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FDA Now Accepting Video Testimonies From CFS/ME Patients

  [ 8 votes ]   [ Discuss This Article ]
www.ProHealth.com • April 25, 2013


On April 25-26, 2013, the United States Food and Drug Administration (FDA) is holding a public workshop in Bethesda, MD to discuss the development of safe and effective drug therapies for CFS and ME. The panel will hear presentations and comments from CFS/ME physicians, researchers, and patients. Jennie Spotila, founder of Occupy CFS, and Robert Miller, a long-time patient advocate for Ampligen, will both be attending. 

Given the fact that so many patients with CFS/ME are too ill to travel, the comment docket will be just as important as live testimony. The information submitted through comments will also help inform FDA's internal review processes. For example, if they hear from patients that VO2max exercise testing is the best way to measure activity intolerance, they are more likely to consider such testing as a good progress measurement in a clinical trial. If they hear that cognitive problems are our biggest difficulty, they may be more likely to focus on that as a good endpoint in a clinical trial. So, the docket – whether written or video comments – will be an essential part of their preparation of their report. FDA is keeping the docket open until August 2nd to allow people to comment on issues that either arise in the meeting or were not covered on April 25th and 26th.

Video testimony is especially important because without it, the FDA will not have the opportunity to see the sickest patients. It's very powerful to see a pediatric patient confined to bed, or a patient who cannot sit up because of orthostatic intolerance. Those patients need to have a chance to be seen by FDA, and to make their voices heard. The only way to do that is video.

FDA will accept video comment through the docket in the form of links to YouTube videos. The docket will remain open until August 2nd, and FDA is asking people to file comments answering the questions posed in the meeting notice.  You can submit written comment (2,000 character limit), attach a Word or PDF document, or include a link to a YouTube video.

It is not difficult to upload a video onto YouTube. Click HERE to watch a short, informative video of instructions. Written comments can be submitted HERE.

This is a great opportunity for patients to speak directly to FDA and to influence federal funding for research on treatments! Let's make our voices heard!




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