CFIDS Association asking expert signatories about their current position on endorsing the CCC

[Nielk]

Where is the money coming from to fund this

 

[justinreilly]

The IOM website states that panelists are not paid.

Thanks for the info.

 

[Ecoclimber]

Is this question for me, Eco? I think our posts crossed, but as I said above, I do not know how much the IOM contract will cost. I've heard that IOM studies usually cost around $1 million, but I'm sure that varies a lot.

Regarding whether the CAA or Dr. Vernon have a conflict of interest re: IOM, I have to point out that no one has offered any documentation showing that they do. When I was on the Board (until the end of 2011) the Association had a very robust conflict of interest policy, and the Board was vigilant for conflicts. I assume that is still the case, particularly in the absence of documentation to the contrary. Also, IOM does not pay its panelists.

Regarding the statement that the Association has a general financial interest in a broader definition because it will allow them to raise more money, that doesn't make much sense. If that were true, then EVERY organization that serves our patient population would have the same conflict of interest. So does PANDORA or WPI or Mass CFIDS or PR have a conflict of interest because a broader definition would help them raise more money? I don't think so.

No Jennie, this was a question for Firestorm. These are not my comments but comments taken from various blogs stating patient concerns.

Although you do have to ask yourself, why at this time is there now any interest to define criteria after 25 years by HSS. Especially while Lipkin and others are still in the process of looking for biomarkers.

The question most important is why did Vernon and Friedberg on the IOM GWS, GWI board reject the scientific data from the Congressional Mandated Research Advisory Committee and instead developed psycho-somatic treatment protocals which outraged the patient community. It seems that if she ignored the bio-medical cause of the neuro-toxins exposure and debilitating condition similar to ME/CFS, then we know which way she will vote on the ME/CFS IOM board, don't we? Past behavior is a predictor of future behavior!

Eco

 

[Firestormm]

Where is the money coming from to fund this

One would obviously say the HHS budget; but whether it is part of that set aside for CFS - or for improving case definitions or suchlike it is hard to know at this juncture. I dare say we will discover the source in due course.

 

[justinreilly]

Regarding the statement that the Association has a general financial interest in a broader definition because it will allow them to raise more money, that doesn't make much sense. If that were true, then EVERY organization that serves our patient population would have the same conflict of interest. So does PANDORA or WPI or Mass CFIDS or PR have a conflict of interest because a broader definition would help them raise more money? I don't think so.

I don't think that the argument that CAA has this conflict of interest should be dismissed as you are doing. I don't know if this potential conflict of interest actually does negatively color decisions made by CAA, BUT SOMETHING DOES. We see that historically, at least, CAA has consistently made decisions and actions inimical to the interests of patients. What EXACT conflicts of interest have made CAA act this way is unknowable for certain for those of us on the outside of CAA, but it is certain that some conflicts of interest have caused CAA to act against the interests of patients. Whether the specific one mentioned here has in fact been significant is uncertain, but should not be dismissed out of hand.

These other organizations you cite have NOT shown the type of anti-patient behavior that CAA has demonstrated, so their example is inapposite.

 

[Firestormm]

Although you do have to ask yourself, why at this time is there now any interest to define criteria after 25 years by HSS. Especially while Lipkin and others are still in the process of looking for biomarkers.

To be blunt: because we asked for it?

I mean the way in which this contract was passed to IOM on the QT, was reprehensible, and communication with interested parties including CFSAC was virtually non-existent; but - and correct me if I am wrong please - HHS can claim that CFSAC and the community at large have been expressing their displeasure for many many many years.

I don't condone the way they have gone about this - but something has been on the cards (and in my view) overdue for years over in the USA. Given all the 'debate' caused by this lack of communication, and the CFIDS letter, expert letter etc. I am left wondering if you'd consider yourselves lucky now to have even the NICE Guideline in place in the USA.

