House of Lords short debate: Neurological health conditions 11 October 2010

House of Lords short debate: Neurological health conditions 11 October 2010

Shortlink: http://wp.me/p5foE-39S

ME Association report followed by full Hansard transcript

Hansard source (Citation: HL Deb, 11 October 2010, c393)

ME Association News page

http://www.meassociation.org.uk/?p=2381

The Countess of Mar battles again for ME in Lords’ debate – 11 October 2010

In a short debate on neurological health conditions in the House of Lords yesterday, crossbench peer The Countess of Mar had this to say:

My Lords, the noble Baroness, Lady Gardner of Parkes, has chosen an appropriate moment to table this Question and I am grateful to her. I declare an interest, as I have a diagnosis – finally – of organophosphate poisoning leading to autonomic dysfunction. I am a patron of several charities and groups that represent the interests of patients with myalgic encephalomyelitis, also known as ME or CFS, but which I will call by its common abbreviation, ME. I am also chairman of Forward-ME.

Arising from my own illness and the battle that I and others had to get the toxicity of the once ubiquitous organophosphates recognised – a battle that I am sure the Minister well recalls – I became interested in other medical conditions, such as fibromyalgia and Gulf War illnesses, for which there was no diagnosis or treatment, let alone recognition. Foremost among these is ME. ME has been categorised as a neurological condition at least since 1968. It is recognised as such by the World Health Organisation and the United Kingdom Government. However, for all these years, sufferers from this awful debilitating illness have been ignored, derided and mistreated. The soubriquet “yuppie flu”, acquired in the 1970s, has stuck in the minds of the public and, unfortunately, in the minds of far too many members of the medical and allied health professions. Too often I hear statements such as: “Sometimes I felt that the therapist did not appreciate how physical and biological the symptoms are. She said she understood but then suggested that a lot could be cured just by thinking differently. I don’t think she really appreciated how severe the symptoms are, or that when I said I couldn’t do something I really meant that I couldn’t do it. She also talked a lot about needing to get fitter, which I thought completely missed the point”.

Many thousands of peer-reviewed scientific papers from researchers around the world demonstrate that ME is a physical disease which has endocrine, immune and cardiovascular effects, as well as neurological symptoms, albeit with some of the psychological aspects common to many chronic diseases. It is distinct from chronic fatigue which is a symptom of many diseases – depression or cancer, for example. Despite this, there is a school of thought, dominant through the last three decades, that this is a psychosocial behavioural problem, easily dealt with by cognitive behavioural therapy and graded exercise. On many occasions I have spoken about the failure of successive Administrations to recognise ME for what it is: a chronic illness with fluctuating symptoms of unknown or uncertain origin and of variable severity. There are theories that it has its source in a viral or bacterial infection that persists and eventually affects all the major bodily systems. Others think its source may be environmental-caused, for example, by those ubiquitous toxic chemicals such as OPs, which are, incidentally, designed to attack the nervous systems of their target species. The simple answer is that we do not know.

In the UK, funding for research into ME has concentrated on its psychological aspects. There is a school of psychiatry determined to claim the condition for its own, both in the UK and internationally. After many years of working in this sphere, I have observed the means by which any valid arguments for a biological cause are mocked and eventually overwhelmed by the noisier medical opposition. They ignore internationally recognised science on the grounds that it is not scientific. They find every reason to reject small-scale scientific research projects conducted in the UK because they are not representative. Members of their own profession who have a considerable degree of success in treating patients with ME are hounded out of business. By writing numerous papers which, of necessity because there is no one else to do it, are peer reviewed by their colleagues, they appear to have proved that there is no need for further research and that the doctors responsible for diagnosing and treating ME do not need to conduct any more than the basic range of tests on their patients.

The previous Administration did try to help patients with ME. The Chief Medical Officer commissioned a report, published in 2002, on the subject. It recognised that ME is an illness that is as chronic and disabling as MS. It recognised the shortfall in research and in NHS provision, particularly for children. The Chief Medical Officer recommended the setting up of specialist centres to diagnose and treat people with ME – £8.5 million was allocated for the purpose. There developed small pockets of excellence where patients were pleased with the provision. These tended to be fine for patients who were able to get to the centres, usually hospital-based, but for the 25 per cent of patients who are housebound and, worse still, bed-bound, there was little help. Some health authorities were so slow that their projects failed to get off the ground before the funding had dried up; others, based on psychiatric units, were regarded with suspicion by patients. What I am saying is that, because of the way that people have behaved over this illness, patients with ME are not getting access to ancillary helpers in the NHS.

Two later reports, the latest published earlier this year by the All-Party Parliamentary Group on ME, of which I was a member, again highlighted the lack of NHS provision for patients with ME. Both reports stressed the failure of the NHS to provide for children and the severely affected. NICE, in its CFS/ME guidelines, also recognised the variable severity of the illness and the lack of treatments available. It recommends that treatment should be tailored to the patient with the patient’s consent and that allied health professionals such as physiotherapists and psychologists must have knowledge of ME and be experienced.

Current NHS treatments depend upon a multidisciplinary approach. I know from experience that a hospital referral can be very unsatisfactory unless the consultant has an open mind and looks at more than just one “bit” of a patient. All too often when a patient fails to respond to the recommended treatment, he or she is blamed for the failure and a psychiatric referral ensues. There is no passing patients on to people who might be able to help them, such as cognitive behaviour therapists. There are an estimated 250,000 people with ME, most of whom are treated by professionals with very little, if any, understanding of their illness. Since specialist services are inadequate, many patients are left to fall upon their own resources. Some are fortunate, such as the patient who said, “By understanding how I could approach my daily activities in smaller chunks and hence planning for this, including fun activities, I ultimately became stable and could build from there”, or another who said, “One-to-one supervision from a very skilled and experienced therapist kept me on track, pulled me up when I needed it and gave me encouragement. They listened to me, believed in me, reflected my progress to me at times when I couldn’t see it”.

I cannot say how important being listened to and being believed are. I am pleased to see that the coalition intends that patients should have more say in the NHS provision of services. I also see that it is to discuss professional training with the royal colleges. However, until there is a cultural change among health professionals, patients with ME will continue to find it difficult to find help within the NHS. Until the professionals take time to listen to patients and to believe them, they will never develop the skills needed to enable them to help patients along the road to recovery.

I wish I had the solution to the suffering of people with ME. It seems that, no matter how often Ministers and senior officials confirm their acceptance of the seriousness of this condition, nothing will change until the culture both within and outside the NHS changes. I believe that in this particular case the patients, some of whom have experienced illness for decades while others have made excellent recoveries, have a huge amount of knowledge to impart. The Canadian guidelines to diagnosis and treatment of ME have, for reasons that have never been explained, repeatedly been rejected by health professionals and yet they are regarded by patients as providing the best course of action.

May I ask the noble Earl whether the coalition continues to accept that myalgic encephalomyelitis is a neurological illness as categorised by ICD10 G93.3? If he does, will he say how Her Majesty’s Government will ensure that there is sufficient qualified medical and allied professional expertise to treat patients with illnesses such as ME with the effectiveness and dignity they deserve?

The “noble Earl” to whom she was addressing her question in the final paragraph was Earl Howe, who is the Parliamentary Under-Secretary of State for Health. His direct response to the Countess was:

The noble Countess, Lady Mar, asked whether the coalition accepts that CFS/ME is a neurological condition. The Government accept that it is a neurological condition. In many cases, allied health professionals will have a role to play and it goes without saying that all of them should treat patients with respect and dignity, whatever their diagnosis.

The debate was launched by Baroness Gardner of Parkes who discussed the role of allied health professionals in maintaining the health and social well-being of people with long-term neurological conditions. Four other peers made substantive contributions to the debate

————-

Full Hansard transcript

Hansard source (Citation: HL Deb, 11 October 2010, c393)

http://www.publications.parliament.uk/pa/ld201011/ldhansrd/text/101011-0002.htm#10101116000064

11 Oct 2010 : Column 379

Health: Neurological Conditions
Question for Short Debate

6.09 pm

Asked By Baroness Gardner of Parkes

To ask Her Majesty’s Government what is their assessment of the role of allied health professionals in maintaining the health and social well-being of people with long-term neurological conditions.

Baroness Gardner of Parkes: My Lords, the notice of the opportunity for this debate was very short, but the topic is an important one and I am delighted that we are debating it this evening. I thank those who are speaking. I know that in some cases they have had to alter their arrangements to enable them to be here and that many others who also have a particular interest in or knowledge of the subject cannot be here today.

