≡ Menu

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

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…

Mary Dimmock

Mary Dimmock

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.

Shop via one of these links and Phoenix Rising gets up to 8% of your spend at no cost to you!
Phoenix Rising’s US Amazon Store Phoenix Rising’s UK Amazon Store
Phoenix Rising's store with all our big-name affiliates

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.

{ 84 comments… add one }

  • beaker September 24, 2013, 2:30 am

    yay ! I await Mary's instructions.
    Let's hope they are heard. Let's make sure they are heard.
    ed:
    Make that a "we" instead of "they" !

  • Roy S September 24, 2013, 2:35 am

    Thank you Mary.

    I've been thinking of the following for quite a while.

    An advisory committee for AIDS at least discussed resigning en masse to protest poor response of the US government. Sorry for the dim memory but I think it was 1991 during a relatively short relapse for me while living on Capitol Hill. I haven't been able to find information on it online. It seems like the name of the woman chairing the committee was something like Dr. Osborn.

    Perhaps the CFSAC should consider doing that now after three decades of government screwups and 20+ years of being ignored.

    Back then on Capitol Hill I endeavored to be the model of diplomacy in representing the patient community. After seeing what has transpired since then I think we need less diplomacy sometimes and more healthy activists all the time.

  • Nielk September 24, 2013, 6:44 am

    Thank you Mary for this very important article!
    A special shout out to Russ for working so hard to rush this through:)

    This is huge news.

    Since the beginning of this proposed action on August 29th, I have been thinking what are our clinicians thinking about this? Where do they stand? Do they want this action to go through?

    The whole world can clearly see their answer. I am so impressed that they have taken time out of their busy lives and worked on this in the background in unity and presented it to the secretary of health.

    I have been feeling very dejected about the fact that HHS seemed to follow their agenda no matter what. I know that many of you were excited about HHS' e-mail of yesterday where they state that they have heard us and we will have a voice in the process. Are we going to have the same voice as we have had at CFSAC for the past ten years? We have repeatedly begged them to adopt and recognize the CCC and work from there for the past ten years and what was their answer? "It is too complicated for physicians to follow". I think that the IOM which by the way never in it's experience were charged with creating diagnostic criteria for disease (except currently for GWI), will just give HHS a larger platform to work their agenda.

    I was telling a friend yesterday that we really have no leverage when it comes to impressing HHS. All we can do is send e-mails to them and/or congress. Why should they listen? Our leverage has just come in the form of this letter from our physicians and researchers! No one else can know this disease better that the signed 35.

  • Denise September 24, 2013, 7:16 am

    Thanks to Mary for the review, thanks to PR for rushing this news to us, thanks to the signers!
    Looking forward to the next steps for us to take!

  • snowathlete September 24, 2013, 8:19 am

    Very pleased to see this, I think it is the correct approach, so well done to them and others behind the scenes who helped organize it. Hopefully we will continue to see more of the same going forward in other important matters.

  • LaurelW September 24, 2013, 8:38 am

    I was very pleased to see the list of signers–it includes every doctor and researcher I can think of that are in the field–quite a long list. If the government doesn't listen to this, they're fools and obstructionists.

  • concepcion September 24, 2013, 8:40 am

    Fantastic! It is such a relief to see the ME/CFS medical experts taking the lead and being so supportive of their patients.

  • Sasha September 24, 2013, 9:04 am

    I agree – it's great that our clinicians and researchers have got together to do this. I hope they might become more involved in advocacy as an expert group in future. We desperately need their help and they are uniquely positioned.

  • cruzgirl September 24, 2013, 9:09 am

    wow, great start to my day seeing this letter from all of our wonderful researchers and doctors. I can't wait to see what happens next. Sign me up with any follow through letters we may need to sign and send. Lets put money into research.

  • Nielk September 24, 2013, 9:26 am

    I just want to add here that we are in this mess of a crossroads here because HHS did not consult with anyone – not CFSAC, patient advocates nor our clinicians and researchers BEFORE embarking on this "secret" action.

  • medfeb September 24, 2013, 10:47 am
    Nielk

    Thank you Mary for this very important article!
    A special shout out to Russ for working so hard to rush this through:)

    This is huge news.

    Since the beginning of this proposed action on August 29th, I have been thinking what are our clinicians thinking about this? Where do they stand? Do they want this action to go through?

    The whole world can clearly see their answer. I am so impressed that they have taken time out of their busy lives and worked on this in the background in unity and presented it to the secretary of health.

