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

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

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

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

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

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

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

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

The Anne Diamond Show, Thursday, 11 November 2010:

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

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

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

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

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

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

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

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

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

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

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

Anne Diamond: And yet…?

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

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

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

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

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

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

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

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

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

Anne Diamond: Dr Shepherd?

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

Professor Findley: Agreed…agreed.

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

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

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

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

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

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

Anne Diamond: And Professor Findley?

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

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

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

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

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

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

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

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

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

Related material:

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

2] ASA adjudication against “Withinspiration”, June 2010

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

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

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 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

Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration

Back to top
RELATED LINKS
http://www.fda.gov

 

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 .

ICD-10-CM codings raised at 10 May CFSAC meeting

ICD-10-CM raised at 10 May CFSAC meeting

Shortlink: http://wp.me/p5foE-2SF

A one day public meeting of the US Chronic Fatigue Syndrome Advisory Committee (CFSAC) was held on Monday, 10 May. Minutes of the previous two day meeting and a Videocast of the proceedings of both days (with subtitles) can be accessed here and here.

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). More information here [PDF].

Towards the end of the Spring meeting, Dr Leonard Jason, PhD, raised concerns in response to current proposals for the placement of CFS within the forthcoming US “Clinical Modification”, ICD-10-CM, due to be implemented in October 2013. (See foot of this Dx Revision Watch page for current ICD-10-CM proposals.)

Agenda for this Spring 2010 meeting here

CFSAC Agenda – May 10, 2010
Chronic Fatigue Syndrome Advisory Committee
US Department of Health and Human Services

Meeting was webcast live at http://videocast.nih.gov

Webcast of entire meeting with subtitles is now available to view here

Chronic Fatigue Syndrome Advisory Committee
Monday, May 10, 2010
HHS Office on Women’s Health (OWH)
Total Running Time: 05:47:57

More information here: http://videocast.nih.gov/Summary.asp?File=15884

Presentations, Public Testimonies and Written Testimonies here

Transcripts are being compiled on a dedicated Facebook site here

YouTubes videos here:

New Hillary Johnson blog post – “Sif-Sac, again.” here

Cort Johnson blog

A very different looking federal advisory committee on CFS (CFSAC) discussed its charter, its recommendations, XMRV and the blood supply, what the CDC program will look and more. Asst Secretary of Health Dr. Koh, Annette Whittemore and Kim McCleary spoke. Check out the goings on at the CFSAC meeting in

‘The CFSAC on Itself, XMRV, the CDC and More’ from the Bringing the Heat blog:

Phoenix Rising forum thread here

CFSAC Agenda – May 10, 2010

May 10, 2010

9:00 am
Call to Order
Opening Remarks

Roll Call, Housekeeping
Dr. Christopher Snell
Chair, CFSAC

Dr. Wanda Jones
Designated Federal Official

9:15 am
Welcome Statement from the Assistant Secretary for Health

New Members Statement on CFSAC Interests/Goals
Dr. Howard K. Koh

CFSAC New Members

10:00 am
Remarks from Dr. Elizabeth Unger
Dr. Elizabeth Unger

10:30 am
Blood Safety Update on XMRV
Dr. Jerry Holmberg

11:00 am
Review/Update of past CFSAC recommendations
Committee Members

12:30 pm
Subcommittee Lunch
Subcommittee Members

1:30 pm
Public Comment
(on CFSAC charter)
Public

2:00 pm
Review and Discussion of CFSAC Charter and ByLaws
Committee Members

4:00 pm
Adjourn

US Federal Chronic Fatigue Syndrome Advisory Committee: Minutes of October meeting

The Minutes of the October 2009 meeting of the US Federal Chronic Fatigue Syndrome Advisory Committee (CFSAC) are now available

Shortlink: http://wp.me/p5foE-2QP

CHRONIC FATIGUE SYNDROME ADVISORY COMMITTEE (CFSAC)

http://www.hhs.gov/advcomcfs/

Meeting

Thursday, October 29, 2009
9:00 a.m. to 5:00 p.m.

Friday, October 30, 2009
9:00 a.m. to 4:00 p.m.

Room 800, Hubert H. Humphrey Building
200 Independence Avenue, SW
Washington, DC 20201

The document minutes the proceedings of the Chronic Fatigue Syndrome Advisory Committee (CFSAC) Meeting held on October 29-30, 2009.

Download PDF version: http://tinyurl.com/yjarxlf or open here on ME agenda: CFSAC meeting 29.10.09

HTML version: http://www.hhs.gov/advcomcfs/meetings/minutes/cfsac102909min.html

 

Access a podcast video of entire meeting proceedings for Day One and Day Two at:

Day One: http://videocast.nih.gov/Summary.asp?File=15408

Day Two: http://videocast.nih.gov/Summary.asp?File=15409

[Video transmission has Auto Subtitles. RealPlayer required]

Invest in ME: Letter to UK Secretary of State for Health (Blood donation)

Invest in ME: Letter to UK Secretary of State for Health (Blood donation)

Shortlink: http://wp.me/p5foE-2QL

Update @ 19 March 2010

House of Commons Written Answers: 16 March 2010

Hansard transcript

Chronic Fatigue Syndrome: Research

Mr. Drew: To ask the Secretary of State for Health whether his Department has (a) commissioned and (b) evaluated any research on a relationship between myalgic encephalomyelitis and blood-related disorders. [322011]

Gillian Merron: The Department has, to date, not commissioned or evaluated any research. However, others, such as the Medical Research Council, the Health Protection Agency and the UK Blood Services, are currently considering these issues. I refer the hon. Member to the written answer I gave him on 27 January 2010, Official Report, column 942W.

