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

V99

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That webinar was scheduled back in June (I think). You might remember that Dr. Katz gave a CME lecture on XMRV and blood safety several months ago, and it cost over $100 per person to attend. The Association invited him to give the webinar in order to give patients access to the information for free.

On July 27th, the Association said (on FB), "The paper will be published in the Proceedings of the National Academy of Sciences (PNAS), although no date has been given by the journal. The journal is published weekly and comes out on Tuesdays. The authors expect the paper will be published "soon." That is the most recent info gvien to the Association that I am aware of, and "soon" is in quotation marks because that was what we were told.
Jspotila, can I ask where does the information come from? Is it PNAS, the DHHS, NIH, where?

Also, is that information still on Facebook? I can see something similar on the CAA website.


This is the quote that is on the CAA website:
The researchers have conducted additional experiments as requested by the reviewers and the paper is expected to be published later this summer in the Proceedings of the National Academy of Sciences.
 

SOC

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On July 27th, the Association said (on FB), "The paper will be published in the Proceedings of the National Academy of Sciences (PNAS), although no date has been given by the journal. The journal is published weekly and comes out on Tuesdays. The authors expect the paper will be published "soon." That is the most recent info gvien to the Association that I am aware of, and "soon" is in quotation marks because that was what we were told.
Thanks, jspotila! That's a very clear statement of what the CAA knows.

I wouldn't expect anyone other than a few people at PNAS to know more than that.

I don't expect the CAA to be calling PNAS every week and asking, "Are we there, yet?" There are plenty of people at CAA who know how long scientific paper publication takes. I expect that they have a very general idea about when it should be out and will let us know when they know more.
 

jspotila

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Jspotila, can I ask where does the information come from? Is it PNAS, the DHHS, NIH, where?

Also, is that information still on Facebook? I can see something similar on the CAA website.
The information came from interactions with authors and others at the FDA Blood Product Advisory Committee meeting. The statement was made as a comment on another person's post on the Association's Facebook wall.
 

V99

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Thanks for the reply.
jspotila, have you heard anything about the paper being published in September?
 

V99

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Just trying to get as good a picture of the situation as possible. Similar information coming from the authors and others at the meeting is a good thing, but we have no idea who is controlling them. The distrust is for those who have held this study back and those who have prevented ME from being treated appropriately. It's an unpleasant situation for all of us. I'm holding back at the moment, but there is a time limit to how reasonable I want to be with the DHHS.
 

eric_s

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Thanks, jspotila. It's good to see the CAA is keeping an eye on this and i hope you continue.

Similar information coming from the authors and others at the meeting is a good thing, but we have no idea who is controlling them.
I don't know if anyone could control them. Dr. Alter is probably too old and too accomplished to be scared, i mean what could anyone in the DHHS do to him? He does not need to go anywhere anymore. The other, probably younger authors might be more susceptible to pressure, but can you imagine that Dr. Alter would accept that the study is never published or published with a new conclusion, if he believes the conclusion that was leaked in June was correct? I can't.
All he would have to do is get this story to the media and that would be some sort of atomic bomb. With his CV the media would certainly listen to him. The public would go crazy if they would hear by the author of a study finding a probably dangerous retrovirus in the blood supply and in the population that there were people who tried to prevent that study from being published. The people who tried to interfere with the publication would be in big trouble.
So, if Dr. Alter wants that study published, it will be, that's what i think. For that reason i would be careful with him.
 

V99

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Firstly, the information may not be from Dr Alter. Secondly, we have no idea what the Government is thinking on this. They may actually decide to kill it. I cannot rule this out right now, stranger and more unpsetting things have happened before.

Personally, I feel quiet positive that this study will be released soon. I agree that too many people are now involved in this, and that Alter would have no reason to go along with management if they threatened him. However, under the circumstances, anyone who feels that the study will be fiddled with or blocked should also not be dismissed. I am also angry that they are choosing to make patients wait for this. Haven't ME patients suffered enough.
 

eric_s

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That the Lo/Alter study has been so effectively quashed. What are your plans y'all, if, as I strongly suspect, the study is never published at all? All complaining will do is make CFS/ME patients and organizations look like ineffectual, cry-baby whiners to the medical profession and general public.

Is one obscure study that sat on the back burner for months going to change the way mainstream western medicine treats CFS/ME? Is this "pot watching" merely flogging a dead horse?
What about the Freedom of Information Act? Would it be possible to request access to that information?
 

anciendaze

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What I have heard before is consistent with what I'm hearing now, publication is likely on August 24.
 

