Ian Swales, MP amends his understanding of government policy on CFS and ME

Ian Swales, MP amends his understanding of government policy on CFS and ME terminology (Three Parliamentary errors)

Shortlink Post: http://wp.me/p5foE-3hH

On 2 February 2011, Ian Swales (Lib Dem, Redcar) addressed a Parliamentary Adjournment Debate on ME. During that debate, the Health Minister, Paul Burstow, had stated that the World Health Organisation (WHO) uses the composite term CFS/ME for this condition.

This was incorrect. The WHO does not use the composite terms “CFS/ME” or “ME/CFS”.

In a Parliamentary Written Answer to Mr Swales, dated 16 February, the Health Minister corrected his error [1].

Mr Burstow had clarified:

“…During the Westminster Hall debate, on 4 February 2011, I said that the World Health Organisation uses the composite term CFS/ME for this condition. This was incorrect.

“The World Health Organisation classes benign myalgic encephalomyelitis and post viral fatigue syndrome under the same classification G93.3 ‘diseases of the nervous system’; subheading ‘other disorders of the brain’.

“The report of the CFS/ME Working Group to the Chief Medical Officer, in January in 2002, suggested that the composite term CFS/ME be used as an umbrella term for this condition, or spectrum of disease. This term is also used by the National Institute for Health and Clinical Excellence for their clinical guidelines.

“We do, however, intend to seek further advice on our classification and will update the hon. Member in due course.”

[Note that although Health Minister, Paul Burstow, gave the date of Ian Swales’ Adjournment Debate as “4 February” in his Written Answer of 16 February, the Debate took place on 2 February 2011.]

On 17 February, Mr Swales published a report on his website which went out under the title “Swales wins battle with Government on ME”. This report had claimed:

“Ian Swales MP’s fight for better treatment of myalgic encephalomyelitis (ME) continues as he succeeds in getting the Government to recognise ME and Chronic Fatigue Syndrome (CFS) as different illnesses.”

But Mr Swales had misinterpreted the content of the Written Answer he had received from the Health Minister.

This has caused much confusion amongst ME and CFS patients.

Advocates have raised this misunderstanding with Mr Swales and with his Parliamentary Researcher.

Today, an amended report has been published on Mr Swales’ website under the same URL and date, but with a new title – this time it is called:

“Swales corrects Minister on World Health Organisation definition of ME”

I am appending both versions.

To recap, because this is important, and because there is a further error:

Paul Burstow, Health Minister, incorrectly stated on 2 February, during an Adjournment Debate, that the WHO uses the composite term CFS/ME for this condition. That error was corrected by Mr Burstow in his Written Answer of 17 February.

Ian Swales, MP, then claimed in a website report that he had succeeded in getting the government to recognise ME and Chronic Fatigue Syndrome (CFS) as different illnesses. This was a misinterpretation of Mr Burstow’s own correction and clarification. Mr Swales’ Parliamentary Office has now amended his report.

The Countess of Mar, meanwhile, tabled a Written Question of her own for which a response was provided on 1 March, by Earl Howe [3].

The Countess of Mar had tabled:

“To ask Her Majesty’s Government, further to the statement by the Minister of State for Health, Paul Burstow, on 2 February (Official Report, Commons, col. 327) that the World Health Organisation (WHO) described myalgic encephalomyelitis (ME) as Chronic Fatigue Syndrome/myalgic encephalomyelitis (CFS/ME) and that this was the convention followed by the Department, in light of the fact that the WHO International Classification of Diseases 10 lists ME as a neurological disease with post viral fatigue syndrome (PVFS) under G93.3 and CFS as a mental health condition under F48.0 and that the latter specifically excludes PVFS, whether they will adhere to that classification.”

The response received on 1 March, was:

Earl Howe (Parliamentary Under Secretary of State (Quality), Health; Conservative)

“The department will continue to use the composite term chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) for this condition, or spectrum of disease, as suggested by the Chief Medical Officer in his 2002 report. We recognise the condition as neurological in nature.”

But the Countess of Mar’s Written Question also contains an error.

In the International version of ICD-10 (the version used in the UK and over 110 other countries, but not in the US which uses a “Clinical Modification” of ICD-9), CFS is not classified as a mental health condition under F48.0.

Chronic fatigue syndrome is listed in ICD-10 Volume 3: The Alphabetical Index, where it is indexed to G93.3, the same code as Postviral fatigue syndrome.

So in International ICD-10, Postviral fatigue syndrome, Benign myalgic encephalomyelitis and Chronic fatigue syndrome are all three coded or indexed to G93.3 under “G93 Other disorders of brain”, in Chapter VI (6): Diseases of the nervous system.

