Bob,
I think collecting what do DO know about the Lipkin study would be helpful because I've seen bits and pieces but mostly without references, etc.
I've gathered the relevent info about Lipkin's study, and the BWG study, and like I mentioned earlier, I find it very reassuring...
Lipkin Study
Basically, Lipkin says that even if the WPI are the only group, in his study, who can detect XMRV in the samples, and they can detect it at consistent rates with blinded samples, then that's the only result he needs. And I imagine that a generous margin of error will be allowed for the initial study, so they won't have to be 100% correct for all the blinded samples.
Lipkin, on his way to Vietnam for a conference on emerging infections, tells the Health Blog that in addition to different definitions of CFS, possible explanations for the conflicting findings include the way labs process the blood samples or the tests they use.
The new study, Lipkin says, will involve fresh blood samples from 100 CFS patients and 100 similar, but healthy people — 25 of each group from four different sites around the country, to provide geographic diversity. The samples will be processed, blinded and sent to the FDA, the CDC and the Whittemore Peterson Institute, which led the team that published the original Science paper. If a lab finds a sample is positive for XMRV, further tests will be needed to confirm the result.
If one lab finds a positive sample but another lab doesn’t, the same samples can be shipped again, with a new blinded code, to be tested again. “If you get the same result, it is valid,” Lipkin says.
He adds that it may turn out that certain labs are simply more proficient than others at finding XMRV and related viruses. And he says he’s open to whatever the outcome is, which is one reason why NIAID asked his group to run the study. “We have no horse in this race,” he says.
http://blogs.wsj.com/health/2010/09...atest-xmrv-study/?KEYWORDS=amy+dockser+marcus
And I also read that the patients he is using will fit the Canadian consensus criteria, and the patients would have to have had sore throats or tender lymph nodes when they got ill (I'm not clear about the details here, but I think that Judy basically insisted that the patients have what we recognise as definite ME, and not another type of fatiguing illness.)
Ah, I've found the quotes:
...the study will seek to enroll people who in addition to
meeting criteria for two widely used, symptom-based definitions of CFS, showed
signs of infection — such as a sore throat or tender lymph nodes — around the time they developed CFS. The thought is that if there is a viral link to CFS, it’s most likely to show up in those patients.
http://blogs.wsj.com/health/2010/11...-search-for-xmrv/?KEYWORDS=amy+dockser+marcus
And here's the other source of info that I was looking for...
It's one of Cort's recent 'XMRV Buzz' entries...
Nov 18th
Amy Dockser Marcus recently told us that Dr. Lipkin called together representatives to discuss his study about 2 weeks ago. Now we're getting a few telling details - or rather we can infer a few telling details. She notes that clinicians from Miami, Boston, Palo Alto and Salt Lake City will be involved
which can only translate to four of our top physicians: Dr. Klimas, Dr. Komarroff, Dr. Montoya and Dr. Bateman. (Do you think they know a person with CFS when they see one?)
Dr. Lipkin will be taking a broad sweep of the viruses - looking for XMRV and all over viruses in the same family. Patients will have to meet two criteria, which given the physicians involved,
can only mean the Fukuda AND the Canadian Criteria PLUS they will have to have infectious onset which means the patient cohort will closely duplicate the original patient cohort in the Science study - which is, of course, what we want. Three labs will test the blood -the WPI, the FDA/NIH (Alter/Lo) and the CDC.
ME/CFS experts providing 'good' ME/CFS patients and using two of the only labs to actually find XMRV? This looks like an excellent study.
http://aboutmecfs.org/Rsrch/XMRVBuzz.aspx
http://blogs.wsj.com/health/2010/11...-search-for-xmrv/?KEYWORDS=amy+dockser+marcus
I also thought that I'd read that Lipkin will be using samples from Cheney's and Bell's patients, but I can't find a quote for that, and I'm not 100% sure that I did read it... If I find the quote, I'll post it here.
Blood Working Group
I think that the blood working group is carrying out similar, and even more thorough work than Lipkin, and they intend to do it on a larger scale...
And remember that the BWG is well past it's initial phase now... They've already detected XMRV in phase I, and they couldn't have done this if XMRV does not exist or if it's just a fantasy rumour virus... From the quote below ("All the labs were able to detect at least some amount of XMRV"), it seems evident that the researchers involved in the BWG
know that this is a real virus they are dealing with.
The quotes, below, also show how the WPI are intrinsically involved with the BWG, and show how reasuringly thorough the BWG research is.
In this phase, six labs — two from FDA plus labs at the NCI, the CDC, the Blood Systems Research Institute and the Whittemore-Peterson Institute — used a panel of blood samples spiked with different amounts of XMRV to establish if the labs’ tests are sensitive and reliable enough to detect the virus in blood. They are.
All the labs were able to detect at least some amount of XMRV. (Some of the labs have been involved in the dueling research on a link between the virus and CFS.)
The presentation — which the Health Blog previewed ahead of the meeting — suggests that the first phase of the study has some limits. As researchers continue to study XMRV,
there is a growing sense that virus taken from patients may be different than the virus the labs studied. That’s why, researchers say, it’s important to start looking at what’s going on in actual people.
That will happen in future phases of the working group’s investigation.
In a pilot study of the second phase, WPI collected blood from four CFS patients they had found to be XMRV-positive and sent the samples to CDC and NCI for testing. Results are expected soon.
In the third phase, WPI will collect 25 samples from XMRV-positive CFS patients and send them — as well as XMRV-negative samples from healthy people — to all the other labs for testing.
Phase four will analyze blood from 300 blood donors, 25 confirmed XMRV-positive patients, and 30 XMRV-negative samples from 10 independent blood donors. This data will finally get researchers a little closer to answering at least one of the key questions in the still-unfolding drama: Is XMRV widespread in the nation’s blood supply?
http://blogs.wsj.com/health/2010/07...e-to-hear-about-xmrv-working-groups-research/
...the Blood XMRV Scientific Research Working Group is taking a three-stage approach to its handling of the issues related to XMRV and the possible link to human disease. The first stage will be to standardize and validate laboratory methods and reagents for XMRV testing. This is important since variations in sample collection and laboratory procedures can produce discrepant results. These standardized approaches will be used initially to test 1,200 healthy donors’ blood samples
and 100 CFS patients’ blood samples collected by Dr. Judy Mikovits of the Whittemore Peterson Institute. Stage two will assess the prevalence of XMRV in the general population and blood supply, as well as in other CFS patient cohorts. The third stage will be a series of studies to
understand how XMRV is transmitted, whether it causes human disease, and how it affects various subgroups of the population.
http://www.cfids.org/cfidslink/2009/120203.asp
According to CDC, their studies using samples obtained from the Whittemore Peterson Institute have HHS attention. The Laboratory Branch in CDC’s Division of HIV/AIDS Prevention is doing the XMRV testing and not the CDC CFS research group in the Division of Viral and Rickettsial Diseases.
http://www.cfids.org/cfidslink/2009/120203.asp
