-
Welcome to Phoenix Rising!
Created in 2008, Phoenix Rising is the largest and oldest forum dedicated to furthering the understanding of, and finding treatments for, complex chronic illnesses such as chronic fatigue syndrome (ME/CFS), fibromyalgia, long COVID, postural orthostatic tachycardia syndrome (POTS), mast cell activation syndrome (MCAS), and allied diseases.
To become a member, simply click the Register button at the top right.
Lightning Process to be Evaluated in Research Study on Children
- Thread starter Jenny
- Start date
Dx Revision Watch
Suzy Chapman Owner of Dx Revision Watch
- Messages
- 3,061
- Location
- UK
Min,
The Trustees of charities like Action for M.E. are also its Directors - they don't draw salaries nor do the Trustees of the ME Association.
The Trustees are the Members of Action for M.E.
Sir Peter is a salaried CEO and not a member of the Board of Trustees.
Annual Report & Accounts Year end March 09
http://www.afme.org.uk/res/img/resources/2008 2009 accounts.pdf
The Trustees are listed on Page 3.
Salaries on page 16
Dx Revision Watch
Suzy Chapman Owner of Dx Revision Watch
- Messages
- 3,061
- Location
- UK
http://www.rnhrd.nhs.uk/documents/documents/RNHRD08_09Annual_ReportAccounts.pdf
Annual Report & Accounts Year end 2009
A locked PDF so I cannot paste from it.
Sir Peter was appointed as a Non Executive Director from 2007 for a 4 year term.
As a Non Exec Dir - I don't think he would draw a renumeration. But I'll stand corrected if anyone provides evidence that he does.
Annual Report & Accounts Year end 2009
A locked PDF so I cannot paste from it.
Sir Peter was appointed as a Non Executive Director from 2007 for a 4 year term.
As a Non Exec Dir - I don't think he would draw a renumeration. But I'll stand corrected if anyone provides evidence that he does.
Dx Revision Watch
Suzy Chapman Owner of Dx Revision Watch
- Messages
- 3,061
- Location
- UK
MRC "Expert CFS/ME" panel member Declaration of Interests
http://www.mrc.ac.uk/Utilities/DeclarationsofInterest/MRC006492
Sir Peter Spencer
Personal Remuneration (including employment, pensions, consultancies, directorships, honoraria etc.) [Please identify organisation and category e.g. Wellcome Trust (Pension)]
Non Executive Director Royal National Hospital for Rheumatic Diseases
Action for M.E. salary
Shareholdings and Financial Interests in Companies [please see guidance notes, para 2, for thresholds]
N/A
Research Income during current session [over 50k per grant]
N/A
Major academic collaborators [national and international]
London School of Hygiene and Tropical Medicine
University of East Anglia
University of Hull
Un-remunerated involvement with and membership of medical, bio-medical, pharmaceutical, healthcare provision or science or health policy/communication and similar activities/organisations
N/A
Political/pressure group associations
All Party Parliamentary Group on ME
Any conflicts of interests that may arise out of any known immediate family [see Declaration of Interest Policy para 14 for definition of immediate family) involvement in any of the above. Please indicate which section (1-6) above applies e.g. 1. Oxford University (family)]
None
http://www.mrc.ac.uk/Utilities/DeclarationsofInterest/MRC006492
Sir Peter Spencer
Personal Remuneration (including employment, pensions, consultancies, directorships, honoraria etc.) [Please identify organisation and category e.g. Wellcome Trust (Pension)]
Non Executive Director Royal National Hospital for Rheumatic Diseases
Action for M.E. salary
Shareholdings and Financial Interests in Companies [please see guidance notes, para 2, for thresholds]
N/A
Research Income during current session [over 50k per grant]
N/A
Major academic collaborators [national and international]
London School of Hygiene and Tropical Medicine
University of East Anglia
University of Hull
Un-remunerated involvement with and membership of medical, bio-medical, pharmaceutical, healthcare provision or science or health policy/communication and similar activities/organisations
N/A
Political/pressure group associations
All Party Parliamentary Group on ME
Any conflicts of interests that may arise out of any known immediate family [see Declaration of Interest Policy para 14 for definition of immediate family) involvement in any of the above. Please indicate which section (1-6) above applies e.g. 1. Oxford University (family)]
None
Dx Revision Watch
Suzy Chapman Owner of Dx Revision Watch
- Messages
- 3,061
- Location
- UK
Response to request for Internal Review of FOI responses: Sue Paterson
August 18, 2010
Response from the Director of Legal Services, University of Bristol, to request for an internal review of their FOI responses on the Bath/Bristol Lightning Process pilot study using ME and CFS children aged 8 to 18.
