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ME/CFS: A disease at war with itself
We can all agree that ME/CFS is a nasty disease, particularly in its severe form, but there are abundant nasty diseases in the world. What is unique and particularly confounding about our disease is that so much controversy surrounds it, and not only surrounds it, but invades it too.
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Historic FDA Stakeholder Meeting on ME/CFS, April 25-26: How To Have Your Say

Discussion in 'Phoenix Rising Articles' started by Phoenix Rising Team, Mar 26, 2013.

  1. Phoenix Rising Team

    Phoenix Rising Team

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    View the Post on the Blog
    View the Post on the Blog
    ahimsa, Simon, Ember and 1 other person like this.
  2. Misfit Toy

    Misfit Toy Senior Member

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    2 hours from me......Hmmm...
  3. Sasha

    Sasha Fine, thank you

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    The joint letter from our advocates and advocacy organisations (including PR) is great:

    https://dl.dropbox.com/u/89158245/LetterFDAWorkshopMar18.pdf

    I appreciate all the hard work that went into making sure we speak with one voice - we're much more likely to be heard that way.
  4. jimells

    jimells Senior Member

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    On which day will they discuss budgets? Our rulers have decreed that Austerity is the order of the day. Without a real commitment to funding, this is likely just another exercise in CYA.

    I liked the letter. Has the FDA responded to it?
  5. Mark

    Mark Acting CEO

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    No response yet as far as I know, though I believe there have been conversations with them to clarify details. I'll post updates here when I hear any news.
    Ember likes this.
  6. SpecialK82

    SpecialK82 Senior Member

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    Thank you to all who were a part of providing this comprehensive article. I found it very helpful and informative and was pleased to read the joint letter sent to the FDA concerning the confusing case defintions and critieria. I hope that the FDA will agree that the best start to this meeting would be to define what we are all talking about.

    The hard work and dedication by our patient population beforehand has increased the odds of a successful meeting I'm sure. Heartfelt thank to all! :thumbsup:
    Sasha likes this.
  7. snowathlete

    snowathlete

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    Thanks for the article, which is really helpful. I think this is one of the most important jobs of PR and other ME/CFS organizations; timely reporting of key informaiton like this in an easily digestable format for patients, so that patients can be aware and respond actively where needed in a coordinated effort. With many patients not well enough to go find out all this stuff on their own, its a critical role.

    I agree with the objectives of the letter. I think getting those four points taken aboard by the FDA might be optimistic, but that of course isnt a reason not to make the request and the pressure them for it.

    The letter suggests "recognized ME clinician and researcher experts - experts like Drs. Klimas, Rowe, Montoya, Peterson, Chia and Bateman."

    To you and me, we know what that means, because we know these doctors take the illness seriously, do not treat it like a psycological illness, and have a lot of experience with the illness. But do the FDA know that is what we mean? And even if they do, will they admit they know what it means and take appropriate steps? My fear (based partly on the fact we already know they havent invited people who they clearly should invite) is that they would invite those people they consider to be "recognized experts" but who we dont want anywhere near the meeting. By the sounds of things there is some dialogue going on between the FDA and the organizations behind the letter, so I expect there is a good chance they will get that message clearly enough.
  8. Mark

    Mark Acting CEO

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    Note that I've just updated the article with some changes and additions to Part 1 of the 'How You Can Take Action' section: some more details on how to make comments in person at the meeting.
  9. medfeb

    medfeb Senior Member

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    Hi Jimells

    We do not have an official response to the letter. The only response that we have is the information posted in the FDA Workshop FAQ which was posted after the letter was sent.

    Regarding funding - the meeting is being held by the FDA to gain the attention of the pharmaceutical companies and get them to invest in drug development for the disease. FDA's role in this is regulatory guidance and review/approval, not funding of studies. Typically, the company with the drug funds the trials although I understand that NIH has funded/does some fund clinical trials - especially early ones

    Besides for investment by pharma, funding by the government will be important and for that we will need to look to NIH.
    SpecialK82 likes this.
  10. medfeb

    medfeb Senior Member

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    The list is not complete yet but some of the experts we listed have been invited -
    Lucinda Bateman, Nancy Klimas, José Montoya, Peter Rowe, Christopher Snell.

    I expect to see others as they are confirmed on this page:
    http://www.fda.gov/Drugs/NewsEvents/ucm319188.htm
  11. snowathlete

    snowathlete

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    Thanks for the update medfeb.
    Someone from each of the five labs involved in the Ampligen trials should be invited I think; it seems daft to me that they arent invited, as they know first hand some of the hurdles to getting a drug trial to succeed, what did and didnt work, and so on.

