from lookhuman.com
The P2P Workshop agenda focuses on a few broad categories of ME/CFS research: characteristics of the ME/CFS population; fostering innovative research; presentation and diagnosis in clinic; and, tools and measures for diagnosis and outcomes. Yet even with the late addition of Dr. Mady Hornig to discuss the immune system and ME/CFS, the Workshop agenda still glosses over many topics in etiology, diagnosis and treatment. This “science lite” approach will hamstring the non-ME/CFS expert Panel, and practically guarantees deficiencies in the final Workshop report.
It doesn’t have to be this way. The P2P approach stands in stark contrast to the science presented at the 2011 State of the Knowledge meeting. That workshop dove deep into infectious disease, systems biology, immunology, neurology, exercise physiology, diagnosis and biomarkers, and treatments. While there was no panel to produce a set of recommendations, the meeting participants identified a number of opportunities for advancing ME/CFS research, including: define and standardize case definition and terminology; conduct more cross-system research; develop standard procedures and common data elements across the field; address gaps in study design, biomarkers and clinical trials, outcome measures, and reproducibility; create a centralized data repository; and attract new investigators. All of these issues remain unaddressed and unsolved three years later.
Of course, we need not look back three years for examinations of ME/CFS science and priorities. For example, the May 2014 Invest in ME conference focused on autoimmunity, infection, immunological biomarkers, brain imaging, the autonomic nervous system, markers for post-exertional malaise, and diagnostic and treatment strategies. Then there was the March 2014 Stanford ME/CFS Symposium, which examined epidemiology, cytokine and gene expression patterns, cardiovascular aging, MRI and EEG findings, inflammatory/autoimmune profiles, and microbial investigations.
Finally, there was the March 2014 IACFS/ME Meeting: Translating Science into Clinical Care. This four day meeting was even more comprehensive than the 2011 State of the Knowledge workshop, covering immunology, exercise and metabolism, treatments, orthostatic intolerance, pediatric issues, autoimmunity, biomarker and pathogenesis findings, case definition issues, brain function and imaging, and much more. There is a detailed summary available, as well as Dr. Komaroff’s conference summary talk.
Replication of these scientific meetings is not required, or even necessarily desirable, for ME/CFS experts to examine the field and identify research priorities. Each meeting should build upon and expand what came before. But of course, the P2P Workshop will not ask ME/CFS experts to do this.
The P2P Workshop will ask non-ME/CFS experts to identify future research priorities without giving them all the necessary information to do so. All along, we have been assured by Dr. Susan Maier (NIH), Dr. Beth Collins-Sharp (formerly AHRQ), and others that the non-ME/CFS expert panel will receive the evidence review survey of the literature and presentations by ME/CFS experts, and that the two combined will adequately equip them to pronounce judgment on the future direction of ME/CFS research. But this is not the case.
The evidence review ignored or excluded the science on biomarkers, pathophysiology, some promising treatments, and the case definition conundrum. And the P2P Workshop agenda appears to be completely devoid of science on brain imaging, autoimmunity, orthostatic intolerance, and pediatric issues (to name a few topics). For example, Dr. Chris Snell is speaking about lessons from current treatments and clinical trials, not exercise abnormalities. If there is any discussion of cognitive dysfunction, it will only be because a speaker manages to shoehorn it into his/her talk.
How on earth can a panel of non-ME/CFS experts, presented with very limited information on the science and working over just a few days, produce recommendations for future research that will actually move the field forward? And if they manage somehow to do so, how will the recommendations be any different from what emerged from the 2011 State of the Knowledge Workshop?
I do not object to the use of non-ME/CFS experts in all cases or circumstances. I do not believe that this disease is too difficult for outsiders to understand. For example, the non-ME/CFS experts on the IOM committee have had the benefit of more than a year’s immersion in the literature with eight experts in the room to provide perspective, and this will hopefully have a positive impact on the outcome.
But for the 100% non-ME/CFS expert Panel to grasp this complex and controversial knowledge base in the very limited time they have to produce their report is an extraordinary challenge. It would be a challenge even if they were thoroughly immersed in that knowledge base through the evidence review and Workshop. As should be abundantly clear, I do not believe they will be immersed in the knowledge base. The Panel has been given a fundamentally flawed and imbalanced evidence review (compiled and written by other non-ME/CFS experts). They will hear a narrow and skewed presentation of ME/CFS science at the Workshop, despite the inclusion of some highly qualified speakers.
The P2P Panel’s report may not be our worst fears come to life, but there is a significant risk that it will not produce recommendations that will propel ME/CFS research forward – if for no other reason than the Panel will not actually be shown the full research landscape. How can you draw an accurate map if you don’t actually see your starting point or the landscape through which you must navigate? The P2P situation is a bit like asking someone to chart a path from point A to point B, but not telling them about the 4,000 foot change in altitude in between, and also not giving them the proper footwear for the hike.
Hi Jennie,
” …a significant risk that it will not produce recommendations that will propel ME/CFS research forward”
Was that ever the intention? Must admit I am not all that interested in keeping up with this: but what were the objectives of P2P? I mean the published ones. What do your government want to get out of all this? I don’t mean what do you think they want, but what have they said they want?
Many thanks.
Russ
Hi Russ,
Here is what NIH says about the goals of the P2P program: “The goal of the Pathways to Prevention (P2P) program is to host workshops that identify research gaps in a selected scientific area, identify methodological and scientific weaknesses in that scientific area, suggest research needs, and move the field forward through an unbiased, evidence-based assessment of a complex public health issue.”
https://prevention.nih.gov/programs-events/pathways-to-prevention
My favorite two-word summary of the process: “Dumbing down.”
