Invest in ME Delivers Scathing Response to P2P Report, Suggests Hidden Agenda

Invest in ME, a UK charity whose primary focus is on biomedical research into the causes, mechanisms, treatments for ME has made its response to the P2P Draft Report - and it is a delight to read.

The charity rightly pointed out that it was completely contradictory to declare ME/CFS as not psychogenic in one section of the Report while recommending further investigation of psychological therapies as treatments in another. Invest in ME suggested that by doing so the P2P panel had a "hidden agenda."

I would say that the agenda was not particularly well hidden. All of the speakers addressing the Session 2 Key Question ("Given the unique challenges to ME/CFS, how can we foster innovative research to enhance the development of treatments for patients?") were either psychologists or psychiatrists. 

Apart from the obvious bias in choosing speakers for this important session, the very fact that the PACE trial - with its flawed methodology and questionable outcome - was included at all in a review that was supposed to be "scientifically rigorous" is a clear indication that the P2P had something in mind from the very start.

_________________________

Invest in ME

PO Box 561, Eastleigh SO5O OGQ, Hampshire, UK

Telephone: 02380 251719 – 07759 349743

Web: www.investinme.org 

Email: info@investinme.org

Charity Nr 1114035

INVEST IN ME RESPONSE TO NATIONAL INSTITUTES OF HEALTH PATHWAYS TO PREVENTION WORKSHOP: ADVANCING THE RESEARCH ON MYALGIC ENCEPHALOMYELITIS/ CHRONIC FATIGUE SYNDROME DRAFT EXECUTIVE SUMMARY

Invest in ME would like to thank the NIH for the opportunity to submit comments on this draft report [1]. Invest in ME (IiME) is a UK charity (charity number 1114035) established in 2006 to educate the public and media about Myalgic Encephalomyelitis (ME) and raise funds for fundamental biomedical research into ME. We have links internationally and are current chair of the European ME Alliance, an umbrella organisation of 13 national European patient groups working together to improve awareness of ME. IiME have so far organised nine annual international ME/CFS conferences and four research colloquiums in London, UK, to allow researchers, clinicians, patient groups and patients to learn about the latest research, form collaborations and share experiences to advance research into this condition.

The charity strongly believes in international biomedical research collaboration and have initiated possibly the two most important research projects for ME in the UK – a gut micriobiota study [2] and a project leading to a UK clinical trial using rituximab to treat ME patients [3].


In the UK patients prefer to use the term ME to differentiate from the term CFS which is favoured by those using the Oxford criteria or who wish to use as broad a possible an umbrella to describe their particular interests. In this document we’ll use ME/CFS from here on to match your terminology and also that used in the Canadian Consensus Criteria for which IiME is UK distributor of the printed version).

Below are comments that we have concerning the draft document. We conclude this document with a summary and our recommendations.


Lines 2-4:

“Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a chronic, complex, multi-faceted condition characterized by extreme fatigue and other symptoms that are not improved by rest. 

IiME comment: 

It may be better to replace line 3 with – “…faceted condition characterized by multiple symptoms that are not improved by” We are unsure why “extreme fatigue” is highlighted here and all other symptoms are bundled together as “other symptoms” especially when later in the document fatigue is recognised as not necessarily being the main symptom.

Lines 7-11:

“ME/CFS results in major disability for a large proportion of the people affected. Limited knowledge and research funding creates an additional burden for patients and health care providers. Unfortunately, ME/CFS is an area where the research and medical community has frustrated its constituents, by failing to assess and treat the disease and by allowing patients to be stigmatized."

IiME comment: 

We strongly agree that ME/CFS leads to major disability and patients feel frustrated at no medical discipline taking responsibility for this condition despite it being classified as a neurological illness since 1969. However, the NIH have to take a portion of the responsibility for this state of affairs as “limited knowledge and research funding” directly causes the ignorance amongst the healthcare profession and leads to failure “…to assess and treat the disease and by allowing patients to be stigmatized”. NIH funds research and therefore carries some of this responsibility for the state of affairs.

Lines 38-43:

“The Oxford criteria (published in the Journal of the Royal Society of Medicine in February 1991) are flawed and include people with other conditions, confounding the ability to interpret the science. The lack of a consistent, specific, sensitive diagnostic test and set of criteria has hampered all downstream research on pathogenesis and treatment, causing harm and preventing ME/CFS from being considered as a distinct pathologic entity.“

IiME comment: 

We agree with the statement that the Oxford criteria “hampered all downstream research on pathogenesis and treatment, causing harm and preventing ME/CFS from being considered as a distinct pathologic entity”. We have stated for many years that the Oxford criteria are flawed for ME research and research related to ME which has used these criteria need to be ignored as evidence for this document.

Lines 51-53:

“Small sample sizes, the inclusion of participants with differing symptoms across studies, and the lack of inclusion of the homebound, rural residents, and a research focus on men limits the applicability of current studies.” 

IiME comment: 

Really those funding bodies including the NIH, the UKMRC, Departments of Health etc. must take responsibility for this state of affairs.

Lines 55-57:

“All this leads to inconclusive results and a lack of knowledge of ME/CFS prevalence (i.e., how many people have ME/CFS), incidence (new cases per year), and potential causes and treatments.” 

IiME comment: 

A study by Nacul at al. shows the variation in prevalence rates of 0.03 to 0.19% in three regions in England (UK) depending on criteria used. The overall estimated minimal yearly incidence rate was 0.015%. This study was not part of the review as it did not seem to fit your criteria [4].

Lines 58-59:

“Fatigue has been the defining focus of recent research, but many other symptoms need to be explored, primarily neurocognitive deficit (“brain fog”), post-exertion malaise, and pain.” 

IiME comment: 

We agree - which makes it stranger that the report specifically only highlighted fatigue in line 3. Not all ME/CFS patients find fatigue as their main or most debilitating symptom and too much research has been performed concentrating on this one symptom alone.
Fatigue is a symptom of numerous conditions and it is not specific for ME/CFS. Post Exertional Malaise is a hallmark symptom of ME/CFS and it has been shown in two day VO2Max exercise testing and is accepted as objective proof of physical disability. Larger studies are needed to find out whether this could be used as a biomarker and to find out whether there are clear subgroups for reasons for the drop in performance as indicated by the Keller et al. study [5, 6, 7].

Lines 65-73:

“Often, patients with ME/CFS are labeled as lazy, deconditioned, and disability-seeking; this hampers scientific progress. Both society and the medical profession often treat patients with ME/CFS with disdain, suspicion, and disrespect. Patients are frequently treated with psychiatric and other inappropriate drugs that may cause harm. Patients usually have to make extraordinary efforts, at extreme personal costs, to find a physician who will correctly diagnose and treat ME/CFS symptoms. In addition to high medication costs, the debilitating effects of ME/CFS can result in financial instability due to the physical consequences of the illness (e.g., the loss of employment, home, and other basic necessities). All of these factors contribute to the poor quality of epidemiologic studies.” 

IiME comment: 

All of these factors can be attributed to the lack of any serious strategy to resolve the illness – which then allows flawed research to be funded and which also leads to misinformation and poor education about this illness being perpetuated. Listen to the patients – an old adage but one which has until now not echoed in those rooms where decisions are made about research into ME/CFS.

Lines 92-95:

“Although psychological repercussions (e.g., depression) often follow ME/CFS, this is not a psychological disease in etiology. A multitude of symptoms are associated with ME/CFS, with substantial overlap with other pathologic diseases (e.g., fibromyalgia, major depressive disorder, and a variety of chronic pain or inflammatory conditions).”

IiME comment: 

Good to read it clearly stated that this is not a psychological disease. 

