Snow Leopard
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Do they think that LP is CBT rebranded or something!?!
Lightning Process to be Evaluated in Research Study on Children
- Thread starter Jenny
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Do they think that LP is CBT rebranded or something!?!
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Originally Posted by ME agenda
"What on earth are GOSH and Barts doing giving LP a platform?"
Snow Leopard asked: "Do they think that LP is CBT rebranded or something!?!"
In a word - Yes.
(old govenment) Health Minister Mike O’Brien, APPG meeting 2nd December 2009:
“I don’t want to get into a detailed argument about the lightning process, which I do know a fair amount about. I would say that it seems to be a way in which CBT can be used to help people deal with a long-term condition that would otherwise be more debilitating than it is..”.
The idea appears to be to keep CBT/GET as official ‘CFS’ ‘treatment/management’ but with additional ‘therapies’ bolted on. The only ‘other therapy’ that has been seriously discussed as possible addition to the existing official ‘CFS’ treatments is Lightning.
A section (below) from the Transcript of the All Party Parliamentary Group on ME Meeting of 2nd December 2009 in which the Health Minister of the time (Mike O’Brien) talks about Lightning. Although the Minister claimed he knew quite a lot about it, its clear from his statements that he didn’t have the foggiest clue about what Lightning is or what Phil Parker and the Lightning Trainers do and claim. The Minister thought LP is a form of CBT to help with ‘the psychological’ etc. Its not. Even Phil Parker says LP not a form of CBT.
This Lightning Trainer spells out what Lightning is claimed to do:
http://www.light-at-the-end-of-the-tunnel.co.uk/lp_facts_neg_opinions.html
“…the Lightning Process finds
That M.E is totally recoverable from
That over 90% of participants gain recovery from their M.E..”
At this December 2009 APPG meeting an interim Report of the APPG Group NHS Services Inquiry was presented (the full Report was published later in 2010). At the oral evidence sessions for the Inquiry only three patients were selected by the Inquiry committee to give oral evidence. One of the three spent the whole of their oral evidence praising Lightning.
The three patients who gave oral evidence had been selected from the greater number who had sent in written evidence to the Inquiry, in other words the Committee knew the kind of thing the patients selected to give oral evidence were going to say. It could be concluded that the APPG Inquiry Committee had decided to include Lightning as a subject worthy of positive attention by the APPG NHS Services Inquiry. There was no opportunity for any balancing presentation to present the problems with Lightning.
A section From the APPG 2nd December Transcript (Janice Kent is founder and Secretary of Sussex CFS Charity reMEmber.
Mike OBrien was the Health Minister of the time):
Janice Kent: “Thank you Des, I have two quick points. You mentioned the lightning process. The Sussex service has been giving out cards so that patients can go to a lightning process practitioner. It costs 560. Dr. Mike Broughton, the clinical lead of the Sussex service, held a “Meet the doctor” session at the Chalky Road surgery a couple of weeks ago. He was questioned about the lightning process and—surprise, surprise—it seems only to work for those patients who are not ill……” …….
Mike O’Brien: Well, you rest it badly, sadly, because I am a patient of the NHS at the moment as it happens, and so is another Minister. There are a number of Ministers who happen to be patients too. If you look at every Minister in the Department of Health, they will at some stage have been a patient of the NHS. We spend a lot of time consulting with people who are currently patients and have to deal with a lot of different conditions.
I am aware that there is a lot of controversy around the lightning process. Some people feel that it is absolutely useless, and others think it is wonderful and a process that can help them to recover.
Janice Kent: If they’re not ill.
Mike O’Brien: Well, that is your view.
Janice Kent: That is Dr. Mike Broughton’s view.
Mike O’Brien: Well, I don’t happen to share it. It is a matter of controversy among people with ME. Clearly, it is not working for some, but it does appear to help others. Because it is basically about the way that people deal with a long-term condition, it might assist them in dealing with that condition. However, it is probably not a cure in itself—no one is arguing that.
Janice Kent: That is how it is presented.
