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P2P: Taking Shape

June 20th, 2014

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The P2P ME/CFS Workshop has been approved and is scheduled for December 9-10th, 2014. The focus of this post is on analyzing four components of the information released by NIH yesterday:

  • P2P is describing our disease as fatigue, without post-exertional malaise
  • P2P is trying to clarify questions on the multiple case definitions, measurement tools, effective therapies and innovative research methods
  • The P2P agenda uses questions beyond the evidence review, but not the most important question of all
  • The P2P Working Group includes members with and without ME/CFS expertise

 

How Does P2P Describe ME/CFS?

 
Huge red flag, folks. Here is how the P2P website describes ME/CFS:

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a complex, multifaceted disorder characterized by extreme fatigue and a host of other symptoms that can worsen after physical or mental activity, but do not improve with rest. In addition to extreme fatigue, people with ME/CFS may also experience:

Widespread muscle and joint pain

Sore throat

Tender lymph nodes in the neck or armpit

Headaches

Sleep problems

Difficulty with short-term memory or concentration

I added emphasis so you can’t miss the takeaway here. ME/CFS is characterized by extreme fatigue, and people with ME/CFS may also experience other symptoms. And what is missing from this list? POST-EXERTIONAL MALAISE. Even Fukuda lists post-exertional malaise as an optional symptom. But the way NIH has described the disease, it almost sounds like Oxford – extreme fatigue and maybe other symptoms.

The description also states, “sensitivity to environmental factors (e.g., noise, light, chemicals) may force many individuals with ME/CFS into seclusion or withdrawal from society.” These sensitivities can certainly be debilitating, but I think most (if not all) patients would agree that it is primarily PEM and all the other symptoms that keep us imprisoned in our homes or our beds.

Need more proof that NIH’s conception of ME/CFS does not question the assumption that they are the same fatiguing illness? They say the two names are for the same condition: “The name myalgic encephalomyelitis or ME is more commonly used in Europe and Canada, while the name chronic fatigue syndrome or CFS is used more often in the United States and Australia. Yet the acronym ME/CFS is increasingly being used worldwide.”

In all fairness, these descriptions do not automatically determine what the Panel’s report will say. But the paradigm of a single, fatiguing illness has been at the heart of my opposition to the way P2P was being put together, and this has not eased my concern.
 

What Will P2P Try To Do?

 
The P2P website describes four things that the Workshop will try to clarify, a weird sort of blend between the five questions presented by Dr. Susan Maier to IOM on January 27, 2014 (after the P2P Working Group planning meeting), and the Key Questions of the systematic evidence review protocol.

The first issue is how the research using multiple case definitions has contributed to the state of the current literature. It’s a good question, but the answer seems blindingly obvious. Perhaps there are more subtleties that outsiders would see that I do not. All I can see is the absolute muck of a contaminated evidence base that counts Oxford studies and CCC studies as one and the same, and has absolutely no consensus on how to diagnose or measure any of it. In my opinion, the use of multiple case definitions is responsible for the state of the current literature, which is why we are stuck in a hellish stalemate with no widely accepted criteria, biomarkers, or treatments.

The second issue is how measurements are able to distinguish among ME/CFS patients focused on subsets by duration, severity, onset, and “nature of the illness.” Two observations. First, what is “nature of the illness”? I do not understand whether this is referring to immunological vs. neurological, or something else. Second, this issue assumes that differences are automatically subsets! This is exactly what I’ve been harping on for months – that the failure to ask if ME and CFS are the same, different, or spectrum illnesses eliminates the most fundamental and foundational question of them all.

The third issue presents a big red flag. It asks how research on “therapies shown to be effective” will lead to an understanding the underlying pathology. What therapies have been shown to be effective? Are we talking CBT and GET? Rituximab? You will get two very different answers about underlying pathology if you consider CBT/GET to be effective instead of Rituximab (and vice versa). Just last week, the Solve ME/CFS Initiative told NIH that the search strategy will bias the evidence towards CBT and GET. If that prediction holds true, then asking what CBT and GET tell us about the underlying pathology is patently dangerous.