In International ICD-10, the Mental and behavioural disorders chapter is Chapter V (5).

http://www.who.int/classifications/apps/icd/icd10online/?gf40.htm+f480

Chapter V (5) Mental and behavioural disorders

Neurotic, stress-related and somatoform disorders are coded between (F40-F48)

Neurasthenia
Fatigue syndrome

are classified under (F40-F48) at F48.0, which specifically Excludes

malaise and fatigue ( R53 )

and

postviral fatigue syndrome ( G93.3 )

So now you know what UK government policy is and that Mr Swales had misled himself.

The forthcoming US specific ICD-10-CM

Perhaps the focus can now return to more pressing issues – like the fact that in the US, a Partial Code Freeze is looming for the forthcoming US specific version of ICD-10, known as “ICD-10-CM”.

Under longstanding proposals, the committees developing ICD-10-CM intend to retain Chronic fatigue syndrome in the R codes, and code it under R53 Malaise and fatigue, at R53.82 Chronic fatigue syndrome (NOS), but propose to code for PVFS and ME in Chapter 6, under G93.3.

The R codes chapter (which will be Chapter 18 in ICD-10-CM) is the chapter for

“Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified (R00-R99)”

“This chapter includes symptoms, signs, abnormal results of clinical or other investigative procedures, and ill defined conditions regarding which no diagnosis classifiable elsewhere is recorded.”

Coding CFS patients under R53.82 will consign them to a dustbin diagnosis: there are no guarantees that clinicians will use the unfamiliar ME code or that insurance companies will reimburse for G93.3. It will make patients more vulnerable to the proposals of the DSM-5 Somatic Symptom Disorders Work Group. It will mean that ICD-10-CM will be out of line with at least four versions of ICD-10, including the Canadian “Clinical Modification”, and also out of line with the forthcoming ICD-11, where all three terms are proposed to be coded in Chapter 6 Diseases of the nervous system.

There are only seven months left before the 1 October Code Freeze and the clock is ticking.

 

Here is the first version of Mr Swales’ website report, followed by his amended version.

Version One:

http://ianswales.com/en/article/2011/455560/swales-wins-battle-with-government-on-me

Swales wins battle with Government on ME

February 17, 2011 3:45 PM

Ian Swales MP’s fight for better treatment of myalgic encephalomyelitis (ME) continues as he succeeds in getting the Government to recognise ME and Chronic Fatigue Syndrome (CFS) as different illnesses.

During Ian’s recent parliamentary debate on ME he argued that the Government needs to distinguish between Chronic Fatigue Syndrome and ME to provide better treatment for the different illnesses.

However, Health Minister Paul Burstow MP responded by saying that the World Health Organisation classifies Chronic Fatigue Syndrome and ME as the same illness.

Following an outcry from the ME community about this statement, Ian challenged the Minister on his definition of CFS/ME. The Minister admitted that the definition he used in the debate was “incorrect”.

Commenting, Ian Swales MP said:

“I am pleased that the Government has now recognised that ME and Chronic Fatigue Syndrome are two different illnesses.

“After the debate I received a lot of correspondence from the ME community about the Government’s definition of CFS/ME, so after doing some more research on the matter I decided it was right to clarify this point with the Minister. I know they will be reassured by this news.

“I hope that approaching ME as a distinct condition will help lead to better, more effective treatment for sufferers through better analysis of their possible different causes and symptoms.”

[Ends]

Version Two:

http://ianswales.com/en/article/2011/455560/swales-wins-battle-with-government-on-me

Swales corrects Minister on World Health Organisation definition of ME

February 17, 2011 3:45 PM

Ian Swales MP’s fight for better treatment of myalgic encephalomyelitis (ME) continues as he succeeds in getting the Government to acknowledge that the World Health Organisation does not use the composite term CFS/ME for the condition.

During Ian’s recent parliamentary debate on ME he argued that the Government needs to distinguish between Chronic Fatigue Syndrome and ME to provide better treatment for the different illnesses.

However, Health Minister Paul Burstow MP responded by saying that the World Health Organisation “uses the composite term CFS/ME for the condition”.

Following an outcry from the ME community about this statement, Ian challenged the Minister on his definition of CFS/ME. The Minister admitted that his statement was “incorrect”.

Commenting, Ian Swales MP said:

“I am pleased that the Minister has acknowledged the error he made in the debate.

“After the debate I received a lot of correspondence from the ME community about the Government’s definition of CFS/ME, so after doing some more research on the matter I decided it was right to clarify this point with the Minister. I know they will be reassured by this news.