The World Health Organisation (WHO in Europe) has classified ME as a neurological illness since 1969. It is the proponents of the biopsychosocial paradigm that try to promote the notion that ME/CFS can be classified in two separate codes either as neurological or mental illness depending on the diagnostician’s opinion which is grossly misleading and contributes to the problems patients face at all levels of society [8]. However, care should also be taken not to add on co-morbid diagnoses such as fibromyalgia or mood disorders just because ME/CFS patients report pain or feel a bit down as these can form just part of the normal ME/CFS symptomatology.

Lines 95-97:

“Focusing on fatigue alone may identify many ME/CFS cases. However, this symptom taken in isolation fails to capture the essence of this complex condition.” 

IiME comment: 

Exactly. We entirely agree.

Lines 113-117:

“Existing treatment studies (cognitive behavioral therapy [CBT] and graded exercise therapy [GET]) demonstrate measurable improvement, but this has not translated to improvements in quality of life (QOL). Thus, they are not a primary treatment strategy and should be used as a component of multimodal therapy. Overall, agreeing on a case definition and clarifying comorbidities could launch bench-to-bedside science.” 

IiME comment: 

It is at this point that we begin to wonder about the real agenda. 

We strongly disagree with the statement that CBT and/or GET demonstrate measurable improvement that makes a real difference in patients’ lives. In fact a large study in Belgium that collected data of 1655 patients attending four reference centres between 2002 and 2004 demonstrated that participants’ physical capacity did not change, their employment status decreased and the percentage of patients living off sickness allowance increased at the end of such therapies [9]. 

Also a 2007 study by Knoop et al showed that “CBT leads to a reduction in self-reported cognitive impairment, but not to improved neuropsychological test performance. The findings of this study support the idea that the distorted perception of cognitive processes is more central to CFS than actual cognitive performance.”[10]. We are very concerned about the term multimodal therapy. What does it mean and is there any evidence for such a therapy being useful for ME/CFS? 

CBT and GET should not form any more part of a treatment strategy for ME/CFS than it is for other neurological illnesses such as MS or Parkinson’s disease for example. The lamentable (some would say farcical) PACE trial in the UK that used the Oxford criteria has conclusively demonstrated the total waste of money behind these ineffectual therapies. The emphasis should be on researching and treating the core illness and not just concentrating on comorbidities which could often be avoided if the condition was treated by knowledgeable physicians to begin with. 

We emphasise this point!

Lines 130-134:

“In general, little attention was given to how self-management may empower and improve health and QOL for patients with ME/CFS. Physicians are inadequately trained to instruct patients in self-management skills (e.g., pacing, realistic goals, physical self-awareness, basic rights, understanding emotions, exercise, relaxation), and there is a lack of data demonstrating the efficacy of self-management on health outcomes.” 

IiME comment: 

We totally disagree. 

ME/CFS patients have been self-managing for decades, by necessity, and are better at doing so than many other patient groups. Even very severely ill bed bound patients may often be looked after by family members in their own homes with little supervision from health care professionals or social services. It is not self-management skills that patients are looking for when they visit their doctors. They need honest information, advice, support and follow ups to ensure there are no missed diagnoses – and hope that the miserable record of proper research may be overturned in order to provide a future.
Support for practical matters such as education, employment, social care and help with benefits would be useful in the early stages of the illness to avoid mildly affected patients ending up becoming severely affected due to overexertion resulting from ignorance about ME/CFS or negligent advice. 

If the illness was taken seriously and patients treated with respect at first point of contact then there would be less need for treating some of the subsequent comorbidities. There needs to be a clear message to the research community that the NIH considers ME/CFS a physical disease and the peer reviewers and funding committees that decide upon grant applications should hold the same view.

Lines 134-138:

“The focus on exercise programs has further stigmatized and discouraged research participation. In many cases, lack of instructions or guidance for including graded exercise therapy often causes additional suffering, creating fear of harm from a comprehensive self-management program that may include some physical activity (e.g., mild stretching).” 

IiME comment:

Patients do not have fear of harm and they have nothing against common sense advice but they do object to proscriptive CBT and GET programmes that are patronising and based on flawed research. 

The group should also be aware of harms caused by CBT and GET. This aspect has been explored in a paper titled “Reporting of Harms Associated with Graded Exercise Therapy and Cognitive Behavioural Therapy in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome” by T. Kindlon and he states - “Across different medical fields, authors have placed a greater emphasis on the reporting of efficacy measures than harms in randomised controlled trials (RCTs), particularly of nonpharmacologic interventions.”[11]. 

Each chronically ill patient be it ME/CFS, cancer or any other illness learns to cope in their own way and the most important thing for them is to receive support and honest and factual information to be able to adjust to their lives accordingly in the absence of effective treatments or a cure. ME/CFS patients tend to prefer research into the core aspects of the illness so that the information given to them by doctors would be based on facts rather than opinion, assumptions or vested interests. There is no problem in recruiting patients for such research. As a charity that funds biomedical research into
ME Invest in ME can categorically state that recruitment for research and trials is no issue.

Lines 169-177:

“Research priorities should be shifted to include basic science and mechanistic work that will contribute to the development of tools and measures such as biomarker or therapeutics discovery. The following questions need to be answered:
• What is the pathogenesis of ME/CFS? What is the role of virologic mechanisms, especially herpes viruses? Does mononucleosis lead to ME/CFS in adolescents?
• What is the role of other pathogenic agents?
• Is this a genetic disease? Is there a gene-environment interaction?
• Is ME/CFS a spectrum disease?
• Are different pathways responsible for different symptoms?”

IiME comment: 

The research priorities should not just shift to include basic science and mechanistic work but this should be one of the main areas of research. Once there is a biomarker that is reproducible then the field could move forward quickly. The message of ME/CFS being a physical disease and not a psychological one should be kept in mind when committees and peer reviewers are chosen to decide upon grant applications.

Lines 178-185: Future Directions and Recommendations

“ME/CFS is a chronic, complex condition of unknown cause and with no cure. We have learned some about the mechanisms of the disease, but nothing has improved the lives of the patients. Overall, there has been a failure to implement what we already know for patients with ME/CFS while it steals their health and wellbeing.” 

IiME comment: 

The biggest failure in the whole history of ME/CFS has been the lack of anyone in authority taking responsibility for this area of medicine and patients have been left to manage as best as they can. In the UK the Medical Research Council (MRC) and those in the MRC controlling policy toward ME have been seriously negligent. The NIH must take its share of the blame also. 

Researchers need to know that there is funding for them to be able to commit their careers to researching this group of patients.

Lines 183-184:

“The subjective nature of ME/CFS, associated stigma, and the lack of a standard case definition has stifled progress.” 

IiME comment: 

We suggest this could be changed to – “The subjective nature of ME/CFS, associated prejudice and ignorance about the disease, and the lack of a standard case definition has stifled progress.”

Lines 192-194:

“Potential conflicts of interest among investigators need to be properly vetted, discussed, and addressed by all stakeholders.” 

IiME comment: 

This is of paramount importance. In the UK the example of the appalling complicity of the MRC in allowing vested interests to be involved in ME research must be a thing of the past.

Lines 202 -208:

“1. Define disease parameters. Assemble a team of stakeholders (e.g., patients, clinicians, researchers, federal agencies) to reach consensus on the definition and parameters of ME/CFS. A national and international research network should be developed to clarify the case definition and to advance the field. There are tremendous opportunities on which we have not yet capitalized to learn across disciplines and from other diseases such as Gulf War Syndrome, Lyme disease, fibromyalgia, multiple sclerosis, and Parkinson’s disease, to determine commonalities and differences.” 

IiME comment: 

There have been years of meetings and working groups (CFS Advisory committee has submitted recommendations several times) and so-called expert panels and this report should not lead to yet another committee with no real action, and no power. 

ME/CFS patients need research into their disease and researchers need substantially more funding to be able to do meaningful research in a progressive manner. 

Invest in ME have been facilitating international networking for nine years and it is starting to pay off but funding is needed to keep the networking going. 

