Invest in ME Conference 12: First Class in Every Way
OverTheHills wraps up our series of articles on this year's 12th Invest in ME International Conference (IIMEC12) in London with some reflections on her experience as a patient attending the conference for the first time.
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IOM contract is not evidence based

Discussion in 'Institute of Medicine (IOM) Government Contract' started by Andrew, Oct 28, 2013.

  1. Andrew

    Andrew Senior Member

    Los Angeles, USA
    I wasn't sure where to put this, so I started a new thread. But we here again and again from the government that anything new must be evidence based. The IOM contract says nothing about field testing whatever they come up with. Unless it can actually differentiate people with ME/CFS in the real world, it is not based on evidence. What it is is an ivory tower exercise in evaluating a body of literature where much of the literature is based on weak definitions. Feedback from stakeholders means nothing unless they actually act upon it in a significant way. And from what I saw of their treatment of GWS, they listened and then disregarded all the feedback.
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  2. WillowJ

    WillowJ คภภเє ɠรค๓թєl

    WA, USA
    lack of field testing is an excellent catch.

    I'm not aware that definitions produced by the physicians do this, but in that case it's based on clinical evidence.

    When made de novo by an "independent" body, it seems this is expected (e.g. DSM process), and this and GWI would fall under the category where I would think field tests appropriate.

    The thing to watch for with field tests would be what they are testing against. Would they want to match ICF/Oxford/Empirical? Would they want to match Fukuda?

    Or would they want to match the experience of the best clinicians and researchers?
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  3. alex3619

    alex3619 Senior Member

    Logan, Queensland, Australia
    (WillowJ, you posted as I was writing this. :))

    Will the real evidence-based medicine please stand up?

    It IS evidence based ... of a sort. The problem is that EBM is still under-developed, and it can be twisted and biased in many ways, which makes a mockery of the whole process.

    EBM was primarily developed to assess medical interventions, not diagnostics. Its not suitable for a diagnostic approach unless rigorous scientific processes are in place. A panel like the IOM wont be doing that, as it would require field tests etc, and probably a large patient cohort. In other words, it would be more like a ten million dollar trial than a one million dollar review.

    The APA uses a consensus approach without sound evidence. The do field trial much of it, but again this is based on subjective interpretation. Hard objective evidence: zip, nada, zilch.

    The issue with lack of objective evidence should downgrade nearly all psychogenic research.

    The lack of firm diagnostic criteria, highly subjective, should downgrade nearly all psychogenic research.

    The psychogenic research on CFS (and its not ME) should be regarded much the same way - almost none of it is evidence based, hence no evidence based research is produced. The evidence base is a null set, as it is with much of psychiatry. EBM does not apply to most of psychiatry.

    Yet almost nobody seems to have problems evaluating psych research on an evidence based scale.

    So one of the big criticisms is that, strictly speaking based on objective evidence, there is no basis for psychogenic diagnoses or treatments. On the other hand, the pathophysiological evidence, though not sufficiently tested, is at least objective. Strictly speaking they should come down in favour of pathophysiology, but I predict they will not.
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  4. alex3619

    alex3619 Senior Member

    Logan, Queensland, Australia
    There was a new appointee to CFSAC. You can see a comment I posted on evidence based here, and they apply equally to the IOM:

    The microglia hypothesis is not disproved, but neither is it proven. There is no proven hypothesis about the cause of ME, nor is there substantive evidence that these wide range of suspected conditions that might involve microglia are even closely related. There are however many good hypotheses that have substantive evidence to support them.

    One of the biggest issues we have faced all along is that as something new is discovered, someone stands up and says this MUST be the cause. Then at some later point we discover it might be part of the pathophysiology, but it was not the cause, or even that it failed to be a replicated finding.

    Exercise is beneficial in many conditions. In a large heterogeneous group, with few ME patients, it might indeed be the case that they see it as necessary. I do agree though that at some point at nearly full recovery some careful exercise might help some ME patients, and that this has to be decided based on the individual.

