Occupy CFS

by Mary Dimmock and Jennie Spotila

The most important question about ME/CFS – the question that is the cornerstone for every aspect of ME/CFS science – is the question that the P2P Workshop will not ask:

How do ME and CFS differ? Do these illnesses lie along the same continuum of severity or are they entirely separate with common symptoms? What makes them different, what makes them the same? What is lacking in each case definition – do the non-overlapping elements of each case definition identify a subset of the illness or do they encompass the entirety of the population?

Boiled down to its essence, this set of questions is asking whether all the “ME/CFS” definitions represent the same disease or set of related diseases. The failure to ask this question puts the entire effort at risk.

This fundamental question was posed in the 2012 application for the Office of Disease Prevention to hold the P2P meeting (which I obtained through FOIA). It was posed in the 2013 contract between AHRQ and the Oregon Health & Science University for the systematic evidence review (which I obtained through FOIA). It was posed to the P2P Working Group at its January 2014 meeting to refine the questions for the evidence review and Workshop (according to Dr. Susan Maier at the January 2014 Institute of Medicine meeting).

And then the question disappeared.

The systematic evidence review protocol does not include it. Dr. Beth Collins-Sharp said at the June 2014 CFSAC meeting that the Evidence Practice Center is not considering the question because there is “not enough evidence” in the literature to answer the question. However, she said that the P2P Workshop could still consider the question.

But the draft agenda for the Workshop does not include it. Furthermore, every aspect of the P2P Workshop treats “ME/CFS” as a single disease:

• The P2P description of ME/CFS refers to it as a single disorder or illness throughout the meeting webpage.
• The P2P website characterizes the names myalgic encephalomyelitis and chronic fatigue syndrome as synonymous.
• Every section of the Workshop agenda lumps all the populations described by the multiple case definitions together, discussing prevalence, tools, subsets, outcomes, presentation, and diagnosis of this single entity.

A 20 minute presentation on “Case Definition Perspective” is the only lip service paid to this critical issue. This is completely inadequate, if for no other reason than because the presentation is isolated from discussions on the Workshop Key Questions and dependent topics like prevalence and natural history. As a result, it is unlikely to be thoroughly discussed unless one of the Panelists has a particular interest in it.

Why is this problematic? Because both the P2P Workshop and the evidence review are based on the assumption that the full set of “ME/CFS” case definitions describe the same disease. This assumption has been made without proof that it is correct and in the face of data that indicate otherwise, and therein lies the danger of failing to ask the question.

What if the case definitions do not actually describe a single disease? If there are disparate conditions like depression, deconditioning, non-specific chronic fatigue and a neuroimmune disease characterized by PEM encompassed by the full set of “ME/CFS” definitions, then lumping those together as one entity would be unscientific.

The most important part of designing scientific studies is to properly define the study subjects. One would not combine liver cancer and breast cancer patients into a single cohort to investigate cancer pathogenesis. The combination of those two groups would confound the results; such a study would be meaningful only if the two groups were separately defined and then compared to one another to identify similarities or differences. The same is true of the P2P evidence review of diagnostics and treatments: assuming that all “ME/CFS” definitions capture the same disease (or even a set of biologically related diseases) and attempting to compare studies on the combined patients will yield meaningless and confounded results if those definitions actually encompass disparate diseases.

There is a growing body of evidence that underscores the need to ask the fundamental question of whether “ME/CFS” definitions represent the same disease:

• The P2P Workshop is focused on “extreme fatigue” as the defining characteristic of “ME/CFS,” but fatigue is a common but ill-defined symptom across many diseases. Further, not all “ME/CFS” definitions require fatigue or define it in the same way. For instance, Oxford requires subjective fatigue, and specifically excludes patients with a physiological explanation for their fatigue. But the ME-ICC does not require fatigue; instead it requires PENE, which is defined to have a physiological basis.
• When FDA asked CFS and ME patients to describe their disease, we did not say “fatigue.” Patients told FDA that post-exertional malaise was the most significant symptom: “complete exhaustion, inability to get out of bed to eat, intense physical pain (including muscle soreness), incoherency, blacking out and memory loss, and flu-like symptoms.”
• Multiple studies by Jason, Brenu, Johnston and others have demonstrated significant differences in disease severity, functional impairment, levels of immunological markers and patient-reported symptoms among the different case definitions.
• Multiple studies have demonstrated that patients with PEM have impairment in energy metabolism and lowered anaerobic threshold, and have shown that patients with depression, deconditioning and a number of other chronic illnesses do not have this kind of impairment.
• Multiple studies have demonstrated differences in exercise-induced gene expression between Fukuda/CCC patients and both healthy and disease control groups.
• The wide variance in prevalence estimates shines a light on the case definition problem. Prevalence estimates for Oxford and Empirical populations are roughly six times higher than the most commonly accepted estimate for Fukuda. Even Fukuda prevalence estimates vary widely, from 0.07% to 2.6%, underscoring the non-specificity of the criteria. Nacul, et al., found that the prevalence using CCC was only 58% of the Fukuda prevalence. Vincent, et al., reported that 36% of Fukuda patients had PEM, representing a smaller population that would be eligible for diagnosis under CCC.
• The work of Dr. Jason highlights the danger of definitions that include patients with primary psychiatric illnesses, especially because such patients may respond very differently to treatments like CBT and GET.

