CDC Multi-site Study – An interview with Beth Unger

January 31, 2014

The CDC multi-site clinical assessment of CFS/ME is now underway, and Bob took the opportunity to interview Dr Beth Unger, the lead scientist in charge. The outcomes of this significant study are likely to be widely influential and the means by which the CDC employ objective measures has become something of a hot potato, especially in relation to exercise testing…

Elizabeth, R. Unger, PhD, MD Chief, Chronic Viral Disease Branch

Elizabeth, R. Unger, PhD, MD
Chief, Chronic Viral Disease Branch

The CDC department that oversees chronic fatigue syndrome, under the leadership of Dr Beth Unger, has begun a large study using data from 450 ME/CFS patients, collected at seven well known clinical sites across America (see below).

The CDC website describes the study as a “multi-site clinical assessment of chronic fatigue syndrome (CFS) to characterize patients with CFS or myalgic encephalomyelitis (ME) in clinical practices of clinicians with expertise in CFS/ME.”

“The study started in 2012 and aims to enrol 450 patients. Any patient (aged 18 – 70 years) that is managed or diagnosed with CFS, post-infective fatigue (PIF) or myalgic encephalomyelitis (ME) at any of seven participating clinical sites is eligible for participating in the study.”

No specific official clinical criteria (such as the Fukuda CFS criteria or the Canadian Consensus Criteria for ME) are required for patient recruitment. Instead, the participating clinicians are asked to use their own clinical judgement to include CFS/ME/PIF patients in the study.

The CDC website says: “The study will examine the differences and similarities between CFS/ME patients in the clinical practices of experienced CFS clinicians.” “The data collected using a standardized approach from expert clinical practices will be used to address the CFS case definition. Ultimately, this study aims to improve how we measure illness domains of CFS. This may allow patients to be sub-grouped to improve therapy and allow the underlying biology to be discovered.”

On paper, the CDC seems fairly ambitious in its aims: 

“CDC is fully committed to working with the CFS Advisory Committee (CFSAC) and DHHS to develop consensus about the case definition and name of this devastating illness. The need is not only for a case definition but also for reproducible standardized approaches to applying it, as well as for biomarkers to refine subgroups within the overall CFS patient population.”

The first stage of the study collected subjective measures from the patients, including clinical assessments and medical histories.

Dr Unger has said that ‘biologic’ measures are crucial to further characterize and sub-group patients, and has indicated that the early stages needed to be self-report measures in order to test the logistics of such a large study. She has said that the logistics were found to be successful in the first stage, and that they are now moving on to the second stage.

The second stage will enroll paediatric/adolescent CFS patients, as well as recruiting the controls (healthy people and people ill with other fatiguing illnesses), as comparison groups.

The devil is in the detail…

Dr Unger seems to be taking a robust evidence-based approach to defining the illness, illnesses, or subsets. If the study is done well, it could turn out to be a ground-breaking project, but if done badly, it could be worse than meaningless. If objective biological tests are not included in the long-term, then this might turn out to be a large but very shallow study, costing a lot of money and not providing any ground-breaking answers.

Depending on its ultimate design, and its implementation, this large study could potentially be ground-breaking. Extensive objective and biological measures are not yet included in the study, but the study is evolving, and Dr Unger explains that the current study may pave the way to, and enable, future biological testing in better defined cohorts.

However, strong feelings of discontent have been expressed – by patients and advocates – over Dr Unger’s decision not to include extensive objective or biological testing from the start. One such objective test that has been called for, is a two-day cardio-pulmonary exercise test (CPET), which seeks to measure cardio-pulmonary efficiency (by measuring values such as: effort, energy expenditure, oxygen intake, and heart rate) when patients use an exercise bicycle in two separate tests on consecutive days.

Hooked up for a CPET

Hooked up for a CPET

In small studies by Dr Christopher Snell and colleagues, CFS/ME patients were seen to have fairly similar CPET results to sedentary healthy controls on the first day’s test. But, significantly, for one of the efficiency measures, the healthy controls improved in performance in the second day’s test, whereas the performance among the CFS/ME patients was substantially worse on the same test.

This has been seen as a means of objectively demonstrating the symptom of post-exertional malaise – considered a key symptom of CFS/ME – and Dr Snell has said that this abnormal response to exercise is something he has seen only in these patients (see: Repeat Test Reveals Dramatic Drop in Exercise Capacity).
 
Dr Snell’s latest research study was small, but these intriguing initial results, if replicated by larger studies, may well confirm that 2-day CPET testing is a useful biomarker for the disease.
 
Members of the Chronic Fatigue Sydrome Advisory Committee (CFSAC) have suggested that Dr Unger contact Dr Snell to discuss the merits of a two-day CPET, which she has now done. We do not know the extent to which they discussed his research, or what will occur as a result, but Dr Snell has hinted that Dr Unger appeared to be open minded to including such a test at some stage in the future – indeed she does not rule it out in the answers provided to my questions (below).
 
The plans for the CDC’s study currently include a one-day CPET test, along with 48-hour post-exertional cognitive tests and post-exertional self-reported illness and symptom scores. Dr Snell has indicated that he believes there may be  merit in using the proposed post-exercise cognitive tests and post-exercise symptom scores. It is possible that these measures may demonstrate post-exertional symptom exacerbation unique to CFS/ME patients, or a subgroup of CFS/ME patients.
 
But it seems clear that Dr Snell and many patients are of the opinion that a two-day CPET should be included. The CDC study is of such significance that it seems a wasted opportunity not to do so.

Interviewing Dr Unger

There is limited official information available about the study, so I recently put some questions to the CDC. In reply, Dr Unger explained that she considers it important to first of all collect a comprehensive range of subjective data that will enable, stimulate, and pave the way for further studies using biological testing.

The questions and answers are quoted below, exactly as they were asked and responded to. The answers were received on December 19th, 2013.

1. What are you ultimately hoping to achieve from your study e.g. to create a new clinical or research diagnostic criteria, to determine biomarkers, to define subsets, to discover any research leads?

We hope that this study will help determine the best measures of the major illness domains of CFS.  These include measures of function, pain, fatigue, sleep, and additional symptoms cited in various case definitions.  These measures are needed in order to determine if patient subsets can be identified that will correlate with biologic measures that could guide therapy. 

These measures are also important to assist researchers in selecting patients that are better defined, a feature of study design that will help the field achieve replication and validation of results.  In addition, we hope that our study will contribute to developing outcome measures needed for clinical trials. The data collected in this study will be useful in evaluating current and proposed diagnostic criteria, but creating new CFS case definition criteria is not a goal.

Our study will also provide descriptive analyses of the clinical management of CFS by the participating experts.  Information on medication and other therapeutic and management tools could begin the process of developing evidence-based guidance for best practices for CFS care.

2. What data are you collecting about the patients? What biological/objective testing are you carrying out, or are you likely to add to the study? Are you collecting any tissue samples, and if so, what tests will you perform on the samples? If you are collecting DNA, what are you looking for in the DNA e.g. genetic predisposition?

 In the first stage of the study we are collecting standardized self-reported measures of CFS illness domains.   These include measures of function, pain, fatigue, sleep, and additional symptoms cited in various CFS case definitions.  We are also using data abstraction forms to collect information from study participants on the history of the present illness, detailed medical history, medications, lab test results, family history, infection and immunization history, and physical examination. 

In this second stage of the study, which began November 2013, we are collecting saliva to measure the wakening cortisol response.  We are also collecting blood to create a small biorepository of DNA and RNA that could be used to replicate promising findings from other groups.

3. Is the methodology of the study evolving as you proceed i.e. are you adding more elements to the study as you feel you need to? Is the study open ended? How will you know when your study is complete i.e. what data will you have collected? what type of conclusions will you have made?

The study methodology is evolving. Follow-up of patients involved in the first stage of the study will be continued in the second stage using a smaller set of questionnaires that will give data on disease course and on how well the instruments measure changes in their health.

The second stage will enroll pediatric/adolescent CFS patients. In addition, we are enrolling healthy people and those ill with other illnesses that include fatigue as comparison groups. Other components that are being added in the second stage include measures of cognition and exercise capacity as well as response to exercise. 

The study is currently being conducted under a contract that allows one-year extensions for up to five years if funds are available. While data collection will end when the contracts are closed, analysis and publication of the findings will continue. The study is expected to provide data to support new initiatives throughout the CFS research community.

4. Are you seeking to have an over-arching definition of fatiguing illnesses or is your focus on well defined subsets? Are you seeking to attempt to define subsets of the current Fukuda CFS diagnosis? Do you consider that post-exertional malaise (aka post-exertional neuro-immune exhaustion) i.e. delayed and prolonged post exertional symptom exacerbation that is not relieved by rest, could potentially define a distinct subset of Fukuda CFS? Are you actively looking for such a subset?

A new definition of CFS is not the objective of this study. We do believe the study will help identify subsets of CFS patients, and equally important, will provide the tools for clinicians and researchers to use to identify similar subsets. An essential feature of this study is that we did not use a case definition to enroll patients. The study relies on the clinical expertise of those physicians who have extensive experience in caring for those with CFS. 

Post-exertional malaise or post-exertional neuroimmune exhaustion is an important characteristic of CFS with no currently validated measures. We believe that the data collected in our study will help identify the best options for either measuring post-exertional malaise, or for identifying measures that correlate with this characteristic.

5. I have heard patients and advocates expressing concern that it is very important that your exercise testing is carried out over two days, but you have highlighted the practical difficulties of such a study. Could a small exploratory two-day testing program be carried out, with patients who are safely able to participate, to see how useful the results are?

Our primary objective is to measure the exercise capacity in as many of the enrolled patients as possible using a standardized protocol, and to monitor the post-exertional response for 48 hours with online cognitive testing and visual analogue scales of fatigue, pain, and symptoms. 

Maximal cardio-pulmonary exercise testing (CPET) with one day of testing and 48-hour follow-up of cognition was developed in consultation with Dr. Gudrun Lang (cognition), and Drs. Dane Cook and Connie Sol (exercise). We chose the one-day test so that more patients could be tested at multiple sites with rigorous standardization. 

The two-day test would require an additional overnight stay for those patients who travel long distances to attend clinic, and excludes those who are most severely affected because of the heavy physical toll. In developing the protocol, we strived to find a balance between testing that would yield meaningful data in the broadest representation without placing an unnecessary burden on the patients.

Results of the study will guide the next steps.  It may be that a trial of a two-day protocol could be indicated for some patients or to explore other aspects of the illness.

6. Over the years, the CDC has not always been popular with the ME/CFS community. Is there anything you can say that will provide patients with confidence in the CDC’s current program and with your department’s general attitude towards the patient population and the illness? Is the CDC making a fresh start with regards to ME/CFS? 

CDC’s CFS Program is committed to reducing the clinical morbidity associated with CFS while at the same time improving the quality of life for CFS patients and their families. We are focusing on projects addressing the most pressing needs associated with CFS. During our meetings with  CFS advocacy groups, we heard repeatedly about the need for improved health care services for CFS patients.

We currently have two types of initiatives related to this identified need. First, our study to collect data on CFS patients in multiple clinical practices; and second, developing educational materials, particularly targeted to healthcare providers, to advance the recognition and treatment of CFS.

Additional Information:

The seven participating clinical sites:

  • Pain and Fatigue Study Center, NY ………….. (Lead clinician: Dr. Benjamin Natelson)
  • Center for Neuro-Immune Disorders, FL ….. (Lead clinician: Dr. Nancy Klimas)
  • Open Medicine Clinic, CA ……………………….. (Lead clinician: Dr Andreas Kogelnik)
  • Sierra Internal Medicine Associates, NV …. (Lead clinician: Dr Daniel Peterson )
  • Fatigue Consultation Clinic, UT ………………. (Lead clinician: Dr Lucinda Bateman)
  • Hunter-Hopkins Center, NC …………………….. (Lead clinician: Dr Charles Lapp)
  • Richard Podell Clinic, NJ …………………………. (Lead clinician: Dr Richard Podell)

Summary of Objective Tests:

Current or proposed objective testing and biological sample taking:

  • One-day maximal cardiopulmonary exercise testing (CPET); with 48 hour post-exercise online cognitive testing (and also pain and symptom questionnaires) to attempt to identify post-exertional changes.
  • Saliva to measure morning (wakening) cortisol response
  • Blood samples to create a small bio-repository of DNA and RNA that could be used to replicate promising findings from other groups. 
  • Natural Killer (NK) cell function and counts; sample for serum archive.
  • Blood sampling for gene expression changes.

Possible future tests (i.e. tests that have not been proposed but not ruled out):

  • Two-day CPET. 