House of Commons Written Answers: 27 January 2010

Hansard transcript

Chronic Fatigue Syndrome

Mr. Drew: To ask the Secretary of State for Health what recent representations he has received on making myalgic encephalomyelitis a notifiable illness for the purposes of blood donation. [313595]

27 Jan 2010 : Column 942W

Ann Keen: The Department has received 31 representations on making myalgic encephalomyelitis a notifiable illness in the last six months. There have also been a number of representations on this subject received by the Chief Medical Officer.

Mr. Drew: To ask the Secretary of State for Health whether his Department plans to (a) commission and (b) evaluate research on the possible health effects of receiving blood donated by a person with myalgic encephalomyelitis. [313596]

Ann Keen: The Department has no current plans to directly commission research on this issue. However, the Medical research Council has designated myalgic encephalomyelitis/chronic fatigue syndrome a priority research area, and will fund proposals of sufficient quality. The UK Blood Services together with the Health Protection Agency are undertaking a study of the prevalence of a rodent virus recently linked to myalgic encephomyelitis, which will be used to inform a risk assessment.

Mr. Drew: To ask the Secretary of State for Health whether his Department plans to test patients for xenotropic murine leukaemia virus-related illnesses. [313607]

Ann Keen: There are currently no plans to test patients for xenotropic murine leukaemia virus-related virus.

House of Commons Written Answers: 10 March 2010

Hansard transcript

10 Mar 2010 : Column 350W

Chronic Fatigue Syndrome: Blood

Mr. Drew: To ask the Secretary of State for Health for what reasons people with myalgic encephalomyelitis may not donate blood. [321320]

Ann Keen: People with myalgic encephalomyelitis (ME), also known as chronic fatigue syndrome (CFS), are not able to donate blood until they have fully recovered. The reasons for this are: first, blood donors need to be in good health, and people with ME/CFS often experience a range of symptoms which could be made worse by donating blood; and second, as the causes of ME/CFS are not currently fully understood, people with the condition are deferred from donating blood as a precautionary measure to protect the safety of the blood supply for patients.

In response , Invest in ME has written to Rt Hon Andy Burnham MP, Secretary of State for Health:

Invest in ME

Letter to UK Secretary of State for Health

Recently Mrs Ann Keen, Under-Secretary of State for Health, commented that people with Myalgic Encephalomyelitis were not able to donate blood. Invest in ME have written the following letter to the Secretary of State for Health, Mr Andy Burnham.

Myalgic Encephalomyelitis and Blood Donations

Rt Hon Andy Burnham MP

Secretary of State for Health

Department of Health

Richmond House

79 Whitehall

London SW1A 2NS

cc: Mrs Ann Keen MP

14th March 2010

Dear Mr. Burnham,

Recently Mrs Ann Keen (in her capacity as Under-Secretary of State for Health) made the following comments in relation to Myalgic Encephalomyelitis and blood donations –

“People with myalgic encephalomyelitis (ME), also known as chronic fatigue syndrome (CFS), are not able to donate blood until they have fully recovered.

The reasons for this are: first, blood donors need to be in good health, and people with ME/CFS often experience a range of symptoms which could be made worse by donating blood; and second, as the causes of ME/CFS are not currently fully understood, people with the condition are deferred from donating blood as a precautionary measure to protect the safety of the blood supply for patients.”

Mrs Keen’s comments are, we assume, representative of the government and your department.

Firstly it is good that your government recognises that people with ME are in poor health. This implies that all people with ME are therefore in need of proper healthcare provision which treats the disease properly.

Secondly it is good that you and your government recognise, by the implication from your statement, that blood supplies may be compromised by accepting people with ME as donors due to the organic nature of this disease.

Thirdly it follows that an embargo on people with ME donating blood would mean that there is an infectious agent at work which could be passed on via blood.

There follows several questions which lead on from this.

It seems to be crucial to use the most stringent diagnostic criteria available for diagnosing ME (which even NICE acknowledge as being the Canadian Consensus Criteria). Yet your department, NICE and the MRC do not standardise on this internationally accepted standard for diagnosis of ME.

When you state that people with ME are not able to donate blood are you employing the NICE guidelines for defining patients as having ME? If so then why does NICE proscribe serological testing unless there is an indicative history of infection? If no initial indication of infection is present then no further blood tests are performed and a patient may receive a diagnosis of ME based on ongoing fatigue and one other symptom such as sleep disturbance. Why then would those patients be excluded from donating blood?

As your government officially accepts ME as a neurological illness, as described by the World Health Organisation ICD-10 G93.3 code, and as the issue of blood contamination from an infectious agent demands the utmost care and attention, is it not of absolute necessity for your government to demand that a consistent set of up-to-date diagnostic criteria are used as standard by all organisations?

Your department often states that the Medical Research Council is an independent body. Yet as it is apparent that the MRC only funds psychiatric studies which presume that ME is a behavioural illness why does your department refuse to comment on the MRC’s usage of the Oxford criteria for research into ME which expressly excludes people with a neurological illness?

Why does your department not criticise the MRC for funding purely psychiatric research into ME if you fully recognise that ME is a disease of organic and infectious nature? Since when did a psychiatric illness prevent blood donations? Does this not clearly show the MRC policy of research into ME for the last generation to be completely flawed and a waste of precious funding and patients’ lives?

