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First Direct Evidence of Neuroinflammation - 'Encephalitis' - in ME/CFS
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CDC XMRV Retrovirology Study on CFS Published

Discussion in 'XMRV Research and Replication Studies' started by KFG, Jul 1, 2010.

  1. citybug

    citybug Senior Member

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    Besides all the problems with their testing methods, this paper proves that the Reeves research criteria does not include people with CFS or ME or even recognize them.

    And their negative data doesn't support much of anything. It is not a strong paper.

    It's time to dump the Reeves definition which is wasting the small amount of CFS dollars. It was obvious when they were using foster children for research subjects. We should write congress, Sibellius, Friedman and the CDC woman at the CFSAC meeting to dump this definition and stop useless research. And to support WPI and the NEI Center as clinics for a population without adequate health care.

    This study doesn't cover the same population and doesn't appear to use positive controls. The Alter study will be more comprehensive as they back it up with more work and will blow this one out of the water, as WPI already has.

    The CDC can't find CFS much less XMRV and they've admitted it!
  2. judderwocky

    judderwocky Senior Member

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    Has anybody ever read the Martian chronicles? One of the stories is about the psychologists on mars... on mars the martians are psychic, and people appear to the other martians the way they see themselvs... if a martian imagines themselves in a red polka dot skirt, they are in a red polka dot skirt. When a human lands on mars the psychologist assumes that the human is just a delusional martian. Sure he looks different... but thats just because he thinks he's different! Eventually the human convinces the psychologist that he is actually from another planet. the psychologist, who is convinced they have both become incurably insane, then cures them both by killing the human and himself. You gotta love Ray Bradbury's insight.

    the moral of the story ? psychologists are from mars... virologists are from venus.
  3. alex3619

    alex3619 Senior Member

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    Hi Tania,

    I haven't read that comment. I both agree and disagree with you. Yes, they will try to twist it to make us sound crazy. However, no matter what we do they will do that. If we do nothing, they can say that we must know we haven't got a serious disease because we did little about this that and the other. Of course, its not because we are too damned sick ... that is all in our heads.

    We do have to be careful about what we do, but we can't give in to their position just because they will try to misconstrue what we are doing. They will often try to do that.

    I think we should also be spending more time on how we can use the latest CDC paper to show how CFS is actually two different diseases, and the other category, those with neurological symptoms etc, should have a new (old?) name. Let them play their games with chronic fatigue while we forge ahead with ME or XAND or whatever we or the researchers finally come up with.

    Bye
    Alex

  4. alex3619

    alex3619 Senior Member

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    Hi kdp

    Its more accurate to say the old guard at the CDC doesn't know what CFS is or how to find XMRV. The new guard is still untested, and given the controversy there is still a chance they will be swayed in our favour - or at least in the direction of thoughtful testable and careful science. I will believe it when I see it, but I wont give up on them yet either.

    However, we should be pushing the line that the CDC agree there are two different groups of patients, and theirs are different from us (CF, not really CFS). There I totally agree with you.

    Bye
    Alex

  5. Woody

    Woody

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    Good post. Thanks for the perspective, and appreciate the humor.
  6. Levi

    Levi Senior Member

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    Ubiquitous XMRV and Zero/Zero studies

    http://www.latimes.com/news/nationworld/nation/la-sci-fatigue9-2009oct09,0,3368993.story
    So now he is publishing yet another Zero/Zero study. The Zero/Zero studies bother me the most. Ask yourself, so a new class of human retrovirus is discovered. Take CFS completely out of the picture now for the sake of argument. Would not the DHHS/CDC want to know the prevalence of this retrovirus in the general population of the US? Where is this study? Why have they not done it? Its been years. What are they hiding and why? The WSJ can easily connect those dots, and they smell blood. . .
  7. alex3619

    alex3619 Senior Member

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    Hi Levi

    I agree. The other problem is that they can't use old blood for current prevalence, that will only show historical prevalence (presuming they could ever get their tests to work). So they really need a totally new study.

