BWG Phase Two Results - Webinar

jspotila

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The CFIDS Association will host a webinar on Friday, December 17th at 1pm EST during which Dr. Graham Simmons and Dr. Michael Busch will provide an update on Working Group, including results from Phase II. The Association believes the patient community should have the chance to hear the BWG report live, and so arranged this webinar because while the FDA Blood Products meeting is open to the public, it will not be webcast. You can register for this webinar here: https://www1.gotomeeting.com/register/985931313

Here is the full description from the webinar page:

The Department of Health and Human Services Blood XMRV Scientific Research Working Group (SRWG) was established in late 2009 to design and coordinate research studies to evaluate whether XMRV poses a threat to blood safety. It is presently overseeing a four-phase study with the following objectives:

* Phase I: Evaluating the analytical sensitivity of multiple XMRV nucleic acid assays

* Phase II: Pilot clinical studies to evaluate optimal processing time and sample preparation

* Phase III: Evaluating clinical sensitivity and specificity of XMRV nucleic acid and antibody assays

* Phase IV: Initial estimation of the proportion of blood donors who are positive for XMRV nucleic acids and/or antibodies.

Results of the Phase I (analytical panels) were presented on July 27, 2010 at a meeting of the FDAs Blood Products Advisory Committee (BPAC). Results of Phase II (pilot clinical studies) will be presented on Dec. 14, 2010 to the BPAC. An agenda for the BPAC meeting can be found at http://bit.ly/ho5Aw4. BPAC meetings are open to the public, but are not available by webcast.

In this webinar, Graham Simmons, PhD, and Michael Busch, MD, PhD, of Blood Systems Research Institute and University of California-San Francisco will provide an update on the Blood XMRV Scientific Research Working Group studies, including results from Phase II, as well as future retrospective repository and prospective screening studies of XMRV in US blood donors and recipients. Steven H. Kleinman, BSc, MD, of University of British Columbia, and a member of the SRWG, will serve as moderator for the discussion.

The webinar is hosted by the CFIDS Association of America as part of its 2010 Webinar Series.
 

Esther12

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Thanks for that jspotila.

Any sneaky hints about what we should expect? Do the WPI know the results yet? So eager...
 

Cort

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I think but, of course, don't know, that Judy must know the results....which makes it interesting that she is branching out further - talking about XMRV's relationship with Lyme, atypical MS in about a month in Santa Rose....can one assume that whatever the news is, it is not bad? I think we could say that if she does know - then we don't have a disaster waiting for us....

I do hope they have gotten to the bottom of something......maybe I'm a little bit jaded but I do leave open the possibility that they have found no contamination, no discerning sample preparation problems and therefore just aren't sure what is going on.....
 

CBS

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Jennie,

Thank you for posting this and thanks to the CAA for arranging/hosting this webinar. This is the type of information that the patient community needs.

I know. But wasn't it all blinded? I just wondered if the WPI had been told the results once everything had been unblinded.
Hi Esther, Just a quick question/comment. When you ask if "it" (assuming that you are referring to phase 2 of the BWG study) was "blinded," are referring to the act of "blinding" the researcher to the patient/control status of samples they are testing until after they have analyzed the samples and declared them positive or negative? Or are you using the term "blinded' to refer to the conclusions of the second phase and the results of the other labs? The term "blinded" typically refers to the former.
 

Esther12

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Thanks again jspotila. I was just hoping you'd have some more insider knowledge.

The term "blinded" typically refers to the former.
Yup. That's what I meant too. I'm not sure at what point the labs involved would have been told which samples were from CFS patients and which were from controls - maybe not yet?
 

Cort

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My take on the XMRV Buzz Page

Phase II of BWG Study is Complete (Really!) - The CFIDS Association today announced that the oh so important (and time consuming) second section of the BWGs study focusing on sample preparation and sample storage is complete and that the results will be announced at the BWGs meeting, just 3 days from now (Dec 14th) (gulp). The meeting is open to the public (if you happen to be in Gaithersburg, MD) but is not webcast; just three days later, though, a CFIDS Association webinar (register here) will feature two members of the BWG who will talk about the results and where they go from here.

Dr LeGrice reported they were looking at contamination issues although that has never been explicitly stated. Still, if contamination was to occur it would presumably occur during the sample preparation phase. At the very least the Group should be able to tell us how to prepare and store an XMRV sample such that it does not disappear. This suggests they should be able to indirectly tell us if any studies inadvertently destroyed XMRV during the sample preparation/storage phase.

