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!
Dr. Kerr, I presume?
Clark Ellis brings us a rare interview with British researcher Dr. Jonathan Kerr who is now living in Colombia.
Discuss the article on the Forums.

FDA Teleconference for ME/CFS Stakeholders

Discussion in 'Action Alerts and Advocacy' started by Nielk, Aug 17, 2012.

  1. Nielk

    Nielk

    Messages:
    5,273
    Likes:
    5,292
    Queens, NY
    http://www.research1st.com/2012/08/17/fda-call/

    EMAIL MESSAGE RECEIVED FROM THE FOOD AND DRUG ADMINISTRATION (FDA)
    August 17, 2012
    [​IMG]
    Dear Colleagues:

    The U.S. Food & Drug Administration (FDA) is pleased to invite you to a stakeholder teleconference between FDA and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) patients and advocacy organizations on September 13, 2012. Dr. Janet Woodcock, Director of the Center of Drug Evaluation and Research, will lead the call. The purpose of the call is to discuss issues of mutual interest and concern including the lack of approved treatment options available for ME/CFS and how treatment development might be facilitated.
    The teleconference is scheduled for Thursday, September 13, 2012 from 10:00 am – 11:30 am. Registration is required and must be received by September 7, 2012. Early registration is recommended because telephone lines will be limited to the first 50 groups and/or individuals who register. FDA may limit the number of participants from each organization, as well as the total number of participants, based on current space limitations.
    If you would like to participate, please send your name, email address, telephone number and affiliation information to Randi Clark (randi.clark@fda.hhs.gov) by no later than September 7. Registrants will receive confirmation and additional information about the teleconference once registration has been received and accepted.
    FDA looks forward to your participation.
    Thank you,
    Dominic Cirincione
     
    Omar88, WillowJ and CJB like this.
  2. justinreilly

    justinreilly Stop the IoM & P2P! Adopt CCC!

    Messages:
    2,490
    Likes:
    1,175
    NYC (& RI)
    My Dad (former lawyer at FDA) and I have both signed up. See you guys there!
     
    SOC, WillowJ, CJB and 1 other person like this.
  3. Sing

    Sing Senior Member

    Messages:
    1,310
    Likes:
    430
    New England
    In case I can't participate that day, I sure hope that someone brings up the issue of the FDA holding up the drug Northera made by Chelsea Therapeutics which is a replacement for norepinephrine and which is supposed to be
    the most effective drug yet for hypotension. It has been used successfully for years in Europe and Japan. It is
    currently being aimed at Parkinson's treatment and possibly for Fibromyalgia, but we ought to be a target patient population as well. Many of us need to be able to try this drug, as Orthostatic Hypotension is a very, very limiting conditions. I didn't have this when I first got ME/CFS but over time, I have been developing our full range of symptoms, and so may many others here. So let's get vocal about our need for this, and hopefully other EFFECTIVE drugs for ME/CFS.
     
    justinreilly and Sasha like this.
  4. justinreilly

    justinreilly Stop the IoM & P2P! Adopt CCC!

    Messages:
    2,490
    Likes:
    1,175
    NYC (& RI)
    Randi Clarke who is organizing this meeting said that this was a preliminary meetiNg to get some input and find out what topics to address at the stakeholder meeting. No date yet set for that second meeting.
     
  5. justinreilly

    justinreilly Stop the IoM & P2P! Adopt CCC!

    Messages:
    2,490
    Likes:
    1,175
    NYC (& RI)
    There are plenty of points to be made. It seems to be that Ampligen is way over due for approval. But I am not a science person, so other people here can speak much more credibly on that topic. One point I think they need to hear is they need to get credible info and input on the disease, so they should be looking to sources such as ICC and CCC papers NOT CDC, NIH or Wessely School misinfo. It seems very probable that this misinfo has skewed their past decisions on Ampligen.
     
    Bob and CJB like this.
  6. WillowJ

    WillowJ Senior Member

    Messages:
    3,102
    Likes:
    2,729
    WA, USA
    that sounds cool. do you have a name or anything?
     
