Lightning Process to be Evaluated in Research Study on Children

[Min]

The NSPCC have replied to my email outlining my concerns about this trial, and enclosing the TYMES Trust and MEA's original joint statement:

"Thank you for your email.

The NSPCC has a remit to prevent cruelty to children in the UK. We are not a
medical charity and are not able to comment on these tests. However, we do take
this matter seriously and will be contacting the University of Bristol to pass
on your concerns.

Regards
Duty Enquiries Officer
NSPCC Safeguarding Information & Library Service
Weston House
42 Curtain Rd
London EC2A 3NH "

so they will not actually do anything much

 

[Dx Revision Watch]

http://www.publications.parliament....d/cm101011/text/101011w0004.htm#1010122002138

House of Commons Written answers and statements

(Hansard Citation: HC Deb, 11 October 2010, c87W)


11 Oct 2010 : Column 87W

Health

Phil Parker Lightning Process

Written answers and statements, 11 October 2010

Annette Brooke (Mid Dorset and North Poole, Liberal Democrat)

To ask the Secretary of State for Health what representations he has
received on the research and development of the Phil Parker Lightning
Process.[15725]


Paul Burstow (Minister of State (Care Services), Health; Sutton and Cheam,
Liberal Democrat)

The Department has received representations, from individual members of the
public and on behalf of chronic fatigue syndrome/myalgic encephalomylitis
stakeholder groups, on research proposals associated with the Lightning
Process.

--------------------

Related material:

1] SMILE - Specialist Medical Intervention and Lightning Evaluation
documents (Lightning Process pilot study - children [now aged 12 to 18]
with CFS and ME): http://wp.me/p5foE-37x

2] ASA adjudication against "Withinspiration", June 2010:
http://www.asa.org.uk/Complaints-an...ions/2010/6/Withinspiration/TF_ADJ_48612.aspx

3] Background to this issue: http://wp.me/p5foE-2Vt

4] All posts on Lightning Process pilot study in children issue:
http://meagenda.wordpress.com/category/lightning-process-smile-study/

 

[kettles]

An article has been published in the Church Times concerning the Lightning Process and the trial on children.

Dr John Greensmith has archived it on his website:

http://tinyurl.com/2a5nwwy

The Church Times website requires you to subscribe in order to view it, but I understand that when the next edition comes out, it will go into the archive and become public.

 

[Angela Kennedy]

The NSPCC have replied to my email outlining my concerns about this trial, and enclosing the TYMES Trust and MEA's original joint statement:

"Thank you for your email.

The NSPCC has a remit to prevent cruelty to children in the UK. We are not a
medical charity and are not able to comment on these tests. However, we do take
this matter seriously and will be contacting the University of Bristol to pass
on your concerns.

Regards
Duty Enquiries Officer
NSPCC Safeguarding Information & Library Service
Weston House
42 Curtain Rd
London EC2A 3NH "

so they will not actually do anything much

Ah yes, prevent 'cruelty' to children. What does that even mean?

 

[Dx Revision Watch]

I made a Tiny URL for ME Free For All copy: http://tinyurl.com/Prof-Robin-Gill-LP-letter

Or read on the MEA's site: http://www.meassociation.org.uk/?p=2448


Children should not be used as guinea pigs

Church Times, 8 October 2010

BY: ROBIN GILL

Clinical trials of a training programme for ME, MS, and other conditions raise serious ethical questions, argues Robin Gill.

An impassioned online debate has arisen about the authorisation this summer of a scientifically controlled clinical trial of children by a consultant paediatrician linked to Bristol University. The trial plans to recruit children aged 12 to 18 with ME, or chronic fatigue syndrome (CFS), into a randomised controlled trial, comparing the effectiveness of the so-called Lightning Process with that of conventional medical care.

Critics argue that the Lightning Process is being promoted commercially for use across a wide range of medical conditions, even though it is as yet scientifically untested for its effectiveness or even safety, and that it should be tested on volunteer, competent adults long before it is tested on children. It is not, of course, for a theologian to pass any scientific judgement on the Lightning Process. At an ethical and theological level, however, it does raise issues that have arisen before in the context of commercially driven faith-healers. Morris Cerullos Mission to London in 1992 raised these issues in a sharp way, for example.

