eric_s
Senior Member
- Messages
- 1,925
- Location
- Switzerland/Spain (Valencia)
Yes, thanks, i went to see a friend, then some hours of sleep...
-
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
I have received a response from Sir Peter Spencer, CEO, Action for M.E, this afternoon.
Sir Peter writes that [Action for M.E.'s] position derives from their detailed reading of the MRC Ethics Guide for medical research involving children and from their understanding of the role of any ethics committee in satisfying itself that appropriate independent arrangements are in place to ensure patient safety.
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.
That [Action for M.E.] does, of course, want to see research into LP in adults too - but as children are already seeing LP practitioners, before the process has been subject to research published in respected peer-reviewed journals, [they] can see a case for investigating if it is feasible within the Ethics Guide to set up a controlled trial.
Sir Peter writes that [Action for M.E.'s] position derives from their detailed reading of the MRC Ethics Guide for medical research involving children and from their understanding of the role of any ethics committee in satisfying itself that appropriate independent arrangements are in place to ensure patient safety.
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.
That [Action for M.E.] does, of course, want to see research into LP in adults too - but as children are already seeing LP practitioners, before the process has been subject to research published in respected peer-reviewed journals, [they] can see a case for investigating if it is feasible within the Ethics Guide to set up a controlled trial.
Dx Revision Watch
Suzy Chapman Owner of Dx Revision Watch
- Messages
- 3,061
- Location
- UK
Latest on ethics approval
Yesterday, 25 August, I responded to an email from the University of Bristol Information Rights Officer, in which I requested clarification of the status of ethics approval.
I wrote:
Thank you for your response.
In your earlier response (10 August) you said that you will be forwarding a link once the information is online.
I would welcome this.
There is some confusion over the status of ethics approval.
It has been published on the internet by an individual who has recently obtained clarification from the lead researcher, Dr Crawley, that the pilot study is still waiting on ethics approval.
Which seems at variance with the information from your Director of Legal Services, Ms Paterson, that:
"The Information Rights Officer has been assured by the leader of this
project that the information requested will be published on the
University's website by the end of this month. The published information
will include the research protocol and related material, including
information about the ethics approval process."
Is it the case then, that information about the study and the ethics approval process is intended to be published on the website irrespective of whether the study obtains the approval of the research ethics committee responsible for reviewing the application?
The Information Rights Officer has responded, this morning, that:
"The study is at the final stage of the ethics proposal. The information will be published regardless."
Yesterday, 25 August, I responded to an email from the University of Bristol Information Rights Officer, in which I requested clarification of the status of ethics approval.
I wrote:
Thank you for your response.
In your earlier response (10 August) you said that you will be forwarding a link once the information is online.
I would welcome this.
There is some confusion over the status of ethics approval.
It has been published on the internet by an individual who has recently obtained clarification from the lead researcher, Dr Crawley, that the pilot study is still waiting on ethics approval.
Which seems at variance with the information from your Director of Legal Services, Ms Paterson, that:
"The Information Rights Officer has been assured by the leader of this
project that the information requested will be published on the
University's website by the end of this month. The published information
will include the research protocol and related material, including
information about the ethics approval process."
Is it the case then, that information about the study and the ethics approval process is intended to be published on the website irrespective of whether the study obtains the approval of the research ethics committee responsible for reviewing the application?
The Information Rights Officer has responded, this morning, that:
"The study is at the final stage of the ethics proposal. The information will be published regardless."
Dx Revision Watch
Suzy Chapman Owner of Dx Revision Watch
- Messages
- 3,061
- Location
- UK
Update on ethics approval for the Dr Esther Crawley led RNHRD NHS FT Bath/University of Bristol Lightning Process pilot study for children aged 8 to 18
Shortlink: http://wp.me/p5foE-341
On 3 August, I submitted a request for information to the National Research Ethics Service (NRES) under the Freedom of Information Act around the application for ethics approval and application timeline.
This was fulfilled yesterday, 27 August.
I received the following responses provided by the FOI Manager, NHS South West. Responses are highlighted in blue:
27 August 2010
Royal National Hospital for Rheumatic Diseases NHS Foundation Trust and the University of Bristol
Funders: 164,000 awarded by Linbury Trust and the Ashden Trust
Lead researcher: Dr Esther Crawley, Consultant Paediatrician, Royal National Hospital for Rheumatic Diseases, Bath, Senior Lecturer, University of Bristol.
Study: Pilot project to investigate how to recruit to a randomised controlled trial looking at the Phil Parker Lightning Process and specialist medical care in CFS/ME in children. Project to incorporate study on health economic cost of CFS/ME in children.
Ethics Approval:
1] Any reference numbers attached to the application for ethics approval: 10/H0206/32
2] Names of Research Ethics Committee(s) responsible for reviewing application: [A South West region Research Ethics Committee is identified]
Status of application for ethics approval:
3] Date application received: 14 June 2010
Has a Research Ethics Committee already met to consider this application? Yes
On what date did this meeting take place? 08 July 2010
Was an unfavourable ethical opinion or a favourable ethical opinion given? A decision is awaited on the ethical opinion.
If an unfavourable opinion, has the applicant re-submitted, submitted modifications or appealed, and on what date were these received? Not applicable
Were any clarifications requested? This information is exempt under Section 22 of the Act (information intended for future publication) as it will be published by the University of Bristol in the foreseeable future.
Was a modified application submitted to a different REC and if so, which REC? No
If an appeal was submitted was the application reviewed by a different REC and if so, which REC? Not applicable
What was the outcome of any re-submission, modification or appeal and on what date was the Principal Investigator/lead researcher applicant notified of the outcome? Not applicable
If a favourable opinion, on what date was the Principal Investigator/lead researcher/applicant notified? Not applicable
If the application has yet to be considered, which Research Ethics Committee is responsible for considering this application and on what date is the committee expected to meet to consider the application? Not applicable
By what date is the Principal Investigator/lead researcher/applicant expected to be notified of the opinion? This date is not yet known.
Please provide copies of applications for research ethics approval for the study, including any accompanying documentation that forms part of the application, for example, questionnaires, interview protocol.
Please provide copies of any ethical opinions already handed down, with any requests for resubmissions, modifications, requests for clarifications.
This information is exempted under Section 22 (information intended for future publication) as the University of Bristol plans to publish this information in the foreseeable future.
I am advised that I have the right to complain about this response by reference to the complaints procedure of the South West Strategic Health Authority in which case I should write to the Chief Executive at NHS South West, South West House, Blackbrook Park Avenue, Taunton, Somerset TA1 2PX. That if I remain dissatisfied with the decision of the Authority following my complaint, I may write to the Information Commissioner, whose address is: Information Commissioners Office, Wycliffe House, Water Lane, Wilmslow, Cheshire SK9 5AF.
Related information:
REC Application flowchart
REC Application Researcher Training Pack
FOI request 16 May 2010 to University of Bristol, fulfilled 17 June
Background to this issue
ME Association and The Young ME Sufferers Trust joint Press Release, 4 August 10
Archive for all Lightning Process posts on ME agenda
Shortlink: http://wp.me/p5foE-341
On 3 August, I submitted a request for information to the National Research Ethics Service (NRES) under the Freedom of Information Act around the application for ethics approval and application timeline.
This was fulfilled yesterday, 27 August.
I received the following responses provided by the FOI Manager, NHS South West. Responses are highlighted in blue:
27 August 2010
Royal National Hospital for Rheumatic Diseases NHS Foundation Trust and the University of Bristol
Funders: 164,000 awarded by Linbury Trust and the Ashden Trust
Lead researcher: Dr Esther Crawley, Consultant Paediatrician, Royal National Hospital for Rheumatic Diseases, Bath, Senior Lecturer, University of Bristol.
Study: Pilot project to investigate how to recruit to a randomised controlled trial looking at the Phil Parker Lightning Process and specialist medical care in CFS/ME in children. Project to incorporate study on health economic cost of CFS/ME in children.
Ethics Approval:
1] Any reference numbers attached to the application for ethics approval: 10/H0206/32
2] Names of Research Ethics Committee(s) responsible for reviewing application: [A South West region Research Ethics Committee is identified]
Status of application for ethics approval:
3] Date application received: 14 June 2010
Has a Research Ethics Committee already met to consider this application? Yes
On what date did this meeting take place? 08 July 2010
Was an unfavourable ethical opinion or a favourable ethical opinion given? A decision is awaited on the ethical opinion.
If an unfavourable opinion, has the applicant re-submitted, submitted modifications or appealed, and on what date were these received? Not applicable
Were any clarifications requested? This information is exempt under Section 22 of the Act (information intended for future publication) as it will be published by the University of Bristol in the foreseeable future.
