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FDA Workshop on Drug Development for CFS and ME

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

  1. Ember

    Ember Senior Member

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    Can't ME be diagnosed using ICD-9-CM? I've taken this explanation from the National Alliance for Myalgic Encephalomyelitis:
  2. Ember

    Ember Senior Member

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    I had thought that the ICD-10-CM coding for ME and CFS was to be under “Diseases of the Nervous System:"
    But I hadn't thought that equivalency had been decided:
    Here (in part) is the NCHS Option 2:

    G93.3 Other disorders of the brain

    G93.3 Postviral and other Chronic Fatigue Syndromes

    G93.3.1 Postviral Fatigue Syndrome
    Myalgic Encephalomyelitis

    G93.3.2 Chronic Fatigue Syndrome
  3. SOC

    SOC Moderator and Senior Member

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    Since when is what the CFSAC recommends actually what happens? I was reading the ICD-10-CM itself.

    I don't care to argue this point. I looked up the ICD-9-CM and the ICD-10-CM, but I'm happy to be wrong. If I am.
  4. Ember

    Ember Senior Member

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    Can you post that for me, SOC? Or show me how to access it?
  5. SOC

    SOC Moderator and Senior Member

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    Ember likes this.
  6. Ember

    Ember Senior Member

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    Thanks, SOC. As I read this version of ICD-10-CM, PVS is classified in Chapter 6 under "Diseases of the Nervous System" at G93.3. It subsumes CFS (also known as ME), and it's “applicable” to benign myalgic encephalomyelitis:
    Meanwhile, the National Alliance for Myalgic Encephalomyelitis recommends that ME be diagnosed under ICD-9-CM: "According to a CDC ICD coding representative (July 2006), 'M.E. has always been indexed to code 323.9. That is the code number that patients should be assigned. Correctly diagnosing this disease benefits patients and health care providers by acknowledging the true prevalence of ME in the U.S.'"

    2013 ICD-9-CM Diagnosis Codes > Diseases Of The Nervous System And Sense Organs 320-389 > Inflammatory Diseases Of The Central Nervous System 320-327 > Encephalitis myelitis and encephalomyelitis 323-
    ICD-9-CM 323.9 converts approximately to:

    2013 ICD-10-CM Diagnosis Codes > Diseases of the nervous system G00-G99 > Inflammatory diseases of the central nervous system G00-G09 > Encephalitis, myelitis and encephalomyelitis G04-
    ME would seem, then, to qualify as a smaller population of patients with an orphan condition, deserving the attention of the FDA "office of orphan products." With reference to the ICC, we'd "be able to articulate what the subpopulation is."
  7. Ember

    Ember Senior Member

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    FDA Scientific Stakeholder Workshop Needs Your Input

    By Bob Miller on March 6, 2013
  8. JohnnyD

    JohnnyD Senior Member

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    Here is bob's full post:

    -----------------------
    • Dear Patients, Patient’s Loved ones and Friends,

      Since I ended my hunger strike, I have learned that the FDA has sent invitations for the ME/CFS stakeholder workshop scheduled for April 25-26th. The FDA hasn’t disclosed who it is inviting, and did not solicit input from patients. You, the patients, made this FDA stakeholder meeting happen, and we believe patients need to be involved in setting the agenda and ensuring that the most valuable clinical expertise is represented at the meeting.

      Therefore, Ampligen patients and I are asking you to email the FDA and Secretary of Health to urge them to invite the most experienced ME/CFS clinicians who use the most sophisticated treatments available and to host an Ampligen Roundtable in conjunction with the FDA scientific and stakeholder workshop. The lessons that are being learned from the Ampligen trials will benefit every ME/CFS patient.

      During my hunger strike, the FDA and Secretary Sebelius’s office were inundated with emails and phone calls, and congress people heard from their constituents. I humbly thank you for all your work during those days; our coming together raised the attention of our federal agencies on our health crisis. Once again we need to ACT together by emailing and phoning the FDA to have our voices heard. There is a template email/letter below. For those wishing to use it, just copy and paste for ease. The Cc is to me allowing me to calculate the number of emails sent.

      For the health of Our ME/CFS community,

      Kindly,
      Robert Miller &The Ampligen Team

      Email To:
      Secretary of Health Kathleen Sebelius, FDA Commisioner Dr. Margaret Hamburg, CDER Deputy Director Sandra Kweder, David Banks in FDA Office of Special Health Issues

      Phone contacts: Please call in to make a personal request if you can:

      •FDA Commisioner, Dr. Margaret Hamburg (301) 796-5000
      •Mr. David Banks, Office of Special Health Issues (301)-796-8459
      ---------------------------------------------------------------------------------
      See Email Template Below:

      Email To: kathleen.sebelius@hhs.gov; margaret.hamburg@fda.hhs.gov; Sandra.Kweder@fda.hhs.gov; david.banks@fda.hhs.gov

      ME-CFS-Meeting@fda.hhs.gov; ampligenteam@gmail.com;

      SUBJECT: ME/CFS FDA Scientific Stakeholder Workshop

      Dear Secretary Sebelius, FDA Commissioner Hamburg, Dr. Kweder and Mr. Banks,

      FDA states that the upcoming FDA scientific workshop and stakeholder meeting on ME/CFS is the right place to address the path forward for treatments, including but not limited to Ampligen. There is a serious unmet need in the patient community for medical treatment, and Ampligen is the only medicine that has been tested in clinical trials for ME/CFS in the last 20 years. However, we understand that the few clinicians with extensive experience using Ampligen have not been invited to the workshop to share their understanding of clinical endpoints related to this debilitating illness.

