P2P Agenda Fatigue

Posted on May 22, 2014 by Jennie Spotila

everyday+tiredness+may+progress+to+serious+health+problems_16000193_800453098_0_0_7077591_300HHS officials have made confusing statements about the goals of the P2P Workshop, but I have obtained documents through FOIA that give us insight into the structure of the meeting. Two versions of the Workshop draft agenda strongly suggest that the meeting will be focused on the broad category of unexplained fatigue, and the most effective treatments for that symptom.
 

The Agenda Documents

 
I obtained these two agenda documents from NIH through a FOIA request. The first is titled “DRAFT Agenda” (previously obtained by another advocate, as well) and the second is titled “Agenda Example.” Neither document is dated, but circumstantial evidence suggests that both were drafted after the January 2014 Working Group meeting.

The Draft includes a list of possible speakers, including several advocates to address the “Patient Perspective.” My name is on that list, but I have not been contacted by anyone at NIH at any time about serving in that capacity. I don’t even know who put my name forward. Whether an invitation will be extended to me remains to be seen.

The Key Questions as presented in the Draft and Example documents are likely out of date, now that the systematic review protocol has been published. The Questions from the evidence review will structure the meeting, but the agendas are important indicators of NIH’s perspective and overall approach to the meeting.
 

Framing With Fatigue

 
Both of the documents include the same description of the overview that will begin the meeting:

Dr. Maier will detail the topic and why it is of public health importance:

Overwhelming fatigue or malaise as a public health problem
Controversies that exist
Treating ME/CFS with drug and non-drug therapies

Just to be sure you didn’t miss it, here’s is the framing for this meeting on ME/CFS: Overwhelming fatigue or malaise as a public health problem. Not ME/CFS as a public health problem. Not post-exertional malaise as a public health problem. Not cognitive dysfunction and disability as a public health problem. To NIH, “overwhelming fatigue” is the public health problem.

This is so wrong. It ignores what we’ve been saying about our experiences for years. It ignores the science on PEM and cognitive dysfunction. It ignores the fundamental question of what disease or diseases are being included in the CFS bucket. In fact, it steps back in time to the Oxford definition: overwhelming fatigue alone.

The real public health problem is that since 1988, CFS has been a wastebasket and dumping ground for people with unexplained chronic fatigue. Some of those people have depression, anxiety, MS, and other illnesses. Some of those people have medically unexplained fatigue. Some of those people have a disease characterized by PEM and cognitive dysfunction.

To lump all of that together as a public health problem of “overwhelming fatigue” completely and utterly misses the point. It perpetuates the hand waving and blurred lines in the government’s approach to my disease, and there’s just no excuse for it at this point.
 

Treatment Barges In

 
At the May 2013 CFSAC meeting, Dr. Maier said that treatment research was part of the evidence review, but she portrayed it as relating back to the case definition question:

The goal of the evidence-based methodology workshop is to understand and identify how the evidence shows up for case definitions, for outcomes, for interventions, and for treatments. If it turns out that some interventions have more impact or a more positive outcome for post-exertional malaise, then we’re going to know that post- exertional malaise in a case definition is probably going to be a good thing to do. Dr. Maier, May 23, 2013 CFSAC Minutes, p. 11. (emphasis added)

But now we know that the evidence review will ask about treatment harms and benefits, and the characteristics of subgroups, responders and non-responders. The agenda documents reveal what this treatment focus will look like.

The Draft Agenda focuses on tools to measure outcomes, rather than comparative effectiveness of treatments. The Agenda Example document is very different. Here are the treatment presentations from that document (each topic allocated 20 minutes):

Cognitive Behavioral Therapy
Graded Exercise Programs
Symptom-based Medication Management
Harms
Patient-Centered Outcomes
Quality of Life

So we have an evidence review that lumps all the case definitions together, including Oxford. And we have an agenda that gives more time to CBT and GET than it does to symptom-based medication. And there is nothing here on disease-modifying treatment, like rituximab, Ampligen, or antivirals.

The topic selection and allocation of time among these treatment topics sends a subtle but powerful message to the Panel of non-ME/CFS experts, especially in light of the failure to distinguish among the case definitions at the outset. Previous evidence reviews, including AHRQ’s review from 2001 and the Brurberg, et al review published in February found no significant differences among case definitions or treatment outcomes, but those reviews were not set up to critically examine those differences. And as I’ve already pointed out, this current review assumes that differences among definitions represent subtypes and not separate diseases.
 

Design Flaws

 
The agenda documents show that the P2P Workshop is fundamentally flawed. The meeting is framed with the public health problem of “overwhelming fatigue.” The evidence review will include studies on adults with fatigue, and exclude those with unspecified underlying diagnoses. All the case definitions are lumped together for the purposes of assessing the reliability of those definitions and the effectiveness of treatments.

The evidence review and meeting agenda should begin with the proper scientific question: are ME and CFS the same disease, separate diseases, or points along a spectrum of fatiguing illnesses? That was the original starting question in the AHRQ evidence review contract, by the way. But it’s gone. The decision was made (not sure by whom) to assume the answer: that it is all one disease, separated only by subgroups. That assumption is the fatal flaw in this entire enterprise.

Remember that the P2P outcome will be decided by a panel of non-ME/CFS experts. We don’t know how they will be screened for bias. We won’t know who they are until shortly before the meeting. We will have no input into their selection.

This is not good science. This is sloppy, not precise. To revisit Dr. Maier’s jury analogy: this process will ask the allegedly impartial jury (selected by only one side) to reach conclusions based on evidence that has been marred by bias and assumptions. Maybe they will reach the right conclusions, or maybe the deck is stacked against us.

We have to find ways to speak out about this. I’m working on something right now, and there will be ways for you to express your own concerns.  I hope you will join me.

 

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Will the Real P2P Please Stand Up?

Posted on May 19, 2014 by Jennie Spotila

standingoutWhat is the purpose of the ME/CFS P2P meeting at NIH? You would think that we would know by now, since Assistant Secretary Dr. Howard Koh first announced the effort in October 2012. But to say the rhetoric has evolved over time would be a kind description.

HHS keeps changing the answers to questions about the purpose of the workshop, what kind of research is on the table, and whether the ME/CFS experts have meaningful input.

To me, it looks more like a bait and switch where the meeting sounded better the further back in time you look, and key information (like the panel being 100% non-experts) was withheld until the very last minute. The reality of this meeting is very different from the picture they portrayed early on.
 

Are we making a research case definition or not?

