P2P Agenda: What the Huh?

Less than six weeks from the NIH P2P Workshop on ME/CFS, and we now have an agenda with speakers and talk titles.  So is it good or bad?

I reached out to the six ME/CFS members of the Working Groups for their thoughts on the agenda. Dr. Suzanne Vernon told me, “[T]he agenda uses a comparative effectiveness approach and format to address the key questions initially posed by the working group.  I think they’ve invited a relativity good mix of speakers with a range of expertise and experience to help inform the panel.” Three members did not respond and one responded but did not comment. The sixth member of the Working Group would only comment off the record, and said that some of the line up was solid but some of it was disappointing.

I agree that there are some bona fide experts on the agenda, speakers like Dr. Jason, Dr. Nacul, Dr. Klimas, and Dr. Snell. They are obvious choices for their expertise. But then there are some speakers that made me stop and think “What the what? Are you kidding me?”

The Problematic Cluster

The second main topic of the Workshop is titled: “Given the unique challenges of ME/CFS, how can we foster innovative research to enhance the development of treatments for patients?” This is a critical question, and brings to mind things like centralized data repositories, the case definition issue, drug repurposing, or systems networking and bioinformatics work like that of Dr. Gordon Broderick or Dr. Patrick McGowan.

Instead, this section focuses on studying diseases other than ME/CFS as a way to back into ME/CFS results. I’m fully in favor of out of the box thinking and learning from other scientific areas. Autoimmune and autoinflammatory diseases come to mind as one promising area. But that’s not what we’ll hear at the P2P Workshop.

The Speakers

The three speakers for this section are Dr. Dedra Buchwald, Dr. Dan Clauw, and Dr. Niloofar Afari. If anyone thought that psychosocial theories and functional somatic syndromes would not make an appearance at the Workshop, I’m afraid I must correct your false workshop belief.

Dr. Dedra Buchwald has been a CFS researcher for years, heading one of the ill-fated NIH CFS Research Centers more than a decade ago. She has built a large twin registry at the University of Washington, and has developed broad expertise in Native American health issues and studies. But her work on chronic fatigue syndrome is controversial.

Many of Dr. Buchwald’s publications focus on the predisposing role of trauma in CFS, the high rates of depression and anxiety in CFS, and an integrative view that blends it with FM and a broad view of the illness.

As just one example, Dr. Buchwald co-authored a topic summary on CFS with Dr. Craig Sawchuk (who did his postdoc work with Dr. Buchwald and was co-director of the Harborview Chronic Fatigue Clinic). This summary includes many elements from the integrative or psychosocial model of CFS. Under risk factors, the guide states, “Premorbid psychiatric illness can increase risk for CFS, including personality traits such as ‘action-proneness’ and emotional instability,” and “Historical patterns of persistent over- and underactivity levels may confer risk for CFS in adulthood.” For treatment, pharmacotherapies are not recommended, except for comorbid disorders. “CBT and graduated exercise therapy have the greatest cost effectiveness and probability of yielding symptom and functional improvements.” Exercise begins with 5-minute periods of aerobic exercise five times a week. CBT is “designed to modify thoughts, behaviors, and environmental contingencies that are maintaining or exacerbating symptoms and impairments.” Finally, “Treatment-resistant patients should be referred to a mental health professional.

These kinds of recommendations are familiar to every patient with ME/CFS. It is a view of the disease based on disordered patient perception and secondary deconditioning. This view persists in the face of thousands of papers to the contrary. All the contrary data – and there is a lot of it – is ignored.

Dr. Dan Clauw is Director of the Chronic Pain and Fatigue Research Center at the University of Michigan. His focus has been fibromylagia and the “chronic multisymptom illnesses,” such as CFS and GWI, that accompany it.  Dr. Clauw treats FM with a balanced approach using both medication and exercise/CBT. He has extensive connections to pharmaceutical companies, including funding from Eli Lily to create FibroGuide, a CBT program for people with FM.

Dr. Clauw spoke at the P2P Workshop on Opioids and Chronic Pain at the end of September, and some of his comments were surprising, to say the least. Using the term “fibromyalgianess,” Dr. Clauw favors using a self-report questionnaire rather than “a stupid tender point count.” Acknowledging that he was being provocative, Dr. Clauw said, “I view opioids as the Kardashians in the chronic pain field. And the reason I say that is that I think they receive an undue amount of attention. We should really have just stopped the meeting after we went through all those slides showing that they’re not efficacious in chronic pain.” Then there was this gem:

I also think we can probably prevent the transition from chronic nociceptive pain to chronic centralized pain. I think that that’s something that we likely…. I can with a reasonable degree of accuracy, I can look at someone’s medical record at age 20 and tell you if they’re going to develop fibromyalgia at age 40. They would already have 2 or 3 regional pain syndromes by their early 20s and they’re marching down this course and we don’t do anything right now to try to do primary or secondary prevention and I think  most of us feel that fibromyalgia’s just sort of the end of a continuum.

I appreciate that Dr. Clauw is saying that early and adequate treatment of pain can prevent that pain from becoming chronic and refractory to treatment. But claiming he can look at the chart of a 20 year old and predict whether they will have FM? Really? Do you know what my chart looked like up until age 26? Perfectly clean, healthy, with a few short acute infections that fully resolved, and absolutely no other medical or psychological problems of any kind. Then I got sick with an apparent viral infection and here I am 20 years later, in my 40s, with ME/CFS and FM and POTS. The claim that this could be predicted from my chart at age 20 is ridiculous.

