FDA/NIH XMRV paper ON HOLD

[redo]

If Harvey J. Alter wanted to get his study published, but knew the DHHS would say "no!", then a small leak would do the trick.

He has been involved in major breakthroughs in the past, and I guess he knows the process better than most.

I'd give it some 20-30% chance that the leak was done on purpose. The pdf he used is still up on the dutch website for everyone to see.

 

[Athene]

Just a thought

The association of XMRV and CFS is all over the NIH website and stated categorically as fact.
http://www.nih.gov/researchmatters/october2009/10192009cfs.htm

If the latest study by NIH and FDA has been a joint effort and produced another positive result, this is basically a reiteration of what is already out there in the public domain.

So, if pressure is now being put on the various government agencies to "reach consensus before publication", isn't it more likely that the CDC is being pressured to explain why it cannot replicate the results of the NIH & FDA?
Otherwise the NIH would have to withdraw /recant on an already published conclusion.

Or am I just being too optimistic and naive?

And BTW do we know if they were using the same patient cohort/batch of blood samples? Is this difference likely to be a question of patient selection, or methods for finding the virus?

 

[redo]

"And BTW do we know if they were using the same patient cohort/batch of blood samples?"
It wouldn't surprise me if they were swapping batches now, and testing each others batches.

 

[VillageLife]

Right now I feel so up set!

 

[natasa778]

doesn't this bring us to the "CDC delays publication of XMRV paper in order to prepare a press release" issue...?

I like what Athene said :Retro smile:

 

[Otis]

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

I love this idea!

 

[Sasha]

I've been struggling to decide what I think about this. Certainly, holding independent studies back from publication when publication has already been agreed just because they have conflicting results is weird. It's not the normal scientific process in which good quality science gets published and then everyone thrashes out why results differ.

The public health people holding these studies back must realise that the Alter study can't be the one in error, because you can't get a false association between XMRV and CFS unless you have a problem with blinding in the study (in which case it couldn't have got past the journal's referees). Blinding was being cited as an issue in the Lombardi paper so there's no way a govt-funded follow-up study could be done without that being nailed down at the design stage.

It can only mean that they know the CDC study is a false negative. They must realise that the XMRV/CFS cat is already out of the bag, with the international research community all over this and Alter not silenceable. Heavyweights like John Coffin are aware of the situation and would no doubt speak out if positive findings were supressed at this point.

I see this as the US govt realising that the Alter study is conclusive and not wanting the CDC publishing something that will undermine that study or confuse the public. I think it would have made more sense to have put the CDC study only on hold; but (giving the benefit of the doubt) they might have thought that that would have looked like selective supression of results and that that would indirectly have undermined the Alter study.

I agree with George and others: it's frustrating but I think the US govt understands the evidence is there now for an XMRV/CFS link, knows XMRV is prevalent in the blood supply and wants its ducks in a row before publication. I'd expect fast-track publication and press releases once the issues are resolved and I'd expect enormous pressure on the CDC to get those issues resolved fast.

I also believe that the XMRV train is well underway now and couldn't be stopped by any govt, even if that was their intention.

 

[Sasha]

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

Yes, I love this idea too!

 

[Esther12]

I wonder if it is because the psychological CFS researchers have told them that releasing a positive study will make CFS patients more seriously disturbed and resistant to treatment?

I would love to have full access to the discussions that have surrounded this decision.

Looks pretty good for XMRV/CFS though. I would be much happier if we had access to the papers and could examine them all publicly though. This lack of information is killing me.

ps: CFS is always treated unusually - I've just come to accept that now.

 

[bullybeef]

Great point Sasha,

If there weren't three federal bodies involved, the studies would have been published as normal. I understand that the CDC study was done months ago, before the PCR method was questioned. But, if this is the case, how did it pass a peer review, and whom reviewed it?

 

[Sing]

Yes, I thought the CDC were being too quick to come out with a study before testing methods were clarified and the patient cohort strictly defined. I bet that tis the core problem with the different results: testing methods and patients selected.

I applaud Parvofighter's posts (#37 and 38) and wish he were in charge himself and bringing order to the confusion.

As for Dr. Yes's suggestion here (#40): "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."