I start by giving noble Lords the Royal College of Physicians’s definition of long-term neurological conditions:

“Long-term neurological conditions (LTNCs) form a diverse set of conditions resulting from injury or disease of the nervous system that will affect an individual for the rest of their lives. They include: sudden onset conditions (eg acquired brain injury of any cause (including stroke), spinal cord injury) intermittent conditions (eg epilepsy) progressive conditions (eg multiple sclerosis (MS), motor neurone disease (MND), Parkinson’s disease (PD) and other neurodegenerative disorders) stable conditions with/without age-related degeneration (eg polio or cerebral palsy). Taken together, LTNCs are more common than most clinicians realise. Some 10 million people in the UK are living with a neurological condition which has a significant impact on their lives, and they make up 19% of hospital admissions”. Continue reading

RiME: Commentary on APPG on ME Inquiry into NHS Service Provision for ME/CFS, March 2010

RiME: Commentary on APPG on ME Inquiry into NHS Service Provision for ME/CFS, March 2010

Shortlink: http://wp.me/p5foE-39y

From Paul Davis RiME Campaigning for Research into Myalgic Encephalomyelitis

16 September 2010

APPG on ME Inquiry into NHS Service Provision for ME/CFS March 2010

There is a link to the full Report on the RiME Website, see NHS Services Inquiry folder.

The Report was signed by five members of the APPG on ME: Des Turner MP (Chair), Tony Wright MP, Andrew Stunell MP, Peter Luff MP, Lady Mar.

Note: The Committee on Standards in Public Life promotes, ‘high standards in the public sphere through the seven principles… ‘: they include: objectivity and honesty. Have these criteria been met?

Paul Davis paul641@talktalk.net   www.rime.me.uk

RiME Condemns APPG Inquiry Report

Problems re. Nomenclature and Classification

In the Foreward P.3 Des Turner writes, ‘… The APPG accepts the WHO Classification of ME (ICD G93.3) as a neurological condition… ‘ However, if one flicks to the back of the Report, 14 out of the 24 sources refer to Government Reports (1), with the Royal College of GP’s Report, connected to CMO Report and NICE Guidelines, being used seven times; sources which are not about the illness described by G93.3. The Inquiry Group also received evidence from PCTs: but ME patients complain that clinics set up following the CMO Report are not about ME; the clinics in Kent, for example, exclude patients with neurological illness; so, is the evidence from PCTs accurate or relevant as far as ME is concerned?

The Terms of Reference say (P. 21):

ME is classified as a neurological illness under the World Health Organisation classification (ICD G93.3). However the NHS largely uses the term Chronic Fatigue Syndrome instead of ME or else adopts the hybrid CFS/ME in diagnosing and treating patients. Terminology is a contentious matter. It has some bearing on this inquiry because to only use the precise WHO classification of ME above will impede access to information from the NHS that is crucial to the success of this inquiry…

Continue reading

Text version: Review of Invest in ME proposal for a ‘Centre of Excellence for ME’ in Norfolk

Text version of Review of the Invest in ME proposal for a ‘Centre of Excellence for ME’ in Norfolk by Chris Douglas

Shortlink to this posting: http://wp.me/p5foE-34M

or http://tinyurl.com/ReviewIiMEProposalText

For the Word file of this document and related information go here:

Review of the Invest in ME proposal for a ‘Centre of Excellence for ME’ in Norfolk

 

TEXT VERSION

Review of the Invest in ME proposal for a ‘Centre of Excellence for ME’ in Norfolk

By Chris Douglas

27 August 2010

Introduction

In August 2010, Invest in ME (IiME) published a document titled: ‘A New Era in ME/CFS Research: An Opportunity for Major Progress in Diagnosis, Treatment and Research into Myalgic Encephalomyelitis’¹.

It is assumed that this document is a precursor to a more formal and detailed proposal that will be used to secure consultative input and financial commitment to the project.

The following review highlights specific areas in which the proposal could be strengthened if, in particular, it is to maximise commitment from potential financial donors.

1. Scope
2. Objectives
3. Service Provision Model
4. Funding
5. Conflicts of Interest

1. Scope

1.1. Geographic Scope

The scope of a proposal has direct bearing on project objectives and methodology and provides a framework within which the project can be assessed.

In the current proposal, it is unclear whether the Centre is aimed at servicing the Norfolk region only or the UK as a whole (which, presumably, would include Scotland and Northern Ireland). For example, there is reference to a “national centre of excellence for ME” whilst also discussing East Anglia as being a ‘region of opportunity’.

In particular, it is unclear whether there is a distinction in national and regional service provision between the separate clinical and research facilities detailed in the proposal (and located in Norfolk and Norwich University Hospitals, and the University of East Anglia/Norwich Research Park respectively).

If the clinical service is intended to be national, the following questions arise.

Why has Norwich been selected as a location (given that it has poor logistical accessibility for the rest of the country)?
Have other geographic locations and facilities been considered?
If so, how has their suitability been assessed and by whom?

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For both a national and regional remit, the following questions arise for the clinical service.

Why have Norfolk and Norwich University Hospitals (N&NUH) been selected to host the Centre’s clinical facility?
What specific types and levels of expertise would N&NUH bring to the Centre?
Does N&NUH health care staff have the capabilities and infrastructure to deliver the proposed service and, if not, how would this be addressed?
Have other facilities been considered?
If so, how has their suitability been assessed and by whom?

For a national and/or regional remit, the following questions arise for the research service.

What is the rationale for selecting the University of East Anglia/Norwich Research Park (UEA/NRP) to run the Centre’s research programme?
Has the UEA/NRP submitted a formal proposal for hosting the research programme?
If so, who has assessed this and how has it been assessed?
Have other research facilities been asked to submit proposals?
If so, who has assessed these and how have they been assessed?

The distinction between a national and regional service is further confused by the assumption that the Centre’s ‘translational’ model can be achieved only where the clinical and research services share the same geographic location.

The rationale for this assumption is unclear and, indeed, is contrary to the existing health care provision framework in the UK which operates through a countrywide network of medical facilities within (or co-ordinated by) the National Health Service (NHS).

1.2. Disease Scope

The document uses the nomenclature ‘ME’ (myalgic encephalomyelitis) to describe the condition that it intends to cover although there are further associated illnesses that overlap with ME and, indeed, may actually be the same disease (e.g. fibromyalgia, atypical MS, atypical lupus).

In addition, the UK medical profession uses other terms to describe ME, including Post Viral Fatigue Syndrome (PVFS), Chronic Fatigue Syndrome (CFS) and even just chronic fatigue.

The UK medical profession also lacks clarity and consistency in disease definition and diagnosis, an issue which, as pointed out in the proposal, can lead to patients being diagnosed incorrectly (either as having ME when they do not or not having ME when they do).

To avoid the considerable confusion and inaccuracy of existing nomenclature, definition and diagnosis, it may be preferable to adopt the term ‘neuroimmune disease’, as used by the US Whittemore Peterson Institute (WPI) which the proposal states is a role model for the Centre.

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This may also avoid the potential confusion between the Centre of Excellence and existing NHS ME/CFS Centres (referred to in the proposal) which attract criticism for, amongst other things, their lack of biomedical intervention and focus on occupational and behavioural therapies.

In addition, this would provide a platform for further research into the human gammaretrovirus (HGRV) family which has been linked with ME and is the current focus of the WPI. The current proposal does not make reference to this retrovirus and this would seem an oversight given (a) the growing scientific interest in this area and (b) that donors to IiME’s Biomedical Research Fund approved support of the WPI’s UK study of HGRVs. It is also highly relevant for diagnostic purposes (a key focus of the proposal) given the likelihood that HGRVs will become, at very least, a biomarker for ME.

2. Objectives

Successful projects are underpinned by objectives which are specific, quantified, achievable and measurable.

The current proposal omits specific, quantified objectives or project ‘deliverables’, possibly because these are difficult to define given the lack of a precise scope.

Once the scope has been clarified, it may help to establish an overarching mission, a set of objectives and a timeline for implementation.

Given that this is a start-up project with a limited budget (see 4. Funding), it may be prudent to begin with a limited remit that can be met within a short lead-time and then used as a basis from which to develop more ambitious plans.

An example clinical mission would be: ‘To translate international biomedical research findings and therapies into clinical treatments for patients in Norfolk.’

Clinical objectives could include:

– to diagnose and treat x number of patients over time period y
– to deliver xx% improvement in patient health and well-being over time period y
– to train x number of N&NUH doctors in the diagnosis and treatment of ME over time period y

An example research mission would be: ‘To implement research programmes that complement and support those of the WPI.’

Research objectives could include:

– to complete x number of studies (by specified type) over time period y
– to replicate/validate findings of research study z
– to test the efficacy of treatments a, b and c over time period y

The proposal lists eleven project benefits and certain of these could be classed as deliverables (e.g. domiciliary services) but would require greater detail based on a

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quantified top line objective (e.g. diagnosis and treatment of a specified number of housebound patients pa).

All objectives would require an accompanying plan for delivery and methods of measurement and assessment.

3. Service Provision Model

In the absence of specific and robust objectives to use as a benchmark, it is difficult to assess the potential outcome efficacy of the proposed service model although questions about operational efficiency can be raised at this stage.

The diagram in figure 1 is a graphic representation of the service provision model described in the proposal. The shaded organisations are those which, combined, form the Centre of Excellence.

Fig 1. Overview of assumed service provision model

The proposal describes this as a “simple but effective structure”, although it could be argued that the model is, actually, quite complex given the number of stakeholders and communication pathways that are involved.

