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Century-old Vaccine Gives New Hope to Fibromyalgia Community

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By Donna Gregory Burch

If someone could give you a vaccine that would cure your fibromyalgia, would you do it? That may sound like a dream, but it’s closer to reality than you might think. Los Angeles-based biomedical firm EpicGenetics and Massachusetts General Hospital researchers are seeking approval from the U.S. Food and Drug Administration (FDA) to conduct a clinical trial next year to test the Bacille Calmette-Guerin (BCG) vaccine as a potential treatment for fibromyalgia.

“BCG is a generic tuberculosis vaccine that is almost a 100 years old and has been safely administered millions of times,” explained Dr. Denise Faustman, head of the Faustman Lab at Massachusetts General Hospital. “For over 10 years, our research group at Massachusetts General Hospital have been actively investigating the role that the BCG vaccine could play in treating various forms of autoimmunity. Our current focus is type 1 diabetes, but globally BCG is being tested in a number of autoimmune diseases. Over the next two years we will begin clinical testing of BCG in fibromyalgia.”

According to the World Health Organization, more than 100 million children are given the BCG vaccine each year. It’s mainly used in developing countries where tuberculosis is still active. The BCG vaccine is not available in the United States because of the low risk of infection. In the U.S., BCG is used in a small number of patients to treat bladder cancer.

So, the obvious question is why would a vaccine for an infectious lung condition be used for fibromyalgia? The answer lies within the immune system.

Vaccines are typically given to healthy people to prevent infection. In this case, however, the BCG vaccine would be administered to fibromyalgia patients in an effort to quell their symptoms.

When EpicGenetics was tasked with creating a diagnostic test for fibromyalgia several years ago, researchers ran all sorts of lab tests on fibromyalgia patients to figure out how they differed from healthy control subjects and what might be causing their symptoms. Researchers discovered several white blood cell abnormalities in fibromyalgia patients, leading them to conclude symptoms are associated with a suppressed immune system.

“We believe [the term] fibromyalgia is a misnomer,” said Dr. Bruce Gillis, EpicGenetics’ CEO. “These people aren’t suffering with anything that’s affecting the muscles, per say. What they are suffering with is their immune system cannot produce normal quantities of protective proteins. …There are cells in the immune system called peripheral blood mononuclear cells. They are not producing normal quantities of the protective proteins called chemokines and cytokines.”

The finding led to the development of the FM/a blood test for fibromyalgia. (Yes, despite what your doctors may have told you, there IS a blood test for fibromyalgia! It’s just not widely accepted in the medical community.) The test analyzes the levels of four chemokines and cytokines found at reduced levels in fibromyalgia patients. These four chemokines and cytokines just happen to be the same ones that are boosted by the BCG vaccine.

“Given what’s been published in the medical literature, we believe this vaccine will reverse the immune system abnormalities [of fibromyalgia],” Gillis said.

Gillis and Faustman are seeking FDA approval to administer the first BCG vaccines to fibromyalgia patients early next year.

“This is the first time ever that a direct treatment of fibromyalgia will be done,” Gillis said. “As you know, the medications [currently on the market] for fibromyalgia only treat symptoms. They have no immune system benefits. [The pharmaceutical companies] concede they’re only treating symptoms but you need to treat the disease, and that’s why we’re moving ahead with the vaccine application [to the FDA].”

If Gillis’ theory holds true, then “the chemokines and cytokines that are deficient in patients with fibromyalgia will no longer be deficient [once the BCG vaccine is administered],” Gillis said. “Production levels will normalize, and you have to assume then that their symptoms will disappear. … We think we are on the cusp of something major.”

Because the vaccine has such a long history, it’s not expected to cause any major side effects in patients.

The BCG vaccine is anticipated to cost $20-$25 per dose – a nominal amount when compared to the ongoing expense of taking pharmaceuticals every day.

“We think a fibromyalgia patient would need one or two doses maximum so you can understand why I’m not getting much support from drug companies,” Gillis said.

