My Feedback to the Institute of Medicine

Today, I submitted the following letter to the Institute of Medicine with my feedback on the panel for the Diagnostic Criteria for ME/CFS. Seven other advocates signed the letter: Chris Heppner, Claudia Goodell, Joe Landson, Denise Lopez-Majano, Matina Nicholson, Darlene Prestwich, and Tamara Staples.

Thank you for this opportunity to provide feedback on the Institute of Medicine’s provisional committee appointments for the Diagnostic Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. In order to understand the significance of my concerns, I believe you must first understand the damaging legacy of the psychogenic view of ME/CFS. Then I will share my specific feedback about the panel’s composition.

Legacy of Psychogenic Explanations for ME/CFS

For more than thirty years, the psychogenic model dominated the medical mainstream view of ME/CFS. Patients were labeled malingerers with “yuppie flu.” Allegedly, they could not cope with stress, indulged their psychosomatic symptoms, received secondary gain from disability, and simply needed to get therapy and more exercise. I have never met an ME/CFS patient who did not receive this message from at least one doctor.

Through the 1990’s, science seemed to confirm this model. Every investigation for a causative infectious agent failed. Contradictory results prevented the validation of diagnostic biomarkers. And psychologists published data showing that cognitive behavioral therapy and graded exercise therapy produced positive outcomes.

But ME/CFS patients, expert clinicians, and some researchers knew that the data were flawed. Mixed patient cohorts likely contributed to many of the contradictory results. Many of us followed the advice of well-meaning healthcare providers and tried to exercise ourselves out of disease. This therapy was not a treatment, and adverse side effects included relapse, exacerbation of the disease, and increased disability.

Science soon emerged to confirm what we knew empirically. Studies showed that ME/CFS patients have different physiological responses to activity as compared to multiple control groups.(1) Many body systems are implicated in the causation and perpetuation of ME/CFS. Field-testing of multiple case definitions measured what we already knew to be true: that some case definitions incorporated people with primary psychological conditions like depression, along with missed cases of multiple sclerosis, lupus, thyroid disease and primary sleep disorders. (2) Given the ample data showing physiological differences between ME/CFS patients and patients with depression and other illnesses, the inclusion of subjects with primary depression in CBT and GET trials is a fatal flaw in study design.

The psychogenic model of ME/CFS should have faded into obscurity by now. But it persists in open supporters of the hypothesis, and in less overtly expressed attitudes among scientists, doctors, and policy makers. Our long experience with the destructive effects of psychogenic pronouncements has taught us to be wary of these unseen and unvoiced assumptions.

Insufficient Representation of Subject Matter Experts

I acknowledge the selection of seven well-known and well-regarded ME/CFS experts to the panel. I am confident in their individual and collective abilities to examine the data and share their experience with the full group. However, given the nature of the panel’s task, I believe that more ME/CFS experts should be added to the panel.

In creating “evidence-based clinical diagnostic criteria for ME/CFS for use by clinicians,” the panel needs both fresh examination of the data by outsiders and consideration of the collective experiential knowledge of those who know this disease. Research and clinical care in ME/CFS has typically been small-scale and distributed widely among the people doing this work. Only when a critical mass of experts combines their knowledge, such as at the NIH ME/CFS State of the Knowledge Workshop in 2011, do the disparate themes come together in a cohesive picture.

My concern is not a numbers game with the goal of reaching a certain percentage of representation. The panel is missing key expertise:

  • First, the absence of a cardiologist is notable. While Drs. Keller, Lerner and Rowe have relevant experience, dysautonomia is too prevalent in ME/CFS for it to be only marginally addressed. Adding a panelist with expertise in postural orthostatic tachycardia syndrome, vasovagal syncope, and/or neurally mediated hypotension is appropriate. I suggest Julian M. Stewart, M.D., Ph.D. or Marvin S. Medow, Ph.D., both at the Center for Hypotension, New York Medical College.
  • Second, there is only one infectious disease specialist on the panel. This is a significant gap in expertise, given the unsuccessful hunt for a causal pathogen in a disease that has all the hallmarks of an infectious trigger. Dr. Martin Lerner is capable, but I suggest adding at least one more infectious disease specialist. Ian Lipkin, M.D., is Director of the Center for Infection and Immunity at Columbia University. An epidemiologist by training, Dr. Lipkin is known for detection of new pathogens and the role of infection in neurologic diseases. He also has experience in ME/CFS-related research. Another candidate to consider is Jose G. Montoya, M.D., Director of the Stanford ME/CFS Initiative and Professor of Medicine in Infectious Disease at Stanford University Medical Center. Dr. Montoya is a clinician-researcher in ME/CFS and also studies the role of infection in chronic disease.
  • Third, as the FDA recognized in their Voice of the Patient report, cognitive problems are a prominent part of ME/CFS. Gudrun Lange, Ph.D. of Beth Israel Medical Center is an expert in cognitive dysfunction in ME/CFS, and would be a strong addition to the panel.

Finally, the absence of psychologist Leonard Jason, Ph.D. from the panel is very troubling. As I am certain you are aware, Dr. Jason has done more work on field-testing ME/CFS case definitions than any other individual. His publications have demonstrated the inadequacies of the Fukuda and Oxford definitions, the correlation between more symptoms and psychopathology in the ME-ICC definition, and have shown that measuring frequency and severity of symptoms distinguishes patients with ME/CFS from those with fatigue alone. (3)

I recognize that one or more of the individuals I am recommending may be unwilling or unable to serve on the IOM panel. I urge you to harness their expertise in other ways. This is particularly true for Dr. Jason. If he cannot serve on the panel, I believe it is essential that he be invited to present to the committee and that his work be a significant part of the panel’s deliberations.

