The petition to "Keep psychiatry out of the NIH study on ME/CFS study" is popular; it's gotten about 2,300 signatures and on the face of it, it makes sense. Who, after all, wants psychiatry in the largest NIH study ever done on chronic fatigue syndrome? I certainly don't. That's the last thing I want in a study we're hoping will help build a foundation for the next era of research into this illness.
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[/fright]I question, though, whether the petition has done much good. I am not questioning the petitioners commitment to supporting people with this disease. Their commitment is clear. I am questioning some assumptions that I believe underlie the petition and the veracity of some of the statements in the petition.
The petition begins by indirectly asserting that the study creators don't recognize or are willing to use the existing biomedical research into this illness to inform the study.
P2P Mismatch?
The petition also states the study doesn't fit the P2P guidelines:
Much of the study design, however, could have come straight out of the report. In fact, in many places Dr. Nath's study goes considerably further than the P2P report proposed. The P2P report recommended that:
The Nath study:
The petition focuses on the membership of the "executive committee". It's not exactly clear what the executive committee will be doing - that is something of an area of concern. At this point they seem to be assessing whether the patients in the study meet the simple criteria for the study (infectious onset, meet the CCC, early duration patients) and giving them some initial questionnaires.
The makeup of the executive committee is not ideal but consider that the NIH was probably picking from a relatively small pool of doctors and researcher who were associated with the Clinical Center and could be on site to assess the patients.
The petition highlighted strikes against each of the members of the Executive Committee (except for Dr. Lipkin). While I understand the angst over having anyone that supports CBT/GET in the study, I question what that means.
Dr. Gill
In a 2011 NIH presentation Dr. Gill associated ME/CFS with neurasthenia (is that inaccurate?), cited findings which did not show evidence of viral infections or orthostatic intolerance, and of stating that CBT is helpful. He suggested the positive test results from unproven tests (such as viral tests) were likely to be false positive, then cites several pages of unproven treatments and ends stating that CBT/GET are the only therapies shown to provide meaningful benefit.
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[/fright]He also proposed that studies elucidating the neuro-immune-endocrine study and immune gene expression could turn out to be very helpful. He stated that there is typically no history of somatic disorders such as headache and low back and that the average ME/CFS patient was typically highly functioning before they were "struck down". He also said that the depression found in ME/CFS is "secondary"; i.e. it's not a primary feature of the disease.
He advised that physicians emphasize that ME/CFS is a real illness, that it is not malingering and that it can be completely incapacitating. They should inform the patient that even though they do not know the cause of ME/CFS (or as he repeated mispelled it CSF) have good treatments for it that they can help.
There are several things in there that might really tweak one. The key question is whether the fact that a doctor supports behavioral treatments means that he believes ME/CFS is a behavioral disorder? Or could it mean that he/she's just a conservative physician?
Gill states that ME/CFS is not depression, that it is a real illness and that the medical profession simply doesn't know the cause or have good treatments for it.
A look at Dr. Gill's background suggests that psychiatry might be the last thing on his mind. Dr. Gill is an internal medicine and infectious disease specialist and his publications focus almost exclusively on the immune system.
I leave open the possibility that Dr. Gill believes CBT/GET helps, and that that belief in no way conflicts with his idea that ME/CFS is also a real and serious, physiologically based disorder. At the end of the presentation he proposed that neuro-endocrine-immune and immune gene expression studies under way might provide clues to ME/CFS.
Dr. Leorey Saligan
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[/fright]Dr. Saligan is another kind of in-between figure. Saligan is exploring the "biobehavioral" aspects of cancer fatigue. He's recently found that the increased oxidative stress in red blood cells, mitochondrial issues, and the upregulation of neuroinflammatory factors contributed to fatigue in cancer. He's done numerous studies on gene expression and mitochondrial dysfunction in cancer.
With regards to post-cancer fatigue he's mostly focused on exploring the effects of HPA axis and sympathetic nervous system dysfunction on fatigue. Saligan also did a review paper on catastrophizing and cancer fatigue, and is interested in the effects of pain, sleep, depression and catastrophizing as well. It's not his main focus but he's clearly interested in that area.
