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Deadline april 26 to effectively save the cfsac!

jspotila

Senior Member
Messages
1,099
Also, in regards to getting more funding, asking for more funding during CFSAC is good to get our requests into the public record but it sounds like who we really need to hit are the Congressional representatives who sit on appropriations committee. The prob with this is that many Congressional reps do not want to interfere with determining priorities in science, for good reasons in some cases.

It's absolutely maddening. CFSAC says go talk to Congress, and Congress says we can't tell NIH what to do. The idea of charging the CFSAC to come up with a strategic plan, though, might be the work around. If the CFSAC has to come up with a plan including budgetary recommendations, it will be harder for NIH to ignore and easier to sell to Congress. Hopefully.
 

justinreilly

Senior Member
Messages
2,498
Location
NYC (& RI)
CFSAC Should Produce Budget Recommendations

It's absolutely maddening. CFSAC says go talk to Congress, and Congress says we can't tell NIH what to do. The idea of charging the CFSAC to come up with a strategic plan, though, might be the work around. If the CFSAC has to come up with a plan including budgetary recommendations, it will be harder for NIH to ignore and easier to sell to Congress. Hopefully.

I agree. CFSAC should currently, on their own, be making recommendations on budget and related matters to the DHHS Secretary. Do they think this is ultra vires- beyond their legal power or mandate? Members of Congress have shown they are very reluctant to 'interfere' in 'technical' matters of agency expertise. CFSAC's, especially with its current heavy emphasis on research scientists, production of budget and related recommendations would be hugely important in allowing Congress to feel more comfortable in directing DHHS.

I didn't know about the membership allocation requirements. I think it's a little heavy on research scientists and insurers and light on patients and clinicians.

I liked CAA's comments. Nice job. One suggestion FWIW- I recognize that it is appropriate to spent the majority of page-space on the charter. But, I feel it's important to put forth our most pressing 'grievances' like increased budget in every communication with government and media, at least en passant.
 

Cort

Phoenix Rising Founder
The agenda for the CFSAC meeting has been posted: http://www.hhs.gov/advcomcfs/meetings/agendas/cfsac20100510_agenda.html

A few very very interesting things:

  • The Assistant Secretary of Health, Dr. Koh, is scheduled to give a welcome message
  • Dr. Elizabeth Unger (temporary head of the CDC's CFS research program) has 30 minutes
  • Dr. Jerry Holmberg has 30 minutes for a blood safety update on XMRV
  • 90 minutes is schedule for review/update of past CFSAC recommendations
  • Only 30 minutes of public comment on the CFSAC charter :Retro mad:
  • Two hours of committee discussion on CFSAC charter and by-laws

Great agenda - they packed alot in there. Dr. Unger will be very interesting.
 

jspotila

Senior Member
Messages
1,099
I agree. CFSAC should currently, on their own, be making recommendations on budget and related matters to the DHHS Secretary. Do they think this is ultra vires- beyond their legal power or mandate?

Yes, I think some members do believe that they can't make budget recommendations, or that it is pointless to do so. I gave testimony in May 2008 highlighting the disparity between research dollars for CFS vs. other illnesses in relation to lost productivity and investment per patient. Several members of the committee approached me after my testimony and said (I'm paraphrasing) "You really need to take those numbers to Congress because the CFSAC does not make budget decisions." Which, of course, completely missed my point which was the CFSAC needs to tell the Secretary that research dollars are not proportional to the burden of CFS on individuals and the economy.

I hope that Dr. Snell will bring strong leadership to his role as Chairman, and I hope that the new members of the CFSAC will be willing to engage on the issues in more meaningful ways.
 

shiso

Senior Member
Messages
159
It's absolutely maddening. CFSAC says go talk to Congress, and Congress says we can't tell NIH what to do. The idea of charging the CFSAC to come up with a strategic plan, though, might be the work around. If the CFSAC has to come up with a plan including budgetary recommendations, it will be harder for NIH to ignore and easier to sell to Congress. Hopefully.

Inspired by Jennie's post a few days ago, here is an excerpt from my written testimony to CFSAC that I submitted on the 26th. Hopefully indeed!

