CFSAC Day 3 10/14/10

[Hope123]

Marc Cavaille-Cole, of the FDA -- government spin and stone-walling at its finest................................even Dr. Jones had to call him out on it.

 

[George]

Uhoh, Mark's in bigggg trouble. (big grins)

He keeps looking at the clock, (grins) and I'll be surprised if he's back next meeting.

 

[Otis]

What a "jerk".

 

[George]

Well, that was an interesting statement by Dr. Marshall. It looks like he is indicating there are drugs that are going to be pushed into FDA arena shortly.?????

I'd like to know who the so called "experts" are in the FDA in regards to ME/CFS patients.

 

[Hope123]

I think Gailen Marshall is trying to get this across but it might not be clear: basically, he's concerned that current or future drugs that are being looked at would be dismissed (or not easily approved) due to side effects of said drugs if ME/CFS is viewed as a "benign" condition rather than a serious condition by the FDA people involved in approval. (E.g. severe nausea/ hair loss might be acceptable for a cancer drug since the benefit of the drug - e.g. not dying of cancer -- overshadows these side effects vs. the same side effects might not be acceptable for a drug meant to alleviate mild itching)

 

[George]

Nice explanation Hope. Thank you.
I thought part of what the committee might be getting at was the rumor??? that the FDA didn't approve Apligen because they said "They couldn't approve a drug for an illness that doesn't exist". I guess we're not the only ones who heard that rumor???

Nancy has a great point in the fact that our illness has never had clinical trials in regards to use of drugs for sleep, viral loads, cardiac problems. If a drug get's approval from the FDA for use in ME/CFS (I love saying that, grins) then it would go a long way to legitimizing the illness itself. Right now everything we get is more or less off label use. It's approved for use in say sleep but doesn't have the ME/CFS (that's so cool) lable attached to it.

I mean all the sudden Fibro get's a drug and my doctor keeps trying to tell me I have fibro.

 

[Hope123]

Nice explanation Hope. Thank you.
I thought part of what the committee might be getting at was the rumor??? that the FDA didn't approve Apligen because they said "They couldn't approve a drug for an illness that doesn't exist". I guess we're not the only ones who heard that rumor???

Nancy has a great point in the fact that our illness has never had clinical trials in regards to use of drugs for sleep, viral loads, cardiac problems. If a drug get's approval from the FDA for use in ME/CFS (I love saying that, grins) then it would go a long way to legitimizing the illness itself. Right now everything we get is more or less off label use. It's approved for use in say sleep but doesn't have the ME/CFS (that's so cool) use.

Thanks, George. My biggest concern about Ampligen is the lack of safety data; the company always releases info on mainly business (not science) websites about Ampligen's benefits but you never even get a whiff of "no major side effects were seen." or something to that effect. [I know they have a new Ampligen/ heart study out which I haven't read yet. I have a bunch of CFS stuff I have to slowly go through.] And it's hard to crack what's going on since Cavaille-Cole is correct that FDA cannot talk about things if the drugs hasn't been approved. Unfortunately, because Hemispherix is a private company, people who did and did not participate in the study cannot force Hemi to publish their data.

Not so sure if drug release will legitimize this illness as sell more drugs for pharma. True, pharma tends to give more money to consumer adverstising and med education when they have a drug to sell.

 

[ixchelkali]

What's this? Are we getting a new name??

If I followed the discussion correctly (major brain fog), the committee will be referring to it as ME/CFS and will suggest that the various federal agencies involved do likewise.

 

[Cloud]

If I followed the discussion correctly (major brain fog), the committee will be referring to it as ME/CFS and will suggest that the various federal agencies involved do likewise.

That would be so awesome. I wonder what Ms Unger thinks of that idea since it would put the CDC in the hot seat.

 

[George]

I know I love it. ME/CFS, ME/CFS, ME/CFS, ME/CFS, ME/CFS, ME/CFS, ME/CFS, ME/CFS, ME/CFS,!!!!!

