BMJ takes two months to publish letter on Lightning Process and SMILE pilot study in children

A not very rapid Response: BMJ takes two months to publish letter on Lightning Process and SMILE pilot study in children

Shortlink: http://wp.me/p5foE-3fj

On 14 July, I submitted a Rapid Response to the BMJ in reply to a response published on 8 March by a Dr Munglani, Consultant in Pain Medicine, West Suffolk Hospital. Dr Munglani had recommended the Lightning Process and given a link to the Lightning Process website in the references at the end of his own Rapid Response to an article about pain management, published in the BMJ in January.

BMJ Rapid Responses usually appear within two or three days following submission and when mine failed to appear on the site, I assumed it had been rejected for publication by the Rapid Response Letters Editor.

In fact, my letter was published by the BMJ but not until 14 September. Why this letter had been held back over two months isn’t known and an enquiry to the Letters Editor has met with no response.

My Rapid Response can be read here on the BMJ site:
http://www.bmj.com/content/340/bmj.b5683.extract/reply#bmj_el_238859

BMJ Original article:

Views & Reviews: From the Frontline: Bad medicine: pain
Des Spence (Published 6 January 2010)
BMJ 340:doi:10.1136/bmj.b5683:
http://www.bmj.com/content/340/bmj.b5683.extract

Rapid Response Re: Failure to appreciate pain is a symptom not a diagnosis is what leads to bad medicine
Suzy Chapman, BMJ (Published 14 September 2010):
http://www.bmj.com/content/340/bmj.b5683.extract/reply#bmj_el_238859

in reply to Rapid Response to article: “From the Frontline: Bad medicine: pain”:

Failure to appreciate pain is a symptom not a diagnosis is what leads to bad medicine, Rajesh Munglani, BMJ (Published 8 March 2010):
http://www.bmj.com/content/340/bmj.b5683.extract/reply#bmj_el_232414

————————–

Between late July and early August, the testimonials by Dr Munglani to which I had referred in my response were taken down from the website of the Rowan Centre. Dr Munglani’s testimonials had read:

I have been very impressed with the results of the LP. I have seen the lives of some of my patients transformed by this self empowering technique. Everyone who has battled with chronic illness and wants to win should have an opportunity to do the Lightning Process. Professor Rajesh Munglani. MB BS DCH DA FRCA FFPMRCA. Consultant in pain medicine. West Suffolk Hospital and Nuffield Health Cambridge Hospital.”

Between late July and early August, the Rowan Centre ceased offering the Lightning Process and all references to the Lightning Process and Lightning Process logos have been removed from their webpage. They now offer their own flavour of the “process”, known as the “BodyMind Programme”.

See their rationale for distancing themselves from the Lightning Process here:
http://www.simpsonandfawdry.com/about-simpson-and-fawdry.htm

Text on the Rowan Centre website was changed from:

“People using the Lightning ProcessTM have recovered from, or experienced significant improvement with the following issues and conditions…”

to:

http://www.simpsonandfawdry.com/lightning-process.html#lp1

“We have helped people with the following illnesses and conditions…”

Text on their “Introduction” page reads:

http://www.simpsonandfawdry.com/lightning-process.html

“There are now NHS and private consultants, GPs and occupational therapists referring their patients to us at the Rowan Centre. Clinicians in the NHS have observed the work we do. To find out more, you can speak to Gael Postle, Occupational Therapist at the James Paget University Hospital pain clinic on 01493 453307 or the O.T.s at the Norfolk and Suffolk ME/CFS service on 01502 527579.”

The Rowan Centre also offer their programme for MS patients.

Another Lightning Process site which has changed its text since late July is this one:

http://www.x-eed.com/page/services

which has changed:

“What does it work for?

People using the Lightning Process® have also recovered from, or experienced significant improvement with the following conditions:-

Fibromyalgia
Chronic Fatigue Syndrome
Post Viral Fatigue
Asthma
Rheumatoid Arthritis
Hayfever
Depression
Dyspraxia
Bipolar Disorder
Ocd
Anxiety And Panic Attacks
Insomnia
Cerebral Palsy
Low Self Esteem
Parkinsons Tremors
Motor Neurone Disease
Hyper And Hypo Thyroidism
Chronic Aches And Pains
Ibs
Lyme Disease
Anger Issues
Food Intolerances
Coeliac Disease
Ptsd
Candida
Allergies
Type 2 Diabetes
Interstitial Cystitis
Migraines
Noise And Light Sensitivity
And Many More

Using the Lightning Process® has proven effective for clearing ALL the debilitating physical and mind based symptoms of ME, chronic fatigue syndrome, and post viral syndrome.

Some of the symptoms that people have cleared are listed here…”

[long list of conditions]

to “What do we work with?”

[shorter list of conditions]

 

Here’s a site that hasn’t changed its text:

A Manchester and Cumbria practitioner

http://www.helenjames.com/

“The Phil Parker Lightning ProcessTM is a hugely successful training programme which has transformed the lives of thousands of people whose problems had previously seemed impossible to resolve such as Myalgic Encephalomyelitis (ME), Chronic Fatigue Syndrome (CFS), Post-Viral Fatigue Syndrome (PVFS), Fibromyalgia, Multiple Sclerosis (MS), Obsessive Compulsive Disorder (OCD), Anxiety, Depression and many other debilitating issues.

Helen James is a fully qualified Lightning Process Advanced Practitioner, with many years experience in helping people to recover from numerous conditions. For more information about Helen see the About Helen page.

Many people that have already used the Lightning Process to recover from the above conditions had previously tried all sorts of alternative healthcare treatments and complementary therapies, but the only treatment that is consistently helping 1500 suffers a year to recover is the Lightning Process. 85% of people that have the attended a Lightning Process training make a full recovery, and the recovery is permanent.

http://www.helenjames.com/lightningProcess/more

Further applications for the Lightning Process

The Lightning Process can help you to recover from/resolve any of the following…

.Myalgic Encephalomyelitis (ME)
.Chronic Fatigue Syndrome (CFS)
.Post-Viral Fatigue Syndrome (PVFS)
.Fibromyalgia
.Depression
.Obsessive Compulsive Disorder (OCD)
.Overwhelmedness
.Feeling stuck
.Guilt
.Asthma
.Allergies including Hay Fever
.Bipolar Disorder
.Irritable Bowel Syndrome (IBS)
.Food intolerances
.Hyper and Hypo Thyroidism
.Migraines
.Multiple Sclerosis
.Post Traumatic Stress Disorder (PTSD)
.Anger Issues
.Rheumatoid Arthritis
.Anxiety and Panic Attacks
.Perfectionism
.Procrastination
.Coeliac Disease
.Dyspraxia
.Focal Dystonia (undesirable muscular contraction or twisting)
.Insomnia
.Low self esteem
.Lyme Disease also known as Borrelia or Borreliosis.
.Noise and Light Sensitivity
.Torticollis
.Chronic Aches and Pains

And it’s also effective for enhancing:

.Business success
.Peak Sports Performance

http://www.helenjames.com/lightningProcess/multipleSclerosis

Multiple Sclerosis (MS)
Over the last few years we have started to see number of people getting impressive results when using the Lightning Process with other neurological conditions such as CFS, Parkinsonian type tremors, cerebral palsy and strokes. As a consequence we were asked whether the Lightning Process could be used for improvement and recovery with any other types of neurological illness, particularly Multiple Sclerosis…”

 

Landmark agreement extends ASA’s digital remit

In March 2011, the Advertising Standards Authority (ASA) broadens its remit to include website content:

Landmark agreement extends ASA’s digital remit, News release, 1 September 2010

Related material:

1] SMILE – Specialist Medical Intervention and Lightning Evaluation documents (Lightning Process pilot study – children [now aged 12 to 18] with CFS and ME): http://wp.me/p5foE-37x

2] Background to this issue: http://wp.me/p5foE-2Vt

3] All posts on Lightning Process pilot study in children issue:
https://meagenda.wordpress.com/category/lightning-process-smile-study/

4] Minutes, meeting of the SMILE Pilot External Advisory Group: 2 November 2010: http://wp.me/p5foE-3er

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Church Times: Dr Esther Crawley responds to Prof Robin Gill (SMILE Lightning Process pilot study)

Dr Esther Crawley responds to Prof Robin Gill’s letter of concern (Church Times, 8 October 2010) about the ethics of the Bath/Bristol SMILE Lightning Process pilot study

Shortlink: http://wp.me/p5foE-3eB

On 8 October, Professor Robin Gill had a letter published in the Church Times. A full copy of Prof Gill’s concerns about this pilot study can be read in this posting:

Children should not be used as guinea pigs: Prof Robin Gill, Church Times (Lightning Process Pilot study)

Children should not be used as guinea pigs
Church Times, 8 October 2010

BY: ROBIN GILL

Clinical trials of a training programme for ME, MS, and other conditions raise serious ethical questions, argues Robin Gill.

Canon, Prof Robin Gill is a member of the BMA Medical Ethics Committee, has been a member of the Medical Research Council’s Stem Cell Steering Committee, is President of the Society for the Study of Christian Ethics and Chairs the British Sociological Association’s Study Group of Religion.

In the current issue of Church Times (Page 19, 26 November 2010) the Editor has published this response from Dr Esther Crawley, SMILE pilot study Chief Investigator to Prof Gill’s letter:

Professor Gill’s article on the SMILE study

From Dr Esther Crawley

Sir, — On 8 October, you published an article about a feasibility randomised controlled trial investigating interventions for CFS/ME in teenagers — the SMILE study. This article appeared two weeks after all study documentation was made publicly available, and we are disappointed that the author, Professor Robin Gill, made no attempt to contact the study team to verify his assertions before publication, particularly given the nature and strength of the assertions made.

We agree with Professor Gill that there is limited evidence on the effectiveness of the Lightning Process in treating CFS/ME. Despite this, approximately 250 children a year pay for and attend Lightning Process interventions. It is precisely for this reason that we listened to children and their families who have asked for improved evidence, and are conducting research that will enable them to make informed decisions about their care.

The SMILE project is not “comparing the effectiveness of the Lightning Process with that of conventional medical care”. Participants in this study will receive either specialist medical care or specialist medical care plus the Lightning Process. The purpose of the study is to assess the feasibility of recruitment to a full trial — it is not designed to compare outcomes of care.

In this article, Professor Gill argues that children or non-competent adults should be involved only when competent and consenting adults have been fully tested first or where this is impossible, and he quotes from the guidance issued by the Medical Research Council (MRC) and the General Medical Council (GMC). There are, however, other quotations he could have selected, such as the MRC’s lengthy advice about when research into medical care for children is important (pages 7-8) and ethical (page 13), and similar statements from the GMC.

Our protocol makes it clear that CFS/ME in children is not sufficiently close to CFS/ME in adults to mean that research in adults could be extrapolated to children. The Royal College of Paediatrics and Child Health states: “Research involving children is important for the benefit of all children and should be supported, encouraged and conducted in an ethical manner.”

Professor Gill ends by stating: “The coercion of children is not an ethically acceptable option.” We absolutely agree with this, and deeply resent the implication that our study involves such coercion. This view was encouraged by the cartoon used to illustrate the article, which we find abhorrent and unacceptable.

All the children and families participating in the SMILE study provide fully informed consent/assent by means of a rigorous, recorded procedure that has been reviewed and given a favourable opinion by a research ethics committee. No child is coerced to join the study, and participants can withdraw at any time.

ESTHER CRAWLEY
on behalf of the SMILE Study Group
School of Social and Community Medicine
University of Bristol
Hampton House
Cotham Hill
Bristol BS6 6JS

The Editor apologises for any offence caused by the cartoon, and for any misrepresentation of the research it might have suggested.

