FM/a test - bogus(?)

This is a new short article on medpagetoday.com yesterday, based on a very long and informative STAT investigation article from last week (2021/10/20). My comments (sorry, lengthy again...) below...

Bogus Fibromyalgia Test? (full short medpagetoday-article)"

A blood test for fibromyalgia is based on shaky science, but still marketed directly to patients, luring them with the promise of a high-profile clinical trial that isn’t even enrolling, a STAT investigation found.

The FM/a Test, made by EpicGenetics, is purported to be the “first and only blood test to accurately and definitively diagnose” fibromyalgia, as described by company representatives. It’s been marketed directly to patients via radio and TV ads.

People who test positive are given the promise of enrolling in a clinical trial being led by Massachusetts General Hospital (MGH) in Boston.

The problem is, the trial never got off the ground. Its sponsor, EpicGenetics CEO Bruce Gillis, MD, MPH, hasn’t provided MGH with any more of the $8.7 million he’d pledged beyond an initial down payment, STAT found.

Denise Faustman, MD, PhD, the MGH researcher who was supposed to lead the trial, was surprised to learn that the company had still been advertising the FDA-approved trial in 2020, and that it was still responding to patient inquiries with an email that mentioned the trial this year.

“The program’s on hold, he knows it’s on hold, so that’s a little bizarre,” Faustman told STAT.

Only one study was completed before the test went to market in 2012. One additional study was completed in 2015 – and it raised questions about how specific it was for detecting fibromyalgia, as it wasn’t as good at distinguishing it from lupus and rheumatoid arthritis compared with controls.

In recent years, the diagnosis of fibromyalgia has “crept toward legitimacy,” and even though progress has been made – it’s no longer seen as primarily psychological, for instance – it’s still not fully understood. It often takes a long time to diagnose, and there are some physicians who still don’t believe it exists at all.

But experts interviewed by STAT said there’s certainly no definitive diagnostic test that’s ready for prime time.

“It’s one of those tests that unfortunately, it made the commercial area before really good solid studies had been done to validate the efficacy,” Andy Abril, MD, chair of rheumatology at the Mayo Clinic in Jacksonville, Florida, told STAT.

Dan Clauw, MD, director of the University of Michigan’s Chronic Pain and Fatigue Research Center in Ann Arbor, said he gives “tons of talks. If someone asks me the question, I’ll say, ‘There is no diagnostic test for fibromyalgia.’”

Gillis argued that skepticism about the test is merely part of skepticism about the condition in general, and he insists he’s doing what’s best for the fibromyalgia community.
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The STAT investigation article on statnews.com it is based on, was written by Eric Boodman, published Oct. 20, 2021, called "Selling Certainty. In a sea of skeptics, this physician was one of fibromyalgia patients’ few true allies. Or was he?"

"Its website boasted of “processing more than 30,000 patient test applications.”

"In April, the FM/a Facebook page announced ongoing collaborations with Mayo Clinic and Johns Hopkins, among others."

Alan Silverman found it out, by phoning MGH: "in the spring of 2021, before he got the test, he phoned the research lab where the trial was supposed to take place. The person on the other end informed him — “in a sort of sharp way,” he recalled — that the lab no longer had any association with EpicGenetics. " ... “He’s really not a scientist,” said Bellur Prabhakar, a professor of immunology and microbiology at the University of Illinois at Chicago, with whom Gillis published two papers. .... According to court documents, Gillis pledged up to $8.7 million: a first chunk of $580,000, with more to follow if the project got regulatory approval. But then, after regulatory approval came through late in the summer of 2018, the next payment never arrived. .... Neither Gillis nor the hospital would say how much money he’d given by then. When Faustman contacted him to inquire about the late payments, the hospital said, he gave different responses: First, he was waiting to hear about other business transactions; then, he explained that his focus had shifted away from BCG. She kept in touch, hoping it might shift back.

About the 2015 study: But 31% of those with arthritis and 29% of those with lupus also tested positive for fibro. People can have two of these ailments at once — but the researchers had explicitly tried to exclude anyone with that sort of double-diagnosis.