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In addition, four separate organisations and geographic locations constitute the Centre of Excellence itself, which makes it a concept rather than a single entity, and so conflicts with the proposal’s underlying theme of a closely integrated operation.

The responsibilities of each of the organisations within the Centre are unclear from the proposal, as are how they will inter-relate and how communication and control will be managed.

In particular, the proposal requires more detailed explanation of the roles of Norfolk PCT and N&NUH, not only in terms of how they may provide patient services regionally and/or nationally, but also in terms of their potential model for other PCTs and hospital trusts to follow, as well as their operation within the NICE (National Institute for Health and Clinical Excellence) guidelines for treating ME.

The proposal states that “a new commissioning director at Norfolk PCT…is supporting the steering group’s views”. It would be helpful to name the individual in question and also include their input in detail.

The position of a ‘clinical biomedical lead consultant’ is mentioned and also that candidates have been approached for this role, although their remit and responsibilities, selection and measurement criteria, and reporting structure are not explained. Similarly, it is unclear how the ‘GPs with special interest’ who support the lead consultant will be identified, enrolled, trained and funded.

The proposal recognises the critical importance of training health care staff (and also mentions ‘visiting experts’) although it is unclear who will be responsible for training the N&NUH staff, which staff will be trained and how training will be implemented and monitored.

Staff training will be paramount to the Centre’s success, particularly given the NHS’ current dearth of biomedical knowledge about ME and its inappropriate and, sometimes, harmful treatment options for the disease (as per the NICE guidelines, mentioned above). IiME needs to demonstrate that the NHS’ long established and entrenched misunderstanding of ME can be corrected, and swiftly, if the Centre is to gain the confidence of patients and commitment of financial donors.

With specific reference to IiME’s involvement in the project, the proposal would benefit from more detailed explanation of the following.

For each of the three IiME entities (charity, limited company and steering group):

– role
– management structure
– governance
– overlap with the other two entities

For the charity and steering group specifically:

– members and/or trustees (other than the two named in the proposal)
– how members/trustees are appointed
– who appoints members/trustees
– to whom members/trustees are accountable
– how members/trustees are monitored

Page 6

For IiME Ltd specifically:

– when the company was/will be incorporated
– business classification and trading objectives
– share structure and ownership
– board members and responsibilities
– relationship with Norfolk PCT and N&NUH (given that the proposal refers to IiME Ltd supporting service commission by the former from the latter)

In addition, it would be helpful to understand how the Centre’s work might be integrated with that of other ME research organisations such as ME Research UK (currently funding a HGRV study in Sweden), the UK CFS Research Foundation (supporter of Dr Jonathon Kerr’s research for many years), as well as with its stated role model, the US WPI.

4. Funding

The proposal omits a top line funding requirement, a budget break-down and a cost-benefit analysis for the project.

Norwich local newspaper, EDP24, has stated: “Discussions will be going on over the next few months and once a decision has been made, funding will begin to the tune of £150,000 a year.”²

This amount seems low in the context of the proposed service provision model and particularly in comparison to the Center for Molecular Medicine (home of the WPI at the University of Nevada) which cost $77 million to establish.

The proposal states that funding for research would be “organised and provided by the charity and the UEA” although there is no further detail of how this would be supported nor who would fund the clinical element.

As a consequence, the following information remains to be confirmed.

The estimated cost (overall and breakdown) of establishing and maintaining the Centre over a given time period (for example, five years).

The share and source of funding to be provided by each of the organisations involved in the Centre.

How the funds will be raised by each of the contributing organisations.

Methods for monitoring expenditure, measuring outcomes and reporting to fund contributors.

For those funds raised via IiME (the charity), whether donors will contribute to the Centre as a whole or to specific research and/or clinical projects.

For IiME (the charity), the share of funding to be sourced via the following:

– general donations to the charity;
– profits from sale of IiME’s annual conference DVD;

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– donations to IiME’s Biomedical Research Fund;
– donations to a separate Centre specific fund.

•  Whether, after completion of the WPI’s UK study, any residual monies in IiME’s Biomedical Research Fund will be transferred to the Centre or remain in the Fund for further research projects, and whether donors’ approval will be sought for either course of action (as per the precedent set when monies were reallocated from Dr Kerr’s withdrawn research to the WPI’s UK study).

5. Conflicts of Interest

Fund donors may wish to see further explanation for, and clarification of, the following potential conflicts of interest.

Dr Ian Gibson’s involvement in this project will raise concerns with those who did not welcome his unofficial ‘Gibson Inquiry’ into ME (as referenced in the proposal) and the subsequent uncorrected ‘e-report’ which was published in October 2006³. There were significant criticisms of the way that Dr Gibson and his panel undertook this inquiry (which was a personal project and not a formal Parliamentary Inquiry or Report), such as the involvement of Lord Turnberg, a known supporter of cognitive behavioural therapy (CBT) and graded exercise therapy (GET), and the absence of proper consultation with the inquiry’s constituency of interest at all stages throughout the life of the project. Previously a Labour backbencher, Dr Gibson was barred from standing for the party in the 2010 general election following questions about his ministerial expenses.

Dr Fiona Poland of UEA’s Institute of Health and Social Science Research is working in partnership with Action for ME (AfME) and a network of universities on part of a major ME research project sponsored by the Big Lottery Fund (i.e. reporting and developing early findings on the impact of the illness and available means of support). The association between UEA and AfME will raise concerns with a growing number of patients who openly criticise the latter’s role, agenda and efficacy, particularly in terms of its apparent unwillingness to support biomedical ME research and to challenge the psychosocial paradigm.

The Norwich Research Park is a joint venture between the UEA, and amongst others, the Sainsbury Laboratory which, in turn, is supported by the UEA and the Gatsby Foundation. The Gatsby Foundation is one of a number of Sainsbury Family Charitable Trusts which share the same administrators and counsels. This includes the Linbury and Ashden Trusts which have provided funding for the RNHRD NHS FT, Bath (the ‘Min’) and the University of Bristol’s controversial trial of the Lightning Process on children and for which IiME has stated its public opposition.

The Institute for Food Research (IFR) and The Genome Analysis Centre (TGAC) are institutes of the Biotechnology and Biological Sciences Research Council (BBSRC). The BBSRC grant-aids the John Innes Centre (based in Norwich Research Park) which hosts the Sainsbury Laboratory and the TGAC. BBSRC is one of seven Research Councils that work together as Research Councils UK (RCUK). It is funded from the Government’s Department for Business, Innovation

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and Skills (BIS). This is a complex organisational structure which makes it difficult to achieve transparency in funding governance and also to identify potential conflicts of interest.

It is unclear from the proposal whether ME support groups in the Norfolk region (or nationally, if the scope is such) are involved in this project and the degree to which they have provided input and support. It is also unclear whether there has been any wide-scale patient consultation for this project or if any is planned in the future.

References

1 Invest in ME proposal for a ‘Centre of Excellence for ME’ in Norfolk August 2010
‘A New Era in ME/CFS Research: An Opportunity for Major Progress in Diagnosis, Treatment and Research into Myalgic Encephalomyelitis’

2 EDP24 “Norwich centre for ME sufferers planned” 03.08.10

3 THE ONE CLICK GROUP REPORT THE GIBSON ‘INQUIRY’ 17 January 2007

 

Chris Douglas is an ME sufferer and ex-corporate project manager.

douglas_chris@hotmail.co.uk

© Chris Douglas 2010

Review of Invest in ME proposal for a ‘Centre of Excellence for ME’ in Norfolk

Review of the Invest in ME proposal for a ‘Centre of Excellence for ME’ in Norfolk by Chris Douglas

Shortlink to this posting: http://wp.me/p5foE-33z

or http://tinyurl.com/ReviewIiMEProposal

At the 5th Invest in ME International ME/CFS Conference held in May, this year, a proposal was announced for the establishing of a “Centre of Excellence for ME” in Norfolk. To the best of my knowledge, Invest in ME had undertaken no national consultation with ME patients before drawing up its proposals.

Today I am publishing a review of Invest in ME’s proposal prepared by Chris Douglas.

A text version of this review is published in the next post.

 

Review of the Invest in ME proposal for a ‘Centre of Excellence for ME’ in Norfolk

By Chris Douglas

27 August 2010

Introduction

In August 2010, Invest in ME (IiME) published a document titled: ‘A New Era in ME/CFS Research: An Opportunity for Major Progress in Diagnosis, Treatment and Research into Myalgic Encephalomyelitis’¹.

It is assumed that this document is a precursor to a more formal and detailed proposal that will be used to secure consultative input and financial commitment to the project.

The following review highlights specific areas in which the proposal could be strengthened if, in particular, it is to maximise commitment from potential financial donors.

Review of the Invest in ME proposal for a ‘Centre of Excellence for ME’ in Norfolk

Open Word document here: Norfolk Proposal Review 27.08.10

A text version of this Word document is published in the next post

 

Related information

Invest in ME

“Invest in ME is an independent UK charity campaigning for bio-medical research into Myalgic Encephalomyelitis (M.E.), as defined by WHO-ICD-10-G93.3.”

