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/

Update on NRES scrutiny of complaints received in relation to ethics approval of SMILE LP pilot study

Update on NRES (National Research Ethics Service) scrutiny of complaints received in response to the granting of ethics approval for the Dr Esther Crawley led Bath/Bristol SMILE Lightning Process pilot study using children and young people with ME and CFS

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

Update: Letter issued today by National Research Ethics Service:

Open PDF here: 05.01.11 Letter SMILE

 

Yesterday, I wrote to Joan Kirkbride (Head of Operations, England National Research Ethics Service (NRES), National Patient Safety Agency) to ask whether there is a date by which she anticipates contacting those who have written to her in connection with the SMILE Pilot study with an update on the progress of the scrutiny of complaints and concerns.

Ms Kirkbride has confirmed to me, today, that she plans to issue a letter this week.  I will update when this letter has been received.

Because there is no formal procedure through which decisions of Research Ethics Committees can be challenged, this exercise undertaken by the NRES in response to the considerable number of complaints received is not a process open to public scrutiny.

The “standard response” being issued by Ms Kirkbride in October and November in response to the receipt of complaints had been:

“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  [The 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. 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.”

Complaints were being passed by Ms Kirkbride to am NRES colleague and to Dr Esther Crawley where permission had been given for communications to be forwarded. 

The study, which was granted ethics approval by South West 2 REC in September, last year, was expected to start recruiting last September. According to documents obtained under the FOIA, the study funders, The Linbury Trust and The Ashden Trust, had stipulated that the study must begin by October latest.

A meeting of the SMILE Pilot External Advisory Group, for which the patient organisation AYME has a seat, was held on 2 November. A copy of the Minutes of that meeting is posted on the website of the University of Bristol website, on the dedicated page for the SMILE Pilot study or open a PDF here on ME agenda: Minutes SMILE Pilot External Advisory Group 02.11.10

Under AOB (Any Other Business):

“1. SL asked how the study was going to date. EC replied that recruitment was going well, parents and teenagers appeared to be enthusiastic and there was a higher recruitment rate then envisioned.

“2. EC informed the group that she needed to respond to complaints made to NRES about the study. She suggested that she drafted a response, discussed this with co-applicants and sent the response to the External Advisory Group before submission. This was agreed.*

“[Action] EC to draft response for NRES, show co-applicants and then send to External Advisory Group before submission.”

 

SMILE Protocol Flowchart and Time plan

Source: Protocol document

 

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/

4] Minutes, meeting of the SMILE Pilot External Advisory Group: 2 November 2010: http://wp.me/p5foE-3er

BMJ takes two months to publish letter on Lightning Process and SMILE pilot study in children

A not very rapid Response: BMJ takes two months to publish letter on Lightning Process and SMILE pilot study in children

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

On 14 July, I submitted a Rapid Response to the BMJ in reply to a response published on 8 March by a Dr Munglani, Consultant in Pain Medicine, West Suffolk Hospital. Dr Munglani had recommended the Lightning Process and given a link to the Lightning Process website in the references at the end of his own Rapid Response to an article about pain management, published in the BMJ in January.

BMJ Rapid Responses usually appear within two or three days following submission and when mine failed to appear on the site, I assumed it had been rejected for publication by the Rapid Response Letters Editor.

In fact, my letter was published by the BMJ but not until 14 September. Why this letter had been held back over two months isn’t known and an enquiry to the Letters Editor has met with no response.

My Rapid Response can be read here on the BMJ site:
http://www.bmj.com/content/340/bmj.b5683.extract/reply#bmj_el_238859

BMJ Original article:

Views & Reviews: From the Frontline: Bad medicine: pain
Des Spence (Published 6 January 2010)
BMJ 340:doi:10.1136/bmj.b5683:
http://www.bmj.com/content/340/bmj.b5683.extract

Rapid Response Re: Failure to appreciate pain is a symptom not a diagnosis is what leads to bad medicine
Suzy Chapman, BMJ (Published 14 September 2010):
http://www.bmj.com/content/340/bmj.b5683.extract/reply#bmj_el_238859

in reply to Rapid Response to article: “From the Frontline: Bad medicine: pain”:

Failure to appreciate pain is a symptom not a diagnosis is what leads to bad medicine, Rajesh Munglani, BMJ (Published 8 March 2010):
http://www.bmj.com/content/340/bmj.b5683.extract/reply#bmj_el_232414

