By Lisa Petrison, Ph.D.
The preliminary version of the IOM report focusing on the disease that the government is currently calling “ME/CFS” was released yesterday (February 10).
I have read the report and am summarizing my most important reactions to it here.
What is the New Definition?
The proposed IOM definition is strikingly parsimonious, focusing on only five symptoms total.
My guess is that the reason for this is the hope that physicians will be more likely to make a proper diagnosis if a minimal amount of their time and effort is involved.
The symptoms chosen seem to have been in large part based on the work of Leonard Jason, a psychologist at De Paul University who has surveyed many patients about their symptoms and then analyzed the data.
This definition requires that patients have a “substantial reduction” in ability to engage in activities compared to pre-illness; post-exertional malaise; and unrefreshing sleep.
A fourth requirement is either cognitive problems or orthostatic intolerance.
Fatigue is mentioned in connection with the reduction in activity but not listed as a separate symptom.
For PEM, sleep and cognitive impairment, the definition reads: “Frequency and severity of symptoms should be assessed. The diagnosis of ME/CFS should be questioned if patients do not have these symptoms at least half the time with moderate, substantial or severe intensity.”
How Does This One Compare To Existing Definitions?
The existing U.S. government definition – usually referred to as the Fukuda or CDC criteria – requires fatigue and an additional four out of eight listed symptoms. Three of those eight symptoms (unrefreshing sleep, PEM and cognitive dysfunction) are mandatory in the new definition; the others (joint pain, muscle pain, headaches, tender lymph nodes and sore throat) are omitted.
Like the new definition, the Canadian Consensus Criteria requires a “substantial reduction” in activity level. The CCC also requires “post-exertional malaise or fatigue,” cognitive dysfunction and sleep dysfunction. In addition, it has a grab bag category that lists many symptoms, including OI. Unlike the new definition, which doesn’t bring up pain at all, CCC lists pain as a required symptom.
The International Consensus Criteria requires “post-exertional neuroimmune exhaustion” (similar to PEM) as well as multiple symptoms (including sleep disturbances, cognitive issues and OI) from each of three separate grab-bag categories. The definition specifically requires a 50% reduction in activity compared to pre-illness, rather than the “substantial” reduction mentioned in this new definition.
Of all these definitions, the new one looks most like the CCC (which probably should not be unexpected since experts and advocates campaigned so hard for the CCC). The main difference is that neither pain nor various other symptoms that are often but not always associated with this type of illness are even mentioned in this new definition.
Compared to the ICC, this new definition has more required symptoms and is less flexible in terms of symptom alternatives. It also is probably catching patients at a lower level of severity, since “substantial reduction in activity” seems like a milder standard than “50% reduction in activity.”
Another difference between the ICC and this new definition is that the ICC defines several severity levels – Mild (50% reduction in activity), Moderate (mostly housebound), Severe (mostly bedridden) and Very Severe (totally bedridden and needs help with basic functions).
Who’s Being Diagnosed?
One important question is whether people who actually have the established disease of ME are being diagnosed as having this new condition.
From what I have heard so far, people who meet the ICC or CCC definitions seem to be included. The general community response that I am getting seems to be, “Yes, I meet all those criteria – plus many, many more!”
One severely ill ME patient who qualified amply for an ICC definition stated that she did not qualify for this new definition because unrefreshing sleep was not a problem for her, though.
The unrefreshing sleep requirement is upon reflection a bit disturbing to me as well, because the very first symptom that often disappears when people pursue mold avoidance (often on their very first night of getting really clear of exposures) is the unrefreshing sleep issue. Even for people not intentionally following mold avoidance, I can imagine that someone who happened into a good environment might have their sleep symptoms resolve long before their health in general improved much.
So whether unrefreshing sleep should be a requirement is a big question mark in my mind.
The CCC also has sleep problems as a required symptom, but it includes reversed sleep patterns (which in my observation do not change as quickly when people get clear of mold exposures) as well as unrefreshing sleep as being sufficient to meet the criteria.
