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Patients to DHHS: Fix the Broken ME/CFS Case Definitions NOW!

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On May 12 - International Awareness Day for ME/CFS/FM/MCS/etc - Phoenix Rising joined with 8 other US ME/CFS patient organizations and 26 independent patient advocates to call on the Department of Health and Human Services (DHHS) to finally fix the problem of the many and diverse case definitions associated with our disease. In a letter to Secretary Sebelius, Dr Howard Koh, Dr Thomas Frieden and Dr Francis Collins, we explained our concerns about the current definition activities of the DHHS in relation to "Chronic Fatigue Syndrome", and listed the steps we believe must be taken to rectify the situation.

You can read our letter to the DHHS here.

The signatories on the letter are:

Chronic Fatigue Syndrome, Fibromyalgia and Chemical Sensitivity Coalition of Chicago, CFS/Fibromyalgia Organization of Georgia, Inc., MAME (Mothers Against Myalgic Encephalomyelitis), PANDORA (a.k.a. CFS Solutions of West Michigan), Phoenix Rising, The Fibromyalgia-ME/CFS Support Center, Inc., Rocky Mountain CFS/ME and FM Association, Speak Up About ME, Wisconsin ME/CFS Association, Inc., Bobbi Ausubel, Rich Carson, Lori Chapo-Kroger, R.N., Kati Debelic, R.N., Mary Dimmock, Pat Fero, MEPD, Joan Grobstein, M.D., Jean Harrison, Eileen Holderman, Suzan Jackson, Jill Justiss, Mindy Kitei, Michele Krisko, Denise Lopez-Majano, Mike Munoz, Matina Nicolson, Donna Pearson, Leela Play, Justin Reilly, J.D., Mary Schweitzer, Ph.D., Meghan Shannon MS MFT, Marly Silverman, Rivka Solomon, Tamara Staples, Charlotte von Salis, J.D., Michael Walzer.

For those of you who wish to sign this letter and become a part of this important initiative, we will provide a mechanism to do that within a few weeks and will send out additional information at that time.



Why have we written this letter?

Of all the issues that we face today, the one issue that has created the most problems is the diverse case definitions associated with our disease. This single issue has severely impacted research, drug development and clinical care and misled the medical community on the very nature of this devastating disease, causing many doctors to not believe that their patients are really sick. Until this issue is addressed, patients will continue to pay the price. This must stop now.

Today, the CDC states that there are at least 5 different definitions for “CFS”. Three of these definitions - the Canadian Consensus Criteria, the ME International Consensus Criteria and the Pediatric Criteria - require hallmark criteria like PEM/PENE and neurological, immunological and energy production impairments. Unfortunately, two of the most commonly used definitions, Fukuda and Oxford, do not require these hallmark criteria. In fact, Oxford only requires 6 months of disabling fatigue - no other symptom - and allows primary psychiatric disorder.

The result? Myalgic encephalomyelitis, the disease seen in outbreaks throughout the twentieth century and recognized by the World Health Organization in 1969, has disappeared, and in its place we are left with “CFS”, an amorphous umbrella of unrelated fatiguing conditions including, according to the literature, depression, deconditioning, medically unexplained chronic fatigue, and for some researchers and clinicians, fatigue due to “excessive rest” or “false illness beliefs”. In clinical practice, the diagnosis of CFS is given to a heterogeneous mix of patients – those with ME, those with the varied fatiguing conditions listed above, and those who were misdiagnosed or whose doctors use the diagnosis of CFS as a catch-all for unexplained fatigue. And in 2012, an American Family Physician article proclaimed that Oxford and Fukuda are the appropriate definitions for “CFS” and further stated: “[CFS] patients with poor social adjustment, a strong belief in an organic cause for fatigue, or some sort of sickness benefit (i.e., financial incentive) tend to have worse responses to [cognitive behavioral] therapy.”

Exactly what disease are we talking about here?

Patients have paid dearly for the proliferation of these overly broad and non-specific definitions – bedbound or homebound, unable to work or take care of their families, suffering for 10, 20, 30 or more years from the myriad symptoms that plague their bodies, unable to get adequate medical care and ultimately more likely to die prematurely from cancer, cardiovascular disease and suicide.

