CDC Study Must Include CPET, NK Cell and Viral Testing, Advocates Insist

August 2, 2013

Mark Berry invites readers to join 11 organizations and 31 advocates and write to the CDC, asking them to include appropriate medical tests in their multi-site study.

The historical approach of the US Centers for Disease Control and Prevention (CDC) to the study of ME/CFS has not been universally well-received – and that’s an understatement. The majority opinion of the ME/CFS community seems to be that the CDC has had its head stuck in the sand, as far as ME/CFS is concerned, ever since CDC epidemiologists finally rolled into Lake Tahoe to investigate the outbreak there in 1984. But in recent years there have been some promising signs that the CDC may at last be starting to take the disease more seriously.

The CDC’s multi-site, multi-phase clinical assessment study aims to “describe the differences and similarities among CFS patients,” “improve how we measure illness domains of CFS,” “address the CFS case definition,” and possibly allow patients “to be sub-grouped to improve therapy and allow the underlying biology to be discovered.”

Such a large study, led by a federal agency, represents a major opportunity for patients, both in the United States and around the world. There is at least a chance that it might bring some much-needed clarity to the questions and problems surrounding case definitions and subsets which have dogged ME/CFS research for decades.

So it’s a very important study for ME/CFS patients, and it’s important too for the credibility of the CDC, so badly damaged in the eyes of the patient community by the scandal over the diversion of funds allocated for ME/CFS research – not to mention more than 25 years of failure to make meaningful progress in the study of an illness that blights the lives of millions of patients. The CDC study is already collecting a mountain of data – but in research, what answers you can find depends on the questions you ask, and the data you collect…and there, it appears, we may have a problem…

Missing Information

Although the study has already collected a vast array of data on clinical history and demographics, and patients have filled in a long list of questionnaires, so far there’s been a worrying lack of tests that could help confirm biological abnormalities in ME/CFS patients. More worrying still, at the last CFSAC meeting in May 2013, Dr Unger appeared to indicate resistance to the idea of conducting the very tests that many consider crucial to understanding the nature of the pathology in ME/CFS.

Repeat exercise testing is considered by many to be the fundamental test necessary to confirm post-exertional malaise – widely seen as the cardinal symptom of ME/CFS – but is the CDC prepared to conduct the tests necessary to demonstrate it, or will it deploy other tests that are known to miss this crucial phenomenon? Simon McGrath reported on Dr Chris Snell’s recent study of CPET abnormalities earlier this week – both Keller and Vemeulen have also confirmed what many practitioners and patients know from long experience: repeat testing is necessary to demonstrate the distinctive effects of exercise on ME/CFS patients. This finding may be in tune with patients’ subjective experiences, but it does need further confirmation in larger studies. What better opportunity than the CDC’s large-scale study to explore this crucial question?

A wealth of research has also highlighted the significance of viral infections and immune dysfunction in ME/CFS, but will the CDC even measure NK Cell Function and test for viruses associated with ME/CFS?

It is far from clear that the CDC intends to ask any of these questions: the detail so far on the promised blood testing seems vague at best. And with the CDC having already admitted that their study has not yet found a way to study any of the most severely affected housebound and bedbound patients, there’s a considerable risk that the CDC’s study may fail to study ME at all – a frightening prospect if its conclusions are going to be interpreted and applied as if they had done so.

What hope is there for a useful outcome from this study if the CDC fails to assess the most promising candidates for biomarkers discovered in the last 20 years of ME/CFS research? What chance that the research will help to restore common understanding to a fractured field if it excludes the most promising tests indicated by the work of ME/CFS researchers? Do the study’s findings, and any recommendations for case criteria which may result from it, have a realistic chance of being respected and accepted, rather than opposed by the patient and advocacy community, if the study fails to ask the very questions that many patients, advocates and researchers consider to be the most crucial?

The danger that this study may become yet another missed opportunity – or worse, bury the reality of a serious illness even deeper below a mountain of obfuscation – seems very real to many advocates, who are disturbed by the apparent intention of the CDC to exclude crucial evidence from the study.

Letter to the CDC

Change Request FormWith these concerns in mind, on July 22nd, 11 patient organizations (including Phoenix Rising) and 31 patient advocates wrote to Dr Unger, Secretary Sebelius, Dr Koh, Dr Frieden, the sites participating in the CDC study and their clinicians, and the members of CFSAC, urging them not to rely on self-reported measures but to include objective measurements in their study. Specifically, the letter calls for the inclusion of 2-day Cardiopulmonary Exercise Testing or CPET (using the Stevens Protocol) and laboratory tests to measure Natural Killer Cell function and viral load, including enteroviruses.

The letter includes an extract from the CFS Advisory Committee meeting of May 2013, reminding Dr Unger of the testimony of Fred Friedberg that post-exertional malaise is “uniquely important” in the essence of this illness, and of Steve Krafchick who said that he would “get down on his knees and plead” with Dr Unger for the integration of neuro-psych testing and CPET into the study because it represents “the most objective evidence that you could ever hope to get”, adding: “patient report is nice, and it’s cheap, but if we’re trying to do what you said you were trying to do – don’t miss this opportunity please.”

Also included with the letter are academic references in support of the call for the use of CPET, and the list of organizations and advocates who signed it. You can read the letter and supporting information here, and the letter sent to clinicians is available here.

The letter’s conclusion sums up its message: “Objective, biological measurements are vital in order to describe the differences and similarities among patients, determine how we characterize and treat patients, address the case definition issues, educate our medical community, and further our understanding of the underlying biology of ‘CFS’.  For that reason, we urge you to consider incorporating these important tests as soon as possible”.

“Please know that we are willing to do everything within our power to work with you and the clinicians involved in order to accomplish this crucial goal. Like you and your colleagues, we want this study to be a success.”

So: A wide range of organizations and patient advocates have spoken. Over now to Dr Unger and the CDC: are they prepared to test ME/CFS patients for biological abnormalities, or are their heads still stuck firmly in the sand?

How to Add Your Voice

11 organizations and 31 patient advocates have spoken – now we urge the wider ME/CFS community, including non-US residents, to add their voice and add to the pressure on the CDC to include these objective measurements in their study.

Erica Verillo has produced the following template letter – a shorter version of the letter already sent to Dr Unger – which you can use to add your voice in support of this campaign. Please feel free to edit it and add your own comments…and to indicate your support for the letter on the discussion thread below this article…

 

Elizabeth Unger, PhD, MD, Chief of the Chronic Viral Diseases Branch

Centers for Disease Control and Prevention (CDC)

1600 Clifton Road

Atlanta, GA 30333

 

Dear Dr. Unger,

In 2012, the CDC initiated a multi-site, multi-phase clinical assessment study to describe the differences and similarities among ME/CFS patients, determine how we characterize and treat patients, implement an accurate case definition, educate our medical community, and further our understanding of the underlying biology of ME/CFS.

Because the CDC’s multi-site study represents a major opportunity to make a difference for patients – both in the United States and around the world – objective, biological measurements are vital. However, a clinical investigation that does not include proper methodology to obtain objective data will fail to achieve its goals and will result in lost time, lost investment, and worst of all, lost opportunity.