Was a modified application submitted to a different REC and if so, which REC? No
If an appeal was submitted was the application reviewed by a different REC and if so, which REC? Not applicable
What was the outcome of any re-submission, modification or appeal and on what date was the Principal Investigator/lead researcher applicant notified of the outcome? Not applicable
If a favourable opinion, on what date was the Principal Investigator/lead researcher/applicant notified? Not applicable
If the application has yet to be considered, which Research Ethics Committee is responsible for considering this application and on what date is the committee expected to meet to consider the application? Not applicable
By what date is the Principal Investigator/lead researcher/applicant expected to be notified of the opinion? This date is not yet known.
Please provide copies of applications for research ethics approval for the study, including any accompanying documentation that forms part of the application, for example, questionnaires, interview protocol.
Please provide copies of any ethical opinions already handed down, with any requests for resubmissions, modifications, requests for clarifications.
This information is exempted under Section 22 (information intended for future publication) as the University of Bristol plans to publish this information in the foreseeable future.
I am advised that I have the right to complain about this response by reference to the complaints procedure of the South West Strategic Health Authority in which case I should write to the Chief Executive at NHS South West, South West House, Blackbrook Park Avenue, Taunton, Somerset TA1 2PX. That if I remain dissatisfied with the decision of the Authority following my complaint, I may write to the Information Commissioner, whose address is: Information Commissioners Office, Wycliffe House, Water Lane, Wilmslow, Cheshire SK9 5AF.
Related information:
REC Application flowchart
REC Application Researcher Training Pack
FOI request 16 May 2010 to University of Bristol, fulfilled 17 June
Background to this issue
ME Association and The Young ME Sufferers Trust joint Press Release, 4 August 10
Archive for all Lightning Process posts on ME agenda
Dx Revision Watch
Suzy Chapman Owner of Dx Revision Watch
- Messages
- 3,061
- Location
- UK
Lightning Process: further statement from ME Association and Young ME Sufferers Trust
Lightning Process: further statement from ME Association and Young ME Sufferers Trust
September 1, 2010
Shortlink: http://wp.me/p5foE-35q
Lightning Process: further statement from ME Association and Young ME Sufferers Trust
Wednesday, 01 September 2010 09:08
On 4 August 2010 The ME Association and The Young ME Sufferers Trust (Tymes Trust) issued a joint statement that expressed a number of concerns about the proposal to carry out a feasibility study, involving children and adolescents with ME/CFS, into the use of the Lightning Process.
The statement can be read here
We also sent a copy of this statement to the Department of Health with a request that it should be forwarded to the ethics committee that will be examining this proposal. This is because we believe the ethics committee should be aware of widespread concerns being expressed by people with ME/CFS about the trial. Our statement also contained information about an adjudication from the Advertising Standards Authority and interventions by several trading standards officials both in relation to therapeutic claims being made for the Lightning Process which we believe the ethics committees must be aware of when reviewing this proposal.
The Department of Health have refused to forward this information to the ethics committee on the grounds that
We expect research ethics committees to consider all the relevant evidence, but they have to be seen do so objectively and impartially and to arrive at their decisions independently if they are to command public confidence and the credibility of all the stakeholders concerned. For this reason, it would be inappropriate, as well as potentially counterproductive, expressly to bring your joint statement to the attention of the research ethics committee reviewing the proposal for this project..
We profoundly disagree with the DoHs reasoning, which we consider carries serious implications for the integrity of the scientific process. Whether or not an ethics committee membership is confidential, it should still be possible for essential evidence to be supplied to them. How else can the public be assured that an ethics committee has all the relevant evidence to consider before reaching its decision?
The two charities are unable to forward this statement direct because the identity and location of the relevant ethics committee is not in the public domain
We are now considering what further action to take.
[Ends]
Lightning Process: further statement from ME Association and Young ME Sufferers Trust
September 1, 2010
Shortlink: http://wp.me/p5foE-35q
Lightning Process: further statement from ME Association and Young ME Sufferers Trust
Wednesday, 01 September 2010 09:08
On 4 August 2010 The ME Association and The Young ME Sufferers Trust (Tymes Trust) issued a joint statement that expressed a number of concerns about the proposal to carry out a feasibility study, involving children and adolescents with ME/CFS, into the use of the Lightning Process.
The statement can be read here
We also sent a copy of this statement to the Department of Health with a request that it should be forwarded to the ethics committee that will be examining this proposal. This is because we believe the ethics committee should be aware of widespread concerns being expressed by people with ME/CFS about the trial. Our statement also contained information about an adjudication from the Advertising Standards Authority and interventions by several trading standards officials both in relation to therapeutic claims being made for the Lightning Process which we believe the ethics committees must be aware of when reviewing this proposal.
The Department of Health have refused to forward this information to the ethics committee on the grounds that
We expect research ethics committees to consider all the relevant evidence, but they have to be seen do so objectively and impartially and to arrive at their decisions independently if they are to command public confidence and the credibility of all the stakeholders concerned. For this reason, it would be inappropriate, as well as potentially counterproductive, expressly to bring your joint statement to the attention of the research ethics committee reviewing the proposal for this project..
We profoundly disagree with the DoHs reasoning, which we consider carries serious implications for the integrity of the scientific process. Whether or not an ethics committee membership is confidential, it should still be possible for essential evidence to be supplied to them. How else can the public be assured that an ethics committee has all the relevant evidence to consider before reaching its decision?
The two charities are unable to forward this statement direct because the identity and location of the relevant ethics committee is not in the public domain
We are now considering what further action to take.
[Ends]
Dx Revision Watch
Suzy Chapman Owner of Dx Revision Watch
- Messages
- 3,061
- Location
- UK
Landmark agreement extends ASA's digital remit
A version of this post is published on ME agenda and Co-Cure:
Landmark agreement extends ASA's digital remit
It is of considerable public concern that Dr Esther Crawley has sought to obtain the advice, guidance and involvement of a Lightning Process practitioner who, in June, was subject to an Advertising Standards Authority (ASA) ruling in relation to claims being made in an advertisement about the efficacy of the Lightning Process for CFS and ME [1].
In July, I reported that Bournemouth Lightning Process instructor, Alastair Gibson, had already identified himself, on the "Withinspiration website", as "one of the two practitioners working with the NHS and the young people" in the Dr Crawley led pilot study into Lightning Process for children aged 8 to 18.
At 29 March, Mr Gibson's website had carried this information:
http://www.withinspiration.co.uk/index.php
"Breaking News - NHS and Lightning Process research collaboration.
"A new pilot study involving the Lightning Process and the NHS has been awarded 164,000 for research into the treatment of CFS/ME in children and adolescents. Alastair Gibson is one of the two practitioners working with the NHS and the young people in this exciting research study. Find out more."
That statement no longer appears on his website and it is unclear whether Mr Gibson retains an involvement with this proposed pilot study.
At 27 August, according to the University's FOI officer, the study had yet to obtain ethics approval. A research protocol and other information was supposed to have been published on the University of Bristol's website by the end of August - regardless of whether the study gained approval.
This material has failed to appear.
The Old Bailey Online site is a fully searchable collection of 197,745 criminal trials held at London's central criminal court:
In the 1700s, Old Bailey court reports included advertisements and this one caught my eye:
Old Bailey Proceedings, 27th February 1712:
"All Melancholy, Hysterical and Hypochondriacal Distempers, which variously
affect the Mind with strange Fears, and dismal Apprehensions, Paintings,
and Sinkings of the Spirits, great Hurries, Restlesness and Disquietment
(little understood, and seldom cured by any common Means) also Pains and
Giddiness of the Head, Risings to the Throat, Sick-fits, Tremblings,
Oppressions of the Heart, or any other Disorders caus'd by Vapours, are
successfully cured (with God's Blessing) by a Physician well experienc'd
therein, and of more than 20 Years Practice in those deplorable Cases; who
also cures all kind of Fits, tho' strange and violent, if curable; which he
informs on sight of their Water. Living next door to Shadwell Coffee-House
in Upper-Shadwell, near London; where those that have occasion, and live
remote, may direct their Letters, and they shall be speedily answer'd, or
attended on, if desired."
Well little changes, because in 2010, the sites of some Lightning Process practitioners are still making the following claims:
"What does it work for?
