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"NINDS Director Expresses Shock (and Awe) at Community Response to Clinical Center Study Protocol"

Discussion in 'General ME/CFS News' started by Sasha, Feb 13, 2016.

  1. Sasha

    Sasha Fine, thank you

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    Report by Cort (I am a poet and I do not know it! :)):

    The rest here:

    http://www.cortjohnson.org/forums/t...ponse-to-clinical-center-study-protocol.3652/
     
    Aurator, nandixon, Dolphin and 10 others like this.
  2. Sasha

    Sasha Fine, thank you

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    Snippet:

    I agree with Cort's estimation of Carol Head. Hugely impressive.
     
  3. sarah darwins

    sarah darwins I told you I was ill

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    What, no moaning about 'militant patient activists' or 'harassment'? Who are these people???
     
    Rick Sanchez, leela, beaker and 16 others like this.
  4. worldbackwards

    worldbackwards A unique snowflake

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    They aren't getting into the spirit of the thing.
     
  5. Nielk

    Nielk

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    Why did the private funding issue even come up? NIH funds other similarly burdened diseases exponentially higher that ME/CFS, yet NIH throws it back in our face that we should raise private funding?

    Why take a defensive ground to wax plain why we don't raise more private funding?

    Why it puttheburden where it belongs? The NIH!

    Where is the urgency and pressure on NIH that they have totally underfunded this disease for thirty years!!

    They have funded AIDS in this time period 500,000 times more and now AIDS is on its way out.

    AIDS patients and their family and friends didn't let NIH get away with neglecting them. They fought like it matters. We need to do the same.
     
    leela, beaker, jimells and 3 others like this.
  6. Nielk

    Nielk

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    Another perplexing info.
    If this is true that advocates and Silve have had input with the NIH team in preparation of this study, how did they get everything so wrong?
     
    beaker, duncan and RustyJ like this.
  7. Nielk

    Nielk

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  8. Valentijn

    Valentijn Senior Member

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    "Madness" seems like a rather hyperbolic term, under the circumstances. And since the NIH is aware of our concerns, and seems to be in the ongoing process of responding to them (hopefully by rectifying the problems), it seems rather premature and excessive to demand the trial be stopped entirely.

    I'm all for some good fist-shaking when appropriate, but I also think we need to keep our eye on our goals. And right now, surely it's more beneficial to steer the NIH toward productive research instead of putting an end to such research entirely.
     
  9. Nielk

    Nielk

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    I agree with you that we need to keep our eyes on our goals - an NIH productive intramural study. That is exactly what the petition is calling for.

    There is an urgency here because in two days, Dr. Nath of the NIH will be presenting about this study at the CDC Grand Rounds. Thousands of American clinicians will be listening in. If what Dr. Nath will present is a "fatigue" study, including the comparison cohorts which they have suggested, the damage will have been done. thousands of clinicians will now go on to treat ME patients as if they simply have fatigue.

    We are asking them to stop the clock and start from scratch. This is not a matter of just a few simple changes. This study needs an overhaul in its design. It needs guidance from ME experts who have see and followed patients as a well as input from the patients community.
     
    dancingstarheart likes this.
  10. Valentijn

    Valentijn Senior Member

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    The petition clearly states that it is calling for the study to be canceled. I don't think that is a reasonable or constructive demand at this point in time.
     
    shannah, Kati, Riley and 7 others like this.
  11. ScottTriGuy

    ScottTriGuy Stop the harm. Start the research and treatment.

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    The petition is another form of fist-shaking, in addition to the phone calls, emails and other communications from the community which has (finally) garnered the NIH's attention - cumulatively they all pressure the NIH to review the research protocol.

    And just to play devil's advocate a bit further while were demanding protocol change, perhaps the petition should include demands that the patient population be collaborators - 'no research about us, without us' type thing - or perhaps even a community-based research approach.

