Monday, July 7, 2014

Is CDC Out to Bury 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...."

What? 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. Every time I think CDC can't get more devious, the agency surprises me. 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. It's insanity. 

7 comments:

  1. I have suspected from the beginning of her time at CDC that she is only going through the motions of changing the deplorable history the CDC has in its attitude and treatment of those with ME.

    Thanks, Mindi!

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  2. It is astonishing how utterly detached from reality and blind to the glaringly obvious, Dr Unger proves herself to be - time after time after time. If she isn't working to a nefarious agenda dictated by her superiors, then this woman is clearly unfit to continue in the position which she currently holds.

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  3. Mindy,
    Thanks for posting this. If Unger knows about these things and goes ahead with a one-day test for PEM anyway, then I believe she is guilty of negligence and should lose her medical license.

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  4. Not sure if this is helpful, but...

    The NY Times health section has an article called, "The Well Guide to Activity Trackers" - to be updated "regularly as new trackers and features are tested." (Last updated 14 June 2014)

    From the CFS Central post above: "...using a pedometer like the Fitbit would also work...." And "...the authors cite actigraphy and pedometers for activity assessments."

    The NYT article actually mentions the Fitbit.

    Would it be helpful for the ME/CFS community to reach out to one or more of these companies? To explain how a device has helped/been particularly useful and how this usefulness is being threatened?

    Additionally, there's a website, Medical Device Daily, which seems to describe itself as the be-all end-all in medical device info.

    Also of note is that this publication was recently purchased by Thomas Reuters. And of further note, cortjohnson.org recently featured a Reuters piece questioning why ME/CFS is so poorly funded. (I haven't yet read either piece.)

    Maybe there's an opportunity somewhere in all of this?

    http://well.blogs.nytimes.com/projects/activity-trackers
    http://www.medicaldevicedaily.com/servlet/com.accumedia.web.Dispatcher?next=aboutUs
    http://www.cortjohnson.org/blog/201...alist-takes-chronic-fatigue-syndrome-ignored/
    http://blogs.reuters.com/edward-hadas/2014/06/11/market-failure-can-be-sign-of-fatigue/

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  5. mindy, thank you for bringing into clear light and writing so succinctly what i already knew but would have had trouble articulating. your research and summarizing is so valuable to us all. unger should be demanding to the CDC/NIH that a 2 day PEM study is mandatory, not spending her time arguing *against* doing it. she is clearly not on the side of the patients. ::sigh:: when will the tide turn for us? why is everything such a struggle? -- rivka

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  6. Thank you for reporting on this!

    I find it very odd that Unger seems to mean that "a consistent, validated way of measuring it that clinicians can use easily" is needed for a symptom to be included in a case definition. With that line of reasoning symptoms such as fatigue, pain, sore throat, headaches would also be unfit as criteria.

    This sounds unreasonable. Only diseases with measurable symptoms can be defined? Only symptoms that are easily measurable with current medical technology can be part of a case definition?

    Also, it's quite remarkable that Unger is claiming there is no validated way to measure PEM, when she herself has it in her power to validate the research on the 2-day CPET tests (Stevens Protocol) by Snell/Van Ness/Stevens and Keller by including the Stevens Protocol in the CDC multisite study (as the patient community has requested).

    /Anne Ortegren

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  7. The Open Medicine Foundation is raising money to start the End ME/CFS Project. They have top notch scientist and two Nobel Prize winners including James Watson ( as in Watson and Crick). You can find more information here http://www.openmedicinefoundation.org/

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