Chronic Fatigue Syndrome Advisory Committee (CFSAC) Presentations 10-11 May 2011

Chronic Fatigue Syndrome Advisory Committee (CFSAC) Presentations May Meeting 10-11 May, Public and Written Testimony

Shortink: http://wp.me/p5foE-3iw

The next meeting of the Chronic Fatigue Syndrome Advisory Committee (CFSAC) takes place on Tuesday and Wednesday, 10 and 11 May 2011.  A copy of the Agenda for this meeting will be posted as soon as it becomes available.

Chronic Fatigue Syndrome Advisory Committee (CFSAC)

The Chronic Fatigue Syndrome Advisory Committee (CFSAC) provides advice and recommendations to the Secretary of Health and Human Services via the Assistant Secretary for Health of the U.S. Department of Health and Human Services on issues related to chronic fatigue syndrome (CFS).

The meeting agenda is not yet available but a list of those who have registered to give Public Testimony and who have submitted Written Testimony has been posted on the CFSAC website on this page:

http://www.hhs.gov/advcomcfs/meetings/presentations/05102011.html

It is hoped that the issue of proposed codings for the forthcoming US specific Clinical Modification of ICD-10, which will be known as “ICD-10-CM” and which is scheduled for implementation in October 2013, will have been tabled for further discussion. The CFSAC Recommendation adopted at the May 2010 meeting is problematic and requires further discussion and revision.

See: Dx Revision Watch posts:  

“CFS orphaned in the “R” codes in US specific ICD-10-CM”: http://wp.me/pKrrB-V4

“The clock is ticking for CFS: Partial Code Freeze for ICD-9-CM and ICD-10-CM/PCS Finalized (US)”: http://wp.me/pKrrB-Un

 

Chronic Fatigue Syndrome Advisory Committee (CFSAC) Presentations
May 10-11, 2011
Room 800, Hubert H. Humphrey Building
200 Independence Ave, S.W.
Washington, D.C. 20201

Meeting Materials
Recommendations Chart

Public Testimony

Tuesday, May 10, 2011

Baker, Keith [PDF, 12 kb] PDF available from CFSAC site
Landson, Joseph D.
Manganaro, Kathleen

Wednesday, May 11, 2011

Smith, Rachel [PDF, 15 kb] PDF available from CFSAC site
Chapo-Kroger, Lori

Written Testimony Received Prior to the Meeting Date

Anonymous 1
Anonymous 2
Anonymous 3
Chu, Lily
Danek, Peg
DiPasquale, Ben
Drasner Haban, Johanna I.
Fairman, Matthew
Farrell, Tracy [PDF, 11 kb] PDF available from CFSAC site
Jackson, Ken
Jackson, Suzan
Kitei, Mindy
McDermott, Lolly
McGrory Richardson, Nancy
McNamara, Mary E.
Paivanas, Sue A.
Pratt, Danielle
Pressner, Erin
Rachel
Reilly, Esq. Justin
Rogalla, Kathleen
Spinhirne, Jerrold
V. Katie
Vokal, Toby
Wiley, Janelle

Related material

Previous ME agenda post: Heads up: Next meeting of Chronic Fatigue Syndrome Advisory Committee (CFSAC) : http://wp.me/p5foE-3ih

CFSAC Notices

http://www.hhs.gov/advcomcfs/notices/index.html

CFSAC Roster

http://www.hhs.gov/advcomcfs/roster/index.html

CFSAC Meetings

Agenda; Minutes; Presentations; Recommendations

http://www.hhs.gov/advcomcfs/meetings/index.html

Recommendations to the Secretary of Health and Human Services

http://www.hhs.gov/advcomcfs/recommendations/index.html

Previous two meetings:

May 10, 2010 Meeting

Agenda

Minutes

Presentations

Recommendations

Videocast    [RealPlayer is required to view]

CFSAC Recommendations – May 10, 2010

http://www.hhs.gov/advcomcfs/recommendations/05102010.html

October 12, 2010 Science Day
October 13-14, 2010

Agenda

Minutes

Presentations

Recommendations

Videocast    [RealPlayer is required to view]

CFSAC Recommendations – October 13-14, 2010

http://www.hhs.gov/advcomcfs/recommendations/1012-142010.html

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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

Dr Esther Crawley: Transcript of Presentation: The Future of Research in CFS/ME

Dr Esther Crawley: Transcript of Presentation: “The Future of Research in CFS/ME”

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

May be reposted in full or in part, provided it is reposted unedited and a link to source is given. When linking to this post please provide the specific post URL.

The Tiny URL link for this post is: http://tinyurl.com/Crawley-Presentation-March-10

The WordPress Shortlink is: http://wp.me/p5foE-3ay

 

In March, this year, Dr Esther Crawley gave a presentation to a Dorset patient support group entitled “The Future of Research in CFS/ME” during which she also spoke on XMRV research and delivered some very controversial comment on the operation and findings of the Whittemore Peterson Institute (WPI).

