Invest in ME Conference 12: First Class in Every Way
OverTheHills wraps up our series of articles on this year's 12th Invest in ME International Conference (IIMEC12) in London with some reflections on her experience as a patient attending the conference for the first time.
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Dr. Ian Lipkin responds to the NIH ME/CFS Request for Information

Discussion in 'General ME/CFS News' started by Bob, Jun 28, 2016.

  1. Bob

    Bob

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    England (south coast)
    From the Microbe Discovery Project...

    Some interesting details in here...

    DR. IAN LIPKIN RESPONDS TO THE NIH ME/CFS REQUEST FOR INFORMATION
    June 28, 2016
    http://microbediscovery.org/2016/06...nds-to-the-nih-mecfs-request-for-information/

    Read on...
    http://microbediscovery.org/2016/06...nds-to-the-nih-mecfs-request-for-information/
     
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  2. aimossy

    aimossy Senior Member

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    I am going to quote a big block of this letter:

    "The team came together in 2011 at the request of NIH director, Francis Collins, to rigorously review evidence linking XMRV to ME/CFS. After XMRV was found to be a laboratory contaminant we continued under the auspices of the Hutchins Family Foundation- Chronic Fatigue Initiative and a patient-led crowdfunding initiate, The Microbe Discovery Project, to build an integrated, multicenter program focused on pathogen discovery, microbiome research, proteomics, metabolomics and epigenetics. With the assistance from the ME/CFS community we have amassed detailed questionnaire data for epidemiology and hundreds of blood, stool and saliva samples for microbiome, proteomic and metabolomic analyses. Our team has already identified differences between short- and long-term illness duration subsets of patients based on CSF cytokine data and has early findings that we believe will impact the lives of thousands of patients.

    In 2015, we began a one-year NIH-funded study to recruit and enroll an additional 125 ME/CFS cases and 125 healthy controls across five geographically distinct clinical sites. Each of these subjects are rigorously screened by clinical experts in ME/CFS. A wide range of biological samples are to be collected at four time points to account for seasonal variation. We have already collected 25% of the projected questionnaire data and samples; thus, we are on track to have the world’s most comprehensive ME/CFS database and sample repository by early 2017. We meet in monthly teleconferences to review progress in meeting study objectives and to focus our limited analytical resources on the most urgent research questions. Drs. Major and Unger provide linkage to the National Institutes of Health and the Centers for Disease Control, respectively, thereby insuring integration of extramural and intramural efforts.


    The following list briefly describes gaps in knowledge that we have discussed as highest priority. I have also shared this list independently with the Director of the NINDS, Walter Koroshetz.


    Microbiome (bacteriome, mycobiome, virome)
    • Characterize the microbiome of the blood, oropharynx and gastrointestinal tract in an effort to identify potential triggers of immune response or metabolic dysfunction.

    Proteomics
    • Identify biomarkers in blood and cerebrospinal fluid that can be used for diagnosis, prognosis, and to follow the course of disease and response to interventions. Biomarkers may also provide insights into potential therapeutic targets.

    Metabolomics
    • Identify potential diagnostic and therapeutic targets.

    Immunology
    • Identify biomarkers for diagnosis, prognosis as well as potential therapeutic targets; determine history of exposure to infectious agents that may trigger onset or exacerbation of ME/CFS.

    Genetics/Epigenetics
    • Identify gene variants that may be associated with specific clinical presentations or phenotypes that may predict course of illness or response to varying therapeutic interventions.

    • Identify epigenetic signatures that may be associated with ME/CFS and that may correlate with infectious or other triggers.

    Brain Imaging
    • MRI and fMRI studies to enhance understanding of the neural circuitry and inflammation associated with ME/CFS.


    To meet these urgent research needs, the CfS for ME/CFS will prioritize the following components in our “center without walls”:

    1) Patient Registry
    2) Biobank
    3) Clinician Training Program
    4) Clinical Trials


    Patient Registry
    The Patient Registry willprovide ready access to the pre-qualified, well-characterized and consented cases and controls required to obtain samples, test hypotheses, validate assays, assess the safety and efficacy of therapeutic interventions and pursue exploratory research. Questionnaires provide a wealth of qualitative and quantitative data. This registry would include instruments to assess quality of life, cognitive dysfunction, medical history, medications, and other metrics. Standardization will be key to comparing results across various studies. To maximize the registry’s utility, common data elements must be identified and incorporated and diagnostic criteria must be standardized across studies. Existing study subjects tend to be demographically homogenous, which may skew scientific findings. To diversify the sample set, studies must actively recruit underrepresented groups, such as males and ethnic minorities.

    Biobank
    A biological sample repository should be readily available to researchers across all disciplines and geographic locations. Samples will represent a wide range of human tissues and be acquired and processed at all sites in strict adherence to established protocols. Aliquots will be created in predesignated sizes for each sample type in anticipation of sample size requirements for downstream analyses to minimize excess thaw/refreeze cycles, ensure that banked samples are of optimal yield and integrity and to preserve the utility of the Biobank for long-term studies, including prospective investigations. Diverse tissue samples, including biopsy material acquired during routine or clinicallyindicated endoscopy/colonoscopy, examinations of suspicious thyroid growths as well as bone marrow biopsies will be included. Eventual integration of the biobank and patient registry would provide an unparalleled comprehensive resource for epidemiologic and physiologic investigations.