Further Reading:

Multi-site Clinical Assessment of CFS
CDC website  (click here)

Redefining ME/CFS? CDC Chief Reveals First Fruits Of Multi-Center Doctor Study At FDA Stakeholder Meeting
Simon McGrath, 11 May 2013  (click here)

Opportunity Lost
Jennie Spotila, 10 September 2013  (click here)

Discussion of Dr Snell’s recent two day CPET study
Repeat Test Reveals Dramatic Drop in ME/CFS Exercise Capacity
Simon McGrath, 29 Jul 2013  (click here)

Advocates Rebuffed: CDC Whiffs On Opportunity to Prove Reduced Exercise Capacity Present in Major Chronic Fatigue Syndrome Study
Cort Johnson, 15 September 2013  (click here)

Phoenix Rising Forum Discussion – New Dr Snell paper on exercise and CFS  
(click here)

CFSAC committee meeting – Spring 2013
Beth Unger discusses the CDC’s multi-centre study – YouTube Video:
(Click here to view video on YouTube)

CFSAC  committee meeting - Spring 2013
Stage 2 of Multi-site CFS Study - YouTube Video:
 
 

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91 comments

{ 91 comments… read them below or add one }

Roy S January 31, 2014 at 3:04 am


Dr. Unger, if you are reading this, why can't you do at least some 2 day CPET testing to compare it to the 1 day testing? Testing their validity ASAP could be extremely useful and might salvage a little trust from the patient community. It can't be fun to be continually criticized.

Thanks for the article, Bob.

lnester7 January 31, 2014 at 7:16 am

To all,

I have had the one day testing and I am extremely active patient. I work 40h and I was in one of my best days and even though I thought I would not see anything in the one day exercise, It was fast and obvious. My AT was 115 and took 5min to reach. So I could demonstrate without too much taxing to my system.

I am getting the 2 day one next and I will compare the differences, I will post back here to see if it is too much difference, but you will prove the disability issue with a day one.

Simon January 31, 2014 at 7:24 am

Thanks for a fine article, Bob. I thought you asked the questions we wanted answers to. And thanks for mentioning my article too!

I do think this study could provide a treasure trove of data and hope it will be accessible to any researchers that want it. Wish they had taken more biological samples eg blood that could be processed in many different ways, as opposed to being restricted to DNA/RNA and NK cell function.

I applaud the attempt to find outcome measures (questionnaire) that meaningfully measure change – self-reports are used by researchers of all persuasions but almost none of them have been shown to be good measures of change – which is actually the key thing you need in a clinical trial. Don't suppose they are using actometers as an objective measure of activity? Would be one way to validate the questionnaires.

I also think the 48-hour follow-up on symptoms and congnitive performance after a maximal test will be valuable. The Lights found differences in gene expression (and symptoms) after a single moderate exercise test. It would be interesting to run the Snell test on a random subgroup of patients to see how well the results from the single (CDC) and double (Snell) maximal exercise test compare.

Firestormm January 31, 2014 at 8:37 am

Interesting comment and experience from Els on our Facebook page: https://www.facebook.com/PhoenixRisingMECFS/posts/10152239014773384?stream_ref=10

Especially in relation to observing PEM at 72 hours – which I think tends to apply to me in most cases – or at least between 48 and 72 hours.

In order to take this into account, she exerted herself the day before she took the 48 hour test. However, I am not sure if this then makes a 'test' for PEM rather counter-productive or if it means we should be considering testing over a longer period to really establish the symptom.

As a test of functionality at the time – I can see the test has merit – but as something that is diagnostic of the disease – 'a marker' – I really can't see it myself. Not until bigger and better studies are done.

We did talk about this a lot when the Snell work was published. This need to ensure that patients doing the test were similarly exerting beforehand – maybe even having them on-site as it were the day before to all relax or at least measure and take into account what activity they had performed before testing took place e.g. distances traveled etc.

And of course – as Unger herself says above – such a test is not suitable for all with ME. I sure as heck couldn't do the exercise bike at the moment and I consider myself more able in other respects…

Be back later…

Christopher January 31, 2014 at 11:15 am

Our government is content to just keep slowly doing fruitless studies until we all eventually die out. Why bother caring?

The only time the feds gave us any attention is when researchers started getting too close to the truth. It was only THEN that they decided to spend money to shut us up and move the illness to that of "autoimmunity" and "inflammation of unknown etiology" – just enough research to placate patients but not enough to get anywhere with treatment. And what, we should be overjoyed that after decades of willfully neglecting physiological research into our disease that we're finally getting some crumbs?

We're not going to get anywhere with this ass-covering bullcrap. Why we tolerate this abuse by our government I do not understand.

(deep breaths, Chris, deep breaths)

AzizaJ January 31, 2014 at 11:39 am
Firestormm

Interesting comment and experience from Els on our Facebook page: https://www.facebook.com/PhoenixRisingMECFS/posts/10152239014773384?stream_ref=10

Especially in relation to observing PEM at 72 hours – which I think tends to apply to me in most cases – or at least between 48 and 72 hours.

In order to take this into account, she exerted herself the day before she took the 48 hour test. However, I am not sure if this then makes a 'test' for PEM rather counter-productive or if it means we should be considering testing over a longer period to really establish the symptom.

As a test of functionality at the time – I can see the test has merit – but as something that is diagnostic of the disease – 'a marker' – I really can't see it myself. Not until bigger and better studies are done.

We did talk about this a lot when the Snell work was published. This need to ensure that patients doing the test were similarly exerting beforehand – maybe even having them on-site as it were the day before to all relax or at least measure and take into account what activity they had performed before testing took place e.g. distances traveled etc.

And of course – as Unger herself says above – such a test is not suitable for all with ME. I sure as heck couldn't do the exercise bike at the moment and I consider myself more able in other respects…

Be back later…

That is a very valid point. My own 2-day test was inconclusive. I even performed a little better the 2nd day. The first day I had not slept very well, and started with acidosis in my legs even before the test. The 2nd day I had had a good night's rest (at least relatively), and no acidosis when I started. I'm sure this affected the results.

And like Els, my PEM usually hits the 2nd day after exertion (so after 48-72 hours).

Also, I had my tests relatively close to home (only one hour of travelling). I was wondering how this is for most US patients, when they have their tests. Do they have to travel far (read exert themselves a great deal) before they are tested? How does that affect the test?

Kati January 31, 2014 at 12:24 pm

Once more the CDC will rely on self-report of pain and other symtoms post exercise test. The only objective value will be the cognitive test, which could in my opinion be skewed whether the patient is upright or reclinng.

when I did my exercise test a couple of ear ago, I developped arrythmia during the test and it was still present the net day.

I can't believe that in 2014 there is no money for patients with ME and for the CDC to perform a truly scientific study on patients who have this poorly researched disease which yanks highly functioning from payroll. This is in the light of President Obama who has announced an extra 100 millions for HIV AIDS only 2months after government shut down last fall.

Basically what the 1day exercise will show is that we are deconditioned. dr Snell and Staci Stevens will confirm that too.

As I am awaiting for being called into doing it, I will ask if I can 'purchase' a day 2 for myself. After a couple of medical reports saying I am refusing 'treatment' of meditation, group therapy and naturopath and yet another specialist who will say that I refuse CBT and GET, I will need to prove that indeed I am sick and doing the very best for myself.

SOC January 31, 2014 at 12:47 pm
Kati

After a couple of medical reports saying I am refusing 'treatment' of meditation, group therapy and naturopath and yet another specialist who will say that I refuse CBT and GET, I will need to prove that indeed I am sick and doing the very best for myself.

What (and where practicing) so-called ME/CFS specialist is using only meditation, group therapy, naturopathy, CBT and GET? Sheesh! :rolleyes: I can see ignorant GPs doing that, but "specialists"? Really? Come on folks, get into the 21st century.

I'm sorry to hear that's the kind of "specialist" treatment you get, Kati. :hug:

heapsreal January 31, 2014 at 6:46 pm

I think it looks promising as they are testing known physiological problems with cfs/me such as the exercise tolerance/pem and the nk function stuff. I guess its not about finding anything new but replicating previous findings. If one day they could add the exercise tolerance test and nk function test to the CCC then i think this will definately be an improvement on diagnosing cfs/me. Im sure there are more tests they could add but this is a good start and its not just going off a list of random symptoms. Once they can narrow the group down to what truly is ME then better studies and treatments hopefully will come.

SOC January 31, 2014 at 7:13 pm

I'm still uncomfortable with the amount of questionnaires compared to objective measures. For a start, questionnaires are only as good as the questions asked. Bad questions give unclear or inaccurate responses. I'm not sure the CDC folks understand the illness well enough to ask appropriate questions. We don't need any more "Have you been overly fatigued in the last 6 months?" Let's hope the expert clinicians and researchers are giving the CDC lots of help with this.

There's the possibility that something positive will come out of this study. The inclusion of our experts is highly encouraging. I won't be comfortable until I see the results, though. :p

Bob January 31, 2014 at 8:09 pm

Here is Dr Unger' s presentation to the IOM committee. It is quite a good over-view of the project but I don't think it includes any new information.

Presentation – click here to view on YouTube.

Q&A's – click here to view on YouTube.

ggingues January 31, 2014 at 8:18 pm
Christopher

Our government is content to just keep slowly doing fruitless studies until we all eventually die out. Why bother caring?

The only time the feds gave us any attention is when researchers started getting too close to the truth. It was only THEN that they decided to spend money to shut us up and move the illness to that of "autoimmunity" and "inflammation of unknown etiology" – just enough research to placate patients but not enough to get anywhere with treatment. And what, we should be overjoyed that after decades of willfully neglecting physiological research into our disease that we're finally getting some crumbs?

We're not going to get anywhere with this ass-covering bullcrap. Why we tolerate this abuse by our government I do not understand.

(deep breaths, Chris, deep breaths)

@Christopher Couldn't agree with you more! Ready to burn this sucker down!!

GG

Firestormm February 1, 2014 at 3:48 am

Well, it makes a marvelous difference to watch and listen to a presentation from IOM that is not subject to problems with internet signal, or sound, I must say! Struggling to watch the IOM meeting the other night (day 1), led I believe to my subsequent issues experienced (day 3). Talk about PEM :ill:.

And that wasn't unusual physical exertion of course: which brings me to another point about the CPET – it is stimulated by physical and not mental exertion: so we also need some means of measuring objective mental exertion and any affect or influence it has on PEM as a symptom (if indeed following all of these attempts to determine what PEM might be, it continues to exist as a separate symptom).

If I over-exert mentally, to a significant extent, on Day 1, and don't rest on Day 2 but try and continue my normal routines (which include mental 'work'), then on Day 3 I will feel bad effects. Is this any different to physical exertions, and physical PEM? It may well be but perhaps we need to learn more about it. And what about the combination of physical and mental over-exertion?

We are also no closer to determining a cause. There have been hints, but if looking at physical exertion – over and above 'a norm' – then why should we feel 'worse' after a delay? And why should that delay be different (perhaps) for each of us – could it be based on the nature and/or duration of the exertion? The 'level' of our individual disability? What factors might contribute to delaying any negative effects? And do those effects occur all the time i.e. what is the actual trigger – is there a 'level' at which an 'event' is triggered?

I took a long time – 1-2 years – to build up to the routine I have now and baring exceptions like the flu, I can manage to do what I need to do at the level of functioning I now experience generally. But any interuption to that routine – like viewing the IOM conference the other night (which ran from 6-10pm UK Time) and was well outside of my routine – tends to screw me over but to variable degrees.

I find it easier to pace any over-exertion on the physical front and find it easier to manage than mental exertion, but whilst I do anticipate a 'crash', I don't avoid overdoing things but instead try and plan for them. It's the unexpected or unintended events now that catch me out – or the unavoidable. Also I experience terrible sleep, and an especially 'bad night' will f**** me up in similar fashion to a bout of PEM, but it occurs almost immediately.

I think unraveling PEM has a way to go, but I am pleased that they seem to be trying to get to grips with it – at least in part. Always was too loose a symptom for me – and for my doctors – to really place much faith in. One of the hardest I found to make others believe is real: 'Well, we all feel bad the next day, after doing too much the day before." Etc. etc. So I do hope that this CPET when properly validated can help alleviate some of this concern: though quite how practical it will be as a test in a surgery – or when it might be used – I don't know.

It bothers me that as a 'test' it implies that at some point a level of 'pass/fail' might be employed. And what if you 'fail' at the time of taking it? ME is a fluctuating condition. I also can't help but worry, that such a test could be used by some unscrupulous Benefit Agency as a determinant for work capability…

OK that might be wholly unrealistic, but at some point when tests become the norm for our condition (whatever that proves to be), and the results feature in medical records, then it will filter into our assessed ability to work. Might be a good thing, might not. I can't help worrying though – especially if people are overly praising of such things before they have been properly validated.

daisybell February 1, 2014 at 6:37 pm
Firestormm

Well, it makes a marvelous difference to watch and listen to a presentation from IOM that is not subject to problems with internet signal, or sound, I must say! Struggling to watch the IOM meeting the other night (day 1), led I believe to my subsequent issues experienced (day 3). Talk about PEM :ill:.

And that wasn't unusual physical exertion of course: which brings me to another point about the CPET – it is stimulated by physical and not mental exertion: so we also need some means of measuring objective mental exertion and any affect or influence it has on PEM as a symptom (if indeed following all of these attempts to determine what PEM might be, it continues to exist as a separate symptom).

If I over-exert mentally, to a significant extent, on Day 1, and don't rest on Day 2 but try and continue my normal routines (which include mental 'work'), then on Day 3 I will feel bad effects. Is this any different to physical exertions, and physical PEM? It may well be but perhaps we need to learn more about it. And what about the combination of physical and mental over-exertion?

