Dx Revision Watch
Suzy Chapman Owner of Dx Revision Watch
- Messages
- 3,061
- Location
- UK
The study is not MRC funded. It is funded by the Linbury Trust and the Ashden Trust (164,000).
Suzy
-
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
The study is not MRC funded. It is funded by the Linbury Trust and the Ashden Trust (164,000).
Suzy
I stand corrected Dolphin & Suzy.
I wrote in haste. I have been bedbound/housebound for getting on 6 years. A sister in laws young niece has just been 'cured' with the LP and now I am being viewed as a psycho case by the rest of the family. This illness is so cruel and divisive.
No problem with me. The MRC have only funded psychobabblers so it is easy to get confused.
The PACE Trial is due soon. It cost 5m of taxpayers' money (MRC, DWP, DoH and Scottish Chief Scientists' Office).
Dx Revision Watch
Suzy Chapman Owner of Dx Revision Watch
- Messages
- 3,061
- Location
- UK
http://www.theyworkforyou.com/wrans/?id=2010-10-28a.311.3&s=speaker:12904
House of Lords Written Question
The Countess of Mar (Crossbench)
To ask Her Majesty's Government what assessment they have made of whether the decision by the South-West Research Ethics Committee to approve a pilot research study into the effects of the Lightning Process on children is consistent with the ethical guidance issued by the Medical Research Council to the effect that clinical trials should only include children where the relevant knowledge cannot be obtained by research on adults, and that research involving adults cannot provide the same benefits.
House of Lords Written Answer
Hansard source (Citation: HL Deb, 28 October 2010, c311W)
http://www.publications.parliament.uk/pa/ld201011/ldhansrd/text/101028w0001.htm#10102831000715
Earl Howe (Parliamentary Under Secretary of State (Quality), Health; Conservative)
Research ethics committees' decisions are expected to be impartial and independent of ministerial and other influences. The Government do not interfere with their deliberations, either while they are in progress or by reviewing the outcome. The practice of research ethics committees is subject to training, accreditation and other quality assurance by the arm's-length National Research Ethics Service to ensure the competence and consistency of their decision-making.
It would be unethical if scientists did not seek to determine the safety and efficacy of treatments and care for all intended beneficiaries, male and female, young and old. When considering whether the particular sample of people proposed as research participants is appropriate, research ethics committees have regard to the established ethical principles reflected in the medicines for Human Use (Clinical Trials) Regulations 2004, international and professional codes of practice and guidelines from funding bodies such as the Medical Research Council (MRC), although the research project in question is neither a drug trial nor funded by the MRC.
House of Lords Written Question
The Countess of Mar (Crossbench)
To ask Her Majesty's Government what assessment they have made of whether the decision by the South-West Research Ethics Committee to approve a pilot research study into the effects of the Lightning Process on children is consistent with the ethical guidance issued by the Medical Research Council to the effect that clinical trials should only include children where the relevant knowledge cannot be obtained by research on adults, and that research involving adults cannot provide the same benefits.
House of Lords Written Answer
Hansard source (Citation: HL Deb, 28 October 2010, c311W)
http://www.publications.parliament.uk/pa/ld201011/ldhansrd/text/101028w0001.htm#10102831000715
Earl Howe (Parliamentary Under Secretary of State (Quality), Health; Conservative)
Research ethics committees' decisions are expected to be impartial and independent of ministerial and other influences. The Government do not interfere with their deliberations, either while they are in progress or by reviewing the outcome. The practice of research ethics committees is subject to training, accreditation and other quality assurance by the arm's-length National Research Ethics Service to ensure the competence and consistency of their decision-making.
It would be unethical if scientists did not seek to determine the safety and efficacy of treatments and care for all intended beneficiaries, male and female, young and old. When considering whether the particular sample of people proposed as research participants is appropriate, research ethics committees have regard to the established ethical principles reflected in the medicines for Human Use (Clinical Trials) Regulations 2004, international and professional codes of practice and guidelines from funding bodies such as the Medical Research Council (MRC), although the research project in question is neither a drug trial nor funded by the MRC.
Dx Revision Watch
Suzy Chapman Owner of Dx Revision Watch
- Messages
- 3,061
- Location
- UK
The request for information under the FOIA that I submitted on 28 October to the University of Bristol Information Rights Officer to establish:
1] The names of all patient organisations who have been involved in the planning/development of the SMILE pilot study.
