Agenda: MRC CFS/ME Research Workshop 19-20 November 2009

Agenda: MRC CFS/ME Research Workshop 19-20 November 2009

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I have received the following response, today, from Ms Rosa Parker, Corporate Governance and Policy, Medical Research Council under the FOI Act:

 Workshop AGENDA in PDF format:  Agenda MRC CFS/ME Workshop 19 – 20 November

I had asked for:

1] A copy of the Agenda for this event.

2] A list of partipants for this event

3] Clarification of whether the CFS/ME Expert Group intends to continue to hold meetings beyond the Conference / Workshop in November.

Ms Parker’s response:

“The agenda has now been finalised and circulated, a copy is attached. We are still in discussion with colleagues regarding the participants list and will respond to this part of your request in due course. You also asked whether the Expert Group intends to hold any further meetings following the Workshop; I can confirm that the Expert Group does intend to hold a meeting following the workshop. The dates of this meeting have yet to be confirmed, the note of this third meeting will be published on our website in due course.

“You have now also asked a couple of additional questions. You have asked whether a note or report of the workshop will be available. I can confirm that a note of the workshop will be published on our website, but I am not able to confirm the timescale at this stage. You have also asked about the minutes of the second meeting of the Expert Group. The minutes are currently being finalised and as soon as they have been approved they will be made available on our website, at the moment we expect this to be within the next month.”

“I hope that this information is helpful, and I will be in touch regarding the participants list in due course.”

Rosa Parker
Corporate Governance and Policy, Medical Research Council

11 November 2009

Link back

MRC Two day Research Workshop 19 and 20 November 2009

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The Agenda and Minutes of the meeting on 15 December can be downloaded here or opened in PDF format here:

PDF: Minutes CFS/ME Expert Group Meeting 15 December 2008

Document Library
CFS/ME Expert Group meeting – 15 December 2008
Issued: 15 Dec 2008
Primary audience: Researchers
Document Summary

The list of members can be opened in PDF format here:

PDF: CFS/ME Expert group membership

Term of Reference can be opened in PDF format here:

PDF: Finalised Terms of Reference for CFS/ME expert group

or go to MRC site for full article and files:

Chronic Fatigue Syndrome/Myalgic Encephalomyelitis 

( http://www.mrc.ac.uk/Ourresearch/ResearchFocus/CFSME/index.htm )

ME Association: Updates: Blood Donation, XMRV and ME/CFS Version 3

Two further statements around the XMRV study have been issued by the ME Association (UK) and are published, in full, below this preamble:

“There is an immediate need for international agreement and co-operation on the research criteria being used to select well-characterised ME/CFS patients for further research into XMRV. Otherwise, we could end up in 2010 with a collection of conflicting results on prevalence because different international research groups have been using different patient selection criteria.

In the present situation, with many research groups reluctant or unwilling to use Canadian criteria, and not having stored samples from patients that meet Canadian criteria, the best way forward may be for everyone to agree to use Fukuda defined CFS. We may then be able to draw some conclusions about which people who come under the wide clinical spectrum of CFS clinical presentation have XMRV and which do not.”

Why is the MEA not recommending use of the more rigorous Canadian Criteria for replication studies?

Several years ago, the MEA held a formal postal ballot amongst its membership to vote for or against a proposal that the MEA should adopt the Canadian Criteria. Cases for and against adoption were published in the MEA’s magazine, ME Essential, with Dr Shepherd presenting the case against adoption. Of the very small percentage of the membership that returned a vote, the majority vote was in favour of adoption. The MEA announced the adoption “in principle” of the Canadian Criteria, then deftly kicked the Canadian Criteria under the carpet.

 “…Demonstrating a link between a retrovirus and ME/CFS does not, by itself, resolve the physical vs psychological debate. Research studies have demonstrated links between retroviruses and diseases as diverse as autoimmune disorders (which could be relevant to ME/CFS), immunodeficiency diseases, multiple sclerosis, tumours, anaemias and even schizophrenia.”

I am not a member of the MEA; I was barred from membership of the Association in 2005 by Chair’s Action. A subsequent application to become a member of the Association was voted against by the Board of Trustees. The Association has the power, within the framework of its constitution, its Memorandum and Articles of Association, to deny membership to anyone it decides not to admit to membership [Clause 4.1 (b)]. Were I a member, however, I would be demanding an explanation from Dr Shepherd of what he means by the first sentence of the statement above.

 

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1] XMRV and blood donation – update following letter to the Chief Medical Officer (02.11.09)

2] XMRV and ME/CFS:  WHAT DO WE KNOW SO FAR?  AND WHAT DON’T WE KNOW? (VERSION 3) (04.11.09)

 

1] XMRV and blood donation – update following letter to the Chief Medical Officer (04.11.09)

http://www.meassociation.org.uk/content/view/1067/161/

XMRV and blood donation – update following letter to the Chief Medical Officer

The ME Association wrote to Sir Liam Donaldson, Chief Medical Officer at the Department of Health, on Tuesday 27 October about XMRV research. In particular, we raised the situation regarding people with ME/CFS and blood donation.

Click  http://www.meassociation.org.uk/content/view/1059 

to read a copy of this letter.  An acknowledgement from the CMO has been received.

We are today writing to the CMO again to pass on the interim guidelines about blood donation and ME/CFS in America that have been issued by Dr John Niederhuber from the National Cancer Institute, US National Institutes of Health. This information was requested from the NCI by the CFIDS Association of America and has been published on their website:

http://www.cfids.org/temp/xmrv-guidelines-nci.asp

The MEA is very keen to build up an international database on the situation regarding blood donation and any information from people or support groups in other countries would be welcomed.

Following contact and discussions last week with a number of virologists and retrovirologists involved with XMRV research, the MEA will be updating our position statement on XMRV later in the week.

We shall also be repeating our offer to help fund good quality XMRV research here in the UK through the MEA Ramsay Research Fund:

http://www.meassociation.org.uk/content/view/30/205/

——————–

2] XMRV and ME/CFS:  WHAT DO WE KNOW SO FAR?  AND WHAT DON’T WE KNOW? (VERSION 3) (04.11.09)

http://www.meassociation.org.uk

Version 3 clarifies some of the points and queries raised in the previous two MEA statements and summarises the  various actions now being taken by the  ME Association.

It also updates the situation on XMRV research initiatives in the UK, testing for XMRV and refers to our letter to Sir Liam Donaldson, the Chief Medical Officer, regarding blood supplies and blood donation.

This summary is intended to be a balanced account which not only raises questions but is also very cautious when it comes to drawing any firm conclusions about the role of XMRV in ME/CFS at this very early stage in the research.

BACKGROUND

On Friday 9 October, the front page of the UK Independent newspaper carried a major news item under the heading ‘Has science found the cause of ME?’

This referred to new research findings from America which indicate that a recently discovered retrovirus, known as XMRV (xenotropic murine leukaemia virus-related virus), could be playing an important role in causing or maintaining ME/CFS. The news item was accompanied by a very supportive editorial about the need for recognition and research into ME/CFS. These two items can be read here:

http://www.meassociation.org.uk/content/view/1068/161/

The Independent story was soon followed up by the rest of the UK media, including the BBC. Most of the news reports gave a reasonably balanced and accurate account of the research. However, some reports incorrectly inferred that the cause of ME/CFS had now been conclusively discovered and that an effective antiviral treatment would soon be available. A selection of UK media reports can be found in the October news archive on the MEA website.

The actual research paper was published in the online edition of Science, along with a perspective written by John Coffin (Department of Molecular Microbiology, Tufts University, Boston, USA) and Jonathan Stoye (National Institute for Medical Research, London).

References:

Detection of an infectious retrovirus, XMRV, in blood cells of patients with chronic fatigue syndrome. Lombardi V et al. Science October 8 2009

http://www.sciencemag.org/cgi/content/abstract/1179052

Abstract

A new virus for old diseases? Coffin JM and Stoye JP.  Science October 8 2009 326; p215

http://www.sciencemag.org/cgi/content/abstract/1181349

These papers are also available on the WPI website http://www.wpinstitute.org

Additional online data from the study can be obtained if required.

XMRV AND PROSTATE CANCER

XMRV has also been found in an American study in men who have prostate cancer. This was partly why the ME/CFS study was carried out. However, the most recent study on XMRV in prostate cancer from Germany has queried any such a link and suggested that one possible reason could be a geographically restricted incidence of XMRV infections. An additional explanation involves the type of laboratory testing for XMRV used in the two studies. The precise role of XMRV in prostate cancer remains uncertain.

