate in this study. I have suffered with fibromyalgia for years and want to see a “light at the end of the tunnel.”
Shirley, I recently signed up for the FM test with Epigenetics. They are suppose to be mailing me a kit for my blood draw. Now after reading some of the comments here, I’m a little hesitant to get involved with this study. The only ‘study’ info I could find is this: https://ichgcp.net/clinical-trials-registry/NCT03582085
Somewhere the Epigenetics literature mentions that Massachusetts General, University of Chicago, and UCLA will be involved with the study. A bit difficult to find solid information.
I have just received the results from the FM/a blood test which was covered by my insurance. I’ve had ME for 7 years, never considered fibromyalgia. I told the study people I have ME, didn’t think I had FM but would be glad to participate. Turns out I do have fibromyalgia. I want more info in the vaccine they’re studying which they are sending but I doubt I have much to lose in giving it a shot
I called (2022–but it sounds like they did the testing before this year), they already tried the TB vaccine (BCG) and it did not have the results they wanted so they decided to go another route.
Disappointing as that is, I’m more disappointed that they have not been sufficiently clear, with those of us who have been so ill for so long and so mistreated in the medical field, about the specific fact that the TB vaccine treatment is now off the table and they are pursuing a different avenues. Don’t be vague, don’t trawl us along.
Why is that a secret? Look how many wait on the their FB for a glimmer of when the testing of the vaccine treatment will start. 🙁
There was this study in 2018 publicized by Solve ME/CFS for a biomarker run by David Kaufman.
https://solvecfs.org/research-study-information-from-dr-kaufman/
According to OMF public financial information they funded David Kaufman and EPICGENETICS in 2018, so it could be this study.
I’ve not seen anything published to date.
Wow…I had no idea about that Kaufman diagnostic study. The Solve CFS page said:
“If you choose to participate, you will be asked one time to donate your blood that will be used to evaluate an FDA-approved test for another disease, fibromyalgia”
That sure sounds like EpicGenetics.
You don’t happen to have a link to the OMF info do you? I had never heard of that either.
Question: is it FDA approved, or FDA compliant?
Website says FDA compliant
As a project manager running global clinical trials, I question their methods. . I had a positive FM/a test done in 2018 and paid to submit my blood for Campaign 250 but have not had any updates on the actual clinical trial. There is some concern that Epigenetics will continue to delay the trial indefinitely as they keep changing their story. First they said they only needed FDA approval of the trial to begin, then they decided to add other sites, then said the population of positive results wasn’t diverse enough so they require more men. It’s completely unnecessary to delay an entire trial waiting for more men to test positive since FM is predominantly a female disease. Now today I see for the first time that the trial won’t begin until a new goal is reached. From their website “However, we will be recruiting for the Clinical Trial once the results of the genomics study is published.“
I’m curious to hear your thoughts on the ever changing starting point.
Interesting! I had no idea. I see from the clinicaltrials.gov site that the trial was slated to begin in Jan of this year. I thought it had already started but it’s still in the “not recruiting phase”.
https://clinicaltrials.gov/ct2/show/NCT03582085?cond=Fibromyalgia&draw=2&rank=3
You’re right the bar keeps changing. They stated in 2017 they were delaying the trial pending the genomics study results. I wondered about that but didn’t put it in the blog. I don’t understand why a genetic marker – such as the BRCA gene which they referred to – would help them assess the effects of the BCG vaccine. A gene expression or epigenetics result – yes; but not a baked in genetic polymorphism. That’s not going to change yet they referred to the BRCA gene regarding the genomics study.
I don’t know why it’s necessary to publish the genomics study – which can take a godawful amount of time – prior to getting the trial underway. Do they need a publication to include genetic testing in the trial protocol? You would know better than I.
I also don’t understand why men’s genetic results would have any impact on women’s genetic results. I wonder if they needed more data for the men’s arm of the trial. But why would that stop the women’s arm of the trial? This is supposed to be a three year trial – why not get the women started? The trial has now been delayed almost a year.
I don’t know what they are getting by delaying the trial. Could they be delaying the trial in order to raise more money for it (via their FM/a testing profits?)
I have sent those questions into them and I asked about the award I couldn’t find and about how IL-6 and IL-8 could be protective.
If this it true, does this void the information in your article? Another smoke & mirror show to get out hopes up?
I have experienced the same problem. I have Fibromyalgia and took the FM/test in 2018 (insurance paid for it) and was promised that if it was positive I would be offered the vaccine trial that would start in January 2019.