In 2012 we held the first ME/CFS Clinical Autoimmune Working Group meeting in London, UK, in collaboration with The Alison Hunter Memorial Foundation (AHMF) of Australia and that colloquium included researchers from other disciplines such as MS, Rheumatology and oncology [12]. This was a real example of international collaboration and networking – organised by patients and carers. The consensus from that meeting was that the rituximab trial by Fluge et al. in Norway provided the best leads for future research [13]. 

In 2013 our 3rd colloquium resulted in Invest in ME setting up a project to conduct a UK rituximab clinical trial to allow collaboration and sharing of experiences with the Norwegian researchers, and others. 

In 2014 our 4th Biomedical Research into ME Colloquium had almost 50 biomedical researchers from nine countries involved and many new initiatives were created. Invest in ME are now organising our fifth colloquium – a two day affair. 

These are biomedical research meetings – aligned with our biomedical research conferences. We have a basis for international research and networking – it doesn’t need to be reinvented and it doesn’t need to be described as though it is a new idea.
So action is needed not merely words. (See our Conclusion later in the document.)

Lines 271-276:

“Patients often choose clinical trials or complementary and alternative medicine because effective treatment is not available and because traditional health care is not meeting their needs. Studies investigating homeopathy, non-pharmacologic, complementary, and alternative medicine treatments are needed. Studies addressing biopsychosocial parameters (including the mind-body connection), function, and QOL should be encouraged.” 

IiME comment: 

It is quite odd to see recommendations like this within the context of your previous comments of ME/CFS not being of psychological aetiology, lacking in basic research or patients experiencing stigma from the diagnosis, including social isolation and judgement (Lines 121-122). 

Encouraging studies into homeopathy, alternative treatments or mind-body connections at the same time as declaring lack of basic research would only add to this stigma – or prejudice. There is no more need for such studies in ME/CFS than there is for cancer, MS or Parkinson’s disease for example. Scarce research funding for ME/CFS should not be used for yet more trivialities. 

The Fluge et al. rituximab research did not fit your criteria of at least 12 week duration but it has captured the interest of renowned researchers outside the field such as Invest in ME’s advisor, Professor Jonathan Edwards, who was instrumental in getting rituximab accepted as treatment for rheumatoid arthritis. If that research can identify differences between responders and non- responders then that in itself would help move the field forward considerably. ME/CFS patients are keen on taking part in clinical trials such as rituximab or Ampligen as that is their only chance of getting ‘real’ treatment, of being taken seriously, of being treated with respect. 

What is meant here by the term biopsychosocial? If it is the same paradigm that has been promoted in the UK and rest of Europe since 2005 then we can inform you that it has not worked and patients deserve better than this [14]. 

We have written before that “….we feel it is impossible to marry the views of those who believe in the deconditioning/behavioural and wrong illness belief model of ME with those from the biomedical side. The failed PACE Trial has demonstrably proven that the behavioural view of ME cannot deliver and should not continue to command more funding.” [15] 

To include ME/CFS in a broad collaborative umbrella of other fatigue will do nothing, and produce nothing but delay in treating ME/CFS seriously. A mirage of progress which will waste another few years, forcing patients down a path of complicity by trust – a tried and trusted technique used in the UK to appear to do something but in essence achieve nothing. 

Incorporating the biopsychosocial model into any future strategy of ME/CFS research is asking patients to participate in one of the worst possible examples of Stockholm syndrome one can imagine. As can be seen we feel very strongly about this topic. 

We wonder why another agenda seems to be creeping into this document - when the fine and correct words earlier in the document seemed to be moving things in the right direction.

Lines 288-291:

“Although ME/CFS is not a psychiatric disease, exploring psychiatric comorbidities such as depression, anxiety, and fear is critical to improve quality of life. Response burden must be considered; a battery of simplified measures is strongly encouraged, as well as the triangulation of qualitative and quantitative data.” 

IiME comment: 

From our experience doctors that have no expertise in ME/CFS may confuse mood disorders, burn out, overtraining syndrome or excessive tiredness caused by another illness with ME/CFS so it is extremely important to train doctors to be able to diagnose ME/CFS and know the difference between ME/CFS and depression, for example, as well as being aware of the rate of misdiagnosis. Newton et al. research from 2010 showed that 40% of the patients referred to a specialist CFS clinic in the UK turned out to have an alternative diagnosis after careful examination. “Of the 40% of patients subsequently found not to have CFS the most common diagnosis was fatigue associated with a chronic disease (47% of all alternative diagnoses); 20% had primary sleep disorders, 15% psychological/psychiatric illnesses and 4% a cardiovascular disorder. Thirteen per cent remained unexplained (5.2% of the total referrals).” [16]. 

Co morbidities could be lessened by making sure patients are being treated with respect from the first point of contact and onward – basic medical ethics.

Lines 348-351:

“The modest benefit from CBT should be studied as adjunct to other modalities of treatment such as self management. Future treatment studies should evaluate multimodal therapies. Comparative effectiveness research is also needed.” 

IiME comment: 

Again it is strange to see a recommendation for CBT or therapies that are mainly aimed at behavioural or psychiatric illnesses when you have made it clear that ME/CFS is neither psychiatric nor psychological in aetiology. 

Most patients feel that CBT and self-management have been given more than enough attention already and it is time to explore other treatments along the lines of rituximab, gamma globulin, Ampligen, LDN etc. Self-management can be easily explained in a leaflet and patients support one another on online forums or support groups so resources should be directed toward well designed clinical trials that are based on well thought out hypotheses. 

What ME/CFS is lacking is input from various medical experts such as neurologists, immunologists, infectious disease specialists and endocrinologists and pain specialists that can explain the biology of the illness. 

You mentioned (lines 38-39, 365-366) that the Oxford criteria are flawed and should be retired. Should you then not remove any research that used those criteria from this review? 

What is meant by multimodal therapies? Is there any evidence that such therapies work for ME/CFS? It is of little wonder that patients suspect there is still a hidden agenda still being set out. 

The lines above are inconsistent.

Line 351-352:

“We recommend that the NIH and the FDA convene a meeting on the state of ME/CFS treatment.” 

IiME comment: 

Haven’t there been such meetings already? How many more do you need? 

There is a list of meetings on the FDA website, the latest one having been held in March 2014 [17]. The document from March 2014 states that regarding the number of drug trials needed to prove efficacy of symptom relief is two independent trials. Why is it then that this draft document is recommending even more CBT/GET/self- management trials when these therapies have already been tested a number of times without any objective measurable improvement [9, 10]? 

The UK PACE trial that formed part of your evaluation, despite using the Oxford criteria, was meant to be a definitive trial but it turned out to be so unsuccessful that even the entry criteria and recovery had to be altered to make it seem as value for the enormous £5million expense which was wasted on it [18, 19].

Lines 364-368:

“Specifically, continuing to use the Oxford definition may impair progress and cause harm. Thus, for needed progress to occur we recommend (1) that the Oxford definition be retired, (2) that the ME/CFS community agree on a single case definition (even if it is not perfect), and (3) that patients, clinicians, and researchers agree on a definition for meaningful recovery.” 

Invest in ME comment: 

This we can entirely agree with – something we have stated for many years - and it is good to see it in print. We need a medical speciality and centres of excellence that take responsibility of ME/CFS. For any specific treatment to have a chance to be successful patients need to be carefully phenotyped and it may be that there needs to be an emphasis on personalised medicine rather than trying to find something that fits all patients diagnosed with ME/CFS.

In Conclusion

Thank you for allowing us to submit our comments and we hope our views are taken on board as this affects not only US citizens but everyone diagnosed with ME or CFS across the world. Whilst it was good to see an outside group of experts trying to get an overview of ME/CFS research it is clearly not possible to do this successfully by just using a scoring method that works for a well-established disease that everyone agrees upon without any knowledge of the underlying history. It does not help that research into ME/CFS has two opposite viewpoints and this document consequently tries to facilitate both.

