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

Discussion in 'Media, Interviews, Blogs, Talks, Events about XMRV' started by Otis, Nov 26, 2010.

  1. Cort

    Cort Phoenix Rising Founder

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    I'm sure the Coffin samples were not the WPI - I imagine we would have heard that. For sure, it was a contaminant from somewhere...

    More samples next time should straighten this out.
  2. Cort

    Cort Phoenix Rising Founder

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    Darn Eric - you're right. They mis-identified the positive sample half the time. Actually all you can say is that they can't identify the negative sample consistently..Its good they have a reason for that but that'll have to wait for another day....

    Putting the data in a chart suggested that the WPI was able to correctly identify the positive only 2/5 times..They got the negative right 1/2 times....

    They didn't even mention in this chart what happened to samples 2,3,4 on Day 0!

    Honestly what a lousy phase this was; it was blinded but there were only five samples and as leaves pointed out - the CDC did a different test the second time...If your job was to determine if contamination was present at the WPI's lab - how can change tests in midstream????

    I think Jennie should ask them - do you have enough money? Are you really focused on this? By the way, if you're only going to do four positive and 1 negative sample - why did this take so long????? How long have they been at this?
  3. Otis

    Otis SeƱor Mumbler

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    "You can bet your bottom dollar if I tested negative in a WPI study that I would be calling to see if I were that false positive."
  4. Esther12

    Esther12 Senior Member

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    To me, it really looks like there isn't a test for XMRV which is ready to be marketed to patients.
  5. biophile

    biophile Places I'd rather be.

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    I agree with Cort. BWG Phase IIa and IIb were messy and inadequate. Sure, HGRV presently appears to be very difficult to detect reliably in clinical samples (so that cuts them some limited slack), but it doesn't look like much resource is going into the BWG's efforts, a few casual samples over several months? I guess it's easy for us armchair critics to post comments expressing frustration, but WTF's going on over there? Whatever timetable we get tomorrow is probably going to be conveniently pulled out of someone's ass on the fly to placate us plebs.

    Also, if Lipkin is such the innovative rockstar virologist with groupies lining up to be hanging off him, why isn't he being funded to get more involved in developing the assays? Why isn't the legendary "virus hunter" actually hunting any viruses in this situation, merely playing a supervisory role in a future study once all the groundbreaking work is done by others involved in the same "controversy" that Lipkin is supposedly going to resolve?
  6. jspotila

    jspotila Senior Member

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    Wait, how did I get nominated for this?! :eek: But in all seriousness, I think these and other questions in this thread are good questions, and I hope they will be answered tomorrow.
  7. Lynn

    Lynn Senior Member

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    Hi Pictureofhealth,

    That is interesting to me about the immune system. When I tried LDN over a nine month period, I feel like I woke up a sleeping giant (or virus). My overall functioning really plummeted when taking LDN and has not returned. A few months after the LDN episode I had the serology test done and was positive for XMRV. I am not sure that would have happened before LDN.

    Of course, I am not suggesting that anyone try LDN or anything else just to stimulate their immune system to get more accurate results in the testing. It has been six months since trying LDN and I still have not returned to my previous LDN state.

    Lynn

    ETA -
    Based on the WPI's results, now I am not so positive about being positive.
  8. Valb626

    Valb626

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    I'm sorry I couldn't be clearer in my posts. I wish FDA would post the actual slides, which are presented as handy tables and much easier to understand than my notes. A couple of things:

    In Phase 2b, there were no Day 4 samples tested by any lab. They didn't include a Day 4 in Phase 2b - only in Phase 1b. So none of the labs reported results for Day 4 in Phase 2b.

    WPI's positive results on the "pedigreed negative control" were both from Day 0. One positive was from using their own PBMC PCR test and the other one resulted from using the NAT they were asked to run, also on PBMC. And the slide explained the problem with their Day 0 PBMC processing, which would have affected both their PCR PBMC and NAT PBMC positive results for the "pedigreed negative control" sample.

    Note, however, that NCI/Ruscetti also got a positive result from this "pedigreed negative control" sample on their serology test, using the Lo/Alter method, but their positive was on the Day 2 sample, rather than Day 0. Although we didn't see specifics at the meeting, I would guess that WPI used their own serology test (maybe), rather than the Lo/Alter method, but we don't know yet (not reported) whether WPI's serology results once again found this "negative control" sample to be positive or on which day(s). But it's still good news, sort of, that WPI isn't the only lab that got positive results on the "pedigreed negative."

    So, it will be interesting if WPI gets a positive result from the "pedigreed negative control" by serology, too. And, if they get a positive again, at least that result would be concordant with the NCI/Ruscetti positive result on the "pedigreed negative control" that was sent to NCI/Ruscetti directly from BSRI without WPI ever touching it. This scenario could leave us with 2 independent labs, using different methods, who both found this "pedigreed negative control" sample to be positive on at least some tests. aargh. There would definitely be some 'splainin to do.