2] The names of all members of the External Advisory Group and the organisations with which they are associated, where applicable.
is due for fulfillment on or before 24 November.
1] The names of all patient organisations who have been involved in the planning/development of the SMILE pilot study.
2] The names of all members of the External Advisory Group and the organisations with which they are associated, where applicable.
is due for fulfillment on or before 24 November.
Dx Revision Watch
Suzy Chapman Owner of Dx Revision Watch
- Messages
- 3,061
- Location
- UK
Not to worry, Laura. As Dolphin says, it's an easy enough mistake to make given the type of research the MRC has funded in the past.
The breakdown for the funding was (from FOI request, 16 May 2010)
a) Value of grant awarded by the Linbury Trust: 120,000
b) Value of grant awarded by the Ashden Trust: 44,000
c) Any other sources of funding for the pilot study: No other funding sources
The Linbury Trust has funded a number of "CFS" studies in the past and has also funded some previous studies by Dr Crawley's research team.
But the Ashden Trust doesn't appear to have a history of funding health/medical research. Both trusts are associated with the funding arms of the Sainsbury family.
http://www.ashdentrust.org.uk/
http://www.ashdentrust.org.uk/aboutus.html
The trust’s long-term focus on climate change, sustainable development and improving the quality of life in poorer communities allows us to explore a range of ways to tackle these enormous challenges under six category headings:
•Sustainable Development International
•Sustainable Development UK
•Sustainable Regeneration
•People at Risk
•Arts and Sustainability
•Social Investment Fund
------
Which begs the question, why was the Ashden Trust approached by the research team or prevailed upon by the Linbury Trust, to provide 44,000 towards the study, when medical research is not their usual remit?
As part of my FOI to University of Bristol, in May, I had also requested:
22] Please provide copies of the funding application documents.
To which 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.
Copies of some correspondence between Dr Crawley and the funders were released to others who had submitted FOIs around the study. These have been made available to me and I have copies of these letters archived on my website.
But the funding application documents were neither published in September on the University of Bristol website nor have they been provided directly to me and I shall be requesting fulfillment, this coming week.
ETA: The Ashden Trust 2009 Annual Report
http://www.ashdentrust.org.uk/files/Ashden Trust Annual report - 5 April 2009.pdf
Suzy
Dx Revision Watch
Suzy Chapman Owner of Dx Revision Watch
- Messages
- 3,061
- Location
- UK
Dolphin, if you've got the time/energy, perhaps you'd have a quick look at the PDF for the Ashden Trust 2009 Annual Report.
Pages 6 -16 list the awards for that financial period.
http://www.ashdentrust.org.uk/files/Ashden Trust Annual report - 5 April 2009.pdf
This is for Year end 5 April 2009, so it doesn't cover the period during which the grant of 44K was awarded to Dr Crawley's team.
None of the projects it undertook that year that I can see, are in the field of medical research. To be funding a pilot study into the feasiblity of undertaking an RCT comparing the Lightning Process and specialist care in children represents quite a departure.
None of the letters we have obtained, so far, between the lead researcher and the funders sets out a breakdown of projected costings (this would likely be included in the funding application documents).
So it's not clear whether the 44K had been obtained specifically for the economic costs part of the study or towards the project, as a whole.
"This study incorporates the first study on health service use in paediatric CFS/ME. This is necessary for the future RCT and will also enable us to perform additional studies using these resource use inventories on paediatric services nationally."
But if it were for this secondary project, again, this is not an area in which the Ashden Trust normally appears to provide funding for.
Would those responsible within the Ashden Trust for reviewing the application been in a position to make an informed decision on medical research - an area that lies outside their usual range of interests, as a charitable trust?
Suzy
Pages 6 -16 list the awards for that financial period.
http://www.ashdentrust.org.uk/files/Ashden Trust Annual report - 5 April 2009.pdf
This is for Year end 5 April 2009, so it doesn't cover the period during which the grant of 44K was awarded to Dr Crawley's team.
None of the projects it undertook that year that I can see, are in the field of medical research. To be funding a pilot study into the feasiblity of undertaking an RCT comparing the Lightning Process and specialist care in children represents quite a departure.