    I would like to know how 60% psychiatric co-morbidities were diagnosed. Using what symptoms? Using ME symptom to diagnose such, on an ME patient, is a nonsense. The same is probably true for other disorders. Very few psychiatric diagnoses are evidence based, they are nearly all based on semi-consensus diagnostic criteria and subjective judgement. In other words there is a major risk of bias in the process. Standard diagnostic questionnaires do not have any proven validity for diagnosing psychiatric disorders in ME patients. Such limited validation as has been done is suspect at best.

    One thing I would like to know of any appointee is what do they understand about evidence based medicine and its limitations? Almost no psychiatric disorder has an evidence base of its existence, and all psychiatric research proceeding on the basis the category is valid still lacks scientific credibility. EBM was developed for assessing clinical interventions, not for evaluating science. Using it to evaluate science outside of its original scope is an abuse of the process. In any case EBM itself has not been scientifically validated.

    There is no objective evidence that exercise helps ME patients when approached in ways used in other disorders. None. We are slowly getting more evidence from exercise physiologists on what is wrong and what to do, and are probably still years away from anything unassailably definitive. Any claim to the usefulness of exercise, without strong diagnostic criteria and clear objective results, is NOT Gold Standard evidence based medicine.

    We need to know what every “expert’s” grounding in science is as well, not just medicine. We need to know what criteria they will be given for collating, prioritizing and evaluating evidence. Bad criteria equal poor outcomes. Its not just about the experts.

    Are they free to reject bad criteria? Or will they be compelled to follow bad criteria? If we are not careful we will see yet another example of biased based medicine.
    Last edited: Oct 28, 2013
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  5. SOC

    SOC Senior Member

    This is one of my core concerns with this ill-conceived contract. We need a legitimate definition because it has become clear that the current body of research on ME/CFS is based on several substantially different definitions which has resulted in very confusing results. A sample group of Oxford definition patients is an entirely different set (from a research perspective) from a sample group of CCC definition patients.

    A clean, legitimate definition would allow researchers to start comparing apples to apples rather than the apples to peaches, plums, carrots, and nuts ;) situation we have now.

    SO.... IOM proposes to use that same confused body of literature based on multiple confused definitions to... wait for it... develop a definition. o_O Does that make any sense whatsoever? I don't know whether to call that logic bass-ackwards, circular, or some perverted incestuous spiral. :rolleyes:
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  6. alex3619

    alex3619 Senior Member

    Logan, Queensland, Australia
    You are wrong SOC, in one respect: they may decide we are all nuts. ;) No peaches or carrots allowed.

    Bass-ackwards sounds about right. :)
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  7. Izola

    Izola Senior Member


    A bass-ackwards,circular,perverted incestuous spiral???
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  8. Ecoclimber

    Ecoclimber Senior Member

    It is interesting that Pandora has acquireed some prescient proclivities?

    In their brochure they printed this in April
    If you live in Alabama and have or think you have a neuro-endocrine-immune disease, you have come to the right place. Neuro-endocrine-immune diseases include myalgic encephalomyelitis / chronic fatigue syndrome, fibromyalgia, chronic tick-borne infections, multiple chemical sensitivities and Gulf War illnesses. They are sometimes called "chronic multi-system illnesses." Hmmm,19095.0.html?PHPSESSID=9p6a5ojg2h4srhg7sdfaof5hu4

    Pandora web site in April listed it as multi-system and then added chronic in front of multi-system in June. Print date on the other web site showed an April date with CMI.

    So they must know that the fix is in for CMI as referencing ME/CFS, Fibromyalgia and other illnesses as CMI.

    A Gulf War Veteran writing a letter to Senators and Congressmen and finally recieved a reply from one of them on

    the lack of treatment after the IOM redesignated GWI to CMI a psychogenic disorder

    Dear Congressman Michaud:
    I want to thank you for your letter. Of all the letters I have sent out to every member of the House & Senate Committee for Veterans Affairs, yours has been the first and so far the only response.

