Letter issued by NRES following scrutiny of complaints in relation to SMILE Lighting Process pilot study

Letter issued by NRES (6 January 2011) following scrutiny of complaints in relation to SMILE Lighting Process pilot study

Shortlink: http://wp.me/p5foE-3g5

Letter issued 06.01.11 by National Research Ethics Service

Open PDF here: 05.01.11 Letter SMILE

 

Received 6 January 2011, by email attachment

Mrs Joan Kirkbride
Head of Operations
National Research Ethics Service
Darlington PCT
Dr Piper House, King Street, Darlington DL3 6JL
Direct Line – Mobile 07979 806425
Tel: 01325 746167 (Assistant – Janet Kelly)
Fax: 01325 746272
Email: joan.kirkbride@nres.npsa.nhs.uk
Website: www.nres.npsa.nhs.uk

Dear Ms Chapman

Assessing the feasibility and acceptability of comparing the Lightning Process with specialist medical care for Chronic Fatigue Syndrome (CFS/ME) – pilot Randomised Controlled Trial

This study, exploring how best we might treat children with Myalgic Enchephalitis [sic] or Chronic Fatigue Syndrome under the guidance of Dr Esther Crawley, Senior Lecturer/Consultant, Child and Adolescent Health sponsored by Bristol university and with the active participation of the association of Young People with ME (AYME) was reviewed on 8 July 2010 by the South West Research Ethics Committee (REC) as part of standard research regulation and ultimately received a favourable opinion on 8 September 2010.

Subsequently the National Research Ethics Service (NRES) received a number of emails and letters about this study and, despite being satisfied with the ethical review, felt it fair to give consideration to the issues raised.

It was clear that the application had received a considered and extensive review of the ethical issues of the project prior to the issue of the favourable opinion. This met all required procedures and processes, however, in view of the weight of correspondence received, much of which raised very similar issues, NRES asked the REC to consider the application, taking into account the issues that had been raised in the subsequent correspondence. Dr Hugh Davies, NRES Ethics Advisor provided a summary to the REC on the issues which had been raised and the opportunity was offered to Dr Crawley and the research sponsor to respond to the issues raised.

In December 2010, the South West REC met again to consider the application and associated documentation. Dr Davies and Mrs Kirkbride attended the meeting to provide advice and support to the REC in relation to ethical matters and operational processes. Dr Crawley was also invited to attend the meeting and was accompanied by sponsor representative Professor David Gunnell. The Chief Executive of the Association of Young People with ME (AYME) had been due to attend to offer support but as a result of illness was unable to do so and sent in a letter of support. The REC considered all the information available to it and discussed the application and agreed a number of questions which they then put to Dr Crawley. After this interview and further consideration the REC agreed that they would uphold their initial decision to grant a favourable opinion to the research with one minor change to the patient information documentation and one suggestion for the future should the research progress beyond a feasibility study.

Given the uncertainties of treatment of this condition and the need to resolve these, in line with professional guidance and duties, the REC felt this project would be a valuable start. A copy of the minutes of the meeting are attached and provide full detail of the discussions and agreements reached. I would like to thank you for your time in raising with NRES your concerns about the study. NRES believes that the initial application received a thorough review and an extensive reconsideration of the application at the December meeting and that it has fulfilled all its duties in the ethical review of the application.

Yours sincerely
JOAN KIRKBRIDE
Head of Operations, England

Encs Minute of the application discussion

National Research Ethics Service, National Patient Safety Agency, 4-8 Maple Street London W1T 5HD
Tel: 020 7927 9898 Fax: 020 7927 9899

Extract of Minutes from South West 2 REC meeting held on 2 December 2010.

5.1   10/H0206/32

Assessing the feasibility and acceptability of comparing the Lightning Process with specialist medical care for Chronic Fatigue Syndrome or Myalgic Encephalopathy (CFS/ME) – pilot Randomized Controlled Trial.

