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Institute of Medicine (IOM) Review of ME/CFS Clinical Definition: First Open Meeting

Discussion in 'Phoenix Rising Articles' started by Phoenix Rising Team, Feb 13, 2014.

  1. Phoenix Rising Team

    Phoenix Rising Team

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    Gabby Klein provides a useful summary of what was a very important, and quite extensive, IOM open meeting. US Government representatives, patient organizations, advocates and individual patients all made formal presentations...

    [​IMG]
    Chair, Dr Ellen Wright Clayton,
    Committee for Diagnostic Criteria ME/CFS

    The Institute of Medicine (IOM) has been formally engaged by the US Department of Health and Human Services (HHS), to complete a review of diagnostic criteria and available evidence, for the purpose of making recommendations for a new clinical definition for ME/CFS, one that might also result in a new name for the disease(s).

    The first open IOM meeting was watched by ME/CFS stakeholders from around the world and representatives from our community made impressive presentations to the assembled committee. Extensive coverage of the speakers and presentations, as well as discussion about the issue, can be found in Phoenix Rising’s dedicated IOM section.

    However, it came to my notice that there are some patients who could not watch the meeting and others who have difficulty following all the many different threads and the volume of information this subject has attracted. So, it is with them in mind that I have attempted to give an organized overview as a more convenient place of reference, and to help ensure that greater awareness is raised of this important development and what it means to those involved.

    The IOM has chosen a panel of 15 experts to serve on the committee for the study. The committee is made up of 8 known ME/CFS experts who are best recognised by our community, as well as other experts with apparently no known experience with our disease. The composition of this panel has been a cause of concern for patients, advocates and other ME/CFS experts, who feel that a committee charged with defining a complex disease, like ME/CFS, should be made up entirely of those who have the best experience of diagnosing, treating and studying it.

    The meeting took place on January 27th, 2014. In attendance were the 15 committee members with Dr. Ellen Clayton as the Chair. The agenda called for presentations from four Government representatives. Dr. Nancy Lee, presented the “Background and Charge” to the IOM committee. Dr. Elizabeth Unger of the CDC followed with her overview of the CDC Multi-site Clinical Study. Dr. Susan Maier of the NIH expanded on the NIH Evidence-based Methodology Workshop (or P2P), and Sara Eggers concluded with the FDA “Voice of the Patient” Report.

    Seven patient organizations/advocates were invited to give seven-minute presentations each to the panel: Phoenix Rising, PANDORA Org., CFIDS Association of America, New Jersey Chronic Fatigue Syndrome Association, Massachusetts CFIDS/ME & FM Association, Wisconsin ME/CFS Association, Inc. and Occupy CFS. This was followed by a public session with 15 slots for in-person three-minute comments by patients, caregivers and advocates.

    A. Introduction

    1. The IOM Process

    by Rick Erdtman, Director, Board on the Health of Select Populations (BSP)

    Watch video here

    Rick outlined the key features in the process of any IOM study. He stressed the fact that this process is separate and independent from government agencies. There are no government appropriations given to the academy. Funds for studies come from the sponsors. There are four stages to IOM studies:
    The review process is structured to ensure that each report addresses its approved study charge and does not go beyond it, that the findings are supported by the scientific evidence and arguments presented, that the exposition and organization are effective, and that the report is impartial and objective.

    2. Formal Opening Remarks:

    by Ellen Wright Clayton - Committee Chair

    Watch video here

    Ellen welcomed all and read the agenda for the afternoon. She reminded us that this is only an information gathering session. That is, the committee is just beginning to assemble the material that they will examine and discuss in the course of making its findings, conclusions and recommendations. Comments from committee members should not be construed as positions.

    B. Presentations - Government Representatives:

    3. IOM Contract Background and Committee Responsibilities:

    by Dr. Nancy Lee, M.D., Designated Federal Officer for the Chronic Fatigue Syndrome Advisory Committee (CFSAC); Deputy Assistant Secretary for Health - Women's Health and the Director of the Office on Women's Health (OWH) in the Office of the Secretary, U.S. Department of Health and Human Services (HHS)

    Read it here

    Watch the video here, Q&A session here

    See the slides here

    Dr. Nancy Lee outlined the task at hand to the IOM committee. This was the meat of the whole meeting since all the work this panel will be conducting will be based on this charge from HHS. It was an elaboration on the Statement of Work (SOW) which HHS had previously provided.

