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FDA Workshop on Drug Development for CFS and ME

Marco

Grrrrrrr!
Messages
2,386
Location
Near Cognac, France
I left it blank and carried on with no problem. Unless my memory's gone (very possible).

Thanks Sasha

I thought I read somewhere in the preamble that questionnaires with blank fields wouldn't be saved but maybe that doesn't apply to the introductory questions.

I'll give it a go.
 

Desdinova

Senior Member
Messages
276
Location
USA
So who else isn't invited? First I hear Dr. Peterson wasn't invited because they say he only treats with Ampligen. And now Dr Elander wonder what their excuse is for him?
 

Ember

Senior Member
Messages
2,115
ICD-10-CM is not currently valid and is still subject to change.
What is the status of this version of the ICD-10-CM? Does Diagnostic Code G93.3 as shown below reflect the Coalition 4 ME/CFS proposal, submitted to NCHS in July 2011 requesting that CFS be reclassified? Is ME to be removed as a diagnosis and replaced with CFS?
2013 ICD-10-CM Diagnosis Code G93.3
hierarchy2.png


Postviral fatigue syndrome
  • distinctive syndrome characterized by chronic fatigue, mild fever, lymphadenopathy, headache, myalgia, arthralgia, depression, and memory loss; candidate etiologic agents include Epstein-Barr and other herpesviruses.
  • Syndrome thought to be caused by a viral organism resulting in chronic fatigue, fever, pain, sore throat, and, in some cases, depression.
  • A syndrome of unknown etiology. Chronic fatigue syndrome (CFS) is a clinical diagnosis characterized by an unexplained persistent or relapsing chronic fatigue that is of at least six months' duration, is not the result of ongoing exertion, is not substantially alleviated by rest, and results in substantial reduction of previous levels of occupational, educational, social, or personal activities. Common concurrent symptoms of at least six months duration include impairment of memory or concentration, diffuse pain, sore throat, tender lymph nodes, headaches of a new type, pattern, or severity, and nonrestorative sleep. The etiology of CFS may be viral or immunologic. Neurasthenia and fibromyalgia may represent related disorders. Also known as myalgic encephalomyelitis.
  • G93.3 is a specific ICD-10-CM code that can be used to specify a diagnosis.
  • ICD-10-CM officially replaces ICD-9-CM on October 1, 2014, therefore, G93.3 and all ICD-10-CM diagnosis codes should only be used for training or planning purposes until then.
Applicable To
  • Benign myalgic encephalomyelitis
Type 1 Excludes
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  • chronic fatigue syndrome NOS (R53.82
    note.png
    )
The Coalition 4 ME/CFS provides no information, its website having been disabled.
 

snowathlete

Senior Member
Messages
5,374
Location
UK
So who else isn't invited? First I hear Dr. Peterson wasn't invited because they say he only treats with Ampligen. And now Dr Elander wonder what their excuse is for him?
We have an interview with Dr Enlander coming shortly, and In it he says that we should ask the FDA why? as in, why they havent invited him and others. Out of the five clinics involved in the Ampligen trial, the FDA only invited people from two of them. Its nuts.
 

taniaaust1

Senior Member
Messages
13,054
Location
Sth Australia
I can thou understand why the FDA wouldnt want to invite a doctor from ALL five of the clinics involved in Ampligen trial... they probably want a balanced drug focus at this meeting and not for it to be all about just "one" drug. I hope they've invited other ME speicalists who are treating their patients in various ways eg with antivirals etc. Maybe we should be making sure they've done that and with all the focus on Ampligen..that all the other things which are helping some of us dont go ignored.
 

snowathlete

Senior Member
Messages
5,374
Location
UK
I think maybe that's the thinking behind it but its a bit flawed in my opinion. These doctors are not just Ampligen doctors they know a lot about the illness. Some like Enlander are also in the process of researching other drugs too, which is enough of a reason alone i feel, and finally, their Ampligen experience is vital because they have insight into some of the reasons why the trial didn't work and produce good enough data for the FDA.
 

