FDA/NIH XMRV paper ON HOLD

[justinreilly]

These govt groups are not sitting around saying 'how can we continue to hinder progress in CFS research?'

Kurt,

You know very well that obstructing science on ME is practically their full-time job!! Statements like this are very misleading for people who don't know the history of these agencies. Please do not post untruths like this!

 

[Dr. Yes]

Based on your evident knowledge of medical/public health research, I accept that your assessment of what is going on with HHS/NIH/CDC is correct. I didn't mean to negate your experience. I was simply astounded that your lab experience is so different from mine. :Retro smile:

Kurt, perhaps full disclosure, as you did once before, of the extent and type of your involvement in 'government research' would prevent past overestimations of your level of experience from being repeated. With all due respect, Dr. Coffin likely has a great deal more experience in this subject than you or I do, and his opinion on just how "unusual" this action is quoted in the WSJ piece.

There are major differences between how research is handled in military versus non-military government agencies. I have personal experience with a research proposal to NASA and with scientists at NASA-Ames Research, where the scientists potentially have zero control or intellectual property rights to their studies; everything they produce is vetted by several layers of organization and security and is usually initially classified and owned by the US government. That is a far cry from what happens at the NIH or the CDC; I have also spoken to Dharam Ablashi (co-discoverer of HHV-6) when he was a scientist at the NIH, and am fairly familiar, thanks to him, with the level of political obstruction and bureaucracy there. But nothing he described comes close to what is going on here. This action is absolutely, emphatically not business as usual for the DHHS. If you can think of a comparable example, please share it.

 

[Sean]

So what ever one says about cooler heads and reason, history has shown that politics trumps truth.

It certainly tends to in the short term, but not in the long term.

 

[kwietsol]

Kurt, perhaps full disclosure, as you did once before, of the extent and type of your involvement in 'government research' would prevent past overestimations of your level of experience from being repeated. With all due respect, Dr. Coffin likely has a great deal more experience in this subject than you or I do, and his opinion on just how "unusual" this action was is quoted in the WSJ piece.

There are major differences between how research is handled in military versus non-military government agencies. I have personal experience with a research proposal to NASA and with scientists at NASA-Ames Research, where the scientists potentially have zero control or intellectual property rights to their studies; everything they produce is vetted by several layers of organization and security and is usually initially classified and owned by the US government. That is a far cry from what happens at the NIH or the CDC; I have also spoken to Dharam Ablashi (co-discoverer of HHV-6) when he was a scientist at the NIH, and am fairly familiar, thanks to him, with the level of political obstruction and bureaucracy there. But nothing he described comes close to what is going on here. This action is absolutely, emphatically not business as usual for the DHHS. If you can think of a comparable example, please share it.

Yes, Dr. Yes!

And thank you.

 

[Hope123]

Well, this doesn't strike me as "business as usual" government lab or not. I can well understand the FDA/NIH and CDC not communicating with each other over studies as governmental agencies might not be well-coordinated but to then have DHHS decide at more of less the last minute to have both studies held for publication makes me suspicious (and I am not much of a conspiracy theorist).

Kurt, IIRC, your area of expertise is not biology or its related fields. While you are obviously welcome to comment about your governmental experience (and have contributed good comments on studies), what occurs in one governmental area might be different from another. Having experience in academic/ private/ community-based/ govermental healthcare sectors, I know the culture for each one differs even within one field.

 

[glenp]

Thank you for posting this Muffin. Its important that we see this. It helps to prevent it and the Dr. Freitas discovery from being ignored again. They will have a harder time ignoring it if we continue to post and inform people - it will not be as easy now that we have the internet

glen

The Tuskegee Syphilis Experiment http://www.infoplease.com/ipa/A0762136.html

 

[judderwocky]

i have to agree... this NEVER happens in science... to toy with something that should be in print is BEYOND reprehensible.

