IASCFS/ME - Science and the Hold on XMRV Studies

[eric_s]

And you know what i bet if this really happens ( NIH u turn ) They will all just plain get away with it, they are the elephants, we are the mouses yeah probably with XMRV

No, they would never get away with it. There are other institutions that will continue their research and bring out the truth. And if there were none, we would create them. We are probably a couple of millions. We are not rich but what's 2'000'000*50 EUR or USD? Should be enough. I think the question is only how long this crazy situation that we're in right now will continue. I hope it will not be more than some weeks.

 

[free at last]

No, they would never get away with it. There are other institutions that will continue their research and bring out the truth. And if there were none, we would create them. We are probably a couple of millions. We are not rich but what's 2'000'000*50 EUR or USD? Should be enough. I think the question is only how long this crazy situation that we're in right now will continue. I hope it will not be more than some weeks.

Hi Eric well yes that might be so, but others finding the truth is not the same as the NIH releasing the truth, i wish i had yours and others confidence, but i just do not. All seems way way to fishy to me. time will tell, but im prepared for a shock read when that paper surfaces. if im wrong ill be elated just like everyone else ,im truley hoping for a end to a disease, that in many eyes, has never really ever existed, we know there wrong, but proof has been so difficult, especially when that proof is ignored, or explained away for other theorys that suit the status quo more for them, which is why i think this sorry saga is unfolding the way it is. If i am wrong it will be like a medical bomb going off. Something the CDC have never wanted are we really to belive they are going to lose control very soon, have some explaining to do very soon. And admit they was wrong and apologies very soon. Find all that too hard to belive. Then theres the uk situation, exactly the same

 

[eric_s]

Yes, it's hard to imagine for me too, both outcomes. If the XMRV connection is confirmed it will be an earthquake but also i can't believe the WPI and Alter have been wrong and not found the error for so many months now. So i just wait.
I agree that it's not the same if others than the NIH or CDC release a result but if it's done again and again it will convince everyone in the end.
Btw, you've just reached 100 posts

[Edit: For some reason it says "an an earthquake" in my text even though i didn't write "an" twice. Is there something wrong with this software?]

 

[eric_s]

On July 2nd, the Association said in the CFIDS Link:



I didn't go back and check, but I'm pretty sure the Association's Facebook page included a similar statement about our support for immediate publication of both studies, and that we were advocating for that to happen.

On a personal note: I am more than happy to answer questions and consider constructive criticism of the Association's work. But I really would appreciate common courtesy instead of comments like "ROFLMAO, Working with the gov'ment? " or "Are they helping the CDC perfect that test that finds XMRV in fake samples?"

Hi jspotila

I think there might be a mistake on your XMRV page (http://www.cfids.org/xmrv/default.asp).
Under "Blood Safety Issues" it says

Analytical panels of blinded samples of XMRV and negative controls were tested by six laboratories (including the Whittemore Peterson Institute) to assess results using different methods. All six laboratories were able to detect XMRV in whole blood using nucleic acid testing and four of five plasma RNA assays performed well. CDC's whole blood assay was the most sensitive, while WPI was the only lab reporting an unexplained false positive result on a negative sample.

The picture there can't be amplified but i think the table on it shows for each lab and quantitiy of virus in a sample what number of samples with that quantitiy of virus in it the lab found to be XMRV positive. The top row seems to say "0 cells per ml". The WPI and one FDA lab (i think Lo) have a green color there, i think this means that they have found one sample without XMRV in it to be positive (false positive). So aren't you wrong to say that the "WPI was the only lab reporting an unexplained false positive result on a negative sample"? Or could Lo's false positive be explained?
Thanks for clearing this up.

Eric

 

[V99]

Should it not also be made clear that there is, as yet, no way of knowing if that sample already contained XMRV.

 

[jspotila]

Hi jspotila

I think there might be a mistake on your XMRV page (http://www.cfids.org/xmrv/default.asp).
Under "Blood Safety Issues" it says The picture there can't be amplified but i think the table on it shows for each lab and quantitiy of virus in a sample what number of samples with that quantitiy of virus in it the lab found to be XMRV positive. The top row seems to say "0 cells per ml". The WPI and one FDA lab (i think Lo) have a green color there, i think this means that they have found one sample without XMRV in it to be positive (false positive). So aren't you wrong to say that the "WPI was the only lab reporting an unexplained false positive result on a negative sample"? Or could Lo's false positive be explained?
Thanks for clearing this up.