When I contacted them in January I was told that they had so much response that they were giving as many people as possible a chance to take the FM/test. Then when I contacted them awhile later they told me that they needed more men to apply to make it a legitimate study.
Then when I inquired again they said they were focusing on the genomic testing (they are comparing the similarities of those who tested positive). But they said I wasn’t automatically included and that I could volunteer for it but I would not be told the results. I offered to do it but received lackluster response from them and besides a generic email they haven’t followed up with me to be included even though I tested positive on the FM/test. They continue to reassure me that they will contact me immediately when the vaccine trial begins.
As of the end of December 2019 I do not believe they have started the vaccine trial. If they have they are lying to me that they haven’t. I keep getting the feeling that they are either stalling to make money on selling the FM/test or else they are having some other problems that they won’t admit.
I had high hopes for this and really wanted to be in the trial, but so far I feel like Dorothy when the curtain was pulled back on the Wizard of Oz. It would be great if you could investigate them further.
I sent some questions. I hope they will answer.
We’ll see. Lots of things can come up with these studies and trials and they are often delayed – sometimes incredibly so. The people in charge sometimes compound the problems by either being effective communicators. They certainly have been provided an opportunity to communicate and clear some things up.
My hope is that this is more of that – things have come up that are delaying the trial – and that it will happen at some point.
EpicGenetics is very good a putting out press releases and pithy video’s – which is not bad – but they don’t provide much in depth information on their website.
Here’s the reply I received from Epigenics when I inquired this week.
The FDA-approved, planned treatment trial has not commenced because of our preliminary results as they concern our research regarding the genomics of fibromyalgia. We have a partnership with the Genomics Laboratory at the University of Illinois College of Medicine at Chicago to investigate the potential sources of fibromyalgia(FM). The initial phase of that research uncovered unique DNA-related patterns that were found only in FM patients and not in otherwise healthy control patients. Hence, we commenced a second phase of the genomics research in order to confirm those initial results and it is ongoing. We are dedicated to try and uncover the pathways that cause FM. And, it would be premature to begin a treatment trial without knowing what those specific pathways are and how they react to the treatment vaccine.
We are also investigating the potential initiation of a separate treatment trial for the control and management of the pain that is associated with FM.
As we make progress in these pursuits, we will be contacting those who have been confirmed to have fibromyalgia via the FM/a® Test. We ask for your patience and understanding as scientific research is a journey and not a sprint and no matter the resources we devote to these research investigations, we cannot predict what we will identify nor how long it will take.
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I am new here, my name is Cindy.
I am a former Investigator. I found this site, while looking into Epicgenetics for my own information
You don’t know me
but you might be interested in this link for the FDA archives.
If you look at the income Epicgenetics made,($750K in the first month), that might answer the questions of why there are so many delays.
I was not content to just look for FDA warning letters, (there aren’t any), I went to the archives.
That is where I found the information at the link below.
Cheers,
Cindy
https://www.archive-it.org/collections/7993?q=Epicgenetics&show=ArchivedPages&hitsPerDupe=0&go=Search+the+Archive
Can you help me…my story is lengthy, but I can share it. I had tge FMTEST.COM EPIGENETICS Summer 2020. Please Check our my FB personal at Titia Feather or Group Surviving Implants From Sientra SB
https://www.healthrising.org/blog/2015/11/21/gottfries-chronic-fatigue-syndrome-story/
Readers might be interested in your earlier article, Cort, on Carl Gottfries’ successful vaccine treatment for what appeared to be prolonged post-viral fatigue (ME/CFS). He came up with this idea himself and used a vaccine which combined a form of staph and another toxin, with the purpose of stimulating the immune system. It worked on him and I believe on others too (my memory is fading) but after him was discontinued?
Please correct or add to my recall!
Thanks! I just added it. Correct. Gottfries provided the vaccine to himself and his patients until the manufacturer ended production of it. He apparently bought enough of it up to have a supply for himself for several decades.
Those clever, enterprising Scandinavians! I will put my money on them every time.
A few of us were able to try a similiar vaccine to what Gottfries used. @Hip even contacted Gottfries and apparently Gottfries tried the new source. I believe he said it worked but none of us who tried it had much effect.
The several year saga is described here https://forums.phoenixrising.me/threads/staph-vaccine-to-treat-cfs.3788/
Haven’t we seen runarounds before with trying to get FDA approval? Ampligen, for just one example? Why is it hard to get promising new drug treatments for certain conditions—maybe the less prominent, well known or funded conditons—and yet pharmaceutical companies are coming up with new drugs all the time—which offer incremental or even no benefit? We see these all the time. Is the FDA a bureaucratic roadblock to intelligent new prospects while at the same time being an enabler of the goals of major drug companies? (Am I just paranoid or prejudiced? I hope so.)