Investigating Bias in Three Panel Members

I believe that three members of the provisional panel may have bias that would preclude their service on the committee. I understand that the IOM’s Conflict of Interest policy bars individuals with bias from panels only when “unwilling, or reasonably perceived to be unwilling, to consider other perspectives or relevant evidence to the contrary.” (IOM Conflict of Interest Policy, p. 4). I also acknowledge the difficulty of assessing bias at a distance. Therefore, I request that IOM discuss and thoroughly consider the potential biases of these three panelists.

First, Dr. Margarita Alegria co-authored a paper on the prevalence and comorbidity of neurasthenia.(4) While this paper did not directly examine the potential overlap between ME/CFS and neurasthenia, I am troubled by the statements on page 1742 that CFS is “a controversial illness which has been argued to be a variant of neurasthenia,” and that individuals “may present with symptoms of neurasthenia, but may otherwise be misdiagnosed as having depression, anxiety, or CFS.” If Dr. Alegria believes that ME/CFS is actually a psychological condition such as neurasthenia, then her presence on the panel is unacceptable. I urge IOM to establish whether Dr. Alegria has such a bias, and remove her from the panel if she does.

Second, Dr. Theodore Ganiats has close ties to the American Academy of Family Practitioners. The AAFP has published inaccurate and incomplete material about ME/CFS as recently as 2012. (5) In fact, the AAFP’s material on CFS illustrates the outdated and incorrect view of ME/CFS that I discussed above, including the claim that childhood trauma raises the risk of the disease and that CBT and GET are effective treatments. (6) Furthermore, one of Dr. Ganiats’s close colleagues, Dr. William Sieber, has given presentations in which he has stated that CFS is caused by psychological problems. (7) IOM should establish whether Dr. Ganiats shares this psychogenic bias and whether he can truly consider the evidence to the contrary.

Third, Dr. Cynthia Mulrow led the last systematic evidence review on chronic fatigue syndrome conducted by the Agency for Healthcare Research and Quality in 2001. Her report stated, “The validity of any definition is difficult to establish because there are no clear biologic markers for CFS, and no effective treatments specific only to CFS have been identified.” (8) If Dr. Mulrow still believes that this is the test for establishing the validity of a definition, then she is not appropriate for this panel. The lack of “clear” biomarkers and specific effective treatment is due to the paucity of research funding. Many promising biomarkers and treatments need only sufficient investment to establish their validity. Furthermore, Dr. Mulrow’s 2001 article on the treatments for CFS states that there was no significant association between case definition used and treatment study outcome. (9) We now know that some case definitions select patients with psychological problems at a higher rate than others, and this must be accounted for in the panel’s analysis. Absence of evidence is not evidence of absence, and everyone on the panel must realize this. Given Dr. Mulrow’s 2001 publications in support of CBT and GET, and the risk of her inability to fairly consider all the evidence, IOM should establish whether she has an entrenched bias.

Conclusion

I acknowledge that I was among the ME/CFS advocates who vigorously opposed the contract with IOM when it became public in September 2013. I remain skeptical of whether the committee’s report will lead to better diagnosis and treatment for all the people suffering from this debilitating disease.

I urge IOM to add more ME/CFS experts to the panel, such as Dr. Stewart, Dr. Medow, Dr. Lipkin, Dr. Montoya, Dr. Lange, and Dr. Jason. All of these scientists will contribute knowledge that is essential to the panel’s task. I further urge IOM to thoroughly investigate and establish whether Dr. Alegria, Dr. Ganiats, and Dr. Mulrow have biases that should disqualify them from service.

Sincerely, and on behalf of the undersigned,

Jennifer M. Spotila, J.D.
Writer, occupycfs.com

Chris Heppner, Ph.D.
Vice President ME Victoria, BC

Claudia Goodell, MS
Patient Advocate- Race to Solve CFS

Joseph D. Landson
ME/CFS Patient and U.S. Navy veteran

Denise Lopez-Majano
Speak Up About ME
Parent, caregiver, advocate

Matina Nicholson
Patient Advocate

Darlene Prestwich
Patient Advocate

Tamara C. Staples
Patient, 15 Years
Patient Advocate, 5 Years

References:

(1) Light, AR, Bateman L, Jo D, Hughen RW, VanHaitsma TA, White AT, & Light KC. Gene expression alterations at baseline and following moderate exercise in patients with Chronic Fatigue Syndrome and Fibromyalgia Syndrome. Journal of Internal Medicine, (2011) 271(1), 64–81.

(2) Jason LA, Najar N, Porter N, & Reh C. Evaluating the Centers for Disease Control’s Empirical Chronic Fatigue Syndrome Case Definition. Journal of Disability Policy Studies, (2009) 20(2), 93–100.

(3) Jason LA, Sunnquist M, Brown A, Evans M, Vernon S, Furst J, Simonis V. Examining case definition criteria for chronic fatigue syndrome and myalgic encephalomyelitis. Fatigue: Biomedicine, Health & Behavior, Epub ahead of print, accessed Dec 11, 2013: http://www.tandfonline.com/doi/abs/10.1080/21641846.2013.862993?journalCode=rftg20&#.UrEQ0Y06Kw8

(4) Molina K, Chen C, Alegria M, Li H. Prevalence of neurasthenia, comorbidity, and association with impairment among a nationally representative sample of US adults. Soc Psychiatry Psychiatr Epidemiol (2012) 47:1733-1744.

