Review: 'Through the Shadowlands’ describes Julie Rehmeyer's ME/CFS Odyssey
I should note at the outset that this review is based on an audio version of the galleys and the epilogue from the finished work. Julie Rehmeyer sent me the final version as a PDF, but for some reason my text to voice software (Kurzweil) had issues with it. I understand that it is...
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NIH post-infectious CFS study

Discussion in 'Active Clinical Studies' started by A.B., Feb 7, 2016.

  1. Sean

    Sean Senior Member

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    What if the study finds that ME/CFS has a distinct pathophysiological profile that proves or at least strongly suggests there is no primary causal role for psychosocial factors, and that profile overlaps substantially with, or is even more or less the same as, FMD?

    Instead of ME/CFS getting dragged further into the psychosocial tent – an understandable fear given the history of this farce – the reverse may actually happen: FMD (and maybe some other contested conditions) might end up being dragged into the biophysical tent.

    If the psychosocial school were not only closely involved in the study, but also had either control of the selection of patients or at least had a fair influence over their selection, then they could not possibly object to the above result and it would blow them out of the water for once and for all.

    'We tested the patients you said were psych cases, and guess what, they ain't.'

    Psychs would be relegated to where they belong for this disease, which is providing appropriate, secondary, post-onset palliative clinical care, and medico-legal support about the impact of the disease upon patients' lives.

    What I see in this study is the psychosocial school being given every opportunity to make fools of themselves. Make no mistake, they are being firmly put on the spot here, their claim is under serious scrutiny, they are being called out on the mat and told to deliver.

    If it is shown that the psychs are seriously misdiagnosing, it has profound implications well beyond just ME/CFS.
     
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  2. Sasha

    Sasha Fine, thank you

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    Then the politics, and not the science, could drag us back into the psychosomatic model. That's my fear. We're not talking about logic - if science was logical, the PACE fiasco couldn't have happened. We're not on such solid ground in the eyes of the world that we can be seen as a benchmark for organic disease.
     
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  3. Valentijn

    Valentijn Senior Member

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    A nice fantasy. But given the large number of studies which find biomedical abnormalities, yet spin them as being consistent with a psychosomatic disorder, I think we're a long way off from being able to hope for such a reaction.

    As a case in point, Dr Brian Walitt would have been chased out of research several years ago if such spin was called into question. Yet he is still happily publishing his explanations of how genetics cause catastrophizing about patients' imaginary fibromyalgia symptoms, and how abnormal brain scans fit in nicely with his theory of psychosomatic symptoms arising from central sensitization.

    It's lose-lose with these people. They will always find a way to bend reality to show how everything supports their fundamental beliefs. And while we can't convince them, at least we can try to prevent them from polluting valuable research with nasty conclusions that will appear in the titles, abstracts, press releases, and media coverage.
     
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  4. ScottTriGuy

    ScottTriGuy Stop the harm. Start the research and treatment.

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    I would put a small wager that a well designed study would uncover just that. (Or that FMD is also organic, but not overlapping with ME.)

    Operative words: well designed
     
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  5. Sidereal

    Sidereal Senior Member

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    There is no such thing as a psychogenic illness so hopefully this study will also shed some light on FMD, a neglected and understudied area of medicine.
     
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  6. John Mac

    John Mac Senior Member

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    If the ME/CFS and FMD results are similar they may try to use it as evidence to prove their psychosocial theories, "look they're as mad as each other, we told you so".

    We may end up having to prove that both illnesses are physical before being taken seriously.
     
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  7. Sidereal

    Sidereal Senior Member

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    I think it depends on what sorts of abnormalities show up in testing. Anything to do with neuroimaging and crap like that could easily be dismissed as psychogenic, central sensitisation etc. But if abnormalities in energy metabolism, microbiome etc. turn up, those issues cannot be so readily dismissed.
     
  8. chipmunk1

    chipmunk1 Senior Member

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    http://www.ncbi.nlm.nih.gov/pubmed/10772394

     
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  9. Sidereal

    Sidereal Senior Member

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  10. duncan

    duncan Senior Member

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    What's the mainstream view of Lyme disease post-treatment? Chronic Lyme?