Chief Investigator: Dr Esther Crawley

Type of review: Other

Sponsor: Royal National Hospital for Rheumatic Diseases NHS Foundation Trust

Joan Kirkbride, NRES Head of Operations advised that the REC had previously given this study a favourable opinion to this study. Following this, NRES had dealt with a number of requests under the Freedom of Information Act from people and organisations who had raised a number of objections about the study. In view of this correspondence NRES asked the REC to debate these representations. Her attendance and that of Dr Hugh Davies, NRES Ethics Advisor at today’s meeting was to provide the REC with any guidance they may require in relation to process and ethical considerations.

To facilitate this review, Dr Davies, had put together a paper which included a collection of representations made on this study. The points raised by the representations were distilled into 15 issues that the Committee discussed in turn.

Permission had been sought from people who had sent correspondence to NRES to forward this information to Dr Crawley. Dr Crawley had provided a detailed response, which included letters from Mary-Jane Willows, CEO of Association for Young people with ME (AYME) and Colin Barton, Chairmen [sic] of the Sussex and Kent ME/CFS Society which the REC had available for consideration.

1. The study is misnamed and should be seen as more than a pilot study.

The Committee felt that 96 participants may be quite a lot to recruit for a feasibility study and queried if a 30% drop out rate was expected. In discussion with the researchers the REC were happy with the title of the study

2. Purpose

The Committee reviewed what data was available comparing the effectiveness of different treatments. This data seems to indicate that the Lightning Process is as effective/ineffective as many other current treatments and that more research is needed to resolve these uncertainties for the benefit of ME patients.

3. The Lightning Process (LP) is subject to trading standard and Advertising Standards Authority (ASA) enquiries

Complaints that Mr Parker made unsubstantiated claims of effectiveness have been upheld by the ASA and this is in line with data from the ME society indicating it is effective (or ineffective) or harmful as other therapies. It was noted that the judgement of the ASA was made after the submission of the application to the ethics committee . And corrective action had been taken

4 Mr Parker is shortly to attend court for making false claims about his product

The Committee noted the correspondence submitted by Dr Crawley from Mr Parker and the refutation of this. The Committee considered this but had no further comments to make on this point

5 Conflict of interest

The REC considered this and felt they were similar to much other research and that they were adequately handled in the application

6. Mr Parker has a history of past failed businesses

The Committee noted the correspondence submitted by Dr Crawley from Mr Parker refuting this. The Committee considered this.

7. Mr Parker has used the study to increase sales

No evidence has been provided that Mr Parker has specifically used this study to increase sales. It was noted that the adjudication by the Advertising Standards Authority (ASA) had stated that “The ad [16 June 2010 Internet sponsored search] must not appear again in its current form. We [the ASA] told Withinspiration to ensure they held substantiation before making similar efficacy claims for the lightning process” and that all Lightning Practitioners had been advised of this. The protocol and application clearly state that practitioners had been informed that they must make NO therapeutic claims on the basis of this study.

8. The complainants claim it is not appropriate to research children before work has been conducted in an adult population that can give consent

It was felt that respondents had selectively quoted from guidance about the acceptability to undertake research on children.

The Committee accepted the researcher’s view that CFS/ME is different in children and adults and therefore results from research on adults cannot be extrapolated to children.

9. Risk

The Committee noted that the intervention was in addition to standard care. The ME association survey data seemed to suggest it is as effective, ineffective or harmful as many other current treatments. Evidence of the risk provided to NRES was anecdotal and of low evidential value, reinforcing the need for such a trial as this one.

The Committee felt that there may be a slight risk of a child being worse after therapy (but equally a chance of improvement) and considered that they could withdraw at any time from the study if they wanted to. Supervision of the process was in place

10. Service user involvement

The Committee were reassured by the fact that AYME had been consulted during the planning of this study.

11. The role of the External Advisory group

The Committee considered that AYME has been consulted during the planning of this study.

12. The claims that the LP is coercive and bullying

The Committee considered this but were satisfied by the processes and precautions in place in the study..