"People using the Lightning Process have also recovered from, or
experienced significant improvement with the following conditions: -
"Fibromyalgia
Chronic Fatigue Syndrome
Post Viral Fatigue
Asthma
Rheumatoid Arthritis
Hayfever
Depression
Dyspraxia
Bipolar Disorder
Ocd
Anxiety And Panic Attacks
Insomnia
Cerebral Palsy
Low Self Esteem
Parkinsons Tremors
Motor Neurone Disease
Hyper And Hypo Thyroidism
Chronic Aches And Pains
Ibs
Lyme Disease
Anger Issues
Food Intolerances
Coeliac Disease
Ptsd
Candida
Allergies
Type 2 Diabetes
Interstitial Cystitis
Migraines
Noise And Light Sensitivity
And Many More
"Using the Lightning Process has proven effective for clearing ALL the
debilitating physical and mind based symptoms of ME, chronic fatigue
syndrome, and post viral syndrome.
"Some of the symptoms that people have cleared are listed here...
"Addictions, adrenal problems, allergies and intolerances, anxiety, balance
problems, bloating, blurry vision, brain fog, candida, chemical
sensitivity, compulsive behaviours, concentration problems, confusion,
constipation, depression, diarrhoea, dizziness, electrical pulsing
sensations, excessive sleeping, exhaustion, fatigue, fear, feeling detached
or disconnected, fever and chills, flu-like symptoms, frequent coughs and
colds, fybromyalgia, hallucinations, head pain or pressure, heartburn,
indigestion, insomnia and other sleep disturbances, irritability, irritable
bowel syndrome, itching and rashes, itchy eyes, joint pain, light
sensitivity, loss of vision, malaise, memory loss, migraines, muscle pain,
nausea, noise sensitivity, oedema, panic attacks, painful and/or swollen
glands, pins and needles, restless leg syndrome, runny nose, sensitivity to
electrical fields/computers/mobiles etc, shaking, shooting pains, skin
sensitivity, stomach pain, sun burn sensation, swelling, temperature
control problems, thrush, thyroid problems, unrefreshing sleep, vertigo and
similar sensations, vomiting, water retention, watering eyes,
weakness.....and probably many more
"We advise you to consult your GP, have the necessary tests and obtain a
diagnosis before applying for the Lightning Process training programme"
The Phil Parker Lightning Process website and the sites of some Lightning Process practitioners have a "FAQ" page which includes the following:
"Can my doctor assess me for readiness?
"If your doctor or health care specialist is trained as a Lightning Process
Practitioner then of course they can assess you for readiness to take the
programme. If they are not trained in the programme they will not have the
requisite skills or knowledge base about this very specialised field to
assess you.
"A large part of the training for LP practitioners is to train them to
appropriately assess potential trainees for their suitability for the
process, as it is essential to ensure, as far as is possible, that only
those who are ready to get benefits from the training program are enrolled
in the training."
So, according to Mr Parker, your doctor is not capable of assessing patients for "readiness" to undertake the Lightning Process.
How and by whom are the potential child participants in the RNHRD NHS FT Bath/University of Bristol pilot study going to be assessed for "readiness" and suitability to undertake the "training"?
We don't know, because the University of Bristol is withholding virtually all information requested by me under Clause 22(1)(a) of the FOI Act.
Currently, the Advertising Standards Authority's remit does not extend to website content. But this is to change in March 2011.
The Advertising Standards Authority has issued this news release today:
http://asa.org.uk/Media-Centre/2010/ASA-digital-remit-extension.aspx
1 September 2010
The digital remit of the Advertising Standards Authority (ASA) is to be
extended significantly to deliver more comprehensive consumer protection
online.
The ASA's present remit online includes ads in paid-for space and sales
promotions wherever they appear. But from next year, the rules in the UK
Code of Non-broadcast Advertising, Sales Promotion and Direct Marketing
(the CAP Code) will apply in full to marketing communications online,
including the rules relating to misleading advertising, social
responsibility and the protection of children. The remit will apply to all
sectors and all businesses and organisations regardless of size.
The Committee of Advertising Practice (CAP), the body responsible for
writing the CAP Code, has decided to extend the digital remit of the ASA in
response to a formal recommendation from a wide cross-section of UK
industry. CAP has today published a document detailing the new remit and
sanctions.
http://asa.org.uk/Media-Centre/2010/~/media/Files/CAP/Codes/CAP Digital Remit Extension.ashx
In summary:
The new remit will ensure the same high standards as in other media and
will cover:
. Advertisers' own marketing communications on their own websites and;
. Marketing communications in other non-paid-for space under their
control, such as social networking sites like Facebook and Twitter.
Journalistic and editorial content and material related to causes and
ideas - except those that are direct solicitations of donations for
fund-raising - are excluded from the remit.
Sanctions
In addition to the ASA's present sanctions, which already achieve a high
level of compliance, CAP member bodies have agreed new sanctions to apply
to the extended remit such as:
. Removal of paid-for search advertising - ads that link to the page
hosting the non-compliant marketing communication may be removed with the
agreement of the search engines.
. ASA paid-for search advertisements - the ASA could place
advertisements online highlighting an advertiser?s continued
non-compliance.
Funding
The industry has agreed to apply the standard 0.1% levy on paid-for
advertisements appearing on internet search engines through media and
search agencies. This is an extension of the existing funding mechanism in
other media that pays for the ASA and it will be supplemented initially
with seed capital from Google.
Implementation
The remit will come into force on 1 March 2011 after a six month period of
grace to allow the ASA and CAP to conduct training work to raise awareness
and educate business on the requirements of the CAP Code, particularly
amongst those who may not previously have been subject to ASA regulation.
Website owners and agencies are urged to sign up to CAP Services to receive
guidance and training to help ensure their sites comply with the new rules
before 1 March 2011. ( http://bcap.org.uk/CAPServices.aspx )
ASA Chairman Lord Chris Smith said, "This significant extension of the
ASA's remit has the protection of children and consumers at its heart. We
have received over 4,500 complaints since 2008 about marketing
communications on websites that we couldn?t deal with, but from 1 March
anyone who has a concern about a marketing communication online will be
able to turn to the ASA."
CAP Chairman Andrew Brown said, "Extending the online remit of the ASA has
been a top priority for UK industry over the last couple of years. Our aim
has been to extend further in the online world the principles that are
already well established in our system, namely those of effective consumer
protection and fair competition."
[Ends]
[1] ASA adjudication against "Withinspiration", June 2010:
http://www.asa.org.uk/Complaints-an...ions/2010/6/Withinspiration/TF_ADJ_48612.aspx
[2] Background to this issue:
Advertising Standards Authority (ASA) Adjudication: Withinspiration (Lightning Process)
http://wp.me/p5foE-2Vt
A version of this post is published on ME agenda and Co-Cure:
Landmark agreement extends ASA's digital remit
It is of considerable public concern that Dr Esther Crawley has sought to obtain the advice, guidance and involvement of a Lightning Process practitioner who, in June, was subject to an Advertising Standards Authority (ASA) ruling in relation to claims being made in an advertisement about the efficacy of the Lightning Process for CFS and ME [1].
In July, I reported that Bournemouth Lightning Process instructor, Alastair Gibson, had already identified himself, on the "Withinspiration website", as "one of the two practitioners working with the NHS and the young people" in the Dr Crawley led pilot study into Lightning Process for children aged 8 to 18.
At 29 March, Mr Gibson's website had carried this information:
http://www.withinspiration.co.uk/index.php
"Breaking News - NHS and Lightning Process research collaboration.
"A new pilot study involving the Lightning Process and the NHS has been awarded 164,000 for research into the treatment of CFS/ME in children and adolescents. Alastair Gibson is one of the two practitioners working with the NHS and the young people in this exciting research study. Find out more."
That statement no longer appears on his website and it is unclear whether Mr Gibson retains an involvement with this proposed pilot study.
At 27 August, according to the University's FOI officer, the study had yet to obtain ethics approval. A research protocol and other information was supposed to have been published on the University of Bristol's website by the end of August - regardless of whether the study gained approval.
This material has failed to appear.
The Old Bailey Online site is a fully searchable collection of 197,745 criminal trials held at London's central criminal court:
In the 1700s, Old Bailey court reports included advertisements and this one caught my eye:
Old Bailey Proceedings, 27th February 1712:
"All Melancholy, Hysterical and Hypochondriacal Distempers, which variously
affect the Mind with strange Fears, and dismal Apprehensions, Paintings,
and Sinkings of the Spirits, great Hurries, Restlesness and Disquietment
(little understood, and seldom cured by any common Means) also Pains and
Giddiness of the Head, Risings to the Throat, Sick-fits, Tremblings,
Oppressions of the Heart, or any other Disorders caus'd by Vapours, are
successfully cured (with God's Blessing) by a Physician well experienc'd
therein, and of more than 20 Years Practice in those deplorable Cases; who
also cures all kind of Fits, tho' strange and violent, if curable; which he
informs on sight of their Water. Living next door to Shadwell Coffee-House
in Upper-Shadwell, near London; where those that have occasion, and live
remote, may direct their Letters, and they shall be speedily answer'd, or
attended on, if desired."