Stone

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:worried: I'm a little worried about the content of the study when it is published. I fear that it may not be quite as conclusive as we wish, and we will still be left in a holding pattern, summoning all our patience as we await the next study, and the next. Maybe I've just let my thoughts run away with me, but this has been in the back of my mind for a while and I'm just now allowing myself to actually think about it. I mean what if we find that what Dr. Alter said on his slide(s) is true enough but then there's something else we hadn't anticipated? I don't know, I just had to put it out there so I can relegate it back to the back of my mind again. Anybody else worried, I mean just a little?
 

Megan

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If you feel the need to do something now, you could find that statement and as a single person inquire of PNAS if that's true and, if so, what the expected publication date is. You could report here so that everybody doesn't have to write PNAS and slow down their work.
SickofCcfs,

I sent the below email to PNAS on 28 July. As yet I have received no reply and do not expect to receive one now. Perhaps a better response would be gained from a US citizen? Or perhaps, as suggested by others too much 'poking' at them has been going on. Surely I'm not the only one to have written to them.

Dear Mr. Schekman,

It has been reported in several places on the web that the XMRV paper by Dr Alter has successfully completed its second round of review and is currently awaiting publication by journal editors. Are you able to confirm that this is the case or state when the paper is to be published?

Furthermore are you able to reassure CFS patients that the most recent article has not been subject to change from journal editors due to external pressure from DHHS or other agencies. As you will understand, the peculiar circumstances surrounding the release of this paper has made patients anxious regarding the credibility of this process.

Kind regards,

Megan XXXX
Australia.
 

Megan

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On July 27th, the Association said (on FB), "The paper will be published in the Proceedings of the National Academy of Sciences (PNAS), although no date has been given by the journal. The journal is published weekly and comes out on Tuesdays. The authors expect the paper will be published "soon." That is the most recent info gvien to the Association that I am aware of, and "soon" is in quotation marks because that was what we were told.
Thanks you jspotila for clarifying the CAA statement. However, there is no reassurance in any of this that PNAS themselves will not delay the publication. There appears to be just silence on the part of PNAS at this point. Is this not of concern when it was originally reported that the PNAS editors themselves had been subject to pressure to pull the paper the first time around?

It was reported in Nature that, "One scientist familiar with the issue said that the journal's editor-in-chief, cell biologist Randy Schekman of the University of California, Berkeley, sent the paper out for further review after government agencies requested the publication delay. That review came back with requests for additional studies, the scientist says." http://www.nature.com/news/2010/100702/full/news.2010.332.html?s=news_rss

I would think it is very important that this paper is released in a timely manner prior to the XMRV conference in September. Are the CAA able to seek confirmation from PNAS on this point?
 

Wonko

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:worried: I'm a little worried about the content of the study when it is published. I fear that it may not be quite as conclusive as we wish, and we will still be left in a holding pattern, summoning all our patience as we await the next study, and the next. Maybe I've just let my thoughts run away with me, but this has been in the back of my mind for a while and I'm just now allowing myself to actually think about it. I mean what if we find that what Dr. Alter said on his slide(s) is true enough but then there's something else we hadn't anticipated? I don't know, I just had to put it out there so I can relegate it back to the back of my mind again. Anybody else worried, I mean just a little?
I concur - this would fit better with my experiences so far than the cut and dried, it's all sorted now, view most people seem to be taking (in the event that it is published) - it seems unlikely that "vested interests" are just goign to give up - they will keep stalling, keep ignoring any evidence they dont like, until they have no backing at all - which isnt going to be when this paper is published - no matter what it says
 

xrayspex

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There has been something strange going on with viral research for awhile now it seems, the more I reasearch the history of "cfs" (and HIV) the more glaring that is...

something strange happened with alters paper, and like I pointed out in a thread yesterday about le grice from nci, what he said in LA article about xmrv, does not look good in retrospect reflecting onto 2010 and his boy Alter, how did Alter get that far without LeGrice and the rest knowing?

anyway, I will be happily surprised and sheepishly admit I let my imagination go wild if it gets published this year and still looking like we would expect it to given his croatia slides....
 

eric_s

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:worried: I'm a little worried about the content of the study when it is published. I fear that it may not be quite as conclusive as we wish, and we will still be left in a holding pattern, summoning all our patience as we await the next study, and the next. Maybe I've just let my thoughts run away with me, but this has been in the back of my mind for a while and I'm just now allowing myself to actually think about it. I mean what if we find that what Dr. Alter said on his slide(s) is true enough but then there's something else we hadn't anticipated? I don't know, I just had to put it out there so I can relegate it back to the back of my mind again. Anybody else worried, I mean just a little?
Of course i'm worried, because so much depends on wheter XMRV is important for us or not. And this study might clear this up. But i don't think it will be the way you fear it might me. The study will either show an association between XMRV and CFS or not, anything else is hard to imagine.
 

