• Welcome to Phoenix Rising!

    Created in 2008, Phoenix Rising is the largest and oldest forum dedicated to furthering the understanding of and finding treatments for complex chronic illnesses such as chronic fatigue syndrome (ME/CFS), fibromyalgia (FM), long COVID, postural orthostatic tachycardia syndrome (POTS), mast cell activation syndrome (MCAS), and allied diseases.

    To register, simply click the Register button at the top right.

Dr. Ellie Stein against IOM contract

Ember

Senior Member
Messages
2,115
“I gave my signature but it somehow didn’t get included on the final copy of the letter.”

http://www.mecfsforums.com/index.php/topic,18046.0.html
To: undisclosed-recipients:
Subject: Please support the consensus against developing yet another definition for ME/CFS

On September 23, the department of Human Health Services in the US announced that it will begin working on the initiative with the Institute of Medicine (IOM) to begin work to develop new “clinical diagnostic criteria” for ME/CFS. That announcement can be found here: http://news.silobreaker.com/httpbitly18m7xlj-11_635868171

The same day, a large group of the leading researchers and clinicians in the field of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) sent an open letter to Health and Human Services Secretary Kathleen Sebelius supporting the use of the Canadian Consensus Criteria (CCC) as the research and clinical case definition for ME/CFS.

I gave my signature but it somehow didn’t get included on the final copy of the letter. We are calling for HHS to follow our lead by using the CCC as the sole case definition for ME/CFS in all of HHS’s activities related to the disease and strongly urged HHS to abandon its plans to contract the Institute of Medicine who has no knowledge or experience with ME/CFS to develop new clinical diagnostic criteria.

Although this action by the US Government is American, if another definition of ME/CFS is developed by people who have no expertise in the field, it will add to the confusion world wide about how to diagnose ME/CFS and it will affect us here in Canada. Please support the CCC by signing the petition at the link below and spreading the word to your networks.

The Sept 23, 2013 open letter from ME/CFS researchers and clinicians to Secretary Sebelius can be found here: http://bit.ly/15npS9B

A world wide petition against this effort can be found at: http://www.thepetitionsite.com/898/238/310/thank-you-to-mecfs-experts/

Ellie Stein
Eleanor Stein MD FRCP(C)
Psychiatrist in Private Practice and
Assistant Clinical Professor, University of Calgary
4523 16A St. SW
Calgary, AB T2T 4L8
Ph: 403 287-9941
 

Ember

Senior Member
Messages
2,115
As a Canadian, I had to laugh when I read David Egan's further fallback position for dealing with the IOM contract:
Further fallback position would involve patients and patient organisations making a joint unified decision to reject the psychological definition of the IOM and deciding to only accept the CCC 2003 and ICC 2011 and sub-contracting outside the USA to get diagnosis and treatments. This would involve buying foreign health insurance and going to a nearby country using CCC 2003 and ICC 2011.
But Dr. Stein's observation here is no laughing matter: "Although this action by the US Government is American, if another definition of ME/CFS is developed by people who have no expertise in the field, it will add to the confusion world wide about how to diagnose ME/CFS and it will affect us here in Canada."

Dr. Stein urges Canadians to sign “a world wide petition against this effort,” but she provides a link to thank the ME/CFS experts for their letter instead. The petition against “this action by the US Government” is found here.
 

alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
I have been thinking of damage mitigation quite a bit, but I don't usually mention it as the main goal is to stop the IOM.

In one specific sense, the idea of accepting ICC and CCC and not accepting IOM makes sense, but it has nothing much to do with patients. Its about the researchers.

Those with private funding can probably adopt CCC or ICC and bypass the IOM, producing the focused research we want.

Those with public funding, especially from HHS, may be constrained to use the IOM definition. However they can still subgroup/reclassify, including using the CCC. When bad, lackluster or useless data comes out of the group defined by IOM, and good data comes out of the group defined by CCC, then it will show up the IOM definition as useless.

Finally there is the issue that any future definition related to the IOM definition might be mandatory in funding studies, and then used to prevent funding to studies that violate this. However our researchers can use this definition, then rework the data so that only CCC or ICC patients are concluded, and publish a separate study.

I am well aware that the research definition and the clinical definition are different. However in any clinical trial the IOM definition might be used (e.g. as Oxford is used in UK studies) if its "operationalized" for use like that. Further, any IOM definition might strongly influence a future new research standard. Also, confusion or conflating between a research and clinical definition might bias the granting of funds to studies.

An additional fallback position is the research definition. We need to be sure that is right, and not permit poor research standards to be used in defining it.

The ultimate fallback position is to push for verification of our possible diagnostic tests, then for transition to commercial use, then we start using them, bypassing the IOM entirely.
 

Ember

Senior Member
Messages
2,115
Further, any IOM definition might strongly influence a future new research standard. Also, confusion or conflating between a research and clinical definition might bias the granting of funds to studies.

An additional fallback position is the research definition. We need to be sure that is right, and not permit poor research standards to be used in defining it.
The clinical and research definitions are being worked on simultaneously, and influence between the two processes is mandated. In the Statement of Work, the IOM committee is instructed to “communicate and coordinate with the Office of Disease Prevention at NIH regarding their ongoing Evidence- based Methodology Workshop for ME/CFS in an effort to minimize overlap and maximize synergy.” The SOW further stipulates that “the coordination with NIH should assure that relevant information is shared and that key messages are coordinated.”

Jennie Spotila writes concerning the research definition, “The problem here is that we don’t have enough information to judge the EbMW process, since we don’t know who is on the organizing committee. We can’t judge the case definition process, since we have absolutely NO information about it whatsoever. “
 

alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
Yes, we are operating in a vacuum. That has to change if they hope to get us to trust them, and its likely that its too late for that to happen. What we do know is the outcome of two prior evidence-based reviews, one by IOM on CMI (as they now call it, formerly Gulf War Ilness) and one on CFS (Oxford) from the UK's NICE that was looking at treatment recommmendations. Evidence-based can be buzzword for culling any science they do not like, by downplaying, excluding or demoting its value.