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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. anciendaze

    anciendaze Senior Member

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    Relative to the 4 people tested here we have another piece of information. WPI researchers sent a panel of 20 samples they found positive to CDC labs prior to the 2009 publication of the Lombardi paper. Samples also went to Singh. Singh is reporting detection rates generally in line with WPI, even if there are differences on specific samples. Does this say anything about cooperation, replication and delay?

    General observations:

    1) Committee members need not take any position on causation by XMRV to vote for a precautionary blood ban. Other evidence shows people with CCC definition ME/CFS have an order of magnitude more infections than the general population. This fits existing criteria for excluding those who are not in good health.

    2) As long as the composition of the front row keeps changing the way it did at this meeting, we are making progress.
  2. Bob

    Bob

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    Good post, free at last... thanks for that...
    You're right, it's going to take a while to unpick all of this information, especially as we've only received dribs and drabs, in broken sentences.
    Like you say, it was disappointing, but there's a lot to work with, and the evidence is always getting stronger, not weaker.
    Did I read that XMRV has now been detected inserted into human DNA? That's really significant news.
    And when we see the exact details of the Phase IIb results, it might be more positive than it seems at the moment.
  3. George

    George waitin' fer rabbits

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    More Drool

    Hey ya, this is my little puddle of drool and it may or may not make a lot of sense due to major a CNS freak out right now. But ya know a dogs gotta drool! (grins)

    Pretty Please
    First of all can we like get together and pitch in and get Val a nice gift card??? What she did was extraordinary. . . And incredibly difficult, I know I couldn't do it. It's a thought and maybe we are all tapped out but I asked my ex last night and he's agreed to let me use his paypal account if we all decided yes. A gift card to a nice restaurant, ya know steak and taters all around, with big ice cream Sundays for dessert or something.

    And He's Ugly Too
    (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.)


    HUH!

    Speaking of bones I 'bout choked on one when I saw the 4 samples used for the BWG Phase II. I'll of course reserve complete judgment till after Friday's Webinar. I had originally heard it would be about a dozen samples, which I thought was kinda small but reasonable. But 4 samples was just plain silly. Which of course lead my little doggy mind down the path of . . . you got it "delay-ville".

    Now that's not to say that this virus is not pushing the cutting edge of the cutting edge. (So much for finding it in Coffins swimming pool! (big grins)) But if you know you are pushing the envelope why would you do so little in the way of producing a set of good assays??? Plus, according to Dr. Mikovitz, Dr. Ruscetti has been working with Dr. Alter and Dr. Lo, showing them how to tweak the assays and find XMRV as well. These guys understand where they are and what they are up against. So again why design a study that is pretty much doomed to give you unreadable results????? Plus, these guys are way, way, way to confident that this is "it" and are already moving into new directions. Like the Ruscetti's working with animal models and the WPI working on setting up a clinical trial board.

    Sometime in the next couple of months some nice quite studies are going to be released. In particular Dr. Illa Singh's study which should point the way to the repository for our little family of viral friends, (cough, bone marrow) and supposedly the next phase of study can begin. But folks it's not like the information from Dr. Singhs study isn't known to these scientist. So is the delay in the Phase II portion of the testing a result of knowledge that the blood is only going to top out around 70 to 80% even under the best of conditions???

    If we really are pushing the limits of detection with current methods, if the reason why we as a patient group have spent decades in limbo is due to the fact that the virus is in a very inconvenient place like bone marrow (grins, yeah that's my pick) or spinal fluid or the brain or lymph nodes then like many really smart people on the forums have already said then it takes medicine into whole new areas and makes us some of the first of the exotic pets in the new zoo. (grins)

    New Zoo Rules
    Likely part of the delay is so that information can be release and a new directions can be "seen" to be taken. Part of the delay is so that a simple set of test that define ME/CFS can be recommended to doctors via the new NIH website. Patients will have next year to get defined as ME/CFS via immune test or some such easy to detect via blood kinda test. Test that don't have anything to do with XMRV but with specific immune dysfunctions that will define ME/CFS.

    Then we get to be the lucky people who will face some interesting possibilities, we get to take drugs and see if we get better no need to involve the XMRV test's at all or we get to get some kinda biopsy for XMRV virus and then get treatment and go from there.