Dr. Niloofar Afari is a psychologist who was Associate Director of Dr. Buchwald’s center from 1998 to 2006, and is now at UC San Diego. Much of her work has focused on twin registry projects and treating a number of pain conditions. One of her more recent papers is an examination of the association between psychological trauma and functional somatic syndromes like CFS and FM. The study found that people with trauma were 2.7 times more likely to have a functional somatic syndrome, and CFS was included in that category.

Drs. Buchwald, Clauw and Afari overlap each other to a great degree. They have co-authored papers together, they’ve worked together. Their views on ME/CFS are at the opposite end of the spectrum from researchers like Dr. Klimas, Dr. Jason or Dr. Montoya. Having an opposite view does not automatically disqualify them from speaking at the Workshop, in my opinion. But their presence on the agenda, especially in the context of fostering innovative research, is a huge red flag.

We already have a systematic evidence review that combined eight ME and CFS case definitions, despite stated misgivings that it could include people without the disease. Layered on that, we have this attempt to create innovative research by looking at overlapping and co-morbid conditions – but only functional somatic syndromes. The Workshop is not going to look at the co-morbidities of orthostatic intolerance, Lyme disease, reactivated viral infections, cancers, or Ehlers-Danlos syndrome. Nor is it going to draw clean lines around ME/CFS for research purposes. If anything, this paves the way for broader cohorts. ME/CFS research and the care of ME/CFS patients will not be advanced through this dangerous sinkhole of examining trauma or lumping our already overly broad category into the shapeless mass of “fibromyalgianess.” Studying so-called functional somatic syndromes is not innovative research; this approach is outdated, and brings confusion instead of clarity to ME/CFS research.

The Overlap

There’s another layer of weird overlap, in addition to the research/publishing overlap of Buchwald, Clauw and Afari.

In 2012, NIH hosted a Workshop on Overlapping Chronic Pain Conditions. The meeting was co-chaired by Dr. Clauw and Dr. Beth Unger. Among the talks were:

  • Overview of the meeting and chronic overlapping pain conditions by Dr. Clauw
  • Understanding chronic overlapping pain conditions: Lessons learned from twin studies by Dr. Afari
  • What has the CDC’s ME/CFS program taught us about overlapping conditions? by Dr. Unger
  • Overlapping pain conditions: Disparities and special populations by Dr. Carmen Green (University of Michigan)

That last talk is important, because Dr. Carmen Green is the chairman of our P2P Panel. Dr. Green is on the faculty of the University of Michigan, as is Dr. Clauw. She is also a member of the Interagency Pain Research Coordinating Committee (IPRCC). Dr. Green and Dr. Unger serve together on the subcommittee on Public Health Disparities for the IPRCC.

Does this seem weird? One section of the P2P Workshop is being given to Buchwald, Clauw and Afari, who have published together and share a particular disease view of ME/CFS. Then we throw in this 2012 meeting, which Dr. Unger co-chaired with Dr. Clauw, and where she spoke about what CDC’s program on ME/CFS can teach us about overlapping conditions. Also presenting at that meeting was Dr. Green, who not only serves on the IPRCC, but also serves on a subcommittee of IPRCC with Dr. Unger.

ME/CFS is a small field, and there is going to be overlap among researchers, meetings, and programs. That overlap does not in and of itself disqualify anyone from participating in other activities like this Workshop. But recall that the P2P Panel is selected by NIH to be ME/CFS bias-free. The idea is to form an impartial “jury” that has not researched or treated people with ME/CFS. We already have a high obstacle given that 85% of doctors believe CFS is wholly or partially psychological, so finding a blank slate group of experts was always going to be a challenge.

We can’t know for sure what Dr. Green’s views are, especially as the Panel selection process has been completely hidden from the public. She may or may not share views with Unger, Clauw, Afari or Buchwald. Maybe she thinks they’re wrong, or maybe she is keeping an open mind and will listen to all the speakers. But the overlaps here are a cause for concern.

Now someone could very well say, Hey, you’re not complaining about the overlap between Klimas and Natelson on the IOM committee and this meeting. Or the connections between Dr. Jason, Dr. Taylor and Ms. Brown. But Dr. Green is the P2P Panel Chair, and so her connections with some speakers who view CFS as part of a broader morass of fatigue and pain conditions is a legitimate concern.

Old Guard

This looks like old guard NIH. That “innovative research” section represents the same disease view that filled the CFS Special Emphasis Panel with experts on TMJ and FM. It is the disease view that refuses to acknowledge the muddle of case definitions, including the disproportionate selection of people with primary depression. This is the disease view that, as stated on the draft agenda I received through FOIA, has Dr. Susan Maier speaking about “overwhelming fatigue or malaise as a public health problem.”

The first part of the equation is the fundamentally flawed evidence review that ignored all of the most promising biomarker and treatment research. Add that to this Workshop which has an entire section based on the innovative old view of CFS as a condition perpetuated by deconditioning and emotional problems. What can we expect the sum of those two factors to be? Speakers like Klimas, Snell, Jason and others have an uphill climb to present all the evidence that contradicts this old guard view, and succeed in convincing the unknown Panelists that it is time for NIH to move forward.

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49 Responses to P2P Agenda: What the Huh?

  1. Wendy B. Gessler says:

    My CFS/ME was rather sudden in it’s onset, with typical flu-like symptoms that never quite improved. I was bedridden for months. Of course, I had to lose everything, including my home of 17 years before the SSA would acknowledge my diagnosis & inability to work. My private short-term disability & long term disability disagreed with my doctor, arguing I could do sedentary work, which was what my job had been. Ruled out all possible others, esp. Scleroderma, as mother had that. Also had change in baseline temp to constant 97.2F. Had partner w/CFS for 6 years. Infectious, genetic predisposition? Klimas the only doctor making any sense. No pain in 20’s, even 30’s. Do have TMJ & double jointed. Listen to the patients! Do extensive medical & familial hx.