Mike O’Brien: I don’t want to get into a detailed argument about the lightning process, which I do know a fair amount about. I would say that it seems to be a way in which CBT can be used to help people deal with a long-term condition that would otherwise be more debilitating than it is. Is it a cure? That depends on the extent to which you regard ME as a physical rather than a psychological condition. If people are ill for a long period with a physical condition, they’re also psychologically affected. My basic view about CBT and the lightning process in particular is that it can help people who have long-term illnesses, but that does not necessarily mean that it is the cure for anything. If the illness is caused by physical issues, a psychological response might help the individual to deal with it, but not cure them...
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
But the Minister Mike O’Brien was wrong.
THIS is what Lightning Trainers claim Lightning does, not help with living with ME, but recovery from ME with Lightning:
http://www.light-at-the-end-of-the-tunnel.co.uk/lp_facts_neg_opinions.html
“…the Lightning Process finds
That M.E is totally recoverable from
That over 90% of participants gain recovery from their M.E..”
"What on earth are GOSH and Barts doing giving LP a platform?"
Snow Leopard asked: "Do they think that LP is CBT rebranded or something!?!"
In a word - Yes.
(old govenment) Health Minister Mike O’Brien, APPG meeting 2nd December 2009:
“I don’t want to get into a detailed argument about the lightning process, which I do know a fair amount about. I would say that it seems to be a way in which CBT can be used to help people deal with a long-term condition that would otherwise be more debilitating than it is..”.
The idea appears to be to keep CBT/GET as official ‘CFS’ ‘treatment/management’ but with additional ‘therapies’ bolted on. The only ‘other therapy’ that has been seriously discussed as possible addition to the existing official ‘CFS’ treatments is Lightning.
A section (below) from the Transcript of the All Party Parliamentary Group on ME Meeting of 2nd December 2009 in which the Health Minister of the time (Mike O’Brien) talks about Lightning. Although the Minister claimed he knew quite a lot about it, its clear from his statements that he didn’t have the foggiest clue about what Lightning is or what Phil Parker and the Lightning Trainers do and claim. The Minister thought LP is a form of CBT to help with ‘the psychological’ etc. Its not. Even Phil Parker says LP not a form of CBT.
This Lightning Trainer spells out what Lightning is claimed to do:
http://www.light-at-the-end-of-the-tunnel.co.uk/lp_facts_neg_opinions.html
“…the Lightning Process finds
That M.E is totally recoverable from
That over 90% of participants gain recovery from their M.E..”
At this December 2009 APPG meeting an interim Report of the APPG Group NHS Services Inquiry was presented (the full Report was published later in 2010). At the oral evidence sessions for the Inquiry only three patients were selected by the Inquiry committee to give oral evidence. One of the three spent the whole of their oral evidence praising Lightning.
The three patients who gave oral evidence had been selected from the greater number who had sent in written evidence to the Inquiry, in other words the Committee knew the kind of thing the patients selected to give oral evidence were going to say. It could be concluded that the APPG Inquiry Committee had decided to include Lightning as a subject worthy of positive attention by the APPG NHS Services Inquiry. There was no opportunity for any balancing presentation to present the problems with Lightning.
A section From the APPG 2nd December Transcript (Janice Kent is founder and Secretary of Sussex CFS Charity reMEmber.
Mike OBrien was the Health Minister of the time):
Janice Kent: “Thank you Des, I have two quick points. You mentioned the lightning process. The Sussex service has been giving out cards so that patients can go to a lightning process practitioner. It costs 560. Dr. Mike Broughton, the clinical lead of the Sussex service, held a “Meet the doctor” session at the Chalky Road surgery a couple of weeks ago. He was questioned about the lightning process and—surprise, surprise—it seems only to work for those patients who are not ill……” …….
Mike O’Brien: Well, you rest it badly, sadly, because I am a patient of the NHS at the moment as it happens, and so is another Minister. There are a number of Ministers who happen to be patients too. If you look at every Minister in the Department of Health, they will at some stage have been a patient of the NHS. We spend a lot of time consulting with people who are currently patients and have to deal with a lot of different conditions.
I am aware that there is a lot of controversy around the lightning process. Some people feel that it is absolutely useless, and others think it is wonderful and a process that can help them to recover.
Janice Kent: If they’re not ill.
Mike O’Brien: Well, that is your view.
Janice Kent: That is Dr. Mike Broughton’s view.
