Suzanne Vernon: "Agency heads are scared to death...if XMRV works out"

[Sean]

There is a political campaign going on right now in Britain to further limit access to sickness benefits.
The new legislation has been written to try to specifically exclude those with "unexplained" medical conditions like ME/CFS.

Yes, it is all very nasty stuff indeed. I am afraid UK patients are in for an even rougher ride in the near future.

Hope certain researchers and clinicians are proud of the part they had in creating this outcome.

 

[garcia]

Yes, I agree with you Alex. I think having BOTH the WPI and CAA working on research is great. Starting a premiere advocacy and PR organization to help them and the greater patient community would also be great.

It depends if its going to be another CAA that just sells us down the river, then that is something we don't need!

 

[CBS]

The original comment was “Agency heads are scared to death of how the patient population will react if XMRV works out.”

I think you can substitute the pathogen "XMRV" with just about anything and come to the same conclusions.

Agency heads and some "advocacy" organizations are scared to death that CFS patients will have the evidence that they've been sold down the road. XMRV would have been the smoking gun. I'm quite sure that it isn't the only smoking gun out there.

"Agency heads" and others are "sacred to death" that they've screwed up. There would be nothing to fear if they were absolutely positive that this whole thing was just a bunch of "patients" - or at the very least they had done their best and treated the patients with respect (neither of which has happened) and they seem to be praying that they won't be held accountable and that their malfeasance does not come to light on their watch.

 

[citybug]

I think agency heads should be scared now. We are angry now. The only and easiest thing for them to do is to give the grants for xmrv research. If they just turned around and started working on it, since now there is a solid foundation for research, what could anyone say? XMRv was discovered in 2006.
Just in case any of them are reading here. Start the research or take your retirement.

 

[markmc20001]

My opinion is that there has never been much doubt about the reality of ME/CFS in the minds of health chiefs.
The governments of Britain and the US have been working hand in hand with business to "manage" health costs.

The whole psychiatric "debate" has just been encouraged by the state in order to provide a plausible cover for their refusal to meet the expense of our disability - I think the psychiatric debate on ME completely futile.

Most sufferers are young adults and have their working lives ahead of them. No insurer wants to pay disability insurance out for twenty years -widespread chronic illness in people of working age would drastically eat into their future profits.
The reason they are scared to death of the patient reaction if XMRV works out is because they know they have allowed vested interests to deliberately frustrate research in this field for over thirty years to cut health costs - insurance companies in the US and the government protecting the social security bill in Britain.

In the last twenty years I have watched the illness affect younger age groups - in my generation it was usually adults affected but increasingly I saw children go down with ME.

The calculated risk they took was that this disease was not transmissible and that they could safely ignore us and any cost we presented to the state.
If XMRV works out it is transmissible and what is more is could be passing down in families. Rather than protecting our health they have been cynically belittling us, have made us live with the terrible stigma of not having our illness recognised, while allowing this disease to spread.

Even now they do not wish to face the possibility of XMRV being the cause- because it will cost too much money to put right. They would rather leave the problem to their sucessors and avoid accountability themselves.

There is a political campaign going on right now in Britain to further limit access to sickness benefits.
The new legislation has been written to try to specifically exclude those with "unexplained" and fluctuating medical conditions like ME/CFS. Our patient organisations are trying to get the legislation changed to be more fair to patients, but the government's motives are nakedly revealed as inhumane, driven by greed, and abusive of the chronically sick. It is known that there are at least 250 thousand CFS/ME sufferers in Britain. Think of what we must cost the state and how tempting it must be to introduce legislation to limit our right to benefit. After all we are not going to embarrass the government by dying from our illness so it is an easy one to deny. The longer CFS/ME remains "unexplained" the cheaper for the welfare bill.
The timing of the release of the PACE trial results and massive publicity subsequently given to them was carefully planned to coincide with this latest attack on sickness benefit and those with long term conditions.

The last thing they want to do is recognise ME/CFS as a real illness and XMRV as its cause.
I am actually really interested to see what happens next because there will be a real battle.

I agree with most of your logic Currer. All up to the point that the CDC "took a gamble" that XRMV was not transmissable. That I do not agree with. Considering the CDC is a fedrally funded agency with probably an unlimited federally funded budgets. I find it hard to believe they just "take a gamble". They are scientists. Scientist work with proof to come to scientific conclusions.

My logic leads me to believe the CDC did all the research and understood completely what XRMV was back into the 1980's, or before. They just haven't admmitted to it. They probably understood that back around the time Dr Lo's mycoplasma patent for biological warfare was granted...

If people here agree that the CDC wouldn't "take a gamble" then one would have to ask. Why would the CDC knowingly allow a retrovirus to run through the population??

This is where everybody's mind locks up becasue it is too hard to imagine that our sweet heart government would harm people(the same government that had been actively doing sick research up in to the 1970's on people all over the world without consent. prisoners, hepatitus, syphylus, other unknowing countries, ....).

The fact scientist must come to scientific conclusions, is why people here have their panties in such a bunch over not getting consistant confirmation over the WPI results. Because the CDC won't acknowledge the science!! THE CDC KNOW'S THIS. They keep releasing dried blood spot stff, or use the wrong primers.

IT IS THE CDC'S LEVERAGE ON THE COMMUNITY to not verifying the WPI results. Plausable deniability....their game back in to the 1980's.

THE FDA ALREADY VERIFIED THE WPI'S FINDINGS, with more advanced testing methods to boot! I'm sure these retrovirus testing methods have all advanced tremendously since the late 1970's when retroviruses became the rage during the AIDS outbreaks and research.

It's difficult to get ones mind around, but the CDC purposely let XMRV run wild in the population... Yep I said it.... How can there be any other logically outcome? Does anybody really believe the CDC "took a gamble"????????? They have been churning out science since the 1980's on this stuff.

