Tuesday, July 6, 2010


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 the 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.

The FDA/NIH study found the newly discovered retrovirus XMRV in most ME/CFS patients in a New England cohort that it tested, as well as in up to 7 percent of healthy controls.  That 7 percent would translate into nearly 20 million people in the United States and signals concerns for the safety of the blood supply.  As a comparison, 1 million Americans are living with another retrovirus, HIV/AIDS.  The Japanese Red Cross issued a disturbing report that XMRV has been detected in nearly 2 percent of Japan’s blood supply.  This year, Canada, Australia and New Zealand banned patients with CFS from donating blood due to the concern about blood safety.

Another government XMRV paper, this one by the CDC, failed to find any evidence of the retrovirus in patients or healthy controls and was published in Retrovirology July 1. The Wall Street Journal had reported on Wednesday, June 30 that both the CDC and the FDA/NIH papers would be put on hold until a consensus could be reached—or until it became clear how the agencies reached opposite conclusions.  But in an abrupt about-face, the CDC ended up publishing its paper on Friday, whereas the FDA/NIH paper remains in limbo.  CFS Central sources said that some scientists attempted to halt the release of the CDC XMRV paper to no avail.

On Friday, I asked the CDC's Dr. Steve Monroe, director of the agency's division of high consequence pathogens and pathology, why the CDC requested that the FDA/NIH study be held, and he replied in an email, "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.”

PNAS paper already in galleys
Highly placed insiders tell CFS Central that PNAS had not only accepted the FDA/NIH paper, it was in galley proofs when it was pulled.  After a manuscript is accepted and edited, it goes into galleys for review by authors and editors before being published.

Dr. Randy Schekman, the editor-in-chief of PNAS and professor of cell and developmental biology at the University of California at Berkeley, told CFS Central that he couldn’t comment specifically on any unpublished paper.  He advised talking to the NIH’s Dr. Harvey Alter, the principal investigator of the FDA/NIH study. Alter is best known for pioneering work in "non-A, non-B hepatitis," now known as hepatitis C.  Responding through a press officer, Alter said that the XMRV research data can’t be discussed until it’s published.

Randy Schekman said, however, that putting a hold on a paper is unusual and has occurred only one other time that he knows of in his nearly four-year tenure as PNAS editor-in-chief.  In that case, Schekman himself held up the paper, which was eventually published.  Precise in the way that scientists usually are, Schekman qualified, “But there may have been other examples handled by the staff that never rose to the level of urgency that required my attention.  A common example where I would not have gotten involved is when the author holds off in the interests of coordinating his or her paper with someone else’s paper, in the spirit of cooperation.”

Dr. Judy Mikovits
Dr. Judy Mikovits of the Whittemore Peterson Institute (WPI) in Reno, Nevada, was the principal investigator of the XMRV October 2009 Science study that found the retrovirus in 67 percent of 101 ME/CFS patients and 3.7 percent of controls. A July 2 WPI press release noted, “The methodology used by the CDC was not the same as that used in the WPI study nor was the patient selection criteria.  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.” 

Mikovits told CFS Central that the CDC wouldn't be able to find virus in the samples her lab sent.  “The CDC assays [chemicals used to do experiments] as published in Retrovirology would absolutely not detect XMRV in a human sample,” Mikovits explained.  “Switzer [Bill Switzer, the principal investigator of the CDC study] said in his paper that if XMRV were there, his assays would have detected it, but this is not the case.  There is a difference in the analytical sensitivity and the clinical sensitivity of an assay.  The simple fact is that the CDC’s assays have never detected XMRV in a confirmed positive clinical sample.  It does not matter the population, they could not detect XMRV if it was there.”

As reported on this blog, on Friday I asked the CDC’s Switzer in an email if he had tested the confirmed positive samples sent to the CDC, and, if so, did he find XMRV in them or not?  Switzer sidestepped the questions with this reply:  “As reported in Retrovirology, this study used and tested samples that were collected in CDC-sponsored studies of CFS, as well a set of healthy blood donors.  Continued efforts are underway to learn more about XMRV, including work with other HHS [Health and Human Services] agencies and non-governmental organizations to standardize testing methods across all XMRV studies.”