Invest in ME is constituted as a Trust, registered with the Charity Commission and run by a committee of three Trustees/Directors. Invest in ME is not a membership organisation. The organisation was founded in 2006 by carers and patients, Sue Waddle, Richard Simpson and Kathleen McCall (current chair). Ms Waddle has since stood down as a Trustee.

http://www.investinme.org/Research%20-%20ME%20Institute.htm

Invest in ME

A UK Centre for Biomedical Research into ME

Read the announcement here

The Research Proposal published by Invest in ME in July can be read here in PDF format:

       Biomedical Research Institute Proposal July 2010

“A New Era in ME/CFS Research 

“An Opportunity for Major Progress in Diagnosis, Treatment and Research into Myalgic Encephalomyelitis”

“A VISION FOR THE FUTURE

“Recent biomedical research and advances in knowledge and treatment regarding Myalgic Encephalomyelitis have brought more urgently needed awareness of this disease. In the East Anglian region of UK an opportunity now exists to bring real benefit to patients and establish a unique capability which will attract attention and recognition from across UK and Europe.”

 

Media coverage

Great Yarmouth Mercury

Hopes for ME centre in Norfolk raised

31 August 2010

“…The independent charity will carry out the official campaigning for funding for the centre once a formal agreement is made.

“Now the charity has offered to send some of the UEA researchers to a biomedical research symposium in Australia at the end of the year.

“Mr Simpson said: “This would involve them discussing work with the top ME researchers and clinicians in this field from around the world.

“Discussions are under way, and we are really hopeful this will move things forward. The centre could change the lives of patients with ME. Early diagnosis is so important, and this centre would help establish that.’

“The charity is also planning to organise a conference in Norwich with the UEA and the Norfolk and Norwich University Hospital and is lining up discussions with the US Whittemore Peterson Institute, an institute for neuro-immune disease in Nevada that helps thousands of people with ME through research, scientific developments and treatment…”

———————

Norwich Evening News

Plans for world class Norfolk centre

Sarah Hall  |  27 August 2010

———————

Environmental Illness Resource Blog

UK to get WPI Inspired Chronic Fatigue Syndrome Research and Treatment Centre

News – Chronic Fatigue Syndrome News

Matthew Hogg  |  13 August 2010

———————

EDP24

Norwich centre for ME sufferers planned

Sarah Hall  |  3 August 2010

ME Association Summary and Statement on Lo et al paper

ME ASSOCIATION SUMMARY AND STATEMENT ON LO et al PAPER:

Detection of MLV-related virus gene sequences in blood of patients with chronic fatigue syndrome and healthy blood donors

Shortlink: http://wp.me/p5foE-33G

Issued 25 August 2010

ME ASSOCIATION SUMMARY AND STATEMENT ON LO et al PAPER:

Detection of MLV-related virus gene sequences in blood of patients with chronic fatigue syndrome and healthy blood donors

Authors: Shyh-Ching Lo (US Food and Drug Administration) et al.

Published in the Proceedings of the National Academy of Sciences (PNAS) on August 23rd 2010.

Pdf available on-line: http://www.pnas.org/content/early/2010/08/16/1006901107.full.pdf+html

Accompanying commentary by Valerie Courgnaud et al: http://www.pnas.org/content/early/2010/08/16/1007944107.full.pdf+html

BACKGROUND:

Murine leukaemia viruses (MLV) are retroviruses known to cause cancer in certain mice. In 2006, investigators found that a type of MLV, called xenotropic murine leukaemia virus-related virus (XMRV), could potentially infect humans after finding it in tissue samples from men with prostate cancer. XMRV is one of a number of MLVs that appear to be transmitted to humans.

In October 2009, Lombardi et al published the results of study in Science which contained evidence that XMRV was present in a high percentage (67%) of people with ME/CFS and in a small percentage of healthy controls.

Since then there has been a great deal of interest from researchers in a number of countries where ME/CFS is recognised. A number of research groups have attempted (or are still attempting) to repeat these positive XMRV findings.

Confirming or refuting new findings is a vital part of the scientific evaluation process and involves other independent research groups trying to either replicate or validate the results.

In relation to XMRV, a true replication study should involve exactly the same laboratory methods and same type of patients that were used in the original Science study. A validation study gives scientists a degree of flexibility. In particular, it provides the opportunity for other research groups to try and repeat the findings using what they feel are the most sensitive and accurate laboratory methods they have access to for testing for XMRV.

In the case of XMRV almost all of the first wave of research has involved validation studies. Firstly, because there is no international agreement about the most accurate and sensitive way of detecting XMRV in blood samples. Secondly, because these research groups all wanted to move quickly, and the easiest way to do so was to use stored blood samples from people who had been diagnosed with CFS in the past according to Fukuda research criteria. Stored blood samples from people who met both Fukuda and Canadian criteria (which were used in the original study) are not readily available.

Results from four emphatically negative validation studies of varying quality – three carried out in Europe and one carried out by the CDC in America – have now been published in scientific journals. Results from a further (so far unpublished) study, carried out by Professor Brigette Huber, were presented at the Invest in ME conference in May 2010 (report available on MEA website and in the August 2010 of ME Essential).

None of these five research groups – which in the case of the UK included Professor John Gow, Dr Kate Bishop, Dr Jonathan Kerr and Dr Jonathan Stoye and used patient samples supplied by physicians and neurologists including Dr Abhijit Chaudhuri and Professor Peter Behan – have been able to find evidence of XMRV in blood samples from ME/CFS patients, or in the healthy controls.

Although some very valid criticisms have been made about all of the XMRV negative studies, in particular the most recently reported one from America, a number of distinguished virologists who work with retroviruses and XMRV have been involved – so these XMRV negative results have to be taken seriously as well.

THE LO et al STUDY

On 23 August 2010 the results from the first follow up study to firmly support a link between a retroviral infection and ME/CFS were published.

This study is clearly an important contribution to the XMRV debate in that it fully supports a link between ME/CFS and retroviral infection. In this respect it also supports the findings in the Lombardi paper.

However, it is not a true replication study, and in the words of the authors they have not attempted to fully replicate the Lombardi et al findings.

Lo et al have used different laboratory methods and different patient criteria and their findings relate to what are called MLV-related viruses.

The research group have found segments of genetic material (not whole virus) from what they term a genetically diverse group of MLV-related viruses. These sequences are more closely related to those of polytropic mouse endogenous (=arising within or derived from the body) retroviruses than to those of XMRVs – hence the use of the term MLV (murine = mouse leukaemia virus) in the title. But they all belong to a closely related family of retroviruses.

PATIENT SELECTION

In contrast to the Lombardi et al study, which involved patients who met both Fukuda research criteria and Canadian Clinical Criteria for CFS, this research used stored blood samples from ME/CFS patients who had been diagnosed using either the 1988 Holmes research criteria or the 1994 Fukuda research criteria. The patients were diagnosed with CFS from the mid 1990s onwards and most of the frozen blood samples were supplied by Professor Tony Komaroff at Harvard Medical School, Boston. Professor Tony Komaroff is a well respected physician with a longstanding interest in ME/CFS. In addition, 12 patient samples came from other US physicians whose diagnostic criteria for ME/CFS is not stated.

The numbers involved were surprisingly small for a study of this nature: 37 patients with CFS and 44 healthy controls.

The healthy control samples came from Washington DC blood donors recruited between 2003 and 2006.

So these results apply to a rather broader group of ME/CFS patients than was used in the Lombardi et al study and the patient sample is probably very similar to at least one of the other validation studies that produced negative findings in relation to XMRV. As with some of the other validation studies, it is highly likely that a significant number of people who also meet Canadian Clinical Criteria will have been included in this study.

RESULTS

MLV-like virus gag gene sequences (in simple terms segments of viral genetic material) were found in 32 out of 37 (86.5%) of the ME/CFS patients compared to only 3 out of 44 (6.8%) of the (blood donor) healthy controls.

Follow-up samples were collected from 8 of the CFS patients in 2010, and 7 of these again tested positive for MLV-like gene sequences.

As already pointed out, the evidence in this paper relates to a genetically diverse group of MLV- related viruses with gene sequences that are more closely related to those of polytropic mouse endogenous retroviruses (mERVs) than to those of XMRV. XMRV is a genetic variant of MLV-like viruses – so this is a subtle but relevant distinction.

The authors point out that they have taken exhaustive steps to try and ensure that they have not produced false positive results as a result of mouse DNA contamination, or any of the other potential laboratory problems that come when working with retroviral infections.

CORRELATION, INFECTION AND POSSIBLE CAUSATION

The authors point out (p5) that the finding of XMRV or MLV genetic sequences in people with ME/CFS, or any other disease, does not constitute definite proof of viral infection.

They then go on to make it clear that further research will be required before any definite conclusion can be drawn as to whether MLV-related viruses play a role in the causation of ME/CFS. This is a process that is going to take time and further research.

