The findings by the NIH and FDA that XMRV is associated with chronic fatigue syndrome has been accepted for publication by the Proceedings of the National Academy of Sciences (PNAS). Release of the article has been blocked by PNAS due to work carried out by the US Centers for Disease Control and Prevention (CDC). That study, which was submitted to Retrovirology, failed to find a link between XMRV and CFS. Its publication has also been placed on hold. According to ScienceInsider:
The contradiction has caused “nervousness” both at PNAS and among senior officials within the Department of Health and Human Services, of which all three agencies are part, says one scientist with inside knowledge.
It is senseless to block publication because the two papers reach different conclusions. If both manuscripts were subjected to proper peer-review, and were deemed acceptable by the referees, then they should be published. The journal editorial offices must respect the opinions of the reviewers. By overriding their decisions, they have compromised the entire peer reviewer process.
Blocking publication also sends the wrong message to CFS patients, to the public, and scientists. Not only does this action raise suspicions about their motives – are they trying to publish only the result they believe is correct? – but it ignores the very important fact that science is self correcting. Scientists are humans, and they make mistakes. But eventually the right answer will come to the surface. And that is why PNAS and Retrovirology should respect peer review, publish the XMRV papers, and let science correct itself.
Update: As noted in the comments section, the results of the CDC study have been published in Retrovirology.
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Sign the petition to release the studies!
http://healthcare.change.org/petitions/view/xmr…
I simply do not see how this can be construed as being done in the best interest of CFS patients. We need the larger scientific community to have access to all of the methods and results from both studies as soon as possible.
Were the articles held out of fear of creating panic in the general population? In the long run has ignorance ever helped anyone?
The HHS is risking it's own credibility as well as that of PNAS, the CDC, the FDA/NIH in trying to 'manage' this. Since when was science about reaching consensus before releasing the results of a publication?
This is the triumph of petty agency politics between the CDC on one side and the NIH/FDA on the other, with people suffering from ME/CFS the losers.
It is a sad day when petty politics triumphs over science.
indeed…
I'm afraid that it wouldn't be the first time with ME/CFS.
This petition contains the words: “Tell the DHHS to allow the NIH and FDA to publish their papers.”
The DHHS does not have the right to prevent publication of scientific papers, and thus we should not be asking them to “allow” publication. We should be requiring that the DHHS rescind their demand to the journal(s) to not publish, and that the DHHS state that they have no authority to prevent publication of scientific papers.
As it stands, I can't sign this petition for this reason.
I have been a patient since 1982 and my budding career as a scientist was destroyed by this illness. I withdrew from a Ph.D. program in 1984.
Of course, CDC has absolutely zero credibility in the field of ME/CFIDS. Both CDC and NIH have done everything within their power to obstruct science in ME/CFIDS/AIDS-X for 25 years. The longer they can delay real science the longer they (Reeves, Fauci, etc.) can hold on to their jobs and stay out of prison.
Don't let the CDC continue to allow this Retrovirus to spread. They must not hide if from us- as has been in the past. Look what happened with syhyliss –look what happened to the Dr Freitas retrovirus “poof” and how HIV was allowed to spread
if your going to get bent out of shape over the wording at this stage in the game… then you need a reality check. do you want to move forward or not? if you don't like the wording in the petition, then at least figure out the email addresses of the Senators and Reps in your area as well as the contact info for the CDC, NIH, FDA, and the President… let them know it in your own words… but please do something, and don't flip out on the people that are actually trying to do something. I don't feel good either.
Thanks a lot for stating your view, sir; it really means something to us patients on a day when /Science/ wrote about this decision without giving notice to any sort of critical perspective. In another context, this HHS action probably wouldn't be a big deal. But it's just wrong in this context — that of CDC having told the people in the Tahoe epidemic they were hysterics 30 years ago, CDC's director having publicly stated that he expected to falsify Mikovits, CDC having a long record of strongly tending to consider this disease psychogenic, and CDC even trying in recent years to (on one perspective) “dilute” the disease by means of a new syndrome definition corresponding to a 6-10x greater prevalence and much lower median debility.
HHS, in meddling with this for whatever reason, is leaning hard on trust that doesn't exist. It's a shame that they haven't even pledged to eventually release the papers as they existed prior to being sequestered and potentially reshaped under political influence.