None of the letters we have obtained, so far, between the lead researcher and the funders sets out a breakdown of projected costings (this would likely be included in the funding application documents).
So it's not clear whether the 44K had been obtained specifically for the economic costs part of the study or towards the project, as a whole.
"This study incorporates the first study on health service use in paediatric CFS/ME. This is necessary for the future RCT and will also enable us to perform additional studies using these resource use inventories on paediatric services nationally."
But if it were for this secondary project, again, this is not an area in which the Ashden Trust normally appears to provide funding for.
Would those responsible within the Ashden Trust for reviewing the application been in a position to make an informed decision on medical research - an area that lies outside their usual range of interests, as a charitable trust?
Suzy
Interesting.
It doesn't neatly fit in with their aims/other projects it would seem.
If it was done on adults as opposed to children, at a stretch perhaps they could go with "People at Risk".
I don't know why they wouldn't have taken all the money from the Linbury Trust another Sainsbury family Trust that has funded various ME/CFS studies before.
As I recall, there have been other Sainsbury family trusts that have also given support to research on ME/CFS at some stage e.g. something with Gatsby in the title?
Dx Revision Watch
Suzy Chapman Owner of Dx Revision Watch
- Messages
- 3,061
- Location
- UK
No, it doesn't.
Yes, I wondered about that and that would be darkly ironic, wouldn't it?
Perhaps there was a shortfall and the Linbury Trust called on the Ashden Trust to make up the difference - possibly the Linbury Trust have a cap on certain categories of award and agreed to award but could not provide funding in excess of 160,000.
Or perhaps Linbury could/would not grant an award for the "ecomomic costs" part of the study* and so the Ashden Trust were approached to award that part (that's if there was a breakdown for the two parts to the study). Or the "ecomomic costs" part of the study was an add-on and applied for later than the main award or was a design requirement of the funders - without the documentation and the history of the funding application, it's not known what the situation was, only that the awards had been formally confirmed by last November, by both Trusts, according to what little documentation I do hold.
* "As part of this study, we will also try and study the cost of the illness to families and measure the cost of treatment."
"This study incorporates the first study on health service use in paediatric CFS/ME. This is necessary for the future RCT and will also enable us to perform additional studies using these resource use inventories on paediatric services nationally."
The Gatsby Charitable Foundation has part funded a National Support Worker for AYME.
http://www.ayme.org.uk/files/annualreport2008.pdf
"May 2008 saw the end of the three-year funding for the National Support Worker (NSW) project from BBC Children in Need. However, the project continued to run for the rest of the year with funding from The Gatsby Charitable Foundation. This is the only national support worker project in the UK for children with ME/CFS. However, its current funding finishes at the end of 2009. If no further funding can be found, the project will be forced to close."
The Gatsby Charitable Foundation are also listed as funders of the Science Media Centre and The Norwich Research Park - a joint venture between the UEA, and amongst others, the Sainsbury Laboratory, which is supported by the UEA and The Gatsby Foundation.
Hopefully, we will know more about the funding application in a few weeks' time.
Suzy
Dx Revision Watch
Suzy Chapman Owner of Dx Revision Watch
- Messages
- 3,061
- Location
- UK
AYME LINK Issue 40: Research study to investigate a chronic childhood condition (SMILE pilot study)
Ed: In the November edition of LINK Newsletter (Issue 40), the Association of Young People with M.E. (AYME) has welcomed the decision by South West 2 Research Ethics Committee to grant ethical approval for the controversial pilot study around the application of the Lightning Process in children as young as 12.
Lead researcher for the SMILE study (Specialist Medical Intervention and Lightning Evaluation), Dr Esther Crawley, is Medical Consultant to AYME.
To date, no rigorous RCTs have been undertaken into the safety, acceptability, short and long-term efficacy of the Lightning Process in adults.
In a joint press release issued in August, two national ME patient organisations The ME Association and The Young ME Sufferers Trust condemned the study as unethical and called for the project to be abandoned.
In a position statement issued in March, Action for M.E. had said it saw no reason to oppose this pilot study.
But in August, Sir Peter Spencer, CEO of Bristol based Action for M.E., disclosed that Action for M.E. has not seen the research protocol for this proposal and has no detailed knowledge of the way in which this trial would be conducted if approved.