  7. Sing

    Sing Senior Member

    Messages:
    1,310
    Likes:
    430
    New England
    Justin, I connected my concern about the delay on Northera, the norepinephrine precursor, to the fact that OI is a very common symptom for us, and referred to the CCC and ICC (spelled out for them). Although the FDA aren't researchers, they do link drugs to diseases with certain characteristics, and when there are serious symptoms and no treatments, the FDA's reviews of drugs for that are supposed to be expedited.

    If our disease were just another form of Depression, however, what treatments could there be but anti-depressants, exercise and cognitive therapy? And if our disease is basically fictitious, then no treatment or drug would be appropriate. So, linking the need for medications to the most correct definition is a key factor.
     
    justinreilly and CJB like this.
  8. justinreilly

    justinreilly Stop the IoM & P2P! Adopt CCC!

    Messages:
    2,490
    Likes:
    1,175
    NYC (& RI)
    Thanks Sing. I wasn't referring to your post in my comment, of course, just putting out there a fundamental point I plan on making to them. Just kind of thinking aloud.
     
  9. Sing

    Sing Senior Member

    Messages:
    1,310
    Likes:
    430
    New England
    No, Justin, I think you are right. I didn't feel criticized, but rather that it is a very helpful point to bring up. We need the best definition going in order to see progress.

    I did hear from Randi Clark who said that many people had signed up for this call and she will be in touch later about the timing--also that it is only a pre-planning call so they won't be going into the subject of specific medications.

    So, lean back, we are in for a long ride.....
     
  10. CJB

    CJB Senior Member

    Messages:
    743
    Likes:
    387
    Oregon
    Did anyone get in on this?


    FDA Opens Dialogue

    CONFERENCE REPORTS, POLICY MATTERS, RESEARCH NEWS | 13. SEP, 2012 BY ADMIN | 2 COMMENTS
    [​IMG]
    Ten representatives of the Food and Drug Administration (FDA) participated in a teleconference with ME/CFS stakeholders to provide a brief update on the regulatory agency’s role and activities to facilitate drug approvals for ME and CFS. The 90-minute call was announced last month and registration was open to 50 pre-registrants. Thestated purpose of the call was to “discuss issues of mutual interest and concern including the lack of approved treatment options available for ME/CFS and how treatment development might be facilitated.”

    Sandra Kweder, M.D., deputy director of FDA’s Office of New Drugs, led the call for the agency. She provided a brief overview of the agency’s role in the drug approval process and addressed several issues of particular concern and importance to ME/CFS stakeholders. The majority of the time was spent hearing from and responding to questions and concerns raised by members of the public, most of whom were individuals with ME and/or CFS (by their own designation) who had been ill for 10, 20, 25 years or more. The CFIDS Association’s CEO, Kim McCleary, and scientific director, Dr. Suzanne Vernon, participated in the call.
    These announcements were among the statements provided in the overview and in response to participants’ questions:
    • The FDA considers ME/CFS to be a “serious and life-threatening” condition, making applications for marketing approvals to treat ME/CFS eligible for expedited review and other incentives.
    • FDA uses the term ME/CFS to indicate inclusiveness of the conditions defined by ME and CFS criteria. As stated in background information for the call, “Drug development focuses on quantitative measures of benefit (e.g., symptom improvement), not on the name of the disease. Therefore, for the purpose of drug development, the reference of ME/CFS does not mean that FDA views the two diseases or syndromes as the same.”
    • There are presently 8 open investigational new drug (IND) applications for indications for ME and/or CFS. Most are preliminary, for small numbers of individuals and the products being tested are mostly nutrutional supplements.
    • FDA will provide an overview of the drug approval process at the next meeting of the federal CFS Advisory Committee on Oct. 3-4.
    • FDA will host a webinar in mid-November on “excellence in advocacy” to advise groups and individuals about common themes that may help them be more effective in working across sectors to accelerate the drug discovery, development and approval process for ME/CFS.
    • On Dec. 20, 2012, an FDA advisory committee will hold an open meeting to discuss the application for new drug approval for Ampligen submitted by Hemispherx Biopharma. Under current FDA regulations, a decision on the application will be made by Feb. 2, 2013.
    • FDA will convene a scientific stakeholder meeting, open to the public, in spring 2013 to identify measurable outcomes that can be used in clinical trials to evaluate the effectiveness of therapies. FDA will involve academic researchers, clinicians with long-term clinical experience in ME/CFS, patients and advocates in this meeting.
    • Forthcoming FDA guidelines on “enrichment strategies,” where a subgroup of patients within a diagnostic classification may demonstrate enhanced benefits of a treatment, may be useful to advance treatment of ME/CFS.
    The FDA has established a new web page to house information about drug development for ME/CFS: http://www.fda.gov/Drugs/NewsEvents/ucm319188.htm
    A transcript of today’s teleconference will be posted to the above FDA website within a week.
    FDA asks that correspondence about ME/CFS be directed to the following email address: ME-CFS-Meeting@fda.hhs.gov
     