The Lightning Process was developed by the Phil Parker organisation, and involves a three-day course, said to be based upon neuro-linguistic programming (which is concerned with brain-body connections) and life coaching. This programming, or coaching, seeks to make your mind influence your condition in such a way as leads to improvements in the condition. The organisations website emphasises that the Lightning Process is thus neither a therapy nor a treatment, but a training programme (although clients on the site write about becoming well).

The website also claims that this programme can address a very wide range of conditions: ME/CFS, food/ chemical intolerances, depression, fibromyalgia/chronic pain, weight loss, phobias/anxiety/stress, multiple sclerosis, eating disorders, low self-esteem, irritable bowel syndrome/ digestive issues, obsessive-compulsive disorder, and other conditions.

The site runs a disclaimer: Due to the nature of the training we cannot guarantee results as everyone is different, however we have received a considerable amount of positive feedback from clients with chronic illness. Esther Rantzen, for instance, and her daughter (who has had ME) are both quoted giving such positive feedback.

Mr Cerullo also claimed to be able to address a wide variety of conditions. The advertising campaign for his Mission to London featured posters showing discarded white canes and overturned wheelchairs, and carried the caption (without any disclaimer): Some will see Miracles for the First Time.

After investigating complaints, the Advertising Standards Authority (ASA) concluded in October 1992 that the posters had been targeted on the disabled, and were a source of distress. Similarly, in June 2010, the ASA found against an advert carried by a Bournemouth company that they did not hold robust evidence to support their claims that the lightning process was an effective treatment for CFS or ME . . . we concluded that the claims had not been proven and were therefore misleading. Arguably, a number of the conditions listed on the Lightning Process website are psychosomatic, and might effectively be addressed by a cognitive training programme. It will be seen, though, that multiple sclerosis is included.

The MS Society remains cautious about this. It replies to enquirers that the claims of the Lightning Process in relation to MS are not currently backed up by scientific trial evidence, and that it is therefore unable to comment on its effectiveness and/or safety.

The MS Society has good reason to be cautious. In the past few days, a doctor has been struck off for exploiting MS patients, after claiming that he could cure them with injections of cow stem-cells. The chairman of the GMC disciplinary panel told him: You have exploited vulnerable patients. . . Your conduct has unquestionably done lasting harm.

Critics of the Lightning Process also argue that people (especially the young) who place hopes in the ability of the Lightning Process to improve their condition, and yet find no such improvement, can become more despondent, and feel worse than they were before. They may even stop taking vital medication.

Critics of Mr Cerullo claimed that that is exactly what happened, when a vulnerable person gave up life-sustaining medication and died soon after attending one of his healing services.

The word currently is important in the position of the MS Society. It implies that, if the claims of the Lightning Process were based on solid evidence, instead of anecdotes, then its advice could change. This is exactly why cognitive behavioural therapy, for example, has gradually become an accepted medical procedure.

As it happens, there is also a considerable body of reliable survey evidence (some of it resulting from large population studies) that religious beliefs and practices can be a significant factor in health and longevity (as can a happy marriage).

This is certainly not to say that the specific actions of Mr Cerullo would indeed have allowed people to See Miracles for the First Time. Nor is it to say that doctors should prescribe churchgoing or marriage to their ill patients (faith and marriage being emphatically both personal commitments, not forms of medication). But it is to say that strong personal commitments do seem to be a part of living healthily. Perhaps that is what the Lightning Process is trying to promote as well.

There is still a problem, however. Critics of the involvement of children in the Bristol ME/CFS clinical trial are surely correct. The GMC and BMA have both insisted for some time that clinical trials should always involve competent adults wherever possible. These adults should be fully informed, and must give their explicit and uncoerced consent. If they then decide to take part in a clinical trial, that is entirely up to them.

Children and incapacitated adults should be involved only when this is not possible (such as when the particular conditions apply only to them) and, even then, a proper assessment must be made that the clinical trial is genuinely in their best interests. The coercion of children is not an ethically acceptable option.

