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NIH to focus its ‘world-class’ technology and expertise on ME/CFS | #MEAction
My new blog at MEAction based on Dr Avindra Nath's Solve ME/CFS initiative webinar hosted by Zaher Nahle
The phrase that stood out in Dr Avindra Nath’s description of the NIH ME/CFS study was ‘world-class’. He emphasized the innovative technology the NIH has at its disposal, and its distinguished experts on just about every subject that’s relevant to ME/CFS. Nath mapped out how the study will bring some serious firepower to the study of ME/CFS, particularly to get a better understanding of what’s really going on in the immune system.
Nath also expressed concern that the ongoing level of criticism of the study from patients is putting off good biomedical researchers lending their expertise to the study.
Late last year, Director Dr Francis Collins assembled a team of experts, including Nath, to discuss what the NIH could do to study ME/CFS. The discussion soon focused on the role of the immune system and Collins asked Nath to lead an in-house (intramural) study.
Nath’s credentials make him very well placed to study ME/CFS, with expertise in immunology, viruses, and the brain, but he’s also a clinician: a rare combination of skills in his field of neuroimmunology and infectious diseases. Nath has seen many ME/CFS patients himself, and added that his role running a multiple sclerosis clinic might be relevant as well. Fatigue is often the most disabling symptom in multiple sclerosis, and many patients respond to immunomodulatory drugs. Nath has already said that if they can identify immune problems in ME/CFS, the final phase of this study would be to test if immunomodulatory drugs can improve the health of ME/CFS patients.
Nath’s hypothesis is that, for a substantial subgroup, ME/CFS is triggered by a viral illness that results in immune-mediated brain dysfunction. As he explains, “that brings in our expertise: we have the virology, we have the immunology, and we have the neuroscience.” The study focuses on patients who had an infectious onset, which could be bacterial as well as viral.
NIH study aims to find new avenues to explore…
According to Nath, there are basically two ways to run a well-designed study: you can do a few things to a lot of patients, or you can take a few patients and run a wide variety of tests.
The NIH intramural program excels at doing a really deep study of a few patients, he said, while outside research groups were very good at focusing on a relatively few things in a very large group of patients.
The NIH is uniquely well-placed to do a small, exceptionally intense study of patients because of its leading-edge technology and breadth of world-class researchers. It is the researchers’ hope that the study will generate new findings that outside researchers can then explore in larger, more focused studies. That, of course, is a case where RFAs and NIH grants will come in.
Three-stage study
This “study” is actually a series of three. Phase one, the focus of Nath’s talk, is the deep, deep study of patients that aims to clearly identify abnormalities and biomarkers – ideally, those that play a role in driving the disease rather than simply being markers of it. Phase two aims to check that these findings hold up in a cohort of patients tracked over time. The final phase aims to target those abnormalities with drugs, to see if changing those factors will impact the illness.
Assessing patients, probing fatigue
Phase one of the study starts with a detailed clinical profile of every patient: this includes the usual in-depth history, physical, psychiatric, infectious disease and neurological assessments, and the less common endocrine function, autonomic function, exercise capacity and fatigue testing.
Measuring function both before and after exercise is a core part of the design.
Next, the researchers will systematically probe the physiology of fatigue by measuring function of brain and body both before and after exercise. That’s a core part of the design, and never before has a study taken such a comprehensive look at the impact of exercise on patient’s biology and functioning....
....
Dr Avindra Nath’s expertise in neuroimmunology and infectious diseases is a good fit for ME/CFS. That the NIH have him working on Ebola and Zika indicate he’s highly-rated; and his publication record is deeply impressive. The study pursues a hypothesis many researchers share: that an initial infection triggers abnormalities in the brain and immune system leading to the symptoms of ME/CFS. Nath’s study brings many new techniques to ME/CFS, will bring in top-notch researchers, takes a comprehensive approach from metabolism to immunology to cell culture, and is built around studying the impact of exercise on patients. There is good reason to hope that the NIH, with its unique resources and approach, will find something new and important that will dramatically advance our understanding of ME/CFS.
