FDA Workshop on Drug Development for CFS and ME

[Sasha]

The FDA workshop is starting at: http://bit.ly/10dhYvm

I didn't register (didn't want to take a place from someone who can concentrate longer than me) and yet I can see it - so thank for posting this link!

 

[Nielk]

I think that anyone can use this link to listen and see the webcam By the way, it is fascinating so far. Patients are speaking about their experiences.

 

[Nielk]

I like the format where it's interactive. Questions are open for the member of the panel and/or all attendees.

 

[Sasha]

Dunno if it's just you and me, Nielk! I just created a thread with a title saying the meeting was now live-streaming and a link to this thread to send people over here.

Here's the agenda again:

http://www.fda.gov/downloads/Drugs/NewsEvents/UCM344665.pdf

We're coming up to where patients will be saying what they think of available treatments, which will be interesting. Bob Miller already spoke from the floor so maybe he'll talk about Ampligen.

 

[Sasha]

I also heard Dr Joan Grobstein (if I've got her name right - she wrote a storming piece I read a while back) and Jennie Spotila.

 

[Nielk]

Mary Schweitzer speaking now.

 

[Sasha]

Mary Schweitzer speaking now.

I heard her - what an awful story.

 

[Sasha]

I didn't catch the name of the speaker after Mary but she was great.

 

[Nielk]

Talking about general types of current treatments available today. This is an interactive discussion.

 

[Nielk]

Apparently Dr. Peterson is there.

 

[Nielk]

I hope more people are listening to this because I find it very interesting and informative. Btw, I'm very impressed by the respectful way this FDA session is being led.

 

[Nielk]

I didn't catch the name of the speaker after Mary but she was great.

Amanda Simpson

 

[Sasha]

I hope more people are listening to this because I find it very interesting and informative. Btw, I'm very impressed by the respectful way this FDA session is being led.

Yes indeed - and sensitively - several of the speakers have become distressed by what they're having to recount and it's being gently handled.

 

[Sasha]

Open public comment session now - final session of the day.

 

[Nielk]

 

[Sasha]

Interesting - speakers now will include Judy Mikovitz, Dr Enlander, Courtney Alexander (Miller), Drs Lapp, Baraniuk, Peterson, Grobstein...

Edit: We crossed but that screenshot is better!

 

[Sushi]

Did Judy speak? I had to leave the room for a minute. If so, what did she say?

Thanks,
Sushi

 

[Nielk]

Did Judy speak? I had to leave the room for a minute. If so, what did she say?

Thanks,
Sushi

Yes she spoke. Something about ME/CFS like MS and Lupus all have immune issues. Also, Rituximab has 30% response.

 

[Sasha]

I liked the guy who wanted our spit!

I thought Dr Lempert made a good point - that Ampligen has been shown to be effective against HHV-6 (?) and that, rather than being assessed by the FDA for its efficacy against ME it should be being assessed as an anti-viral, in which case it could be used for those PWME who have high viral titres. He said that Mary Schweitzer (I think) went from being HHV-6A+ to HHV-6- three times on Ampligen (she had three courses of Ampligen).

At least I think that's what he said! It was all happening so fast in that session that it was leaking out of my memory as fast as it was going in but there were some excellent contributions there.

Can we see tomorrow's live streaming even if we haven't registered, like we could today's?

 

[waiting]

I'm assuming the webcast is being recorded and will be available later? If so, does anyone have the link for that? I caught some of today, missed most....
Thanks!