The fourth issue asks what “innovative research approaches” tell us about the pathophysiology of ME/CFS and how it can be used to develop treatments. What is an innovative research approach? Is this where Rituximab fits in? Or is this focused more on things like proteomics, microbiomics, or systems network analysis? Or something else? Without understanding the terms or context, it’s hard to tell.
 

Agenda Good or Agenda Bad?

 
You may recall that I got two draft agendas for the Workshop through FOIA. Circumstantial evidence suggested they were drafted at or soon after the January Working Group meeting. How do they stack up to the real thing posted on the P2P website? Answer: the draft agenda I got through FOIA is very very similar to the one posted yesterday.

A few overall observations: The time officially allocated to the “patient perspective” is 20 minutes. The Evidence Practice Center has a total of 1 hour, 20 minutes split between two days. Total time allocated for discussion: 2 hours, 40 minutes split between the two days. You may recall that Dr. Shirley said at CFSAC that there would be town hall-style discussion at the Workshop, and also said there would be “public testimony” but provided no details on that. With less than three hours for discussion, I expect tight facilitation as opposed to open mic. There is no indication of anything resembling “public testimony” as we know it from CFSAC or other federal meetings.

I must call out one change in particular. You probably recall that I have been decrying the framing of Dr. Maier’s overview of the topic, described as “Overwhelming fatigue and malaise as a public health problem.” On the agenda posted by NIH, Dr. Maier still has 20 minutes to present an overview, but that description of the overview is gone.

The five Workshop questions are identical to the draft agenda I obtained through FOIA. Here they are, with their sub-topics (each one gets 20 minutes), but I’ve left off EPC presentations and discussion time.

I.  What is the Incidence and Prevalence of ME/CFS, and Who Does It Affect?
a) Incidence and Prevalence Data (Population-Based Studies)
b) Social Determinants of Health
c) Disease Across the Lifespan

II.  What Tools, Measures, and Approaches Help Define Individuals with ME/CFS?
a) Overview of Existing Tools and Measures
b) Measures: Patient-Reported and Physiologic
c) Measures: Omics, Biomarkers and Imaging
d) Innovative Statistical Approaches

III.  How Are Tools and Measures Used to Distinguish Subsets of Patients with ME/CFS?
a) Identification of Subsets of Individuals
b) Triangulating Quantitative and Qualitative Data (Quality of Life/Function)
c) What Outcomes Represent Improvement, Recovery, Prevention, Benefits, or Harms

IV.  Given the Unique Challenges to ME/CFS, How Can We Foster Innovative Research to Enhance the Development of Treatments for Patients?
a) Incorporating Multiple Study Designs into ME/CFS Research
b) Maximizing Approaches and Results from the Study of Other Illnesses and Complex Chronic Conditions
c) Using Research on Comorbidities to Understand ME/CFS

V.  What Does the Research on ME/CFS Tell Us About the Presentation and Diagnosis of ME/CFS in the Clinic?
a) Lessons from Current Treatments and Clinical Trials
b) Comparative Effectiveness Research
c) Health Services Research and Health Policy Relevant Research

I’m going to wave a few big flags here (you knew I would). First, this agenda does not ask if CFS and ME are the same illness, different illnesses, or different aspects of a spectrum. Does. Not. Ask.

You cannot answer a question if you refuse to ask it in the first place. If we have a pile of apples and oranges and we insist on talking about the incidence and prevalence of a fruit called “appanges,” for example, or the tools that will help distinguish the subsets of “appanges,” are we ever going to question whether “appanges” are actually a pile of apples and oranges????? No, we are not. We will continue to call them “appanges,” and argue about whether the number or shape or color of the seeds distinguishes subsets. We will not see what is right in front of us, because we did not bother to consider that “appanges” might be a made-up category of fruit truthiness.

Second, we keep hearing mixed messages about what this Workshop is really trying to accomplish. Is it to identify the gaps in research, as many people insisted at CFSAC? Is it to identify methodological weaknesses in the research, as Dr. Cook said on Tuesday? Is it to determine what treatment or clinical approach works best? I see shades of all three, with an emphasis on what is known and not what is unknown.

I must correct something I have been insisting was true. I have been saying that the agenda would mirror the questions for the systematic evidence review. That was incorrect. But while the agenda and systematic review questions are not identical, you can draw a lot of lines back and forth to connect one to the other.