The drug approval system is clearly broken. It’s another case of controversial diseases having added barriers.
It’s simply too expensive to get a drug approved- and there’s no help for neglected diseases. The NIH and FDA should find a way to provide that help. How about a drug trial system aimed at supported people with neglected diseases?
Instead it’s all profit-driven and companies can make more money more easily tweaking cancer drugs than taking a shot at something like ME/cFS. The fact that there’s no good target to shot at in ME/CFS or even an animal model – throws up more roadblocks. The lack of research funding and the lack of drugs for ME/CFS goes hand in hand.
Pharmaceutical companies reap big profits from chronic diseases without solutions. Is it possible they could assert an influence?? Who would imagine the stranglehold on recognizing the existence of lyme, denial that some people with health issues should not take vaccines.To me, their refusal to be more helpful is way over the top. They have crossed the line as they did with the lyme community.
Time will tell. One group of researchers does believe they’ve developed a good Lyme test, by the way.
I have followed the progress of EpicGenetics in FM closely but could never find a good rationale for how the reduced cytokines mentioned in the above studies tie in to the pathophysiology of FM. What is also a question for me is- would those of us who had autoimmune diseases prior to developing/ being diagnosed with FM also have the reduced cytokine production or not? I don’t really buy in to this testing method, because isolating cells and stimulating them with broadly activating compounds can only tell you that there is some dysfunction but not about what is going on in the body itself. And I agree with Cort’s comment, in what way are IL-8 and IL-6 thought to be protective? Perhaps not specifically in the context of FM but just in general as part of a pro-inflammatory response? I really want to know how the BCG vaccine could reverse FM. I find the scientific rationale for the treatment totally lacking until someone can at least posit a theory about why reductions in these cytokines would play a role in the cause or symptoms of FM rather than being a byproduct? Also, for good reason ME/CFS patients are wary of vaccines. The BCG vaccine is like taking a hammer to wake up three immune system in a non-specific way and that’s why it is used as an adjuvant for certain cancer treatments, because it so strongly activates the immune system. Given the systemic problems in FM I’d be hesitant to do something so dramatic.
On the plus side there is Daniel Wallace – a very well published UCLA researcher.
I also found a way for IL-6 to be protective: It’s actually both pro-inflammatory and anti-inflammatory depending on where it’s produced:
and an anti-inflammatory myokine. IL-6’s role as an anti-inflammatory myokine is mediated through its inhibitory effects on TNF-alpha and IL-1, and activation of IL-1ra and IL-10.
https://www.wikiwand.com/en/Interleukin_6
Who knew?
IL-8 is tougher – increased levels are associated with a bunch of diseases but it does have some positive effects at the proper level:
It induces chemotaxis in target cells, primarily neutrophils but also other granulocytes, causing them to migrate toward the site of infection. IL-8 also stimulates phagocytosis once they have arrived. IL-8 is also known to be a potent promoter of angiogenesis. In target cells, IL-8 induces a series of physiological responses required for migration and phagocytosis, such as increases in intracellular Ca2+, exocytosis (e.g. histamine release), and the respiratory burst.
https://www.wikiwand.com/en/Interleukin_8
Emily, PLEASE find me on FaceBook and message me. I would like to get your story. I am a Federal Healthcare Advocate and Lobbyist. You can also find me on Linked In.
i also took the test Two years ago never heard another word. im suffering and feel scammed
Still think you ought to look more into fibromyalgia and oxalates:
https://www.kevinstock.io/health/health-dangers-of-oxalates/
They can cause inflammatory cytokines too:
https://www.frontiersin.org/articles/10.3389/fimmu.2018.01863/full
Thanks again, Learner1
No wonder I feel sick after eating all that stuff that suppose to be good for me..First Article
Second Article is way over my head like the sky..lol!?
I think we know too much about food now. By the time I eliminate gluten, dairy, the foods I tested allergic to, sugar, pesticides, mold, phytoestrogens, refined carbohydrates, carbohydrates, meat that isn’t free range or grass fed, pre-packaged food, and now plant foods, I’m not sure what to eat.
