Welcome and thank you for standing by.
Today's call is being recorded. If you
have any objections you may disconnect
at this time. All participants are in a
listen-only mode until the question and
answer session of today's conference. At
that time you may press star 1 on your
phone to ask a question. I would now like
to turn the conference over to Margo
Warren. You may begin.
Good afternoon, my name is Margo Warren.
I'm from the Office of Communications
and Public Liaison at the National
Institute of Neurological Disorders and
Stroke. On behalf of the NIH I'd like to
welcome you to this afternoon's
teleconference and to thank you for your
interest in participating in this
discussion with us today.  Dr.
Vicky Whittemore, a program director at
NINDS, will introduce the speakers each of
whom will make some remarks after which
we'll open the phone call for your
questions. We will try to make our remarks
brief so that we can answer as many
questions as possible in the time we
have remaining this afternoon. We also
ask that everyone asked only one
question so that we can hear from as many
of you as possible.
Now Dr. Whittemore. Good afternoon and
thank you everyone for joining us this
afternoon. First I have to bring
apologies from Dr. Koroshetz who is
unable to join us today because he's
involved in a BRAIN Initiative meeting
all day today but we will debrief him
after the call and let him know about
the issues and concerns that were raised
and questions that were raised by all of
you in the community. So we're going to
do some brief NIH updates and I will
introduce each of the speakers and then
we have Dr. Elizabeth Unger from the CDC
joining us today as our guest speaker
and then following her presentation we
will open it up for questions from all
of you. So first I would like to
introduce Dr. Andrew Breeden from NINDS
who will give you an update on the NANDS
Council Working Group on MECFS. Dr.
Breeden.
Thanks Dr. Whittemore. So before we
discuss the working
group of council it might be helpful to give
a little bit of background about what an
advisory council is for those who aren't
familiar. Each NIH Institute or Center
has a National Advisory Council that's
made up of scientific and medical
experts who can advise that Institute
director in this case being Dr. Koroshetz
on important policies and procedures. In
the summer of 2019 NINDS formed a
working group of our advisory council
that's focused on how to best advance
MECFS research. The working group is
composed of scientists, clinicians,
representatives from advocacy
organizations and individuals with MECFS.
The working group was charged with three
main things the first being to identify
gaps in current knowledge opportunities
for future action in a series of
potential strategies to pursue for each
gap or opportunity, the second was to
examine how to attract and train a
pipeline of new and early career MECFS
investigators, and finally moving forward
to examine how to enhance ongoing
research collaboration and communication.
The working group held an in-person
meeting and many productive conference
call conference calls over the last year
and issued a request for information
that was open to the public to gather
wider stakeholder input into this
process. So we wanted to announce today
that the responses to this request
for information were posted on the NINDS
website this morning and we will send
out a link to the MECFS listserv for how
to access these responses. This entire
process culminated in a report that's
currently being finalized and will be
presented to the National Advisory
Neurological Disorders and Stroke
Council on September 4th and the report
will also be made public. We'll post this
additionally like the RFI responses on
NINDS website. After the report is
presented the next steps will include
dissemination of the report to the other
NIH institutes offices and centers that
compose the Trans-NIH MECFS Working
Group, which is the body that oversees
extramural MECFS research at NIH and
this group will prioritize these
recommendations and develop a
plan for implementing them. And so we
look forward to keeping in contact about
this and discussing this further after
the report is posted on our website and
presented to the council on September
4th. Great thank you very much Dr. Breeden.
So as he mentioned the public
portion of the NIH council is open and
webcast so we will we can send that
information around or you can find that
if you go to the NINDS website and look
for the NINDS council information. So
next I'd like to introduce Dr. Avi Nath
who will give us an update on the
intramural study. Dr. Nath. Thanks Vicky.
So we continue to make steady progress
in enrollment and studying the MECFS
patients in the intramural program. So
currently for visit 1 we've had a total
of 48 individuals. That includes the
healthy volunteers and the patients and
and then we've had 13 for the second
visit which also includes roughly half
and half the patients and healthy
volunteers. We've had to bring back some
of the patients after visit 1 because
we added a number of additional tests so
so that involves an extra visit but that
is also almost being finished now so we
have another six that are scheduled for
visit 2 and so I think we're doing well
with as far as recruitment is concerned.
And we've collected a lot of data. We
started analyzing some of these things
to make sure that all the tests that we
are doing are ones that we want to take
forward are things that are not going to
reveal much information we should drop
them out and try to see how we can
optimize the number
things that are being done. So that's
where we stand currently. Thanks. Thank
you. So I'd like to now introduce Dr. Joe
Breen from NIAID who is going to give an
update on the collaborative research
centers and the data coordinating Center.
