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>>Dr. Nancy Lee: This is a panel that we're having for five
organizations that are committed to making
a difference in chronic fatigue syndrome,
ME -- myalgic encephalopathy.
I'd just like before we start to make a couple
of remarks, very brief.
The first is -- a question has been raised several
times for the inability for foreign scientists,
foreign attendees to attend.
Indeed last time, we had a scientist from Norway who
participated, or who attended;
that was at the Holiday Inn, they let anybody in.
If you all remember, the ones that were there
you didn't have to be escorted to the bathroom,
go through security check when you walked
in everyday, wear an armband -- I mean, a wristband.
So that is the reason it's always been the case,
at least for some time now that to get entry into
this building as it's more difficult for someone who
does not have a U.S. passport.
Yes, Eileen.
>>Eileen Holderman: I'm glad you raised that issue
because I tried to think about the times in the past,
we've had like Kathy Row here from Australia presenting --
>>Dr. Nancy Lee: Right, and those things --
>>Eileen Holderman: -- [unintelligible] a lot
of people, like --
>>Dr. Nancy Lee: You can get them in,
but it takes a month.
>>Eileen Holderman: Okay.
>>Dr. Nancy Lee: So, we --
>>Eileen Holderman: Would not --
>>Dr. Nancy Lee: -- did not have the advance notice,
and we really don't have adequate staff to --
if we know in advance and we can do it,
we will try and arrange this, but --
>>Eileen Holderman: Okay.
>>Dr. Nancy Lee: -- we didn't have the capacity.
You know, there are advantages
and disadvantages to not having the meeting here.
I got a lot of grief last time for not having it here.
There are advantages and disadvantages for --
>>Eileen Holderman: Yeah.
>>Dr. Nancy Lee: -- both places, and one of them is you all
are free to move around and come and go much more
easily and we didn't have to limit --
>>Eileen Holderman: Yeah.
>>Dr. Nancy Lee: -- foreign visitors.
>>Eileen Holderman: But with the 30-day notice, it's possible.
>>Dr. Nancy Lee: It's possible.
>>Eileen Holderman: Great.
>>Dr. Nancy Lee: But that's difficult.
>>Eileen Holderman: Yeah.
>>Dr. Nancy Lee: It's difficult.
>>Eileen Holderman: Okay.
>>Dr. Nancy Lee: But it's not --
>>Eileen Holderman: But possible.
>>Dr. Nancy Lee: -- not something that we
routinely reject, we just need --
>>Eileen Holderman: Yeah.
>>Dr. Nancy Lee: -- to be able to plan that in advance.
>>Eileen Holderman: Thank you.
>>Dr. Nancy Lee: And the second comment I'd like to make
is that I just want everyone to know that
every one of the people up here,
both our non-federal committee members
and our federal committee members are committed
to this topic.
We've worked hard; some people have worked
for many years, and we are very committed to this
topic, and that's why we're here.
We have several of our government members who
are personally affected by CFS.
We are very committed to this,
or we wouldn't be here.
[applause]
With that said, let us begin.
Kim McCleary will start and introduce each of you
-- introduce yourselves, and tell us about your organization.
>>Kim McCleary: Thank you Nancy,
and thank you to the committee for the opportunity to sit
here with friends and colleagues at this table and have this time
to share with you updates on our organizations,
because I think it's very complimentary
to the discussion that we've gotten in to listen into,
particularly this morning on the funding opportunities.
So I am the president and CEO of
the CFIDS Association of America.
We are marking our 25th year of service this year,
and rather than focus on the history and what we've
done over 25 years, I'm going to really limit
in my comments to what we're doing current,
because I think that's more relevant
to the information I would like all of you to have,
as well as the people in the room,
and listening by webcast and audiocast.
So, our organization has been a lot of different
things over the years.
There are so many needs that this community has,
and filling those needs or trying to meet those needs
is a constant challenge no matter where you focus.
But over the last four years,
with the addition of a full time scientific director,
Dr. Suzanne Vernon, to our staff, we have really narrowed
our focus to try to stimulate the research, and to act
in a way that Nancy summed up beautifully earlier,
to build, nurture and collaborate with
the scientific community, so that there is more robust,
both in terms of the number of topics and also
the rigor of the research being conducting on CFS.
In earlier this year, we launched
the Research Institute Without Walls, and that's kind of where
I'm going to focus today, and now we are focused
on identifying disease modifying treatment
for CFS rather than a whole gamut of research,
we've really narrowed it on that as an area that
nobody else is really looking at very closely
right now, so our research is hopefully all feeding
into building a pipeline that then we'll be working
more closely with FDA to put products into and evaluate.
And I just want to say that there's been a lot
of confusion, and that's always our responsibility,
to make sure that there's not confusion about the
organization and its role for in-patient advocacy,
and what we're really doing is expressing our
advocacy for patients with this through our research
program, so we sort of struggle with the labels
of who -- which one of us is patient advocates;
I think all of us in this room are patient
advocates, or we wouldn't be here, as Nancy said.
So our research program being sort of being
the centerpiece of what we're doing,
just a little bit of history; in 2009-2010,
we had six grantees that were able to turn $637,
000 of seed funding into follow-on grants from
the National Institutes of Health
and the Department of Defense into grants totaling more
than $5 million, and I think that's the model that
we've been hearing about this morning,
is having researchers with the kind of pilot data,
and early studies that can go on to compete well
and successfully in a very tight NIH process,
and also with the other funding agencies that make
investigator-initiated awards.