It is absolutely essential that the CDC study include two objective tests which have consistently revealed abnormalities in ME/CFS patients. These tests are:

1)     The two-day Cardiopulmonary Exercise Test (CPET). The two-day CPET provides gas exchange and other objective and measurable results “which can’t be faked.” Numerous studies have shown that the 2-day CPET – as opposed to the 1-day CPET – is a reliable and consistent method for measuring post-exertional malaise (PEM), the hallmark symptom of ME/CFS. This test can be done employing technology which has been used in hospitals for decades.

2)     Low Natural Killer Cell Function/Viral Load. Abnormally low NK Cell activity and high viral loads are consistent findings in patients with ME/CFS. These tests can be done in many labs around the country and will provide objective, measurable data for comparison purposes.

Measuring and understanding post-exertional malaise (PEM) is crucial to this study. PEM is not only the primary symptom that distinguishes ME/CFS from depression, deconditioning, and other fatiguing illnesses, it is the ME/CFS sufferer’s main obstacle to daily activities, gainful employment, and leading a normal life.

Please include the 2-day CPET and tests for NK-Cell function and viral load in the CDC’s multi-site study.

Thank you,

(Your name, City and State, or Country)

 

How You Can Support Phoenix Rising

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

There are many ways you can help Phoenix Rising to continue its work. If you feel able to offer your time and talent, we could really use some more authors, proof-readers, fundraisers, technicians etc. and we’d love to expand our Board of Directors. So, if you think you can help then please contact Mark through the Forum.

And don’t forget: you can always support our efforts at no cost to yourself as you shop online! To find out more, visit Phoenix Rising’s Donate page by clicking the button below.

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44 comments

{ 44 comments… read them below or add one }

Sasha August 2, 2013 at 7:43 am

Mark – I tried both links in this para and they didn't work for me – I got a Googledocs page each time but without a document:

"Also included with the letter are academic references in support of the call for the use of CPET, and the list of organizations and advocates who signed it. You can read the letter and supporting information here, and the letter sent to clinicians is available here."

Firestormm August 2, 2013 at 7:52 am


Sasha

Mark – I tried both links in this para and they didn't work for me – I got a Googledocs page each time but without a document:

"Also included with the letter are academic references in support of the call for the use of CPET, and the list of organizations and advocates who signed it. You can read the letter and supporting information here, and the letter sent to clinicians is available here."

Hi Sasha,

Are you logged in to google? Only the links work fine for me. Not sure if logging in is a factor – you know by now how I am with technology – but it might be :)

Sasha August 2, 2013 at 7:56 am


Firestormm

Hi Sasha,

Are you logged in to google? Only the links work fine for me. Not sure if logging in is a factor – you know by now how I am with technology – but it might be :)

Oh! I am now and can see it. Pity people need a google account to see this.

Bob August 2, 2013 at 7:59 am

You don't need to log into google. They are publicly viewable documents.

These are the two links from that paragraph, in case helpful:
https://docs.google.com/file/d/0B6Djlzj1SPi5S0lSLXJta3BNeWs/edit?pli=1
https://docs.google.com/file/d/0B6Djlzj1SPi5US1xX2dIWmRfV00/edit?pli=1

Sasha August 2, 2013 at 8:08 am


Bob

You don't need to log into google. They are publicly viewable documents.

These are the two links from that paragraph, in case helpful:
https://docs.google.com/file/d/0B6Djlzj1SPi5S0lSLXJta3BNeWs/edit?pli=1
https://docs.google.com/file/d/0B6Djlzj1SPi5US1xX2dIWmRfV00/edit?pli=1

Can you see the docs when you're logged out, Bob? I couldn't – it told me I had to sign in.

Anyway, technicalities apart, it's interesting that the letter to clinicians is to those clinicians who've signed up to be part of the study – a great piece of advocacy, I thought, going straight to the clinicians on the ground and bypassing Dr Unger. Those clinicians need to be aware of the issues themselves.

Roy S August 2, 2013 at 8:09 am

Thanks, Mark, and to everybody involved in this.

I often use my dry sense of humor (which is not always apparent to everybody) to try to cheer up folks on the internet groups, but on this subject we need to be SERIOUS. There is a long history of prejudice at the CDC towards the ME/CFS community and especially patients. It's not just stigma and bias. While there are some slight indications of movement in the right directions I don't think we can trust them EVER. The problems go into the higher levels of management and always have.

There was an anonymous patient's input about the CDC program on this thread earlier this year.

http://forums.phoenixrising.me/inde…n-questionnaires-in-me-cfs.21578/#post-329318

Firestormm August 2, 2013 at 8:37 am


Roy S

There was an anonymous patient's input about the CDC program on this thread earlier this year.

http://forums.phoenixrising.me/inde…n-questionnaires-in-me-cfs.21578/#post-329318

Thanks Roy I must have missed that from January. Does this comment from anonymous mean that these things were being tested for:

I have two questions for Dr Unger:
I am an M.E. participant in your multi-center CDC "CFS" study. I meet all the criteria for CCC and ICC M.E. While I was delighted to receive V02 Max testing, immune/virological panels and post-exercise gene expression, I was dismayed at the volume of leading questions in the CDC surveys used, which I believe are biased to an inappropriate diagnosis of depression.

If so in what way? Thanks. Little confused with what went before and what is now being looked at. I realise it is multi-stage, but some clarification of the objective testing done before would be appreciated. Thank you.

Roy S August 2, 2013 at 9:20 am

Hopefully someone will answer your question better than I can at present due to heavy brain fog.

Sasha August 2, 2013 at 10:31 am

Anyway! Thanks for this article, Mark.

The outcome of this major CDC study will impact PWME all over the world when it comes out so those of us outside the US as well as within it should be joining in with this.

Mark August 2, 2013 at 10:56 am


Sasha

Can you see the docs when you're logged out, Bob? I couldn't – it told me I had to sign in.

Strange, I just signed out of google and tried those links, and it took me straight to the documents without asking me to sign in. Maybe try clearing your browser's cache first? I think this has happened before with shared google docs; most people seem to be able to see them publicly OK, but a few get asked to sign in. They're shared to 'everyone with the link' so I'm not sure what else to do.

Mark August 2, 2013 at 11:24 am


Firestormm

Thanks Roy I must have missed that from January. Does this comment from anonymous mean that these things were being tested for…If so in what way? Thanks. Little confused with what went before and what is now being looked at. I realise it is multi-stage, but some clarification of the objective testing done before would be appreciated. Thank you.

Thanks Roy and Firestormm for digging that up. I tried to find detail on what exactly is being tested but didn't get very far with that. Note that, in the letter, the reference to viral testing and NK cells says 'if not already included in the study protocol', so it seems like nobody else has been able to find out the detail of those tests yet either. I think that's the point really: the devil is in the detail on these things. What exactly you test for, and how, will determine what you will find. And what decisions you make about that will probably depend on your prejudices to some extent, so there's a lot of room for experimental bias in those decisions.

