1. Patients launch a $1.27 million crowdfunding campaign for ME/CFS gut microbiome study.
    Check out the website, Facebook and Twitter. Join in donate and spread the word!
ME/CFS and the Magic of the Canine Factor
There's been plenty of research indicating that having pets is good for your health. I never really noticed any particular benefits to having cats, though that may have had more to do with my cats. They've been fairly indifferent to my presence and we've shared a live-and-let-live...
Discuss the article on the Forums.

FDA Drug Development Workshop: Part One

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

  1. Desdinova

    Desdinova Senior Member

    Messages:
    272
    Likes:
    124
    USA
    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

    Messages:
    2,001
    Likes:
    1,993
    UK
    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

    Messages:
    272
    Likes:
    124
    USA
    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

    Messages:
    7,497
    Likes:
    8,735
    England, UK
    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.
    snowathlete and Nielk like this.
  5. Andrew

    Andrew Senior Member

    Messages:
    1,945
    Likes:
    1,189
    Los Angeles, USA
    What caused the FDA to listen to patients? How did it come to pass that somebody sought our input?
  6. Bob

    Bob

    Messages:
    7,497
    Likes:
    8,735
    England, UK
    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.

See more popular forum discussions.

Share This Page