Broken

blackboxMy mother died last night. She was a very private person, which is why I have not spoken publicly about what my family has been through in the last two years.

I was thinking to write about her now, because she was remarkable, but all I can come up with is grief laced with pain and obscenities. And she would not have wanted that. So I will only say this:

My heart is broken. And I may not be around much for awhile.

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CFSAC Meets P2P

Mary Dimmock has been kind enough to provide this post and transcript of the CFS Advisory Committee’s discussion of the P2P report this week.

fistsSince the Executive Summary for the P2P ME/CFS Workshop was published on December 18, 2014, a workgroup of CFSAC has been hard at work to review the report and to draft CFSAC’s official response to that report.

On January 13, 2015, CFSAC met in a two-hour special session to discuss and finalize CFSAC’s comments on the Executive Summary. CFSAC’s comments are to be immediately submitted to the Secretary of Health and then submitted to the P2P Panel before its deadline on Friday, January 16, 2015.

The official version of CFSAC comments will be posted on the CFSAC website but that may not happen by the deadline for P2P comments. In the meantime, here is an unofficial version of the recommendations, produced from an audio file, that captures the recommended changes to the P2P report that were approved by CFSAC.

CFSAC Focused and on Warp Speed

Two things stood out about this CFSAC special meeting. First, this CFSAC meeting was conducted with an unprecedented speed, focus and decisiveness, no doubt due to the obvious work that had gone into drafting the recommendations over the last month. A special thanks to Donna Pearson and all the members of the CFSAC workgroup, including advocates Charmian Proskauer and Claudia Goodell, and to CFSAC itself for making this happen on such a tight timeline. And thank you to Dr. Gary Kaplan for continually calling for CFSAC to insert language about the Canadian Consensus Criteria and the hallmark symptom of PEM. This meeting set a new bar for CFSAC meetings going forward.

But more important are the range and nature of the substantive comments made by CFSAC on the Executive Summary, starting with the complete rejection of the outdated and inappropriate description of the disease as “extreme fatigue and other symptoms that are not improved by rest.” In its place, CFSAC recommended an extensive description of the disease that called out the range of hallmark criteria like PEM and the kinds of dysfunction seen in CCC and ME-ICC (line 2). They also called for the CCC to be universally adopted until updated criteria are accepted (line 365).

Further, CFSAC rejected a number of statements that could be construed to imply psychological causation and rejected further studies of psychosocial parameters and psychological treatments as inappropriate (line 275). Instead, they called for research into a range of biological abnormalities and for clinical trials that included repurposing of drugs currently used in autoimmune, neurodegenerative and viral diseases (line 246).

CFSAC went beyond the Executive Summary’s recommendation to retire the Oxford criteria and also called for studies conducted with Oxford to no longer be used to inform treatment recommendations for this disease (line 365).

CFSAC rejected the P2P Panel’s recommendation to hold a meeting of stakeholders to “reach consensus on the definition and parameters of ME/CFS.” Instead, CFSAC added a recommendation to hold a meeting of stakeholders to “review the results of the study by the Institute of Medicine and to reach consensus on a path forward.” CFSAC explained that its rationale for this recommendation was the need for stakeholders to “review, analyze and or reject the IOM recommendations on this matter” (line 202).

Finally, CFSAC called out the responsibility of HHS and other federal agencies to address the needs of patients (line 80). They included a list of the recommendations that CFSAC has already made, many of which the P2P Panel had included.

Are there other changes that I want to see in the P2P report? Of course there are. For instance, I want to see a specific dollar target set for NIH funding based on the burden of disease – $120M or more. I want to see the entire section on “Improve Treatments” revamped to focus on biological therapies instead of psychosocial therapies. Fortunately, CFSAC did speak to that issue in other sections of the Executive Summary. In order to invigorate the ME/CFS research pipeline, I think that NIH must actively and aggressively address the stigma in academic research centers and NIH’s institutional barriers resulting from this disease being orphaned by every institute. And there needs to be a publicly shared research strategy, not just one internal to NIH, developed with full stakeholder input and driven through objective, published benchmarks to ensure rapid progress. Finally, HHS must actively address the historical lack of urgency and the huge lack of community trust that has built up over time from the historical lack of openness, transparency and inclusiveness and the utter lack of meaningful progress for so many years.