In addition to the vaccine trial, EpicGenetics is partnering with the University of California, Los Angeles (UCLA) and the University of Illinois College of Medicine Chicago to sequence the genomes of up to 250,000 fibromyalgia patients.

“We’re looking for any type of genetic patterns or anomalies or mutations,” Gillis said.

Patients who test positive for fibromyalgia using the FM/a test will be able to participate in the genomic study.

The FM/a test currently costs $936 but is covered by some insurance companies and Medicare. EpicGenetics’ support team helps patients determine if their insurance company will cover the test. A no-interest payment plan is available for people who are uninsured or whose insurance won’t cover the test.

If you’d like to learn more about the FM/a test, visit FMTest.com. Click here to read more about EpicGenetics’ fibromyalgia genome project and the BCG vaccine study. If you’re interested in having the FM/a test, please fill out the application form on the home page at FMTest.com. If you have additional questions or experience any issues with submitting the form, you can email the company at ask@epicgtx.com or call (310) 277-4600.

Donna Gregory Burch was diagnosed with fibromyalgia in 2014 after several years of unexplained pain, fatigue and other symptoms. She was later diagnosed with chronic Lyme disease. Donna covers news, treatments, research and practical tips for living better with fibromyalgia and Lyme on her blog, FedUpwithFatigue.com. You can also find her on Facebook and Twitter. Donna is an award-winning journalist whose work has appeared online and in newspapers and magazines throughout Virginia, Delaware and Pennsylvania. She lives in Delaware with her husband and their many fur babies.

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23 thoughts on “Century-old Vaccine Gives New Hope to Fibromyalgia Community”

  1. Kaz873 says:

    What about all the Fibromyalgia sufferers in the U.K. Where the BCG is still given, now at birth, most of us have already had this vaccine at some point in our lives. I had my vaccine as a teenager and was diagnosed with Fibromyalgia just 10 years later, 20 years ago now and have had the diagnosis re-confirmed twice as different gp’s didn’t believe it was real.
    If we have already had the vaccine and still develop the disease, where does that leave us?

    1. CDW12 says:

      You would need a booster every 10 years. If you developed Fibro 10 years after the vaccine that would be just when a booster would be necessary.

  2. carol5556 says:

    I, too, am wondering what the alternatives are if the vaccine doesn’t work.

  3. ohiobetsy1965 says:

    Sorry – there is no way I would accept any vaccine, no matter how “old” and “safe”.

  4. jimcpn says:

    Of course this is all theoretical at this point, but having had a vaccine in childhood probably does not have much to do with it’s use to stimulate immune response currently. Remember, they are are not saying that fibromyalgia is caused by TB or prevented by the TB vaccine. They are looking at fibro as an autoimmune problem (or immune insufficiency problem really) and are saying this vaccine also stimulates production of immune chemicals matching the profile of what they believe is missing in fibro sufferers. They are also noting it takes a couple of doses to for the vaccine to gear this up, and it’s unlikely that a vaccination years ago is still acting in this way.

  5. gog4kitty says:

    First, I want to change my stars to 5*****.
    I live in Mexico. There is no FDAA controlled by the drug companies and thus the vaccine may be available. The thought of being out of pain after 32 years is enough to make me run up the hill and have the doc vaccinate me. But I am sensible so I would like to know if the vaccine has been tested on anyone and if so what are the results. Do you have such a link?

    1. CDW12 says:

      FDA approval for research of the vaccine is imminent. EpicGenetics are making calls to those that tested positive or who applied for the test but have not taken it (in case they would like to take the test now) and asking them if they would like to be part of the research if they are positive.

  6. Wattz_dad says:

    If there is any charge for the test for fibromyalgia like there is for Lyme disease (hundreds of dollars) I won’t be able to afford it. I was diagnosed with fibromyalgia in 2003 and after being given an opioid for pain developed scoliosis. So far no one has made the connection between the opioid and the scoliosis but a fifty year old male getting scoliosis out of the blue has to be rare. If given the chance to take two injections and getting rid of fibro I’d jump on it.