Well little changes, because in 2010, the sites of some Lightning Process practitioners are still making the following claims:
"What does it work for?
"People using the Lightning Process have also recovered from, or
experienced significant improvement with the following conditions: -
"Fibromyalgia
Chronic Fatigue Syndrome
Post Viral Fatigue
Asthma
Rheumatoid Arthritis
Hayfever
Depression
Dyspraxia
Bipolar Disorder
Ocd
Anxiety And Panic Attacks
Insomnia
Cerebral Palsy
Low Self Esteem
Parkinsons Tremors
Motor Neurone Disease
Hyper And Hypo Thyroidism
Chronic Aches And Pains
Ibs
Lyme Disease
Anger Issues
Food Intolerances
Coeliac Disease
Ptsd
Candida
Allergies
Type 2 Diabetes
Interstitial Cystitis
Migraines
Noise And Light Sensitivity
And Many More
"Using the Lightning Process has proven effective for clearing ALL the
debilitating physical and mind based symptoms of ME, chronic fatigue
syndrome, and post viral syndrome.
"Some of the symptoms that people have cleared are listed here...
"Addictions, adrenal problems, allergies and intolerances, anxiety, balance
problems, bloating, blurry vision, brain fog, candida, chemical
sensitivity, compulsive behaviours, concentration problems, confusion,
constipation, depression, diarrhoea, dizziness, electrical pulsing
sensations, excessive sleeping, exhaustion, fatigue, fear, feeling detached
or disconnected, fever and chills, flu-like symptoms, frequent coughs and
colds, fybromyalgia, hallucinations, head pain or pressure, heartburn,
indigestion, insomnia and other sleep disturbances, irritability, irritable
bowel syndrome, itching and rashes, itchy eyes, joint pain, light
sensitivity, loss of vision, malaise, memory loss, migraines, muscle pain,
nausea, noise sensitivity, oedema, panic attacks, painful and/or swollen
glands, pins and needles, restless leg syndrome, runny nose, sensitivity to
electrical fields/computers/mobiles etc, shaking, shooting pains, skin
sensitivity, stomach pain, sun burn sensation, swelling, temperature
control problems, thrush, thyroid problems, unrefreshing sleep, vertigo and
similar sensations, vomiting, water retention, watering eyes,
weakness.....and probably many more
"We advise you to consult your GP, have the necessary tests and obtain a
diagnosis before applying for the Lightning Process training programme"
The Phil Parker Lightning Process website and the sites of some Lightning Process practitioners have a "FAQ" page which includes the following:
"Can my doctor assess me for readiness?
"If your doctor or health care specialist is trained as a Lightning Process
Practitioner then of course they can assess you for readiness to take the
programme. If they are not trained in the programme they will not have the
requisite skills or knowledge base about this very specialised field to
assess you.
"A large part of the training for LP practitioners is to train them to
appropriately assess potential trainees for their suitability for the
process, as it is essential to ensure, as far as is possible, that only
those who are ready to get benefits from the training program are enrolled
in the training."
So, according to Mr Parker, your doctor is not capable of assessing patients for "readiness" to undertake the Lightning Process.
How and by whom are the potential child participants in the RNHRD NHS FT Bath/University of Bristol pilot study going to be assessed for "readiness" and suitability to undertake the "training"?
We don't know, because the University of Bristol is withholding virtually all information requested by me under Clause 22(1)(a) of the FOI Act.
Currently, the Advertising Standards Authority's remit does not extend to website content. But this is to change in March 2011.
The Advertising Standards Authority has issued this news release today:
http://asa.org.uk/Media-Centre/2010/ASA-digital-remit-extension.aspx
1 September 2010
The digital remit of the Advertising Standards Authority (ASA) is to be
extended significantly to deliver more comprehensive consumer protection
online.
The ASA's present remit online includes ads in paid-for space and sales
promotions wherever they appear. But from next year, the rules in the UK
Code of Non-broadcast Advertising, Sales Promotion and Direct Marketing
(the CAP Code) will apply in full to marketing communications online,
including the rules relating to misleading advertising, social
responsibility and the protection of children. The remit will apply to all
sectors and all businesses and organisations regardless of size.
The Committee of Advertising Practice (CAP), the body responsible for
writing the CAP Code, has decided to extend the digital remit of the ASA in
response to a formal recommendation from a wide cross-section of UK
industry. CAP has today published a document detailing the new remit and
sanctions.
http://asa.org.uk/Media-Centre/2010/~/media/Files/CAP/Codes/CAP Digital Remit Extension.ashx
In summary:
The new remit will ensure the same high standards as in other media and
will cover:
. Advertisers' own marketing communications on their own websites and;
. Marketing communications in other non-paid-for space under their
control, such as social networking sites like Facebook and Twitter.
Journalistic and editorial content and material related to causes and
ideas - except those that are direct solicitations of donations for
fund-raising - are excluded from the remit.
Sanctions
In addition to the ASA's present sanctions, which already achieve a high
level of compliance, CAP member bodies have agreed new sanctions to apply
to the extended remit such as:
. Removal of paid-for search advertising - ads that link to the page
hosting the non-compliant marketing communication may be removed with the
agreement of the search engines.
. ASA paid-for search advertisements - the ASA could place
advertisements online highlighting an advertiser?s continued
non-compliance.
Funding
The industry has agreed to apply the standard 0.1% levy on paid-for
advertisements appearing on internet search engines through media and
search agencies. This is an extension of the existing funding mechanism in
other media that pays for the ASA and it will be supplemented initially
with seed capital from Google.
Implementation
The remit will come into force on 1 March 2011 after a six month period of
grace to allow the ASA and CAP to conduct training work to raise awareness
and educate business on the requirements of the CAP Code, particularly
amongst those who may not previously have been subject to ASA regulation.
Website owners and agencies are urged to sign up to CAP Services to receive
guidance and training to help ensure their sites comply with the new rules
before 1 March 2011. ( http://bcap.org.uk/CAPServices.aspx )
ASA Chairman Lord Chris Smith said, "This significant extension of the
ASA's remit has the protection of children and consumers at its heart. We
have received over 4,500 complaints since 2008 about marketing
communications on websites that we couldn?t deal with, but from 1 March
anyone who has a concern about a marketing communication online will be
able to turn to the ASA."
CAP Chairman Andrew Brown said, "Extending the online remit of the ASA has
been a top priority for UK industry over the last couple of years. Our aim
has been to extend further in the online world the principles that are
already well established in our system, namely those of effective consumer
protection and fair competition."
[Ends]
[1] ASA adjudication against "Withinspiration", June 2010:
http://www.asa.org.uk/Complaints-an...ions/2010/6/Withinspiration/TF_ADJ_48612.aspx
[2] Background to this issue:
Advertising Standards Authority (ASA) Adjudication: Withinspiration (Lightning Process)
http://wp.me/p5foE-2Vt
Ecoclimber
Senior Member
- Messages
- 1,011
This is more crap from the psycho-babble community. It's a throw back to the dark ages. Where are the clinical trials? Where are the peer review research articles? Nada nothing. ME/CFS has a pathogenic origin that can't be healed or cure with mind over matter. Why don't they try their program with AIDS patients first? This is a another form or reincarnation of Mary Baker Eddy's Christian Science of mind over matter! It's a total waste of money that could be used to discover the pathogens associated with ME/CFS.
Yup. How foolish they will look, no different than supporting psycho-babble for HIV.
They don't care though, cash in the back of their pockets and plenty of more where that came from.
Blaming a person infected with MULV's is far cheaper than acknowledging one has infected the world with Mouse AIDS.
They don't care though, cash in the back of their pockets and plenty of more where that came from.
Blaming a person infected with MULV's is far cheaper than acknowledging one has infected the world with Mouse AIDS.
Hope123
Senior Member
- Messages
- 1,266
I haven't been following this thread so perhaps someone can fill me in on this is it was on the prior 33 pages.
I don't what rules research projects have to follow in the UK but I imagine that there probably are some similarities to the US. In the US, proposed projects have to undergo review from a board called the Institutional Review Board (IRBs, which can be based in hospitals, universities, etc.) that exists for the protection of study subjects. IRBs often follow US federal rules governing research; these rules ultimately are derived from Geneva/ Helsinki international human rights rules that were instituted partly because of Nazis experiments on Holocaust victims (Nuremberg Code). Part of what IRBs require from researchers is a signed voluntary consent form from research participants that has details about the proposed project including any benefits/ any potential risks (down to bruising/ pain from a blood draw!) , how to contact the researchers for questions/ problems, a statement that the subject may freely withdraw anytime from the project without penalty of any sort, etc. A further extension protecting children/ mentally underdeveloped subjects is that the parent or guardian must sign the form and not the child.