The principle that study protocols should be announced in advance and openly reviewed is gaining a lot of traction these days – I do think that's a far better way to conduct scientific investigations, especially for publicly-funded studies of controversial subjects with significant public interest in the results. It's therefore very important to clarify the detail of these tests, and if the tests being used aren't going to look for the things we want them to look for, we can then press for other tests to be included. At the end of the day, if the tests that the community wants aren't included, it seems likely that the meaning of the study's results will be bitterly disputed and perhaps rejected by the community, which will continue to have consequences down the line, so if the CDC wants to resolve these issues, it's in their interest to include the tests we ask for. I shudder to think how ME/CFS advocacy might evolve in the future if the CDC doesn't get it right this time.

The exercise testing is particularly troubling: the evidence seems to suggest that plain VO2 max testing as opposed to repeat testing won't show up the PEM – I think there's a quite clear and compelling logic to that – and if they only test using a protocol that doesn't find the abnormalities, that could have very negative consequences. The same kind of problem may apply to the viral and immune testing, I just don't know. That's why I'm hoping that we will get some clarification on those details now – we've asked for a reply by Aug 31st so perhaps the detail of these issues will all become clearer by then.

Sasha August 2, 2013 at 11:36 am

I think this is a very good action. It's one thing to criticise the outcome of a study after the fact but if you can say, 'we pointed out these shortcomings before the study began and the authors chose to ignore them' then that's a whole different ballgame. We need to be on top of these things as they're starting, if we can, before we can be accused of bias because we don't like the results.

I agree that publicly-funded studies should disclose. They should also be disclosing to their participants.

jimells August 2, 2013 at 12:08 pm

My brain must not be working today… I'm certain someone on this thread wrote that the diagnostic tests in this study remain unknown. How can this be? Don't study participants have to be told what is being done to them as part of 'informed consent'?

Are research study details now part of National Fatherland Security?

Nielk August 2, 2013 at 1:23 pm

Thank you Mark and for all those who were involved in this work.

How appropriate that this follows Simon's article about Dr. Snell's new study on repeated CPET testing.

If the CDC really wants to show that they consider ME a serious disease, as they have stated, this is their opportunity to prove it!

It seems that the CDC wants to put their past history with ME/CFS behind them and have openly admitted that they consider ME/CFS a serious disease. I challenge them that they should put their money where their mouths are. If they are putting money and effort into a multi-site study, do it right – the first time around. This is a great opportunity to show us that:

1- You are listening to us
2- You really believe that this is a serious biological disease
3- You take into consideration the peer-reviewed studies out there that show the hard facts of these objective findings.
4- You are using the funds allocated to us (ME/CFS patients) in the most effective manner
5- There is transparency in what you do

I really hope that this letter will be looked at seriously and taken into account. In either case, it will become apparent soon to all of us watching whether the CDC is serious about this serious illness.

Ember August 2, 2013 at 2:19 pm

Dr. Unger should be reminded too of the ME Primer's Laboratory/Investigative Protocol. It includes the test for PENE, a 2-day CPET (using the Stevens Protocol), as well as laboratory tests to measure NK cell function and viral load, including enterovirises:

Laboratory/Investigative Protocol: Diagnose by criteria. Confirm by laboratory and other investigations. A broad panel of tests provides a more robust basis to identify symptom patterns, abnormalities and orient treatment.
Routine laboratory investigation: CBC, ESR, CA, P, RBC Mg, vitamin D3, B12 & folate, ferritin, zinc,FBS,PC, Hb A1C,
serum electrolytes, TSH, protein electrophoresis screen, CRP,creatinine, ECG (U+ T wave notching), CPK and liver function,
□ rheumatoid factor, antinuclear antibodies, urinalysis, essential fatty acids,CoEnzyme Q10, immunoglobulins, diurnal cortisol levels, TTG, serotonin
Additional laboratory investigation: (as indicated by symptoms, history, clinical evaluation, lab findings, risk factors) 24 hour urine free cortisol,
DHEA sulphate, ACTH, chest x-ray, hormones including free testosterone, panoramic x-ray of dental roots, amino acid profile,
abdominal ultra sound,lactose/fructose breath test
Further testing with specificity to ME, if and as indicated. Some tests are in the research stage but can identify abnormalities and focus treatment. Viral tests should be interpreted by a physician experienced in these infections.
Pathogen: Enterovirus; Tests: RT-PCR, serology, stomach biopsy
Pathogen: mycoplasma; Tests: DNA-PCR, serology
Pathogen: EBV, CMV, HHV-6; Tests: DNA-PCR, serology, antigenemia
Pathogen: Borrelia burgdorferi; Tests: DNA-PCR,serology, Western Blot
Pathogen: Clamydia pneumonia; Tests: DNA PCR, serology
Pathogen: Parvovirus B19; Tests: DNA-PCR,IgG, IgM,
Immune system profiles: *NK cell function & cytotoxicity; B & T-cell function: IgG,IgG subclasses 1-4;IgA, IgM (shift from T1 to T2), cytokine/chemokine profile panel (94% accuracy): IL-8, IL-13, MIP-1β, MCP-1, IL4,flow cytometry for lymphocyte activity, □ ↑37 kDa 2-5A RNase L immunoassay – defect/ratio & bioactivity, food sensitivity panel, chemical sensitivities, stool for WCB – D-lactic acid bacteria balance, ova & parasites, autoimmune profile, Intestinal dysbiosis:IgA & IgM for intestinal aerobic bacteria in serum, □ ↑ leukocyte elastase activity in PBMCs, IgG food intolerance test,toxoplasmosis
Neurological & static testing: *SPECT scan with contrast – ↓ cortical/cerebellar region cerebral blood flow (rCBF) in the frontal, parietal, temporal and occipital & brain stem regions – more brain involvement indicates increased illness severity,MRI of brain(increased T2-weighted images in high white matter tracts & loss of GM volume) & rule out MS, MRI of spine (dynamic disc bulges/herniation , stenosis), sleep study (stage 4 sleep, sleep pattern & rule out treatable sleep dysfunctions – upper airway resistance syndrome, sleep apnea, etc.)
PENE: A 2 consecutive day comprehensive 8-12 minute cardiopulmonary exercise stress test (measuring heart, lung, and metabolic function) – only ME patients have significantly worse scores the second day & abnormal recovery from exertion. * Exercise tolerance test with expired gas exchange - (2 consecutive days) – measure cardiovascular, pulmonary & metabolic responses at rest & during exercise: peak oxygen consumption VO2 or VO2 at anaerobic threshold (AT) – decline of 8% or greater on test 2 indicates metabolic dysfunction, post-exercise blood analysis – increase in sensory, adrenergic and immune genes – increase in metabolite receptors unique to ME
Energy metabolism/ion transport: ATP profile identifies insufficient energy due to cellular respiration dysfunction
further ATP related parameters, superoxide dismutase and cell-free DNA Respiratory:pulmonary function test Cardiovascular: Tilt table test to confirm OI (70 -80% tilt, measure HR continuously, BP periodically – 30 min or presyncope); Cardiac output decreases - left ventricular dysfunction in the heart; 24-Hour Monitor for suspected arrhythmia, NMH/POTS, myocarditis (Note: Repetitively oscillating T-wave inversions &/or T-wave flats, typical of ME, may be subsumed under non-specific T-wave changes.)