  2. Mary Dimmock says:

    Thank you, Jennie. Excellent post.

    In the movie, Ground Hog Day, an arrogant, self-centered weatherman played by Bill Murray is doomed to repeat the same day over and over again until he finally learns that his actions and behaviors are what are keeping him stuck in a time loop. To escape, he must change. HHS’ actions toward this disease are stuck in a time loop that is a product of its arrogance, its isolation, its cognitive bias and its utter refusal to listen to what patients and experts have been telling them for thirty years.

    The cognitive dissonance apparent in the selection of these speakers for a discussion on fostering innovative research to enhance the development of treatment is especially stunning in light of the press coverage this week for Stanford’s study on brain abnormalities. Parallel universes.

    In the case of Ground Hog Day, it’s Bill Murray who suffers the consequences that have resulted from his arrogance and egocentism. Tragically, in the case of ME, it is the patients that have paid the ultimate price with decades of debility and destroyed lives. That is unconscionable.

  3. cort says:

    I like Jason, Dr. Klimas and particularly Dr. Snell given his exercise studies…

    Dr. Buchwald does fit the “ME/CFS expert” title – she’s published a lot of studies – but I agree that she’s a horrible choice. Aside from the twin studies – which unfortunately didn’t really show much – I don’t think she’s done anything innovative in this field and her approach has become more and more psychological over time. She doesn’t seem to interact with any of the researchers we’re familiar with. I can’t remember seeing her at one of the IACFS/ME conferences for instance. She ran the Seattle CFS research center before it was closed down in the early 2,000’s.

    I don’t know why they would put an FM researcher on there, particularly one with such a controversial view on defining FM. Clauw is well respected and he’s done a lot of work but I don’t see why he’s on there….That seems weird to me.

    Afari has done a lot of work on ME/CFS but she represents a similar part of the ME/CFS research field as Buchwald. – very psychologically oriented with little or no interest at the pathophysiology in this field.

    Buchwald and Afari are very conservative choices – both are definitely in the NIH pipeline.

    I agree – aside from the presence of Klimas, Jason and Snell – a strange and rather unsettling lineup…

  4. pat fero says:

    If we expect grant money to go toward replication of the best new studies on brain imaging, cognition and blood flow with PEM tossed into the mix, then the 3 pain, fatigue and sleep experts will have to expand the use of their NIH money to include new case criteria ME identified patients. Looking at past grant histories, abstracts and publications confirms what Jennie so eloquently states in WHAT THE HUH?

    Nothing to see here folks. We’ll just hammer that square peg into a round hole until it is chipped away to fit the hole. TA DA. See? it works.

    I SO HOPE this is not the case.

    Drs Clauw and Buchwald were CFS investigators who moved to FM and umbrella pain, sleep and fatigue patients which is not to say they are poor scientists or that they see people who are any less ill than ME patients. BUT, it is the wrong population.

    Justify the NIH money trail! It makes me sick and sad. IT IS PERSONAL. It is personal for all of us. I just read an autopsy report for a grieving spouse. The woman had little pain. She died of heart disease which showed on autopsy to be mild. I wonder why every body organ to include brain was congested, fluid filled. THUNK. 2o year CFS patient. No answers, just grief and loneliness.

    Pardon me, it is not to be taken personally. It’s business.

  5. Rivka says:

    Thanks, Jenni, for this important information and analysis.

    Well, I guess the fact that my new protocol of antiviral meds is resulting in a significant decrease of my ME/CFS symptoms is due to… wait for it… a personality disorder and childhood trauma! A personality disorder that responds to Famvir? Who knew!?

    That was sarcasm, folks. But it is pretty clear that my personal benefit from antiviral meds and the result of Stanford’s study published this week (indicating a virus could be causing brain problems in patients) is moot in the eyes of key presenters at this upcoming conference.

    How sad that their utter ignorance will impact a million lives in the USA, 17 million around the globe.

    This horror show just goes on and on and on and on. Patients have been too weak to function and have spent decades in isolation and forced bed rest — for 30 freaking years now. And why? The answer is clear: government neglect, government psychologizing, government delegitimization.

  6. Chris says:

    Jennie, welcome back, though bringing unwelcome news. It really does sound appalling–“innovative research”=same old lies, same old lies–just don’t know how to respond. I guess it is too late to send a response, and it obviously does no good anyway. Though I did have multiple traumatic situations when young, I lived 70 brilliantly healthy and very active years before ME hit.

    “Historical patterns of persistent over-and underactivity levels”–one way or another, it is all our fault. We are stuck in the junkyard of psychiatry along with those “refrigerator mothers” who were responsible for autism, the masturbation that caused schizophrenia–the dark lumber-room of psychiatric history.

    I also catch a distinct and serious threat in “Treatment-resistant patients should be referred to a mental health professional.” Echoes of poor Katerina. The whole thing looks just appalling, and I have no idea how the good people will be able to make a dent in what is evidently firmly established belief.

    I am having a lousy week even apart from this–but still many thanks for keeping information coming to us. Chris

  7. jim says:

    “Historical patterns of persistent over- and underactivity levels may confer risk for CFS in adulthood.”

    Translation: “It’s the patient’s fault.”

  8. Ess says:

    All part of the game plan–cherry picked for exacting HHS’ predetermined BOGUS outcome–which equals to the ongoing LIES and cover-ups of the truth to BIO disease M.E. that have been perpetrated for 30 years.

    It is CRIMINAL to rob us all of life this way–and continue to spread the pandemic! What CORRUPTION abounds!

  9. Ess says:

    It is ALL part of the game plan–‘cherry picked’ to exact the predetermined outcome dictated by HHS.

