Chronology of the NIH/FDA and CDC Paper 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 Oslers 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of the National Academy of Sciences (PNAS), has been put on hold because it directly contradicts another as-yet-unpublished study by a third government agency, the U.S. Centers for Disease Control and Prevention (CDC).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 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 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. Its a matter of getting it right, he says

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. Alters 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 2nd, 2010 CDC calls its holding back of paper a strategic pause

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.

by Andrea Martell

(This post is still under construction as the story unfolds)
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