These tests, used to confirm a diagnosis of ME, would allow ME patients to be removed from the more encompassing CFS classification. "The need is not only for a case definition," according to Dr. Unger's June 5 letter to patient organizations and independent patient advocates, “but also for reproducible standardized approaches to applying it, as well as for biomarkers to refine subgroups within the overall CFS population.”

SpecialK82 August 2, 2013 at 2:49 pm

Thanks Mark and all the patient organizations and advocates. I'm thrilled that you guys are on top of this issue and are taking action.

I am concerned that a letter to Dr. Unger probably won't accomplish anything unfortunately. The CPET omission was pointed out to her at the last CFSAC and she didn't seemed moved by the arguments. How many times has she received letters and heated testimony about taking down the CDC toolkit – and she has not even considered taking it down while the new one is being written. All the while, respected doctors and researchers on CFSAC were making the recommendations as well.

The letter to clinicians is a brilliant idea! These folks will probably be the ones that could put the most pressure on her. I would strongly suspect that these good ME/CFS docs would have called this study flaw out to the CDC even in absence of this letter to them (or one would hope).

May I suggest that the patients write each one of the study centers and encourage them to do this correctly? Especially anyone that is a patient at one of these sites. The good doctors should absolutely put their foot down with this nonsense and I can't imagine it would take much arm twisting for them to agree.

Do we have a link to a list of study sites??

So back to the CDC, I believe the real question is:
How do we actually break through to them and optimize our chance for meaningful change? What's our options:

Going above Dr. Unger's head:
If memory serves, I believe just at the last CFSAC (or possibly FDA meeting?), a letter(s) had been written to her superior and I believe she said something to the effect of "he just handed the letter to me to handle". I remember cringing at that very moment. It still might be a valuable route down the line however, but it's very tricky to navigate.

How about going to Sec. Sebellious directly? IMO, she has never done much for us (CFSAC) so it's difficult to imagine she will now.

President Obama? As I understand Bob Miller has lost the White House connection once his contact left the position.

So overall, going above her head may be a strategy for down the road (hopefully there is a better path than I realize).

Getting a meeting with Dr. Unger:
One of the more frustrating problems in dealing with some of these agencies, is not that they deny our requests, but that they don't explain their reasoning for it. How can we present evidence to rebut their argument when we don't know what it is? If Dr. Unger were willing to meet with a small group of advocates and have a meaningful conversation, it's possible we can influence some of the testing. Maybe some docs need to be in on the meeting. I think the most important point would be to get people that she respects at the table, specifically researchers that understand how to set up study designs.

In my opinion, getting these key people (docs, researchers, etc.) to buy into a meeting with her would be vital. Then they could send her a request for it. That would be the path that I think would be most fruitful.

Now, the advocates that sent the letter may already have a stage 2 and stage 3 planned if she does not respond or if she poorly responses. That would be terrific to hear (If so, I realize that they may not want to tip their hand at this point). There are people like Steve K from the CFSAC that may be able to advise us as well (unless it's a conflict of interest for him.)

We really need someone that understands the bureaucracy in Washington I think. I wonder if Wanda Jones might tell us how to complain in a highly-effective, response driven way??

heapsreal August 2, 2013 at 2:51 pm

I think using the biomarkers eg nk function particularly bright nk cell function along with other viral markers as well as cd8 t cell dysfunction would be a good start.and are only going to help further research on our illness and make it more respected. hopefully this type of testing will be made available world wide to help diagnose ME.

dmbaken August 2, 2013 at 6:05 pm

Anybody got her email address handy?

lastgasp August 3, 2013 at 12:43 am

"Abnormally low NK Cell activity and high viral loads are consistent findings in patients with ME/CFS. "

They're also found in patients with clinical depression, apparently, so it might be better to concentrate on something else. Reduced T-cell responsiveness &/or T-reg abnormality, muscle fibre abnormalities, glial activation, spinal fluid pressure and proteins, autoantibodies, active HHV6 or RNA enterovirus etc? It has to have specificity as well as sensitivity otherwise it allows the CDC to get away with their usual old rope.

They should use a handgrip strength test as well which would allow to include severely affected patients in the CPET.

Sasha August 3, 2013 at 1:38 am


SpecialK82

So back to the CDC, I believe the real question is:
How do we actually break through to them and optimize our chance for meaningful change? What's our options:

Another post where the 'Like' button doesn't seem adequate – great stuff, Special!

LaurelB August 3, 2013 at 7:30 am

I'd love to send this letter, but I don't have access to a printer. Does anyone have Dr. Unger's email address? I tried to google it, but could not find it. Thanks.

JohnnyD August 3, 2013 at 8:47 am

"Unger Dr. Beth" <eru0@cdc.gov>

Sasha August 3, 2013 at 8:56 am


JohnnyD

"Unger Dr. Beth" <eru0@cdc.gov>

Thanks, Johnny, that was useful – I've just sent my email.

Ember August 3, 2013 at 2:56 pm


SpecialK82

Maybe some docs need to be in on the meeting. I think the most important point would be to get people that she respects at the table, specifically researchers that understand how to set up study designs.

Dr. Unger should know that using these tests to confirm ME is endorsed in the ME Primer by clinicians and researchers on the ME International Consensus Panel:

Carruthers, Bruce M, MD, CM, FRCPC; clinician: internal medicine with focus on ME
Independent, Vancouver, British Columbia, Canada

De Meirleir, Kenny L, MD, PhD; clinician and researcher: physiology & medicine
Professor: Physiology and Medicine, Vrije Universiteit Brussel, Belgium
Director: Himmunitas Foundation, Brussels, Belgium

Klimas, Nancy G, MD; clinician and researcher: microbiology, immunology,allergy
Professor of Medicine and Director: Institute for Neuro-Immune Medicine, Nova Southeastern University, Ft. Lauderdale-Davie, Florida
Director: GWI and CFS/ME Research Center, Miami Veterans Affairs Medical Center, Miami, Florida, USA

Broderick, Gordon, PhD; researcher: systems biology, mathematical immunology, computational genomics – ME, CFS, Gulf War Illness (GWI)
Associate Professor: Pulmonary Medicine, Faculty of Medicine & Dentistry, University of Alberta, Edmonton, Alberta, Canada

Mitchell, Terry, MA, MD, FRCPath; clinician:internal medicine – pathophysiology and haematology
Retired clinical haematologist with 28 years of experience of ME and chronic fatigue syndrome, Suffolk, UK

Staines, Don, MBBS, MPH, FAFPHM, FAFOEM; public health medicine, occupational and environmental medicine, researcher
Public Health Physician: Gold Coast Public Health Unit, Robina, Queensland
Associate professor: Faculty of Health Sciences and Medicine, Bond University, Robina, Queensland
Faculty of Medicine, Griffith University, Southport, Queensland, Australia

Powles, A C Peter, MBBS, FRACP, FRCPC, ABSM; clinician: internal medicine: sleep medicine, respirology
Professor Emeritus: Division of Respirology, Department of Medicine, McMaster University, Hamilton, Ontario
Sleep Disorders Consultant: St. Joseph's Healthcare Hamilton, Ontario, Canada
Diplomate: American Board of Sleep Medicine