(5) Yancey J & Thomas S. Chronic Fatigue Syndrome: Diagnosis and Treatment. Am Fam Physician. 2012 Oct 15: 86(8): 741-746.

(6) http://www.aafp.org/afp/2012/1015/p741-s1.html accessed December 16, 2013.

(7) Sieber, William. Calming the Anxious Brain, accessed December 16, 2013. http://www.innersolutionsforsuccess.com/PPT/CalmingAnxiousBrain_Oct_2013.pdf.

(8) Mulrow CD, Ramirez G, Cornell JE, et al. Defining and Managing Chronic Fatigue Syndrome. Evidence Report/Technology Assessment No. 42). AHRQ Publication No. 02-E001. Rockville (MD): Agency for Healthcare Research and Quality; October 2001.

(9) Whiting P, Bagnall AM, Sowden AJ, Cornell JE, Mulrow CD, Ramirez G. Interventions for the treatment and management of chronic fatigue syndrome: a systematic review. JAMA. 2001 Sep 19;286(11):1360-8.

 

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34 Responses to My Feedback to the Institute of Medicine

  1. Ess says:

    A LOT of work has gone into this; I personally have to go with CANCEL the IOM contract. Your work, time and effort is undeniably IMPORTANT!!!

  2. Carrie says:

    Excellent letter, Jennie!

  3. Christian Godbout says:

    I really salute everything written in this letter, the vibrant plea and warning as regards past mistakes, the rigorous analysis of the present panel, and the recommendations made to improve it. But there is an (absent) elephant in the room: Dr Dan Peterson! Why is he not even mentioned?

  4. Justin Reilly says:

    ALEGRIA: Having 3 PHYSICAL SYMPTOMS (MEDICALLY UNEXPLAINED OR NOT) = SOMATIZATION

    … And that’s just the start of this insane paper:

    “Whether medically unexplained or not, three or more concurrent somatic symptoms predict psychopathology and service use in community populations (2010)”
    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2905311/#!po=45.8333

    Here are the 6 big problems I found with this paper. All five statements are absolutely ludicrous:

    (1) “Proposes the use of 3+ current General Physical Symptoms for designating a ‘case'” of somatization;

    (2) They claim their finding that “Medically Unexplained Physical Symptoms were not independently associated with psychopathology” logically leads one to their above conclusion (that 3 physical symptoms = somatization)

    (3) In this study, they count a physical symptom as being definitely “medically unexplained” if the patient said their doctor didn’t mention the cause;

    (4) They say the fact that they found a high prevalence of physical symptoms (medically explained or not) in the general population, “strongly supports the observation of many previous studies in the US and abroad that have shown that somatic symptoms represent a common expression of psychopathology…” (for the ‘previous studies’ they cite Wessely and Sharpe on CFS and the other “functional somatic syndromes” as being a single somatization disorder here; http://www.simonwessely.com/Downloads/Publications/CFS/108.pdf )

    (5) Also prominently concludes that “physical symptoms are an important component of common mental disorders” dispite admitting in a much less prominent section that physical symptoms could well cause mental disorders and other alternative explanations exist for the co-occurance of physical symptoms and mental disorders;

    (6) “Several investigators have suggested that it may be unnecessary to go through all the probes and procedures to rule out medical explanations given the stepwise association between somatic symptoms and common mental disorders such as anxiety and depression in primary care.” In context, this statement seems to be saying that in studies of somatization, one should just assume that all physical symptoms in the general population are caused by mental disorders.

    The following is all that you said about this paper in your post here:
    “As we mentioned in our profile of Dr. Alegria, she has co-authored three publications potentially relevant to her views on ME/CFS. The first two (here and here) address the relationship between somatic symptoms and psychiatric disorders like depression. Only 14 symptoms were assessed in these papers, and fatigue was not one of them. The papers found that having 3 or more of the 14 symptoms was associated with depression/anxiety and mental health service use. However, one of the papers correctly noted that the data are ill suited to infer causality between the physical symptoms and mental health issues.”
    http://www.occupycfs.com/2013/12/16/iom-panelists-balance-experts-information-bias/

    Since all six of the above points made by Alegria are completely nonsensical and harmful statements about somatization, this paper alone is evidence enough, never mind her worse paper stating that CFS = the psychiatric illness Neurasthenia, that it is absolutely unacceptable to have Alegria on the IoM panel.

    • Jennie Spotila says:

      I agree that If she equates CFS with neurasthenia, then Alegria should be removed from the panel. That’s what this letter says.

      You make a strong argument based on your reading of her papers. I hope you will send your thoughts to the IOM.

  5. Justin Reilly says:

    Jennie,

    You are saying this statement she co-authored in the Neurasthenia paper leaves doubt that she equates CFS with neurasthenia?

    N.B. that she explicitly calls CFS a “neurasthenia spectrum disorder” and the cited paper calls CFS both a “neurasthenia spectrum disorder” and a “neurasthenia category.” (the cited paper’s hypothesis was that CFS would describe Idiopathic Chronic Fatigue in India)

    “Likewise, further research is needed to examine the concordance of neurasthenia spectrum disorders (e.g., ICD-10 neurasthenia, CFS, CCMD-2 and CCMD-3 [these last two are the two Chinese Criteria] for neurasthenia) across non-clinical, population-based samples across cultural contexts [cf. 21, 23].”

    http://forums.phoenixrising.me/index.php?threads/prevalence-of-neurasthenia-comorbidity-and-association-with-impairment-among-a-nationally-represen.27105/

  6. Justin Reilly says:

    I know I am just repeating myself but I am absolutely baffled at your take.

