IOM's response to patients' concerns about panel selection

[leela]

Screw this "credibility" crap. We are so long past that and need to MOVE ALONG in getting treatment for frak's sake.
This is total BS. A million sick people need to "prove" themselves? To a bunch of politico-corporate babblers pretending anything they are doing has anything to do with the well-being of real people?

Not to mention, look at us all tearing out our hair just to get CCC acknowledged, when we already know that ICC is better.
How many decades before ICC has "credibility? How many more panels, meetings, and millions? Geez!

This is a goram shell-game and I'm too frakking exhausted to play this pointless scam. Straw men, red herrings, you name it, the cards are stacked every which way. I don't need "credibility" from insurance conglomerates or stale governmental agencies without a clue. I need treatment and I need it yesterday.

Sorry. I had to vent.

 

[leela]

challenge the position of the experts to prove it with the research

Oh this is rich. Give next to nothing for research, (unless it has to do with GET and CBT of course) then "challenge" the experts to "prove it with research". What was I saying about red herrings and straw men? This is *exactly* the tactics abusers use. Gaslighting 101.

 

[alex3619]

@leela, don't apologize. You are right on every point. Its so irrational its not just borderline stupid, it is stupid. Welcome to politics, and we are the political football.

Its a lot like the physics joke about entropy at the moment. Entropy is like a rigged game. You can't win, you can't break even, but you can't get out of the game.

 

[Hermes]

The IOM in some difficulty regarding definition of ME/CFS
Kate Meck, IOM

Dear David,
Thank you for your feedback. All IOM reports follow a strict study process and committees are convened in accordance with this conflict of interest policy to ensure reports provide independent, objective advice. If you would like to be added to the listserv to receive updates on the study, such as when the provisional committee is announced, you may sign up for our listserv here: http://iom.edu/Activities/Disease/DiagnosisMyalgicEncephalomyelitisChronicFatigueSyndrome.aspx.

Best,
Kate Meck

David Egan, ME/CFS advocates and organisations

Dear Kate

Thanks for your reply. I hope we can work together to resolve this issue. There remain issues of conflict of interest, bias, lack of accuracy and consistency, lack of independence, and public interest issues in relation to IOM and its contract to define ME/CFS.

Conflict of interest

IOM itself has a conflict of interest as it is the author and owner of the 5 Reports into GWI below where ME/CFS is extensively mentioned and the IOM’s position on ME/CFS is stated. It’s stated position in these 5 reports creates a conflict of interest, as it failed to include vital biological research findings, some 5,000 papers, and had psychiatric bias in all 5 reports. Further details presented below in synopsis of reports and relevant pages from reports.

Bias

IOM failed to look at the biological research and findings into ME/CFS which amount to approximately 5,000 papers in the 5 Reports into GWI below where ME/CFS is extensively mentioned and the IOM’s position on ME/CFS is stated. Yet the IOM quoted the psychiatric papers, some of which had serious scientific and historical flaws and errors. And the IOM recommended psychiatric based treatments. This strongly indicates psychiatric bias in these 5 reports. Further details presented below in synopsis of reports and relevant pages from reports.

Lack of Accuracy and Consistency

The lack of accuracy pertains to the ignoring and omitting of important biological research and findings into ME/CFS which amount to approximately 5,000 papers in the 5 Reports into GWI below where ME/CFS is extensively mentioned and the IOM’s position on ME/CFS is stated. The omission of Canadian Criteria 2003, Nightingale Criteria 2007, International Consensus Criteria 2011 point to further lack of accuracy. The “primary research” source in these 5 GWI reports failed to include findings of immune dysfunctions, infections of blood, intestines, nervous system and muscles, toxins in the body, HPA axis dysfunctions, autonomic dysfunctions, mitochondria dysfunctions, exercise abnormalities, brain and neurological lesions, inflammation and dysfunctions. The reluctance and refusal to interview medical doctors who have successfully treated ME/CFS also blocked accuracy in the 5 reports.

As regards consistency, the IOM’s position on ME/CFS may become inconsistent if it examines, analyses and includes biological scientific facts in the new definition which were not included in the 5 GWI reports.

Independence

The IOM selected the committees for these 5 GWI reports below where ME/CFS was extensively mentioned and the position on ME/CFS stated. The IOM oversaw these committees, was in regular communication with them and the IOM had the power to read the final report and recommend amendments or changes in line with scientific and medical facts and public interest issues.
The continued selection of committee members with obvious psychiatric bias in 5 GWI committees producing 5 reports, all of them with psychiatric bias strongly suggests a pre-conceived position and viewpoints, a lack of independence and a lack of independent thinking. The latter being obvious through the omission of biological scientific and medical facts.

