From the front row of the ME/CFS AC Meeting

[Cort]

I adamantly disagree with removing the FDA ex officio! We deserve and need an FDA interface, albeit a much better one. This joker was unwilling to open his FDA Rolodex to help make introductions to his colleagues but he SHOULD be willing to do so. The FDA is to critical to matters of blood safety, drug approval (I realize it's a touchy matter) and approval of tests such a standardized XMRV test which every knows we need to rattle off the things that come to mind. No person can cover that ground but I've had responsibilities to go find answers and points of contacts on behalf of a larger organization in my professional life so why not the ex-officios? I think it's time for an action item list for members with tracked due dates. Goes with the territory does it not?

But what is he supposed to do? He cannot comment publicly on the FDA's assessments of drug trials. (Of which there are only two for CFS). Blood safety is a temporary issue that would better addressed by having someone from the Blood Working Group - which has been done. I have been to every CFSAC meeting for the past five or six years and he is rarely asked questions and he rarely has much to answer. After watching all that I honestly think its a waste of taxpayer money to have him there. Maybe he fulfills some functions with the committees..I don;t know. Was he asked even one question over the two days of the meeting?

 

[Sasha]

But what is he supposed to do? He cannot comment publicly on the FDA's assessments of drug trials. (Of which there are only two for CFS). Blood safety is a temporary issue that would better addressed by having someone from the Blood Working Group - which has been done. I have been to every CFSAC meeting for the past five or six years and he is rarely asked questions and he rarely has much to answer. After watching all that I honestly think its a waste of taxpayer money to have him there. Maybe he fulfills some functions with the committees..I don;t know. Was he asked even one question over the two days of the meeting?

What about gathering info from the CFSAC to feed back to the FDA? Is that a useful role (I'm honestly asking the question, I don't know). If he can't give out info, maybe his role is supposed to be to take it back to the FDA.

 

[BEG]

Here is my response from Dr. Wanda Jones concerning Marc Cavaille:

The CFSAC mailbox is monitored, but not all emails are responded to.

We have received numerous inquiries on this subject and are looking into it.

He wasn't asked a question to my knowledge until the last afternoon during the melee when he was "hammered" by the committee and Dr. Klimas came to his rescue. If you watch any of the webcast, don't miss that part. I've never seen the committee so lively. I remember he told the committee what his duties concerning the CFSAC meeting are but won't repeat it yet because I'm not positive of the wording.

 

[Sasha]

I still haven't received a reply from Dr Wanda Jones about my email about Dr CC, not even an auto-reply like Brown-eyed Girl, but I'm pleased to see that the auto-reply says that they've received "numerous inquiries on this subject"!

I find it very cheering that PWC are now feeling in a sufficiently strong position politically to feel entitled to speak out about this behaviour that appears to have gone unchallenged before. I think that XMRV is giving us a sense of legitimacy and enabling us to network on a scale that hasn't been possible before. Phoenix Rising had maybe 750 members, I think, when I joined it 11 months ago (looking for info on XMRV). Now we've got 3,500 members and lots of individual activism groups seem to be starting up.

It may seem a small thing, trying to get rid of someone who sleeps through a meeting, but actually I can't imagine this behaviour being repeatedly tolerated in any professional setting where a meeting was held in public! I think it is very significant that we now feel that our voices will be heard if we insist on our right to be treated with respect and courtesy - in other words, to be treated like a group of normal people with normal entitlements, not a bunch of outcasts.

 

[Sasha]

[Deleted a duplicate post here]

 

[Otis]

Here is my response from Dr. Wanda Jones concerning Marc Cavaille:

He wasn't asked a question to my knowledge until the last afternoon during the melee when he was "hammered" by the committee and Dr. Klimas came to his rescue. If you watch any of the webcast, don't miss that part. I've never seen the committee so lively. I remember he told the committee what his duties concerning the CFSAC meeting are but won't repeat it yet because I'm not positive of the wording.

Cort,

This is the scene I referenced. He was asked some questions about not helping the committee make contact with the right FDA colleagues with questions (started out specific to Amipligen and moved to the general) of approval procedures, not specifics. When he referred the committee to go to the FDA website Wanda finally stepped in and basically said "oh don't worry your sleepy head I'll take of it" in her best decisive tone, and then Nancy pulled the whole mess out of the crapper.

Were you awake Cort? Patients CAN sleep! I'm guessing you stepped out, you would have rememberd.

 

[Hope123]

While Dr. CC might not be able to answer direct questions about Ampligen, he is supposed to be CFSAC's guide to the government juggernaut that is the FDA. That's how I see most ex-officio roles: if they can't directly answer a questions for lack of knowledge/ legal reasons, etc., they should at least be willing to connect members to the appropriate parties and/ or serve as a bridge between their department and CFSAC. Government is a huge institution with multiple departments, rules, etc. that may not be easy to navigate; I think Dr. Jones sees her role as getting the right people to present or introduce to CFSAC and she has done a reasonable job. I think she was annoyed at Dr. CC because he was not doing, even superficially, what she had intended for him to do. Note the contrast with say, the ERISA group, which readily acknowledged they might not be the exact section to ask but said they would try to connect CFSAC to the right people.

It should be mentioned that at one of the recent meetings, the past CFSAC chair, Dr. Oleske, publicly thanked Dr. Bell for Dr. Bell's advice to him to get a sleeping test which led to a correct diagnosis.

 

[Sasha]

It's exactly a week since I emailed Dr Wanda Jones about this and I've heard precisely nothing, not even an auto-reply. Maybe it's because I've got an email address that's clearly a UK one and I said in my email that I'm from the UK.

Has anyone received a response, apart from the auto-reply?