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Mikovits interview states the FDA will confirm WPI findings in a Sept publication

Discussion in 'Media, Interviews, Blogs, Talks, Events about XMRV' started by Stone, Aug 16, 2010.

  1. shrewsbury

    shrewsbury member

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    Hey George,

    Do you know where Frank Ruscetti said this? I completely missed it. All I know of is the NIH/FDA paper, Alter/Lo, paper that was presented at the Zagreb Blood COnference

    Argh - so much info.

    thanks so sb
  2. Otis

    Otis Señor Mumbler

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    I think that the results of the Alter-Lo paper (George, I think there's just the one unless you know something I don't) are just a foregone conclusion in many circles. Publication of it will be anti-climatic for most of us, not to mention the scientific community. It's the splash it will have on the general public that remains.

    Based on what we've heard from Andrea, Annette, Judy and Vince (because we're all on a first name basis :) ) it seems things have progressed a step or three past the Alter-Lo paper to immune profiles and candidate treatments which may go beyond ARVs (probably a few details to work out here). That seems like lots of really big news to come down in a day. The Alter-Lo statement seems like the smallest piece of 'news'.

    I'm stalking the paper because I want to read it, not because I doubt the results. It's taken me a long time to get to that level of confidence but I kinda hear an avalanche rumbling. Get out if the way CDC. And pull out your erasers and redefine CFS again.
  3. Sunshine

    Sunshine Senior Member

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    I thought originally there were meant to be two replication studies also. FDA and NIH.
    It's interesting Judy Mikovits didn't say NIH at all, and just FDA.

    Perhaps the WPI are talking of a study we are not aware of at all, or the european study?
    http://www.meresearch.org.uk/research/projects/xmrvsweden.html

    The CDC are desperate to redefine CFS into subsets and ignore XMRV. This will be hard as the CDC's CFS is an imaginary illness hiding a neuro immune disease. Critically, the CFS biomarkers they talk about are in people with XMRV which the CDC says is not in CFS patients. Ergo the CDC are limited in using genes and cortisol as a CFS marker rather than an infectious single agent. A biospychosocial approach could theoretically argue 'stress' causing gene changes, moving the spotlight away from XMRV. This is exactly what the CDC is and will do from now on. The CDC's perogative is they must not find or allow a single infectious agent in people with CFS, and XMRV is just that.

    The CDC pulled the CFS website, redesigned it with toned down language of how serious CFS is (and unique features we all know happen IN CFS - which will turn out to be XMRV causing these unique features) and stated XMRV is not found in CFS. They did this thinking we'd all go away and to disinform the world's media who will (in time) decend on the CDC's CFS website when the XMRV news breaks. Whilst WPI are designing a test to prove that CFS has a unique biomarker that will be evidence of XMRV causing CFS, the CDC are reporting people with exposure to common viruses feel worn out 6 months after...(like we didn't guess that at high school). All vague and unspecific, unlike XMRV which is specific. CFS by nature is vague and unspecific, this is the diagnostic criteria for it and why it was 'invented' a long time ago.

    In the shadow of XMRV it's as if the CDC have hit the 'rewind time' button on the research remote control whilst going 'la la la' in a pair of headphones whilst the WPI start making real strides in science.Trez bizarre. If it wasn't so tragic for people with CFS, the politics taking place in the CDC would make a very good movie into how to not manage a disease. Lots of ego's and posturing and desperate acts to hold onto power all at the expense of public health. Thankfully, science is bigger than any individual and the CDC will eventually have to call it a day, if within 24 months the WPI have proven that XMRV causes CFS due to CFS patients having a unique immune profile that only XMRV could cause.. This finding, plus evidence of clinical improvements using ARV's would mean the CDC would then be so at odd's with science, patients could actually sue them for publically advising their CFS is not due to XMRV, and that doctors should not run immune function tests. Which is what the new CDC website on CFS is actually saying, believe it or not.

    A couple more replication studies (note in HIV it only took one replication study) and the evidence is clear that the WPI are the moral victors in the battle of the CFS biomarkers. (There's a good title for Cort). CDC's biomarkers will be not related to XMRV and WPI's will. Either way, the CDC cannot be realistically thinking the next equivalent causative agent (XMRV) of the next AIDS (CFS) has been discovered by the WPI , and they can go a different direction.