We are also no closer to determining a cause. There have been hints, but if looking at physical exertion – over and above 'a norm' – then why should we feel 'worse' after a delay? And why should that delay be different (perhaps) for each of us – could it be based on the nature and/or duration of the exertion? The 'level' of our individual disability? What factors might contribute to delaying any negative effects? And do those effects occur all the time i.e. what is the actual trigger – is there a 'level' at which an 'event' is triggered?

I took a long time – 1-2 years – to build up to the routine I have now and baring exceptions like the flu, I can manage to do what I need to do at the level of functioning I now experience generally. But any interuption to that routine – like viewing the IOM conference the other night (which ran from 6-10pm UK Time) and was well outside of my routine – tends to screw me over but to variable degrees.

I find it easier to pace any over-exertion on the physical front and find it easier to manage than mental exertion, but whilst I do anticipate a 'crash', I don't avoid overdoing things but instead try and plan for them. It's the unexpected or unintended events now that catch me out – or the unavoidable. Also I experience terrible sleep, and an especially 'bad night' will f**** me up in similar fashion to a bout of PEM, but it occurs almost immediately.

I think unraveling PEM has a way to go, but I am pleased that they seem to be trying to get to grips with it – at least in part. Always was too loose a symptom for me – and for my doctors – to really place much faith in. One of the hardest I found to make others believe is real: 'Well, we all feel bad the next day, after doing too much the day before." Etc. etc. So I do hope that this CPET when properly validated can help alleviate some of this concern: though quite how practical it will be as a test in a surgery – or when it might be used – I don't know.

It bothers me that as a 'test' it implies that at some point a level of 'pass/fail' might be employed. And what if you 'fail' at the time of taking it? ME is a fluctuating condition. I also can't help but worry, that such a test could be used by some unscrupulous Benefit Agency as a determinant for work capability…

OK that might be wholly unrealistic, but at some point when tests become the norm for our condition (whatever that proves to be), and the results feature in medical records, then it will filter into our assessed ability to work. Might be a good thing, might not. I can't help worrying though – especially if people are overly praising of such things before they have been properly validated.

I agree with you. I find that mental exertion is in some ways worse than physical for making me feel unwell. If I am having a good spell, I can walk for over an hour (slowly) with no apparent after-effects. I recently had two weeks off work and felt great! ( that is to say I actually didn't wake up every day feeling unwell) But as soon as I am back at work which I am still trying to do, I feel unwell again. The sustained cognitive load is what seems to bring on most of my symptoms.
If I end up not working, I can't see any dr without significant experience of ME concluding that I am not fit for work. But as soon as I work, I feel ill.

5150 February 1, 2014 at 8:45 pm
Christopher

Our government is content to just keep slowly doing fruitless studies until we all eventually die out. Why bother caring?

The only time the feds gave us any attention is when researchers started getting too close to the truth. It was only THEN that they decided to spend money to shut us up and move the illness to that of "autoimmunity" and "inflammation of unknown etiology" – just enough research to placate patients but not enough to get anywhere with treatment. And what, we should be overjoyed that after decades of willfully neglecting physiological research into our disease that we're finally getting some crumbs?

We're not going to get anywhere with this ass-covering bullcrap. Why we tolerate this abuse by our government I do not understand.

(deep breaths, Chris, deep breaths)

We Need To Find The Root Cause(s). We Need Treatments. We Don't Need Leftover Crumbs Studies.
Unger and Sebelius: what a pair to draw. More Stonewalling.

biophile February 1, 2014 at 9:41 pm

Thanks Bob. I have not combed over the article yet, but the lack of 2-day testing annoyed me more than I thought it would. I understand many patients cannot do this test, I would be very reluctant to do it because of my current state (I would have been glad to do it in the earlier less-severe years of the illness), but the option should be there for a subgroup. Researchers behind the CPET test for CFS are saying there needs to be a two day test for the best data.

Subjective questionnaires are important, and we do need large studies employing them, but part of me cannot help but see the CDC multi-site study as the sort of preliminary fluffery that should have already been done 20 years ago. So some important data should be collected, but more of the same, and a great opportunity lost, sort of like the PACE Trial adding on a whole bunch of questionnaires but then omitting one of the most important measures i.e. actigraphy by actometers.

I think don't think a single CPET test is going to be utterly useless though. Many patients are worried that a single test will just serve an agenda to show that patients are merely deconditioned. However, what a single day test does show is that CFS patients can have similar fitness levels as healthy sedentary controls who do not experience CFS symptoms or PEM. That in itself is a convincing argument against the primary deconditioning hypothesis.

Simon mentioned that the Lights found (biological) abnormalities corresponding to PEM after a single test. Unfortunately, the CDC multi-site study is not taking any blood samples after the exercise test either? It appears however that the methodology can be added to if there is adequate funding. So it sounds like there is hope that the CDC may not (but probably will anyway) miss a great opportunity to validate some previous clues.

Bob February 1, 2014 at 10:09 pm
biophile

…part of me cannot help but see the CDC multi-site study as the sort of preliminary fluffery that should have already been done 20 years ago.

Yes, I agree. This study should have been carried out 20 or 30 years ago. The way I see it is that the CDC has done next to nothing in the past, in terms of useful research. So the CDC doesn't have any useful data on ME. I think Beth Unger is starting afresh. She has to start somewhere, and I think this is a good place to start. Unfortunately it's 20 or 30 years too late, but that's not her fault. She has emphasised, repeatedly, that this is only a starting point, and that the study will evolve. But no one trusts the CDC, so they need to demonstrate their intentions with actions. But even purely using self-reports, and clinical history (inc vaccination history, and past/current pharmaceutical prescriptions), I think a large study like this may potentially give some exceptional ground-breaking info.

biophile

I think don't think a single CPET test is going to be utterly useless though. Many patients are worried that a single test will just serve an agenda to show that patients are merely deconditioned. However, what a single day test does show is that CFS patients can have similar fitness levels as healthy sedentary controls who do not experience CFS symptoms or PEM. That in itself is a convincing argument against the primary deconditioning hypothesis.

A single CPET study on it's own is going to be pretty useless, I imagine, although it may contribute to determining some subsets. But I think the 48 hour post-exertional cognitive tests and self-reports may well have some merit, and may well come up with some interesting results. The reason a two-day CPET test is informative is because the second test assesses and objectively measures the post-exertion reaction. But 48 hour post-exertional cognitive tests may also measure PEM (i.e. changes as a result of a post-exertional reaction.)

biophile

Unfortunately, the CDC multi-site study is not taking any blood samples after the exercise test either?

I don't think they are taking post-exertional blood samples. I haven't seen that proposed.

biophile

It appears however that the methodology can be added to if there is adequate funding. So it sounds like there is hope that the CDC may not (but probably will anyway) miss a great opportunity to validate some previous clues.

It all boils down to whether Unger is honest, open-minded and competent.
I'm hopeful that she's doing her job with good faith, but the CDC has a lot to prove.
I think that Unger may have reset the CDC's program for CFS, which is what she needed to do.
And if starting from scratch, I can't fault her approach of collecting large amounts of data and 'following the evidence' (i.e. without bias or prejudice), which I think is exactly what we need.

But, yes, if she adds objective biomedical tests, then the study could be transformed into something incredibly meaningful and ground-breaking, if carried out competently and honestly.

I'm cautiously optimistic, but I'll be sceptical until we see some meaningful results, and a solid demonstration of good faith.

heapsreal February 1, 2014 at 11:12 pm

i think the good research is going to come from the private type researchers like kdm, montoya, dr K, dr P, need the $$ to go to those guys to get the job done.

Firestormm February 2, 2014 at 2:41 am

I wonder if the following examination were to be repeated on patients with ME similar observations might be made (PEM in Gulf War Illness) June 2013:

Exercise Challenge in Gulf War Illness Reveals Two Subgroups with Altered Brain Structure and Function

Abstract

A hallmark complaint of subjects with Gulf War Illness is post-exertional malaise; defined as an exacerbation of symptoms following physical and/or mental effort.

To study the causal relationship between exercise, the brain, and changes in symptoms, 28 Gulf War veterans and 10 controls completed an fMRI scan before and after two exercise stress tests to investigate serial changes in pain, autonomic function, and working memory.

Exercise induced two clinical Gulf War Illness subgroups. One subgroup presented with orthostatic tachycardia (n = 10). This phenotype correlated with brainstem atrophy, baseline working memory compensation in the cerebellar vermis, and subsequent loss of compensation after exercise.

The other subgroup developed exercise induced hyperalgesia (n = 18) that was associated with cortical atrophy and baseline working memory compensation in the basal ganglia. Alterations in cognition, brain structure, and symptoms were absent in controls.

Our novel findings may provide an understanding of the relationship between the brain and post-exertional malaise in Gulf War Illness.

Introduction

…The effects of 2 bicycle exercise stress tests performed on consecutive days on widespread pain (hyperalgesia), autonomic regulation, and working memory function were studied in 10 controls and 28 Gulf War veterans who met the 1998 CDC case definition criteria for GWI over a four day period [4]….

Not that I am saying this research was good or bad, obviously is in need of replication; but apart from the observed sub-groupings, it is I think important to note that PEM is not exclusive to ME. Maybe they should also try Snell's testing methods on GWI and also use controls from other chronic conditions (I know Snell has said that his observation in ME was unique but a study using, say, MS patients as well as healthy people, as controls, might also better enable the point from his initial research to be better established as something definitive for ME).

Firestormm February 2, 2014 at 2:59 am
heapsreal

i think the good research is going to come from the private type researchers like kdm, montoya, dr K, dr P, need the $$ to go to those guys to get the job done.

I agree, in part, but would like to see more of them joining together, providing samples, as some of them did for the Lipkin study, for example. There seems little doubt now that those more familiar with our condition will be the ones to carry out the research – will less funding coming from Govt. sources: but they MUST by joining together do these studies on significant numbers of patients.

I really can't put into words how much I loathe seeing small studies be produced that appear 'interesting' and then never get replicated. I think our condition has had more than enough of these 'pilots' and it's time to really begin replication and/or large powered studies that will negate spurious hypotheses from the past that have been borne on such pilots, or will move the science forward recognisably.

There is also something to be said I think for being a little cautious in believing a study 'good' because a known 'expert' is behind it. I would like more openness with respect to protocols, and peer-review, as part of or prior to any public effort to raise funds. But when push comes to shove, I would rather see researchers doing it privately, than not doing it at all. And times have definitely changed – we can't rely (not that we could) on Govt. funding for science – and in that I don't think we are much different than in other illnesses – though the $ spent are of course proportionately less.

heapsreal February 2, 2014 at 3:01 am

@Firestormm i guess its bound to happen in other disorders, but its not something that has been tested in other conditions. It does show disability though.

heapsreal February 2, 2014 at 3:05 am
Firestormm

I agree, in part, but would like to see more of them joining together, providing samples, as some of them did for the Lipkin study. There seems little doubt now that those more familiar with our condition will be the ones to carry out the research – will less funding coming from Govt. sources: but they MUST by joining together do these studies on significant numbers of patients. I really can't put into words how much I loathe seeing small studies be produced that appear 'interesting' and then never get replicated. I think our condition has had more than enough of these 'pilots' and it's time to really begin replication and/or large powered studies that will negate spurious hypotheses from the past that have been borne on such pilots, or will move the science forward recognisably.

hopefully if these private guys come up with something then they might get more govt research dollars. The aussie researchers Peterson is working with at griffith uni are getting reasonable govt grants here, its not in the cancer range $$ but its more then they have done in the past. When issues start arising and being replicated then the govt are going to have to act.

Firestormm February 2, 2014 at 3:07 am
heapsreal

hopefully if these private guys come up with something then they might get more govt research dollars. The aussie researchers Peterson is working with at griffith uni are getting reasonable govt grants here, its not in the cancer range $$ but its more then they have done in the past. When issues start arising and being replicated then the govt are going to have to act.

That is reassuring news, Heaps :)

I wonder what the breakdown of expenditure are for this CDC Multi-site, IOM (well we know is $1m), and NIH P2P? Combined they must amount to a fair whack I guess.

Christopher February 2, 2014 at 5:45 am
Bob

She says she's 'following the evidence' (i.e. without bias or prejudice), which I think is exactly what we need.

They already have all the evidence they need to push for fast tracking certain treatments. Ignoring decades worth of biomarkers related to inflammation and immune dysfunction as well as successful treatment trials (ampligen, rituximab) already shows bias and prejudice.

We already have the data we need to start addressing treatment. They are content to poke and prod us as we keep suffering. We have to stop allowing the abuse and neglect to continue.

Christopher February 2, 2014 at 5:46 am
Firestormm

That is reassuring news, Heaps :)

I wonder what the breakdown of expenditure are for this CDC Multi-site, IOM (well we know is $1m), and NIH P2P? Combined they must amount to a fair whack I guess.

Pennies when we need dollars, Firestorm. Pennies.

Valentijn February 2, 2014 at 10:06 am
Firestormm

Not that I am saying this research was good or bad, obviously is in need of replication; but apart from the observed sub-groupings, it is I think important to note that PEM is not exclusive to ME. Maybe they should also try Snell's testing methods on GWI and also use controls from other chronic conditions (I know Snell has said that his observation in ME was unique but a study using, say, MS patients as well as healthy people, as controls, might also better enable the point from his initial research to be better established as something definitive for ME).