We've heard a lot this morning about the need
for registries and repositories,
and we recognize that need as well,
and in 2010 we launched the Solve CFS Biobank,
with the assistants of an infrastructure provided by
Genetic Alliance, and today we have enrolled and consented
482 participants that includes individuals
with well-characterized CFS,
many of them coming through the clinicians
who've either served on this committee
or presented to this committee.
Also, contact controls and health controls,
because those are so important in doing
research, having the appropriate control subjects.
And since we launched the Solve CFS Biobank
in March of 2010, we've launched now nine research
projects, and just by way of comparison in that same
amount of time, NIH has launched seven
CFS-specific research projects,
so even at our modest scale of resources,
I think we're doing pretty well now that we have that
research resource available to the broader
scientific community, and a way for patients
to participate in these studies.
Last year to help us refine our research
approach, we formed a diverse scientific
advisory board, and I don't have enough time
to go through their names, but their tiny little
pictures are down there, and some of those people
you will recognize as people who've either
served on this committee or been involved
in the state of the knowledge meeting,
really bringing diverse scientific expertise from
top institutions around the country,
and also outside of the country with our Canadian
colleague Gordon Broderick.
And as I said, we launched the Research Institute
Without Walls on February 23rd.
And this is a terribly busy slide that I could
spend of my colleagues' time going through,
but I just wanted to just bring out a couple
of the points, and it's all centered as you can see
there on the Solve CFS Biobank,
because the investigators whose pictures are on
the left hand side, Dane Cook, who recognize at the table
here, Dr. Row who was seated at this table
yesterday, and Marvin Medow at New York Medical College;
their participants and their studies are clinical
populations, and they will be also enrolled in the biobank.
And then all the folks on the right hand side will
be using their samples in clinical information
to conduct their studies, and we hope that this will
continue to grow and build,
and that I'll need several slides at some point
to illustrate how many projects we have,
both feeding in an coming back out of the Solve CFS Biobank.
Many of these are focused on identifying biomarkers
or consistent evidence -- subjective evidence that
we can then go on to push further down the pipeline
for diagnostics and treatments.
Drug repurposing was something that Dr. Maier
brought up in her talk, and we're working with
a small company called Bio Vista [phonetic sp] to
look at some of the drugs that have already been
approved for other indications and what
utility they might have on CFS.
And these are non-obvious drugs;
we're not just looking at the kinds of medicines
that are typically in the arsenal for symptom
relief, if we're looking more deeply at some
of the mechanisms of action and how they might
work in CFS.
And then you can see epigenetics,
I was at an NIH meeting on Tuesday and heard
the National Human Genome Research Institute director
talk about just the value of epigenetics
and complex diseases, and we're delighted to have
a young investigator, Patrick McAllen,
looking at that and CFS for the first time.
Dane Cook and Peter Rowe and Marvin Medow with
their tremendous expertise in this population,
and bringing their different studies
together, and I would just say that Dane's study that
he's doing to try and bring together some
of the findings on the post-exertional malaise
and blood biomarkers that the lights
at the University of Utah have done,
and functional MRI imaging wouldn't have been
possible without the computational advances
that have been made to be able to handle large data
sets with complex data, and just how important
that is in advancing our understanding in some
of these tools will help move the field forward.
We're also pairing this with communications;
we know how important it is for the community
of people whose lives are daily impacted by this
illness to know what's going on,
we have a long tradition of print publications
in the seat that's chronicled that many of you have
seen, and now we do just a semi-annual newsletter,
because so much is available online,
and I do have some copies of our latest issue that
I'd be delighted to not to take back to Charlotte
with me tonight.
We also launched a new research focus website last year,
Research1st.com, and I made this slide on Wednesday,
I think of last week, and I think we have 212 posts
up there on research-related topics;
many of them written by guest experts,
people around the table in fact.
We also published two e-newsletters,
the Research1st News is a monthly digest of all
the latest research and policy news;
we've done a whole series of webinar programs
and will actually be having one -- we're scheduling
it now at the end of July on post-exertional malaise,
because post-exertional relapse,
because that is such a big topic of interest,
both in the scientific community and also
the patient community.
And we have an active social media presence
in Facebook, Twitter and YouTube.
And then we've taken our models,
as Bernie [phonetic sp] was nice to point out,
we've learned about how to structure our research
program from organizations like the Michael J. Fox Foundation
and the Mile and Repair Foundation
and the Susan B. Love Army of Women, and now we need to take
those models and figure out how they raise money
to support those illnesses so that we can meet the needs
and expand the research in a very vibrant way.
And I've pictured Bernie's beautiful and comparable
daughter, Laura Hilenbran [phonetic sp] here because
we are so grateful to her for the tremendous support
she's provided to help up get this Research
Institute Without Walls launch this year.
And I would love to be able to tell you the
stories that the other catalysts pictured there
on the right, and it's just been, you know,
great coming together of people's interests
and really resonating throughout the community
that this now our focus and what
we are championing.
And we're beginning to host some regional events
that we call Catalyst Café events throughout
the country so that we can really bring our message
to individuals and use some tools other than
the sort of impersonal imperfect Internet
to do that, and hoping to reach more circles of people
to get them involved in the cause.
And I think I might have not gone too badly over my
five minutes, but I look forward to taking your questions.
>>Dr. Nancy Lee: Thank you very much.
Our next [inaudible] --
>>Mary Dimick: Thank you.
Will the slides be put up, or -- there they are.
Thank you.
My name's Mary Dimick [phonetic sp],
and I'm speaking on Denise Lopez-Majano
and Speak Up About ME.
