Posts Tagged 'CFSAC'

CFSAC – to be or not to be

ME community members were caught off guard when the proposed 2016 Senate appropriations bill zeroed out CDC funding for CFS research. Several advocates scrambled to address this and their efforts to be heard appear to have paid off.

But scrambling is not something ME advocates can, or should do. Health- and resource- wise we can’t afford to scramble because it damages our health. Strategic, coordinated and planned approaches would enable less intensive expenditure of resources and allow us to take a measured approach to concerns.

To avoid last minute scrambling, here are a few CFSAC-related things advocates might want to work on.

CFSAC VOTING MEMBERS

In 2016 the terms of 4 CFSAC voting members (Casillas, Collier, Corbin and Fletcher) will expire. FOUR (!) new members out of a total of 11 voting members, means that more than one-third of the committee members will be replaced. That’s a large portion of the voting membership.

The HHS vetting and approval process for advisory committee members is quite lengthy, which means that the request for nominations will probably appear soon. Typically there’s about a 30 day window from the published announcement to the submission deadline, so giving thought to this right away, allows time for recruiting highly qualified nominees and allows for the development and submission of nomination packets. (For reference, the most recent notice was September 2013. The process may be different this time.)

Required expertise (stipulated in the CFSAC charter)

Of the eleven members, seven shall be biomedical research scientists with demonstrated expertise in biomedical research applicable to ME/CFS; four shall be individuals with expertise in health care delivery, private health care services or insurers, or voluntary organizations concerned with the problems of individuals with ME/CFS.”

Of the CFSAC members whose terms end in 2016 –

Mary Ann Fletcher is a biomedical researcher,

Adrian Casillas and Lisa Corbin are healthcare professionals,

Rebecca Collier is a nurse associated with insurance (I believe).

Additional considerations

The CFSAC has a lot of work to do and the learning curve for advisory committee members is steep under the best of circumstances.

In order to best serve the community, all committee members should be highly qualified and knowledgeable individuals who are fully engaged with the work of the CFSAC.

Because of the steep learning curve and the important work that the CFSAC needs to do, ALL CFSAC nominees/members should be well versed in the science, history and politics surrounding this neuroimmune disease, so that from their first day on the committee they all work effectively.

Think about which category of charter-stipulated-expertise the nominees meet. (The categories are – biomedical research related to ME/cfs, expertise in healthcare, insurance, voluntary organizations serving people with ME/cfs.)

It might also be worth examining the current roster to see if there are additional gaps in charter-required expertise.

Which qualifications make for the most effective CFSAC members?

Before initiating the nomination process for anyone, remember to verify their willingness to serve. (In past years, nominees have had to submit letters stating their willingness to serve.)

We have no way of knowing which nominees HHS will appoint to the CFSAC, but ensuring that HHS receives nominations of numerous highly qualified individuals, increases the chances that voting members of the CFSAC will be appropriately qualified individuals who, from the start, can work diligently and effectively on matters related to ME.

CFSAC CHARTER

The CFSAC is supposed to be our venue for getting things on the public record.

The CFSAC charter is up for renewal every two years which means that in 2016 the CFSAC charter is up for renewal.

Renewal is not automatic/guaranteed, so it is worth devoting time to the who, what, when, why and where of charters and working towards getting it renewed.

Since ensuring renewal is likely to be a protracted process, it could be helpful for a team of people to share this work.

Additional considerations

Are there charter changes that would be beneficial?

Would it be appropriate to examine the charters of other HHS advisory committees to see if they include language/provisions that would strengthen the CFSAC charter?

Charter designation

Would it be more appropriate if the CFSAC were a Presidential, or statutorily mandated advisory committee as opposed to being a discretionary advisory committee?

If so, who will follow through to make it happen?

Using unified talking points when working on charter-related issues will help ensure that TPTB aren’t confused by differing messages.

ENGAGEMENT

CFSAC meetings take place (at most) twice a year. Is that sufficient to adequately address material from the working groups, other related concerns within HHS and SSA, etc.?

The current DFO has said she does not have sufficient time to act as DFO and do “her other job”. Will the new DFO be wholly devoted to ME matters?

Is the engagement model we have with the CFSAC and HHS satisfactory? Is the level of openness and transparency in communications and actions satisfactory?

Does HHS take this neuroimmune disease into consideration when developing strategies, policies and/or disseminating information?

Do we need someone at HHS (at a prominent level) who can provide continuity between meetings and outside of working group activities and who can ensure that ME concerns are taken into consideration across all HHS activities?

Would it be useful to have someone more engaged with the community and the activities of HHS to progress matters related to ME?

The IOM report used the model of the HIV Czar and recommended a Czar for this disease. Would this improve HHS’ level of engagement regarding this disease?

