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International experts speak out against the IOM contract to determine clinical diagnostic criteria

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Mary Dimmock reviews a most welcome announcement from our expert clinicians and researchers who have urged HHS to adopt the Canadian Consensus Criteria and save money by cancelling the contract with the Institute of Medicine...

On September 23, 2013, the US Department of Health and Human Services announced that it had entered into a contract with the Institute of Medicine (IOM) to begin work to develop “clinical diagnostic criteria” for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).

But wait, there’s more...

Stop the press!

On the same day, 35 of the leading international researchers and clinicians in the field of ME/CFS have written an open letter to Secretary Kathleen Sebelius to announce that they have reached a consensus on adopting the Canadian Consensus Criteria (CCC) as the research and clinical case definition for ME/CFS.

Our experts called for HHS to follow their lead by using the Canadian Consensus Criteria as the sole case definition for ME/CFS in all of HHS’s activities relating to the disease, and strongly urged HHS to abandon its plans to reach out to groups like the Institute of Medicine to develop clinical diagnostic criteria.

Acknowledging that the case definition will be refined as science advances, the authors unambiguously endorsed the CCC as the baseline criteria, stating:

“The expert biomedical community will continue to refine and update the case definition as scientific knowledge advances, for example, this may include consideration of the 2011 ME International Consensus Criteria … 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.”

Just as directly, the authors stated their strong opposition to the IOM initiative, stating:

“We strongly urge [HHS] 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. Since the expert ME/CFS scientific and medical community has developed and adopted a case definition for research and clinical purposes, this effort is unnecessary and would waste scarce taxpayer funds that would be much better directed toward funding research on this disease. Worse, this effort threatens to move ME/CFS science backward by engaging non-experts in the development of a case definition for a complex disease about which they are not knowledgeable.”

Wow! Could our experts have spoken any more clearly, loudly and collectively?

More than any other issue, HHS’ decades long failure to adopt a definition that actually reflects our disease has confounded research and forestalled drug development. It has caused doctors to dismiss their patients’ illness or attribute it to depression. It has bred the widespread stigma and misunderstanding that ME/CFS patients face every day. By its actions, HHS has abandoned ME patients to lives of terrible debility and suffering with no treatments, no care and no hope that anything will ever change. In the face of such suffering, some patients have chosen suicide.

Compounding its mistakes, HHS unilaterally entered into a contract with the Institute of Medicine (IOM) to develop clinical diagnostic criteria and has repeatedly stated its intent to use non-experts to define our disease. We need only look to the Gulf War Illness experience with the IOM and the resulting “Chronic Multisymptom Illness” to know that this would be disastrous.

But today, thanks to our experts, the time for pretending ME/CFS doesn’t exist is OVER! The time for burying this devastating disease inside of an illegitimate collection of unexplained fatiguing illnesses is OVER! To quote advocate Tom Hennessey, “NO MAS!”

HHS can no longer claim that there is a lack of consensus amongst disease experts. As with every other disease, it is time for HHS to follow the lead of our disease experts and adopt the Canadian Consensus Criteria for research and clinical purposes. In particular, HHS must now stop wasting taxpayer dollars on misguided efforts that, in the words of the letter authors, “threaten to move ME/CFS science backwards.”

For patients who have suffered through years of studies into “false illness beliefs” and maladaptive coping styles, this is finally a way out of the morass, an escape route from all those wasted years. As the authors stated, adopting the CCC will “jump start progress and lead to much more rapid advancement in research and care for ME/CFS patients.” It gives hope that our disease will be treated as the terrible disease that it is and that progress will now come quickly. It gives hope that we will soon rise up from our beds!

This letter is both remarkable and historic for the ME/CFS community

But what does this letter mean in terms of the Institute of Medicine contract that Health and Human Services has just signed? Typically, like most contracts, government contracts have mechanisms built into them to allow the contract to be cancelled when the contract no longer makes sense.

Now that the ME/CFS experts have spoken, the path forward is clear. It does not make sense to waste money and time redefining the disease when the experts have now agreed upon the immediate adoption of the Canadian Consensus Criteria.