  7. Justin Reilly says:

    What Else Have We Missed?

    I am now wondering what else is out there that we have missed! We have seen that while Jennie’s group did a lot of hard work and must be thanked for that, they have also missed some obvious fatal flaws in at least one panelist. It not only is very unfair and extremely inefficient, but an impossible burden for disabled patients to uncover the biases, conflicts and incompetency of the panelists!

    Regardless of IoM policy, it is simply unacceptable for prospective panelists not to list relevant biases or mention that they have published on the topic before. The burden should certainly be on them to disclose, since they already know if these problems exist and what they are, rather than on extremely disabled patients to have to do extensive research, almost all of which is simply impossible if one does’t have free access to medical journals.

  8. Ren says:

    It’s further disheartening, though not surprising, to learn that stakeholder comments are not guarenteed to be public record. Tyranny: “cruel and unfair treatment by people with power over others”.

    How can an unethical process produce ethical results?

    • Jennie Spotila says:

      Remember that IOM is not a government agency, so they are not governed by the same rules as the agencies. For example, FDA uses regulation.gov (which makes all comments public) because they have to. IOM is not bound by that law.

  9. Ess says:

    There is a REAL problem with the IoM contract; to give ‘faith’ / ‘hope’ to something as political as this with an end-result ‘IN MIND’ is like selling ourselves down the river. The contract is set-up this way; we are in a NO-WIN situation with the IoM.

  10. Vickie says:

    Thank you.

  11. Ren says:

    Thank you for the info in post 10.

    So, our government regularly hires a non-government institute (which accepts limited public input and record) to create government policy (for said public).

    Okay, brace yourselves – it’s still not ethical (and here’s the real punchline) or “fair.” (Ha-ha-ha! She said, life isn’t fair!) Sigh. Alright – Fall off horse. Dust off self. Climb back up…

    Well, what about skywriting?? “NO IOM!” That might earn us some headlines?!

  12. Ess says:

    When we add our signatures to the New Advocates letter–we ARE speaking up directly to the IoM with CONCERNS–as Dr. Harvey Fineberg, President, Institute of Medicine is copied in the letter.

  13. Wendy Boutilier says:

    I guess the IOM is just going to steam roll over us no matter what we do. We need to think about contacting the people on the panel and telling them that ME/CFS is a biological illness and show them all the evidence, and try and get them on our side. To be honest, we are just ill patients, many bed bound and we simply don’t have the energy and resources to keep fighting the IOM and HHS. And the American newspapers and Canadian newspapers will not publish news stories on this. For god’s sake only 2 people attended the protest in Washington DC last week.

    • Jennie Spotila says:

      Contacting the members of the panel is not a good idea. It’s already started, and the panelists have been asked not to discuss anything about the study with the public until after the first committee meeting. I am confident that the ME/CFS experts on the panel will make sure that the committee considers all the evidence proving ME/CFS is a physiological illness, not a psychological one. Multiple people sending emails and papers to the panelists individually will NOT get them on our side.

  14. Jane L. says:

    Thank you to Jennie and the signatories to this letter for all the hard work that put into this. It’s an excellent letter, one that I would think will be hard not to take notice due to the obvious due diligence that went into it.

    I agree with comments above that it is ridiculous that there is no one other than disabled patients themselves to gather intel on the panel members and inform them about who they have picked. So grateful to you and your group for doing this.

    THe letter emphasizes what I think is a most critical concern for most of us from our respective experiences (or total lack thereof) with the medical establishment: spelling out just how irretrievably damaging it would be for the future of millions of current and future patients to end up with a case definition that even hints at any iota of a psychogenic etiology. In that regard, I agree with the comments above re: the huge red flag for Dr. Alegria. If I can get my act together, I intend to send them a succinct letter strongly objecting to Drs. Alegria and Ganiats (in the context of strong wariness about the IoM contract itself).

  15. Justin Reilly says:

    This post is a more in-depth discussion of Alegria’s very troubling Somatization paper, for anyone who is curious.

    Alegria proposes, any normal person with three physical symptoms, even if they are ‘medically explained’ is given a psychiatric diagnosis! (at least if you take what she says at face value and that is a reasonable interpretation because she doesn’t qualify or add anything on to that statement; And also bc the rest of this paper is such a train wreck of outlandish illogic, that interpretation of that statement would be right at home among the other extremes of ridiculousness in this paper).

    But this is just so extreme that it’s also possible, though unstated, that she thinks there should be additional criteria needed for a somatization diagnosis- I am guessing something like worrying about one’s health, since she refers to Dimsdale and the DSM 5 revision process.

    She says we should get away from qualitative criteria to dimensional criteria; what she means is that we should just count the number of physical symptoms and the more physical symptoms (even if medically explained!) the more likely the diagnosis of somatization.

    She thinks the definition shouldn’t be ‘qualitative’. which is nonsensical since the essence of a disease definition is qualitative; a disease definition MUST DESCRIBE the disease, NOT merely COUNT up SYMPTOMS without more.
    She takes the old unsupported notion in psychiatry that the more symptoms one has, the more likely they are the product of somaticization and pumps it up on steroids.

    But then, she makes two more insane leaps of ‘logic':

    (1) she says that since she found in this study that having symptoms that she characterized as “medically UNexplained” didn’t predict psychopathology AT ALL compared to if you had symptoms that were “medically explained”, she takes this to logically imply that ANY 3 physical symptoms, even if they are medically explained mean you are somaticizing.

    (2) then she cuts the rule of thumb among psychiatrists that one should have, among other criteria, at least 5 physical symptoms to qualify for somatization down to just 3 symptoms.

