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 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.
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.
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.