WHERE ARE THE FDA AND NIH XMRV STUDIES? 5 August 2010 - It is TIME

[Angela Kennedy]

I don't think Levi is being arrogant. Unfortunately for him, experience has been bitter. As we all know history can be a great educator, we ignore it at our peril.

Yep. ESPECIALLY in ME/CFS.

 

[eric_s]

The way i see it is that CDC is currently still ending up how they wanted things.. we are still (along with XMRV) shrouded in controversy which will put off many researchers from being involved. WPI hasnt got any extra funding etc etc. They are still hoping it all goes away and we still arent clear from it all yet. I still feel no sense of safety from the research till backing papers from others are published and believed. For all we know that paper backing WPI may end up coming out tampered with, thou we are told otherwise.

"a strategic pause"

Cast enough doubt on it.. and who will believe it, things will be the way they always have been even thou studies out showing we have some physical issues going on, we still were be seen as psychriatrict patients. They have got away with it for many years, so why not cant they continue to get away with it... I believe the whole thing was planned.. i believe hey planned to delay Alter and then post their own study. A government agency acting so bias and going to such dirty tricks.. should be being investigated!!! Esp if the one running the CFS section is obviously biased when it comes to the cause of CFS.

Well, in the end the WPI holds the key to this. Even if the other studies come out negative, if the WPI produces credible positive results this will not go away. But they have to produce them. We have the power to fund them, if needed, our number is big enough. Even though i don't see why they should be the only ones able to find it. If it's there, others at least after some time have to be able to reproduce it. And there are other groups that definitely want to find it.

 

[V99]

If the paper comes out, with the same results pre interference. The next attack will be on whether it causes disease. We have to be ready to fight for serious investigation of this. The name, as others have pointed out, will then be under attack. The CDC are already making moves to claim they were never studying this disease. They were and we will remind them and the Government of this.

 

[Levi]

Inside information

Why would I have inside information? And if I did have it, it would stay that way. I am just connecting the dots in concluding that the Lo/Alter paper will never be published in a manner that replicates/validates the WPI Oct. 2009 Science article.

The folks with inside information are people like Dr. Monroe at CDC. See what he has to say about the XMRV/CFS connection on Mindy Kitei's blog:

http://www.cfscentral.com/

These are the words of a bureaucrat that knows the Lo/Alter paper has been spiked (OK, in my humble opinion). He appears to be enjoying the dismay of the CFS community and thinks he is being cute by toying with Ms. Kitei and providing non-answers to her questions.

He says CDC has found XMRV in prostate cancer patients and is about to publish this research in order to establish that the recent zero/zero CDC/CFS article is valid.

If the CDC is about to publish yet another CDC/XMRV paper, don't you think the top dogs at the NIH would have let them know the assays they are using are bogus? This is all being managed at top government levels, don't you think? And the top government levels surely know what is going on with the Lo/Alter paper, at least by now. They are not going to keep shoveling coal in the boiler room if they know the front cars of the train have jumped the track. Use some logic. And logic will tell you that the Lo/Alter paper has been de-fanged.

And when it comes to XMRV studies, Klimas is almost finished with her study of Gulf War patients and XMRV, so NIH may be running damage control and working the timing on that.
http://www.veteranstoday.com/2010/07/16/will-gulf-war-veterans-be-tested-for-xmrv/

Nancy Klimas, MD says:
August 3, 2010 at 9:51 am
Actually my group has sent identical blinded samples (35 GWI/35 matched controls) to 3 different XMRV expert labs, and we are waiting for the last group to send in the results before unblinding. Dr O’Leary of VACO was quick to respond to this request – I actually sent the samples out in January. But science does take time, and it is better to careful and correct than fast. If there is anything there you can be sure a larger study will follow. Our group is also working with CFS in veterans and non veterans. I have a CFS/GWI clinic in the Miami VAMC so you can be sure that our group remains very motivated to find results that will result in treatments. Keep an eye out for our genomics work, we have some very cool research underway to better explain the mediators of the illness.

If this Klimas work comes up with even a hint of a Gulf War Syndrome/XMRV connection, it will light a match under the bonfire. Until now, CFS patients have been disorganized and very easy to marginalize. It will be much harder to convince the general public that war vets are a bunch of sissy hysterical neurotics.

Personally, I don't care about the criticisms from sick and unhappy patients here, and I don't relish robbing anyone of hope. I am merely keeping my ear to the ground, and my take is that things are about to get ugly in terms of the XMRV/CFS/ME connection. My main point is, instead of preparing for a big celebration party, there should be a coordinated plan B just in case I am correct.

 

[SOC]

Angela,

We've been here and done this before. You don't like the way I talk to you and I don't like the way you talk to me. That's not going to change. We appear to be a conversational pair that is best kept apart.

Frankly, these discussions of ours are neither productive nor entertaining. You've had the last word on the current issue and I'm willing to leave it that way because I'm not interested in an ongoing argument. In fact, I'm willing to avoid every conversation you're involved with if it will help avoid more arguments. I'm just not interested. It ends now.

