FDA/NIH XMRV paper ON HOLD

taniaaust1

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The danger with allowing government agencies to work this out behind closed doors is that the CDC or their higher-ups could pressure the other group into editing (or, far less likely, even pulling) the positive study. To believe that government scientists are immune to pressure by the government is naive. It would be a mistake for us to relax and trust the government to do the right thing when experience tells us they are more likely to do the opposite. I think the best thing for us to do is put public pressure on the DHHS to allow the release of the FDA/NIH study (in its original accepted form) now; writing to the DHHS, to Congressional representatives, and attempting to get media coverage on this story could only help, in my opinion.
nods.. bye, bye original studies. We may end up getting a heap of tampered with studies.
 

Marco

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"So, being in possession of a paper which clearly states that you found no evidence of XMRV in patients and healthy controls, plus were unable to detect even known positives, and that evidence was emerging that you needed to use specific methods and look in particular places, would YOU submit the paper for publication?"

Its only fair to add to this that, according to Mindy Kitei's sources, CDC failed to detect XMRV in samples which were independently tested as positive by another lab. Which of course, doesn't rule out the possibility that the other lab was wrong, unless the samples were deliberately infected.
 

taniaaust1

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Yesterday I had a strange thought that the FDA/NIH would come back with a statement saying that they messed up and that they did not find XMRV as first noted. So today I see that the FDA, NIH, and CDC studies are on hold. Am I surprised that the CDC did not find XMRV? Nope. The CDC is STILL playing games with CFIDS and XMRV and I guess they decided (by their PR/Marketing people) that it was least destructive to them to come out as negative on XMRV rather than positive.

As I have said elsewhere, it doesn't matter anymore what the CDC says about XMRV, CFIDS or really anything at all -- the CDC's credibility is long gone now on all fronts. As others have suggested there have been the WPI, CC, NCI, FDA and NIH findings of XMRV as well as individuals having their own tests done and coming back as postitive. I think all those orgs and people outweigh the stupid/corrupt CDC by a huge margin.

We probably do need to keep track of all people who tested postive for XMRV, their location, the test/test org, date, etc. to use that as fuel against the CDC and those that have a vested interest in not letting XMRV be seen/known as disabling/deadly as it is. Apparently an aggressive form of prostate cancer isn't enough to prove XMRV. So that means that those that have tested positive need to make it known (not their names, just locations) and for all of us to scream and make it known that WE ALL KNOW this is politics and not science.

The Feds may well be terrified of the "findings" in the blood supply (AABB) plus the positives of the above oranizations. They may be trying to figure out how to keep the public (here/abroad) from getting hysterical and going after the CDC and other Fed health orgs with pitchforks. They also have the political problem (as seen by those with even a little background) that the CDC is yet again playing dangerous games with CFIDS and XMRV. So it probably will take them time to figure out how to lessen the damage done by the positive findings as well as the politically motivated negative CDC finding. Not a job I would want.

Below are the names and email addresses of the NIH Director, FDA Commissioner, and CDC Director. I think it is time to email them all and tell them that not only the CFID sick are aware of the games being played out but also the public as well. We need to beat on them and ensure they know they are being watched. Also time to spew the game playing of the CDC over the past 30 years across the Internet everywhere you can think of including emailing the media. (see/cite www.oslersweb.com WHY speech). I am sure the media would be interested in this game going on right now between three Federal health organizations involving a deadly cancer-causing virus that has most likely has been in the nation's blood supply for a good three decades and the science/medical documents not being released for public dissemenation. WHY would they be witholding these scientific/medical studies if there weren't very serious government implications involved? Let's ensure the public knows this is going on now and that the public is the one being damaged. So again, email the NIH, FDA and CDC top folks with gracious emails. Ask WHY they are withholding scientific/medical studies from release to the public. Ensure Dr. Frieden (CDC Dir) knows we all are aware of the on-going games played by his organization. And hit the media HARD with this one. It stinks of something very rotten and dangerous to us all. (I have also placed info on the FDA org since that has not been on this website before and we need to know what they do and how they are structured. The FDA also plays a role in blood products.)
--- NON-AMERICANS - EMAIL THEM AS WELL. WHAT HAPPENS IN THE US AFFECTS WHAT HAPPENS IN YOUR COUNTRY TOO -----