But even so, I think that CFSAC has done a significant service to ME patients in this special meeting. Now it’s up to P2P to listen to these experts and incorporate these changes. Then, HHS needs to finally take some substantial and urgently executed action to fix this mess.

But if CFSAC’s submission does not get translated into the P2P Executive Summary or into HHS action, then at the very least, these comments provide another useful tool for our calls to legislative leaders.

Don’t forget to send in your comments

Some of you have chosen to bypass the P2P Panel and instead communicate your opposition of P2P directly to Secretary Burwell and other leaders. If you plan on doing that and have not yet, this is a great week to do so.

For those who intend to send comments to P2P, don’t forget that the deadline is January 16, 2015 at 11:59 PM EST. If you support what CFSAC had done, let the P2P Panel know. If you see things that are still missing, let the P2P Panel know that as well.

When you send in comments to P2P, remember to note whether you are using the 389 line or the 403 line report and include the line number that your comment refers to. Comments can be sent to prevention@mail.nih.gov. More information is available at this link.

Note: I am collecting P2P comments into a library. You can see the library at this page, and you can send me your comments for inclusion at jspotila AT yahoo DOT com.

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P2P Library Now Available

As I promised in my previous post, I have created a library of public comments submitted to NIH on the P2P Panel’s draft report. You can view links to each comment on this page.

I will update the page with more comments as I receive them. If you would like to add your comment to the library, please email it to me at jspotila AT yahoo DOT com. Let me know if you would like to be anonymous.

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P2P Obstacles

obstaclesAhead

Are you working on your comments on the P2P Panel’s Draft Report? I hope so! Unfortunately, the Office of Disease Prevention (ODP) has taken several actions that create barriers in the commenting process. I have details, and I suggest several work arounds for these new obstacles.

Line Numbers

Yesterday, advocate Anne O brought to my attention that there were two different versions of the P2P Panel’s report in circulation. The first version, published on December 18th, is 403 lines long. The version currently posted on the ODP website is 389 lines long. I did a line by line comparison, and there are no differences between the texts. But beginning at line 212, the formatting and line numbers diverge.

This is a problem because NIH has asked the public to refer to line numbers in making comments. As an example, in the first report lines 340-349 refer to the recommendation to create collaborative centers, but in the second report those lines cover the recommendation to conduct clinical trials and the beginning of the recommendation on improving treatment. If a comment simply refers to line 340, how will the Panel know which line 340 is meant?

An advocate alerted ODP to the problem, and was told that the Panel had been informed of the “formatting error,” and was devising a way to ensure that comments referring to specific lines are attributed correctly. I assume this means one or more people will have the laborious task of determining which version of the report each commenter used. One hopes the reconciliation will be done correctly, because otherwise it will be very difficult for the Panel to understand the public comments.

Here’s the thing about this “formatting error.” If my husband did something like this in his private sector job, he would be fired. And I can tell you that as an attorney, the first thing I would do before posting a second version of a report would be to check that the line numbers are the same, especially if I had asked people to use line numbers in commenting!

It is pretty simple to verify that your reformatting has not changed line numbers. But that wasn’t done here. Why? Carelessness or incompetence? Or a more nefarious attempt to make public commenting difficult for a patient population with significant cognitive challenges? If NIH or HHS wonders why some people believe there is a conspiracy against ME/CFS patients and researchers, this is the kind of thing that reinforces and supports that belief. After all, we are consistently told that violations of the Federal Advisory Committee Act by the CFS Advisory Committee are errors and contractor problems, even in the face of proof that the violations were intentionally made. This is the latest in a long list of blunders that create the impression that HHS is incompetent, or does not care, or intentionally acts against us.

Mistakes happen. I make them all the time. Do you know the best way to deal with mistakes? Admit them, then fix them. As soon as NIH discovered the formatting error, they should have offered an explanation and a way to address it. And if NIH didn’t realize there was a problem until we brought it to their attention yesterday, then they should apologize for the mistake and inattention to detail.

Work Around: Since we don’t know what the “system” for reconciling comments will be, I recommend that you begin your comments by noting whether you are using the 403-line or 389-line version. If you can, you might also want to quote a few words from the line in the body of your comments, e.g. “Line 350-351: “Establish a central archive of de-identified data . . .”

Comment Retention

When CFSAC or FDA have collected public comments, including comments on written reports, those comments have been preserved in the public record. However, Wally on Phoenix Rising has discovered that ODP does not intend to preserve the public comments on the P2P report. Wally was told, “Public comments are forwarded to the panel and are not retained.”

