PEM Differential

diagnosisstampOne of the post-IOM controversies consuming advocates at the moment is the concern that SEID criteria are non-specific and will include people who do not have our disease. The failure to list exclusionary conditions, including psychological disorders, has drawn criticism from some advocates and at least one expert clinician. This is a legitimate concern because if the SEID criteria capture people who do not actually have it, then we are simply perpetuating the problems with the Oxford and Fukuda definitions, both of which have been demonstrated to include people who have fatigue that is not caused by our distinct disease. But will the SEID criteria open the floodgates to people who have only depression or anxiety or other fatiguing illnesses? The answer is no, if the SEID criteria are correctly applied.

Correct diagnosis is critical for clinical care and research. Overly broad groups of subjects can produce misleading research results, and incorrect diagnoses harm patients. For years, advocates and experts alike have pointed to post-exertional malaise as the symptom that distinguishes our disease from other fatiguing illnesses. PEM was a focus of the Voice of the Patient report from FDA, and is also one of the core symptoms identified by Dr. Leonard Jason’s research as essential for diagnosis. The IOM agreed, and made PEM mandatory for diagnosis with SEID.

The IOM report described PEM as:

worsening of a patient’s symptoms and function after exposure to physical or cognitive stressors that were normally tolerated before disease onset. Subjective reports of PEM and prolonged recovery are supported by objective evidence, including failure to normally reproduce exercise test results (2-day CPET) and impaired cognitive function. These objective indices track strongly with the presence, severity, and duration of PEM. (p. 86)

The IOM also found PEM to be a characteristic symptom of ME/CFS:

The existence of PEM can help physicians confirm a diagnosis of ME/CFS earlier rather than only after extensive exclusion of other conditions. Several studies have found that PEM best distinguishes ME/CFS from idiopathic chronic fatigue and may help distinguish it from other fatiguing conditions with a lower frequency of PEM. (p. 85-86)

The IOM report cites several papers finding PEM in major depressive disorder and multiple sclerosis, but interpreted them with caution because the prevalence of PEM depends on how it is defined and assessed. If these papers did not define PEM as the exacerbation of multiple symptoms after physical or cognitive exertion, then the findings would not be applicable given how IOM defined PEM.

Unlike the Canadian and International Consensus Criteria, the IOM lists no exclusionary conditions. Many people seem to have interpreted this to automatically mean the criteria are too broad. But the IOM explained that people can have SEID and other diseases, whether it is obesity, hypothyroidism, or cancer. Under Fukuda, any of those diseases would preclude diagnosis with CFS, but comorbidities are a fact of life.

For example, I have obstructive sleep apnea that arose after my diagnosis under Fukuda. Technically, this should disqualify me from diagnosis under those criteria. However, my sleep apnea is perfectly controlled by use of a CPAP machine. The data from the machine show that I do not have sleep apnea when I am using the machine (which I do, every single night). Yet I am still sick. So why should having sleep apnea, especially if it is well-controlled, exclude me from diagnosis? Certainly, the sleep apnea should be taken into account if I participate in a research study, and could possibly disqualify me from some studies. But it should not exclude me from diagnosis with the disease.

The same is true of other comorbidities. Why should someone with hypothyroidism which is being adequately treated be denied diagnosis with SEID if they have PEM, sleep problems and cognitive dysfunction? If someone has PEM, severe fatigue that prevents them from working, unrefreshing sleep and orthostatic intolerance, what difference does it make if they also have depression? Doesn’t that person deserve treatment for depression as well as management of SEID?

In my opinion, comorbidities are not the concern. The legitimate concern is whether SEID would, like Oxford and Fukuda, be applied to patients who have only depression or only anxiety (or only other fatiguing illnesses). Research has shown that Oxford and Fukuda both erroneously include people with “just” depression (and I do not mean to minimize the suffering of depression) and not the distinct disease described by ME or SEID criteria. This would be a fatal flaw of SEID criteria, because we know that studies like PACE have included high numbers of people with fatigue but not our disease, and this could account for the small signal of CBT and GET effectiveness reported in PACE (notwithstanding all the other legitimate criticisms of how PACE was conducted and analyzed).

But unlike Oxford and Fukuda, SEID requires the hallmark characteristic of PEM. If post-exertional malaise is unique to our illness, then correctly applied SEID criteria should not misdiagnosis people with other fatiguing illnesses as having SEID. Why? Because if a patient does not have PEM, they would not be diagnosed with SEID. And if a person has PEM and the other core SEID symptoms, then they have our disease regardless of what other conditions they may have. Therefore, if a person has only clinical depression or only hypothyroidism or only multiple sclerosis, that person does not qualify for SEID because he/she would not have PEM and the other core symptoms.