 

[Rrrr]

can someone tell me (i can't read this whole thread, sorry) WHO is holding up the NIH/FDA paper at this time? is it the NIH or the PNAS? please send me a private message, if you can!!

best,
rrrr

 

[V99]

Supposedly it is PNAS.

Time will tell, so staying hopeful. But it was the DHHS that put it on hold, not PNAS. I am repeating this to send a signal to them that we cannot be fooled into thinking they didn't do it.

 

[Rrrr]

thank you for this info, V99!!!!!!!

you say that supposedly it is PNAS that is holding it up, but in reality it is the DHHS?

 

[V99]

Sorry, no PNAS have it now.

I was only referring to who had actually asked for the hold .

 

[SOC]

can someone tell me (i can't read this whole thread, sorry) WHO is holding up the NIH/FDA paper at this time? is it the NIH or the PNAS? please send me a private message, if you can!!

best,
rrrr

The latest info we have is that the paper is "at press" at PNAS. Based on my (not recent) experience, that would be consistent with normal scheduling -- once the extra tests were requested.

There are those who don't believe the statement (from CAA, I think) that the paper is at press. There are those who don't believe this is consistent with normal scheduling. You'll have to decide what you believe since we don't have a statement directly from PNAS.

 

[Megan]

He says CDC has found XMRV in prostate cancer patients and is about to publish this research in order to establish that the recent zero/zero CDC/CFS article is valid.

This happenned with Imperial College (ICL) too. Thanks to an FOI request by someone to ICL we know they were using a different assay for their prostate samples, and prseumably they are looking at a different tissue too. I expect it will be the same with the CDC. So I don't see how they can draw any conclusions about their zero/zero CFS blood studies from what they might have found in prostate tumors with different assays.

If anything the prostate finding flies in the face of their zero/zero studies. If they acknowledge XMRV is real because it is in prostate cancer, then that means XMRV must be out there infecting an unknown proportion of the population. Therefore it should be showing up at something above zero in the blood studies. So the more zero/zero they find the more it looks like their assay is simply missing it.

 

[Levi]

Megan,

I agree with everything you say. It is a classic psych lobby tactic to rush the research paper out to counter the CFS/ME microbialists, and then try to clean up the mess after the fact with cloudy follow-up research. There is plenty of XMRV prostate cancer research already in the pipe without CDC's help, they are just doing it to gain the talking point that they can actually find XMRV with their assays.

Its transparent what they are doing, and if it is not a conspiracy, then it would be hard to deny that they at least have an agenda to steer CFS research into the psych realm and away from any infectious disease aspect.

(major snippage) Therefore it should be showing up at something above zero in the blood studies. So the more zero/zero they find the more it looks like their assay is simply missing it.

 

[V99]

The latest info we have is that the paper is "at press" at PNAS. Based on my (not recent) experience, that would be consistent with normal scheduling -- once the extra tests were requested.

There are those who don't believe the statement (from CAA, I think) that the paper is at press. There are those who don't believe this is consistent with normal scheduling. You'll have to decide what you believe since we don't have a statement directly from PNAS.

Just to be clear. I don't think people are questioning the CAA on this, they don't trust the DHHS. After all, they put the paper on hold, when it was already in press. It wasn't PNAS.

 

[eric_s]

How long would you say a paper is at press? What exactly does "at press" mean? To me it sounds as if everything (review, galley proof, etc.) has been done and it has been decided when it will be published.
I have no idea but if the paper is published every tuesday, i'd say it should be out in 2 weeks the latest.
What do you think?

 

[V99]

It could be tomorrow

 

[eric_s]

I didn't dare to say that just keeping my fingers crossed

 

[V99]

Don't blame you

 

[SOC]

How long would you say a paper is at press? What exactly does "at press" mean? To me it sounds as if everything (review, galley proof, etc.) has been done and it has been decided when it will be published.
I have no idea but if the paper is published every tuesday, i'd say it should be out in 2 weeks the latest.
What do you think?

My best guess for publication is (and has been for a long time) mid-late Aug. My money right now is on 31Aug, but I won't be surprised to see it 2-3 weeks earlier or later.

 

[Sasha]

How long would you say a paper is at press? What exactly does "at press" mean? To me it sounds as if everything (review, galley proof, etc.) has been done and it has been decided when it will be published.
I have no idea but if the paper is published every tuesday, i'd say it should be out in 2 weeks the latest.
What do you think?

In the context of an academic journal, "in press" means "accepted for publication". It doesn't mean "at the printers" (disappointingly!). For some journals, the gap between being accepted and being published can be months and months.

However, journals have the option of fast-tracking important papers and I would expect a journal that comes out weekly to be able to shove something in at pretty short notice. That's why I would expect to see the Alter study in PNAS very soon - it's an important paper, they're under pressure to publish because of the fallout from having delayed it, and they're a weekly journal.

I'm assuming "at press" (which I've never heard of) is a typo or alternative term for "in press", but I could be wrong.

Anyway, soon!

 

[Esther12]

It's strange, but I've found myself getting more doubtful about XMRV just because there's been no positive news for a while. I really want to see this paper get publicly poured over.

If they'd found contamination/error in the further tests I'd expect some word of this would have leaked out, so I'm expecting it to still be positive. It will be interesting to see all the details though.