Several advocates have looked into whether this is legal. It appears that NIH is taking advantage of a gap between the Administrative Procedures Act and the Paperwork Reduction Act. How to collect and preserve public comments on a report like this appears to be within the agency’s discretion, and NIH is exploiting this.

This is ridiculous. The P2P process is conducted by a federal agency, and is tax-payer funded. The process is administered by federal employees and government contractors. The report was published on an agency website, and comments were requested by the agency. The agency will collect those comments, and then provide them to the Panel whose members are selected by the agency. This is a completely federal exercise, funded by the tax payers.

How is it acceptable for NIH not to retain the comments? How is it in NIH’s interest not to do so? There will be no transparency or accountability for the final P2P report, because there will be no way for the public to examine how the comments impacted the report. In contrast, AHRQ will publish all the comments received on the draft systematic evidence review along with how each comment was disposed of in the final version (accepted, rejected, etc). The Institute of Medicine is required to not only retain public comment but provide it upon request (for a fee). But NIH can’t be bothered to hang on to comments on the P2P report?

Several members of Congress have been alerted to this situation, and I will address it in my CFSAC comments next week. In the meantime, I would like to suggest a work around: send me a copy of your comments on the P2P report and I will create a public library of all the comments. This will preserve them and give us at least a partial window into the feedback the Panel receives. Email your comments to me at jspotila AT yahoo DOT com.

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This Year

let goI’m not one for New Year’s resolutions. You make a plan or you don’t. You execute it or you don’t. Shit happens, and all you can really control is how you respond. But this New Year’s wish from Neil Gaiman struck me as particularly appropriate, at least for what my 2015 may be. The full post is here, but this is the wish that Gaiman wrote for 2015:

Be kind to yourself in the year ahead.

Remember to forgive yourself, and to forgive others. It’s too easy to be outraged these days, so much harder to change things, to reach out, to understand.

Try to make your time matter: minutes and hours and days and weeks can blow away like dead leaves, with nothing to show but time you spent not quite ever doing things, or time you spent waiting to begin.

Meet new people and talk to them. Make new things and show them to people who might enjoy them.

Hug too much. Smile too much. And, when you can, love.

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Laura Hillenbrand is Not Your Bitch*

Laura Hillenbrand is a New York Times best selling author, and one of the most prominent public figures to speak out about having ME/CFS. She has donated hundreds of thousands of dollars to ME/CFS research, has discussed her struggles with the disease in a hundreds of interviews, and spent a year writing the award winning essay “A Sudden Illness,” which remains one of the best descriptions of ME/CFS I have ever read.

Which is why recent criticism of Laura Hillenbrand and her “failures” in advocacy makes me so angry.

Over the past several months, I’ve heard advocates saying that Laura should use the premiere of Unbroken to raise money for ME/CFS research. Advocates have suggested that she assign her “people” to conduct a public-awareness campaign about ME/CFS by leveraging coverage of the movie. And after the NBC/Tom Brokaw special about the film did not mention the name of Laura’s disease, criticism from advocates became more vocal and more pointed.

I asked Laura why the disease name was not included in the Brokaw special. She told me that she had actually discussed the disease extensively with Brokaw during their two-hour interview. Brokaw and the NBC staff were “immensely considerate about my illness and respectful of my limitations.” When she was given a preview of the script, she even took the time to explain to the fact-checker why the name ME is preferable to CFS. Ultimately, the disease name did not make it into the final version, but that is something beyond Laura’s control. The focus of the program was the film and Louie Zamperini’s story.

Laura’s work to bring public attention to this disease is evident in the New York Times profile article published last week. In extensive interviews with Wil S. Hylton, Laura described the details about living with ME/CFS and her resulting disability. The effects of the disease on her work and her writing process will leave no doubt in readers’ minds about the seriousness of ME/CFS.

Advocates consistently say that we need a celebrity spokesperson, like Michael J. Fox has been for Parkinson’s. But it is not easy to be public about having ME/CFS. Many people with this disease, not only celebrities, stay silent about it because of the stigma and because of everything that comes with being public about poor health. I’ve had people ask me if I’ve tried acupuncture, antivirals, homeopathy, immune modulators, meditation, Ampligen, positive thinking, exercise, weird diets, a warmer climate, or faith healing. I’ve had people criticize me for how I manage my disease and what I say about it. I find it difficult to deal with these sorts of questions and criticisms on the small scale of a personal blog. It’s hard to imagine what it would be like to deal with it from thousands of people like Laura does.

