Lipkin's Monster ME/CFS Study: Microbes, Immunity & Big Data
The Microbe Discovery Project outlines an ambitious new study by top researchers that has collected patient samples, but needs desperately funds to complete the work.
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Dr Nath's intra-mural study at NIH is currently recruiting

Discussion in 'Active Clinical Studies' started by Kati, Dec 9, 2016.

  1. viggster

    viggster Senior Member

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    Yes, volunteers to the ME/CFS study will have (online) access to all of those types of test results. But we won't have access to results from, say, the deep cytokine profiling investigation or the blood cell-to-neuron (brains in a dish) experiment, or the metabolomics stuff that NIH does. Those are experimental techniques and there's no way to interpret individual results until the whole study is complete and the healthy patients are compared to the sick patients.
     
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  2. duncan

    duncan Senior Member

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    Very cool. Thank you for checking, @viggster.
     
  3. Hutan

    Hutan Senior Member

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    I'm not expecting the results to necessarily be handed out to patients on the day they are measured. But certainly once the particular study is complete e.g. metabolomics or measurement of cytokines or fMRI, individual patients could be given their results.

    These results could help the patient and their doctors compare the individual situation with the reported findings and may therefore help the patient understand their illness better. It may possibly even result in some insights of use to the wider population of people with ME. For example, a particular referring doctor may be able to notice a pattern of response to a particular treatment in patients with a certain cytokine or metabolomic result. And that insight could trigger breakthrough research.

    The principles of data transparency and collaboration with patients should be adhered to unless there are strong reasons not to. The facts that these studies are experimental or technical are not reasons to never give the participants their own results.

    What do we know about when the anonymised data will be available to other interested parties?
     
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  4. viggster

    viggster Senior Member

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    The study is scheduled to run through 2018, probably longer. The NIH policies for data sharing for intramural (on campus) human studies is here:
    https://oir.nih.gov/sourcebook/intr...ht/intramural-data-sharing/human-data-sharing

    "...data developed in the NIH Intramural Research Program (IRP) should be collected in a manner that permits and promotes the broadest sharing possible."
     
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  5. duncan

    duncan Senior Member

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    If issues present with volunteers' results, that may well show in these early basic results such as MRI's and neuro-psych evaluations - areas where interpretation can come into play. It would be a shame if bias played a role, and I think we need to be vigilant against that possibility, while at the same time hoping for the best. Now that we know serology results and imaging results and neuro-psych results WILL be made available to participants, we need to make sure each volunteer is aware of this, as well as the procedures they must follow to access their data.

    Personally, I would like to see ME/CFS volunteers share these data as they become available with agreed-upon ME/CFS advocates - so long as volunteers are amenable to that. Alternatively, if privacy is an issue, each is informed as to what to look for in terms of red flags. This way, should interpretive questions/differences emerge, they can be confronted and hopefully resolved in real-time, and early on into the research process. Everyone benefits this way.

    Trust but verify.
     
    Last edited: Jan 10, 2017
  6. Hutan

    Hutan Senior Member

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    Thanks @Viggster.
    Intramural Research Program Human Data Sharing (HDS) Policy

    Key Points of Policy

    1. This Policy applies to all human data in the NIH IRP, including the NIH Clinical Center as well as NIH Institutes and Centers.
    2. A Data Sharing Plan (PDF File) must be developed for any research involving human data.
    3. Data Sharing Plans will be included in the institute scientific review process for research involving human data.
    4. The Institute Scientific Director (SD) or their designee is responsible for approving all Data Sharing Plans.
    5. All IRP-supported clinical investigators are expected to develop protocols and consent processes/forms to enable broad data sharing for secondary research consistent with this Policy.
    6. Sharing data for secondary research purposes shall comply with human subjects research regulations and procedures, if applicable.
    7. All IRP investigators are encouraged to deposit data in publicly accessible research repositories for sharing to the extent feasible and appropriate.
    8. This Policy is effective as of October 1, 2015. Any intramural research involving human data undergoing scientific review after October 1, 2015 must have a data sharing plan.
    The policy does look to be a good foundation. It would be good to see the Data Sharing Plan(s) for the ME research and to know how item 7 (use of publicly accessible research repositories) is addressed.
     
