If you wish to raise further concerns directly with the team investigating the issue, please email info@nspcc.org.uk and put 'Medical trial on children with ME' ...in the subject line. You can use the following template letter or use part of it to build your own
For the NSPCC team investigating the 'SMILE'/Lightning Process medical research on children with ME.
The protocol for this medical research states that is has been granted ethics approval (despite the treatment in question not having been researched on adults first) 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.”
This contention appears to be based on three UK psychiatric research papers (see 1,2,3 below) and ignores any and all UK and international biomedical research which indicates that ME is the same in children as in adults.
To withhold such contradictory research from the ethics committee is either ignorant, disingenuous or just plain manipulative.
In particular, the work of Professor Belch at Dundee University and Professor Newton at Newcastle University has identified similar biomedical issues in both adults and children with ME.
In the US, as far back as the1990s, Dr Rowe at John Hopkins University introduced the connection between orthostatic intolerance (OI) and ME with subsequent work showing up to 97% of patients affected and it being a particular problem in young people with ME.
In the US, Ryan Baldwin, ME sufferer, was taken away from his parents after false accusations of medical neglect. Ryan was forced to climb stairs (by his court appointed guardian) whilst highly orthostatically intolerant and suffered permanent cardiac damage as a result.
The 'SMILE'/Lightning Process trial protocol appears to ignore such research and public domain evidence and states that it will expect children to set themselves goals "such as standing for longer". This is not just medical negligence. This is cruelty.
In addition, there is growing evidence that the newly discovered human retrovirus, xenotropic murine leukaemia virus-related virus (XMRV), is playing a role in both adults and children with ME. US and UK research puts prevalence of this retrovirus at >85% of ME patients, including children. Note that Ryan Baldwin is XMRV positive. In Norway, two teenagers and an 11 year old have tested positive. Results of a US study which included UK teenagers are awaited.
Given this newly emerging evidence, surely it would be common sense to research the (retro)viral causation of ME and its effects on cardiomyopathy before testing a ‘training therapy’ which requires patients to stand on circles marked ‘choice’ and ‘life you love’ whilst shouting “Stop!” at their symptoms. Would this kind of ‘training therapy’ be tested on children with HIV or cancer, particularly if it had not been researched in adults first ?
Children with ME and their parents suffer enough as a result of ineffective (and often damaging) medical attention and a lack of understanding and support by social services and the educational system. The 'SMILE'/Lightning Process trial is yet another example of how badly the UK ‘system’ is letting these people down.
Please note that this medical research is not sponsored by the NHS but is funded privately by two Sainsbury family trusts (the Linbury and the Ashden). This causes additional difficulties for members of the public who wish to challenge the trial.
1 Hempel S, Chambers D, Bagnall AM, Forbes C. Risk factors for chronic fatigue syndrome/myalgic encephalomyelitis: a systematic scoping review of multiple predictor studies. Psychological Medicine. 2008; 38(7):915-926. SMILE Protocol v6 July 2010 11
2 Viner R, Hotopf M. Childhood predictors of self reported chronic fatigue syndrome/myalgic encephalomyelitis in adults: national birth cohort study. BMJ. 2004; 329(7472):941.
3 Joyce J, Hotopf M, Wessely S. The prognosis of chronic fatigue and chronic fatigue syndrome: a systematic review. QJM. 1997; 90(3):223-233.
Further information
Trial protocol.
http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smile.html
Statements of objection to the trial by the ME Association and the Young ME Sufferers' Trust (4 Aug and 1 Sept).
http://www.meassociation.org.uk/index.php?option=com_content&view=article&id=1363%3Ascientific-trial-involving-children-and-the-lightning-process-is-unethical-says-joint-charities-statement&Itemid=229
http://wp.me/p5foE-35q
Statement of objection to the trial by the 25% ME Group.
http://www.25megroup.org/Campaigning/Awareness%202010/MEGrpLPResearch_Statement.doc
Freedom of Information request ref the trial and responses to this request from Bristol Uni. Note that the Uni declined to answer most of the questions.
http://meagenda.files.wordpress.com/2010/07/foi-lightning-study-chapman-17-06-10.pdf
Request to Bristol Uni for an internal review of the above Freedom of Information responses.
http://wp.me/p5foE-2Yy
Response from Bristol Uni to the request for an internal review of the above Freedom of Information responses.
http://wp.me/p5foE-30R
Advertising Standards Association decision against claims that the Lightning Process can cure ME.
“The ad breached CAP Code clauses 3.1 (Substantiation), and 50.1 (Health and beauty products and therapies).”
http://www.asa.org.uk/Complaints-and-ASA-action/Adjudications/2010/6/Withinspiration/TF_ADJ_48612.aspx
Opinion of the trial by Karl Krysko on Co-Cure.
http://listserv.nodak.edu/cgi-bin/wa.exe?A2=ind1007c&L=co-cure&T=0&F&S&P=3237
Opinion of the trial by Peter Kemp on MEshare.
http://groups.google.co.uk/group/meshare/web/child-experimentation-on-the-nhs
Article about Ryan Baldwin.
Ryan says: "The entire 10 months that I was in the department’s custody, I felt that the treatment I was given was neither appropriate for someone with chronic fatigue syndrome nor for someone who is considered medically disabled. I was placed in the care of foster parents who were told that nothing was medically wrong with me. I was put in homes that were not wheelchair-accessible, [where] I would be forced to climb steps. In addition, I was given physical and psychological treatments designed to either exercise my disabilities away or to convince me that they didn’t exist in the first place."
http://www.mountainx.com/news/2010/091510local-family-feels-vindicated-by-breakthrough-research
For the NSPCC team investigating the 'SMILE'/Lightning Process medical research on children with ME.
