Category: MRC

Summaries: MEA Board of Trustees meetings 6th and 7th of September 2010 and AGM

Summaries of ME Association Board of Trustees meetings held on 6th and 7th of September 2010 and AGM (Annual General Meeting) held on 7th September

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

New MEA website link for these Summaries:

http://www.meassociation.org.uk/?p=1659

Summary of MEA Board of Trustees meetings held in September 2010

This is a summary of key points to emerge from two routine meetings of The ME Association Board of Trustees.These meetings took place at our Head Office in Buckingham on Monday afternoon, September 6 and on Tuesday morning, September 7 2010. 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.

Where appropriate, there is background information relating to the issue being discussed.

The final part of the summary also contains key points from the AGM held on Tuesday afternoon, results of trustee elections, and the post AGM Board of Trustees meeting.

PRESENT

Trustees:

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

MEA Officials:

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

Apologies:

Rick Osman (RO)
Janet Thomas (JT)

FINANCES, ADMINISTRATION, PREMISES AND STAFF

ED updated trustees on the current financial situation. This was followed by a discussion on the monthly management accounts for the period up to the end of July 2010. There has been a continuing drop in some areas of income during the first seven months of 2010 when compared to the same period in 2009 – unrestricted donations and bank interest in particular. As a result, general expenditure is still running slightly ahead of unrestricted income.

Income from fundraising has shown a continuing and welcome increase over the same period in 2009. In order to cope with the increased demand on fundraising support services a new part-time post to deal with fundraising administration has been created. Applications for the new post are now being considered.

There has also been a significant increase over the past seven months in the ring-fenced funding held by the Ramsay Research Fund.

Trustees reviewed the changes in banking arrangements, aimed at improving interest received on deposit accounts, that have been carried out in the past few weeks in relation to both unrestricted general funds and restricted research money held in the Ramsay Research Fund.

Trustees held a further short discussion on some possible changes to The MEA Memorandum and Articles of Association to take account of expected new charity legislation.

Trustees passed on their best wishes to Lucy Kingham at Head Office – who is taking maternity leave in September – and finalised arrangements for a temporary member of staff to cover her absence.

MEA TRUSTEES

Trustees had intended to spend part of Monday afternoon interviewing a potential new trustee but he was unable to attend. This interview was therefore postponed to a later date.

As reported previously, Janet Thomas had to withdraw from the 2010 trustee election due to ill health but will remain as an observer. It was agreed that she has been an excellent trustee and it is hoped that she will re-apply if her health improves.

We are still able to increase the number of co-opted trustees – so we are keen to hear from anyone who would like to discuss the possibility of joining the MEA in this role. Applications are welcome from people with ME, carers, and anyone who has a skill which they feel could be of benefit to the charity. In order to proceed with an application, non- members would have to become members of the MEA.

FORWARD PLANNING

A further short discussion on the future growth of the MEA was held on Tuesday. This work includes the expansion of the services we already provide and new services that we would like to provide if/when the financial situation allows us to do so.

FUNDRAISING INITIATIVES

The MEA has to raise funds on top of membership subscriptions, which currently only provide around half of the general income that is required to fund the basic running of the charity and Head Office administration. We are also facing a situation whereby people are reducing donations to the charity sector. At the same time, demand on support and information services is increasing, especially in relation to benefit and employment information now that the welfare/benefit reforms and difficulties associated with the introduction of the ESA are taking effect. Trustees and staff therefore have to devote a significant part of their time to boosting fundraising activities in order to maintain our current level of services.

Northern Ireland fundraising for ME/CFS research. Mid Ulster Vintage Vehicles Tractor and Car Club: Sponsored trek from Moneymore to Castlerock-Limavady

TB reported on the outcome of the Mid-Ulster Vintage Vehicles Club’s 100-mile vintage tractor and car trek, which this year has raised a substantial sum for the Ramsay Research Fund. The event started in Moneymore on Saturday 23rd July and finished the following day in Castlerock-Limavady. A tremendous effort has been put in by the O’Neil family – father John, sons Ronald and Richard and daughters Jacqui and Fiona. Following a request from the organisers, TB and CS will be travelling to Northern Ireland later this month for the presentation ceremony.

More information on this important fundraising event appeared in the July issue of ME Essential magazine.

2010 London Marathon

The MEA paid for two guaranteed places in the 2010 London Marathon – so we had two runners taking part as well as several other people running who raised money for The MEA. We would welcome offers from anyone who wants to raise funds in 2011 but we are not paying for any guaranteed places next year.

Amazon Walk to raise funds for a tissue and post-mortem/brain bank:
BS reported on the return of her son Ed, following completion of his epic Amazon Walk. Ed has walked solidly for 859 days and covered around 6,000 miles. He is the first person to carry out what has been an outstanding physical and mental challenge and he will quite rightly enter the history book of hazardous expeditions.

On his return in early August Ed appeared on a number of radio and television programmes – including GMTV, BBC Breakfast Time and the BBC One Show – and his story has been given extensive coverage in the UK and international press. A full summary of media coverage can be found on the MEA website news section.Ed’s progress can still be be seen on his Amazon Walk blog >> http://www.walkingtheamazon.com 

Trustees discussed a number of ideas for possible fundraising events following his return home. One of Ed’s first talks on the Amazon expedition will be given to a meeting of the Transglobe Expedition Trust at the Royal Geographical Society in November, where he will be joined by the distinguished explorer Sir Ranulph Fiennes and Michael Palin.

Ed Stafford has a fundraising page for MEA/RRF research here. Around £8000 has been raised so far.

Vegepa for ME scheme The Vegepa for ME Scheme is proud to announce a new partnership with the ME Association’s Ramsay Research Fund to run alongside their long-standing enterprise with ME Research UK in a joint effort to improve the lives of ME sufferers. From August 2010, The Scheme, which has donated over £36,000 since it started up in 2006, will be raising money for crucial biomedical research undertaken by both of these ME charities. The Vegepa for ME Scheme, devised and run by Lynne Kersh, mother of a daughter with long-term ME, has a secure website which sells clinical-grade, patented Vegepa and its various sister products.

MEA website shopping  This facility on the MEA website home page provides a direct link to well known shops and on-line stores. Purchasing goods on-line from companies such as John Lewis, M&S, and Amazon via the MEA website is simple and we receive a commission of up to 15% from the shop at no charge whatsoever to the purchaser. Please give it a try! It only takes a few seconds to register for the service on the Easyfundraising.com website.

Mobile phone and ink cartridge returns and trolley coins MD reported on the latest financial returns from these on-going fundraising initiatives. Returns of ink jet cartridges continue to be a very successful source of income – so please keep sending them in. Trolley coins can be ordered using the pdf ORDER FORM on the MEA website: http://www.meassociation.org.uk, or the literature order form insert in the August issue of ME Essential magazine, or by phoning MEA Head Office on 01280 818964/818968. Envelopes for the return of ink cartridges and mobile phones can be ordered using the literature order form.

Christmas cards We have three cards for sale this year – details and pictures in the October issue of ME Essential magazine. A pdf order form can be downloaded the MEA website by clicking here.

Blue ribbons for ME Awareness These can be obtained using the pdf Order Form on the MEA website. Single ribbons cost £1 with a discount for bulk orders over 20.

Summer Raffle This was drawn at the end of July and the winner of the first prize kindly sent the same amount back to the MEA!

Fundraising information Fundraising leaflets are available for use at events and for approaches to sponsors and requests for donations. Free copies can be obtained by phoning MEA Head Office on 01280 818968.

PARLIAMENTARY MATTERS

APPG CS updated trustees on events that had taken place to set up a new APPG on ME following the General Election. This involved finding a new Chairman because Dr Des Turner had retired at the election, as well as finding a small group of other parliamentarians willing to take up the post of Treasurer, Secretary etc.

An inaugural meeting was held on 8 July – shortly before Parliament broke up for the long summer holidays. Those present agreed that David Amess MP would take on the role of Chairman. Other officers elected: Annette Brooke MP (Vice Chair); John Leech MP (Secretary) and Martin Vickers MP (Treasurer). A copy of the Minutes for this meeting can be found in July ME Essential magazine and on the MEA website. The current list of members of the new APPG can be found here.

A planning meeting was proposed for September but no date has yet been fixed.

Further details of the agenda, time, venue for the next full APPG will appear on the MEA website as soon as they become available. It is advisable to check with the MEA website the day before APPG meetings in case any late changes are made.

Neil Riley, Chairman of the MEA, wrote to Dr Des Turner to express our thanks for chairing the APPG and wishing him a happy retirement from Westminster.

The August MEA website poll asked people what they felt was the most important topic for the new APPG on ME to take on. Votes were as follows:

XMRV: 913
Benefits: 442
Medical Education: 274
MRC research: 100
NHS Services: 78
NICE guideline review: 74
Severely affected: 47
Children: 15
None: 7

These results have now been forwarded to David Amess, along with a summary of recent developments relating to benefits, research, NICE guidelines, Lightning Process research etc.

APPG Inquiry into NHS Services Trustees previously agreed to help fund the production of some paper copies of the report because we believe this information should be readily available to members of the public who do not have internet access. A paper copy of the final report has been added to the MEA literature list (as a free item) in ME Essential.

The report can also be downloaded from the MEA website or the APPG website: http://www.appgme.org.uk

Countess of Mar’s Group: FORWARD ME The meeting planned for Wednesday 7th July, at which the group intended to discuss a range of current issues, had to be cancelled due to the Countess of Mar being unwell. A new date has not yet been arranged for this meeting.

