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Lessons from ME/CFS: Finding Meaning in the Suffering
If you're aware of my previous articles here at Phoenix Rising then it's pretty clear that I don't generally spend my time musing upon the philosophy of the disease. I find it better to spend my time reading research and trying my best to break it down to its core elements and write...
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Can ME/CFS patients in the UK choose who they go to see on the NHS?

Discussion in 'General ME/CFS Discussion' started by charles shepherd, Aug 2, 2014.

  1. MeSci

    MeSci ME/CFS since 1995; activity level 6

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    I don't think the issue was whether tests are validated, but whether treatments are. The NHS won't do the tests under their guidelines, but they can if they want to.
    Last edited: Aug 16, 2014
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  2. justy

    justy Senior Member

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    Yes, thanks, I stand corrected.
    So hard to find the brain power with M.E to join in these discussions.
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  3. justy

    justy Senior Member

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    Thanks Leopardtail for saying this in a much more eloquent way than I seem able to.
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  4. MeSci

    MeSci ME/CFS since 1995; activity level 6

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    I can' see anything defensive in Professor Edwards's message. I found it, as usual to be interesting, informative and useful. Nothing more or less. It's completely relevant to the thread, and is not quoting any specific posts.
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  5. NK17

    NK17 Senior Member

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    I'll try to join the discussion, although I'm in the US and I've been stubborn and lucky enough to find my way to Dr. Kogelnik's clinic, after 30 years of living with ME.

    Being originally form Italy, a country with a similar NHS to the one in the UK, and because I'm in contact with Dr. Carlo-Stella an italian immunologist who has done quite some research in the field of ME/CFS (blurring the lines between genetics, immunology and rheumatology) and has been in private practice for the last 3 years or so, I think I understand pretty well the horrible and inhuman abandonment that PWME have been forced to live, day in and day out, by GPs and our awful health systems.

    It is pretty clear that PWME are victims, basically anywhere and everywhere they happen to be born, live or move. Some of us have a slight advantage. I consider myself one of the more "fortunate" ones, based on the fact that since 2011 I've found an ME specialist, somebody with a young bright mind and spirit of making things move for his patients, a doctor with very few equals. I always tell Dr. Kogelnik that we are in the right place at the right time. I'm certain that the long awaited paradigm shift is about to arrive.

    I still need to fly or be in a car for several hours to go see him, but considering @justy's and most of my fellow sufferers situations, I'm pretty "lucky".

    If I was still living in Italy, I would have been diagnosed by Dr. Carlo-Stella (she is one of the co-signatories of the 2011 ICC), but she would have her hands tied by the Italian NHS and would not be able to prescribe some treatments, such as anti-vitals ( for example Valcyte which I'm currently taking because of sky high IgG's to CMV, HHV6 and EBV). To put it simply I would have to have an acute infection of CMV, when what I have are multiple chronic infections of all the herpes viruses plus a plethora of other intracellular pathogens. Even my longstanding abysmally low NK cells function would not qualify me for immunoglobulins treatments. Maybe some over the counter immune modulator would be prescribed.

    Was I still living in Italy, I would be lost, based on the fact that I don't have so far a real and clear cut autoimmune picture, apart from a Sicca Syndrome diagnose (achieved through my old rheumatologist at Ucla and by participating in the international clinical SICCA clinic at UCSF) a mildly elevated ANA (speckled, which apparently is quite common in PWME) and a handful of other diagnoses that all point toward autoimmunity, but are not the smoking gun, basically I would be screwed!

    Was I not in the US, close to OMI and able to pay out of pocket for the visits there and some off label treatments, I would simply fall through the cracks.

    Like the rest of us here on PR and the millions PWME around the world we need a major change in the way our disease is perceived, studied, researched and treated:

    - We need a better naME, because it's evident to me that CFS is a symptom, fatigue is a symptom present in many many autoimmune and non autoimmune illnesses

    - We need acknowledgement form the powers to be that ME is a serious chronic multi systemic disease, in which inflammation is very much present as well as immune dysfunction (still don't know which comes first :).

    - We need centers of excellence COE in every possible country around the world (Dr. Dan Peterson in his talk in front of some of Sweden's MP in 2011 has stated that ME is present everywhere you look for it ;). Prof. Montoya is a strong advocate of COE, he has been working tirelessly on our behalf at Stanford and advocating at the CDC and CFSAC here in the US.

    - We need more young and bright minds attracted to the shores of ME (Ryan Prior is doing this with The Blue Ribbon Foundation)

    - We need more Prof. Davis and Ian Lipkins, Jonathan Edwards, Fluge, Mella, Bansal, Blomberg, Hooper, Newton, Marshall-Gradisnik etc. etc. etc. (too many to name for my ME brain, but certainly still too few to do the research and translational medicine that is desperately needed).