    FWIW, I'm not very happy with the small number of subjects/control in this study design either, but I don't do this kind of science, so I don't understand the reasoning behind why they did it this way. I've been learning a little about lab science, tho, and I'm hearing that many of these methods are still really time-consuming to perform and that running so many different types of tests on so many different "pieces" of the samples (e.g., WB, PBMC, plasma) has to require a lot of resources. So, maybe they only used 4 subjects and 1 negative control because they actually are in a hurry to get answers and this was the most efficient design to get them something they expected to be meaningful as soon as possible? But here we are in Dec., and all the labs STILL haven't finished all of the tests to be done. So, it's clearly much more complicated than they expected it to be going into this.

    If I put on my "scientist hat," this is all really interesting. But when I put on my "Mom hat" with respect to my one really sick daughter and 4 other kids at risk and a brand-new grandson, this is driving me crazy!

    We had decided to wait until after the meeting to have the blood draw to get my daughter tested by VIP Dx. I was hoping everything would be cleared up about testing by now, like we all did.

    But I didn't learn anything at the meeting that has dissuaded me from going ahead with getting the test done. I already knew the VIP Dx testing wasn't FDA-approved (lol), I already knew the methods are still being researched and that I'd be paying out-of-pocket for results that we'd have to take with a grain of salt either way they come back. And, it certainly wouldn't be the first time I've spent a chunk of $$ on tests (and treatments and travel...) that had a lot less science behind them than this does. Obviously, that's only my personal view on this.
  9. Cloud

    Cloud Guest

    I've heard this story many times over the years. It took me only 2 days both times to realize I'm one of those with this kind of reaction to LDN...and if I tried to push through it (like many recommend), I may not return. Nothing makes me more ill than LDN. Point is, these reactions to LDN are very diagnostic (of something). I can't take any immune stimulants either. Stimulating my immune system does something very bad.....I could totally buy this idea that stimulating the immune system brings xmrv out of hiding.....of course that would be assuming that increased levels of xmrv in the blood could even cause such an immune reaction.
  10. alex3619

    alex3619 Senior Member

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    Mantle Histiocyte Retrovirus (MHRV)


    H, Here is a link to a retrovirus isolated in mantle cell lymphoma. It has me wondering:

    http://osdir.com/patents/Chemistry-...istiocytes-mantle-cell-lymphoma-06924095.html

    It appears to be a type of HERV that has become infectious.

    I found this while searching haemophilia mantle cell lymphoma links.

    Bye, Alex
  11. Francelle

    Francelle Senior Member

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    I am obviously totally not getting any of this because I would have thought it was beware to anyone who tested positive at the WPI or VIPDx because of them identifying the negative as a positive. It makes no sense to me if there are only four or five samples and if they knew that four were positive, just name them all as positive and how wrong can you be - 1/5? I'm sure it isn't that simple though - lol!
  12. Jemal

    Jemal Senior Member

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    LOL
    Congrats on making the most depressing post I have read in a while, Cort :D

    Like the other armchair critics, I don't understand why this is all taking so long and why the process looks so messy. Also it does look like they are throwing only a few resources at this virus. What is Lipkin doing? I mean: what the heck!?

    Well, the good news is still that we are getting more attention and that they voted to ban us from donating blood. Although it seems not everyone knew what he was voting for :eek: It's like a very bad movie.

    I wonder, is science always this messy?
  13. eric_s

    eric_s Senior Member

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    Now, come on :eek::angel:
    I don't want to be responsible for Cort making a post that would have a negative influence on people. I was just trying to be objective. I did not do a lot of analysis, because i don't know very much about statistics and i was pretty sure we would get tables etc. by the CAA, as we got after phase 1.

    But i tried to be objective and unfortunately i could not see those results as something very positive.
    It's true that the WPI came up with an explanation for the alleged false positive. But the same thing happened after their false positive in phase 1. Better to be able to present an explanation than no explanation at all, but i would like to see a constantly good result, not a wrong result with an explanation afterwards.
    Not trying to bash the WPI at all, i have donated to them (not much, but i'm not able to do more at the moment), i still believe they are right and i really do admire their work and what they do for us. But i think we have to be objective and try to do the very best possible, if we ever want to get out of this mess, and i think that means we have to ask tough questions to "our side" too. Only in this way can you ensure quality.
    Btw, i think the PCR method applied by the WPI in phase II is not the same that you get when getting tested through VIP Dx (not sure about that though, but it should be fairly easy to verify). Nevertheless i wish the WPI would have gotten a better result with that method, too.