Related material:

1] SMILE – Specialist Medical Intervention and Lightning Evaluation documents (Lightning Process pilot study – children [now aged 12 to 18] with CFS and ME):http://wp.me/p5foE-37x

2] Background to this issue:http://wp.me/p5foE-2Vt

3] All posts on Lightning Process pilot study in children issue:
https://meagenda.wordpress.com/category/lightning-process-smile-study/

4] Children should not be used as guinea pigs, Church Times, 8 October 2010: http://wp.me/p5foE-3ak

Transcript: BBC Radio Berkshire, Anne Diamond, ME/CFS: Shepherd, Findley, Parker

Transcript of BBC Radio Berkshire Anne Diamond Show, broadcast 11 November 2010

Shortlink: http://wp.me/p5foE-3dG

On 11 November, Radio Berkshire presenter, Anne Diamond, interviewed Dr Charles Shepherd, Medical Adviser for the ME Association and Professor Leslie Findley, Clinical Director of the National ME Centre and Centre for Fatigue Syndromes. Towards the end of the item, Duncan McLarty spoke to Phil Parker, founder of the Lightning Process.

See also previous post: http://wp.me/p5foE-3dk

Within the UK, until 18 November, you can “Listen again” to the Radio Berkshire broadcast here on BBC iPlayer. The item starts 2 hours 3 mins in from the start of programme and is around 12 minutes long.

Or listen on YouTube here: http://www.youtube.com/watch?v=9YX3wFkDlhI

This transcript has been prepared by Suzy Chapman for ME agenda. Care has been taken in the preparation and proofreading of this transcript; some errors and omissions may remain.

The Anne Diamond Show, Thursday, 11 November 2010:

Anne Diamond: Last week on the show while Esther Rantzen was standing in, we looked at the subject of ME because people diagnosed with the condition are no longer able to give blood. Now we’ve had a huge response from people with experience of the condition and because this is such a controversial area we thought it might be a good idea to get some experts on to the show to deal with some of the points that have been raised.

Dr Charles Shepherd is Medical Adviser to the ME Association and Professor Leslie Findley is Clinical Director of the National ME Centre and the Centre for Fatigue Syndromes. I spoke to them both, earlier, and I asked Charles Shepherd just what is ME and are we any closer to knowing what causes it?

Dr Charles Shepherd: Well ME stands for “Myalgic Encephalomyelitis” and in very simple terms it’s an illness which often starts with a viral infection and people then have a range of symptoms, primarily muscle symptoms, muscle fatigue and also brain symptoms, problems with memory, concentration, balance, just generally feeling unwell. And these systems – I mean these symptoms – persist for a long period of time in many of these patients; it is a very disabling and has been recognised as a neurological illness.

Anne Diamond: Yes. Professor Findley, to be absolutely clear, nowadays there’s no longer any suggestion that it’s a psychological condition, is there?

Prof Findley: Erm, no, there’s no suggestion it’s a psychological condition but psychological factors can adversely influence the symptoms and they have to be taken into account when one’s planning a total management strategy for an individual patient.

Anne Diamond: Would you agree with that, Dr Shepherd, that nowadays we don’t look upon it as a psychological condition?

Dr Charles Shepherd: Well, I thoroughly agree, you know, the Department of Health, the World Health Organisation, classifies this as a neurological illness and you know, like with many chronic disabling illnesses, psychological factors, social factors, can sometimes play a role, that’s not disputed. But it is essentially a neurological illness with other factors involved.

Anne Diamond: Now you see, since Esther was talking about this last week we’ve had an email, for instance, which says that all the research and treatment funding then has inappropriately gone to the psychiatric profession since the 1980s. What do you say to that, both of you?

Dr Charles Shepherd: Well, to a certain extent well that is true. Certainly in the UK, the vast amount of government funded research has gone in to behavioural and psychological therapies and there has been a great deal of criticism about that. Fortunately, what we now have is the Medical Research Council [MRC] setting up an expert group which I am a member of, to look into research in this illness and we have been for the past two years looking at what needs to be done in the way of biomedical research and a list of priorities in biomedical research has now been sent to the board of the MRC – they are looking at these priorities and we are expecting an announcement very shortly on this.

Anne Diamond: Professor Findley, is it true then that we’ve been wasting money – directing the money towards the psychiatric profession?

Professor Findley: We….ell! Waste is a very, is a very strong word to use. The money, I agree with Charles, could have been used perhaps more wisely, but this is a complex illness and it represents, and the MRC would state this, that it represents a group of disorders, it is not a single entity and we’re still having great trouble defining within this large group of patients the individual types of Chronic Fatigue Syndrome/ME that exist and if one takes a group of patients the symptom complex that the individuals complain of vary enormously…

Anne Diamond: And yet…?

Professor Findley: …and the NICE Guidelines recognise complex and severe Chronic Fatigue Syndrome/ME to emphasise the complexity of this, this, this illness, it is not a simple entity it’s not like some tuberculosis where you have a defined marker and a defined organism and a defined treatment.

Anne Diamond: So and Dr Shepherd, you would agree that this a range of different conditions?

Dr Charles Shepherd: Yes, and I mean this is another key point, that we have renamed and redefined this illness from ME into what’s now called “Chronic Fatigue Syndrome”, the term that the medical profession tends to use and unfortunately this has now produced, it’s rather like dumping everyone with different types of arthritis, inflammatory arthritis, osteoarthritis, infective arthritis, under one umbrella and saying that they’ve all got the same cause, the same symptoms and the same treatments and that does not apply to arthritis, it does not apply to everyone who comes under this umbrella of Chronic Fatigue/Chronic Fatigue Syndrome.

This is one of the key points the MRC is addressing the need for sub grouping people under this umbrella, finding the different causative factors that are going on and then applying appropriate different forms of management to the different types of sub groups under this umbrella.

Anne Diamond: Now, I mean, you look at the situation – for instance here in Berkshire – where our Primary Care Trusts [PCTs] are offering Cognitive Behavioural Therapy [CBT]. Is that appropriate any longer?

Dr Charles Shepherd: It’s not appropriate as a one size fits all treatment and this is our big problem with the NICE Guideline, it’s why patients object to the NICE Guideline because the NICE Guideline recommends CBT and Graded Exercise Therapy [GET] should be offered to everyone with mild to moderate ME and this is not what we feel is appropriate one size fits all treatment. Many patients find these therapies either ineffective, around about 50% with CBT and in the case of Graded Exercise treatment, if you apply this wrongly you make these patients worse. That’s why there is terrific concern and anger amongst the patient community with the NICE Guideline.

Anne Diamond: Can I move on to the…this business of the Lightning Therapy, the Lightning Process? Because it was very controversial when Esther was talking about it last week. Her daughter went through it, but some listeners were angry that we even mentioned the Lightning Process. Why is it so controversial? Professor Findley, first…

Professor Findley: Erm, that’s a very straightforward question with a very complex answer. I think the Lightning Process has a part to play in the management of some patients. It is not a specific treatment for Chronic Fatigue Syndrome/ME, it’s used to treat a whole raft of conditions. But there are some patients that can be recognised who have factors which would lend themselves – factors which are perpetuating the illness – which would lend themselves to the Lightning Process.

Now these are, in my opinion, a very small group of patients overall, but because Lightning Process practitioners are often only experienced in that one technique they apply it to anybody who visits them with an objective of getting treatment, so their patients are treated in an unselected manner and therefore this has led to all sorts of complications and dissatisfaction.

Anne Diamond: Dr Shepherd?

Dr Charles Shepherd: Well, I have this strong objection to the Lightning Process – in particular the way it’s marketed to very vulnerable groups of people with adverts which are making unsubstantiated claims about success rates.

Professor Findley: Agreed…agreed.

Anne Diamond: But it clearly is true for some and as you both seem to be agreeing that this is multi-factorial, very complex, no one patient is exactly the same as the other.

Professor Findley: Well I think I absolutely agree with this, but erm… the…and I agree with Charles’ comments on the Lightning Process – it’s been badly, badly applied, poorly researched and we would use it or recommend it probably in perhaps one in thirty or one in forty of patients, after they have been properly assessed over a long period of time and more standard management programmes have been applied.

Anne Diamond: Before we run out of time, can I finally ask both of you really ‘cos a lot of people who contacted us were asking about recovery rates from ME. What can you tell us about the numbers and are indeed there any robust figures on this? Dr Shepherd, first.

Dr Charles Shepherd: Well, I wouldn’t say there were really robust figures. I think its, a lot of it is clinical judgement from individuals, you know, that see patients with this and you know, a limited amount of epidemiological research.

Where I come in is I think we probably have three groups. We have a group at one end of the spectrum who are severely effected certainly at some stage in their illness and they probably account for about 25% of the total, I mean these are people who are bed-bound, wheelchair-bound, house-bound.

We have a large group in the middle who make some degree of, I think the word here is improvement, over the course of time but do not recover but they hit a glass ceiling, 50, 60, 70% of what they were normally like and then we have a small group at the other end of the spectrum who make a much more significant degree of improvement or may even finally recover – an example there is Yvette Cooper, a former government minister. I would add that the improvement/prognosis in children/adolescents with this disease does seem to be a lot better than it is in adults.

Anne Diamond: And Professor Findley?

Professor Findley: I would, there aren’t robust figures and I think Charles is right, we would normally say that the average duration taken across the group, the average duration of this type of illness is three to five years with at least 40% of patients never getting back to previous levels of functioning and I’d agree with Charles there is the very severe group and their prognosis is appalling and they very rarely get any proper management advice.

Anne Diamond: Well that was Dr Charles Shepherd and Professor Leslie Findley speaking to me a little earlier on. It’s a very important subject isn’t it?

It’s very important that we hear a balanced argument on it. So we put some of those issues to the founder of the Lightning Process, Phil Parker. Phil’s website calls the process “A non medical tool that is tailored to help people who are stuck in their life or health”. Well BBC Radio Berkshire’s Duncan McLarty, first asked him whether he agreed that the process is only appropriate in a small fraction of ME cases.

Phil Parker: You know that sounds like scientific data but it’s not science – there’s no evidence to say that, that’s just their opinion! First thing we do is have a chat with people and we assess them as to whether this is a really useful thing for them because obviously we want to see people who we think are going to get value from this.

Duncan McLarty: But if you’re not an ME specialist how would you know if it’s appropriate?

Phil Parker: Er, well we are specialists at the Lightning Process. We know more about the Lightning Process than these people because we designed it and trained in it. So what we are looking for is, do we think these people are likely to get benefit from the stuff that we do. What we’re really interested in is how can we help these people who, who’ve got stuck, where there aren’t many solutions, is there anything we can do to help them that’s really where we’re coming from.

Anne Diamond: Well can I just say thank you very much for all your emails on the subject of ME over the last week or so. I think we’ve certainly shown that it’s a complex area with plenty of strong and sometimes conflicting views. We also asked Phil Parker whether he agreed that the process was aggressively marketed as those two experts told me.

Phil Parker: Basically our practitioners, erm, don’t make claims. What they say is, that you know our experience is, that when some people use this they can make changes. That doesn’t guarantee change. If you…you know you have a business then you want to tell people about it that doesn’t make it aggressive marketing, that’s the thing I… deny and say that all we’re doing is, say look this is something that we’ve found is very useful, have a look at it and if you want to talk to us more about it then do, if you don’t that’s fine as well. We really don’t market it aggressively at all.

Anne Diamond: Well there you are, you see, that was Phil Parker, who is the founder of the Lightning Process, and earlier on I was talking to Dr Charles Shepherd, Medical Adviser to the ME Association, and Professor Leslie Findley who’s Clinical Director of the National ME Centre and the Centre for Fatigue Syndromes.