    - We need powerful lobbying (easier to say than to do, when you are a bunch of very sick, invisible and destitute lot of sick people …), as the wonderful Llewellyn King has been saying.

    We are not there yet, but we are taking the first steps. Keep calm and fight on, we are slowly slowly getting where we needed to get many years ago.
    Last edited: Aug 16, 2014
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  6. Leopardtail

    Leopardtail Senior Member

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    It follows a series of responses that seemed to misinterpret Justy's original point. Like you I find Professor Edward's to be engaging and I am glad he is around, that will not stop me engaging in vigorous and playful debate though, it's how theoretical science works!!! Se the Avatar., the Leopard still has his spots... ;)
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  7. Sasha

    Sasha Fine, thank you

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    I've been thinking some more about this issue of responsibility (nothing like having one's ideas challenged to force one to think things through!).

    If we were discussing, say, some area of theoretical interest such as a new theory being proposed in an area of physics, then I'd agree that the burden of proof is usually seen as resting with the originator of the theory. If you want you theory taken seriously, you're expected to come up with the rationale and evidence to support it and if you do, others will try to replicate it and this will lead to the theory being accepted or rejected.

    However, I think it is - or should be - different in medicine when you've got severe and widespread clinical need. That's because I see it as the responsibility of every clinician treating us to try to do something to get us well, if they've got a patient willing to take a fully informed risk.

    Let's assume, for the sake of argument, that there are no convincing RCTs or clinical audit data that indicate that a treatment is promising. Should an NHS consultant immunologist seeing 100 ME patients a year do nothing, year after year? With all those wasted years of patients' lives spent in isolation and suffering? The patients aren't in suspended animation while all this time is passing. They're actively suffering, and they're carrying the consequences of a failure on their clinicians' part to take any risk. Many of us have been in this situation for decades. I think those consultants have a responsibility to look into the issue (as you have done, to your everlasting credit), form hypotheses, and start trying things out.

    However, there is some evidence in favour of some treatments, but it's not of the quality that I think you'd want to see. Let's take methylation as an example. The late Rich van Konyenburg was a physicist who studied ME/CFS and came up with a methylation protocol that lots of patients have tried (many with some improvement). He presented at conferences and his protocol was adopted by several ME/CFS specialists in the US. Dr Neil Nathan was one of them, who tried the protocol out on 50 patients and then did a more formal study on 30 more patients:

    http://www.prohealth.com/fibromyalgia/library/showarticle.cfm?libid=16138

    I don't think you'll find the study design very impressive but then, Dr Nathan is a clinician, not an expert in study design. On this forum, we discussed with Rich the desirability of getting a proper RCT done and he was very keen on the idea but recognised that he didn't have the expertise or resources to set one up and would need help. He passed away before further work could be done. The Open Medicine Institute recently successfully crowdfunded for a study on B12, which is a key part of the protocol, so at least that's one aspect of it that's getting proper study.

    I think the methylation protocol is a good example of the problems in what seems to be a chicken-and-egg scenario here, in which our NHS clinicians won't try things until they have evidence but have no evidence because they won't try things. We have people who can come up with ideas and we have clinicians (in the US) willing to try them out but they don't have the skills to design high-quality tests. You say that that's their responsibility but (I've now changed my mind!) I don't think it is their sole responsibility. They can only do their best: their best doesn't seem to be good enough. Given that that's the case, it is right to wait until someone comes along to do a proper trial? Why don't these NHS clinicians take the initiative and do that trial?

    I'm also changing my mind on the general usefulness of N=5 tests. If we had a homogenous disease population and were using very powerful treatments (such as Rituximab), we might see something in five patients. But for a lot of things, I don't think five patients is going to be enough. I think we need numbers.

    To put this on a more constructive note, we have ME specialists in the US who try various treatments. In essence, they're not just doing your N=5, but N= 1,000 or more. Is there something that they should be doing in terms of monitoring outcomes or designing a study that could make their data of sufficient quality to convince anyone? What's the difference between how you envisage your N=5 studies and the sort of retrospective or prospective, uncontrolled studies that have been done on clinical records of US clinicians using Valcyte (which, as you say, turned out to be not at all impressive in an actual RCT)?