A version of this update is published on ME agenda site here: http://wp.me/p5foE-30R
For background to this issue see ME agenda 5 July report:
Advertising Standards Authority Adjudication: Withinspiration (Lightning Process)
On 22 July, I submitted a formal request for an internal review of the Freedom of Information responses to my request for information of 16 May, for which responses had been received on 17 June.
My complaint was referred to the University of Bristols Director of Legal Services who responded yesterday.
At 17 June, the Universitys Information Rights Officer had stated that the pilot research study, for which it is known that funding had been secured last November, was still going through the ethics approval procedure.
The study is due to start in September. It is known from documents provided under FOI that the funders have stipulated that the study should start by October 2010.
The University is withholding the name(s) of the research ethics committee(s) responsible for considering the application for ethics approval. I have an outstanding request for information submitted to the National Research Ethics Service, due for fulfilment on or before 31 August.
On 10 August, the Universitys Information Rights Officer advised me:
It is unconfirmed, but this more recent information suggests that ethics approval for the pilot study may now have been obtained.
The University of Bristols responses of 17 June can be read here: FOI Lightning Study Chapman 17.06.10
To virtually all questions the response had been:
But it is a matter of considerable public interest that an NHS Trust seeks to use children as young as eight as guinea pigs when no rigorous controlled trials have first been undertaken using an adult patient cohort into the safety, acceptability, long and short-term effects of the application of a previously untrialled research area.
Yesterday (18 August) I received a response from Sue Paterson, Director of Legal Services and Deputy Secretary, Office of the University Secretary, Senate House, Tyndall Avenue, Bristol BS8 1TH.
I consider it unlikely that all information and documents requested on 16 May will be covered.
The formal request for Internal Review of responses received on 17 June 2010 has already been posted on this thread in this posting.
Suzy Chapman
August 18, 2010
Response from the Director of Legal Services, University of Bristol, to request for an internal review of their FOI responses on the Bath/Bristol Lightning Process pilot study using ME and CFS children aged 8 to 18.
A version of this update is published on ME agenda site here: http://wp.me/p5foE-30R
For background to this issue see ME agenda 5 July report:
Advertising Standards Authority Adjudication: Withinspiration (Lightning Process)
On 22 July, I submitted a formal request for an internal review of the Freedom of Information responses to my request for information of 16 May, for which responses had been received on 17 June.
My complaint was referred to the University of Bristols Director of Legal Services who responded yesterday.
At 17 June, the Universitys Information Rights Officer had stated that the pilot research study, for which it is known that funding had been secured last November, was still going through the ethics approval procedure.
The study is due to start in September. It is known from documents provided under FOI that the funders have stipulated that the study should start by October 2010.
The University is withholding the name(s) of the research ethics committee(s) responsible for considering the application for ethics approval. I have an outstanding request for information submitted to the National Research Ethics Service, due for fulfilment on or before 31 August.
On 10 August, the Universitys Information Rights Officer advised me:
that information is intended for publication on the University of Bristol website (URL as yet unconfirmed);
that I would be sent the link once the information is online;
that it is intended that the information relating to the ethics approval is included in the online information and that it was hoped that it would cover my questions 8-10.
that it was hoped that the information published would answer all of the questions posed in my original request;
that it was hoped that the information would be online before the end of August.
that I would be sent the link once the information is online;
that it is intended that the information relating to the ethics approval is included in the online information and that it was hoped that it would cover my questions 8-10.
that it was hoped that the information published would answer all of the questions posed in my original request;
that it was hoped that the information would be online before the end of August.
