Blood Test for Fibromyalgia: FM/a Test ® Is Real, Q&A

A blood test for fibromyalgia is available that you, or your doctor, may not know about. It is the FM/a® test.                                                       

Following is information on insurance, criticism, realities, and research. Dr. Bruce Gillis, MD, MPH, founder and CEO of EpicGenetics and I consulted, so you can have the best information.

Insurance

Many insurance carriers, including Blue Shield of California and Medicare are now reimbursing for the FM/a® blood test. The following explanation is for you and your provider. 

1.       Go to https://fmtest.com/ and click the “Getting the Test” button.

2.      This takes you to the "I’d Like to Order FM/a®” page. Here you will find,  "Can you answer YES to experiencing or having recently experienced several common fibromyalgia symptoms, including: chronic fatigue, many painful or tender areas, mental/brain fogginess, poor sleep, trouble concentrating, frequent headaches, joint aches, leg cramps, restless legs when you sleep, anxiety/nervousness, feeling depressed, numbness or tingling?"

*You must be able to answer YES to at least four of the symptoms to be eligible.

3.     Next is the online form that asks for relevant data, including contact and insurance information; information needed for the authorization and order processing.

4.     After completing the first three steps, you will receive an email confirmation. This begins the insurance review and statement of coverage.

5.     A link to a “Physician Authorization Form”, and instructions for your doctor on how to fax paperwork will also be sent to your email.

6.     The FM/a® test kit is sent to your doctor for a simple blood draw. The kit includes an overnight shipping package and instructions for returning blood samples to the CLIA-certified and CAP Accredited laboratory in Los Angeles. 

7.     Results take 7 to 10 days.

*If you don’t have insurance, EpicGenetics offers a zero percent interest, six-month payment plan.

Dr Gillis Is Dedicated

Dr. Gillis has personally spoken with many people who have questions about the diagnosis, available treatments, how to work with doctors, spouses, family members, etc. He says he feels a personal obligation to be available because he and his co-researchers at the University of Illinois, College of Medicine were the first to legitimize fibromyalgia with a confirmable diagnostic test.

He appreciates advocates and patients willing to help build a database that will lead researchers to explore immune system pathways, potential DNA/RNA gene markers, and the development of medications and other treatments that target the cause rather than mask symptoms.

Why Are More Physicians Ordering the FM/a® Test?

Dr. Gillis says there has been a significant increase in tests ordered. He believes this is because there is greater acceptance by physicians. They are moving away from “rule-out” tests because the FM/a® test gives a direct, “rule-in”, rapid, accurate and cost-effective diagnosis. Because more people are aware and more insurance companies are paying for the test, we (people living with fibromyalgia) are asking our doctors to order it too. It is affirming to know there is a biomarker— a biological test—that confirms our symptoms.

My rheumatologist is willing to order it for me. And, now I have the information I need to get the ball rolling in time for my next appointment. I hope you can do the same.

https://fmtest.com/

Questions, Answers, and Opinions

A recent article in Fibromyalgia News Today came to me via Google Health News, Proprietary FM/a Fibromyalgia Blood Test Claims Quick, High Accuracy Results. When I shared it, I received some valid questions. Following I address the questions, and share my thoughts.

Questions

“What if you've got all the symptoms of fibro, you've had all the testing to rule out everything else, you've been treated for fibro for years, you have the test, and it says you do not have the markers? Will you be told it's all in your head and be taken off all of your meds? Can the test truly be trusted?”

My Opinion

I have asked myself these questions and reasonable deduction tells me that if my test is negative, it is possible that other chronic pain has become centralized, causing changes in my brain that leads to body-wide tenderness. (There is ongoing research on this.) However, no test is 100% accurate. In fact, if someone says it is, question the validity.

The FM/a® test research, Unique ImmunologicPatterns in Fibromyalgia, found the biomarker in 93% of study participants. So, if there is reason to suspect a false negative, one might consider testing for loss of heart rate variability (HRV), which has also been suggested as a potential biomarker.  Kenny, MJ and Ganta, CK (2014) state, “Further understanding of regulatory mechanisms linking the sympathetic nervous, parasympathetic nervous, and immune systems is critical for understanding relationships between chronic disease development and immune-associated changes in autonomic nervous system function.”  Another reason the FM/a® test is so important.

