BWG Phase Two Results - Webinar

[Anika]

How "pedigreed" can a negative control person be?

Working through the slides, I'm still a bit puzzled by the labelling of "false positives" occurring on the "pedigreed negative" in Phase 2b. , and by the whole concept of a "pedigreed negative" person.

Does anyone know exactly how the person who was used as the "pedigreed negative" control came about that pedigree? Were multiple samples over time by multiple labs all in agreement that there were no signs of positivity?

Even assuming that to be the case....if even an agreed "positive" person can test negative on multiple occasions, how sure can you ever be that a person with multiple negative results is indeed negative (especially without doing tests of possible tissue reservoirs)? And that also assumes no intervening source of infection.

So, it seems to me one has to make two kinds of assumptions on a "pedigreed negative" person...but I could be missing something. If this is true, I think it's the type of thing that needs to be noted in an analysis. The slides simply treat the positive results as false positives without qualification.

Yes, they did address a procedural explanation for a possible false positive on the WPI's test, but I didn't see how that actually "verified" that the positive was false. I also didn't note any explanation of why NCI also had a positive result. So, I wouldn't treat the negative as "pedigreed" any more.

Without knowing more, if I had been doing the slides, I would have avoided the term "pedigreed" altogether, especially for the negative / control. And I would have qualified the reference to "false positives" as being only "presumptively" so, or qualified in some way.

 

[mojoey]

I completely agree with this. I am all for donating to the WPI, but the major risk to patients donating 100% of their discretionary funds to them is: what if they can't use it in an optimal way? I think they should be first in line for extra federal fundings, especially for clinical trials, but what if they continue to (if hearsay is fact) get blackballed and blacklisted? Then wouldn't it be in the best interests of ourselves and the long-term viability of WPI try to also fund independent researchers whom are also interested in studying XMRV such as Stefanos Sarafianos and Ila Singh to spread out our risk and also try to replicate the WPI's findings as Dr. Enlander has talked about doing with a 5-independent-lab blinded study?

That's why i think it's better to fund research through a CFS org (if there is a good one) than as individuals. An organization can have much more control about what the funds are used for, can demand more insight, etc. I have no idea about the budget and financial situation of the WPI or other institutions, what it costs them to do what they are doing, and so on. Such things would be interesting to know, to see where the money is needed most. We (the people with CFS) should have more control, try to take matters into our own hands more.

 

[jspotila]

Does anyone know exactly how the person who was used as the "pedigreed negative" control came about that pedigree? Were multiple samples over time by multiple labs all in agreement that there were no signs of positivity?

I believe Dr. Simmons said that the negative control had tested negative multiple times, multiple labs. I don't have my notes in front of me, but that's my recollection.

 

[alex3619]

The only problem i have is that it might easily take another 4 months for phase III to complete . It's very frustrating and hard to bear how slow everything is moving.

Hi eric_s, I think it was said in the webinar that phase 3 starts in January and may take six months. Bye, Alex

 

[SOC]

I believe Dr. Simmons said that the negative control had tested negative multiple times, multiple labs. I don't have my notes in front of me, but that's my recollection.

Yup, that's what he said. So it's very, very likely to be negative, but far from certainly negative -- probably the best they can do at the moment.

 

[SOC]

Since I was one of those complaining about using only 5 samples, I thought I'd better share what I realized this morning when I was complaining about it to my family.

They bled 5 patients, but tested plasma, whole blood, (and PBMCs?). That's 10 (or 15) tests to run. Then, they used multiple methods (3 or 4?). And then there were multiple days of storage.... I don't have the slides, but we could figure out the exact numbers. In any case, it's a substantial number of tests. Each lab must have done at least 30 tests, and probably a lot more.

Or am I totally messing up here?

Anyone here expert at statistical design of experiements? Maybe more info could be extracted from the set of tests...? Or maybe that's useless with yes-no data.....