Canon Robin Gill is Professor of Applied Theology at the University of Kent.

e-mail adress for any letters in reply to this article: letters@churchtimes.co.uk

Copyright: The Church Times 2010

---------

Bio for Canon, Prof Robin Gill here: http://www.st-edmunds.cam.ac.uk/faraday/Biography.php?ID=156

"He is a member of the BMA Medical Ethics Committee and has been a member of the Medical Research Council's Stem Cell Steering Committee, President of the Society for the Study of Christian Ethics and Chair of British Sociological Association's Study Group of Religion."

 

[Angela Kennedy]

I made a Tiny URL for ME Free For All copy: http://tinyurl.com/Prof-Robin-Gill-LP-letter

Or read on the MEA's site: http://www.meassociation.org.uk/?p=2448


Children should not be used as guinea pigs

Church Times, 8 October 2010

BY: ROBIN GILL

Clinical trials of a training programme for ME, MS, and other conditions raise serious ethical questions, argues Robin Gill.

An impassioned online debate has arisen about the authorisation this summer of a scientifically controlled clinical trial of children by a consultant paediatrician linked to Bristol University. The trial plans to recruit children aged 12 to 18 with ME, or chronic fatigue syndrome (CFS), into a randomised controlled trial, comparing the effectiveness of the so-called Lightning Process with that of conventional medical care.

Critics argue that the Lightning Process is being promoted commercially for use across a wide range of medical conditions, even though it is as yet scientifically untested for its effectiveness or even safety, and that it should be tested on volunteer, competent adults long before it is tested on children. It is not, of course, for a theologian to pass any scientific judgement on the Lightning Process. At an ethical and theological level, however, it does raise issues that have arisen before in the context of commercially driven faith-healers. Morris Cerullo’s Mission to London in 1992 raised these issues in a sharp way, for example.

The Lightning Process was developed by the Phil Parker organisation, and involves a three-day course, said to be based upon neuro-linguistic programming (which is concerned with brain-body connections) and life coaching. This programming, or coaching, seeks to make your mind influence your condition in such a way as leads to improvements in the condition. The organisation’s website emphasises that the Lightning Process is thus neither a therapy nor a treatment, but a “training programme” (although clients on the site write about “becoming well”).

The website also claims that this programme can address a very wide range of conditions: ME/CFS, food/ chemical intolerances, depression, fibromyalgia/chronic pain, weight loss, phobias/anxiety/stress, multiple sclerosis, eating disorders, low self-esteem, irritable bowel syndrome/ digestive issues, obsessive-compulsive disorder, and “other conditions”.

The site runs a disclaimer: “Due to the nature of the training we cannot guarantee results as everyone is different, however we have received a considerable amount of positive feedback from clients with chronic illness.” Esther Rantzen, for instance, and her daughter (who has had ME) are both quoted giving such positive feedback.

Mr Cerullo also claimed to be able to address a wide variety of conditions. The advertising campaign for his Mission to London featured posters showing discarded white canes and overturned wheelchairs, and carried the caption (without any disclaimer): “Some will see Miracles for the First Time”.

After investigating complaints, the Advertising Standards Authority (ASA) concluded in October 1992 that the posters had been “targeted on the disabled”, and were “a source of distress”. Similarly, in June 2010, the ASA found against an advert carried by a Bournemouth company that they “did not hold robust evidence to support their claims that the lightning process was an effective treatment for CFS or ME . . . we concluded that the claims had not been proven and were therefore misleading.” Arguably, a number of the conditions listed on the Lightning Process website are psychosomatic, and might effectively be addressed by a cognitive training programme. It will be seen, though, that multiple sclerosis is included.

The MS Society remains cautious about this. It replies to enquirers that the claims of the Lightning Process in relation to MS are not currently backed up by scientific trial evidence, and that it is therefore unable to comment on its effectiveness and/or safety.

The MS Society has good reason to be cautious. In the past few days, a doctor has been struck off for exploiting MS patients, after claiming that he could cure them with injections of cow stem-cells. The chairman of the GMC disciplinary panel told him: “You have exploited vulnerable patients. . . Your conduct has unquestionably done lasting harm.”