To all the advocates who have criticized Laura for not doing enough, let me be perfectly clear: Laura Hillenbrand is not your bitch. She does not work for you. She has no obligation to you.

Laura’s courage in speaking out has brought more mainstream attention to this disease and its impact on individual lives than anything else in the last ten years. Recognize that while Laura speaks the truth about her life with ME/CFS, this does not guarantee the media will use everything she says.  That she has chosen to be so public about having ME/CFS is a gift to all of us. Perhaps we should say thank you, instead of insisting she owes us even more.

*Title inspired by a blog post by Neil Gaiman, in which he pointed out: “George R.R. Martin is Not Your Bitch.”

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P2P Report: First Read

The P2P Panel’s draft report on advancing ME/CFS research has been published. The report is not the nightmare that many people feared, but it is also not what I had hoped for or what we need.

The advocacy chatter I’ve seen in the last 12 hours (and I have not seen everything) has been overwhelmingly positive. Words like “superb” and “justice” have been used, and it is true that there is much in the report that validates what ME/CFS experts and advocates have been saying for years.

I am in the “bah, humbug” minority, though. While there are strong recommendations in the report, many things that I considered essential for success are missing.  For example, the Panel does not seem to have understood post-exertional malaise, how it is distinguishable from fatigue, and the data that show how essential it is to understanding this disease. I don’t blame the Panel for this oversight, necessarily. Given the evidence review and the agenda of the Workshop, they were not presented with much of that data. This is the Achilles heel I’ve been pointing to all year: that the Panel would not be shown the full ME/CFS landscape and therefore, their attempt to chart a course through that landscape would suffer.

There are a number of ME/CFS advocates who believe that NIH does not want to fund research on this disease. Setting aside whether that is true and the accuracy of the alleged reasons for it, the draft Panel report will not solve the problem. Perhaps it’s my legal training, but when I read this draft report I see so many loopholes. If I were NIH and I did not want to increase funding for ME/CFS research or change the institutional approaches to the disease, then I would scan this report looking for ways to continue that policy. I would look for recommendations that I could accomplish at little or no cost, and I would focus on those. Then I could report to the CFS Advisory Committee or Congress that I was making tremendous progress on the recommendations, without actually changing the basic fundamental problem: grossly inadequate funding that is disproportionate to the burden of ME/CFS. From that point of view, this draft report offers many opportunities that NIH could exploit.

I won’t be able to post more detailed comments until after the holidays, but that is where you come in, too. We have until January 16, 2015 to submit comments on the draft report to NIH. After that, the Panel will review all the comments and finalize the report. Instructions for submitting comments are here, and be sure to follow those instructions when you comment.

To the extent that the Panel got things right, it is a direct result of the participation of ME/CFS experts and advocates. The draft evidence review was a disaster, and some of the Workshop presentations fell short. If you watched the Workshop, then you will recognize its impact on the draft. For example, Dr. Hornig’s presentation on the microbiome was obviously persuasive to the Panel. And the patients who spoke at the meeting or submitted comments online were the only source of information for the Panel on the devastating impact of this disease.

If you want NIH to carry on as it has thus far or if you think this report is superb as it is, then you may not see a need to comment. But if you see any flaws in this report, or loopholes that will perpetuate what has been done (and not done) for decades, then you MUST comment on the report. If you think this whole process is illegitimate, or you think the Panel should be recommending adoption of the Canadian Criteria, then submit comments on the report. That is the only way you will be heard by the Panel.

We’ve already seen the impact that the experts and advocates have had thus far by speaking out. Please join us, and tell the Panel what you think of this report.

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P2P: Eating Your Cake

OxfordIn a surprising move at the P2P Workshop yesterday, Dr. Beth Smith from the Evidence Practice Center (authors of the systematic evidence review) suggested: “Consider retiring the Oxford case definition.”

Why was this remarkable? Because the systematic evidence review had included Oxford studies, despite acknowledging that the definition may include people who do not have ME/CFS. Perhaps the Evidence Practice Center heard the well-supported criticisms from myself and others, because in revising their report they said: “Treatment trials . . . should refrain from using the Oxford case definition because it is less specific for ME/CFS than the other definitions are.”