    She justifies this by citing her results that show that one is likely to have FEWER psychological problems if one has 5 physical symptoms than 3 physical symptoms!

    Obviously all of her findings in this study contradict her central theory, but she just finds a jaw-dropping way to incorporate them in stunning twists of illogic.

    And then she goes even further through the looking glass with the other of the 6 head-smackers I outlined in my post which starts this thread.

    Of all the papers I have read, I can’t remember one that is as stunningly ludicrous as this one, and we all have read some funny ones, haven’t we, on this ME medical investigation journey?! : )

  16. Justin Reilly says:

    The following is why I think Alegria is in league with the Wessely School to revive Neurasthenia.

    Just from Alegria’s two papers which I have discussed in the comments to this post and Jennie’s earlier post “IoM Panelists: Balance = Experts + Info – Bias
    ( http://www.occupycfs.com/2013/12/16/iom-panelists-balance-experts-information-bias/ )
    and skimming thru some of her other papers, not only does Alegria have serious biases, but she thinks illogically and her work is sloppy, which are all not great qualities for someone redefining your disease!

    The somatization paper (see my other thread), is just absolutely insane, piling gross illogic upon itself into one big stinking turd. This paper is more subtle, if you could call it that, but still very odd.

    Just the idea of making such a big study of neurasthenia and saying we must study it further as though it were useful to dredge up an antiquated diagnosis, some of whose problems were, as Angela points out, visible and troubling even at the turn of the last century, is bizarre

    I understand that the diagnosis survived much longer in China than it has here, but from what I have read, the diagnosis has been fading out even in the East for decades with the long effort that has and is being made to reconcile and standardize Western medical diagnoses throughout the world.

    The papers that do talk about it as a diagnosis in the East all seem to conclude, though I just skimmed through a number of papers, that neurasthenia was an unscientific relic that just lingered because it provided a semi-medical seeming diagnosis for doctors to use who didn’t want to burden their patients with the stigma of mental illness, which is really what they had (at least according to these papers)

    So, there is no really useful medical/psychological reason to study neurasthenia in the general population in the US. And Alegria doesn’t give one, which is really weird. You’d think someone writing about such an irrelevant topic would provide a reason in the paper.

    So, that just leads me to believe that she is in league with the Wessely school to revive neurasthenia for the sole reason of making ME seem to be psychiatric. Is there any other plausible reason?

  17. Justin Reilly says:

    Sorry to clog your comments section, Jennie, maybe I need my own blog!

    The following is a summation of why we must oppose Alegria and Mulrow and the contract in general:

    First, Alegria fails to mention that she has spoken and written on neurasthenia in several papers. Then that she says CFS is a ‘neurasthenia spectrum disorder’, which, according to her is somatization disorder. Then she turns out this absolutely insane paper on what she thinks somatization is!

    These two papers prove that, not only does she think CFS is psychiatric, but that she also has incredible difficulty thinking logically (which is a detriment being a scientist on our disease definition panel) especially about our disease and related issues.

    Alegria absolutely must not be allowed anywhere near our definition!

    And neither can Mulrow, who writes that CBT and GET are the only effective therapies for ME; and that conclusion regarding GET is based ENTIRELY on OXFORD definition studies! In her paper, she rated OXFORD definition studies HIGHER than FUKUDA studies!!

    And she didn’t disclose she had ever worked on CFS before, much less headed the official AHRQ (part of HHS) committee on CFS treatments or that she used to work for the VA.

    These are the type of highly incompetent, illogical, and specifically biased people IoM are trying to sneak by us to ruin our definition and thus our health and lives for years!

    We can’t have any tolerance for this bad faith destruction of our health! This contract MUST be cancelled- there’s more proof of that then ever!

    • Jennie Spotila says:

      As I said before, Justin, I really think you should write to IOM and express your opinions about Alegria and Mulrow.

  18. Ren says:

    Ess, I hope so. I’ve fought a good deal of my (personal) fight outside the U.S., and my expectations are very much shaded by these experiences. And I worry (like others) that the U.S. is on a similar trajectory.

  19. Wendy Boutilier says:

    Have any other ME and CFS advocates written into the IOM ? What about Cort Johnson, Michael Evison, Tom Kindlon, Toby Vokal, Kim McCleary, Joan McParland, Mary Schweitzer, etc. ?

  20. Ess says:

    @Ren
    Your worry–and OUR collective ALARM and DISTRUST at the current situation with the IoM contract is WELL warranted; MORE THAN WARRANTED, Ren. The fight IS on–has been for decades–and recently has necessarily ESCALATED in seeking JUSTICE for ME/CFS patients.

    The FACT that the ME/CFS EXPERTS AND RESEARCHERS are STANDING UP for the ME/CFS COMMUNITY in OPPOSITION to the IoM contract speaks VOLUMES, and ALIGNS with our worry, our ALARM about the current situation in the U.S. with the IoM contract–and its INTENDED results (with potential world-wide ramifications).

    How can we ever thank these ME/CFS EXPERTS AND RESEARCHERS enough for taking this STRONG STANCE on our behalf . . . Let’s BACK THEM UP!!!

  21. Ess says:

    @Justin Reilly Thanks for digging DEEP re Alegria et al; hear ya / read ya loud and clear . . . !!!!!

  22. David Egan says:

    Dear Sir / Madam,
    I am a US citizen and I suffer from ME/CFS since 2002. I would like to raise the following objections to these three people being on the IOM panel on the grounds of bias against ME/CFS and conflicts of interest.

