Wednesday, September 21, 2011

TO BE OR NOT TO BE

Tomorrow Science will publish the Phase III study by the Blood Working Group, which includes scientists at the Whittemore Peterson Institute, the Food and Drug Administration, the National Cancer Institute, the Centers for Disease Control, and the commercial labs Abbott and Gen-Probe.  

Tomorrow at 3 p.m. EST, ScienceLive, a weekly live chat hosted by Science's Martin Enserink, will delve into "the science and controversy surrounding Chronic Fatigue Syndrome," explained the show's producer Daniel Strain in an email.  Those interested in participating in the show can click here and post questions to guests Dr. Michael Busch of the Blood Research Institute in San Francisco and Dr. Jay Levy of University of California at San Francisco. Levy's XMRV study didn't find the retrovirus.

The Blood Working Group Phase III study examined whole blood, PBMC’s (peripheral blood mononuclear cells, which are cells with a nucleus, key players in the immune response), and serology (antibody testing). They looked at the blood of ME/CFS patients who were positive in the Lombardi and Lo papers, as well as pedigreed negative control donor samples and spiked positives.  Several samples from about 70 different subjects were tested using at least 15 different assays.

Dr. Michael Busch's Institute oversaw the study and broke the labs' codes.  In an August interview with CFS Central, Busch said, "Our Phase IV and other planned studies of donor and recipient infection are contingent on results from Phase III documenting reproducible and specific detection of virus/antibody." In other words, if Phase III is negative, there won't be a Phase IV.

15 comments:

  1. Thank you, Mindy. We are finally going to get to know the Phase III BWG study tomorrow at 6:00PM. I appreciate you letting us know.

    Patricia Carter

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  2. It's important that we continue to support the WPI irrespective of the study's outcome - especially if it's negative.

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  3. How could it be positive if Science is willing to publish it after asking for a retraction of the original paper? Is there any doubt it will be negative given this?

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  4. if its negative its a cover up!

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  5. No one will know for sure until tomorrow. There's 2 possible outcomes - let's just be prepared for both.

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  6. thanks for the update. Can't wait for the results.

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  7. See NIH Project Reporter: http://www.projectreporter.nih.gov/project_info_details.cfm?aid=8178650&icde=0
    $277,500 awarded on 29th July 2011 for "OPTIMIZATION OF XMRV AND OTHER MLV-RELATED VIRUS DETECTION FOR SCREENING OF BLOOD"
    This looks like the funding for Phase 4 of the XMRV Blood Working Group's study to me!

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  8. "spiked positives."

    Assays not diagnostically validated and no pedigreed positives!

    "Several samples from about 70 different subjects were tested using at least 15 different assays."

    How many 2? And using the assays that have not been diagnostically validated! Wouldn't matter if you used 100 assays for HIV, it would still land you in jail.

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  9. It's negative. Lipkin will be final say. I really recommend patients notgetyiny overly upset over this. Science takes time. I'd wait for January or February. And please for the love of WPI don't make statements like it's a cover up. Let WPI speak for themselves and let the science speak. It makes WPI look really bad and the entire patient population look insane.

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  10. BWG is negative as Busch has know for some time

    Mulvs infect B and T cells and promote clonal expansion in B cells.Activated B cells show homing properties returning as memory B cells to the sites of initial antigen encounter.Most often this is the spleen and the gut. Hence the presence of gammaretroviruses in the blood is at best intermittent.The macaque studies show that after the acute phase even when the the vp-62 is injected straight into the bloodstream its DBA becomes undetectable by PCR after a few weeks and the antibody response disappears completely. despite not being detectable in the blood the viral DNA is readily detectable in the tissues using the same PCR assay

    transient viremia( virus in the blood) occurs upon immune stimulation by opportunistic infection or VACCINATION.This occurs with HIV as well when patients on HAART

    looking for gammaretroviruses in blood samples is brainless as being able to detect them there is quite literally the luck of the draw

    depending on the route of infection you might NEVER find a gammaretrovirus in the blood of an infected person

    There is also a sound explanation why the use of spiked VP62 to optimise a PCR assay would never be able to allow that assay to detect a gammaretrovirus in an infected person

    If anyone would like to know why just indicate that you do and I will post the explanation later

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  11. If there is one thing I know it's that i trust the WPI no matter what happens.

    They have consistently proven that they have all our interests at heart,

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  12. Suspect there's an Anonymous clown or two here trying to make patients look stupid; but if the BWG tests are negative, and moreover, you now have Silverman himself calling his work contamination, Science has the right to publish, broadcast, and defend itself, and perhaps reissue a call for retraction (where the original "call" shouldn't have been made yet). Agreed, let the WPI team speak for themselves.

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  13. @Anonymous

    Yes, there are some people (who may not be patients) who are trying to spin the facts for everyone.

    The fact is Science already are in trouble for letting Coffin and Pathak publish a paper, Paprotka et al., that mislead scientists into believing that one of the two assays in the paper was used to screen the later xenografts. In fact they left out this crucial detail, a separate assay was used. The entire paper has been invalidated by this. They cannot show the patient was not infected and cannot prove anything was created during xenografting.

    Science has no right to interfere with the discovery process. Scientists have every right to pursue the truth, they have no right to distort facts and mislead people.

    The WPI and NIC/Ruscetti, together with Alter/NIH and Lo/FDA have found a family of gammaretroviruses. Doesn't matter what Silverman does. The WPI and others found polytropics. Lo and others found xenotropics. They confirm each other.

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  14. Looks like news of it is already out:

    http://the-scientist.com/2011/09/22/again-no-xmrv-chronic-fatigue-link/

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  15. Gerwyn:
    Forget the other assays for a minute – it's the result from the WPI that are of matter. And they are anything than consistent, to put it mildly. How do you explain that?

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