The IOM committee is staking the position that PEM is so distinct that no differential diagnosis is required, because differential diagnoses are needed only when multiple diseases present with similar symptoms. Once a clinician has established that a patient not only has severe debilitating fatigue, but also has PEM, unrefreshing sleep, and cognitive dysfunction and/or orthostatic intolerance, there is no need to exclude other conditions. This is a distinct symptom presentation, and will not – if correctly applied – result in people who do not have the disease being included in the patient population. Remember that Dr. Jason’s research identified PEM, unrefreshing sleep and cognitive dysfunction as the core symptoms of the disease, especially when frequency and severity cutoffs are applied (as IOM also recommended).

The real issue, in my mind, is whether these criteria will be correctly applied. Chapter 7 of the IOM report and the materials for clinicians both include questions and tests to determine if a person has PEM. However, given the misinformation already extant about our disease, and the outright prejudice among some in the medical profession, we cannot take it as a given that healthcare professionals will suddenly be able to recognize PEM correctly. That is why the educational recommendations of the IOM report are so critical, and why I believe we should be vigilant about whatever materials HHS ends up creating as part of an education campaign. It is unquestionable that many healthcare professionals need remedial education, and CDC’s current education materials are grossly inadequate. But this is a different problem from the fear that the SEID criteria themselves are not sufficiently specific to exclude those who do not have the disease.

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Your Move, HHS

chessSince the IOM report came out, the patient/advocate online community has been on fire. Everyone is staking out a position. You like the name, or you don’t; you think the definition will work, or it won’t. And I have plenty to say about these issues, too. But what I don’t hear people asking is: what is HHS going to do with this IOM report?

HHS itself has made a single, bland statement. Dr. Nancy Lee said on the CFSAC listserv that, “We are committed to working with our Federal partners, stakeholders, and experts in the field, as well as with the HHS Chronic Fatigue Syndrome Advisory Committee, to review the report’s recommendations and appropriate next steps.”

That’s inside-the-beltway-speak for “we’ll get back to you.”

Remember that HHS received the report at least a week before it’s public release. Remember that the sponsoring agencies received a briefing from the IOM committee about the report, and Dr. Clayton said they were “breathtakingly clear” about their recommendations. I realize that government moves slowly, and there will probably be meetings and actions proposed and approvals sought and so on. But the patient population is reading and discussing the report in public (as well as in private), and I think we all know that HHS monitors the blogs and forums. So we are telegraphing our analyses, controversies, and plans to HHS while they remain silent.

But we need to know what HHS thinks and what HHS is going to do. Fellow advocates, we really need to know this because we must shape our own advocacy to push the right levers and get the results we want. Here are some of the questions I’m thinking about:

  • Will CDC accept the SEID definition, especially the requirement of post-exertional malaise? CDC has refused to make PEM a requirement for years.
  • Will CDC use the name SEID, but simply lay it on the Empirical or Fukuda definition? This would be disastrous for us.
  • Will CDC take down its Toolkit, and put a properly revised one in its place? Advocates have been battling with CDC to remove the recommendation for GET for years.
  • Will HHS appoint an SEID czar, as IOM recommended, to oversee the dissemination of the new name and criteria?
  • Will the National Center for Health Statistics create a new diagnostic code for SEID? Who will be charged with writing that proposal and seeing it through?
  • Will FDA adopt SEID as required criteria? Thus far, FDA has been agnostic on the case definition and said it will accept definitions specified by sponsors. But if FDA were to focus on SEID, that might require sponsors to reanalyze their data to examine participants who meet SEID criteria.
  • Is NIH giving the P2P Panel a chance to revise their recommendations in light of the IOM report? For example, the draft P2P report recommended, “that the ME/CFS community agree on a single case definition (even if it is not perfect).” Does the P2P Panel think that SEID meets that need?
  • And the $100 million question: Will NIH finally step up and provide the funding we need to effectively research this disease?

The answers to these (and other questions) should shape our advocacy. To that end, I faxed a letter to my Congressmen today asking them to find out what HHS intends to do about the IOM recommendations. You can see the text of my letter here, and I urge you to send a similar letter to your own Congressmen as soon as possible.

The advocacy debates will continue to rage for many weeks. In the meantime, it’s your move, HHS. You commissioned this report for $1 million. How will you put its recommendations into practice?