Related material:

1] SMILE – Specialist Medical Intervention and Lightning Evaluation documents (Lightning Process pilot study – children [now aged 12 to 18] with CFS and ME): http://wp.me/p5foE-37x

2] ASA adjudication against “Withinspiration”, June 2010

3] Background to this issue: http://wp.me/p5foE-2Vt

4] All posts on Lightning Process pilot study in children issue on ME agenda: https://meagenda.wordpress.com/category/lightning-process-smile-study/

ME in Parliament: Written Questions: ME and UK blood ban; Retrovirals and ME research

ME in Parliament: Written Questions: ME and UK blood donor ban; Screening stored blood; Retrovirals and myalgic encephalomyelitis (ME) research

Shortlink: http://wp.me/p5foE-3bx

From the News pages of the ME Association

Parliamentary Questions: the UK blood ban on people with ME/CFS

by Tony Britton  |  19 October 2010

Caroline Lucas, leader of Green Party and MP for Brighton Pavilion, tabled two written questions on the blood ban which is to be imposed on everyone in the UK who has ME/CFS from November 1.

In the first, she asked the Secretary of State for Health on what date his Department’s decision that people with myalgic encephalomyelitis should not give blood was (a) made and (b) implemented.

In her written reply on 19 October 2010, Anne Milton (Parliamentary Under Secretary of State for Public Health) wrote:

The UK Blood Services decision to permanently exclude from blood donation anyone who reports that they have had Myalgic Encephalopathy/Chronic Fatigue Syndrome (ME/CFS) was made on 8 July 2010. The change to the donor selection guidelines will come into force on 1 November 2010.

This change is being made on the grounds of donor safety, as ME/CFS is a relapsing condition. It brings practice for ME/CFS into line with other relapsing conditions or neurological conditions of unknown origin.

The change is being made on the grounds of donor selection criteria by the UK Blood Services Standing Advisory Committee on the Care and Selection of Donors, and Joint Professional Advisory Committee.

In her second question, Caroline Lucas asked the Health Secretary whether – with reference to an answer given to the MP for Stroud on 27 January* whether (a) the UK Blood Services and Health Protection Agency study of the prevalence of a rodent virus linked to ME and (B) his Department’s risk assessment in respect of the study had been completed; and if he will make a statement.

Anne Milton replied:

There has been a consistent failure of independent European and American studies to confirm the original American study that described the detection of xenotropic murine leukemia virus-related virus (XMRV), a virus related to rodent viruses, in patients with chronic fatigue syndrome, sometimes referred to as myalgic encephomyelitis.

An expert subgroup of National Expert Panel for New and Emerging Infections (NEPNEI) met in May 2010, to consider all available evidence about XMRV and conduct a risk assessment. The subgroup concluded that XMRV can infect humans but there is currently no evidence that it causes human disease and that on the evidence before the group, no public health action is required at this time. Since the subgroup meeting in May there has been no new scientific evidence that would change the conclusions of the subgroup but they are keeping it under review.

The Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO), on the basis of current evidence does not recommend further measures at present but wishes to continue to monitor the situation. The NHS Blood and Transplant and Health Protection Agency study group concur with the views expressed both by NEPNEI and SaBTO but also recognise the need for further research on the prevalence of XMRV in the United Kingdom.

In a recent unpublished pilot study conducted by the group a series of 540 randomly selected English blood donors were screened for XMRV and none were found to be infected.

ME Association questions the rationale behind the blood ban – BBC News Report (8 October)

MEA medical adviser, Dr Charles Shepherd, discusses the subject on the BBC R4 ‘Today’ programme

* The 27 January Parliamentary Question

 

From the News pages of the ME Association

Parliamentary Questions: UK blood banks and XMRV

by Tony Britton  |  21 October 2010

The Minister for Public Health, Anne Milton, has responded to related questions from two MPs about what the Department of Health plans to do with blood from people with ME that is held in storage or whether he has any plans to screen blood already held in storage for the XMRV virus.

David Anderson (Labour MP for Blaydon) asked if the Department of Health would be screening blood held in blood banks for the XMRV virus. And Sharon Hodgson (Labour, Washington and Sunderland West) asked whether the Department would be removing from storage blood donated by people with ME.

In her written answer on 20 October 2010, the Minister replied:

There are no plans to screen blood already stored in blood banks for the xenotropic murine leukemia virus-related virus (XMRV) or to remove from storage blood donated by persons diagnosed with myalgic encephalomyelitis.

A recent study in the United States (of America) reported that XMRV has been detected in a number of chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME) sufferers. CFS/ME sufferers can currently give blood when they are well. These data have not been replicated in Europe.

An expert subgroup of National Expert Panel for New and Emerging Infections (NEPNEI) met in May 2010, to consider all available evidence about XMRV and conduct a risk assessment. The subgroup concluded that XMRV can infect humans but there is currently no evidence that it causes human disease and that on the evidence before the group, no public health action is required at this time. Since the subgroup meeting in May there has been no new scientific evidence that would change the conclusions of the subgroup. In July 2010, the Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO), similarly did not recommend further measures at present. Both groups will continue to monitor the situation.

However, from 1 November 2010, CFS/ME sufferers will no longer be able to donate blood. The UK Blood Services recognised that exclusion from donation by people with ME/CFS needed to be brought in line with that from other relapsing conditions for the protection of the donor, and not because of potential infection risks.

Parliamentary Written answers and statements, 21 October 2010

David Anderson (Blaydon, Labour)
David Willetts (Minister of State (Universities and Science), Business, Innovation and Skills; Havant, Conservative)

Hansard source (Citation: HC Deb, 21 October 2010, c867W)

Chronic Fatigue Syndrome

Mr Anderson: To ask the Secretary of State for Business, Innovation and Skills if he will provide funding for research on the relationship between retrovirals and myalgic encephalomyelitis. [18037]

Mr Willetts: The Medical Research Council (MRC) is one of the main agencies through which the Government support medical and clinical research. In keeping with the Haldane Principle, prioritisation of an individual Research Council’s spending within its allocation is not a decision for Ministers. Such decisions are rightly left to those best placed to evaluate the scientific efficacy of proposed research.

The MRC is committed to supporting scientific research into all aspects of ME, including studies into the biological basis of the condition and evaluations of treatments. In 2009/10 the MRC spent £109,000 on research directly relating to ME.

also recorded at:

http://www.theyworkforyou.com/wrans/?id=2010-10-21a.18037.h&s=chronic+fatigue+syndrome

Children should not be used as guinea pigs: Prof Robin Gill, Church Times (LP pilot study)

Children should not be used as guinea pigs: Prof Robin Gill, Church Times (Lightning Process Pilot study)

Shortlink: http://wp.me/p5foE-3ak

Canon, Prof Robin Gill is a member of the BMA Medical Ethics Committee, has been a member of the Medical Research Council’s Stem Cell Steering Committee, is President of the Society for the Study of Christian Ethics and Chairs the British Sociological Association’s Study Group of Religion.

[In his letter to Church Times, Prof Gill refers to the ASA ruling handed down to a Bournemouth company, in June. This was Lightning Process practitioner, Alastair Gibson (“Withinspiration”). Mr Gibson is a member of the pilot study research team led by Dr Esther Crawley. Fiona Finch (Director, Phil Parker Group) and Phil Parker are also collaborators in the pilot study and all three are listed in the application for research ethics approval and Study Protocol document.]

From the ME Association News Page

and now also available on the Church Times site

Children should not be used as guinea pigs

Church Times, 8 October 2010

BY: ROBIN GILL

Clinical trials of a training programme for ME, MS, and other conditions raise serious ethical questions, argues Robin Gill.

An impassioned online debate has arisen about the authorisation this summer of a scientifically controlled clinical trial of children by a consultant paediatrician linked to Bristol University. The trial plans to recruit children aged 12 to 18 with ME, or chronic fatigue syndrome (CFS), into a randomised controlled trial, comparing the effectiveness of the so-called Lightning Process with that of conventional medical care.

Critics argue that the Lightning Process is being promoted commercially for use across a wide range of medical conditions, even though it is as yet scientifically untested for its effectiveness or even safety, and that it should be tested on volunteer, competent adults long before it is tested on children. It is not, of course, for a theologian to pass any scientific judgement on the Lightning Process. At an ethical and theological level, however, it does raise issues that have arisen before in the context of commercially driven faith-healers. Morris Cerullo’s Mission to London in 1992 raised these issues in a sharp way, for example.

The Lightning Process was developed by the Phil Parker organisation, and involves a three-day course, said to be based upon neuro-linguistic programming (which is concerned with brain-body connections) and life coaching. This programming, or coaching, seeks to make your mind influence your condition in such a way as leads to improvements in the condition. The organisation’s website emphasises that the Lightning Process is thus neither a therapy nor a treatment, but a “training programme” (although clients on the site write about “becoming well”).

The website also claims that this programme can address a very wide range of conditions: ME/CFS, food/ chemical intolerances, depression, fibromyalgia/chronic pain, weight loss, phobias/anxiety/stress, multiple sclerosis, eating disorders, low self-esteem, irritable bowel syndrome/ digestive issues, obsessive-compulsive disorder, and “other conditions”.

The site runs a disclaimer: “Due to the nature of the training we cannot guarantee results as everyone is different, however we have received a considerable amount of positive feedback from clients with chronic illness.” Esther Rantzen, for instance, and her daughter (who has had ME) are both quoted giving such positive feedback.

Mr Cerullo also claimed to be able to address a wide variety of conditions. The advertising campaign for his Mission to London featured posters showing discarded white canes and overturned wheelchairs, and carried the caption (without any disclaimer): “Some will see Miracles for the First Time”.

After investigating complaints, the Advertising Standards Authority (ASA) concluded in October 1992 that the posters had been “targeted on the disabled”, and were “a source of distress”. Similarly, in June 2010, the ASA found against an advert carried by a Bournemouth company that they “did not hold robust evidence to support their claims that the lightning process was an effective treatment for CFS or ME . . . we concluded that the claims had not been proven and were therefore misleading.” Arguably, a number of the conditions listed on the Lightning Process website are psychosomatic, and might effectively be addressed by a cognitive training programme. It will be seen, though, that multiple sclerosis is included.

The MS Society remains cautious about this. It replies to enquirers that the claims of the Lightning Process in relation to MS are not currently backed up by scientific trial evidence, and that it is therefore unable to comment on its effectiveness and/or safety.

The MS Society has good reason to be cautious. In the past few days, a doctor has been struck off for exploiting MS patients, after claiming that he could cure them with injections of cow stem-cells. The chairman of the GMC disciplinary panel told him: “You have exploited vulnerable patients. . . Your conduct has unquestionably done lasting harm.”

Critics of the Lightning Process also argue that people (especially the young) who place hopes in the ability of the Lightning Process to improve their condition, and yet find no such improvement, can become more despondent, and feel worse than they were before. They may even stop taking vital medication.

Critics of Mr Cerullo claimed that that is exactly what happened, when a vulnerable person gave up life-sustaining medication and died soon after attending one of his healing services.

The word “currently” is important in the position of the MS Society. It implies that, if the claims of the Lightning Process were based on solid evidence, instead of anecdotes, then its advice could change. This is exactly why cognitive behavioural therapy, for example, has gradually become an accepted medical procedure.

As it happens, there is also a considerable body of reliable survey evidence (some of it resulting from large population studies) that religious beliefs and practices can be a significant factor in health and longevity (as can a happy marriage).

This is certainly not to say that the specific actions of Mr Cerullo would indeed have allowed people to “See Miracles for the First Time.” Nor is it to say that doctors should prescribe churchgoing or marriage to their ill patients (faith and marriage being emphatically both personal commitments, not forms of medication). But it is to say that strong personal commitments do seem to be a part of living healthily. Perhaps that is what the Lightning Process is trying to promote as well.

There is still a problem, however. Critics of the involvement of children in the Bristol ME/CFS clinical trial are surely correct. The GMC and BMA have both insisted for some time that clinical trials should always involve competent adults wherever possible. These adults should be fully informed, and must give their explicit and uncoerced consent. If they then decide to take part in a clinical trial, that is entirely up to them.

