Tuesday, 24 July 2018

Letter from Professor Malcolm Hooper to Bridget Phillipson MP

http://www.margaretwilliams.me/2018/hooper-to-phillipson.pdf

16th July 2018

Dear Bridget,

Many thanks for forwarding the letter of 14th June 2018 (PO-1133220) from Lord O’Shaughnessy, Parliamentary Under Secretary of State for Health (Lords) in response to my request for your support for Carol Monaghan MP’s presentation in Parliament about the medical scandal of the PACE trial involving ME/CFS patients.

I should be grateful if you would kindly forward this reply to Lord O’Shaughnessy himself please and inform him that I require his response to the issues I raise herein.

Carol Monaghan MP has done a great service for the whole ME community, including not only patients and carers, but also sympathetic and informed clinicians.

Finally the truth is now emerging about the PACE study and hence I found Lord O’Shaughnessy’s reply to be egregiously erroneous.

I feel sure that he did not write the letter himself, which I suspect was drafted by one of the many advocates of the PACE trial who are still trying to rescue something from the debacle of this now-infamous clinical trial.

Because the issue is of such immense national – and indeed international – public interest, I have addressed chronologically and in some detail the more glaring untruths contained in his letter.

By way of introduction, I bring to Lord O’Shaughnessy’s attention relevant extracts about the PACE trial from a Submission on ME on 29th June 2018 to the Scottish Parliament by Professor Jonathan Edwards, Emeritus Professor of Medicine at University College, London (PE1690/F):

“Service Provision Problems. ….A range of physical and psychological treatments including graded exercise therapy (and) cognitive behavioural therapy…based on theories of psychological perpetuation of the illness have been subjected to methodologically inadequate trials and have been introduced into mainstream healthcare based on uncritical interpretation of the results.

“Specific Weakness in Clinical Trial Methodology.  No trial of a drug using the methods used in these trials would be acceptable for drug approval…If you are not able to obtain reliable evidence you cannot obtain unreliable evidence and treat it as reliable….Both CBT and GET are based on the idea that the patient is not just encouraged to, but instructed to, take responsibility for taking on a frame of mind in which they see themselves as likely to improve.  That is to say that the treatment deliberately introduces subjective bias of exactly the sort that proper trial design is designed to avoid….The theory was that the persistence of disability in ME is due to unhelpful beliefs about inability to improve.  What PACE seems to show is that it may be possible to change patients’ beliefs…but crucially, the measure of disability did not change. This suggests that even if unhelpful thoughts were present, they were not the cause of the disability.  Moreover, the long-term follow up data from PACE show no difference from controls even in reported well-being in the CBT and GET groups. It is now documented from trial committee minutes that detailed assessment of activity with actometers was abandoned because a previous study had already suggested no improvement would be seen – which would not have supported the preferred hypothesis.

“Failure of Communication. It is reasonable to ask why these treatments have become routine practice despite the evidence base being valueless. These therapies have been promoted by a group of psychiatrists….but with other physicians largely unaware of what was going on until recently….The standard of assessment of evidence in psychological medicine appears to be well below other specialities.  There is also a troubling hint that it is convenient…for patients to be shunted into standardised therapy protocols rather than given meaningful long term support.  The patient community has been publicly vilified by the trial authors and colleagues but they have turned out to be right.  They have identified a serious weakness in the quality of both science and peer review in psychological medicine.

“Urgent Need to Address Legitimate Complaints. The witnesses made two reasonable complaints.  The first is that unproven treatments are being offered in place of meaningful care. The second is that these treatments cause distress and perhaps harm.  CBT is demeaning because the patient works out that it presumes that their sense of being unwell is an illusion. Since very few people recover, it also offers false hope.  GET makes no sense if the defining feature of ME is feeling ill after exertion….Patients report long-term deterioration after battling to achieve physical exercise goals…and the prima facie case is that they should be taken seriously. The appreciation in the last two or three years that CBT and GET have no sound evidence base leaves regional health services with difficult decisions….Specialist services are needed for an illness that very few doctors have practical knowledge of…It is likely that significant sums of money are being wasted on treatments that are distracting health care professionals from useful care and causing unnecessary distress.  The situation needs urgent review”.

It is indisputable that there are serious problems with Lord O’Shaughnessy’s DoH support for the PACE trial as set out in his letter.

In particular, I seek his clarification about the diametric difference between his Department’s support for the PACE trial as set out in his letter to you and his Department’s stance as set out in Hansard.

Lord O’Shaughnessy will be aware that the two key arms of the PACE trial (CBT and GET) were predicated on the biopsychosocial model of ME/CFS (ie. that there is no underlying pathology) and which categorised it as a mental (behavioural/somatoform) disorder from which “recovery” is possible following cognitive restructuring and increasing aerobic exercise, whereas the Government’s official policy is that ME/CFS is a neurological disorder from which recovery cannot be possible merely by changing a patient’s (correct) perception that s/he is suffering from a biomedical disorder.

On 30th January 2006 the then Health Minister, Lord Warner, said on the record: “There is only one World Health Organisation International Classification of Diseases code for chronic fatigue syndrome / myalgic encephalomyelitis, which is G93.3” (HL3612), G93.3 being neurological disorders.

On 2nd June 2008 Lord O’Shaughnessy’s predecessor, the Parliamentary Under Secretary of State, Department of Health (Lord Darzi of Denham) stated: “My Lords, the Government accept the World Health Organisation’s classification of CFS/ME as a neurological condition….My Lords, I have acknowledged that CFS/ME is a neurological condition” (HLPQ: Health: Chronic Fatigue Syndrome / Myalgic Encephalomyelitis).

On 21st November 2011 Lord Freud, Minister for Welfare Reform, confirmed in a letter to the Countess of Mar that the Department for Work and Pensions does not consider ME/CFS to be a mental disorder. The letter was unequivocal: “The Department of Health has indicated that they have ‘always relied on the definition set out by the World Health Organisation in its International Classification of diseases (ICD) under ICD code G93.3, subheading other disorders of the brain’.  The DWP is in agreement with this view.  Therefore, for the avoidance of doubt, I can be clear that the Department does not classify CFS/ME as a mental health disorder”.

By supporting the now-proven fraudulent PACE trial results that categorise ME/CFS as a behavioural disorder, Lord O’Shaughnessy is contradicting his own Department’s official policy.

The Department of Health and Social Care cannot pretend to be unaware that the PACE trial has now become a by-word for poor science in which data has been shamefully manipulated in an attempt (i) to achieve the pre-determined and promised outcome; (ii) to justify the cost of £5 million and (iii) to justify the extravagant claims made under the auspices of the Science Media Centre as part of its active campaign to discredit people with ME when the study was first reported in The Lancet in 2011.  Lord O’Shaughnessy may be aware of the close link between the psychiatrists involved in the PACE trial and the industry-funded Science Media Centre, one of whose founder members (Professor Sir Simon Wessely) directed the PACE trial statisticians in his role of overseeing the Clinical Trials Unit.  Lord O’Shaughnessy cannot be unaware that the SMC supports and publicly promotes in the media the PACE Investigators’ disproven beliefs about the nature of ME despite the fact that the PACE Investigators are acting in contravention of DoH policy.