It is understood that the presentation was attended by Annette Brooke (MP for Mid Dorset and North Poole) and Vice-Chair of the re-formed APPG on ME.

Below is an unofficial transcript that has been provided to me to supplement the partial transcript ( Dr Esther Crawley discusses XMRV and Whittemore Peterson Institute (WPI), March 2010 ) which was first published on ME agenda, in August.

Care has been taken in the preparation and proofreading of this text; some transcription errors and ommissions may remain.

 

Dorset CFS/ME Society
Annual Medical Lecture

27th March 2010

The Future of Research in CFS/ME

Esther Crawley

It’s a great pleasure to be here, everybody, and I’m really glad actually that my talk actually fits in very nicely with what William’s just said. Phew!

I’m going to be talking a lot about the collaborative research and the first half of my talk actually was given to the MRC Working Group at the end of last year. So you’ll actually see what we were talking about where the MRC gathered lots and lots of researchers together to discuss a way forward with chronic fatigue [sic] and I did the talk on epidemiology. Continue reading

Chutzpah – he’s got it in spades! (Lightning Process and scientific research)

Chutzpah – he’s got it in spades! (Lightning Process and scientific research)

Shortlink: http://wp.me/p5foE-38M

The Phil Parker Lightning Process site announces they are shortly to launch “a public opinion survey designed to raise awareness about current research into the physical nature of this disease”  –  a “Campaign to increase awareness of ME/CFS as a physical illness” with the promise of more information to follow.

 

Mr Parker’s scientific ability to step inside people’s bodies:

This is the man about whom it is claimed…

http://www.healinghawk.com/prospectushealing.htm  

…Phil Parker is already known to many as an inspirational teacher, therapist, healer and author. His personal healing journey began when, whilst working with his patients as an osteopath. He discovered that their bodies would suddenly tell him important bits of information about them and their past, which to his surprise turned out to be factually correct! He further developed this ability to step into other people’s bodies over the years to assist them in their healing with amazing results. After working as a healer for 20 years, Phil Parker has developed a powerful and magical program to help you unlock your natural healing abilities. If you feel drawn to these courses then you are probably ready to join…

That entire course prospectus is worth a skim.
 
 

Mr Parker’s scientific opinion on the Lightning Process and XMRV:

Slide presentation:  xmrv cfs | 8:30 mins

17 slides, no audio

http://www.youtube.com/watch?v=R8GCp00KC78

thephilparker | 27 October 2009
Phil Parker, designer of the Lightning Process discusses the latest research into the xmrv virus and cfs

@ Slides 13 and 14

How this relates to the Lightning Process

• If we assume that on average:

– 67% of the cases of CFS clients that are seen with the LP have the XMRV virus,

– And according to our findings 85% of these people recover their health in the 3 days of the LP programme

LP and XMRV

• The LP must be assisting these people to deal effectively with that infection in some way (we would hypothesise it is a resumption of good immune and neurological function)

 

Mr Parker’s promotion of the “Lightning” as a “Dynamic New NLP Pattern Seminar” and “Self Coaching Strategy”, in 2002:

Yahoo! Groups   hypnosis-hypnotherapy-UK

Tue Apr 23, 2002 3:34 pm

http://health.groups.yahoo.com/group/hypnosis-hypnotherapy-UK/message/3888

Dynamic New NLP pattern seminar

The London College of Holistic Medicine

Presents

The Lightning Self Coaching Strategy

A seminar training you in the latest developments in the fields of NLP and Coaching

Led by Phil Parker Do Dip E Hyp NLP CMPNLP MBIH

and Phil Swallow DCHNLP CMPNLP

Sunday June 16th 10am-5pm Central London,UK

This is a rare opportunity to discover some NEW NLP patterns;

these are as a result of Phil’s latest research and are simply not available anywhere else.

Do you want to build on your current skills and master a simple, effective, rapid and lasting strategy for helping you and your clients to learn how to:

Make changes in issues which have troubled them for years

Breakthrough old areas of stuckness

Stop old negative thought patterns

Develop a more supportive and affirming relationship with themselves

Stop victim behaviour, inaction, lack of responsibility and sulking

Stop abusive patterns like smoking, overeating

Stop worry, anxiety, panic attacks

Get over depression

Become more proactive and less dependent on professional support

Coaching and self coaching.

Most of us are now familiar with concepts of coaching, and recognise the value of this supportive and focused way to address the issues of your life.

Self coaching takes these core coaching concepts even further, rapidly developing the clients own abilities to take charge of the choices they make in their lives, to create solutions to unfamiliar situations, to nurture and support themselves, and focus their lives in the directions they really want to. This detailed course trains you so that you can apply the key steps of this process to teach and coach your clients to mastery in the Lightning Self Coaching Strategy.

You will learn how to use the following Key Steps

Explain to clients how their current negative patterns work; and help them to discover how changing them will produce amazing results

The Lightening Self Coaching process

Testing and fine tuning

Making it stick

Pre-course requirements.

