ME Association summary and statement (UK)
For the record and not an endorsement:
ME Association
Latest XMRV study from US fails to find evidence of the virus in ME/CFS: MEA summary and statement
Friday, 02 July 2010 09:39
As reported on 1 July 2010 on the MEA website (
Retrovirology, 1 July 2010), results from a further XMRV study, which has attempted to validate the finding of XMRV infection in people with ME/CFS, has failed to do so.
(
http://www.retrovirology.com/content/7/1/57 )
VALIDATION AND REPLICATION STUDIES
So we are now in a position where four follow up published studies to the October 2009 Science paper have failed to find XMRV in people with ME/CFS. These papers can all be accessed via the MEA news archive - along with our comment at the time. A further study carried out by Professor Brigitte Huber, which was reported at the May IiME conference and failed to find any evidence of XMRV, has not yet been published. Conference report available in the MEA May news archive.
It is important to note that these are all validation studies meaning that they are using what the different investigators believe are the best methods they have for finding XMRV. They are not using the same CFS research criteria for the choice of patients as was used in the American (WPI) study that did find XMRV (ie using people meeting Fukuda CFS and Canadian Criteria for CFS). Even so, validation studies are an important component of the process of evaluating a new scientific finding such as this.
We currently have no results from replication studies where the same laboratory methods and same patient selection criteria are used.
NIH STATEMENT ON XMRV +ve STUDY
As was also reported at the same time in the Wall Street Journal (WSJ link), publication of a second research study, which appears to have found XMRV in another cohort of people with ME/CFS, has been put on hold and a statement from the group involved has been issued via the CFIDS Association of America (CAA):
Statement from Dr. Harvey Alter, transmitted by the NIH Office of Communication and Public Liaison:
"Our paper has not yet been accepted for publication. My colleagues and I are conducting additional experiments to ensure that the data are accurate and complete. Our goal is not speed, but scientific accuracy." Harvey Alter, M.D
This information suggests that publication of these XMRV +ve results is no longer imminent.
CAA STATEMENT
As our colleagues in America are fully up-to-speed on the what is a fast moving story over there, we have reproduced the statement issued by the CAA.
The link to the critique by Dr Suzanne Vernon is well worth reading because it contains some very valid criticisms about this new study, including the choice of patients involved.
As we have since the Lombardi study was published in October 2009, the CFIDS Association of America has actively promoted studies that seek to validate and confirm the association of XMRV in CFS. We are working with several investigators who have 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.
Last weeks unauthorized report about the NIH/FDA study by a news agency in the Netherlands disrupted steady progress being made toward publication of the data. In response to a report in the June 30, 2010 issue of the Wall Street Journal, Dr. Harvey Alter issued this statement last evening, transmitted via the NIH Office of Communications and Public Liaison:
"Our paper has not yet been accepted for publication. My colleagues and I are conducting additional experiments to ensure that the data are accurate and complete. Our goal is not speed, but scientific accuracy." According to John Burklow, director of the NIH Office of Communication and Public Liaison, these additional experiments were a condition of acceptance by the journal, Proceedings of the National Academies of Science USA (PNAS), and may take weeks to complete and review. Mr. Burklow is confident that the results will be published, and stated that all the collaborators are working expeditiously, but carefully, to ensure the accuracy of their results and the manuscript. The CFIDS Association has confirmed that additional reviewers for the paper were recruited as recently as two weeks ago.
The CDCs paper published today in Retrovirology was submitted to the journal on March 26, 2010, and accepted and published on July 1 after undergoing final scientific review by CDC scientists. According to Joe Quimby, senior press officer at CDC, additional assessment was performed after the paper was originally submitted as part of CDCs commitment to ensuring the accuracy and relevancy of the scientific information it reports. He noted that the paper published today is the same as the original submitted manuscript. No changes were made to the CDC paper authored by Dr. William Switzer, et al.
A critique of the Switzer study by Association scientific director Suzanne Vernon, PhD, titled, Blood from a Stone, has been posted at
http://www.cfids.org/xmrv/070110study.asp.
