“CFS orphaned in the “R” codes in US ICD-10-CM” and “Erasing the interface between psychiatry and medicine” (DSM-5)

Two new posts on Dx Revision Watch

Shortlink: http://wp.me/p5foE-3h3

“CFS orphaned in the “R” codes in US specific ICD-10-CM”

http://wp.me/pKrrB-V4

and

“Erasing the interface between psychiatry and medicine” (DSM-5)

http://wp.me/pKrrB-Vn

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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.

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

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

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/

Transcript: BBC Radio Berkshire, Anne Diamond, ME/CFS: Shepherd, Findley, Parker

Transcript of BBC Radio Berkshire Anne Diamond Show, broadcast 11 November 2010

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

On 11 November, Radio Berkshire presenter, Anne Diamond, interviewed Dr Charles Shepherd, Medical Adviser for the ME Association and Professor Leslie Findley, Clinical Director of the National ME Centre and Centre for Fatigue Syndromes. Towards the end of the item, Duncan McLarty spoke to Phil Parker, founder of the Lightning Process.

See also previous post: http://wp.me/p5foE-3dk

Within the UK, until 18 November, you can “Listen again” to the Radio Berkshire broadcast here on BBC iPlayer. The item starts 2 hours 3 mins in from the start of programme and is around 12 minutes long.

Or listen on YouTube here: http://www.youtube.com/watch?v=9YX3wFkDlhI

This transcript has been prepared by Suzy Chapman for ME agenda. Care has been taken in the preparation and proofreading of this transcript; some errors and omissions may remain.

The Anne Diamond Show, Thursday, 11 November 2010:

Anne Diamond: Last week on the show while Esther Rantzen was standing in, we looked at the subject of ME because people diagnosed with the condition are no longer able to give blood. Now we’ve had a huge response from people with experience of the condition and because this is such a controversial area we thought it might be a good idea to get some experts on to the show to deal with some of the points that have been raised.

Dr Charles Shepherd is Medical Adviser to the ME Association and Professor Leslie Findley is Clinical Director of the National ME Centre and the Centre for Fatigue Syndromes. I spoke to them both, earlier, and I asked Charles Shepherd just what is ME and are we any closer to knowing what causes it?

Dr Charles Shepherd: Well ME stands for “Myalgic Encephalomyelitis” and in very simple terms it’s an illness which often starts with a viral infection and people then have a range of symptoms, primarily muscle symptoms, muscle fatigue and also brain symptoms, problems with memory, concentration, balance, just generally feeling unwell. And these systems – I mean these symptoms – persist for a long period of time in many of these patients; it is a very disabling and has been recognised as a neurological illness.

Anne Diamond: Yes. Professor Findley, to be absolutely clear, nowadays there’s no longer any suggestion that it’s a psychological condition, is there?

Prof Findley: Erm, no, there’s no suggestion it’s a psychological condition but psychological factors can adversely influence the symptoms and they have to be taken into account when one’s planning a total management strategy for an individual patient.

Anne Diamond: Would you agree with that, Dr Shepherd, that nowadays we don’t look upon it as a psychological condition?

Dr Charles Shepherd: Well, I thoroughly agree, you know, the Department of Health, the World Health Organisation, classifies this as a neurological illness and you know, like with many chronic disabling illnesses, psychological factors, social factors, can sometimes play a role, that’s not disputed. But it is essentially a neurological illness with other factors involved.

Anne Diamond: Now you see, since Esther was talking about this last week we’ve had an email, for instance, which says that all the research and treatment funding then has inappropriately gone to the psychiatric profession since the 1980s. What do you say to that, both of you?

Dr Charles Shepherd: Well, to a certain extent well that is true. Certainly in the UK, the vast amount of government funded research has gone in to behavioural and psychological therapies and there has been a great deal of criticism about that. Fortunately, what we now have is the Medical Research Council [MRC] setting up an expert group which I am a member of, to look into research in this illness and we have been for the past two years looking at what needs to be done in the way of biomedical research and a list of priorities in biomedical research has now been sent to the board of the MRC – they are looking at these priorities and we are expecting an announcement very shortly on this.