Dr. Breen thank you. I want to give you a
 just a snapshot of some of the
progress the collaborative research
centers of which there are three, one based a
Cornell, one at Jackson labs in
Connecticut, and the third at Columbia in
New York City, have been working now for
two years. And they're actually just
transitioning to their third year of
research and that's the same timeline
for the data management coordinating
Center which is located at RTI in North
Carolina. So we're at an important
junction. I think it's not uncommon that
we don't have peer-reviewed published
results from two years of support but we
would expect that we would start to see
steady progress around this junction and
moving forward as the centers really
had to get started, hire staff in some
cases, and  others actually
recruit patients that they'll have to
use those samples for study. So what I
want to confer is that we do see steady
progress at each of the centers we've
had discussions and programmatic
meetings with each and we we know that
they're preparing manuscripts and we're
encouraged that the level of output that
we expect will become publicly available
as the papers are accepted over the next
three to six months. And the data
management coordinating Center is
actually working well with the other
centers and in particular for the
collaborative projects which were
designed for projects in between the
centers where they can collaborate, share
samples, validate analyses, those projects
are
also underway. They've had year 1 and
year 2 projects and we hope that we'll
see the fruits of those collaborative
projects over the next year as well and
the data is being coordinated and I
think the website the MECFSnet that is
available from the data management
coordinating Center will become
increasingly valuable as this data is
publicly available and can be really put
in one place and we can start to do some
high-level informatics analysis to truly
try and understand what we can as we
combine efforts across these centers. And
hopefully that will broaden as we
increase the partners moving forward. So
we're encouraged and we expect it will
see increased output in terms of
scientific publications and progress and
understanding the basic biology of MECFS
that's going to help us make the best
decisions in the future. Thank you. It's
now my pleasure to introduce my
colleague and friend from the CDC Dr.
Beth Unger who's going to give us an
update on the CDC MECFS activities. Dr.
Unger. Thank you so much Vicky. I really
appreciate the opportunity to
participate in this telebriefing. This
invitation really does reflect our
ongoing interagency communication and
coordination. It's really important that
NIH and CDC work together to address 
MECFS issues and this has made
particularly critical in the absence of
the CFS Advisory Committee. So we've been
working to solve that problem together.
CDC continues to focus on improving our
understanding of MECFS and improving
awareness particularly in the medical
community and are taking steps towards
improving the care of those affected. Our
multi-site clinical assessment of MECFS
study which is
MCAM has now entered a new phase. We've
completed the enrollment and data
delivery on adults with MECFS and the
healthy controls from the seven original
clinical sites. The data from adolescents
with MECFS and children with other
illness and adults with other illnesses
sorry who were enrolled at these clinics
has also been delivered. However because
the enrolling clinics didn't really
serve these additional populations we
needed to find a different way to
supplement our numbers and we are just
now beginning to enroll children and
adolescents with MECFS as well as adults
with other illnesses that can cause some
of the symptoms seen in MECFS such as
rheumatoid arthritis, multiple sclerosis,
and post cancer fatigue. We expect that
this enrollment will continue another
year. While this effort continues we are
beginning the analysis of the original
data that was collected. Our description
of MECFS illness characteristics based
on many but not all of the new common
data elements is being prepared for
publication. The exercise and cognition
datasets have been shared with our
expert collaborators Dane Cook and
Gudrun Lange who will be leading the
analysis and publications of these
findings. The result of the NK cell
function testing on a subset of the MCAM
participants will be ready for
analysis by the end of the year. It plans
for additional publications that will
provide validation of the questionnaires
that we've used for measuring fatigue
and for comparing different approaches
to measuring post exertional malaise. Our
other major epidemiologic study is being
conducted in partnership with CDC
Behavioral Risk Factor Surveillance
Survey known as the BRFSS. The 2019 BRFSS
included an optional MECFS module to ask
patients about whether they had ever
been diagnosed with MECFS by a doctor or
other health care professional,
along with two other follow-up questions.
We don't yet know how many states have
included this module. However we do have
data from the 2014 and 2016 state added
MECFS questions that were very similar.