Critics of the Lightning Process also argue that people (especially the young) who place hopes in the ability of the Lightning Process to improve their condition, and yet find no such improvement, can become more despondent, and feel worse than they were before. They may even stop taking vital medication.

Critics of Mr Cerullo claimed that that is exactly what happened, when a vulnerable person gave up life-sustaining medication and died soon after attending one of his healing services.

The word “currently” is important in the position of the MS Society. It implies that, if the claims of the Lightning Process were based on solid evidence, instead of anecdotes, then its advice could change. This is exactly why cognitive behavioural therapy, for example, has gradually become an accepted medical procedure.

As it happens, there is also a considerable body of reliable survey evidence (some of it resulting from large population studies) that religious beliefs and practices can be a significant factor in health and longevity (as can a happy marriage).

This is certainly not to say that the specific actions of Mr Cerullo would indeed have allowed people to “See Miracles for the First Time.” Nor is it to say that doctors should prescribe churchgoing or marriage to their ill patients (faith and marriage being emphatically both personal commitments, not forms of medication). But it is to say that strong personal commitments do seem to be a part of living healthily. Perhaps that is what the Lightning Process is trying to promote as well.

There is still a problem, however. Critics of the involvement of children in the Bristol ME/CFS clinical trial are surely correct. The GMC and BMA have both insisted for some time that clinical trials should always involve competent adults wherever possible. These adults should be fully informed, and must give their explicit and uncoerced consent. If they then decide to take part in a clinical trial, that is entirely up to them.

Children and incapacitated adults should be involved only when this is not possible (such as when the particular conditions apply only to them) — and, even then, a proper assessment must be made that the clinical trial is genuinely in their best interests. The coercion of children is not an ethically acceptable option.

Canon Robin Gill is Professor of Applied Theology at the University of Kent.

e-mail adress for any letters in reply to this article: letters@churchtimes.co.uk

Copyright: The Church Times 2010

---------

Bio for Canon, Prof Robin Gill here: http://www.st-edmunds.cam.ac.uk/faraday/Biography.php?ID=156

"He is a member of the BMA Medical Ethics Committee and has been a member of the Medical Research Council's Stem Cell Steering Committee, President of the Society for the Study of Christian Ethics and Chair of British Sociological Association's Study Group of Religion."

It's unfortunate that he hasn't made the connection between the LP and the principles of CBT for ME/CFS though. CBT works on a very similar belief system, and applying that to children is just as risky. For the ME/CFS child, it's a case of proposing they should jump out of the LP frying pan, and into the CBT fire.

 

[Dx Revision Watch]

The Prof Robin Gill letter in Church Times is now available from the archives of the Church Times site:

Issue 7699, 8 October 2010

http://www.churchtimes.co.uk/content.asp?id=101886

 

[kermit frogsquire]

Esther Crawley epitomises everything that is wrong about doctors treating ME - pictures are better than a thousand words as they say - see Crawley creep and crawl in the flesh -

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

Anyone and everyone that can, would do well to write a letter, see their MP, and demand that this trial be stopped. Please help get this trial stopped! Crawley is claiming that this trial can be done on children because

"CFS/ME in children has a different outcome to adults and the treatment is different therefore research in adults cannot be extrapolated to children."

Under the rules trials cannot normally be done on children unless there is no other option. But lightning process practitioners are claiming there is an 85% success rate in adults and that children respond equally well - so Dr Esther Crawleys statement is absolutely misleading in this instance.

Letters should go to the National Regional Ethics Service. Please help STOP this utter abomination of a study!

Joan Kirkbride
Head of Operations, England
National Research Ethics Service
National Patient Safety Agency
Darlington Primary Care Trust
Dr Piper House
King Street
Darlington
Co. Durham
DL3 6JL

 

[Dx Revision Watch]

For comment please refer to Posts #50 and #51 in this thread:

Dr Esther Crawley: Transcript of Presentation: The Future of Research in CFS/ME

Post 50

Post 51

 

[Dx Revision Watch]

Countess of Mar: Parliamentary Questions for Written Answer: Lightning Process pilot study ethical approval

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

In July, I had approached the Countess of Mar for her support in the Lightning Process pilot study issue. Unfortunately, Lady Mar's health at the time precluded her involvement.