  7. :DMS20$ says:

    My child was diagnosed with fibromyalgia using the Fma test. She had seen a vast number of physicians who prescribed worthless but expensive drugs that caused bad side effects. Last year, a DO noted her trigger points and suggested having the test. I have shared the test results, 94/100, with a number of physicians who arrogantly dismissed it citing that no such test exists Although I have no problem with a person being doubtful or suspicious, but to totally disregard another possible tool told me all I needed to know. It amazes me how “doctors” are so damn closed minded to anything that falls outside their narrow view of medicine. She will be participating in the new study.

  8. jmekat says:

    I have a daughter suffering from this debillitating condition she’s a minor had it for 3 years now, been going thru all prescribed medication and its true tons of side effects that made her feel worse so were doing alternative medicine, when i read this article a few weeks back, i went to a pediatrician out of the country were they still give it to children, she informed me that if child is over 9 the vaccine acts erratical and does not have same effect and in adults it does not work but i read in a response that you need multiples can you please give me more information i really hope it works and helps all of us that are going thru this

  9. fibro1cure says:

    I want to know how to sign up for the trial for those with fibromyalgia to receive the BCG vaccine! I have had fibro for many years (and am 55 years old). It has progressed gradually and slowly (and was not brought on suddenly by an accident or anything) which leads me to believe strongly in the whole idea of it being somehow related to an auto-immune problem or disease (at least for me)! So, I think that I would be the perfect candidate to be in this trial (when it is approved and begins) and would definitely like to sign up for it! Thank you! Angela B.

    1. CDW12 says:

      Contact them now. See if your insurance will cover the test. They are about to get FDA approval for the research and those that test positive are being asked to be part of the vaccine research.

  10. FMoldtimer says:

    This is all very preliminary. First–a test that apparently hasn’t been sufficiently validated to receive general acceptance within the medical community, nor to be generally covered by insurance. To me this indicates a test that shows something, but that may not show anything of actual use in diagnosing a disease or condition. Next, the use of the tb vaccine as a treatment. We don’t know for sure what is being treated. We don’t know for sure that fibro is an immune deficiency condition. What we do know is that, having received the vaccine, we will ever after test positive for exposure to tb (since the tests look for antibodies). For anyone working in a field that requires negative tb, this will mean be subjected to unnecessary x-rays to confirm no tb lesions in the lungs. This treatment doesn’t seem like a good solution unless/until we have better evidence.

  11. mfrabaa says:

    Hello dear,

    I read your comment, let me tell you that BCG vaccine stays inactive after 8 – 10 years of being given, maybe thats why you got the Fibromyalgia after 10 years. I think it is worth retry and take the vaccine and inform us with the results.

    Thank you.

  12. eugenekayla says:

    You can contact Epic Genetics online and request the fm/a Test. However, the FDA has still not approved this vaccine for the treatment of fibromyalgia!

    1. CDW12 says:

      The FDA is about to approve of research of the vaccine.

  13. torch369 says:

    I’m going to have the test sent to me and if I test positive I’m going to get the vaccine.
    Not a fan of vaccines in general but if it helps me it’ll be worth it.

  14. torch369 says:

    I did the blood test and surprisingly my insurance covered almost all of it. I scored an 89, you have to get at least a 50 to show you have fibro and get access to the trial.
    Waiting for them to get FDA approval for the trial.
    I am usually against vaccines but if this gets rid of my fibro sign me up!

  15. CDW12 says:

    FDA approval of research of the vaccine is imminent.

    1. mlmjra says:

      How is it possible to know that approval for the research is imminent???

    2. CDW12 says:

      EpicGenetics contacted me thinking I had taken the test, but I had been turned down by my insurance company. If I had been positive on the test I could have been in the research. EG is working with the FDA and they are in communication with them and they know that the approval is coming and EG used the word imminent when on the phone with me.

  16. Tim says:

    Has anyone gotten the vaccine? If yes, are you better? This is groundbreaking but I am skeptical. I just haven’t had anything help this dreaded disease. My body feels like it has been beaten with a crowbar.

    Thank you

  17. Tracey says:

    Is there any updated information concerning the test and vaccine?

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