1) National Institutes of Health (NIH)
Dr. Francis S. Collins, NIH Director francis.collins@nih.gov 301-496-2433

2) OFFICE OF THE COMMISSIONER, COMMISSIONER OF FOOD AND DRUGS (FDA)
Margaret A. Hamburg, M.D. (Commissioner of Food and Drugs) margaret.hamburg@fda.hhs.gov

3) Centers for Disease Control and Prevention (CDC) http://www.cdc.gov/
Thomas R. Frieden, MD, MPH ftdh@cdc.gov
Director, Centers for Disease Control and Prevention
Administrator, Agency for Toxic Substances and Disease Registry


-------------------------------------------------------
FDA AND DR. HAMBURG BACKGROUND INFO - FYI (They also are involved in blood products)
http://www.fda.gov/default.htm
Margaret A. Hamburg became the 21st commissioner of food and drugs on May 18, 2009. The second woman to be nominated for this position, she is an experienced medical doctor, scientist, and public health executive.
As the top official of the Food and Drug Administration (FDA), Dr. Hamburg is committed to strengthening programs and policies that enable the agency to carry out its mission to protect and promote the public health. Strengthening FDAs programs and policies will help us protect the safety of the food supply, give the public access to safe and effective medical products, find novel ways to prevent illness and promote health, and be transparent in explaining our decision-making, says Dr. Hamburg. A strong FDA is an agency that the American public can count on.
Dr. Hamburg graduated from Harvard Medical School and completed her residency in internal medicine at what is now New YorkPresbyterian Hospital/Weill Cornell Medical Center. She conducted research on neuroscience at Rockefeller University, studied neuropharmacology at the National Institute of Mental Health, and later focused on AIDS research as assistant director of the National Institute of Allergy and Infectious Diseases.
From 2005 to 2009, Dr. Hamburg was the senior scientist at the Nuclear Threat Initiative, a foundation dedicated to reducing the threat to public safety from nuclear, chemical, and biological weapons. From 2001 to 2005, as the foundations vice president for biological programs, she advocated for broad reforms to confront the dangers of modern bioterrorism as well as the threats of naturally occurring infectious diseases such as pandemic flu.
In 1997, Dr. Hamburg accepted the position of assistant secretary for policy and evaluation in the U.S. Department of Health and Human Services. In 1994, she was elected to the membership in the Institute of Medicine, one of the youngest persons to be so honored.
From 1991 to 1997, Dr. Hamburg served as commissioner of the New York City Department of Health and Mental Hygiene. In this position, she improved services for women and children, promoted needle-exchange programs to reduce the spread of HIV, and initiated the nations first public health bioterrorism defense program. Her most celebrated achievement was curbing the spread of tuberculosis, which resurged as a major public health threat in the 1990s. As a result of Dr. Hamburgs reforms, New York Citys TB rate fell significantly over a five-year span. Her innovative approach, which included sending health care workers to patients homes to make sure they completed the drug regimen, is now a model for health departments worldwide."

DEPARTMENT OF HEALTH AND HUMAN SERVICES
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The following is the communication box containing information to assist anyone who may want to communicate with the depicted organization via telephone, facsimile or mail.
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bumping the list of those we can contact. Stopping publication of study affects the whole world and not just America. i think the CDC needs to be bombarded with messages from ones all over the world.
 

Adam

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I appreciate that we can't be sure of the contents of either of the 'embargoed' papers, but from the littlle we know or suspect, I find it difficult to believe that CDC were intending to go to press with a paper that basically stated that they found NO evidence of XMRV in either CFS patients, healthy controls, known positives and known negatives.

First off CDC cannot try to pretend that XMRV doesn't exist. That genie is well and truly out of the bottle and isn't going back in.

The question then comes down to issues of prevalence, transmission, disease association and causality.

I'm not convinced that the expected CDC findings are consistent with any anti-ME/CFS agenda. Details have already been posted of Switzer's earlier findings of no active XMRV in protate cancer cases. It has also been noted that this is CDC's retrovirology branch not the CFS team. Conclusively, finding XMRV in equal proportions of PWME/CFS and healthy controls would be more consistent with a CFS related agenda.