But when I asked a question about the suggestion to abandon Oxford . . . well, here is what I said:

I would like to go back to Dr. Smith’s suggestion that the Oxford definition should be retired. The evidence review rated at least one Oxford study, the PACE trial, as good quality. And Dr. Snell quoted from the PACE trial manual about the assumptions behind CBT and GET treatments and the inappropriate patient selection in those types of studies.

So as a former attorney, I hope you will forgive my leading question: If the Oxford definition should be retired – and it should – doesn’t that lead to the obvious conclusion that Oxford studies should also be retired, at least as applicable to the ME/CFS population?

Dr. Smith’s answer was not quite logical. After reminding me that a “good” rating refers to methodology and not the possibility that a study was biased, she said that it was still good to cast a broad net in designing studies.

The Evidence Practice Center (and perhaps AHRQ and NIH?) cannot have its cake and eat it too. If Oxford captures people without this disease, then you CANNOT use Oxford studies to draw conclusions about people with this disease. It makes no sense to say the definition is flawed, and that it should not be used in future treatment trials, and then try to grip the Oxford studies in your sticky fingers by saying it’s good to cast a broad net.

The first step in designing a treatment trial or other study is to Define. Your. Study. Subjects. Define them clearly and accurately. It goes without saying that if you want to study a disease treatment, then you should study people with the disease.

Science moves on. That’s its purpose. Science is iterative, and as data are accumulated and advances are made, methods and approaches change, too. If the Oxford definition should be retired because the data show that it is inaccurate and flawed in describing people with ME/CFS, then all the data derived from using that flawed definition are suspect.

Chris Heppner was quite prescient in urging us to declare independence from the Oxford definition. Perhaps the P2P Panel will have the logic and common sense to do so, too.

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The Oxford Problem

Today, I’m very pleased to share this guest post by Chris Heppner.

declaration-of-independenceI loved Oxford when there as undergraduate (1951-4)–truly a city of dreaming spires, peaceful libraries, walks in the country to a lovely old pub by a waterfall with peacocks in the gardens–a great place on a warm summer evening. Et in Arcadia Ego–a Greek pastoral on a quiet English river. But I now invite you to join me in declaring independence from a very different Oxford that appeared many years later.

In 1990 a group of doctors, Dr. P.D. White and Dr. S. Wessely prominently among them, met to create a new research definition for what was then called Myalgic Encephalomyelitis in England. They did this because there were then current several definitions, which they alleged caused “Contradictory findings… largely because research has been carried out by investigators trained in different disciplines, using different criteria to define the condition. … A number of clinical syndromes have been described…but differing sufficiently to preclude comparison of published studies.” (“A report-chronic fatigue syndrome: guidelines for research,” Journal of the Royal Society of Medicine, Vol.84, Feb.1991, p.118). The group were set upon changing this situation, and the result was this paper, henceforth called “the Oxford definition.” The undeclared strategy would seem to have been to widen the accepting mouth enough to swallow all the rival definitions–one ring to rule them all (yes, Tolkien was a Professor at Oxford while I was there).

From our perspective, however, the inclusion of studies done under the Oxford definition over the past 23 years, with its rejection of post-exertional malaise as a requirement and its permissive inclusion of depression, has confused attempts to grapple with the dimensions and nature of our disease. In fact, much has been lost– Ramsay and various other researchers had, by 1990 or so, already grasped some key aspects of our disease, which were then swamped by the imperialistic energy and funding available to the psychiatric lobby.

Let us take a close look at this beast. It demands only one “symptom,” prolonged fatigue, which is carefully defined in the Glossary that forms a key part of the document as merely a “subjective sensation,” which is EXPLICITLY not “to be confused with impairment of performance as measured by physiological or psychological testing. The physiological definition of fatigue is of a failure to sustain muscle force or power output.” There may be other “symptoms,” such as “Mood disturbance,” “Myalgia,” Sleep disturbances,” but “fatigue” is the principal and only required “symptom.”