    1. Dr. Margarita Alegria
    2. Dr. Theodore Ganiats
    3. Dr. Cynthia Mulrow

    I will detail my objections and the objections of many ME/CFS patients in the USA and outside it below.

    Dr. Margarita Alegria

    In her paper
    ‘Prevalence of neurasthenia, comorbidity, and association with impairment among a nationally representative sample of US adults’ . Social Psychiatry and Psychiatric Epidemiology November 2012, Volume 47, Issue 11, pp 1733-1744

    Alegria falsely claims CFS is a ‘neurasthenia spectrum disorder’, which, according to her is somatization disorder.

    “Likewise, as Lee [51] argued, the ‘‘disappearance’’ of culture-bound syndromes is related to changing sociocultural conditions, including economic and political factors and changes in managed care and pharmaceutical forces, to name a few. Indeed, chronic fatigue syndrome (CFS), also a controversial illness which has been argued to be a variant of neurasthenia [4, 21] has become increasingly diagnosed in the US [52, 53], whereas neurasthenia is virtually no longer diagnosed in the US context [51].”

    “may present with symptoms of neurasthenia, but may otherwise be misdiagnosed as having depression, anxiety, or CFS.”

    Samples were acquired from two national household surveys and not from patients or blood samples and other samples or scans. Its lack of scientific precision is obvious from the start. In the latter paragraph above she claims depression, anxiety, or CFS are a misdiagnosis and that neurasthenia is the proper diagnosis. Thus she equates neurasthenia with CFS, which is utterly ridiculous and goes against the vast scientific research and clinical findings. The term ‘neurashtenia’ which she uses quite a lot in papers, has never been defined with precision and biomarkers, and it is a clinical non entity ; it is well established as a means to not bother diagnosing a patient properly and not carry out appropriate laboratory and medical tests. And to neglect the patient. Neurasthenia is a term which was replaced regularly by doctors who took the time and effort to properly investigate, diagnose and test an illness.

    This was the case when the name ‘Neuroasthenia’ was replaced during epidemics and clusters, notable replacements being ‘Epidemic Neuromyasthenia’, ‘Encephalitis’, ‘Akureyri Disease’, ‘atypical poliomyelitis’, ‘poliomyelitis-like epidemic neuromyasthenia’ ‘Abortive Poliomyelitis’, ‘Myalgic Encephalomyelitis’ from the 1930’s to the 1990’s. These names describe a biological illness with underlying infections and biological dysfunctions and abnormalities. ‘Neurasthenia’ was falsely applied to these illnesses in the past, and encouraged by some medical authorities, but it’s ineffectiveness and failure as a term, a name, a definition, a description was and still is clear for all to see. Where the term ‘Neurasthenia’ was replaced during these epidemics, patients had a better chance of getting proper medical treatment. One should not describe physical, biological illnesses as psychiatric or psychological, but this basic rule of science and medicine has not fully been heeded in some quarters, even today . It is very clear that the use of the term ‘Neurasthenia’ is a means to dismiss patients, neglect patients, and give them a false and meaningless psychiatric diagnosis which totally ignores the underlying pathology, disease processes and biological dysfunctions.

    I would strongly advise Dr. Alegria to re-read the history of these illnesses as she seems completely confused about them, and her paper conveys this confusion, and unfortunately adds to it.

    ‘Epidemic Neuromyasthenia’, ‘Encephalitis’, ‘Akureyri Disease’, ‘atypical poliomyelitis’, ‘poliomyelitis-like epidemic neuromyasthenia’ ‘Abortive Poliomyelitis’, ‘Myalgic Encephalomyelitis’ are all associated with ME and CFS and the term now used by IOM – ‘ME/CFS’. Her use of the outdated and meaningless term ‘Neurasthenia’ which was illegally used in the past to label and describe these illnesses, shows that she has a misunderstanding of the illness and a bias against the illness.

    She believes ‘Neurasthenia’ to be a somatic disorder and by linking ME/CFS to ‘Neurasthenia’ she also believes ME/CFS to be the same. Her views on somatic syndromes are that they are psychiatric conditions consisting of just 3 physical symptoms, not the 14 recommended by most psychiatrists. This is outlined in her other paper

    Whether medically unexplained or not, three or more concurrent somatic symptoms predict psychopathology and service use in community populations. Javier I Escobar. Benjamin Cook, Chi-Nan Chen, Michael A Gara, Margarita Alegría, Alejandro Interian, and Esperanza Diaz. J Psychosom Res. 2010 Jul;69(1):1-8.

    She further emphasises in her paper below that 3 or more physical symptoms
    “can be used to designate a “case” and that detailed probes and procedures aimed at determining whether or not physical symptoms are medically unexplained may not be necessary for classification purposes.”

    She goes on to state that a high prevalence of physical symptoms (medically explained or not) in the general population, “strongly supports the observation of many previous studies in the US and abroad that have shown that somatic symptoms represent a common expression of psychopathology…” She supports this by quoting Wessely and Sharpe and their views of CFS and ME – [11] Wessely SC, Nimnuan C, Sharpe M. Functional somatic syndromes: one or many? Lancet. 1999;354:936–9.
    Paper here at http://www.simonwessely.com/Downloads/Publications/CFS/108.pdf . She is firmly in the wessely school of psychiatrists.

