1. Patients launch a $1.27 million crowdfunding campaign for ME/CFS gut microbiome study.
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The Chronic Fatigue Initiative and Interview with Mady Hornig
In a follow-up article to the recent IACFS/ME conference presentation in San Francisco, and after speaking at length with Dr. Mady Hornig, 'searcher' delves deeper into the impressive work being completed by the Chronic Fatigue Initiative, and focuses in on those cytokine results ...
Discuss the article on the Forums.

FDA Workshop on Drug Development for CFS and ME

Discussion in 'General ME/CFS News' started by Ember, Feb 21, 2013.

  1. Marco

    Marco Old blackguard

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    Near Cognac, France
    Thanks Sasha

    I thought I read somewhere in the preamble that questionnaires with blank fields wouldn't be saved but maybe that doesn't apply to the introductory questions.

    I'll give it a go.
  2. lnester7

    lnester7 Seven

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    I saw In FB that Dr Elander was not invited???? I was wondering if the specialist can apply to talk even if they were not invited as in the patient side!!!!
    justinreilly and taniaaust1 like this.
  3. Sushi

    Sushi Moderator and Senior Member Albuquerque

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    I am not clear on how to access the first survey (I have done the Jason one). Is there a link to an actual survey with questions that we can answer electronically?

    Sushi
  4. Sasha

    Sasha Fine, thank you

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  5. Sushi

    Sushi Moderator and Senior Member Albuquerque

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    Sasha likes this.
  6. jspotila

    jspotila Senior Member

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  7. Desdinova

    Desdinova Senior Member

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    So who else isn't invited? First I hear Dr. Peterson wasn't invited because they say he only treats with Ampligen. And now Dr Elander wonder what their excuse is for him?
    JohnnyD and Ember like this.
  8. taniaaust1

    taniaaust1 Senior Member

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    **note to myself so I dont loose it and hopefully will see this post of me if I read this thread again.... that I've done this survey but still have the other one to do another time.
    Desdinova and Sasha like this.
  9. Ember

    Ember Senior Member

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    What is the status of this version of the ICD-10-CM? Does Diagnostic Code G93.3 as shown below reflect the Coalition 4 ME/CFS proposal, submitted to NCHS in July 2011 requesting that CFS be reclassified? Is ME to be removed as a diagnosis and replaced with CFS?
    The Coalition 4 ME/CFS provides no information, its website having been disabled.
  10. snowathlete

    snowathlete

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    We have an interview with Dr Enlander coming shortly, and In it he says that we should ask the FDA why? as in, why they havent invited him and others. Out of the five clinics involved in the Ampligen trial, the FDA only invited people from two of them. Its nuts.
    justinreilly, JohnnyD and Ember like this.
  11. taniaaust1

    taniaaust1 Senior Member

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    I can thou understand why the FDA wouldnt want to invite a doctor from ALL five of the clinics involved in Ampligen trial... they probably want a balanced drug focus at this meeting and not for it to be all about just "one" drug. I hope they've invited other ME speicalists who are treating their patients in various ways eg with antivirals etc. Maybe we should be making sure they've done that and with all the focus on Ampligen..that all the other things which are helping some of us dont go ignored.
  12. snowathlete

    snowathlete

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    I think maybe that's the thinking behind it but its a bit flawed in my opinion. These doctors are not just Ampligen doctors they know a lot about the illness. Some like Enlander are also in the process of researching other drugs too, which is enough of a reason alone i feel, and finally, their Ampligen experience is vital because they have insight into some of the reasons why the trial didn't work and produce good enough data for the FDA.
    justinreilly, WillowJ and Sasha like this.
  13. Ember

    Ember Senior Member

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    PANDORA Org and other advocates are hosting a strategy and training meeting, on Friday, April 5, for those who will be giving written or in-person comments to the FDA:
  14. JohnnyD

    JohnnyD Senior Member

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    December 20, 2012 FDA AdCom transcript is now available

    http://www.fda.gov/downloads/Adviso...rugs/ArthritisAdvisoryCommittee/UCM345463.pdf

    A summary by a HEB yahoo poster (kleinhopper)
    ------------------
    Dec 20th 2012 Adcomm transcript is up

    Not sure if this has anything to do with volume and price movement today but I just noticed the transcript from the Adcomm is up. 429 pages of data mining, have at it. I am going to skip to the end to see what what actually said during the votes.

