USA: National Institutes of Health (NIH) intramural ME/CFS study

I would do it if I could (the reimbursement would almost cover flights to the USA), but I've probably had this for 18 years.

 

Yes, it's a shame there can't be a <5yrs group and a >5yrs group. The illness looks so different over time, and I think that's one (of many) reason(s) we're having trouble with the diagnostic criteria. It would be so interesting to compare the data from oldies and newbies.

 

I would totally volunteer but I've been ill over ten years, so don't qualify. Since it often takes folks so long to even be diagnosed, it may be tricky finding those who have been sick the right length of time and know what they have. When I first was ill, the docs kept saying, "sometimes it takes a few months to get over a bad virus." When I came back in six months they said, "We often see it taking about a year to get over mono especially in adults." When I came back in a year they said, "Lots of post-viral illnesses improve after two years." After two years of severe illness, I went back again and they said, "You're probably depressed and don't know it." (i wasn't). So it took a long time before I was given a diagnosis.

 

I get the reason why (the illness is supposed to change after two or three years), so I can't complain. But it'd be nice to know about the veterans too.

 

Have they done any vision tests? Vision and balance are fairly intertwined. In a neurological workup I'm pretty sure they would have checked for nystagmus, but it's a simple test you could easily have not noticed. There's another simple test done in an eye exam where they cover and quickly uncover each eye. It's a check for latent strabismus, a problem in which the eyes don't always converge on the exact same spot. I think it too can be related to the inner ear and balance. The Romberg test simply sees if you can maintain your balance while standing with your eyes closed. None of these might seem like balance tests, unlike, say, other tests where you sit in a spinning chair, or have a little water pumped into the ear canal.

 

@B_V

Thank you for posting the list of the scientists who are involved. I seem to remember some controversy relating to Dr Walitt's view of ME as a non biological illness. He is listed as lead clinical investigator.
A quick look at ME pedia refers to a fairly recent article, 2015, with Dr Walitt as a co-author of an article referring to cfs as a somatoform disorder. Is this still his view, and if so, how is this going to play out?

http://me-pedia.org/wiki/Brian_Walitt#Controversy

 

Since Dr Walitt’s contact information was listed, do you feel that asking him your questions directly may be the best approach?


Edited to add contact info:

Brian Walitt, lead clinical investigator:
Building 10, Room 2-1341
10 Center Drive
Bethesda, MD 20892
301-827-0117
brian.walitt@nih.gov

 

I can't and don't speak for him but he's helping out on the deepest biological investigation of ME ever performed. He added skin and muscle biopsies and natural killer cell studies and spinal fluid pathogen studies to the protocol recently. The PI, Avi Nath, has final say over data interpretation. The NIH answered questions about him back when his involvement in the study was announced. I suggest you take a look at the FAQ in the first post of this thread.

 

Great to hear about your experience at the NIH. In my case doctors have in the past few months realized that my ME/CFS was a mis-diagnosis and that I actually have a rare autoimmune disease called Relapsing Polychondritis (RP).

The NIH facility in Bethesda, Maryland has an ongoing RP study in which they invite RP patients to travel there and stay for some days to undergo various studies and tests. One of the NIH doctors heading up the study actually has RP herself. The RP study doesn't offer any financial reimbursement though like the ME/CFS study so I'd have to pay for the cross-country travel expenses myself. Perhaps I can do a fundraiser?

I'm feeling inspired by reading about your experience and I am going to start the process of having my medical records sent to the NIH. They take just about every RP patient due to the rareness of the disease, but I expect it will probably be at least a year until it will be "my turn".

Did you stay at the NIH lodge? If so was a loved one able to stay there with you?

 

Yes, on this trip I went with someone and she stayed at the Safra Family Lodge on campus. It's right across from the Clinical Center, so it's very convenient. I spent weekends at the lodge and the weekdays overnight in the Clinical Center. The lodge is really lovely - only about 12 years old, with endless hot cocoa and a warm fire. The Friends of NIH (non-profit that Francis Collins's wife helps run) brings in home-cooked dinners every Sunday. The back story of the guy whose fortune built the place is pretty crazy too. He was a Brazilian-Lebanese-Israeli international man of mystery who had been a patient at the neurological institute. He died in a suspicious fire in Monaco. Look up a Vanity Fair article from the year 2000 if you're interested in some crazy stuff. (Which has nothing to do with the lodge itself.) Good luck. Some on-campus studies provide travel funds for patients, some don't. The ME study does. https://clinicalcenter.nih.gov/familylodge/

