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ONE WEEK LATER: Outrage Over Suppression of FDA-NIH's Positive XMRV Paper Despite July 1 Publication of Negative CDC Paper

  [ 157 votes ]   [ 3 Comments ]
www.ProHealth.com • July 6, 2010


On Thursday, July 1...

The US Department of Health & Human Services chose to allow publication of the CDC’s negative paper(1) (reporting failure to find XMRV in any CFS patients' blood) while the NIH-FDA’s positive paper reporting XMRV in CFS blood samples - which was to be published by Proceedings of the National Academy of Sciences - was cast into limbo.


"CDC Team's XMRV-Chronic Fatigue Syndrome Paper is Out," wrote Wall Street Journal health reporter Amy Dockser Marcus at 5:03 PM EST, July 1. At the same time, she noted, NIH spokesman John T. Burklow said "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."

Dockser Marcus also quoted WPI President Annette Whittemore, who urged immediate publication of the FDA-NIH paper, to "let the science speak for itself."

Note, in the Reader Comments on the WSJ article: a quote from Suzanne Vernon, PhD, Scientific Director of the CFIDS Association, faults the CDC study methods, stating, "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."

To read Dr. Vernon's full critique of the CDC study, see her article "Blood from a Stone," published July 1 on the CFIDS Association website.

On Friday, July 2...

According to a Whittemore Peterson statement posted July 2, "In September 2009, WPI sent the CDC 20 confirmed positive samples and the appropriate methodology to help them develop a clinically validated test. However, this team chose not to do this."

On Saturday, July 3...

Mindy Kitei posted a "Q&A with CDC Scientists" on her CFS Central blog site. She asked pointed questions of Bill Switzer, lead author of the negative paper, and CDC viral diseases division director Steve Monroe via an e-mail exchange handled by a CDC press office middleman. She received deflective non-answers in return.

On Tuesday, July 6...

Kitei reported more damning intelligence. The FDA/NIH paper had not only been accepted for publication by PNAS but was edited and already in galley pages for proofreading when it was pulled, Kitei reportedly learned from HHS insider "sources." Who also informed Kitei that blocking the paper was ultimately an HHS decision made at the CDC's request, and advised, "HHS can keep any government study from being published, no matter how solid."

See also Cort Johnson's play-by-play coverage on the Phoenix Rising Website: the July 6 post being “XMRV SampleGate at the CDC?”

Patients urged to support efforts to explore XMRV further. As Dr. Charles Lapp stated July 6 in his Hunter-Hopkins Center ME-Newsletter:

“So the XMRV issue remains controversial and “up in the air” much as the retroviral issue was in the late 1980’s when we first discovered retroviruses in PWCs. Research was stifled at that time by opposing factions, and it has taken over 20 years and the resources of the Whittemore-Peterson Institute to bring this intriguing possibility back to light. We urge patients everywhere to support efforts to explore XMRV further. Ways you can help are:

• Donate a specimen of your precious blood to the SolveCFS BioBank. Click here for details.

• Support the CFIDS Association of America. This group has worked tirelessly for almost three decades to promote scientific research about Chronic Fatigue Syndrome.

• Donate to the Whittemore-Peterson Institute so that they can pursue this important lead to the bitter end.

On Wednesday, July 8...

Mindy Kitei reports she emailed the NIH press officer "asking about getting a statement from the HHS officials who put the hold on the FDA/NIH paper." He responded that he hoped to have an answer "ASAP." Nothing yet. Regarding patients' questions about how to effect change, Kitei reviews the 1996 CDC financial improprieties scandal and invites patients who contracted ME/CFS after a blood transfusion to contact her.

On Friday, July 9...

The FDA/NIH paper will be released "within weeks," according to the CFIDS Association. Specifically, a post on their Facebook page notes that "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." Though no source was cited, the CAA later posted that "The information comes from several well-informed people close to the study with whom we are in regular contact."

If you're like us, you may want to attend and ask questions in the CAA's July 15 XMRV webinar.

____

1. Following is an abstract of the CDC paper, which reports their failure to find XMRV in CFS patients’ blood, published online July 1 by the journal Retrovirology. A link to the full text article is included.

* * * *

Absence of evidence of Xenotropic Murine Leukemia Virus-related virus infection in persons with Chronic Fatigue Syndrome and healthy controls in the United States – Source: Retrovirology, Jul 1, 2010

William M Switzer, et al.

[Note: To view a pdf of the article, click here.]

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.

Source: Retrovirology, Jul 1, 2010; 7:57. doi:10.1186/1742-4690-7-57, by Switzer WM, Jia H, Hohn O, Zheng H, Tang S, Shankar A, Bannert N, Simmons G, Hendry RM, Falkenberg VR, Reeves WC, Heneine W.




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Article Comments Post a Comment

Excellent Info
Posted by: Elisa
Jul 1, 2010
Thanks for keeping us up to date! Excellent reporting! Elisabeth
Reply Reply

Excellent de-bunking
Posted by: IanH
Jul 2, 2010
The history of this illness will prove to be an outstanding example of political mischief.
Reply Reply

 
Polital Mischief,,,,
Posted by: Shirl_M
Jul 7, 2010
I have been saying that for some time now, since this illness is sooo very strange... as is the fibro that often goes with it... I you would, could you be a bit more specific in your meaning, to see if we are "on the same page" as it were? Thank You,

 

 
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