By contrast, there have not been any published studies that demonstrate that the set of “ME/CFS” definitions being examined in P2P encompass a single entity or biologically related set of entities. From Oxford to Fukuda to ME-ICC, there are significant differences in the inclusion and exclusion criteria, including differences in the exclusion of primary psychiatric illness. The magnitude of these differences makes the lack of such proof problematic.

Given that treating all “ME/CFS” definitions as a single entity is based on an unproven assumption of the clinical equivalence of these definitions, and given that there is ample proof that these definitions do not represent the same disease or patient population, it is essential that the P2P “ME/CFS” study start by asking this question:

Does the set of “ME/CFS” definitions encompass the same disease, a spectrum of diseases, or separate, discrete conditions and diseases?

The failure to tackle this cornerstone question up-front in both the agenda and the evidence review puts the scientific validity of the entire P2P Workshop at risk. If this question is not explicitly posed, then the non-ME/CFS expert P2P Panel will swallow the assumption of a single disorder without question, if for no other reason than that they do not know the literature well enough to recognize that it is an assumption and not established fact.

Does ME/CFS kill? This critical question has received very little attention from researchers, but there is a way for you to help change that.

The first paper on causes of death in ME/CFS was published in 2006 by Dr. Leonard Jason, et. al. They looked at a registry from the National CFIDS Foundation, and compared the causes of death and ages of patients with general population data. They found that CFS patients who died of cancer, suicide and heart failure were significantly younger than people in the general population dying of the same causes. There are a number of limitations to the study, including selection bias of the cohort, but it was a very important signal that should have been investigated.

Despite calls from people like Dr. Lily Chu (read her CFSAC testimony on this subject from 2012), I’m not aware of any longitudinal or natural history studies collecting this sort of data. In 2012, Chang, et al. crunched numbers from the Medicare database and found an increased association with lymphoma, but again, there are serious limitations to that analysis.

Despite the dearth of good data, the IACFS/ME recently made the following statement in the 2014 revised Primer:

Even if patients get progressively worse, ME/CFS itself is not known to be fatal. (p. 26)

Dr. Chu offered a dissent at the recent IACFS/ME meeting, for a number of reasons. She said, in part:

We do not have evidence to say that ME is not fatal.  As far as I know, and please correct me if I am wrong, there are no longitudinal studies involving large ME/CFS populations that address this question. . . .

On the other hand, there have been cases, although rare, where death was attributed to ME. . .

The IACFS/ME is the only international scientific organization dedicated to ME/CFS. Anything we state should be evidence-based as much as possible. Statements surrounding mortality should be qualified to acknowledge the lack of and the need for more investigation.

So how do we resolve this? Two separate efforts are trying to determine just that.

At the recent IACFS/ME conference, Dr. Dana March presented data from the Chronic Fatigue Initiative’s epidemiology study. As reported on Phoenix Rising, of 960 survey respondents, 59 were determined to have died. The three highest causes of death were cancer (37.8%), heart disease (19%), and suicide (19%). That last number is pretty extraordinary, since in 2010 suicide deaths were 1.9% of deaths from all causes in the general population. Among cancer patients, suicide accounts for approximately twice that – 4% of all deaths. Granted, this is a very small sample size and the patients are drawn from ME/CFS specialty clinics. If the CFI data is confirmed in larger studies, suicide representing 19% of all deaths would be extraordinary.

One would think this would be a big enough signal to get the attention of CDC. We desperately need data on a large sample size to truly establish if people with ME/CFS have a higher risk of death from complications, from the disease process itself, or “secondary” causes like suicide (which is a primary cause to the person’s family and friends).

Natural history and longitudinal studies are expensive, in part because they need a lot of subjects and need to examine a long period of time. We will need CDC to do this work, or NIH to fund it, or NIH to fund the data platform recommended by CFSAC so that multiple researchers can do it. But we cannot and should not wait for government to get around to recognizing the need.

Enter Abby Brown (DePaul University) and Billie Moore (NJ CFS Association). Billie’s son committed suicide at age 46 after a 20 year battle with ME/CFS. Billie’s testimony on the subject is probably the most moving CFSAC public comment I’ve ever heard.

Now Billie and Abby have collaborated to create a comprehensive and detailed survey, with the goal of collecting more data in a more systematic way. The ME and CFS Mortality Study is IRB-approved and collecting responses now. If you know someone who passed away after having ME or CFS, then please consider participating in the study. The survey is very detailed, in order to collect complete details about the severity of illness and cause(s) of death. The estimated time required to complete the survey is one hour.

If you know someone who died after having ME or CFS, please participate. Feel free to share information about the study with other people you know, too. If you have any questions, you can contact Abby Brown at DePaulMECFSReseach AT gmail.com. Maybe this data will be enough to finally get the research we need.

I am very pleased to share this guest post from Darlene Prestwich in which she shares her experiences as a new(ish) advocate. I’ve been doing this so long, sometimes I forget what it was like to jump in the deep end of the advocacy pool. Darlene describes her own experiences with grace, and I am so grateful she is sharing them here today.