This is a major mistake and is contrary to any common sense.

It is illogical to do this and if the statement is made that ME/CFS is a physical disease then recommendations should follow logically from that statement. If there are co-morbidities they should be dealt with in the same way as one would do with co-morbidities in MS, cancer or Parkinson’s disease or any other disease.

We also found it difficult to comprehend what the real objective of this workshop was and we sincerely hope that this is not yet another paper exercise to keep the patient community seemingly happy whilst the authorities do nothing concrete to remedy the current situation.

It would be well for the NIH NOT to follow the UK example and repeat the mistakes and failures of the last generation where an insincere effort to change is portrayed as real progress but just results in wasted years. The mediocrity in terms of provision of correct and up to date definitions and guidelines, scientific research and development of treatments and perception of ME is a direct result, and failure, of the policies of the past.

The first part of this report started well describing the situation and what needs to be done. However, it begins to fall apart with instances where inexplicable references to bringing in components which have contributed to the abysmal situation in which ME/CFS patients find themselves. Whether intentional or actual, or not, It suggests that another agenda may be at play here.

We believe future research into ME must be based on collaboration. But it would seem quite meaningless to base the strategy on those failed policies and directions of the past - which have served patients so poorly and caused such suffering [20].

Research into ME needs a strategic approach - but it may be destined to fail completely by attempting to establish the way forward on foundations which include so much of what has been wrong in the past.

If we are seriously to have a way forward for proper research into ME then we need not just funding, but correctly defined cohorts, standardisation on diagnostic criteria and a collaborative of researchers who will not blur science with politics.

The NIH have a unique possibility to be bold, to fix this problem once and for all.

We therefore suggest the following –

We suggest that the NIH finally and totally abandon all links to the biopsychosocial model with regard to ME research funding.

We also suggest that instead of relying on alternative funding streams elsewhere that the NIH take responsibility themselves for ME/CFS. We suggest that the NIH invest $50 million per year for the next five years in biomedical research into ME/CFS, and provide correct and current education into the disease which will, in turn, raise appropriate awareness.

This would mean an investment of $250 million over 5 years. This amount will still be less than the documented annual cost of ME/CFS of $1 billion as noted in line 6.

This will create scores of biomedical research projects, lots of potential international collaboration, new ideas and new skills to enter the ME/CFS research area.

This will facilitate the harnessing of the full potential of academic and research institutes.

This will attract new, young researchers into the field of ME/CFS – this the charity has proven already with our BCell/rituximab project with UCL where a young researcher is drawn into this exciting area of research [21]

It will galvanise science and eventually form pockets of expertise which will create the centres of excellence for the future.

We suggest trying this for a 5 year period.

A yearly review of progress can inform every one of the status.

After 5 years of such funding a new conference/workshop/committee can be convened and progress can be examined.

This will provide the best chance possible for resolving this illness to the benefit of patients.

Our guess is that so much progress will have been made in research, in perception and possibly in treatments during that period that the money will be recouped with the added benefit of giving some people their lives back.

The stigma mentioned above – which is actually, in our opinion, just ignorant prejudice created by corrupt organisations and individuals, would be swept away.

$50 million per year is really not much.

After 5 years it will probably have so much momentum that it could carry on by itself through savings in welfare, through new discoveries and, yes, through private donations/funding

To begin this we invite NIH to be represented at our fifth Biomedical Research into ME Colloquium in London on 27-28th May 2015.

The charity will shortly announce the agenda – which will include most of the necessary areas to be looked at as well as the major research initiatives underway or planned.

We invite the NIH to be represented there in London – in order to join our international collaboration effort to resolve this illness in a way that brings hope to patients, brings responsible and proper science to the research area and brings a raising of awareness that will obliterate the monstrous distortions about ME/CFS which have poisoned all chance of making progress in the last generation.

What needs to be emphasised to all – something that is rarely acknowledged and which we see ignored by almost every organisation – is the urgency of the need for action and change.

This is urgent, lives are dependent on it – Treat it as being urgent!

• To make progress we need not mere words and a slow undeliberate action plan.
• Progress is a fine word – but change is its motivator
• To progress this illness we need to make a bold changes.

Invest in ME is a small charity with a BIG cause.

If such a small charity and its supporters can organise ten international conferences with delegates from 20 countries, if it can organise 5 biomedical research colloquiums attracting participants from top research organisations in a dozen countries, if it can initiate possibly the two most important research projects for ME in the UK (22) then the NIH should be able to do far, far better – and in a far shorter period of time.

In the words of the charity’s advisor Dr Ian Gibson: “Things do not have to be the way they are – we can change things.”

Let’s Do Change.

Let’s Do (biomedical) Research.

Let’s Do It For ME.

References:

1. https://prevention.nih.gov/programs-events/pathways-to-prevention/workshops/me-cfs

2. http://www.investinme.org/LDR%20UK%20Gut%20Microbiota.htm

3. http://www.ukrituximabtrial.org

4. Nacul LC, Lacerda EM, Pheby D, Campion P, Molokhia M, Fayyaz S, Leite JC, Poland F, Howe A, Drachler ML: Prevalence of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) in three regions of England: a repeated cross-sectional study in primary care.

5. BMC Med 2011, 9:91.

6. Snell CR, Stevens SR, Davenport TE, Van Ness JM. Discriminative validity of metabolic and workload measurements to identify individuals with chronic fatigue syndrome. Phys Ther.2013;93:1484–1492. doi: 10.2522/ptj.20110368

7. Vermeulen RC, Kurk RM, Visser FC, Sluiter W, Scholte HR. Patients with chronic fatigue syndrome performed worse than controls in a controlled repeated exercise study despite a normal oxidative phosphorylation capacity. J Transl Med. 2010;8:93. doi: 10.1186/1479-5876-8-93.Keller BA, Pryor JL, Giloteaux L. Inability of myalgic encephalomyelitis/chronic fatigue syndrome patients to reproduce VO2 peak indicates functional impairment. J Transl Med. 2014 Apr 23;12:104. doi: 10.1186/1479-5876-12-104.

8. White P D, Rickards H, Zeman A Z J. Time to end the distinction between mental and neurological illnesses BMJ 2012; 344:e3454

9. Sabine, Stordeur; Nancy, Thiry; Marijke, Eyssen (2008). Chronisch Vermoeidheidssyndroom: diagnose, behandeling en zorgorganisatie [Fatigue Syndrome: diagnosis, treatment and organisation of care] (Technical report) (in Dutch). KCE (Belgian Healthcare Knowledge Center). 88A

10. H. Knoop et al., “The effect of cognitive behaviour therapy for chronic fatigue syndrome on self-reported cognitive impairments and neuropsychological test performance,” J Neurol Neurosurg Psychiatry, vol. 78, no. 4, pp. 434–6 (2007).

11. Kindlon T. Reporting of Harms Associated with Graded Exercise Therapy and Cognitive Behavioural Therapy in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Bull IACFS/ME. 2011;19:59–111.

12. http://www.investinme.org/IIME%20Statement%202012-05-31.htm5

13. Fluge O, Bruland O, Risa K, Storstein A, Kristoffersen EK, Sapkota D, Næss H, Dahl O, Nyland H, Mella O. Benefit from B-lymphocyte depletion using the anti-CD20 antibody rituximab in chronic fatigue syndrome: a double-blind and placebo-controlled study. PLoS ONE.2011;6:e26358.

14. http://www.meactionuk.org.uk/PROOF_POSITIVE.htm

15. Tale of Two Collaboratives http://www.investinme.org/IIME-Newslet-1304-01.htm

16. Newton JL, Mabillard H, Scott A, Hoad A, Spickett G The Newcastle NHS Chronic Fatigue Service: not all fatigue is the same. J R Coll Physicians Edin 2010;40:304–7

17. http://www.fda.gov/Drugs/NewsEvents/ucm319188.htm

18. White, PD et al. Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. The Lancet , Volume 377 , Issue 9768 , 823 – 836.