      As a patient with ME/CFS, I am strongly urging FDA to do three things regarding the ME/CFS science and stakeholder workshop:

      1.The FDA should invite Dr. Daniel Peterson, who has undeniably the most experience treating patients with Ampligen and has among the most sophisticated understandings of clinical endpoints, enabling him to identify likely responders by subgrouping patients for various treatments, not limited to Ampligen. In his role as Scientific Advisor to Simmaron Research Foundation, he is collaborating in scientific studies into the immunological abnormalities of ME/CFS, including the NIH and CFI multi-site studies. His clinic has the highest response rate to Ampligen. That, along with his 30-year clinical experience, necessitates his input into future treatment pathways

      2.FDA should hold an Ampligen roundtable with the most experienced Ampligen clinicians, patients, the sponsor and the FDA, CDC and NIH representatives, in conjunction with the FDA workshop. No other medication is, or is about to be, in advance studies for treating ME/CFS or has shown such promise. The experts need to collaborate on a path toward approval for Ampligen, so current Ampligen patients can continue to have access to the drug and many other patients and their doctors can decide if Ampligen might work for them. The benefit of clinical knowledge gained from identifying those who respond to Ampligen is imperative. After FDA denied the application for Ampligen’s approval in February, it posted a statement, saying “To assist companies with their development, FDA is sponsoring a workshop in spring 2013 focused specifically on ME/CFS drug development.” And Dr. Hamburg has stated, “We are committed to continuing our dialogue with companies, innovators, patients, and other stakeholders to identify barriers to progress and better define what steps need to be taken to overcome any obstacles to innovation.” This is the time to learn from Ampligen, as well as other experts.

      3.I also urge FDA to invite Robert Miller as a patient representative. Mr. Miller has taken the lead among patients in urging federal health agencies to pursue smart science and effective treatments for more than 10 years. He played a large part in getting the FDA stakeholder meeting scheduled. His longtime experience in the Ampligen clinical trial gives him a perspective that is necessary to represent patients who participate in the only clinical trial available, as distinct from any of the patients who have been invited thus far. He is a leader among ME/CFS patients generally.

      Our understanding is that this stakeholder meeting is designed to identify endpoints for measuring efficacy, so that more clinical trials can be set up and a path to approved treatments and drugs will be established and clarified.

      As an ME/CFS patient my voice should be represented at this critically important meeting.

      Your Name Here___________
      Years ill ______________
      City and State ______________

  9. JohnnyD

    JohnnyD Senior Member

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    I think everyone, as Stakeholders, should call Hamburg's office and ask for a list of Participants for the April 24th, 25th meeting.
  10. Mark

    Mark Acting CEO

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    I like your thinking Johnny, and your take on what a 'stakeholder' is - that seems like a good step to me, because I would like more information about this. Perhaps a mass phone call isn't necessary though: if somebody is able to obtain this information they can post it here.
  11. Ember

    Ember Senior Member

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  12. SpecialK82

    SpecialK82 Senior Member

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    Thanks for posting the link Ember. I am looking forward to the drug re-purposing portion the most, this is something, if handled correctly, could help us relatively quickly. :)
    Ember and WillowJ like this.
  13. WillowJ

    WillowJ Senior Member

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    SOC likes this.
  14. Ember

    Ember Senior Member

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    Apparently, “for purposes of this workshop, the terms 'CFS' and 'ME' have been used interchangeably in describing the conditions:”
    But ME, as defined by the ICC, isn't the name of the disease; it's a defined subset:
  15. Ember

    Ember Senior Member

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    Occupy CFS -- Jennie Spotila
    March 19th, 2013
    snowathlete likes this.
  16. Sasha

    Sasha Fine, thank you

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    Thanks, Ember - I thought Jenny's new post was important enough for its own thread so I set one up.
    jspotila likes this.
  17. Sasha

    Sasha Fine, thank you

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    Ember and Valentijn like this.
  18. Ember

    Ember Senior Member

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  19. Marco

    Marco Old blackguard

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    Does anyone know if the second survey is open to those outside the USA?

    I'd really like to participate in this but the second survey asks for which US state you live in and won't save if you leave this field blank.
  20. Sasha

    Sasha Fine, thank you

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    I left it blank and carried on with no problem. Unless my memory's gone (very possible).

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