If the community is not satisfied with our current engagement model with the CFSAC and HHS, what changes would best serve us and how will we ensure that they come about?

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We must be heard

Advocates have the opportunity to submit public comment for the Chronic Fatigue Syndrome Advisory Committee (CFSAC) meetings. However, if the committee members do not have access to public comment, they cannot use it to inform the advice and recommendations provided to the Secretary of Health and Human Services which is the purpose of the committee.

For the June 2014 CFSAC meeting, public comment was not provided to committee members so Denise Lopez-Majano sent the following letter to Dr. Nancy Lee, Designated Federal Official (DFO) of the Chronic Fatigue Syndrome Advisory Committee (CFSAC):

Dear Dr. Lee,

I am writing to request that written comment always be provided to CFSAC members (including ex-officios, non-voting liaisons) along with all meeting materials.

It has come to my attention that written public comment was not included in the June 2014 CFSAC committee member’s binders. During the meeting it was indicated that submitted written comment was only available at the back of the meeting room. This means that the unless public comment was also provided orally, it was not accessible to committee members, nor could it be readily referred to by them at other times.

In order for CFSAC to correctly address (among other things) concerns about quality of life, and development and implementation of programs to inform healthcare professionals (as detailed in the CFSAC charter), CFSAC members must be knowledgeable about and aware of the realities patients, caregivers and others regularly face. Public comment often illustrates points that committee members/agencies and others may not be aware of. Therefore it is vital that CFSAC members have ready access to it because public comment helps CFSAC correctly advise and make recommendations to the Secretary about these and other issues.

In addition, some advocates/patients can only provide written public comment. As a result, if their public comment is not provided to committee members, not only is their voice not heard at all, but there is no opportunity for their input to inform CFSAC about matters that can result in CFSAC advice and recommendations to the Secretary.

Just as presentations made to the CFSAC help inform the committee’s advice and recommendations, so too does the public comment provided by stakeholders, who after all, are among those most knowledgeable about life with this horrid illness.

I urge you to ensure that submitted written comment is provided along with all other materials for each meeting.”

If you would like to send a similar email to Dr. Lee, her email address is: nancy dot lee at hhs dot gov

Bits and pieces

Many thanks to all those who have written to Tell Dr. Collins to Stop P2P

If you have not already done so, fax or email Dr. Francis Collins today and request that he cancel the P2P Workshop.

Details here http://www.occupycfs.com/2014/06/02/tell-dr-collins-to-stop-p2p/

Additional information about P2P:

http://www.occupycfs.com/?s=P2P

A parallel action to contact Congressional officials about P2P will be released shortly.

WEGO Health Twitter chat about advocating for oneself while living with a stigmatized chronic disease. Hosted by Jennie Spotila

Date: Tuesday, June 10th

Time 3-4pm (Eastern time).

Details http://www.occupycfs.com/2014/06/08/twitter-chat/

The next meeting of the Chronic Fatigue Syndrome Advisory Committee (CFSAC)

Monday afternoon (12-5pm Eastern time) June 16th and Tuesday June17th (9am-5pm Eastern time).

The meeting will be live-video streamed at http://www.hhs.gov/live . (Registration to attend in person ends June 12th. Details https://www.federalregister.gov/articles/2014/05/29/2014-12371/meeting-of-the-chronic-fatigue-syndrome-advisory-committee )

READING THIS Exit Stage Right

(http://www.occupycfs.com/2014/03/13/exit-stage-right/) MAKES Ms. LOPEZ-MAJANO’s PUBLIC COMMENT on 11 March 2014 seem even more significant:

“Even before arriving at their first meeting, CFSAC members need to be well versed in the history, politics, science, breadth of illness, and issues of concern to the community, as well as what has transpired since the committee’s current inception in 2003.

They also need to be ready to work. Right away!

During the December 2013 meeting Dr. Kaplan said “The Center of Excellence idea I think is extremely important and one that I think we should be recommending…”

It is disconcerting that Dr. Kaplan seemed quite unaware that Centers of Excellence have been mentioned more than 130 times in 10 years of CFSAC meetings. It seems to me that he is not familiar with the past work of the CFSAC.

If committee members haven’t made the effort to find out what CFSAC has discussed, then I wonder if you are sufficiently involved with and knowledgeable about this illness and the issues surrounding it.

Committee members also need to be actively involved in the committee’s work. This includes during meetings, in working groups etc.

I understand that not everyone will have input on every point of discussion. However, when committee members are not active participants, it seems those members are chair-warmers – or worse yet, just there to pad their resumes.

Most of you don’t have this illness. WE however are seriously impacted by it at all times and very few advocates are healthy enough to work on all that needs to be done to improve our situation. So we need an effective CFSAC to help us.

