ME/CFS Experts Reject Federal Effort to Produce Definition
A sleeping tiger just woke up.
On the same day the Department of Health and Human Services (DHHS) announced, in the face of strenuous opposition, that they’d entered into a contract with the IOM to produce a clinical definition for ME/CFS, the ME/CFS professional community reared it’s head and emphatically rejected that effort, endorsing the Canadian Consensus Criteria.) (Significantly, that group included Dr. Lenny Jason, some of whose studies had raised questions about the CCC.)
The Feds decision to include the IOM, a group without experience in ME/CFS (or in creating definitions), to tackle one of the most sensitive issues in ME/CFS, displayed hubris, ignorance and tone-deafness. It’s hard to imagine this happening under the watch of the prior DHHS liasons, Dennis Mangan and Wanda Jones, both of whom made efforts to engage the ME/CFS community (and are still engaged with it).
Most of the big names – Klimas, Peterson, Bateman, Snell, Lerner, Jason, Enlander, Broderick, Chia, De Meirleir, etc. signed the letter strongly endorsing the CCC, and warned that not using it will harm patients, impede research efforts and efforts to find biomarkers.
“As leading researchers and clinicians in the field, however, we are in agreement that there is sufficient evidence and experience to adopt the CCC now for research and clinical purposes, and that failure to do so will significantly impede research and harm patient care.”
The experts echoed ME/CFS advocates concerns about lack of expertise at the IOM
“We strongly urge you to abandon efforts to reach out to groups such as the Institute of Medicine (IOM) that lack the needed expertise to develop “clinical diagnostic criteria” for ME/CFS.”
They even suggested the effort could move the field backwards
“Worse, this effort threatens to move ME/CFS science backwards…”
Who could blame them for thinking that? The fact that the IOM contract process was done in secret, and that the federal advisory committee was prohibited from speaking out on this topic made everyone’s hair stand on end. The last major federal effort to produce a definition – the Empirical Definition – brought ME/CFS experts in at the front-end, only to have a small team of CDC staff develop a definition that shocked virtually everyone. Perhaps the DHHS admins, new to this field, should have done a little research on how that turned out.
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With warning flags sprouting up like mushrooms at the IOM’s Gulf War Definition project, the ME/CFS experts were not in a trusting mode.
Indeed, the Feds and ME/CFS experts have been on separate courses with ME/CFS experts developing two definitions (CCC and ICC) , and the Feds developing one (Empirical definition), which couldn’t have been more different. Something had to crack at some point and it has; an open rift has developed between the ME/CFS experts and the DHHS
The DHHS is essentially encircled with a small group of administrators bucking the wishes of both ME/CFS experts and advocates. What they’ll do is entirely unclear. They brushed aside advocates appeals without once reaching out to them but having a significant part of the ME/CFS research and physician community allied against you is another deal entirely. Plus they still have a research definition project to deal with.
Some Groups Hold Back
The CFIDS Association of America has a bit more faith; while explicitly stating the need to operationalize the CCC in any new definition, the CAA did not join either the ME/CFS advocates or the experts efforts.
The CFIDS Association believes that any review of current clinical diagnostic criteria should include requirements to validate and operationalize the Canadian criteria
The slow-moving IACFS/ME did not join the letter and neither has its President, Dr. Fred Friedberg.
The way this has played out is a shame. A federally sponsored definition could be a major achievement (say bye-bye Fukuda, hello to postexertional malaise), and the IOM could have produced a definition that moved this field forward; the problem is nobody trusts outside experts on this topic, and the DHHS’s heavy-handed approach has alienated the ME/CFS community.
For now advocates and patients need to endorse the effort to overturn the contract. More on that later.
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I’ve latterly come to be a little distrustful of ‘strict’ ME/CFS definitions, increasingly the CCC has seemed to me to be a smorgasbord of each ‘star’ researcher’s pete expertise or research interest regardless of whether or not findings have been consistent or fitted into any cohesive model. I also has reasons to be wary for reasons discussed in this blog :
Essentially, for what I feel is a primarily neurological disorder, excluding those with ‘psychiatric’ symptoms such as anxiety and depression could exclude key pointers to the underlying pathology.
Consequently I was rather relieved (and told him so) that Jason found an increased rate of ‘psychiatric illness’ in CCC cohorts.
BUT … despite these reservations, I do believe this is a positive development.
If I recall correctly, during the development of the UK NICE guidelines on ME/CFS (in the UK National Health Service NICE recommendations generally determine how the medical profession views and treats an illness) they relied heavily on a review of the ME/CFS literature carried out by an ‘independent’ consultancy group (York?).
