Research | results of the ‘Lipkin Study’ | published in ‘mBio’ | 18 September 2012

From mBio, an open-access journal published by the America Society for Microbiology. 18 September 2012.

A Multicenter Blinded Analysis Indicates No Association between Chronic Fatigue Syndrome/Myalgic Encephalomyelitis and either Xenotropic Murine Leukemia Virus-Related Virus or Polytropic Murine Leukemia Virus

Harvey J. Alter(a), Judy A. Mikovits(b), William M. Switzer(c), Francis W. Ruscetti(d), Shyh-Ching Lo(e), Nancy Klimas(f,g), Anthony L. Komaroff(h), Jose G. Montoya(i), Lucinda Bateman(j), Susan Levine(k), Daniel Peterson(l), Bruce Levin(m), Maureen R. Hanson(n), Afia Genfi(o), Meera Bhat(o), HaoQiang Zheng(c), Richard Wang(a), Bingjie Li(e), Guo-Chiuan Hung(e), Li Ling Lee(n), Stephen Sameroff(o), Walid Heneine(c), John Coffin(p), Mady Hornig(o), and W. Ian Lipkin(o)

(a) Department of Transfusion Medicine, Warren G. Magnuson Clinical Center, National Institutes of Health, Bethesda, Maryland, USA;
(b) Mikovits Consulting, Oxnard, California, USA;
(c) Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA;
(d) Cancer and Inflammation Program, Frederick National Laboratory for Cancer Research, Frederick, Maryland, USA;
(e) Tissue Safety Laboratory, Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland, USA;
(f) Nova Southeastern University, Fort Lauderdale Florida, USA;
(g) Miami Veterans Affairs Medical Center, Miami, Florida, USA;
(h) Brigham and Women’s Hospital, Boston, Massachusetts, USA;
(i) Infectious Disease Clinic, Stanford University, Palo Alto, California, USA;
(j) Fatigue Consultation Clinic, Salt Lake City, Utah, USA;
(k) Levine Clinic, New York, New York, USA;
(l) Simmaron Research Institute, Incline Village, Nevada, USA;
(m) Department of Biostatistics, Columbia University, New York, New York, USA;
(n) Department of Molecular Biology and Genetics, Cornell University, Ithaca, New York, USA;
(o) and Center for Infection and Immunity, Columbia University, New York, New York, USA; and
(p) Department of Molecular Biology and Microbiology, Tufts University, Boston, Massachusetts, USA.

Address correspondence to W. Ian Lipkin, wil2001@columbia.edu.

Editor Michael Buchmeier, University of California, Irvine

ABSTRACT

The disabling disorder known as chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME) has been linked in two independent studies to infection with xenotropic murine leukemia virus-related virus (XMRV) and polytropic murine leukemia virus (pMLV). Although the associations were not confirmed in subsequent studies by other investigators, patients continue to question the consensus of the scientific community in rejecting the validity of the association. Here we report blinded analysis of peripheral blood from a rigorously characterized, geographically diverse population of 147 patients with CFS/ME and 146 healthy subjects by the investigators describing the original association. This analysis reveals no evidence of either XMRV or pMLV infection.

IMPORTANCE Chronic fatigue syndrome/myalgic encephalomyelitis has an estimated prevalence of 42/10,000 in the United States, with annual direct medical costs of $7 billion. Here, the original investigators who found XMRV and pMLV (polytropic murine leukemia virus) in blood of subjects with this disorder report that this association is not confirmed in a blinded analysis of samples from rigorously characterized subjects. The increasing frequency with which molecular methods are used for pathogen discovery poses new challenges to public health and support of science. It is imperative that strategies be developed to rapidly and coherently address discoveries so that they can be carried forward for translation to clinical medicine or abandoned to focus resource investment more productively. Our study provides a paradigm for pathogen dediscovery that may be helpful to others working in this field.

Footnotes

H.J.A., J.A.M., and W.M.S. contributed equally to this work.

Citation Alter HJ, et al. 2012. A multicenter blinded analysis indicates no association between chronic fatigue syndrome/myalgic encephalomyelitis and either xenotropic murine leukemia virus-related virus or polytropic murine leukemia virus. mBio 3(5):e00266-12. doi:10.1128/mBio.00266-12.

Received 1 August 2012
Accepted 20 August 2012
Published 18 September 2012

Copyright © 2012 Alter et al.

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