Reference:

Lack of evidence for xenotropic murine leukaemia virus-related virus (XMRV) in German prostate cancer patients. Retrovirology 2009, 6:92. Available on-line here:

http://www.retrovirology.com/content/6/1/92

MEA POSITION ON XMRV

These are potentially important research findings that could help with both the diagnosis and management of ME/CFS. We congratulate all those involved in deciding to do this research study.

However, a number of difficult questions have to be answered before anyone can conclude that this virus plays a significant role in either the cause, transmission, clinical assessment or management of ME/CFS.

The research has demonstrated a correlation between ME/CFS and XMRV – not that it is the causative infection.

Much more epidemiology and laboratory work now needs to be done to answer the essential points set out below:

o Carrying out further and larger studies using different populations of people in different countries with ME/CFS. This work should include people at different stages of the illness (to see if the virus is present in the same percentages in both early and late cases) and in all degrees of severity. Research in different countries is vital in view of the conflicting geographical findings relating to XMRV in prostate cancer.

o Using different international laboratories to test for evidence of the virus.

o Establishing a battery of properly validated tests for XMRV that can be consistently used in further research studies.

o Assessing what, if any, correlation there is between the presence of this virus and (a) severity of symptoms, (b) a clear infectious onset with a known infection, (c) immune system abnormalities, CD4 abnormalities in particular, and (d) various other factors involved in sub-grouping of people under the ME/CFS umbrella.

o Assessing to what extent this particular retrovirus virus is also present in other chronic conditions, especially those such as autism, multiple sclerosis and lymphoma where viral infections have been implicated as a causative factor.

o Assessing whether this virus is acting as a benign marker of disease or immune dysfunction, is a ‘passenger virus’, or whether it has a role in the actual disease process and development of symptoms.

o Investigating whether the presence of the virus in healthy people acts as a predisposing factor in the development of ME/CFS (possibly when another infective trigger appears) and/or prostate cancer – rather than being involved in the actual disease process.

o Investigating what effect, if any, the virus has in healthy people who carry it over a period of time.

o Assessing whether people with evidence of XMRV should be treated with antiretroviral medication, and if so developing a suitable antiviral drug or combination of antiviral drugs.

o Assessing whether animal model studies would help to increase our understanding of the way in which this virus may infect cells and possibly cause human disease.

TESTING FOR XMRV IN THE UK AND USA

Until these research findings have been properly replicated, and we have the answers to some of the above questions, there is no point in asking your doctor to be tested for XMRV. This is because the NHS does not currently have the facilities to do so and the testing procedures are only being used in a research capacity at present. But, if it does turn out that there is a consistent and strong association with ME/CFS, then testing for XMRV would almost certainly have to be made available on the NHS.

We are not aware of any private pathology laboratories here in the UK that are able to test for XMRV, or are intending to start offering to carry out testing.

Dr Vincent Lombardi, primary investigator and lead author of the Science paper is Director of Operations for XMRV testing at Viral Immune Pathology Diagnostics VIPDx – a commercial laboratory in America. This testing facility is not available to people living outside the US.

VIRAL TRANSMISSION

We know that some people with ME/CFS are now very concerned about the possibility of transmission of XMRV through what are termed body fluids (ie blood, saliva, semen). However, until we know more about what this virus does in the body it would be premature to start arriving at firm conclusions and recommending all kinds of restrictions to normal daily living.

Remember: we still do not know for certain whether this is a disease-causing virus in humans and whether it plays a role in causing or maintaining ME/CFS.

And if this virus was behaving as an ‘ME virus’ in the way that HIV, another retrovirus, causes and transmits HIV infection, often leading to AIDS, there would be a significant number of sexual partners of people with ME/CFS developing ME/CFS. But this is clearly not the case.

One simple way of obtaining some early clues about viral transmission of XMRV would be to test for the presence of the virus in healthy partners and offspring of people who have the infection and comparing the findings to a control group of people that have no such link.

PRESENCE OF XMRV IN THE HEALTHY POPULATION

If this virus is also present in up to 4% of the normal healthy population here in the UK (ie around 2.4 million, or ten times the number of people who have ME/CFS), as appears to be the case in America, and it does play a significant role in diseases such as ME/CFS and prostate cancer, there will be widespread and very serious implications for public health, blood donation etc. This could also include vaccination against the virus and treating people who are XMRV positive. These are complex decisions which can only be made in the light of further research studies.

BLOOD DONATION AND XMRV

In relation to blood donation in the UK, current advice is that people with ME/CFS who have symptoms, or are receiving treatment, should not donate blood. It would seem sensible in the short term, until we know more about transmission and pathogenicity of XMRV, to consider extending this restriction to people who have recovered from ME/CFS. It seems strange that many overseas countries have not followed the UK lead on blood donation and ME/CFS.

The MEA has now written to Sir Liam Donaldson, Chief Medical Officer at the Department of Health, regarding the possibility of XMRV being transmitted via human blood products and the implications that this has for blood donation. A copy of this letter can be read here:

http://www.meassociation.org.uk/content/view/1059/

The CFIDS

Association of America has been issued with guidance from the National Cancer Institute regarding blood donation in the US. The guidance can be read on the CFIDS website:

http://www.cfids.org/temp/xmrv-guidelines-nci.asp

WHAT CAN WE LEARN ABOUT THE ROLE OF INFECTION FROM OUTBREAKS OF ME/CFS?

It should be noted that unlike the retroviral infection HIV, ME/CFS is an illness that occurs both sporadically and in highly localised acute geographical outbreaks, often involving closed communities such as schools and hospitals, where there is no obvious evidence of bodily fluid transmission. This fact would obviously question the role of XMRV as a precipitating infection in the onset of the illness.

In the pivotal Royal Free Hospital outbreak of ME back in 1955, far more than 4% of a previously healthy population of doctors and nurses contracted an unknown infection at roughly the same time (the hospital had to close due to lack of staff). This fact would question the role of XMRV as a key predisposing factor if it only occurs in 4% of the population.

TREATMENT OF XMRV: ANTIRETROVIRAL DRUGS AND VACCINE

Until we know more about the possible role of XMRV in ME/CFS there is no point in asking your doctor about antiviral drug treatment. If it turns out that the virus does play a role in causing or maintaining ME/CFS then antiviral drug treatment will need to be investigated. This will involve clinical trials to test possible drug treatments for both safety and efficacy – a process that normally takes a considerable amount of time and money.

The 2007 NICE Guideline on ME/CFS specifically states that doctors should not use antiviral medication to treat ME/CFS. This dogmatic position is unlikely to change without clear evidence of benefit in good quality randomised clinical trials. We understand that the NICE guideline will be reviewed in late 2010.

Vaccination against XMRV has also been raised as a possibility.

ROLE OF THE MEA RAMSAY RESEARCH FUND, VOLUNTEERING FOR RESEARCH and THE MEDICAL RESEARCH COUNCIL

The ME Association is keen to progress this research here in the UK through any way we can help. We have already made contact with virologists and retrovirologists who are interested in this virus here in the UK, and we are aware of at least four sound research groups who are keen to pursue this work. Funding from the Ramsay Research Fund (RRF) could be made available very quickly if we receive a good quality research proposal. However, our contacts and discussions with UK researchers so far indicate that short term funding is not an immediate problem and that initial plans can probably be covered from existing budgets.

More information on the work of the RRF can be found here:

http://www.meassociation.org.uk/content/view/30/205/

Since publication of these results it has become apparent that a number of international research groups outside the US and UK are also intending to try and confirm or refute the findings. The MEA has been contacted in relation to two such groups from overseas. This is obviously good news and should help to clear up some of the immediate uncertainties.

If volunteers are required for any research taking place in the UK we will place an announcement on the MEA website.

The Medical Research Council’s Expert Group on ME/CFS research (membership includes Dr Jonathan Kerr and Dr Charles Shepherd) will be holding a two day research workshop on 19 – 20 November where XMRV will obviously be one of the topics under discussion.

SELECTING PEOPLE FOR FURTHER RESEARCH STUDIES

There is an immediate need for international agreement and co-operation on the research criteria being used to select well-characterised ME/CFS patients for further research into XMRV. Otherwise, we could end up in 2010 with a collection of conflicting results on prevalence because different international research groups have been using different patient selection criteria.

