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Blood Products Advisory Committee Meeting Announcement (BPAC) December 14-15, 2010

Bob

Senior Member
Messages
16,455
Location
England (south coast)
Yes Cort all things that will need further investigation, and where are those assays ?
That last part Cort, surely figuring who was right and who was wrong would be half the reason to bother with such comparetive tests. yet no in depth analysis ( yet ) by them, very odd ? if the WPIs testing was shown to be highly suspect then that's something i feel would have been strongly highlighted, after all it was them that led to these tests in the first place.

Do we assume from that, the WPI and NCI got it right ? I hope these questions will be highlighted friday.If they are not, we need to be asking why. if the WPI and NCI, got this right but the CDC did not. could this be the reason for slience on this one.I note when the WPI got the pcr negative control wrong, that was mentioned fairly swiftly ? Are we seeing bias in analysis here. I hope not ?

Interesting about the NCI and WPI finding something in the negative control... We heard the same thing for the Phase I part of the study... What's interesting is who determined the negative samples in the first place? Surely it was the WPI, wasn't it? So if they have now detected XMRV, or similar, in one of the negative samples, then it's not a negative sample any more. It's now a positive sample. I want to know if the WPI and NCI detected something in the same 'negative' sample.

The BWG is a committee, and maybe that's why it's taking so long to get results. What I've heard about Lipkin, is that he will only require one group (i.e. the WPI) to detect XMRV. As long as the WPI's results are consistent in two different sets of same blinded samples, then that's all Lipkin says he needs to be satisfied.
 

Bob

Senior Member
Messages
16,455
Location
England (south coast)
(Total Side Note:Now what I really don't understand and maybe someone can enlighten me is what the he77 is Johathan Stoye doing sitting in on an purely American panel???? Does he hold any positions here in America??? I couldn't find any but ya know how that goes sometimes. Otherwise, no offense to our British Friends but WTF is a Brit doing advising an American Institution on a decision that affects only American blood donors??? It's very confusing.)

No offense taken! I totally agree... Get the damn Brit out of the BWG committee!
I don't understand what he's doing there either... He's supposed to work for the NIMR, an obscure UK research institution that none of us had heard of before Stoye and Bishop got involved with XMRV. It is the same Stoye, isn't it? So what on earth is he doing in the USA?
 

eric_s

Senior Member
Messages
1,925
Location
Switzerland/Spain (Valencia)
I find that a bit worrying that they have found a negative sample positive both in phases 1 and 2. Ok, they have provided some explanations, but nevertheless i would feel much better, if they had gotten all the samples right. On the other hand the UK study was blinded and so they have proven before that they can do it, even though there probably was a difference between sample storage and maybe preparation in that study. And Alter/Lo seem convinced, that makes me confident.

It was a bit hard from ValB's text to get the exact results from phase II, so i'm waiting for the webinar. But i would expect the WPI to be able to find the positives and have the negative negative, especially if they have provided those patients themselves.
 

Bob

Senior Member
Messages
16,455
Location
England (south coast)
I find that a bit worrying that they have found a negative sample positive both in phases 1 and 2. Ok, they have provided some explanations, but nevertheless i would feel much better, if they had gotten all the samples right. On the other hand the UK study was blinded and so they have proven before that they can do it, even though there probably was a difference between sample storage and maybe preparation in that study. And Alter/Lo seem convinced, that makes me confident.

It was a bit hard from ValB's text to get the exact results from phase II, so i'm waiting for the webinar. But i would expect the WPI to be able to find the positives and have the negative negative, especially if they have provided those patients themselves.

Can we expect the WPI to be 100% accurate at this early stage? They say that they expect detection rates to improve as the methodology improves and will continuously retest negative samples. Also, they might not claim that their specificity is 100%, but I don't know the details on their specificity.

Anyway, like you say, we really need the details of the results before we can draw any conclusions.

I'm interested in finding out what the WPI's and the NCI's serology results were. Val's text says that Judy said their serology results completely correlate, which would be a very significant result.
 
