The goal of the Pathways to Prevention (P2P) program is to… identify research gaps in a scientific area, identify methodological and scientific weaknesses.., suggest research needs, and move the field forward through an unbiased, evidence-based assessment of a complex public health issue. The National Institutes of Health
The expectations for the Pathways to Prevention report were, to put it mildly, low. The report’s reliance on four outside experts none of whom, by design, had any experience with chronic fatigue syndrome raised fears. Fifty-one percent of respondents in a Health Rising poll felt outside experts probably shouldn’t be reviewing ME/CFS. Sixty-nine percent had low trust that outside experts could be objective, and seventy-nine percent had low trust that the outsiders could get major issues right.
After all the worries over whether the Pathways to Progress (P2P) panel – none of whom had any expertise in this disorder – could possibly “get” chronic fatigue syndrome and, in fact, might set it back for decades, just the opposite happened: the P2P panel actually “got” ME/CFS, and they produced a report which, if implemented, would push it forward significantly.
Coming from independent, outside experts and relying in part on another independent review (AHRQ report), the 19 page draft reports findings – that ME/CFS has been understudied, that patients have borne the consequences of that neglect, and that a vast increase in the commitment to understand and treat this disorder is needed – should have all the more impact.
In the end, the data, as Dr. Bateman suggested it would, won out, and Bob Miller’s sense – he was the patient advocate in the early stages of the process – that the panel was listening and working hard ended up being correct.. A review of the first half of the report follows. A review of the critical recommendations section is next.
Medical Community Fails Chronic Fatigue Syndrome Population
The report begins by citing the high rates of disability and economic costs, and then lays the extraordinary burdens people with ME/CFS face directly at feet of a medical community that has essentially failed in its core commitments to assist and provide care.
“ME/CFS is an area where the research and medical community has frustrated its constituents by failing to assess and treat the disease and by allowing patients to be stigmatized.”
Medical Community Neglect Leaves ME/CFS Community with Heavy Burdens
Over the last 20 years, minimal progress has been made to improve the state of the science for patients with ME/CFS, and the public and provider community is frustrated. P2P Report
The panelists “got” to a surprising degree the heavy burdens ME/CFS patients have borne by confronting an often uncaring medical system. It excoriated a medical system that often treats people with ME/CFS with “disdain, suspicion, and disrespect” and considers them “lazy, deconditioned, and disability-seeking”. These outdated and untrue themes, the P2P asserted, have hampered scientific progress and have led patients to be treated inappropriately with psychiatric drugs that have not helped and at times caused harm.
The panel cited the heavy emotional burdens caused by “frequent and negative interactions” with the medical community ME/CFS patients must carry. The stigma that surrounds ME/CFS leads to patients being isolated. Financial distress is common.
The report’s statement that the lack of available medical options “usually”, not sometimes, but “usually” requires patients to “make extraordinary efforts, at extreme personal costs, to find a physician who will correctly diagnose and treat ME/CFS symptoms” indicates that the panel understood how underserved this population is, and provides a strong foundation for the ME/CFS community to press for federally sponsored Centers of Excellence.
Inability to Resolve Fundamental Issues Thwarts Progress
“ME/CFS results in major disability for a large proportion of the people affected. Limited knowledge and research funding creates an additional burden for patients and health care providers.”
The report will assert again and again that the failure to resolve fundamental issues has thwarted efforts to understand and treat this disorder. The inability of the research community to develop “consistent, specific, and sensitive” diagnostic tests and criteria (a definition) has, they stated, hampered all downstream research on pathogenesis and treatment, thereby causing harm”.
Citing small sample sizes, problems with the instruments used to evaluate patients, problems defining ME/CFS patients versus others, the report agreed with the AHRQ draft report’s findings that significant methodological problems have thwarted understanding of this disorder.
[One sometimes wonders what the field has done right :). In the end, though, it’s not the researchers so much as basic elements they’re missing – validated endpoints, well-funded studies, a clear and concise definition – as well as some things they haven’t been doing (specificity, sensitivity, including other disease groups) that are getting in the way of their efforts bearing real fruit. These critiques may be painful, but they do provide valuable guidelines – and they provide issues the ME/CFS community can use to advocate for increased support.]ME/CFS “In”
Addressing the “wastebasket” theme held by many researchers and doctors, the panel simply and powerfully stated, “ME/CFS exists” and referred to it as a “distinct pathologic entity” the causes of which remain unknown.