When you state that people with ME are not able to donate until fully recovered please can you define what “fully recovered” means?

Could you also provide a description of how a person with ME is defined as no longer having ME?

What biomedical tests are available to determine that a person with ME is “fully recovered”?

Could you inform of how and when clinicians perform such tests in order to ensure that a person is “fully recovered” from ME?

Bearing in mind the seriousness of a possible contamination of blood supplies from people with ME please could you indicate what measures are in place to ensure that doctors do enforce testing to ensure that people with ME are “fully recovered” and will not therefore donate blood?

If such a test exists then presumably people with ME who are not recovered are entitled to appropriate benefits due to incapacity and/or disability?

As relapses are common with people with ME please could you explain if there is any minimum period which a person with ME needs to be “recovered” to be able to donate blood?

Could you also provide information which your government has on the number of people with ME in this country, the proportion of patients who have had ME for longer than five years and how many people with ME have “fully recovered”?

With regard to your statement that “the causes of ME/CFS are not currently fully understood” is it not inherent on the Chief Medical officer of the UK to attend the 5th Invest in ME International ME/CFS Conference 2010 on 24th May in Westminster, as guest of Invest in ME?

As the foremost experts on ME in the world are presenting at the conference, along with the Whittemore-Peterson Institute – who have recently been involved in the discovery of the XMRV retro-virus which has possibly huge considerations for the blood supply of this country – would it not be sensible for anyone who is involved in healthcare and particularly in the treatment of people with ME to attend this event?

Should not the government of this country also be sending a representative to the conference given that contamination of the blood supply by people with ME may be occurring and that education about the disease needs to be a pre-requisite for anyone involved in healthcare provision for people with ME?

We would request that you provide a full and complete answer to every single one of the questions which we have asked in this letter and we look forward to your reply,

Yours Sincerely,

The Chairman and Trustees of Invest in ME

Invest in ME

Registered UK Charity Nr. 1114035

PO BOX 561, Eastleigh SO50 0GQ

Support ME Awareness – Invest in ME

Related material:

Donations and transfusions: Safety of the UK blood supply  13 February 2010

FOIs and questions to Imperial College, London re XMRV testing

FOIs and questions to Imperial College, London re XMRV testing

Shortlink: http://wp.me/p5foE-2NL

Update @ 21 February

The following request for information has also been submitted:

To: Imperial College London, Freedom of Information Office

Re: XMRV testing available via ICL Molecular Diagnostics Unit (MDU)

21 February 2010

I would appreciate acknowledgement of this request for information.

A revised notice on the website for the MDU states:

“The MDU offers XMRV testing for research purposes only. If you are a researcher who is interested in XMRV testing, please contact the unit with an outline of your requirements.

“There has been some confusion around the availability of the XMRV test, for which we apologise. We would like to clarify that it is only available as part of an ethically approved research project. We emphasise that our laboratory does not deal directly with patients and we are not advising people who are concerned that they might have CFS, or who have been diagnosed with CFS, to request this test.”

On 6 February, The ME Association had published a notice on its website stating that it had been informed that an earlier announcement about XMRV testing on the MDU website:

“did not apply to people with ME/CFS, or suspected ME/CFS”

and that the test related only to:

“the availability of the Imperial College XMRV test to referring doctors who are dealing with cases of prostate cancer. A full clarification will appear on the Imperial College website on Monday.”

Although it has since been clarified by ICL that the XMRV testing being made available through the MDU is for researchers only, confusion persists over which diseases/conditions this test is being offered for.

I request the following information under the FOI Act:

1] For what diseases/conditions/study domains is the XMRV test being made available to researchers?

Sincerely,

etc.

 

The following requests for information under the Freedom of Information Act have been submitted to Imperial College, London and are published with permission. Information has also been requested direct from the Molecular Diagnostic Unit, Imperial College London. This issue will be updated when requests have been fulfilled.

Submitted by: Kim LeMoon
Date: 08 February 2010
Receipted: 09 February 2010

To: Imperial College London Freedom of Information Officer

Re: Request for information under FOIA in respect of all ongoing research projects or scheduled research projects relating to XMRV (Xenotropic murine leukemia virus-related virus) detection via blood samples, tissue samples or any other methods of detection

I should be pleased if receipt of this request for information could be acknowledged, together with the date by which a response will be provided.

I request the following information under the Act:

Project Supervisors:

Project title:

Laboratory supervisor:

Clinical supervisor:

1] Any Identification or Reference code assigned to Project

2] Project’s Public Title; Project’s Scientific Title

3] Study hypothesis/rationale (where applicable)

4] Ethics approval and any reference numbers attached to this approval

5] Study design

6] Countries of recruitment; Centres of recruitment; Other methods of recruitment

* Through what means will prospective participants be recruited?

7] For what diseases/conditions/study domains are patient samples to be collected?

* Through what means will control samples be assembled?

8] Participants – inclusion criteria

9] Participants – exclusion criteria

10] Target number of participants

11] Patient information material: please provide copies of any patient information material

12] Anticipated start date

13] Anticipated project completion date

14] Sources of funding

15] Sponsor details

Re: Addendum To Previous Request for information under FOIA in respect of all ongoing research projects or scheduled research projects relating to XMRV (Xenotropic murine leukemia virus-related virus) detection via blood samples, tissue samples or any other methods of detection

I should be pleased if this addendum is processed together with my first request that was sent earlier today 8 Feb 2010.