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NPR Interview

Miriam Tucker has been covering ME/CFS for some time now, and published a great piece for NPR about the IOM report today. I was interviewed for the piece, and I can say that Miriam understands this disease, much like David Tuller and some of the other journalists who have covered the topic.

The reality of journalism – even online journalism – is that word count matters. Miriam’s piece came in at about 800 words, not much room to cover the complex issues arising from the IOM report. And I tend to be a wordy person, so I’ve posted my complete email interview with Miriam from yesterday.


Miriam, I haven’t had a chance to review the report yet, so my reaction is based on the briefing documents and the event today. I also posted a quick blog post.

What do I think of the criteria?
I think the IOM Panel got a lot of things right with the new criteria. They focused on the central feature of the disease, post-exertional malaise, and limited the required symptoms to a short list. They also make recommendations on frequency and severity, which Dr. Jason’s work has shown is essential. Finally, it appears that this diagnosis is no longer a process of exclusion, as CDC and other entities have insisted for decades. When I was diagnosed, my doctors focused on ruling things out, and CFS was the diagnosis of last resort after everything else was eliminated. Now if you meet these criteria, you have this disease. That is a huge shift, and I’m not sure if people have really keyed in on that yet.

What do I think of the name?
SEID will be controversial, especially for the advocates like myself who argued for use of the term myalgic encephalomyelitis. The name does two things right – it focuses on the key symptom of PEM, and it uses the word “disease” which is very important. However, I think this is a risky change. It could take a long time to secure a diagnostic code, and it’s not clear who will be responsible for making that proposal. Another concern is that the name change will be made, but not the definition change. In other words, if CDC simply renames the disease to SEID but does not actually shift to the new criteria, then we are no further ahead. The name and criteria should be used together to make a clean break from the diagnostic waste basket of CFS.

What do I like/what done better?
I would like to see data that support SEID as a better name than ME.

Will it help patients?
That all depends on how widely and how accurately the criteria are implemented. Again, the name and criteria should be used as a clean break and not simply replacing CFS with SEID.

What do I want to have happen next?
I want to hear from HHS. So far, the only statement I have seen is the one from Dr. Nancy Lee that I’ve copied below [NB: the statement went out on the CFSAC listserv on February 10]. That is a non-statement as far as I’m concerned. I want to know if CDC will adopt these criteria, and accept PEM as mandatory for diagnosis. I want to know if CDC and HRSA will roll out the material for clinicians. And the most important issue of all: will NIH actually invest the research dollars necessary to understand and treat this disease? Without a substantial and meaningful increase in research funding, all these other issues will be meaningless.

Statement from Nancy C. Lee, MD, Deputy Assistant Secretary for Health – Women’s Health and Director of the HHS Office on Women’s Health:

The HHS Office on Women’s Health and the other sponsoring agencies* want to thank the Institute of Medicine (IOM) Committee on Diagnostic Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) for its thoughtful analysis in developing this important report. We are pleased with the committee’s recognition of the impact that ME/CFS has on the lives of many Americans. With their recommendation of a streamlined, yet evidence-based set of diagnostic criteria, the IOM committee has taken a critical step toward assisting medical providers in making a diagnosis for those with this serious and debilitating illness.

We are committed to working with our Federal partners, stakeholders, and experts in the field, as well as with the HHS Chronic Fatigue Syndrome Advisory Committee, to review the report’s recommendations and appropriate next steps.

*The Agency for Health Care Research; the Centers for Disease Control and Prevention; the Food and Drug Administration; the National Institutes of Health; and the Social Security Administration.

The report can be found at the following link:

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IOM: Report Card

It’s here. A new case definition and a new name. It will take some time for me to get through the 300 page report and prepare a more detailed analysis. But based on the press conference and summary, how did the report stack up to my criteria for success?

Post-exertional malaise: This was my drop dead deal-breaker, and the new definition makes PEM the central feature of the disease. Dr. Clayton said that PEM was “the essence of this disorder,” and it is required for diagnosis.

Core features: As I had hoped, the new definition requires only four symptoms for diagnosis: a substantial decrease in function (work, school, social); PEM; unrefreshing sleep; and cognitive dysfunction and/or orthostatic intolerance. These core symptoms also match what Dr. Lenny Jason’s work has shown. At the press conference, Drs. Clayton, Bateman and Rowe all emphasized that this is an evidence-based definition.

Frequency/Severity: Another requirement I was hoping to see. The new definition requires symptoms “persist for at least 6 months and be present at least half the time with moderate, substantial, or severe intensity.”