The Public Interest

There are matters here of great concern to the health and safety of the American people. This is outlined on the following web site detailing those people who have died of ME/CFS and it’s health complications – http://www.ncf-net.org/memorial.htm The neglect of patients through the use of ineffective, useless and harmful psychological treatments and the stigma and prejudice surrounding this in societies has been a major contributor to these deaths and years of suffering.

5 Reports by IOM mentioning ME/CFS and stating their position on ME/CFS from 2000 – 2013

I have only included a brief synopsis of each report and links to relevant pages from the report

Gulf War and Health (2013)
Reeves paper cited and contains several important flaws, including a prevalence figure of 2.54%. Bias in favour of psychiatry in terms of listed and cited research into ME/CFS in the GWI report . Page 22 states that ME/CFS is a somatoform disorder, which is a vague psychiatric illness. Page 97 mentions somatic symptoms. The “primary research” source not included. Primary research should have been included and should have contained findings of immune dysfunctions, infections of blood, intestines, nervous system and muscles, toxins in the body, HPA axis dysfunctions, autonomic dysfunctions, mitochondria dysfunctions, exercise abnormalities, brain and neurological lesions, inflammation and dysfunctions. CFS used out of context in the GWI report and misused to represent every type of known and unknown illness in GWI soldiers. The psychiatric based NICE guidelines were included in the definition along with the outdated Fukuda definition which is vague and imprecise, but the Canadian Criteria (2003) and Nightingale Critera (2007) and International Consensus Criteria (2011) were ignored and excluded. Psychiatric treatments such as CBT, GET and psychiatric drugs were recommended for ME/CFS. ME/CFS biological research papers ignored. Medical doctors with experience in treating ME/CFS patients ignored. Biological medical diagnostics and treatments ignored.
http://books.nap.edu/openbook.php?record_id=13539&page=22

http://books.nap.edu/openbook.php?record_id=13539&page=97
http://books.nap.edu/openbook.php?record_id=13539&page=98
http://books.nap.edu/openbook.php?record_id=13539&page=99
http://books.nap.edu/openbook.php?record_id=13539&page=100
http://www.nap.edu/openbook.php?record_id=13539&page=120

Gulf War and Health (2010)
Wessely cited and Straus cited. Wessely’s 1998 paper contains several important errors. Bias in favour of psychiatry in terms of listed and cited research into ME/CFS in the GWI report . The “primary research” source did not include findings of immune dysfunctions, infections of blood, intestines, nervous system and muscles, toxins in the body, HPA axis dysfunctions, autonomic dysfunctions, mitochondria dysfunctions, exercise abnormalities, brain and neurological lesions, inflammation and dysfunctions. CFS used out of context in the GWI report and misused to represent every type of known and unknown illness in GWI soldiers. ME/CFS biological research papers ignored. Medical doctors with experience in treating ME/CFS patients ignored. Biological medical diagnostics and treatments ignored. Canadian Criteria (2003) ignored.
http://www.nap.edu/openbook.php?record_id=12835&page=210
http://www.nap.edu/openbook.php?record_id=12835&page=211
http://www.nap.edu/openbook.php?record_id=12835&page=212
http://www.nap.edu/openbook.php?record_id=12835&page=213
http://www.nap.edu/openbook.php?record_id=12835&page=214

Gulf War and Health (2008)
Wessely cited and Straus cited. Wessely cited and Straus cited. Wesselys’ 1998 paper contains several important errors. Bias in favour of psychiatry in terms of listed and cited research into ME/CFS in the GWI report . Telephone and mail shots used as “primary research” source. The “primary research” source did not include findings of immune dysfunctions, infections of blood, intestines, nervous system and muscles, toxins in the body, HPA axis dysfunctions, autonomic dysfunctions, mitochondria dysfunctions, exercise abnormalities, brain and neurological lesions, inflammation and dysfunctions. CFS used out of context in the GWI report and misused to represent every type of known and unknown illness in GWI soldiers. ME/CFS biological research papers ignored. Medical doctors with experience in treating ME/CFS patients ignored. Biological medical diagnostics and treatments ignored. Canadian Criteria (2003) ignored.
http://www.nap.edu/openbook.php?record_id=11922&page=174
http://www.nap.edu/openbook.php?record_id=11922&page=175
http://www.nap.edu/openbook.php?record_id=11922&page=176
http://www.nap.edu/openbook.php?record_id=11922&page=177
http://www.nap.edu/openbook.php?record_id=11922&page=178

