IASCFS/ME - Science and the Hold on XMRV Studies

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http://www.iacfsme.org/
Science and the Hold on XMRV Studies

A positive XMRV study in CFS conducted by a NIH/FDA research team was accepted for publication in the Proceedings of the National Academy of Sciences (PNAS) but was then put on hold apparently in June, 2010. As reported in an online editorial in Nature (July 2; http://www.nature.com/news/2010/100702/full/news.2010.332.html), one scientist familiar with the issue said that the journal's editor-in-chief sent the paper out for further review after government agencies requested the publication delay. That review came back with requests for additional studies.

Stephen Monroe, director of the CDC's Division of High-Consequence Pathogens and Pathology, called the delay a "strategic pause" given the conflicting findings between the CDC’s own XMRV negative study in CFS -- also put on hold but recently published in Retrovirology --and the positive XMRV findings of the NIH/FDA group (still unpublished). Of course, we’re concerned about a full airing of the scientific data on XMRV. But it appears that the transparency and timely reporting that is so essential to science was not in evidence in this unusual government action.

Examining the Rationale of the Hold

Although the specific purpose of the hold was the subject of speculation among scientists and others, it was not clearly explained by any government official or journal editor. If the purpose of the hold was to re-examine conflicting data with an effort toward reconciling disparate findings, the approach taken here did not achieve this goal (as of this writing). In my view, if the extraordinary step is taken to delay conflicting peer-reviewed studies accepted for publication, then both studies should be held until all further analyses are done.

Once all additional work is completed, the research groups should review each other’s manuscripts. This should be followed, in one of the journals, with a thoughtful discussion among the investigators that examines the discrepancies between the studies with the goal of providing informed recommendations for subsequent research. Finally, both articles should be published simultaneously or as close to it as possible. This process has the potential to advance the science.

By contrast, the CDC article alone was published weeks ago without considering or even citing the findings of the PNAS paper. I argue that the CDC paper should have been held until its authors could respond to the NIH/FDA study when its additional work is completed. If there’s still time, I would like to see the CDC and NIH/FDA research groups have a discussion of their conflicting findings with the aim of publishing their talks in the issue of PNAS that contains the NIH/FDA study.

Implications of a Second Positive XMRV Study

Once we get past the hold period, the publishing of the second XMRV positive paper is likely to change the nature of the debate. Prior to this second positive report, the original Science paper was becoming an outlier study that could be dismissed in light of several published failures to replicate. With the new replication, the XMRV link to CFS, whatever it may be, will become an ongoing controversy that demands resolution of key issues such as the differences in testing protocols for XMRV as well as the characteristics of patient groups that are tested.

XMRV and the Ottawa 2011 Conference

Our Sept. 2011 biennial conference in Ottawa will devote a full session to XMRV. And we will put together an expert discussion panel representing different points of view about XMRV. This is the kind of scientific forum that we need to constructively address this ongoing research issue.

Fred Friedberg, PhD
President
IACFS/ME
 

George

waitin' fer rabbits
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Umm. . . no offense but isn't this kinda of a like um. . . well "duh" moment? Why do these guys always seem two steps behind? Is it because they are international? Maybe more cautious?
 

Hope123

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From what I know, the CAA's overall press release page for XMRV is hard to follow -- they don't highlight updates well and myself and a few other people had to read it a few times to see where info had been change. But I have heard that Kim McCleary talked to several officials in DC about the "hold" -- I don't know details though and someone else should confirm this.

The IACFS/ME is a small group with little support and their members are all very busy which might account for the slower press release. That being said, they should disseminate this as widely as possible now - I hope they have a media person working with them.
 
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From what I know, the CAA's overall press release page for XMRV is hard to follow
Is this deliberate? And why say the paper will be released within weeks, and then add, 3 weeks later, that it will be out later this summer?

Also, why have your upcoming webinar's at the bottom. They may link in, but you are trying to communicate to CFS patients, or are they?
 
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Originally Posted by V99
So where is the CFIDS Association on this?
ROFLMAO, Working with the gov'ment?
There is a post on the CAA's facebook page (that you have to click the CAA + Others button to see) with the link to the IACFSME position which also asks if the CAA has made a formal position statement.