Sir Peter Spencer is a non-executive director of the Royal National Hospital for Rheumatic Diseases, NHS Foundation Trust Dr Esther Crawleys employer and the hospital where this research study is being undertaken.
The study hopes to recruit around 90 children aged between 12 to 18 and is expected to start this month. Half the patient cohort will undergo a three day course of the Lightning Process.
According to the NHS REC IRAS application form, the study Protocol and other SMILE study documents published on the University of Bristol website, in September, at:
http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smile.html
"Ethical issues The Lightning Process is popular with over 250 children with CFS/ME attending courses each year. There is therefore an urgent need to study this intervention properly."
"There are currently no reported studies investigating the effectiveness or side effects of the Lightning Process in children. As with all interventions, proper evaluation is necessary if it is to be brought into mainstream practice."
"CFS/ME is different in children and adults with different risk factors [15-17], course and outcome [18]. It is therefore not possible to complete a study in adults and extrapolate the results to children."
"The need for doing a study properly evaluating the Lightning Process came from patients and service users. Representatives from the Association of Young people with ME (AYME) have read, and suggested changes to the protocol and methodology. Service users publicized the research project and are keen to disseminate the findings."
"The PIS [Participant Information Sheet] follows the NRES recommended layout and has adopted the NRES recommendations for children. We have also tested the PIS on healthy teenagers who reported that it was clear to read. Members of the patient charity AYME have scrutinised the PIS and also felt it was clear to read."
"Healthy teenagers have scrutinized the patient information sheets and consent forms. The Chief Executive of AYME will be on the External Advisory Group."
"As this is only a feasibility study, participants will not be individually informed of the outcome. However, the results from the feasibility study will be disseminated through patient charities."
In a response to the ME Association, published on 28 October, Joan Kirkbride, Head of Operations, NRES, has written:
"Given that this treatment is currently available, ME Association survey data suggests it has a similar profile to other therapies and the split opinions in the ME community (this study has the support of particular ME charities who have also been involved in its planning), we feel that a fair way forward is to seek the responses of the researchers, sponsor and the ME charities involved in the development of the study before asking the REC to review its favourable opinion."
I have an FOI in, due for fulfilment on or before 25 November, requesting:
1] The names of all patient organisations who have been involved in the planning/development of the SMILE pilot study.
2] The names of all members of the External Advisory Group and the organisations with which they are associated, where applicable.
-----------------
AYME LINK Issue 40
www.aymelink.org
November 2010
Association of Young People with M.E.
Research study to investigate a chronic childhood condition
A favourable Ethical opinion has been given to a feasibility study which
will see if it is possible to look at two different approaches to the
intervention and treatment of chronic fatigue syndrome/ME (CFS/ME) in
children.
The project called SMILE (Specialist Medical Intervention and Lightning
Evaluation) aims to find out if it is feasible to recruit young people into
a study to compare specialist medical treatment with specialist medical
treatment plus the Lightning Process for young people with chronic fatigue
syndrome or ME (CFS/ME).
The research team will be led by AYME's medical advisor, Dr Esther Crawley,
Consultant Senior Lecturer in the University of Bristol's Centre for Child
and Adolescent Health and Consultant Paediatrician at the Royal National
Hospital for Rheumatic Diseases NHS Foundation Trust and is funded by the
Linbury Trust and the Ashden Trust.
AYME is aware that there are concerns from families about The Phil Parker
Lightning Process.
However, around 250 children a year are already receiving the treatment,
and it seems clear that large numbers will continue to do so. Many of the
families that AYME supports have asked us about LP and it has been
frustrating for us to be able to give them only limited information.
We therefore, welcome this feasibility study to see whether a future study
is possible. In addition, AYME is pleased to see the study group are
looking at how much health resources young people with ME use and are also
investigating the measures clinicians use to look at outcome. If the study
is successful, not only will the team be able to apply for funding for a
larger study to look at effectiveness, but they will also have a lot of
data on the cost of CFS/ME as well as what we need to measure in future
research.
It is important to realise that only a larger study in the future will be
able to investigate whether LP is effective or not which will enable
children and young people and their parents and carers and to make an
informed choice about LP. The study is using a mixture of interview
techniques to understand what young people think about both interventions,
including actually observing and comparing both interventions in order to
understand more about them. The fact that all young people will be closely
monitored by both the clinical and research team is reassuring.
