Next CFSAC Meeting - August 18th & 19th, 2015

[halcyon]

Does anyone know when the CFSAC will be posting videos of the meeting on youtube?

They couldn't say exactly when but they don't put them up immediately. Looking at past meetings it looks like it takes several weeks to over a month.

 

[Izola]

The committee were behaving as though they have all the time in the world to make a decision whereas HHS is likely to be making its decision - if it hasn't already - and will quite possibly roll it out soon. Once they've started that process I can't see them accepting another name until there's a greater evidence base. It's now or never, I'd have thought, for the next few years.

What other disease get battered around on the name for years w/o any NIH /CDC focus on researching the disease? Dam*. iz

 

[jimells]

NIH Director Collins must've watched the movie "Groundhog Day" and decided it would be a good strategy for not helping us. I stumbled across the minutes of the very first CFSAC meeting in Sept 2003. (Prior to that there was a different committee called the "CFSCC")

Let's see how much progress has been made in the last 12 years:

[Donna Dean] welcomed the committee to NIH campus and apologized for barriers that members encountered coming to NIH as a result of post-9/11 security measures.

Access is still difficult. At the recent meeting, it was suggested that attendees needed to allow a half hour for the Grope Squad.

Dr. Anthony Fauci, NIAID Director, met with the Dr. Harold Varmus, Director of NIH, and concluded that CFS was more complex and activities should be relocated from a single NIH institute.

Twelve years later and the program *still* doesn't have a home. Thank you Dr Fauci. It's good to have it in the official records that Fauci was responsible for this. In fact, these minutes describe much interesting history. They are a valuable resource.

Between 1999 and 2000, ... There were several congressional meetings that Dr. Dean and Acting NIH Director, Dr. Ruth Kirschstein, had with many interested congressional members.

So we know that for at least the past 15 years, Congress has been involved, and NIH *still* refuses to be moved.

Defining And Managing Chronic Fatigue Syndrome report ... was subsequently released in October 2001 (AHRQ report number 42). This report essentially found that it was difficult to find treatments to recommend for CFS other than behavioral therapy or exercise treatments.

Sounds just like the recent AHRQ report - or did they just put a new cover on the old report?

In December 2001, program announcement PA-02-34 was published.
In October 2003, the Trans-NIH Working Group will begin drafting an RFA
[NIH] CFS research funding was $7.2 million for FY 2002, $7.5 million for FY 2003, and $7.7 million for FY 2004.
NIH funds 24 individual studies in addition to three Cooperative Research Centers.
CDC is spending approximately $12 million to $13 million annually on CFS, including overhead costs

Actually, this is much worse than Groundhog Day. There is currently no Program Announcement or RFA. The Cooperative Research Centers closed at the end of 2003.

Last year NIH told the CFSAC that there would be no RFA. The CDC budget recommendation (only a recommendation) is zero, and NIH is expected to spend about $5 million. They are feeding us shit sandwiches and telling us it's lobster.

Dr. Hanna noted ...Career Development Awards for research in psychiatric co-morbidities of CFS
Dr. Hanna discussed the mind-body relationship and how stress impacts on the entire system.

I wonder what these "Career Development Awards" are and who got them. I don't recall hearing any psychobabble during the meeting, so maybe we are making a little progress here, although I vaguely recall that Dr Unger still promotes the "mind-body" nonsense, and she is still publishing studies that conclude that "women's complaints" might cause and perpetuate "CFS".

[At the June 2003 workshop] Dr. Nancy Klimas gave a review of all immunologic findings, emphasizing that the studies were done in ways that do not allow meaningful comparisons. She suggested networking and developing a database that does allow comparisons.

NIH has rejected the CFSAC's most recent call for a patient registry and biobank. And once again CFSAC has repeated the recommendation in this week's meeting with slightly different words that they hope will be more palatable to NIH.

[the workshop concluded that] Large hypothesis driven, longitudinal and multi-site studies with standardized measurements, markers, and testing procedures should be encouraged.

It only took ten years, but it looks like this recommendation is finally happening. Hooray!

Dr. Mohagheghpour asked if they have allowed a budget for establishing a sample bank (e.g., blood bank) for future studies based on the results of previous studies. Dr. Hanna said they would try to.

Now they don't even bother to try to appease us with "we'll try to". Now it's just plain ole "No - 'Cause I said so!"

Dr. Reeves noted that CFS .. studies have not found a consistent risk factor associated with CFS for three reasons [including]

• Different case definitions have been applied.

