Countess of Mar: Questions for Written Answer: Lightning Process pilot study ethical approval

Countess of Mar: Parliamentary Questions for Written Answer: Lightning Process pilot study ethical approval

Shortlink: http://wp.me/p5foE-3bG

http://www.publications.parliament.uk/pa/ld201011/minutes/101022/ldordpap.htm

House of Lords Business

Questions for Written Answer [House of Lords]

Tabled on 21 October and due for answer by 4 November.

[…]

The Countess of Mar to ask Her Majesty’s Government what assessment they have made of whether the decision by the South-West Research Ethics Committee to approve a pilot research study into the effects of the Lightning Process on children is consistent with the ethical guidance issued by the Medical Research Council to the effect that clinical trials should only include children where the relevant knowledge cannot be obtained by research on adults, and that research involving adults cannot provide the same benefits. HL3014

 

Related material

Children should not be used as guinea pigs: Prof Robin Gill, Church Times (Lightning Process Pilot study): http://wp.me/p5foE-3ak

House of Commons: Written answers and statements: Phil Parker Lightning Process: http://wp.me/p5foE-39J

Hansard Citation: HC Deb, 11 October 2010, c87W

11 Oct 2010 : Column 87W

Health
Phil Parker Lightning Process

Written answers and statements, 11 October 2010

Annette Brooke [Mid Dorset and North Poole, Liberal Democrat]: To ask the Secretary of State for Health what representations he has received on the research and development of the Phil Parker Lightning Process.[15725]

Paul Burstow [Minister of State (Care Services), Health; Sutton and Cheam, Liberal Democrat]: The Department has received representations, from individual members of the public and on behalf of chronic fatigue syndrome/myalgic encephalomylitis stakeholder groups, on research proposals associated with the Lightning Process.

————–

Annette Brooke, MP, is Vice-chair of the newly reformed APPG on ME and has been active in a number of Parliamentary Public Bill Committees (formerly known as “Standing Committees”) representing the rights of children and families:

http://www.theyworkforyou.com/mp/annette_brooke/mid_dorset_and_north_poole

ME in Parliament: Written Questions: ME and UK blood ban; Retrovirals and ME research

ME in Parliament: Written Questions: ME and UK blood donor ban; Screening stored blood; Retrovirals and myalgic encephalomyelitis (ME) research

Shortlink: http://wp.me/p5foE-3bx

From the News pages of the ME Association

Parliamentary Questions: the UK blood ban on people with ME/CFS

by Tony Britton  |  19 October 2010

Caroline Lucas, leader of Green Party and MP for Brighton Pavilion, tabled two written questions on the blood ban which is to be imposed on everyone in the UK who has ME/CFS from November 1.

In the first, she asked the Secretary of State for Health on what date his Department’s decision that people with myalgic encephalomyelitis should not give blood was (a) made and (b) implemented.

In her written reply on 19 October 2010, Anne Milton (Parliamentary Under Secretary of State for Public Health) wrote:

The UK Blood Services decision to permanently exclude from blood donation anyone who reports that they have had Myalgic Encephalopathy/Chronic Fatigue Syndrome (ME/CFS) was made on 8 July 2010. The change to the donor selection guidelines will come into force on 1 November 2010.

This change is being made on the grounds of donor safety, as ME/CFS is a relapsing condition. It brings practice for ME/CFS into line with other relapsing conditions or neurological conditions of unknown origin.

The change is being made on the grounds of donor selection criteria by the UK Blood Services Standing Advisory Committee on the Care and Selection of Donors, and Joint Professional Advisory Committee.

In her second question, Caroline Lucas asked the Health Secretary whether – with reference to an answer given to the MP for Stroud on 27 January* whether (a) the UK Blood Services and Health Protection Agency study of the prevalence of a rodent virus linked to ME and (B) his Department’s risk assessment in respect of the study had been completed; and if he will make a statement.

Anne Milton replied:

There has been a consistent failure of independent European and American studies to confirm the original American study that described the detection of xenotropic murine leukemia virus-related virus (XMRV), a virus related to rodent viruses, in patients with chronic fatigue syndrome, sometimes referred to as myalgic encephomyelitis.

An expert subgroup of National Expert Panel for New and Emerging Infections (NEPNEI) met in May 2010, to consider all available evidence about XMRV and conduct a risk assessment. The subgroup concluded that XMRV can infect humans but there is currently no evidence that it causes human disease and that on the evidence before the group, no public health action is required at this time. Since the subgroup meeting in May there has been no new scientific evidence that would change the conclusions of the subgroup but they are keeping it under review.

The Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO), on the basis of current evidence does not recommend further measures at present but wishes to continue to monitor the situation. The NHS Blood and Transplant and Health Protection Agency study group concur with the views expressed both by NEPNEI and SaBTO but also recognise the need for further research on the prevalence of XMRV in the United Kingdom.

In a recent unpublished pilot study conducted by the group a series of 540 randomly selected English blood donors were screened for XMRV and none were found to be infected.

ME Association questions the rationale behind the blood ban – BBC News Report (8 October)

MEA medical adviser, Dr Charles Shepherd, discusses the subject on the BBC R4 ‘Today’ programme

* The 27 January Parliamentary Question

 

From the News pages of the ME Association

Parliamentary Questions: UK blood banks and XMRV

by Tony Britton  |  21 October 2010

The Minister for Public Health, Anne Milton, has responded to related questions from two MPs about what the Department of Health plans to do with blood from people with ME that is held in storage or whether he has any plans to screen blood already held in storage for the XMRV virus.

David Anderson (Labour MP for Blaydon) asked if the Department of Health would be screening blood held in blood banks for the XMRV virus. And Sharon Hodgson (Labour, Washington and Sunderland West) asked whether the Department would be removing from storage blood donated by people with ME.

In her written answer on 20 October 2010, the Minister replied:

There are no plans to screen blood already stored in blood banks for the xenotropic murine leukemia virus-related virus (XMRV) or to remove from storage blood donated by persons diagnosed with myalgic encephalomyelitis.

A recent study in the United States (of America) reported that XMRV has been detected in a number of chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME) sufferers. CFS/ME sufferers can currently give blood when they are well. These data have not been replicated in Europe.

An expert subgroup of National Expert Panel for New and Emerging Infections (NEPNEI) met in May 2010, to consider all available evidence about XMRV and conduct a risk assessment. The subgroup concluded that XMRV can infect humans but there is currently no evidence that it causes human disease and that on the evidence before the group, no public health action is required at this time. Since the subgroup meeting in May there has been no new scientific evidence that would change the conclusions of the subgroup. In July 2010, the Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO), similarly did not recommend further measures at present. Both groups will continue to monitor the situation.

However, from 1 November 2010, CFS/ME sufferers will no longer be able to donate blood. The UK Blood Services recognised that exclusion from donation by people with ME/CFS needed to be brought in line with that from other relapsing conditions for the protection of the donor, and not because of potential infection risks.

Parliamentary Written answers and statements, 21 October 2010

David Anderson (Blaydon, Labour)
David Willetts (Minister of State (Universities and Science), Business, Innovation and Skills; Havant, Conservative)

Hansard source (Citation: HC Deb, 21 October 2010, c867W)

Chronic Fatigue Syndrome

Mr Anderson: To ask the Secretary of State for Business, Innovation and Skills if he will provide funding for research on the relationship between retrovirals and myalgic encephalomyelitis. [18037]

Mr Willetts: The Medical Research Council (MRC) is one of the main agencies through which the Government support medical and clinical research. In keeping with the Haldane Principle, prioritisation of an individual Research Council’s spending within its allocation is not a decision for Ministers. Such decisions are rightly left to those best placed to evaluate the scientific efficacy of proposed research.

The MRC is committed to supporting scientific research into all aspects of ME, including studies into the biological basis of the condition and evaluations of treatments. In 2009/10 the MRC spent £109,000 on research directly relating to ME.

also recorded at:

http://www.theyworkforyou.com/wrans/?id=2010-10-21a.18037.h&s=chronic+fatigue+syndrome

House of Commons: Written answers and statements: Phil Parker Lightning Process

House of Commons: Written answers and statements: Phil Parker Lightning Process

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

House of Commons Written answers and statements

Hansard Citation: HC Deb, 11 October 2010, c87W

11 Oct 2010 : Column 87W

Health

Phil Parker Lightning Process

Written answers and statements, 11 October 2010

Annette Brooke [Mid Dorset and North Poole, Liberal Democrat]: To ask the Secretary of State for Health what representations he has received on the research and development of the Phil Parker Lightning Process.[15725]

Paul Burstow [Minister of State (Care Services), Health; Sutton and Cheam, Liberal Democrat]: The Department has received representations, from individual members of the public and on behalf of chronic fatigue syndrome/myalgic encephalomylitis stakeholder groups, on research proposals associated with the Lightning Process.