 
First they told us the workshop would create a new case definition:
 

The NIH has made a commitment 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. Dr. Howard Koh, October 3, 2012 CFSAC Minutes, p. 5.

To address the highest priority identified, which was “case definition issues,” the Working Group submitted a competitive application for an Evidence-based Methodology Workshop (EbMW) on ME/CFS coordinated by the NIH Office of Disease Prevention. May 1, 2013, Response from Dr. Howard Koh to CFS Advisory Committee, p. 3

 
Then they told us it wouldn’t:
 

The purpose of the Pathways to Prevention Program and the ME/CFS workshop is not —and I repeat, not—to create a new case definition for research for ME/CFS. Dr. Susan Maier, December 11, 2013 CFSAC Minutes, p. 16.

 
But in the middle, they said the meeting might help with a research case definition:
 

This will not create a research case definition in the end, but will inform anyone who wants to do research in this area about what aspects of the case definition are really strong, which are really lacking, and how those holes might be filled. Dr. Beth Collins-Sharp, May 23, 2013 CFSAC Minutes, P. 16.

 

But the meeting is about research, right?

 
The answer might depend on the day, and the person you ask. Here are the research-oriented answers:
 

The purpose of an evidence-based methodology workshop is to identify methodological and scientific weaknesses in a scientific area and move the field forward through the unbiased and evidence-based assessment of a very complex clinical issue. Dr. Susan Maier, May 23, 2013 CFSAC Minutes, p. 6.

The takeaways from a systematic review are answers to the key questions that identify where there’s strong evidence, where there are gaps, and some ideas about how those gaps may be filled. Those are called research recommendations. Dr. Beth Collins-Sharp, May 23, 2013 CFSAC Minutes, p. 13.

It has the potential to be both [research and clinical], but understanding that we are a research organization and our focus is to improve the, um, the integrity of the science that is used for translation into clinical care means that we have to focus on besting the science that is used for the evidence. Dr. Susan Maier, Institute of Medicine Public Meeting, January 27, 2014, Minute 0:19.

 
Bob Miller, who served on the P2P Working Group, certainly thinks the meeting is about research:
 

NIH is hosting a Pathway to Prevention workshop to identify gaps in scientific research, to guide a path forward for NIH research. Bob Miller, March 11, 2014 CFSAC Transcript, p. 114.

 
But at other points, it appears the focus is back on the case definition:
 

The purpose of the Pathways to Prevention Program for ME/CFS is to evaluate the research evidence surrounding the outcome from the use of multiple case definitions for ME/CFS and address the validity, reliability, and ability of the current case definitions to identify those individuals with or without the illness or to identify subgroups of individuals with the illness who might be reliably differentiated with the different specific case definitions. Dr. Susan Maier, December 11, 2013 CFSAC Minutes, p. 16.

 
Doesn’t this assessment of multiple case definitions and what research tells us about subgroups sound like what the IOM panel is doing right now? And if IOM is already doing this, why do we need a separate process at NIH where the decision makers are ALL non-ME/CFS experts?
 

The expert gets to decide, right?

 
I went back through CFSAC minutes and other documents, looking for the first time Dr. Maier or another federal employee told an ME/CFS audience that the P2P Panel would be composed entirely of non-ME/CFS experts. It was January 27, 2014 in her presentation to the Institute of Medicine, when Dr. Maier offered her ill-fated “jury model” analogy. Dr. Susan Maier, Institute of Medicine Public Meeting, January 27, 2014, Minute 6:25.

Just to be clear, the earliest public discussion of P2P was October 2012, but it wasn’t until almost 16 months later that Dr. Maier finally told us that the P2P Panel would have no ME/CFS experts on it. Why did it take so long? Maybe the better question is why January 2014. Would Dr. Maier have talked about her jury model of “They don’t know, they don’t know anything” if I had not already exposed this here on January 6, 2014? Maybe, but it strikes me as more than odd that despite at least two opportunities to tell CFSAC about the “jury model,” she waited until the IOM meeting to actually disclose it.

But the government says Don’t Worry! Your experts are participating!
 

The working group will meet to develop the questions that will form the basis of the evidence-based review, develop workshop themes and structures, suggest speakers, and develop an agenda for the meeting. The deliverable from this meeting will be a list of questions for the evidence review, themes for the workshop, perhaps a draft agenda, and any speaker names for those who will speak at the meeting. Dr. Susan Maier, December 11, 2013 CFSAC Minutes, p. 16-17.

Our experts and I had real input into the agenda and questions. The Working Group drove the agenda, and we will participate in the Workshop. I believe the prep work for the Workshop is being done with strong representation from our illness, laying the foundation for a good outcome. Bob Miller, January 12, 2014.

 
It sure sounds like that Working Group finalized the questions for the evidence review:
 

The Key Questions were defined by the Working Group of content experts at a planning meeting organized by the NIH Office of Disease Prevention. May 2, 2014 Email from CFSAC listserv.

 
There’s a problem, everybody. Multiple sources who are in a position to know what happened at the January 2014 Working Group meeting told me that the questions in the study protocol were not the questions defined at the meeting. Did something happen between that January meeting and the release of the study protocol? I don’t know whether someone continued to tinker with the questions, or why the Working Group was not consulted. But either the questions have been significantly changed, or the information from my sources is deeply flawed.

Why is this a problem? Well, in addition to all the problems I documented with the study protocol, those questions form the structure of the P2P Workshop. Those questions give us a pretty good idea of what will be on the Workshop agenda, and I will supplement that with additional exclusive information in my next blog post.

 

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On It or In It?

Posted on May 12, 2014 by Jennie Spotila
I wish this was my bed.

I wish this was my bed.

I’ve been spending a lot of time in bed, recently. This is unusual for me. Usually, I’m ON the bed but not IN the bed. I see a really big distinction.

On a normal day, I’m out of bed in the morning and on the bed in the afternoon. If I’m on the bed, it is usually because I need to have my legs up and my dog close by. The couch is just not as restful and comfortable as my bed. I might be reading or knitting or just listening to music, but being on the bed doesn’t mean I’m having a bad or low-functioning day. I might even nap with a blanket thrown over my legs, but I’m able to get back out of bed at dinner time. And after dinner, I am almost always on the bed – again for the physical comfort factor.

Being IN the bed is completely different. In bed means I am under the covers, and almost always lying down. If I am in the bed during the day, I’m crashing. It means I’m in pain, I’m unable to think or concentrate. Actually, it looks like this. I’m not reading or knitting. I might be looking at the tv, but it’s unlikely that I’m actually watching it with any concentration. In bed + day time = bad news.