    Here is the list of partisipants: http://www.fda.gov/downloads/Drugs/NewsEvents/UCM320307.pdf
    I hope they have a big room.
  12. Ember

    Ember Senior Member

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    This is the speaker list, as of March 20, I believe:
    The link that you posted is to the ME and CFS Stakeholder Teleconference Participant List (September 13, 2012).
    snowathlete and ahimsa like this.
  13. Bob

    Bob

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    I haven't read through all of this (very useful) thread yet, so I may be repeating stuff.
    But I just want to post some info relating to using the FDA's online comment form:
    http://www.regulations.gov/#!submitComment;D=FDA-2012-N-0962-0004


    Please note: it seems that any submitted comments will be made available on their website for public viewing/reading, including any attached documents. I don't think that they publish the commenter's name, so it should be anonymous, as far as I understand. Except the 'Submitter's Representative' details will be made public, when given.

    Here are their FAQs, in relation to posting comments, in case helpful:
    http://www.regulations.gov/#!faqs;qid=6-2


    Their comment form gives details of how to make a submission via snail mail, as follows:

    Comments: Submit either electronic or written comments by April 8, 2013, to receive consideration. Submit electronic comments to www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document*. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. Electronic or written comments will be accepted after the meeting until August 2, 2013.

    * The relevant docket number is:
    FDA-2012-N-0962-0004

    This is the FDA notice that we are commenting on:
    http://www.regulations.gov/#!documentDetail;D=FDA-2012-N-0962-0004
  14. Bob

    Bob

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    Something to note...

    The FDA are looking for what they call 'measurable endpoints'.

    They are looking for the best way to measure if a treatment has worked or not, in relation to CFS/ME.

    The example that they give, for measurable endpoints (these are not ME-specific), is a decrease in blood pressure, or an ability to walk for an increased period of time.

    So if anyone has any strong ideas about this, it would be worth submitting them.

    I think it's very important that they do not use subjective measures of self-reported 'fatigue' etc., like they used in the PACE Trial, but use objective measures, such as an objectively measured increase in walking ability.


    (Sorry if this is repetitive... I still haven't fully read this thread yet.)
    SpecialK82 likes this.
  15. Bob

    Bob

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    In relation to Phoenix Rising's (very helpful) Joint Letter to the FDA, I just spotted this in their literature:
  16. Ember

    Ember Senior Member

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    In the joint letter to the FDA, its authors write:
    The letter accordingly asks for assurance that “the FDA will encourage researchers and drug sponsors to use disease appropriate clinical trial inclusion criteria, like those seen in the Canadian Consensus Criteria, to avoid the overly broad patient cohorts that have stalled progress in the past.”

    The FDA's subsequent statement (FAQS), however, seems biased toward “the continued mixing of ME with unrelated fatiguing conditions:”
    Because CFS (Fukuda) explicitly identifies a set of “clinically evaluated, unexplained cases of chronic fatigue,” however, the FDA's own logic, along with the International Consensus Panel's recommendation, should mean that sponsors who define the disease using CFS (Fukuda) for clinical trials will exclude, by definition, cases of ME.

    The joint letter also asks for assurance “that the workshop will focus on ME...and not on the vaguely defined, overly broad 'CFS.'” But by using “the terms 'CFS' and 'ME'...interchangeably” and by prevaricating on the subject of disease definitions, the FDA has planned for a workshop that will likely focus on CFS instead, ignoring the distinctive nature of ME. It's like deja vu all over again.
  17. anniekim

    anniekim Senior Member

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    Pem/pene is my biggest problem, pain second. I am bedridden. If I remain lying flat, I just have enough energy to read a little, go online a little, have some short conversations. If I go over this at all, ie, crawling to the toilet, walking a couple of steps, the post exertional neuro immune exhaustion kicks in and I am too weak to do anything but lie there staring at the ceiling, with my manageable pain becoming much more severe and unmanageable.

    If the mechanisms behind pene/pem could be identified and drugs developed to at least mitigate the pene my quality of life would be improved. I've always felt it's the pene that is the hallmark of this illness
  18. anniekim

    anniekim Senior Member

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    Can people outside the US write to the FDA? Thanks
  19. Sasha

    Sasha Fine, thank you

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    I have! Nothing to lose. The drug developers want info about ME - I don't see why it would matter what country the patient is in who provides them with that info.
  20. anniekim

    anniekim Senior Member

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    Ok,thanks Sasha. Will submit a comment. When filling in the basic details, what do I put in for organisation's name which is a required field? Thanks

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