13. Concern about the “primary endpoint”

The Committee clarified that this is only a feasibility study and that the primary endpoint is to see if it a full study is possible. The Committee also suggested that the secondary endpoint could be altered to assess the return to the education that children were in prior to their treatment rather than attendance at school.

14. A lack of generalisability

The Committee considered that the researchers accepted that they would not be able to generalise from this to children who had severe ME that kept them at home. It would still provide data on other children with this condition.

15. Participant Information

The Committee was unsure if the ME groups have enough information in the PIS to join.

The Committee felt that the PIS should include statistics on the risks of getting worse, whether there was no change, or whether the treatment was helpful.

The Committee debated whether, in order to address a possible perceived lack of training of those that might be conducting the Lightning therapy that a practitioner who is subject to a professional code of conduct could be used to deliver the therapy. This was also considered in discussion with the researcher.

The Committee also wanted to know if the research has begun recruitment.

Dr Esther Crawley and Professor Gunnell were invited to join the meeting and were asked by the Vice-Chair to clarify the following issues:

Q1: Is there anything you would like to say regarding your study?

Dr Crawley said that this research had the full support of children and families, indeed the impetus for starting it came from children and families and had the support of AYME. They started recruiting in September and this is well up to schedule. Dr Crawley said that it was a feasibility study and the Committee were content with this.

Q2: You stated that the study has started recruiting,

Dr Crawley stated there has been a high recruitment rate so far. Participants have not started receiving treatment yet.

Q3: Please explain your recruitment figures and what dropout rate are you expecting?

Dr Crawley replied that 96 participants may seem high for a feasibility study this number is smaller than that for some other feasibility studies and reflects both the expectation of up to 50% dropout in one of the arms and a moderate treatment effect (participant numbers reflect the need to ensure there is sufficient data to reliably estimate sample size requirements for the full trial) .Therefore they need high numbers to keep the numbers up to judge across the arms and see why people are dropping out.

Q4: Are there differences in the way children and adults are treated?

Dr Crawley replied that the treatment approaches are very different in the two groups. There are lots of points of difference but given the outcome is so different between adults and children, adult services tended to focus on symptom management whilst paediatric services aimed for recovery. In addition, paediatric services involved families and dealt with education not work. She added that children are already receiving this treatment and that we need to evaluate it to see if it works.

Q5: The practitioner of the lightning therapy has no other allied professional qualifications. The Committee suggested that it might be beneficial to the research if the practitioner had external qualifications other than in Lightning therapy and was covered by a code of conduct?

Dr Crawley replied there is a geographical limitation to who can be chosen and that she has worked before with the Bath practitioner who is good. In addition, the children will remain under her care. Prof Gunnell pointed out that children will continue to be under the specialist service in both arms. As the Chief Investigator for the study Dr Crawley accepted responsibility for the activities of the research team and pointed out that in this feasibility study, all Lightning intervention sessions will be recorded and some observed.

The Committee requested that the fact that the practitioner is not clinically qualified be added to the PIS.

The Committee suggested that consideration should be given to using “clinically qualified” Lightning Practitioners should the feasibility study proceed to a full study in the future.

Q6: The risk balance of the study is not included in the PIS.

Dr Crawley and Professor Gunnell replied that they would be happy to add this to the PIS. They added that according to the figures in the Parliamentary Inquiry into NHS Service provision for ME/CFS*, Lightning therapy fares better than the standard NHS therapies of Graded Exercise Therapy (GET) and Cognitive Behavioural Therapy (CBT).

It was noted that this information related to treatment in adults. Data for children was not available. They also added that when patients get better they also don‟t tend to take part in surveys.

The Committee asked for these figures to be added to the PIS and to reference them so they are available but to note that they are relative to adults.

Q7: The Committee discussed the secondary endpoint regarding returning to school and suggested that it could be altered to assess the return to the education that they were in prior to their treatment rather than attendance at school.

Dr Crawley replied that recruitment and retention is the primary endpoint of the study as it is a feasibility study. She added that the inventory used to measure school attendance also measures home tuition. Those children that are house bound are excluded from the study as they have to be able to get to the clinic.