On 21 October, Lady Mar tabled a Question for Written Answer and a response is due on 4 November.


http://www.publications.parliament.uk/pa/ld201011/minutes/101022/ldordpap.htm

House of Lords Business
Questions for Written Answer [House of Lords]

Tabled on 21 October and due for answer by 4 November.

[...]

The Countess of Mar 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. HL3014


Related material

Children should not be used as guinea pigs: Prof Robin Gill, Church Times (Lightning Process Pilot study): http://wp.me/p5foE-3ak

House of Commons: Written answers and statements: Phil Parker Lightning Process: http://wp.me/p5foE-39J

Hansard Citation: HC Deb, 11 October 2010, c87W

11 Oct 2010 : Column 87W

Health
Phil Parker Lightning Process

Written answers and statements, 11 October 2010

Annette Brooke [Mid Dorset and North Poole, Liberal Democrat]: To ask the Secretary of State for Health what representations he has received on the research and development of the Phil Parker Lightning Process.[15725]

Paul Burstow [Minister of State (Care Services), Health; Sutton and Cheam, Liberal Democrat]: The Department has received representations, from individual members of the public and on behalf of chronic fatigue syndrome/myalgic encephalomylitis stakeholder groups, on research proposals associated with the Lightning Process.

--------------

Annette Brooke, MP, is Vice-chair of the newly reformed APPG on ME and has been active in a number of Parliamentary Public Bill Committees (formerly known as "Standing Committees") representing the rights of children and families:

http://www.theyworkforyou.com/mp/annette_brooke/mid_dorset_and_north_poole


SMILE - Specialist Medical Intervention and Lightning Evaluation documents (Lightning Process pilot study - children [now aged 12 to 18] with CFS and ME): http://wp.me/p5foE-37x

Background to this issue on ME agenda site: http://wp.me/p5foE-2Vt

All posts on Lightning Process pilot study in children issue on ME agenda site:
http://meagenda.wordpress.com/category/lightning-process-smile-study/

 

[Dx Revision Watch]

The Countess of Mar, Earl Freddie Howe and Lord Tim Clement-Jones are all Patrons to the Young ME Sufferers Trust.

In July, when I approached all three, the Countess of Mar responded expressing support for the issue but explaining that her health would not permit her to take on this issue and that she hoped that Annette Brooke would.

Earl Howe is currently Parliamentary Under-Secretary of State for Quality and was approached in his capacity as a Patron to a children and young person's ME charity. Earl Howe forwarded my email and attachments to "Matthew Harpur/PR-OFF/DOH", who forwarded my email to Bill Davidson, Research Governance Manager, Department of Health.

On 30 July, I received this response on behalf of Earl Howe:

"Thank you for your e-mail of 16th July to the Parliamentary Under-Secretary of State for Quality regarding a research project involving the "Lightning Process" in 8- to 18-year-olds* with myalgic encephalomyelitis. Earl Howe has asked me to reply.

"You are quite right that new treatments should be compared with current standards to see which is better.** You are also right that this comparison should be made in appropriate participant groups.

*Ed: The age range has since been changed to 12 - 18 years old and is 12 - 18 in the Application for ethics approval document and other published SMILE documents.

**Ed: I had not said that I considered LP should be trialled on any patient group in comparison with any current standard.

"New treatments are not generally tried out first in children before there is evidence of their safety and efficacy in adults, but sometimes it is appropriate to do so. It is a matter for a research ethics committee to be assured that the evidence supports the extension of the new treatment to children.

"We require the decisions of research ethics committees to be independent and free from bias and particular stakeholder interests. It would therefore be inappropriate to have a mechanism through which particular stakeholders might seek to affect a research ethics committee's decision. We require research ethics committees that become aware of a possible breach of good practice in research to inform the relevant authorities so that they can take appropriate action.

