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

[Esther12]

$1 Million seems very excessive

Wasn't the $1 million just speculative anyway? Details on cost still have not been released.

 

[justinreilly]

Wasn't the $1 million just speculative anyway? Details on cost still have not been released.

Yes, you're right. I tried to find out what the budget and breakdown of it was for the last GWI report from IOM, but couldn't find anything. All I could find was a third-party's listing of the costs of the nine IOM GWI reports through August 1, 2002. According to this site, at least, there were nine reports costing an average of $1,826,000 each.
http://www.gulflink.org/iom/iom.html

The only other info I found was a cost of $8.5M for a report on geographical differences in health care.

 

[justinreilly]

I wrote to CAA's board:

Please forward to CAA Board of Directors
Please cc to CAA Officers and Public Relations/Outreach Director

Members of the Board:

Let me first express my appreciation for the apparent strides CAA has made in the last year or so. In my eyes, these include steps like removing the CDC toolkit and other misinformation from your website, your increased focus on an apparently (to my mind, which has quite limited scientific literacy) well-thought out research plan, the use of "ME" in ME/CFS, increased communication with patients, the inclusion of PEM/PER/PENE as a requirement for contributions to your biological sample bank, the installation of a new CEO, and perhaps other initiatives of which I am unaware.

In my strong and well-considered view, there is still great improvement to be made. I am writing you now because of your expressed support of the contract between HHS and IOM for a new clinical case definition for ME. A few months ago, many organizations and patients signed a petition to HHS to change the name of the disease back to ME and to immediately adopt the CCC. More recently, a great number of patients have contacted HHS and Congress to demand that the CCC be immediately adopted and that the IOM contract not be signed (and now cancelled). As you know 35 (now 34) of the very top ME researchers and clinicians in the world wrote to HHS demanding the same thing- no IOM contract and immediate adoption of CCC.

You are well familiar with the reasons for these demands (If you wish to be reminded, I simply refer you to the letter by the 35, now 34 experts). You stand virtually alone among stakeholders in your approval of the IOM contract. I now strongly request that you change your stance for the good of the whole community.

A year or two ago, in response to a deluge of criticism by patient activists/experts, CAA announces that it was now focused as a "laser" on research and was no longer a patient advocacy organization. I strongly object to your coming out now into the public arena as a supposed patient advocate, by doing such things as stating your support for the IOM contract, contacting the 35 signatories to subtly influence them to change their views, and it seems, responding to members of congress and the press as a patient organization.

The announcement by HHS of the IOM contract did very little to address the concerns of patients, clinicians and researchers, despite your claims and those of HHS to the contrary. The contract is at fundamental odds with the request for a stakeholder definition meeting by CFSAC and will be loaded with non-experts who will almost certainly screw things up royally (especially apparent in light of IOM's recent Gulf War Illness report). Please reconsider your position, I beg you, for the good of everyone.

I very much welcome contact from any or all of the board for friendly discussion. In any event, I look forward to a timely response. Thank you for your consideration.

Sincerely,
/s/
Justin Reilly, esq.

 

[Marty]

Excellent letter to CAA, Justin. People seem to think the doctors' letter was about the name or the definition, but it wasn't. It was about asserting the doctors' authority to name and define the disease as they wish and as they have been doing for 10 years, and for the government to accept (and fund) that. And now for the CAA to accept the doctors' expertise and to help assure that the IOM gets cancelled. (For evidence, just look at what IOM did to Gulf War Illness.) I hope that those who still support the CAA will encourage CAA to change their position and to refuse all requests from the media who still assumes they are an advocacy organization. Support for our doctors is critical right now. It is not saying you agree with any definition or name. It's just saying that our doctors have the experience with the patients, which the CDC doesn't, and our doctors have a history of listening, which the CDC certainly does not.

 

[Ecoclimber]

I wrote to CAA's board:

Excellent. The pressure must be continuous until they relent. Add the board of directors of Pandora and Offer (Bateman) in Utah as well. Critical Mass is needed from everyone to get their attention!

Eco

 

[leela]

Ecoclimber - And I remember something like 6-8 months ago a new NIH grant of $500-800,000 was given to Friedberg to study coping with fatigue.

Okay I know this is sort of OT but for cryin' out loud we are *all* fricking experts on coping, and with a lot more than fatigue!! I am so over this crap!! Someone should give *us* all that money for having already coped for decades now!