SOC

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SickofCcfs,

I sent the below email to PNAS on 28 July. As yet I have received no reply and do not expect to receive one now. Perhaps a better response would be gained from a US citizen? Or perhaps, as suggested by others too much 'poking' at them has been going on. Surely I'm not the only one to have written to them.

Dear Mr. Schekman,

It has been reported in several places on the web that the XMRV paper by Dr Alter has successfully completed its second round of review and is currently awaiting publication by journal editors. Are you able to confirm that this is the case or state when the paper is to be published?

Furthermore are you able to reassure CFS patients that the most recent article has not been subject to change from journal editors due to external pressure from DHHS or other agencies. As you will understand, the peculiar circumstances surrounding the release of this paper has made patients anxious regarding the credibility of this process.

Kind regards,

Megan XXXX
Australia.
[my bolding]

Hi Megan,
My best guess is that a scientific journal of the this stature in international enough not to care where you're from. :Retro smile: DHHS, as a government agency might, I suppose.

Just speculation here -- the sentence I bolded above could be delaying the response to your email. It is not the type of question many people at PNAS could answer easily. First, there might be only one or two people who know, and they would be very high up in the authority chain, and second, it is sufficiently politically charged to require the attention of the senior editor rather than a flunky.

The questions most likely to get a prompt answer are questions that could be answered by secretaries or junior assistant something-or-others. ;) Information they can look up, like, "What is the expected publication date of...." might work. "Is this paper in your hands, awaiting publication, or is it still with the authors" might work.

It's quite possible, too, that PNAS has already been "poked" too much and is not answering this kind of email promptly. They don't ordinarily get much, if any, email about a paper before it's published, and I doubt they're set up to answer volumes of such mail. The editor and his staff already have full-time jobs and simply can't spend another 10-20 hours answering the mountains of email about one paper out of the hundreds they publish every year.

I'm not even sure the authors can get an exact answer to the question of when the paper will be published, so the best an interested bystander might get is "soon" or "this summer".

I still advocate patience -- I don't think we're outside the normal timeframe given that the paper had changes, including new testing.
 

SOC

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:worried: I'm a little worried about the content of the study when it is published. I fear that it may not be quite as conclusive as we wish, and we will still be left in a holding pattern, summoning all our patience as we await the next study, and the next. Maybe I've just let my thoughts run away with me, but this has been in the back of my mind for a while and I'm just now allowing myself to actually think about it. I mean what if we find that what Dr. Alter said on his slide(s) is true enough but then there's something else we hadn't anticipated? I don't know, I just had to put it out there so I can relegate it back to the back of my mind again. Anybody else worried, I mean just a little?
Somebody said (I wish I could remember who) that the conclusion of the paper will be the same. I think that's the biggest thing we care about. ;)

sheer speculation following:
If I hypothesize a "significant" change to the paper, I might suggest that somebody caved in to the demand that the patients be described as something other than "CFS" patients. It would still be about us, but they wouldn't use the name the CDC is hijacking for its CYA psychobabble papers. Maybe it will be about "ME" patients, or patients with "idiopathic neuroimmune disease" or somthing like that.

I kind of doubt it, though, because that, I think, would weaken its position as the first verification study of the Lombardi et al paper. They would have to very strongly emphasize in the paper and in the abstract that the patient set in both papers is the same group according to symptoms and diagnosis.

I think we're all nervous to some degree. *grin* We're like first time mothers -- we know things should go just fine, but we've been listening to all the horror stories and we know it's not impossible for something to go wrong. Our baby is going to come when it comes, there is no real reason to expect things to go badly wrong. But the inability to exactly predict what's going to happen and when and the horror stories we know make us a little insecure. Perfectly normal, I'd guess. :D
 

urbantravels

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Heck, we have a disease where it's impossible to exactly predict what's going to happen. I know that makes me more anxious than my pre-illness baseline!

PNAS is known for breaking big medical stories. This one has the potential to be VERY big. Given the choice, even if the study was all buffed up, checked and triple-checked, and ready to go now, is early August the ideal time to bring it into the world? I'm guessing not. For maximum impact (which would be a GOOD thing, remember - lots of press coverage, lots of awareness being raised in the minds of laypersons as well as the scientific/medical community) - it would be better to bring the study out when universities are back in session & people are back from vacation.

Yeah, I don't want to wait another second either. But I think the ****storm will be SO much more entertaining to watch if it happens when everyone is back at their desks.