Please acknowledge receipt of both requests along with a Reference Number, and the date by which a response will be provided.

In addition to the earlier request that was made today, I request the following information under the Act:

1] Principal Investigator(s):

2] Names of Project Collaborator(s):

3] Names of Collaborating Institution(s):

From 27 Jan 2010 until 8 Feb 2010, XMRV Detection Testing was offered for £200 by the Molecular Diagnostic Unit via the Imperial College London website. On 8 Feb 2010, the information was removed from the website and replaced with this notification:

We wish to apologise for any confusion concerning the availability of this test and would like to clarify that it is only available as part of an ethically approved research project. We emphasis that our laboratory does not deal directly with patients and we are not advising people who are concerned that they might have CFS, or who have been diagnosed with CFS, to request this test.

Please provide answers to the following questions:

4] Why was the Molecular Diagnostic Unit charging £200 if the XMRV Diagnostic Testing is to be carried out as part of an ethically approved research study?

5] Why was the XMRV Diagnosic Test being advertised to referring medical practitioners (GPs or hospital doctors) if the testing is being carried out as part of an ethically approved research study?

6] If the XMVR Diagnostic Test was not being offered for people who are concerned that they might have CFS, or who have been diagnosed with CFS, what patient population was the test intended for?

Submitted by: Richard Dagg
Date: 09 February 2010
Receipted: 10 February 2010

To: Imperial College London
Freedom of Information Officer

Re: Request for information under FOIA in respect of Molecular Diagnostic Unit XMRV Test

Please acknowledge receipt of this request along with a Reference Number, and the date by which a response will be provided.

From 27 Jan 2010 until 8 Feb 2010, XMRV Detection Testing was offered for £200 by the Molecular Diagnostic Unit via the Imperial College London website.

Please provide information regarding the exact testing methods employed in the test offered including, but not limited to the following:

1) blood sample volumes and processing
2) does the test use a molecular plasmid control in water or a positive blood sample
3) primer sequences and amplification protocol used

From Stephen Ralph via Co-Cure

09 February 10

[CO-CURE] ACT: Questions for Dr Steve Kaye and Professor Simon Wessely at Imperial College

It was recently announced that the test offered on the Imperial College website for XMRV in relation to CFS/ME and prostate cancer was now being withdrawn with immediate effect.

Imperial’s excuse for withdrawing the XMRV test from their website for “CFS/ME” and prostate cancer was because it wasn’t meant for patients and that it was only meant for “an ethically approved research project.”

Well, if this was the case then where does that leave all the other tests it offers on its website?

http://tinyurl.com/ylpmnq3

STI’s for £40 (each),

HCV genotyping for £100,

HBV for Genotypic Drug Resistance costing £100,

HTLV (costs covered by the NHS) and

HIV-1 (costs covered by the NHS)

Question 1 – Was this test that Imperial was offering (on the same basis as all the other test above) the same test used for the recent Imperial/PLoS One study?

Question 2 – Was the test different and if so – how was it different?

Question 3 – As all the other tests (shown above) are still available under the same framework then regardless of whether or not such tests are only available via requests from GP’s or Specialists – opposed to being offered direct to patients; why was the XMRV test removed?

Question 4 – If the answer to Question 2 was “No” and it wasn’t different then where does this leave the credibility of the PLoS One/Imperial study?

Question 5 – Was the Imperial test removed from the website because it was inherently unreliable? (Go back to Question 4)

Readers wanting answers to these question need to contact Dr Steve Kaye who was cited on the Imperial website as being the contact for the XMRV test (now withdrawn)..

http://wwwfom.sk.med.ic.ac.uk/resources/543939B5-003D-4709-B6EC-238FC0D5502F

Email: steve.kaye@imperial.ac.uk
Tel: 020 759 43917 (direct)

FAO Dr Steve Kaye
Molecular Diagnostic Unit,
Imperial College London
4th Floor, Medical School Building
St. Mary’s Hospital
Norfolk Place
London W2 1PG

I have asked Dr Kaye these questions and so far I have not received a reply.

Sincerely,

Stephen.

http://www.meactionuk.org.uk

Donations and transfusions: Safety of the UK blood supply

Donations and transfusions: Safety of the UK blood supply

Shortlink: http://wp.me/p5foE-2ML

Update:  Additional information from US organisation AABB (formerly known as the American Association of Blood Banks)

http://www.aabb.org/Content/About_Blood/Emerging_Infectious_Disease_Agents

Emerging Infectious Disease Agents and their Potential Threat to Transfusion Safety

Xenotropic Murine Leukemia Virus-related Virus (XMRV) January 2010 (PDF)

http://www.aabb.org/documents/About_Blood/EID/XMRV_factsheet_fromWB_010510.pdf

See also Media Statement: Issued 17 February 2010

http://www.aabb.org/Content/News_and_Media/Statements/statement021710.htm

 

1] Advisory Committee on the Virological Safety of Blood

Minutes Meeting 25 February 1991

CHRONIC FATIGUE SYNDROME (ME) AND BLOOD TRANSFUSION (ACVSB 9/10) (Minute 31, 32)

Source: Website ScotBlood: http://www.scotblood.co.uk/subfreedom.asp?scatid=7

Specific document URL: http://www.scotblood.co.uk/site/pubdocs/19910225_acvsb_9th_meeting_7.pdf

Note: the copy of the Minutes currently uploaded to the Freedom of Information documents webpage of ScotBlood website is incomplete. When originally placed on line, historically, following an FOI request for a number of documents, the document had been scanned to PDF odd numbered pages only. A recent request has been made to ScotBlood for a copy of the complete document and this has now been fulfilled. There are a number of additional documents on the ScotBlood site associated with this meeting – appendices and other material, but not the meeting Agenda.