It's the CDC(and UK) who have confused everybody with their public Psych-ops/psychobabble campaign to make it seem like we all have depression. They have confused everybody with the bogus dry blood spot studies, and "might be contamination" studies.

NONE OF THIS IS AN ACCIDENT. It is a calculated and deliberate campaign that has been going on since the 1980's. Scientist don't make mistakes. They check their work, many times over. Not many can wrap their minds around it being deliberate? Then one would have to come to the conclusion that people are not nice and are lying to us?


think our governments areb't capable of doing harm back in the 1970's? read this...

http://www.southbendtribune.com/article/20110228/News03/102280315/1130

 

[Cort]

“Agency heads are scared to death of how the patient population will react if XMRV works out.” - Suzanne Vernon, September 11th, Lobby of the Salt Lake City Downtown Hilton – During a break at the 2010 OFFER Utah Patient Education Conference

I’ve been struggling with what I ought to do with this for almost six months. Suzanne Vernon said this during a conversation she was having with me and Cort. She just sort of interjected it. No real need nor was there much of a segue. She said that it should not be repeated. Yet I wondered why I earth she would say something like that to someone she had just met.

I was troubled by Dr. Vernon’s words. I wished I had not heard it. I discussed the comment at length with my wife. I’ve asked Cort about it on a couple of occasions. He responded that he does not recall having heard her say it. And so I approached Jennie Spotila and I asked her what Dr. Vernon might have meant. That conversation took place on December 10, 2010. Jennie said she would check with Dr. Vernon and get back to me. I haven’t heard back from Jennie on this topic and so I’m assuming that there won’t be a reply. Why can’t this be shared with the patient community? Who am I protecting and who is being harmed? I have not felt that it was right to keep this from the patient community.

I was reading Hillary Johnson's recent post about “FRENEMIES”. Hillary stated ” Whatever these two [Suzanne Vernon and Kim McCleary] tell you they’re doing, you can assume it’s about one-twentieth of what they’re doing behind the scenes and, given the lessons of history, you can bet it’s not on your behalf.” I was reminded of Dr. Vernon’s comments.

And what about Hillary's comment about Kim McCleary's inside voice:

I’m quite sure from the CAA’s actions and public statements that they do not share my sense of urgency or appreciation of the severity of ME. I’ve come to feel that not sharing Dr. Vernon’s comment is keeping a secret that can only perpetuate the harm being done to all ME patients.

Besides the fact that you're breaking confidence with Dr. Vernon... I don't understand what the big deal is. Isn't that what you would think they would think? Of course agency heads are concerned about an outcry. There are plenty of things to take the CAA to task for. Their advocacy can be inept at times - but that's as far as I go. To suggest they are trying to undermine XMRV or the search for pathogens is beyond the pale for me.

Vernon Conversation - I was there for the hour or so conversation we had with Dr. Vernon and I don't remember that comment at all - which doesn't mean much. I assume it was said - it 'means it simply it didn't stick in my mind at all - no flares went off. I remember other things about that conversation. I remember Dr. Vernon shedding some possible cause on CBS's infectious onset that he hadn't heard before. I remember her talking about how Dr. Lipkin has believed CFS was caused by a virus for many years. I remember her calling him "Ian" and mentioning that she spoke to him. I just don't remember that comment...

It obviously bothered CBS quite a bit. He asked me about it several times and went so far as to ask Jennnie Spotila about it....we obviously had a very different interpretation of what it meant.

I suppose the implication is that the CAA is somehow sabotaging XMRV....I actually don't have to suppose that's - CBS's post clearly proposes that the CAA is working to do that. Apparently enrolling an drug company that produces antivirals - Glaxos Smith Kline - and has everything to gain by finding the virus - to study XMRV in a CAA study - is this part of the conspiracy as well?

Lipkin - Then there's the Lipkin connection. In our conversation Dr. Vernon noted that Dr. Lipkin - whom she knows - has believed CFS may be caused by a virus for 20 years. Not long after our conversation the CFIDS Association was able to convince Dr. Lipkin to be nominated for a 4 year stint on the CFSAC panel. Then Dr. Lipkin was announced to head up the 1.3 million dollar NIH study on XMRV. This too is part of the XMRV undermining?

(Was the CAA's nomination of Dr. Peterson, Annette Whittemore and Dr. Mikovits to the prior panel more of the conspiracy?)

Singh - The CAA were also able to convince XMRV expert Dr. Singh - whom CBS knows - to agree to be on the CFSAC panel. These are deep moles indeed. On the surface GSK, Lipkin and Singh have everything to gain from finding XMRV and they appear to be working to do it. Unfortunately they are also quite connected with the CAA and since that organization clearly does not want XMRV to work out - based on CBS's implications - we must assume they are part of the underground movement.

The Email! - Then there's that horrific email. My god - what a thing. The CAA was not following the European's orgs lead on petitioning the government. Can I ask what happened at that meeting? Did the FDA actually call for a 'ban' on blood donations from CFS patients?

We are making much ado about the CAA not joining a petition? (and how helpful have those been in the past?) And totally disregarding their very public demands that a blood donation's be stopped? And well as the fact that the issue was resolved to many peoples satisfaction without a petition; ie maybe one actually was not needed?

To me all of this is much ado about nothing. If the CAA had not pressed for a ban on blood donations....or if they had not gotten an XMRV study going...or if they had elected some flunkies to the CFSAC panel instead two of the top virologists and XMRV experts in the country........That would have called for outcries.

but a single line in a conversation - that simply said it like it was.....an email that had no bearing on how the situation turned out ...that is what we focus on? I'd rather focus on what the CAA does and doesn't do...They screwed up the PACE response - ...I say go after them on that - that's appropriate - not these little quotes. To argue that they are screwing up in advocacy is one thing...to suggest they are trying to undermine your and my interests is quite another.