“I will continue my campaign to get more effective treatment for sufferers of ME through better analysis of its causes and symptoms.”

[Ends]

The text of the Adjournment Debate can be read here, on Hansard
2 Feb 2011 : Column 323WH

Myalgic Encephalomyelitis
4.13 pm

Watch video, here, on BBC News:

http://news.bbc.co.uk/democracylive/hi/house_of_commons/newsid_9382000/9382412.stm

 

References:

[1] Written Answer: Paul Burstow to Ian Swales, 16 February 2011, 16 Feb 2011 : Column 864W:
http://www.publications.parliament.uk/pa/cm201011/cmhansrd/cm110216/text/110216w0004.htm

[2] Amended Ian Swales website report:
http://ianswales.com/en/article/2011/455560/swales-wins-battle-with-government-on-me

[3] Written Answer: Earl Howe to The Countess of Mar, 01 March 2011:
http://www.theyworkforyou.com/wrans/?id=2011-03-01a.297.1

Hansard for above:
http://www.publications.parliament.uk/pa/ld201011/ldhansrd/text/110301w0001.htm#11030162000766

[4] Hansard, House of Lords Debate: Myalgic Encephalomyelitis, 22 January 2004:
http://www.publications.parliament.uk/pa/ld200304/ldhansrd/vo040122/text/40122-12.htm

[5] Current codings in ICD-10 for Postviral fatigue syndrome; [Benign] myalgic encephalomyelitis and Chronic fatigue syndrome:
http://dxrevisionwatch.wordpress.com/icd-11-me-cfs/

Summary MEA Board of Trustees meeting 15-16 November 2010: Lightning Process

Extract from Summary of the ME Association meeting of the Board of Trustees which was held on 15 and 16 November and at which the issue of the controversial Bath/Bristol Lightning Process pilot study in children was discussed.

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

http://www.meassociation.org.uk/?p=3059

Summary of the MEA Board of Trustees meeting, November 2010
by tonybritton on November 20, 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, November 15th and on Tuesday morning, November 16th.

Informal discussion on some of the topics also occurred on the Monday morning.

This is a summary of the two 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.

[…]

Lightning Process:

Trustees held a further discussion on a controversial 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 and objections have been raised about the possible use of children and adolescents in this type of study and we are discussing these concerns 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: http://www.meassociation.org.uk/?page_id=1341

This statement 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 but the DoH refused to do so. Following a Freedom of Information request we obtained the identify the ethics committee that was dealing with the application and our statement was then forwarded to the Chairman. Unfortunately, due to initial secrecy surrounding the identity of the ethics committee, the information did not reach them till after the application had been approved.

We have also passed our concerns to the National Research Ethics Service, who are considering whether the local ethics committee should review their decision. More information can be found on the MEA website: http://www.meassociation.org.uk/?p=2720

A BBC radio discussion from Thursday 11 November about the Lightning Process – which included contributions from Professor Leslie Findley, Dr Charles Shepherd and Phil Parker and was chaired by Anne Diamond – can be heard on YouTube: http://www.meassociation.org.uk/?p=2921. A transcript is also available on the MEA website.

[Extract ends]

 A few points:

The Bath/Bristol press release announcing the pilot study was published on 2 March 2010.

The ME Association and The Young ME Sufferers Trust did not issue a joint statement and press release condemning the pilot study until five months later, on 4 August.

Under FOI (in a response dated 27 August) I established that the REC responsible for reviewing the application was the South West 2 Research Ethics Committee. This information was provided by Jonathan Cramp, FOI Manager, NHS South West.

This information had been requested by me of the University of Bristol on 15 May but was denied in a response of 17 June.

It was denied a second time following a request for an Internal Review of the University’s decision to withhold almost all information that had been requested by me under the FOIA. The Internal Review was handled by Sue Paterson, Director of Legal Services and Deputy Secretary, Office of the University Secretary, from whom a response was received on 17 August.

Within the response of Jonathan Cramp, FOI Manager, NHS South West, was the information that the application for ethics approval had been received on 14 June 2010 and that South West 2 RE committee had met to consider the application on 08 July 2010.

As soon as I had received confirmation of the name of the REC which had (already) reviewed the application, this was passed to the ME Association, who had also been passed all previous communications I had been having with various FOI offices, with various parliamentarians, with the Department of Health and with the South West Regional Manager, National Research Ethics Service.

As recorded in the MEA’s meeting summary, above, it was the case that by the time it had been established which RE committee had reviewed the application for ethics approval, the committee had already met six or seven weeks previously (although a favourable opinion was not handed down until mid September since the CI had been asked to revise some content of the patient literature and also address other areas of concern which delayed a decision).

