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EpicGenetics Offering Vaccine for Fibromyalgia

Discussion in 'Fibromyalgia and Connective Tissue Disorders' started by Melanie, Jun 26, 2018.

  1. Melanie

    Melanie Senior Member (Voting Rights)

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    EpicGenetics just contacted me and left me a message about a vaccine they are offering for Fibromyalgia patients which they have had very good success with and are trying to get FDA approval for a formal research project. They have been using a Fibromyalgia blood test that is covered by Medicare and Medicaid and many insurance companies or you can pay out of pocket (at least $750.00). I have an HMO that won't pay and I cannot afford the test.

    The vaccine is probably the old Tuberculosis vaccine. You must have tested positive on their blood test to be in the research.

    However, I am going to run this by my doctor. Who knows, maybe he will get me the vaccine anyway. I hear it is only $20-$25 and you only need one or two injections.

    Epic Genetics Website for Test and Insurance Coverage

    Phone number: 310-277-4611
     
    Last edited: Jun 26, 2018
  2. Trish

    Trish Moderator Staff Member

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  3. Melanie

    Melanie Senior Member (Voting Rights)

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  4. Hutan

    Hutan Moderator Staff Member

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    So some legitimate sounding, hospital-based researchers and the producer of an expensive blood test for fibromyalgia want to do a study to see if the BCG vaccination can cure fibromyalgia.

    The researchers suggest that the BCG vaccination may be able to help a range of autoimmune diseases. I think it was sounding as though it needs to be a re-vaccination. I have no idea if that is likely to be true, but the BCG vaccination is cheap and safe and the researchers don't stand to make lots of money out of BCG sales if they find a positive result. So, it seems to me the research itself won't harm and may just possibly help.

    But I'm interested in why the company with the blood test for fibromyalgia would be interested in supporting the research. Why would someone take an $700 test that may or may not work properly to identify fibromyalgia, and then go on to have a $20 BCG vaccination if it is positive? It seems to me, that if the blood test is negative, you would still have doubts about whether the test can correctly identify fibromyalgia. Or, if you don't have fibromyalgia, what you do have could be an autoimmune disease that the BCG vaccine happens to help too. Either way, if you were already interested in having the BCG vaccination, wouldn't you still want to have the vaccination regardless of the outcome of the test?

    Perhaps it is that, with BCG vaccinations not readily available in the US, the plan might be that the blood test will act as a gatekeeper for access to the vaccination?

    It's all interesting, not least the fact that a blood test for fibromyalgia is being promoted. It's the first I have heard of it. Thanks for posting @Melanie.
     
  5. Melanie

    Melanie Senior Member (Voting Rights)

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    I have been following this for a while and applied to my insurance company but they will not cover it. But, if this works, regardless of what the test really tests positive for (I am on the side of Fibro is an immune system disease) and more insurance companies will pick it up then that would be great.

    Yup, they will get the money for the test and that is fine with me as long as I can get the vaccine. The NIH nor other government agencies wouldn't research Fibro so someone did and for that they can have the money for the test they developed. I am also thinking the test cost will come down but if not more insurances covering it would be great.
     
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  6. Jonathan Edwards

    Jonathan Edwards Senior Member (Voting Rights)

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    Sorry to say so but this is fake science. A test that is '99% sensitive', assuming it has a similar specificity (and there's the catch because any test can be 99% sensitive if you don't bother about the specificity) is useless. It is useless because if it matches the clinical diagnosis so precisely then you get exactly the same diagnosis just clinically. It is a common myth that high levels of sensitivity and specificity are 'good' when judging tests. Moreover, it is totally implausible that any test should be anywhere near as closely correlated with clinical diagnosis in such a heterogeneous category as fibromyalgia. (Note that the rate of diagnosis of fibromyalgia varied 100-fold between doctors - which means that doctors have no agreed definition of who has it.)

    Having a BCG vaccination may do no great harm but remember that a small proportion of people, especially those who had it before, can get nasty reactions, including local necrosis. BCG is useful therapy for bladder cancer but not for immune diseases.
     
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  7. Melanie

    Melanie Senior Member (Voting Rights)

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    I'm going to my doctor in July and asking for it anyway. The drugs they have given me over 18 years have nearly destroyed me so why wouldn't my doctor do this? FDA is about to approve the research anyway.
     
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  8. Hip

    Hip Senior Member (Voting Rights)

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    It is Dr Faustman at the Massachusetts General Hospital who plans to test the BCG vaccine to treat fibromyalgia. She has already conducted a phase I clinical trial using BCG vaccination to treat type 1 diabetes.
     
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  9. JamBob

    JamBob Established Member

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    Faustman Lab released new data for their trial of BCG for reversing longstanding T1 diabetes this past week. I don't have a clue what the discussion in the study means but a drop in Hba1c as a result of getting 2 injections of BCG is definitely interesting for T1 diabetics. The number of patients monitored for this trial was small but they are currently undertaking a larger scale study.

    https://www.nature.com/articles/s41541-018-0062-8

    From this week's NPJ Vaccines article:

     
    Last edited: Jun 28, 2018
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  10. Daryl

    Daryl New Member

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    I had the EpicGenetics test done and my results were 85 on a scale of 0-100. They informed me that everyone who tested positive will be notified when the clinical trial receives FDA approval. They make it sound like that will happen in the next month or so. I'm staying in contact with them in hopes that I can participate in the trial. It's my understanding that the BCG Vaccine for fibro is a slightly different strain than what was used for TB. I'll see if I can find a link to the article where I read that.
     