    Nancy reiterated that this IOM committe is a direct result of CFSAC 2012 recommendation to the Secretary of HHS, that a workshop be convened to reach a consensus for clinical (and research) definitions for ME/CFS.

    (Ominously, Nancy neglected to mention that the actual recommendation from CFSAC called for only ME/CFS experts, patients and advocates to do the work, and it had insisted that the starting point of any review should be the Canadian Consensus Criteria (CCC).)

    The charge to the IOM committee is as follows:
    • Conduct a study of the various diagnostic criteria for ME/CFS
    The specific criteria outlined to be studied are the 1994 Fukuda (not mentioned in the SOW), the 2003 Canadian Consensus Criteria, the 2007 NICE Guideline, the 2010 revised CCC and the 2011 International Consensus Criteria.​
    • Develop evidence-based criteria using consensus building methodology
    The method to be used is an evidenced-based review of published peer-reviewed research relating to biomarkers, pathology and epidemiology, as well as a review of literature pertaining to the symptoms of the disease. They are to identify unexplained chronic fatigue, generalized chronic fatigue (with known etiology), and the more specific myalgic encephalomyelitis (ME). The study should include consideration for sub-populations like children and determine where identified subsets are to fit under the broad umbrella of ME/CFS.​
    • Recommend new terminology, if needed
    The issue of whether ME and CFS are the same disease or different entities needs to be addressed and if there is a need for separate terminologies.​

    Nancy went on to state, “Please know that there are many people – scientists, clinicians, advocates – who believe that the name Chronic Fatigue Syndrome does harm to patients. I agree.”​
    • Develop outreach and dissemination to clinicians
    The panel is finally tasked with disseminating the recommendations to clinicians across the country, and to also recommend strategies that will result in an increased number of doctors who can both recognize and diagnose ME/CFS.​

    4. Methodology for CDC Multi-site Clinical Study:

    by Dr. Elizabeth Unger, M.D., Chief of the Chronic Viral Diseases Branch (CVDB), Centers for Disease Control and Prevention (CDC)

    Watch the video here, Q&A session here

    See the slides here

    Read the recent Phoenix Rising interview with Beth Unger here

    Beth Unger provided us with an overview of the ongoing CDC multi-site study. She outlined the difficulties in doing research for such a complex and heterogeneous disease, and the added confusion of having several different diagnostic criteria only compounds the issue.

    In order to properly conduct this study, CDC decided that they needed to capture the disease as carefully as possible. Therefore, they decided to use the expertise of physicians who have cared for ME/CFS patients to determine if a patient qualified for the study, rather than select patients based on any specific criteria.

    Unger discussed Phase One of the study, which featured standardized data collection from the seven ME/CFS experts’ clinical sites that had been chosen. A physical exam at the clinic for each patient in the trial was included as well as responses from several patient questionnaires.

    These questionnaires were used as measures for functioning, fatigue, sleep, mental health and pain. They also included a symptom inventory that revealed the most troubling symptoms recorded were post-exertional malaise (PEM), unrefreshing sleep, and memory/concentration problems.

    The overall patient demographics show an average age of 48.2. Of the total patients in the study, ¾ were female, 90% were white, 77% were college educated and ¾ were not working. This patient population showed a 65% sudden onset to the disease. The duration of the illness in these patients varied from 2.5 to 52 years!

    The results from a Promis T-score questionnaire from the ME/CFS patients were compared with patients suffering from five different diseases. ME/CFS patients showed higher scores for fatigue, pain and sleep disturbance on their Promis T-scores compared to patients suffering from five other diseases, including multiple sclerosis and muscular dystrophy.

    5. NIH Evidence-based Methodology Workshop/P2P:

    by Susan Maier, Deputy Director, Office of Research on Women’s Health (ORWH), U.S. Department of Health & Human Services (HHS)

    Read it here

    Watch the video here, Q&A session here

    See the slides here

    Susan Maier walked us through the process of NIH’s Pathways to Prevention (P2P) program which is the new name for the Evidence-based Methodology Workshop (EbMW). This program was developed out of a need for a process that could be implemented in approximately a year, and addresses topics with methodological weaknesses.

