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

[Navid]

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. "

is this for real???????? my jaw hit the floor when i read it.

 

[ixchelkali]

Does anyone know what HIV-X is? It is mention on the Alter's word doc as the 'next really bad one'! Don't tell me it's HIV+XMRV?

I thought it just meant a generic, unknown bad virus like HIV; the unknown next really bad one, whatever it is.

This could be really serious and certainly not something we wish to have.. .Im excited if this means that maybe we will be taken more seriously (hahaha Wesley..i've awaited the day for him to get egg on his face) ....but im really dreading what this could mean for us all.

Of course. But it IS something serious, those of us who have it already know that. Lives are being torn apart, lives are being lost. I think the excitement is that this might mean progress at being able to do something about it.
Yes, I've thought about the stigma, too. But we're already stigmatized. I've thought a lot about the transmission --who might I have given this to? That could be hard to live with, but far worse would be to keep transmitting it out of ignorance. At least if it's XMRV we have a chance to find out how to avoid spreading it more.
It either is caused by a retrovirus or it is not. Knowing is not going to change that. I will be happier knowing the answer, whatever it is. And I believe this news moves us closer to knowing. We've been in a long, dark tunnel for way too long. I celebrate seeing a glimmer of light.

Personally, I'm going to keep quiet about this until we get some official news.

Me, too, Esther. Except for here. And my husband. And my cat, who wanted to know why I was acting so strangely last night.

However, people suspected to have such were not left for years and year to rot while the alleged super-duper- beyond- any- doubt- PROOF of causation was established BEYOND DOUBT.

At what point did rational scepticism become 'denialism', at least in the eyes of others? At what point will this happen with the XMRV-CFS connection, if ever?


Sorry- rant over. I just find some of the appeals to 'science' and its presumed authority problematic. We've got serious abuse of science going on, and patients are being left to rot. I hope the latest news is positive. I just don't think the facts are going to get in the way of continuing ideologically informed mistreatment of a vulnerable population, while pious platitudes about waiting for the SCIENCE and PROOF (I'm not talking about forum members - just the whole reporting thing, blogs, certain other 'scientists' pronouncements etc.) which may never be quite enough (because in 'science' things rarely are).

Yes, with a lot of science there isn't "proof," but rather a preponderance of evidence. The bigger a change from the current thinking it is, the greater the amount of evidence is required. I remember when the geologist first came up with the theory of plate tectonics. Suddenly a lot of things that hadn't been understood made sence. Then they set about gathering evidence. At first there were a lot of geologists who didn't believe it, but now you'd have a hard time finding one who doesn't. There's just too much evidence to NOT believe it.

And certainly, if patients get well or improve when they're given anti-retrovirals, that becomes part of the evidence.

You ask "At what point did rational scepticism become 'denialism', at least in the eyes of others?" For AIDS, I think it was when the Secretary of Health and Human Services announced that the NIH had discovered the cause of AIDS. Remember that the French had discovered the HIV virus a year before, but they weren't taken seriously, because even the Pastuer Institute didn't have the prestige of the NIH. And because Dr Gallo had launched a whisper campaign disparaging their findings.

I know what you mean about "some of the appeals to 'science' and its presumed authority." But personally, I don't have a problem with science. I have a problem with those in authority who invoke the name of science when they're being unscientific. It's an abuse and a corruption of science, and I'm angry at them for that as well as for what they've done to patients while wearing the mantle of science.

And unfortunately, I'm afraid you're right that this news won't stop them. They'll be saying that XMRV causes neurosis, or that it's an opportunistic infection, or that hundreds of thousands of people are infected and only the CFS wusses think they're sick, etc. I think the biggest danger to us is if they can convince people that this disease isn't really serious, so there's no need to fund research. I keep imagining headlines like "Is a virus making you tired?"

But I guess I'm an optomist. I think we're reaching the point where the preponderance of evidence will begin to create it own momentum. I believe that real science will win out. Will the answer be XMRV? I don't know. It's an answer that makes a lot things make sence, though, so I think it's a real possibility.

And not just for ME/CFS patients. I suspect we may be close to unlocking the answers to many different chronic diseases. If people with similiar diseases don't have XMRV, might they have yet another undiscovered infectious human retrovirus?

From a scientific point of view, I find this an exciting time. I just wish I weren't watching from the point of view of the guinea pig (no belittlement of guinea pigs intended).