I mean when you consider the possible alternatives it's scary, e.g. the equivalent to the GWI outcome (though I have not read it myself other than all of the concerns expressed about it)*. Then again, if the CCC pass muster (and/or a combination of that and the ICC, with a dose of the methodology from NICE); you could end up with something better than we have - which I really do hope will be achieved, because then NICE might sit up and pay attention: and we could all see an improvement.

Here in a small country far, far, away; NICE are considering placing the CFS/ME Guideline on the 'static' list, pending any significant developments. Well, this could be one event of significance. If, when you have the full facts, you can all come together - not in full agreement - but in presenting a united front in terms of what it is you will accept, and why.

I still do not fully understand if IOM are attempting to write the equivalent to the Full NICE Clinical Guideline, (which tells the NHS how to implement and to diagnose as well as 'treat'), or are more 'simply' trying to arrive at a single definition/criteria and - we hear now - nomen for 'the disease' or diseases.

I must read Jennie's SOW document more carefully. But I don't think it necessary at the moment - until more research is able to point to a testable biomarker - that we need to have separate research and clinical definitions. I just cannot see the point with that - and neither can the 35.

(*Maybe the HHS have a directive to attempt to rationalise/collate/standardise etc. these Medically Unexplained Illnesses and we are next on the list?)

 

[justinreilly]

Firestormm,
I was under the impression that the NICE criteria weren't so nice. Wouldn't it be great, if instead of doing the NICE guidelines, the UK had saved that money and CCC were adopted instead?

It looks inevitable that if this goes through, that mostly non-experts will be employed, plus some BS'ers like Unger, Vernon, Ann Vincent, etc., and perhaps a few actual experts. What is extremely likely to come out of this big waste of money and time? Another fake/flawed CFS definition that will be incredibly hard or impossible to get dislodged! (Plus more official statements that GET is the only effective treatment option) Full-on disaster.

 

[Denise]

Ecoclimber said

“The question most important is why did Vernon and Friedberg on the IOM GWS, GWI board reject the scientific data from the Congressional Mandated Research Advisory Committee and instead developed psycho-somatic treatment protocals which outraged the patient community. It seems that if she ignored the bio-medical cause of the neuro-toxins exposure and debilitating condition similar to ME/CFS, then we know which way she will vote on the ME/CFS IOM board, don't we? Past behavior is a predictor of future behavior!”​

To clarify – Vernon and Freidberg are on the IOM GWI definition committee (currently in process). Neither were on the IOM GWI treatment committee (report published Jan 2013).

 

[Esther12]

Regarding the statement that the Association has a general financial interest in a broader definition because it will allow them to raise more money, that doesn't make much sense. If that were true, then EVERY organization that serves our patient population would have the same conflict of interest. So does PANDORA or WPI or Mass CFIDS or PR have a conflict of interest because a broader definition would help them raise more money? I don't think so.

As a more general point, there is fairly widespread concern that, for a range of medical conditions, these sorts of conflicts of interests via patient groups, clinicians and researchers, all lead to ever expanding diagnoses. (Not that I'm saying I know this is a problem with the CFIDS - to be honest I still don't really know who this, or organisations like the CAA, are. Are the CFIDS and CAA the same? Or linked?).

________________________________________________________________________________________

Personally, I'm not convinced that any of the criteria for CFS or ME are really that great, but also think that it really depends on how these diagnoses are used. If a diagnosis of CFS or ME is being used to routinely promote a particular intervention or treatment, then the criteria should be able to reflect this. ie: If it being used to suggest some anti-viral treatment, the diagnosis should require some positive evidence of viral involvement. If the diagnosis is being used to suggest a cognitive-behavioural intervention, then it should require some positive evidence of cognitive distortions, or behavioural problems.

I don't think that it is safe to offer any treatments for CFS or ME unless they are being clearly sold as being experimental, and ideally, are part of a controlled trial. If the IOM is going to make any suggestions about treatment, they will need to completely re-configure all of the available criteria, and then conduct their own trials on possible treatments. This will cost a lot more than a million dollars.