It is unconfirmed, but this more recent information suggests that ethics approval for the pilot study may now have been obtained.
The University of Bristols responses of 17 June can be read here: FOI Lightning Study Chapman 17.06.10
To virtually all questions the response had been:
This information is intended for future publication when the study protocol and other related documents are published online. It is therefore exempt from disclosure under section 22(1)(a) of the Freedom of Information Act.
The study is currently going through the ethics approval procedure and this information is expected to be published around August / September 2010. We cannot see that there is any public interest in disclosing this information before that time.
The study is currently going through the ethics approval procedure and this information is expected to be published around August / September 2010. We cannot see that there is any public interest in disclosing this information before that time.
But it is a matter of considerable public interest that an NHS Trust seeks to use children as young as eight as guinea pigs when no rigorous controlled trials have first been undertaken using an adult patient cohort into the safety, acceptability, long and short-term effects of the application of a previously untrialled research area.
Yesterday (18 August) I received a response from Sue Paterson, Director of Legal Services and Deputy Secretary, Office of the University Secretary, Senate House, Tyndall Avenue, Bristol BS8 1TH.
Ms Paterson states that I have asked her to review the Information Rights Officers decision to decline to provide certain information in response to my request for information regarding a pilot project relating to the Phil Parker Lightning Process, on the basis that this information is exempt from disclosure under section 22(1)(a) of the Freedom of Information Act 2000 (information intended for future publication).
That the Information Rights Officer has been assured by the leader of this project that the information requested will be published on the Universitys website by the end of this month.
That the published information will include the research protocol and related material, including information about the ethics approval process.
That it is suggested therefore that I await publication of the information and then come back to the Information Rights Officer if there are any aspects of my original request which I consider have not been fulfilled through publication.
That the Information Rights Officer has been assured by the leader of this project that the information requested will be published on the Universitys website by the end of this month.
That the published information will include the research protocol and related material, including information about the ethics approval process.
That it is suggested therefore that I await publication of the information and then come back to the Information Rights Officer if there are any aspects of my original request which I consider have not been fulfilled through publication.
I consider it unlikely that all information and documents requested on 16 May will be covered.
The formal request for Internal Review of responses received on 17 June 2010 has already been posted on this thread in this posting.
Suzy Chapman
Dx Revision Watch
Suzy Chapman Owner of Dx Revision Watch
- Messages
- 3,061
- Location
- UK
ASA Adjudiction write-up in ME Association's "ME Essential"
As you know, on 4 August, the ME Association and The Young ME Sufferers Trust issued a joint statement and press release strongly opposing the pilot study and calling for it to be abandoned.
Their joint press release can be read here.
Tony Britton (MEA Press and Publicity) has said that the press release was issued too late for inclusion in the ME Associations Autumn issue of ME Essential.
But the magazine does include a half page write up, on Page 4, of the Advertising Standards Authority (ASA) adjudication against Lightning Process company Withinspiration.
25% ME Group
On 11 August, Simon Lawrence confirmed to me that the 25% ME Group would be issuing a position statement "soon". No statement has been issued yet.
The MEA and TYMES Trust have been informed of recent information received from the University of Bristol's Information Rights Office concerning the anticipated publication of information and study protocol on the University of Bristol website and a copy of yesterday's Internal Review response from the Director of Legal Services has been provided to both organisations.
Suzy Chapman
As you know, on 4 August, the ME Association and The Young ME Sufferers Trust issued a joint statement and press release strongly opposing the pilot study and calling for it to be abandoned.
Their joint press release can be read here.
Tony Britton (MEA Press and Publicity) has said that the press release was issued too late for inclusion in the ME Associations Autumn issue of ME Essential.