Messages
46
I have the hand-outs from the meeting and meant to post them so everyone has more details of which labs found what using which methods in which Phase IIa and IIb, but I did crash yesterday. Plus there are 6 slides on a page, so they're hard for my old eyes to read -- even with a magnifying glass -- and wouldn't survive scanning. I was hoping the FDA would post them immediately after the meeting. I'll try to get them posted up as soon as I can today. To me, they raise more questions than they answer, but I'll save that until I can them up where everyone see them. Apologies!
 

pictureofhealth

XMRV - L'Agent du Jour
Messages
534
Location
Europe
No offense taken! I totally agree... Get the damn Brit out of the BWG committee!
I don't understand what he's doing there either... He's supposed to work for the NIMR, an obscure UK research institution that none of us had heard of before Stoye and Bishop got involved with XMRV. It is the same Stoye, isn't it? So what on earth is he doing in the USA?

Jonathan Stoye has co authored papers on Murine Virology (in various shapes & forms) with John Coffin since at least 1985.

Perhaps Coffin is something of a mentor for Stoye? Perhaps Coffin invited him. Perhaps Stoye asked if he could come along?

See attached list:

http://www.biomedexperts.com/Profile.bme/1721844/Jonathan_Stoye
 

Bob

Senior Member
Messages
16,455
Location
England (south coast)
I have the hand-outs from the meeting and meant to post them so everyone has more details of which labs found what using which methods in which Phase IIa and IIb, but I did crash yesterday. Plus there are 6 slides on a page, so they're hard for my old eyes to read -- even with a magnifying glass -- and wouldn't survive scanning. I was hoping the FDA would post them immediately after the meeting. I'll try to get them posted up as soon as I can today. To me, they raise more questions than they answer, but I'll save that until I can them up where everyone see them. Apologies!

aw, Val, please don't apologise! you're an angel!
I'm not surprised you crashed! Your fingers must have ceased up with all that typing as well!
We're all really grateful to you... Big Big thanks! (I think George would say: Lots of big doggy licks!)
Yes, I know what you mean, the whole conference seems to have raised more questions than it answered!
Thanks again Val!
 
Messages
13,774
I have the hand-outs from the meeting and meant to post them so everyone has more details of which labs found what using which methods in which Phase IIa and IIb, but I did crash yesterday. Plus there are 6 slides on a page, so they're hard for my old eyes to read -- even with a magnifying glass -- and wouldn't survive scanning. I was hoping the FDA would post them immediately after the meeting. I'll try to get them posted up as soon as I can today. To me, they raise more questions than they answer, but I'll save that until I can them up where everyone see them. Apologies!

Thanks a lot Val.
 

Bob

Senior Member
Messages
16,455
Location
England (south coast)
I suppose we all need to wait for the webinar, but if Val and the PA's impressions are accurate, all I can say is that I'm stunned at the apparent lack of organisation on show here.

Given the issues at stake, that this is a Federal organisation (sic) and that this meeting was intended to bring clarity, there appeared to be :

No pre-arranged structure that would lead from discussion to a consensus to a summary to a decision (if possible);

Apparently no-one chairing the meeting to ensure that it proceeded as above an to objectively weigh up the evidence;

Apparently no prior knowledge that there were continuing ambiguities and that there was no consensus.

Instead it appears that entrenched interests were given floor time with no acknowledgement of the aims of the meeting - i.e. to make a recommendation to the FDA on blood safety.

Personally, if I were in charge, I would have reviewed the evidence in advance and noted the ongoing 'contraversy', cancelled the meeting until there was a clear agreed way forward, and in the interim strongly suggested to members of the advisory committee that they recommend a ban on the basis of the precautionary principle.

As it is, their soon to be public deliberations hardly inspire confidence although, on the other hand, if the meeting had been cancelled, I'm sure we would all be calling 'foul'.

Please, can someone wake me up when we get some real progress?:Retro mad:

Hi Marco,
I feel really dissapointed about the conclusions as well...
But, in case you didn't notice, the committee did actually recommend that the FDA excludes CFS patients from donating blood (Although it didn't seem it was heading that way from reading the text). So this is a result.

It's explained in Amy Dockser Marcus' blog:
http://online.wsj.com/article/SB100...321854485688.html?KEYWORDS=amy+dockser+marcus

The panel voted Tuesday 9 to 4 that the FDA should require a screening question to ask potential donors if they have a medical history of chronic fatigue syndrome and, if so, exclude them from donating.

