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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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Tell FDA why ME/CFS should get special attention by NOV 1

Discussion in 'Action Alerts and Advocacy' started by Hope123, Sep 27, 2012.

  1. Hope123

    Hope123 Senior Member

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    The Food and Drug Administration (FDA) is the US federal agency that drug companies submit potential drugs to for assessment and approval before the drug can be placed on the market for a specific medical condition.

    Currently, FDA has placed ME/CFS as one of 39 different medical conditions for special consideration BUT ONLY 20 WILL BE CHOSEN. If chosen, FDA will especially consider patient perspectives when evaluating drugs designated for that condition and possibly set up incentives for companies to look into that condition.

    Tell FDA about how this disease has affected you (which symptoms? severity?), how most existing treatments either help symptoms (like sleep) or are inappropriate (uncautious exercise leading to disability), and the lack of well-established treatments that get at the root of this illness. If you want future studies to take into account objective measures (instead of only asking people "how do you feel?") like natural killer cell activity or exercise testing, write about that. If you are sick of studies only looking at "fatigue" improvements but not post-exertional malaise or cognitive function or pain, etc., write about that. Talk about how historically, patient perspectives have not been considered by the government/ medical/ scientific groups and how we welcome this chance to interact.

    Deadline is NOVEMBER 1, link below for details, Green button on right to submit electronic comments. Note comments will be posted online publicly eventually so decide what you want to put down carefully.

    https://www.federalregister.gov/art...ug-development-public-meeting-and-request-for

    There is also an in-person meeting in DC October 25, the deadline for registration is Oct 18, also in above link.

    ***********************************************************************************************************

    EXCERPTS from link:

    A key part of regulatory decisionmaking is establishing the context in which the particular decision is made. In drug regulation, this context includes a thorough understanding of the severity of the treated condition and the adequacy of the existing treatment options. Patients who live with a disease have a direct stake in the outcome of the review process and are in a unique position to contribute to weighing benefit-risk considerations that can occur throughout the medical product development process. Though several programs exist to facilitate patient representation, there are currently few venues in which the patient perspective is discussed outside of a specific product's marketing application review. The human drug and biologic review process could benefit from a more systematic and expansive approach to obtaining input from patients who experience a particular disease or condition.

    FDA is committed to obtaining input from patients and, as set out in the commitment letter, will conduct public meetings to consider 20 different disease areas over the 5-year authorization of the program. For each disease area, FDA will conduct a public meeting to discuss such topics as the impact of the disease on patients, the spectrum of severity for those who have the disease, the measures of benefit that matter most to patients, and the adequacy of the existing treatment options for patients.

    FDA is nominating the following disease areas as potential candidates for the focus of one of the 20 future public meetings and invites public comment on this preliminary list. In your comments, please identify the disease areas that you consider to be of greatest priority and explain the rationale for your recommendation.
     
    GhostGum, SpecialK82 and Snow Leopard like this.
  2. SOC

    SOC Senior Member

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    Thanks, Hope, for gathering all this useful information for us in one place. This could be of great benefit to us.
     
  3. Hope123

    Hope123 Senior Member

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    Someone sent me a message about whether non-US folks could comment. The "Submit comments" form has a tab for country and includes a long list so I presume that they will consider comments from abroad as well. So I would encourage anyone from abroad to submit a comment also. You might want to explain why you're commenting -- something like how worldwide there aren't good treatments, how in some countries people have little choice regarding treatments except CBT/GET, and how US research/ policy impacts others countries.

    For the "category" in the form, choose "individual consumer" unless you fit another category.

    Thanks!

    Form: http://www.regulations.gov/#!submitComment;D=FDA-2012-N-0967-0001
     
  4. justinreilly

    justinreilly Stop the IoM & P2P! Adopt CCC!

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    submitted a comment. thanks for the heads up!
     
  5. Dolphin

    Dolphin Senior Member

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    The CFSAC have just sent out a message on this:



     

    Attached Files:

  6. Nielk

    Nielk

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    What do you think are key components to bring attention to the FDA about ME/CFS?

    I think that it is important to be smart about this since it can have a major impact whether they will pick ME/CFS as one of the 20 illnesses to concentrate on.
     
  7. SpecialK82

    SpecialK82 Senior Member

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    Excellent - just sent in my comments, now on to recruit my family - let's work on flooding them with feedback!
     