As the mother of two young men who became sick during
their school years, Denise had to face the challenges
every patient a school-age child faces: problems with school,
being able to get the support that they need,
increased isolation -- social isolation,
and other such challenges.
She became determined to find a way to help her
son, and out of that determination was born
Speak Up About ME, to help others get support to work
with the school systems.
She wanted to be here, obviously,
to speak with you today.
She was unable to because her sons are too ill
to be able to be here for more than a day,
and that's a challenge that so many in this
community face trying to advocate for themselves
when they're too sick or too busy taking care
of their families.
As I said previously, Speak Up About ME was born
out of a determination to empower young people
and their families to better deal with the unique
challenges that they all face because of the age
that they're at and what they're dealing
with in their lives.
She does this since Speak Up About ME does this
in three ways, first by fostering sharing
of knowledge and information that addresses the unique
challenges that these young patients face.
Examples of that kind of information are the kinds
of accommodations that schools should make
and that they are entitled to.
We heard quite a bit about that yesterday on the panel;
I won't go into that with too much
more detail, except to say that she has talked to me about
examples of where children are being asked to go into
lower grade, lower level classes that are not
as challenging from an intellectual perspective,
because the schools feel that's all they can handle.
Another one is connecting parents with advocates
that can help with them with this school,
people that have done it before that can help
people who are just coming into it.
How the SSDI and the SSI process works,
especially with school-age children,
especially with people who will never have a work history.
Use of special needs, trusts,
and other mechanisms to be able to plan
for financial, because as you know,
if you've never worked, you can only have about
2- or $3,000, in order to qualify for benefits,
so what can you do to help your [unintelligible] families?
And then approaches to deal with the socialized isolation.
The second way that Speak Up about ME helps
to empower young people and their families
is by supporting and connecting people.
It's very hard for people to -- hard for patients
to find someone who's been through similar
circumstances, and it can be very helpful when
you find out and meet somebody who has gone exactly
through what you are experiencing.
She spoke about being able to connect to mothers who
had two daughters, both with ME,
one of them already had a toddler,
and the other was going through pregnancy,
and for those two mother to be able to talk to each
other about that experience;
in fact there's somebody in the audience today who
will be able to connected through that experience as well.
And then the third way about Speak Up About ME
helps is to give them the confidence.
It's intimidating for any parent, any patient,
to face health care providers and school
systems, to tell them they're really not sick,
they just need to get with it, they just need to try,
and to give them the confidence to say,
"No, I really am sick, I need this kind of support from you."
Speak Up About ME is not located in a certain
location; it's really a grassroots coalition
or network of people that are focused on issues that
specifically affect young people with ME/CFS.
And again, like we said, or like I said in the
previous slide, issues around how to deal with
schools, what doctors are known to help people,
pediatrics, how to counteract the stigma
of ME/CFS, especially that these patients can face
within schools and with their peers.
A particular concern to Denise is how these
patients make up for so much lost time that
they've had during their formative years than when
they would be developing life skills and other
kinds of social skills.
Predominately, the network is focused within
the U.S., but obviously, there's other opportunities
to be able to share information with other school systems,
other advocates of other parts of the world, and Denise has
established contact with some of those individuals to start
to understand what they're doing and what's working
within their population. Why do we do this?
Because this is such an underserved population;
you heard yesterday how underserved this
population is and how unique their needs
are in terms of getting services and support for what
they're dealing with and facing.
I believe it was Faith, the woman that spoke
yesterday with a patient panel that spoke about
the regional group that meets.
It is regional group from the middle Atlantic that
meets a couple of times a year.
I've actually had the good fortune to be able to go
there myself and to see how that really works,
and it's a chance, as she said,
for these patients to be able to come together
in a way that everybody understands what they're
dealing with, and they don't have to explain
themselves when they have to lie down,
and that has a big impact on them.
And also, the parents get to support each other
and understand what's working, and it's an excellent
model that could easily be replicated in other parts
of the country to help school age children.
And Speak Up About ME maintains an ongoing list
of patients who have early onset.
Not all of those patients are still under the age
of 23, but for anybody that did get ME/CFS under
the age of 23, she does maintain a list.
Currently there are about 120 people on that list.
The other thing that she wanted me to share
with you is a partnership that is going on between
herself and Phoenix Rising to develop a survey
to look at Social Security issues and Social Security
disability for people with chronic fatigue syndrome.
And Cory [phonetic sp] will be in a better
position to answer questions on that,
but I just want to give you the highlights of it.
As of May 31st, there's about a 168 completed survey responses.
The kinds of things that they're trying to learn
through that are what factors ultimately result
in a successful application to SSI or SSDI.
And how has the length to final determination
changed over the years?
That will be coming back to you at a later time
when they have a report that they expect to have
that ready by the fall of 2012.
And that's it, thank you very much.
>>Dr. Nancy Lee: Thank you very much.
Excuse me.
The next organization is Pandora,
and Marley Silverman is going to tell us about Pandora.
>>Marley Silverman: Thank you so much.
Thank you, Dr. Nancy Lee and the others for this opportunity.
I'm going to be speaking of course
on behalf of Pandora.
Pandora is very dear to me;
I'm originally the founder of Pandora,
and I started Pandora basically out
of a self-necessity.
I was trying to find the solutions,
and I was trying to find better resources to take
care of my health at the time that I became with ill with CFS.
Pandora has a unique niche;
we actually embrace -- we embrace the concept
of [unintelligible] the [unintelligible] disease,
and within this concept, we embrace chronic lyme
disease, ME/CFS, fibromyalgia,
multiple chemical sensitivities
and environmental illnesses, and Gulf War illnesses.