When the MEA and TYMES Trust did issue a statement on 4 August, condemning the pilot and calling for the study to be abandoned, this was widely welcomed, as has been the ME Association’s initiative in contacting Trading Standards offices, as is their continued interest in this issue.

It remains unclear, though, and of concern to me, why these two patient groups took five months to issue position statements and a joint press release.

RNHRD NHS FT Bath/University of Bristol Lightning Process pilot study in children 12 to 18 (SMILE study): Minutes of meeting of External Advisory Group held on 02.11.10: http://wp.me/p5foE-3er

Transcript BBC Radio Berkshire Anne Diamond Show, broadcast 11 November 2010: http://wp.me/p5foE-3dG

Related information:

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

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

Minutes Forward-ME meeting, 26 October 2010: Lightning Process trial involving children

Minutes Forward-ME meeting, 26 October 2010: Lightning Process trial involving children

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

Forward-ME is a caucus group to the All Party Parliamentary Group on ME (APPG on ME) convened and chaired by the Countess of Mar.

The most recent meeting of the group was held in October in a meeting room within the House of Lords and the issue of the SMILE Lighting Process pilot trial was tabled on the Agenda at Item 6.2. The following is an extract from the Minutes of that meeting:

http://www.forward-me.org.uk/26th%20October%202010.htm

Minutes of the meeting held on

TUESDAY 26 OCTOBER 2010

1.00 PM

HOUSE OF LORDS.

1. Present:

Jane Colby – TYMES Trust
Christine Harrison – BRAME
Bill and Janice Kent – ReMEmber
Peter Spencer – AfME
Charles Shepherd – MEA
Sue Waddle – MERUK

Margaret Mar – Chairman

Mary-Jane Willows – AYME

2. Apologies:

Tanya Harrison – BRAME

[…]

6.2 Lightning Process trial involving children

The Group were informed that MEA and Tymes Trust had provided a joint statement on the SMILE Trial to Richard Ashby, Chair of the South West ethics Committee, saying that they felt the trial was unethical and that the ethics committee had probably not been made aware that the Advertising Standards Agency had ruled against a claim made by a Lightning Process Practitioner and that trading standards departments had been taking action in relation to misleading therapeutic claims. Concerns about the trial were being assessed by the National Research Ethics Service, headed by Joan Kirkbride.

It was said that an increasing number of individuals were contacting ethics bodies to express concerns about the trial.

The Group was told of a commentary in the Church Times by Prof Robin Gill, Chair of the BMA Ethics Committee, in which he criticised the research, and that Prof Gill planned to take this up with the BMA.

The Chairman had tabled a question asking what the Government’s opinion is on this matter.

(Hansard text)

Christine Harrison asked whether a complaint had been made to the NSPCC regarding the SMILE Trial. Charles Shepherd replied that it had and the content of this could be viewed on the internet.

A discussion followed. Concern was expressed regarding the fact that the study involves research being conducted on children before it was tested on adults. It was recognised that the MRC guidelines stated circumstances under which it would be acceptable to perform a study on children in the first instance. The feasibility study would need to prove that these conditions were satisfied in order to achieve ethical clearance of the actual trial. The Principal Investigator would also have to prove that a robust risk management strategy had been developed to minimise any harm to participants.

Another concern was that the ethics committee seemed not to have been made aware of the ruling made by the Advertising Standards Agency in relation to claims made by a practitioner of the Lightning Process.

The point was made that 250 children a year undergo this treatment and a paediatrician had been approached and asked whether the treatment was safe. However there was a concern that parents who believed they must try everything that might be of benefit to their child could feel pressurised to try the treatment. Children could be very vulnerable to inappropriate pressure to say they felt better.

The Group was told that Dr Esther Crawley, the lead for the LP research, had received a large volume of malicious correspondence about her proposals. The Group agreed that this was not an appropriate or acceptable manner in which to demonstrate opposition and confirmed that none of them had been involved. It was suggested that it was activities such as this that drove young researchers from the field.

The Group was told that the research ethics papers submitted for the feasibility study were on the Bristol University website. Some of these papers made the case that M.E. in children was a different illness from M.E. in adults. It was drawn to the Group’s attention that Dundee University (in a biomedical study co-funded by Tymes Trust and Meruk) had discovered the same abnormalities in the blood of children that they had previously found in adults, so in this respect, ME in children was not a different illness from ME in adults. (See item 11)

The Chairman suggested that it was important to look at the recovery period covered by the study because M.E. was a relapsing condition.