It is possible to be misdiagnosed. Knowing what it isn’t could lead to the right tests and treatments for a disease that has been mistakenly attributed to fibromyalgia.

Particularly Interesting

Dr. Gillis tells me that in the first four years since the FM/a® test has become available, “the only suspected false negative test results occurred in patients who failed to stop taking their immune system blocking drugs”.

Can the Test Be Trusted?

In late 2012, The FM/a® test was awarded for “Outstanding Research in Clinical and Diagnostic Immunology” by the American Association for Clinical Chemistry. And both the initial and follow up studies were conducted at the University of Illinois at Chicago, College of Medicine, which ranks #11 for 2016 | Best Medical Schools: Research Rankings Methodology. Both studies have been published in peer-reviewed journals.

The different results on cytokines (inflammatory immune protein molecules) compared to other studies could be due to the methods used (i.e. ELISA vs. the multi-biomarker based FM/a® test, which assesses cytokines and chemokines from blood mononuclear cells). The American College of Rheumatology suggests that FM occurs more frequently in immune rheumatic disorders and we know ME/CFS, interstitial cystitis and other disorders with suspected immune dysfunction overlap. So, differences in other studies could be due to subjects who are misdiagnosed with FM, something the FM/a® test will guard against.

The follow up study for specificity to FM,  Cytokine and Chemokine Profiles in Fibromyalgia,Rheumatoid Arthritis and Systemic Lupus Erythematosus,  compared other rheumatic conditions and found it to be specific to fibromyalgia, further solidifying the validity of the blood test. 

Some, whose research is funded by pharmaceutical companies, criticize Dr. Gillis’ because he is the founder and CEO of the lab that does the FM/a® test. But, I have this to say. The FM/a® blood test is performed using a unique multiplex immunoassay. Because of the complexity, just like certain skin biopsies or DNA, it must be analyzed by a specific lab that is specially equipped. Remember, specialized labs were once used to detect HIV and now we are now looking at a vaccination, and the potential to wipe AIDS off the map. Specialized laboratories, such as EpicGenetics, are necessary to accommodate developing science.

It is also apparent that insurance companies and Medicare believe the test is valid. As more tests are ordered, it will maximize the lab’s resources and drive cost down, and just like the HIV test, we can expect the FM/a® test to receive the recognition it deserves.

Why Is Research Important?

I hope every study participant from here on has this test, because it will change the landscape of fibromyalgia. Overlapping symptoms with other disorders can be exclusively ruled out. This is important because the approved FM drugs (antidepressants and anticonvulsants) do not treat immune disease directly. After extensive literature review over the past two decades, I have seen a recurring trend, a disruption in the systems that affect immune response. Sure, there are many who do not have time to keep up with ALL the research. And, there are those who tell us fibromyalgia is psychosomatic (in my opinion due to 2010-2011 ill-conceived, unapproved diagnostic criteria), but remember multiple sclerosis was once known as hysterical paralysis until technology caught up to the patient. 

In 2015, a second study on the cerebral spinal fluid of ME/CFS patients found significant reductions in the concentration of cytokine IL-10, which is in contrast to a previous study. Peterson D, et al., state the difference “may be due to the heterogeneity of the disease, different analytical methods, and the presence of divergent patient subgroups”.  This further corroborates my personal opinions expressed here.

Because of the FM/a® test, Dr. Gillis can collect information that is just as important as empirical studies. The data will spirit life into important research, resurrect research previously conducted, and lead to more funding for replicated studies. Some research of recent years has gone off course, wasting precious financial resources for a disorder that was first documented by British surgeon William Balfour in 1816 (discussed in the history of fibromyalgia in our book). 

Helping collect data through the FM/a® test is one way we can participate as change agents for the future of fibromyalgia. The only way is forward.

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I am not affiliated with EpicGenetics, nor have I received any pay for this article.

You might also be interested in reading Cort Johnson’s article regarding the FM/a®test at Health Rising.