    Following are some key quotes on the final vote (this is what I have been waiting for.) I listened to the Adcomm but everything happened so fast at the end that there was less clarity than what is in the transcript The bottom line is that the committee was UNANIMOUS in thinking Ampligen is likely effective in helping at least a sub-group of CFS sufferer

    Dr. Hennessy (yes): “I voted yes, which suggests that I'm interested in seeing a flexible regulatory approach to this drug.”

    Dr. Komaroff (no): “I think the opportunity with this drug might be substantial, and I certainly would encourage further well-designed and conducted studies.”

    Dr Gardner (no): “I would like very much to see work done on the subgroup that would reduce the concern down from perhaps a million people into some appropriate subgroup that would get the benefit that would be worth the risk going forward. So I'm hopeful that the agency and the sponsor will be able to narrow the target.”

    Dr Ware (no): “I'm comfortable with the way Dr. D'Agostino has summarized things.”

    Dr. Dagostino (no): "when you look at the database, I think it's encouraging that there might be some efficacy."

    Dr. Gualtier (no): “While I believe that there's a lot that's encouraging here and there's significant need, I'm hoping that the more careful, well-monitored study takes place, and also careful collaboration between the agency and the sponsor to do that.”
    Ms. Perry (yes): “I just think my biggest concern with this vote today is, what is going to happen to those patients who need this drug? I'm disappointed by the vote”

    Dr. Buckley (no): “I think -- and I think that's uniform -- that there may be a signal here of a drug that can help patients”

    Dr. Russell (no): "I think we should give the sponsor
    encouragement to do a very careful, well-monitored study because I think there is a signal here, and it has potential in this disorder."

    Dr. Marshall (yes): "I think, as my colleagues have already indicated, there clearly is a signal here. It's probably a subgroup issue. It's not good for everyone. Ten years from now, we can still be parsing and arguing with good studies as to which subgroup it's going to work."

    Dr. Unger (no): “there is something there, and I wish the data had been clearer.”

    Dr. Rudorfer (yes): “I think that we have enough information in hand to make this drug available now. I think the FDA has it within its power to label it appropriately, for example, not indicated for mild illness.”

    Dr. Borish (yes): I primarily just wanted to send a message that I really think there's a signal here that this drug works, and I would love to see the right study being done very quickly
    .
  15. Ember

    Ember Senior Member

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  16. jspotila

    jspotila Senior Member

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  17. JohnnyD

    JohnnyD Senior Member

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    It looks like Dr. Peterson is going to participate in the workshop regardless of being invited. :)

    ============
    SIMMARON RESEARCH, INC
    Cordially invites you to the following presentation:
    Scientifically Redefining CFS/ME By
    Dr. Daniel Peterson
    Dr. Isabel Barao
    Gunnar Gottschalk
    Thursday, April 25th, 2013
    9 AM - 12 NOON
    Marriott-Bethesda, 5151 Pooks Hill Road
    No reservation required! Open seating
  18. SpecialK82

    SpecialK82 Senior Member

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    Actually the FDA workshop begins at 1:00 PM on Thursdsay. So this annoucement is about his own seminar immediately before that. However, because he will be there in town, I'm sure he will at least be at the FDA meeting too.
    snowathlete likes this.
  19. JohnnyD

    JohnnyD Senior Member

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    Correct, he was not invited to present, so he created his own presentation. Perfectly timed and placed (IMO, a three hour presentation by one of the worlds most experienced, scientific and empathetic CFS docs is about right). Good for Peterson.
    justinreilly, Sasha and Ember like this.
  20. Nielk

    Nielk

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    Sasha likes this.

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