Related material:

1] SMILE – Specialist Medical Intervention and Lightning Evaluation documents (Lightning Process pilot study – children [now aged 12 to 18] with CFS and ME): http://wp.me/p5foE-37x

2] ASA adjudication against “Withinspiration”, June 2010:
http://www.asa.org.uk/Complaints-and-ASA-action/Adjudications/2010/6/Withinspiration/TF_ADJ_48612.aspx

3] Background to this issue: http://wp.me/p5foE-2Vt

4] All posts on Lightning Process pilot study in children issue on ME agenda:
https://meagenda.wordpress.com/category/lightning-process-smile-study/

Parliament.uk

http://www.parliament.uk/about/how/business/written-answers/

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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

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

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

Shortlink: http://wp.me/p5foE-36W

Update on the Dr Esther Crawley led Royal National Hospital for Rheumatic Diseases (RNHRD) NHS FT, Bath/University of Bristol Lightning Process pilot study for children aged 8 to 18 (now 12 to 18)[1].

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

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

For joint ME charity opposition statement and press release see:

Joint Press Release and statement: ME Association and The Young ME Sufferers Trust

Source: Protocol document

“Unethical”

A pilot study on the controversial Lightning Process using children as young as eight has received the go ahead from a South West Region Research Ethics Committee (REC), despite widespread public concern and condemnation by two UK national patient organisations.

In August, ME patient charities, The ME Association and The Young ME Sufferers Trust, issued a joint press release describing the study as “unethical” and calling for it to be abandoned [2].

The organisations said:

“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.

“The pilot study, scheduled to start in September, will look at the feasibility of recruiting children aged eight to 18 with ME/CFS into a randomised controlled trial (RCT) comparing the Lightning Process with specialist medical care.

“It is planned that over 90 children aged between eight and eighteen and their families will be involved in the study.

“The Medical Research Council (MRC) produces specific guidelines for research involving vulnerable patient groups [3].

“The document ‘MRC Medical Research Involving Children’ is quite clear on this issue. It poses the question: ‘Does the research need to be carried out with children?’ In answer, the MRC states: ‘Research involving children should only be carried out if it cannot feasibly be carried out on adults.’

“The ME Association and The Young ME Sufferers Trust do not believe that it is ethically right to use children in trialling an unproven and controversial process such as the Lightning Process…

“…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.”

Today, information received from University of Bristol Information Rights Officer, Matthew Morrison, confirms that the pilot study has now been granted ethics approval. Recruitment to the study, which is being funded by the Linbury Trust and the Ashden Trust, was scheduled to start in September.

 

What has been published?

A large number of documents are published today on the University of Bristol website.

Information on accessing the research protocol and other published material can be found in the next post.

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

 

Advertising Standards Authority (ASA) ruling

In June, ME agenda reported that Alastair Gibson, who had previously identified himself as one of two Lightning Process coaches involved with the NHS study, was the subject of an Advertising Standards Authority (ASA) ruling [10].

The ASA upheld a complaint about unsubstantiated claims made for the efficacy of the Lightning Process in ME and CFS in an advertisement for Mr Gibson’s “Withinspiration” company.

At least one Lightning Process company has made changes to the wording on its website following the ME Association’s discussions with Trading Standards.

Currently, the ASA’s remit does not extend to website content but from May 2011, the ASA will broaden its remit and will be able to consider complaints about:

Advertisers’ own marketing communications on their own websites and;

Marketing communications in other non-paid-for space under their control, such as social networking sites like Facebook and Twitter.

On 1 September, the Advertising Standards Authority issued a news release setting out its extended remit: 

Landmark agreement extends ASA’s digital remit (Lightning Process pilot study in children)

 

Department of Health responses

Concerns about the pilot study have been taken up with Earl Howe (Parliamentary Under-Secretary of State for Quality). Earl Howe is a Patron to The Young ME Sufferers Trust. An unsatisfactory response was received from Bill Davidson, Research Governance Manager, Department of Health, on 30 August, who responded on behalf of Earl Howe.

In July, Annette Brooke, MP, Mid Dorset & North Poole forwarded my concerns and documents to the Rt Hon Andrew Lansley MP, Secretary of State for Health, Department of Health. Paul Burstow MP, Minister of State for Care Services, responded briefly on behalf of the Secretary of State for Health, on 12 August.

Mrs Brooke is Vice-chair of the newly reformed APPG on ME (Acting chair, David Amiss, MP).

The ME Association had also written to the Department of Health requesting that their joint press release be forwarded to the ethics committee reviewing the application. The DoH refused to do so – a decision which the ME Association considered unacceptable.

The name of the South West Research Ethics Committee, which had met to review the application on 8 July, was identified on 27 August in a response to my request for information under the Freedom of Information Act. The contact details for this regional RE committee chair have been passed to the ME Association.

The South West Regional Manager for the National Research Ethics Service (NRES) confirmed to me, in May, that there is apparently no process through which REC decisions might be challenged by the public.