Judy Mikovits, who led the team of researchers that published the study in Science linking XMRV to chronic fatigue syndrome, said Tuesday's decision is a victory for patients because "for the first time ever, they are being seen as sick with an infectious disease.''

I think this news kind of got buried a bit by the lack of clarity with the BWG Phase II results.
 

George

waitin' fer rabbits
Messages
853
Location
South Texas
Yep what Bob said Big doggy slurps and tail wags Val. If I had your picture you would go one the refrigerator of hero's.

Amen, this conference was just plain weird. There are so many questions at this point I'm not sure I can even remember them all. If Val gets the slides posted maybe it will help get a handle on them.

I know I will breath a lot easier when the FDA actually issues the ban. I hope they don't wait till next summer when they get all the new material printed and distributed. (grins) I do wonder if the Patient Advocate was right "Did they actually know what they ended up voting for??" (really big grins)
 

eric_s

Senior Member
Messages
1,925
Location
Switzerland/Spain (Valencia)
Can we expect the WPI to be 100% accurate at this early stage? They say that they expect detection rates to improve as the methodology improves and will continuously retest negative samples. Also, they might not claim that their specificity is 100%, but I don't know the details on their specificity.

Anyway, like you say, we really need the details of the results before we can draw any conclusions.

I'm interested in finding out what the WPI's and the NCI's serology results were. Val's text says that Judy said their serology results completely correlate, which would be a very significant result.
I don't think we can expect them to be 100% accurate, but to be honest i would expect them to not get a positive result from a negative sample and i would have expected a more accurate result than what i took from the transcript. But let's wait for the slides etc.

Lo for example said that they have tested hundreds of negatives with a negative result, so, yes, i don't like if the "manage":mask: to get the only negative one positive. But don't misunderstand me, i'm still positive about them and XMRV and i'll support them when i can. I just want more clarity and not in 5 years if possible :cool: And they have been working with XMRV for some years now, so i don't know if it really is such an early stage.
But anyway, like i said before, what i say is not meant to attack them, i just "demand" (not like anyone is listening to me at this moment :angel:) at least as high a standard from "our" side as from the other side, to make sure we are right.
 

eric_s

Senior Member
Messages
1,925
Location
Switzerland/Spain (Valencia)
U can't wait forever and I don't buy this that it takes years to prove anything.
If they have money, people, resources- it can be done fast.
Right, i totally agree. We will have to make sure they have that. Imagine if we could say "We have 20 million Euros. What can you do for us?". And then choose the best studies/projects. And tell them, "ok, you'll get it, but we would like to get a report every month, we want you to discuss your methods with the WPI and Alter/Lo and in the end we want a presentation and publication". Something like that...
 

George

waitin' fer rabbits
Messages
853
Location
South Texas
Also of interest there were no rebuttal testimony's. Only the positive testimonies were given. It seems like Stoyle was there to provide the dissent and Coffin was there to make it look rigorous, but nobody really took a good swipe at the results. And most of us saw the hand out that showed the numbers of positive versus negative studies that was part of the packet. The positives were actually skewed if they even found one positive even in Prostate Cancer.

Does anybody know if or who gave testimony on whether to ban Prostate Cancer patients???

I kinda though that the disorganization was a dog and pony show for a decision that was already in the bag.

As for the BWG information well, that's a horse of a different color I have no clue what that nuttiness is about?????
 

Bob

Senior Member
Messages
16,455
Location
England (south coast)
I hear what you're saying eric, but I'm not at all sure that one apparent false positive is significant. There maybe good reasons for it. It might not actually be a negative sample but instead it might have an extremely low copy number of XMRV that was previously undetected.
Interesting that both the WPI and the NCI (I think?) detected something in a negative sample. Was it the same sample? (And it's not clear exactly what they detected - was it a definite positive for XMRV?)
The CDC would not detect a positive in the supposedly negative sample because they can barely even detect positives in positive samples!
Anyway, I think I'm just trying to satisfy my own worries here!
 

eric_s

Senior Member
Messages
1,925
Location
Switzerland/Spain (Valencia)
I think we really have to wait until we see the material and maybe hear some more during the webinar. Also i hope there will be some good commentary by the CAA. The one they wrote after the XMRV workshop was pretty good, i think.
 