I now address specific inaccuracies in Lord O’Shaughnessy’s letter:

1. The PACE trial…was funded by the MRC”: Lord O’Shaughnessy has been disingenuous when he implies that the PACE trial was funded by the MRC alone, the MRC being perceived by some less-informed individuals as demanding the highest scientific integrity (written evidence of the MRC’s collusion in the numerous breaches of protocol and of the MRC’s own code of practice is available if required).  He will surely be aware that the PACE trial is the only clinical trial co-funded by the DWP; this is known to be because the Chief Principal Investigator promised a reduction in State benefit claims by people with ME/CFS once the pre-determined PACE trial results were published. Other co-funders included the Scottish Chief Scientist’s Office and Lord O’Shaughnessy’s own Department of Health.

2. The trial provided evidence that both cognitive behavioural therapy (CBT) and GET were moderately effective…and were better than adaptive pacing therapy or SMC alone in improving both symptoms and disability”: this has been supported by over 100 international experts as being untrue.  From 2011 to 2016 there was a concerted attempt by all involved in the PACE trial to prevent the raw data from this publicly funded study being released (ie. by the Principal Investigators themselves, editors, publishers, funders and sponsors including the Department of Health, the Department for Work and Pensions, the Office of the Scottish Chief Scientist, the MRC and Queen Mary University of London). This is technically illegal since the Principal Investigators of such publicly funded research are required to make the obtained data available to bona fide interested scientists. As noted above by Professor Edwards, many of these scientists were repeatedly and publicly vilified and ridiculed by the PACE trial Investigators (and by their fellow supporters of the psychosocial model who, like the PIs, work for and are involved with the medical insurance industry) as being “vexatious” in making their requests.  Eventually after a FOIA request from a severely sick ME sufferer (which was resisted to the highest level of the tribunal), the data was finally released at a cost of £250,000 incurred by QMUL in its attempts not to release the actual data.  Analysis of the data by a range of experts, patients and scientists (including world-renowned statisticians) showed that the originally published data had been grossly and deliberately manipulated in an attempt to justify the desired conclusions. This is scientific fraud and has no place in the scientific and medical literature. The study was doomed to fail because of basic flaws in its design (Goldin R.  March 21st, 2016: http://www.stats.org/pace-research-sparked-patient-rebellion-challenged-medicine/). There were no objective measurements made to justify the claims of the work: only subjective and unblinded data was reported.  Having registered and published the trial protocol, in contravention of accepted scientific norms, the Principal Investigators abandoned the trial’s statistical analysis plan and changed the primary outcomes after the trial had finished and they did not publish their revised statistical analysis plan until after the primary results of the trial had been published in The Lancet.  Importantly, the PI’s new statistical analysis plan did not contain their new definition of “recovery”, when in fact the new definition of “recovery” was markedly less stringent than the definition in the original protocol and was devised after the PIs had seen the trial data, to which they were unblinded.  For the avoidance of doubt, I should be grateful if Lord O’Shaughnessy would be kind enough to ascertain the date of the meeting at which the PI’s new definition of “recovery” was agreed.  Crucially, it is important to note that the PI’s new definition of “recovery” specified a physical function threshold lower than that required to enter the trial ie. a participant’s physical function could deteriorate during the trial but the same participant would still meet the post-hoc definition of “recovery” so were classed and reported as “recovered”. Indeed, 13% of participants met the new “recovery” threshold at the start of the trial.  By any standards, this is indefensible. As noted by Professor Edwards, at long-term follow up there was no difference between the trial groups, so the favoured interventions of CBT and GET cannot be claimed to be even moderately effective as claimed by Lord O’Shaughnessy.  Many clinicians and medical scientists have recognised that the PACE trial has invalidated the use of CBT and GET in ME (for example, Vink M. Journal of Neurology & Neurobiology 10 January 2017:3:1).   The US National Institutes of Health, one of the world’s foremost medical research centres, convened a Pathways to Prevention working group which in December 2014 published its draft Statement entitled “Advancing the Research on Myalgic Encephalomyelitis / Chronic Fatigue Syndrome”.  It is an important document, as it signifies a major change in attitude towards ME/CFS and casts further doubt on the claimed success of the PACE Trial.  The NIH Statement is unambiguous that the Oxford criteria (used in the PACE trial) are flawed and lack reliability, thereby confounding the ability to interpret results drawn from studies which used them to select cohorts and noting that use of the Oxford criteria may impair progress and cause harm.  The following quotations from the NIH are particularly significant:

• “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.

• “This is not a psychological disease in aetiology.

• “Existing treatment studies (CBT and GET)…(have) not translated to improvements in quality of life.  Thus, they are not a primary treatment strategy.

• “The focus on exercise programmes has further stigmatised and discouraged research participation.

• “Current research has neglected many of the biological factors underlying ME/CFS onset and progression.

• “ME/CFS is a chronic, complex condition…with no cure…..Nothing has improved the lives of the patients.

• “fMRI and imaging technologies should be further studied as diagnostic tools and as methods to better understand the neurologic dysfunction of ME/CFS.

The Conclusions of the draft report reiterate key findings:

• “Specifically, continuing to use the Oxford definition may impair progress and cause harm…Thus, for needed progress to occur we recommend that the Oxford definition be retired”.
        https://prevention.nih.gov/docs/programs/mecfs/ODP-MECFS-DraftReport.pdf

On 10th February 2015 The Institute of Medicine (now called The National Academy of Sciences) released a report entitled “Beyond Myalgic Encephalomyelitis / Chronic Fatigue Syndrome: Redefining an Illness”. The report considered 9,112 published papers on ME/CFS and concluded that it has serious, multi-system pathology and that it is not a behavioural disorder:  It is clear from the evidence compiled by the committee that ME/CFS is a serious, chronic, complex, and multisystem disease that frequently and dramatically limits the activities of affected patients” (http://www.cdc.gov/cfs/toolkit/archived.html).   After publication of that report, the US Centres for Disease Control decided to archive its CFS Toolkit that recommended CBT and GET as interventions for ME/CFS because these interventions have been shown to be scientifically invalid.   The US Agency for Health Research Quality ME/CFS Evidence Review (addendum July 2016) concluded that there was insufficient scientific evidence to support the use of CBT/GET on measurable outcomes like function, fatigue, quality of life, employment, and overall symptom improvement. CBT was also found to be inefficient or barely significant ( https://www.ncbi.nlm.nih.gov/books/NBK379582/?report=reader).  The PACE trial is now widely used to teach medical students how not to run a clinical trial because it provided no usable evidence as a result of serious methodological inadequacy; moreover, the objective data itself is reliable and it indicates that CBT and GET are no better than “usual medical care” which, for people with ME/CFS, is non-existent in the UK.

3. “All the treatments were found to be safe”:   Lord O’Shaughnessy is incorrect in stating that all the treatments used in the PACE trial were found to be safe and that any deterioration in patients’ health was not due to the CBT or GET interventions. Although this claim was indeed made by the PACE Principal Investigators, it has now been demonstrated to be untrue.  There are many reports from PACE participants of the extent to which they deteriorated whilst participating in the PACE trial. Before the PACE results were published, it had been shown beyond doubt that CBT was ineffective and GET was harmful to patients with ME/CFS as revealed in numerous patient surveys (some being professionally analysed) of over 5,000 patients. Well-documented cases of iatrogenic harm resulting from the psychiatrists’ ideological imposition of GET are numerous.  By dismissing symptoms as illusory, not only does this risk harming patients through misdiagnosis, but the “directive” CBT used in the PACE trial (as distinct from the more usual “supportive” CBT) effectively abandons sick people to their own devices, with the result that suicide rates in ME are known to be above average.