However, there are now (but as the followers of this definition insist on ignoring), multiple trials showing very clearly that we do indeed suffer from “a failure to sustain muscle force or power output.” Our miserable performance on day 2 of a 2 day VO2Max test reveals this vividly–and painfully, as a reading of Jennifer Spotila’s blog on her test will convince. The work by Snell and Stevens has now been replicated by others such as Betsy Keller. We have multiple studies showing vividly the physiological results of even one shot exercise–Julia Newton’s work showing our inability to clear lactic acid build-up in our muscles, cytokine and gene expression studies from various sources, especially the Lights, showing a morbid response to exercise quite different from that of a healthy, or indeed depressed, person. We do not have the mere “symptom” of a “subjective sensation” of fatigue–we have the real thing, with multiple physiological “signs”–a very different word from “symptom” in the vocabulary of this definition. Just exactly what these “signs” indicate by way of etiology and treatment remains to be elucidated, but they are objective, not subjective. We have not only fatigue, but also PEM, and we have it in spades. And our fatigue can be clearly distinguished from the fatigue caused by heart failure, MS, and most other fatiguing conditions.

There is another dimension to fatigue as defined here: “Mental fatigue is a subjective sensation characterized by lack of motivation and of alertness”–and, to repeat, “The symptom of fatigue should not be confused with impairment of performance as measured by physiological or psychological testing.” Here too we now have a fair number of studies; and a very interesting talk by Dane B. Cook on an ongoing, not yet published study, showing exactly that–impairment of aspects of cognitive performance under the stress of fatigue inducing exercise, in such areas as multiple tasking etc. We do not belong inside the Oxford definition.

Another feature of the Oxford definition is the list of exclusionary conditions, which includes “proven organic brain disease.” Once again we now have multiple studies that show things like white spots similar to those in MS, brain hypoperfusion made worse by exercise, and very recently the Stanford study proving brain abnormalities by highly sophisticated imaging techniques; we do indeed have “proven organic brain disease.” On this ground too we are excluded from studies using the Oxford definition, and it is the definition itself that says so.

How do NIH and the AHRQ draft handle the Oxford Definition?

A partial answer seems to be that NIH is permissive, though that may change when results come in from the IOM and P2P projects. We still have multiple definitions, “differing sufficiently to preclude comparison of published studies,” but the NIH appears to find this a good thing. Dr. Shirley told Medscape Medical News that “Multiple case definitions for ME/CFS have been developed to meet clinical and research needs. NIH encourages researchers to use the case definition that best meets their needs for rigorous scientific exploration of the …underlying pathology…” Let a thousand flowers bloom. It seems that in their view multiple case definitions are just fine, including the definition that explicitly excludes all of us who have measurable impairment of physical or cognitive performance.

The AHRQ systematic evidence review commissioned by the NIH for their P2P workshop did the same thing, despite expressing concerns about the Oxford definition. The Executive Summary admits that “Experts consider post-exertional malaise (PEM) and memory or concentration problems critical components.” They return to the issue in the Discussion: “Multiple case definitions have been used to define ME/CFS and those that require the symptoms of PEM and neurological and autonomic manifestations appear to represent a smaller but more involved subset of the broader population.” Right: in fact, they almost stumble into an admission that ME as defined in, say, the Canadian Consensus Criteria, represents a different population than the general simply fatigued and/or depressed populations included by the Oxford.

The review goes on to admit “We elected to include trials using any predefined case definition but recognizing that some of the earlier criteria, particularly the Oxford …, could include patients with 6 months of unexplained fatigue and no other features of ME/CFS. This has the potential of inappropriately including patients that would not otherwise be diagnosed with ME/CFS and may provide misleading results.”

I find this decision to “include trials using any predefined case definition” in spite of the problems identified quite extraordinary; good evidence is provided that some definitions, and in particular the Oxford, probably include patients who do not have the disease being considered for a new definition, that such inclusion will probably skew the results–and then they go ahead and include them anyway.

And not only include them, but make interventions crafted specifically for them into the key recommendation for treatment, albeit with some reservation. The Conclusions to the Discussion section of the AHRQ draft say this: ”Multiple case definitions for ME/CFS exist with those that require symptoms of PEM, neurological impairment, and autonomic dysfunction representing a more severe form of the condition….. Although CBT and GET have shown benefit in some measures of fatigue, function and global improvement…GET appears to be associated with harms in some patients….” They note a problem, but again draw back from the obvious conclusion–that GET will make most patients who genuinely have ME worse, not better, unless they wisely withdraw from the study–the high rate of withdrawal from most studies using GET, most of which are done under the Oxford definition is noted, but again the clear implications are avoided. This was not only unwise, but the review will serve to perpetuate the erroneous application of Oxford based studies to ME patients who may be harmed by them.