This week I’m home alone. My family is on an annual week-long camping trip to a neighboring state. Its incredibly painful sending them off to do things that I absolutely love to do year after year, but I don’t want ME/CFS to take those experiences away from them, too. So they stock the fridge before they leave and go adventuring without me. Last year I found it incredibly difficult to send them off. I was homebound and dealing with a particularly nasty and long-lived crash that looked as if it may be my new baseline. I had to spend much of the day in bed, being capable of self care but not much more. I was lonely, sad, and so very sick.

I could have reached out to friends, extended family, or supportive church groups, but I simply didn’t have enough energy for social interaction. That’s just one of the cruel tricks this disease plays. I decided to venture online and began to get a greater sense of the depth of the ME/CFS community there. Perhaps it was because I needed it so much right then (I’d dabbled around a bit before), but I was hooked. These people were speaking my language! Plus, I could rest mid-sentence if I needed to. Here were formerly active, capable, and successful people whose bodies and brains were so whacked out that simple physical or cognitive tasks could be overwhelming, and even lead to relapse. Many had been able to find a sense of acceptance despite the desolation of this disease and the toll it takes. Some were desperate and didn’t know if they could go on another day; they felt misunderstood, mistreated, and so very broken. It was both heartrending and encouraging and most of all, familiar.

At times going online was simply overwhelming. The combination of new terminology and technology I wasn’t very familiar with was daunting to say the least. It’s incredibly taxing to learn new things when your brain is a foggy mess. But the online advocacy community was so intriguing. Here was a group of people who were trying to rise up, be heard, and effect change. Most were doing it primarily from their beds. A few months into my forays online, HHS contracted with IOM to create a new case definition for ME/CFS. Suddenly I was signing petitions, writing letters, and urging family and friends to do the same. And all at once I went from being pleased that there was a group of people online who were speaking my language, to wondering just what language these people were speaking.

Things seemed to be in code. I’ve never been much for acronyms, and now I was swimming in them. Even Google was stumped at times. Adding to the confusion was how often simply rearranging the same letters meant something completely different: i.e. IOM,OMI, & IMO (or its perhaps more gracious variation, IMHO). Many a browsing session turned into an IAMGOTOBED experience. (Internet Acronym Mess Got Overwhelming, Tired Out Brain Ends Day)

Without advocates who were willing to educate me I would have been completely lost. There are many patient, inclusive, and kind people in this community. It takes work to bring someone up to speed, and it’s a steep learning curve for an absolute beginner. I am very appreciative of those who were—and continue to be—willing to use precious energy to answer my sometimes incredibly basic questions. The more I learn about the history of ME/CFS, the more my admiration grows for those who have been advocating tirelessly for years. (Well, maybe not tirelessly, but in spite of being profoundly tired.) There are also many who have worn themselves out trying to be heard.

These were people with strong opinions who felt passionate about their cause, but who didn’t always agree. The IOM contract was hugely divisive, and it was disconcerting to see how viciously some advocates attacked other advocates. It seemed so counterproductive, especially within a movement which faces the unique challenges this one does. It has been said that advocacy is a messy business and those who want to contribute should put on their “big girl pants” and grow a thicker skin. I’m sure that can be helpful advice, but it seems doubly challenging for people who are often so ill they rarely even put on pants. On the other hand, I’ve watched advocates who were sharply divided quickly leap to other’s defense when attacks came from without the community. I got the sense that this community feels sort of like a family.

I was enjoying this business of being an advocate. I was getting a better grasp of the technology, and with repeated use the terminology wasn’t so intimidating either. Then I ran across an opinion that gave me pause. Someone had posted that there were too many people claiming the title of advocate. They suggested that signing petitions and writing letters Does Not an Advocate Make. Well, I’m not a lobbyist or a lawyer, and I haven’t started a patient organization. I don’t run a support group or make films. I don’t even have a blog. So… maybe I’m just some sort of a wannabe advocate. I suppose the answer lies in how one defines ‘advocate’. I do know that I am advocating. And at times it comes at a substantial personal cost; it doesn’t take much to do that, unfortunately. But it feels good to be doing something; and for now I suppose that will have to be enough.

Through all this I’ve become more open about my illness with my friends and extended family. I’ve appealed to government representatives and become more willing to attempt to educate my various healthcare providers. After all, it takes courage simply to admit I have an illness as lame as Chronic Fatigue Syndrome sounds. And although Myalgic Encephalomyelitis now trips easily off my tongue, even my closest family has yet to master that mouthful consistently. I also feel a much greater responsibility to fight for others who are suffering, as well as those who will be stricken down by this devastating disease.

So this week will be quiet, and a bit lonely. But I’m pleased that I have new friends and acquaintances that I didn’t have last year. Many are, without a doubt, Completely Legitimate Advocates. I still have so much to learn, and not nearly enough capacity to do everything I would like. But I’ve come to believe that my voice is important. After all, imo we need every voice we can get.

I feel like a broken record, saying that the June 16-17th CFS Advisory Committee meeting was frustrating. This meeting struck me as a tangle of threads that can only be understood by teasing them apart. There were signals buried in the discussion that should raise concern in the advocacy community. Rather than summarize the content of the entire meeting, I would like to parse some of the issues with you.
 

Toothless Recommendations

 
Watching group wordsmithing is always incredibly painful. I know many patients got frustrated during the Committee’s discussions of their recommendations. Despite the fact that Dr. Dane Cook’s group presented a comprehensive summary of the Researcher Recruitment Working Group rationale and well-drafted recommendations, the conversation still went off the rails a few times. Rather than recap the whole thing, I’ll just focus on the recommendations themselves.