    Imagine if they'd done that with HIV and continued looking at non HIV people who are immune supressed stating that AIDS isn't linked to HIV and using a manufactured illness and call it HIV that doesn't require a retrovirus. If the CDC aren't careful they will be doing just this, or indeed, already have been for 25 years. Someone somewhere has been a very naughty boy at the CDC. I wonder who ordered it all those years ago back in the 1980's? ME (Myalgic Encephalomyeltis) was a neuro immune disease since 1969, but when the rate of ME exploded, CFS has to be created in order to silence the general public and doctors who would come into contact with infected XMRV people, who were told they had CFS. Quite a brilliant master plan if you think about it, but it has to have been planned.

    Bring on the replication studies for XMRV and real change. Like Cort said, all this will eventually mean we can discuss science on here with no arguments or upset at all. Science is what phoenix rising started off as. A science website. Back to the source. :)
  4. Rivotril

    Rivotril Senior Member

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    Why would Judy say that a paper (FDA) appearing in september finally confirmed their paper, if there was another paper (NIH/alter/PNAS?) which would do the same thing before that date.
    makes no sense. even less sense by just saying it, without a source, like it was a well known fact for ages

    it would be great but please post these things only if you are quite sure and with a source, imho
  5. CBS

    CBS Senior Member

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    SB,

    I heard the same thing George heard but I can't tell you where I heard it (you know, it's a 'men in black' kind of thing). Suffice it to say that 'it' was in the presentation whose name (or at least the name of the AV person in charge of distribution to the research community) shall not be spoken. As for the timing of publication and whether or not he meant two papers or two institutions, I don't know (but I do know he said two papers).
  6. Rivotril

    Rivotril Senior Member

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    Two Reno scientists, who last year discovered a new infectious human retrovirus they linked to chronic fatigue syndrome, said Monday that their findings have been replicated and confirmed by the U.S. Food and Drug Administration.

    did you read the article in RGJ??? please don't post all this kind of things without doing any homework at all
  7. Esther12

    Esther12 Senior Member

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    I'm not sure, but think you could be right.

    It's so difficult to judge these matters clearly, especially when those actively involved in research are likely to know more than us.
  8. VillageLife

    VillageLife Senior Member

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    confusion.
    they should never of blocked this paper in the first place. its so bad for our health to deal with all this.
  9. Sunshine

    Sunshine Senior Member

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    I agree villagelife, but sadly politics comes before morals. We are just a tiny speck of dust compared to the gold bar in the safe that is given as another Christmas bonus, if us lot are silenced - for good. The CDC plan on doing this by digging their heels in over 'not one infectious agent', as this exludes anyone with XMRV to be called a CFS patient. It also mirrors the views of Professor Simon Wessely (UK NHS) and Bill Reeves of the CDC. If there is not one infectious agent, anyone is welcome to the party, meaning the people with neuro disease become the minority and CBT and exercise and other 'theories' (child abuse) can flourish in the majority. Remember Professor Simon Wessely stated in a newspaper article, that XMRV didn't explain childhood truama, a quite odd comment to make as retroviruses don't have to explain anything. This showed the desperate, desperate acts of holding onto 'theories' whilst the threat of their 'pet' CFS trots off into the next door neighbours garden and starts feeding on ARV's and not freudian theories.

    Money and power are tremendously seductive, even if one was originally a scientist with good intentions. Status in CFS 'experts' (proponents of the psychiatric view of CFS) has been garnered in individuals over decades and these people face looking like simpletons via the discovery of XMRV. They were so panicked they even announced (predicted by ESP?) that XMRV would never be found in CFS, a real howler and rather obvious that the CDC would thus (literally) not find XMRV which is exactly what happened. We all knew it would happen as the result was pre announced.

    To allow a XMRV positive replication CFS paper to be published before doing a hatchet job to save your own career, would not be possible in an organisation that invented CFS and reduced the diagnostic criteria to a now proposed, 'fatigue and one symptom'. Imagine how XMRV could become 'fatigue and one symptom', if that happened, XMRV would cease to exist which would mean the CDC could carry on doing what they've been doing for nearly three decades by using a label called CFS. Make the neuro immune illness (caused by XMRV) invisible, de-legitimize the patients, and do not spend money on finding the cause. If no cause is ever found, no one is to blame. If no one is to blame, the people responsible of infecting potentially 17 million people get away with it.

    WPI was never part of the plan, they got in the way and appeared out of nowhere and ruined the wedding cake of the psychiatric profession and insurance industries marriage together. CDC/associated agencies blocking an XMRV paper is a tiny irritation compared to what they have done and will plan on doing next to CFS patients. The next big punch, is the reclassificaiton of CFS as a mental disorder with immune overlays. (There are immune overlays in Schizophrenia for example and still no test). The poor people who are XMRV negative will be absolutely destroyed. It's vital these CFS people get rediagnosed with new illnesses and escape the label CFS because, a storm cloud and a planned fatal lightning strike is brewing.