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Pity for all those waiting with high hopes to take part in the trial. But "great" to see the doubts many people incl. me were having about Gillis and the FM/a test out in the open, spoken out, and his delay/ing tactics exposed. Of course some of us are exasperated by the vagueness of this invisible pain and desiring at least a test and even a cure, both of which Gillis has been claiming to provide... and it's hard to see hopes dashed, slim as they might've been. The "cure" he was targeting at in the clinical trial at MGH, Mass General Hospital, isn't mentioned here, but for those who don't know: he was wanting to test an adaptation of an old BCG vaccine (Bacillus Calmette-Guerin, the Tokyo species). Solely based on the fact that it might have helped improve type1 diabetes and MS, based on trials also done at MGH.

Also not mentioned is that what he means by insisting he's doing what's best for us is that he wanted to attempt an artful shortcut by using some of many possible but not proven biomarkers (cytokines and chemokines) to earn a lot of money (>1000$ is the price since last year) to be able to afford to run a study on a hopeful cure (this is not my way of seeing it, it's his). He was looking for 250.000 people to do the test, and we don't know exactly how high the "initial down payment" is, but to be able to pay the $8.7 million he'd've needed 8700 people doing the test...

The last sentence of the article summarizes this and out of it, but also from fibromites who support him, I hear that OTOH he is seen as a hero, but OTO that what he is doing is offering hope to the hopeless, which is something a snake oil salesman would do: Is he? We can read comments about Gillis's stonewalling of people who had done the test as well as on his apparent history of not quite clean salesmanship on healthrising). I don't know. But I just want to stick to what I've seen and haven't seen in studies, which is of course what Abril and Clauw, two of the most reputable FM-experts worldwide, also say: Cytokines and chemokines are something everyone sees and says: "Well, perhaps they are part of it". (As well as salivary biomarkers, muscle pressure, gut bacteria & serum: molecular biomarkers and altered glutamate metabolism, hormones like serotonin, noradrenaline, dopamine, cortisol, protein backbones and pyridine-carboxylic acids using vibrational spectroscopy...). However the cytokine levels have been contradictory in the past, so anything but clear, as Clauw already pointed out in 2013. And then he just comes and puts a price-tag on them. What he has been doing is definitely a one-man-show, not even letting on to his researcher that he is under cover advertising the trial. Whether deliberately or not, his test is playing on our wishful thinking, OTOH on our insecurity ("imposter syndrome"), by giving us a feeling of security about at least knowing we "really do have" our condition, and OTO him promising the cure trial is playing on our feelings & suppositions that researchers aren't doing enough for us, otherwise we would have more help, which gives us the feeling that only he is, our hero alone - despite the fact that last year pubmed had 829 studies on FM, this year should be topping that, as they have 768 to date, both more than the roughly 600 per in the decade before. If he is offering hope to the hopeless is that what's best for those who feel the need for it?: Only if he can verify his suppositions, otherwise these are going to fall hard. Maybe he has fallen for his own idea, and he is not doing it deliberately. He wouldn't be the first researcher to do so. One of the latest similar examples is the interview given by Goebel about his autoimmune study, in which he claims that he has proven that FM likely is autoimmune, despite much evidence that this is at least not all of the story, so many other researchers are skeptical about this.

And where's the "development of a genomic diagnostic test" gone to they were planning?

I don't like tendencies to conspiracy theorize about things, but this has always sounded fishy to me and it's not getting better.

**What I find strangest about the FM/a test is the 99% claim: How can anyone prove that the accuracy rate is 99% as it blatantly says on the fmtest.com-site, if there is nothing to measure with? It is only 99% certain that what is being measured is that the cytokines & chemokines are imbalanced. But it is not certain in any way that it is fibromyalgia that it is being rated. The probability that this is the case, considering all alternative and the preliminary research and comparing it to other results of FM-trials is something like 5% (just to put a number on it).**

**What I find strangest about the BCG tuberculosis vaccine trial is that no one is offering or trying it as a treatment as yet, as opposed to experimental stuff like LDN and guaifenesin. The jab is estimated to cost 20-25$, which is imaginable seeing it's 100 years old. So Gillis offering this jab "at no cost" for all those who have done his 1000$-test seems a bad joke. Especially as he is not offering it to those who have been turned down despite having got a positive test result. And it should be easy to get and cheap to pay for....**

