A concern arose after an American biomedical company, EpicGenetic’s, announced an offer to provide “patients and their families with a conclusive answer in their search for a fibromyalgia diagnosis,” through what’s known as The FM Test. However it has been revealed that the research behind The FM Test, not only appears to be inconclusive, but also EpicGenetic’s seemed to have strong influences with the reasearch conducted.
“The authors have addressed most of the reviewer`s questions, however, the reviewer still has some major concerns. This study investigates serum samples of FMS patients using one single method and claims to have found the “unique pattern” of cytokines in FMS patients. This title is misleading and not well based by the data shown and the methodology used. A second method is obligatory especially when investigating such a “fragile system” as cytokines that may be influenced by many factors and when investigating a non-well defined condition such as FMS with an inhomogenous patient cohort – even when using the ACR criteria. Otherwise this study will merely add another one to the large body of literature on cytokines in FMS, but of unclear significance.”
What you have just read is the considered opinion of one of the independent expert reviewers of a paper (“Unique immunologic patterns in Fibromyalgia”) that was subsequently published in the December 2012 issue of BMC Clinical Pathology, an on-line medical journal.
In the light of this reviewer’s comments, one might have expected the authors of the paper (Behm et al.) to have been exceedingly cautious about drawing any conclusions from their research. In fact the opposite has been the case!
The company that appears to have funded the study – EpicGenetics, Inc., a privately-held biomedical company based in Santa Monica, California – announced on its website that “FM/a® , The FM Test , now offers patients and their families a conclusive answer in their search for a fibromyalgia diagnosis.”
The authors of the paper declared that they had no competing interests. In point of fact, Dr Bruce Gillis, an occupational physician and corresponding author, failed to disclose to readers of the paper that he had founded EpicGenetics in 2010.
The company filed a patent for ‘A method of diagnosing and treating fibromyalgia’ in October 2011. In their own words: The invention provides methods, kits and reagents for diagnosing fibromyalgia (FM) in an individual by determining whether the levels of one or more cytokines in the individual are altered, as compared to control levels. The altered level(s) or patterns of expression of the cytokines measured in the affected individual compared to the level from the control is predictive/indicative of FM in the individual.
On its website, EpicGenetics featured a photograph (borrowed from his website and since removed) of leading Fibromyalgia Researcher Professor Daniel Wallace and accompanying comments (without first clearing them with him) that were favourable to the test to bolster their claim that The FM Test can confirm a clinical diagnosis of Fibromyalgia with a sensitivity of 93% or more. The total cost of the test is US$744.
Professor Wallace, Clinical Professor of Medicine at the David Geffen School of Medicine at UCLA, who knew nothing about this research until December 2012, is listed as a member of EpicGenetic’s prestigious Scientific Advisory Board. He believes that “the test is a good measurement for chronic stress in patients with chronic sensitivity syndromes” and that “less than 1% with FM would have any use for such testing.”
By contrast, Professor Fred Wolfe, in his blog Fibromyalgia Perplex considers that the results of the study do not support the claim that they are diagnostic for Fibromyalgia. He is also highly critical of way in which they have been harnessed to a vigorous marketing strategy cleverly designed to appeal to the many Fibromyalgia patients around the world who repeatedly complain that doubt is cast upon their credibility as valid witnesses of their own pain.
Professor Wolfe raises many other issues about the “test” that are of concern to him. These are of sufficient importance for him to have requested the journal editor(s) to withdraw the paper!
As for the patients, perhaps the best advice one could give them is to heed the ancient maxim Caveat emptor (let the buyer beware)!
By John Quintner, Physician in Rheumatology and Pain Medicine, Honorary Medical Editor, Arthritis Today WA
Please note: The information contained in this article has been carefully checked and any opinions expressed therein are solely those of the author and not necessarily those of Arthritis & Osteoporosis WA.