Children and incapacitated adults should be involved only when this is not possible (such as when the particular conditions apply only to them) — and, even then, a proper assessment must be made that the clinical trial is genuinely in their best interests. The coercion of children is not an ethically acceptable option.

Canon Robin Gill is Professor of Applied Theology at the University of Kent.

e-mail adress for any letters in reply to this article: letters@churchtimes.co.uk

Copyright: The Church Times 2010

———

Bio for Canon, Prof Robin Gill here: http://www.st-edmunds.cam.ac.uk/faraday/Biography.php?ID=156

Robin Gill is Michael Ramsey Professor of Modern Theology, University of Kent at Canterbury. This unique chair was established in honour of a former Archbishop of Canterbury and Robin is the first holder. Previously he was also the first holder of the William Leech Professorial Fellow in Applied Theology, University of Newcastle upon Tyne. He has particular research interests in health care and Christian ethics and in the sociological study of churches. He is Director of the MA in Applied Theology and teaches Sociology of Religion and Modern Theology at undergraduate level.

Robin Gill was appointed honorary canon of Canterbury Cathedral in 1992. He was theological consultant to the 1998 Lambeth Conference and has been a member of advisory groups on both Theology and Medical Ethics for the Archbishop of Canterbury.

He is a member of the BMA Medical Ethics Committee and has been a member of the Medical Research Council’s Stem Cell Steering Committee, President of the Society for the Study of Christian Ethics and Chair of British Sociological Association’s Study Group of Religion.

Related material:

1] SMILE – Specialist Medical Intervention and Lightning Evaluation documents (Lightning Process pilot study – children [now aged 12 to 18] with CFS and ME): http://wp.me/p5foE-37x

2] ASA adjudication against “Withinspiration”, June 2010

3] Background to this issue: http://wp.me/p5foE-2Vt

4] All posts on Lightning Process pilot study in children issue on ME agenda:
https://meagenda.wordpress.com/category/lightning-process-smile-study/

New evidence that ME, CFS in children could be caused by a virus

A University of Dundee study on children has found further evidence that ME, or Chronic Fatigue Syndrome, could be caused by a virus. 

Shortlink: http://wp.me/p5foE-36c 

Additional reporting will be added to the top 

Media Coverage

Scottish Daily Record  |  Lachlan Mackinnon  | 8 September 2010

Chronic fatigue syndrome may be caused by virus, Scottish researchers find

———————— 

Radio Scotland  |  Jane Colby  |  7 September 2010

Pick up around 11.00 in from start
http://www.bbc.co.uk/iplayer/episode/b00tmfzs/Scotland_Live_07_09_2010/

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WebMD Health News  |  Peter Russell  |  7 September 2010

Health news

Study links ME to virus
A small-scale investigation has found evidence that the debilitating illness could be caused by a virus

Reviewed by Dr Keith David Barnard

———————— 

BBC News 7th September 2010: “Study shows ME/CFS ‘virus link’ found in children”
http://www.bbc.co.uk/news/uk-scotland-tayside-central-11204884  [Extracts already posted below]

BBC Health TV Report 7th September 2010: ME ‘could be caused by a virus’
http://www.bbc.co.uk/news/health-11209605

BBC Radio 4 7th September 2010: Item on Today Programme
http://news.bbc.co.uk/today/hi/default.stm

UKwired 7th Septemebr 2010: Study shows ME/CFS ‘virus link’ found in children
http://www.ukwirednews.com/news.php/87946-Study-shows-ME-CFS-virus-link-found-in-children

———————— 

ME Research UK

http://www.meresearch.org.uk/research/projects/children.html

Abstract and commentary also available on MERUK site

Comment by ME Research UK [note this commentary is heavy with links, please refer to site for links]

Illness in youngsters has a particular poignancy; the transformation of a bright, active child into one who is unable to go to school or play with friends is something that touches us all.

Estimates of the numbers of children affected by ME/CFS vary, but with prevalence figures of 60 to 70 cases per 100,000, it is likely that around 9,000 people under the age of 16 in the UK have this diagnosis. As the report to the Chief Medical Officer in 2002 made clear, this illness “represents a substantial problem in the young” and “potentially threatens physical, emotional, and intellectual development of children and young people, and can disrupt education and social and family life, at a particularly vulnerable time of life”.

The results of a previous study on quality of life in children with ME/CFS were recently published in Pediatrics by Dr Gwen Kennedy at the Vascular and Inflammatory Diseases Research Unit in the University of Dundee. In parallel with this work, Dr Kennedy and her colleague Dr Faisel Khan have been investigating biochemical and vascular abnormalities in children with the disease, and their results have just appeared in the US journal Archives of Pediatrics and Adolescent Medicine.

The Dundee group had previously reported a number of biochemical and vascular abnormalities in adults with ME/CFS. These mainly involve the immune and cardiovascular systems, and include an increase in the programmed death (apoptosis) of white blood cells, raised levels of oxidative stress which can damage blood vessels and other organs, increased markers of inflammation, and abnormalities in blood vessel function. All of these are potentially associated with a future risk for cardiovascular problems such as heart disease and stroke.

Drs Kennedy and Khan wanted to investigate whether these abnormalities were also present in children with ME/CFS, given the potential long-term consequences for cardiovascular risk. Risk factors such as high cholesterol and increased blood pressure, which are usually associated with adult diseases, have also been found in children and can progress into adulthood as hypercholesterolaemia and hypertension, so it is important that risks are identified as early in life as possible.

Twenty-five children with ME/CFS (all between the ages of 10 and 18 years) and 23 healthy children matched for age, gender and stage of puberty were recruited from throughout the UK. The diagnosis of ME/CFS had been made according to a revised version of the CDC-1994 case definition, and was confirmed by the researchers from a clinical examination.

A blood sample was taken from each child (using an anaesthetic cream to minimise their discomfort), and this was then subjected to a battery of tests in Dr Kennedy’s laboratory. The child’s blood pressure was measured, and then the pulse at their wrist was detected using a special pen-like probe applied lightly to the skin. This records the fluctuations in pressure as each pulse travels along the artery, and is exactly what you feel with your finger when you take your own pulse. This recording of the pulse is then analysed on a computer to give information on how flexible the artery is, which gives an indication of its health and function.

Overall, compared with healthy control children, the young people with ME/CFS had:

1.Higher levels of oxidative stress, manifested as elevated levels of isoprostanes
2.Reduced levels of vitamins C and E
3.A greater percentage of white blood cells undergoing apoptosis
4.A trend towards increased arterial stiffness, although this was not statistically significant

As Dr Kennedy points out, the increased oxidative stress may be due to a deficiency of antioxidants in the diet (such as vitamins C and E, found to be reduced in this study). However, she feels it is more likely to have been caused by white blood cells releasing an excessive amount of highly reactive free radicals, possibly from exercising muscle. This would tie in with the finding of increased white cell apoptosis, and Dr Kennedy has previously reported increased oxidative stress following exercise in adults with ME/CFS. She does emphasise, however, that more studies, perhaps including an assessment of diet, are needed to determine this mechanism.

The increased apoptosis (or programmed cell death) may be caused by a number of factors, including a persistent viral infection or toxic agent, or an abnormal immunological response. This finding is particularly intriguing given that many patients, including most children in this study, report that their disease started following a viral infection of some kind. At present, however, there is insufficient evidence to make a causal link between infection and increased apoptosis, though the finding is tantalising.

Although there were no other statistically significant changes in the children with ME/CFS, there was a clustering of markers such as arterial stiffness and cholesterol that showed small changes which may indicate the possibility of future cardiovascular risk. This type of clustering has been shown before in healthy children and in young people with diabetes. Although it should be stressed that children with ME/CFS are at no immediate risk of developing cardiovascular problems, we might expect these changes to become greater (closer to the adult pattern) as the children grow older and have been ill for longer.

Dr Kennedy and her team conclude their report by saying that the findings show that many children with ME/CFS “have an underlying, detectable abnormality in the behaviour of their immune cells, consistent with an activated inflammatory process”, and provide evidence of “a persistent or reactivating viral infection triggering apoptosis of white blood cells with an increased production of free radicals”.

It is important that these abnormalities have now been recognised in children with ME/CFS. To date, aside from symptomatic treatments, no specific therapy is available for children or adults with ME/CFS. Based on these and other biomedical findings in the disease, putative therapies could perhaps include both pharmacological and non-pharmacological strategies (to treat dysautonomia, for example), or antioxidant or antiviral interventions.

Co-funders of the study
ME Research UK funds biomedical research into ME/CFS with the aim of finding the cause of the illness and developing effective treatments. It funds the work of a growing number of scientists in the UK and worldwide, and to date has invested over £600,000 to support biomedical research. We are particularly grateful to the ME organisations which have provided larger donations to help us fund specific projects, details of which including some of the resulting scientific papers can be found on our research pages.

The Young ME Sufferers (Tymes) Trust, one of the major co-funders of the study at the University of Dundee, is the longest established national UK service for children and young people with ME and their families. A well-respected national charity, which recently won the Queen’s Award for Voluntary Service, its entire professional team give their time free of charge. It runs an Advice Line, provides access to ME experts for doctors, teachers and social workers, and produces a magazine for children, families and professionals. The Trust played a major role in producing the children’s section of the Department of Health Report on CFS/ME (2002). It promotes interactive virtual education for children with ME, and provides the Tymes Trustcard — a pass card for children in school, endorsed by the Association of School and College Leaders. More information on the Tymes Trust and its work can be obtained at its website.

Search ME, based in Rosyth, Fife, was founded in 2002. Its aims are to improve the lives of people with ME and to provide them with a voice on the Cross Party Group for ME in the Scottish Parliament. The charity has raised the bulk of its donations through organising Rock and Pop Concerts. Search ME became an early supporter of the study at the University of Dundee and helped fund the work carried out there. Members of the charity are very proud of the work carried out at Dundee and of all the people involved. Further information can be found on their website.

Tenovus Scotland has funded world class cancer research across the UK for over 40 years, providing a vital link by funding pilot studies which can attract further support from major funding bodies such as the Wellcome Trust, the MRC, Cancer Research UK, the British Heart Foundation and many others. Further information can be found at its website.

 

Vol. 164 No. 9, September 2010  |  Journal of Archives of  Pediatriatrics & Adolescent Medicine 

Biochemical and Vascular Aspects of Pediatric Chronic Fatigue Syndrome
Gwen Kennedy; Faisel Khan; Alexander Hill; Christine Underwood; Jill J. F. Belch
Arch Pediatr Adolesc Med. 2010;164(9):817-823.
ABSTRACT | FULL TEXT | PDF  [Free Abstract, Payment required for full paper]

http://archpedi.ama-assn.org/cgi/content/abstract/164/9/817 

Abstract 

Biochemical and Vascular Aspects of Pediatric Chronic Fatigue Syndrome
Gwen Kennedy, PhD; Faisel Khan, PhD; Alexander Hill, PhD; Christine Underwood, MBBS; Jill J. F. Belch, MD 

Arch Pediatr Adolesc Med. 2010;164(9):817-823. doi:10.1001/archpediatrics.2010.157   

Objective To evaluate the biochemical and vascular aspects of pediatric chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). 

Design Cross-sectional clinical study. 

Setting Tayside, Scotland, United Kingdom. 

Participants Twenty-five children with CFS/ME and 23 healthy children recruited from throughout the United Kingdom. 

Interventions Participants underwent a full clinical examination to establish a diagnosis of CFS/ME and were asked to describe and score their CFS/ME symptoms. Biochemical markers were measured. Arterial wave reflection was estimated to assess systemic arterial stiffness. 

Main Outcome Measures Markers of oxidative stress and free radicals, C-reactive protein level, white blood cell apoptosis, and arterial wave reflection. 