    As for evidence as to VA denying claims on health issues related to Gulf War Illness / aka CMI, I am enclosing my last C&P examination where I point out many errors, items totally missed & some statements that one could only constitute as lies. The file is thick; however I have highlighted in red print the specific areas that are of concern. I have also added private civilian doctor’s records on some items which contradict the VA C&P examination.

    These files are just a very small portion of all the medical records, photos, audio & video files that I have. I have everything, active duty, VA & civilian medical records saved to an external thumb drive and cloud drive and can produce them upon demand. There are four backups to the files. As for the VA deliberately pushing GWI claims to “denied” status to clear the backlog. At the present time I can only produce evidence directly related to my claims. However, as a GWI advocate I hear the stories constantly concerning veterans getting denied to presumptive conditions such as IBS, Chronic Fatigue Syndrome, Fibromyalgia, etc… If you so desire I can reach out to other veterans to get their stories, point of contact & possible the evidence they may have.

    I have never desired or even had envisioned becoming a Gulf War Illness Veterans advocate. But as the years passed on with me fighting the VA trying to get help & being denied over and over, plus finding many other veterans like myself or in worse condition than myself, I had no other option. It is the Veterans Administration that converted me into a GWI advocate and I will fight for justice and to have them do the right thing until my last breath.

    I have already lost two brothers to suicide, because they could no longer take the pain related to this illness. Actually one is confirmed suicide; the 2nd was ruled an accident with a self inflicted gunshot wound to his head.

    I am very much looking forward to making several trips to Washington, DC to advocate, participate in rallies & marches to bring this matter into the main stream media. If you go to the YouTube channel listed below, I have several video uploads related to my work to advocate for justice. There is also a playlist section which includes research, documentaries, news media, etc… all related to GWI.

    I also keep a very close eye on both the Senate & Congressional Committee of Veterans Affairs. Every time either Committee goes live, I relay the information via Google+, Twitter & Facebook to the rest of the veterans & veteran related communities. I also provide them with links so that past hearings can be played back at latter times.

    Again I want to thank you Sir for your response to my latter and I do hope you take the time to look over the records I have provided. I am also hoping to hear from you again.

    Thank you,
    Glenn Stewart
    US Army & NG retired
    Gulf War Illness / aka CMI casualty and advocate
    YouTube channel:
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  9. Ecoclimber

    Ecoclimber Senior Member

    1. The historical behavior by HHS in their agencies over the last thirty years toward the Chronic Fatigue Syndrome patient community is a barometer of their attitude.APA past behaviour is a predictor of future behaviour.

    2. HHS’s current behavior involving threats, intimidation, secrecy and lack of transparency in awarding this contract to the IOM indicates an ominous cloud of suspicion. Why the smoke and mirrors?

    3. Observing the results by HHS on another vulnerable population, the Gulf War Veterans, ten years, 9+ reports, millions of taxpayer dollars spent to change a three letter acronym from GWI to CMI so as to deny their access to medical care.

    4. There has been a failure of some patients to exercise due diligence in researching the historical record concerning the relationship between HHS and the IOM.

    5. One must consider the political sphere in which policy decisions are made and most importantly on how the multibillion dollar global insurance conglomerates and their lobbyists are arrayed against this patient community.

    6. Why would patients support Vernon, CFIDS, Pandora and other ‘co-opted advocacy groups’ over the opposition to the IOM contract of more than 50 of the top ME/CFS researchers/clinicians who have dedicated 30+ years on behalf of this patient population?

    7. Patient population fails to realize that the purpose and policy of the IOM is to move medical care from symptom base medicine to evidence based medicine. Because ME/CFS has no verifiable biomarkers established through medical diagnostic testing in a clinical setting, classification is automatically moved into the psychogenic trash heap… the reason that HHS only wants a one day CPET test for fear of finding a possible biomarker.

    8. As in the Gulf War Veteran case by excluding RAC material, we discover a mysterious NIH P2P committee whose purpose is integrated in some way with the IOM contract.

