CFIDSLink e-newsletter:
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 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 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
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 test, 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 has 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.
Links:
December edition of CFIDSLink:
http://www.cfids.org/archives/2006-2010-cfidslink/december-2009.asp
CFIDS Association's XMRV Resources:
http://www.cfids.org/XMRV/default.asp#info
DHHS Statement on Blood Safety and Availability:
http://www.cfids.org/xmrv/blood-supply-ophs.pdf
NCI Q&A About XMRV:
http://www.cancer.gov/newscenter/pressreleases/XMRV_QandA
Summary of the October 2009 CFS Advisory Committee meeting:
http://www.cfids.org/cfidslink/2009/110401.asp
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