    She goes on further to state “physical symptoms are an important component of common mental disorders”

    Thus she is totally against standard medical and laboratory tests for those patients with 3 or more symptoms. This is extraordinary, as a person could have Cancer, AIDS, or severe illness and she would be only interested in converting it into a somatic disorder to be diagnosed and treated psychiatrically. Many, many illnesses require intensive tests and follow up tests to confirm a physical illness, yet she would deny all this in the interests of promoting somatic syndromes. She and her researchers naievely assume that all physical symptoms in the general population are caused by mental disorders. This is a new departure in medicine, away from old fashioned ideals of precision, honesty and respect and Hippocratic oaths.

    She fails to differentiate between what she claims are “somatic symptoms” and real physical symptoms, and she fails to elucidate the causative factors behind the physical symptoms or encourage such elucidation. She and other researchers were unable to differentiate between what is physical and biological on the one hand and what is psychiatric on the other hand. But by covering both up with the concept of ‘somatic syndrome’ or ‘somatisation’, she can claim both are somatic, and thus label many illnesses with the somatic tag. This is unscientific and anti-medical, one would have to wonder are the researchers themselves trapped in some somatic disorder ?

    Her paper above shows a complete ignorance of environment in the development of illness. Like some other somatic researchers she fails to understand the effects of environment and environmental factors both on one’s genes, one’s exposures, one’s development, and one’s susceptibility to illness. If she and other researchers took the time and effort to research the effects of concentrations of wealth and income and the wider social effects of this on health and well being and healthcare spending and willingness to spend, she would come to some very different conclusions, one’s which could not be solved by dosing people with psychiatric drugs and use of GET and CBT. Many eminent institutions and bodies have published on the effects of extreme wealth and income inequality and poor health outcomes for the working class and the poor.

    She is a psychiatrist who has a vested interest in pursuing a psychiatric explanation of ME and CFS and promoting the somatic syndromes agenda across the world, which have obvious financial and other rewards for some, and thus she has a conflict of interest. She has shown bias in relation to her remarks about CFS and Neurasthenia in the past. She should not be on the IOM panel.

    Dr. Theodore Ganiats

    He is affliated with the American Academy of Family Practitioners which published misleading and wrong information about ME/CFS in 2012, claiming it was mainly psychological. It recommends psychiatric treatments which have been found to be ineffective and dangerous to many patients. Their views go against the scientific research and clinical findings into ME and CFS. He has co-authored and is a close friend of Dr. William J. Sieber who falsely claims ME and CFS are psychological. He may be subject to the prejudices, influences and biases of close colleagues and a possible conflict of interest may arise. He should not be on the IOM panel

    Dr. Cynthia Mulrow

    She was involved in a study and a published paper in 2001 which had several flaws and defects.
    Interventions for the treatment and management of chronic fatigue syndrome: a systematic review. Whiting P, Bagnall AM, Sowden AJ, Cornell JE, Mulrow CD, Ramírez G. JAMA. 2001 Sep 19;286(11):1360-8.

    Firstly, the patients in the studies reviewed were not given the required immune system tests, full blood, spinal fluid and nerve, muscle and intestinal tissue tests for infectious diseases, HPA axis and endocrine tests, neurological tests, exercise tests, cardiology tests, and mitochondria tests. Thus the individual studies and the researchers reviewing them did not establish who had CFS or ME or some other illnesses and what the biological abnormalities and dysfunction were. The so called “treatments” in the study were not selectively targeting anything as the diagnosis and biological abnormalities had not been done/ identified. The paper is below

    The following findings from the study confirm the defects mentioned above

    “CFS was taken to mean all illnesses, including ME and PVFS with symptom complexes similar to CFS, unless otherwise stated.” (p. 1360) The analysis found that there was no significant association between the definition used and treatment study outcome (p. 1366). However, the paper also reports many weaknesses and limitations in the treatment studies, including the failure to characterize baseline functionality in a standardized way. CBT and GET were considered promising “

    “DATA SYNTHESIS: The number of participants included in each trial ranged from 12 to 326, with a total of 2801 participants included in the 44 trials combined. Across the studies, 38 different outcomes were evaluated using about 130 different scales or types of measurement. Studies were grouped into 6 different categories. In the behavioral category, graded exercise therapy and cognitive behavioral therapy showed positive results and also scored highly on the validity assessment. In the immunological category, both immunoglobulin and hydrocortisone showed some limited effects but, overall, the evidence was inconclusive. There was insufficient evidence about effectiveness in the other 4 categories (pharmacological, supplements, complementary/alternative, and other interventions).”

    The results were highly predictable given the poor quality of the individual studies themselves and the poor quality of the review. The main influence in all of this was psychiatry in the sense that it trivialised the illness, actively blocked research into ME and CFS throughout the 1990’s and early 2000’s and created the popular perception of “yuppie flu”. This undermined the identification of and analysis of biological markers for the illness in research trials, markers identified through immune system tests, full blood, spinal fluid and nerve, muscle and intestinal tissue tests for infectious diseases, HPA axis and endocrine tests, neurological tests, exercise tests, cardiology tests, and mitochondria tests.

    The fact that Dr. Mulrow supported CBT and GET findings in this study strongly suggests some bias on her behalf. She has not disputed or contradicted or questioned these findings since 2001. She should not be on the IOM panel.

    Replacements
    The IOM should consider replacing these 3 people with some medical doctors and researchers with relevant experience, such as

    • Dr. Dan Peterson a medical doctor with over 25 years experience treating CFS and ME and researching the illness.
    • Dr. Kenny De Meirleir a medical doctor with over 20 years experience treating CFS and ME. and researching the illness
    • Dr. Leonard Jason, a Epidemiologist and Statistician who has studied this illness and other illnesses for over 10 years.
    • Dr. Paul Cheney a medical doctor with over 25 years experience treating CFS and ME and researching the illness.
    • Dr. Edward Conley a medical doctor with over 18 years experience treating ME and CFS
    • Dr. Byron Hyde a medical doctor with over 20 years experience treating CFS and ME and researching the illness.