The protocol for this medical research states that is has been granted ethics approval (despite the treatment in question not having been researched on adults first) 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.”
This contention appears to be based on three UK psychiatric research papers (see 1,2,3 below) and ignores any and all UK and international biomedical research which indicates that ME is the same in children as in adults.
To withhold such contradictory research from the ethics committee is either ignorant, disingenuous or just plain manipulative.
In particular, the work of Professor Belch at Dundee University and Professor Newton at Newcastle University has identified similar biomedical issues in both adults and children with ME.
In the US, as far back as the1990s, Dr Rowe at John Hopkins University introduced the connection between orthostatic intolerance (OI) and ME with subsequent work showing up to 97% of patients affected and it being a particular problem in young people with ME.
In the US, Ryan Baldwin, ME sufferer, was taken away from his parents after false accusations of medical neglect. Ryan was forced to climb stairs (by his court appointed guardian) whilst highly orthostatically intolerant and suffered permanent cardiac damage as a result.
The 'SMILE'/Lightning Process trial protocol appears to ignore such research and public domain evidence and states that it will expect children to set themselves goals "such as standing for longer". This is not just medical negligence. This is cruelty.
In addition, there is growing evidence that the newly discovered human retrovirus, xenotropic murine leukaemia virus-related virus (XMRV), is playing a role in both adults and children with ME. US and UK research puts prevalence of this retrovirus at >85% of ME patients, including children. Note that Ryan Baldwin is XMRV positive. In Norway, two teenagers and an 11 year old have tested positive. Results of a US study which included UK teenagers are awaited.
Given this newly emerging evidence, surely it would be common sense to research the (retro)viral causation of ME and its effects on cardiomyopathy before testing a ‘training therapy’ which requires patients to stand on circles marked ‘choice’ and ‘life you love’ whilst shouting “Stop!” at their symptoms. Would this kind of ‘training therapy’ be tested on children with HIV or cancer, particularly if it had not been researched in adults first ?
Children with ME and their parents suffer enough as a result of ineffective (and often damaging) medical attention and a lack of understanding and support by social services and the educational system. The 'SMILE'/Lightning Process trial is yet another example of how badly the UK ‘system’ is letting these people down.
Please note that this medical research is not sponsored by the NHS but is funded privately by two Sainsbury family trusts (the Linbury and the Ashden). This causes additional difficulties for members of the public who wish to challenge the trial.
1 Hempel S, Chambers D, Bagnall AM, Forbes C. Risk factors for chronic fatigue syndrome/myalgic encephalomyelitis: a systematic scoping review of multiple predictor studies. Psychological Medicine. 2008; 38(7):915-926. SMILE Protocol v6 July 2010 11
2 Viner R, Hotopf M. Childhood predictors of self reported chronic fatigue syndrome/myalgic encephalomyelitis in adults: national birth cohort study. BMJ. 2004; 329(7472):941.
3 Joyce J, Hotopf M, Wessely S. The prognosis of chronic fatigue and chronic fatigue syndrome: a systematic review. QJM. 1997; 90(3):223-233.
Further information
Trial protocol.
http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smile.html
Statements of objection to the trial by the ME Association and the Young ME Sufferers' Trust (4 Aug and 1 Sept).
http://www.meassociation.org.uk/index.php?option=com_content&view=article&id=1363%3Ascientific-trial-involving-children-and-the-lightning-process-is-unethical-says-joint-charities-statement&Itemid=229
http://wp.me/p5foE-35q
Statement of objection to the trial by the 25% ME Group.
http://www.25megroup.org/Campaigning/Awareness%202010/MEGrpLPResearch_Statement.doc
Freedom of Information request ref the trial and responses to this request from Bristol Uni. Note that the Uni declined to answer most of the questions.
http://meagenda.files.wordpress.com/2010/07/foi-lightning-study-chapman-17-06-10.pdf
Request to Bristol Uni for an internal review of the above Freedom of Information responses.
http://wp.me/p5foE-2Yy
Response from Bristol Uni to the request for an internal review of the above Freedom of Information responses.
http://wp.me/p5foE-30R
Advertising Standards Association decision against claims that the Lightning Process can cure ME.
“The ad breached CAP Code clauses 3.1 (Substantiation), and 50.1 (Health and beauty products and therapies).”
http://www.asa.org.uk/Complaints-and-ASA-action/Adjudications/2010/6/Withinspiration/TF_ADJ_48612.aspx
Opinion of the trial by Karl Krysko on Co-Cure.
http://listserv.nodak.edu/cgi-bin/wa.exe?A2=ind1007c&L=co-cure&T=0&F&S&P=3237
Opinion of the trial by Peter Kemp on MEshare.
http://groups.google.co.uk/group/meshare/web/child-experimentation-on-the-nhs
Article about Ryan Baldwin.
Ryan says: "The entire 10 months that I was in the department’s custody, I felt that the treatment I was given was neither appropriate for someone with chronic fatigue syndrome nor for someone who is considered medically disabled. I was placed in the care of foster parents who were told that nothing was medically wrong with me. I was put in homes that were not wheelchair-accessible, [where] I would be forced to climb steps. In addition, I was given physical and psychological treatments designed to either exercise my disabilities away or to convince me that they didn’t exist in the first place."
http://www.mountainx.com/news/2010/091510local-family-feels-vindicated-by-breakthrough-research