GWI is a pretty bad example to use to show that PEM is not unique to ME/CFS … the symptoms of the two conditions overlap completely, to the extent that they might very well be the same disease, or subsets of the same disease. The only real difference is that GWI includes a group defined by their career, which isn't actually relevant to who a disease decides to pick on.

Most likely, they have ME/CFS, but have a very specific pathway into getting it: military vaccinations, certain chemical exposures, etc. But that fits pretty well with the ME/CFS concept of the disease being triggered by different types of infections, vaccine reactions, and exposures to chemicals such as organophosphates.

roonie February 2, 2014 at 10:12 am

has anyone ever seen a government do any good for it people…..ever. One look at the lyme fiasco should tell us all to pick the fight up to a new level. We need protests so the rest of the world see us on the news..not hiding in a back corner watching the lives of ours and, in many cases , our families fall to pieces.

Why did they want to keep changing the name of the illness every few years….its to keep us all confussed…..thats why. To keep the new patients devided from the old ones. Im with Christopher on this one! They have something to hide. Its quite possible they already know what this illness is. People …get ready. Did you see Nelson Mendella sit back on his Laurells

jimells February 2, 2014 at 10:29 am

This "study" is a cruel joke. I'm going to apply for a grant to study fevers. I'll ask a bunch of folks if they think they might have a fever. That will qualify them for the study. Then I'll ask them how hot and sweaty they feel.

Thermometers will not be allowed – they are just too much trouble, what with the cost, and sterilizing, and having to read them.

Unger and her ilk are guilty of criminal negligence, but we are the ones serving a life (or death) sentence.

Ember February 2, 2014 at 5:04 pm

Dr. Unger writes that “a new definition of CFS is not the objective of this study.” But in November 2011 she described this study as preparatory to a meeting of experts charged with revisiting Fukuda 1994:

Going by what has happened at CDC in the past, we will next convene a meeting of experts. CDC does not decide any of this on its own. That is why I always say it is not CDC’s definition. For good, bad, or indifferent, just like in the ACIP [Advisory Committee on Immunization Practices], CDC implements what the committees and the recommendations are. That is how the 1994 case definition got established. 1994 is long enough ago that everyone agrees it definitely needs to be revisited.

It will be most helpful when we actually have some data to guide that discussion. Given that we are at the beginning of the contract and we are just beginning to collect the data, if all goes well, we hope that we will have the data in a one‐year time frame. We can anticipate that it will be at least one year before we could start the dialog in the process.

Learning from other consensus‐building organizations that I have been involved in, you have a meeting, but you need to have committees and upfront discussion and dialog before the meeting. You have things posted for comment, dialog, and discussion. Everybody needs to have a voice in what the final product is.

What has become of Dr. Unger's plan to revisit Fukuda 1994?

Bob February 2, 2014 at 7:54 pm
Ember

What has become of Dr. Unger's plan to revisit Fukuda 1994?

I don't know, but perhaps she realised that the evidence base was woefully inadequate, and decided instead to embark on a large evidence collecting program? The proposed 'one year' study has turned into a large five year study. Although Unger says that the specific aim of the CDC study is not to create a new diagnostic criteria, I hope that is the direction where it is ultimately heading, in practice. (Assuming that Unger is working in good faith, and competently etc.) Unger is looking for evidence to distinguish patients from controls (i.e. healthy controls and patients with other fatiguing illnesses), and for evidence to create subgroups, and for evidence that can be used to diagnose patients.

If Unger isn't sticking to her previous ideas (as quoted in Ember's post above), then I think it's probably a very good thing based on this extract from Ember's quote:

Going by what has happened at CDC in the past, we will next convene a meeting of experts.

Both halves of that sentence, coming from the CDC, is enough to send ice cold shivers up the spine of any ME patient!

Ember February 3, 2014 at 6:24 am
Bob

(Assuming that Unger is working in good faith, and competently etc.) Unger is looking for evidence to distinguish patients from controls (i.e. healthy controls and patients with other fatiguing illnesses), and for evidence to create subgroups, and for evidence that can be used to diagnose patients.

Those aren't assumptions that I can make given that Dr. Unger refuses to use the 2-day CPET or even to disclose whether or not her cohort meets Fukuda or the CCC. She admits that the data are there but contends, “It still, I think, requires some interpretation and discussion.” Those apparently aren't her strong suits.

Dr. Unger's so-called study looks to me more like an extended fishing expedition. She concluded her comments to the IOM smiling coyly, “So we're just starting. Just a start.” After 20 years, the ICC and CCC languish, and no initiative has been undertaken to replace the CDC's 1994 research definition. Patients are left to suffer or die.

Christopher February 3, 2014 at 6:32 am
Ember

Those aren't assumptions that I can make given that Dr. Unger refuses to use the 2-day CPET or even to disclose whether or not her cohort meets Fukuda or the CCC. She admits that the data are there but contends, “It still, I think, requires some interpretation and discussion.” Those apparently aren't her strong suits.

Dr. Unger's so-called study looks to me more like an extended fishing expedition. She concluded her comments to the IOM smiling coyly, “So we're just starting. Just a start.” After 20 years, the ICC and CCC languish, and no initiative has been undertaken to replace the CDC's 1994 research definition. Patients are left to suffer or die.

This is an alternate version of the AIDS crisis where no one demanded that the federal government help its citizens.

Marco February 3, 2014 at 10:43 am
Valentijn
Firestormm

Not that I am saying this research was good or bad, obviously is in need of replication; but apart from the observed sub-groupings, it is I think important to note that PEM is not exclusive to ME. Maybe they should also try Snell's testing methods on GWI and also use controls from other chronic conditions (I know Snell has said that his observation in ME was unique but a study using, say, MS patients as well as healthy people, as controls, might also better enable the point from his initial research to be better established as something definitive for ME).

GWI is a pretty bad example to use to show that PEM is not unique to ME/CFS … the symptoms of the two conditions overlap completely, to the extent that they might very well be the same disease, or subsets of the same disease. The only real difference is that GWI includes a group defined by their career, which isn't actually relevant to who a disease decides to pick on.

Most likely, they have ME/CFS, but have a very specific pathway into getting it: military vaccinations, certain chemical exposures, etc. But that fits pretty well with the ME/CFS concept of the disease being triggered by different types of infections, vaccine reactions, and exposures to chemicals such as organophosphates.

PEM can also be found in post-concussion syndrome which makes it a bit of a stretch to blame infection, vaccinations or chemical exposure solely (looks to me like the problem is in the brain) :

http://www.ncbi.nlm.nih.gov/pubmed/23252441

Probably not a good idea to mention graded exercise :

http://www.hindawi.com/journals/rerp/2012/705309/

Firestormm February 3, 2014 at 10:45 am

@Marco Ta matey. I shall have a butcher's later :)

Valentijn February 3, 2014 at 11:22 am
Marco

PEM can also be found in post-concussion syndrome which makes it a bit of a stretch to blame infection, vaccinations or chemical exposure solely (looks to me like the problem is in the brain) :

http://www.ncbi.nlm.nih.gov/pubmed/23252441

Probably not a good idea to mention graded exercise :

http://www.hindawi.com/journals/rerp/2012/705309/

That doesn't sound like PEM, as it's limited to cognitive abilities and seems to be immediately after activity, not a day or two later. Duration of cognitive impairment is also not specified – so it's quite a stretch to equate the results of that study with PEM.

And the 2nd link is specifically referring to symptoms during an exercise test, not afterward. Hence it really sounds like exercise intolerance rather than PEM.

Bob February 3, 2014 at 11:30 am
Valentijn

That doesn't sound like PEM, as it's limited to cognitive abilities and seems to be immediately after activity, not a day or two later. Duration of cognitive impairment is also not specified – so it's quite a stretch to equate the results of that study with PEM.

And the 2nd link is specifically referring to symptoms during an exercise test, not afterward. Hence it really sounds like exercise intolerance rather than PEM.

Yes, it's important to always remember that PEM in ME has a distinct nature. It's not just post-exertional malaise, and it's not just post-exertional fatigue. It's a delayed post-exertional exacerbation of any/all ME symptoms, in response to even minimal exertion, that isn't resolved by ordinary rest, etc.

We have to define PEM in ME before comparing it to other diseases which feature post-exertional symptoms.

Bob February 3, 2014 at 11:49 am
Bob

Assuming that Unger is working in good faith, and competently etc.

Ember

Those aren't assumptions that I can make…

I agree that the CDC has to prove itself.
I'm watching what they are doing with an open mind: sceptical but not judging Unger by the past failings of the CDC.

If I was Beth Unger, I might be start exactly where she is starting.
I'd be pressing a reset button, and re-starting the CDC's CFS program from scratch with a large study using patients from the clinics of widely acknowledged ME expert clinicians.
And I'd want to follow the data.
Yes, we desperately need objective biomedical investigations, but (in my opinion) she's got to start with basic data collection which should have been done 20 years ago.
She's made it clear that her data is intended to be used for future biomedical investigations.

Ember

…given that Dr. Unger refuses to [...] disclose whether or not her cohort meets Fukuda or the CCC. She admits that the data are there but contends, “It still, I think, requires some interpretation and discussion.” Those apparently aren't her strong suits.

Yes, she doesn't seem to be good at discussion.

The study did not recruit participants using either Fukuda or CCC, so perhaps they are a mixed cohort.
I suspect that they will probably mostly meet Fukuda, and perhaps the majority will also meet the CCC, because they come from secondary care clinics (suggesting long-term and more severe symptoms).
But I think that Unger is right not to focus on these criteria.
She is investigating the data from all ME/CFS patients diagnosed by expert clinicians.
Hopefully she will be using diagnostic criteria, at part of the study, but that shouldn't be the focus.

The focus should be on finding subsets based on the data, and then seeing if these match the existing diagnostic criteria or not.
It would be a shallow and ill-conceived project if Unger was purely attempting to match her data to existing diagnostic criteria.
For it to be meaningful, and ground-breaking, she's got to assess the data with an open mind, looking for unexpected patterns in the data and attempting to define subgroups based on the data and not on pre-existing (consensus) diagnostic criteria.

If the data matches the existing diagnostic criteria then that will be a very useful finding. But it might not.

Ember

Dr. Unger's so-called study looks to me more like an extended fishing expedition.

I think I agree with that. That's what I want her to be doing. Fishing for all the data she can, and analysing it.
Yes, she must move on to including comprehensive biomedical testing, and I hope she will, quickly.
If she doesn't then the trust of the patient community will not be gained.
At the moment there is zero trust.

Anyway, these are just my own opinions. I know that many don't agree.

JKN February 3, 2014 at 3:31 pm

I feel like a stranger in a strange land with all of this talk about the CPET test. I took a cardiac stress test 9 years ago which cause very severe disease progression and heart damage. I am now in diastolic heart failure as a result of this stress test. I also lost my ability to talk.

"Findings which suggest mitochondrial metabolic dysfunction similar to mitochondrial encephalomyopathy in CFS patients led CFS expert Professor Paul Cheney to comment. ‘The most important thing about exercise is not to have patients do aerobic exercise. I believe that even progressive aerobic exercise is counter-productive. If you have a defect in mitochondrial function and you push the mitochondria by exercise, you kill the DNA.’ Numerous heart, lung, brain and other abnormalities also show strong evidence that exercise can have extremely harmful effects on CFS patients in many different bodily systems, permanent damage may be caused, as well as disease progression." (Williams 2004, [online]).

"Not only is it inappropriate for CFS patients to undergo a treadmill stress test or be pushed toward age-predicted target heart rates, but this is potentially dangerous." Philipa Corning, Ph D, Vice President Quest 61, 2003

Dr. Paul Cheney wrote (www.cheneyresearch.com), "We have a rising case load of diastolic dysfunction seen in 97% of our CFS cases (avg. age 49) and some appear to have what I would call compensated diastolic heart failure. I would define compensated DHF in CFS as an extremely low cardiac output with a cardiac index (CI) below 2.0 and very poor functional capacity combined with the inability to stand which is the corollary in DHF to the inability to lay down flat in systolic heart failure (SHF). Heart failure patients are typically below 2.0 in CI. I have several CFS patients below that number and they cannot stand still for more than 15-30 seconds without having to sit down or fall down. Walking or moving helps which makes sense as that would increase filling pressures and equivalent to laying down. They might be diagnosed as having orthostatic intolerance by others."

"Recently, Jason et al (2006) reported that the mean age of patients with myalgic encephalomyelitis/chronic fatigue syndrome dying from heart failure, i.e. 58.7 years, is significantly lower than the age of those dying from heart failure in the general US population, i.e. 83.1 years."

So I am totally shocked by these exercise tests going on. Unless, I have a different disease, which I don't believe I do, or that there is a difference between ME and CFS, then I don't understand why PWCs taking this cardio test aren't having the same horrific results that I've had. If these tests expand in this study, and PWCs aren't warned of the possible results of severe permanent disease progression, then I fear what might happen to some patients.