 

[Ember]

Ecoclimber - And I remember something like 6-8 months ago a new NIH grant of $500-800,000 was given to Friedberg to study coping with fatigue.

Time flies. We discussed that $600,000 NIH grant here two years ago. Dr. Friedberg's study reports huge dropout rates, by the way: “Dropout rates at the 12-month follow-up were high (42%-53%), perhaps attributable to the burden of monthly telephone calls to assess health care use.”

:thumbdown:

 

[alex3619]

Okay I know this is sort of OT but for cryin' out loud we are *all* fricking experts on coping, and with a lot more than fatigue!! I am so over this crap!! Someone should give *us* all that money for having already coped for decades now!

They could get coping programs out there at minimal cost just by hiring a bunch of long term patients. We live with it, most psychs only read papers about it or use outlandish theories.

 

[Nielk]

This was posted by Wildaisy on mecfsforum:

This is Dr. Mikovtz' response to CAA's letter to the 35.

Yes they did and below is the response I sent:​

​

To whom it may concern:​

I absolutely stand by my work of the last 7 years including my signature on the letter to secretary Sebelius of 9/23 regarding the case definition of ME/CFS.​

​

I know that the CAA is not and has never in my experience responded to concerns expressed by the patients nor do they now or have they ever served in the best interests of the patients as is the only duty of an advocacy organization. This IOM contract is simply a waste of precious resources.

I stand by my signature on the letter and my work which is now always has been and will always be in the best interests of the patients.​

​

Sincerely,​

​

Judy A Mikovits, PhD​

 

[justinreilly]

Time flies. We discussed that $600,000 NIH grant here two years ago. Dr. Friedberg's study reports huge dropout rates, by the way: “Dropout rates at the 12-month follow-up were high (42%-53%), perhaps attributable to the burden of monthly telephone calls to assess health care use.”

:thumbdown:

Oops, wow, time does fly!

 

[beaker]

This was posted by Wildaisy on mecfsforum:

This is Dr. Mikovtz' response to CAA's letter to the 35.

Yes they did and below is the response I sent:​

​

To whom it may concern:​

I absolutely stand by my work of the last 7 years including my signature on the letter to secretary Sebelius of 9/23 regarding the case definition of ME/CFS.​

​

I know that the CAA is not and has never in my experience responded to concerns expressed by the patients nor do they now or have they ever served in the best interests of the patients as is the only duty of an advocacy organization. This IOM contract is simply a waste of precious resources.

I stand by my signature on the letter and my work which is now always has been and will always be in the best interests of the patients.​

​

Sincerely,​

​

Judy A Mikovits, PhD​

Go Judy !

 

[justinreilly]

More from Wildaisy:

http://www.mecfsforums.com/index.php/topic,17834.15.html

Reply #16
I have contacted as many of the people who signed the Open Letter to Dr. Sebelius as I was able to, and I have gotten some answers. Some people were not contacted by the CAA. Some were contacted and refused to withdraw their support from the CCC. If I receive permission, I'll post their responses.

It is absolutely clear to me from what they have told me that the CAA was, indeed, attempting to get these signers to withdraw their support from the CCC and to support the CAA in its support for the IOM contract.

 

[Andrew]

I have to say this whole thing has hit me like a kick to the belly. I have not come to realize that it's not simply a matter of activism by energizing the CFSAC, because even that has been undermined.

As I see it, urging from a couple of CFSAC members got a majority to take a stand on the definition. They decided to vote in the CCC to be (at the very least) the de facto interim definition. And it looked like they were not going to give up on this. As soon as this started to gain force behind it, the HHS stepped in and yanked it out of the hands of the CFSAC put advertised a contract for someone to do it. This ad was put up without notice to the ME/CFSAC experts of the patient advocates. As soon as the interested parties found out about this and started to oppose it,, the HHS made a choice to become even more underhanded. Instead of simply working under the radar, they announced that because of the public objection, they had canceled the process to of awarding the contract. And a few days later, we found out that the contract was awarded and the project underway. And all of this despite them saying repeatedly there was no money for research.

I think this clearly shows how far they will go. And they have made it crystal clear that they will do whatever is necessary to shut down a process that the recognized experts support. They don't even care that it is obvious that they lied to the public.

 

[Nielk]

CAA posted "Clearing the Air".