Senior Public Affairs Officer, Scottish National Blood Transfusion Service confirmed on 5 March 2010 that copies of the ACVSB minutes held by SNBTS were released in response to a Freedom Of Information request in March 2006; that they would have been placed on the SNBTS website shortly after the FOI response was issued.

The full document, which is not yet available on the ScotBlood website, can be opened here in PDF:

25.02.91 ACVSB 9th Meeting Minutes (Full doc)

PDF of Page 10 only: Minutes Meeting 25 February 1991: ME_Chronic_Fatigue_Syndrome_ACVSB_Vol_9

The PDF of Page 10, only, kindly provided by Tainted Blood Committee: http://www.taintedblood.info/index.php

Word document: Transcript, Page 10, Minute 31 and 32: Transcript Page 10 Minutes 9th Meeting ACVSB 25.02.91

Transcript Page 10, Minutes: Meeting of the ACVSB 25 February 1991

CHRONIC FATIGUE SYNDROME (ME) AND BLOOD TRANSFUSION (ACVSB 9/10)

31 Dr Pickles said that it had been suggested that the Department should introduce routine testing of blood donations for ME to prevent transmission of the infection(s) responsible for this disorder. It was feasible that infection may be transmitted to transfusion recipients, a small proportion of whom might develop chronic symptoms, themselves.

32 It was agreed that the evidence available did not support the introduction of a test. The Committee, however, would continue to watch any developments with interest.

ANY OTHER BUSINESS

[…]

2] Letter to Secretary of State for Health from Mr Mark XXXXXXX, Tainted Blood Committee, 6 January 2010

[A PDF of the original letter of request for information is held on file]

Open Word document: Mr Burnham 06.01.10

[Sender address redacted]

6th January 2010

Secretary of State for Health
Department of Health
Richmond House
79 Whitehall
London
SW1A 2NS

Dear Mr Burnham.

My name is XXXXXXXXXX, one of the now 300 surviving haemophiliacs from the contaminated blood disaster of the late 70’s, 80’s and 90’s. I was infected with HIV, Hepatitis B and C, CMV, Bovine TB and await the validation of the current vCJD test used by the Nation Blood transfusion service. This will reveal whether the factor 8 treatment taken from someone who later went of to die from vCJD I received, has infected me with yet another deadly contaminant. As you will understand I live a life of fear, pain, exclusion and most of all a sense of complete failure by those who are meant to help. Even now after of the many years of campaigning your department continues to add to the suffering caused by the NHS treatments and products I have received. I therefore ask for your assistance in getting this scandal rectified once and for all and the safety of the blood supply in this country secured.

I recently spoke to an infected haemophiliac friend of mine, who asked if I had any information regarding Retro-viruses and Hepatitis G. It appears he was told both, Retro-viruses and HGV or the Delta virus as it otherwise known is easily transmitted via blood or blood products and haemophiliacs are at high risk from this. He went on to tell me that because I am infected with HIV and HCV, Hepatitis G is commonly found and this accelerates the rate of progression of the other viruses and I should therefore speak to my doctor regarding my infection status.

After, speaking to the Haemophilia Society, who could offer very little advice on this subject? I wrote to my haemophilia centre director, asking him for any information he could give me. In his reply he told me, “We do not have current plans to test for the viruses I mentioned”. I have also written to Dr N Connor at the HPA, on the 16th of November 2009 but have still not received a reply.

Could you possibly give me your understanding or any information on what the Department of Health know and what they are doing about these retro-viruses and Hepatitis G here in Britain? Although, the internet is a very useful tool, the huge amount of data I have found so far, shows that haemophiliacs with HGV have been studied for many years across the globe. On the Caribbean island of Martinique, routine blood samples are taken to monitor their viral infections, with a cohort study that has been ongoing since 1992. Also in Japan numerous papers have been released to the medical profession on this subject.

It has also been bought to my attention that sufferers of the disorder ME or “Yuppy flu” have been lobbying MP’s for some considerable time, along with talks at the APPG, Chaired by Dr Des Turner MP, to try and protect the blood supply have failed.

The medical data proving the retro virus XMRV found in those suffering from ME can be easily transfused into others through blood and blood products, has once again been ignored and they are still permitted to donate blood. If this is true, then something that speeds up my past viral infections along with further pathogens still allowed to be pumped into innocent victims, surely is something health officials here in Britain are fully aware of. The procedure for being tested for this and other retro viruses is also widely published via the internet.

I look forward to your reply and your comments.

Best wishes

XXXXXXXXXX

Open Word document: Response Department of Health 26.01.10

[A PDF of the original response is held on file]

3] Response from Customer Service Centre, Department of Health, 26 January 2010

Our ref: TO00000471780

Department of Health

Richmond House
79 Whitehall
London
SW1A 2NS

Tel: 020 7210 4850

26 January 2010

[Recipient address redacted]

Dear XXXXXXXXXX

Thank you for your letter of 6 January to Andy Burnham about contaminated blood. I have been asked to reply on his behalf.

The Government is deeply sorry that patients were infected through treatment with contaminated blood products. I can assure you that, since the mid-80s, with the development of new testing and processing technologies, the measures now in place to assure the safety and quality of human blood and blood components, and blood products manufactured from them, have developed significantly.