  7. halcyon

    halcyon Senior Member

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    My understanding is that to give patients access to this type of data at this point would possibly run afoul of FDA/CMS CLIA regulations.
     
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  8. Kati

    Kati Patient in training

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    I think that in general, patients want to know whether they 'fit the profile', belong in the cohort, and that there are distinct and measurable abnormalities that shows that indeed they are sick.

    There are currently no mainstream biomarkers, none accepted by the medical community, and beliefs that it's all in our heads. Having a proof on paper cannot come soon enough for our community.

    Complicating matters, there is distrust in at least one NIH team members, with the history that we have been wronged more than once by government bodies. The stakes are high, and probably more so for the study participants who will submit to testing that will most certainly set them back weeks, if not months and that is not counting the stress of not knowing riht away what their results are.

    Having read a few research consents myself, there is always this one sentence which I do not want to believe to be true, which says: there will not be personal benefits to you in participating in the study, but there might be benefits for the community in gaining knowledge. --> there are no promises made, there might be no conclusive results, though I do not believe that this is going to be true. I will give the example of the pathogen study in Vancouver. I think most patients were convinced they would find something. But they didn't. The paper took a good 2 years to publish. So disappointing but then, this is how it goes. No promises. It is hard to have no expectations, especially when the opportunities of government research are so few and scarce.

    I hope they find something. Fingers crossed.
     
    Last edited: Jan 11, 2017
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  9. Hutan

    Hutan Senior Member

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    Good point. But Naviaux has been providing patients with metabolomic data - so it can't be an impossible problem to solve.
     
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  10. halcyon

    halcyon Senior Member

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    Right, I think they are violating the FDA and/or CMS CLIA regulations in doing so unless they have met these requirements:
     
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  11. viggster

    viggster Senior Member

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    FYI...I volunteered for the study (after haranguing Collins to do something about ME, I figured I should) and the NIH team has been looking at my medical records. They want to see some records from before my sudden fever in July 2012 to show that I was healthy. But, like most 30-somethings, I didn't see doctors when I was healthy, so they might not take me into the study for want of documentation of my prior health. There's some measure of irony here, yes?
     
  12. viggster

    viggster Senior Member

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    For people considering volunteering for the study, here's a bit more on my conversations with NIH researchers, posted originally at Occupy ME:

    Regarding concerns about how patients will do during the NIH testing: I’ve been talking to the NIH investigators about joining the study. Dr. Walitt wanted to know how long it might take me to recover from traveling (I said three days), and he said the testing would wait until I had stabilized after a (long, for me) trip to Bethesda. He also spent a lot of time describing the testing that would be done and repeatedly asked me if I was comfortable with all of it. He also said there’s a quite a bit of flexibility and that there is no rigid 9-to-5 schedule of testing to be done. The protocol involves two trips to NIH. The second trip, some months after the first, will include physical exercise (stationary bike) and mental exercise (math problems) designed to elicit PEM. So yes, patients signing up for the study are signing up to PEM themselves. The only way NIH can study PEM is if they can see it.
     
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  13. duncan

    duncan Senior Member

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    @viggster, did Dr. Walitt provide insight into what specific types of tests would be included in the neurospych testing? They should be able to break this out for you by name of test, if they are willing.

    Also, when will that testing take place? First trip? Second? Will they divide the testing over a couple of days, or will it be in one 6 hour span? Who will administer the testing?

    I suspect if anyone knows these answers, Dr. Walitt will.

    ETA: I realize these kinds of specifics likely would not have come into your conversation. I guess it's just wishful insight on my part...
     
    Last edited: Feb 9, 2017
  14. viggster

    viggster Senior Member

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    Well I started to fade during our talk so I don't recall everything...I don't think he mentioned specific neuropsych tests.
     
  15. duncan

    duncan Senior Member

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    Thank you for reporting back your experience, @viggster.