    Omar88 and WillowJ like this.
  11. Ember

    Ember Senior Member

    Messages:
    1,728
    Likes:
    1,781
    Jennie Spotila has posted a summary.
     
    WillowJ and CJB like this.
  12. CJB

    CJB Senior Member

    Messages:
    743
    Likes:
    387
    Oregon
    Great report from Jennie.
     
    SOC, jspotila and Ember like this.
  13. lnester7

    lnester7 Seven

    Messages:
    1,244
    Likes:
    1,123
    USA
    How can one see the drugs that are in the list? Example I am treated with imunovir, Who proposes this drugs the Dr? the Advocacy group????? I also know inosine is used, hypopressin? something like that and all the others.....
     
  14. WillowJ

    WillowJ Senior Member

    Messages:
    3,102
    Likes:
    2,729
    WA, USA
    a drug company must make an application.

    It seems they'd realized the drug companies did not know what targets to use to show improvement in ME and CFS patients (evidently they aren't interested in using the Chalder Fatigue Scale and brainwashing patients to say fatigue is a little better! -my commentary entirely). She says if the companies do not know what is expected of them, they will not do drug research. So, they made a plan.

    This is mentioned in a post above. FDA will be holding a workshop (series of workshops?) including other government orgs, the science community in general, and drug companies. They will be working on identifying targets for measuring improvement (and also for what medicines should attempt to correct?). This could be biological, or it could be "making salad" (they got excitied when one caller said treatment made her able to make salad again... happy that a treatment brought this level of improvement and started talking about how they could generalize 'making salad' to other patients. Another patient said 'salad' would apply to her, and two patients said they use stairs as their benchmark instead).

    But as there are drug companies at these stakeholder meetings, it seems worthwhile to mention at those meetings what drugs are being used that we find helpful. There are 1 million of us in the USA, 1 million in Europe, and so forth. We are a big market, and if the drug companies could expand any of their existing products to us, it would be a good return for a smaller investment (they'd still have to do clinical trials but the drug is already made).
     
  15. WillowJ

    WillowJ Senior Member

    Messages:
    3,102
    Likes:
    2,729
    WA, USA
    in fact, you can probably use the email at the website, to suggest medications to be re-purposed to us
    posted above, but here it is again:
    http://www.fda.gov/Drugs/NewsEvents/ucm319188.htm
     
  16. WillowJ

    WillowJ Senior Member

    Messages:
    3,102
    Likes:
    2,729
    WA, USA
    Thanks, Jennie, for the great report
     
    jspotila likes this.
  17. Ember

    Ember Senior Member

    Messages:
    1,728
    Likes:
    1,781
    The transcript has been posted.
     
  18. Ember

    Ember Senior Member

    Messages:
    1,728
    Likes:
    1,781
    Here's an excerpt from the transcript:
     

See more popular forum discussions.

Share This Page