Mike O’Brien: Well, I don’t happen to share it. It is a matter of controversy among people with ME. Clearly, it is not working for some, but it does appear to help others. Because it is basically about the way that people deal with a long-term condition, it might assist them in dealing with that condition. However, it is probably not a cure in itself—no one is arguing that.
Janice Kent: That is how it is presented.
Mike O’Brien: I don’t want to get into a detailed argument about the lightning process, which I do know a fair amount about. I would say that it seems to be a way in which CBT can be used to help people deal with a long-term condition that would otherwise be more debilitating than it is. Is it a cure? That depends on the extent to which you regard ME as a physical rather than a psychological condition. If people are ill for a long period with a physical condition, they’re also psychologically affected. My basic view about CBT and the lightning process in particular is that it can help people who have long-term illnesses, but that does not necessarily mean that it is the cure for anything. If the illness is caused by physical issues, a psychological response might help the individual to deal with it, but not cure them...
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
But the Minister Mike O’Brien was wrong.
THIS is what Lightning Trainers claim Lightning does, not help with living with ME, but recovery from ME with Lightning:
http://www.light-at-the-end-of-the-tunnel.co.uk/lp_facts_neg_opinions.html
“…the Lightning Process finds
That M.E is totally recoverable from
That over 90% of participants gain recovery from their M.E..”
Dx Revision Watch
Suzy Chapman Owner of Dx Revision Watch
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Extract from the Summary of the ME Association meeting of the Board of Trustees which was held on 15 and 16 November:
http://www.meassociation.org.uk/?p=3059
[...]
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.
------------
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 again following a request for an Internal Review of the University's decision to withhold almost all information that had been requested. 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 comfirmation 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.
So as stated 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, this was widely welcomed 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.
Suzy Chapman
http://www.meassociation.org.uk/?p=3059
[...]
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.
------------
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 again following a request for an Internal Review of the University's decision to withhold almost all information that had been requested. 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 comfirmation 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.
So as stated 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, this was widely welcomed 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.
Suzy Chapman
Dx Revision Watch
Suzy Chapman Owner of Dx Revision Watch
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LP pilot: Minutes of meeting of External Advisory Group held on 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 to post on ME agenda site: http://wp.me/p5foE-3er
On 28 October, I had 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:
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:
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:
That:
Text of Minutes, appended, or open the PDF on ME agenda site here
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
ME agenda Shortlink: http://wp.me/p5foE-3da
Progress on complaints to NRES (ethics approval of SMILE Lightning Process pilot study in children), 16 November 2010
ME agenda 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:
http://meagenda.wordpress.com/category/lightning-process-smile-study/
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 to post on ME agenda site: http://wp.me/p5foE-3er
On 28 October, I had 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.
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...atigue/correspondencewithethics/recfrmrfs.pdf
http://www.bris.ac.uk/ccah/research...atigue/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...e/smilestudydocuments/smileminutesoctober.pdf
http://www.bris.ac.uk/ccah/research...e/smilestudydocuments/smileminutesoctober.pdf
That:
The membership of the group is included in these minutes.
Text of Minutes, appended, or open the PDF on ME agenda site here
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
ME agenda Shortlink: http://wp.me/p5foE-3da
Progress on complaints to NRES (ethics approval of SMILE Lightning Process pilot study in children), 16 November 2010
ME agenda 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:
http://meagenda.wordpress.com/category/lightning-process-smile-study/
Dx Revision Watch
Suzy Chapman Owner of Dx Revision Watch
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Minutes Forward-ME 26 October 2010
"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."
Note: Other than a formal complaint addressed to Joan Kirkbride, NRES, (4 November 2010) which Ms Kirkbride has forwarded, with my permission, to a colleague and to the study Chief Investigator and Sponsor, I should like to clarify that I have had no contact with Dr Esther Crawley, nor her research team, nor the Sponsors nor South West 2 Ethics Committee and that I am dismayed to hear that it has been reported there have been concerns about the content of communications received by Dr Crawley and that this has been recorded in the Minutes of the Forward-ME meeting.
http://www.forward-me.org.uk/26th October 2010.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 Governments opinion is on this matter.
( http://www.publications.parliament.uk/pa/ld201011/ldhansrd/text/101028w0001.htm#10102831000715 )
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 Groups 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.
"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."
