1. Patients launch $1.27 million crowdfunding campaign for ME/CFS gut microbiome study.
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Can You Come for a Visit? My ME/CFS Says No
My daughter and son-in-law just had a baby last week. We are thrilled. But we won't be able to see the baby or hold her any time soon. We won't be able to take over little gifts or help out with housework or babysitting.
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FDA Drug Development Workshop: Part One

Discussion in 'Phoenix Rising Articles' started by Mark, May 3, 2013.

  1. Desdinova

    Desdinova Senior Member

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    That's what I understood her to mean as well. But I still fear that the FDA didn't understand that at least not fully. Thinking that our fear is causing the crash itself as in psychosomatic wise. Some of what I have watched of the FDA event has me concerned.

    I think all the patients did a great job of trying to convey and explain to the FDA what we experience. But I still see ( pick up ) a sense of bewilderment, disbelief and skepticism as if they're (FDA) having a hard time of processing, understanding or accepting what they've been told.

    I can't help but feel that they are almost psychoanalyzing everyone (not just the patients) and what they say on the ME/CFS side. Trying to make it fit what they've probably gleamed from the NIH, CDC and UK NHS.
     
  2. snowathlete

    snowathlete

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    I don't know, I didn't really get that impression myself, but I'd be interested to hear if anyone else thought that.
    Regardless, I think it is important that patients who weren't at the meeting, submit their comments to the docket, which they can still do. It is especially important to highlight anything that was missing, or may have been missunderstood at the meeting itself.
     
  3. Desdinova

    Desdinova Senior Member

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    I'm still working my way through it so I hope I'm wrong and just being overly concerned. I'll try watching them a second time if I'm able to and if they're still available to see If my perspective changes.
     
  4. Bob

    Bob

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    I agree with snowathlete here. I thought that they were sincere and receptive, and that they were genuinely approaching the subject afresh. When they discussed anxiety and fear, I thought that the officials were genuinely absorbing the information in an unbiased way, and acknowledged the difference. That was my own perception of the events. I was very encouraged by the whole process.

    Yes, this is important. They say they are listening to all of us, so we have a chance to have our voices heard, and our experiences understood.
     
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  5. Andrew

    Andrew Senior Member

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    What caused the FDA to listen to patients? How did it come to pass that somebody sought our input?
     
  6. Bob

    Bob

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    I don't know if these have been posted before.

    The FDA have released the official transcripts.

    FDA conference website:
    http://www.fda.gov/Drugs/NewsEvents/ucm319188.htm

    Transcript 1 (Day 1):
    http://www.fda.gov/downloads/Drugs/NewsEvents/UCM354951.pdf

    Transcript 2 (Day 2):
    http://www.fda.gov/downloads/Drugs/NewsEvents/UCM355406.pdf


    Also, there's a very short summary of the conference. I don't know if this is new:
    http://www.fda.gov/downloads/Drugs/NewsEvents/UCM353896.pdf

    An interesting/promising extract from the summary:

    "This facilitated discussion with patients with CFS and ME provided a particularly valuable opportunity for FDA to hear in patients’ own words about how they experience their disease. For instance, one patient, when discussing a clinical term associated with the disease, “post-exertional malaise,” noted that she considered this aspect of ME-CFS to be more like “post-exertional collapse,” with exacerbation of multiple disease symptoms. Many patients shared stories of having had successful and productive lives prior to contracting CFS and ME but now struggle with even the simplest tasks of daily life. They also shared stories of debilitating episodes of CFS and ME that last days, weeks, months, and even years, before abating."
     
    Sasha and snowathlete like this.

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