Wednesday, April 24, 2013

Watch FDA's ME/CFS Workshop Live Webcast

The landmark FDA Workshop on Drug Development for ME/CFS starts Thursday afternoon and runs through Friday. This is a BIG DEAL for everyone with ME/CFS, all over the world. It is the first of a series of workshops the FDA has planned for illnesses/medical conditions that have been traditionally overlooked in drug development (yes, CFS is first for once!).

Although a big deal was made of pre-registering for the live webcast, it looks like you might be able to watch it even if you did not register ahead of time. The links for the live webcast are on this page, and this is also where the video archives will be posted after the meeting.

The meeting runs from 1-5 pm on Thursday, April 25, and from 8:30-5 on Friday, April 26. There will be presentations by top ME/CFS experts, as well as several panel discussions including patients. Here is the full meeting agenda. The main patient panel discussions are scheduled for:
  • 1:30 pm Thursday
  • 2:55 pm Thursday
  • 10:25 am Friday
There are also patients involved in other aspects of the meeting.
(Note that all times are Eastern Time)

Also, it is not too late to let YOUR voice be heard! The FDA will be accepting written and/or video testimony until August 2. Just leave your comments or upload a video or Word file at this page. (See the questions below that the FDA is particularly interested in having answered by patients).

So, send in your comments and tune in as much as you can over the next two days, so we can show the FDA how much interest there is! This is a ground-breaking meeting for the ME/CFS world, and you won't want to miss it!

[FDA wants your answers to these questions:

Topic 1: Disease Symptoms and Daily Impacts That Matter Most to Patients
  1. What are the most significant symptoms that you experience resulting from your condition? (Examples may include prolonged exhaustion, confusion, muscle pain, heat or cold intolerance.)
  2. What are the most negative impacts on your daily life that result from your condition and its symptoms? (Examples may include difficulty with specific activities, such as sleeping through the night.)
    1. How does the condition affect your daily life on the best days and worst days?
    2. What changes have you had to make in your life because of your condition?

Topic 2: Patients’ Perspectives on Current Approaches To Treating CFS and ME
  1. What treatments are you currently using to help treat your condition or its symptoms? (Examples may include FDA-approved medicines, over-the- counter products, and other therapies, including non-drug therapies such as activity limitations.)
    1. What specific symptoms do your treatments address?
    2. How has your treatment regimen changed over time and why?
  2. How well does your current treatment regimen treat the most significant symptoms of your disease?
    1. Have these treatments improved your daily life (for example, improving your ability to do specific activities)? Please explain.
    2. How well have these treatments worked for you as your condition has changed over time?
    3. What are the most significant downsides of these treatments (for example, specific side effects)?]


Anonymous said...

Hi Sue. Your link for submitting testimony didn't resolve. But I found the page here:!documentDetail;D=FDA-2012-N-0962-0004


Sue Jackson said...

That's odd, Heather - that's the exact same link I posted! No idea why they sometimes don't work...crazy stuff. Thanks for posting a second link - hopefully, people can get one of them to work!