Record - What record? - Dr. Yes and Justin yesterday dug up some quote from Dr Vernon 5 years ago that bothered them... Nothing in Dr. Vernon's activity at the CAA over the past five years has indicated any reason for concern about that issue. They know that! Her record was posted in the very article they posted on - it indicated there is no reason for concern about that issue.....she is not interested in it...she is not pursuing it...she is pursuing very different types of research - types of research they very likely really applaud...but that doesn't figure into their calculations - I think its the strangest thing.

 

[Cort]

Then why the need for secrecy? What's being said behind closed doors with those inside voices? My concern is the apparent duplicity. The CAA's "gaffs" are far too consistent. They ought to be taken at face value and as a measure of where they actually stand on issues.

Do you mean their reports on the PACE trial

http://www.cfids.org/cfidslink/2011/lancet-study.asp

The study reported modest benefits following a six-month course of cognitive behavioral therapy (CBT) or graded exercise therapy (GET) compared to specialized medical care alone or adaptive pacing therapy, based on improvement in self-reported symptom scores.

News stories have touted more conclusive results than the data support. The authors conclude in the paper, “Our finding that studied treatments were only moderately effective also suggests research into more effective treatments is needed.” However, the public will likely only read headlines like this one, “Talking and exercise could cure M.E. – study.” Such tidy conclusions are dangerous. They contribute to dismissive attitudes about CFS and undermine understanding of its severe and life-altering impact.

Maybe its this one. I'm not saying this is like fun reading but it does get the point across - if you care to read it. May provide modest benefits but no more so than in other chronic illnesses (ie CFS is not a behavioral disorder - if you don't feel like reading between the lines).

Structured programs that seek to expand function and reduce symptoms may provide modest benefits when added to standard medical care, but they do not offer complete resolution of symptoms or cure, and the benefits are equivalent to those seen in other studies of chronic illness. Younger, less severely ill and more recently ill individuals may benefit more,

I get it - they didn't have the kind of responses you or I wanted. It should have been a bolder response...but it's not like they were saying take CBT/GET and get well from CFS.

While the authors state that the funding agencies had no role in the study design or conduct, it is difficult to ignore the U.K. government’s strong stake in a good outcome. In essence, it was too big to fail to reinforce existing U.K. policy that favors provision of psychological approaches over medical ones.

It appears to me that their stand on the PACE trial is that it provided only modest benefits, probably mostly to the young and less severely ill, and provided no more benefits than it would for any other chronic illness - which means of course that CFS is not a behavioral disorder; its a chronic illness like any other chronic illness.

I get that their presentation was pretty piss pour- but I don't have a problem with where they stand. I think its pretty clear. I could have taken the data in their analyses and smacked the PACE trial in the face with it. I would have used bolder language, I would have re-organized it, etc. and it would have been quite effective I think. The point is that many of the points everybody is talking about (not all of them but many) were there.

So where do you think they stand on PACE?

 

[markmc20001]

me who suggested conspiracy

I'll take credit for interjecting the conspiracy comment linking the CAA to part of some conspiracy. I question everybody's motives at this point.

I think the distrust of the CAA comes from the history of the CAA. The CAA is repsonsible for derailing Elaine Defreitas's career in the 90's after publishing retrovirus research and writing a book. It is very disturbing the CAA derailed Elaine Defreitas effort to reveal a virus back then. It certainly bothers me alot since I have no idea of how the CAA was founded, what their budget has been, how they spend that money, and who has funded them.

This is why the CAA bothers me. I'm sure there is a long list of other complaints too.

 

[Cort]

Originally Posted by CBS
Then why the need for secrecy? What's being said behind closed doors with those inside voices? My concern is the apparent duplicity. The CAA's "gaffs" are far too consistent. They ought to be taken at face value and as a measure of where they actually stand on issues.

Where else did the CAA stand on this issue?

They noted that some people may have been excluded from the trials because of neurological and cardiovascular symptoms; ie the trial might not have reflected the average CFS patients and certainly may not apply to people with neurological and cardiovascular symptoms - something they note that the UK Health service itself has noted.

http://www.cfids.org/pdf/lancet-analysis.pdf

There are no data in the paper indicating how many subjects might have been excluded on the basis of neurologic or cardiovascular signs or symptoms. The National Health Service guidelines for CFS state that the presence of these symptoms warrants further investigation and consideration of alternate diagnoses.

They also felt it was important to note that many patients who were too ill were unable to participate in the trials - and thus it did not apply to severely patients.

It is important to note that study participants had to be able to attend sessions at a hospital or clinic, and therefore more severely ill or homebound patients were not included.

Despite the size of the study they pointed out that most CBT trials now attempt to look a biological effects of the treatments and this one did not...which brings into question why not?

Studies of CBT in other conditions including HIV/AIDS and cardiovascular disease, routinely collect data on immune markers or other biological measures in attempt to understand how and why CBT works in the context of the condition studied.

Possibly because studies in other diseases show that CBT can be helpful in reducing inflammation and immune activity. The CAA suggests that if the PACE trial had done this they would simply have shown that CBT simply does in CFS as it does in other diseases - it reduces some immune activation

,

it is deeply disappointing that there was no attempt to include measures that might provide a biologic explanation for the outcomes reported. In fact, the word biology is not mentioned once in this paper. The lack of biological explanation for observed improvements reinforces the perception that CFS is mind over matter, even while the paper says it should not.

The CAA reinforces the fact that the PACE trial was probably simply doing what all CBT trials so - putting CFS squarely in the context of other legitimate disorders.

While most people recognize that CBT and GET can be effective in many chronically ill populations as an adjunct to medical care, the news coverage of studies like this one often fails to underscore this point. In several studies of CBT and infection, CBT is shown to work by helping decrease chronic inflammation and tempering the number and activity of harmful immune cell activity

 

[CBS]

So where do you think they stand on PACE?