In the present situation, with many research groups reluctant or unwilling to use Canadian criteria, and not having stored samples from patients that meet Canadian criteria, the best way forward may be for everyone to agree to use Fukuda defined CFS. We may then be able to draw some conclusions about which people who come under the wide clinical spectrum of CFS clinical presentation have XMRV and which do not.

Besides using stored blood samples, research needs to involve fresh clinical cases, as well as other disease groups (particularly inflammatory conditions with immune activation) and properly matched healthy controls.

KEY FACTS ABOUT THE XMRV RESEARCH

http://www.wpinstitute.org

o An American group from the Whittemore Peterson Institute, in collaboration with the National Cancer Institute and the Cleveland Clinic, have reported finding evidence of a human retrovirus known as XMRV in blood samples taken from people with ME/CFS.

o Using peripheral blood mononuclear cells, DNA (viral genetic material) from the virus was found in 67% of patients (68/101) compared to 3.7% in healthy controls (8/218).

o The XMRV virus was shown to grow in cell culture in the laboratory.

o Further studies have found that 95% of people with ME/CFS have antibodies to the virus – indicating an immune response to a recent or past infection.

o Blood samples were collected from people with what is referred to in the paper as CFS who live in different parts of the United States, as well as from healthy controls. More information on the patient and control cohorts can be found on the WPI website.

o A more detailed, but easy to understand, summary of the XMRV research has been prepared by Dr Suzanne Vernon for the CFIDS Association of America. This can be read at the CFIDS website. A press release summary produced by the National Cancer Institute is also worth reading:

http://www.cfids.org/cfidslink/2009/110402.asp

o The paper in Science does not provide any detailed information about the patient group (ie age, gender, illness characteristics) or control group. However, a report on the research published in The Wall Street Journal states that 20/101 people in the CFS group also had a lymphoma, a type of cancer affecting the lymph nodes. Questions have therefore been raised about the inclusion of these patients in the CFS group, as well as the makeup of the control group and how these patients were selected. See commentary from Professor Andrew Lloyd published on the website of the ME/CFS Society of NSW, Australia:

http://www.me-cfs.org.au/node/448

The WPI have now stated in a website response that none of the results in the Science paper relate to people with CFS plus lymphoma.

KEY FACTS ABOUT RETROVIRUSES

o Retroviruses infect a wide range of animal species.

o Human retroviruses consist of HIV (causing AIDS) , HTLV-1 (causing T-cell leukaemias and lymphomas) and HTLV-2 (often asymptomatic and not yet clearly linked to any specific disease).

o They were discovered in the 1980s when it became possible to culture T-cells in vitro.

o They infect CD4-bearing lymphocytes – a special type of immune system cell that is derived from the thymus gland.

o Endogenous retroviruses (ERVs) are also found in humans and usually cause no ill effects. Defective retroviruses which integrate into the host genome are passed down from generation to generation. And 2% of the human genome is made up of endogenous retroviral sequences.

o Retroviruses are enveloped viruses, with an RNA genome. The name retrovirus is derived from the fact that the virus particle contains an RNA-dependent DNA polymerase – reverse transcriptase. This enzyme converts the RNA genome into DNA, which then integrates into the host chromosomal DNA. The reverse transcriptase enzyme is highly error prone and rapid genetic variation is a feature of this group of viruses.

KEY FACTS ABOUT XMRV: Xenotropic murine leukaemia virus-related virus

o XMRV is a gammaretrovirus that was first described in 2006 in a group of men who had prostate cancer.

o It may also be linked to other medical conditions, including fibromyalgia.

o XMRV is closely related to a group of retroviruses that can infect mice.

o This type of virus is thought to be transmitted through body fluids such as blood, semen and breast milk. It is not thought to be transmitted through the air – like a flu virus. But the route of transmission remains uncertain.

o Testing for evidence of the XMRV virus in blood is currently only available at a few specialised laboratories here in the UK. Demonstrating a link between a retrovirus and ME/CFS does not, by itself, resolve the physical vs psychological debate. Research studies have demonstrated links between retroviruses and diseases as diverse as autoimmune disorders (which could be relevant to ME/CFS), immunodeficiency diseases, multiple sclerosis, tumours, anaemias and even schizophrenia.

CONCLUSIONS

The bottom line to this interesting research is that it currently raises more questions than answers.

o Does the presence of XMRV in healthy people make them more likely to develop ME/CFS when another infection appears?

o Does XMRV cause ME/CFS in some cases? Or does XMRV become active as a result of having ME/CFS?

o Or is it simply an innocent bystander with no role in the illness?

o Should XMRV be treated?

When we have accurate answers to at least some of these questions we can move forward, if necessary, with testing and treatment.

We will update this summary as further information becomes available.

If you want to comment on it please do so via the MEA Website.

Dr Charles Shepherd
Hon Medical Adviser, ME Association

Summary 3 dated 4 November 2009

ME in Parliament: Written Answers: 26 June, 1 July, 7 July 09

ME in Parliament: Written Answers: 26 June, 1 July, 7 July 09

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As circulated by Dr Marc-Alexander Fluks

Source: UK House of Commons
Date: June 26, 2009
URL: http://www.publications.parliament.uk/pa/cm200809/cmhansrd/cm090626/text/90626w0012.htm
Ref: http://www.me-net.combidom.com/meweb/web1.4.htm#westminster

[Written Answers]

Business, Innovation and Skills – Chronic Fatigue Syndrome

Lynne Jones

To ask the Minister of State, Department for Business, Innovation and Skills with reference to the answer to the right hon. Member for Horsham of 21 April 2008, Official Report, column 1785W, on chronic fatigue syndrome: research, when the Medical Research Council plans to set up a panel of experts from different disciplines to look at the subtypes and causes of myalgic encephalomyelitis/chronic fatigue syndrome. [281820]

Mr. Lammy

The Medical Research Council (MRC) set up in 2008 a panel of experts from different disciplines to look more closely at chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). The group is reviewing the current research and will identify additional opportunities with the aim of stimulating further research into CFS/ME, in particular focusing on the causes of the condition. The MRC hopes that this will encourage new research towards understanding the aetiology and subtypes of CFS/ME and lead to an advancement of knowledge in this field and the development of new therapeutic approaches.

(c) 2009 Parliamentary copyright

——————

Source: UK House of Commons
Date: July 1, 2009
URL: http://www.publications.parliament.uk/pa/cm200809/cmhansrd/cm090701/text/90701w0021.htm
Ref: http://www.me-net.combidom.com/meweb/web1.4.htm#westminster

[Written Answers]

Chronic Fatigue Syndrome

Mr. Greg Knight

To ask the Secretary of State for Health (1) what recent assessment he has made of his Department’s guidelines for the treatment of myalgic encephalopathy compared to international best practice; [283105] (2) what recent representations he has received on the revision of treatment guidelines for myalgic encephalopathy issued to trusts by his Department. [283106]

Ann Keen

The Department has not issued guidelines for the treatment of myalgic encephalopathy. Guidelines for the diagnosis and management of chronic fatigue syndrome/myalgic encephalomyelitis were published in 2007 by the National Institute for Health and Clinical Excellence. They would have responsibility for revising this guidance.

(c) 2009 Parliamentary copyright

——————

Source: UK House of Commons
Date: July 7, 2009
URL: http://www.publications.parliament.uk/pa/cm200809/cmhansrd/cm090707/text/90707w0031.htm
Ref: http://www.me-net.combidom.com/meweb/web1.4.htm#westminster

[Written Answers]

Chronic Fatigue Syndrome

Lynne Jones

To ask the Minister of State, Department for Business, Innovation and Skills pursuant to the answer of 26 June 2009, Official Report, columns 1198-99W, on chronic fatigue syndrome, who the members of the panel of experts are; and how often it has (a) met and (b) reported on its findings. [283743]

Mr. Lammy

The membership of the expert group set up by the Medical Research Council is as follows:

Professor Jill Belch (Chair) – University of Dundee,
Professor Stephen Holgate – University of Southampton,
Dr. Esther Crawley – University of Bristol,
Professor Philip Cowen – University of Oxford,
Professor Malcolm Jackson – University of Liverpool,
Dr. Jonathan Kerr – St George’s University of London,
Professor Ian Kimber – University of Manchester,
Professor Hugh Perry – University of Southampton,
Dr. Derek Pheby – National CFS/ME Observatory,
Professor Anthony Pinching – Pennisula Medical School,
Dr. Charles Shepherd – ME Association,
Sir Peter Spencer – Action for ME,
Professor Peter White – Bart’s and the London School of Medicine and Dentistry.