Esther Crawley said: "We are doing this study because so many young people
with ME and their families asked us for this. We are very grateful we can
now go ahead and start to answer some of the questions they have been
asking".
The Phil Parker Lightning Process is an intervention that is used for a
variety of conditions including CFS/ME and has been developed from
osteopathy, coaching and neuro-linguistic programming. It is a three-day
training programme run by registered practitioners and designed to teach
individuals a new set of techniques for improving life and health.
Phil Parker, designer of the Lightning Process said: "It is vitally
important that all interventions that could assist children with CFS/ME to
return to school and improve their health are explored".
What ethical review has SMILE received?
The study has been scrutinised by the South West 2 Research Ethics
Committee whose role it is to ensure that research is safe and ethically
sound. The ethics committee has looked in detail at the study design, and
all associated documentation and suggested improvements to the readability
and accessibility of the patient information leaflets and consent forms
which have been adopted.
The SMILE study is compliant with Good Clinical Practice Guidelines,
Research Governance Framework, Medical Research Council guidelines, Royal
College of Paediatrics and Child Health guidelines for the conduct of
trials and has been approved by an ethics committee.
Further information about this research project, including frequently asked
questions can be found at the URL:
http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smile.html
Ed: In the November edition of LINK Newsletter (Issue 40), the Association of Young People with M.E. (AYME) has welcomed the decision by South West 2 Research Ethics Committee to grant ethical approval for the controversial pilot study around the application of the Lightning Process in children as young as 12.
Lead researcher for the SMILE study (Specialist Medical Intervention and Lightning Evaluation), Dr Esther Crawley, is Medical Consultant to AYME.
To date, no rigorous RCTs have been undertaken into the safety, acceptability, short and long-term efficacy of the Lightning Process in adults.
In a joint press release issued in August, two national ME patient organisations The ME Association and The Young ME Sufferers Trust condemned the study as unethical and called for the project to be abandoned.
In a position statement issued in March, Action for M.E. had said it saw no reason to oppose this pilot study.
But in August, Sir Peter Spencer, CEO of Bristol based Action for M.E., disclosed that Action for M.E. has not seen the research protocol for this proposal and has no detailed knowledge of the way in which this trial would be conducted if approved.
Sir Peter Spencer is a non-executive director of the Royal National Hospital for Rheumatic Diseases, NHS Foundation Trust Dr Esther Crawleys employer and the hospital where this research study is being undertaken.
The study hopes to recruit around 90 children aged between 12 to 18 and is expected to start this month. Half the patient cohort will undergo a three day course of the Lightning Process.
According to the NHS REC IRAS application form, the study Protocol and other SMILE study documents published on the University of Bristol website, in September, at:
http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smile.html
"Ethical issues The Lightning Process is popular with over 250 children with CFS/ME attending courses each year. There is therefore an urgent need to study this intervention properly."
"There are currently no reported studies investigating the effectiveness or side effects of the Lightning Process in children. As with all interventions, proper evaluation is necessary if it is to be brought into mainstream practice."
"CFS/ME is different in children and adults with different risk factors [15-17], course and outcome [18]. It is therefore not possible to complete a study in adults and extrapolate the results to children."
"The need for doing a study properly evaluating the Lightning Process came from patients and service users. Representatives from the Association of Young people with ME (AYME) have read, and suggested changes to the protocol and methodology. Service users publicized the research project and are keen to disseminate the findings."
"The PIS [Participant Information Sheet] follows the NRES recommended layout and has adopted the NRES recommendations for children. We have also tested the PIS on healthy teenagers who reported that it was clear to read. Members of the patient charity AYME have scrutinised the PIS and also felt it was clear to read."
"Healthy teenagers have scrutinized the patient information sheets and consent forms. The Chief Executive of AYME will be on the External Advisory Group."
"As this is only a feasibility study, participants will not be individually informed of the outcome. However, the results from the feasibility study will be disseminated through patient charities."
In a response to the ME Association, published on 28 October, Joan Kirkbride, Head of Operations, NRES, has written:
"Given that this treatment is currently available, ME Association survey data suggests it has a similar profile to other therapies and the split opinions in the ME community (this study has the support of particular ME charities who have also been involved in its planning), we feel that a fair way forward is to seek the responses of the researchers, sponsor and the ME charities involved in the development of the study before asking the REC to review its favourable opinion."
