Which Disease Is HHS Studying?

I am very pleased to share space today with Mary Dimmock. She has written this guest post about which disease HHS has asked IOM to define. Her conclusion will probably increase any concerns you have about the IOM study. Mary has given us all permission to repost this article.


Mary Dimmock

HHS recently issued an FAQ about the IOM contract. As Jennie Spotila, Erica Verillo, Lois Ventura and Jeannette Burmeister pointed out, the FAQ falls far short of providing useful answers, is misleading and leaves critical questions unanswered.

Like the fundamental question: “What disease is HHS developing definitions for – ME or the diverse conditions that meet the overly broad “CFS” criteria?

I recently asked that question of both IOM’s Kate Meck and HHS’ Dr. Nancy Lee. From their answers, which I summarized below, the only possible conclusion is that the IOM study is intended to establish diagnostic criteria for the diverse conditions that meet the overly broad “CFS” criteria and that ME will be treated as a subgroup.

All of us, patients, advocates and experts alike, must reject this as completely unacceptable. We must call on HHS to acknowledge that ME is not part of the overly broad CFS. We must continue to call on HHS to adopt the Canadian Consensus Criteria.

We all know the problem. ME, the neurological disease characterized by post-exertional malaise, cognitive issues and immunological dysfunction has been buried inside of “CFS”, a diverse collection of medically unexplained fatiguing conditions. Numerous authors, especially Dr. Jason of DePaul, have reported extensively on the serious research and clinical problems caused by these overly broad CFS definitions, definitions that lump biologically unrelated conditions together. Dr. Bruce Carruthers summed it up simply, “There is a poignant need to untangle the web of confusion caused by mixing diverse and often overly inclusive patient populations in one heterogeneous, multi-rubric pot called ‘chronic fatigue syndrome.”

Having rejected the Canadian Consensus Criteria as unacceptable, HHS is conducting three separate initiatives to develop its own criteria. But what does HHS intend to do about the “web of confusion” that ha been created by “CFS”? What disease will these new criteria describe?

The ME/CFS IOM Statement of Work is ambiguous on this point as it uses the same jumbled, non-specific disease labels that have gotten us into this mess to begin with. The SOW states:

the Committee will consider the various existing definitions and recommend consensus clinical diagnostic criteria for this disorder [ME/CFS]. . .
The Committee will also distinguish between disease subgroups . . .
For the purposes of this document, ME/CFS shall be used to refer to Myalgic Encephalomyelitis (ME), Chronic Fatigue Syndrome (CFS), Chronic Fatigue and Immune Dysfunction Syndrome (CFIDS), Neuroendocrine Immune Disorder, and other terminologies in use for this illness.

I asked both Kate Meck at the IOM and Dr. Lee, the designated federal official for the CFS Advisory Committee (CFSAC) to clarify what “scope of disease” had been specified in the IOM contract. Has the IOM been contracted to develop clinical criteria specifically for ME? Or has IOM been contracted to develop clinical criteria for the range of unrelated fatiguing conditions that meet the “CFS” criteria? I asked Dr. Maier of NIH and Dr. Beth Collins-Sharp of AHRQ a similar question on the NIH Evidence Based Methodology Workshop process and am waiting on a promised response.

Here’s a summary of the responses I received from Dr. Lee of HHS and Kate Meck of the IOM:

Both Dr. Lee and Ms. Meck said that the scope of disease to be covered by the new clinical criteria has not been specifically defined at this point and that this will need to be defined as the process goes forward.

Dr. Lee indicated that the panel itself would need to resolve this issue and that possible outcomes could be ME as a subgroup of the broader CFS, ME as part of a spectrum that includes these other conditions, or ME as a separately defined disease. Ms. Meck indicated that HHS would be asked to clarify what scope of disease was intended at the first meeting. I raised the concern with Ms. Meck that the scope of disease directly affects panel selection and evidence base selection but she felt that the panel and process would be able to adjust as needed.

In a follow-up email, Dr. Lee confirmed the above statements but also reiterated an earlier point she had made that the IOM task list specifies that the “committee will also distinguish between disease subgroups”. She also said that in order for the target audience – defined as the primary care physicians – to effectively use the resultant guidance, “it is important to start a bit broad and then have criteria which distinguishes between subgroups.”

These answers are profoundly disturbing.