Infection has already been shown by the 'monkey studies' so the isssue then becomes one of prevalence.

I could easily understand that CDC might be a little embarassed that they missed a new human retrovirus that is now being found in high percentages of the general population, so it would suit their purposes to be finding low numbers. But not finding even known positives clearly makes it an issue of methodology.

I would assume that the CDC team working on this would as a matter of course keep themselves abreast of developments in the field. It has already been stated that the CDC study started relatively early, but if people on this forum are able to source information that suggests the virus is hard to find and that you need to be looking in the right place, you would expect CDC to be aware of this also.

So, being in possession of a paper which clearly states that you found no evidence of XMRV in patients and healthy controls, plus were unable to detect even known positives, and that evidence was emerging that you needed to use specific methods and look in particular places, would YOU submit the paper for publication?

If it were me, at the very least, I'd report the study findings, but with a very large caveat that the findings need to be considered in light of methodological issues which emerged after the study started. At least that would allow CDC to retain some credibility.

And then you find out that NIH and FDA teams have both independently found XMRV in even higher proportions of the general population than previously reported.


Perhaps the delay is to allow the CDC team time to add these caveats?
Nice post Marco. This line of thinking makes sense to me.

We knew all along the CDC began their work before the importance of culturing became evident. On the other hand it does make the CDC look sloppy IMO. Judy M gave them the recipe for finding XMRV - so why not use it?
 

taniaaust1

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If anyone wants to see this NIH/FDA paper published, please contact Dr. Wanda Jones, Principal Deputy Assistant Secretary for Health at the Department of Health and Human Services and tell her that you, as a patient, want the paper released and that you want a Congressional hearing on why it is being held from publication. wanda.jones@hhs.gov
done i sent the following

"Im writing in regards to the XMRV scientific studies of the FDA and NHI which have been put on publication hold. I like many others with CFS wonder why?



This isnt the way science usually works where once accepted for publishing, science enters public dormains and from which then more studies take place. It appears politics of some kind are holding up studies which have world wide implication not just for those in America. The whole world is looking on, wondering what on earth is going on in America.



Please please for all the ones with CFS about the world, we need those papers published as soon as possible for debate.



Tanya Se***

A CFS patient of 13 yrs in Australia"
 

taniaaust1

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Money and their jobs --Those older who have integrity and not fearful of loosing thier jobs will speak out.

Those in fear of their jobs, are younger and have more to loose will not stick their necks out - they have their own families to consider first. Also those who may feal humiliation in realizing that their beliefs may indeed be wrong (a psychiatrist could help them deal with that aspect)

glen
lol.. Wessley will have a new group of patients to be treating.
 

taniaaust1

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Hi

I have a draft letter to send that still needs a lot of rewriting. I thought I might try to get some feedback from the PR community first. If you want, I will make this a separate thread - if you are a moderator, feel free to move this.

I think something similar to this needs to be sent to every government health minister on the planet. A big task, but hey, send it to your local ministers and pass the message along.

We have just had a new PM appointed, I will have to check that the health minister is unchanged and haven't done this yet.

Bye
Alex

The Hon Nicola Roxon MP, Minister for Health and Ageing,

I have sent you two previous emails about the risks from the transmissible retrovirus XMRV. I have requested that you commence planning to deal with this potential pandemic, but that acting on this planning had to wait on the science. The science debate is largely over, the time to act is now. Even if pathogenicity is later disproved, this is not something we can delay acting on.

This email is being sent to every health and shadow health minister in Australia. It is also being sent to selected media outlets and CFS patient information forums. A full list is included at the end, as is a copy of each of my previous two emails. I intend to send a similar updated email after every major new scientific publication. There are at least twenty two studies awaiting publication that I am aware of. Many more studies have commenced.

This action is prompted by the USA DHHS delaying or stopping publication of two important scientific papers on this topic that were about to be published and have passed peer review:

http://news.sciencemag.org/scienceinsider/2010/06/conflicting-papers-on-hold-as-xm.html

This science insider article is a preview of the upcoming longer article in Science.

