HHS Coordinating Xenotropic Murine Leukemia Virus-Related Virus (XMRV) Scientific Activities
The U.S. Department of Health and Human Services (HHS) has formed an interagency scientific working group on XMRV. The Blood XMRV Scientific Research Working Group will report to the Department’s Blood, Organ and Tissue Senior Executive Council through established mechanisms. No formal statement has been issued yet, but the working group includes representatives from the DHHS Office of Public Health and Science, the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). The working group will have scientific responsibilities for investigation of XMRV as it relates to the blood supply and CFS. Suzanne D. Vernon, PhD, the CFIDS Association’s scientific director, has been asked to participate in the XMRV scientific working group.
Dr. Jerry Holmberg
Dr. Jerry Holmberg of the HHS Office of Public Health and Science made a brief presentation on Oct. 30, 2009 to the DHHS CFS Advisory Committee. He described the existing response systems that address threats to blood safety, such as new and emerging infectious agents like XMRV. The HHS Blood XMRV Scientific Research Working Group will be chaired by a representative of the NIH’s National Heart, Lung and Blood Institute (NHLBI) and will collaborate closely with the agencies in charge of these systems, including the NHLBI’s Retrovirus Epidemiology Donor Study (REDS). REDS was created in 1989 to address risks associated with HIV-1, HIV-2, HTLV-1 and HTLV-2 in the general blood supply.
In more recent communications with Dr. Holmberg, he stated that the Blood XMRV Scientific Research Working Group is taking a three-stage approach to its handling of the issues related to XMRV and the possible link to human disease. The first stage will be to standardize and validate laboratory methods and reagents for XMRV testing. This is important since variations in sample collection and laboratory procedures can produce discrepant results. These standardized approaches will be used initially to test 1,200 healthy donors’ blood samples and 100 CFS patients’ blood samples collected by Dr. Judy Mikovits of the Whittemore Peterson Institute. Stage two will assess the prevalence of XMRV in the general population and blood supply, as well as in other CFS patient cohorts. The third stage will be a series of studies to understand how XMRV is transmitted, whether it causes human disease, and how it affects various subgroups of the population.
The immediate focus is to ascertain any risks to the general blood supply that XMRV might pose, but the scientific working group is also addressing validation studies for diagnostic tests and if necessary, potential blood screening tests. If the studies indicate that screening is required for blood products, blood screening tests, must be submitted to and approved by the FDA before they can be marketed. Neither of the tests currently being offered by two commercial labs has been reviewed by the FDA.
According to CDC, their studies using samples obtained from the Whittemore Peterson Institute have HHS attention. The Laboratory Branch in CDC’s Division of HIV/AIDS Prevention is doing the XMRV testing and not the CDC CFS research group in the Division of Viral and Rickettsial Diseases.
Representatives from the FDA attended the XMRV meeting sponsored by Abbott Laboratories at Cleveland Clinic on Nov. 11, 2009. Dr. Robert Silverman of the Cleveland Clinic gave a seminar about XMRV for HHS staff on Dec. 2, 2009.
Dr. Holmberg emphasizes the need for careful application of scientific methods to ensure that these studies are conducted with exceptionally high rigor and reliability so that the results provide a solid scientific foundation for moving forward. He understands the strong interest within the CFS patient community for swift action and definitive answers, and expressed the high priority that this subject is receiving within a broad range of functions within the Department of Health and Human Services.
The CFIDS Association will provide updates on these important activities as new information becomes available.
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