Speight, Nigel, MA, MB, BChir, FRCP, FRCPCH, DCH; paediatrics
Retired clinical paediatrician with many years of experience of ME and chronic fatigue syndrome. Durham, United Kingdom

Vallings, Rosamund, MNZM, MB, BS, MRCS, LRCP; clinician: primary care with focus on ME
Howick, New Zealand

Bateman, Lucinda, MS, MD; clinician: internal medicine with focus on ME & FM
Fatigue Consultation Clinic, Salt Lake City
Utah hospital affiliation: Salt Lake Regional Medical Center
Adjunct Instructor: Departments of Anesthesiology and Family and Preventive Medicine, University of Utah, Salt Lake City, Utah, USA

Bell, David S, MD, FAAP; clinician and researcher: paediatrics
Retired clinical paediatrician with many years of experience of ME and CFS, Lyndonville, New York
Department of Pediatrics, State University of New York, (SUNY – Buffalo) New York, USA

Carlo-Stella, Nicoletta, MD, PhD; clinician and researcher: immunology, immunogenetics of ME
Azienda Ospedaliera della Provinca di Pavia, Pavia
Primary care private practice with focus on ME, Pavia, Italy

Chia John,MD; clinician and researcher:internal medicine – infectious diseases, immunopathogenesis
Clinical assistant professor: Harbor-UCLA Medical Center, University of California, Los Angeles, CA
Director: EV Med Research, Lomita, California, USA

Darragh, Austin, MA, MD, FFSEM (RCPI, RCSI), FRSH, FI Biol I (Hon); clinician and researcher: endocrinology
University of Limerick, Limerick, Ireland

Gerken, Anne, MB, BS, D ObstRCOG, FRCPath: clinical microbiologist
Retired consultant microbiologist with many years of experience working with ME, Suffolk, United Kingdom

Jo, Daehyun, MD, PhD; clinician and researcher: pain and anesthesiology
Director: Pain Clinic, Konyang University Hospital, Daejeon
Professor: Department of Anesthesiology and Pain Medicine, Konyang University, Daejeon, Korea

Lewis, Don, MD; clinician: primary care with focus on ME
Donvale Specialist Medical Centre, Donvale, Victoria, Australia

Light, Alan R, PhD; researcher: Physiology, neuroscience, medical neurobiology and neuroanatomy, mechanisms of pain & fatigue
Professor: Anesthesiology and Neurobiology and Anatomy; Molecular and Cellular Neuroscience, University of Utah School of Medicine, Salt Lake City, Utah, USA.

Light, Kathleen C, PhD; researcher: behavioral medicine – physiological dysregulation in chronic pain and fatigue disorders, behavioral factors in cardiovascular disease, health benefits of family support, minority and women’s health issues
Professor: Anesthesiology and Psychology, University of Utah School of Medicine, Salt Lake City, Utah, USA.

Marshall-Gradisnik, Sonya, PhD; researcher: immunology -natural killer cells, vasoactive neuropeptide dysfunction and receptor expression, T cell regulatory dysfunction
Professor: School of Medical Sciences, Griffith Health Institute, Griffith University, Southport, Australia

McLaren-Howard, John, DSc, FACN; clinical biochemistry, biochemistry of nutrition, biochemical features of ME, mitochondrial dysfunction, vascular disease & intestinal dysbiosis
Fellow: American College of Nutrition
Director: Acumen Medical Limited, Tiverton, Devon, United Kingdom

Mena, Ismael, MD; nuclear medicine
Director: Imagenologia Funcional Cerebral, Department of Medicina Nuclear, Clinica las Condes, Santiago, Chile
Professor Emeritus: Radiological Sciences, UCLA School of Medicine, California, USA
Doctor Honoris Causa: University, d'Auvergne, France

Miwa, Kunihisa, MD, PhD; clinician and researcher: internal medicine: cardiology, cardiovascular physiology
Director: Miwa Naika Clinic, Toyama, Japan

Murovska, Modra, MD, PhD; researcher: virology, medical microbiology, molecular biology
Director: A. Kirchenstein Institute of Microbiology and Virology, Riga Stradins University, Riga, Latvia
Associate Professor: Riga Stradins University, Riga, Latvia

Stevens, Staci, MA; exercise physiology
Director: Workwell Foundation, Ripon, California, USA

With Dr. Broderick's having relocated to Florida, eight of these authors are based in the US. Drs. Klimas and Bateman are also involved in Dr. Unger's multi-site study.

taniaaust1 August 4, 2013 at 2:10 am

A big thank you to Mark and the others who have worked on this. I think it is sooo important to be pointing out the issues with studies sooner rather then later.

Questus August 4, 2013 at 7:35 pm

Sorry if I missed the link, but is there a way to sign the petition online?
Thanks for sharing this Mark.

Best,
Questus

Sasha August 5, 2013 at 2:57 am


Questus

Sorry if I missed the link, but is there a way to sign the petition online?
Thanks for sharing this Mark.

Best,
Questus

Hi Questus – it's not a petition, it's a letter – the email address was posted here:

http://forums.phoenixrising.me/inde…ing-advocates-insist.24547/page-2#post-375432

Nielk August 7, 2013 at 6:33 am

From the CDC website regarding the ME/CFS multi site study:


This will help us to describe the differences and similarities among CFS patients. 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.

How can they accurately sub group us if they don't take the relevant tests that are critical in the diagnosis of the disease?

What is their ultimate aim with this study? They are basically taking current patients from seven clinical sites. They are having them fill out a complete questionnaire. They are "studying" them, in a fashion that is not clear or disclosed to us.

I am afraid that the result of this study will show that there is very little to unify us. It will show that we are just a conglomerate of so many different issues resulting in "fatiguing" type of illnesses. It is not a real disease, they will say, it is just a syndrome of many symptoms which need to be treated symptomatically.

The reason why this is my fear is that if they were truly concerned in finding "the underlying biology', they would concentrate on the testing that have shown in past peer-reviewed studies, abnormalities in ME/CFS patients. They would also include severely affected patients as well as children.

Bob August 7, 2013 at 7:18 am

The CDC are not great at keeping the community up to date with exactly what they are doing, but they have given out some information about their ongoing study.
The CDC don't seem to be engaging continuously with the wider ME community, but they are engaging with significant parts of the ME community, especially the experts and clinicians who are involving in their study.

It's a mistake to say that the CDC are only using questionnaires.
Their study is evolving and seems to be open-ended, and they have now gone beyond questionnaires, and physician reports, and are looking at some biomarkers.

Beth Unger seems to recognise that heterogeneity is the biggest problem. And she's looking for data to find well-defined subsets. Finding subsets seems to be her mission. I can't fault that mission.

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

Importantly, and very relevant to this thread, they are already taking the study to a new level, and looking at biomarkers. They are taking DNA/RNA samples, and testing for morning cortisol levels. And also doing cardiopulmonary testing during exercise tests, and cognitive testing post-exercise. (Although currently these are planned to be one-day and not two-day tests.)

So, to summarise, my understanding is that the CDC have already started carrying out further tests including:

  • DNA/RNA testing. (I'm not aware of the exact details.)
  • Morning cortisol levels.
  • Cardiopulmonary testing during exercise tests (one-day testing)
  • Cognitive testing post-exercise (one-day testing)

At the most recent CFSAC meeting, Beth Unger also expressed an apparent willingness to incorporate post-exertion resting heart-rate into the study, although she didn't make it a firm commitment.