But the magazine does include a half page write up, on Page 4, of the Advertising Standards Authority (ASA) adjudication against Lightning Process company Withinspiration.
25% ME Group
On 11 August, Simon Lawrence confirmed to me that the 25% ME Group would be issuing a position statement "soon". No statement has been issued yet.
The MEA and TYMES Trust have been informed of recent information received from the University of Bristol's Information Rights Office concerning the anticipated publication of information and study protocol on the University of Bristol website and a copy of yesterday's Internal Review response from the Director of Legal Services has been provided to both organisations.
Suzy Chapman
Dx Revision Watch
Suzy Chapman Owner of Dx Revision Watch
- Messages
- 3,061
- Location
- UK
25% ME Group position statement on Lightning Process pilot sudy
It has been brought to my attention, today, that the 25% ME Group has at last issued a position statement.
This is being circulated on Co-Cure, a number of UK ME/CFS boards and there is a copy on the group's website.
It is not known whether this statement is being to sent any individuals, organisations, institutions or bodies.
Proposed Involvement of Children with ‘CFS/ME’ in Research on the ‘Lightning Process’
http://www.25megroup.org/Campaigning/Awareness 2010/MEGrpLPResearch_Statement.doc
This document is heavily formatted. Please download the Word document from the website at the URL above.
It has been brought to my attention, today, that the 25% ME Group has at last issued a position statement.
This is being circulated on Co-Cure, a number of UK ME/CFS boards and there is a copy on the group's website.
It is not known whether this statement is being to sent any individuals, organisations, institutions or bodies.
Proposed Involvement of Children with ‘CFS/ME’ in Research on the ‘Lightning Process’
http://www.25megroup.org/Campaigning/Awareness 2010/MEGrpLPResearch_Statement.doc
This document is heavily formatted. Please download the Word document from the website at the URL above.
Dx Revision Watch
Suzy Chapman Owner of Dx Revision Watch
- Messages
- 3,061
- Location
- UK
Action for M.E. Second position statement
Action for M.E.
20 August 2010
Facebook Wall
Action for M.E. is very concerned that the Lightning Process is being given to children in the UK without having been formally evaluated for effectiveness and safety.
Although the MRC ethics guide says that research involving children shoul...d only be carried out if it cannot feasibly be carried out on adults, there are exceptions eg. studies which aim to increase understanding of child health or shed light on a disease, its natural history and possibilities of prevention.
Before any research is approved, an ethics committee scrutinises the proposals to ensure that the rules about research involving children are satisfied. The committee also ensures that proper safety systems are in place and include safety monitoring by an independent committee.
As long as the ethics committee gives its approval, the charity supports proposals to investigate whether it is possible to set up a controlled trial to look at the Lightning Process and how it compares with current treatments for M.E./CFS in children.
Dr Esther Crawley is a Consultant Paediatrician specialising in CFS/M.E. and a leading researcher in the field. Together with Dr Margaret May and Dr Alan Emond, Dr Crawley has recently published new research on phenotypes of CFS/M.E. in children in the journal Archives of Disease in Childhood.
They showed that there appear to be three different phenotypes: musculoskeletal (the main symptoms being muscle and joint pain), migraine and sore throat. None of the phenotypes were associated with age or length of illness suggesting that they did not merely reflect deconditioning. The lack of association with symptoms of depression or anxiety (with the exception of the migraine phenotype) also suggests that they are unlikely to reflect mood disorders.
Action for M.E.
20 August 2010
Facebook Wall
Action for M.E. is very concerned that the Lightning Process is being given to children in the UK without having been formally evaluated for effectiveness and safety.
Although the MRC ethics guide says that research involving children shoul...d only be carried out if it cannot feasibly be carried out on adults, there are exceptions eg. studies which aim to increase understanding of child health or shed light on a disease, its natural history and possibilities of prevention.