They also state (p6), as has been pointed out in previous MEA summaries on XMRV, that a high frequency of MLV-related viruses (or XMRV) in ME/CFS patients could reflect an increased susceptibility to viral infections due to the underlying immune dysfunction found in ME/CFS rather than a primary disease causing role in the pathogenesis of ME/CFS. In other words the retrovirus could just be there as a ‘harmless passenger’.

COMMERCIAL TESTING FOR MCVs and XMRV

The MEA continues to believe that there is no point in spending very large sums of money on arranging blood tests, which may not have been properly validated, for XMRV (or MCVs) outside the UK. Having a positive result is not, in our present state of knowledge, a diagnostic marker for ME/CFS. Equally, having a negative result does not mean that you do not have ME/CFS. Having a positive result will not affect ME/CFS management at present and if this information is inserted into medical records it could in due course cause problems with other health matters such as applications for insurance policies or travel abroad.

The way in which these viruses might be transmitted from person to person also remains uncertain and sexual transmission is one possibility – as in the case of HIV. However, if this is a disease causing virus like HIV, sexual transmission appears very unlikely given the fact that ME/CFS appears to be very rare in sexual partners of people with ME/CFS, even after long periods of time.

BLOOD DONATION

The MEA continues to believe that the current uncertainty over transmission of these viruses/viral segments means that people with a current or past history of ME/CFS should not be donating blood and we have recently written to the acting Chief Medical Officer at the Department of Health to seek clarification on what appears to be a recent decision to extend the UK ban to people who have recovered from ME/CFS. Copy of this correspondence [here]

We find it surprising that the American authorities responsible for blood safety have not followed the UK lead here.

ANTIVIRAL TREATMENT

The authors of this paper make no comment or recommendations regarding the use of antiviral drugs. However, others (including the authors of the accompanying commentary) are now suggesting that it is time to assess the use of antiretroviral therapy (ART) in ME/CFS in some clinical trials. It is well accepted that one way of examining the possible cause of a disease is to assess the response to specific forms of treatment.

The MEA has already pointed out on several occasions that this type of clinical trial would have to proceed with great care given the fact that ARTs can have serious side-effects. In the case of AZT, this drug can cause mitochondrial damage – which is obviously very relevant in ME/CFS. But there are other ARTs becoming available that appear to be active against XMRV and may be much safer to use (eg reverse-transcriptase inhibitors such as tenofovir and emtracitabine).

We have also pointed out that ARTs appear to have very limited effect in reducing fatigue in HIV/AIDS, and that this may be due to the immune system activation that is occurring in this situation rather than any direct effect on reducing the viral load of the HIV infection. So drugs that dampen down immune activity (eg a tumour necrosis factor inhibitor such as etanercept) may be a more appropriate route to follow. More information [here]

In the UK doctors are very unlikely to be willing to prescribe any type of antiviral treatment on an individual (ie non research) basis. This is because the 2007 NICE guideline on ME/CFS specifically recommends that antiviral drugs should not be used to treat ME/CFS. And if anything goes wrong through the use of a potentially toxic antiviral drug, that is in effect banned by NICE, and has not been assessed in a proper clinical trial, the doctor responsible could face legal action even though the patient accepted the risk.

FURTHER RESEARCH AND THE ROLE OF MEA RAMSAY RESEARCH FUND

Investigators at FDA, NIH, CDC and other scientific institutions are in the process of conducting studies to verify the capabilities of the tests used by the different laboratories for the detection of XMRV or MLV-related viruses in blood. These studies are intended to develop and standardise a highly sensitive and specific XMRV test to better study its association with disease, as well as the possibility that XMRV can be transmitted to blood or tissue recipients.

The UK Medical Research Council’s Expert Group on ME/CFS research (of which CS is a member) has identified all aspects of viral infection in ME/CFS (including carefully targeted use of antiviral agents) as a priority item for further UK research and we expect that this recommendation will now be translated into action.

The MEA is again making it clear to UK research groups with expertise in retrovirology, and access to reliable patient samples, that we would very much welcome good quality research applications relating to any aspect of XMRV or MLVs. The MEA is also willing to consider co-funding research applications in this area.

We are in contact with most of the key UK researchers working on XMRV and we are also assisting with a small UK study that is intending to retest people who already have a positive XMRV result as a result of having this test done in America.

We also need to find out how common these new retroviruses are in people with other chronic disabling conditions, especially those that involve immune system dysfunction.

MEDIA REACTION

In America, the paper has been quite widely reported with most of the coverage being supportive. In the UK there has been very little interest in the press release – apart from the Daily Mail (which carried an on-line story) and the New Scientist:

http://www.newscientist.com/article/dn19361-virus-link-with-chronic-fatigue-syndrome-resurfaces.html  

which includes quotes from Professor Myra McClure, one of the UK virologists involved in a negative validation study.

Lack of coverage in the UK is partly because selected health journalists, who might have reported the story, like to have access to a new research paper well before the information enters the public domain – so they have a day or two to chase around and obtain informed comment on the story. Health reporters have finished writing their copy for the next days paper well before 8pm in the evening – so unless there is a real breakthrough news item they are not at their desks in the evening. The US press conference at 8pm UK time did not fit in with their working arrangements for printing something on Tuesday and the findings would be ‘old news’ by Wednesday. In addition, they also had a good headline health scare story for Tuesday morning relating to people being refused an anti-cancer drug due to a NICE ruling.

Unfortunately, there are health correspondents that I speak to on the more influential papers and journals who are now very cautious about covering ME/CFS stories.

OVERALL CONCLUSIONS

In very simple terms the clinical and scientific community regards published papers rather like goals (of varying quality) in a football match. So the current score is XMRV and MLV positive 2 (with a spectacular first goal!): XMRV negative 4 (of varying quality) with plenty of time left before the final score.

The comments so far that I have read, or been given, by experts in this area of virology indicate that everything has been done correctly in this study and that this is a sound piece of laboratory research. However, with differing results from differing well respected retroviral laboratories, the clinical and scientific community is likely remain uncertain or sceptical about the link between retroviral infection and ME/CFS.

Another analogy is fitting pieces into a jigsaw puzzle with a lot of blue sky. We now have six pieces (ie published papers of varying quality) in place and some strong opinions on either side. But a lot of pieces have still to be fitted into the picture.

Overall, there is no sign of any real scientific consensus emerging as to whether XMRV and/or MLVs are playing a significant role in ME/CFS and many key questions regarding prevalence, transmission and pathogenesis remain unanswered. Things may become a bit clearer as a result on the international meeting on XMRV in September, which will include a session on ME/CFS. Proposals for further research may also emerge after this meeting.

This uncertainty and scientific disagreement seems likely to continue until well into 2011 and the current findings are unlikely to have any significant influence on the forthcoming review of the NICE guideline or the increasingly difficult position faced by people with ME/CFS in relation to sickness and disability benefits. [Our most recent correspondence on 24 August from NICE indicates that they have still to decide on the date at which the review will take place, whether it will be a full review – which could take up to a year, or whether they might delay the review to await the results of further research from clinical trials.

More top quality research is clearly needed here in the UK and the MEA is very willing to consider funding it.

ADDITIONAL INFORMATION FROM US FDA:

FDA Question and Answer on the paper: http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm223232.htm

Answers to the final three questions, which are of importance to US readers:

9. Does FDA agree with the AABB recommendation to discourage donation by people with history of CFS?

FDA does not object to the AABB recommendation. The AABB recommendation is consistent with a long-standing position of the Chronic Fatigue and Immune Dysfunction Syndrome (CFIDS) Association of America that individuals with CFS voluntarily should not donate blood.

10. How are the differences between the CDC and FDA study results being evaluated?

Differences in the results could reflect differences in the patient populations that provided the samples. Alternatively, undefined differences in the method of sample preparation could be contributing to the discordant test results. All of the scientists involved are working collaboratively to design experiments to quickly answer this scientifically puzzling question. An independent investigator at the National Heart, Lung, and Blood Institute (NHLBI) set up a test set of 36 samples, including known positives and presumed negatives. Both the FDA/NIH and CDC labs participated in this test, and the results showed that both labs were able to detect XMRV present at low levels in blinded samples. Additionally, the CDC laboratory provided 82 samples from their published negative study to FDA, who tested the samples blindly. Initial analysis shows that the FDA test results are generally consistent with CDC, with no XMRV-positive results in the CFS samples CDC provided (34 samples were tested, 31 were negative, 3 were indeterminate).

11. What do these findings mean to CFS patients and clinicians who treat them?

Although this study found MLV-like viral gene sequences in a high percentage of CFS patients, this does not prove that these retroviruses are the cause of CFS or of any other disease. Moreover, other studies have not found evidence of such retroviruses in patients with CFS. Further studies are necessary to determine if XMRV or other MLV-like viruses are reproducibly associated with CFS, and if so whether the virus is a causative agent or a harmless co-traveler. The different findings from various studies reinforce the need for more research–including careful analysis of other cohorts of CFS patients from different geographic regions, studies of larger populations of healthy people, and testing of transmissibility of the agents through blood transfusions in animal models. FDA, NIH, and CDC have and will continue to collaborate with other agencies and groups involved in this research.

