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The Chronic Fatigue Initiative and Interview with Mady Hornig
In a follow-up article to the recent IACFS/ME conference presentation in San Francisco, and after speaking at length with Dr. Mady Hornig, 'searcher' delves deeper into the impressive work being completed by the Chronic Fatigue Initiative, and focuses in on those cytokine results ...
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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. Sasha

    Sasha Fine, thank you

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    It's a long time since I filled that in and I think there's maybe an option like 'patient' or 'customer' or something. Can anyone else remember? Can you post a link to the thing you're looking at? I'm about to go out so perhaps someone else can help. :)
  2. anniekim

    anniekim Senior Member

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    Thanks Sasha. I'll just put patient. On my iPad and can't do link
  3. medfeb

    medfeb Senior Member

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    Anniekim
    Yes, people outside the U.S. can write to the FDA. You can also answer the two surveys if you havent already. Links are in the article.
  4. Bob

    Bob

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  5. Whit

    Whit Senior Member

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    Ronald W. Davis, PhD, Professor of Genetics and Biochemistry and Director of the Stanford Genome Technology Center at Stanford, is doing research on CFS. He thinks it would be a good idea for all of us to comment on this federal workshop for CFS and wrote the following for me to send this out. Unfortunately I've been really sick and haven't been able to. But here it is now. If this contradicts something in the above article then go with what PR is suggesting. But maybe this will be good motivation.

    There is a public workshop called "Drug Development for Chronic Fatigue Syndrome and Myalgic Encephalomyelitis; Public Workshop" held in Washington DC on April 25 and 26.

    http://federalregister.gov/a/2013-05562

    Two things they are trying to determine are "the most significant symptoms that you experience resulting from your condition" and "the most negative impacts on your daily life that result from your condition and its symptoms." They expect patients to go to Washington DC to explain their condition, but of course only the least sick could possibly go. However, patients can email or write if it is received by April 8, 2013.

    [Whit's note:
    Only write about physical symptoms. I know we also suffer from mental symptoms as a result of our physical illness, but do not give them any excuse to write this off as a mental illness. Do not write about emotional symptoms. Tell them about your emotional symptoms by telling them the physical things that cause them, and leave out the emotional aspect. ]

    Here is how to make online comments:
    Go to:
    www.regulations.gov
    There is a big search box
    Type in-
    Docket No. FDA-2012-N-0962
    Click on "comments" for this current CFS/ME workshop.
    Fill in your information and comments.

    Submit written comments to:
    Division of Dockets Management (HFA-305)
    Food and Drug Administration
    5630 Fishers Lane, rm. 1061
    Rockville, MD 20852
    (refer to Docket No. FDA-2012-N-0962 at the beginning of your letter.)

    This is an outstanding opportunity to get on the public record the devastating effect of CFS.
    Even if nothing happens as a direct result of the on site meeting, the government could not ignore CFS if 100,000 people responded describing the level of their disability. History has shown that the government acts if there is a significant march in Washington DC. But what about a disease so devastating that patients can not get to Washington DC and could not march even if they could get there. An email/written effort might substitute for a march if it is made clear they can not travel or march. If you are really sick, just write what you can. Even writing "I am too sick to write more than this one line" will be beneficial. For those of you that don't trust the government keep in mind there are only two groups that have enough resources to solve CFS; The government and a collection of most of the patients. Things have been so bad, so ignored, for so long, but this is a time when we might really be able to have our voices heard.

    It would not be a good thing if this workshop only recorded the responses of people well enough to go there. That would be a false impression of the true effects of this illness. It seems that this might be a window of opportunity to really make our voices heard. Even just to get thousands of responses on the record would provide great citations for people writing grants in the future. There is a rising tide of research now, and we need to do everything we can to provide the impetus for funding. Tell them what it's like. Get your friends, family and doctors to write. Let's motivate them to finally do something about it!
    SpecialK82 and snowathlete like this.
  6. Sasha

    Sasha Fine, thank you

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    Thanks, Whit - I'm sorry you've been so sick.

    It's great that your dad took the time to write - we need more like him!
  7. Ember

    Ember Senior Member

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    A virtual march on the FDA? Only 88 comments received so far:
  8. Nielk

    Nielk

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    The march of words!

    Make your words count.
    Ember likes this.
  9. Ember

    Ember Senior Member

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    As shown here, 126 comments have been received.

    This document shows today as the due date for comments to receive consideration:
  10. SpecialK82

    SpecialK82 Senior Member

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    Jennie Spotila explains in her latest blog http://www.occupycfs.com/ that the docket will be open until August 2 to receive comments. Possibly the April 8 deadline was for the comments to be included in this meeting. However, please continue to send your comments in now after April 8 if you haven't done so, I'm sure that these will still be considered in the total count at the end of the day.
  11. Whit

    Whit Senior Member

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    From OccupyCFS-
    "If you want to submit written comments, you have until August 2nd to post comments through the meeting docket. The docket page currently says it will close on April 8th, but FDA has said in the Federal Register and in communication to advocates that the docket will be open until August 2nd."

    Can someone else confirm this? It would be good to make sure before sick people spend time writing comments.
  12. Ember

    Ember Senior Member

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    Bob quoted the relevant source earlier:
  13. Whit

    Whit Senior Member

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    Great news! Hopefully we can build up more comments. Since there's more time and I have a tiny bit of energy, I've got some questions about the comment form.

    1) It appears the comments are google searchable, and if we use our full name, they may appear in a google search for our name. This may bother some people. But it seems that full name is not required. Do comments have more impact if we give our full name?

    2) I had no idea what to put for the "organization name" or "category", and both were required. Forgive me if I've missed explanation of this elsewhere. But it would be good to clarify.
  14. Bob

    Bob

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    My understanding is that all comments, and uploaded documents, may become public both online and in other literature such policy-review documents etc etc.

    Here is their privacy notice:
    http://www.regulations.gov/#!privacyNotice

    In the online form, any part of the form with a 'world' symbol next to it, will be displayed publicly.
    So it looks like they will not publish individual names, but will publish the 'Organisation Name' and 'Submitter's Representative' name.


    I suppose that "ME patient" or "patient" would be appropriate for the organisation name.

    For the 'category' list, go to the bottom of the drop-down list, and you'll find 'individual consumer'. I think this looks most appropriate for a patient.

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