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Lyme testing

Discussion in 'Lyme Disease and Co-Infections' started by Esther12, Sep 10, 2013.

  1. Ema

    Ema Senior Member

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    I'm not sure why you think they are not doing this though in the same fashion as every other certified lab.

    If NY state is satisfied with the reliability and credibility of the lab, and they have the most stringent requirements to be satisfied, I'm not sure why that is not taken into account at all.

    All lab companies are for profit. Where is the clamoring for LabCorp to be funding and publishing double blinded trials on all of their testing? Their Elisa test has been shown to be no better than chance. So why aren't people calling it a waste of money?

    Antidepressants have been shown to work no better than placebo in some studies yet they are still raking in billions of dollars for depression. But that isn't evidence based treatment any longer. So why not single those companies out for scorn and derision?

    Examples like these are everywhere which is why insisting on evidence based medicine only makes no sense. Sometimes the evidence is wrong! Especially where huge amounts of money are in play. It's throwing the baby out with the bathwater.
    sianrecovery likes this.
  2. Esther12

    Esther12 Senior Member

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    I've been deeply critical of the exaggerated claims that some make for the value of antidepressants (although I think that the evidence showing that they are of no more value than placebo largely reflects that they are over-prescribed, than of no real use to anyone. I've also seen the complaint that Kirsch is using an unfairly high standard for a clinically meaningful difference in his work... I quite like the idea of using a fairly high standard before routinely prescribing psychoactive medication to a group of patients). I've repeatedly complained about the way in which results are spun, and data left unreleased. In no way is this indicative of any sort of double standard on my part. That these problems occur elsewhere does not make them any less worrying. It is evidence that we should not just trust 'mainstream' doctors, but in all cases, try to push for evidence to be released which allows for a meaningful evaluation of the treatments/testing being promoted.

    re NY state: I just did a google, and found a few things which seemed to indicate that NY state did not allow people to purchase Igenex's tests, eg: http://www.healthboards.com/boards/...ew-york-state-prohibits-igenex-lyme-test.html There are lots of references to concerns in this area, and complaints that Igenex has not been able to provide evidence for the validity of some of the tests which they are selling. Again though, I do not know about the specifics as to how NY assess the value of tests, or decide which tests can be sold to patients.

    re the Elisa test being no better than chance: I've not seen any evidence that this is true. It has a reported danger of producing false negatives early in an infection, and is not recommended as the sole test for diagnosing Lyme, but has been shown to have internal validity. Testing does not need to be perfect to have evidence of reliability, but we should expect some published evidence of reliability.
  3. Ema

    Ema Senior Member

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    The LabCorp ELISA Lyme test has been shown to be no better than chance. I'l look for the cite later on this afternoon.

    The google on IgeneX proves my point about the Lyme testing...they don't allow certain co-infection testing because they don't feel IgeneX has met the standard of reliability that they demand. So there are about 3 tests for coinfections that are not allowed to be sold in NY state. But the standard Western Blots are accepted as reliable and thus the lab is certified.

    I'm not accusing you of having a double standard but the brush you are using is just too wide in my opinion. I'm just pointing out that mainstream medicine suffers from these same problems too yet no one is accusing them of selling snake oil or suggesting that patients not visit traditional MDs. Wariness and research are required just like in every other aspect of life today.

    All I am saying is that standard of care and evidence based medicine do not solve all the problems we face in medicine today. In fact, they sometimes create as many problems as they solve (especially when it comes to insurance companies). The Lyme tests that are not reliable and do not help people (like the Q Ribb test that was popular some years ago) soon fall out of favor and the labs go away. Not all LLMDs are charlatans and not all traditional MDs are practicing solid medicine which should include clinical judgment and the use of case studies. To exclude everything that doesn't have a double blind randomized trial behind it excludes too much in my opinion and is a very narrow way to look at the world.

    Science was never meant to be static.
  4. Ema

    Ema Senior Member

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    From the IgeneX website regarding test validity:

    Validation Protocol

    Before lGeneX offers any laboratory developed test for clinical use, extensive validation is carried out as described in our validation protocol (part of the QC-QA procedure), This process has been reviewed and accepted by CDPH, CMS and NYDH. Before a new test can be offered in New York State, NYPH has to review and accept the new test validation.
    The following tests are not offered in New York State: confirmation test for the 31kDa band on the Western blot, Lyme Dot-Blot assay (LDA), Lyme lFA, Bartonella FISH, CD57 and B. duncani lFA.
  5. Esther12

    Esther12 Senior Member

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    Hi Ema.