Furthermore, I don't understand why there are no research studies going on today reg. the effects that ME/CFS has on the heart, i.e. this is one of the main causes of death from ME/CFS.

When I look at the current research most of it seem irrelevent to me. None of it is going to save my life.

So I just wanted to put out this warning for PWCs taking these cardio stress tests, because there seems to be no serious warning out there. I don't think most ME/CFS doctors understand the possible consequences.

SOC February 3, 2014 at 5:27 pm
Bob

I agree that the CDC has to prove itself.
I'm watching what they are doing with an open mind: sceptical but not judging Unger by the past failings of the CDC.

If I was Beth Unger, I might be start exactly where she is starting.
I'd be pressing a reset button, and re-starting the CDC's CFS program from scratch with a large study using patients from the clinics of widely acknowledged ME expert clinicians.
And I'd want to follow the data.

I understand that point — that Dr Unger may understand that the CDC needs to start over with it's view of ME/CFS. What frustrates me is that she seems to think that only the CDC can do valid research on ME/CFS and therefore their research must start at absolute ground zero. No respect for the work already done by many talented researchers. It seems she feels the need to reinvent the wheel of ME/CFS knowledge.

We don't have time for the CDC to mess around for 20 years getting up to speed doing their own research to find out what we already know.

That said, the CDC is (technically) not a medical research organization, they're a public health organization. Original research should be coming out of other branches of HHS. So maybe the focus on operation… rationalizing… whatever that word is :confused:… diagnosis makes sense in terms of their particular responsibility. They're not focused on figuring out what's wrong with us, or how to treat it, just telling doctors how to know who has it. Kinda pointless given we don't have any established treatment even if we're diagnosed. :meh:

It would (supposedly) allow them to study how big of a problem ME/CFS is, which is definitely part of their public health remit, so the current research may give them some future work. Which, of course, is a benefit to them even if it isn't much help to us. :rolleyes:

Ember February 3, 2014 at 5:48 pm
Bob

For it to be meaningful, and ground-breaking, she's got to assess the data with an open mind, looking for unexpected patterns in the data and attempting to define subgroups based on the data and not on pre-existing (consensus) diagnostic criteria.

Subgroups presuppose groups, and identifying them may not be ground-breaking:

Optional Considerations

Classifying patients by subgroups to enable the comparison of patients within the diagnosis of ME may be helpful in some studies.

1 Onset: acute infectious or gradual.
2 Onset severity may be a good predictor of severity in the chronic phase.
3 Symptom severity: mild, moderate, severe, very severe.
4 Criterial subgroups: neurological, immune, energy metabolism/transport or eclectic.

By insisting that Dr. Unger "assess data with an open mind, looking for unexpected patterns," are you denigrating the time-honoured practice of hypothesis testing?

SOC February 3, 2014 at 6:12 pm
JKN

I feel like a stranger in a strange land with all of this talk about the CPET test. I took a cardiac stress test 9 years ago which cause very severe disease progression and heart damage. I am now in diastolic heart failure as a result of this stress test. I also lost my ability to talk.

"Findings which suggest mitochondrial metabolic dysfunction similar to mitochondrial encephalomyopathy in CFS patients led CFS expert Professor Paul Cheney to comment. ‘The most important thing about exercise is not to have patients do aerobic exercise. I believe that even progressive aerobic exercise is counter-productive. If you have a defect in mitochondrial function and you push the mitochondria by exercise, you kill the DNA.’ Numerous heart, lung, brain and other abnormalities also show strong evidence that exercise can have extremely harmful effects on CFS patients in many different bodily systems, permanent damage may be caused, as well as disease progression." (Williams 2004, [online]).

"Not only is it inappropriate for CFS patients to undergo a treadmill stress test or be pushed toward age-predicted target heart rates, but this is potentially dangerous." Philipa Corning, Ph D, Vice President Quest 61, 2003

Dr. Paul Cheney wrote (http://www.cheneyresearch.com), "We have a rising case load of diastolic dysfunction seen in 97% of our CFS cases (avg. age 49) and some appear to have what I would call compensated diastolic heart failure. I would define compensated DHF in CFS as an extremely low cardiac output with a cardiac index (CI) below 2.0 and very poor functional capacity combined with the inability to stand which is the corollary in DHF to the inability to lay down flat in systolic heart failure (SHF). Heart failure patients are typically below 2.0 in CI. I have several CFS patients below that number and they cannot stand still for more than 15-30 seconds without having to sit down or fall down. Walking or moving helps which makes sense as that would increase filling pressures and equivalent to laying down. They might be diagnosed as having orthostatic intolerance by others."

"Recently, Jason et al (2006) reported that the mean age of patients with myalgic encephalomyelitis/chronic fatigue syndrome dying from heart failure, i.e. 58.7 years, is significantly lower than the age of those dying from heart failure in the general US population, i.e. 83.1 years."

So I am totally shocked by these exercise tests going on. Unless, I have a different disease, which I don't believe I do, or that there is a difference between ME and CFS, then I don't understand why PWCs taking this cardio test aren't having the same horrific results that I've had. If these tests expand in this study, and PWCs aren't warned of the possible results of severe permanent disease progression, then I fear what might happen to some patients.

Furthermore, I don't understand why there are no research studies going on today reg. the effects that ME/CFS has on the heart, i.e. this is one of the main causes of death from ME/CFS.

When I look at the current research most of it seem irrelevent to me. None of it is going to save my life.

So I just wanted to put out this warning for PWCs taking these cardio stress tests, because there seems to be no serious warning out there. I don't think most ME/CFS doctors understand the possible consequences.

The CPET test is not the same test as the walking cardiac stress test.

The CPET is done on a bicycle, not a treadmill. The bicycle does not force a particular speed on the patient the way a treadmill does. The cardiac stress test only records EKG and BP. The CPET also includes pulmonary gases, so the tester knows when the patient has reached his/her anaerobic threshold and can adjust the test accordingly so as not to severely overwork the patient. The cardiac stress test has all patients exercising at the same speed and incline, healthy or ill. That can be a serious problem with PWME. The CPET (properly performed for PWME) allows for adjustment of work depending on the capability of the patient.

I suspect that the CPET test (properly done for PWME) is not as severe as many PWME fear. I've done it (the one day test) twice now and neither time was it as terrible as I expected. Both times it was done in the office of an ME/CFS specialist by people who understand the illness. The test ran about 8 minutes. The pedaling resistance was set so easy that it was like waving my legs around, not pushing with any power at all. I didn't feel great afterwards, but I didn't have a massive crash, either.

I do not have mild ME/CFS. I'm about 5/10 on most scales. I couldn't walk more than 100 ft without PEM the last time I did the test, so it's not like I'm not susceptible to PEM or have a high threshold for PEM.

I'm not saying the test is trivial for all PWME. I think many of us have some (relatively small) consequence such as several days to a week of moderate PEM, but not a long-term crash. It's important to note that it is NOT the same test as the cardiac stress test most people imagine, which would probably seriously crash most of us, especially when done by technicians unfamiliar with the limitations of PWME.

Bob February 3, 2014 at 6:49 pm
Ember

Subgroups presuppose groups, and identifying them may not be ground-breaking:

Optional Considerations

Classifying patients by subgroups to enable the comparison of patients within the diagnosis of ME may be helpful in some studies.

1 Onset: acute infectious or gradual.
2 Onset severity may be a good predictor of severity in the chronic phase.
3 Symptom severity: mild, moderate, severe, very severe.
4 Criterial subgroups: neurological, immune, energy metabolism/transport or eclectic.

I think there's a wide consensus that CFS and CFS/ME are heterogeneious, and that ME might be heterogenous.
I personally think it's absolutley essential to use data to attempt to identify subgroups, in order for research to advance.

Yes, there are various subgroups that are already defined, but Unger is carrying out a massive data analysis, and perhaps she may find unexpected groups, based on the data. I hope she is cross-referencing with already-defined subgroups, such as the ones you've identified here.

Ember

By insisting that Dr. Unger "assess data with an open mind, looking for unexpected patterns," are you denigrating the time-honoured practice of hypothesis testing?

I think it would be narrow minded if the only hypothesis being tested was whether patients fit into currently defined diagnostic criteria. I hope that Unger is testing the collected data against Fukuda and the CCC/ICC. But I think many of us agree that CCC and ICC, although vastly preferable to Fukuda, are not set in stone.

Bob February 3, 2014 at 6:59 pm
SOC

The CPET test is not the same test as the walking cardiac stress test.

The CPET is done on a bicycle, not a treadmill. The bicycle does not force a particular speed on the patient the way a treadmill does. The cardiac stress test only records EKG and BP. The CPET also includes pulmonary gases, so the tester knows when the patient has reached his/her anaerobic threshold and can adjust the test accordingly so as not to severely overwork the patient. The cardiac stress test has all patients exercising at the same speed and incline, healthy or ill. That can be a serious problem with PWME. The CPET (properly performed for PWME) allows for adjustment of work depending on the capability of the patient.

I suspect that the CPET test (properly done for PWME) is not as severe as many PWME fear. I've done it (the one day test) twice now and neither time was it as terrible as I expected. Both times it was done in the office of an ME/CFS specialist by people who understand the illness. The test ran about 8 minutes. The pedaling resistance was set so easy that it was like waving my legs around, not pushing with any power at all. I didn't feel great afterwards, but I didn't have a massive crash, either.

I do not have mild ME/CFS. I'm about 5/10 on most scales. I couldn't walk more than 100 ft without PEM the last time I did the test, so it's not like I'm not susceptible to PEM or have a high threshold for PEM.

I'm not saying the test is trivial for all PWME. I think many of us have some (relatively small) consequence such as several days to a week of moderate PEM, but not a long-term crash. It's important to note that it is NOT the same test as the cardiac stress test most people imagine, which would probably seriously crash most of us, especially when done by technicians unfamiliar with the limitations of PWME.

There have been times during my illness when 8 minutes of the mildest exercise would have caused me a severe relapse, lasting for months. I was especially reactive during my first 3 years of illness. I'm more stable now, after discover pacing and implementing it strictly, but my last relapse was severe for about 6 months, and then continued moderately for months after that.
I'm not sure how I'd currently react to an 8 minute maximal CPET test, but I'd be too cautious to attempt it, unless going through a prolonged stable spell.

If anyone is brave enough to attempt such a test in the name of science, then I'd be very grateful to them, but I think we've all got to be honest with ourselves that such a test could potentially be damaging to patients. I know we are desperate for answers, but we've also got to protect each other.

Patients have got to go into such a test with eyes-wide-open, and being fully informed and fully aware of the potential for adverse effects.
Personally, I'd recommend that new patients are not put through such a test, as they wouldn't have a full insight into the nature of their post-exertional reactions, and so can't make an informed decision about it.

SOC February 3, 2014 at 7:01 pm
Ember

By insisting that Dr. Unger "assess data with an open mind, looking for unexpected patterns," are you denigrating the time-honoured practice of hypothesis testing?

Keeping an open mind while looking as what's going on and searching for patterns is the first step in science. It is called observation. It comes before the formation of a hypothesis. It's what hypotheses are based upon. First you have to develop the hypothesis, then you test it.

SOC February 3, 2014 at 7:12 pm
Bob

There have been times during my illness when 8 minutes of the mildest exercise would have caused me a severe relapse, lasting for months. I was especially reactive during my first 3 years of illness. I'm more stable now, after discover pacing and implementing it strictly, but my last relapse was severe for about 6 months, and then continued moderately for months after that.
I'm not sure how I'd currently react to an 8 minute maximal CPET test, but I'd be too cautious to attempt it, unless going through a prolonged stable spell.
If anyone is brave enough to attempt such a test in the name of science, then I'd be very grateful to them, but I think we've all got to be honest with ourselves that such a test could potentially be damaging to patients. I know we are desperate for answers, but we've also got to protect each other.

Patients have got to go into such a test with eyes-wide-open, and being fully informed and fully aware of the potential for adverse effects.
Personally, I'd recommend that new patients are not put through such a test, as they wouldn't have a full insight into the nature of their post-exertional reactions, and so can't make an informed decision about it.

I understand that many patients are afraid of the test. Exercise can be very risky for us. I'm simply suggesting that absolute rejection when you've never even seen the test done might be counterproductive.

An 8 minute maximal CPET test is not 8 minutes of maximal exercise, btw. It's only maximal (your own maximum) at the end.

I wonder if it might be informative to have a poll or some way of gathering info that would allow all members who have had the test to report the consequences they suffered. That might give us a better sense of whether it is truly dangerous for PWME and whether we should therefore discourage it's use… or conversely, whether patients are not reporting serious consequences and the test can safely be used a valuable objective measure for research studies.

Ember February 3, 2014 at 7:22 pm
SOC

Keeping an open mind while looking as what's going on and searching for patterns is the first step in science. It is called observation. It comes before the formation of a hypothesis. It's what hypotheses are based upon. First you have to develop the hypothesis, then you test it.