And the reason we have done this -- we approached
this from a quality of life issue,
because most of the support groups that
we supported over the years, patients had these
comorbidities overlapping constantly.
People would come in having ME/CFS and two years later,
diagnosis of fibromyalgia.
People would come in with Gulf War syndrome,
but primarily had major fibromyalgia issues
and multiple chemical sensitivities issue.
So we realize that from the quality of life issue,
it would be a much better approach if we embrace
the organization under this umbrella.
We have been extremely successful,
even to the point that the NEI center actually in New Jersey,
the legislate in New Jersey actually passed
a standing resolution, pushing for the NEI center, so I'm very
pleased to report that.
Next slide -- whoops -- go back.
Our main advocacy project over the years has been
the Advocate Extraordinaire Leadership program.
This is a program that started, again,
as a grassroots program over the years,
and in 2007 at the kickoff for the IACFS and ME
conference, which we sponsored,
and we were the host organization with some
grants from the community, including from
the [unintelligible] association mark,
[unintelligible] pharma, and other committed --
coastal construction -- we kick off the program,
and it's been extremely successful.
As a matter of fact, a lot of the patients that
you see here testifying, are here supported by Pandora
and by the Advocates Extraordinaire Program,
including the Speak Up About ME.
Other Pandora projects over the years have been
the Empty Chair Project, Pediatric Pennies,
I Need A Hero Project, Quality of Life.
The Quality of Life Project is actually
a little kind of local thing that we do,
where we actually go to people's homes and help
them to declare their homes.
We help them to organize their finances and things
like that, it's really a one-to-one,
and it's been extremely successful,
but limited resources that we have, of course.
The other programs, again, has been the Speak Up
About ME, [unintelligible],
Lyme and Aid, Bringing Ryan Home,
which was also a project that we,
for lack of better words, step up to the plate,
because this child was taken away from his
parents, and the mother was accused of munchausen
syndrome by proxy, eventually
[unintelligible] by proxy, it eventually charged with
failure to provide primary care,
which means because she couldn't find a primary
care physician in [unintelligible] County,
North Carolina, Nashville, they charged her with that.
It was the most ridiculous thing I've ever seen,
but anyway, the bottom line is that particular
family is now in a hole over $30,
000 in lawyer fees, and financially is still
fighting to find a primary physician to take care
of their child.
And so this is why we keep coming back to you here,
stressing the quality of life issues is an everyday
thing that we suffer every single day.
Obviously we have also supported the Coalition for ME/CFS.
Again, it's a group of organizations;
together we have eight organizations right now,
and the goal of the coalition is to jointly
address these main hardcore issues that we
are facing every day from funding to research
to FDA, stakeholder's meetings and so forth,
and we're being extremely successful,
because now other organization are also
joining us, even on [unintelligible] within
the coalition by joining the advocacy train,
and moving forward with the thing,
and I'm very grateful for Mary for helping us with
the join request letter that we had,
which we presented yesterday, was a very,
very powerful letter, I think,
because it was a united front from all of us,
and that's the message that was delivered here yesterday.
Over the years, we have given grants to Nancy
Klimas, Gordon Broderick, the Vermont CFIDS
Association, VA Foundation of South Florida,
the National Fibromyalgia Association,
Dr. John Chia, Michael Antoni from the University
of Miami, and also para la Fibromyalgia y el Sindrome
de Fatiga Cronica in Spain.
The grants we have received from Coastal
Construction, Forest Laboratories,
HHV 6 Foundation, Purdue Phrama, Pro-Health,
Mark Iverson, and the Silverman,
Oren and Mayer families.
And more importantly, through Chase Community
Giving, we were the very first organization to win
$20,000 from the program and also CITGO for Fueling for Good.
We have a position, we stated,
as we presented earlier in our testimony,
the issues about the NCHS; it's very important that
the proposal for the coalition for the ME/CFS
be addressed, and as soon as possible,
because ICD-10-CM was due to be implemented soon,
has been postponed but has to be addressed,
and this committee, really,
is your recommendation; you need to address that.
And of course the CFS program also at the CDC --
all those things are extremely important to us,
but you already know about that,
so I'm just going to go right through it so other
colleagues can have also the opportunities,
the same thing with the NIH.
I do have one special thing that I would like to address.
The Social Security, I would like -- or Pandora
would like that Social Security considers
the possibility of placing severe ME/CFS patients
on the list of compassionate allowances.
I think that because of the neurological findings
of ME/CFS -- if we have a way to identify the severe
patient, it should be allowed under that
compassionate allowance, and what that does is you
go to the process very quickly.
The administrative law judge is and the person
at Social Security knows how to handle you,
in three or four, five, six months, you're done.
Move on, next, and that person then either has
access to Medicaid or Medicare,
which is extremely important.
Ten years in counting, hooray;
we have been 10 years in this business.
On July 1st will be our tenth anniversary,
and I'm happy to share this with you.
Thank you so much.
>>Dr. Nancy Lee: Our next speaker is Cort Johnson,
from Phoenix Rising.
>>Cort Johnson: I'm President of Phoenix
Rising and the founder of Phoenix Rising.
Phoenix Rising is now a non-profit corporation.
In the ancient myths, the phoenix is a powerful
symbol of renewal as it rises out of its ashes
to new beginnings.
It's that possibility of renewal that the patient,
community, and even at the disorder level,
that the staff and volunteers of Phoenix
Rising are committed to producing.