The Forward ME Group website >> http://www.forward-me.org.uk has information about the group and archives of minutes from past meetings, including a detailed summary of the presentation on benefit issues (ICB and ESA in particular) from Dr James Bolton, Deputy Chief Medical Adviser at the DWP, to the last meeting.:

BENEFITS

Trustees discussed the current situation regarding benefit problems, the changeover from ICB to ESA starting in October, and the Independent Review of the WCA. A copy of the MEA submission to this review can be found on the MEA website here.

NICE GUIDELINE REVIEW

CS reported on correspondence with NICE regarding the date of the proposed guideline review. A copy of our most recent reply from NICE dated 23 August can be found on the MEA website here.

RESEARCH AND RAMSAY RESEARCH FUND (RRF)

RRF: XMRV and MLV: Trustees discussed the latest XMRV research results from validation studies that have been reported in the medical journals – in particular the results from the study by Lo et al that supports a link between retroviral infection (XMRV or MVL) and ME/CFS. The MEA summary and statement on this paper can be found in the website news section here.

The role of the MEA Ramsay Research Fund in supporting UK research groups who want to try and replicate/validate the American findings, or do other relevant work on XMRV was discussed. CS reported on the various contacts and discussions he is continuing to have with virologists on how best to take this research forward in the UK – including the current initiative to retest anyone here in the UK who has sent a blood sample to the US laboratory. The MEA has issued regular website position statements on XMRV and will continue to do so. We have also written to Sir Liam Donaldson, the previous Chief Medical Officer at the Department of Health, about the XMRV research findings and the implications for blood donation and blood transfusion. We have now written to Dame Shirley Davies, the new acting CMO, about extending the blood donation ban to people who have recovered from ME/CFS. A reply from the new CMO states that the current ban will be extended to include anyone with a past history of ME/CFS as from 1 November. This will cover the whole of the UK.

CMO correspondence.

RRF: Professor Julia Newton et al, University of Newcastle CS reported that assessments have been performed on 25 subjects who have been recruited via the Northern Regional ME/CFS Clinical Service. The initial assessment procedures include testing autonomic nervous system function, muscle performance, exercise physiology and body composition (ie the amount of fat and muscle present). The next phase of the study will involve the use of magnetic resonance spectroscopy to assess the way in which their muscle is producing energy and lactic acid. Further information on this study can be found in the August 2009 issue of ME Essential magazine.

RRF funding = approximately £13,800.

Newcastle University Fatigue Research Symposium: Dr Shepherd met Professor Newton at this research meeting which was held on Thursday 10th June at the University of Newcastle. There were presentations from Professor Newton and colleagues on muscle and autonomic dysfunction research involving people with ME/CFS. The meeting focussed on muscle research and considered the role of fatigue in other medical conditions such as HIV and other infections, mitochondrial myopathies, primary biliary cirrhosis and Sjogren’s syndrome. The session on HIV and fatigue covered the important issue of muscle mitochondrial damage following antiretroviral therapy (AZT) and this is obviously going to be very relevant if it turns out that XMRV or MLV is a causative factor in ME/CFS and clinical trials involving antiretroviral therapy take place. A summary of the Newcastle meeting is available in the July issue of ME Essential magazine and on the on the MEA website here.

An abstract from a new research paper from Professor Newton’s research group, which relates to an investigation into cardiac (heart) and skeletal muscle can be found on the MEA website here:

RRF: Factors involved in the development of severe ME/CFS The results of this questionnaire based research, carried out by Dr Derek Pheby and Dr Lisa Saffron, and funded by The ME Association, have been published in an open access on-line journal. More information, including a link to the paper, can be found on the MEA website here.
There is a vast amount of useful information in this paper for anyone with severe ME/CFS, especially those who are involved in disputes over benefits, social care etc.

RRF funding = approximately £30,000.

RRF: Gene expression research Results from a study into gene expression carried out by Professor John Gow and colleagues in Glasgow, and funded by the RRF, were published in the open access scientific journal, BMC Medical Genomics.

Although RRF funding has now finished, we remain in contact with Professor Gow and colleagues in Glasgow regarding further work in this important area.

RRF funding = approximately £38,000.

RRF: Post-mortem tissue bank feasibility study CS updated trustees on phase two of the feasibility study into the setting up of an ME/CFS brain and tissue bank. This has included a focus group meeting which allowed a group of people with ME/CFS to freely express their views on the various ethical, legal and practical issues surrounding tissue and post-mortem research. Work on phase two commenced in February and is being carried out by Dr Luis Nacul and colleagues at the London School of Hygiene and Tropical Medicine. An article summarising all the various MEA post-mortem research initiatives that are taking place can be found on the research section of the MEA website. An article on phase two of this research appears in the February 2010 issue of ME Essential.

Trustees also discussed the various post-mortem research examinations, along with plans for publication, that we have been involved with. CS reported that results from four post-mortems will be presented and discussed at an international conference later in the year.

The next meeting with the researchers involved will take place on September 9th.

RRF funding = approximately £14,000.

ME Observatory Steering Group The final stages of this work are proceeding to plan with several research papers being prepared or submitted for publication. The last MEO meeting discussed the various options for continuing some of the key work being done by the MEO – the Disease Register in particular – when Lottery funding ends in September. The Disease Register now has around 500 people with well characterised ME/CFS – new cases recruited from primary care and others with chronic severe disease via the CHROME database – and it is hoped that this important work will continue and be of use to the researchers in due course.

The ME Observatory has arranged a half day Dissemination Conference that will also cover issues relating to work, welfare and DWP benefits. This event has CPD (continuing professional development) accreditation and will take place in London on Saturday afternoon, 25th September. A senior person from the DWP that deals with ESA will be giving one of the presentations at this event.

Two MEO workshops will be taking place on 28 September (in Sheffield) and 29 September (Birmingham). The next MEO Steering Group meeting will be held on September 9th.

Medical Research Council (MRC) Expert Group on ME/CFS Research Two follow up meetings relating to the two day research workshop that was held on November 19th and 20th 2009 have been held. The minutes of the last meeting, which outlines priorities identified for MRC funded research, can be found on the MRC website. Summaries of the presentations and slides used at the November workshop are available on the MRC website. Further information on the MRC Expert Group can be found on page 12 of the May issue of ME Essential and on the MEA website here.

We are now awaiting a statement from the MRC as what action they propose to take on the recommendations for research priorities that have been made by the Expert Group.

Lightning Process Trustees held a further discussion on a new research study that has been announced into the use of the Lightning Process. Costing £164,000, the feasibility study will investigate how children and adolescents could be involved in a randomised controlled trial that will assess the Lightning Process and compare it to specialist medical care. Not surprisingly, a number of concerns have been raised about the possible use of children and adolescents in this type of study and we are discussing this with our colleagues in other ME/CFS charities. As a result of these discussion the MEA and the Young ME Sufferers Trust (Tymes Trust) issued a joint statement of concern, which can be found here.

This was sent to the Department of Health with a request that it should be forwarded to the ethics committee that is dealing with the application. The DoH have refused to do so – a decision which we believe is unacceptable.

FINE AND PACE Trials Responses to publication of the results from the FINE trial have appeared on the BMJ website, including one from The MEA. Trustees discussed the way in which results from the MRC funded FINE and PACE trials are likely to affect a review of the NICE guideline on ME/CFS. Responses to the results of the FINE trial can be accessed via the MEA website here.

We understand that results from the PACE trial will be reported to the BACME conference in October.

Biochemical and Vascular aspects of paediatric CFS

Trustees briefly discussed the University of Dundee research findings relating to infection and inflammation in children with ME/CFS that had received widespread media publicity on the BBC on Tuesday morning. CS also did some BBC interviews during the day, including Radio 5 Live during their lunchtime news programme. More information on this research can be found on the MEA website.

Sleep Disorders Conference CS has been invited to attend an important clinical and research conference in London in December that will be discussing all aspects of sleep disorders.

*
The MEA is now in a position to fund new research in addition to current commitments and the funding that has been set aside to help set up a UK tissue and post-mortem bank. Information on the work of the RRF can be downloaded from the research section of the MEA website.

SCOTTISH MATTERS

ED reported on publication by the Scottish Health Department on 1 September of clinical guidance on ME/CFS for doctors in Scotland – a document that had originally been based based on the MEA purple booklet for health professionals: ME/CFS/PVFS: An Exploration of the Key Clinical Issues. Publication of the Scottish Public Health Network Needs Assessment has not yet taken place As noted in previous MEA Board meeting reports, the timescale for both projects had to be re-organised in 2009 and progress has been considerably delayed as a result.

Trustees discussed the content of the Scottish Good Practice Statement and the feedback so far from patient representatives that have been involved in their development. A preliminary MEA statement can be found on the MEA website here.

ED will be attending a meeting of the Cross Party Group committee on Wednesday 8th September and the full meeting of the CPG on Wednesday 22 September where the documents will be discussed.

MEA ANNUAL MEDICAL MEETING IN CARDIFF

Trustees finalised arrangements for our annual medical meeting. This is an open and free meeting in an ‘ME Question Time’ format that we rotate around the country. Panel members will be Jane Colby (Tymes Trust), Sue Luscombe (Dietician), Neil Riley (Chairman, MEA), Dr Charles Shepherd (Hon Medical Adviser, MEA) and Dr Nigel Speight (Hon Paediatric Adviser, MEA). This year we are co-operating with the Welsh group WAMES and holding the meeting in Cardiff on Saturday 23rd October. More information can be found on page 3 in the July issue of ME Essential magazine or on the MEA website.