The first recommendation was for NIH to fund and support a data platform for biobank and clinical data. The idea is based on the NDAR platform, and Dan Hall gave a great presentation on NDAR but not until after the CFSAC had already passed the recommendation. As a result of this backwards agenda, the CFSAC failed to discuss or include a very important element: funding.

Dan Hall estimated that cloning NDAR for ME/CFS would cost about $1 million, and then somewhat less to maintain annually thereafter. The CFSAC recommendation does not include the price tag for the data platform, and no one discussed the feasibility of requesting this kind of funding. Remember that $1 million is 20% of NIH’s annual spending on ME/CFS research. How likely is it that NIH will spend this kind of money on a data platform for us? I strongly support the recommendation, as a data platform like this is desperately needed and none of the non-profits have the resources to make it a reality. But even with the background support document drafted by Dr. Cook’s Working Group, it seems optimistic to believe that NIH will approve this in the short term.

The second recommendation for an RFA was very controversial, and discussed on both days. The original proposal was that the Trans-NIH ME/CFS Working Group, led by Dr. Mariela Shirley, would recommend the content of an RFA based on the P2P Workshop and the 2011 State of the Knowledge meeting. CFSAC member were appropriately concerned about voting for an RFA based on a document that won’t be written for many months. There was extensive argument, but a motion to remove the reference to P2P failed. Chris Williams (Solve ME/CFS Initiative) pointed out that the recommendation would be “toothless” without a dollar figure, but that was ignored.

There was also great controversy over whether to include a deadline for the RFA. A minority of the CFSAC members felt that including a date would kill the entire recommendation. One suggested deadline was December 31, 2015, but Dr. Alisa Koch (new CFSAC member) pointed out that this would mean grants would not even be reviewed until 2016, let alone funded. Eventually, the CFSAC amended the recommendation to state a deadline of “November 1, 2014, or as soon as feasible.” I agree wholeheartedly with the CFSAC members who pointed out that the “as soon as feasible” would be used by NIH to delay the RFA until whenever it sees fit.

Finally, the CFSAC voted to establish two new working groups. The first, suggested by Dr. Jose Montoya (new CFSAC member) will develop a case for Centers of Excellence. This is a long standing and much repeated recommendation of CFSAC, and developing the case for it will be fantastic.

The second working group, suggested by Dr. Gary Kaplan, will examine ways to interface with Patients Like Me and push that out to the community. I was really surprised by this. While the presentation by Patients Like Me was impressive, Ben Heywood admitted that PLM has not invested any effort in building out the ME/CFS community there. There are multiple problems with the way ME/CFS is defined and measured on PLM. And not a single person raised the issue that PLM is a for-profit company. They aggregate and sell their data. I don’t see how the federal government (directly or through CFSAC) can undertake a project that will specifically benefit a single for-profit company.

The worrying signal here is the Committee’s failure to make its recommendations based on a full assessment of all the facts and a view of the overall landscape. Dr. Cook’s Working Group presented the best prepared recommendations we’ve seen in quite some time, but the failure to include target numbers and meaningful deadlines continues to be a problem.
 

Compromising to Get Along

 
The most disturbing thing about the meeting was the conflicting approaches of the CFSAC members. This was most on display during discussion of P2P and the RFA recommendation.

Dr. Cook explained that the reason the RFA recommendation included a reference to P2P was because the group believed NIH would wait for the P2P regardless of what CFSAC said. Therefore, the recommendation should just accept P2P as a done deal in order to avoid antagonizing NIH. Dr. Cook and Dr. Casillas, backed up by Dr. Nancy Lee, said the recommendation would fail otherwise. NIH has apparently sent a letter to IACFS/ME responding to their RFA request, and Drs. Friedberg, Cook and Lee all said that the letter states NIH will wait for the P2P before issuing an RFA (I haven’t seen this letter).

This conciliatory view was expressed most frequently by Dr. Gary Kaplan and Dr. Fred Friedberg (IACFS/ME). I copied down multiple statements from both. Dr. Kaplan said that CFSAC should be “more aligned” with NIH, making a “polite suggestion.” He said CFSAC should “be collegial so they’ll want to work with us.” He also said we have “nothing to fear” from P2P.

Dr. Friedberg was more emphatic. He said that the recommendation should not exclude something just because we might not like it, and that he doesn’t like us vs. them thinking. He said that the recommendation should “eliminate implicit antagonism,” and, “I don’t like the demand quality.” Regarding the prospect that CFSAC (or advocates) may not like some or all of the IOM and/or P2P recommendations, he said we should “make lemonade” rather than engage in  “wholesale condemnation.”

The opposing view was expressed by Steve Krafchick, who said Dr. Kaplan’s collegial approach was “naive.” Dr. Mary Ann Fletcher specifically responded to Dr. Kaplan’s comment as well, saying that the CFSAC charter doesn’t say anything about getting along with NIH. She said that the Committee’s job was to advise the Secretary as experts in the field, and they they were not being fair to patients by putting things off to be collegial.

There was an inherent contradiction in the research recommendations, too. The recommendation on the data platform was passed with no discussion of cost or likelihood of success. There is a need for a data platform, so the Committee recommended it – and that is as it should be. But for the RFA, the majority felt that P2P should be accepted as part of the process simply because that is how NIH appears to be doing business, regardless of the fact that everyone agreed that RFA funding was needed now.