This is my understanding of it anyway. I may have misinterpreted something, because I've gleaned the information mainly from the chatter in CFSAC meeting videos.

I think prompting the CDC to look at two-day exercise testing is helpful, but keep in mind that Dr Snell has had some mixed results from two-day exercise testing, and has only carried out relatively small studies, and he has suggested that his work has not been reliably replicated by others. So two-day exercise testing may or may not prove to be as helpful as we hope.

My own interpretation is that Beth Unger and her team are moving in exactly the right direction, but still have a very long way to go. I don't think we should assume that Beth Unger is like previous CDC employees. She seems to be wiping the slate clean, and starting from scratch and approaching ME/CFS with an open mind, and basing her work on the data outcomes. This is absolutely the best way to go about it. But it's something that should have been done 30 years ago, so the CDC is behind schedule. My own interpretation is that Unger is taking her job seriously, and treating this illness seriously. Of course, I might be wrong, and perhaps I have a tendency to be over-optimistic, but I'm trying to be fair minded, and base my opinions on my interpretation of the evidence. The evidence suggests to me that she is doing the right stuff, but has a long way to go, and the CDC is at least 30 years behind schedule. I'm sure that others might disagree with me.

I've previously posted about these issues in a jumble of posts, if anyone is interested in reading further (but I've copied the essential information into this post):
http://forums.phoenixrising.me/inde…ase-definitions-now.23217/page-12#post-367643
http://forums.phoenixrising.me/inde…-war-illness-and-cfs.23958/page-2#post-367368
http://forums.phoenixrising.me/inde…ase-definitions-now.23217/page-10#post-366821

Firestormm August 7, 2013 at 7:21 am

Bob thank you for that. I had asked what they were actually up to with the testing before on this thread I think. All tends to get muddled across the forums. Very useful summary :)

Bob August 7, 2013 at 7:30 am


Firestormm

Bob thank you for that. I had asked what they were actually up to with the testing before on this thread I think. All tends to get muddled across the forums. Very useful summary :)

Their study might have evolved even further now. I'm basing my info on what was available at the last CFSAC meeting, whenever that was.

Nielk August 7, 2013 at 9:24 am

Bob,

I guess we have different perspectives, looking at the same data.

So far, from my understanding the CDC first phase of the study has been accomplished.
This included 450 patients from 7 clinical sites.
It involved:

-physical exam (not clear if this was done by the clinicians or CDC reps)
-patient questionnaires – including measure of fatigue, sleep, pain and function
-data abstraction of medical records by clinic personnel

They have collected all (95%) of the data and analyzed it, comparing the different sites and comparing some of the data with different illnesses.

The second phase, we are told, involves:

From all clinical sites
-saliva morning cortisol collection (??? this will find subsets?)
-blood DNA & RNA (sounds important but, what is it?)

Additional studies at some clinics:

-comparing healthy controls
-cognition and exercise testing

From CFSAC:

"final dataset will allow comparison of instruments measuring domains of CFC illness"

I wish someone can explain to me what this means exactly.

I don't have anything personal against Dr. Unger. I don't think that she has the power to "wipe the slate clean". I think that she is just doing the job she is told to do.

Why is the CDC totally ignoring all the scientific studies that are already out there?
They give the impression that this is a legitimate and important study because they are involving patients who are part of major clinical practices. In what way, are they going to find a biomarker for ME/CFS with this study as it is?

I don't feel that heterogeneity is the biggest problem. I feel that finding a biomarker and diagnostic criteria are. Many other illness are heterogenic, that doesn't necessarily mean that it is not one disease. Any multi-system illness will be heterogeneous. Lupus, for example will appear totally different in each patient. Separating the patients into different illnesses, would have been a major mistake.

Why am I so disillusioned with the CDC? Because they are totally ignoring the fact that we have the CCC and the ICC. They are acting as if they don't exist. I don't have any medical or science background but, from my knowledge of the history of this disease, what they are doing now in this study, does not make sense to me.

Firestormm August 7, 2013 at 9:33 am

Nielk just confirm for me that they are assessing patients using their own (CDC) criteria. Thanks.

Nielk August 7, 2013 at 9:47 am


Firestormm

Nielk just confirm for me that they are assessing patients using their own (CDC) criteria. Thanks.

According to Dr. Unger, the patients they are studying are the ones that each clinician has diagnosed with CFS, Post Infective Fatigue (?),ME – it doesn't say by which criteria.

Bob August 7, 2013 at 10:16 am


Nielk

According to Dr. Unger, the patients they are studying are the ones that each clinician has diagnosed with cfs, post viral infection, ME – it doesn't say by which criteria.

No particular criteria is necessary for the study. The clinicians just have to diagnose the patient in their own way, according to their expert knowledge. I expect that each patient will subsequently be diagnosed as per various criteria, for the purposes of gathering extra data.

Firestormm August 7, 2013 at 10:30 am


Bob

No particular criteria is necessary for the study. The clinician just has to diagnose the patient in their own way. I expect that each patient will subsequently be diagnosed as per various criteria, for the purposes of gathering extra data.

This was to have been my next comment. I hope that the data gathered will be used in 'research' as we might better understand it; and those who are sub-grouped in this initial business are then studied under the microscope as it were. I may well be wrong of course.

Bob August 7, 2013 at 10:32 am

I'm assessing Beth Unger's progress relatively from a standing start, and not from where we want the CDC to be. I'm not trying to pretend that everything at the CDC is wonderful, but there has been change, and I'm quite impressed with what I've seen recently, in terms of attitude. I imagine that many people will be shouting at their computers whenever I say anything positive about the CDC, and I totally understand that.

Of course there is a huge distance that they need to travel, but this is not Beth Unger's fault. So I'm assessing her progress from a standing start, and not from where the CDC should be. And I'm not suggesting that we shouldn't be critical of the CDC, and or that we shouldn't put pressure on them. We should be critical, and we should put pressure on them. I just think that it's helpful to observe what they are actually doing.

The CDC currently appears to be very resistant to suggestions from the ME patient community, but I think this is because they have a very bureaucratic and specific way of doing things, and their plans take a long time to implement. I think this can give the appearance that they are not listening and that they don't care. But I think we should be aware of their bureaucratic processes, and not assume that they are ignoring our community to spite us. I saw evidence of flexibility, engagement and receptiveness, from Beth Unger at the recent CFSAC meeting, although it wasn't obvious.

Before Beth Unger, I had no respect for the CDC at all. And it took me a long time to learn what Beth Unger's approach would be. Only recently have I really learned what her approach is, and I've only learned it by listening carefully to what her team have said at the CFSAC meetings.

Like I said earlier, I may well have misinterpreted, and I may be far too optimistic, but I am optimistic about their direction of travel. Of course, they yet have to prove themselves. I'm also aware that many will strongly disagree with my assessment.

Nielk

I don't have anything personal against Dr. Unger. I don't think that she has the power to "wipe the slate clean". I think that she is just doing the job she is told to do.