In regards to this LP study, I would ask if a consent form has been constructed and what that consent form contains as you could contest it to an ethics committee on the above points. If anyone has a copy of the consent form, that would also be interesting to see.
On IRBs: http://en.wikipedia.org/wiki/Institutional_review_board
On research ethics: http://en.wikipedia.org/wiki/Nuremberg_Code
On US research involving kids: http://www.hhs.gov/ohrp/researchfaq.html
This looks like one resource to go to in the UK: http://www.nres.npsa.nhs.uk/contacts/raising-concerns/
I don't what rules research projects have to follow in the UK but I imagine that there probably are some similarities to the US. In the US, proposed projects have to undergo review from a board called the Institutional Review Board (IRBs, which can be based in hospitals, universities, etc.) that exists for the protection of study subjects. IRBs often follow US federal rules governing research; these rules ultimately are derived from Geneva/ Helsinki international human rights rules that were instituted partly because of Nazis experiments on Holocaust victims (Nuremberg Code). Part of what IRBs require from researchers is a signed voluntary consent form from research participants that has details about the proposed project including any benefits/ any potential risks (down to bruising/ pain from a blood draw!) , how to contact the researchers for questions/ problems, a statement that the subject may freely withdraw anytime from the project without penalty of any sort, etc. A further extension protecting children/ mentally underdeveloped subjects is that the parent or guardian must sign the form and not the child.
In regards to this LP study, I would ask if a consent form has been constructed and what that consent form contains as you could contest it to an ethics committee on the above points. If anyone has a copy of the consent form, that would also be interesting to see.
On IRBs: http://en.wikipedia.org/wiki/Institutional_review_board
On research ethics: http://en.wikipedia.org/wiki/Nuremberg_Code
On US research involving kids: http://www.hhs.gov/ohrp/researchfaq.html
This looks like one resource to go to in the UK: http://www.nres.npsa.nhs.uk/contacts/raising-concerns/
Dx Revision Watch
Suzy Chapman Owner of Dx Revision Watch
- Messages
- 3,061
- Location
- UK
Hope123,
All your questions are covered by previous posts. The study is waiting on ethics approval by a South West Region Research Ethics Committee.
The REC met on 8 July.
The research protocol and other information relating to the study was expected to be published on the University of Bristol website last week.
Information requested by me under FOI and responses are set out in this post:
http://www.forums.aboutmecfs.org/sh...tudy-on-Children&p=93395&viewfull=1#post93395
Further response to an FOI request for information here:
http://www.forums.aboutmecfs.org/sh...dy-on-Children&p=117148&viewfull=1#post117148
I shall be speaking to the FOI office early this week for an update on the ethics committee decision and on the publication of the research protocol and other material.
As you'll see from the links above, a copy of the consent form was requested on 16 May. Virtually all information is being withheld under Clause 22(1)(a). I requested an internal review.
It is unlikely that all the information I have requested will be published and I shall therefore need to submit a further request once some information has been published or go to the Appeals process.
That is for applicants submitting studies for approval not for the public. There is no formal mechanism for challenging a decison.
Suzy
Dx Revision Watch
Suzy Chapman Owner of Dx Revision Watch
- Messages
- 3,061
- Location
- UK
Update @ 6 September
Still no research protocol published on the U of Bristol website.
(Dr Crawley had given the U of B assurance that the material would be published by the end of August, according the U of B Director of Legal Services.)
On Monday, an enquiry to the U of B FOI office returned the response:
that the study is still at the final stage of the ethics procedure;
that I would be sent the URL as soon as the information is available online.
And so it drags on. The REC had met to review the application for approval on 8 July. It is now nearly 2 months since the committee met.
According to NRECS documents, a decision can be expected within 10 days of a meeting.
So why the delay?
The funders have stipulated that the study must start by October 2010.
See this NRES document for which types of study require approval and which do not:
Training pack for applicants: http://meagenda.files.wordpress.com/2010/08/training-pack.pdf
Application workflow chart: http://meagenda.files.wordpress.com/2010/08/apply_flowchart1.pdf
Still no research protocol published on the U of Bristol website.
(Dr Crawley had given the U of B assurance that the material would be published by the end of August, according the U of B Director of Legal Services.)
On Monday, an enquiry to the U of B FOI office returned the response:
that the study is still at the final stage of the ethics procedure;
that I would be sent the URL as soon as the information is available online.
And so it drags on. The REC had met to review the application for approval on 8 July. It is now nearly 2 months since the committee met.
According to NRECS documents, a decision can be expected within 10 days of a meeting.
So why the delay?
The funders have stipulated that the study must start by October 2010.
See this NRES document for which types of study require approval and which do not:
Training pack for applicants: http://meagenda.files.wordpress.com/2010/08/training-pack.pdf
Application workflow chart: http://meagenda.files.wordpress.com/2010/08/apply_flowchart1.pdf
Dx Revision Watch
Suzy Chapman Owner of Dx Revision Watch
- Messages
- 3,061
- Location
- UK
An open AGM and some questions for Action for M.E. (Lightning Process)
7 September 2010
Shortlink to commentary by Suzy Chapman for ME agenda: http://wp.me/p5foE-36C
On Page 4 of the current issue of Action for M.E.’s InterAction magazine, CEO, Sir Peter Spencer, announces changes to the way in which the organisation operates.
Sir Peter writes, “In another significant change, inspired by your Board wishing to create greater transparency and demonstrate their accountability, our Trustees have voted to invite members to attend Action for M.E.’s annual general meeting (AGM). The first opportunity is Thursday 21 October in London and an application form for attendance is enclosed with this magazine.
“Additionally, the Board will be introducing procedures that will give all our Supporting Members voting rights regarding the appointment of Trustees and the Chair from 2011.”
How this change of policy will operate in practice remains to be seen but I would like to thank those who have lobbied long and hard for years for the right to attend AGMs, for voting rights and the right to participate in what I hope will be a democratic trustee election process.
I maintain a membership of Action for M.E. not because I support their policies or the way in which they operate but because, as a site owner, I need to know what the organisation is involving itself in and with whom, and what its policies and positions are.
There will be a question and answer session with the board members (the Trustees/Directors) at the AGM.
Were I to attend this first open AGM, scheduled for October, I would want to raise the following:
There has been considerable opposition to the Lightning Process pilot study for children aged 8 to 18 proposed by the Royal National Hospital for Rheumatic Diseases NHS Foundation Trust, Bath (the “Min”) and the University of Bristol.
This pilot study, led by Dr Esther Crawley, with funding from the Linbury Trust and the Ashden Trust, is still pending approval by a South West Region Research Ethics Committee.
The application was submitted on 14 June. The REC meeting to consider the application took place on 8 July.
Although funding for the study had been secured last November and a press release published in early March, at 6 September, the study is said to be “still at the final stage of the ethics procedure”.
The ME Association and the Young ME Sufferers Trust issued a joint press release on 4 August calling the proposed study “unethical” and for it to be abandoned.
To date, no rigorous controlled trials have been undertaken using an adult patient cohort into the safety, acceptability, long and short-term effects of the application of the Lightning Process.
No rationale has been provided by the research team for piloting first with children and there has been virtually no information made available about the study design, objectives, interventions, criteria, recruitment process etc, for public scrutiny.
At the end of March, in response to a request for a position statement, Action for M.E. said it saw “no reason to oppose this pilot study.”
On 24 August, in response to a request that Action for M.E. set out what information it had used to inform its position on whether to support this study and what its understanding is of what the children in this proposed study would be exposed to, Sir Peter wrote:
They don’t know. They’ve bought into a pig in a poke.
Four days earlier, Action for M.E. had issued a second position statement in which the organisation wrote:
But how much does this South West Region REC actually know about the Lightning Process?
What information have the researchers placed before this committee?
With no robust data from RCTs into the application of Lightning Process in adults, how is the research team and the Research Ethics Committee considering this application in a position to determine that overall the likely benefits of this proposal outweigh any risks to child participants or that undergoing the training program would not be detrimental to their health and psychological well-being, as patients with ME and CFS?
So I should want to ask how Action for M.E. justifies sidestepping responsibility for safeguarding children as young as eight under these circumstances?
I’d also raise the following:
On page 14 of this Autumn edition of InterAction, is a quarter page advertisement for the Phil Parker Lightning Process at the “Swallows Retreat”, in Henfield.
On page 32, a quarter page ad for the “Rowan Centre” who until recently, had been claiming on their website:
Their advertisement reads “We offer a training programme with on-going support to help people improve their symptoms. The teaching is based on neuroscience and cell biology and shows you how to affect your immune system using techniques derived from NLP processes, brain rehearsal and brief meditation techniques.”