    It's all very interesting. I think a lot of the weirdness we are see is because we are facing a paradigm shift as Ancientdaze points out. A whole new set of illnesses that bypass the sexy gold standard of blood and begin to delve into tissue and fluids that we really haven't developed a lot of testing methods for and maybe that's why the brought in Dr. Lipkin. . .hmm

    O.k. I'll clean up my puddle of drool now. (grins) Hope some of it made sense.
  4. Bob

    Bob

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  5. Otis

    Otis Señor Mumbler

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    Another fluid George, but don't piddle on the floor. :)

    Don't we also have a possible urine test? Brain dead, can't recall who was working ion that. Cleveland Clinic?
  6. Otis

    Otis Señor Mumbler

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    Another fluid George, but don't piddle on the floor. :)

    Don't we also have a possible urine test? Brain dead, can't recall who was working ion that. Cleveland Clinic?
  7. George

    George waitin' fer rabbits

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    Yes Dr. Kline (sp??) at the Cleveland Clinic and there is a company out of Canada that is selling them as well. So yeah, That is a good possibility that they may have to look at that with a antibody test. But really it's going to be heck to play to make sure it's out of the blood supply if they can't put a really reliable blood test together and find a way to check and see if it's really accurate!
  8. Jemal

    Jemal Senior Member

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    How common is it for people with ME/CFS to donate blood?
    http://blogs.wsj.com/health/2010/12...onic-fatigue-syndrome-patients-to-give-blood/
    Still pretty common it seems, unfortunately.

    Anyway, I don't think banning ME/CFS patients to donate blood is really going to help. It's a first step and I am glad for us, as it does give us some more credibility. In the end though, they need to screen every person donating blood for XMRV. Or they need to develop measures to filter XMRV from the blood.

    ME/CFS patients are probably just the tip of the iceberg... why aren't they worrying about the 8% of the population that might be infected, but is not displaying symptoms (or they have symptoms which are not yet associated with this virus). Shouldn't this give some people nightmares!?

    I always thought bloodbanks already had sufficient measures in place to detect and destroy pathogens, but unfortunately these measures are not always sufficient:
    http://forums.aboutmecfs.org/showthread.php?9011-Human-infections-with-animal-disease-rising
  9. George

    George waitin' fer rabbits

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    Hey Jemal
    I think Dr. Klimas shares your exact concerns! (big grins) I think these guys know that it is impossible to contain this and that they are going to have to look at something like the Gen-Probe Tigress system to deal with not only XMRV but any other retroviruses that are mostly tissue based but do slip into the blood from time to time.

    It's a whole new ball game looks like. Looks like they are going to have to come up with a whole new strategy on how to deal with it.
  10. Cort

    Cort Phoenix Rising Founder

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    Why did they expect this mess to be cleared up with four samples. It sounds like they should have done this

    from the beginning. This is good though - 2/3rds of them found XMRV in some of the samples (they don't say healthy or controls). But they do say the samples were 'unblinded' for WPI and CDC and blinded for NCI- they almost sound like they are making this up as they go along. Why give different labs different protocols?

    What was the protocol for Phase IIB? - That was where sample detection dropped. They could only find it in PBMC's. One out of 4 labs found it instead of 2/3. An antibody test from a lab could not detect it. Something was different during Phase IIB.
  11. eric_s

    eric_s Senior Member

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    I also don't get it, why they only tested 4 positive and 1 negative samples... What kept them from using a "normal" number?? It just doesn't make sense to me.

    And then they said it will take years to solve the question of causation. No way... i can't believe it's not possible to get there faster. It will have to be.
  12. Cloud

    Cloud Guest

    I recall early on something about Dr Judy finding live and replicating xmrv in plasma (some frozen) from Dr Petersons repository....some from over 2 decades ago. To the best of my understanding, that would mean the bug is infectious and transmissible in blood. We do need to rule out contamination and replicate earlier studies, and yet this BWG meeting seems more like a circus than scientific debate. Seems highly probable that the blood supply is already contaminated with retro-virus anyhow....the remaining question would be it's level of virulence.

    I don't understand why they don't err on the side of caution until we are certain anyhow. Seems that lesson should have been learned with AIDS. I think a little panic is better than risking further spread of a potentially virulent retro-virus.

    I'm thankful for the strong voices on the panel and those relaying the events to the rest of us.
  13. jspotila

    jspotila Senior Member

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    DHHS has expressed interest in the number of people who register for/attend the Association's webinar on the BWG study as a way of gauging the community's interest in the study. You can register here: https://www1.gotomeeting.com/register/985931313

    Show them we're interested! And (I hope) get answers to questions arising from yesterday's presentations about the BWG study and results.
  14. urbantravels

    urbantravels disjecta membra

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    Thanks, jspotila - I think what we were able to glean via second-hand liveblogging and tweets yesterday raised more questions than it answered! So this webinar is a great service to our curious community. I think I was probably among the very first to sign up.
  15. Otis

    Otis Señor Mumbler

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    This message has continually gotten lost in the mix and it drives me batty. I thought the press would dig into this when Lo et. al hit the press. WRONG.
  16. biophile

    biophile Places I'd rather be.

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    What, me worry?