As the conversation concerning the HHS/IOM contract continues, many advocates are weighing in. Over the past several days we’ve received several questions about various points in the discussion so we wanted to address them.
First, I sent an email to my colleagues who signed the letter to Secretary Sebelius asking to adopt the Canadian Consensus Criteria and cancel the IOM contract. There is speculation that I asked them to rescind their signature. I did not ask anyone to rescind their signature or change their mind. I reached out to those I had email addresses for (29 signatories), asking if they still agreed with the letter given the IOM contract was awarded and more information on the scope of work had been provided. I heard from about half of the signatories. Several stood by their signature indicating the money for the contract should go to research. Others didn’t feel an IOM committee would do a good job. And yet others were hopeful that the IOM contract would be productive and effective. It was important to hear this because we value their expertise and opinions. Many look to us for insight, opinion and information. We try to understand all sides of an issue so we can provide the most balanced information and make the most informed decisions.

Many of my fellow advocates have asked if I am benefiting financially from my participation on the IOM committee for development of a case definition for chronic multisymptom illness. I am not. Committee member air travel and lodging are paid for with the IOM contract – which was awarded to the IOM by the Veterans Administration. Committee members receive a per diem to cover costs incurred during travel, but all work is voluntary. Outside of the meetings we have a lot of reading and research to do to accomplish our charge. Like in ME/CFS, there has been outstanding work and research on Gulf War Illness and there are significant gaps in knowledge. No one on the committee takes this responsibility lightly. We have 3 more months and two more committee meetings to complete our tasks.
Several individuals have speculated that I am on this committee purely because my brother has Gulf War Illness (my brother is happy that I was nominated and he is hopeful for our outcome), but that is not why. I was nominated for the committee because of my work and research on ME/CFS. My brother relates to ME/CFS patients because as he and many of you know, Gulf War Illness and ME/CFS have many clinical similarities. For those of you that haven’t yet, please read his personal story: http://www.cfids.org/cfidslink/2010/020304.asp [1]

Some that are deeply opposed to the IOM contract to develop a clinical case definition for ME/CFS do not understand why we are in the discussion if we are an organization focused on research. It is precisely because we are focused on research that case definition is important to us. A physician or healthcare provider can only diagnose ME/CFS after thorough clinical evaluation. It is critically important that this clinical approach to diagnosing ME/CFS be defined and standardized for use by all physicians and providers. The diagnostic criteria is essential to advance research because it provides us with the disease-defining concepts – the core signs and symptoms – needed to identify and validate biomarkers and to provide evidence of treatment benefit.
While we understand the concerns over the contract with the IOM: fears that the right people will not be on the committee, leading to a lack of commitment and faulty results, we believe it is in the patients best interest to continue to foster a positive working relationship with HHS and IOM. No single organization can solve ME/CFS on its own. We must have the cooperation and involvement of the various federal agencies to increase research funding and achieve real progress. We can only do that if we are at the table.

We all have a lot of urgent work to do and we all can continue to contribute and help our community. There is plenty of work that needs to be done – more than enough to go around. We must galvanize around ME/CFS in order to conquer it.

 

[Ember]

The Clearing the Air argument is made in support of the IOM contract, designed to develop a “clinical case definition and a clear distinction from case definitions for clinical trials and research.” Yet the argument slips from discussing a “clinical case definition” to a "case definition” to advancing research "needed to identify and validate biomarkers and to provide evidence of treatment benefit:”

Some that are deeply opposed to the IOM contract to develop a clinical case definition for ME/CFS do not understand why we are in the discussion if we are an organization focused on research. It is precisely because we are focused on research that case definition is important to us....The diagnostic criteria is essential to advance research because it provides us with the disease-defining concepts – the core signs and symptoms – needed to identify and validate biomarkers and to provide evidence of treatment benefit (emphasis added).”

Framing that argument are these statements that may be difficult to reconcile:

“I heard from about half of the signatories.... We try to understand all sides of an issue so we can provide the most balanced information and make the most informed decisions;”

“We must have the cooperation and involvement of the various federal agencies to increase research funding and achieve real progress. We can only do that if we are at the table (emphasis added).”

Who is this "we?" Cynically, their statement would have made more sense to me had it read, “[CFIDS Association of America] must have the cooperation and involvement of the various federal agencies to increase [its] research funding.... We can only do that if we are at the table.”