4. “In 2013 a follow-up study, looking at recovery after one year, was published.  This study supported the findings that CBT and GET were therapies most likely to lead to recovery”:  this statement is wrong because the 2013 publication does not refer to a separate study, it simply reports a post-hoc analysis of the same PACE trial data and hence cannot be described as supportive since it is the same data.

5. “Since 2011, PACE trial data has been shared with many independent scientists…including the internationally respected research organisation Cochrane, which independently validated the findings”: Lord O’Shaughnessy has been misinformed when he refers to the “internationally respected research organisation Cochrane” as having “independently validated the findings” of the PACE trial.  The PACE trial was not “independently validated” by Cochrane because the PACE PIs themselves were authors of the claimed validation of their own work, the Cochrane review team having included Professor Peter White, the PACE Chief PI, as well as Professor Trudie Chalder, another of the PACE trial PIs, so they were in fact “validating” their own work and beliefs. Importantly, Professor Peter White has a proven financial interest, having personally funded the “Oxford” criteria used in the PACE trial. Furthermore, Professor White contributed financially to the production of the 2014 Cochrane with money from his own academic fund*. Professor James Coyne, Professor of Psychology at the University of Pennsylvania, holder of numerous Visiting Professorships, and author of over 400 papers who was recently designated as one of the 200 most eminent psychologists of the second half of the twentieth century, describes the Cochrane review in question as “untrustworthy” and states that it is complicit in endorsing the PACE investigators’ misinterpretation of their findings.
* http://cochranelibrary-wiley.com/doi/10.1002/14651858.CD011040/full

6. NICE clinical guidelines represent best practice.  They are based on the available evidence”: as Lord O’Shaughnessy confirms in his letter, after years of prevarication, NICE is now committed to a complete rewriting of the 2007 Guideline CG53.  For the avoidance of doubt and contrary to Lord O’Shaughnessy’s assertion, the 2007 Guideline was not based on the available evidence: despite many requests to consider it, NICE intentionally disregarded many thousands of published papers and intentionally excluded from the Guideline Development Group experienced clinicians who were involved on a daily basis with ME/CFS patients and who knew it to be a biomedical disorder.  This was known to be due to the existence of the then-Government’s three-pronged strategy about ME/CFS. The PACE trial was but one arm of this three-pronged strategy and thus needs to be viewed in context. The results were a foregone conclusion in favour of CBT/GET because of the “integrated plan” of the New Labour Government to roll out CBT and GET across the nation for those with ME/CFS (Department of Health, 2004, Statement of Information released via the Welsh Assembly Disclosure Log 2296).  The other two prongs of the three-armed strategy were to be the NICE Clinical Guideline 53 published in August 2007 and the national “Fatigue” Clinics that cost taxpayers £8.5 million to deliver interventions shown to be ineffective in ME/CFS (CBT) and to have made at least 50% of those who have undertaken it significantly worse (GET). 

7. “NICE also makes it clear that…those with CFS/ME have the right to refuse or withdraw from any component of their care plan”:  what Lord O’Shaughnessy fails to mention is that if people with ME/CFS do withdraw from or refuse NICE-recommended interventions of CBT and GET, their State benefits are  often withdrawn.

8. “The Department of Health and Social Care funds research through the National Institute for Health Research (NIHR). The NIHR…is speaking with the UK CFS/ME Research Collaborative (CMRC)…about how best we can support a joined-up approach to high-quality research into this complex disorder”:  Is Lord O’Shaughnessy and his DoH aware that the CMRC started life as the CFS/ME Clinical & Research Network Collaborative (CCRNC), whose CEO was Dr (now Professor) Esther Crawley who was so instrumental in the 2007 NICE Guideline Development Group and whose Collaborative’s charter stated that its objective was “To champion evidence-based approaches to the treatment of CFS/ME, such as those provided in the (2007) NICE Guideline”? Does he know that the CCRNC became the British Association for CFS/ME (known as BACME), again led by Dr Esther Crawley and which, via the MRC CFS/ME expert group (2008-2011) has now morphed into the CMRC? Many patients have expressed a continued distrust of the CMRC despite the change in its Governance, Professor Crawley having resigned as CEO.  That Professor Stephen Holgate remains at the CMRC is an issue for many patients who do not trust him because of his previous roles at the MRC and his very close association with Professor Crawley. He is not considered to be a ‘safe pair of hands’.  Indeed, many patients believe that the changes at the CMRC were a forced ‘cabinet reshuffle’ as a result of the bad publicity around Esther Crawley’s behaviour on various public platforms and because of their failed funding bids for the MEGA project.  Patients and scientists alike are confused about why the CMRC was deemed necessary at all, given that a worldwide collaboration already exists founded by the charity Invest in ME, whose annual London Colloquia and Conferences are attended by leading academics and clinicians.  Of particular concern is that membership of the CMRC includes Action for ME (AfME), who are almost universally distrusted by knowledgeable patients as being “part of the problem, not the solution” and many informed patients will not engage with any organisation where Action for ME has a seat at the table.  An example of this concern is that Action for ME has announced that Professor Cathie Sudlow, now the holder of a personal chair in neurology at Edinburgh, is a conference speaker at the 2018 CMRC conference.  When he was the holder of a personal Chair in psychology at Edinburgh, Professor Michael Sharpe (one of the PACE trial PIs) worked on the Scottish Neurological Symptoms Study and his collaborators included (then Dr) Cathie Sudlow. Professor Sharpe leaked a computer file containing 70 patients’ names and addresses which he sent to a member of the public and it contained confidential information and personal statements made by patients to a number of high-profile clinicians involved in the Scottish Neurological Symptoms Study, including Dr Cathie Sudlow. Examples of the leaked confidential information about the study participants made by those clinicians include the following comments: “putting it on”; “mad”; “imagining symptoms”; “examination was a waste of time”.  The study from which the confidential data was leaked was looking at the prevalence of medically unexplained symptoms (MUS) in new patients attending Scottish Neurology clinics, particularly at “illness-related beliefs and behaviours”, a category in which the study investigators included patients with ME/CFS.

Despite the intransigent insistence by those who are involved in the medical insurance industry that ME/CFS is a behavioural disorder and despite their continued dismissal and ignoring of the ever-increasing scientific evidence that their beliefs about the nature of ME/CFS are unsustainable (permanent health insurance excludes mental disorders from payment if the insured person is unable to work and there is a significant amount of written evidence that PHI companies are determined to avoid pay-outs for ME/CFS), there can no longer be any credible doubt that the biopsychosocial (BPS) model which is the foundation of the CBT/GET paradigm for ME is now comprehensively discredited. 

US research has provided a range of possible biomarkers of organic disease (see https://www.nature.com/articles/s41598-018-28477-9 ).  ME/CFS is a complex, chronic multisystem illness (CMI) for which at least three immunological biomarkers have existed for some time.  The problem in the UK is that NICE specifically proscribes testing for those biomarkers, thereby halting the progress of medical science and denying medical care and support to patients with ME.