I too have followed Epicgenetics, fm/a and Dr. Gillis closely. I have been cautiously optimistic and impressed early on if not a bit skeptical but that skepticism is growing. I tested positive for fm/a early on once insurance covered the test. I spoke with Dr. Gillis directly who answered my questions and was very helpful. I was impressed. Dr. Gillis advertised in articles a free genetic test to determine the underpinnings of the condition for those having a positive fm/a, but this turned out to be a small charge and not free. I still paid it even though no individual results would be returned. I was happy to help if I could, but it concerned me that it could be a sign of profiteering in some way. Epicgenetics registered with Mass General Faustman Lab for a trial using a certain strain of the BCG vaccine-impressive. The Faustman lab is world renowned for research in treating type 1 diabetes with BCG. They are well respected. I would call for updates to the lab and they were optimistic and encouraged me to call back for updates. Now it seems my calls to get updates at the lab reveal some frustration as Gillis has held up the trial-red flag. The genetic test results are still not announced-red flag. My calls to Epicgenetics on updates were once answered courteously, now annoyedly-red flag. I cannot help but wonder if a lot of the announcements are to drum up business for a very expensive test they sell-always a risk. Added to my skepticism is Dr. Gillis had a similar test years ago for PTSD that many experts felt overpromised and lacked validity before he discontinued it. Lastly? I received an explanation of benefits that Epicgenetics billed my insurance again over 2 years after my original test was done. I need to inquire further but another red flag. Red flags do not mean anything but a more possible risk or disingenuousness not a full indictment and the best of intentions may be present. However, while I hope I am wrong, few Fibromyalgia experts I’ve consulted know anything about this test and fewer put any credence in it so far. I truly hope in time this test will prove itself, so far I’m becoming more doubtful.
Thank you for the details on your experience. It’s similar to mine. Here’s the latest update when I reached out to them in October 2019:
“Based upon your FM/a® test score, if you receive a positive test score you will be enrolled in our records as being a candidate who will be asked whether you want to become a volunteer for the treatment trial.
We have been in partnership with the Department of Pathology of the University of Illinois College of Medicine at Chicago to investigate what causes this cellular disorder via genomic studies. We have made significant progress. Therefore, we must complete these genomic analyses before commencing the treatment trial since we must know exactly how to monitor how the treatment vaccine impacts these DNA-based factors and confirm the vaccine’s efficacy and long-tern effects.
We hope you realize that EpicGenetics has not merely been interested in being able to diagnose fibromyalgia. We are dedicated to attempting to discover how and why a person develops fibromyalgia and to develop treatments that will reverse this disease.”
Nancy, please contact me on FaceBook or Messenger. Or via Linked In. I would like to get your story. I am a federal healthcare advocate and lobbyist.
I’ve recently read they have partnered with the Mayo Clinic. That sounds promising!
That is promising!
Hey people,
ist there any platform where you gather the new information on the BCG and FM/a test?
Do any of you know if fibromyalgia poses any more significant risk to COVID 19?
I share you skepticism over the FM Test. Lots of advertising for it on XM/Sirius radio as if the study is imminent but the study keeps being delayed for some reason.
Dan,
I feel for you. I have been fighting Fibro for years and I thought the same thing. According to a few doctors that I’ve asked said no it didn’t make you a high risk person. As for it doesn’t affect the immune system. Also, that the meds you take don’t make you a high risk neither. You would be considered “healthy”.
Below is an email I received from EpicGenetics on 4/19:
We at EpicGenetics are dedicated to supporting everyone with fibromyalgia. We have received many inquiries as to whether those with FM/a® Test proven fibromyalgia are more susceptible to contracting a Corona virus infection because they suffer with an immune system deficiency which is due to abnormal functioning regarding their immune system peripheral blood white blood cells. Consequently, we want to stress that if you have a positive FM/a® Test score, please take extra caution. Please maintain social distancing. Please limit leaving your homes. And if you do indeed receive a positive Corona virus infection, please tell us immediately as we need that information so that local public health authorities can be made aware and so we can see if additional treatment therapies must be provided to you.
Thank you,
Jeff Bellar
Director of Operations
EpicGenetics, Inc.
11801 W. Olympic Blvd
Los Angeles, CA 90064
Tel: (310) 268-1001
Fax: (310) 861-9004
E-mail: jeff@epicgtx.com
http://www.fmtest.com
I took the test. Tested positive and never heard another word.
Carol, please find me on FaceBook and Message me, or on Linked In. I would like to get your story. I am a federal healthcare advocate and lobbyist.