If it is for the purpose of research, then really, trying to come up with a new criteria, at this point in time, seems foolish. All research should be done with an eye to identifying meaningful sub-groups, and I don't really see how, without a breakthrough of some sort, the IOM could possibly come up with a wonderful new criteria which is much better than any of the others. When CFS research is such a quackfest, just having a load of outsiders casually review the evidence is not likely to do anyone any good. What I read of the gulf-war report seemed deeply worrying, and representative of a lot of what is worst about the morally lazy pragmatism that has done so much to harm how CFS patients are viewed and treated. Maybe I just read particularly bad bits, but it did not inspire any confidence that their work with CFS would be anything but harmful.

(I was tempted to write much more on this complicated topic... but managed to stop myself).

 

[Valentijn]

I still do not fully understand if IOM are attempting to write the equivalent to the Full NICE Clinical Guideline, (which tells the NHS how to implement and to diagnose as well as 'treat'), or are more 'simply' trying to arrive at a single definition/criteria and - we hear now - nomen for 'the disease' or diseases.

If they're doing the same things they did to Gulf War Illness, it'll be more like NICE guidelines. I think the GWI document was 118 pages long, and had a lot of stuff about treating comorbid problems. I didn't read the rest, but presumably it also talks about treating the primary GWI (and every other conceivable related topic).

 

[Nielk]

To be blunt: because we asked for it?

I mean the way in which this contract was passed to IOM on the QT, was reprehensible, and communication with interested parties including CFSAC was virtually non-existent; but - and correct me if I am wrong please - HHS can claim that CFSAC and the community at large have been expressing their displeasure for many many many years.

I don't condone the way they have gone about this - but something has been on the cards (and in my view) overdue for years over in the USA. Given all the 'debate' caused by this lack of communication, and the CFIDS letter, expert letter etc. I am left wondering if you'd consider yourselves lucky now to have even the NICE Guideline in place in the USA.

I mean when you consider the possible alternatives it's scary, e.g. the equivalent to the GWI outcome (though I have not read it myself other than all of the concerns expressed about it)*. Then again, if the CCC pass muster (and/or a combination of that and the ICC, with a dose of the methodology from NICE); you could end up with something better than we have - which I really do hope will be achieved, because then NICE might sit up and pay attention: and we could all see an improvement.

Here in a small country far, far, away; NICE are considering placing the CFS/ME Guideline on the 'static' list, pending any significant developments. Well, this could be one event of significance. If, when you have the full facts, you can all come together - not in full agreement - but in presenting a united front in terms of what it is you will accept, and why.

I still do not fully understand if IOM are attempting to write the equivalent to the Full NICE Clinical Guideline, (which tells the NHS how to implement and to diagnose as well as 'treat'), or are more 'simply' trying to arrive at a single definition/criteria and - we hear now - nomen for 'the disease' or diseases.

I must read Jennie's SOW document more carefully. But I don't think it necessary at the moment - until more research is able to point to a testable biomarker - that we need to have separate research and clinical definitions. I just cannot see the point with that - and neither can the 35.

(*Maybe the HHS have a directive to attempt to rationalise/collate/standardise etc. these Medically Unexplained Illnesses and we are next on the list?)

CFSAC's recommendation was not to reinvent the wheel and start to redefine the illness from scratch. What they asked and have been asking for years is for HHS to adopt the CCC which is in current use by clinicians and researchers. It is much improved over the CDC Fuduka which HHS has been glued to for 20 years. CFSAC then asked to have only ME/CFS experts work on improving on the CCC.

This is totally different and opposite of what they are actually doing now.

The biggest slap in the face is the fact that they claim that this work with the IOM is in support of CFSAC!!
Do they really think that we are brain dead? We might be fogged but not dead.

I have to state here that my blood is boiling over this. The underhandedness of all of HHS actions here are really outrageous.

Why is it that they kept all this silent until the last minute when it was too late for patients or stakeholders to protest this?

How can we now trust ANYTHING that the HHS does?