If any local groups are interested in co-hosting this meeting in 2011 please let us know.

MEA LITERATURE

The latest MEA Management File on Fatigue (involving both brain and muscle) appears in the July issue of ME Essential. A new Management File on the subject of XMRV and MLVs is now being prepared for the October issue of ME Essential.

An updated leaflet on dental anaesthetics has been prepared by Dr Richard Cantillon, our dental adviser.

The MEA now has almost 70 leaflets and booklets covering all aspects of research, diagnosis and management.

The MEA Management Report contains the final analysis of data from around 3500 on-line questionnaires and 750 paper questionnaires. The overall response makes this the largest ever survey of patient and carer opinion about management issues that has ever been undertaken here in the UK, possibly in the world. The report was distributed free as part of the May issue of ME Essential. It can also be downloaded from the MEA website – where over 3,000 people have already viewed the report. Extra paper copies can be obtained from the MEA at a cost of £2.50p. This research was funded by the Ramsay Research Fund – so any profits will go to the Ramsay Research Fund.

The October 2009 version of ME/CFS/PVFS – An Exploration of the Key Clinical Issues is continuing to be well received. This 36 page booklet for both doctors and people with ME/CFS contains references to all new research and treatment developments up to October 2009, including a prominent boxed section on the XMRV research findings. The MEA medical guideline is therefore the only substantial publication of this nature covering research, clinical assessment and management to also include XMRV research. As before, The MEA is willing to make a reduction in price for bulk orders from local groups, other ME/CFS charities and PCTs.

MEA literature can be obtained using the website pdf ORDER FORM or the 8-page order form insert in the July issue of ME Essential magazine, or by phoning Head Office on 01280 818064/818968.

MEA WEBSITE

Trustees discussed various matters relating to The MEA website.

The regular on-line survey feature remains very popular. Previous polls have asked about attitudes to post-mortem research (February 2009); GP skills and knowledge (March 2009); how much people have spent on services/treatments outside the NHS (May 2009), Vaccines as trigger factors (May 2010)and opinions on DWP medical assessments that have been carried out by ATOS. The current (September) question asks for opinions on how employers view ME/CFS . Results from all the previous on-line surveys can be found on the MEA website.

If anyone has any suggestions for future website polls please let us know.

ME CONNECT

Trustees reviewed the administration of telephone calls and emails received by ME Connect, our information and support service. Up to the end of July 2010 the service dealt with 1151 emails and 1727 phone calls – a total of nearly 3000 enquiries so fat this year. A recent check on telephone response times audit indicated that almost all calls were being answered either immediately or within a few minutes. However, there will always be occasions when a delay is inevitable due to the volunteer on duty having to deal with a difficult call.

ME Connect, our telephone information and support service, operates every day of the week from 10am – 12 noon; 2pm – 4pm and 7pm – 9pm. Tel: 0844 576 5326.

We are always keen to hear from anyone who would like to join ME Connect as a volunteer. If you are interested please contact the MEA via ME Connect

This e-mail address is being protected from spambots. You need JavaScript enabled to view it.

ME ESSENTIAL MAGAZINE

TB reported on plans for the October issue of ME Essential. Any remaining copy must be with Tony by the middle of September. We are aiming for publication in the middle of October.

The Editorial Board is always happy to receive constructive comments about any aspect of the magazine.

NEW SHORT FILM ON ME : ‘ALL ABOUT ME’

This is a new short documentary film (in two parts) about Laura Fursland, a very promising young music student who developed ME following an episode of glandular fever, with complications, at the age of 18. The film deliberately concentrates on Laura’s story and how it has affected all aspects of her life – in particular how her life is now “on hold” and her plans to go to university to study music.

The medical input – covering key symptoms, possible causation, drug treatments and the losses/social isolation of living with ME at this age – is briefly inserted at various points. The film is not intended to focus on the medical and science behind ME/CFS.

This film was made by Teesside University with information being provided by the MEA.

McCarrickFilms  | 14 August 2010
(Part 1/2) A documentary about M.E sufferer Laura Fursland. A promising young music student…

McCarrickFilms | 13 August 2010
(Part 2/2) A documentary about M.E sufferer Laura Fursland. A promising young music student…

 

MEA HEAD OFFICE: VOLUNTEERS WANTED

In addition to the telephone volunteers who deal with ME Connect enquiries, we have a small number of dedicated volunteers who come into the MEA office in Buckingham on a regular basis to help with various aspects of our work. If you know of anyone who lives locally to Buckingham, and would like to come into the office and help out on a flexible basis please get in touch with Gill Briody. The MEA office is modern, on the ground floor of an out-of-town site, has disabled access, and good free car parking facilities on site.

DATE OF NEXT BOARD MEETING

Fixed for Monday and Tuesday, 15th and 16th November 2010.

AGM AND TRUSTEE ELECTION RESULTS

The Annual General Meeting of the charity took place on Tuesday 7 September at the Head Office in Buckingham.

Present

Ewan Dale
Mark Douglas
Neil Riley by telephone link
Charles Shepherd
Barbara Stafford

Tony Britton
Gill Briody

Agenda

The minutes of the previous AGM were agreed.

Neil Riley presented the Chairman’s report

Ewan Dale presented the Treasurer’s report

Auditors for the financial year ending in December 2010 were appointed

Trustee Elections

Ewan Dale: 389 votes in favour, 12 votes against
Charles Shepherd: 410 votes in favour, 2 votes against

11 abstentions
5 votes not accepted due to membership not being renewed
11 votes not accepted as received after the closing date

Both candidates were elected

A full report on the AGM will appear in the October issue of ME Essential

POST AGM BOARD MEETING

Neil Riley re-elected as Chair
Ba Stafford re-elected as Vice Chair
Ewan Dale re-elected as Treasurer
Gill Briody re-elected as Company Secretary

Summaries prepared by Dr Charles Shepherd, Trustee

SMILE – Specialist Medical Intervention and Lightning Evaluation documents

SMILE – Specialist Medical Intervention and Lightning Evaluation documents (Lightning Process pilot study – children [now aged 12 to 18] with CFS and ME)

Shortlink: http://wp.me/p5foE-37x

See also previous ME agenda post:

“Unethical” Lightning Process pilot study in children receives ethics approval

Update: Key documents

3] SMILE Research Protocol

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/smprotv6final.pdf

Open here: smprotv6final

29] Research Ethics  Application Form

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/correspondencewithethics/recfrmrfs.pdf

Open here: recfrmrfs

University of Bristol website

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smile.html  

Source: Protocol document

 

SMILE – Specialist Medical Intervention and Lightning Evaluation

What is SMILE?

SMILE is a feasibility study to see whether it is possible to recruit young people into a study to compare specialist medical treatment with specialist medical treatment plus the Lightning Process for young people with chronic fatigue syndrome or ME (CFS/ME).

The study will also look at how we should measure outcomes and the health economic impact on the families of young people with CFS/ME.

Young people will be observed completing the questionnaires that we use to look at how unwell they are before they see us and what happens to them after an intervention. We will also talk to young people and their parents to understand what they think about the questionnaires and to determine the most acceptable and sensitive ones to use. This study is the first to work out which questionnaires we should be using to understand outcome in paediatric CFS/ME.

Frequently Asked Questions

Why is research in children needed?

Over 250 children a year already attend Lightning Process training. It is important that people know whether it is safe and effective or not. We need high quality research to answer these questions. If SMILE can recruit enough people to participate in the study then further research could look at whether it is helpful or not.

Should research be done in children before adults?

Children have the right to research particularly in illnesses which are different to adults. CFS/ME in children has a different outcome to adults and the treatment is different therefore research in adults cannot be extrapolated to children.

How will the safety of those involved in SMILE be monitored?

The safety and wellbeing of people involved in any research project, not just the SMILE project, is of the utmost importance. There is an Independent Advisory Group to oversee, and monitor this research. All participants will be carefully monitored and regularly reviewed in the specialist CFS/ME service. Young people taking part can opt out of the trial at any point.

How can we take part in the study?

Young people are eligible if they are between 12 and 18 years of age, have CFS/ME and are from the region covered by the Bath/Bristol specialist CFS/ME service. Young people are recruited at assessment so you will not be eligible if you have already been seen by the service.

What ethical review has SMILE received?

The study has been scrutinised by the South West 2 Research Ethics Committee whose role it is to ensure that research is safe and ethically sound. The ethics committee have looked in detail at the study design, and all associated documentation and suggested improvements to the readability and accessibility of the patient information leaflets and consent forms which have been adopted.

The SMILE study is compliant with Good Clinical Practice Guidelines, Research Governance Framework, Medical Research Council guidelines, Royal College of Paediatrics and Child Health guidelines for the conduct of trials and has been approved by an ethics committee.

Further information about this research project can be found in the following documents:

Smile Study Documents

[Ed: I have numbered these documents for ease of reference – they are not numbered on the University of  Bristol website.]