To ensure the course is appropriately targeted, you meet one of the following eligibility criteria

A: a NLP practitioner

B: a Hypnotherapist

C: have a clinically based training, e.g. doctor, nurse, osteopath, acupuncturist etc.

D: have a coaching training

E: had a personal interview with course leader

You will get the most from the course by reading Phil Parker’s groundbreaking handbook on self coaching, The Ten Questions. Available at http://www.philparker.org

Course fee: £120 (please make cheques payable to Phil Parker and mail to LCHM 170 Weston Park London N8 9PN UK)

Early bookers discount; be sure of your place, save yourself £20 and make the admin easier for us by booking before May 1st 2002 and your course fee will only be £100

Clients comments after using the Lightning Self Coaching Strategy.

I’m not quite sure how you’ve help me do this but, but I do not recall feeling so good for decades; the rollercoaster of anxiety and stress that I used to have a season ticket to has just gone away. Thanks so much for teaching me what I wished I’d learnt years ago.

I’ve been the Queen of yo-yo dieting for years. I’ve seen everyone, and I mean everyone, from Nutritionists to fitness trainers to astrologers. Nothing has made any long term impact until I started this process with Phil. Now I’ve been eating normally for 3 months, and not even snacking when the stress starts to build up.

I feel like a genius!

I believed I had a milk allergy causing all my digestive problems, but it seems I was mistaken, not only can I now eat what I like and feel fine, but I’ve also reduced the stress is my life to almost zero, just in three sessions. I can’t believe how good I feel, and how easy it was, and how I never knew any of this work before now.

Warning: There is a strong possibility that your current clients could stop needing to see you as often as they used to and that they will begin refer you more new clients than you can handle.

Reserve your place by mailing a cheque made payable to P Parker to

LCHM,170 Weston Park, London N8 9PN.

For further details call 020 83149800

Please note

Once you have committed to taking a place on the course fees can not be refunded unless we have to cancel the event.

—————————————–

the secret is out

How much more will you be able to achieve once you’ve discovered THE TEN QUESTIONS ?

Order your copy of Phil Parker’s new book now, and re-design your future today.

Click now www.philparker.org/order.htm to find out more

 

Mr Parker’s scientific opinion on whether medical professionals can assess whether you are “ready” to undertake the scientific Lightning Process:

From the FAQ: Can my doctor assess me for readiness?

If your doctor or health care specialist is trained as a Lightning Process Practitioner then of course they can assess you for readiness to take the programme. If they are not trained in the programme they will not have the requisite skills or knowledge base about this very specialised field to assess you.

A large part of the training for LP practitioners is to train them to appropriately assess potential trainees for their suitability for the process, as it is essential to ensure, as far as is possible, that only those who are ready to get benefits from the training program are enrolled in the training.

 

Mr Parker’s scientific method of resolving CFS and ME, as recounted by a disappointed Lightning Process “trainee”:

Phoenix Rising forum thread

[…]

I had an acute onset and went from a hardworking person to bedbound overnight.

In a desperate attempt to recover I decided to try LP after reading stories of severely affected M.E. patients who had recovered. It all sounded so convincing and after a phone consultation with a LP coach I felt very positive I was doing the right thing. I borrowed the money from my parents, £880.00 as I had long lost my job, and went for it.

There were 3 other m.e. patients at the same course none of these people nor myself recovered. The course was over 3 days from 10am-2pm with a break at lunchtime for tea and biscuits. We were told not to discuss the content of the course with each other during the breaks. We learned the ‘affirmation’ and stood on the floor on paper circles with key words written on them.

Here is the big secret of what we had to say while standing on paper circles –

WHEN YOU FEEL A SYMPTOM
SHOUT- STOP! (stand on the paper STOP)
SAY- I HAVE A CHOICE ( stand on the paper CHOICE)
SAY- YOU CAN CHOOSE THE PIT OR THE LIFE YOU LOVE ( you then stand on the LIFE YOU LOVE circle)
SAY- I CHOOSE THE LIFE I LOVE
SAY- WELL DONE, YOU ARE A FANTASTIC GENIOUS, YOU ARE ON TRACK! I AM WITH YOU EVERY STEP OF THE WAY (you are being your own coach here)
ASK YOURSELF – WHAT DO I WANT?
ANSWER YOURSELF- I WANT ENERGY AND HAPPYNESS LIKE (you say something that means energy etc. to you)
ASK YOURSELF- HOW WILL I GET THIS?
TELL YOURSELF- BY STOPPING EVERY NEGATIVE THOUGHT
EVERY NEGATIVE EMOTION
AND DOING THE LIGHTNING PROCESS.

There are a few more short affirmations and that’s it you are cured of M.E. We all DID leave on the third day full of hope and newly found confidence and told that no-matter how we felt in the future ALWAYS SAY WERE WERE CURED OR THE PROCESS WILL NOT WORK !!!! These coaches are very good at their job but I can assure you they can not cure you of M.E. Think about it PAPER CIRCLES AND AFFIRMATIONS. The four of us all were ‘high’ for a few weeks or months and did indeed do more than usual but sadly all relapsed. 