    More and more scandellous and ludicrous things will happen to us all who have the label CFS. If the CDC didn't care about us in 1986, do you think they care about us now when untold numbers of people have died from XMRV? WPI are literally going to be life savers and go down in history as such. All of us are witnessing medical history it's quite an extraordinary happening what we are experiencing since october 2009 and the SCIENCE paper showing XMRV was found in CFS.

    If there was ever a time to be an investigative journalist, now is the time.
    http://www.cfscentral.com/

    One day we will climb out of our exhausted bodies back into the one's we used to have that worked and think, did that really just happen?
  10. Wayne

    Wayne Senior Member

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    Hey Otis,

    This is exactly my take on things. I've not read this whole thread, as my poor brain just doesn't have the ability to parse so many words. But it seems much of this parsing is missing what I feel is the main point, which is: "That seems like lots of really big news to come down in a day."

    Regarding whether it was appropriate for some of this information to be leaked... I'll just say that my gut tells me it was the best thing to do at this time (I'm not very good at parsing words :Retro smile:). Even though WPI may not be making perfect decisions at all times (nobody can), I have to say that I trust them implicitly when it comes to looking out for our interests and well being.

    After watching the interview with Annette and Andrea, and now reading this article, I'm really hoping to make it to the grand opening in Reno on Saturday (OMG, 300 miles one-way!). It feels all the more historic and consequential for all of us.

    Best Regards, Wayne
  11. urbantravels

    urbantravels disjecta membra

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    Two papers would certainly explain the confusion over pub dates - and the weirdish wording of how the paper is described in the newspaper article. They may have expanded the scope of the original research so much that they split up the paper in some fashion.

    My my, the anthill has certainly been stirred up this morning.
  12. Mark

    Mark Acting CEO

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    Bingo! Nice one George. :D I'd give you the whole box of doggy chocs at this point, but it wouldn't be good for you.

    This was actually my first guess when I read Mikovits' quote and thought carefully about the exact words used, and considered what assumptions I might be making! I thought I'd wait and see if anybody else thought of that possibility. If I have learned nothing else from the WPI, it is to check the wording carefully and beware going to war with my own assumptions :) Remembering the answers to questions like the "they all came from clusters" myth...it really does help a lot to read only the words that are actually on the page...;)

    So: A paper in September will report confirmation of the WPI results; but that one will likely be either a supplementary follow-up to Alter's work, or a separate study (eg one NIH one FDA). This makes more sense, given everything that has been said.

    Although Alter has performed further experiments, and this was a requirement of the reviewers, one need not assume that those further studies need to be part of the published study. The published study - today? still time? - or next Tuesday, could even be the original publication that was ready to roll in May - with appendix, say, adding notes on whetever follow-up was needed.

    The September publication could be the details of the follow-up work, itself currently still needing to go through a hoop or two to be worked up into a full paper, and consisting more explicitly of a validation of the Lombardi findings, not merely a confirmation of the XMRV/CFS association.

    Megan: thanks for your brilliant posts. Help Is On The Way, eh? :)
  13. LaurelW

    LaurelW Senior Member

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    Thank goodness! This is the most excitement I've had all day. (can you tell I don't get out much?):sofa:
  14. Sunshine

    Sunshine Senior Member

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    Rivotril. I don't appreciate your unnecessary brusque tone. Yes I did read the article in RGJ, thanks to Cort posting it for us all to read. Did you read what I wrote? Please read it again. I said I thought that the FDA replicated the study but there may be another from the NIH. I thought this as this had been suggested and believed on here and in the CFS community in general.

    Maybe you simply assumed I came to this conclusion from the RGJ article?
    I assumed the RGJ article supported the possibilty of two studies, by not mentioning the NIH.

    Note, I did not state there were two studies.

    Last time I did my homework [that you say I failed to do], the FDA stood for Food and Drug Adminsitration and not the NIH, National Institute of Health? I am allowed to use the word ''I thought'' before writing a comment on Phoenix Rising as people's views here are not an exam that needs to be graded or marked. You may find that the word 'I think' or 'I thought' is a commonly used english phrase that means the person is not quite sure if they are sure. Which is why I used those words to convey this. It's very hard to be sure about any breaking news research in CFS, and so we come together here and discuss precisely because, we aren't sure. Why you feel the need to lambast me so I don't know.