Gulf War and Health (2006)
Wessely cited and Straus cited. Wesselys’ 1998 paper contains several important errors. Bias in favour of psychiatry in terms of listed and cited research into ME/CFS in the GWI report . The “primary research” source did not include findings of immune dysfunctions, infections of blood, intestines, nervous system and muscles, toxins in the body, HPA axis dysfunctions, autonomic dysfunctions, mitochondria dysfunctions, exercise abnormalities, brain and neurological lesions, inflammation and dysfunctions. CFS used out of context in the GWI report and misused to represent every type of known and unknown illness in GWI soldiers. ME/CFS biological research papers ignored. Medical doctors with experience in treating ME/CFS patients ignored. Biological medical diagnostics and treatments ignored. Canadian Criteria (2003) ignored.
http://www.nap.edu/openbook.php?record_id=11729&page=161
http://www.nap.edu/openbook.php?record_id=11729&page=1612
http://www.nap.edu/openbook.php?record_id=11729&page=163
http://www.nap.edu/openbook.php?record_id=11729&page=164
http://www.nap.edu/openbook.php?record_id=11729&page=165

Gulf War and Health: Volume 1. Depleted Uranium, Pyridostigmine Bromide, Sarin, and Vaccines (2000)
Wessely cited and Straus cited. Wesselys’ 1998 paper contains several important errors. ME/CFS assumed to be a somatoform disorder.
http://www.nap.edu/openbook.php?record_id=9953&page=343
Quotation from report http://www.nap.edu/openbook.php?record_id=9953&page=343
“ The recognition of a new disease is far from straightforward (Wegman et al., 1997). The simplest statement is that it is a process (Kety, 1974), often taking years. The purpose of the process is to demonstrate that patients are affected by a unique clinical entity distinct from all other established clinical diagnoses. The individual “steps” for gathering and interpreting evidence are not clear-cut. Evidence from biomedical research plays a prominent, but not necessarily exclusive, role in defining and classifying a new disease. Social factors, including culture and economics, influence the recognition, classification, and definition of a new disease (Rosenberg, 1988; Aronowitz, 1998; Wessely et al., 1998).”
This is contradicted by the way that ME/CFS and Fibromyalgia has been recognised and classified by some psychiatrists. Recognising and classifying a new disease is very straightforward for some psychiatrists, they just term it a psychiatric illness and in some cases give it a new definition and classification to suit their own purposes. They even create a competing definition of their own in order to take over an illness. And they conveniently ignore all the biological and biomedical evidence which prove its not a psychiatric illness. Several physical illnesses were wrongly classified as psychiatric in the past, but have since been proved to be physical and biological illnesses not psychiatric.
http://www.nap.edu/openbook.php?record_id=9953&page=350
http://www.nap.edu/openbook.php?record_id=9953&page=354
http://www.nap.edu/openbook.php?record_id=9953&page=355

Yours Sincerely
David Egan.

 

[alex3619]

Social factors, including culture and economics, influence the recognition, classification, and definition of a new disease (Rosenberg, 1988; Aronowitz, 1998; Wessely et al., 1998).

Actually this quote is right, though I suspect I am using it out of context. Acceptance of new disease is based as much on cultural, political and economic criteria as science. Yet its hypocrisy to claim that the resulting definition is scientific, and often hypocritical to claim its evidence based.

Almost the entirety of the DSM is consensus based from a small handful of psychiatrists using the existing evidence base, where subjective interpretation and evidence is taken as evidence. Testing definitional validity is more opinion. Nowhere does it ground out in science with objective measures.

Its precisely because cultural, political and economic influence has stuffed up the research and priority on research into ME that we are in this mess.

So the statement is accurate, but its meaning should be taken (in my view, without their context) that the social factors are stuffing things up. Get out of the way and do some real science!

 

[leela]

So the statement is accurate, but its meaning should be taken (in my view, without their context) that the social factors are stuffing things up. Get out of the way and do some real science!

Amen to that, brother.

 

[justinreilly]

They do not write cancer studies with 75% cancer experts and 25% non-oncologists. Again, there is no reason we should accept more than 1 non-expert (e.g. a statistician) on the task force. This is simply not customary--it is not done at all (except in very badly disrespected diseases and it is a sign of disrespect)--and we do not have to put up with it.

Willow, I agree with you. This makes sense and that is my understanding also about how diagnostic criteria are formed. I am wondering if you or anyone has a cite for this proposition. I tried to do google searches but i couldn't turn up anything about how diagnostic criteria or case definitions are normally formulated.

