Welcome and thank you for standing by for
the duration of today's call all
participants will be in a listen-only
mode to the question and answer session
of today's call also I want to inform our
participants that is call is being
recorded if you have any objections
please disconnect at this time thank you
I would now like to turn your call over
to Ms Gallagher thank you you may
begin good morning my name is Alissa
Gallagher and I'm from the Office of
Neuroscience Communications and
Engagement at the National Institute of
Neurological Disorders and Stroke on
behalf of the NIH I would like to
welcome all of you to this morning's
telebriefing and to thank you for
your interest in participating in this
discussion with us today Dr. Walter
Koroshetz director of NINDS will
introduce the speakers each of whom will
make some remarks after which we'll open
the phone call for your questions we'll
try to make our remarks brief so that we
can answer as many questions as possible
in the time that we have available to us
this morning we also request that
everyone asks only one question so that
we can hear from as many of you as
possible now I'd like to turn over the
call to Dr. Koroshetz. Good morning can
you hear me all right? Yes
well thanks everyone for joining these
are I'm sure difficult times for
everyone but particularly for those with
ME/CFS and so we want to just start off
by wishing everyone the best in health
as we try to get through this viral
pandemic and I'm sure that this is upset
the plans of many people including folks
here at NIH we are now all working from
remote areas and I actually have a
particularly the common cold but I'm
home
calling into this conference
being careful not to let it it's contagious
nature affect anybody else and apologize
for my voice as we as we go through now
as as in the past we want to let the
community of both scientists and patients and
advocacy organizations know about the
research that we are working on in and
our grantees are working on and also
answer questions from folks about their
research and about NIH and how
NIH works we think that this is the best
way of communicating on a regular basis
with the community so that folks know
you know what the up-to-date information
is also on these calls we are
looking forward to bringing in guest
speakers and today we have Dr. Leonard
Jason from DePaul University and the
speakers that we bring in are people who
are dedicated to ME/CFS research and most
of them have NIH grants to study ME/CFS
until you get to hear from the
experts that they're doing and what how
they are thinking about the problem and
trying to bring solutions
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we today had hoped that Dr. Nath the ones
the intramural program would be able to
join us but I think we understand that
he is he's currently on the consult
service in the hospital and I don't
think he was able to get out of the
hospital service today to join us
but we'll get an update on the
intramural program at our next meeting
so I think now what we're going to do is
move to updates. Dr. Breen is going from
the National Institute of Allergy and
Infectious Diseases will give an update
on the data management the clinical
center in the consortium. Dr. Whittemore
will talk to us about updates from the
Trans-NIH ME/CFS Working Group and
implementation of the council's working
group report you may recall that at our
council meeting I think it was I got it
right it was in September we had a
presentation of the working group on
ME/CFS to our council and they were
working on those recommendations. Then
we'll move to Dr. Jason and then we'll
have a Q&A. So with that let me ask Dr.
Breen if you want to get an update on
the consortium. certainly thank you
Dr. Koroshetz
I want to, my name is Joseph Breen and I
work closely with Vicky Whittemore and
the rest of the NIH working group and I
want to talk to you a little bit about
the progress that's occurring at the
three collaborative research centers and
then the data coordinating Center
so as you likely know that one of
the research centers is at Cornell and
I'm excited to tell you that they've had
a paper that was recently published in
the Journal of Clinical Investigation
if any of you participated in the
previous call I mentioned that we were
getting excited at this stage of the CRC
network that we anticipated that they
would have peer-reviewed work that would
be published in the next intervening
time really showing that the
productivity of a center that was stood
up that took some time to get started
would really start to reap some benefits
and
think that's what we're seeing and I'm
going to talk to you a little bit about
a few of those that are now
peer-reviewed and publicly available and
actually can be can be seen on PubMed
and other ways to look at this kind of
work
so the work by Dr. Maureen Hanson and
colleague showed altered T-cell
metabolism and cytokine associations and
this work is important and this was
shown in ME/CFS patients compared to
controls because it shows that T-cell
metabolism is actually consistent with
ongoing immune alterations that immune
dysregulation has been seen for a number
of years but really understanding that
metabolism in the immune cells
themselves was not previously
demonstrated and certainly not
demonstrated to the level of detail
shown in this study recently done by
Cornell which was published in December
2019 in the Journal of Clinical
Investigation at the same time period uh
Dr. Hanson published a short report in a
journal called metabolites showing there
were differences in some lipid and
steroid metabolism in ME/CFS patients
compared the controls and this the
differences were more subtle but this
has been noted at least one other time
in the literature and I think it
deserves further follow-up and I'm and
further a development of analytical
techniques actually to get at this in
more detail and I think it will add to
the picture of trying to understand
what's happening with the immune
dysregulation and potentially some lipid
metabolism so that's from a basic
science perspective it's it's all more
understanding of mechanism in the center
run through Jackson Laboratories with
Dr. Derya Unutmaz they also have a
recent paper that is under review at a
peer-reviewed journal but is already is
submitted to the bio archive repository
where it can be
read by the public and this paper is
about the perturbation of effector and
regulatory T-cell subsets so T-cells are
a specific type of immune cell similar
it's in some ways to the cells that that
the Cornell group was looking at but
this study was a little bit different
and has really looked down into the
types of subsets of these immune cells
and they see certain patterns that some