Just to recap the science, pathogenicity of this virus is not proven, but transmissibility is all but proven, as is prevalence. The original science has now been confirmed by two US studies from the FDA and NIH, both of which await publication. The prevalence of XMRV in the healthy population appears to be between 3 to 7%. This does not include prevalence of the sick, disabled or dying. This virus is now linked to prostate cancer, autism, atypical multiple sclerosis, fibromyalgia, chronic fatigue syndrome, myalgic encephalomyelitis, and Gulf War syndrome, and suspected of being linked to breast cancer. Several of these illnesses are growing in incidence, as you are aware. The virus does not contain an oncogene, but it is a retrovirus with a hormone response element. It inserts into the DNA and is hypothesised to confer hormone sensitivity to nearby genes. This includes oncogenes, which can then be switched on by stress or sex hormones (male and female). The neuroimmune diseases it is linked to are all very similar, with similar biochemistry and symptoms. The virus appears to require an immune trigger before causing disease, and is suspected of being a risk with vaccination in those with the virus - but vaccination will only cause a premature trigger as these people are already at high risk. The lifespan of CFS patients might be twenty five years less than the rest of the population.

There might be two million Australians already infected by XMRV, many of whom are disabled, all of whom are at risk. Even a conservative estimate would now have to be 660,000 healthy Australians infected with XMRV.

I was very pleased that the Australian Red Cross Blood Bank has indefinitely deferred the donation of blood from patients with CFS. However, this is only a small subset of people with the virus, many of whom are still healthy. Like with HIV, XMRV can lie dormant for years or decades before causing illness or death. Those infected but not yet sick may be capable of spreading the virus, and there is no barrier to their donating blood.

Three antiretroviral drugs are known to treat XMRV in the lab. Off-label treatment with these drugs is anecdotally reported to be achieving good results after three months of treatment.

Several feature documentaries are currently being made that deal with these issues.

The time for action is here. Please let me know as soon as possible what your preliminary action is likely to be, and keep me updated with further information as you make it public.

As this is an election year, this might well be an election issue.

What needs to be done:

1. Immediate and ongoing government consultation with world experts needs to commence.

2. Australian scientific studies on this virus need to commence, so funding needs to be made available as a national priority.

3. Preliminary steps need to be undertaken to commence antiretroviral trials in Australia, prior to coverage under the PBS. Coverage should include both XMRV testing and treatment protocols. This is particularly important to those already disabled by this virus as most will struggle to afford testing or treatment.

4. Blood banks need to be screened for XMRV contamination prior to the development of XMRV neutralizing methodologies. Stored blood samples might be tested so we have an idea of who this virus has already been transmitted to though the blood banks.

5. Free or subsidized testing needs to be offered to the entire public to allow us to identify who has the virus so that public health education can commence.

6. A public health education campaign needs to commence to prevent undue panic. This virus is probably treatable, but not curable.

6. Work needs to commence on a vaccine against this virus. It is very important to get the science right as vaccination with an ineffective vaccine can trigger the virus. This virus is simple with a slow mutation rate, so developing a vaccine should be very easy.

The you for your urgent attention to this matter.

Bye
Alex Young
B.Sc. (biochemistry), B.Inf.

(I have omitted inclusions for brevity.)
Hi Alex, i think it has too much in it which thou we assume is fact.. at this point cant be said to be fact at all eg XMRV can lie dormant for years or decades before causing illness or death.
 

pollycbr125

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NEWS EMBARGO LIFTED ON PNAS ARTICLES SHOULD BE PUBLISHED AT 3PM EASTERN TIME .http://www.pnas.org/site/misc/journalist.shtml

should be around 8pm uk time

though that does not mean it will be published today .Also could it relate to other papers did they have an embargo on something else . i got all excited for a minute till someone pointed out it might not be our paper . sorry if ive jumped the gun we will have to wait and see
 

taniaaust1

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CDC paper finally released

FULL TEXT

Absence of evidence of Xenotropic Murine Leukemia Virus-related virus infection in persons with Chronic Fatigue Syndrome and healthy controls in the United States
William M Switzer , Hongwei Jia , Oliver Hohn , HaoQiang Zheng , Shaohua Tang , Anupama Shankar , Norbert Bannert , Graham Simmons , R Michael Hendry , Virginia R Falkenberg , William C Reeves and Walid Heneine