Oxford Definition – Out
Echoing a P2P panelist’s statement during the recent P2P Workshop that the Oxford criteria should be retired, the panel stated that the flawed Oxford criteria were confounding the science by allowing people with other disorders to participate in “CFS” studies.
Inadequate Research Funding Noted
ME/CFS is an area where the research and medical community has frustrated its constituents, by failing to assess and treat the disease and by allowing patients to be stigmatized. P2P report
The report’s highlighting of “the lack of well-controlled, multifaceted studies using large, diverse samples, and the limited research dollars directed at ME/CFS from both the public and private sectors” should prove invaluable in advocates’ quest to finally get an sufficient federal response to ME/CFS.
Disorder Faces Unique Challenges
Remarking on the “unique challenges to ME/CFS” the panel appeared to understand, as well, that they were dealing with a disorder that faces challenges that few other disorders do. When asked how to foster innovative research to produce treatments they noted that twenty years of research has produced scant progress leaving patients frustrated.
ME/CFS is Not a Psychological Disorder
Patients want … a meaningful recovery (not just incremental improvement) P2P Report
Importantly, they asserted that, while psychological repercussions often follow ME/CFS, it is not a psychological disorder. ME/CFS overlaps with many other disorders including fibromyalgia, major depressive disorder, and a variety of chronic pain or inflammatory conditions. [Finally, inflammatory disorders are included as a co-morbid condition.] Fatigue is an essential component, but does not nearly begin to “capture the essence of this complex condition.”
The panel got the constellation of important symptoms right: fatigue, post-exertional malaise, neurocognitive deficit, and pain. The panel did not [and could not in my opinion given the lack of studies in this area] endorse a single definition for ME/CFS, but their statement that a “clear case definition with validated diagnostic tools is required” will enhance efforts to get the NIH to fund studies to produce a statistically determined research definition that will propel this field forward. Their statement that it is “critical” to include homebound (“non-ambulatory”) patients in studies will, hopefully, spark efforts in that area as well.
CBT/GET Downplayed
CBT and GET….are not a primary treatment strategy. P2P Report
The Panel took the very moderate findings from the AHRQ draft regarding CBT/GET and moderated them even more, stating, in what will be music to many ears, that because neither therapy shows improvement in quality of life, they should not be considered “ a primary treatment strategy”. (The CDC Toolkit, in the P2P panel’s eyes, now contains no primary treatment strategies.)
Doctor’s Lack Basic Understanding
Doctors lack understanding of basic management skills (pacing, realistic goals, basic rights, understanding of emotions, exercise, relaxation) that can be helpful. Too strenuous exercise programs in the past have turned some patients off to milder, more appropriate exercise regimens (they mentioned stretching) that can be helpful.
Long Laundry List of To Do’s
The laundry list of “to-do’s” for ME/CFS is long indeed and feature basic research elements this field has not yet produced or hasn’t had the money to utilize. Standard and validated tools and measures are missing, studies are too small to identify subgroups, endpoints need to be clarified, and clinically meaningful symptoms are not being assessed.
In perhaps a critique of the European emphasis on behavioral studies, they noted that the biological factors causing and promoting ME/CFS are often neglected in research studies.
Promising Avenues for Future Research Cited
In contrast to the AHRQ’s report that simply wiped out most ME/CFS research findings because of methodological problems, the P2P draft report asserted that “strong evidence” indicatesthat the potent avenues for future research include the immune system, metabolism (exercise), the mitochondria, neurotransmitter signaling, and the microbiome [but not the autonomic nervous system?].
Their call for large, multi-center studies with diverse groups of patients (to replace the small studies typically done now) can only help advocates’ efforts to increase funding.
Research priorities should focus on finding biomarkers and developing treatment options. Key research needs include:
- Determining the pathogenesis of ME/CFS, in particular the role herpesviruses and other viruses play in triggering the disorder is critical. Encouragingly, the authors plucked out the role infectious mononucleosis (IM) plays in adolescents. (This should be included to include the role IM during adolescence plays in adults coming down with ME/CFS later.)
- Understanding that the genetic predisposition present.