 

[Tuha]

I completely agree with this. I am all for donating to the WPI, but the major risk to patients donating 100% of their discretionary funds to them is: what if they can't use it in an optimal way? I think they should be first in line for extra federal fundings, especially for clinical trials, but what if they continue to (if hearsay is fact) get blackballed and blacklisted? Then wouldn't it be in the best interests of ourselves and the long-term viability of WPI try to also fund independent researchers whom are also interested in studying XMRV such as Stefanos Sarafianos and Ila Singh to spread out our risk and also try to replicate the WPI's findings as Dr. Enlander has talked about doing with a 5-independent-lab blinded study?

I also agree with this. WPI is very important but they cannot do all work - then it will take much longer to get some results. On the end of the year I want to donate to some CFS research organisations and some patients advocacy groups but I know just WPI, MCWPA, ESME, CAA. I would also like to support other researchers like maybe Bell, Lerner, Meirleir, Cheney,........but I dont know at all how can I do it. if they do some research projects,.... Maybe it would be also good to have a list with Cfs research/patients organisations and how can you donate or support them. Then we could do publicity for their projects.

 

[eric_s]

That's a good idea Tuha. If we don't have that yet i will try to copmile such a list. Unless someone else does it first. Feel free...

 

[eric_s]

Hi eric_s, I think it was said in the webinar that phase 3 starts in January and may take six months. Bye, Alex

Hi Alex

I also got my info from the webinar, but for whatever reason i understood 3 months. Now, i tried to go back and find that passage in the webinar.

At 26:47 Dr. Busch says that they are probably at least 6 months away from completion of phase III and IV, the way i understand him. So as far as i'm concerned, i don't have any indication when phase III will be completed.

What do you think? Do you have any other info than that sequence of the webinar?
If anyone has information about the estimated date for completion of phase III, please post.

 

[alex3619]

Hi eric_s, I don't have anything other than the webinar, but at another point he did say they were drawing blood for phase 3 in January. Given that its almost Xmas this is about as soon as they can organize it. Bye, Alex

 

[urbantravels]

I also agree with this. WPI is very important but they cannot do all work - then it will take much longer to get some results. On the end of the year I want to donate to some CFS research organisations and some patients advocacy groups but I know just WPI, MCWPA, ESME, CAA. I would also like to support other researchers like maybe Bell, Lerner, Meirleir, Cheney,........but I dont know at all how can I do it. if they do some research projects,.... Maybe it would be also good to have a list with Cfs research/patients organisations and how can you donate or support them. Then we could do publicity for their projects.

I asked this question in a thread some time ago and got some very good replies.

http://forums.aboutmecfs.org/showthread.php?8185-to-support-research-NOW

There are direct links to support both Nancy Klimas (via the University of Miami) and Ila Singh/Lucinda Bateman (through OFFER Utah.)

I just had my birthday and set up a Causes.com birthday wish on Facebook. I originally wanted the donations to go to Nancy Klimas, and even set up a new "cause" to do this, but after all this work it turns out Causes.com does not have the ability to designate funds to a particular purpose within a nonprofit - all they would do is cut a check at the end of the month to the University of Miami as a whole, including the money from everyone who chose University of Miami as a beneficiary of their cause. Not at all what I had in mind. So I chose the CAA's SolveCFS research fund as the "cause" instead, figuring that from there money would fall into the pockets of multiple worthy research efforts. (Causes.com was kind of buggy and a lot of my friends didn't want to use it because it would plunder too much of their personal info, but I also provided a link directly to solvecfs.org for people to donate directly.)

 

[Cort]

This is the main issue. WPI lack funds, and since they are a key part of this whole thing, everything is proceeding much slower than it otherwise could. This in turn is leading to the delay in publishing papers (journals are reluctant to publish), which in turn is leading to the lack of funds. It's a real catch-22.

Note to ME/CFS patients: The only way to speed things up is to fund the WPI, and to advocate vigorously for the WPI to be funded from government agencies.