Of course we have the quote from IoM that GWI and ME are the only diseases in memory it has been asked to define. But we could use backup for the broader proposition you stated.

 

[justinreilly]

Alex, your posts on EBM are great. They informed, intrigued, and totally confused me. There is so much for my little brain to learn to be able to understand the EBM and diagnostic criteria formulation situation, much less explain it to someone else! But reading your posts was a great start, pls keep it up! I am realizing now asking you for cites may be too much, but pls keep explaining as you are able.

 

[alex3619]

@justinreilly, maybe I will go looking for some great existing articles, compile a list, and put it somewhere. There is so much to learn.

 

[Nielk]

When we met with IOM person when we happened to be in DC for other reasons, we expressed to lady who will not oversee the study and Kate who will work to handle much of the legwork that we would like to see 50% ME//CFS clinical experts, 25% ME/CFS experts and the last 25% be representatives from medical professional organizations, such as the AAN (neurology) and others. It was explained to us that there will definitely be ME/CFS clinical experts. But the non experts being there, but knowing that type of science, means they can challenge the position of the experts to prove it with the research. So, that is why their reports carry more credibility than a bunch of people who are of same experience and coming in similar opinions. It's a type of internal peer review process. Also, remember that the committee's report must go through an external peer review process.

You make it sound like only clinicians who have no experience with ME/CFS know science!

 

[Snow Leopard]

Would I want to see only ME medical experts on the panel?

No, I'd like to see experts from fields such as infectious disease, autoimmune disorders etc.

What I don't want to see is more "chronic pain" or Fibromyalgia etc. experts.

 

[taniaaust1]

Ultimately, the diagnostic criteria recommended by the committee will be used by physicians/clinicians with and without experience in ME/CFS, so the participation of committee members from both perspectives is very important.
Best,
Kate Meck”

That is quite actually insulting towards our experienced clinicians/physicians. It implies that they believe our experts couldnt do a diagnostic criteria good enough for non experts to use.

I personally think that those wanting OMI to do this, think the canadian definition is too complex and they are wanting something way easy eg to ignore most of the symptoms we have with this illness. There seems to be a reluctance to accept how complex our illness is.

Though it would be rather good I think to hear what it is you do want - not you specifically - by way of a 2013 CFS/ME Guideline for the USA even if the CCC forms the backbone of it.

I think some thought needs to be put into that too. Why would it be good for the USA to have "their own" definition of ME/CFS?. It is already the case of too many definitions out there.. just imagine if every country wanted their own definition!!! (that certainly dont help science).

What is really needed is one to be accepted worldwide, right now the CCC is the closest one to achieving that I think and if it could be adopted in America it will be getting much closer to achieving a world wide one (the CCC is already partly adopted in Australia, my state recognises it and opted to keep it.. along with the Australian definition one when that one was done).

 

[taniaaust1]

When we met with IOM person when we happened to be in DC for other reasons, we expressed to lady who will not oversee the study and Kate who will work to handle much of the legwork that we would like to see 50% ME//CFS clinical experts, 25% ME/CFS experts and the last 25% be representatives from medical professional organizations, such as the AAN (neurology) and others. It was explained to us that there will definitely be ME/CFS clinical experts.

But the non experts being there, but knowing that type of science, means they can challenge the position of the experts to prove it with the research. So, that is why their reports carry more credibility than a bunch of people who are of same experience and coming in similar opinions. It's a type of internal peer review process.

Also, remember that the committee's report must go through an external peer review process.

That last sentence certainly brings no comfort to me. I can imagine the external peer review process being done by Dr Wessely and his Wessely schooler buddies. The odds of something like that are fairly great even if they arent calling in reviewers from overseas.. still many Wessely schoolers other places too.

 

[alex3619]

Trying to reduce complexity, wish it away, or ignore it is dangerous. The same goes for uncertainty.

There have been attempts to do similar things, simplifying the laws of nature as it were, for a long time. One of the most famous was an attempt to pass through Indiana legislature the bill that the number pi be mandated by law to be 3.2 though other options were mentioned.

http://en.wikipedia.org/wiki/Indiana_Pi_Bill

Reality is complex. Uncertainty is involved in almost everything. Until we learn how to deal with that, and not dismiss it, then we are not working in the real.world.

When this applies to medical decisions affecting the lives of millions ... its creepy even thinking about it.

ME is as complex as it is. Medical professions need clear directions, what they don't need is expositions of ignorance.

 

[Ember]

Trying to reduce complexity, wish it away, or ignore it is dangerous. The same goes for uncertainty....