In his study, Switzer did not include that Mikovits sent positive XMRV samples to the CDC.  CFS Central has learned that two other labs have confirmed the samples sent to the CDC as XMRV positive.  In addition, CFS Central has learned that another lab sent the CDC blood samples that were positive for XMRV as well. 

Dr. William Reeves
Another of the CDC’s study authors is Dr. William Reeves.  After Judy Mikovits’s study was published in October, the then-head of CFS research at the CDC told the New York Times:  “We and others are looking at our own specimens and trying to confirm it.  If we validate it, great.  My expectation is that we will not.”  Reeves also told the Times that the likely culprits behind CFS were sexual and emotional abuse and an inability to handle stress.  During his two-decade tenure as the chief of CFS research, Reeves focused on psychiatric research into CFS, including his 2006 paper on CFS coping styles, which found patients guilty of “maladaptive coping” and “escape-avoiding behavior.” Reeves was transferred out of the department on February 14.

Dr. Walid Heneine
Still another of the CDC XMRV study authors is Dr. Walid Heneine.  Back in 1993, Heneine served as one of the CDC researchers conducting the study that attempted to corroborate the first paper to link CFS to a retrovirus. In 1991, Dr. Elaine DeFreitas of the Wistar Institute at the University of Pennsylvania wrote that paper that linked ME/CFS to a novel retrovirus, which was, ironically, published in PNAS.  (It’s not clear whether XMRV and DeFreitas’s retrovirus are the same, though preliminary evaluation indicates that they are not.) 

Twenty years ago, the CDC researchers weren’t able to replicate DeFreitas’s work and, as with the current study, they didn’t use the same methods and assays, prompting many patients, physicians and researchers familiar with the events of the past to feel a sense of déjà vu. 

In addition, the current batch of CDC scientists sent XMRV samples to the Robert Koch Institute in Germany for outside confirmation.  The Koch Institute didn’t find XMRV either, though some researchers believe that was to be expected since the Institute didn’t find XMRV in a 2009 prostate cancer study.  (XMRV was first detected in a virulent form of prostate cancer by American researchers back in 2006.)

Patients unite
Many patients report being appalled with the events of last week.  “The scientists at NIH and CDC are supposed to be just that:  scientists,” said patient advocate Dr. Mary Schweitzer, who has ME/CFS and is XMRV positive.  “In all avenues of scholarship, medical science included, disagreement is an expected part of the process—particularly in a new avenue of research. There should be nothing wrong with conflicting results from dispassionate scientists working on the same problem.  But the patients… are used to seeing politics, not science, from our public health agencies.

“After AIDS was recognized, American insurance companies took a serious hit because they had not prepared for the contingency that a new, deadly disease could emerge.  With CFS, they were facing the same thing—if the disease was recognized for what it really was.  We’ve had evidence of biomarkers, immune defects and active viruses in subsets of patients with CFS for two decades.  Each time, the CDC has done a quick study, declared that “Agent X” is not “The Cause” of CFS, and that was the end of funding, the end of publication, the end of the research.

“The CDC's website on CFS insists there is no relationship between CFS and abnormal Rnase-L [an antiviral pathway], chronic EBV [Epstein Barr Virus, which causes mono], abnormal natural killer cell function [immune cells that, as their name suggests kill pathogens], abnormal brain scans, and other tests and biomarkers that could have been used to identify subgroups of patients within the larger group of one million or more adults estimated to have CFS.  Why would that have made a difference? Because there were therapies and treatments that then could have been used to help those patients.

“Of course, private insurance companies, Social Security disability, and Medicare would have had to pay to take care of so many sick people, and they would have had to pay for their treatment. In place of a serious effort to define and treat subgroups of CFS patients, the CDC adopted the approach of British psychiatrists—indeed, CDC's website steers medical professionals to the UK for instructions on how to treat CFS.  Cognitive behavior therapy [a type of psychotherapy], graded exercise, and perhaps some antidepressants.  That’s it.

“This strategy perhaps made financial sense in the short run.  If XMRV does turn out to be a factor in even half the cases of CFS, that would be about as many people as have MS.  Again, if XMRV proves significant, it’s a little late to worry about getting it out of the blood supply:  That horse left the barn 25 years ago when the disease exploded in cluster outbreaks across the country.  But the CDC did nothing.