This in vs. out distinction never struck me as remarkable until a few weeks ago. More often than not, I’ve been in bed, under the covers and done for the day, by 3:30 pm. This was happening even before my post-IOM meeting crash. I was just done. There were things I needed and wanted to do, but I couldn’t  – could not – do anything except collapse in bed.

Part of the issue is cognitive activity. There are advocacy issues sucking up huge amounts of my energy (including IOM and P2P) and causing increased stress. And the other issue has actually been my desire to test treatment benefit. I’ve been getting weekly saline infusions, and they make me feel better, so I’ve been pushing a bit to see if it is improving my functionality (jury is still out on that one).

There’s a prevailing misconception among people who are not familiar with ME/CFS (and even some who are!) that patients stay in bed because they want to, or that we don’t push ourselves hard enough. I can only speak for myself, but this is not the case for me. As much as possible, I resist being in or on the bed. I resist napping. I push my body and brain to the limit every day. Not a single day goes by that I end it saying, “Gosh I could have done more today.” I might say I wanted to do more or I should have done more. But never once do I think I did less than I could have done. I am always always ALWAYS disappointed by what I didn’t do. I never choose rest or leisure over productivity – and probably to my detriment.

I tend to be pretty hard on myself, and I’ve been trying to force myself to stay out of bed. Or at least to just be on it and distract myself a bit. But it was no good. Each day I caved and got in the bed. Suffering doesn’t make much sense, just to be able to tell myself I wasn’t in bed. This is not a competition. If I feel that bad, I should take care of myself and not increase my suffering out of some misguided stoicism.

So when I felt it coming on again yesterday afternoon? I trusted that feeling, and I got IN the bed. Tomorrow is another day, and hopefully I’ll get back out of bed again. There are many ME/CFS patients who are so ill, getting out of bed is more of a dream than a plan. I’m lucky that it’s still my plan.

 BmssU3fCcAAe6lj

 Read other May 12 Blog Bomb entries here.

 

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IOM: Sum of the Whole Matter

Posted on May 10, 2014 by Jennie Spotila
Credit: Robert Van Vranken

Credit: Robert Van Vranken

The IOM panel on ME/CFS held its second (and likely final) public meeting on May 5, 2014. On display near the meeting room was this painting by Robert Van Vranken: Untitled (Everything at once, or one thing at a time?). (read more about the painting here) Written on the wall within the painting is the beginning of a quote from Prometheus Unbound, “Hear the sum of the whole matter in the compass of one brief word . . .”

To hear the sum of the whole matter in one brief word: this is precisely the challenge before us. How do we convey the full sum of ME/CFS – all of the issues, science, suffering, truth – in a brief word? When we say ME or PEM or cognitive dysfunction, will the IOM hear the full compass of what we mean? And can their diagnostic criteria – in a few brief words – transmit the fullness of that knowledge to the world?

This was the overarching theme of the public session on May 5th: communicating the reality of ME/CFS, and the uncertainty over whether the message was heard.

Agenda Structure

The agenda for the meeting was organized around gaps in the panel’s knowledge. A patient panel was asked to address obstacles in interacting with the healthcare system. Dr. Leonard Jason presented data on challenges and issues in the diagnostic criteria. Dr. Akifumi Kishi presented on sleep disturbance and Dr. Gudrun Lange presented on neurocognitive impairment, two issues that rank high in studies of ME/CFS symptoms. Every invited speaker was given a list of questions by the panel to answer in their presentations.

Taken as a whole, the speakers emphasized the core symptoms of PEM, sleep disturbance and cognitive impairment, and Dr. Jason addressed key issues in devising diagnostic criteria. These are critical areas for the committee to consider. Some advocates asked why no immunologist or expert clinician like Dr. Peterson was invited. But there are committee members with that expertise: Dr. Klimas for clinical immunology, and Drs. Klimas, Bateman, Lerner, Natelson and Rowe for experience treating people with ME/CFS. The panel does not have expertise in sleep or cognitive impairment, and Dr. Jason’s expertise in ME/CFS criteria issues is unparalleled. The meeting agenda structure plugged some of those holes for the IOM panel.

Patient Presentations

Two patients (Joe Landson and Bob Miller) and two caregivers (Denise Lopez-Majano and Annette Whittemore) spoke on the obstacles that ME/CFS patients face in diagnosis and healthcare. The presentations were moving, and all four acknowledged their good fortune in being able to get as much from the healthcare system as they have.

Joe Landson and Annette Whittemore pointed out that patients usually know more than their doctors, but remain hopeful that they will find help and confirmation of the diagnosis. Annette told several stories about doctors refusing to offer treatment to her daughter Andrea because she carries the CFS label. Denise Lopez-Majano talked about how doctors gave her no guidance on how to care for her sons or help them recover. Even basic advice about PEM and cognitive impairment would have reduced their suffering. Bob Miller described how it wasn’t until he found Dr. Peterson fifteen years after getting sick that he finally received adequate diagnostic testing and treatment.

Both cognitive impairment and PEM featured prominently in the presentations. Joe talked about how the “clutch in his brain has snapped,” and that even simple cognitive tasks are now beyond his capabilities. Denise described her son Matthew losing focus while speaking or eating, as if “his brain was stuck on hold.” All the panelists described the unpredictability and severity of PEM, offering specific examples. I’m not sure if the IOM panelists keyed in on the significance of one of Denise’s comments: that her sons were prescribed exercise only after they were diagnosed with ME/CFS.

Dr. Lily Chu and Dr. Klimas were both interested in the presenters’ thoughts on the name of this disease. While all four were emphatic that “CFS” should be abandoned, only Annette Whittemore offered an alternative: Ramsay’s disease. Denise, Bob and Joe all declined to specify what name they preferred. Many advocates saw this as a squandered opportunity. None of the speakers addressed the fact that ME already has a diagnostic code, nor did they connect the name question back to the diagnostic criteria.

The sense I got was that the speakers felt put on the spot by the name question, as if they were being asked to speak for the entire advocacy community, but I think they could have offered their own opinions. The IOM requested we address the name question in written comments for this meeting. In my own written submission to the IOM panel, I said, “If your case definition resembles the traditional definition of myalgic encephalomyelitis, as I believe it must, then I urge you to retain the traditional name as well.” I hope many other people expressed their opinions, too.

Dr. Jason and Criteria Challenges

Dr. Jason was asked to address many questions in his presentation, and given only 30 minutes in which to do it. I strongly recommend watching the video of his presentation to get the full details. In my opinion, the most important take away was the issue of reliability and criterion variance.