From the 2014-16 data we learned that
1.6 percent of those who've surveyed had
received a diagnosis of MECFS and 71
percent of those still diagnosed had
MECFS. These figures are very comparable
to those obtained from the Canadian
health survey that was conducted in a
very similar way. The BRFSS will allow
information on persons with MECFS to be
integrated with that collected on other
health conditions and behaviors and
including MECFS in this mainstream
survey also raises awareness about the
condition. States that use the module
would learn how MECFS affects their
residents and we hope that will help
mobilize action. CDC is also raising
awareness about MECFS through
collaborations with professional medical
organizations. Our staff designed a
banner advertisement that appeared on
the website of the Georgia chapter of
the American Academy of Pediatrics. The
ad directed readers to CDC's MECFS
webpage. The Georgia chapter of AAP also
secured one of their members Dr. Robert
Pendergrast who's professor of
pediatrics at the Medical College of
Georgia to present on pediatric MECFS
for the meeting of the Georgia Pediatric
Nurses Association. The Georgia chapter
also sponsored Dr. Peter Rowe to speak on
MECFS in children and adolescents at
their annual meeting in June. We are also
working with the National Association of
School Nurses, NASN, to develop a way
to gather data on school-age children
affected by MECFS using school-based
surveys of reasons for chronic
absenteeism. As part of this process
NASN is educating its members about
MECFS. They had a
continuing education session at
their 51st annual conference in June on
MECFS given by Dr. Kenneth Friedman, Dr.
Faith Newton, Beth Mattey, and Michael
Newton and NASN is in the process of
converting the recording of this
presentation into an enduring continuing
education module that will be available
to their members. We've worked with
Medscape to develop a spotlight course
called "Diagnosing MECFS- The Experts
Weigh In."
This was released at the end of February.
It is free and available through
Medscape directly or using a link on
CDC's MECFS website. In addition to
obtain the numbers of persons who are
taking this course we are also working
with Medscape to evaluate the
effectiveness of the course. Medscape is
also working - with us to develop two
new educational products. One of these is
called a clinical practical assessment.
Those taking a course are asked a series
of 20 questions measuring their
knowledge of MECFS and are given
immediate feedback about the correct
responses for each of the questions. This
allows learners to easily pick up new
information and provides information
about specific learning needs for future
courses. The other course is called test
and teach and this uses two patient case
scenarios in interactive test questions.
CDC has other activities but in the
interest of time I will stop here.
However I didn't want I did want to end
with two short announcements. First I
want to let everyone know that CDC's
MECFS web pages are now available in
Spanish. We don't know enough about MECFS
in diverse racial and ethnic groups and
having information available to Spanish
speakers is an important step. I'd also
like to invite you to participate in
CDC's next patient centered call and you
can find the information about that call
on our website. Thank you very much.
Thank you very much Beth. So this point
we'll open it up for questions. We will
now begin our question-and-answer
session. If you would like to ask a
question please press star 1 from your
phone and unmute your line. Please speak
your name clearly when prompted to be
placed into the queue. Again if you would
like to ask a question please press star
1.
One moment as we wait for any questions.
Our first question comes from Denise
Lopez-Majano. Your line is now open.
Hi it's Lopez-Mojano. Thank you very
much. Dr. Unger, as you mentioned
regrettably CFSAC has been disbanded and
we have fewer ways than ever to engage
with CDC and other agencies. There also
seems to be a continuing lack of
transparency and stakeholder engagement
in the CDC's MECFS program. Earlier today
MEAction Network sent you a letter
with several detailed questions
regarding numerous aspects of the CDC's
MECFS program. Will you make a commitment
right now to promptly provide detailed
answers to our questions? Thank you very
much. Thank You Denise for your
question and I did just receive a
letter shortly before the call. And
certainly we think it's very important
to be as transparent as possible.
CDC has the has worked with the advocacy
communities. We certainly want to be
transparent and we will be working on
responses to all of your questions. I
would say I'm a little surprised that
there's this sense that we
don't want to communicate because we
definitely do want to communicate. And we
will work on improving that.
Our next question comes from Paula
Kaplan. Your line is now open.
Oh yes I was hoping to hear anything
at all about any results from any of the
research. People kept saying we've done
it, we're collaborating, but we didn't
hear any results and I also want to ask I
tried to see about getting into a study
and I was told that I was too old. I am
72 which means that, I mean I think I
represent a lot of people out there who
have had this condition for a long, long
time and it's great that you're going to
study kids and teenagers but how about
at the other end of the age distribution?
So I'll ask Dr. Breen to answer the first
part and then ask Dr. Nath to answer the
second part. Hi Paula this is Joe Breen. I
just wanted to answer your question as
best I could.
