Trial By Error: The CDC’s Update for Healthcare Providers

By David Tuller, DrPH

Last summer, the US Centers for Disease Control removed graded exercise therapy and cognitive behavior therapy from its website as recommendations for treatment of the illness it was by then calling ME/CFS. Its stated explanation for the change–that readers had misunderstood the recommendations–was nonsense. Readers understood all too well what the agency meant by GET and CBT. The CDC’s related claim—that these were just generic disease management strategies and had nothing at all to do with PACE—was equally ridiculous. (The agency had previously removed references to the PACE trial while leaving the CBT/GET recommendations in place.)

Since then, the CDC has been promising to introduce a new section on information for healthcare providers. Earlier this month, after various consultations with stakeholders and a significant delay, it unveiled the long-promised section. Agency officials could have used the moment to do what they should have done way back: acknowledge the self-evident flaws of the PACE trial and apologize for the CDC’s central role in promoting the debunked claims of the CBT/GET ideological brigades. They didn’t, of course.

Putting that aside, how’d they do? Among advocates, the reviews seem to have fallen into two broad camps. Some found the new healthcare provider pages to be a mixed bag, and others thought they were a total disaster. The main difference was that the first group also found some positive as well negative aspects to the added material, especially when compared to previous CDC efforts. For example, the text conveys a better sense of the seriousness of the illness and highlights the central role of post-exertional malaise. I attribute any improvements to the hard work of the advocates who have tried to hold the CDC accountable in the face of enormous recalcitrance and resistance on the agency’s part.

Some patient-commentators whose opinions I respect have slammed the entire section, for a variety of reasons; from this perspective, any apparent changes for the better cannot be taken at face value. These critics have raised some legitimate issues—in particular about fuzzy language on exercise and about the agency’s reliance on the case definition created in a report from the Institute of Medicine, now the National Academy of Medicine. These concerns deserve attention. (I previously posted a Q-and-A with Leonard Jason, the DePaul University psychologist, in which he discussed concerns about the IOM case definition.)

Having said that, I agree with those in the mixed-bag group that some of the language represents a significant advance from prior iterations. (In the following quotes, the boldface phrases are from the CDC’s posted version.)

Here is the first sentence of the new section titled “Information for Healthcare Providers”: “Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a complex, chronic, debilitating disease with systemic effects.” The paragraph further states that “a hallmark of ME/CFS is that symptoms can worsen after physical, mental, or emotional effort, a manifestation known as post-exertional malaise (PEM).” Moreover, “as can be observed in people with other long-term chronic illnesses, secondary psychological symptoms such as depression and anxiety may also be present in some patients with ME/CFS.”

Reading that paragraph, healthcare providers without pre-existing biases or “dysfunctional cognitions” about ME/CFS should be able to grasp that this is serious biological illness, and that it can trigger some mental health distress. That is an important message to convey—whatever the problems with other aspects of the new material. (Of course, many healthcare providers do have pre-existing biases, thanks in large part to the CDC’s longstanding promotion of the CBT/GET paradigm.)

The section includes pages on, among other topics, clinical course of the illness, epidemiology, etiology and pathophysiology, diagnosis, and clinical care. Some of the language used is clear and direct, such as in this passage stressing the organic nature of ME/CFS:

“ME/CFS is a biological illness, not a psychologic disorder. Patients with ME/CFS are neither malingering nor seeking secondary gain. These patients have multiple pathophysiological changes that affect multiple systems. It is not known whether these changes occur prior to the onset of the illness or as its consequence.” The page then includes information about “immune system abnormalities,” “cellular metabolism abnormalities,” “neuroendocrine disturbances,” and “blood pressure or heart rate regulation abnormalities.” This is information that healthcare providers should know.

