[7][16][17][18] Amid allegations of sloppiness and scientific misconduct,[19] WPI personnel criticised the methods and motives of other scientists, implying that the negative results were part of a "cover-up" or a "bias against this disease (CFS)".
[20][21] WPI was created by the parents of a CFS patient, Annette and Harvey Whittemore,[22] and by Daniel Peterson, an early researcher of the illness.
[24] Judy Mikovits joined as research director in 2006,[22] but was terminated by WPI in October 2011 for not turning her work over to another scientist[25] while also coming under investigation for alleged manipulation of data in her publications related to XMRV.
[29] Whittemore stated that numerous doctors were unable to help her daughter, and that the first major improvement came ten years after her diagnosis when she was treated by Peterson with the experimental antiviral drug Ampligen.
[30] Hemispherx's new drug application for Ampligen, which permits sale and marketing, was rejected by the FDA in December 2009 and the agency asked for another clinical study.
[31] Interviewed by The New York Times, Whittemore said that "she had long believed that the syndrome was an infectious disease, but that scientists had rejected the idea",[22] and decided that, "if there was a place of our own where we could find the answers, we could do it more quickly.
Research began in 2006 with the opening of a small laboratory and an office on the University of Nevada, Reno campus under the direction of Judy Mikovits.
Peterson was reported to be working with Jay Levy, one of the original discoverers of HIV, to try to determine whether XMRV was truly present in the same patients examined in the Science study.
[42][43] In September 2009, WPI announced that Mikovits and collaborator Jonathan Kerr of St. George’s College in London received a $1.6 million, five-year grant from the National Institute of Allergy and Infectious Diseases for their proposal to develop new "strategies to decipher the pathophysiology of chronic fatigue syndrome".
She kept the project secret from Peterson and the Whittemores, fearful that skeptics would try to derail her work, but sent test samples to Bob Silverman and to the lab of her mentor at NCI, Frank Ruscetti.
In 2009, Lombardi et al. reported in the journal Science that they had detected XMRV DNA in 68 of 101 (67%) CFS patients, versus 8 of 218 (3.7%) healthy control subjects.
[20] The WPI study was followed by worldwide media coverage, including reports by the BBC, National Public Radio, The New York Times and The Wall Street Journal.
[66][67] Mikovits and Ruscetti attributed the failure to replicate their results to the use of different PCR reactions and to the examination of patients who did not satisfy the same CFS diagnostic criteria.
[17] In December 2010, four independent articles published in the journal Retrovirology[17] presented evidence that reported XMRV detection could be explained by contamination of laboratory reagents,[71] tissue samples[72] and blood.
[74] The British Medical Journal responded with an article entitled, "Chronic fatigue syndrome is not caused by XMRV virus, study shows".
Two groups showed evidence that XMRV is a recombinant of two mouse retroviruses, which infected a prostate cancer cell line during passage through nude mice.
"[18] Robert Silverman, who was a co-author of the original XMRV-CFS article but is no longer collaborating with Mikovits,[20] told the Chicago Tribune that he was "concerned about lab contamination, despite our best efforts to avoid it".
[21] In response to the contradictory British results, Mikovits stated that scientists had doctored their studies to reach a predetermined conclusion as part of an insurance company conspiracy.
[9] Annette Whittemore expressed the opinion that the response to her organization's claims was political, while the director of clinical services, Deckoff-Jones, characterized the negative research findings as a "cover-up and baseless attacks against Dr.
[21] There is currently no consensus that XMRV is capable of infecting humans, much less causing disease; the rush to prescribe antiretrovirals has been described as premature and based on "an unproven hypothesis".
[49] Another criticism is that even if XMRV did cause CFS and antiviral medications were effective against the virus, rigorous trials would be needed to establish safety, efficacy, and optimal dosing.
[21] Virologist John Coffin observed that the original paper established the virus neither as a cause of CFS nor as a viable marker; in a Science news article, Sam Kean notes that the utility of the test for a patient or a physician is unclear.
"[77] The Wall Street Journal has reported that WPI and other laboratories are participating in a United States federal working group to determine the prevalence of XMRV in the blood supply and the suitability of different detection methods.