cells of the activity goes down while
others have has gone up in particular
some T-cells called T regulatory cells
seem to be higher in ME/CFS patients
again pointing to immune dysfunction
which may point out chronic inflammation
or a chronic response to inflammation
and also and they're also looking at
this in detail some microbiome dysbiosis
which is another area that the Jackson
Labs is really an expert in is applying
to this ME/CFS model and I think again a
better understanding of the immune
dysregulation is will help to point to
mechanisms and hopefully identify some
potential therapeutics and the third
research center is Dr. Ian Lipkin they
have some work that's recently been
submitted for publication about from the
plasmic proteomics program suggesting an
association between antigen the clonal
B-cells expansion and ME/CFS so the
previous studies that I mentioned were
in T-cells and T-cells in one sense are
the cells that turn on your antibody
producing cells so this would be a
different kind of study we're looking at
the B cells which ultimately do produce
antibodies so I think two driving
associations that are pointed out by the
Lipkin group I think would be a novel
contribution and again
and highlighting that better
understanding of mechanism will help us
understand etiology and the pathogenesis
of this form of ME/CFS overall and begin
help us presumably to come up with a
biomarker to measure it as well as
design some therapeutics they also have
ongoing projects collaborating
between the three centers looking at
different t-cell populations but taking
into account the strengths of each of
the centers for example the strengths
and the microbiome analysis at the
Jackson labs and then some of the
metabolomics that's present in several
the center's and I look forward to talk
to you about that work in a future
update and all of the centers had
multiple abstracts submitted to the
International CFS meeting planned for
June. The data management coordinating
Center has been involved in activities
to coordinate activities sharing data
through that are generated from each of
the center's and will soon be launching
a way for the public to see that and
really I think that will be a quite an
unveiling and is that actually helping
to organize even things such as meeting
between collaborative projects between
the three centers and really improving
the synergy and I look forward to
updating you on those activities in the
future well that's the update from the
Clinical Research Centers or the
coordinating and research centers and
the data management center. Vicky? thank
you Joe okay they think you want to talk
to us a little bit about the
observations from the council working
group report yes absolutely so we have
been working to put together a workshop
this that we were
going to hold this spring to focus on
discussions around clinical outcome
measures, clinical patient reported
outcome measures and clinical trials in
ME/CFS but because of the situation
we've decided instead to move and we
just talked this through with the
Trans-NIH working group yesterday and
will be working with the NINDS office
of science office of policy and science
policy and planning sorry to coordinate
these activities but what we are
planning to do is to put in place a
series of webinars focused on several
topics that were raised in the report
that it addressed several of the
strategies and in particular a lot
of the issues focused in on in the
appendix under strategic planning so
really to involve ME/CFS
stakeholders in the discussion of these
different areas that will then inform a
research plan on ME/CFS so that that's
underway and we will be reporting out on
that as soon as we have those
plans in place in addition we have
continued to work with the Common Data
Elements Oversight Committee to continue
to modify and refine the Common Data
Elements that are in place for ME/CFS we
are working with BioSend which is the
NINDS funded biorepository at
Indiana University to put it they now
have all of the biospecimens from the
study that was funded to collect samples
originally funded by the CFI Initiative
and the Hutchinson Family Foundation so
all of those biospecimens will be made
available from BioSend and together with
the clinical data that was collected in
conjunction with that study which is
currently being housed and cleaned at
RTI at the data management
coordinating Center for the network we
have been working very closely with many
investigators who have contacted us to
talk about research grant applications
they would like to submit and also
talking to individuals who submit grants
when they're not funded we work with
them to talk through the discussion in
the summary statement once they've
received the reviews back to help them
with their resubmission and then in
we've also Andrew and I have had several
discussions with the office of training
at NINDS around with things that we can
do and put in place to help the pipeline
of young investigators in ME/CFS
research as well as to strengthen and
improve mentoring in this area of
research as well and so a lot of these
things are as I said in the works and we
will be rolling out a lot of information
about our activities in the coming weeks
and especially around the planned
webinars so stay tuned for more
information thank you oh I forgot one
important thing I'm sorry the
interagency working group so we have
decided to partner with the CDC to put
the interagency working group for ME/CFS
in place we're working on getting the
invitations for that working group out
and are hoping to schedule the first
meeting again because of the
circumstances likely a webinar sometime
in late spring or early summer so that
that is also moving forward
that's all I'll turn it back to
Dr. Koroshetz thank you very very much
Vicky yes so that'll be great where the
agencies be able to get together and
talk about their research and coordinate
so we're really
looking forward to getting that group
together and I guess also to mention yet
yesterday there was NINDS and a number of
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00:17:55,559 --> 00:18:01,470
the other institutes belong to what's
called the Neuroscience Forum at the
National Academy of Medicine and
yesterday we were able to get on the
agenda a very interesting session on
what's understood about how the brain is
involved what circuits in the brain are
involved in fatigue so it's kind of
the neurobiology of fatigue and you know
so it's it's heavily in say animal
studies, people looking at the different
brain circuits and creating fatigue
models trying to then develop
medications that may actually improve
fatigue in these animal models so as
science moves frequently you know there