“And what about those of us who do have HHV-6 Variant A? What about those of us with the 37kDa Rnase-L defect?  That’s where former CDC colleague Suzanne Vernon’s comments
make one wonder.  According to Vernon, the samples used by the CDC team when searching for XMRV were stored in such a way that viral evidence would have been destroyed. They needed samples in green-topped, sodium heparin tubes. They were stored in something else.  That strategy, which would have ensured no virus was found, would have worked to ‘disprove’ the existence of defective Rnase-L and HHV-6, too.  Unless the samples were stored with a sodium heparin solution, the samples would have been useless.

“The longer the CDC insists that there are no tests or treatments for CFS, the sicker the patients get.  Some have already died of heart disease or rare cancers. The longer the CDC is permitted to pretend CFS is due to an abnormal stress response, the more people become infected with the underlying causes of the disease.  It is a remedy that is short-run smart, long-run stupid. After 25 years, the long run is here.”

Blood-bank demonstration
Some ME/CFS patients are demoralized over the FDA/NIH paper being pulled and the CDC paper being published.  Some are angry.  But there’s something new:  The birth of a powerful, organized, articulate, mad-as-hell-and-not-going-to-take-this-anymore brand of advocacy unleashed by the Internet.  Patients from all over the world are connecting in patient forums and on blogs, private messaging each other, planning their next moves.

One of those patients is W.L. Karns.  “Even after all the CDC has done over the years to suppress the seriousness of our illness, it’s still numbing to see them continue to spread disinformation disguised as research,” explained Karns, who’s had ME/CFS for 23 years. “The CDC ministers of propaganda who wrote the XMRV study are cunning.  They even released the study before a holiday, hoping to minimize the backlash they knew would follow.  I can’t tell you the anger I feel about the CDC’s continuous abuse and contempt for the people they’re supposed to be helping.

“Twenty-five years of willful inaction by the government when it comes to this illness have convinced me that patients must empower themselves like the AIDS patients did. Twenty years ago [AIDS activist] Larry Kramer and ACT UP [AIDS Coalition to Unleash Power] became fed up with the AIDS response by the government and conservative advocacy groups—including the Gay Men’s Health Crisis, which Kramer himself started.  They just weren’t getting anything done, and people were dying, like today.  The leading advocacy groups were too cozy with the government, and they cared more about their own welfare than the patients.  Then, ACT UP came up with an incredibly effective slogan:  Silence = Death.

“I propose we start a worksheet on [the patient forum] Phoenix Rising Wiki pages to plan, ask for volunteers and track demonstrations to increase public awareness of the situation.  Patients who aren’t bed-bound or house-bound can congregate outside the busiest blood banks and disseminate information to inform people that researchers have found a new retrovirus in people with ME/CFS, and that the blood supply is contaminated—but that the government is suppressing the information. 

“I believe we need to act quickly, before the FDA/NIH paper is killed.  Those of us who are too sick to go to the blood banks could get a family or friend to stand in their place.  For maximum exposure, we’d alert the media and hand out leaflets.  We could record the demonstrations and put them on Youtube, Twitter and Facebook.  That’s something ACT UP couldn’t do 20 years ago.  Let the message go viral—pun intended.  Surely the million of us in the United States and a quarter million in the UK and elsewhere can unleash the power of the media and the Internet to change things so the public and the government will finally hear us.  I’m tired of being barely alive, I’m tired of being invisible, and I’m tired of being silent.”  


To understand more about the CDC’s complicated ME/CFS history and XMRV research, see “Blood Feud” Part 1 and Part 2.  To read the CFS Central interview with CDC scientists on their XMRV study, see “Q and A with CDC Scientists.”

This article, “FDA/NIH Paper in Limbo; Patients Unite” is copyright CFS Central 2010.  All Rights Reserved. You may quote up to 150 words from this article as long as you indicate in the body of your post (as opposed to a footnote or an endnote) that the excerpt is from CFS Central.  You may not reprint more than 150 words from this article on blogs, forums, websites or any other online or print venue.  Instead, refer readers to this blog to read the article.