When Carol Head (Solve ME/CFS Initiative) expressed concern at CFSAC about the elimination of the question of how CFS and ME differ, Dr. Collins Sharp – answering with the caveat that she is not at all involved in the P2P planning – said that the review questions are a subset of the Workshop questions. She said that any question that did not have sufficient literature to be included in the evidence review could still be addressed at the Workshop. This appears to be the case, but that most important and fundamental question is nowhere to be seen.
 

The P2P Working Group

 
The P2P Working Group is the committee that helps NIH plan the meeting. The Group met in person at NIH January 6-7, 2014 (that meeting agenda has been posted). Before now, the P2P Working Group roster was only available through FOIA. Here’s the breakdown of the full list:

Federal Employees, familiar with ME/CFS (6): Dr. Susan Maier (NIH), Dr. M. Katherine Jung (NIH), Dr. Janet Maynard (FDA), Dr. Eun-Chung Park (NIH), Dr. Leorey Saligan (NIH), and Dr. Mariela Shirley (NIH). The NIH employees are all members of the Trans-NIH ME/CFS Working Group. Dr. Park is the staff member contact for the Lipkin samples. Dr. Saligan’s research focus is acute and chronic fatigue, and he has done sample analysis for Dr. Baraniuk and others. Dr. Maynard is the FDA ex officio to CFSAC, and works in the FDA review division that handles ME/CFS drug applications.

Federal Employees, not familiar with ME/CFS (6): Jody Engel, Deborah Langer, Elizabeth Neilson, Wilma Peterson Cross, Paris Watson, and Dr. Jessica Wu all work at NIH’s Office of Disease Prevention. They also all serve on the P2P Working Group for the upcoming meeting on opioid use.

Non-Federal Members, familiar with ME/CFS (6): Dr. Mady Hornig (Columbia University), Dr. Leonard Jason (DePaul University), Dr. Nancy Klimas (NOVA Southeastern University), Robert Miller (Patient and Advocate), Dr. Peter Rowe (Johns Hopkins University), and Dr. Suzanne Vernon (Solve ME/CFS Initiative) are all familiar to the ME/CFS community.

Non-Federal Members, not familiar with ME/CFS (1): Dr. Carmen Green (University of Michigan) is an anesthesiologist and member of the HHS Interagency Pain Research Coordinating Committee. She is the chair of the P2P Panel.

Several names listed on the January roster (obtained through FOIA) as attending the meeting do not appear on this final Working Group roster. Missing are Dr. Suchitra Iyer (AHRQ), Dr. Heidi Nelson and Dr. Beth Smith (both of the Oregon Health & Science University Evidence Practice Center). I do not know for certain why they are not listed on the final Working Group roster, but they may have attended the meeting to discuss the evidence review questions rather than the planning as a whole.

Another odd omission: at the CFSAC meeting, Dr. Nancy Lee said that Marty Bond had attended “several” of the meetings for P2P. Yet Ms. Bond’s name is not listed on any of the documents posted or obtained through FOIA. So we cannot automatically assume that the only people attending Working Group meetings are the members themselves.

According to the P2P website, the Working Group drafted the questions for the evidence review, finalized the agenda, nominated speakers and panelists, selected the workshop date, and continue to be engaged in ongoing workshop planning. I am hearing conflicting things about that continued engagement and how extensive it will be.
 

Bottomline

 
Based on the information released yesterday, is P2P a worst case scenario? I have a vivid imagination, so I can definitely imagine something worse than this. But is P2P looking good? Absolutely not. If Mary Dimmock and I were writing our letter to Dr. Collins today, I would tweak some sections but all of my objections are basically unchanged.

 

  1. Ess
    June 20th, 2014 at 14:53 | #1

    IOM–P2P — There is NO intent to HELP citizens with ME/CFS. That’s the ‘name of their game’–ohhh, but go thru the ‘motions’–invite input–interesting how that all went with CFSAC meeting charade/fiasco the other day–QUITE a display. B O G U S — every bit of it from TPTB.