So unfortunately I can't talk about a
specific research result that's yet
unpublished. So the data that's presented
at for example the April meeting that we
had and at other forums is when the
researchers decide to talk about what
they can talk about in terms of what's
public. But until a finding is replicated
and reproduced and then accepted in a
peer-reviewed journal if I really or we
can't really talk about that in detail
because it's not, it's not at a stage
where it's really responsible to do. And
I know that's frustrating and I
apologize. What I was trying to convey is
that we do know of a number of projects
that are well on their way to that stage
and we certainly hope that we can talk
about published results moving forward.
And we're happy to do that when it's
publicly available but until that time
is just premature unfortunately. And I
think in the future we can invite
specific investigators to comment on
their on their work when when it's ready
for for primetime.
Dr. Nath do you wanna comment on the age
issue? So I emphasize with you as I'm
getting older I also advocate for studying
all age groups so the challenge for us
is that you know if you're either, you
can be all inclusive and include
everybody and then you have a very large
study and all you can do is run a very few
tests to be able to study a very large
cohort. Or you can have a very well
defined cohort and then do a large
battery of tests to try and get to the
bottom of it.
So we chose the latter because that's
where our strengths are and the disease is
such whereby we really don't have any
good leads. So studying a small cohort
very extensively I think will provide us
the best answers in a shorter period of
time and a smaller number of patients
that could then be applied to much
larger population. 
I hope that's right but because the
little is known about this family of
disorders I don't I don't know of any
reason to assume that narrowing down the
population that is studied is really going
to be helpful. In fact one of my
specialties is research methodology and
sometimes when you look at the whole
spectrum or a wide spectrum of people
you get actually more information. You'll
need a very large, as you know very well,
you'll need a very large sample size.
That's not something we can do so. That's
the unfortunate reality. Thank you that
depends on this kind of research.
Thank you. Our next question comes from
Katherine Grimes. Your line is now open.
Thank you can you hear me okay? Yes we can. 
Okay I'll make it quick I just
wanted to say something positive because
I know there's a lot of negativity on on
what information is coming back and it
just seems like the more that the more
research that I look into and the more
calls like this that there are that you
can be a part of and be in an influencer
 on I appreciate that as a patient and
that that doctors when we find it a
primary doctor that will help us, are
there guidelines that you are aware of
to help them understand? Like something
that I can give to my my provider to say
hey this is kind of where we start and
this is where we can go forward testing
or or things like that that would help
educate once we find that doctor that
says yes I'll help. Dr. Unger would you
like to answer that question? Sure we do
have pages on our website the CDC
website that are for health care
providers and it's very it it is written
as a guide to help them work through how
to care for for the patients but it is
not at the level of formal practice
guidelines because there's not not
enough known and we haven't gone through
the formal guideline process. But yeah it
was very generic I think. Yes
and we are working on materials. We had a
roundtable meeting at that about
educational materials both for the
patients and their families to take with
them when they go to the doctors as well
as some the doctors could use to collect
information from the patients and we're
in the process of getting those
documents cleared. And oh good, because
even a checklist of what what can be
done you know what can be discussed
would be because sometimes you walk in
and you just kind of by the end of it
you're already discombobulated when you
walked in to the however you got there
and then
you kind of kind of lose track right
yeah don't we go. That's what the
feedback that we got and that's so we
we're in the process of hopefully. Okay.
That it cleared. Thanks. Okay I have a
quick quick follow-up question if I can.
One question per participant. But what was that?
One question per member. Yeah okay. Shoot
all right thank you. Our next
question comes from Liz Burlingame. 
Your line is now open.
Hello Dr. Unger. I you know I think just
first of all I want to say that I am
livid.
I'm a long-term patient and I recently
went to a doctor's appointment and the
physician after relating a long list of
medications that he thought I should
take again finally said you know you
should probably just go to the Mayo
Clinic. And I told the physician the Mayo
Clinic still treats their patients with
cognitive behavioral therapy and graded
exercise therapy which we know harms
patients and the doctor replied to me
well if they're doing it at the Mayo
Clinic those treatments must be working
for someone. And I said no it doesn't.
It's bad science but the fact that those
treatments harm patients didn't affect
the physician at all and we need the CDC
to make public the fact that
recommendations that used to be on your
website and are still being recommended to
patients at the Mayo Clinic are based on
bad science and they're harming patients.
What is the CDC doing to correct this
misinformation and to better educate
physicians that what they're seeing is
post exertional malaise and their
patients cannot be psychoanalyzed out of
it or exercised out of it. We need better
science.