The new criteria exclude many of the odd grab-bag symptoms present in both the ICC and CCC as well as any kind of pain symptoms.
That would seem to suggest that more people would qualify for this new definition than for the ICC or CCC since the criteria are less stringent. The instructions try to make up for this by adding frequency and severity suggestions, but these are not mandatory.
Certainly this new definition seems less restrictive than the ICC, which has a 50% reduction in activity requirement as well as more needed symptoms.
In general, it would seem that increasing the frequency/severity requirement and throwing out all the odd symptoms that are specific to ME likely will make this new definition less likely than the CCC to catch some people at a stage when they are not yet really sick (but will be soon), since odd symptoms like environmental sensitivities or temperature intolerance often emerge early on.
Insofar as one assumes that there are no effective treatments for the disease, perhaps that doesn’t matter. On the other hand, if one believes that the illness may be effectively treated through early intervention (such as looking to see whether a toxic environment is a factor and addressing the problem if so), then not identifying people until they are really sick possibly may end up being a drawback of this new definition compared to the CCC.
In general, while it may be that the five symptoms being used explain most of the variance from the CCC and ICC in Dr. Jason’s model, I find it hard to believe based on my own observations of people with this disease that it explains all of the variance. All things being equal, I suspect that including more symptoms and allowing more flexibility results in more accurate diagnosis of people with this very complex condition.
On the other hand, the ease of use of this very streamlined definition undoubtedly makes it more likely that clinicians will actually put it to work, and so conceivably that could make decreased accuracy worthwhile.
For the most part, I tend to think that (if implemented) this new definition would be mostly accurate at properly diagnosing people who have ME and at excluding people who do not have ME (or do not have a precursor condition or a less severe version of the same thing).
So I do think it should count as an ME definition (including people with what I sometimes call “pre-M.E.” or “mini-M.E.”), even if some people or many people believe that there are better M.E. definitions out there.
What Impression Do the Criteria Give?
The main problem that I have with the criteria for this new definition is not so much that they are likely to miscategorize people, but rather that they are likely to give the wrong impression about the disease to clinicians.
My suspicion is that many clinicians merely memorize the criteria for a disease (or look them up online) and then don’t think about the disease much more. If they do that with these criteria though, they’re not going to be understanding the disease very well at all.
The five criteria listed in this new definition are symptoms that are not terribly useful in terms of making people understand how serious this disease can be or what it is like to have it. Insofar as a clinician believes that those symptoms are all there is to this disease, they are not going to be very likely to offer appropriate treatments and also may be perplexed at why people who they think are supposed to have just these five symptoms keep coming into their offices with long litanies of apparently unrelated complaints.
The idea of whittling down the many symptoms of M.E. to only a small fraction of the total is a little unexpected to me, considering that the trend in other very similar diseases seems to be going the other way.
For instance, Dr. Ritchie Shoemaker and colleagues now suggest that the most reliable factor that predicts whether people have toxic mold illness is how many symptoms from a pre-defined list people have. If you’ve only got a handful of symptoms, they say, you don’t have mold illness – but if you’ve got 20 or more, you almost certainly do.
Similarly, another IOM committee apparently was impressed enough by the wide array of symptoms in Gulf War Illness that they attempted to change the name to emphasize that component (“chronic multisymptom illness”).
Regardless, the idea that clinicians may remain unaware of the many odd symptoms in ME due to the parsimony of this new definition is of concern to me.
Conceivably this problem could be overcome by creating a list of symptoms that clinicians are likely to see in their ME patients and then promoting it heavily to them, but I do not see that list of symptoms nor that recommendation in this IOM document.
What Does It Say About Psych Theories?
One of my main advocacy goals is to put to rest the belief that the work done by Simon Wessely and his fellow psychiatrists in the UK has any relevance to this disease.
Therefore, one of my criteria for whether any government activity is appropriate is whether it leads us closer to that goal.