  2. Ren
    June 20th, 2014 at 18:29 | #2

    Just as a general observation, it occurred to me (and worries me) that P2P’s definition of ME/CFS seems quite close to that of “chronic multisymptom illness” (CMI). I haven’t looked at the most recent IOM Gulf War & Health, but as described in IOM’s GW&H 2013 (p.23), CMI is:

    “The presence of a spectrum of chronic symptoms experienced for 6 months or longer in at least two of six categories—fatigue, mood and cognition, musculoskeletal, gastrointestinal, respiratory, and neurologic—that may overlap with but are not fully captured by known syndromes (such as IBS, CFS, and fibromyalgia) or other diagnoses.”

    However and additionally:

    “Chronic unexplained symptoms are common in civilians. Such terms as medically unexplained symptoms, medically unexplained physical symptoms, somatoform disorders (for example, somatization disorder, undifferentiated somatoform disorder, and pain disorder), and functional somatic syndromes are often used to describe the disorders of civilians who have chronic unexplained symptoms…

    Such syndromes as irritable bowel syndrome (IBS), chronic fatigue syndrome (CFS, also called myalgic encephalomyelitis), and fibromyalgia often are included in this group of unexplained illnesses…” (p. 22)

    And finally, the IOM report stated that its working definition of chronic multisymptom illness (CMI) above was expanded from the 1998 Fukuda CMI definition:

    “…one or more chronic unexplained symptoms (present for 6 months or longer) in at least two of the following categories: Fatigue; Mood and cognition (symptoms of feeling depressed, difficulty in remembering or concentrating, feeling moody, feeling anxious, trouble in finding words, or difficulty in sleeping); and Musculoskeletal (symptoms of joint pain, joint stiffness, or muscle pain).” (p.21-22)

    ——-

    Thank you, Jennie, for this very-much needed guide through the P2P process.

  3. kathy d.
    June 21st, 2014 at 00:21 | #3

    Very good report and update on what is going on, including the composition of the committee.

    I’m at a loss to guess what the federal and non-federal members who know about ME/CFS will do here. Will they passively let bad judgments go through? Or will they stand up for those of us with this disease? Will they argue out our case?

    Also, one thing that always disturbs me is the term “post-exertional malaise”? What type of “malaise” leaves someone confined to bed, in pain, barely able to get food or take a shower or do any household tasks? It really should be “post-exertional collapse” or “post-exertional relapse.” “Malaise” sounds like one who lies on the couch reading after a hard work week or final exams. It’s a total misnomer.

    And also, the whole problem that the government isn’t (or is barely) doing research. It’s being done a universities and private labs. There is no coordination here. So, while there have been biomarkers discovered, changes in gene expression and brain activity and findings in spinal fluid, where is this being centralized? Is anyone in a governmental agency even examining these findings? It seems uncoordinated and maybe not even centralized as far as scientific findings are concerned.

    Are members of this committee even looking at the scientific findings?

    This is all so frustrating I can’t even keep up with all of this, although I appreciate reading all of it.
    I think the federal government does not want to initiate major research or put in funding for it nor pay more for medical care or disability benefits nor do insurance companies.

    • Jennie Spotila
      June 21st, 2014 at 08:11 | #4

      Remember this committee is the planning group. The only known member of the panel that will actually make recommendations is Dr. Green.

  4. Polly
    June 21st, 2014 at 08:57 | #5

    Thank you so much, Jenny, for keeping the patient population informed on P2P. I read the paragraphs you’ve red flagged, and felt the listed symptoms are so common they could describe anyone in the general population.

    Although dismaying and erroneous, I’m afraid the ship has already sailed with “Fatigue” as its masthead. No amount of letter writing to “stop the P2P” will return this ship to port. As you said, “Is P2P looking good? Absolutely not.” At this time, we must do everything we can to get P2P on the right course. I’m certainly open to suggestions.