Results Children with CFS/ME had increased oxidative stress compared with control individuals (isoprostanes: 252.30 vs 215.60 pg/mL, P = .007; vitamin C, mean [SD]: 0.84 [0.26] vs 1.15 [0.28] mg/dL, P < .001; vitamin E, 8.72 [2.39] vs 10.94 [3.46] µg/mL, P = .01) and increased white blood cell apoptosis (neutrophils: 53.7% vs 35.7%, P = .005; lymphocytes: 40.1% vs 24.6%, P = .009). Arterial stiffness variables did not differ significantly between groups (mean augmentation index, –0.57% vs –0.47%, P = .09); however, the derived variables significantly correlated with total (r = 0.543, P = .02) and low-density lipoprotein (r = 0.631, P = .004) cholesterol in patients with CFS/ME but not in controls. 

Conclusions Biomedical anomalies seen in adults with CFS/ME—increased oxidative stress and increased white blood cell apoptosis—can also be observed in children with clinically diagnosed CFS/ME compared with matched controls. Unlike in their adult counterparts, however, arterial stiffness remained within the reference range in these pediatric patients. 

Author Affiliations: Vascular and Inflammatory Diseases Research Unit, The Institute of Cardiovascular Research, Centre for Cardiovascular and Lung Biology, Division of Medical Sciences, Ninewells Hospital and Medical School, Dundee, Scotland, United Kingdom. 

 

Additional papers and Editorial in current edition: 

http://archpedi.ama-assn.org/ 

Adolescent Chronic Fatigue Syndrome: A Follow-up Study
Stefan M. van Geelen; Rob J. Bakker; Wietse Kuis; Elise M. van de Putte
Arch Pediatr Adolesc Med. 2010;164(9):810-814.
ABSTRACT | FULL TEXT | PDF  [Free Abstract, Payment required for full paper]

Abstract

Adolescent Chronic Fatigue Syndrome
A Follow-up Study

Stefan M. van Geelen, MPhil; Rob J. Bakker, MD; Wietse Kuis, PhD, MD; Elise M. van de Putte, PhD, MD

Arch Pediatr Adolesc Med. 2010;164(9):810-814. doi:10.1001/archpediatrics.2010.145

Adolescent Chronic Fatigue Syndrome
A Follow-up Study

Stefan M. van Geelen, MPhil; Rob J. Bakker, MD; Wietse Kuis, PhD, MD; Elise M. van de Putte, PhD, MD

Arch Pediatr Adolesc Med. 2010;164(9):810-814. doi:10.1001/archpediatrics.2010.145

Objective To describe the symptomatic and educational long-term outcomes, health care use, and risk factors of nonrecovery in adolescent chronic fatigue syndrome (CFS).

Design Follow-up study.

Setting Academic pediatric hospital.

Participants Sixty adolescents with CFS.

Interventions Regular care.

Outcome Measures The Checklist Individual Strength, Child Health Questionnaire, and a general questionnaire regarding further symptoms, school attendance, work attendance, and treatment.

Results Complete measurements were returned for 54 adolescents (90%). At initial assessment, their mean (SD) age was 16.0 (1.5) years and 20.4% were male. The mean follow-up duration was 2.2 years. At follow-up, the mean (SD) age was 18.2 (1.5) years; 28 adolescents (51.9%) had nearly complete improvement of symptoms but 26 (48.1%) did not experience improvement. Adolescents who attended school (n = 41) had missed an average of 33% of classes during the last month. The rest (n = 13) had worked an average of 38.7% of a full-time job during the last month. A total of 66.7% of subjects were treated by a physiotherapist, 38.9% were clinically treated in rehabilitation, 48.1% had received psychological support, and 53.7% had used alternative treatment.

Conclusions About half of the adolescents had recovered from CFS at follow-up. The other half was still severely fatigued and physically impaired. Health care use had been high, and school and work attendance were low. Older age at inclusion was a risk factor, and pain, poor mental health, self-esteem, and general health perception at outcome were associated with an unfavorable outcome. Future research should focus on customizing existing treatment and studying additional treatment options.

Author Affiliations: Department of Pediatrics, University Medical Center Utrecht, Utrecht, the Netherlands.

http://archpedi.ama-assn.org/ 

http://archpedi.ama-assn.org/cgi/content/abstract/164/9/803

Postinfectious Fatigue in Adolescents and Physical Activity
Yue Huang, PhD; Ben Z. Katz, MD; Cynthia Mears, DO; Gary W. Kielhofner, DrPH; Renée Taylor, PhD

Arch Pediatr Adolesc Med. 2010;164(9):803-809.doi:10.1001/archpediatrics.2010.144

ABSTRACT | FULL TEXT | PDF | FREE APAM JOURNAL CLUB SLIDES  [All free access]

Abstract

Objective To compare adolescents who do and do not recover from acute infectious mononucleosis in terms of fatigue severity and activity levels before, during, and in the 2 years following infection.

Design Prospective case-control study.

Setting The baseline and 12- and 24-month evaluations occurred in the subjects’ homes. The 6-month outpatient visit occurred at Children’s Memorial Hospital in Chicago, Illinois.

Participants  Three hundred one adolescents (aged 12-18 years) with acute infectious mononucleosis.

Main Exposures All participants were evaluated at baseline (during active infection). Six months following infection, 39 of them met criteria for chronic fatigue syndrome. These subjects were matched by sex and Tanner stage to 39 randomly selected screened-negative subjects. Both groups were reevaluated at 12- and 24-month follow-ups.

Outcome Measures Scores from the Fatigue Severity Scale and the Modifiable Activity Questionnaire.

Results  For both groups, physical activity levels declined and sleep increased as a result of having mononucleosis. Compared with their matched controls, adolescents with chronic fatigue syndrome reported significantly higher levels of fatigue at all points and spent significantly more time sleeping during the day 6 and 12 months following infection. The 2 groups did not differ significantly in terms of physical activity levels before, during, or after infection. There was a consistent trend for decreased physical activity in the chronic fatigue syndrome group.

Conclusions Adolescents with chronic fatigue syndrome appear to be pushing themselves in an attempt to maintain similar activity levels as their peers, but paying for it in terms of fatigue severity and an increased need for sleep, particularly during the day.

Author Affiliations: Department of Occupational Therapy, College of Applied Health Sciences, University of Illinois at Chicago (Drs Huang, Kielhofner, and Taylor); and Department of Pediatrics, Northwestern University Feinberg School of Medicine and Children’s Memorial Hospital (Drs Katz and Mears), Chicago, Illinois.

Editorial Vol. 164 No. 9, September 2010

Full Text

Chronic Fatigue Syndrome in Adolescence: Where to From Here?
Vollmer-Conna
Arch Pediatr Adolesc Med.2010; 164: 880-881. 

Extract Editorial [First 150 words]   

Chronic Fatigue Syndrome in Adolescence: Where to From Here?
Extract | Full Text
http://archpedi.ama-assn.org/cgi/content/short/164/9/880 

Ute Vollmer-Conna, PhD 

Arch Pediatr Adolesc Med. 2010;164(9):880-881. doi:10.1001/archpediatrics.2010.149 

Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings. 

Chronic fatigue syndrome (CFS) is a disabling disorder that poses a significant personal and economic burden for patients, their families, and the community. It is increasingly recognized that CFS is prevalent in children and adolescents.1-2 In the young, the disability associated with CFS can be exacerbated by the effect of the illness on emotional and social aspects of development including social learning, autonomy, a sense of self, a healthy body image, relationships, sexuality, and academic development.3 

After decades of hypothesis-driven research, the etiology and pathophysiology of CFS remains obscure, and curative therapies are not available. What have we learned from this poor outcome? For one, many now agree that the diagnostic label of CFS encompasses a heterogeneous group. This is supported by evidence from several studies (including one pediatric study2) showing that 3 to 5 distinct subclasses can be delineated from large, cross-sectional samples of individuals . . . [Full Text of this Article]  [Payment required] 

AUTHOR INFORMATION 

School of Psychiatry, University of New South Wales, Sydney, Australia 

—————– 

BBC  |  BBC Scotland Health Correspondent  |  7 September 2010  

Study shows ME/CFS ‘virus link’ found in children 

By Eleanor Bradford 

A study on children has found further evidence that ME, or Chronic Fatigue Syndrome, could be caused by a virus. 

Scientists at the University of Dundee study found abnormalities in the white blood cells of children with ME/CFS, suggesting they had been fighting off infection… 

…In the study, funded by ME Research UK and The Young ME Sufferers (Tymes) Trust, 25 children aged between seven and 14 with ME/CFS were assessed, along with 23 children of a similar age in a control group. 

The report, published in the Archives of Paediatrics and Adolescent Medicine, said abnormalities were found in the blood of all the children with ME/CFS. 

The results were similar to those previously identified in adults with the condition. 

Samples taken from youngsters with ME/CFS contained higher than normal levels of free radicals – molecules that can damage cells, tissues and organs… 

Read full article here 

—————– 

From Jane Colby  |  The Young ME Sufferers Trust  |  7 September 2010 

MAY BE REPOSTED 

There should be quite a bit of coverage today of the new research in children, which The Young ME Sufferers Trust co-funded. I’ve done Radio 5 Live and BBC Northern Ireland radio so far.  BBC Wales coming up. Prof Jill Belch has done interviews about the science for a number of channels. 

I wasn’t able to say anything about this yesterday due to reporting restrictions. Will send out an Alert about the research later today. 

Jane Colby
Executive Director
The Young ME Sufferers Trust
PO Box 4347
Stock Ingatestone
Essex CM4 9TE
Tel 0845 003 9002
www.tymestrust.org

Lightning Process: further statement from ME Association and Young ME Sufferers Trust

Lightning Process: further statement from ME Association and Young ME Sufferers Trust

Shortlink: http://wp.me/p5foE-35q

Lightning Process: further statement from ME Association and Young ME Sufferers Trust

Wednesday, 01 September 2010 09:08

On 4 August 2010 The ME Association and The Young ME Sufferers Trust (Tymes Trust) issued a joint statement that expressed a number of concerns about the proposal to carry out a feasibility study, involving children and adolescents with ME/CFS, into the use of the Lightning Process.

The statement can be read here.

We also sent a copy of this statement to the Department of Health with a request that it should be forwarded to the ethics committee that will be examining this proposal. This is because we believe the ethics committee should be aware of widespread concerns being expressed by people with ME/CFS about the trial. Our statement also contained information about an adjudication from the Advertising Standards Authority and interventions by several trading standards officials – both in relation to therapeutic claims being made for the Lightning Process which we believe the ethics committees must be aware of when reviewing this proposal.

The Department of Health have refused to forward this information to the ethics committee on the grounds that

“We expect research ethics committees to consider all the relevant evidence, but they have to be seen do so objectively and impartially and to arrive at their decisions independently if they are to command public confidence and the credibility of all the stakeholders concerned. For this reason, it would be inappropriate, as well as potentially counterproductive, expressly to bring your joint statement to the attention of the research ethics committee reviewing the proposal for this project..”

We profoundly disagree with the DoH’s reasoning, which we consider carries serious implications for the integrity of the scientific process. Whether or not an ethics committee membership is confidential, it should still be possible for essential evidence to be supplied to them. How else can the public be assured that an ethics committee has all the relevant evidence to consider before reaching its decision?

The two charities are unable to forward this statement direct because the identity and location of the relevant ethics committee is not in the public domain.

We are now considering what further action to take.