In healing,

Celeste Cooper, RN / Author, Freelancer, Advocate

Think adversity?-See opportunity!

http://www.CelesteCooper.com

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Learn more about Celeste’s books here. Subscribe to posts by using the information in the upper right hand corner or use the share buttons to share with others. 

Chronic Pain: NPS and the CDC Guidelines Trending on Social Media

Chronic pain topics trending on social media have increased with the release of the National Pain Strategy (NPS) and the CDC Guidelines for Prescribing Opioids. Having submitted comments on both drafts, I felt it was time to express my personal opinions. There are vast differences between the two, even though the “CDC Guidelines” are specifically mentioned at the conclusion of the NPS report.

CDC Opioid Checklist: The good, the bad, and the ugly 

Overall, the checklist is not difficult to understand and physicians will be more likely to use it. Where I do not comment, assume it to mean I don’t see any reason to mention it.

Good Stuff:

·        “For primary care providers treating adults.” - Primary care physicians need guidelines by government agencies so they do not fear retaliation by the DEA. Not all patients living with persistent pain require supervision by a pain specialist; in fact, there aren’t enough pain physicians to meet the needs of over 100 million Americans living with chronic pain.

·        “Known risk factors” – Important assessment.

·        “Prescription drug monitoring program”  (eleven states do not have a PDMP) – You can read what I think about medication safety on my website. PDMPs are good for identifying signs of drug diversion or abuse, which protects responsible people, but will physicians who treat patients with conditions that cause chronic pain, i.e., pain physicians or rheumatologists be singled out? And, how will this affect patient care in states without a PDMP?

·        “Behavioral treatment” – This piece is often difficult for physicians to discuss with their patient’s, and vice versa. However, there is evidence that shows our behavioral response to pain makes a difference in our ability to cope with the fall of of living with chronic pain, and how we respond to it mentally and emotionally can affect our pain intensity. (This does not mean it treats the pain source directly, however.)

·         “Schedule initial reassessment within 1– 4 weeks.” – This should be done any time a new medication is started, including non-opioids that affect the central nervous system.

·        “Assessing pain and function using PEG scale” – This one gets a mixed review. Relieving pain, decreasing the intensity to improve quality of life is the reason we seek pain care. However, quality of life should be assessed according to what that means for each individual patient. For instance, a diseased spine or joint is not going to function better despite pain relief. Q1 is difficult because it relates to an acute pain scale, which is not helpful for assessing chronic pain, especially in a person with more than one pain condition. Q2 reverts back to my comments on changing behaviors. Enjoyment of life is not affected by opioids, it is affected by developing healthy coping skills as is the truth for any chronic illness. Enjoyment of life fluctuates for everyone.  Q3 Improving endurance, i.e. activity, cannot be achieved without therapies that are often capped by Medicare and is not based on patient outcome. And, easing pain will not necessarily result in increased activity. Overall, asking a patient to make their own assessments is important, but placing an arbitrary number (30% improvement) is punitive. Many factors, life situations, can cause the numbers to fluctuate. One cannot assume status quo for chronic pain anymore than they can assume blood sugars will remain constant in treatment of diabetes.

Bad Stuff

·        “Benefits of long-term opioid therapy for chronic pain not well supported by evidence.” – Describe evidence? Anecdotal reports from physicians who specialize in pain medicine are evidence (but they were not represented in the “Core Group” of experts). If they are referring to research, there is no evidence to suggest opioids don’t work for long-term pain care.

·        “Schedule reassessment at regular intervals (≤ 3 months)” – This guideline is not appropriate for patients who do not need advanced pain care. Patients who have been on the same opioid dose for years do not require such close observation. Many patients, particularly the elderly, do not have the ability to see the doctor this frequently, nor is the physician available. To put an absolute time interval (without cause) puts an unnecessary burden on the physician, patient, and insurance, including Medicare, and drives up healthcare costs. This is a total disregard for common sense.

