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
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.