Eric

Hi Eric, I have not seen the graphic full size myself. My understanding is that the report on the XMRV page is a summary of the presentations at the FDA Blood Products advisory committee on July 26th. I have not seen a transcript of the presentations yet, so the false positive report is based on those who attended the meeting. If I can get more info on the graphic, I'll share it here.

 

[garcia]

Hi Eric, I have not seen the graphic full size myself. My understanding is that the report on the XMRV page is a summary of the presentations at the FDA Blood Products advisory committee on July 26th. I have not seen a transcript of the presentations yet, so the false positive report is based on those who attended the meeting. If I can get more info on the graphic, I'll share it here.

The graphic is extremely poor quality (why make it so small?), but you can just about discern that the top row refers to zero copies per ml, in other words a negative sample. Both the WPI and the FDA seem to have scored 1 out of 6, i.e. they both found 1 false positive. [as an aside it is extremely difficult to say what exactly a true negative is, since the person in question could have been infected with xmrv]

This seems to contradict with the text of the report which claims that only WPI got a false positive.

If you could clear up this discrepancy it would be much appreciated.

 

[Martlet]

Totally off topic but I had to reply to the snake question. Good on you, George! We found a tiny pencil-sized Prairie King in our basement several years ago, bought a small aquarium and over-wintered him (it was too late in the season for him to stand a chance of surviving, so small was he) then released him the following spring. He was a cutie. Got quite fond of him.

 

[kurt]

Courtesy is extended when interests are not in conflict.
[/B]

MODERATOR - Do you mean courtesy to a forum member, or to an outside organization? Just to be clear, the forum rules about treatment of forum members apply in all cases, and are not suspended when a forum member believes someone is wrong in their views, or believes there are conflicts of interest.

 

[Cort]

Are they helping the CDC perfect that test that finds XMRV in fake samples?

As you may remember if you think about it a bit, the CFIDS Association is partnering with Glaxo-Smith-Kline in the first Biobank study to look for XMRV in a near replication of the WPI's cohort. The patients must have acute onset and they are looking for patients with NK cell abnormalities. GSK, by the way, is the pharmaceutical company that was engaged with WPI to start whipping out a treatment trial. They backed off when the negative studies started pouring in. The CFIDS Association jumped in with their own money to produce perhaps the best XMRV study underway.

Does that sound like they are assisting the CDC in finding XMRV?

Maybe we should ask Suzanne Vernon whether she's helping the CDC find XMRV? She's the one that publicly wrote the CDC study was an exercise in how not to find XMRV.

Does that sound like these organizations are partnering up?

The CFIDS Association has been the CDC's CFS programs worst enemy for several years now. At some point that will sink in (perhaps) or it may be that some individuals will prefer to hold onto their interpretation that the CDC and CAA are kissing cousins. While you can certainly argue that the CAA should have been more aggressive with the CDC in the past, (I don't believe they were ever that close), in any case, it is certainly not what the events of the past two or three years support. They have been doing nothing but butting heads for several years now.

I can give you more examples if you wish - I've done that several times now - somewhat fruitlessly it seems

There are several things to question the CAA about, for sure, but some of these issues are not relevant in my opinion.

 

[Cort]

I hate saying this: WE must be the ones to push. Were it not for the Whittemore's and their sick child, we would be stuck back in previous decades, regardless of what these Advocacy orgs do or have done for us. Sad but so. I'm sure these orgs mean well, but, what really has been done in the last decade for us? Funding for real research from the Hill? Taking the CDC/CFS program/Reeves down? Really, I think that WE took Reeves down with the constant screaming about him and the CDC/Frieden may well have known we were right. I will give credit to the CAA for taking a really good shot across the bow at a conference when they went after the CDC/CFS people for wasting money. Now that was GOOD. But again, WE, the sick, must be the ones to do our thing. We must fight, it's just that simple - I think anyway.