I note your concerns about the possible presence of retroviruses, including the Hepatitis G virus (HGV). There is no evidence of any disease associated with this virus, which is now usually referred to as the GB Virus C (GBV-C), and which appears not to cause any hepatitis at all.

However, with reference to Factor VIII treatment, coagulation products are all subject to heat treatment, which has been demonstrated to be effective against viruses such as HBV, HCV and HIV. There is every reason to believe that other retroviruses, and other hepatitis viruses, will be similarly inactivated.

Retroviruses, of which HIV is the most talked about for human infection, and GBV-C, are enveloped viruses. The viral removal/destruction processes used by international fractionators are validated to remove enveloped viruses during the manufacture of plasma-derived products.

Any new findings about emerging viruses, such as the xenotropic murine leukemia virus-related virus (XMRV), which may have implications for the safety of the UK’s blood supply, are assessed through the Standing Advisory Committee on Transfusion Transmitted Infections (SACTTI) and then consideration is given by the Joint United Kingdom Blood Transfusion Services and National Institute of Biological Standards and Control Professional Advisory Committee (JPAC) and the Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO).

It is worth noting that the recent paper Failure to Detect the Novel Retrovirus XMRV in Chromic Fatigue Syndrome, published on 6 January 2010, in the online journal PLoS ONE, stated that there was no evidence of infection in ME sufferers. This article can be accessed on the website http://www.plosone.org by clicking on the link ‘Browse all recently published articles’ then clicking on the link ‘Jan 06’ [sic] and scrolling down. The UK group reported the findings of a study in which DNA from the blood of 186 patients with chronic fatigue syndrome (CFS) was tested for XMRV. All blood sample were negative. Based on the molecular data they received, the authors conclude that they: do not share the conviction that XMRV may be a contributory factor in the pathogenesis of CFS, at least in the UK.

I hope this reply reassures you about the safety of the UK’s blood supplies.

Yours sincerely,

Mary Heaton [Signed]
Customer Service Centre

4] Written questions

Source: UK House of Commons
Date: 27 January 2010
URL:
http://www.publications.parliament.uk/pa/cm200910/cmhansrd/cm100127/text/100127w0022.htm
Ref: http://www.me-net.combidom.com/meweb/web1.4.htm#westminster

[Written Questions]

Chronic Fatigue Syndrome

Mr. Drew

To ask the Secretary of State for Health what recent representations he has received on making myalgic encephalomyelitis a notifiable illness for the purposes of blood donation. [313595]

Ann Keen

The Department has received 31 representations on making myalgic encephalomyelitis a notifiable illness in the last six months. There have also been a number of representations on this subject received by the Chief Medical Officer.

Mr. Drew

To ask the Secretary of State for Health whether his Department plans to (a) commission and (b) evaluate research on the possible health effects of receiving blood donated by a person with myalgic encephalomyelitis. [313596]

Ann Keen

The Department has no current plans to directly commission research on this issue. However, the Medical research Council has designated myalgic encephalomyelitis/chronic fatigue syndrome a priority research area, and will fund  proposals of sufficient quality. The UK Blood Services together with the Health Protection Agency are undertaking a study of the prevalence of a rodent virus recently linked to myalgic encephomyelitis, which will be used to inform a risk assessment.

Mr. Drew

To ask the Secretary of State for Health whether his Department plans to test patients for xenotropic murine leukaemia virus-related illnesses. [313607]

Ann Keen

There are currently no plans to test patients for xenotropic murine leukaemia virus-related virus.

(c) 2010 Parliamentary copyright

 

Additional material:

5] BBC News: 3 February 2010  Video report http://news.bbc.co.uk/1/hi/england/8496533.stm

Haemophiliacs lobby for support  Haemophiliacs who contracted HIV and Hepatitis C after being given contaminated blood lobby MPs to back a Bill to give them financial support. The Bill has its second reading on Friday. 

READ MORE: Protest anger at blood ‘scandal’  
READ MORE: Contaminated blood inquiry opens

 

6] Third Reading

Contaminated Blood (Support for Infected and Bereaved Persons) Bill [HL]
House of Lords debates, 21 January 2010, 4:43 pm
Clause 2 : Blood donations 
http://www.theyworkforyou.com/lords/?id=2010-01-21a.1180.2

Amendment 1

Moved by Baroness Masham of Ilton

1: Clause 2, page 2, line 22, at end insert “the blood supply is made safe through the implementation of prion filtration and that”…

 

7] Lord Archer Report [Word doc] 

Independent Public Inquiry Report On NHS Supplied Contaminated Blood and Blood Products

Published: 23 February 2009  www.archercbbp.com

“To investigate the circumstances surrounding the supply to patients of contaminated NHS blood and blood products; its consequences for the haemophilia community and others afflicted; and suggest further steps to address both their problems and needs and those of bereaved families”.

 

8] http://www.slowlyslowlycatchymonkey.com/4.html

The Shredding Fiasco (1989-1992)
“Papers were not adequately archived and were unfortunately destroyed in error.”
           Caroline Flint, 23 May, 2006

 

9] Hansard 7 June 2007

http://www.parliament.the-stationery-office.co.uk/pa/cm200607/cmhansrd/cm070607/text/70607w0004.htm

Health
Blood: Contamination

Jenny Willott: To ask the Secretary of State for Health (1) if her Department will release the audit certificates for files containing documents mistakenly destroyed by the Department in the 1990s and which were the subject of an Internal Audit Report in April 2000 before the end of the inquiry chaired by Lord Archer into contaminated blood and blood products; and if she will make a statement; [141006]

7 Jun 2007 : Column 647W

(2) what records her Department holds on the work of the Advisory Committee on the Virological Safety of Blood relating to the years 1989 to 1993; and if she will make a statement. [141032]

Caroline Flint: The Department holds seven files on the work of the Advisory Committee on the Virological Safety of Blood for the period 1989-93.

