CFSAC meeting Oct 3-4, 2012

Andrew

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The Fall CFSAC meeting will be held on October 3-4, 2012 at the Hubert Humphrey Building, Room 800, 200 Independence Ave., Washington, D.C.

Registration and requests for public comment will be handled online, similar to the June 2012 meeting registration process. We will not take requests for registration, public comment, or written testimony via the CFSAC mailbox.
Follow this link: http://www.hhs.gov/advcomcfs/index.html. Look at the right side of the page near the top to see links for registering and testimony. Because this is a public page that changes over time, I hope they leave this on the front page until the meeting is over. I assume they will.
 

Ember

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After the June CFSAC meeting, Sasha posted, “I wonder if patients/supporters giving testimony could coordinate so that there's a unified message....” Those giving testimony in October might want to read “Jerrold Spinhirne's Public Comment for the October 2012 CFSAC Meeting.”
 

Nielk

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I was hoping to speak this time, but I'm feeling so cynical that anything I try to write is unacceptable by my standards. Maybe next time.

Best wishes for those of you to testify.
I understand how you feel Andrew. I spoke a year ago and just don't even know what to add to that. It took so much out of me.
 

Ember

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The FDA will be providing an overview of the drug approval process at this CFSAC meeting. According to Jennie Spotila's summary, two issues need to be addressed, populations and endpoint measurements:
Two issues emerged during the discussion through the comments made by patients on the call. First was the issue of case definition. While FDA insisted that it does not take a position on definition or name, many patients pointed out that case definition shapes research results. It’s been well established that some criteria sweep in people with idiopathic chronic fatigue or depression. In order to evaluate if a drug helps people with ME/CFS, then the case population must be carefully defined. FDA seems to recognize this as an issue, but there was no clarity on what requirements they might make in study design.

The second issue was endpoint measurements: how do we know if a treatment is working? What can be measured in clinical trials to determine effectiveness? In a condition like high blood pressure, it’s clear that the desired endpoint is a lower blood pressure measurement. But in our disease, what can be reliably and quantitatively measured as endpoints? Multiple suggestions were made, including VO2max, natural killer cells, and actimetry data. Debra Waroff offered the “salad” endpoint: whether she is well enough to make a salad. Dr. Kweder seemed to like that measure, as it is a measurement of functional improvement in patients’ lives. Identifying a consensus around endpoints will be a major feature of the 2013 meeting. (emphasis added)
Staci Stevens testified three years ago, “That questionnaires have become the standard of diagnosis for CFS at the CDC shows how little progress they have made in the last 25 years in characterizing this disabling syndrome.” As a possible theme, patients could be demanding that FDA clinical trials use a test/retest protocol to measure PENE in ME-ICC patient cohorts.
 

Ember

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I spoke a year ago and just don't even know what to add to that.
FDA Deputy Director Kweder has put ME/CFS in the same category as cancer and other "serious and live-threatening" conditions. So where are our Rituximab studies?

Drs. Fluge and Mella are using CCC cohorts. The FDA itself points out that "forthcoming FDA guidelines on 'enrichment strategies,' where a subgroup of patients within a diagnostic classification may demonstrate enhanced benefits of a treatment, may be useful to advance treatment of ME/CFS.”
 

Andrew

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I strongly encourage people to testify! You can also submit written comments without speaking, if speaking is too much of an energy drain. For what it's worth, I posted some things I've learned from testimony on my blog.
I'd like to echo this. I also like the suggestions you wrote. I'm going to add a couple that I learned.

1. Last time I used text to speech software to read my speech back ot me. It made it easier to spot problems. It also showed that It was okay to speak faster. I tend to be slow.

2. While practicing I found that improvising just got me into trouble, and made the speech too long. Better to just read it.

Note: Be aware that the submission requirements have changed. Please read them now so you don't miss a deadline.

Also, realize that a lot of the CFSAC members are as frustrated with the system as we are. So speaking is a way to give them encouragement and ammo to carry on.

And FWIW, I did sign up.
 

Ember

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Also, realize that a lot of the CFSAC members are as frustrated with the system as we are. So speaking is a way to give them encouragement and ammo to carry on.
President Obama had never asked Nancy-Ann DeParle to investigate a specific disorder before. Will having her ear make any difference?
 

Andrew

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I lost track of this. Is she the one Obama asked to look into this. If so, it would be great if she was informed. I imagine that all she will do is contact NIH and tell them of Obama's interest. They will send a list of what they are funding now, and tell them they don't have more money. And that will be that. I don't think they are going to tell her they cut CFS funding despite their budget doubling over the past decade.
 

Ember

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I lost track of this.
Here is the closing paragraph from President Obama's letter to Courtney Miller:
I have asked Nancy-Ann to stay in touch with Dr. Collins at the NIH and Dr. Koh at HHS about my interest in their efforts on CFS. And I have asked her to update you from time to time. She reports that you are extremely knowledgeable about developments in the research on CFS, so I hope you will keep in touch with us as well.
People tend to behave differently when they know that questions may be asked.
 

Sasha

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After the June CFSAC meeting, Sasha posted, “I wonder if patients/supporters giving testimony could coordinate so that there's a unified message....” Those giving testimony in October might want to read “Jerrold Spinhirne's Public Comment for the October 2012 CFSAC Meeting.”
I'd completely forgotten I'd said that! But what a great idea... :p

Jerrold's post is too long for me to read but I like his three numbered proposals right at the end.

Personally I think that key points to push are:

  • adopt the ICC definition for research and diagnosis (as Jerrold also suggests)
  • acknowledge that NIH budget cuts and hard times are no reason to continue to underfund ME research - funding for ME should increase enormously to reflect its disease burden on the population and this will require that the large number of other diseases that NIH researches will receive slight funding cuts that will barely affect them in a fairer redistribution of funds
  • call it ME, not CFS (though if that's going to lead to acres of debate, let's forget that one and choose one with a good chance of agreement)
Any more? Maybe someone could set up a poll on the suggestions.

I do think it's important that 20 PWME don't get up at the meeting and ask for 20 different things. I think it would be great if there are a top two or three that almost everyone could agree on and that we could suggest that people mention in their testimony. I think it would be powerful advocacy. A lack of focus risks making us look like there are no serious issues for us to focus on, and we all know that's not the case.
 

jspotila

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In July, I filed a FOIA request to find out who nominated each of the current CFSAC members. I just posted the results on my blog, and I hope you will read the full post and comment there. Here is an excerpt from my post:

I am struck by the distribution of nomination sources: two members (Dr. Vincent and Dr. Corbin) were nominated by the serving ex officio representative from CDC; two members (Dr. Marshall and Dr. Casillas) were nominated by serving voting members of the Committee; four members (Dr. Cook, Mrs. Holderman, Mr. Krafchick, and Dr. Fletcher) were nominated by CFS organizations; two members nominated themselves (Dr. Levine and Dr. Rose); and the last member (Dr. Dimitrikoff) was nominated by a colleague at Harvard. This does not look random to me. It looks more like a score card with careful selection among the different sources. Consider the 2012 appointees: one successful nomination each from CDC, a Committee member, a CFS organization, and a self-nominee.