January 14, 2015
By Lisa Petrison, Ph.D.
Like many in the ME community, I continue to believe that the NIH P2P initiative is likely to result in an entirely unhelpful outcome for individuals with this disease and that firmly protesting its existence has been the right strategy.
Following are some comments that I am sending to the committee and to a number of government officials pointing out some of the biggest problems that I have with the recently released draft version of the committee’s report.
The whole comment may be read in PDF format as well.
This draft version of their report probably will be be removed from the government site after the comment period ends at the end of this week, and so for future reference, I am storing a copy on this website as well.
DATE: January 12, 2015
TO: Sylvia Burwell; Francis Collins; Tom Frieden; Susan Maier; David Murray; Wanda Jones; CFSAC; P2P committee.
FROM: Lisa Petrison, Ph.D.
RE: NIH P2P Report on “ME/CFS”
Following is a list of some of the most important problems that I see in the recent draft report from the NIH P2P committee charged with looking at “ME/CFS.”
First, the opening sentence is misleading, inconsistent with the comments in the rest of the report, and factually inaccurate.
“Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a chronic, complex, multi-faceted condition characterized by extreme fatigue and other symptoms that are not improved by rest.”
This makes it seem like the most important thing that people should know about ME is that it consists of “fatigue” (plus other symptoms that aren’t important enough to mention specifically).
Especially considering the historical characterization of the disease as “chronic fatigue syndrome,” this introductory statement will encourage physicians, researchers, government officials and others to continue to overlook the much more critical health problems that patients with ME face.
I request that the first sentence be rewritten to include specific mention of some of the more debilitating issues of ME, including cognitive dysfunction, orthostatic intolerance, pain, inability to tolerate a wide variety of environmental stimuli, and post-exertional relapse.
Second, the word “fatigue” used in the first sentence and then throughout the document is not an appropriate characterization of any of the health issues that people with ME endure.
Ever since the Lake Tahoe epidemic in the mid 1980’s, severely ill patients have repeatedly tried to make medical professionals understand that describing their profound lack of ability to participate in normal activity as “fatigue” is as inappropriate as saying that the limitations that ALS patients experience are due to “fatigue.”
The activity-limiting state experienced in this disease is nothing like what healthy people ever experience when they are tired or fatigued. It is much more like paralysis or like the feelings of inflammation that people experience when they are fighting the flu.
Research literature now demonstrates that ME patients indeed have abnormal physiological markers (including gene and heat shock protein expression, low cerebral oxygenation, inflammation, oxidative stress and C4a complement levels) subsequent to activity. (1)
Healthy people do not display these same markers no matter how much exercise they’ve done, how hard they’ve been working, or how little sleep they’ve been getting.
People with ME are ill, just as people with a bad case of the flu or with ALS are ill. This is not the same thing as being fatigued.
In addition to being an inaccurate description of ME patients’ health problems, the word “fatigue” (by any definition) is not specific enough to be used as a primary descriptive symptom for this disease or for any other disease.
People with cancer, AIDS, Parkinson’s, ALS, MS and many other conditions also experience an enormous decline in their ability to be active, for instance.
It would be wholly inappropriate for the government to point to “fatigue” as the defining symptom of any of those diseases. And it is wholly inappropriate for the government to continue to focus on “fatigue” as the defining symptom for ME.
I request that it be noted in the report that the problems that force ME patients to limit their activity appear to be nothing like the fatigue that healthy people experience.
I also request that the report suggest that the use of the term “fatigue” to characterize this disease may be inappropriate in general.
I further request that the focus on “fatigue” be decreased throughout the report. For instance, it could replace the mention of “fatigue” in the first paragraph with a comment about patients having “an abnormally limited ability to participate in physical or mental activity.”
Third, positive governmental action toward this disease seems more likely if specific funding recommendations are provided in the report.
The primary stumbling block in terms of advancement for ME now is that there has been very limited governmental research funding in the past – and that virtually all of the available funds have been wasted on poor-quality projects.
I request that the report elaborate on the extent to which this disease has historically been underfunded.
Further, I request that the report suggest a specific NIH dollar figure that would provide a chance for scientific progress and that would be similar to the amount being spent on similarly devastating diseases (such as MS, autism, lupus, Parkinson’s or Alzheimer’s).
I also request that the report recommend that funding needs to go toward high-quality biomedical research projects, with primary emphasis on severely ill subjects.
Fourth, discussion in the report needs to be directed toward the relationship between ME and CFS, and should not be referring to the artificial construct of “ME/CFS” as if it has any scientific basis behind it.
“ME” has been an established disease since the 1950’s, with many articles on illness outbreaks published in prestigious journals. It has had a quite consistent definition since that time.
Existing definitions of “ME” point to a specific group of patients who are very ill and who have a recognizable pattern of specific symptoms.
“CFS” was created by a CDC committee during the late 1980’s. It has been characterized by a variety of non-specific definitions, none of which look much like the descriptions of ME from the literature.
Existing definitions of “CFS” point to a very broad group of individuals, including many people who are only very mildly sick and experience only non-specific symptoms rather than the ones repeatedly reported to be characteristic of ME.
In 2012, the CDC website suggested that ME and CFS were different conditions, stating: “The name myalgic encephalomyelitis (ME) was coined in the 1950’s to clarify well-documented outbreaks of the disease; however, ME is accompanied by neurologic and muscular signs and has a case definition distinct from that of CFS.” (2)
“ME/CFS” is a term that first began being used by the government a little more than a year ago. It is of particular concern to many in the ME community because of the possibility that it may be interpreted as stating that ME is just another name for the government’s badly named and badly defined “CFS” concept.
I wrote about this topic in a brief comment to the CFS Advisory Committee to the DHHS last month. (3)
I request that the report bring up the idea that establishing an official disease of “ME” using an appropriate definition for those who have ME (rather than forcing those people to be diagnosed as having the non-specific non-disease of “ME/CFS”) might help to clear up some of the current confusion about the definition and move scientific progress forward.
Fifth, the continuing discussion of papers using only the Oxford definition as if the findings of those papers have any relevance whatsoever to ME patients needs to be put to a halt.
The report acknowledges that the Oxford definition is flawed. Every “ME/CFS” specialist and every ME patient I know wholeheartedly agrees with that.
I thus request that the report state that any published work done using only the Oxford definition should not be assumed to be applicable to people with ME, unless and until that research is replicated with a subject population selected using a less flawed definition.
Thank you for your attention to these issues.
Lisa Petrison, Ph.D.
(1) Background information on medical abnormalities in ME or CFS.
(2) CDC 2012 website page discusses the difference between “ME” and “CFS.”
(3) Statement on “The Problem with “ME/CFS.”
Comments on the P2P draft report will be accepted until Friday, January 16. This link provides instructions for submitting comments.
However, it is important to note that these comments will be read only by the committee members and will not be retained by the government.
I sent my letter to the following list of government officials as well.
NIH Director Francis Collins (firstname.lastname@example.org)
CDC Director Tom Frieden (email@example.com)
I also will be providing a copy of the letter to the library of commentary that Jennie Spotila is maintaining on her blog.
ME Advocacy is collecting letters opposing the whole P2P process on its site and is working on a petition to demonstrate that the community is still in opposition to the effort.
I would like to thank Liz Willow for providing the 2012 screenshot of the CDC website, and also those advocates who kindly provided feedback on this comment before its submission.
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