We need to send two strong messages to HHS:
  • First, HHS needs to immediately adopt the CCC as the sole definition for ME/CFS as the experts have called for.
  • Second, HHS needs to cancel the IOM contract, which is completely unnecessary, wasteful and a step backwards scientifically.
And, we need to forcefully engage our congressional leaders on this issue.

Further information along with the actions to take with congressional leaders will be provided by Mary tomorrow.

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Sources:
Sept 23, 2013 open letter from ME/CFS researchers and clinicians to Secretary Sebelius - here.
Sept 23, 2013 CFSAC announcement on the Institute of Medicine contract - here.

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However, the CAA has stopped short of rejecting the IOM contract and endorsing the CCC. They had a huge opportunity to stand beside the researchers and clinicians who said "No. We the experts already solved this problem. Spend the money on research instead of on unqualified people groping around in the dark.". And the organization with Research First as their slogan is supporting the IOM process. Just once I'd like to see a bold statement come from the CAA.

Looks like the CAA has not changed.
 
One strategy for silencing advocacy is to co-opt any willing advocates or organizations that are threatening to create waves. You get their cooperation, offer small things in return, and continue with your agenda. It works for environmental advocacy, and a book was written about it I think, from the PR company that does this for a living.


So it seems, Alex that HHS has read this book.
 
I guess one of the things we have to ask ourselves is how long it is likely to be until any research can lead to an improvement on the CCC. You might say, for example, that if the Rituximab trials work out, then that could blow all existing criteria out of the water; on the other hand if they don't work out - or only do for a minority - and the evidence for ME being an autoimmune disease is not forthcoming: to what degree is the CCC adequate. Is it enough of an improvement on what you have now in the US - the CDC definition - to bring things together and move us forward.

Personally, I am still at a loss to explain the need for a differing clinical and research criteria when we are where we are i.e. with a disease based solely on exclusion of other more demonstrable conditions and symptomology. NICE in the UK when reviewing all the criteria they did - and at the time (mid 2000's) found that the CCC lacked methodology when compared to other criteria. I don't know what process the IOM and DHSS want to apply to their review: but something needs to happen. Something needs to be agreed as a way forward.

I'm not going to delve into the clinical vs. research part of this but I do find the question of "what's good enough?" an interesting question. I would bet a disability check that nobody that signed the letter believes the CCC is perfect. I'm a believer in the 80% solution. This is coming from an anal perfectionist. It's taken me a long time to soften up to get to this point of view - in the macro. Because of unknowns, it's not really worth polishing something in an attempt for perfection because change will happen and evolution will happen naturally, usually faster than you can polish.

I think this is what happened with the IOM. The majority put their heads together and realized that talking a step backward to something like the Empiric definition (and who knows what the IOM will do to us) would take us from the 80% solution (CCC) to something twice that bad (40%) or worse! So they're attempting to drive a stake in the ground in an attempt to preserve the progress we've made and to allow those who spend all day every day working on the problem (i.e. not the IOM) to continue to refine the solution as we learn more.
 
I guess one of the things we have to ask ourselves is how long it is likely to be until any research can lead to an improvement on the CCC. You might say, for example, that if the Rituximab trials work out, then that could blow all existing criteria out of the water; on the other hand if they don't work out - or only do for a minority - and the evidence for ME being an autoimmune disease is not forthcoming: to what degree is the CCC adequate. Is it enough of an improvement on what you have now in the US - the CDC definition - to bring things together and move us forward.

Personally, I am still at a loss to explain the need for a differing clinical and research criteria when we are where we are i.e. with a disease based solely on exclusion of other more demonstrable conditions and symptomology. NICE in the UK when reviewing all the criteria they did - and at the time (mid 2000's) found that the CCC lacked methodology when compared to other criteria. I don't know what process the IOM and DHSS want to apply to their review: but something needs to happen. Something needs to be agreed as a way forward.

