Phoenix Rising - Cort Johnson's Column
...Presenting complex chronic fatigue syndrome (ME/CFS) research in a way we can all understand.
Thursday, July 7th, 2011:
Let the Games Begin: Dr Cheney Reports Lipkin XMRV CFS Study to Begin
Dr. Ronald Glaser - Chronic Fatigue Syndrome and the Pathophysiology of EBV Infection
by Cort Johnson
Dr. Cheney was an enthusiastic supporter of the XMRV finding early on; he did a webcast on it and several blogs, suggested treatments and provided patients for the WPI to study. In this post from Jan Van Roijen on Co-cure Dr. Cheney reveals the latest on the Lipkin study from a conference call with Dr. Lipkin.
The fact that he – an important ME/CFS physician and thinker – who is not involved with the trials, was on the conference call demonstrates Dr. Lipkin’s commitment to get many of the major elements of the CFS community involved.
What did we learn? The Lipkin study has not officially ‘begun’; ie it has not started collecting samples but is about to, and yes, Dr. Lipkin does expect it to finish up by early next year or sooner (cross your fingers :) ).
The study has been expanded since Sept of 2010 when Dr. Lipkin envisioned 100 patients collected from four sites. Now 150 patients will come from six sites (25 patients per site).
Six physicians (Drs. Montoya, Komarroff, Klimas, Enlander (?), Peterson and Bateman) will be providing a total of 150 patient samples to go with the 150 control samples. All the samples will be collected and stored in the same manner. All the reagents used will be tested for contamination.
Each lab will take its own shot at the virus. The WPI will take the strongest shot employing 4 different tests; culture, PCR, western blot with sequencing and serology, Alter/Lo will do PCR on plasma and Switzer will use PCR on extracted DNA.
In these types of studies an independent agent usually stores the codes for the samples. After all the parties report their results the code for each sample will be broken and the researchers will learn what percentage of CFS patients and healthy controls their tests indicated were positives and if any other labs had similar results.
The goal for the WPI will be to find low levels of XMRV in healthy controls (<10%) and find significantly higher levels of XMRV in the patient samples.
Good News For The WPI - The fact that Lipkin will count ANY positive as a positive for each sample is helpful for the WPI since they will be taking the most shots (four) at each sample. Since any positive counts as positive all they have to do is find the bug once out of four times in order for that sample to count as ‘positive’.
Lowering the bar for what is positive (ie multiple positives are not required for a sample to be positive) does bring a danger of false positives as well.
Since the investigators are looking for MLV’s and XMRV there will presumably be two separate sets of results; one for XMRV positives and one for MLV positives.
We can assume that the CDC findings will be negative. If Alter/Lo are using the same methodology as they did in their first study, the best guess is that they will find MLV’s but probably not XMRV.
The most important lab, of course, is the WPI. It doesn’t really matter what the other labs find so long as the samples the WPI finds XMRV in end up mostly belonging to people with CFS and not the healthy controls. If that happens then they’ve proven that they and no one else thus far, knows how to find XMRV and the whole process presumably starts over again, this time with labs using exactly the same methods as the WPI.
Dr. Cheney concluded that Dr. Lipkin is acting in a non-partisan manner and he is fully confident that Dr. Mikovits will turn the tables on much of the rest of the medical establishment stating he:
"would not want to be Switzer or the CDC or Jay Levy or Singh or John Coffin or the Science editors or most of the UK medical establishment right now. The odds are not in their favor but we will see. I think they are all on the Titanic after what I heard today."
Let the Games Begin….
The entire post is below:
‘I and a few other colleagues just completed a large conference call with NIH officials and many interested parties regarding the proposed *Lipkin* study which is poised to soon be launched.
Results are expected by early next year or sooner on 150 CFS cases and 150 matched controls from six centers familiar with CFS (Stanford U., Harvard U., U. Miami, NYC, Incline Village and Salt Lake City).These cases are from three academic centers and three private practices who see CFS cases.
The study, independently agreed upon by three XMRV investigators (WPI-Mikovits, FDA-Lo/Alter and CDC-Switzer), and overseen by Ian Lipkin himself at the NIH will resolve the current disagreements on:
a) the existence of detectable XMRV/MLV in CFS
b) the association of XMRV/MLV with CFS.
After listening to about 20 key players on three continents as well as Lipkin himself who appears very non-partisan, there is no doubt in my mind what this study will show with the full backing of the NIH in its outcome and conclusions.
The good thing will be that all reagents will be certified as contaminant free.
All samples will be collected the same way and cases/controls assessed the same way.
In the analysis, though different labs will do *their thing*, they are allowed the methods they choose.
If a sample is positive from any of the three, it will be counted positive and if any sample is negative from all three, it will be counted as negative.
If one sample is positive from one site and negative from the other two, it will be deemed positive for purposes of the study conclusions.
Judy Mikovits will employ four different assays (culture, PCR, western blot with sequencing and serology) while Alter/Lo will employ PCR on plasma and Switzer will use PCR on extracted DNA as sole tests.
May the games begin and the best man or woman win.
If Judy Mikovits can, in a blinded fashion, come to the same conclusions she arrived at before in the Science paper, the sky will fall in on all other naysayers and reputations and egos will suffer great humiliation.
I am confident she will do well and so is she.
If not, the patients are no worse off than before and this disease will remain the enigma it has always been to those who treat it and those who live it.
However, I would not want to be Switzer or the CDC or Jay Levy or Singh or John Coffin or the Science editors or most of the UK medical establishment right now.
The odds are not in their favor but we will see. I think they are all on the Titanic after what I heard today.’
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