Chronic Fatigue Syndrome Advisory Committee (CFSAC) Meeting, Day 1, June 13, 2012. 9am to 10:00am.

By Adem Lewis / in , , , , , , , , /

Dr. Gailen Marshall:
Good morning, everyone. My name is Gailen Marshall. I’m from the University of
Mississippi Medical Center. I’m the new chair of the Chronic Fatigue Syndrome Advisory Committee. It’s my pleasure to welcome you
here on behalf of my colleagues. And we have a very full
agenda for the next two days. We’re going to start out with
what I think is the best part of the agenda — some comments
from our benefactor, our
champion, Dr. Howard Koh, who is the
assistant secretary for health. And as you with find out if
you do not — have not had the privilege of hearing him before
or speaking with him, you’ll never find a stronger advocate
for this illness than Dr. Koh. So, please. Dr. Howard Koh: Dr. Marshall,
thank you so much for the kind introduction, and thank you also
for stepping up and now serving as our new chair for this very
important advisory committee. I know that you have been a
member here and also have a lifetime commitment to
research on this disease and caring for patients with CFS. In fact, just to brag about
Dr. Marshall for a minute, he’s professor of medicine and
pediatrics at the University of Mississippi Medical Center. He’s spent approximately
16 years providing care for patients with CFS. He’s published numerous
peer-reviewed articles and book chapters on a range of topics
in allergy, immunology and infectious disease. And he also currently serves as
editor-in-chief of the Annals of Allergy, Asthma and Immunology; so he’s an
outstanding colleague, an outstanding
professor and researcher, and we’re absolutely delighted that
he’s our new chairman, so a round of applause
for Dr. Marshall. [applause] And it’s always
my pleasure to come to this advisory committee because we
have such important work to do. This is such a critical
area for public health. There are many patients
suffering from this condition. And we need to do as much as
possible to coordinate research, education, patient care, and try
to improve the quality of life for those who are affected
by this condition around this country. So we are looking for this
advisory committee to continue to do that work, and we are
very, very grateful to the committee members who are here,
who are giving us your time to make a difference
for public health. Before I go any either, let’s —
can we just go around the room and do self-intros so everybody
knows who each other is? Dr. Lee, do you want to start? Dr. Nancy Lee: Sure. And I think we need to press
our buttons, Eric [phonetic], when you speak,
because we have just for — about now we have — our audio
— we have a call-in number that people can call in and listen
on the phone; we’re also live-streaming this meeting. So we always need to speak into
this mic, so don’t forget to hit the little button. And so I’m Nancy Lee. I’m the deputy assistant
secretary for women’s health here in the office of the
assistant secretary of health. Dr. Koh is my boss. And I’m also the designated
federal official for this committee. Dr. Martha
Bond: Goo morning. I’m Marty Bond, senior public
health advisor, and an alternate DFO. Glad to be here. Dr. Susan
Maier: Good morning. My name is Susan Maier, and
I’m here from the National Institutes of Health. Amanda Wolfe: Good morning. I’m Amanda Wolfe [phonetic]:, and I’m here with the Social Security
Administration today. Dr. Alaine Perry: Alaine
Perry with the Centers for Medicare and Medicaid Services. Dr. Dane Cook: Dane Cook, associate professor of kinesiology at University
of Wisconsin-Madison. Dr. Susan Levine: Susan
Levine, private practice, New York City. Dr. Ann Vincent: Dr. Ann
Vincent from General Internal Medicine, Mayo Clinic. Dr. Jacqueline Rose: Dr. Jacqueline Rose, patient sufferer. Steven Krafchick: Steve
Krafchick, attorney in Seattle who represents people with
Chronic Fatigue Syndrome. Dr. Adrian Casillas: I’m
Adrian Casillas, associate professor in section of allergy
and immunology at Louisiana State University Health
Sciences in Shreveport. Dr. Mary Ann Fletcher:
I’m Mary Ann Fletcher. I’m a professor of microbiology,
immunology and medicine and psychology at the University
of Miami in Miami, Florida. Dr. Jordan Dimitrakoff:
Jordan Dimitrakoff of Boston, Massachusetts. Eileen Holderman: Eileen
Holderman, patient rep. Thanks, Jordan. [laughter] Dr. Beth Collins Sharp: Good
morning, I’m Beth Collins Sharp from the Agency for
Healthcare Research Quality. Dr. Theresa Michele: Hello, I’m Terri Michele, representing FDA. Dr. Ermias Belay: Good
morning, I’m Ermias, Belay, and I’m from the Centers for
Disease Control and Prevention. Dr. Howard Koh: Okay, thank
you and welcome, everyone, again. Let me start also by thanking