From the description in the state of work that Jennie's blog refers to here, it is conceivable and within the framework of the HHS request that only one ME/CFS expert serve on the panel. How comfortable is anyone here with that fact?
the IOM prides itself on it's diverse panel of experts. We have seen their selection with the GWI panel. How blind do they think we are?

In addition, only one meeting needs to be open to the public as per HHS statement of work. Patients will only have one day when they can voice their opinion and testify. How much input do you really think we are going to have in this process.

As far as the selection of the panel members, we can nominate some up it's up to the institute to actually decide who will serve and they will not be swayed by any group since they are an independent entity.

 

[Liz Willow]

Where is the money coming from to fund this

Good question. It's coming from HHS. Yet HHS has told advocates it had no money to create an inter-agency strategic plan. HHS has created such plans (HHS refers to them as "Health Plans") for other health issues. It has the authority to do this on its own, without Congressional authorization. If HHS has a million or so for this disaster, why couldn't it use it instead to create something similar to the strategic plans for Autism or Alzheimer's?

 

[Denise]

The question about funding sources for this is interesting in light of what the announcement said about there being co-sponsors.

"The Office on Women’s Health/HHS is co-sponsoring the IOM study with several agencies that participate in CFSAC. "​

and the fact that the Statement of Work says:

“IOM shall furnish the complete list of project sponsors and their funding amounts.”

(emphasis added)

And when will we see the complete list and their funding amounts.....?

 

[Nielk]

PANDORA's letter to the experts:
https://www.facebook.com/note.php?note_id=684973141522553


As most of you know, our organization supports what the majority of ME/CFS experts recommend in matters of scientific process, including developing a good definition for the disease. Starting with the 2003 CCC, we believe it’s time for ME/CFS clinical and research definitions that change the name, include subgroups, include biomarkers and a way to designate with severe functional limitations.

Developing a consensus or this to happen, more action is needed than just publishing proposals in the medical literature. Starting on September 30, we have been sending emails to the 35 signatories asking what next step they have planned and to offer our assistance to them.

This is the wording of this email we are sending to them:

Dear Dr. _______,

As the president of PANDORA Org, we are very concerned with all that has transpired in recent weeks concerning the ME/CFS definition. A quick summary:

• An announcement was made of an intended contract between Dept. of Health and Human Services Office of Women’s Health and the Institutes of Health to conduct a workshop that will lead to a consensus among the medical professional community at large on an ME/CFS definition.
• Many patient advocates started a campaigned to stop that contract fearing the intent was to develop a new definition without the input of ME/CFS experts.
• You and 34 other ME/CFS experts signed a letter urging the IOM contract be canceled and all HHS departments endorse and use the 2003 Canadian Consensus Criteria.
• Hours after that letter was put out to the public, the Chronic Fatigue Syndrome Advisory Committee gave more details on the IOM contract that they said was in response to the patients. (see this:http://www.occupycfs.com/2013/09/23/contract-signed/)
• Based on the letter you signed, many patients continue to campaign to the HHS to cancel the IOM contract.

We are pleased to see you and others assert your position as an ME/CFS expert. Although we know not all ME/CFS experts signed this letter, we want to support the scientific and medical judgment of the majority of our experts.

As all these matters transpired, we were talking to many involved parties to gain insight. We then published our position statement: http://bit.ly/1barAPX In that position statement, we mention that some leadership or other action is required to form a consensus on a disease definition beyond just our ME/CFS experts. We also point out that scientific process has revealed more about ME/CFS so that a definition with biomarkers and subgroups is possible and needed and a new name for the disease is needed.

We have spoken to two IACFS/ME board members who tell us they do not have the funds, manpower or time to put together a workshop or other mechanism to create the updated definition and get it widely accepted among medical professionals and do away with the “CFS” moniker.

Because you and the 34 others have spoken as scientific leaders on ME/CFS, we offer our support to what you as a group plan as a next step to create the needed progress. What next step do you have planned? Are you considering a workshop?