The worrying signal here was identified by Mary Dimmock (from the audience). She pointed out that it was a dangerous precedent to put forward recommendations that seemed likely to succeed, as opposed to the best recommendations that are most needed. I could not agree more. CFSAC’s job is to give the Secretary the best advice, not the advice that the Secretary or the agencies want to hear.
 

Moving forward . . . . together?

 
The last session of the meeting was facilitated by Deputy Assistant Secretary Anand Parekh. I was fascinated by the move to bring him in to lead this discussion. Was this a tacit recognition that Dr. Nancy Lee has had difficulty facilitating discussion about IOM, like the awkward session at the December 2013 CFSAC meeting? The other new development was an actual open forum. In the past, “open” discussion with the audience has been limited to the Chairman selecting questions that have been written on index cards. In this case, members of the audience were handed a microphone and they could address the Committee directly. I wish this had been more widely publicized (a simple email on the CFSAC listserv would have sufficed). I am probably not the only person who would have risked the health consequences to attend for that opportunity. Several prominent advocates had left the meeting by then, as well.

Margaret Jacobs from the American Epilepsy Association presented on the epilepsy community’s experiences with their own IOM report and subsequent cooperation with HHS. Because a number of epilepsy organizations helped fund that IOM study, they had input into the statement of work, received monthly status calls, and received the recommendations a week before public release so they could prepare their messaging. The cooperation before and during the IOM process laid a strong foundation for continued cooperation afterwards, with the epilepsy community and HHS working together.

The same is true for our situation: what happened before the IOM study is setting the stage for what will come after. HHS pursued the IOM study in secret without involving the stakeholders outside the federal government. The ME/CFS advocacy community found out about the contract by accident, and when we protested, HHS simply changed the contract mechanism to one that did not require public notice. There was no collaboration, no engagement, and communications were terrible.

Now HHS seems to think we can all come to the table and work together. I am deeply troubled by the fact that the government holds all the cards here. They will have about a week to prepare messaging on the IOM report, while we will have no opportunity to do so. The P2P report is issued pretty quickly after the meeting, but NIH will be in control of the press conference push behind the report. This simply isn’t creating a dynamic where the stakeholders can actually collaborate. I’m not sure if it will be possible, and the content of the IOM/P2P reports is only one factor in the way.

The worrying signal here is the open question of whether HHS actually wants to change the paradigm and is willing to do the work necessary. Dr. Lee said they “don’t want to do this without [community] involvement,” but if she means the kind of involvement we have had to date, then there is nothing to really talk about. It is going to take a great deal of work on both sides to change the trajectory here.

Dr. Parekh said twice that “there is a lot of angst among patient groups about IOM.” It’s not angst. We have legitimate scientific and policy concerns. Angst is easily dismissed as unreasonable anxiety. I do not know if HHS understands and appreciates the difference.

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.

Andrew Bokelman was scheduled to deliver public comment to the CFS Advisory Committee on June 17th and was the first telephone commenter. His call was terminated by the operator prior to his 3 minutes being up. After protest on Andrew’s behalf from CFSAC members, Marty Bond apologized to Andrew and he was given an additional minute to speak (which he discovered only because he accidentally had not terminated the call). We also learned that written comments from the public were not provided to CFSAC members as per usual. Andrew gave me permission to publish his comments in full.

Hello. My name is Andrew Bokelman.

The HHS told us they welcome outside research about ME/CFS, but we should make sure it is evidence-based. This makes sense to me. And so now I call on the HHS to do the same. To make sure your information is evidence-based. I also ask that the HHS commit to being evidence-based, even if you have to retract something you said before, or remove it, or stop it.

And this brings me to the IOM contract. I looked at the IOM’s past work with CFS. It is not evidence-based, even when this is required. An example is the gulf War Syndrome treatment guide, which contains a section for treating Chronic Fatigue Syndrome. The section recommends exercise, and to support this they reference a journal article that doesn’t mention CFS. They reference an institutional web-based guide that cites no evidence. They reference the 1994 Case Definition, which says nothing about exercise. So at best, the IOM is speculating while looking at secondary resources. This is not evidence-based research.

I invite you to look at the hard copy of my testimony. I documented the few examples I gave. Spot check these to confirm what I said. Then contact me and I’ll demonstrate that the rest of the treatment section does not consist of sound evidence-based research.

Or maybe you think what I say cannot be true, so no need to check. After all, the IOM is a high-profile research center that uses hand-selected panels whose work is reviewed by a separate review board. But look more closely. The review board cannot compel the primary panel to correct their choices. It can only suggest they do. Nor can they review the final draft. I confirmed this with IOM staff. They defend their laissez-faire method of quality-control by saying it preserves the independence of the panel. But the proof is in the product. And their product is not evidence-based.

Now, you could just ignore what I say and hope this won’t be one more IOM disaster. But keep in mind, there is no way to undo this, once it is complete. So I call on the CFSAC and the HHS representatives here to do the right thing. Check my hard copy to see if what I said is true. And then follow up with me. Please don’t dismiss my involvement because I’m a member of the public. I worked as an analyst for 20 years, and I am the one person who can articulate my reasons for believing the rest is not sound evidence-based research. The IOM is really not qualified to handle this project, and government regulations provide a way to terminate the contract.