Saligan has been the principal investigator of four Clinical Center studies:
Brian Walitt has been covered before but suffice it to say that his idea that ME/CFS is a psychosomatic disorder is incredibly off-putting and the reaction to him being involved in the study is understandable.
Even Walitt, however, is not such a black/white figure. He does not believe that CBT or exercise (or drugs) are particularly helpful in fibromyalgia, and his research focus is mostly physiologically oriented. In a head-twister, he apparently wants to prove that ME/CFS and FM are physiologically based psychosomatic disorders.
Elizabeth Unger
Elizabeth Unger has done only physiological research since she took over the CDC's ME/CFS program. She has published studies on NK cell functioning, reduced telomere length, inflammatory gene expression and gynecological risk factors and has made studying ME/CFS experts and their patients a central focus. She has also archived the Toolkit and had moved CBT/GET to the management section of the document.
There's no indication that she believes ME/CFS is a psychological or behavioral disorder but Elizabeth Unger did not pass the CBT/GET litmus when she reportedly told a patient that there is scientific evidence for it - (there are dozens of studies on it after all) - so the petitioners asked that she be removed from the study.
The Committee Members
Things don't appear to be as simple in the U.S. as in the U.K. Every researcher and doctor that was linked to some sort of behavioral activity in this petition also has a strong background of physiological research.
These are not, therefore, Peter White or Simon Wessely-like figures. In fact, so far as I can tell, there are no Peter White or Wessely-like figures in positions of power in the U.S.. (Peter Manu is the last pure Wessely-like figure of note in the U.S. that I can think of, and he disappeared about 15 years ago.) The U.S. does do some behavioral research in ME/CFS, but it does much, much more physiological research, and it has for as long as I can remember.
It may be that in the past that a belief that CBT/GET may help often did indicate that a researcher or doctor had some psychological agenda but I suggest the possibility that it does not necessarily mean that today. Dozens have studies, perhaps many of them flawed, have been done on these subjects.
The more important question for me with regards to this study is what are the researchers main focus? A researcher focused on CBT/GET doesn't belong in this study and none of them are.
A Psychiatric Study
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[/fright]The petition presents the study as an attempt to define ME/CFS as a psychiatric disorder. (A passage in original form of the petition - which was changed after about 1,800 people had signed it - proposed that the study would return ME/CFS research to the dark ages.)
It's clear in the "reasons for signing the petition" that's the idea the petition got across:
That's unfortunate because it deprives people with a devastating chronic illness of a legitimate source of hope.
Other Issues
In some places the petition is not accurate.
The NIH is currently funding somewhere around 10 extramural studies on ME/CFS and has been funding extramural studies (not very of them for sure) for decades. (To be more accurate, this is the first intramural study on ME/CFS done in the NIH's Clinical Center hospital.)
Two Day Exercise Tests Required For Entry
The petitioners propose that the participants do a two-day exercise test before they enter the study. Who would be willing or able, though, to tolerate two two-day exercise tests? Some people would but I imagine that most would not. A bigger question is why such a harsh requirement is necessary for a study already being filled by ME/CFS practitioners?
Another question would be whether we would even want such restrictive guidelines? Would it be better if the study results referenced the subset of ME/CFS patients who failed the two-day exercise test or if reflected short duration, infectious onset patients who meet the CCC criteria?
No Psychiatric Conditions Be Considered
If this refers to patients entering the study, then the patients will all be coming from ME/CFS experts. If it refers to psychiatric questionnaires they're a standard part of any large study. Aside from those questionnaires there are no psychiatric components in this study.
Replace Executive Committee with ME/CFS Experts (Leonard Jason, Dan Peterson, Sue Levine, Nancy Klimas, and José Montoya.)
It's a nice idea, but if the role of the Executive Committee is largely confined to checking the patients in, etc. it's simply not feasible to have outside experts be present. It's also possible that the Committee members have to come from within the Intramural Center.
It's not clear exactly what the Committee is going to do. If these ME/CFS experts can be involved, of course, it would be preferable for them to be involved.
