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Posts Tagged ‘IOM’

Burning Underground

September 3rd, 2014 7 comments

Credit: Cole Young*

Just over a year ago, advocate Leela Play noticed something odd on a federal contracting website. What she found was a notice of intent to award a sole source contract to the Institute of Medicine to create clinical diagnostic criteria for ME/CFS. And just like that, the ME/CFS landscape changed.

What followed was a month-long attempt to stop the government from issuing this contract, and when that failed more attempts were made to get the contract rescinded. The advocacy and scientific communities faced divisions over positions and tactics. Meanwhile, the IOM contract has moved towards its conclusion in March 2015.

Current activity – both IOM and advocacy – is smoldering underground. But no one should mistake this period of quiet to mean that nothing is happening.

Where Is IOM?

The process and schedule for this IOM study is set forth in the contract, and is moving pretty much on track. The committee was selected in December 2013, and held two public listening sessions (January and May 2014). The committee has met behind closed doors four times, with a fifth meeting scheduled for this week. Bare bones meeting summaries are posted on the project website after the meetings.

Committee members have reviewed a great volume of material. An extensive literature search has been conducted. In addition, the public has submitted comments and materials over the course of the contract, numbering more than 4,000 pages the last time I checked. There are also indications that the committee may have examined raw data, although details about that are not yet available.

The study seems to be running slightly ahead of the schedule laid out in the contract, at least judging from the meeting dates. If so, then it means the committee is putting the finishing touches on its recommendations and the case definition. The next step is sending the draft report out for peer review, with delivery on track for early 2015.

Where Are We?

As reflected on this and other blogs, discussion forums, and social media, ME/CFS advocacy exploded when we learned about the contract. I’ve compared it to dropping a match on a lake of gasoline. For the most part, we focused our attention outward towards the government, IOM and the media. But at various times, we’ve also focused attention inward. We’ve criticized each other for our positions on the contract, the degree to which we have participated in the process, and for the tactics we’ve used. Sometimes, the criticism has not been constructive. This is not unexpected when people feel cornered and the stakes are high.

DHHS stated at the June 2014 CFS Advisory Committee meeting that it wants to work with the advocacy community on a path forward after the IOM report. As I wrote in my meeting summary, if this “means the kind of involvement we have had to date, then there is nothing to really talk about.” HHS holds all the cards here, and it will take more than token efforts on both sides to actually move forward together. Obviously, this begs the question of whether ME/CFS advocates will even want to move forward with the IOM report. It all depends on what that report says.

What Next?

I think one possible analogy for where we are now is the Centralia mine fire. This fire has been burning in a coal seam beneath the town of Centralia, Pennsylvania for 52 years. Underground coal fires can burn for years undetected. Eventually, the ground collapses in sinkholes, allowing oxygen to rush in and fuel the fire even more.

On the surface, it may not seem like advocates are paying much attention to the IOM study right now. A number of prominent voices in our community have retired (temporarily, I hope) or taken breaks to recover from the crashes brought on by advocacy. The scientific community has not been publicly discussing IOM. And the IOM committee members themselves are bound by very strict confidentiality rules, so they’re not talking either.

Don’t let the quiet fool you. Work has continued on multiple fronts this year, and I expect we will hear developments in the near future. It won’t take much disturbance on the surface to refuel this fire. A sink hole, some oxygen, and we’ll be at it again. What I’m wondering these days is who is going to get burned.

 

*Photo credit: Cole Young, Flickr, Creative Commons license

P2P: The Question They Will Not Ask

July 21st, 2014 37 comments

by Mary Dimmock and Jennie Spotila

cornerstone-contentThe 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.

 

This post was translated into Dutch with my permission.

 

Guest Post: Longtime Patient, New Advocate

June 30th, 2014 12 comments

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.

findyourvoice

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.

Guest Post: CFSAC Testimony of Andrew Bokelman

June 19th, 2014 5 comments

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.

 

Guest Post: CFSAC Comments of Charmian Proskauer

June 17th, 2014 1 comment

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.

 

A Different CFSAC

June 5th, 2014 Comments off

It’s that time again: meaning it is time for another CFS Advisory Committee meeting. Due to the make up day in March, the meetings have fallen very close together. Presumably this spring meeting puts the calendar back on track (but that’s a guess on my part). Key deadlines are upon us, and there are some interesting changes you should also be aware of.

