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ME/CFS Clinician Panel Lists Top Drugs to Explore at FDA Workshop

Discussion in 'General ME/CFS News' started by Gemini, Apr 28, 2013.

  1. Gemini

    Gemini Senior Member

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    ME/CFS clinicians unanimously agreed antivirals and immune modulating agents were the top two drugs they's like to explore during the FDA's Workshop April 26, 2013.

    FDA posed the question: "If you had a drug or intervention you'd like to explore, what would be your top one or two or three choice?" Drs. Bateman, Klimas, Corbin, Chu, & Montoya were on the panel.

    Dr. Bateman answered with her priority list (below) & other panel members concurred:

    1. Antivirals
    2. Immune modulating agents
    For symptom relief:
    3. Pain medications
    4. Stimulants for cognition
    5. Sleep medications
    6. Orthostatic intolerance medications

    Audience members added:
    7. Large-scale Rituxan clinical trial
    8. VO2 max agents

    This part of the meeting is on page 66 the MS Word transcription, post #125 on the FDA Workshop thread.

    Hope future FDA meetings will address the ME/CFS priority list since discussion was limited this time, "just say them, not discuss them" was asked of the panel.
     
    Tristen, Ember, beaker and 1 other person like this.
  2. Desdinova

    Desdinova Senior Member

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    USA
    What!?????o_O Much of that list flies in the face of the CDC's ME/CFS guide?:rolleyes:
    What did the FDA say about those suggestions? Most of those recommendation seems generic and not specific. Won't the FDA just run home to the CDC to see what they recommend? Isn't that basically what they do 90+ % of the time?
     
    ukxmrv likes this.
  3. Gemini

    Gemini Senior Member

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    Desdinova, you're right! :rolleyes:

    Clinicians who've treated thousands of ME/CFS patients told the FDA they want antivirals & immune modulating agents.

    FDA thanked them for their input.

    Be watching to see what FDA does about it...& how patient groups support the suggestions.
     
  4. LaurelW

    LaurelW Senior Member

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    Utah
    Ampligen is an antiviral and immune modulator. They had it right in the palm of their hands, and they let it get away....
     
  5. Desdinova

    Desdinova Senior Member

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    From what I followed they were concerned over missing data largely over patients who quite and / or dropped out with no clear reason given as to why. That was IMO just plain sloppy on the part of whomever was in charge of tracking and data collection. That combined with suicides of some participants along with some health problems with (I believe) heart issues or cancer (going by memory) was enough for them to pull the plug.

    The FDA clearly IMO gleamed it's info on CFS/ME from the CDC probably from there public website. And they're thinking what's being treated and discussed is the symptom of Chronic Fatigue along with other other various symptoms. A serious condition yes but life and death serious nope, not in their opinion. Not with missing data, unfulfilled or insufficient information given, suicides and other health issue in the picture.

    So If I'm right and they're basing their decisions largely off of whats available via the CDC's public website they'll drag their feet following up and when they do it will be a canned response.
     
    Valentijn likes this.
  6. Guido den Broeder

    Guido den Broeder *****

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    Rotterdam, The Netherlands
    Excellent list, except that I'm missing metabolic supplements / stimulants.
     
    Valentijn likes this.
  7. JT1024

    JT1024 Senior Member

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    Massachusetts
    Do you mean supplements to treat mitochondrial dysfunction?
     

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