    Clinician Training Program
    Given the reticence of the medical community to accept ME/CFS as a biological illness, it is no surprise that medical schools do not include ME/CFS in their curricula and that there is no existing specialization program. Accordingly, the CfS for ME/CFS is designing a two-year Masters-level training program that will include rotations in neurology, immunology, rheumatology, clinical epidemiology, statistics and health services training to provide the interdisciplinary clinical and research knowledge needed to quickly diagnose and administer treatment to ME/CFS patients and to expand the pool of potential recruits for research studies.

    Clinical Trials
    As this group and others discover more clues to the biological underpinnings of this disease, a clinical trials program will enable research to be rapidly translated into clinical practice. A Clinical Trials Unit should be positioned to rigorously examine interventions, including probiotic/nutritional, biological (e.g., immune regulators; anti-cytokine antibodies), medication and potentially, microbiome-related (e.g., fecal microbiome transplantation, other) approaches. Subject recruitment would be enabled by the Patient Registry. "
     
    Last edited: Jun 28, 2016
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  3. BurnA

    BurnA Senior Member

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    Wow. This is very significant. A two year Masters ...to diagnose and treat ME/CFS patients.
    I know testing and biomarkers are the short term focus but this really is a game changer long term.
    Adds more knowledgeable doctors into the field and adds further legitimacy to ME/CFS. Not to mention it adds a subtle pressure on universites to improve their basic level of ME/CFS training at the least.
     
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  4. A.B.

    A.B. Senior Member

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    A brief summary:

    Several years ago, Dr Lipkin formed a group with clinicians and researchers with the goal of solving ME/CFS.

    This group thinks that the following areas should be researched:
    - Microbiomics
    - Proteomics
    - Metabolomics
    - Immunology
    - Genetics/epigenetics
    - Brain imaging

    The group is working on the following:
    - A patient registry that would allow researchers to rapidly find patients for research.
    - A biobank that would make biological samples from patients available to researchers.
    - A clinician training program in the form of a two year training program that would enable clinicians to quickly diagnose and treat patients, and also provide patients for the patient registry.
    - A clinical trials program that would systematically test treatments.

    Dr Lipkin is requesting donations from the public. (edit: for his microbiome/immunity study)
     
    Last edited: Jun 28, 2016
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  5. aimossy

    aimossy Senior Member

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    Dr. Lipkin is not exactly requesting donations from the public, that comes across a bit suggestive maybe @A.B. without it intending to be because you were summarising. The MDP team is asking for people to support the CII microbiome/immunity study, and stressing that funds are needed for the CII for this and the CoE. There is nothing in that letter to NIH from Dr. Lipkin requesting donations from the public for all these things that are summarised.

    Edit: Just as a side note if some don't know. A team of patients got together to try and help get funds to great researchers who still don't have enough funds. The MDP project was successful in initial goal, eventually, and raised over 1.5 million dollars. The study was hugely expanded in scope and parameter, making it even more rigorous, and now it needs a huge amount more in funding to get analysis done. Still no full funding from NIH. They did get some funding to help with collection of samples but it didn't cover any where near the cost of collection.
     
    Last edited: Jun 28, 2016
  6. valentinelynx

    valentinelynx Senior Member

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    Tucson
    I am a bit puzzled by this. I am a physician. I don't get how or where a "a two-year Masters-level training program that will include rotations in neurology, immunology, rheumatology, clinical epidemiology, statistics and health services training to provide the interdisciplinary clinical and research knowledge needed to quickly diagnose and administer treatment to ME/CFS patients and to expand the pool of potential recruits for research studies" would fit into a physician's training, either during or after the traditional training period. MD's don't generally get Master's degrees during their training. Two years is half of a traditional residency period (the training a doctor does to enter a specialty after getting an M.D. degree).

    Normally such super-specialization would happen after residency and be called a "fellowship," e.g. training in pain medicine after finishing an anesthesiology residency, or in cardiology after finishing an internal medicine residency. Perhaps Lipkin is talking about a fellowship in ME/CFS? That would be an extremely limited specialization - don't know of any other such training focused on one disease.

    I'm not saying this is a bad idea. I just don't understand what it actually means.
     
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  7. duncan

    duncan Senior Member

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    I am curious about the brain imaging being proposed. I see only MRI's. No SPECT scans? No PET scans?

    Cost probably factors into this, but cost aside, each of these technologies approaches brain imaging differently. Each, accordingly, affords the researcher different data. Who is to say which data set won't prove a game changer?

    I am particularly puzzled by the lack of SPECT scans. The NIH seems these days to eschew SPECT scans as well when it comes to neuro-lyme, even though researchers like Logigian have demonstrated the utility of SPECT imaging in neuro cases.

    (Btw, I'm also interested to know what level of MRI. For instance, it has been my experience that the Alzheimer researchers at the NIH use a more powerful MRI vs the Lyme group (3.0 vs 1.5?). Arguably the result is better data. So, which MRI technology?)
     

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