Carol,
There’s a very well researched article in STAT magazine about EpicGenetics and the test. If you took the test you should read it.
https://www.statnews.com/2021/10/20/selling-certainty-epicgenetics-physician-was-one-of-fibromyalgia-patients-few-true-allies-or-was-he/
Best,
Alan
A COVID update from EpicGenetics:
The other research relates to how fibromyalgia patients respond to a Covid-19 infection. We have a hypothesis that the immune system deficiencies in fibromyalgia may lessen the effects of such an infection. Therefore, we are working on a new Covid-19 antibody test to use on FM patients. Please check our website weekly for related announcements, because if we successfully develop this antibody test, we plan to offer it at a no cost lab fee basis to everyone who undergoes the FM/a® test.
I am a woman who was diagnosed with Fibromyalgia several years ago. I am scheduled to take the test soon. I was just looking for verification that this company was legitimate.
Wow… I just received an email that my insurance will cover the FM/a test, and now I’m very hesitant to go forward. However, as restrictive as insurance is these days, wouldn’t they be the first to say no to the test? Just another question to confuse the issue, I guess? I thank you all for your input. Here’s to all of us finding a cure someday!
Hi Betty,
I recently looked into getting the test, and EpicGenetics is suppose to be sending me the kit for the labwork. After reading some of the comments on here, I am hesitant to do this.
I agree with you on why the insurances are paying for this test. Medicare refused to pay for my yearly breast MRI last year (have been having one for several years due to extensive family history of breast cancer). But EpicG stated that they got insurance approval! What?? Maybe I need to make a call to Medicare?
Did you ever have the test done?
I was part of the clinical trial to develop this blood test back in March of 2011. I was accepted into this clinical trial even though I had other concurrent chronic illnesses, most notably chronic Hepatitis C and Type 2 diabetes. I was told I tested negative even though I had been diagnosed with fibromyalgia in 2005 and continue to carry that diagnoses to the present day.
After I participated in this study, I started reading up on Dr. Bruce Gillis after I couldn’t get a copy of my signed informed consent form from his office, which was then in Santa Monica. What I discovered is that Dr. Gillis worked as a Worker’s Comp doctor. He’s tried to use his cytokine research to disprove that people in the Workers Comp system were ill due to work-related exposure to toxic chemicals.
https://www.businessinsurance.com/article/20071111/story/100023379/genetic-test-for-toxic-exposures-tapped-to-fight-workers-comp-suits#
When he was unsuccessful in these pursuits, he happened upon fibromyalgia to refocus his research.
I reached out to the University of Illinois, an organization he claimed ties to in developing this blood test. I wanted to file a complaint about not receiving a copy of my informed consent. I never received a return call from them.
In 2013, an article entitled Despite Researcher Criticism, EpicGenetics’ Fibromyalgia Test Does $750K in Sales in First Month came out. I was interviewed by the author Adam Bonislawski and shared my concerns about Dr. Gillis’ work.
From the article:
“I don’t personally think that [the FM/A] test has any diagnostic value given what we know at present,” Daniel Clauw, director of the Chronic Pain and Fatigue Research Center at the University of Michigan and a fibromyalgia expert, told ProteoMonitor via email.
“These results are out of line with previous results of cytokine assays that either showed normal or increased (not decreased) levels of cytokines,” he added, noting that given this inconsistency with previous studies, additional studies evaluating the Epic markers were required.
In particular, he suggested the researchers replicate the results in a different sample cohort and have another independent group replicate the results.”
I do not think that there have been any other independent medical research studies done to validate Dr. Gillis’ results.
Unfortunately the article it is behind a paywall:
https://www.genomeweb.com/proteomics/despite-researcher-criticism-epicgenetics-fibromyalgia-test-does-750k-sales-firs#.XxlpLLdlB0o
To this day I believe I was accepted into this trial so that Dr. Gillis could use my blood – knowing my other medical conditions – to see if they fit with and advanced his cytokine hypotheses. And while all of us here are desperate to have our diagnosis confirmed and to have another treatment option to try, I would suggest you do your due diligence before you spend hundreds of dollars on a FM/a test.
Selena, please find me on FaceBook and Message me, or via Linked In. I would like to get your story. I am a federal healthcare lobbyist and advocate. Thank you. I am compiling stories about this.
Selena,
There’s an article in STAT magazine about the test and Dr. Gillis. It’s called “Fooled by Certainty”. Please read it.
https://www.statnews.com/2021/10/20/selling-certainty-epicgenetics-physician-was-one-of-fibromyalgia-patients-few-true-allies-or-was-he/
Best,
Alan
Please take my name off your list. I changed my mind.
So Epicgenetics is looking for 250,000 people to test at over $1000 per test.
And they are offering to get you involved in a clinical trial-MAYBE- which has no record of ANY success.