 

[bullybeef]

There are quite a few disingenuous comments in the blood workshop transcript that was posted a few weeks back. Heres a few snippets from that:

And the public is more willing to accept an unknown risk, which has a delayed ability to cause harm.

And perhaps public concern is disproportionate when it comes to blood safety. The public feels we have control of what we issue in blood products and we have a history with HIV to contend with. I don't think anyone in the U.K. if you flash a cow on the T.V. set, the first thought in their mind is probably BSE. So we've done a really good job with educating the public.

We didn't at that time prioritize XMRV, but I do think it fits under the category of YELLOW and we didn't prioritize at that time(regarding the red, orange, yellow alert priority)

We do not have a donor specific question. There is not one in use. We don't believe one is feasible because we cannot identify risk factors with any certainty. There are only experimental tests that have not been validated. It's difficult or impossible to ask a sensitive or specific question for CFS. If the studies have already been published of up to four percent donors is the reality, we would be losing many, many donors.

The specificity of XMRV infection in that four percent is unknown, and if we ask a CFS question, the sensitivity of that is also unknown if we're basing this on medically confirmed chronic fatigue syndrome because over 85 percent of CFS cases are unconfirmed and undiagnosed.

In humans, estimates from the genome sequencing project suggest that indigenous retroviruses now comprise some eight percent of our DNA. So we are walking retrovirus factories representing around 4,000 pro-viruses and 1,000 more solitary long terminal repeats.

And if you look at that paper just to show you the number of retroviruses many or all of these for which except for HTLV -- no HTLV is not on this table -- but we do not test this list this long -- and has been associated with cancer, neurological diseases, and autoimmune diseases.

We do know about the trigger that really got us thinking was that it has the potential of being transmitted in the blood. It is associated with white cells. There are certain amount of the viruses in the plasma. So because it has the potential for being transfused -- transmitted then that really got us going.

We have an agent (XMRV) that has very high scientific reason to act and we're not. We spend most of the time on this panel talking about XMRV. And whether you say 0 to 4 percent is prevalent in our donor population it's probably transfusion transmitted. It is retrovirus.

See: http://www.fda.gov/downloads/Biologi.../UCM214030.pdf

And these people are suposed to be portecting the public!!

 

[acer2000]

XMRV is really nothing like HIV, other than them both being retroviruses. one of the co-founders of XMRV told me that in the future, XMRV will not turn out to be a serious, life-threatening infection, once treated. it is much less cytoxic than HIV and has none of the accessory proteins.

they will have a vaccine....maybe it won't be so bad.....:-/

maybe

ugh.

They already have a vaccine for FeLV - the cat version of this virus. I wonder if they could even just repurpose that vaccine for XMRV in humans. Or if they can't do it, maybe they have a significant head start on one that will work.

The irony with XMRV is that, despite nobody putting 2+2 together and researching it as a human disease causing pathogen until a few years back, they have actually been researching MLV since before they even knew about HIV. There is a lot of accumulated knowledge about MLVs. The issue is translating that knowledge from animal models and experiments to human treatments.

 

[Rrrr]

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!

thank you, muffin. i'll be emailing all of these folks with the Wall Street Journal link right now! i hope everyone here does the same!

rrrr

 

[Rrrr]

also, there are some other emails of reporters/news outlets:

Julie Rovner at NPR: jrovner@npr.org
Science Friday at NPR (they had dr coffin on a few months ago about xmrv): scifri@sciencefriday.com
Rachel Maddow show (she cares about gay issues: maybe mention that this is the new HIV?): Rachel@msnbc.com

this is what i wrote in my email to them, and the email addresses muffin supplied:

Subject: Wall Street Journal: Nation's blood supply at risk with new retrovirus called XMRV

Hi there,

The Wall Street Journal has published about this. Will you also cover this topic? We hope so, because the nation's blood supply is at risk with this new retrovirus called XMRV (the other known retrovirus is HIV):

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

Thanks,
Rrrr

 

[dipic]

Of course. But it IS something serious, those of us who have it already know that. Lives are being torn apart, lives are being lost. I think the excitement is that this might mean progress at being able to do something about it.
Yes, I've thought about the stigma, too. But we're already stigmatized. I've thought a lot about the transmission --who might I have given this to? That could be hard to live with, but far worse would be to keep transmitting it out of ignorance. At least if it's XMRV we have a chance to find out how to avoid spreading it more.
It either is caused by a retrovirus or it is not. Knowing is not going to change that. I will be happier knowing the answer, whatever it is. And I believe this news moves us closer to knowing. We've been in a long, dark tunnel for way too long. I celebrate seeing a glimmer of light.

