Reply from NRES – no further action – 14th April 2011

Our Correspondence with Director of National Research Ethics Service

From NRES Director –

Further to your email of 8th April, complaints must be managed within the policy timelines. I appreciate that this, as an ongoing study, may generate new issues outside what has currently been investigated but at this stage I consider all matters raised have been fully investigated.

Specifically, I was aware of the outstanding response, I reviewed the draft response and have given my approval for the reply to be sent. I do not believe NRES needs to take further action at this time.

Yours sincerely
Dr Janet Wisely
Director National Research Ethics Service
National Patient Safety Agency
4-8 Maple StreetLondon W1T 5HD
Tel: 020 7927 9898Fax: 020 7927 9899
queries@nres.npsa.nhs.uk
http://www.nres.npsa.nhs.uk
April 2011

From Patient Advocate 8th April 2011

Dear Dr. Wisely,

I refer to your response to my complaint of 7th April.

I accept that you may have dealt with some aspects of this particular issue internally during the course of your investigation, but I do not feel that it has been addressed satisfactorily as far as the public is concerned. It also seems that your investigation may have concluded prematurely – before Mrs. Kirkbride and Dr. Davies had completed their replies to responses to the REC review of their decision.

As you know, members of the public were given false information in the apology to Phil Parker and were asked to publicise it, as described in my letter to Mrs. Kirbride of 1st April, which I copied to you for your information. I was also given false information in Mrs. Kirkbride’s letter to me of 16th March, which you can also see from my letter of 1st April. No attempt has been made to correct this information or further apology made public. I realise you may have concluded, during the course of your investigation, that it had not been appropriate to issue a public apology to Phil Parker, but having made that mistake, it should be rectified.

I expect you will have noted from your investigation that the major objections to this study from the outset derive from this very problem of false, incomplete, misleading information, and unsubstantiated claims made publicly by members of the research team involved with the intervention arm of the study – which potential recruits were advised to read for themselves to help them decide whether to take part – and also made by the lead researcher, for example by stating she did not believe there to be risks to the participants, and by not declaring this to be a clinical trial, even though one of her stated aims was to assess the safety of this product, allegedly because around 250 children per year were already using it. No evidence was provided that this number of children are doing the LP and there cannot possibly be no risks declared to patients taking part in a study of a product that is being tested for its safety. A further misleading element of the study is that the LP is described by Phil Parker as a “non-medical tool”, yet claims have been made throughout that the research aims to evaluate treatments that may come into mainstream use in the NHS as a result of the full RCT that may follow from this pilot study.

It seems clear that this study was fraught with flaws from the outset. It can be seen from the documentation posted on the Bristol University website that the SW2REC had to make several suggestions for improvements prior to its original decision to grant approval. The study proposal was of poor quality and I believe that the REC did its best, with the information and assurances it was given by the lead researcher, to assist her in meeting the standard required for approval.

The difficulty, as I see it, has arisen by the REC subsequently failing to give sufficient weight to the new and very relevant information that was presented to them prior to and since their review. It is repeatedly stated throughout the notes on your investigation, that the REC may take new information into account in order to review a decision. I realise you may conclude that this was the case, and that the REC found in favour of the research team. In which case, it seems that the ethics service gives more weight to “thoughts, feelings, beliefs, opinions and views” of researchers than to facts, existing evidence that should inform the research proposal, and scientific quality.

This is not a full complaint. I will be writing to the Chief Executive as you advised and to the Ombudsman, but have not yet had time to fully digest the documents you kindly sent summarising your investigation, or the letter sent by Mrs Kirkbride in reply to our response to the minutes of the ethics committee review meeting.

In the meantime, I wanted to give you the opportunity to consider whether the NRES should take steps to rectify the false information given to the public and to consider whether you agree with Mrs.Kirkbride’s view that the information provided in a recent letter from Trading Standards that was forwarded to her, is not relevant to the ethical considerations of this study – i.e. that Phil Parker, member of the research team and designer of the Lightning Process, is currently the subject of Trading Standards and Advertising Standards Authority investigation for misleading and aggressive selling practices – as he is likely to comply with the law when advised by them to do so – otherwise of course, he risks prosecution, as stated in the letter by the TS investigating officer.

I am sure you will appreciate that it is our concern for the dignity, safety and well-being of the paediatric patients involved in this study that drives these requests to take such information into account. The letter from the Trading Standards Officer post-dates your investigation. I repeat that my concerns and complaints are in no way vexatious in intention and I have no vested interest in whether or not this study is completed.

Yours sincerely,

From NRES Director 7th April 2011 – 

Thank you for your email of 6th April. I can confirm that the matter of the error in the REC minutes, subsequent correction and apology were part of my original investigation as I considered in this investigation the complete set of correspondence and events with the study and management by NRES staff. It is therefore a matter that has been thoroughly and fully investigated by NRES through the NPSA Complaints Policy.

Yours sincerely

Dr Janet Wisely

Director National Research Ethics Service

National Patient Safety Agency

4-8 Maple Street London

W1T 5HD

From Patient Advocate 6th April 2011 – 

Dear Dr. Wisely,

Thank you for your letter of 5th April and the helpful attachments.

I believe that the REC concerned did not take the relevant new
information received regarding this piece of research into account for
its review and so I will be taking that matter further with the
relevant bodies, as you have advised.

In the meantime, you have not addressed my complaint against Mrs.
Kirkbride regarding the untruthful information she provided in her
public apology to Phil Parker, and which she requested the recipients
to publicise.

I would like you to note that I do appreciate the complexity and
volume of work that this matter has generated for Mrs. Kirkbride, and
that I note from the attachment that this was unprecedented in her
experience.  My complaint is in no way vexatious.

I am sure you will appreciate the seriousness of this complaint, which
I presume was not among the ‘matters that have already been thoroughly
and fully investigated under this complaints procedure’.

Your sincerely,

 

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NRES reply to our response to December 2010 ethics review of SMILE – 6th April 2011

Letter from National Research Ethics Service 6th April 2011 – 

Re: Pilot Study of Lightning Process in Children with ME/CFS (SMILE)

Thank you for your letter of 16 January 2011 about this study. NRES is aware that a number of people remain concerned about the decision of the South West 2 REC to uphold their favourable opinion of the above study.  In view of the further concerns expressed, as you have been advised, Dr Janet Wisely has asked the National Research Ethics Advisory Panel to consider the actions to date carried out by NRES and we are writing to address your concerns. Given the length of your letter we have taken time to consider your comments.

We have grouped your comments and reply as below

I Research involving children: is this study acceptable?

This was considered in our preparatory paperwork and discussed in committee.  It was felt that this research met the RCPCH criteria for research involving young people and children.  As you are aware NRES provided support to the South West 2 REC during the second review of the application with ethical advice provided by  Dr. Hugh Davies, NRES Ethics Advisor.  Dr Davies also holds the post of Consultant Paediatrician within the NHS and provides training courses on ethical issues involving children.   We would wish to assure you that research on vulnerable groups is an area which is given additional consideration by RECs and the SW2 REC has expertise to review paediatric research.

II Research into ME

You wrote-

 “You describe this study as, “exploring how best we might treat children with Myalgic Enchephalitis (Encephalomyelitis) or Chronic Fatigue Syndrome”. This study does nothing of the sort. The Lightning Process cannot “treat” children with ME or CFS, partly as it is not a treatment at all, but also because it cannot be considered as a “treatment” for neuro-immune disease. You are aware that Myalgic Encephalomyelitis is a neurological disease at WHO ICD-10 G.93.3. Chronic Fatigue Syndrome, an invented term that is now, regrettably, used interchangeably in UK with ME, was annexed to ME by WHO in 2004 to avoid the confusion this unnecessary and unhelpful new term caused. The APPG Inquiry into NHS service provision that Esther Crawley referred to at her meeting with the committee, confirms acceptance of ME as neurological and this was re-confirmed by the coalition government in parliament last year. A ban on donation of blood by anyone who has ever had ME/CFS – so this would include anyone who had it as a child – was imposed on 1st November 2010 for donor safety on the basis that it is known to be a relapsing and remitting condition. “

The committee discussed the issue of research on children with ME at their meeting before the researcher attended, during discussions with the research team and afterwards. They understood the contended origins of ME and CFS. The cause remains uncertain but this need not restrain research into potential management and treatment.   There are many instances where therapy has gone ahead of full understanding of a disease. The task of an REC is then, independent of consideration of the underlying cause, to consider the proposed therapy and its attendant risks and benefits.  The REC did this and on balance felt the trial was justified.  They were satisfied that this intervention is a treatment in use and the ethical way forward is to research its true efficacy.  They were also satisfied that children would continue to receive their current “standard of care” treatment.

You referred also to the APPG Inquiry. It was noted that the Inquiry received both written and oral evidence that the Lightening Process can be very effective but did point out that, like many CFS/ ME treatments, it is not suitable or effective for all patients. This Group suggested that further investigation of its efficacy might be undertaken.  This research would seem to fulfill this request.

III The causes of ME

You  wrote

“Given that ME/CFS is a neurological disease, why has the NRES/SW REC consented to research on so-called “treatment” of children that is based on an alternative hypothesis of the condition that has not been scientifically proven? “

In conclusion, it is pointless wasting valuable resources on “treatment”  research before the true aetiology of the disease is established as a valid basis for researching treatments. There can be no excuses here. There is already ample biomedical evidence that can be used as basis for further ME/CFS research; this includes evidence for children with ME/CFS and could be used to find proper treatments. The study co-funded by ME Research UK and TYMES is a prime and recent example of this. It is totally insupportable to proceed with this study in the light of the findings of persistent viral infection in children with ME/CFS – the same as was found in adults with ME/CFS in 2005.

Esther Crawley has espoused the biopsychosocial model of “CFS/ME” on which CBT and GET as “treatments” are based. CBT and GET are proving to be ineffective in RCTs because they are based on an incorrect model of the processes at work in ME/CFS. It looks very like Esther Crawley has now, therefore, turned her attention to the LP, also based on the biopsychosocial illness model, as CBT and GET are falling out of favour. The biopsychosocial illness model for ME/CFS is wrong –  ME/CFS is no more biopsychosocial than any other disease – and is in conflict with World Health Organisation and UK government classification as a neurological disease. This study is simply the latest in a line of poorly designed pseudo-research that will take us no further forward in finding true cause and effective treatment for ME/CFS. Approval of this study merely serves to endorse the disgraceful history of medical abuse and negligence of ME patients – including children – over the past 25 years or more. It should be stopped now.

The REC understood the current debate about the cause(s) of ME and took this uncertainty into account.  They felt the trial was a pragmatic approach, investigating a treatment currently being used, regardless of the underlying cause(s) of the condition (see III). We note your reference to the APPG Inquiry but also note that it states “ME/CFS is an extremely complex disease covering a range of symptoms and clinical presentations. There is currently no scientifically proven cause or cure”. 

IV Biomarkers and ME

You wrote

“There are fewer uncertainties, as you put it, of the treatment of this condition than you may have been led to believe. Firstly, one basic explanation of the differences in outcomes for patients with various therapies is the uncertain diagnosis of the condition. There are biomarkers that could be used for diagnostic purposes but are not used in UK. “

This was discussed with the researchers, and the view was accepted that as these biomarkers are not used in the UK, where the research is to be conducted, it would not be feasible to use them.

V Is Myalgic Encephalomyelitis a distinct condition?

  You wrote

“ ..disease entity (ME) and its effects on the body can be found and measured with the correct assessments, which are not routinely carried out in the NHS. Chronic Fatigue Syndrome is a term that was invented in the 1980s, with the upshot that patients with M.E were re-labelled as having CFS, to the extent that some doctors in UK even refuse to recognise or use the term M.E; and many patients suffering the symptom of chronic fatigue due to other causes, some of which may be mental health problems such as anxiety or depressive disorders, are given the label CFS. This means that probably all patients with M.E are diagnosed by NHS doctors as having CFS/ME, but not all patients given a CFS/ME diagnosis have M.E, and this applies to children too. Then take into account the added complexities of adolescents – the target group of this study – how easy it is to label them with CFS/ME as a reason for their difficulties, without the use of disease biomarkers.