    P2P workshops are designed for topics that have incomplete or underdeveloped research, difficulty producing a report synthesizing published literature, and are generally not controversial. The NIH Office of Disease Prevention (ODP) provides the leadership, infrastructure, funding, and coordination necessary to conduct P2P workshops.

    In January of this year, the first meeting of the Workshop Working Group took place. It consists of ME/CFS expert clinicians and researchers, patients, advocates, and caregivers, as well as federal partners [the actual members of this working group remain secret]. Their charge is to prepare the way for the panel [of non-experts] who will actually do the review. The duty of the Working Group is to refine the questions for the evidence review, develop the workshop agenda and to then nominate panel members.

    The panel members doing the review will include highly respected individuals in their field such as medicine, law, health research, public representatives. They can’t be government employees or ME/CFS experts. The panel members should have no preconceived opinions or bias [in fact, they will be ignorant] regarding ME/CFS.

    Susan went on to compare this panel to a jury of your peers in a court case. They are to hear all the sides and then deliberate the decision. [Many patients and advocates were troubled by the use of this example: For a disease as complex and misunderstood as ME/CFS, we need the “supreme court” of expert judges to determine the outcome - as outlined by the actual recommendation from CFSAC 10/12]

    The following questions have been created by the workshop group at the first meeting:
    • Do ME and CFS differ?
    • How to uncover subsets of individuals in the spectrum of ME/CFS? Which tools will be used for this purpose?
    • Which patients respond to specific treatments? What is the mechanism of action to these treatments. What tools will find these patients?
    • What do we learn from clinical research that could be applied to diagnosis of the disease?
    • Should research and clinical practice be completely separate in ME/CFS? Do co-morbidities help define subsets?
    • How do ME and CFS differ? Are they the same, overlapping or separate entities?
    The Q&A session revealed that there are two members on the IOM panel who are also serving on the NIH P2P workshop. Dr. Nancy Klimas is certainly one of them, and she appeared confused over the exact nature of sharing and how the information should flow between these two committees. Unfortunately, the replies from Susan were not very clear, and so some confusion would seem to remain.

    6. FDA ‘The Voice of the Patient’ Report:

    by Sara Eggers, Office of Program and Strategic Analysis/Office of Strategic Programs, Center for Drug valuation and Research, U.S. Food and Drug Administration (FDA)

    Read it here

    Watch video here

    See the slides here

    Sara Eggers reported on ‘The Voice of the Patient’ document produced by the FDA that was based on their CFS and ME Patient Focused Drug Development Meeting which took place in April 2013.

    Some of the points that FDA learned from patients at that meeting included:
    • CFS and ME is much more than simply fatigue
    • The disease can take a devastating toll on patients and families
    • Patients use a complex regimen of drug and non-drug therapies to treat the disease
    • Patients are desperate for research and development into treatments for the disease
    • Many patients can pinpoint the exact time of onset of their symptoms
    Various symptoms were described as follows:
    • Fatigue: drained, tired-but-wired, and bone-crushing
    • Sleep Dysfunction: insomnia, unrefreshed sleep, sleep disruptions
    • Pain: muscle, joint, eyes, neck, nerve, headache migraine and whole body
    • Cognitive impairment: brain fog, impaired executive function, disorientation, inability to process information, slowed reaction time, impaired memory, inability to find words, spacial disorientation
    C. Presentations - Patient Organizations/Advocates

    The patient organizations and advocates were invited to give a presentation based on the following question:

    “What is the most important aspect or information that this committee should consider throughout the course of the study?”

    The following are brief overviews of the presentations. I suggest that when you have time, you read/listen to each presentation as they all individually add value to the cause.

    7. Phoenix Rising:

    by Gabby Klein - Phoenix Rising Member/Advocate

    [​IMG]
    Read it here

    Watch the video here

    See the slides here

    Phoenix Rising wanted to compose a presentation which is reflective of the views of its members. In that vein, Mark Berry started a thread on the PR forum asking members to identify what they would like the panel to hear. A small group of volunteers worked on putting together this presentation based on the summary of members’ comments on the thread.

    They identified four points of focus:
    1. ME is an organic, complex, seriously disabling disease
    2. ME needs a definition at least as strict as the CCC or ICC
    3. ME is not a psychogenic somatoform illness
    4. Myalgic encephalomyelitis (ME) should be the term used for the disease
    What ME is:

    ME as described by the CCC, has a distinct and definable nature. It best describes the members’ complex and specific symptoms of muscular and neurological dysfunctions. It has the hallmark prerequisite symptom of post-exertional malaise (PEM). ME, therefore, should be separated out from the broad fatigue-based definitions.