Studies have shown that anywhere from 50-90% of people who meet the Fukuda definition also meet the Canadian Consensus Criteria. Dr. Jason said that one possible explanation for this wide variation is that doctors are not applying the criteria consistently. Without an agreed upon set of biomarkers or assessment tools, there is potential for great differences in the actual application of any case definition.

One way to solve this problem is with an assessment tool like the DePaul Symptom Questionnaire. Dr. Jason presented data showing that the DSQ can distinguish between ME/CFS and depression with 100% success. However, the DSQ is not as good at distinguishing ME/CFS from autoimmune diseases like lupus or multiple sclerosis, and his research is ongoing.

Another way to create better diagnostic criteria is to use frequency and severity cutoff scores. This means that we don’t just ask if the person has a symptom, such as dizziness. We have to ask how frequently the person is dizzy and how severe the dizziness is. Dr. Jason presented a powerful slide showing that when a definition requires symptoms to occur a little of the time and be mild (referred to as 1/1), almost 34% of healthy controls meet the Fukuda definition. But when symptoms must occur about half the time and be moderate in severity (referred to as 2/2), healthy controls are almost completely eliminated.

The many questions from the IOM committee members may give us clues about what they are grappling with behind closed doors.

  • Why is PEM not reported by 100% of patients? Answer: self-report questionnaires are not perfect, patients may have adapted coping skills to reduce PEM, or it may not be present in 100%.
  • Is both frequency and severity required? Answer: identifying low frequency is important because it is less debilitating to patients.
  • Impact of even higher cutoffs, gradual onset, psychiatric comorbidity, gender, ethnicity, controls, and good day vs. bad day? Answer: much of this has not been studied, and data is limited by the collectors (such as biobanks).
  • How do we create a definition that is not too complicated for clinicians to use? Answer: focus on the core symptoms, and give doctors tools like questionnaires and scoring rules to help them make the diagnosis.

This issue of creating a simple definition came up during the patient presentations, too. Several people supported a one sentence description of the essence of the disease. In order to be inclusive, subtypes were suggested as ways to separate patients within that broader category. To be honest, this makes me nervous. It opens the door to a broad definition, with subtypes used to truly delineate those with this disease. I’m not sure that’s much different from what we have now. However, Dr. Jason did present his data on the core symptoms (PEM and cognitive dysfunction), and showed that other symptoms may cluster patients with immune or autonomic abnormalities. That paradigm was well reflected in the patient presentations.

Sleep and Cognitive Dysfunction

Following in the theme of core symptoms, Dr. Akifumi Kishi presented his data on sleep dysfunction in ME/CFS. I found his presentation very difficult to follow, and was disappointed that he did not provide a more comprehensive survey of this area of research. His data show that ME/CFS patients have abnormalities in their sleep stage transitions, but not in the actual stages themselves. The data also show that ME/CFS patients slept better after exercise, which is completely at odds with what many of us have experienced.

Dr. Kishi was pressed hard by the panel on multiple issues related to study design, statistical power, outcome measures, and comparison to overtrained athletes. Dr. Kishi could not answer many of these questions due to a lack of data or failure to consider the issues during study design. It was disappointing that his studies have been so small and so preliminary, and I’m not sure how useful this data will be to the IOM panel.

Dr. Gudrun Lange gave an overview of cognitive dysfunction in ME/CFS, including her fMRI studies and patient evaluations. Overall, her data show that ME/CFS patients have impaired processing speed and working memory. In untimed tasks, they show little impairment. Decreased attention and concentration, less information available “online,” and an inability to organize learning and make quick decisions are all manifestations of the dysfunction. Her imaging studies show that even when ME/CFS patients complete the same tasks at the same level as healthy controls, they need to use more of the brain to do so.

Dr. Lange was questioned on comparisons to other groups, such as sleep deprived controls and patients with fibromyalgia or ADHD. She also highlighted the differences between ME/CFS cognitive dysfunction and those with dementia or stroke. ME/CFS patients are very different, and testing conducted by neuropsychologists not familiar with the disorder can appear to give normal results when the impairment may actually be severe. While Dr. Lange said that no short form testing has been validated in ME/CFS patients, she suggested giving a patient 6 or 7 steps of complicated driving directions and asking them to repeat it back. We rarely can.

It was fitting for the meeting to end on the subject of cognitive dysfunction, since that had been a significant focus of the patient/caregiver panel.  And I can share one example of my own cognitive fallout from attending the meeting. I traveled to the meeting with a friend by car (unable to hold directions in my head, as Dr. Lange had highlighted). I had the following text exchange with my husband after a pit stop on the way home, perfect evidence of me losing focus and substituting words:

 IMG_2887

 

The Elephant Not In The Room

One audience member commented to me that this meeting was very different from the January public meeting because of the absence of protesting advocates. Bob Miller said during his remarks that patients are protesting the meeting because they have no faith in the system. If the patient community actually believed the IOM process would help them, Bob said, the room would be filled.

My position on participating in the IOM process is well-known. I’ve been criticized for it, as were the advocates who chose to participate as panelists at this meeting. I won’t revisit the controversy in detail here. All I can say is that while some people noted the absence of many advocates, that absence made it easy for the panel to focus on its own agenda. When they asked for opinions on the name, they only heard the uncertainty of several panelists and whatever was submitted in writing. Anything the other advocates would have said was simply lost. Those of us who have chosen to provide input to the committee are trying to represent the diversity of opinion in our community, but I’m sure we are not fully successful.

“Hear the sum of the whole matter in the compass of one brief word.” Have we done enough to tell the IOM panel the truth about this disease? Have we done enough to point them in the right direction, and give them evidence sufficient to reach the right conclusions? Were the protesters heard through their silence? Have we been effective in combining the power of that silent protest with input from those willing to speak and write to the panel? Will it be enough?

We can only guess, and hope, and try, and wait.

 

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Protocol for Disaster?

Posted on May 2, 2014 by Jennie Spotila

disasterThe study protocol for the systematic review of ME/CFS was posted by the Agency for Healthcare and Research Quality yesterday. It’s a recipe for disaster on its own, and within the broader context of the NIH P2P Workshop it’s even worse. Let me show you some of the reasons why.

Remind Me What This Is

The systematic evidence review is the cornerstone of the P2P process. The P2P meeting on ME/CFS will feature a panel of non-ME/CFS experts who will produce a set of recommendations on diagnosis, treatment, and research.