Can someone identify people/addresses to write to?

Thanks!

 

[VillageLife]

I just feel if they keep us holding on to long it will start to do more harm then good.

Tensions are rising.....

 

[Forbin]

I would have to imagine that "senior public health officials" might have a vested interest in the CDC appearing to remain infallible. It is the agency that the public seems to rely on during flu epidemics, etc... I don't think people really think about the NIH in that way. Apparently, the CDC has quite a PR machine.

 

[Sasha]

Great point Sasha,

If there weren't three federal bodies involved, the studies would have been published as normal. I understand that the CDC study was done months ago, before the PCR method was questioned. But, if this is the case, how did it pass a peer review, and whom reviewed it?

Hi Bullybeef - my understanding is that it's only at this stage with a positive replication that it will be becoming clear how to detect XMRV reliably. Even the original Lombardi study (I think) picked up some XMRV using PCR (but most of it using a combo of methods including culture).

The paper will have been peer-reviewed probably a month or two ago and the reviewers will have done their best with the knowledge available at the time.

I wouldn't expect ever to know who reviewed it; peer review is normally anonymous to avoid come-back from angry authors whose papers are rejected.

 

[floydguy]

There could be a concern with the CDC's credibility. If they botched something that could be at the center of a firestorm then they will have major egg on their face. Less credibility means fewer people paying attention to what the CDC says and fewer people taking vaccinations and obeying advisories from the government on infectious diseases. I am starting to see the potential of the CDC being lampooned on Saturday Night Live...

 

[Otis]

Tick Tock

The ME/CFS clock marches onward. People are getting sick(er).and treatments are delayed. Prevention is on hold. The band plays on.

The real credibility hit is to papers still in work which can more easily and quietly buried or "influenced".

The stakes are high. I mentioned a week ago that we were on the cusp of a tipping point where we get one chance to help things fall in the right direction. We've reached it folks. It's time to let all our "leaders" and press contacts know we can't allow the science to be stopped. If that happens, we lose.

"Tick tock people, time is slipping away." - Stevie Ray Vaughn

 

[Stone]

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?

Someone please straighten me out on this if I'm mistaken, but if I remember correctly (and I frequently don't), I believe that at the last CFSAC meeting (travesty that it was in large part), we were all on the edges of our seats waiting to hear what the new doc who is now temporarily in charge of the CFS research was going to say. It turned out that she was planted firmly atop the old pile of crap the CDC has been calling 'research', and still not getting that the CDC isn't getting anywhere with their 'research' because they still can't distinguish between CFS and depression or chronic fatigue or chronic unwellness (WTF that is). It appears to me that the CDC wouldn't recognize a true case of CFS if it fell on them, and that's one possible reason that they can't find XMRV even if they're using the right protocol in the lab. A TEST IS ONLY AS ACCURATE AS THE INTEGRITY OF THE SPECIMEN, and if you collect your specimens from the wrong cohort, as the CDC is famous for doing, your research is flawed from the gate. It's like studying diabetic neuropathy among people who are just thirsty a lot. How accurate will your study be? Of course your results are going to differ from another lab who is studying diabetic neuropathy in say, um, diabetics perhaps. Just a thought.

 

[Sean]

I also believe that the XMRV train is well underway now and couldn't be stopped by any govt, even if that was their intention.

Agree with that.

I don't see any incompetence or conspiracy in this hold up, there is nothing to be outraged about here. This is just the government health authorities quite rightly wanting to get things sorted before making what looks like being a major public health announcement.

 

[Sean]

I wonder if it is because the psychological CFS researchers have told them that releasing a positive study will make CFS patients more seriously disturbed and resistant to treatment?

Somehow I don't think that line is working too well for them anymore.

There is no way the virologists (or any other medical scientists) are going to agree to burying their own positive studies, on that flimsy basis.

Besides, there is already too much attention to this issue in the media and online, they couldn't bury it now if their lives depended on it.

 

[Megan]

Another article from Science magazine saying the same things but a bit more negative:

http://news.sciencemag.org/scienceinsider/2010/06/conflicting-papers-on-hold-as-xm.html.

But good to see it is getting picked up. I would have thought Science magazine would have been more critical about witholding of the paper.