CDC paper is now published!!!!! HELP ALL OF US PLEASE!!!
THE MOTIVE IS QUITE CLEAR.
THE CDC HAS DENIED THERE WAS EVER A RETROVIRUS AND DESTROYED DR DEFRIETAS'S CAREER WHEN SHE FOUND IT IN CFS 20 YEARS AGO.
THE CDC'S LATEST XMRV STUDY PUBLISHED IN RETROVIROLOGY JULY 1 2010 DID NOT FIND XMRV IN THE CFS GROUP NOR THE CONTROLS. FINDING XMRV IN CFS HAS BEEN CONTROVERSIAL, BUT FINDING XMRV IN CONTROLS IS NOT AFTER AT LEAST 4-5 STUDIES HAVE PROVED IT.
CDC'S NEGATIVE XMRV PAPER GOES UP AGAINST THE POSITIVE XMRV STUDIES PUBLISHED IN LAST OCTOBER'S SCIENCE BY THE WPI, NCI, CLEVELAND CLINIC AND UP AGAINST THE SOON TO BE PUBLISHED POSITIVE XMRV STUDY IN THE PNAS BY NIH AND FDA.
THERE ARE ABOUT 12 OTHER POSITIVE XMRV STUDIES READY FOR PUBLISH THIS SUMMER.
WHAT IS THE MOTIVE OF THE CDC? ARE THEY COMPLETELY INCOMPETENT OR IS THERE A CDC-CFS CONSPIRACY THAT HAS GONE BACK 20 YEARS WITH DR DEFREITAS?
Vince:
thank you. in order for any science to work efficiently, the publication process should be transparent and without political maneuvering behind the scenes, but seemingly few scientists are willing to step up and lend their voice when something like this happens. thank you. I am an avid listener of your podcast.
By the way — do you have one in your podcast to recommend to listen to that deals with viruses and the interaction between glia cells and viruses????
I work as postdoc on XMRV in a laboratory next to Dr. Racaniello and appeared on a few of his podcasts.
This is sad news for research scientists in general. If the manuscript was reviewed by peers in the field and accepted for publication, it should be published – end of story. The point is to publish opposing views. That way the research community works that much harder in getting the story right.
This amounts to censorship and suggests there is no point in the peer review system. I'm really against this and won't submit my upcoming paper in either PNAS or Retrovirology.
Jason
In the united kingdom, you are put in psychiatric hospitals for months if you have CFS, right now there are people with CFS in these hospitals. We have got to sort this out for the sake of these people and for the sake of those that are so sick, they cant walk, talk, eat – some are young men and women, teenagers, people in there 20s, we have got to let the science help these people.
I will never submit a paper in PNAS or Retrovirology again! (disgraceful)
2 CONFLICTING STATEMENTS!
QUOTE WSJ 30th June:
The paper was accepted for publication in the journal Proceedings of the National Academy of Sciences of the United States of America but is on hold, according to Ashley Truxon, media coordinator for the journal.
QUOTE DR ALTER 1st July:
“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
XMRV APPEAL FOR RESEARCH:
http://www.youtube.com/watch?v=iWvWs1rGhrE&feat…
Jason, do your best work and find the truth for the millions of us horribly afflicted and dying of ME/CFIDS. We are suffering 24/7 and this is no way for anyone to live. Some have given up and let go this endless torturous disease, but we must persist and exist in the hopes that a cause and a cure to this dreaded disease is shortly found. No human should have to live this way. Let your hard work and high integrity steer you to publishing the truth to the world! What you do in the laboratory, jason, is God's hand at work. Please remember ME.
As everyone expected the CDC did not find XMRV. As always they used their flawed CFS group collected from Georgia. As reported elsewhere, when the study details for this group was looked at it was found that the average number of hours worked for people in this group was over 40. This hardly makes them CFS patients but rather fatigued controls. Still interesting that they were unable to find any XMRV at all.
Why is it that researchers keep looking for it in blood when the animal models as presented at CROI found that there were no detectible amounts of XMRV in their plasma when they were in fact infected.
i keep looking for an actual link to this quote… and i can't find any. I think its just hearsay at this point. I am going with the WSJ until there is a credible source for this statement.
