This is a new short article on medpage yesterday, based on a very long and informative STAT investigation article from last week (2021/10/20). The links and my comments (sorry, lengthy...) below...
"Bogus Fibromyalgia Test?
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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medpage article: medpagetoday.com/special-re....
The STAT investigation article it is based on, by Eric Boodman, Oct. 20, 2021. statnews.com/2021/10/20/sel...
Interesting quotes from this, left out in the article above:
"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 $580,000, with more to follow if the project got regulatory approval. But then, after regulatory approval came through late in the summer of 2018, the next payment never arrived. .... Neither Gillis nor the hospital would say how much money he’d given by then. When Faustman contacted him to inquire about the late payments, the hospital said, he gave different responses: First, he was waiting to hear about other business transactions; then, he explained that his focus had shifted away from BCG. She kept in touch, hoping it might shift back.
About the 2015 study: But 31% of those with arthritis and 29% of those with lupus also tested positive for fibro. People can have two of these ailments at once — but the researchers had explicitly tried to exclude anyone with that sort of double-diagnosis.
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My comments and further links:
Pity for all those waiting with high hopes to take part in the trial. But "great" to see the doubts many people incl. me were having about Gillis and the FM/a test out in the open, spoken out, and his delay/ing tactics exposed. Of course some of us are exasperated by the vagueness of this invisible pain and desiring at least a test and even a cure, both of which Gillis has been claiming to provide... and it's hard to see hopes dashed, slim as they might've been. The "cure" he was targeting at in the clinical trial at MGH, Mass General Hospital, isn't mentioned here, but for those who don't know: he was wanting to test an adaptation of an old BCG vaccine (Bacillus Calmette-Guerin, the Tokyo species). Solely based on the fact that it might have helped improve type1 diabetes and MS, based on trials also done at MGH.
Also not mentioned is that what he means by insisting he's doing what's best for us is that he wanted to attempt an artful shortcut by using some of many possible but not proven biomarkers (cytokines and chemokines) to earn a lot of money (>1000$ 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: healthrising.org/blog/2019/.... 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 site](fmtest.com/about-fma/), 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$ (fibromyalgiaresources.com/v... 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 (themighty.com/2018/09/fibro... has quite a few strange, but also interesting comments.
An Immune Disease? Low Dose Naltrexone (LDN) Fibromyalgia Study Suggests FM Has Inflammatory Side
FM symptoms
Do you know what triggered your fm?
New information on Fibromyalgia - guys just found this - very interesting reading
Migraine on FM
