Chronology of the NIH/FDA and CDC paper scandal

Updated July 10th, 2010

This is a play by play of every conflicting statement from sources throughout this scandal! 

June 22, 2010- Ortho releases a press release claiming that the FDA and NIH have independently confirmed in a soon to be published paper the WPI findings linking XMRV (a new retrovirus) to ME/CFS. 

“ORTHO contacted Dr. Harvey Alter today for a reaction. He did not want to comment, but confirmed that a paper is soon to be published.”

June 22, 2010- Hillary Johnson, author of Osler’s Web posts on her blog
“I received a call today from an investigator at a major American university who is involved with XMRV research. He is the second reseacher-scientist to have advised me in as many weeks that a major research paper is about to be published in which the conclusions reached by the authors of the Science paper of October 9, 2009--which linked the gammaretrovirus XMRV to chronic fatigue syndrome and proved it was infectious--have been replicated. In addition, the new data may be even stronger. In other words, the positivity rate among chronic fatigue syndrome patients may be significantly higher. In addition, silent or latent infections in the general population may be, in this new data, as much as twice as high as originally reported in Science. 

June 30, 2010- Wall Street Journal reports that the NIH/FDA paper are being held back from publication because the CDC was unable to find XMRV in their study

“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. She had no further comment.”

“Kuan-Teh Jeang, editor-in-chief of Retrovirology, said the Switzer paper went through peer review and was accepted for publication when he got a call from the authors earlier this month. They asked that the Retrovirology paper be held.”

"My understanding was HHS [Department of Health and Human Services] wanted to get it straightened out. Both reports are from different branches of the government," Dr. Jeang said. “

June 30, 2010 Science magazine confirms that the papers are on hold 

“Science has learned that a paper describing the new findings, already accepted by the Proceedings of the National Academy of Sciences (PNAS), has been put on hold because it directly contradicts another as-yet-unpublished study by a third government agency, the U.S. Centers for Disease Control and Prevention (CDC). That paper, a retrovirus scientist says, has been submitted to Retrovirology and is also on hold; it fails to find a link between the xenotropic murine leukemia virus-related virus (XMRV) and CFS. 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.”

June 30, 2010 Dr. Vincent Racaniello writes in his blog that the papers must not be blocked

“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.”

July 1st, 2010  early morning CDC paper published in Retrovirology  The study finds no XMRV, however, it found its “CFS patients” through phone surveys rather through those diagnosed by a doctor. Unlike the WPI study, the Canadian Criteria for ME/CFS was not used to select patients.

 July 1st, 2010 The CAA posts a message on their facebook fan page that conflicts with all other existing reports. The information reportedly came from the NIH,

“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

The question remains why the NIH allowed the CAA to speak for it, when the NIH could have released Dr. Alter’s statement to the media through a press release to the media. This July 1st statement conflicts with all previous statements that the NIH/FDA paper had been accepted before the involvement of the DHHS and CDC.

July 1st, 2010 Wall street journal publishes article about CDC paper

“John T. Burklow, a spokesman for NIH, says the FDA-NIH paper has been accepted for publication but that the authors decided to pull it back to conduct additional experiments. Publication will depend on how long it takes to fully address questions. “It’s a matter of getting it right,” he says”

July 1st, 2010 Dr. Suzanne Vernon of CAA publishes critique of CDC study

"There is little indication that these three cohorts are comparable in regard to CFS definition, as each cohort was selected using different definition. The authors strenuously object to application of the Canadian case definition in other studies, stating that, “physical findings in persons meeting the Canadian definition may signal the presence of a neurological condition considered exclusionary for CFS.” Yet the physical findings listed are those commonly experienced by CFS patients, and one (tender lymphadenopathy) is a case-defining symptom of the 1994 criteria."

July 2nd, 2010 CDC calls it’s holding back of paper a ‘strategic pause” published in Nature news

“Monroe called the delay a "strategic pause", initiated after CDC officials learned of a contradictory study by the NIH and FDA team, reported at a meeting by NIH researcher Harvey Alter. Although a PNAS spokeswoman reportedly told The Wall Street Journal that the study had been accepted for publication, press officers at PNAS refused to comment on the matter today. 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.”

July 2nd, 2010 Press release from the WPI regarding the CDC paper



July 2nd, 2010 Science Magazine updates its story on the publication of the CDC paper


“UPDATE 2 July: The authors of the PNAS paper have decided it needs more work. Corresponding author Harvey Alter of the NIH Clinical Center, who is in Berlin this week, issued this statement on 30 June: "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." NIH spokesperson John Burklow explained to Insider that the paper had been accepted, but Alter and his co-authors decided to "pull it back" and revise it in response to questions raised by reviewers.”