    HIV patients have the MIPA Principles: Meaningful Involvement of People with HIV/AIDS - (it was previously GIPA, Greater Involvement of People with HIV/AIDS but evolved into 'meaningful' after HIV+ folks where used as necessary tokens on committees, boards, etc.)

    https://www.afao.org.au/__data/assets/pdf_file/0017/12680/AFAO_MIPA_Policy_30413.pdf

    "In 1994, the Paris Declaration formalised international commitment to enable greater
    participation of people living with HIV (PLHIV) in the development of responses to HIV:

    The success of our national, regional and global programmes to confront
    HIV/AIDS effectively requires the greater involvement of people living with
    HIV/AIDS ... through an initiative to strengthen the capacity and coordination of
    networks of people living with HIV/AIDS. ... By ensuring their full involvement in
    our common response to HIV/AIDS at all national, regional and global levels,
    this initiative will, in particular, stimulate the creation of supportive political, legal
    and social environments.

    The Declaration committed the 42 signatory governments to develop and support structures,
    policies and programs to facilitate the greater involvement of people living with HIV. As
    understanding of the impact of GIPA has increased, the international commitment to
    the GIPA Principle has grown.

    In 2001, 189 United Nations member countries endorsed the
    GIPA Principle as part of the ‘Declaration of Commitment on HIV/AIDS’. The Principle was
    further endorsed by 192 Member states at the 2006 High Level Meeting on AIDS, where the 2006 Political Declaration on HIV/AIDS was unanimously adopted.

    GIPA aims to realise the rights and responsibilities of people living with HIV, including the
    right to self determination and participation in decision making processes that affect
    the lives of positive people. GIPA brings the unique experience of living with HIV to policy and
    program development: a contribution that is now understood to be vital to the development
    of effective HIV responses.

    GIPA extends modern thinking around meaningful “consumer”
    participation in health programs and policy development and expands notions of
    ‘consultation’ to define ‘involvement’ as including full participation, including decision making
    roles related to HIV/AIDS research, program development, policy making, advocacy and
    activism. GIPA also increases the public profile of active, productive people living with HIV,
    which impacts public stigma and discrimination against all people living with HIV."
     
    dancingstarheart likes this.
  12. Sasha

    Sasha Fine, thank you

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    Just to note that it's not OK to change what a petition is asking for midstream because you don't know if the signatories that you've got so far would have agreed. They've already signed and you can't change what they signed up to without their permission.
     
    Kati, Never Give Up, adreno and 5 others like this.
  13. Nielk

    Nielk

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    This is what the end of the petition states:

    It would help if people would actually read the petition before they criticize it. - http://www.meadvocacy.org/http_www_meadvocacy_org_stop_nih_study
     
    dancingstarheart and ScottTriGuy like this.
  14. Valentijn

    Valentijn Senior Member

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    It states that the current study must be canceled. Which probably involves a lot more delay and bureaucracy than fixing the problems with it. And risks the research (and attached funding) disappearing entirely.
    Perhaps re-evaluating ME Advocacy's knee-jerk reaction to everything, and the failure to adapt to a changing situation might also be helpful?

    I did read the petition, and I considered it to be unreasonable. I understand that the petition was a very premature response to the proposed study when nothing was known beyond what was accidentally put online by the NIH. But the situation has changed, and doggedly sticking with that premature response isn't productive and does not inspire any faith in the organization.

    A similar thing happened with the IOM contract. Most of us were opposed to it based on their previous work on GWS. Then the report came out, and it was very good. Most of us were pleased by the change, and we were no longer opposed to the IOM contract. But ME Advocacy refused to change track once it was committed to destroying the IOM process, and continued to attack it.

    So ME Advocacy just might benefit from taking their finger off the trigger, and finding a way to take a more nuanced stance short of "EXTERMINATE" for everything that they dislike at first. While it is obviously a good idea to get prepared and start discussing problems the moment they become apparent, it's not a good idea commit to a specific course of action when very little is still known.

    Instead of racing to be the first on the scene, perhaps ME Advocacy could avoid being stuck over-reacting to a situation, by waiting a bit and gathering more information first?
     
    AndyPR, Aurator, geraldt52 and 11 others like this.
  15. Roy S

    Roy S former DC ME/CFS lobbyist

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  16. Nielk

    Nielk

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    It was accidentally put on the NIH website? Little munchkins came during the night and accidentally typed Reeves criteria in there with all the other ridiculous items? How naive can one be? In addition, time was of the essence because this is going to be disseminated to the pubic in two days. Acting as apologists for the government and sending in polite questions will not take care of this. Just like it has done nothing for our community in the past 30 years. It is time for action and for NIH and CDC to feel the urgency and pressure. We don't have years to try to get this right. About every month now I hear of another suicide in this community. I have had enough.