    The results from BWG Phase IIa were a disappointment, but the quoted speech from Alter was awesome. Also, 4 samples seems remarkably low, why not at least 10? And why not do multiple blood draws on the same person?

    I agree, it does seem a little odd, but I'm betting there are numerous factors involved. The issue simply isn't perceived as important as other big news stories to cover, like Paris Hilton's brush with the law. Swine flu has caused "outbreak fatigue", don't want to scare the public again or risk media-induced hysteria without lots of evidence. It's cutting edge rocket science, there is no gold standard of testing yet, and causation isn't proven for any disease. The supposed authority on infectious diseases (CDC) has been denying CFS outbreaks for 25 years. People successfully fight off or suppress common viruses all the time and it hasn't sunken in yet that RETROviruses are in a whole new league. Lots of viruses have (allegedly) been a dead end in CFS research, and CFS is perceived as a non-disease of hypochondriacs, we might as well be saying that "a new virus which doesn't cause symptoms in healthy people, and has not demonstrated to cause any disease in anyone, may be associated with complainers and delusional worriers who aren't really sick".

    Perhaps Alfred E Neuman from MAD magazine can become the CDC's new mascot, "What, me worry about CFS and human gamma retroviruses?" ;)

    [​IMG]
  17. Cort

    Cort Phoenix Rising Founder

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    They were able to dig virus out of a sample from 1984. Coffin suggested that the virus probably got into humans recently because it hasn't diverged all that much, I believe, but in scientific terms its really hard to know what recently means? 40 years? 100? 500? The feds will certainly dig into their blood stocks to see when it started showing if they confirm XMRV....that would be really interesting given the earlier accounts of ME outbreaks.

    Here's my take on the meeting. I considered it, for want of a better term, a draw - both sides got their points in and neither convinced the other :)

    http://forums.aboutmecfs.org/content.php?295-A-Draw-at-the-Blood-Working-Group-Meeting
  18. Marco

    Marco Old blackguard

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    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:
  19. free at last

    free at last Senior Member

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    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 thats 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 ?
  20. free at last

    free at last Senior Member

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    I remember this article Gracenote, and yes again it struck a chord. recovery really is a word that doesnt really apply ( though i am guilty of using it myself ) but i mostly say partially recovered. long periods of time can elapse between the fluey feelings arising. conversly they also seem to be able to strike at intermittent times during those long periods of fairly stable health.The mornings for example can often be filled with them, only to dissipate as the morning or day progressis, and ( this is the important crunch point) of a similar feeling comparatively to times when i was much more physically ill. even similar ( but in a 100 fold reduced severity ) to the numerouse onset times that led to the condition becoming chronic, with 102 temperatures.

    Also ive noticed ( some will call this old age ) I dissagree. That the fatigue element seems if any thing more progressed than the past, meaning of course when i had the severe flu like onset attacks, the aching fatigue was worse yes ( was like swine flu worse ) but during times of recovery from that, the fatigue itself was under control and not always a particulaly bad aspect of it. ( compared to the ill fluey poisend effects that i had so often ) yet as these type of symptoms over the years became more under control, the fatigue element does seem to be progressing, both in muscle and joint problems, even at times of fairly symptomless periods.

    Indicating to me that this disease is on going, and still progressing. But in a new way, with the immune system problems modifying themselves for what feels like for the better, but infact only from the poisend aspect. ( Which isnt intirely gone of itself ) But most defiantly not from a muscle or joint problem perspective that is a commom symptom of ME/CFS that is and most likely will remain on going and progressive, brain fog, concentraion and memory, word retreival problems are also intermitantly on going. This study is correct Gracenote.
    One last thing i want to touch on, it has been mentioned where does XMRV like to hang out, well i dont think ive read anyone mention muscle tissue.I could be wrong and there may be reasons that i dont fully understand that might exclude permanent muscle infection of xmrv, But here goes, since the illness started i have never ever fully got rid of a general aching in my left leg calf muscle, for years ive realised it is connected to ME/CFS but never really understood what that was all about. So is it possible, that higher concentrations of xmrv could be found there, during say a biopsy ? ive noticed other ME patients have this muscle leg involvment. one recently filmed by the bbc, about the pediatric ME white blood cell anamoly found in Pediatric ME patients. Is this a place XMRV could be found ? or are we seeing cytokin toxic damage caused by a constant immune response to xmrv possibly ?
    I note spinal fluid was mentioned as a possible place to look for xmrv. And then i remembered about Sophia Mirza. When the Autopsy was done, they noted that alterations or signs of disease was showing in her spinal fluid, that led to the cause of death, on her death certificate as being lableded ME for the first time. Clearly we should be testing the spinal fluid for high conentrations of you guessed it. xmrv

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