Before any research is approved, an ethics committee scrutinises the proposals to ensure that the rules about research involving children are satisfied. The committee also ensures that proper safety systems are in place and include safety monitoring by an independent committee.
As long as the ethics committee gives its approval, the charity supports proposals to investigate whether it is possible to set up a controlled trial to look at the Lightning Process and how it compares with current treatments for M.E./CFS in children.
Dr Esther Crawley is a Consultant Paediatrician specialising in CFS/M.E. and a leading researcher in the field. Together with Dr Margaret May and Dr Alan Emond, Dr Crawley has recently published new research on phenotypes of CFS/M.E. in children in the journal Archives of Disease in Childhood.
They showed that there appear to be three different phenotypes: musculoskeletal (the main symptoms being muscle and joint pain), migraine and sore throat. None of the phenotypes were associated with age or length of illness suggesting that they did not merely reflect deconditioning. The lack of association with symptoms of depression or anxiety (with the exception of the migraine phenotype) also suggests that they are unlikely to reflect mood disorders.
Dx Revision Watch
Suzy Chapman Owner of Dx Revision Watch
- Messages
- 3,061
- Location
- UK
Re: The 25% ME Group's position statement:
Whilst ME agenda welcomes the issuing of this statement, it should be noted that the press release announcing the pilot study was issued over five and a half months ago.
According to recent communications from the University of Bristol Information Rights Officer and their Director of Legal Sevices, information on the study and the research protocol is anticipated to be published on the University of Bristol website by the end of this month.
This suggests that ethics approval for the pilot study may have been obtained in the last week or two.
Other than issuing this statement, it is not known whether the 25% ME Group has or intends to make representations to any individual, institutions, organisations or bodies.
The Medical Advisors to the 25% ME Group are Dr Byron Hyde (Canada) and former UK NHS paediatrician, Dr Nigel Speight.
Whilst ME agenda welcomes the issuing of this statement, it should be noted that the press release announcing the pilot study was issued over five and a half months ago.
According to recent communications from the University of Bristol Information Rights Officer and their Director of Legal Sevices, information on the study and the research protocol is anticipated to be published on the University of Bristol website by the end of this month.
This suggests that ethics approval for the pilot study may have been obtained in the last week or two.
Other than issuing this statement, it is not known whether the 25% ME Group has or intends to make representations to any individual, institutions, organisations or bodies.
The Medical Advisors to the 25% ME Group are Dr Byron Hyde (Canada) and former UK NHS paediatrician, Dr Nigel Speight.
Are they implying that this "research" would tell us how this disease effects children or how it develops? What a load of bull. How? They won't be doing any biomedical research. Therefore this study does not in any way meet basic requirements to not be viewed as being child abuse.
As for safety requirements, well, when have they ever applied them to psychiatric research. It is all a con.
Their argument is based solely on the fact that the ethics committee have ignored the rules. That's a great bit of analysis, very astute. The Nazi's made lots of decisions too, and people followed them because they were in charge. Brilliant.
As for Crawley, she is no expert, hasn't got a clue. But there it is in black and white, stated by AfME, so it must be true. Well it isn't, and we are not being fooled.
AfME you are a disgrace, your time is up. Prepare to be annihilated. We want the Government to shut you down NOW!
Bob
Senior Member
- Messages
- 16,455
- Location
- England (south coast)
Well, where do we start with a statement like that? ...
If these researchers are investigating phenotypes of ME that include muscle and joint pain, and sore throats, then where exactly does the Lightning Process fit with such phenotypes? Why are they treating children, who have a serious 'musculoskeletal' disorder that causes severe disability, with a psychological program of thought control mechanisms and an artificially enforced system of symptom denial?
Why aren't they treating the symptoms of these children, and investigating the biomedical causes of ME, instead of messing around with potentially damaging wellness belief systems?
I'm certain that they wouldn't treat any children who have AIDS, or any other serious diseases, in this way, so that they get told to deny and ignore their symptoms, and told that they are not really ill but they just have a dysfunctional illness belief which is causing their illness.
