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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