    9. HHS’s insane and ludicrous insistence that the best people to decide a case definition are ‘non-experts’ including social behaviorists is tantamount as to allowing social behaviorists determine the case definition and treatment for heart disease. After all, some of the main components for heart disease are stress, poor nutrient, and exercise. So shouldn’t it be more fitting that treatment be placed in the hands of nutritionists and behaviorists overseeing a program of CBT/GET and healthy dieting.

    10. The flawed hypothesis or underlying premise that experts are biased toward their field would have to be extrapolated to every field of medicine to be consistent. So, let’s evaluate every sector of medicine.

    11. The purpose of these of this and other similar contracts is to reduce the costs for the health care industry and move vulnerable patients over to the psychogenic sector where health care coverage is almost non-existent. The new DSM-V manual is a prime example.

    12. Finally and most importantly consider the fact that ME/CFS expert’s experience at the low range over 1,200,000 million plus hours of research and treatment and the non-experts on the panel have, how many hours of experience in researching and treating ME/CFS patients…hmm?
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  10. Ember

    Ember Senior Member

    PANDORA seems to have made a mistake in their use of the term “chronic multi-system illnesses:”
    Under their heading, “What is Gulf War Illness,” PANDORA claims that “researchers and the U.S. Veterans Administration is referring to all of these as 'chronic multi-system illnesses.'" But their link shows instead that “VA refers to these illnesses as 'chronic multisymptom illness' and 'undiagnosed illnesses.'... VA is currently reviewing IOM's lastest report, Gulf War and Health: Treatment of Chronic Multisymptom Illness, released on January 23, 2013.”

    Perhaps PANDORA meant to write instead that "neuro-endocrine-immune diseases (NEIDs) are chronic multisymptom illnesses that take a dramatic toll on society, individuals and their families."
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  11. alex3619

    alex3619 Senior Member

    Logan, Queensland, Australia
    The IOM process of including non-experts in a review, though qualified in other areas, has good validity in the types of tasks for which the IOM has traditionally been contracted. That does not include disease definition reviews for diseases in which the evidence base is skewed and muddled. Its the wrong tool for the job.
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  12. Ren

    Ren .

    As I understand...

    CMI = chronic multi-symptom illness and NOT chronic multi-system illness.

    CMI (chronic multi-symptom illness) often has psychogenic overtones (in the literature);

    (However, VA has also written:

    Chronic multi-system illness is any chronic illness that affects multiple body systems. Lupus, for example, is a multi-system illness. No psychogenic overtones ever, I believe.

    These terms are easy to transpose. I've done it (and will probably do it again).

    ME is a chronic multi-system illness, but I agree with Ember above that PANDORA misquoted the VA. I've only seen VA describe ME/CFS as a CMI (chronic multi-symptom illness). PANDORA has confused these terms - not good for an advocacy group at all.

    My original purpose with posting here though was to call attention to Mike Michaud's (D-ME) (named above in post #8) involvement in current VA disability budget evaluation by CBO (Congressional Budget Office) - just to help keep track of members of congress and healthcare issues.

    Also of interest perhaps in this report is that page 3 states that compensable disability can be categorized as physical or mental. Page 13, however, has a footnote on "chronic, multiple-symptom illnesses" (naming CFS, fibro, IBS) and states that "VA has not made available data on remuneration for those conditions." - I'm not quite sure what this means though.
    (p.13, CFS = a CMI) / Veterans' Disability Compensation: Trends and Policy Options; CBO, August 2014.

    However, the above CBO doc includes references to: - the 2013 Code of Federal Regulations: Pensions, Bonuses, and Veterans' Relief.

    And as an fyi, chronic fatigue syndrome is listed as 4.88a under "Infectious diseases, Immune Disorders, and Nutritional deficiencies" (p. 378, p. 484). (Lyme disease is coded when acute, but thereafter, residual symptoms are classified under appropriate system - p. 429. I didn't find anything for multisymptom / multi-symptom.)
    Last edited: Sep 7, 2014
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