"The program’s on hold, he knows it’s on hold, so that’s a little bizarre…"
This is the website. And this is the very interesting long STAT investigation article, “Selling Certainty” it is based on (by Eric Boodman, Oct. 20, 2021). Some of the most interesting quotes from this, left out 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 $580,000, with more to follow if the project got regulatory approval. But then, after regulatory approval came through late in the summer of 2018, the next payment never arrived. Neither Gillis nor the hospital would say how much money he’d given by then. When Faustman contacted him to inquire about the late payments, the hospital said, he gave different responses: First, he was waiting to hear about other business transactions; then, he explained that his focus had shifted away from BCG. She kept in touch, hoping it might shift back.
About the 2015 study: But 31% of those with arthritis and 29% of those with lupus also tested positive for fibro. People can have two of these ailments at once — but the researchers had explicitly tried to exclude anyone with that sort of double-diagnosis.
Click for: My comments
Thank you for pinning this! - And: Pity for all those waiting with high hopes to take part in the trial. But “great” to see the doubts many people incl. me were having about Gillis and the FM/a test out in the open, spoken out, and his delay/ing tactics exposed. Of course some of us are exasperated by the vagueness of this invisible pain and desiring at least a test and even a cure, both of which Gillis has been claiming to provide… and it’s hard to see hopes dashed, slim as they might’ve been. The “cure” he was targeting at in the clinical trial at MGH, Mass General Hospital, isn’t mentioned here, but for those who don’t know: he was wanting to test an adaptation of an old BCG vaccine (Bacillus Calmette-Guerin, the Tokyo species). Solely based on the fact that it might have helped improve type1 diabetes and MS, based on trials also done at MGH.
Also not mentioned is that what he means by insisting he’s doing what’s best for us is that he wanted to attempt an artful shortcut by using some of many possible but not proven biomarkers (cytokines and chemokines) to earn a lot of money (>1000$ is the price since last year) to be able to afford to run a study on a hopeful cure (this is not my phrasing, 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…, see my cause/trigger reference list.) 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.
Click for: What I find strangest about the FM/a test and the BCG vaccine...
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, 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. This study about cost-effectiveness talks about 14$-180$, praps depending on the country. So Gillis offering this jab “at no cost” for all those who have done his 1000$-test seems a bad joke. Especially as he is not offering it to those who have been turned down despite having got a positive test result. And it should be easy to get and cheap to pay for…
Who needs the test anyway?: And wdnt our quickest shortcut’ve been to just try his BCG vaccine ourselves? And if anyone is wary about getting the jab done, why are they keen on getting it done by him? It could of course cause problems by stimulating the immune system too much… but that risk would be there whether MGH or a local GP did it.
Click for: Will US-insurances continue to pay for it?
I’d be interested if Medicare and other insurance will still pay for the FM/a test after this kind of press coverage, they have in the past. But if people get a positive result (which strangely all do that I’ve heard of…) they will tend to stop getting all of their symptoms checked up and just blame everything on the fibro, which will come a lot cheaper than the 1000$…
Click for: Link to the yearly FM-study-review
(BTW there have been yearly Spanish reviews summing up all the research, since 2015 (except 2017) like this one for 2020 (they call it one year forward: “2021”).)
Click for: Older comments on The Mighty on this I found interesting
(The page about the test on The Mighty.com has quite a few strange comments: Many people there are asking on that site to take part in the trial; many others are doubting that they won’t be able to take the test in their part of the world; and “Susan Schroeder” has used the argument “With so many fibro mimics out there it gave me some peace of mind about it really being fibromyalgia.” What?! But then there’s interesting comments: “trasea " says “vaccines and pharmaceuticals are poison” which isn’t such a wrong idea. The Purple Unicorn says “I had the BCG vaccination” … I still have M.E., fibromyalgia and osteoarthritis” … whilst it is answered with “The effects of the tb vaccine you had as a child have long since become ineffective.” Robbie says “I had the blood test and it didn’t show me as more than 30% positive for Fibromyalgia. Now I feel let down all over again.” Mollie asks “I don’t understand, I have to pay for this trial?” Clair asks “By the time you are an adult it is advised you do not have the bcg due to side effects. I wonder how many strains of these medicines there are?” Brenda Caldwell says “Sounds like you may only be [eligible] for the initial test to see if you are a candidate. If no match, I guess that kinda voids their logic/theory. All BS? More than 1 cause?” Many comments are saying that it is not an inflammatory or autoimmune or immune system disease according to their knowledge and feeling about their symptoms, e.g. Sandy Miller: “Personally I think there is more to Fibro that immune system dysfunction, unless our immune systems can screw around with our central nervous systems.” Nicole C says “f they truly want people to participate, why not have people show their confirmed diagnosis and then have EpicGenetics cover the cost of the test for confirmation? Otherwise, this trial is only being offered to people who can afford to drop a grand for a CHANCE at the trial. No thanks.” Terri Walker “I’d prefer to see treatment with IV-MG. There has already been proven success for those of us with both fibro and small fiber neuropathy.”…
Anyone ever tried the BCG vaccine for fibro?! While unsuccessfully re-searching if anyone has ever done so ... the end of Andersen's tale of the Emperor's new clothes occurred to me...
The Emperor walked under his high canopy in the midst of the procession, through the streets of his capital. All the people standing by, and those at the windows, cried out, “Oh! How beautiful are our Emperor’s new clothes! What a magnificent train there is to the mantle; and how gracefully the scarf hangs!” No one would admit these much admired clothes could not be seen because, in doing so, he would have been saying he was either a simpleton or unfit for his job.
“But the Emperor has nothing at all on!” said a little child. “Listen to the voice of the child!” exclaimed his father. What the child had said was whispered from one to another. “But he has nothing at all on!” at last cried out all the people. The Emperor was upset, for he knew that the people were right. However, he thought the procession must go on now! The lords of the bedchamber took greater pains than ever, to appear holding up a train, although, in reality, there was no train to hold, and the Emperor walked on in his underwear.
It'd've been 3! BCG vaccinations spaced 1 year apart!
Just found an open tab I hadn’t read thru yet, on the “Phase II Clinical Trial: Multi-dosing the BCG Vaccine for Fibromyalgia” (clinicaltrials.gov).
I don’t get why Faustman estimated the end to be Jan 1, 2023 (defined as last date a patient is seen): if the last patient’dve been vacced let’s say Jun 15 2022 for the first time, then surely the patient end’d be Jun 15 2024 and the complete study’dve been published end of 2024, I’dve thought…
Estimated Study Start Date : January 1, 2022
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2023.
(“Recruitment Status : Suspended (No funding at the current time.)” since May 27 2021; before that “Not yet recruiting” since Jan 27 2021)
a) the idea was solely based on a hunch by Gillis, who is an entrepreneur, not a doctor,
b) his site stated he had enough funding from the FM/a test,
c) the researcher said Gillis had given the idea up,
d) he hadn’t told her that he was still using the trial as a carrot for selling the FM/a test.