 

…and if the Lightning Process doesn’t scientifically fix CFS and ME, well there’s plenty more it can sort, according to the sites of some Lightning Process practitioners:

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…

Addictions, adrenal problems, allergies and intolerances, anxiety, balance problems, bloating, blurry vision, brain fog, candida, chemical sensitivity, compulsive behaviours, concentration problems, confusion, constipation, depression, diarrhoea, dizziness, electrical pulsing sensations, excessive sleeping, exhaustion, fatigue, fear, feeling detached or disconnected, fever and chills, flu-like symptoms, frequent coughs and colds, fybromyalgia, hallucinations, head pain or pressure, heartburn, indigestion, insomnia and other sleep disturbances, irritability, irritable bowel syndrome, itching and rashes, itchy eyes, joint pain, light sensitivity, loss of vision, malaise, memory loss, migraines, muscle pain, nausea, noise sensitivity, oedema, panic attacks, painful and/or swollen glands, pins and needles, restless leg syndrome, runny nose, sensitivity to electrical fields/computers/mobiles etc, shaking, shooting pains, skin sensitivity, stomach pain, sun burn sensation, swelling, temperature control problems, thrush, thyroid problems, unrefreshing sleep, vertigo and similar sensations, vomiting, water retention, watering eyes, weakness…

 

Lightning Process practioner, Alastair Gibson* who is part of the research team collaborating in the Dr Esther Crawley NHS Bath/University of Bristol pilot study into the application of Lightning Process in children, due to start recruiting this month, can also provide you with relief and enhancement:

*In June, Mr Gibson was subject to an Advertising Standards Authority ruling in relation to claims made in an advertisement about the efficacy of the Lightning Process for CFS and ME.

Relief from:

Addictions
Anger management
Children’s Anxieties
Sadness
Grief and Loss
Negative Memories
Procrastination
Stomach Problems
Weight Issues Allergies
Stress
Chronic Fatigue Syndrome
Fears and Phobias inc:
Public Speaking
Spiders
Heights
Flying

Relationship Issues

Anxiety and Panic
Compulsions and Obsessions
Guilt
Headaches
Limiting Beliefs
Pain Management
Stuckness

And many more…..

Enhancement of:

Abundance
Emotional Control
Relationships
Self Image
Creativity & Productivity Concentration
Healing
Relaxation
Work and School Performance
And many more…..

Confidence
Life Direction
Self-Esteem
Sports Performance

March 2011 can’t come soon enough.

Landmark agreement extends ASA’s digital remit

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/

———————— 

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

New blood donation policy for ME/CFS patients from 1 November 2010

New blood donation policy for ME/CFS patients from 1 November 2010

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

ME Association

EXCHANGE OF CORRESPONDENCE BETWEEN THE ME ASSOCIATION AND THE CHIEF MEDICAL OFFICER: PROFESSOR DAME SALLY DAVIES

Resulting in the introduction of a new blood donation policy re ME/CFS as from 1 November 2010

August 16 2010

Dear Dame Sally Davies

ME/CFS and blood donation

I wrote to Sir Liam Donaldson on 27 October 2009 following publication of the paper in Science which contained the results of a research study that had found evidence of XMRV infection in people with ME/CFS.

In this letter I referred to The MEA website statement on XMRV, which called for the current UK ban on people with ME/CFS donating blood while being symptomatic to be extended to include anyone who had suffered from the illness in the past but now appeared to be in remission or had recovered. We felt this was necessary given the uncertainty over prevalence, transmission and possible pathogenicity of this infection.

Dr David Harper (Director General of Health Improvement and Protection) replied on 9 November 2009 by stating that this correspondence had been brought to the attention of the Director of the UK Blood Services Joint Professional Advisory Committee and that the situation was to be reviewed by the Standing Advisory Committee on Transfusion Transmitted Infections (SACTTI), who would be producing a risk assessment for the UK Blood Services and the Health Protection Agency. Dr Harper also stated that The MEA concerns had been brought to the attention of  the Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) and the National Expert Panel on New and Emerging Infections (NEPNEI).

Relevant part of the 2009 MEA website statement >>

BLOOD DONATION AND XMRV

In relation to blood donation in the UK, current advice is that people with ME/CFS who have symptoms, or are receiving treatment, should not donate blood. It would seem sensible in the short term, until we know more about transmission and pathogenicity of XMRV, to consider extending this restriction to people who have recovered from ME/CFS. It seems strange that many overseas countries have not followed the UK lead on blood donation and ME/CFS.

The MEA has written to Sir Liam Donaldson, Chief Medical Officer at the Department of Health, regarding the possibility of XMRV being transmitted via human blood products and the implications that this has for blood donation.

The CFIDS Association of America has been issued with guidance from the National Cancer Institute regarding blood donation in the US. The guidance can be read on the CFIDS website.

