Nielk
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From OccupyCFS - http://www.occupycfs.com/2013/11/27/which-disease-is-hhs-studying/
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Created in 2008, Phoenix Rising is the largest and oldest forum dedicated to furthering the understanding of, and finding treatments for, complex chronic illnesses such as chronic fatigue syndrome (ME/CFS), fibromyalgia, long COVID, postural orthostatic tachycardia syndrome (POTS), mast cell activation syndrome (MCAS), and allied diseases.
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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.
But the Canadian Consensus Criteria define ME/CFS; the ICC define ME. Mary quotes and purports to agree with Dr. Carruthers. She writes that ME should not be considered a subgroup of CFS. Dr. Carruthers also writes about untangling "the web of confusion" by segregating ME, but he nevertheless describes ME as a subset of CFS: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.
Let's not add to "the chaos and the grievous harm to patients caused by years of sloppy definitions."While it has always been essential, it has now also become urgent to segregate the subset that we are calling ME more clearly, using the ME International Consensus Criteria, so that researchers can confirm/disconfirm their results using patients who have chronic fatigue of this clearly bio-pathological origin. Otherwise the all-inclusive umbrella of “CFS”, in ambiguating natural and psychosocial kinds of fatigue, will continue to dilute the results of any investigations and maintain the pervasive confusion resulting when biopathological kinds are mixed indiscriminately (emphasis added).
Dr. Carruthers holds that CFS and ME are complementary parts of a single disease concept, just as mycoplasma pneumonia, in an analogous way, is part of the pneumonia disease concept and migraine is part of the headache disease concept. But for clinical and research purposes, ME patients need to be segregated and treated separately.All three of these contributions agree on one point - that whatever it is we are talking about, it is a complex disease/illness - but on little if nothing else. There was special confusion on whether we were talking about CFS or ME, regarding them as mutually exclusive dualistic entities and not complementary parts of a single disease concept.
Yet I do favour striving for clarity, Chris, even in the midst of complexity. Definitions drive the research, so without clear definitions we won't get good research.Ember, I agree with you on this; I think it is a mistake to strive for too much clarity and definition in a situation that is not yet clear or even very well described.
The ICC identify not triggers, but rather “patients who have neuroimmune exhaustion with a pathological low threshold of fatigability and symptom flare in response to exertion.” Abnormalities underlying the criteria (PENE, neurological impairments, immune impairments and energy production/transport impairments) are presented in the ME definition and ME Primer: “There is simply too much evidence of pathophysiologic neurological and immune dysregulation, immune activation and an imbalance between inflammatory and anti-inflammatory mediators to be ignored [32–56].”Ember, I take your point that "a definition needs to be part intelligent hypothesis." But what hypothesis do you hold to as to the "presumed pathogenesis underlying our symptom clusters"?
Dr. Peterson urges clinicians to read the ICC because it emphasizes the presumed pathogenesis underlying the symptoms.When advances in scientific technology are applied to patients who meet the more specific case definition of the ICC for ME, the current urgent need for identifying and confirming specific biopathological mechanisms and biomarkers will be facilitated, and our improved understanding of the pathophysiology can then be directed towards enhancing treatment efficacy.
I suggest relying on the open letter to Secretary Sebelius:I may just be too exhausted right now to comprehend what is being discussed here, but I am really having a hard time understanding what people are talking about.
All 50 experts and 171 advocates have supported that statement.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 (Carruthers et al, Journal of Internal Medicine, 2011). 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. This step will facilitate our efforts to define the biomarkers, which will be used to further refine the case definition in the future.
Yes, what you have quoted is what I agreed to support when I signed the advocates letter. So I think I was just confused if a new argument was being made that the CCC wasn't a sufficient starting point to get the federal government "off the pot" and move this definition out of the dark ages.I suggest relying on the open letter to Secretary Sebelius:
All 50 experts and 171 advocates have supported that statement.