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Academics and even a major charity’s medical advisor have been signing up to Prof Wessely’s attempts to hold patients responsible for the dearth of research here in the UK, but in the USA things have been moving in a direction which delights patients and carers and brings hope to us all in an otherwise very depressing situation.

The Open Medicine Institute in California was set up in 2009 by Dr Andreas Kogelnik. The website says –

“Patients with ME/CFS desperately need answers. We are convinced these answers are readily available if we apply the best resources in a large-scale, concerted effort. Bringing together the right experts and the most advanced technologies to deliver actionable results is a necessary condition for success that has been a long time coming to this field.”

“OMI-MERIT (ME Roundtable on Immunology and Treatment) is a strategic initiative of OMI and its collaborators to bring together leading clinicians and researchers to tackle this debilitating but underserved disease. The MERIT group is focused on developing and applying a multi-factorial approach to the discovery of new diagnostic and treatment solutions for ME/CFS.”

OMI have a  focus on Neuroimmune Diseases and Cancer. “The Institute is currently focused on understanding, developing treatments, and finding cures for neuro-immune diseases including ME/CFS (Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, Autism, Multiple Sclerosis, and other conditions. There are also plans to apply the Institute’s model to a range of diseases including cancer and Alzheimer’s—diseases which have proved difficult, if not impossible, to decode and treat using today’s standard approaches.”

Their priority projects are listed and described at  http://openmedicineinstitute.org/research-initiatives/mecfs-merit/  They include

1-Treatment: Phase 1: A Large-scale, Randomized, Placebo-controlled Trial of Rituximab and Valgancyclovir

2 – An International Neuro Registry and Biobank

3 – Protein Panel in Treated and Untreated Patients

4 – Treatment: Phase 2: Other Therapy Mono and Combination Pilots

5 – Immunologic Biomarker Exploration Studies

6 – DNA Genetics

7 – Comprehensive Viral Testing

8 – Advanced Immunologic Biomarker Study 2

10 – Treatment: Phase 3: Natural and Over-the-Counter Substances  -will include Moringa olifera, GcMAF, Vit B12, and artemesin

There is a very impressive International list of those involved – OMI-MERIT Initiative Signators (in Alphabetical Order)

Drs. Lucinda Bateman (Fatigue Consultation Clinic & Univ of Utah, UT, US),  Allison Bested (Complex Chronic Disease Clinic, Canada),   Yenan Bryceson (Karolinska Institute, Sweden),   Ron Davis (Stanford Genome Technology Center, CA, US),   David Dreyfus (Yale/Private practice, US/Israel),   Oystein Fluge (Haukeland University Hospital, Norway),   Mady Hornig (Columbia Univ, NY, US),   Nancy Klimas (NOVA Univ, FL, US),   Andy Kogelnik – Chair (Open Medicine Institute, CA, US),   Charles Lapp (Hunter Hopkins Center, NC, US),   Jay Levy (UCSF, CA, US),   Alan Light (University of Utah, UT, US),   Kathleen Light (University of Utah, UT, USA),   Sonya Marshall-Gradisnik (Griffith University, Australia),   Mauro Malnati (San Raffaele Scientific Institute, Italy),   Olav Mella (Haukeland University Hospital, Norway),   Jose Montoya (Stanford University, CA, US),   David Patrick (Complex Chronic Disease Clinic, Canada),   Dan Peterson (OMI and Sierra Internal Medicine, NV, US),   Simone Pensieroso (San Raffaele Scientific Institute, Italy),   Peter Rowe (Johns Hopkins, US),   Charles Shepherd (Private practice, UK),   Ila Singh (Mount Sinai School of Medicine, NY, US),   Carmen Scheibenbogen (Charité Berlin, Germany),   Chris Snell (University of the Pacific, US),   Staci Stevens (Open Medicine Institute, US) and  Rosamund Vallings (Private practice, New Zealand).

Psychiatric Diagnoses are categorised by the DSM-IV which stands for the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition  This manual is published by the American Psychiatric Association. It covers all mental health disorders for both children and adults and is considered to be the ultimate guide for doctors and insurance companies. It is currently in the final stages of being revised for DSM-5.

