Message from CII Director W. Ian Lipkin Regarding the XMRV/MLV CFS/ME
Dear Colleagues and Friends in the CFS/ME Community:
This letter is written to clarify the status of the XMRV/MLV CFS/ME study I am coordinating at the request of the National Institutes of Health. 
Although frequently described as the “Lipkin Study,” it is in fact the Alter, Bateman, Klimas, Komaroff, Levine, Lo, Mikovits, Montoya, Peterson, Ruscetti, and Switzer study, designed by these 11 investigators to bring their best methods for case ascertainment and characterization and state-of-the-art molecular and serological diagnostic tools to address the question of whether a retrovirus is associated with disease. 
My role in conjunction with Mady Hornig and Bruce Levin at Columbia University is to ensure that the study represents an appropriately powered, definitive, representative sample of CFS/ME patients across the United States; to receive and distribute samples; and to assess results obtained in individual laboratories for consistency and evidence for or against an association between retroviral signal and disease. 
I use the term “signal” because any finding related to a retrovirus, whether infectious or noninfectious, genetic material, protein, or antibody, may provide insights into disease or allow development of diagnostic tests even if a causative relationship is not established. My condition on accepting this charge from the NIH and the clinical and laboratory investigators is that each participant agree to unconditionally accept group criteria for defining cases to be used in this study. 
Laboratory investigators were also required to unequivocally endorse their results at the conclusion of the study. Several months were required to develop clinical criteria for case and control definition and to complete approvals for human subject protection. 
We encountered additional delays when Dr. Mikovits could no longer pursue her work at the WPI. At that juncture, some parties suggested that the work proceed at WPI without her. However, in my judgment, the value of this study rests in its inclusion of the original investigators who reported the XMRV/MLV findings. 
Thus, I was grateful when we found a way to fully engage Dr. Mikovits. At the time of this writing we have collected and distributed for laboratory analysis samples from 123 CFS/ME patients and 88 matched control subjects. We intend to complete collection and analysis of samples from 150 patients and 150 controls in early 2012. 
There is criticism in some quarters that this study is unnecessary given results obtained by other investigators with other samples. However, the participating clinical and laboratory investigators and our team at Columbia do not agree. We are fully committed to completing the work rapidly and rigorously. 
For those who continue to express concerns that this study is an inappropriate use of resources in a challenging fiscal environment, please be assured that more than 85% of the funding associated with this initiative is invested in patient recruitment and characterization and sample collection, archiving, and distribution. 
Thus, irrespective of study outcome there will be unprecedented opportunity to explore hypotheses other than that disease is due to XMRV or MLV infection. 
W. Ian Lipkin, MD
Director, Center for Infection and Immunity
Here are my comments:
 This is a link, but I could not get it to work, also not from patients' forums nor from ERV's blog, where I first read it. The present version, with more empty lines than the other versions I saw, but textually the same, is taken from a thread on Phoenix Rising, where there is more context, including a reported brief mail from dr. Mikovits:
It would be nice to have a working link to the original, but then it also may be my browser or internet connection.
 Actually, "the Lipkin study" has been in the works for quite a while, and was started before the retractions of the Lombardi and the Lo papers and before the dismissal of dr. Mikovits from the WPI, and before dr. Mikovits's arrest. It was supposed to have been finished by now - the end of 2011 - but indeed there was interference of various kinds, and it is nice to see dr. Lipkin does come with a statement on the present status of the study.
 I take it the end - "to address the question of whether a retrovirus is associated with disease" - is as originally formulated. It is good to see that dr. Lipkin has succeeded in securing the collaboration of "Alter, Bateman, Klimas, Komaroff, Levine, Lo, Mikovits, Montoya, Peterson, Ruscetti, and Switzer", since all of these must be considered as knowledgeable at the very least, and many are trusted by patients, and indeed have treated many patients.
Although it seems likely to me that the answer to "the question of whether a retrovirus is associated with disease" is "No", the sort of design of the study and the collaborators of the study all seem the right ones, so I am in favour of it, were it only to have a really clear and definite answer to that question.
 I have no knowledge of Hornig and Levin, but I am definitely much interested in there coming to be "an appropriately powered, definitive, representative sample of CFS/ME patients across the United States", because that seems to be one of the many things that so far have been missing.
 I suppose "signal" is a diplomatic term, and I also suppose it is justified. And I like that "each participant agree to unconditionally accept group criteria for defining cases to be used in this study": I want clear unequivocal results.
 I am quite interested in the "clinical criteria for case and control definition", for one of the great problems of much empirical research / "evidence-based medicine" in the field of ME/CFS is that it is not clear what the criteria are by which the patients have been selected, or it is quite clear that they have been selected by criteria - "enduring fatigue" - that select many more patients than those which would satisfy the Canada Criterions or the International Criterions developed from these, that seem the most sensible and biomedically informed.
 This may be read as another example of dr. Lipkin's diplomatic gifts, but I agree that if the study is to be done, it is best done with the original design that includes dr. Mikovits, whose group, then at the WPI, started it all.
 A "complete collection and analysis of samples from 150 patients and 150 controls in early 2012", provided these are well characterized is very nice to have, for this and for further research into ME/CFS.
 Alternatively, dr. Lipkin could argue that he simply is doing what he agreed to do, and succeeded in getting a group of the best collaborators and a set of well-prepared data, which are two items that so far have not been assembled to study ME/CFS seriously - and I would agree.
 Alternatively, dr. Lipkin could argue that a considerable part of the work and set-up predate the retraction of the Lombardi et al and the Lo et al paper, and the difficulties between the WPI and dr. Mikovits. And indeed:
 That "there will be unprecedented opportunity to explore hypotheses other than that disease is due to XMRV or MLV infection", indeed on the basis of a well-characterized sample of patients with ME/CFS, with the collaboration of biomedical scientists who have done a lot of work on and around ME/CFS, seems to me to be quite good news.
Conclusion: I am quite in favour of it, because as regards XMRV and retroviruses this study may conclusively settle - with high probability, at least, based on good evidence - what did happen and what went wrong, and because it also provides very good opportunities for further research into ME/CFS, by some of the best specialists, on what is hopefully a very good set of data from a well-characterized set of patients.