    I am also of the opinion that this setup was really bad (no scientist though). 4 positives, 1 control. To me this seems ridiculous, when your task is to determine wheter there is a potentially deadly retrovirus in your population, that might have already infected 20 millions, making more than 1 million sick, etc. And also i wonder why there are only 4 labs left, all of a sudden (George pointed that one out).

    But on a positive note, i still believe in the positive studies. They were blinded (at least in some cases) and they involved many positive controls. And every time there was a very significant difference between positive results in cases vs controls. And we have someone of Alter's caliber that seems very convinced. I trust him.

    So please don't be discouraged by what i'm writing. I think we have every reason to expect good news. We are so many, we can make things happen. It's impossible, with the ressources we have together, that this disease can't be solved.

    Edit: Just to mention it once again, what i said above was my opinion about the WPI's performance in the BWG so far. I did not say anything about the quality of VIP Dx's testing. Those seem to be other tests!
  14. Jemal

    Jemal Senior Member

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    It didn't have a negative influence on me. I was already a bit discontent with the progress and the process so far. Cort just summed it all up nicely: some things seem to be so ridiculous, I was laughing out loud when I read his post, and my wife asked me why I was laughing :D
    (like I said: it's like I am reading a bad movie script).

    We shouldn't hide the truth from each other. The WPI is loved by many, but if they make mistakes, we shouldn't be afraid to post about it. We want the truth and we want a treatment. I think the WPI is still our best bet and I am glad scientists like Lo, Alter and Klimas are on our side.
  15. eric_s

    eric_s Senior Member

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    Yeah, bad movie script sums it up quite well :rolleyes: Up and down and it's never really possible to make sense of the entire situation so far... incredible
  16. Marco

    Marco Old blackguard

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    I'm just out of bed and still a bit groggy so forgive me if this doesn't fully make sense. But sometimes things occur to you when half asleep.

    We have been wondering why some labs were blinded and some were not. This still makes little sense to me.

    But we have been behaving as is this phase was intended to validate or invalidate WPI's Science paper results. As far as i'm aware that wasn't the intention. The intention was to develop the most accurate and reliable tests for XMRV/PMRVs. Lipkin's study is intended to 'settle the matter once and for all'.

    From this respect, leaving aside any biasing effect on the researchers, it makes more sense to try to refine your testing procedures unblinded. If you know there is a positive sample there you can work towards identifying what is preventing you finding it and similarly with working to eliminate the false positives (sounds like a song?).

    Otherwise it like looking for a needle in a haystack without knowing whether or not a needle is actually there.

    There seems little to be gained in running a beauty contest between the three labs at this stage apart from as a means of initially identifying the most promising protocols to further develop (again leaving aside any biasing effects of not blinding the samples).
  17. eric_s

    eric_s Senior Member

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    But do we now have a reliable and accurate test? To me it does not look like any of the ones used here fits that description... So still some way to go...

    From Val's transript we could read that the WPI said that they were asked to do a type of PCR that they usually don't do. And then from the slides there seems to be another (maybe additional) explanation for the false positive. Why would they not be allowed to test the way they deem the best? If the goal is to get a good assay.
  18. free at last

    free at last Senior Member

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    Hi Everyone, it is unsettling for sure, but hope Judys explanation does in the long term hold true, as far as getting accurrate positives is concerned one does hope the tests they feel are more accurate, actually are. If someone tested positive just 1 out of the 4 tests the wpi currently are using, that would seems the most worrying for obviouse reasons. Can i ask anyones thoughts on the likelyhood of testing positive 3 out of the 4 tests, and them all being false positives ? seems more unlikely i know, but how much more unlikely, does anyone have a idea or opinon on this.
    The idea of Stimulating the immune system to detect xmrv, i think i mentioned sometime back, but it does occur to me that surely that could be risky, great for detection in the blood yes, but do we really want to activate xmrv in ME patients, seems like playing with fire on that one ? one thing i really would love to know, could xmrv be hiding in common muscle tissue, like say calf leg muscle tissue. Its good to see you guys pouring over all this, well done for trying so hard to get to grips with the information available. And Eric your right to voice concerns, we do need thinkers not sheep. even if its painful, as long as its justified and not unjust bias, And thats defiantly not Eric
  19. pictureofhealth

    pictureofhealth XMRV - L'Agent du Jour

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    Hi Lynn, Cloud - quick link to LDN benefits in MS, but off topic for this thread. May repost in another thread if of interest ..

    http://forum.ldnresearchtrust.org/index.php?/topic/6-ldn-fact-sheet/
  20. anciendaze

    anciendaze Senior Member

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    Original science is almost always this messy. Most research is not original.

    As for statistics, anyone who does statistical analysis of single events should be studiously ignored. With one certified negative control, this panel was in that category from the word go.

    Conclusion: this test was never designed to settle any dispute.

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