What earmarked charity money you have should go to WPI and PR. Sorry CAA, but it is the WPI, the Whittemores and Mikovits, et al that have done us the most good in the least amount of time. So that's where my very limited "charity" funds have to go. Kills me to use that money for research, a government job paid for by my taxes, when I would rather spend that money on helping dogs/cats and getting them "fixed", stopping abuse, and finding them true loving homes, etc.

I have to say I disagree with this

Taking the CDC/CFS program/Reeves down? Really, I think that WE took Reeves down with the constant screaming about him and the CDC/Frieden may well have known we were right.

I think the patients had only a minor effect on this. I don't think the CDC really cares about us much. .Patients have been screaming for decades now with no effect. What changed is that three groups finally came together. What allowed that to happen was probably the CAA's uncovering in early 2008 the massive financial waste in the CDC and then presenting it publicly at the CFSAC conference in late 2008 and saying Dr. Reeves had to go.

That kicked everything off. They had earlier asked the CFSAC to back them and they wouldn't while Dr. Reeves was a member of the panel. But Dr. Reeves left and six months later they issued a strong statement asking for his removal and so, finally, did the IACFS/ME. It was too late, though, once the Independent Review Group issued their laudatory report of the CDC, they closed ranks again. If the IACFS/ME and CFSAC had acted with the CFIDS Association earlier we possibly could have gotten Reeves and major changes in the program. Still there were strong statements from three major groups at that point.

Then it was the change of administration that did it. I assume that it was the combination of several things; the death of the Empirical Definition in the research community - something the CDC spent enormous amounts of money on, the unrelenting pressure from some of the professionals in the field and the CFIDS Association unrecovery of horrible waste in the program. For me the last was the strongest - it was black and white stuff - that program was wasting an enormous amount of money: how could you keep a manager on under such circumstances?

I think we were just icing on the cake actually. I'm sure we helped but my guess is that the other groups played the major role.

 

[Cort]

This is the IACFS/ME - its nice to have them on board but it usually takes quite a while for them to get anything done.

 

[Cort]

I too think the CCA need to be making it clear what CFS definations are being refered too. (has the CCA got an issue with the Canadian criteria one???)

The CCA should be setting good examples and as we all know.. definations not being put clearly.. causes CFS patients a lot of trouble.

The CAA posts a link - advertises! - a paper on the Canadian definition - and yet there's a question whether the CAA has got an issue with the Canadian Criteria (because they didn't put Canadian in there?)? Why would they post a link to a paper they have an issue with?

The CAA had an ENTIRE webinar on the definitions by LENNY JASON himself. Giving the foremost proponent of the Canadian Criteria a hour long webinar on it suggests to me that they do not have an issue with it.

http://www.cfids.org/webinar/series2010-past.asp#4

They also asked Lenny Jason to produce an article on the definition which they have on their website which I cannot find at the moment.

You can find their statement on the CCC here: http://www.cfids.org/cfidslink/2010/010607.asp#4r

 

[Cort]

RE: On a personal note: I am more than happy to answer questions and consider constructive criticism of the Association's work. But I really would appreciate common courtesy instead of comments like "ROFLMAO, Working with the gov'ment? " or "Are they helping the CDC perfect that test that finds XMRV in fake samples?"


I'm not on here often but it is pretty apparent.... Courtesy is extended when interests are not in conflict.

George... you are more than informed IMHO... keep pursuing the truth.

No, extending courtesy at all times is a key guideline for the forums.

Regarding REOFLMAO and other comments - working with the government in contrast to the needs of the patients is pretty severe and damning criticism of any organization and I would request that evidence be provided before any organization is labeled that way.

CAA and Government Funding - We are looking for rigorous inquiries are we not? For starters you have to ask if the CAA, in this case, needs government funding to run its organization or receives any government funding to do that. I believe the answer is no. If that's true they you have to ask what the CAA has to gain by giving preference to the government over the clientele that delivers all its funding. What do you get by tweaking your funders - the CFS community - in order to get in with the government? What is the cost/benefit analysis of that?

In fact, the answer has always been no. The CAA received government funding after it won the bid to deliver the media campaign on CFS....... It won a contract to deliver a campaign and then it used the money from that contract to deliver the campaign.