There's often a striking difference between what comes out of the CAA in comments to media and what they post on their web-page.

I read that what you posted from the CAA page on February 21st, three days after the "gee I wish 'our' patients had better access to CBT and GET" comment had been splashed all over the world's news.

No one sees their web-page and no one is going to do a story or a correction based upon it. Why does the first thing out of their mouths (and the only thing the rest of the world hears) sound so limp wristed then days later there's a pdf on their web-page that is primarily for patient consumption that is supposed to make it all better.

They're horrible at the advocacy game and getting paid a lot of money (in my opinion an unjustifiable amount regardless of what I hear from the CAAs board, which just makes the board look bad) for an organization that does not seem to appreciate that advocates don't get a chance to keep coming back and fine tuning their original message. And why is it so hard for them to get the original message right? Who are they trying to please or are they really that confused about the patients they are supposed to be representing?


ETA:
Could the CAA give a two sentence description of "CFS" that captures the experience of the most severely ill ME patients? I doubt they could do it, stand behind it and not qualify it until their original two sentences were completely meaningless.

 

[Cort]

Finally - medical care for people with CFS simply sucks and much more work is needed to find a way to treat CFS.

The takeaway message from this study is that the current standard medical care available to people with CFS (by any definition) remains very limited and is relatively ineffective on its own.

So where does the CAA stand on the PACE trial

• not very effective
• when it is effective it's probably usually effective for younger, more severely ill patients
• may have excluded people with significant neurological and cardiovascular symptoms
• definitely excluded more severely ill patients
• therapies work no different in CFS than in other disorders
• study was too big for the UK govt to allow to fail
• study failed to provide measures of functionality (ie walking)
• if they had taken biological measures they would have seen CBT works in CFS just as it does in other diseases
• the standard medical toolkit is limited and ineffective - more research and better treatment option are needed (ie CBT/GET is not enough)

Their Duplicity - Now that we know their stand on the PACE trial we can figure out who they are being duplicitous with. Their stand must an indication of their duplicity.....this is tough!!!....because I don't think White or Wessely or the UK government is going to march in lockstep with an analysis that CBT is not very effective and then only in some patients.

Maybe its the insurance companies as Justin suggested......but the fact that they call CBT/GET pretty ineffective isn't going to wash well there and they do say medical care for CFS really sucks - which does kind of indicate that more research should be done -and who knows where that will lead. Then they are doing the XMRV study with GSK and GSK certainly wants to find that virus...think what a best seller their next drug would be and what a horror for the insurance companies. So they're not in lockstep with the insurance companies.

They seem to be aligning themselves with a group of people who believe behavioral therapies like CBT/GET are probably only somewhat effective in younger, less severely affected patients, who think we've just got to pursue better treatments and more research because the options are so limited right now.....

who are those people??? ahh, slap on the forehead....it's the patients!

 

[Cort]

There's often a striking difference between what comes out of the CAA in comments to media and what they post on their web-page.

I read that what you posted from the CAA page on February 21st, three days after the "gee I wish 'our' patients had better access to CBT and GET" comment had been splashed all over the world's news.

No one sees their web-page and no one is going to do a story or a correction based upon it. Why does the first thing out of their mouths (and the only thing the rest of the world hears) sound so limp wristed then days later there's a pdf on their web-page that is primarily for patient consumption that is supposed to make it all better.

They're horrible at the advocacy game and getting paid a lot of money (in my opinion an unjustifiable amount regardless of what I hear from the CAAs board, which just makes the board look bad) for an organization that does not seem to appreciate that advocates don't get a chance to keep coming back and fine tuning their original message. And why is it so hard for them to get the original message right? Who are they trying to please or are they really that confused about the patients they are supposed to be representing?

Could the CAA give a two sentence description of "CFS" that captures the experience of the most severely ill ME patients. I doubt they could do it, stand behind it and not qualify it until their original two sentences were completely meaningless.

So the CAA is duplicitous based on comments in the media - comments that we know only present a partial picture of what representatives of the CAA or any other person being interviewed by the media says... You're also suggesting that the CAA is working in an underhanded fashion to undermine our interests (aka the Hilary Johnson quote) because they produce muddled documents that aren't very effective in getting their point across? Did I get that right?

(You can see how tweaked I was by those original comments! )

I get how disappointing they are to you (and many others and at times to me) but I think a simpler and more accurate explanation is that they're just not very effective in that arena and they need to improve.

 

[CBS]

So you're calling the CAA duplicitous based on comments in the media - comments that we know only present a partial picture of what representatives of the CAA or any other person being interviewed by the media says... You're also suggesting that the CAA is working in an underhanded fashion to undermine our interests (aka the Hilary Johnson quote) because they produce muddled documents that aren't very effective in getting their point across? Did I get that right?

I get how disappointing they are to you (and many others and at times to me) but I think a simpler and more accurate explanation is that they're just not very effective in that arena and they need to improve.

I'm suggesting that repeatedly representing only part of the picture to the media raises questions about what they are saying behind the scenes.

I don't know what they are saying behind the scenes. I do not recognize the disease I am fighting in their public pronouncements and they have lost my trust.

 

[Cort]

From the CAA - CFS will be featured tonight on “The CBS Evening News with Katie Couric.” The report will focus on a new research study on biological markers identified in the spinal fluid of CFS patients. The study is embargoed until 5:00 p.m. We will send an analysis and links to CFIDSLink subscribers at 5:00. Note: Writing to CBS and Couric about the PACE study may only serve to shift the focus away from the exciting new report.

