AABB convened an Interorganizational Task Force on Xenotropic Murine Leukemia Virus-Related Virus, or XMRV, in December 2009. This task force is charged with reviewing the available data on the potential transmission of XMRV through blood transfusion, making recommendations for further action to assess the risk of transmission and developing appropriate messages for donors, recipients and the public. The task force includes U.S. and Canadian representatives from the blood community, a patient advocacy representative, XMRV subject matter experts and liaisons from several U.S. government agencies, including the Office of the Assistant Secretary for Health, the Centers for Disease Control and Prevention, and the Food and Drug Administration. Dr. Harvey G. Klein, Chief of the Department of Transfusion Medicine at the National Institutes of Health Clinical Center, serves as the task force chair.
AABB and its task force members strongly support the use of rational, scientifically based blood donor deferral policies. The AABB Board of Directors and the AABB Interorganizational Task Force on XMRV continue to monitor activity and evidence-based research on the potential transfusion transmissibility of XMRV and, as appropriate, will provide further communication and guidance to the blood banking and transfusion medicine community.
As an interim measure, and until further definitive data are available, AABB released Association Bulletin #10-03 in June 2010,recommending that blood-collecting organizations — through the use of donor education materials available at the donation site — actively discourage potential donors who have ever been diagnosed by a physician with chronic fatigue syndrome, or CFS (also known as chronic fatigue and immune dysfunction syndrome [CFIDS] or myalgic encephalomyelitis [ME]) from donating blood or blood components. In addition, donors with symptoms of CFS would be deferred if, on the day of donation, they respond negatively to the question “Are you feeling well today?”
AABB member institutions are required to follow all federal regulations regarding donor eligibility. At present, there are no specific federal recommendations regarding deferral of individuals with diseases or syndromes that have been associated with XMRV, as there is no proof that XMRV is the causative agent of any disease. At its Dec. 14, 2010, meeting, the Blood Products Advisory Committee, or BPAC, with a number of dissenting votes, recommended to FDA that potential blood donors be questioned about a medical history or diagnosis of CFS as a basis for indefinite deferral from blood donation. After reviewing the basis and the outcome of BPAC’s discussions and the totality of the available data, and after considering possible changes to the AABB position presented at the BPAC meeting, the task force continues to recommend the policy described in AABB Association Bulletin #10-03 and maintains the position that adding a question to the accepted donor history questionnaire is not an appropriate measure at this time. The task force also is aware of ongoing efforts to collect additional data on donors who have been deferred as a result of the current AABB policy. These findings will at least partially inform an assessment of the efficacy of the current policy in deferring diagnosed CFS patients. The task force believes that FDA should consider in its decision-making these findings as well as those of other studies that have been publicized since the December BPAC meeting.
Background information about XMRV and its characteristics that specifically relate to potential transfusion transmissibility can be found in the AABB XMRV fact sheet, published by the AABB Transfusion Transmitted Diseases Committee in April 2010 (for which a revision based on evidence published in the interval is currently in editorial review). In January 2011, the task force published its collective analysis of the risk posed by XMRV and related viruses in the online edition of the journal Transfusion (“Xenotropic Murine Leukemia Virus-Related Virus [XMRV] and Blood Transfusion: Report of the AABB Interorganizational XMRV Task Force”). The task force will continue to examine new data concerning XMRV and other murine leukemia-related viruses and their potential transfusion-transmission risk and suggest revisions to the fact sheet as indicated.
Maintaining the safety of the blood supply is an essential priority of the blood banking and transfusion medicine community. Accurate donor histories and medically supportable donor deferral criteria are critical to the continued safety of blood transfusion. AABB and its member organizations are appreciative of all individuals who want to donate blood, but strongly urge that only those who are eligible and healthy actually do so.