Brilliantly stated; needless to say, I couldn't agree more.

 

[Rrrr]

Folks,
Before we start bombarding media and politicians with emails, etc, can we please try to get our facts straight? We're not going to do ourselves any favors by coming off as ill-informed or hysterical (you know they will).

There is, as yet, no causal link between prostate cancer and XMRV. As I understand it (and I'm willing to be corrected), about 25% of prostate cancers studied show XMRV infection compared with 6% (sound familiar?) of nno-cancerous prostate tissue. That's still far from causal. It's an association with some prostate cancers. We'll know more later, but right now we have no justification for saying XMRV causes prostate cancer.

Ditto with XMRV and ME/CFS, but the association is so strong that I think an honest statement can be made showing the clear connection. Needs an expert. :Retro smile:

Also, there are many known retroviruses. There are many known retroviruses in humans. There are a few exogenous retroviruses known to infect humans -- HTLV-I (known to cause T-cell lymphoma and leukemia), HTLV-II, HTLV-III, HTLV-IV (all having unknown effects on humans as far as I know), HIV, and XMRV. Maybe more. Someone more knowledgeable than me knows, I'm sure. We can say that the known effects of the known human exogenous retroviruses is bad, referencing HTLV-I and HIV, but we can't say the only other known retrovirus is HIV.

I'm (I was) a researcher, but not in biology, medicine, or any related field. We need someone knowledgeable to give us a good, clear, full-of-impact, but strictly true statement for us to propagate.

Anyone willing to volunteer?

Thanks, SickofCFS, for keeping me/us in line!

Rrrr

 

[Rita]

http://www.sanquin.nl/ipfa/Upcoming...cc818c125706600483652!OpenDocument&AutoFramed

Here are the presentations in Zagreb. where Dr Alter says it is replicated the Science paper.

 

[justinreilly]

well, a lot of those drugs have already gone through safety rounds because they are HIV meds... so that will speed some things up... also MLV's were one of the original viruses they used when searching for anti HIV drugs... so there are, I believe, a whole bunch that have been shelved that didn't work on HIV, but would theoretically finally have a use. those would probably stlill have to go through safety testing ...but at least they don't have to be "discovered" first... that cuts down on research costs considerably... but you are going to be seeing a lot of groups looking at this and so i imagine they will probably be able to pull together a large research crowd and funding quickly...

Right. And, as Dr. Deckoff notes on her blog, CDC is currently passing out tenofovir to HIV negative gay males in SF to see how well it prevents HIV infection. All this stuff about it being dangerous for the crazy 'CFS' patients to take retrovirals is nonsense in her opinion, which makes sense to me.

 

[justinreilly]

Personally, I'm going to keep quiet about this until we get some official news.

This sounds like massive news, but I don't want to get too caught up in the excitement. Maybe the review of the CDC's, NIH, etc, etc studies will come down on the side of the negative CDC's work?

At this point, I'm really hopeful. It would be very strange for two entirely independent blinded studies to show a strong correlation between CFS and XMRV without that holding up... but I'm willing to wait for official news. It sounds like it will be coming soon.

Yeah, CDC's study (assuming it is negative) may be the valid one and WPI, NCI, CC, NIH and FDA are all wrong. Get real. We all know how objective and scientific CDC is when it comes to ME.

 

[justinreilly]

Hi ixchelkali,

Actually, that was the point I was trying to make. The amount of uncertainty in HIV-AIDS research alone makes the idea that "one can ONLY say cause is PROVEN when treatment is PROVEN" untenable. I note only 3 of Koch's postulates are fulfilled in the example you gave - there are four?- and that even achieving this took YEARS, as you say.

However, people suspected to have such were not left for years and year to rot while the alleged super-duper- beyond- any- doubt- PROOF of causation was established BEYOND DOUBT. And even now there are HIV + people who have not yet developed AIDS, whether due to prophylactic treatment or other reasons (and this is similar to XMRV+ 'normals', is it not?): indicating PROOF BEYOND DOUBT is not yet forthcoming, even in the HIV-AIDS connection. But this has not stopped people getting treatment and care and being taken seriously, instead of being told to think themselves better.