I regret that some volumes were destroyed in the 1990s, and this was the subject of an internal review and report in 2000 which is now in the public domain. The internal audit report clearly sets out the sequence of events which led to the destruction of files.

Jenny Willott: To ask the Secretary of State for Health if she will release the documents returned to the Department by solicitors in a previous litigation against the Department as referred to in the Review of Documentation relating to the Safety of Blood Products 1970 to 1985 to the independent public inquiry chaired by Lord Archer into contaminated blood and blood products; and if she will make a statement. [141029]

Caroline Flint: The papers returned to the Department by solicitors have already been released in line with the Freedom of Information Act, and are in the public domain.

The Department has given an undertaking to release all the papers held on the issue of blood safety between 1970-85. The papers returned from solicitors and the references to the report “Self Sufficiency in Blood Products in England and Wales” will consequently be sent to the independent inquiry.

Jenny Willott: To ask the Secretary of State for Health (1) what plans her Department has to submit (a) written evidence and (b) oral evidence from (i) Ministers, (ii) civil servants and (iii) NHS staff to the independent public inquiry chaired by Lord Archer into contaminated blood and blood products; and if she will make a statement; [141030]

(2) whether her Department has been asked to provide (a) Ministers, (b) civil servants and (c) NHS staff as witnesses for oral evidence in the independent public inquiry chaired by Lord Archer into contaminated blood and blood products; and if she will make a statement. [141031]

7 Jun 2007 : Column 648W

Caroline Flint: Lord Archer of Sandwell wrote to the Secretary of State for Health in February to invite the Department to give evidence at the independent inquiry.

Officials met with members of the inquiry team on 25 April 2007 to discuss what information the Department may be able to provide to the inquiry. We have made available a recently completed document on the “Review of Documentation Relating to the Safety of Blood Products 1970-1985 (Non A Non B Hepatitis)”, and the supporting references. Copies of the document are available in the Library.

Officials continue to liaise with the secretary to the inquiry team.

 

10] ME Association  28 November 2009

November 27 update on XMRV and ME/CFS XMRV and ME/CFS? What do we know so far? And what don’t we know? (version 4)

Version 4 of the MEA position statement on XMRV clarifies some of the points and queries raised in the previous three summaries. Version 4 also updates the situation on XMRV research in the UK, testing for XMRV, and refers to our correspondence with the Chief Medical Officer regarding blood supplies and blood donation.

This summary is intended to be a balanced account of the current situation. It therefore not only raises questions but is also very cautious when it comes to drawing any firm conclusions about the role of XMRV in ME/CFS as either a diagnostic marker, causative agent, or abnormality that requires active treatment with antiviral medication.

[…]

VIRAL TRANSMISSION

We know that some people with ME/CFS are now very concerned about the possibility of transmission of XMRV through what are termed body fluids (ie blood, saliva, semen). However, until we know more about what this virus does in the body it would be premature to start arriving at firm conclusions and recommending all kinds of restrictions to normal daily living.

Remember: we still do not know for certain whether this is a disease-causing virus in humans and whether it plays a role in causing or maintaining ME/CFS.

And if this virus was behaving as an ‘ME virus’ in the way that HIV, another retrovirus, causes and transmits HIV infection, often leading to AIDS, there would be a significant number of sexual partners of people with ME/CFS developing ME/CFS. But this is clearly not the case.

One simple way of obtaining some early clues about viral transmission of XMRV would be to test for the presence of the virus in healthy partners and offspring of people who have the infection and comparing the findings to a control group of people that have no such link.

PRESENCE OF XMRV IN THE HEALTHY POPULATION

If this virus is also present in up to 4% of the normal healthy population here in the UK (ie around 2.4 million, or ten times the number of people who have ME/CFS), as appears to be the case in America, and it does play a significant role in diseases such as ME/CFS and prostate cancer, there will be widespread and very serious implications for public health, blood donation etc. This could also include vaccination against the virus and treating people who are XMRV positive.

These are complex decisions which can only be made in the light of further research studies. And this will take time.

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. A copy of this letter can be read here. (Ed: copy at [11])

The reply from the CMO, which outlines the various expert bodies to whom attention has been drawn and advice is being sought, can be found here. (Ed: copy at [12])

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 here (Ed: copy at [13])

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11] ME Association 

Archived news XMRV and ME/CFS: The MEA writes to the Chief Medical Officer

Dear Sir Liam

Implications of research findings concerning XMRV and ME/CFS

I assume you are aware of the new research findings from America, published in Scienceon 8 October 2009,which relate to the retrovirus known as XMRV (xenotropic murine leukaemia virus) and ME/CFS.

The ME Association has produced some information which summarises the research findings and the practical implications they may have in relation to disease management. Our position statement acknowledges that many uncertainties remain and that further research studies are needed before anyone can conclude that this virus plays a significant role in either the cause, assessment or management of ME/CFS. We are in contact with several research groups (UK and overseas) who have experience in retroviral research and it is encouraging to note that there is a strong desire in the research community to take this forward as a matter of urgency. I can supply further information if necessary. The ME Association summary, which also contains a link to the XMRV research paper, can be found on our website.