    Bye
    Alex

  8. dannybex

    dannybex Senior Member

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    I think the fact that they didn't find XMRV in either group shows that their methods were flawed, as I'm sure will be pointed out very quickly by Mikovits and her team. The CDC, as with most government agencies, isn't interested in the truth, at even local, state or federal levels. It's all about keeping things running smoothly.

    I would try not to worry. The truth will come out eventually, and remember, it will still take some time for actual replication studies, even if the NIH/FDA study backs up the WPI's.
  9. August59

    August59 Daughters High School Graduation

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    The publication from FDA/NIH, that is being withheld by DHHS, could still be released unscathed. It could be looked at and it may lead to some explaining to do for Mr. Reeves and his group. Someone up the ladder is going to say "Why was the FDA/NIH scientist able to find XMRV and the CDC scientist were not able to find even a trace of it."

    I think DHHS wants to confirm for sure what FDA/HIH has found and the shit will hit the fan when it is released. DHHS is the supreme legal being here and I would expect Mr. Reeves is doing some serious squirming. Technically, his report was released first so he could not make any changes. Knowing his cocky dumb ass he thought nothing of it. Now all of a sudden a more prestigous study with vastly different findings comes to light and BAM!!!! Daddy Rabbit (DHHS) wants to compare and have only asked Dr. Alter, FDA/NIH to confirm their findings. If DHHS does change the report Dr. Alter can surely remove his name from it for legal reasons, as well could all of the other researchers involved. If I was Reeves I would be thinking about where he's going to work next.

    One key thing is the contents of Dr. Alters paper has been leaked and if it's changed it will set off a firestorm that DHHS would not want anything to do with. There would Congressional inquirys and everything. I just think when it comes out it will sling mud in Reeves face (big time!!)
  10. dannybex

    dannybex Senior Member

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  11. Dr. Yes

    Dr. Yes Shame on You

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    Well, it was entirely surprising to a lot of scientists, including those involved in ME/CFS research.

    How terrible! :rolleyes:

    Not understandably, except for political convenience rather than the public interest.

    How do we know? How do Drs. Goff or Coffin or Singh know? That's the whole problem; nobody is privy to the original data, and possibly never will be due to this action. That is not good science, and is therefore not good for finding the truth.

    That is simply not how science works Bob, nor should it ever be allowed to be. It is a terrible mistake to believe that it should. Would you advocate that government agencies suspend publication of a confirmation study by, say, Columbia University, or Cornell, or any other non-governmental research group, just because their studies would have enormous implications? If a group of the top researchers - no matter whether they work for the NIH or the WPI - do a study, approve it for submission internally as they always do, and pass a science journal's peer review process, there is no authority or 'brain trust' that should have any oversight into the scientific process. As I and others have stated on another thread, and as at least a couple well-known retrovirologists have, this is extremely unusual and unacceptable treatment of research by the government.

    And how exactly are the 'agencies' going to 'make sure that this is water-tight'? First of all, the FDA and the NIH are the agencies in question; HHS is just the umbrella governmental department. Second, no study can be assumed to be rock solid, and if there were problems with this study nobody "higher up" would have the scientific acumen to tell. The study was already obviously approved by the relevant agencies, and by the peer review process at PNAS. The only government employees qualified to comment upon this paper are the NIH and FDA scientists themselves. The only additional reviewers necessary were the peer reviewers for PNAS.

    The WPI study was submitted to an unusually demanding amount of peer review, from what I can tell, and largely for political reasons ("Science", I suspect, guessed what they would be up against given that CFS has unfairly become somewhat of a kiss of death in the research world), but even they were allowed to publish once peer review was over. Peer review was over for the FDA/NIH study. They didn't have second thoughts. They clearly got a call from politicians, not other scientists, and now a great deal of revisionism and other forms of obfuscation are going on.

    Meanwhile, the fact that the CDC study was allowed to be published does has a major impact. The safety of the blood supply is at stake - if some 'senior officials' are truly worried about this issue then they should still be holding the CDC study as well, since that actually increases the likelihood of laxity by blood banks and of a potential threat of XMRV being marginalized. It also has the effect of delaying or discouraging new research into these issues internationally. If the XMRV threat to the blood supply turns out to be real, then suspending the positive study while allowing the CDC study to go through borders on the criminal.