"Our National Research Ethics Service publishes lay summaries of the research approved by research ethics committees. It is normal practice for researchers also to put details of interventional studies on an open-access register, before the first participant is recruited, unless there is very good reason for delaying disclosure.

"I note that the outcome of the research ethics committee review of the proposal for this project has not yet been reached. I expect it will, in accordance with Department of Health policy, come to a decision that takes account of all the ethical issues, including the appropriateness of the proposed participant group." Bill Davidson, Research Governance Manager, Department of Health

--------------

I have received no acknowledgement or response from Lord Clement-Jones.

-------------

Annette Brooke, MP, had received this response having forwarded my email and enclosures to Rt Hon Andrew Lansley MP, Secretary of State for Health:

From Paul Burstow MP
Minister of State for Care Services

Department of Health

Richmond House
79 Whitehall
London
SW1A 2NS

Tel: 020 7210 4850

12 August 2010

You Ref: cb.1506

PO00000529030


Annette Brooke MP
14 York Road
Broadstone
Dorset BH18 8ET


Dear Annette,

Thank you for your letter of 29 July to Andrew Lansley enclosing correspondence from one of your constituents about the use of the lightning process in the treatment of chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). I am replying as Minister responsible for long-term conditions.

I understand from departmental officials that a trial has been proposed to assess how effective the lightning process can be for the treatment of CFS/ME.

The Department is not involved in this trial. However, we expect those running the trial to ensure that it meets all the regulations regarding medical trials involving children.

I hope this reply is helpful.


PAUL BURSTOW

Approved by the Minister and signed electronically in his absence to avoid delay

----------------

 

[Dx Revision Watch]

The MEA has confirmed that they had worded the House of Lords Written Question.

 

[Dx Revision Watch]

http://www.lightningprocess.com/campaign/

Campaign to increase awareness of ME/CFS as a physical illness

We are launching a public opinion survey designed to raise awareness about current research into the physical nature of this disease. We feel strongly that more people should be made aware that ME/CFS is a real, physically debilitating illness.

Please fill out our survey and pass it on to others to help us raise awareness.

Click here to take survey

( https://www.surveymonkey.com/s/TZ27QKQ )

Many thanks for your help and support.

* If you would like to know the answers for some of these questions, please click here...

( http://www.lightningprocess.com/campaign-answers/ )

------

Campaign to increase awareness of ME/CFS as a physical illnessExit this survey >>
We have designed a public opinion survey to raise awareness about current research into the physical nature of ME/CFS.

Please take a few moments to fill out our short survey and pass it on to your friends/family/colleagues.

The more we can get the message out there that ME/CFS is a physical neurological disease, the better.

 

[Wildcat]

Phil Parkers Lightning Process - now the Phil Parker 'Campaign to increase awareness of ME/CFS as a physical illness' -

Its An Obscenity!!

So that's what they learn on NLP courses - to be manipulative, deceptive, to take double-speak to the limits and to reverse reality for money.

Parkers Lightning Process Trial with Dr Esther Crawley on children with ME will open the NHS doors to every ruthless greedy life coach out there.


NHS
RIP
No ICD
Just NLP

 

[Wildcat]

So Phil Parker says that ME is a physical disease, aphysical disease that can be 'trained' away by standing on a piece of paper and shouting "Stop" at your symptoms at a cost of 650.


What next!! Are we to expect that Rhonda Byrne's 'The Secret' will be given a trial in the NHS as a cure for Neuro Immune diseases?????


Everyone who makes a valid critique of these NLP Life coaching scam ME 'cures' gets called "closed minded" - even when they have more experience of NLP and hypnosis than the Lightning Trainers or Phil Parker himself.



For anyone thinking of being "open minded" and giving life coaching as a 'cure' for ME the benefit of the doubt -

"By all means lets be open minded. But not so open minded that our brains drop out" !!!!
(Richard Dawkins)

 

[Dx Revision Watch]

http://www.meassociation.org.uk/?p=2720

Lightning Process trial and the National Research Ethics Service

by tonybritton on October 28, 2010

The ME Association has written to the National Research Ethics Service (NRES) to ask them to clarify what action they are taking, or may be taking, in relation to concerns that are being expressed about this trial.