No doubt they worked out an apparently rational “weighting and scoring’ scheme to be able to sort out the research wheat from the chaff based on criteria such as methodology (RCTs being the ‘gold standard’), sample size, replication, money spent? etc etc. The end result of course being that most of the small scale unreplicated biological ME/CFs research was discarded as low quality.
No doubt in a similar ‘objective’ exercise, the large, well funded, gold-standard PACE trial would trump everything else regardless of any real world validity.
So thumbs up to these practitioners for taking a stand against what could be the worst option. As long as they do so bearing in mind that a ‘consensus’ doesn’t mean its right.
Man did you hit the nail on the head…
The end result of course being that most of the small scale unreplicated biological ME/CFs research was discarded as low quality.
That’s exactly what happens when outside experts are brought in; they focus on the big rigorous studies – many of which are behavioral studies – and discard the little studies. That’s why we need anecdotal evidence from physicians (and the small studies) to be included.
OH NO, is this the beginning of the same kind of problems that are daily encountered with Lymes Disease? If so, I should put a down payment on my funeral arrangements. I have them all! Believe me they are not one and the same. Why doesn’t the government get with it and involve the doctors and researchers and patients that are intimately involved with the subject? It’s appalling, disheartening and blatantly evident that the government’s departments and whomever is running them are idiots and should be considered for an early retirement.
These problems have pervaded the ME/CFS community since the Fukuda definition was developed in 1994. :)…It appears we have alot in common…
Here is the notice sent out from DHHS regarding the IOM contract
We are pleased to announce that the Institute of Medicine (IOM) will begin conducting a study on Diagnostic Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome this month. This study grew out of the 2012 CFSAC recommendation to the Secretary to convene a workshop to “reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS.” Because the use of and audience for case definitions for research and clinical care are very different, HHS decided that separate processes were needed to develop them. The NIH is convening an Evidence-based Methodology Workshop process that will consider case definitions appropriate for ME/CFS research and the IOM will address the clinical diagnostic portion of the recommendation.
The Office on Women’s Health/HHS is co-sponsoring the IOM study with several agencies that participate in CFSAC. A group of voting and non-voting members of the committee participated in the development of the Statement of Work.
The IOM has agreed to perform the following tasks over the next 18 months:
· Conduct a study to identify the evidence for various diagnostic clinical criteria of ME/CFS using a process with stakeholder input, including practicing clinicians and patients;
· Develop evidence-based clinical diagnostic criteria for ME/CFS for use by clinicians, using a consensus-building methodology;
· Recommend whether new terminology for ME/CFS should be adopted;
· Develop an outreach strategy to disseminate the definition nationwide to health professionals.
To accomplish these tasks, the IOM has also agreed that:
· the IOM committee will include approximately 15 members with expertise in the following areas: epidemiology; clinical medicine/primary care and other health care fields, particularly with expertise in ME/CFS, including neurology, rheumatology, immunology, pain, infectious disease, behavioral health, cardiology, endocrinology; and scientists and physicians with experience in developing clinical case definitions. The IOM will ask interested parties, including expert clinicians, researchers and patient advocates, to make suggestions for nominees to the committee.
· the IOM, in addition to the committee meetings, will sponsor open meetings to enlist the comments and concerns of patients, family members and other caretakers, health educators, health care professionals, and advocacy groups. During these meetings, an open phone line and email address will be available to those who cannot attend in person.
· as the committee reviews the literature, efforts that have already been completed on this topic area will be considered, 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. In an effort to minimize overlap and maximize synergy, the committee will seek input from the NIH Evidence-based Methodology Workshop for ME/CFS.
· the committee will distinguish between disease subgroups, develop a plan for updating the new criteria, and make recommendations for its implementation. Any recommendations made by the committee will consider unique diagnostic issues facing people with ME/CFS, specifically related to: gender, across the lifespan, and specific subgroups with substantial disability.
HHS is proud to be making this investment in ME/CFS. We have heard the advocates’ concerns and trust that many have been addressed by the information provided in this email. It is our hope that a widely accepted clinical definition and a clear distinction from case definitions for clinical trials and research will aid in advancing clinical care, drug development, and basic translational research for ME/CFS.
The CFSAC Support Team
Based on this most recent response put out by HHS, I’m just double-checking that I’m reading it correctly. Isn’t this essentially what the patients and advocates wanted? It looks so to me. To include a plan or dissemination of information to physicians currently in practice and hopefully to hasten the teaching of ME in our medical universities. I’d like to thank all and anyone who came up with what appears to be a comprehensive approach and one that includes the expertise of many, including the patients themselves.
Dr. Sebelius and Dr. Unger, THANK YOU! This is a long time coming for so many of us who have been so very debilitated for many years now. I look to my future with hope. Hurry up with the EIGHTEEN months!!!
I just wanted to remind everyone that the CCC or Canadian Consensus Criteria is not the name of the document which was created by both Canadian and International experts in the field.