Conclusion
The figure putting together this study - Dr. Avindra Nath - is a neuroinfectious disease specialist who has put together, not surprisingly, a study that reflects his interests. He's stated he has no background in psychiatry and no interest in it and the study reflects that.
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[/fright]My conclusion is that while the intentions behind the petition were laudable that it does not help. While it certainly presents an area of concern - the presence of people who believe in CBT/GET, etc. in an important study - it ignores facts suggesting that these individuals feel ME/CFS is a real, serious physiological disorder.
From a pragmatic or strategic standpoint the petition is a failure; it has the potential to antagonize but not to effect change. After a major attempt to remove Brian Walitt failed it became clear that the NIH isn't going to budge on members with less severe problems. (There's certainly no way the NIH was ever going to remove someone like Elizabeth Unger from this study.)
The petition does reflect the belief held by many that no one who has said anything positive about CBT/GET should be allowed within ten miles of this and other studies. That's understandable but litmus tests like that may be difficult to achieve at an institution like the NIH.
The key question for me in any study is the focus of the study. If the study is focused on pathophysiology and the researchers main focus is physiology then I'm not particularly bothered by other issues. If this study had CBT/GET components, if it was focused on measuring psychiatric factors, if it had anything other than physiological elements in it that would be worth fighting for. I recognize that I'm different in that way.
In part, for better or worse, we are in the process of building relationships and gathering a community of researchers to study ME/CFS. Dr. Nath has referred to some push-back from NIH researchers who were apparently miffed by efforts to remove their colleagues. We'll never know exactly why they felt that way, but it does indicate that some researchers take attempts to knock their colleagues out of a study quite seriously.
That outcome (which no one expected) suggests that attempts to remove people from studies should be done judiciously, and only when really necessary; i.e. only when a person's ideas are so damaging and that person has such an ability to do damage, that it's worth antagonizing some people to get him/her out.
I also propose the possibility that while a belief in CBT/GET may have once been a huge red flag, and may still be a red flag, that it doesn't necessarily mean that that person believes this disease is not real or physiologically based. I believe we should put the person's history into context; i.e. determine what their main focus is - before we take action. In some cases, it might be better to just live with having some individuals in some studies.
The petition's failure to put the Committee membership into context of the whole study (it appears to play a small part in it) was, in my opinion, unfortunate. It has lead some people to have an unnecessarily dark view of a study that has the promise to move forward ME/CFS substantially.
[fright]
The petition begins by indirectly asserting that the study creators don't recognize or are willing to use the existing biomedical research into this illness to inform the study.
P2P Mismatch?
The petition also states the study doesn't fit the P2P guidelines:
Much of the study design, however, could have come straight out of the report. In fact, in many places Dr. Nath's study goes considerably further than the P2P report proposed. The P2P report recommended that:
The Nath study:
- is doing the most comprehensive molecular profiling of immune cells ever done to date
- includes several brain imaging projects
- is measuring energy consumption in a metabolic chamber
- is growing ME/CFS neurons using stem cell technology and testing them
- is doing extensive autonomic nervous system testing
- is transplanting the immune systems of ME/CFS patients into mice
- is doing extensive viral testing
- is analyzing the gut and saliva microbiome
- is doing two-day exercise tests to assess the effects of exercise
The petition focuses on the membership of the "executive committee". It's not exactly clear what the executive committee will be doing - that is something of an area of concern. At this point they seem to be assessing whether the patients in the study meet the simple criteria for the study (infectious onset, meet the CCC, early duration patients) and giving them some initial questionnaires.
The makeup of the executive committee is not ideal but consider that the NIH was probably picking from a relatively small pool of doctors and researcher who were associated with the Clinical Center and could be on site to assess the patients.
The petition highlighted strikes against each of the members of the Executive Committee (except for Dr. Lipkin). While I understand the angst over having anyone that supports CBT/GET in the study, I question what that means.
- If a doctor or researcher says something positive about CBT does that mean that the doctor thinks the disease is psychological?
- If a doctor or researcher has included behavioral research in his portofolio, does that mean they cannot be trusted?