    HHS’ NIH-IOM-P2P amounts to ONgoing and purposely furthering the LIES and cover-ups regarding the BIO disease M.E. It is a BOGUS set-up; we are being FRAMED with OUTdated DISinformation; LIES.

    These actions are CRIMINAL; just like it is CRIMINAL to rob us of life and to perpetuate the pandemic of M.E.

    This smacks of CORRUPTION to the core!

  10. Kathy D. says:

    Hi everyone,

    I think we have to push the latest study by Dr. Jose Montoya, et al., at Stanford School of Medicine, published in Radiology on Wednesday. Using high-tech MRI imagery, the researchers found 3 distinct types of brain abnormalities in people with ME/CFS.
    This is a tremendous discovery. Other studies have found brain abnormalities, including Japanese scientists, but this is at Stanford.
    The articles on this are impressive. I think we should flood this committee with copies of the Stanford press release on this.
    These studies show that it truly is “all in our heads,” meaning brains, with scientific research as the underlying basis for the findings.
    I’m sending out Stanford’s statement on this as far and wide as I can. It’s very important. It counters the smoke-and-mirrors approach and psychobabble, and shows real scientific endeavors.
    Let’s saturate these people with this research conslution.

  11. Michael Allen says:

    This is truly awful. I can only second Mary and Pat’s well-put critiques.

  12. Darlene Prestwich says:

    Do we know if the few minutes allotted for discussion will be open for much/any public input? If so, many of us will be sending prayers, positive energy, or whatever kind of support we can to those brave advocates who will be sacrificing so much to be there.

    It’s so discouraging that the most promising studies were excluded from the study, while PACE and the like were admitted even though they were clearly labeled as problematic by the review itself. Sigh.

    I sure wish there was a way to put the ‘jury” through a good old fashioned voir dire process.

    • Jennie Spotila says:

      I completely agree we need a voir dire!!!!!!

      The public discussion time is first given to the Panelists to ask questions. Then it becomes open mic. We don’t know how/if they control who gets to speak and how frequently.

  13. Pingback: P2P draft agenda is now available | Speak Up About ME

  14. Ren says:

    Do the lumpers consider psychosurgery/neurosurgery to be an innovative treatment/symptom management tool for individuals with ME/CFS? (Fibro? GWI? Lyme?)

    Historically, psychosurgery was in part promoted as an economic solution to health care burdens. Twice (but often more) as many women as men were lobotomized (J. Pressman). Lobotomy became more common with returning WWII soldiers, and “About 12 percent of all lobotomies were performed in Veterans Hospitals…” (E. Valenstein). The 1949 Nobel Prize in Medicine was for lobotomy. “Scandinavian hospitals lobotomized 2.5 times as many people per capita as hospitals in the US…mainly women.” (Wiki). Swedish records suggest overcrowding contributed to frequent use of the procedure (K. Ogren).

    In 1972/3, Michigan (lost but) sought to study behavior modification (particularly aggressive behavior) and psychosurgery using individuals held in state ward. The project’s chief neurologist (Ernst Rodin) allegedly advocated psychosurgery as a means to prevent riots like those in Detroit (Breggin.com, http://videocast.nih.gov/pdf/ohrp_psychosurgery.pdf, http://www.amazon.com/War-Mayhem-Reflections-Viennese-Physician/dp/1552122905).

    Fast forward–2000s, and psycho/neurosurgery research is here again. Cingulotomy for chronic pain, depression, anxiety disorders, OCD, addiction/substance abuse, anorexia, and aggressive behavior disorder (this last – performed (in Mexico?) for economic reasons and without patient consent. http://www.academia.edu/4754621/Surgery_for_aggressive_behavior_disorder).

    A “noninvasive cingulotomy, a surgical procedure occasionally performed to sever white-matter connections to the cingulate and provide pain relief to patients with intractable, chronic pain” has been tested as a treatment/symptom-relief method for individuals with fibromyalgia (rheumatologynews.com).

    Aetna insurance lists “somatoform disorders” with conditions for which cingulotomy is considered experimental/investigational. Aetna refers to the “Consensus on guidelines for stereotactic neurosurgery for psychiatric disorders”: “Nuttin and associates (2014) noted that for patients with psychiatric illnesses remaining refractory to ‘standard’ therapies, neurosurgical procedures may be considered.” http://www.aetna.com/cpb/medical/data/200_299/0288.html

    Nuttin et al. (2014): “a substantial minority of patients either does not respond, fails to sustain response, or experiences unacceptable adverse effects. It is for these patients who are even more at risk with nontreatment that the use of neurosurgical procedures…may be considered.” http://jnnp.bmj.com/content/85/9/1003.full.pdf+html

    Shah et al. (2008) on functional neurosurgery: “patients must meet operationalized criteria for severity, chronicity, and disability and have a demonstrated inability to respond to standard available treatments, including psychopharmacology and psychotherapy.” http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2687086/

    The 2011 CFS grant review roster included a cingulotomy researcher (J. Greenspan) (PR, 2011).

    Valenstein (1988): “When I began to summarize the factors responsible for the proliferation of lobotomy it became evident that all of them still influence the practice of medicine… desperate patients.. unreliable claims of cures.. flawed data… desire for “name and fame.”…media… Economic pressures… Competition between medical specialties.. and physicians and hospital administrators continue to search for new applications for new procedures once the staff and facilities are in place. It is even possible to argue that some of the factors that shaped the early history of lobotomy are more influential today.” http://quod.lib.umich.edu/m/mqrarchive/act2080.0027.003/66:12?page=root;size=100;view=text

  15. cort says:

    I think this is an important, and as I said unsettling review.