The Expert Group has met twice, in December 2008 and March 2009. The notes of those meetings will be published  on the MRC website shortly, and will then be accessible to the public.

(c) 2009 Parliamentary copyright

————-

Notes:

1] For Minutes of the December 08 meeting of the MRC “CFS/ME Expert Group” see previous posting: MRC Two day Research Workshop 19 and 20 November 2009: http://wp.me/p5foE-2bS. 

Minutes for the March 09  meeting have not yet been published.

2] The MRC “CFS/ME Expert Group” is chaired by Professor Stephen Holgate.

3] No Agenda or list of partipants has been issued for the two day MRC “CFS/ME Expert Group” scheduled for 19 – 20 November. I have submitted a request to the MRC for information under the FOIA for a copy of the Agenda, the list of participants and for clarification of whether the MRC “CFS/ME Expert Group” anticipates holding further meetings beyond the November workshop.

4] The NICE Guideline for CFS/ME (CG 53) is currently scheduled for review in August 2010.

NIH $1.6 Million award for ME/CFS Research for Drs. Mikovits & Kerr

XMRV Retrovirus Whittemore Peterson CFS study Media Round up: 13

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Media

Source: Prohealth

http://www.prohealth.com/library/showarticle.cfm?libid=14948

NIH Bets $1.6 Million on Continued ME/CFS Research by Drs. Mikovits & Kerr*

October 21, 2009

Dr. Judy Mikovits (principle investigator) and the Whittemore-Peterson Institute, with collaborator Dr. Jonathan Kerr, have been awarded a 5-year, $1.6 million grant from the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) to support ongoing research into the disease mechanisms of chronic fatigue syndrome. Dr. Kerr is associated with St. George’s College in London.

The award was announced Sep 24 on the WPI website, before news of the CFS-associated XMRV retrovirus was published Oct 8 by the journal Science. A description of the project (# 1R01AI078234-01A2) is now included in the NIH’s Research Portfolio Online.

( http://projectreporter.nih.gov/reporter.cfm?CFID=7257406&CFTOKEN=97499939 )

Key Details from the NIH’s Project Description

• Title: “New Strategies to Decipher the Pathophysiology of Chronic Fatigue Syndrome.”

• Objective: “To provide significant insight into the disease mechanisms of Chronic Fatigue Syndrome so accurate testing and specific treatments can be developed with a goal of curing the disease and preventing life-threatening complications.”

• Timing: start date Sep 28, 2009; projected end date, Aug 31, 2014.

• Funding: First fiscal year funding $335,600; total funding $1.6 million.

• Project Description provided by applicant: (excerpt formatted for greater legibility, as follows).

______________________________

“Chronic Fatigue Syndrome (CFS) is a complex disease estimated to affect between 0.5%-2% of the population in the Western world.

Its pathogenesis is thought to involve both inherited and environmental (including viral) components, as with other chronic inflammatory diseases, such as multiple sclerosis, rheumatoid arthritis, and atherosclerosis.

Consistent with this chronic inflammatory context, CFS patients are known to have a shortened life-span and are at risk for developing lymphoma. We hypothesize that chronic inflammatory stimulation from active and recurrent infections of multiple viruses on a susceptible host genetic background leads to the pathogenesis characterized by CFS.

The overall goal of this research project is to define these viral and host parameters in European and American cohorts of CFS patients that correlate with distinct disease phenotypes, including the development of mantle cell lymphoma (MCL) in a subgroup of the American cohort.

In Aim 1) we will identify and confirm novel viral infections in European and American CFS patient cohorts.

1.1) We will use two complementary methods for detection of novel virus mRNA: massive parallel signature sequencing (MPSS) and a custom DNA microarray.

1.2) Quantitative polymerase chain reaction Q-PCR will be used for confirmation of virus gene expression.

1.3) Immortalized cell lines will be developed to isolate virus and elucidate links between virus and host cell gene expression.

In Aim 2), we will elucidate genetic factors of susceptibility and the dysregulation of the host defense system. Specifically, we will determine:

2.1) PBMC gene expression of 88 human genes previously confirmed as being differentially expressed in CFS

2.2) Serum chemokine and cytokine profiles using multiplex suspension antibody arrays on a Luminex platform

2.3) HLA, KIR genotypes and whole genome SNP profiles

2.4) Defects in the type I Interferon signaling pathway.

In each subaim both cohorts will be compared to normal and disease controls using specimens of serum and PBMC taken at multiple time-points from individual patients and taken from our unique and extensive sample repository.

This study:

• Will provide information necessary for development of treatment and diagnostic strategies for distinct subgroups of CFS patients,

• And may identify novel virus associations, genetic signatures, and biomarkers, which can predict the development of MCL, thus enabling use of preventive therapeutics.”….

 

[*Ed: Dr. Jonathan Kerr is a member of the Research Committee for the UK CFS Research Foundation; Dr Kerr is also a member of the MRC's CFS/ME Expert Group  which is chaired by Professor Stephen Holgate.  Professor Holgate is also a member of the CFS Research Foundation's Research Committee. ]

—————–

Patient community websites, blogs, commentaries

Previous material in the XMRV series of Media updates has referred to “Koch’s postulates”

Jean Harrison, via Co-Cure, 22 October 2008:

From Wikipedia (admittedly not always the best source, but in this case pretty sound)

“1.The microorganism must be found in abundance in all organisms suffering from the disease, but should not be found in healthy animals.

2.The microorganism must be isolated from a diseased organism and grown in pure culture.

3.The cultured microorganism should cause disease when introduced into a healthy organism.

4.The microorganism must be reisolated from the inoculated, diseased experimental host and identified as being identical to the original specific causative agent.

Koch’s postulates were developed in the 19th century as general guidelines to identify pathogens that could be isolated with the techniques of the day.[3] Even in Koch’s time, it was recognized that some infectious agents were clearly responsible for disease even though they did not fulfill all of the postulates.[2][4] Attempts to rigidly apply Koch’s postulates to the diagnosis of viral diseases in the late 19th century, at a time when viruses could not be seen or isolated in culture, may have impeded the early development of the field of virology.[5][6] Currently, a number of infectious agents are accepted as the cause of disease despite their not fulfilling all of Koch’s postulates.[7] Therefore, while Koch’s postulates retain historical importance and continue to inform the approach to microbiologic diagnosis, fulfillment of all four postulates is not required to demonstrate causality.”

Source: http://en.wikipedia.org/wiki/Koch’s_postulates

—————–

Previous ME agenda Media Round ups

Round up 13: NIH $1.6 Million award for ME/CFS Research for Drs. Mikovits & Kerr: http://wp.me/p5foE-2co (you are here)

Round up 12: XMRV Retrovirus Whittemore Peterson CFS study Media Round up 12: http://wp.me/p5foE-2c2

Round up 11: XMRV Retrovirus Whittemore Peterson CFS study Media Round up 11: http://wp.me/p5foE-2bB

Round up 10: Whittemore Peterson Institute XMRV retrovirus study link with CFS (Science journal):
http://wp.me/p5foE-2bk

Round up 9: Notice from Dr David Bell, Lyndonville News; Article by Paul R. Cheney MD, PhD:
http://wp.me/p5foE-2aQ

Round up 8: XMRV retrovirus study: Position statement from ME Association 14.10.09: http://wp.me/p5foE-2at

Round up 7: XMRV Retrovirus: Whittemore Peterson Institute: CFS: Media Round up 7: http://wp.me/p5foE-2aa

Round up 6: XMRV Retrovirus: Whittemore Peterson Institute Chronic Fatigue Syndrome study: Videos and audios: http://wp.me/p5foE-29L

Round up 5: Supporting Online Material for XMRV Chronic Fatigue Syndrome study: http://wp.me/p5foE-299

Round up 4: XMRV Retrovirus: Whittemore Peterson Institute Chronic Fatigue Syndrome study:
http://wp.me/p5foE-28F

Round up 3: Whittemore Peterson Institute (WPI) Chronic Fatigue Syndrome retrovirus XMRV in the media: http://wp.me/p5foE-280

Round up 2: Science 9 October 2009: Whittemore Peterson Institute (WPI) Chronic Fatigue Syndrome link to retrovirus: 08.10.09: http://wp.me/p5foE-27v

Round up 1: Whittemore Peterson Institute (WPI) Chronic Fatigue Syndrome link to retrovirus: 09.10.09: http://wp.me/p5foE-272

MRC Two day Research Workshop 19 and 20 November 2009

MRC Two day Research Workshop 19 and 20 November 2009

WordPress Shortlink: http://wp.me/p5foE-2bS

May be reposted

Research into CFS and ME has been designated a UK Medical Research Council “high priority” area. The MRC convened a Research Advisory Group in 2003 and did a lot of talking. Six years down the line, with a Bill Reeves (CDC) chaired joint MRC/Action for M.E. Research Summit, a new multidisciplinary panel and a lot more talk, we are still waiting for the MRC to put its money where its mouth is. The new MRC Expert Group on CFS/ME Research meets in November for a two day research workshop. For how many more years is the MRC going to be talking about its objective to encourage and conduct high-quality research into CFS and ME?  