The chair of the DSM-IV Task force was Allen J Frances, MD. He was chair of the Department of Psychiatry at Duke University School of Medicine and is currently Professor Emeritus  there. He has grave concerns about the new revision of DSM-IV, as he explains in this article at Psychology Today. Dec 8th 2012. Here.  http://www.psychologytoday.com/blog/dsm5-in-distress/201212/mislabeling-medical-illness-mental-disorder

“…Adding to the woes of the medically ill could be one of the biggest problems caused by DSM 5. It will do this in two ways: 1) by encouraging a quick jump to the erroneous conclusion that someone’s physical symptoms are ‘all in the head’; and 2) by mislabeling as mental disorders what are really just the normal emotional reactions that people understandably have in response to a medical illness…”

Today’s Independent on Sunday (2nd Dec.2012) publishes a letter signed by 27 medical
professionals — who may be described as supporters of the psychosocial
model of ME/CFS — in which they refer to the harassment of some researchers
working in the field.

It is regrettable that the wholly unacceptable actions of a few people have
not only undermined the efforts of those who, for many years, have sought to
engage scientifically with proponents of the psychosocial model but have
tarnished the reputation of all ME/CFS sufferers. Further, it has allowed a
narrative to develop, namely that ME/CFS patients are prejudiced against
psychiatry and are resistant to the possible role of psychological factors
in their illness. A siege-like mentality has developed between patients and
doctors and it is essential, if progress is to be made, to move beyond this
impasse towards a constructive dialogue based on evidence, so that if the
psychosocial model is found wanting, a commitment can be made to look for
alternative causal mechanisms.

Much of the recent frustration has stemmed from the presentation of PACE
Trial data in The Lancet (published online February 18 2011) and other
journals. For example, in their accompanying editorial in The Lancet,
Bleijenberg and Knoop wrote: “PACE used a strict criterion for recovery…In
accordance with this criterion, the recovery rate of cognitive behaviour
therapy and graded exercise therapy was about 30%”, with another journal
reporting “a recovery rate of 30-40%” (BMC Health Serv Res. 2011; 11: 217,
three of the authors being signatories to the letter to the Independent on
Sunday).

Both these reports are wrong, because no recovery data from the trial have
been published, and although The Lancet’s senior editor, Zoe Mullan,
acknowledged this error and promised to publish a correction, to date (22
months after publication) no correction has been issued, allowing this
misrepresentation to continue.

The above are but two of many well documented discrepancies surrounding the
publication of selective results of the PACE Trial.

In their letter, the signatories say that the harassment: “risks undermining
research, preventing the development of new treatments and discouraging
specialist clinicians from entering the field. We fear that this may have
resulted in patients not receiving the best treatments or care”.

Quite apart from the fact that the signatories’ favoured treatment may not
be the best for people with ME/CFS, the signatories make no distinction
between “extremists” and those who continue to present reasoned,
evidence-based critiques of the psychosocial model. Moreover, they appear to
have conflated criticism of a particular psychiatric theory with the
wholesale rejection of psychiatry per se: being critical of certain
psychiatrists’ beliefs about the causation of ME/CFS is not the same as
being anti-psychiatry.

The psychosocial model has been subject to challenge because when its
predictions were tested empirically, such as in the FINE and PACE Trials,
objective data from these trials show clearly that ME/CFS is not perpetuated
by dysfunctional thinking and deconditioning as the model posits.

People are angry, but that’s because a small group of psychiatrists who have
consumed such a large share of research funding for twenty years have acted
in a way that is perceived to be wholly unscientific ie. when the evidence
(even from their own studies) shows their ideas to be wrong, they either
ignore the evidence (eg. FINE), or appear to misrepresent it (eg. PACE), and
the system which is meant to protect against this – academic peer review –
has completely failed to prevent the dissemination of papers which contain
egregious errors.