    One of the reasons I asked about the neuropsych evaluation is that I think I remember that there are certain cognitive domain tests that seem to be more sensitive to deficits frequently experienced by pwME.

    I may be misremembering, if so, I apologize. If I am right, it would be a shame if they plan to unload the usual array of tests as they typically aren't geared to, well, us. Too blunt of an instrument.

    Also, if they intend to hurl the usual psych 150-question tank at us, the wording is deplorable and easy to manipulate - not that anyone at the NIH would ever think of doing such a thing.

    Getting a handle on what tools they intend to employ would not be unwise.

    This, of course, is not your headache. My question was a spontaneous reaction to reading of your experience with Walitt as a tour guide, so to speak.
     
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  16. RYO

    RYO Senior Member

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    @viggster
    I am currently in the process of enrolling in the NIH study. I first became ill after severe viral illness in 2012. So far, my impression is that the NIH is sincere in it's efforts to study the possible mechanisms of disease. My hope is that the data collected helps to lay the ground work for future studies. I can appreciate the skeptical comments in this thread but in my opinion, well designed and conducted studies are overdue and sorely needed. Not sure why NIH tapped Dr. Brian Walitt to coordinate study but I am hoping to meet with other researchers if I am enrolled.

    The following is a link I found by Cort Johnson which contains interesting discussion on this topic.
    https://www.healthrising.org/blog/2016/03/10/nih-long-term-effort-chronic-fatigue-syndrome/

    Also a link on Dr. Brian Walitt
    https://thoughtsaboutme.com/2016/02...e-perception-mecfs-as-normal-life-experience/
     
    Last edited: Feb 16, 2017
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  17. RYO

    RYO Senior Member

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    Here is a presentation given by Dr Nath. Very interesting and informative.
     
    Last edited: Feb 19, 2017 at 10:59 PM
  18. Knockknock

    Knockknock

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    Are you kidding me???
    Even cort johnson sound sarcastic in his post were he said !! THE ALWAY SO CAUTIOUS NIH!!!!!he repeat that about ten times during his post, that sound to me a polite way of saying stop the Bf, we al know that your policy of limited research for me/cfs hasnt change much..
    I was reading the have done very little close to nothing over the last 2 years since collins accepted the phsylogical and severity of the illness and promised all fire power.
    We still the less funded illness in the NIH even tough we are the mos negeclted and severe.
    Increase 5-6 mill to 13-14 doeant get it done.
    To me it seems they are politucaly covering their back with so much awarenes and the stagering increased in cases.
    We are 4-5 times more than HIV/AIDS
     
    Last edited: Feb 20, 2017 at 9:04 AM
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  19. RYO

    RYO Senior Member

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    I am not arguing that NIH funding is woefully inadequate or that the NIH has neglected the ME/CFS community. Have you viewed the video webinar presentation by Dr. Avindra Nath? My opinion is that his efforts are genuine.

    Are you suggesting that nothing of value can come from this intra mural study? Would you argue that this study shouldn't be conducted? Of course, I wish the NIH devoted $250 million or more to ME/CFS research. But we need more than financial resources. Listen to Dr. Nath's interview. ME/CFS community desperately needs researchers and clinicians that are even interested in studying this disease. You can't force someone to do research in an area where they have no interest.

    If I am recruited for this study, I hope to advocate for the ME/CFS community in any way that I can given the opportunity.
     
    Last edited: Feb 20, 2017 at 4:18 PM
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  20. Silencio

    Silencio

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    These are some cognitive tests I've had done, not in relation to the NIH study, but maybe a participate can comment once they know what tests will be administered. I put an asterisk after the ones that showed impairment:

    Wechsler Abbreviated Scale of Intelligence (WASI)
    Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) *
    Gordon Diagnostic Test *
    Paced Auditory Serial Attention Test (PASAT) *
    California Verbal Learning Test II – Standard Form
    Beck Depression Inventory II (BDI II)
    Spielberger State Trait Anxiety Questionnaire (STAI)
     
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