1. Patients launch $1.27 million crowdfunding campaign for ME/CFS gut microbiome study.
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Hunting down the cause of ME/CFS & other challenging disorders - Lipkin in London
In a talk to patients in London on 3rd September, Dr. W. Ian Lipkin described the extraordinary lengths he and his team are prepared to go to in order to track down the source of an illness, with examples ranging from autism to the strange case of Kawasaki disease.
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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. urbantravels

    urbantravels disjecta membra

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    Science in an emerging field is always this messy, if not way more messy. What's new is having such an extensive online peanut gallery watching in real time, or trying to.

    If enough resources are being devoted to the problem, and enough different groups are working on the problem with a good-faith effort to find the truth, the messiness should not be too much of a concern.

    I know what really concerns us as a patient community is that the pattern of the past might be repeated - when the going got rough, and the pathogen didn't easily present itself, the effort was completely abandoned and a huge tide of negative bias, patient-blaming, and common knowledge that "studying that disease is career suicide" acted to choke off the science for decades.

    When we hear anyone say that "this study will settle the question for once and for all," naturally we get nervous. Because no one study can EVER do that, and "settle the question" sounds a lot like it could be the sound of the prison door slamming on us once again. We have our biases based on past experience; but it's antithetical to the very idea of science that anybody should be standing up on their hind legs saying they are about to "settle the question for one and for all." That's politics, not science; and for very good reason a statement like that is the opposite of reassuring to the patient community.
     
  2. CBS

    CBS Senior Member

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    Well put. This is messy and hard and being done under the scrutiny of a patient population like never before (Mangan - and everyone else who's now involved - probably curses Reeves name every morning as they get out of bed).

    As for "standing up on their hind legs," you can do that? I'm sure that George can relate but I feel like I've just been sniffin' butts for the last 16+ years.
     
  3. eric_s

    eric_s Senior Member

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    Sorry but i'm not able to answer your questions, maybe someone else can. My take is that at this moment it's not really possible for us to really know something "for sure" in regards to XMRV. So i think what helps us most is to try to figure out what we can do to speed up and support the scientific process that will hopefully lead to more knowledge. Trying to solve one's own case and get to an answer seems almost impossible to me at this moment. I think we can achieve most if we get organized as well as possible, because this will give us far more leverage than as individuals. So i think i will join a CFS org and try to get things done from there. We need tons of money, coordination between the CFS orgs and coordination and cooperation between the scientists involved. The higher the percentage of PWCs that are active in this, donating and being members of an organisation, the more success we will have, i think, and faster.
     
  4. shannah

    shannah Senior Member

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    Is anybody watching the CAA presentation yet?

    Mine doesn't seem to have started and it's 1:07 here EST.
     
  5. jspotila

    jspotila Senior Member

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    Going on now. Just started.
     
  6. floydguy

    floydguy Senior Member

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    I think the problem people have is that the process seems so inept. Also, most people are okay and welcome healthy skepticism but that is not what Family Guy appears to be doing. As PA says, he seems to be on some kind of hatchet mission.
     
  7. urbantravels

    urbantravels disjecta membra

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    Don't make me post another picture of Little Dummy to prove it! Actually, in all honesty, he can't stand up on his hind legs - he quite literally has a stick up his butt.
     
  8. acer2000

    acer2000 Senior Member

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    I agree, they should test Chia's GI samples as well since he took so many of them and they also showed positive in the monkey study.
     
  9. free at last

    free at last Senior Member

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    yes i understand thats whats needed.wish my knowledge was more complete, to help more understanding too. No worrys Eric. you all do great things helping to understand all this. Cheers
     
  10. Jemal

    Jemal Senior Member

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  11. alex3619

    alex3619 Senior Member

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    Hi, the webinar did leave me with one important point: the aim (or retrospective revision of aim?) was to determine the best way to treat blood: should it be tested as whole blood, peripheral blood mononuclear cells, or plasma. They wanted to know if they could use the huge stored blood repositories, including those with recipient-donor data and follow-up data and blood samples. With this they will be able to track infection and what happens to patients after infection. However, those studies are still not ready to go, they may even have to wait until after phase 3. So far as this research is concerned, only PCR and serological assays are viable because they are very quick. They want to be able to test 10,000 blood samples per day. So phase 2 was a pilot study to give an indication of how to proceed (my words, not theirs).

    There were two long delays in this process. The first was pedigreed blood sample determination: these samples were tested by all labs, including up to 42 days of culture, to decide if each was positive or negative. The second huge delay was several months before an ethics committee. We really need to do something, as patients, to streamline the ethics side: non-invasive studies, or with simple blood tests, need to be fast-tracked. We need results asap.