That money was used the run the media campaign
The CFIDS Association uses money from the CFS Community to run the CFIDS Association.

The two have nothing to do with each other. The idea that the CAA uses government money to run the organization has always, to my knowledge, been completely wrong yet that idea has pervaded some community for as long as I remember.

You have to figure out a different reason why the CAA is pretty conservative in some areas.

 

[garcia]

That money was used the run the media campaign
The CFIDS Association uses money from the CFS Community to run the CFIDS Association.

Thanks for clearing that up Cort. But I have to ask does this include Kim McCleary's $180,000 salary? Is that funded directly from patient donations??? If so I am flabbergasted.

 

[judderwocky]

So where is the CFIDS Association on this?

They continue to openly state that they think nothing is wrong at all or out of the ordinary. They are not only "behind" so to speak... but in some cases are playing directly into the DHHS strategy.

They restate anonymous quotes on behalf those "close to the paper" which is something I would have been fired for doing if I still worked at either of the organizations I used to do pr/media work for.

"To Andrea's original question: having spoken to several people closely connected to the FDA/NIH study who are here at the FDA meeting (including Dr. Alter), the PNAS paper will be published; the date is up to the journal. They each said that additional public attention and/or political pressure would be unwelcome. They want the data to speak for itself and for it to undergo the same critical analysis (once published) that is such important element of the scientific process." - CAA Facebook page


These are mistakes that are naive at best.

Allowing them to make statements anonymously... and especially statements like this. My thoughts:

First of all it allows them flexibility in crafting the final paper... without having to make an official statement there is no record of intereference by the government agency. They are avoiding directly talking about it in the Media and the anonymity is a part of the this strategy.

Two. This statement ommits the fact that it was not originally the journals decision. Originally it was reported the hold was at the DHHS. By not officially stating who was responsible they are able to juggle the thing behind the scenes and play on ambiguity.

Three. The above to give the impression that it was the media/patient groups that are interfering with the Scientific process at this point. It gives off the impression that said groups are basically instigators. By focusing on the response of the patient groups at the exclusion of their precipitating actions it allows the focus of what is unusual about this story to be the presence of patient groups and media attention...
EVEN IF THE CAA believes everything about the paper is going normally... and they completely disagree with the petition.. they still should not have relayed this comment because it reflects poorly on patient groups THE NEXT TIME THEY HAVE TO USE THEM IN A CAMPAIGN.
The next time these "unwelcome" forces are used in a media campaign... they just have pitch that much harder for their "intereference" to be welcome... it just produces additional problems in media strategy later on, with a patient group they still need to look its best.

The combination of the above allow them to basically control the final data set in any way they want.

Five. How many times does the CAA complain about how hard it is to get people to write about this issue, and yet they turn around slap all the journalists and "additional attention" in the face by saying it is basically unwelcome.

That is just stupid.

I would have been fired on the spot had i done this at my previous places of employment.

One of my previous jobs also actually involved media and relations work with the DHHS and NIH... I have done media campaigns for this kind of work that have been sent to thousands of individuals. (issues way more "sensitive" and "controversial" than this)

so i have experience doing media work with these agencies.

plain stupid.


they want to make themselves look relevant by relaying "inside information"... they are journalists so they naively think this is a good idea. journalists are trained in a different set of media skills than activists.

in media and relations work... sometimes its a good idea to just keep your mouth shut if all you have is information that is going to help the other side.

sorry to call a spade a spade. i've never been the person to keep my opinions to myself. and i am floored right now.

 

[Cort]

Thanks for clearing that up Cort. But I have to ask does this include Kim McCleary's $180,000 salary? Is that funded directly from patient donations??? If so I am flabbergasted.

Everything comes from patient donations so far as I know. I don't know if that's the exact salary but whatever it is it is alot of money -particularly in relation to most of us. The CAA says that its a pretty much standard salary for someone in her position and I believe that as well. The Board has to approve her salary, I believe, and if you look at the board they look like pretty smart and independent group of people a good number of whom have CFS.