The MRC CFS/ME Expert Group, chaired by Professor Stephen Holgate, has scheduled a two day research workshop for 19 and 20 November.

Since no details of this Research Workshop have been published by the MRC or by Action for M.E. or the ME Association (who attend meetings of the group), I have, today, submitted a request to the MRC for information under the Freedom of Information Act.

I have requested:

A copy of the Agenda for the two day research workshop scheduled for 19 and 20 November.

A copy of the list of participants for the research workshop.

Clarification of whether the MRC CFS/ME Expert Group intends to continue to hold meetings beyond the two day research workshop.

The MRC are obliged to provide a response within 20 working days.  I anticipate a response on or before Friday, 13 November and will update you then.

 

For Minutes of the December meeting of the MRC CFS/ME Expert Group see previous posting:

http://wp.me/p5foE-1UW

The list of members and the Panel’s Terms of Reference were previously obtained by me under FOIA and published here on ME agenda.

The Agenda and Minutes of the meeting on 15 December can be downloaded here or opened in PDF format here:

PDF: Minutes CFS/ME Expert Group Meeting 15 December 2008

Document Library
CFS/ME Expert Group meeting – 15 December 2008
Issued: 15 Dec 2008
Primary audience: Researchers
Document Summary

Agenda and minutes from the 1st meeting held on 15 December 2008

 

The list of members can be opened in PDF format here:

PDF: CFS/ME Expert group membership

Term of Reference can be opened in PDF format here:

PDF: Finalised Terms of Reference for CFS/ME expert group

or go to MRC site for full article and files:

Chronic Fatigue Syndrome/Myalgic Encephalomyelitis 

( http://www.mrc.ac.uk/Ourresearch/ResearchFocus/CFSME/index.htm )

ME Association: Summary Board of Trustees meeting 7, 8 September 09

A meeting of the ME Association Board of Trustees was held on 7 and 8 September:

From the ME Association News page

Summary of MEA Board of Trustees meetings held on 7th and 8th September 2009

This is a summary of key points to emerge from two meetings of The ME Association Board of Trustees. These meetings took place at our Head Office in Buckingham on Monday afternoon, September 7th 2009 and on Tuesday morning, September 8th 2009. Informal discussions also took place on a number of issues on the Monday evening. Part of the Editorial team for the magazine discussed the content for the November issue on Tuesday afternoon.

Please note that this is a summary of the Board meetings – not the official minutes. The order of subjects below is not necessarily in the order that they were discussed.

PRESENT

Trustees:

Ewan Dale (ED) – Honorary Treasurer
Mark Douglas (MD)
Neil Riley (NR) – Chairman
Charles Shepherd (CS) – Honorary Medical Adviser
Barbara Stafford (BS) – Vice Chairman

Officials:

Gill Briody (GB) – Company Secretary
Tony Britton (TB) – Publicity Manager

Apologies:

Rick Osman (RO)

FINANCES

ED updated trustees on the current financial situation. Trustees then discussed the monthly accounts for the period up to the end of July 2009. Income for general funds continues to remain roughly in line with expenditure for the first seven months of the year – although the interest rate on our main reserve fund is protected from the full impact of the collapse in rates until November 2009. So we appear to have deferred the worst effects of the recession – at least for now. Trustees made some further minor changes to banking arrangements in order to maximise interest rates on the various bank balances.

MRC publishes Minutes of 1st “CFS/ME Expert Panel” meeting

The names of the members of the MRC CFS/ME Expert Group, the Panel’s Terms of Reference, the Agenda and Minutes of the meeting held on 15 December 2008 and other information has finally been published on the MRC’s website.

The list of members’ and the Panel’s Terms of Reference were previously obtained under FOIA and published here on ME agenda.

The Agenda and Minutes of the meeting on 15 December can be downloaded here or opened in PDF format here:

PDF: Minutes CFS/ME Expert Group Meeting 15 December 2008

Document Library
CFS/ME Expert Group meeting – 15 December 2008
Issued: 15 Dec 2008
Primary audience: Researchers
Document Summary

Agenda and minutes from the 1st meeting held on 15 December 2008

 

The list of members can be opened in PDF format here:

PDF: CFS/ME Expert group membership

Term of Reference can be opened in PDF format here:

PDF: Finalised Terms of Reference for CFS/ME expert group

or go to MRC site for full article and files:

Chronic Fatigue Syndrome/Myalgic Encephalomyelitis 

( http://www.mrc.ac.uk/Ourresearch/ResearchFocus/CFSME/index.htm )

Chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME) is a complex and debilitating condition with a diverse range of symptoms. Profound physical and/or mental fatigue is the most well-known, while others include pain, disturbed sleep patterns and gastrointestinal problems. Each patient experiences their own personal combination of symptoms.

Research Strategy
MRC CFS/ME Expert Group
Terms of reference
Previous MRC activities
Current MRC-funded research projects
How does the MRC decide which research proposals to fund?

Research Strategy
CFS/ME is currently a highlighted area, and is an area that is of high priority for the MRC. In 2008 the MRC set up a new group to consider how the MRC might encourage new high-quality research into CFS/ME and partnerships between researchers already working on CFS/ME and those in associated areas This work follows on from the Research Advisory Group set up in 2003 and the joint workshop held with Action for ME in 2006.

MRC CFS/ME Expert Group
The Group is chaired by Professor Stephen Holgate, chair of the MRC Population and Systems Medicine Board and brings together leading experts in the CFS/ME, from associated fields that may be involved in the underlying mechanisms of CFS/ME and from the charity sector:

Professor Stephen Holgate – University of Southampton – Chairman

Professor Jill Belch – University of Dundee

Dr Esther Crawley – University of Bristol

Professor Philip Cowen – University of Oxford

Professor Malcolm Jackson – University of Liverpool

Dr Jonathan Kerr – St George’s University of London

Professor Ian Kimber – University of Manchester

Professor Hugh Perry – University of Southampton

Dr Derek Pheby – National CFS/ME Observatory

Professor Anthony Pinching – Peninsula Medical School

Dr Charles Shepherd – ME Association

Sir Peter Spencer – Action for ME

Professor Peter White – Bart’s and the London School of Medicine and Dentistry

The aim of the Group is to look at new ways of encouraging new research in the CFS/ME field not only by looking at new technologies but also at associated areas that could help inform on the diverse range of symptoms and possible underlying causes of CFS/ME.

The terms of reference of the Group can be found below.

Terms of reference

1. To consider and review the status of current research in CFS/ME.

2. To consider the underlying mechanisms and sub-phenotypes of CFS/ME.

3. To identify research opportunities incorporating new technologies and conjoint areas and encourage new research towards understanding the basis of CFS/ME.

4. To produce a framework for conducting high quality CFS/ME research in the future.

5. To work to achieve clear lines of communication and synergy between all stakeholders with an interest in this area.

Notes of the Expert Group meetings can be found following the links below:

1st Meeting of the CFS/ME Expert Group – 15th December 2008
2nd Meeting of the CFS/ME Expert Group – 30th March 2009 (to follow)

Click here to read full MRC information 

MRC CFS/ME Expert Group: Finalised Terms of Reference

MRC CFS/ME Expert Group Finalised Terms of Reference

Since 16 November 2008, I have had a request for information under the Freedom of Information Act outstanding with the MRC for a copy of the Terms of Reference for the “CFS/ME multi-disciplinary Expert Group” chaired by  Professor Stephen Holgate.

The first meeting of the MRC’s “CFS/ME Expert Group” was held on 15 December 2008 and there has been at least one other meeting since then, with a workshop scheduled for November.

I have chased the MRC several times, since December, for this information, and have been advised that although the  panel has met several times, it had yet to agree its Terms of Reference.