were discoveries in animal research that
then leads to hypotheses to test in
humans and so I was quite impressed by
the group and also we got a lot of
people both neuroscience academia and
industry thinking about fatigue and its
mechanisms so hopefully that at some
point can translate into a benefit for
ME/CFS community so I just wanted to
bring that up and now I think we like
very much to turn to Dr. Leonard Jason
he's the director of the Center for
Community Research at DePaul University
in Chicago and he'll tell us about his
recent work that was that was published
in the Journal of Child and Youth Care
Forum in which they did a very what
looked like an incredible amount of work to get at
the prevalence of ME/CFS and children and
then he's also been awarded
an NIH grant again on investigating ME/CFS
after infectious mononucleosis so we're
really pleased to have you here
Lenny and please take the mic and give
us a summary of the work that you've done
and what you plan to do thank you thank
you very much I appreciate the
invitation
I very much appreciate 25 years of NIH
funding for our ME/CFS Research which
began in the mid 1990s with an adult
community-based prevalence research and
this work is now extended to youth ME/CFS
significantly impairs various aspects of
children's and adolescence lives
including physical functioning school
attendance and extracurricular
activities one investigation found only
14% of adolescents with ME/CFS attended
school regularly another study found
that ME/CFS to be the most common cause
of prolonged medical leave from school
among adolescents descriptions of ME/CFS
and pediatric samples have often
described the patient as being athletic
ambitious upper-middle class before they
got the illness these findings have some
similarities to how adults with ME/CFS
were described following the first
generation of adult
epidemiologic studies previous studies in this
pediatric prevalence area have found
rates of about 2.7 to 1,900 per 100,000
however many of these studies relied on
physician referrals which excludes those
who do not have access to medical care
and this exclusion may have reduced
previous prevalence estimates in
addition not all prevalence studies
included a physical examination and
screening laboratory evaluation to
exclude other diagnoses in an effort to
control for those deficiencies
encountered in many of the prior
ME/CFS epidemiologic studies our studies
collected data from a community-based
ethnically and socially demographic
diverse sample and provided
test positive and
test negative youth medical and
psychological examination we hope these
methods would generate a more accurate
estimate of pediatric ME/CFS prevalence
in the first stage of our study we
involved calling households in the
Greater Chicago metropolitan area as
parents were contacted over the phone we
found out whether or not they had youth
5 to 17 years of age the pediatric ME/CFS
screening questionnaire which we
developed was administered to
respondents to screen for ME/CFS like
profiles among children adolescents
those with no exclusionary medical
conditions who screen positive for
either significant fatigue or school
learning memory problems or had
substantial reductions and functionings
and three or more ME/CFS symptoms were
considered screen positive and selected
for full evaluation so they had to have
all those different characteristics to
screen positive however we also had
screen negative control participants
matched for gender age ethnicity for
Stage two of the study parent and youth
who agreed to participate met criteria
came to Lurie Children's Hospital for
structured psychiatric interview
psychosocial assessment and medical
evaluation by Dr. Ben Katz the
parent and youth completed the
pediatric version of the Paulsen
questionnaire the Child Health
Questionnaire the autonomic symptoms
checklist and fatigue severity scale we
also had filled out the scheduled
affective disorders and schizophrenia
school-aged children this was separately
given to the child and parent we
screened 5622 households and had data
from about ten thousand one hundred
children and adolescents um of those who
screened we had basically 298 reported
prolonged unexplained fatigue and
additional symptoms so they all met
criteria for what's called a screen
positive we eventually ended up working
up 165 of these and the matched control
group at the end of stage 3 a team of
physicians were responsible for making
final diagnoses
two physicians independently rated each
youth according to the ME/CFS case
definitions of Fukuda what's called a
pediatric criteria modeled after the
Canadian clinical criteria case
definition and the more recent IOM
criteria reviewing expert physicians had
access to all information gathered on
each participant during each of the
three phases of the study the
individuals evaluated for ME/CFS had to
meet all three case definitions so let
me talk a little bit about the results
now there were no significant
differences between screen positive
subjects and screen negative in terms of
gender race ethnicity and age the
prevalence of ME/CFS in the
community-based pediatric population was
found to be 0.75 that's basically 750
per 100,000 or approximately one out of
every 134 youth females were found to
have a higher prevalence rate of ME/CFS
than males the prevalence rates of ME/CFS
were higher for Hispanic Latino and
African-American individuals when
compared to Caucasian youth in those
aged 14 to 17 had higher prevalence
rates than younger children there were
no significant differences found between
participants with ME/CFS and controls in
regard to gender race ethnicity and age
significant differences were found
between participants with ME/CFS and controls
in regards to number of symptoms
reported duration of fatigue fatigue
reports and fatigue severity scale
autonomic symptoms checklist and symptoms
most importantly of the 42 youth
diagnosed with ME/CFS only 2 or 4.8% so 2
out of 42 is 4.8% had been previously
diagnosed with ME/CFS thus most youth
with this illness are not diagnosed so
let me kind of try to wrap this up and
give you what I think are the important
points substantially higher prevalence
rates of ME/CFS were found for females
individuals from racial ethnic
minorities and older children
higher rates among minorities could be
due to them having less access to
adequate health care higher rates among
older youth compared to the younger ones
could be due to hormonal changes
inherent in adolescents younger youth
might also be exposed to fewer
environmental and biological
precipitating causal factors conceivably
those who are older might be less
physically fit or have more
opportunities to experience other
physical illnesses or stressors that can
