FDA and NIH confirm XMRV findings

Saturday, 26 June 2010 11:30

FDA and NIH confirm XMRV findings in Chronic Fatigue Syndrome (ME/CFS

Original Press Release from The Netherlands

Gendringen (NL), June 22, 2010. The FDA and the NIH have independently confirmed the XMRV findings as published in Science, October last. This confirmation was issued by Dr. Harvey Alter of the NIH during a closed workshop on blood transfusion held on May 26-27 in Zagreb. Two journalists from the Dutch magazine for health professionals, ORTHO, who have been working on XMRV stories for several months, were able to obtain a copy of the Alter lecture.

In the October 8, 2009 issue of Science Express, the Lombardi-Mikovits group at the Whittemore Peterson Institute (WPI), the Cleveland Clinic and the National Cancer Institute (NCI) reported that 67% of 101 chronic fatigue syndrome (CFS) patients tested positive for infection with xenotropic murine retrovirus (XMRV). Only 3.7% of 218 healthy subjects tested were positive for this gammaretrovirus. Since that time, a number of research groups have proved unable to independently confirm these findings.

On Friday last, the AABB released an Association Bulletin recommending that its member blood collectors actively discourage potential donors who have been diagnosed with CFS from donating blood or blood components. This interim measure was proposed by the AABB Interorganizational Task Force on XMRV. This Task Force includes representatives from several government agencies, including the Center for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA) and the National Institutes of Health (NIH).

The fact that the measure was introduced suggests the presence of information not yet published. The ORTHO journalists were able to obtain a pdf document of the lecture given by Harvey Alter at the IPFA/PEI 17th Workshop on Surveillance and screening of Blood Borne Pathogens in Zagreb. The International Plasma Fractionation Association (IPFA) represents the not-for-profit organizations around the world involved in plasma fractionation. The IPFA is based in Amsterdam, the Netherlands.

The highly-experienced Dr. Harvey Alter is Clinical Studies Chief at the Infectious Diseases and Immunogenetics Section of the Department of Transfusion Medicine at the NIH Clinical Center in Bethesda. "The data in the Lombardi, et al Science manuscript are extremely strong and likely true, despite the controversy", was one comment on the XMRV findings reported by Alter in Zagreb. "Although blood transmission to humans has not been proved, it is probable. The association with CFS is very strong, but causality not proved. XMRV and related MLVs are in the donor supply with an early prevalence estimate of 3%‐7%. We (FDA & NIH) have independently confirmed the Lombardi group findings."

ORTHO contacted Dr. Harvey Alter today for a reaction. He did not want to comment, but confirmed that a paper is soon to be published.

ORTHO is a Dutch magazine for health professionals focusing on nutrition and dietary supplements. ORTHO has been publishing reports on CFS since 1988. Editor-in-chief: Gert E. Schuitemaker (PhD). Tel: + 31 (0) 315 695211 / + 49 (0) 170 808 9484. E-mail: ortho@orthoeurope.com.

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written by jud, June 30, 2010

SIGN THE XMRV PETITION!

http://healthcare.change.org/petitions/view/xmrv_allow_science_to_progress

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written by Maff, July 21, 2010

UPDATE: It seems that an indefinate delay in the publication of Dr. Harvey Alter's study results has now been imposed. Whether this is the result of questions over research methods (given positive results compared to the CDC's negative results) or something more sinister is explored by Cort Johnson in his column - XMRV at the FED: Conspiracy or Confusion?

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written by Maff, August 24, 2010

UPDATE: Yesterday the paper was finally published by PNAS and the results do indeed confirm that the presence of retroviral DNA is far more common in hronic Fatigue Syndrome patients than in healthy people - there is a twist however. Alter et al did not find evidence of XMRV specifically but rather genetic material from the larger group of retroviruses that include XMRV, namely murine leukemia virus (MLV)-related viruses.

These findings therefore support some role for retroviruses in ME/CFS but suggest the picture may be more complex than originally thought (isn't it always in ME/CFS!). The author's point out that this study cannot answer questions of causality but that it points to the need for further investigation to obtain these much needed answers.

Read the study abstract here - Detection of MLV-related virus gene sequences in blood of patients with chronic fatigue syndrome and healthy blood donors