Meeting Agenda - XMRV and the MLVs will be the second topic on the meeting agenda. That discussion will take place from 1-3:30 pm EST. There will be nine presentations; Dr. Mikovits will make one of them. Here they are:

A. Introduction and Background, Indira Hewlett, Ph.D., DETTD, OBRR, FDA (10)
B. Summary of Current Research on MLV-related Human Retroviruses and Disease Association, Jonathan Stoye, Ph.D., NIMR, UK ( 25)
C. Recent Studies of Epidemiology of MLV-related Human Retroviruses:

i. U.S. Study, Shyh-Ching Lo, M.D., OCTGT, FDA (15)
ii. U.S. Study. Maureen Hanson, Ph.D., Cornell University (15)
iii. UK Study, Judy Mikovits, Ph.D. Whitmore Peterson Institute (15)

D. Animal Studies: Potential Transfusion Transmission of MLV-related Human Retroviruses, Francois Villinger, Emory University (20)
E. Update of Blood XMRV Working Group Activities, Graham Simmons, Ph.D., BSRI (15)
F. Prospective and Retrospective U.S. Donor Surveillance Studies, Michael Busch, M.D., Ph.D., Blood Systems Research Institute (15)
G. Assay Development Efforts on MLV-related Human Retroviruses, Rachel Bagni, Ph.D., National Cancer Institute (20)
 

Otis

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Just a bit more jaded

I think but, of course, don't know, that Judy must know the results....which makes it interesting that she is branching out further - talking about XMRV's relationship with Lyme, atypical MS in about a month in Santa Rose....can one assume that whatever the news is, it is not bad? I think we could say that if she does know - then we don't have a disaster waiting for us....

I do hope they have gotten to the bottom of something......maybe I'm a little bit jaded but I do leave open the possibility that they have found no contamination, no discerning sample preparation problems and therefore just aren't sure what is going on.....
Having established myself as 'slightly' more jaded, ;)

In my mind at this point, the question is: "Do we still have to listen 'rumor contamination' any longer, or not"? Be specific or shut uppa you face.
 

Hope123

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I think that this broadcast will hopefully answer some questions. It think it's a good sign that Dennis Mangan just released recent info for the NIH conference this week; it's possible they found something that prompted them to set a concrete date for the conference although the conference (without a specific date) had been mentioned earlier during CFSAC without regard to the BWG results.
 

free at last

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Seems striking to me that Judy, is going to be talking about there positive uk study.If she has found out there was major problems uncovered during the phase 2 studys.Then that would seem a rather silly presentation from the outset.Either she doesnt know the conclusions of phase 2. or this indeed is a indication, everything is still on track. I cant help thinking even if she didnt know the conclusions of phase 2.Just to be playing it safe a positive uk 50 presentation would be the last thing she would be doing under those uncertain circumstances from her and the wpi.I think she knows. And i think its full steam ahead.Am i wrong to be assuming this ? Anyone
 

Esther12

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Am i wrong to be assuming this ? Anyone
I think you're probably right... but as a note of caution: Judy and the WPI have always been very confident. It's not impossible that they don't know the results, but really don't think they could possibly be wrong about this. Even more unlikey - they could be pushing ahead even if the BWG results threw doubt on their work.
 

Cort

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Seems striking to me that Judy, is going to be talking about there positive uk study.If she has found out there was major problems uncovered during the phase 2 studys.Then that would seem a rather silly presentation from the outset.Either she doesnt know the conclusions of phase 2. or this indeed is a indication, everything is still on track. I cant help thinking even if she didnt know the conclusions of phase 2.Just to be playing it safe a positive uk 50 presentation would be the last thing she would be doing under those uncertain circumstances from her and the wpi.I think she knows. And i think its full steam ahead.Am i wrong to be assuming this ? Anyone
That all makes sense to me :)
 

Mark

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I'm getting so nervous about this now - it really seems to be set up as a make-or-break for us - but I have to recognise what Cort said: the evidence of how everything has unfolded so far suggests we're just as likely to get another inconclusive and confusing set of findings.

Since the results are going to be public domain on Tuesday, I hope we won't have to wait until Friday for the headlines. One part of what's supposed to be coming this week seems fundamental: the WPI results. So long as they have decently consistent figures for their blinded tests, there should be nothing else to discuss: I want to see those numbers on Tuesday. And one part that troubles me is that the results I'm hoping to see on Tuesday ought to see the world's media beating down their doors that night...in which case Friday's webinar from the CAA would be rather redundant. Can we conclude from the existence of that webinar, 3 days after the news breaks, that whatever is about to be unveiled is not going to set the world alight?...

I've made the point often enough, as have plenty of others, so I'll only briefly mention now that the lack of transparency from the BWG has lost the trust and respect of significant sections of the patient community, including myself, such that the group now lacks the authority to deliver a 'negative' result this week without spawning a thousand new conspiracy theories. We just have to hope that scenario isn't going to arise...

Anyway, we shall soon see. I agree with all the points made above that suggest the WPI are still backing their findings, and I would add that it's inconceivable to me to imagine that the unblinding would all happen and be revealed to the participating groups, at the meeting itself, this week - surely the results must be known to the WPI by now? - and they don't seem to be slowing down. Surely the unblinding process would be only the start of the work needed before next Tuesday: they then need to present those results, and come to some interpretation as to their meaning. It seems to me that's probably what they've been doing for the last month.

But I'm not making myself any less nervous here...could we be 'free at last' in 48 hours time? Whatever happens, I'm glad I'll have the Phoenix Rising community to share the moment with...
 

Esther12

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Since the results are going to be public domain on Tuesday
?

Are they? I missed that.

As for a BWG negative spawning conspiracy theories... we'll have to wait and see. If the WPI accept the BWG's verdict, I don't think many patients will go on insisting otherwise. It sounds like stuff like the Singh study is ongoing anyway - I think we're going to get a pretty conclusive answer on this one.