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Skepticism Arising - Is the FM/a Test for Fibromyalgia Based on Legit Science?

Science is moving field. Research is always evolving, and, really, so too should our perspectives. This is why it is integral to focus on specific areas to become familiar with the body of work at large to understand the full context of where a piece of new information fits.


In these uncertain times, people are pulling articles, reports, and small studies out of their larger canons and praising them as truth. This is such a dangerous and irresponsible thing to do.


As a journalist, it's my job to never stop searching, reading, reviewing, and thereby reforming perspectives as new, legit science is released. It's my mission to see through the bullshit, but I know my limitations (we all have them). I've been telling myself to hone-in on one specific area of research for some time now — there is a reason why we have specialists — because being a jack of all trades in the research community equates to being satisfied with bits and pieces of complex puzzles. My (personal)* research interests include: depression, fibromyalgia, nutritional therapy, and feminism.


So obviously you know how I spent my Friday night... researching! I went back to the FM/ a test website with curiosity and a sense of purpose to learn more before actually speaking with my doctor about getting the "first, definitive" test for fibromyalgia.


Following a gut feeling


The first thing I noticed was the website had been updated since my last perusal.


A pop-up appeared with new information, including that those who are getting the test can also choose to be included in a clinical study regarding COVID-19 and fibromyalgia. Apparently there is a line of thinking here that we may actually have some advantage against COVID-19 if we test positive for fibro... Anyways... in their dropdown menu I saw a sign-up option. I'm not saying it wasn't there before, but I didn't see it last time. This time, I clicked, entered, and put in my information, including my prescriptions and the current list of vitamins I'm taking. Apparently some of the things we may take, like turmeric, can throw off the test so we need to stop these prior to getting our blood taken. I immediately received a lengthly email, with more information and more instructions, including a form for my doctor to sign and the price of the test without insurance.


I do not have private insurance. For someone in this case, the price of the test is $1080.00 USD or $1448.60 CAD.

So, I'm initially thinking,


1. I need a doctor to sign off.

2. I need to come up with 1500 dollars.


Or do I?


I mean, I have a diagnosis for fibromyalgia. It was given to me after years of tests to rule out other conditions. It was given to me by a rheumatologist in good standing and working at the St. Joseph's hospital in London, Ontario. It was given to me after a trigger point test and a case analysis conducted by a team of resident doctors working with said rheumatologist. But a "definitive" test to rule-in fibro that is FDA-compliant? This would be great to dispel any doubts.... but then I started having doubts of my own.

Red flags waving in the wind

I noticed some things last night that struck me as out of place or odd. Before going there, though, I want to tell everyone that FDA-compliancy does not equal FDA approval. It's basically a way to drop the FDA's name without actually dealing with the FDA.



1. The private company is working on a "vaccine" for fibro...



They are working on a vaccine to "reverse" fibromyalgia in those who have been diagnosed with the syndrome.


For the record, I am pro-vaccine and not afraid to say it. However, here, it struck me as odd, the concept of vaccinating against a syndrome in order to reverse its impact on your body...


Vaccines are to protect against viruses... So how would this work in the context of fibro? Also, how do you "reverse" a fluctuating syndrome? How do pinpoint what to inject us with? As per their claim that fibro is associated with abnormal cytokine activity...does this mean they'd be treating the cytokines as viruses...


No, it doesn't.


Upon further research, I found that Dr. Bruce S. Gillis from EpiGenetics, Inc. is working with Massachusetts General Hospital in their clinical trial (currently in phase II) to test the treatment of fibromyalgia-positive persons with the vaccine currently used against tuberculosis. The vaccine is bacillus Calmette-Guérin (BCG).


Now, let me tell you something. Once upon a time, about four years before I was diagnosed with fibromyalgia, I was vaccinated against TB before venturing abroad for a volunteer trip with Developing World Connections.


I have had this vaccine, albeit only once, and research shows that the effectiveness of the vaccine wears off over time.


My head is beginning to spin. Let's connect a few dots before moving on (for now).


The TB vaccine has been around since 1921. It was discontinued in Canada in our routine vaccinations in 1970. Why? Well, first, there is worldwide shortage. Second, TB isn't common here, except for in those living in First Nations reserves and Inuit communities. These persons are still vaccinated as infants and children.


But now it is being trialed for FDA approval in patients with fibro. They are to have the vaccine repeatedly over the course of three years, less they get placebo.


The logic here is that it will work to increase our immune-signalling cytokines. The trial began Jan. 1, 2019 and will end Jan. 1, 2022. Note: There are only 300 participants.


Onto the next thing that needs addressing during this post...