    I have some questions about accuracy of the following sentence, though, referring to the AHRQ review that states that it ” ignored all of the most promising biomarker and treatment research.”

    “Ignoring” implies that the AHRQ panel saw the evidence and decided in a cavalier fashion to ignore it. Using that word plays on suspicions that federal groups are just against ME/CFS – that they just want to ignore anything that validates his illness.

    Instead, the panel examined and then decided – based on standard parameters – whether to include a study or not. That is very different context to view the report from than a group that just”ignores” the best biomarker and treatment studies.

    • Jennie Spotila says:

      I see your point, Cort. I did not intend to imply some kind of conspiracy.

      But the “ignoring” in this case came in the form of the standard parameters they set for the review. The PICOTS study protocol set forth the criteria in advance, which is the appropriate thing to do, and then they applied those criteria. BUT – and this is really important – they made two decisions as part of that protocol which prevented much of the research from being considered.

      First, they decided not to look at any study “intended” to investigate etiology. This begs the question of why a study’s “intent” is more important than the “data” it produced. By making that choice, they ignored all the biomarker evidence. They ignored it because they had decided not to look at it – before they got started. SMCI protested the study protocol for this reason – it was set up in such a way that much of the physiological evidence was not going to make the cut.

      Second, they made the decision to require that treatment be given for at least 12 weeks for a study to be considered. This meant that much of the treatment literature was excluded. Rituximab was excluded even though that study lasted 12 MONTHS, because the drug itself was administered for less than 12 weeks. Again, this decision was made at the outset, and it resulted in much of the treatment literature being ignored completely, or excluded after abstract review.

      • cort says:

        The pertinent question for me is whether they followed their standard guidelines. If not including studies on etiology is part of their guidelines – that’s one matter. If it’s not that’s another.

        I assume that it’s standard procedure to ignore etiological studies. My guess is that etiological studies probably NEVER include the kind of statistical analyses needed to validate biomarkers – and why would they? They’re looking for etiology – trying to reveal a potential cause – not to use the kind of statistics or include the kind of populations needed to validate biomarkers.

        Saying the etiology criteria knocked out all the biomarker isn’t accurate. That criteria probably knocked out many of them but the AHRQ report listed several reasons for excluding a study from it’s analysis. Etiology wasn’t the only reason.

        With regards to the twelve week argument – I think that was an insightful finding. Again, is it standard AHRQ criteria that the AHRQ uses to assess treatment efficacy? Or is it something they changed for ME/CFS? It “sounds” like it’s probably a standard criteria – they want a certain length of treatment to occur before deciding if its effective.

        It sounds like that criteria just doesn’t work with regards to Rituximab and it slipped through the cracks. That’s too bad, but asking the AHRQ to add to their criteria “duration of treatment effects” is a different matter that goes to how the AHRQ analyses treatments in general – not to how this panel did their work.

        • Jennie Spotila says:

          Cort, I don’t think it is standard guidelines to always exclude etiological studies from an AHRQ systematic evidence review. Nor is a twelve week treatment duration always a standard for an AHRQ systematic evidence review. The decisions on studies to include or exclude are made based on the study protocol for the individual systematic review. This makes perfect sense. For example, if a review was examining the effectiveness of medication for acute pain management after surgery, the duration of treatment should be substantially shorter than 12 weeks.

          The study protocol for our review was published in May 2014 and is still available here: http://www.effectivehealthcare.ahrq.gov/ehc/products/586/1906/chronic-fatigue-protocol-140501.pdf This is where they list the criterion of twelve weeks continuous treatment, the statistics to be reported for diagnostic studies, the outcomes measures for treatment studies, and so on. Based on that protocol, SMCI wrote to NIH in late May or early June expressing concern that biomarker studies would be excluded from the review.

          We agree that the study standards should have been set in advance and adhered to. I think our disagreement lies in where the decision on those “standards” was made regarding this specific evidence review. You are saying you believe those standards are universal to AHRQ evidence review. I am saying that the EPC made those decisions for our specific review. The draft evidence review itself states that the study protocol was developed with assistance of NIH, AHRQ and the Technical Expert Panel. It also states, “Criteria for inclusion and exclusion of studies was developed based on the key questions and the populations, interventions, comparators, outcomes, timing, types of studies and setting (PICOTS) approach.”

          In terms of the etiology studies, this is the line from the review that troubles me: “Articles that attempted to define an etiology on the basis of a biochemical marker or a particular physiologic test were not included in this review because the intent of these was to identify an etiology rather than understand how the specific test could distinguish patients that would respond to treatment.” (p. ES-25) In my opinion, the data reported by the study is what should determine inclusion, not whether the intent of the study was x or y.

          By your reasoning, I’m wondering if you think it’s ok that the Stanford brain imaging study would be excluded from the review? To me, that is precisely the study that the P2P Panel needs to know about in order to make recommendations on the future direction of research.

          • cort says:

            It makes sense that they would have different criteria for different groups. The question is, I guess, whether the 12 week duration criteria was a reasonable one or not.

            I do agree that the etiology criteria is a strange one and I agree with your position on it. I don’t believe “intent” is important at all: the only important matter is whether a study was rigorous enough to possibly identify a biomarker.

            Good for the SMCI to dig deep and query AHRQ on their criteria. In the end, though, the SMCI did not -at least in their blog – take the AHRQ to task for the etiology or other criteria. Instead, they mostly focused on the shortcomings in the ME/CFS field that the report exposed and need to be corrected.

            The Stanford brain study did include the type of statistical analyses they cited, but it did not include patients with a similar type of disorder and it was very small. I don’t think the Stanford researchers believed their pilot study could form the basis for a diagnostic biomaker. They stated bigger studies were needed to validate. So – no it wouldn’t have made it into the final analysis and it probably shouldn’t – because it was too small.