    I regularly do accuse mainstream medicine of selling snake-oil, and of failing to properly gain informed consent for interventions. I'm not instinctively deferential to mainstream doctors on this, and think that it is important that we push for certain minimal standards everywhere. I'm certainly not saying that standard care and evidence based medicine solve all the problems we face - not by a really long shot!

    We all have different preferences and some patients will choose, in an informed way, to partake in testing and treatment that are lacking in a good evidence base and that I think are dodgy. So long as they're genuinely informed as to the absence of evidence for the value of these interventions, that is up to them.

    re the Igenex and NY state: Also, in addition to the concerns about some of their testing, there is also the concern that some of their more standard testing is interpreted in unorthodox ways, so while their procedures are sufficiently reliable, the results given to patients are misleading.

    In the case of the claims about alternative-Lyme testing being useful for understanding the symptoms of a significant number of patients... we've been waiting for well over a decade for good evidence that this is the case. I don't think that it's a good idea to go on giving them the benefit of the doubt.

    I think that I may be more cautious than many others, and more troubled by those who make medical claims that are not supported by good evidence, but I also think that the alternative Lyme theories have gone on for too long without compelling supporting evidence. When I first heard of them, I thought that they were plausible and required investigation. Since then, the evidence that has emerged has been against these theories, when if they had been accurate, compelling supporting evidence should have been easy to gather.
    barbc56 likes this.
  6. Ema

    Ema Senior Member

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    While I am glad to hear that you are equally as critical of mainstream medicine, I think that the statement above is overly simplistic.

    Who is going to fund these double blinded studies that should be so easy to gather? These studies require millions of dollars to execute properly. With the bias against Lyme and no real money to be made of the antibiotics that are commonly used to treat the disease, there is no impetus. Capitalism does not care about helping people get well because we are cheap and replaceable.

    The LLMD doctors? They are struggling to stay in business in a climate where most cannot take the time with the patient they need and still participate with insurance. Most do participate with research whenever feasible. They should bear responsibility...but the responsibility to generate millions of dollars of research funds and still maintain a practice and a life is too much to ask.

    The CDC? I think we've already covered the failures of the CDC in both ME/CFS and Lyme elsewhere.

    The FDA? Not likely. They can't even protect us from adulterated meds very well...not to mention the conflict of interest in their funding by Pharma.

    http://www.economist.com/news/busin...revolution-cheap-generic-medicines-hits-fresh

    I don't think there is some giant conspiracy against Lyme but I do think that there is no financial incentive to do the sort of testing that you require. This is the case for many treatments and medicines as well unfortunately. Who will undertake such studies if there is no financial reward for doing so? It's not as simple and straightforward as you make it out to be unfortunately. None of it is.
  7. Esther12

    Esther12 Senior Member

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    I don't think that's necessarily true. A good preliminary study could be done using samples from those who are already planning to purchase tests and healthy controls. There would be some extra trouble and cost compared to normal, and the more money one has, the more care that can be taken, but blinded testing of multiple samples for 30 patients and 30 controls would not cost a lot, and if it provided strong positive results, would be able to attract further funding. The absence of compelling supporting evidence for their theories means that it will be difficult to attract huge amounts of new funding, but that does not prevent cheaper research from being done and published.

    If this testing was really able to help understand the cause of a large number of people's health problems, then that would be a major scientific breakthrough. Publishing good research like this does come with rewards.
  8. Ema

    Ema Senior Member

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    "Cheaper" research is still going to cost hundreds of thousands, if not millions of dollars. It's not that simple.

    And testing has been done for validity at IgeneX, just the same as it has for every other test offered by every other maintream lab. I agree more transparency would be better. But again, testing is just ONE piece of a very difficult clinical puzzle.

    How do you explain all the double blinded studies that turned out to be faulty? The CBT studies for ME/CFS? The deeply flawed WHI studies on hormone replacement in women? These were exactly the type of studies that you hold up as the gold standard and they were found to be every bit as wrong as wrong can be. People suffered because of these studies. This isn't to say that they shouldn't be done but to hold them up as the only type of irrefutable evidence is just naive.

