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FDA/NIH Paper will be published

Discussion in 'XMRV Research and Replication Studies' started by Mindy Kitei, Jul 9, 2010.

  1. V99

    V99 *****

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    I think the CDC ignored the HHS and published, unlike those involved in the NIH/FDA study. Vincent Racaniello in his last podcast did say they don't pay any attention to their bosses.

    Hopefully, this will play into our hands, with Alter's study being as infallible as the 'Science' paper.
  2. dannybex

    dannybex Senior Member

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    But someone (sorry can't remember who) on another thread about a week ago said this is precisely what Mikovits and Lombardi had to do as well. "Additional experiments" were requested at the last minute, before the paper was finally accepted for publication.

    ???

    ETA: Basically...what Jerry said. :)
  3. SunnyGal

    SunnyGal Senior Member

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    If the NIH/FDA paper was asked to perform additional experiements, would they have had time to do that already or in the time before the paper is now supposed to be published? Don't experiements usually take longer?

    Sunny
  4. dannybex

    dannybex Senior Member

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    Well...we don't know precisely when they were asked to do the additional experiments, nor when the paper will be published, but that's a good question. Perhaps the person who posted about the Science paper having to go through this might be able to give a time frame.
  5. dannybex

    dannybex Senior Member

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    Hi Muffin,

    I don't think we'll ever get the justice we expect from the CDC. Not saying that we should forget what's happened, but just don't think we'll ever see 'fairness' in that regard...ever.
  6. V99

    V99 *****

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    I forget who reported it, but the extra reviewers were brought in about 3 weeks ago I think.

    These extra reviewers had nothing to do with PNAS, but were demanded by the HHS weren't they?
  7. Rafael

    Rafael XMRV+ Member

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    "Place your bets everyone, the clock is ticking. "
    I came here to post my conspiracy theory (but now I think I like George's better - fits memory of large organizations). Anyways here's mine:
    The CDC is an emperor with no clothes - they don't have the ability (now or EVER) to follow WPI's formula.
    That is what they are most ashamed of. That they have done nothing, that they are incapable of doing anything since the WPI paper and the threat to society that it poses.
    So they bought some handy-dandy XMRV Virus detectors from the local supplier (see the thread on XMRV Urine test which is sold in packs of 24 in Ontario, Canada but only to researchers).
    Maybe it's one supplier that supplied all the other negative studies. (its like SYSCO silently suppling all the fast food chains with exactly the same ... uh .. food).
    And they found zero XMRV in people. The cohort was a sloppy mistake. It makes no difference if you can't even find the 4+% in general population that has been found by WPI, German lung tissue, Japan, Altar.
    They knew this and still wanted to get their study out - ideally a bit before the Altar study comes out and grabs all the spotlight and hopefully all anyone remembers is that at least the CDC at least TRIED looking for it (they calculate).
    Note that the CDC study was submitted for approval in MARCH (things looked much different in March)
    Their timing got a bit messed up with the Alter study leak. Maybe they can't think clearly with all these eyes and commenters and investigative reporters on their case. (my thanks to all of them).
  8. Bob

    Bob

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    I got the impression that PNAS was leant on by the HHS to make sure that this study was rigorously peer reviewed.
    I read that PNAS then brought in extra peer reviewers who decided that 'extra experiments' were needed...
    These 'extra experiments' could be very straight-forward and easy to carry out, depending on what exactly they are. It could be as simple as double-checking that the virus that they found was not an existing known human exogenous virus, or a human endogenous virus, or a mouse virus (contamination), which wouldn't necessarily involve very much extra work. It sounds like it was quite a simple bit of extra work if the paper is to be published in a couple of months.
  9. SOC

    SOC Moderator and Senior Member

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    Here's a suggestion: Look at the calibre of the journals these papers a published in. While the journal rating is not necessarily an indicator of the quality of a given paper, it does reflect the amount of care the journal puts into making sure the papers are of a high quality. See http://en.wikipedia.org/wiki/Impact_factor for some basic explanations and, just past midway down the page, the top ten science journals by several ranking systems. Science is in the top ten of all of them, PNAS usually follows not too far behind. You don't see Retrovirology there and you sure as heck don't see PLoS One there.

    The CAA reports that using the ISI Impact Factor, Science's rating is 29.78, PLoS ONE is not even rated, BMJ ranks 12.827, and Retrovirolgy ranks a sad little 4.6.

    Science and PNAS have a lot invested in producing the top quality papers. Reviewers are actually reviewing the papers (as opposed to giving them a quick read), and suggesting improvements.

    Speaking as a one-time reviewer of research papers for journals, asking for a few (hopefully simple) more experiments is not necessarily suggesting that the paper is inadequate. Sometimes a reviewer will suggest a few more experiments, based on his/her professional experience, that would strengthen[/ the paper. The authors can choose to do those experiments or not.

    I don't know this all played out with Alter's PNAS. I'm just suggesting that it's quite plausible that reviewers, finding the paper perfectly sound, and knowing that it was being called into question, suggested a few simple experiments that would cement it's position. Alter et al may have been not only willing, but eager to spend a few weeks to slam and lock the door in the CDC's face.

    It's also possible that the reviewers were unsure about the quality of the paper and asked for more tests. I don't think that's the more likely situation under the circumstances.

    The following is my speculation based on experience, but I know nothing about the specific circumstances of the PNAS paper. Generally speaking, if a paper needs are serious rework of it's experimental results, that work could take months. If the authors are advised to do some clean-up or strengthening experiments, it would more likely take a few weeks. A reviewer suggesting something to strengthen, rather than verify, is not likely to suggest something that would be a huge undertaking.

    Ordinarily this process would take place during the normal review process, the extra month of work would be fitted into the publication schedule and no one would raise an eyebrow. Apparently some of that happened with the Lombardi et al paper.

