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
Mrs Joan Kirkbride
Head of Operations
National Research Ethics Service
Dr Piper House, King Street, Darlington DL3 6JL
Direct Line – Mobile 07979 806425
Tel: 01325 746167 (Assistant – Janet Kelly)
Fax: 01325 746272
cc Tom Lucas firstname.lastname@example.org
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
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
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
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
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
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
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
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,
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
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
With reference to the questions the committee put to the researchers
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?
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
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
4.Does this mean that she does not follow current NICE guidelines for
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
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
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?
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
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?
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
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
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
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
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.