Phoenix Rising is different from other
organization, working entirely online,
we think of ourselves as the world's largest support group.
And as such, we are committed to providing
information, tools, and opportunities that people
with ME/CFS can use to make a difference in their lives.
Currently, we empower people by providing
accurate information in the controversial field
and tools to facilitate the free flow of
information, and break up the isolation present
in this disorder.
With over 1,000 articles and pages on our website
and over 5,000 registered members, and over 260,
000 posts on our forums, Phoenix Rising presents
an information resource second to none.
At any given moment, from 1- to 200 hundred people
around the world are scanning Phoenix Rising's
forums, website, chatrooms, blogs,
articles, and newsletters for information on how
to get well.
We changed dramatically over time;
it began in 2004 as one person's attempt to build
and ME/CFS knowledge base, Phoenix Rising has become
a diverse organization committed to using
the power of the patient community to produce change.
Recent patient-driven projects Phoenix Rising
has supported include hosting the ME analysis
of the Pace trial which uncovered major errors
in both methodology and analysis.
Collaborating with the coalition for ME/CFS
to produce a critique and provide recommendations
for the ICD-10 document.
Working with Speaking Up About ME to produce
the first comprehensive disability survey
in the ME/CFS community.
And most recently, Phoenix Rising supported
the effort to produce a stakeholder's meeting
to achieve, to advance treatment options at the FDA.
But that's just the beginning.
Phoenix Rising school is nothing less than
transforming the way these chronic illnesses
are supported on the web.
And in doing so, to build strong communities capable
of achieving change.
Judy in Miami, for instance, doesn't know anyone in her area
she can go and talk to about CFS.
But what she doesn't know is that she is actually
surrounded by patients and their supporters and
support groups, and good doctors are available.
She doesn't know this because that information
is either missing or is haphazardly presented
on the web.
By putting patients, doctors, volunteers,
support groups, and research groups
on the map, Phoenix Rising's Community Rising Mashup
Program will allow Judy to build vital new
relationships, find support options that she
didn't know where possible,
help her find the best doctors in her area,
and enroll in local research efforts.
Meanwhile, Mary has seen six practitioners,
Joe has seen 10, and both have spent more time
and money than they could have imagined simply trying
to find someone who understands this illness.
But what if with one click they could see which
practitioners in their area were the most
effective, or which were the best fit for their
budget, or which just happen to be really good
at solving their dizziness, or pain,
or sleep problems.
Phoenix Rising's Physician Review Program will not
only determine which practitioners are the most
effective, but it will identify which types
of practitioners are, how important experience
is in treating this illness, who gives patients the most
*** for the buck, and more.
In short, will help you decide who you should see
to get you the best results.
In the same vein, Phoenix Rising's Treatment Review
Program will not only inform patients
of the best treatment options, but will also,
as we produce and send out reports,
inform medical doctors of options they are unaware of.
These are just some of the programs that Phoenix
Rising will use to build a virtual community that
empowers people with ME/CFS around the world.
[applause]
>>Dr. Nancy Lee: Thank you very much.
Our final speaker will be Patty Strunck with the New
Jersey CFIDS Association, and after that we'll have
time for comment and discussion with our panel.
Ms. Strunck.
>>>>Patty Strunck: Hi.
My name is Patty Strunck and I'm from New Jersey CFS Association.
Okay.
Although we are --
>>Cort Johnson: Oh, these are the slides that
I forgot to do.
[laughter]
>>Dr. Nancy Lee: We'll still post them.
>>Cort Johnson: Aren't these nice?
[applause]
[laughter]
>>Cort Johnson: It's great stuff.
I've got them all on there.
[laughter]
>>Cort Johnson: I thought there were only five. Yes.
[laughter]
>>Dr. Nancy Lee: There were many.
>>Cort Johnson: There you go.
Now you can start.
[laughter]
>>Patty Strunck: Although our address is Florham Park,
we are actually all over the state of New Jersey
from the -- right near New York City
to the very end by Atlantic City.
So our membership and our board members are from all
over the state of New Jersey.
We are 501c nonprofit organization that was
established in 1995.
We support patients and their families.
We disseminate reliable information
about the illness.
We facilitate communication between
health care providers and their patients.
We promote research into the cause,
diagnosis and treatment, and cure of ME/CFS.
We educate patients, nurses,
and others in contact with those with ME/CFS.
One of the ways that we educate physicians,
nurses, and others is by going to various,
very different -- I'm sorry -- I'm having
a moment there.
Various, the different, let me see my notes here --
conferences that they hold.
I'll be getting back to that later.
We have support groups and our support groups meet
throughout the state in various locations such as
libraries and hospitals.
Some of our support groups no longer meet because
the support group leader is too ill to run the support
group, or can only hold phone support.
So, you know, we try to do the best that we can,
but when all of our -- the support group leaders are
so sick themselves, that's the best we can do.
We have a helpline.
Our helpline is staffed.
It's a, it's a toll free number and we take about
200, well 263 calls were taken in the past
until May 31.
So that may not seem like a lot of phone calls, but it is.
Trust me.
I'm on the helpline. I take calls once a week.
Most of those phone calls are just people that want
access to our physician referral list.
That's really easy.
I could just shoot them an email and send them
our doctor referral list.
That's great, but a lot of times that person wants
and needs a shoulder to -- someone to listen
to and you're giving them an hour or more of your time.
You're giving them counseling and that's
really -- that's really one of the reasons why
I do that job.
It's rewarding.
When you're listening to somebody that was just
diagnosed or doesn't know what to do because their
family is not understanding and they need help.