our tremendous colleagues at the Office of Women’s Health,
Dr. Nancy Lee and Marty Bond. Dr. Lee is still a relatively
new director of our women’s health office. And in her opening year here she
has spent a tremendous amount of time on this area and
this advisory committee. And one issue that came up
immediately was how to make sure that the community around the
country who was committed to these issues had access to
the information going on here
and the discussion — the valuable
discussion that goes on here at every meeting. And we wanted to do that
in a way that was open and transparent and brought in
as many people as possible. And then in these difficult
budget times, we wanted to do that — do this in a way that
had the lowest cost possible. And after much exploration,
Dr. Lee and Ms. Bond discovered this live-video broadcast team. We feel like we’re doing this
committee in a TV studio today. We have, I think,
three cameras here. But this is the secretary’s
communications team and they’re bringing you this advisory
committee proceedings live around the country. So we’re very, very grateful to
you, Nancy, and to you, Marty, for making that happen and a
round of applause for the two of them. [applause] So that alone is an achievement
and we’re very, very grateful to that and we want to continue
the conversation with all of
you. And then before we go further in
the remarks, I want to welcome not only the new chair,
Dr. Marshall, but three new members. And we’re delighted at the
caliber of our members because we try to bring in the
highest-level colleagues to make a difference on this committee. So you heard that Dr. Adrian
Casillas is program director, allergy and immunology section,
Louisiana State University Health Sciences Center,
Shreveport, Louisiana. We’re delighted
to have him here. We also have, as you heard,
Dr. Jacqueline Rose, and she is a fulltime staff,
board-certified anesthesiologist at the VA Medical Center in
Washington, D.C. She’s also a member of the CFIDS Association,
has an extended interest in public health and is a person
who studies with myalgia and encephalopathy. And then our third new member
is Dr. Mary Ann Fletcher, who is director of the E.A. Papper Laboratory of Clinical
Immunology, the University of Miami Miller School of
Medicine in Miami, Florida. She too has participated in
research projects in CFS as well as vital areas such as HIV,
AIDS and Gulf War illness. So we continue to have an
outstanding advisory committee and we want to thank the new
and the returning members. I wonder if, at this moment, the
new members can step forward and I have the honor
of swearing you in. And we’re going to be capturing
this for posterity with Kathy [phonetic]
coming up with our camera. So can the new members step
forward and we’ll swear you in? Dr. Howard Koh: So, a round of applause again for our new members. [applause] We always
love doing that. Okay, let me — let me just
make some comments about what’s happened since the last meeting
and the progress we continue to promote in this very important
and very challenging area. First of all, you know that this
advisory committee has a number of subcommittees that are
addressing integration of efforts on research, education
and improving quality of life. And so since the last meeting,
I understand the subcommittee on research has contributed to a
very important published article entitled, “Minimum Data Elements
for Research Reports on CFS.” We’re trying to integrate
research efforts and make them more whole, if you will, and
make them more uniform for researchers who are trying to
advance efforts in this very vital area. So this article on minimum data
elements will help us reach that goal. And then also since the last
committee gathering, the Subcommittee on Patient
Education and Quality of Life has helped to identify the topic
for today’s discussion that is on childhood CFS, so I want
to thank that subcommittee for identifying that critical area
and bringing some key speakers here today to discuss this area. That same subcommittee is also
working closely with CDC, the Centers for Disease Control and
Prevention, on the content of the CDC’s chronic
fatigue syndrome website. So we want to thank the
subcommittees for pushing those efforts forward and also for
continuing to prioritize the recommendations that are coming
out of this advisory committee. Let me also tell you what’s
happening at the department because we understand that we
need to integrate and mobilize efforts in this area
better than before. I did mention at the last
meeting that about a year ago we and the secretary convened a
cross-department meeting on chronic fatigue syndrome to
consider how the department could best address the needs
of patients and the community around the country. We all agreed that we needed to