(ETA - I now see that the point made it into the CAA's submission. Yeah!)

2. The CFSAC charter should require a more specific scope of activities in order to improve the implementation rate of the Committee’s recommendations. The CFSAC charter states that the Purpose of CFSAC is to “provide science-based advice and recommendations to the Secretary of Health and Human Services and to the Assistant Secretary for Health on a broad range of issues and topics pertaining to [ME/CFS].”

While the purpose of any federal advisory committee may be to provide “advice and recommendations” to relevant government agencies, the best science-based advice and carefully considered recommendations in the world amount to nothing unless the Committee’s recommendations are ultimately acted upon and implemented by the appropriate government agencies.

To this end, the CFSAC charter should incorporate a more specific scope of activities (either under the Function section or in a new Scope of Activities section) and require the Committee to present its recommendations to the government in a more formal and comprehensive format (specifically, in a single strategic plan to be periodically updated, as discussed below) and require the Committee to more closely monitor of the federal response to ME/CFS.

As an example, the charter of another federal advisory committee governed by the Federal Advisory Committee Act (the same statute that governs the CFSAC), the Interagency Autism Coordinating Committee (“IACC”), sets out the type of more specific scope of activities and mechanisms that would provide more “teeth” to the Committee’s recommendations and which is likely to result in a higher implementation rate by the government of the Committee’s recommendations.

Specifically, the IACC charter states that that Committee “shall” engage in a very specific list of activities, including the development and annual updating of a single strategic plan for autism research including proposed budgetary requirements, and the submitting of the strategic plan to Congress; the development and annual updating of a summary of advances in autism research related to among other issues, the causes, treatment and access to services for autism patients; and the monitoring federal activities with respect to autism and making recommendations to DHHS regarding any appropriate changes to such federal activities. (See IACC charter.)

The CFSAC charter should adopt a similarly concrete scope of activities with respect to ME/CFS, such as requiring the development of a single, periodically updated strategic plan that encompasses the Committee’s advice and recommendations regarding ME/CFS research including proposed budgetary recommendations that would be submitted to Congress, the development and updating of a summary of advances in all aspects of ME/CFS research, and the requiring of more formal monitoring of federal activities with respect to ME/CFS and a mechanism for feedback concerning such federal activities (or lack thereof).
 

shiso

Senior Member
Messages
159
The agenda for the CFSAC meeting has been posted: http://www.hhs.gov/advcomcfs/meetings/agendas/cfsac20100510_agenda.html

A few very very interesting things:

  • The Assistant Secretary of Health, Dr. Koh, is scheduled to give a welcome message
  • Dr. Elizabeth Unger (temporary head of the CDC's CFS research program) has 30 minutes
  • Dr. Jerry Holmberg has 30 minutes for a blood safety update on XMRV
  • 90 minutes is schedule for review/update of past CFSAC recommendations
  • Only 30 minutes of public comment on the CFSAC charter :Retro mad:
  • Two hours of committee discussion on CFSAC charter and by-laws

Now - how do we get this Dr. Koh guy to listen and act?? We could go without the welcome message in exchange for a few hours of his time for a sit-down with a few of the more competent/ outspoken CFSAC members (e.g. Dr Klimas) and read all the public testimony.

Still, good rather than bad that he is showing up.
 

jspotila

Senior Member
Messages
1,099
Now - how do we get this Dr. Koh guy to listen and act?? We could go without the welcome message in exchange for a few hours of his time for a sit-down with a few of the more competent/ outspoken CFSAC members (e.g. Dr Klimas) and read all the public testimony.

Still, good rather than bad that he is showing up.

The last time the Assistant Secretary attended a CFSAC meeting was in 2006 (I think). Dr. John Agwunobi admitted at that time that the committee had not gotten the attention it probably deserved from DHHS. Within a few months, he had left DHHS and that was the last we saw of the Assistant Secretary!! And I agree that it would be more productive for Dr. Koh to actually pay attention to the committee's recommendations!
 

shiso

Senior Member
Messages
159
Dr. Koh

http://www.youtube.com/watch?v=naC717ZrBLA

Looks like Dr. Koh (the Assistant Secretary of Health that is listed as the decision maker for CFSAC) is a relative newcomer to his role who seems like a competent and ambitious person eager to do a good job.