My guess is that people want the CAA to be more aggressive and inflammatory in the advocacy area and because they are not being more aggressive they are coming up with reasons why.....one of which is kowtowing to the government. I think the CAA believes they are working in the best way possible - for the patients. They are trying to achieve results...they want to achieve results - that is their focus and they do actually achieve results - not as many as we would wish but they do.. Relative to other advocacy organizations they are a small drop in a big pond.

Why has the CAA been unable to change the world on CFS for us. Check this out: I still remember doing lobby day and seeing advocates for multiple sclerosis all over the place. We were seeing staffers and watching them get into see Senators and Congressman. They were obviously MUCH MORE EFFECTIVE at getting access to the policymakers than we were. Why?

On the face of it they shouldn't be. THere are three times as many people with CFS in the US than MS patients (approx 1,000,000 - 330,000). By numbers alone we should be getting into those offices.

The difference is in the two organizations. The MS Society got $50 million in support from its patients in 2008. Its total assets are well over $100 million (you couldn't tell from its website ). The CFIDS Association gets less than a million dollars from its patients and its total assets are around $2,000,000.

You have an organization with 50 times less resources battling with an organization with 50 times more resources for attention on the Hill. We know who's going to win that battle. And its not just MS, its breast cancer, heart disease, diabetes, alzheimer's, parkinson's etc. We are going to lose ALL of those battles - all of them! We are always going to be at the very bottom of the stack.

Of course there are lots of reasons why raising money and advocating for CFS is much more difficult. Only 20% of CFS patients are reportedly diagnosed. The community is poor, it is divided over lots of different issues, and its not a happy community; its a community that, by and large, XMRV being the notable exception, is more interested in what's wrong than in building on what might work.

Its a community that is steeped in its history - that lives in its history - no knock there - there's not alot of positive stuff going on - but still that means there is not alot of attempt to transcend history and build a positive force for change. To some extent you have to do that...you have to give up your gripes and anger in order for something else to show up. Nelson Mandela did that with S. Africa; he declared this was a new day. We're still in the blame mode - we're not in the 'fixit' mode. We don't have a vision for the future we're working towards.

 

[judderwocky]

Everything comes from patient donations so far as I know. I don't know if that's the exact salary but whatever it is it is alot of money -particularly in relation to most of us. The CAA says that its a pretty much standard salary for someone in her position and I believe that as well. The Board has to approve her salary, I believe, and if you look at the board they look like pretty smart and independent group of people a good number of whom have CFS.

My guess is that people want the CAA to be more aggressive and inflammatory in the advocacy area and because they are not being more aggressive they are coming up with reasons why.....one of which is kowtowing to the government. I think the CAA believes they are working in the best way possible - for the patients. They are trying to achieve results...they want to achieve results - that is their focus and they do actually achieve results - not as many as we would wish but they do.. Relative to other advocacy organizations they are a small drop in a big pond.

Why has the CAA been unable to change the world on CFS for us. Check this out: I still remember doing lobby day and seeing advocates for multiple sclerosis all over the place. We were seeing staffers and watching them get into see Senators and Congressman. They were obviously MUCH MORE EFFECTIVE at getting access to the policymakers than we were. Why?

On the face of it they shouldn't be. THere are three times as many people with CFS in the US than MS patients (approx 1,000,000 - 330,000). By numbers alone we should be getting into those offices.

The difference is in the two organizations. The MS Society got $50 million in support from its patients in 2008. Its total assets are well over $100 million (you couldn't tell from its website ). The CFIDS Association gets less than a million dollars from its patients and its total assets are around $2,000,000.

You have an organization with 50 times less resources battling with an organization with 50 times more resources for attention on the Hill. We know who's going to win that battle. And its not just MS, its breast cancer, heart disease, diabetes, alzheimer's, parkinson's etc. We are going to lose ALL of those battles - all of them! We are always going to be at the very bottom of the stack.

Of course there are lots of reasons why raising money and advocating for CFS is much more difficult. Only 20% of CFS patients are reportedly diagnosed. The community is poor, it is divided over lots of different issues, and its not a happy community; its a community that, by and large, XMRV being the notable exception, is more interested in what's wrong than in building on what might work.

