Thursday, August 4, 2011

BREAKING THE CODES

 Blood Working Group 
Results Expected in a Month

Dr. Michael P. Busch, director of the Blood Systems Research Institute, said today in a telephone interview with CFS Central that his institute began this week to break the codes for the Phase III study of the XMRV Blood Working Group.  “We expect in the next month to preliminarily disseminate the findings,” Busch said.  The Phase III study is evaluating the specificity and sensitivity of different assays in detecting the retrovirus XMRV, first discovered in ME/CFS patients in October 2009 by the Whittemore Peterson Institute.

How the Blood Working Group plans to publicize the results will be determined later this month, when the Blood Working Group scientists have their next phone conference.  Busch offered three possible ways of publicizing the preliminary findings:  in a peer-reviewed journal; at a conference; or in a press release.

“The Working Group will have to decide whether we put out a general public announcement summarizing the findings [making sure] that it would not undermine the scientific, peer-reviewed publication. Major journals are careful about embargoing findings. We’re working on a paper, pending the findings, so that we can plug them in and submit the paper.”

However, “definitive” dissemination will be through publication in a major journal, Bush clarified.

Researchers have 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).  Several labs participated, including those at the Whittemore Peterson Institute, the Food and Drug Administration, National Cancer Institute, and Centers for Disease Control, plus the commercial labs Abbott and Gen-Probe. 

The scientists examined 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.

“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,” Busch said.

34 comments:

  1. Thank you Mindy. Good to read your news!

    ReplyDelete
  2. Thanks. I've been waiting to hear something from the Blood Working Group. This will be very important. It reminds me of last year, when we were waiting for the Lo et al. paper.

    ReplyDelete
  3. I am a person with CFS/FM and I still do not understand what this is all about. Are they still trying to say we do not have a legitimate illness? Just live in my shoes for a week and forget the test. It doesn't matter what they say. I know exactly how I feel and I may not evern "Look Sick" to you. But, what will that prove to me after being very ill for twenty something years?

    ReplyDelete
  4. Thanks, Mindy. Know many are hanging on by their teeth waiting for this one. If none of the assays find XMRV, will that be the end of it, do you think? Woe is me; so many patients have their last hope pinned on this, and Patient Advocate says it is all being shot down no matter what.

    ReplyDelete
  5. Thanks for the report, Mindy.

    Anonymous at 8:45 PM, whatever the results from the Blood Working Group, there is no way it will be the end of it. A real retrovirus has been found, using real science, and that genie cannot be put back into the bottle. This study should be no one's last hope. Whatever this government study shows, there has never been any proof of contamination or other problem with the Lombardi 2009 SCIENCE study, and the discovery of XMRV/HGRVs cannot be buried the way Elaine DeFreitas' discovery was buried in 1990. The only way to deal with the Lombardi 2009 study is to prove or disprove it scientifically, by replication, and this has never been done. So it is a mistake for anyone to have their last hopes pinned on this Blood Working Group Study. The WPI science is solid, and eventually the scientific establishment is going to have to deal with this fact.

    Patricia Carter

    ReplyDelete
  6. Cheers Mindy, much appreciated.

    patients want the truth, we know we have a persistent viral infection that progresses through our bodies over time.

    We know this because we live with it, XMRV has been the only contender that pulls al the strings together.

    ReplyDelete
  7. If this comes up with good results I wonder if things will move faster or if they'll still pull the "waiting for Lipkin's study" line

    ReplyDelete
  8. "Woe is me; so many patients have their last hope pinned on this..."

    I just don't understand why "so many" patients have put all their eggs in this basket. Is it because of Hillary Johnson's flawed theory that ME/CFS must be caused by a retrovirus?

    People are getting better, maybe not completely recovered, but some are doing that to. On the flip side, only a handful have improved on antiretroviral drugs, and many have gotten worse because the drugs are so toxic.

    This isn't AIDS, and in general it isn't "infectious". Look and find out what others are doing to improve (and often according to Deckoff-Jones, they're improving by avoiding doctors), and maybe you just might get better too.

    ReplyDelete
  9. This isn't AIDS, and in general it isn't "infectious".

    It isn't? And what is your source of information to proof that it isn't infectious?

    Definition of Infectious [ɪnˈfɛkʃəs]

    1. (Medicine) (of a disease) capable of being transmitted Compare contagious
    2. (Medicine / Pathology) (of a disease) caused by microorganisms, such as bacteria, viruses, or protozoa
    3. (Medicine) causing or transmitting infection
    4. tending or apt to spread, as from one person to another

    What part of infectious(according to you) isn't applicable tot this virus?