Name: CFS is out, but so is ME. Citing a need to focus on the key feature of the disease, the committee proposes Systemic Exertion Intolerance Disease. Um, what? Dr. Lenny Jason told David Tuller that the patient community will not like or accept this name. I think he’s probably right about that.

Making the diagnosis: As I hoped, the report provides guidance on how to make the diagnosis, with an algorithm, short list of tests, and clinician materials to be published soon.The committee insists that any healthcare provider can make this diagnosis and start treating patients. I want to read more in the report about how they think this is possible, given the radical under diagnosis we currently face.

No psych: Dr. Clayton was emphatic at the press conference that this disease is not somatization. I’ll be reading the report carefully to see how they address the psychosocial theory.

Where To Next: This is the BIG question. Will HHS accept this name and definition? Who will submit the proposal to create a new code in ICD-10, and what category should it lodge in? Will the name CFS simply be replaced with SEID, without refining the research cohort selection?

Dr. Clayton said that this report gives advocates the “fodder” to “act up.” Will we? Can we find a way to pull together and use the good parts of this report to advance the cause? That is the question that will keep me up tonight.

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IOM: The Big Day

IOMOn February 10th, the Institute of Medicine committee will release its report Beyond ME/CFS: Redefining an Illness. The release event will be webcast at 11am Eastern. The report contents are under embargo until the release, although rumors are flying about its possible contents. HHS has already been briefed on the report, and I believe members of Congress have also been briefed (although I don’t know how many).

Good or bad, this report is likely to have a huge impact on ME/CFS advocacy. But how do we define a good or bad report? Some advocates have said that anything other than an adoption of the 2003 Canadian Consensus Criteria will be a failure. This outcome seems unlikely to me, only because it would be hard for anyone to justify spending $1 million and more than a year to simply adopt something that already exists. I think everyone would agree that a report that goes in the direction of broad Oxford-like criteria or psychogenic language will also be a complete failure. Again, this seems unlikely to me given that the committee includes a number of experts who would never agree to such a move. In fact, Dr. Klimas made comments at the P2P meeting that suggested she thinks narrow criteria would identify clean cohorts for biomarker and treatment discovery.

Until we have the report, we won’t know where it falls on the good-bad continuum. But I find it helpful to think about critical elements for success in advance, in order to more fairly judge the report on its merits (or lack thereof). So here are my personal must haves for a successful report:

Post-exertional malaise: This is nonnegotiable to me. The new definition must require PEM. The report should also explicitly define PEM, distinguish it from the single symptom of fatigue, and make suggestions on how it can be measured in clinic.

Core features: Dr. Lenny Jason has shown in multiple papers that criteria focusing on the core features of the disease are more precise, without incorporating patients with primary psychiatric disorders. Dr. Jason’s work shows that PEM, cognitive dysfunction and sleep disturbance are the three core features. Pain and autonomic dysfunction are frequently experienced by some patients but may be more useful in subsetting. So I think a successful definition should not present a laundry list of required symptoms like the 1988 Holmes or even the ME-ICC.

Frequency/Severity: Another theme of Dr. Jason’s work is setting minimum thresholds for frequency and severity in order to weed out people who do not actually have this disease. I hope the new definition will address issues like how long someone has to be sick to qualify for diagnosis, how frequently symptoms are experienced, etc.

Name: CFS or anything like it has to go. I argued in one of my memos to the IOM committee that ME was a better name, both because of evidence of inflammation in patients and because a diagnostic code already exists. I heard a rumor that ME will not be the new name, but the person who made that statement did not cite a specific source for the information. A new name will be problematic, as we may languish code-less for years, and still face the problem of the code being listed under “symptoms” instead of “neurological diseases.”

Making the diagnosis: The report should provide guidance to clinicians on how to make the diagnosis. What tests should be run? What diseases should be eliminated? Should we be referred to specialists, and which ones? Previous studies have shown that 80% of people with this disease may be undiagnosed. The report should provide recommendations on how to change that.

No psych: Any credence given to psychogenic explanations for the disease will be a failure. Agnostic statements on whether this is a psychological disorder will also be a failure.

Where To Next: Ideally, the report should make recommendations on where we go from here. Should a new prevalence study be done? Should CDC retool its multisite study? How should research on subjects that did not require PEM be interpreted going forward? How should the definition be rolled out to healthcare providers?

This may not be a comprehensive list of essential elements for success. What do you think is essential in a successful IOM report? What deal breakers would make the report a failure?