Dr. Reeves then reviewed the 1994 CFS case definition, A published empirical case definition was developed based on the Wichita data ... CDC will also develop an empirical definition based on the Georgia data.

So having determined that different case definitions are problematic, Reeves develops at least two more.

[FDA's] Dr. Cavaillé-Coll then reviewed their FY 2004 action plan. He stated that FDA is committed to providing timely review of IND [investigational new drug] study protocols and study reports for CFS drug therapies. They will continue to work closely with sponsors of CFS drug therapy at all stages of drug development.

Sounds just like the boilerplate we heard this week.

Dr. Bell asked if there were consistent protocols for looking at the end points because one of the problems clinicians experience is that they use different inputs. Dr. Cavaillé-Coll explained that when they work with investigators from companies, they do try to address the issue of clinical endpoints. They try to examine other studies to see what may or may not work.

As far as I know, this issue has still not been resolved. It might be the subject of one of the new recommendations.

HRSA also trains health professionals; Title 8 specifically addresses nursing in communities, and Title 7 addresses all other health professions. The goal is to increase the number and distribution of primary care providers around the country. ... Dr. Robinson referred specifically to the Health Education Centers, noting that this is an area that supports some of the activities CFSAC is trying to accomplish.

Some time ago with the CFSCC, several questions were raised regarding health profession training institutions. HRSA funds training in general medicine, pediatrics, family medicine, and other general areas. Members of the CFS community were asking why there were so many patients having a hard time getting physicians to take this CFS seriously.

Well we all know that physician training has been a complete failure, unless the goal is to make sure we are treated badly. When CFSAC was speculating on continuing medical education this week, I didn't hear the HRSA rep point out that CME for GPs is something they are supposed to be doing.

[HRSA] Activities related to CFS also slowed down due to issues related to 9/11 and the anthrax attack, and Dr. Robinson expressed his commitment to enhance attention in this area.

So it's Osama bin Laden's fault that doctors don't know about our illness. It would almost be comical if it wasn't so pathetic. Almost. I didn't hear this excuse this week, so maybe that's progress?

[Carol Lavrich, Chair, Name Change Workgroup, CFSCC] She stated that a CFSCC name change workgroup was formed in 2000 to examine this important issue.

The Name Change Workgroup would like to ask CFSAC to move forward and complete their work

[much discussion of the name change issue]

The Name Change Workgroup started in 2000, but accomplished little because of the 2 1/2 year gap between the last CFSCC meeting and the first CFSAC meeting. Fifteen years after the workgroup was formed, CFSAC *still* doesn't know what name to use, even in its own recommendations.

 

[leokitten]

I am not 100% certain but I believe the SEP (Special Emphasis Panel) reviews grants submitted for the general ME(cfs) funds whereas applications to other institutes would be reviewed by that institutes review panel (though I believe a different term is used).
In the past few years it seems that the reviewers on the ME(cfs) SEP have been less of the dentist/psych variety.

@leokitten may be able to help clarify/correct re institute grant reviews. (please)

From my understanding there is no general ME/CFS fund, all ME/CFS projects get funded by an IC (i.e. NIH Institute/Center) or the OD (Office of the Director). See here for 2014:

http://report.nih.gov/categorical_s...ARRA=N&DCat=Chronic Fatigue Syndrome (ME/CFS)

 

[jimells]

From my understanding there is no general ME/CFS fund, all ME/CFS projects get funded by an IC (i.e. NIH Institute/Center) or the OD (Office of the Director). See here for 2014:

http://report.nih.gov/categorical_spending_project_listing.aspx?FY=2014&ARRA=N&DCat=Chronic Fatigue Syndrome (ME/CFS)

Yes, which is why CFSAC and advocates have been calling for an RFA for years, since they usually include dedicated funds. The last one was issued about 10 years ago, IIRC

How funding happens is incredibly complicated. There's about a million ways to get any one project funded, if the leadership really wants it to happen - another reason why the constant whining about NIH poverty doesn't hold much water.

 

[Denise]

They couldn't say exactly when but they don't put them up immediately. Looking at past meetings it looks like it takes several weeks to over a month.

The videos are available:
https://www.youtube.com/playlist?list=PLrl7E8KABz1GQ61Y44NmuLJj5j9Xk2MqA
(I was surprised to find them posted so soon after the meeting. Keep in mind the minutes, etc are not yet available. 508 compliance and all that...)