According to Jennie Spotila, IOM panel chair Ellen Clayton was adamant in the press conference introducing this report that the disease is not somatization.
That may be, but nonetheless, this report is by my reading wholly consistent with those psychiatrists’ views on this disease – thus explaining why Sir Simon himself expressed praise for it.
The Wessely School does not at this time openly espouse the idea that what it calls “chronic fatigue syndrome” is a condition of somatization or hysteria. Instead, these folks’ conception of the disease goes something like this:
“People originally got a bug or were under some kind of stress that negatively affected their physical body, and that kept them from exercising. And that was a legitimate physical problem. But then they got better (how could they stay physically sick forever?) and so then should have been able to exercise without any problem. Except – by that time they were deconditioned, plus they also were afraid of exercise because it was bad for them when they actually were physically sick. So because they were deconditioned, the exercise felt bad, and because they were fearful from before, they were reluctant to exercise, and the cycle perpetuated itself.”
As someone who has had this disease and who has read the biomedical literature on the topic of exercise in it, this sounds to me like one of the dumbest explanations for the exercise intolerance phenomenon that I could possibly imagine anybody proposing.
For instance, the literature on the two-day exercise tests shows that ME patients do not react to exercise in the same way that deconditioned patients do, and that there is something going on here that does not present itself in any other population group even when people are extremely debilitated and close to death.
But apparently most media reporters are much more easily swayed, considering how much play that “fear of exercise” paper got a couple of weeks ago. And many physicians believe this crap too, of course.
Unfortunately, I do not see anything in this IOM report that serves as any kind of rebuttal to this nonsense theory at all.
All that the report does with regard to this topic is to suggest a few times that it is inaccurate to say that this is psychogenic or psychiatric illness, as follows:
>Seeking and receiving a diagnosis can be a frustrating process for several reasons, including skepticism of health care providers about the serious nature of ME/CFS and the misconception that it is a psychogenic illness or even a figment of the patient’s imagination.
>ME/CFS often is seen as a diagnosis of exclusion, which also can lead to delays in diagnosis or to misdiagnosis of a psychological problem (Bayliss et al., 2014; Fossey et al., 2004; Jason and Richman, 2008).
>Some studies on awareness of ME/CFS have found high awareness among health care providers, but many providers believe it is a psychiatric/psychological illness or at least has a psychiatric/psychological component (Brimmer et al., 2010; Jason and Richman, 2008; Unger, 2011).
>Despite Dr. Ramsay’s work and a U.K. independent report recognizing that ME is not a psychological entity (CFS/ME Working Group, 2002), the health care community generally still doubts the existence or seriousness of this disease. This perception may partly explain the relatively limited research efforts to study ME in fields other than psychiatry and psychology.
What must be understood here is that the position of the UK psychiatrists is that this is NOT a psychiatric illness – that it is much more “complex” than that.
Therefore, the scattered statements in the report about how this disease is not “psychological” are not contradictory to their position at all.
Despite their “complexity,” those psychiatrists’ ideas remain very harmful to those with this disease – especially to patients in the UK but to those in the US as well.
Thus, insofar as people in positions of power are making an honest attempt to help those with this disease, fixing this problem should be one of the top items on the list.
One of the most disappointing things about the P2P draft report was that although it stated that the Oxford definition used by these psychiatrists was flawed and should not be used in the future, it did not suggest that papers that had used the Oxford definition in the past be discarded.
And one of the most disappointing things about the IOM preliminary report is that it does not make any attempt whatsoever to contradict the theories that these psychiatrists are espousing, even though there is now an abundant amount of literature that the panel members could use to criticize those theories.
Will It Hurt Or Help Severe Patients?
Another of my main advocacy goals is to increase attention to the severe ME patients, for the following reasons:
* Severe patients are likely to have the most obvious medical abnormalities, meaning that researching them will demonstrate what this disease is capable of doing and thus get it taken more seriously.
* Mild and moderate ME patients have the potential of becoming severely affected.