But major problems arise with advice about exercise, in the section on treating symptoms. These paragraphs include some appropriate warnings about the dangers of over-exertion, with one even rendered in boldface. But the sentences are also laced with phrases that reek of the biopsychosocial approach—“deconditioning,” “rehabilitation specialist,” “normal levels of activity,” “exercise physiologist,” etc. It is understandable that patients who have been urged by rehabilitation specialists and exercise physiologists to try to reverse their deconditioning by aspiring to normal levels of activity would be perplexed or alarmed by this terminology—especially when the writer of the passages demonstrates little awareness that the wording parallels the language used by CBT/GET proponents.

Here are the paragraphs in question:

“Any activity or exercise plan for people with ME/CFS needs to be carefully designed based on individual presentation with input from each patient. If possible, evaluation by a rehabilitation specialist may be beneficial. For some patients, even daily chores and activities such as cleaning, preparing a meal, or taking a shower can be difficult and may need to be broken down into shorter, less strenuous pieces. While vigorous aerobic exercise can be beneficial for many chronic illnesses, patients with ME/CFS do not tolerate such exercise routines. Standard exercise recommendations for healthy people can be harmful for patients with ME/CFS.

However, it is important that patients with ME/CFS maintain activities that they can tolerate, since deconditioning is also harmful to patients….Patients who are tolerating their current level of activity and have learned to “listen to their bodies” might benefit from carefully increasing exercise to improve their physical fitness and avoid deconditioning. Some healthcare providers with expertise in ME/CFS refer their patients to an exercise physiologist who understands ME/CFS and uses an individualized and flexible approach to advancing activity levels. If exercise plans are not designed and executed carefully, patients may experience setbacks and serious deterioration in function and health. Expectations need to be managed, as exercise cannot be expected to be a cure. However, improved function is a long-term goal of managing ME/CFS; tolerance of aerobic exercise and normal levels of activity is also a long-term goal that can be related to improved function, but should be pursued cautiously as described above.”

Mary Dimmock, a former pharmaceutical professional who turned to advocacy when her son fell ill several years ago, has long pressed the CDC to make changes to its website. Here’s what she wrote when I asked her about these exercise passages:

“The recommendations for exercise still include ambiguous recommendations to increase exercise and statements that could imply that only vigorous aerobic exercise is a problem. The site also implies that exercise might help achieve ‘tolerance of aerobic exercise and normal levels of activity.’ Collectively, the recommendations for exercise continue to put ME patients at risk of harm, especially given the prevalence of the GET narrative among doctors and the failure to include a discussion of the implications of aerobic metabolism impairment in the section on managing PEM.” (I have posted Dimmock’s full comments at the end of this post.)

These are excellent points. I assume the CDC’s aspirational language about long-term goals might be intended as a form of psychological encouragement, but the words seem to convey possibilities that outstrip the likely results for many patients. If the history of this illness is a guide, patients who do not achieve aspirational but unrealistic goals are susceptible to being stigmatized and criticized by healthcare providers for their perceived failures. That means public health agencies like the CDC need to bend over backwards to avert the likelihood of such consequences. The agency has failed in that obligation here.

Some advocates believe these passages represent a deliberate and covert CDC effort to sneak GET back into the approved playbook. I tend to believe health officials are moving in the right direction and know they need to keep moving in that direction, even if they’re moving way too slowly and are still sending mixed messages. But then I’m not a patient who has had to confront this crap for decades, so it’s easy for me to take a more charitable position.

Another key issue is the use of the IOM criteria. Many patients and researchers prefer the more detailed and specific ME/CFS Canadian Consensus Criteria from 2003 and/or a related follow-up, the ME International Consensus Criteria from 2011. Advocates have a number of concerns about the IOM definition, key among them that it does not exclude those with depression and anxiety, among other ailments. Since the symptoms of depressive and anxiety disorders can resemble and overlap with some of those that characterize ME/CFS, groups defined using this case definition will include an unknown number of people who might be suffering from depression or related disorders and not the organic illness purportedly being identified.