Dr. Yes - After the total fiasco that was McCleary and the CAA's response to the PACE trial, they now want patients to stop writing in to educate Couric and CBS on the PACE study - which will doubtless be covered in the news story, and we've seen how well media coverage of THAT has gone - because it will distract from a study that the CAA tells us from their inside info will be covered, but which is embargoed until just before the news broadcast.

The PACE trial was not covered in the show...

Dr. Yes - Odd that a study that sounds like another investigation along the lines of Baraniuk's work on evidence for neuroinflammation in CSF from CFS patients would be rushed to the evening news and actually be the focus of this story, according to the CAA, as opposed to the incredibly controversial PACE study that was recently published. And XMRV, so far, does not seem to be a focus at all, despite frankly being a potentially far more significant area of research than another study on evidence of neuroinflammation.

You would really rather them focus on XRMV (and contamination - because that is the issue right now with XMRV - and that is what they will cover)? I wouldn't! I'd rather them focus on some new juicy completely positive research on CFS.

It was odd that CBS covered that study. Absolutely it was - but in a bad way? (Are you trying to turn lemonade into lemons?). My guess is that we have a very good friend high up in CBS who wanted a counter to the negative news of the PACE trial. When was the last time CFS was a subject of a Katie Couric spot? This only happened because PACE was big news and they were trying to counteract it.

Even if one says that, well, it's a good thing that at least they cover THAT, there is no question that they will also cover PACE, which makes patient input to CBS (the TV company, not Shane) essential. So was this just another gaffe by the CAA, with no connection to their pseudo-endorsement of the therapies used in the PACE trial, or was it a moment of paternalism towards the patient population, or was it more? I don't know but, like Shane and others, I'm having a hard time not seeing something more than incompetence running through the CAA's actions.

Honestly I think trying to get CBS to cover PACE and the Spinal Fluid study - when CBS (not the person) is clearly focused on the one - and will spend a limited amount of time on that one - is not a very 'competent', shall we say, idea. I think the CAA probably did the right thing - they knew what the story was going to be on since CBS (the station not the person) contacted them beforehand.

Then they encouraged the CFS community to pump up the story that was being presented (not the story was not being presented). Not a gaffe at all - just smart thinking.....

ETA - Thankfully, either the rumors that CBS would cover PACE were wrong or patient pressure made a difference (I suspect the former)! However, the point remains that patients should not have been asked not to send in comments.

Do you think the patients put pressure on CBS to not cover the PACE trial? I think they put pressure on them to cover it properly......Now, after you've taken the CAA to task for asking patients to focus on the spinal fluid study (and not cover the PACE trial) - you're apparently happy that the PACE trial was not part of the story. My head is spinning....

The point for me is that the CAA did the strategic and smart thing.

 

[justinreilly]

In our conversation Dr. Vernon noted that Dr. Lipkin - whom she knows - has believed CFS may be caused by a virus for 20 years.

That's great news.

The Email! - Then there's that horrific email. My god - what a thing. The CAA was not following the European's orgs lead on a petition and they were waiting for the result of the BWG. (Well - shoot 'em!). Can I ask what happened at that meeting? Did the BWG actually call for a 'ban' on blood donations from CFS patients? Didn't the CAA prior to that in numerous instances - do the same?

We are making much ado about the CAA not joining a petition? (and how helpful have those been in the past?) And totally disregarding their very public demands that a blood donation's be stopped? And well as the fact that the issue was resolved to many peoples satisfaction without a petition; ie maybe one actually was not needed?

To me all of this is much ado about nothing. If the CAA had not pressed for a ban on blood donations....or if they had not gotten an XMRV study going...or if they had elected some flunkies to the CFSAC panel instead two of the top virologists and XMRV experts in the country........That would have called for outcries.

but a single line in a conversation - that simply said it like it was.....an email that had no bearing on how the situation turned out ...that is what we focus on? I'd rather focus on what the CAA does and doesn't do...They screwed up the PACE response - ...I say go after them on that - that's appropriate - not these little quotes. To argue that they are screwing up in advocacy is one thing...to suggest they are trying to undermine your and my interests is quite another.

The reason I think this email is damning is the she is reporting to the Feds that CAA has been "resisting pressure" to recommend that blood donation by pwME be banned is because
(1) there should be no question by CAA that blood donation should be banned because (a) it endangers the health of the pwME donor (b) XMRV and many other pathogens and suspected pathogens are highly associated with ME and (c) even if these pathogens do not cause ME, it is most likely some other undiscovered virus causes it and (d) the association of ME with cancer;
(2) it sounds like McCleary is taking the attitude that she works for HHS and is reporting that she is resisting outside pressure from patients. She should be resisting pressure from CDC not patients for whom she works!

Record - What record? - Dr. Yes and Justin yesterday dug up some quote from Dr Vernon 5 years ago that bothered them... Nothing in Dr. Vernon's activity at the CAA over the past five years has indicated any reason for concern about that issue. They know that! Her record was posted in the very article they posted on - it indicated there is no reason for concern about that issue.....she is not interested in it...she is not pursuing it...she is pursuing very different types of research - types of research they very likely really applaud...but that doesn't figure into their calculations - I think its the strangest thing.

You are right. I am simply saying she should be actively pushing our messages in the media, as she showed she was able to do in that article. She was involved in the Reeves criteria, it is an absolute travesty and since she is working for us she should go beyond making a statement buried somewhere on the CAA website.

CBS makes what is my central point. it is insufficient to put an acceptable statement somewhere on an inner page of the website, while saying the wrong thing to the media- which is pretty much all that people ever hear.

 

[justinreilly]

Cort, some of these posts have the sarcastic tone that you would threaten others with banning from the forums if others displayed it. It's getting old for me to be bringing this up with you. Either allow others to do it, don't do it yourself or do not post on PR.