    But the greatest risk is to finding the truth (or as near as we can get to it), which is the goal of science. The danger for everyone, healthy or sick, is that government officials will put pressure on their government scientists to in some way compromise the strength of their data or conclusions. This is always a possibility during extraordinary government actions. The way to avoid this is to present the study as is to the international scientific community. If the study is not water-tight, they will find the leaks. That is their responsibility. It is not the job of policy-makers who are not specialists in the field, nor is it their job to second-guess their top scientists. They can ask Alter and company "are you damn sure?", but unless the answer was "no, not really", their oversight ends there and the standard scientific process should be allowed to continue without interference.

    From consuegra:
    In terms of science and normal scientific process this would make absolutely no sense. No researcher does his own study (in this case two different sets of researchers working independently), with his own cohorts, writes a paper and submits it and then is expected to pull back and test someone ELSE'S cohort before he can even get published. That violates every relevant rule of theoretical and professional scientific protocol I can think of. It doesn't matter if it is politically expedient -- scientifically it sucks, and that's what should really matter in the search for the truth about XMRV. The initial findings must be published first, and any additional collaborations (sharing of samples, etc) should be done as a logical follow-up. But you do NOT dilute the initial study's cohort, or force them to compromise their original study design, and ultimately their resulting percentages/conclusions, in this manner. Ever. That would be like 'stacking the jury' in a court case.

    On an unrelated note, addressing a point I keep hearing in this discussion -

    Public panic, and the other possible governmental concerns that have been raised, are not as great a potential danger as is the continuing spread of infection. Just ask Marcus Conant. With HIV it was precisely this attitude that created more deaths and, ironically, more public panic, by stifling critical scientific research into the disease; it was the knowledge they gained that ended up allaying the 'hysteria'. If that lesson hasn't been learned from the way the AIDS epidemic was handled, then I don't know what else to say.
  12. Dr. Yes

    Dr. Yes Shame on You

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    P.S.

    [Don't mean to keep picking on you Bob, but your posts summarize a number of arguments that need to addressed]:

    (1) Science is not being allowed to 'work' here,

    (2) If "the truth will always win in the end" is even a historically accurate statement (which, logically, we cannot know), the problem is that it very often takes decades. I don't have that kind of time - do any of us? Now is absolutely NOT the time to sit back and trust in Fate, or in the government agencies that have thwarted research into ME/CFS before. This is the time to raise our voices and exert all the pressure we have always wished that others would. The government is just a bunch of people like us, but with their own interests; we should never let anyone have this kind of control over the search for our cure.
  13. Anika

    Anika Senior Member

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    "Round up the usual suspects"

    Remember the classic film Casablanca with Humphrey Bogart and Lauren Bacall, and an actor who plays a likeable but corrupt local police chief, whose favorite line is Round up the usual suspects? This is the pro-forma response to a problem when no real investigation is wanted, or when the goal is to divert or misdirect the attention of the police.

    In the movie, this misdirection by the police chief is what allows the hero or heroine to escape at the end. Equally, it could allow a villain or villainess to escape.

    The person who controls the cohorts used in any study in a sense controls the results of that study GIGO means garbage in, garbage out.

    Suzanne Vernons comments on the CDC-released paper are so on-target. This is the most direct criticism I have seen from her about either CDC or the other negative XMRV studies. I think her opinion will have some impact on the most important audiences scientists and journals. She knows the cohorts well.
  14. bullybeef

    bullybeef Senior Member

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    Like what has been mentioned, even if Alter 'alters' [couldn't resist] his paper, it will prove the leak was necessary, and hugely significant. And the WSJ been privy to this info means it will be very difficult for the NIH/FDA to backtrack. They will be damned if they, and if they don't!
  15. Angela Kennedy

    Angela Kennedy *****

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    Here here Doc.

    'Science' is NOT some pure, sterile, rationally self-correcting entity. 'Science' is done by scientists, who are human, and therefore subject to the same capacity for foibles as all humans, and it is thoroughly subject to structural, political and ideological forces.

    We, the people and their supporters who have been so constantly on siege from situations where ideology trumps 'science', time and time again, are not in a position to place a quasi-religious faith in people claiming 'scientific' authority.

