IOM Report: Remarkably Positive for ME patients

The IOM report is in, and it’s remarkably positive for ME patients. The IOM committee has proposed a new name for ME: Systemic Exertion Intolerance Disease or SEID. OK, it’s a mouthful, and how do you pronounce the acronym? It’s possible that disbelievers will morph the name into: You’re Just Too Lazy to Exercise. Which no one would do had there not been the idiotic Chronic Fatigue Syndrome moniker for thirty years, drumming into the public’s collective head that sufferers had nothing really wrong with them, except perhaps indolence.

All that being said, SEID beats Chronic Fatigue Syndrome by a mile, and it trumpets—at long last—the most critical piece of this complex and catastrophic disease:  post-exertional collapse.

From the press release, issued along with the 235-page report: 

Diagnosis of ME/CFS requires that a patient have the following three core symptoms:

A substantial reduction or impairment in the ability to engage in pre-illness levels of activities that persists for more than six months and is accompanied by fatigue—which is often profound—of new or definite onset, not the result of ongoing excessive exertion and not substantially alleviated by rest

The worsening of patients’ symptoms after any type of exertion—such as physical, cognitive, or emotional stress—known as post-exertional malaise

Unrefreshing sleep

At least one of the two following manifestations is also required:

Cognitive impairment

The inability to remain upright with symptoms that improve  when lying down—known as orthostatic intolerance

These symptoms should persist for at least six months and be present at least half the time with moderate, substantial, or severe intensity to distinguish ME/CFS from other diseases

Astonishingly, especially given CDC’s long misplaced obsession with cognitive therapy, the IOM paid little attention to it, the major paragraph registering barely a whimper: “The efficacy of cognitive-behavioral therapy (CBT) in improving cognitive function in ME/CFS patients is unclear. Knoop and colleagues (2007) found a decrease in self-reported cognitive impairment following CBT, yet ME/CFS patients did not differ from a support control group on results of the subscale of alertness behavior of the Sickness Impact Profile (SIP-ab). These results do not preclude the use of CBT to mitigate cognitive impairment in ME/CFS, but do suggest that any effects of CBT may not be measurable by a single scale such as the SIP-ab.” 

Here are the committee's recommendations:

Recommendation 1: Physicians should diagnose myalgic encephalomyelitis/chronic fatigue syndrome if diagnostic criteria are met following an appropriate history, physical examination, and medical work- up. A new code should be assigned to this disorder in the International Classification of Diseases, Tenth Edition (ICD-10) that is not linked to “chronic fatigue” or “neurasthenia.”

Even if patients do not meet the criteria for this disorder, clinicians should address their symptoms and concerns. Patients who have not yet been symptomatic for 6 months should be followed over time to see whether they meet the criteria for ME/CFS at a later time.

Recommendation 2: The Department of Health and Human Services should develop a toolkit appropriate for screening and diagnosing patients with myalgic encephalomyelitis/chronic fatigue syndrome in a wide array of clinical settings that commonly encounter these patients, including primary care practices, emergency departments, mental/behavioral health clinics, physical/occupational therapy units, and medical subspecialty services (e.g., rheumatology, infectious diseases, neurology).

One failing of the report is that the recommendations don’t include the pressing need for more research and funding into the disease. But later in the report the committee does touch on this failing: “Remarkably little research funding has been made available to study the etiology, pathophysiology, and effective treatment of this disease, especially given the number of people afflicted. Thus, the committee was unable to define subgroups of patients or even to clearly define the natural history of the disease. More research is essential.”

The inclusion of the word “remarkably” is especially welcome.

The report addresses accurate economic costs of this disease: “The direct and indirect economic costs of ME/CFS to society have been estimated at $17 to $24 billion annually (Jason et al., 2008), $9.1 billion of which has been attributed to lost household and labor force productivity (Reynolds et al., 2004). High medical costs combined with reduced earning capacity often have devastating effects on patients’ financial status.”

The IOM addresses pediatric ME as well.  From the report: “There is sufficient evidence that orthostatic intolerance and autonomic dysfunction are common in pediatric ME/CFS; that neurocognitive abnormalities emerge when pediatric ME/CFS patients are tested under conditions of orthostatic stress or distraction; and that there is a high prevalence of profound fatigue, unrefreshing sleep, and post-exertional exacerbation of symptoms in these patients. There also is sufficient evidence that pediatric ME/CFS can follow acute infectious mononucleosis and EBV.”

BOUGHT

Bought is a terrific new documentary about the health dangers of vaccines, prescription drugs and genetically modified foods. The film is hosted by outspoken Evanston, Illinois, physician Toni Bark, who’s treated in her own medical practice children who’ve been injured by vaccines. Some ME patients have had their own disease brought on by vaccination, particularly hepatitis B.

One of the many frightening things that I learned from the film is that some GMO foods have, among other alarming facts, the ability to destroy gut bacteria. Since most of the immune system is in the gut, disruption of gut flora may have problematic health consequences. (Basically, in a twist on the 1970s commercial for Chiffon margarine, it's not nice to fool Mother Nature.)