**Who needs the test anyway?: And wdnt our quickest shortcut've been to just try his BCG vaccine ourselves? And if anyone is wary about getting the jab done, why are they keen on getting it done by him? It could of course cause problems by stimulating the immune system too much... but that risk would be there whether MGH or a local GP did it.**
I'd be interested if Medicare and other insurance will still pay for the FM/a test after this kind of press coverage, they have in the past. But if people get a positive result (which strangely all do that I've heard of...) they will tend to stop getting all of their symptoms checked up and just blame everything on the fibro, which will come a lot cheaper than the 1000$...

The page about the test on The Mighty.com has quite a few strange, but also interesting comments.
(Excerpts and links on my fibro-blog on 2021-10-28).
 
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I find this kind of stuff so disappointing. You're absolutely right, JayCS - it does have the feel of something preying on those who are most vulnerable, most likely with profit in mind. Unfortunately, I think the best thing for potential fibromytes to do is continue with the elimination diagnosis strategy, even if they do get a "positive result" from a test like this. Better safe than sorry. Without an extensive evidenced explanation of why they can be so certain that what they measure can't be rooted in other causes, or that there is some kind of measure in place for overlapping conditions, it seems like a dangerous path. The collapsed study also leaves a lingering stink :rolleyes:

On another note, I would not be thrilled at the idea of getting another BCG shot - it's pretty unpleasant. I still carry the scar from high school!
 
I think the best thing for potential fibromytes to do is continue with the elimination diagnosis strategy, even if they do get a "positive result" from a test like this.
What a brilliant, punchy, "obvious" point! (Cdnt see the wood for trees I spose...)

"getting another BCG shot - it's pretty unpleasant."
True - and it won't've gotten better now we have FM.... :rolleyes:

(Just learnt something new: I just did a right click and saw I can add emojis here with that much faster (they take ages to appear, sometimes minutes, for others too?) - but smaller 🙄- too small praps. But better than nothing if I haven't got time to wait...
Also wigh, ehm why, do none of these lists seem to have a nice *sigh*-emoji?
I think I'm gonna leave the funniest strange words I think/type wrong... - good laugh... for me at least...
And whilst we're about "learning": I still haven't figured out how multi-quotes work here: anyone?
And: I edited this and wanted to add the BCG shot as a quote by marking it and choosing "reply with quote", but it starts another reply...)
 
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I disagree with testing for fibromyalgia. Too many things need to be taken into consideration. Pain can be in a dominant or non-dominant arm or side of the body. What types of activities need to be done? It won't be the same for each person. Two people can have the same symptoms and one of the symptoms will affect daily life and quality of life for one person and the other person it will be the other symptom. And they will treat it with the same medicines anyway. Usually Lyrica or Gabapentin or something like that. It's not the test itself that I disagree with, it is the fact that I am afraid it will be mandatory to get the medicines even if they work the same if tests show it isn't fibromyalgia but they still don't know what it is.
 
The recently deceased fibro expert Frederick Wolfe (University of Kansas) slagged off the FM/a test like thus on fmperplex on 7 December 2021:

"I recently wrote an article about fibromyalgia, what it means, and how its meaning and diagnostic criteria have changed over the years. You can get the article here: [..... on cureus, "the-evolution-of-fibromyalgia-its-concepts-and-criteria"....]
Physicians and others can understand some of the difficulties surrounding fibromyalgia and its diagnosis from reading the article. One of the areas we did not address was the so-called “Fibromyalgia Blood Test.” There is no such thing as a fibromyalgia blood test that really works, but there sure is a blood test that is as expensive (>$1,000) as it is useless. A fundamental problem is that the test, even if it worked, could not be better than the criteria physicians use for diagnosis because the test has to use the criteria as its standard. That’s how fibromyalgia is defined. Use the free criteria or use the test that uses the criteria. One is $1,000 less expensive than the other and works better, too."
[.... refers to and recommends the STAT article... ]
"The purveyors of the FM/a test say that insurance pays for. But if you do a little G 👀gling you can see that such is not usually the case."
 
Locating this here despite the thread title is I think fitting cos of
the diagnosis topic, the research subforum, the "theoretical" aspect, and the post above on Wolfe.