    Dolphin likes this.
  8. Hope123

    Hope123 Senior Member

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    I don't know what criteria FDA is using to select among the 39 conditions but looking at the 39, many of them do have pharmacologic and non-pharmacologic treatments that work, even if they don't cure the condition. For ME/CFS, we don't have anything that works for most people that is standardized, proven in studies, and easily available, even with MD prescription. Treatments for pain/ sleep, etc. help manage the condition's symptoms but don't get at the root of the illness. Furthermore, we don't even have a large number of active reseachers, within and without pharma, working on treatments whereas many of the other diseases do. I would not make a direct comparison to other illnesses in what is sent to FDA but rather just talk about the situation with ME/CFS.

    Another clue might be the criteria FDA used to select the 39 conditons in the first place:

    FDA also welcomes public comment on the criteria for disease area selection. These criteria include the following:
    • Disease areas that are chronic, symptomatic, or affect functioning and activities of daily living;
    • Disease areas that reflect a range of severity;
    • Disease areas for which aspects of the disease are not formally captured in clinical trials;
    • Disease areas that have a severe impact on identifiable subpopulations (such as children or the elderly);Show citation box
    • Disease areas that represent a broad range in terms of size of the affected population; or
    • Disease areas for which there are currently no therapies or very few therapies, or the available therapies do not directly affect how a patient feels, functions, or survives.
     
  9. Hope123

    Hope123 Senior Member

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    Thanks for submitting a comment, Justin! So far, out of 25 comments posted, only 1 has been for ME/CFS! I hope others have submitted comments and that they are only awaiting approval. Almost all the other comments are about ALS except for 2. We have to do better than this if we want to attract attention.
     
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  10. Dolphin

    Dolphin Senior Member

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    I know at least one other person who submitted a comment late on October 9 (US time).
     
  11. justinreilly

    justinreilly Stop the IoM & P2P! Adopt CCC!

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    Yeah, Im just seeing my comment as the only one so far for ME. Lets put up some comments up there. Maybe people are planning on doing it a little later before the Nov 1 deadline, but it doesn't hurt to just put up a short quickish little plug for ME sooner rather than later. I don't think people need to worry about it being an essay contest or anything; I sure didn't. : ).

    sorry if I'm being annoying, I procrastinate and 'schedule for later' my fair share so Im definitely not trying to preach to anyone by any means. Cheers. J
     
  12. SpecialK82

    SpecialK82 Senior Member

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    I know there have been several comments made, including my own. There appears to be something wrong with viewing the comments as these are not shown, but please don't let that deter you from commenting yourself.
     
    Dolphin likes this.
  13. Merry

    Merry Senior Member

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    Done.
     
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  14. HTree

    HTree

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    Hi All,
    I am certainly a procrastinator (one could say I allocate energy to get this done just in time...) ;) Two questions: pls point me to URL where we can view already posted comments?
    also, second, a concern: as this will be publicly available--does that include our personal information? There's part of me that hopes I will be back to work one day, sooner rather that later...and....still unsure how much I'd like my future colleagues to know about this(heinous) M.E journey...Hmm. Perhaps a selfish concern, but I suspect I'm not the only one? I wouldn't be running for a public office, but may return to some policy work...govt perhaps... soo. Thoughts on this anyone? I am so happy to vote in contests etc, but the public-comments give me pause because of the work situation...I wonder how others have thought about this?
    Thanks Friends.
    Htree
     
  15. Hope123

    Hope123 Senior Member

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    1) There are a couple ways to handle the anonymity issue. For one, there isn't a requirement you put your full name. Initials could work. Or just put in "anonymous".

    2) Not all fields in the submission form are viewable online. Per the form, only areas with a "globe" next to them are viewable. Name is not one of them but "country" 'state" and "category" are. I see "organization" is a required field but you could put "None." If none of the categories fit you in the last item, put "individual consumer."

    http://www.regulations.gov/#!submitComment;D=FDA-2012-N-0967-0001

    3) According to another page about 1,400 comments have been submitted but only 30 are currently posted. There is probably a delay with FDA reading through and posting comments.

    http://www.regulations.gov/#!docketDetail;D=FDA-2012-N-0967

    You can get an idea of what is posted publicly by looking at the comments online already. Click on the name of the commenter to see their comment. In addition, you can click the "+More" hyperlink and "HTML" symbol to get more information about the submitter. Some people sent in their comments with the full address but that is not a requirement.

    http://www.regulations.gov/#!docketBrowser;dct=PS;rpp=50;so=DESC;sb=docId;po=0;D=FDA-2012-N-0967
     
    HTree likes this.
  16. Starfive

    Starfive

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    Thanks also for the heads up. I submitted a very basic comment...not much mind available, yet maybe that is one of the points to be made.
     
    Merry likes this.
  17. HTree

    HTree

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    Detailed comment, done!
     
  18. justinreilly

    justinreilly Stop the IoM & P2P! Adopt CCC!

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    Thanks guys!
     

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