Ironically, the derogatory term 'denialist' - whereby people who doubt the HIV/AIDS link are castigated- could, technically, apply to those denying the XMRV/CFS connection now, yet it is not. Why not? (Rhetorical question)

Now I'm certainly not an AIDS 'denialist'. However, there will have been people who DID legitimately ('scientifically'?) question the causation certainly at the beginning of the 'epidemic'. At what point did rational scepticism become 'denialism', at least in the eyes of others? At what point will this happen with the XMRV-CFS connection, if ever?

I'm saying this not because I truly believe XMRV is THE causative agent of 'CFS' (there are so many other issues involved, not least other possible micro-organisms let alone the discrepant criteria of 'CFS), but because of how a HIGHLY uncertain, mostly implausible, default psychogenic explanation for uncertain somatic illnesses has become accepted uncritically by medics and the state while we wait for the 'science' to sort out the issue of XMRV.

And don't even get me started on the wasteful loss of animal life, and slowing down of progress, while scientists try to compare penguins and ostriches on 'animal models' of 'CFS': they can't even agree a decent RESEARCH criteria of HUMAN 'CFS' (if we take various excuses about not using the Canadian criteria in research at face value). Some scientists claim to establish animal models of chronic fatigue/CFS by exhausting mice! HOW are they going to establish a diagnosis of 'CFS' in some poor monkey? Why don't they just work on what they've got in human populations?

Sorry- rant over. I just find some of the appeals to 'science' and its presumed authority problematic. We've got serious abuse of science going on, and patients are being left to rot. I hope the latest news is positive. I just don't think the facts are going to get in the way of continuing ideologically informed mistreatment of a vulnerable population, while pious platitudes about waiting for the SCIENCE and PROOF (I'm not talking about forum members - just the whole reporting thing, blogs, certain other 'scientists' pronouncements etc.) which may never be quite enough (because in 'science' things rarely are).

Excellent, excellent points!!

 

[muffin]

sickofcfs We do have a "repository" of well written info on this forum

We do have a repository that the ultra smart, informed people have started on this forum so that they don't have to keep explaining over and over to the new people issues on XMRV, etc. I suggested that this repository also be used to grab and cut/paste into emails, posts, etc. so that we get our info correct and don't need to struggle to think and wind up with incorrect information.
Have to find the link where the smart people put all their well written comments. But we do have that resources.
I read the comments to the WSJ and thought they were quite fine. We are going to be mad as hell at the CDC and if that comes out in posts, fine. The CDC was well aware of Retroviruses way back in the 1980s and yet they destroyed a major DeFrietas study and then killed off all Retrovirus funding. Why? Why when HIV was very much on the scene AND a Retrovirus. So anger directed at the CDC is fine and justified.
All the other comments were good. No hysteria, just sick people who are desperate to get some sort of quality of life. I am sick of sleeping most of my life away - and have been doing just that for 16 long, miserable years. I am mad. Mad as hell at the CDC. See Hillary Johnson's WHY speech that gives a good overview of what the CDC has done to us for 28 years.

 

[Martlet]

We are going to be mad as hell at the CDC and if that comes out in posts, fine. The CDC was well aware of Retroviruses way back in the 1980s and yet they destroyed a major DeFrietas study and then killed off all Retrovirus funding. Why? Why when HIV was very much on the scene AND a Retrovirus. So anger directed at the CDC is fine and justified.

Well said, Muffin. One of the reasons I have been so cautious about the WPI findings was precisely because my hopes were raised so high by the DeFreitus study ... then that was it. I can't wait for the paper to come out, for this to be official and then to see what they are going to do about it.

 

[justinreilly]

STIGMA: The way I see it is, we're already stigmatized, and some sufferers were berated with atrocious labels like the 'yuppie flu' remark!! CDC cover ups in the 80's, and the buried retroviral link of the early 90's. The rest of that decade came with the undeserving sick label, and 'you don't look that ill', or, 'you just need to do some exercise'! We were all lazy, cake eaters! All this misinformation was fed to the media from various sources whom were supposed to be helping us, not hindering us.