- Is ME/CFS a spectrum disorder?
- Are different pathways responsible for different symptoms?
Conclusion
“We noted … the limited research dollars directed at ME/CFS from both the public and private sectors. P2p Report”
In a surprise, the panel of outside experts – none of whom had any experience with ME/CFS – mostly “got it” about ME/CFS. Any report will have shortcomings and this one will as well, but the list of ways the panel got it right is impressive. The report suggests that, given enough time and information, outside experts can be trusted to understand.
Halfway through the Pathways to Prevention report, it’s identified many barriers to progress and has provided the ME/CFS community ample opportunities to press the federal government for change. The panel is in agreement on many longstanding issues that advocates have asserted plague ME/CFS, including paltry public and private research funding, lack of knowledgeable doctors, poor patient care, and a stigmatization of ME/CFS the medical community has fostered and allowed to continue.
The report downplays the significance of CBT/GET treatments, states the Oxford Definition is causing more harm than good, and, in agreement with the AHRQ report, provides a list of basic issues that need to be resolved. The future research section missed some points (such as the autonomic nervous system) and may have over-emphasized others, but it always focused on pathophysiology.
The report got the major issues right. We’ll see how they do in the all important Future Directions and Recommendations section next.
Cort, thanks so much for this really clear summary of the report. This is good news, particularly for the many of us who have been dealing with this situation for decades now. It seems as though this report will give us all a way to approach the governmental component of the research community in a matter-of-fact way, with this report in hand. How can we leverage this information? Is anyone mounting a campaign to do so? Has anyone followed up on Ian Lipkin’s suggestion that we get 15 congresspeople to advocate for us? This would be great timing to do so. Are there any efforts in the works?
I’m sure there will be efforts in the works. This report will only help. How much it will help will depend in part on what their recommendations are, I’ll check those out in Pt II.
https://prevention.nih.gov/programs-events/pathways-to-prevention/workshops/me-cfs/workshop-resources#archivedvideocast
Tammy and any others, you can find out here how to comment on this draft report. We are all invited to do so within the next few weeks, referring to the line number of each statement we wish to comment on.
Cort, I have a similar reaction to you on this draft report and additionally appreciate that you mentioned the absense of autonomic dysfunction in the future research section.
Dear Cort, all of us who have been “out of life” for so long now, would just love for this recognition and research. Especially now with Dr. Lipkin interested we could really get somewhere but he was turned down for that grant from NIH I believe. We all go up, then down, and over and over but we all still HOPE. YOU ARE AN ANGEL TO ASSUME THE ROLE OF MESSENGER . SINCERELY, JAVEN HIPJAVEN@gmail.com
The panel clearly took the Workshop presentation on the microbiome to heart. The recommendations section is critical, though. The panel did a good job on explicating the needs of the ME/CFS but I don’t believe the recommendations section fulfills the promise of the first section – it will need some work
Yes, yes, yes! You ARE an angel to assume the role of messenger! Thank you, Cort!
I WANTED TO SAY QUICKSILVER MESSENGER. SINCERELY, JAVEN
After 20 years of this illness…music to my ears! Thanks,Cort, for an excellent summary.
The report says DRAFT Executive Summary, anyone know if this is the FULL draft report, or is it just a draft of the executive summary? If the later, will the full drat report be published? Seems the clock is already ticking for comments.
I don’t know…..I think we have until mid-January ,which is good because several important recommendations needed to be added to the report, I believe.
Thank you Cort for a thorough and well balanced analysis of the P2P draft.
Thank you Cort for this good news. I’m especially impressed that they have put the Oxford criteria to bed along with CBT and GET. The UK will be pleased.
Ann
Hi Cort,
Thanks Cort.
I am so encouraged by this news! About time we start turning this ship around, right?
I want to thank all those who I know were working for months in preparation for this event and for all those who spoke on our behalf. I also want to thank the committee for “getting it” like you say.
It obviously was worth the time and effort, but I hope the patients who participated do not decline in their health status for Christmas time due to the work and travel they had to do.
For all those who were at home hoping and praying that this would come out more positive than negative, I also think this also helped.
Let’s keep it going. Leaving this very challenging year for ME/CFS behind and moving into a more hopeful future is a great way to start 2015.
Beautifully expressed, Valerie!