Because the P2P Panel members are not ME/CFS experts, they need background information to do their job. This systematic evidence review done by the Oregon Health & Science University under contract to AHRQ will be that background information. The systematic evidence report will be presented to the Panel in advance of the public P2P meeting, and will be used to establish the structure of the meeting as well.

The systematic review is the foundation. If done correctly, it would be a strong basis for a meaningful workshop. If done poorly, then everything that follows – the workshop and the resulting recommendations – will crumble. Based on the protocol published yesterday, I think “crumble” is putting it mildly.

The Key Questions

You can’t get the right answer if you don’t ask the right questions. (Dr. Beth Collins-Sharp, CFSAC Minutes, May 23, 2013, p. 12)

As I wrote in January, the original draft questions for the evidence review included whether CFS and ME were separate diseases. That question is GONE, my friends. Now the review is only looking at two things:

  • What methods are available to clinicians to diagnose ME/CFS and how do the use of these methods vary by patient subgroups?
  • What are the benefits and harms of therapeutic interventions for patients with ME/CFS and how do they vary by patient subgroups?

These questions are based upon a single and critical assumption: ME and CFS are the same disease. Differences among patient groups represent subtypes, not separate diseases. The first and most important question is whether the ME and CFS case definitions all describe one disease. But they’re not asking that question; they have already decided the answer is yes.

The study protocol and other communications from HHS (including today’s CFSAC listserv message) state that the P2P Working Group refined these study questions. The implication is that since ME/CFS experts and one patient served on the Working Group, we should be satisfied that these questions were appropriately refined. But what I’m piecing together from various sources indicates that the Working Group did not sign off on these questions as stated in the protocol.

Regardless of who drafted these questions, they cannot lead to the right answers because they are not the right questions. And when you examine the protocol of how the evidence review will be conducted, these questions get even worse.

Protocol Problems

The real danger signals come from the description of how this evidence review will be done. The issue is what research will be included and assessed in the review. For example, when asking about diagnostic methods, what definitions will be considered?

This evidence review will include studies using “Fukada [sic], Canadian, International, and others“, and the Oxford definition is listed in the table of definitions on page 2 of the protocol. That’s right, the Oxford definition. Oxford requires only one thing for a CFS diagnosis: six months of fatigue. So studies done on people with long-lasting fatigue are potentially eligible for inclusion in this review.

The description of the population to be covered in the review makes that abundantly clear. For the key question on diagnostic methods, the study population will be: “Symptomatic adults (aged 18 years or older) with fatigue.” There’s not even a time limit there. Three months fatigue? Four? Six? Presence of other symptoms? Nope, fatigue is enough.

There is a specific exclusion: “Patients with other underlying diagnosis,” but which conditions are exclusionary is not specified. So will they exclude studies of patients with depression? Because the Oxford definition does not exclude people with depression and anxiety. We’ve seen this language about excluding people with other underlying diagnosis before – and it results in lumping everyone with medically “unexplained” fatigue into one group. This protocol is set up to result in exactly that. It erases the lines between people with idiopathic chronic fatigue and people with ME, and it puts us all in the same bucket for analysis.

And what about the key question on treatment? What studies will be included there? All of them. CBT, GET, complementary/alternative medicine, and symptom-based medication management. It’s not even restricted to placebo trials; trials with no treatment, usual care, and head-to-head trials are all included.

Let’s do the math. Anyone with unexplained fatigue, diagnosed using Oxford or any other definition, and any form of treatment. This adds up to the PACE trial, and studies like that.

But it’s even worse. The review will look at studies published since January 1988 because that was the year “the first set of clinical criteria defining CFS were published.” (page 6) Again, let’s do the math: everything published on ME prior to 1988 will be excluded.

Finally, notice the stated focus of the review: “This report focuses on the clinical outcomes surrounding the attributes of fatigue, especially post-exertional malaise and persistent fatigue, and its impact on overall function and quality of life because these are unifying features of ME/CFS that impact patients.” (page 2) In other words, PEM = fatigue. And fatigue is a unifying concept in ME/CFS. Did anyone involved in drafting this protocol actually listen to anything we said at last year’s FDA meeting?

Bad Science

Credit: ElodieUnderGlass

Maybe you’re thinking it’s better for this review to cast a broad net. Capture as much science as possible and then examine it to answer the key questions. But that’s not going to help us in this case.

This review will include Oxford studies. It will take studies that only require patients to have fatigue and consider them as equivalent to studies that require PEM (or even just fatigue plus other symptoms). In other words, the review will include studies like PACE, and compare them to studies like the rituximab and antiviral trials, as if both patient cohorts were the same.

That assumption – that patients with fatigue are the same as patients with PEM and cognitive dysfunction – is where this whole thing falls apart. That assumption contaminates the entire evidence base of the study.

In fact, this review protocol makes an assumption about how the Institute of Medicine study will answer the same question. It is possible (though not assured) that IOM will design diagnostic criteria for the disease characterized by PEM and cognitive dysfunction. But this evidence review is based on an entirely different patient population that includes people with just fatigue. The conclusions of this evidence review may or may not apply to the population defined by the IOM. It’s ridiculous!

But it’s the end use that really scares me. Remember that this systematic evidence review report will be provided to that P2P Panel of non-ME/CFS experts. The Panel will not be familiar with the ME/CFS literature before they get this review. And the review will conflate all these definitions and patient populations together as if they are equivalent. I think it’s obvious what conclusion the P2P Panel is likely to draw from this report.

I would love to be wrong about this. I would love for someone to show me how this protocol will result in GOOD science, and how it will give the P2P Panel the right background and foundation for the recommendations they will draft. Please, scientists and policy makers who read this blog – can you show me how this protocol will produce good science? Because I am just not seeing it.

What Do We Do?

This protocol is bad news but it is by no means the last word. Plans are already in motion for how the advocacy community can respond. I will keep you posted as those plans are finalized.

Make no mistake, this evidence review and P2P process are worse than the IOM study. We must respond. We must insist on good science. We must insist that our disease be appropriately defined and studied.

 

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Comment on FDA Draft Guidance

Posted on April 29, 2014 by Jennie Spotila

I submitted the following comments to FDA on its Draft Guidance to Industry on ME/CFS Drug Development. Please note that there is a 5,000 character limit on electronic comments submitted through regulations.gov, so I sent my comments in by mail. Full instructions for submitting comments are at the bottom of this post. Disclaimer: I am a member of the FDA’s Patient Representative Program. However, this post represents my personal opinions and are not comments made in any official or formal capacity.

Thank you for this opportunity to provide comments on the FDA’s Guidance for Industry Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment.