Since this committee is charged with making recommendations to and advising the Secretary of Health and Human Services, you need to do everything you can to ensure that this committee works efficiently and expeditiously.

Additionally, despite assurances from HHS that CFSAC terms would be staggered, five six [updated 13 March 2014 to include resignation of Jordan Dimitrakoff] committee vacancies will occur between May and July (2014). Any committee comprised of only 11 voting members, will be unable to work expeditiously if new members need time to learn about the committee, the illness, etc.

I urge the Secretary to ensure that every voting member of the CFSAC is well aware of the committee’s work, of issues regarding this illness and of the issues of importance to this community.

I also urge the Secretary to require that the DFO provide appropriate orientation to committee members.

These actions will help ensure that the committee can always work at full-speed to help those affected by this illness that plagues my grandchildren and so many other people.”

 

 

Public comment 11 March 2014

It often feels as though we (patient community) speak a different language than Health and Human Services (HHS) agencies and that this results in ongoing communication problems between us. This is complicated by the ongoing lack of openness and transparency by HHS.

At the FDA meeting on April 25th 2013, (http://www.fda.gov/Drugs/NewsEvents/ucm369563.htm), time was spent querying participants and restating things to make sure listeners understood the intent of the speakers. As a result, in its Voice of the Patient report (http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM368806.pdf), FDA was able to characterize the patient experience in a way that no other government agency has done before.

After that meeting, at least one noted clinician/researcher restructured the questions posed to patients and is looking for additional ways to ensure more accurate understanding of patient experiences, symptoms, etc.

It seems that Dr. Unger has begun to understand how threatened patients feel by the term “malaise”. To laypeople the connotation is “feeling out of sorts”. This means that the phrase “post-exertional malaise” gives very little indication of the intensity, severity and extent of the serious problems that post-exertional malaise produces. How did Dr. Unger begin to understand how seriously and negatively the term “malaise” impacts us? It started during a conversation between advocates and Dr. Unger. During that conversation, there were opportunities to clarify points and answer questions.

During public comment we have the opportunity to provide input but there is no way to know if you have understood what we say. And during CFSAC meetings, we have no way of asking clarifying questions to ensure that we understood what you have said. Simply put, as currently structured, there is no opportunity on our part or yours for clarification to ensure that we understand each other. And given that some agencies do not respond to questions submitted by advocates between meetings, or instead respond by reiterating things we are already well aware of, we have no opportunities outside of CFSAC to get answers.

We endure this illness, minute by minute, week by week, decade by decade and as a result, we have a wealth of knowledge and experience.

If you are truly interested in this illness and in helping us, surely there are questions you have, that we can help provide answers to. But we currently have no way of doing so.

We must find ways to ensure substantive discussion and accurate understanding on everyone’s part.

Matthew Lopez-Majano

 

Goal 4: Increase Efficiency, Transparency, and Accountability of HHS Programs

 

HHS’s Open Government efforts will break new ground in enabling the public to give feedback to HHS programs. HHS can help stakeholders contribute knowledge and experience to help it do jobs better, and HHS can support new kinds of collaborative teamwork that will deliver better results for our citizens.  HHS will move forward toward new strategies, new tools, and a new culture of public participation and collaboration in its affairs. “ http://www.hhs.gov/strategic-plan/goal4.html (emphasis added)

Suggested reading at OccupyCFS

(Lack of) Progress Report

The December 2013 CFS Advisory Committee meeting was controversial before it began, and honestly things only went downhill from there. … Let’s just focus on the lowlights: the tech, the wreck, and the waste.

http://www.occupycfs.com/2013/12/12/lack-of-progress-report/

11 December 2013 Revised agenda for today’s CFSAC webinar

Received from CFSAC at about 10:45am (Eastern time)

Revised Agenda (Eastern Standard Time)

12:00PM  Call to order, Roll Call (including Introduction of new members, Housekeeping, Welcome, Opening remarks)
12:20PM  IOM Report  – Nancy Lee (including ~20min. for committee questions)
12:50PM Agency Updates
1:10PM Public Comments (please limit to 3 min. each)
1:45PM Break
2:00PM Liaison representatives – reports
2:15PM Education and Patient Care subcommittee and CDC website Committee report
2:30PM ME/CFS Researcher and Clinician-Scientist Recruitment Workgroup Report
3:00PM Education for ME/CFS Working Group Report
3:30PM Committee discussion re: working groups and any recommendations
4:55PM Closing remarks
5:00PM Adjourn

The CFSAC support team hopes to schedule another webinar (either 1-day or 2-day, perhaps in February) before the next scheduled face-to-face CFSAC meeting in May or June 2014 that would specifically focus the committee discussions and recommendations about the workgroup efforts.