  5. June 22nd, 2014 at 19:11 | #6

    I looked up ‘Chronic Multisystem Illness’ a while back, and the definition was nothing like the one provided by Fukuda. The category included MS and lupus –illnesses previously defined as psychiatric! And has everyone seen the letter from Straus to Fukuda, congratulating him on having provided criteria that would, he hoped, facilitate the focus on ‘fatigue’ as a symptoms, and allow the concept of ME, as a separate illness entity, to ‘evaporate’? This is all just more of the same. So – as in the new definition of Chronic Multisystem Illness, if you can’t get rid of it one way, change the definition, or change the name, or do both – as in the evolving definitions of what started as ‘hysteria’ (with Beard and McEvedy, 1970, The 1955 Royal Free Outbreak, a Reconsideration) evolves to ‘medically unexplained’ to ‘functional’….and the name evolves from ‘ME’ to ME/CFS, to CFS/ME, to CFS. The underlying purpose, of course, is always to keep disability payments, from government or private medical insurers, down, by a combination of calling the thing psychiatric, and making disability payments conditional on following treatment programmes which patients can’t follow because they make the illness worse.
    On ‘disappearance’ – a few years ago the CDC site still acknowledged the existence of ME, joined up to CFS. Then when the International Consensus Criteria came out, the site referred only to CFS, but stated that ME was a separate neurological illness – but when you put ‘ME’ into the search line, it brought you back that same page. Now I think you will find that all reference to ME in the CDC information has gone completely. Evaporated, you could say. A name that comes up a lot when following these matters up is that of Peter White – who is employed by Swiss Re, and there is a letter from him to Swiss Re assuring them that Graded Exercise Therapy actually is effective against the causes of the disease. I think both letters I have referred to can be found on the site ‘Health Rising’.
    The set of things this group are going to consider seem clearly framed not to make sense of this, or these illnesses, support research into the physiological nature, and into the possibility of effective therapies. They are vague and pretty much meaningless categories which one can predict will refer to the psychosocial view of ME, the PACE Trial (which will be described as demonstrating the effectiveness of CBT/GET, despite the fact that it can only do so after much fiddling with the figures). If what has happened in the UK is anything to go by, the medical research will be dismissed as ‘laboratory studies’ (the NICE committee considering their guidelines dismissed the medical research in this way – apparently they are only interested in research that hasn’t been done in laboratories (???) – and ‘small, pilot studies’ – since no funding is provided for larger biomedical research projects, it’s going to be like that for quite a while.) I am sure that this IOM thing is predetermined to conclude that CFS belongs in the newly defined CMI category, as a ‘functional’ disorder – because in their report on Gulf War Syndrome, they have already stated that CFS is in this category. This whole exercise is window-dressing for a previously determined conclusion.

  6. Ren
    June 23rd, 2014 at 07:30 | #7

    Sorry I can’t verify the distinctions – but I believe there’s some overlap and/or confusion between chronic multi*symptom* illness and chronic multi*system* illness. (Asterisk added and continued below to help me visually distinguish the two – no overkill intended. : )

    My impression is that chronic multi*system* illness (aka multisystem disorders?) is a category of illnesses/diseases, but that chronic multi*symptom* illness refers to a specific (if vague) condition.

    I’ve caught myself mistakenly transposing these terms, and I’ve wondered if they might be transposed (legitimately or mistakenly?) in some literature/on some websites as well. It seems that multi*symptom* illness could be considered a chronic multi*system* illness?? (I don’t know.)

    I believe the most recent IOM GH&H (2014) has recommended though that the term Gulf War Illness now be used instead of chronic multi*symptom* illness – but I didn’t understand if chronic multisymptom illness was being scrapped altogether or just as related to Gulf War vets.

    Re the P2P blog post, I’d like to add that I very-much agree that the P2P statement: “Additionally, sensitivity to environmental factors (e.g., noise, light, chemicals) may force many individuals with ME/CFS into seclusion or withdrawal from society” – is off base.

    Physical and mental exhaustion (PENE), often in conjunction with increased light/sound sensitivity, as a consequence of physical/mental activity drives people into (holds people hostage in) social isolation.

    (Additionally, there seem to be different definitions for seclusion and isolation, with seclusion being used as a psychiatric term/practice whereby some youth and/or psychiatric patients are *locked* away by authorities. By comparison, “social isolation” is used to describe individuals (often the elderly or those with chronic illness) who experience seperation from society due to physical health problems.)

    Also, P2P states: “All other illnesses with overlapping symptoms must be ruled out prior to an ME/CFS diagnosis.” If chronic multi*symptom* illness still exists as a diagnosis, how can it (when “fatigue” is present) be ruled out for an ME/CFS diagnosis?

