Brigitte De Maere - Comment

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 (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 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 5 years are to long .....