In this clip, he says he has oversight over 9 presidential and secretarial federal advisory committees - 1 of which is presumably CFSAC.

Maybe for the next meeting, we should look more closely at the other 8 other advisory committees he oversees and make useful comparisons (as apples to apples as possible) in areas like budget, power to offer budgetary recommendations, power to submit recommendations to Congress, number of seats allocated to NIH officials, etc.
 

jspotila

Senior Member
Messages
1,099
http://www.youtube.com/watch?v=naC717ZrBLA

Looks like Dr. Koh (the Assistant Secretary of Health that is listed as the decision maker for CFSAC) is a relative newcomer to his role who seems like a competent and ambitious person eager to do a good job.

In this clip, he says he has oversight over 9 presidential and secretarial federal advisory committees - 1 of which is presumably CFSAC.

Maybe for the next meeting, we should look more closely at the other 8 other advisory committees he oversees and make useful comparisons (as apples to apples as possible) in areas like budget, power to offer budgetary recommendations, power to submit recommendations to Congress, number of seats allocated to NIH officials, etc.

This is a great idea!
 

jspotila

Senior Member
Messages
1,099
New Members

The new members of the CFSAC have been posted: http://www.hhs.gov/advcomcfs/roster/index.html

Dane B. Cook, PhD
Madison, WI
Term: 05/10/10 to 05/10/14

Eileen Holderman
Galveston, TX
Term: 05/10/10 to 05/10/14

Michael Houghton, PhD
Danville, CA
Term: 05/10/10 to 05/10/14

Susan M. Levine, MD
New York, NY
Term: 05/10/10 to 05/10/14

Gailen Marshall Jr., MD, PhD
Jackson, MS
Term: 05/10/10 to 05/10/14
 

jspotila

Senior Member
Messages
1,099
Bio on New Members?

Does anyone have bio info on the new CFSAC members? Two were CFIDS Association nominees; I've copied the bio summaries below. I know Dr. Levine is a CFS clinician in New York City. Gailen Marshall appears to have done work on the role of EBV in CFS. And Eileen Holderman is/was a trustee of the NJ CFS Association. Can anyone add to this info?

Dane Cook, PhD: Dr. Cook is an assistant professor of kinesiology in the department of
education at University of Wisconsin. His recent work has focused on using functional
magnetic resonance imaging (fMRI) to understand central nervous system mechanisms of
pain and fatigue in patients with fibromyalgia (FM) and chronic fatigue syndrome (CFS).
Results from these investigations have demonstrated that CFS patients require greater
utilization of brain regions involved in working memory to accurately complete a cognitive
task. These studies have provided some of the first objective evidence in support of the perceptual experiences in these patients. Dr. Cook was honored with the IACFS/ME Junior
Investigator Award in 2003. He has demonstrated expertise in biomedical research.

Michael Houghton, PhD:
In 1989 Dr. Houghton and his colleagues at Chiron were the first
to identify the hepatitis C virus (HCV) in collaboration with CDC. Their discovery led to a
series of HCV tests that are now used globally to screen the blood supply to prevent
infection. Their work also led to the identification of important new anti-HCV drug targets. For
this work, Dr. Houghton received the Albert Lasker Prize in 2000 as well as numerous other
awards from various countries and organizations throughout the world. He has published
more than 200 articles in the fields of gene regulation, human beta interferon and hepatitis C
and D viruses. In February 2007 he joined Epiphany Biosciences as its chief scientific officer.
Dr. Houghton has demonstrated expertise in biomedical research.
 

Dolphin

Senior Member
Messages
17,567
And I agree with Jerry that anything Tom Kindlon writes is always helpful. We all owe a lot to Tom. If you haven't signed his petition against the Reeves definition please SIGN IT! Here's the link:
http://www.ipetitions.com/petition/empirical_defn_and_cfs_research/
Belated thanks, The Phantom.
I'm afraid I didn't get to submit anything this time around mainly because I was very busy with a deadline.
But I do have a letter accepted for publication which is challenging the CDC!

Well done to everyone who wrote in. I imagine the posters in this thread will make up a good percentage of the submissions they get.
 