I agree it's a good point that things could change soon and that may be a good reason to postpone a new definition (particularly two/three new definitions, as CDC is also doing one), but I don't think that's a good reason to continue to use Oxford, Empirical, or even Fukuda in the meantime. We could use an existing, more specific, definition now, and make a new definition later when we have more info.

I don't trust NICE's conclusion. I think the main differences are 1) whether government was involved. and of course 2) how much say the actual experts had, thus, comparative specificity.
 
One strategy for silencing advocacy is to co-opt any willing advocates or organizations that are threatening to create waves. You get their cooperation, offer small things in return, and continue with your agenda. It works for environmental advocacy, and a book was written about it I think, from the PR company that does this for a living.

This is a variation on the theme but it's evolved. This organization hasn't represented a real threat to the establishment in a long, long time. They are the establishment. They sold their soul a long time ago. They put on the face of a research org and suck in donations. There's a book in this one too. Hillary wrote part of it.

They churn out doublespeak faster than the US government which in a way is impressive. Before the letter opposing the IOM contract was announced the CAA announced it would not oppose the IOM, which is to say it supports it.

In their words:

The CFIDS Association believes that any review of current clinical diagnostic criteria should include requirements to validate and operationalize the Canadian criteria. Further, the clinical case definition must be useful in primary care as well as tertiary care settings. Diagnostic criteria that define core symptoms will increase the diagnostic certainty, increase the likelihood of identification and validation of biomarkers and can provide the guidance needed to develop safe and effective treatments for ME/CFS – which is central to our mission to make ME/CFS understood, diagnosable and treatable.

For any of you who have listened to Dr. Unger (while sticking pencils in your eyes) these words probably sound amazingly familiar. In other words, let's study the problem until all patients alive today are freaking dead.

Rewind a couple of years. Presto chango, one Jedi Mind Trick later and the CAA is just doing research. They haven't had to answer any hard questions from advocates in years. What an amazing slight of hand. Now they're in the business of telling DHHS how they think a criteria should be selected/developed.

Well, GAME ON, CAA. I'm with the signatories of the letter opposing the IOM.
 
There's so many names on the list, it's hard to remember who's signed, and who hasn't.

Here's the full list of signatories:

Dharam V. Ablashi
Lucinda Bateman
David S. Bell
Gordon Broderick
Paul R. Cheney
John K.S. Chia
Kenny L. De Meirleir
Derek Enlander
Mary Ann Fletcher
Ronald Glaser
Maureen Hanson
Leonard A. Jason
Nancy Klimas
Gudrun Lange
A. Martin Lerner
Susan Levine
Alan R. Light
Kathleen C. Light
Peter G. Medveczky
Judy A. Mikovits
Jose G. Montoya
James M. Oleske
Martin L. Pall
Daniel Peterson
Richard Podell
Irma Rey
Christopher R. Snell
Connie Sol
Staci Stevens
Rosemary A. Underhill
Marshall V. Williams

International Signatories

Birgitta Evengard
Sonya Marshall-Gradisnik
Charles Shepherd
Rosamund Vallings
 
The problem with all the UK efforts (such as NICE and Oxford) is they review the range of existing criteria and form a new one. This process assumes that the existing criteria are targeting the correct patient group. But they never question the fatigue-centric model. They take for granted that it's correct and proceed from there.

An illness should be defined by the manifestations of the illness within the patient population, not by the name someone came up with years ago.
 
Mary, thank you for this important review. Here's a perspective on the perils of democracy in medicine, and possible context for the CAA's baffling stance on the IOM contract.

"THE BEST ARGUMENT AGAINST DEMOCRACY IS A FIVE-MINUTE CONVERSATION WITH THE AVERAGE VOTER."

This quote by Winston Churchill precisely sums up the problem with using a “consensus-building methodology” amongst a group of ME/CFS virgins... scientists who have little credible experience in M.E. clinical practice nor research, such as the IOM group. The voting process will merely stoop to the masses – not necessarily to the right answer.