Dr. Gill
In a 2011 NIH presentation Dr. Gill associated ME/CFS with neurasthenia (is that inaccurate?), cited findings which did not show evidence of viral infections or orthostatic intolerance, and of stating that CBT is helpful. He suggested the positive test results from unproven tests (such as viral tests) were likely to be false positive, then cites several pages of unproven treatments and ends stating that CBT/GET are the only therapies shown to provide meaningful benefit.
[fright]
He advised that physicians emphasize that ME/CFS is a real illness, that it is not malingering and that it can be completely incapacitating. They should inform the patient that even though they do not know the cause of ME/CFS (or as he repeated mispelled it CSF) have good treatments for it that they can help.
There are several things in there that might really tweak one. The key question is whether the fact that a doctor supports behavioral treatments means that he believes ME/CFS is a behavioral disorder? Or could it mean that he/she's just a conservative physician?
Gill states that ME/CFS is not depression, that it is a real illness and that the medical profession simply doesn't know the cause or have good treatments for it.
A look at Dr. Gill's background suggests that psychiatry might be the last thing on his mind. Dr. Gill is an internal medicine and infectious disease specialist and his publications focus almost exclusively on the immune system.
I leave open the possibility that Dr. Gill believes CBT/GET helps, and that that belief in no way conflicts with his idea that ME/CFS is also a real and serious, physiologically based disorder. At the end of the presentation he proposed that neuro-endocrine-immune and immune gene expression studies under way might provide clues to ME/CFS.
Dr. Leorey Saligan
[fright]
With regards to post-cancer fatigue he's mostly focused on exploring the effects of HPA axis and sympathetic nervous system dysfunction on fatigue. Saligan also did a review paper on catastrophizing and cancer fatigue, and is interested in the effects of pain, sleep, depression and catastrophizing as well. It's not his main focus but he's clearly interested in that area.
Saligan has been the principal investigator of four Clinical Center studies:
- Investigating Molecular-Genetic Correlates of Fatigue Experienced by Cancer Patients Receiving Treatment (11-NR-0014)
- Molecular-Genetic Correlates of Fatigue in Cancer Patients Receiving Localized External Beam Radiation Therapy (09-NR-0088)
- Fatigue in Healthy Individuals (09-NR-0131), and
- Evaluation and Diagnosis of Potential Research Subjects with Pain and Fatigue Syndromes (08-NR-0132).
Brian Walitt has been covered before but suffice it to say that his idea that ME/CFS is a psychosomatic disorder is incredibly off-putting and the reaction to him being involved in the study is understandable.
Even Walitt, however, is not such a black/white figure. He does not believe that CBT or exercise (or drugs) are particularly helpful in fibromyalgia, and his research focus is mostly physiologically oriented. In a head-twister, he apparently wants to prove that ME/CFS and FM are physiologically based psychosomatic disorders.
Elizabeth Unger
Elizabeth Unger has done only physiological research since she took over the CDC's ME/CFS program. She has published studies on NK cell functioning, reduced telomere length, inflammatory gene expression and gynecological risk factors and has made studying ME/CFS experts and their patients a central focus. She has also archived the Toolkit and had moved CBT/GET to the management section of the document.
There's no indication that she believes ME/CFS is a psychological or behavioral disorder but Elizabeth Unger did not pass the CBT/GET litmus when she reportedly told a patient that there is scientific evidence for it - (there are dozens of studies on it after all) - so the petitioners asked that she be removed from the study.
The Committee Members
Things don't appear to be as simple in the U.S. as in the U.K. Every researcher and doctor that was linked to some sort of behavioral activity in this petition also has a strong background of physiological research.
These are not, therefore, Peter White or Simon Wessely-like figures. In fact, so far as I can tell, there are no Peter White or Wessely-like figures in positions of power in the U.S.. (Peter Manu is the last pure Wessely-like figure of note in the U.S. that I can think of, and he disappeared about 15 years ago.) The U.S. does do some behavioral research in ME/CFS, but it does much, much more physiological research, and it has for as long as I can remember.
It may be that in the past that a belief that CBT/GET may help often did indicate that a researcher or doctor had some psychological agenda but I suggest the possibility that it does not necessarily mean that today. Dozens have studies, perhaps many of them flawed, have been done on these subjects.