    Thanks again for being willing to discuss all this - I think it's a hugely important issue.
  8. Leopardtail

    Leopardtail Senior Member

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    Lovely post and nice to see you included Professor Edwards in the list! Above and beyond a much higher standard of science we need sensible 'stitch in time' methods that prevent the patient falling into severe disability. Simple sensible measures such as if you patient becomes seriously ill with infections and takes months to fight them off, treat at first sign on infection (after all you know your patient won't fight it off necessary). Science told us asbestos was safe - it's not a holy grail, nor a replacement for good clinical judgement or common sense. Nothing is a replacement for those two key issues.
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  9. Leopardtail

    Leopardtail Senior Member

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    Nice thoughts on the whole... Though I would add a couple of points of caution: more hazardous treatments such as hormones should only be administered with adequate testing. not as blind experiments. If the symptoms indicate a probable issue, that testing however needs to be detailed, not a way of denying correct treatment. TSH for example becomes unreliable if you also have issues with the adrenal or gonadal axes. For low risk treatments such as Co-Enzyme Q10, I would feel a bit more flexible. B12 is fairly harmless to most people and difficult to reliably test for deficiency so again worth a cautious trial.

    At the moment is seems we are getting only a super cautious 'risk assessment' rather than a 'risk-benefit analysis'. We need the later.
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  10. NK17

    NK17 Senior Member

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    You're absolutely right @Leopardtail! If I was treated or at least told to aggressively rest, for example when I came down with mononucleosis, I probably wouldn't have progressed to where I'm today!

    I consider @Jonathan Edwards one our true advocates and a real treasure ;).
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  11. Leopardtail

    Leopardtail Senior Member

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    I would like to here more of your thoughts on 'evaluation' of treatments. With diabetes for example we test blood sugar - it's crystal clear what works. Right now it looks like all the measures boil down to subjective patient evaluation - indeed to us that's the only real measure if we don't feel good, you've not cracked it.

    What do you consider to be an achievable standard of science in the here and now?
  12. Jonathan Edwards

    Jonathan Edwards Board Member

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    As I think MedSci points out, I don't actually do 'defensive doctor mode'. However playful, that is too easy a way out. (I just do 'awkward customer' mode.) I am trying to get everyone to get their arguments really focused, that is all. And if ME, or at least CFS, is caused by a rag bag of at least 6 completely different illnesses, it seems unlikely that there are any 'proven treatments' (for ME per se) for exactly the reasons you give - it is quite impossible to do adequate trials to prove them. There may well be a profound lack of intelligence surrounding medicine in ME but we have to do better than that get the arguments right.

    So my key point is that however much I may be happy to accept that individuals with MEs have got better taking some of these treatments there is a deep chasm between that and expecting the average NHS doctor to prescribe them. And 'cautious experimentation' does not help because it does not take the proof any further - even if a few people get better on the way.

    What worries me, and rightly would worry my NHS colleagues is how many people get made worse. One of the commonest issues raised on PR is susceptibility to adverse drug reactions. This is relevant to what I mean by reporting experience in a way that is assessable by others. One of the examples posted of a trial by a private practitioner says nothing about how many patients had adverse reactions. At the bottom it says that patients DO get severe adverse reactions but nothing of this is said in the results. This is what I mean by not being properly assessable by others. When we reported on our early experience with rituximab we published every adverse event we thought might be relevant. So I agree with Sasha that the responsibility for taking forward promising treatments does not lie purely with the initiators. But what I am saying does lie with initiators is the responsibility for careful documentation that can be assessed by others.

    To me the bottom line is that medical research, particular in therapies, is a steep and complex learning curve. To begin with it is not done very well. People learn how to get more reliable data over time. My impression is that for ME we are not yet at the reliable stage - because of the problems we have discussed.
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  13. Leopardtail

    Leopardtail Senior Member

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    Understood, largely agreed with too.

    I don't actually think any treatment for ME is universally applicable. The outstanding point first made by Justy however is the issue of refusing to test for common causes of symptoms as per standard medical practice and that is the area where I remain highly critical of current medical practice. We need to get the proven stuff. E.g,. nerve pain, rashes etc are all common with B2 deficiency, hence if your ME patient shows them consider that option.

    Do you understand our point about expecting reasonable testing an investigation for known causes of problems, then only initiating treatment with good evidence of problem and good existing evidence of the solution to that issue?

    I do take your point about adverse reactions. For this reason I would not advocate blanket use of any treatment, rather caution against it. It's also worth pointing out however that where a treatment looks plausible many ME patients get most of the benefit with a very small dose and most of the adverse reactions at higher doses. Many of us also find that slow upward titration is more beneficial where there is standard treatment for a problem. My own GP did eventually take this one board and results have since been much more predictable. This was an example where her correct clinical judgement out-performed the available science. Yet that clinical judgement still made use of the science to select treatment.

