Donations and transfusions: Safety of the UK blood supply
Update: Additional information from US organisation AABB (formerly known as the American Association of Blood Banks)
Emerging Infectious Disease Agents and their Potential Threat to Transfusion Safety
Xenotropic Murine Leukemia Virus-related Virus (XMRV) January 2010 (PDF)
See also Media Statement: Issued 17 February 2010
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:
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
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.
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
Tel: 020 7210 4850
26 January 2010
[Recipient address redacted]
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.
Mary Heaton [Signed]
Customer Service Centre
4] Written questions
Source: UK House of Commons
Date: 27 January 2010
Chronic Fatigue Syndrome
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. 
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.
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. 
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.
To ask the Secretary of State for Health whether his Department plans to test patients for xenotropic murine leukaemia virus-related illnesses. 
There are currently no plans to test patients for xenotropic murine leukaemia virus-related virus.
(c) 2010 Parliamentary copyright
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.
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
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”.
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
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; 
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. 
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. 
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; 
(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. 
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.
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 )
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 )
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 )
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.
Dr Charles Shepherd
Honorary Medical Adviser, The ME Association
7 Apollo Office Court
Bucks MK18 4DF
Formerly a member of the CMO Working Group on ME/CFS
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