As the title of the film makes crystal clear, money, greed, corruption and sociopathy rule in big pharma, whereas people’s health is an afterthought—if that. And since CDC essentially works for pharma, and physicians trust CDC to give them accurate information, physicians and the public are comforted, the physicians into believing they're doing the right thing, and the public into believing that it's safe. But the film argues that in fact people, particularly children, have become the canaries in the coal mine.  

The good news is that people are starting to wake up to the fact that they’ve got to fight for their own health and the health of their children. Bought documents how advocates in Connecticut fought for GMO labeling on food—GMO manufacturers have been campaigning vigorously against it—and in 2013, the state became the first to pass a bill to require companies to label products that contain GMOs.

The film is available to stream for $4.95 until November 21 at boughtmovie.com. You can watch the trailer here:

CDC AND PEM

CDC's head of CFS research Dr. Beth Unger said at last month's Chronic Fatigue Syndrome Advisory Committee meeting that she couldn't figure out how to measure post-exertional malaise (PEM)--the hallmark of ME--and thus believes problems would ensue if PEM is a mandatory symptom. 

"My concern about making post-exertional malaise an absolute criteria for diagnosis is if you don't have a consistent, validated way of measuring it that clinicians can use easily, it's big barrier," Unger explained at the meeting. A few minutes later, when committee member Donna Pearson asked again about PEM being included in the criteria, Unger replied, "I think everybody agrees that it's very characteristic and a very important symptom, and clinicians will tell you that they can recognize it, they can elicit this information from patients, but to make that quantifiable and to make it easily implementable is another question...."

Several researchers have shown how to measure PEM.  Cardiac pulmonary testing used by Dr. Chris Snell is one way, gene expression testing devised by Drs. Alan and Kathleen Light is another, comprehensive patient history is yet another, and using a pedometer like the Fitbit would also work. Dr. Jose Montoya conducted VO2 max studies with patients on the antiviral Valcyte to determine if their exercise tolerance improved on the antiviral. Unger's familiar with all of this. In fact, Unger is one of the authors of a 2012 paper, "Minimum data elements for research reports on CFS," in which the authors discuss how to measure PEM:  

"As post-exertional malaise is a key symptom of all CFS case definitions, it would be appropriate to measure the extent of activity and how such activity might result in symptoms of fatigue and malaise. Light et al. (2009) found patients with CFS demonstrated increases after exercise that reliably exceeded responses of control subjects in mRNA for genes receptors that can detect muscle produced metabolites, genes that are essential for sympathetic nervous system processes, and immune function genes. The researchers concluded that CFS patients might have enhanced sensory signal for fatigue that is increased after exercise. Activity, or in work performed is generally quantified in terms of energy used, i.e., caloric expenditure. Because this is difficult to measure during activity, total oxygen consumption which increases in a similar fashion, is typically used in its place. 

"Sometimes represented as METs or metabolic equivalents, oxygen consumption may be assessed directly using cardiopulmonary exercise testing with measured gas exchange (Milani et al., 2006), or estimated from heart rate or other indicators of effort such as time and/or distance travelled. Assessment of effort is critical when exercise is used as a physiological stressor to elicit symptoms in CFS patients or for assessments of functional capacity as part of clinical trials. Heart rate as a percentage of age-predicted maximum is the most recognized indicator of subject effort for both maximal and submaximal exercise protocols. However, the maximal heart rate response to exercise varies widely in the general population (Balady et al., 2010) and has been shown to be blunted in some subjects with CFS (e.g., VanNess et al., 2003) and also in fibromyalgia (Ribeiro et al., 2011). 

"As an alternative to heart rate, the peak respiratory exchange ratio (RER) is acknowledged as the most valid and reliable gauge of subject effort (Balady et al., 2010). Because it can only be obtained from ventilatory expired gas analysis, RER may not be available in all exercise studies. Similarly, submaximal exercise protocols do not provide for the measurement of peak RER. In such instances selecting alternative measures that can accurately assess effort both within and across subjects is particularly important."

In addition, in Table 2 in the paper, the authors cite actigraphy and pedometers for activity assessments. 

Thus, Unger knows how to measure PEM. So why is CDC trying to bury PEM? After all, PEM is the most important symptom of the disease--and PEM distinguishes ME patients from people diagnosed with CFS who in reality are just depressed. But maybe that's the point. To lump bona fide ME patients in with the depressed.  That way you don't get meaningful data or treatment, and the band plays on. 

First, Unger nixed a two-day exercise test in favor of a one-day test, even though Dr. Chris Snell has shown PEM isn't apparent until the second day of testing. And now Unger can't figure how to measure PEM. If Unger is hung up a "consistent, validated way" of measuring PEM, she only has herself to blame for not having done a two-day exercise test after all these years. Leaving off PEM in the definition is like omitting elevated blood sugar in diabetes or a depressed CD4 count in AIDS.