    And finally, P2P states: “Lastly, medical professionals disagree on many aspects of ME/CFS, including whether the illness is real, and there is no definitive answer about the effectiveness of current therapies (e.g., diet, use of off-label or experimental drugs).”

    Two last thoughts – at this point, the “whether the illness is real” line just seems like a propaganda tactic of repeating false information. And, if P2P is studying “fatigue” as they’ve said, are they asking then if fatigue is real? What’s the scientific definition of “real”? And re effectiveness of current therapies, it seems obviously biased that the harmful CBT/GET combo weren’t cited as examples of questionable/ineffective therapies.

    Thanks, Nancy, for the info you included – I learned some new things.

    Jennie, I imagine you’ve seen that P2P is requesting literature recommendations from the public , but people are concerned about the parameters they’re using. If you haven’t already done so, might this be something you’d briefly comment on, in time? I don’t fully understand the problem flags with this. (Thank you.)

    PR today: http://forums.phoenixrising.me/index.php?threads/nih-asks-for-public-input-into-me-cfs-literature-search-by-july-17th.31026/

    and from early May (- this looks far more professional than the P2P page): http://effectivehealthcare.ahrq.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=1906#8766

  7. Jennie Spotila
    June 23rd, 2014 at 10:45 | #8

    I agree with everything you said above, Ren. Here’s what I just posted over on PR:

    I just want to throw out a couple of points. I agree with @alex3619 that the rules of EBM are not in our favor, and that the evidence grading happening right now is all behind the scenes (until the review is published in the fall).

    The request for information is written to focus on unpublished clinical trial data. However, Dr. Beth Collins Sharp said at last week’s CFSAC meeting that people could submit other materials as well.

    This evidence review is looking at published literature, but it is also looking at “gray” literature – poster sessions, conference abstracts, etc.

    If you are in contact with a researcher who has unpublished clinical trial data, PLEASE share this info request with them and encourage them to submit. The deadline is July 17, so they have to move fast.

    In terms of assembling material for submission, I know @Tom Kindlon has submitted his harms paper, so that is fantastic. Lori Kroger (PANDORA) is also coordinating an effort to pull materials together.

    A really big concern is the key questions, and the parameters of the protocol. For example, they are looking at clinical trials of 12 weeks or longer. They are only looking at studies with subjects 18 and over, which means some of the orthostatic intolerance work in adolescents will be ignored. And the Solve ME/CFS Initiative has gone on the record to say that the study protocol is flawed because the search strategy is skewed towards CBT/GET.

    I strongly agree with Erica Verillo! They are inviting input, so let’s do it. I don’t care if they get the same study from five different people. I would love for them to get thousands of pages of material. If we can get even a SINGLE researcher to submit unpublished data, that’s a big win.

    I suggest that people not try to assemble a comprehensive citation list. What are the most essential papers/data that address the key questions OR address the gaping holes between the key questions. Focus on that stuff.

    One final note – be prepared to provide public comment on the draft report in the fall. We’ll have four weeks to do it, and I’m confident that we will have a lot to say.

  8. Ess
    June 23rd, 2014 at 14:07 | #9

    P2P–IOM–Why are very ill patients forced to do the work? HHS/NIH/CDC–the answers are with the Int’l ME/CFS Experts and Researchers. They’ve already told you; you completely ignored and disregarded the experts–STOP the IOM–and by extension the P2P–adopt the CCC.

    This is a three-ring circus completely OUT OF CONTROL! A dog chasing its tail orchestrated by HHS/NIH/CDC. Mission–to take ME/CFS nowhere but further ‘under ground.’

  9. Ren
    June 27th, 2014 at 08:34 | #10

    Thanks for the above info. And not to dwell too much on language, but something else caught my eye. Probably nothing but thought I should mention it just as a general awareness.

    A PR thread mentioned a (popular?) UK medical textbook (Kumar and Clark – Clinical Medicine, 2005) that classifies ME/CFS within “Functional or Psychsomatic Disorders: Medically Unexplained Symptoms.”