Thank you for letting me speak.

References:

1. Gulf War and Health: Treatment for Chronic Multisymptom Illness By Board on the Health of Select Populations, Committee on Gulf War and Health: Treatment for Chronic Multisymptom Illness, Institute of Medicine.

You can obtain a free pdf version at this site: http://www.nap.edu/catalog.php?record_id=18253. All you have to do is register, and then you will have access to the PDF version. The CFS treatment guide begins on page 99.

2. Harber, V. J., and J. R. Sutton. 1984. Endorphins and exercise. Sports Medicine 1(2):154-171. http://www.ncbi.nlm.nih.gov/pubmed/6091217 (accessed November 11, 2012).

This is the journal article that doesn’t mention CFS. It did not report research on CFS. At best, the IOM is speculating, not presenting evidence.

3. CDC. Undated. Chronic Fatigue Syndrome: A Tool Kit for Providers. http://www.cdc.gov/cfs/pdf/cfs-toolkit.pdf (accessed November 13, 2012).

This is a web resource that contains no evidence. It is not a primary resource. And it is also the same Tool Kit that the CFSAC recommended be removed from the CDC website (see the recommendation here: http://www.hhs.gov/advcomcfs/recommendations/06132012.html).

4. CDC (Centers for Disease Control and Prevention). 1994. Chronic Fatigue Syndrome: The 1994 Case Definition. http://www.cdc.gov/cfs/case-definition/1994.html (accessed November 13, 2012).

This the 1994 definition of Chronic Fatigue Syndrome. The 1994 criteria (and the web page they are on) says nothing about exercise, one way or the other.

Charmian delivered these comments at today’s CFS Advisory Committee meeting. She has kindly given me permission to publish them here in their entirety.

My name is Charmian Proskauer, and I currently serve as President of the Massachusetts CFIDS/ME & FM Association.  However I am testifying as an individual, not as a representative of the Association.

As has been previously pointed out, in October 2012 “CFSAC recommends that you will promptly convene (by 12/31/12 or as soon as possible thereafter) at least one stakeholders’ (Myalgic Encephalomyelitis (ME)/Chronic Fatigue Syndrome (CFS)experts, patients, advocates) workshop  in consultation with CFSAC members to reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS beginning with the 2003 Canadian Consensus  Definition for discussion purposes.”

This recommendation appears to have morphed into two separate initiatives, both begun by a government agency without any consultation or input from this Committee or from the patient community – the Institute of Medicine Diagnostic Criteria for ME/CFS activity and NIH’s Pathways to Prevention, or P2P. I would like to talk about both of these.

First, IOM.  Although hundreds, if not several thousands, of ME/CFS patients along with over 50 expert ME/CFS researchers and clinicians, called for the IOM contract to be cancelled, it was not, and the process is going ahead.  However, the IOM process has been open to public input from the beginning, and the committee itself has a healthy representation of acknowledged ME/CFS experts, including some who signed the letter urging the contract to be cancelled.  These experts, as I understand, have the task of reviewing relevant research and clinical literature, and because of their expertise, they can bring to the committee the judgment to separate the good studies from the bad, and the clinical experience to understand the role of various types of treatments that are applied to this illness.  Also the goals that were established in the beginning are still the goals, and they are important ones of recommending a definition of the illness that can be used for making a clinical diagnosis, and developing a plan for education of health care professionals across the board on awareness and diagnosis of the illness.  While patients and advocates are still very concerned about what will be in the final report of this committee, at least there is recognized expertise on the committee and public input in the process.

The same cannot be said for P2P.  This appears to be a closed process within NIH, which over many years has given little serious attention to this very serious illness.  By design, NO members of the panel have any expertise regarding ME/CFS.  The literature review has been contracted out to an outside group, again with no expertise in understanding the context of the ME/CFS literature, good and bad. This outside group is then tasked to prepare a summary report, which will be given to the non-experts on the panel for them to use in their deliberations.  Furthermore, while the original goals of NIH to “conduct an evidence‐based review of the status of ME/CFS research and also convene a dedicated workshop to address the research case definition for ME/CFS” and to create research recommendations made sense, this has since morphed into a different goal which appears to focus on treating “overwhelming fatigue” as a public health problem, and with the treatments of CBT and Graded Exercise Therapy leading the list of treatments!  And this BOGUS process, which by its very setup is not likely to come to any legitimate conclusions about the real disease characterized by Post-Exertional Malaise and Cognitive Dysfunction along with many other physical symptoms, is what will presumably guide NIH in allocating research money (or NOT) for ME/CFS in the foreseeable future!

I therefore urge that the P2P process be suspended, at least until the IOM process has issued its final report and can be taken into account in P2P deliberations, and P2P can address its original goals of creating a research definition for the illness and then addressing research gaps.

Thank you.

These are the comments I delivered by telephone to the CFS Advisory Committee today. For the record, the operator told me that they were instructed to cut people off precisely at 3 minutes.

Mary Dimmock and I wrote to Dr. Collins about a number of scientific and policy concerns regarding the P2P Workshop, and I ask that NIH and this Committee give these concerns a fair hearing. It doesn’t matter that the P2P process is the same for every disease. The issue is that P2P is not right for THIS disease, for many reasons, not just the makeup of the Panel. These multiple issues are documented in the letter provided to you yesterday, and I think that we deserve the respect of having those concerns considered and addressed.