Can you articulate Dr. Unger's study design? Is she proceeding without research questions or hypotheses? Notice that she rejects Dr. Klimas' suggestion in the first 75 seconds here:

This quotation from “Research questions, hypotheses and objectives” may provide a useful commentary on Dr. Unger's "data-driven" approach:

The primary research question should be driven by the hypothesis rather than the data.1,2 That is, the research question and hypothesis should be developed before the start of the study. This sounds intuitive; however, if we take, for example, a database of information, it is potentially possible to perform multiple statistical comparisons of groups within the database to find a statistically significant association. This could then lead one to work backward from the data and develop the “question.” This is counterintuitive to the process because the question is asked specifically to then find the answer, thus collecting data along the way (i.e., in a prospective manner). Multiple statistical testing of associations from data previously collected could potentially lead to spuriously positive findings of association through chance alone.2 Therefore, a good hypothesis must be based on a good research question at the start of a trial and, indeed, drive data collection for the study.

A good hypothesis should precede and drive a study's data collection.

Bob February 3, 2014 at 7:25 pm
SOC

I wonder if it might be informative to have a poll or some way of gathering info that would allow all members who have had the test to report the consequences they suffered. That might give us a better sense of whether it is truly dangerous for PWME and whether we should therefore discourage it's use… or conversely, whether patients are not reporting serious consequences and the test can safely be used a valuable objective measure for research studies.

I'm not sure that would be helpful. Just because either a minority or a majority of patients have found the consequences of a CPET test to be acceptable for themselves, does not mean that it would be safe for everyone.

I'd rather have open honest discussions about it and allow individuals to decide for themselves whether or not it would be safe for them.

Some of us will decide it would be relatively safe for us to participate while others will decide it would be dangerous or potentially dangerous for us.

roonie February 3, 2014 at 9:40 pm

i think we should all do what Jim Wilson did with lyme here in Canada……raise a few dollars …..open up our own labs….hire our own docs…..get er done! There is now a treatment center in his province of British Columbia to treat lyme and other associated illnesses……even cfs/fibro.

heapsreal February 3, 2014 at 9:55 pm

If they just tested dam people who fit the ccc for nk function, rnaseL, 2 day exercise test. Im sure klimas and co have some kind of research on cytokine patterns. Check for viral reactivations and common bacterial infections.

Come on how dam hard is it? Theres 30yrs of research and we have biomarkers just have to use the dam things.

It seems like they just want to invent the dam wheel. Aarrgghh! !!!

taniaaust1 February 3, 2014 at 10:22 pm
heapsreal

If they just tested dam people who fit the ccc for nk function, rnaseL, 2 day exercise test. Im sure klimas and co have some kind of research on cytokine patterns. Check for viral reactivations and common bacterial infections.

Come on how dam hard is it? Theres 30yrs of research and we have biomarkers just have to use the dam things.

It seems like they just want to invent the dam wheel. Aarrgghh! !!!

To me avoidance of doing 2 day exercise tests is to try to play the illness down as much as the CDC can do. It shows lack of change (I believe they are only doing what they currently are doing due to public pressure, they will keep doing as little as they can do)

taniaaust1 February 4, 2014 at 2:16 pm

oh boy.. sorry all, the two above posts above over state disability service werent suppposed to be on this thread (they were meant to be on my thread). Brain fog. I'll get a mod to move them.

alex3619 February 4, 2014 at 2:40 pm
Ember

Can you articulate Dr. Unger's study design? Is she proceeding without research questions or hypotheses? Notice that she rejects Dr. Klimas' suggestion in the first 75 seconds here:

This quotation from “Research questions, hypotheses and objectives” may provide a useful commentary on Dr. Unger's "data-driven" approach:

A good hypothesis should precede and drive a study's data collection.

Chicken and egg. What data do you collect, by what methods? In order to figure that out you need some idea of what to look for: one or more hypotheses. There are millions of possible tests, nobody is going to do them all.

There is a difference between an exploratory study, in which hypothesis testing is not the goal, and a rigorous study of mechanisms, treatment etc, in which hypothesis testing should be the goal. Exploratory studies are about getting data, yet as I said you can't do that unless you have some notion of what data you want: you have to have some kind of hypothesis.

Ember February 4, 2014 at 4:46 pm
alex3619

Exploratory studies are about getting data, yet as I said you can't do that unless you have some notion of what data you want: you have to have some kind of hypothesis.

This seems to have been Dr. Unger's research question: “The question being asked over and over is, how do the patients differ in people's practices…. Is that why the findings in the laboratory are not always translatable?” To investigate the presumed heterogeneity among practices, Dr. Unger undertook “to collect standardized data on all the domains of illness included in the Canadian Consensus Criteria of CFS/ME (sic), the 1994 CFS definition and the newly proposed International ME definition.”

But Dr. Unger's interim analysis showed more heterogeneity within the patient population than among the clinics, and her questionnaires failed to identify robust subgroups:

This is just an interim analysis, and I would like to emphasize that I think that this interim analysis so far has shown us that there is a heterogeneity in the CFS population as a whole. There is a little bit between clinics but more in the patients than between clinics. This is also giving us a hint that phenotypic measures themselves may be limited in their ability to distinguish robust phenotypes or robust subgroups and that's why we're proposing to expand this study to some other measures, and it could very well be that other biologic correlates will be needed in order to better define subgroups.

Nevertheless, Dr. Unger is refusing to use credible biogenic correlates to better define subgroups.

In addressing the IOM Committee, Dr. Unger presented her study's objective this way: “To describe what the patients in these clinical practices actually look like. And so to provide data both to address how case definitions might work as well as to identify subgroups that we could find from these patients.” Dr. Unger freely expresses her opinions about how case definitions might work:

I sit here and I believe that there is no one case definition that is going to get us to homogeneity in this illness. It is way too diverse. We have to understand how to handle that diversity. I think we handle it by giving clinicians the tools to understand the full spectrum of the illness. Therapies can then be targeted to the various aspects of the disease. It’s a broad umbrella with various degrees of severity.

But beyond describing "a broad umbrella with various degrees of severity," and despite having the relevant data, Dr. Unger isn't prepared to use either Fukuda, the ICC or the CCC to better characterize her study's cohort.

Bob February 4, 2014 at 4:59 pm
Ember

But beyond describing "a broad umbrella with various degrees of severity," and despite having the relevant data, Dr. Unger isn't prepared to use either Fukuda, the ICC or the CCC to better characterize her study's cohort.

Unger is pro-actively looking for subgroups based on the data. I'd be surprised, and disappointed, if she wasn't using existing CFS & ME definitions to see if her data matches those subgroups. However it works out (i.e. if the data either matches or doesn't match the existing criteria) then that will give us helpful new information. (As long as the study is carried out competently, honestly and comprehensively, which isn't guaranteed of course.)

Beth Unger

I sit here and I believe that there is no one case definition that is going to get us to homogeneity in this illness. It is way too diverse. We have to understand how to handle that diversity. I think we handle it by giving clinicians the tools to understand the full spectrum of the illness. Therapies can then be targeted to the various aspects of the disease. It’s a broad umbrella with various degrees of severity.

That's exactly what we want her to do, isn't it?

Bob February 4, 2014 at 5:27 pm

I had forgotten the content of this video. I think perhaps it's the best review of the study that Unger has presented so far:
http://www.tvworldwide.com/events/f…_archive.cfm?gsid=2251&type=flv&test=0&live=0

@Simon reviewed it in his health-rising article:
http://www.cortjohnson.org/blog/201…c-chronic-fatigue-syndromemulti-clinic-study/

Unger starts the presentation @86.00

Some snippets:

Collected clinical data includes:
Basic Demographics.
History of illness (e.g. age of onset.)
Medical history.
Lab and other diagnostic tests.
Family history.
Infection/immunization history.

Mental health and role emotional scores are 'preserved' in CFS in all of the clinics. (i.e. CFS patients have normal outcomes for mental health scores.) (This is a novel conclusion for the CDC.)

Unger is testing the DePaul Symptom Questionnaire, along with the various diagnostic criteria.

Unger mentions that the study demonstrates that the MFI general fatigue scale is not useful for research into CFS because 40% of patients had the maximum possible score.

Ember February 4, 2014 at 5:44 pm
Bob

I'd be surprised, and disappointed, if she wasn't using existing CFS & ME definitions to see if her data matches those subgroups.

In the first 75 seconds of the IOM Committee's Q & A, Dr. Unger indicates that she isn't prepared to use existing CFS & ME definitions. She claims that she doesn't know “how to set the criteria for each of the various points of the disease criteria. In other words, there's not a cut point for any of these.”

Her description of “a broad umbrella with various degrees of severity” isn't supported by the ICC. It identifies a subgroup that needs to be removed based on much more than severity. Dr. Unger would risk identifying such an ME subgroup were she to use the 2-day CPET.

Gemini February 4, 2014 at 7:58 pm
Bob

Yes, she [Dr. Unger] must move on to including comprehensive biomedical testing, and I hope she will, quickly. If she doesn't then the trust of the patient community will not be gained…Anyway, these are just my own opinions.

Agree. Would like Dr. Unger to build on the existing science & incorporate biomarker candidates in her study.

NIH State-of-the-Knowledge Workshop (2011) identified 5 biomarker candidates [with qualifications]:
1. NK cell function [methodological issues?]
2. Perforin [by flow cytometry, a surrogate for NK cell function]
3. Dipeptidyl peptidase-4 (CD26) [an excellent cell membrane biomarker candidate]
4. Neuropeptide Y [correlates with severity of illness]
5. Cytokine panels

Byron Hyde's SPECT Scan test & the Duffy/Komaroff EEG Spectral Coherence test are additional candidates.

Perhaps a group here on PR could compile a biomarker list to suggest to Dr. Unger?

Sources:
1. "NIH ME/CFS State-of-the-Knowledge Workshop Report,""Diagnosis & Biomarkers" section, p13-4, April 7-8, 2011
http://orwh.od.nih.gov/research/me-cfs/pdfs/ORWH_SKW_Report.pdf

2. "Missed Diagnoses: Myalgic Encephalomyelitis & Chronic Fatigue Syndrome," Bryon Hyde, MD, Second Edition, 2010
http://www.lulu.com/us/en/shop/byron-hyde-md/missed-diagnoses-myalgic-encephalomyelitis-chronic-fatigue-syndrome-second-edition/paperback/product-18463888.html

3. http://www.ncbi.nlm.nih.gov/pubmed/21722376

Edited to add links to sources

Bob February 5, 2014 at 6:52 pm

This has just come through on the CFSAC email list…

MARK YOUR CALENDARS:

CDC CFS Patient-centered outreach and communication activity (PCOCA) Conference Call

Tuesday, February 25, 2014

3:00 pm * 4:00 pm EST

Call number: 1-800-369-3365
Participant Code: 1471493

Meeting Agenda

3:00pm Welcome and Telephone Overview

3:05pm Updates from CDC – Elizabeth Unger, PhD, MD

Branch Chief, Chronic Viral Diseases Branch
Centers for Disease Control and Prevention​

3:15pm "CFS and Cognitive Function"

Gudrun Lange, Ph.D.
Consultant Clinical Neuropsychologist
Pain and Fatigue Study Center
Beth Israel Medical Center, NY, NY
Professor, Department of Physical Medicine and Rehabilitation Rutgers University​

3:45pm Questions from CFSPCOCACall Mailbox for Guest Speaker and CDC

Disclaimer: Although the content of calls is directed to patients, caregivers, health care professionals, and other interested parties, CDC has no control over who participates on the conference call. Therefore please exercise discretion on sensitive content and material, as confidentiality during these calls cannot be guaranteed.

Please note that questions for the Guest Speakers and CDC can be submitted only via email at:
CFSPCOCACall@cdc.gov
This mailbox cannot respond to inquires received and is in use only for the scheduled CFS PCOCA calls.

If you would like to be added to the call list, please send an email to: CFSPCOCACall@cdc.gov

Contact for CFS PCOCA Conference Call: CFSPCOCACall@cdc.gov
The CFSAC Support Team cannot answer questions about this upcoming call.

Bob February 5, 2014 at 7:03 pm
Ember

In the first 75 seconds of the IOM Committee's Q & A, Dr. Unger indicates that she isn't prepared to use existing CFS & ME definitions. She claims that she doesn't know “how to set the criteria for each of the various points of the disease criteria. In other words, there's not a cut point for any of these.”

I wonder if Dr Unger has seen Lenny Jason's recently published research that distinguishes CFS, CFS/ME and ME patients from healthy controls by using frequency and severity of certain symptoms:
http://forums.phoenixrising.me/inde…e-learning-and-featu.27975/page-2#post-427215

Ember

Her description of “a broad umbrella with various degrees of severity” isn't supported by the ICC. It identifies a subgroup that needs to be removed based on much more than severity. Dr. Unger would risk identifying such an ME subgroup were she to use the 2-day CPET.

Agreed. But she is correct to say that the CFS cohort is a broad umbrella, etc. (And her remit is to study the entire CFS population.)

But even if looking purely at the CCC or ICC population, then there will probably be heterogeneity. We don't know if all ICC patients have the same disease. All we know is that the characteristics of their illness/es are similar. Data and research is needed to investigate it further.

I absolutely agree that the CDC needs to include proper and comprehensive biomedical research in its study, including all the tests & research that have been mentioned in this thread.
I'll be deeply frustrated if they haven't started doing this before the end of 2014. But I think it seems quite sensible for them to gather clinical and demographic data for such a large study before they move towards collecting more specific biomedical research data.