Note: Other than a formal complaint addressed to Joan Kirkbride, NRES, (4 November 2010) which Ms Kirkbride has forwarded, with my permission, to a colleague and to the study Chief Investigator and Sponsor, I should like to clarify that I have had no contact with Dr Esther Crawley, nor her research team, nor the Sponsors nor South West 2 Ethics Committee and that I am dismayed to hear that it has been reported there have been concerns about the content of communications received by Dr Crawley and that this has been recorded in the Minutes of the Forward-ME meeting.
http://www.forward-me.org.uk/26th October 2010.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 Governments opinion is on this matter.
( http://www.publications.parliament.uk/pa/ld201011/ldhansrd/text/101028w0001.htm#10102831000715 )
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 Groups 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.
Angela Kennedy
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Crawley's characterisation of 'malicious' correspondence is unsubtantiated, and could quite possibly be merely a subjective description of discomfiting but accurate critique of her trial and her psychogenic explanations for ME or CFS in children.
Needs to be remembered - this sort of thing (unsubstantiated claims of malice applied to legitimate critique) is VERY common in contested issues.
Needs to be remembered - this sort of thing (unsubstantiated claims of malice applied to legitimate critique) is VERY common in contested issues.
Dx Revision Watch
Suzy Chapman Owner of Dx Revision Watch
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Note also:
"It was suggested that it was activities such as this that drove young researchers from the field."
If alleged concerns about content of communications are going to be discussed at Forward-ME meetings, then the organisation rep raising the issue of alleged concerns should be indentified in the Minutes - this has not been done.
Also, this is the second time a suggestion that researchers are being driven from the field has been made at a meeting of Forward-ME.
From the November 2009 Minutes:
http://www.forward-me.org.uk/24th November 2009.htm
[...]
"Peter Spencer said that remarks had been made about the aggressive nature of some of the correspondence together with the number of freedom of information requests from a few members of the ME/CFS community was taking up to 80% of one person’s time at the MRC. It was felt that this was unhelpful as the time could better used for constructive purposes. There was a danger that the hostility to the MRC would be used as ammunition against proposals for research for ME/CFS in what was an extremely competitive field. This was the best opportunity for research support for 10 years and the CFS/ME community should not let it slip through their hands. It was important to get new talent and new technology into the field. It was recognised that the heterogeneity of the disease made it hard to produce proposals."
On this occasion, the source of the "remarks" was not identified.
Angela Kennedy
Senior Member
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These unsubstantiated comments form part of a common, ad nauseum refrain against ME/CFS patients and carers advocating for themselves, a meme which has gone on for years!
It is disgraceful, especially as these charities are NOT effectively advocating instead. People are therefore forced into advocating for themselves and each other because of this LACK of advocacy by certain charities, who have given the power of representation by the government etc.
Absurd situation we all find ourselves in.
It is disgraceful, especially as these charities are NOT effectively advocating instead. People are therefore forced into advocating for themselves and each other because of this LACK of advocacy by certain charities, who have given the power of representation by the government etc.
Absurd situation we all find ourselves in.
Dx Revision Watch
Suzy Chapman Owner of Dx Revision Watch
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Dr Crawley responds to Prof Robin Gill (Church Times 26.11.10)
Dr Esther Crawley responds to Prof Robin Gills 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 Gills concerns about this pilot study can be read in this ME agenda 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 Councils Stem Cell Steering Committee, is President of the Society for the Study of Christian Ethics and Chairs the British Sociological Associations Study Group of Religion.
The current issue of Church Times (Page 19, 26 November 2010) has published a response from Dr Esther Crawley, SMILE pilot study Chief Investigator to Prof Gills letter:
With acknowledgement to the person who kindly alerted me to this response.
Dr Esther Crawley responds to Prof Robin Gills 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 Gills concerns about this pilot study can be read in this ME agenda 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 Councils Stem Cell Steering Committee, is President of the Society for the Study of Christian Ethics and Chairs the British Sociological Associations Study Group of Religion.
The current issue of Church Times (Page 19, 26 November 2010) has published a response from Dr Esther Crawley, SMILE pilot study Chief Investigator to Prof Gills letter:
Professor Gills 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 MRCs 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.
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 MRCs 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.
With acknowledgement to the person who kindly alerted me to this response.