            The next one should, though…. 🙂

            I do think the report in the end will be a positive because it pretty clearly delineates standards – gold standards, really – for acceptance in research. Whether the ME/CFS field will be able to meet them in another story.

          • Jennie Spotila says:

            On the reasonableness of the 12 week duration, I agree that the treatment study should last at least 12 weeks. But the evidence review required the treatment itself to last 12 weeks. That’s why the rituximab study, which lasted twelve MONTHS, was excluded: because the drug itself was not administered for 12 continuous weeks. I disagree with that determination.

          • cort says:

            It was unfortunate, really unfortunate, the Rituximab study was excluded. In retrospect it would have been better to have the criteria you suggested.

    • Anonymous says:

      Having read and worked on similar non-ME/CFS reviews in the past, there is no “standard” criteria that AHRQ or anyone needs to adhere to. However, one major weakness of the AHRQ process is how much ME/CFS experts had a say in determining the criteria. For instance the outcomes AHRQ required for a diagnostic study were things like sensitivity, specificity, area under the curve,etc. While these are not unusual outcomes for diagnostic studies in other fields, in ME/CFS as well as other fields where the data is relatively early (and underfunded to boot in ME/CFS), most ME/CFS experts or people who follow the field would know that the majority of ME/CFS literature does not include these outcomes so by only using them, the AHRQ staff have effectively cut out a lot of the work that has been done over 3 decades. On the reverse side, my group submitted articles that had these outcomes for ME/CFS but which the AHRQ panel did NOT include in their review at all — they weren’t even listed as excluded.

      The problem with requiring that “12 weeks” of treatment is needed is that there is a presumption already that long-term treatment is needed. While that might turn out to be true, what if there was a treatment that took less time or only required a one-time short application to cause positive benefits for a subset of patients? Those studies would be excluded. Generally, in medicine, shorter-term or less frequent treatments that are equally (or even more) effective are favored over longer-term, more frequent treatments as the former is usually cheaper and exposes patients to less risk of side effects. The point of a systematic review is to do a through search to assure that such treatments are not missed, especially since the title of the review includes “treatment of ME/CFS”, not “long-term treatments for ME/CFS”, so setting up such criteria biases the process.

      My belief is the criteria were structured erroneously and what they actually meant was that FOLLOW-UP (not treatment duration) should be at least 3 months in a trial. Longer follow-up makes sense for what we know to be a chronic illness but not pre-determining the length of treatment.

      • Jennie Spotila says:

        AHRQ has said that the Technical Expert Panel included ME/CFS experts and two patients. We’ll get their names when the final report is published in December. Based on what I’ve heard from sources, I’m not confident that the Evidence Practice Center really took the TEP’s advice.

  16. kathy d. says:

    We have to insist on “Science, not politics!” in this, as in all similar issues.

    • Ecoclimber says:

      You are right. This has nothing to do about medicine or medical research. It has everything to do about politics.

      We don’t need another ‘Nurse Ratched’ doctor dictating the dismissive, arrogant and condescending policies toward the ME/CFS & Fibromyalgia patient groups.

      You have to find the cause before you begin treatment. That’s basic science. The psychosocial model has never been scientific. They cannot produce one organic biomarker to validate their hundreds of modalities that border on quackery. How many diseases have they managed to cover up over the years while patients suffered? Their manipulation and obfuscation of statistical datasets, refusing to release their datasets, magically inventing new labels for various behavior actions without any credible scientific research only reinforces a form of quack science that defies description.

      Tell that to the LBGT group who were labeled with a psychological disorder only to be suddenly cured by a culture renaissance. Suddenly, their psychological maladaptive disorder disappeared without explanation of prior diagnosis. How about missing the mark on ulcers and MS (restless legs)? The psychobabblists will soon have their shamans, gurus, crystal and aura practitioners, eastern meditation experts, hypnotherapists, past lives regression therapy, EFT and many more weird and off the wall modalities practicing over a vulnerable patient population with their woo woo pseudo-science while shoving tranquilizers down the throats of patients at the behest of the pharmaceutical industry.

      Their stupidity in unscientific methods that relate many of the causes of ME/CFS and Fibro to childhood sexual trauma, poor potty training etc. defies the common sense and clear logic and draws the conclusion that this is just junk research that fails to rise to the level of scientifically credibility.

      Their smoke and mirror research and sleight of hand by manipulating cohorts depressed people to be included in studies with ME/CFS patients so as to skew the results to show improvement of their therapeutic technique of CBT and GET with depressed people not ME/CFS patients. 7 minutes on treadmill cures patients with ME/CFS. Try finding work with that criterion.

      Any normal person using simple common sense and logic knows that it is not psychosocial somatic disorder after reading about patients’ history. A patient population consisting of nurses, doctors, medical researchers, psychologists, professors, Gold Medal Olympians, NY Times Bestselling authors, teachers, lawyers, athletes etc. suddenly are suffering an extreme debilitating disease after a post viral infection or trauma and (note this) without any prior history of psychiatric disorders, one can only come to one logical conclusion…Occams Razor.

      It is an organic disease. Any other conclusion is irrational, illogical and void of any common sense. Those who make such claims should seek psychiatric help for their intransigent position on defending a position that has no merit in scientific research. Hypothesizes constructed on a sieve of modalities based on tainted Freudian misogynists viewpoints and 18th century technology and science is flawed pseudo social science not medicine. For some strange reason, psychiatrists seem bent on taking a time machine back to that era to develop some of their off the wall idiotic theories.