 

[judderwocky]

I worked in government research labs, too, and family still does. Papers were vetted in-house before they were sent for review and publication. The idea was that if the work was not considered suitable for publication it was held before it was sent to publishers. This is as much a matter of courtesy as a desire to withold information. Putting the publication and the peer-reviewers through the work involved in preparing the paper for publication and then pulling the paper afterwards is not respectful of our professional colleagues.

I'm not denying your experience. You probably worked in a bigger lab than I did, and in a different technical area, so policies could be different depending on the circumstances. I do not doubt that your agency worked as you said. Nevertheless, I still find it surprising that they would wait until after the paper has been in the hands of peer-reviewers and publisher's staff before they would review it in-house for issues that might reflect on the agency. But then, lots of things surprise me, so this is nothing new. :Retro smile:

So, this is not how science works in all government labs, certainly none that I worked with routinely, but I bow to your experience in a government lab and acknowledge that it may work that way in some, or perhaps even many, government research labs. Sad.

Based on your evident knowledge of medical/public health research, I accept that your assessment of what is going on with HHS/NIH/CDC is correct. I didn't mean to negate your experience. I was simply astounded that your lab experience is so different from mine. :Retro smile:

"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 "
- Vincent Racaniello Ph.D., Professor of Microbiology at Columbia University Medical Center

When any of those layers affect what should be published... then that is POLITICAL and not science. I have worked in a number of research labs myself... across a bunch of different fields. This sort of interference is beyond the peer review process. TO interefere with that is to toy with the fundamental ethical considerations of science. End of discussion.

 

[alex3619]

Hi Melodie,

I have moved this to a new thread. Actually, it took only about an hour to write. I think I do things differently to most of us. I think about it for many weeks, think about it with every new post I read on forums, and when I am ready I know what I want to say, I just have to type it and iron out the little problems. I have been thinking about this post since April (before I even joined PR), and just waiting for the publication of a verification study or something similar. The DHHS debacle was the trigger for me. I still have to track down every single politician I want to send it to, that might take a day or three anyway. Then I will have to decide which Australian media outlets are reputable enough to be able to do a fair job of research if they are interested.

Here is the thread:
http://www.forums.aboutmecfs.org/sh...-Australian-Health-Minister&p=97645#post97645

Bye
Alex

Hi Alex

You must have been up all night drafting this?!! Overall IMHO I think this is basically very good and that it should have its own thread as it is likely to be overlooked here. I have read it only once and can barely read at the moment let alone critically so am not in a position to make any constructive comments.

Thanks

Melodie

 

[glenp]

Sickofcfs - Thank you for clarifying how most labs work

It is beyond me how a negative study is published when contradictory results are known and then a possitive study is not. To me this is the key that something is VERY WRONG. If the Dutch negative study had also been held back I woud be thinking differently This is NOT right, not consistent

glen

glen

 

[alex3619]

Hi glenp

I think I am as annoyed as the rest of you. This is not how science as done, and if it is considered usual then the usual is very wrong (which is often the case in government).

However, the DHHS has overarching responsibility for all three research groups, if I am understanding the commentaries correctly. The NIH and FDA are saying one thing, the CDC is saying the opposite. That is why there is a delay, because they haven't figured out yet that something is very wrong at the CDC. My view is that they should encourage all to publish, and let the scientific debate sort it out.

The good news: we finally have DHHS interested in the outcome, and not ignoring us.

Bye
Alex

It is beyond me how a negative study is published when contradictory results are known and then a possitive study is not. To me this is the key that something is VERY WRONG. If the Dutch negative study had also been held back I woud be thinking differently This is NOT right, not consistent

glen

 

[Melodie]

This is at post #170:

From the CAA on Facebook:

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

For more information please see http://www.cfids.org/xmrv/default.asp

ETA: Note that according to the WSJ article, the spokesperson for the journal says it was accepted for publication. The Science article also indicates it was accepted for publication.