Summary prepared by Dr Charles Shepherd
Hon Medical Adviser, MEA

MEA website: http://www.meassociation.org.uk

NB: There will be a delay in placing this item on the MEA website because our webmaster is away on holiday for the next few days.

25 August 2010

ENDS

Study: Presence of Murine Leukemia Virus Related Gene Sequences Found in CFS Patients

Study: Presence of Murine Leukemia Virus Related Gene Sequences Found in CFS Patients finally published

Shortlink: http://wp.me/p5foE-31Z

Discussion thread on Phoenix Rising Forums:

http://www.forums.aboutmecfs.org/showthread.php?7072-Dr.-Alter-Paper-embargo-ends-today-at-3-00pm-press-conference-today/

Media

http://health.msn.com/health-topics/articlepage.aspx?cp-documentid=100262656

More Evidence Virus Plays Role in Chronic Fatigue Syndrome
Condition afflicts a million Americans, but cause, treatments remain elusive
By Jenifer Goodwin HealthDay Reporter

The Scientist

Q&A: Why I delayed XMRV paper, The Scientist – Magazine of the Life Sciences

http://www.the-scientist.com/blog/display/57628/

Wall Street Journal

http://online.wsj.com/article/SB10001424052748703846604575447744076968322.html?mod=googlenews_wsj

Dr Judy Mikovitz on paper on YouTube:

http://www.youtube.com/watch?v=9ZEwQUg7o6I&feature=channel 

CFS Central Blog by Mindy Kitei

http://www.cfscentral.com/2010/08/fdanihharvard-xmrv-study-same-thing.html

The just-released study detects variants of the retrovirus XMRV in most CFS patients. In addition, nearly 7 percent of the healthy U.S. controls—all of whom are blood donors—test positive, signaling the contamination of the U.S. blood supply…

…the authors state that their conclusions “clearly support” the October 2009 Science paper linking a retrovirus to the neuroimmune disease Chronic Fatigue Syndrome (CFS), which afflicts 17 million people worldwide…

…Most surprising is that the PNAS study didn’t find XMRV, which stands for Xenotropic Murine Leukemia Virus-Related Virus, in any patients or controls. Instead, the researchers—from the National Institutes of Health (NIH), the FDA and Harvard Medical School—detected novel close cousins to XMRV called MLVs—which stands for Murine Leukemia Viruses—in 86.5 percent of 37 patients and nearly 7 percent of 44 controls.

Read on

 

Paper: Detection of MLV-related virus gene sequences in blood of patients with chronic fatigue syndrome and healthy blood donors

Supporting information:  [PDF  = 4MB]

Download here:

http://www.pnas.org/content/suppl/2010/08/16/1006901107.DCSupplemental

Full paper:

http://www.pnas.org/content/early/2010/08/16/1006901107.full.pdf+html

Or open here, on ME agenda: Full paper

Editorial: Editorial 23.0810

http://www.pnas.org/content/early/2010/08/16/1012027107.full.pdf+html

Commentary: Commentary 23.08.10

http://www.pnas.org/content/early/2010/08/16/1007944107.full.pdf+html  

 

Abstract

http://www.pnas.org/content/early/2010/08/16/1006901107

Detection of MLV-related virus gene sequences in blood of patients with chronic fatigue syndrome and healthy blood donors

1. Shyh-Ching Lo a , 1 ,
2. Natalia Pripuzova a ,
3. Bingjie Li a ,
4. Anthony L. Komaroff b ,
5. Guo-Chiuan Hung a ,
6. Richard Wang c , and
7. Harvey J. Alter c , 1

+ Author Affiliations

1.
aTissue Microbiology Laboratory, Division of Cellular and Gene Therapies and Division of Human Tissues, Office of Cellular, Tissue and Gene Therapy, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, MD 20892;
2.
bDepartment of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA 02115; and
3.
cDepartment of Transfusion Medicine, The Warren Grant Magnuson Clinical Center, National Institutes of Health, Bethesda, MD 20892

1.

Contributed by Harvey J. Alter, May 25, 2010 (sent for review March 23, 2010)

Abstract

Chronic fatigue syndrome (CFS) is a serious systemic illness of unknown cause. A recent study identified DNA from a xenotropic murine leukemia virus-related virus (XMRV) in peripheral blood mononuclear cells (PBMCs) from 68 of 101 patients (67%) by nested PCR, as compared with 8 of 218 (3.7%) healthy controls. However, four subsequent reports failed to detect any murine leukemia virus (MLV)-related virus gene sequences in blood of CFS patients. We examined 41 PBMC-derived DNA samples from 37 patients meeting accepted diagnostic criteria for CFS and found MLV-like virus gag gene sequences in 32 of 37 (86.5%) compared with only 3 of 44 (6.8%) healthy volunteer blood donors. No evidence of mouse DNA contamination was detected in the PCR assay system or the clinical samples. Seven of 8 gag-positive patients tested again positive in a sample obtained nearly 15 y later. In contrast to the reported findings of near-genetic identity of all XMRVs, we identified a genetically diverse group of MLV-related viruses. The gag and env sequences from CFS patients were more closely related to those of polytropic mouse endogenous retroviruses than to those of XMRVs and were even less closely related to those of ecotropic MLVs. Further studies are needed to determine whether the same strong association with MLV-related viruses is found in other groups of patients with CFS, whether these viruses play a causative role in the development of CFS, and whether they represent a threat to the blood supply.

* xenotropic murine leukemia virus-related virus
* murine leukemia virus-like virus
* viral gag gene sequence
* polytropic
* mouse mitochondria DNA PCR

Footnotes

1To whom correspondence may be addressed. E-mail: shyhching.lo@FDA.hhs.gov  or halter@mail.nih.gov .

Author contributions: S.-C.L., N.P., and B.L. designed research; G.-C.H. designed mouse-specific mitochondria PCR assay; N.P. and B.L. performed research; B.L. and R.W. contributed new reagents/analytic tools; S.-C.L., N.P., G.-C.H., and R.W. analyzed data; and S.-C.L., N.P., A.L.K., and H.J.A. wrote the paper.

The authors declare no conflict of interest.

This article contains supporting information online at www.pnas.org/lookup/suppl/doi:10.1073/pnas.1006901107/-/DCSupplemental .

Newswire

http://www.prnewswire.com/news-releases/study-presence-of-murine-leukemia-virus-related-gene-sequences-found-in-cfs-patients-101316939.html 

Study: Presence of Murine Leukemia Virus Related Gene Sequences Found in CFS Patients

Download image SILVER SPRING, Md., Aug. 23 /PRNewswire-USNewswire/ — Researchers have found murine leukemia viruses (MLV) related gene sequences in blood samples collected from patients diagnosed with chronic fatigue syndrome (CFS) and some healthy blood donors, according to a study published online today by the scientific journal Proceedings of the National Academy of Sciences (PNAS).

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO  )

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO  )

Investigators from the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research and the National Institutes of Health Clinical Center, in collaboration with a physician scientist at Harvard Medical School, examined blood samples from 37 patients diagnosed with CFS and from 44 healthy blood donors.

MLV is a type of retrovirus known to cause cancer in mice. Several different MLV gene sequences were identified in samples from 32 of the 37 patients with CFS (87 percent) and 3 of the 44 (7 percent) healthy blood donors. Investigators performed DNA sequencing on all positively amplified samples to confirm MLV like gene sequences.

This study supports a previous investigation [Lombardi et al. Science October 23, 2009 326: 585] that showed XMRV, a genetic variant of MLV-like viruses, to be present in the blood of people with CFS. The study demonstrates a strong association between a diagnosis of CFS and the presence of MLV-like virus gene sequences in the blood. The study also showed that MLV-like viral gene sequences were detected in a small fraction of healthy blood donors. Although the statistical association with CFS is strong, this study does NOT prove that these retroviruses are the cause of CFS. Further studies are necessary to determine if XMRV or other MLV-related viruses can cause CFS.

A previous study, published in 2009, reported finding XMRV infections in a high percentage of CFS patients and a small percentage of healthy blood donors. However, several other studies from the United States (including a recent report from the Centers for Disease Control and Prevention), the United Kingdom, and the Netherlands have found no evidence of XMRV or other MLV-like viruses in the blood of people with CFS.

For more information:

FDA MLV Gene Sequence Study – Questions and Answers http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm223232.html

CDC – XMRV Overview

http://www.cdc.gov/ncidod/dhqp/bp_xmrv.html

CDC – XMRV Questions & Answers

http://www.cdc.gov/ncidod/dhqp/bp_xmrv_qa.html

Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration

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RELATED LINKS
http://www.fda.gov

 

http://www.nih.gov/news/health/aug2010/cc-23.htm

News Advisory
Scientists to discuss research on XMRV in blood, chronic fatigue syndrome

What:

Telebriefing by experts from the Food and Drug Administration, the National Institutes of Health and the Centers for Disease Control and Prevention to respond to questions about this study. The paper is currently under embargo until Monday, August 23 at 3:00 p.m., by the Proceedings of the National Academy of Sciences.