As Dr. Carruthers stated in the ME International Consensus Criteria, “Research on other fatiguing illnesses, such as cancer and multiple sclerosis, is done on patients who have those diseases. There is a current, urgent need for ME research using patients who actually have ME.” We must have a disease appropriate definition for ME that is separate and distinct from all the other unrelated conditions encompassed by the overly broad, fatigue-focused “CFS” definitions.


What are we asking for?

Our letter to the DHHS asks them to:
  1. Adopt a disease-appropriate case definition for ME now, utilizing the Canadian Consensus Criteria as recommended by DHHS’ own advisory committee CFSAC, and train doctors with appropriate medical guidance.
  2. Stop using the terms “CFS” and “Chronic Fatigue Syndrome” along with the non-specific definitions like Fukuda and Oxford and the medical education material based on these definitions.
  3. Manage the adoption of the Canadian Consensus Criteria to ensure that insurance and disability do not lapse and that no patients fall through the cracks.
  4. Fully engage ME stakeholders in the planning and execution of the adoption of the Canadian Consensus Criteria.
Is this the right thing to do?


You may ask whether we really know enough about the disease or whether we need more study before we change definitions. Certainly, with more study, we can better operationalize the definition and validate biomarkers to make patient diagnostics easier. But in the meantime, we know that PEM/PENE is a hallmark symptom that reflects a distinctive biological pathology and we must utilize a disease definition that requires that symptom.

Some of you may prefer the ME International Consensus Criteria over the Canadian Consensus Criteria. The ME-ICC certainly has some excellent features. But practically, the Canadian Consensus Criteria has been used clinically and in research for a decade. Studies have been done with it. The U.S. government has posted the IACFS/ME Primer, based on the Canadian Consensus Criteria, on DHHS’ Guidelines.Gov. This is more likely to be acceptable to DHHS and is a reasonable first step, especially when considered against the alternative of continuing to use Fukuda while more study is done.

What about dropping the name “CFS”? You may be concerned that this means we will lose the literature base that has provided insights into the pathology of ME. Admittedly, some of the best articles used the term “CFS”. And so do some of the worst. The point is that the literature base is a mess because multiple diverse and unrelated definitions have inexplicably been allowed to use the very same name for years. We all should stop using the term “CFS” because it no longer has any real meaning.

Finally, what about the name ME? Does it really describe the disease? Is there a better name? That is a question that science will need to decide over time, something that has happened in many other diseases. But what is clear is that “chronic fatigue syndrome” will never be an appropriate name and should never have been established as the alternative or synonym for ME.

Patients have borne the brunt of the failure to address the definitional issues for the last thirty years. We cannot wait for more study to finally stop the harm being done to patients, especially given that more study with non-specific definitions will only perpetuate the problem. The time to address this problem is now.


Questions and Answers

We realize that patients, carers and advocates may have a number of questions about this initiative, and we hope that the following questions and answers will address any concerns you may have.


1. We can not abandon the patients that have been incorrectly given a “CFS” diagnosis.

This is very true. It is critical that implementation of this change is carefully managed so that these patients are re-evaluated and given a correct diagnosis. If unexplained conditions remain, it will be necessary to perform the studies needed to understand these conditions and establish more appropriate names and definitions.


2. We can not afford to have our disability or insurance impacted.

Yes, this is very important. It will be important to have a carefully thought out implementation plan that manages this to ensure that patients do not lose disability or insurance benefits.


3. The vast majority of the 6000 articles in the literature use the name “CFS”, not “ME. If we stop using the name “CFS”, we will lose all that literature.

Currently, when the search term myalgic encephalomyelitis is used, the CFS literature is returned. This will not change. But that literature base contains both articles relevant to ME and also a significant number of articles about “CFS” and child abuse, false illness beliefs, deconditioning, etc. This creates significant confusion for anyone trying to use that literature. For that reason, the non-specific term “CFS” should be abandoned by the U.S. and more specific terms like ME used going forward.