On page 22, a half page ad for The Lightning Process with Alastair Gibson.
In June, Mr Gibson’s “Withinspiration” Lightning Process company had been subject to an Advertising Standards Authority adjudication following a complaint about unsubstantiated claims [1].
In March, Mr Gibson, who in September will be offering Lightning Process sessions in Bristol, had identified himself on his website as “…one of the two practitioners working with the NHS and the young people in this exciting research study”.
I am sure there will be many questions raised at this Action for M.E. open AGM next month.
I append a copy of the article “New benefits for our members” by Sir Peter Spencer.
[1] ASA adjudication against “Withinspiration”, June 2010:
http://www.asa.org.uk/Complaints-an...ions/2010/6/Withinspiration/TF_ADJ_48612.aspx
[2] Background to this Lightning Process pilot issue: http://wp.me/p5foE-2Vt
———————–
InterAction 73 Autumn 2010
New benefits for our members
Action for M.E. is transforming how it operates so that we can reach more people with M.E. and work more effectively on your behalf. Sir Peter Spencer explains.
We really do appreciate the expertise that people with M.E. share with us. Over the past three years we have greatly increased our efforts to consult so that we can better represent your views on a wide range of important matters. However, Action for M.E. can still do more to empower members to become an even stronger collective catalyst for change.
Today, the most efficient and cost-effective way of reaching more people with M.E. is through the internet. That’s why we are creating an entirely new website, the Online M.E. Centre.
As well as multi-media communication channels, new members-only forums will be available as safe havens, where people with M.E. can reach others who understand exactly what they’re going through. We know that 50% of people with M.E. are not in contact with anyone else with the illness. We have ample evidence that putting people in touch can really help them face and share the distressing problems of isolation caused by loss of social contact and not being understood by family and friends.
Membership
From September this year, anyone renewing or joining Action for M.E. for the first time will be able to choose the features and benefits they want from their membership package. You can join or renew online, by telephone or by post.
There will also be greater flexibility by giving members a personal choice about how much they feel able to contribute through their membership donation, either by a monthly direct debit or on an annual or lifelong basis. Exceptionally, those facing extreme financial hardship may be eligible for a payment waiver. The sustainability of our new membership arrangements will be made possible through the generosity of those more fortunate who are willing to give more to enable the most vulnerable to remain part of our movement; an essential point that I want to re-emphasise.
We greatly value you as members mainly for your presence and for contributing your expertise and moral support. You are much more than a vital source of revenue. The higher our numbers grow, the stronger our voice and the greater our credibility and authority in lobbying the Government for action.
Some of our supporters do not have M.E. themselves. Many of these provide extremely generous financial donations and free expertise because they care so much about those who have the illness. We need much larger numbers of all types of member and, because all members are essentially supporting our charity, we’ve adopted the term ‘Supporting Member’ to describe all categories of personal membership. Professional membership for individuals and organisations will also be available, allowing better access to relevant information about how to support people with M.E.
AGM and trustees
In another significant change, inspired by your Board wishing to create greater transparency and demonstrate their accountability, our Trustees have voted to invite members to attend Action for M.E.’s annual general meeting (AGM). The first opportunity is Thursday 21 October in London and an application form for attendance is enclosed with this magazine.
Additionally, the Board will be introducing procedures that will give all our Supporting Members voting rights regarding the appointment of Trustees and the Chair from 2011.
This is a crucial and exciting year for Action for M.E. I hope you agree that the developments I’ve described will ensure that we continue to meet your high expectations.
I know that many people with M.E. do not use the internet. So want to reassure you: Action for M.E. will of course continue to provide printed information through InterAction and our information booklets. We will also be providing enhanced telephone support line services from October.
Source: InterAction 73 Autumn 2010 http://www.afme.org.uk
7 September 2010
Shortlink to commentary by Suzy Chapman for ME agenda: http://wp.me/p5foE-36C
On Page 4 of the current issue of Action for M.E.’s InterAction magazine, CEO, Sir Peter Spencer, announces changes to the way in which the organisation operates.
Sir Peter writes, “In another significant change, inspired by your Board wishing to create greater transparency and demonstrate their accountability, our Trustees have voted to invite members to attend Action for M.E.’s annual general meeting (AGM). The first opportunity is Thursday 21 October in London and an application form for attendance is enclosed with this magazine.
“Additionally, the Board will be introducing procedures that will give all our Supporting Members voting rights regarding the appointment of Trustees and the Chair from 2011.”
How this change of policy will operate in practice remains to be seen but I would like to thank those who have lobbied long and hard for years for the right to attend AGMs, for voting rights and the right to participate in what I hope will be a democratic trustee election process.
I maintain a membership of Action for M.E. not because I support their policies or the way in which they operate but because, as a site owner, I need to know what the organisation is involving itself in and with whom, and what its policies and positions are.
There will be a question and answer session with the board members (the Trustees/Directors) at the AGM.
Were I to attend this first open AGM, scheduled for October, I would want to raise the following:
There has been considerable opposition to the Lightning Process pilot study for children aged 8 to 18 proposed by the Royal National Hospital for Rheumatic Diseases NHS Foundation Trust, Bath (the “Min”) and the University of Bristol.
This pilot study, led by Dr Esther Crawley, with funding from the Linbury Trust and the Ashden Trust, is still pending approval by a South West Region Research Ethics Committee.
The application was submitted on 14 June. The REC meeting to consider the application took place on 8 July.
Although funding for the study had been secured last November and a press release published in early March, at 6 September, the study is said to be “still at the final stage of the ethics procedure”.
The ME Association and the Young ME Sufferers Trust issued a joint press release on 4 August calling the proposed study “unethical” and for it to be abandoned.
To date, no rigorous controlled trials have been undertaken using an adult patient cohort into the safety, acceptability, long and short-term effects of the application of the Lightning Process.
No rationale has been provided by the research team for piloting first with children and there has been virtually no information made available about the study design, objectives, interventions, criteria, recruitment process etc, for public scrutiny.
At the end of March, in response to a request for a position statement, Action for M.E. said it saw “no reason to oppose this pilot study.”
On 24 August, in response to a request that Action for M.E. set out what information it had used to inform its position on whether to support this study and what its understanding is of what the children in this proposed study would be exposed to, Sir Peter wrote:
“…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.”
They don’t know. They’ve bought into a pig in a poke.
Four days earlier, Action for M.E. had issued a second position statement in which the organisation wrote:
“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.”
But how much does this South West Region REC actually know about the Lightning Process?
What information have the researchers placed before this committee?
With no robust data from RCTs into the application of Lightning Process in adults, how is the research team and the Research Ethics Committee considering this application in a position to determine that overall the likely benefits of this proposal outweigh any risks to child participants or that undergoing the training program would not be detrimental to their health and psychological well-being, as patients with ME and CFS?
So I should want to ask how Action for M.E. justifies sidestepping responsibility for safeguarding children as young as eight under these circumstances?
I’d also raise the following:
On page 14 of this Autumn edition of InterAction, is a quarter page advertisement for the Phil Parker Lightning Process at the “Swallows Retreat”, in Henfield.
On page 32, a quarter page ad for the “Rowan Centre” who until recently, had been claiming on their website:
“People using the Lightning Process have recovered from, or experienced significant improvement with the following issues and conditions
“ME, chronic fatigue syndrome, PVFS, adrenal fatigue, acute and chronic pain, back pain, fibromyalgia, rheumatoid arthritis, migraine, injury, PMT, perimenopausal symptoms and menopause, clinical depression, bipolar disorder, anxiety and panic attacks, OCD and PTSD, low self-esteem, confidence issues, hay fever, asthma and allergies, candida, interstitial cystitis, urinary infections, bladder and bowel, problems, IBS, coeliac disease, crohns disease, food intolerances and allergies, blood pressure, cardiac arrhythmia, type 2 diabetes, restless leg syndrome, hyper/hypo thyroidism, insomnia and sleep disorders, autistic spectrum disorder, dyspraxia, ADHD, lymes disease, glandular fever, epstein barr virus, weight and food issues, anorexia and eating disorders, multiple sclerosis, cerebral palsy, parkinsonian tremor, motor neurone disease”
“ME, chronic fatigue syndrome, PVFS, adrenal fatigue, acute and chronic pain, back pain, fibromyalgia, rheumatoid arthritis, migraine, injury, PMT, perimenopausal symptoms and menopause, clinical depression, bipolar disorder, anxiety and panic attacks, OCD and PTSD, low self-esteem, confidence issues, hay fever, asthma and allergies, candida, interstitial cystitis, urinary infections, bladder and bowel, problems, IBS, coeliac disease, crohns disease, food intolerances and allergies, blood pressure, cardiac arrhythmia, type 2 diabetes, restless leg syndrome, hyper/hypo thyroidism, insomnia and sleep disorders, autistic spectrum disorder, dyspraxia, ADHD, lymes disease, glandular fever, epstein barr virus, weight and food issues, anorexia and eating disorders, multiple sclerosis, cerebral palsy, parkinsonian tremor, motor neurone disease”
Their advertisement reads “We offer a training programme with on-going support to help people improve their symptoms. The teaching is based on neuroscience and cell biology and shows you how to affect your immune system using techniques derived from NLP processes, brain rehearsal and brief meditation techniques.”
