Mikovits interview states the FDA will confirm WPI findings in a Sept publication

Stone

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PNAS 'sneak peek'?

I seem to remember that last Monday, someone was able to check on a website that lists a brief description of what was expected in the following day's PNAS publication. Has anyone checked this today? Did I miss that?
 

urbantravels

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I think you're thinking of the PNAS website's own "Early Edition" where they normally post online versions every day of the articles that will be in the forthcoming weekly print edition. There is no advance "table of contents" or anything like that available elsewhere.

Speculation at this point is that this article is going to go online on the same date as print publication, which would be a Tuesday. They normally seem to update the site around 3 pm Eastern/noon on the West Coast, but I've seen it happen later than that. Yes, I am stalking PNAS, and I'm not the only one!
 

Rrrr

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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 FDAs 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Mikovits said they also have new, unpublished data concerning the retrovirus, XMRV, that could lead to treatment of Chronic Fatigue Syndrome.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 peoples immune systems go back to normal. Thats the latest data thats really amazing. Thats what were 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 universitys 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 its a retrovirus. So theres 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 thats what this new facility is for.
 

Rrrr

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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.”
 

Stone

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I'm glad you are stalking, somebody has to. I wish it came out earlier in the day since as my luck would have it, I have to be away from my computer at the time PNAS comes out tomorrow and I won't be back till late. I can't possibly overstate how much I hope "The Paper" is published tomorrow, and along with that, how much I hope it's not another disappointment to a battle weary community. Sleep well friends.
 

urbantravels

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Hmmm...God love 'em but newspaper journalists do often get things wrong. Ever been involved in real life with something that gets written up in the paper?

What the heck does "the FDA's review of their findings" mean, anyway? That would not be an accurate description of the Alter paper.
 

Stone

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Oy, from what I just read that was posted above, it looks like September. <heavy sigh> Just like always, time will tell. You would think that after all the patience I've had to muster for so many years that it would be second nature by now, but it's not. Well, we do what we must, just as we have always done. It will be worth the wait if it's as positive as stated above, well worth the wait.
 

thegodofpleasure

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XMRV is causative ?

We have immune system profiles and we can tell by the immune system how the XMRV is doing the damage,

This statement is highly significant

I look forward to seeing the supporting evidence (not to say that I have any doubt about what she is saying)
 

dannybex

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ditto...

“We have immune system profiles and we can tell by the immune system how the XMRV is doing the damage,”

This statement is highly significant

I look forward to seeing the supporting evidence (not to say that I have any doubt about what she is saying)
Yes, it will be interesting to find out what she means...does it affect NK cells, does it cause the shift from th1 to th2, etc..

It will also be interesting to see how or if they will be able to say it's XMRV that is 'doing' ALL 'the damage', or if other factors (as Katz and others have suggested) may be involved.

Of course for those who test negative, there will be other factors. Nevertheless, regardless of whether one is XMRV+ or negative, this is great news for CFS/ME patients.

I predict this thread will be 20 pages long within 24 hours.
:Retro smile:
 

Cort

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I honestly don't think there's any doubt that its going be positive. I think we should count our chickens before they hatch. Annette Whittemore basically said positive studies are on their way out, Katz said he expected the study to be positive....there's just too much good news breaking...its in the air the air I think.

Whether Dr. Mikovits should be 'breaking the story' to the media several weeks before the paper is published - if is indeed going to be published in Sept. I don't know.
 

LJS

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Whether Dr. Mikovits should be 'breaking the story' to the media several weeks before the paper is published - if is indeed going to be published in Sept. I don't know.
I completely agree, WPI's PR skills are a disaster. Dr. Mikovits should not be saying anything about unpublished data, period. This is how you get a bad name in the scientific community and it will certainly not help get funding for future studies form the government or other research organizations.
 

alex3619

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Hi thegodofpleasure

I couldn't agree more. I have just been discussing this kind of thing on another thread, and I have now posted a link to this one. We can't ensure good treatment if we can't measure progress. This might the the third game changer from the WPI! (Discovery, diagnostic test, monitoring progress... what next?)

Bye
Alex
“We have immune system profiles and we can tell by the immune system how the XMRV is doing the damage,”

This statement is highly significant

I look forward to seeing the supporting evidence (not to say that I have any doubt about what she is saying)
 

Kati

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IT's easy to judge when one doesn't have all the facts. Maybe she asked Alter what was ok to say or what was not ok to say. These people aren't kids and know more than you think about what should be said...

To say that the WPI PR skills are a disaster- is rude and annoying. I wonder if LJS will celebrate the opening of the WPI and get the hell out of a terrible disease or that comment will go on and on and on about what's negative about WPI.

Can we, just for this week, celebrate good things? And be positive?
 

Cort

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I completely agree, WPI's PR skills are a disaster. Dr. Mikovits should not be saying anything about unpublished data, period. This is how you get a bad name in the scientific community and it will certainly not help get funding for future studies form the government or other research organizations.
Yes, lets just this out of our (my system) - what was she thinking breaking another colleagues findings two weeks before they were published? Annette was able to sit on Nevada Newsmakers and simply state positive replication studies will be coming - which was fine. Then she scooped herself on a unpublished study that she hopes will come out by XMAS. :) :) It would have been so much cleaner if the paper had gone the course. Maybe it wouldn't have made it anyway. In two weeks time it probably would have been an open secret. It'll be interesting to see if everyone just opens up about it now that the cat is out of the bag.

On the other hand its true - this is the big news. This is where the tide should turn. I can't imagine she would say anything without being absolutely sure it was true. And it's not only one positive study but others are on the way as well. I can see oodles of dollars pouring into XMRV and ME/CFS. This is what I put on the XMRV Buzz page.

Dr. Mikovits broke whatever embargo was present on the Alter paper, stating in an interview with RGJ.Com, what has seemed to be more and more obvious - that the Alter paper is going to confirm the WPI's findings when it is released. While no one yet had directly said so, the news seemed to be in the air. In an interview in Nevada Newsmaker Annette Whittemore very confidently said several new replication studies will shortly out confirm the WPI's findings and the mood overall seemed very good.

It's a big day, a huge day for CFS and, of course the WPI. How fitting that the WPI which has endured six months of skepticism as study after study has failed to find XMRV not only in ME/CFS but in other diseases, was greeted with this news as they cut the ribbons on the new facility. Representatives of drug companies and diagnostic laboratories are reportedly among those attending the WPI's Symposium this week.

There was already good news on the treatment front with Andrea Whittemore, who became severely ill after having to go off Ampligen, as she reported that she had improved significantly on new treatments linked to XMRV. With the confirmation of XMRV in CFS the drug companies appear to be picking up track right where they left off six months ago when the negative studies appeared. Dr. Lombardi stated that treatment trials could begin at the WPI soon. Annette reported that the the WPI is putting together a team of physicians to lead the medical end of the WPI as fast they can and hope to open in late Fall.

Dr. Mikovits also scooped herself on a paper she expected to published at the end of this year that she reported will demonstrate distinct immune abnormalities are present in ME/CFS patients infected with XMRV. This is a major accomplishment because it suggests that XMRV is more than a 'passenger virus' but may have profound effects on the immune system. With researchers able to show XMRV is causing distinct immune abnormalities the next step is to show that drugs that remove the virus and recorrect the immune system abnormalities lead to improved health. Three drugs have been able to stop XMRV in the lab and Dr. Lombardi felt many more were potential candidates stating there was alot of 'low-hanging fruit' available on drug company shelves.
 

Cort

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Oy, from what I just read that was posted above, it looks like September. <heavy sigh> Just like always, time will tell. You would think that after all the patience I've had to muster for so many years that it would be second nature by now, but it's not. Well, we do what we must, just as we have always done. It will be worth the wait if it's as positive as stated above, well worth the wait.
Its like we've been teased to death by this virus and this is the final tease.....
 
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Mikovits did not break the results, others have already done that. There's already been a scientist in the UK saying results will be out in September, and plenty of US scientist have said the study will confirm the finding and more.

It's not new news at all