Poll: IOM Contract

[justinreilly]

Delia
Four great people for your friend to talk to would be patient Bob Miller, his wife Courtney Miller (both of whom are on PR I believe) and Llewellyn King of White House Chronicles, who is a longtime journalist who is a friend of a patient and has written and videod a lot in the past couple of years on ME. And Hillary Johnson.

 

[Delia]

Great! I will let her know!

Delia
Four great people for your friend to talk to would be patient Bob Miller, his wife Courtney Miller (both of whom are on PR I believe) and Llewellyn King of White House Chronicles, who is a longtime journalist who is a friend of a patient and has written and videod a lot in the past couple of years on ME. And Hillary Johnson.

 

[justinreilly]

Chronology of IoM Contract Events by Gabby Klein:
http://forums.phoenixrising.me/inde...vents-of-the-hhs-contract-with-the-iom.25933/

 

[Ember]

3) it's not unusual for the government to be involved in disease definitions in other diseases--though it isn't required. It probably sounds extreme to the government, for us to ask them to step out since it is customary for the government to be involved from time to time, in even mainstream diseases. However they would normally follow rules like 1 and 2. It's highly suspicious that they did not in this case start with 1. So I think it's clear and a fair point that they are doing it wrong.

In the development of the CCC, Health Canada established the "Terms of Reference" and selected the Expert Consensus Panel. The initiative for and development of the ICC, on the other hand, was done outside any organization without any financial or other assistance or sponsorship.

 

[alex3619]

Ember, I am unaware of the details of how Health Canada was involved in setting terms of reference for the CCC. Is it possible this could be used as an example of a good model to follow, to compare it to what the IOM does?

 

[Ember]

Ember, I am unaware of the details of how Health Canada was involved in setting terms of reference for the CCC. Is it possible this could be used as an example of a good model to follow, to compare it to what the IOM does?

According to Marj van de Sande, the Terms of Reference for the Canadian Consensus Panel established by Health Canada required that it consist of at least 10 members, 4 of whom could come from outside Canada. I'm not aware that the document itself was ever published, and given that work on the CCC began in 1999, it must be well over a decade old now. Do you think that it would be worthwhile to find out more?

 

[alex3619]

Ember, if this is the only example of terms of reference for a panel that achieved a good result, then we probably need to look at it. Most government documents get archived, usually with backups. This could be a valuable resource. For one thing it will provide a benchmark to compare the IOM against. For another it can assist us with understanding how these outcomes are achieved. Its not all about the experts, its also about the rules they have to follow. That has been long known by those creating committees and panels, and is a good and less visible way to sway the outcome. We just do not know the rules for the IOM, but we can infer them from the Gulf War report and other documents.

Too often when out of scrutiny "evidence-based' processes get turned into a play by the numbers formula. Real thought and complex analysis are excluded by the huge volumes of material. They simply do not have the time, and they are not researchers - they have to accept what studies say. As such the outcomes are railroaded down a specific track by the constraints they have to follow. We also have a good idea where that track leads.

 

[Ember]

Ember, if this is the only example of terms of reference for a panel that achieved a good result, then we probably need to look at it.

The “Terms of Reference” were established by Health Canada after the draft clinical definition had been written. Health Canada selected the Expert Consensus Panel for ME/CFS with at least one member having been nominated by each of five stakeholder groups: government, universities, clinicians, industry, and advocacy. Panel members had to be practicing MDs actively treating and/or diagnosing ME/CFS, or MDs or Ph Ds involved in clinical research of the illness. The members of the panel had autonomy over their consensus document.

A description of Health Canada's “Terms of Reference” is included in the ME/CFS Guidelines under the heading, Development of the Canadian Consensus Document:

The National ME/FM Action Network of Canada spearheaded the drive for the development of an expert consensus document for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). In response to increasing numbers of patients inquiring about doctors knowledgeable about ME/CFS, the Network sent a questionnaire to doctors across Canada asking what items would be most helpful in assisting them with their ME/CFS patients. The physicians concurred that a clinical definition, as well as diagnostic and treatment protocols were of prime importance.

The National ME/FM Action Network then approached two clinicians knowledgeable about ME/CFS and experienced in its diagnosis and treatment. Dr. Bruce Carruthers of British Columbia and Dr. Anil Jain of Ontario kindly agreed to co- author a draft document. Lydia Neilson, President of the National ME/FM Action Network, met with the Honourable Alan Rock, then Minister of Health, to discuss the results of the doctors’ survey and the draft document. The Honourable Alan Rock responded by stating the draft clinical definition was “a milestone in the fight against this complex and tragic condition”.

Health Canada established the “Terms of Reference”. One stipulation was that at least one member of the panel must be nominated by each of the five stakeholder groups of government, universities, clinicians, industry, and advocacy. There had to be at least ten members on the panel, four of whom could come from outside of Canada. Panel members had to be practicing MDs actively treating and/or diagnosing ME/CFS, or MDs or Ph Ds involved in clinical research of the illness. Their mandate was to develop a clinical definition that addressed a broader spectrum of the pathogenesis of the illness, as well as to provide diagnostic and treatment protocols for medical practitioners. The members of the panel would have autonomy over their consensus document.