    Don't you think they would not put so much research in it, especially the BWG, if it wasn't infectious?
    Are you not aware of the fact that many partners and children of a positive tested person also test positive?

    I would, if I were you, read up about what AIDS really is and what causes it. I think that if you do you realize that you can easily replace the word AIDS by ME.

    PS: I would love to read your explanation of how exactly Hilary Johnson's theory is 'flawed'.

    ReplyDelete
  10. Lol ok marcia. What do you think it is?

    ReplyDelete
  11. Annoyed by DeniersAugust 5, 2011 at 9:18 AM

    Thanks, Mindy!

    No, you're right of course, Marcia. It's caused by flying saucers. Who needs further research or treatment?

    ReplyDelete
  12. to Marcia: "this isn't AIDS and in general it isn't infectious" ...

    No, this isn't AIDS, this is ME.
    But how can you be so certain ME isn't infectious? Scientists are still figuring this out. People are advised by the CDC in the US and in many other countries not to donate blood! Mothers with ME often pass "something" on to their children. What is that all about in your opinion? People getting ME after a blood transfusion or an operation? All the Outbreaks that have occured?

    Maybe you're confusing ME with vague "chronic fatigue" conditions?

    You also say that many ME patients get better after "avoiding doctors"?
    Where did you get that information from?
    People with genuin ME do not get better in most cases. Doctor or no doctor. Most of them stay the same and count themselves lucky if they find meds to control some of the debilitating symtoms. Another group does deteriorate as time goes by. And a very small group gets better yes. But even then they have to live through this horrible illness for decades before getting to a "better" stage. From bedbound to housebound over a period of 10 yrs. Do you count them as the ones who are getting "better"?

    Do you even know that ME can be fatal in some cases? Heartfailure, cancer, organ failure (Sophia Mirza), major seizures ...
    And do you know that the general lifespan of ME patients is about 20 yrs shorter than life expectancy of the general public?

    Marcia, I do not think that antiretrovirals are THE solution at the moment. But if you're as sick as most of us are, you would give it a try if you could. You would really try everything!

    Perhaps you're comparing lemons with oranges. I don't know. But if you're talking about ME, you're obviously not aware of the often life threatening complications of this terrible chronic neuro-immune-endocrine illness.

    Going to doctors is really not one of our favourite things we do with our limited energy. But it's necessary because living through this disease if often so unbearable that if we don't find any symptom relief from certain meds the only option we can think of is to end it all. And seeing most of us really love life in general, we fight, we search, we try whatever we can and yes, we go and see ME specialists hoping they can make life a bit tollerable again.

    This search, this fight for life is something that should be admired if you really understand what is takes to keep going.
    You telling us we should better "stop" and that we will get better then ... well, it's a slap in many people's faces.

    I'm praying for the day I can stop seeing my ME specialist or any doctor for that matter.
    But at the moment that is just not an option.

    ReplyDelete
  13. Marcia, why do you suppose you possess the ability to make sweeping generalisations as to the state of people's hopes.

    The press has been littered with arrogant generalisations of ME patient motives and beliefs all week and that hasn't gone down well either.

    There's a difference between putting one's eggs in a single basket, and supporting the most promising current research to its logical conclusion and blocking the attempts to bury it early.

    ME patients shouldn't tolerate capitulation.

    The 2009 science paper made waves. Blood was banned, and deafening noise, much of it with intent to dilute cried out across the media.

    If another paper, another theory popped up which had an equal effect, I don't think you'd find interest in it wanting.

    Your non-cited theory about the efficacy anti-retroviral interventions hold little water either. In time targeted drugs could be developed as they have been for HIV/AIDS patients. Efficacy takes time and it takes brave souls.

    On top of that, it can't even be shown empirically that the 17 million people lumped into the same diagnosis even have the same illness.

    Take your generalisations elsewhere. Don't try to tell people what something isn't when nobody knows either. You should drink a cup of your own pseudo-agnosticism.

    ReplyDelete
  14. The science shows human gammaretroviruses are associated with ME. There is no other egg. We have a winner, now let's stop them hiding it and killing people.

    ReplyDelete
  15. Sweet, Marcia. It's not just Hillary Johnson and Judy Mikovits, retroviruses have been found in ME patients going back to the early eighties. It's the only hypothesis that accounts for all the etiology of the disease. Check out this thread http://www.mecfsforums.com/index.php/topic,8708.0.html

    There are only a handful of ME patients on anti-retrovirals. Dr. Deckoff-Jones is one. From being housebound, she is now working again, at her practice in Hawaii and at the WPI in Reno.