19. http://www.pacetrial.org/

20. Diane’s Story – LILI http://www.investinme.org/mestory1010.htm

21. ME/CFS – Through The Eyes of a Young Researcher http://www.ukrituximabtrial.org/Rituximab%20newsJan15%2001.htm

22.http://www.investinme.org/IIME-Newslet-1410-01%20Possibly%20Most%20Important.htm

IACFS/ME Critiques P2P Draft Report, Insists on Increased Funding

ME/CFS is somewhere below that black line.

In a brief but hard-hitting letter to the P2P panel, the International Association for CFS/ME (IACFS/ME) has thrown down the gauntlet.

"To make significant progress," the letter said, "funding needs to be provided on par with that of other diseases that are similarly prevalent and disabling."

In order to do all the things the P2P panel has recommended in its Report, more funding is needed. But not only did the Draft Report fail to include amounts for future NIH research, it suggested funding avenues that were entirely inadequate for meeting current research needs.

The IACFS/ME letter also made a point of recommending that ME/CFS be moved from the Office for Research on Women’s Health (ORWH) to an Institute that actually has funds.

"We respectfully suggest either NINDS or NIAID as the primary Institute as multiple studies demonstrate that neurologic, infectious, and autoimmune components are present in this illness."

Nothing has been more detrimental to ME/CFS research grants than its current location under the auspices of ORWH. Back in the 1980s, when CFS was considered a contagious illness, it was represented by NIAID (National Institute of Allergy and Infectious Diseases). Funding, at that time, was devoted mainly to investigating viral etiology, but other biomedical research was pursued as well. Once CFS was moved to the ORWH, funding for serious biomedical research all but vanished.

The IACFS/ME's suggestion to house ME in the National Institute of Neurological Disorders and Stroke (NINDS), which has a budget of $1.5 billion, or NIAID, with its budget of over $4.4 billion makes perfect sense - provided that the NIH has more than a token interest in advancing research into the causes, mechanisms, and treatment of ME/CFS. 

____________________

Dear NIH P2P Panel Members,

As board members of the International Association for Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis (IACFS/ME), the largest international group of clinicians, researchers, and other professionals dedicated to the care and research of patients with ME/CFS, we hope that your report will have a positive influence on the field, our organization’s members, and the patients/ families we serve.

Generally we agree with the majority of the Panel’s recommendations but believe that the elephant in the room – research funding –  alluded to in the report (e.g. Line 8) needs to be addressed more strongly and specifically. Federal funding for ME/CFS research over the last 3 decades has been inadequate to the broad-ranging and complex challenges presented by this illness. In recent years, only $5-$6 million annually has been awarded on an extramural basis, resulting in ME/CFS being the least-funded out of 240+ conditions that NIH tracks annually.

(http://report.nih.gov/categorical_spending.aspx) Over the last 25 years that IACFS/ME has been in existence, we have seen few new researchers enter the field, a flat publication rate over the past decade, and continuing stigma surrounding the illness. 

This state of affairs is particularly concerning given the costs to society of this illness with respect to lost productivity and high health care costs. To whom do the one million US patients with ME/CFS turn to be reassured that their illness is being taken seriously with substantive commitments to scientific research?  Only the federal government, and NIH in particular, has the ability to make such commitments.

Many of the same recommendations and concerns highlighted by the Panel have been brought up by members of our organization over the years.  For example, last Spring, several of our board members who also served on DHHS’ CFS Advisory Committee suggested that NIH establish and support a data/ biobank-sharing platform and/or issue a Request for Applications focusing on specific areas to jumpstart research. Unfortunately, the recommendations were not accepted or acted upon by NIH. (http://www.hhs.gov/advcomcfs/recommendations/hhs-cfsac-recommendations-response.pdf)

The reasons given were that there were too few ME/CFS researchers to invest the funds for such a platform, that such funding would take away money from other ME/CFS projects, and that since so little was known about ME/CFS, a RFA was not the right mechanism for funding.  Interestingly, the letter then went on to state “RFAs are designed to build upon recommendations that have been identified……. [through] workshops and conferences” yet no RFA was issued for ME/CFS after NIH’s State-of-the-Knowledge Workshop on ME/CFS in 2011 despite the efforts of then-Trans-NIH-Working-Group head Dr. Dennis Mangan. The letter concludes by suggesting that mentored career development, student, and post-doctoral training grants be used.

(The last time NIH issued and RFA for ME/CFS, in 2007, a number of successful projects were funded.) (http://www.hhs.gov/advcomcfs/recommendations/06142014.html)

The essential message conveyed is that the US government does not want to invest additional funds because not enough is known about the disease and there are not enough researchers. Yet a critical  reason why we have a dearth of researchers and knowledge is because of the poor funding situation, which has endured for the past 3 decades. Lack of investment in basic research by the government also impacts other sources of ME/CFS research funding. In April of 2013, the US Food and Drug Administration hosted a Drug Development workshop for ME/CFS. The pharmaceutical representatives who attended cited poor understanding of the basic pathophysiology of ME/CFS as a major reason for the reluctance of their companies to invest in ME/CFS clinical research.

Finally, we believe it would be beneficial to change the institutional affiliation of ME/CFS from the Office for Research on Women’s Health (ORWH) to an Institute with research funds to distribute.  ME/CFS may have been placed under ORWH originally so that funding could be coordinated across institutes but that has not been successful. In fact, the Program Announcement for ME/CFS includes an October 2014 note that several Institutes – including NIA, NIDDK, NIEHS, and NCCAM – have withdrawn their participation. (http://grants.nih.gov/grants/guide/pa-files/PAR-12-032.html)   

Thus we encourage the NIH to consider assigning the management of CFS/ME research to a single NIH Institute and provide that Institute with the responsibility and appropriate funding to effectively manage the research effort in this disease. We respectfully suggest either NINDS or NIAID as the primary Institute as multiple studies demonstrate that neurologic, infectious, and autoimmune components are present in this illness. To make significant progress, funding needs to be provided on par with that of other diseases that are similarly prevalent and disabling. For example, multiple sclerosis and systemic lupus erythematosus are both funded at more than ten times the level ($112-$152 million and $92-$127 million annually respectively) of ME/CFS although ME/CFS, even using a conservative estimate, may be more common.

Thus we respectfully ask that the NIH Panel highlight the inadequate research funding of ME/CFS and link this core premise to specific recommendations for new funding initiatives, with dollar amounts, mechanisms, and deadlines, to begin to address the current underfunded status of this illness.

We also agree with the Panel’s suggestion that carefully constructed and operationalized case definitions are needed for research but disagree that the main issue is lack of agreement on a single research case definition. A single case definition, the 1994 Fukuda case definition, has been used for the majority of the studies worldwide.  However, there are concerns that Fukuda is neither sensitive nor specific enough to capture the patient population it is meant to capture; furthermore, it has not been updated in 20 years to reflect clinician/ patient experience, substantial new evidence from more recent studies on symptom frequencies, and newer case definitions in ME/CFS.

Thus, we ask that the Panel instead emphasize that any research case definition used be based on clinician/ patient experience and the scientific literature, be operationalized well enough that it is easily duplicated across studies by different researchers, and that it be validated and reassessed in a timely manner.

Thank you for this opportunity to comment on the Draft Executive Summary.  We hope that you will take our suggestions into account and will feel no hesitation in contacting us if we can be of further service.

