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The following note just arrived from Heidi Bauer, via the Blood Products Advisory Committee Meeting being held today, December 14, 2010. Thank you, Heidi:
“The Blood Products Advisory Committee has been asked to consider the issue of donor testing for MLV-related retroviruses even in the absence of confirmed disease causation. Absent evidence that these viruses have a causal role in any human disease it seems reasonable that the following criteria be met prior to the implementation of donor screening:
“1. evidence of transfusion transmission of these viruses
“2. consistent evidence of association of these viruses with disease, and
“3. development of validated assays for these agents that detect infected individuals but do not implicate non-infected individuals.
“The presence of a virus, and even transfusion transmission of an agent, is not, in and of itself a reason to implement donor referral or screening. Since no causal association of XMRV with human disease has been demonstrated, a decision to introduce a blood donor screening assay, were one to become available, would appear premature. Many commensal viruses, for example Anellovirus species, are known to be transmitted by transfusion but despite extensive study have not been associated with disease. In the absence of direct evidence of causation, a decision to implement testing should be based on an assessment of recipient risk that includes the prevalence of the infection in the donor population, the transmission rate to recipients and the current best assessment of the risk of recipient harm, compared to currently accepted risks of transfusion.
“Members of the blood transfusion community are concerned about the potential threat to the blood supply posed by XMRV/MLV and are actively involved in efforts to validate quality control panels and develop tests for the detection of MLV-related retroviruses. However we believe that current evidence does not support introducing any test methodology at this time.”
Phase IIb Setup
XMRV post samles: blood collected into EDTA tubes by an independent phelbotomist at pts' home or work from the same 4 subjects (One patient had independently started ARV)
The pedigreed neg subject used for the analytical panel and phasse IIa panel was bled by the same phlebotomist a a control. Plebotomist directly supplied the samples to BSRI for processing. Samples separated into tubes and processed the same day, or left at 4 C for w2 days. Each sample processed into PBMC, WB & plasma.
Analysis -- blinded panels distributed by BSRI to WPI, CDC, NCI and Gen-Probe for testing. Two set of the panel were retained by BSRI to distrubte for follow-up work as neede. Results were reported back to BSRI and decoded.
Who knows how long it would have taken with more!
A. Introduction and Background, Indira Hewlett, Ph.D., DETTD, OBRR, FDA (10)
B. Summary of Current Research on MLV-related Human Retroviruses and Disease Association, Jonathan Stoye, Ph.D., NIMR, UK ( 25)
C. Recent Studies of Epidemiology of MLV-related Human Retroviruses:
i. U.S. Study, Shyh-Ching Lo, M.D., OCTGT, FDA (15)
ii. U.S. Study. Maureen Hanson, Ph.D., Cornell University (15)
iii. UK Study, Judy Mikovits, Ph.D. Whitmore Peterson Institute (15)
D. Animal Studies: Potential Transfusion Transmission of MLV-related Human Retroviruses, Francois Villinger, Emory University (20)
E. Update of Blood XMRV Working Group Activities, Graham Simmons, Ph.D., BSRI (15)
F. Prospective and Retrospective U.S. Donor Surveillance Studies, Michael Busch, M.D., Ph.D., Blood Systems Research Institute (15)
G. Assay Development Efforts on MLV-related Human Retroviruses, Rachel Bagni, Ph.D., National Cancer Institute (20)