Yes, thanks, Valerie. You said my thought also, very well.
Cort,
We patients have always known that ME/CFS is “gettable” when people care enough to look closely. Thanks to your tireless advocacy, our message is being heard and the right people are looking.
At the risk of sounding like a spoiled child who wants more, more, more – Is Compassionate Care, which would enable us to try medications prior to large-scale trials, being discussed in any of this?
Thanks!
Thanks Sue – I had never heard of compassionate care – we’ll see if they include it in the recommendations.
I do believe that once people take the time to learn about ME/CFS they usually “get it” and become allies. I’m not done with this report but it’s the second one, after the FDA report, in which the feds appeared to get it.
Maybe we should have everyone in the NIH do a crash course in ME/CFS 🙂
Cort, the term, Compassionate Care, has been used in regard to medical marijuana’s use, especially for children and adults who suffer from epilepsy and other nerve-related conditions.
Thanks, Cort, for your terrific explication (and inclusion) of the draft report. I want to say how glad I am to have been just plain wrong in my strident doubts about the possible efficacy of the P2P. This incredibly encouraging news feels like a glimmer of light in the long darkness (though I think it is tough for so many of us truly to trust in an effective outcome, with our old, many-times-battered hopes, sigh…).
Re Tammy’s reminder of Ian Lipkin’s suggestion of garnering 15 congresspersons in our corner, I’d like to recommend bringing ourselves to the attention of (for one) The Honorable John Lewis of Georgia’s 5th District, a young hero of the Civil Rights Movement who for many terms in Congress has given the good fight for all human rights. I plan to write to him, once I’ve managed the full report (and the holidays).
Great report Cort. Do you think the contents of this report has anything to do with a 3-hr Telephone CFSAC Meeting Announcement coming in Jan, 2015? There are many things I am encouraged by from the P2P report, my only concern is that the people who have been preventing our progress in treatment are still the same gatekeepers we have not been able to trust to see that our best interests are progressive. How would you suggest we address this in our reply to this P2P Report.
On the first day of the P2P presentations, those present were told if there were any additional comments that someone would like to contribute that there were computers set up in the outer hall to submit those statements. Apparently four people submitted comments because on the second day Dr. Greene stated that the comments submitted on the first day were deleted, and if someone wanted to submit their statements a second time that they should return to the computers outside. She did not say what happened that the comments were deleted? How are we to know if our commentaries back to the P2P Panel will all be provided to them; or, if the Team who were selective in providing the research studies will also be selective in the feedback that is submitted?
I do respect the Panel who was provided “select” studies, and then had two days of seriously overwhelming information presented to them by leading Scientists, Treating Physicians, and Patients to develop these conclusions in such a short time. It is good that they heard, and interpreted our pleas as they did. Hopefully it can only get better.
Without an accepted definition of the disease, ANYTHING that comes out of this ill-designed process can be challenged and nullified in the future. They might as well be defining the travel rules for the tooth fairy.
The ONLY way anything positive can come out of this is a statement to the effect of: “After reviewing the available disease definitions and in consideration of the recommendation of experts in the treatment and research of this disease, we are recommending the Canadian Consensus Criteria (CCC) be accepted and approved. As such we recommend that the name of this disease, as defined in the CCC, be referred to as myalgic encephalomyelitis (ME).”
P2P – a disgrace and a failure
another death sentence for ME and CFS patients. The research findings of Myhill, Peterson, Cheney, Montoya, Lerner, Klimas, Connolly, Behan, Richardson, etc. totally ignored. No discussion of ICC and known diagnostics which have proved effective.
Cort, the P2P was a disgrace, a failure. No acceptance of known diagnostics and ICC, and no hope for ME and CFS patients. A death sentence for many patients. Be honest, Cort.
I read a report that axed the Oxford definition, recommended a process to create a new definition, emphasized that pathogen and immune and mitochondrial and neurological research (Peterson, Montoya, Lerner, Klimas, Myhill, Behan) should be a priority moving forward, acknowledged ME/CFS has been neglected and and on and on. I think that’s significant progress – not a death sentence. I think we’re in pretty good shape with this report.
I am wondering how this information will get to primary care physicians. I have moved twice in the past four years. I was told by my PMC in Arkansas that I would not be able to find a single doctor in the entire state who would treat me. I am now in Reno and have visited one PMC who said in no uncertain terms that she did not treat CFS/ME.