Who:

Harvey Alter, M.D., Chief, Clinical Studies and Associate Director for Research, Department of Transfusion Medicine, NIH Clinical Center

Shyh-Ching Lo, M.D., Ph.D., Director, Tissue Safety Laboratory Program, Division of Cellular and Gene Therapies and Division of Human Tissues, Office of Cellular, Tissue and Gene Therapies, Food and Drug Administration Food and Drug Administration

Celia Witten, M.D., Ph.D., Director, Office of Cellular, Tissue and Gene Therapies, Food and Drug Administration

Hira Nakhasi, Ph.D., Director, Division of Emerging and Transfusion Transmitted Diseases, Office of Blood Research and Review, Food and Drug Administration

Steve Monroe, Ph.D., Director, Division of High-Consequence Pathogens and Pathology, Centers for Disease Control and Prevention

When:

Monday, August 23, 3:01 p.m. EDT
How: Reporters should call 1-888-677-4212 begin_of_the_skype_highlighting 1-888-677-4212 end_of_the_skype_highlighting and enter passcode 9258555. For those unable to participate, the briefing will be available on replay approximately two hours after briefing concludes. For replay, dial 1-866-373-4990 begin_of_the_skype_highlighting 1-866-373-4990 end_of_the_skype_highlighting and enter passcode 5711.

The NIH Clinical Center (CC) is the clinical research hospital for the National Institutes of Health. Through clinical research, physician-investigators translate laboratory discoveries into better treatments, therapies and interventions to improve the nation’s health. For more information, visit http://clinicalcenter.nih.gov .

The National Institutes of Health (NIH) ” The Nation’s Medical Research Agency” includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov .

BRAME Statement about the Lightning Process

BRAME Statement about the Lightning Process

Shortlink: http://wp.me/p5foE-2Zv

According to information received, today, the MEA and Tymes Trust will issue a joint statement later today opposing “unethical” proposed study of Lightning Process effect on children with ME.

BRAME has provided me with the following statement in response to the Bath/Bristol pilot study on Lightning Process for children aged 8 to 18 which does not yet have ethics approval.

Text below or open Word document here: BRAME Lightning Process Statement August 2010

For background to this issue: http://wp.me/p5foE-2Vt

BRAME Statement about the Lightning Process

We (BRAME) have grave concerns about lightening therapy and have voiced these concerns at many meetings, including with the Forward ME group when it was discussed there, and we will continue to do so.

BRAME has always worked/campaigned for ME to be recognised as a neurological illness, as classified by WHO, and have constantly worked to create a greater awareness and understanding of ME, for the complex and debilitating illness we all know it to be, and the impact it has on all those living with ME.

We (BRAME) have also been working hard, for the past 4 years, to try and get a national policy for ME adopted within the NHS, along with the use of the Canadian Clinical Guidelines on ME/CFS, and Canadian Clinical Diagnostic Criteria, to urgently address the paucity of biomedical services for people with ME within the NHS, and to address the national inequality of care. We have consistently raised this with PCTs, SHAs, the All Party Parliamentary Group on ME, various Ministers of Health, and even to Prime Ministers, at Number 10 itself, and within our responses to consultation documents.

Tanya was also patient representative on the CMO Working Group on ME/CFS and the NICE Guideline Development Group on ME/CFS, her response to these can be found on the BRAME website.

When we write to people who want information on BRAME and ME, we always state that:

“If any future health care professional is sceptical about ME, you could politely remind them that:

 Myalgic Encephalomyelitis (ME) and Chronic Fatigue Syndrome (CFS) are classified as neurological illnesses by WHO (ICD10:G93.3).

This WHO classification of ME and CFS is recognised by the Department of Health.

ME/CFS is included in the National Service Framework for Long Term Neurological Conditions.

ME/CFS is recognised as a neurological illness by the Royal College of General Practitioners with a Read Code of F286 (F denotes diseases of the nervous system).

The Canadian Clinical Guidelines on ME/CFS (2003) give consensus diagnostic and management advice which are accepted around the world.

The first 4 main points were reconfirmed by the Health Minister Ann Keen, at the APPG on ME meeting  on 22 January 2008, and by Lord Darzi, in his response to a formal question posed to him by our patron the Countess of Mar, in the House of Lords on 2 June 2008.”

We have also worked with the DWP for many years, raising the problems many people with ME have with the benefit system, and have campaigned for improved benefits, and on behalf of carers, and have been quoted in the government’s recently published white paper on Welfare Reform. We are extremely concerned over the proposals of the new coalition government on changes to benefits and the Work Capability Assessment and migration of people from IB, SDA and IS to the new ESA. We are also concerned over the proposed new medical assessment for those on DLA.

We have written to all the new Ministers but the responses we have received have not been encouraging. We will have to see if the new APPG on ME can be effective in supporting us by raising our grave concerns with the relevant Ministers. Sadly we lost in the election our own, very supportive, MP, Tony Wright, who was responsible for forming the APPG on ME in 1998, and was an officer of the group from 1998 to 2010.

We will continue to raise our concerns about the lightning process, and the need for a national policy on ME calling for biomedical services led by a specialist in ME of consultant level, to be set up nationwide based on the Canadian Guidelines/Diagnosis as set out in the BRAME Guide to Diagnosing, Managing and Caring for people who are Severely/Very Severely Affected by ME.

Tanya Harrison
Chairperson – BRAME
August 2010

http://www.brame.org/

ICD-10-CM codings raised at 10 May CFSAC meeting

ICD-10-CM raised at 10 May CFSAC meeting

Shortlink: http://wp.me/p5foE-2SF

A one day public meeting of the US Chronic Fatigue Syndrome Advisory Committee (CFSAC) was held on Monday, 10 May. Minutes of the previous two day meeting and a Videocast of the proceedings of both days (with subtitles) can be accessed here and here.

The Chronic Fatigue Syndrome Advisory Committee (CFSAC) provides advice and recommendations to the Secretary of Health and Human Services via the Assistant Secretary for Health of the U.S. Department of Health and Human Services on issues related to chronic fatigue syndrome (CFS). More information here [PDF].

Towards the end of the Spring meeting, Dr Leonard Jason, PhD, raised concerns in response to current proposals for the placement of CFS within the forthcoming US “Clinical Modification”, ICD-10-CM, due to be implemented in October 2013. (See foot of this Dx Revision Watch page for current ICD-10-CM proposals.)

Agenda for this Spring 2010 meeting here

CFSAC Agenda – May 10, 2010
Chronic Fatigue Syndrome Advisory Committee
US Department of Health and Human Services

Meeting was webcast live at http://videocast.nih.gov

Webcast of entire meeting with subtitles is now available to view here

Chronic Fatigue Syndrome Advisory Committee
Monday, May 10, 2010
HHS Office on Women’s Health (OWH)
Total Running Time: 05:47:57

More information here: http://videocast.nih.gov/Summary.asp?File=15884

Presentations, Public Testimonies and Written Testimonies here

Transcripts are being compiled on a dedicated Facebook site here

YouTubes videos here:

New Hillary Johnson blog post – “Sif-Sac, again.” here

Cort Johnson blog

A very different looking federal advisory committee on CFS (CFSAC) discussed its charter, its recommendations, XMRV and the blood supply, what the CDC program will look and more. Asst Secretary of Health Dr. Koh, Annette Whittemore and Kim McCleary spoke. Check out the goings on at the CFSAC meeting in

‘The CFSAC on Itself, XMRV, the CDC and More’ from the Bringing the Heat blog:

Phoenix Rising forum thread here

CFSAC Agenda – May 10, 2010

May 10, 2010

9:00 am
Call to Order
Opening Remarks

Roll Call, Housekeeping
Dr. Christopher Snell
Chair, CFSAC

Dr. Wanda Jones
Designated Federal Official

9:15 am
Welcome Statement from the Assistant Secretary for Health

New Members Statement on CFSAC Interests/Goals
Dr. Howard K. Koh

CFSAC New Members

10:00 am
Remarks from Dr. Elizabeth Unger
Dr. Elizabeth Unger

10:30 am
Blood Safety Update on XMRV
Dr. Jerry Holmberg

11:00 am
Review/Update of past CFSAC recommendations
Committee Members

12:30 pm
Subcommittee Lunch
Subcommittee Members

1:30 pm
Public Comment
(on CFSAC charter)
Public

2:00 pm
Review and Discussion of CFSAC Charter and ByLaws
Committee Members

4:00 pm
Adjourn

US Federal Chronic Fatigue Syndrome Advisory Committee: Minutes of October meeting

The Minutes of the October 2009 meeting of the US Federal Chronic Fatigue Syndrome Advisory Committee (CFSAC) are now available

Shortlink: http://wp.me/p5foE-2QP

CHRONIC FATIGUE SYNDROME ADVISORY COMMITTEE (CFSAC)

http://www.hhs.gov/advcomcfs/

Meeting

Thursday, October 29, 2009
9:00 a.m. to 5:00 p.m.