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Guest Post: Slightly Snarky

Joe Landson authors this guest post on the chasm between patient experiences and the people who need to understand them.

We suffer through many devastating symptoms, but today I’m only thinking of one. It’s perhaps the most devastating effect of this illness, while not actually being a symptom at all.

It’s the sensation of being surrounded by idiots – the feeling that we have described our symptoms over and over, documented them, even proposed peer-reviewed literature-based explanations for them, only to hear the response: “So… you feel tired?” On orthostatic intolerance: “So, you feel dizzy?” On irritable bowel: “So, you have a tummyache?” It’s such fun I could go on, but I’ll stop there.

This non-symptom that probably all of us experience has led to the distinct impression that only other patients and caregivers get it, that we must cling to each other to keep from losing it completely. Indeed, our cliquishness has prompted many psychiatrists and social scientists to theorize that we suffer from mass hysteria. (Of course that’s impossible; we’re much too socially isolated to have mass anything.)

Of course, clinicians and government health officials must sympathize with our plight, because they have the mirror image of this condition. With a group of us in a room, they apparently experience the unshakable sensation of being surrounded by catastrophizing hypochondriacs. At least they act like they are, based on referral patterns, research funding levels, and non-adherence to the FACA. It’s the best explanation I can think of for how we’re treated – regardless of whatever sympathetic lip service we receive in meetings and conferences.

And so we float past each other, health workers and patients & advocates; trapped in our respective knowledge bubbles.

The problem, of course, is not limited to us. There has long been a chasm between how patients experience an illness on one hand, and how medical professionals define and treat it on the other. It’s a recognized problem that several efforts try to address. One of these efforts is patient-centered outcomes research, pursued by the Food & Drug Administration (FDA), amongst others.

Towards this goal, the FDA revised their guidelines for ME/CFS treatment research. The way I read the FDA’s instructions is this: Don’t have a validated outcome? Make one up. Make up anything, validate it statistically, and show that your proposed intervention moves the outcome score upwards on a graph. Show that the intervention is otherwise safe (to the patient and the graph), and we’ll strongly consider approving it. I hope I’m misreading it, but that’s how I see it, and it does not bode well for serious research. On the other hand, it may get a treatment approved in our lifetimes. Time will tell.

I have other doubts. Is patient-centered research really the best way to fill the chasm between the illness we have, and the one others (don’t) see? Probably some medical professionals equate patient-centered anything to putting the patients in charge of the asylum. (Given some of the doctors we’ve met, wouldn’t this be an improvement anyway?) For me, the phrase patient-centered research recalls Count Rugen (the six-fingered man) testing his suction-based torture device on Westley and asking, “And remember, this is for posterity so be honest. How do you feel?” (What could be more patient-centered than that?)

Speaking of doctors we’ve met, I will never forget the Veterans Affairs rheumatologist calmly explaining to me that while he treated fibromyalgia, which was real because it had a pressure point test, he could not treat chronic fatigue syndrome, which was just a form depression. Interestingly, he made this pronouncement shortly before his colleagues dropped the pressure point diagnostic test for fibromyalgia, and replaced it with a revised definition that sounds an awful lot like a functional disorder. Reality comes and goes, doesn’t it?

In Brain on Fire: My Month of Madness, Susannah Cahalan describes her experience with NMDA Receptor Autoimmune Encephalitis (AE). Its symptoms are utterly indistinguishable from psychosis or schizophrenia; brain scans show nothing. Moreover, doctors’ approach to the illness is a self-fulfilling prophecy. If treated as a psychiatric disorder, AE gets worse and becomes permanent or fatal. If treated as the autoimmune disease it is, AE may ameliorate and even remit to a full recovery, as it did for Cahalan. She acknowledges she was lucky, and that society really has no firm idea how many are unlucky, given a vague psychiatric label, and left to rot or die.

AE may or may not have specific medical answers for us. However the situation is absolutely the same. If health care providers continue to treat us as if we have belief issues, then their own belief will self-fulfill. Our condition will effectively become permanent, and more of us will succumb to paranoia and despair.

Of course, correcting doctors’ beliefs will not suddenly make us well. The best it might do, in the short term, is end the graded exercise and other “treatment” imposed by Count Rugen Peter White and others.

Our beliefs must change, too. Not about our illness per se: Rather, we have start believing that no matter how few or poorly funded, folks genuinely are trying to help us. There is no conspiracy; instead, there is a giant chasm in medical knowledge that has swallowed us up, along with other diseases, too.

And I have to stop being so snarky. Tomorrow.

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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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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 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


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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