Note: some of the documents on this page are in PDF format. In order to view a PDF you will need Adobe Acrobat Reader

1] SMILE Information sheet for teenagers August 2010 [pdf (150kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/infoshtteensv4aug10.pdf

Open here: infoshtteensv4aug10

2] SMILE Information sheet for parents September 2010 [pdf (147kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/infoshtprntsv7sept10.pdf

Open here: infoshtprntsv7sept10

3] SMILE Protocol Final July 2010 [pdf (170kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/smprotv6final.pdf

Open here: smprotv6final

4] SMILE Under 16 assent to contact July 2010 [pdf (109kb)

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/u16asscv4july10.pdf

Open here: u16asscv4july10

5] SMILE 16 to 18 consent to contact July 2010 [pdf (110kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/16to18confinaljuly10.pdf

Open here: 16to18confinaljuly10

6] SMILE Parental consent to contact 10 May 2010 [pdf (111kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/parconsv310may10.pdf

Open here: parconsv310may10

7] SMILE Under 16 assent to study July 2010 [pdf (112kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/u16assv4july10.pdf

Open here: u16asscv4july10

8] SMILE 16 to 18 consent to study July 2010 [pdf (110kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/16to18constjuly10final.pdf

Open here:  16to18constjuly10final

9] SMILE Parental consent to study 10 May 2010 [pdf (113kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/parconssv310may10.pdf

Open here: parconssv310may10

10] SMILE teenager consent/assent to teenager interview August 2010 [pdf (110kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/tcontinvv5aug10.pdf

Open here: tcontinvv5aug10

11] SMILE Parental consent to child interview 10 May 2010 [pdf (111kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/parconcinv10may10.pdf

Open here: parconcinv10may10

12] SMILE Parental consent to parental interview 10 May 2010 [pdf (109kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/parconinvv310may10.pdf

Open here: parconinvv310may10

13] SMILE Consent to record intervention for participants, parents and those delivering interventions July 2010 [pdf (110kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/conrecintjuly10final.pdf

Open here: conrecintjuly10final

14] SMILE Lightning process assessment form July 2010 [pdf (159kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/lipcassfrmv2july10.pdf

Open here: lipcassfrmv2july10

15] SMILE letter to GP 10 May 2010 [pdf (49kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/letgpv110may10.pdf

Open here: letgpv110may10

16] SMILE WPAI [pdf (135kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/wpai.pdf

Open here: wpai

17] SMILE Health resource use questionnaire 10 May 2010 [pdf (232kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/healthresuseq.pdf

Open here: healthresuseq

18] SMILE SF-36 [pdf (165kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/smilesf36.pdf

Open here: smilesf36

19] SMILE Interview topic guide 10 May 10 [pdf (178kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/topgdev210may10.pdf

 Open here: topgdev210may10

Correspondence with Ethics Documents

20] Initial covering letter to NREC 20th May 2010 [pdf (75kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/correspondencewithethics/covlet20may10.pdf

Open here: covlet20may10

21] NREC Letter 14th June 2010 [pdf (108kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/correspondencewithethics/let14jun.pdf

Open here: let14jun

22] NREC Letter 19th July 2010 [pdf (272kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/correspondencewithethics/let19july.pdf

Open here: let19july

23] Covering letter in reply to NREC 28th July 2010 [pdf (159kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/correspondencewithethics/letrep28july.pdf

Open here: letrep28july

24] NREC Letter 13th August 2010 [pdf (72kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/correspondencewithethics/let13aug.pdf

Open here: let13aug

25] Letter re meeting notes in reply to NREC 19th August 2010 [pdf (45kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/correspondencewithethics/letmetn19aug.pdf

Open here: letmetn19aug

26] Second covering letter reply to NREC 20th August 2010 [pdf (109kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/correspondencewithethics/seclet20aug10.pdf

Open here: seclet20aug10

27] Letter in reply to NREC 13th September 2010 [pdf ( 80kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/correspondencewithethics/let13sep.pdf

Open here: let13sep

28] NREC Approval letter 14th September 2010 [pdf (213kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/correspondencewithethics/applet14sep10.pdf

Open here: applet14sep10

29] REC Form [pdf (353kb)]

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/correspondencewithethics/recfrmrfs.pdf

Open here: recfrmrfs

MEA statements: Review of NICE guideline CG53 and PACE Trial results

MEA statements: Review of NICE guideline CG53 and PACE Trial results [and BACME (British Association of CFS/ME) 2010 Conference Programme]

Shortlink: http://wp.me/p5foE-35V

The British Association of CFS/ME (BACME) appears to have taken over some of the functions of the CFS/ME Clinical and Research Network and Collaborative (CCRNC). There is no website for BACME and very little information available about the role and operation of this organisation.

BACME is chaired by consultant paediatrician, Dr Esther Crawley (lead researcher, Lightning Process pilot study in children). Assistant Chair is Alison Wearden PhD, CPsychol (lead researcher, FINE Trial).

Related information from the News section of the ME Association website (which includes extracts from BACME’s Constitution for which I do not have access to a full copy):

Questions raised over training role of new body for ME/CFS professionals

‘Parliamentarians should examine role of new NHS training forum for ME/CFS’

1] ME Association statement: NICE Guideline on ME/CFS – 2010 review process (UK)

2] ME Association statement: PACE Trial results in October (UK)

ME Association statement: NICE Guideline on ME/CFS – 2010 review process (UK)

1 September 2010

Having been led to believe that the proposed review of the 2007 NICE guideline on ME/CFS would be starting in August 2010 The ME Association wrote to NICE to seek clarification in the absence of any official announcement being made during August.

We received the following reply on 24 August:

Thank you for contacting the National Institute for Health and Clinical Excellence (NICE).

The review date which you refer to is the date at which we plan to begin the review process. We are currently beginning to gather evidence and opinions to inform our review proposal. If there has been a large amount of new evidence produced since the original guidance was produced, the review proposal may be to conduct a full review, which can take over a year. On the other hand, if there has not been very much new evidence produced, we may propose to delay the review.

The review proposal will be posted on our website for consultation in the months following the ‘review date’ listed in the guidance. To be notified of additions to web pages relating to your area of interest, including review proposals, you may like to sign up for our web alert system. You can do this via the following page of our website:

http://www.nice.org.uk/registration/index.jsp?action=registration

I am sorry that I do not have any more definitive information at this stage.

Regards

Carla Springl

Communications Administrator (Enquiry Handling)
National Institute for Health and Clinical Excellence

Level 1A | City Tower | Piccadilly Plaza | Manchester M1 4BD | United Kingdom

Web: http://nice.org.uk

We also know that members of the original guideline development group have been asked for their opinion as to whether there is sufficient new evidence to justify a review at this time.

The important phrase here is large amount of new evidence produced since the original guidance was produced.

In NICE-speak this means results from randomised controlled trials into any aspect of management that have been published in reputable peer-reviewed medical journals since August 2007. The NICE guideline is primarily concerned with the clinical assessment and management of ME/CFS and does not get involved in coming to conclusions about causation – although NICE obviously has to take note of developments relating to causation, including the findings relating to XMRV and MLVs.

Having managed to fight off a Judicial Review of the ME/CFS guideline, NICE will be feeling confident that its guidance is sound and acceptable to both patients and doctors – a position which many patient support organisations, including the MEA, obviously strongly disagree with. And with very little in the way of new evidence being published in relation to the treatment of ME/CFS, and the fact that results from the PACE trial are fast approaching, it seems likely that NICE may decide to defer this review until later in the year, or even 2011, when they have this information – which could well strengthen their controversial recommendations regarding cognitive behaviour therapy (CBT) and graded exercise therapy (GET).

It should also be noted that NICE will not want to re-open the debate about existing evidence (ie results from clinical trials that were published up to the time of the 2007 guideline) – they want to look at new evidence.

The ME Association will obviously be challenging the current recommendations regarding the use of CBT and GET and to support out case we will be making use of the patient evidence (approx 4,500 respondents) from our 2010 Management Report – the largest ever survey of patient opinion ever carried out in the UK, probably in the world. This report can be accessed on-line here:

http://www.meassociation.org.uk/index.php?option=com_content&view=article&id=1283&Itemid=223

We are also consulting with various experts, including those with statistical knowledge, about how best to present our case to the review.

For information purposes the following explanation of how recommendations contained in a NICE guideline should be interpreted by clinicians when making decisions about patient management is worth noting. It clearly contradicts the mistaken view of some doctors that NICE guidelines are almost mandatory and as a result they are no longer able to exercise their clinical judgement where this is may not be entirely consistent with a guideline position.

NICE clinical guidelines are recommendations about the treatment and care of people with specific diseases and conditions in the NHS in England and Wales. Clinical guidelines represent the view of NICE, and are arrived at after careful consideration of the evidence available. Healthcare professionals are expected to take it fully into account when exercising their clinical judgement. However, the guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer, and informed by the summary of product characteristics of any drugs they are considering.

Implementation of this guidance is the responsibility of local commissioners and/or providers. Commissioners and providers are reminded that it is their responsibility to implement the guidance, in their local context, in light of their duties to avoid unlawful discrimination and to have regard to promoting equality of opportunity. Nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties.

With regards to technology appraisal guidance, this type of guidance contains recommendations on the use of new and existing medicines and treatments within the NHS. The NHS is legally obliged to fund and resource medicines and treatments recommended by NICE’s technology appraisals, usually within 3 months of guidance being published.

ME Association
1 September 2010

http://www.meassociation.org.uk

ENDS

Ed: This BACME conference and AGM is being held in Milton Keynes on 13 and 14 October and is faciliated by AYME who have collaborated in CCRNC conferences.

Download PDFs for BACME Provisional Programme and Registration Form here:

BACME 2010 Conference Programme

BACME CFS ME CCRNC conference 2010 Registration Form

 

2] ME Association statement: PACE Trial results in October (UK)

3 September 2010

It is being reported today in Link magazine (issue 39, September 2010) that:

Data collected for the one year follow up of the PACE trial is currently being analysed in preparation for publication of the findings.

