Update on CFI (Chronic Fatigue Initiative)/Lipkin patient samples from Nancy Klimas

[oceanblue]

I think there's a lot of confusion about how the patient samples being collected for the Lipkin XMRV study relate to the similar set of samples being collected by the CFI and which will be used by Lipkin and colleagues for pathogen discovery. This comment posted by Nancy Klimas on 16 Jan on the Research1st website might help clarify things:

...The CAA biobank work is very important, and excellent scientists are using this valuable resource to study ME/CFS. I would make one small correction the Lipkin study will use the CFI biobank samples, not the XMRV/MLV study samples. Ian Lipkins role in the XMRV/MLV study has been to organize the whole thing, and coordinate the collection and processing of samples that are sent out to the scientists running the blinded samples in various MLV and/or XMRV assays. In the end there are no samples left at Columbia for future studies. Any participant will know that we drew a lot of blood to allow enough samples to go out to so many research laboratories, not enough to let the Columbia group have at it as well. Thats okay, because the Columbia group is also working with the Chronic Fatigue Initiative (CFI) whose mission includes pathogen discovery and biomarker discovery. To that end CFI is working with 5 sites and recruiting many of the same subjects as well as others to create an even larger number of patients and controls (200 patients and 200 matched healthy controls). These samples will be used by the Columbia group, with Mady Hornig, David Hirschberg and Ian Lipkin using the latest technology to look at blood, saliva, tears and stool samples for pathogens as well as biomarkers. Other scientists will also have the opportunity to use this biobank to do important work, whether it is new or validation of promising work coming from other studies (such as the biomarker discovery work in the CAA initiative).

 

[Ember]

I think there's a lot of confusion about how the patient samples being collected for the Lipkin XMRV study relate to the similar set of samples being collected by the CFI and which will be used by Lipkin and colleagues for pathogen discovery.

Of interest here may be Ian Lipkin's comments on these cohorts. He's been quoted concerning the Lipkin/Hornig study:

The key to maximizing the outcomes of these tests is the criteria of the patients selected, according to Dr. Lipkin. He said this will give the greatest possibility of finding objective measures for monitoring and measuring the disease. University of Miami researcher and physician Dr. Nancy Klimas, who has been involved in several clinical definitions of ME/CFS, is in charge of the cohort recruitment to draw 200 patients from five sites located throughout the U.S.

What we want to do is start with patients who have been characterized extensively using standardized criteria established by a group of widely respected clinical researchers, said Dr. Lipkin (http://trialx.com/curetalk/2011/11/...equencing-and-proteomics-to-hunt-cfs-viruses/).

Amy Dockser Marcus quotes him concerning the XMRV study:

As a starting point, everyone had to agree on how to define a CFS patient for the purposes of the study. The issue has been highly contentious and Lipkin says they tried to agree to criteria for patient selection that includes everyones viewpoints.

The solution: 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, its most likely to show up in those patients (http://blogs.wsj.com/health/2010/11/17/gearing-up-for-the-big-search-for-xmrv/).

 

[Desdinova]

Lipkin says they tried to agree to criteria for patient selection that includes everyones viewpoints.

Everyones viewpoints? Now do we know who 100% is having their viewpoints included? Do we know for a fact that it isn't anyone besides the key researchers? Or has (someone or some individuals from) the NIH or CDC had a say in things?

 

[Ember]

Now do we know who 100% is having their viewpoints included? Do we know for a fact that it isn't anyone besides the key researchers? Or has (someone or some individuals from) the NIH or CDC had a say in things?

In any case, it seems clear to me from Ian Lipkin's comments that they're using the CCC (with or without Fukuda) and adding in signs of infection at onset in the case of the XMRV study. That seems to be the end result of including everyone's viewpoints, and it's the end result that ultimately matters to us.