* Taking care of those who are suffering the most is the right thing to do.
For the most part, severely afflicted patients have been wholly excluded from research studies, due to the fact that it is easier and cheaper for researchers to work with mildly affected people.
This is just plain shortsighted, if our goal is to determine what is really going on in this disease.
Even when researchers have studied severe patients, they generally have not noted it in their publications.
For instance, considering that Jose Montoya was part of the research team, I would guess that the patients in the recently released Stanford brain study at minimum met the ICC or CCC. However, the paper only mentioned that the patients met Fukuda – thereby opening the door for somebody else to look at a group of Fukuda-only patients with a similar test and then suggest that the Stanford paper was wrong because they didn’t get the same result.
A disappointment with regard to both the P2P report and the IOM report is the total lack of discussion of the special issues involved in the critically important effort of researching or treating severely ill patients.
It is especially disappointing in the IOM report since a group of severe patients wrote a really excellent letter to the IOM committee members pleading with them to place emphasis on this topic.
In my opinion, many of the fractures that have occurred in the ME community have been a result of severely ill patients being ignored by everyone concerned – the government, these committees, other less sick patients, advocacy organizations, researchers, even most specialist doctors.
The idea that severe patients don’t matter is unfair and frustrating to them, leading to unhappiness and anger.
We need to put more attention on the severely ill patients, for the sake of everyone else with this disease as well as for their sake.
Efforts should include a panel funded by the government with the goal of evaluating what should be done; the development of a research definition much narrower than the one proposed by the IOM panel to focus on severely ill patients; government funding of research projects focusing on this population; and training of physicians on the topic of how to properly treat severely ill patients.
The addition of this recommendation into the IOM report would make it more likely that these activities actually would be implemented, I would think.
Is The Proposed Name A Good One?
Post-exertional malaise is a key symptom in ME and one that can be demonstrated through objective testing. I thus am glad that it is a requirement in this new suggested definition.
However, at this moment in time, naming the disease after this symptom (with the term “systemic exertion intolerance disease”) seems to me an enormous mistake.
One major problem is that although those who are familiar with this symptom understand how important it is, those physicians who are unfamiliar and currently skeptical about the disease are likely to interpret it as just another way to say that people with this illness get fatigued or are lazy or are afraid of exercise.
From a marketing point of view, if the goal is to dramatically change perceptions about the illness, choosing a name that expresses the same basic concept as the current name is not a good way to get anyone to put any thought into the topic or believe anything different about it.
The proposed name also is misleading in terms of the nature of the disease.
Yes, PEM is an important symptom, but it is not the only symptom or even the most important symptom for everyone. For instance, during my own long illness, I found the cognitive problems to be much more life-limiting to me than the PEM, and so I kind of resent the fact that the name being proposed here seems to suggest that the cognitive issues were unimportant. Undoubtedly other people feel the same way about other symptoms that they found particularly problematic.
Any name that forces someone to walk into the doctor’s office and start out by saying “I know that the name of my disease is X, but it’s actually so much more than that!” is, in my opinion, an epic fail.
The particular name being suggested is problematic as well.
For instance, the word “exertion,” to most people, means something substantial, like lifting something very heavy or running a marathon – not something trivial, like lifting a fork to your mouth or making your way across the hall to the bathroom.
Since avoiding substantial exertion is not very difficult, the likelihood that people who are not already knowledgeable will underestimate the challenges of having this disease based on this name seems to me extremely high.
In an age where tolerance in general is considered to be an important personal characteristic, having the word “intolerant” in the name of a disease regardless of the meaning seems to me a mistake.
So far, no one seems to have any idea how to pronounce the acronym “SEID,” and doctors will be unlikely to know either. That argues against the idea that they’re going to actually use it.
Some people seem to be thinking that SEID is not expected to be the permanent name of the disease – just something temporary until another name is found in a few years.