I hope you can see the inherent difficulties this poses for any research on the condition, and how it is in fact an obstacle to any hope of achieving reliable results that could be extrapolated to the broader ME/CFS patient population. Basically, every diagnosis of CFS is a misdiagnosis. Patients either have M.E or some other condition that the diagnosing doctor has not found on routine testing.

This means that the best conclusion that can be hoped for from the full RCT that could follow on from this feasibility study is that x number of the study participants improved, worsened or experienced no change, which adds no more value to the existing survey data. This is simply history repeating itself from the CBT and GET RCTs. “

“Results of the FINE trial were published last year; publication of the PACE trial results are way overdue but will provide useless data in any case as criteria for patient participation included the absence of neurological signs and symptoms (so it bears no relevance to ME/CFS) in a similar vein to the exclusion in this study of children too unwell with ME to attend clinic. Information from any study of treatment will not be useful for future studies, or a guide for parents and children with M.E, until biomarkers for positive diagnosis of ME/CFS are used for patient selection. This feasibility study is therefore pointless in terms of useful research. “

If Esther Crawley is genuinely concerned about science, then she should know that a study of the efficacy of LP with a specific patient group cannot be deemed to be scientific until the premise on which it is based is scientifically proven. Should not Esther Crawley focus her research efforts on that first, if her studies are to be accepted as “detailed scientific studies”? It is irrelevant that this is “only” a feasibility study, as its purpose is to ascertain the feasibility of a full RCT, and also the participants will be undergoing the LP for the purpose

of this study; hence the secondary outcome of the study – what would be the relevance of whether children return to their former education, if the aim is merely to ascertain feasibility of a full RCT via recruitment and retention figures?

The REC recognised the challenge of diagnosis and classification in this area and the consequent need to consider results carefully. This always applies to all research and it must be for the reader of any report to understand selection criteria and consider if the results can help his or her clinical work. It would be invidious for debate about diagnostic criteria to hinder evaluation of any treatment. As these children presenting with this array of symptoms are a common problem to paediatricians,  any attempt to help them needs to be considered and evaluated.

VI Surveys and RCTs

You wrote

“Patient surveys had already shown what the RCTs eventually showed.”

RCTs  are a more solid grounding for treatment. They may indeed “confirm surveys” but surveys can be flawed and are not generally regarded as the best foundation for planning treatment.

VII ME in children and adults

You wrote

Esther Crawley claims that ME/CFS is different in adults to children and that treatment outcomes are consequently possibly also different, yet she fully endorses the NICE guidelines that currently recommend exactly the same “treatments” for children as adults: Cognitive Behaviour Therapy and Graded Exercise Therapy. It is these two therapies that constitute the “specialist medical care”  that the REC seems to be so reassured the study participants will not miss out on.

 What evidence was provided that treatment (assuming the question was about LP) is “very different” for children and adults? Given that a high degree of secrecy is demanded of participants in the standard LP that is on sale, this will not be public knowledge, and the committee has already dismissed accounts of LP by people who have done it as “anecdotal”.

Current standard “treatments” for ME/CFS and LP are two separate issues. Dr. Crawley has failed to provide evidence that standard treatment for children and adults is different. CBT and GET are currently offered to both groups of patients and, as stated, there is no data for effectiveness of treatment in children. Why not? Why has Esther Crawley not seen fit to engage in research to provide this data? Esther Crawley has endorsed, and indeed advised on, NICE guidelines for “treatment” of CFS/ME. For symptom management, there may be differences in medications prescribed for adults and children, but medication is not the subject under question with regard to this study. The committee has failed to acknowledge that LP is NOT a therapy. It is offered as a training programme. Any “uncertainty” over treatment has nothing whatever to do with LP because LP is NOT a treatment.

The REC felt there was adequate information in the application, protocol and in discussion with the researcher. The committee accepted the researcher’s claim that ME/CFS is different in adults to children and that these differences in childhood and adult ME that might have consequences for treatment and hence  the need to conduct this study in children. This, again, was felt to be in line with guidance from the RCPCH.

VIII Risk

You wrote

On the other hand, it uses survey data from adults to support the risk assessment for this study in children. It cannot go both ways. If the study should go ahead on the basis that results in adults cannot be extrapolated to children, then the risk cannot be assessed using survey data provided by adults. If evidence of risk is anecdotal, then how has the evidence for no risk or low risk been obtained? If this anecdotal evidence reinforces the need for research, why does it specifically reinforce the need for this research in children?

Given the paucity of paediatric research in this area, it’s difficult to find data. In such cases, data from adult studies can be taken into consideration but we would agree that this needs caution. The REC considered safety very carefully and on balance felt it had a favourable risk/benefit profile.

IX Research in  children

You wrote

“Let that scientific hypothesis be proven before testing the product on children, and considering Esther Crawley’s claims of the difference between adults and children, let that hypothesis be proven to be true for children before testing the Lightning Process on them. To allow testing of this product before the hypothesis on which it is based is “

“I do not doubt the good intentions of the SW REC or the NRES. It is very clear, however, that even the most basic issue regarding the ethics of research on children was overlooked, by taking Esther Crawley’s claim that there are no risks in this research purely on trust and without question or investigation of the truth of that claim.”

“Why is it phrased that, “The complainants claim that it is not appropriate to research children before work has been conducted in an adult population that can give consent”? This is the official guidance for research. It seems that the committee felt that respondents had quoted selectively from guidance. Did the committee not feel that Esther Crawley had been selective in the information she had presented in her study proposal? This statement

gives the strong impression that the committee does not take research on children with ME/CFS at all seriously, nor does it seem concerned that a researcher has been selective in the information provided to gain ethics approval. These children are not dolls and this is not a point-scoring game. “

This was discussed at the REC and taking into consideration the RCPCH guidance on research involving children, it was felt reasonable to proceed with this study (see also above)

X Patient information

You wrote

“Is it not a basic right of patients to be told of the potential risks of any treatment? “

The REC was satisfied with the information to be provide to children and families

XI The researcher’s suitability

You expressed concerns about Dr Esther Crawley’s lack of competency with respect to children with M.E/CFS, and her lack of professional judgement with regard to this particular study, were already in the public domain.

  “She stated it was vital that all treatments, including CBT, GET etc., should be offered by specialists who have received specialist training with ME/CFS patients”, yet now she herself is about to do research on children with practitioners who are not even medically or clinically qualified, let alone who have training in the neurological disease ME/CFS. How can Esther Crawley justify the legitimacy of this study, given her own views as on record in the APPG Inquiry?

The REC felt that the research team as a whole had the required expertise. Given her CV, her experience in this field and the discussion at the meeting, the REC were reassured that she and her team had the expertise to conduct this research. It also had a strong letter of endorsement from Mary Jane Willows CEO of AYME.

XII Conflicts of Interest

You asked

“Please specify the conflicts of interest in this study and clarify where these are declared in the study proposal. “

Question 48 of the application form requires the applicant to declare conflicts of interest.  None were declared.  The application form is available on the University of Bristol website. These were discussed according to Royal College of Physicians’ recommendation and were felt to be satisfactorily managed

XIII Patient participation in research design

You refer to the active participation in the study of The AYME.

“ Esther Crawley is Medical Advisor to the AYME. The AYME relies on Esther Crawley for its medical advice. It is hardly surprising,therefore, that the charity supports this study. Esther Rantzen is President of the AYME. She openly endorses The Lightning Process in the media. Action for ME is a sister charity to AYME and both have links with the Bath Hospital at which children for this study will be recruited. The Chief Executive of AfME is non-executive director on the hospital board. Action for ME receives revenue for advertising LP in its charity magazine, Interaction. Discussion of the ethics and potential validity of this study has therefore been totally one-sided. The researchers had ample time to submit and revise their proposal initially, without the involvement of other interested parties, such as The ME Association and The Tymes Trust for ME Sufferers, and now have been given the opportunity to discuss it in person, which those opposing the study have not.

The role of the AYME was considered at the meeting and felt to be appropriate. In line with government and NHS policy, patient participation is encouraged in designing and developing research.

XIV NRES procedure

We highlight that this received full review, and favourable opinion and that when concerns were raised,  NRES  drew up a list of all issues under debate and asked the REC to reconsider the new information at a scheduled meeting in accordance with NRES Standard Operating Procedure 9.86. Again, in accordance with NRES Standard Operating Procedures, the researcher was invited and attended. A representative  of AYME was due to attend but fell ill so submitted  a written report. This clearly follows due process and allowed this new information to be reconsidered.

Your wrote

“The 15 questions put to the researchers do not address some of the most important issues raised in the representations it received and so remain unresolved by this meeting. “


We believe that the paper addressed issues submitted to us and full debate at the meeting followed.

XV Complaint registered with the Advertising Standards Authority

With regard to corrective action taken by Phil Parker following the adjudication of the Advertising Standards Authority, the ASA only has powers to rule against banner ads, and so the corrective action taken was simply to remove the offending advertisement. The false claims made about LP remain throughout the LP website, which study participants are directed to read and which will therefore, undoubtedly affect their agreement to participate in the study. A pdf was attached in a letter to the SW REC following their original decision, highlighting several examples of these unsubstantiated claims and misinformation about ME/CFS on the study practitioner, Alastair Gibson’s website. Perhaps Mr. Parker is unaware that a case for legal action against him is being prepared. Did the NRES request evidence of this from the complainant to check the accuracy of this claim?

The minutes read, “The protocol and application clearly state that practitioners had been informed that they must make NO therapeutic claims on the basis of this study”. This does not adequately address the problem that therapeutic claims are made on the LP website and that the study participants have been specifically asked to read this information. How can participants not be exposed to therapeutic claims about LP when they read about it, as the promise of therapeutic gain is precisely the basis on which the programme is sold. The LP information states that any lack of success on the programme is due to the patient not doing it properly and that the only way to rectify this is to have yet more LP. Will the PIS direct study recruits as to which information provided by the LP sales material to ignore and which to accept as accurate?

NRES and the REC consider the information to be presented to potential participants.  It’s recognised that, as with many other treatments, claims will be made elsewhere. The REC’s duty is to ensure that the potential participants are given information at the time so they understand that they are being invited to join a research project and that the outcome is uncertain (hence the need for the research). Other matters are outside the remit of evaluating the information provided to families and should more appropriately be taken up with other bodies.

XVI  Risk

You  wrote

It is clear that the committee has no idea about Myalgic Encephalomyelitis if it can, “feel there may be a slight risk of a child being worse after therapy”, and that this risk is acceptable on the basis that the child can withdraw. What evidence is there to support this conclusion? Damage done to patients with ME is often irreversible, so it will be too late to withdraw to avoid harm. If there is a risk that even one child could be harmed by LP then this study should not be done.

5. It is also clear from her evidence to the Inquiry that she was aware of the risk of LP to adults at least. Why did she not disclose this risk in her study proposal?

8. On what basis can this risk be described as “slight”? 

6. The APPG also noted that, while it is impossible for all treatments in a disease area to be side-effect free, if CBT and GET were licensed medications, this number of adverse reactions reported by patients would prompt a review by NICE and that these same standards should apply to CBT and GET. With regard to research, does not the number of 20.8% of 101 patients having tried LP and being made worse by it, not prompt the need for extreme caution in researching it on children?

The protocol and the application form along with interview of the researcher incorporated this and the risk benefit profile was felt to be appropriate

It is insupportable to do this research before:

a) the scientific premise on which LP is based has been proved and,

b) the research has been done with adults, unless the scientific research shows that the illness is indeed different in adults and children.

The REC understood  the current debate about the cause(s)  of ME and took this uncertainty into account.  They felt the trial was a pragmatic approach, investigating a treatment currently being used, regardless of the underlying cause(s) of the condition.

The REC felt the projects was within the recommendation and guidance of the RCPCH

You wrote

“The committee was assured that, “Supervision of the process was in place”. By whom? An expert, independent observer? The parents?