Bob
Senior Member
- Messages
- 16,455
- Location
- England (south coast)
I'd like to know which 'exception' the ethics committee is using in order to justify giving this project the go-ahead.
I can't see how any of the exceptions listed here would apply to the Lightning Process.
Bob
Senior Member
- Messages
- 16,455
- Location
- England (south coast)
I don't understand what they mean when using the words 'suggests' and 'unlikely'...
Do they mean that there is, or ever was, a possibility that ME is a mood disorder?
I mean, what world are Action for ME living in? Certainly not the same world that their members have been living in for the past few decades with this decapacitating, debilitating biomedical disease. This really seems to display a massive amount of disrespect to their members, unless I am interpreting their statement wrongly.
eric_s
Senior Member
- Messages
- 1,925
- Location
- Switzerland/Spain (Valencia)
It's 3 in the morning and i've had some champagne, so please forgive me :Retro tongue:
Hey, you people who like to still have theories about childhood abuse on your CFS webpage on this very day, look for the wrong virus with the wrong primer and know in advance what you will find or not find...
Can you guess where you can put your lightning process now??? Yeah, right...
Hey, you people who like to still have theories about childhood abuse on your CFS webpage on this very day, look for the wrong virus with the wrong primer and know in advance what you will find or not find...
Can you guess where you can put your lightning process now??? Yeah, right...
urbantravels
disjecta membra
- Messages
- 1,333
- Location
- Los Angeles, CA
Right on!
Now go get some sleep, for heaven's sake!:sleepy:
Now go get some sleep, for heaven's sake!:sleepy:
Dx Revision Watch
Suzy Chapman Owner of Dx Revision Watch
- Messages
- 3,061
- Location
- UK
Questions for Action for M.E. (Lighting Process pilot study in children)
August 23, 2010
Questions for Action for M.E. (proposed Lighting Process pilot study in children with CFS and ME aged 8 to 18)
Shortlink to this material on ME agenda site: http://wp.me/p5foE-31X
For background to this issue see ME agenda 5 July report:
Advertising Standards Authority (ASA) Adjudication: Withinspiration (Lightning Process)
For joint ME charity opposition statement and press release see:
Joint Press Release and statement: ME Association and The Young ME Sufferers Trust
I have written, today, [23 August] to Action for M.E. requesting clarification of what information they have relied on when formulating their position on this controversial RNHRD NHS FT, Bath/University of Bristol Lightning Process pilot study.
Action for M.E. has now issued two position statements on this proposed Lightning Process pilot study for children.
Although funding for the study had been secured last November and a press release published in early March, by 17 June, the research team were still waiting on an ethics committee decision.
According to information posted on Action for M.E.’s Facebook site on 23 August, the project’s lead researcher, Dr Esther Crawley, has apparently confirmed that the pilot is still waiting to receive ethics approval.
University of Bristol Information Rights Officer and the Director of Legal Services had already confirmed to me (on 10 and 17 August) that the project lead had given assurances that “information requested will be published on the University’s website by the end of this month” and that “the published information will include the research protocol and related material, including information about the ethics approval process”.
It appears then that Dr Crawley is very confident her project will be approved.
The University FOI office has told me that I will be notified when the material is published.
A request for information and documents relating to the application for approval and the approval process timeline is due for fulfilment on or before 31 August. Information requested of the National Research Ethics Service can be read in this posting:
Freedom of Information requests: South West Strategic Health Authority and National Research Ethics Service
To: Policy Officer; Heather Walker, Communications Manager; Sir Peter Spencer, CEO
Sent: Monday, August 23, 2010 4:18 PM
Subject: Query on position statements
This is a query in relation to Action for M.E.’s two published position statements on the proposed Lightning Process pilot study for children.
It was reported, back in March, by the regional Bristol newspaper:
http://www.thisisbath.co.uk/news/Money-Min-children-s-study/article-1885785-detail/article.htm l
“Money for Min children’s study
Thursday, March 04, 2010, 15:29
“A project looking into a chronic childhood condition has been given a 164,000 boost.