I am very pleased that FDA has issued Draft Guidance for Industry on developing drugs to treat ME/CFS. It’s clear that FDA listened to the patient experiences recounted at the April 25-26, 2013 Patient Focused Drug Development Meeting. I offer the following comments to improve the draft guidance:

Case Definition:

The Guidance states that FDA does not recognize or prefer any specific case definition for ME/CFS. FDA further explained at the April 23, 2014 webinar meeting that drug sponsors will be permitted to select criteria and expected to provide justification for the same. While this flexibility may be preferred by FDA and sponsors, I believe it creates potential problems.

As FDA is aware, there are multiple case definitions in use for ME/CFS. These definitions range from the narrow Canadian Consensus Criteria for ME/CFS to the very broad Oxford case definition. Indeed, the Oxford definition only requires a patient to have six months of fatigue to be diagnosed with CFS, and conditions like depression or anxiety are not exclusionary. As a result, many patients who meet the Oxford definition will not have most of the symptoms described by patients at the PFDD meeting, including the hallmark criteria of post-exertional malaise and cognitive impairment.

By allowing a sponsor to choose a definition as broad as Oxford, FDA runs the risk of a drug being marketed for ME/CFS when in fact it has only been tested on patients with six months of fatigue. There is no equivalence between six months of fatigue under Oxford and any of the other more restrictive criteria for ME/CFS. A drug that treats fatigue may not be safe and/or effective in ME/CFS patients, and vice versa.

As FDA has rightly said, there is a serious unmet need for ME/CFS treatments, and such products may qualify for one or more expedited review programs. This could potentially give unfair advantage to sponsors of anti-fatigue drugs who never test the treatments in actual ME/CFS patients because they use the Oxford criteria.

FDA may not be prepared to endorse a single case definition at this time, but I urge FDA to be very clear on the difference between chronic fatigue (a symptom) and ME/CFS (a disease). These categories cannot be treated as synonymous. FDA should not accept the use of the Oxford criteria for CFS under any circumstances because those patients may only have the symptom of chronic fatigue.

Measuring Effectiveness:

The Guidance states that efficacy must be demonstrated in improving ME/CFS symptoms. At the April 23rd webinar, FDA clarified that efficacy can be demonstrated in any one or more of ME/CFS symptoms, and that PRO instruments are required while objective measures are optional.

While it is true that no objective measure or biomarker is universally accepted in ME/CFS, I believe that objective measures play a very important role in assessing treatment efficacy. Specifically, there are cheap and effective ways of measuring functional improvement, including actimeters (e.g. Fitbit and similar devices) and objective cognitive testing. Claims of functional improvement based solely on PROs will not be as strong as functional improvement measured with such objective tools.

PRO instruments certainly play a role in measuring symptom changes, and I am glad FDA is willing to accept PROs validated in other conditions. However, I know from my own experience how difficult it can be to recall or perceive changes in symptom severity. I urge FDA to encourage sponsors to use actimeters or cognitive testing to objectively measure functional changes in patients.

I also strongly recommend that FDA require sponsors to measure changes in symptoms and functionality throughout clinical trials. It is well-known that ME/CFS symptoms fluctuate over time, and sometimes the causes of such fluctuations cannot be identified. A clinical trial that only measures symptoms on the trial start date and the trial end date will be unable to control for such changes. This could result in blunted or inflated efficacy data. While measuring multiple time points will add to the cost of trials, it will more accurately capture any treatment effect (and side effects).

Trial Duration:

The draft Guidance states that sponsors should conduct 24-week clinical trials in ME/CFS patients. However, many patients have reported extreme sensitivity to medications. A 24-week trial may not be long enough to allow patients to ramp up to an effective dose if they must begin at very low doses to avoid severe side effects. In addition, ME/CFS patients frequently must wean down medication doses very slowly to prevent withdrawal symptoms, even if patients with other conditions do not need the same time span to stop the medication. FDA should be aware of both of these factors, and be prepared to instruct sponsors that longer trials may be required to avoid high drop out rates and serious side effects.

Placebo Selection:

Many patients, myself included, experiment with intravenous saline to treat orthostatic intolerance and fatigue symptoms. Therefore, saline may not be a true placebo for drugs administered by IV. This is especially true in patients who have not tried IV saline before. Clinical trials of IV drugs should begin with at least 4 weeks of IV saline for all patients, before beginning courses of treatment or placebo. This will enable sponsors to capture any effect of the IV saline alone in all subjects, and thus better measure actual clinical benefit of the treatment.

Again, thank you for the opportunity to comment on this important Guidance to Industry.

  • To submit an electronic comment, go to http://www.regulations.gov and use the docket number FDA–2014–D–0264, or try this direct link. Use the “Comment Now” button to open up a screen to enter your comments.
  • To submit a written comment, be sure to list the docket number FDA–2014–D–0264 on your letter and send it to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852

 

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FDA Guidance: Doors Open

Posted on April 25, 2014 by Jennie Spotila

Clipart Illustration of an Open Office Door With An Open Sign HaOn Wednesday, April 23rd, the FDA hosted a webinar to explain the Draft Guidance for Industry Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Development Drug Products for Treatment. FDA briefly reviewed the document and took questions in real time. See my original review of the Guidance document for more details on the various elements of the Guidance. This post focuses on what we learned in the webinar.

Dr. Janet Maynard began by explaining that a Guidance summarizes FDA’s current thinking on a topic, and it is intended to assist pharma in developing drugs by establishing expectations for the approval process. She said it is not a “roadmap” as every drug is different. However, Dr. Maynard said a Guidance can catalyze drug development, and that is what FDA is hoping for here. Even though it is in draft form, this Guidance is in effect now and sponsors can rely upon it in discussing clinical trials with FDA.

As I’ve noted previously, FDA does not have a preference for one ME/CFS case definition over another. Drug sponsors can select among the ME/CFS case definitions, and they must provide FDA with justification for that choice. The goal is a well defined patient population, and FDA believes that is achievable here as long as the sponsor is very clear about the criteria.

The Guidance states that clinical trial endpoints (drug effects) should be measured with Patient Reported Outcomes or PROs. Dr. Badrul Chowdhury from FDA stated that PROs are preferred because this disease is currently based on patient reported symptoms. Objective measures could also be used if they are meaningful, but there are not accepted objective measures at this time.

My understanding is that a drug that changes NK cell test results will not be seen as “effective” without a PRO that indicates the patient feels better. The same is true for exercise testing. A drug that improved anaerobic threshold measures would still need to improve how the patient feels or functions. However, FDA was clear that they are open to using PRO instruments developed for other conditions (which is good because they could be used now) or working with sponsors in developing new PROs, such as one specifically designed to measure an improvement in post-exertional malaise.