We now understand, through a letter that is circulating on the internet, that a decision to extend the ban has been made.

Letter in circulation >>

Dear Ms xxxx,

Thank you for your email of 19 July to Andrew Lansley about the xenotropic murine leukemia virus-related virus (XMRV) and chronic fatigue syndrome/myalgic encephalomyelitis (CFS / ME). I have been asked to reply on his behalf.

The issue of XMRV was not specifically raised during the meeting on 20 July with campaigners from Tainted Blood. The National Expert Panel on New and Emerging Infections (NEPNEI) undertook a thorough assessment of the scientific data in June 2010 and concluded that although XMRV can infect humans, there is currently no evidence that it causes disease in humans. NEPNEI’s view is that development of a robust diagnostic tool to detect infection accurately is a priority for further investigation of this infection. Further work is required to investigate which human tissues are susceptible to infection, the epidemiology of infection and whether this infection is of any public health significance.

Both NEPNEI and the Advisory Committee on the Safety of Blood, Tissues and Organs have considered the current evidence and have recommended that no public health action is required at this time. However, the situation will be monitored closely.

In the absence of any infectious cause of CFS, people with this relapsing syndrome are currently excluded from donating blood while they feel unwell, in order to protect their own health. The UK Blood Services will shortly be amending its criteria to exclude such people from blood donation on a lifetime basis, bringing them in line with the practice of not accepting donations from people with other relapsing conditions. Whilst the purpose of this is to protect the donor’s health from any possible harmful effects from donating blood, it will also minimise the likelihood that donations from people who have ever suffered from CFS could enter the blood supply.

I hope this reply is helpful.

Yours sincerely,

Mary Heaton
Customer Service Centre
Department of Health
13 August 2010

We would therefore appreciate some further clarification on this important point and the date when the UK Blood Services will be bringing this extension into effect.

Could I also point out in relation to the opening sentence in the final paragraph of the above letter from Mary Heaton, that whilst it is true that the role for persisting infection in ME/CFS remains uncertain there is very sound evidence, as is referred to in Sir Liam Donaldson’s report into ME/CFS, to show that a variety of infections, predominantly viral, can precipitate this illness. There is also evidence of reactivation of latent viral infection (eg  EBV and HHV-6) in some of these patients.

Finally, you may not be aware that a number of other countries have followed the UK lead in banning blood donations from people with ME/CFS. These countries include Australia, Canada and New Zealand.

However, I find it surprising that no such precautionary action has been announced, at present, by those responsible for blood safety in America.

Yours sincerely

Dr Charles Shepherd

Hon Medical Adviser, ME Association

Member: CMO Working Group on ME/CFS (2002)

Member: MRC Expert Group on ME/CFS Research

ME Association
7 Apollo Office Court
Radclive Road
Gawcott
Bucks MK18 4DF

Website: http://www.meassociation.org.uk

REPLY RECEIVED 27 AUGUST 2010

Dear Dr Shepherd

ME/CFS and Blood Donation

Thank you for your further letter to Professor Dame Sally Davies, Chief Medical Officer (CMO) for the Department of Health, about myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and blood donation. I am responding on her behalf.

As of 1st November 2010, blood donors who report that they have had ME/CFS will be permanently excluded from giving blood in the UK. 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 to donor selection criteria is being made following a recommendation by the UK Blood Services Standing Advisory Committee on the Care and Selection of Donors, and Joint Professional Advisory Committee (JPAC).

Yours sincerely

Clara Swinson
Director of Health Protection
Department of Health

Wellington House, 133-155 Waterloo Road, London SE1 8UG

ENDS

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…”

Media coverage 1: Presence of Murine Leukemia Virus Related Gene Sequences Found in CFS Patients

Media coverage round up 1: Presence of Murine Leukemia Virus Related Gene Sequences Found in CFS Patients  (XMRV PNAS paper)

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

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

Updates will be added to the top of this list:

International media coverage:

 

http://blogs.wsj.com/health/2010/08/25/does-x-the-virus-that-is-mark-the-spot-in-chronic-fatigue-syndrome/

Does X (the Virus, That Is) Mark the Spot in Chronic Fatigue Syndrome?

By Amy Dockser Marcus

When it comes to chronic fatigue syndrome, researchers are starting to ask: What’s the role of the virus known as “X”?

—————–

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

New Scientist  |  25 August 2010

Virus link with chronic fatigue syndrome resurfaces

By Andy Coghlan

“The discovery of mouse virus fragments in cells from people with chronic fatigue syndrome has reinforced earlier claims that they may cause the condition.”