I also agree that Unger's use of language, apparent failure to engage with the community, and an apparent lack of insight into the differences between CF and ME, is deeply disappointing and frustrating.

We need the ME research community to attempt to use data to distinguish subgroups.
The CCC/ICC are a helpful guide while more research is being undertaken.
They're helpful, but they are not going to lead to answers for us in themselves.
We need more research and more data.
I'm hoping that Unger is focusing on PEM and other symptoms used in the CCC/ICC, to measure her data against in attempt to distinguish subgroups.
And I hope that she understands the difference between fatigue and ME. Otherwise it's going to be another dead-end at the CDC.

Bob February 6, 2014 at 4:14 am

Here are some extracts from the interview that address some of the issues we've been discussing in this thread…

Dr Unger

The data collected in this study will be useful in evaluating current and proposed diagnostic criteria…

Dr Unger

We do believe the study will help identify subsets of CFS patients, and equally important, will provide the tools for clinicians and researchers to use to identify similar subsets.

Dr Unger

Post-exertional malaise or post-exertional neuroimmune exhaustion is an important characteristic of CFS with no currently validated measures. We believe that the data collected in our study will help identify the best options for either measuring post-exertional malaise, or for identifying measures that correlate with this characteristic.

Gemini February 6, 2014 at 8:14 am
Bob

I absolutely agree that the CDC needs to include proper and comprehensive biomedical research in its study, including all the tests & research that have been mentioned in this thread. I'll be deeply frustrated if they haven't started doing this before the end of 2014.

Dr. Unger in her presentation Dec 2, 2013 about the CDC multi-site study is reported to have said, "Results need to be combined with biomarkers." [Ref. Dr. Ros Vallings, NCNED Centre Opening Ceremony]

A question to ask Dr. Unger on her upcoming Feb 25, 2014 conference call is: "Which biomarkers & when?"

I hope Dr. Unger was taking notes during this Ceremony when Sharni Hardcastle(Gold Coast AUS) described researchers making home visits to collect blood samples from severely ill patients. It was reported: "Follow-up with both moderately and severely ill patients showed that NK activity in the severe remained significantly far worse…She [Hardcastle] stresses the importance of looking at severity both clinically and in the laboratory."

Speaking of biomarkers, anyone know the status of Dr. Tate's work on developing a diagnostic test?

SOC February 6, 2014 at 2:46 pm
Gemini

Dr. Unger in her presentation Dec 2, 2013 about the CDC multi-site study is reported to have said, "Results need to be combined with biomarkers." [Ref. Dr. Ros Vallings, NCNED Centre Opening Ceremony]

A question to ask Dr. Unger on her upcoming Feb 25, 2014 conference call is: "Which biomarkers & when?"

I hope Dr. Unger was taking notes during this Ceremony when Sharni Hardcastle(Gold Coast AUS) described researchers making home visits to collect blood samples from severely ill patients. It was reported: "Follow-up with both moderately and severely ill patients showed that NK activity in the severe remained significantly far worse…She [Hardcastle] stresses the importance of looking at severity both clinically and in the laboratory."

Speaking of biomarkers, anyone know the status of Dr. Tate's work on developing a diagnostic test?

In other illnesses, the early research cohorts were the most severely afflicted. The thinking is that it would be easier to detect the markers of the illness in those with the worst illness. (Duh!) HIV, for example, was first detected in the most severely ill AIDS patients, not the HIV-positive people who were not yet severely ill.

I'm not sure why so many people (I include the CDC as a whole in this group) insist on doing ME/CFS research with patients at the milder end of the illness — people who are still working and those who can easily get to testing locations.

I'm 100% behind a clinical definition that (for the time being) is quite broad. We really don't know what the earliest symptoms of this illness are, and even the mild cases need treatment.

What I'm NOT behind is a research definition that includes mild patients but not severe ones. That's likely to result in ambiguous research results at best, and completely incorrect ones at worst. We are already victims of this problem.

If the CDC is focused only on getting a broad clinical perspective on the illness — one that doesn't miss anyone with the illness — then they could be headed in the right direction. Their grouping they're calling "CFS" may well include people who don't actually have the illness, but it won't leave out people who are early in the illness or have atypical presentations.

Sharni Hardcastle's report mentioned by Gemini above exemplifies the importance of using severe patients in a research cohort. We cannot allow the CDC or anyone else to blur the line between a clinical cohort which can be broad and inclusive, and a research cohort which should be tight and limited. We critically need good research and that means a clear, unambiguous sample set.

biophile February 6, 2014 at 6:38 pm
Unger

We believe that the data collected in our study will help identify the best options for either measuring post-exertional malaise, or for identifying measures that correlate with this characteristic.

The best options? Errr, what about the 2-day CPET test and the Lights' post-exercise mRNA test!!!

The word "best" should not be tossed around lightly. Her statement should have read like this:

Unger

We believe that the data collected in our study will help identify the best mediocre options for either measuring post-exertional malaise, or for identifying measures that correlate with this characteristic.

Kati February 7, 2014 at 6:40 pm
SOC

In other illnesses, the early research cohorts were the most severely afflicted. The thinking is that it would be easier to detect the markers of the illness in those with the worst illness. (Duh!) HIV, for example, was first detected in the most severely ill AIDS patients, not the HIV-positive people who were not yet severely ill.

I'm not sure why so many people (I include the CDC as a whole in this group) insist on doing ME/CFS research with patients at the milder end of the illness — people who are still working and those who can easily get to testing locations.

I'm 100% behind a clinical definition that (for the time being) is quite broad. We really don't know what the earliest symptoms of this illness are, and even the mild cases need treatment.

What I'm NOT behind is a research definition that includes mild patients but not severe ones. That's likely to result in ambiguous research results at best, and completely incorrect ones at worst. We are already victims of this problem.

If the CDC is focused only on getting a broad clinical perspective on the illness — one that doesn't miss anyone with the illness — then they could be headed in the right direction. Their grouping they're calling "CFS" may well include people who don't actually have the illness, but it won't leave out people who are early in the illness or have atypical presentations.

Sharni Hardcastle's report mentioned by Gemini above exemplifies the importance of using severe patients in a research cohort. We cannot allow the CDC or anyone else to blur the line between a clinical cohort which can be broad and inclusive, and a research cohort which should be tight and limited. We critically need good research and that means a clear, unambiguous sample set.

@SOC I agree with you to a certain degree. It makes sense.

From my point of view, the physicians that see ME patients see the ones who can make it to their offices. And often time, these patients, like me travel thousands of miles to see them. Of course the cohort will include only patients who can afford the testing since not very much is covered by insurance, for those who are insured. Moreover, the patients need to be able to complete the questionnaires. They're a lot of work.

I believe that the physicians involved in the CDC study are doing their very best with what they get- and I believe that Dr Lapp is recruiting very severe patients for a study.

I think the government will try to stall things for as long as they can. It's convenient and then patients are not very responsive due to the aspects of our illness.

That said, I am one patient who belongs in the CDC cohort- for better or for worse. I was supposed to have an exercise test either in the fall or in February and this is not materializing as of yet. Why, I don't know but suspect that patients who have made noise demanding a 2 days CPET would be a reasonable explanation.

If I am being summoned for a 1 day test it was in my intention to request to make it a 2 day test and pay the difference- as this would provide further proof of disability.

aimossy February 7, 2014 at 7:35 pm

@Gemini Hi, we are hopefully to be updated in march…I will make sure updates go on the thread when we get them.:)

Firestormm February 7, 2014 at 7:45 pm

@Kati

That said, I am one patient who belongs in the CDC cohort- for better or for worse. I was supposed to have an exercise test either in the fall or in February and this is not materializing as of yet. Why, I don't know but suspect that patients who have made noise demanding a 2 days CPET would be a reasonable explanation.

Are you suggesting that protest about not using the 2-Day test is actually delaying a major research initiative? Or perhaps I have misunderstood your meaning here. Might be worth you checking with CDC to see they haven't forgotten about you. Thanks for taking part. It must be very costly but hopefully worthwhile in the long run :)

Kati February 7, 2014 at 8:24 pm
Firestormm

@Kati

Are you suggesting that protest about not using the 2-Day test is actually delaying a major research initiative? Or perhaps I have misunderstood your meaning here. Might be worth you checking with CDC to see they haven't forgotten about you. Thanks for taking part. It must be very costly but hopefully worthwhile in the long run :)

i am not suggesting anything, I'm just saying that the exercise test was supposed to be either November or February and right now there is no clear plan. i don't know why. But I'm coming down anyways for a visit with the good doctors :-D.

Wally February 7, 2014 at 9:24 pm

A couple of reasons that the testing can be delayed would be as follows: 1) recruitment of test subjects not yet complete, 2) testing guidelines not finalized and/or 3) funding not yet received.

May be worth asking if any or the items identified above could be delaying the start of testing. I would think item no. 1 would be something each site would be tasked to do, but the CDC might be privy to where the recruitment process currently stands. Item No. 2 would be a question for CDC – who has designed the testing criteria and is this complete? Item No. 3 would again be something to ask the CDC because the funding would come out of their/HHS budget.

Bob February 7, 2014 at 9:32 pm

The delay might simply be a case of refining the methodology and finalising the logistics.

Kati February 7, 2014 at 9:53 pm

They need to make it clear, what are they testing for, what are they looking for and could they not collect bloodafter in order to confirm post exertional biomarkers. They are better getting it right because we all know what exercise costs the patients.

Ember February 8, 2014 at 2:45 pm
Gemini

Agree. Would like Dr. Unger to build on the existing science & incorporate biomarker candidates in her study…. Perhaps a group here on PR could compile a biomarker list to suggest to Dr. Unger?

Are you aware of how forcefully Dr. Under has been urged already, both during CFSAC meetings and in letters (here and here), to build on the existing science and incorporate credible biomarker candidates into her study? The empress has no clothes—as her flimsy veil of excuses shows.

Even when publicly exposed, Dr. Unger doesn't commit to redressing her failures to act. She was asked at the IOM meeting whether she has been able to do an analysis of the different case definitions yet on her data set, and she replied:

We have not done that. But it's certainly possible. The data is there. That requires a lot of interpretation that we feel will require a lot of dialogue with people. In other words, how to set the criteria for each of the various points of the disease criteria. So in other words, there's not a cut point for any of these.

Dr. Klimas followed up by pointing out that the DSQ was included among the study's questionnaires and that “Lenny Jason has an algorithm on an Excel Spreadsheet that we could use to at least look at it in that way, just to compare Fukuda with 2003 Canadian.” But Dr. Unger continued to prevaricate: “Yes, but, but, yeah, um, it's, it's still, I think, requires some interpretation and discussion. But yes, the data is there.”

Dr. Ungers' evasions suggest to me an intellectual dishonesty, the consequences of which should be considered a crime. How long does she get to play out her slow progressive reveal before being properly called to account?

Ember February 8, 2014 at 2:54 pm
SOC

I'm 100% behind a clinical definition that (for the time being) is quite broad. We really don't know what the earliest symptoms of this illness are, and even the mild cases need treatment…. We cannot allow the CDC or anyone else to blur the line between a clinical cohort which can be broad and inclusive, and a research cohort which should be tight and limited.

You're 100% behind a broad clinical definition for which illness? If ME were to be included in a broad CFS clinical definition, would exercise be prescribed or not?

The ICC allows for early diagnosis without any six-month wait period.

Disease definitions can be relaxed or tightened depending on whether they're used clinically or in research. Are you opposed to the ICC because of its being both a clinical and a research definition?

alex3619 February 8, 2014 at 4:07 pm

In any case the CDC is working toward a new research definition, if my understanding is correct. That will need to be a stronger definition than a clinical one.

Ember February 8, 2014 at 5:36 pm
alex3619

In any case the CDC is working toward a new research definition, if my understanding is correct.

Dr. Unger writes, "The data collected in this study will be useful in evaluating current and proposed diagnostic criteria, but creating new CFS case definition criteria is not a goal…. A new definition of CFS is not the objective of this study."

Bob February 10, 2014 at 12:12 am

Re the 48 hour post-exertional cognitive tests, the results may depend on the type of test used.
If my memory serves me correctly, some some studies have shown cognitive deficits in ME patients only (or mainly) in processing speed during complex tasks.
So if such a test is not included in the CDC study, then the cognitive test results might not have helpful results.

justinreilly February 23, 2014 at 11:44 pm
heapsreal

hopefully if these private guys come up with something then they might get more govt research dollars. The aussie researchers Peterson is working with at griffith uni are getting reasonable govt grants here, its not in the cancer range $$ but its more then they have done in the past. When issues start arising and being replicated then the govt are going to have to act.

Can't speak for Aussies, but the US govt is not 'going to have to act', they will just continue their charade they have been doing from day one. Look at Lyme- they (we- I have Lyme) have had the pathogen isolated for years and yet CDC and insurance backed med professors at Yale/IDSA still get away with point blank lying and screwing with the science and patients just like they do with us. Doctors even get their licenses revoked for treating with long-term antibiotics.