One other thing about the intramural NIH ME study: Not only is it the deepest biological study of ME ever done (I'm convinced), I've repeatedly had various NIH people tell me the study may be unique in the history of the entire NIH. Most studies done on campus are testing a hypothesis or two. No one I've talked to, including people with decades of experience working there, can recall an exploratory study this broad and this deep diving into a relatively open-ended search for the biological mechanisms of a disease. There are about 40 sub-studies. Avi Nath does have a hypothesis about immune dysfunction that he is testing, but many other avenues are being explored. The investigators have authority from Dr. Collins to do pretty much anything they want to do and they've recruited help from many different NIH institutes. I've been impressed watching the study evolve and seeing the key people learn as they go.

As for Dr. Walitt, I like him and had conversations with him every day. He was responsive and attentive and he's a good listener. Whenever I had an issue - like a nurse wearing heavy perfume (ick) - he promptly took care of it. He was constantly looking for feedback on the study design and the many procedures that I went through. I have gathered from other study patients that he delivers the same level of attention to anyone coming through.

 

Exciting and hopeful!

Very reassuring!

Thank you so much for talking about your experience there, Brian, it's so helpful and also so nice to get a 'peek' inside.

 

Is there a time frame when we can start to see the first results? It seems everythig pretty good but it goes terribly slowly. Will they release some part results?

 

The first paper out will probably be from the researcher who led the focus groups on PEM. Twenty patients participated in a total of four phone calls, and those discussions helped guide the design of the second visit of the study (which is explicitly studying PEM after an exercise challenge). She said she's finishing up that paper. As for most of the results, they won't come until all of the volunteers finish their visits. Spinal fluid, for instance, is being pooled. The pools - one from patients, the others from the two control groups - will then be examined for thousands of immune system proteins and compared. That work can't be done until the researchers get spinal fluid from everyone. There are other substudies that also need to wait for everyone to come through.

So far 16 patients have completed visit 1, and I was the second patient to complete visit 2. About the same number of controls have come through. As I posted on Phoenix Rising, myself and others have talked to the study team about ways they can speed things up. They tried running a healthy volunteer and a patient through the protocol simultaneously. It sounds like things got a little hairy, but I think they will try that again. That's the most obvious way to speed up the study.

Running two patients at the same time is not feasible, I was told. Patients need a lot of attention and the team is fairly small - two nurses, two post-bachelor's fellows (who are really helpful - they squire patients around the huge building and collect samples, etc. etc.), a patient coordinator and Dr. Walitt. That's the ME team. Avi Nath does a neuro exam on patients during visit 1 and makes decisions about the protocol when issues arise. Dozens of other physicians and researchers are involved for their expertise, such as the person who does the neurocognitive testing. The protocol uses all kinds of resources around the Clinical Center - the patient rooms, MRI machines, a surgeon to do the muscle biopsy, transcranial magnetic stimulation machines, lumbar puncture under fluoroscope (for some of us, others get a bedside LP), the exercise test room, the metabolic chamber for 5 nights. Coordinating all of that is a big task and those resources are finite and are being used by hundreds of other studies.

I asked about adding more people to the team, but after a discussion about it, I don't think that would speed things up all that much. Each patient spends a total of nearly 4 weeks at the Clinical Center - two weeks for visit 1 and another two for visit 2. Healthy volunteers complete the protocol in about 3 weeks. There are so many tests and procedures being run that those times can't really be compressed. Visit 2, especially, cannot be shortened because PEM is being studied out to 72 hours after the exercise test. And the patient spends week 1 doing pre-exercise tests. Adding staff - say another nurse - will probably lead to a lot of downtime for that person, and idle government workers tend to be a problem. I do hope they try again to run a healthy person and patient through simultaneously to speed it up.

At this rate, I think it will be about three more years before the study is finished. That's a long time. I'm not happy about it, but I understand the trade-offs at play. In-depth = time-intensive. The NIH could have spent a week with each patient, not studied PEM, done a few basic sub-studies, and called it a protocol. Instead, we will have a very comprehensive look at ME from many different angles. I think that the results will be really valuable, but unfortunately it's going to take a while.