 

[Cort]

T

The reason I think this email is damning is the she is reporting to the Feds that CAA has been "resisting pressure" to recommend that blood donation by pwME be banned is because
(1) there should be no question by CAA that blood donation should be banned because (a) it endangers the health of the pwME donor (b) XMRV and many other pathogens and suspected pathogens are highly associated with ME and (c) even if these pathogens do not cause ME, it is most likely some other undiscovered virus causes it and (d) the association of ME with cancer;
(2) it sounds like McCleary is taking the attitude that she works for HHS and is reporting that she is resisting outside pressure from patients. She should be resisting pressure from CDC not patients for whom she works!

That's not how I read it at all. .Here's one statement from the CAA on their FAQ page on Blood donations. As you can see CAA's reps were part of that group and they were pushing the group internally to produce a blood ban and the group did do that.

Is the Association advocating for testing of the blood supply for XMRV?
Yes. Suzanne Vernon, PhD, our scientific director, is a member of the Department of Health and Human Services Blood XMRV Scientific Research Working Group. CEO Kim McCleary serves on the AABB (formerly the American Association of Blood Banking) Interorganizational Task Force on XMRV. Read more about the HHS-led efforts. Confidentiality agreements signed as a condition of service on these committees preclude us from providing regular updates, but meaningful progress is being made and a report is anticipated at the upcoming CFS Advisory Committee meeting on May 10, 2010.

That committee recommended that blood donations from CFS patients be deferred. On June 10th the AABB made the same recommendation

http://www.cfids.org/xmrv/aabb-statement-june10.asp

Here's Kim McCleary's testimony on Dec 10th to the FDA Blood Advisory products Committee. In it she describes a survey the CAA put on earlier in the year to determine how many people with CFS have given blood. They did that in order to give them more push with the very government agencies you just asserted they were assisting.

If you want to find out more about the CAA's role in the blood donation question check out the URL below. You'll find that contrary to Hillary Johnson's assertion they were actually far more active than any other organization in pushing for a blood ban. A balanced view of the subject would have looked at all their activities and noted which were positive and which could have been done better - but that's not Hillary Johnson does...

http://www.cfids.org/blood.asp

You are right. I am simply saying she should be actively pushing our messages in the media, as she showed she was able to do in that article. She was involved in the Reeves criteria, it is an absolute travesty and since she is working for us she should go beyond making a statement buried somewhere on the CAA website.

You wonder why I get sarcastic sometimes....Its not buried somewhere on the website. It's on the frequently asked questions page on the website - one of the main links on the website.

CBS makes what is my central point. it is insufficient to put an acceptable statement somewhere on an inner page of the website, while saying the wrong thing to the media- which is pretty much all that people ever hear.

The point CBS makes is that if you make a bunch of statements to the media and the media happens to choose a not very powerful one and doesn't use the others then CBS is going to assume that they didn't make those other statements. I don't that's accurate or fair.

An no - it doesn't take much digging to find that information - it just takes some digging.

I'll try and cut down the sarcasm - I realize it just ticks people off.

 

[CBS]

The point CBS makes is that if you make a bunch of statements to the media and the media happens to choose a not very powerful one and doesn't use the others then CBS is going to assume that they didn't make those other statements. I don't that's accurate or fair.

My point was that making any weak statements to the media when you are representing this disease, can at best be interpreted as being clueless about how the media and advocacy works (strong statements do not require overstating what is known) and at worst raises questions about the possibility that the weak statements were included to appease parties other than the patients the CAA is supposed to be representing.

I refuse to to accept the argument that in KM's case $170K doesn't buy you much. I'm just starting to wonder about who's buying it because who ever it is seems perfectly satisfied so far.

 

[SilverbladeTE]

Cort
GlaxoSMithKline's VASTLY imbedded with the plutocracy that runs the UK.

1) As noted in the Wakefield mess, the guy who runs the company who owns The Lancet, was the brother of the judge who turned down Wakefield's appeal (judge didn't recuse himself which is seriously wrong). The brother is also, tada, a GSK exec!
http://en.wikipedia.org/wiki/Crispin_Davis
http://www.notablebiographies.com/newsmakers2/2004-A-Di/Davis-Crispin.html
http://www.powerbase.info/index.php/Nigel_Davis


2) Rupet Murdoch's son is on the GSK board, and las I heard osme years ago, Murdoch's empire owned 300 million of GSK shares.
http://www.forbes.com/2009/02/03/gl...rkets-equity-0203_drugmakers-appointment.html

3) GSK has been dragged through wrogner for REPEATED vile crap about pharma drugs...go read up on it, it's a LOT.

http://crime.about.com/od/news/a/bldog_glaxo.htm

http://www.miamibeachinjurylawnews....rimes-miami-can-we-blindly-trust-the-dru.html

http://crimereportusa.com/cru/2010/...ty-in-puerto-rican-adulterated-drugs-cas.html

lot smore if you go dig.

Sep 20 2005
GlaxoSmithKline has paid over $150 million to resolve allegations that the company violated the False Claims Act through fraudulent drug pricing and marketing of two anti-emetic drugs, Zofran and Kytril, used primarily in conjunction with oncology and radiation treatment, the Justice Department announced.
The United States alleged in settlement documents that GlaxoSmithKline - one of the world's largest pharmaceutical manufacturers - engaged in a scheme to set and maintain fraudulent and inflated prices for Zofran and Kytril knowing that federal healthcare programs established reimbursement rates based on those prices.

GlaxoSmithKline Lawyer Lauren Stevens Charged With Federal Crimes: Miami, Can We Blindly Trust the Drugs We Take?
November 11, 2010
Posted In: Defective Products (Product Liability) , Life on Miami Beach , Medical Malpractice , Pharmaceuticals , Safety

By Bryant Esquenazi on November 11, 2010 1:01 PM | Permalink | Comments (0) | Share The blind trust in prescription drugs (and OTC medicines) that we here in Miami Beach as well as elsewhere across the country have may be very much misplaced, and the more lawsuits that are filed, the more obvious the scullduggery appears to be.