Retrovirology 2010, 7:57doi:10.1186/1742-4690-7-57

Published: 1 July 2010
Abstract (provisional)

Background
XMRV, a xenotropic murine leukemia virus (MuLV)-related virus, was recently identified by PCR testing in 67% of persons with chronic fatigue syndrome (CFS) and in 3.7% of healthy persons from the United States. To investigate the association of XMRV with CFS we tested blood specimens from 51 persons with CFS and 56 healthy persons from the US for evidence of XMRV infection by using serologic and molecular assays. Blinded PCR and serologic testing were performed at the US Centers for Disease Control and Prevention (CDC) and at two additional laboratories.

Results
Archived blood specimens were tested from persons with CFS defined by the revised 1994 CDC case definition and matched healthy controls from Wichita, Kansas and metropolitan, urban, and rural Georgia populations. Serologic testing at CDC utilized a Western blot (WB) assay that showed excellent sensitivity to MuLV and XMRV polyclonal or monoclonal antibodies, and no reactivity on sera from 121 US blood donors or 26 HTLV-and HIV-infected sera. Plasma from 51 CFS cases and plasma from 53 controls were all WB negative. Additional blinded screening of the 51 cases and 53 controls at the Robert Koch Institute using an ELISA employing recombinant Gag and Env XMRV proteins identified weak seroreactivity in one CFS case and a healthy control, which was not confirmed by immunofluorescence. PCR testing at CDC employed a gag and a pol nested PCR assay with a detection threshold of 10 copies in 1 ug of human DNA. DNA specimens from 50 CFS patients and 56 controls and 41 US blood donors were all PCR-negative. Blinded testing by a second nested gag PCR assay at the Blood Systems Research Institute was also negative for DNA specimens from the 50 CFS cases and 56 controls.

Conclusions
We did not find any evidence of infection with XMRV in our U.S. study population of CFS patients or healthy controls by using multiple molecular and serologic assays. These data do not support an association of XMRV with CFS.
Interesting how the CDC manages to get its negative paper out before the embargo time is up (if it is at 3.00pm Eastern time.... while the postive studies seem to have to wait. **wondering if it is coincidence.. or if someone just wanted to make sure that paper hit first!**
 
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I just asked a friend of mine who is a big proponent of breast feeding, she organizes clubs about this (Laleche) goes to world-wide conferences etc. I asked her what she new about XMRV and how it affected breast milk. I explained this would concern ME/CFIDS Moms. I had the fastest response back ever. She knows nothing about this, but would do some digging about it. Inside I laughed because I am sure her digging would get no more answers then we are getting, but at least it is another place for buzz and since they deal with medical personal all the time, just another avenue to go through.

I am hoping we get answers soon, but I feel hopeful that they are just trying to put in place education etc. In the meantime it is important to keep vocal about this.
 
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Is there a petition that those from around the world can sign? I just went to the petion site and only those from the US can sign.
 
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What is the CAA doing to speak out on our community's behalf, to raise these articulate and cogent concerns and wave them in front of the media, to take the lead as the association representing us and speak out against what is unfolding? I'm thinking time is not on our side. We need to be heard, collectively, through our "voice", now, in strong and reputable rebuttal.
 

shannah

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"Is there a petition that those from around the world can sign? I just went to the petion site and only those from the US can sign."

Cruzgirl,

It seems to accept signatures from some countries but not others. I see someone from Portugal and Poland have signed. I had great difficulty from Canada and it would only work by entering a state and zip code.
 

Marco

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So, being in possession of a paper which clearly states that you found no evidence of XMRV in patients and healthy controls, plus were unable to detect even known positives, and that evidence was emerging that you needed to use specific methods and look in particular places, would YOU submit the paper for publication?

If it were me, at the very least, I'd report the study findings, but with a very large caveat that the findings need to be considered in light of methodological issues which emerged after the study started. At least that would allow CDC to retain some credibility.