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

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

Response from Joan Kirkbride, NRES (SMILE pilot study in children)

Response from Joan Kirkbride, National Research Ethics Service (complaint in response to ethical approval of SMILE Lighting Process pilot study in children)

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

On Thursday, 4 November, I wrote to Joan Kirkbride, Head of Operations, National Research Ethics Service (NRES).

Re: Concerns in response to the favourable opinion handed down by South West 2 REC in September 2010 to the application from Dr Esther Crawley, Principal Investigator for the SMILE (Specialist Medical Intervention and Lightning Evaluation) pilot study

Study Refs: 10/H0206/32, ASH106264, LIN1750

My letter expanded on some of the concerns I had raised, in August, with the Director of Legal Services, University of Bristol, in a formal request for an Internal Review of the Information Rights Officer’s decision (17 June) to decline to provide certain information on the basis that this information was exempt from disclosure under section 22(1)(a) of the Freedom of Information Act 2000 (information intended for future publication). I also included other concerns.

I gave Ms Kirkbride permission for my concerns to be forwarded, in full, to any individuals charged with the scrutiny of complaints in response to the decision to grant the Lightning Process pilot study ethics approval, within the NRES, within South West 2 REC and including the sponsors, Chief Investigator, co-applicants and study funders.

I requested confirmation that my communication had been received and my concerns noted.

Today, I received an acknowledgement from Ms Kirkbride which she has CCd to a colleague who is understood to be involved with the scrutiny of complaints.

I am advised by Ms Kirkbride that:

She has appended a copy of the standard response which NRES is sending to all respondents on this matter.

That she advises that NRES “do feel that they now have sufficient information available to [them] and that no new issues are being raised in correspondence which is being sent to [them] for consideration”.

That she has copied my email to the Chief Investigator and Sponsor as I had given permission to do so.

That I “had raised a number of specific questions outside the remit of NRES where [they] cannot provide a response and the answer to my questions would need to come from either the CI [Chief Investigator] or the sponsor”.

The standard response being issued by NRES is:

“NRES has received the submissions from the ME society [The ME Association] and others concerning the SMILE study, a children’s study investigating treatment of ME in this age group.

“Following our Standard Operating Procedures we have collated the information we’ve received and will work with the REC to consider it.

“Given that this treatment is currently available, ME society survey data suggests it has a similar profile to other therapies and the split opinions in the ME community (this study has the support of particular ME charities who have also been involved in its planning) we feel that a fair way forward is to seek the responses of the researchers, sponsor and the ME charities involved in the development of the study before asking the REC to review its favourable opinion. We also note that in this project, subjects will not be deprived of what is current care in this clinic. Research participants will receive this intervention in addition to their standard treatment.

“We will also be seeking the views of our National Research Ethics Panel.”

 

I am given to understand that at least two others who wrote to Ms Kirkbride, last week, have received similar responses.

AYME welcomes ethical approval of Bath/Bristol Lightning Process pilot study in children (SMILE)

AYME welcomes ethical approval of Bath/Bristol Lightning Process pilot study in children (SMILE)

November 1, 2010 by Suzy Chapman

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

In the November edition of LINK Newsletter (Issue 40), the Association of Young People with M.E. (AYME) has welcomed the decision by South West 2 Research Ethics Committee to grant ethical approval for the controversial pilot study around the application of the Lightning Process in children as young as 12.

Lead researcher for the SMILE study (Specialist Medical Intervention and Lightning Evaluation), Dr Esther Crawley,  is AYME’s Medical Consultant.

To date, no rigorous RCTs have been undertaken into the safety, acceptability, short and long-term efficacy of the Lightning Process in adults.

In a joint press release issued in August, two national ME patient organisations – The ME Association and The Young ME Sufferers Trust –  condemned the study as “unethical” and called for the project to be abandoned.

In a position statement issued in March, Action for M.E. had said it saw “no reason to oppose this pilot study”.

But in August, Sir Peter Spencer, CEO of Bristol based Action for M.E., disclosed that “Action for M.E. has not seen the research protocol for this proposal and has no detailed knowledge of the way in which this trial would be conducted if approved.”

Sir Peter Spencer is a non-executive director of the Royal National Hospital for Rheumatic Diseases, NHS Foundation Trust – Dr Esther Crawley’s employer and the hospital where this research study is being undertaken.

The study hopes to recruit around 90 children aged between 12 to 18 and is expected to start this month. Half the patient cohort will undergo a three day course of the Lightning Process.

