The big BIG reminder for the ME/CFS community is that the public comment docket on drug development for ME/CFS will close on August 2, 2013. As of this morning, there are only 201 comments! That’s disappointing, given that FDA said it received 750 comments regarding Ampligen. We should not let this opportunity slip by! Remember that you can submit written comments (including attaching a document) or a link to a YouTube video. Take a minute and submit your comment now.
Other FDA new items of interest:
- FDA is hosting a webinar on Draft Guidance to Industry on Developing Drugs for Rheumatoid Arthritis this morning at 11am. The webinar will be archived for later viewing. I’ll be watching to see what I can learn about FDA’s process of developing guidance for industry, since FDA has committed to doing so for ME/CFS.
- FDA is hosting a public meeting for patients, caregivers, and advocates on Demystifying FDA: An Exploration of Drug Development. The meeting is all day on September 10th in Washington, DC and it will be webcast. You do need to register in order to watch the webcast. The agenda has not been posted yet, but this should be a very educational meeting.
- One of the most common pain relievers is acetaminophen, available both by prescription and over the counter. FDA recently cautioned consumers about the dangers of taking too much acetaminophen. Before I found a pain management specialist, I took ibuprofen and acetaminophen over the counter for my pain and probably took too much on occasion since my pain was not being adequately treated. Just because something is OTC does not mean you can take large doses. And given the fact that ME/CFS patients take many drugs off label, we have to be especially careful about dosing and combination.
I think one of the reasons it’s a little more difficult to motivate patient comments for the FDA drug development meeting than it was for Ampligen is that it seems like there’s a less clear “call to action,” so it’s hard to know just what to say.
What would you suggest that people include in their statements? What kind of information does the FDA still need to get? I have to admit having a hard time with this testimony myself… because I don’t want to write yet another “Oh, how I’ve suffered” life story, or just write some generalized nagging about how we need verified, approved drugs and don’t have them. Both those approaches feel redundant at this point. Do you have any suggestions about what would make our public comments most effective at this point?
Great point, Anne!!!
One of the most important things FDA needs to know is the diversity of perspectives on our symptom experiences. For example, cognitive problems emerged as a top problem at the FDA meeting, and my impression was that FDA didn’t realize how significant that is for many patients. And there is such diversity of what we mean by “cognitive problems.”
So I think it would be very helpful to focus on details of the symptoms you find most difficult. Not just “cognitive problems” but examples of memory or language difficulties. Not just “fatigue” or even post-exertional malaise, but when I do the dishes or climb 12 steps, I experience x.
The other important issue is improvement. How do you define significant improvement: driving a car? climbing a flight of stairs? cleaning your house? working 20 hours a week? And how can we measure improvement? A questionnaire that asks the severity of your fatigue in the last seven days is obviously and woefully inadequate. So what matters? the number of steps you take each day? distance you can walk once a week? how long you can use the computer before symptoms worsen?
This is the kind of information FDA needs, and they can only get it from us. I hope you (and others) will be able to share thoughts on this with FDA.
Jennie,
Thanks for this reminder. To be honest with you, I can’t remember if I already submitted my comment to the docket. (ha – proof of cognitive problems?) Is there a way for me to check if I have done this already?
Thanks,
Gabby