—————–

http://www.smh.com.au/lifestyle/wellbeing/virus-link-to-chronic-fatigue-gives-hope-to-sufferers-seeking-a-cure-20100824-13qgb.html

Syndey Morning Herald
Virus link to chronic fatigue gives hope to sufferers seeking a cure August 25, 2010

—————–

http://www.forums.aboutmecfs.org/content.php?213-Four-Viruses-The-Alter-XMRV-Paper-Arrives
FOUR Viruses? The Alter XMRV Paper Arrives at Phoenix Rising

By Cort Johnson for Phoenix Rising

—————–

Links collated by Jean Harrison via Co-Cure Listserv mailing list:

http://www.cbsnews.com/8301-504763_162-20014504-10391704.html
http://wellness.blogs.time.com/2010/08/24/study-links-chronic-fatigue-to-mouse-virus/
http://www.smh.com.au/lifestyle/wellbeing/virus-link-to-chronic-fatigue-gives-hope-to-sufferers-seeking-a-cure-20100824-13qgb.html
http://www.cnn.com/2010/HEALTH/08/23/chronic.fatigue.virus/?hpt=T2
http://www.psychologytoday.com/blog/complementary-medicine/201008/xmrv-virus-confirmed-in-cfs
http://www.webmd.com/chronic-fatigue-syndrome/news/20100823/virus-linked-to-chronic-fatigue-syndrome
http://www.abc.net.au/science/articles/2010/08/24/2991897.htm
http://www.latimes.com/health/la-sci-fatigue-virus-20100824,0,127566.story
http://www.businessweek.com/lifestyle/content/healthday/642400.html?chan=rss_topStories_ssi_5
http://www.npr.org/blogs/health/2010/08/23/129383111/scientists-find-traces-of-virus-in-chronic-fatigue-patients
http://www.eht-forum.org/news.html?fileId=news100824071904&from=home&id=0
http://blogs.nature.com/news/thegreatbeyond/2010/08/delayed_chronic_fatigue_syndro.html
http://www.nytimes.com/2010/08/24/health/research/24fatigue.html
http://www.mdnews.com/news/hd/2010_35/hd_642389
http://www.hc2d.co.uk/content.php?contentId=15883

—————– 

Wall Street Journal Blogs

http://blogs.wsj.com/health/2010/08/24/pnas-paper-on-virus-chronic-fatigue-syndrome-link-has-its-own-story/

Health Blog
WSJ’s blog on health and the business of health.

By Amy Dockser Marcus

August 24, 2010, 1:55 PM ET.

PNAS Paper on Virus-Chronic Fatigue Syndrome Link Has Its Own Story

The much-awaited PNAS paper published yesterday (and reported in today’s WSJ) about the discovery of a family of retroviruses in patients with chronic fatigue syndrome came with a backstory — its own editorial explaining the publication process.

Here’s why that was necessary. Earlier in the summer, the WSJ reported that the completed paper, by a team of researchers from the NIH, FDA and Harvard Medical School, contradicted findings of a similar study done by CDC researchers and was being held until the discrepancy could be sussed out.

Read on

—————–

US patient organisations

http://www.cfids.org/mlv/caa-response-082310.asp

Another Turn of the Retrovirus Kaleidoscope

By K. Kimberly McCleary  |  23 August 2010

—————–

Podcasts

Listen to the NIH telebriefing on the NIH/FDA study published in The Proceedings of the National Academy of Sciences (PNAS) 23 August 2010:

Part 1: http://www.mediafire.com/?6phy8fyxxj4mhy9

Part 2: http://www.mediafire.com/?40esxfnjflnyzhz  

—————–

Whittemore Peterson Institute Press release in response to paper

http://www.wpinstitute.org/news/docs/WPI_pressrel_082310.pdf

—————–

http://www.businessweek.com/news/2010-08-23/chronic-fatigue-linked-to-mouse-virus-in-u-s-government-study.html

Business Week
Chronic Fatigue Linked to Mouse Virus in U.S. Government Study

—————–

http://www.nytimes.com/2010/08/24/health/research/24fatigue.html?_r=1&hp

New York Times
Study Links Chronic Fatigue to Virus Class

—————–

http://voices.washingtonpost.com/checkup/2010/08/new_evidence_virus_may_cause_c.html?hpid=topnews

Washinton Post
New evidence that virus may cause chronic fatigue

—————–

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

—————–

http://health.msn.com/health-topics/articlepage.aspx?cp-documentid=100262656

More Evidence Virus Plays Role in Chronic Fatigue Syndrome
Condition afflicts a million Americans, but cause, treatments remain elusive
By Jenifer Goodwin HealthDay Reporter

—————–

http://www.the-scientist.com/blog/display/57628/

Q&A: Why I delayed XMRV paper, The Scientist – Magazine of the Life Sciences

—————–

http://online.wsj.com/article/SB10001424052748703846604575447744076968322.html?mod=googlenews_wsj

Wall Street Journal

 

Video

http://www.youtube.com/watch?v=9ZEwQUg7o6I&feature=channel

Dr Judy Mikovits on paper on YouTube

 