Anne Diamond: Professor Findley, is it true then that we’ve been wasting money – directing the money towards the psychiatric profession?

Professor Findley: We….ell! Waste is a very, is a very strong word to use. The money, I agree with Charles, could have been used perhaps more wisely, but this is a complex illness and it represents, and the MRC would state this, that it represents a group of disorders, it is not a single entity and we’re still having great trouble defining within this large group of patients the individual types of Chronic Fatigue Syndrome/ME that exist and if one takes a group of patients the symptom complex that the individuals complain of vary enormously…

Anne Diamond: And yet…?

Professor Findley: …and the NICE Guidelines recognise complex and severe Chronic Fatigue Syndrome/ME to emphasise the complexity of this, this, this illness, it is not a simple entity it’s not like some tuberculosis where you have a defined marker and a defined organism and a defined treatment.

Anne Diamond: So and Dr Shepherd, you would agree that this a range of different conditions?

Dr Charles Shepherd: Yes, and I mean this is another key point, that we have renamed and redefined this illness from ME into what’s now called “Chronic Fatigue Syndrome”, the term that the medical profession tends to use and unfortunately this has now produced, it’s rather like dumping everyone with different types of arthritis, inflammatory arthritis, osteoarthritis, infective arthritis, under one umbrella and saying that they’ve all got the same cause, the same symptoms and the same treatments and that does not apply to arthritis, it does not apply to everyone who comes under this umbrella of Chronic Fatigue/Chronic Fatigue Syndrome.

This is one of the key points the MRC is addressing the need for sub grouping people under this umbrella, finding the different causative factors that are going on and then applying appropriate different forms of management to the different types of sub groups under this umbrella.

Anne Diamond: Now, I mean, you look at the situation – for instance here in Berkshire – where our Primary Care Trusts [PCTs] are offering Cognitive Behavioural Therapy [CBT]. Is that appropriate any longer?

Dr Charles Shepherd: It’s not appropriate as a one size fits all treatment and this is our big problem with the NICE Guideline, it’s why patients object to the NICE Guideline because the NICE Guideline recommends CBT and Graded Exercise Therapy [GET] should be offered to everyone with mild to moderate ME and this is not what we feel is appropriate one size fits all treatment. Many patients find these therapies either ineffective, around about 50% with CBT and in the case of Graded Exercise treatment, if you apply this wrongly you make these patients worse. That’s why there is terrific concern and anger amongst the patient community with the NICE Guideline.

Anne Diamond: Can I move on to the…this business of the Lightning Therapy, the Lightning Process? Because it was very controversial when Esther was talking about it last week. Her daughter went through it, but some listeners were angry that we even mentioned the Lightning Process. Why is it so controversial? Professor Findley, first…

Professor Findley: Erm, that’s a very straightforward question with a very complex answer. I think the Lightning Process has a part to play in the management of some patients. It is not a specific treatment for Chronic Fatigue Syndrome/ME, it’s used to treat a whole raft of conditions. But there are some patients that can be recognised who have factors which would lend themselves – factors which are perpetuating the illness – which would lend themselves to the Lightning Process.

Now these are, in my opinion, a very small group of patients overall, but because Lightning Process practitioners are often only experienced in that one technique they apply it to anybody who visits them with an objective of getting treatment, so their patients are treated in an unselected manner and therefore this has led to all sorts of complications and dissatisfaction.

Anne Diamond: Dr Shepherd?

Dr Charles Shepherd: Well, I have this strong objection to the Lightning Process – in particular the way it’s marketed to very vulnerable groups of people with adverts which are making unsubstantiated claims about success rates.

Professor Findley: Agreed…agreed.

Anne Diamond: But it clearly is true for some and as you both seem to be agreeing that this is multi-factorial, very complex, no one patient is exactly the same as the other.

Professor Findley: Well I think I absolutely agree with this, but erm… the…and I agree with Charles’ comments on the Lightning Process – it’s been badly, badly applied, poorly researched and we would use it or recommend it probably in perhaps one in thirty or one in forty of patients, after they have been properly assessed over a long period of time and more standard management programmes have been applied.