cause fatigue most importantly less than
five percent of the identified youth
with ME/CFS have previously been
diagnosed with the condition this
finding is comparable with adult
community based findings regarding
majority of adults also not being
identified previously these findings
point to the need for better ways to
identify youth with the illness and to
develop appropriate rehabilitation
interventions for them the lack of an
agreed-upon case definition has
complicated efforts to estimate
prevalence rates of pediatric ME/CFS
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00:27:33,340 --> 00:27:39,950
three widely used case definitions were
used in the study with diagnostic
criteria ranging from a very broad
perspective using the Fukuda to more
stringent criteria of the CCC and IOM in
the current study individuals diagnosed
if they met all three case definition as
we use the conservative strategy to
accurately identify cases the CCC
pediatric criteria was found to be
the most stringent in summary we
determined the prevalence of pediatric
ME/CFS in the community to be about 0.75
percent in addition it appears that
females those from Hispanic Latino and
African-American ethnicities have higher
rates than Caucasians of particular
importance over 95% of identified youth
had no previously not previously been
diagnosed autonomic fatigue and
symptom data suggest that those who have
this illness have significant and
multiple impairments and thus represent
a high-risk group that needs to be both
diagnosed and appropriately treated
since receiving considerable media
attention from the study Cort Johnson of
Health
Rising conducted a poll that found that
44% came down with ME/CFS before age 18
while this is probably a self-selected
sample it is possible that adults with
this illness did have the disease
earlier the only way to really better
understand that issue is to conduct a
prospective study of individuals who are
well and then follow them when they get
ill with ME/CFS we are engaging in such a
study now with my colleague Dr. Ben Katz
we have recruited a sample of about
4,500 college students and had them
provide blood samples and fill out our
DePaul symptom questionnaire and they
filled these things out when they were
well about 5% in college went on to
develop mono and we have now assessed
those youth that when they develop mono
and followed them up at 6 and 12 months
follow-ups some of whom ended up
recovering some of them who did not our
new grant will allow us to follow-up
these important cohort into the next 5
year period and again we appreciate
funding from NIH and NINDS for this work
studying youth and young adults might
provide us with unique insights into the
pathophysiology of this illness most
research in our field has been on adults
who have been generated from tertiary
care settings with possible
complications from other age-related
illnesses our focus on youth from
demographically diverse samples are that
unbiased by chronic illness or help
seeking might help us better understand
autonomic cytokine metabolomic genetic
and other potential biological markers
um thank you and look forward to
answering any questions on the study ok
thank you very much that that is an
incredible amount of work could you talk
to us a little bit about the team that
was assembled to accomplish this work
sure um you know we have a physician
Dr. Ben Katz who does infectious control
at Northwestern and Lurie Children's
Hospital
and we've been collaborating on both the
adults as well as the pediatric studies
for many years but I would say he is
really one of the key factors in our
work and really taking the field of
psychology which I'm a member of and him
in medicine research fits nicely what we think of
as translational research of course we
have a team of physicians one
psychiatrist two of whom are non
psychiatrists who basically are involved
in looking at the individuals and also
making a diagnosis of whether they have
ME/CFS or not and so we we have a team
that basically does a clinical
evaluation we also have you know lots of
interest in this type work from other
professionals who are both graduate
students becoming trained in our fields
my field is clinical community
psychology and also we have individuals
who are undergraduates who get some
training and research methods we have
literally hundreds of volunteers from
DePaul University students who actually
helped us made the thousands of phone
calls which we generated over multiple
years so they had opportunities to
get some research training and
generating samples so those are some of
the key people but certainly there are
other folks that you know we're now
working with on the new grant so yes
it's a very multidisciplinary approach
for our work yeah I mean just looking at
the it correct me if I'm wrong but it
sounds like there were a hundred and
forty seven thousand nine hundred phone
calls and forty three thousand
forty-five phone numbers were reached
that that is that is a tour de force I
think well thank you and you know
certainly uh you know you know what we
wanted to do was to try to generate a
sample that didn't necessarily
come to you know like the tertiary care
settings and to do that one needs to
sort of go out at a random community
samples and it is expensive type
research takes a long time but I do
think the results we get from those
types of samples might be different very
much so from those who end up ending up
coming into tertiary care settings and
let me ask do you have the capability
and the consent to follow up the
affected individuals that you identified
I think there were 965 or
something like that yes um and that's
what we're actually right now in the
process of recalling the actually the
44,500 and we're trying to and we're
actually um you know as well as the ones
that were brought into Lurie Children's
Hospital we're also calling the other
folks and if those folks became
symptomatic in the 5-year follow-up we
will bring them in and evaluate them so
we will be able to actually look at the
emergence of new disorders new ME/CFS as
well as the maintenance of ME/CFS in
these two very large samples but of
course the ones we're most particularly
interested in are the ones that we have
yeah so so yes this is the mono study for
college students in that particular
group we are following up the
epidemiology study which is again I
think a very valuable sample we are
we've wanted to do follow-up data on
them and we do have permission to
do that but we don't have funding to
do that at this point okay sounds good I
would say right again that that's that
like a great population to follow now
super well very good well thanks for
watching sure there'll be questions from
the folks listening on the phone before