And then you find out that NIH and FDA teams have both independently found XMRV in even higher proportions of the general population than previously reported.


Perhaps the delay is to allow the CDC team time to add these caveats?
Hell - what do I know?

This is beyond farcical. These people are just playing games.
 

Mark

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Could be something...

http://projectreporter.nih.gov/project_info_details.cfm?aid=7977530&icde=4356584

Project Start Date: 15-Jun-2010
Project End Date: 31-May 2012


THE RELATIONSHIP OF XMRV TO FUNCTIONAL STATUS AND CO-INFECTIONS IN CHRONIC FATIGU HANSON, MAUREEN REBECCA CORNELL UNIVERSITY ITHACA 2010 NIAID NIAID
$269,496

THE ROLE OF XMRV, A NEWLY DISCOVERED HUMAN RETROVIRUS, IN CANCER PATHOGENESIS SINGH, ILA R UNIVERSITY OF UTAH 2010 NCI NCI
$312,288
http://projectreporter.nih.gov/repo...=0&icde=4356584&CFID=8861466&CFTOKEN=14652864
 

kurt

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I worked in government research labs, too, and family still does. Papers were vetted in-house before they were sent for review and publication. The idea was that if the work was not considered suitable for publication it was held before it was sent to publishers. This is as much a matter of courtesy as a desire to withold information. Putting the publication and the peer-reviewers through the work involved in preparing the paper for publication and then pulling the paper afterwards is not respectful of our professional colleagues.

I'm not denying your experience. You probably worked in a bigger lab than I did, and in a different technical area, so policies could be different depending on the circumstances. I do not doubt that your agency worked as you said. Nevertheless, I still find it surprising that they would wait until after the paper has been in the hands of peer-reviewers and publisher's staff before they would review it in-house for issues that might reflect on the agency. But then, lots of things surprise me, so this is nothing new. :Retro smile:

So, this is not how science works in all government labs, certainly none that I worked with routinely, but I bow to your experience in a government lab and acknowledge that it may work that way in some, or perhaps even many, government research labs. Sad.

Based on your evident knowledge of medical/public health research, I accept that your assessment of what is going on with HHS/NIH/CDC is correct. I didn't mean to negate your experience. I was simply astounded that your lab experience is so different from mine. :Retro smile:
Hi Sickofcfs, I agree with you, usually the in-house review comes before sending to outside pub, but there still can be a final approval required before final release. Anyway, I just re-read my post and I was not very clear about the sequence, so I corrected that, I was writing too fast perhaps and that was a lot of years ago I was at the govt lab. Anyway, these are simply reviews that have to happen at some time, probably the order can change. Each lab has their own policies. Obviously the point is moot now wrt the CDC study.

Dr Yes & Hope, I made a mistake in my post, in a literal reading, and have corrected that now. The order Sickofcfs states is usually correct, I was trying to point out that there are many layers of review. The sequence of events can vary and the 'big brother' reviewers at these agencies can step in at any time and stop the presses. That is what I was trying to communicate. What happened was not that unusual, it is the problem finding XMRV that is unusual, particularly in the 'PCR age' where we think we can find anything.

Kurt,
You know very well that obstructing science on ME is practically their full-time job!! Statements like this are very misleading for people who don't know the history of these agencies. Please do not post untruths like this!
Nobody that I know about involved in XMRV research is trying to obstruct science on ME. I don't disagree with you that there may be people who take that as their job, particularly in the UK. But in this case, with the XMRV research I do not see this happening. What REALLY happened here is that the CDC ran some very good XMRV tests and found nothing. I don't think they understand why any better than anyone else right now.


If they couldn't find it in 22 samples from "independently confirmed positive controls from different labs" - wouldn't that mean that their particular methodology isn't able to detect XMRV at all?
You'd think that even if they weren't able to find it in their cohort of patients, if their test worked they would be able to find it in samples already known to be positive... I wonder what those 22 samples are and where they are from.
This is the controversy, we can not presume yet what the reality is here, who is really right. The CDC could find positives in their OWN positive controls. So they would disagree that the other positives are really positive and might think the other labs have contamination, etc. This all has to be worked out.