Blogs

http://www.cfscentral.com/2010/08/fdanihharvard-xmrv-study-same-thing.html

CFS Central Blog write-up by journalist Mindy Kitei

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

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

Shortlink: http://wp.me/p5foE-31Z

Discussion thread on Phoenix Rising Forums:

http://www.forums.aboutmecfs.org/showthread.php?7072-Dr.-Alter-Paper-embargo-ends-today-at-3-00pm-press-conference-today/

Media

http://health.msn.com/health-topics/articlepage.aspx?cp-documentid=100262656

More Evidence Virus Plays Role in Chronic Fatigue Syndrome
Condition afflicts a million Americans, but cause, treatments remain elusive
By Jenifer Goodwin HealthDay Reporter

The Scientist

Q&A: Why I delayed XMRV paper, The Scientist – Magazine of the Life Sciences

http://www.the-scientist.com/blog/display/57628/

Wall Street Journal

http://online.wsj.com/article/SB10001424052748703846604575447744076968322.html?mod=googlenews_wsj

Dr Judy Mikovitz on paper on YouTube:

http://www.youtube.com/watch?v=9ZEwQUg7o6I&feature=channel 

CFS Central Blog by Mindy Kitei

http://www.cfscentral.com/2010/08/fdanihharvard-xmrv-study-same-thing.html

The just-released study detects variants of the retrovirus XMRV in most CFS patients. In addition, nearly 7 percent of the healthy U.S. controls—all of whom are blood donors—test positive, signaling the contamination of the U.S. blood supply…

…the authors state that their conclusions “clearly support” the October 2009 Science paper linking a retrovirus to the neuroimmune disease Chronic Fatigue Syndrome (CFS), which afflicts 17 million people worldwide…

…Most surprising is that the PNAS study didn’t find XMRV, which stands for Xenotropic Murine Leukemia Virus-Related Virus, in any patients or controls. Instead, the researchers—from the National Institutes of Health (NIH), the FDA and Harvard Medical School—detected novel close cousins to XMRV called MLVs—which stands for Murine Leukemia Viruses—in 86.5 percent of 37 patients and nearly 7 percent of 44 controls.

Read on

 

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

Supporting information:  [PDF  = 4MB]

Download here:

http://www.pnas.org/content/suppl/2010/08/16/1006901107.DCSupplemental

Full paper:

http://www.pnas.org/content/early/2010/08/16/1006901107.full.pdf+html

Or open here, on ME agenda: Full paper

Editorial: Editorial 23.0810

http://www.pnas.org/content/early/2010/08/16/1012027107.full.pdf+html

Commentary: Commentary 23.08.10

http://www.pnas.org/content/early/2010/08/16/1007944107.full.pdf+html  

 

Abstract

http://www.pnas.org/content/early/2010/08/16/1006901107

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

1. Shyh-Ching Lo a , 1 ,
2. Natalia Pripuzova a ,
3. Bingjie Li a ,
4. Anthony L. Komaroff b ,
5. Guo-Chiuan Hung a ,
6. Richard Wang c , and
7. Harvey J. Alter c , 1

+ Author Affiliations

1.
aTissue Microbiology Laboratory, Division of Cellular and Gene Therapies and Division of Human Tissues, Office of Cellular, Tissue and Gene Therapy, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, MD 20892;
2.
bDepartment of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA 02115; and
3.
cDepartment of Transfusion Medicine, The Warren Grant Magnuson Clinical Center, National Institutes of Health, Bethesda, MD 20892

1.

Contributed by Harvey J. Alter, May 25, 2010 (sent for review March 23, 2010)

Abstract

Chronic fatigue syndrome (CFS) is a serious systemic illness of unknown cause. A recent study identified DNA from a xenotropic murine leukemia virus-related virus (XMRV) in peripheral blood mononuclear cells (PBMCs) from 68 of 101 patients (67%) by nested PCR, as compared with 8 of 218 (3.7%) healthy controls. However, four subsequent reports failed to detect any murine leukemia virus (MLV)-related virus gene sequences in blood of CFS patients. We examined 41 PBMC-derived DNA samples from 37 patients meeting accepted diagnostic criteria for CFS and found MLV-like virus gag gene sequences in 32 of 37 (86.5%) compared with only 3 of 44 (6.8%) healthy volunteer blood donors. No evidence of mouse DNA contamination was detected in the PCR assay system or the clinical samples. Seven of 8 gag-positive patients tested again positive in a sample obtained nearly 15 y later. In contrast to the reported findings of near-genetic identity of all XMRVs, we identified a genetically diverse group of MLV-related viruses. The gag and env sequences from CFS patients were more closely related to those of polytropic mouse endogenous retroviruses than to those of XMRVs and were even less closely related to those of ecotropic MLVs. Further studies are needed to determine whether the same strong association with MLV-related viruses is found in other groups of patients with CFS, whether these viruses play a causative role in the development of CFS, and whether they represent a threat to the blood supply.

* xenotropic murine leukemia virus-related virus
* murine leukemia virus-like virus
* viral gag gene sequence
* polytropic
* mouse mitochondria DNA PCR

Footnotes

1To whom correspondence may be addressed. E-mail: shyhching.lo@FDA.hhs.gov  or halter@mail.nih.gov .