improve communication within the department and collaboration
within the department on this area. So an ad hoc work group has been
established and has met twice and will continue to meet. And I really want to thank,
again, Dr. Nancy Lee, who has chaired these efforts. Getting all these leaders in the
department to come to the same table and establish a common
agenda is never easy but these two meetings have been
productive and we’re going to have more until we have more
deliverables to present to you. Just to stress that these are
agencies that include NIH, CDC, the Agency for Healthcare
Research and Quality, AHRQ; Health Resources and Services
Administration, HRSA; the Substance Abuse and Mental
Health Services, SAMHSA; the Centers for Medicare and
Medicaid Services, CMS; FDA; and also the Administration on
Children and Families, ACF. As the assistant secretary, I
have the honor of seeing the broad departmental perspective
on this area and many other public health areas. And I know we make advances when
the whole department is working together as one, so that’s what
this ad hoc work group is trying to do on the CFS area. At these two key meetings under
Dr. Lee’s leadership, we asked each agency to put forward
accomplishments and opportunities for the future
that would begin new efforts and conversations, identify new
activities and try to do the best we can in a very
difficult funding environment. And let me just share some of
the highlights of what have come forward in the two meetings
that Dr. Lee has chaired. First, we continue to have a
lot of attention on the National Institutes of Health, NIH. They have a special emphasis
panel dealing with CFS that’s been established, and this panel
regularly reviews of submitted applications for CFS research. So, that is very important
with respect to coordinating attention to all the submitted
applications to that critical research agency. The CDC has also made available
clinical assessment data for all their researchers involved in
this area and put that forward in their research data center,
so that’s another step forward with respect to integration and
transparency on data discovery, if you will, in this key area. The CDC is also promoting
provider education and finalizing and receiving
accreditation for two CME courses — Continuing Medical
Education courses — on CFS. They are now available to
clinicians via the Internet. We know that provider education
continues to be a very, very important area to reduce stigma
and increase understanding, so that effort by the CDC, we
believe, is a contribution. We have an FDA colleague here
who can tell us more, but the FDA has developed in-house
expertise of this area by education its medical product
reviews and centralizing the review of applications from
medical product developers seeking approval for CFS
treatments; so, again, raising awareness in education at the
highest levels at the FDA. Then, back to the CDC, it’s
complicated its first round of updates to its website. It’s incorporating, very
importantly, the feedback that we have heard from advocates
in making those changes. So we want that dialogue to
continue here and we’re very committed to making that
partnership go forward. Then all together as
a department in these conversations, there have been
preliminary ideas put forward about possibly having a
national webinar on CFS and also potentially establishing
a patient registry. So, those conversations
keep going. We know that everybody is
interested in cutting-edge research in this critical area,
and I’m sure that everybody knows that there’s a critical
study that’s being finalized now, led by Columbia
University investigators. The results of this study are
being finalized as we speak. One very valuable outcome of
that effort is that an important and unprecedented repository of
blood samples has been collected by Dr. Ian Lipkin and
his co-investigators. These are samples
from individuals with well-characterized disease. And in my discussions with NIH
and the top leaders there, they stress that having this new
repository of blood samples will be of great value for
future potential studies. So, we are awaiting the results
of that study soon and hope to share that with you in
the very near future. And then we have accomplishments
from Dr. Lee’s office on women’s health. She has posted listservs on the
CFSAC website related to OWH, and hopefully the information
on that website will help subscribers receive information
about upcoming meetings, call attention to this live web
streaming capacity that we’ve just announced, and also share
other cutting-edge information as it goes forward. So, please take a few minutes
to join by going on to that website, and you can find out
more details about it from fliers that are being