we go to questions I do want to mention
that we received hundreds of holiday
cards letters and photos
from the community in December and I
want everyone to know that you know
we feel strongly as do all the letter
writers that there needs to be more
research in this disease and folks on
the phone and in our on our Institute
and in NIAID where Joe Breen is working
hard to make that happen and we do
understand that there's terrific
suffering going on there out in the
world where folks are suffering with
ME/CFS and although we're making progress
it is way too slow and we'll do
everything we can to try to encourage
investigators such as Dr. Jason who you
heard here to kind of devote their
career to better understanding this
illness and I guess before we go and I
think we need to say something although
I'm not sure how much information we can
give you about the potential interaction
of covid 19 with ME/CFS and Dr. Joe
Breen from the NIAID talk to you a
little bit about the immune findings that
have been coming out in ME/CFS
and I wonder Joe could I know we can't
give you know medical answers but at
least give you you know what the expert
opinion is on covid-19 and ME/CFS
intersection Joe would you be able to
address that so thank you Dr. Koroshetz
so what I can say is that when
we actually this week had a call with
the collaborative research centers they
are intensely aware of the situation
with covid-19 and how that's affecting
ME/CFS patients and could potentially
involve more and they're understandably
quite concerned as they're still
recruiting patients for the ME/CFS
studies that I mentioned and others that
are still ongoing I think
that the reality is that we don't
know a lot yet I think that worldwide
research teams are collecting a
tremendous amount of information much of
that has been turned around and made
publicly available through websites such
as those at the CDC with coronavirus.gov
which will take you to a number of
resources and then the WHO the World
Health Organization has a similar
website for covid-19 with information
that's more globally based and there are
a number of ways this is being tracked
so as of yet we don't have research
connections between covid-19 and ME/CFS
but I think I just want to let people
know who are listening that you know
certainly researchers and clinicians are
paying attention and of course right now
that the priority as is quite public is
on testing available therapeutics and
development of vaccine but I think right
behind that are recruitment of
longitudinal studies which from cohorts
from all kinds sectors of society which
will also include ME/CFS sufferers so I
think at this point I think it's very
quite public about advice and things to
do to keep yourself healthy and I would
recommend that people visit those
websites the CDC and the WHO website for
the most up-to-date advice and know that
you know I described the research
progress on these immune phenotypes and
it's and we realize that you know
that's relevant to covid-19 but at
this point the best way to keep yourself
informed because these a research
project is to really look at the corona
virus site on the CDC and the WHO and
of course that I'm happy to take questions
when we get to that stage well thank you
thank you Joe Alissa I think we can go
to the questions now that correct yes I
think we can go ahead and get started
thank you we will now begin the question
and answer session of today's call to
ask a question please press star one
unmute your phone and record your name
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question
to withdraw your question please press
star two again to ask a question please
press star one thank you it may take a
few moments for the calls to come
through Denise Lopez-Mojano your line is
open
good morning thank you very much for this
very important call and in particular
Dr. Jason thank you for your
presentation and for your work your
recent paper on the prevalence in
pediatric populations highlights the
very sad state of underdiagnosis
disparities and research
populations and clinical populations I
have so many questions for you but let
me start with did you examine any of the
biological indicators in this prevalence
study for the people involved yes we
actually um have um blood samples in deep
storage and saliva samples in deep storage
and we also as was mentioned would be
most interested in follow-up studies we
think it's a really unique sample and we
think that those biological samples
could really help us to make predictors
so far to now we haven't been successful
in being able to secure NIH funding but
we hope maybe that things change in the
future
the next question comes from Terri Wilder
854
00:41:46,670 --> 00:41:52,849
there your line is open
hi thank you Dr. Jason thank you so much
for your presentation and it's been
really helpful for me to read about it
as I reach out to medical students at
medical schools and my question actually
is about something a little different on
March 4th activists with ME
interrupted Dr. Francis Collins' opening
statement in the House Appropriations
LHHS subcommittee hearing to demand that
the NIH take urgent comprehensive action
to respond to the crisis of ME that's been
growing unchecked for more than three
decades Dr. Collins responded to the
protesters demands by saying I quote I
do want you to know that the condition
ME/CFS chronic fatigue syndrome is of
great concern to the NIH he added that
he quote would like very much to talk
about it at a later point he never did
talk about it in the hearing despite the
fact that the chair of the subcommittee
gave him permission to do so this was a
huge missed opportunity to educate and
raise awareness about this disease the
NIH has neglected ME for 35 years and
has ignored the repeated recommendations
of Congress to quote expand ME/CFS
effort including provide set-aside
funding for ME research consensus on
the ME case definition incentivize
researchers to enter the field
furthermore the 2021 budget requests note
on ME says nothing about providing
any new funding for ME initiatives and
the projected 2021 spending on ME is the
exact same as 2019 so that means that
not only no new funding this year but no
new funding in the next year we really
need more than concern from Dr. Collins
and the NH we need comprehensive action
now the protesters who interrupted
the subcommittee hearing are part of a
growing movement of people with ME who
are demanding justice via the not enough
for ME campaign you already mentioned
part of that campaign which was the 500
holiday cards sent to Dr. Koroshetz
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00:43:48,440 --> 00:43:53,450
the activists on March 4th put their
debilitated bodies on the line to tell Dr.