Anne Diamond: Before we run out of time, can I finally ask both of you really ‘cos a lot of people who contacted us were asking about recovery rates from ME. What can you tell us about the numbers and are indeed there any robust figures on this? Dr Shepherd, first.

Dr Charles Shepherd: Well, I wouldn’t say there were really robust figures. I think its, a lot of it is clinical judgement from individuals, you know, that see patients with this and you know, a limited amount of epidemiological research.

Where I come in is I think we probably have three groups. We have a group at one end of the spectrum who are severely effected certainly at some stage in their illness and they probably account for about 25% of the total, I mean these are people who are bed-bound, wheelchair-bound, house-bound.

We have a large group in the middle who make some degree of, I think the word here is improvement, over the course of time but do not recover but they hit a glass ceiling, 50, 60, 70% of what they were normally like and then we have a small group at the other end of the spectrum who make a much more significant degree of improvement or may even finally recover – an example there is Yvette Cooper, a former government minister. I would add that the improvement/prognosis in children/adolescents with this disease does seem to be a lot better than it is in adults.

Anne Diamond: And Professor Findley?

Professor Findley: I would, there aren’t robust figures and I think Charles is right, we would normally say that the average duration taken across the group, the average duration of this type of illness is three to five years with at least 40% of patients never getting back to previous levels of functioning and I’d agree with Charles there is the very severe group and their prognosis is appalling and they very rarely get any proper management advice.

Anne Diamond: Well that was Dr Charles Shepherd and Professor Leslie Findley speaking to me a little earlier on. It’s a very important subject isn’t it?

It’s very important that we hear a balanced argument on it. So we put some of those issues to the founder of the Lightning Process, Phil Parker. Phil’s website calls the process “A non medical tool that is tailored to help people who are stuck in their life or health”. Well BBC Radio Berkshire’s Duncan McLarty, first asked him whether he agreed that the process is only appropriate in a small fraction of ME cases.

Phil Parker: You know that sounds like scientific data but it’s not science – there’s no evidence to say that, that’s just their opinion! First thing we do is have a chat with people and we assess them as to whether this is a really useful thing for them because obviously we want to see people who we think are going to get value from this.

Duncan McLarty: But if you’re not an ME specialist how would you know if it’s appropriate?

Phil Parker: Er, well we are specialists at the Lightning Process. We know more about the Lightning Process than these people because we designed it and trained in it. So what we are looking for is, do we think these people are likely to get benefit from the stuff that we do. What we’re really interested in is how can we help these people who, who’ve got stuck, where there aren’t many solutions, is there anything we can do to help them that’s really where we’re coming from.

Anne Diamond: Well can I just say thank you very much for all your emails on the subject of ME over the last week or so. I think we’ve certainly shown that it’s a complex area with plenty of strong and sometimes conflicting views. We also asked Phil Parker whether he agreed that the process was aggressively marketed as those two experts told me.

Phil Parker: Basically our practitioners, erm, don’t make claims. What they say is, that you know our experience is, that when some people use this they can make changes. That doesn’t guarantee change. If you…you know you have a business then you want to tell people about it that doesn’t make it aggressive marketing, that’s the thing I… deny and say that all we’re doing is, say look this is something that we’ve found is very useful, have a look at it and if you want to talk to us more about it then do, if you don’t that’s fine as well. We really don’t market it aggressively at all.

Anne Diamond: Well there you are, you see, that was Phil Parker, who is the founder of the Lightning Process, and earlier on I was talking to Dr Charles Shepherd, Medical Adviser to the ME Association, and Professor Leslie Findley who’s Clinical Director of the National ME Centre and the Centre for Fatigue Syndromes.

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/

Dr Charles Shepherd, Prof Leslie Findley and Phil Parker (Lightning Process) on Radio Berkshire

Dr Charles Shepherd, Prof Leslie Findley and Phil Parker (Lightning Process) on Radio Berkshire

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

Note: This is an edited version of content first posted on 11 November.