Ive double checked… and it doesn't appear on the NIH pages anywhere… its nothing but a bunch of dead links on facebook…. so why are people making stuff like this up?
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This paper again highlights the problem with CFS research. There is no agreed upon marker for CFS. The group the CDC looked in for XMRV is flawed and doesn't follow the commonly accepted criteria. It is generally called the “Reeves” criteria as it was developed by him. In effect they are looking for XMRV in tired people not those with CFS.
I really really wish the researchers would work together and come up with some sort of commonly agreed upon criteria based upon measurable physical characteristics and stick to it. If one group is looking at frogs and another at lizards you are going to get different results.
Again, there is a bunch of truly sick people who are not being helped by this.
It again makes me wonder why people are looking for XMRV in blood when it was shown in the animal models as being hard to find. Why not look where the animal models shows it was hanging out. I realize the first paper said they found it there but if more information comes out showing that it is hard to find there why keep looking in the most difficult place to find the virus. It seems insane.
If I was managing this I would:
1) Establish a common criteria based on something that is measureable and can be agreed upon. There are several recent papers that suggest various bio markers.
2) Standardize the test. As pointed out by this paper, this is difficult since at the moment there is an “absence of bona fide positive and negative control specimens
from infected and uninfected humans to determine the analytical sensitivity and specificity of the detection assays”. Couldn't they have used blood from prostate cancer patients or those found from throat swabs to see if they could find it there? Also couldn't they have at least used samples from the animal controls from the CROI study? If you don't know if your test can actually find XRMV is people who has it isn't your test kind of a waste of time?
3) Conduct real research
“Dr. Alter and many others studying XMRV and related blood safety issues are attending the 31st meeting of the International Blood Society Transfusion meeting in Berlin (June 26-July1), so the NIH Office of Comm. and Public Liaison provided his statement. We'll pass along more information about the status of the paper as soon as it is available.”
http://www.facebook.com/CFIDSAssn
This from the CFIDS Association web-site: (http://www.cfids.org/xmrv/070110study.asp)
“So the explanation for not finding XMRV in these samples is simple – this was a study designed to not detect XMRV using a hodge-podge sample set.”
And
“Detecting XMRV is hard. Replication of the Science paper will be hard because of the exacting methods required and because of the heterogeneity and complexity of CFS. Regardless of the outcome of any single study, it is critical that a valid replication study be designed and implemented by multiple laboratories, using standard and optimized techniques and testing split samples collected appropriately from adequate numbers of well-characterized cases and controls. (my cr for emphasis)
Studies such as this one from Switzer, et al., continue to absorb time, divert precious resources and fuel controversy instead of consensus.”
Dr Vernon,
Thank You!
More info re: Alter comment-
http://www.facebook.com/notes/the-cfids-associa…
I am absolutely livid after reading the CDC paper, especially the following:
“The physical findings in persons meeting the Canadian definition may signal the presence of a neurologic condition
considered exclusionary for CFS and thus the XMRV positive persons in the Lombardi et
al. study may represent a clinical subset of patients.”
They know exactly what they're doing to ME patients; they have all along. They know CCC is right and they are trying to reframe “CFS” as tired people by using Reeves definition exclusively and saying that neurologic disease and signs are inconsistent with “CFS”. And they approve of the Oxford definition used in the dutch study; repeating Dr. Vernon's nonsense that the Dutch and UK studies were well characterized and WPI was not!! They are explicitly insisting Oxford is valid and Canadian Consensus Criteria are invalid!!
They are only looking at people with the spurious Reeves definition “CFS”. Seems like they are trying to hide this fact from casual readers with opaque drawn out method explanations.
They mention a connection with HTLV II has not panned out. Obviously they are talking about DeFreitas RV and repeating their propaganda that DeFreitas RV is nothing more than HTLV II !!
Let's not forget that Heneine, was perhaps the most responsible for screwing up the CDC DeFreitas 'replication attempt' and destroying her reputation.
This study is totally incredible on its face for the above reasons and the fact that if Reeves and Heneine published findings different from what they did they would be acting directly against their 'penal interest'. Ie publishing these nonsense negative findings, supporting the patently invalid Dutch study and suppressing the NIH & FDA study keeps Reeves, Heneine and co-cospirators out of prison longer than otherwise!Publishing the truth would land them in prison.
