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

[VillageLife]

I think we should have one day this week where we all email as many important people involved in CFS/XMRV as possible!
People from the NIH, FDA, CDC and blood banks and so on...all together on the same day (hit them in one go!)
Does anyone want to make a list of all the people they think should be contacted and a list of there email addresses? What do you think?
We could make a new post for this ?

 

[natasa778]

How solid's the source on the Huber paper being rejected?

I've sent you a pm

Generally a journal doesn't want to waste space on a redundant paper that won't be cited much. But since this is by far the hottest biomedical issue in recent memory, I don't think that applies here. There will be no lack of attention paid to the paper, whatever it says.

excellent point!

 

[alex3619]

Hi Cort

I tried to get Australias national broadcaster interested in this for its in depth science show. That was several months ago and I am still waiting - I think it was just filed or something. Once the paper comes out, or there is official acknowledgement, I will give it another go.

I also tried to put the human interest side of things in a good light, including the story behind the WPI. That could make this story more appealing over a whole range of TV shows. However, I have tried to limit this to those shows that do in depth reporting and not just sensationalist trash - hype is going to be a problem, and I'ld like to see real reporting rather than nonsense.

I can see a movie in the works. Also some documentaries...

Bye
Alex

You gotta think this is going to be on the news programs - Dr. Donnica get those vocal cords ready. If XMRV really works out, and I'm getting ahead of myself - ie is a cause of CFS - then how CFS was ignored, how a little research Institute created by the parents of a severely ill daughter with CFS made the big discovery while the NIH and CDC slept- that's book stuff! That's 60 minutes stuff. That's an inspiring David vs Goliath story. That will get around. and

 

[alex3619]

Hi villagelife

I have been planning to write another email to every health minister in Australia, plus their opposition counterparts. These are the people in charge of state and federal health decisions. I have simply been waiting for official confirmation of the WPI results. That could be only days away now.

My previous emails have only been to our federal health minister. Neither she nor her staff members have replied as yet.

bye
Alex

I think we should have one day this week where we all email as many important people involved in CFS/XMRV as possible!
People from the NIH, FDA, CDC and blood banks and so on...all together on the same day (hit them in one go!)
Does anyone want to make a list of all the people they think should be contacted and a list of there email addresses? What do you think?
We could make a new post for this ?

 

[CBS]

Blood safety deliberations concerning XMRV

Does anyone know anything about the two bottom statements from this slide??
Does anyone know anything about the two bottom statements from this slide??


XMRV: current status
Controversial literature, inconsistent findings for viral markers in PCa, CFS, healthy controls; no causality established
Transfusion transmission theoretical
No intervention
Test methods not yet standardized
General concern when HIV seen as a model: species jump, potential for mutation
But, note apparent stability of viral genome to date
Specific interest, involvement from CFS affinity groups and their surrogates
CBS, Australia, NZ deferral for CFS
7 recent enquiries to ARC
Press release on efficacy of pathogen reduction

Those two statements are most likely connected to the statement above them - "Specific Interest, involvement from CSF affinity groups and their surrogates."

In the transcript of the May 11, 2010 meeting...:

UNITED STATES FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
EMERGING INFECTIOUS DISEASES: EVALUATION TO IMPLEMENTATION FOR TRANSFUSION AND TRANSPLANTATION SAFETY
(DAY 1)
EVALUATING EMERGING INFECTIOUS DISEASES (EIDs) FOR TRANSFUSION SAFETY"

...there was a lot of talk about the ways that public interest can impact blood safety policy, whether or not public interest should impact blood safety policy, what to do when there is no verified causal link to a disease, the ethics of doing nothing when there's a known pathogen with a suspected but unverified disease connection, the cost of doing something when you don't know if there is an associated disease, the various permutations of what that something might be, how would you even word a request for CFS patients to self-defer.... And on, and on, and on.