4. We have more important issues to deal with such as funding, and attracting new doctors and researchers.

It is critical that we have more funding but if we don’t fix the definition issue first, we will continue to study the wrong disease and have progress impeded by poor definitions. The resultant confusion will make it difficult to attract young researchers and doctors who will not see career opportunity in “CFS”.


5. Research centers have recently been established and if we stop using the name “CFS” we will confuse our donors.

It is true that a number of research institutes have recently been opened and some of them use the term “”CFS” or even “CF”. But the donors to these institutes today have a personal connection to the disease. They will continue to fund. Attracting additional funders, however, will be negatively impacted by the confusion around the disease. The sooner we can resolve this issue, the better in the long run.


6. CFS biobanks have been established using Fukuda and we don’t want to lose those samples.

The biobanks that have only been characterized by the Fukuda definition could contain a mix of patients with the hallmark criteria of ME and those who do not have these hallmark criteria. Using these mixed samples will continue to confound research. It is important that we have a well-characterized set of samples in the biobank and know which samples are from ME patients.


7. ME may not be the right name. Shouldn’t we wait for the science to figure out what the right name is?

It is possible that with further study, we will determine a better name than ME and it will naturally evolve. But ME, adopted by the World Health Organization in 1969, is the best placeholder until that time and avoids the serious issues caused by the use of the term “CFS”.


8. The best course is to tighten up the “CFS” definition, not get rid of it. Then we can keep the literature base, the biobanks, etc.

There are two problems with this approach. First is the long history of the term “CFS”, which is non-specific and now widely associated with diverse conditions, especially including psychiatric issues. This has severely tainted the term and made it clinically meaningless. Second, the term “CFS” is used for those studying patients that meet Oxford criteria (essentially chronic fatigue) and we have little control over that continued usage.


9. Lenny Jason recently published a paper that reports that the ME-ICC and the Canadian Consensus Criteria include more psychiatric co-morbidities than the Fukuda and recommends that more study be done. Does that mean we should wait to recommend any criteria until then?

  • Dr. Jason’s paper did find that the ME-ICC found more psychiatric co-morbidity than Fukuda. But Dr. Jason acknowledged the need for more study because this one used a questionnaire designed for Fukuda CFS, and that they were unable to assess one of the key ME-ICC criteria because data on this criteria was not available. Further, the study did not look at homebound or bedbound patients.
  • But what is also significant in Dr. Jason’s study is that ME-ICC identified a much tighter group of patients (39 compared to 113 for Fukuda) with more of the functional impairments and physical, mental and cognitive problems seen in ME-ICC patients than in those meeting the Fukuda criteria.
  • Clearly additional study is needed to operationalize the definition and to improve how it characterizes the disease, especially around subtypes. But continuing to use the 19-year-old consensus-driven Fukuda definition - which is also not operationalized and does not describe subtypes - in the meantime is not going to advance that knowledge and will only continue to hurt patients.
  • The Canadian Consensus Criteria has been used clinically and in research for over 10 years and better represents the disease. Using the CCC now will allow us to begin to make forward progress in research and identifying treatments, and begin to address the disbelief in the medical community.
10. Is this the same thing as the Name Change initiative?

No. This is first and foremost about the definition being used – adopting a definition that effectively describes the disease and stopping the use of the definition – and name – that have created so much confusion and so many problems.


11. Why CCC and not ME-ICC?

The CCC has been used clinically and in a number of studies, providing the experiential foundation for its use. It is expected that as additional data is obtained, this definition will evolve. This must be done in partnership with the experts who developed the ME-ICC and the CCC.



We hope and believe that this initiative will be welcomed by the majority of the patient community, and we hope that the questions above have addressed any concerns. Of course there is always room for debate over details, but very few if any of us are happy with the existing definitional mess, and this letter represents a consensus amongst 9 patient organizations and 26 independent advocates on the best path towards change. As such, we encourage the community to get behind this initiative and seize this opportunity to resolve the problem of the broken case definitions used for our disease.




Phoenix Rising is a registered 501 c.(3) non profit. We support ME/CFS and NEID patients through rigorous reporting, reliable information, effective advocacy and the provision of online services which empower patients and help them to cope with their isolation.

