SMILE trial: Summary of Concerns

A trial of The Phil Parker Lightning Process on children newly diagnosed with ‘CFS/ME’ (Chronic Fatigue Syndrome/Myalgic Encephalopathy or Myalgic Encephalomyelitis) 

A small online focus group formed in October 2010 to share various concerns after the SMILE trial passed approval by the South-West 2 Research Ethics Committee in September 2010.  The group included psychologists, educators, former clients of the Lightning Process, patients and parents of children with ME/CFS.  Correspondence with the South-West 2 Research Ethics Committee, National Research Ethics Service, General Medical Council, and Clinical Medical Officer was posted here for reference, and the site is now in the process of being updated (February 2016).

One of the main concerns was that SMILE was processed as a feasibility study, rather than as a clinical trial of a previously untested intervention, when in fact, the trial participants were required to undergo the intervention as an integral part of the feasibility study. The feasibility study went ahead, and results were published on 5th December 2013. Meanwhile, two further favourable opinions were provided by the South West 2 Local Research Ethics Committee on on 31 May 2011 and 6 September 2012 for amendments to study documents and protocol, seemingly to convert the study to a full clinical trial. This trial was completed and publication of the paper was expected by the end of 2015.

Comparing specialist medical care with specialist medical care plus the Lightning Process® for chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME): study protocol for a randomised controlled trial (SMILE Trial). Study Protocol – http://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-14-444

The following summary relates to the July 2010 trial protocol and process of ethics
approval for the SMILE trial as a feasibility study in 2010.

SMILE (Specialist Medical Intervention and Lightning Evaluation)
Assessing the feasibility and acceptability of comparing the Lightning Process with  specialist medical care for Chronic Fatigue Syndrome or Myalgic Encephalopathy (CFS/ME) – pilot Randomised Controlled Trial.

“The protocol for this experiment using a novel and unpredictable psychotropic process on vulnerable children should leave nothing to the imagination.” ‘frown at SMILE’, 2010.

Main Issues of Concern

1.  There was no sound justification for conducting this research on
children before its safety and effectiveness had been assessed in adults.

2.  The Lightning Process is advertised as a non-medical tool and the
LP practitioners are not medically qualified, yet the PI claimed that
this was a study of treatment for ME/CFS.

3.  In Q2 of the study application form, the lead researcher (Dr. Esther Crawley)
did not declare this to be a clinical trial, yet the children were to undergo the
Lightning Process as part of the feasibility study.

4.  Dr. Esther Crawley claimed that it was necessary to assess
the safety and effectiveness of the Lightning Process, yet in QA22, she replied,
“We do not believe there are any risks of being part of this study.”
Minutes of the SW ethics committee meeting (10) show that Dr. Esther Crawley was
aware there are risks to patients from doing the Lightning Process.

5. The trial participants were denied their right to give informed consent
to take part in the research, in breach of the Declaration of Helsinki.

6. Child Protection concerns regarding risk to the trial participants mental and physical health; and the Lightning Process research collaborators were trading in breach of Advertising & Trading regulations.

SUMMARY OF CONCERNS RAISED BY ‘frown at SMILE’ in 2010

Failure to –
• process SMILE as a clinical trial
• meet official guidelines for research in children
• take account of existing (and new) research on children with ME/CFS
• justify why the research should be done
• disclose risks (psychological and physical) of the LP intervention
• protect the safety of trial participants
• informed consent in breach of the Declaration of Helsinki
• declare financial incentive for trial participants
• declare conflicts of interest of key investigators/collaborators in the study
• ensure impartiality of ‘Independent Advisory Group’

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