  11. Melanie

    Melanie Senior Member (Voting Rights)

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    So, my doctor said he would read up on the research, but would rather wait until the research is finished before making a decision. So, I can't get it yet.
     
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  12. Melanie

    Melanie Senior Member (Voting Rights)

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    If you do, and you are allowed to let us know what is going on, keep us updated.
     
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  13. Melanie

    Melanie Senior Member (Voting Rights)

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  14. Inara

    Inara Senior Member (Voting Rights)

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    They write: "The blood test is now covered by most insurance, including CHAMPVA and Medicare."

    and here
    https://fmtest.com/#right-for-you
    "The FM/a® Test, is the first and currently only objective, FDA-compliant (FDA CFR866.500) blood test for fibromyalgia."

    If this is "fake science", why is that happening?

    Edit: Sincerely. I don't understand it.
     
    Last edited: Jul 22, 2018
  15. Inara

    Inara Senior Member (Voting Rights)

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    Here's the abstract from one of their papers
    "Unique immunologic patterns in fibromyalgia"
    https://fmtest.com/wp-content/uploads/2017/03/Unique-immunologic-patterns-in-fibromyalgia.pdf:

    I see two possible drawbacks here: Good numbers, but too small for generalization or to say "unique" (?). And second - a common problem I hear - what about lab standards? (I think @Jonathan Edwards meant this with reliability?)

    What about the method they used? Does anyone know?

    I think this is an interesting topic. Not only have several people with ME FM also, but I wonder about a possible diagnostic test for ME. If such a test can be found for FM this may give hope for ME - if this is not performed scientifically sound, then how big is the probability to succeed in ME somewhere in a lifetime?

    I also wonder if ME would skew results in this test for FM. Maybe this test is only an option for people who have FM only?
     
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  16. alex3619

    alex3619 Senior Member (Voting Rights)

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    Specificity is always an issue until long after its in use clinically and we can see results.

    Jonathon mentions the 95% specificity and sensitivity issue, but that is commonly thought of as the minimum standard. However its highly problematic at best. First, its an arbitrary standard. Second, heterogeneity means its dubious, but it might be that they were highly sensitive in the subject selection, and so is appropriate for a specific subgroup. Specificity is always a big issue, and is the major hurdle we face in ME testing.

    We probably have a diagnostic test in the repeat CPET, with more on the way, but formally studying specificity is not easy. Its not enough to differentiate patients from controls. The ME research community needs to constantly update its comparison diseases, which for right now should probably include MS and post sepsis, though I suspect post sepsis will be problematic as its another poorly researched area. The old theories of sepsis are in severe doubt right now. I would love to see many ME and CFS docs get together and draw up a list of diseases to compare to for specificity testing.

    However a test with high sensitivity and high specificity in controls is a place to start for further testing. It is however early in the research process and has a long way to go.

    One question I would always like to know in a test like this is what is the specificity with respect to ME and CFS diagnoses for the fibro test. Its very likely its not a great specificity, due to possible dual diagnoses.
     
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  17. alex3619

    alex3619 Senior Member (Voting Rights)

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    That does not make it useless, for several reasons. First, fibro diagnoses are often hotly disputed, and a diagnostic test therefore has both clinical and legal utility. It is also confirmatory, that is if a fibro diagnosis is made then a test can support that diagnosis (but not prove it at this stage I think). The legal part has multiple relevant issues, including support for disability benefits, insurance claims, and legal disputes.

    The test is not useless but it might well be over-hyped or misunderstood if they are not careful. As the first test it also will be the comparison test for future tests. One or more of those is likely to be better and replace it as the best (currently only) test.
     
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  18. Inara

    Inara Senior Member (Voting Rights)

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  19. Jonathan Edwards

    Jonathan Edwards Senior Member (Voting Rights)

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    It does make it useless, @alex3619. This is an old and common misconception. A test is useful if it is discordant with clinical assessment in a significant proportion of cases - maybe 10% or more. Otherwise you simply do not need it. In the case of fibromyalgia, a 'test for fibromyalgia' is a nonsense because fibromyalgia is just a putative syndrome, not a pathology. Since the number of cases of fibromyalgia diagnosed by individual rheumatologists varies by something like 100 fold (there was a study on this about twenty years ago) it is almost certainly not even a useful syndrome term.
     
    Last edited: Jul 28, 2018
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  20. merylg

    merylg Established Member (Voting Rights)

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    How can a test for fibromyalgia be valid or useful, when we don’t know what it is yet? I’ve had a few Drs say I have it, and a few don’t use the term. At best I think it is a bunch of symptoms caused by some underlying disease. I’d rather know what that is.
     
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