    The issue with reporting I take on board, however I would levy the same criticism at many university researchers. It's not limited to private practitioners. Failing to report negatives as you indicate is common, failing to give percentages for negative outcomes is also common. Discluding 'drop outs' from statical analyses is another one that annoys me. Who would drop out of something highly beneficial? My final pet peeve is merging 'no response' with either positive or negative outcomes as suits the objective of the researcher rather then separately reporting.

    Perhaps hashing out what we consider to be a 'gold standard' for research should be a new thread?
    Last edited: Aug 17, 2014
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  14. Jonathan Edwards

    Jonathan Edwards Board Member

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    A few more replies to Sasha, with whom I have complete sympathy in principle (not meaning I don't have sympathy with every one on PR!) - but we have to look at the practical realities.
    Yes but I worked for the university. It was my job. Service consultants are not employed by the people of the UK to do research. That may be a bad arrangement and it is a bit more complicated but considering how much cost there is involved in getting useful information it will never be practical for all consultants to research new therapies.

    Absolutely we do, and more than numbers, if an effect is modest, you need placebo treated controls, or some equivalent. My suggestion was to do N=5 if you think you have a chance of picking something up. Then, or from the start if you don't, you need a large study with controls. Otherwise you simply do not know whether people got better because of the treatment or by chance.

    I think you just have to look at the way Fluge and Mella reported their studies. Over a period of fifty years we have come to accept certain basic features of trial reporting. You want controls or a good reason not to have them. You want systematic reporting of adverse events. You want detailed kinetic analysis over time so that the possible mechanisms can be considered. You want primary outcome measures defined pre-hoc. You want a pre-study power analysis ... It is all very well understood by every properly trained clinician. We have to learn this and show we understand it by presenting trials in department seminars. Everyone knows it. But some people do not follow it. There is no harm in breaking all the rules in a first 'look see' study if you think it is safe but all you are entitled to expect from colleagues is 'interesting, I look forward to the formal data in due course'.

    But, don't for goodness sake get the take away message that I think it's all a waste of time. I have just been discussing this with an academic friend visiting for the weekend. He said - yes of course all science starts off like that - mostly to be thrown in the bin. What matters is that things are building on that and moving on. You have to start somewhere. All these independent researchers have started somewhere. Bravo! But we want to go up a gear. And so far we still don't have enough for me to say to an NHS colleague - why aren't you trying such and such and see if it works - because they will not be able to tell if it really works. I used penicillamine for rheumatoid arthritis for about ten years and I never knew if it was really working even if some people got better. It was just that the trials had shown it was better than nothing so I had a duty to try it. I now have doubts about those trials but at the time they were the best we had.
  15. Cheshire

    Cheshire Senior Member

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    Thanks for all your answers; it's essential to get the view of someone behind the curtain.


    I don't think any of us is against RCTs, on the contrary, we all know we desperately need excellent trials. But in what is said in this thread, there are, I think, 2 things:

    - to which extend are we deprived of standards tests that could help relieve treatable symptoms or medical comorbidities some of us experience, because all our symptoms are just dismissed as neurotic.

    - what do we do while awaiting these RCTs results? Some of us are sick of waiting, they’ve been waiting in indifference and disrespect for years.


    And by the way, what an irony to see these standards for RCT when one thinks of the PACE Trial. Report of advese events, what a joke...
    Last edited: Aug 17, 2014
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  16. Leopardtail

    Leopardtail Senior Member

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    Personally I don't want to see wild and whacky treatments (or diets). The bolded point above is the one where I suspect almost every informed ME patient has an issue.
    The other thing I want to see is our GPs using sensible judgement, and sensible caution, rather than being terrified of everything. :)
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  17. heapsreal

    heapsreal iherb 10% discount code OPA989,

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    Even supportive care is dismissed by many doctors. There are medications out there that could help with suffering. Treat symptoms of sleep dysfunction, pain is another and most doctors will help with treating mood disorders but need to realise something like depression is a secondary issue, also as dr edwards has brought up, medication sensitivities are very common in this group of medicines we call antidepressants. Doctors need to be taught to start patients on extremely low doses eg 1/4 of a normal starting dose, might not even need to go to a full starting dose. This is just the basics.