  1. "First you've got to get mad. You've got to say, 'I'm a human being, godammit, my life as value." (from the movie, NETWORK)


    The CDC and now, the HHS, with the help of the CFIDS Assn of America, has stolen my life, and they have left me with nothing left to lose. LOOK OUT, CDC, HHS and CAA!

    Patricia Carter

  2. You are walking point on this issue. Great straight reporting. Keep it up and you will be in the running for a Pulitzer... Well done...Medill would be proud.

  3. Thanks again for working so hard to uncover the facts. God, this is depressing.

    Here's my question. Though everything you've said is absolutely credible to anyone familiar with the CDC's history, unnamed sources are not proof, and you shouldn't reveal your sources for obvious reasons. So how do we obtain solid evidence that the CDC is working behind the scenes to suppress the NIH paper? We can scream all we want, but without proof, the population at large will fit us all for tinfoil hats and go on with their lives.

  4. To compound the effects of demonstration the protest could be coorperative and internationally-based. It would be good to attract the media's attention and get XMRV outside closed doors to create mass public pressure. I see it now, patients around the world uniting against the politics of neglect. We could gather all affected people...carry signs and banners...maybe wear black armbands to signify the darkness we were left in to suffer and in some cases die. Or maybe wear multiple colours...black, the colour yellow for cancer, the colour representing autism and other colours for associated illnesses....a rainbow of colour perhaps to show the world this disease is a biological illness and has been misaligned and misrepresented as tiredness and somatization.

    I think the protest must be global and patient groups should unite since the politcs of ME/CFS is bigger than the CDC and U./S government. This is a world issue like HIV and Aids. The FA and NIH paper is a key document and will lead reserach however, so there needs to be a focus on this first and foremost. Making noise is the idea here. Governments need to know people are watching and they have to behave accordingly. The lack of transperancy the past couple decades has been a dangerous thing in terms public health and a stategy to combat this is in order in view of XMRV developments.

  5. @ cinderkeys: Alter is the LIVING proof I guess, apart from any unnamed sources. He HAS written the words (that FDA/NIH have confirmed the WPI findings and were going to publish soon) himself on his slides he showed at the bloodbank-conference. Those slides are on the net.

    @ cfscentral: Although terribly dissappointed of course I for one am not very surprised the possibility is getting real that the FDA paper could be killed. That was my first thought to be honest. Sad but true.

    And yes, we should be MAD as hell now. We HAVE to take action this time. Global action if it was up to me. If there's one time we have to do the almost impossible for most of us: take action, it's now! Not later, not in a year, NOW!

  6. Thanks so much Mindy - such a significant story (with potentially global implications) - I am pleased at least one journalist is reporting it. According to the CDC criteria for the XMRV study – they excluded people with neurological symptoms. Years ago my partner was living a full and interesting life – writing a PhD at Oxford University when he developed a flu like illness-within weeks he was unable to read or comprehend basic sentences combined with a range of other disturbing neurological symptoms. 7 years later he is still mainly bed bound with ME/CFS (the ‘flu’ marked the beginning). Today he received his results – XMRV positive – and yet he would have been excluded from the CDC study. In fact – the criteria used would have precisely excluded the very people who are most likely to be XMRV positive. It is absolutely time to mobilize, expose the truth, and bring about a sea change in research and treatment.

  7. Just FYI, on the front page it says there are zero comments on the post. So some people may not be reading the comments.

  8. Hillary Johnson's evaluation of the recent actions regarding XMRV has been posted here:


    Dear Mindy, I hope you can get this series or a condensed version published in a major newspaper. The public deserves to know and needs to know.

    I think this sorry ordeal has convinced me of one thing entirely and that is that "Science by Bureaucracy" is even worse then "Science by Press Conference."

    The CDC has known about CFS for about 25 years and how many important papers have they published in that time to move the biomedical science forward; while people may disagree on the exact number it seems to me that it has been "less than ten" at most. Not exactly a good record.

    I believe in the future we need more academic and decentralized science institutions (such as WPI, a more widely known example being the Salk Institute) and decentralized funding institutions because these people, apparently once they become part of a bureaucracy lose a great deal of their conscience.