According to the NHS REC IRAS application form, the SMILE study Protocol and other SMILE study documents published on the University of Bristol website in September:

“Ethical issues   The Lightning Process is popular with over 250 children with CFS/ME attending courses each year. There is therefore an urgent need to study this intervention properly.”

“There are currently no reported studies investigating the effectiveness or side effects of the Lightning Process in children. As with all interventions, proper evaluation is necessary if it is to be brought into mainstream practice.”

“CFS/ME is different in children and adults with different risk factors [15-17], course and outcome [18]. It is therefore not possible to complete a study in adults and extrapolate the results to children.”

“The need for doing a study properly evaluating the Lightning Process came from patients and service users. Representatives from the Association of Young people with ME (AYME) have read, and suggested changes to the protocol and methodology. Service users publicized the research project and are keen to disseminate the findings.”

“The PIS [Participant Information Sheet] follows the NRES recommended layout and has adopted the NRES recommendations for children. We have also tested the PIS on healthy teenagers who reported that it was clear to read. Members of the patient charity AYME have scrutinised the PIS and also felt it was clear to read.”

“Healthy teenagers have scrutinized the patient information sheets and consent forms. The Chief Executive of AYME will be on the External Advisory Group.”

“As this is only a feasibility study, participants will not be individually informed of the outcome. However, the results from the feasibility study will be disseminated through patient charities.”

In a response to the ME Association, published on 28 October, Joan Kirkbride, Head of Operations, NRES (National Research Ethics Service), has written:

“Given that this treatment is currently available, ME Association survey data suggests it has a similar profile to other therapies and the split opinions in the ME community (this study has the support of particular ME charities who have also been involved in its planning), we feel that a fair way forward is to seek the responses of the researchers, sponsor and the ME charities involved in the development of the study before asking the REC to review its favourable opinion.”

I have submitted a FOI request, due for fulfilment on or before 25 November, for the provision of:

1] The names of all patient organisations who have been involved in the planning/development of the SMILE pilot study.

2] The names of all members of the External Advisory Group and the organisations with which they are associated, where applicable.

AYME LINK Issue 40

www.aymelink.org

November 2010

Association of Young People with M.E.

Research study to investigate a chronic childhood condition

A favourable Ethical opinion has been given to a feasibility study which will see if it is possible to look at two different approaches to the intervention and treatment of chronic fatigue syndrome/ME (CFS/ME) in children.

The project called SMILE (Specialist Medical Intervention and Lightning Evaluation) aims to find out if it is feasible 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 research team will be led by AYME’s medical advisor, Dr Esther Crawley, Consultant Senior Lecturer in the University of Bristol’s Centre for Child and Adolescent Health and Consultant Paediatrician at the Royal National Hospital for Rheumatic Diseases NHS Foundation Trust and is funded by the Linbury Trust and the Ashden Trust.

AYME is aware that there are concerns from families about The Phil Parker Lightning Process®.

However, around 250 children a year are already receiving the treatment, and it seems clear that large numbers will continue to do so. Many of the families that AYME supports have asked us about LP and it has been frustrating for us to be able to give them only limited information.

We therefore, welcome this feasibility study to see whether a future study is possible. In addition, AYME is pleased to see the study group are looking at how much health resources young people with ME use and are also investigating the measures clinicians use to look at outcome. If the study is successful, not only will the team be able to apply for funding for a larger study to look at effectiveness, but they will also have a lot of data on the cost of CFS/ME as well as what we need to measure in future research.

It is important to realise that only a larger study in the future will be able to investigate whether LP is effective or not which will enable children and young people and their parents and carers and to make an informed choice about LP. The study is using a mixture of interview techniques to understand what young people think about both interventions, including actually observing and comparing both interventions in order to understand more about them. The fact that all young people will be closely monitored by both the clinical and research team is reassuring.

Esther Crawley said: “We are doing this study because so many young people with ME and their families asked us for this. We are very grateful we can now go ahead and start to answer some of the questions they have been asking”.

The Phil Parker Lightning Process® is an intervention that is used for a variety of conditions including CFS/ME and has been developed from osteopathy, coaching and neuro-linguistic programming. It is a three-day training programme run by registered practitioners and designed to teach individuals a new set of techniques for improving life and health.

Phil Parker, designer of the Lightning Process said: “It is vitally important that all interventions that could assist children with CFS/ME to return to school and improve their health are explored”.