Thank you Ms. Burlingame. I couldn't agree
with you more that we need better
science and CDC is making it clear on
the website the recommendations that we
can make. And we are taking an account of
the information that we've gotten from
the the experts, this has been reviewed
and consulted, and we it is a very
different, MECFS is a very different
situation. Everybody's advice about
exercises can get very confusing and it
is a very different situation for
patients with MECFS and so we've tried
to be very clear about maintaining
activities that can be managed and how
to not overdo and push through and we've
made that as clear as possible. No ma'am
I disagree entirely. If the other name
for this disease is systemic exertion
intolerance disease and exertion of any
kind is potentially harmful. You never
made any kind of public disavowal of the
former treatments that we know now cause
harm. You need to. Our next question comes
from Cynthia Johnson. Your line is now
open.
Okay thank you. What I wanted to I I
heard you talking about pediatricians
and some other I'm really glad that
you're reaching out to different
specialties, but I'm out in Oregon and it
seems to be right now that family
practitioners are the people, so
they're good they're most likely to be
diagnosing MECFS and not only do they
not have the information but they don't
seem to have a code. So I'd like to just
ask you if there is yet a definite code
that comes up as myalgic
encephalomyelitis/ chronic fatigue
syndrome or not yet because with you
know I think it's confusing to the
doctors and to the patients with
electronic records if the disease gets put
in under different codes and also is
there a that's kind of a multi I guess
the other part of that it are you
reaching out to family practitioners as
well as because out here they treat
everywhere from children sometimes
instead of a pediatrician all the way
through seniors and so outside of me
educating them you know I know they're
very interested in learning more so it's
the coding and the family practitioners
are my main two question thank you or one
question. Our next question comes from
Pat Blaise. Wait wait we need a response
to that question please. And I
assume this is something CDC I could
respond to, so yes we have involved the
family practitioners in our roundtable
meetings and the Medscape educational
materials that we have are being really
targeted to all primary care physicians
and this does include Family Practice
Physicians. We realize that the Family
Practice Physicians are an important
entre group for I mean the first visit
often for patients with MECFS so they
are an important important target
audience. And then your second question
about coding is very complex and I would
say that the short answer is that the
coding has not changed from what it was
and there are two different codes, one
that comes up for chronic fatigue
syndrome and the other one that comes up
for ME. So if I can also respond to
the first part one of the things that
NIH is looking at through our Trans-NIH
Working Group and also partnering with
the patient advocacy groups is how we
can do better and more outreach to
different healthcare providers. We at NIH,
our Communications Office, does exhibit
at many of the professional meetings and
so we're looking at the development of
materials that we can distribute at
those meetings about ME as well so
and and we're working with our patient
advocate groups who also attend some
of those professional meetings so
looking at
we can do more outreach to different
community communities to help educate as
well, so thank you for those questions.
Next question please.
Our next question comes from Pat Blaise.
Your line is now open.
That's Pat Blaise. Given the fact, this is
to Dr. Whittemore and Breeden, given the
fact that this disease became publicized
and in the NIH HHS CDC 1988 and most of
the people were in their 30s, the studies
should include those who are over 75
because that the normal age was there. I
have a question as to why the coding is
separated. There should not be MECFS
acronym when a coding for myalgic
encephalomyelitis is very clear it's a
neurological disease and chronic fatigue
syndrome is fatigue and is not
acceptable.
When is the CDC going to be looked at
again through Congress to get dropped
and get everything correct so people are
not sick and not dying.
We need a congressional investigation
now. When it? Excuse me ma'am it's not a
congressional investigation. What the
change Dr. Unger said to change ICD
codes is quite complex and it's not. Not
asking about ICD codes. Congressional
investigation into the CDC and what
everybody else before me pointed out is
wrong about the CDC and how they are
continuing to misappropriate and miss
just continuing just doing questions and
act and and not doing medical science.
When do we get that congressional
investigation again against the CDC?
Because it will be the third time. I'm
sorry but I think we need to move on.
That's not a question we should
address on this call. That's right. Our next
question comes from Eric Johns. Your line
is now open.
Thank you. I first want to start with
saying that I'm just very frustrated
with decades of government agencies
paying lip service and it's basically
pathetic and a crime against the medical
establishment and patients what you guys
are doing. There's very little money,
there's very little research, and very
little attention being paid to this very
serious disease. I'd like to know what
the CDC can do to mass communicate with
doctors. We need more doctors and can you
send out an email blast to providers? Can
you send out a mailing that educates
them about the real criteria for this
disease and the real symptoms and the
treatments that can help alleviate some
of the symptoms? I think that that would
be very critical. As other callers have
mentioned, incorrect information about
exercise or psychotherapy which is
absurd, are still being advocated by
doctors and that's completely irrelevant
for a biological disease. You can look to
New York State's Dr. Zuckerberg who sent
out a letter to all 75,000 physicians in
New York State as a prime example of
something that would be very positive
for the CDC to do on a national level.
