Posts Tagged 'committee members'

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?

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

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)

If you want to submit written public comment for the open session of January 27th, 2014 IOM meeting on Diagnostic Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

IOM has said:  It would be most useful if comments are focused on the following question: “What is the most important aspect or information that this committee should consider throughout the course of the study?”

Anyone can submit written comment to the meeting. (No limit on length.) What are you going to tell them?

If you submit by Jan 22nd the committee will get a copy of them before the meeting on Jan 27. Use this email address – mecfsopensession@nas.edu. Comments submitted after Jan 22 will still go to the committee, but possibly not until after the meeting.

All comments go into the public access file.

Additional info: http://iom.edu/Activities/Disease/DiagnosisMyalgicEncephalomyelitisChronicFatigueSyndrome/2014-JAN-27.aspx

After January 27, send written comments to the project email address (mecfs@nas.edu).

Reminder -the Statement of Work for this project – obtained by Ms Spotila – can be seen here: https://dl.dropboxusercontent.com/u/57025850/MECFS%20IOM%20SOW.pdf .

The tentative agenda for the January 27th, 2014 open session of the meeting on Diagnostic Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome.

Info on IOM Panelists

Info on IOM Panelists

As of today we have 16 days (til 23 December 2013) to submit comment on the IOM panelists.

To give everyone info that may help substantiate comment, info on the “unknown” panelists was posted 2 days ago and today info on the “knowns” has been posted on OccupyCFS blog.

http://www.occupycfs.com/2013/12/07/iom-panelists-the-knowns/

“IOM Panelists: The Knowns

December 7th, 2013 Jennie Spotila Leave a comment Go to comments

In this post, we present profiles of the eight members of the Institute of Medicine ME/CFS definition panel who are known to the ME/CFS community in some capacity. Many, but not all, of them are ME/CFS experts in that they work predominantly in that area. You can read about the team who put these profiles together and the methods we used in this previous post.

Important disclaimer: Many of us know one or more of these panelists quite well. They are our doctors, our colleagues, our friends. We strove to be as objective as possible, and applied all the same research methods and questions here as we did for the other panelists.   ….”

Links to previous OccupyCFS posts on this:

http://www.occupycfs.com/2013/12/03/iom-panel-announced/

http://www.occupycfs.com/2013/12/05/iom-panelists-method-to-our-madness/

http://www.occupycfs.com/2013/12/05/iom-panelists-the-unknowns/

Questions —- lots of them

During the development of the proposed DHHS/IOM project, it seems that DHHS did not involve CFSAC members or let them know what was going on. We do not know if ex-officios were involved at all – because the project was progressed without the knowledge of, or input from the ME community.   When advocates contacted some of our clinical and research experts it turns out that they had no idea about the proposed project until the advocates brought it to their attention.

For some time now, DHHS has wanted to use non-experts in the definition process – CFSAC DFO (designated federal officer) Nancy Lee has pushed really hard on that on a number of occasions. Non-experts? –  to define a disease that many non-experts know little if anything about and that many don’t believe is real? Somehow that does not inspire warm and fuzzy feelings of comfort and confidence.

In May 2013, at the CFSAC meeting, Beth Unger of the CDC indicated that she is not certain post-exertional exacerbation (PEM) should be a required symptom of ME. At least one other person on the CFSAC has indicated that they think PEM is optional and should not be a required in a definition of ME.   Yet, ME experts agree that PEM is a cornerstone, a hallmark of this illness. Is a definition that does not include illness hallmarks one that can accurately describe the illness?

DHHS appears to have changed its position on consensus definitions and who they believe to be the most appropriate groups for developing them. The minutes from the CFSAC Oct 2012 meeting indicate that Secretary Sebelius believed that definitions need to come from the medical community:

           “In general, the Federal Government isn’t in the position of telling doctors a case definition. I think a recommendation from CFSAC that the Secretary should tell people to use “X”                   definition will go nowhere because that’s not what we do. This is a clinical decision that has to come from the clinical community. . .

I’ve been in two or three meetings with the Secretary since I’ve been here. One of them was around this: the idea of a case definition, the need for one, and in addition, the need for a different name for the disease. She basically said that this has to be coming from the medical community. CFS Advisory Committee Minutes, October 4, 2012, p. 37, 38.”

Yet now, DHHS wants to develop a consensus clinical diagnostic criteria for ME. (“The Committee will consider the various existing definitions for chronic fatigue syndrome and develop consensus clinical diagnostic criteria for this disorder.” https://www.fbo.gov/index?s=opportunity&mode=form&tab=core&id=7fafc35816ee932dc44d6c319937b366&_cview=1)

We already have the CCC (http://www.cfids-cab.org/cfs-inform/CFS.case.def/carruthers.etal03.pdf) . We already have the ME-ICC (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3427890/) . Creation of another consensus criteria would take significant time. Implementation of the criteria would add time on top of that. Dissemination of educational material would add even more time. And if the creation of another consensus criteria is done by a group that includes lots (or any) non-experts, we will likely be at least five years further on the road to nowhere or backwards.

Why is HHS pursuing any “other mechanisms to accomplish this work” (“HHS will continue to explore mechanisms to accomplish this work.” https://www.fbo.gov/indexs=opportunity&mode=form&tab=core&id=dfb4054e6f31df6d3969feea989825b8&_cview=0 ) instead of using the work of ME experts?

All of this seems a long way off from the CFSAC recommendation of Oct 2012:

CFSAC recommends that you will promptly convene (by 12/31/12 or as soon as possible thereafter) at least one stakeholders’ (Myalgic Encephalomyelitis (ME)/Chronic Fatigue Syndrome (CFS)experts, patients, advocates) workshop  in consultation with CFSAC members to reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS beginning with the 2003 Canadian Consensus  Definition for discussion purposes.” http://www.hhs.gov/advcomcfs/recommendations/10032012.html

DHHS still has not given a response about the allegations made at the May meeting.

And with this secretive DHHS/IOM proposal, DHHS has shattered the little remaining trust many people had in them.

The draft strategic plan for DHHS F2014-2018 was released earlier this week and one sentence in it reads:

Every operating and staff division within the Department is committed to ensuring the efficiency, transparency, accountability, and effectiveness of HHS programs.” http://www.hhs.gov/open/recordsandreports/strategic-plan/goal-4.html

Have we seen evidence of this transparency?

Has DHHS ensured the effectiveness of the CFSAC program by implementing CFSAC recommendations?

Has DHHS demonstrated its accountability to the CFSAC and the ME community by their actions?

Do DHHS actions demonstrate that they care about what we have to say, that they respect and value our input and that of ME experts?

After all, according to the CFSAC charter, the CFSAC is supposed to be made up of experts in ME – experts selected by and appointed by DHHS. (“Of the eleven members, seven shall be biomedical research scientists with demonstrated expertise in biomedical research applicable to 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 CFS.” http://www.hhs.gov/advcomcfs/charter/index.html ) —

To what extent does DHHS engage with the CFSAC and demonstrate that they respect and value the input provided by the CFSAC?

Can we continue to believe that their intentions for us are honorable and truly in our interest?

Or does it seem that nothing that has been said about ME, to DHHS for the past decades has yielded significant positive results for us?

Lots of questions…..