I really hate to say I am ever in agreement with Simon Wessely about anything at all, but it does indeed seem like it is a recipe for confusing the heck out of ordinary practitioners to change the name to one that nobody really likes with the plan of changing it again soon.
Insofar as the name of the disease is going to be changed, I think it should be to a name that we can feel really good about and want to use permanently.
The best that I’ve heard about this name is that it’s better than “chronic fatigue syndrome,” which is a really really low bar.
We can do better.
Unless and until a better name is found, when I mean “M.E.,” I’ll just say “M.E.”
The government has used this term officially, even if this consulting company committee has now recommended discarding it for something stupid. I therefore feel it’s a perfectly legitimate name to keep using in anybody’s eyes.
I feel confident that eventually brain inflammation will be found in this disease, and I think that myalgia (even though not mentioned in this new super-parsimonious definition) is an important enough symptom for the large majority of those with ME that it is not inappropriate to mention it.
It is not a name that is going to be interpreted by doctors as “just another name for fatigue,” and it is in Latin (which makes the actual symptoms it describes less important).
And most importantly, it is the established historic name of this disease, created long before the U.S. government got involved and then endorsed it.
It’s the name. And at least for the time being, I’m going to keep using it.
What About A Different Name?
The main problem that this community has had in coming up with a new name for this disease, in my opinion, is that they believe that the name needs to describe the disease rather than to just be a placeholder.
Imagine what the world would be like if all names were descriptors rather than placeholders. “Tall Spotted Long-Necked Animal (TSLNA).” “Beige Maned Carnivorous King of the Jungle Animal (BMCKOTJA)” “Striped Animal that Looks Like a Horse (SATLLAH).”
This is a disease with a very wide variety of symptoms, and there is relatively little agreement about which ones are the most important.
In addition, neither the underlying disease process nor the cause is as of yet understood.
It thus makes sense that describing the disease in a name would be a challenging task.
But many disease names don’t describe the disease at all – and hardly any describe the disease in plain English.
Therefore, saying a descriptive name in English – especially when it includes a concept perceived to be related to fatigue – automatically makes people suspect that it’s a bogus disease. Because it doesn’t sound anything like the names of diseases that they know to be serious.
This committee made it clear that what patients think of the name is important to them. They just don’t want to use “encephalomyelitis” because there’s not yet a definitive paper in the literature demonstrating that the brain inflammation for sure exists.
Insofar as the patient community stated that another specific name would be acceptable to them, and insofar as that name was not something that they would believe was misleading with regard to the current literature, I think that the committee very well might be willing to ditch this dumb name and adopt the better one.
Just as a starting point, many diseases are named after the doctors who were first associated with them or patients who have suffered from them or places where outbreaks initially occurred.
So perhaps we should be considering something like Ramsay’s Disease. Or BCP – Bell Cheney Peterson Disease. Or Florence Nightingale Disease. Or Sophie Mirza Disease. Or Vanessa Li Disease. Or Laura Hillenbrand Disease. Or Royal Free Disease. Or Lake Tahoe Disease.
The really great thing about a name with a story behind it would be that it would start conversations with people that would lead to an understanding of what the disease is actually like. Rather than having people dismiss the disease immediately because the name doesn’t sound serious enough.
Increasingly, I think that the people who have this disease have an enormous amount of latent power and that the main problem is that people are too sick and too demoralized to leverage it.
But I also think that if we worked as a community to come up with a great name – one that was a placeholder rather than a descriptor – we could do it.
And then we would have a disease with a name that we would feel proud saying out loud to our doctors and to others.
Not to mention, one that we could actually pronounce.
About the Author
Prior to becoming disabled with M.E. in 2001, Lisa Petrison earned her Ph.D. in marketing and social psychology from the Kellogg School of Management at Northwestern University and then worked as a business school professor at Loyola University Chicago.
She spent a dozen years as a mild/moderate patient and more than a year as a severe patient (as defined by the ICC) prior to regaining much of her health through mold avoidance and other treatments.
She now is the executive director of Paradigm Change.
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