It is also the case that many patients and clinicians alike feel let down by
the wider scientific community for not speaking out against apparent abuses
of process such as the post hoc revision of  primary outcome measures in the
PACE Trial which made it possible for a participant to deteriorate after
treatment but still be described as “recovered”.  Had such a situation
applied in a drug trial there would, rightly, have been an outcry.

For the proponents of the psychosocial model to continue to ignore the
biomedical evidence from world-class experts such as Drs Nancy Klimas, Mary
Ann Fletcher, Anthony Komaroff, Kathy and Alan Light and Dan Peterson must
surely conflict with a clinician’s first duty to patients, as rejection of
that evidence may carry the risk of iatrogenic harm.
As Professor Komaroff wrote in Nature Reviews Neuroscience, September 2011:
“Many of the documented abnormalities involve the central and autonomic
nervous systems. In my experience, most sceptics are unaware of the
extensive literature citing such abnormalities and become less sceptical
upon reading it”.
Professor Klimas was equally clear about those who dismiss the biomedical
evidence, saying at the IACFSME Conference in September 2011: “Look at the
studies of many patients – and they tell you the same. It is not
difficult. I mean immune findings in ME / CFS is proved. It is not
controversial, and it is not just a hypothesis. There is immune activation,
it is dysfunctional cells and a significant degree of malfunction of the
immune system….I have no difficulty (saying) with great certainty that the
immune system in ME/CFS is not working as it should”.
Given the well-established body of biomedical evidence and the failure of
CBT and GET to produce objective benefits, people diagnosed with ME/CFS (and
the clinicians who support them) struggle to comprehend the continued
propagation of the doctrine that they can be cured and be returned to
employment by psychotherapy, when the evidence from the psychosocial studies
shows this is not the case.

It is time for a more productive dialectic so that patients can receive
treatment and support based on sound evidence and researchers can work
without fear.

(Permission has been given to repost.)

“I have been assured that Her Majesty’s Government accept the WHO’s categorisation of ME as a neurological condition. The CMO report of 2002 described it as a “genuine illness” which,“imposes a substantial burden on the health of the UK population”.

The NICE guideline of 2007 stated that:  “The physical symptoms can be as disabling as multiple sclerosis, systemic lupus erythematosus, rheumatoid arthritis, congestive heart failure and other chronic conditions”.

Yet there is no provision to examine the neurological aspects of this illness. Patients are simply allocated to either the CFS/ME group, where they are offered psychological therapies, or to various ad hoc diagnostic categories containing patients with neurological symptoms of unknown aetiology. In practice, these can be considered dustbins where no further investigations are considered necessary.

After the Chief Medical Officer’s report on CFS/ME in 2002, £8.5 million was allocated to setting up specialist ME centres. Some of the centres have closed because of a lack of funding. Others continue to operate but are somewhat constricted by the view that the only scientifically validated treatment for the condition is a combination of cognitive behaviour therapy and guided exercise training-CBT and GET. In fact, the much trumpeted PACE trials, which cost the taxpayer some £5 million and were intended to demonstrate the effectiveness of these so-called treatments, did no such thing. There is no indication in the trial results that one single person fully recovered after a year of CBT and GET. There is no indication that any who were not working went back to work or, in fact, that there was more than a very modest improvement in those whose health was deemed to have improved.” ….. continues – see here – column 1791

Hexham Forum Cinema screening of Voices from the Shadows on Sat 24th November at 5pm. followed by  a Q&A session with Dr Nigel Speight. Admission is free but please ring 01434 601144 after 4.30pm to book a place. This screening has been organised by Margaret Rumney and her daughter Emma who made the posters and adverts.  They are delighted that when they invited their MP along he agreed to attend.