    ME is an Acquired Immune Deficiency disease. Check out the research, B cell involvement, cytokine abnormalities. ME is infectious - outbreaks occur in confined communities, Lake Tahoe, Royal Free, Dr Bell's Lyndonhurst cohort, dozens more examples. It occurs in families. Just because the information has been swept under the carpet doesn't mean it's not there.

    ReplyDelete
  16. OMGosh!! Mindy and everyone, this is huge when you combine it with this other HUGE piece of news (where are the press releases galore?!) from of all places the FDA itself:
    http://www.fda.gov/biologicsbloodvaccines/scienceresearch/biologicsresearchareas/ucm127327.htm

    They are actually looking into vaccines as vectors for retroviral infection of humans, including XMRV! And stating it publicly. Incredible. THis needs to be in every newspaper nationwide.

    ReplyDelete
  17. thanks, mindy, for your continued good work. -- rivka

    ReplyDelete
  18. @ Marcia,I don't go to doctors. Gave that up along time ago. I've had the illness 17 years and have never "gotten better". I also have no mental or personality disorder, Been tested more than once back in the days. Oh and I've worked the whole time so you can't call me lazy either. Guess what though I have an HGRV and have paperwork to prove it. Don't worry you don't have to be so afraid of the retrovirus as there are many of us out here. Either you will have it or you won't. Plain and simple. Actually I'd rather know what has ruined my life rather then be labeled as crazy.

    ReplyDelete
  19. Wildaisy:
    "whatever the results from the Blood Working Group, there is no way it will be the end of it. [...] The only way to deal with the Lombardi 2009 study is to prove or disprove it scientifically, by replication, and this has never been done."

    You just gave a very good argument for why negative results in this phase of the Blood Working Group SHOULD be the end of it. After all, the WPI have been given the chance to exactly replicate their methods and results on a cohort that they themselves defined as positive for XMRV and that is large enough for the purpose of replication (it's about the same size as the Lo cohort).

    Therefore, I really don't know what you could argue against negative findings. Yes, you could say that perhaps the blood wasn't collected correctly or that a conspiracy was in place, but that would be equally true of this exact replication attempt that you demand.

    As it stands, there is really no reason to dismiss this finding while demanding a "proper" replication. What exactly could this exact replication add to the field when the WPI are unable to replicate their own results using freshly collected blood samples that they themselves have designated as positive for XMRV?

    ReplyDelete
  20. The WPI replicated their methods in the UK study. The one they conducted with the NCI.

    Fact is anything could happen to samples before and after the WPI have them. So this study is again only one study.

    RRM why don't you learn about science before trying to rewrite the scientific method. Replication is a fundamental concept. Stop trying to pursuade others it is not with crazy ideas.

    ReplyDelete
  21. We would all like to see this UK study, and the study finding XMRV in Autism (which is not a psychiatric disorder and should be moved to neurology too) - but these studies have been censored, a telling example of the dirty campaign to cover up the truth.

    There has been a ramping up of the tactics used to destroy the deFreitas/Bell/Cheney et al finding of a retrovirus in 1991, which had been suspected since 1985 and remains the only explanation that accounts for the acquired immune dysfunction and the multiple chronic infections. They called it non-HIV AIDS in the 80s.

    The unvalidated 0/0 negative studies using a VP62 clone on people with "fatigue" to create the perception of consensus is not science, its politics and scientific malfeasance. The expected diversity of the XMRV/PMRV sequences are being added to GenBank, patients have an antibody response, and those on ARVs are improving, though more needs to be done and would be if the science was allowed to proceed. AIDS drugs are so safe they are now being given to healthy HIV+ people as prophylaxis!

    The research on XMRV will continue because it has been scientifically established as the third human retrovirus after HTLV and HIV, and the dirty and desperate campaign to destroy the connection to M.E. make it abundantly clear what is going on.

    ReplyDelete
  22. @anonymous

    Thank you for making my exact point, as any other replication study would have the same problem as this study (in your words: "anything could happen to samples before and after the [replicating scientists] have them"). Why would you would you then accept the conclusions from a negative (exact to the letter) replication study?

    And I know about science, but thank you for your friendly advice. If exact replication is such a fundamental concept in virology in the way you see it, it would surely would be no problem for you to point me in the direction of a few "true replication" attempts?