    And mainstream medicine would have to accept the possiblity of chronic Lyme first. The research that has been done is just swept under the rug at this point and dismissed as irrelevant.

    The battles with Lyme (and ME/CFS) are not about the testing. They are about the very existence of the disease. Only after we reach that point, will we be able to even have a shot at getting the sort of testing you describe. In the meanwhile, it isn't reasonable to expect that there should be no treatments or testing, even if they are not the perfect sort that you describe.
  9. Valentijn

    Valentijn Activity Level: 3

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    Actually those studies are known to be of poor quality. Government agencies just pretend otherwise, since those studies offer the cheapest "solution".

    No CBT studies have ever been double blinded, or even single blinded. They're worthless, and all of the conventional wisdom says they're worthless, yet some people choose to people pretend otherwise.

    Regarding Lyme testing, I think it's very much a new frontier. Things have not been definitively proven one way or the other, and certainly not to the extent that there is widespread acceptance. But I figure it's the sort of thing that is worth a shot - if the symptoms match up, and there's some indication from clinical results that there might be Lyme, I don't see much harm in treating it.

    If someone has the symptoms of chronic Lyme, they are very sick and it's certainly worth trying something instead of waiting another 20 years. There's a lot to be gained and not a lot left to lose.
    Ema, SOC and Sushi like this.
  10. Esther12

    Esther12 Senior Member

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    The difficulty of accounting for response bias in CBT/GET studies, and failure to single blind assessment in trials, is a big problem. And something I've been deeply critical of. I spend way, way more time reading about and criticising poor quality psychosocial CFS stuff than looking in to Lyme stuff. I think that there are similarities in the problems though, and in both cases I think it is wrong to be selling testing and treatments to patients based upon exaggerated claims about their value.

    It does seem that some choose to overlook problems that surround psychosocial CFS research, but that is no reason to lower our standards for other areas of research. It just makes it more important to criticise psychosocial quackery.

    I don't see the chronic lyme stuff as more respectable than the CBT/GET stuff. I'm generally less concerned about it because it seems not to be pushed upon patients, and instead involves patients seeking it out, but there still seems to be lots of hype, spin and exaggerated claims, and this makes it difficult for patients to provide informed consent.

    I think that cheap but still useful and meaningful blinded research assessing the value of alternative Lyme testing could be done for under $100k of additional costs. If they were confident that they had good evidence of a major medical breakthrough, this would certainly be a worthwhile investment.

    re Lyme testing being a new frontier: How much longer will this be the case? It's been this way for so long now, and still with no good evidence to support the 'alternative' Lyme claims. Surely at some point, absence of evidence is evidence of absence, particularly when it is claimed that we already have meaningful tests which should provide clear evidence as to the value of 'alternative' Lyme claims. On a personal level, I am entirely sympathetic to the calculation of 'not much cost to treatment, possible amazing benefit' - but a similar equation can come in to play with almost all alternative treatments. I feel uncomfortable with it, and it can easily lead people who are desperate to get better to put their time, money and effort into interventions being sold with a really poor evidence base. As someone else who is desperate to recover my health, and who has wasted my own time and efforts on treatments which were promoted with dishonest and exaggerated claims of efficacy, I want to help ensure that other patients are properly informed as to how poor the evidence base is for some of the medical interventions being sold, as I worry that many do not really realise.
    Svenja likes this.
  11. Ema

    Ema Senior Member

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    Lyme will be a new frontier until it is accepted by the mainstream and studies are set up. I have no Idea how long this will take but based on history, it could be decades. It is unfortunate but things move slowly in traditional medicine. Change often takes decades or more to evolve.

    It's worth a few hundred dollars to get good Lyme testing if you have symptoms indicative of Lyme in my opinion. The whole shebang ought not to cost a patient more than a few hundred dollars to rule out what can be a life killing disease syndrome.

    I'm not sure what you mean about absence of evidence. There is plenty of evidence out there that treating Lyme can change lives. It just isn't of the sort you are willing to accept. Does that mean that mistakes aren't made? Of course not, but again that is hardly limited to Lyme disease. It's the same as any other diagnosis or treatment.

    That's my whole point here...Lyme is no different than a multitude of other diseases. MS, lupus, fibromyalgia, Parkinson's etc etc etc all suffer from exactly the same problems. So why single out Lyme?