      Do you know that the majority of worlds main line researchers at the most prestigious research institutes believe in an organic etiology for ME/CFS? …Ian lipkin, Jay Levy, Dusty Miller, Dr. Lights, Dr. Huber, Dr. Montoya, Dr. Ronald W. Davis, Dr. Mario Capecchi, Dr. James D. Watson, Dr. Mark M. Davis, Dr. Hornig and so many more.

      In all reality, the patient community knows that this whole process is not about medicine. This whole process initiated by NIH is about politics straight from the Oval Office.

      Further FOIA, investigations, whistleblower and other lawsuits will uncovered what is taking place behind the scenes of the NIH, CDC and the White House especially with the medical, health and disability insurance industry and their lobbyists.

  17. Nancy Blake says:

    I have already left my predictable comment on Cort’s blog – it is all a continuation of the campaign by the psychiatrists which has been so successful in the UK – to carry out the intention made clear in the letter from Strauss to Fukuda that appeared recently – to get rid of ME as a separate clinical entity. In the UK, there has been consistent refusal to review the NICE Guidelines for ME/CFS, which pay lip-service to the idea that it is a ‘real’ illness, but go on to provide CBT and GET as the only ‘evidence-based’ treatments. They say that in the past 10 or more years, there has not been any research evidence to challenge this view, and go on to point out that biomedical studies have been excluded because they are small, or are ‘laboratory’ studies. Am I confused in thinking that much, or most biomedical research involves laboratories? (Or that without public funding, most studies will be ‘small’?) But of course, ‘should any research evidence appear, they will be happy to consider it.’ The Guidelines have now been put on a ‘static’ list, which will not be reviewed again for years. Does this treatment of biomedical research sound familiar? Cort points out that if a study was intended to investigate etiology, that was grounds for excluding it. But if we are trying to find out what causes an illness, isn’t that ‘investigating etiology?’ How can we figure out effective treatments for an illness of which we don’t understand the etiology?
    Any other illness – heart disease, malaria, ebola – would any research that was intended to ‘investigate etiology’ be eliminated from an exercise in learning about this illness? This makes as much sense as an exercise to study classification, causation and potential treatment based on the premise that all researchers into an illness be excluded because they might be biased. (But the psychosocial researchers are, of course, not biased.) Sorry, but just because you are a conspiracy theorist doesn’t mean there isn’t a conspiracy.
    And the idea that ‘treatment resistant’ patients should be referred to a mental health facility is validation of a level of medical abuse that is difficult to describe accurately without sounding completely mad. But is there any other situation in which it is considered OK to impose years, a lifetime, of extreme suffering on a person, even a person who has committed a serious crime? We don’t condone torture, and are horrified when we learn of it. But a person who has ME is defined by the fact that exertion makes all the symptoms worse, and those symptoms include pain, sometimes excruciating pain. So treated by GET, the patient will inevitably get worse. This will be defined as ‘treatment resistance’, and used to justify incarceration in a mental facility (shades of Sophia, and now Karina), and the imposition of treatments which will continue to make them worse. For Sophia, two weeks of this was a sentence of two years of further unimaginable suffering and then death. For Karina, a similar fate seems inevitable. I know that everyone reading this will already be familiar with this sad history. And our shrill protests are just considered further evidence of a psychiatric condition.

  18. Andrea says:

    Jennie can you tell me why we can’t have a group like the College of Rheumatology take over ME/CFS like they did for Fibromyalgia? How can advocates, doctors and family members make a positive impact and ask for an Independant review legally?

    • Jennie Spotila says:

      Well, the first issue is whether anyone wants us! PANDORA has been thinking about the question of a practice home, so they may have some insights. In terms of asking for an independent review – this IS what the government sees as a very independent review! I think we will have to ask members of Congress to help us.

      • cort says:

        We got kicked out of NAIAD in the early 2,000’s and stuck in the Office of the Director because we didn’t fit in any Institute.

        What we really need is an Institute of Pain and Fatigue.

        • Ess says:

          What we do NOT need
          is an ‘Institute of Pain and Fatigue’
          — broad-based fatigue to bury
          M.E. further.

          • cort says:

            It wouldn’t bury ME Ess- it would do just the opposite – it would finally provide money to explore it. Right now neither pain nor fatigue or exhaustion or whatever you want to call it gets any money because there’s no Institute devoted to understanding what’s going on.

            So ME/’CFS is put into the Office of the Director and the ORWH – with no budget and abysmal funding…If it had an Institute focused on it – it along with FM, IBS, Interstitial Cystitis, TMJ and others would have a dedicated place for them.

          • Jennie Spotila says:

            On the one hand, MS was not buried when the NINDS was created instead of the MS institute wanted by those advocates in the 1950s. On the other hand, it seems counterintuitive to support a nonspecific institute when we’ve been working so hard to get out of the “just chronic fatigue” bucket. One thing to remember, though, is that pain research saw its numbers increase dramatically after the Pain in America IOM report and a Congressional mandate to address chronic pain. We don’t need a new Institute. If NIH was serious about funding ME/CFS, it could do so right now.

          • cort says:

            Stay in the Office of the Director? At the ORWH?

            My jaw is dropping open. The Office of the Director does not even have a mandate to fund research. It’s job – ” The OD is responsible for setting policy for NIH and for planning, managing, and coordinating the programs and activities of all the NIH components.” We lost four NIH funded research centers when we switched from the NIAID to the OD? And you want to stay there?

            Here’s the mission statement for the ORWH “ORWH stimulates and encourages basic and clinical research on the role of sex and gender in health and disease, and sets NIH research priorities in diseases, disorders, and conditions that primarily affect women.” You notice there’s no direct mention of funding research? The ORWH “stimulates’ “encourages” and “sets priorities” for research.