Beth Unger seems to be approaching the subject without preconceived ideas, and she has stated that she is following the data. I think that's the best way for her to go about it. It really does seem to me that she's made a fresh start of ME/CFS at the CDC. I'm basing this on what she's said, and on the project that they are carrying out. She has a very long way to go, but that's not her fault. What she is doing now should have been done 30 years ago.

Nielk

Why is the CDC totally ignoring all the scientific studies that are already out there?

My understanding is that it is because they require a certain standard of evidence. Yes, there is research out there, but is any of it conclusive? I'm not aware of any conclusive top-quality research in terms of objectively defining ME/CFS. Are you? There is some evidence re exercise testing, tilt-table tests, brain scans and immune activity, but none of it is of a high enough standard to be widely accepted, as far as I am aware. Unless I'm forgetting something.

The CDC needs data from studies with large numbers of participants. And any objective biomarkers need to be reliably reproducible in further research studies. The CDC have now started looking at large numbers, and have also started looking at potential biomarkers. But, yes, they've yet to demonstrate exactly what they are studying in terms of biomarkers.

Beth Unger has acknowledged that she's yet to get to grips with PEM, in terms of defining it for research purposes, and she's acknowledged that it could be a useful biomarker if she is able to define it to her satisfaction for research purposes. Sure, this sort of thing seems very basic to us, but she's got to define it in a way that is reliable and replicable in research studies. Should she use self-reported questionnaires, immune biomarkers, exercise testing, or something else? What reliable biomarkers are there for PEM? Is there any top quality research that defines reliable biomarkers for PEM or PENE? I'm not aware of any. Dr Snells recent research is very promising, but it's just one small study.

Nielk

They give the impression that this is a legitimate and important study because they are involving patients who are part of major clinical practices. In what way, are they going to find a biomarker for ME/CFS with this study as it is?

I get the feeling that it's an open-ended, evolving, exploratory study. So far, there are some potentially decent biomarkers involved, although the details are sketchy. Exercise testing, post-exertional cognition testing, DNA/RNA analysis, and post-exertional resting heart rate testing seem like pretty good objective biomarkers to be starting with. Two-day exercise testing, immune signatures, viral testing and protemics are maybe the next step.

Likpin is doing an extensive viral and proteomic study, and it is something that the CDC should have been doing years ago. If we compare Lipkin's study with the CDC study, then the Lipkin study puts the CDC to shame. But I'm assessing Unger from a standing start. I hope that the CDC will be funding research similar to Lipkin's after they have done their current basic biomarker research.

Yes, the CDC is doing far too little, far too late. But I'm not assessing Unger on where I want her to be. I'm assessing her on where she is, based on a standing start. So I'm trying to assess her motivation, rather than her accomplishments.

Nielk

I don't feel that heterogeneity is the biggest problem. I feel that finding a biomarker and diagnostic criteria are. Many other illness are heterogenic, that doesn't necessarily mean that it is not one disease. Any multi-system illness will be heterogeneous. Lupus, for example will appear totally different in each patient. Separating the patients into different illnesses, would have been a major mistake.

I think that many of us would accept that CFS may not be a single disease, and some of our community would like ME to be distinguished from CFS. Unger is attempting to identify subsets. She has said that she is open minded to defining ME separately, if her data leads her that way. Without getting to grips with heterogeneity, if there is any, and defining subsets, then biomarkers and objective diagnostic criteria would be impossible to define. Defining subsets is the best way to start, or biomarkers will be impossible to find.

Nielk

Why am I so disillusioned with the CDC? Because they are totally ignoring the fact that we have the CCC and the ICC. They are acting as if they don't exist.

I think that the CDC has accepted that research should be carried out with Fukuda and CCC, haven't they? The reason that they are partially ignoring the CCC is that they don't believe that it is evidence based. Not to the standard that they require. So they have set about finding subsets for themselves, using their newly gathered data. Whether it's the right or wrong approach, the CDC requires a certain quality of empirical evidence.

Nielk

I don't have any medical or science background but, from my knowledge of the history of this disease, what they are doing now in this study, does not make sense to me.

It makes sense to me. And I like what they are doing. It's just not enough, and not fast enough.
I like what I've heard Beth Unger say recently.
She does sometimes seem resistant to suggestions from the ME community, but I don't think she ignores us.

Anyway, it's just my own assessment, and I know that many won't agree, but I haven't seen any evidence of cynicism from Beth Unger.

Michelle August 8, 2013 at 12:55 am

Forgive me for butting in my 2 cents since over the years here at PR my comments have become extremely sporadic due to the Damn Disease (not that they would be worth more than the aforementioned 2 cents anyway ;-) ), but I cannot agree with Bob more. All CCC and ICC give us is a dim picture that some very good clinicians & researchers have been able to cobble together using a relatively tiny bit of money to do tiny studies that have not been adequately replicated for the purposes of helping other clinicians trying to provide some sort of support for patients with a disease that cannot yet be treated beyond palliative care. None of the diagnostic testing mentioned in CCC and ICC (or Fukuda, for that matter) has been clinically validated, i.e. they have been studied in thousands of patients and replicated so consistently that almost everybody agrees they will reliably diagnose (or assist in treatment of) this disease. There are simply all the authors of those criteria had/have at the present. But they do not have nearly enough data to be definitive because they have not had the funding nor the infrastructure to do the studies needed to produce enough data one way or the other (thanks NIH and CDC!). We simply do not know with anything close to certainty that CCC or ICC or Fukuda can definitely diagnose this/these illness(es).

However the CCC/ICC group do have years of clinical experience, which Dr Unger and the current CFS program at CDC appear to acknowledge and are trying to utilise with a far bigger cohort than any one of these clinician-researchers could muster on his or her own. Moreover each of these clinicians have their own approach to diagnosing this disease. By collecting data from their patients (who have already ostensibly been diagnosed using CCC/ICC since all the clinicians in this study were involved in creating those criteria) and comparing/contrasting this data, it will either show that CCC/ICC are good at distinguishing this disease from depression and other co-morbidities, or it will show that there are tests/symptoms that are more helpful than those listed in CCC/ICC. It may be that NK cell function testing or 2-day CPET only catches a subgroup and misses a huge swath of patients that has hitherto been missed because of the tiny cohorts used in testing thus far. It may be that vertigo or delayed gastric emptying or some other random symptoms end up being more definitive than NK cell function or CPET (I strongly doubt it but without a large enough data set, who knows?). But the data from this CDC study will be far more robust than anything CCC, ICC, or Fukuda can provide.

If we do not deal with the issue of heterogeneity, we will get no where (we HAVE gotten no where). Whether this is one disease with multiple presentations or multiple diseases with similar presentations, we must, must, must start subgrouping. It's what Fukuda called for nearly 20 years ago. It's what just about every one of the clinician-researchers we talk about (Peterson, Klimas, etc.) mention at every ME/CFS conference they speak at — big or small. It has been THE problem impeding progress in figuring out biomarkers and establishing diagnostic criteria with which every researcher can agree and — more importantly — use for further research (as well as finally put a cork in the psychogenists!). And from what I've seen of Unger's CDC study, it appears to be finally — FINALLY!! — addressing this issue (30 years late but I'd prefer it now than in another 30 years).