    Under the further heading, “Perpetuating (maintaining)”, multiple chemical sensitivities (MCS) and CFS (the allegedly preferred and more accurate name for ME/CFS) are listed as “avoidant behaviours.” CFS is also described as a maladaptive illness belief (that maintains maladaptive behavior).

    http://forums.phoenixrising.me/index.php?threads/peter-white-barts-comments-on-draft-nice-guidelines-insight-into-their-views.1239/page-7#post-476654

    From this though, I thought again of P2P’s, “Additionally, sensitivity to environmental factors (e.g., noise, light, chemicals) may force many individuals with ME/CFS into seclusion or withdrawal from society.”

    My concern is that the P2P statement lends itself too easily to the above description of psychosomatic disorders, as described by this UK textbook (to which Peter White was a contributor).

    I wonder, for example, if there’s a difference between saying, “x forces individuals into seclusion” vs “x prevents individuals from (fully) participating in…”

    It’s subtle. Again, I don’t want to read too much into anything. But I don’t want to ignore possible implications/trajectories either.

    • Jennie Spotila
      June 27th, 2014 at 16:49 | #11

      Excellent point. I agree that the “forced into seclusion” language carries overtones of psychosomatic explanations. People in chemotherapy are homebound, too, but I’ve never seen them described as being forced into seclusion.

  10. Anne
    July 3rd, 2014 at 00:36 | #12

    The way its written, as it is published online, as a “research protocol”,
    It violates the 1964 WMA (World Medical Association) Declaration of Helsinki (which has been amended 9 times, last time Oct 2008, and what it is, is : Ethical Principles 4 Med Research Involving Human Subjects.
    Which is all about “Informed Consent.”

    If I was still working as an RN, and I didn’t question this, allowed the patient to participate, and the patient was harmed by GET- bedridden, disabled, or died like Brynmor John in England, My RN license would be revolked and I would get sued because I allowed the patient to participate in something that the patient didn’t have knowledge of all of the benefits and risks of GET.

    Rememeber, – This review is written as a “research protocol!”

    What has been missing, including from the CDC toolkit, Is “Informed Consent” which is even supposed to be given when the doctor gives medical advice prescribes a treatment, or if the patient is participating in research- the good and the bad, benefits and risks of the treatment.

    The Tuskeegee Syphillis Experiment didn’t include “Informed Consent”, if it did, those patients would’ve never participated in the study.

    What is missing is, the risk and proven harm of GET, which even makes the PACE trial an invalid trial because the Wessely school did not get “Informed Consent” from the participants, they didn’t mention the risks of CBT and GET in the PACE trial,, in fact they did even the opposite, they even trained the nurses to be personable, call the patients and send them Christmas cards, encouraged the patients to participate in research that would harm them without telling them that CBT and GET could harm them. The PACE trial violated the Declaration of Helsinki.

    This is supposed to be in the “Methods” section of the systematic review. If you look in the “Methods’ section of the systematic review, there is no mention of ethics committee, informed consent, or Declaration of Helsinki. The authors didn’t include it so we have no idea if it was done, and it is not our job to assume ARHQ did. It is their job to show that they did, which they did not, this is to never be “assumed”.

    The P2P study, the way it is written, as a “research protocol”, is in violation of the Declaration of Helsinki!

    Patient must always be given “Informed Consent” which has become a medical-legal issue, and that includes telling those non medical lay people who are part of that “jury” method the harm of GET to the ME patient , which it does not state in that review.

    The P2P review does not state any of that. If they are going to use “GET” as a therapy on that review, then they must state the symptom of PEM like all the other symptoms that are listed
    there.

    NIH P2P Systematic Review for P2P is Negligent, Harmful to patients and in Violation of the Declaration of Helsinki!

    No excuses or exceptions here! These people have had too many excuses and exceptions for the last 30 years!

    • Jennie Spotila
      July 3rd, 2014 at 12:22 | #13

      Just to be clear, the systematic review is not studying patients directly like PACE did, so there are no subjects from which to obtain informed consent. But you are correct, PACE and other trials have not admitted that GET can cause harm to patients. I know that Tom Kindlon’s article on the under-reporting of harms in studies like PACE has been submitted to the review, and this is an issue that both the review and the P2P Panel must consider.

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