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 has 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, including frequently asked questions can be found at the URL:

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

 

Key SMILE documents

SMILE Research Protocol

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

Open here: smprotv6final

Research Ethics  Application Form

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

Open here: recfrmrfs

All published SMILE documents here:

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

Countess of Mar Written Question on ethical approval of Lightning Process study: Response from Earl Howe

Countess of Mar Written Question on ethical approval of Lightning Process pilot study in children aged 12 to 18: Response from Earl Howe, Parliamentary Under Secretary of State (Quality)

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

House of Lords Business
Questions for Written Answer [House of Lords]

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

House of Lords Written Question

http://www.theyworkforyou.com/wrans/?id=2010-10-28a.311.3&s=speaker%3A12904

The Countess of Mar (Crossbench)

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.

House of Lords Written Answer

Hansard source (Citation: HL Deb, 28 October 2010, c311W)

Earl Howe (Parliamentary Under Secretary of State (Quality), Health; Conservative)

Research ethics committees’ decisions are expected to be impartial and independent of ministerial and other influences. The Government do not interfere with their deliberations, either while they are in progress or by reviewing the outcome. The practice of research ethics committees is subject to training, accreditation and other quality assurance by the arm’s-length National Research Ethics Service to ensure the competence and consistency of their decision-making.

It would be unethical if scientists did not seek to determine the safety and efficacy of treatments and care for all intended beneficiaries, male and female, young and old. When considering whether the particular sample of people proposed as research participants is appropriate, research ethics committees have regard to the established ethical principles reflected in the medicines for Human Use (Clinical Trials) Regulations 2004, international and professional codes of practice and guidelines from funding bodies such as the Medical Research Council (MRC), although the research project in question is neither a drug trial nor funded by the MRC.

Changes to ME agenda WordPress site

Changes to ME agenda WordPress site

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

Yesterday, I posted a House of Lords Written Question that has been tabled by the Countess of Mar, on 21 October, in which questions are raised about the ethical approval of the Dr Esther Crawley led Lightning Process pilot study in children. A Written Answer is expected on 4 November and I shall publish that answer here.

There have also been some developments with the National Research Ethics Service (NRES) which I am not involved in, myself, but I will report on those developments as more information becomes available.

I maintain several WordPress sites and I shall continue to post alerts on this site to new material published on my Dx Revision Watch site – the concept for which developed out of research and awareness raising undertaken throughout 2009 around the forthcoming revisions of two important international disease classification systems: the (APA) American Psychiatric Association Diagnostic and Statistical Manual (DSM) and the World Health Organization International Statistical Classification of Diseases and Related Health Problems (ICD).

Other than that, I do not intend to post further material on ME agenda site.

I don’t like the nonsense that passes for rational discourse so often in our society. I am very much bothered by the inaccuracies, ambiguities, code words, slogans, catch phrases, public relation devices, sweeping generalizations, and stereotypes, which are used (consciously or otherwise) to influence people.

I am bothered by the inability of many to recognize these for what they are. I am bothered by the way people fudge issues, or are unable to clarify them, sometimes because they are inhibited by “collegiality” and other forms of intimidation (sometimes subtle, sometimes not). Most people put up with the nonsense without doing anything about it (unable or unwilling, for whatever reason – inertia, lack, of energy, lack of interest, lack of time, etc.), often falling into cynicism and despair.

I am bothered by the misinformation which gets disseminated uncritically through the media and by the obstructions which prevent correct information from being disseminated. These obstructions come about in many ways – personal, institutional, through self-imposed inhibitions, through external inhibitions, through outright dishonesty, through incompetence – the list is a long one.

I am bothered by the way misinformation, disguised as scholarship, is used in social, political, and educational contexts to affect policy decisions.

I am bothered by the way misinformation is accepted uncritically, and by the way people are unable to recognize it or reject it.

              Serge Lang The File: Case Study in Correction 1977-1979 (1981)

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 and CFS in Parliament: Term dates, APPG on ME and Lightning Process pilot study, Written Question, new EDM

ME and CFS in Parliament: Term dates, APPG on ME and Lightning Process pilot study in children, Written Question, new EDM

Shortlink: http://wp.me/pKrrB-Qf

A compilation of Parliamentary related items

House of Commons Recess dates 2010-11 (Note: All recess dates are provisional)

House of Commons

State Opening: 25 May 2010

Conference Recess: House Rises: 16 September 2010 House Returns: 11 October 2010

Christmas Recess: House Rises: 21 December 2010 House Returns: 10 January 2011

Half term to be confirmed

Easter to be confirmed

APPG on ME

The reconvened APPG on ME had been expected to hold a planning meeting in September. I cannot confirm whether and when a planning meeting took place.

Today, I have written to David Amess MP (Acting Chair, APPG on ME), Annette Brooke MP (Vice-Chair, APPG on ME), APPG on ME ME Association Secretariat and Jane Colby (The Young ME Sufferers Trust).