    I desperately hope 'scientists' globally will see that this appears to be an abuse of the whole process of 'science' on which they place so much trust (and perhaps rather unscientific 'faith). However, many 'scientists', or those claiming scientific authority often appear to be quite blinkered, quite quasi-religious and irrational in their faith in scientific 'authority'. All sorts of abuses of the 'scientific process' has occurred time and time again with regard to CFS, blatantly so, without protest, apart from patients and their supporters, whose rational concerns are trivialised or subject to ad hominem misrepresentation.

    My concern is this is exactly what will happen this time.

    We need more formal avenues of objection. But if legitimised charity organisations will not speak up and register objection, what options are available? We can register objections singularly, but these can be dismissed as singularly 'ranting'.

    So, what options are open to the community?
  16. Dx Revision Watch

    Dx Revision Watch Suzy Chapman dxrevisionwatch.com

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    ME Association summary and statement (UK)

    For the record and not an endorsement:


    ME Association

    Latest XMRV study from US fails to find evidence of the virus in ME/CFS: MEA summary and statement

    Friday, 02 July 2010 09:39

    As reported on 1 July 2010 on the MEA website (Retrovirology, 1 July 2010), results from a further XMRV study, which has attempted to validate the finding of XMRV infection in people with ME/CFS, has failed to do so.

    ( http://www.retrovirology.com/content/7/1/57 )

    VALIDATION AND REPLICATION STUDIES

    So we are now in a position where four follow up published studies to the October 2009 Science paper have failed to find XMRV in people with ME/CFS. These papers can all be accessed via the MEA news archive - along with our comment at the time. A further study carried out by Professor Brigitte Huber, which was reported at the May IiME conference and failed to find any evidence of XMRV, has not yet been published. Conference report available in the MEA May news archive.

    It is important to note that these are all validation studies meaning that they are using what the different investigators believe are the best methods they have for finding XMRV. They are not using the same CFS research criteria for the choice of patients as was used in the American (WPI) study that did find XMRV (ie using people meeting Fukuda CFS and Canadian Criteria for CFS). Even so, validation studies are an important component of the process of evaluating a new scientific finding such as this.

    We currently have no results from replication studies where the same laboratory methods and same patient selection criteria are used.

    NIH STATEMENT ON XMRV +ve STUDY

    As was also reported at the same time in the Wall Street Journal (WSJ link), publication of a second research study, which appears to have found XMRV in another cohort of people with ME/CFS, has been put on hold and a statement from the group involved has been issued via the CFIDS Association of America (CAA):

    Statement from Dr. Harvey Alter, transmitted by the NIH Office of Communication and Public Liaison: "Our paper has not yet been accepted for publication. My colleagues and I are conducting additional experiments to ensure that the data are accurate and complete. Our goal is not speed, but scientific accuracy." Harvey Alter, M.D

    This information suggests that publication of these XMRV +ve results is no longer imminent.

    CAA STATEMENT

    As our colleagues in America are fully up-to-speed on the what is a fast moving story over there, we have reproduced the statement issued by the CAA.

    The link to the critique by Dr Suzanne Vernon is well worth reading because it contains some very valid criticisms about this new study, including the choice of patients involved.

    As we have since the Lombardi study was published in October 2009, the CFIDS Association of America has actively promoted studies that seek to validate and confirm the association of XMRV in CFS. We are working with several investigators who have studies under way. Publication of study data in top-flight peer-reviewed journals is essential to advancing our understanding of the role that XMRV plays in CFS, and we are actively advocating for publication of the study conducted by NIH/FDA as swiftly as possible. The Lombardi paper was reported to be under review for five months at Science, and its important to recognize that top journals enforce tight requirements on their authors.