    Both have been greatly influenced by NIH personnel.
     
  11. Sasha

    Sasha Fine, thank you

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  12. mango

    mango Senior Member

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    NINDS Post-infectious chronic fatigue syndrome (PI-CFS) study, protocol details
    This study is currently recruiting participants.

    Background:

    Post-infectious chronic fatigue syndrome (PI-CFS) refers to long-lasting fatigue and inability to exercise that can occur after a person has an infection. It can also cause pain, sleep problems, depression, and anxiety. Researchers want to learn more about its causes.

    Objective: To learn more about PI-CFS.

    Eligibility: Adults ages 18 60 who have finished at least 7th grade and either: have CFS that started after an infection OR had Lyme disease, were treated, and don t have fatigue symptoms OR have a functional movement disorder OR are healthy volunteers

    Design: Participants will be initially screened in the outpatient clinic with:
    Medical history
    Physical exam
    Intravenous (IV) line. A thin plastic tube is inserted into a vein.
    Blood and urine collected
    Questions about the participant s life and how they are feeling
    Questions from a psychologist
    Qualified participants will have:
    Magnetic resonance imaging (MRI). Participants will lie in a machine that takes pictures of their brain. They may get a dye through their IV.
    Grip strength tested
    An activity monitor to wear and diary to keep track of daily activities and amount of fatigueSaliva test
    Tests of body functions such as sweating and breathing, being upright, blood pressure, and heart rate.
    Collection of blood cells. Participants can choose to have the blood drawn through the IV or through a machine that filters blood cells and returns the liquid blood back into the participant s vein.
    Medications will be reviewed during screening. Participants may be asked to taper off certain medicines.

    After screening participants will return home. They will taper off medications and report any problems. They will also use the activity monitor and fatigue diary.


    Participants will return for a 1-week inpatient hospital visit. During the visit, participants will perform a stationary bike exercise test twice. The purpose of the exercise test is to make participants tired. Tests will be performed before and after exercise testing. These include:

    Questions about how participants are feeling
    Samples of saliva, stool, and cheek skin
    Thinking and memory tests
    Heart monitoring
    Measurements of your breath overnight
    Transcranial magnetic stimulation. A brief electrical current to the scalp creates a magnetic pulse that affects brain activity.
    Magnetic resonance imaging (MRI). Participants will lie in a machine that takes pictures of their brain. They will do thinking and exercise tasks during the MRI.
    Lumbar puncture. Fluid will be removed by placement of a needle between the back bones.
    They may also have, X-rays, and consultations.

    Eligibility

    INCLUSION CRITERIA:

    Inclusion criteria for all participants:

    -Adult participants aged 18-60 years at the time of enrollment.

    -Self-reported completion of at least the 7th grade of school.

    -Ability to speak, read, and understand English.

    -Willing and able to complete all study procedures

    -Participant has a primary care physician at the time of enrollment.

    -Able to provide informed consent.

    Additional inclusion criteria for participants with PI-CFS:

    -A self-reported illness narrative of the development of persistent fatigue as the consequence of an acute infection. The persistent fatigue may have an acute onset or become progressively worse over 6 months.

    -Documentation of fatigue starting after an infection by a physician in their medical records.

    -Meet the 2005 Reeves standardized case definition of chronic fatigue syndrome. This includes:

    --Having greater than or equal to 4 symptoms set forth in the 1994 Fukuda criteria.

    --Severe fatigue as determined using the Multidimensional fatigue Inventory (MFI): score of greater than or equal to 13 on the general fatigue subscale or greater than or equal to 10 on the reduced activity subscale.

    --Functional impairment as determined using the Short-Form 36 (SF-36): score of greater than or equal to 70 physical function subscale, or greater than or equal to 50 on role physical subscale, or greater than or equal to 75 on social function subscale, or greater than or equal to 66 on emotional subscale.

    --Symptom validity as determined using the Centers for Disease Control Symptom Inventory: score of greater than or equal to 25 on the Symptom Inventory Case Definition subscale.

    -fatigue onset greater than 6 months but less than 5 years prior to enrollment.