The IOM criteria were developed as a clinical case definition—that is, a guide for doctors and other healthcare providers to follow in diagnosing patients. That serves different needs than a research case definition, which is used to identify population samples for trials of interventions or other studies. Clinical case definitions can have broader boundaries because you want everyone who might possibly have the illness to be identified and treated, and it is not uncommon for patients to have multiple diagnoses. (This approach obviously presents its own set of problems if healthcare providers are not capable of making the appropriate and necessary diagnostic distinctions.)

In a study, you want to ensure that you have as homogeneous a population as possible so that you know you are studying the illness of interest and not something else. To date, CDC and the Department of Health and Human Services have shown little understanding of the urgent need to converge on a research case definition so that it is easier to compare studies. The new information for healthcare providers largely skirts the issue. But as patients and others have noted, applying the IOM case definition in research would yield populations more likely to include people with depression and other conditions that could overlap with ME/CFS, so it would be a challenge to interpret the results. Federal health officials must do better.

The CDC is scheduled to meet again with stakeholders to discuss the new pages for healthcare providers, so I assume there will be updates down the line. I look forward to improvements and clarifications in the next version.

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The CDC’s release of this new information for healthcare providers has triggered a petition urging the CDC’s parent agency, the U.S. Department of Health and Human Services, to adopt the 2011 ME-ICC definition for all purposes: https://www.change.org/p/the-us-department-of-health-and-human-services-cdc-adopt-the-distinct-disease-myalgic-encephalomyelitis-me-as-defined-by-icc-now

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Mary Dimmock’s e-mailed comments about the CDC’s new section on information for healthcare providers:

In July 2018, the CDC updated its website to include information for healthcare providers. In general, the site is a significant improvement over CDC’s earlier materials for healthcare providers. The site explicitly states that this is a not a psychological illness but a biological illness that affects multiple systems, including the immunological, autonomic, and energy metabolism systems. The site emphasizes impaired function, the hallmark symptom of post-exertional malaise (PEM) and the importance of avoiding the harm that can result exceeding one’s available energy. The treatment section does not explicitly recommend CBT and GET and stresses that people with ME do not tolerate the exercise routines that people with many other chronic illnesses can. Noting the lack of FDA approved treatments, the site states that the goal or treatment is symptom relief and improving quality of life. Finally, the site explicitly acknowledges the medical community’s lack of knowledge and acceptance of ME.

But there are significant areas that need to be improved to better inform medical providers. First, PEM needs to be more specifically described both as a symptom and in terms of what is known about the associated energy metabolism impairment. This is the essence of ME and if doctors don’t get this, they don’t get ME, they can’t diagnose it, and they are more likely to mistreat it. Further, while CDC has removed explicit recommendations for CBT and GET and the PEM treatment section speaks about the need for each patient to avoid exceeding their energy limits, the recommendations for exercise still include ambiguous recommendations to increase exercise and statements that could imply that only vigorous aerobic exercise is a problem. The site also implies that exercise might help achieve “tolerance of aerobic exercise and normal levels of activity.” Collectively, the recommendations for exercise continue to put ME patients at risk of harm, especially given the prevalence of the GET narrative among doctors and the failure to include a discussion of the implications of aerobic metabolism impairment in the section on managing PEM.

The guidance on differential diagnosis must also be improved. The IOM clinical diagnostic criteria used on the site have been criticized for not excluding conditions with similar and overlapping symptoms. The introduction of this case definition has shifted the process of identifying clinical patients from a diagnosis of exclusion to a positive diagnosis that also allows for them to have more than one disease at a time. Presumably, a person with depression could later develop another condition, in this case ME. But ME has often been conflated with psychiatric illness or somatoform disorder. Therefore, the CDC must provide much more explicit guidance on differential diagnosis for primary psychiatric illness and the case definition should explicitly exclude somatoform disorder.