Wolfe argued with Clauw about diagnostic definitions - Clauw supports the popular interpretation as central sensitization, Wolfe says it's more an arbitrarily defined disorder. I side a bit more with Wolfe.

This is an excerpt from the article THE TAXONOMY WAR IN RHEUMATOLOGY on fmperplex, by John Quintner and Milton Cohen on 25 August 2022.

In the words of Clauw [2014], a leading proponent of this view:

Fibromyalgia can be thought of as a centralized pain state. Centralized pain is a lifelong disorder beginning in adolescence or young adulthood manifested by pain experienced in different body regions at different times. “Centralized” refers to central nervous system origins of or amplification of pain.

Problems with this view include the assumptions that pain is a “thing” that is “processed”, that the involvement of the central nervous system in “centralized” pain is somehow different from other types of pain, and that this is a “lifelong disorder”.

A much less popular view is that fibromyalgia is an arbitrarily defined disorder constructed by physicians to encompass a spectrum of symptoms of distress commonly present in the general community. Fibromyalgia sits at the severe end of this spectrum, but there is no clear line of demarcation that determines what it is or is not [Wolfe 2017].


Even more interesting I find Quintner's further details about the problems with central sensitization and the concept of nociplastic pain: Apparently first talk of nociplastic came up when the definition of normal pain, nociceptive was narrowed down to pain with damage, so fibro no longer fitted into it, because no damage is detectable (in my thinking it is only seemingly so, it can't be detected yet). So the IASP assembled a task force that came up with
“nociplastic” for pain without damage [Kosek et al. 2016], neither (ii) nociceptive nor (iii) neuropathic.
The intention of “nociplastic” was to serve as a clinical placeholder that identifies presumed altered central nociceptive function to account for the pain and, importantly, the allodynia experienced by such patients, as a prelude both to developing validated criteria for its identification and to focussing research into its mechanism(s).
However, the authors together with Wolfe believe that the term has been hijacked to make sure "as many pain sufferers as possible will continue to be recruited into the Fibromyalgia diagnosis [Wolfe 2017]", they claim partly because pharmaceutical companies with their sponsoring and grants have an interest. [That is something too contentious for me.]

I haven't understood all - even most - of the following yet, so I'm quoting, highlighting the seemingly most important bits, and may delve into it later, maybe someone can help:

"As an example of highjacking, Kosek et al. [2021] suggest that a patient’s pain can probably be denoted as “nociplastic” when there is a history of “pain hypersensitivity” and one or more comorbidities. But because people cannot be (hyper-) sensitive to their own pain the term “pain hypersensitivity” is illogical. Furthermore, their suggested list of comorbidities is indistinguishable from the symptom cluster of fibromyalgia. A somatic descriptor of pain must be defined only in terms of nociceptive function and may not be identifiable clinically by features that are not directly related to nociceptive function.
In a similar example Nijs et al. [2021] confidently promoted “central sensitization” as the main underlying mechanism of “nociplastic pain”, without justification. Furthermore, throughout their paper these authors ignored the IASP definition of “central sensitization” and linked it with various non-pain symptoms. In this way they asserted that pain conditions that attracted neither nociceptive nor neuropathic descriptors were nociplastic by default. Both interpretations are contrary to the letter and intent of “nociplastic”.
Conclusion
“Nociplastic pain”, “central sensitization” and the symptom cluster of “fibromyalgia” are not synonymous concepts. Those who have highjacked “nociplastic” away from being a pain descriptor appear to have a vested interest in preserving the taxonomic primacy of “fibromyalgia” in clinical rheumatology, despite the fact that the term is a misnomer, as the “-algia” does not originate in the “fibromy-” tissues."


What I get about research is
- both "nociplastic" and "central sensitization" are used too often, ignoring the original meaning.
- "central sensitization" is not necessarily the mechanism of "nociplastic pain". That I didn't realize, and don't, fully.
- "pain hypersensitivity" is a difficult term in itself - yep, good one, altho I haven't quite understood it yet...
- "nociplastic pain" was actually meant as a "placeholder" term, that's what I've always been saying, same as
- "nociplastic pain" is meant to describe allodynia - so the term only may become helpful for people with that.
 
