FDA/NIH XMRV paper ON HOLD

[George]

State of Play

A recent grad student blog talked about media publishing results of positive and negative studies and creating an environment of distrust regarding scientific research. She called on the media to look at the 'state of play' or where things are really at. I can certainly understand the frustration from people in the research community. (big grins)This week Spinach will make you grow big and strong, next week Spinach will kill you.

Several weeks ago, I posted somewhere, that the reason there is no news (at that time) is because the PTB's had figured out the XMRV and CFS/ME are the real deal and were now doing what any good government agency is wont to do in times like this . . . CYA. (grins) No but seriously they do need to get things in order before releasing information into the public sphere where it will be picked up by the media. Because once it's out there, there is no taking it back. And it's going to get a little crazy. People will want a test, NOW, they are going to want to talk to there doctors about this, NOW (boy that's going to be reallllllly interesting.) They are going to want to know what it means if they are positive, NOW, they are going to freak because it can be passed on to children and given to partners and most of all people are going to want treatment NOW! This is the current 'state of play'.

If I had all that to deal with I'd be trying to by some time as well. Information has to be gathered, testing has to be set up, training has to get started and drug trials will have to be started. That's a lot of logistics!

So I'm just hangin out and I'm not worried. Why am I not worried? Cause I just watched a couple of , er, um well videos and in those videos the science had moved on from figuring out if XMRV is linked to CFS to how does the disease mechanism work. That tells me that behind the scenes the information is being shared with the people who are going to be cooking up the treatments for us down the road. The only place the information isn't being shared is with the public right now.

I give it two months, tops before release just has to happen. The pressure from the outside is going to out weigh any opportunity to stall for more time. (head shake) Nothing makes the reporters hotter than a perceived cover up. The longer the DHHS holds out the more the news hounds are going to dig! Gotta love em.(grinnin' from tooth to tooth)

 

[dean]

"at least an explanation of how and why the papers reached different conclusions, said the people familiar with the situation."

I am sure this is the reason for the requested hold. This is what I would want to know if I was a " senior public-health official" responsible for making national policy on CFS. The issue is too important and they know it. Way above the level of CDC.

 

[Mindy Kitei]

Hi all,

I've just posted an article that comments on today's Wall Street Journal piece.

Mindy Kitei
CFS Central
http://www.cfscentral.com

 

[ixchelkali]

Is Switzer even a Ph.D or a trained retrovirologist?

Yes. He's a microbiologist and he discovered two of the HTLV virus strains, according to his bio on the CDC website. I don't think he's a lightweight, even if he's an MPH rather than a PhD.

 

[ixchelkali]

IS this a political move? I can't imagine that top-tier researchers would let politics over-rule their studies.

It does happen. It happened with the AIDS epidemic and it's happening today. Check out the Union of Concerned Scientists webpage on scientific integrity and abuses of science. http://www.ucsusa.org/scientific_integrity/abuses_of_science/

I hope you're right that this represents a dedication to good science, but I don't think good science is best served by avoiding the give-and-take of published research. By publishing, they open the research to scrutiny by the whole scientific community. I think that's more apt to ensure good science than taking it into the back room.

I suspect there may be a lot more CYA going on in that back room than scientific inquiry.

 

[natasa778]

holding BOTH studies tells me they are really perplexed, so now they want to review and make sure both studies represent good science, before releasing them.

WRONG! The studies have already been peer-reviewed. Unless government officials want to play Gods of peer-review. Are they going to start judging the peer-reviewers now???!!! Un____ believable!

 

[ixchelkali]

A recent grad student blog talked about media publishing results of positive and negative studies and creating an environment of distrust regarding scientific research. She called on the media to look at the 'state of play' or where things are really at. I can certainly understand the frustration from people in the research community. (big grins)This week Spinach will make you grow big and strong, next week Spinach will kill you.