[...]
“The team will be carrying out a three-day trial using the Phil Parker Lightning Process, which is designed to teach people a new set of techniques for improving life and health.
“The system is derived from osteopathy, neuro-linguistic programming and life coaching.
“Its creator, osteopath Phil Parker said: “We are thrilled to have the opportunity to collaborate on this exciting and groundbreaking research with Dr Crawley and her team.”
———
As you are aware, the University of Bristol’s FOI office is withholding virtually all information and documents under FOIA Clause 22(1)(a). Some limited documents relating to the funders have been made available.
When the University of Bristol issued its press release published on 2 March 2010 announcing the Lightning Process pilot study, the study had not, at that point, obtained ethics approval.
At 17 June, the University FOI Office confirmed that the study was still going through the ethics approval procedure and that information requested was expected to be published around August/September 2010.
I am recently advised by the FOI Office that Dr Crawley has assured them that information around the study and the research protocol is now planned to be published by the end of August. It is unconfirmed, but this suggests that the study may now have received approval.
So there is very little information in the public domain about the study design and methods.
The only information that is currently publicly available is:
1] The press release announcing the study on 2 March:
http://www.rnhrd.nhs.uk/index_sub_menus/news/documents/FINALRNHRDCFS_ME_fundingfeb10.pdf
2] The media article in “This is Bath” (URL above).
3] An article in the May issue of AYME’s Link Newsletter (a copy can be provided but no URL).
4] The information that Alastair Gibson is one of two LP practitioners involved with the NHS study (was on his website in March but has since been removed).
The “This is Bath” article states:
“The team will be carrying out a three-day trial using the Phil Parker Lightning Process, which is designed to teach people a new set of techniques for improving life and health.”
In five months, this has not been corrected by the lead researcher if this information is misleading.
The press release states that the primary outcome measure will be “school attendance after six-months”.
It seems unlikely, then, that the pilot participants and their families are going to be subjected solely to the application of “in-depth interviews”.
To date, there is virtually no information in the public domain about the proposed study design and methods and the research protocol is not expected to be published until the end of this month.
a) What is Action for M.E.’s understanding of what will be applied to the children during the life of the pilot study and by whom?
Where has it obtained the information on which it has based its decision to support this pilot study and to support any decision by the ethics committee(s) to grant a “favourable opinion”, ie, to approve the application?
b) Would Action for M.E. please set out what information it has relied upon in order to inform its position on this pilot and whether the organisation has made any approaches to the researchers or to any other body to obtain information about the proposed study over and above the press release, and what was the outcome of any approaches made?
Sincerely,
Suzy Chapman
_____________________
http://meagenda.wordpress.com
http://dxrevisionwatch.wordpress.com
http://twitter.com/MEagenda
http://www.facebook.com/MEagenda
August 23, 2010
Questions for Action for M.E. (proposed Lighting Process pilot study in children with CFS and ME aged 8 to 18)
Shortlink to this material on ME agenda site: http://wp.me/p5foE-31X
For background to this issue see ME agenda 5 July report:
Advertising Standards Authority (ASA) Adjudication: Withinspiration (Lightning Process)
For joint ME charity opposition statement and press release see:
Joint Press Release and statement: ME Association and The Young ME Sufferers Trust
I have written, today, [23 August] to Action for M.E. requesting clarification of what information they have relied on when formulating their position on this controversial RNHRD NHS FT, Bath/University of Bristol Lightning Process pilot study.
Action for M.E. has now issued two position statements on this proposed Lightning Process pilot study for children.
Although funding for the study had been secured last November and a press release published in early March, by 17 June, the research team were still waiting on an ethics committee decision.
According to information posted on Action for M.E.’s Facebook site on 23 August, the project’s lead researcher, Dr Esther Crawley, has apparently confirmed that the pilot is still waiting to receive ethics approval.