Drug safety is always a concern, especially in ME/CFS where drugs are likely to be used for a long time. One question asked about safety data required in drug repurposing trials, and FDA said that they would consider safety data from other studies but there would still need to be a trial in an ME/CFS population. Dr. Maynard said, however, that in balancing safety with long term risks of the disease, FDA is very focused on evidence of efficacy because treatments are needed.

A number of questions focused on issues related to combination drugs. This is not surprising, given that one clinical trial of a combo treatment is currently enrolling. There are rumors of one or two other possible combination treatments in the works, too. FDA pointed out that clinical trial design of combination treatments is challenging, and they encouraged possible sponsors to request meetings with the review division to discuss as early as possible.

In response to a question about natural history, FDA said that sponsors will not be required to show data on the natural history of ME/CFS. Data from the placebo arm of the trial can be sufficient. Another question focused on the inclusion of homebound patients in clinical trials. FDA said they encourage including such patients, and noted that endpoints should be tailored to that specific population. A panelist also noted that a severely impaired population might show a better efficacy of a treatment and that would be an advantage to such a trial.

When asked if FDA understood the desperation of ME/CFS patients and the dire need for treatment, FDA replied that this is precisely why they prepared this Guidance. Dr. Chowdhury said that guidance documents are not common in conditions that do not already have drugs moving through the pipeline. FDA hopes this Guidance will encourage drug development, but the only outreach to drug developers is through the Federal Register. While that is disappointing, Dr. Maynard and the other panelists repeatedly said that they are ready to work with sponsors. They encouraged early meeting requests so that clinical trial design could be discussed. They are willing to be flexible on endpoint measures. In essence, the doors are open.

What happens next? The public is strongly encouraged to submit comments on the Guidance (instructions below). If you think FDA has gotten anything wrong, then please submit a comment. I’ll share my own public comment with you next week.

  • To submit an electronic comment, go to http://www.regulations.gov and use the docket number FDA–2014–D–0264, or try this direct link. Use the “Comment Now” button to open up a screen to enter your comments.
  • To submit a written comment, be sure to list the docket number FDA–2014–D–0264 on your letter and send it to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852

 

Disclaimer: I am a member of the FDA’s Patient Representative Program. However, this post represents my personal opinions and are not comments made in any official or formal capacity.

 

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Guidance from FDA

Posted on April 21, 2014 by Jennie Spotila

This Wednesday, FDA will host an informational webinar about the Draft Guidance to Industry on Drug Development for ME/CFS. I hope you can attend and learn more about the Guidance document, because public comments are due May 12, 2014! This document is the major outcome from last year’s Drug Development meeting, and it is really critical that we provide our input before the document is finalized.

I will post a summary of the webinar and my own public comments on the document by the end of the week (I hope!).

 

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Research Roadmap

Posted on April 14, 2014 by Jennie Spotila

Road MapThe Research Recruitment Working Group of the CFS Advisory Committee has been formulating recommendations that could potentially change the direction of ME/CFS research at NIH. Not much time has been spent on it at the last two meetings, but I think you need to pay attention to this. Dr. Dane Cook, chair of the Working Group, spoke with me about where they’re headed.

The Working Group was charged with two tasks: 1) increase awareness among researchers about ME/CFS research and 2) suggest strategies to increase the number of interested researchers who will apply for funding. Most advocates, myself included, have argued for the “build it and they will come” approach. If more money is made available for ME/CFS research, then more researchers will apply. Dr. Cook pointed out that CFSAC has been recommending increases in funding and RFAs for years without any success. In his opinion, it is time to try a different recommendation strategy.

Dr. Cook and the Working Group presented interim reports at the December 2013 and March 2014 CFSAC meetings. The Group has gathered data on the low number of CFS publications relative to the number of publications on both fatigue and fibromyalgia. They have also identified multiple barriers to increasing the number of interested researchers and retaining them in the field. I asked him to walk me through the three prongs of the Group’s current approach, with the caveat that this is not the final recommendation from the Working Group.

A Research Agenda Informed by the IOM and P2P Reports

The first step in the research road map is to articulate a clear research agenda based on the information and recommendations from the 2011 NIH State of the Knowledge meeting, as well as the forthcoming IOM and P2P reports. Combined, these three reports should identify gaps in the research and the priority areas for future inquiry. The IOM report may also resolve the dispute over the case definition, although it should be noted that IOM is creating a clinical case definition not a research definition.

Dr. Cook was pressed hard at the March 2014 meeting on the issue of urgency. The P2P report will be issued at the end of 2014, and the IOM report is not due until March 2015. The formulation of a clear research agenda wouldn’t begin until after that. Billie Moore and other CFSAC members expressed dismay at this timeline, and pushed for an immediate RFA. Meanwhile, a recent Congressional effort made a similar request of NIH, but this has come under fire from some advocates who believe that no money should be requested from NIH without guarantees of how it will be spent. They point to the recent denial of funding to Dr. Lipkin as proof that NIH cannot be trusted to make the right grant decisions.

Dr. Cook told me that the delay of waiting for the reports is the hardest issue for him personally. He would much rather see an increase in funding immediately. However, he pointed out that CFSAC has already pushed for this for many years. His assessment is that if CFSAC recommends another RFA now, the answer from HHS will be that they need to wait for the reports. Dr. Cook’s goal is to provide so much evidence of necessity that HHS will be compelled to act.

Championed by the Trans-NIH Working Group

The second prong of the road map is for the research agenda to be clearly communicated and championed by the Trans-NIH ME/CFS Working Group. Dr. Cook’s sense is that NIH is generally supportive of how he’s been working on this charge, but he did not articulate what “championing” would look like.

It’s important to remember that the Trans-NIH Working Group does not have a research budget, nor does it make the decisions on funding ME/CFS grants. But what it can do is bring people together from the NIH Institutes to promote ME/CFS research at NIH. Any step in that direction is a positive one, as long as the research is physiologically oriented and focused on the correct patient cohorts. Whether this could be achieved – and to what extent the Trans-NIH Working Group would evangelize it – is not entirely clear to me.

Strong Infrastructure

The final prong of the road map is to support ME/CFS research with a strong infrastructure. Dr. Cook is passionate about this, and believes that it could be undertaken immediately without waiting for the IOM and P2P reports. Currently, data sharing among ME/CFS researchers is piecemeal. Many researchers use REDCap to collect their data, and the system is designed to build and manage surveys and databases online. It’s an electronic data capturing system, not a system for aggregating and sharing data.

