Letter from Christopher Bird on Behalf of the Department of Health
Posted Dec 21 2010 10:54am
Dear Ms Pring,
Thank you for your further recent emails to Andrew Lansley about xenotropic leukaemia virus-related virus (XMRV) and chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). I have been asked to reply on Mr Lansley’s behalf.
The detection of XMRV infection in humans is a rapidly moving field in medicine. The stark differences in prevalence of apparent infection seen globally in what amount to similar studies do present issues that will need further investigation, but are unlikely to be solely the result of different methodologies. Officials are assured that detection of the XMRV genome based on amplification of the number of copies present (PCR) is widely regarded as the best and most sensitive method available for this purpose.
The methods used to seek evidence of XMRV infection in English blood donors, which employed PCR and included appropriate controls, are able to detect the XMRV genome with high sensitivity and specificity. No evidence of the XMRV genome was found in any donor in the study conducted by NHS Blood and Transplant (NHSBT) and the Health Protection Agency (HPA). The completed study of 540 donors is a prelude to further extensive studies, which NHSBT is funding. Further research to develop and apply a test for an antibody to XMRV is being considered currently by the HPA and NHSBT.
Whilst XMRV is under continuing review by the UK Blood Services Joint Professional Advisory Committee, the international published evidence does not currently support concerns about a risk to the safety of the blood supply. There is at present no accepted causal role for XMRV in human disease.
As the Department set out in its first response, the National Expert Panel for New and Emerging Infections has considered all available evidence about XMRV and reported that no public health action is required at this time. The Advisory Committee on the Safety of Blood, Tissues and Organs, on the basis of current evidence, does not recommend further measures at present. Both groups will continue to monitor the situation.
With regard to research into CFS/ME, the Department of Heath funds research for health policy development, clinical and applied health research in the NHS, and covers the NHS costs incurred in supporting research funded by other bodies such as the Research Councils. As far as current UK research into CFS/ME is concerned, the bulk of the publicly funded work is being undertaken with funding from the Medical Research Council (MRC).
Neither the Department's National Institute for Health Research nor the MRC usually ring fence funds for expenditure on particular topics: research proposals in all areas compete for the funding available. Both organisations welcome applications for support for research into any aspect of human health and these are subject to peer review and The MRC is now preparing to take forward the recommendations resulting from the work of the MRC Expert Group judged in open competition, with awards being made on the basis of the scientific quality of the proposals made on CFS/ME and issues and priorities discussed at a CFS/ME Research Prioritisation Meeting in June 2010. A note of this meeting along with further information on the work of the Expert Group can be found on the MRC website athttp://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC007174.
Further information will be published on the MRC website at www.mrc.ac.uk when available.
Officials have contacted NHSBT to request further information about its decision to exclude people with CFS/ME from donating blood.
NHSBT acknowledges that it was incorrect in the response it gave to the email enquiry that deferral was also for the protection of the recipient and it apologises for this error and any distress that it may have caused. The decision that CFS/ME sufferers would be permanently excluded from donating blood from 1 November was taken solely to protect the health of the donor.
This measure was introduced to the Donor Selection Guidelines (DSGs) following a review by the expert Blood Transfusion Services/HPA Joint Professional Advisory Committee (JPAC) into the possible link between a XMRV and CFS/ME. The JPAC found no evidence that XMRV could be a risk to transfusion recipients. However, the JPAC did decide to introduce, as an additional measure to the DSGs, the lifelong exclusion for CFS/ME sufferers so that even if symptoms had been resolved, a donation must not be taken. This brings guidance for people with this condition in line with other conditions where individuals are permanently excluded from blood donation to protect their own health.
Blood donation, by its nature, can put a donor’s body under significant physical stress and, in line with the UK blood services’ duty to protect the health of all donors, it was decided by the JPAC that this further measure should be introduced.
The JPAC will continue to monitor the situation and will advise on any changes should new evidence come to light.
The statement that the exclusion was for those with CFS/ME and fibromyalgia was also incorrect. At present, a donor with fibromyalgia would be accepted as long as they were well at the time and did not present any additional features of CFS/ME.
At all blood donation sessions there are a number of questions that every donor must be asked at health screening or that are on the Donor Health Check form. The answers to these questions would be expected to reveal any previous CFS/ME diagnosis. The questions include Have you ever had a serious illness or seen a doctor about your heart?; and
Have you ever had any hospital investigations or tests or operations?
In answering these questions, potential donors would be expected to disclose a previous CFS/ME diagnosis and blood donation staff would then review the specific DSGs entry for CFS/ME.
Additionally, all blood donation staff should be aware that anyone who has suffered from CFS/ME is now permanently excluded from blood donation and NHSBT are issuing a further notice to all staff to reiterate this and will draw this issue to the attention of the other three UK blood services.
NHSBT is sorry that its response was unclear and inaccurate and that a member of staff seemed unaware of the new exclusion. NHSBT is reviewing its internal communications processes so that in future all clinicians and public facing staff fully understand, and can properly explain, the rationale for any changes that are introduced to the donor selection criteria.
If NHSBT is informed that a donor with a past history of CFS/ME who has recovered has subsequently donated blood, they will be permanently excluded from making further donations.
Finally, with regard to current guidelines on the treatment of CFS/ME, the National Institute for Health and Clinical Excellence (NICE) is currently undertaking a review to decide whether its guideline on the diagnosis and management of CFS/ME in adults and children should be updated. I understand that NICE is due to publish its review decision shortly and I hope that you will understand that, for this reason, it would be inappropriate for the Department to pre-empt the outcome of this review and comment further at this time. Further information about the NICE guideline is available at http://guidance.nice.org.uk/CG53.