    Additional inclusion criteria for healthy volunteer group:

    None

    Additional inclusion criteria for Documented Lyme Infection Asymptomatic group:

    -Medical record documentation of fulfilling the probable or confirmed 2011 CDC Lyme Disease National Surveillance Case Definitions (http://wwwn.cdc.gov/nndss/conditions/lyme-disease/case-definition/2011/):

    --Probable: A case of physician-diagnosed Lyme disease that meets laboratory criteria of evidence of infection (positive culture for B.burgdoferi, or two-tiered testing using criteria, or single-tier IgG immunoblot seropositivity using criteria, or CSF antibody positive for B.burgdoferi by Enzyme Immunoassay or Immunofluorescence Assay, when the titer is higher than it was in serum.

    --Confirmed: A case of erythema migrans with a known exposure, or a case of erythema migrans with laboratory evidence of infection and without a known exposure, or a case with at least one late manifestation that has laboratory evidence of infection.

    -Have received accepted antibiotic treatment for Lyme Disease greater than or equal to 6 months prior to enrollment but less than 5 years prior to enrollment documented in their medical records.

    Additional inclusion criteria for functional movement disorders group:

    -A self-reported illness narrative of the development of persistent, paroxysmal, or episodic motor symptoms as the consequence of an acute event or exposure or occurring with an acute onset.

    -Diagnosis of clinically definite FMD utilizing Fahn and Williams criteria.

    --Documented psychogenic movement disorder: persistent relief by psychotherapy, suggestion or placebo, or observed without the movement disorder when unobserved.

    --Clinically established psychogenic movement disorder: inconsistent over time or incongruent with a classical movement disorder, plus other false neurological signs, multiple somatizations, obvious psychiatric disturbances, distractibility, or deliberate slowness.

    -The diagnosis of FMD must be made by a neurologist and documented in their medical records.

    EXCLUSION CRITERIA:

    Exclusion criteria for all participants:

    -Active infection (e.g. influenza, urinary tract infection) by history, physical examination, or laboratory evaluations at the time of enrollment

    -Current or past psychotic disorder including depression with psychosis, bipolar disorder, and schizophrenia

    -Current DSM-5-defined major depression disorder, generalized anxiety disorder, post-traumatic stress disorder, panic disorder, or obsessive-compulsive disorder unless managed for more than six months with a stable treatment regimen

    -Current or prior substance use disorder as diagnosed on the Structured Clinical Interview for DSM-5 (SCID-5) or positive urine toxicology results at enrollment

    -Current suicidal ideation

    -History of head injury with loss of consciousness, or history of head injury with amnesia lasting greater than a few seconds

    -Current (within 1 week) use of prescription or over-the-counter medications, herbal supplements, or nutraceuticals that may influence brain excitability that the potential participant is either unwilling or clinically unable to safely wean off for the duration of the period of the inpatient admission. The possibility for a potential participant to be weaned off medication will be cooperatively determined by both the clinical investigative team and personal physicians. Examples of medications that influence brain excitability include tricyclic antidepressants, hypnotic, antiepileptic, antipsychotic medication, stimulants, antihistamines, muscle relaxants, dopaminergic medications, and sleep medications.

    -Women who are pregnant, actively seeking to become pregnant, or have been pregnant in the year prior to study enrollment.

    -Current or previous malignancy. Certain dermatologic malignancies (e.g. basal cell carcinoma) will be allowed.

    -Current immunologic disorder (e.g. Type 1 diabetes, rheumatoid arthritis)

    -Current or previous long term immune suppressive or immunomodulatory therapy. Systemic steroid use, even short-term, must not have been used within the month prior to enrollment

    -Any medical condition (eg, congestive heart failure, coronary artery disease, chronic obstructive pulmonary disease, severe osteoarthritis, poorly controlled asthma) that would make the study procedures risky for the participant (e.g. exercise-induced angina and asthma) or that may confound the study results (e.g. untreated obstructive sleep apnea, severe osteoarthritis).

    -Participation in a clinical protocol (e.g. anti-inflammatory drug intervention study) which includes an intervention that may affect the results of the current study.

