1. Patients launch $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!
A Little Poisoning Along the Road to ME/CFS
Looking at my symptoms, many of which are far less these days and some are gone, it would be easy to figure that I'd just been dealing with some heavy-duty menopausal issues.
Discuss the article on the Forums.

Bob Miller wants your ideas for the spring FDA Stakeholders Meeting

Discussion in 'Action Alerts and Advocacy' started by Sasha, Feb 9, 2013.

  1. jspotila

    jspotila Senior Member

    Messages:
    1,074
    Likes:
    609
    I suspect that the standard required notice is 30 days or so. We typically get less than that for CFSAC meetings. A Federal Register notice will be published with all the details.
     
  2. Sasha

    Sasha Fine, thank you

    Messages:
    8,467
    Likes:
    7,565
    UK
    jspotila - Hi Jenny! I was hoping you'd turn up on this thread - you've got such expertise in this kind of thing.

    Didn't you link to someone's blog a little while back who wrote a very insightful piece about the reason that CFSAC wasn't very effective was that patients had lost the right to question speakers, so that departmental bods could spout a load of rubbish and get away with it unchallenged? I thought she had some very good points. She'd be a great contributor to preparing for this FDA meeting.
     
  3. jspotila

    jspotila Senior Member

    Messages:
    1,074
    Likes:
    609
    I think you are talking about Mary Schweitzer, who posted a comment on my blog post about the CFSAC High Priority Recommendations.

    And for those who haven't seen it, I wrote about the poor analogy between AZT and Ampligen. Bob and I exchanged some info in the comments, too.

    The biggest challenge with NIH and Ampligen is that, unlike AZT which was in the public domain, Hemispherix owns the IP for Ampligen. NIH has requirements for the clinical trials it funds, and I've heard that they require companies to give up some of the IP rights on a treatment. Hemispherix may not be willing to do that.
     
    Sasha likes this.
  4. Sasha

    Sasha Fine, thank you

    Messages:
    8,467
    Likes:
    7,565
    UK
    jspotila likes this.
  5. WillowJ

    WillowJ Senior Member

    Messages:
    3,105
    Likes:
    2,737
    WA, USA
    thanks, Jennie. (30 days only? how are people with actual full-time jobs supposed to plan?)
     
  6. WillowJ

    WillowJ Senior Member

    Messages:
    3,105
    Likes:
    2,737
    WA, USA
    I had meant to tag CJB as the second person here.
     
  7. jspotila

    jspotila Senior Member

    Messages:
    1,074
    Likes:
    609
    Good question! I find it quite frustrating.
     
    WillowJ likes this.
  8. snowathlete

    snowathlete

    Messages:
    2,184
    Likes:
    2,581
    UK
    I think there is some real promise here, but if you're a drug company and the FDA tells you that they are interested in drugs for the disease, that's great and all, but where do you start? You might put forward some drugs that might eleviate some symptoms like fatigue, but other that you probably don't know where to start.

    Maybe we ask the FDA to review existing research on ME/CFS where medications were used. As an example - and that's all this is, as its something I happen to have been looking at recently - the arsenic derived drugs used by Dr Tarello some time ago.
    I expect there are several medications that have been used in small research which showed promise but which then didn't get followed up...one of the reason why being that there was so little interest before.
    It seems to me that there may be drugs out there that have already shown some potential benefit for some ME/CFS patients, so if the FDA looked at those and engaged with the manufacuters of those drugs then proper trials might actually happen, and maybe one of them would work out.
     

See more popular forum discussions.

Share This Page