July 3rd - Q and Spin with the CDC by Mindy Kitei for CFS Central
"CFS Central:
“Why did the CDC request the FDA/NIH study be put on hold pending more research?”
Dr. Steve Monroe, director of CDC’s division of High Consequence Pathogens and Pathology:
When CDC, FDA, and NIH learned that separate studies had been conducted with differing results, a collective decision was made to try and account for these differences.” "

July 6th. Mindy Kitei, freelance Science Reporter for CFS Central reports "CFS Central has learned that it was the CDC that made the initial request to pull the FDA/NIH XMRV paper after the Proceedings of the National Academy of Sciences (PNAS) accepted it. Sources have told CFS Central that higher-ups in the Department of Health and Human Services (HHS) made the ultimate decision to hold up ... See Morethe study. In addition, insiders said that HHS can keep any government study from being published—no matter how solid—and that it is anyone’s guess whether the FDA/NIH paper will eventually be published."  

July 6th Hillary Johnson, author of Osler's Web gives us a clearer picture of the events surrounded the FDA/NIH Paper   

It is interesting to note in her report that the Alter paper after undergoing extensive peer review was in galley-proof (near final version) .  

She writes, "Three months prior (probably in March) the authors were invited by scientists at the Centers for Disease Control to brief the CDC about their study. Although the CDC scientists asked these authors for all details of their study as well as a full description of the scientific methodology they used, the CDC chose not to inform Alter and Lo that the CDC had a negative study in press. When the authors learned this information very recently, they were surprised."


July 8th,  The Independent in the UK reports of the NIH/FDA study being blocked This is the most interesting part of the story: 

"However, the CDC paper has been published online by the journal Retrovirology after intervention by senior virologists concerned about it being held up."
"However, scientists who have seen the FDA study have told The Independent that it is seriously flawed and should not be published in its present form because it cannot support its assertion of a link between chronic fatigue syndrome and XMRV."

"But in May, at a blood safety meeting in the Croatian capital of Zagreb, a respected virologist, Harvey Alter of the US National Institutes of Health Clinical Centre, gave a talk where he told the audience that he and his colleagues have independently confirmed the Mikovits' study, which is "extremely strong and likely [to be] true".

"It is this study, led by Shyh-Ching Lo of the FDA laboratory in Bethesda, near Washington DC, that was submitted to and initially accepted by the Proceedings of the National Academy of Sciences. However, when officials from the Department of Health and Human Services heard about it they took fright that it would contradict the only other American study into XMRV and the syndrome that was ready for publication, according to sources."

"Shelly Burgess of Proceedings of the National Academy of Sciences said: "The FDA/NIH paper has not yet been accepted for publication. The paper is currently undergoing a rigorous scientific review process."
The FDA declined to comment."

July 9th, the CFIDS Association of America (CAA) announces the FDA/NIH paper will be published within weeks. 
"The study pending from NIH/FDA attracted a lot of attention in June after news of its conclusions was leaked by a Netherlands news agency. The researchers have conducted additional experiments as requested by the reviewers and their paper is expected to be published in the Proceedings of the National Academy of Sciences within weeks."
July 9th CFS Central reporter Mindy Kitei 
"Sources to CFS Central say that the researchers' conclusions have not changed.  PNAS Editor Dr. Randy Schekman is on vacation and could not be reached for comment."

July 12th Mindy Kitei of CFS Central reports that newer version of FDA/NIH paper not accepted for publication yet.


"Dr. Randy Schekman, editor-in-chief of the Proceedings of the National Academy of Sciences (PNAS), where the FDA/NIH XMRV ME/CFS paper had been accepted, gave CFS Central an update.  The NIH's Dr. Harvey Alter, one of the authors of the study, told Schekman that he'll be returning the paper to the journal "within weeks."  After that, the PNAS editorial board will consider the paper, which, Schekman says, is "standard procedure."  The FDA/NIH study found the retrovirus XMRV in the majority of ME/CFS patients that it tested."

(This post will be updated regularly as the story unfolds)

2 comments:

  1. http://healthcare.change.org/petitions/view/xmrv_allow_science_to_progress#

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  2. Am I amazed or just appalled? Your first paragraph under the date July 8th says that "scientists who have seen the FDA study say that it is seriously flawed (etc)". But NO-ONE had yet seen the paper - except reviewers, who are bound to secrecy. Not only that, but the paper had already been fully peer-reviewed and was in galley-proof form, 99% ready for printing. Even worse, a respected scientist like Harvey Alter with a huge back-ground in HIV & retrovirology would never put forward an imperfect paper. We might wonder, but we don't, because we know that it's the higher-ups who don't want corroboration of the WPI results. Sadly, real science suffers. We all know the truth, but it has to be printed in a respected scientific journal before the world will accept it. It IS happening - it's just the delay that is costing people their health, lives, family, jobs, etc. The cause of ME/CFS was known to be a HIV-like retrovirus 26 years ago, by CT scans done by Cheney & Peterson - no debate about it. I'm just surprised that patient groups haven't stormed the White House waving pitchforks before now.

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