[Ends]

Text version: Review of Invest in ME proposal for a ‘Centre of Excellence for ME’ in Norfolk

Text version of Review of the Invest in ME proposal for a ‘Centre of Excellence for ME’ in Norfolk by Chris Douglas

Shortlink to this posting: http://wp.me/p5foE-34M

or http://tinyurl.com/ReviewIiMEProposalText

For the Word file of this document and related information go here:

Review of the Invest in ME proposal for a ‘Centre of Excellence for ME’ in Norfolk

 

TEXT VERSION

Review of the Invest in ME proposal for a ‘Centre of Excellence for ME’ in Norfolk

By Chris Douglas

27 August 2010

Introduction

In August 2010, Invest in ME (IiME) published a document titled: ‘A New Era in ME/CFS Research: An Opportunity for Major Progress in Diagnosis, Treatment and Research into Myalgic Encephalomyelitis’¹.

It is assumed that this document is a precursor to a more formal and detailed proposal that will be used to secure consultative input and financial commitment to the project.

The following review highlights specific areas in which the proposal could be strengthened if, in particular, it is to maximise commitment from potential financial donors.

1. Scope
2. Objectives
3. Service Provision Model
4. Funding
5. Conflicts of Interest

1. Scope

1.1. Geographic Scope

The scope of a proposal has direct bearing on project objectives and methodology and provides a framework within which the project can be assessed.

In the current proposal, it is unclear whether the Centre is aimed at servicing the Norfolk region only or the UK as a whole (which, presumably, would include Scotland and Northern Ireland). For example, there is reference to a “national centre of excellence for ME” whilst also discussing East Anglia as being a ‘region of opportunity’.

In particular, it is unclear whether there is a distinction in national and regional service provision between the separate clinical and research facilities detailed in the proposal (and located in Norfolk and Norwich University Hospitals, and the University of East Anglia/Norwich Research Park respectively).

If the clinical service is intended to be national, the following questions arise.

Why has Norwich been selected as a location (given that it has poor logistical accessibility for the rest of the country)?
Have other geographic locations and facilities been considered?
If so, how has their suitability been assessed and by whom?

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For both a national and regional remit, the following questions arise for the clinical service.

Why have Norfolk and Norwich University Hospitals (N&NUH) been selected to host the Centre’s clinical facility?
What specific types and levels of expertise would N&NUH bring to the Centre?
Does N&NUH health care staff have the capabilities and infrastructure to deliver the proposed service and, if not, how would this be addressed?
Have other facilities been considered?
If so, how has their suitability been assessed and by whom?

For a national and/or regional remit, the following questions arise for the research service.

What is the rationale for selecting the University of East Anglia/Norwich Research Park (UEA/NRP) to run the Centre’s research programme?
Has the UEA/NRP submitted a formal proposal for hosting the research programme?
If so, who has assessed this and how has it been assessed?
Have other research facilities been asked to submit proposals?
If so, who has assessed these and how have they been assessed?

The distinction between a national and regional service is further confused by the assumption that the Centre’s ‘translational’ model can be achieved only where the clinical and research services share the same geographic location.

The rationale for this assumption is unclear and, indeed, is contrary to the existing health care provision framework in the UK which operates through a countrywide network of medical facilities within (or co-ordinated by) the National Health Service (NHS).

1.2. Disease Scope

The document uses the nomenclature ‘ME’ (myalgic encephalomyelitis) to describe the condition that it intends to cover although there are further associated illnesses that overlap with ME and, indeed, may actually be the same disease (e.g. fibromyalgia, atypical MS, atypical lupus).

In addition, the UK medical profession uses other terms to describe ME, including Post Viral Fatigue Syndrome (PVFS), Chronic Fatigue Syndrome (CFS) and even just chronic fatigue.

The UK medical profession also lacks clarity and consistency in disease definition and diagnosis, an issue which, as pointed out in the proposal, can lead to patients being diagnosed incorrectly (either as having ME when they do not or not having ME when they do).

To avoid the considerable confusion and inaccuracy of existing nomenclature, definition and diagnosis, it may be preferable to adopt the term ‘neuroimmune disease’, as used by the US Whittemore Peterson Institute (WPI) which the proposal states is a role model for the Centre.

Page 3 

This may also avoid the potential confusion between the Centre of Excellence and existing NHS ME/CFS Centres (referred to in the proposal) which attract criticism for, amongst other things, their lack of biomedical intervention and focus on occupational and behavioural therapies.

In addition, this would provide a platform for further research into the human gammaretrovirus (HGRV) family which has been linked with ME and is the current focus of the WPI. The current proposal does not make reference to this retrovirus and this would seem an oversight given (a) the growing scientific interest in this area and (b) that donors to IiME’s Biomedical Research Fund approved support of the WPI’s UK study of HGRVs. It is also highly relevant for diagnostic purposes (a key focus of the proposal) given the likelihood that HGRVs will become, at very least, a biomarker for ME.

2. Objectives

Successful projects are underpinned by objectives which are specific, quantified, achievable and measurable.

The current proposal omits specific, quantified objectives or project ‘deliverables’, possibly because these are difficult to define given the lack of a precise scope.

Once the scope has been clarified, it may help to establish an overarching mission, a set of objectives and a timeline for implementation.

Given that this is a start-up project with a limited budget (see 4. Funding), it may be prudent to begin with a limited remit that can be met within a short lead-time and then used as a basis from which to develop more ambitious plans.

An example clinical mission would be: ‘To translate international biomedical research findings and therapies into clinical treatments for patients in Norfolk.’

Clinical objectives could include:

– to diagnose and treat x number of patients over time period y
– to deliver xx% improvement in patient health and well-being over time period y
– to train x number of N&NUH doctors in the diagnosis and treatment of ME over time period y

An example research mission would be: ‘To implement research programmes that complement and support those of the WPI.’

Research objectives could include:

– to complete x number of studies (by specified type) over time period y
– to replicate/validate findings of research study z
– to test the efficacy of treatments a, b and c over time period y

The proposal lists eleven project benefits and certain of these could be classed as deliverables (e.g. domiciliary services) but would require greater detail based on a

Page 4

quantified top line objective (e.g. diagnosis and treatment of a specified number of housebound patients pa).

All objectives would require an accompanying plan for delivery and methods of measurement and assessment.

3. Service Provision Model

In the absence of specific and robust objectives to use as a benchmark, it is difficult to assess the potential outcome efficacy of the proposed service model although questions about operational efficiency can be raised at this stage.

The diagram in figure 1 is a graphic representation of the service provision model described in the proposal. The shaded organisations are those which, combined, form the Centre of Excellence.

Fig 1. Overview of assumed service provision model

The proposal describes this as a “simple but effective structure”, although it could be argued that the model is, actually, quite complex given the number of stakeholders and communication pathways that are involved.

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In addition, four separate organisations and geographic locations constitute the Centre of Excellence itself, which makes it a concept rather than a single entity, and so conflicts with the proposal’s underlying theme of a closely integrated operation.

The responsibilities of each of the organisations within the Centre are unclear from the proposal, as are how they will inter-relate and how communication and control will be managed.

In particular, the proposal requires more detailed explanation of the roles of Norfolk PCT and N&NUH, not only in terms of how they may provide patient services regionally and/or nationally, but also in terms of their potential model for other PCTs and hospital trusts to follow, as well as their operation within the NICE (National Institute for Health and Clinical Excellence) guidelines for treating ME.

The proposal states that “a new commissioning director at Norfolk PCT…is supporting the steering group’s views”. It would be helpful to name the individual in question and also include their input in detail.

The position of a ‘clinical biomedical lead consultant’ is mentioned and also that candidates have been approached for this role, although their remit and responsibilities, selection and measurement criteria, and reporting structure are not explained. Similarly, it is unclear how the ‘GPs with special interest’ who support the lead consultant will be identified, enrolled, trained and funded.

The proposal recognises the critical importance of training health care staff (and also mentions ‘visiting experts’) although it is unclear who will be responsible for training the N&NUH staff, which staff will be trained and how training will be implemented and monitored.

Staff training will be paramount to the Centre’s success, particularly given the NHS’ current dearth of biomedical knowledge about ME and its inappropriate and, sometimes, harmful treatment options for the disease (as per the NICE guidelines, mentioned above). IiME needs to demonstrate that the NHS’ long established and entrenched misunderstanding of ME can be corrected, and swiftly, if the Centre is to gain the confidence of patients and commitment of financial donors.

With specific reference to IiME’s involvement in the project, the proposal would benefit from more detailed explanation of the following.

For each of the three IiME entities (charity, limited company and steering group):

– role
– management structure
– governance
– overlap with the other two entities

For the charity and steering group specifically:

– members and/or trustees (other than the two named in the proposal)
– how members/trustees are appointed
– who appoints members/trustees
– to whom members/trustees are accountable
– how members/trustees are monitored

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For IiME Ltd specifically:

– when the company was/will be incorporated
– business classification and trading objectives
– share structure and ownership
– board members and responsibilities
– relationship with Norfolk PCT and N&NUH (given that the proposal refers to IiME Ltd supporting service commission by the former from the latter)

In addition, it would be helpful to understand how the Centre’s work might be integrated with that of other ME research organisations such as ME Research UK (currently funding a HGRV study in Sweden), the UK CFS Research Foundation (supporter of Dr Jonathon Kerr’s research for many years), as well as with its stated role model, the US WPI.

4. Funding

The proposal omits a top line funding requirement, a budget break-down and a cost-benefit analysis for the project.

Norwich local newspaper, EDP24, has stated: “Discussions will be going on over the next few months and once a decision has been made, funding will begin to the tune of £150,000 a year.”²

This amount seems low in the context of the proposed service provision model and particularly in comparison to the Center for Molecular Medicine (home of the WPI at the University of Nevada) which cost $77 million to establish.

The proposal states that funding for research would be “organised and provided by the charity and the UEA” although there is no further detail of how this would be supported nor who would fund the clinical element.

As a consequence, the following information remains to be confirmed.

The estimated cost (overall and breakdown) of establishing and maintaining the Centre over a given time period (for example, five years).

The share and source of funding to be provided by each of the organisations involved in the Centre.

How the funds will be raised by each of the contributing organisations.

Methods for monitoring expenditure, measuring outcomes and reporting to fund contributors.

For those funds raised via IiME (the charity), whether donors will contribute to the Centre as a whole or to specific research and/or clinical projects.

For IiME (the charity), the share of funding to be sourced via the following:

– general donations to the charity;
– profits from sale of IiME’s annual conference DVD;

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– donations to IiME’s Biomedical Research Fund;
– donations to a separate Centre specific fund.

•  Whether, after completion of the WPI’s UK study, any residual monies in IiME’s Biomedical Research Fund will be transferred to the Centre or remain in the Fund for further research projects, and whether donors’ approval will be sought for either course of action (as per the precedent set when monies were reallocated from Dr Kerr’s withdrawn research to the WPI’s UK study).

5. Conflicts of Interest

Fund donors may wish to see further explanation for, and clarification of, the following potential conflicts of interest.

Dr Ian Gibson’s involvement in this project will raise concerns with those who did not welcome his unofficial ‘Gibson Inquiry’ into ME (as referenced in the proposal) and the subsequent uncorrected ‘e-report’ which was published in October 2006³. There were significant criticisms of the way that Dr Gibson and his panel undertook this inquiry (which was a personal project and not a formal Parliamentary Inquiry or Report), such as the involvement of Lord Turnberg, a known supporter of cognitive behavioural therapy (CBT) and graded exercise therapy (GET), and the absence of proper consultation with the inquiry’s constituency of interest at all stages throughout the life of the project. Previously a Labour backbencher, Dr Gibson was barred from standing for the party in the 2010 general election following questions about his ministerial expenses.

Dr Fiona Poland of UEA’s Institute of Health and Social Science Research is working in partnership with Action for ME (AfME) and a network of universities on part of a major ME research project sponsored by the Big Lottery Fund (i.e. reporting and developing early findings on the impact of the illness and available means of support). The association between UEA and AfME will raise concerns with a growing number of patients who openly criticise the latter’s role, agenda and efficacy, particularly in terms of its apparent unwillingness to support biomedical ME research and to challenge the psychosocial paradigm.