Sincerely,

Fred Friedberg, Ph.D.                                                                               
President, IACFS/ME

Staci R Stevens, M.A.
Founder: Workwell Foundation; Ripon, CA
Co-Vice President, IACFS/ME

Rosamund Vallings, MNZM, MBBS
Howick Health and Medical Center; Auckland, New Zealand
Secretary, IACFS/ME

Julia Newton, MD, PhD
Dean of Clinical Medicine & Professor of Ageing and Medicine
Clinical Academic Office, The Medical School, Newcastle University; New Castle upon Tyne,
United Kingdom
Board member, IACFS/ME

Jon D. Kaiser, MD
Clinical Faculty, Dept. of Medicine, UCSF Medical School; San Francisco, CA
Medical Director, K-PAX Pharmaceuticals, Inc.
Board Member, IACFS/ME

Steven P. Krafchick MPH, JD
Krafchick Law Firm PLLC, Legal Services for Injured and Disabled People; Seattle, WA
Board member, IACFS/ME

When Bureaucrats Smile: The perpetuation of the status quo by HHS -Jerrold Spinhirne's commentary

The Bureaucrats of Medicine, by Jose Perez

Thomas Sowell has been quoted as saying, “You will never understand bureaucracies until you understand that for bureaucrats procedure is everything and outcomes are nothing.”  Nowhere is this more evident that in the P2P Workshop, where process replaced evidence at every turn,

Jerrold Spinhirne, with his usual thoroughness, has pointed out the weaknesses in HHS's manner of approaching "the ME/CFS question."

The deadline for submitting comments to the P2P about their Draft Report is today. These comments will not become part of the public record. Comments can be submitted via email to: prevention@mail.nih.gov. 

Please reference the corresponding line number of the report. 

If you submit a comment, please send a copy to Jenny Spotila for inclusion in her library of comments at jspotila AT yahoo DOT com. You can read public comments on her blog, Occupy CFS.

Related post: The P2P Draft Report: Pros and Cons - and My Public Comment

____________________

My Public Comment for the January 13, 2015 CFSAC Meeting

 By Jerrold Spinhirne  January 4 2015

The utter folly of choosing inexperienced non-experts outside the field to write about a contested disease is shown in the opening statement of the 2014 Pathways to Prevention Workshop (P2P) on "Myalgic Encephalomyelitis/Chronic Fatigue Syndrome" Draft Executive Summary:

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a chronic, complex,
multi-faceted condition characterized by extreme fatigue and other symptoms that are
not improved by rest. The etiology and pathogenesis remain unknown; there are no
laboratory diagnostic tests; and there are no known cures.

In the first place, it is entirely unclear what the P2P draft report is about.

It purports to be about a condition "characterized by extreme fatigue."However, the neurological disease myalgic encephalomyelitis (ME) is NOT characterized by extreme fatigue.

Unexplained fatigue is the characteristic feature of chronic fatigue syndrome (CFS), not myalgic encephalomyelitis (ME).

Classic descriptions of the neurological disease ME [Acheson, 1959; Ramsay, 1986] and the 2011 ME International Consensus Criteria [Carruthers, 2011] do NOT list fatigue as a diagnostic symptom of the disease – let alone as a characteristic feature of the disease.

Therefore, the P2P draft report cannot be about ME. However, the novice authors of the report seem to be unaware this fact and wish to include ME as a part of the undefined condition they are referring to as "ME/CFS" that is "characterized by extreme fatigue."

This in the complete 1986 definition of myalgic encephalomyelitis by Dr. A. Melvin Ramsay written after 30 years of carefully observing the disease in hundreds of patients:       

A syndrome initiated by a virus infection, commonly in the form of a respiratory or gastrointestinal illness with significant headache, malaise and dizziness sometimes accompanied by lymphadenopathy or rash.

Insidious or more dramatic onsets following neurological, cardiac or endocrine disability are
also recognised. Characteristic features include:

       (1) A multisystem disease, primarily
       neurological with variable involvement of liver,
       cardiac and skeletal muscle, lymphoid and
       endocrine organs.

       (2) Neurological disturbance – an unpredictable
       state of central nervous system exhaustion
       following mental or physical exertion which
       may be delayed and require several days for
       recovery; an unique neuro-endocrine profile
       which differs from depression in that the
       hypothalamic/ pituitary/adrenal response to
       stress is deficient; dysfunction of the
       autonomic and sensory nervous systems;
       cognitive problems.

       (3) Musculo-skeletal dysfunction in a
       proportion  of patients (related to sensory
       disturbance or to the late metabolic and auto
       immune effects of infection).

       (4) A characteristically chronic relapsing
       course.[Ramsay, 1986]   

Where's the "extreme fatigue" that the inexperienced P2P authors claim characterizes "ME/CFS"?

It should be clear that whatever "ME/CFS" is in the P2P draft report, it is not ME.

Consistent with Ramsay's classic definition of ME, the 26 highly qualified and experienced professionals who developed the 2011 International Consensus Criteria document, published in the Journal of Internal Medicine, also do NOT include fatigue in the name of the disease or as a criterion for making an ME diagnosis.

They state:       

Using ‘fatigue’ as a name of a disease gives it exclusive emphasis and has been the most confusing and misused criterion.

No other fatiguing disease has ‘chronic fatigue’ attached to its name – e.g. cancer/chronic fatigue, multiple sclerosis/chronic fatigue – except ME/CFS.
Fatigue in other conditions is usually proportional to effort or duration with a quick
recovery and will recur to the same extent with the same effort or duration that same or next day.

The pathological low threshold of fatigability of ME described in the following criteria often
occurs with minimal physical or mental exertion and with reduced ability to undertake the same activity within the same or several days. 

The ICC document states: ME is characterized by an abnormal biological response to exertion or exercise that is objectively measurable by the 2-day cardiopulmonary exercise test (CPET). [Carruthers, 2011; VanNess, 2007]

According to the ICC:

"Pain and fatigue are crucial bioalarm signals that instruct patients to modify what they are doing in order to protect the body and prevent further damage."

The fatigue experienced by ME patients is the result of an underlying disease process and cannot be considered as medically unexplained any more than can be the fatigue experienced by cancer and MS patients.

Why then would the P2P draft report authors include the "ME" part of the term "ME/CFS" that is used apparently to refer to some condition other than ME?

The only reason can be because bureaucrats at the Department of Health and Human Services (HHS) told the compliant members of the "unbiased, independent" P2P panel to use the term "ME/CFS" throughout their report and never mind what it means.

The only published case definition using the term "ME/CFS" is the 2003 Canadian Consensus Criteria (CCC) document [Carruthers, 2003], but confusingly the P2P draft report uses "ME/CFS" in a broader sense to refer to some nebulous fatigue condition that is never delineated.

The hybrid term "ME/CFS" explicitly embodies what has been the major problem in the field ever since the CDC dispatched two inexperienced, unqualified investigators to the Lake Tahoe region of Nevada in the fall of 1985 in response to one of the many outbreaks of ME in the 20th century – the conflation of the neurological disease ME with a poorly described socially constructed syndrome based almost entirely on the undefinable, unmeasurable symptom of perceived fatigue.

For 26 years after the CDC mischaracterized ME as a fatigue syndrome in 1988, [Holmes, 1988] all patients with ME in the US have been misdiagnosed as part of the CDC's overly broad chronic fatigue syndrome collection of self-reported symptoms.

Simply tacking the term "ME" on to "CFS" using a slash does absolutely nothing to correct this problem.

In fact, using "ME/CFS" makes the problem much worse.

How can the neurological disease ME ever be separated from the fatigue condition CFS if the two disparate terms are combined in a single term?

Of course they can't be separated.

This is why HHS now favors the unclassifiable, undefined term "ME/CFS" and has instructed their "unbiased, independent" P2P panel to use "ME/CFS" exclusively in their report to refer to who knows what.

If any of the P2P draft report authors has ever attempted to diagnose a patient with "ME/CFS" and consulted the current US ICD-9-CM, used to code diagnoses for billing and reporting purposes, they would find that the hybrid term "ME/CFS" is not listed.