Professor Peter White of St Bartholomew’s Hospital, London will report on the most up-to-date progress and baseline data from the PACE trial to delegates at the British Association of CFS/ME (BACME) October conference.

The release of this PACE trial information may well have an effect on a decision by NICE as to when they commence a review of the 2007 Guideline on ME/CFS.

A statement and more information on the NICE Guideline review can be found in the September news section on the MEA website.

Information supplied by ME Association: http://www.meassociation.org.uk

ENDS

BACME CFS ME CCRNC conference 2010 Registration Form

BACME 2010 Conference Programme

Provisional Programme

British Association of CFS/ME (BACME)
2010 Conference

Draft Program – please note there may be changes before final program

Milton Keynes 13-14 October
Wednesday 13 October

9.30 -10.30  Registration and coffee

10.30-11.00  Opening Address:

Prof Stephen Holgate  MRC (Medical Research Council)  Clinical Professor of Immunopharmacology. 

“The time has at last arrived to strengthen research into CFS and ME”

11.00 – 12.00  Keynote Speaker: Professor Daniel J. Clauw MD Division of Rheumatology University Michigan

“Advances in Our Understanding of CFS and Overlapping Conditions”

12.00 – 1.30  Lunch Hot and Cold Buffett (preference to be booked)

1.30 -2.15  Dr Alison Wearden Reader in Psychology: FINE Trial

“Pragmatic rehabilitation for Chronic Fatigue Syndrome/ME”

2.15 – 3.00  Judith Harding:
The Role of Diet Management in CFS/ME

3.00 – 3.30  Comfort Break

3.30 – 5.00  Uni – professional Networking Groups.
To be facilitated please contact maryjane@ayme.org.uk asp if you would like to request a specific group e.g physiotherapists, nurses, paediatricians

5.00 – 6.00  BACME AGM Chairperson: Gill Walsh
(for existing and new members)

7.30  Conference Dinner (to be pre-booked separately)

Thursday 14 October

9.00 Registration & Coffee

9.30 – 10.45  Workshop 1

10.45 – 11.15  Coffee & Comfort Break

11.15 – 12.30  Workshop 2

12.30 – 1.45
Lunch Hot and Cold Buffett (preference to be booked)

1.45 – 2.15  Poster Presentations – Organiser Gabrielle Murphy
Posters will be on display for the whole 2 days

2.15 – 2.45  Coffee & Comfort Break

2.45 – 3.30  Diane Cox & Heather Garry
Video Conferencing for delivery of CFS/ME Interventions at Home (Tele-rehabilitation)

3.30 – 4.30  Professor Peter White
St Bartholomew’s Hospital London

“PACE trial: so near yet so far”

(If outcome results are not yet published, Peter White will present the design, progress and baseline data from the trial)

4.30 – 5pm  Closing Address – To be announced

WORKSHOPS

1. Working with the Severely Affected – Leeds Service

2. Mindfullness and ME –The Mindfull Approach to Chronic Illnesses Steve Johnson, Director of the Breathworks Foundation

3. Review of Literature and Clinical Implications on Sleep (please note this is not a workshop) Gabrielle Murphy & Alex Westcombe

4. To Be Announced

5. Research workshop – How to do research successfully when you are a busy clinician – Professor Peter White

6. Group work – Michelle Selby and Helen Chub

 

Additional information on selected presenters:

Breathworks
http://breathworks-mindfulness.org.uk/the-breathworks-foundation.html

Gabrielle Murphy
Physician working in the Fatigue Service at the Royal Free Hospital and Clinical Lead. She also works in the Department of HIV medicine. Her interests include medically unexplained symptoms MUS). Also involved in local and national organisations promoting access to CFS/ME services and ongoing research.

Coping Better With Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Cognitive Behaviour Therapy for CFS/ME
http://www.karnacbooks.com/Author.asp?AID=13770

Alex Westcombe
North Bristol NHS Clinical Psychologist
http://www.nbt.nhs.uk/services/criticalcare/painmanagement/who_is_who.htm

Michelle Selby
OT lead Dorset CFS Service (formerly “The Wareham Clinic”); Clinical Co-ordinator, Southampton CFS/ME Clinic
http://www.meactionuk.org.uk/RiME_CFSME_Centres_Condemned.html

Dr Helen Chubb
Senior Registrar, Whitchurch Hospital
Chronic Fatigue Syndrome – personality and attributional style of patients in comparison to healthy controls and depressed individuals: Helen. L. Chubb; Irene Jones; Janice Hillier; Christopher Moyle; Stephanie Sadler; Tanya Cole; Kate Redman; Anne Farmer
DOI: 10.1080/09638239917274 Journal of Mental Health, Volume 8, Issue 4 August 1999 , pages 351 – 359
http://www.informaworld.com/index/T32L42TTQ9N74DN3.pdf

Accessing a copy of MRC National Archives material via PDF

Accessing a copy of MRC National Archives material via PDF

Shortlink: http://wp.me/p5foE-34g

NB: If the link isn’t working for you, try this:

Go to this URL:

http://www.nationalarchives.gov.uk/documentsonline/default.asp

which is the National Archives Documents Online page

Put this Catalogue reference code into the Search box

FD 23/4553

Select date range 1950-99

that should bring up the page. Then pick up my instructions from there.

Instructions:

Go here:

http://tinyurl.com/NationalArchivesMRC

that is:

http://www.nationalarchives.gov.uk/documentsonline/details-result.asp?queryType=1&resultcount=1&Edoc_Id=8553429

The National Archives Documents Online

Description Myalgic encephalomyelitis (ME)/postviral fatigue syndrome (PFS) : papers and journal articles; correspondence and enquiries with MRC replies

Date 1988-1997
Catalogue reference FD 23/4553
Dept Records created or inherited by the Medical Research Council
Division General Records of the Medical Research Committee and Medical Research Council
Series Medical Research Council: Registered Files, Scientific Matters (S Series)
Image contains complete documents usually loaded

———————

Click “Add to shopping” (there will be no charge, so don’t worry)

Click “Check out”

An email address will be requested.

Fill in a working email address.

Click “Proceed with your download”

An auto generated email will be sent to you.

The email you receive will include an order number and the date up until which the file will be available to you. (This was 28 days.)

Beneath the words:

“Your images are now available. If you have not already downloaded them, please go to the download screen at”

There is a clickable link “Download my documents now”.

Click the link which will take you to a PDF URL. The URL will be specific to your email address.

The URL will open a PDF of approximately 30 MB which you can save to your hard drive in the usual way.

The file consists of a 143 page bundle of copies of letters, responses, papers, notes of meeting and handwritten notes.

Some pages, extracts, names and addresses have been redacted and are marked:

“REDACTED UNDER
FOI EXEMPTION
SECTION 40 (2)
CLOSED UNTIL 2071”

———

(Note: This is a very large file which is why National Archives do not supply it via an email attachment. I accept no responsibility for the consequences of anyone being inconsiderate enough to forward the file as an email attachment which may cause considerable problems for some email account holders.)

Related material

28 December 2009

Response from Public Services Development Unit, National Archives

http://wp.me/p5foE-2yP 

11 December 2009

The Medical Research Council’s secret files on ME/CFS: Margaret Williams

http://wp.me/p5foE-2vm

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

Action for M.E. issues second position statement on Lightning Process pilot in children 8 to 18

Action for M.E. issues second position statement on Lightning Process pilot in children 8 to 18

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

Action for M.E. Second position statement

20 August 2010

Issued via Action for M.E. Facebook Wall

Action for M.E. is very concerned that the Lightning Process is being given to children in the UK without having been formally evaluated for effectiveness and safety.

Although the MRC ethics guide says that research involving children should only be carried out if it cannot feasibly be carried out on adults, there are exceptions eg. studies which aim to increase understanding of child health or shed light on a disease, its natural history and possibilities of prevention.

Before any research is approved, an ethics committee scrutinises the proposals to ensure that the rules about research involving children are satisfied. The committee also ensures that proper safety systems are in place and include safety monitoring by an independent committee.

As long as the ethics committee gives its approval, the charity supports proposals to investigate whether it is possible to set up a controlled trial to look at the Lightning Process and how it compares with current treatments for M.E./CFS in children.

Dr Esther Crawley is a Consultant Paediatrician specialising in CFS/M.E. and a leading researcher in the field. Together with Dr Margaret May and Dr Alan Emond, Dr Crawley has recently published new research on phenotypes of CFS/M.E. in children in the journal Archives of Disease in Childhood.

They showed that there appear to be three different phenotypes: musculoskeletal (the main symptoms being muscle and joint pain), migraine and sore throat. None of the phenotypes were associated with age or length of illness suggesting that they did not merely reflect deconditioning. The lack of association with symptoms of depression or anxiety (with the exception of the migraine phenotype) also suggests that they are unlikely to reflect mood disorders.

At the end of March, Action for M.E.* had published this position statement on its Facebook Wall but not on its main website:

Action for M.E. sees no reason to oppose this pilot study.

As was made clear when it was announced, the research at this stage is simply a pilot designed to see if it would be possible to set up a trial that can independently assess the Lightning process against specialised medical care.

It is a fact that many parents are already taking their children to LP practitioners and so there are urgent questions that need to be addressed in order to assure the safety of those children. Dr Crawley’s initiative aspires to find a way of answering some of those questions.

*Sir Peter Spencer, CEO of Bristol based, Action for M.E., is a non-executive director of the Royal National Hospital for Rheumatic Diseases, NHS Foundation Trust – Dr Esther Crawley’s employer.

