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
RE: SMILE Study

Dear Ms Kirkbride,

Thank you for your letter dated 21st October. I am most grateful for your review of the SMILE study as it is a serious matter of public interest. In this respect a number of developments have occurred that would be valuable to this review.

A letter written by Professor Robin Gill, appearing in Church Times,[1] has been attached. Professor Gill serves on the medical ethics committee of the BMA and has commented strongly with respect to the proposed SMILE Lightning Process trial, stating:

‘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 whenever possible. These adults should be fully informed, and must give their explicit and uncoerced consent….. The coercion of children is not an ethically acceptable option.’

In this regard I have been in contact with the Department of Health for advice on the ethics guidelines for children. Both the MRC ethics guide for research involving children and the GMC guidelines require that research must only be carried out on children if it cannot be feasibly done with adults. And even then, it must only be done if the risk/benefit ratio is favourable after very careful consideration - and as stated above – there must be full uncoerced consent with respect to all the considerations.

Under the MRC guidelines[2] (mirrored by the GMC and Department of Health) assessment of the risk/benefit ration is broken down as follows;

magnitude of harms/benefit, probability of harms/benefit, type of intervention, timing and equity.[3]

Independent surveys show that patients have suffered severe relapses, lasting months to years following the Lightning Process, and that the probability of such harm is 20%.[4]

Whereas Dr Crawley has claimed in her speech to the MRC that the majority of her patients recover within 6 months ‘given a bit of advice on sleep.’ Therefore if the majority of her patients recover so simply why are they being subjected to an untested mentally invasive hypnotherapy programme that carries such a risk of harm due to guilt and blame, when independent surveys show only 25% chance of significant gains from this product?[5]

Furthermore the Lightning Process is very expensive, at £650-£2000 for each patient. Therefore the benefits are limited to a small population of people that can afford it. And as Dr Crawley further stated to the MRC in her presentation – the majority of her patients are from lower socio-economic groups. They are unlikely to ever be able to afford this product. Additionally the type of intervention is similar to Cognitive Behavioural Therapy – a therapy already freely provided by the NHS, indeed it is rather like CBT but with bullying and risks of harm, but no more benefits. Therefore on balance, it seems children are being included only because Dr Crawley has access to them, not because of any logical or clinical need. A DVD presentation of Dr Crawely’s data is included as supporting evidence.[6]

A more serious problem exists with consent – and on this consideration alone I fail to see how the trial can proceed.

The advertising of the Lightning Process literally swamps the internet.

For example a local seller of this product has stated that the Lightning Process will make you ‘completely recover permanently from Myalgic Encephalomyelitis (M.E.)’ further stating ‘there is no possibility of relapse.’[7]

Such adverts would be illegal but for a loophole in ASA rules, and will be illegal from May next year when the ASA covers digital media. It therefore seems perverse that such statements are not allowed for the very reason that they are not supported and therefore dispossess patients of true consent, but are plain for all to see to those entering the study, thus voiding their unfettered consent.

It would be illogical to believe that children will not look on the internet for the Lightning Process if involved in the study. Indeed most of the sellers of this product, including Philip Parker and Alastair Gibson are using the study as a selling point on their websites[8], seemingly legitimising the product before the results are even known, surely unethical in itself.

Therefore how can there ever be fair consent, when all a child has to do is perform an internet search for “Lightning Process”?

It is a strict requirement under the GMC rules regarding research on children under section 39, that there must never be any ‘expectation of therapeutic, financial or any other benefit’[9] yet such expectations are the very way in which this process is sold.

Regarding the related point that trials must not be conducted on children unless they cannot be feasibly done on adults. I have been in contact with a number of Lightning Process practitioners with regard to their expected outcomes for both adults and children, email attached.

As is clear from the original source, the declared results in children are the same as for adults. Since the claim is for an 85% success in adults and 89.7% in children[10], it is hard to see how Dr Crawley supports her statement in this specific instance:-

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

Given that these emails came from the very Lightning Process sellers involved in the study, Mr Alastair Gibson and Mr Philip Parker, and that they are in contact with Dr Crawley, it would appear that the regional ethics committee has been seriously misled.

And if one chooses to ignore the information given by these sellers due to bias, and instead go by independent surveys showing 25% benefit and 20% harm, there is no basis for the study whatsoever - as much harm as benefit would be the expected outcome.

Therefore whatever evidence is used as the basis for the study, it has no ethical foundation to be done on children. It seems that it is not for the benefit of the study participants, but that this study can only benefit the commercial sales giving pseudo-legitimacy to a product currently on the outside of legality.

Finally, whilst Dr Crawley has stated that the charity AYME would act as outside observers to oversee the study, Dr Crawley is also the AYME’s medical advisor and therefore is in a position of authority regarding medical matters, not to mention on close amicable terms one would presume.

Had for example Professor Robin Gill been the outside observer I am sure he would have already halted the study for ethical reasons. Given previous concerns already stated with regards to the relationships between the principals involved in the study there must be serious doubt over the impartial function of oversight.

Therefore I would be glad to give you permission to forward all the information provided, including previous correspondence, to Dr Crawley such that a thorough review of the ethics approval can be made, and assess whether it is appropriate to halt the study. I have also forwarded your details to medical advisors and charities representing ME patients for additional comment and submissions.

Thank you for taking this matter seriously.

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

[2] MRC Ethics Guide : Medical research involving children

[3] ibid., page 16,17

[4] The Young ME Sufferers Trust Joint statement

[5] ibid.

[6] Dr Esther Crawley - DMESG Annual Medical Lecture 2010. Copyright – included for public interest.

[7] Donna Paris - Advanced LP practitioner for Hampshire/Dorset - http://www.donnaparis.co.uk/

[8] ibid., see also http://www.withinspiration.co.uk/ , http://www.lightningprocess.com/ME-CFS-Home/

[9] From GMC website

[10]Phil Parker – Snapshot survey for children with CFS/ME – follow up survey of 1297 selected people attending LP courses in the UK and Norway 107 (8.25%) of whom were children.