The Norwich Research Park is a joint venture between the UEA, and amongst others, the Sainsbury Laboratory which, in turn, is supported by the UEA and the Gatsby Foundation. The Gatsby Foundation is one of a number of Sainsbury Family Charitable Trusts which share the same administrators and counsels. This includes the Linbury and Ashden Trusts which have provided funding for the RNHRD NHS FT, Bath (the ‘Min’) and the University of Bristol’s controversial trial of the Lightning Process on children and for which IiME has stated its public opposition.

The Institute for Food Research (IFR) and The Genome Analysis Centre (TGAC) are institutes of the Biotechnology and Biological Sciences Research Council (BBSRC). The BBSRC grant-aids the John Innes Centre (based in Norwich Research Park) which hosts the Sainsbury Laboratory and the TGAC. BBSRC is one of seven Research Councils that work together as Research Councils UK (RCUK). It is funded from the Government’s Department for Business, Innovation

Page 8

and Skills (BIS). This is a complex organisational structure which makes it difficult to achieve transparency in funding governance and also to identify potential conflicts of interest.

It is unclear from the proposal whether ME support groups in the Norfolk region (or nationally, if the scope is such) are involved in this project and the degree to which they have provided input and support. It is also unclear whether there has been any wide-scale patient consultation for this project or if any is planned in the future.

References

1 Invest in ME proposal for a ‘Centre of Excellence for ME’ in Norfolk August 2010
‘A New Era in ME/CFS Research: An Opportunity for Major Progress in Diagnosis, Treatment and Research into Myalgic Encephalomyelitis’

2 EDP24 “Norwich centre for ME sufferers planned” 03.08.10

3 THE ONE CLICK GROUP REPORT THE GIBSON ‘INQUIRY’ 17 January 2007

 

Chris Douglas is an ME sufferer and ex-corporate project manager.

douglas_chris@hotmail.co.uk

© Chris Douglas 2010

ME Association Summary and Statement on Lo et al paper

ME ASSOCIATION SUMMARY AND STATEMENT ON LO et al PAPER:

Detection of MLV-related virus gene sequences in blood of patients with chronic fatigue syndrome and healthy blood donors

Shortlink: http://wp.me/p5foE-33G

Issued 25 August 2010

ME ASSOCIATION SUMMARY AND STATEMENT ON LO et al PAPER:

Detection of MLV-related virus gene sequences in blood of patients with chronic fatigue syndrome and healthy blood donors

Authors: Shyh-Ching Lo (US Food and Drug Administration) et al.

Published in the Proceedings of the National Academy of Sciences (PNAS) on August 23rd 2010.

Pdf available on-line: http://www.pnas.org/content/early/2010/08/16/1006901107.full.pdf+html

Accompanying commentary by Valerie Courgnaud et al: http://www.pnas.org/content/early/2010/08/16/1007944107.full.pdf+html

BACKGROUND:

Murine leukaemia viruses (MLV) are retroviruses known to cause cancer in certain mice. In 2006, investigators found that a type of MLV, called xenotropic murine leukaemia virus-related virus (XMRV), could potentially infect humans after finding it in tissue samples from men with prostate cancer. XMRV is one of a number of MLVs that appear to be transmitted to humans.

In October 2009, Lombardi et al published the results of study in Science which contained evidence that XMRV was present in a high percentage (67%) of people with ME/CFS and in a small percentage of healthy controls.

Since then there has been a great deal of interest from researchers in a number of countries where ME/CFS is recognised. A number of research groups have attempted (or are still attempting) to repeat these positive XMRV findings.

Confirming or refuting new findings is a vital part of the scientific evaluation process and involves other independent research groups trying to either replicate or validate the results.

In relation to XMRV, a true replication study should involve exactly the same laboratory methods and same type of patients that were used in the original Science study. A validation study gives scientists a degree of flexibility. In particular, it provides the opportunity for other research groups to try and repeat the findings using what they feel are the most sensitive and accurate laboratory methods they have access to for testing for XMRV.

In the case of XMRV almost all of the first wave of research has involved validation studies. Firstly, because there is no international agreement about the most accurate and sensitive way of detecting XMRV in blood samples. Secondly, because these research groups all wanted to move quickly, and the easiest way to do so was to use stored blood samples from people who had been diagnosed with CFS in the past according to Fukuda research criteria. Stored blood samples from people who met both Fukuda and Canadian criteria (which were used in the original study) are not readily available.

Results from four emphatically negative validation studies of varying quality – three carried out in Europe and one carried out by the CDC in America – have now been published in scientific journals. Results from a further (so far unpublished) study, carried out by Professor Brigette Huber, were presented at the Invest in ME conference in May 2010 (report available on MEA website and in the August 2010 of ME Essential).

None of these five research groups – which in the case of the UK included Professor John Gow, Dr Kate Bishop, Dr Jonathan Kerr and Dr Jonathan Stoye and used patient samples supplied by physicians and neurologists including Dr Abhijit Chaudhuri and Professor Peter Behan – have been able to find evidence of XMRV in blood samples from ME/CFS patients, or in the healthy controls.

Although some very valid criticisms have been made about all of the XMRV negative studies, in particular the most recently reported one from America, a number of distinguished virologists who work with retroviruses and XMRV have been involved – so these XMRV negative results have to be taken seriously as well.

THE LO et al STUDY

On 23 August 2010 the results from the first follow up study to firmly support a link between a retroviral infection and ME/CFS were published.

This study is clearly an important contribution to the XMRV debate in that it fully supports a link between ME/CFS and retroviral infection. In this respect it also supports the findings in the Lombardi paper.

However, it is not a true replication study, and in the words of the authors they have not attempted to fully replicate the Lombardi et al findings.

Lo et al have used different laboratory methods and different patient criteria and their findings relate to what are called MLV-related viruses.

The research group have found segments of genetic material (not whole virus) from what they term a genetically diverse group of MLV-related viruses. These sequences are more closely related to those of polytropic mouse endogenous (=arising within or derived from the body) retroviruses than to those of XMRVs – hence the use of the term MLV (murine = mouse leukaemia virus) in the title. But they all belong to a closely related family of retroviruses.

PATIENT SELECTION

In contrast to the Lombardi et al study, which involved patients who met both Fukuda research criteria and Canadian Clinical Criteria for CFS, this research used stored blood samples from ME/CFS patients who had been diagnosed using either the 1988 Holmes research criteria or the 1994 Fukuda research criteria. The patients were diagnosed with CFS from the mid 1990s onwards and most of the frozen blood samples were supplied by Professor Tony Komaroff at Harvard Medical School, Boston. Professor Tony Komaroff is a well respected physician with a longstanding interest in ME/CFS. In addition, 12 patient samples came from other US physicians whose diagnostic criteria for ME/CFS is not stated.

The numbers involved were surprisingly small for a study of this nature: 37 patients with CFS and 44 healthy controls.

The healthy control samples came from Washington DC blood donors recruited between 2003 and 2006.

So these results apply to a rather broader group of ME/CFS patients than was used in the Lombardi et al study and the patient sample is probably very similar to at least one of the other validation studies that produced negative findings in relation to XMRV. As with some of the other validation studies, it is highly likely that a significant number of people who also meet Canadian Clinical Criteria will have been included in this study.

RESULTS

MLV-like virus gag gene sequences (in simple terms segments of viral genetic material) were found in 32 out of 37 (86.5%) of the ME/CFS patients compared to only 3 out of 44 (6.8%) of the (blood donor) healthy controls.

Follow-up samples were collected from 8 of the CFS patients in 2010, and 7 of these again tested positive for MLV-like gene sequences.

As already pointed out, the evidence in this paper relates to a genetically diverse group of MLV- related viruses with gene sequences that are more closely related to those of polytropic mouse endogenous retroviruses (mERVs) than to those of XMRV. XMRV is a genetic variant of MLV-like viruses – so this is a subtle but relevant distinction.

The authors point out that they have taken exhaustive steps to try and ensure that they have not produced false positive results as a result of mouse DNA contamination, or any of the other potential laboratory problems that come when working with retroviral infections.

CORRELATION, INFECTION AND POSSIBLE CAUSATION

The authors point out (p5) that the finding of XMRV or MLV genetic sequences in people with ME/CFS, or any other disease, does not constitute definite proof of viral infection.

They then go on to make it clear that further research will be required before any definite conclusion can be drawn as to whether MLV-related viruses play a role in the causation of ME/CFS. This is a process that is going to take time and further research.

They also state (p6), as has been pointed out in previous MEA summaries on XMRV, that a high frequency of MLV-related viruses (or XMRV) in ME/CFS patients could reflect an increased susceptibility to viral infections due to the underlying immune dysfunction found in ME/CFS rather than a primary disease causing role in the pathogenesis of ME/CFS. In other words the retrovirus could just be there as a ‘harmless passenger’.

COMMERCIAL TESTING FOR MCVs and XMRV

The MEA continues to believe that there is no point in spending very large sums of money on arranging blood tests, which may not have been properly validated, for XMRV (or MCVs) outside the UK. Having a positive result is not, in our present state of knowledge, a diagnostic marker for ME/CFS. Equally, having a negative result does not mean that you do not have ME/CFS. Having a positive result will not affect ME/CFS management at present and if this information is inserted into medical records it could in due course cause problems with other health matters such as applications for insurance policies or travel abroad.

The way in which these viruses might be transmitted from person to person also remains uncertain and sexual transmission is one possibility – as in the case of HIV. However, if this is a disease causing virus like HIV, sexual transmission appears very unlikely given the fact that ME/CFS appears to be very rare in sexual partners of people with ME/CFS, even after long periods of time.

BLOOD DONATION

The MEA continues to believe that the current uncertainty over transmission of these viruses/viral segments means that people with a current or past history of ME/CFS should not be donating blood and we have recently written to the acting Chief Medical Officer at the Department of Health to seek clarification on what appears to be a recent decision to extend the UK ban to people who have recovered from ME/CFS. Copy of this correspondence [here]

We find it surprising that the American authorities responsible for blood safety have not followed the UK lead here.

ANTIVIRAL TREATMENT

The authors of this paper make no comment or recommendations regarding the use of antiviral drugs. However, others (including the authors of the accompanying commentary) are now suggesting that it is time to assess the use of antiretroviral therapy (ART) in ME/CFS in some clinical trials. It is well accepted that one way of examining the possible cause of a disease is to assess the response to specific forms of treatment.

The MEA has already pointed out on several occasions that this type of clinical trial would have to proceed with great care given the fact that ARTs can have serious side-effects. In the case of AZT, this drug can cause mitochondrial damage – which is obviously very relevant in ME/CFS. But there are other ARTs becoming available that appear to be active against XMRV and may be much safer to use (eg reverse-transcriptase inhibitors such as tenofovir and emtracitabine).

We have also pointed out that ARTs appear to have very limited effect in reducing fatigue in HIV/AIDS, and that this may be due to the immune system activation that is occurring in this situation rather than any direct effect on reducing the viral load of the HIV infection. So drugs that dampen down immune activity (eg a tumour necrosis factor inhibitor such as etanercept) may be a more appropriate route to follow. More information [here]

In the UK doctors are very unlikely to be willing to prescribe any type of antiviral treatment on an individual (ie non research) basis. This is because the 2007 NICE guideline on ME/CFS specifically recommends that antiviral drugs should not be used to treat ME/CFS. And if anything goes wrong through the use of a potentially toxic antiviral drug, that is in effect banned by NICE, and has not been assessed in a proper clinical trial, the doctor responsible could face legal action even though the patient accepted the risk.

FURTHER RESEARCH AND THE ROLE OF MEA RAMSAY RESEARCH FUND

Investigators at FDA, NIH, CDC and other scientific institutions are in the process of conducting studies to verify the capabilities of the tests used by the different laboratories for the detection of XMRV or MLV-related viruses in blood. These studies are intended to develop and standardise a highly sensitive and specific XMRV test to better study its association with disease, as well as the possibility that XMRV can be transmitted to blood or tissue recipients.