They don't know where to turn to,
and you can give them some insight and information,
and just listening is what they need at that point.
So that's one of the reasons why I do that job.
It's rewarding to be on that committee.
Our website is full of information that you can
turn to, and actually, some of the information
that we have on there is two local doctors.
One of them is Dr. Podell in Summit, New Jersey,
and Dr. Ben Natelson.
Even though he's in Manhattan,
a lot of our patients go into New York
to see physicians -- are both participating in CDC
research, so that's really good information that we have.
We have a physician and attorney referral list.
The only way to access that is by calling
our helpline.
We don't have that available just online.
You have to call the helpline to get that information.
We publish a journal every year.
Actually, it's supposed to be twice a year that
we publish that.
And we have a lending library.
Our library has over -- it has 263 books, medical journals.
It's the most extensive private collection
of ME/CFS literature available,
and it also has audio, video,
and other literature that's available.
The only thing that we charge is just a mailing fee.
So that's available to all of our members.
We hold a medical conference every year
in the fall.
Last year we had CDC's Dr. Beth Unger come
and speak, and that was very well attended,
and everybody was very excited that she was able
to come and speak at our conference.
The conference that we are holding this year,
we are having Dr. Lucinda Bateman come and speak
about ME/CFS treatment, signs, and progress,
and reasons for optimism.
Natalia Palacios [phonetic sp] is going to speak
about epidemiology in a large study of female nurses.
Wilfred Van Gorp is going to speak about evaluating
the brain effects of chronic fatigue syndrome
in children, adolescent, and adults,
and Dr. Susan Levine is going to speak about
forming successful clinical research
collaboration to conquer the enigma of CFS.
Did I get that right? Okay.
[laughs] Thank you.
Some of the benefits that we offer to patients
and families are, we offer a high school scholarship.
It's the only one of its kind in the United States
that a support group, that a group offers.
The student has to be not just educationally
qualified, but financially qualified to receive
that scholarship.
We were the first group of its kind to offer
a medical school scholarship.
The student has to attend one of the medical schools
in New Jersey and they have to, initially,
they had to be a first year student.
We opened it up to all years.
Now, it's not just, it's not just us.
We were the model for this medical school scholarship.
Vermont and Marley [unintelligible] Pandora
is offering it also.
>>Dr. Nancy Lee: One minute please.
>>Patty Strunck: Okay.
We offer education accommodation help that
we have had some of our board members sit in on IEP
meetings to offer help, assisting parents with
accommodating their student.
That was the very topic of yesterday's meeting,
offering assistance, helping students through,
through school problems.
We have had several different board members
sit in and offer assistance because
the price that you have to pay to an attorney
or an educational assistant is astronomical, so we have had
board members that have helped with that.
We talked about our conference and the conference.
We have CMEs for physicians.
We have four informational fact sheets and coming
soon is a new one, which is CFS information
for school nurses and school personnel.
And when we get that one, I will be sure that
everyone here gets a copy of it.
And this is just our numbers,
how many phone calls, and how much we have awarded.
Every May, our governor -- I think I'm ahead
of myself here.
We have a consensus manual that was published
in 2002 for physicians.
We are hoping to update that manual with
the pediatric manual.
And every May, Governor Christie declares May
to be Chronic Fatigue Syndrome Awareness Month.
And this our -- okay, this our --
>>Dr. Nancy Lee: Okay, I think we should probably just,
can we move forward?
>>Patty Strunck: Okay, thank you very much --
>>Dr. Nancy Lee: Yes, thank you very much.
>>Patty Strunck: -- for giving me the opportunity to speak.
>>Dr. Nancy Lee: I want again thank all five
organizations for this.
Just so everyone knows, they came here on their
own expense, and we greatly appreciate that.
We -- there were many reasons we thought this
was a great idea, and we hope to continue with
this, and in November, have additional panels
of organizations -- of organizations committed
to bettering the situation for chronic fatigue
syndrome patients.
We're also, I think I discussed this briefly
in last November's meeting that we have to come up
with -- we are required to renew our charter every
two years, and I think it would be fabulous to add
membership from these organizations.
There are several other advisory committees to HHS
which have organizational members as nonvoting
liaison representatives.
So they wouldn't be able to vote,
but they would be able to sit with us to speak
when called upon.
They wouldn't have to sign up for the public comment
that time would be available to others.
And they would be able to participate
in our discussions.
I think this is a great idea,
and we're going to move forward with that.
The charter process requires public comment
and some careful thought.
We have a requirement to get this done,
at least the initial draft, by this fall.
And so I don't think we'll be able to have huge numbers.
We're talking three or four organizations.
Our thoughts are that those organizations would
have a term just like our membership have terms
so that we -- even though we're only able to have
three or four the first time,
then we'll be able to replace those
organizations over time with other ones.
These are the thoughts that we have.
We haven't gotten further in the details,
and of course, this is not done until it's done.
But I think there is a lot of commitment on our side
to go forward with this idea.
So let me open the discussion up to our panel.
Yes, Adrian.
>>Dr. Adrian Casillas: I have a question for Cort and Patty.
What, you refer patients to doctors,
to lawyers as well.
What criteria do you all use in selecting
the physicians that will be on your referral list?
>>Patty Strunck: In New Jersey we go by our own
patients' recommendations.
So we have people that have referred physicians
to us, and then we have a form that we send
to the physician to fill out.
And if the physician wants to be on our referral
list, they fill it out, and return it to us.
So we don't do it without the physicians' knowledge.