    -Inability to perform the bicycling exercise task.

    -Not willing to allow for research samples to be shared with other researchers.

    -Employees or staff at NIH that are directly supervised by the primary investigator or associate investigators.

    Additional exclusion criteria for participants with CFS:

    -Significant neurological disorder (e.g. neurodegenerative disorder, stroke, epilepsy).

    -PI-CFS disease severity that makes it impossible for the volunteer to leave the home or requires inpatient treatment.

    -Suspected, probable, or confirmed Lyme disease per 2011 CDC Lyme Disease National Surveillance Case Definitions.

    -Underlying illness that may cause fatigue such as thyroid dysfunction, hepatitis, or other systemic diseases.

    Additional exclusion criteria for healthy volunteer group:

    -Clinical relevant fatigue as determined using the Multidimensional fatigue Inventory (MFI): score of > 8 on the generalfatigue subscale or > 6 on the reduced activity subscale.

    -Significant neurological disorder (e.g. neurodegenerative disorder, stroke, epilepsy).

    Additional exclusion criteria for Documented Lyme Infection Asymptomatic group:

    -Clinical relevant fatigue as determined using the Multidimensional fatigue Inventory (MFI): score of > 8 on the generalfatigue subscale or > 6 on the reduced activity subscale.

    -Significant neurological disorder (e.g. neurodegenerative disorder, stroke, epilepsy).

    Symptoms or diagnosis of Post-Lyme Disease syndrome

    Additional exclusion criteria for functional movement disorders group:

    -Clinical relevant fatigue as determined using the Multidimensional fatigue Inventory (MFI): score of > 8 on the generalfatigue subscale

    -Significant neurological disorder (e.g. neurodegenerative disorder, stroke, epilepsy).

    Number 16-N-0058Sponsoring Institute National Institute of Neurological Disorders and Stroke (NINDS)

    Recruitment DetailType: Participants currently recruited/enrolled Gender: Male & Female Min Age: 18 Max Age: 60

    Referral Letter Required: No

    Population Exclusion(s): Non-English Speaking; Children

    Special Instructions: Currently Not Provided

    Keywords: chronicfatiguesyndrome; Lyme Disease; Healthy Volunteers; Movement Disorder

    Recruitment Keyword(s): None

    Condition(s): chronicfatiguesyndrome

    Investigational Drug(s): None

    Investigational Device(s): None

    Intervention(s): None

    Supporting Site: National Institute of Neurological Disorders and Stroke

    Principal Investigator
    Avindra Nath, M.D. National Institute of Neurological Disorders and Stroke (NINDS)


    Referral Contact
    Brian T. Walitt, M.D.
    National Institute of Neurological Disorders and Stroke (NINDS)
    BG 10-CRC RM 2-1339
    10 CENTER DR
    BETHESDA MD 20814
    (301) 451-1683 brian.walitt@nih.gov


    For more information:

    Patient Recruitment and Public Liaison Office
    Building 61
    10 Cloister Court
    Bethesda, Maryland 20892-4754Toll Free: 1-800-411-1222TTY: 301-594-9774 (local),1-866-411-1010 (toll free)Fax: 301-480-9793

    prpl@mail.cc.nih.gov
    Clinical Trials Number:
    NCT02669212

    http://clinicalstudies.info.nih.gov...-0058.html@chronic@fatigue@syndrome@@#summary
     
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  13. anciendaze

    anciendaze Senior Member

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    There is a much simpler question to ask concerning hypotheses of psychosomatic causation: how could these be falsified? If there is no means of falsification the hypothesis cannot be tested in scientific research, and attempts to do so are a waste of resources. Does NIH champion wasteful research as a means of supporting people who are of no use elsewhere?

    The parallels to PACE are strong because even showing that a year of CBT produced zero change in physical performance had no effect on strong claims of efficacy. Nor did the finding that a year of GET produced only questionable improvement in performance leaving patients in the same range as those with advanced congestive heart failure. These could still be counted as recovered!

