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.