Reality is complex. Uncertainty is involved in almost everything. Until we learn how to deal with that, and not dismiss it, then we are not working in the real.world....

ME is as complex as it is. Medical professions need clear directions, what they don't need is expositions of ignorance.

The competence of clinical experts is needed in approaching and understanding as complex a disease as ME. Dr. Carruthers has warned against producing long symptom lists and symptom counts:

Confusion reigns about what we mean by complexity itself in various realms (the topic itself is complex) - and we are dealing with the realm of medicine, where not much serious thought has been put to it as yet, e.g. producing long symptom lists and symptom counts doesn’t help.

Simple or Complicated structures have a known stable causal structure, of variable intricacy, that hence are predictable if you can extrapolate from knowledge garnered from one astute observation. Complex structures do not, as their causal structure is forever recursively changing - as a result of the causal interaction of their constituents - and hence are inherently unpredictable. As a consequence a complex structure must be observed continually, while the complicated one does not have to be, while confirming/disconfirming inferences, tests, and imagings are made. For complex diseases the only observer who is constantly observing the patient is the patient her/himself. We all must learn to utilize this kind of continual common sense self-observation by patients in dialogue with their physicians, as we together observe the development of complex diseases over real time through a robust and productive doctor/patient relationship. This will entail a large qualitative shift in attitude and appreciation of the value of the direct self observation of illness structure as it evolves in real time, if done properly - and without diversion into cognitive dualisms.

Even the SOW acknowledges that ME/CFS is a complex disorder or disease.

 

[WillowJ]

When we met with IOM person when we happened to be in DC for other reasons, we expressed to lady who will not oversee the study and Kate who will work to handle much of the legwork that we would like to see 50% ME//CFS clinical experts, 25% ME/CFS experts and the last 25% be representatives from medical professional organizations, such as the AAN (neurology) and others. It was explained to us that there will definitely be ME/CFS clinical experts. But the non experts being there, but knowing that type of science, means they can challenge the position of the experts to prove it with the research. So, that is why their reports carry more credibility than a bunch of people who are of same experience and coming in similar opinions. It's a type of internal peer review process. Also, remember that the committee's report must go through an external peer review process.

BTW, Tina, thanks for the information about what they are thinking.

I do think it would be nice to add other people to the field if they were the right people, as I mentioned in my post #44, but as I said I doubt the ability of IOM to approve them. Also I doubt the wisdom of doing that in a context of a low-budget tight-deadline definition effort, particularly one that expects a consensus result.

 

[WillowJ]

Willow, I agree with you. This makes sense and that is my understanding also about how diagnostic criteria are formed. I am wondering if you or anyone has a cite for this proposition. I tried to do google searches but i couldn't turn up anything about how diagnostic criteria or case definitions are normally formulated.

Of course we have the quote from IoM that GWI and ME are the only diseases in memory it has been asked to define. But we could use backup for the broader proposition you stated.

a PubMed search would yield examples. I couldn't find a "this is the policy", either, but if someone wants to write AMA, I bet they tell you the same.

 

[Gemini]

Willow, I agree with you. This makes sense and that is my understanding also about how diagnostic criteria are formed. I am wondering if you or anyone has a cite for this proposition. I tried to do google searches but i couldn't turn up anything about how diagnostic criteria or case definitions are normally formulated.

Justin,

You might look at how the disgnostic criteria for MS was developed by an international panel of experts in conjunction with the MS Society. In 2001 it was called the "McDonald Criteria" & has been revised several times over the years:

www.msdiagnosed.org/McDonald.pdf

Revised in 2010:

http://onlinelibrary.wiley.com/doi/10.1002/ana.22366/pdf

www.ncbi.nlm.nih.gov/pubmed/21387374

The names & affiliations of the international MS panel of experts are given in these citations.

This process is similar to the ME/CFS panel of experts that developed the ICC isn't it?

 

[Andrew]

How do they decide if someone is an expert?

 

[Gemini]

How do they decide if someone is an expert?

ICC International Panel (ICC Primer pg ii):

"An International Consensus Panel, consisting of clinicians, research investigators, teaching faculy, and an independent educator, represent diverse backgrounds, medical specialties and geographical regions. Collectively the members of the panel have:

* diagnosed and/or treated more than 50,000 patients;
* more than 500 years of clinical experience;
* approximately 500 years of teaching experience;
* authored hundreds of peer-reviewed publications, as well as written chapters and medical books; and
* several members have coauthored previous criteria.

Panel members contributed their extensive knowledge and experience to the development of the International Concesus Criteria and this Primer..." Bold mine.