>>Dr. Adrian Casillas: And do you pick any specific
specialty or certification?
>>Patty Strunck: We have all specialties.
We have lots of specialties on our list.
>>Dr. Adrian Casillas: Okay. Thank you. Cort.
>>Cort Johnson: We don't have a physician referral list.
We are, we are working on a physician review list,
in which the patients will review the physicians,
and they'll be able, hopefully they'll be able
to weed out the better physicians from the not
as good physicians.
That's one of our goals is to try and get people
the best physicians and stay away from physicians that
aren't good or do harm.
>>Dr. Adrian Casillas: And you'll rely on the patient
description of their care for the basis of your decisions.
>>Cort Johnson: Yes.
We'll have a -- we have a kind of comprehensive survey.
So we'll ask the patient to review the physician
on all sorts of areas, and hopefully we'll be able
to get some good data from that.
>>Dr. Adrian Casillas: Thank you.
>>Marley Silverman: In the case of Pandora,
it's pretty much patient referral as well.
We have actually, and we kind of follow the same process.
We call the physician to see if he still wants
to be listed.
Because we have cases in the past where patients
refer physicians to us, and we had phone calls
from physicians saying please don't put us
on your list because we cannot accommodate
the type of patient care that requires,
time-wise and money-wise.
It's not really a perfect science,
but we strive to really include physicians that
really want to take care of the ME/CFS patients
or any IDS patients.
Anybody wants to comment?
>>Dr. Nancy Lee: Lisa.
>>Dr. Lisa Corbin: I have a comment on a question.
First of all, what struck me,
and I hope it struck others as well,
is how much collaboration is going on between
the five groups here today.
And I think that's spectacular because
a lot of times, it seems that when there's a cause,
that there are groups that wind up competing with
each other for limited funding,
and so I just wanted to bring that up.
That gives me a lot of hope.
[applause]
And just a question for CFIDS Association.
I'm intrigued by the SolveCFS BioBank,
and a lot of discussion that I've heard today.
How do patients get their bio into your bank?
>>Kim McCleary: We, our startup study was
very narrowly described.
We were looking for a very well characterized
patients with acute onset and they must have
the post-exertional relapse.
Now we've broadened it out because we know that
different studies will require different subtypes
or, you know, overlapping conditions as well.
So just call our office.
BioBank@CFIDS.org will also get an email response
from Gloria Smith who is our BioBank coordinator,
and we go through a full consent process.
The initial part is a registry.
So they register and provide all their clinical
data, which is an extensive capture of all
kinds of medical history and as much data
as the patient has access to.
And then, as we enroll studies,
we can make sure that we have the right sample
at the right time for the study that's being done.
It's a customized kit that goes out
to the individual, and they have the blood draw or the buccal
swab collection at the time that we need it.
And then, we capture new information at that time
so it's all updated.
And our hope is that we will be able to expand
well beyond nearly 500 people that we have now,
and also include longitudinal data over
time so that we can do the kind of secondary analyses
that Dr. Maier was talking about earlier because
we think this is such a rich source of both discovery
and also validation for other studies that
are going on in a very cost effective way for both
the investigator and population.
>>Dr. Jordan Dimitrakoff: Two questions for the CFIDS as well.
Just listening to Corbin's question.
First question, is this the biobank that isn't
registered on clinicaltrials.gov?
>>Kim McCleary: You know, we haven't done that,
but we should because we're not doing
any clinical trials, per se.
But, and also, Beth mentioned the registry
of registries, and we'll make sure to get involved
in that so that people are aware if they don't know
about it already, but from the participant side
of things and also from the academic institutions that
may need a resource like this.
And what we found is that there are there are lot
of scientists out there who would like to do research
on this, but they have no access to a clinical
population, and adding that onto an NIH
application just puts it over the limit of what
they would be able to apply for, funding-wise.
So we see this as a great, shortcut is not word,
but as a great infrastructure support
that we can provide and that gives the patient
community a way to participate
and to galvanize around this kind of research.
>>Dr. Jordan Dimitrakoff: Thank you, and the second question
is if you just give us a little bit more details
about the review process of the applications that
are being submitted.
I mean, you mentioned some of the applications that
you funded, but I think it would be helpful for
the research community and the people in general that
are interested in applying for grants from CFIDS what
the review process involves and what they should expect.
>>Kim McCleary: Absolutely. We have a very
rigorous review process.
We, for the last two funding opportunity
announcements, we had oddly,
both of them generated 37 letters of intent.
Weird that it was the same number both times.
We went through a letter of intent review,
and in this most recent round,
we invited 26 full proposals.
It's an application very similar to the NIH R1
form, just the format.
We sent the -- those applications that
we received out to reviewers within the subject matter.
We involved, I think 54 reviewers internationally
to review those 26 proposals.
And then we do a second level of review for strategic merit.
So they get rescored by the peer reviewers
on scientific merit, and the study design,
the question that it's looking to answer,
how the population is defined, all of those.
And then we look at it from a strategic standpoint.
How likely is this is to advance our knowledge?
Does this fill an important gap?
Is this an idea that if brought forward to the NIH
at the next stage, will be likely to go on
and compete well for funding?
And then the top proposals are funded.
And our pay line is 20 percent,
so we're doing a little bit better than the NIH
overall right now, and we hope with success in our
fundraising that we'll be able to do even
better than that.
But I'm very encouraged that, you know,
there were 37 independent applications for funding
and 26 of those were worth bringing in for full proposal.
So I think, you know, even in the modest amounts that
we fund, we do hope that pipeline begins
to transfer over to what the NIH is seeing.
