Archive for March, 2014

Connections, study contact info

One of the highlights of (most) meetings is the opportunity for connecting with people. Such was the case with the IACFS/ME conference held last week in San Francisco.

(There have been some excellent summaries of the IACFS/ME conference — among them: http://phoenixrising.me/archives/24323 , http://phoenixrising.me/archives/24390 , http://phoenixrising.me/archives/24452 , http://phoenixrising.me/archives/24522 , http://phoenixrising.me/archives/24553 , and http://quixoticmeblog.blogspot.com/2014/03/detailed-notes-from-all-4-days-of.html .)

Over and over people talked about how they had exchanged emails with this person or that person for years but had never met in person until this meeting.
ME is such a horribly isolating illness. Even caregivers are often isolated.

Therefore being able to meet other advocates in person, being able to exchange ideas with clinicians/researchers, etc. is exciting and invigorating (and exhausting).

Among the people I spoke with was Dr. Jim Baraniuk who has a study that will start soon (he did not say when). He provided the following contact info for it:

Exercise and Brain Scan Study
Purpose: to understand Chronic Fatigue Syndrome (CFS)
Who: Adults (over 18 years old) with and without CFS are invited to participate.

What: Subjects will have magnetic resonance imaging (MRI) brain scans then bicycle exercise tests.
They will stay overnight, then have a 2nd exercise test and MRI the next day.

Where: Clinical Research Unit, Georgetown University, Washington D.C.
Compensation for time and travel will be paid.

Contacts: Telephone 202-687-8231, FAX 202-687-9886

E-mail:cfsresearch@georgetown.edu or baraniuklab@gmail.com
Georgetown University Medical Center (edit *)

When you contact the lab you might ask (among other things) for clarification about the extent of the bicycle exercise testing, the criteria for patient selection, whether or not any cognitive testing will be done as well (if so, at which points during the study). Please share the responses you get and help us make them widely available.

Many of us came away from the IACFS/ME conference with information on numerous studies and avenues of exploration, getting lots of ideas, hearing hints about soon-to-be-published studies and great connections (some new ones, some long-standing ones but first time in-person meetings)…..

This was a real treat and I am deeply grateful to everyone who helped facilitate attendance at the meeting.

 

(*edited  – disclaimer – I have no connection to and accept no responsibility for the study or participation in it. Thanks for the reminder TK.)

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)