Today, I have received a communication from Ms Rosa Parker, MRC Corporate Information and Policy, advising that the panel’s Terms of Reference have now been finalised and attaching a copy, which I append. I am further advised that the Terms of Reference will shortly be published on the MRC’s website at www.mrc.ac.uk

The MRC has yet to publish, on its website, names of the members of this panel. I obtained a list of members, under FOIA, in December 2008.

For the list of panel members see:

http://meagenda.wordpress.com/2008/12/12/foi-request-mrc-cfsme-multi-disciplinary-panel-members-list/

For a report by Sir Peter Spencer (Action for M.E.) following the panel’s inaugural meeting see:

http://meagenda.wordpress.com/2008/12/19/mrc-multi-disciplinary-panel-expert-panel-inaugural-meeting/

 

Fulfilled under FOIA on 11.08.09:

Received from Ms Rosa Parker, MRC Corporate Information and Policy

MRC Expert Group – Final terms of reference   Open PDF:  Finalised Terms of Reference for CFSME expert group

CFS/ME Expert Group

Terms of Reference

1. To consider and review the status of current research in CFS/ME.

2. To consider the underlying mechanisms and sub-phenotypes of CFS/ME.

3. To identify research opportunities incorporating new technologies and conjoint areas and encourage new research towards understanding the basis of CFS/ME.

4. To produce a framework for conducting high quality CFS/ME research in the future.

5. To work to achieve clear lines of communication and synergy between all stakeholders with an interest in this area.

To be published on the MRC website: www.mrc.ac.uk

Ends

RSM “Medicine and me” event: Commentary by John Sayer

Royal Society of Medicine “Medicine and me” event on ME and CFS held Saturday, 18 July 2009

Commentary

John Sayer (Chair, M.E. Support-Norfolk)

25 July 2009

The half-day conference was organised jointly by the Royal Society of Medicine, the MEA, AfME, AYME, the 25% ME Group and TYMES Trust.

The promotional literature informed us that:

“‘Medicine and me’ conferences, initiated and developed by the Royal Society of Medicine, are specifically designed for patients. These meetings bring together patients, their families, carers, advocates, patient support groups, clinicians and researchers to discuss care and research issues in a particular condition…[and]…aim to provide a forum in which patients’ concerns about their illness are given top priority.”

Unfortunately, the pattern of the day – two presentations at a time followed by a five-minute slot for questions – did not really provide for much in the way of patient-led questions and/or discussion. It was, however, an opportunity to see what the various bodies involved had to say for themselves (and encouraging to hear Jane Colby of TYMES Trust underline in her welcome address that the title of the proceedings was “Medicine and me: ME *and* CFS”).

(This write-up is based on notes taken at the time by myself and Gus Ryan.)

Session 1 was chaired by Dr Charles Shepherd (MEA), who reminded us that there had been two parliamentary meetings [i.e. the All-Party Parliamentary Group on ME and the Countess of Mar's ForwardME Group] earlier in the week and that people still had a chance to submit written evidence to the APPGME’s NHS service provision inquiry.

The first presentation, “Diagnosis: the patient’s perspective”, was by Jez Harding (of Jez Harding Consulting Ltd), who had been diagnosed by Leslie Findlay as suffering from “classic M.E.” Jez described the term ‘CFS’ as “useless” and “a generic term”, pointing out that many illnesses had been lumped together. He considers the NICE Guideline to be “a fudge”. He had found his treatment – comprising CBT-style therapy, meditation and an anti-candida-type diet etc. helpful in completing a degree course. He now runs his own business, but has to take things as easy as possible (for example, avoiding the Tube). His GP won’t do anything that isn’t in the NICE Guideline, but *is* willing to refer him to a psychiatrist! He stressed the need for more biological research and wants more intellectual curiosity and cultural change in the approach to M.E.

Dr Abhijit Chaudhuri (of the Essex Centre for Neurosciences) spoke on “A rational, efficient and practical approach to diagnosis”. He said that ‘CFS’ represents a wide group of patients and the term does not help matters; that there should be earlier diagnosis, perhaps three months into illness onset (six weeks where children are concerned). He does not think the NICE Guideline has helped. In his view, post-exertional malaise, muscle cramps and *well preserved motivation and interest* (my emphasis) are key symptoms of M.E. and referral should be to a neurologist, since even psychiatrists admit that roughly 10% of ‘CFS’ sufferers have a neurological problem. He said that we need a national centre and funding for it (Romford being a treatment – not research – centre). His talk ended with a slide presentation of inflammation of the dorsal root ganglion, which he pointed out was “the gatekeeper of sensations”.

In the question slot Ciaran Farrell asked how we could change the NHS – to much applause from the audience. Dr Chaudhuri repeated that we need a national research centre.

“M.E. in children and adolescents” was presented by Shannen Dabson, a teenager whose story struck a particular chord with me as a teacher (prior to M.E.). She has had M.E. for six years, and now has very little trust in adults, having received virtually no respect for herself and her diagnosis. She found herself “written off” by her school, who didn’t send her work, didn’t mark the work she managed to do, didn’t send her the school newsletters or keep her informed of such things as the school photographs (which was the part that had me closest to tears, as I’d suffered the same treatment from my last employer: I will never forgive them for my absence from the school photograph of my form pupils; for both Shannen and me, it was like being airbrushed out of history). Shannen had had to make her own arrangements for taking exams, as her school refused to enter her on the grounds of a poor attendance record. To her admirable credit, she got six GCSEs anyway! I’m hoping to reproduce her talk for “MES-N” members, as it should be inspirational, especially for youngsters. She came up with what I personally consider to be a very practical, appropriate and *scientifically sound* slogan: “Work smarter, not harder!”

Hardip Begol (of the Department for Children, Schools and Families) spoke on “Addressing the educational impact of ME”, and said that Shannen’s situation is all too common from an educational point of view and that it was difficult to make teachers believe in ME/CFS. No personal disrespect to Mr Begol, but it struck me that what he had to say in his presentation did not have all that much immediate relevance, being, as one might expect, current government ‘fudge’. His comments were not actually specific to M.E., but here’s hoping that the conference gave him something to think about and take back to the DfCSF (though I’m not really holding my breath on that one).

In the question slot following these two talks Mary-Jane Willows (of AYME) said that the balance of power was with schools and Jane Colby pointed out that parents are too afraid to complain. (Personal note – no wonder, with the spectre of Social Services waiting in the wings, ready to pounce.)

Catriona Courtier (of the West London M.E. Self Help Group) spoke on “Treatment: the patient’s perspective”. She has had M.E. for twenty six years and her daughter is also ill. She reminded us that an AfME survey revealed that patients received very little proper treatment and that an MEA survey demonstrated that graded exercise therapy (GET) was the most dangerous form. She is ‘anti-NICE’. She said that staff at her local clinic *want* to help – but are misinformed.

Prof Anthony Pinching of the Peninsula Medical School, Plymouth, spoke on “Treatment – evidence-based and pragmatic approaches” and thinks that things are changing for the better. In his view, M.E. is a physical illness with psychological consequences and that people should work together and “not lob bricks at each other”. He said that the Cornwall service does make home visits. He advocates a ’symptom-control’ approach: which symptoms does a patient want most help with? I found him to be a bit vague and general, really, and he seemed to be saying that every individual needs different treatment (including psychological approaches), to be negotiated between patient and physician, and seemed to imply that success depended on the doctor-client relationship (which I personally find a bit too New-Agey: “permission to be ill and permission to have fun whilst you’re ill”). He did, however, say that there is a need for “building M.E. into the medical curriculum” (note – although it depends on exactly *what* is built in!). In response to a question about CBT from Dr Charles Shepherd, he indicated that such treatment should be ‘individualised’.

In the question slot Dr Chaudhuri expressed disagreement with Prof Pinching, saying that patients are *not* listened to and that the NICE Guideline is aimed at a *broad* group – these points being applauded by the audience. Prof Pinching responded that the NICE Guideline is not perfect, but should be used “to best effect”.

After a short (very short!) break, Sir Peter Spencer (Chief Executive Officer, AfME) chaired Session 2.