Deadlines You Need to Know

  • The meeting is June 16-17, 2014.
  • If you want to attend in person, you must register by Thursday, June 12th. If you are not a US citizen, the deadline to register was June 5th.
  • If you want to give public testimony in person or over the phone, you must register by Monday, June 9th.
  • According to the Federal Register Notice, if you want to submit written public comments for the record, you must do so by Thursday, June 12th. Be sure to comply with the guidelines on length and file format from the Federal Register Notice.

Many Differences

A number of things will be different about this meeting compared to previous ones:

  • Length – This meeting will be from 12-5pm on June 16th and 9am-5pm on June 17th. This is a switch from the usual two full days for in-person meetings. The Office of Women’s Health was asked about the timing, and OWH stated that the half day on Monday was to avoid requiring everyone to travel on Father’s Day (although presumably some people will still need to do so).
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  • Location – The meeting is in-person (hopefully this is the end of webinars), and it is being held on the first floor of the HHS building in the Great Hall. This has happened only one other time in the history of the Committee: October 2009, immediately after the publication of the XMRV paper in Science. OWH said that the change was made because the usual Room 800 was not available during the month of June.
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  • New MembersAs I pointed out in March, there are five (and soon to be six) vacancies on CFSAC. Four terms expired on May 10, and Dr. Dimitrakoff resigned before the March meeting. In theory, at least four new members should be appointed for this meeting. I’ve heard reports that this will be done in time, but failing that, Dr. Nancy Lee will act as chairman of the Committee (in place of Dr. Marshall) and the remaining six members will serve. Dr. Lee has the option of extending terms beyond the scheduled expiration date, but we do not yet know if this has been done or if the new members will be sworn in.
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  • Three Minutes for Public Comment – You might recall that we usually have five minutes for public comment. In December, the time was cut to three minutes because of the compression of the agenda due to the snow day. In March, the three minute limit was retained in order to maintain parity with the people who had their time cut in December. But now, the three minute limit appears to be permanent. I originally wondered if this was a mistake, but the OWH confirmed that Dr. Lee decided to keep the three minute limit. Why? I don’t know.

Agenda, On and Off

You can see the full agenda here. There are a few things to note:

What’s on the agenda?

  • A presentation (and recommendations?) from the Research and Clinician-Scientist Recruitment Working Group. I posted about their work to date in April. Group chair Dr. Dane Cook’s term expired in May, so I do not know if he will attend or has been replaced.
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  • Another intriguing topic is “Future Directions” on day two. This is paired with a presentation on epilepsy as a model for collaborating post-IOM report, so I’m assuming that is the focus of the future direction question. This begs the questions of whether HHS will use an IOM report if they don’t like the answer, and the extent to which anybody will be willing to collaborate with anybody else given the controversies over the IOM contract.
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  • Finally, day two will end with “Open forum” among people in attendance. This sounds like open mic, rather than the submit questions in advance process from the past, but I have no information about how this will actually work. I will be very pleasantly surprised if it really is open forum.

What’s off the agenda?

  • An obvious and glaring omission is any discussion of the P2P Workshop, given that controversy. I am hoping/assuming that NIH and AHRQ will address P2P in their agency reports on day one, but each agency only has 20 minutes and there does not appear to be time set aside for questions.
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  • Another omission is the Education Working Group recommendations from the March meeting. Those recommendations have still not been posted to the CFSAC website. Have they been finalized? Submitted to the Secretary? Is there more work to do here?
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  • And finally, there is nothing about charter renewal on the agenda. The CFSAC charter will expire in September. Is renewal a done deal? Is there room for improvement in the charter? We won’t know unless someone takes it upon him/herself to ask the question.

There’s not much time! So sign up for public comment and send it in. Here’s my post from last year about why getting your comments on the record is so important.

 

Will the Real P2P Please Stand Up?

May 19th, 2014 22 comments

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.

 

IOM: Sum of the Whole Matter

May 10th, 2014 12 comments
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.

 

Protocol for Disaster?

May 2nd, 2014 43 comments

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.

 

Don’t Silence Yourself

April 8th, 2014 62 comments

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.