Quick NIH Updates

A few quick hit NIH updates, all drawn from the website for the Clinical Care study:

The consent form for the study has been posted. Of note, people with depression, anxiety, etc. are excluded if their symptoms are not well-controlled on medication. In addition, drugs that may make you ineligible may include pain and sleep medications, steroids, and biologic immune modifying agents. The consent form provides a description of all the testing involved in the study, including the exercise test.

The Workwell Foundation announced that NIH was conducting a focus group on post-exertional malaise. The consent form for that focus group is also available. NIH plans to conduct a small group discussion of patients’ experiences of post-exertional malaise to help them create a questionnaire for the study.

Dr. Avi Nath is leading an ME/CFS Special Interest Group at NIH. The website says, “The ME/CFS SIG seeks to provide a forum in which to disseminate and discuss clinical and scientific information about ME/CFS. It is open to all interested intramural and extramural investigators seeking to learn more about ME/CFS and hopes to foster new research collaborations across the NIH campus.” As Dr. Nath had promised, outside experts in ME/CFS are brought in to give talks to the research team. To date, those speakers have been Dr. Anthony Komaroff, Dr. Leonard Jason, Dr. Daniel Peterson, and Staci Stevens and Dr. Mark Van Ness.

This entry was posted in Advocacy, Research and tagged , , , , , , , , , . Bookmark the permalink.

18 Responses to Quick NIH Updates

  1. Chris Heppner says:

    Jennie, thanks for digging this out for us all. It all –or nearly all–sounds reasonable and even helpful enough–and the short list of speakers is fine–but there is also that sentence “The objective of this research study is to begin to understand the clinical and biological characteristics of ME/CFS.” In spite of all the talk about outreach, the NIH still seems to see itself as operating in a virtual vacuum on a disease with no recorded history, no previous research, like a hitherto unrecorded island that is now being colonized, and in need of a new constitution built from scratch. And they turned down grant applications from Lipkin/Hornig and Davis.

  2. Cindy Downey says:

    It always seems to be a them and us; government medical establishment vs. top scientists outside government. Hillary Johnson defines that very well in Osler’s Web. So, yes, I agree, NIH seems to see themselves as finally discovering new territory. A very revealing statement about their view of themselves vs. the rest of the world.

    At least NIH is moving toward some positive activity. Finally! Here in the backwoods of Canada, the frozen North, the Canadian Institutes of Health Research has abandoned the ME community by saying ME (CFS) is not a disease. Our nation is scientifically embarrassed by this egregious error. This decision was obviously not based on science, but was ideologically driven.

  3. How is it going to find any people to study if it insists, for example, that they not be depressed and not be on pain meds? Few of us have no pain – or is it only some meds that will be excluded?

    Do they do that when they study other physically-acceptable diseases? Do you have to not be depressed to be in a study of diabetics?

    • Jennie Spotila says:

      Excluding for medications is very common. I assume they will work with each candidate to figure out what meds they can come off, etc.

  4. Cindy Downey says:

    I agree with the concern that only “happy ME patients”, will be eligible. Eliminating all depression is going to far.

    We have been labeled as “just depressed” for a half century or more. Now they finally want to do a study where no one with ME is unhappy with their lot. How about angry ME patients? Is it OK to be in a NIH study on ME if you’re angry?

    • Thane says:

      Of course many people with ME have depression, but I think there is merit in not including these folks in the research (where possible at least; most pwme have it to some extent). Depression, particularly severe depression, is a fatiguing illness, and this is a variable that is best controlled for when attempting to understand the underlying disease mechanism of ME. Rest assured, whatever they discover among those less depressed pwme will apply to everyone with ME.

      • Thane says:

        In fact, controlling for depression in the selection criteria will give researchers an opportunity to demonstrate that “See? These people don’t have depression and STILL we are detecting objective biological disease markers!”, proving that this disease is of a physical origin.

  5. Simon McGrath says:

    Thanks, Jennie, lots of useful info, esp in the consent form

  6. Sura says:

    Alas, I’m ineligible on several fronts. Am now over 60 (69); there’s a cut-off at 5 years of symptoms at the start of the study (I’m at 51 years and counting). Yes, I take meds to mitigate pain. Would I give them up for the duration of the study, were I eligible on all other fronts? Very scary thought – but maybe. My pain meds don’t stop the PEM (or any symptom except crushing pain), but allow me to function when I’m not in a ‘flare’ or crashed and bed-bound.

    It’ll be great to get good, current information about some of the changes the recent gut study found happening before and after 3 years of symptoms. Everything found will still be fairly early in the progression of what I now believe (from personal experience) is a progressive illness. It’ll be interesting to see what this study comes up with – but other studies have to be funded as well so the rest of us might live to benefit from the results.

  7. Donni Lockridge says:

    Finding ME patients NOT treating pain and who are NOT depressed sounds very limiting, though I can understand the parameters & purpose. I’d love to be part of a study, but I do not meet any of the restricting criteria (i.e. Age, length of illness, no depression, no pain meds)

  8. kathy d. says:

    I don’t meet the criteria, and I wouldn’t be able to stop taking pain or sleep medications. I wouldn’t be able to do a thing, even hold up my end of a discussion without sleep medications, hence, sleep.

    I also find it astounding that the NIH is in the process of “discovering” research when there’s been plenty of it. Aren’t they reading the studies that have been done and the conclusions, including Montoya, Davis, Lipkin, and the UCSan Diego study on metabolism just released, to name a few. My mind is still boggled about the lack of interest in prior studies, even those released in the last few years.

    I have plenty to say about “PEM,” as it’s called, althoug it can last for days or weeks. Maybe they’re discussing it as the IOM report discusses this. How can they omit Ron Davis, when he was on the IOM panel, is doing research at Stanford with other scientists, and has a severely ill son, Whitney Dafoe.

    I’ll wait to see what happens, but I’m not holding my breath and I do appreciate Jennie’s hard work in following all of this and posting it here.

    I wou

  9. jimells says:

    This study has *finally* been posted at the Clinical Trials website:

    In case anyone is interested, the original patient recruitment notice may be viewed here:

    It will likely be THREE YEARS before we see anything from this study:
    “Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)”

    So NIH is moving at the same snail’s pace as the ballyhooed CDC multisite study.

  10. billie moore says:

    While there is the standard, usually good, rationale for excluding those on pain or depression meds, some of the latter are actually effective for ME symptoms other than depression and are prescribed for such. My concern in this case is that the sickest people once again will not be allowed into the study or be willing to volunteer because they will not be able to give up their meds.

    And, of course, I agree completely with previous comments – this is not a new disease. It has thousands of papers written on it. Why is the NIH starting at ground zero? These people are probably, almost universally, too young or too well to see the end of their lives clearly and thus cannot comprehend the sense of urgency the ME patients feel. Thank goodness there is some private research going on.

  11. Gemini says:

    Thank you, Jennie, for publishing the names of outside ME/CFS experts NIH has brought in to update their research team. I was curious about who they would select.

    Do you know if they are getting– or have requested– patient/advocate recommendations for future speakers? It would seem an important area and opportunity for patient collaboration.

    As has been mentioned there are “recent” key ME/CFS research findings from Lipkin/Horning, Hanson, Naviaux, Davis, etc. their team should be briefed on. And, from a historical standpoint Byron Hyde should be called upon as well as Drs. Bell, Klimas, Cheney, Rowe, and several others.

  12. Pingback: NIH moving at bureaucratic pace while ME/CFS metabolomics findings get hotter! – The Microbe Discovery Project

Comments are closed.