I have an FOI in, due for fulfilment on or before 25 November, requesting:
1] The names of all patient organisations who have been involved in the planning/development of the SMILE pilot study.
2] The names of all members of the External Advisory Group and the organisations with which they are associated, where applicable.
-----------------
AYME LINK Issue 40
www.aymelink.org
November 2010
Association of Young People with M.E.
Research study to investigate a chronic childhood condition
A favourable Ethical opinion has been given to a feasibility study which
will see if it is possible to look at two different approaches to the
intervention and treatment of chronic fatigue syndrome/ME (CFS/ME) in
children.
The project called SMILE (Specialist Medical Intervention and Lightning
Evaluation) aims to find out if it is feasible to recruit young people into
a study to compare specialist medical treatment with specialist medical
treatment plus the Lightning Process for young people with chronic fatigue
syndrome or ME (CFS/ME).
The research team will be led by AYME's medical advisor, Dr Esther Crawley,
Consultant Senior Lecturer in the University of Bristol's Centre for Child
and Adolescent Health and Consultant Paediatrician at the Royal National
Hospital for Rheumatic Diseases NHS Foundation Trust and is funded by the
Linbury Trust and the Ashden Trust.
AYME is aware that there are concerns from families about The Phil Parker
Lightning Process.
However, around 250 children a year are already receiving the treatment,
and it seems clear that large numbers will continue to do so. Many of the
families that AYME supports have asked us about LP and it has been
frustrating for us to be able to give them only limited information.
We therefore, welcome this feasibility study to see whether a future study
is possible. In addition, AYME is pleased to see the study group are
looking at how much health resources young people with ME use and are also
investigating the measures clinicians use to look at outcome. If the study
is successful, not only will the team be able to apply for funding for a
larger study to look at effectiveness, but they will also have a lot of
data on the cost of CFS/ME as well as what we need to measure in future
research.
It is important to realise that only a larger study in the future will be
able to investigate whether LP is effective or not which will enable
children and young people and their parents and carers and to make an
informed choice about LP. The study is using a mixture of interview
techniques to understand what young people think about both interventions,
including actually observing and comparing both interventions in order to
understand more about them. The fact that all young people will be closely
monitored by both the clinical and research team is reassuring.
Esther Crawley said: "We are doing this study because so many young people
with ME and their families asked us for this. We are very grateful we can
now go ahead and start to answer some of the questions they have been
asking".
The Phil Parker Lightning Process is an intervention that is used for a
variety of conditions including CFS/ME and has been developed from
osteopathy, coaching and neuro-linguistic programming. It is a three-day
training programme run by registered practitioners and designed to teach
individuals a new set of techniques for improving life and health.
Phil Parker, designer of the Lightning Process said: "It is vitally
important that all interventions that could assist children with CFS/ME to
return to school and improve their health are explored".
What ethical review has SMILE received?
The study has been scrutinised by the South West 2 Research Ethics
Committee whose role it is to ensure that research is safe and ethically
sound. The ethics committee has looked in detail at the study design, and
all associated documentation and suggested improvements to the readability
and accessibility of the patient information leaflets and consent forms
which have been adopted.
The SMILE study is compliant with Good Clinical Practice Guidelines,
Research Governance Framework, Medical Research Council guidelines, Royal
College of Paediatrics and Child Health guidelines for the conduct of
trials and has been approved by an ethics committee.
Further information about this research project, including frequently asked
questions can be found at the URL:
http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smile.html
- Messages
- 1,446
"The need for doing a study properly evaluating the Lightning Process came from patients and service users."
The interest in Lightning resulted from a systematic nationwide commercial publicity campaign by Phil Parker and the LP trainers, and high profile media hype that was very much aided by Esther Rantzen in the national press, Esther being the President of the ME children's charity AYME, her influence and promotiion of LP should not be underestimated, or ignored by the REC. Also from NLP coaches hyping LP up for ideological reasons and because of their own vested interests in professional practice of LP itself.
The interest in Lightning resulted from a systematic nationwide commercial publicity campaign by Phil Parker and the LP trainers, and high profile media hype that was very much aided by Esther Rantzen in the national press, Esther being the President of the ME children's charity AYME, her influence and promotiion of LP should not be underestimated, or ignored by the REC. Also from NLP coaches hyping LP up for ideological reasons and because of their own vested interests in professional practice of LP itself.