————————–

Between late July and early August, the testimonials by Dr Munglani to which I had referred in my response were taken down from the website of the Rowan Centre. Dr Munglani’s testimonials had read:

“I have been very impressed with the results of the LP. I have seen the lives of some of my patients transformed by this self empowering technique. Everyone who has battled with chronic illness and wants to win should have an opportunity to do the Lightning Process. Professor Rajesh Munglani. MB BS DCH DA FRCA FFPMRCA. Consultant in pain medicine. West Suffolk Hospital and Nuffield Health Cambridge Hospital.”

Between late July and early August, the Rowan Centre ceased offering the Lightning Process and all references to the Lightning Process and Lightning Process logos have been removed from their webpage. They now offer their own flavour of the “process”, known as the “BodyMind Programme”.

See their rationale for distancing themselves from the Lightning Process here:
http://www.simpsonandfawdry.com/about-simpson-and-fawdry.htm

Text on the Rowan Centre website was changed from:

“People using the Lightning ProcessTM have recovered from, or experienced significant improvement with the following issues and conditions…”

to:

http://www.simpsonandfawdry.com/lightning-process.html#lp1

“We have helped people with the following illnesses and conditions…”

Text on their “Introduction” page reads:

http://www.simpsonandfawdry.com/lightning-process.html

“There are now NHS and private consultants, GPs and occupational therapists referring their patients to us at the Rowan Centre. Clinicians in the NHS have observed the work we do. To find out more, you can speak to Gael Postle, Occupational Therapist at the James Paget University Hospital pain clinic on 01493 453307 or the O.T.s at the Norfolk and Suffolk ME/CFS service on 01502 527579.”

The Rowan Centre also offer their programme for MS patients.

Another Lightning Process site which has changed its text since late July is this one:

http://www.x-eed.com/page/services

which has changed:

“What does it work for?

People using the Lightning Process® have also recovered from, or experienced significant improvement with the following conditions:-

Fibromyalgia
Chronic Fatigue Syndrome
Post Viral Fatigue
Asthma
Rheumatoid Arthritis
Hayfever
Depression
Dyspraxia
Bipolar Disorder
Ocd
Anxiety And Panic Attacks
Insomnia
Cerebral Palsy
Low Self Esteem
Parkinsons Tremors
Motor Neurone Disease
Hyper And Hypo Thyroidism
Chronic Aches And Pains
Ibs
Lyme Disease
Anger Issues
Food Intolerances
Coeliac Disease
Ptsd
Candida
Allergies
Type 2 Diabetes
Interstitial Cystitis
Migraines
Noise And Light Sensitivity
And Many More

Using the Lightning Process® has proven effective for clearing ALL the debilitating physical and mind based symptoms of ME, chronic fatigue syndrome, and post viral syndrome.

Some of the symptoms that people have cleared are listed here…”

[long list of conditions]

to “What do we work with?”

[shorter list of conditions]

 

Here’s a site that hasn’t changed its text:

A Manchester and Cumbria practitioner

http://www.helenjames.com/

“The Phil Parker Lightning ProcessTM is a hugely successful training programme which has transformed the lives of thousands of people whose problems had previously seemed impossible to resolve such as Myalgic Encephalomyelitis (ME), Chronic Fatigue Syndrome (CFS), Post-Viral Fatigue Syndrome (PVFS), Fibromyalgia, Multiple Sclerosis (MS), Obsessive Compulsive Disorder (OCD), Anxiety, Depression and many other debilitating issues.

Helen James is a fully qualified Lightning Process Advanced Practitioner, with many years experience in helping people to recover from numerous conditions. For more information about Helen see the About Helen page.