Most Kindly,

Lori Chapo-Kroger, RN
President & CEO
PANDORA Org
http://pandoraorg.net

 

[Sasha]

Great - I think those 35 experts should do a workshop, along with any who want to join them (I think a lot of potential signatories may not have had a chance to sign).

 

[Ember]

CFSAC's recommendation was not to reinvent the wheel and start to redefine the illness from scratch. What they asked and have been asking for years is for HHS to adopt the CCC which is in current use by clinicians and researchers. It is much improved over the CDC Fuduka which HHS has been glued to for 20 years. CFSAC then asked to have only ME/CFS experts work on improving on the CCC.

To be fair, this is the most recent (October 2012) CFSAC recommendation:

CFSAC recommends that you will promptly convene (by 12/31/12 or as soon as possible thereafter) at least one stakeholders’ (Myalgic Encephalomyelitis (ME)/Chronic Fatigue Syndrome (CFS)experts, patients, advocates) workshop in consultation with CFSAC members to reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS beginning with the 2003 Canadian Consensus Definition for discussion purposes.

 

[Nielk]

To be fair, this is the most recent (October 2012) CFSAC recommendation:

How does my post differ from CFSAC 10/12 recommendation?

 

[readyforlife]

I really appreciate that Pandoraorg.net has posted a position statement on ME/CFS criteria. Why can't the (CAA) Cfids.org do the same. I've emailed them asking where they stand and why. But of course they haven't responded or even posted anything on their website on why they don't oppose the IOP contract.

 

[Ember]

How does my post differ from CFSAC 10/12 recommendation?

Your post reads, “adopt the CCC” and then “work on improving on the CCC.” The CFSAC recommendation reads, “reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS beginning with the 2003 Canadian Consensus Definition for discussion purposes.”

The Statement of Work similarly begins with the CCC for discussion purposes, but adds to its list other sources for review:

The Committee should review the efforts that have already been done, including the 2003 ME/CFS Canadian Consensus Definition, the 2007 NICE Clinical Guidelines for CFS/ME, the 2010 Revised Canadian ME/CFS Definition, the 2011 ME International Consensus Criteria, and data from the ongoing CDC Multi-site Clinical Study of CFS.

 

[asleep]

I don't think that the argument that CAA has this conflict of interest should be dismissed as you are doing. I don't know if this potential conflict of interest actually does negatively color decisions made by CAA, BUT SOMETHING DOES. We see that historically, at least, CAA has consistently made decisions and actions inimical to the interests of patients. What EXACT conflicts of interest have made CAA act this way is unknowable for certain for those of us on the outside of CAA, but it is certain that some conflicts of interest have caused CAA to act against the interests of patients. Whether the specific one mentioned here has in fact been significant is uncertain, but should not be dismissed out of hand.

These other organizations you cite have NOT shown the type of anti-patient behavior that CAA has demonstrated, so their example is inapposite.

I completely agree, but I would put it slightly differently:

All disease advocacy/research organizations are born into and exist within an inherent state of conflicted interest. Any positive strides made in understanding/treating/curing the disease in question will necessarily have a corresponding, negative impact on the longevity and usefulness of these organizations. In other words, the success of their mission destroys their purpose.

Therefore, there is no need to pinpoint exact conflicts of interest within these organizations. Their mere existence is enough to presume they are conflicted unless they demonstrate persistently, aggressively, and concretely that they are actually committed to their own obsolescence.

In the specific case of the CAA, I don't think they've done anything (since their very early days) that could reasonably be construed as indicative of a genuine alignment with the patient community. They are fully in the business of self-preservation at our direct expense. Where they've managed to not be outright hostile to efforts at advancing an understanding of the disease, they've done little more than vacuous busywork and insidious undermining by "strengthening alliances" with government agencies that are themselves historically and actively hostile toward this disease.

Undoubtedly, this post will be criticized as "mean" or "unfair," but it is precisely the attitude and outlook motivating such criticisms which ensures that this community will continually subvert itself by unreservedly granting allegiance to false and unworthy saviors.