Thank you. Thank you this is Beth
Unger and we were very impressed with
what the New York State Public Health
group did in publicizing MECFS.
CDC as a federal agency does not, needs to
work with with States and it some of
those mass communications would be on a
state-by-state basis based on
the state state public health groups.
What we can do and what we have doing is
promoting our educational materials
that's available both on the web and our
continuing medical education materials
all of which that we are providing free.
We want to get this out as much as
possible which is one reason why we
started working directly with some
healthcare professional groups. The first
pilot - this with the Georgia Academy
American Academy of Pediatricians and we
will take what we learned from that
experience and see how we can extend it
out through other agencies, other other
professional medical groups because one
of the CDC's saying is one thing but
when when their own medical
professional groups are making
recommendations and calling attention to
it we think that will really help raise
it raise awareness more. I think that
that's absolutely critical but what
about a listserv? You must have a
listserv of tens of thousands of doctors
around the country that you could mail
to. That would be something simple since
it's electronic. You know having the
website is one thing but people need to
actually go to it but if they get
something in their inbox they're likely
to open it and read about it and learn
the latest of what the CDC is saying
about MECFS. So I think that going to
those individual groups is critical and
that's great but it's not enough. We need
mass attention to this disease it's been
ignored far too long.
Thank you. This is Dr. Whittemore and I
know from my work with other patient
advocacy groups, when they've been able
to leverage when one state has done
something like what was done in New York,
to leverage that and go to their state
officials and say look what New York did.
Can you do this in our state? That's not
something we can do from a federal level
but that's something that patients and
patient advocate organizations can
certainly do. If we could have the next
question please.
Our next question comes from Sandy Stone.
Your line is now open. Good morning and
thank you. For this question is for both
NIH and CDC leadership. For many years
Mayo Clinic one of America's most
prominent medical centers, has published
and prescribed medical misinformation
about ME. For many years knowledgeable
individuals in the ME community have
tried and failed to get them to correct
it. As you know, or should know Mayo
Clinic still prescribed graded exercise
therapy or GET in its clinic and on its
public website. Just a small quote
from them "gradually increasing the
intensity of your exercise over time may
help reduce your hypersensitivity to
exercise, just like allergy shots
gradually reduce a person's
hypersensitivity to a particular
allergen." This is from the Mayo Clinic's
website this morning. It's outrageous. In
light of Mayo's ongoing refusal to end
their medical abuse of people with ME
we ask that within the next 60 days
leadership leadership at NIH and CDC
contact Mayo Clinic president and CEO
Gianrico Farrugia, MD and inform him
that GET has not only been shown
unhelpful to people with ME, it has
also been shown to be potentially
harmful. If Mayo Clinic did the same by
telling diabetics to gradually consume
more sugar would any of you sit by while
people are being harmed or worse? Your
inaction on this topic is simply
indefensible. We need you to actively
protect us from ongoing medical abuse
and rampant anti-scientific medical
ignorance and I was going to say this to
Dr. Koroshetz and it certainly applies
to you Dr. Unger I'm sorry to say, please
do not insult us or waste our time with
your excuses. We need action. Thank you.
Thank you for raising this concern and
we'll discuss this and look at how we
could address this issue going forward.
So thank you for for bringing that to
our attention. Next question. Next question
comes from Wilhemina Jenkins.
Your line is now open.
Wilhemina Jenkins yes. And I want to
speak with Dr. Unger. Dr. Unger I was a
little startled that you thought there
was adequate communication going on in
the absence of CFSAC between CDC and
the community. What little community
communication we've had has been one way.
You invite us in on occasion, we give
some information to you, but we never have
any direct communication back and forth
on the things that are going on at CDC
and that's essential. One thing that I
wanted to speak about in particular is
the current pediatric effort that's
going on from CDC here in Georgia. I'm in
Georgia, we have large number of
advocates here in Georgia who had
connections with the CDC in the past. I
have had a child who became ill with
this disease as a teenager. I can't
imagine how CDC could just have one way
communications, could not use the
information that's available from
patients and some stakeholders who've had
to live with a teenager with this
disease, a young person with this disease.
Just having the doctors work on it alone
is not going to give us the best
results. We have information. We have the
ability to communicate it. We know where
the missteps can come because we have
lived with young people with this
disease. I know that this is one of the
questions on the letter that has come to
you from MEAction but I want to
emphasize now we have to have two-way
communication not one-way communication.