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Comments

I don't know if you used to promote the CCC before the ICC were published. I had assumed that was the case, but perhaps it was only after the ICC were published.
Thanks, Bob, for clarifying your references. As you say, my comments were posted a year ago, after the publication of the ICC. At that time, we were discussing the relationship between ME and CFS in the context of the NCHS reclassification request and the Joint Request for Action. The NCHS reclassification request had claimed that “when properly defined, CFS is the same as ME,” and the Joint Request for Action claimed that “many experienced clinicians and researchers recognize the equivalency or close similarity of ME and CFS based on the growth in scientific understanding and have adopted the term ME/CFS. All of DHHS should follow the NIH’s lead and adopt the term ME/CFS as recommended by the CFSAC in October 2010.”

You found the discussion constructive (“Wow, what a constructive thread!”) and offered to extract proposals or suggestions that could then be discussed and debated. You challenged me to produce published guidance supporting the separation of ME from CFS. In developing a proposal that differentiated ME from CFS, I drew first on an interview explaining that the CCC was originally intended to be an ME definition and then on Dr. Carruthers' published reference to a study by Dr. Jason comparing the CCC to Reeves (2005) and confirming the separation of ME from CFS cases in that context.

During those discussions, we noted certain gaps within the expert guidance. Mary commented, “For everything that ICC does to explicitly state that ME patients defined by ME-ICC should be removed from patient populations defined by the NICE criteria and Reeves empirical criteria, it was silent on how to handle patients diagnosed by Fukuda. I wish I knew why.” She and I privately questioned whether it would be appropriate to seek clarification from the International Consensus Panel.

As a patient of Dr. Carruthers' at that time, I took the opportunity to explain to him the need for expert guidance concerning the relationship between the ICC and Fukuda, particularly for the benefit of American patients. He encouraged me to contact the International Consensus Panel. Clarification from the Panel came last October in the ME Primer.

The statement by the International Consensus Panel clarified not only the relationship between the ICC and Fukuda, but also the relationship between the ICC and the CCC. It divided the CCC, removing ME patients who meet the “refinement of patient stratification” provided by the ICC: “Those who fulfill the criteria have ME; those who do not would remain in the more encompassing CFS classification.”
 
Gene expression alterations at baseline and following moderate exercise in patients with Chronic Fatigue Syndrome and Fibromyalgia Syndrome.
I've been interested in genes lately, so took a closer look at this one:

The increase of so many genes might indicate that upstream transcription factors common to all of these genes are dysregulated and control these downstream genes in a pathological fashion in CFS. Interestingly, all of the genes measured here are interconnected by the transcription factors CREB, GR-alpha (part of NR3C1, the glucocorticoid receptor), and NF-Kappa B1. Previously, NR3C1 polymorphisms were found to be associated with CFS [22–26]. In addition, Maes et al [27] have shown increased NF-Kappa B production in leukocytes of CFS patients, and Kim et al. [28] have shown increased DNA binding of NF-Kappa B in direct proportion to increases in exercise intensity.
NFKB1 (NF-Kappa B1) is the location of one my rare alleles (rs4648039), so maybe that's related?
 
More research needs to be done, but there is research into Post Exertional Malaise.
The studies that you've posted are included in the ME Primer's discussion of the pathophysiology of PENE (pp. 2-4). I haven't listened yet to the whole of Dr. Snell's FDA presentation. Does he mention any newer studies underway?
 
The studies that you've posted are included in the ME Primer'sdiscussion of the pathophysiology of PENE (pp. 2-4). I haven't listened yet to the whole of Dr. Snell's FDA presentation. Does he mention any newer studies underway?
It's not a long presentation, but I haven't yet listened to it all the way through either. I haven't seen him discuss any post-exertional research apart from his own VO2max / cardiopulmonary / anaerobic threshold work. Someone else has said that Dr Snell has a new study pending, but I don't know the details, and I haven't yet noticed Snell mention this in the video.
 
Wait a minute. Even if it turns out that the two-test VO2 Max is not significantly associated with small groups of ME/CFS patients, the test itself is still reliable, correct? So what happens to those people who previously dropped up to 50% on the second test??? Are such dramatic and unique results for some individuals just going to be ignored as outliers?