    These measures would help build some confidence in the IOM panel among the ME/CFS community and assist the IOM in its objectives.

    Best Regards
    David Egan

  23. Ess says:

    @David Egan STELLAR articulation on all points in your letter, David! THANK you!!

    Helps to give CLARITY to the methods and the ‘entrenched madness’ of a ‘select faction’ . . . and the history of how ERRONEOUS ‘psychobabble’ evolved because NOT much attention was being paid.

    BUT times are DIFFERENT NOW; MUCH ATTENTION IS being paid, and there is UNdeniable AWARENESS by the EXPERTS AND RESEARCHERS that ME/CFS is AFFIRMATIVELY A BIOLOGICAL DISEASE–indeed, a DEBILITATING DISEASE that is spreading–both at home in North America and world-wide. AND that RESOUNDING FACT concerns the EXPERTS AND RESEARCHERS GREATLY!

    “The results were highly predictable given the poor quality of the individual studies themselves and the poor quality of the review. The main influence in all of this was psychiatry in the sense that it trivialised the illness, actively blocked research into ME and CFS throughout the 1990’s and early 2000’s and created the popular perception of “yuppie flu”. This undermined the identification of and analysis of biological markers for the illness in research trials, markers identified through immune system tests, full blood, spinal fluid and nerve, muscle and intestinal tissue tests for infectious diseases, HPA axis and endocrine tests, neurological tests, exercise tests, cardiology tests, and mitochondria tests.”

    The last sentence describes exactly what the EXPERTS AND RESEARCHERS are hard at work with NOW–identification and analysis of biological markers.

    Yet, as we KNOW the HHS has NOT invited MEANINGFUL dialogue with the experts and researchers in response to the EXPERTS’ letter . . . leaves MANY MANY questions and VALID concerns as to WHY NOT.

    AND, therefore, that brings us to where we are at articulating and voicing our EXTREME CONCERNS RIGHT ALONGSIDE OF THE ME/CFS EXPERTS AND RESEARCHERS!!

  24. Justin Reilly says:

    Wendy Boutilier :
    I guess the IOM is just going to steam roll over us no matter what we do. We need to think about contacting the people on the panel and telling them that ME/CFS is a biological illness and show them all the evidence, and try and get them on our side. To be honest, we are just ill patients, many bed bound and we simply don’t have the energy and resources to keep fighting the IOM and HHS. And the American newspapers and Canadian newspapers will not publish news stories on this. For god’s sake only 2 people attended the protest in Washington DC last week.

    I think contacting the potential panelists with helpful info is a good idea. I support sending Osler’s Web, the various excellent ME guidelines, etc. The prejudice against the real ME science is so profound including among doctors that a head start in informing them is needed.

  25. Justin Reilly says:

    @David Egan,
    Great letter! Thank you for writing this! I agree practically 100%.

    (I want to quibble with a tiny part of your paper in the spirit of constructive criticism to up our game even higher than its current heights.

    (a) you say Neurasthenia has been used ‘illegally’ in the past. I don’t know of that being the case, though I don’t know much about the diagnosis. Can you expand on that?

    (b) like most people in my experience, you use the term “somatic” to mean “psychogenic” (originating in the “psyche”). Somatic actually means ‘bodily’ or physical from the ancient greek word for body ‘soma.’ I request that you use the term “psychogenic” instead as it is, strictly speaking, more correct. quibbling done : ) )

  26. Justin Reilly says:

    I have posted a PDF of my letter to IoM on Phoenixrising.me:
    http://forums.phoenixrising.me/index.php?threads/occupy-cfs-my-feedback-to-iom.27152/#post-414662

    Here is Gabby Klein’s letter:
    http://forums.phoenixrising.me/index.php?threads/occupy-cfs-my-feedback-to-iom.27152/#post-414383

    I suggest that anyone who has not yet written in simply endorse a letter or letters that they like, such as mine, Gabby’s or David Egan’s, above, if there is one you agree with. You can also of course say you endorse a letter with deletions (made clear by blacklining) or additions if you wish. This will save some precious energy.

    Of course, if you don’t agree with our letters, pls send in your own if you think ‘engagement’ is appropriate.

    Anyone else who writes a letter, again, please post it here and on Phoenix Rising so others can get ideas or simply endorse your letter to the IoM.

    Send to: mecfs@iom.edu

  27. Eliza says:

    Jennie, thank you for offering this model response and for all the work you and the advocate team have done to prepare the community to deal with the IOM panel and process. I appreciate the integrity you consistently demonstrate in the writing of your blog posts and in administering your comment policy–such as tolerating comments that encourage the readers of your blog to endorse other people’s letters but not your own in this very post.

  28. Ess says:

    The work of Jennie and her team is MOST appreciated; and, indeed, collectively across cyber-space we are all striving towards the same end goal–to get our lives back from this horrid life-altering, life-stealing disease that we SUFFER with day-to-day; year-after-year; decade after decade–and to STOP ME/CFS from spreading further.

    May the NEW YEAR 2014 bring about a HUGE change for meaningful discovery and treatment for p/w ME/CFS; may there be ‘life’ for us!!

  29. CFS Sufferer says:

    I just want to say thank you so much for your efforts…I’m so tired of being sick and having no hope and just overall being disgusted with what appears to be constant steering to manipulate an outcome just for the sake of trying to make it ‘all go away’…Thank you…

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