25% ME Group position statement on Lightning Process pilot study in children 8 to 18

25% ME Group position statement on Lightning Process pilot study in children 8 to 18

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

Today, the 25% ME Group has issued a position statement on the Dr Esther Crawley led RNHRD NHS FT Bath / University of Bristol proposed pilot study into the feasibility of recruiting to a randomised controlled trial (RCT)comparing the Lightning Process with specialist medical care.

The Medical Advisors to the 25% ME Group are Dr Byron Hyde (Canada) and former UK NHS paediatrician, Dr Nigel Speight.

Whilst I welcome the issuing of this statement, it should be noted that the press release announcing the pilot study was issued over five and a half months ago.

According to information provided by University of Bristol Information Rights Officer and their Director of Legal Sevices, information on the study and the research protocol is anticipated to be published on the University of Bristol website by the end of this month. 

This suggests that ethics approval for the pilot study may now have been obtained.

It is not known whether the 25% ME Group has or intends to make representations to any individual, institutions, organisations or bodies.

The document is heavily formatted and I will be posting a copy of the text, later.  In the meantime a Word version of the group’s statement can be opened here:

25% ME Group LP Research Position Statement 20.08.10

Dr Esther Crawley discusses XMRV and WPI, March 2010

Dr Esther Crawley discusses XMRV and Whittemore Peterson Institute (WPI), March 2010

Part transcript: Presentation to the Dorset CFS/ME Society Annual Medical Lecture: section on XMRV.

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

XMRV: Whittemore Peterson Institute (WPI)  Opens on campus of University of Nevada (Parts 1 and 2)

Sam Shad for Nevada Newsmakers

Part 1

Part 2

 

Update: This transcript was revised on 20 August and supersedes previous versions.

May be reposted if posted in full, unedited and a link to source is given.

Dorset CFS/ME Society
Annual Medical Lecture

27th March 2010

The Future of Research in CFS/ME

Esther Crawley

Intro:

It’s a great pleasure to be here, everybody, and I’m really glad actually that my talk actually fits in very nicely with what William’s just said – Phew!

I’m going to be talking a lot about the collaborative research and the first half of my talk actually was given to the MRC Working Group at the end of last year. So you’ll actually see what we were talking about where the MRC gathered lots and lots of researchers together to discuss a way forward with chronic fatigue [sic] and I did the talk on Epidemiology.

[…]

[Slide]

I couldn’t resist talking about XMRV. I think we have to know about what’s actually happened and I will discuss that as well and what the implications are.

[…]

[Rest of intro and presentation skipped.]

Approx 27 mins in from start of presentation:

[Slide]

XMRV. OK, so in the next, last, remaining bit of the talk I want to summarise what’s happened about the XMRV story for you. I think it’s really important that we’re all informed about it.

Many of you will have woken up and read this story, in fact I knew about it 24 hours before it was about to break – “Has science found the cause of chronic fatigue syndrome?” – we’re all very excited and hopeful this might give us something we can treat. Great.

[Slide]

Don’t you think this is the most beautiful picture? That’s the XMRV virus. I don’t know how they get those colours on them – very beautiful.

Now this is the Centre that reported it. Do any of you notice anything about that picture? XXXX you’re not allowed to say.

Sorry?

Member of the audience: Sunshiny?

EC: Sunshiny, yeah. It’s in Reno, yeah, yeah. Anything else? It’s a bit far away.

Has anyone looked at the website? Isn’t that interesting? That doesn’t exist. That’s a fake picture – it’s what they would like to exist, when you donate money, when you go on the website. I thought everybody knew that! Yeah, sorry? This is Dorset.

OK. The Centre isn’t built. That’s their picture of what they would like to build and when you go on the website it has “Please donate.”

OK. What do the Lombardi group originally show?

[Slide]

OK. This is a complicated slide. I’m just going to take you through bit by bit because it’s really important when we look at all the research evidence.

OK. The gag sequences – the DNA that’s associated with these particular type of viruses – so they use PCR. PCR is basically when you get a tiny bit of DNA and you multiply and multiply and multiply and then you run it on a gel and see if it’s there. And what they found, and you’ll all remember these figures, I’m sure, is that they found it in 68 out of 100 [Ed: 101 on slide] chronic fatigue [sic] patients and 8 out of 218 controls.

They then looked in the cells and they found the protein in the cells and then they looked at whether it’s infectious. Now I have to say, this bit made me slightly worried – so they looked to see whether this virus could infect other cells within the lab and they showed that it’s infectious and they also looked at what happened if you put the virus with other cells in terms of did it develop an immune response?

[Slide]

And these are some of the pictures they showed. So when you multiply out the DNA, you then run it on a gel and you tag it with a thing that shines – I did my PhD doing this, I can tell you all sorts of awful stories of gels breaking and all sorts of other things going wrong. But these are the chronic fatigue [sic] patients – you see all these lines, here? That’s that gag sequence – here and here – that’s the end of the line and these are the controls.

Then they looked at the expression in cells and you could see it. And then they looked at the infection and this is the infection happening here.

Now this paper went out for review by virologists – not by clinicians and that’s a very important point and it was passed and it was published.

[Slide]

And this is what they said on their website and I think this is kind of interesting: “

“We have detected the retroviral infection XMRV is greater than 95%…”

Where did the 95% come from? Did anybody notice the 95%? Can anybody remember the percentage they found it in? Yeah, 66% [sic], slightly less.

OK. Says on the website “…95%…The current [working] hypothesis is that [XMRV]…” infects these cells…and I found this absolutely terrifying…viral chronic fatigue syndrome “causes the chronic inflammation and immune deficiency resulting in an inability to mount an effective immune response to opportunistic infections”.

OK. Have they shown any of that? Have they shown increased risk of opportunist infections? Have they shown a defect in the immune system that’s actually going to affect someone rather than just in a cell lab plate?

[Slide]

No. But that’s what’s on their website. That’s what they say they’ve found. So what happens? The research community runs to replicate the work.

[Slide]

OK. And you’ll all remember when this first paper came out “Failure to replicate…” – this is an English paper [Ed: the McClure PLoS ONE paper]. Well obviously this is wrong because they didn’t use the same techniques and it wasn’t the same patient group.

[Slide]

So in this particular experiment, they actually characterised the patients.

Now on the original paper, they say that the chronic fatigue [sic] patients were well-characterised but they do not describe them at all. We don’t know how many were girls – we don’t know how many…girls! – I’m such a paediatrician – we don’t know how many were female. We don’t know how long they had had the illness for. We don’t know who diagnosed them and we don’t know whether they had any blood tests to exclude other illnesses.

In this one, [Ed: the McClure paper], they actually had all the exclusion stuff excluded, they then used the DNA sequence. They had positive and negative controls. Why do you need positive and negative controls? Yes, so you’re worried that maybe when you do PCR it’ll pick up…you’ve all seen crime scenes, right? So PCR will pick up one bit of DNA, so if you’ve got a bit of DNA in your solution or something like that, you must have negative controls because you need to be certain that the DNA has come from the samples – not from your lab solutions.

Yes. OK. And you must have positive controls to make sure your experiments work.

They used a virus free laboratory. So they did it in a laboratory that had not had the virus in the past and they blinded the person doing the PCR. Does everyone know about “blinding”? So what they did, was that the person that was reading the gels didn’t know whether they were patients or not, because it’s really easy on those gels to over-interpret what you see.

OK and their results, you might all remember, they didn’t find any out of 186 patients – none of them had chronic fatigue [Ed: corrects herself] – XMRV.

[Slide]

And then a few days later, this one came out. This one had several people from England – Jonathan Kerr and so on. And they’re very open – they said, John Gow – these are all people that we’re collaborating with – they said we wanted to find chronic fatigue syndrome – we wanted to find the XMRV virus. We wanted to – we looked hard.

Now the criticism of the previous paper was that they hadn’t used the same techniques, so in this one they used the same techniques. They had 170 patients, 395 controls. You can already see the sample size is much bigger and they did both PCR and looked at the serology.

They found none in 299 samples of patients – had chronic fatigue [Ed: corrects herself] – had XMRV. And although they found what’s called “neutralising activity” they looked at this further and suggested that the immune response was actually related to other viruses and not to the XMRV.

[Slide]

And then this was published a couple of weeks later [Ed: BMJ paper] – from the Dutch group. Again, a very well described Dutch cohort – smaller, 76 patients 69 controls. And what they did, they actually went completely overboard with trying to find it. They used very, very sensitive techniques that should have detected – if any was there at all, they should have detected it – much more sensitive than the original paper and they looked at a variety of DNA and they tried several times to improve the sensitivity – all samples were negative for XMRV.

So what do you think’s going on?

Member of the audience: Publicity.

EC: Publicity…

….I have actually given a clue.

Member of the audience: Money?

EC: Sorry. Money…money…money…

Member of the audience: XXXX wants to tell us.

EC: OK, go on, XXXX…

EC’s young son (in front row): Did they all do it from one place?

[Slide]

EC: Ye…es! The first group – actually, the question is, was the first group chronic fatigue syndrome? And eventually, when they were asked, they told the research community that, this is in Lisbon, at the end of last year, that all the samples came from an outbreak of chronic fatigue syndrome in one village in Lake Tahoe.

And when you actually go and have a look at all the research data around that outbreak, everybody at that time thought it was a viral infection. And nobody could find the virus.

So most of us think that that was probably the issue – it was probably a viral outbreak that has certainly caused chronic fatigue syndrome but is not necessarily going to be relevant for us here in the UK.