Many people that have already used the Lightning Process to recover from the above conditions had previously tried all sorts of alternative healthcare treatments and complementary therapies, but the only treatment that is consistently helping 1500 suffers a year to recover is the Lightning Process. 85% of people that have the attended a Lightning Process training make a full recovery, and the recovery is permanent.

http://www.helenjames.com/lightningProcess/more

Further applications for the Lightning Process

The Lightning Process can help you to recover from/resolve any of the following…

.Myalgic Encephalomyelitis (ME)
.Chronic Fatigue Syndrome (CFS)
.Post-Viral Fatigue Syndrome (PVFS)
.Fibromyalgia
.Depression
.Obsessive Compulsive Disorder (OCD)
.Overwhelmedness
.Feeling stuck
.Guilt
.Asthma
.Allergies including Hay Fever
.Bipolar Disorder
.Irritable Bowel Syndrome (IBS)
.Food intolerances
.Hyper and Hypo Thyroidism
.Migraines
.Multiple Sclerosis
.Post Traumatic Stress Disorder (PTSD)
.Anger Issues
.Rheumatoid Arthritis
.Anxiety and Panic Attacks
.Perfectionism
.Procrastination
.Coeliac Disease
.Dyspraxia
.Focal Dystonia (undesirable muscular contraction or twisting)
.Insomnia
.Low self esteem
.Lyme Disease also known as Borrelia or Borreliosis.
.Noise and Light Sensitivity
.Torticollis
.Chronic Aches and Pains

And it’s also effective for enhancing:

.Business success
.Peak Sports Performance

http://www.helenjames.com/lightningProcess/multipleSclerosis

Multiple Sclerosis (MS)
Over the last few years we have started to see number of people getting impressive results when using the Lightning Process with other neurological conditions such as CFS, Parkinsonian type tremors, cerebral palsy and strokes. As a consequence we were asked whether the Lightning Process could be used for improvement and recovery with any other types of neurological illness, particularly Multiple Sclerosis…”

 

Landmark agreement extends ASA’s digital remit

In March 2011, the Advertising Standards Authority (ASA) broadens its remit to include website content:

Landmark agreement extends ASA’s digital remit, News release, 1 September 2010

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] 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/

4] Minutes, meeting of the SMILE Pilot External Advisory Group: 2 November 2010: http://wp.me/p5foE-3er

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/

Church Times: Dr Esther Crawley responds to Prof Robin Gill (SMILE Lightning Process pilot study)

Dr Esther Crawley responds to Prof Robin Gill’s letter of concern (Church Times, 8 October 2010) about the ethics of the Bath/Bristol SMILE Lightning Process pilot study

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

On 8 October, Professor Robin Gill had a letter published in the Church Times. A full copy of Prof Gill’s concerns about this pilot study can be read in this posting:

Children should not be used as guinea pigs: Prof Robin Gill, Church Times (Lightning Process Pilot study)

Children should not be used as guinea pigs
Church Times, 8 October 2010

BY: ROBIN GILL

Clinical trials of a training programme for ME, MS, and other conditions raise serious ethical questions, argues Robin Gill.

Canon, Prof Robin Gill is a member of the BMA Medical Ethics Committee, has been a member of the Medical Research Council’s Stem Cell Steering Committee, is President of the Society for the Study of Christian Ethics and Chairs the British Sociological Association’s Study Group of Religion.

In the current issue of Church Times (Page 19, 26 November 2010) the Editor has published this response from Dr Esther Crawley, SMILE pilot study Chief Investigator to Prof Gill’s letter:

Professor Gill’s article on the SMILE study

From Dr Esther Crawley

Sir, — On 8 October, you published an article about a feasibility randomised controlled trial investigating interventions for CFS/ME in teenagers — the SMILE study. This article appeared two weeks after all study documentation was made publicly available, and we are disappointed that the author, Professor Robin Gill, made no attempt to contact the study team to verify his assertions before publication, particularly given the nature and strength of the assertions made.

We agree with Professor Gill that there is limited evidence on the effectiveness of the Lightning Process in treating CFS/ME. Despite this, approximately 250 children a year pay for and attend Lightning Process interventions. It is precisely for this reason that we listened to children and their families who have asked for improved evidence, and are conducting research that will enable them to make informed decisions about their care.

The SMILE project is not “comparing the effectiveness of the Lightning Process with that of conventional medical care”. Participants in this study will receive either specialist medical care or specialist medical care plus the Lightning Process. The purpose of the study is to assess the feasibility of recruitment to a full trial — it is not designed to compare outcomes of care.

In this article, Professor Gill argues that children or non-competent adults should be involved only when competent and consenting adults have been fully tested first or where this is impossible, and he quotes from the guidance issued by the Medical Research Council (MRC) and the General Medical Council (GMC). There are, however, other quotations he could have selected, such as the MRC’s lengthy advice about when research into medical care for children is important (pages 7-8) and ethical (page 13), and similar statements from the GMC.