In the months that passed between publication of XMRV/CFS studies (February-June), many people expressed concern that XMRV was being ignored, dismissed or overlooked. The discrepant findings by federal agencies have brought XMRV and CFS to the attention of the nations top public health officials and media outlets. As more information about the timetable for publishing the NIH/FDA study (and studies from other institutions that are in the pipeline) becomes available, we will rapidly share that news.
FURTHER COMMENT IN THE WSJ
Further comment from the Wall Street Journal, who are obviously receiving informed information from well placed US sources, can be found by clicking
here.
(
http://blogs.wsj.com/health/2010/07/01/cdc-teams-xmrv-chronic-fatigue-syndrome-paper-is-out/ )
WHERE NEXT?
Despite a series of 5 negative results the 'jury is still out' when it comes to drawing any firm conclusions about a possible link between XMRV and ME/CFS. And it looks as though this is going to take some time - probably until results from all the XMRV studies that have been completed, or are still underway, have been reported in the scientific journals. This may well mean 2011 rather than late in 2010.
Retrovirologists and ME/CFS researchers will then have to review all the evidence and try to reach a consensus on the possible link between XMRV and ME/CFS and decide on where we go next.
If it looks as though there is a definite link, possibly just in a sub-set of people with ME/CFS, researchers will then have to try and decide whether XMRV is a disease-causing virus or just a harmless passenger. If XMRV is a disease-causing virus in ME/CFS then the use of anti-viral drugs will need to be assessed in clinical trials. However, the use of anti-retroviral drug therapy would obviously have to proceed with great care given the fact that AZT can cause mitochondrial damage - see MEA website report (HIV and fatigue session) on the recent
Newcastle University Symposium on fatigue research.
(
http://www.meassociation.org.uk/ind...-school-10-june-2010&catid=30:news&Itemid=161 )
Newcastle Symposium: HIV AND MUSCLE - ASSOCIATIONS WITH FATIGUE: Dr Brendan Payne
Dr Payne explained that fatigue is a common problem in patients with HIV and AIDS. It does not appear to be linked to demographics (= age, sex and other population variables) or immune system cell markers. It does appear to be linked to lipodystrophy (= changes in body fat distribution caused by antiretroviral drug treatment), orthostatic intolerance, depression and sleep disturbance.
Of particular interest is the fact that patients who are treated with antiretroviral drugs such as AZT, which almost completely suppresses HIV replication, find that this has very little effect on fatigue levels. In other words, removing the HIV infection does not remove the fatigue. So, as with ME/CFS, the question is raised as to whether fatigue is being caused by immune activation that is triggered by an infection.
The session on HIV and fatigue also briefly covered the very important issue of muscle mitochondrial damage following antiretroviral therapy (AZT) which is related to the lipodystropy and appears to be permanent in some cases. This observation is obviously going to be very relevant if it turns out that XMRV is a causative factor in ME/CFS and clinical trials involving antiretroviral therapy take place.
There was a short discussion on the Science paper reporting XMRV in patients with ME/CFS and results of the four validation studies which have failed to find XMRV in other cohorts of people with ME/CFS.
On the other hand, a conclusion may be reached that XMRV is not linked to ME/CFS and further research is no longer justified.....
ROLE OF MEA RAMSAY RESEARCH FUND
In the meantime the MEA Ramsay Research Fund is very willing to consider UK applications relating to good quality research that will help to us to reach a satisfactory conclusion about a possible link between XMRV and ME/CFS.
XMRV TESTING IN THE UK
In our current state of knowledge there is no point in paying for individual XMRV testing through commercial laboratories because testing is not available on the NHS. This is not a diagnostic test for ME/CFS and a positive XMRV result is not at present a route to any form of drug treatment.
Full MEA statement on XMRV testing in the UK
(
http://www.meassociation.org.uk/ind...rv-testing-in-the-uk&catid=30:news&Itemid=161 )
Dr Charles Shepherd
Hon Medical Adviser, The ME Association
2 July 2010
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