    Last weeks unauthorized report about the NIH/FDA study by a news agency in the Netherlands disrupted steady progress being made toward publication of the data. In response to a report in the June 30, 2010 issue of the Wall Street Journal, Dr. Harvey Alter issued this statement last evening, transmitted via the NIH Office of Communications and Public Liaison: "Our paper has not yet been accepted for publication. My colleagues and I are conducting additional experiments to ensure that the data are accurate and complete. Our goal is not speed, but scientific accuracy." According to John Burklow, director of the NIH Office of Communication and Public Liaison, these additional experiments were a condition of acceptance by the journal, Proceedings of the National Academies of Science USA (PNAS), and may take weeks to complete and review. Mr. Burklow is confident that the results will be published, and stated that all the collaborators are working expeditiously, but carefully, to ensure the accuracy of their results and the manuscript. The CFIDS Association has confirmed that additional reviewers for the paper were recruited as recently as two weeks ago.

    The CDCs paper published today in Retrovirology was submitted to the journal on March 26, 2010, and accepted and published on July 1 after undergoing final scientific review by CDC scientists. According to Joe Quimby, senior press officer at CDC, additional assessment was performed after the paper was originally submitted as part of CDCs commitment to ensuring the accuracy and relevancy of the scientific information it reports. He noted that the paper published today is the same as the original submitted manuscript. No changes were made to the CDC paper authored by Dr. William Switzer, et al.

    A critique of the Switzer study by Association scientific director Suzanne Vernon, PhD, titled, Blood from a Stone, has been posted at http://www.cfids.org/xmrv/070110study.asp.

    In the months that passed between publication of XMRV/CFS studies (February-June), many people expressed concern that XMRV was being ignored, dismissed or overlooked. The discrepant findings by federal agencies have brought XMRV and CFS to the attention of the nations top public health officials and media outlets. As more information about the timetable for publishing the NIH/FDA study (and studies from other institutions that are in the pipeline) becomes available, we will rapidly share that news.

    FURTHER COMMENT IN THE WSJ

    Further comment from the Wall Street Journal, who are obviously receiving informed information from well placed US sources, can be found by clicking here.

    ( http://blogs.wsj.com/health/2010/07/01/cdc-teams-xmrv-chronic-fatigue-syndrome-paper-is-out/ )

    WHERE NEXT?

    Despite a series of 5 negative results the 'jury is still out' when it comes to drawing any firm conclusions about a possible link between XMRV and ME/CFS. And it looks as though this is going to take some time - probably until results from all the XMRV studies that have been completed, or are still underway, have been reported in the scientific journals. This may well mean 2011 rather than late in 2010.

    Retrovirologists and ME/CFS researchers will then have to review all the evidence and try to reach a consensus on the possible link between XMRV and ME/CFS and decide on where we go next.

    If it looks as though there is a definite link, possibly just in a sub-set of people with ME/CFS, researchers will then have to try and decide whether XMRV is a disease-causing virus or just a harmless passenger. If XMRV is a disease-causing virus in ME/CFS then the use of anti-viral drugs will need to be assessed in clinical trials. However, the use of anti-retroviral drug therapy would obviously have to proceed with great care given the fact that AZT can cause mitochondrial damage - see MEA website report (HIV and fatigue session) on the recent Newcastle University Symposium on fatigue research.

    ( http://www.meassociation.org.uk/ind...-school-10-june-2010&catid=30:news&Itemid=161 )


    Newcastle Symposium: HIV AND MUSCLE - ASSOCIATIONS WITH FATIGUE: Dr Brendan Payne

    Dr Payne explained that fatigue is a common problem in patients with HIV and AIDS. It does not appear to be linked to demographics (= age, sex and other population variables) or immune system cell markers. It does appear to be linked to lipodystrophy (= changes in body fat distribution caused by antiretroviral drug treatment), orthostatic intolerance, depression and sleep disturbance.

    Of particular interest is the fact that patients who are treated with antiretroviral drugs such as AZT, which almost completely suppresses HIV replication, find that this has very little effect on fatigue levels. In other words, removing the HIV infection does not remove the fatigue. So, as with ME/CFS, the question is raised as to whether fatigue is being caused by immune activation that is triggered by an infection.

    The session on HIV and fatigue also briefly covered the very important issue of muscle mitochondrial damage following antiretroviral therapy (AZT) which is related to the lipodystropy and appears to be permanent in some cases. This observation is obviously going to be very relevant if it turns out that XMRV is a causative factor in ME/CFS and clinical trials involving antiretroviral therapy take place.