In the originial Journal of Chronic Fatigue Syndrome, it is called the Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Clinical Working Case Definition, Diagnostic and Treatment Protocols – A Consensus Document.
The Overview document is called Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome: A Clinical Case Definition and Guidelines for Medical Practitioners – An Overv iew of the Canadian Consensus Document.
The CCC has become a well-used nickname of sorts and I hope it has not created a bias in Government or in advocacy. These words may lead to a misperception and I believe it has.
A much more impressive title. Thanks Valerie.
Great job on reporting this so quickly Cort. This letter is the best news we’ve heard in a long time and I am so grateful to all those who signed their names to it. I thank them for their continued dedication to us and applaud their courage to voice their objections so strongly and concisely. Hearing from the experts themselves gives us the encouragement we need to continue in our advocacy efforts.
Yes – this post sums it up for me. I would also like to add that I phoned in a thank you directly to my physician for being willing to sign the letter. It’s a happy day.
It’s pretty rare that the ME/CFS experts step in for sure and I agree it provides a boost. Hopefully the DHHS will feel compelled to consult with the experts at every step of the process.
How much upset and angst could have been avoided it the Feds had chosen to do that earlier…
Actually if the Balkanized researcher community had come together like this earlier things might also be different!
My sentiments exactly!
“…efforts that have already been completed on this topic area will be considered, 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.”
–>> the 2007 NICE Clinical Guidelines ????
There are so many things about this whole process that I find deeply troubling, but having them “consider” the NICE Guidelines sends up major red flags and scares the heck out me.
Is that a big ol’ shaft I see headed our direction?
Why am I not surprised? I doubt the US gov’t really wants to solve this, the research and costs of treatment with future “free” healthcare does not add up!!
Does anyone remember how/why the name CFS came about? Was it not the big Insurance & Gov’t not wanting to pay disability dollars? The CCC criteria helps the medical profession to diagnose ME which describes our condition more accurately.
Consensus is not science. We see this phenomenon mainly in psychology.
According to there statement the HHS wants to help patiënts. However, I read a political statement. In practice, all objective studies published would be dismissed as too small and unconfirmed. Then only remains cognitive behavioral therapy as evidence-based therapy. While evidence based is no objective science. Bias plays a big role. This also applies to the development of new criteria. This disease is so complex, with different causes and symptoms there is no single solution. The only consistency for this disease -in an objective sense- is a repeated exercise- and NK cell function test. I hope they will use these tests.
“-The IOM has agreed to perform the following tasks over the next 18 months:…”
This is the whole point. Another way to delay, delay, delay. That this work was done years ago and is readily available RIGHT NOW, yet the government claims it needs to do this BEFORE any meaningful work can be done is evidence that it really doesn’t want any meaningful research on this illness done for as long as it can delay, delay, delay.
The rest of the proposal looks good, but the point is, it’s entirely unnecessary — the work has already been done and is available now.
I would hope that each of the signers of the protest letter would nominate five of his/her peers who signed the protest letter so that each of those 35 REAL experts (there is no such thing as an “outside expert” in mecfs) would be nominated several times. Then we can wait for the excuses for why the real experts were not invited to this IOM party. Yeah, we can wait 18 months for more of the same: The illusion of progress instead of real progress.
This is more smoke and mirrors from the US health bureaucracy. The IOM has agreed to delay, delay, delay.
Cort, that is one heck of a beautiful and mean looking tiger… No one in their right mind should mess with it! I hope that is how the HHS and the IOM feel right now…
Its going to be 18 months for us to see if this decision will be good or not. I am fearful, but this could be a good thing. I am hopeful, because they surely would not drag the ME/CFS Community through 18 months of nonsense, without knowing that IF they did, their would be such an outcry from the community, that we would be ignored no more. I would be willing to sit out at a rally in Washington in a wheelchair all day for days, until I fainted or needed IV fluids, or start a ME/CFS Fast/Not eat until theres change. Sounds harsh I know but, I don’t have much life left, and this is not quailty. Might as well make a difference.
such a way of wasting money and time
30 yrs after the northamerican epidemics, still struggle with definition
The thing that concerns me is inclusion of the ongoing CDC (flawed empirical definition–unstated) data and the NICE guidelines. How can we hope for any good to come from all this effort if they’re including those sources of extremely flawed info?
If I had enough energy I’d shriek until I lost my voice. (It’d probably take about 3 minutes.)
Cort, what is your take on this whole IOM issue? On PR we are trying to band together to fight this. We have sent letters etc.. but we need something more.
Knowing that the Gulf War vets protests didn’t stop the IOM contract from going through seem scary. Can we stop this or be acknowledged that we don’t want it to go through?
Id appreciate your thoughts.