    The second major point is phase 3 will start in January. It is expected to take six months. It is much larger (many more samples) and blinded.

    Bye
    Alex

    Future
     
  12. anciendaze

    anciendaze Senior Member

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    Can anyone explain the central ethical questions which required months to resolve? Was anyone worried that running such a study would encourage "false illness beliefs"? (Yes, I know I'm imagining things, but is this very far-fetched?)
     
  13. Cort

    Cort Phoenix Rising Founder

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    Thanks Alex for figuring out what happened. That takes some of the angst away - and suggests that things will move more quickly (altho I suppose they still have to go back to their board?).. Ethics delays appear to be common in govt research - much easier to negotiate in private labs - from my very limited experience. Everybody seems to groan about the IRB boards..
     
  14. Cort

    Cort Phoenix Rising Founder

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    It usually has to do with patient privacy and how much the patient should know. In a sense you have a point because they have to decide whether or not to tell the participants if they test positive or not. With a new possibly infectious retrovirus - I'm sure it was a bit more complicated than usual. God knows why it takes so long though...
     
  15. Cort

    Cort Phoenix Rising Founder

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    I retract that statement about beware of the WPI tests.......it was done in the heat of the moment...later I realized that the WPI repeatedly tests their samples and then sequences the positives to make sure they got the right stuff - It seems like a good test to me......

    We didn't get the whole story in that little test the BWG did.
     
  16. Cort

    Cort Phoenix Rising Founder

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    Only the culture test - which seems to be quite consistent....On the other hand there's nothing to validate it against; you really need two good tests to validate any one test...and we're definitely not there yet.

    We really will know once they get more negatives in there - if the WPI identifies all the negatives correctly then its fine for them to just keep testing samples to see if they turn up positive... They can miss on the positives just so long they don't miss on the negatives...I'm sure they have their own internal tests and they've looked at this alot.

    This test was so small - 1 blinded sample...its really hard to tell anything...Plus, as noted earlier - the WPI only does culture now -does it not??? So these tests don't reflect the patient tests done at the WPI or VIP Dx, I don't think....
     
  17. jspotila

    jspotila Senior Member

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    The ethics committee process is the IRB, or institutional review board. Every research study involving human subjects in the US must be approved by the IRBs for the institutions involved. The IRB reviews the entire study design, consent forms and process used with subjects, etc, and a study can't go forward without the IRB approval. It takes time for the IRB review, and longer if changes have to be made to the study in order to secure approval. Tests on existing samples (as long as collection of those samples was IRB approved) can usually happen pretty fast. The SolveCFS BioBank is IRB approved, so sample donors do not have to be re-consented for each individual study. But the BWG Phase II involved NEW samples, and so that study design had to be reviewed and approved by the IRBs for WPI and the other institutions.
     
  18. acer2000

    acer2000 Senior Member

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    Nothing can be inferred from the BWG about the reliability of the culture test between labs because the BWG purposely didn't deal with it. They stated up front that culture type tests aren't useful for screening large amounts of blood samples cheaply, so they focused on PCR and serology to see if they could agree upon a standard test between those labs. The conclusion at this point appears to be that they can't.

    We will have to look to other groups/studies to replicate the WPI study using the Culture first/pcr second method. Its pretty annoying that nobody up to this point has been able to or even tried to do this.
     
  19. pictureofhealth

    pictureofhealth XMRV - L'Agent du Jour

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    I guess the bottom line worry I have is that if XMRV cannot reliably be found in the blood using PCR and serology, then that will be the 'headline' conclusion and many might then conclude that 'its not there'. Federal interest in ME/CFS research might then fade away.

    I do hope that following his comments, Dr Alter (and hopefully Dr Lo) will stay the course whatever happens and continue looking for answers, look at tissue samples and use culture and explore other research avenues in ME/CFS - not just blood tests.
     
  20. alex3619

    alex3619 Senior Member

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    HI pictureofhealthy, I don't think this can happen now. The worst case scenario is that we lose a lot of research money that might have been available if rapid blood testing becomes easy, and many good studies on XMRV transmission via blood transfusion will not happen. There seemed to be a consensus at the Dec 14 workshop that culturing for XMRV is effective. What I suspect will happen is that funding will decrease, the need for culturing will make studies smaller (due to higher workload and costs), and everything will take very much longer. Fast easy blood tests mean automated testing of seriously large numbers of blood samples at relatively low cost - losing this will put the brakes on, but not all the way. Bye, Alex
     

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