    Likewise the finding that it was impossible to distinguish those in different arms of the study at 3 years led to the astonishing claim that those in all arms somehow benefited from the ascendancy of the BPS school dominating the U.K. approach to ME/CFS, and thus there was no need to do anything else because the problem would eventually go away. What we have there is a trial of a proposed intervention which can be counted as successful if it merely delays or temporarily modulates patient symptom reports without any other effect. That trial was also constructed in such a way that it was impossible to decide if specialist medical care was superior to care by an ordinary GP/PCP, or no care at all. The one thing this could never show was that the overall NHS approach was totally failing ME/CFS patients.

    I don't want to deal with narrow parallels here, but I do want to make it clear that the only way such a trial could have failed was by killing a number of patients. Since most of us are very clear about having a chronic rather than progressive disease, this standard is inappropriate in the absence of clear malpractice. We need to make it clear to researchers that standards used for progressive disease will only return the predictable result that this is not such a disease.

    What is more outrageous, we have since seen that some in the U.K. believe that patients deaths are also grounds for recommending more of the same BPS, just like an absence of patient deaths. This is a characteristic of snake oil.

    Added: No, those who thought there was a non sequitur in my argument about using both deaths and an absence of such to forward the same argument for therapy have missed something important. The PACE study was done on 640 patients out of an initial intake of 3,158 thought to have CFS by GPs/PCPs. For the purposes of that study it was only necessary to choose 640 patients who were unlikely to die of any cause within a year out of 3,158.

    When it came time to argue that suicide was a special risk, other authors used an unfiltered cohort of 2,147 assembled using a grab bag of diagnostic criteria, but with no special concern for risks of mortality over a 7-year period. Given the ability to choose which patients you treat it would be easy to eliminate most or all of the reported deaths from any cause.

    The null hypothesis for safety and efficacy of proposed treatments is quite strong here. The magic comes from which patients you select and how you select them. Had the suicide study also been limited to one year it might well have reported none. The background rate for a comparable group from the general population would predict that one person would be about 5/6ths dead from suicide.
     
    Last edited: Feb 24, 2016
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  14. anciendaze

    anciendaze Senior Member

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    This just in from a correspondent with a solid diagnosis of a life-threatening illness which has been mistaken for CFS in a number of cases, based on what doctors have told him. The proper term for a cohort of patients presenting similar difficulties for doctors would be PFH ("Patients From Hell.")
     
    Last edited: Feb 24, 2016
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  15. Bob

    Bob

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    I don't know if this video of Walitt has been posted previously:
    www.youtube.com/watch?v=1DTwkooHUF8



    In this video (at 98 mins) he asks if fibromyalgia is a neurologic disease or a "social-cultural construct .. that are shaping and creating these experiences". Note that he doesn't state that this is his opinion.

    The presentation has a mixed message. He does discuss medication and says pharmaceuticals can be helpful, but he says pharmaceuticals shouldn't be the primary source of therapy or it will lead to failure, and that behavioural approaches should be the primary focus. He also advocates cognitive/behavioural therapies. He says the available drugs (e.g. gabapentin) give small benefit.

    To give a fair and balanced representation of his presentation, i should also say that he includes a slide that states that fibromyalgia has "neuro-biological underpinnings", and he also confirms this in his oral presentation. (Watch at 144.30).

    Don't ask me about his bizarre sexualized and brutalized images of women that are supposed to represent his female fibromyalgia patient. (Watch at 93mins.) If I was his female patient, I'd be slightly concerned. But I might be reading too much into it. Is it Freudian imagery?
     
    Last edited: Feb 24, 2016
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  16. CFS_for_19_years

    CFS_for_19_years Hoarder of biscuits

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    Holy sh** @93mins. Bring back the frolicking naked ladies! Disturbing to say the least. It looks like the artwork is copyrighted by a Marianne Brough? (can't see the full surname). If Marianne is a patient with FM, then the imagery is an understandable construct, but I don't think they belong in a presentation.

    One slide says "Fibromyalgia is a constant state of perceived physical and existential suffering in the absence of any observable physical cause."
     
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  17. Sean

    Sean Senior Member

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    The lack of falsifiability is at the core of the problems with BPS theories about ME/CFS/FM, etc.