First, the statement that the scope of disease has not yet been defined is frankly hard to believe. This is a million dollar contract and panel selection is due to be announced soon. How can such a critical issue as the scope of disease to be covered by the new criteria be undecided at this point? If it really is undecided, who will decide and how? What criteria have been used to select the panel? And will that panel still be the appropriate one once a decision is reached on what disease or diseases the new criteria will cover?

But the statements about subgroups and spectrum of illnesses are much more disturbing.

Yes, ME is a complex disease that needs to be broken down into legitimate subgroups in order to better understand the disease and the treatment options. Perhaps those subgroups are based on whether onset is sudden or not, the level of severity of the disease or the nature of the immune profile and viral load. But let’s be realistic. What is the likelihood that the panel selected for the IOM study is going to be able to identify proper subgroups of ME itself when our experts are still working through that? Or when the evidence base lacks the ME specific studies – studies done with proper ME definitions – that would be needed to substantiate ME subgroups?

At the same time, we have an agency with a long-term commitment to studying medically unexplained chronic fatigue as the single clinical entity, “CFS”. We have an agency that has taken the position that Oxford, Fukuda and the Canadian criteria all describe the same set of patients for whom one set of clinical guidance is appropriate. We have an agency that questions the scientific evidence surrounding even post-exertional malaise and its measurement while simultaneously rejecting the Canadian Consensus Criteria because it does “not account for scientific evidence developed since 2003.” We have the CDC’s Dr. Unger, rhetorically asking at the May 2013 CFSAC “If a patient doesn’t have [PEM], wouldn’t you still manage them as a “CFS” patient?” And we have the IOM adopting the same overly broad view of CFS as HHS in recent IOM publications on Gulf War Illness.

Now we have Dr. Lee stating that the target audience of the new criteria is the primary care physicians and that they need criteria that start broader and then distinguish between subgroups. What about the patients who desperately need criteria that accurately reflect their disease?

What are we to conclude from all this? HHS has not committed to criteria specific to ME. HHS is not talking about the proper subgroups of ME that we all envision. HHS intends the IOM study to define criteria for the broader set of CFS conditions, with ME characterized as a subgroup. Or worse, ME becomes a subgroup of the even broader chronic multisymptom illness (CMI).

Either way, this will be a disaster that will degrade ME research and worsen the abysmal clinical care and stigma that ME patients receive today. This is the nightmare scenario that we all fear.

If HHS truly wants to reverse the chaos and the grievous harm to patients caused by years of sloppy definitions, it will first and foremost declare that ME, the disease described by the Canadian Consensus Criteria, is not the same disease as the overly broad “CFS” and should not be considered as either a subgroup of CFS or part of a spectrum of CFS diseases.

And if HHS cares not only about primary care physicians but also about the ME patients that they treat, it will acknowledge the harm done to patients by its clinical guidelines as reported at a recent Mount Sinai conference. CDC will immediately highlight PEM as a hallmark symptom of ME, will provide “black box warnings” about the adverse effects of exercise on ME patients and will point clinicians to the Canadian Consensus Criteria and the IACFS/ME primer.

Beyond that, HHS needs to immediately require that the Canadian Consensus Criteria be used in every study funded by NIH, even if it is used in parallel with Fukuda as an interim step.

Patients, advocates and experts alike must demand and accept no less, especially in the context of the IOM study and the NIH Evidence Based Methodology process.


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10 Responses to Which Disease Is HHS Studying?

  1. Sandra says:

    Since my public comment focused on the issues surrounding the IOM contract, I sent a copy of it to the IOM at mecfs@nas.edu. I wanted them to hear what I had to say as well. My testimony is right in line with your post, Mary. Thank you for all your hard work. Your post states well the crux of the problem.

  2. Sandra says:

    To clarify, I am referring to my public comment for the upcoming CFSAC meeting.

  3. Chris Heppner says:

    Hi; I have slightly mixed feelings about this whole issue. I fully recognize the dangers pointed out, and the past damage done, but there are some studies that seem to point to rather different subgroups even within well characterized ME patients. To make my perspective clearer, I am an 80 yr old male, with very late onset–at age 74. Julia Newton’s group has a little paper claiming that late onset patients show a different profile from most–chief symptoms being fatigue and OI; fits me (though I think she should have added PEM/PENE to simply fatigue).

    I am VP of the local support group, and am constantly surprised by how different the symptoms of many others are; same thing happens sometimes when I post on PR. I have to keep reminding myself that many have problems reading paragraphs–I don’t. I never have sore throats, flu, etc. Yet I fit comfortably within the ICC diagnostic criteria. There are others, like Baraniuk and the Lights, who have also found clearly different subgroups.
    So I am at this point seriously unsure about this whole issue

  4. Mary Dimmock says:

    Thank you for posting this for me, Jennie.