10. AYME is an organisation that is independent of neither the LP nor of the lead researcher of this study. How can AYME be deemed a “service user”? Patients are the service users, surely? Study participants are to be recruited at the point if initial diagnosis and so, presumably, will not be members of AYME. Will membership of AYME be a requirement for study recruits? AYME clearly does not represent the views or interests of all children with ME or their families. Does it even represent the views of all its members? Do members of AYME have voting rights or are they merely subscribers, as is the case with AfME? Were all members of AYME invited to endorse this study or does the view of AYME in reality mean the view of its medical adviser, Esther Crawley, its president, Esther Rantzen, and possibly its trustees? Does AYME receive revenue for placing ads for LP in its charity magazine, as does AfME?

11. Surely, the External Advisory Group should be independent of the researchers?

AYME is not an independent organisation with regard to this research. Its President, Esther Rantzen, openly endorses LP in the media and its Medical Advisor is the lead researcher of the study, is Esther Crawley.

The research is being supervised and sponsored by a well established Academic organization, the University of Bristol.

12. Knowledge that LP when sold commercially, is coercive and bullying, exacerbates the risks involved in this research and casts grave doubts over its acceptability as any form of “treatment” for any health condition, especially for children. Please specify the processes and precautions that will be in place that the committee has found so reassuring.

These are in the application, were discussed with the researcher and are in the minutes of the meeting

13. If the LP to be used in this research is not the same as, nor carried out in the same way as the LP currently sold commercially, surely it cannot rightfully or truthfully be called LP. To do so, distorts any conclusions arising about the LP. It is not acceptable to counter that this is merely a feasibility study, as the findings of this study will be used to decide whether or not to go ahead with a full-scale RCT of LP, so researchers, patients and LP consumers alike, need to know exactly what the programme is that is being studied. Unless this is fully explained, the public and patients are being misled, as LP is publicly and commercially available.

The REC understood that the LP would be as is usual practices but with additional observation and supervision to mitigate risk

14. The committee is mistaken to assume that this study will provide any useful data on children with ME, regardless of severity. That they are teenagers makes it even more invalid, given the physical and psychological changes that adolescents experience.

This opinion was not shared by the REC

15. The priorities for research on children with ME should be to establish the true cause of onset of illness and of the ongoing nature and variability of the disease process and to establish reliable biomarkers for the disease. Any other research is a waste of precious time in these children’s already short lives. Without disease biomarkers, who knows what condition the children diagnosed by Esther Crawley as having “CFS/ME”  really suffer from. Some of them will have Myalgic Encephalomyelitis, the organic neurological disease as defined by the WHO at ICD-10 G.93.3. Others will have other health conditions, lumped under the waste-basket diagnosis of Chronic Fatigue Syndrome, which the WHO annexed to ME in 2004 in order to avoid the confusion that the introduction of this ridiculous term caused among medics, researchers and patients. The only way to effectively help any of these children is to firmly establish a true medical evaluation of the cause of their symptoms, as individual patients; whether those be organic in origin, as in ME, or whether they be physical manifestations of psychological processes such as anxiety, phobia and so on, which

It was felt that debate about the true cause of ME, while of vital importance, should not stand in the way of therapeutic trials. All involved, the REC, sponsors  and the researchers, recognised our ignorance but are motivated to help the children with these symptoms.

XVII Child protection

What further Child Protection measures will be taken to ensure the safety of the study participants at all times and at all stages of the study?

These are detailed in the minutes

 With regard to all sessions being recorded, will this be video or just audio recording and will the whole of each session be recorded?

Details are in the minutes

Should not all the sessions be observed by someone trained in child protection and medically qualified, considering the lack of clinical qualification of the practitioner?

That was not deemed necessary

Given the reports you have received of how the LP actually works –  e.g. that patients are persuaded to say they are no longer “doing ME” at the end of the programme and are told to deny their symptoms – and that LP is not a medical form of treatment, does the committee agree that special care is necessary, over and above that which may normally be applied in research?

The risk benefit profile of the research was debated and arrangements felt to be adequate and commensurate

Further questions

1. What evidence did Esther Crawley provide the committee that she had received representation from children and families to conduct this research, or is this evidence merely anecdotal?

The written report of the representative of AYME confirmed that the research was planned with contributions from families

2 How many requests did she receive?

3. Were the requests from children and families having already undergone LP or wanting advice about whether to try it?

Given the information the REC had to hand and the report from AYME, this was not felt to be relevant. If you require this information, Dr Crawley would need to provide it.

4. Is it normal practice for research to be conducted on the basis of such requests from children and families?

The participation of patients in the design of research is encouraged and part of NHS policy

5.Support from the AYME is a given, as Esther Crawley is the charity’s medical adviser and its president, Esther Rantzen, openly endorses LP in the media. Did Esther Crawley seek the views or advice of the other charities experienced in and involved with research such as The ME Association, ME Research UK or Invest in ME or the longest-running charity for children with ME that won the Queen’s award in 2010, The Young ME Sufferers Trust? If not, why not?

Once the protocol was written the study has undergone independent review

Q2 “There has been a high recruitment rate so far.” .

There is no reason why recruitment for the study should not be high, as was pointed out by complainants, and this is why the outcome of this feasibility study is a foregone conclusion and will be used to apply for a full RCT. Consider the following points. Children are recruited at the point of initial diagnosis by a paediatrician (whom patients and their parents will trust) at the specialist “CFS/ME” clinic at an NHS hospital for rheumatic diseases. They are being offered a programme that is in addition to the “treatment” they would normally receive, not as an alternative. The study is reassuringly called SMILE. The programme on offer is usually sold at upwards of £600 per person – a financial inducement to participate.

The REC considered the information for participants and made the judgment that they would not be the subject of undue influence

Were these recruits told of the risks that the committee has now advised should be included in the patient information or not? If not, will they now be told? How will they be informed?

This was not felt to be of sufficient concern to be necessary. Prospectively, they would receive the modified information sheet.

What exactly does the LP in this study consist of and in what way is it different to the programme on sale to adults and children?

It was understood that the LP procedures used would be in the study report. Clinicians and patients would then be able to make their own decisions and draw their own conclusions.

3. If the question was about the standard NHS “treatment”, what evidence did Esther Crawley provide that this is different for adults and children?

She provided information in the application and the protocol.

4. Does this mean that she does not follow current NICE guidelines for “CFS/ME”? 

This needs to be addressed to Dr Crawley

5. Esther Crawley claims that the focus in treatment of children is recovery. What evidence does she have for recovery rates in children and how was this recovery achieved?

The point of this research is to determine if it’s feasible to answer this question

6. Why does she not focus research on looking at those children who have recovered, the history of their illness onset and progression, range and severity of symptoms and what factors may have led to recovery, before launching into a study of an unlicensed product on such children?

This should be addressed to Dr Crawley but in scientific convention such studies would not provide robust evidence

7. What is the relevance of her comment about paediatric services dealing with education rather than work?

8. What difference does this make to treatment approaches and outcomes?

One of the primary aims of any children’s clinic is to enable the child into education rather than work.

9. Why is there a need to evaluate if LP works, simply because children are being exposed to it?

The REC understood and accepted that it is one of many possible treatments being used in these conditions or circumstances

10. Why doesn’t Esther Crawley simply advise AYME, her patients and their parents that the premise on which LP is based is not scientifically proven, and that they should treat LP with the same caution as they would any other complementary or alternative therapy, especially as it is advertised as a training programme and not as a therapy?

The information to families explains the uncertainty about the treatment’s effectiveness and the rationale of the study.

11. What is a specialist NHS doctor doing even being involved with the evaluation of a nonmedical training programme in children, when the premise on which it is based is not scientifically proven?

The rationale for this study is to evaluate this treatment, one in current use, to shape future care.

Q5 It is alarming that the qualifications of the practitioners should have only been considered by the committee after representations from the public were received. It is equally alarming that the committee should simply be satisfied with one doctor’s recommendation that the practitioner, “is good”. The fact that she has worked with him before casts doubt on her claim that she is only carrying out this study at the request of children and families and to assess the safety of LP. If she has worked with him before, and judges him to be good, then she must have an expectation of the positive outcome of the study and this is reflected in her original denial of any risks to the children involved. It seems that the committee’s approval is based largely on Esther Crawley’s views and assurances, given the lack of independence in this matter of AYME.

There seems to be more than one doctor’s recommendation for this process. It has the support of some members of the “ME community”, as judged by the CEO of AYME.

The underlined section misunderstands the nature of scientific trials. It is the treatment that is being studied to determine whether it is effective, independent of the researcher’s view of the practitioner, and Dr Crawley was clear about this at the committee meeting.

Has the committee been told what the LP actually consists of in practice, how it is supposed to work and what health improvements may be derived from it?

Adequate details were felt to be in the application and the discussion with the researcher.

Q6 1. Esther Crawley has been selective in her citation of survey data published in the APPG Inquiry into Service Provision for ME/CFS, by claiming that LP fared better than CBT and GET. She criticises patient survey data as unreliable and accepts that the data provided to the inquiry was based on adults, not children, so the fact that LP “fared better”  than CBT and GET is irrelevant to her argument for support for this study. She is also quoted as saying in the inquiry report that it is “dangerous” to only accept patient evidence and not detailed scientific studies, so why quote it in support of her study?

Given this uncertainty and valid criticism of survey data, this RCT is needed

Esther Crawley also gave oral evidence to the APPG Inquiry in defence of CBT and GET. She stated that evidence suggests that long term strategies of CBT were successful. This has since been shown in the FINE trial not to be the case: results showed that CBT and GET are not effective in the long term for ME/CFS patients. She also suggested that concerns around these therapies may be due to the competence of the practitioner and not the “treatments” themselves, that, “some failures could be caused by practitioners who are without the proper training in ME/CFS”. 

One study (the FINE study) may not prove conclusive. It is the nature of scientific advance that agreement may only be reached after a number of trials and debate.

7. Extreme caution was not applied in the original study proposal and the public and patients can have no confidence in the researchers that it will be applied in the execution of the study. Even given the researcher’s claim, albeit unsubstantiated, of the differences between adults and children, how can something that harms adults be “felt” to be less of a risk to children?

The REC did not agree with this view that the LP was inevitably harmful to adults. There is a lack of evidence that this trial is trying to address.

9.The data in the joint AfME and AYME report for the Inquiry only gives percentages, not the number of respondents who tried each intervention, which increases the unreliability of this data. There are only 3 choices for responses; helpful, no change and worse. The MEA data shows that 906 respondents had tried GET and 997 had tried CBT, whereas only 101 had tried LP. If it is accepted that survey data is unreliable, then should not the committee discount Esther Crawley’s defence of her proposal that LP was rated as faring better than CBT and GET in the APPG Inquiry into NHS Service Provision for ME/CFS?

The REC understood this but felt again that given the lack of any evidence, an RCT as proposed was the best way to resolve the issue

Yours sincerely

…..

Emails

Email dated 14 February 2011- AYME and SMILE Study

  1. As previously stated and published, the REC reviewed the information to be provided to those who may be recruited and were satisfied that no therapeutic claims were being made. This was re-emphasized in the second meeting.

4. As with other branches of research, it seems fair for patient groups to support trials that submit the therapies they promote to research to see IF they do, indeed, work

Email dated 8 February 2011 –  NRES Apology to Phil Parker

  1. This is incorrect. If you wish names, please apply to the research team

3. The trial is to determine IF the therapy works.

I understood / recall that they did

      5. Participation in the research will be based on discussion with the researcher (EC) and    

            the participant information sheet

      6. Not within the remit of considering this research

This was already considered by the REC

      7. As with this letter, we would agree that these are opinions, open to challenge, and one of  the best ways to do this is through a clinical trial, otherwise it remains a battle of untested opinion

(End)

 The above was in reply to our letter of 16th January 2011 – https://frownatsmile.wordpress.com/2011/01/16/response-to-ethics-service-review-of-smile-16th-jan-2011/

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NRES publishes lies about SMILE study – 1st April

1st April 2011

To: Joan Kirkbride <joan.kirkbride@nres.npsa.nhs.uk>

Cc: janet.wisely@nres.npsa.nhs.uk, “sally.davies” <sally.davies@dh.gsi.gov.uk>, “Bill.Davidson” Bill.Davidson@dh.gsi.gov.uk

Dear Joan,

Thank you for your mail of 16th March. I believe you may have again been misled by the SMILE research team. You said:

“1. It was never the intention that Alastair Gibson would provide research interventions and no change has been made since initial submission.”