University of Bristol Information Rights Officer and the Director of Legal Services had already confirmed to me (on 10 and 17 August) that the project lead had given assurances that “information requested will be published on the University’s website by the end of this month” and that “the published information will include the research protocol and related material, including information about the ethics approval process”.
It appears then that Dr Crawley is very confident her project will be approved.
The University FOI office has told me that I will be notified when the material is published.
A request for information and documents relating to the application for approval and the approval process timeline is due for fulfilment on or before 31 August. Information requested of the National Research Ethics Service can be read in this posting:
Freedom of Information requests: South West Strategic Health Authority and National Research Ethics Service
To: Policy Officer; Heather Walker, Communications Manager; Sir Peter Spencer, CEO
Sent: Monday, August 23, 2010 4:18 PM
Subject: Query on position statements
This is a query in relation to Action for M.E.’s two published position statements on the proposed Lightning Process pilot study for children.
It was reported, back in March, by the regional Bristol newspaper:
http://www.thisisbath.co.uk/news/Money-Min-children-s-study/article-1885785-detail/article.htm l
“Money for Min children’s study
Thursday, March 04, 2010, 15:29
“A project looking into a chronic childhood condition has been given a 164,000 boost.
[...]
“The team will be carrying out a three-day trial using the Phil Parker Lightning Process, which is designed to teach people a new set of techniques for improving life and health.
“The system is derived from osteopathy, neuro-linguistic programming and life coaching.
“Its creator, osteopath Phil Parker said: “We are thrilled to have the opportunity to collaborate on this exciting and groundbreaking research with Dr Crawley and her team.”
———
As you are aware, the University of Bristol’s FOI office is withholding virtually all information and documents under FOIA Clause 22(1)(a). Some limited documents relating to the funders have been made available.
When the University of Bristol issued its press release published on 2 March 2010 announcing the Lightning Process pilot study, the study had not, at that point, obtained ethics approval.
At 17 June, the University FOI Office confirmed that the study was still going through the ethics approval procedure and that information requested was expected to be published around August/September 2010.
I am recently advised by the FOI Office that Dr Crawley has assured them that information around the study and the research protocol is now planned to be published by the end of August. It is unconfirmed, but this suggests that the study may now have received approval.
So there is very little information in the public domain about the study design and methods.
The only information that is currently publicly available is:
1] The press release announcing the study on 2 March:
http://www.rnhrd.nhs.uk/index_sub_menus/news/documents/FINALRNHRDCFS_ME_fundingfeb10.pdf
2] The media article in “This is Bath” (URL above).
3] An article in the May issue of AYME’s Link Newsletter (a copy can be provided but no URL).
4] The information that Alastair Gibson is one of two LP practitioners involved with the NHS study (was on his website in March but has since been removed).
The “This is Bath” article states:
“The team will be carrying out a three-day trial using the Phil Parker Lightning Process, which is designed to teach people a new set of techniques for improving life and health.”
In five months, this has not been corrected by the lead researcher if this information is misleading.
The press release states that the primary outcome measure will be “school attendance after six-months”.
It seems unlikely, then, that the pilot participants and their families are going to be subjected solely to the application of “in-depth interviews”.
To date, there is virtually no information in the public domain about the proposed study design and methods and the research protocol is not expected to be published until the end of this month.
a) What is Action for M.E.’s understanding of what will be applied to the children during the life of the pilot study and by whom?
Where has it obtained the information on which it has based its decision to support this pilot study and to support any decision by the ethics committee(s) to grant a “favourable opinion”, ie, to approve the application?
b) Would Action for M.E. please set out what information it has relied upon in order to inform its position on this pilot and whether the organisation has made any approaches to the researchers or to any other body to obtain information about the proposed study over and above the press release, and what was the outcome of any approaches made?
Sincerely,
Suzy Chapman
_____________________
http://meagenda.wordpress.com
http://dxrevisionwatch.wordpress.com
http://twitter.com/MEagenda
http://www.facebook.com/MEagenda