Dr Esther Crawley and Professor Gunnell left the meeting.

The committee felt that given current treatment uncertainty research was vital in this area and the proposal is a standard way to assess this. Currently survey data were limited and it was unwise to base health policy on individual case reports. It is vital to see if the lightening process is or is not helpful as children are already receiving this therapy.

The committee voted unanimously to confirm the favourable opinion of the application with the following additional conditions:

1. PIS for Teenagers and PIS for Parents: Please add the fact that the Lightning Practitioner is not clinically (medically) qualified (trained).

2. PIS for Teenagers and PIS for Parents: Please include the following text in the “Are there any disadvantages to taking part” section:

“Teenagers with CFS/ME can get worse with any intervention offered. There is no data in teenagers, see tables 1 and 2 for data in adults.”

3. PIS for Teenagers and PIS for Parents: Add the figures for GET, CBT and the LP from the Parliamentary Inquiry into NHS Service provision for ME/CFS include Data taken from Action for ME (AfME) and Association of Young people with ME (AYME) joint report “M.E. 2008: What progress” and reference it.

4. PIS for Teenagers and PIS for Parents: Add the figures for GET, CBT and the LP from the 2008 MEA survey and reference this.

The Committee suggested that for the future Dr Crawley might consider using Lightening [sic] Practitioners who were additionally clinically qualified.

Decision

The Committee restated the favourable opinion of the application.

The Committee nominated Tom Lucas to be the point of contact should further clarification be sought from the applicant.

[Ends]

*Ed: Note: The Inquiry into NHS Service provision for ME/CFS was not a “Parliamentary Inquiry”.  This was an unofficial inquiry instigated and undertaken by the APPG on ME. The interim report published by the APPG on ME, last year, does not have the authority of either House nor any government agency or department.

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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/

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/

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/

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

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

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

Related information:

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

On 3 November, I submitted a complaint to Joan Kirkbride, Head of Operations, England, National Research Ethics Service (NRES), in response to the decision of a South West Region Ethics Committee to grant ethics approval to the SMILE pilot study.

A response was issued by Ms Kirkbride on 8 November, which can be read at the link above.

Today, I have asked Ms Kirkbride:

I am not familiar with the Standard Operating Procedures that NRES works within when dealing with complaints from members of the public in relation to the handing down of favourable opinions following applications to regional ECs or what kind of timeframe scrutiny of, or investigation into complaints might be conducted within.

Can members of the public expect to receive any form of notification as to the progress or outcome of your colleagues’ consideration of the concerns you have received and following the gathering of responses from the various parties cited below?*

*The “Standard Response” being issued by Ms Kirkbride on behalf of the NRES had stated that it was felt that a fair way forward would be initially “to seek the responses of the researchers, sponsor and the ME charities involved in the development of the study”.

I am advised by Ms Kirkbride that NRES are collating a list of all the people/organisations who have contacted them about this study; that they have received considerable correspondence about this matter which will take them some time to consider and take forward but that it is their intention to advise everyone who has written to them about the process and the outcome.

So, an open-ended process with no clear procedural timeline.

Related material:

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

2] ASA adjudication against “Withinspiration”, June 2010

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

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

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.

Lightning Process pilot study in children (SMILE): request for the funding application documents

Lightning Process pilot study in children (SMILE): request for the funding application documents

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

Dr Esther Crawley’s research team had secured funding for the controversial Lightning Process pilot study using children as young as 12 from the Linbury Trust and the Ashden Trust, last November. The study received ethics approval this September.

The breakdown for the funding is (from FOI request, 16 May 2010)

a) Value of grant awarded by the Linbury Trust: £120,000
b) Value of grant awarded by the Ashden Trust: £44,000
c) Any other sources of funding for the pilot study: No other funding sources

The Linbury Trust has funded a number of “CFS” studies in the past, including some previous studies by Dr Crawley’s research team.