Conversely, the fact that NIH (and to a lesser extent FDA) would be acting against their 'penal interests' by publishing positive data showing a connection between ME/AIDS-X and XMRV makes the NIH/FDA study even more credible than it otherwise would be! That is, NIH is coming out with a positive study; a positive study could well result in NIH's Anthony Fauci and Eleanor Hanna losing their jobs. Thus, the NIH study is credible because it's institutional author (NIH) has much to loose and nothing to gain from it.
This is the DeFreitas RV scandal all over again! We can't let this happen! Make your voice heard!
YES … i want something more than just a facebook splash page… why does this NOT appear on the NIH ANYwhere?
I STILL doubt the credibility of this statement. WSJ had it RIGHT.
Dr Racaniello, I appreciate you covering the XMRV issues in ME/CFS. Your voice is important as a virologist and professor, and somehow representing the scientific community without being directly implicated. The ME/CFS community is looking up to you, more than you think.
I hope that politics of health care and research stays away from the truth of the science.
Actually the World Health Organization has classified CFS, along with myalgic encephalomyelitis and post viral fatigue syndrome exclusively under organic brain disorders (G93.3) in the ICD-10. Is the CDC study referring to yet another neurological disease other than CFS? The 2005 study from which the samples were gathered did not test for any viruses in patient volunteers despite CFS being in the chronic viral diseases branch and excluded patients with neurological signs common to CFS such as a positive Romberg.
As for classification, in the United States the CDC controls which ICD version is used and can modify it providing they have sufficient scientific evidence. Right now the CDC is using the ICD-9 which did not have CFS in it (the name did not exist in the 70s) although myalgic encephalomyelitis was listed. ICD listings are used both to determine mortality and by insurance companies.
A search of the CDC site shows that myalgic encephalomyelitis is currently deleted from the ICD-10 CM and post viral fatigue (G93.3) is separated out from CFS. Based on the video from the HHS CFS Advisory Committee recommendations from the May 2010 meeting they recommended that CFS not be placed by the CDC ICD-10 CM committee under psychiatric disorders.
http://i147.photobucket.com/albums/r318/crafter…
For the Love of God will any other science agency besides WPI stand up for us and the truth!
I am not positive, but I think the petition allows you to make changes to it before you hit send (in the text box). So you can always make the changes you wish.
Thank you, as always, for your continued excellent coverage of XMRV. It is my hope the FDA and NIH study will soon be published as well, and will blow the ridiculous CDC study out of the water.
The CDC study looks ridiculous. they can't find XMRV not only in CFS groups, but in controls and positive XMRV samples provided to them. They further choose their CFS groups from an outdated Holmes criteria of CFS that includes fatigue from depression, obesity, and metabolic strain(per reeves) instead of the widely accepted and very specific ME/CFS definition in the canadian criteria and fukuda criteria of ME/CFIDS/CFS.
Even after the firing of Reeves, why does the CDC continue to be the idiot of CFS/ME research. What have they accomplished in 20 years except making PWC feel horribly worse with GET and CBT. For god sakes, we have in immune disease caused by a retrovirus which is not going away with graded exercise or to talk our way out with a psychiatrist.
Get Real!
For God's sake someone open your eyes and do the right thing for millions of sufferers please!
“CDC's director having publicly stated that he expected to falsify Mikovits”
The CDC director is Thomas Friedan. Reeves was the head of CFS for CDC research until he stepped down. It was Reeves who famously said he expected not to find XMRV in CFS in the NYTimes. And now his name is on the Retrovirology.
And people like McClure are disgusted that patients are so angry…
I am a severely ill, bedridden CFS patient.
The only thing stopping me from donating blood is the fact that I would need a wheelchair and someone to drive me to the Red Cross. I am legally able to donate. I was a frequent donor the two years prior to becoming ill. I stopped donating at that point and haven't since.
The worst thing I could imagine is someone getting a transfusion and ending up with this incarcerating disease. I am a mummy in my own body. I have had influenza sans cough for fifteen years.