The UK Medical Research Council’s Expert Group on ME/CFS research (of which CS is a member) has identified all aspects of viral infection in ME/CFS (including carefully targeted use of antiviral agents) as a priority item for further UK research and we expect that this recommendation will now be translated into action.

The MEA is again making it clear to UK research groups with expertise in retrovirology, and access to reliable patient samples, that we would very much welcome good quality research applications relating to any aspect of XMRV or MLVs. The MEA is also willing to consider co-funding research applications in this area.

We are in contact with most of the key UK researchers working on XMRV and we are also assisting with a small UK study that is intending to retest people who already have a positive XMRV result as a result of having this test done in America.

We also need to find out how common these new retroviruses are in people with other chronic disabling conditions, especially those that involve immune system dysfunction.

MEDIA REACTION

In America, the paper has been quite widely reported with most of the coverage being supportive. In the UK there has been very little interest in the press release – apart from the Daily Mail (which carried an on-line story) and the New Scientist:

http://www.newscientist.com/article/dn19361-virus-link-with-chronic-fatigue-syndrome-resurfaces.html  

which includes quotes from Professor Myra McClure, one of the UK virologists involved in a negative validation study.

Lack of coverage in the UK is partly because selected health journalists, who might have reported the story, like to have access to a new research paper well before the information enters the public domain – so they have a day or two to chase around and obtain informed comment on the story. Health reporters have finished writing their copy for the next days paper well before 8pm in the evening – so unless there is a real breakthrough news item they are not at their desks in the evening. The US press conference at 8pm UK time did not fit in with their working arrangements for printing something on Tuesday and the findings would be ‘old news’ by Wednesday. In addition, they also had a good headline health scare story for Tuesday morning relating to people being refused an anti-cancer drug due to a NICE ruling.

Unfortunately, there are health correspondents that I speak to on the more influential papers and journals who are now very cautious about covering ME/CFS stories.

OVERALL CONCLUSIONS

In very simple terms the clinical and scientific community regards published papers rather like goals (of varying quality) in a football match. So the current score is XMRV and MLV positive 2 (with a spectacular first goal!): XMRV negative 4 (of varying quality) with plenty of time left before the final score.

The comments so far that I have read, or been given, by experts in this area of virology indicate that everything has been done correctly in this study and that this is a sound piece of laboratory research. However, with differing results from differing well respected retroviral laboratories, the clinical and scientific community is likely remain uncertain or sceptical about the link between retroviral infection and ME/CFS.

Another analogy is fitting pieces into a jigsaw puzzle with a lot of blue sky. We now have six pieces (ie published papers of varying quality) in place and some strong opinions on either side. But a lot of pieces have still to be fitted into the picture.

Overall, there is no sign of any real scientific consensus emerging as to whether XMRV and/or MLVs are playing a significant role in ME/CFS and many key questions regarding prevalence, transmission and pathogenesis remain unanswered. Things may become a bit clearer as a result on the international meeting on XMRV in September, which will include a session on ME/CFS. Proposals for further research may also emerge after this meeting.

This uncertainty and scientific disagreement seems likely to continue until well into 2011 and the current findings are unlikely to have any significant influence on the forthcoming review of the NICE guideline or the increasingly difficult position faced by people with ME/CFS in relation to sickness and disability benefits. [Our most recent correspondence on 24 August from NICE indicates that they have still to decide on the date at which the review will take place, whether it will be a full review – which could take up to a year, or whether they might delay the review to await the results of further research from clinical trials.

More top quality research is clearly needed here in the UK and the MEA is very willing to consider funding it.

ADDITIONAL INFORMATION FROM US FDA:

FDA Question and Answer on the paper: http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm223232.htm

Answers to the final three questions, which are of importance to US readers:

9. Does FDA agree with the AABB recommendation to discourage donation by people with history of CFS?

FDA does not object to the AABB recommendation. The AABB recommendation is consistent with a long-standing position of the Chronic Fatigue and Immune Dysfunction Syndrome (CFIDS) Association of America that individuals with CFS voluntarily should not donate blood.

10. How are the differences between the CDC and FDA study results being evaluated?

Differences in the results could reflect differences in the patient populations that provided the samples. Alternatively, undefined differences in the method of sample preparation could be contributing to the discordant test results. All of the scientists involved are working collaboratively to design experiments to quickly answer this scientifically puzzling question. An independent investigator at the National Heart, Lung, and Blood Institute (NHLBI) set up a test set of 36 samples, including known positives and presumed negatives. Both the FDA/NIH and CDC labs participated in this test, and the results showed that both labs were able to detect XMRV present at low levels in blinded samples. Additionally, the CDC laboratory provided 82 samples from their published negative study to FDA, who tested the samples blindly. Initial analysis shows that the FDA test results are generally consistent with CDC, with no XMRV-positive results in the CFS samples CDC provided (34 samples were tested, 31 were negative, 3 were indeterminate).

11. What do these findings mean to CFS patients and clinicians who treat them?

Although this study found MLV-like viral gene sequences in a high percentage of CFS patients, this does not prove that these retroviruses are the cause of CFS or of any other disease. Moreover, other studies have not found evidence of such retroviruses in patients with CFS. Further studies are necessary to determine if XMRV or other MLV-like viruses are reproducibly associated with CFS, and if so whether the virus is a causative agent or a harmless co-traveler. The different findings from various studies reinforce the need for more research–including careful analysis of other cohorts of CFS patients from different geographic regions, studies of larger populations of healthy people, and testing of transmissibility of the agents through blood transfusions in animal models. FDA, NIH, and CDC have and will continue to collaborate with other agencies and groups involved in this research.

Summary prepared by Dr Charles Shepherd
Hon Medical Adviser, MEA

MEA website: http://www.meassociation.org.uk

NB: There will be a delay in placing this item on the MEA website because our webmaster is away on holiday for the next few days.

25 August 2010

ENDS

Media coverage round up 2: UK media coverage: Alter et al XMRV PNAS paper

Media coverage round up 2: UK media coverage: Alter et al XMRV PNAS paper

(Presence of Murine Leukemia Virus Related Gene Sequences Found in CFS Patients  – XMRV PNAS paper)

Shortlink: http://wp.me/p5foE-32O

For Newswire; Abstract; Full paper; Supporting information; Editorial; Commentary go here:

Study: Presence of Murine Leukemia Virus Related Gene Sequences Found in CFS Patients finally published 

Click here for international media coverage

Updates for UK media coverage will be added to the top of this list:

 

UK patient organisations

The ME Association has said that it will be publishing a commentary later this week.

Action for M.E.

Action for M.E. News release  |  24 August 2010

http://www.afme.org.uk/news.asp?newsid=912

News

M.E.charity calls on MRC to put its money where its mouth is, following new research from States

Action for M.E., the UK’s leading charity for people with M.E., is calling on the Medical Research Council to prioritise research into the link between viral infections and M.E., following the latest findings from the United States.

Scientists at the American Food and Drug Administration, National Institutes of Health and Harvard Medical School have found murine leukemia virus-related viruses (MLVs) in 32 out of a sample of 37 (86.5%) people with chronic fatigue syndrome, compared to 3 out of 44 (6.8%) healthy blood donors.

Chronic fatigue syndrome is also known as M.E. or M.E./CFS.

The findings, published in the Proceedings of the National Academy of Sciences (PNAS) support research from the Whittemore Peterson Institute in Reno, last October, which identified genetic material (DNA) from a mouse virus – murine leukaemia virus-related virus (XMRV) – in 68 out of 101 CFS patients (67%) compared to 8 out of 218 (3.7%) of healthy people.

Action for M.E.’s Chief Executive, Sir Peter Spencer, welcomed the latest news saying, “It is extremely encouraging to see positive results linking different strains of viruses and CFS, after disappointing results from other studies earlier this year.

“However, we cannot afford to leave this to the Americans. M.E. affects 250,000 men women and children in the UK, from toddlers aged two to people in their eighties. Many become so severely affected that they are bedbound or housebound.

“In June, the MRC’s expert group on M.E./CFS identified viral infection as a priority. We now call on the MRC to take this forward in real terms, as a matter of urgency, by allocating a significant level of funding to research in this area.

“There are still many questions to be answered, not least the variations in findings. Large-scale studies involving many more patients are also required.”

Notes to editor

1. The findings published in the Proceedings of the National Academy of Sciences (PNAS) can be found at http://www.pnas.org/content/early/2010/08/16/1006901107.full.pdf+html

2. PR Newswire press release at:
http://www.prnewswire.com/news-releases/study-presence-of-murine-leukemia-virus-related-gene-sequences-found-in-cfs-patients-101316939.html

3. October 2009 research from the Whittemore Peterson Institute can be found at:
http://www.cfids-cab.org/rc/Lombardi.pdf

4. The June 2010 MRC CFS/ME Research Prioritisation Meeting details may be found at: http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC007174

5. Action for M.E. is the UK’s largest charity for people with M.E. and more about the illness may be found on its website, www.afme.org.uk

 

UK media coverage:

Daily Mail  |  24 August 2010  |  Claire Bates

http://www.dailymail.co.uk/health/article-1305691/Chronic-fatigue-syndrome-caused-mouse-related-virus.html

Chronic fatigue syndrome ‘may be caused by mouse-related virus’

Chronic fatigue syndrome may be caused by a rare mouse-related virus, new research suggests.

Scientists found evidence of murine leukaemia virus – known to cause cancer in mice – in 86 per cent of chronic fatigue patients.

However, traces from this family of bugs were only found in seven per cent of samples from healthy blood donors. It adds to the growing body of evidence that an infection could play a role in the complicated illness.

Read more

 

Quote from UK Imperial College London, retroviralist, Prof Myra McClure, co-author of:

Failure to Detect the Novel Retrovirus XMRV in Chronic Fatigue Syndrome

“Let’s be clear: This is another virus. They did not confirm [Mikovits’s] results,” says retrovirologist Myra McClure of ICL, a co-author of one of the four negative studies…”

http://news.sciencemag.org/sciencenow/2010/08/second-paper-supports-viral-link.html
Second Paper Supports Viral Link to Chronic Fatigue Syndrome
by Martin Enserink on August 23, 2010 4:02 PM

“…The data do seem solid, admits Steve Monroe, who co-authored the conflicting CDC paper. “It’s simply a good paper,” adds Reinhard Kurth, the former director of the Robert Koch Institute in Germany, who helped test some of CDC’s samples and did not find the virus either. Alter—a widely respected virologist and winner of the Albert Lasker Award for Clinical Medical Research—”clearly knows what he is doing. They did everything correctly,” says Kurth, who nonetheless says he remains skeptical.

So too does virologist Robin Weiss of Imperial College London (ICL), who says he’s seen too many instances of proposed new human retroviruses that fell apart on closer inspection, including one he reported in arthritis and lupus patients in 1999 that turned out to be an innocuous rabbit virus. (In a 40-page review that he co-authored in 2008, Weiss called such mishaps “human rumor viruses.”) “You can have a very good reputation and be very careful and still get it wrong,” Weiss says.

Part of the problem, skeptics say, is that the researchers didn’t exactly replicate the Science paper. XMRV is a so-called xenotropic murine virus, which means it can no longer enter mouse cells but can infect cells of other species. (Murine means “from mice.”) The researchers in the PNAS paper say the viral sequences they find are more diverse than that and resemble more closely the so-called polytropic viruses, which is why they adopted the term MLV-related virus, for murine leukemia virus. “Let’s be clear: This is another virus. They did not confirm [Mikovits’s] results,” says retrovirologist Myra McClure of ICL, a co-author of one of the four negative studies…”