(Mary has given permission for this to be shared widely and reposted)
Mary Dimmock asked IOM and HHS some questions about the IOM study. Find out if she got answers…
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.
Speak Up About ME 
Published October 7, 2012 Uncategorized Leave a CommentTags: advocacy, budget crisis, CDC, CFSAC, chronic fatigue syndrome, definition, DHHS, early onset ME/CFS, funds, government, health, IACFS/ME Primer, ME/CFS, medicine, NIH, public comment, research, science, SEP panel, state budgets, treatment, Washington
The public comment presented at the CFSAC meeting October 3 and 4, 2012 was strong, and some excellent points were made (some of them over and over again). Federal funding for ME/CFS research is pitifully small and the public comment by Ms. Janelle Wiley provided some interesting comparisons.
Ms. Wiley (who provided her comment by phone) has kindly given permission to share her public comment here:
“Hi, I cannot travel to speak to you in person but it’s Good to be with you by phone; thanks for your attention to ME/CFS. One thing that strikes me when listening to CFSAC meetings is that there is never any encouragement for any funding.
There is no reason under the sun why ME/CFS is not being funded like any other disease. Yes, I get that there is a budget crisis and we need to spend less on the national budget. But the amount being spent on our disease or disease spectrum–6 million dollars in a good year–is easily available to many state budgets. North Carolina spends 10 million on aquariums. The city of Glendale, Arizona, spent 23 million in outside counsel over 5 years, which is 4 million per year (we get that amount some years). California spend almost 45 million on new vehicles and almost 30 million on new furniture. New York is spending 50 million dollars on ads promoting its business policy. These aren’t necessarily bad projects; point is that our budget or even 5 times more is well within the reach of a much smaller body right now in this current economy.
It is shameful that ME/CFS is basically not being funded.
Whatever model it is we are using to fund research, it should be applied to ME/CFS the same as to Lupus and cancer and Alzheimer’s, taking into consideration the burden and incidence of the disease.
I do not know what the hangup is, but it is not the sad state of the national budget. That’s just an excuse. Whatever the problem really is, please fix it. This is a very serious disease which isn’t being handled seriously at all. I don’t think the problem is in this room, but please talk to your uplines. Thanks.
In using funds to do studies, there are two main things that need to be addressed. One is the SEP panel. Typically it is staffed with mostly people who are mostly interested in psychogenic theories. These theories are not scientific—e.g. cannot be proven and do not consider alternate hypotheses or accept disproof—and have not yielded any useful ideas: they did not for Parkinson’s disease or multiple sclerosis, and they are not for fibromyalgia, TMJ, or ME/CFS. It is past time to consciously change the bias from the psychogenic to the biomedical.
The second is the definition. There has been a lot of talk about lumping and splitting. Both are appropriate methods of approaching a problem—to a point. But there is a point at which lumping becomes absurd. When you are no longer lumping “people who are similar to ME/CFS” together and you’re gathering “people whose doctors or researchers have not (or have not bothered to) figure out what’s actually wrong with them”, you’ve gotten to the absurd point.
There are multiple inclusion criteria for CFS or ME/CFS being used. It’s well known that the Oxford inclusion contains large numbers of people who can be diagnosed with other conditions. A Newcastle study demonstrates this. David Tuller wrote about it in the New York Times. We wrote about it in ME Analysis. It’s been mentioned here at CFSAC a lot. The Oxford inclusion identifies people who have longlasting fatigue of definite onset without requiring other symptoms. CDC says this is “idiopathic chronic fatigue” and not CFS. Yet the CDC, like most everyone else, makes heavy use of Oxford studies to decide what to do with ME and CFS patients. This is not science. It’s kind of, quackish. Many articles in the literature call attention to problems with this.
The “Empiric” surveys which are used by CDC to attempt to operationalize the Fukuda criteria select—almost entirely—people who do not have ME/CFS. This approach to inclusion has been rejected by CFSAC, by the international symposium at Bond University, and by patient advocates around the world. And in the literature. The problem with this approach is that it allows feeling depressed or sad to substitute for debility and fatigue. Those are not actually the same thing. It’s no wonder CDC’s webpage claims it’s difficult to distinguish between depression and CFS! They looked for depression under the title of CFS, and found depression, which they label CFS. Funny how that works.
Also, education. CDC is very proud of themselves that they have educated a lot of people. What they may not realize is that, partly because of the uncorrected problems with inclusion criteria, CDC’s information is very wrong in many particulars. Despite the urgent need for physicians to know about this condition, I, like many others, am actually appalled that multiple health care providers have seen CDC’s education. Misinformation is actually worse than no information. The IACFS/ME’s Primer is a useful document which exists now.
So in summary, what we need is funding—and this is attainable—and we need to use it wisely. Quit relying on the psychogenic model, and instead rely on a model that produces solutions: biomedicine.
Thank you”
References:
Thank you to everyone who participated (in any way shape or form) in the October 2012 CFSAC meeting!
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