I would also like to draw your attention to two statements that have been issued by the National Cancer Institute in America in relation to XMRV. The first statement, which refers to the research findings, can be found here. The second statement, which refers to transmission and blood donation, can be found here. The NCI interim guidelines relating to blood donation in the second statement (>> point 2) are very similar to those contained in the MEA summary, and the issue of XMRV transmission is something that obviously needs to be brought to the attention of the National Blood Service and Health Protection Agency if not already done so. A clear statement from the National Blood Service in relation to blood donation from people with ME/CFS would obviously be very helpful to people at this time.

If the Department of Health, or the National Blood Service, would like to add anything to the MEA information, which is being updated at regular intervals, we would be happy to include it.

Yours sincerely

Dr Charles Shepherd
Honorary Medical Adviser, The ME Association
7 Apollo Office Court
Radclive Road
Gawcott
Bucks MK18 4DF

Formerly a member of the CMO Working Group on ME/CFS

Copies:
Dr Des Turner MP – Chair of the All Party Parliamentary Group on ME
Countess of Mar – Chair of Forward ME Group
Dr Jonathan Stoye – National Institute for Medical Research
Professor Stephen Holgate – Chair of MRC Expert Group on ME/CFS Research
Professor Tony Pinching – Peninsular Medical School

 

12] ME Association  13 November 2009

XMRV – comments from the Chief Medical Officer on blood donation and blood transfusion services

The ME Association wrote to Sir Liam Donaldson, Chief Medical Officer at the Department of Health, in October in relation to XMRV research – in particular the situation regarding blood donation and blood transfusion services here in the UK.

Click here to read a copy of this letter.

We have now received a reply from the CMO, with the following key points:

The Standing Advisory Committee on Transfusion Transmitted Infections (SACTTI), part of UK Blood Services, will be producing a risk assessment for this virus.

The current advice from UK Blood Services in relation to ME/CFS has been further clarified: Individuals suffering from ME/CFS are deferred from blood donation until their condition has resolved and they are feeling completely well.

The research has also been drawn to the attention of the secretariats for the Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) and the National Expert Panel on New and Emerging Infections (NEPNEI), who will continue to monitor developments in conjunction with UK Blood Services and the Health Protection Agency.

A copy of the MEA letter and information on XMRV has also been passed to the Professional Director of the UK Blood Services Joint Professional Advisory Committee, along with all the UK virology and retrovirology experts who were copied into our original correspondence.

The MEA would like to thank everyone who has been in contact with information regarding blood donation by people with ME/CFS in other countries. We are keen to continue building up this database and any further help here would be much appreciated. It appears that there are very few countries who currently take the same position, or a similar position on blood donation, to that in the UK.

XMRV research will obviously feature during discussions that will be taking place at the Medical Research Council’s Expert Group Workshop on ME/CFS next week in Oxfordshire.

Dr Charles Shepherd
Hon Medical Adviser, ME Association
Member of the MRC Expert Group

 

13] CFIDS Association of America  23 October 2009

Interim XMRV Guidelines from National Cancer Institute

John E. Niederhuber, M.D., Director, National Cancer Institute
23 October, 2009

Interim XMRV Guidelines from National Cancer Institute

(Following the Oct. 8 publication by Lombardi et al in Science linking CFS and xenotropic murine-related retrovirus (XMRV), the CFIDS Association of America requested guidance from the National Cancer Institute about XMRV for persons diagnosed with CFS, their loved ones and the general public. The following are interim guidelines excerpted from a letter received from NCI director Dr. John E. Niederhuber.)

Interim XMRV Guidelines from National Cancer Institute

We at the National Cancer Institute (NCI) have great interest in these initial research findings. At present, we agree that a critical issue to be addressed is whether the exciting recent results obtained using samples from the Nevada cohort can be reproduced in additional cohorts of CFS-afflicted individuals. The NCI is striving to develop tools so that the general prevalence of XMRV in the population can be ascertained, and the association of XMRV with disease can be examined.

In the meantime, it is very important to reiterate what we do not know at this point, specifically:

1  We do not know whether XMRV is a causative agent for CFS, prostate cancer, or any other disease. Even if a causal association can be established, it may be only one of many causes, and there may be other factors, genetic or environmental, that determine the outcome of infection. At the moment, there is no evidence of CFS transmission between family members, even though XMRV appears to be an infectious agent. Thus, it is unclear whether XMRV alone underlies CFS.

2  We do not know how XMRV is transmitted from individual to individual. Recent suggestions of sexual or salivary transmission are not based on direct evidence, and conclusions regarding transmission are not credible at this point. Given the frequent isolation of virus from white blood cells, blood-borne transmission is a real possibility, and, while we are not in a position to establish firm guidelines, prudence would dictate that potentially infected individuals refrain from blood donation at this time.

3  We do not know how many apparently healthy individuals are infected, and what the distribution of infection is within the U.S. and in the worldwide population. The National Cancer Institute is involved in coordinating a global effort to study these issues.

It is very important to keep in mind that there is no evidence for a new increasing or spreading XMRV infection. Further, no credible evidence exists for direct transmission of either CFS or prostate cancer.

John E. Niederhuber, M.D.
Director, National Cancer Institute
U.S. National Institutes of Health
Department of Health and Human Services
October 23, 2009