FDA Workshop on Drug Development for CFS and ME
- Thread starter Ember
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this is a concern about the definition/description, not the coding itself.
The link you linked is an industry link. These industry pages draw from various sources. The official version can be found from the CDC page. I have not read it because it's in a large pdf file. I am not certain whether it is final at this point in time.
And if I understand correctly, this kind of title/description is logistically (not necessarily politically, in our case) easier to change than the coding itself (because the coding is used in all the software by all the hospitals and doctor offices, etc.; this is why we've been using ICD-09-CM for so many years after ICD-10 was published, because it's thought to be a huge hassle to change all the software and retrain everyone). So it's imperative that when there's an opportunity to change the coding, we try for that.
Just to clarify, the thing the Coalition proposed was to change the actual diagnosis code from 780.71 to G93.3. Those 5-6 characters in bold are what the coding committee is responsible for.
While I am also unhappy if the title and description of G93.3 is changed, this is a separate issue which has to be handled in a different venue (not the coding committee).
I have said all of this before, and this is my last post about this topic on this thread. it is OT here.
Thanks, JohnnyD - this is hugely helpful to me. I have a meeting with a specialist next week in the UK trying to get Valcyte for HHV-6 and I'll be taking some of this commentary about treatment of HHV-6 and co-infections with me.
I listened to this yesterday and thought it was a great session. It's really good to be able to read it at leisure.
Just posted another new one-post thread announcing today's live streaming, sending people over to this thread. I put in the title that you can watch without having registered - I wonder if people didn't realise that yesterday.
The agenda looks great, with some heavy hitters on our side.
Less than an hour to go!
There's a colour test card up now and a guy doing a sound check - just to reassure anyone who is wondering if the stream is already OK - it clearly is!
The agenda looks great, with some heavy hitters on our side.
Less than an hour to go!
There's a colour test card up now and a guy doing a sound check - just to reassure anyone who is wondering if the stream is already OK - it clearly is!
Nielk
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That was my thought too.
Nielk
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snowathlete
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who is this guy?
"the patient community has to do it"
Cannot be done by patient community. patients are seriously ill, we have no money. People have started organizations etc. the problem is the illness has so much stigma, the public do not donate, they don't care.
Patients have been trying for decades...
"the patient community has to do it"
Cannot be done by patient community. patients are seriously ill, we have no money. People have started organizations etc. the problem is the illness has so much stigma, the public do not donate, they don't care.
Patients have been trying for decades...
Nielk
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He is talking about data - the need to put data together like patients like me. He says "if you build it, they will come".
Nielk
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...meaning if the data is there, scientists will come.
snowathlete
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he gave lots of examples that went way beyond data though, and he said several times that the patients must do it.
Nielk
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I think that he meant that the patient population needs leadership to organize this and put it together.
Nielk
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Why wasn't Ampligen fast tracked?
At the December AdCom testimony the FDA said (historically) that Hemispherx asked for fast track status 4 times but were turned down because CFS as not a serious or life threatening disease. But you may be asking about under current PDUFA guidelines for accelerated approval?
Nielk
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I am not sure that I understand the difference of when Fast Track or Accelerated Approval really is. What i am hoping is that now that the FDA is looking into ME/CFS as a complex serious disease, they might change their attitude toward the speed of approval of potential drugs.
Very interesting. In the question period just now he said that if you could get 1,000 patients' data, that would be a fantastic resource for scientists but that if you look on Patients Like Me (?), there are only 200 or 300 or something with CFS.
Phoenix Rising has 1,000 regular visitors...
We should be looking into this and seeing what sort of data we can provide and what's needed. I'd like to see leadership from one or more charities, ideally. This is going to need its own thread! The Invest in ME conference is coming up soon - that would be a good place to get it aired.
I love this idea that there are things that are actually within our reach as patients, if we can organise. Fundraising we can't do as well as the healthy parents of sick kids or the still-functional sick (such as people with early cancer) but the things we can do, we should crack on with.
Did anybody get that guy's slides?
Nielk
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They said that all the slides will be posted on the FDA site ..(soon?)
They are two different pathways to approval. In any case, I think the situation is complex between the FDA and Hemispherx -- but I think everyone is hoping that the FDA will change their mind about the speed of approval of potential drugs, especially ampligen since it has a 20 year track record of helping some percentage of patients.