We've all heard about the need to for different labs to look at the same samples. Now Dr. Enlander is proposing a large double blinded multi-lab study that he believes will tell us whether the problem is in the different methodologies or the different patients. There is no breakthru in laboratory procedures here; this is simply a chance for a number of CFS labs to test exactly the same patients and see where they disagree or agree. Dr. Enlander would be coordinating the study. It would take about $10,000 on his side to bring it off.
Proposal to test the presence or absence of XMRV virus in the CFS in a double-blind trial using replicant patient specimens in five different labs.
Preamble The presence of XMRV virus in that CFS patients was reported in the Science in October 2009. This caused great excitement in the scientific world, as an infective organism was suggested as the etiology of CFS. The excitement abated as other labs attempted to replicate the result. Papers were soon published denying the presence of the XMRV virus in the CFS patients. Discussion then opened with various researchers debating the possibility of poor storage of specimens, poor selection of CFS patients without proper criteria, different methodology in the determining the presence of the virus, and other aspects in the research methods. Patients and physicians were then left in a quandary whether the original research gave us insight into a viral etiology. Indeed the picture became more blurred.
We will attempt to determine whether testing methods or patient selection were different or faulty. We propose to replicate a study in the five labs that were prominent in the disputed discussion, by replicating patient and control specimens in divided aliquots in a double-blind trial.
Method 100 patients , who have been diagnosed by the Fukuda and Canadian criteria for CFS, and 100 matched controls will have 15 ML blood drawn (two vials) . The 15 ML blood specimens will be combined into a single tube and will be centrifuged . The supernatants will be refrigerated. Each patient or control specimen will be numbered randomly and blindly 1 to 200, each specimen will then be divided into five aliquots and labeled A,B,C,D and E . We will thus have 1000 test aliquots to be divided between five viral test labs.
We will send 200 aliquots in frozen containers to five virus testing laboratories; A) Whitmore Peterson Institute in Reno Nevada, B) Jonathan Kerr in London, C) Simon Wessley group in London, D) Gow in Glasgow, and E) de MeirLeir in Brussels The selection of these labs does not mean that we recommend their methods. These labs have not replicated the original thesis. Perhaps, the comparison of duplicate specimens in a double blind trial can be revealing.
Results The test results will be sent to Dr. Enlander in New York, where the blind will be opened and the results tabulated. As each lab has received the same patient and control aliquots, we can attempt to correlate differences in testing method without the problem of bias in patient selection.