By using terms of ignorance such as MUS (medically unexplained symptoms) and abusive language that castigates ME/CFS as mass hysteria or as a behavioural disorder, the BPS model so favoured by certain psychiatrists has been used to belittle and denigrate not only ME/CFS but also patients with environmental illnesses such as organophosphate poisoning (seen in farmers and shepherds), Gulf War Syndrome (seen in veterans of the first Gulf War 1990-1991), Aerotoxic Syndrome (seen in cabin crews and some passengers), the Camelford water poisoning (in which initially seven people died but at least 20 people later died from drinking contaminated water, 25,000 people suffered serious health effects and 40,000 animals were affected: The Ecologist 1999:20:6:228-233; Sue Reid, Daily Mail, 14th December 2007) and chronic Lyme disease. We now know that all these disorders have chronic and multisystem correlates which can be understood and – given adequately funded appropriate research -- eventually treated.

The attempt to group together such CMIs and apply the BPS theory to them has become a cornerstone of contemporary medicine.  It is attractive to Government Departments because it offers interaction with patients that relies on relatively inexpensive talking “therapy”, not on necessary targeted investigations and treatments.

Unless the Parliamentary Under Secretary of State Lord O’Shaughnessy and his DoH cease to support the PACE trial’s alleged “success” and recognises it for the scientific fraud it has been shown to be, patients with the devastating disorder ME/CFS will continue to be abused by UK Departments of State.

In the interests of patient safety and also to ensure that no further public money is spent on ineffective interventions, I look forward to Lord O’Shaughnessy’s prompt response and to his assurance that he and his Department will desist from supporting “research” that is so methodologically flawed that it cannot be relied upon to guide public policy.

With many thanks for your own help.

Yours sincerely

Malcolm Hooper

Wednesday, 18 July 2018

Emperor CDC’s New Clothes

https://relatingtome.net/2018/07/18/emperor-cdcs-new-clothes/

July 18, 2018

by Gabby Klein

The much-anticipated revision of CDC’s website on ‘ME/CFS’ section “Information for Healthcare Providers” was unveiled July 12, 2018.  The main reason for the revision was to adopt and educate medical professionals to diagnose people using the government-sponsored clinical IOM/SEID criteria and to update the toolkit based on current scientific data.

The result of the CDC website update is full of deceptions and in many ways worse than the old toolkit for medical professionals.

Problems and Danger with Adopting and Using the IOM/SEID Criteria

ME advocates have warned that the 2015 government-sponsored IOM/SEID criteria are even worse than the failed and highly criticized government 1994 Fukuda definition.  Critics of the Fukuda definition argue that it was overly broad with too much emphasis on the one common symptom ‘fatigue’. The IOM/SEID definition is even more vague.  Unlike the Fukuda, it doesn’t specify exclusions which means that many people suffering from primary psychiatric and psychological conditions will get a diagnosis of IOM/SEID.

Even worse, the new criteria do not demand any neurological nor immune dysfunction symptoms! Investigators (Dr. Leonard Jason, Frank Twisk and Asprusten et al) who have looked into the IOM/SEID criteria and published papers comparing it with other definitions have warned that it does not define the neuroimmune disease myalgic encephalomyelitis (ME) as defined since 1969 by the World Health Organization (WHO) and coded under Neurological disorders as ICD – G93.3.

The IOM authors clarified this distinction as well.  They stated that the entity they were defining was not a neurological one.  It was a broader entity with subsets which remain to be defined.  They were clearly not defining the distinct disease ME as per our international non-government medical ME experts with their 2011 International Consensus Criteria (ICC). This comparison chart created by the patient organization MEadvocacy.org is an easy visual tool that illuminates the difference.

The danger of using the broad IOM/SEID definition is that the pool of patients diagnosed will be a muddied group.  It will be harmful to those who suffer from ME as per ICC and those who suffer from other conditions for which they lack proper diagnosis.  To properly treat patients one needs to identify precisely the disease they suffer from. It would be like throwing people who suffer from rheumatoid arthritis and osteoarthritis together under one rubric because they share many of the same symptoms. This conflation would be dangerous because as we know, the treatments are entirely different.

Even more alarming, ‘ME/CFS’ investigators working at NIH funded ‘ME/CFS’ consortia are currently using the clinical IOM/SEID to select their cohorts in their studies!  Using this faulty criterion will cause the group to be made up of people suffering from different conditions. The results will be skewed whether searching for a biomarker or successful treatment options. It will be impossible for future researchers, who are unfamiliar with the criteria issues, to duplicate studies as they will have no way to know how to select patients correctly.

Harmful GET recommendation Without the Name Remains on Website

CDC’s previous toolkit for providers recommended graded exercise therapy (GET), stating: “Graded exercise therapy (GET) has shown to be very helpful to some CFS patients. Graded activity and exercise are defined as starting from a very low, basic level of exercise and/or activity and gradually increasing it to a level where people can go about their daily life. NOTE: the level of activity may not be the same as before the CFS diagnosis.”

CDC’s current toolkit treatment section recommends: “Patients who are tolerating their current level of activity and have learned to “listen to their bodies” might benefit from carefully increasing exercise to improve their physical fitness and avoid deconditioning Some healthcare providers with expertise in ME/CFS refer their patients to an exercise physiologist who understands ME/CFS and uses an individualized and flexible approach to advancing activity levels.” [bolding for emphasis]

CDC is in effect still educating doctors to recommend people with ‘ME/CFS’ exercise incrementally.  This description is what graded exercise is, and it is genuinely devious of CDC who many in the community have hailed for supposedly removing GET from their toolkit, only to see them re-introducing it in a concealed manner.  ME advocates and patients who have been on this road with CDC for decades are not surprised at their repeated deceptions. Their malfeasance has no bounds, and they will do anything to cover-up the reality of the neuroimmune disease ME which has appeared in many worldwide outbreaks and the sporadic form.

Dangers of Conflation Which Result in the Burial of ME

CDC states: “There is no consensus on whether CFS and ME are synonyms, different spectrums of the same illness, or distinct conditions.

These words describe the crux of the problem with the government’s attempts to cover-up ME.  It benefits HHS to keep it all a big, muddied, confused heap of nothing.  It has been their intention from the start – to make ‘CFS’ go away. As a 1994 letter obtained through FOIA effort by advocate Craig Maupin from NIAID’s Dr. Straus to Dr. Fukuda states:

“I’ve felt for some time, Kieji, that those that have CFS are at a certain point along a continuum of illness in which fatigue is either the most dominant symptom or the most clearly articulated by virtue of impression on the part of the patient or physician that such a complaint is important. I predict that fatigue itself will remain the subject of considerable interest but the notion of a discrete form of fatiguing illness will evaporate. We would then, be left with Chronic Fatigue that can be distinguished as Idiopathic or Secondary to an identifiable medical or psychiatric disorder. I consider this a desirable outcome.“

HHS and its agencies have purposefully acted to conceal the fact that this is a distinct disease with its distinguished history.  They have repeatedly misbranded (CFS, ME/CFS, SEID), misdefined (Fukuda, Reeve’s, IOM/SEID) the disease to keep the confusion going.  They have also falsely combined ME with CFS as in ME/CFS to perpetuate the confusion. It’s like calling a disease lung cancer/cold!

In the same vein, HHS repeatedly refuses (in contrast with other diseases) to accept and adopt criteria created by the international non-government experts in the disease [Canadian Consensus Criteria (CCC) and ICC] which clarify and distinguish ME.  With the same concealment tactic, CDC erased our experts’ criteria CCC and ICC from their resource section.