Dr Nigel Speight is a Consultant Paediatrician from Durham who has been involved with children with ME and their families for many, many years. He is considered to be the most experienced UK paediatrician involved with ME, being the paediatric medical advisor for the ME Association and TYMES Trust as well as the medical advisor for the 25% Group and the Welsh ME charity WAMES. Through his work for The 25% Group he is becoming involved in more and more shocking cases where very seriously ill people are not only not receiving the care they need, but they are suffering at the hands of professionals. Dr Speight was a member of the Chief Medical Officer’s Working Group which produced a Report on ME in 2002  and more recently he was a member of the team which produced the highly respected and specific ‘International Consensus Criteria for ME’ in 2011 (updating the Canadian Consensus Criteria). Most recently he helped with the valuable ‘Myalgic Encephalomyelitis International Consensus Primer for Medical Practitioners’ 2012. The Primer can be downloaded from this site www.hetalternatief.org/ICC%20primer%202012.pdf to give to your doctor to help with more accurate diagnosis and treatment options. Sadly, misdiagnosis is currently widespread and is causing untold suffering both to those with ME and to those wrongly diagnosed with ME when they have other more easily treatable and even curable conditions. Both this Primer and the one recently written by the IACFS/ME should go a long way to countering the high levels of misunderstanding caused by the NICE Guideline and the  CDC or Oxford descriptions of CFS/ME.

ME Analysis is a group of people who have carefully examined the results of the PACE Trial, in so far as they have been published. Further details are due to be released under a Freedom of Information request.   Their analysis can found on Phoenix Rising here.  ME  Analysis have  just released the fourth in their series of short videos with little animations demonstrating the results of the PACE trial in a simple and easy to understand manner. They are available to watch on their youtube page here.

Their analysis shows a very different picture to that portrayed by the media and the official statements released by the Science Media Centre. For example Dr A Miller the chief medical advisor for Action for ME wrote, rather astonishingly in the light of the actual evidence – “This trial represents the highest grade of clinical evidence – a large randomized clinical trial, carefully designed, rigorously conducted and scrupulously analysed and reported. It provides convincing evidence that GET and CBT are safe and effective and should be widely available for our patients with CFS/ME.”

It is interesting to compare the PACE trial methodology with Prof Lipkin’s description of his XMRV research where he described how a well designed trial should be constructed; with criteria and method unanimously decided upon before starting (by the most knowledgeable professionals in the field)  and then strictly adhered to without any changes, so as to give an unbiased result. This is not what happened with the PACE Trial, which could not be described by any stretch of the imagination as “the highest grade of clinical evidence”.

Rosemary Underhill  trained as a physician, a surgeon and an obstetrician in London. Recently she submitted a testimony to the October 2012 CFS Advisory Committee meeting. In it she calls for investigation of the subgroup of patients with ME/CFS which occurs in cluster outbreaks. The document is available on the Vermont CFIDS Association website here  

She says, “it is often stated that ME/CFS is not contagious. There is however much evidence that this disease can be communicable”. She requests the CFSAC to “recommend that the CDCs Epidemic Intelligence Service (EIS) investigate this subgroup of patients with ME/CFS….  that the EIS and the ME/CFS research community seek out cluster outbreaks of every illness resembling ME/CFS and investigate both the patients and their close contacts in the hope of finding the causal pathogen.”

She also states that “the case definition for patients in cluster outbreaks needs to be refined” and says: “Patients from cluster outbreaks need to be tested for unknown pathogens as well as known pathogens. Especially is the need to look for neurotropic and a B lymphotropic virus, which can inhibit killer cell activity, which has the ability to become latent, which may be able to inhibit replication of the polio virus and which may be difficult to culture.”

Rosemary Underhill was a member of the writing committee for the Chronic Fatigue Syndrome, Myalgic Encephalomyelitis – Primer  for Clinical Practitioners. It was produced by the International Association for CFS/ME and released earlier this year. It is a very informative, well written and easily accessible document. In June the CFS Advisory Committee formally recommend that the CDC Toolkit be removed from the CDC CFS website and that, instead, the more accurate  International Association CFS/ME Primer be made widely available to primary care physicians. The CDC refused to remove the Tool kit which recommends CBT and GET without mention of the harm that is likely to be caused to many patients: specifically those who fulfil the Intenational Consensus Criteria for ME which includes  as a crucial and compulsory symptom Post-Exertional Neuroimmune Exhaustion.