$250,000,000 for hope
Good business, bad medicine
Jay Tendler,MD
Jay,
There’s an article in STAT magazine about the test and Dr. Gillis. It’s called “Fooled by Certainty”. Please read it.
https://www.statnews.com/2021/10/20/selling-certainty-epicgenetics-physician-was-one-of-fibromyalgia-patients-few-true-allies-or-was-he/
Best,
Alan
I, WAS TAKING THE FM TEST…BUT , I DON’T CARE TO SHARE SO MUCH INFO, WITH YOU.. I NEED THE HELP THO!!!
ow long does it take to hear the findings of this test…….I have been waiting a long time for results;
Kathy,
There’s an article in STAT magazine about the test and Dr. Gillis. It’s called “Fooled by Certainty”. Please read it.
https://www.statnews.com/2021/10/20/selling-certainty-epicgenetics-physician-was-one-of-fibromyalgia-patients-few-true-allies-or-was-he/
Best,
Alan
Has anyone heard/read any updates about ANY of this??? Anything at all? A friend recently saw the commercial EpicGenetics is running and let me know about it. I immediately started looking into it and came across this article and read all the comments here. I am HUGELY sceptical now. But…..it’s now April of 2021 and I would love to know if they’ve had any progress or are they STILL delaying everything.
Anybody?
Ryn: I placed a couple of comments above. I think they are still selling their testing kit. I recently signed up to have the blood draw and am waiting for the kit. However after reading all of the comments above, I’m also skeptical now. I may send the kit back and cancel everything!
After all this time, why hasn’t something more definitive been done in the way of a study? Or why hasn’t the government taken this business down if they’ve been going on over 10 years and just taking people’s money?
Rose Moore: I’m not comfortable giving my blood to a company who, according to just these comments alone, isn’t communicating with their customers. What are they going to do with those blood samples after they test for FM? Are they going to use them for more research? Are they getting permission from their customers to do that…or anything other than testing for FM?
Their website is seriously lacking transparency and further information. Since he “partnered” with the Mayo Clinic why haven’t THEY done anything with all that info? He used research that other people had done and created his own research which led him to making the discovery of that certain protein we seem to have in our blood, then created a test that would find it. That’s HUGE! But he hasn’t done anything else with that info. Why not? Is the government standing in his way? Is he not interested in going any further with it? I mean, he put ALL of his findings onto the internet for others to read and use. I personally don’t think he plans to do anything further. Think of how much money he could get (grants/funds/sponsorships) to really do something with it – to create a treatment or cure! There is a lot of money to be had in the Western Medicine field for something like that for FM. Hell, the supplement companies would be all over this. It’s like all he wanted to do was create a test for FM and then let other people use it for their own benefit. And finally…..as huge as this is – WHY ISN’T THIS PLASTERED ALL OVER THE INTERNET AND NEWS CHANNELS?!?!?! So many of us have FM and would gladly take out a second mortgage for a treatment or cure…..there IS money to be made with this info he has. And what did he do with that highly-sought-after info? He put it all out there for everyone to see. No money for him. See what I mean? Why would he do that? So, I don’t think he’s going to do anything with that research. (Besides, it shouldn’t take over 10 years to get a trial going, if you’re doing it by-the-books and everything is on the up and up.) So…..what’s going to happen with all those blood samples he’s gotten? Who’s going to end up with all that highly personal DNA material and what are THEY going to do with it?
So I won’t be doing the test, not until all my questions have been answered. My doctors and I know I have Fibro. We don’t need a blood test to confirm it – but – I would love for someone to do something with his research. Sigh. I suppose it’s just more waiting.
At least he’s done something that NO ONE else has been able (or even wanted) to do. I mean, Fibromyalgia can actually be detected in blood!!!!! No more denying it exists! Except, no one in the general public or general medical field seems to know about this test.
Rose,
There’s an article in STAT magazine about the test and Dr. Gillis. It’s called “Fooled by Certainty”. Please read it.
https://www.statnews.com/2021/10/20/selling-certainty-epicgenetics-physician-was-one-of-fibromyalgia-patients-few-true-allies-or-was-he/
Best,
Alan
I am a man, and was a participant in the FM/a test trial. There was an optional additional trial, for people who test positive, to allow there blood to be studied for a possible Covid immunity. I agreed, thinking I was doing my part to help. I had my doctor look everything over. He is one of the smartest people I know and I trust him. Everything looked above board on paper. They promised me the same thing about being notified right away as soon as the trial for the treatment began. I called them when I heard nothing and they told me that there was no trial yet and I would be notified as soon as there were one.
