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FDA considering drugs for ME/CFS? Give comments

Discussion in 'Action Alerts and Advocacy' started by Sushi, Oct 25, 2012.

  1. Sushi

    Sushi Moderator and Senior Member Albuquerque

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    [​IMG]



    P.A.N.D.O.R.A., Inc. - Patient Alliance for Neuroendocrineimmune Disorders Organization for Research & Advocacy, Inc. · 2,481 like this
    6 hours ago ·

    • The FDA is considering ME/CFS for its patient-focused drug development initiative. It is one of 39 diseases under consideration, but only 20 will be chosen for the 5-year project. Today, Mary Dimmock and Joe Landson, both who have attended PANDORA's Advocate Extraordinaire™ programs, are attending the meeting and gave public comment. The FDA wants to hear how CFS has affected you. Post your comments here:http://www.regulations.gov/#!docketDetail;D=FDA-2012-N-0967
     
    taniaaust1 likes this.
  2. heapsreal

    heapsreal iherb 10% discount code OPA989,

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    All the antivirals approved for active herpes viruses in cfs/me so they arent prescribed off label and hard for some people to get.

    Also sleep meds approved for long term use in cfs/me not just the standard 2 weeks as that doesnt help chronic ongoing sleep problems.

    Also xyrem approved for cfs/me sleep issues.

    Immunoglobulin therapy approved not only for defiencies but also for hard to treat infections.

    Interferon, same as immunoglobulins.

    Immunovir for low nk function and t-cell function in cfs/me

    Adrenal hormones dhea/hydrocortisone for low levels in cfs/me

    Im sure there is more and all these things are available but only off label which makes it hard for many people to get these treatments as many docs arent familiar with them. If they were specifically indicated for cfs/me with outlines on how to use and prescribe them then more people will have access to them. Also helps people to get it covered by insurance and countries like australia then these can be subsidised by our health system. I also think it will spurr interest in looking for more treatments too.

    cheers!!!
     
  3. taniaaust1

    taniaaust1 Senior Member

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    The drugs Ive found useful for my ME symptoms and have taken or are still on are:
    - Clonazepam (anxiety.. neurotoxicity symptoms)
    - Metaclophamide (nausea)
    - Florinef (POTS and raise lowered blood volume)
    - Clonidine (helps some autonomic dysfunction issues ME causes eg swinging BP it helps balance (I get both high and low BP due to the autonomic dysfunction). It also lowers the high noradrenaline which many of us have.
    - Melatonin (sleep)
    - Temazepam (sleep)
     
  4. taniaaust1

    taniaaust1 Senior Member

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    I was going to post a comment on the FDA thing but their submit a comment form has me confused... in the "catagory section".. would catagory would be pick? Would it be the "consumer group"?
    ...

    edit .. I just saw that right at the bottom of that catagory section there is a section for Individual consumer..so I just tried to comment by selecting that. Thing is it wont allow me to post my comment as its coming up wanting me to put in an organisation name (its highlighted that area ).

    so then I wondered if I was trying to comment in the wrong area so went to the link part "feedback and questions" but it then comes up saying "
    Please do not submit comments or submissions on specific regulatory documents using this form as they cannot be forwarded to the proper Federal agencies via this mailbox. "

    So I assume that other part, the link you provided is the right part to post comment in but then how does one do this if it wont allow one to post if they arent part of an org?
     
  5. Sushi

    Sushi Moderator and Senior Member Albuquerque

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    What about putting PANDORA? I haven't tried yet, but that is the organization announcing this to us.

    Sushi
     
  6. SpecialK82

    SpecialK82 Senior Member

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    taniaaust - just write in "none", that's what I did. It just needs something in that field to proceed.
     
  7. medfeb

    medfeb Senior Member

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    The FDA used the following criteria in developing their initial recommendations. It would be good to reference these criteria in your comments if you can:

    1. Disease areas that are chronic, symptomatic, or affect functioning and activities of daily living
    2. Disease areas that reflect a range of severity;
    3. Disease areas for which aspects of the disease are not formally captured in clinical trials;
    4. Disease areas that have a severe impact on identifiable subpopulations (such as children or the elderly);
    5. Disease areas that represent a broad range in terms of size of the affected population
    6. 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.
    The FDA wants to understand the severity of disease from the perspective of the patient, the types of treatments that are available and whether they affect your overall level of functionality.

    Comments are due by November 1.
     

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