Friday, October 30, 2009
9:00 a.m. to 4:00 p.m.

Room 800, Hubert H. Humphrey Building
200 Independence Avenue, SW
Washington, DC 20201

The document minutes the proceedings of the Chronic Fatigue Syndrome Advisory Committee (CFSAC) Meeting held on October 29-30, 2009.

Download PDF version: http://tinyurl.com/yjarxlf or open here on ME agenda: CFSAC meeting 29.10.09

HTML version: http://www.hhs.gov/advcomcfs/meetings/minutes/cfsac102909min.html

 

Access a podcast video of entire meeting proceedings for Day One and Day Two at:

Day One: http://videocast.nih.gov/Summary.asp?File=15408

Day Two: http://videocast.nih.gov/Summary.asp?File=15409

[Video transmission has Auto Subtitles. RealPlayer required]

Invest in ME: Letter to UK Secretary of State for Health (Blood donation)

Invest in ME: Letter to UK Secretary of State for Health (Blood donation)

Shortlink: http://wp.me/p5foE-2QL

Update @ 19 March 2010

House of Commons Written Answers: 16 March 2010

Hansard transcript

Chronic Fatigue Syndrome: Research

Mr. Drew: To ask the Secretary of State for Health whether his Department has (a) commissioned and (b) evaluated any research on a relationship between myalgic encephalomyelitis and blood-related disorders. [322011]

Gillian Merron: The Department has, to date, not commissioned or evaluated any research. However, others, such as the Medical Research Council, the Health Protection Agency and the UK Blood Services, are currently considering these issues. I refer the hon. Member to the written answer I gave him on 27 January 2010, Official Report, column 942W.

House of Commons Written Answers: 27 January 2010

Hansard transcript

Chronic Fatigue Syndrome

Mr. Drew: To ask the Secretary of State for Health what recent representations he has received on making myalgic encephalomyelitis a notifiable illness for the purposes of blood donation. [313595]

27 Jan 2010 : Column 942W

Ann Keen: The Department has received 31 representations on making myalgic encephalomyelitis a notifiable illness in the last six months. There have also been a number of representations on this subject received by the Chief Medical Officer.

Mr. Drew: To ask the Secretary of State for Health whether his Department plans to (a) commission and (b) evaluate research on the possible health effects of receiving blood donated by a person with myalgic encephalomyelitis. [313596]

Ann Keen: The Department has no current plans to directly commission research on this issue. However, the Medical research Council has designated myalgic encephalomyelitis/chronic fatigue syndrome a priority research area, and will fund proposals of sufficient quality. The UK Blood Services together with the Health Protection Agency are undertaking a study of the prevalence of a rodent virus recently linked to myalgic encephomyelitis, which will be used to inform a risk assessment.

Mr. Drew: To ask the Secretary of State for Health whether his Department plans to test patients for xenotropic murine leukaemia virus-related illnesses. [313607]

Ann Keen: There are currently no plans to test patients for xenotropic murine leukaemia virus-related virus.

House of Commons Written Answers: 10 March 2010

Hansard transcript

10 Mar 2010 : Column 350W

Chronic Fatigue Syndrome: Blood

Mr. Drew: To ask the Secretary of State for Health for what reasons people with myalgic encephalomyelitis may not donate blood. [321320]

Ann Keen: People with myalgic encephalomyelitis (ME), also known as chronic fatigue syndrome (CFS), are not able to donate blood until they have fully recovered. The reasons for this are: first, blood donors need to be in good health, and people with ME/CFS often experience a range of symptoms which could be made worse by donating blood; and second, as the causes of ME/CFS are not currently fully understood, people with the condition are deferred from donating blood as a precautionary measure to protect the safety of the blood supply for patients.

In response , Invest in ME has written to Rt Hon Andy Burnham MP, Secretary of State for Health:

Invest in ME

Letter to UK Secretary of State for Health

Recently Mrs Ann Keen, Under-Secretary of State for Health, commented that people with Myalgic Encephalomyelitis were not able to donate blood. Invest in ME have written the following letter to the Secretary of State for Health, Mr Andy Burnham.

Myalgic Encephalomyelitis and Blood Donations

Rt Hon Andy Burnham MP

Secretary of State for Health

Department of Health

Richmond House

79 Whitehall

London SW1A 2NS

cc: Mrs Ann Keen MP

14th March 2010

Dear Mr. Burnham,

Recently Mrs Ann Keen (in her capacity as Under-Secretary of State for Health) made the following comments in relation to Myalgic Encephalomyelitis and blood donations –

“People with myalgic encephalomyelitis (ME), also known as chronic fatigue syndrome (CFS), are not able to donate blood until they have fully recovered.

The reasons for this are: first, blood donors need to be in good health, and people with ME/CFS often experience a range of symptoms which could be made worse by donating blood; and second, as the causes of ME/CFS are not currently fully understood, people with the condition are deferred from donating blood as a precautionary measure to protect the safety of the blood supply for patients.”

Mrs Keen’s comments are, we assume, representative of the government and your department.

Firstly it is good that your government recognises that people with ME are in poor health. This implies that all people with ME are therefore in need of proper healthcare provision which treats the disease properly.

Secondly it is good that you and your government recognise, by the implication from your statement, that blood supplies may be compromised by accepting people with ME as donors due to the organic nature of this disease.

Thirdly it follows that an embargo on people with ME donating blood would mean that there is an infectious agent at work which could be passed on via blood.

There follows several questions which lead on from this.

It seems to be crucial to use the most stringent diagnostic criteria available for diagnosing ME (which even NICE acknowledge as being the Canadian Consensus Criteria). Yet your department, NICE and the MRC do not standardise on this internationally accepted standard for diagnosis of ME.

When you state that people with ME are not able to donate blood are you employing the NICE guidelines for defining patients as having ME? If so then why does NICE proscribe serological testing unless there is an indicative history of infection? If no initial indication of infection is present then no further blood tests are performed and a patient may receive a diagnosis of ME based on ongoing fatigue and one other symptom such as sleep disturbance. Why then would those patients be excluded from donating blood?

As your government officially accepts ME as a neurological illness, as described by the World Health Organisation ICD-10 G93.3 code, and as the issue of blood contamination from an infectious agent demands the utmost care and attention, is it not of absolute necessity for your government to demand that a consistent set of up-to-date diagnostic criteria are used as standard by all organisations?

Your department often states that the Medical Research Council is an independent body. Yet as it is apparent that the MRC only funds psychiatric studies which presume that ME is a behavioural illness why does your department refuse to comment on the MRC’s usage of the Oxford criteria for research into ME which expressly excludes people with a neurological illness?

Why does your department not criticise the MRC for funding purely psychiatric research into ME if you fully recognise that ME is a disease of organic and infectious nature? Since when did a psychiatric illness prevent blood donations? Does this not clearly show the MRC policy of research into ME for the last generation to be completely flawed and a waste of precious funding and patients’ lives?

When you state that people with ME are not able to donate until fully recovered please can you define what “fully recovered” means?

Could you also provide a description of how a person with ME is defined as no longer having ME?

What biomedical tests are available to determine that a person with ME is “fully recovered”?

Could you inform of how and when clinicians perform such tests in order to ensure that a person is “fully recovered” from ME?

Bearing in mind the seriousness of a possible contamination of blood supplies from people with ME please could you indicate what measures are in place to ensure that doctors do enforce testing to ensure that people with ME are “fully recovered” and will not therefore donate blood?

If such a test exists then presumably people with ME who are not recovered are entitled to appropriate benefits due to incapacity and/or disability?

As relapses are common with people with ME please could you explain if there is any minimum period which a person with ME needs to be “recovered” to be able to donate blood?

Could you also provide information which your government has on the number of people with ME in this country, the proportion of patients who have had ME for longer than five years and how many people with ME have “fully recovered”?

With regard to your statement that “the causes of ME/CFS are not currently fully understood” is it not inherent on the Chief Medical officer of the UK to attend the 5th Invest in ME International ME/CFS Conference 2010 on 24th May in Westminster, as guest of Invest in ME?

As the foremost experts on ME in the world are presenting at the conference, along with the Whittemore-Peterson Institute – who have recently been involved in the discovery of the XMRV retro-virus which has possibly huge considerations for the blood supply of this country – would it not be sensible for anyone who is involved in healthcare and particularly in the treatment of people with ME to attend this event?

Should not the government of this country also be sending a representative to the conference given that contamination of the blood supply by people with ME may be occurring and that education about the disease needs to be a pre-requisite for anyone involved in healthcare provision for people with ME?

We would request that you provide a full and complete answer to every single one of the questions which we have asked in this letter and we look forward to your reply,

Yours Sincerely,

The Chairman and Trustees of Invest in ME

Invest in ME

Registered UK Charity Nr. 1114035

PO BOX 561, Eastleigh SO50 0GQ

Support ME Awareness – Invest in ME

Related material:

Donations and transfusions: Safety of the UK blood supply  13 February 2010