FDA CFS and ME Teleconference - October 16, 2013

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readyforlife

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When Dr. Enlander was asking where to apply for approval to use Rituximab, I had the feeling that he wanted to know where to apply for FAST TRACK approval. I was under the impression that with the FDA that having me/cfs on the list for FAST TRACK approval that there would be a special area for FAST TRACK
 
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Bob

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Shell

Shell

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Listened to it. There was some good comments and questions. I am glad that it was (yet again) reiterated just how sick we are and how, unlike the other "communities" we are often too sick to fight and thanks to the stupid "CFS" label can't get family and friends to fight for us. After 30+ years the fact that this needed saying (again) is just a little irritating.
 
Nielk

Nielk

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Bob said:
Recording of the FDA teleconference:
www.youtube.com/watch?v=6SfRrwIEAFU

(Seeing as I've posted the video here, I'd better just say that anyone sensitive to swear words might not like a single word written on the YouTube video, as part of the user's profile. It's not part of the recording.)



Video via mrkipping on Twitter.

I came across the video via PANDORA on Twitter:
https://twitter.com/pandoraorg/status/390995837276266496
Click to expand...

Thank you Bob for providing this tape.

The part about panel selection is at 1:08 till 1:12. It is interesting to hear the difficulties with selecting panel members that are knowledgeable about the disease yet have no conflict in interest. By conflict of interest, Dr. Kwieder mentions the fact that if an expert has a lot of experience with clinical research they would be excluded from the panel. They consider that as a conflict of interest.

The work and results of any panel or committee all depends on the specific members on that committee. This is why we had the problem with the non-approval of Ampligen.

How do you think this will translate in the selection of the IOM panel? The IOM states that they do not include anyone on their panel with any bias. Would the fact that someone was involved in research be considered as bias? Would the fact that one called for adopting the CCC now be considered as biased?
 
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Bob

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Nielk said:
How do you think this will translate in the selection of the IOM panel? The IOM states that they do not include anyone on their panel with any bias. Would the fact that someone was involved in research be considered as bias? Would the fact that one called for adopting the CCC now be considered as biased?
Click to expand...


If that's how the IOM panel is to be made up then I expect that most of the ME experts who we are familiar with will be excluded. The 35 signatories who called for the CCC to be adopted might all be excluded, as they all have an interest in the field. But it depends on how strictly the IOM have to interpret 'conflict of interest'.

If they are looking for scientists and other experts who are not directly involved in ME, but who have the ability to assess scientific evidence afresh, then this is where it is all going to go wrong for us. If they don't have guidance as to the nature of ME, and what separates it from chronic fatigue, other than the published literature, then we're in trouble.

If they understand that they need to distinguish separate cohorts, including: chronic fatigue, idiopathic fatigue, CFS and ME (including being able to distinguish mild, moderate and severe ME), then it might lead somewhere useful. My worry is that published research into ME, as opposed to Fukuda CFS, is very scarce. There is research that describes symptoms of ME in detail, but it's swamped by the research into fatigue.

And then there are disagreements about the nature of ME within our community. Should it be based on The Voice of the Patient report, Ramsay, CCC or the ICC etc. Or should it be very inclusive, but with the requirement of post-exertional malaise?

I predict a mess, but if they use The Voice of the Patient report as guidance, and the CCC/ICC, and use a lot of patient input and ME expert input, then it might lead us somewhere useful.
 
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