 

[leokitten]

I am not 100% certain but I believe the SEP (Special Emphasis Panel) reviews grants submitted for the general ME(cfs) funds whereas applications to other institutes would be reviewed by that institutes review panel (though I believe a different term is used).
In the past few years it seems that the reviewers on the ME(cfs) SEP have been less of the dentist/psych variety.

@leokitten may be able to help clarify/correct re institute grant reviews. (please)

@Denise to further answer your question I believe @jimells is correct the SEP reviews all ME/CFS grants regardless of funding IC. After SEP there is a second-level review and council decision to work out administrative issues and whether the IC can fund it or not based on the grant ranking percentile.

 

[Nielk]

MEadvocacy.org blog about CFSAC and their own testimonies.

http://www.meadvocacy.org/giving_testimony_to_cfsac_and_a_call_to_do_more

 

[leokitten]

I posted in another thread some info regarding a potential opportunity to get a rituximab trial started here in the U.S.:

http://forums.phoenixrising.me/index.php?posts/637788/

 

[medfeb]

I believe [USER=4373]@jimells is correct the SEP reviews all ME/CFS grants regardless of funding IC. After SEP there is a second-level review and council decision to work out administrative issues and whether the IC can fund it or not based on the grant ranking percentile.[/USER]

Leokitten, I understood that there wasn't a separate pot of money for this disease. But I had heard that an applicant could request that the proposal be reviewed by a different 1st level review group than the CFS SEP. But once that first level of review was done, all grant requests would then be forwarded to the appropriate second-level review and the decision on whether to fund or not at the institute level.

From what you said, it sounds like that is not correct?

Mary

 

[leokitten]

Leokitten, I understood that there wasn't a separate pot of money for this disease. But I had heard that an applicant could request that the proposal be reviewed by a different 1st level review group than the CFS SEP. But once that first level of review was done, all grant requests would then be forwarded to the appropriate second-level review and the decision on whether to fund or not at the institute level.

From what you said, it sounds like that is not correct?

Mary

You are correct there isn't a separate pot of money. I believe we said the same thing, during the second-level review, the "Council" meeting, is when the funding IC decides to fund the grant based on ranking percentile and a number of other factors.

 

[Denise]

For those who are interested

CFSAC Aug 2015 HHS Q&A and recommendations are posted (as of 11 Sept 2015)

(Meeting minutes and presentations not posted yet)

http://www.hhs.gov/advcomcfs/meetings/

http://www.hhs.gov/advcomcfs/recommendations/2015-08-18-19-recommendations.pdf

http://www.hhs.gov/advcomcfs/recommendations/2015-08-18-19-patient-registry-recommendations.html

http://www.hhs.gov/advcomcfs/recomm...19-questions-and-answers-recommendations.html

 

[Denise]

Public comment submitted for the public record* has now been posted:

http://www.hhs.gov/advcomcfs/meetings/presentations/20150818.html




Chronic Fatigue Syndrome Advisory Committee (CFSAC) Presentations for August 18-19, 2015 In-Person Meeting

Public Testimony

August 18-19 2015

• Anonymous
  
• Jennette Burmeister
  
• Starr Hope Ertel
  
• Myron A. Hoffman
  
• Eileen Holderman
  
• Joe Landson
  
• Mathew Lazell-Fairman
  
• Michel Lee
  
• Denise Lopez-Majano
  
• MEadvocacy Advisory Group
  
• James H. Mills
  
• Billie Moore
  
• Matina Nicholson
  
• Melanie Pruitt
  
• Jennie Spotila
  
• Deborah Waroff
  

http://www.hhs.gov/advcomcfs/meetings/presentations/20150818.html




(* for those who don't know – for public comment to go on the public record it must be submitted by the deadline – usually about a week before the CFSAC meeting)

 

[Nielk]

Does anyone have the powerpoint slides from this CSFAC meeting?

 

[Denise]

Does anyone have the powerpoint slides from this CSFAC meeting?

I haven't seen them anywhere... If you do find them, please post a link here.

 

[Denise]

During the August CFSAC meeting session about the “Unresolved Disease Name”


“Dr. Lee said someone else will soon be taking over DFO duties. But a CFSAC meeting may be able to be scheduled before the winter holidays. ...”


The CFSAC roster (as of 28 Dec 2015) still lists Dr. Lee as DFO


The terms of 4 CFSAC members expire in 2016 (Casillas, Paterson Collier, Corbin and Fletcher).


Has there been any news about the new DFO,

about the next meeting,

and

about when the nomination process will begin to replace the 4 departing CFSAC members?