I also recently saw an article online that asked various FM/ME/CFS experts about whether or not people with these conditions should get the Covid vaccine. Dr. Bruce Gillis said something like, “absolutely. There’s no reason not to get the vaccine. They should definitely get it.“ I’m starting to wonder if these Covid vaccines or somehow linked to epic genetics and if people who participated in this trial were somehow used to create them.
I was also told something completely different about cytokines when I spoke to a nurse practitioner at epigenetics for two hours before agreeing to participate. Something isn’t adding up. Remember, epic genetics is not a nonprofit organization. They may not be a drug company, but it is a corporation. When the motivation is the almighty dollar, can we really trust anybody to be a true healer?
I am regretting allowing them to study my genetic material for whatever that second trial was really for. And why are some people who were previously healthy experiencing FM/ME/CFS symptoms after getting the vaccine? And why are so many people with these diseases having flareups and relapses, Some of whom say that they are permanent? Is there a connection? I’m starting to doubt that anybody in the “Healthcare” industry is really about health or care
All that sounds suspicious to me, too. I had not thought about a connection between this company and the vaccines. Hmm.
Is there a way you could contact EpiGenetics to request updated info about the trial(s) AND what’s been done with your specific genetic material? Email would be preferred and I would request the paper trail of my blood test and exactly where it went, who handled it and what was done with/to it and where it is now. It sounds as though you wouldn’t ever get anything in writing – and I’d be willing to bet they’d claim no paper or digital trail because they “disposed of the sample”. I’m not trying to start a conspiracy, I just can’t find any other info on EpiGenetics, the Mayo clinic partnership or the trials EpiGenetics has claimed to be trying to do….not to mention what they’re doing with the blood samples.
I hope you find some good answers.
P.S. (My husband caved and got the Pfizer shot and had a few “normal” side effects…headache, muscle soreness, dizziness, but nothing like what others are experiencing. I’m REALLY hoping he won’t regret it down the line.)
Hi Ryn,
I think you’re right on EpicGenetics. Look at this article in STAT magazine on the test and Dr. Gillis,
Best,
Alan
https://www.statnews.com/2021/10/20/selling-certainty-epicgenetics-physician-was-one-of-fibromyalgia-patients-few-true-allies-or-was-he/
There’s an article in STAT magazine about the test and Dr. Gillis. It’s called “Fooled by Certainty”. Please read it.
https://www.statnews.com/2021/10/20/selling-certainty-epicgenetics-physician-was-one-of-fibromyalgia-patients-few-true-allies-or-was-he/
Hi Alan, thank you very much for that link! It’s amazing how long this guy’s been getting away with this fraud. And it IS fraud. Absolutely insane.
I just hope someone, somewhere will take his info and the info that Faustman’s lab has and really do something with it…soon. Too many of us are truly suffering; there should be more research into this.
There are so many different alternative/natural things to try and I’m always on the lookout for more info. The only thing I’ve found to do anything for me so far is Curcumin. It completely stopped the tingling in my arms, hands and legs. I was watching a Dr. Oz show YEARS ago when he talked about it briefly. He made sure to say “look for 95% curcuminoids and whatever supplement you choose needs to include black pepper extract to help with proper absorption”. So. my research found only one that fit the bill…..Doctor’s Best brand. It’s about $25 for 120 capsules – it’s the only thing I order on Amazon. Somewhere else in my research mentioned taking it twice per day for 6 weeks then just once per day if it works for you. I did just that and by the time 4 weeks came around, I realized the tingling was completely gone. I couldn’t tell you when it stopped, it was so gradual that I didn’t notice. You’d think I would know precisely, down to the second, when it stopped. Anyway, I now take one capsule every single day, in the morning, midway through breakfast. I will caution though – must take with food!!! It will burn like a son of a bitch if you don’t! It floats around in your stomach and will come up if given half a chance. Also make sure to eat some healthy fats when you take these capsules.
My symptoms started in 2010 but I denied it for two years. I couldn’t possibly have the newly circulating, disease of the day. Not me.
Finally couldn’t take it anymore and luckily, my GP recognized the symptoms and referred me to a Rheumatologist who immediately knew it was fibro and then confirmed it with his own testing protocol. So I was one of the very few who was diagnosed quickly. I was extremely lucky in that regard. We believe it was triggered by having my gallbladder removed in 2010 because of Gallbladder dyskinesia I’d had since 2004. It’s been a really frustrating journey and getting older just doesn’t help things.