[Slide]

It’s not clear about the PCR operator, the person that looks – it’s not clear from the paper, whether they were blinded. There might be issues about whether you work in a virus free lab, remember they showed that this was infectious.

And there’s a big question here [Ed: indicates on slide] – this XMRV virus was initially described with prostate cancer and the prostate research community has shown this in prostate cancer in two studies in the USA. These are different labs in different studies but no association in Europe.

So maybe this is a virus that’s important in America but not important in this country – it’s not clear.

And I think this is of interest. Within a week of their paper being published they produced a test for the XMRV virus at $650 a test. [Ed: Slide reads, at point 4: Conflict of interest?].

And if I was developing a test, I would declare that as a conflict of interest on the paper – “I’m developing a test for this.” Then people can make up their mind about whether it has affected the results. We don’t know, it wasn’t declared they’d produced a test.

[Slide]

Why are patients so upset?

OK, well I don’t know and you’ll probably be able to tell me more than I can tell. But I think when they first publicised this they went on everything, lots and lots of American television.

[Slide]

[Reads from slide]

“Vindication” they said, “This “[new] report has intrigued scientists, been seen as vindication by some parents [Ed: corrects herself] – patients and inspired hope for treatment.”

Well you know, the history of this condition is that patients have not been listened to, they’ve been dismissed, they’ve had a terrible time and if a virus comes along as a cause, that is going to be seen as a vindication – I can understand that.

And it’s very disappointing, isn’t it, the negative replications?

[Slide]

But I do think that there’s been other stuff that’s been going on that I have particular difficulties with. When I prepared this talk for an infectious diseases conference, I went through and I just got some quotes off the web from the research team.

[Slide]

Look at this:

[Reads from slide]

“Here you’ve got your immune system working well and the virus and the immune system are coexisting just fine and then some other bug, whether it be Lyme, a flu, anything gets you…and then you’ve just tipped the scale to where your immune system can’t handle [XMRV] or anything, and every day you’re seeing new infections.”

[Slide]

And then at one point, rumour has it (and I couldn’t find any evidence for this) that they started to suggest that patients with chronic fatigue syndrome should have anti-retrovirals, ie HIV drugs.

They’ve taken that back, and this is all I could find:

[Slide]

[Reads from slide quoting Dr Judy Mikovits; the “she says” refers to Dr Mikovits]:

“While it’s not advisable to take highly toxic anti-retrovirals [without tests confirming effectiveness], she says some available therapies may help, including: immune modulators; anti-inflammatories, because inflammation activates XMRV, things that improve natural killer cell function; medications that help [level progesterone levels, because progesterone up-regulates XMRV in lab tests]; avoiding stress.”

It appears – and this really upset me, OK. All of their studies are in adults. OK, all in adults. And then they say:

[Reads from slide]

“Early infection in children can lead to more severe disease later on.”

Early detection?

Oh, that’ll be that test that they produced for $605 [sic] a pop.

[Reads from slide]

“and intervention important to keep viral loads from getting high.”

I find that really frightening. If I had a child with chronic fatigue syndrome and I read that on the web, the first thing I’d do, I’d go and buy the test, and the second thing I’d be doing would be phoning an infectious disease doctor which is what’s happened and ask about anti-retrovirals for my child, having read that.

So I do feel as researchers, we do take some responsibility for saying “This is a first paper! Let’s wait and see what happens.”

You know, I think it’s really interesting, it look likes they did find something in a group of patients and we haven’t found it here. That’s really interesting and is deserving of more research. But let’s just say, it’s interesting at the moment, rather than all of this speculation, which I think can be very harmful for patients.

[Slide]

The future for infection

OK, I gather that this may well already have happened, not been published, the way forward in these things is to replicate the studies in both labs and try and look at why there are differences.

I think it may be important for a subtype of chronic fatigue syndrome.

I very much doubt it effects all of them, as they claim.

It doesn’t appear to be important in this country.

And there’s actually very beautiful research which we need to understand more, looking at the relationship between genetics, infection and other things like mood.

OK. After a whistle-stop tour of most research on chronic fatigue syndrome, this is now my summary slide – this is what I’ve talked about.

[Slide]

There are two arms for research in chronic fatigue syndrome and I don’t believe that one replaces the other. The funding for both arms is different in this country and they both need to be done together and both influence the other.

[Slide]

The first is important for providing services and treatment:

We need to know more about how common this is.

We need to understand who it affects.

And we need to know about the different types of chronic fatigue syndrome.

We need to understand how the different types influence treatment.

We need to know much, much more about the impact of this devastating condition on patients and carers.

The second one is that we need to know more about the aetiology, about the causes of this condition and in my view, the fastest way forward is to use the large, very large sample sizes that we have available in this country to conduct rigorous genome-wide association studies and I’m not so certain about the role of infection but I do think there is an interesting story with XMRV that we need to get to the bottom of.

And it just remains for me to thank my funders – I’m funded by the National Institute of Health Research and my Clinician Scientists Fellowship, the Linbury Trust, Action for M.E. and I’m the Medical Adviser for AYME.

[Slide]

And this is where I work.

Thank you very much.

——-

There was a Q and A session which included questions about the RNHRD NHS FT/University of Bristol Lightning Process pilot.

Teen ‘trained’ to overcome illness: This is Cornwall

Teen ‘trained’ to overcome illness: This is Cornwall

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

“It has taken Rebecca huge determination and commitment to get to this stage,” said Mrs MacDonald, who hopes new research being led by Dr Esther Crawley, consultant paediatrician at the Royal National Hospital for Rheumatic Diseases NHS Foundation Trust, will go some way to getting the training accepted by the NHS.*

“It really can benefit lots of people who feel there is no hope – we’re proof that you can overcome ME and CFS. Hopefully research will provide us with a better understanding of how it works and enable the NHS to support it,” said Mrs MacDonald.

*For background to this controversial pilot study see ME agenda 5 July report:

Advertising Standards Authority (ASA) Adjudication: Withinspiration (Lightning Process)

This is Cornwall  |  6 May 2010

Teen ‘trained’ to overcome illness

A FORMER Truro teacher who made a “miraculous recovery” from being wheelchair-bound by ME has helped transform the life of a Redruth schoolgirl by ‘training’ her to overcome the same condition.

English teacher Julia MacDonald, who spent nine years in a wheelchair being spoon fed puréed food by her husband, made a remarkable recovery after taking part in a training programme that draws on the techniques of life coaching and osteopathy.

So inspired by the Lightning Process training, Mrs Macdonald now runs her own three-day courses.

Life-changing

“I became reliant on my husband for everything, then the training changed my life,” said Mrs MacDonald.

Rebecca Burns, 16, of Redruth, who recently completed the training, which is currently not recognised by the NHS, believes her own “amazing” recovery is down to the same technique.

“I was 11 when I had a bad bout of flu – I never really got over it and my symptoms got worse over time,” said Rebecca, who spent the next five years going back and forth to various clinics and hospitals hoping to find a diagnosis for her mystery illness.

“I was suffering pains in my stomach and legs, nausea, and memory loss,” said Rebecca, who was pulled out of school by the time she was 15 because her condition had become so severe.

“I was in a wheelchair and virtually housebound because I was so nervous of meeting people and going outside.

“My parents were very anxious as no one was able to identify what was wrong, then they diagnosed ME and chronic fatigue syndrome (CFS). It was a relief at first, until they said there was nothing they could do to help me.”

Desperate to find a cure or treatment for their daughter, Rebecca’s parents signed her up for the training, although sceptical of its benefits at first.

“I’m not sure they were totally convinced it would work and they didn’t want to build my hopes up,” said Rebecca who went on to make a full recovery.

“On the first day I remember feeling excited and saying to myself this will work.

“I went home and walked the dog for the first time in a year. And then on the second day I woke up and saw colour in my face. Instead of being gaunt and tired, I knew then that I had turned a corner.”

“It has taken Rebecca huge determination and commitment to get to this stage,” said Mrs MacDonald, who hopes new research being led by Dr Esther Crawley, consultant paediatrician at the Royal National Hospital for Rheumatic Diseases NHS Foundation Trust, will go some way to getting the training accepted by the NHS.

“It really can benefit lots of people who feel there is no hope – we’re proof that you can overcome ME and CFS. Hopefully research will provide us with a better understanding of how it works and enable the NHS to support it,” said Mrs MacDonald.

Rebecca now hopes to complete her education by embarking on a course at Truro College, something that she never thought would be possible.

For further information please go to www.lightningprocess.com or www.juliamacdonald.co.uk tel 01872 870001.

 

This is Bath  |  25 March 2010

Letters from Dr John Greensmith

Will this new trialled process really aid the ME sufferer?

Dr Esther Crawley will, no doubt, receive questions about her proposed research using the Lightning Process in children diagnosed with CFS/ME (‘Money for Min children’s study, Bath Chronicle, March 4) relating to the validity and reliability of her experimental design, her subject selection, the statistical analysis, as well as any additional particular ethical considerations of working with children.

But I have some more fundamental concerns even before these are raised.

The reality is that there is no reason to believe – whether it has any ameliorative effect on any organic illness at all – that the Lightning Process will cure, or aid recovery in, people with ME and there is a possibility that it could even have a negative influence or be harmful.

Despite attempts to give the Lightning Process some scientific respectability by claiming some theoretical chemical or neurological processes and claiming support from academic researchers, there is none that can be relied upon.