Our protocol makes it clear that CFS/ME in children is not sufficiently close to CFS/ME in adults to mean that research in adults could be extrapolated to children. The Royal College of Paediatrics and Child Health states: “Research involving children is important for the benefit of all children and should be supported, encouraged and conducted in an ethical manner.”

Professor Gill ends by stating: “The coercion of children is not an ethically acceptable option.” We absolutely agree with this, and deeply resent the implication that our study involves such coercion. This view was encouraged by the cartoon used to illustrate the article, which we find abhorrent and unacceptable.

All the children and families participating in the SMILE study provide fully informed consent/assent by means of a rigorous, recorded procedure that has been reviewed and given a favourable opinion by a research ethics committee. No child is coerced to join the study, and participants can withdraw at any time.

ESTHER CRAWLEY
on behalf of the SMILE Study Group
School of Social and Community Medicine
University of Bristol
Hampton House
Cotham Hill
Bristol BS6 6JS

The Editor apologises for any offence caused by the cartoon, and for any misrepresentation of the research it might have suggested.

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] 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/

4] Children should not be used as guinea pigs, Church Times, 8 October 2010: http://wp.me/p5foE-3ak

Bath/Bristol Lightning Process pilot study: Minutes of meeting of External Advisory Group 02.11.10

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

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

On 28 October, I submitted a requested for the following information under the FOI Act, from the University of Bristol:

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

2] The SMILE protocol document states on Page 7, under “Study management” that:

The study will be monitored by a Trial Monitoring Group which will meet every 4 to 6 weeks. The trial Monitoring Group will consist of: Dr Esther Crawley (PI), a member of the BRTC as well as applicants on the grant.

An External Advisory Group will also meet: prior to the study starting, by phone conference 6 monthly and at the end of the study. This will be an independent group and will include experts in CFS/ME, including a representative from the Association of Young people with ME (AYME) and the Lightning Process.

Please provide the names of all members of the External Advisory Group and the organisations with which they are associated, where applicable.

 

Today, I have received the following responses from the University’s Information Officer:

That:

Details of collaborators/sponsors are included at sections A63 and A64 of the research ethics application, available online at:

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

from which I conclude that the only patient organisation involved in the planning/development of the SMILE pilot study has been the Association of Young people with ME (AYME).

That:

There was a meeting of the External Advisory Group on 2nd November, the minutes of which are online at:

http://www.bris.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/smileminutesoctober.pdf

That:

The membership of the group is included in these minutes.

 

Text of Minutes, appended, or open on ME agenda site here: SMILE Minutes 02.11.10

Agenda External Advisory Group: November 2nd 5pm – 6pm.

Present:

Stuart Logan (Chair) (SL), Exeter University
Jane Coad (JC), Coventry University
Jenny Ingram (JI), University of Bristol.
Kamal Patel (KP), Paediatrician, Brighton
Alison Wearden (AW), University of Manchester*
Mary-Jane Willows (MJ W), CEO AYME

Also Present: Esther Crawley (PI) (EC)

(*Ed: Dr Alison Wearden was PI for the FINE Trial. No representative of the Lightning Process appears to have been present.)

Everybody introduced themselves. EC outlined the study.

Review of study documentation

SL invited comments on the study documentation. SL said the aims and objectives were clear and it was good to see documentation on the web. This comment was endorsed by other members of the meeting.

1. There was a general discussion about what would happen if either the Lightning Practitioner or the child/family felt that a LP course was not appropriate after discussion. It was agreed that understanding about drop outs was part of the study.

2. There was a discussion that the PIS wasn’t clear on the qualifications or registration of the practitioners. EC agreed and suggested that an amendment was put forward to ethics to add further information on the PIS about this.

[Action] EC to draft amendment for PIS

3. AW asked whether groups would be feasible given the wide geographical area. EC replied that there were concerns about this but that was why a feasibility study was so important.

4. AW asked why the Chalder trial was not included in the reference list. EC replied that it was published after initial submission to Ethics.

5. JC suggested that the teenager PIS was clearer to read then the adult PIS and could be used for both.

Information requests

EC informed the External Advisory Group that it was likely that FOI requests would be received

Minutes

EC suggested that the minutes were put on to the website. This was agreed.