Yes, it's like a pyramid scheme as PP gets money for every person who enrols; also for everyone who trains, the course is expensive so at the very least, the person wants to get their money back.
Dx Revision Watch
Suzy Chapman Owner of Dx Revision Watch
- Messages
- 3,061
- Location
- UK
For U of Bristol FOI office's response to my request for copies of the funding application documents, please see:
Lightning Process pilot study in children (SMILE): request for the funding application documents
Shortlink: http://wp.me/p5foE-3cP
Lightning Process pilot study in children (SMILE): request for the funding application documents
Shortlink: http://wp.me/p5foE-3cP
Dx Revision Watch
Suzy Chapman Owner of Dx Revision Watch
- Messages
- 3,061
- Location
- UK
Response from Joan Kirkbride, NRES
On Thursday, 4 November, I wrote to Ms Joan Kirkbride, Head of Operations, National Research Ethics Service (NRES).
Re: Concerns in response to the favourable opinion handed down by South West 2 REC in September 2010 to the application from Dr Esther Crawley, Principal Investigator for the SMILE (Specialist Medical Intervention and Lightning Evaluation) pilot study
Study Refs: 10/H0206/32, ASH106264, LIN1750
My letter expanded on some of the concerns I had raised with the Director of Legal Services, University of Bristol, in August, in a formal request for an Internal Review of the Information Rights Officer's decision (17 June) to decline to provide certain information in response to my request for information on the basis that this information was exempt from disclosure under section 22(1)(a) of the Freedom of Information Act 2000 (information intended for future publication). I also included other concerns.
I gave Ms Kirkbride permission for my concerns to be forwarded, in full, to any individuals charged with the scrutiny of complaints in response to the decision to grant the Lightning Process pilot study ethics approval, within the NRES, within South West 2 REC and including the sponsors, PI, co-applicants and study funders, by paper or by electronic means, redacted or unredacted of name and contact details, according to NRES protocols.
I requested confirmation that my communication had been received and my concerns noted.
I may publish a copy of my concerns as submitted on 4 November at some future point on my website.
This morning, I have received an acknowledgement from Ms Kirkbride which she has CCd to a colleague who is understood to be involved with the scrutiny of complaints.
I am advised by Ms Kirkbride that:
The standard response being issued by Ms Kirkbride is:
Suzy Chapman
On Thursday, 4 November, I wrote to Ms Joan Kirkbride, Head of Operations, National Research Ethics Service (NRES).
Re: Concerns in response to the favourable opinion handed down by South West 2 REC in September 2010 to the application from Dr Esther Crawley, Principal Investigator for the SMILE (Specialist Medical Intervention and Lightning Evaluation) pilot study
Study Refs: 10/H0206/32, ASH106264, LIN1750
My letter expanded on some of the concerns I had raised with the Director of Legal Services, University of Bristol, in August, in a formal request for an Internal Review of the Information Rights Officer's decision (17 June) to decline to provide certain information in response to my request for information on the basis that this information was exempt from disclosure under section 22(1)(a) of the Freedom of Information Act 2000 (information intended for future publication). I also included other concerns.
I gave Ms Kirkbride permission for my concerns to be forwarded, in full, to any individuals charged with the scrutiny of complaints in response to the decision to grant the Lightning Process pilot study ethics approval, within the NRES, within South West 2 REC and including the sponsors, PI, co-applicants and study funders, by paper or by electronic means, redacted or unredacted of name and contact details, according to NRES protocols.
I requested confirmation that my communication had been received and my concerns noted.
I may publish a copy of my concerns as submitted on 4 November at some future point on my website.
This morning, I have received an acknowledgement from Ms Kirkbride which she has CCd to a colleague who is understood to be involved with the scrutiny of complaints.
I am advised by Ms Kirkbride that:
She is appending a copy of the standard response which NRES is sending to all respondents on this matter.
That she advises that NRES "do feel that they now have sufficient information available to [them] and that no new issues are being raised in correspondence which is being sent to [them] for consideration".
That she has copied my email to the Chief Investigator and Sponsor as I had given permission to do so.
That I "had raised a number of specific questions outside the remit of NRES where [they] cannot provide a response and the answer to my questions would need to come from either the CI [Chief Investigator] or the sponsor".