·        “Urine drug screens.” I am not against them when there are signs of abuse. (Perhaps the checklist should include assessment of those behaviors.) However, using drug screens to assess risk without probable cause is offensive for several reasons: they are accusatory (guiltily until proven innocent), they are humiliating, they are not consistently accurate, and they are not always covered by insurance, which is discriminatory against folks who can’t pay. Innocent people are being tortured by inaccurate results, while drug testing companies are making a killing, sometimes literally.

The Ugly

·        “NON-OPIOID THERAPIES Use alone or combined with opioids, as indicated:” – Suggesting long-term use of NSAIDs is not safe, and there is evidence to suggest this. Antidepressantsare not without consequences; they have many drug-to-drug interactions and can lead to suicidal thoughts, they are not always a safer choice. Anticonvulsantsare also abused because of euphoric effects and can have serious side effects like antidepressants. Non-opioid treatments should be considered, but the effects of alternate drugs should not be undermined.

·        “Calculate opioid dosage morphine milligram equivalent (MME).” Every patient is different. It is common sense to taper any drug or treatment to effect, but this particular issue could put a prescribing physician at risk of litigation.  (See Dr. Fudin's opinions.)

The National Pain Strategy (NPS)

“National Pain Strategy outlines actions for improving pain care in America

Plan seeks to reduce the burden and prevalence of pain and 

to improve the treatment of pain”

There are many things I agree with, some that I can tolerate, and others that I felt needed attention. The NPS did have representation by advocates during its draft, and we have all been waiting for it to be released. And, so it has been. You can see and overview and download the National Pain Strategy here.   

“The Strategy provides opportunities for reducing the need for and over-reliance on prescription opioid medications;” this statement disturbs me. I believe the only way we can reduce the need for pain relief is to find a cure for scleroderma, complex regional pain syndrome, the effects of aging on the body, arthritis, fibromyalgia, EDS, myofascial pain syndrome, the centralization of pain, etc. Relieving pain is instinctive to all animals, including humans.

Not including all the stakeholders in the drafting of the CDC guidelines has many advocates and advocacy groups incensed, and rightly so. Public notice of the guidelines was made public for only 3 days. Only after being caught, did they allow our voice. But, despite pleas made by people far better equipped and knowledgeable (and unlike me, able to retain what they read), the CDC published them anyway. The total disregard for our government process - by, with, and for the people - is deplorable.

The CDC guidelines could have been done much better and would have been better received if our voices had been heard. And, it bothers me that the NPS overview ends with this statement, The goals of the National Pain Strategy can be achieved through a broad effort in which better pain care is provided, along with safer prescribing practices, such as those recommended in the recently released CDC Guideline for Prescribing Opioids for Chronic Pain. I doubt many of those who helped draft the NPS were aware of these guidelines being drafted when they participated in the drafting of the NPS. Some of those same people are among those who tried to hold the CDC accountable for their lack of transparency. (Read about it in The Guardian.) The CDC Opioid Prescribing Guidelines are not all bad, but they are written with a discriminatory tone, which is counter-productive to the Institute of Medicine’s report, Relieving Pain in America, available from my website here.

To me, it is more of the same and that’s really is a shame. Persistent untreated pain has biological consequences that are seldom considered, and certainly not here. A great opportunity has been squandered by lack of corroboration, something I value.

You can read my comments to the NPS and the CDC guidelines:

• Make a Public Comment on theNational Pain Strategy
• The CDC Opioid Guidelines:Exercise Your Right to Be Heard

Other blogs of interest:

• Healing What Hurts: The Politics of Pain: A Symposium Overview by Celeste Cooper
• The symposium "Patients as Teachers," "Clinicians as Learners," a synopsis by Celeste Cooper 
• A Patient Powered Network: Change Agents for Relieving Pain in America (About our group coming together to change the way pain is perceived, judged and treated.)

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"Adversity is only an obstacle if we fail to see opportunity."  

Celeste Cooper, RN

Author—Patient—Health Central Chronic Pain Pro —Advocate

Celeste’s Website: http://CelesteCooper.com

Learn more about what you can do to help your body function to its potential in the books you can find here on Celeste's  blog. Subscribe to posts by using the information in the upper right hand corner or use the share buttons to share with others.

All answers and blogs are based on the author's opinions and writing and are not meant to replace medical advice.