[Action] EC: Minutes to go on web

AOB

1. SL asked how the study was going to date. EC replied that recruitment was going well, parents and teenagers appeared to be enthusiastic and there was a higher recruitment rate then envisioned.

2. EC informed the group that she needed to respond to complaints made to NRES about the study. She suggested that she drafted a response, discussed this with co-applicants and sent the response to the External Advisory Group before submission. This was agreed.*

[Action] EC to draft response for NRES, show co-applicants and then send to External Advisory Group before submission.

Date of Next meeting – due in 6 months time

[Action] EC to doodle date

[Minutes end]

*Ed: See:

Response from Joan Kirkbride, National Research Ethics Service (complaint in response to ethical approval of SMILE Lighting Process pilot study in children), 8 November 2010

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

Progress on complaints to NRES (ethics approval of SMILE Lightning Process pilot study in children), 16 November 2010

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

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] 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/

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.

Which patient organisations were involved in the development of the SMILE pilot study?

Which ME and CFS patient organisations were involved in the development of the SMILE Lightning Process pilot study in children 12 to 18 years?

Shortlink: http://wp.me/p5foE-3c8

In her response to the ME Association, Joan Kirkbride, Head of Operations, NRES, has said:

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. 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.

It is already known from the SMILE Research Protocol document that AYME has a seat on the External Advisory Group. But Ms Kirkbride’s statement suggests that more than one patient organisation may have been involved in the planning and development of this controversial pilot study.

On 24 August, I had written to Sir Peter Spencer (CEO, Action for M.E.) with a query in relation to two published position statements issued by the organisation on the proposed Lightning Process pilot study:

I had asked:

[…]

To date, there is virtually no information in the public domain about the proposed study design and methods and the research protocol is not expected to be published until the end of this month.

a) What is Action for M.E.’s understanding of what will be applied to the children during the life of the pilot study and by whom?

Where has it obtained the information on which it has based its decision to support this pilot study and to support any decision by the ethics committee(s) to grant a “favourable opinion”, ie, to approve the application?

b) Would Action for M.E. please set out what information it has relied upon in order to inform its position on this pilot and whether the organisation has made any approaches to the researchers or to any other body to obtain information about the proposed study over and above the press release, and what was the outcome of any approaches made?

Sir Peter Spencer’s response (24 August):

Our position derives from our detailed reading of the MRC Ethics Guide for medical research involving children and from our understanding of the role of any ethics committee in satisfying itself that appropriate independent arrangements are in place to ensure patient safety.”

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.

We do, of course, want to see research into LP in adults too – but as children are already seeing LP practitioners, before the process has been subject to research published in respected peer-reviewed journals, we can see a case for investigating if it is feasible within the Ethics Guide to set up a controlled trial.

Yesterday, 28 October, I submitted a request for information to the University of Bristol’s Information Rights Office and will update when this request has been fulfilled.  I have asked for:

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.

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 in this post:

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

Response from NRES following complaints about Lightning Process trial

Response from Joan Kirkbride, Head of Operations, NRES, following complaints about Lightning Process pilot study in children

Shortlink: http://wp.me/p5foE-3c2

ME Association  |  28 October 2010

Lightning Process trial and the National Research Ethics Service

The ME Association has written to the National Research Ethics Service (NRES) to ask them to clarify what action they are taking, or may be taking, in relation to concerns that are being expressed about this trial.

We have today received a reply from Joan Kirkbride, Head of Operations at NRES – part of which contains the following generic acknowledgement for correspondence relating to this trial:

“NRES has received the submissions from 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 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. 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.

Joan Kirkbride
Head of Operations, England
National Research Ethics Service (NRES), National Patient Safety Agency
Darlington Primary Care Trust, Dr Piper House
King Street, DARLINGTON, DL3 6JL”

MEA editorial note: REC – in paragraphs two and three of Joan Kirkbride’s letter – stands for Regional Ethics Committee.

 

Ed: Dr Esther Crawley is the Medical Consultant to AYME and AYME has a seat on the pilot study Advisory Group. Action for M.E. had denied any knowledge about the design of the pilot study. Where Ms Kirkbride refers to “the ME charities involved in the development of the study” it is unclear which patient organisations are being referred to.