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CFSAC Input Template

May 10th, 2013

If you subscribe to the CFS Advisory Committee email list, then you may have seen the preliminary agenda that went out last night. The High Priority recommendations list was not on it BUT we have confirmed with Dr. Nancy Lee that it WILL be on the agenda. There is very little time left for you to submit written comments or sign up for a speaking slot, and I’ve had some requests for ideas on what to send in. I’ve drafted a template that you can customize with your own comments or use as is.

If you want to sign up for a speaking slot, you must do so by May 15th. If you want to submit written comments to be part of the official record of the meeting, you must email them in to CFSACMay2013@seamoncorporation.com by May 15th. Written comments are limited to 5 single-spaced pages in 12 point font, and Word format is preferred. Do not include sensitive information like your birth date, address, etc on the document as it will be posted to the CFSAC website and be part of the public record. You can submit your comments anonymously.

The template that follows can be customized as you wish, or use as is – but I think it’s more effective if you customize the comments. I’ve selected what I believe are the top five recommendations, but again, feel free to customize with your own choices. The full text list of recommendations is here.

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First, I wish to thank the FDA for last month’s Drug Development Workshop. The meeting was an excellent example of how agencies can engage advocates in positive and productive dialogue. I hope that other agencies will follow FDA’s example, particularly as NIH and CDC continue to develop new case definitions.

Second, I would like to share with you the five recommendations that I believe you should designate as the highest priority for the Secretary. As the FDA meeting showed, these priorities are fundamental to getting new treatments approved and many of them have been recommended by this Committee more than once.  I urge you to include the full wording of these recommendations as originally passed, not the edited versions that appear in the CFSAC Recommendations Chart.

  1. NIH should fund ME/CFS research commensurate with the magnitude of the problem, and issue an RFA specifically for ME/CFS.  You made this recommendation in May 2011, and included an edited version of it in your original High Priority List. This Committee has made recommendations to increase NIH funding into ME/CFS research many times, but this recommendation asks for “funding commensurate with the magnitude of the problem,” and I believe that is critical language to be included in the high priority list.
  2. Pool resources to create Centers of Excellence, using physical or virtual locations. You made this recommendation in November 2011, and included it in your original High Priority List. Creating regional centers for research and treatment has been recommended by this Committee many times, and I believe these centers are an essential part of any plan to make progress against ME/CFS.
  3. NIH should issue a $7-10 million RFA for outcomes measures, and biomarker discovery and validation. You made this recommendation in October 2012. An RFA with set aside funding to attract a greater number of proposals is a critical and immediate need to jump start research.
  4. Hold a stakeholders’ workshop to reach a consensus on case definition. You made this recommendation in October 2012. We cannot wait two or more years for the current CDC and NIH case definition processes to unfold. We need immediate action to achieve consensus on the appropriate case definition for this disease so that research, treatment development and patient care all reflect what we have learned since the 1994 Fukuda case definition was published.
  5. Remove the CDC Toolkit for healthcare providers from the CDC website. You made this recommendation in June 2012. Despite CDC’s point-blank refusal to follow this recommendation, I ask that you include it in your High Priority list. The Toolkit does not reflect best clinical practices, and patients experiences show that the information in the Toolkit is misused and can be harmful to patients.

Thank you for your efforts on behalf of people affected by ME/CFS. I hope your High Priority list will reflect what will do the most good to help us.

  1. Andrea
    May 10th, 2013 at 11:22 | #1

    This is great Jennie thank you. I will post it later today for Advocates.

  2. Howard Myles
    May 15th, 2013 at 08:37 | #2

    I would just like to say, please,

    1 Fund ME/CFS research.
    2 Pool resources to create Centres of Excellence.
    3 Use the consultative process to reach a consensus on the case definition.

    Do this not only for Americans but for the world!

    • Jennie Spotila
      May 15th, 2013 at 09:23 | #3

      Yes! I hope you can email this in to CFSAC today!

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