XMRV should add a grave reality towards ME, especially if it is proven to be infectious. We'll all still be sick for a while, but I really doubt people could treat us any worse. There is so much sympathy around when it comes to disease these days. HIV/AIDS had to cope with the 80's homophobia. Nowadays, a child staring at a physically disabled person is reprimanded by the parents. Well I would. And the other positive of serious research funding, hopefully leading to treatment, in fact just having a real ME specialist would be nice.

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.

And we will get what we've always deserved, to be taken seriously.

I very much agree!

 

[muffin]

All I did was take that press release and send it on to the list of contacts. I said nothing more than that. I thought I would give these people background for when the real study hits. I don't know if the WSJ already had this press release or if she got it from me (I sent it to them at 10:30am today and it post at 6pm tonight). I suggest sending the press release and the blood supply statement off to the media so that they can start their research for when the real study comes out -- and when they and others realize the dire significance of what XMRV in large numbers and in the nation's blood supply could possibly mean. We CFIDS/ME sick understand just how bad this situation is/can/will be, but the public and media may not yet understand just how awful this new information is and what it may mean to everybody.

I was really just giving the media a "heads up". No thinking from me since I can't think...

 

[jeffrez]

I read the comments to the WSJ and thought they were quite fine. We are going to be mad as hell at the CDC and if that comes out in posts, fine. The CDC was well aware of Retroviruses way back in the 1980s and yet they destroyed a major DeFrietas study and then killed off all Retrovirus funding. Why? Why when HIV was very much on the scene AND a Retrovirus. So anger directed at the CDC is fine and justified.
All the other comments were good. No hysteria, just sick people who are desperate to get some sort of quality of life. I am sick of sleeping most of my life away - and have been doing just that for 16 long, miserable years. I am mad. Mad as hell at the CDC. See Hillary Johnson's WHY speech that gives a good overview of what the CDC has done to us for 28 years.

I agree with all of that. The CDC has been active and complicit in one of the most disgraceful scientific cover-ups in history, one that has negatively impacted potentially millions upon millions of lives. They are going to have to pay for their willful negligence and criminality in one way or another. If someone thinks a few negative comments here and there on the internet are bad (and I didn't see anything even remotely out of bounds on that blog), just wait until XMRV is fully legitimized and the sh!t really hits the fan. I see massive lawsuits in our/their future, and hopefully even criminal charges for those directly responsible.

 

[muffin]

Justinreily said..

"Yeah, CDC's study (assuming it is negative) may be the valid one and WPI, NCI, CC, NIH and FDA are all wrong. Get real. We all know how objective and scientific CDC is when it comes to ME."

Quite truthfully, do we even care what the CDC comes out with anymore? They are in a "damned if they do, damned if they don't" situation. Either way, positive study or negative study, the CDC is in big trouble since the FDA and NIH (and WPI, NCI, CC) already said it was a positive.

If the CDC comes back with a negative study, then we all just say that the CDC is continuing to damage CFIDS research. Damage done to CDC. If the CDC comes back with a postive study, then they are in trouble still because it is/will be common knowledge that a Retrovirus existed for 30 years and they knew and killed off research. The CDC can not win either way at this point. They are like a rat caught in a trap. And I love it. I plan on making sure that everyone knows that the CDC knew about a Retrovirus but damaged the replication of it and then killed off all further Retrovirus research - until the WPI (a 2 year org in rented University space) discovered the link. Gee, $150 Million over 30 years and the CDC has made no inroads on CFIDS? Why?

Sorry guys. So very tired can't think or sit up anymore.

 

[judderwocky]

that is a REALLY good point ... the first generation hiv meds are probably not something anybody wants to really take if they dont have to... but a lot of them ARE remarkably safe and getting better... its something the industry has worked to improve.

and also... yes the CDC is dispicable with the way they handled this. aids acitivists went through this kind of crap and now they have documentaries showing what jerks some people were. at least they can't take back the stuff they put in print.

 

[acer2000]

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

Yeah but consider this. Thats the incidence of HIV *now* - 30 years after it was "discovered". The incidence of new infections of HIV in developed countries is almost nothing now due to prevention, awareness, treatment, etc... Many of the original people infected with HIV in the early 1980s died, so the worldwide numbers as a percentage of population went down over the years.

This is of course with a few exceptions - certain African countries, maybe China, and certain urban settings (Washington DC, Detroit, ie).

So I guess you need to compare the theoretical incidence of XMRV now, before its controlled to the incidence of HIV at the peak of the epidemic to make it a fair comparison.