    As much as many people dont like his sales tactics, if most doctors read Fatigue to Fantastic(name is apart of the sales tactics everyone cant stand), the basics of the treatments in that book would go along way to improving the health of many cfs/me people. It outlines symptomatic treatments, hormonal treatments as well as infectious treatments and immune disorders. Theres enough there for doctor to do further research themselves and then better look after patients.

    problem is we are seen a neurotic bunch of hypochondriacs and the doctors that think that, havent kept up with research is the last 20yrs atleast. Many cfs/me people give up on doctors and havent seen one for years as they are sick of being told theres nothing wrong, just need to exercise and take an antidepressant. If the health systems let doctors run a descent set of labs on patients then they would see many abnormalities and probably taken seriously. If they were allowed to test viral titres then they might start prescribing antivirals to the appropriate patients.

    If all the above was being done this itself would stimulate more researchers as doctors would want more answers to help us.But while they are only testing things that show no abnormalities, then they will continue to ignore us. Its a cost saving by the government to avoid testing patients and finding things wrong and then have to actively treat them, instead we ignore it and the government dont have to pay to care for these people because there isnt anything wrong with them on their full blood count, oh those things that are highlighted on the test arent important, you dont need to know what they are and no u cant have a copy either.
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  18. Valentijn

    Valentijn Activity Level: 3

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    As others have said, it's reasonable to proceed with caution regarding treatments, instead of just trying everything to see what works. The problem is that certain psychiatrists advocate that we not even be tested, because somehow being tested in itself will cause an adverse reaction, based on their psychosomatic theories.

    We have testable abnormalities on proven, mainstream tests. Those results often give an excellent direction for treatment. But doctors refuse to run those tests, because the "experts" say those tests will harm us. NICE reinforces that by advocating that obvious testing for extremely common and obvious ME symptoms be withheld.

    Another non-NHS example (sorry :D): A naturopath in the US ordered some non-mainstream tests, including a urine catecholamine test. Norepinephrine came up low. Back in the Netherlands, I ordered a blood test for catecholamines from a private lab. Norepinephrine came up very low again. Another patient here suggested a low dose of Strattera, an NRI. My naturopath in the US was willing to give it a try - after all, my norepinephrine had tested low and low norepinehprine can cause problems with orthostatic hypotension, which I had quite a lot of.

    It worked quite well. Instead of needing to lie down every hour or two, I could sit up all day typically. It reduced frequency and duration of being bed-bound (typically for weeks) due to intense periods of orthostatic intolerance. It helped raise my pulse pressure enough to lower my heart rate enough that I could get to sleep on my occasional "bad" nights, where my oxygen saturation would otherwise be plummeting.

    My Dutch GP was happy to hear this was helping, but she was extremely uncomfortable giving me a Dutch prescription, and it's illegal to import my US prescription. So she very sensibly set me up for a Tilt Table Test. That came out completely normal, with a pulse pressure of 50 throughout (I never get above 35), but was too short to catch neurally mediated hypotension - and I nearly collapsed after we made it back to the elevator. The pleasant cardiologist referred me to a neurologist colleague, to discuss the medication with him.

    By then my blood norepinephrine had been tested again (about a year after the first blood norepinephrine test), and still showed very low. We took those blood results into the appointment as well as the US prescription. The neurologist assured me that pills (and surgery?!?) couldn't help an ME patient, only exercise - despite that I just explained how much the NRI was helping me. When I questioned his statement that exercise could help me, he printed out the entire PACE paper and handed it to me. When I pointed out that it primarily involved patients with different symptoms than mine (they had to have fatigue as their primary symptom, whereas mine are PEM and OI), he declared that the actual symptoms don't matter.

    Valid tests are not taken seriously. And even if doctors have doubts about a specific test, they typically refuse to re-test in the national health care system. They believe that we have a psychosomatic disease, and they discourage and block all testing. They ignore and dismiss any evidence of abnormalities.

    It's not a matter of dodgy tests and random treatments which might cause adverse reactions. It's a matter of flat-out refusal to rationally test or treat.
    Last edited: Aug 17, 2014
  19. Leopardtail

    Leopardtail Senior Member

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    This is exactly the type of issue we have been trying to raise. Test for a well known issue, us the well proven treatment. We have harmful treatment advocated based up research that owes more to religion than science. While proven treatment for symptoms and the test that may diagnose cause are withheld.. This simply is not defensible science nor defensible medicine.
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  20. Leopardtail

    Leopardtail Senior Member

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    The focus of our argument is I feel very sharp. Assess the unique symptoms, use reasonable judgement to identify known causes, then do relevant pathology.
    This is how I worked, every test I did showed a useful result, clear pathologies were identified, so far every treatment tried based on that pathology has been successful - not a single negative outcome.

    ME is harder than average, with a clear focus and clear judgement, it's often far from impossible.

    The approach I took (the methodology not the tests or treatments) is what we are asking for. Crystal clear focus... also normal medical practice if one suffers another disease.
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