C

Cloud

Guest
I have the hand-outs from the meeting and meant to post them so everyone has more details of which labs found what using which methods in which Phase IIa and IIb, but I did crash yesterday. Plus there are 6 slides on a page, so they're hard for my old eyes to read -- even with a magnifying glass -- and wouldn't survive scanning. I was hoping the FDA would post them immediately after the meeting. I'll try to get them posted up as soon as I can today. To me, they raise more questions than they answer, but I'll save that until I can them up where everyone see them. Apologies!

Val, thanks so much for putting us front row for the meeting. The handouts will come ion handy too. Rest up and take care of yourself first. Your work is very appreciated.
 
C

Cloud

Guest
Even though OI is one of our worst symptoms, I doubt very many of us would consider the absence of that one symptom, "recovered". Regardless, apparently a significant group of people from that Bell cohort have reached a level of health they consider "recovered"......I would sure love it if we could get them on PR for a Q&A thread....any ideas?
 

Cort

Phoenix Rising Founder
I suppose we all need to wait for the webinar, but if Val and the PA's impressions are accurate, all I can say is that I'm stunned at the apparent lack of organisation on show here.

Given the issues at stake, that this is a Federal organisation (sic) and that this meeting was intended to bring clarity, there appeared to be :

No pre-arranged structure that would lead from discussion to a consensus to a summary to a decision (if possible);

Apparently no-one chairing the meeting to ensure that it proceeded as above an to objectively weigh up the evidence;

Apparently no prior knowledge that there were continuing ambiguities and that there was no consensus.

Instead it appears that entrenched interests were given floor time with no acknowledgement of the aims of the meeting - i.e. to make a recommendation to the FDA on blood safety.

Personally, if I were in charge, I would have reviewed the evidence in advance and noted the ongoing 'contraversy', cancelled the meeting until there was a clear agreed way forward, and in the interim strongly suggested to members of the advisory committee that they recommend a ban on the basis of the precautionary principle.

As it is, their soon to be public deliberations hardly inspire confidence although, on the other hand, if the meeting had been cancelled, I'm sure we would all be calling 'foul'.

Please, can someone wake me up when we get some real progress?:Retro mad:

Good points Marco! This is a pretty serious issue and if the PA is right and I'm sure he is then its kind of scary to think that XMRV is in the hands of this group.......Why did they send blinded samples to one group and not the other?? I'd really like to hear a reason why...there's gotta be a reason..... We don't need ad hoc - we need an organized efficient group.

Its possible though that they are impeccable scientists and just don't know how to function in a public function....altho they really - they should have been members of scads of committees before.
 
Messages
46
Marco,

They did have an agenda they followed that included discussion times. It just seemed to me that the BPAC members, other than Coffin and occasionally Klimas, didn't have much to say. I think Dr. Nelson, who asked the most questions, is also new, which may be why he asked so many and the other BPAC members, who probably went through the basic questions at the last meeting, didn't. Coffin questioned/spoke the most, other than Dr. Nelson during the Q&A/discussion periods after each presentation.

There was, indeed, a Chair, but he didn't demonstrate much skill at running at meeting. When the confusion ensued regarding what a Yes or No vote meant, he didn't appear to ensure that everyone was clear about what their votes would mean beforehand (as you saw in my notes, I wasn't either). However, after the voting, the Chair reiterated and re-read the question and stated that the recommendation of the Committee was to indefinitely defer. So, I have to think that if any of the members were surprised at the outcome, they would (certainly should) have spoken up at that point, and none of them did. The little patient group of us (the PA, his son, Heidi) were sure scratching our heads!

They didn't add a recommendation to provide educational materials to potential donors or give input on what a question about ME/CFS status might say, although this was discussed. Perhaps the scope of their recommendations is limited by the questions that were put forward in advance and they aren't permitted to broaden the scope? I don't know.

I'm also curious about what led to the additions of Coffin, Klimas (and apparently Nelson) to the Committee. If this was discussed at the last meeting and/or there's a thread somewhere about it, I'd really appreciate a link to it. Thanks.