Leigh P Prim - Comment

docket #FDA-2012-N-0962-0004. Dear FDA Commissioner Hamburg, I 've been ill with ME/CFS for 11 years. There are no FDA-approved treatments for me & over 1 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 & empty pipeline, 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 outcome measures are set through collaboration with the most experienced treating clinicians, as with AZT My ME/CFS symptoms: 1. Brain lesions. 2. Infections: (a) EBV, (b) Chlamydophila Pneumoniae IGG AB, (c) HHV 6, (d) M. Pneumoniae IGG, (e) C. Pneumoniae IGG 3. 20-30% of normal function, severe restriction of "normal" activity: (a) severe memory and cognitive impairment (cannot concentrate, read & comprehend, (b) severe post-exertion PAIN in muscles/connective tissue/tendons if I use them beyond extremely light tasks, (c) sensitivity to light & noise, (d) blurred vision, (e) slurred speech, (f) severe sleep disturbance/non-restorative sleep (without 1 mg. clonozepam before bed, I "cat-nap"). No illness should be allowed to continue on without a single FDA-approved treatment & research