We have today received a reply from Joan Kirkbride, Head of Operations at NRES part of which contains the following generic acknowledgement for correspondence relating to this trial:

NRES has received the submissions from the ME Association and others concerning the SMILE study, a childrens study investigating treatment of ME in this age group.

Following our Standard Operating Procedures, we have collated the information weve received and will work with the REC to consider it.

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. 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.​

Joan Kirkbride
Head of Operations, England
National Research Ethics Service (NRES), National Patient Safety Agency
Darlington Primary Care Trust, Dr Piper House
King Street, DARLINGTON, DL3 6JL

MEA editorial note: REC in paragraphs two and three of Joan Kirkbrides letter stands for Regional Ethics Committee.

 

[Dx Revision Watch]

This response from Joan Kirkbride, Head of Operations, England, National Research Ethics Service (NRES), suggests that more than one patient organisations might have been involved in the development of the study. It is known that AYME were involved and that an AYME rep has a seat on the study Advisory Group.

Action for M.E. had denied knowledge of the study design in one of their statements.


According to the MEA's Twitter feeds:

National Ethics Research Service email worth closely considering. Nuggets of hope in it.

Some promising news from National Research Ethics Service about Bath study on LP effects on children.

 

[Dx Revision Watch]

In her response to the MEA, Joan Kirkbride, Head of Operations, NRES, has said:

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. 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.

On 24 August, I wrote to Sir Peter Spencer (CEO) with a query in relation to Action for M.E.'s two published position statements on the proposed Lightning Process pilot study for children:

I asked:


[...]

To date, there is virtually no information in the public domain about the proposed study design and methods and the research protocol is not expected to be published until the end of this month.

a) What is Action for M.E.'s understanding of what will be applied to the children during the life of the pilot study and by whom?

Where has it obtained the information on which it has based its decision to support this pilot study and to support any decision by the ethics committee(s) to grant a "favourable opinion", ie, to approve the application?

b) Would Action for M.E. please set out what information it has relied upon in order to inform its position on this pilot and whether the organisation has made any approaches to the researchers or to any other body to obtain information about the proposed study over and above the press release, and what was the outcome of any approaches made?

Sir Peter Spencer, via email, 24 August, in response to the above:

Our position derives from our detailed reading of the MRC Ethics Guide for medical research involving children and from our understanding of the role of any ethics committee in satisfying itself that appropriate independent arrangements are in place to ensure patient safety."

"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.

"We do, 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, we can see a case for investigating if it is feasible within the Ethics Guide to set up a controlled trial.

I submitted the following request for Information, yesterday (28 October) to University of Bristol Information Rights Officer:

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.

--------------------

(It is already known from the SMILE Protocol document that AYME has a seat on the External Advisory Group.)


Key SMILE documents

3] SMILE Research Protocol

http://www.bristol.ac.uk/ccah/resea...fatigue/smilestudydocuments/smprotv6final.pdf

29] Research Ethics Application Form

http://www.bristol.ac.uk/ccah/resea...atigue/correspondencewithethics/recfrmrfs.pdf

All SMILE documents: http://wp.me/p5foE-37x

 

[LaurieM]

It has occurred to me that if all this LP psycho-babble is meant to be a 'cure' for ME, then why are the UK government placing a lifelong ban on blood donations for those that have or have had ME.

The government say it is for patient protection - but if you are 'cured' then why do you need protecting?

This so called study set up for a single private individuals pseudo-science which would be financed by the the MRC is not just unethical, but a waste of taxpayers money - as well as showing the UK government to be lying as to why the blood ban is about to come into force.

 

[Dolphin]

This so called study set up for a single private individuals pseudo-science which would be financed by the the MRC is not just unethical, but a waste of taxpayers money - as well as showing the UK government to be lying as to why the blood ban is about to come into force.

I don't think the MRC are giving any money to it - one of the Sainsbury Family Trust's are the big funders. However, Esther Crawley has an NIHR research fellowship. I'm not exactly sure how that works but I think it may be that she is paid for 1/2/3 (?) days a week (or equivalent) to do work relating to research and so might use some of that time for this project?