Our calls from you are one-way
communication. We listen to what you have
to say. We need to have a dialogue not
just a little bit of information back
and forth. I believe
that stakeholder and caregiver
communication is tremendously important
and seeing that the pediatric study here
in Georgia is as good as it can possibly
be.
There are very few things that are
disturbing as having young people come
down with this disease. We have to find a
way that we have true input into the
into the studies that you're doing. There
are there are people here ready to do
that. We are informed you know ready to
work. We can make your study and your
efforts a better one if we can have
stakeholder and caregiver engagement not
just one way communication. Can you can
you let us know what way that you can
incorporate our efforts into your efforts?
Thank you Wilhemina and I definitely
can say that we are, we need to
improve our communication. This you're
that you're talking about our pediatric
study is really a continuation of the
study and the study design and the
questionnaires that we've already
started so we need to continue and
complete it so the data will be
comparable. Where I think we definitely
need parent and caregiver and patient
communication is about the educational
materials and what they need from their
doctors and that was what we started at
the stakeholder 
meetings the roundtable meetings that we
had. We need to have a faster turnaround
and make it clearer that we are
listening and receiving feedback. We will
also be discussing ways to in more
systematically have ways to communicate.
So thank you for pointing this out. This
is Dr. Whittemore and I'd also like to
inform the community if you're not aware
that Solve MECFS Initiative has a
registry where any individual with 
MECFS can register and provide your
medical information on an ongoing basis
through that registry. And Solve MECFS
Initiative is also partnering with the
collaborative MECFS research centers to
develop an app that would more
accurately track your daily variation in
symptoms, daily, weekly variation of
symptoms, and that's a research project
that they're working on together with
the collaborative center so that will be
launched it's in beta testing now and
will be launched soon. So I think that
there are ways that we are also trying
to reach out and partner with our
patient advocacy groups to try to obtain
that information directly from
individuals with MECFS and their
caregivers. So watch for more information
about that and we'll make that
information available as soon as as it's
available but if you go to the Solve
MECFS Initiative website you can find
information there about their registry.
So we'll take the next question please.
Our next question comes from Kathleen
Jones your line is now open.
Hi good morning I want to come back to
the idea of getting communication out to
doctors. It sounds like you don't have a
national listserv of doctors or that
sort of thing where you could do mass
communication but I'm wondering can the
CDC or NIH I guess I'd be a CDC
responsibility to work with the State
Departments of Public Health to have
some action like what happened in New
York in terms of informing all the
doctors. Rather you know what I heard is
patients should make efforts to do that
well you know one we are trying in some
states, but you know a lot of patients
don't even have diagnosis they don't
know what's wrong with them because the
doctors don't know how to diagnose it so
rather than you know 50 efforts from 50
states
I guess 49 because New York has already
done it could
you know can we have an effort from the
top from CDC to you know kind of move
these state public health departments to inform their
doctors about MECFS and how to diagnose
it and patients certainly would help
those efforts but asking  us to do it
on our own is a big ask. Sorry
about the duck. I appreciate, I appreciate
that comment, Beth do you want to respond?
I can respond a little bit and we have,
we are interacting with the state public
health departments through the BRFSS.
We find that what works really well is
that when we contact a public health
department and they've already heard
from advocacy that this is an issue in
their state then they're more receptive
to our inquiries and and we definitely
agree that it should not be totally on
the the patient advocacy community to do
this. We are reaching out and will
discuss ways to increase this further.
Thank you next question please.
Our next question comes from Claudia
Carerra. Your line is now open.
Hi um thank you for taking my call. I have
a couple of comments to pick up on from
other people but also some specific
questions. So one broader question is I'm
wondering why, I think overall we need a
paradigm shift. I know you've heard this
before but we need urgency we need the
patient, we need patients to be fully
integrated. It's not just communication
or transparency it's we need patients to
be integrated in every step of every
action that our federal agencies are
taking because at this point the patient
community is at the forefront of making
connections like
we are ahead of the doctor and
researcher curve in making connections
and understanding about the illness and
we are the ones who suffer the
consequences of misstep so there must be
nothing about us without us. So I'm glad
to hear that the NIH will be publishing
both the incoming recommendations they
received of the RFI process and
publishing the report. I think the CDC
needs to be doing that with every single
action that they take. We should know who
is involved in these stakeholder
meetings that helps set up that helps
frame studies. We need that to become
public, we need to know who is involved,
we need to know what questions were
asked we need to know what the plan is
at every step of the way.