There are at least three serious problems underlying any claims for its use with ME sufferers:

(1) only hearing one side of the story;

(2) distorted statistics and;

(3) the relatives of the celebrity endorsers may not have had ME at all.

We only ever hear positive testimonials because any negative ones have been selectively edited out of the Lightning Process website, where only favourable testimonials and press coverage seem to appear.

The extravagant 85 per cent success claim is distorted, primarily because most people with ME would not be able to make it to the place where the Lightning Process is given, or have the stamina to do three days together, so are not even in the reckoning.

It is difficult to check the claims of the celebrity endorsers of the Lightning Process without possibly compromising the patient confidentiality of their relatives, for whom they claim such great success.

The most severely affected people with ME (not the CFS/ME mongrel) will not have even been considered; the Lightning Process will be promoted, in addition to as endorsed by celebrities, as a mainstream treatment worthy of study by reputable academics and yet there will have been no significant return to school, work or resumption of a normal lifestyle.

It is not true to say that if the Lightning Process does no good it will not do any harm.

For people who have had ME for many years and who have tried everything on offer that hasn’t worked, this may be yet another disappointment or even the last straw.

I hope that Dr Crawley will prove my predictions wrong.

I beg her to, at the very least, postpone her proposed research until she has addressed these serious underlying issues.

DR JOHN H GREENSMITH ME Free For All. org Downend Bristol
 

 

(Ed: An edited version of the comment below is also published on the site of This is Cornwall  in response to “Teen ‘trained’ to overcome illness” 6 May 2010.)

Comments (25)

The “Lightning Process” is controversial, unregulated and untrialled.

According to information obtained under the Freedom of Information Act, this proposed RNHRD NHS Foundation Trust Bath/University of Bristol pilot study led by Dr Esther Crawley has yet to obtain research ethics approval.

The pilot study seeks to involve children as young as eight. Children are considered a vulnerable research group and the Medical Research Council (MRC) and other institutions, like the Royal College of Paediatrics and Child Health (RCPCH) and the General Medical Council (GMC), publish specific ethical guidelines for research using children and young people. MRC guidelines are clear:

“Research involving children should only be carried out if it cannot feasibly be carried out on adults…

“…Have previous laboratory studies, animal research, studies with adults, or other data provided a sufficient basis for proceeding with research involving children?”

To date, no rigorous randomised controlled trials (RCTs) have been carried out in adults and there is no reliable data on the safety of the application of the Lightning Process in adult patients with CFS and ME.

On 4 August, two of Britain¿s leading ME and CFS charities, The ME Association and the Young ME Sufferers Trust, issued a joint statement and press release condemning this proposed pilot study as unethical and calling for it to be abandoned.

The two charities say:

“We are issuing this joint statement due to widespread public concern, together with our own serious reservations, about a forthcoming study of the psychologically-based Lightning Process on children.”

“We cannot approve of a study involving children as young as eight when no rigorous trials have first been undertaken into the safety, acceptability, long and short-term effects of the application of this controversial and unregulated ‘process’ with adults.”

The full statement can be read here:

http://tinyurl.com/MEA-TYMESTrust-LP-Statement  

It is feasible to carry out research into the application of the Lightning Process using adults with CFS and ME but the research team has provided no rationale for seeking ethics approval to undertake research using a vulnerable patient group first.

With no access to robust data, the research team and the Research Ethics Committee(s) considering the application for ethics approval are not in a position to determine that overall the likely benefits of the research outweigh any risks to child participants diagnosed with CFS or ME.

Furthermore, parents, and children considered competent to give consent, are not in a position to give informed consent because there is no data from adult RCTs.

It is also a matter of public interest that the Dr Crawley’s research team has sought to obtain the advice, guidance and involvement of a Lightning Process practitioner who, in June, was subject to an Advertising Standards Authority (ASA) ruling in relation to claims being made in an advertisement about the efficacy of the Lightning Process for CFS and ME.

The Advertising Standards Authority¿s remit does not extend to website content but there is public concern that there are websites for practitioners offering the Lightning Process to adults and children where unsubstantiated claims are being made that clients have “recovered from, or experienced significant improvement” from diseases and conditions which, in addition to ME and Chronic Fatigue Syndrome, are claimed to include “…urinary infections, coeliac disease, crohns disease, blood pressure, cardiac arrhythmia, type 2 diabetes, hyper/hypo thyroidism, autistic spectrum disorder, dyspraxia, ADHD, lymes disease, glandular fever, epstein barr virus, multiple sclerosis, cerebral palsy, parkinsonian tremor and motor neurone disease.”

Suzy Chapman, Dorset, UK
commented on 09-Aug-2010 19:46

Invest in ME Decline BACME Invitation

Invest in ME Decline BACME Invitation

Shortlink: http://wp.me/p5foE-2Z2

Invest in ME has issued a statement around its decision to decline an invitation to become a member of BACME (British Association for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis).

For Invest in ME’s position statement on the proposed Bath/Bristol pilot study to investigate how to recruit to a randomised controlled trial looking at the Phil Parker Lightning Process and specialist medical care in CFS/ME in children as young as eight, go here Invest in ME March 2010 Newsletter.

 

Invest in ME Decline BACME Invitation

Invest in ME recently received an invitation from the British Association for Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis (BACME) inviting us to apply to become an executive member of that organisation.

BACME is chaired by consultant paediatrician Dr Esther Crawley – who was recently awarded a grant to do a clinical trial on the Lightning process (funded with £164,000 from the Linbury Trust and the Ashden Trust) – a business which assumes that no matter what is causing an ME patient’s illness it will help cure a patient from them.

With cases of people with ME being made worse from this business the recent Norwegian film by Paal Winsents (“Make Me Well”) illustrates the danger of people with no medical training attempting to treat a neurological illness such as ME. A telling quote from a LP practitioner in that film says it all –

“…. It does not matter how it started. Sometimes people had a bacterial infection, sometimes people had a viral infection. It does not matter how it started. The Lightning Process works equally well”.

Such uninformed, non-clinical and dangerous statements being used by people promoting businesses without any medical training, at a time when the need for more funding for biomedical research into ME and the evidence to support that funding requirement is overwhelming, is symptomatic of the problems on a non-strategic, non-biomedical approach to diagnosing and treating people with ME. Meanwhile ME patients and their families have to witness this absurd waste of money.

Dr. Crawley’s views on ME aren’t those of Invest in ME’s and we have serious concerns about her position as chair of an organisation such as this.

The Assistant Chair of BACME is Alison Wearden, who is Reader in Psychology at the University of Manchester, Chair Elect of British Psychological Society’s Division of Health Psychology and Associate Editor of British Journal of Health Psychology and whose studies include “Illness cognitions and diabetes – how the beliefs which patients hold about their diabetes impact on their attempts to manage it, their adjustment and well-being”. Wearden was head of the FINE trials (click here) – a waste of taxpayers’ money which resulted in nothing of value for people with ME.

BACME has a constitution to which members have to sign up. In this constitution, which BACME requires its members to support, it includes the following-

2.2 Objectives

2.2.1 To champion evidence-based approaches to the treatment of CFS/ME, such as those provided in the NICE guidelines

2.2.4 To support the delivery of services and to enable services to maintain standards of care in the treatment of CFS/ME as set out in the NICE guidelines

4. The Executive

4.1.4 The BACME Executive will invite no more than four people drawn from National UK CFS/ME organisations which explicitly support the aims and constitution of the organisation to sit on the Executive committee as either observers or members

Invest in ME rejected the NICE Guidelines and therefore cannot agree to endorse a constitution which lists among other things the above objectives.

Invest in ME endorse the critique set out by Twisk FNM, Maes M. in their review of CBT/GET in which they state

“So, it can be concluded that the efficacy claim for CBT/GET is false. But what is more important, is the fact that numerous studies support the thesis that exertion, and thus GET, can physically harm the majority of the ME/CFS patients.

This assertion is confirmed by the outcomes of two large patient surveys in the UK and Norway, and two smaller surveys in Scotland and the Netherlands.”

(A review on Cognitive Behavorial Therapy (CBT) and Graded Exercise Therapy (GET) in Myalgic Encephalomyelitis (ME)/Chronic Fatigue Syndrome (CFS): CBT/GET is not only ineffective and not evidence based, but also potentially harmful for many patients with ME/CFS. Neuro Endocrinol Lett. 2009 Aug 26;30(3):284-299.) click here

The NICE guidelines need complete revision* as their current version is far from evidence-based.

The NICE guidelines have been shown to be ineffectual, biased, unusable, with ME patients eventually taking NICE to a judicial review.

For an organisation to support NICE, and require members to abide by them, let alone “champion” them illustrates a flawed and damaging basis for any claim to represent people with ME and their families. Such an organisation is likely to continue to force a continuing approach of going round in circles, obfuscating the true requirements for ME patients and achieving little of real value for people with ME and their families.

With BACME maintaining its present structure, current chairman and constitution then Invest in ME will decline any offer to apply for membership of this organisation.

It would be unethical of Invest in ME to sign up to such a constitution and Invest in ME’s aim remains to find ways other than those set out in the NICE guidelines to treat patients diagnosed with ME according to the Canadian Clinical Consensus guidelines.

Further Reading: (links provided by Invest in ME)

Magical Medicine: How to Make a Disease Disappear – click here

Lightning Process – The Falsehood of Magical Medicine – IiME Newsletter March 2010 – click here

Can the MRC PACE Trial be justified? – click here

Wessely’s Way: Rhetoric or reason? – click here

Invest in ME – Communications with the UK Chief Medical Officer – click here