In March 2010, this announcement was made on Alastair Gibson’s

Withinspiration website:

““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.”

As you are aware, Alastair Gibson is one of two LP traders named in the study outline. The other is Phil Parker. You have not explained what Gibson’s role was intended to be, and you are not able to name the LP traders who are involved with the direct interventions. I did as you advised, and wrote to ask the research team for this information, but have received no reply.

2. Thank you for confirming that NRES did receive the correct information about the ASA ruling against Alastair Gibson’s trading of The Phil Parker Lightning Process through “Withinspiration”.

You say: “The name was given incorrectly in the summary document provided to the SW2 REC.”

I assume you mean the summary document provided for the review meeting. This suggests that the committee that conducted the review meeting was not fully appraised of the facts of the case prior to the meeting. There were only two LP traders named as involved in the study: Alastair Gibson and Phil Parker. Both sell the Phil Parker Lightning Process. The ASA ruling was against the false claims of cure of disease by means of the Lightning Process. It is not therefore, substantially relevant to the ethical considerations of the study, whether it was Phil Parker himself or Alastair Gibson’s trading of the same product that was the direct subject of the ASA ruling. If this was simply a matter of using the wrong name, it begs the question why you deemed it necessary to publish such a fulsome apology to Phil Parker for the embarrassment caused him by this simple mistake, and why you did not point out that it was the other LP trader named in the study that was the subject of the ASA ruling, rather than referring to Alastair Gibson’s business as an “entity”.

In your apology to Phil Parker, you said:

“Mr Parker has confirmed that the complaint that was investigated by the Advertising Standards Authority (ASA) did not concern him but rather an entity called “WithInspiration” with whom he has no financial, employment or other interest. It is a private business managed by a registered Lightning Process Practitioner and he had no ability to influence the day to day management or marketing of this business. The complaint made and subsequent adjudication was not related to Mr Parker and he has never been the subject of any complaint investigated by the ASA or by trading standards.”

You had been in receipt of all the documentation and correspondence relating to SMILE and so you must have been aware that this is untrue.

As Alastair Gibson is a registered Lightning Process trader, Phil Parker does have financial and other interest in Alastair Gibson’s business and he does have an ability to influence Alastair Gibson’s marketing of the Lightning Process – I expect you have a copy of the Phil Parker Group Code of Ethics and are aware of the financial arrangements pertaining to LP practitioners’ trading of the LP. As the adjudication related to Alastair Gibson’s claims about the LP, and as Alastair Gibson is an authorised LP trader, it was, by definition, related to Phil Parker. It was also untrue that Phil Parker has never been the subject of complaint investigated by Trading Standards – you did not say you had been told this, you stated it as fact, yet you had been told that he was the subject of complaint, and you have been provided with evidence that a complaint against him was under investigation by TS at the time you made that statement.

You were not only publishing untruths, you were also asking members of the public to publicise those untruths, which you untruthfully said was in order to “reflect the correct position”.

3. You were sent our response to the minutes of the REC review meeting on 17th January – it is now 1st April. This is an unacceptable length of time to respond to matters which the REC should have taken into consideration originally, and which the NRES should have thoroughly investigated in preparation for the review. You have given no reason why you should take so long to consider the points raised, other than the length of the document.

4. I have been informed of your response to the news that Phil Parker and his associates, under the name of the Phil Parker Group, are currently the subject of investigation by Trading Standards and the Advertising Standards Authority. I believe you were sent the letter from the TS investigating officer in which he stated:

“I will also be making a complaint to the ASA on behalf of Hampshire Trading Standards to ensure that they cover all the areas that we have issues with – this will include their website and any YouTube videos TPPG, or its associates, have published.”

I gather you wrote:

“We note the statement that Lightening (sic) Practitioners have been willing to comply with the law when advised to do so and do not think there is any further action required by NRES at this time.”

This is an incredible statement for the NRES to make under the circumstances. You have said before that if new evidence is submitted then you will take that into account. You felt it necessary to issue a full apology for incorrectly stating that Phil Parker had been subject to a ruling by the ASA. You now have evidence before you that the Trading Standards investigating officer is sufficiently concerned about the “number of areas of TPPG (The Phil Parker Group) advertising methods which could mislead consumers” that he wishes to ensure that the ASA will cover all the areas that TS themselves “have issues with”.

It is totally irrelevant to the ethical considerations of this study whether or not the LP traders involved in this study will amend their advertising to comply with the law. The pertinent issue is that they are currently breaking the law and were doing so when children were recruited for the study. This means, as you have been told before, that the young people and parents/care-givers concerned were subject to promises of therapeutic benefit from the Lightning Process.

Moreover, I can confirm that Alastair Gibson did not amend the content of his website after the ASA ruling, as ASA’s remit did not cover website content at the time. This means that he did not act on the implication of the ASA ruling that his website was in breach of Trading Standard regulations, even though he knew he was named as involved in the study at that time and that research participants would be advised to read its content, which included reference to SMILE and a link to the details of the study on the Bristol University website. To be clear, his website was in breach of OFT, TS and ASA guidelines. To also be clear: Phil Parker’s own website and advertising material has also been in breach of these guidelines – which TS now confirm they deem to be the case currently – it is Phil Parker’s main LP website and his trading practices that have been the main focus of their investigation. So what you are, in effect, implying, is that it is acceptable for these traders to make false and unsubstantiated claims and to provide misinformation and promise of therapeutic benefit to research participants, provided they have been caught doing it by Trading Standards and have complied with any adjudication made against them, regardless of the ethics of the matter.

Myself and others, including organisations that represent a large number of people, have provided you with relevant facts and information that show clearly the reasons why it is neither safe nor helpful in scientific terms to proceed with this study. I believe I have been given information by the NRES which is untrue, and have beenrequested to publicise such information.

I have concerns with the apparent lack of due regard to the rights, safety, dignity and well-being of the child research participants and a lack of scientific rigour in the study proposal approved by the ethics service. This is not the standard of behaviour, professionalism and competency that the public expect from senior officials working for the NHS, and certainly not from the Ethics Service.

Yours sincerely,

(Patient Advocate)

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Trading Standards on Phil Parker Group and LP March 2011

Letter from Trading Standards Services on Phil Parker Group and Lightning Process

30th March 2011

(bold italics are the blog author’s)

This is an update as to the progress of your complaint regarding The Phil Parker Group (referred to as TPPG). Thank you for all the information you have provided and I have spent some time doing my own research and speaking to experts. Clearly this is a complex matter which involves a large number of businesses spread over the UK.

I agree with your view that there are a number of areas of TPPG advertising methods which could mislead consumers. Our main aim here to is advise businesses in order to get them to comply with the law in the quickest and most efficient way.
Having read your initial complaint letter I can see you are familiar with the Consumer Protection from Unfair Trading Regulations 2008 (referred to as the CPRs).

As you have pointed out there are a number of areas where TPPG may have made misleading actions and omissions which constitute breaches of this legislation. This being the case, Regulation 19 (4) of the CPRs compels us to:

…have regard to the desirability of encouraging control of unfair commercial practices by such established means as it considers appropriate having regard to all the circumstances of the particular case.

What this means is that we should consider established means when deciding how to enforce the CPRs. In this case the established means for advertising issues would be the Advertising Standards Authority (ASA). There are a number of reasons why the ASA would be best placed to initally deal with The Phil Parker Group, these are:

1) they have a national remit and can therefore adjudicate on businesses anywhere in the country. As we have previously discussed, there are Lightning Process practitioners all over the country. Therefore a national organisation would be best placed to deal with issues that cross local authority boundaries.

2) If the ASA adjudicate against one practitioner for displaying misleading information then they can easily apply the same adjudication to any other practitioner who displays the same information. This is unlike a criminal prosecution whereby each individual would have to be prosecuted for each individual offence. This will be particularly useful in instances where TPPG display information on their website that is replicated on many other websites.

3) Adjudications can be made public and the ASA can, if they so wish, publicise the fact that a business is refusing to comply with an adjudication. This is a very quick way to show a business may be doing something wrong without having to go to court. I have also found that the last ASA adjudication against a practitioner led to some significant changes on their website.

4) The CPRs can be fairly wide ranging and open to interpretation. The ASA codes are far more specific and make it easier to pinpoint areas where a business may be doing something wrong.

5) The ASA can ask a business to justify any claims they make. In a criminal prosecution we would have to prove beyond all reasonable doubt that the business was misleading consumers. Given the nature of some of the claims this could prove difficult to do.
As you may be aware internet advertising only became the remit of the ASA from 1st March 2011. I have been informed by them that they have received some complaints about this issue within the first week of March. Therefore the matter is currently under their consideration and we await any adjudication. I will also be making a complaint to the ASA on behalf of Hampshire Trading Standards to ensure that they cover all the areas that we have issues with – this will include their website and any YouTube videos The Phil Parker Group, or its associates, have published..

I have found from speaking to other Trading Standards departments and the ASA a number of Lightning Process Practitioners have shown a willingness to comply with the law when they are advised to do so. Therefore, at this stage I feel that ASA adjudications will be enough to make these businesses comply with ASA codes and CPRs. Should The Phip Parker Group refuse to amend their marketing to comply with ASA adjudications then we always have the option of criminal prosecutions.

I hope this makes sense and if you have any questions please do not hesitate to contact me.

Trading Standards Investigating Officer

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COMMENTS ON THE MINUTES OF SW2 REC REVIEW

COMMENTS ON THE MINUTES OF SW2 REC

7. Mr Parker has used the study to increase sales

No evidence has been provided that Mr Parker has specifically used this study to increase sales. [snip] The protocol and application clearly state that practitioners had been informed that they must make NO therapeutic claims on the basis of this study.

*On May 14th 2010, Phil Parker’s website – lightningprocess.com; carried this advertisement: “Breaking News. NHS and LP research collaboration. A new pilot study involving the LP and the NHS has been awarded £164,000 for research into the treatment of CFS/ME in children and adolescents.” (Link 1)

Phil Parker’s website currently states: (Links 2, 3)

“Phil Parker, designer of the Lightning Process said: “We are thrilled to have the opportunity to collaborate on this exciting and groundbreaking research with Dr Crawley and her team. It is vitally important that all interventions that could assist children with CFS/ME to return to school and improve their health are explored. We hope that this study is successful and leads to further research collaborations between the Lightning Process and specialist teams like Esther’s.”

On March 29th, 2010, (Link 4) and September 1st, 2010, (Link 5) the following statement was documented on Mr Alastair Gibson’s website:

“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.”

Mr Gibson also makes these unproven therapeutic claims: “If you are currently suffering from ME / CFS Chronic Fatigue Syndrome, and you are ready to make a big difference in your life, and take the step to recovery, then the Phil Parker Lightning Process ™ is here for you. The Lightning Process ™ is a training programme to enable you to take control of your life, it will give you the skills that you need to live a normal, healthy and positive life”, and under; “Lightning Process Courses for Children and Young People”; “Alastair Gibson has a proven track record of working with Children and Young People, [snip] (How do I know it works? Well, I suffered from ME for over 7 years and in only three days I got my life back!)” (Link 6)

As these are business websites promoting and selling LP, these announcements appear intended to exploit the NHS research in order to lend credence to their therapeutic claims for LP. This exploits not only the NHS but also the child participants and their guardians.

8. The complainants claim it is not appropriate to research children before work has been conducted in an adult population that can give consent

It was felt that respondents had selectively quoted from guidance about the acceptability to undertake research on children. The Committee accepted the researcher’s view that CFS/ME is different in children and adults and therefore results from research on adults cannot be extrapolated to children.

*“The complainants claim it is not appropriate to research children before work has been conducted in an adult population that can give consent”. This is not a ‘claim’ made by the ‘complainants’. This is a requirement embodied in Guidelines for Ethical Research by the MRC, GMC and others.

Dr Crawley’s ‘view’ is insufficient grounds to disregard Ethical Guidelines established for the protection of child participants.