    There are testable biomarkers, such as the two day cardiopulmonary exercise testing (CPET) which captures PEM, natural killer cell and immune dysfunction in blood tests. Cerebrospinal fluid and structural MRIs have revealed neurological abnormalities.

    What ME is not:

    Terms previously used to describe the syndrome CFS, such as “depressive mood”, “deconditioning”, “somatoform”, “personality disorder”, “childhood abuse”, “hypochondria”, “laziness”, “malingering” , or “unwellness” do not apply to the organic disease of ME. Since ME is an organic disease, any research into ME as a psychological, psychogenic or functional disorder should be disregarded. Other illnesses such as asthma, stomach ulcers, multiple sclerosis, and inflammatory bowel disease have been thought as “psychosomatic” until a known and identifiable physical element was discovered.

    The presentation concluded with the fact that many members have expressed concerns about this study, including and especially the fact that many members of the panel, as currently constituted, lack appropriate expertise in the treatment or diagnosis of this disease. Many would like us to adopt the CCC now and call for a cancellation of this unneeded study.

    8. PANDORA Org.:

    by Lori Chapo-Kroger – President and CEO

    Read it here

    Watch the video here

    See the slides here

    Lori presented the complexities and difficulties with ME/CFS. There are too many definitions obscuring diagnosis of the disease. There is currently no specialty for ME/CFS and there is a great lack of physician education. The confusion is compounded by the problem of having two separate ICD-CM codes. Chronic fatigue syndrome denotes a common symptom; it does not describe a disease. For all these reasons, 84% of patients are misdiagnosed or not diagnosed and there are no FDA-approved drugs.

    “When looking at research in your study”, Lori adds, “we recommend you reject all research that focused on or only requires chronic fatigue. Those studies don’t inform you on our illness, they inform you on a symptom of many diseases.”

    She stressed the importance of identifying the disease, not just the symptom. Fatigue does not identify a disease. It is subjective and can result from virtually every physical and psychological illnesses or by healthy people. ”We need you to create a definition for our disease that easily distinguishes ME from primary depression, idiopathic fatigue and other organic diseases.”

    9. CFIDS Association of America:

    by Carol Head- President and CEO

    Read it here

    Watch the video here

    See the slides here

    Carol spoke about the need to develop effective treatments for ME/CFS. The lack of uniformly-accepted clinical diagnostic criteria has caused confusion, and has impeded progress towards that goal.

    The CFIDS Association conducted a survey of patients. Out of 256 responders, the majority saw more than four doctors in a time frame of years before getting a diagnosis of ME/CFS. This delay in diagnosis has resulted in lack of treatment and worsening of the patient’s condition.

    “Over and over again, patients told us stories of delayed diagnosis, lack of treatment, a need to educate the doctor, increased disability and even hostility due to physician lack of knowledge and empathy. Patients spoke of the unfortunate ignorance of some in the medical community.”

    Good clinical diagnostic criteria will lead to biomarker discovery. This is currently shown in a SolveCFS study of 100 genes, where ME/CFS patients using the CCC have clearly delineated from healthy controls.

    10. New Jersey Chronic Fatigue Syndrome Association:

    by Pat LaRossa – President

    Read it here

    Watch the video here

    See the slides

    Pat took on the challenge of properly naming our disease. She described a picture of a tomato by calling it the “Edible Red Thing”. “There are many edible and red things. If you include them all, will you learn what you need to know about the specific red edible?”

    The problem arises when one feature or symptom that is shared by many is used to describe a very complex disease. Fatigue is a very broad term, whereas ME describes a specific disease. Yet, many ME/CFS studies use criteria that could include people who suffer from ‘fatiguing illnesses’, and do not have ME/CFS. The name myalgic encephalomyelitis has been accepted internationally, including by the World Health Organization (WHO). The 2011 International Consensus Criteria rejects the name ME/CFS for the singular name ME.

    She brought up the issue of different diagnostic coding for the disease that has compounded the problem. These codes affect medical care and insurance benefits. There is the danger that ME/CFS might get the coding of a psychiatric diagnosis in the new Psychiatric Diagnostic Manual 5 (DSM-5).