I still await with interest the latest update on anaerobic threshold research.
 
Wait a minute. Even if it turns out that the two-test VO2 Max is not significantly associated with small groups of ME/CFS patients, the test itself is still reliable, correct? So what happens to those people who previously dropped up to 50% on the second test??? Are such dramatic and unique results for some individuals just going to be ignored as outliers?
I get the feeling that, as far as Dr Snell is concerned, it's all a work-in-progress.
He seems to be exploring this area of research to find the best tests.
 
Regarding Beth Under in this CFSAC video:

It's just my own interpretation, and I may well change my mind, but I am encouraged by Beth Unger's attitude.
I wasn't encouraged to begin with, but I've watched parts of the video a few times now, and my perception has changed.
She isn't quite where we want her to be, but I believe she is moving in the right direction.

Some of the CFSAC members' have consistently complained about content on the CDC's websites, and their approach to diagnostic criteria and education. (And I agree with them.)

But in terms of the research that Unger is carrying out (apart from not yet incorporating two-day exercise tests - which she hasn't ruled out), much of what Unger says in the CFSAC video, in relation to the research she is carrying out, gives me cause for hope that she is taking ME seriously, and has sort of rebooted the CDC's approach to ME, starting afresh with collecting the empirical data. (Something that should have been done 30 years ago.)

She acknowledges the severity of the illness, she acknowledges the physiological changes, she acknowledges the complexity of the illness, and the unhelpful heterogeneity of the CFS criteria. And she gives no hint that ME is anything other than a serious and debilitating biomedical illness.

She says that the more symptoms someone has, the greater the severity, or vice-verse. (In other words there is a correlation between severity and the number of symptoms.) (This seems like a helpful insight, and is miles away from the psycho-social model.)

She seems to recognise that heterogeneity is the biggest problem. And she's looking for data to find well-defined subsets. That's her mission. And I think it's the correct and best mission for her to be engaged in. I think it's exactly what the CDC should be doing, as long as they do it properly.

She's not overly keen on promoting the CCC, although perhaps the CDC do seem to be moving towards it, slowly, but she also acknowledges that Fukuda is inadequate, and that's why she's working towards new criteria, looking for empirical evidence to find well defined subsets of patients.

She says that in the long term, none of the diagnostic criteria will be perfect, and she is looking towards defining subsets by looking at treatments, and finding out the differences between the patients who respond and those who don't respond. She gave Ampligen as an example of where some patients respond to treatment and others don't.
She says that finding out why some patients respond to treatments (what it different about them - are there any biomarkers) will probably prove to be the best way forwards in terms of defining the disease. I think she's spot on.

In the video, they have a discussion about post-exertional malaise (which Unger helpfully said is not a very helpful description, and that post-exertional exacerbation, or post-exertional relapse might be better), and that seems to be one of her focuses in her study. She is aware that this might prove to be a way to define a subset, and she is aware that some experts say that this is a defining feature of ME. She's proactively looking at the related data in her study.

I wasn't too hopeful about Unger for a long time, but I think she is actually beginning to 'get it'... i.e. to understand the nature of the illness from the patients' point of view, and what needs to be done to understand it from a scientific point of view. And she seems receptive to suggestions and input from the CFSAC meeting. There's a long way to go, but I'm encouraged.

I might be wrong about it all, but that's the feeling I get from listening to her.
 
A few more details about the CDC study.

Stage 2 of Multi-site CFS Study.

Follow-up of CFS patients enrolled in Stage 1.
- Saliva for morning cortisol profile.
- Blood for DNA and RNA


Details taken from this video:
 
She says that the more symptoms someone has, the greater the severity, or vice-verse. (In other words there is a correlation between severity and the number of symptoms.) (This seems like a helpful insight, and is miles away from the psycho-social model.)
Actually this does fit into the BPS models. Many believe that the more unexplained somatic symptoms someone has, the worse their presumed psychosomatic disorder is.
 