I hope that I've captured the flavor of the meeting if not the content. It's a riveting read (No, really it is. OK, some parts are interesting). One salient point (and this is probably an over simplification) is that Dr. Dodd (American Red Cross) is clearly concerned about the costs of a panic. Dr. Alter (NIH) is concerned about waiting too long to do something when we know there's a problem. PETER R. GANZ, Director, Center for Biologics Evaluation Health Canada also shared the Canadian experience to date. Apparently the US blood supply differs from many other countries in that the US supplies a broader range of blood products (for the world) and that creates additional costs/challenges when it comes to testing for, and the eradication of pathogens.

One of the take home messages from his presentation at the IPFA/PEI 17th Workshop seems to be that we waited a bit longer than we should have before taking aggressive action against West Nile Virus (slide four shows the spread of WNV across the entire US beginning in 1999 (when we first learned that WNV was a threat) and 2002 (when we first started testing the blood supply for WNV).

Here's the link to all 370 pages:
http://www.fda.gov/downloads/Biolog...ts/WorkshopsMeetingsConferences/UCM214030.pdf

This is a very interesting peak into the deliberations going on right now within all of the groups tasked with blood safety as they grapple with XMRV (it was referred to a number of times but even when it wasn't being identified by name, it was the elephant in the room). The potential magnitude of XMRV along with the need for more scientific information seems to be weighing heavily on all of their deliberations - as it should.

ETA - There was also talk about the natural "viral flora" (not dissimilar to the bacterial flora of the gut) and that it would help a great deal if the public recongnized viruses as comprising 8% of our DNA and not freak out about every virus that is identified.

Personally, that's great from an evolutionary perspective (change my DNA and if I reproduce, maybe I have an ancestor that develops a really cool super power - like language or being able to walk on my hind legs) but I don't get the impression that viral flora are MY friend in the same way that some bacteria are healthy and assist with digestion and other immediately beneficial processes. I'm just sayin'...
​

 

[George]

Thanks CBS

Love the Avatar. I like the one with the baby in the dog bowl. My kinda kid. (grins)

This from the WSJ http://blogs.wsj.com/health/2010/06/23/further-evidence-of-an-xmrv-chronic-fatigue-connection/

By Amy Dockser Marcus

A report that a respected NIH expert supported an association between the XMRV virus and chronic fatigue syndrome is causing a buzz among CFS patient activists, researchers and clinicians.

According to a press release issued by a Dutch magazine, one of the slides presented at a recent workshop in Zagreb by Harvey Alter, chief of the infectious disease section at the NIHs clinical center, supports the link between XMRV and CFS reported last year in Science.

This is significant because studies published later by other groups have produced conflicting results. Alter is a well-known figure in the infectious-disease world; his research helped lead to the discovery of the hepatitis C virus.

Its what weve been waiting for, says Annette Whittemore, head of the Whittemore Peterson Institute in Reno, whose scientists were investigators on the Science paper. Her team went out to celebrate the report, although she says, I want to see [the data] published. She tells the Health Blog she is hoping that confirmation of her scientists work will help drive more funding to XMRV research.

A spokeswoman for the NIH said she couldnt comment on the report because the data havent been published yet, though she confirmed the presentation slides are authentic. Alter didnt respond to a request for comment.

The May 26-27 workshop was organized by the International Plasma Fractionation Association and the Paul Ehrlich Institute and hosted by the Institute of Immunology (IZM). To see Alters presentation, click here, then follow subsequent links to the available presentations and to the Alter presentation in session 4.

A slide titled Comments on the Agent Du JourXMRV, says the data in the Science paper are extremely strong and likely true, despite the controversy. The slide indicates that the association of XMRV with CFS is very strong, but causality not proved.

In addition, Alters presentation estimates the incidence of XMRV in the donor blood supply at 3% to 7% versus the nearly 4% cited in the Science paper.

And at the bottom of the slide, in a bullet point that launched all the buzz, this statement: We (FDA & NIH) have independently confirmed the Lombardi group [which published the original Science paper] findings.

Image: iStockphoto

 

[Impish]

Those two statements are most likely connected to the statement above them - "Specific Interest, involvement from CSF affinity groups and their surrogates."