    From the various historical and contemporary accounts of fascist regimes we know that people, normally good & pleasant people, will find doing the morally right thing in some particular issue abhorrent because it would contradict the "institutional narrative" they have been submerged in.

    People tend to think of "Brave New World" or "1984" when they think about "institutional narratives" but I think that this is a sort of (for lack of a better word) "romantic embellishment" by those authors...

    ...Most group-think probably comes from accumulated attitudes and responses of the members of an institution over periods of time. It comes about "organically" rather than being artificially imposed by some sinister cabal. Despite the lack of a "sinister cabal" this group-think can still be just as divorced from reality and just as harmful.

    Also in science just like anywhere else it seems to be easy to fall victim to the "fallacy by authority." As people we are inclined to believe that someone is almost never "all wrong," rather that it is "wrong" in certain parts and this applies to likely all aspects of human life.

    ((I suppose we are a bit programmed this way because in the distant past disregarding any information was a good way to get yourself eaten or otherwise killed even if the information was known to be flawed.))

    Since guidelines by the CDC and NIH are used as standard practice in health-care this is an additional way government research institutions hold disproportionate power.

    Another would be hosting conferences on topics of their choice and being virtually guaranteed to be invited to any conference which on a topic relevant to their "mission" and therefore always have a "seat at the table."

    Bureaucratic group-think, at least on this subject, the case for our public health agencies. Things going against their institutional culture are shunned regardless of whether these things are moral to do or no.

    Speaking about the recent CDC XMRV "study" I think whether it is fatally flawed or not, the fact that the CDC has done so little research into the cause of a hugely impactful disorder is itself criminal. Indeed, as has been mentioned, a lot of their "research" seems to be making it so that the "CFS case definition" is as broad as possible, in fact using the "Reeves 2005 Criteria" or the "revised 1994 definition" as they call it would capture a large percentage people with chronic ill health for whatever reason.

    I wonder just how much influence the two scientists you mentioned had about designing the CDC's study? Why two such controversial figures? Why someone who said they expected the result to not hold up, even before they could have possibly known all that much about XMRV? At the very least it is terrible PR.

  9. Mindy, another question you will likely know the answer to:- the other pending positive papers, are these also government funded and therefore technically may be withheld by HHS?

  10. Since William Reeves was transferred, who at the CDC is responsible for using his vague fatigue definition for the XMRV study, and for the new CDC website information which overstates the results of the study?

    Also what level of HHS is holding the NIH study? It is hard to tell which directors are informed about CFS and knowledgeable about XMRV efforts within the agencies.

  11. Thank you!
    This is infuriating,
    but I'm so grateful for journalists like you who are bringing the situation to light.

  12. Peter,
    The other positive papers that I know about are not government studies.

  13. WantsToKnow,

    Reeves may have been transferred, but he is still listed as an author on the CDC XMRV study.

    As far as who in the NIH held up the FDA/NIH study, I put in a request to the NIH to get a response from the officials who, according to my sources, were involved. As soon as I get a statement from the NIH, I'll post that information on CFS Central.

  14. Trouble is, after a decades-long campaign by psychiatrists with vested interests to paint us all as hysterical attention-seekers I am sure a protest about cover-ups will just confirm that in the minds of much of the public at large. Plus all the usual ignorant "Oh, they're well enough to get out when they feel like it to protest then?"

    In recent years this has become one of the most crushing aspects of this whole disease and the politics around it for me, a real Catch 22 situation where anything we do will only confirm people's prejudices.

    Campaigning by our allies who cannot be written off so easily is vital. It's wrong that it should be that way, but there we go. This is why I am so very, very grateful for this blog and only hope there is a chance, in time, for the work here to get the mainstream attention it deserves.

  15. I know this sounds sensationalistic but do you think getting someone like Oprah on board would be of help??

  16. Ironic that the authors of thew FDA/NIH study (Lo and Alter) had to sign a form saying that they were not representing the views of their respective agencies (see H. Johnson's story) but that the CDC/HHS was still in control of what they would allow to be viewed by the science community and the public.

  17. maybe it would be easier to get research validated outside of USA?

  18. "...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."

