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; Judy A. Mikovits; William M. Switzer; Francis W. Ruscetti; Shyh-Ching Lo; Nancy Klimas; Anthony L. Komaroff; Jose G. Montoya; Lucinda Bateman; Susan Levine; Daniel Peterson; Bruce Levin; Maureen R. Hanson; Afia Genfi; Meera Bhat; HaoQiang Zheng; Richard Wang; Bingjie Li; Guo-Chiuan Hung; Li Ling Lee; Stephen Sameroff; Walid Heneine; John Coffin; Mady Hornig; W. Ian Lipkin

doi:10.1128/mBio.00266-12

mBio (Nov 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,
Judy A. Mikovits,
William M. Switzer,
Francis W. Ruscetti,
Shyh-Ching Lo,
Nancy Klimas,
Anthony L. Komaroff,
Jose G. Montoya,
Lucinda Bateman,
Susan Levine,
Daniel Peterson,
Bruce Levin,
Maureen R. Hanson,
Afia Genfi,
Meera Bhat,
HaoQiang Zheng,
Richard Wang,
Bingjie Li,
Guo-Chiuan Hung,
Li Ling Lee,
Stephen Sameroff,
Walid Heneine,
John Coffin,
Mady Hornig,
W. Ian Lipkin

Affiliations

Harvey J. Alter: Department of Transfusion Medicine, Warren G. Magnuson Clinical Center, National Institutes of Health, Bethesda, Maryland, USA
Judy A. Mikovits: Mikovits Consulting, Oxnard, California, USA
William M. Switzer: Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA
Francis W. Ruscetti: Cancer and Inflammation Program, Frederick National Laboratory for Cancer Research, Frederick, Maryland, USA
Shyh-Ching Lo: Tissue Safety Laboratory, Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland, USA
Nancy Klimas: Nova Southeastern University, Fort Lauderdale Florida, USA
Anthony L. Komaroff: Brigham and Women’s Hospital, Boston, Massachusetts, USA
Jose G. Montoya: Infectious Disease Clinic, Stanford University, Palo Alto, California, USA
Lucinda Bateman: Fatigue Consultation Clinic, Salt Lake City, Utah, USA
Susan Levine: Levine Clinic, New York, New York, USA
Daniel Peterson: Simmaron Research Institute, Incline Village, Nevada, USA
Bruce Levin: Department of Biostatistics, Columbia University, New York, New York, USA
Maureen R. Hanson: Department of Molecular Biology and Genetics, Cornell University, Ithaca, New York, USA
Afia Genfi: Center for Infection and Immunity, Columbia University, New York, New York, USA
Meera Bhat: Center for Infection and Immunity, Columbia University, New York, New York, USA
HaoQiang Zheng: Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA
Richard Wang: Department of Transfusion Medicine, Warren G. Magnuson Clinical Center, National Institutes of Health, Bethesda, Maryland, USA
Bingjie Li: Tissue Safety Laboratory, Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland, USA
Guo-Chiuan Hung: Tissue Safety Laboratory, Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland, USA
Li Ling Lee: Department of Molecular Biology and Genetics, Cornell University, Ithaca, New York, USA
Stephen Sameroff: Center for Infection and Immunity, Columbia University, New York, New York, USA
Walid Heneine: Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA
John Coffin: Department of Molecular Biology and Microbiology, Tufts University, Boston, Massachusetts, USA
Mady Hornig: Center for Infection and Immunity, Columbia University, New York, New York, USA
W. Ian Lipkin: Center for Infection and Immunity, Columbia University, New York, New York, USA

DOI: https://doi.org/10.1128/mBio.00266-12
Journal volume & issue: Vol. 3, no. 5

Abstract

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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.

Published in mBio

ISSN: 2161-2129 (Print); 2150-7511 (Online)
Publisher: American Society for Microbiology
Country of publisher: United States
LCC subjects: Science: Microbiology
Website: https://journals.asm.org/journal/mbio

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