distributed at this meeting today. And then I’m very, very pleased
that under Dr. Lee’s leadership, we want to improve communication
with any CFS organizations around the country. As you can see from the agenda
of this advisory committee meeting, a number of those
organizations have been invited today to give
presentations here. And we want to improve dialogue
with, and representation on this, advisory committee of a
number of these organizations. And that’s a process that
Dr. Lee is overseeing. [applause] And, yes
thank you very much. We’ll take any
applause we can get. And as we keep implementing
health reform in this country through the tremendous efforts
of the secretary and so many others at this department,
we want to stress that health reform has an impact
on patients with CFS. We have a preexisting condition
insurance plan program that was launched so that people with
preexisting condition who have not been able to get insurance
for six months of coverage could potentially get coverage by
looking into this option. And we understand that this has
helped at least some people with CFS around the country. And we look forward to telling
you more about that in future meetings. So, these are important advances
but we still have a long way to go, as you know
better than anyone. So we are very pleased to have
this meeting today, have the leadership of Dr. Marshall,
have the expertise of this great committee, and then have this
very important meeting today where we focus on childhood CFS,
hear from all of you and then advocacy organizations, make
sure that these hearings are transparent so that we can
improve the dialogue and see if we can keep making advances
in this critical area. So with this, let me just stop
and see if we have a couple minutes for questions or
comments from the committee. I always stun people in
the silence, you know? [laughter] Steven Krafchick: I’d just
like to say that the ad hoc working committee really is
important and I know that the work is going forward. And it’s important that it does
go forward to coordinate the resources. And I’m encouraged in what you
said about the progress that’s been made. And I know there’s
still a long way to go. Dr. Howard Lee:
Thank you very much. We’ll keep updating you as
we continue to promote that cross-department integration,
which is so critical here. Any other comments or questions? If not, let me go around the
room and just thank each and every one of you on the
committee for being part of this very important meeting. And look forward to the outcomes
here, continued interaction with your new chair. And, again, I want to thank Dr.
Lee and Ms. Bond for putting so many hours into making each
meeting better and trying to address this critical condition
as a united group on behalf of the whole country. So, thank you very, very much. Thank you. [applause] Dr. Gailen Marshall: I want
to add my thanks to Dr. Koh. I think many times we don’t
realize the commitment even the few — relatively few minutes
he’s able to spend with us represents a great commitment. I was told that these — that
the number of meetings with which he deals, are in
the dozens per day. And as someone who deals with a
couple per day and whines about it a lot, I think it gives me
an even better perspective. I want to take just a moment to
let everyone know what I see as the importance of this
committee and where I see this committee going in its efforts. Some critics might suggest that
I’m not really a good person to lead this because I don’t do
active CSF [sic] research at this moment. I’ve done some in the past. I’ve cared for
patients in the past. In Mississippi, chronic
fatigue syndrome is not well-appreciated, unfortunately. And there are no physicians who
identify themselves as expert in the care of chronic fatigue
syndrome in the state of Mississippi of which I’m aware. And I say that based on the fact
that I get regular calls from people asking if there’s anyone
in Mississippi who can care for them, but we are working
extensively trying to get more and more of the primary care
physicians — pediatricians as well as family medicine and
internal medicine — interested in caring for patients who have
complex illnesses such as this. Biomedical research is moving
along, and I have done this for about the last 35 years. And some of the things that
years ago we all dreamed about are coming to pass. The word “translational” when we
put it with “research” now means that we want to take principles
that we learned at the bench and take them to the bedside. A person that I know and respect
suggested the word “reverse translational,” which is going
from the bedside back to the bench. And there are those of
us who love to do that. We go from the bench
to the bedside. We think about
research principles. We go from the
