FDA Stakeholder Meeting

:Last day to register or comment on the FDA Stakeholder Meeting

Today is the last day for patients to register or provide comments to the FDA Stakeholder Meeting on April 25th/26. This meeting is turning out to be a bigger deal than we knew. Not only will it light a fire under the FDA to get moving on chronic fatigue syndrome but it’s also the first of 20 planned meetings (Patient Focused Drug Development Program)  with disorders that the FDA deems need help with drug development.

That means chronic fatigue syndrome (ME/CFS) going to be in the spotlight and that’s one of the reasons there’s  more going on to prepare for this meeting  (surveys, webinars, trainings) than in any meeting I’ve seen  before.

Last Day to Register to See or View the Meeting

Today is the last day to register to be at the meeting or even to view the meeting by webcast. (No more crashed servers at the FDA :)). Register for the meeting here. 

Last Chance to Comment on the FDA Stakeholders Meeting

Comments don’t just provide a information resource they also provide a powerful indication of how hungry a community is for help.  We’ve gotten more comments since the last announcement and could use more. Follow Bob Miller’s template, below, to easily input your comment today.

There is a limit of 2,000 characters for the comment section on the form or you can upload a document or letter which isn’t limited in length. You need to fill in your name and basic information. Comment using the link below.



Dear FDA Commissioner Hamburg,

I have been ill with ME/CFS for ____years now. There still are no FDA-approved treatments for me and the other One Million Americans suffering daily from ME/CFS. We need a stated path to drug approval for ME/CFS, with special evaluation criteria to fill the profound unmet need and the empty pipeline, just like you announced for treating Alzheimer’s, “FDA to Ease Alzheimer’s Drug approval”.

The FDA Workshop should lead to a proposal including these points:

1. ME/CFS clinicians with the most experience conducting clinical trials in ME/CFS will be consulted to produce a compendium of biological outcome measurements that correlate with patient improvement.
2. Enrichment studies will be acceptable to demonstrate efficacy for approval for ME/CFS, conditioned on selection criteria for use and continued Phase IV studies.
3. FDA request CDC and NIH study the responders to Ampligen, Valcyte, Vistide, Valtrex and other medicinal treatments to learn what works and how to design studies around appropriate subsets (NIH did that with MS drug – daclizumab, and implicated a unique cell in that disease)
4. FDA request NIH to spearhead clinical trials for ME/CFS where the outcome measures are set through collaboration with the most experienced treating clinicians, just like AZT

My ME/CFS symptoms are

(example – put yours here: Susceptible to opportunistic infections(EBV, HSV, HHV-6, CMV, Coxsackie, H. Pylori) cognitive decline(unable to read a newspaper article), inability to concentrate( only one person can speak at a time), bedridden ( I require 20 hrs. of sleep and rest daily) , muscle pain (unable to use legs, arms and back due to increased pain) headaches (severe migraine like), fevers ( low grade), night-sweats)

My abnormal test results include (put yours in place of mine below):

a. low natural killer cell function, which improves when I am treated with Ampligen
b. Low T-cell count
c. High Epstein-Barr virus titers and HHV6 or Active infection
d. Low VO2max
e. Elevated Cytokines

Thirty years is too long for any illness to go without a single FDA-approved treatment. As long as safety is demonstrated, patients must have access to medicines in order to alleviate our tremendous suffering and to advance our scientific understanding of ME/CFS. Who a treatment works for is more important that whether it works for everyone. We need FDA to start somewhere.


FDA Stakeholder Meeting SurveySeveral surveys are underway to help the FDA understand the needs of the ME/CFS Community. The Chu/Jason survey is longer and more comprehensive; the CFIDS Association survey is shorter and a bit easier to handle. If you can please take them both.

  • Chu/Jason FDA Survey – Dr. Lily Chu, a doctor with ME/CFS, teamed up with Leonard Jason and his team to produce a fantastic, statistically relevant and in-depth survey about prescription drug use and needs in chronic fatigue syndrome (ME/CFS). Dr. Chu will present the early results of the survey at the Stakeholder meeting. Please take this survey!
  • CFIDS Association Survey – the CFIDS Association turned the FDA’s questions into their own survey and it’s getting good responses from the community.  Take this survey here .


The CFIDS Association of America has put on two webinars to prepare us for the Stakeholders Meeting.

  • Finding Your Strongest Voice  – Kim McCleary and  Leigh Reynolds on the tie-in between the Patient Focused Drug Development Program we’re kicking off and the Stakeholder Meeting and how to advocate most effectively.
  • Overview of the Drug Development Landscape – Find out how drugs are developed and approved and what the CAA is doing in this area for ME/CFS.


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