Emily Collingridge died from ME last March. Her  funeral will take place on Tuesday, 6th November 2012 at 12.45pm. Information for her friends wishing to  take part in a ‘virtual funeral’ is on the ME Association website  here http://www.meassociation.org.uk/?p=13356

One of the best ways of remembering Emily is, I think, to continue her work and read her appeal below.  Emily first wrote to me to ask if she could contribute to the book Lost Voices from a Hidden Illness. She later provided more photos for us to use in the film Voices from the Shadows. She had by then suffered further awful relapses and hospitalisation. I was immensely impressed by her determination and the rigour with which she paced and organised her days in order to be able to achieve so much in conditions which most people would have found totally impossible. She showed me her timetable which gave her a few very short periods of a matter of minutes, spaced out over the 24 hour day, in which she could carry out these activities which she planned weeks in advance. Amazingly, in this way she wrote her own book for the severely ill – Severe ME/CFS: A Guide to Living –  which can be found at http://www.severeme.info/   I found it disappointing that AYME felt it was necessary to make changes to her book for publication by them.

Her vivid appeal is posted on the ME Association website and I repost it here.

Emily’s Appeal – It has been said that the following is hard to read. But that is all we ask you to do: to read it, to forward/re-post it and to pledge your support for the many thousands of people like Emily who have to LIVE it.

“My name is Emily. I developed the neurological condition Myalgic Encephalomyelitis (ME) when I was 6 years old. In April 2011 I turned 30. I still have ME.

ME coloured every aspect of my childhood; it painfully restricted my teens and it completely destroyed my twenties. Now, as I move into the next decade of my life, I am more crippled than ever by this horrific disease.

My doctors tell me that I have been pushed to the greatest extremes of suffering that illness can ever push a person. I have come very close to dying on more than one occasion. If you met me you may well think I was about to die now – it’s like that every single day. After all these years I still struggle to understand how it’s possible to feel so ill so relentlessly.

My reaction to small exertions and sensory stimulation is extreme. Voices wafting up from downstairs, a brief doctor’s visit, a little light, all can leave me with surging pain, on the verge of vomiting, struggling with each breath and feeling I’ll go mad with the suffering. Of course it can also be as bad as this for no particular reason – and often is. I cannot be washed, cannot raise my head, cannot have company, cannot be lifted from bed, cannot look out of the window, cannot be touched, cannot watch television or listen to music – the list is long. ME has made my body an agonising prison.

My days and nights are filled with restless sleep interspersed with injections, needle changes (for a syringe driver), nappy changes (as well as experiencing transient paralysis and at times being blind and mute, I am doubly incontinent) and medicines/fluid being pumped into my stomach through a tube. My life could be better if I had a Hickman line (line which goes into a major vein and sits in the heart) for IV drugs and fluids, but such a thing would likely kill me. I’m on a huge cocktail of strong medications which help, yet still most days the suffering is incomprehensible. During the worst hours I may go without the extra morphine I need as I feel so ill that the thought of my mother coming near to administer it is intolerable – this despite pain levels so high that I hallucinate.

I live in constant fear of a crisis driving me into hospital; our hospitals have shown such lack of consideration for the special needs of patients like me that time spent in hospital is torture (eased only by the incredible kindness shown by some nurses and doctors) and invariably causes further deterioration.

Many days I feel utter despair.

But, unlike some sufferers, over the long years in which I’ve had severe ME (the illness began mildly and has taken a progressive course) I have at least had periods of respite from the absolute worst of it. During those periods I was still very ill, but it was possible to enjoy something of life. So in these dark days I know there is a real chance of better times ahead and that keeps me going.

My entire future, and the greatly improved health I so long for, however, currently hinges on luck alone. This is wrong. As I lie here, wishing and hoping and simply trying to survive, I (and the thousands like me – severe ME is not rare) should at least have the comfort of knowing that there are many, many well-funded scientists and doctors who are pulling out all the stops in the quest to find a treatment which may restore my health and that the NHS is doing all possible to care for me as I need to be cared for – but I don’t. This wretched, ugly disease is made all the more so through the scandalous lack of research into its most severe form and the lack of necessary, appropriate support for those suffering from it. This is something that must change.