Its a community that is steeped in its history - that lives in its history - no knock there - there's not alot of positive stuff going on - but still that means there is not alot of attempt to transcend history and build a positive force for change. To some extent you have to do that...you have to give up your gripes and anger; basically your heart felt beliefs and interpretations in order for something else to show up. Nelson Mandela did that with S. Africa; he declared this was a new day and they would be moving on.

Money might be one issue. But again, I see serious issues with their attempts at creating additional funding streams. MS gets money because of the PR. If they wanted better funding, they should be doing better PR.

I've pointed out just one of the issues I have with their PR.... but its really a systemic approach with them.... for instance a lot patients aren't really happy with their reserach funding. Its hard to convince the government to study retroviruses when the largest cfids non profit group doesn't put any money towards them (*please correct me if this is wrong... i can't find any evidence of it but maybe i overlooked). So, they need to start looking at their research budget as part of their pr....

even if they can't afford a new study on top of everything right now... and don't want to put any energy towrads it ... at least be smart enough to create an empty campaign fund... maybe that has no chance of even going anywhere... and if the patients can by a stroke of luck manage to raise the money themselves, it at least happens.... at least make it look like you are listening. (or do a "portion of these proceeds" campaign, and just make the percentage up arbitrarily)

 

[Cort]

Money might be one issue. But again, I see serious issues with their attempts at creating additional funding streams. MS gets money because of the PR. If they wanted better funding, they should be doing better PR.

I've pointed out just one of the issues I have with their PR.... but its really a systemic approach with them.... for instance a lot patients aren't really happy with their reserach funding. Its hard to convince the government to study retroviruses when the largest cfids non profit group doesn't put any money towards them. So, they need to start looking at their research budget as part of their pr....

even if they can't afford a new study on top of everything right now... and don't want to put any energy towrads it ... at least be smart enough to create an empty campaign fund... maybe that has no chance of even going anywhere... and if the patients can by a stroke of luck manage to raise the money themselves, it at least happens.... at least make it look like you are listening.

Its hard to convince the government to study retroviruses when the largest cfids non profit group doesn't put any money towards them. So, they need to start looking at their research budget as part of their pr....

I think they are doing that are they not? The CAA hasn't funded a research project for several years now. Their last funding opportunities occurred before XMRV came onto the scene. Now there is this perception -which has come up twice in this thread - that the CAA is not putting money towards XMRV yet it should be clear that the CAA is one of only two CFS support organizations (Invest in ME is the other, I think) that is actually funding a XMRV research study.

Again - the CAA's first Biobank project is a research study using a very rigorous (and WPI-like) cohort with Glaxo-Smith Kline - to look for XMRV. (It doesn't seem to have helped their PR much yet - at least in the Forums )

 

[judderwocky]

I think they are doing that are they not? The CAA hasn't funded a research project for several years now. Their last funding opportunities occurred before XMRV came onto the scene. Now there is this perception -which has come up twice in this thread - that the CAA is not putting money towards XMRV yet it should be clear that the CAA is one of only two CFS support organizations (Invest in ME is the other, I think) that is actually funding a XMRV research study.

Again - the CAA's first Biobank project is a research study using a very rigorous (and WPI-like) cohort with Glaxo-Smith Kline - to look for XMRV. (It doesn't seem to have helped their PR much )

Right. But how many years have they suspected retroviruses were at work here? The issues is that they started that AFTER the WPI did....(and they obviously saw that there were reasons to look there) I might have not had CFIDS then, but I have seen the documentaries... some as late as 96 that showed high level CDC officials saying "its probably a retrovirus, that would be what i would think".... people are taking issue with the fact that they still aren't putting money towards it...

can you go into a little detail about how they are funding it but not putting any money towards it? i didn't notice any studies listed in their six funded studies... am i looking in the wrong place? i mean it looks like this study is just the pharm companies looking through the bio bank samples.... are they actually allocating or putting any money towards future studies that they fund??? pharmaceutical interest is nice... but i don't completely trust it...
it still doesn't look like they had to fund this study with the pharm companies... am i wrong? did it require any capital interest on their part?
i get that they are "interested" in xmrv... they do webinars on it, they make little statements occasionally congratulating people... what i think people want to see is them actually put their WEIGHT behind it.