 

In the interest of transparency, here's my schedule from the recently completed second visit. A few items were added later (like an echocardiogram), but this reflects most of what the visit entailed.

 

Thanks for all your information on this, @B_V. This is a hugely important study and I'm glad to hear the detail of how it's proceeding. It sounds very impressive indeed.

If recruitment is a major roadblock, would it be worth writing something that could be put out widely via Solve, #MEAction, etc. etc.?

 

Can you volunteer who that researcher is, and whether that paper will be available for non-participants to see - and if so, when?

Do you have any insight into which results you are privy to on an individual subject basis vs. which results are only pooled results and are not individually broken out for you to see?

 

@B_V

Firstly, Thanks again for the detail you have produced re this study, tests etc. It gives more understanding of how this type of research is conducted, what tests are needed etc and the global nature of the whole process. In 1986, I had a spinal tap about 4 months into the viral infection which I think is at the root of my illness. I was not given specific results and the infection began to clear; no doubt the results have disappeared but I will check.

Secondly, In considering why there has been so little follow up by patients prepared to participate, is it possible that there exists a groundswell amongst patients not to get involved because there is concern about Dr Wallit's previously expressed views, whether justified or not?

http://me-pedia.org/wiki/Brian_Walitt#Controversy

When I read further down this page, there was reference to a 2016 article which led on to a discussion on Cort's ' Health Rising'. There were many pages of comments by responders who wanted nothing to do with the project because of their perceptions of Dr Walitt. ( I am trying to be careful how I express this - the emphasis is on perceptions: bold not working).

https://thoughtsaboutme.com/2016/02...e-perception-mecfs-as-normal-life-experience/

Again there are many, many adverse comments on working with Dr Walitt.
I have not investigated the narratives of illness that he was said to describe but perceptions of his work may surely affect whether patients wish to be involved.
For patients already involved like yourself, I imagine there is real worry about the recruitment of patients. You have already given a lot emotionally and physically. Is there a time limit on the collection of samples for comparison purposes? What happens if more patients are not recruited pretty quickly?

As others have said, this research asks a lot. Honestly, after an experience of severe deterioration following an exercise test, I would not wish to engage with so much exercise. Not that I am eligible: ill for far too long.

Just wondering actually, when a research trial is planned, how much attention is given to how feasible it is in terms of demands on patients?

There's a fair bit to cover there but thank you for engaging with the forum. I would be interested to hear your views.

 

It seems unlikely someone would express a strong negative opinion on the internet, then call into NIH to express interest in volunteering, make it through a screening interview, and then decide not to participate based on previously stated strong negative opinion. Plenty of people have contacted the NIH team expressing interest. It's somewhere between 200 and 300. The problem lies after people make it through the initial screening and are re-contacted by the NIH team with news that they may eligible to participate. That's where the very high attrition rate takes place. If just 10% or so of the people who are re-contacted joined the study, the study would be full. It only needs another 20-25 patients.

That said, Angelique told me she has gotten a bump in the number of calls and emails from patients expressing interest lately, so thank you Tom Kindlon and anyone else who has helped spread word. It's working.

 

@B_V

I am not suggesting that someone who felt strongly enough to criticise the study online would then express an interest in volunteering, then decide not to participate.

I do believe that someone who expressed an interest might then investigate further and perhaps not like what they see. There were many criticisms in the US of the study's design and protocol. That might explain the attrition rate between expression of interest and not continuing.

https://www.meadvocacy.org/nih_sidesteps_critical_problems_with_the_me_cfs_study

I do remember concerns about the NIH study from a couple of years back and have seen that many members of the US ME community were very critical of it. In fact they called it #Paceonspeed if I remember correctly. Well as a UK pwme, when we are trying so hard to get rid of Pace and beginning to turn the tide, that concerns me.

A big worry of mine is the amount of exercise required to participate. I think the study itself acknowledges that it is not suitable for severe patients. But if they are only investigating people with mild/ moderate ME, will the uninformed generalise it to all patients with ME. Advocates have expressed other worries. See link above.

I have attached the link with further comments on the study. I think @Keela Too commented but I think she is not online at the moment.

Glad that you are here to bring notice of this study to the UK. If it is #Paceonspeed, then we need to know.

EDIT: link moved