I wonder if there was a date given for the statement.

 

[glenp]

I agree publish all. That is the only way we are going to find out. Obviously some are doing the testing differently. Denying it is absurd. I do not know how they are able to do this legally? Do we have any lawyers here?

glen

 

[usedtobeperkytina]

If it has already been said, sorry.

Don't worry that it isn't published. Thanks to good journalism. We know and other researchers with an interest know. It is in the history books, waiting for the next book from Hillary. Only this time, I hope the ending is different. Either way, it is out.

Secondly, I think we may have found a new ally. Remember when the three stooges worked with the same goal Strauss, Wessely and Reeves? (I don't know if they were all in position at the same time, I am speaking of their attitudes, concurrent or not) Welcome to the stage Dr. Alter. Don't you just know he is hot now. His study, which he reported on at a conference, which was put out to the public, which he then confirmed to a journalist is approved for print, has been pulled. Not because of a problem with his study or methods, but because CDC disagrees.

Alter, just follow the rabbit and he will take you into the hole of CFS land. We have many characters here. Watch out for the mad hatter, he's goofy. And the queen, forget about it. It's a whole different world where we live.

Tina

 

[BRCforME.org]

Anyone else wonder what the G8/G20 would have looked like if the NIH/FDA study had been published?

 

[acer2000]

Sources also say that the CDCs study, which utilized both antibody testing and PCR testing, did not find XMRV in any of the ME/CFS patients it tested. In addition, the CDC tested 22 independently confirmed positive controls from different labs, but in the CDCs experiment none of those confirmed 22 was positive. The CDC also tested negative controls and found them all negative as well.

If they couldn't find it in 22 samples from "independently confirmed positive controls from different labs" - wouldn't that mean that their particular methodology isn't able to detect XMRV at all?

You'd think that even if they weren't able to find it in their cohort of patients, if their test worked they would be able to find it in samples already known to be positive... I wonder what those 22 samples are and where they are from.

 

[Sean]

Hi Sean

But this doesn't mean we shouldn't be applying public pressure. Business as usual can still be challenged.

Bye
Alex

No argument there. I am not saying they are handling it perfectly. Just saying that there is no need to waste precious time and energy (and frankly, credibility) pursuing conspiracy theories to try to explain this situation.

 

[bullybeef]

According to this short blog: http://www.prohealth.com/fibromyalgia/library/showarticle.cfm?libid=15447 the HHS wish to know why the CDC didn't find XMRV at all. Maybe we have it backwards and they're becoming suspicious of the CDC intensions.

Maybe the HHS also believe the NIH/FDA study could be too inflammatory for the general public.

 

[Marco]

I appreciate that we can't be sure of the contents of either of the 'embargoed' papers, but from the littlle we know or suspect, I find it difficult to believe that CDC were intending to go to press with a paper that basically stated that they found NO evidence of XMRV in either CFS patients, healthy controls, known positives and known negatives.

First off CDC cannot try to pretend that XMRV doesn't exist. That genie is well and truly out of the bottle and isn't going back in.

The question then comes down to issues of prevalence, transmission, disease association and causality.

I'm not convinced that the expected CDC findings are consistent with any anti-ME/CFS agenda. Details have already been posted of Switzer's earlier findings of no active XMRV in protate cancer cases. It has also been noted that this is CDC's retrovirology branch not the CFS team. Conclusively, finding XMRV in equal proportions of PWME/CFS and healthy controls would be more consistent with a CFS related agenda.

Infection has already been shown by the 'monkey studies' so the isssue then becomes one of prevalence.

I could easily understand that CDC might be a little embarassed that they missed a new human retrovirus that is now being found in high percentages of the general population, so it would suit their purposes to be finding low numbers. But not finding even known positives clearly makes it an issue of methodology.