Only the diagnostic term "chronic fatigue syndrome" is listed as 780.71 under "Symptoms, Signs, And Ill-Defined Conditions."

"ME/CFS" also has never been listed in the World Health Organization's International Classification of Diseases (ICD).

ME, however, has been listed in the WHO ICD as a neurological disease since 1969.

Indeed, the hybrid "ME/CFS" diagnostic term can never be legitimately listed in the WHO ICD. It's an unclassifiable chimera that violates the WHO rule of only using mutually exclusive diagnostic terms that fall within a single category.

Nor will the hybrid term "ME/CFS" be listed in the upcoming US ICD-10-CM, official October 1, 2015.

Only the diagnostic terms "chronic fatigue syndrome" in the general symptoms section and "benign myalgic encephalomyelitis" in the neurological diseases section will be listed.

How then will a doctor code an "ME/CFS" diagnosis?

Because doctors in the US have only been informed about CFS, if informed at all, and know nothing of ME, "ME/CFS" will be coded as the ill-defined condition CFS and not as the neurological disease ME.

This fact renders HHS's current use of the term "ME/CFS" hypocritical and nonsensical.

How then is one to interpret such statements in the P2P draft report as:

"Patients experience stigma from the diagnosis of ME/CFS, including social isolation and judgment"?

How can patients experience stigma from a diagnosis of "ME/CFS" when CFS is the diagnostic term now used by doctors in the US? 

The draft report is retrospectively calling CFS "ME/CFS."

This muddled historical revisionism is the result of the "unbiased, independent" P2P panel allowing itself to be misguided by HHS bureaucrats.

Despite obviously not knowing what "ME/CFS" might be, the P2P draft report authors on page 3 make the breathtaking leap of faith to assure readers that "ME/CFS exists."

This is bit like declaring Bigfoot exists despite being unable to come up with a clear description of the creature.

However, the confusion of the authors is understandable because their newly acquired knowledge of "ME/CFS" is largely based on a recent Agency for Healthcare Research and Quality (AHRQ) Evidence Report No. 219:

"Diagnosis and Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome" [Smith, 2014] also written by "unbiased, independent" neophytes in the field.

The Executive Summary of the AHRQ Final Evidence Report on page ES-1 makes the egregious misstatement that of the eight published case definitions considered:

"All include persistent fatigue not attributable to a known underlying medical condition, as well as additional clinical signs and symptoms."

Evidently, the "unbiased, independent" authors of the AHRQ report Executive Summary in their eagerness to make "ME/CFS" all about "persistent fatigue" failed to note that several pages later, the main report states:

"All but one of the definitions include persistent fatigue not attributable to a known underlying medical condition, as well as additional clinical signs and symptoms that do not all need to be present to establish the diagnosis." [Smith, 2014, page 2, italics added]

Table 2 on page 14 of the AHRQ Evidence Report clearly shows that the one exception that does not use the criterion of fatigue in its case definition is the "International ME Carruthers 2011" case definition in the fourth column from the left. [Carruthers, 2011]

This omission is vitally important because the neurological disease ME is not a fatigue syndrome, nor a part of any fatigue syndrome.

Nevertheless, HHS and their Centers for Disease Control (CDC) have failed to recognize the disease and to list ME as an exclusionary diagnosis for inclusion in the CDC's broad chronic fatigue syndrome umbrella diagnostic category.

It can be argued, supported by extensive research, that ME itself is a "known underlying medical condition" to which any fatigue reported by a patient can be attributed. Therefore, ME cannot be considered part of any condition characterized be unexplained fatigue – including ironically HHS's new undefined "ME/CFS" fatigue illness blend.

It has been the long-standing policy of HHS to support the misdiagnosis of ME patients with CFS – a policy that spares the private insurance industry the cost of appropriately medically testing for and treating ME

Keeping ME concealed within CFS, and now "ME/CFS," also spares the Department of Health and Human Services the expense of appropriately funding biomedical research on a major neurological disease..

Instead, HHS now gets away with only spending a pittance each year on often social science research of an elusive fatigue condition called CFS.

HHS wishes to avoid at all costs acknowledging their concealment of ME for decades within CFS.

Apparently the "unbiased, independent" P2P report authors are happy to oblige HHS by failing to read any further than the Executive Summary of the AHRQ report and using HHS's new undefined, catch-all term "ME/CFS" without question.

The P2P authors naively misrepresent ME in their draft report as a part of a dazzling "complex, multi-faceted condition characterized by extreme fatigue" completely oblivious to the history of ME in the medical literature and its current 2011 ICC case definition.

Anyone familiar with the field would have noticed the glaring error on page ES-1 of the AHRQ Evidence Review and pointed it out rather than repeating it.

If the P2P draft report authors had read the 2012 ME International Consensus Primer (IC Primer or ICP) [Carruthers. 2012], they would know better than to parrot the CDC's popular myth that "there are no laboratory diagnostic tests" for the disease.

The IC Primer already lists over 30 laboratory tests and imaging studies specifically useful in diagnosing ME, in addition to standard laboratory screening tests.

Despite the P2P draft report's familiar call that more research is needed, it is completely unclear just what it is that needs to be researched.

Research on any actual disease has been hampered for decades by use of the overly broad 1994 Fukuda CFS case definition. [Fukuda, 1994]

Fukuda CFS research results cannot be applied to any specific patient group or consistently replicated.

The P2P draft report completely fails to address the total lack of funding by the National Institutes of Health (NIH) for any research on the neurological disease ME with subjects selected using specific ME criteria.

As the IC Primer states:"There is a current, urgent need for ME research using patients who actually have ME." This urgent need is completely ignored by the authors of the P2P draft report who were charged with identifying "research gaps and future research priorities."

The P2P draft report calls for the 1991 Oxford CFS definition to be "retired."

No mention is made, however, of retiring the CDC's 1994 CFS Fukuda definition which has also been impairing progress in the field for over 20 years.

Does "retiring" the Oxford definition mean the CDC will remove the 2011 PACE trial, which used the Oxford definition, as a reference in their CFS continuing medical education course?

The CDC has used the Oxford-based PACE trial to support their irresponsible recommendation of using exercise as "therapy" to treat CFS. 

In fact, "retiring" the Oxford definition means very little in actual practice because Oxford has never been used in NIH-funded CFS research..

Will the invalid UK PACE trial be retracted based on the P2P panel's recommendation?

It won't be.

No doubt, the CDC will continue to use Oxford-based research as a reference whenever it supports the CDC's agenda of recommending primarily behavioral treatments for their chronic fatigue syndrome.

Unbelievably, to remedy the current chaos caused the use of multiple case definitions, the P2P draft report authors want to "assemble a team of stakeholders (e.g., patients, clinicians, researchers, federal agencies) to reach consensus on the definition and parameters of ME/CFS."

Apparently, the draft report authors are unaware that a consensus of truly independent, expert professionals in the field was reached over 10 years ago in the 2003 Canadian Consensus Criteria (CCC) and updated in 2011 by the International Consensus Criteria (ICC).

The ICC has now been used to select subjects with ME for research studies indicating widespread neuroinflammation and immune system abnormalities are associated with the disease. [Nakatomi, 2014; Brenu, 2013]

However, when then HHS Secretary Kathleen Sebelius was offered the
opportunity in 2013 of adopting the compromise CCC case definition, as
recommended by 50 expert professionals in the field, she summarily rejected the proposal.

Instead, HHS is now pursuing a new unneeded redefinition of "ME/CFS" using a contracted Institute of Medicine panel composed mostly of the controllable "unbiased, independent" non-experts favored by HHS bureaucrats. 

Nevertheless, the unknowledgeable P2P panel is calling for yet another grand consensus by a "team of stakeholders" and a pie-in-the-sky "national and international research network."