In the transcript of the May 11, 2010 meeting...:

UNITED STATES FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
EMERGING INFECTIOUS DISEASES: EVALUATION TO IMPLEMENTATION FOR TRANSFUSION AND TRANSPLANTATION SAFETY
(DAY 1)
EVALUATING EMERGING INFECTIOUS DISEASES (EIDs) FOR TRANSFUSION SAFETY"

...there was a lot of talk about the ways that public interest can impact blood safety policy, whether or not public interest should impact blood safety policy, what to do when there is no verified causal link to a disease, the ethics of doing nothing when there's a known pathogen with a suspected but unverified disease connection, the cost of doing something when you don't know if there is an associated disease, the various permutations of what that something might be, how would you even word a request for CFS patients to self-defer.... And on, and on, and on.

I hope that I've captured the flavor of the meeting if not the content. It's a riveting read (No, really it is. OK, some parts are interesting). One salient point (and this is probably an over simplification) is that Dr. Dodd (American Red Cross) is clearly concerned about the costs of a panic. Dr. Alter (NIH) is concerned about waiting too long to do something when we know there's a problem. PETER R. GANZ, Director, Center for Biologics Evaluation Health Canada also shared the Canadian experience to date. Apparently the US blood supply differs from many other countries in that the US supplies a broader range of blood products (for the world) and that creates additional costs/challenges when it comes to testing for, and the eradication of pathogens.

One of the take home messages from his presentation at the IPFA/PEI 17th Workshop seems to be that we waited a bit longer than we should have before taking aggressive action against West Nile Virus (slide four shows the spread of WNV across the entire US beginning in 1999 (when we first learned that WNV was a threat) and 2002 (when we first started testing the blood supply for WNV).

Here's the link to all 370 pages:
http://www.fda.gov/downloads/Biolog...ts/WorkshopsMeetingsConferences/UCM214030.pdf

This is a very interesting peak into the deliberations going on right now within all of the groups tasked with blood safety as they grapple with XMRV (it was referred to a number of times but even when it wasn't being identified by name, it was the elephant in the room). The potential magnitude of XMRV along with the need for more scientific information seems to be weighing heavily on all of their deliberations - as it should.
​

Here is my favorite statement from the document...

"I spent a little time considering whether
there are any precedents from things that we've done since
the appearance of AIDS. And I find really not a lot; HTLV
we took rapid action because after all, it was a
retrovirus. "

WTF... They acted quickly with HTLV but sit on their hands with XMRV...

 

[Eric Johnson from I&I]

Cat's outta the bag. A Wall St Journal blog just broke the news. I think that will push the wonks and geeks to "fess up" pretty soon about what the deal is, and maybe the journal will just put up the pre-print already.

 

[Impish]

Here is another

" In the context of XMRV, I think that there is an
emergency, but it's a perceptual emergency. And I'm not
as well versed in the tools of managing that, but I think
that what we need to do is to manage people's reactions
rather than people's safety at this point. I hope during
the day that somebody can come up with a mechanism to
manage that. "

 

[CBS]

Here is another

" In the context of XMRV, I think that there is an
emergency, but it's a perceptual emergency. And I'm not
as well versed in the tools of managing that, but I think
that what we need to do is to manage people's reactions
rather than people's safety at this point. I hope during
the day that somebody can come up with a mechanism to
manage that. "

That was our good friend Mr. Dodd of the ARC. I do wonder if he thought through all of the implications of saying that in a public meeting.

 

[Impish]

It is well known that people in general are TERRIBLE at managing risk. Hence the economic meltdown, the oil leak, etc. They don't take into account the events that are the far edge of probability.

It could be that this statement will end up being like those of the CEO of BP.

 

[George]

Yeah, don't get me started on that document Impish! growlllllllllllllll!

 

[Otis]

Cat's outta the bag. A Wall St Journal blog just broke the news. I think that will push the wonks and geeks to "fess up" pretty soon about what the deal is, and maybe the journal will just put up the pre-print already.

Thanks Eric. Here's the link.

 

[muffin]

BANG THE DRUMS! Keep emailing this report to all media - TV, Cable, Newspapers, etc.