I agree the most important thing is for the WPI to get the funding it needs. I can only imagine its been a very stressful year financially for them. They do have money from the tests coming in but they have alot more needs as well - projects they and we want to get done (those unsequenced isolates come to mind).

The WPI is working on so many things...They've been working on that big UK study with the NCI, they are working with the NCI to develop standardized reagent and primers (I imagine that is actually the most important project right now), Dr. Mikovits is writing grants and papers, advising projects how to do the studies, they are testing out their isolates and god knows what else. They may believe other projects will better fulfill their needs and I'm sure that they are absolutely slammed with work.

If they had more money they could hire more people and get stuff done faster......

 

[omerbasket]

I agree the most important thing is for the WPI to get the funding it needs. I can only imagine its been a very stressful year financially for them. They do have money from the tests coming in but they have alot more needs as well - projects they and we want to get done (those unsequenced isolates come to mind).

The WPI is working on so many things...They've been working on that big UK study with the NCI, they are working with the NCI to develop standardized reagent and primers (I imagine that is actually the most important project right now), Dr. Mikovits is writing grants and papers, advising projects how to do the studies, they are testing out their isolates and god knows what else. They may believe other projects will better fulfill their needs and I'm sure that they are absolutely slammed with work.

If they had more money they could hire more people and get stuff done faster......

I agree with you Cort, the WPI has so much things it does right now. They are loaded with work. However, they does not appear to giver up on big things, they are there when we need them.
They are angels.

 

[eric_s]

I also agree with this. WPI is very important but they cannot do all work - then it will take much longer to get some results. On the end of the year I want to donate to some CFS research organisations and some patients advocacy groups but I know just WPI, MCWPA, ESME, CAA. I would also like to support other researchers like maybe Bell, Lerner, Meirleir, Cheney,........but I dont know at all how can I do it. if they do some research projects,.... Maybe it would be also good to have a list with Cfs research/patients organisations and how can you donate or support them. Then we could do publicity for their projects.

Hi Tuha

Here are some potential recipients. I did not look for patient organisations or individual doctors or researchers, only organisations or institutions where you can donate to research. Before donating please check wheter they are still active, in some cases i'm not entirely sure. When i have some more time, i will try to extend my list. I want to get an overview of all the organisations.


IACFS/ME

ESME

Invest in ME

ME Research UK

ME Association (Ramsay Fund)

University of Miami Morton Fund (Dr. Nancy Klimas)

OFFER

CFIDS Association of America

National CFIDS Foundation

CFS Research Foundation (Dr. Jonathan Kerr)

Alison Hunter Memorial Foundation

P.A.N.D.O.R.A

WPI

 

[CBS]

Hi Tuha

Here are some potential recipients. I did not look for patient organisations or individual doctors or researchers, only organisations or institutions where you can donate to research. Before donating please check wheter they are still active, in some cases i'm not entirely sure. When i have some more time, i will try to extend my list. I want to get an overview of all the organisations.


...

OFFER

Eric,

Thanks for the list.

I would include Stanford Infectious Disease Department and Dr. Montoya (contact June P. Lang - 650-725-5524 or june.lang@stanford.edu). More details on their long and short term plans should be available very soon.

I did want to add that Dr. Bateman has said that if you were to donate to OFFERUtah (http://www.offerutah.org/donations.htm) and you specified that you wanted your donation to support the work of Drs. Alan & Kathy Light (doing fantastic work on post exercise up and down regulation of genetic markers for sensory, adrenergic and immune activation - think biomarlers) or Dr. Singh (looking at XMRV in a number of different ways) that OFFER would make sure that your wish was honored. Here is the link to OFFER's contact page if you wanted to call and request a specific use for your donation: http://www.offerutah.org/contact.htm

Dr. Bateman herself is working with Drs. Montoya, Klimas and Komaroff on the Lipkin study.

 

[jspotila]

A recording of the complete webinar is now available: http://www.youtube.com/watch?v=0HynlkG0cVc

Thanks to participant Ryan who made this screen-capture recording!