Child participants and their guardians are entitled to their human rights and the protection of the law. The guidelines are unequivocal – adult research should precede child research whenever possible. Dr Crawley’s ‘view’ that adult and child CFS/ME are different is unsubstantiated and self-serving. It is not for ‘complainants’ to prove that adult and child ME are the same, it is for Dr Crawley to prove that they are not. If there were any substantial evidence to support Dr Crawley’s ‘view’, then neither the REC nor Dr Crawley would have had to rely on a ‘view’.

9. Risk

The Committee noted that the intervention was in addition to standard care. The ME association survey data seemed to suggest it is as effective, ineffective or harmful as many other current treatments. Evidence of the risk provided to NRES was anecdotal and of low evidential value, reinforcing the need for such a trial as this one. The Committee felt that there may be a slight risk of a child being worse after therapy (but equally a chance of improvement) and considered that they could withdraw at any time from the study if they wanted to. Supervision of the process was in place

* The ME Association survey data shows that 35% had no change with LP, 21% were made worse including 13% made ‘much worse’.

The minutes observe rather glibly that, “they could withdraw at any time from the study if they wanted to.” This observation demonstrates a disturbing lack of knowledge about CFS which indicates that the risks associated with the SMILE research have not been evaluated.

Simply withdrawing from either mental or physical activity does not protect people with CFS from suffering injury; and that injury can be severe and long lasting. This is due to the ‘hallmark symptom’ of CFS – Post-exertional Malaise. The Chief Medical Officer’s Working Group Report on CFS/ME (CMO 2002) states:

“Perhaps the prime indicator of the condition is the way in which symptoms behave after activity is increased beyond what the patient can tolerate. Such activity, whether physical or mental, has a characteristically delayed impact, which may be felt later the same day, the next day, or even later. This is followed by a recovery period, which again may last for days or even weeks. In some instances, the patient can sustain a level of activity for some time, but a cumulative impact is seen, with a setback after several weeks or more. The amount of activity that provokes increased symptoms is related to the severity of the disorder, and in some individuals is very modest. Delayed fatigue, postexertional malaise, or increase in other symptoms after activity can be helpful to make a diagnosis. However, the consequent variability in functional disability can make adaptation to the illness very difficult for the patient, and can be confusing to those around the patient or who assess them.”

The CMO report confirms that even minor exertion can lead to exacerbation of CFS symptoms, yet this may not be felt until later or much later making it difficult for the patient or ‘those around the patient’ to know when they need to stop an activity. The National Institute for Clinical Excellence (NICE 2007) Guidelines for CFS/ME requires the presence of Post-exertional malaise for a diagnosis of CFS/ME; “1.2.1.2 Healthcare professionals should consider the possibility of CFS/ME if a person has:- fatigue with all of the following features:- …characterised by post-exertional malaise and/or fatigue (typically delayed, for example by at least 24 hours, with slow recovery over several days)”

Assessment of the risks that accompany activity in people with CFS is not possible without understanding it’s ‘hallmark symptom’. If these factors specified in the CMO Report and NICE Guidelines have not been given due consideration then the risks of participation in the SMILE research have not been assessed.

Denham and Nelson (2002) explain why ‘Self Determination’ – the basis of Informed Consent, is not an applicable concept in child research because; “the purpose of parental permission is not self-determination but protection.”

Denham and Nelson conclude: “The burden of parental permission is to protect a child from assuming unreasonable and unjustified risks given his or her immaturity. The burden of independent committee review is to be sure those research risks occur within the limits established by the special protections for research involving children.” [emphasis added]

Therefore the fact that participants can withdraw from the research at any time does not provide any safeguard against injury to participants. This is especially so in view of the hopes and motivation that can be expected from participants, and the way that LP encourages trainees to ignore their symptoms and engage in normal activities. There is no data or criteria to discern which participants might benefit and which might be harmed by the LP; such as might be ethically derived from research involving consenting adults with the power of Self-Determination.

14. A lack of generalisability

The Committee considered that the researchers accepted that they would not be able to generalise from this to children who had severe ME that kept them at home. It would still provide data on other children with this condition.

*What criteria have the researchers and the Committee used to differentiate participants from those excluded from participation – other than whether they can leave home or not? If the research results are to be generalisable based on whether a ‘child with ME can leave their home’ or not, the results will be useless to patients and professionals because this measure has no scientific or medical meaning.

What steps have Dr Crawley’s team taken to prevent housebound children and their parents from attempting to participate. Some might undertake a desperate and possibly dangerous effort to participate; particularly those vulnerable families that could never afford around £700 to purchase the LP. Or is one to assume that any child that can be dragged, carried or wheeled to the venue is eligible for participation?

Q1: Is there anything you would like to say regarding your study?

Dr Crawley said that this research had the full support of children and families, indeed the impetus for starting it came from children and families and had the support of AYME. They started recruiting in September and this is well up to schedule. Dr Crawley said that it was a feasibility study and the Committee were content with this.

*Where did this “impetus for starting” come from; were the Committee even curious about this? If it did not originate from the SMILE research, then it is likely that it originated from either support group newsletters or lightning process advertising and the hard-sell typical of LP websites. In the prior case it is likely that those that are interested then investigated the latter. These generally follow a tried and tested formula for flogging unproven alternative remedies:

1. tell potential customers about their condition so that the seller appears knowledgeable

2. provide a plausible-sounding theory of how the remedy works

3. support the theory with scientific-sounding information

4. provide testimonials from delighted customers – raise hopes and play on potential customer’s vulnerability and desperation for help.

This format can be seen on the webpage of many alternative remedy seller on the internet.

The first contact with a potential research participant is considered to be the start of the Informed Consent process; therefore all information is required to meet the ethical standards of research. Coercion is prohibited. In the case of those providing the “impetus for starting”, if said impetus originated from exposure to LP websites then their Informed Consent is invalid because they are clearly coerced and have been subjected to claims and information that does not meet the requirements of ethical research conduct. All the information on the websites they have seen is positive and many of the claims unproven. No researcher is permitted to expose potential participants to such unbalanced and coercive information. For potential participants that have seen LP websites and/or been influenced by newsletter articles about ‘recovery’, their raised hopes must be redressed – not exploited.

Q5: The practitioner of the lightning therapy has no other allied professional qualifications. The Committee suggested that it might be beneficial to the research if the practitioner had external qualifications other than in Lightning therapy and was covered by a code of conduct?

Dr Crawley replied there is a geographical limitation to who can be chosen and that she has worked before with the Bath practitioner who is good. In addition, the children will remain under her care. Prof Gunnell pointed out that children will continue to be under the specialist service in both arms. As the Chief Investigator for the study Dr Crawley accepted responsibility for the activities of the research team and pointed out that in this feasibility study, all Lightning intervention sessions will be recorded and some observed.

*Are you sure that Dr Crawley can adopt legal responsibility for NHS research? I would have thought it was for Dr Crawley’s employers to choose whether or not they accept responsibility for unqualified people treating children that are NHS patients. Kindly confirm that the REC lawyer has checked this and/or that the NHS have consented to accept this responsibility.

REFERENCES

CMO. 2002. Report of the Chief Medical Officer’s, CFS/ME Working Group. [Online]. Available at: http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_4064945.pdf. Accessed March 2, 2011.

Denham E, Nelson R. 2002. Self-determination is not an appropriate model for understanding parental permission and child assent. Anesth Analg 2002;94:1049

NICE. 2007. National Institute of Clinical Excellence. CFS/ME Full Guideline. [Online]. Available at: http://www.nice.org.uk/nicemedia/live/11824/36191/36191.pdf. Accessed March 14, 2011.

LINKS (All accessed March 25th 2010)

1.http://replay.waybackmachine.org/20100514074048/http://lightningprocess.com

2.http://philparker.org/data/uploads/FINAL%20NHS%20CFS_ME_funding.pdf

3.http://www.philparker.org/data/uploads/Press%20pack%20for%20journalists.pdf

4.http://www.theoneclickgroup.co.uk/news.phpstart=3680&end=3700&view=yes&id=4954#newspost

5.http://meagenda.wordpress.com/2010/09/01/landmark-agreement-extends-asas-digital-remit-lightning-process-pilot-study-in-children/

6.http://replay.waybackmachine.org/20090228161254/http://www.withinspiration.co.uk/lightning_process_courses_children_young_people.php

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Report by NRES on Complaint Investigation SMILE trial – March 2011

From National Research Ethics Service, March 2011 –

Complaint investigation – SMILE Study

Complaint Lead – Dr Janet Wisely

March 2011

Key dates and actions

3rdMarch -Correspondence received by email to Joan Kirkbride

4thMarch -Forwarded as formal complaint (previous correspondence had been managed through NRES Standard Operating Procedures) and received by Complaint Lead, Dr Janet Wisely

4thMarch -Initial assessment to consider the scope of the complaint and appropriate policy

7thMarch -Acknowledgement of complaint and copy of NPSA complaint policy sent

22ndMarch -Interviews

25thMarch -Response sent

Background

The complaint received related to correspondence regarding a study given a favourable opinionby an NRES REC. Prior to the formal complaint the matter had been managed by Joan Kirkbride,supported by Hugh Davies and also in consultation with the National Research Ethics Advisors’Panel (NREAP), through NRES Standard Operating Procedures. The matter has been separatelyreviewed by the NREAP during the management of this process. (Please refer to the named list on page 5 for the positions of individuals.)

Nature of the complaint and scope of investigation

The complaint can be summarised into key areas:

Outside NRES remit and NRES / NPSA complaints policy:

o  A complaint against the Lightning Process itself. This complaint is outside of the remitof NRES.

o  A complaint against the SMILE study.  All research falling within the remit described inthe DH Governance Arrangements for Research Ethics Committees requires afavourable opinion from an NRES REC; in this case, it is accepted by all parties that a favourable opinion is in place. There are therefore no issues regarding research governance raised through the correspondence received. Wider issues regarding the study are outside the remit of NRES.

o  A complaint against NRES SOPs in that they do not allow an appeal against a favourable REC decision. This is a policy matter for NRES and the UK Health Departments. The NRES SOPs are prepared by NRES and formally agreed by the UKHealth Departments. The review of such policy is therefore outside of the NRES /NPSA complaints policy. However, given the role of NRES in preparing and seekingapprovals for these SOPs, comment is made on the appropriateness of policy within the context of NRES operation. The commentary and associated recommendations are conducted outside the remit of the formal complaint.

Within NRES remit and NPSA Complaints Policy:

o  A complaint against the REC decision – NRES Standard Operating Procedures (SOPs) do not allow for an appeal against a favourable REC opinion. A REC may review its opinion on a study at any time (as described in SOPs). Under the NPSA Complaints Policy, investigation is required to determine if the standard and quality of services provided in managing the correspondence received on the study were handledappropriately, and to further determine if the matters were managed in line withinagreed procedures, i.e. NRES SOPs and NRES Complaints Policy.

Previous role of NRES Director

As NRES Director, I had previously been briefed on the correspondence received on the study,had supported the decision to review as new information to REC under standard operatingprocedures and had formally requested the NREAP to provide guidance to NRES on the matter.I had no involvement in the decisions made on the study. I concluded that, although I hadprevious knowledge of the matter and some previous involvement, I was still the most appropriate person within the NRES team to complete the complaint investigation. Throughout the investigation previous knowledge of relevant events is declared.

Complaint investigation under NPSA Complaints Policy

In reaching the conclusions detailed below, interviews were held with Joan Kirkbride, HughDavies, Andrew George and Charles Warlow alongside a review of available documentation.The key issue was to determine if matters had been managed appropriately through the available policies – NRES SOPs and NRES Complaints Policy.Appropriate NRES policyThe investigation revealed that the correspondence received had been managed through the NRES SOPs, these allow a REC to review a decision made in light of new information. There was no evidence to support that consideration had been made of the use of the NRES Complaints Policy but, as attached, it is clear in this that it is designed for use by applicants who are unhappy with a REC decision, not a third party. The findings are therefore that the appropriate policy option – NRES SOPs – was taken.