The IACFSME weighs in on the hold on the NIH/FDA paper. Has the CAA made a formal position statement?
There has been no reply as yet.
 

jspotila

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So where is the CFIDS Association on this?
On July 2nd, the Association said in the CFIDS Link:

As we have since the Lombardi study was published in October 2009, the CFIDS Association of America has actively promoted properly designed studies that can determine the association between XMRV and CFS. We are working with several investigators who have such 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. The stronger the evidence is when it is published, the closer we will move to having scientific consensus on this critically important issue.
I didn't go back and check, but I'm pretty sure the Association's Facebook page included a similar statement about our support for immediate publication of both studies, and that we were advocating for that to happen.

On a personal note: I am more than happy to answer questions and consider constructive criticism of the Association's work. But I really would appreciate common courtesy instead of comments like "ROFLMAO, Working with the gov'ment? " or "Are they helping the CDC perfect that test that finds XMRV in fake samples?"
 
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The CFIDS Association has currently has the following on their facebook page:
In a recent paper on the case definition published by Leonard Jason and colleagues, they describe disordered sleep as central to CFS: "Unrefreshing sleep or disturbance of sleep quantity or rhythm disturbance. May include unrefreshing sleep, prolonged sleep (including frequent naps), disturbed sleep (e.g., inability to fall asleep or early awakening) and/or day/night reversal." What sleep issues plague you most?
Why do they not state which definition this is referring to?
 
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The statement was added to the Association's XMRV page a few minutes ago. It's a link in the "Additional Information" list.
Most people will not notice that a new link has been added. Especially when the links provided are not organised. It is not mentioned in the body of the text, and no posting has been made on the Facebook page. This does need correcting.
 

jspotila

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Most people will not notice that a new link has been added. Especially when the links provided are not organised. It is not mentioned in the body of the text, and no posting has been made on the Facebook page. This does need correcting.
There were a lot of changes today, and I know that it can be challenging to track them all. The links under "Additional Information" are listed by date of posting. The notice on the FB page that the IACFS/ME statement was posted to the XMRV info page is in the comments on the post about today's update.
 

George

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Heard and noted

Hey JSpot

No personal offense meant. I should have been more precise and less cavalier. Please accept my apology's and if you would like I'll delete the post.

That said, I do have a direct problem with the current CAA's handling of the hold's on the Alter Paper. My problem is that I hold the CAA to a very high standard and I feel that the standard has not been met by the CAA or any other CFS patient organization. My problem does belong to me and is not directed at any member of the CAA or other patient organization. However, I do feel comfortable enough in this setting to express my expectation and disappointments in the current patient advocacy groups.
  • I expect that a premier patient advocacy organization not engage in rumor's such as 'sources indicate that the paper will be released in a few weeks'.
  • I expect a premier patient advocacy organization like the CFIDS organization to present factual information if they have it and to keep quiet if they don't.
  • I expect a premier patient advocacy organization like the CAA to make strong statements against government interference in science that directly affects the health and well being of the patients they are representing.
  • I expect a premier patient advocacy organization like the CAA to make a strong stand and to organized patient based campaigns in letter writing and protesting any action that directly affect the health and well being of the patients they are representing in a negative manner.

I feel that the above criteria has not been met by the CAA and would like to express my disappointment with the CAA current handling of the situation.

Course other folks might find my disappointment to be based on faulty perceptions. That's totally cool. Folks is folks.

Now how do you remove snake eggs from behind a refrigerator without damaging the dang things. . .
 
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There were a lot of changes today, and I know that it can be challenging to track them all. The links under "Additional Information" are listed by date of posting.
Yes, it does appear that it is challenging for the CFIDS Association to communicate with the world. The links under 'Additional Information' are not all listed by date of posting. Otherwise the IACFS/ME statement would appear below the advert for the webinar and the Future medicine article, and the 'Science study', would be much further back. Anyway, a link is not good enough, when the statement comes from the IACFS/ME.
The notice on the FB page that the IACFS statement was posted to the XMRV info page is in the comments on the post about today's update.
The CFIDS Association should not be relying on members to add important information as a comment. The IACFS/ME should have its own section.