Dr Neil Abbott (ME Research UK) spoke on “Research: what do patients want and why isn’t it happening?” He suggested that the RSM host a biomedical conference on M.E. (Applause!) He said that the psychosocial model is predominant in the UK, although not quite so much in the US. He quoted Prof Simon Wessely with reference to psychosocial interventions: “certainly, those interventions are not the answer to CFS”. MERUK survey reveals that research on mitochondria, RBCs, immune cells, muscles, blood vessels, genes and brain are wanted; that this is not  “sexy” illness. ‘ME/CFS’ label is a problem: it is a process of elimination and that leads to a dustbin diagnosis. He is critical of the psychosocial approach, which is applicable to *all* illnesses (used to manage symptoms) and not specific to M.E. The real problem, in his view, is lack of funding.

Prof Stephen Holgate (University of Southampton) spoke on “ME: a research orphan for too long”. He said we need research because too little is known [sic] and said that the history of M.E. has dictated a mental health approach, it being perceived as having evolved from neurasthenia ['nervous debility']. He said, “It’s a system disorder” and that ‘omics’ should be used – i.e. genomics, proteomics and metabolomics. He referred to ‘ME/CFS’ as a “condition or conditions (25 or more)”; that the government won’t allow integrated research. He is putting together a workshop in November (the Medical Research Council Interdisciplinary Expert Group on M.E.), a systematic review deciding priorities, saying that a collaborative needs to be formed from charities [sic], the MRC and researchers, and that there is a need to ‘join up’ patients from clinics/centres. [Personal note: it all seemed to me a bit like reinventing the wheel and I have my misgivings about not only which 'charities' will be invited to participate but also the calibre of patients from the clinics/services.]

Dr David Misselbrook (Dean of the RSM) then invited questions to the panel of speakers. An elderly neuroscientist and his grandson tried to deliver a plug for the Lightning Process, the grandson claiming we had “wasted all this time talking when a cure has already been found” [sic], but Dan [from "M.E. Support-Norfolk"] pointed out that we hadn’t come all this way to hear a sales pitch for LP and Jane Colby expressed serious misgivings about success claims, citing an example of further harm caused to a patient; she also pointed out that no one can legally claim recompense if LP doesn’t cure a patient as it is not offered as a treatment, but a ‘training’.

Ciaran Farrell challenged Prof Holgate’s ‘history’ of M.E. but Prof Holgate said he had been misunderstood, that it wasn’t his own belief that M.E. was a form of neurasthenia and that he agreed with Ciaran, adding that he wanted to get rid of the terms “CFS” and “M.E.” [whatever that implies!].

In “Closing remarks”, Mary-Jane Willows said that there should be quick diagnosis, raising of awareness and no “one size-fits-all” approach. Doris Jones (of the 25% ME Group) read out a list of M.E. sufferers who have died and requested a minute’s silence in their memory, which was dutifully observed.

All in all, in my own opinion? A worthwhile day in order to find out what is going on in various quarters, but throughout the proceedings I did wonder who the ‘target audience’ was supposed to be, and for whose benefit this had all been arranged. Was it a ‘box-ticking’, ‘patient consultation’ exercise? The subtitle of the event, “Hearing the patient voice”, was a bit misleading, since we were mostly being talked at, not listened to; there certainly wasn’t enough time, as I said at the beginning, for much questioning or discussion. But maybe some of what was said will pay dividends. Fingers crossed.

John Sayer, Chair
M.E. Support-Norfolk

————————-

Ed Notes:

1] Terms of Reference for the MRC’s Interdisciplinary Expert Group on M.E. have yet to be agreed (FOI Act).

2] ME agenda is unable to enter into correspondence around the Lightning Process.

Forward-ME: Minutes of meeting 8 July 2009

Would Dr Esther Crawley like to provide evidence to support this statement?

“Dr Crawley explained that the reputation the CFS/ME charities had for infighting was not particularly helpful and prevented research and clinical involvement.”

In February, this year, Dr Crawley, who had been a member of the NICE Guideline Development Group, was awarded £730,000 for research into “CFS/ME” and “Fatigue” in children:

http://www.bristol.ac.uk/ccah/news/2008/12.htmldresthercrawley

 

The Minutes of the last meeting of the Forward-ME group, held on Wednesday 8 July at the House of Lords, have now been posted on the group’s website:

This is a caucus group to the APPG on ME convened by the Countess of Mar, last October. Membership of the group is by invitation only; members of the public are not permitted to attend either as participants or observers.

The 25% ME Group had been a member of Forward-ME but has since withdrawn all involvement with the group. 

—————————-

http://www.forward-me.org.uk/8th%20July%202009.htm

FORWARD-ME

Minutes of the meeting held on Wednesday 8 July 2009 at the House of Lords

1. Present: Christine Harrison – BRAME

Bill and Janice Kent – ReMEmber

Jane Colby – TYMES Trust

Peter Spencer – AfME

Charles Shepherd – MEA

Mary-Jane Willows – AYME

Margaret Mar – Chairman

 

2. Apologies: Tanya Harrison – BRAME

Sue Waddle – MERUK

Kathleen McCall – Invest in ME

 

3. Minutes of the Meeting held on 21 April 2009:

The minutes of the meeting were agreed and signed by the Chairman.

4. Dr Esther Crawley, FRCPCH; PhD, Senior Lecturer at the University of  Bristol and a Consultant Paediatrician, Chair of the CFS/ME Clinical  Research Network Collaborative (CCRNC)

and

Dr Hazel O’Dowd, MSc, D Clin Psych, Consultant Clinical Psychologist, Clinical Champion for CFS/ME services for Avon, Gloucester, Wiltshire and Somerset:

The Chairman introduced Dr Crawley and Dr O’Dowd and thanked them for coming to address the Group.

Dr Crawley gave a PowerPoint presentation a copy of which she kindly agreed to send to us after the meeting (see Presentations )

http://www.forward-me.org.uk/Presentations.htm 

Click the link to open/save the file depending on your browser

CFS/ME Clinical and Research Network and Collaboration by Esther Crawley – PowerPoint Show file

http://www.forward-me.org.uk/Presentations/forwardME_no_photos.pps  (Ed: MS PowerPoint or compatible reader required)

She explained that there were historical issues that had resulted in mistakes being made over patient participation. She had fought for patient/carer involvement and, by the time of the next CCRNC executive there will be 8 patient/carer representatives (4 from charities) on the Executive committee.

The National Outcomes Dataset (NOD) is an essential tool for providing evidence for further research into causation and treatments.

There are many strengths upon which the CCRNC intends to build. Openness and their recognition of the importance of working together has already attracted MRC, NIHR and Welcome support. The list of current research studies currently being carried out by members of the CCRNC was extensive and covered many medical specialisms.

Provision of services was a serious weakness, especially where children were concerned. Most children did not even get a diagnosis; there was no domiciliary provision for them as, indeed, there was not for most adults who are seriously affected. There was, historically, a lack of patient involvement.

Opportunities for progress were opening up with the ability to do large-scale research on cohorts of 3,000 patients. There was no other comparable large scale cohort in the world.

An open approach which looked at both good and bad results was essential if improvements in care, data collection and sharing, and the ability to apply political pressure were to be achieved.

Dr Crawley explained that the reputation the CFS/ME charities had for infighting was not particularly helpful and prevented research and clinical involvement.

The meeting was opened to questions. Janice Kent asked whether the Genome Wide Association Studies were linked to the genetic research conducted by DR Jonathan Kerr. Dr Crawley explained that his work involved gene expression – how the genes function. This generated hypotheses for further investigations. The results could be altered by effects secondary to the illness – by alcohol, drugs or exercise, for example. Genome-wide association studies involved scanning the DNA of a large cohort of patients to find common genetic variations associated with illnesses which would enable researchers to detect, treat and prevent diseases.

Charles Shepherd asked whether, in the light of the widespread opposition to the NICE Guidelines, charities that were opposed to them would be invited to become members or associates of the CCRNC executive. Dr Crawley acknowledged that, whilst the NICE Guidelines were flawed, they were a start. There was a need for all to work together to produce evidence to effect a change in the guidelines. In order to join the collaborative, charities would be expected to sign up to the evidence based approach. It would be a matter for discussion.

Janice Kent asked about charities and groups that had been excluded from formal representations to the specialist clinics when they were being set up. She explained that they had a wealth of information and experience. Dr Crawley said that the CCRNC want to work with everyone concerned and ask Janice to write to her with the detail.

Christine Harrison asked about coverage by the CCRNC. She explained that the east of England had no specialist services at all. Dr Crawley agreed that provision for most areas was thin. The original budget had been for about £100,000 for each clinical team. To be assessed as cost effective, this would treat 100 patients. Some regions were dealing with 300 patients on this budget. There was a very real need for effective local services.