There are a number of other areas that need to be improved on the website. These include a) strengthening the section on the severely ill to adequately convey what the most severely ill experience, b) revising the prognosis section to reflect the decades-long reality endured by patients, c) including the widely evidenced neurocognitive and neurological impairment in the section on disease pathology, d) removing “emotional trauma” as a trigger of the disease, given the IOM’s rejection of this as a trigger or risk factor and e) removing the reference to the Alberta Guidelines, which continue to recommend CBT and GET. The site must also include rheumatologists, immunologists, neurologists, and other medical specialists, rather than focusing on “rehabilitation specialists, mental health professionals, and physical therapists.” Focusing on rehabilitation specialists and mental health professionals reinforces the current false medical narrative about the nature of the disease and does nothing to pull in the specialists who will be needed to address the biological complexity of the disease and the GP’s limited time.

Finally, the CDC needs to directly address the problem of stigma and disbelief that continues to pervert the quality of clinical care that people with ME experience. This website is a start but is far short of what is needed to quickly change the negative medical narrative that has caused such harm to people with ME. To change this narrative, HHS must undertake a program of direct, proactive and multi-pronged engagement of the medical community.

Comments on this entry are closed.

  • Claudia Heath 30 July 2018, 7:50 pm

    Thanks. This is very useful analysis. My personal beef is with the shocking prognosis section as you list as point b). A medical professional reading this, while having clearly seen how serious ME can be, could still easily regard it as likely to be shortlived. No mention of lengthy timeframes or the pitifully small recovery rate.

  • Colleen Steckel 3 August 2018, 12:34 pm

    When discussing any criteria, focus has been on getting diagnosed or selecting patients for research. What is repeatedly ignored is what is the end result for patients when any criteria are used.

    We’ve seen for over 20 years what treatment for those who were diagnosed with CFS and then ME/CFS received due to the Fukuda definition. Treatment was psychological and exercise based. While the terms CBT and GET have been taken off the CDC website, very little has changed for the patients.

    The current discussions centering around the IOM, in my opinion, have missed taking into account what main stream doctors will do for patients. As a support group leader who meets locally and online with many patients ranging from mild to severe I am still hearing that doctors have no understanding about ME being an immune system disease with cardiac involvement or addressing the neurological damage. Paralysis for the severe patients is continually ignored leaving patients with no way to get the proper understanding from their doctors or their family. Paralyzed patients being slapped across the face and told to snap out of it is still happening. That is lack of education plain and simple.

    We’ve seen the studies and know that using the IOM just as with the Fukuda many people who don’t fit the expert’s criteria are being diagnosed with ME/CFS. Treatments for those patients may very well be appropriate as behavior modification driven. Behavior modification is inappropriate for someone who is so ill they have no control over their daily living – no “modification” is possible.

    I support the ICC petition because I am tired of patients being told the following:

    You are on your own and to cope as best you can.
    Get used to this there’s nothing we can do.
    You are just overreacting to normal stimuli – therapy will help.
    You need to eat healthier and lose some weight
    You spend too much time in your bed / room / house. Get out and socialize.
    You have to move more – use it or lose it.
    Gradually increasing exercise will get you well again.
    You’ll get better eventually if you just…..

    All those are based on blaming the patient or leaving it up to the patient.

    Nothing I have seen in the IOM will change this treatment from doctors.

    The ICC lists many tests and treatments that the EXPERTS who have treated thousands of patients have put into practice. Ignoring the experts in favor of leaving the patients to fend for themselves is not in the best interest of the patients’ improving their quality of life.

    I have seen that many specialists have praised the IOM because they are happy that now more doctors can take on the job they have been stuck with of diagnosing patients. But what about that next step.

    Where will all those now diagnosed with ME/CFS go for treatments?

    The primary care doctors’ course of action will continue to be to leave it up to the patients to modify their behavior – pace better – eat better. When those patients realize that all the pacing and diet changes in the world are ineffective against ME, they will be flocking to the specialists who have developed treatments to improve quality of life. The few experts we have left already have year long waiting lists. This is a recipe for disaster.

    By adopting the ICC our general practice doctors will have the understanding this is not a simple disease that patients can handle on their own. They will push for specialists who can take referrals.

    We deserve the same as an RA patient going to a specialist or an MS patient going to a specialist. It is time patients finally received proper care and, in my opinion having been sick 29 years this month. only the experts’ criteria (CCC or ICC) is going to lead to that outcome.