JohnnyD

Senior Member
Messages
206
December 20, 2012 FDA AdCom transcript is now available

http://www.fda.gov/downloads/Adviso...rugs/ArthritisAdvisoryCommittee/UCM345463.pdf

A summary by a HEB yahoo poster (kleinhopper)
------------------
Dec 20th 2012 Adcomm transcript is up

Not sure if this has anything to do with volume and price movement today but I just noticed the transcript from the Adcomm is up. 429 pages of data mining, have at it. I am going to skip to the end to see what what actually said during the votes.

Following are some key quotes on the final vote (this is what I have been waiting for.) I listened to the Adcomm but everything happened so fast at the end that there was less clarity than what is in the transcript The bottom line is that the committee was UNANIMOUS in thinking Ampligen is likely effective in helping at least a sub-group of CFS sufferer

Dr. Hennessy (yes): “I voted yes, which suggests that I'm interested in seeing a flexible regulatory approach to this drug.”

Dr. Komaroff (no): “I think the opportunity with this drug might be substantial, and I certainly would encourage further well-designed and conducted studies.”

Dr Gardner (no): “I would like very much to see work done on the subgroup that would reduce the concern down from perhaps a million people into some appropriate subgroup that would get the benefit that would be worth the risk going forward. So I'm hopeful that the agency and the sponsor will be able to narrow the target.”

Dr Ware (no): “I'm comfortable with the way Dr. D'Agostino has summarized things.”

Dr. Dagostino (no): "when you look at the database, I think it's encouraging that there might be some efficacy."

Dr. Gualtier (no): “While I believe that there's a lot that's encouraging here and there's significant need, I'm hoping that the more careful, well-monitored study takes place, and also careful collaboration between the agency and the sponsor to do that.”
Ms. Perry (yes): “I just think my biggest concern with this vote today is, what is going to happen to those patients who need this drug? I'm disappointed by the vote”

Dr. Buckley (no): “I think -- and I think that's uniform -- that there may be a signal here of a drug that can help patients”

Dr. Russell (no): "I think we should give the sponsor
encouragement to do a very careful, well-monitored study because I think there is a signal here, and it has potential in this disorder."

Dr. Marshall (yes): "I think, as my colleagues have already indicated, there clearly is a signal here. It's probably a subgroup issue. It's not good for everyone. Ten years from now, we can still be parsing and arguing with good studies as to which subgroup it's going to work."

Dr. Unger (no): “there is something there, and I wish the data had been clearer.”

Dr. Rudorfer (yes): “I think that we have enough information in hand to make this drug available now. I think the FDA has it within its power to label it appropriately, for example, not indicated for mild illness.”

Dr. Borish (yes): I primarily just wanted to send a message that I really think there's a signal here that this drug works, and I would love to see the right study being done very quickly
.
 

JohnnyD

Senior Member
Messages
206
It looks like Dr. Peterson is going to participate in the workshop regardless of being invited. :)

============
SIMMARON RESEARCH, INC
Cordially invites you to the following presentation:
Scientifically Redefining CFS/ME By
Dr. Daniel Peterson
Dr. Isabel Barao
Gunnar Gottschalk
Thursday, April 25th, 2013
9 AM - 12 NOON
Marriott-Bethesda, 5151 Pooks Hill Road
No reservation required! Open seating
 

SpecialK82

Ohio, USA
Messages
993
Location
Ohio, USA
It looks like Dr. Peterson is going to participate in the workshop regardless of being invited. :)

============
SIMMARON RESEARCH, INC
Cordially invites you to the following presentation:
Scientifically Redefining CFS/ME By
Dr. Daniel Peterson
Dr. Isabel Barao
Gunnar Gottschalk
Thursday, April 25th, 2013
9 AM - 12 NOON
Marriott-Bethesda, 5151 Pooks Hill Road
No reservation required! Open seating

Actually the FDA workshop begins at 1:00 PM on Thursdsay. So this annoucement is about his own seminar immediately before that. However, because he will be there in town, I'm sure he will at least be at the FDA meeting too.
 

JohnnyD

Senior Member
Messages
206
Correct, he was not invited to present, so he created his own presentation. Perfectly timed and placed (IMO, a three hour presentation by one of the worlds most experienced, scientific and empathetic CFS docs is about right). Good for Peterson.