Christine asked about the grading of patient evidence as NICE had given the very large amount of evidence it received the lowest grading. Dr Crawley acknowledged that the method for grading was imperfect. Patient experience was valuable and should inform high quality research, opening the door to further research.

Jane Colby asked about the rationale of treatments offered for different aetiologies of CFS/ME. Dr Crawley explained that with an illness like CFS/ME which is a heterogeneous disorder there were differences between what was observed clinically and what was shown biologically. She cited schizophrenia and bipolar disorder, which were thought to be separate illnesses but are the same on genome wide association studies. There was a need for caution as not enough was known. In her clinics, patients were offered a variety of options which were individualised. If they made a wrong choice another option would be sought. There is currently no evidence of what will work for different subgroups. Jane asked about return to school. Dr Crawley said that she listened to her patients and helped them to achieve what they thought they could do, whether it was to improve their athletic performance, socialising or education, for example.

Peter Spencer commented on several of the points raised including analysis of data, measurements of effectiveness, benchmarking and people wanting to work with and learn from each other. There was a need to concentrate research resources. Greater patient involvement was key. There was no obligation on PCT’s to take the severely affected into account. The severely affected were particularly neglected; they had no voice and it was not surprising that they were particularly frustrated.

Charles Shepherd commented on the fact that those with the greatest need were given the lowest priority. Dr Crawley suggested a solution would be for them to use the NICE Guidelines which state that the severely affected have the right to have an immediate domiciliary visit and access to all services. If there were no specialists in their area they should ask for an out of area referral. These were costly and, if used enough, local services would be provided on cost grounds. It was not good practice to expect severely affected children and adults to travel long distances for consultations or for physicians to travel to make domiciliary visits. The situation was gradually improving, but effective outcomes were still a drop in the ocean compared with the unfulfilled need.

Dr O’Dowd spoke about training, for which she is responsible within the CCRNC. She accepted that it was not perfect. In 2003 she had to establish training for the first wave of teams with national training for the new clinicians. The DoH mandate was to improve diagnosis by GP’s. This was improving very slowly. Initially, when they set up training courses, only a few interested GP’s attended. It was difficult to attract those who were sceptical about CFS/ME. They then attached training to the end of other events that were more attractive to GPs. There were also local GP training schemes happening in a piecemeal way. They wanted to get CFS/ME on the core curriculum for medical, physiotherapy and occupational therapy training. This was difficult, but there were some successes. She acknowledged that there were regional variations. In some places there was a high staff turnover for specialist services. They were developing the workshops. Additionally, over the next 2 years they hoped to develop an on-line training package that would be easily accessible. Working with the CCRNC had been beneficial as the trainers could have access to a large body of training material from the regions which cut down their workload.

Speaking personally, she said that there was much less scepticism about CFS/ME amongst the people she worked with. She had seen a marked change in her day to day dealings with doctors and other health care professionals. She felt that it was essential that the GP, district nurse and other members of the primary care team should always be involved in home visits. The most successful encounters were those that occurred on a one-to-one basis.

Margaret Mar asked how Dr O’Dowd would address the charge of a lack of balance between the psychological and the biomedical models of the illness at the April meeting of the CCRNC. She said that, after her experience of working with patients with other chronic conditions such as cancer and arthritis, she had been surprised to find that this was an issue with CFS/ME. She had not had any personal problems with it – in fact she found that sufferers have broader minds that many with other illnesses, possibly because they had been so neglected and forced to fend for themselves. The April conference had been full of variety, with lots of biology, but she accepted that they did not get it right. There was a problem in that many invited speakers, whose contributions were valuable, would not attend or would not agree to their papers being made public because they were wary of criticism.

Charles Shepherd asked whether the CCRNC had a view about causation, particularly the roll of deconditioning and abnormal illness behaviour. Dr O’Dowd said there was no overall view as there was no defined causation and the processes were not yet understood. This should not stop people being helpful. Patients understood well what affected them and any fitness programmes were developed jointly with the patient. Very few could be described as deconditioned.

Mary-Jane Willows commented that there was ‘no one voice’. If everyone did the same there would be no learning. Models of service were one of the factors in terms of outcomes.

Janice Kent asked about adverse effects from participation in the PACE trial. She described what had happened to a particular patient from her group, she was advised to obtain the patient’s permission and to feed back to the PACE triallists. It was essential that they were aware of bad results as well as good ones. Dr Crawley pointed out that all treatments have some side effects and that it was important to find those that worked for individual patients.

Christine Harrison asked whether CCRNC had a website. She commented on the lack of any services in East Anglia and asked whether they used patients in their training sessions. She also asked whether CFS/ME should be included in neurology training. There was no dedicated CCRNC website. As CFS/ME was bigger than just neurology, it was not thought appropriate to confine it to ‘one box’. The lack of GP services meant no home visits. As a result, there was an unknown number of patients who had fallen off the radar of NHS care. Unfortunately, there were not enough resources to cover every contingency and it was impossible to train GPs who do not want to listen.

Peter Spencer echoed the need for training and commented on the variations in awareness of CFS/ME. *He understood that Dr Miller of Liverpool University had developed a training module on CFS/ME for the Royal College of physicians. The workshops at the April conference had involved professional workshops and good interaction. Assumptions about the agenda for the conference were, unfortunately, based on assumptions about where speakers came from rather than facts based on what they actually said. AfME was associated with PACE and had been pleased by the very low drop-out rates. He agreed that adverse effects should be reported. There was a need to reconcile evidence of NHS providers with patient surveys on outcomes and to question the differences. In so far as GET was concerned, there was a need to look at the detailed evidence with clinicians. For example, he asked whether it was proper GET. Were randomised control trials appropriate for long-term, chronic conditions such as CFS/ME? He agreed that evidence based principles were essential.

Charles Shepherd asked whether there were exclusion criteria as he had a case where a patient had been excluded on grounds of obesity. Dr Crawley said there was no central policy. She screened her patients because there were other causes of fatigue and she had found one child with undiagnosed leukaemia. She could not judge decisions made by other clinicians.

5. **Lightning Process:

Charles Shepherd had been made aware of a meeting which was to take place at University College London in conjunction with Great Ormond Street Hospital which appeared to promote the Lightning Process for patients with CFS/ME. As Dr Crawley knew something about the subject, she was asked to remain and to contribute to the discussion. Of particular concern was the promotion of the programme to vulnerable clinicians who had just started to practice. After some discussion about the pros and cons of the programme, it was agreed that Mary-Jane Willows would talk to the organisers on behalf of Forward-ME highlighting our concerns.

6. APPG Inquiry:

As this had been discussed at the APPG meeting that took place immediately before the Forward-ME meeting, it was agreed that there was not much more to be said, though there were concerns about delays and the incomplete coverage of prospective witnesses with questionnaires.

7. MRC Project:

***Charles Shepherd reported that the latest information was in the MEA magazine and on their website.

8. Any Other Business:

Margaret Mar reported that she had had an interesting meeting with Dr Wendy Ewart, Director of Strategy for the MRC. She was interested to work with us and to meet the CCRNC team.

Following a letter from InvestinME [sic] in which the difficulties of working with charities and groups who were not of the same mind on particular matters, Margaret Mar had written to them asking whether they wished to continue with their membership of Forward-ME. This would be discussed further at the next meeting.

There being no further business, Margaret Mar thanked Dr Crawley and Dr O’Dowd for their very full presentations and for their candid responses to our questions. She hoped that they would both agree to continue to work with Forward-ME.

9 Date of Next Meeting:

To be advised.

——————-

*Dr Alistair Miller was a presenter at the Royal Society of Medicine “Chronic Fatigue Syndrome” Conference on 28 April 2008:

Download Abstracts and Biographies [PDF 86k]
http://www.rsm.ac.uk/chronicfatigue08/abs.pdf

What drugs can I use? [PDF 243k]
Dr Alastair Miller, Royal Liverpool University Hospital
http://www.rsm.ac.uk/chronicfatigue08/moss_miller.pdf

What drugs can I use? Dr Alastair Miller
http://rsm.mediaondemand.net/player.aspx?EventID=1337

**Please note that ME agenda is unable to enter into correspondence around the Lightning Process.  Please direct any enquiries regarding the content of these Minutes to the Chair of Forward-ME.

***Refers to the MRC CFS/ME multi-disciplinary panel chaired by Prof Stephen Holgate.  Although the group has held several meetings, the group’s Terms of Reference have yet to be agreed and published (FOI Act).