  5. Ess says:

    Thank you very much to Mary Dimmock for telling it like it is, sharing this most important tell-tale information with us on Jennie’s space. As we continue to read these blogs sharing information and ideas at a most pivotal time in the history of ME/CFS, and another blog post arises, it shows how much work is going on ‘behind the scenes’ to bring further awareness UPfront. Thank you all again!!

    This is a TRAIN WRECK of GIGANTIC proportions for sure–in an effort to ‘run-down’ very ill patients with ME/CFS–MILLIONS of us; children and young people included–put up in the FACE of SCIENCE getting CLOSER and CLOSER to the BIOLOGICAL ANSWERS of ME/CFS–geeee, this sure SCARES ‘them’ doesn’t it–such that, in lieu of intelligence, ‘they’ are defaulting to NONsense and STUPIDITY, POLITICS and ROAD BLOCKS.

    ‘They’ do NOT want the SCIENCE to prevail–how much more transparent can ‘they’ be–evidence, after evidence, after evidences presents ad nauseam.

    ‘THEY’ are FULLY well AWARE that ‘they’ are engaging in a less than mediocre RIDICULOUS IOM study/contract; that is ‘their’ intent. The IOM contract is GEARED to an / ‘their’ ultimate outcome of INaccuraties and LIES about ME/CFS and then declaring these as truths; that is ‘their’ intent. ‘They’ are fully aware of how DAMAGING this IOM contract is/will be to the ME/CFS people / patients / community; that is ‘their’ intent.

    ‘They’ do NOT care about the health of pw ME/CFS and offer mind-boggling STUPID answers to our articulate and intelligent questions–dismissing and disregarding SCIENCE and the knowledgeable voices and expertise of the ME/CFS EXPERTS AND RESEARCHERS and ADVOCATES.

    This all fits into the ‘plan’ / ‘their’ plan–keep putting up ROAD BLOCKS and use POLITICS to BURY the ongoing SCIENCE of ME/CFS–and BURY pw with ME/CFS–to SAVE the INSURANCE COs. money world-wide–and hide/cover-up any evidence of criminal activity. Keep BULLYING the ME/CFS community in an effort to make them / us go away.

    “Both Dr. Lee and Ms. Meck said that the scope of disease to be covered by the new clinical criteria has not been specifically defined at this point” — WOW–in a business corporation they would be FIRED for total INeptness!

    The fight is ON–CANCEL the IOM contract NOW!

    I wonder if MRS. OBAMA would be interested in this personally from the standpoint, particularly of SAVE THE CHILDREN . . . stricken with ME/CFS ?!!

  6. Mary Dimmock says:

    I hear your points about the number of intriguing ideas and studies that indicate potential subgroups. There’s some great work going on.

    My point was specifically in the context of the IOM panel. I don’t think we can realistically expect that a mixed group of experts and non-experts will be able to use the existing evidence base and discern appropriate subgroups of ME. Many of the studies are small and may not have been replicated yet. And to your point, there are different approaches to subsetting being tried out but I don’t think one has ‘won out’ over the others.

  7. Andrew Bokelman says:

    You can’t make a silk purse from a sow’s ear. You can’t make good criteria from weak research. You can’t have a project with integrity if the rules of that process prevent correction of profound and damaging mistakes. The IOM has said repeatedly that they are not responsible for any of the Gulf War report errors. They blame the panel. The panel blames it on the information they were given. The IOM review process prevents them from compelling the panel to do a better job. They can only suggest. And after that the final draft is kept secret until publication. This is not good science. This is not moral responsibility. This is a total crock, masquerading as a sophisticated research process.

  8. Ess says:

    It IS a total crock–and it is purposely done!

  9. Justin Reilly says:

    Mary, thank you for this great post! As has been said before, the definition should not be dumbed down for HHS’ intended audience of GPs to be able to diagnose without referring to a specialist.

    And as you state here, the definition should reflect the actual disease, not a goal of broadness which is somehow supposed to help GP’s, and which I even fail to see how this broadness would help GPs in any way. And to go in not being clear about what is being defined and then demand that the resultant entity be subsetted is ridiculous especially when, as you rightly say the science is NOT there.

    All this cr#p serves to do is to further HHS’ permanently held goal of dissapearing ME into a sea of fatigue.

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