To: Dr. Francis Collins, Director of NIH
Keep Psychiatry Out of NIH Study on ME/CFS
This campaign has ended.
None of the 40 patients brought into the upcoming in-house NIH study of ME/CFS should have been, or concurrently be capable of, a diagnosis of:
* Major mood disorders, concurrent depression or concurrent anxiety
* Medically Unexplained Symptoms (MUS)
* Somatic Symptom Disorder (SSD)
* Major psychiatric disorders
* Somatoform disorders
Why is this important?
This is the first study on ME/CFS conducted by NIH in two decades. One million patients suffer from this disease, too long neglected by both CDC and NIH. At any point in time 500,000 American ME/CFS patients cannot work at all; one-fourth can only work part-time and one-fourth can work full time, but it is unclear what else they can do as a result. Other studies have suggested that at least 250,000 Americans are bedridden and/or homebound by ME/CFS. Patients deserve the best study NIH can give them, not a replay of outdated psychiatric theories.
It is critical that the Principal Investigators recognize existing biomedical research on the disease, as well as the results of recently commissioned studies by the Institute of Medicine for DHHS and the P2P (Pathways to Prevention) program at NIH.
Finally, there will only be 40 patients in this study. Given the complexity of this disease, it is imperative that the 40 patients chosen actually have ME/CFS.
We are concerned that the "expert committee" does not contain experts on ME/CFS as a biomedical condition. The Lead Associate Investigator (LAI), who will "coordinate screening of potential participants" according to NIH, published an article last year which stated "The discordance between the severity of subjective experience and that of objective impairment is the hallmark of somatoform illnesses, such as fibromyalgia and chronic fatigue syndrome."
Any consideration of "chronic fatigue syndrome" as a "somatoform illness" is inappropriate. As the IOM study clearly stated, patients have long suffered from "the misconception that [ME/CFS] is a psychogenic illness or even a figment of the patient's imagination." [p. 2, IOM Report, 2015] Similarly, the P2P committee stated, "Both society and the medical profession have contributed to ME/CFS patients feeling disrespected and rejected. They are often treated with skepticism, uncertainty, and apprehension and labeled as deconditioned or having a primary psychological disorder. " [p. 4, P2P Report, 2015]. The P2P Report further stated, "Although psychological repercussions (e.g., depression) may accompany ME/CFS, it is not a primary psychological disease in etiology. ... Although focusing on fatigue alone may identify many ME/CFS cases, it does not capture the essence of this complex condition." [p. 5, P2P Report, 2015]
Dr. Walitt should not be on the study, let alone be the Lead Associate Investigator.
The four other named "experts" on the committee include:
* Dr. Elizabeth Unger from CDC, who has told patients that "cognitive behavior therapy and graded exercise" are "scientific" and would remain on CDC's website despite the IOM report;
* Dr. Fred Gill, who recommends counseling and exercise in his most recent NIH/CDC educational video on the disease and seems unaware of the current literature on biomedical abnormalities in ME/CFS;
* Dr. Leorey Saligan, who considers himself an expert on "fatigue" and states he is "investigating the relationship of fatigue with other behavioral symptoms including pain, sleep, depression, anxiety, and catastrophizing."
The fifth "expert" on the committee is Dr. Ian Lipkin of Columbia University, who is a world-renowned expert on viruses and immune systems. Dr. Lipkin has recently published studies involving immune abnormalities in ME/CFS. He is a researcher, however, not a clinician.
With the exception of Dr. Lipkin, the team of "experts" represents a very narrow view of the disease the study is supposed to examine. Most baffling, the choice of experts runs counter to the IOM report commissioned by HHS, and the P2P report commissioned by NIH. Contrast the emphasis on fatigue, somatoform disorders, and catastrophizing with this recent survey of the literature by DePaul psychologist Leonard Jason: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4761639/
We might also recommend the extensive bibliography in the 275-page report on ME/CFS by the Institute of Medicine.
Again, as emphasized by both IOM and P2P studies, this disease is not characterized by "fatigue" but by Post-Exertional Malaise (worsening of symptoms), sleep disruption, cognitive dysfunction and orthostatic intolerance. That is not a question to be determined by NIH, but rather a requirement for diagnosing the patients. Indeed, it is difficult to ascertain just where the current study would fit within the recommendations of the P2P.
The Canadian Consensus Criteria is even more restrictive in diagnostic criteria, yet it appears that patients would only be tested for these criteria after having already been chosen for the study. For example, we are baffled as to why the two-day CPET exam is not a requirement for inclusion - there certainly exist sufficient evidence of its value at measuring both the severity of the disease, and the tell-tale symptom of PEM.
We would like reassurance in writing that no psychiatric conditions (as described in the petition) will be considered in this study, and we ask for those who specialize in "fatigue," "somatoform disorders," and "catastrophizing" not be included at all. They need to be replaced by known ME/CFS experts such as Leonard Jason, Dan Peterson, Sue Levine, Nancy Klimas, and José Montoya.
We request written confirmation that the questionnaires devised by the late William Reeves, Elizabeth Unger, et al to diagnose the Atlanta and Georgia cohorts not be used in connection with this study. They bear too close a resemblance to the "Oxford definition," which the P2P report recommended be retired. [p. 16, P2P report]
This study has enormous repercussions for one million patients in the US and over 12 million patients worldwide. Please give these patients the respect of restricting the study to biomedical evidence. As the P2P report concluded: "Patients must be at the center of the research efforts, and their engagement is critical."