Letter To: Mrs Joan Kirkbride, Head of Operations, National Research Ethics Service
Dear Mrs. Kirkbride,
Re: Pilot Study of Lightning Process in Children with ME/CFS (SMILE)
Thank you for your email of 6th January. Please accept permission to re-post this reply and consider the content to be in the public domain, except for the personal details of the co-signatories to this letter. I appreciate the NRES and SW REC review of this study application. It was clear that the SW REC had already had to make several suggestions and improvements to the original study proposal, and I concur with the additional recommendations for the important inclusion of the risks in the PIS. However, I would like you to take account of the following points.
As someone with concerns about the human rights and safety of children in general, and of children with sickness and disability in particular, I am, as you would expect, disappointed by the SW REC’s decision to uphold its approval of this study. I feel sure you will agree that this is a very serious issue, given that it concerns children. However, it is clear from your comments that you do not have a full understanding of the issues pertaining to research and treatment of Myalgic Encephalomyelitis and the condition known as Chronic Fatigue Syndrome.
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.
If anyone with a history of ME/CFS is at risk of relapse simply from giving blood, how much greater risk is involved by exposing them to a training programme that is based on a contentious and unproven scientific hypothesis about the illness. Research published last year showed evidence of persistent viral infection in children with ME/CFS, so Esther Crawley’s excuse that the condition is different in adults and children does not hold water and is unproven.
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?
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. Myalgic Encephalomyelitis is a distinct disease entity 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.
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. These two therapies were shown in the UK FINE trial, published in 2010, to be ineffective in the long term for ME/CFS. You are also aware that both can, in fact, be harmful to a significant number of patients. The reason that these therapies are ineffective and potentially harmful is that they are based on a “biopsychosocial” model of ME/CFS, which is heavily weighted to the “psychosocial” and lip service paid to the “bio”. In other words, this model incorrectly supposes that it is essentially a psychological condition rather than an organic disease. Make no mistake, ME is not only very much an organic disease but is also multi-systemic. There are several biomarkers and physically-measurable signs of this disease, as evidenced by several thousands of research papers, but these are not used to investigate the condition in UK. This is a most unhelpful head-in-the-sand approach to the condition, which proponents of the biopsychosocial model, such as Esther Crawley, seem to be very reluctant to let go of. Evidence of the true pathology of this disease is there if the doctors will only do the right tests to find it: just because they refuse to look does not mean it is not there.
The Lightning Process is based on this biopsychosocial model of ME/CFS. The claim that it is based on physiology is disingenuous, and is clearly being used by the merchant of the product to give it an air of medical or scientific credence. 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 proven, which surely cannot be that difficult, is simply a reckless stab in the dark. It is incredible that the NRES is willing to take such unnecessary risks with children’s health, giving validity to an unlicensed non-medical product in the meantime.
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. This has now been rectified, but only because of this review. It is disconcerting that the NRES does not consider this to be a serious matter and that neither the SW REC, nor the NRES, appear to have any doubts about the validity of any other of Esther Crawley’s statements or responses on the basis of this serious and glaring incorrect answer on the original application. Is it not a basic right of patients to be told of the potential risks of any treatment? It is clear from the APPG Inquiry that she gave evidence to, and referred to at this meeting, that she was aware of the risks, yet she omitted to declare this in her proposal. It is not acceptable to claim the data relates to adults. The joint survey of AfME and AYME does not specify that the LP responses related only to adults and, more importantly, treatment that can harm adults must be treated as potentially harmful to children. It is disturbing that the NRES is comfortable with entrusting the safety of children with neuro-immune disease to this researcher.
Concerns about 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. Unfortunately, the competency and judgement of the SW REC and, by association, the NRES, has also now been shown to be sadly lacking and the procedural arrangements of the NRES clearly need to be subject to rigorous review, as they have failed to serve the public interest in this matter. Please find below a more detailed response to points raised in the minutes of the meeting that you kindly attached, with further questions arising.
