Dr. Craig: Now you bring up the
IOM report and one thing that I am interested to know regarding that, is that a new diagnostic criteria has been suggested. So how will this affect the Biobank and how you select patients for these studies? Do you plan to use the new diagnostic criteria or a combination of others that have already been used in the past?
Vernon: So what we have used was based on – so let me back up a little bit. The samples that exist in our Biobank, our current inventory, are still from the study that we did with GlaxoSmithKline in 2010. So we collected 340 I think, around there, samples from people that were diagnosed using the 1994 Fukuda criteria and the Canadian criteria by five ME/CFS expert clinicians including Dr. Nancy Klimas, Dr. Lucinda Bateman, Dan Peterson, Chuck Lapp and that’s it. That’s four right? Yeah that’s four. It is four, not five.
And so the partnership with GlaxoSmithKline (GSK) included working with these four clinical investigators so that they could do the diagnosing to make sure that the Biobank included samples from very well-characterized, clinically well-characterized ME/CFS patients and then that each of their patients were asked if they had a friend or a neighbor that they would help bring in to serve as a healthy control. So that’s how that whole initial inventory for that study was formed and it was effective.
And I mean what is remarkable is that from the blood samples that were collected from these patients and controls, after the GSK case study ended, we were left with a huge inventory of samples that were the components of these blood samples including plasma, cells that were frozen down and cryo-preserved again creating a very rich inventory for what we could do further research on. And they were attractive because the samples came from patients that were characterized by these ME/CFS clinical experts.
So as we go forward with the Biobank I think you may be aware that in November 2014, we were awarded a grant from
Falk Medical Trust, about a half $1 million grant that was intended to work with Dr. Lucinda Bateman again a clinical expert in ME/CFS medicine. And we are working with her to recruit a whole new cohort of ME/CFS patients and healthy controls to not only conduct an epigenetic study on these samples to extend
preliminary results from Dr. Patrick McGowan, but also to restock the Biobank with samples again from well-characterized patients and these patients will be enrolled using the 1994 and Canadian criteria again.
So when Dr. Bateman enrolls, these patients, she literally goes through a checklist for each of these criteria and the patients will have to meet both.
Now we are using the new IOM diagnostic criteria to form our questionnaires for this study. So we will ask specifically about post-exertional malaise in the study. We will ask specifically about function. We will ask about pain, we will ask about cognition and fatigue.
So the study will be based actually on the criteria from the IOM – we would basically collect the phenotype information based on the criteria recommended by the IOM. So instead of a bunch of long questionnaires that might not be relevant to ME/CFS really focus our questionnaires in a way that I don’t think would’ve been possible without having this IOM report in hand.
So it’s going to be really, really cool I think to say, “
Okay, here is patients that meets '94 and Canadian criteria,” and then, “
Here’s how they respond to these questionnaire” I think it’s going to really help us further see some of the strengths and limitations of the '94 and Canadian criteria as well as whether or not or how the IOM recommendations can be used in a research setting because they are diagnostic criteria. They were not formed for research studies. They are diagnostic criteria so I think it’s going to be real exciting to see how we can begin to shape these so that they do accelerate the way and improve the way we do ME/CFS research.
Dr. Craig: That sounds like a wonderful opportunity. Now you talked about the collection of blood samples. Is there any plan to collect any other types of samples; from stool or tissue?
Vernon: Not for this study. I think what we are going to do with this particular award is generate some deep rich data that helps inform the kinds of samples and the directions of research that should be taken in 2015.