It is abundantly clear that this systematic evidence review, unless drastically revised, cannot form the basis for a helpful refinement of the diagnosis and treatment of our disease–call it what you will. Maybe the IOM and/or the P2P will produce a new definition that will please nearly all stakeholders, and allow us to forget bitter feelings aroused when the HHS rejected the request from 50 of the top researchers in the field to accept and use henceforth the CCC definition.

But I propose a Declaration of Independence from the Oxford Definition, as follows:

A Declaration of Independence:

1) Whereas the current use of multiple definitions has had the effect of drowning out the evidence that shows the serious condition of most patients who have ME according to more specific definitions;

2) And whereas the Oxford definition demands only one “symptom,” prolonged fatigue, which is carefully defined in the Glossary as a “subjective sensation” which is explicitly not “to be confused with impairment of performance as measured by physiological or psychological testing. The physiological definition of fatigue is of a failure to sustain muscle force or power output.”

3) And whereas there are now many published studies showing from various perspectives both a physiological inability to “maintain muscle force or power output” and also impairment of cognitive performance accompanied by dysfunction visible on proper scanning;

4) And whereas the list of “exclusionary conditions” lists “organic brain disease,” and evidence is is accumulating of such signs as white spots, brain hypoperfusion, and brain dysfunction;

We therefore declare that the claimed results of studies done under the Oxford definition cannot be represented or interpreted as addressing patients with ME, but only as covering patients with unexplained fatigue that may legitimately be interpreted as “subjective sensations.”

We sufferers from ME further declare that the Oxford definition be interpreted as written: that it explicitly excludes us from participation in both studies done under its name, and from reviews that include such studies. We request relief from the suffering that has been inflicted upon us by this careless and erroneous practice.

Oxford, besides its dreaming spires, has also been known as the “last home of lost causes,” and the tag “Et in Arcadia Ego” has been also interpreted as meaning “I, death, am to be found even in Arcadia,” as in Poussin’s painting. Oxford has been death to us—we demand to be freed from its control.

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CFSAC: Stand Up for Your Work

I delivered this public comment by telephone at the December 3, 2014 CFS Advisory Committee meeting.

This committee’s legitimacy is at stake. Nine months ago, your March meeting recommendations were substantially altered after your public vote. Documentary evidence that I obtained through FOIA suggests that Dr. Nancy Lee and Dr. Gailen Marshall did this together. Three months ago, I brought this brazen violation of federal law to Dr. Levine’s attention, and two months ago I asked the General Counsel to intervene.

Two days ago, Dr. Lee informed me that your correct and legal recommendations have still not been sent to the Secretary. She said that Secretary Burwell wants to receive your recommendations along with the agencies’ responses to them, and that it will take yet more time to formulate responses to your nine-month old recommendations. Now, this does not make much sense to me. The communication becomes more of an informational memo if the agency responses are given to the Secretary at the same time she receives your recommendations.

The real question, though, is why is the work of this committee repeatedly undermined by HHS staff? It can’t be fear, because if the Designated Federal Officer does not like your recommendations, she may simply violate the Federal Advisory Committee Act and change them. And after getting caught? She will simply drag her feet and take months to getting around to fixing the situation that she created in the first place, with no apparent consequences.

This contempt and disdain is not limited to you, of course. ME/CFS advocates are so irrelevant that HHS does not bother to provide you with our written testimony with even 24 hours to review it in advance of your meetings – another FACA violation that I was promised, in writing, would be remedied. Indeed, the FACA violations are stacking up like cordwood at this point. One legal expert I consulted could only describe this situation as “bizarre.”

This committee is on the verge of allowing itself to be turned into window dressing and a rubber stamp. Why should advocates spend precious energy writing testimony if you can’t read it before your meetings? And why should you invest so much time in working groups and crafting recommendations, if the DFO can change what she or HHS doesn’t like?

CFSAC members, you must stand up and defend the integrity of your work. I still believe this committee can make a positive difference in federal policies and in the lives of ME/CFS patients. But that starts with you. I am one disabled person, and you can surely do so much more than me. ME/CFS patients and advocates need you to fight for us. Please don’t let your work and this Committee be eviscerated any further. I hope we can count on you.

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