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Response to Review of Ethics Approval for SMILE study of Lightning Process on Children with ME/CFS 16th January 2011

Posted Jan 18 2011 7:25pm
The following letter was sent with 67 co-signatories. Additional signatures to NRES will be sent every few days until a reply is received, so if you wish to add yours, please send your name, address or home town, and illness status to
fownatsmile@gmail.com


To:

Mrs Joan Kirkbride

Head of Operations

National Research Ethics Service

Darlington PCT

Dr Piper House, King Street, Darlington DL3 6JL

Direct Line – Mobile 07979 806425

Tel: 01325 746167 (Assistant – Janet Kelly)

Fax: 01325 746272

Email: joan.kirkbride@nres.npsa.nhs.uk

Website:http://www.nres.npsa.nhs.uk/



cc Tom Lucas  tom.lucas@uhbristol.nhs.uk



16.01.2011



Dear Mrs. Kirkbride,



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.



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.  Patient surveys

had already shown what the RCTs eventually showed.  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.



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.



1.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?



2.Please specify the conflicts of interest in this study and clarify

where these are declared in the study proposal.



3.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?



4.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.



5.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?



6.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?



7.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.



8.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.



9.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,

Esther Crawley.



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.



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.



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.



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 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


Q1.

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?

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?

4.Is it normal practice for research to be conducted on the basis of

such requests from children and families?

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?



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.



1.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?



Q4

1.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”.

2.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?

3.If the question was about the standard NHS “treatment”, what

evidence did Esther Crawley provide that this is different for adults

and children?

4.Does this mean that she does not follow current NICE guidelines for

“CFS/ME”?

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?

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?

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?

9.Why is there a need to evaluate if LP works, simply because children

are being exposed to it?

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?

11.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.

1.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?

2.With regard to all sessions being recorded, will this be video or

just audio recording and will the whole of each session be recorded?

3.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?

4.Will the parents observe each session?

5.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?

6.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?



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?

2.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?

3.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?

4.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?

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?

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?

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?

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

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 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.



Yours sincerely,



Jo Best
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