Health Canada selected an Expert Consensus Panel for ME/CFS. The eleven-member Expert Consensus Panel received more than forty nominations including numerous nominations from each stakeholder group. The members of the Consensus Panel represented clinicians, university medical faculty, and researchers in the area of ME/CFS. Collectively, the members of the panel had diagnosed and/or treated more than twenty thousand ME/CFS patients.

Health Canada planned for a Consensus Workshop to be held on March 30 to April 1, 2001. Crystaal (Biovail Pharmaceuticals) funded the workshop without having any involvement with or influence over the Consensus Document. They hired Science and Medicine Canada to organize and facilitate the workshop.

The draft document went through three rounds of revisions prior to the Consensus Workshop where the document received consensus, in principle, with directives for various members to revise some sections. The document was compiled by Marjorie van de Sande and the revised document was sent to the panel. There was 100% consensus by the panel members on the final Consensus Document [1] . The Consensus Document has become known as the “Canadian Consensus Document for ME/CFS”.

 

[alex3619]

Unfortunately Ember this is only an outline. Later on I might go looking for more detail. I guess we might even have to contact one or more of those who developed the CCC to find out. If they had a broad brief, and good experts, then the outcome can work out fine. The CCC shows that. What I want to know goes right down to standards of evidence: how were individual studies evaluated, and what influence did this have on the final outcome. Was it that detailed, that rigorous, or was it more organic?

The modern push for evidence-based medicine has very good reasons to go ahead, but in their haste and the failure to look back at old medical studies properly its becoming a travesty of good process. The example that comes to mind for me is this: not one single psychogenic illness has objective evidence of its existence. The outcomes from CBT/GET were commented on in a Cochrane review, but the extreme subjectivity and potential for bias was ignored. This is what science-based medicine is at least claiming to address. None of the psychogenic hypotheses are scientific. None. Some of the treatment methods could be subjected to scientific analysis, but the PACE trial failed to do this, and it looks like that's off the table for now.

 

[Ember]

Later on I might go looking for more detail.

I don't believe that you're going to find more detail.

 

[WillowJ]

a search on PubMed for "definition" is useful for finding examples from any diseases, but i haven't had the focus to read the full documents when the full text has been available.

 

[Chris]

A couple of points. @Sushi-I did write to three of the signers--got one friendly reply, one very succinct "thanks," and silence from the third. I think now that seeming to invite or even welcome patient approval might in some powerful quarters hinder more than help our researchers. I think writing letters to Sebelius et al, and contacting government figures (as a Canadian that is something I cannot do) would be more helpful. I am also one who wrote in to IOM with a list of nominees, with brief comments on the suitability and qualifications of each--all except one (Julia Newton) taken from the list of signers. I don't think this will have much effect on the IOM, but at least it shows support for those who signed.

I take a very, very dark view of this affair. In conjunction with Dr. Unger's remark that " GE is non-negotiable" (this is a scientist speaking??) I strongly suspect that the insurance lobby ( DSM-V even more than disability) has been successful in invading heavily into many governmental institutions, and the NIH and the CDC, despite moments of apparent forward movement, have given way. The CAA seems to be playing a very dubious game. We desperately need a powerful independent voice. Chris

 

[Ember]

I think writing letters to Sebelius et al, and contacting government figures (as a Canadian that is something I cannot do) would be more helpful.

"Twenty Years and Counting" gives instructions for international members of the community:

For everybody - U.S. and international members of the community:

Please contact the President’s science advisors today and ask them to tell HHS to adopt the CCC and cancel the IOM contract. Directions are below.

Urgent ME Advocacy Action: Ask Congress and the President to Cancel IOM Contract and Adopt CCC!

 

[WillowJ]

Oh it is a great resource. And it's true. It is best to know as much as you can what about as many members of your group think and feel as you can! One reason I feel overwhelmed/late to the issue.

I think, after I responded that little canoe thing bothering me in the back if my head grew to be a big canoe breaking my head open so I wanted to state my feelings on it.

It's such a common pitfall

Edit: I may have not tracked well when reading it. I was focusing on finding bulletin points. I thought that the canoe analogy was Jennie's summary/opinion. Not CAA. Or is Jennie from CAA? This is my biggest weakness in this advocacy effort. I'm not up to speed on the people and details. But I am up to speed in the political situation and the advocacy steps to take in a situation like this.

Sorry, it's a bit confusing. Jennie posted about canoes here and here (and she listed CAA's opinion [the CFIDS Association] with the others, which may be interesting but doesn't influence me, e.g.):

2. The CCC is the place to start. Everyone agrees that CCC should be the starting point for a clinical case definition. The Experts’ Letter, Chu’s letter, and many advocates acknowledge that CCC needs refinement, but advocate for its immediate adoption. PANDORA, Bateman and the CFIDS Association all want to refine and operationalize it prior to adopting it in practice.

Jeanette complained about Jennie's canoe analogy and made one of here own here.

Jennie was on the CAA board for a short time, but is not now.

My post about CAA was not directed to you. Many people have problems with CAA for various reasons, the latest being that letter from CAA asking if the 35 experts wanted to take back their signatures from the position paper stating that CCC was the agreed consensus definition for clinical and research use and the experts should be allowed to make decisions about the disease.

 

[WillowJ]

Just wanted to say, I'm unhappy with CAA's stance on the letters, but I didn't mean to reflect that on Jennie--sorry if it appeared that way. I respect Jennie.