On 2 November, the ME Association reported that BBC Radio Berkshire had broadcast an interview with the ME Association’s medical adviser, Dr Charles Shepherd, during an item on the UK life ban on blood donation by everyone with the illness ME and CFS which was implemented on 1 November.

During the interview, also broadcast on 1 November, Esther Rantzen, standing in for Anne Diamond, the usual presenter of this mid-morning programme, had sidelined discussion of the implementation of the blood ban to promote the Lightning Process.

The ME Association reported that “Claims were made about the value of Lightning Process approach for people with ME/CFS and recovery rates for the illness which we challenged as soon as we heard they had been made. These will be the subject of a further item on BBC Radio Berkshire on Thursday 11 November…” See next posting

The 1 November broadcast can be heard here, on YouTube, in three parts:

http://www.youtube.com/watch?v=G4MFSRPMOWQ

http://www.youtube.com/watch?v=CS0kHH8NZ0k

http://www.youtube.com/watch?v=vNSgmuMlgXk

There has been considerable concern about the way in which Ms Rantzen conducted herself during the ME strand on this programme which had included contributions from ME patients via phone link. Complaints have been pouring in to the programme producers by email and phone.

One poster on Facebook wrote:

Esther Rantzen to radio caller Will: “..Now I am going to tell you something Will….. I can tell you about my daughter, she found something called the Lightning Process and you can find it on the internet….. it’s a method of training your brain to withstand the symptoms….. it’s a form of Neuro-linguistic Programming, you know how people use their mindset to withstand symptoms….”

Esther to Will: “…Let me tell you something else, it is an illness that most people recover from spontaneously, most people, 60% of people, get back to normality”

(Surely recovery rates are between 5 and 12%?)

Caller Will to Esther referring to the lifetime ban on giving blood by everyone diagnosed with ME (whether or not any improvement in their health has occurred). Will explains that some people have been wrongly diagnosed with ME and turned out to have completely different diseases:

Will: “…The difficulty is with the diagnostic process with ME, it’s an educated guess by specialists so there may be many people diagnosed with ME that may not even have ME in the first place….. now, in line with the blood ban that’s been announced to day what happens if you’ve been misdiagnosed, or undiagnosed…”

Esther: “Well, I mean, obviously the ban cannot apply…”

WRONG. The lifetime blood ban from the 1st November applies to everyone who has been given a diagnosis of ME or CFS in the UK. Esther announced that the ban “cannot apply” to individual cases. That is very irresponsible of her and appears to overrule the Blood Services announcement on the ban.

Esther to Will: “Will listen, don’t give up hope..… I tell you what, have a look at what the Lightning Process, it’s on the internet…”

Esther has directed the caller to look up Lightning on the internet for the second time in a few minutes. What Will would find on the internet is the commercial Lightning site advertising Lightning.

Will: “…I don’t think I have the funds….”

Esther: “I think there may be an equivalent on the NHS”

WRONG. There is no equivalent of Lightning on the NHS.

 

Today, just after 12 noon, in a pre-recorded interview, Anne Diamond discussed ME and CFS in general, its WHO neurological classification, the need for biomedical research and sub-grouping, the MRC’s CFS/ME Expert Group, the Lightning Process, and illness prognosis with Dr Charles Shepherd and Professor Leslie Findley. There was a brief contribution from Phil Parker towards the end of the interviews.

In 2007, Prof Leslie Findley had undertaken an informal, non RCT pilot study of the Lightning Process. No results from this pilot have been published but Prof Findley spoke to the Canadian media in an article here, in 2008, in which he quotes unremarkable results and reports that in small number of cases there can be bad relapses.

CBS News In Depth: Health
Lightning Process
Controversial training program comes to Canada
April 18, 2008  |  By Zoe Cormier

 

Prof Findley had also given a presentation around the pilot study at the 2007 Ramsay Society Annual Meeting with a colleague,  Gerrie de Vries. There is no English summary or note of this Ramsay Society meeting but photographs and notes were published, in German, by Regina Clos, which can be read in auto translate here:

Gerrie de Vries & Leslie J. Findley: “The Effects of the Lightning Process in the Management of Chronic Fatigue Syndrome – a start.” : http://tinyurl.com/sykesgermantoenglish

An personal account here on Bad Science Forum mentions Prof Findley’s involvement in “Neuro Behavioural Training” – an approach described as encompassing “Occupational Therapy, Clincal Hypnotherapy, Neuro Linguistic Programming, Cognitive Behaviour Therapy and Life Coaching”. Sessions take place over three days.