  • Janet Dafoe 5 August 2018, 5:32 am

    We don’t agree that the IOM criteria would include people with depression and anxiety who don’t have ME/CFS. People with depression and anxiety do not have PEM. PEM is necessary for an ME/CFS diagnosis using the IOM criteria. Of course people with ME/CFS might also be depressed but not necessarily. People can have both diagnoses. But PEM is necessary for a diagnosis of ME/CFS so using IOM criteria would not result in cohorts of patients without ME/CFS but only depression.

  • Colleen Steckel 5 August 2018, 12:13 pm

    When discussing any criteria, focus has been on getting diagnosed or selecting patients for research. What is repeatedly ignored is what is the end result for patients when any criteria are used.

    We’ve seen for over 20 years what treatment for those who were diagnosed with CFS and then ME/CFS received due to the Fukuda definition. Treatment was psychological and exercise based. While the terms CBT and GET have been taken off the CDC website, very little has changed for the patients.

    The current discussions centering around the IOM, in my opinion, have missed taking into account what main stream doctors will do for patients. As a support group leader who meets locally and online with many patients ranging from mild to severe I am still hearing that doctors have no understanding about ME being an immune system disease with cardiac involvement or addressing the neurological damage. Paralysis for the severe patients is continually ignored leaving patients with no way to get the proper understanding from their doctors or their family. Paralyzed patients being slapped across the face and told to snap out of it is still happening. That is lack of education plain and simple.

    We’ve seen the studies and know that using the IOM just as with the Fukuda many people who don’t fit the expert’s criteria are being diagnosed with ME/CFS. Treatments for those patients may very well be appropriate as behavior modification driven. Behavior modification is inappropriate for someone who is so ill they have no control over their daily living – no “modification” is possible.

    Note: Original posting of this was removed – reposting in sections. Continue reading in comments.

  • Steve Coleman 17 August 2018, 9:50 am

    The CDC has big problems going well beyond just ME/CFS. I am dying of a disease called Dirofilaria that the CDC thinks is not a problem for humans. There is no test for the disease in humans so their *assumption* is that it does not exist. No, what it means is that they are blind to the problem. Because it is also (mostly) asymptomatic, I knew I was sick, but nobody could tell me why, for twenty+ freaking years!

    After a lot of personal research in published scientific journals, now I know what that problem is, but because of what wonderful “advise” the CDC has for medical practitioners online I can’t even find a knowledgeable doctor that will voluntarily see me. I have been flat out refused the right to schedule an appointment at one major medical institution’s clinic, who employed two of the only parasitologists in the state that I could find. Another infectious disease doctor, whom is not a parasitologist, after looking up the CDC’s wonderful “advise” for practitioners, told me point blank: “Even if you could prove to me that you have dirofilaria I still would not treat you for it”.

    Since then purchased my own lab equipment, and I took hundreds of photographs of this parasite using simple H&E stained blood smears under my own microscope, and I still am having a problem getting an appointment with a qualified doctor. Today I should be hearing back from the same institution that rejected me once before, with a new referral and photographs, hopefully they will change their minds and accept me, if they even bothered to look at the photographs that are now a part of my official medical record. I have been waiting for that phone call 10 days now, and almost got taken to the ER last weekend.

    If it were not for the CDC’s wonderful advise I might have been treated for this over a year ago. In the mean time I have since adopted a “rescue” dog, that tested positive for dirofilaria, we treated him, and he is now doing just fine. I on the other hand have had to do all my own research, diagnostic investigation, and I still can’t find a doctor that will even attempt to *verify* my proven infection. My own PCP contacted the CDC for advise on getting a diagnosis, and they basically said ‘call back when you get a diagnosis’ and we will talk to you.

    There may be no test for dirofilaria in humans, but I will logically assert that ‘the Absence of Evidence is not Evidence For Absence’. Never assume that what you don’t understand is not possible. To do so only highlights your ignorance.