Last week, we were pondering the number of cases filed by former drug company employees, whistleblowing about the bad stuff they were seeing happening regarding both prescription drugs as well as over the counter medicines. Part of that involved GlaxoSmithKline admitting guilt to a crime and paying over $750,000,000 in settlement of both criminal and civil claims against it.

Miami and the Nation - We Are All So Dependent Upon the Integrity of Doctors and Drug Companies

Drugs that we take, and give our loved ones, we're thinking that doctors know best and that these medicines will help them get better, and have less pain as they recover. We're all so dependent upon the kindness (and integrity) of strangers here, aren't we?

Well, now there's a new battlefield in the war against dishonest drug companies as the federal government has brought a criminal action against Lauren Stevens, 60, in-house attorney for Glaxo Smith Kline. (Read the complete news release by the Justice Department here.) According to the New York Times, filing criminal charges against Ms. Stevens is part of the federal government's "long-promised crackdown" on pharmaceutical company executives.

Glaxo Smith Kline's lawyer has been charged by the Department of Justice with:

•one (1) count of obstructing an official proceeding
•one (1) count of concealing and falsifying documents to influence a federal agency and
•four (4) counts of making false statements to the Food and Drug Administration (FDA).
The first two charges each carry a maximum penalty of 20 years in prison. The four charges of making false statements each carry a maximum penalty of 5 years in prison.

Meanwhile, GlaxoSmithKilne wasn't named in the indictment and so far, hasn't been charged with a crime by the feds.

Do you use drugs made by GlaxoSmithKline? Odds are high that you do.

Curious about whether or not you or a loved one takes a drug or medicine manufactured by GlaxoSmithKline? Easy enough to check, just go down the list of drugs and vaccines they have listed on their web site. On there, you will see such well-known drug products as:

Advair

Amoxil

Avandia

Boniva

Dexedrine

Flonase

Lamictal

Paxil

Valtrex

Wellbrutin

Zantac

Miami - Be Safe and Be Careful

As always, please remember that if you have a gut instinct that something isn't right with a pill or capsule or syrup - call your doctor. (Don't just automatically stop taking the medication until you speak with a health care professional, however, because cold turkey might have its own damaging repercussions.)

If harm has occurred take care of it first - safety and security are number one. After that, consider calling a lawyer. It's becoming glaringly obvious that lawsuits and money damages are what these drug companies respect, not the basic concepts of doing the right thing because it's the right thing to do

GlaxoSmithKline Guilty in Puerto Rican Adulterated Drugs Case
Tuesday, October 26, 2010 at 6:57PM
GlaxoSmithKline to Plead Guilty and Pay $750 Million to Resolve Criminal and Civil Liability Regarding Manufacturing Deficiencies at Puerto Rico Plant

BOSTON—SB Pharmco Puerto Rico Inc., a subsidiary of GlaxoSmithKline, PLC (GSK), has agreed to plead guilty to charges relating to the manufacture and distribution of certain adulterated drugs made at GSK’s now-closed Cidra, Puerto Rico manufacturing facility, the Justice Department announced today. The resolution includes a criminal fine and forfeiture totaling $150 million and a civil settlement under the False Claims Act and related state claims for $600 million.

The drugs, manufactured at the plant between 2001 and 2005, are Kytril, Bactroban, Paxil CR, and Avandamet. Kytril is a sterile anti-nausea medication. Bactroban is a topical anti-infection ointment commonly used to treat skin infections. Paxil CR is the controlled release formulation of the popular anti-depressant drug, Paxil, and Avandamet is a combination Type II diabetes drug.

The Food, Drug and Cosmetic Act (FDCA) prohibits the introduction or delivery for introduction into interstate commerce of any drug that is adulterated. Under the FDCA, a drug is deemed adulterated if the methods used in, or the facilities or controls used for, its manufacturing, processing, packing, or holding did not conform to or were not operated or administered in conformity with current good manufacturing practice to assure that such drug met the requirements as to safety and had the identity and strength, and met the quality and purity characteristics, which it purported or was represented to possess.

The criminal information filed today alleges that SB Pharmco’s manufacturing operations failed to ensure that Kytril and Bactroban finished products were free of contamination from microorganisms. The criminal information further alleges that SB Pharmco’s manufacturing process caused Paxil CR two-layer tablets to split. The splitting, which the company itself called a “critical defect,” caused the potential distribution of tablets that did not have any therapeutic effect and tablets that did not contain any controlled release mechanism.

The criminal information also alleges that Avandamet tablets manufactured by SB Pharmco did not always have the Food and Drug Administration (FDA)-approved mix of active ingredients, and, as a result, potentially contained too much or too little of the ingredient with the therapeutic effect. Finally, the criminal information alleges that SB Pharmco’s Cidra facility suffered from longstanding problems of product mix-ups, which caused tablets of one drug type and strength to be commingled with tablets of another drug type and/or strength in the same bottle.

SB Pharmco has agreed to plead guilty to a criminal felony for releasing into interstate commerce adulterated Kytril, Bactroban, Paxil CR, and Avandamet, in violation of the FDCA. Under the plea agreement, the company will pay a criminal fine of $150 million, which includes forfeiting assets of $10 million. The guilty plea and sentence is not final until accepted by the U.S. District Court in Boston.

Under the civil settlement, GSK has agreed to pay an additional $600 million to the federal government and the states to resolve claims that it caused false claims to be submitted to government health care programs for certain quantities of adulterated Kytril, Bactroban, Paxil CR, and Avandamet. The United States contends that GSK sold certain batches, lots, or portions of lots of drugs, the strength of which differed materially from, or the purity or quality of which fell materially below, the strength, purity, or quality specified in the drugs’ FDA applications or related documents. GSK thereby knowingly caused false and/or fraudulent claims to be submitted to, or caused purchases by, Medicaid and the other federal health care programs.