Other Tactics Used by CDC to Minimize the Disease

* CDC prides itself on the use of evidence-based scientific data, yet they state on their new website “Some patients return to full function” as if that is a scientifically proven fact.  Which evidence-based studies is CDC relying on when making this positive statement?  I would argue that there is more evidence of people with ME #(pwME) dying from ME than fully recovering from the disease.

* In their Spectrum of ‘ME/CFS,’ CDC states: “For example, patients mildly impaired by ME/CFS may be able—with careful planning and activity management—to keep a job or continue their education, participate in social and family activities, and attend to daily life.” This statement gives the false impression that pwME if managed well, can perform normal activities of life.  It is a false assumption and does not ring true with pwME. For an ME diagnosis, pwME need to have extensive reductions in previous activity.  Activity management might ensure that they do not aggravate their condition and avoid crashing but, it does not improve their base condition.

* CDC states: “From a clinical perspective, case definitions are used to make the appropriate diagnosis and guide therapy and management. From a research perspective, case definitions are used to identify the appropriate study population. Multiple case definitions may be required for different applications and can co-exist if there is a good understanding of how they are being used.” Historically, HHS has conflated the purpose of criteria.  They have used definitions whose goal was for research, in clinical settings and vice versa.  ‘ME/CFS’ investigators are already using the clinical IOM/SEID definition for studies at the NIH funded ‘ME/CFS’ research consortia – despite assurances it by HHS they would solely be used for clinical purposes!

* In CDC’s attempt to conceal any possibility of an infections agent playing a role in ME, they have omitted the history of ME and the fact that it appears in the epidemic for with 50+ worldwide outbreaks.

It is alarming to see this revised CDC criteria in 2018 – more than 30 years after CDC was called down to investigate the massive Lake Tahoe outbreak.  The name, definition and data do not reflect the findings at Lake Tahoe nor the WHO 1969 defining  ME under neurological disorders nor the 2011 International Consensus Criteria defining the distinct disease ME.

ME advocates worldwide are rightfully aligning in their fight against the PACE Trial with their recommendation of the harmful treatments of graded exercise therapy and cognitive behavior therapy.  ME advocates need to do the same with CDC’s revised website which is deceptive because like the Emperor’s New Clothes – it is just more of the same wrongdoing. ME advocates need to rigorously fight CDC’s dangerous recommendation of GET and their use of the vague IOM/SEID definition which will result in the burial of the distinct disease myalgic encephalomyelitis.

Wednesday, 11 July 2018

After that ye have suffered awhile…

http://bible.christiansunite.com/Morning_and_Evening/chme0711.shtml

C H Spurgeon's Morning Devotional for 11th July

"After that ye have suffered awhile, make you perfect, stablish, strengthen, settle you."

1 Peter 5:10

You have seen the arch of heaven as it spans the plain: glorious are its colours, and rare its hues. It is beautiful, but, alas, it passes away, and lo, it is not. The fair colours give way to the fleecy clouds, and the sky is no longer brilliant with the tints of heaven. It is not established. How can it be? A glorious show made up of transitory sun-beams and passing rain-drops, how can it abide? The graces of the Christian character must not resemble the rainbow in its transitory beauty, but, on the contrary, must be stablished, settled, abiding. Seek, O believer, that every good thing you have may be an abiding thing. May your character not be a writing upon the sand, but an inscription upon the rock! May your faith be no "baseless fabric of a vision," but may it be builded of material able to endure that awful fire which shall consume the wood, hay, and stubble of the hypocrite. May you be rooted and grounded in love. May your convictions be deep, your love real, your desires earnest. May your whole life be so settled and established, that all the blasts of hell, and all the storms of earth shall never be able to remove you. But notice how this blessing of being "stablished in the faith" is gained. The apostle's words point us to suffering as the means employed-"After that ye have suffered awhile." It is of no use to hope that we shall be well rooted if no rough winds pass over us. Those old gnarlings on the root of the oak tree, and those strange twistings of the branches, all tell of the many storms that have swept over it, and they are also indicators of the depth into which the roots have forced their way. So the Christian is made strong, and firmly rooted by all the trials and storms of life. Shrink not then from the tempestuous winds of trial, but take comfort, believing that by their rough discipline God is fulfilling this benediction to you.

Thursday, 5 July 2018

After the debate - Call for Change

https://www.change.org/p/carol-monaghan-after-the-debate-call-for-change

Call for Change – Submission to the UK Parliament by the international ME/CFS community

The 21st June 2018 saw a truly amazing debate on ME research and treatment in the UK Parliament.  Now with real hope for the first time, patients have got together to clearly lay out their hopes for the future, in a Call for Change to the UK government.

The full Call for Change can be viewed and downloaded here, though signatures are still being added and a cover page being designed.  Call for Change document

Signatures are invited from the worldwide ME/CFS community.  Signing this petition shows your support of the full content of the Call for Change document.  Patient organisations may back this Call for Change by emailing your name, website and logo to RColourMusic@hotmail.com.

Let's unite with a powerful voice that cannot be ignored!

Here is a summary of the outcomes we call for:

1. Stop CBT and GET immediately.

This is most urgent and must be done without any further delay in order to stop further harming patients.

2. A full public enquiry on how ME has been and is being handled in this country.

*             The PACE trial and the conduct of its authors, the involvement of the Department for Work and Pensions and the insurance industry.

*             The misrepresentation of science through the influence of the PACE authors and proponents of the biopsychosocial model of illness in scientific publications, improperly conducted research and peer review including Cochrane reviews, and the role of scientific journals and their editors.

*             The misrepresentation of science through control of the media.

*             The unethical use of children in dubious clinical trials of dubious and potentially harmful treatments.

*             A close look at the phenomenon of so-called Medically Unexplained Symptoms (MUS) infiltrating our National Health Service, and the new Improving Access to Psychological Therapies (IAPT) programme.

*             Examination of the so-called “secret” files on ME/CFS, held by the Medical Research Council and the Department for Work and Pensions in the National Archives at Kew.

*             The persecution of doctors who have genuinely tried to help their ME patients with a biomedical approach to the illness.

3. Equivalent funding for biomedical research on ME.

This means stopping inappropriate "research" and having the funds diverted to useful research, providing commensurate funding based on disease prevalence and economic burden, and collaborating with existing important players in biomedical research on ME, such as the charity Invest in ME Research which is already setting up a Centre of Excellence at the Norwich Research Park.

4. Medical Education.

The content of medical education on ME should be developed in collaboration with:

*             Practicing ME physicians who take a biomedical approach towards ME.

*             Medical professionals who have ME, some of whom also have a background in Medical Education.

*             NOT Psychiatrists who call themselves CFS specialists.

5. Appropriate and adequate specialist and community services for ME patients, social support and benefits payments.

*             Specialist services should be run by physicians taking a biomedical approach to ME, not Psychiatrists or Mental Health providers.

*             Appropriate inpatient care when ME patients are admitted to hospital, appropriately designed nursing home placements where required, and adequate support for the severely ill who live at home, such as with self-care, shopping, cooking, cleaning, and in some cases tube feeding.

*             Social welfare assessment that is not only fair to ME patients, but avoids exacerbating their illness and worsening their disability.  Assessment protocols and their evidence base should be made available for public scrutiny. 

6. Appropriate and adequate care and support for children with ME.

This means correct diagnosis and recognition, and equal access to education.  The Department of Health and Department of Education should speak to the UK charity Tymes Trust which has extensive experience in, and in-depth knowledge of, the needs of children with ME.