Response to the Extract of Minutes from South West 2 REC meeting held on 2 December 2010
If this meeting was intended to “debate” the representations or objections to the study, why did the NRES invite only representatives from the research to this meeting and no representatives opposing the research, so that a proper debate of the issues could have taken place or at least, informed questions asked? 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.
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.
- 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?
- Please specify the conflicts of interest in this study and clarify where these are declared in the study proposal.
- 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?
- 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.
- On what basis did the committee accept the researcher’s view that “CFS/ME” is different in children than in adults? What research evidence did it analyse to come to this conclusion?
- The committee accepts the researcher’s claim that ME/CFS is different in adults to children. 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?
- 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.
- 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 committee was assured that, “Supervision of the process was in place”. By whom? An expert, independent observer? The parents?
- 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?
- 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, Esther Crawley.
- 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.
- 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 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.
- 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 is what LP is really based on – a quick read of the website will show that, and evidence of this was provided to the SW REC.
With reference to the questions the committee put to the researchers:
- 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?
- How many requests did she receive?
- Were the requests from children and families having already undergone LP or wanting advice about whether to try it?
- Is it normal practice for research to be conducted on the basis of such requests from children and families?
- 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?
- 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.
- 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?
- 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”.
- 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?
- If the question was about the standard NHS “treatment”, what evidence did Esther Crawley provide that this is different for adults and children?
- Does this mean that she does not follow current NICE guidelines for “CFS/ME”?
- 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?
- 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?
- What is the relevance of her comment about paediatric services dealing with education rather than work?
- What difference does this make to treatment approaches and outcomes?
- Why is there a need to evaluate if LP works, simply because children are being exposed to it?
- 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?
- What is a specialist NHS doctor doing even being involved with the evaluation of a non-medical training programme in children, when the premise on which it is based is not scientifically proven?
- 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.
- 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?
- With regard to all sessions being recorded, will this be video or just audio recording and will the whole of each session be recorded?
- 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?
- Will the parents observe each session?
- 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?
- 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?
- 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?
- 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?
- 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”. “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 APPG noted that it had received representations about LP, some positive and some negative, stating it was not suitable or effective for all patients but that further investigation of its efficacy might be undertaken (I gather it was subsequently concluded that further investigation should not be undertaken). Considering that Esther Crawley gave oral evidence to the group, it is not noted that she pointed out any difference between outcomes for children compared with adults. Why was this important point not made to the APPG?
- 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?
- 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?
- 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?
- On what basis can this risk be described as “slight”?
- 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 minutes read, “The committee felt that given current treatment uncertainty research was vital in this area and the proposal is a standard way to assess this. Currently survey data were limited and it was unwise to base health policy on individual case reports. It is vital to see if the lightening process is or is not helpful as children are already receiving this therapy”.
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.
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.
Why was Esther Crawley not asked about this new research and whether the findings have any bearing on her views about the potential risks and benefits of this study of LP?
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.
Please note that the co-signatories completely endorse the content of the letter and wish to make known their grave concern about all the matters which have been raised therein.
Thank you for your consideration of these important issues and we look forward to your response.
(Patient Advocate & co-signatories)
NRES replied 6th April 2011 – https://frownatsmile.wordpress.com/2011/04/06/nres-reply-to-response-to-ethics-review-of-smile/
Mrs. Kirkbride had replied on 1st April 2011 –
Thank you for your email. This matter is now subject to a further
formal complaint about the handling of issues raised to date and I am
therefore unable to provide any further replies to correspondence. I
have copied the email to Dr Janet Wisely, NRES Director who is the
investigating officer for the complaint.
I apologise for the long delay in being able to respond to your letter
of 17 January, but as previously advised the length of this
correspondence has needed Dr Davies and I to spend a significant
amount of time to consider carefully the points you raised, including
accessing documentation referred to such as the APPG Inquiry. Dr
Davies and I have today agreed the final draft of the response which
will be sent to you at the beginning of next week.