    There was a short discussion on the Science paper reporting XMRV in patients with ME/CFS and results of the four validation studies which have failed to find XMRV in other cohorts of people with ME/CFS.

    On the other hand, a conclusion may be reached that XMRV is not linked to ME/CFS and further research is no longer justified.....

    ROLE OF MEA RAMSAY RESEARCH FUND

    In the meantime the MEA Ramsay Research Fund is very willing to consider UK applications relating to good quality research that will help to us to reach a satisfactory conclusion about a possible link between XMRV and ME/CFS.

    XMRV TESTING IN THE UK


    In our current state of knowledge there is no point in paying for individual XMRV testing through commercial laboratories because testing is not available on the NHS. This is not a diagnostic test for ME/CFS and a positive XMRV result is not at present a route to any form of drug treatment.

    Full MEA statement on XMRV testing in the UK

    ( http://www.meassociation.org.uk/ind...rv-testing-in-the-uk&catid=30:news&Itemid=161 )

    Dr Charles Shepherd
    Hon Medical Adviser, The ME Association
    2 July 2010

    [Ends]
  17. Dx Revision Watch

    Dx Revision Watch Suzy Chapman dxrevisionwatch.com

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  18. eric_s

    eric_s Senior Member

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    But what could we do?
  19. Bob

    Bob

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    A summary of the XMRV research, to-date, on the CAA website:

    http://www.cfids.org/xmrv/default.asp

    Here's some interesting snippets that I've taken from the CAA article:

  20. Bob

    Bob

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    Hi Dr Yes,

    Yes, OK, maybe I'm being too laid-back in my attitude towards this... I tend to have an optimistic nature about XMRV research because the evidence is so exceptionally strong... and I was pointing out that we don't really know anything about why the paper has been withheld, and so maybe it's not necessary to jump to a worse-case-scenario conclusion about all of this... but maybe it is... i don't know.

    I had an optimistic view that this paper had been withheld in order to make it more rigorous, just as the Science paper was... it is very unusual for a paper to be fundamentally changed in order for it to be accepted... But if you are right, and this is pure politics at play, and not science... if it's the case that the study been withdrawn in order for other CDC samples to be added, then obviously this is totally unacceptable to us... but that is only speculation at the moment... there's no reliable info about that... it might just be that they are just making the study stronger... I hope we find out soon.

    We've been told that the paper was withdrawn in order to 'to do extra work on it'... so maybe this is just like the WPI had to do with their study... if this is the case, then it won't be a bad thing for the study to be 'tested' before publication.

    I wasn't saying that we should sit back and do nothing... But I was pointing out that the science process will be a long and drawn-out one and that the results are not going to be released in an orderly fashion when it's related to such a massive subject as this. I agree that we should demand that the science isn't interfered with by politicians or other vested interests, and I agree that we should write to the government agencies to complain... I agree with all campaigning work... That's why I'm on this forum.

    Just to clarify, I wasn't advocating anything, or trying to justify anything... I was just offering an opinion as to how the science process works... This type of delay and re-reviewing is exactly what happened to the WPI's Science paper, and we are stronger for it's rigorous peer-review process, because it means that people have not been able to pick holes in it since it's publication... Certain members of the scientific community have tried to destroy the paper's credibility, along with the reputation of the WPI, but the mud hasn't stuck because the study was so solid... There is still serious research going on with regards to XMRV... XMRV is not being ignored.

    I said that it wasn't surprising that this paper has been withheld... I didn't say that it was right... But I did say that it could be helpful for us in the long-run, depending on why it's been withheld... My point was that, if there are enormous implications attached to a science study, then it will attract a lot of attention, and it isn't surprising that establishment figures are asking questions about it, and that they've asked for further clarification and further checks before publication... The government don't want this published if there are holes in it because of the implications... I'm not saying that this is the right process, or the wrong process, but it's not totally unusual for further checks to be placed on a high profile paper before publication.

    If people are expecting us to have quick answers with regards to XMRV research and CFS, then I think it's right to point out that this process is most likely going to take years, not months...
    And the politics involved in it means that will take longer... and it's always going to be messy... I'm just pointing that out.

    Bob

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