Several weeks ago, I posted somewhere, that the reason there is no news (at that time) is because the PTB's had figured out the XMRV and CFS/ME are the real deal and were now doing what any good government agency is wont to do in times like this . . . CYA. (grins) No but seriously they do need to get things in order before releasing information into the public sphere where it will be picked up by the media. Because once it's out there, there is no taking it back. And it's going to get a little crazy. People will want a test, NOW, they are going to want to talk to there doctors about this, NOW (boy that's going to be reallllllly interesting.) They are going to want to know what it means if they are positive, NOW, they are going to freak because it can be passed on to children and given to partners and most of all people are going to want treatment NOW! This is the current 'state of play'.

If I had all that to deal with I'd be trying to by some time as well. Information has to be gathered, testing has to be set up, training has to get started and drug trials will have to be started. That's a lot of logistics!

So I'm just hangin out and I'm not worried. Why am I not worried? Cause I just watched a couple of , er, um well videos and in those videos the science had moved on from figuring out if XMRV is linked to CFS to how does the disease mechanism work. That tells me that behind the scenes the information is being shared with the people who are going to be cooking up the treatments for us down the road. The only place the information isn't being shared is with the public right now.

I give it two months, tops before release just has to happen. The pressure from the outside is going to out weigh any opportunity to stall for more time. (head shake) Nothing makes the reporters hotter than a perceived cover up. The longer the DHHS holds out the more the news hounds are going to dig! Gotta love em.(grinnin' from tooth to tooth)

Thanks, George. I like your take on it. It's plausible enough to believe, and reassuring. If you're right, though, I think we need to keep up the pressure from all directions. Contact our elected representations, news agencies, etc. Make sure people are watching.

 

[pollycbr125]

:Retro mad::Retro mad::Retro mad:

What the hell is going on?

In an email between scientists familiar with the situation, viewed by the Wall Street Journal, a researcher said the two teams were asked to put their papers on hold because senior public-health officials wanted to see consensusor at least an explanation of how and why the papers reached different conclusions,

public health officials want to see negative papers more like not consensus as stated . Simple explanation if you dont look for the virus properly or use patients with a dodgy me/cfs diagnosis you aint gonna find XMRV . If you do it by the book like WPI you do . When is this bullshit gonna end . Ive just go up this has put me in a bad mood for the rest of the day grrrrrrr

:Retro mad::Retro mad::Retro mad:

 

[parvofighter]

I dunno - I kinda like the "Hold"

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,

Sounds like they are concerned about the public reaction when the country discovers that 3%-7% of the population may be infected with a retrovirus. Good.

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.

 

[parvofighter]

Intellectual property rights

Oh yeah, and as The Government, I'd want to be first-to-bat to patent intellectual property rights for as much of the diagnostic processes, testing, assays, etc as possible, so I wouldn't necessarily go broke trying to diagnose and fight this virus.

 

[bullybeef]

Great response as usual, Parvo, and I don't feel that worried about this either.

I do have a couple of open questions though, how can the CDC paper be positively peer reviewed if the methods to locate XMRV has come into question. If they used PCR alone, it should have been thrown out.

Also, William Switzer was mention anecdotally by Dr. Mikovits in one of her lectures. She showed him the virus, proved it wasn't a contamination, and he congratulated her. He knows XMRV is there, so why hasn't he found it?

 

[Dr. Yes]

So none of these government agencies had any clue that they had conflicting findings until after they submitted their papers? I find that hard to believe. Perhaps there is a major concern in the DHHS about public reaction to this news, and about 'getting to the bottom' of this issue, but if that were the case they would not have waited until after the peer review process to instruct the authors to delay publication. I'm afraid I am less sanguine about this than my favorite canine optimists. :Retro wink: It seems more likely to me that there is a political struggle going on between the CDC and everyone else. The XMRV Taskforce is an interagency effort; I never understood why the CDC sought to do its own study... surely the higher-ups knew that such a separation of efforts could lead to different findings. But there is no good scientific reason to suspend the publication of conflicting results, and it is unethical to interfere with the scientific process for political convenience when so many sick people depend on the results of a pure scientific process. Either there has been a great deal of incompetency/ lack of oversight until this late stage by various officials, or there is a power struggle going on.