It should be clear to anyone that the problem is bad faith at HHS – not the
lack of existing excellent consensus diagnostic and treatment guidelines
that can also be used for research.

The diagnostic and research criteria for other major diseases are developed by expert professionals in the field and their organizations, without inference from government bureaucrats and agencies.

The harm caused by governmental meddling with disease criteria is demonstrated by the unscientific 1994 Fukuda CFS criteria controlled and developed primarily by NIH and CDC bureaucrats with major input from UK psychiatrists.

These bureaucrats had personal and institutional agendas which they placed above the public interest. [Straus, undated] For two decades, the overly broad
Fukuda CFS criteria have confounded research and led to the medical neglect and mistreatment of patients.

ME expert Dr. Byron Hyde wisely observed in a paper presented in New South Wales in 1998:

Definitions are not diseases, they are often simply the best descriptions that physicians
and researchers can offer, with their always imperfect knowledge, to describe a disease.

Good definitions are good because they correspond closely to the disease state being
described.

It is thus important that those that attempt to define any disease or illness to have long term clinical experience with patients with this illness.

       There is simply no place for the bureaucrat in defining illness. .

All definition of epidemic or infectious illness must be based upon persistent clinical
examination of the afflicted patient, an understanding and exploration of the
environmental factors producing that illness,and pathophysiological examination of tissue
from those patients.

For similar reasons, I believe that the inclusion of psychiatrists in the defining of an 
epidemic and obviously disease of infectious origin simply muddies the water for any serious understanding of that disease. [Hyde, 1998. Emphasis added]

Yet the naive P2P panel is calling for still more governmental interference in medical science by wanting "federal agencies" to be included in choosing yet another set of criteria for a fatigue condition now called "ME/CFS."

When will professionals realize the harm caused by governmental interference with science and refuse to take part in such efforts?

Currently, the only two contemporary case definitions that reflect the physical reality of the disease were developed by professionals in the field with a minimum of governmental interference – the 2003 CCC and 2011 ICC.

The unknowledgeable P2P panel from outside the field seems to be unaware that most of the problems the panel has "discovered" have already been addressed by the 2011 ICC and 2012 IC Primer.

HHS can begin correcting these problems by recognizing ME as the distinct neurological disease that it is and removing ME from the broader inappropriate CFS category, as called for by the ICC.

HHS needs to assume an ancillary role and begin disseminating the IC Primer to doctors so they can make the differential diagnosis of ME, instead of continuing to place ME patients at risk by misdiagnosing them with CFS or some new "ME/CFS" pseudo-diagnosis.

The tools for educating medical professionals about ME already exists in the ICC and IC Primer.

The problem is HHS does not want to devote the necessary resources to educating doctors and healthcare professionals on how to recognize, diagnose, and properly treat ME.

HHS prefers, instead, to accept the increased disability in the US population and increased yearly cost to the economy caused by medically neglecting and mistreating ME.

The HHS leadership has chosen to support the bureaucrats at the CDC's inept CFS program, and their negligent CFS Toolkit collection of dangerous medical misinformation, over the public interest. [CDC, undated]

Why would HHS ever implement any of the grand proposals of the P2P draft report when HHS stubbornly refuses to take even the low-cost, simple step of removing the harmful, inaccurate CFS Toolkit from the CDC website and disseminating the urgently needed IC Primer to healthcare professionals?

Doctors now are unaware of the possible permanent harm to their ME patients posed by exercise and overexertion.

ME must be recognized and diagnosed early so the patient can be advised to take total rest to limit the risk of permanent severe disability caused by the disease.

Pioneer ME doctor A. Melvin Ramsay has noted:

The clinical picture of myalgic encephalomyelitis has much in common with that of multiple sclerosis but, unlike the latter, the disease is not progressive and the prognosis should therefore be relatively good.

However, this is largely dependent on the management of the patient in the early stages of the illness. Those who are given complete rest from the onset do well... [Emphasis added]

Doctors have been left totally uninformed about ME by the continued misconduct of HHS bureaucrats.

Instead of conducting seminars educating doctors about ME with information that is now readily available, HHS is squandering public money on the obfuscating P2P Workshop and its report which will soon be forgotten.

The leadership at HHS has chosen to place their highest priority on protecting the mistakes of their bureaucrats and the profits of the insurance industry, rather than protecting the public health.

The primary consideration of "unbiased, independent" P2P draft report is obviously pleasing the HHS bureaucrats who commissioned the report, rather than adding any clarity to the muddled mess created by those very bureaucrats.

Any useful suggestions made in the final P2P report will simply be ignored by HHS bureaucrats as they have done for decades.

The P2P draft report can hardly be expected to address the main problem currently forestalling any hope of progress in researching, diagnosing, and treating ME – the refusal of HHS to listen to the truly independent, knowledgeable medical and scientific professionals in the field.

Instead, HHS continues to enlist controllable non-experts to add more confusion and delay to the field. The P2P draft report itself is a prime example.

References:

Acheson, ED. The clinical syndrome variously called benign myalgic encephalomyelitis, Iceland disease and epidemic neuromyasthenia. Am J Med 1959; 26(4):569–595. (http://bit.ly/ZfQM6Z)

Brenu EW, Johnston S et al. Immune abnormalities in patients meeting new diagnostic criteria for chronic fatigue syndrome/myalgic encephalomyelitis. J Mol Biomark Diagn 2013; 4:152. 

Carruthers BM, Jain AK et al. Myalgic encephalomyelitis/chronic Fatigue Syndrome: Clinical Working Case Definition, Diagnostic and Treatment Protocols. Protocols. J of Chronic Fatigue Syndr 2003; 11:7-154.

Carruthers BM, van de Sande MI et al. Myalgic encephalomyelitis: International Consensus Criteria. J Intern Med 2011; 270:327–38.

Carruthers BM, van de Sande MI et al. Myalgic Encephalomyelitis – Adult & Paediatric: International Consensus Primer for Medical Practitioners. Published online October 2012. (http://bit.ly/1xrlLdw)

Centers for Disease Control and Prevention. Chronic Fatigue Syndrome: A Toolkit for Providers. Undated. Accessed December 14, 2014. (http://1.usa.gov/1GZ3khv)

Fukuda K, Straus SE, Hickie I et al. Chronic fatigue syndrome: a comprehensive approach to its definition and study. Ann Intern Med 1994; 12:953–9.

Holmes GP, Kaplan JE, Gantz NM et al. Chronic fatigue syndrome: a working case definition. Ann Intern Med. 1988; 108:387-389.

Hyde BM. Paper presented in New South Wales, February 1998. (http://bit.ly/14pwCtQ)

Nakatomi Y, Mizuno K et al. Neuroinflammation in patients with chronic fatigue syndrome/myalgic
encephalomyelitis: An 11C-(R)-PK11195 PET study. J Nucl Med 2014; 55:1–6.

Ramsay AM. Myalgic Encephalomyelitis and Postviral Fatigue States: The saga of Royal Free disease. 1st ed. London: Gower Medical Publishing; 1986.

Smith MEB et al. Diagnosis and Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Evidence Report/Technology Assessment No. 219. (Prepared by the Pacific Northwest Evidence-based Practice Center under Contract No. 290-2012-00014-I.) AHRQ Publication No. 15-E001-EF. Rockville, MD: Agency for Healthcare Research and Quality; December 2014 (http://1.usa.gov/1ANVN2Y)

Straus, Stephen. Undated letter on NIH letterhead to Keiji Fukuda quoted and posted online by Craig
Maupin in The CFS Report,March 2014 post, CDC and NIH Officials Discussed "Desirable Outcome" of Seeing A Distinct Illness "Evaporate.” (http://bit.ly/OygptU)

VanNess JM, Snell CR, Stevens SR. Diminished cardiopulmonary capacity during post-exertional malaise. J Chronic Fatigue Syndr 2007; 14: 77-85.