    I have been feeling very dejected about the fact that HHS seemed to follow their agenda no matter what. I know that many of you were excited about HHS' e-mail of yesterday where they state that they have heard us and we will have a voice in the process. Are we going to have the same voice as we have had at CFSAC for the past ten years? We have repeatedly begged them to adopt and recognize the CCC and work from there for the past ten years and what was their answer? "It is too complicated for physicians to follow". I think that the IOM which by the way never in it's experience were charged with creating diagnostic criteria for disease (except currently for GWI), will just give HHS a larger platform to work their agenda.

    I was telling a friend yesterday that we really have no leverage when it comes to impressing HHS. All we can do is send e-mails to them and/or congress. Why should they listen? Our leverage has just come in the form of this letter from our physicians and researchers! No one else can know this disease better that the signed 35.

    Neilk said "Are we going to have the same voice as we have had at CFSAC for the past ten years? We have repeatedly begged them to adopt and recognize the CCC and work from there for the past ten years and what was their answer? "It is too complicated for physicians to follow". I think that the IOM which by the way never in it’s experience were charged with creating diagnostic criteria for disease (except currently for GWI), will just give HHS a larger platform to work their agenda."

    My thoughts exactly. My concerns have not changed and now that the experts have spoken, why would HHS pursue this initiative.

  • readyforlife September 24, 2013, 11:09 am

    So am I reading this correctly?? The IOM contract is still going through but they have to "use a process with stakeholder input, including practicing clinicians and patients" And it's going to take them 18 months to do this? I was hoping that in the next year we would have some huge break through with a medication to help us. And it's going to take them 18 months just to come up with a Diagnostic Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome?

    The bright side I guess is that they will collaborate with CFS/ME patients, researchers and clinicians. And have faith they will not do something behind our backs….again.

    As I read the letter from HHS announcing the IOM study a few things pissed me off. I didn't like how pleased they are and how they bring up that the study grew out of the 2012 CFSAC recommendation.

    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.
    I'm so glad they are pleased with themselves after what they put us through and tried to sneak behind our backs.

    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.

    This is their way of saying you asked for it. Yes but we didn't ask for them to lie and go behind our backs and choose a definition with out our community being involved.

    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.

    Now they state how proud they are. Pleased and Proud. Well i'm SICK AND TIRED!!!! I want to trust in them but it's going to be really hard to do.

    To all the hardworking cfs/me advocates/patients within our community that push for change and make sure that nothing slips past us…..THANK YOU.

    Readyforlife

  • Sasha September 24, 2013, 12:01 pm

    Blog post from Jennie Spotila on the latest developments:

    http://www.occupycfs.com/2013/09/24/the-experts/

  • Chris September 24, 2013, 12:01 pm

    Great news–and all our thanks to the great doctor/researchers who have been doing their best for us for years, and now come up with a strong and united voice that will–we hope–be impossible to ignore. This is real collaboration! Chris

  • Sasha September 24, 2013, 1:56 pm

    Article on this by Cort on Health Rising:

    http://www.cortjohnson.org/blog/201…and-blasts-federal-efforts-create-definition/

  • Otis September 24, 2013, 2:34 pm
    aimossy

    there is another letter up on research1st.
    well done you PR ninjas!:ninja:

    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.

  • Roy S September 24, 2013, 2:49 pm

    There are some blogs on the subject listed here although not all ME bloggers are on this list.
    http://mecfsblogroll.blogspot.com/

  • Firestormm September 24, 2013, 3:23 pm

    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.

  • Ecoclimber September 24, 2013, 3:24 pm

    Why this is important to notify your representative

    The Institue of Medicine, IOM, redefined another illness GWI or GWS which is similar to ME/CFS in 2013. The veterans have a strong lobby in Congress

    Even though the IOM stated that these men and women were exposed to biological and chemical toxins, depleted uranium, particulate matter and infectious agents and the IOM acknowledge them as contributors, and it found it found most compelling the scientific evidence that the prime culprits were neurotoxins — in overused insecticides, experimental anti-nerve gas pre-treatment pills, and sarin plumes from the Air Force’s bombing of an Iraqi weapons plant!

    The committee evaluated all treatments for which there was evidence, including prescription medicines and alternative therapies. On the basis of the voluminous evidence it reviewed, the IOM committee cannot recommend one single therapy to manage the health of veterans with CMI and, further, rejects a one-size-fitsall treatment approach. Instead, the committee endorses individualized care management plans.

    The committee notes that the best available evidence from studies of treatments for CMI and related health conditions demonstrates that veterans who have CMI may benefit from such medications as selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors, and from cognitive behavioral therapy, which has been shown to reduce symptoms.

    Other interventions and approaches hold promise for treating CMI but lack robust scientific evidence of their effectiveness. For this reason, the VA should fund and conduct studies of interventions, such as biofeedback, acupuncture, St. John’s wort, aerobic exercise, motivational interviewing, and multimodal therapies.