            Our efforts to get out of the “chronic fatigue” bucket at the OD have bombed out…Our funding is less, accounting for inflation, than it was 20 years ago! Funding for chronic pain is still in the pits. Pain is believed to cost the US economy 500 billion dollars annually and there’s no centralized place to study it. Research is fragmented and you know what kind of progress they’ve made…They’re spending a fraction of what they should on it. FM gets less funding per patient than ME/CFS does.

            We’re in the ghetto at the NIH. We couldn’t be in a worse place.

            The fear of the word “fatigue” must be simply overwhelming to want to stay in the OD rather than in Institute devoted to studying it..There’s really a limited number of very fatiguing disorders (MS, ME/CFS and its allies, primary biliary cirrhosis, some neurological and autoimmune disorders).

            We would have studies comparing these disorders. We would find different sources of fatigue. ME/CFS would get differentiated out quick. We would establish unique pathways for fatigue in ME/CFS (PEM)….

            Sounds like a good deal to me..

          • Jennie Spotila says:

            Whooaaa, Cort. I think you misunderstood me. I said we did not need a new institute. I did NOT say we should stay in the Office of the Director! I completely agree with you that the OD is a black hole. You and I have both documented the funding disaster, and I agree that we get nowhere if we stay in ORWH.

            All I was trying to say was that we do not necessarily need a new Institute, whether it’s “pain and fatigue” or something else. Pain research funding has increased dramatically, without its own Institute, although I agree that it’s not enough as well.

            Does anyone know what it takes to get a new Institute? I’m assuming it takes Congressional support (which we don’t have) and millions of dollars in advocacy/lobbying activities (which we also don’t have). I do not think we can wait until we can get a new Institute, Cort. We need money NOW. We need an RFA now. I know you feel the same.

            All I was trying to say was that if NIH wanted to increase its spending on ME/CFS, it could do so right now and without creating a new Institute. The existing Institutes could pony up, and we could be reassigned to an existing Institute. Whether anyone at NIH wants us is a different problem.

          • cort says:

            🙂 I did misunderstand you and I agree that a new Institute is unreachable and would take years of dedicated effort – which is clearly not happening anyway, and I agree that any money we get not just in the near future but in the forseeable future will come within the existing structure.

            I did an interview with Dennis Mangan – based on that the situation is worse than we think actually. He believes we must be in an Institute to succeed, but who will have us, as you note, is unclear. I’m pretty sure no one wants us…It’s a difficult situation…

          • Jennie Spotila says:

            Cort, are you referring to the Mangan interview you published awhile back or something new?

          • cort says:

            Something new. I’m trying to get in touch with Eleanor Hanna as well.

          • Jennie Spotila says:

            Dr. Hanna passed away several years ago. I think? I’m having trouble finding confirmation of it.

  19. Andrea says:

    Would something like this work?

    I think I mis spoke about an independent review. I meant why can’t we establish our own with the doctors , researchers and patient advocates that wrote the letter to IOM at the beginning of this fiasco? If everyone could work together and fundraise for a project where we establish our own college of experts or advocate to get a college interested do you think it would make a difference?

    • Jennie Spotila says:

      The link you posted isn’t working for me, Andrea.

      Establishing a medical specialty and associated professional academy is a herculean task. The American Medical Association is in charge of maintaining the list of recognized specialties. As an example, the American College of Rheumatology has 9400 members and a budget of about $24 million per year (source: https://www.rheumatology.org/About/Annual/Annual_Reports/Financial_Statements/). The budget of the IACFS/ME is less than 1% of that, I think.

      Again, I’m not sure what steps it would take for us to be adopted by an existing specialty vs. creating our own. But politically and financially it would be a huge undertaking. Perhaps someone from IACFS/ME could be more specific.

  20. Deborah Waroff says:

    It would be great for David Tuller to get another piece on Vince Racaniello’s virus radio show and blog “This Week in Virology.” This one about the Prevention of Science in P2P. This all is the death of science at NIH. The agency is turning its back on science.

  21. Chris says:

    Cort, sorry to niggle, but I think you left off at least two large conditions which engender fatigue–cancer and depression. There are probably more. I think we might campaign to change CFS to just plain Fatigue, and make it clear that while we fully recognize that there are many sources of Fatigue, and we strongly support more research into its etiology, physiology, and treatment, we want our proper and separate category, ME to be also established. Then everyone can forget that miserable name, Chronic Fatigue Syndrome.

  22. Pingback: Falling Behind and Flailing About: the NIH, P2P, Dr. Francis Collins and Chronic Fatigue Syndrome - Health Rising

  23. Annie says:


    Looking at the agenda, this section also particularly troubled me ‘8:50 a.m. Evidence-based Practice Center IV: Treatment: Counseling Therapies and
    Exercise’. Are they still touting counselling and exercise as treatments?

    • Jennie Spotila says:

      Yes. The Evidence Review (which was done by the Evidence-based Practice Center) concluded that it had moderate confidence that CBT/GET are effective in improving fatigue. Three Oxford CBT/GET studies (including PACE) were rated as good quality. The Review made no distinction between the Oxford patients and ME patients in drawing its conclusions about the effectiveness of CBT/GET.

  24. Annie says:

    Also when you wrote above, ‘Instead, this section focuses on studying diseases other than ME/CFS as a way to back into ME/CFS results’, which other diseases are you referring to? Do you mean psychiatric conditions? Sorry a bit confused

    • Jennie Spotila says:

      These three speakers study fibromyalgia and other pain disorders, irritable bowel syndrome, “functional somatic syndromes,” and the predisposing effect of trauma or psychiatric disorders.

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