Dolphin

Senior Member
Messages
17,567
Hi Jerry,

Well done one your submission. Impressive to see references.
The lack of specificity in defining CFS has allowed psychiatrists in the UK, with no special expertise in neuro-immune diseases, to claim their anachronistic theories of CFS are supported by science. A research cohort can be deliberately selected in which very few subjects actually have any physical disease. A study on this cohort then finds CFS has psychosocial causes and that behavioral treatments are appropriate. The lack of a rigorous case definition by the CDC, which has a worldwide influence, makes this possible.

The most common behavioral treatment offered is graded exercise therapy (GET), usually combined with a form of cognitive behavioral therapy (CBT) that encourages patients to overcome their illness beliefs. If CBT/GET were a drug, it would not be found to be safe or effective for ME/CFS by the FDA. Yet, the CDC links on its website a paternalistic GET pamphlet by St. Bartholomews Hospital, London which states,

"You may be worried that any increase in exercise or physical activity could make your condition worse. Be reassured - research has shown that a guided, gradual exercise programme can
help people who suffer from CFS/ME without causing ill effects."


The research referred to would not meet CDC standards so why should the CDC legitimize it? CBT/GET, in fact, has great potential for harming ME/CFS patients. The risks involved simply do not justify anyone recommending it for ME/CFS. The necessary activities of daily life are already more than many patients can safely handle. I believe if I had been properly diagnosed with ME/CFS in 1996 and warned against the possibility of causing serious damage by continuing to exercise, I would not be as severely disabled today.

I hope under new leadership the CDCs CFS program will begin to correct the tragic mistakes of its past. There needs to be a reemphasis on the pathogenic theory of disease and alterations in the immune system. The CDC should carefully review the information on its Chronic Fatigue Syndrome website. Research using the empirical definition should be removed or clearly marked that the empirical definition was used. Links to the inappropriate UK NICE guidelines should be removed. Patients and doctors should be warned not only to avoid the push-crash cycle but that over-exertion of any type, including graded exercise, runs the risk of causing serious harm.
(my bold)
Could you or anyone point me to that link on the CDC website. I want to save it. I am interested in this area of the safety of GET and have had one letter published on the issue of harm http://jrm.medicaljournals.se/article/pdf/10.2340/16501977-0493 (in response to a Peter White article). I also responded to a letter of his in the ME Association magazine. I think this is the weak point as they keep confusing the issue that reports of harm are relevant even if they don't take place in randomised controlled trials (that is why many countries have schemes where adverse reactions to treatments can be reported).
 

Kati

Patient in training
Messages
5,497
I would like to congratulate everyone that managed to send a testimony. All of them have been read and I thought they were fabulous.
 

justinreilly

Senior Member
Messages
2,498
Location
NYC (& RI)
Kati-

Great letter. An adequate response to the ME pandemic is more urgent now than ever; thanks for reminding CFSAC and HHS of that urgency; and also for telling your story!

Hi Tom,

The link to the St. Bart's GET pamphlet is on the CDC's Toolkit: Fact Sheets for CFS page under Managing Activity.

http://www.cdc.gov/cfs/toolkit.htm

Jerry- Wow, that's outrageous. Thanks for letting us and CFSAC know!
 

sarahg

Admin Assistant
Messages
276
Location
Pennsylvania
Great job, Sarahg! One minor correction is that Reeves is not gone from CDC, just from the CFS research program at CDC.

HaHa...yep. That was one of several typos I found right after hitting "send". I should probably stop myself from reading things AFTER I send them.


Also, all these letters are really great. Hopefully enough to prove this committee is still relevant and still sorely needed. Great job everybody!
 

jspotila

Senior Member
Messages
1,099
HaHa...yep. That was one of several typos I found right after hitting "send". I should probably stop myself from reading things AFTER I send them.

I try not to read things after I've sent them on because I could edit until I was blue in the face (or passed out in bed, one of the two)!


Also, all these letters are really great. Hopefully enough to prove this committee is still relevant and still sorely needed. Great job everybody!

Absolutely! I am really looking forward to watching the meeting next week, and seeing what comes out of the committee's recommendations.