    So you now know what the outcome will be for ME/CFS if you don't contact your respresentative! Need I say more?

    Eco

  • Andrew September 24, 2013, 3:39 pm
    Otis

    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.

  • alex3619 September 24, 2013, 4:37 pm

    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.

  • Nielk September 24, 2013, 4:48 pm
    alex3619

    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.

  • shannah September 24, 2013, 4:56 pm

    Dr. Kogelnik's endorsement is conspicuously missing – also a couple of others. Anyone know why?

  • Otis September 24, 2013, 5:00 pm
    Firestormm

    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.

  • Otis September 24, 2013, 5:04 pm
    shannah

    Dr. Kogelnik's endorsement is conspicuously missing – also a couple of others. Anyone know why?

    This thing played out pretty fast. I'm pretty surprised and impressed at how many they got on board so quickly.

  • WillowJ September 24, 2013, 5:14 pm
    shannah

    Dr. Kogelnik's endorsement is conspicuously missing – also a couple of others. Anyone know why?

    At this point, no one seems to know for sure but it could be simply lack of time. Montoya is also missing, as are some others.

    ETA: I have now found Dr. Montoya's name on the list!

  • WillowJ September 24, 2013, 5:19 pm
    Firestormm

    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.

  • Ecoclimber September 24, 2013, 5:36 pm

    Montoya's name is on the list

  • Otis September 24, 2013, 6:14 pm
    alex3619

    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.

  • Bob September 24, 2013, 6:56 pm

    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

  • Andrew September 24, 2013, 7:52 pm

    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.

  • WillowJ September 24, 2013, 9:11 pm
    Ecoclimber

    Montoya's name is on the list

    Thanks. I just noticed this and came back to correct my post. Found your correction, too (which was a lot more timely!) And Bob's.

  • parvofighter September 24, 2013, 10:00 pm

    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.

  • medfeb September 25, 2013, 3:59 am

    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.

  • Nielk September 25, 2013, 7:46 am

    There is some major problem with this fiscal picture:

    -Ian Lipkin announcement that NIH has no funding for his pathogen study.

    -HHS announces they have a million dollars just laying around to play public charade.

  • Andrew September 25, 2013, 8:50 am

    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.

  • Rich D September 25, 2013, 9:58 am

    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.

  • Bob September 25, 2013, 10:37 am
    Andrew

    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

  • Nielk September 25, 2013, 11:08 am
    Rich D

    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.

  • Iquitos September 25, 2013, 2:07 pm
    Otis
    aimossy

    there is another letter up on research1st.
    well done you PR ninjas!:ninja:

    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.

    As usual. The CAA always puts it's finger to the wind to see how to respond to anything and then tries to run to the head of the parade once they figure it out.

    "Just once I’d like to see a bold statement come from the CAA."

    Not going to happen.

  • Otis September 25, 2013, 2:34 pm
    medfeb

    Parvofighter

    Regarding CAA's position, I cant speak for them. But their announcement stated that "any review of current clinical diagnostic criteria should include requirements validate and operationalize the Canadian criteria". CAA would not have taken this position if they were truly focused on fatigue from any cause.

    I agree with Parvo on this one but for me it's a secondary issue relative to the moves of recent days. Although if they eventually have a say in the definition we'll definitely see that issue arise.

    They've used words like this in an attempt to not alienate the signatories of the letter while simultaneously publicly supporting the IOM contact. If their nose were any further up the Secretary's butt they could see out her belly button. The CAA is very much a political entity. Watch the actions. Ignore the words. When the cards start flying at the IOM game, I expect the CAA to have a seat at the table with a nice stack of chips.

    Let's hope our docs and researchers get heard and are able to scuttle the IOM contact or it could get ugly.

  • Nielk September 25, 2013, 4:06 pm

    See this new thread for an alert on advocacy action' http://forums.phoenixrising.me/inde…opt-the-ccc-cancel-the-iom.25473/#post-390297

  • Hope123 September 25, 2013, 4:34 pm

    Quick comments:

    1) The initial letter was NOT sent to all clinicians and researchers but is being spread further now so there may be more signatories in the future. If your favorite clinician doesn't sign, you should ask them why.

    2) There's nothing wrong with both opposing the IOM contract and then bombarding them with comments if they decide to go with it anyway. I see no contradiction in asking for an cancellation now but working within the confines of what we have once we get there. We've been doing that all along anyway.

  • Otis September 25, 2013, 5:18 pm
    Hope123

    Quick comments:

    1) The initial letter was NOT sent to all clinicians and researchers but is being spread further now so there may be more signatories in the future. If your favorite clinician doesn't sign, you should ask them why.