And that is why I tell my story; why I fight my painfully debilitated body to type this out on a smartphone one difficult sentence at a time and to make my appeal to governments, funders, medical experts and others:

Please put an end to the abandonment of people with severe ME and give us all real reason to hope.”

Scott  Jordan Harris, a journalist who also has ME, wrote an article about Emily for the Guardian after her death.   www.guardian.co.uk/commentisfree/2012/mar/30/me-emily-collingridge-chronic-fatigue-syndrome 

Hexham Forum Cinema screening of Voices from the Shadows on Sat 24th November at 5pm. followed by  a Q&A session with Dr Nigel Speight. Admission is free but please ring 01434 601144 after 4.30pm to book a place. This screening has been organised by Margaret Rumney and her daughter Emma who made the posters and adverts.  They are delighted that when they invited their  MP along he agreed to attend.

Dr Nigel Speight is a Consultant Paediatrician from Durham who has been involved with children with ME and their families for many, many years. He is considered to be the most experienced UK paediatrician involved with ME, being the paediatric medical advisor for the ME Association and TYMES Trust as well as the medical advisor for the 25% Group and the Welsh ME charity WAMES. Through his work for The 25% Group he is becoming involved in more and more shocking cases where very seriously ill people are not only not receiving the care they need, but they are suffering at the hands of professionals. Dr Speight was a member of the Chief Medical Officer’s Working Group which produced a Report on ME in 2002  and more recently he was a member of the team which produced the highly respected and specific ‘International Consensus Criteria for ME’ in 2011 (updating the Canadian Consensus Criteria). Most recently he helped with the valuable ‘Myalgic Encephalomyelitis International Consensus Primer for Medical Practitioners’ 2012. The Primer can be downloaded from this site www.hetalternatief.org/ICC%20primer%202012.pdf to give to your doctor to help with more accurate diagnosis and treatment options. Sadly, misdiagnosis is currently widespread and is causing untold suffering both to those with ME and to those wrongly diagnosed with ME when they have other more easily treatable and even curable conditions. The Primer should go a long way to countering the high levels of misunderstanding caused by the NICE Guideline and the  CDC or Oxford descriptions of CFS/ME.

Marj van de Sande – co editor  – “The Myalgic Encephalomyelitis International Consensus Panel is pleased to announce that the International Consensus Primer (ICP) for ME has been completed.  The ICP is a one stop, user-friendly reference that specifically targets primary care physicians and specialists in internal medicine.”

It is available free in PDF format here http://hetalternatief.org/ICC%20primer%202012.pdf  and “can be downloaded, posted on websites, and reprinted, provided people comply with all the conditions listed on the title page,”

“Background: An International Consensus Panel was formed with the purpose of developing criteria and a physicians’ primer for ME based on current knowledge. The 26 member panel, consisting of clinicians, research investigators, teaching faculty, and an independent educator, represent diverse backgrounds, medical specialities and geographical regions. Collectively the members of the panel have diagnosed and/or treated more than 50 000 patients who have ME, have approximately 500 years of both clinical and teaching experience and have authored hundreds of peer-reviewed publications.

Criteria: The International Consensus Criteria (ICC) were published in the Journal of Internal Medicinein 2011.
(http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2796.2011.02428.x/full)

Primer: The (ME-ICP) includes a summary of pathophysiological findings, the ICC, diagnostic and treatment guidelines and appendices. The ICP represents the collective wisdom and experience of the members of the panel gleaned through research and hundreds of thousands of hours of clinical investigations, upon which the ICC and ICP are based. The panel hopes that the ICP will enhance clarity and understanding of ME, consistency of diagnosis and optimal treatment internationally.

The ICP is a not-for-profit educational document that can be downloaded, posted on websites, and reprinted providing people comply with all the conditions listed on the title page.”