Touting “consensus-building” for the development of ME/CFS criteria as a good thing is tantamount to saying, “We will let the majority rule”. One need only look at the ten-fold epidemiological expansion by the Fukuda criteria, to understand that if a vote were taken amongst scientists working on the hodgepodge definition known as “CFS”, the M.E. voices would be obliterated by the din of the Average Joe: the fatigued, sedentary, out-of-shape CFS patients, many of whom who may indeed do swimmingly well with CBT and GET. No doubt the NICE folks are slathering over the opportunity to talk about "CFS" epidemiology.

But there are already hundreds of millions of dollars spent on depressed, out-of-shape patients; this is an exercise in redundance. The yawning chasm in funding and care is for neuro-immune patients with the constellation of post-exertional pathology known as ME/CFS.

In other words, when you take the wrapping off those shiny words: “Consensus-building Methodology”, the only credibility that remains is that afforded by the voters you have put together. In the case of the IOM, that amounts to, “Not Much”. This process would be akin to taking a poll of current practice in ME/CFS "treatment". The majority of practitioners (and I’m not talking about ME/CFS specialists such as Drs Peterson, Kogelnik, Fluge, Mella, & Montoya) are out to lunch, uninformed, stale, and often outright dangerous to their patients, by either ignoring the patient (or telling them to ignore their pathology), or by routinely prescribing exercise without qualification (i.e. without following Anaerobic Threshold limits), for a patient population for which this prescription is outright dangerous. As Winston Churchill would suggest, put a bunch of uneducated, inexperienced voters together in a room, and you deserve the cr@p you paid for.

So YES, let’s save the money from this exercise in futility: the IOM contract. And why not direct these funds to people who know what they’re doing – the signatories on the letter to Kathleen Sibelius.

A WORD ON MARKET SHARE
One final thought: when considering which parties did not sign the letter, I agree that many credible voices may have been merely swamped by their day-to-day work on ME/CFS; after all, the turnaround on the writing of this letter was nothing short of miraculously fast. However some voices – particularly those who have positioned themselves as “the voice of the ME/CFS community” may have some ‘splaining to do. Consider that funding for research organizations is heavily influenced by the number of people afflicted with a given disease. If you mash together “CFS” – fatigue from just about any cause – with ME/CFS, you end up with somewhere near a 10-fold expansion of your “influence” – and potentially a risk of a ten-fold reduction in budgets, should the focus shift from idiopathic fatigue-of-any-origin to the post-exertional, neuro-immune entities that fall under ME/CFS.

Just sayin’: if you’re wanting to understand why the CAA supports the IOM contract, one avenue of enlightenment is to Follow the Money.
 
Parvofighter

You make great points. We know this letter happened quickly since the IOM wasnt announced til August 27 and that these are all very busy people. And the situation with HHS' plans with IOM kept changing so quickly which must have complicated pulling this together. There can be a number of reasons why any one person didn't sign. Short of having a discussion with each individual, we cant possible know

But to me the key thing to focus on is how many did sign. That is nothing short of remarkable and I am so appreciate that they were willing to take this collective stand.

Regarding CAA's position, I cant speak for them. But their announcement stated that "any review of current clinical diagnostic criteria should include requirements to validate and operationalize the Canadian criteria". CAA would not have taken this position if they were truly focused on fatigue from any cause.
 
I have a quandary here but I don't want it to be taken as a statement against what they experts did. I'm actually thrilled with what they did. They not only spoke out against this IOM process, but also conveyed that they are going to continue using the CCC and possible advancing it via the ICC.

But here's my quandary. If we (as activists) boycott the IOM, we are leaving the process completely in the hands of a) people who know nothing about ME/CFS and b) organizations like the CAA who always seem to be not on our side. And when it is all over, the government can say they gave patients the opportunity to speak and included a major ME/CFS organization. OTOH, if we do involve ourselves, at least we have a chance to give input. Problem is, though, have you ever seen a single instance where this type of project actually used patient input. Usually it is nothing more than a pat on the head, and then they do what they want anyway.
 