I would assume that the CDC team working on this would as a matter of course keep themselves abreast of developments in the field. It has already been stated that the CDC study started relatively early, but if people on this forum are able to source information that suggests the virus is hard to find and that you need to be looking in the right place, you would expect CDC to be aware of this also.

So, being in possession of a paper which clearly states that you found no evidence of XMRV in patients and healthy controls, plus were unable to detect even known positives, and that evidence was emerging that you needed to use specific methods and look in particular places, would YOU submit the paper for publication?

If it were me, at the very least, I'd report the study findings, but with a very large caveat that the findings need to be considered in light of methodological issues which emerged after the study started. At least that would allow CDC to retain some credibility.

And then you find out that NIH and FDA teams have both independently found XMRV in even higher proportions of the general population than previously reported.


Perhaps the delay is to allow the CDC team time to add these caveats?

 

[taniaaust1]

Who's "Us" and who's "them"?
I dunno, I kinda like it. Firstly, let's take a look at who's "us" and who's "them". If I were a very very senior official in the US Gov't, I'd want "us", i.e. the U.S. gov't - with its many tentacles - to "win" this international race. I'd already have a sense of urgency from certain (um) videos and (um) powerpoint presentations etc, and I'd be damned if our country didn't make a mark in history. I'd want to snuff out as much of the CDC embarrassment as possible (CYA indeed), and I'd see the best way to do that would be to speak with one voice, and provide solid, scientific explanations for discrepant results. These explanations would no doubt also be helpful to snuff out the silliness from the UK and the Dutch (as Austin Powers' dad would say).

I'd be totally pi$$ed off at interdepartmental fiefdoms. I'd be issuing edicts to the paeons to get their frigging act in shape, and noncompliant heads would indeed be rolling. Sort out those reasons for discrepant results, I'd insist! Don't add to the mass confusion from across the pond that the media is just feeding on. I would have zero tolerance for nostalgic continuation of the CDC's love-affair with psychogenic claptrap. As Mindy Kitei said in her latest article,

If the CDC had found the retrovirus, it would have negated its 20-year affair
with CFS as a psychological problem.

​

This nostalgia would have no place in my roll-out strategy. Bottom line, to an ambitious, strategic-minded, senior senior gov't official, I'd have no patience for that garbaggio. I'd want an orchestrated, organized, unambiguous roll-out of XMRV testing and research, not hobbled by conflicting results that the media could devour and regurgitate to muddy the waters. I'd blow away the smoke and smash the mirrors. I'd demand cross-testing of a subset of the FDA/NIH and CDC samples. I'd want any discrepancies ironed out, and NOW! I wouldn't want any impediments to a smack-down roll-out of diagnostics and clinical trials. I'd want the US Gov't to be in front. And yes, I'd be VERY mindful that anything less than a home run would be just another festering sore in the sordid history of ME/CFS at the hands of the inept (and that's being generous) CDC. I'd want to cover my a$$ by showing responsibility in the face of 3 decades of neglect and embarrassment by the CDC.

As I said, I kinda like it. I believe it is in our interests as patients to have SOME powerful entity come out with a home-run. Might as well be the US Gov't speaking with one voice, at the behest of the HHS. And explaining away the failures of the CDC - while highlighting just why the "other" new positive studies are so good (eg. knocking that APOBEC distraction junk to the scrap heap) would be exactly what I'd be looking for. The last thing I'd want would be more confusion. I'd insist that the go-forward XMRV strategy be unfettered by confusion. And as George (good dog) rightly pointed out, I'd be bracing for a massive onslaught of voracious media interest and public outcry. As Forbin rightly said,


In short, I think it's all good. We've had enough obfuscation. We need clarity asap, and I'm OK with backroom organization if that's what's required to blow this ambiguity about XMRV out of the water. My instinct is the US Gov't - and many others - are in quiet panic mode now. And so they should be. It's about "bloody" time.

Now back to my rawhide bone.

Thanks. I loved your post, gave me a different view of looking at it.