This BS needs to end, NOW. The CDC should have waited for a verified test before testing patients. They should have used something other than their crappy dial-up cohort. People who are sick like me don't get into studies because we can't leave the house. If this is disease causing and being passed to transfusion patients right now while scientists have a pissing contest, that is the most unconscionable thing I can imagine outside of the years that HIV was passed to transfusion patients.
The petition was a brilliant idea and really well written. Judson took the bull by the horns and did what others did not do. I appreciate the efforts that went into that petition and the numbers of people who have signed also recognize the amount of time, energy and effort in that petition. Well done and thank you Judson for your work. Wish others would stop complaining to eachother and start complaining and demanding to our government to put science first and leave behind-covering elsewhere for once.
Prison for Reeves and all others involved in almost 30 years of this CFIDS cover-up is in order. So is a complete investigation of the CDC and not just the CDC/CFS program. Though at this point I believe it is critical that the CFS program be investigated. What are they hiding and who are they hiding it for?
Three decades of destroying the lives of humans deserves prison for the rest of their lives.
Sign the petition and then email the DHHS ((Kathleen.Sebelius@hhs.gov)) and DEMAND that they release the FDA and NIH studies as is and without government damaging science.
We are all very sick. I too withdrew from my doctorate after getting two grad degrees and killing myself in a demanding career. That would be the same type of story that all other CFIDS people can tell about their destroyed lives.
even beyond these statements…. we still must ask the additional question… why more tests? why more scrutiny? why is THIS paper and not the CDC paper, being put through weeks of extra testing???
the paper is obviously being subjected to procedures beyond the bounds of the scientific process
Then open your mouth to the right people. See if you can help Dr. R in any way.
We are terribly sick and disabled people who are bedbound and housebound. We die about 25 years before our time at average age of 55. Is that fair to keep us in this state because the CDC has been playing games for 30 years and others are assisting them?
“…it ignores the very important fact that science is self correcting.”
Yes! The HHS officials who made this decision should allow the scientific process to work. Let the scientific community judge the papers.
Yes, thank you Dr Racaniello. What Kati said is what I was looking for the words to say.
“The DHHS does not have the right to prevent publication of scientific papers”
Whether or not they have the 'right' to prevent publication, they did it. Apparently, even if they don't have the right, they have the power. So at this point I think that telling to allow publication makes sense.
However, if you feel strongly about the wording of the petition, may I suggest that instead you contact HHS Secretary Kathleen Sebelius and Assistant Secretary for Health Dr Howard Koh directly? Or write to you elected federal officials? The point is let your voice be heard by the people in power.
Please help us, we want to get well, we have had enough of being poorly. Please government, scientists, researchers, doctors – Let 2010 be the year for answers.
We have struggled on for decades, we feel so sick, weak and very ill.
There is only one chance at life – Please give us our lives back.
We have been ill for decades and need research to move forward and be translated into standardized best-practise bio-medical dignostic and treatment methods ASAP! Tragically, ME/CFS patients world-wide are caught up in an ideological battle instigated by moral behavioralists like Reeve and neo-Freudians typifid by Wessley against biological scientists. Is history repeating itself I wonder? I see the CDC and U.K institutions invested in recycling negative and positive eugenics popular in the first half of the twentieth century for mental disorders to manage ME/CFS in the 21st century. In eugenics in the 1930's for people with serious psychiatric illness the idea was if you could just corrrect the (moral) behaviour of ill patients and/or educate them to understand they have a thought disorder (false conciousness) then they will be cured. How this has been reserrected for ME/CFS is beyond me because moral and psychoanalytic appraoches in psychiatry are outdated models driven by social darwinism which have been proven unhelpful, even harmful. Not to mention they are associted with old politcal notions of degeneracy and criminality among the impoversihed in society.
The CDC paper is part of a historially abusive paradigm that is ignoring the World Health Organization definition of ME as a neurological disorder. (The manouver by the CDC to redefine XMRV positve people as suffering from a seperate organic disorder is a part of this abuse.) Socail Darwinian explanitory models for disease have no place in modern science and history and need to challenged and abandoned before we see suffering like in we have for people with neuropsychiatric disorders throughout history.
Marie
I would also like to thank you for this post, Dr Racaniello. As an ME/CFS patient for 20 years, I urge all concerned researchers to resist this blatant political interference in the scientific process.