The danger with allowing government agencies to work this out behind closed doors is that the CDC or their higher-ups could pressure the other group into editing (or, far less likely, even pulling) the positive study. To believe that government scientists are immune to pressure by the government is naive. It would be a mistake for us to relax and trust the government to do the right thing when experience tells us they are more likely to do the opposite. I think the best thing for us to do is put public pressure on the DHHS to allow the release of the FDA/NIH study (in its original accepted form) now; writing to the DHHS, to Congressional representatives, and attempting to get media coverage on this story could only help, in my opinion.

 

[Forbin]

Separately, scientists at the CDC, led by microbiologist William Switzer, concluded in a paper in another journal, Retrovirology, that they couldn't find XMRV in the blood of people with chronic-fatigue syndrome, according to people familiar with the situation.

Notice that it doesn't say that the CDC couldn't find XMRV. It says the CDC couldn't find XMRV in the blood of CFS patients. What about in the blood of their healthy controls? Perhaps this is just an oversight of the article, but it seems impossible that the CDC tested only CFS patients. Did the CDC find ZERO XMRV in everyone? That would be pretty suspect, just as in the other studies. But, would they really hold up publication just because the CDC couldn't find it in CFS patients if they did find it at background levels in the healthy population? I doubt it. I don't think it's CFS that's worrying them at the moment. This really suggests that the CDC found nada, which, as I say, is really suspect.

Also there's this:

...senior public-health officials wanted to see consensus...

To quote the late author (and M.D.) Michael Crichton:

"Let's be clear: the work of science has nothing whatever to do with consensus. Consensus is the business of politics. Science, on the contrary, requires only one investigator who happens to be right, which means that he or she has results that are verifiable by reference to the real world.

"In science consensus is irrelevant. What is relevant is reproducible results. The greatest scientists in history are great precisely because they broke with the consensus. There is no such thing as consensus science. If it's consensus, it isn't science. If it's science, it isn't consensus. Period."

"If it's consensus, it isn't science. If it's science, it isn't consensus. Period."​

 

[George]

CDC was goose eggs all around.

 

[bullybeef]

Maybe this could explain why the FDA/NIH paper was leaked, so we all got wind that their study was positive before the CDC tried to thrown a spanner in the works.

I’d would also like to think the media like the WSJ, whom has bee actively reporting on all things XMRV, are going to start getting bored with keep printing articles to the contrary.

Within a week we have had, “Further Evidence of an XMRV-Chronic Fatigue Syndrome Connection?” and now “Chronic-Fatigue Link to Virus Disputed!”

 

[bullybeef]

Maybe this could explain why the FDA/NIH paper was leaked, so we all got wind that their study was positive before the CDC tried to thrown a spanner in the works.

Id would also like to think the media like the WSJ, whom has bee actively reporting on all things XMRV, are going to start getting bored with keep printing articles to the contrary.

Within a week we have had, Further Evidence of an XMRV-Chronic Fatigue Syndrome Connection? and now Chronic-Fatigue Link to Virus Disputed!

 

[thegodofpleasure]

The clock is ticking

Pehaps Cort could place a counter on the PR homepage / XMRV buzz page, highlighting the length of time it takes these comfortably placed Government Officials to get their act together and finally publish the information we crave ?

There's a free one available at http://www.clocklink.com/gallery.php?category=COUNT

By the way, it's now been 265 days (or 8 months & 22 days ) since the "Science" paper was published.

TGOP

 

[twopenneth]

Is there a time frame given for when the papers will be published? In the UK there are Medical Research Council files on ME/ held secret until 2071. I hope the UKs special relationship does stretch so far that America replicates these cover up tactics. Is there a freedom of information? Human rights freedom of expression angle to accessing these papers!

 

[bullybeef]

It is unsurprising that contaminated blood is what driving the FDA/NIH study, whereas the CDC have more reasons not to find XMRV, than they have to prove it.

 

[Trooper]

<snip>

No but seriously they do need to get things in order before releasing information into the public sphere where it will be picked up by the media. Because once it's out there, there is no taking it back. And it's going to get a little crazy.

</snip>

:Retro smile: I like this, thanks George.