Monday, 2 July 2018

You and ME: An Update on Myalgic Encephalomyelitis for Psychologists by Rose Silvester

https://www.facebook.com/notes/nz-carers-of-kids-with-mecfsrelated-illnesses/you-and-me-an-update-on-myalgic-encephalomyelitis-for-psychologists-by-rose-silv/2102751053086637/ 

Calling it chronic fatigue is a bit like calling a pie “a crust” 
Anna, age 16, personal communication, 2018.

Rose Silvester is a consultant clinical psychologist based in Wellington, New Zealand, currently working at the Regional Personality Disorder Service at Capital & Coast District Health Board (CCDHB). In the context of her son’s illness she has immersed herself in the literature available on ME/CFS and models of care for chronic illness. She is engaged with the global ME/CFS community of researchers, clinicians and advocates and has initiated a national carers support network (NZ carers of kids with ME/CFS and related illness - NZcare4ME) as well as a local carers support group.

This article was first published in the June 2018 edition of the Journal of the New Zealand College of Clinical Psychologists (NZCCP).

My son lives behind the closed door of a dark room. He has been there for two and a half years, he is 17, he has myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). I cannot unlock the door. 

Unlike most other people who have this problem, his onset was not abrupt and not obviously triggered by an assault to the immune system, such as by one of the many associated viruses, or by vaccination, or any event that created significant stress for the body. Toward the end of his primary years, I found myself frequently making excuses for him, for why he was very bright but struggled to be on task, why he went from being in the top 10 in the school cross country to being hundreds of metres behind the last kid, why at soccer following the half time sugar hit that revved the other kids up, he was listless and just watched as the ball rolled past. I blamed it on the insomnia, night sweats, and headaches because they were certainly there, and I thought to myself “kids are weird—they grow out of it.” 

And he did grow out of it—for a time. He had periods of many months where we thought the difficulties had stopped. By the time he reached high school, however, a small cold would see him confined to bed long after the cold symptoms had gone. There was nothing specifically wrong, no fever, vomiting, rash, or cough. He denied that he was tired or fatigued. Nothing. His batteries were just flat. These episodes began to get more frequent, more severe, and his recovery in between, less complete. During one memorable episode, I took him to the GP. He could hardly walk and had to lean against the wall of the corridor to make it to the office. He slurred his words, he was drowsy—he was clearly a very sick kid. After much shoulder shrugging and head scratching we were off for blood tests. While these revealed minor abnormalities (hypoglycaemia, slightly off thyroid function), a blood test could not possibly reveal the problem. These minor things, however, threw everyone off track. And there we remained for over a year. It was during this year that the door began to slowly close. 

Most of the fourth term of year 10 at high school was spent at home. We tried to keep him going. He would get up, get ready for school, but be stopped in his tracks by body aches, headaches, and weakness. He was dizzy and fainted half a dozen times. His heart rate while standing would soar to 140 bpm and stay there. We know now that these early symptoms were the hallmark orthostatic symptoms of postural orthostatic tachycardia that often precede full syndrome ME/CFS. He spent most of the term at home and did gradually recover—enough to have a good summer. Again, we thought “it” whatever “it” was, was going to leave him alone. He was excited to go to school with his mates on the first day of year 11. At Wellington High School, year 11 kids are allowed to go to town at lunch time and he took full advantage of the freedom. He came home happy. That night, sometime while he slept, the door slammed shut. He has not been able to return to school. 

Myalgic encephalomyelitis (my*al*gic + en*ceph*a*lo*my*eli*tis) (ME), is commonly referred to as chronic fatigue syndrome (ME/CFS). We eventually achieved this diagnosis, but too late to be aware of the cumulatively damaging effects of the episodes of unwellness that we now know were “crashes.” The need for careful pacing was never discussed. Too late too, to take advantage of the potential that managing his orthostatic symptoms more effectively may have reduced some of the stress his body was under. 

The Institute of Medicine (IOM) describes ME/CFS is a serious, chronic disease that affects an estimated 0.5%–1% of people (Institute of Medicine, 2015). There is no known definitive aetiology or effective treatment. Diagnosing the disease remains a challenge, and patients often struggle with their illness for years before identification is made. Recovery of pre-illness functioning is rare. Seventy-five percent are unable to return to pre-illness levels of work or study. Many people with ME/CFS are more impaired in their functioning than those with other chronic and disabling illnesses, including type 2 diabetes mellitus, congestive heart failure, hypertension, depression, multiple sclerosis, and end-stage renal disease (Twisk, 2014). Women are more likely than men to be afflicted, and although peak onset is in adulthood, children also commonly get ME/CFS. It is estimated that as many as 90% of people (across all ranges of severity) are not diagnosed (Institute of Medicine 2015). 

The cause remains unknown, but currently the most likely contender is that it is a systemic disease, and that in vulnerable (most likely genetically vulnerable) individuals, an assault to the immune system causes an abnormal immune response, which in turn causes an inflammatory reaction that affects the whole body right down to the level of mitochondrial energy production. In particular, it seems that the autonomic nervous system becomes unbalanced, leaving people stuck in a state of sympathetic overdrive—a constant state of fight or flight affecting heart rate and blood pressure (orthostatic regulation), temperature regulation, pupillary reaction, digestion, sensory filtering, emotional regulation, and so on. Pain in joints and/or the generalised ache of the first few days of the flu is usual. Cognitively, the effects can, for some, be devastating. Widespread endocrine abnormalities in many people suggest that the delicate balance of the hypothalamic-pituitary-adrenal axis has wobbled. Not surprisingly, sleep becomes inefficient and unrefreshing. Homeostasis is wrecked. It is exhausting. Post-exertional malaise is a hallmark symptom. It simply means that the window for tolerating any exertion, be it physical, cognitive, or emotional has narrowed. A marked worsening of symptoms occurs in the 12–72 hours following exertion. This worsening, sometimes called a crash, can persist for days, weeks, months, or years. Inter-episode recovery decreases with each crash. For around 25% of people, the window narrows to a point whereby activities of independent living are not possible. They are confined to their houses. Many are bed bound. 

The pathophysiology of ME/CFS is very, very complicated. While recent research has identified a range of biomarkers and metabolic abnormalities in people with ME, these tests remain tools of research. Diagnosis is by symptom identification and exclusion of other illnesses that may present in a similar way. Over the last few decades, diagnostic criteria for ME/CFS have been widely debated. In 2015, the National Academy of Medicine published new diagnostic criteria for ME/CFS requiring the presence of: substantial impairment in activity that lasts 6 months or more and is accompanied by fatigue, post-exertional malaise, unrefreshing sleep, and either cognitive impairment or orthostatic intolerance (Institute of Medicine 2015). These criteria are, on the face of it, a massive simplification of a very complex picture in which the likelihood of multiple disease processes exists. Agreement and consistency of definition is, however, welcome. 

The label “ME/CFS” has been similarly debated. Clinicians, researchers, and people with ME/CFS have pushed back, particularly against the label of chronic fatigue, arguing that it minimises the breadth and savagery of symptoms. It also has the unfortunate history of the misunderstanding and minimisation that came with derogatory labels such as “yuppie flu.” While the term CFS is rapidly on its way out, ME (for now) remains (grudgingly), and the IOM label of systemic exertional intolerance disease is on its way in (Institute of Medicine, 2015). 