Read the full blog
My new blog at MEAction based on Dr Avindra Nath's Solve ME/CFS initiative webinar hosted by Zaher Nahle
The phrase that stood out in Dr Avindra Nath’s description of the NIH ME/CFS study was ‘world-class’. He emphasized the innovative technology the NIH has at its disposal, and its distinguished experts on just about every subject that’s relevant to ME/CFS. Nath mapped out how the study will bring some serious firepower to the study of ME/CFS, particularly to get a better understanding of what’s really going on in the immune system.
Nath also expressed concern that the ongoing level of criticism of the study from patients is putting off good biomedical researchers lending their expertise to the study.
Late last year, Director Dr Francis Collins assembled a team of experts, including Nath, to discuss what the NIH could do to study ME/CFS. The discussion soon focused on the role of the immune system and Collins asked Nath to lead an in-house (intramural) study.
Nath’s credentials make him very well placed to study ME/CFS, with expertise in immunology, viruses, and the brain, but he’s also a clinician: a rare combination of skills in his field of neuroimmunology and infectious diseases. Nath has seen many ME/CFS patients himself, and added that his role running a multiple sclerosis clinic might be relevant as well. Fatigue is often the most disabling symptom in multiple sclerosis, and many patients respond to immunomodulatory drugs. Nath has already said that if they can identify immune problems in ME/CFS, the final phase of this study would be to test if immunomodulatory drugs can improve the health of ME/CFS patients.
Nath’s hypothesis is that, for a substantial subgroup, ME/CFS is triggered by a viral illness that results in immune-mediated brain dysfunction. As he explains, “that brings in our expertise: we have the virology, we have the immunology, and we have the neuroscience.” The study focuses on patients who had an infectious onset, which could be bacterial as well as viral.
NIH study aims to find new avenues to explore…
According to Nath, there are basically two ways to run a well-designed study: you can do a few things to a lot of patients, or you can take a few patients and run a wide variety of tests.
The NIH intramural program excels at doing a really deep study of a few patients, he said, while outside research groups were very good at focusing on a relatively few things in a very large group of patients.
The NIH is uniquely well-placed to do a small, exceptionally intense study of patients because of its leading-edge technology and breadth of world-class researchers. It is the researchers’ hope that the study will generate new findings that outside researchers can then explore in larger, more focused studies. That, of course, is a case where RFAs and NIH grants will come in.
Three-stage study
This “study” is actually a series of three. Phase one, the focus of Nath’s talk, is the deep, deep study of patients that aims to clearly identify abnormalities and biomarkers – ideally, those that play a role in driving the disease rather than simply being markers of it. Phase two aims to check that these findings hold up in a cohort of patients tracked over time. The final phase aims to target those abnormalities with drugs, to see if changing those factors will impact the illness.
Assessing patients, probing fatigue
Phase one of the study starts with a detailed clinical profile of every patient: this includes the usual in-depth history, physical, psychiatric, infectious disease and neurological assessments, and the less common endocrine function, autonomic function, exercise capacity and fatigue testing.
Measuring function both before and after exercise is a core part of the design.
Next, the researchers will systematically probe the physiology of fatigue by measuring function of brain and body both before and after exercise. That’s a core part of the design, and never before has a study taken such a comprehensive look at the impact of exercise on patient’s biology and functioning....
....
Dr Avindra Nath’s expertise in neuroimmunology and infectious diseases is a good fit for ME/CFS. That the NIH have him working on Ebola and Zika indicate he’s highly-rated; and his publication record is deeply impressive. The study pursues a hypothesis many researchers share: that an initial infection triggers abnormalities in the brain and immune system leading to the symptoms of ME/CFS. Nath’s study brings many new techniques to ME/CFS, will bring in top-notch researchers, takes a comprehensive approach from metabolism to immunology to cell culture, and is built around studying the impact of exercise on patients. There is good reason to hope that the NIH, with its unique resources and approach, will find something new and important that will dramatically advance our understanding of ME/CFS.
Read the full blog
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