I got the impression that the people at CFSAC are the players for the next round and they have more or less decided to just ignore the CDC since the CDC won't play by the rules. Do you get that impression?

 

[Cloud]

I know I love it. ME/CFS, ME/CFS, ME/CFS, ME/CFS, ME/CFS, ME/CFS, ME/CFS, ME/CFS, ME/CFS,!!!!!

I got the impression that the people at CFSAC are the players for the next round and they have more or less decided to just ignore the CDC since the CDC won't play by the rules. Do you get that impression?

I haven't been able to watch any of the live feed....but I would be so happy if this were the case and they (we) succeeded with a name change. It would be celebration time.

 

[mojoey]

There are absolutely no reasons why ampligen should not be approved. Compared to approved drugs for HIV and cancer, it has an amazingly safe profile. Dr. Lapp and Dr. Peterson both say they've never heard of a person getting worse clinically on the drug. Although that's debatable, the fact that two doctors that have been treating patients for over a decade with this drug have the chutzpah to say anything resembling that is the significant part. No drug is benign, let alone one that modulates the immune system and kills certain pathogens in vitro.

 

[glenp]

Response from Dennis Mangan

From: Mangan, Dennis (NIH/OD) [E] (dennis.mangan@nih.gov)
Sent: October 14, 2010 1:34:46 PM



Glenn - going to join the NIH working group to encourage more research. Thank you for your support! Dennis


Dennis Mangan, PhD
Office of Research on Women's Health
OD/NIH/DHHS
301 496-9006
--------------------------
Sent from a wireless device




--------------------------------------------------------------------------------
From: glenp
To: Mangan, Dennis (NIH/OD) [E]
Sent: Thu Oct 14 11:13:03 2010
Subject:


Dear Dr Morgan

That is great that you will be answering emails now

We need funding for people that can find these retroviruses---forget about funding for the other stuff right now -- these retroviruses have to be top priority for us now. What are you going to do about this?

Thank you
glenn

 

[citybug]

If I followed the discussion correctly (major brain fog), the committee will be referring to it as ME/CFS and will suggest that the various federal agencies involved do likewise.

I think they said the NIH is using ME/CFS already. (I think they caught it from WPI).

 

[Andrew]

I haven't watched yet. I'm afraid I'll get upset. But I can say one thing. I emailed Wanda Jones the evening of day 1 and asked to be inserted as a presenter. I got an email the next day offering me a time slot on day three, which I took. I was impressed with how easy they made it.

 

[voner]

i sent this to Dr. Mangan:

Dear Dr Morgan

thank you for deciding to spend time on ME/CFS/etc funding/research, especially the retrovirial research. For me, it has been 15+ years of pain and misery. Hope helps.

thanks for your time and regards,

timv


////////

His reply (within 30 minutes..)

Tim thank you and we appreciate your support! Be well, Dennis

Dennis F. Mangan, Ph.D.
Chair, NIH ME/CFS Working Group
Senior Research Advisor
Office of Research on Women's Health, OD
National Institutes of Health
6707 Democracy Blvd., Suite 400
Bethesda, MD 20892-5484
Tel: 301 496-9006

 

[Cloud]

I think they said the NIH is using ME/CFS already. (I think they caught it from WPI).

That's interesting......I am super curious to see how this unfolds with the CDC since they have spent 2+ decades claiming ME & CFS are not the same disease.


Voner....thanks for sharing the email....That kind of communication will take us far.

 

[Sasha]

Does anyone know if the conference will be posted on YouTube? I can't view the NIH/Granicus version.

 

[Otis]

Sasha,

Someone will probably break it up for Youtube. One other option is to download the MP4 files (audio and video) or MP3 files (audio). It just winds up making for LARGE downloads.

Otis

 

[Sasha]

Thanks Otis - I will live in hope for YouTube!