The more important question for me with regards to this study is what are the researchers main focus? A researcher focused on CBT/GET doesn't belong in this study and none of them are.
A Psychiatric Study
[fright]
It's clear in the "reasons for signing the petition" that's the idea the petition got across:
That's unfortunate because it deprives people with a devastating chronic illness of a legitimate source of hope.
Other Issues
In some places the petition is not accurate.
The NIH is currently funding somewhere around 10 extramural studies on ME/CFS and has been funding extramural studies (not very of them for sure) for decades. (To be more accurate, this is the first intramural study on ME/CFS done in the NIH's Clinical Center hospital.)
Two Day Exercise Tests Required For Entry
The petitioners propose that the participants do a two-day exercise test before they enter the study. Who would be willing or able, though, to tolerate two two-day exercise tests? Some people would but I imagine that most would not. A bigger question is why such a harsh requirement is necessary for a study already being filled by ME/CFS practitioners?
Another question would be whether we would even want such restrictive guidelines? Would it be better if the study results referenced the subset of ME/CFS patients who failed the two-day exercise test or if reflected short duration, infectious onset patients who meet the CCC criteria?
No Psychiatric Conditions Be Considered
If this refers to patients entering the study, then the patients will all be coming from ME/CFS experts. If it refers to psychiatric questionnaires they're a standard part of any large study. Aside from those questionnaires there are no psychiatric components in this study.
Replace Executive Committee with ME/CFS Experts (Leonard Jason, Dan Peterson, Sue Levine, Nancy Klimas, and José Montoya.)
It's a nice idea, but if the role of the Executive Committee is largely confined to checking the patients in, etc. it's simply not feasible to have outside experts be present. It's also possible that the Committee members have to come from within the Intramural Center.
It's not clear exactly what the Committee is going to do. If these ME/CFS experts can be involved, of course, it would be preferable for them to be involved.
Conclusion
The figure putting together this study - Dr. Avindra Nath - is a neuroinfectious disease specialist who has put together, not surprisingly, a study that reflects his interests. He's stated he has no background in psychiatry and no interest in it and the study reflects that.
[fright]
From a pragmatic or strategic standpoint the petition is a failure; it has the potential to antagonize but not to effect change. After a major attempt to remove Brian Walitt failed it became clear that the NIH isn't going to budge on members with less severe problems. (There's certainly no way the NIH was ever going to remove someone like Elizabeth Unger from this study.)
The petition does reflect the belief held by many that no one who has said anything positive about CBT/GET should be allowed within ten miles of this and other studies. That's understandable but litmus tests like that may be difficult to achieve at an institution like the NIH.
The key question for me in any study is the focus of the study. If the study is focused on pathophysiology and the researchers main focus is physiology then I'm not particularly bothered by other issues. If this study had CBT/GET components, if it was focused on measuring psychiatric factors, if it had anything other than physiological elements in it that would be worth fighting for. I recognize that I'm different in that way.
In part, for better or worse, we are in the process of building relationships and gathering a community of researchers to study ME/CFS. Dr. Nath has referred to some push-back from NIH researchers who were apparently miffed by efforts to remove their colleagues. We'll never know exactly why they felt that way, but it does indicate that some researchers take attempts to knock their colleagues out of a study quite seriously.
That outcome (which no one expected) suggests that attempts to remove people from studies should be done judiciously, and only when really necessary; i.e. only when a person's ideas are so damaging and that person has such an ability to do damage, that it's worth antagonizing some people to get him/her out.
I also propose the possibility that while a belief in CBT/GET may have once been a huge red flag, and may still be a red flag, that it doesn't necessarily mean that that person believes this disease is not real or physiologically based. I believe we should put the person's history into context; i.e. determine what their main focus is - before we take action. In some cases, it might be better to just live with having some individuals in some studies.
The petition's failure to put the Committee membership into context of the whole study (it appears to play a small part in it) was, in my opinion, unfortunate. It has lead some people to have an unnecessarily dark view of a study that has the promise to move forward ME/CFS substantially.
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Other people - probably not many, for sure - might believe, though, that the NIH has never done an ME/CFS study until now.