    11. Massachusetts CFIDS/ME & FM Association:

    by Charmian Proskauer – President

    Read it here

    Watch the video here

    See the slides

    Charmian spoke on behalf of children and adolescents suffering from ME/CFS. Her organization works extensively to educate school nurses about how to recognize ME/CFS in children and adolescents. This is made difficult by the fact that like with adults, the symptoms can wax and wane. This can be confusing because the child might be fine in the morning and sick after lunchtime. A pattern of variable symptoms over time may be an indication of ME/CFS.

    "CFS is the most frequent cause of prolonged absence from school, and it is this prolonged absence that often leads school officials down the wrong path of falsely labeling ill children with 'school phobia' or taking the parents to court for Medical Child Abuse. Children with ME/CFS want to go to school — and will tell you that if you ask them!”

    12. Wisconsin ME/CFS Association:

    by Mary Schweitzer – Advocate/blogger, Slightly Alive

    Read it here

    Watch the video here

    Mary Schweitzer took us on a walk of the history of the disease:
    • 1934 -ME was known as ‘atypical polio’.
    • 1969 - It was classified in Neurology by WHO
    • 1980’s - Clusters of the disease resulted in the initial name of ‘chronic Epstein-Barr virus’ (CEBV)
    • 1986 – Stephen Strauss coined the name CFS. He decided that the disease was due to depression and/or stress. This resulted in paltry funding from the NIH for the next three decades going mainly to studies into "fatiguing" illnesses.
    • 1994 – Congress asked CDC to do a study on children and adolescents with this disease. CDC spent the money on another project entirely, and got in trouble with Congress. The money was reinstated, but not the projects. Dr. William Reeves, in charge of CFS at CDC, explained that he didn’t think enough school-aged children and teenagers got the disease to be worth a study.
    • 1999 – Leonard Jason and a team at DePaul estimated that roughly 800,000 American adults probably had the disease, and the disease was equal opportunity – all income groups, all ethnicities. This estimate has been in use ever since – today, the DePaul estimate would put the number of patients closer to 1.3 million.
    • 2003 – Canada adopted its version of ICD-10, which included CFS, with ME, in neurology. A committee was convened of clinician experts, including several from the US. The result is called the Canadian Consensus Criteria (CCC) and does an admirable job of capturing the complexity of this illness.
    • 2004 – CFSAC recommended to the secretary of HHS that the US adopt the Canadian Consensus Criteria. The recommendation was repeated again two years ago – but HHS’s response was to convene this IOM committee.
    Mary continues with: “I am here to ask you not to repeat the errors of the past: Dig Deeper.”

    Please listen/read the entire presentation it is full of crucial information.

    13. Occupy CFS:

    by Jennie Spotila – Advocate/blogger, OccupyCFS

    Read it here

    Watch the video here

    See the slides

    Jennie’s title of her presentation was “Accurate and Precise”.

    She outlined the challenge to the panel of creating diagnostic criteria for a disease with conflicting case definitions, no gold standard biomarkers, and competing views about how to define the problem. There are many potential pitfalls such as the high prevalence of the symptom of chronic fatigue in the general population and the effects of competing case definitions on research results

    The way to overcome these challenges is by being accurate and precise. To accomplish this, there is a need to set aside the fatigue umbrella and focus on the core symptoms of this disease. Frequency and severity threshold requirements need to be established.

    If the panel recognizes that their diagnostic criteria will be part of an iterative process of refinement, then they will be able to create diagnostic criteria that will advance clinical care and then research, instead of putting us further behind: a definition that is sensitive and specific for ME/CFS is what is required.

    “. . and never lose sight of the very high stakes we face.”

    D. Public Comments

    The following excellent public comments resulted in a strong unified voice of opposition to this study. Many are calling for a cancellation of the contract and the adaptation of CCC. Please listen to each and everyone. I will just choose a small excerpt here from each, as highlights.

    14. Jeanette Burmeister

    Video here

    Written statement here

    “I’ve heard some people at HHS are confused about patients’ deeply-felt opposition to your project. Let me explain in simple terms why:

    · HHS hired an institution without experience or authority to develop case definitions.
    · An excellent case definition, based on science, already exists and the experts endorsed it.
    · The IOM has a fatal organizational conflict of interest. I have filed a complaint with the Office of the Inspector General. A formal investigation is under way.
    · HHS has broken federal law as to FOIA compliance. 2.5 weeks ago, I filed a lawsuit against HHS and NIH in U.S. district court.”