I would like to at least point out one important point about where all this may be coming from - the need for an "objective" measure. In other words, the CCC can basically be imitated by anyone wanting to claim they have CFS. As a CFS sufferer, believe me, I understand the complexity of the issue, having recently been burned by my own PCP. But we should at least keep in mind that institutions may have a fundamentally sound reason to search for such criteria. Not that I am taking sides here, just trying to keep us all from looking at HHS as the enemy. That is not productive, even if we think they are wrong.
 
I have a quandary here but I don't want it to be taken as a statement against what they experts did. I'm actually thrilled with what they did. They not only spoke out against this IOM process, but also conveyed that they are going to continue using the CCC and possible advancing it via the ICC.

But here's my quandary. If we (as activists) boycott the IOM, we are leaving the process completely in the hands of a) people who know nothing about ME/CFS and b) organizations like the CAA who always seem to be not on our side. And when it is all over, the government can say they gave patients the opportunity to speak and included a major ME/CFS organization. OTOH, if we do involve ourselves, at least we have a chance to give input. Problem is, though, have you ever seen a single instance where this type of project actually used patient input. Usually it is nothing more than a pat on the head, and then they do what they want anyway.

It is a difficult issue to grapple with, isn't it.

For example, should we now continue our advocacy efforts by recommending that our favoured experts are nominated to the committee?

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.
https://dl.dropboxusercontent.com/u/89158245/CFSAC Sept 23 2013 IOM announcement.pdf
 
I would like to at least point out one important point about where all this may be coming from - the need for an "objective" measure.

You are right, Rich, in stating that we need an "objective" measure for this disease. That is the aim of all the research that is out there - finding the elusive objective measure.

Some might say that this has somewhat been achieves by the two day exercise testing to prove post exertional maliase (PEM). We certainly need more though.

But, this is a catch 22

In order to achieve quality in research we need an effective diagnostic criteria to better select a "tight" patient population. If we don't obtain this better selection of patients in studies, the outcomes will reflect what we have seen as the psych slant on this. We will get more recommendation for GET/CBT, anti-depressants and the like. This in turn will guaranty to produce conflicting and explainable results to impede the validation of objective markers.

This impediment is the real danger of letting an inexperienced IOM produce diagnostic criteria

Dr. Kenneth Shine, former IOM president who is the was heard stating he could not recall when the IOM was last charged with defining a disease.

In other words, the CCC can basically be imitated by anyone wanting to claim they have CFS.

It is the outdated CDC, Fuduka criteria which mostly overlaps with depression. The CCC has PEM as a hallmark symptom. Most patients who suffer from idiopatic fatigue do not suffer from PEM.

Is the CCC perfect? I don't think anyone is saying that. It is certainly a great improvement on Oxford or Fuduka. The clinicians and researchers in their letter agreed to take the CCC as a starting point and then work on improving on it.

As a CFS sufferer, believe me, I understand the complexity of the issue, having recently been burned by my own PCP. But we should at least keep in mind that institutions may have a fundamentally sound reason to search for such criteria.
(my bold)

This is my personal greatest fear - that patients will just blindly trust that "institutions" will do the right thing. If we don't learn from history, where are we? It has been almost 30 years, since the outbreak in Lake Tahoe. Where are we as patients with the care of HHS, NIH and CDC? You state that you have been burned by your own PCP. I have been burned by mine ten years ago! This caused me to become more severely affected and to lose my job. I am totally disabled now. Whose fault is this? I can't really blame my GP. He has been taught by the CDC toolkit as to how best DAMAGE me. The NIH has less funding for this severe illness of one million Americans than most diseases. NIH has no funding for important studies like the Ian Lipkin study to find pathogens which could lead to biomarkers.

Not that I am taking sides here, just trying to keep us all from looking at HHS as the enemy. That is not productive, even if we think they are wrong.

In my opinion, if we just let HHS to their own devices without any actions from patients, advocates, clinicians and experts, we would all be either drugged up on anti-depressants or in nursing homes due to the damage from exercise.