That she advises that NRES "do feel that they now have sufficient information available to [them] and that no new issues are being raised in correspondence which is being sent to [them] for consideration".
That she has copied my email to the Chief Investigator and Sponsor as I had given permission to do so.
That I "had raised a number of specific questions outside the remit of NRES where [they] cannot provide a response and the answer to my questions would need to come from either the CI [Chief Investigator] or the sponsor".
The standard response being issued by Ms Kirkbride is:
"NRES has received the submissions from the ME society [The ME Association] and others concerning the SMILE study, a children's study investigating treatment of ME in this age group.
"Following our Standard Operating Procedures we have collated the information we've received and will work with the REC to consider it.
"Given that this treatment is currently available, ME society survey data suggests it has a similar profile to other therapies and the split opinions in the ME community (this study has the support of particular ME charities who have also been involved in its planning) we feel that a fair way forward is to seek the responses of the researchers, sponsor and the ME charities involved in the development of the study before asking the REC to review its favourable opinion. We also note that in this project, subjects will not be deprived of what is current care in this clinic. Research participants will receive this intervention in addition to their standard treatment.
"We will also be seeking the views of our National Research Ethics Panel."
"Following our Standard Operating Procedures we have collated the information we've received and will work with the REC to consider it.
"Given that this treatment is currently available, ME society survey data suggests it has a similar profile to other therapies and the split opinions in the ME community (this study has the support of particular ME charities who have also been involved in its planning) we feel that a fair way forward is to seek the responses of the researchers, sponsor and the ME charities involved in the development of the study before asking the REC to review its favourable opinion. We also note that in this project, subjects will not be deprived of what is current care in this clinic. Research participants will receive this intervention in addition to their standard treatment.
"We will also be seeking the views of our National Research Ethics Panel."
Suzy Chapman
Dx Revision Watch
Suzy Chapman Owner of Dx Revision Watch
- Messages
- 3,061
- Location
- UK
I am advised that at least two others who wrote to Joan Kirkbride, last week, have received the same response, today, and have been asked to forward their concerns directly to the CI and the Sponsor if they had not given permission for their concerns to be forwarded to other parties, within their letters.
Suzy Chapman
Suzy Chapman
BBC Radio Berkshire: MEA arrange follow-up discussion on the Lightning Process
by tonybritton on November 9, 2010
MEA medical adviser Dr Charles Shepherd has been talking to BBC Radio Berkshire and they are going to do a follow up item to the programme in which Esther Ranzten covered the XMRV blood ban and the Lightning Process on Monday 1 November see here.
The aim this time is to cover the Lightning Process in more detail and also discuss recovery rates in ME/CFS.
At present, this item is planned for 9.40am on Thursday 11 November during the Anne Diamond programme.
BBC Radio Berkshire can be listened to live on the BBC website at http://news.bbc.co.uk/local/berkshire/hi/tv_and_radio/
by tonybritton on November 9, 2010
MEA medical adviser Dr Charles Shepherd has been talking to BBC Radio Berkshire and they are going to do a follow up item to the programme in which Esther Ranzten covered the XMRV blood ban and the Lightning Process on Monday 1 November see here.
The aim this time is to cover the Lightning Process in more detail and also discuss recovery rates in ME/CFS.
At present, this item is planned for 9.40am on Thursday 11 November during the Anne Diamond programme.
BBC Radio Berkshire can be listened to live on the BBC website at http://news.bbc.co.uk/local/berkshire/hi/tv_and_radio/
Dx Revision Watch
Suzy Chapman Owner of Dx Revision Watch
- Messages
- 3,061
- Location
- UK
Dx Revision Watch
Suzy Chapman Owner of Dx Revision Watch
- Messages
- 3,061
- Location
- UK
So Rantzen (with a known COI) hijacks a blood ban focussed interview to promote her pet LP; people complain to the BBC and the result? The BBC responds by giving LP more airtime!
I was advised today that this page has been recently taken off line:
http://web.archive.org/web/20080326165601/http://www.healinghawk.com/prospectushealing.htm
Rats!
I was advised today that this page has been recently taken off line:
http://web.archive.org/web/20080326165601/http://www.healinghawk.com/prospectushealing.htm
Rats!