 

References:    

[1] Press Release, University of Bristol, 2 March 2010
Media article

[2] Joint Press Release and statement: ME Association and The Young ME Sufferers Trust

[3] MRC Guidelines Medical Research Involving Children (Nov 2004, revised Aug 2007)   

[4] Request for information under FOI and FOI Office responses  

[5] Action for M.E. article on Lightning Process, InterAction magazine, March 2007   

[6] Patient Survey 2008, Action for M.E. and AYME   

Patient Survey May 2010, ME Association  

[7] LP Doesn’t Work for ME: Personal accounts from LP “trainees”

Letter: Lightning process for ME didn’t work for me

Personal account of Lightning Process technique as applied to patient with ME

Personal account of Lightning Process as applied to patients with ME and MS  

[8] Sample Lightning Process application form

[9] ASA adjudication against “Withinspiration” 

[10] RNHRD Bath Chronic Fatigue Syndrome/ME Service for Children & Young People

[11] Lightning Process website

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

Lightning Process: further statement from ME Association and Young ME Sufferers Trust

Lightning Process: further statement from ME Association and Young ME Sufferers Trust

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

Lightning Process: further statement from ME Association and Young ME Sufferers Trust

Wednesday, 01 September 2010 09:08

On 4 August 2010 The ME Association and The Young ME Sufferers Trust (Tymes Trust) issued a joint statement that expressed a number of concerns about the proposal to carry out a feasibility study, involving children and adolescents with ME/CFS, into the use of the Lightning Process.

The statement can be read here.

We also sent a copy of this statement to the Department of Health with a request that it should be forwarded to the ethics committee that will be examining this proposal. This is because we believe the ethics committee should be aware of widespread concerns being expressed by people with ME/CFS about the trial. Our statement also contained information about an adjudication from the Advertising Standards Authority and interventions by several trading standards officials – both in relation to therapeutic claims being made for the Lightning Process which we believe the ethics committees must be aware of when reviewing this proposal.

The Department of Health have refused to forward this information to the ethics committee on the grounds that

“We expect research ethics committees to consider all the relevant evidence, but they have to be seen do so objectively and impartially and to arrive at their decisions independently if they are to command public confidence and the credibility of all the stakeholders concerned. For this reason, it would be inappropriate, as well as potentially counterproductive, expressly to bring your joint statement to the attention of the research ethics committee reviewing the proposal for this project..”

We profoundly disagree with the DoH’s reasoning, which we consider carries serious implications for the integrity of the scientific process. Whether or not an ethics committee membership is confidential, it should still be possible for essential evidence to be supplied to them. How else can the public be assured that an ethics committee has all the relevant evidence to consider before reaching its decision?

The two charities are unable to forward this statement direct because the identity and location of the relevant ethics committee is not in the public domain.

We are now considering what further action to take.

[Ends]

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

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

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

or http://tinyurl.com/ReviewIiMEProposalText

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

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

 

TEXT VERSION

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

By Chris Douglas

27 August 2010

Introduction

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

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

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

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

1. Scope

1.1. Geographic Scope

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

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

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

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

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

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

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

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

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

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

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

1.2. Disease Scope

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

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

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

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

Page 3 

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

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

2. Objectives

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

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

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

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

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

Clinical objectives could include:

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

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

Research objectives could include:

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

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

Page 4

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

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

3. Service Provision Model

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

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

Fig 1. Overview of assumed service provision model

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

Page 5

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

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

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

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

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

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

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

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

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

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

For the charity and steering group specifically:

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

Page 6

For IiME Ltd specifically:

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

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

4. Funding

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

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

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

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

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

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

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

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

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

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

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

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

Page 7

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

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

5. Conflicts of Interest

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

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

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

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

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

Page 8

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

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

References

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

2 EDP24 “Norwich centre for ME sufferers planned” 03.08.10

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

 

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

douglas_chris@hotmail.co.uk

© Chris Douglas 2010

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

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

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

or http://tinyurl.com/ReviewIiMEProposal

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

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

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

 

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

By Chris Douglas

27 August 2010

Introduction

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

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

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

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

Open Word document here: Norfolk Proposal Review 27.08.10

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

 

Related information

Invest in ME

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

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

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

Invest in ME

A UK Centre for Biomedical Research into ME

Read the announcement here

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

       Biomedical Research Institute Proposal July 2010

“A New Era in ME/CFS Research 

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

“A VISION FOR THE FUTURE

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

 

Media coverage

Great Yarmouth Mercury

Hopes for ME centre in Norfolk raised

31 August 2010

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

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

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

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

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

———————

Norwich Evening News

Plans for world class Norfolk centre

Sarah Hall  |  27 August 2010

———————

Environmental Illness Resource Blog

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

News – Chronic Fatigue Syndrome News

Matthew Hogg  |  13 August 2010

———————

EDP24

Norwich centre for ME sufferers planned

Sarah Hall  |  3 August 2010

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

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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”

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(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