I have been following the progress in CFS/ME and Fibromyalgia since I got diagnosed in 2004. The climate has become very political. Any time this happens progress…real progress…tends slow slow, if not halt completely.
Is there a plan for educating doctors on the findings of P2P?
Thanks, Cort. I, too, was pleasantly surprised that the report was not as bad as expected. However, I’m not as positive as you are (surprise! 😉 )
I see a huge red flag with ‘multimodal’ therapy being so highlighted in the report (mentioned several times) and a ‘multidisciplinary care team (e.g., physicians, nurses, case managers, social workers, psychologists)’ being recommended.
This is very much in line with the general current thinking on syndromes with ‘diffuse symptoms’ and the recommendations made by the psychiatrists wishing to label many conditions as Bodily Distress Syndrome. It is not a viable way forward for ME/CFS research or care. As other very wise people have commented online, it is a way for doctors to get ME patients off their hands, and once the team is created with nurses, physiotherapists, psychologists, etc, this team is going to want to prove that their therapies are useful in ME. We end up with a new version of the CBT-exercise model.
Multimodal treatment is also being promoted as a therapy for chronic pain. See for example:
https://clinicaltrials.gov/ct2/show/NCT02248363
“Multimodal rehabilitation (MMR) distinguishes itself as an interdisciplinary-coordinated (e.g., physician, occupational therapist, physiotherapist, and psychologist) intervention using a bio-psycho-social view of chronic pain.”
I think we really need to try, through our comments, to get ‘multimodal therapy’ out of the report, as well as the current version of multidisciplinary team. What should be recommended, instead, is biomedical research and biomedical specialist care for ME/CFS patients. There should be multidisciplinary teams, but they should consist of immunologists, rheumatologists, neurologists, experts on ortostatic issues, etc. Centres of Excellence where patients could be referred and biomedical research organized are crucial.
The multimodal model mentioned in the draft report has been applied to ME in a few places in Scandinavia, among others Stockholm, Sweden. In Stockholm the Health Board decided to see if the health care needs of ME patients could be met by a multimodal therapy model. They initiated a project with a multi-team, involving nurses, physiotherapists, psychologists, social workers. Now, around 5 years later, the project has been evaluated and it has been concluded that this model did not at all meet the needs of the ME patients. The treatment model was very similar to the CBT-exercise model. Many patients actually experienced deteriorated health.
In Stockholm, there is now agreement between the multi-team project management and other caregivers, patients and politicians that the multimodal model did not serve the ME patients well. Instead, what is needed is biomedical specialist care. While psychologists, social workers, physiotherapists can be useful for ME patients (if they are knowledgeable about the biomedical disease mechanisms in ME, PEM, etc), the money is much better spent on a multi-disciplinary team of physicians, including a neurologist, an immunologist/infectious disease specialist, a rheumatologist, etc. The politicians in Stockholm have announced that a new ME centre will be established, focusing on biomedical specialist care with only one nurse/administrator and all the other resources spent on ME knowledgeable physicians.
From the report:
113-116 Existing treatment studies (cognitive behavioral therapy [CBT] and graded exercise therapy [GET]) demonstrate measurable improvement, but this has not translated to improvements in quality of life (QOL). Thus, they are not a primary treatment strategy and should be used as a component of multimodal therapy.
303-306 We believe ME/CFS is a distinct disease that requires a multidisciplinary care team (e.g., physicians, nurses, case managers, social workers, psychologists) to optimize care. Thus, properly training that workforce is critical
350 Future treatment studies should evaluate multimodal therapies.
370-371 We believe there is a specific role for multimodal therapy.
Thanks Anne for all the info. I think it’s probably inevitable, however, that any outside panel with come to similar conclusions because with all the studies done in that area. I don’t think we have a chance of getting it out of the report but we can focus on ensuring that biomedical research comes first. I think it’s pretty clear that the panel feels that way as well.
Perhaps we can do that by noting the need for, as the report stated, real treatments not management or small improvements. We know what CBT can do and it’s been found wanting. Now we want treatments that provide significant improvements.
Since the panel was very clear that these are not to be considered primary treatments I don’t see a danger in doctors handing off patients to psychiatrists based on this report – far from it – the report emphasizes pathophysiological research at every turn.