Collins to stop the excuses and fund
ME research so the millions missing
can return to their lives our community
needs the following questions answered
by the NIH why didn't Dr. Collins
include our disease in his opening
remarks to the committee he named many
other diseases and could have certainly
named ours and two why did he dismiss this
opportunity given to him by the
committee chair to share information
about our disease and our needs to this
committee we're very upset about this
and need these questions to be answered
both Dr. Joe Breen and Vicky Whittemore
920
00:44:28,190 --> 00:44:32,059
know who I am
and can send me his answers via email
along with a written plan on how he will
include our disease and needs when he
gives testimony to the Senate
regarding the NIH budget okay thank you
very much I think you know as I
mentioned earlier you know here at NIH
we are I think we are on board
with the request that ME/CFS funding
be much more robust we don't think
that at the current level it's it would almost
take a miracle to solve ME/CFS we need
we need folks like Dr. Jason and
probably up maybe 500 to a thousand or
more to dedicate their careers to ME/CFS
and that's the goal that we're
working towards and and we need to do
that with the patient groups NIH is a
funding organization but it's really the
patient organizations that motivate
people that like Dr. Jason to devote
their careers to research on a
particular topic and I think it's
happening but it's got to happen much
faster with regard to Dr. Collins I had heard
about the hearing I can certainly
bring up to him your points I would say
however that that the added action on
the part of NIH was really something
that Dr. Collins instigated and
triggered so all the work we're doing
now I think is a result of him charging
the Institutes to move much faster and
more aggressively into ME/CFS research
and so he is your champion no question
about it now he has lots of things on
his plate but I will say that ME/CFS is
an important issue for Dr. Collins and
has been for you know for a number of
years now and so he is a champion I
think we need to give him all the
ammunition we can to kind of get the
message out to the Congress and to the
science community that we really need we
need a much bigger push in this area so
thank for that and I think we're
pretty much in agreement on the goal and the
question is how do we get there could I
have the next question please yes our next
question is from Whitney your line is
now open
hi I think it's fair to say we're all
thinking about coronavirus right now and
what we need Dr. Koroshetz is for you
and the NIH to understand how deeply
connected this massive crisis is with
ME/CFS
I am very encouraged that Dr. Breen said
researchers are listening to our
concerns as you know many of us
developed ME/CFS after a viral trigger
often during widespread outbreaks like
this but we just don't have enough
research to show direct causes
personally my ME was triggered by H1N1
swine flu in 2009 and I feel as though
nobody cared that I never got better so
coronavirus has huge implications for
our community and this disease I was
thrilled to see the fast action and the
news that the NIH has already started
clinical trials on a potential vaccine
and while prevention is important what
will be done to study and treat the
people who may contract this virus and
remain ill from it like we have the
study Dr. Jason described is a great
model for what we should see with
coronavirus so my question is how do you
plan to include people with existing
ME/CFS and study links between ME and
any potential post-viral fatigue
syndromes that we could see resulting
from coronavirus
Walter do you mind if I take this
question
Joe were you going to take that question yeah
thank you I'm sorry I had some audio
problems so I think that right now that
as you mentioned that the emphasis
is on getting clinical trials started
with therapeutics that we already have
that were developed for other RNA
viruses that might be helpful in this
case and that's quickly then being
followed up with the vaccine studies
which have actually already started as
you mentioned which is really an
unprecedented time span I think that
that it's likely that we'll see studies
that are making connections to other
chronic diseases and particular chronic
viral diseases that will follow up on
that but to be honest the priority right
now are those two areas because of the
immediate needs in the country through
discussions that we've had with
researchers I think the kind of projects
that you mentioned will surely follow
but I think the priority and and the fact
that we're right in the middle of this
pandemic right now the priorities are
are the ones that I mentioned and I
anticipate and I know from talking to
researchers even in the
collaborative research centers where
they're recruiting patients that they're
thinking about these connections because
it's vitally important but it's going to
follow the therapeutics and vaccines
studies because that's where efforts
need to go right now in the short term
again if you want to see those
priorities that they're they're all
publicly available at the resources that
I mentioned earlier can I mention
something also along these lines um Lisa
Petrosen who is one of the experts on
mold M-O-L-D and how it might be really
causing this illness has been in
touch with quite a few patients
that have indicated to her that
they seem to be have gotten actually
sick over the last couple weeks and she
has begun to put together a survey which
I've had a chance to look over and she