That needs to be published and and it's
not enough to involve one patient
representative or one patient advocate
because the community is very diverse
and it is through our diversity and our
communication with each other and in
comparing we in a way we are able to do
the you know the NIH might be limited to
a study with a small number of patients
in depth but we are the ones who are
communicating amongst ourselves in
figuring out what connections there are
among all of us and in many ways one
example of the way in which I think we
are ahead of the curve is that there's
strong emerging evidence that brain stem
and upper spinal cord compression is the
causal mechanism for at least a subset
of MECFS patients and more specifically
a growing number of well characterized
long-term MECFS patients are being
completely cured by spinal surgeries to
correct structural problems such as CCI,
cervical stenosis, and Chiari
malformation. I don't know if any of you
on the call are aware of that yet but
patients are. And so one question I had
one specific question was in the NIH
intramural study are brainstem and upper
spinal cord focused tests being
performed and a specific example is I'm
wondering if cervical traction is being
utilized to investigate the effect of
spinal cord decompression on autonomic
autonomic function and if not if that
procedure can be added to the battery of
tests. But that's just one example of how
patients need to need to be involved
at every step. It requires a paradigm
shift maybe it requires additional staff
members but if you do not do this you
are literally placing all of your 
effort at risk all of this millions of
dollars and we are your funders, we the
taxpayers, the public, are your funders we
must be involved in setting priorities
setting plans, we must know the
information, we must know what is going
on at every step of the way and be able
to weigh in and once there are big
studies done we also need
recommendations to be implemented
immediately there needs to be real
urgency for this because of all the harm
the agencies have perpetrated over the
preceding decade. So I know the NIH
stated that the NIH is working group
recs will be taken up at September
but I want to know whether those
recommendations will be integrated into
the 2020. Dr. Nath would you like to
respond please? The question that was
asked of me was about the cervical spine
stuff. So yes we are very aware of those
diagnoses that have been made in some of
these patients. Let me assure you that
every single patient is very thoroughly
examined for any possibility of cervical
spine disease whether it's Chiari
or any other kind of compression or
autonomic dysfunction. And we've diagnosed
a lot of other neurological diseases
that people are missed on these patients.
So we are extremely thorough and we're
very well aware of it and we examine
every single patient for that
possibility including the neuro imaging
that you were talking about. Thank you. We
have time for one more question. I know
there are others of you waiting to ask
us questions. Please send any of your
unanswered questions to braininfo@ninds.nih.gov
or go to the NIH MECFS
website and click on contact us to
submit those questions. Now let's have
one last question. Our next question
comes from Lottie Vann. Your line is now
open.
Alright thank you for taking my question.
I am one of the few lucky ones that was
diagnosed with MECFS 34 years ago so
having a diagnosis was not a problem but
during conversations with doctors you
know there's always been that gee I
really wish I knew how to help, I don't
know what to do, why don't you try this
is that. But when it gets down to
providers the last couple years even
though I'm finding more and more
providers that can have conversations
about I'm also starting to talk to
providers who are working for hospitals
or HMOs that seem to have a structural
opposition to reviewing files of
patients that have already been
diagnosed with CFS and this includes
pediatric hospitals and I'm wondering if
the CDC can do something to engage in
conversation not just with the hospitals
with the doctors but also start
talking to the hospitals and HMOS. Dr.
Unger do you want to comment on that? Well I
was not aware specifically of a problem
quite like that that there was something
that they wouldn't allow the prior
documents to be reviewed, but the
suggestion of working with the managed
care organizations is is really an
important one. We have had one indirect
entre into there it's been hard to get
their attention and we are working with
them on a research project to see if we
can characterize MECFS patients in
their files so they have an idea of the
burden of the illness. We're working
through working in this in a subcontract
with another group at CDC. So I think
you're you're absolutely correct that we
would like to work more with managed
care organizations because that would be
one way to really
yet a systematic approach to MECFS in
their patient organizations once they
recognize it. As an added note I noticed
that there were some representatives
from some HMOs on the call this
afternoon.
So I think doing outreach about these
calls also to some of the HMOs and
hospitals is something that we can do
to get them involved in these
telebriefings as well. So thank you Dr.
Unger for your comments and thank you
everyone for joining us this afternoon
and we need to wrap up the call and I'd
like to turn it over to Ms. Warren for
closing comments. Thank you. A recording
and transcript of the call will be
posted to the NIH MECFS website
very soon.
In closing today's call I'd just like to
remind you about our listserv for
updates from NIH. To be added to the
listserv please visit the NIH MECFS
website and click on join our listserv
at the bottom of the left sidebar. Thank
you for an informative and thoughtful
discussion. Good afternoon. Thank you
everyone.
Thank you for your participation in
today's conference. You may disconnect at
this time.