    The statement above, quoted from your article, Mindy, is what worries me the most about this whole debacle. I could handle the paper just being "delayed," but it is inconceivable to think this paper might never be published at all, especially since the researchers who wrote it have such esteemed credentials. I am mortified--and ANGRY--that this could happen. It defies belief.

    Thank you for keeping "on top" of this controversy. We need good journalists tracking this explosive story.

  19. Mindy, thank you so much for your voice. This story is out of this world, and I can't believe that i am living it.

    Several of us are bed and housebound. Several have been so for decades. It is very difficult to imagine we could "walk out" and protest like the aids patients did.

    I wonder what can and should be done from our end.

    I wonder is we could use the power of social media to the best of its capacity in order to be heard.

    This is just not a US matter, it's international. The CDC decisions impact many countries out there.

    This is scary times. We can't just be burried in alive, again. I wasn't done with my life.



    Tell the DHHS to allow the NIH and FDA to publish their papers without undue procedures and hurdles. Preventing these papers from being published diminishes the trust of CFS Patient groups in the CDC and its willingness to deal honestly with this disease. To allow CFS patients and those with Prostate Cancer the best hope of fighting their illness, we must have the best scientific information that our government is capable of producing. Allow the findings to be released with all speed and tell the DHHS to stop playing politics with science.

  21. Thank you. Great comments too. I agree that it would be good to get documents or something more objectively solid than "sources." I hope this gets picked up elsewhere.

  22. It's time for those "Highly placed insiders"to accidentally leak the NIH/FDA paper...

    Another wild thought is that CFS patient organizations should hire protesters to go and demonstrate in front of the CDC. This is a perfect way to get attention and show how we are so ill with this disease that we require a proxy to protest for us.

  23. Mindy,

    Thank you for keeping updates coming and insuring this stays in front of people, we can't let this just fade away.

    It blows the mind that the Alter paper can be kept under wraps but until I see it, as it was sent to PNAS, I will not give the government the benefit of the doubt, look where that's gotten us so far. Is it possible to obtain this work from a freedom of information act request?

    I hope that Alter won't be duped into exchanging samples with the CDC, if they have killed off the virus by improperly drawing/storing their samples NO ONE can find a virus in them.

    Folks, this is our paper - we paid for it.



  24. hi every one ,
    from former experience being a political activist in the 80 i know that in every campaign comes the moment where playing it nice does just not work anymore.
    Steel the damn papers and offer them and the story to any of the major new agencies!
    a very angry ME/CFS sufferer

  25. End the "CFS" cover-up! I've had M.E. since Jan 03, 1975, and I am extremely angry that the CDC has not dealt with this disease honesty and I am much more ill and will be dying as a result! Meanwhile, millions more are suffering like I have! Please permit the NIH and FDA papers to be published, or soon nobody in America will trust the CDC!

  26. Getting Oprah on board would be a huge help, especially if a well-liked celebrity with CFS would come forward to help educate the public and raise the profile of this misunderstood disease. Think Michael J. Fox and Parkinson's.

  27. i also........am very sick too,(25+ yrs + pos xmrv from WPI) ....NOW, not able to do much protesting in the streets,
    **BUT I WILL SAY......keeps the emails flowing !!!!
    to all your senetors & reps from y'r state & others.

    I LIKE SO MANY OTHERS.......!!!!
    " For the Truth shall set u free "

  28. nothing was smart about the short term CDC "solution" of burying their heads in the sand. how could they not have known that the infectious agent would continue to spread and eventually cause a much much bigger global crisis?

    the only positive that can come of this, is that treating everyone will be so costly in addition to all the HIV cases, that the search for a retroviral cure might get a big push.


  29. Thank you Mindy, for this amazing reportage!! I learned a lot- such as that CDC requested the paper be held!

    Dr. Alter was quoted in the Ortho press release that started all this that "XMRV and related MLVs" have been found in the blood supply at 3-7%, meaning (at least to this layperson) that in addition to the confirmation of XMRV in ME and normals, that the discovery of additional new human retroviruses were discovered in the FDA/NIH study!! One more reason for CDC to sabotage publication. And the Band Played On.

    -Justin Reilly


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