The danger posed by this fundamentally flawed P2P process is underscored by your discussion about whether an RFA should draw upon the P2P report. I understand the practicality of wanting to align your recommendation with what NIH is doing, and I recognize the tremendous work presented by Dr. Cook yesterday. But we already know that there are flaws and deficiencies in the entire P2P approach, so basing the RFA even partially upon such marred recommendations is risky, to say the least.

The P2P Panel’s primary source of information will be the systematic evidence review. I am not the only one with concerns about this. Last week, the Solve ME/CFS Initiative told NIH that the review search strategy is likely to result in a “grave and substantial error.” Yet this report will shape the non-ME/CFS expert Panel’s knowledge about the disease. ME/CFS expert input will be constrained to less than two days at the Workshop meeting. It is the non-expert Panel that has the power to make decisions, writing their recommendations in 24 hours after the Workshop meeting.

Your recommendation paves the way for an RFA based on the output of that process. You must recognize that by accepting P2P, you have told NIH that you will also accept an RFA based on recommendations written by a group of people with no expert knowledge of ME/CFS and whose primary source of information is a systematic review laden with grave and substantial errors.

My approach to advocacy is moderate, and I don’t like us vs. them thinking, but in this instance I must stand up and say this is scientifically and politically wrong. P2P as it is unfolding for ME/CFS incorporates multiple significant problems. We cannot afford to cross our fingers and hope the P2P output is good, when we already know it is going wrong. As many of you said yesterday, the 2011 State of the Knowledge meeting identified the gaps in research. NIH has what it needs to issue an RFA now. That is what should happen, and NIH should meaningfully engage with all the ME/CFS stakeholders to find the right path forward.

Joe Landson delivered these comments at the CFS Advisory Committee meeting today. He has kindly given me permission to post them in their entirety here.

Testimony of Joseph D. Landson

June 2014 Chronic Fatigue Syndrome Advisory Committee

First, credit where credit is due. Thanks to the Social Security Administration (SSA) for its recent revision of ME/CFS disability guidelines. Thanks to the Food and Drug Administration (FDA) for its efforts to ease the approval path for prospective ME/CFS treatments.

So much for the good news; now for the bad. The contradiction in the Pathways to Prevention (P2P) program is so perverted, that only Donald Rumsfeld could appreciate it.

Let me explain. Back in September 2012, a group of patients met with a National Institutes of Health (NIH) official named Dr. Michael Gottesman. Patients asked him why ME/CFS had been largely ignored for over two decades.  Dr. Gottesman replied this was due to a lack of concrete scientific, clinical, medical findings and published papers. In other words, no evidence, no support. The thousands of published journal articles apparently didn’t interest him.

Flash forward to today. Recently, the Agency for Healthcare Research and Quality (AHRQ) revealed the evidence review plan for the NIH’s P2P process for ME/CFS.

But any evidence review begs the question: What evidence is the P2P process reviewing? Is it reviewing the evidence that Dr. Gottesman implied doesn’t exist? In that case Dr. Gottesman seems to have spoken in error. Or, is Dr. Gottesman correct, and there really is no evidence to review? In that case, what on Earth is P2P doing?

If I could ask Donald Rumsfeld, maybe he’d say the purpose of P2P is to find an absence of evidence, a rationale to continue ignoring us. Since we mere patients are almost completely locked out of P2P, who’s to say? We can say what we do see: evidence of absence.

There is an absence of any serious attempt to frame ME/CFS as the systemic biological illness that we experience it to be. There is an absence of any effort to re-imagine a so-called empirical approach in government research, an approach that has demonstrably failed even to measure the illness reliably, let alone do anything to treat it. In P2P, there is an absence of any serious attempt to engage patients in a desperately needed rethinking of the research approach to this illness.

I urge that P2P either be opened up, or discontinued.

Listen carefully to the agency updates at the June 16th CFS Advisory Committee meeting. Updates on the P2P Workshop and systematic evidence review may sound reasonable, but I suspect that hidden within will be some spin-doctoring to deflect our concerns about (and criticisms of) the P2P Workshop. So let’s just get it out of the way right now. Here are some possible spin arguments, and my responses.

The P2P Workshop is responsive to the CFS Advisory Committee recommendation to hold a meeting on case definition.

No, it is not. The recommendation was for a meeting to devise a clinical and research case definition. NIH has said that the P2P Workshop is expressly NOT devising a case definition.

ME/CFS experts are participating in every phase of the P2P Workshop.

Every phase except the one that really matters, and the expert participation is marginal. For example, there are twenty people on the P2P Working Group (that met in January to plan the meeting), but only five of them are ME/CFS experts. The full Working Group only meets once, if it follows the pattern of other P2P meetings. We don’t know how many experts are on the Technical Expert Panel (which helped with the protocol for the evidence review). The experts who will speak at the Workshop? Yeah, we don’t know who they are either. And the group that really matters is the P2P Panel and by design, NO experts whatsoever will be on that Panel. Ask yourself: would you have accepted an IOM committee with no ME/CFS experts on it? Then why is it ok for P2P?

Don’t worry, the P2P Panel of non-ME/CFS experts is just like a jury.