bedside to the bench. We think about our patients. And interestingly enough, there
are three areas in medicine that are sort of coming around. Some of them are nouveau old;
they’ve been around and now they’re back again. And some of them really are new,
and they’ve been given names, and they’re names that you
will here, and they are certain relationships, and I believe
they bear very strong importance to this illness. The first is that area, that
old idea of holistic medicine. Too many times, well-trained —
there’s an arrogance in Western medicine, unfortunately, that
says if we can’t do — give a pill or do a procedure,
it’s not real — number one. Number two; if it is real, it’s
the patient’s problem, not the doctor’s. The holistic approach to care
says that a person has a body, a person has a mind, and a
person has a spirit — some people might call that a soul — and that you must minister to all three of those to properly
care for a patient. That is a Hippocratic principle
I was talked at in the early ’80s when I went
to medical schools. I continue to try to
teach that to my trainees. And while we espouse it,
unfortunately sometimes we talk the talk and we
don’t walk the walk. The next area is integrative
medicine and it’s something that many people turn to, again,
because it uses the argument that any evidence-based approach
to care, whether it’s classical Western medicine, whether
it might be alternative or complimentary procedures, can be
used for the ultimate good care of the patient. And then perhaps the newest one
— and, for us scientists, the sexiest one — is this area
called personalized medicine. And personalized medicine makes
the argument that by a genetic analysis, that you and I are
unique enough and that we can learn profiles about specific
genes that will allow clinicians to select the proper and most
effective therapy for the individual patient. Yet all three of these are
aimed at improving diagnosis and treatment particularly of
complex illness, not many people seem to think that we need a
whole lot of extensive research in medicine on how to take care
of a simple middle ear infection in an infant. I might argue that point, but I
think most people would suggest that’s not a complex illness. On the other hand, illnesses
such as ME/CSF certainly have tremendous complexity. And while these terms are
fairly recently used, they’re a well-appreciated concept in
medicine that we must address. Most diseases are
actually syndromes. We’re coming to understand that. We’re coming to understand that
as similar groups of signs and symptoms can be caused by a
variety of different factors that require distinct therapies. Asthma is a great example;
hypertension’s another; diabetes is another. Cancer is perhaps, to me, the
best example I can think of because I’m old enough to
remember when people thought there were about 3- or 400
different kinds of cancer. Go to any academic oncology
center now and there are three or four hundred different kinds
of cancers if you drill down to some of the subgroups
of which they speak. And their clinical protocols
aimed at very, very specific therapies. We also know that not all
patients have the same symptoms even though they have
the same illness. That’s called
heterogeneity of disease. And we’re beginning to
understand that in diseases that we have thought we knew how
to care for, for many years — hypertension, asthma, cancer
being good examples of that. And then finally we all know
that different patients respond differently to
different treatments. There’s a lot of the word
“different” in there, having to do with the recognition of
the unique nature of each individual human being. ME/CFS is a complex illness that
has similar symptoms in many patients but, still, has a
spectrum of illness in severity and accompanied co-morbidities
and in responses to therapy. This is a fundamental reason for
the lack of accepted diagnostic criteria and effective therapy
that currently exists for patients with this illness. Combining this with the
historically and sometimes current lack of understanding
among clinicians, researchers, payers and the public, ME/CFS
patients are still waiting, still suffering,
still asking for help. Ultimately, the most effective
approach to ME/CFS will involve addressing the whole patient —
body, mind and spirit — using any and all evidence-based
approaches with the understanding that individual
approaches must be paramount for caring for patients
with this illness. As the newly appointed chair of
CFSAC, I pledge to you on behalf of my colleagues that we will
continue to advise the secretary based upon these principles of
scientific evidence, clinical wisdom and moral compassion. And with that… [applause] [end of transcript]

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