On page 22, a half page ad for The Lightning Process with Alastair Gibson.
In June, Mr Gibson’s “Withinspiration” Lightning Process company had been subject to an Advertising Standards Authority adjudication following a complaint about unsubstantiated claims [1].
In March, Mr Gibson, who in September will be offering Lightning Process sessions in Bristol, had identified himself on his website as “…one of the two practitioners working with the NHS and the young people in this exciting research study”.
I am sure there will be many questions raised at this Action for M.E. open AGM next month.
I append a copy of the article “New benefits for our members” by Sir Peter Spencer.
[1] ASA adjudication against “Withinspiration”, June 2010:
http://www.asa.org.uk/Complaints-an...ions/2010/6/Withinspiration/TF_ADJ_48612.aspx
[2] Background to this Lightning Process pilot issue: http://wp.me/p5foE-2Vt
———————–
InterAction 73 Autumn 2010
New benefits for our members
Action for M.E. is transforming how it operates so that we can reach more people with M.E. and work more effectively on your behalf. Sir Peter Spencer explains.
We really do appreciate the expertise that people with M.E. share with us. Over the past three years we have greatly increased our efforts to consult so that we can better represent your views on a wide range of important matters. However, Action for M.E. can still do more to empower members to become an even stronger collective catalyst for change.
Today, the most efficient and cost-effective way of reaching more people with M.E. is through the internet. That’s why we are creating an entirely new website, the Online M.E. Centre.
As well as multi-media communication channels, new members-only forums will be available as safe havens, where people with M.E. can reach others who understand exactly what they’re going through. We know that 50% of people with M.E. are not in contact with anyone else with the illness. We have ample evidence that putting people in touch can really help them face and share the distressing problems of isolation caused by loss of social contact and not being understood by family and friends.
Membership
From September this year, anyone renewing or joining Action for M.E. for the first time will be able to choose the features and benefits they want from their membership package. You can join or renew online, by telephone or by post.
There will also be greater flexibility by giving members a personal choice about how much they feel able to contribute through their membership donation, either by a monthly direct debit or on an annual or lifelong basis. Exceptionally, those facing extreme financial hardship may be eligible for a payment waiver. The sustainability of our new membership arrangements will be made possible through the generosity of those more fortunate who are willing to give more to enable the most vulnerable to remain part of our movement; an essential point that I want to re-emphasise.
We greatly value you as members mainly for your presence and for contributing your expertise and moral support. You are much more than a vital source of revenue. The higher our numbers grow, the stronger our voice and the greater our credibility and authority in lobbying the Government for action.
Some of our supporters do not have M.E. themselves. Many of these provide extremely generous financial donations and free expertise because they care so much about those who have the illness. We need much larger numbers of all types of member and, because all members are essentially supporting our charity, we’ve adopted the term ‘Supporting Member’ to describe all categories of personal membership. Professional membership for individuals and organisations will also be available, allowing better access to relevant information about how to support people with M.E.
AGM and trustees
In another significant change, inspired by your Board wishing to create greater transparency and demonstrate their accountability, our Trustees have voted to invite members to attend Action for M.E.’s annual general meeting (AGM). The first opportunity is Thursday 21 October in London and an application form for attendance is enclosed with this magazine.
Additionally, the Board will be introducing procedures that will give all our Supporting Members voting rights regarding the appointment of Trustees and the Chair from 2011.
This is a crucial and exciting year for Action for M.E. I hope you agree that the developments I’ve described will ensure that we continue to meet your high expectations.
I know that many people with M.E. do not use the internet. So want to reassure you: Action for M.E. will of course continue to provide printed information through InterAction and our information booklets. We will also be providing enhanced telephone support line services from October.
Source: InterAction 73 Autumn 2010 http://www.afme.org.uk
Dx Revision Watch
Suzy Chapman Owner of Dx Revision Watch
- Messages
- 3,061
- Location
- UK
Response from Dr Esther Crawley
Although it has been reported that Dr Crawley is not responding to approaches, one person at least has received a recent response.
The following was posted on The ME Association's Facebook Wall, yesterday:
--------------------------
"Dear Mrs *****
Thank you for your email. I am very sorry to hear about your daughter.
I agree that in children CFS/ME is almost always triggered by a virus. We know it is genetically heritable and there is good evidence for different phenotypes of illness. We have published to show that children are very disabled and this is not because of mood disorders.
Thank you for sharing with me your concern about this planned study. We are doing the study because so many young people and their parents have asked us about the Lightning Process and have asked us to do this research. Many have gone on to try the Lightning Process without any scientific evidence on whether it works or not. We do not know whether research is possible and this study will find out whether it is. All the information on the study will be published on the web shortly and I suspect this will answer the concerns that have been raised about it. This study does not detract from all the other work I do to find out the cause of this debilitating illness."
-------------------
This sounds to me like a woman who is confident that REC approval is already in the bag.
As soon as I have heard from the U of Bristol FOI office with a URL for the research protocol and other information, I will update.
Suzy
Although it has been reported that Dr Crawley is not responding to approaches, one person at least has received a recent response.
The following was posted on The ME Association's Facebook Wall, yesterday:
--------------------------
"Dear Mrs *****
Thank you for your email. I am very sorry to hear about your daughter.
I agree that in children CFS/ME is almost always triggered by a virus. We know it is genetically heritable and there is good evidence for different phenotypes of illness. We have published to show that children are very disabled and this is not because of mood disorders.
Thank you for sharing with me your concern about this planned study. We are doing the study because so many young people and their parents have asked us about the Lightning Process and have asked us to do this research. Many have gone on to try the Lightning Process without any scientific evidence on whether it works or not. We do not know whether research is possible and this study will find out whether it is. All the information on the study will be published on the web shortly and I suspect this will answer the concerns that have been raised about it. This study does not detract from all the other work I do to find out the cause of this debilitating illness."
-------------------
This sounds to me like a woman who is confident that REC approval is already in the bag.
As soon as I have heard from the U of Bristol FOI office with a URL for the research protocol and other information, I will update.
Suzy
- Messages
- 80
- Location
- The Matrix
hi, haven't read the whole thread so my post maybe irrelevant.
the lightning process requires total and utter commitment and belief by the trainee for it to have even it's occasionbal slight improvement in symptons. i have spoke with folk who are still drastically ill, who still swear by it. point being that you cannot take a trainee's word of it's efficacy at face value, which makes a research study on it pretty much redundant. the positive assertion that it works is central to it, regardless of actual improvement. anyway research studies can prove or dis-prove anything depending on criteria, what data is made available, who conducts the trial, who is chosen to take part....not sure what the aim is either, is it to decide whether or not to make it available on the nhs? wouldn't be surprised if that happened as it's similar to c.b.t. and g.e.t. and puts the efficacy of the treatments onto whether or not the patients wants to recover rather than the credibilty of the approach itself...
the lightning process requires total and utter commitment and belief by the trainee for it to have even it's occasionbal slight improvement in symptons. i have spoke with folk who are still drastically ill, who still swear by it. point being that you cannot take a trainee's word of it's efficacy at face value, which makes a research study on it pretty much redundant. the positive assertion that it works is central to it, regardless of actual improvement. anyway research studies can prove or dis-prove anything depending on criteria, what data is made available, who conducts the trial, who is chosen to take part....not sure what the aim is either, is it to decide whether or not to make it available on the nhs? wouldn't be surprised if that happened as it's similar to c.b.t. and g.e.t. and puts the efficacy of the treatments onto whether or not the patients wants to recover rather than the credibilty of the approach itself...
Dx Revision Watch
Suzy Chapman Owner of Dx Revision Watch
- Messages
- 3,061
- Location
- UK
What little is currently known about the study design and methods for this pilot trial in children has been covered in this and other threads. The pilot is to find out whether it is possible to run a multi-centre RCT into the applcation of LP in children.
"Pilot project to investigate how to recruit to a randomised controlled trial looking at the Phil Parker Lightning Process and specialist medical care in CFS/ME in children. Project to incorporate study on health economic cost of CFS/ME in children."