But the Ashden Trust doesn’t appear to have a history of funding health/medical research. Both trusts are funding arms of the Sainsbury family.

http://www.ashdentrust.org.uk/

http://www.ashdentrust.org.uk/aboutus.html

“The trust’s long-term focus on climate change, sustainable development and improving the quality of life in poorer communities allows us to explore a range of ways to tackle these enormous challenges under six category headings:

•Sustainable Development International
•Sustainable Development UK
•Sustainable Regeneration
•People at Risk
•Arts and Sustainability
•Social Investment Fund”

 

On Monday, I requested the following documents from the University of Bristol’s FOI office, since this material had not been included with the 29 documents published by the University, on 16 September, at:

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

so that part of my original FOI request, in May, remained unfulfilled:

1] Copies of the funding application documents submitted to

a) The Linbury Trust

b) The Ashden Trust

including any accompanying documentation that formed part of the applications for funding.

2] Copies of all correspondence associated with the applications for funding.

 

The response has been that there was  no “funding application”, as such; that the study protocol had been submitted to the funders and, in effect, was the funding application.

I have been provided with copies of three letters from the Linbury Trust and Ashden Trust in relation to the funding application (that had previously been disclosed under FOI in response to requests made by others) which I have already posted on this site.

I am advised that there is a typo in the Linbury Trust letter of 8 March 2010 and that the “£120,000” in the opening paragraph should have read “£44,000”.

I am further advised that there is a handwritten note on the Linbury Trust letter of 4 November 2009, stating that a confirmation email was sent on 5/11/09 and that this email from Dr Crawley had read:

“Thank you for your letter informing me that the trustees of the Linbury Trust have agreed to make a grant to support the project: Assessing the feasibility and acceptability of comparing the Lightning Process with specialist medical care for CFS/ME.

“I am delighted that we will be able to do this piece of work and I am very grateful to the Linbury Trust for supporting this work.

“I will be in touch shortly when I know more about who organises the contracts. When the contract is organised, I can start recruiting personnel for the study.”

“Thank you once again.”

 

These are the documents I have been provided with:

Document 1:

4 November 2009  |  Linbury Trust to Dr Esther Crawley  |  Open PDF:  Funding Linbury Trust 04.11.09

Note: The grant is conditional on the project commencing no later than October 2010.

Document 2:

24 November 2009  |  Ashden Trust to Dr Esther Crawley 

Document 3:

8 March 2010  |  Linbury Trust to Dr Esther Crawley

 

The research application had been reviewed by South West 2 REC at a meeting of the committee on 8 July.  Following the meeting, the committee had requested that the applicants make a number of amendments to the text of patient information sheets (PIS) and other documentation. Confirmation of approval of the revisions to the application was given in September.

Since this is all the information relating to the application for funding that has been made available to me, it remains unclear why the Linbury Trust was not in a position to award the full £164,000 for the project and why £44,000 has been provided by the Ashden Trust for a medical research study in children – a field which appears to lie outside the Trust’s usual areas of funding, which are listed on its website as “climate change, sustainable development and improving the quality of life in poorer communities”.

Other than a protocol document, it is unclear how much information about the Lightning Process and how it is carried out was available to the funders in order that they might make informed decisions about whether to fund this study.

 

The SMILE Protocol document (Final July 2010) [pdf (170kb)] can be read here:

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

Open here: smprotv6final

 

Correspondence with Ethics Committee can be read here:

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

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

Open here: covlet20may10

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

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

Open here: let14jun

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

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

Open here: let19july

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

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

Open here: letrep28july

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

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

Open here: let13aug

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

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

Open here: letmetn19aug

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

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

Open here: seclet20aug10

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

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

Open here: let13sep

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

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

Open here: applet14sep10

29] REC Form [pdf (353kb)]

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

Open here: recfrmrfs

 

All other published SMILE documents including Patient Information Sheets, Consent forms and Assessment Form, can be read from this post:

SMILE – Specialist Medical Intervention and Lightning Evaluation documents