Management through SOPs

The SOPs option was taken and information was referred on to the REC who reconsidered the favourable opinion and confirmed this at a quorate meeting. In this respect all matters were managed through described SOPs. In addition, the views of the NREAP were sought to support the process. This is not described in SOPs but the support of the panel to NRES in such mattersis covered generally within the panel terms of reference, although for concerns of this naturenot specifically stated.

Management of correspondence

Large volumes of correspondence were received and Joan Kirkbride and Hugh Davies undertookto reply in detail to this correspondence. If any criticism is to be made, it could be the extent towhich they undertook to reply in detail to what was becoming increasingly repetitive and potentially vexatious correspondence. This was clearly done with good intention to be supportive and helpful. In hindsight, it may have been helpful to have recognised that the NRES process had reached an end sooner than they did.

The pattern of correspondence overall on the study would suggest that responses to previous correspondence was not being fully considered before further letters were sent, and the letter which prompted the formal complaint suggested that there was no policy through which the process had been handled, which is surprising given the previous correspondence on the matter.

Conclusions

The NRES Complaints Policy does not cover complaint or appeal against a REC decision by a third party. However, the NRES SOPs, whilst not providing an ‘appeal’ by a third party, do allow for the reconsideration of an ethical opinion in light of new information. This route wasfollowed, and followed appropriately as described in SOPs. Additional support was provided bythe NREAP. Although this is not described in SOPs, the support is in line with the agreed terms of reference of the NREAP.

The complaint is not therefore upheld.

Recommendations

1. The NRES Complaints Policy is updated to make it explicit that the policy is not for use for complaint by a third party against a REC decision, i.e. that it is as is currentlydescribed a complaint policy for applicants and study sponsors.

2. The NREAP terms of reference to be reviewed to make availability of the Panel to support NRES on matters relating to complaints and concerns more explicit.

3. NRES to consider development of guidance for operational team on management of correspondence from third parties.

Review of the NRES Standard Operating Procedures and provision for ‘appeal’ against a REC favourable opinion

In reaching the recommendations detailed below, conversations were held in addition to those for the formal complaint investigation, with David Neal and Bill Davidson.

The Governance Arrangements for Research Ethics Committees (GAfREC) are DH policy, as partof the Research Governance Framework for Health and Social Care. GAfREC requires that RECsreview decisions in light of new information, and this information may be information that comes to light after a REC decision or information that is a product of the conduct of the study, such as safety reports. SOPs provide for the implementation of this policy, allowing wide discretion for a REC to review its opinion of a study at any time. GAfREC also allows for furtherreview by a second REC when a REC gives an unfavourable opinion on an application, i.e. anappeal. SOPs set out a formal appeals procedure which implements this policy. There is noprovision in GAfREC for appeal by third parties against REC decisions, and accordingly this is not included in the SOPs.

In considering the appropriateness of this policy, it is worth noting what a favourable ethicalopinion means. It is one part of an approval process within the Research Governance Framework and when all required approvals are in place this gives permission for participants tobe invited to take part in a study. Participants may of course decline. The REC will look carefully at the planned consent process, including information to be provided about the study, opportunity to ask questions, independent sources of advice, time for reflection and also the availability of a complaint process for participants, including those who decline to acceptinvitation to take part in a study. In this context, it is difficult to see the role of an appeal process against a favourable opinion, and concern was expressed by those interviewed on the appropriateness of this option, with one respondent commenting that it would inappropriatelyinterfere with the REC / researcher / participant boundaries and relationships.

Conclusions

NRES SOPs are fully compatible with DH policy as described in Governance Arrangements for Research Ethics Committees. These allow for appeal by applicants or sponsors against unfavourable opinions and for RECs to review decisions in light of new information. No review of SOPs is required to ensure consistency with DH policy and none of those interviewed as part of the review considered changes of DH policy to allow appeal by third parties to be appropriate, and concern was expressed that it would be inappropriate.

Recommendation

No further action is required.

Named individuals

Andrew George   Chair, National Research Ethics Advisors’ Panel

Bill Davidson    Research Governance Manager, Department of Health

Charles Warlow   National Research Ethics Advisors’ Panel – Member

David Neal   NRES, Deputy Director (Policy)

Hugh Davies   NRES, Ethics Advisor

Joan Kirkbride   NRES, Head of Operations

Links

Governance Arrangements for Research Ethics Committees: http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4005727NRES

Standard Operating Procedureshttp://www.nres.npsa.nhs.uk/news-and-publications/publications/standard-operating-procedures

Attached

oSMILE investigation interview notes

oNRES Complaints Policy

oNPSA Complaints Policy

National Research Ethics Advisor’s Panel

As described on NRES website

Background

NRES was asked by four UK Health Departments, through the United Kingdom Ethics CommitteeAuthority (UKECA) to establish a central advisory panel. The objective of the panel is to helpwith the strategy, quality assurance and service development of RECs and improve the research environment in the UK. This panel will offer leadership in matters relating to policy, training, ethical arguments anddebates, stakeholder engagement and other allied matters. It is independent but hosted withinNRES and a resource available to all DH funded UK RECs and their appointing authorities.

Membership

A panel of 12 advisors, plus the NRES Ethics Advisor, Dr Hugh Davies, has been appointed. Members have appropriately senior experience and expertise from different and relevant backgrounds, including a past or present REC members and chairs.

Members have one or more of the following expert backgrounds including a past or present RECmember or chair:

Clinical research involving patients

Clinical research involving healthy volunteers

Public health research

Social science

UK Ethics service

Patient and public involvement

The pharmaceutical industry

The panel meet monthly in London or occasionally elsewhere in the UK, as appropriate. Membership and terms of reference of the Panel will be reviewed on an annual basis. The roleof an NREA panel member involves a minimum time commitment of around 1 – 2 days permonth to include some preparation time for the meetings.

Terms of reference of the NREA Advisors’ Panel:

Arbitration on ethical debates and disagreements arising from appeals byapplicants and from within RECs.

Oversight of the ‘shared ethical debate’ external quality assessment program for RECs.

Oversight of NRES training programmes and training delivery as appropriate.

Oversight of personal development programmes for REC chairs.

Advice to NRES or RECs regarding alleged fraud or misconduct in research.

Provision of guidance on governance issues and legal issues.

Support for NRES with business planning and strategy.

Support for NRES with relationships with RECs and support to RECs in their relationships with NRES.

Support for NRES with relationships with other regulators, research funders, universities, professional bodies and industry including AREC.

Support for NRES with patient and public involvement in research.

Support for NRES with media enquiries and response to news items or journal articles about RECs.

Representing NRES at events and conferences.

Facilitating NRES events.

Chairing ad hoc advisory groups and working parties as appropriate.

The National Research Ethics Advisors’ Panel may be contacted via the panel Secretary, Clive Collett (clive.collett@imperial.nhs.uk).

* * * * * * * * * * *

Abstracts from NREAP minutes

The NREAP minutes are routinely published on the NRES website.

Abstracts are included from meetings in December 2010 and February 2011:

December 2010

7. Submissions from the ME Association and others to NRES concerning the ‘SMILE’ study

Received for discussion:

The ME Association and the Young ME Sufferers Trust joint statement

NRES response letter

Notes written by Hugh Davies in early response

IRAS application for the ‘SMILE’ study

The ME Association has raised concerns over a study of ME in young people that was recently approved by a REC. The panel were asked for comments/advice on the broader ethical issues and the actions proposed by NRES:

“…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.”

The panel were supportive of the proposed NRES action put forward to deal with the concerns raised by the ME Association and others. It agreed that the main REC should be asked to review its favourable opinion in the light of new information (as per current NRES SOPs). The panel were in broad agreement with the preliminary notes written by HughDavies in response to complaints made about the SMILE study. However, the panel feltthat in reviewing its decision the REC involved should limit itself to considering only therelevant new information regarding the study itself and not to consider allegations whichwere outside of its remit or competence to comment upon.

The panel stated that it was important to conduct impartial research into ME and that, where appropriate, it was equally important to ensure the benefits of research are extended to children in line with existing guidelines. It was noted that in the SMILE studyparticipants were not being deprived of current care and the research question was theeffectiveness of the additional tool which the study was designed to evaluate.

Agreed: The panel agreed and endorsed the proposed NRES action

February 20116.

The SMILE Study: Charles Warlow

Received for discussion:

Report for the National Research Advisors’ Panel – Charles Warlow

JW and HD left the room whilst the panel discussed this item.

Following the verbal report from CW, the panel agreed that:

Whilst the panel did not feel that any “material issues” had been raised tocategorically require a second review by the main REC it was felt that NRES had acted appropriately and reasonably in asking the main REC to review its favourable opinionin the light of the ‘new information’ (in line with NRES SOPs). Whilst the panel were not in a position, nor had the remit, to comment upon the initialand subsequent review provided by the main REC, they considered the REC’s opinionsto be entirely appropriate.

If any further studies involving the lightning process are to be reviewed by an NRES REC then the panel felt it would be appropriate for the main REC involved to be appraised of the history of the ethical review of the SMILE study.

The panel supported the NRES operational view that the correspondence receivedafter the REC meeting, in response to the REC decision not to suspend the ethical opinion, does not raise new issues that require a further review by the REC at this time.

DRAFT  March 2011

JW explained that there had been a formal complaint made to the NPSA regarding the handling of the review of the favourable opinion for the study by the main REC followingnew information. JW pointed out that the complaint focused on the review of the “appeal” but that the second review carried out by the main REC was not an “appeal” but rather a review of its favourable opinion in the light of new information as per NRES SOPs:

“9.86 The main REC may review its favourable ethical opinion of a study at any time. Inparticular, this might be prompted by safety reports, progress reports or any other information received about the conduct of the study. The Chief Investigator or sponsormay ask the main REC to review its opinion, or seek advice from the REC on any ethical issue relating to the study.” (Standard Operating Procedures for Research Ethics Committees – Version 4.1, May 2010)

The panel expressed their concern that research into ME was becoming increasingly difficult for researchers and that consequently less research was being undertaken in this important disease area. Given the potentially vexatious nature of correspondence andcomplaints, it was agreed that AG should contact ‘Understanding Animal Research’ to explore areas of common ground in handling correspondence with regard to conductingresearch in contentious areas.

(End)

NRES complaint investigation interview notes are here – https://frownatsmile.wordpress.com/2011/03/25/nres-complaint-investigation-smile-final/

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Dr. Esther Crawley – Bristol University Staff Details

Bristol University Centre for Child and Adolescent Health – Staff Directory – People details (as at March 2011 – link now broken)

Dr Esther Crawley

BA(Hons), BM BCh(Oxon), PhD(UCLond)

Consultant Senior Lecturer

Oakfield House
Oakfield Grove
Clifton
Bristol
BS8 2BN
UK

Fax Number: (0117) 33 14088
Telephone Number: (0117) 33 14099
Email: esther.crawley@bristol.ac.uk

List of publications (IRIS publications database – (as at March 2011 – link now broken)

Qualifications

BA (Hons.), BM BCh, MRCP(UK), FRCPCH, PhD

Current Research and Interests

The paediatric CFS/ME research team is based at Bristol University and is currently running projects looking at:

  • The Epidemiology of CFS/ME in children
  • Prognosis and outcome of children with CFS/ME
  • Impact of CFS/ME on families
  • The prevalence of undiagnosed CFS/ME in children
  • Predictors of fatigue and CFS/ME in the Avon and Longitudinal Study of Parents and Children (ALSPAC) as well as other projects.

Dr Esther Crawley was the first to publish that CFS/ME exists in children under 12; that children with CFS/ME don’t go to school because they are unwell not anxious and that young people with CFS/ME have significant problems with memory and concentration.  In December 2008 Esther was awarded the National Institute of Heath Research Clinician Scientist Fellowship bringing the research money raised in the last two years to over £1.25 million.

Teaching

In 2008-09 Esther provided over 20 training workshops to Paediatricians, neurologist Physiotherapists as well as, Child and Adolescent Mental Health Services (CAHMS) and Social Service Departments as well as providing  inset day training  and over 10 twilight  sessions  for schools. She has written one Chapter about the management of CFS/ME (Recent Advances in Paediatrics 2008) and co-authored Self Assessment Questions for Paediatrics and Child Health (08), as well as supervising psychology doctoral students and three clinicians in their research projects.

