Brian Vastag
Six year ago, I returned to NIH, where I started my career as a science writer, to be a patient in an amibitous study to understand post-infectious myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).
The study included 30+ researchers & substudies & was a fishing expedition to understand what goes wrong to make us so sick (like bedbound-for-years sick).
NEWS: The study's findings have FINALLY been submitted for publication.
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Brian Vastag
A 2015 Institute of Medicine report had reaffirmed that ME/CFS was a biological, not psychological, disorder, and there had been other pressures on Collins to act. So he moved responsbility for ME/CFS out of the small and under-funded Office of Women's Health over to the National Institute of Neurological Disorders and Stroke, a more appropriate home.
IOM report: https://pubmed.ncbi.nlm.nih.gov/25695122/
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Brian Vastag
Collins, to his credit, emailed me and said he would move fast. This was in 2015. And he kept his word. He gathered some top clinicians at NIH and told them to design an intramural study - meaning it would take place on the NIH campus in Bethesda, Md. - to try to figure out what goes so wrong in the disease. Collins chose neurovirologist Avindra Nath (pictured with me above) to be priniciple investigator. Nath is the head of clinical neurology at the NIH Clinical Center.
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Brian Vastag
The study began after I wrote to then-NIH Director Francis Collins, whom I had talked to in my job as a science reporter at the Washington Post, imploring him to invest in understanding ME/CFS, which has been neglected for decades. I also knew other top administrators at NIH and so decided to use my connections to try to get some movement.
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Dr. Dan Killam
@brianvastag @Bether I never would have considered that this disease could be under-researched because sufferers literally physically lack the ability to sign up and participate in studies. that is wild.
Brian Vastag
Visit two was exhausting. I talked with other patients in the study who were sicker than I was, and they were absolutely annihilated by it. Some took months to recover back to their already-shitty baseline functioning. It was an ordeal, but we were all motivated to help move research forward. 12/
Brian Vastag
I also spent 4 nights inside a sealed metabolic chamber. Every calorie in and out is measured (I'll spare you the scatalogical details). The chamber measures how much CO2 a person exhales, and these numbers together can measure metabolic rate. The chamber was loud - lots of fans - and I didn't get much sleep. Here's my arm sticking out of the chamber for blood work, with my friend Andreas filming for German television. 11/
Brian Vastag
In March of 2018, I returned to Bethesda for the second visit, having been unanimously judged to, in fact, be suffering from ME/CFS. During this visit - another 10 days inpatient - I took a cardio-pulmonary exercise test, which produces very abnormal results in ME/CFS. Exertion makes us sicker, and this test shows that objectively. 10/
Brian Vastag
The study was unique in that after the extensive work-up in visit 1, five outside ME/CFS expert clinicians reviewed each case to decide if the patient fit all the published criteria for ME/CFS. This was quality control, to ensure patients really had ME/CFS. Three patients of the initial group were found to have other diagnoses - one had Parkinsonism, one had a rare (and fatal cancer), and so they were excluded from the second phase of the study. 9/
Brian Vastag
Patient advocates implored Nath to speed up the study by, for instance, bringing in two patients simultaneously. Or to bring in a patient and a healthy volunteer together. They tried this but decided they didn't have the staff bandwidth to do it. Nath and Walitt both had many other responsibilities & studies to attend to. As a senior NIH official told me about this whole thing: Everyone at NIH has a full plate. They have to push some stuff to the side to make room for new things. 8/
Brian Vastag
Patient recruitment was slow; the aim was 40 patients in the first phase, which would be winnowed down to 20 for a second visit to NIH a year after the first. I'm not sure why recruitment was so slow. There was skepticism in the patient community due to NIH's longtime neglect and dismissal of the illness. 7/
Brian Vastag
I was patient #4 when I arrived in April 2017. The study was grueling. I wore an ECG cap for a sleep study (I didn't get much sleep); had a difficult spinal tap; donated 10 million blood stem cells; had 29 vials of blood taken in one go (fun morning!); took extensive cognitive exams; spent three hours relating my entire health history to the lead clinician in the study (Brian Walitt); and on and on. I stayed as an inpatient for two weeks, with a weekend off. 6/
Brian Vastag
While the protocol for the study was designed and approved in a month - very fast for NIH - it took almost a year to stand up the study, hire some support staff, and begin recruiting patients and healthy volunteers as controls. You can see the study details below. 5/
Brian Vastag
And finally, a few days ago - six years to the week I first entered the study - I got word that the NIH, after extensive internal review, has FINALLY submitted their main paper from the study to a journal for publication. I suspect Avi submitted to New England Journal of Medicine, his go-to journal, but I don't know for sure. It took entirely too long. 17/
Brian Vastag
Eventually, the NIH team formed 5 data analysis groups for the study. One for immunology, another for physiology, etc. There is so much data in this study of a small group of patients. I think the study was very ambitious, and the team was under-resourced. While 30 or so researchers were involved, most were just pitching in on very specific sub-studies. It was up to Avi and Brian to try to synthesize everything. 16/
Brian Vastag
The ME/CFS study was very much back-burnered. The pandemic was taking everyone's attention. I talked to Brian Walitt later and asked him why the team didn't spend the time when the Clinical Center was mostly closed to analyze the very voluminous data. I didn't get much of a satisfactory answer, but as Nath was the PI, he was diverted to covid, and that probably is the answer. 15/
Brian Vastag
Then the #covid19 pandemic hit and the clinical center closed down. The team was unable to complete full study enrollment, a few patients short. Avi Nath turned his attention to autopsy studies of early covid victims to look for signs of brain damage and viral infilitration. In early 2021, the NIH team also brought in about 10 people who developed ME/CFS-like symptoms after covid vaccination, treating some with immunoglobulin & steroids. 14/
Brian Vastag
From early 2017 through early 2020, the under-resourced team managed to bring in something like 18 patients for two visits, and I think they hit their target on healthy volunteers. Like we all told them, it was way too slow. But it was moving forward. 13/
Brian Vastag
#LongCovid is, in many cases, ME/CFS. In May 2020, @Bether and I warned that this would happen in pages of the Washington Post. The article was extremely well-read - it was on the homepage for over 24 hours, a rarity - but it also hit the same weekend the George Floyd protests started. If not for the protests, I'm quite certain we would've gotten good TV and radio pick-up (broadcast people look at the top articles on WaPo and NYT and follow those stories). 19/
Brian Vastag
And I have no idea what they've found, or how valuable it will be. They threw so many technologies at this illness they must've found something interesting. They used a technology to look at thousands of proteins in spinal fluid, for instance. In the meantime, millions more people have developed ME/CFS after covid - an outcome obvious to all of us who have been suffering post-infectious ME/CFS pre-pandemic. 18/
NilaJones
Just this one line
I have enough experience to read between the lines, and I am filled with rage and grief for that patient who had been misdiagnosed, and now is going to die
I know how many doctors they probably saw, who told them nothing was wrong with them -- until one finally said you have chronic fatigue go home
And that wasn't right either
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