    Please refrain from posting such intolerant messages to me in the future. As far as I am aware this is a public discussion forum provided by Cort for people who are sick, not a university debating society where people are picked up on the slightest indiscrepancy. Ironically in this case, it is you who has assumed I meant something equally as I too assumed the possibility of two studies in the pipeline too. This doesn't bother me whatsoever, you are free to make mistakes as am I. None of us are perfect.

    This is a friendly happy place, lets keep it like that by being courteous and polite to each other rather than marching up to people and poking them. As I said originally, I thought there were two studies, FDA and NIH. See? This is not saying there are two studies.

    Thank you for your kind consideration over this pointless matter.
  15. ixchelkali

    ixchelkali Senior Member

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    Why? I'm not arguing the point, I just didn't know that a replication study would need to be replicated. How many times?

    It's sounds from what some of the researchers (Ila Singh, the Blood XMRV Research Working Group, Judy Mikovits, etc) are saying that at least some XMRV research is already moving on.
  16. Sunshine

    Sunshine Senior Member

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    This is an interesting point here.

    Please correct me if I'm wrong, but I'm quite sure HIV was confirmed as an infectious disease after 1 replication study and 1 proven case of person to person infection via blood transfusion?
  17. ixchelkali

    ixchelkali Senior Member

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    Cranky, much?

    I think the tension is getting to all of us. We sure seem to be getting testy, quick to give and take offense. I'll sure be glad when we get some good hard news instead of these little snippets and teasers. I like to think that once things aren't so up-in-the-air and suspenseful, and start moving forward, we won't need to keep sniping at one another.

    In the meantime, maybe we could cut each other some slack and try to work at keeping our hackles down.

    Whether it's one study or two, published this month or next, "leaked" wisely or unwisely, let's not lose sight of the fact that there's good news ahead. There's some solid science being done. Let's be happy about that!

    We don't have to all join hands and sing kumbayah together, but maybe we could relax, lighten up and smile a bit. :sofa:
  18. Cort

    Cort Phoenix Rising Founder

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    My two cents - Annette Whittemore said several positive studies are on the way. One of these, I think for sure, is going to the UK InvestInME-WPI study utilizing an independent laboratory. There was always some confusion about the positive FDA/NIH study (studies?). My recollection is that two independent labs, one in the NIH and one in the FDA, had confirmed the findings. I suppose they could have been part of one paper; the CDC paper employed several labs to back up its findings.

    In any case for me the main message is the confidence pouring out of the WPI. They know what they know and they feel they've gotten over the hump - that XMRV's first big test - post-the Science paper has finally after 8 rather agonizing months has been passed. XMRV is for real and that changes the landscape for CFS. The Science paper opened up the door, this finding cracks it wide open and if it is proved to be a major factor; well, I imagine you'll have one of the biggest single redefinitions of an illness in medical history - and we'll be right in the middle of it.

    How do you go from ignored, controversial, really unfunded disease to a disease characterized by only the third infectious human retrovirus in existence? Whether or not you have CFS that is such big news! That just doesn't happen. If it all turns out it's gotta be the medical story of the decade. All of a sudden a million or so people in the US are found to have a retrovirus - that's astonishing!

    Here's my prediction - if XMRV is found to play a major role in a signficant number of ME/CFS patients it will also show up in the other mysterious NEID's. If it plays a major role in them then you truly have a paradigm shaking pathogen; a pathogen causing distress across a large segment of our society in different ways. I think it could redefine how researchers look at disease.

    Maybe someone better will know but I don't there another pathogen that does that (other than HIV). Is XMRV the chronic illness form of HIV; ie is it the retrovirus that causes different kinds of chronic illness (rather than out an out death).

    Of course we are a long way from that - we need to see what other disorders it occurs in and to see how much of a factor it is. Dr. Mikovits immune 'biomarker' suggests its a major factor. The potential is just eye-popping.
  19. Cort

    Cort Phoenix Rising Founder

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    I got that from Dr. Komaroff who said it would be one positive study and that it would need to be replicated. I followed up that sentence with one suggesting that its very possible that it already has been - in the form of other positive studies on the way.
  20. markmc20001

    markmc20001 Guest

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    "Mikovits said they also have new, unpublished data concerning the retrovirus, XMRV, that could lead to treatment of Chronic Fatigue Syndrome.

    “We have immune system profiles and we can tell by the immune system how the XMRV is doing the damage,” she said. “So we could have a diagnostic test to follow clinical treatment and show that people’s immune systems go back to normal. That’s the latest data that’s really amazing. That’s what we’re after.”

    That data will be published by the end of the year, probably in a clinical immunology journal, she said"

    light at the end of the tunnel! Thanks to the WPI for moving the ball foward.

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