Here is a list of the media types that I sent an email to this morning with this heading: "FDA and NIH confirm WPI XMRV findings -- This is the virus that is known to cause Prostate cancer and MAY cause CFIDS/other cancers/diseases -- CRITICAL!"

basu@usmedicine.com; HEALTH@CNN.COM; health@washpost.com; info@ap.org; info@healthkey.com; info@theatlantavoice.com; insideajc@ajc.com; investigate@newschannel5.com; listen@ajc.com; NEWSTIPS@CNN.COM; cdcinfo@cdc.gov; health@washpost.com Cc: tom.corwin@augustachronicle.com; insideajc@ajc.com,amy.marcus@wsj.com,wsj.ltrs@wsj.com; newseditors@wsj.com; a.murray@wsj.com

Email this report off everywhere you can think of so that it gets picked up and spread all over the world. This is free advertising for us and gives the media folks a quick story to run with.
Email to your local newspapers, TV stations, and the major media. Think I'll email it to the Economist while I'm thinking about it. Still need to hit ABC, CBS, NBC and so on...

EMAIL THIS STUDY AND SPREAD THE WORD. THIS WILL HELP COUNTER ANY NEGATIVE COMMENTS/DOCUMENTS FROM THE CDC AND ALSO SMASH THEM IN THE FACE FOR GROSS CRIMINAL ACTIONS. OH YES, I MEANT CRIMINAL!

 

[julius]

Muffin,

I don't believe it's yet known to cause prostate cancer.

 

[Rrrr]

I think we should have one day this week where we all email as many important people involved in CFS/XMRV as possible!
People from the NIH, FDA, CDC and blood banks and so on...all together on the same day (hit them in one go!)
Does anyone want to make a list of all the people they think should be contacted and a list of there email addresses? What do you think?
We could make a new post for this ?

YES, let's do this. Muffin likely has that list already. Muffin...?

 

[justinreilly]

In print at a closed conference is NOT the same as published. That information was not intended for public announcement. Therefore this is preliminary, and until a paper or public announcement appears, announced by proper channels, this is still a rumor.

Presented, in writing, at a scientific conference by a high-up respected virologist at NIH that NIH and FDA have confirmed the Lombardi findings. We have copies of that writing. I characterize this as more than a rumor.

 

[liverock]

Second any definitive study but hopefully point out where the other five or six researchers went wrong. Was it all due to lack of culturing - as Dr. Mikovits pointed out so long ago - or is it something else?

It could be due to lack of culturing(there are several strains of XMRV), but Dr Klein in his video on XMRV,CFS and prostate cancer, made the point using maps and diagrams,that several viruses in the past in the same family as XMRV, (the Murine Leukemia family),that could cause certain cancers have been found to be only active in certain geographical locations in a meaningful way.

This could well be one of the reasons for a delay in announcing the results of the NIH/FDA study. The last thing any governmental body would want to announce to the public is a new infectious retrovirus when they dont know how far it is widespread.

Any announcement under these circumstances would have to be carefully thought out and worded to prevent panic and downplay the seriousness of the possibilities.

The Dr Klein video on XMRV,CFS and PC discusses tthe question of false studies and possible answers due to XMRV not being universally spread throughout the world.(Its near the end of the video). This is probably the most up to date, factual lecture on XMRV and IMO should be essential viewing for everyone.

http://webcasts.prous.com/netadmin/...u1qwE1eVOlUxVQXZXkecU7el4AF32YmYnN7MsttogZmU=

 

[justinreilly]

I'm not feeling very good today, so if this comment is redundant or just super obvious pardon me, but did anyone else notice on slide 27 (the 1st un-numbered slide towards the end of the presentation) that it lists XMRV as a prioritized EID threat as of August 2009 and also says "The only barriers to rapid development and implementation of such diagnostic testing capabilities are regulatory, not technical." Regulatory, not technical??!!

Nice catch!

Wow! I admire how this guy actually tells the truth! We need to publicize this snippet of his!

 

[dannybex]

Muffin,

I don't believe it's yet known to cause prostate cancer.

That's my understanding as well. I think XMRV was found in a percentage of aggressive prostate cancer cases. Before we email we need to be as accurate as possible.

But great idea Muffin!