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

[Cort]

Cort and Mark,

You are manufacturing controversy where none exists.

It has been known since the end of May that Alter had positive results that confirm the WPI findings. The only way for this result to have changed in the meantime would have been from political interference.

Dr. Mikovitz did not say anything that was not known and did not reveal the specific results of the study.

Here's the title of the article

"Findings by Reno scientists confirmed by U.S. government"


I sure didn't know it. Did you really know that the paper was going to end up positive? Is that why we are checking PNAS every day?

I think the paper chose to do an article on the story because it was news. We knew the Alter paper was positive but we also knew that he had gone back to do further testing and we didn't know what the results of that was. The further testing could have revealed he was wrong.... but it did not.

I don't know where I got that 'two weeks' from.....sure it could be six weeks

In any case the really important news is that the XMRV finding has been replicated! Not just in one study but apparently several. It took 8 months and studies or so but now several independent laboratories have finally confirmed the WPI's findings. I think that's an amazing thing after all the controversy and all the negative findings. Its kind of amazing.

It wasn't just the CDC and Kuppeveld etc. Abbott apparently stopped their study in Spain because it wasn't getting positive results. There was the antibody test that found XMRV in .5% of a 1000 or so healthy controls. The CDC couldn't even find it in positive samples. Whatever you want to think about the CDC they are not going to be happy about being on the wrong side of history - they would prefer to be on the right side of it and they clearly thought they were. This thing has turned around! The WPI was right - all that was needed, apparently, were some true replication studies.

Now the WPI are starting up right where they left off - a drug trial is apparently in the works. One of the most interesting things for me will be how much it shows up in other NEIDS - FM, autism, IBS, etc and then where it shows up elsewhere. I think it would be immensely satisfying and intriguing if it showed up in all these controversial and related disorders but not in other disorders. The next big step is showing that it is more or less unique to CFS and its related disorders. That will be an absolutely key step. They've shown its not in healthy controls as much - that's very important. Now - is it causing a pattern of disorders? I suspect that it will.

The fact that it is so much more prevalent in CFS than in controls is obviously very important. The fact that its much more prevalent in CFS patients than any other pathogen suggests that it does play a major role. Annette said none of the other pathogens in CFS are associated with more than 10% of CFS patients yet here XMRV is in about 70 or 80% (according to Mike Hillerby). That combined with the findings of immune abnormalities reported by Dr. Mikovits (again prematurely ) suggests that it really is acting like an AIDS like virus - that it is disturbing the immune system - allowing other pathogens to enter. For some reason they seem to be mostly herpesviruses and figuring out why that is will be fascinating.....

 

[SickOfSickness]

I don't have energy to keep up with it all, but at least things are continuing to happen. Things that could be good...

 

[rebecca1995]

...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.

Dr. Mikovits did not "break" this story. The story broke on 6/22/10 when the Dutch magazine Ortho quoted Dr. Alter's May slide presentation, which was publicly viewable. Since then, additional details have been reported by journalists Hillary Johnson and Mindy Kitei.

I sincerely hope that when the PNAS paper is finally published, actual science will eclipse unjustified sniping at the WPI and Dr. Mikovits.

 

[grant107]

This is great news. I feel progress is finally being made.

 

[Megan]

Much Ado About Nothing

I have looked up something I remember seeing earlier about PNAS's policy on prior release of information. Both of these articles are old but I can't find anything later from PNAS. On my reading of both of the attached articles, neither Judy Mikovits's article, or the earlier release of information breaches the prior publication policy of PNAS.

http://www.pnas.org/content/100/14/8039.full?sid=f2a00f5e-b038-4f02-ae15-f34f67f11ae4

http://www.pnas.org/content/96/8/4215.full?sid=86051c77-7ca0-4abe-a488-725987fdf158

A quote from the first PNAS editorial:

Should a webcast scientific talk be viewed as a publication? In an April 1999 policy statement by the PNAS Editorial Board on Prior Publication of Papers, we wrote that results “have already been published if they have appeared in sufficient detail to allow replication, are publicly accessible with a fixed content, and have been validated by review.” A seminar archived on the web fails to meet the first and third of these three standards and thus does not prejudice subsequent publication in PNAS. The editorial continues, “Our guiding principle is that journals should interfere minimally in such exchanges [before formal publication]; authors themselves should dictate the dissemination of their own work.”

I just double checked the Zagreb conference site and Alter's slides are still sitting there. Presumably they would have been taken down if some sort of pre publication ban was on them?

http://www.sanquin.nl/ipfa/Upcoming...nsf/v-HomePage/$first!OpenDocument&AutoFramed

Go Judy!!!

 

[Cort]

Dr. Mikovits did not "break" this story. The story broke on 6/22/10 when the Dutch magazine Ortho quoted Dr. Alter's May slide presentation, which was publicly viewable. Since then, additional details have been reported by journalists Hillary Johnson and Mindy Kitei.

I sincerely hope that when the PNAS paper is finally published, actual science will eclipse unjustified sniping at the WPI and Dr. Mikovits.

There have been two stories 'broken'. First the original results of the Alter paper. Then the results of Dr. Alter's findings after he went back and did new testing. I think everybody was on tippytoes wondering what would happen when Alter went back and did new testing. Now we know.

You're right it's too bad that this thread is being taken up by this controversy. When the paper is actually published we'll be able to concentrate strictly on the science.

 

[Cort]

I have looked up something I remember seeing earlier about PNAS's policy on prior release of information. Both of these articles are old but I can't find anything later from PNAS. On my reading of both of the attached articles, neither Judy Mikovits's article, or the earlier release of information breaches the prior publication policy of PNAS.

http://www.pnas.org/content/100/14/8039.full?sid=f2a00f5e-b038-4f02-ae15-f34f67f11ae4

http://www.pnas.org/content/96/8/4215.full?sid=86051c77-7ca0-4abe-a488-725987fdf158

A quote from the first PNAS editorial:



I just double checked the Zagreb conference site and Alter's slides are still sitting there. Presumably they would have been taken down if some sort of pre publication ban was on them?

http://www.sanquin.nl/ipfa/Upcoming_Events.nsf/Web%20Body?OpenFrameSet&Frame=Body&Src=%2Fipfa%2FUpcoming_Events.nsf%2Fv-HomePage%2F%24first!OpenDocument%26AutoFramed

Go Judy!!!

I really hate to keep up on this because I don't think that this issue is the big news but again, we are not talking about the results of Dr. Alter's original study - we are talking about the results of Dr. Alter's (altered study. The results could have completely changed - that's why the DHHS asked him to do new testing - that's why we have been checking PNAS so frequently. Nobody knew what the ultimate results of the new study would be. ( I think I've had my say on this...that's enough for me )

 

[Megan]

A further quote from the above PNAS article (the second one):

PNAS policy is that a summary of work in a review, a perspective, a commentary, a newspaper or magazine article, or wherever does not constitute prior publication. .......

All investigators should strive to inform the public about the accomplishments, methods, and motivations of science. This is best done in the popular press.

 

[Cort]

In any case to the future.

The CDC has becoming more radicalized in the last six months. They've stated they believe some of the people in original Science study did not have CFS. They are on the edge of stating that people with herpesvirus infections do not have CFS. They are pursuing the childhood abuse scenario more and more. They are more and more allied with the idea that pathogens are not at play in CFS. They've basically backed themselves into a corner and then this hits.

The Alter paper itself will need to be replicated but it appears that it may have already been so and future studies need to prove that XMRV is a major factor in CFS but an retrovirus sitting in 70% of CFS patients and just a few healthy controls is an astounding fact. Just on the face of it it would appear that XMRV is a major factor in CFS.

Could we see, over time, massive changes in the personnel and direction of the CDC program? They have never been confronted with such a blatant contradiction of the focus of their program. Honestly, I think its going to be too much. I see, over time, big changes there.

 

[Megan]

I really hate to keep up on this because I don't think that this issue is the big news but again, we are not talking about the results of Dr. Alter's original study - we are talking about the results of Dr. Alter's (altered study. The results could have completely changed - that's why the DHHS asked him to do new testing - that's why we have been checking PNAS so frequently. Nobody knew what the ultimate results of the new study would be. ( I think I've had my say on this...that's enough for me )

Cort, I am trying to diffuse the 'controversy'. It seems to me that us patients may have been misinterpreting much of this pre publication business all along and being a bit too black and white about it. If the above details of the PNAS editorial policy are correct, then this would apply equally to any new findings or results the study may have.

 

[Cort]

A further quote from the above PNAS article (the second one):

That is very interesting! PNAS does have a very liberal prepublication policy. Investigators are allowed to prepublish summaries of their work in magazines, etc. Of course these summaries will include the findings of the paper - so it would be fine if Dr. Alter, for instance, gave a report on his findings to another journal. Good catch!

They don't say anything about someone other than the author reporting on the findings to the media or another journal. I would think that etiquette would suggest that Dr. Alter make that decision but its clear that he has their blessing if he wants to spread the word. Its not nearly as restrictive as I imagined it to be.

It seems there's considerable leeway amongst journals in how far they will allow their authors to go.

 

[Recovery Soon]

Does she mean she can correct the immune system for good and we are cured?????????

Great Question. THOUGHTS?

 

[Cort]

Cort, I am trying to diffuse the 'controversy'. It seems to me that us patients may have been misinterpreting much of this pre publication business all along and being a bit too black and white about it. If the above details of the PNAS editorial policy are correct, then this would apply equally to any new findings or results the study may have.

I agree that we've apparently been too black and white about it. We've kind of assumed that there is a strict embargo policy for all journals. That kind of got smashed in our face when the CAA was taken to task in October simply for stating that a paper was going to come out in Science in two days. That set the tone for me but it sounds like some medical journals are starting to reform a policy that drives so many people crazy. Whether Dr. Mikovits should have taken it upon herself to break Dr. Alter's findings is another question; I would still suggest that that was a mistake but the embargo policy by PNAS is very liberal, for sure.

 

[Cort]

Great Question. THOUGHTS?

Actually I would think it would be the opposite - remove the virus and the immune system repairs itself. That is what happens, I believe, with AIDS. It'll also be very interesting to, at some point, learn what Andrea is taking that has helped her so much. I was told that she was having alot of seizures - obviously a quite dangerous situation. I wonder if she's taking something other than the standard antiretrovirals? I kind of got that sense from the way she was talking.

 

[Megan]

Cort, I just hope those PNAS articles are still correct.

I was not trying to have a go at you, am actually quite a fan even though I have often countered you. I tend not to post so much when I agree with something.:Retro smile:

 

[Daffodil]

i also wonder what andrea is taking. maybe she is still on ampligen? its sad the virus has hit her so hard that she has seizures. the tahoe group got the worse strain.

it's interesting that andrea still seems to be quite tall, despite being infected at age 12. ...dont know why i noticed that lol

-S

 

[muffin]

Quite truthfully, at this point I just don't give a damn about protocol and what Dr. Mikovits said. All I care about is getting the XMRM nailed, out to the public/researchers/policy makers, getting far more research and a CURE. I want a CURE. If Mikovits made statements about other studies I expect that was quite fine with the other authors.

Let's keep our eye on the ball: We need XMRV to be a very strong correlation to ME/CFS and more research to get that cure. Apparently, according to several interviews with Mikovtis and others, they do have more research going on than just the XMRV correlation. (See below in bold)

I think someone already posted but this statement pleased me to no end. Also, please donate to http://www.causes.com/causes/511536 so that WE can hit the Washington Post at around the time that this study comes out to get the biggest bang and really inform millions and millions of people in the US and worldwide. Remember, we need funding for reseearch and that means ensuring that those critical people in Washington DC KNOW about this virus and all of its possible implications. Don't expect the CDC to do a thing about this other than try to kill it off and keep it away from the public. WE MUST BE THE ONES TO SPREAD THE WORD ON XMRV AND CFS/ME!!!!!

http://www.rgj.com/article/20100816/NEWS/100816069/1321#pluckcomments “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.”

 

[Megan]

They are on the edge of stating that people with herpesvirus infections do not have CFS.

Cort, what do you mean by this? I thought no one agreed we had herpes viruses anyway? Do you mean the type of people the Stanford group have been treating, ie those with high viral titers for HHV6 and EBV? Or post EBV CFS cases?

The Alter paper itself will need to be replicated but it appears that it may have already been so.

Also where is this from? I didn't get this from Judy's article?


BTW, the thing that bothered me about Judy's article is that the Alter paper sounds like its not coming out until September. If that's the case I hope it doesn't slow things down for the XMRV conference. My biggest concern as a patient is that the science on this is not slowed down in any way.

 

[muffin]

I really do not understand how this thread turned into a major fight. Come on guys, knock it off. Be happy that PNAS is going to publish and that the word on the street is that the study will be even stronger than what WPI found. Remember, fighting amonst ourselves helps the "other side" do a "divide and conquer" and we certainly can not have that. NOT at this critical juncture.

Let's be happy that the PNAS study will be a strong positive - or that's what I think I'm hearing from Mikovits and WPI. That's what's most important.

 

[rebecca1995]

...You're right it's too bad that this thread is being taken up by this controversy. When the paper is actually published we'll be able to concentrate strictly on the science.

What controversy? The only controversy I'm aware of is that the negative paper, by the CDC, was published 7/1 while the positive paper, by the NIH/FDA, is being held from publication for more than two months. That's the violation of scientific protocol that we should focus on. It seems to me you're going to great lengths to find fault with Dr. Mikovits, when, as Megan pointed out, no breach of PNAS guidelines has occurred.

This is a triumphant week for the WPI and Dr. Mikovits--and personal attacks aimed at her cannot diminish that.