Actually this does fit into the BPS models. Many believe that the more unexplained somatic symptoms someone has, the worse their presumed psychosomatic disorder is.
Oh yes, that's right. Thanks for spotting that. But Unger was referring to her data, so she's not basing her assertion on a hypothesis. I got muddled about that because someone else on the committee panel (Fred Friedberg?) mentioned (@0.28.30) that the ICC selects for 'psychiatric disorder' at a high rate (he didn't use the term 'comorbidity') (perhaps he was referring to Jason's recent small study), and suggested a qualitative approach to diagnosis using fewer symptoms for a diagnosis. Unger said she remained committed to the data, but would prefer a simple diagnostic criteria if the data allows. She was very clear that she is purely being driven by the data. She seems to be approaching the illness afresh, with an empty slate. For example, when asked about post-exertional malaise, and if she is agnostic about its importance, she said that she will let the data decide, but that she will certainly pro-actively analyse the data with a view to evaluating the significance of PEM and attempting to determine subsets based on PEM.
(I'm paraphrasing to the best of my memory and understanding. Some of this discussion is roughly @0.28.00 in the video.)
 
A new 'expert' working group is being set up by the NIH as the start of a new project to scientifically analyse all the research data, with a view to assessing the current diagnostic definitions. They want to find out where the strengths and weaknesses of each set of criteria lay. It seems like a very big project. Details of the working group will be posted online when available.

Details about the working group for the NIH's diagnostic criteria research review will be published here, when available:
http://www.effectivehealthcare.ahrq.gov/
 
Bob my friend - you should write an article. You must have analysed this meeting so much by now. Thanks for the links. I was listening to them myself this morning whilst playing minecraft. Hard to follow I felt. An article might be nice - assuming one hasn't already been done that focuses explicitly on these points :)
 
Bob my friend - you should write an article. You must have analysed this meeting so much by now. Thanks for the links. I was listening to them myself this morning whilst playing minecraft. Hard to follow I felt. An article might be nice - assuming one hasn't already been done that focuses explicitly on these points :)

Thanks Firestormm. Yes, there is a lot of information. (I had to watch the videos without multitasking to make sense of them.)

I've scrutinised some of the videos because the CDC, FDA and NIH seem to be starting some very interesting projects.
There is quite a lot going on, and CFS seems to have been prioritised within the NIH.
CFS seems to have been placed at the top of a priority list, and many different health departments seem to be getting involved.

But I still haven't quite grasped what's going on, so I couldn't write an article.
(I'd quite like it if someone else could explain it all to me!)
(I also don't understand how the various US health departments relate to each other, so it can be a bit confusing to understand exactly who's doing what.)

The CDC study seems to be evolving, and I think that Beth Unger is open minded about where it will lead, and what tests will eventually be involved. They are already taking the study to a new level, and taking DNA/RNA samples, and testing for morning cortisol levels. And also doing cardiopulmonary testing during exercise tests, and cognitive testing post-exercise. A number of members at the CFSAC meeting were urging Unger to meet Dr Snell, and she was taking notes, so hopefully she will meet him, in which case she might end up including two-day anaerobic threshold tests. Let's hope so. She's already hinted that she may well include post-exertion resting heart rate tests, which the committee panel urged her to do.

The NIH (or FDA? or both?) is setting up a parallel study which aims to analyse the existing research data (in relation to assessing all the current diagnostic criteria), with a view to assessing the strengths and weaknesses of each set of criteria, and with a view to finding out where the gaps in the knowledge are, and what future research is needed to fill those gaps.
The project is being set up with help from ME patients, ME advocates, ME organisations, and ME experts, to form a working group which will guide the scientific group who are analysing the data. It was explained that the working group will form the questions that the scientific group will aim to answer. And the details of the working group and their 'questions' will be placed online.

It's an interesting project, and financial resources have been committed to it. I think its success all depends on the working group that is being set up. Some of the CFSAC committee members are on the working group, and it seems that some well-known patients are included, but details were not given. I thnk they said that the project is starting late June to early July. (So that's about now.)

The NIH representative (Susan Maier - Deputy Director, Office of Research on Women's Health) also mentioned funding for CFS research, and encouraged people to apply for grants, and suggested that the amount of money available for CFS research has been increased, but I don't think she gave exact details of available funding.
 