I see a danger in the emphasis on ‘multimodal therapy’, definitely.
They are recommending that treatment be organized in the form of ‘multimodal therapy’ – this is dangerous in the possible establishment of Centres of Excellence. If they are created according to this model with psychologists, physiotherapists, social workers, etc, they won’t be what we need. (This is what has happened in Stockholm.)
They are also recommending that research money be spent on evaluating multimodal therapies – this is dangerous, since we need whatever funds there are to be focused on biomedical research.
But hey, there are no studies on multimodal therapy in ME/CFS, are there? There’s no science backing this, I think ‘multimodal therapy’ is just the buzz word of today, like CBT was a few years back. The CBT model did us a lot of harm, and the multimodal model can set us back just as much – it all ends up being a form of CBT-exercise program.
Quoting Cort Johnson in his reply to Kathleen O’Connor above:
“Hey I’ll take that death sentence any day :)”
Cort, please show Kathleen some respect and allow her to make a comment on your blog without mocking her words and putting a smiley face after it. This is not a game, it is serious business with major repercussions on our lives. Yours included, so why the glib tone? I do not understand how you can be that confident in how the NIH, HHS, our medical practitioners, congress, the general public, and insurance companies will view this hastily thrown together report by 5 non-experts. I am not comforted by the report, and I certainly wouldn’t gleefully “take it any day.”
I, for one, am interested in hearing more from Kathleen and others who are dubious about this report specifically, and the NIH in general, considering their behavior toward patients (see FOIA documents obtained by Jeannette Burmeister) during the P2P/IOM process they are forcing upon us (yes, forcing). But your disrespectful reply toward Kathleen discourages comments from those who disagree with your optimistic positions.
My opinion after reading the P2P report was that it lacked any cohesive direction, and it failed to put any urgency into a very urgent situation. If anyone in government or medicine actually relies on this document, they would spin their wheels for years trying to figure out where to even begin. That is downright scary. Begin with the CCC now! No, it’s not perfect. But it would move science forward for us, so say over 50 of our experts.
The NIH is playing a game with us, and we will suffer longer. Why should they continue to burden us with report after report that requires us to educate non-experts? Our health can’t take this! Why can’t they accept what our experts have already put forward?
We need to demand, as a patient community, that NIH stop playing games, and embark on a mission to EXPEDITE the recommendations of our experts to adopt the CCC as a starting point, and then urgently allocate generous funding toward clinical trials of Ampligen, Rituximab, and other immune modulating drugs and fund biomedical research projects such as Ian Lipkin’s microbiome study and the End ME/CFS project (and many other quality proposals out there waiting for money), and conduct this research using CCC cohorts until that criteria can be updated.
Our lives are at stake. Careers, hobbies, and friends long gone. Our kids are sick, or we are sick, and our kids are growing up without a healthy parent, or we are too sick to even have kids.
WHERE IS THE URGENCY? It is not in this P2P draft, and it is not currently in the NIH’s actions, UNLESS WE DEMAND IT.
This is no laughing matter.
Tom Jarrett
I agree that this is a serious subject and that’s why I kind of fobbed off Kathleen’s comment. For me it so little represented what was in the report that I question how thoroughly she read it – how serious she is being.
I think if read if you read the report you’ll see that it’s first recommendation is a committee that produces a consensus on a temporary definition and then develops a national and international research network to define it.
The report also suggests the NIH should prioritize microbiome, immune and other biomedical research.
I agree the report lacked cohesion and could have been done better – however that doesn’t mean this report is not a very significant step forward. The panel actually puts forth so many suggestions to fill the many holes in ME/CFS research and treatment that it may be difficult to know where to begin.
I do agree that specific funding targets need to be added to the report and the recommendations could be significantly strengthened.
With regards to urgency the report states this: “Innovative biomedical research is urgently needed to identify risk and therapeutic targets, and for translation efforts.“ – P2P Draft Report
Please check out Part II of the P2P report and let me know what you think: Report Calls for Significant Expansion of NIH’s Commitment to ME/CFS: Tightening Needed http://www.cortjohnson.org/blog/2015/01/02/report-calls-significant-expansion-nihs-commitment-mecfs-tightening-needed/