In December 2012 ‘Unique immunologic patterns in fibromyalgia’ was published as Behm et al. BMC Clinical Pathology 2012, 12:25 http://www.biomedcentral.com/1472-6890/12/25. The authors measured cytokine levels in the blood of 201 subjects (110 with fibromyalgia). They concluded ‘The cytokine responses to mitogenic activators of PBMC isolated from patients with FM were significantly lower than those of healthy individuals, implying that cell-mediated immunity is impaired in FM patients. This novel cytokine assay reveals unique and valuable immunologic traits, which, when combined with clinical patterns [italics mine], can offer a diagnostic methodology in FM.’
In April 2012 a company called EpicGenetics filed a patent for ‘A method of diagnosing and treating fibromyalgia.’ (http://patentscope.wipo.int/search/en/WO2012051317) They wrote:
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.
In March 2013, EpicGenetics started selling the ‘test’ for $744 to physicians and directly to patients (http://thefmtest.com/about-the-fm-test/). This test is unlikely to be reimbursed by insurance companies. In the BMC Pathology paper they `declared that they have no competing interests.’ Either they forget to tell the reviewers they were about to market the ‘test’ or they concealed it. There was a lot of money involved for the company and Dr. Gillis, and it is almost certain that the reviewers would have taken note of this fact. If the authors just ‘forgot’ and asserted no conflict, they still had a lot of time to correct the error and to tell the journal.
Cytokine levels are abnormal in many physical and mental conditions. The authors studied none of those conditions. They provided almost no information about patient selection or many other vital data for a comparison trial. The CONSORT statement on publishing trials offers guidelines on the reporting of data. They didn’t follow these guidelines. As a clinical study, it was very poorly planned and carried out. As a pathology report it might pass. But the data did not in any way addresses the validity and reliability of their ‘test’ to diagnose fibromyalgia. I conclude that they (EpicGenetics and Dr. Gillis) were trying to fool people into buying the scientifically unproven $744 test.
For such an ethical violation, BMC Pathology should withdraw the paper. Want to diagnose fibromyalgia? Talk to the patient. In less time than it takes to get the blood drawn you can have the diagnosis (free!).