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BWG Phase Two Results - Webinar

Discussion in 'Media, Interviews, Blogs, Talks, Events about XMRV' started by jspotila, Dec 11, 2010.

  1. jspotila

    jspotila Senior Member

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    The recording of the webinar has been posted: http://www.youtube.com/watch?v=By3V9oXCFxg

    Unfortunately there were technical problems, so the recording starts halfway through Dr. Simmons' presentation on Phase IIb. However, Dr. Simmons has already agreed to record the presentation again as soon as it can be scheduled.
     
  2. shannah

    shannah Senior Member

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    Here's what Amy at WSJ writes:


    December 17, 2010, 4:43 PM ET XMRV: Still Waiting For a Test

    Earlier this week, an FDA advisory panel recommended that the agency bar people who report a diagnosis of chronic fatigue syndrome from donating blood amid concerns about a possible link with the virus XMRV.

    But reliably testing potential blood donors or people with CFS for XMRV isn’t yet possible.

    That’s the conclusion from the latest phase of an ongoing study launched by the HHS Blood XMRV Scientific Working Group, which was set up last year after a paper in Science linked XMRV to CFS. An update on the study was presented to the FDA advisory panel and again today on a webinar sponsored by the CFIDS Association of America, a patient advocacy group.

    Many groups are racing to develop an XMRV test in case it turns out that potential blood donors need to be screened for XMRV. But in a presentation on today’s webinar by Graham Simmons of Blood Systems Research Institute, the lab that has been coordinating the working group studies, one of the slides summed it up: Participating Labs — Discordant Results.

    The first phase of the study evaluated the performance of XMRV tests developed by a number of labs, including the Whittemore-Peterson Institute (which first found the XMRV link to CFS), the CDC, FDA, and National Cancer Institute, among others. All the tests did very well when looking for XMRV in blood samples that had been spiked with it.

    But in the second phase of the study, which had a subset of the labs look at clinical blood samples from four people who tested positive for XMRV in the Science study, things didn’t go as smoothly. In round one of this second phase, the CDC and the WPI labs were able to find XMRV in the plasma of at least some of the patients. The NCI lab did not find any positives, despite having a very sensitive test. So, they decided to do it all over again in the hopes of confirming the findings. “Instead it went in the opposite direction,” Michael Busch, director of Blood Systems Research Institute, tells the Health Blog.

    When the same four people gave blood again, the three participating labs — plus a fourth commercial one — didn’t find XMRV in any of the plasma samples.

    Some of the possible reasons why were discussed on the webinar. The number of people involved was tiny, and it turns out that one of the four actually does not have a CFS diagnosis but was a family member of someone with CFS. Another one of the four started taking anti-retroviral medication around the time her blood was drawn, which also could have impacted the results. Or, it’s possible that the amount of virus present varies over time and was low when these samples were taken.

    So what’s next? Phase 3, which is going to include much larger numbers of CFS patients (30) and even larger numbers of healthy controls (40-50), say the working group scientists. More commercial labs are likely to be brought in to do testing. Blood will likely be drawn in January, with results in possibly three months later. “It is a frustrating process,” Busch says, “but we are staying the course and moving to Phase 3.”
     
  3. Otis

    Otis Señor Mumbler

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    Looks like a good chunk is cut off. I hope they are able to post the entire thing.
     
  4. jspotila

    jspotila Senior Member

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  5. Recovery Soon

    Recovery Soon Senior Member

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    Are they for real? We're waiting around here for months on end while Inspector Clouseau is bumbling around the bloodblank?

    I don't have the patience to parse through all of this noise. Maybe by 2025 we'll have a test to know if this retrovirus, which may not be pathogenic, is associated with our poorly defined condition.
     
  6. CBS

    CBS Senior Member

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    I agree wholeheartedly.

    On the other hand, Alter is in an interesting position as his background is blood safety and he is apparently hard at work on that aspect but he was also a very strong voice for CFS patients when he spoke out on Tuesday. He does not see the urgency for CFS patients and the risk to the blood supply as being tow separate issues (but at least for the near future, we are probably talking about two tests - a clinical measure and a screening tool).
     
  7. Sam Carter

    Sam Carter Guest

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    (emphasis added)

    A contradiction, surely, unless the person was from the control group.
     
  8. Otis

    Otis Señor Mumbler

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    Many thanks to Dr. Simmons!
     
  9. urbantravels

    urbantravels disjecta membra

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    I'd have to more carefully review the actual presentation, but I'm not totally sure Amy's interpreting the presentation correctly in her article.
     
  10. Esther12

    Esther12 Senior Member

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    Yes. Thanks to all those involved with putting this together.

    It's all a bit confused and disappointing, but it's really helpful to have some more information about why that is. Thank you!
     
  11. SOC

    SOC Senior Member

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    The 4th patient was an XMRV+ family member who is not showing signs of ME/CFS. A fine positive control for finding XMRV. They do, after all, want to be able to screen out XMRV+ people who haven't been diagnosed and therefore don't self-defer.
     