    15. Mary Dimmock

    Video here

    Written statement here

    “Dr. Chris Snell said that, with using Cardio-Pulmonary Exercise Testing (CPET), you can actually distinguish between patients with ME and patients with depression, deconditioning and a number of other chronic illnesses. Yet, there’s a lot of confusion in the medical community. Why is that? The reason is because for 30 years we have used definitions that fail to require these hallmark symptoms like PEM. We currently allow patients to have any combinations of four out of eight symptoms of Fukuda. Lenny Jason has shown how we end up with depression, deconditioning and other unexplained fatiguing illnesses."

    16. Joan Grobstein

    Video here

    Written statement here

    Joan outlined several difficulties with this study process, such as:

    “Unfortunately, the evidence base for ME/CFS has been adversely affected by two factors: lack of research funding and a multitude of definitions of the disease. ME/CFS receives approximately 6 million dollars per year in most years. Compare this to the billion dollars per year that has allowed AIDS patients to lead essentially normal lives. Because of poor funding, none of the definitions are particularly well-supported by research and many aspects of the disease – multiple infections, immune and mitochondrial dysfunction, and orthostasis – have not been adequately studied. Large, well-powered studies are rare. And, because there are overly broad definitions of 'CFS' that include many patients who don’t have ME, there are studies in the literature that do not apply to ME patients at all.”

    17. Eileen Holderman

    Video here

    Written comment here

    “The majority of stakeholders oppose the contract for many reasons, and it’s evidenced by the letter and call campaigns, twitter campaigns, the congressional calls and meetings, the two petitions, the demonstration, the media interviews, legal actions, Freedom of Information Acts, the advocates’ letters signed by 171 advocates, and the ME/CFS expert letter. Fifty ME/CFS experts, researchers and clinicians, got together — they wrote a letter and they sent it and mailed it to Secretary Sebelius, and in that letter they said: “We, the experts have developed a definition, the Canadian Consensus Criteria, to describe ME/CFS. We’re using it, we've been using it, and we’re committed to refining it. Now we want the government to use it.””

    18. Anne Keith

    Video here

    Written statement here

    “The basis of medicine is ‘premum non nocere’ – first, do no harm. It is the underlying principle of all medicine drilled in medical students for a very good reason. Medicine beyond any other field has the greatest potential for harm. Harm is not necessarily determined by intent, effort or education. ‘Premum non nocere’ is a reminder that it is important to evaluate and mitigate both, potential obvious and hidden harms. It takes courage to speak up and say that something should be done differently or not done at all. This simple demonstration will show why HHS’s request to consider using multiple definitions to come up with a new definition puts you in a position of needing to have that courage and insight.”

    19. Mindy Kitei

    Video here

    Written statement here

    “Patients believe that the IOM will devise a name worse than chronic fatigue syndrome, something like “chronic multi-symptom illness,” the meaningless moniker the government and IOM use for Gulf War Syndrome. On the IOM website, a curious diagram that accompanies an article by Dr. Daniel Clauw, lists several diseases: Gulf War Syndrome, fibromyalgia and CFS, among them, all covered under the big umbrella of somatoform disorders, psychiatric ailments that just look like physical diseases.”

    20. Susan Kreutzer, for mecfsforums

    Video here

    Written comments here

    “Perhaps mecfsforums was not invited to present because a forum administrator, Patricia Carter, created the Petition to 'Stop the HHS-IOM contract and accept the CCC definition of M.E.' on October 7, 2013. This petition now has more than 5000 signatures.”

    Petition: https://secure.avaaz.org/en/petition/Stop_the_HHSIOM_contract_and_accept_the_CCC_definition_of_ME/

    “The Petition to 'Stop the HHS-IOM Contract and Accept the CCC Definition of M.E.' is solid evidence of the position of thousands of ME/CFS stakeholders on the contract HHS has made with the Institute of Medicine to define ME/CFS – and these thousands of patients and friends oppose this contract.”