 

[Ecoclimber]

"we believe it is in the patients best interest to continue to foster a positive working relationship with HHS and IOM. No single organization can solve ME/CFS on its own. We must have the cooperation and involvement of the various federal agencies to increase research funding and achieve real progress. We can only do that if we are at the table."

The Real Truth:
We have observed over the last 35 years the results of the historical track record of both the CAA and the Feds through this message of detente.

Facts: Funding was slashed; Grants were awarded for psycho-somatic disorder research while funding for medical research were refused; The CDC, NIH, HHS refused to recognized the CCC or the ICC-ME case definition; the CDC refused to rename the illness, remove their toolkit and foster among medical clinicians CBT/GET as theraputic modalitis for our condition; this illness was placed in the Office of Research on Women's Health; held CFSAC committee meetings over the last decade with zip to show for it; huge salaries to the leadership, very little funding for research; most breakthroughs came through private donations from foundations and small NIH grants; we have seen the lack of results from the CAA unsuccessful advocacy campaign; the neutral stance for the benefit of the CAA leadership over their patients.....

Result: Patients are treated with disdain and marginalize among the medical establishment throughout this country since the label CFS was attached to this illness. No viable medical treatment options are available other than SSRI. Not only do patients have to suffer from this illness, but also have to suffer from the arrogance and lack of empathy and compassion among those doctors who are relunctant to treat them. Patients have only a handful of medical clinicians willing to treat this illness.

VA IOM Gulf War Contract:
Fact: We have seen the real purpose behind the IOM contract with the Gulf War Veterans. We have witnessed the catastrophic devastation among Gulf War Veterans by eliminating their medical and disability benefits through the reclassification of their illness from GWS to CMI (Psycho-somatic disorder).18-22 suicides per day. We have seen how the panel consisted of those who were predispose to a psycho-somatic resolution. We have seen how this committe ignored the scientifc data from the Congressionally mandated Reseach Advisory Committee. We have seen how the committee votes on an impossible exclusionary statement that required a definitive causation factor to the exposure of neuro-toxins and their illness.
http://tinyurl.com/m5rc2kx

Vernon is proud of these facts? The CAA must be worried to come out like this! It means we are making headway toward Critical Mass!

Eco
Inaptitude should never be rewarded!

 

[Esther12]

This is a genuine query, because I realise that I may just be ignorant of something here, but why is it vital to now devise a standardized criteria to be used by all physicians and providers?

It is critically important that this clinical approach to diagnosing ME/CFS be defined and standardized for use by all physicians and providers. The diagnostic criteria is essential to advance research because it provides us with the disease-defining concepts – the core signs and symptoms – needed to identify and validate biomarkers and to provide evidence of treatment benefit.

What makes them think that they will be able to do this in a way which will not harm patients?

Without valid biomarkers, how can they have any confidence that they're creating a criteria which will aid their identification?

CFS is a mess, and the current confusion around criteria is a good representation of this. Some 'expert group' constructing a new criteria for use by all physicians seems really unlikely to be helpful. Research all needs to be done with an intense awareness of the limitation of the value of any of the CFS criteria floating around, and physicians should be aware of this too.

There is speculation that I asked them to rescind their signature. I did not ask anyone to rescind their signature or change their mind. I reached out to those I had email addresses for (29 signatories), asking if they still agreed with the letter given the IOM contract was awarded and more information on the scope of work had been provided. I heard from about half of the signatories.

Have they still not released this letter? It must be really embarrassing then!

I don't really know enough about the IOM Gulf-war report. It looked bad to me (and I read a fair amount of it) and I'm not willing to give them the benefit of the doubt on this (or anything else), but I also can't be certain about my criticism of it at this point. It would be interesting to know how the CAA think it is going. Do they see the gulf-war process as a promising sign for the IOM's CFS work? Or a worrying one?

 

[Nielk]

Vernon said:

I reached out to those I had email addresses for (29 signatories), asking if they still agreed with the letter given the IOM contract was awarded and more information on the scope of work had been provided.

Why did she feel a need to ask them that? CAA came out with their thought out and full statement of support for the IOM contract so why did they have the need to know what the clinicians were doing? Would their response affect CAA's position in any way? If not than why ask?