Author contributions: S.-C.L., N.P., and B.L. designed research; G.-C.H. designed mouse-specific mitochondria PCR assay; N.P. and B.L. performed research; B.L. and R.W. contributed new reagents/analytic tools; S.-C.L., N.P., G.-C.H., and R.W. analyzed data; and S.-C.L., N.P., A.L.K., and H.J.A. wrote the paper.

The authors declare no conflict of interest.

This article contains supporting information online at www.pnas.org/lookup/suppl/doi:10.1073/pnas.1006901107/-/DCSupplemental .

Newswire

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

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

Download image SILVER SPRING, Md., Aug. 23 /PRNewswire-USNewswire/ — Researchers have found murine leukemia viruses (MLV) related gene sequences in blood samples collected from patients diagnosed with chronic fatigue syndrome (CFS) and some healthy blood donors, according to a study published online today by the scientific journal Proceedings of the National Academy of Sciences (PNAS).

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO  )

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO  )

Investigators from the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research and the National Institutes of Health Clinical Center, in collaboration with a physician scientist at Harvard Medical School, examined blood samples from 37 patients diagnosed with CFS and from 44 healthy blood donors.

MLV is a type of retrovirus known to cause cancer in mice. Several different MLV gene sequences were identified in samples from 32 of the 37 patients with CFS (87 percent) and 3 of the 44 (7 percent) healthy blood donors. Investigators performed DNA sequencing on all positively amplified samples to confirm MLV like gene sequences.

This study supports a previous investigation [Lombardi et al. Science October 23, 2009 326: 585] that showed XMRV, a genetic variant of MLV-like viruses, to be present in the blood of people with CFS. The study demonstrates a strong association between a diagnosis of CFS and the presence of MLV-like virus gene sequences in the blood. The study also showed that MLV-like viral gene sequences were detected in a small fraction of healthy blood donors. Although the statistical association with CFS is strong, this study does NOT prove that these retroviruses are the cause of CFS. Further studies are necessary to determine if XMRV or other MLV-related viruses can cause CFS.

A previous study, published in 2009, reported finding XMRV infections in a high percentage of CFS patients and a small percentage of healthy blood donors. However, several other studies from the United States (including a recent report from the Centers for Disease Control and Prevention), the United Kingdom, and the Netherlands have found no evidence of XMRV or other MLV-like viruses in the blood of people with CFS.

For more information:

FDA MLV Gene Sequence Study – Questions and Answers http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm223232.html

CDC – XMRV Overview

http://www.cdc.gov/ncidod/dhqp/bp_xmrv.html

CDC – XMRV Questions & Answers

http://www.cdc.gov/ncidod/dhqp/bp_xmrv_qa.html

Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov

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SOURCE U.S. Food and Drug Administration

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http://www.nih.gov/news/health/aug2010/cc-23.htm

News Advisory
Scientists to discuss research on XMRV in blood, chronic fatigue syndrome

What:

Telebriefing by experts from the Food and Drug Administration, the National Institutes of Health and the Centers for Disease Control and Prevention to respond to questions about this study. The paper is currently under embargo until Monday, August 23 at 3:00 p.m., by the Proceedings of the National Academy of Sciences.

Who:

Harvey Alter, M.D., Chief, Clinical Studies and Associate Director for Research, Department of Transfusion Medicine, NIH Clinical Center

Shyh-Ching Lo, M.D., Ph.D., Director, Tissue Safety Laboratory Program, Division of Cellular and Gene Therapies and Division of Human Tissues, Office of Cellular, Tissue and Gene Therapies, Food and Drug Administration Food and Drug Administration

Celia Witten, M.D., Ph.D., Director, Office of Cellular, Tissue and Gene Therapies, Food and Drug Administration

Hira Nakhasi, Ph.D., Director, Division of Emerging and Transfusion Transmitted Diseases, Office of Blood Research and Review, Food and Drug Administration

Steve Monroe, Ph.D., Director, Division of High-Consequence Pathogens and Pathology, Centers for Disease Control and Prevention

When:

Monday, August 23, 3:01 p.m. EDT
How: Reporters should call 1-888-677-4212 begin_of_the_skype_highlighting 1-888-677-4212 end_of_the_skype_highlighting and enter passcode 9258555. For those unable to participate, the briefing will be available on replay approximately two hours after briefing concludes. For replay, dial 1-866-373-4990 begin_of_the_skype_highlighting 1-866-373-4990 end_of_the_skype_highlighting and enter passcode 5711.

The NIH Clinical Center (CC) is the clinical research hospital for the National Institutes of Health. Through clinical research, physician-investigators translate laboratory discoveries into better treatments, therapies and interventions to improve the nation’s health. For more information, visit http://clinicalcenter.nih.gov .

The National Institutes of Health (NIH) ” The Nation’s Medical Research Agency” includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov .