FDA and NIH confirm WPI XMRV findings (report of leaked presentation)

[jimbob]

erv,smerv whatever! hit the road jack and don't come back no more!

 

[Otis]

a friend suggested to me that this news was purposefully leaked by the NIH to the dutch journalists, knowing it would go "viral" online. a trial test balloon, to see how the public reacts. let the news out slowly...?

I think that was postulated earlier, but I read so much about this last night I'm a little fuzzy. It leads me to wonder if there was something of a larger calculated plan.
- First the AABB announcement to take credit for taking a "proactive" step - weren't we smart (NOT).
- Then this leak to spread it as something less than absolute fact to ease folks into this, if indeed it makes mainstream media.
- Finally (?) announce a journal publication, perhaps on a Friday afternoon to further soften the "blow"

The nature of news propagation now is that while things spread quickly across blogs, forums, etc., the same "news" continues to circulate over the course of months. My daily XMRV Google Alert continues to come up with the Science paper hits almost daily along with more current stuff. So while the news cycle is faster it is also more "sustained" over a longer period of time, at least by the second and third tier news sources which just regurgitate "news".

What we really need is good in-depth pieces from the WSG and the NY Times to really lay down all the facts (and of course Hillary) but I suspect we'll have to wait for a more formal announcement before that happens.

 

[Cort]

Dutch XMRV Scoop Reverberates

From my latest blog: http://blog.aboutmecfs.org/?p=1637

Patients leapt for joy at the news suggesting that the WPI’s findings have been validated by two major institutions in the US but not everybody was happy that the information had been released in a way it was. The Whittemore Peterson Institute posted a link to Dr. Raccienllo’s blog but refused to discuss the press release otherwise, citing the need for a prepublication embargo of scientific findings. The CFIDS Association didn’t post a link anywhere as they cited the same need. Both organizations either fund or produce research and need to maintain strict standards regarding scientific mores.


ESME – an Alliance of European professional researchers, felt no such compunctions, immediately sending a link out to all their subscribers and posting the press release on their website. Neither the ME Association nor MERUK nor Invest in ME, however, have reported on it nor does it appear that other news services have. It’s hard to imagine that the ‘scoop’ could imperil publication of an important paper but the episode does underscore the antagonistic relationship between a press that wants to expose everything and a research community for whom prepublication exposure can have dire consequences. Did the Dutch Journalists do us a favor?


Red Cross Report At the Zagreb Conference - Meanwhile other reports from the Zagreb Conference popped up. Roger Dodd, an official at the American Red Cross also gave a lecture on XMRV there in late May. Some of his points could presage a shift that may occur in how CFS is viewed in the future. For instance, after noting that CFS patients often have an acute infectious onset his outline states that outbreaks in the disease do occur – a well accepted findings amongst patients but something that’s quite controversial in the traditional research circles.


He also provided a list of infections that are putatively associated with CFS. What was impressive about Dr. Dodd’s list was it’s size; it contained enteroviruses, Epstein-Barr virus, cytomegalovirus, HHV-6 and 7, B-19 parvovirus, hepatitis C virus, HTLV (DeFrietas), spumavirus, Chlamydia pneumoniae, Coxiella Burnetti, Brucella and Toxoplasma.


He also several times noted the involvement of CFS support groups and the effects of patient advocacy going so far as to highlight a plea from what appears to be a person with CFS that people with CFS be banned from giving blood in the US.


Dr. Dodd’s assessment of the different possible outcomes for XMRV ranged from it being irrelevant (due to it being a contaminant) to a ‘Doomsday’scenario, at least from the aspect of the Red Cross. In the Doomsday scenario, researchers find that the virus


does indeed cause dread diseases such as CFS and cancer
that it has an extended incubation period; - this presumably refers to its ability, like HIV, to apparently be present for a long period of time before its effects are seen, making it difficult to easily spot an infected person and stop the transmission
that it spreads rapidly
that it’s, in fact, already present in much of the population


In the Doomsday scenario the cat is either already out of the bag or very difficult to keep in the bag because the virus spreads so easily and usually undetectably. (Dr. Vernon has brought up the possibility that everyone is already infected but that it only shows up in the blood of certain groups of people. This could make sense given reports of how much tougher the virus is than HIV.) From an official standpoint this would make the virus difficult to control.


He then noted that the Red Cross still needs much information; in particular, a Gold Standard test that can reliably detect XMRV and information on rates of prevalence in its donor population and determining what its risk factors are (i.e. is it just found in CFS patients or people with other diseases, or healthy controls?).


The Blood Study : Then Dr. Dodd provides some information on the National Heart Lung And Blood Institute (NHLBI) XMRV study . The study is using whole blood and plasma to look for XMRV in 400 samples from Reno (BSRI?) and 25 positive samples from the WPI and 25 controls. They are validating their PCR results using antibody tests.


Was the Past Prologue?- If this report proves true one can look back in hindsight and see evidence that it was on its way given a uptick of positive reports over the last month. Several weeks ago Dr. Klimas reported a positive paper was on the way; a finding a Phoenix Rising Forum member reported was originally from Dr. Suzanne Vernon. Today, Hillary Johnson reported in a blog that two researchers have contacted her in the last few weeks stating that a major research paper confirming the Science paper will be published shortly and that it could push positivity rates in ME/CFS even higher.


It’s possible that the recent AABB announcement recommending that blood collection groups aggressively discourage blood donation by CFS patients, was prompted by these findings as well. Before the Fat Lady sings, however, about the association between XMRV and CFS, we need to see that research in print.

 

[CBS]

The Blood Study : Then Dr. Dodd provides some information on the National Heart Lung And Blood Institute (NHLBI) XMRV study . The study is using whole blood and plasma to look for XMRV in 400 samples from Reno (BSRI?) and 25 positive samples from the WPI and 25 controls. They are validating their PCR results using antibody tests.

Cort, Could BSRI stand for Blood Systems Research Institute? The BSRI offices seem to be located in several cities (http://www.bsrisf.org/).

 

[JAS]

I just feel that this can no longer be hushed up anymore, it is true, it is real and it is out there. The roll it plays has yet to be determined but hands are being forced, can the NIH and FDA now deny this? Interesting but I for one feel a huge sense or relief today...hur...bl**dy...ray!! x

 

[Mark]

Denial+Delusions = CBT

Intelligence + Trust + Respect + Communication ---> Truth

 

[taniaaust1]

I cant sleep. up all night reading throu this and thinking.. i dont want to miss anything lol

 

[Wayne]

I really liked this blog and thought I'd share it.

Here's the copy and paste:

June 23, 2010 by cfssufferer

Some days remain etched in our memories for a lifetime. Today is one of those days.
On October the 9th 2009, a small laboratory called the Whittemore Peterson Institute (WPI) made big news by announcing the presence of an infectious retrovirus, XMRV, in Chronic Fatigue Syndrome patients. They found XMRV in 67% of CFS patients (later on in > 95% of CFS patients.) This was opposed to just 3.7% of healthy controls being infected with XMRV. Since October the 9th 2009, the CFS community has waited for a day like today.

The FDA/NIH confirmation
Two Dutch journalists from the magazine ORTHO obtained a lecture given by the National Institute of Healths Dr Harvey Alter. Dr Alter gave this lecture at a Blood Transfusion Workshop held in Zagreb on May the 26th and 27th 2010. As part of the lecture document obtained by the Dutch journalists, Dr Alter allegedly claims that his institute, the National Institute of Health (NIH) and the Food and Drug Administration (FDA) independently confirmed the Mikovits-Lomardi study headed by the WPI. Dr Alters lecture also allegedly estimated XMRV and other Murine Leukemia viruses to be within the donor supply at between 3% and 7%. The original press release can be found here: http://www.mmdnewswire.com/xmrv-9040.html

The consequences
After 9 months of failed validation studies (performed using flawed methodologies) the FDA/NIH study, if true, is a hugely significant study with potentially serious worldwide repercussions that are difficult to fathom. Dr Alter reportedly estimates between 3% and 7% of the donor supply to be infected with XMRV and other Murine Leukemia viruses (MLV). Assuming a homogenous distribution worldwide, this translates to between 200 million and 470 million people infected. With potentially this number of people potentially at risk of CFS, fibromyalgia, atypical MS, autism, prostate cancer and possibly a range of other illnesses, a huge amount of fear may be generated. The vast number of people potentially infected means that money will most likely be thrown at XMRV research.

Hindsight
In hindsight, the reported findings of the FDA and NIH fit in neatly with a lot of rumours and actions of late. There have been rumours recently stating that a positive XMRV study was about to be released. Also, the author of Oslers Web, Hillary Johnson, wrote on her website today that in the last few weeks, 2 researcher-scientists have contacted her, advising her that a major XMRV study was to be released confirming the Mikovits-Lombardi paper. Hillary Johnsons views on the reported FDA/NIH study can be found here: http://www.oslersweb.com/ On June the 18th 2010 the American Association of Blood Banks (AABB) issued a press release discouraging those with CFS or those who had recovered from CFS from donating blood. This was 9 months after the original Mikovits-Lombardi paper and despite only negative validation studies being released. In hindsight, the CFS donor deferral ties in neatly with the reported findings of the FDA and NIH. Last week on the CFS central website, it was reported that a government official revealed that a government agency had found XMRV although the CDC hadnt. This can be read here: http://www.cfscentral.com/2010/06/blood-feud-part-2.html

The implications (if the CDC couldnt find XMRV) explain why they have spent such a significant amount of time delaying the release of their study, ie the contradiction of another government agency finding XMRV. It is also infuriating to consider that the CDC were the group that failed to find the Elaine DeFreitas retrovirus all those years ago. I direct this quote originally by John Maynard Keynes towards the CDC, When the facts change, I change my mind. What do you do, sir?

Caution
I am still cautious about the CFS to XMRV link for several reasons. Firstly, despite the leaking of Dr Alters lecture in Zagreb, Id like to see the study itself. The leaking and subsequent comments are very promising but the way science works is on studies being released. Id hate for the study to not be released for whatever reason. Although having said that, Dr Alter has confirmed that a study is soon to be published. Dr Alter also in his lecture praised the Mikovits-Lombardi study saying it was strong and likely true but causality between XMRV and CFS has not yet been proven. This is an important point as correlation doesnt necessary equal causation and more studies are needed to determine this. I am also slightly cautious about another comment from Dr Alter, stating that XMRV and related MLVs are in the donor supply. This probably has to do with the finer details of the FDA/NIH study however the fact that he qualifies XMRV with MLVs raises several questions. Most likely the study, when released will explain the testing methodologies and reveal if XMRV specifically or MLVs in general were tested for.

Conclusion
Today is a historic day for CFS patients, just as October the 9th 2009 was. The CFS community now must wait on the FDA/NIH study being released. Also the actions of the CDC regarding XMRV in general and their study are eagerly awaited. Franz Kafkas words of There is hope, But not for us have long been typical of CFS patients and their plight. Today marks the day that it is appropriate to paraphrase and negate part of Kafkas quote, leaving us with- There is hope for us.

 

[usedtobeperkytina]

I thought of purposeful leak also, but for the purpose of sabotaging publication.

Gosh, I think I have been hanging around some of you guys too long. I don't usually think conspiracy theories.

for a couple of reasons, I don't think this is the case. Number one, reporters didn't get it from NIH, they got it from the conference, no doubt after hearing something important was said there. The researcher refused to comment. It is not unusual for closed door medical conferences to discuss unpublished info. WPI did that before. And just as that closed door meeting didn't lead to news stories at the time, it is understandable they would think they could discuss it in a closed door and it not be in lay media before publication. And maybe he thought it would be published by June 1, just four days later.

Tina

 

[taniaaust1]

i just emailed my CFS specialist about all this.... .. umm i should email my cousin too.. He's a young scienctist working in the cancer fields in DNA research and had some studies of his published in pubmed so far... maybe i can get his interest. (our grandfather died of prostate cancer so i guess XMRV will be of interest to him).

tomorrow i may contact our local news station and see if i can get their interest.

maybe we can get this news going offical sooner if its all about the place!

 

[Navid]

If we want to fill a lull, let's talk about something that really matters. USA1, Algeria 0! (no offense intended to any Algerians - Congrats England).

right on CBS!!!!! what a great 2 days!!!!! our house erupted with joy this morning when that goal was scored...what a way to start the day!!!!

GO USA!!!!!!!
:victory::victory::victory::victory::victory::victory::victory:

 

[George]

ummmmm, cow patties my favorite

Dang nabit I go off to the country for a little R&R rolling in the cow patties and come back to find out I missed all the fun. (grins)

Actually I thought that this was how we all figured it would go down. Well, not everybody, (grins) I mean we know a bunch of stuff like;

1. We know by looking at the conference rosters that there are at least 20 papers that have not been published. They are being held up for some reason. It seems unlikely to hold up negative reports, and in fact it seems that the negative reports have just gone right on through. In addition positive reports that about XMRV but not about CFS have been published.

2. We know that there are no good test's that are FDA approved and mass produce-able at this time. That's bad if you have a new retrovirus that may well cause something nasty. Cause folks is gonna want a test and they are going to want it NOW! (big grin) I know I want mine. (big grins)

3. With the virus in about 4% if the population you have a huge potential for illness that could cost billions in a time of major recession. That's a big OUCH! for the folks in charge.

A.(I would also like to point out two small side points on this number of 4%. First to have a virus this wide spread would mean that it is either transmissible by contact during an incubation period or that it entered the population sometime in the middle of the 1800's. (No Virgina it could not be air born, grins) and that 7% number is XMRV and MLV's in the supply. MLV's have been in the blood supply for years with full knowledge of the AABB and company and have in fact been used to produce vaccines and do gene therapy for quite a while.​

B. It's been noticed recently that illnesses once thought to be childhood illnesses like Cystic Fibrosis are being found active in adults. Normally CF would be active in childhood and cut the life of person short or really short, depending on when it was found and treated. However, this genetic illness is now being recognized in adults. The genetic code stayed dormant until later in life and then clicked on causing adult onset Cystic Fibrosis. My point is that all those people walking around with XMRV may "potentially" become ill. At least the PTB's gotta figure it that way and want to be ready.​

So yeah the positive reports and the confirmation is coming. The hold up is that institutions like the NIH, CDC, AABB and the DHHS and others are working around the clock to get the necessary structures in place to deal with the problems that they are going to have to deal with when the information is released.

My guess is that the major information will be released in August mid to late this year. And like someone else pointed out about the new cycles it will take till about November for the general public to get the message. By then they should have things in place.

Well, that's my two paws worth, Woof!

 

[Dreambirdie]

Very sensible assessment, George. We will see how it all pans out in the woof of time.

 

[judderwocky]

What about the supposedly negative CDC study that is coming out? do we know if they were actually trying to supress this study from coming out? Alter is fairly well respected all over the world... it seems like many would take him seriously .

 

[George]

What about the supposedly negative CDC study that is coming out? do we know if they were actually trying to supress this study from coming out? Alter is fairly well respected all over the world... it seems like many would take him seriously .

Nice blog post Wayne, now that says it all. Hey Judderwocky, do you happen to know if for sure the CDC has a negitive study or was that a rumor that got turned into a fact????? (confused doggie looks) Could you point me in the direction of that info/fact please. Thank you, (slurp)

 

[natasa778]

We know by looking at the conference rosters that there are at least 20 papers that have not been published. They are being held up for some reason. It seems unlikely to hold up negative reports,

not sure about that - Huber negative study has been doing the rounds for a while now, rejected for publication twice so far if sources are correct... someone said could be 'cos papers don't like to publish repeat negative studies, doesn't sound right to me (BMJ I'm sure would JUMP on the opportunity ) but then who knows might be true...

 

[alex3619]

Hi bullybeef,

I think the Australian HIV prevalence is about 0.1%. If XMRV is at 7%, it is seventy times worse. Someone might not know anyone with HIV, but unless that person is a hermit then they know lots of people with XMRV. This will be social and economic dynamite - the third major crisis in recent times.

Bye
Alex

Another point is a question, how many people do you do whom has HIV/AIDS? I know of no one. If the figures are correct, your neighbour could have XMRV, and not even know it. It may proven to not be an exclusive disease, and that will also add to acceptance. As someone mention earily on here, members of our government now would be positive, doctors working now would be positive, people from all background, races , and creeds would be positive. We certainly won't be on our own here.

 

[George]

Just wanted to point out that the 7% number is XMRV AND MLV's. (big grins)

 

[alex3619]

Hi George,

Yes, I know about the MLVs. However, they are still not including the number of sick patients in this figure. It could go over 10%, in line with my earlier predictions of a worst case scenario, once people who are ill enough to not donate blood are factored in. The real question is what is the breakdown between MLVs and XMRV, and for that we will probably have to wait for the paper.

We also don't know if some of the MLVs are pathogenic or not. For all we know the people who have ME or CFS and are XMRV- could be MLV+. Research priorities in this area seem to be popping up all over the place - maybe someone influential in government will finally realize it and organize some funding? Wishful thinking, I know, but I refuse to be negative today.

Bye
Alex

Just wanted to point out that the 7% number is XMRV AND MLV's. (big grins)

 

[bullybeef]

Just wanted to point out that the 7% number is XMRV AND MLV's. (big grins)

Hi George, a member posted an email on here a month or two ago suggesting 6% general population prevalence (healthy plus diseased). Also, if you add the all the tested and results from the recent German study, the total comes to 6.6%. 7% isn't far off.

Remember <4% from the WPI study were healthy controls only. Has anyone ever added the total prevalence from healthy controls and ME participants in the WPI study? I bet it comes to approx....6%!!