  12. Sam Carter

    Sam Carter Guest

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    So this must have been one of the controls in the Lombardi study? The webinar slides confirm that the four +ves came from the Science cohort.

    p24
    """"""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""
    WPI collected blood from four subjects (mostly with CFS)
    previously identified as XMRV positive in the Lombardi et al.
    study (by PCR, serology and/or culture)
    """"""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""

    ETA: this means that the healthy controls -- from memory they were people who had provided blood to a local immunology clinic -- must have been notified of the results of the WPI testing.
     
  13. SOC

    SOC Senior Member

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    Okay, I have a bit of a mental gymnastics to do listening to these things as both a (former) research scientist and a patient. Hard to be both at once.

    From the researcher prespective, I'm having a hard time understanding the sample selection. I know their time was limited, but 4/1 is such a small sample that, particularly when copy number is so low, results are statistically insignificant. Add to that a sample that becomes questionable because of ARV therapy. Granted they didn't know, but a certain amount of prescreening of potential sample donors to avoid such snafus isn't that hard. Finally, if you're not sure you can detect the virus at all, it seems wise to start with samples from the sickest patients. I don't know all the details, of course, so they could easily have good reasons for doing what they did....

    On the positive side, I was reminded of my researcher friends saying over the summer "If it's published in Science and PNAS, researchers are going to be taking it as a given". The researchers we heard today were not questioning whether ME/CFS patients were XMRV/MLV positive; they were past that and focussing on how to detect it. I think that's great news for us. McClure and Reeves can do their dirty, but the research world as a whole is leaving them behind. Politics, on the other hand, is still piddling around looking for its own behind.

    Overall, I felt good after this webinar. I think the news was generally positive for ME/CFS patients. They're taking us seriously, finally. They're trying to detect XMRV. These are good things.
     
  14. SOC

    SOC Senior Member

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    Many thanks to Dr Simmons for being willing to redo the presentation. I'm sure he's a busy man and it's kind of him to take the time to repeat his work so that more people can hear his report.
     
  15. SOC

    SOC Senior Member

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    I don't remember now, about the controls in the Lombardi et al study. Did they separate contact controls from non-contact controls?
     
  16. Sam Carter

    Sam Carter Guest

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    I think all the controls were assumed to be non-contact. They were provided by Ken Hunter from the University of Nevada who was running a study to examine cytokine profiles and immune phenotypes.
     
  17. SOC

    SOC Senior Member

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    Hmmmm...... so maybe the contact controls came from other studies? WPI reported cases of autism (and other illnesses) in XMRV+ family members, didn't they? So they studied non-patient family members at some point....
    [wishing my memory was better....]
     
  18. jspotila

    jspotila Senior Member

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    Slide number 25 from the presentation described the four pedigreed positive subjects. Subject #1 does not have CFS, but is a family member.

    From slide number 24:
    ETA: Oops, someone beat me to it. That's what I get for not reading the whole thread before replying!
     
  19. biophile

    biophile Places I'd rather be.

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    This makes me feel a little better about the whole situation.
     
  20. Cort

    Cort Phoenix Rising Founder

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    That's the disappointing thing. They are developing the best test to using in screening blood - which makes sense in some ways. We thought they were interested in the best test period - but it turns out that is not their mission and never has been.

    Now if you could find XMRV without culture everything would be fine and they would be our 'go to' guys but not even the WPI can find XMRV consistently without using culture. It turns out that the one test XMRV shows up well in is the one test they are not interested in....

    It just shows how much the finding of XMRV in the blood supply has dominated their attention. Their main goal was never to figure out what's happening in CFS - its always been directed to the blood supply.

    I don't think most of them thought, however, that culture was going to play such a major role; that is another of XMRV's surprises....With the technology available now I'll bet they thought they would have a straight shot at it. Indeed nothing in the Science paper suggested that they wouldn't - the WPI used a normal PCR test to look for XMRV and they found it...

    What wasn't in the Science paper was that at times they had to search multiple times for it - but they also said that at times it just showed up....which means to me that the mystery continues --if rarity was the only problem it should have showed up at least somewhat in the studies.....but that's not what is happening - we still get this zero/zero or abundant/low pattern; you either find it abundantly in CFS and in low amounts in the controls or nothing.....which does not make sense if it was so rare that they simply had trouble finding it.

    They should be able to find it some of the time using ordinary PCR.....because that's what the WPI did - the WPI did straight nested PCR to find the gag sequence; that was their major finding - and they were using the standard prostate clone to do it I believe; it's just necessary to use culture to find it everywhere it is...There is something different with the nested PCR's that everyone is using...

    I honestly can't believe we are still where we are....NOBODY expected this; the WPI, NCI and Cleveland Clinic thought XMRV would just sail through - a few confirmatory studies would validate their findings and then we'd be off doing treatment studies in six months......its amazing!!!!
     

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