It's an interesting project, and financial resources have been committed to it. I think its success all depends on the working group that is being set up. Some of the CFSAC committee members are on the working group, and it seems that some well-known patients are included, but details were not given.
According to the Assistant Secretary, the NIH EbMW
consists of a thorough, unbiased evidence review of the literature related to clinical research outcomes compared across case definitions and culminating in a workshop composed of experts and patients. The workshop participants and panel members will use the evidence review to evaluate the strength of evidence for case definitions with the goal of identifying the most consistent outcomes....
How many clinical research outcomes (using which research case definitions) can they be expecting to review and compare?

A researcher herself, Dr. Fletcher reminded CFSAC, “We wanted to have a meeting of experts, advocates and clinicians to meet together and that we would take as a basis of starting the international case definition...2003. That was all specifically spelled out in our resolution. This substitution is just totally unacceptable.”
 
I wasn't too hopeful about Unger for a long time, but I think she is actually beginning to 'get it'... i.e. to understand the nature of the illness from the patients' point of view, and what needs to be done to understand it from a scientific point of view.
Dr. Unger seems to be good at turning a deaf ear whenever it suits her. At the Ottawa conference in September 2011, she spoke after Dr. Carruthers during the “Case Definitions for Research and Practice” session. And at the FDA workshop in April of this year, she spoke after Dr. Snell on the “CFS and ME Clinical Trial Endpoints and Design” panel.

Dr. Carruthers concluded his presentation this way: “As Osler also said, 'Listen to your patients. They are giving you the diagnosis'. Now we have the technology to confirm this directly for this complex disease– if we use it.” Dr. Snell concluded his FDA presentation, “A single exercise test may be insufficient to distinguish between CFS/ME and sedentary controls.”

The question isn't so much whether Dr. Unger gets it, but whether she'll act on it.
 
Dr. Unger seems to be good at turning a deaf ear whenever it suits her. At the Ottawa conference in September 2011, she spoke after Dr. Carruthers during the “Case Definitions for Research and Practice” session. And at the FDA workshop in April of this year, she spoke after Dr. Snell on the “CFS and ME Clinical Trial Endpoints and Design” panel.

Dr. Carruthers concluded his presentation this way: “As Osler also said, 'Listen to your patients. They are giving you the diagnosis'. Now we have the technology to confirm this directly for this complex disease– if we use it.” Dr. Snell concluded his FDA presentation, “A single exercise test may be insufficient to distinguish between CFS/ME and sedentary controls.”

The question isn't so much whether Dr. Unger gets it, but whether she'll act on it.
I think it's a process for her. I agree that she's been slow, and I am cautious about praising her prematurely. But she seems to be collaborating with the ME community and she seems to be listening. The changes that she is incorporating into her study suggests that she is beginning to 'act'. And her comments at the CFSAC meeting suggest that she is receptive, for example, her apparent willingness to incorporate post-exertion resting heart-rate into the study, as recommended to her. It's too early to know if she will make a difference. But I don't think it's all bad at the CDC at the moment. There seems to have been a major change, and perhaps the pace of change is increasing.
 
How many clinical research outcomes (using which research case definitions) can they be expecting to review and compare?
I'm not particularly optimistic about this review. Reviews tend to be conservative, too narrowly focused, and short-sighted. And nearly all the literature is based only on Fukuda. However, there is a possibility that they will conclude that Fukuda is too inclusive (not specific enough), which would be helpful. Jason has published papers about this, and perhaps they might use that sort of research for some of their conclusions.

I think that the outcome of the review might depend a lot on the working group. (It's a shame that the creation of the working group was not a transparent process, but I hope that it will mostly involve individuals whom we approve of, as it seems to have come off the back of the FDA stakeholder meeting.) If the working group set the right agenda, and ask the right questions, then the systematic review just might come up with some answers/proposals/suggestion that we find acceptable and helpful.

Like I said, I'm not particularly optimistic about this process.
 
I think it's a process for her.... It's too early to know if she will make a difference.
The CDC cannot plead ignorance. As Chris Cairns wrote of the FDA, they should “fish or cut bait. After this two-day FDA conference on April 25th and 26th, [they] can no longer plead ignorance about the true nature of this illness.”