That doesn't mean we should lose heart, it just means don't expect that things will change overnight and CDC will fall in line if some biomarkers are replicated again. They are fighting a war against us and the science. They are just shifting their tactics slightly. Keep fighting back. Especially we need to keep going to their bosses- Congress and the President or we will get nowhere.

justinreilly February 24, 2014 at 12:00 am
JKN

I feel like a stranger in a strange land with all of this talk about the CPET test. I took a cardiac stress test 9 years ago which cause very severe disease progression and heart damage. I am now in diastolic heart failure as a result of this stress test. I also lost my ability to talk.

"Findings which suggest mitochondrial metabolic dysfunction similar to mitochondrial encephalomyopathy in CFS patients led CFS expert Professor Paul Cheney to comment. ‘The most important thing about exercise is not to have patients do aerobic exercise. I believe that even progressive aerobic exercise is counter-productive. If you have a defect in mitochondrial function and you push the mitochondria by exercise, you kill the DNA.’ Numerous heart, lung, brain and other abnormalities also show strong evidence that exercise can have extremely harmful effects on CFS patients in many different bodily systems, permanent damage may be caused, as well as disease progression." (Williams 2004, [online]).

"Not only is it inappropriate for CFS patients to undergo a treadmill stress test or be pushed toward age-predicted target heart rates, but this is potentially dangerous." Philipa Corning, Ph D, Vice President Quest 61, 2003

Dr. Paul Cheney wrote (http://www.cheneyresearch.com), "We have a rising case load of diastolic dysfunction seen in 97% of our CFS cases (avg. age 49) and some appear to have what I would call compensated diastolic heart failure. I would define compensated DHF in CFS as an extremely low cardiac output with a cardiac index (CI) below 2.0 and very poor functional capacity combined with the inability to stand which is the corollary in DHF to the inability to lay down flat in systolic heart failure (SHF). Heart failure patients are typically below 2.0 in CI. I have several CFS patients below that number and they cannot stand still for more than 15-30 seconds without having to sit down or fall down. Walking or moving helps which makes sense as that would increase filling pressures and equivalent to laying down. They might be diagnosed as having orthostatic intolerance by others."

"Recently, Jason et al (2006) reported that the mean age of patients with myalgic encephalomyelitis/chronic fatigue syndrome dying from heart failure, i.e. 58.7 years, is significantly lower than the age of those dying from heart failure in the general US population, i.e. 83.1 years."

So I am totally shocked by these exercise tests going on. Unless, I have a different disease, which I don't believe I do, or that there is a difference between ME and CFS, then I don't understand why PWCs taking this cardio test aren't having the same horrific results that I've had. If these tests expand in this study, and PWCs aren't warned of the possible results of severe permanent disease progression, then I fear what might happen to some patients.

Furthermore, I don't understand why there are no research studies going on today reg. the effects that ME/CFS has on the heart, i.e. this is one of the main causes of death from ME/CFS.

When I look at the current research most of it seem irrelevent to me. None of it is going to save my life.

So I just wanted to put out this warning for PWCs taking these cardio stress tests, because there seems to be no serious warning out there. I don't think most ME/CFS doctors understand the possible consequences.

I think these are very good points!

Bob February 24, 2014 at 3:33 am

Does anyone have any information on the genomic study that the CDC is supposed to be doing?
Either I've not seen any details about it, or I've forgotten.

Bob February 25, 2014 at 8:21 am

Reminder that this conference call takes place today.

There's a separate thread about it here:
http://forums.phoenixrising.me/index.php?threads/february-25th-pcoca-call-with-cdc.27803/

MARK YOUR CALENDARS:

CDC CFS Patient-centered outreach and communication activity (PCOCA) Conference Call

Tuesday, February 25, 2014

3:00 pm * 4:00 pm EST

Call number: 1-800-369-3365
Participant Code: 1471493

Meeting Agenda

3:00pm Welcome and Telephone Overview

3:05pm Updates from CDC – Elizabeth Unger, PhD, MD

Branch Chief, Chronic Viral Diseases Branch
Centers for Disease Control and Prevention​

3:15pm "CFS and Cognitive Function"

Gudrun Lange, Ph.D.
Consultant Clinical Neuropsychologist
Pain and Fatigue Study Center
Beth Israel Medical Center, NY, NY
Professor, Department of Physical Medicine and Rehabilitation Rutgers University​

3:45pm Questions from CFSPCOCACall Mailbox for Guest Speaker and CDC

Disclaimer: Although the content of calls is directed to patients, caregivers, health care professionals, and other interested parties, CDC has no control over who participates on the conference call. Therefore please exercise discretion on sensitive content and material, as confidentiality during these calls cannot be guaranteed.

Please note that questions for the Guest Speakers and CDC can be submitted only via email at:
CFSPCOCACall@cdc.gov
This mailbox cannot respond to inquires received and is in use only for the scheduled CFS PCOCA calls.

If you would like to be added to the call list, please send an email to: CFSPCOCACall@cdc.gov

Contact for CFS PCOCA Conference Call: CFSPCOCACall@cdc.gov
The CFSAC Support Team cannot answer questions about this upcoming call.

Ritto February 25, 2014 at 8:40 am

I was recently able to listen to a conference call, from the UK, on Skype, from which there was no charge.

Bob February 25, 2014 at 2:20 pm

I just listened to the CDC's 25th Feb telephone conference call.

Beth Unger said that the exercise study will begin soon.

They are awaiting approval from a research ethics committee, and expect to get approval soon.

On a separate note, stage 3 of the CDC's project will include both homebound and newly diagnosed patients.

Bob February 25, 2014 at 2:28 pm

Beth Unger has said that the cognitive tests for the CDC multi-site study have been planned in consultation with Dr Gudrun Lange*.

Dr Gudrun Lange gave a talk on the CDC's 25th Feb telephone conference call.

I was very impressed by her talk, and so I hope her knowledge is reflected in the cognitive tests that the CDC use.

Lange mentioned that, in cognitive tests, ME/CFS patients are accurate but slower.
And she said that complex tasks show most difference from controls:
ME/CFS patients have difficulty with complex information processing and multi-tasking.

In a swipe at those who dismiss ME/CFS patients' cognitive problems, Lange said that ME/CFS patients do not amplify their cognitive problems (i.e. they do not invent them), but they have cognitive problems that may not be picked up by simple tests that do not test complex cognitive functioning.

This is exactly how I understand the nature of ME patients' cognitive function, from research studies that I've read.
i.e. for simple tasks our tests results can be normal, but differences show up on complex processing tasks, specifically processing speed during complex tasks.

* Gudrun Lange, Ph.D.
– Consultant Clinical Neuropsychologist, Pain and Fatigue Study Center, Beth Israel Medical Center, NY, NY.
– Professor, Department of Physical Medicine and Rehabilitation Rutgers University.

Firestormm February 25, 2014 at 3:03 pm

@Simon See above – you mentioned cognition earlier on the dog-and-bone.

Mark February 25, 2014 at 6:17 pm
Bob

Beth Unger has said that the cognitive tests for the CDC multi-site study have been planned in consultation with Dr Gudrun Lange*.

Gudrun Lange gave a talk on the CDC's 25th Feb telephone conference call.

I was very impressed by her talk, and so I hope her knowledge is reflected in the cognitive tests that the CDC use.

Lange mentioned that, in cognitive tests, ME/CFS patients are accurate but slower.
And she said that complex tasks show most difference from controls:
ME/CFS patients have difficulty with complex information processing and multi-tasking.
In an attack on those who dismiss ME/CFS patients' cognitive problems, Lange said that ME/CFS patients do not amplify their cognitive problems (i.e. they do not invent them), but they have cognitive problems that may not be picked up by simple tests that do not test complex cognitive functioning.

This is exactly how I understand the nature of ME patients' cognitive function, from research studies that I've read.
i.e. for simple tasks our tests results can be normal, but differences show up on complex processing tasks, specifically processing speed during complex tasks.

* Gudrun Lange, Ph.D.
Consultant Clinical Neuropsychologist, Pain and Fatigue Study Center, Beth Israel Medical Center, NY, NY.
Professor, Department of Physical Medicine and Rehabilitation Rutgers University.

Simon wrote a great article about the evidence on cognitive function in ME/CFS last year:
http://phoenixrising.me/archives/16688

Simon February 27, 2014 at 3:40 am
Bob

Beth Unger has said that the cognitive tests for the CDC multi-site study have been planned in consultation with Dr Gudrun Lange*.

Dr Gudrun Lange gave a talk on the CDC's 25th Feb telephone conference call.

I was very impressed by her talk, and so I hope her knowledge is reflected in the cognitive tests that the CDC use.

Lange mentioned that, in cognitive tests, ME/CFS patients are accurate but slower.
And she said that complex tasks show most difference from controls:
ME/CFS patients have difficulty with complex information processing and multi-tasking.

In a swipe at those who dismiss ME/CFS patients' cognitive problems, Lange said that ME/CFS patients do not amplify their cognitive problems (i.e. they do not invent them), but they have cognitive problems that may not be picked up by simple tests that do not test complex cognitive functioning.

This is exactly how I understand the nature of ME patients' cognitive function, from research studies that I've read.
i.e. for simple tasks our tests results can be normal, but differences show up on complex processing tasks, specifically processing speed during complex tasks.

* Gudrun Lange, Ph.D.
Consultant Clinical Neuropsychologist, Pain and Fatigue Study Center, Beth Israel Medical Center, NY, NY.
Professor, Department of Physical Medicine and Rehabilitation Rutgers University.

Dont suppose anyone has a recording of this call? I was late, and it wouldn't let me in!

Bob February 27, 2014 at 3:56 am
Simon

Dont suppose anyone has a recording of this call? I was late, and it wouldn't let me in!

Yes, there's a recording here:
http://forums.phoenixrising.me/inde…-pcoca-call-with-cdc.27803/page-2#post-434408

shahida March 28, 2014 at 1:13 pm

hi I've some questions:
*will Dr Lipkin do actual stomach muscle biopsies for this study?
*which criteria does it use to determine 'me/cfs' patients?
*it looks increasingly like the me community will have to self fund such studies but is there a more effective way of finding out about them as opposed to ill people having to go onto this site? There's nothing wrong with that in principle but many people just can't and no one I know with ME knows about this as they're too ill too actually expend scant energy as look stuff up. eg. is there a emailing system where the latest research appeals come to you? Maybe emails to all the a few people in the local support groups across the world who may be able to tell others in the group eg. via newsletters and email. It could be given a name like 'local support group information (or something better what with brain fog) . I've only found out about this by looking this up and I can't (or shouldn't) do that so often .. This way we'd maximise the money raised.
thanks for any info' out there

Bob March 28, 2014 at 1:26 pm
shahida

hi I've some questions:
*will Dr Lipkin do actual stomach muscle biopsies for this study?
*which criteria does it use to determine 'me/cfs' patients?
*it looks increasingly like the me community will have to self fund such studies but is there a more effective way of finding out about them as opposed to ill people having to go onto this site? There's nothing wrong with that in principle but many people just can't and no one I know with ME knows about this as they're too ill too actually expend scant energy as look stuff up. eg. is there a emailing system where the latest research appeals come to you? Maybe emails to all the a few people in the local support groups across the world who may be able to tell others in the group eg. via newsletters and email. It could be given a name like 'local support group information (or something better what with brain fog) . I've only found out about this by looking this up and I can't (or shouldn't) do that so often .. This way we'd maximise the money raised.
thanks for any info' out there

Hi shahida, and a very big welcome to the forum. :)

You've posted your message on a thread about the CDC's program, but you seem to be asking about Dr Lipkin's research.

If you're responding to a recent article about Dr Lipkin's proposed microbiome study, it would be best to post a comment on that thread.

If you'd like me to copy your questions over to the appropriate thread, then please let me know.

This is the recent article about Dr Ian Lipkin and the fundraising project:
http://forums.phoenixrising.me/inde…robiome-crowdfunding-campaign-launches.29252/

shahida April 5, 2014 at 12:02 pm
Bob

Hi shahida, and a very big welcome to the forum. :)

You've posted your message on a thread about the CDC's program, but you seem to be asking about Dr Lipkin's research.

If you're responding to a recent article about Dr Lipkin's proposed microbiome study, it would be best to post a comment on that thread.

If you'd like me to copy your questions over to the appropriate thread, then please let me know.

This is the recent article about Dr Ian Lipkin and the fundraising project:
http://forums.phoenixrising.me/inde…robiome-crowdfunding-campaign-launches.29252/

yes thanks Bob it would be great if you could do that. My brain really can't handle computers well-sites are so 'busy'. my apologies but I'm sure you understand….

Bob November 8, 2014 at 4:50 pm

Simmaron Research has published a new blog on its website by Cort Johnson about the CDC's multi-site study. I don't think there's any new information in it.

Going Grassroots: Dr. Unger on the CDC’s Chronic Fatigue Syndrome Multisite Studies
Cort Johnson
November 8, 2014

http://simmaronresearch.com/2014/11…s-chronic-fatigue-syndrome-multisite-studies/

(If anyone wants to start a new thread about it then please do.)

Hate ME/CFS November 9, 2014 at 4:44 pm

Dr Beth Unger refuses to remove the CDC's outdated "toolkit", and she has refused to recognize the CCC definition of CFIDS. Maybe if they did one of these two things, the CDC could be taken seriously.

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