No, actually, it is nothing like a jury. For one thing, juries are selected in public, with both sides of a case having the opportunity to question potential jurors and move for their disqualification. The P2P Panel? Selected by NIH, behind closed doors, with no transparency for how they are screened for bias or preconceptions about ME/CFS. That’s like letting the prosecution choose a jury before anyone walks into the courtroom. Furthermore, this “jury” will make decisions based on an evidence base and field that is controversial, confusing, and laden with bias. No jury would ever be cast adrift in such murky waters without multiple layers of guidance and experts to assist them.

The systematic evidence review is the best methodology out there.

This may be true, although there is certainly controversy over the value of evidence reviews. But the issue is not the methodology. The issue is the study protocol that will be used to apply that methodology.  I’ve already documented the multiple concerns with the protocol, beginning with the failure to ask if the case definitions capture more than one disease. Beyond that, remember that the evidence review is the PRIMARY source of information for the Panel of non-ME/CFS experts. If the review doesn’t ask the right questions, then there is little chance that the Panel will do so at the Workshop.

The P2P Workshop will cover more than the Key Questions as stated in the evidence review protocol.

I’m hearing this already from several sources, and I have three objections. First, the draft agenda documents follow the evidence review questions very closely. And if you compare the key questions and agenda for the P2P Opioid meeting, you will see that they match. Second, even if it is true that the Workshop will cover additional questions – where are those questions? Why is there no transparency about the content of the Workshop? If there are additional topics being covered, then NIH should release that information immediately. Third, if the evidence review does not include some of the questions, then how can the Workshop adequately cover those questions in the absence of the evidence report?

The Workshop will cover ME/CFS, not medically unexplained fatigue.

Then why is the evidence review covering studies on patients with fatigue and no underlying diagnosis? Why does the draft meeting agenda describe the overview section as “Overwhelming fatigue and malaise as a public health problem”?

Our experts and the public will be able to refute anything that goes wrong in the systematic evidence report.

The calendar matters here. The evidence review, conducted and written by a contractor with no ME/CFS expertise, will be published in draft form six weeks prior to the Workshop. At the same time, the contractor will present the evidence review to the P2P Panel (also with no ME/CFS expertise) in a three hour closed door meeting. The two groups of non-experts will discuss the evidence report. Not a single expert will be in the room to point out anything that went wrong with the review. So technically, yes, the public can comment on the draft evidence report. But in reality? The non-expert Panel may never see those comments and even if they do, they will assess the comments after spending three hours discussing the non-expert report with other non-experts.

Our experts will be able to provide all the necessary information at the Workshop meeting.

The speakers may have been suggested by the Working Group (only 25% of whom were ME/CFS experts), but the final agenda and speakers are selected by NIH. Each speaker has 20 minutes to talk about their assigned topic. There is time for discussion on the agenda, but we don’t know how it will work. Will the non-expert Panel control discussion with questions? Will there be an open mike that gives experts and patients an opportunity to point out everything that is wrong with the evidence report? We don’t know. Remember, the non-expert Panel takes the evidence report (which they review for 6 weeks) and the Workshop (which lasts 1.5 days and is controlled by NIH), and then they have to turn all that information around and in 24 hours produce a report with recommendations on the future directions of research, case definition, and possibly treatments.

To put this challenge in context, remember the 2011 State of the Knowledge meeting? That was a two day meeting and all the presenters were ME/CFS experts. The summary of research gaps and opportunities was presented by Dr. Suzanne Vernon with the Director of NIH, Dr. Francis Collins, in the room. And what has happened at NIH for ME/CFS research since then? An RFA? Nope. A strategic plan? Nope. Engagement with stakeholders, increase in funding, fair grant review? If a two day meeting of ME/CFS experts that provided input directly to the Director of NIH could not fix any of these problems, then a panel of non-ME/CFS experts using a flawed evidence review and 1.5 days of presentations of experts and non-experts combined will be facing a very steep climb to deliver a strong set of recommendations after 24 hours of discussion.

We should be glad NIH is paying this much attention to ME/CFS.

So any attention is good attention? No. In this case, attention in the form of bad key questions and the framing of the problem as “overwhelming fatigue or malaise” could be very damaging and counter-productive. The conclusions and report of the Panel of non-ME/CFS experts will shape NIH policy. NIH will put a media relations push behind the report. We will be stuck with it for some time to come.

Opposition to P2P is just nay saying and complaining.

As I’ve extensively documented here and in the letter to Dr. Collins, there are legitimate concerns that this process will not produce recommendations that move the field forward with the best of what science can offer. To dismiss these concerns as complaints or negativity is, quite frankly, disrespectful of the advocates who have taken the time to express them. Give my concerns a fair hearing. Then let’s talk about whether the P2P Workshop is the best way to collaborate with the ME/CFS research and clinical community. Anyone who thinks we’re whining or overreacting has not actually read the material submitted to Dr. Collins.

Don’t worry. We’re NIH and we know what we’re doing.

Even the most qualified scientist can get it wrong. Even the purest motivations can lead to mistakes. I’ve written before about the problems of mistrust and disrespect in the ME/CFS landscape. NIH should not tell us to just trust them. NIH should be demonstrating that it is safe and appropriate for us to trust them. Based on what I’ve documented about P2P thus far, they have not done so.