2. The company name who made the test.


The reason why this caught my attention is because of the Lyme disease research rabbit hole I went down the other day. After spiralling through the Lyme anxiety induced by a massage therapist, I found lymescience.org. They gained my trust, something that's not easy to do, and they had a list of blood test labs to avoid, one of which was IgeneX. It sparked my memory and led me to researching whether this place was on any watch list. Here's what I found: EpiGenetics, Inc. has been in business for 6 years. It was accredited in 2019. It has a ton of positive PR in the form of promotional articles slewed across websites. All of them read like they were written by content marketers and provide very little actual information.


From what I can garner, it is a private biomedical company with zero reviews for better or worse, leading to an A+ from the Better Business Bureau.


They have no presence on LinkedIn, and neither does the Director of Operations, Jeff Bellar. He is non-existent through Google - the site even says, "It looks like there aren't any great matches for your search," even when I add EpiGenetics, Inc. to the search criteria...He is the person who sent the email. Two other names are associated with this company, Dr. Bruce S. Gillis, the CEO and an Immunology Specialist, and Priscilla Hernandez, the insurance coordinator. Bruce S. Gillis, MD, MPH, is incorporated. His corporation consists of physicians and mental health specialists. In April 2020, they received a PPP (Paycheck Protection Program) loan ranging 150-300K.


One of the interesting things to note is that Gillis is the last-named author in the article "Unique immunologic patterns in fibromyalgia," published in 2012 in BMC Clinical Pathology. Here is why it is interesting - when the fmtest.com website refers you to resources for further reading, this is one of the only articles of eleven that directly mention fibromyalgia. The other resourcs are about TB, the existing vaccine, and trained immunity. I plan to read them all.


The second interesting thing is this particular piece of research has been critiqued, for decent reasons. I have read the article.


They claim to be working with "a large number of patients with a clinical diagnosis of FM." That number? 110. These blood samples are compared against 91 others from healthy donors.


For anyone with doubts, this is not a large number. This is not a number from which I would draw conclusions...and neither would they...note my bold prints below.


The persons with fibro showed lower levels of cytokine activity than the control group of "healthy" persons. From this, the authors concluded that, in combination with clinical patterns, a diagnostic methodology in FM could be offered and that FM is an immunological disorder. Oh yeah, also, back then, the "only definitive test" for fibro hadn't been yet patented (it was patented in 2013), and so under the guise that patients with a diagnosis of fibro who have not had the test cannot really be sure if they have fibro, those 110 persons could not have been sure, either.


As such, they were given physical examinations to "confirm" based on the American College of Rheumatology's standards, much like myself. But perhaps I digress...


Now for a few additional things FM Perplex points out regarding this study: 1. The authors did not disclose competing interests, ie). that one of their authors were going to market a test from this a few months later.


2. Cytokine levels are abnormal in many physical and mental conditions and the authors studied none of those conditions.


3. The researchers provided almost no information about patient selection or many other vital data for a comparison trial.


I started this post by saying we shouldn't pull one article out of the canon to draw massive conclusions. The authors tell us their study is significantly different from others (although they take others into account), making it a one-of-a-kind conclusion from which EpiGenetics, Inc. has based their test and now their vaccine in trial.


In 2018, a study called, "Plasma Cytokine Levels in Fibromyalgia and Their Response to 15 Weeks of Progressive Resistance Exercise or Relaxation Therapy," was published in the journal of Mediators of Inflammation. In their intro, the authors clearly state,


"There are no objective tests to diagnose FM which is why the diagnosis traditionally has been based on history and clinical examination of tender points."

Haven't they heard of the FM/a test? Don't they know about the abnormal cytokine activity found by a team including Gillis? Yes, of course. They discuss the hypotheses surrounding the cause of FM and say,


"However, previous studies have not demonstrated a consistent blood cytokine pattern in FM."

Then they dive into the studies and the different findings.


"To summarize, there is still debate whether peripheral cytokine levels are altered in FM."

In fact, in this 2018 study, they actually found increased levels of several cytokines in blood plasma - not decreased - and they say this is in line with previous studies. As far as I can tell, the authors of this study are not involved with any private companies creating an FM test, nor do they have any other conflicts of interest.


Make of this what you will, it's your diagnosis, your body, your money, your choice. For myself, I have decided to stick with and own the diagnosis I went through hell to receive and save that $1500 for a rainy day and follow this feeling further into the world of research on cytokines. Stay tuned.


*These are the topics you will find me thumbing through into the late hours, during the early mornings, and whenever/wherever I can. These are the areas in which I will never stop researching and will never come to one "final" conclusion.

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