The National Database for Autism Research (NDAR) is a striking alternative model. NDAR was launched by NIH in 2006, and it offers both a data repository to facilitate data sharing and standardization, and a scientific community platform that offers access to other research repositories housed by other institutions. Applicants for NIH funding are strongly encouraged to contribute their data to NDAR, and data on almost 70,000 individuals with autism are available. Several NIH Institutes provide funding for NDAR, averaging about $2 million per year.

NDAR is far larger and more sophisticated than any ME/CFS data effort. Dr. Cook believes that ME/CFS research is in desperate need of such a resource. He also said that this could be pursued immediately, without waiting for the IOM and P2P reports. The big question is (as always) funding. An NDAR representative told me that the system could be rolled out for another disease area, such as ME/CFS, for about a quarter of the annual NDAR investment. But still, is NIH willing to invest $500,000 per year in building such a system for ME/CFS?

Where From Here

Dr. Cook indicated that the Working Group is continuing to refine its recommendation. His CFSAC term expires in early May, but he hopes to remain on the Working Group to continue and support the effort to finalize a recommendation to the Secretary.

I think many important questions remain: Is it appropriate to make the RFA contingent on the release of the P2P and IOM reports? Is such a delay acceptable? Who will be charged with articulating the research strategy? Will that person/group be willing and able to depart from the P2P and IOM recommendations if needed? Will the Trans-NIH Working Group champion this agenda and request an RFA? What does that look like? Who will be tasked with creating an NDAR-like infrastructure? Who will pay for it?

And the obvious question is: how long do ME/CFS stakeholders have to wait to see the investment of funding that this we so desperately need and deserve?

 

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Don’t Silence Yourself

Posted on April 8, 2014 by Jennie Spotila

On May 5th, the IOM panel creating new diagnostic criteria for ME/CFS will hold its second public meeting. The only way you can provide input is by submitting written comments, unless you are an invited speaker. I’m here to plead with you to send your comments to the panel.

black-tape-mouth-shut-no-speaking-700x45_660There’s been another round of the “should we speak or stay silent” debate about this meeting, catalyzed by Eileen Holderman’s public refusal of an invitation to speak. Ultimately, everyone has to do what they believe is right. But as I have said before, I believe the risk of staying silent is simply too great.

Some advocates are in favor of boycotting the IOM meeting and refusing to answer the questions they have posed to the patient community. Their argument is that patient input makes absolutely no difference, and will only be used to legitimize the process of creating a definition to destroy us. They believe in opting out of the process and continuing to seek cancellation of the contract.

That is a huge gamble.

Right now, there are at least eight members of the IOM panel who are trying to create the right case definition. These eight people know the devastation of this disease, and they are working hard to ensure that the case definition serves our interests. They need our help to do it.

HHS blatantly refused to seek our input into the decision to give this contract to IOM. Now IOM is offering us an opportunity to provide input into their decisions. How can we complain about being left out of one decision, and then refuse to provide input into the actual case definition decision? What conclusion will IOM draw from the silence of our community? Will they be impressed with our stance on the moral high ground? Or will they conclude that we must not care that much after all?

Have you seen the agenda for the May 5th meeting? One name stands out: Dr. Megan Arroll, Director of Research for The Optimum Health Clinic in London. The Clinic uses a number of alternative medicine treatments, including techniques derived from the Lightning Process and Mickel Therapy. Their approach is based on the chronic stress model of the disease. So part of the choice we have to make is whether we will cede the floor to this perspective. Should we allow that perspective to go unchallenged and unanswered? Should we leave it to the ME/CFS experts on the panel to make that argument for us?

You have valuable things to say to IOM. I know you do. You have your own experiences with seeking diagnosis and healthcare. I know you have strong opinions about the name. By opting out, you silence yourself. You deny IOM the benefit of your experiences. The IOM panel NEEDS to know what you have been through, and NEEDS to know what you think about the disease name. Chances are, you have something unique to say, something that the rest of us – while we will try to speak for you – might miss. Are you willing to take that risk?

Even if we say everything you would say, there is no substitute for volume. If ten of us say we want the name ME, that’s nice. But if 100 of us, or 1,000 of us say it, it is much harder to ignore. Part of our power comes from numbers. Why should we sacrifice that power? Don’t you think the IOM panel will notice if the meeting room is filled or half empty? Don’t you think someone will count the number of messages they get for this meeting? And if there is anyone on that committee looking for weak spots on our side, don’t you think they will point to lack of participation and use it against us?

If this is war, should we simply abandon one of the battlefields and turn our backs on the fight?

Not me. Time and again, ME/CFS advocates draw parallels to the HIV/AIDS movement. But remember one of the main slogans of that movement: Silence = Death. I will not be silent. I will not be shamed for speaking out to IOM. I say press on all fronts. I say cover all our bases. I say SPEAK NOW! Don’t let this opportunity pass by.

The IOM panel asks “what are the most important issues that healthcare providers should be educated about when it comes to diagnosis of ME/CFS?” So tell them. Tell the panel how long it took you to be diagnosed. Tell them what other diagnoses were considered and why, especially if you were told it was all in your head. Did your doctor tell you to exercise? Did your doctor understand anything about PEM? Has a healthcare provider ever talked to you about cognitive dysfunction? Were you given the information you needed to protect your health and cope with the disease? Do you think your gender, race, or socioeconomic status had any effect on your experience of getting diagnosed? Have you even found a healthcare provider who knows anything about the disease? Have you been harmed by the kind of information put out by organizations like CDC or the American Academy of Family Practitioners?

The IOM panel asks “What are your thoughts on the current terminology used to describe this disease: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome? If you could suggest new terminology, what would you suggest and why?” So tell them. Tell them you hate the name CFS, and why.  Do you like ME/CFS? Prefer ME? Want them to come up with something new? Why? Tell them what you think, or allow them to make these choices in the face of your silence.

If you can, submit your comments before April 23rd to mecfsopensession@nas.edu. But you can submit input any time to mecfs@nas.edu, so don’t give up if you can’t send something in by the 23rd.

You are not limited to these questions, of course. If you want to tell them why you oppose the contract altogether, you are free to do so. If you want to talk about the danger of GET, go ahead. Tell them that you believe there are biomarkers, or that they should adopt the Canadian Consensus Criteria in its entirety, or that this is an autoimmune disorder, or that we need a specialty home. You should tell them whatever you want. I can’t guarantee they will listen. But I CAN guarantee that if you do not speak, they won’t hear you.

 

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