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It’s challenging to write this blog and not have an opinion. This is important fibromyalgia news that the community needs to read through.

If you have taken the fibromyalgia blood test in the past, I’d love to hear from you.

Here are some updates and understandings:

The Center for Science in the Public Interest (CSPI) has filed a lawsuit against EpicGenetics, accusing the company of making false and misleading claims about its diagnostic tests for fibromyalgia and a condition it calls “Immune Deficiency Disease” (IDD). The lawsuit alleges that EpicGenetics’ FM/a Test, claimed to be “99 percent accurate,” even though it can show a false positivity rate, particularly in individuals with rheumatoid arthritis or lupus. Other autoimmune diseases and conditions like Lyme disease where also never tested. The company also marketed an identical test for IDD, a non-recognized medical condition, as “100% accurate.”

Accusations extend to deceptive marketing practices, including false promises of enrollment in experimental treatment trials. CSPI aims to address the harms caused by inaccurate diagnostic tests and EpicGenetics’ alleged exploitation of vulnerable patients. The case has been filed in the Superior Court of the District of Columbia under the Consumer Protection Procedures Act. Read the full lawsuit documentation. 

Eric Boodman from Stat News first dropped the full story providing us all with honest details in 2021. READ HERE

  • “It’s one of those tests that unfortunately, it made the commercial area before really good solid studies had been done to validate the efficacy.” quoted, Andy Abril, Chair of Rheumatology at the Mayo Clinic in Jacksonville, FLA from the news article for STAT. 
  • The study from 2015, showed that 31% of those with arthritis and 29% of those with lupus also tested positive for fibromyalgia. 
  • Although the company funded and the FDA approved a 2017 fibromyalgia treatment trial at Massachusetts General Hospital, EpicGenetics pulled the funding for the study in 2018. Despite knowing the treatment trial would not go forward, EpicGenetics continued to falsely claim that people with positive FM/a Tests could volunteer for it, according to the complaint. 
  • In 2021, according to the lawsuit, the Centers for Medicaid and Medicare Services (CMS) suspended Medicare payments for the FM/a Test based on what it called “credible allegations of fraud,” in part because the test’s inaccuracy renders it medically unnecessary. The current status of that suspension is unknown because such CMS investigations are not public.  

More misleading claims can be found in many of their press releases that go back all the way to 2013. A press release from 2018 reveals a 50 percent discount on their test for children with another false claim. New Data Shows that a Majority of Children Tested for Fibromyalgia Have Been Misdiagnosed as ADHD: READ HERE

Criticism from researchers and the medical community has been continuous, but the company marched forward making money off the fibromyalgia community. Despite Researcher Criticism, EpicGenetics’ Fibromyalgia Test Does $750K in Sales in First Month: READ HERE

Other commentary:

Harriet Hall, MD also known as The SkepDoc: READ HERE

Opinion part:

This situation deeply frustrates me for several reasons. It baffles me that a medical professional could jeopardize patient care so severely. Having been aware of this test since 2013, I was never convinced by its marketing strategies. I read posts from bloggers that had spoken to the company and were always assured that the test is 93% reliable. Despite facing disagreement then and now, I firmly believe that it was irresponsible for the company to declare their test a “definitive” method for diagnosing fibromyalgia. This is particularly concerning given the evidence of false positives in their research with rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE), along with the failure to exclude other autoimmune conditions or Lyme disease. This raises the question: how many individuals were misdiagnosed with fibromyalgia when they actually had conditions like SLE?

Such undermining actions have far-reaching consequences, impairing our ongoing efforts to ensure fibromyalgia is taken seriously. With other companies on the brink of FDA approval for potentially viable treatments or diagnostics, one must wonder about the reception they will receive if skepticism continues to grow due to previous deceptions.

Considering that insurance companies were billed $1,080 for each test—with some patients paying out of their pockets—it’s disheartening to think about the alternative, potentially more beneficial uses for those funds that could have genuinely enhanced the quality of life for those living with fibromyalgia. Not to mentions that money could have funded REAL RESEARCH with projects supervised by researchers like Dr. Younger or Dr. Loggia. 

I am relieved to see that federal oversight bodies are now investigating these practices to safeguard patients. It’s imperative that we advocate for our patient community. While there may be valid science behind this test, the unfortunate reality is that false claims and dishonesty have tainted its credibility.

 

 

Written by Melissa Talwar, Executive Director, Support Fibromyalgia Network.

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