    21. Joe Landson

    Video here

    Written comments here

    “The most important issue for the committee to consider is the unintended consequence of diagnostic criteria based on symptoms alone. To that point, I would like to recommend a book. The book is called Brain on Fire by Susannah Cahalan ... she (Susannah) recovered because she had a treatable autoimmune disease that looked exactly like mental illness. Most of her doctors thought she was just plain crazy. Only one doctor believed Susannah’s normal personality was still inside her twitching, emaciated body.”

    “For decades, we too have had symptoms that seem psychiatric. For decades, we too have taken tests that showed nothing. For decades, researchers pursued psychiatric models of our disease, but failed to explain its precipitance, its severity or its persistence.”

    22. Denise and Matthew Lopez-Majano

    Video here

    Written statement here

    “I want to address 2 hallmark symptoms of this illness and then highlight five points about the process you will use.

    “Number 1 Post-Exertional Collapse (unfortunately known also as Post-Exertional Malaise (PEM))

    “Post-Exertional Collapse can result from minimal physical or cognitive exertion, is unpredictable and lasts for days or weeks. The pervasiveness of Post-Exertional Collapse often has no correlation with the minimal exertion of the triggering event.

    “Number 2 Impairment of Executive Function

    “Impairment of executive function is evident in areas such as processing speed, reaction time, working memory, and concentration. These impairments have been reported as significant concerns both in research and in reports such as FDA’s Voice of the Patient .”

    23. Jay Spero, for Dr. Derek Enlander

    Video here

    Written statement here

    “I was honored and pleased to have been asked to sign what has become known as the ‘Experts’ Letter’, where several dozen colleagues have expressed opposition to possibly altering or redefining the criteria of M.E. & C.F.S. by virtue of the pending IOM contract. If it was the case that there was opposition to the existing Canadian Consensus Criteria, then open discussion about these criteria would be more useful than closed door redefinition by a panel where the majority are not known to be familiar with the disease, Myalgic Encephalomyelitis.”

    24. Maryan Spurgin, read by Charlotte Von Salis

    Video here

    Written statement here

    “There are more than 500 papers in the medical literature that show measurable physiological abnormalities in the melting pot of 'CFS'. These papers show a pathophysiology for all three of the essential components of the M.E. criteria that Dr. Melvin Ramsey described: circulatory, immune, and muscle impairment. Articles describing all of these pathophysiologies in M.E patients, although published under the name 'CFS', are available on my website. "

    25. Charlotte Von Salis

    Video here

    Written statement here

    “Your task, to develop clinical diagnostic criteria for ME and CFS, has already been accomplished. Two primers, specifically aimed at clinicians unfamiliar with the diseases, are already available. Both are based on criteria developed by disease experts and published in peer-reviewed medical journals. Both are available as easy -to-distribute pamphlets. I am referring to the Overview of the Canadian Consensus Criteria and the ME-ICC Primer for Medical Practitioners. The latter is an update of the former to reflect scientific developments through 2011.”

    Postscript - Gabby Klein

    Many strong presentations were made at this meeting. There was a common thread in circulation describing the complexities of the disease, the frustrations with the history of the disease, the lack of understanding and the marginalizing of the disease by government representatives. This is a patient community that is seriously ill and totally beaten down from long-term neglect. One can hear this frustration in the voices of the commentators. I was stoked by their intelligence and eloquence. I only hope that the panel members took each and every word to heart.

    The reality remains though that I and a large group of patients and advocates still feel that this study should not take place. For all the reasons stated by the presenters, this study is doomed to fail. I wish that HHS would have truly listened to their own advisory committee members and had convened a workshop of ME/CFS experts in order to work on the definition, and had started with the Canadian Consensus Criteria. We already have this as a diagnostic definition that our experts have adopted. The problem is that HHS has refused to give it legitimacy.

    So many questions still remain:
    • Why are there simultaneously three endeavors by HHS, seemingly doing very similar things? The IOM study, the P2P workshop and the CDC multi-site study.
    • Are these three to work together in synergy as Nancy Lee stated in her charge? Or, are we to accept Ellen Clayton's words that the sponsor (HHS) may not have any input into the IOM process?
    • Why has the HHS/IOM contract not been produced by HHS to the advocates who filed FOIA requests for it?
    • In what way will the P2P non-expert panel influence the outcome of the new clinical definition? The function of P2P has not been made clear. Susan Maier says that its duty is not to produce a research definition, but isn't this is what NIH does, produce research? And so surely the results might be used for a research definition. Is this official NIH doublespeak?
    • Why has HHS and the IOM not listened or replied to all the comments by patients and advocates urging for a committee of only experts to define this complex disease? They say that they value input by patients and advocates, and yet, there is nothing to support that statement. In addition, I have just learned that all comments that were supposed to go to a public docket are not accessible by the public. If you want to read these public statements, you have to order and pay for them!
    If you would like to join the discussions here at Phoenix Rising regarding all the aspects of this IOM study, then please see the special IOM forum section here.


