Suspense. Any news on WHEN the NIH/FDA study might come out?

I sent an email to Dr. Francis Collins (head of NIH) several weeks ago, and got a reply (this week) from the Office of Research on Women's Health. The main paragraph reads,


"You expressed concern with the delay in publication of the paper written by Dr. Shyh-Ching Lo of the Food and Drug Administration, Dr. Harvey Alter of NIH, and their coworkers, about their studies on the Xenotropic Murine Leukemia Virus-Related Virus (XMRV). As typically occurs in the process of publishing scientific findings, the authors are presently addressing issues raised during the peer review of the manuscript and expect publication soon."


I hadn't mentioned Dr. Lo in my letter, but this reply confirms that he's a co-author, at least. The reply didn't really answer my questions or concerns (I wasn't really expecting that anyway), but at least it does give a bit of information. I'm not sure what "soon" means to a scientist, but I hope it means "a few weeks" and not months. But if the authors are still addressing peer review issues as of this week (assuming the reply had the latest information) would publication in August still be possible? I suppose it would depend on the extent of the latest peer review issues and how many changes are made in the revised manuscript.

It also suggests that someone is not being honest about what stage this paper is at.

In my experience, which is not recent, "soon" is likely to be a few weeks. :Retro smile:

I'm guessing Dr Collins was not speaking with great precision here. The authors could be reviewing the new galleys based on the changes made during the second peer review. If so, publication could be very soon. If they're still working on rewriting the paper after the second review, we're looking at more than a month, I'd guess.

If (Please, no!) the paper has been sent out to reviewers again and more suggestions for improvement have been made, then it may be months. Let's not forget that the Science paper was in review for 6 months. However, that doesn't sound likely if Dr Collins {correction} says publication will be "soon".

My money is still on mid- to late-Aug and I won't be surprised (impatient, but not surprised) if it's not out until mid-Sep. If it's not out by late Sep, then I'm going to start pacing the floor.

Edit: Sorry folks, I had a brain slip or something and typed Coffin when I meant Collins. Sorry for any confusion. Thanks to Rrr for catching it.

Anyone know anything more about FDA/NIH paper timing? Tomorrow is a Tuesday.......the first in August...PNAS comes out on Monday nights.....

Not heard anything,

where did you hear that doctor coffin says the publication will be soon??????

How often is PNAS published? Monthly? Quarterly? Whenever they feel like it?

Weekly. Tuesdays.

Sorry, my bad. I meant Collins. I corrected it. Sorry for the confusion.

Ahhhh, thanks so much. I've been trying to figure that out for a while now.

It's not in this week's print edition, anyway - the TOC just went online a little while ago. Frog on the cover.

Frog on the cover! -hmmmm we will be needing a mouse on the cover! lol

How about a stock photo of a sleepy person? Those seem to be popular.

Off topic, but hilarious combination of stock photo and caption:

http://www.metro.co.uk/news/835511-flying-ants-plague-london

I guess they couldn't find a picture of an actual flying ant, so...creative captioning solves the problem!

A researcher here in the UK contacted PNAS to ask when THE article will be out and got the reply from the managing editor, Daniel Salsbury, that it is indeed in press and SHOULD appear in press by the end of the month!!!

Here we go again, doesn't know and it will be. Very clear. Does it all tie in with the XMRV conference in September? Can they pushed out the WPI by then?

Thanks Dasimay,

Good to hear that PNAS are saying by the end of the month!! I am assuming that one week will be in time for scientific debate at the XMRV conference? To me that's the most important thing at this point. I wonder if Dr. Alter will get late invitation?

sounds great..but
why would the editor of Pnas say "The Alter paper is now in press, but I don't know when it will go online and until then there will be a press embargo," to Mindy, while telling it will be out end of the month to another "source"?

still hope it's true, though

Exactly. Why two slightly conflicting pieces of information? Is someone telling PNAS when they can publish?

Mikovits interview states that the FDA will confirm WPI findings in a Sept publication. so i guess this means the NIH/FDA paper will come out in Sept?


http://www.rgj.com/article/20100816/NEWS/100816069/1321

Two Reno scientists, who last year discovered a new infectious human retrovirus they linked to Chronic Fatigue Syndrome, said Monday that their findings have been replicated and confirmed by the U.S. Food and Drug Administration.

Dr. Judy Mikovits, one of the lead researchers with the Whittemore Peterson Institute for Neuro-Immune Disease in Reno, said the FDA’s review of their findings is scheduled to be published in September.

“There has been an issue over whether anybody could replicate our study, and it will not only confirm our findings but extend our findings, which is really exciting for us,” she said.

Mikovits said they also have new, unpublished data concerning the retrovirus, XMRV, that could lead to treatment of Chronic Fatigue Syndrome.

“We have immune system profiles and we can tell by the immune system how the XMRV is doing the damage,” she said. “So we could have a diagnostic test to follow clinical treatment and show that people’s immune systems go back to normal. That’s the latest data that’s really amazing. That’s what we’re after.”

That data will be published by the end of the year, probably in a clinical immunology journal, she said.

Lombardi said clinical trials could begin soon at the Whittemore Peterson Institute, which is relocating from its tiny laboratory on the University of Nevada, Reno campus to the university’s newly opened Center for Molecular Medicine.

“Actually, we already have been contacted by people who are sending us tests, perceiving that they may be asked to be part of the clinical trials,” he said.

“I think once the (FDA) paper comes out and once the controversy is put to rest, the pharmaceutical companies will realize that this is some very low-hanging fruit for them to make the next transition,” said Lombardi. “There are so many drugs that have been developed for HIV, and it’s a retrovirus. So there’s probably a ton of HIV drugs that they can go back and re-screen that could be used.”

There also are three published drugs that work against XMRV, Mikovits said.

“We totally expect at least one clinical treatment trial before the end of the year,” she said. “That is our goal and that’s what this new facility is for.”

Yup, unfortunately it is not in this weeks issue: http://www.pnas.org/content/107/33.toc
I am really hoping this comes out before the XMRV conference. Maybe it is being released the day of the conference?