I don’t know if you need this information, but I’m passing it along in case you or someone reading this does.
Thank you, again, for the link. Seriously.
Now I KNOW my suspicions were spot on. And so does everyone else.
Best to you as well.
I would like the kit to become part of the study.
I was going to do the test. But after all the comments. I want more progress, and something more believable.
Good idea.
There is an article in STAT magazine about this test and Dr. Gillis.
I suggest you read it before paying for this test. It looks like a scam to me.
https://www.statnews.com/2021/10/20/selling-certainty-epicgenetics-physician-was-one-of-fibromyalgia-patients-few-true-allies-or-was-he/
Thanks, Alan for providing this. I updated the blog to include it.
You can get BCG in Mexico through Myco Medico
Researchers, Scientist etc ..come on with all the scam talk and amount of money they made,..do you take prescribed medication? How much research did you do..did you find published papers the study research the odds you did I am going to guess is Nil but quick to jump about omg they have my blood.,hello..everytime you get a blood draw
Do you ask what they do with it when the test are done hey they have your blood and lots of it. I have been dealing with severe fibro since 2005 and of all this time I being someone that does the research etc was surprised and hopeful that perhaps they could be on the right track..suptance P was a theory with Scientist in Sweden then it was the blood flowing into the brain is smaller than normal and effects the pain management. Area..soo many theories this one however I read a paper that in great length and detail about the Il6 and iL8 not being someone who understood any thing I was reading started self educating myself so I could and of all of the theories this whole time this one seemed to be closer as to why nothing has worked to quiet it down. Honestly trial..error etc if you think they are shady because they are not getting back with you ..300,000 plus people are wondering that too..how can they constantly get back to every single person all the time? Perhaps they have not started the protocol because research is still going on and then then covid
I have RA which is autoimmune for whatever reason my T cells yell out for more that sets off the b cells and so on and no reason why this happens but infusing my body once a month with a biologic to suppress my immune system is the only option could slow down the progression of the joints that haven’t been Frankensteined yet or the other side of it is great chance of developing cancer…why is there not any research done to figure this out my once a month infusion is over 10,000 my brother who has MS feels bad for me which wtf. Don’t hate I am not sure what they are doing but who knows medically and pharmaceuticaly what any of them are doing..perhaps something else was found in their research …anyhow I still have hope soo many people on forums groups of fibro do not know about the test I do know my sample was sent to the Unniversity of Illinois..
All of the insurance companies, Medicare and Medicare are not paying for the test in a scam all together they do that everyday and to the lady that could not get her MRI..what did they say? I am guessing please don’t yell at me but your last was
Was clear and they will do one next year those tests are insanely expensive conspiracy theories based on what I have heard are not legit and that STAT article please stop telling people to read it more theories and no citing of anything he claims that is not reporting and citing links to blogs where someone is doing the same thing with no actual proof I in college as anyone else was told if I put information in an essay I had best be able to back it up with legitimate citing. Also…how many got all 4 doses of a vaccine that had not been in a trial study but you were ok because it was covid but you are quick to shut someone down who is perhaps doing more research..other than chronic fatigue is there currently anyone else with different theory or researching different theories? Anyhow I am in no way an advocate for them between RA..hypothyroidism, type one insulin dependent, serrbatic dermatitis,raynauds..plus yay for being Irish Viking hand in both I would most likely say fibro is auto immune as well and from my research the only way to get it to stop however the damage my damage can’t be undone but could all stop is getting stem cells that they say is not morally pc..that is what they said right? You should question that ..they have asked for a tube of blood yes they made money look at your big pharma Took my 24 year old a second to brain ..oh that is why they don’t allow it here that’s bullshit the money they get for me a month ya how much did Pizer make when they rolled all their unstudyed vaccines onto everyone? I am just trying to say just let us have hope man ok because my situation to have pain not be pounding and screaming at me 24/7 365 days a year…hang in there all of of you perhaps something has been discovered somewhere hope ..positive positive this company is not hurting you if anything I would think it is a good thing they don’t want to rush to a trial with a new protocol.be safe and keep persevereing ..and me I am wishing to win the lottery to go get stem cell treatment ..and before you say anything I know people who have one with MS he still after 5 years feels great no flares no progression no injections the other had Crohn’s and was sero negative for the Ana nuclear test. Lupus.her chronic fatigue gone no intestinal issues smiles all the time and living life..so pipe dreams! Again not trying to advocate for that treatment to anyone just saying..I wanna live life pain free without losing anymore joints and so on..and lol no citing here it’s all info from me
Victoria.mcknight@facebook.com