will be distributing it very soon it's a
very comprehensive survey and it
actually would be kind of interesting to
actually collect some data on this issue
of both people with ME/CFS as well as
other illnesses and to see how they're
doing and then possibly be able to
readministor a questionnaire at a later
time to see if anyone who filled it out
initially now is sick and they weren't
sick the first time so both those who
are sick versus those who aren't could
be probably put together relatively
quickly and as I said that survey has
been almost developed and will be you
know will be issued very soon so I
think that is a very positive
development thank you very much yes I
just I hope that covid doesn't lead to
an increase in ME/CFS but I suspect
that as the caller mentioned it's
something that we should be prepared for
unfortunately at this point we don't
have a preventative therapy and then I'd
also also add that the intramural
program in ME/CFS is looking particularly
at folks who develop symptoms after
after a characteristic of a viral
infection so this idea of a viral
infection infectious mono lyme disease
for instance triggering immune response
that then goes on to ME/CFS is
front and center and folks minds but
I always hope that it won't happen with
covid-19 but I think we as you mentioned
we should be ready for that next
question please
Claudia Carerra your line is open
Dr. Koroshetz I'm glad to hear you
acknowledge the real scope of the
research that we will actually need to
achieve key outcomes like a treatment
like you said in the range of 500,000
researchers instead of a few dozens I
completely agree but what you and Dr.
Collins are currently doing is going to
take decades to get us there
and you have announced zero new funding
for ME/CFS on this call that is not how a
champion treats an urgent priority
especially in the middle of a crisis now
I want to say I spoke to you almost a
year ago on last year's spring community
call and at that time I identified
eight different existing NIH funding
mechanisms you could use to provide
set-aside funding for ME/CFS you said
several of these were good ideas and
that you would look into them I called
on you to secure at least one new
funding stream for ME research and to
hire at least one new admin to work on
the ME portfolio by the end of 2019
but now several months into 2020 you
have taken zero steps toward either of
these crucial capacity-building actions
yet you have been telling the media that
the NIH just like they're telling us
about how much the NIH cares about
ME/CFS you've been telling the media that
the NIH has doubled funding for ME/CFS
research in recent years I want to be
very clear for everyone on this call
about what has actually happened with
ME funding here throughout the 1990s
there were either two or three ME
research centers funded at all times and
the total level of funding in 1995 when
you take inflation into account was
almost the same as it is now just two
million dollars less in the last few
years you have not doubled any efforts
and resources at NIH you have reinstated
funding that was cut from ME research
in the early 2000
and we are barely getting more NIH
resources now than we were 25 years ago
that is not enough for ME but even
worse your FY 2021 projected spending
reveals you are not even planning to
gradually increase this amount year to
year because your projection for 2021
spending is exactly the same as what you
spent in 2019 so even you don't expect
that the centers and the PARs are you
going to put out are going to increase
your spending so look we all know that
science takes a long time even when you
are throwing everything you have at it
like with the coronavirus so at this
level of funding it will likely take us
another 30 years to get to the point of
having treatments for our community
maybe 50 that is unacceptable and if you
disagree with that time estimate Dr.
Koroshetz please do let us know it would be
great to hear when it is that you expect
that we will actually be reaching a
milestone of a treatment if we
follow the current path of 14 million
dollars a year in funding we refuse to
let another generation waste away in
dark rooms for decades especially
following this coronavirus and we need
biomarkers and treatments in the next
few years not the next few decades and
you and Dr. Collins need to do what it
takes to make that happen so my question
is about RFAs and PARS in the
October advocacy call five months ago
now Dr. Whittemore said we would need
RFAs to address several of the issues
that were raised in the Q&A yet you have
announced zero in this call and now of
course the corona crisis makes it
even more essential and urgent so you
have to quickly inject funding into ME
research and one way to do that is by
expanding the collaborative research
center network which is what you said
you wanted to do when you first
announced the current centers you said
this is a seed it is we know it's very
little we know it's small what has been
proposed by the CFSAC was 12 centers I
believe and you said it was going to be
expanded so do that you have to both
increase the funding for the three
existing centers and you have to fund an
additional cohort of centers and you have to do it
now to accommodate the studies we are going to
need of post-coronavirus development of
ME/CFS and i'll just say this is an
urgent crisis and you cannot squander
this opportunity to finally figure out
how this disease takes hold on our
bodies and you have the money to do it
eight billion dollars for coronavirus
okay now in that same october call Dr.