The federal share of the civil settlement amount is $436,440,000, and GSK will pay up to $163,560,000 to states that participate in the agreement.

“Adulterated drugs undermine the integrity of the FDA’s approval process, can introduce substandard or ineffective drugs on to the market and, in the worst cases, can potentially put patients’ health at risk,” said Tony West, Assistant Attorney General for the Civil Division of the Department of Justice. “We will continue to work with our law enforcement partners to hold pharmaceutical companies accountable for this type of conduct and protect taxpayers from fraud, waste and abuse.”

“The industry has an obligation to ensure that all rules, regulations and laws are complied with,” said U.S. Attorney Carmen Ortiz. “To do less erodes public confidence and compromises patient safety. As this investigation demonstrates, we will not tolerate corporate attempts to profit at the expense of the ill and needy in our society—or those who cut corners that result in potentially dangerous consequences to consumers.”

“In fiscal year 2010, the Department of Health and Human Services, Office of the Inspector General (HHS-OIG) realized nearly $2.3 billion in settlements and judgments against the pharmaceutical industry,” said Daniel R. Levinson, Inspector General of the Department of Health and Human Services. “If all pharmaceutical manufacturers complied with the law, there would be no need for such massive settlements and judgments. But until they stop stealing from taxpayers and threatening the health and lives of Americans—as is alleged here today—HHS-OIG will continue to vigorously pursue these corporations and their executives.”

“FDA’s manufacturing standards are designed to ensure the safety and quality of drugs distributed to American consumers,” said Mark Dragonetti, Special Agent in Charge, FDA New York Field Office. “FDA expects pharmaceutical companies to abide by these manufacturing standards and correct deficiencies in an expedited manner. FDA and its law enforcement partners will continue to aggressively pursue those companies that place the public health at risk by distributing products that do not comply with all FDA requirements.”

“This settlement demonstrates that the government will not stand for sub-standard drug product. As a result of this extensive investigation, millions of dollars will be returned to the Department of Veterans Affairs’ Pharmaceutical Supply Fund for the direct benefit of our Nation’s veterans,” said Jeffrey G. Hughes, Special Agent in Charge, Office of Inspector General for the Department of Veterans Affairs.

“Federal employees deserve health care providers and suppliers, including drug manufacturers, that meet the highest standards of ethical and professional behavior,” said Patrick E. McFarland, Inspector General of the U.S. Office of Personnel Management. “Today’s settlement reminds the pharmaceutical industry that they must observe those standards and reflects the commitment of federal law enforcement organizations to pursue improper and illegal conduct that places health care consumers at risk.”

The civil settlement resolves one lawsuit filed in federal court in the District of Massachusetts under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private citizens to bring civil actions on behalf of the United States and share in any recovery. As part of today’s resolution, the whistleblower—Cheryl Eckard—will receive approximately $96 million from the federal share of the settlement amount.

The criminal case is being prosecuted by the U.S. Attorney’s Office for the District of Massachusetts and the Department of Justice’s Office of Consumer Litigation. The civil settlement was negotiated by the U.S. Attorney’s Office for the District of Massachusetts and the Civil Division's Commercial Litigation Branch. The HHS Office of Counsel to the Inspector General, the Center for Medicare and Medicaid Services, FDA’s Office of Chief Counsel and the National Association of Medicaid Control Units provided assistance.

The case was investigated by agents from the FBI, the Department of Veterans Affairs, Office of the Inspector General, HHS-OIG, the FDA’s Office of Criminal Investigations, the Defense Criminal Investigative Service, and the Office of the Inspector General for the Office of Personnel Management.

This settlement is part of the government’s emphasis on combating health care fraud. One of the most powerful tools in that effort is the False Claims Act, which the Justice Department has used to recover approximately $4.2 billion since January 2009 in cases involving fraud against federal health care programs. The Justice Department’s total recoveries in False Claims Act cases since January 2009 have topped $5.4 billion.

thus I wouldn't trust GSK further than I can p*ss upwind in a hurricane!
Yeah, there might be profit...they might also be stooges for the government/others they are deeply inbed with.

 

[Cort]

My point was that making any weak statements to the media when you are representing this disease, can at best be interpreted as being clueless about how the media and advocacy works (strong statements do not require overstating what is known) and at worst raises questions about the possibility that the weak statements were included to appease parties other than the patients the CAA is supposed to be representing.

I refuse to to accept the argument that in KM's case $170K doesn't buy you much. I'm just starting to wonder about who's buying it because who ever it is seems perfectly satisfied so far.

I imagine that its people who support the Research Initiative and the Biobank and some of the CAA's successful advocacy efforts...the retention of the CFSAC panel, Dr. Reeves dismissal (which I still think the CAA's critique must have helped with), the new Congressional Fund CFS researchers have to tap into, the webinar program - things like that - there are reasons to support this organization. As I said earlier I would support them for their brain mitochondrial program and the Light studies alone.

Just their support of the Pacific Fatigue Labs repeat exercise work (they were the sole supporters of that)...would keep me going to for a couple of years because I think that work has changed how researchers do their studies. We are much more likely to get positive results now from all sorts of studies by throwing an exercise component in there.

Look at the Light study - at baseline there's no different in receptor levels; without the exercise studies they might not have ever thought to include an exercise component...but doing that changed everything....and exercise was not a prominent feature of your everyday study before the CAA funded the Pacific Fatigue labs work.

While the CAA is underperforming in some very public areas they are performing just fine in others. Two of their researchers have gotten major NIH grants.....that doesn't happen every day....How many new grants on CFS pathophysiology does the NIH fund every hear? 2, 3???? It's a very small number.