There is speculation that I asked them to rescind their signature. I did not ask anyone to rescind their signature or change their mind. I reached out to those I had email addresses for (29 signatories), asking if they still agreed with the letter given the IOM contract was awarded and more information on the scope of work had been provided. I heard from about half of the signatories. Several stood by their signature indicating the money for the contract should go to research. Others didn’t feel an IOM committee would do a good job. And yet others were hopeful that the IOM contract would be productive and effective. It was important to hear this because we value their expertise and opinions. Many look to us for insight, opinion and information. We try to understand all sides of an issue so we can provide the most balanced information and make the most informed decisions.

She does not state anywhere that any of the clinicians asked to rescind their positions.

Some that are deeply opposed to the IOM contract to develop a clinical case definition for ME/CFS do not understand why we are in the discussion if we are an organization focused on research. It is preciselybecause we are focused on research that case definition is important to us.

This case definition is not for research purposes. The work on case definition for research is being done at CFSAC with a workshop. Nothing to do with this IOM contract.

A physician or healthcare provider can only diagnose ME/CFS after thorough clinical evaluation. It is critically important that this clinical approach to diagnosing ME/CFS be defined and standardized for use by all physicians and providers.

That's exactly why CFSAC asked them to adopt the CCC to be used immediately by all clinicians. We have it - why re-invent?

While we understand the concerns over the contract with the IOM: fears that the right people will not be on the committee, leading to a lack of commitment and faulty results, we believe it is in the patients best interest to continue to foster a positive working relationship with HHS and IOM.

That has really worked out well for CMI, hasn't it?

I have to add here that I think (my personal opinion) that the CAA is really overstating their possible influence with this IOM contract. IOM was supposedly picked because they are an independent, non-government, non-profit organization. They pride themselves on their independent actions. If they do accept any influence by any patient group, government branch or any political or social organization, their independent statures will come in to question and they can't afford that.

From the moment that this contract was signed, it is on track to be dealt with the exact same way as the GWI contract. This is the way of IOM studies. We are not going to change that. It's like a train, once it's on a track, it will follow that track. If it sways, it will derail.

 

[alex3619]

The Clearing the Air argument is made in support of the IOM contract, designed to develop a “clinical case definition and a clear distinction from case definitions for clinical trials and research.” Yet the argument slips from discussing a “clinical case definition” to a "case definition” to advancing research "needed to identify and validate biomarkers and to provide evidence of treatment benefit:”

Framing that argument are these statements that may be difficult to reconcile:

“I heard from about half of the signatories.... We try to understand all sides of an issue so we can provide the most balanced information and make the most informed decisions;”

“We must have the cooperation and involvement of the various federal agencies to increase research funding and achieve real progress. We can only do that if we are at the table (emphasis added).”

Who is this "we?" Cynically, their statement would have made more sense to me had it read, “[CFIDS Association of America] must have the cooperation and involvement of the various federal agencies to increase [its] research funding.... We can only do that if we are at the table.”

Two clear points:

1. We need to galvanize research so,
2. We need to support an unnecessary clinical definition.

The logic is clear. There isn't any.

 

[alex3619]

I have to add here that I think (my personal opinion) that the CAA is really overstating their possible influence with this IOM contract. IOM was supposedly picked because they are an independent, non-government, non-profit organization. They pride themselves on their independent actions. If they do accept any influence by any patient group, government branch or any political or social organization, their independent statures will come in to question and they can't afford that.

From the moment that this contract was signed, it is on track to be dealt with the exact same way as the GWI contract. This is the way of IOM studies. We are not going to change that. It's like a train, once it's on a track, it will follow that track. If it sways, it will derail.

The terms of the contract define what the IOM can do, limit the methods, and immunize the IOM against outside influence aside from specific stakeholder involvement that they permit. Poor terms in this contract will derail it, period. That starts with the initial one we know about. They are to define a single case definition for ME/CFS. Sure they are to allow subgroups .. but defined how, on what evidence?

Of course similar criticisms can be directed at the CCC, which is a single case definition. The difference is that the researchers using the CCC are well aware of subgroups and their importance, and the science behind it. It is not clear this will be the case with the IOM.

Their directive/goal, the experts chosen, and how evidence is permitted or weighted may predefine the outcome regardless of the integrity of those doing the study. This is not a question of IOM integrity, its a question of whether or not the approach is valid for this situation. I don't think it is.