I noticed these words in writer Clark Ellis’s interview of an ME and CFS scientist/researcher. The researcher said, in part, “These new initiatives appear to represent a further dumbing down of the research response to CFS…I believe this is revealed by the fact that non-experts are included in panels, and in P2P, panels consist entirely of non-experts. Non-experts will have different and varied priorities which are unlikely to be linked to CFS. The case definition used in P2P is too broad and does not recognise heterogeneity and subtypes…”
The P2P should be cancelled immediately. It’s a complete waste of taxpayer money.
Excellent post! I made a graphic for tweeting about this article. I’d like your permission to share on twitter and facebook. It links back to here, so I wanted to confirm it with you. Can you contact me via the e-mail I have given?
Thanks Colleen! I PMed you.
Jennie, thanks for this, especially the welcome reminder that there have been good meetings in the past that looked at our disease from a variety of angles that intercommunicate. I do find myself still disturbed by the strange structure of this process, and by the evident distrust of “experts” both in the design, and also in the AHRQ draft, which uses the phrase “expert bias” more than once. The internal mails obtained by Jeannette Burmeister also give evidence for deep suspicion within NIH of both patients and advocates. Even the top researchers were treated discourteously when they proposed using CCD henceforth.
I would have thought that the variety of expertise gathered together in most of these earlier meetings–neurologists, immunologists, systems analysts, chiropractors, geneticists, etc, might have been seen as adequate protection against unduly narrow perspectives. But there seems a pervasive distrust of people who have actually worked in the kitchen, so to speak. I still remember the CDC commenting that they had not realized how serious the disease could be. Why not? We (patients and researchers) have not been keeping it secret.
Thanks again, Chris
Thank you for this summary. It is disheartening to see the non-ME/CFS experts discussing the non-science related to our very real disease.
I just read Jeanette’s blog “Thoughts about ME.” She is combing through the documents she got from her lawsuit. She has a tongue-in-cheek approach to
the information in the documents, and bemoans the fact that taxpayers’ money
is being spent for basically a paper-pushing process with no real substance.
Everyone should take a look at it.
I’m puzzled. Why is ME being discussed at a Pathways to Prevention conference in the first place? How about we learn how to TREAT or even CURE it before we worry about who else might catch it?! We don’t need our research needs identified by a bunch of well-intentioned but ill-informed people who have no concept of this condition. How can they possibly be expected to? It was defined in 1969 by the WHO but the Canadian criteria are still under debate 45 years later! And they’re going to learn this from SCRATCH?! Seriously, I don’t know what substances the organisers of this nonsense are taking, but I’d love to try some for myself. This level of delusion cannot be naturally induced.
To the list of published reports from former very relevant meetings/conferences I would like to add this excellent document from the Invest in ME meetings in May 2014. It contains a summary from the researchers’ colloquium written by Prof Jonathan Edwards plus the abstracts from the IiMEC9 conference:
http://www.investinme.org/Documents/Education/Invest%20in%20ME%20BRMEC4%20and%20IIMEC9%20Report%202014.pdf
On page 2 the priorities identified by the researchers at the colloquium are listed:
“The dominant impression from the meeting was a consensus that although much research into ME/CFS remains exploratory there are strong leads pointing in specific directions that deserve focus of further study. The following points were highlighted as of particular relevance to future strategy.
1. A pressing need to identify clinical and biological subgroups in ME/CFS.
2. The value of further exploration of the possibility that a subgroup of ME/CFS is autoimmune, drawing on progress in other neurological and inflammatory disorders.
3. Clarification of the effector mechanisms of fatigue including central nervous, vasoactive and metabolic pathways and mediators such as cytokine or antibody.
4. Continued debate on the role of micro-organisms, with a focus on modulation of the
immune response by viruses and microbiota in particular.
5. The potential importance of mitochondrial dysfunction in linking pathogenesis to symptoms.
6. A need for better communication within the research community to make optimum use of data resources.
7. The potential value of genome analysis to identify genetic risk factors for ME/CFS”
How convenient for them to hold the P2P workshop just one week after the CFSAC. Why only one meeting anyway? If I’m following that correctly. It would be good to boycott the CFSAC. What do you think Jennie?
I think if people only have the capacity to watch one meeting, they should watch P2P and submit comments and questions through the online mechanism NIH said would be provided. As far as CFSAC, the agenda ignores the evidence review completely, and it’s not clear what the P2P discussion will be like (if any). So if people are able to, submit comment to CFSAC on the evidence review and P2P as well. It can’t hurt.
HHS has requested that public comment be directed to the ongoing work of two CFSAC sub-committees – one on centers of excellence and one on a patient registry.
https://www.blsmeetings.net/CFSAC/publicComments.cfm
Its hard to see that as anything other than purposeful redirection away from the real issues, especially when so few CFSAC recommendations ever get acted on…
For those who are going to provide comments at CFSAC, please consider focusing comments on the issues with P2P agenda and the AHRQ evidence review.
Another initiative which produced a thorough discussion of the ME/CFS research field was the OMI-MERIT meeting in 2012, where a group of high-profile, international researchers and clinicians identified the top-ten priorities within ME/CFS research:
http://openmedicineinstitute.org/research-initiatives/mecfs-merit/
There is a lot to build on for NIH, if they wanted to approach this in a constructive way – starting with their own 2011 workshop.