I have requested that the controversial issue of the Bath/Bristol Lightning Process pilot study in children (which for which ethics approval was obtained in September and for which the study protocol and related documents were published on 16 September) is going to be tabled for discussion at the first meeting of the APPG on ME, on whatever date this takes place. If this is not being tabled for discusion I have requested that it be added to the Agenda.

The following have been advised: Invest in ME; 25% ME Group; RiME, Sue Waddle (rep for ME Research UK) and BRAME.

I took the opportunity of thanking Annette Brooke, again, for raising this issue with Rt Hon Andrew Lansley, MP, Secretary of State for Health and also for tabling the Parliamentary Question for which a response was received from Paul Burstow, MP, Minister of State (Care Services), on 11 October.

I also thanked the ME Association and The Young ME Sufferers Trust for their very strong opposition statements, their joint press release and for their representations to the Department of Health and to the Chair of South West 2 Research Ethics Committee.

I will confirm whether this issue is being tabled for discussion at the next meeting of the APPG on ME, which is expected to be held in November but for which a date has yet to be confirmed.

 

New EDM

An EDM (Early Day Motion) has been tabled by Ian Swales MP (LibDem Redcar). It is understood that this results out of lobbying by Jan Laverick and a family member.

EDM 778

MYALGIC ENCEPHALOMYELITIS
11.10.2010

Swales, Ian

That this House notes that despite the fact that the Department of Health now accepts myalgic encephalomyelitis (ME) as a genuine medical condition, diagnosis can still pose a problem because ME symptoms are similar to those present in a number of other medical conditions; recognises that one of the main obstacles to the adequate treatment of ME is the lack of knowledge and consensus about the disease; believes that funding and research must be focused on the bio-medical factors involved and not just simply managing the psychological symptoms; requests that the Government establishes an independent scientific committee to oversee ME research; and calls on the Government and the Medical Research Council to work with ME sufferers and bio-medical researchers in order to achieve a proper understanding of the condition’s challenges and unjust perceptions of the condition.

At 14 October, 18 MPs had signed up to the EDM. Follow its progres, here, where signatures of supporting MPs are listed:

EDM 778 MYALGIC ENCEPHALOMYELITIS

Ian Swales MP maintains a Facebook page here: Ian Swales (Liberal Democrat) for Redcar on Facebook

What are Early Day Motions?

Early day motions (EDMs) are formal motions submitted for debate in the House of Commons. However, very few EDMs are actually debated. Instead, they are used for reasons such as publicising the views of individual MPs, drawing attention to specific events or campaigns, and demonstrating the extent of parliamentary support for a particular cause or point of view.

More information on the nature and purpose of EDMs, here, on the Parliament website

 

Contacting MPs

For contact details for MPs go to this page on the Parliament website:

http://www.parliament.uk/mps-lords-and-offices/

or here on They Work for You: http://www.theyworkforyou.com/

Find out about your new MP/ MSPs/ MLAs

Read debates they’ve taken part in, see how they voted, sign up for an email alert, and more.

They Work for You links to:

The most recent Commons debates

The most recent Westminster Hall debates

The most recent Written Answers

The most recent Lords debates

The most recent Written Ministerial Statements

 

Written answers and statements, 13 October 2010 [2]

Written answers and statements
Hansard source (Citation: HC Deb, 13 October 2010, c347W)

Work Capability Assessment: Chronic Fatigue Syndrome

Margaret Curran (Labour, Glasgow West): To ask the Secretary of State for Work and Pensions whether the agency contracted to provide medical examinations as part of the Work Capability Assessment has been issued with specific guidance on the assessment of persons presenting a diagnosis of myalgic encephalomyelitis or chronic fatigue syndrome. [14304]

Chris Grayling (Minister of State for Employment): All health care professionals working for Atos Healthcare are required to read an evidence based protocol on chronic fatigue syndrome as part of their induction training. This was last updated in January 2010. In addition, all health care professionals are required to engage in a programme of continuing medical education which includes two modules on chronic fatigue syndrome. These were last updated in April 2009 and March 2010 respectively.

Related information

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

[2] Information on tabling Parliamentary Questions:
http://www.parliament.uk/documents/commons-information-office/p01.pdf

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

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

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

ME Association report followed by full Hansard transcript

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

ME Association News page

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

————-

Full Hansard transcript

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

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

11 Oct 2010 : Column 379

Health: Neurological Conditions
Question for Short Debate

6.09 pm

Asked By Baroness Gardner of Parkes

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

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

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

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