When asked about the Lightning Process, in today’s interview, Prof Findley said “…it’s been badly, badly applied, poorly researched and we would use it or recommend it probably in perhaps one in thirty or one in forty of patients, after they have been properly assessed over a long period of time and more standard management programmes have been applied” but he did not mention that he had, himself, undertaken an informal pilot in 2007.

 

Until 18 November, you can “Listen again” to the Radio Berkshire broadcast on BBC iPlayer at:

Radio Berkshire 11 November Anne Diamond

Starts at 2 hours 3 mins in from beginning of programme.

Broadcast on BBC Berkshire, 10:00am Thu, 11 Nov 2010
Available until 1:02pm Thu, 18 Nov 2010

Or listen on YouTube, here:

http://www.youtube.com/watch?v=9YX3wFkDlhI

On 10 November I sent this letter of complaint to the producers of the Anne Diamond programme. (At 18 November, I have yet to receive a response or acknowledgement.)

Re: Broadcast in which Esther Rantzen discussed ME/CFS and the new UK ban on blood donation by everyone with the illness with ME Association medical adviser, Dr Charles Shepherd, BBC Radio Berkshire: Monday 1 November

I am writing to complain about Ms Rantzen’s handling of this broadcast.

I understand that Ms Rantzen was standing in for the usual presenter, Ms Anne Diamond.

I have the following concerns:

1] Ms Rantzen was brought in to present a programme during which the ME/CFS blood ban would be discussed.

Ms Rantzen has a number of COIs in relation to ME/CFS.

Ms Rantzen is President of AYME (The Young People’s ME Trust).

She is known to promote the Phil Parker Lightning Process in the media.

The patient organisation of which she is President has for its medical adviser, Dr Esther Crawley.

Dr Esther Crawley is about to commence recruiting participants to a controversial pilot study where the Lightning Process will be applied to children aged 12 to 18 years old, for which Dr Crawley is Chief Investigator.

The patient organisation of which Ms Rantzen is President has been involved in the development and planning of this Lightning Process pilot study.

The patient organisation of which Ms Rantzen is President has a seat on the “Expert Advisory Group” for this Lightning Process pilot study.

2] I have scrutinised a partial transcript and note that during the broadcast, Ms Rantzen, on several occasions, sought to promote the Lightning Process to the public and to a contributor to the programme calling on a phone-link and that she also directed him to look at the internet for more information on the Lightning Process.

Ms Rantzen also made claims for recovery rates of patients with ME/CFS for which she offered no supporting evidence.

3] In my opinion, Ms Rantzen gave misleading information in relation to the blood ban and its application to individuals.

In response to the caller’s concerns about the cost of the Lightning Process, Ms Rantzen is reported as having said, “I think there may be an equivalent on the NHS”.

This is incorrect, there is no equivalent available on the NHS.

In the light of Ms Rantzen’s COIs and given her blatant promotion of the Lightning Process during a BBC broadcast I do not consider that Ms Rantzen could be considered to have been a neutral presenter.

I do not consider that she should have used the issue of the ME/CFS blood ban to promote a commercial “training” programme marketed by Phil Parker and his Lightning Process trainers / coaches / practitioners during a BBC broadcast.

I consider that the BBC was negligent in its failure to take Ms Rantzen’s COIs into consideration when selecting a stand-in for Ms Diamond and that Ms Rantzen had taken advantage of her position, as presenter, to introduce and promote the Lightning Process to the public during an item, the focus of which, was the recent UK blood ban for ME/CFS patients.

I would welcome your responses.

I also request a copy of the BBC’s policy on the declaration of COIs in its presenters and a copy of the BBC’s policy on the promotion of commercial goods and services by BBC presenters during broadcasts.

Sincerely, etc

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