Profile

Esther is a Senior Lecturer at the University of Bristol and a Consultant Paediatrician with a special interest in CFS/ME. She is the clinical lead for Bath specialist CFS/ME service for children based at the Royal National Hospital for Rheumatic Diseases in Bath which currently provides assessment and treatment for over 250 children and young people per annum.

Esther completed her medical training in Oxford, and then worked in Birmingham and Liverpool before doing her PhD at University College London and Great Ormond Street Hospital. She moved to Bristol and Bath to set up the paediatric CFS/ME service.

Esther is a medical advisor to the Association of young people with ME, and is Chair of the British Association for CFS/ME (BACME). She set up the Royal College of Paediatrics and Child Health special interest group for CFS/ME. She was on the guideline development group for the NICE guidelines published in August 2007 and is currently part of the MRC CFS/ME Expert working group.

She currently lives in the centre of Bristol with her two young children, when they are not enjoying the snow or surf.

(From:  Bristol University Centre for Child and Adolescent Health – Staff Directory – People details – as at March 2011 – link now broken)

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Complaint investigation by NRES – Interview Notes – 22nd March 2011

Complaint investigation – SMILE Study

SMILE investigation – interview notes

All interviews held by telephone on 22ndMarch 20111.

Bill Davidson (BD)

JW explained briefly the background to the study and the formal complaint that had beenreceived. BD confirmed he was aware of the study because of correspondence that had also beensent to the DH. It was agreed that as BD had had no involvement in the NRES handling of the study and associated correspondence there was no role for BD in terms of the specific complaint and specific study. The purpose of the interview with BD was to explore, in principle, the issues raised regarding SOPs as they are written, not to make judgements about whether they had been followed.

JW asked if BD considered the current SOPs were compliant with GAfREC – current and the updated version that is scheduled for release.

BD confirmed SOPs and GAfREC were compatible. GAfREC allows that new information can be any information from any source – safety reports for example or other information received as aproduct of the ongoing research, as well as information from any route that may have beenavailable at the outset but was not disclosed, for example fraudulently or inadvertently.

JW asked BD his views on whether NRES should consider revision to SOPs to allow an appeal against a favourable opinion?

No, SOPs allow for consideration of new information as described and BD did not support concept of ‘appeal’ but agreed that NRES need to consider how SOPs work in practice and in light of experience may wish to reflect on guidance and process for reviewing new information afteroriginal decision.

JW explained that in the SMILE case NRES had used the NREAP as a further support to this processand asked if BD would agree that this additional assurance process should be formally capturedfor any such future cases?

Would urge caution of describing in SOPs but agreed with suggestion that NREAP Terms ofReference (ToR) could expand on current wording to make it clearer that advice may be provided in such cases, both NRES management and RECs.JW asked if there was anything else BD would like to add?BD had nothing to add and the meeting was closed. The notes have been agreed by BD.

2. Hugh Davies (HD)

JW explained that a formal complaint had been received on the SMILE study and that this was being managed through the NPSA Complaints Policy. JW explained the remit of the ComplaintsPolicy, which could not judge ethical decisions or management decisions. Similarly, any complaint about the actual intervention was not within the remit of NRES. But an investigation was requiredto determine if the standard and quality of services provided in managing the correspondence received on the study were handled appropriately, and to further determine if the matters weremanaged in line within agreed procedures, i.e. NRES SOPs and NRES Complaints Policy. JW explained that the key element of the complaint was the SOPs themselves, regardless of whether or not they had been followed and she was therefore exploring this issue as part of her review; even though she would make quite clear this was a policy issue that sat outside of the complaint process itself.

JW asked HD to summarise his role in the process and asked if there was anything else that hadnot been documented in his report and correspondence that he would want noted or taken intoconsideration?

HD explained that as Ethics Advisor he had supported Joan and the committee in managing the issues that had been raised, that he had not been particularly mindful of the process as he saw this as Joan’s role but he had been anxious that issues raised had proper consideration and review. He and Joan worked together in preparing responses to correspondence. HD reflected the comment from the committee as he had left when they thanked him for not telling them how to think, theyhad been able to make their own decisions and judgments. He felt he had usefully been able to support the committee by summarising issues and pointing them to relevant guidance.

JW asked HD his views on whether NRES should consider revision to SOPs to allow an appeal against a favourable opinion?

No, not sure what this would add.

JW asked HD if he considered the current SOPs required any revision to the process presentlydescribed which allow for a REC to reconsider an opinion in light of new information?

HD felt current SOPs had allowed for the issues to be considered, and had given the issues a fairreview. He added that SOPs even allowed them to go the ‘extra mile’ in acknowledgement of the volume of correspondence that had been received.

JW referenced that in the SMILE case NRES had used the NREAP as a further support to this process and asked if HD would agree that this additional assurance process should be formallycaptured for any such future cases?

Think this would blur boundaries to include in SOPs, agreed with the suggestion that NREAP ToR could be updated though to make the role clearer in supporting both NRES staff and RECs in such difficult cases.

JW and HD acknowledged that JW had herself suggested the referral to NREAP.

JW asked if there was anything else HD would like to add?

Just to acknowledge the amount of time, huge volume of information and correspondence and had tried to reply as rapidly as possible, but it had been very difficult with the volume received.Also needed to note that had worked with investigator and sponsor as well in dealing with the issues and providing responses.

The meeting was closed. The notes have been agreed by HD.

3. David Neal (DN)

JW explained briefly the background to the study and the formal complaint that had beenreceived which was being managed through NPSA Complaints Policy. DN confirmed he was aware of the study because of briefings that had been made at NMG (NRES Management Group) and the consideration by NREAP. It was agreed that as DN had had no involvement in the NRES handlingof the study and associated correspondence there was no role for DN in terms of the specific complaint and specific study. The purpose of the interview with DN was to explore, in principle, the issues raised regarding SOPs as they are written, not to make judgements about whether theyhad been followed.

JW asked if DN considered the current SOPs were compliant with GAfREC – current and the updated version that is scheduled for release.

Yes, SOPs are designed to implement GAfREC and go beyond GAfREC with respect to otherlegislation such as clinical trials regulations. For the purpose of review of opinion they allow appeal by applicants against an unfavourable opinion and review of a favourable opinion at any time in light of reports received by the REC, reflecting the policy set out in GAfREC.

JW asked DN his views on whether NRES should consider revision to SOPs to allow an appeal against a favourable opinion?

No, issues are covered through existing GAfREC and SOPs. Need to note that participants are free to decline to take part in a study. The REC will review the informed consent procedure and will consider information given, opportunity to ask questions and time to reflect on decision as part of that consent process. A complaints procedure will also be in place for participants that are concerned with the consent process or with ongoing involvement within the study.

JW asked DN if he considered the current SOPs required any revision to the process presentlydescribed which allow for a REC to reconsider an opinion in light of new information?

No not specifically, although generally SOPs are kept under review.

JW explained that in the SMILE case NRES had used the NREAP as a  further support to this processand asked if DN would agree that this additional assurance process should be formally captured in SOPs for any such future cases?

Not a specific role, we have maintained the appropriate boundaries between RECs and NREAP which is not an ethics committee and this is important. NREAP is just one source of possible advice to RECs and others may be better placed to provide expert support or advice in different circumstances. However, a general statement in the introduction to SOPs describing the NREAPand referring to the terms of reference for the Panel in more detail may be helpful. It may also be worth consideration in the NREAP ToR giving a role to respond to public concerns.

JW asked if there was anything else DN would like to add?

None

The meeting was closed. The notes have been agreed by DN.

4. Andrew George (AG)

JW explained briefly the background to the study and the formal complaint that had beenreceived which was being managed through NPSA Complaints Policy. AG confirmed that heagreed with the NREAP assessment that SOPs had been followed. He accepted, though, that there was a requirement for JW, through NPSA Complaint Policy, to review if the standard andquality of services provided in managing the correspondence received on the study were handledappropriately, and to further determine if the matters were managed in line within agreedprocedures, i.e. NRES SOPS and NRES complaints policy.

JW explained that the key element of the complaint was the SOPs themselves, regardless of whether or not they had been followed and she was therefore exploring this issue as part of her review, even though she would make quite clear this was a policy issue that sat outside of the complaint process itself.

JW asked AG if there was anything in addition to the NREAP noted comments which he wouldwish to add in terms of the NRES management of the issue from his perspective, and the role of the NREAP?

No

JW asked if AG considered the current SOPs were compliant with GAfREC – current and the updated version that is scheduled for release.

Yes

JW asked AG his views on whether NRES should consider revision to SOPs to allow an appeal against a favourable opinion?

Consider, yes, but not required as current process allows appropriate review and a change to an‘appeal’ process could be problematic for potential vexatious approaches and a third party accessto appeal would interfere inappropriately with the REC / researcher / participant relationship.

JW asked AG if he considered current SOPs required any revision to the process presentlydescribed which allow for a REC to reconsider an opinion in light of new information?

No, pleased that the current process allowed enough flexibility for the matter to be reviewed,when really the new information was more a weight of opinion.

JW said that NRES had found the access to NREAP for support in the SMILE case had beeninvaluable and asked if AG would agree that this additional assurance process should be formallycaptured for any such future cases?

NREAP is not a judicial body, any described role needs to be kept as advisory and Terms of Reference is the appropriate place not SOPs. Need to be clear that NREAP is not constituted as a REC and does not have a role to supersede decisions made by RECs.

JW and AG acknowledged that JW herself had made the referral of the matter to NREAP.

JW asked if there was anything else AG would like to add?

No

The meeting was closed. The notes have been agreed by AG.

5. Charles Warlow (CW)

JW explained briefly the background to the study and the formal complaint that had beenreceived which was being managed through NPSA Complaints Policy. CW confirmed that onrequest from NRES he had undertaken a comprehensive review of the issues raised and presented these to the NREAP, and that he agreed with the NREAP assessment that SOPs had been followedand also that he thought it important that the study should proceed.

JW and CW acknowledged that JW herself had asked CW to undertake this review for the panel, but that she (and HD) had left the room for the panel discussion.

CW accepted, though, that there was a requirement for JW through NPSA Complaints Policy toreview if the standard and quality of services provided in managing the correspondence received about the study were handled appropriately, and to further determine if the matters were managed in line within agreed procedures, i.e. NRES SOPS and NRES Complaints Policy.

JW explained that the key element of the complaint was the SOPs themselves, regardless of whether or not they had been followed and she was therefore exploring this issue as part of her review, even though she would make quite clear this was a policy issue that sat outside of the complaint process itself.

JW asked CW if there was anything in addition to the NREAP noted comments which he wouldwish to add in terms of the NRES management of the issue from his perspective, and the role of the NREAP?

No

JW asked CW his views on whether NRES should consider revision to SOPs to allow an appeal against a favourable opinion?

No, really cannot see how it can be appropriate for a third party to have access to appeal againsta favourable REC decision. Need to be able to review new information as we did, but not appeal. Concerned that this would be inappropriate and could be used to be vexatious.

JW said that NRES had found the access to NREAP for support in the SMILE case had been invaluable and asked if CW would agree that this additional assurance process should be formallycaptured for any such future cases?

As an advisory role in ToR, yes, could be more specifically described.

JW asked if there was anything else CW would like to add?

No

The meeting was closed. The notes have been agreed by CW.

6. Joan Kirkbride (JK)

JW explained that a formal complaint had been received on the SMILE study and that this was being managed through the NPSA Complaint Policy. JW explained the remit of the complaint policy, which could not judge ethical decisions or management decisions. Similarly, any complaint about the actual intervention was not within the remit of NRES. However, an investigation wasrequired to determine if the standard and quality of services provided in managing the correspondence received on the study were handled appropriately, and to further determine ifthe matters were managed in line within agreed procedures, i.e. NRES SOPS and NRES Complaints Policy. JK accepted that as Head of Operations she was responsible for ensuring the matter hadbeen managed through SOPs. She said it had been a difficult issue to manage, with huge volumes of correspondence which had also been quoted and put into the public domain. JK said it was acampaign against a study the like of which she had not had to manage before.