I agree that there should absolutely be transparency in how CDC is carrying out the test and would think CFSAC should be seeing to that (note I say "should"; given the last meeting, god only knows what they're doing). While I'm cautiously hopeful about this big study, I haven't forgotten the last 30 years (half of which I've spent wasting away my 20s and 30s). That they have much to prove to us is an understatement. But, aside from some sort of an exercise and cognitive stressor, I'm rather agnostic on what tests CDC must use. I think they need to have the flexibility to go where what they find (i.e. data) tells them would be the best place to go so that we don't spend precious time and money chasing theories that look promising but just don't produce consistent findings.

Sorry. I'll return to radio silence. I get way too wordy when I comment (though it probably helps me get to sleep to write this down rather than spend hours talking to myself about what I would say if I was going to comment…yes, that IS sad…lol).

Bob August 8, 2013 at 6:35 am

Michelle, I agree with nearly all of your post, but I wouldn't have quite used your wording with the following:

Michelle

All CCC and ICC give us is a dim picture that some very good clinicians & researchers have been able to cobble together using a relatively tiny bit of money to do tiny studies that have not been adequately replicated for the purposes of helping other clinicians trying to provide some sort of support for patients with a disease that cannot yet be treated beyond palliative care.

I think you make a half-valid point here, and I agree that without biomarkers and treatment, that the CCC and ICC are of limited value. But they are based on expert observation of patients, and I think these criteria have an important purpose. The CCC is now widely being used for research, and it's an extra way to subset patients, which might prove to be very helpful. I also think it's helpful to define a disease, or a subset of patients, in a more precise way than the more inclusive CFS criteria, based on careful clinical observation. It hopefully will give the illness and patients more credibility, over time, and it better informs clinicians about the nature of the disease.

But yes, proper empirical data, based on objective observations of large number of patients, has the potential to transform the field.

But I acknowledge that I have a very optimistic view of the future of CDC. And I make the assumption that the CFS division of the CDC is no longer corrupt. It might be the case that the CDC produces absolutely nothing useful. Their study is not yet ambitious enough, and they appear as if they are dragging their feet. They have to prove themselves.

Nielk August 11, 2013 at 1:58 pm


Bob

But I acknowledge that I have a very optimistic view of the future of CDC. And I make the assumption that the CFS division of the CDC is no longer corrupt. It might be the case that the CDC produces absolutely nothing useful. Their study is not yet ambitious enough, and they appear as if they are dragging their feet. They have to prove themselves.

Bob – Can I ask you what your optimism of the CDC is based on? In what way have they proven to you that they have changed?

Bob August 11, 2013 at 3:59 pm


Nielk

Bob – Can I ask you what your optimism of the CDC is based on? In what way have they proven to you that they have changed?

Well, first of all, it is only my own interpretation, and I may well have got it completely wrong.

I'm basing my views on the current work the CDC are carrying out, and on what Beth Unger has said recently.

In my opinion, the CDC are now doing the essential research that they should have carried out 30 years ago.
If we look at Beth Unger's term in office from the point of view of a completely fresh start at the CDC, then I think she is doing exactly what she should be doing.
Their study has started as an apparently basic project, but the basics needs doing, because of the CDC's history.
Unfortunately Beth Unger had to start from basics, in terms of collecting empirical evidence and data.
But the numbers of patients involved in the study (and the sources of the samples) means that it's not as basic as it appears.
We want her to look for biomarkers, and she has now begun to do that.
And they are looking at some potentially very helpful biomarkers. (Although the usefulness of the results depends on the exact methodology and competency, and the potential for the study to continue to evolve as necessary.)
Hopefully their investigation of biomarkers will continue to evolve, and will be eventually comprehensive.

Beth Unger is properly engaging with the ME patient community, by enrolling the CFS/ME expert clinicians into her study.
She is now collecting data. Big data is precisely what we need, if we are to make progress, and it's something that only the government agencies are able to fund.
She has also said that she is open-minded to the nature of CFS and ME, and any subsets, and that she will follow the data.
The data is being collected from clinicians who most of us respect.
I can't fault her approach, except to say that it's too little too late, but that's not her fault.

I believe Beth Unger may be making a fresh start, and that we should give her a chance to carry out her research, which takes time.
It will take time for the research to be carried out, but the study seems to be open-ended, and they are constantly adding on new aspects of the study, looking at biomarkers. It seems she wishes to continue with the research until they get some useful results.

We are annoyed because the CDC constantly appear to be dragging their heals. We want them to adopt the CCC/ICC and to ditch stuff about CBT/GET. But if we look at it from Beth Unger's point of view, she is working for a huge bureaucracy, and she needs empirical data to make any evidence-based changes. And that's what she's looking for. Unfortunately, currently, CBT & GET have some evidence behind them, so it's probably difficult for the CDC to disregard them, especially because nothing else is widely available to patients.

Yes, we should put lots of pressure on them to get it right, but I'm not sure if we should automatically assume that Beth Unger, and her team, are either corrupt or incompetent. Bureaucracies take a little time to change. Think of the CDC as an oil tanker turning around. I think we need to give Beth Unger another year or two of data analysis before we can judge her work. But what I've seen so far, I really like.

If I was in Beth Unger's position, I would be doing exactly what she is doing. I'm not an expert, and perhaps I'm wrong, but I think it's a perfect approach. I would then move on to look for more and more biomarkers. I hope that once the basic research has been carried out that the CDC will then move on to the sort of stuff that Lipkin is doing, using her existing patients samples from the expert clinicians.

My only motivation for posting something positive about the CDC is that I think we should not automatically assume that the CDC is the same as it was. Based on what I've seen recently, I think it's changed. I may well be wrong.

Emma August 19, 2013 at 10:32 am

Letter sent! Have also asked a few friends.

Bob August 20, 2013 at 5:43 pm

Deborah Waroff interviews Gunnar Gottsschalk (who runs Dr Peterson's research lab) about the CDC study.

Gunnar says that Dr Peterson is involved in the CDC study, and that the data for about 75 of Dr Peterson's patients is included.

He seems quite positive and enthused about the project, but not a great deal of detail is discussed.

He doesn't seem to be aware that the CDC are planning, or have already started, some collection of biological/objective data, but perhaps that is because the CDC are using a smaller selection of the entire cohort for that part of the trial. So perhaps they aren't using Peterson's patients for biological/objective data collection.

Keeping that in mind, Gunnar says he hopes that the CDC will now incorporate a sample collection for analysis into the project.

They are moving onto Phase II of the trial.

He also hints (it's not too clear) it will be an open-ended study, as I hope it will be, and that it might evolve in terms of the methodology.

Gunnar Gottsschalk is Research Coordinator for Sierra Internal Medicine and Simmaron Research Inc.

http://www.youtube.com/watch?v=0aYHxJIp4ds

August59 August 22, 2013 at 3:13 am

The CDC is just now admitting that there are 10,000 more cases of Lymes disease than originally thought, but this is mostly blamed on very poor testing procedures to start with. Physicians not believing the patient has Lymes and then of course the physician does not report the Lyme case as they are required to do

Most cases of Lymes are in a chronic state, which most physicians think a couple of weeks of antibiotics will cure!!!!

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