Whittemore said that the unfunded PARs
would be released soon hopefully very
soon but it has now been almost a year
since they were approved in the May
NINDS council meeting when you told the
council that these sorry Vicky Whittemore
told the council that these PARs
were urgently needed and intended as a
rapid measure while further RFAs were
being developed and it's been a year
since that point those PARs need to be
released yesterday and at least one of
them needs to include a call for
coronavirus related ME research in my
opinion I don't want to keep hearing
that you're getting held up by
coordinating with other Institutes or
getting NIH approval these do not even
have funding attached if Dr. Collins
cares about the community he will make
them happen like by the end of this
month so release what is ready now now
make whatever else needs to happen for
the rest happen in keeping with the
urgency of the current crisis and so my
question Dr. Koroshetz is when will the
first PARs finally be released when will
you increase funding for the current
CRCs
and when will you issue a new RFA to
fund additional centers and please don't
tell me soon I want specific months by
which you plan to take these urgent
steps thank you
well that was I think you know all very
cogent arguments and I think that if
you email us we'll get back to you with
the specifics in terms of the plans and
I just wanted to add for folks who don't
know that the vast majority of NIH
funding goes to what we call
investigator-initiated grants so three
times a year
anyone can write an NIH grant and they
get reviewed and then they get funded
depending on the meritorious nature of
the grant and the review panel who does
that is a review panel of ME/CFS experts
so we are always open for business for
applications now if we don't get
applications we cannot fund research our
problem at the current time is that the
number of applications is terribly
terribly small so the goal if we're
going to change the playing field we
need more people to work on ME/CFS and
that's a decision that every scientist
must make NIH cannot make that decision
for other people so I just want to
emphasize the grants that come in on
ME/CFS actually get funded at a rate that's
either the same or better than the
other grants that we see and as you
mentioned there were many years of very
poor funding but the funding situation
is much better now
so that a large number of really good
applications will get funded and all the
Institutes will bend over backwards to
fund good applications in ME/CFS research
and as you say there are other
mechanisms we can pull levers that we can pull
such as the consortium lever and
there you know we are looking carefully
at what are the levers to pull but if we
don't get the number of applications to
go up none of those levers are really
going to solve our problem
they are temporizing band-aids but we
really need and that's why we're on this
call that's why we put the effort in to
bring young scientists in to have
meetings about ME/CFS to try to encourage
people to come into the field and I
think that's what we need to do together
as a cohesive team and encouraging
folks to come into this area is the most
important thing at this point in time
and we do feel terrible that it's so
slow and we are open to any suggestions
to kind of move that faster so I
understand the anxiety and I agree with
it and we'll continue we're not
giving up I don't know if Dr. Jason if you
wanted to talk to folks a little bit
about why you decided to work on this
topic and maybe give some sense of you
know what it takes either for us
or others to motivate people to work on
ME/CFS sure I'm happy to say a few
words first thing as we know um you know
it's a very competitive process and
you know most grants do not get
funded for people like myself that
submit them so we need to recognize it's
challenging and one has to be really
persistent to ultimately get the funding
and I do think that
this is such an unusual
opportunity to understand as you know we
heard this call
that there are immune markers and
possibilities of understanding this
chronic illness that could really have
implications for all types of different
types of coronaviruses in that I think
the reason this is such a critical time
for investigators like myself and others
from outside of NIH to get interested in
this is because we know that a certain
percentage of people based on some of
the Australian research from multiple
viruses and different types of pathogens
there is a certain percentage of people who
don't recover I'm particularly
interested in the Epstein-Barr Virus but
we know that some people seem to
continue to be impaired six months a
year several years later and into their
lifespan so what's happening right now
is such unique opportunity to basically
find a cohort and to sort of see the
manifestation of the immune system
because what we can find from
coronavirus might have incredible
implications for um you know the types
of other viruses or other types of
precipitants that might be causing this
illness so yes this is a time of unequaled
opportunities for researchers to get
involved and I applaud
the individuals who kind of talk
about RFAs you know really are probably
being phased out to other types of
mechanisms that are going to be PARs
and those possibly could be targeted for
all types of incredibly important work
going forward so yes I do think that
this is an important time for
us to be working on these issues and I
do think that the insights we learn from
this basic ME/CFS research will have
incredible implications for many other
types of illnesses um that are affecting
our citizens today
thank you very much Alissa
Yes so we're at the top of the hour
so we're going to go ahead and close the
call I apologize that we weren't able to
get to all of your questions so those of
you who might still be waiting to ask a
question you can feel free to send them
to braininfo@ninds.nih.gov or
simply go to the NIH ME/CFS website and
click on contact us to submit those a
reminder that a recording and transcript
of the call will be posted to the NIH
ME/CFS website soon and I'd also like to
remind you about our listserv for
updates from NIH to be added to this
list serv please visit the NIH
ME/CFS website at www.nih.gov/mecfs
1378
01:07:28,500 --> 01:07:33,420
and click on join our listserv at the
bottom of the left sidebar thanks to all
of you for an informative and thoughtful
discussion we wish all of you good
health and a good afternoon and thanks
very much Dr. Jason for joining us and I
hope as Alissa said everyone please be
safe out there thank you that concludes
today's call you may disconnect at this
time host please stand by for your line
count