JW and JK acknowledged that JW had provided advice during the process, and had reviewed some correspondence but that JK had prepared all responses, liaised with all parties herself and JW hadnot been directly involved until JK referred the matter to her as a formal complaint, as required inNPSA Complaints Policy.

JW explained that the key element of the complaint was the SOPs themselves, regardless of whether or not they have been followed and she was therefore exploring this issue as part of her review, even though she would make quite clear this was a policy issue that sat outside of the complaint process itself.

JW asked JK to summarise her role in the process and asked if there was anything else that hadnot been documented previously that she would want noted or taken into consideration?

JK confirmed she had managed the issue through SOPs and had nothing further to add at that stage.

JW and JK acknowledged that it had been JW who had suggested that the NREAP also beconsulted. JW asked JK if she had considered managing the issue through the NRES Complaints Policy?

No, she considered the issue as a concern from a number of quarters about a REC decision and as such managed this as information for the REC to consider – as per SOPs. She added that in this respect it did not occur to her to manage it in any other way.

JW asked if JK felt the NRES Complaints Policy should cover such issues?

No, the policy is correct in being for applicants.

JW asked JK if she felt the matter could have been referred through the NPSA Complaints Policy sooner, accepting that JW herself could have provided this advice?

It was difficult because at each step you could not appreciate what was coming next. The initial request had come in through FOI but even in hindsight the SOP route was the appropriate one. It was only when a letter challenged my own actions, rather than the thoughts and assumptions of the REC, that I immediately referred through the complaints procedure.

JW asked JK her views on whether NRES should consider revision to SOPs to allow an appeal against a favourable opinion?

No, I don’t think so. It would seriously undermine the REC position and the new information route is there to be used. Even if we had had concerns with process in light of new information, we haveoptions available if required to co-opt members or give further advice to the REC, potentially with support of NREAP so think SOPs allow us to manage appropriately.

JW asked JK if she considered current SOPs required any revision to the process presentlydescribed which allow for a REC to reconsider an opinion in light of new information?

SOPs worked fine, could maybe look at detail of wording in a general review but nothing fundamental needs changing.

JW asked if the use of NREAP as a further support to this process had been helpful and asked if JKwould agree that this additional assurance process should be formally captured for any suchfuture cases?

The support was helpful, a role in SOPs would be a step too far for an advisory panel, but more detail in ToR about role in supporting NRES managing concerns could be helpful.

JW asked if there was anything else JK would like to add?

A considerable amount of work and on reflection we could have been more organised as an operations team in dealing with the volume of correspondence if we could have predicted howmuch the issue was going to grow. We perhaps need some operational guidance to ensure thingsare pulled into a central response sooner in such cases. We kept the SHA informed as theappointing authority, operational guidance would ensure this link in.

The meeting was closed. The notes have been agreed by JK.

Janet Wisely

Director, National Research Ethics Service

22nd March 2011

(End)

NRES full response / report on their investigation of complaint is here – https://frownatsmile.wordpress.com/2011/03/25/nres-complaint-investigation-smile-final/ 

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Correspondence with CMO March 2011

Letter from CMO 11th March 2011

Dear Jo

I refer to your related emails of the 16th February at 16:26, 16:28
and 16:38 respectively.

Thank you for copying to me your correspondence with Joan Kirkbride,
head of operations for the National Research Ethics Service (NRES).

I cannot comment on the substance of the information you supplied to
Joan Kirkbride in respect of the research ethics committee review of
the “SMILE” study proposal. To command confidence, research ethics
committees and their decisions are, and must be seen to be,
independent of Government and free of political influence.

I can tell you that I understand the relevant research ethics
committee reviewed its opinion of the “SMILE” study proposal in light
of subsequent information, in accordance with NRES standard operating
procedures agreed by the UK health departments and the UK Ethics
Committee Authority, and that its opinion remains favourable.

Ethical research contributes to the scientific evidence about the
safety and efficacy of treatments and care. The study in question is
therefore expected to help show objectively whether the “Lightning
Process” is a safe and effective way of managing myalgic
encephalomyelitis — or whether it is not. I look forward to its
findings with interest.

Best wishes
Sally

sent by Caron Biart

Professor Dame Sally C Davies
Chief Medical Officer
Department of Health
London
Tel (R&D) 020 7210 5982

Reply to CMO 16th March 2011

Dear Sally,

Thank-you for your mail of 11th March.

I fully appreciate that it is not appropriate for you to comment on the letters I forwarded to you for your information. I was aware that the ethics committee had reviewed its decision, and sent Joan Kirkbride a detailed response to the minutes of the ethics committee meeting on 17th January, with a total of 90 co-signatures – it may be read here:

https://frownatsmile.wordpress.com/2011/01/16/response-to-ethics-service-review-of-smile-16th-jan-2011/

I agree with you that ethical research contributes to scientific evidence about the safety and efficacy of treatments and care, but this study fails on all counts as, a) it is not scientific in design or method, b) the Lightning Process is not a treatment, nor even a therapy – it is advertised as a training programme and the trainers are not medically qualified, c) telling children with myalgic encephalomyelitis to ignore their symptoms and to deny that they are ill cannot be described as care, d) the SMILE study is unethical – Dr. Crawley did not present adequate reason why this product should be tested on children before testing it on adults; her assertion that ME is different in adults and children is widely disputed and scientific evidence shows the contrary, and SW2REC was not given the full and correct information it needed to approve the study originally. This information was subsequently sent in by a number of individuals and organisations, but unfortunately, NRES did not properly or accurately assess the new evidence received – and so again came to a misguided conclusion.

I realise that your position is that it is not for politicians to intervene in such matters, and I believe that a formal complaint against NRES is now in progress. However, your final comment on the subject strongly suggests that you support this study, rather than taking an impartial stand at this stage, and I wonder whether you would wish to revise your comments, once you have read all the evidence and correspondence about The Lightning Process and the SMILE study.

For example, you say, “The study in question is therefore expected to help show objectively whether the “Lightning Process” is a safe and effective way of managing myalgic encephalomyelitis — or whether it is not.”

Are you aware that there are no objective outcome measures for this study and that this is one of the major concerns about it?

You may not be aware that the effectiveness of the Lightning Process relies on participants denying that they are ill. Are you sure that you believe this may be a safe way to manage neurological disease? Do you feel comfortable condoning the use of children to test the safety of this product before it has been tested on adults, given that it is not specifically designed for paediatric use and that it is advertised as being equally effective for adults and children? Would you not feel more at ease if the research were carried out on adults, before putting sick children at further risk?

Please bear in mind that the lead researcher, Dr. Crawley, did not disclose the risks to the children in her study proposal – this has been added to the patient information following the ethics committee’s review of its decision, prompted by the evidence provided by members of the public.

I realise that you will not wish to comment on the conduct of Dr. Crawley in this matter, as that is beyond your immediate control. However, it is clear that, as a doctor employed by the NHS, her involvement in this study is a matter of very serious concern. She did not provide NRES with the full information they needed to come to an informed decision in her original proposal, and unfortunately, NRES has relied on Dr. Crawley’s assurances in order to uphold their decision. NRES was also reassured by the involvement of AYME, but Dr. Crawley is AYME’s medical adviser. The unquestioning loyalty to their medical advisor, of AYME’s CEO, Mary-Jane Willows, is clear from her letter to the Ethics Committee dated 1st December in defence of Dr. Crawley. AYME’s role is intended to be as independent overseers of the study, so emotive support of the lead researcher, together with a clear bias in favour of The Lightning Process, is not appropriate.

I realise that the various publicly-funded individuals and organisations involved with this study have their relative responsibilities that you would not wish to interfere with at a political level, but as Chief Medical Officer, you are seen, by the voting public, to be ultimately responsible for what happens to these children while under the care of the NHS. You may not be in a position to take direct action to have this study stopped, as the weight of objective evidence shows that it should be, but as you have now been given full disclosure of the facts, risks and concerns relating to this study by members of the public – and by the other ME charities that have no vested interest in this research – I hope that you will revise your comments of approval of this study, which will be in the public domain.

You will see from the correspondence that the NRES’ attention was drawn to research that was published after they had originally granted ethics approval of SMILE.

Biochemical and Vascular Aspects of Paediatric Chronic Fatigue Syndrome:
http://bit.ly/1QBdBoG (Dundee University)

This is important as this is properly objective scientific research and shows evidence of persistent viral infection in children with ME/CFS and should be taken into account. These children are ill through no fault of their own and they rely on the adults in positions of responsibility for their health care. A mistake has been made with respect to approving the SMILE study – it is not too late to re-evaluate the evidence and correct that mistake.

I look forward to your reply.

With thanks and best wishes,

Jo

Reply from CMO 17th March 2011

Dear Jo

Thank you for your further comments about the “SMILE” study.

I am sorry you misunderstood my explanation of the purpose and expected outcome of research as particular support for this piece of research.  As I mentioned in my email of 11 March, research ethics committees’ decisions are independent of Government, so it would be inappropriate for me to enter into a discussion about a research ethics committee’s review or opinion of a particular research proposal, or about the ethics of a particular research proposal that a research ethics committee has reviewed or given an opinion of.

Best wishes
Sally

Reply to CMO 17th March 2011

Dear Sally,

Many thanks for your prompt response.

I assure you that I do understand your position and I do not expect you to engage in a discussion about ethics committee’s decisions. It was your final sentence that caused concern,

“I look forward to its findings with interest.”

This suggests that you take a favourable view of the study, and I hope you can understand how that sounds, under the circumstances; and given all the facts about the Lightning Process and this particular study of it in children with ME/CFS that have now been made available to you, I wondered whether that was what you intended to say.

Best wishes,

Jo

Reply from Research Governance Manager on behalf of CMO 17th March

Dear Ms Best,

Thank you for your e-mail of 17th March regarding the “SMILE” study, which the Chief Medical Officer has passed to me as the responsible official.

The Department of Health naturally looks forward with interest to the findings of research, because research findings help us know which treatments etc are better than current standard practice, as well as which ones are not. That interest is not meant to suggest our particular favour for an individual research project.

I hope that clears up any ambiguity and deals with your concern.

Yours sincerely,

Bill Davidson
Research Governance Manager
Department of Health
Quarry House
Quarry Hill
Leeds LS2 7UE
Tel: 0113 254 6184 / 07900 164755
Fax: 0113 254 6174

Reply to Research Governance Manager 17th March 2011

Dear Mr. Davidson,

Thank you for taking the trouble to clarify that ambiguity – I do feel
reassured that the CMO is not specifically looking forward to the
results of this particular study.

Just to clarify for you – the Lightning Process is not a treatment and
it is not a therapy – hence this study will not provide any
information about treatments.

I hope we are all clear now.

Thank you again.

Your sincerely,

Jo

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Letter to Dr. Crawley 17.3.2011

Dear Dr. Crawley,

Re: Lightning Process Pilot Study

I am writing to ask you to supply the names and business addresses of the practitioners who will be carrying out the Lightning Process with the children in this study. I am not alone in having assumed it was Alastair Gibson, as he was named as being involved in your study proposal.

Following the recent correction of the mistake in the minutes of the ethics committe review meeting, naming Phil Parker directly as the subject of the ASA ruling last June, instead of Alastair Gibson’s trading of The Phil Parker Lightning Process through Withinspiration, I have been assured by Joan Kirkbride that Alastair Gibson will not be involved in research interventions with the children taking part in this study. However, she was unable to tell me which Lightning Process practitioners will be  carrying out the Lightning Process with the children and asked me to refer to the research team for this
information.

I note that several children had already been recruited for the study by the time of the ethics committee review meeting, at which you were advised to include the risks of taking part in the patient information.  Would you please confirm whether those young people and the parents of children were subsequently informed of the risks.

I would be grateful if you would also let me know whether the interventions have begun.  I am among those who remain very concerned about the ethical aspects of this study.  As the NRES is currently reviewing further concerns arising from the points made at the review meeting, and given that this is taking some considerable time, I would feel reassured to know that the interventions will be delayed until they have had time to respond.

Thank you for providing this information – I look forward to your reply.

Yours sincerely,

(Patient Advocate)

Posted in Bristol University Centre for Child and Adolescent Health | Leave a comment