    It's odd that this second review took place after the journal was in galleys, but given that the CDC questioned the paper, it's no big surprise to see PNAS, with it's reputation, ask for a relatively straight-forward further review, and for the reviewers to suggest experiments that would strengthen the paper. To us, this delay is scary; to PNAS it's just a brief delay and a shift of the paper to the next publication cycle. They're probably pissed at having to do the galleys again, though. ;)

    The real oddity, in my opinion, is that the CDC should call the paper into question at this stage in the process.

    I said when the delay was announce that we would see the Alter et al paper in August (the next publication cycle probably). I'm standing by that prediction (for the moment). ;)
  10. V99

    V99 *****

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    I heard 3 weeks, so my guess is the 28th ish.

    What exactly are Galleys?
  11. Sasha

    Sasha Fine, thank you

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    When a journal accepts a paper for publication, it tidies it up for grammar and typos, and formats it ready for printing in the journal and prints a copy of the formatted text - the galley proofs - to show the author. The author checks the galley proof against their original text as a final check to make sure that errors haven't crept in during the editing and formatting stage.
  12. V99

    V99 *****

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    Thanks Sasha.

    I thought it was something like that.
  13. George

    George waitin' fer rabbits

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    The three fold nightmare of the NIH/FDA paper publication

    The publishing of the NIH/FDA paper is going to be a nightmare for the government health agencies. I'm going with a long delay and put the publication and subsiquent press release for the second or third week of August. Here's why. . .

    Nightmare number one. Once they release the paper(s) then they have the very logical problem of banning CFS patients from donating blood. Remember right now we are only "strongly discouraged", however, after the paper(s) are release the question will come up in the media of "why aren't these people banned from donating blood?" I'm sure that media personnel as well as congressmen and scientist will not want to risk themselves, a family member or friend contracting XMRV. Since the paper(s) will show strong correlation between CFS and XMRV.

    Hence, press release banning CFS persons from donating blood. This ban can only be proclaimed by the FDA. FDA did the paper so inquiring minds are going to expect that the FDA is going to issue a proclamation banning CFS patients from donating blood. Blood needs drop slightly after the summer vacation period so I think that a press release for blood donation ban will happen after school starts. The DHHS is nothing if not practical. (grins)

    Nightmare number two. Everybody is tired hence, everybody thinks they might have Chronic Fatigue. (come on you know it's true!) Hence, everybody is going to want a blood test to see if they have a virus that is making them tired. Right now I've only seen paten information for one serology test. Either the the WPI/VIP group is going to make so much money they can just all retire next year or the DHHS is going to have to make a deal with one of the groups that has developed the serology test and license it all general labs. The public will demand it.

    Nightmare number three. How the hell do you force feed information that doesn't exist yet about a virus that is only now being studied to a nation of doctors that don't even believe in a condition that they are unwilling to diagnose. (really big drooling eye ball crossed grins)

    I'm so glad I just get to sit back and watch the implosion. (grins)
  14. jimbob

    jimbob ME/CFS84-XMRV+

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    I don't like the word galley having anything to do with our study!!!!!!Everything has me paranoid now!LOL
  15. V99

    V99 *****

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    Sit back and chew on a bone, George. Getting a doggy basket to make myself comfortable.
  16. judderwocky

    judderwocky Senior Member

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    exactly... they stopped it at print was my understanding... which is a big slap in the face to the peer review process

    http://www.virology.ws/2010/06/30/publication-of-xmrv-papers-should-not-be-blocked/
  17. Otis

    Otis SeƱor Mumbler

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    I'd like to know the day the word hits Wall Street so I can make a little of my lost wages back...

    So that's how we get Dr. Reeves back. Make him pay for all the tests for the people with "Chronic Fatigue" who don't have a physical illness. We'll call it Reeves Disease - uh no, Syndrome, there's something like 3 million of them ;)

    Isn't getting a test validated and ready for the millions with Reeves Syndrome going to take months, at a minimum?
  18. George

    George waitin' fer rabbits

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    LOL - that's awsome Otis! So anybody who is not XMRV + has to get tested for Reeves syndrome? Eeeeegads that could take decades! (Snort)
  19. usedtobeperkytina

    usedtobeperkytina Senior Member

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    I think we need to take note that Science mag wanted WPI to drop the CFS as part of their paper. But they refused.

    Now, if as reported, the FDA / NIH study is positive, in whom are they seeing the higher figure? The answer is CFS patients. And surely that is the way the FDA / NIH paper will say it.

    So, if the plan is or will be for CDC to say, "That's another disease, not CFS," it will fail. Thanks to WPI for insisting that CFS be included in publication, the news media will report it as "virus in patients with CFS". In fact, it is already the case. Google XMRV, and up pops Wikipedia with link to CFs in first paragraph. Second website is WPI, and they use "CFS."

    Wall Street Journal has "Further Evidence of XMRV in CFS?" So the history has already been written in just the last nine months. We may get a new name, and some may be left in CFS who are not positive. But the link in the terms between CFS and XMRV will not be erased anytime soon.

    If CDC wants to put out that message, they will have to go against the other researchers, doctors who see their CFS patients test positive and the news media.

    Tina
  20. ixchelkali

    ixchelkali Senior Member

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    I Agree.

    I agree...with all of you. Alternately, in 5 minute intervals.

    First I believe that all will be well soon, then that they're out to get us and we're doomed, then that some of them are out to get us but that better science will win out, then that no one's out to get us, they're just incompetent, then that actually WE'RE out to get THEM, then that the long nightmare is almost over, then that good science will win out but no one will care, then... on and on, all day long.
    :eek::Green hat::D MY HEAD IS SPINNING!!!

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