    MEadvocacy takes advice from long time US advocates who advise us on our direction. It might be that non-US patients are very happy with the IOM criteria but the majority of the US patients are NOT. It is another set of loose criteria where a patients with no immune or neurological symptom can be diagnosed with.

    MEadvocacy is the only patient organization that is totally transparent and direct about this subject. We represent a large chunk of ME patients who are grateful that we take action instead of sitting back and giving the appearance that we have a seat at the table and influence with the government.

    Patients are sic and tired from hearing patient's org. claim that they have influence with HHS. They have promised this for decades and relied on patient funding them to do so. Where has it gotten us? Nowhere!

    AIDS patients who rebelled in a very loud at time violent ways, have had huge NIH funding and 30 years later, their disease is practically eradicated. In this same time frame, ME/CFS orgs. have colluded with the government. They have constantly agreed with whatever the government threw at us. With -0- results. How many of the over 100 CFSAC recommendations have gotten acted upon?

    Collins still thinks that this is all about fatigue. If you want more of the same, then continue supporting those orgs who do not advocate for patients but for their own relationship with the government.

    We are better off with no intramural NIH study than with one concentrating on fatigue and a large percentage of US advocates and patients agree with MEadvocacy.
     
  17. Nielk

    Nielk

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    Carol head states:

    What response do you think that Dr. Koroshetz was talking about?
     
  18. BurnA

    BurnA Senior Member

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    Are you talking about defining a new set of ME criteria ?


    The community response. I don't think anyone has said that this is a great study lets get on with it. Everyone has expressed some reservation or another. The point is, not everyone wants to cancel the study and reinvent ME criteria while we are at it. A lot of people believe this can be turned into something good and that a corner may even be turned already.
    The point is, the response may have done its job, there is no need to prolong or extend the response for the sake of it. It's time to see how the NIH reacts and then lets see the next, or official, study protocol before we can say anything else.
     
    meadowlark, Snowdrop, Riley and 3 others like this.
  19. dancingstarheart

    dancingstarheart

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    Excellent explanation! This is an urgent issue due to the CDC presentation by Dr. Nath. I have heard no one on PR addressing any concern about this presentation. Why is that?
     
  20. dancingstarheart

    dancingstarheart

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    This is stretching for reasons not to put a stop to this study and all based on fear, and helplessness to the whims of NIH, worrying that NIH will just decide drag their heals or not fund a study at all. And those those feelings are very validated, because NIH has not funded to study this research above $5 - 7 million over the last 30 years. And still has not committed to the funding increases the patients have been demanding.

    But giving into this fear is very dangerous given this study is going to be discussed at a CDC presentation just 9 days after news got out about the study. A presentation that has been scheduled for months. A presentation to thousands of medical practitioners and the public. How can that not be urgent to make sure a bunch of garbage information is not adding further to the bias of the medical community that we all experience? As Carol Head said "We noted that bad research is worse than no research, and “garbage in / garbage out” will occur if the criteria for defining “ME/CFS patients” is not meticulous and highly attuned." http://cfstreatment.blogspot.com/2016/02/new-nih-study-raises-doubts-concerns.html That statement also applies to presenting bad information to public.

    Excuses that cancelling a study would delay the paperwork process is presumptuous. NIND officially posted that study as an approved protocol. That means they had to go through an investigation review board type process to have approvals. If it truly was a draft, that process had not been done. But I do not believe that "draft" interpretation/rumor/ spin.

    Koroshetz was shocked that patients were upset at the study, according to Carol Head. So that means NIND's personnel had no idea how badly it was designed. That whole process will have to be redone. Koroshetz never did communicate or confirm to Carol that was a draft (a draft is devoid of approvals). He did not say it was, and his response of shock indicates to me that if it was not finally approved, the study was near the end of the drafting process. He would not have been shocked if he knew they had a newer better draft, and that one could have easily been posted. But no, the feedback from a meeting between the Millers and an undisclosed NIH/NIND person only mention changes in criteria use... Not addressing the problematic cohort comparisons, etc.. Those were remaining. Where is the transparency this patient community needs? There was never an announcement by the Millers that they were meeting with a person from NIND, a meeting they admitted was already scheduled before their knowledge of the posted study. And they feel that they cannot directly quote or even reveal their contact's name? Why is that?
     

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