(This may have been mentioned before) There have been no RCTs of GET on children and not many other trials either. Children/parents could use this to claim GET isn't "evidence-based" for children!!
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NHS Online now a venue for promoting Lightning Process.
http://www.nhsonline.net/lifestyle/article.asp?CategoryId=31&ArticleId=4520
http://www.nhsonline.net/lifestyle/article.asp?CategoryId=31&ArticleId=4520
Bob
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That's an excellent point Min... I hadn't thought of that before...
I wonder what 'evidence', if any, Crawley can present to back up her claims?
Bob
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This continuing LP research really does sadden me very much...
I've been trying to write down a clear explanation of the hidden potential dangers that an LP course would expose child ME patients to...
I want it to be so that people who don't know anything about LP or ME can totally understand the risks involved for children...
But the heavy amount of technical writing involved, and organising my information, is beyond my capacity at the moment.
Does anyone have a link to a clear description of what an LP course involves? (i.e. an exact description of what a 'trainee' has to do.)
I know that there's a description somewhere, but I can't remember where...
I want to add it to what I'm writing.
I've been trying to write down a clear explanation of the hidden potential dangers that an LP course would expose child ME patients to...
I want it to be so that people who don't know anything about LP or ME can totally understand the risks involved for children...
But the heavy amount of technical writing involved, and organising my information, is beyond my capacity at the moment.
Does anyone have a link to a clear description of what an LP course involves? (i.e. an exact description of what a 'trainee' has to do.)
I know that there's a description somewhere, but I can't remember where...
I want to add it to what I'm writing.
I wonder does she then think the RCPCH guidelines for children are not evidence-based as they are largely based on evidence from adults from what I recall: http://www.rcpch.ac.uk/doc.aspx?id_Resource=1480 .
Another corollary: the organisers of the trial shouldn't then argue that this trial tells us anything about the effects of LP on adults.
Best of luck. There's some information at: http://www.sayer.abel.co.uk/LP.html
"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."
But I heard these people state that: Myalgic Encephalomyelitis = Chronic Fatigue Syndrome = Chronic Fatigue = Depression = Somatoform Disorder = Neurasthenia = Munchausen Syndrome by Proxy (for under 16s) or Malingering (for over 16s).
If all these different and mutually exclusive disorders are all one of the same how can the statement "CFS/ME in children is not sufficiently close to CFS/ME in adults to mean that research in adults could be extrapolated to children." be credible???
Oh and don't forget: Irritable Bowel Syndrome and Fibromyalgia are also the same disorder as those above!!
But I heard these people state that: Myalgic Encephalomyelitis = Chronic Fatigue Syndrome = Chronic Fatigue = Depression = Somatoform Disorder = Neurasthenia = Munchausen Syndrome by Proxy (for under 16s) or Malingering (for over 16s).
If all these different and mutually exclusive disorders are all one of the same how can the statement "CFS/ME in children is not sufficiently close to CFS/ME in adults to mean that research in adults could be extrapolated to children." be credible???
Oh and don't forget: Irritable Bowel Syndrome and Fibromyalgia are also the same disorder as those above!!
Bob
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Yogi, that's a perfect summary of Wessely's, and the entire psychiatric lobby's view of ME. Perfect!
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Another view of Lighting Process 1
http://www.youtube.com/watch?v=SFGcKmdOVO0
Another view of Lighting Process 2
http://www.youtube.com/watch?v=bDsc0-dJ640&feature=related
Another view of Lighting Process 3
http://www.youtube.com/watch?v=0UvfWW5IA1I&feature=related
http://www.youtube.com/watch?v=SFGcKmdOVO0
Another view of Lighting Process 2
http://www.youtube.com/watch?v=bDsc0-dJ640&feature=related
Another view of Lighting Process 3
http://www.youtube.com/watch?v=0UvfWW5IA1I&feature=related
No. The requirement for all claims to be substantiated by evidence only applies to other people. Crawleys may waive that requirement whenever it is essential to do so in order to uphold a central plank of their case. Besides, the protocol makes it clear. That should be enough for anyone.
Don't let that one go folks, you've got a cast iron case there. Her comment looks like the sign of a crumbling argument to me: if she had a valid argument, she'd use it.