    It isn't lowering of standards to accept other forms of evidence as worthwhile. It is simply being realistic and wanting to move at a pace greater than a snail. I doubt we will see any groundbreaking research or treatments into ME/CFS in my lifetime. Does that mean we should all sit here and do nothing? That just makes no sense when there are treatments out there that may provide some symptom relief.
  12. sianrecovery

    sianrecovery Senior Member

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    There seems to be a fundamental subtext to one side of this debate that us poor patients are just too damn thick or brain-fogged to make rational decisions on the basis of faulty or incomplete information. I haven't tested for Lyme because it's expensive and the techniques are emergent, but I will when I'm ready. Why wouldn't why want to assemble as much information as I can? I did test for protomyxzoa - an even more controversial diagnosis, and got a positive.Of all the interventions that have restored some quality of life to me, antibiotics are probably second from top, with thyroid hormones at the top. I have chronic issues with infection partly as a result of a kidney disorder. Antibiotics are a high risk strategy, and they have a cost. Their effects are also largely transitory. But they have made enough difference to me to justify their place in my arsenal. Waiting for mainstream diagnostic techniques to be developed for chronic infectious diseases is likely to be a long, unproductive wait. I am capable of sifting through the bs to make choices. But thanks for your protective concern.
    SOC likes this.
  13. Esther12

    Esther12 Senior Member

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    What if it really is the case that the alternative testing is of no value? How long will it take before it stops being reasonable to go on selling it without good evidence of validity, because Lyme is a 'new frontier'? These sorts of justifications can be used for all proposed interventions.

    We all have different preferences for risk, cost, etc. With health problems, it is worth doing almost anything to regain one's health, and this does create perverse incentives, which is probably why there are so many dodgy possible interventions available to people. There's little financial incentive for people to look critically at the evidence and say 'Sorry, I don't see a legitimate way of making money from claiming to be able to help with your health'.

    Sorry, I didn't really understand this bit: "MS, lupus, fibromyalgia, Parkinson's etc etc etc all suffer from exactly the same problems. So why single out Lyme?"
  14. Esther12

    Esther12 Senior Member

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    That's right. I don't think that people are able to make rational decisions on the basis of faulty information. Faulty information distorts rationality, no matter how bright or clear thinking one may be. It is not remotely paternalistic to realise this or be concerned about it.
    barbc56 likes this.
  15. Ema

    Ema Senior Member

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    The testing is not of no value. It's just not of ALL the value!
    SOC likes this.
  16. snowathlete

    snowathlete

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    Hi Heaps!
    My cd57 was comfortably in normal range but I may not have Lyme; hard to be sure either way given my results.
  17. Esther12

    Esther12 Senior Member

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    But there's no evidence that the alternative Lyme testing provides any useful information over that which can already be gained from 'mainstream' testing. If there was good evidence that it was of some real value, then that would be quite different.
  18. Ema

    Ema Senior Member

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    But that's not true...the IgeneX testing for example tests differently than LabCorp and their methods have been shown to be more sensitive. They test for two strains whereas LabCorp only tests for one. Further they report bands in levels of strengths as opposed to just positive or negative. If there is some activity on a band, even if it is weak, there is value to knowing that it is indeterminate rather than simply negative.

    Plus IgeneX tests for two bands that Labcorp and Quest do not. These are vitally important bands but the CDC excluded them for reasons that have nothing to do with clinical utility. The CDC criteria in their own admission was never meant to be diagnostic. The 31 and 34 band are crucial information that the mainstream labs leave out.

    Labcorp starts with an ELISA test and then reflexes to a WB if the ELISA is positive...but the ELISA is no better than chance so you may never get properly tested at all through a mainstream lab.

    The Infectolab testing is totally new and hasn't had any time at all for the sort of studies you want. But it can actually show Lyme bacteria growing from a blood sample. That's not of no value! Healthy people do not have Bb bacteria growing in their blood.

    I don't know what else you call those features other than "real value" especially when you consider that the costs are similar to mainstream labs.
    sianrecovery and SOC like this.
  19. Ema

    Ema Senior Member

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    But it is paternalistic to restrict choices based on a standard that is itself faulty throughout history.
    sianrecovery and SOC like this.
  20. Ema

    Ema Senior Member

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    I don't know if you've taken abx long enough. I think there may never be "long enough" so long as the immune system is malfunctioning unfortunately. If you're still having symptoms, I think you have to at least consider that it may not have been long enough.

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