ME/CFS has not had an easy history, and it continues to sit uncomfortably. The diagnosis has fallen victim to the kind of stigma and marginalisation that is common when we are faced with things we cannot easily test or measure. The notion that ME/CFS can be formulated as a psychogenic disorder, such as conversion disorder or somatoform disorder has prevailed in both the medical and psychological communities. 

Early hypotheses of psychological causation have long since been countered by growing research showing biological correlates of ME/CFS not found in depression or any other psychiatric disorder (Stein, 2005). The prevalence of known psychiatric disorders among patients with ME/CFS is similar to the rates in patients with other chronic, disabling medical conditions, such as rheumatoid arthritis; approximately 30%–40% (Thieme, Turk, & Flor, 2004). The World Health Organization classifies ME/CFS in the International Classification of Diseases, tenth revision as a neurological disorder (ICD 93.3). Little evidence exists for any disorder in this category conforming to a psychogenic formulation (Wilshire & Ward, 2016). Healthcare providers, however, remain sceptical about the physiological—rather than psychological—nature of the illness. “Once diagnosed, patients often complain of receiving hostility from their healthcare provider as well as being subjected to treatment strategies that exacerbate their symptoms” (Institute of Medicine, 2015). Within the ME/CFS community, anecdotes of gas- lighting and exclusion from treatment are the norm. I would suggest, where scepticism or doubt exists for health providers, that these notions are grossly outdated and perhaps “all in their heads.” 

Psychology, and particularly cognitive behavioural therapy (CBT), has for some time been positioned in the centre of this discomfort. In recent decades, the officially recommended treatments for chronic fatigue syndrome (ME/CFS) have been graded exercise therapy (GET) and CBT. These treatments are formulated to satisfy the premise that ME/CFS symptoms are precipitated by factors such as trauma, prolonged stress, or personality factors, and are perpetuated by avoidance of activity and aberrant illness beliefs (Wilshire & Ward, 2016). The idea is that graded desensitisation (to the anxiety produced by activity) will help the individual to appreciate that pain and fatigue are not harmful. I recently Googled ME/CFS and CBT—the first entry that came up sums up this position: 

...illness beliefs may lead to disability, as people obsess about their symptoms, entrench themselves in the conviction of organicity, and become disabled. Their marriages may break up; they may lose their jobs. The human consequences of these illness beliefs, in other words, may be considerable. Joining a sufferers’ support group that will irreversibly confer a label is really the last step on this pathway to disability. (Shorter, 2015) 

Based on the assumption that psychological factors both precipitate and perpetuate the disorder, and in an attempt to provide evidence of the efficacy of CBT and GET, White and colleagues undertook a large-scale randomised trial (White, Goldsmith, Johnson, & Potts, 2011). This was colloquially referred to as the PACE trial. Reports published in reputable journals (including The Lancet) concluded that the PACE graded exercise and CBT protocols were moderately effective treatments for ME/CFS, leading to “recovery” in over one-fifth of patients. The trial’s size and subsequent promotion of CBT and GET as a gold standard treatment became hugely influential in the development of treatment guidelines, including the National Institute for Health and Care Excellence (NICE, 2007) and Centre for Disease Control (CDC) guidelines. 

Soon after publication, however, there began a clamour of dissent. People with ME/CFS were perplexed, stating that the premise was incorrect and that, in their experience GET and CBT were not only ineffective, but were harmful. In forcing people with ME outside of their safe window of energy consumption, they risked a crash. The result, for many, was catastrophic. There also emerged significant concerns about the methodology of the trial. Sitting at the tip of this rather large iceberg of concerns was that the outcomes and analyses reported did not follow the original published protocol (Wilshire et al., 2018). This was troubling given that the purpose of a trial protocol is to prevent post hoc changes to methodology that may favour the study hypotheses. Also, it was doubtful whether the trial’s conclusions about treatment efficacy were justified by the evidence. David Tuller, a critic and prolific writer on the failures of the PACE trials reported a “bizarre paradox” (Tuller, 2015). The scores that determined whether someone qualified as disabled enough to enter the trial could simultaneously qualify them as “recovered” (by the definition of the outcome measures). A full 13% had “recovered” before the trial started, based on the change in protocol that occurred months after data collection ended (Tuller, 2015). 

It is in this context that within a few years, the clamour turned into a furore, and accusations as strong as scientific fraud were levelled against the PACE trial authors by the ME/CFS research community. In 2015, an open letter was written to Richard Horton, Editor of The Lancet, by eminent researchers in the field of ME/CFS, including Ron Davis, Professor of Biochemistry and Genetics at Stanford University (and a current leading light in the ME/CFS research community as well as father to Witney, a young man with very severe ME/CFS). The letter raised concerns about “serious ethical breaches in the study” and stated that the flaws inherent in the study “have no place in published research.” This was strongly worded criticism, and went on to say the shortcomings were “of particular concern because of its significant impact on government policy, public health practice, clinical care, and decisions about disability insurance and other social benefits.” The Lancet was urged to “seek an independent re-analysis of the individual-level PACE trial data, with appropriate sensitivity analyses, from highly respected reviewers with extensive expertise in statistics and study design” (Davis et al., 2015). 

While voluminous discussion and reanalysis has subsequently been published, reanalysis was hampered by the refusal of the original authors and PACE trial committee to release the original dataset for scrutiny. These data were, however, recently obtained as part of a Freedom of Information application, and made available to the public. In March this year, a new player walked onto this complex stage with the publication of a reanalysis of the PACE trial using this previously unavailable original data (Wilshire et al., 2018). Imagine my surprise when the author turned out to be Dr Carolyn Wilshire, from the School of Psychology at Victoria University. We talked about the big picture and her findings over coffee in Aro Street. 

Carolyn Wilshire’s thorough and hopefully definitive reanalysis of the PACE trial concluded that, despite the power of the study afforded by the large sample size, the results were “modest, short- lived changes in self-report behaviour unaccompanied by objectively measurable changes.” She further commented that “it seems unlikely that further research based on these treatments will yield more favourable results” and “the time has come to look elsewhere for effective treatments” (Wilshire et al., 2018). Even the use of CBT for basic distress reduction has been called into question with the results of repeated patient surveys indicating that for many, CBT is harmful (Laws, 2017). Last year, in response to these contradictions, the CDC quietly changed its ME/CFS treatment guideline, removing any reference to GET and CBT, and clearly stating the likely harm (CDC, 2017). Similarly the NICE guidelines group announced a revision and specifically cited conflicts in the evidence for GET and CBT as a major basis for review (NICE, 2017). Current major National Institute of Health (the major US health research funder) research initiatives are focused on the pathophysiology of ME/CFS. The hope of the ME/CFS community is that these initiatives will play a key role in generating new treatment paradigms (Wilshire et al., 2018). 

