On 11th March I posted about there being a Blood Test available in the USA that claims to diagnose Fibromyalgia. I hope that one of the things that came across in that post was my level of “healthy scepticism” and although I am not medically qualified I could see a few warning signs that the Blood Test might not be all it claims to be. Since I have been able to research this story more (as I am sure many of you have done) I soon found evidence that backed up my scepticism.

The background to this story first appeared in a study titled “Unique immunologic patterns in fibromyalgia” published on BMC Clinical Pathology (A publisher of peer-reviewed Science, Technology and Medicine journals) website by Dr. Bruce Gillis. The study claimed that “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, can offer a diagnostic methodology in FM.”

So it appears the study suggests that “cytokine” levels could be tested and that this test could offer a method of diagnosing Fibromyalgia. Following this many people expected that this could kick start research into “cytokine” and that it may offer a glimmer of hope for Fibromyalgia patients in years to come. But what happened only a few months later was that a company called EpicGenetics in the United States started to offer a commercially available Diagnostic blood test for Fibromyalgia. The test was called the FM/a® test for a fee of $744.

Now going back it appears as though the author of the Study published by BMC Dr. Bruce Gillis is also the founder of the company EpicGenetics according to this article entitled Questions arise over new diagnostic test for fibromyalgia by Fox News and also shown on a company biography here. So here we have a potential commercial motive here for this study and diagnostic test although it is worth saying that this is common practice and isn’t in itself evidence of something more sinister. This said a diagnostic test for Fibromyalgia could be very profitable for a company given the fact diagnosis is currently one of exclusion in that a patient presenting with symptoms will receive various tests for other medical problems and when they all come back negative a diagnosis of Fibromyalgia is then considered. Also patients diagnosed with Fibromyalgia quickly learn that some people do not believe in the condition itself and with a lack of physically visible symptoms they find their condition hard to prove to anyone, friends, family, employers and even medical professionals alike. So it is no surprise to find that in the first month EpicGenetics took three quarters of a million dollars ($750,000) in payment for tests in their first month giving the lab approximately 1,000 tests to process.

One of the most vocal criticisms comes from Professor Fred Wolfe (Director of National Databank for Rheumatic Disease in the USA) in his blog post entitled “Junk Science – Junk Ethics.” He states that “Cytokine levels are abnormal in many physical and mental conditions” and concludes in saying “that they (EpicGenetics and Dr. Gillis) were trying to fool people into buying the scientifically unproven $744 test.” This criticism has been quoted in several articles written on the Internet and quite frankly plenty of criticism is available if you start looking into the test online. That said people rarely research these things and often assume that if a medical company offers a test it must have had all the appropriate testing needed and that it is backed up with sound medical science.

So it appears as though this test might not be as great as it appears to be. It seems to have come about from a single medical study conducted by the people profiting from the money the test makes and there are many questions about it that remain unanswered. The study fails to address some rather big issues like;

What other conditions display the same result?
What exactly is the mechanism behind these cytokine levels?
As test patients had a diagnosis of Fibromyalgia for over a year how do cytokine levels change in early and late stage patients?
How many independent Studdies should there before a diagnostic test is marketed?
Is there anyone responsible for regulating this area of medicine and diagnostic tests offered by companies to the public?

So I’m afraid it isn’t all its cracked up to be. Personally I would advise against the $744 fee for a very questionable diagnosis and before you do, consult your doctor or specialist first. It is hard to believe a diagnostic test can be offered as a result of a study performed on 201 patients funded by the company payment for a test goes to. It reminds me of the small print on television shampoo adverts when they say “90%” of people loved this shampoo but on the bottom of the screen in very small writing you read “out of 10 people asked.” But the shocking thing is the Shampoo industry may be better regulated.

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