>>Dr. Jordan Dimitrakoff: So you made Dr. Maier's
definition for successful application promise
of future success.
Thank you.
>>Kim McCleary: [affirmative]
>>Dr. Mary Ann Fletcher: Kim, who made that,
just the group of people that made this strategic
decisions on your application.
That's one question.
>>Kim McCleary: Well, the scientific advisory board
helped us sort of develop what the criteria
for that would be.
And then we looked at -- we looked at some
of the gaps out in the literature,
did a whole literature survey to see what
the gaps were, and that decision was made
and presented to the executive committee makes the final
funding decision.
The executive committee of our board makes the final
funding decisions based on this double step overview.
>>Dr. Mary Ann Fletcher: And then,
the second question is, as an old time feminist,
was there some kind of --
>>Kim McCleary: Old time?
>>Dr. Mary Ann Fletcher: -- feminist.
Was there some kind of gender selection
of the applications that were funded?
[laughter]
>>Kim McCleary: No, you did see a lot of males
up there on the --
>>Dr. Mary Ann Fletcher: I think they were all males, actually.
[laughter]
>>Kim McCleary: In the last round,
that was not the case.
Maybe Dr. Maier and I should have a conversation
about what NIH is doing to diversify the gender gap
in the scientific community.
We did have some young investigators.
We had some minority investigators funded.
So we're trying to better on that,
but the field is small and we have what we have.
[laughs]
>> Male Speaker: It's an opportunity
for female investigators --
>>Kim McCleary: That's right.
>> Male Speaker: -- to apply.
When is your next round?
>>Kim McCleary: We haven't scheduled that yet, but...
>>Dr. Nancy Lee: Eileen.
>>Eileen Holderman: I have a comment,
and then a question for Kim.
The comment is: with so much mischaracterization
about ME/CFS patients and advocates,
so much maligning over the years, and stereotyping,
I just want to say that this panel today has
absolutely proof that these are some of the most
impressive people that I've ever met.
The efforts you're doing and the grace in which
you do it is inspiring.
So I know that you don't get to hear that enough.
I wanted to say that.
[applause]
And my question for Kim is,
I'm not sure it fits in with the biobank,
but many concerns are coming from advocates
and other groups about not looking in the right
places for infectious agents.
And, you know, Dr. Chia [phonetic sp],
HAV6 foundation, and you know,
people and institutes like that want tissue banks
so that viral loads can be looked at in the brain
and heart, and so on.
Does your biobank do something like that?
>>Kim McCleary: Our IRB approval right now
is for blood and buccal tissue.
Those are accessible, easy to get at.
You know, a needle stick.
Tissue samples from organs or brain are a little more
invasive and require --
[laughter]
-- unbelievable protocols that a sample collected
in one place and a sample collected in another place
would, indeed, be comparable from
a pathology standpoint.
And Dr. Dimitrakoff is nodding his head.
There are just some barriers that we don't
have yet the resources, but we have definitely
built sort of the foundation to hopefully
expand to that in the future.
And we've also had many requests for people who'd
like to indicate in a living will that,
should they pass, they would have the opportunity
to provide samples to the biobank.
And we're looking to that as something
for the future as well.
>>Eileen Holderman: Yes, thank you.
That's what I was, you know,
alluding to is when people do pass away,
and now the patient community is getting older.
>>Kim McCleary: Right.
And we've looked at some of the Parkinson's and Alzheimer's
models out there, and just the infrastructure that
the need in order to do the counseling of the family
members, and to keep that sort of updated
on an ongoing basis.
It's a major undertaking, but it's very important
one that we hope, you know,
will someday be part of the biobank.
>>Eileen Holderman: Thank you.
>>Dr. Nancy Lee: Anymore questions?
Oh, we can take one. Ann.
>>Dr. Ann Vincent: So Kim, great work.
So I have a question, and I don't know
if it's classified information.
On the disease modifying agents or disease
modifying strategy that you have,
so what type of pathogenesis
is this directed to?
Is it to infectious, to immune, to autonomic?
>>Kim McCleary: Well, we're not pursuing it
based on any one model.
We're still making use of the very important
strength of investigator initiated ideas about that.
And, you know, if I had the opportunity to talk
a little bit more about each of those projects,
you would see how each of investigators is coming
at this from a different angle.
And then we have sort of the agnostic drug
repurposing screen that's using commercial platform
that this company, Biovista,
has developed to look at mechanism of action based
on the symptomology and the literature,
5,000 of the literature so far,
to see what matches they can find.
And then we'll do a more careful pruning of that
without any real bias starting out from either
an allergy, infection, or, you know, neurologic.
We're just looking at the whole universe of
possibilities, and then trying to narrow down
based on what makes sense in terms of the finding
so far or things that look promising that have come
more recently that may not be fully invested
in the literature, but the knowledge base is building.
>>Steven Krafchick: I guess you're popular, Kim.
How many -- how many samples do you have
and do you have good histories on the patients who have
given the samples?
>>Kim McCleary: We have excellent histories.
We have samples in the bank from about 200
of the 500 people that are consented and registered.
Those break down into dozens of aliquots,
so that's how we're able to make that inventory stretch.
And we use just the sample that the investigator
needs and no more.
Try to conserve that so we have the opportunity
to do this on a very cost effective basis.
>>Steven Krafchick: Thank you.
>>Dr. Nancy Lee: Thank you.
This has been great.
And again, I appreciate all five organizations for
coming here on their own dime and really helping us.
[applause]