    Phoenix Rising is a registered 501 c.(3) non profit. We support ME/CFS and NEID patients through rigorous reporting, reliable information, effective advocacy and the provision of online services which empower patients and help them to cope with their isolation.

    There are many ways you can help Phoenix Rising to continue its work. If you feel able to offer your time and talent, we could really use some more authors, proof-readers, fundraisers, technicians etc. and we’d love to expand our Board of Directors. So, if you think you can help then please contact Mark through the Forum.

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    View the Post on the Blog
     
    Last edited by a moderator: Feb 13, 2014
    Nico, ahimsa, AzizaJ and 9 others like this.
  2. Legendrew

    Legendrew Content team

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    Thank-you Gabby for not only this thorough evaluation of the Meeting overall, but also taking the helm of the Phoenix Rising presentation. While this topic has a whirlwind of controversy surrounding it it sounds like this is going in the right direction at the moment which is all we can hope for.
     
    ahimsa, AzizaJ, Esther12 and 3 others like this.
  3. Snowdrop

    Snowdrop Senior Member

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    RE: So Many Questions Still Remain.

    Indeed.
    Lets keep these questions out there where the government is faced with them.
    Reiterated again and again.

    It has stopped being surprising how well respected, well heeled, well educated people can damn us to hell while feeling good about themselves. They believe they are helping simply by talking the talk ~ no need to actually DO the right thing.
     
    AzizaJ, Esther12 and Nielk like this.
  4. apogan

    apogan

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    Thank you for all your hard work on this, Gabby. It helped so much to see the meeting laid out in this format.
     
    Firestormm, Esther12 and Nielk like this.
  5. Ren

    Ren Primum Non Nocere

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    Thank you so much, Gabby! This is a HUGE document. Too much for my brain - and probably numerous others - to digest in a period where we could truly advocate for ourselves, which I believe is a further form of abuse/discrimination since those who are least able are those who are most silenced by IOM/HHS/SSA's* dictated communication mediums and scheduling.

    *For what it's worth, and I'm not sure how this should be referenced, but the ME/CFS IOM page cites the funding parties as both HHS and the Social Security Administration. http://www.iom.edu/Activities/Disease/DiagnosisMyalgicEncephalomyelitisChronicFatigueSyndrome.aspx

    Thank you, again!:balloons:
     
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  6. Nielk

    Nielk

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    Thanks.

    As far as who the sponsors are exactly is still a mystery. I know that the IOM page list. HHS and SSA but Nancy Lee said that most if the government agencies who deal with ME/CFS have contributed in the funding of the study. In order to really clarify this, we would need a copy of the contract which has not been supplied even though there have been at least three FOIA requests.
     
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  7. Marylib

    Marylib Senior Member

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    Thank you Gabby.
     
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  8. taniaaust1

    taniaaust1 Senior Member

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    You write so well.. and managed to put that together in a manner which is easier for us to get throu. I applaud you for that. I think this article was so needed.

    Thanks
     
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  9. Firestormm

    Firestormm Guest

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    Morning :)

    Gabby did such a good job on this one. What a complex meeting it was. Even with such a nice and clear summary, it is one of our longer articles.

    If you haven't already noticed, there is an interactive content menu on the Blog/Home Page version, situated just beneath Gabby's opening introduction.

    Unfortunately, it wasn't possible to have this feature on the forums version.

    Fire
     
    Last edited: Feb 14, 2014
    aimossy, Simon and Nielk like this.
  10. Womble

    Womble

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    I have very limited energy, so I ask:

    Should I watch these videos, do they have any practical treatment recommendations for those who suffer from CFS/ME?

    Or is it more just interesting and informative but not a MUST WATCH?
     
  11. Firestormm

    Firestormm Guest

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    Hi @Womble not really much point watching any if you are looking for talk about treatments. Certainly the meeting was interesting and informative and a must watch from those perspectives :)
     

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