The Press Release, University of Bristol, 2 March 2010 is here:
http://www.bristol.ac.uk/news/2010/6866.html
A media article here:
http://meagenda.files.wordpress.com...gue-syndrome-study-mineral-water-hospital.pdf
The research protocol is expected to be published online shortly and I will update the thread when I have notification from the University of Bristol FOI office that the protocol and other information is available.
Suzy
"Pilot project to investigate how to recruit to a randomised controlled trial looking at the Phil Parker Lightning Process and specialist medical care in CFS/ME in children. Project to incorporate study on health economic cost of CFS/ME in children."
The Press Release, University of Bristol, 2 March 2010 is here:
http://www.bristol.ac.uk/news/2010/6866.html
A media article here:
http://meagenda.files.wordpress.com...gue-syndrome-study-mineral-water-hospital.pdf
The research protocol is expected to be published online shortly and I will update the thread when I have notification from the University of Bristol FOI office that the protocol and other information is available.
Suzy
Thank you Suzy for keeping us up to date with this.
I am following the thread with interest as my 12 year old has ME/CFS (as do I) and I am appalled that this "study" may be approved .
With the news of the Dundee study into blood abnormalities in children with ME/CFS showing activating ongoing viral issues - I would much rather see the money being used to further this important piece of medical research.
You may have already answered this before - but who is it best to write to to add my concerns??
Thanks again
I am following the thread with interest as my 12 year old has ME/CFS (as do I) and I am appalled that this "study" may be approved .
With the news of the Dundee study into blood abnormalities in children with ME/CFS showing activating ongoing viral issues - I would much rather see the money being used to further this important piece of medical research.
You may have already answered this before - but who is it best to write to to add my concerns??
Thanks again
Genetically heritable
Her phenotypes were answers to questions at one moment in time. People's symptoms can change. They didn't prove much with that study from what I recall.
We don't have strong evidence it's genetically heritable. I don't think that would qualify as an "evidence-based" statement.
Her phenotypes were answers to questions at one moment in time. People's symptoms can change. They didn't prove much with that study from what I recall.
Hi,
I’m new to these forums, so I hope this works.
On 8th July I sent a letter to Dr. Esther Crawley regarding the proposed pilot study to look at how to recruit to a RCT of the Lightning Process on children. I have received no acknowledgement of the letter, nor any reply, despite a follow-up e-mail. I cc'd my letter to a number of the patient organisations (amongst other organisations). As of 12/8/10, I had received no reply from AYME, apart from an acknowledgement a few weeks before which said that their CEO was on annual leave, and that she would reply when she could; so, I e-mailed to ask if the CEO, Mary-Jane Willows, was back from annual leave. After many e-mails, and explanations, from AYME, I received a letter on 01/9/10.
The bottom of this letter reads:
PLEASE NOTE: This letter is a personal response and is not for reproducing or to be posted or quoted in the public domain.
However, I have decided to post about this letter on this thread is because I think it is in the public interest to know what AYME's views are towards the study, and as they have made no other statement, and are a national patient charity, I think others are entitled to know what they have expressed in their letter to me.
The letter is from the Grants and Projects Manager, pp Mary-Jane Willows. However 'I' is used several times throughout the letter, rather than 'we' or 'AYME', which I am concerned about, and I am writing to AYME about this, for further clarification.
Since the letter is pp Mary-Jane Willows, I shall presume that the use of 'I' refers to Mary-Jane Willows, and that 'we' refers to AYME.
*****Please could you kindly NOT RE POST*****
without permission from me. I'm worried that if people re post that it will end up with people thinking it is some kind of statement.
----------------------------------------------------
Mary-Jane agrees with many of my concerns about the Lightning Process; LP practitioners have been making bold claims about the effectiveness of the treatment for some time, without reliable clinical data to support them. It seems that children will continue to receive the treatment despite what concerned onlookers such as Mary-Jane and I tell them. Therefore, AYME have wanted research to be carried out so that young people can make an informed choice, and they welcome the proposal to investigate the possibility of carrying out clinical trials.
Mary-Jane takes very seriously my allegations that this would harm children and breach human rights, and so she keenly awaits the decision of the ethics panel; she believes that they will examine these points, including whether the research could feasibly be carried out on adults, and whether it would put participants at risk of harm.
Mary-Jane would also oppose the research if these were the case, but at the moment, she does not see grounds to doubt the good faith of the research team.
She thinks it is critically important that more objective and ethical research is carried out into M.E. in children, and that many researchers have been discouraged by extremely negative and hostile reactions from a small part of the M.E. community. She assures me that my letter in no way falls into this category, but hopes I will understand that AYME's position is to welcome quality research that can be shown to be impartial, thorough and ethical.
--------------------------------------------------------
I am also concerned about some of the rather vague and unspecific (or unclear) statements made in this letter, and I will also be replying to AYME for clarification of these too.
I apologise not to have posted this sooner; unfortunately my health has deteriorated recently and I have taken longer to write this up.
Best wishes,
Frances
I’m new to these forums, so I hope this works.
On 8th July I sent a letter to Dr. Esther Crawley regarding the proposed pilot study to look at how to recruit to a RCT of the Lightning Process on children. I have received no acknowledgement of the letter, nor any reply, despite a follow-up e-mail. I cc'd my letter to a number of the patient organisations (amongst other organisations). As of 12/8/10, I had received no reply from AYME, apart from an acknowledgement a few weeks before which said that their CEO was on annual leave, and that she would reply when she could; so, I e-mailed to ask if the CEO, Mary-Jane Willows, was back from annual leave. After many e-mails, and explanations, from AYME, I received a letter on 01/9/10.
The bottom of this letter reads:
PLEASE NOTE: This letter is a personal response and is not for reproducing or to be posted or quoted in the public domain.
However, I have decided to post about this letter on this thread is because I think it is in the public interest to know what AYME's views are towards the study, and as they have made no other statement, and are a national patient charity, I think others are entitled to know what they have expressed in their letter to me.
The letter is from the Grants and Projects Manager, pp Mary-Jane Willows. However 'I' is used several times throughout the letter, rather than 'we' or 'AYME', which I am concerned about, and I am writing to AYME about this, for further clarification.
Since the letter is pp Mary-Jane Willows, I shall presume that the use of 'I' refers to Mary-Jane Willows, and that 'we' refers to AYME.
*****Please could you kindly NOT RE POST*****
without permission from me. I'm worried that if people re post that it will end up with people thinking it is some kind of statement.
----------------------------------------------------
Mary-Jane agrees with many of my concerns about the Lightning Process; LP practitioners have been making bold claims about the effectiveness of the treatment for some time, without reliable clinical data to support them. It seems that children will continue to receive the treatment despite what concerned onlookers such as Mary-Jane and I tell them. Therefore, AYME have wanted research to be carried out so that young people can make an informed choice, and they welcome the proposal to investigate the possibility of carrying out clinical trials.
Mary-Jane takes very seriously my allegations that this would harm children and breach human rights, and so she keenly awaits the decision of the ethics panel; she believes that they will examine these points, including whether the research could feasibly be carried out on adults, and whether it would put participants at risk of harm.
Mary-Jane would also oppose the research if these were the case, but at the moment, she does not see grounds to doubt the good faith of the research team.
She thinks it is critically important that more objective and ethical research is carried out into M.E. in children, and that many researchers have been discouraged by extremely negative and hostile reactions from a small part of the M.E. community. She assures me that my letter in no way falls into this category, but hopes I will understand that AYME's position is to welcome quality research that can be shown to be impartial, thorough and ethical.
--------------------------------------------------------
I am also concerned about some of the rather vague and unspecific (or unclear) statements made in this letter, and I will also be replying to AYME for clarification of these too.
I apologise not to have posted this sooner; unfortunately my health has deteriorated recently and I have taken longer to write this up.
Best wishes,
Frances
Angela Kennedy
Senior Member
- Messages
- 1,026
- Location
- Essex, UK
Thanks for this Frances.
Wow. The old hostile and negative small part of the ME community red herring again? Who exactly are these recalcitrants?
Same old same old. Bit of handwringing - but let an unethical trial run anyway.
Next trial, cocaine to pep up the tired kids... well, AYME have wanted research to be carried out so that young people can make an informed choice, and they welcome proposals to investigate the possibility of carrying out clinical trials for therapies, even the more 'out there' ones...
(disclaimer - the last line is an attempt at satire, using analogy to place Willow's comments to a hypothetical logical extreme...)
Angela Kennedy
Senior Member
- Messages
- 1,026
- Location
- Essex, UK
And while we're at it, let's use another logical extreme. The CEO of the leading child cancer charity supports a trial of the Lightning process to cure cancer in children, despite her concerns.
Would that cause an uproar?