    2) There's nothing wrong with both opposing the IOM contract and then bombarding them with comments if they decide to go with it anyway. I see no contradiction in asking for an cancellation now but working within the confines of what we have once we get there. We've been doing that all along anyway.

    Good points.

    The second one is interesting. I too think the stand that the initial 35 took made a double statement. "You can't ignore us one way or the other." But I think that makes their push to cancel the contract all the stronger.

    I'm not sure how much flexibility will be shown be any one of the group given how strongly worded the letter was. I think they'll insist on using the CCC as the starting point and very strong evidence for ANY deviation. I don't see the signatories going along with some clean slate fishing expedition trying to cast a harpoon into every idiopathic chronic fatigue whale around**. So I'm not sure how much patience with the process will be shown by the signatories.

    I have wondered, if some clinicians/researchers didn't sign in order to have a strategic reserve of like-minded people (without or without such discussions with the group of signatories) in the event the IOM contract goes forward. I tend to doubt it. I think this was an all hands on deck exercise given the time allowed, but nonetheless this wrinkle intrigues me.

    * * No whales have been harmed in the writing of this post. If I could go outside I'd hug a tree, I would. Of is that wood? :confused:

  • Rich D September 26, 2013, 10:10 am
    Nielk
    Rich D

    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.

    I didn't say we shouldn't take any actions, I'm just pointing out that as frustrated as we all may be, it doesn't serve us to make the HHS into the enemy. I don't think they are out to get us, they are just not well informed. Let's not impugn their motives.

  • Otis September 26, 2013, 1:02 pm
    Rich D

    I didn't say we shouldn't take any actions, I'm just pointing out that as frustrated as we all may be, it doesn't serve us to make the HHS into the enemy. I don't think they are out to get us, they are just not well informed. Let's not impugn their motives.

    This is just a discussion in a little corner of the 'net and you're going to chastise someone for questioning DHHS's motives? Funny, I saw references to actions in that post, not motives.

    What of the motives of CDC starting in the 80s? Are those out of bounds too?

    The fact of the matter is that DHHS is taking a very dangerous course of action, and ignorance is not an excuse. They have expertise at their disposal. The Secretary ignores it with great skill. She did the same with patient/advocate objections to the IOM prior to contract being awarded. When she started getting objections, she took it off the books and made it a private matter. So for the sake of examining motive, I can't possibly see this as above-board and benevolent even if I give it the absolute the most benefit of the doubt.

    And then there's the action itself. Letting a contract to an unqualified group who so completely sold down the river our own veterans – with so many parallels to our own struggles (AND they had served their country) – have this contract for ME is chilling.

    Personally I'm speaking out because I'm very concerned about the likely outcomes of an IOM-driven definition. Having said that, given DHHS's history with this illness and/or actions with this IOM contact alone, I don't blame anyone who distrusts DHHS' motives or feel they've made themselves the enemy based on their actions. All sample correspondence I've seen has been perfectly cordial. We can do that despite perhaps thinking differently.

    We don't have to be angry to take action but the action is really important. The link NeilK posted above is a great place to start. Please support the original 35 signatories who knew it was time to take a stand.

  • Christian Godbout September 27, 2013, 4:45 pm

    Who is the # 1 advocate (or any other person concerned) who will be the first to know of the HHS' reaction and decision regarding the experts' letter, and capable of informing us here? Who is in the absolute front row among us?

  • Otis September 27, 2013, 6:16 pm
    Christian Godbout

    Who is the # 1 advocate (or any other person concerned) who will be the first to know of the HHS' reaction and decision regarding the experts' letter, and capable of informing us here? Who is in the absolute front row among us?

    I'm not sure there's a singular answer answer to that question. If I want the latest news I go to twitter. #mecfs and #neurome are probably the best hashtags. If you want a head start with who you might want to follow I'm @OtisQuila and see who I follow. I tend for follow people who are posting news and research and not so much conversational types. There's nothing wrong with that but I like to use twitter as a quick info source.

  • Roy S September 28, 2013, 12:39 am

    This blog is troubling. Can anybody confirm this?

    http://thoughtsaboutme.com/2013/09/…g-signatories-to-withdraw-endorsement-of-ccc/

  • justinreilly September 28, 2013, 2:06 am
    Roy S

    This blog is troubling. Can anybody confirm this?

    http://thoughtsaboutme.com/2013/09/…g-signatories-to-withdraw-endorsement-of-ccc/

    Roy, I agree, but think "troubling" is the understatement of the century.

    I have contacted CAA on their blog and by email and asked for immediate confirmation, and if true, for an explanation. If and when I hear I will post here.