But the research initiatives to which Carolyn Wilshire refers are, in the scheme of things, in their infancy and comparatively poorly funded. Crowd funding and private donations for research remain common. For example, Ron Davis’ research has this year been funded by patients, and the Pineapple Fund, a fund provided by a private Bitcoin investor. Investigations into ME/CFS have lagged so far behind other disorders that some of the figures would be comical if they were not so tragic. Jorgen Jelstad (2016) quantified this inequity, and noted that although the measures of quality of life of people with ME fall below that of people with multiple sclerosis, more is spent on research into MS every year than has ever been spent on ME/CFS. Research into HIV/AIDS in the US attracts around 600 times the funding, although HIV affects similar numbers of people, with better outcomes. Male pattern baldness gets six times more federal funding than ME/CFS in the US (Jelstad, 2016). It is not so strange then, that it is taking time to find any credible answers to the ME/CFS enigma. Nancy Klimas, Professor of Microbiology and Immunology and one of the more prominent ME/CFS specialist clinicians (there are only a handful) was quoted in the New York times in 2009: 

My HIV patients for the most part are hale and hearty thanks to three decades of intense and excellent research and billions of dollars invested. Many of my ME/CFS patients, on the other hand, are terribly ill and unable to work or participate in the care of their families. I split my clinical time between the two illnesses, and I can tell you if I had to choose between the two illnesses (in 2009) I would rather have HIV. (Klimas, 2009) 

This lack of research is a barometer of a broader issue of the value that the health sector places on people with ME. Let me give you an example that is very close to home. A recent meeting for a very elderly relative who was moving to palliative care was attended by the geriatrician, rest home manager, charge nurse, dietician, social worker, and psychologist. While I am loath to sound petulant, my son, who is so very unwell, is seen by one physician around every 4 months. This physician has worked hard to consult and refer where possible. The waiting and time to get answers has however, been interminable. Even for some simple and commonly used specialist consultations it has been years. This is such a long time in a young person’s life at a critical developmental stage. Our health system is not designed to deal with complex problems involving multiple organ systems. If I had a magic wand I would conjure up specialist integrated teams of clinicians (physicians, cardiologists, endocrinologists, immunologists, neurologists, physiotherapists, occupational therapists, psychologists, and social workers) who would work together to optimise the management and quality of life for all people with ME. 

So where does this leave psychology in supporting this population? Did you, like me, see the baby sailing through the air with the PACE trial bathwater? The downstream effect of the PACE study is that in all the fuss the real value of psychology for people with ME has been neglected and remains ambiguous. For myself, I know that there is a lot to be gained from acceptance of what-ifs of the past, the grief of the present, and the uncertainty of the future. De-fusing from the guilt and fear demons that come flapping in the night. It has become important to be mindful of the moment and to connect with what is present, here and now, in all its limitations as well as possibilities—and to find value in this. And...to remain open to a new identity as it emerges: advocate, activist, educator, supporter, and friend to the community of people with ME and their carers. The support my son needs, if he were well enough, would be very similar and would also include finding the window of energy tolerance, establishing a routine around this and developing values and an identity within his limitations. You may notice that none of this involves an assumption that if he just pushed a little harder he would be ok, or a focus on aberrant illness beliefs. We went there. It failed. 

Late last year the face of ME/CFS changed. Completely. Unrest, a documentary by Jennifer Brea was released and subsequently avalanched with awards. Jenn (yeah it feels like she’s been in my living room), a person with ME wrote and directed Unrest, largely from her bed. It is brave, informative and heart-breaking. She collaborated with families, researchers and clinicians— including Ron Davis and his family—and provided a focus for people with ME and their advocates around the world. Unrest has been shown at thousands of public education events and is now being used as part of the curriculum at universities such as Harvard Medical School. From the momentum that Unrest unleashed, MEAction was born. This group works tirelessly to promote Unrest and to galvanise a community of activists. A clear direction for advocacy and education has now been illuminated. Please watch Unrest. It is on Netflix and Itunes. 

So...what of my son? I wrote a paragraph on how he is now, then decided that he would not want you to know the details. He remains severely disabled. The door to the room that confines him is firmly shut and has a thousand locks on it. In our hands there are a thousand keys. Every 4 months or so, when we meet with his very caring physician, we get to choose whether we keep wriggling the current key in the current lock, or try a different combination. In the vacuum of knowledge about the real mechanisms that drive ME/CFS there is little to guide our choice. And so, we wait.

Thanks to my friends (NZcare4ME) who are along for the ride, and helped with references. 

References 

Center for Disease Control. (2017). Myalgic encephalomyelitis/chronic fatigue syndrome. Retrieved from https://www.cdc.gov/me-cfs/index.html

Davis, R., Jonathan, C. W., Jason, L., Levin, B., Racaniello, V. R., & Reingold, A. (2015). An open letter to Dr Richard Horton and The Lancet. Virology Blog. Retrieved from http://www.virology.ws/2015/11/13/an- open-letter-to-dr-richard-horton-and-the-lancet/

Institute of Medicine. (2015) Beyond myalgic encephalomyelitis/chronic fatigue syndrome: Redefining an illness. Washington, DC: The National Academies Press. 

Jelstad, J. (2016). The male pattern baldness disease? Chronic fatigue syndrome’s chronic lack of research funding. Retrieved from https://www.healthrising.org/blog/2016/05/04/chronic-lack-funds-chronic-fatigue- syndrome-mecfs-research/

Klimas, N. (2009). A virus linked to chronic fatigue syndrome. New York Times Laws, K. R. (2017). Distress signals: Does cognitive behavioural therapy reduce or increase distress in chronic fatigue syndrome/myalgic encephalomyelitis? Journal of Health Psychology, 22(9), 1177–1180. National Institute for Health and Clinical Excellence. (2007). Chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy): Diagnosis and management of CFS/ME in adults and children. Retrieved from https://www.nice.org.uk/guidance/cg53/evidence/full-guideline-pdf-196524109

National Institute for Health and Clinical Excellence. (2017). Surveillance report. Chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy): diagnosis and management (2007) NICE guideline CG53. Retrieved from https://www.nice.org.uk/guidance/cg53/resources/surveillance-report-2017-chronic-%20fatigue-syndromemyalgic-encephalomyelitis-or-encephalopathy-diagnosis-and-management-2007-nice-%20guideline-cg53-4602203537/chapter/how-we-made-the-decision#how-we-made-the-decision  

Shorter, E. (2015) Chronic fatigue in the context of the history of medicine. Retrieved from https://www.psychologytoday.com/us/blog/how-everyone-became-depressed/201502/chronic-fatigue- 

Stein, E. (2005). Chronic fatigue syndrome. Psychiatric Treatment Guidelines. Retrieved from https://anzmes.org.nz/

Thieme, K., Turk, D. C., & Flor, H. (2004). Comorbid depression and anxiety in fibromyalgia syndrome: relationship to somatic and psychosocial variables. Psychosomatic Medicine, 66, 837–844. 

Tuller, D. (2015). Trial by error: The troubling case of the PACE chronic fatigue syndrome study. Retrieved from http://www.virology.ws/2015/10/22/trial-by-error-ii/

White, P. D., Goldsmith, K. A., Johnson, A. L., & Potts, L. (2011). 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. 377(9768), 823–36. 

Wilshire, C. R., Kindlon, T., Courtney, R., Matthees, A., Tuller, D., Geraghty, K., & Levin, B. (2018). Re-thinking the treatment of chronic fatigue syndrome—a reanalysis and evaluation of findings from a recent major trial of graded exercise and CBT. BMC, 6, 6. Retrieved from https://bmcpsychology.biomedcentral.com/articles/10.1186/s40359-018-0218-3#Bib1

Wilshire, C. E., & Ward, T. (2016). Psychogenic explanations of physical illness: time to examine the evidence. Perspectives on Psychological Science, 11(5), 606.