    "...any observable physical cause."

    And there is the problem with this form of 'reasoning'. Make one tiny little change to one word, and the whole meaning changes completely:

    "...any observed physical cause."

    The first claim is absolute (there is no physical cause), and the second is conditional (we have not yet found any physical cause).

    Scientific claims are always conditional (and tentative).
     
  18. rosie26

    rosie26 Senior Member

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    LOL, you made me jump to 93 minutes and I have to say I found the pictures both hilarious (because I wasn't expecting to see pictures like that) and yet in a way the pictures were sadly true in a way that I can identify at the level of my own experience. I tried to listen to what he was saying at the same time. I actually can relate surprisingly to how he was trying to express the enormous life change that fibromyalgia causes. I only watched a few minutes and will try over the next few days to listen a lot more.

    Note: I may change my view when I watch the whole thing properly though.
     
    Last edited: Feb 24, 2016
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  19. Ecoclimber

    Ecoclimber Senior Member

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    I have an issue so you can skip this post as might be off topic. Warning Soapbox ahead.

    This all started from reading an article conerning Parkinson Disease and knowing about Michael Fox struggles and my father-in-law. It is effected by reading all the bad science in published research articles surrounding our issue with the NIH.

    The problem I am beginning to observe is incredible amount of bad or junk science that gets past as credible. I am beginning to believe that the medical establishment has surrender their entire position to the bio-reductionist, BPS paradigm of bio-medical denialism. This is influencing research in so many ways in the manner in which clinical trials are designed to the methodology concerning the interpretation of results. Instead, how about focusing back on scientific methodology and kick the BPS out the door. The BPS momentum is flyinging down the tracks and it difficult to stop a speeding train.

    This was the disaster which affected DSMV. Every activity could be labeled a mental health illness or disorder. Good Grief! Heart disease could easily be viewed as a psychiatric disorder due to stress, anxiety, ocb, overeating... Take for example narcissistic personality disorder. You could label almost every one in the psychiatric and mental health field, scientific research field, doctor, Hollywood actor, politician with a narcissism personality disorder. I believe that there should be a national law passed requring every mental health practicioner to take a battery of mental health tests so that they are free from any mental health issues to prevent transference of issues onto their patients or in research. Mental health practitioners should undergo the same battery of tests one would give to those in law enforcement.

    The reason for my soapbox is researching functional movement disorder. I wouldn't put it past some researchers that if you move, you have FMD. I can across a booklet put out by the National Parkison Foundation called Parkinson: Mind, Mood & Memory. Parkinson is not considered a disease but is now considered a the quintessential neuropsychiatric disorder. The booklet makes assumptions like ever suffer anxiety or depression in early life, you could develop PD.

    My father-in-law was very influential farmer. I can't give out too many detail for fear of disclosure. He came down with Parkinson. He got PD from environmental causes. His whole life was spent around spraying his fields with herbercides and insecticides. So instead of delving into early childhood abuse, lack of proper potty training, women fixated on their fathers or whatever, how about researchers remove thier myoptic viewpoint on causation that they have been brainwashed with throughout their education and focus on other possible factors. I don't know...ah how about like using chemicals in sheep dipping could cause environmental damage to your DNA that leads to ME/CFS. How about investigate exposure to heavy metals and toxins, depleted uranium, biohazard material could lead to GWI. Why do they refuse to investigate? Because group think knows that chronic pain, fatigue, fibro were caused by a maladaptive psychosexual crisis development in early childhood.

    If such a group think among these type of research scientists were ever involved with computer science, the internet would have never been possible.
     
    Last edited: Feb 24, 2016
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  20. beaker

    beaker ME/cfs 1986

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    The same artist name is on all of them. I tried google and got nothing. I know that ICA( interstitial cystitis association) once had an art contest or exhibit of patient's work showing what it felt like to have IC.
    I am wondering if this strange bit of art could be from someone who did the same sort of project for chronic pain ??
    Trying to find a reason for the choice of this artist. She is listed on slide as Marianne Bruughs . And google wants it to be Brough but that doesn't work either. Just a thought.
     
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