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Hi @JayCS

Quite a read ! Not done yet, might take a couple of reads. ;)

I did a pain management course a while back, and I am intrigued to think there is a tie between 'learned pain' and fibro. I am thinking along the lines of, somewhere in the sub-sub-conscious, the area that controls breathing and heart etc., (don't know technical term) that the brain has 'learnt' something, or 'thinks it learnt something' and throws 'feedback' (pain) when it isn't actually 'there'.
 
The fmperplex blog has a wealth of articles by Wolfe and in his vein, with references and comments below, e.g.
2023 Reflections About Pain, 2023 What is at the hub of "pain revolution"?
2021 Diagnosing Fibromyalgia, 2021 Fibromyalgia and the Social Construction of Organized Distress.
2020 The misnomer of pain sensitivity. 2020 "Tame the Beast"; does this metaphor really work?
2020 Why pain cannot be learned and unlearned
2019 Fibromyalgia and neuroinflammation: Shall the twain ever meet?
2019 Is chronic pain really a disease?
2019 I can't define it, but I know it when I see it [fibromyalgia is meant, and the title is irony],
2019 Intersubjectivity in Clinical Encounters,
2019 Pain cannot be a conditioned response!

The last one in bold type caught my attention and brings me back to the thread title, cos of an earlier "FM test".

The title is ironic: "Fibromyalgia — well, I know it when I see it is how physicians and patients tend to define it. Good enough? Maybe not."
"For conventional disorders, criteria are used to diagnose disease. But fibromyalgia criteria define disease (or disorder or condition or whatever you want to call it)."

Then he slags off that 2018 test called "IsolateFibromyalgia" (not sure why he calls it a 2nd blood test:
"Readers may know that there is a second “blood test” for fibromyalgia. In 2018, “a Tennessee laboratory … launched an innovative new blood test that uses RNA analysis to diagnose patients with fibromyalgia. IQuityLabs says its test – called IsolateFibromyalgia – can identify fibromyalgia within a week and with over 90 percent accuracy. The test costs $599.” While conventional criteria have their problems, by definition they have to be better than any blood test because they are the standard that any blood test would require for calibration. Potential testees could save themselves [their insurance company or government] $599 by downloading the fibromyalgia criteria diagnostic questionnaire – widely available on the Internet for $0.00. Actually, according the blood test blurb, the test was developed from “diagnosed” patients. Oops, be sure to read the articles on misdiagnosis when they are published next month.
The central problem in fibromyalgia is the necessity of dichotomizing a continuous measure of pain and associated symptom distress into disease/non-disease (FM/not FM). If instead we measured these symptoms, as with the polysymptomatic distress scale (PSD) of the modified ACR fibromyalgia criteria, we could better understand fibromyalgia symptoms without forcing people into artificial dichotomies. People could improve or have lower levels of symptoms without gaining or losing a diagnosis. As an analogy, rather than comparing “healthy controls” with the “obese,” why not measure body mass index (BMI) — or perhaps you would prefer a $599 blood test?"
 
a tie between 'learned pain' and fibro
Then the 2020 article by Quintner and Griffith "Why pain cannot be learned and unlearned" will be something for you, whether you agree or disagree.
The crucial text part seems to be:
"Among the strategies discussed by Cordier & Diers [2018] are “cognitive extinction training” and “cognitive behavioural training”, procedures that have shown promising results in the modification of the behaviours of those experiencing chronic pain. However this does not apply to the sensation of pain itself."
after saying:
"There is evidence that pain perception and pain behaviours can be learned through conditioning, but none at all to suggest that pain itself (the sensation) can be learned."

I think that's an important distinction which takes our pain seriously with no false promises. You too?
 
"There is evidence that pain perception and pain behaviours can be learned through conditioning, but none at all to suggest that pain itself (the sensation) can be learned."

I think that's an important distinction which takes our pain seriously with no false promises. You too?
@JayCS

I think, considering that there are people born with no sense of pain, it would confirm that pain cannot be learned.

Bit late for me, just after midnight. I'll get back to this in the next few days. (head permitting lol ).

Thanks for the lively thread ;)
 
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