    The fact that you (or anyone else in the world) cannot do that, fundamentally undermines your position. Exact replication in the way you apparently envision it, has never been performed by Mikovits, Alter, Lo or the Ruscetti's. There are only two options: either they are very bad scientists who failed ninth grade science classes too, or your definition of replication study in this context is off.

    Oh, one more of my "crazy" scientific ideas is that people should be willing to adapt their views when evidence becomes available that contradicts the hypothesis they support. I for instance will be perfectly able to adapt my views when the WPI will be able to reliably differentiate between patients and controls in the BWG and Lipkin studies.

    Will you? Or will you only accept the results if the results support your position? Wouldn't that be rather unscientific of you (or did I remember that wrong too)?

    Despite my sometimes rather sarcastic way of putting this, I wish you all the best, and I sincerely hope scientists will find the cause/cure of ME/CFS soon.

    ReplyDelete
  23. How would we square a single viral cause with seven CFS subtypes discovered by Kerr using affymetrix gene arrays?

    Is that one virus with several other viruses acting as accomplices? Or seven stages of disease? Or seven different diseases being diagnosed as CFS of which one is XMRV? Or maybe a bit of each?

    ReplyDelete
  24. Thanks a lot Mindy. Your effort is appreciated!

    ReplyDelete
  25. Anonymous said on August 7, 2:10 AM: "The expected diversity of the XMRV/PMRV sequences are being added to GenBank".
    Really? I hope that's true. If you are still around here, can you tell us where you've heard that and when they will be accessible? Thanks

    ReplyDelete
  26. oh dear has anyone seen Jamie Deckoff Jones new blog? she doesnt sound very hopeful at all! Especially about the XMRV Blood working group - sounds like she might no something and i dont think it sounds like good news?

    ReplyDelete
  27. I guess this BWG press release has a big impact on where do we go from here with XMRV...although we still need to wait 2 years for Lipkin results, this previous results from BWG might even stop or influence on the Lipkin study if it came negative... can somebody tell me if this is the case?

    ReplyDelete
  28. Thanks for the news, Mindy!

    BWG has the results and are not releasing them for another month? Maybe I am naive to the ways of science but this seems to me to be irresponsible. If this is just the 'ways of science' then they need to change. If I kept information vital to public health secret for a month as a lawyer, I would probably be disbarred. How come these supposed servants of public health are not held to the same standard?

    ReplyDelete
  29. It's the 30/8, so almost a month after this article was posted. Still no results... They should be released anytime now, until there has been another delay (wouldn't be the first time). Now i will read Jamie Deckoff-Jones' blog that was mentioned here. I hope the interpretation posted here in the comments was not correct...

    ReplyDelete
  30. Whatever the truth about XMRV will be (and we don't know yet if the BWG study will provide an answer to that), i think there's one thing we shouldn't do. No offense meant to Jamie Deckoff-Jones and i wish her all the best, but i think we should never accept that things are going slowly and we might even have to keep this illness. No way! Funding for ME/CFS research is ridiculously small and we are millions. Next May 12th is still over half a year away, so we would have enough time to prepare. In the case that it would look like XMRV leads nowhere and there might not be rapid progress we should then do on May 12th what we should have done a long time ago. We should all go out on the streets and public squares, with family and friends, as many people as possible, and finally show the world we exist and demand the help we deserve. We are not second class citizens and you can't just abandon us and condemn us to a life of being sick where almost everything is denied to us that others are enjoying every day. I know we are not well and this is hard to do, but it's possible and it's the job of our organisations to make it happen. Where i'm involved, i will participate in organising this, if it doesn't look as if we will be getting real help soon. We don't have much to lose, so i really don't see what is holding us back.

    ReplyDelete
  31. This is not about science any more, it's about politics.

    The FDA and may others have essentially confirmed HGRV's are found in these patient populations.

    It's just a matter if the governments and special interests controlling the upper level management are going to continue with their spin campaign and contamination fairy tail.

    We all know people there is a team around like RRM who have a big fat cushy pay check trying to keep everybody sick and without treatment.

    ReplyDelete
  32. Do you know how the progress is going on this? It's been a month...

    ReplyDelete
  33. Jace, this is not an "Acquired Immune Deficiency" disease, it's a disease of immune DYSFUNCTION. Huge difference, something that you, Jamie, Mindy and Hilary just don't seem to understand.

    And how's that workin' for ya?

    ReplyDelete

Comments are welcome and moderated for appropriate content.