Thank you for your further recent emails to Andrew Lansley about xenotropic leukaemia virus-related virus (XMRV) and chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). I have been asked to reply on Mr Lansley’s behalf.
The detection of XMRV infection in humans is a rapidly moving field in medicine. The stark differences in prevalence of apparent infection seen globally in what amount to similar studies do present issues that will need further investigation, but are unlikely to be solely the result of different methodologies. Officials are assured that detection of the XMRV genome based on amplification of the number of copies present (PCR) is widely regarded as the best and most sensitive method available for this purpose.
The methods used to seek evidence of XMRV infection in English blood donors, which employed PCR and included appropriate controls, are able to detect the XMRV genome with high sensitivity and specificity. No evidence of the XMRV genome was found in any donor in the study conducted by NHS Blood and Transplant (NHSBT) and the Health Protection Agency (HPA). The completed study of 540 donors is a prelude to further extensive studies, which NHSBT is funding. Further research to develop and apply a test for an antibody to XMRV is being considered currently by the HPA and NHSBT.
Whilst XMRV is under continuing review by the UK Blood Services Joint Professional Advisory Committee, the international published evidence does not currently support concerns about a risk to the safety of the blood supply. There is at present no accepted causal role for XMRV in human disease.
As the Department set out in its first response, the National Expert Panel for New and Emerging Infections has considered all available evidence about XMRV and reported that no public health action is required at this time. The Advisory Committee on the Safety of Blood, Tissues and Organs, on the basis of current evidence, does not recommend further measures at present. Both groups will continue to monitor the situation.
With regard to research into CFS/ME, the Department of Heath funds research for health policy development, clinical and applied health research in the NHS, and covers the NHS costs incurred in supporting research funded by other bodies such as the Research Councils. As far as current UK research into CFS/ME is concerned, the bulk of the publicly funded work is being undertaken with funding from the Medical Research Council (MRC).
Neither the Department's National Institute for Health Research nor the MRC usually ring fence funds for expenditure on particular topics: research proposals in all areas compete for the funding available. Both organisations welcome applications for support for research into any aspect of human health and these are subject to peer review and The MRC is now preparing to take forward the recommendations resulting from the work of the MRC Expert Group judged in open competition, with awards being made on the basis of the scientific quality of the proposals made on CFS/ME and issues and priorities discussed at a CFS/ME Research Prioritisation Meeting in June 2010. A note of this meeting along with further information on the work of the Expert Group can be found on the MRC website athttp://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC007174.
Further information will be published on the MRC website at www.mrc.ac.uk when available.
Officials have contacted NHSBT to request further information about its decision to exclude people with CFS/ME from donating blood.
NHSBT acknowledges that it was incorrect in the response it gave to the email enquiry that deferral was also for the protection of the recipient and it apologises for this error and any distress that it may have caused. The decision that CFS/ME sufferers would be permanently excluded from donating blood from 1 November was taken solely to protect the health of the donor.
This measure was introduced to the Donor Selection Guidelines (DSGs) following a review by the expert Blood Transfusion Services/HPA Joint Professional Advisory Committee (JPAC) into the possible link between a XMRV and CFS/ME. The JPAC found no evidence that XMRV could be a risk to transfusion recipients. However, the JPAC did decide to introduce, as an additional measure to the DSGs, the lifelong exclusion for CFS/ME sufferers so that even if symptoms had been resolved, a donation must not be taken. This brings guidance for people with this condition in line with other conditions where individuals are permanently excluded from blood donation to protect their own health.
Blood donation, by its nature, can put a donor’s body under significant physical stress and, in line with the UK blood services’ duty to protect the health of all donors, it was decided by the JPAC that this further measure should be introduced.
The JPAC will continue to monitor the situation and will advise on any changes should new evidence come to light.
The statement that the exclusion was for those with CFS/ME and fibromyalgia was also incorrect. At present, a donor with fibromyalgia would be accepted as long as they were well at the time and did not present any additional features of CFS/ME.
At all blood donation sessions there are a number of questions that every donor must be asked at health screening or that are on the Donor Health Check form. The answers to these questions would be expected to reveal any previous CFS/ME diagnosis. The questions include
Have you ever had a serious illness or seen a doctor about your heart?; and
In answering these questions, potential donors would be expected to disclose a previous CFS/ME diagnosis and blood donation staff would then review the specific DSGs entry for CFS/ME.
Additionally, all blood donation staff should be aware that anyone who has suffered from CFS/ME is now permanently excluded from blood donation and NHSBT are issuing a further notice to all staff to reiterate this and will draw this issue to the attention of the other three UK blood services.
NHSBT is sorry that its response was unclear and inaccurate and that a member of staff seemed unaware of the new exclusion. NHSBT is reviewing its internal communications processes so that in future all clinicians and public facing staff fully understand, and can properly explain, the rationale for any changes that are introduced to the donor selection criteria.
If NHSBT is informed that a donor with a past history of CFS/ME who has recovered has subsequently donated blood, they will be permanently excluded from making further donations.
Finally, with regard to current guidelines on the treatment of CFS/ME, the National Institute for Health and Clinical Excellence (NICE) is currently undertaking a review to decide whether its guideline on the diagnosis and management of CFS/ME in adults and children should be updated. I understand that NICE is due to publish its review decision shortly and I hope that you will understand that, for this reason, it would be inappropriate for the Department to pre-empt the outcome of this review and comment further at this time. Further information about the NICE guideline is available at http://guidance.nice.org.uk/CG53.
I hope this reply is helpful.
Yours sincerely,
Christopher Bird
Department of Health