Public Comment on Day One - PM (CFSAC Fall 2012)

Uploaded by USGOVHHS on 10.10.2012

first speaker is unless you ear Joseph LANSON.
Maybe you're Joseph listenSON. Great.
Thank you. Five minutes please.
I'm Joseph LANSON. Good afternoon, everyone.
I have been ill for eight years and thank you for hearing me out
today. The various health agencies we
hear a common refrain. We sympathize, we do.
Many of us are living off kinds on of family and friends or
small disability payments so we know about tight budgets.
Be that as it may, I have splendid news.
Ing the beginning of new area start with just .
That's right. Just .
Let me explain how that works. You start with a dime like this
one here. And then you add another brand
new dime. Then you have a brand new
paradigm. That's exactly what me CFS
needs. For years now we have been
caught between infectious agent paradigm which is not panned out
forum teen infectious agents and the psychosomatic paradigm which
fails to explain aspects of illness.
There is a way fore. In the press conference
announcing XMRV study results Ian and collaborators noticed
the abnormalities associated with me CFS.
Look at the demo study Australia, where in the
infectious agent was irrelevant some stayed sick regardless how
they were infectd or what with the ReTUXIMAB studies in Norway.
Nancy clymas. Mary Ann Fletcher and others
here in the U.S., seems some kind of immune disorder.
Absolutely, there are allkine of neurological endocrine and
psychiatric effects of this disease.
However, given the initial course of the illness, in other
words it seems to be post infectious, me CFS must start in
the immune system. I don't see how we can draw any
other conclusion. What kind of immune disorder is
it? My idea is me CFS is a
mitochondrial immune disorder. Researchers have long documentd
mitochondrial dysfunction but never explained why it occurs.
Only in the last few years researchers learn the role
mitochondria have in innate immune signaling.
Mitochondrial antiviral signaling.
It forms an shapes large signature that willing protone
aggregates in a pre-ON lock way so a confirmational type protein
process. In fairness no one has tied it
to any illness yet. Or even seen it mall function.
However, let me share this quotation from a research
article on MAS. A key unanswered question
relates to reverseibility of MAS confirmational change.
A memory of this change wouldn't be day sired property.
One may imagine this leading to controlled antiviral signaling
and associated pathology. What uncontrolled antiviral look
like. Would it produce plea
inflammatory cytokine? AutoAnn bodies for no apparent
reason. I woner if the signaling
interfere with energy production in the mitochondria.
So maybe we don't have a budget for me CFS research.
Maybe medical since should research mitochondrial immunity.
Imagine the number of illnesses we can solve by accident.
Isn't that how medical discovery usually happens, by accident?
Accidently we might more about me CFS than years of research
on purpose with the wrong assumptions learned.
Are we ready to buy a new paradigm?
Now everyone look under your seats, you get , you get ,
you get . I'm lying.
Actually there's nothing under your seats.
I'm not OPRAH. For two free dimes.
I brought enough for everyone. If you done like my paradigm you
can fine your own. Thank you.
The next person is on the phone, Donna Pierson.
Let me make ta call.
Is this Donna Pierson?
Yes, it is.
This is Dr. Lee. You have five minutes to speak.
Hi. Thank you.
My name is Donna Pierson, I'm a patient advocate.
I'm married in my early s and I worked my way up the
corporate ladder to vice president for a real estate
syndication firm. In the years following I
establishd by management company, raised a family and led
a full active life. In a came down with a flu
that was worse than anything I experienced.
I took an act of will to hold my head up and even to speak.
While being driven to the -- I
wonderd if I was going to a coma.
Latest tests proved the diagnosis incorrect.
I did recover enough to return to work but in the months that
followed my health decline ad I push and crashd, went from
doctor and continually misdiagnosed.
I had no choice but to sell the business I worked so hard to
build. Since then, some as pecks of the
condition have improvedd. The treatments that manage ortho
static intolerance, endocrine, autonomic disfunctions or other
issues. However, I live each an every
day with pain, sensory overload, shortness of breath,
neurocognitive symptom, food allergy, chemical sensitivities,
nausea and more. Common variable immune
deficiency as well. As is often the case with this
illness not one of the treatments helpd in the
materials offered by the CDC or CSFAC.
The following questions are asked on behalf of every patient
who would like to know why. One must debilitated individuals
be forced to do their own research despite thousands of
study of millions of patients all over the world.
Why does the CDC continue to ignore the cry from patients
regarding use of the harmful tool kit?
Why are so many recommendations made by this committee
disregardd year after year? Why does this committee allow
that to continue? Why has the request of
organizations and numerous advocates wishing to work
together towards a strategic coordinated fully funded plan
been satisfied by key deputy whose claim no time at all to
meet with them. Why can we work to find acceptd
indicators for preliminary diagnosis such as CPET, KPS
natural killer cell function viral loads while we search to
find biomarkers. As we debate the science
patients are toll there's nothing wrong with them.
. They're depressed and the state
that untilnesss do not exist. Why must patient whose suffer
with a devastating illness suffer due to uninformed public,
disrespectful community and far too many indifferent government
officials. Finally, why is this public
testimony set up in such an unproductive way?
Participants travel from all over the country to attend
meetings at experience financially an medically.
Little value seems to be placed on the testimonies given and
speakers are seemingly ignored afterward.
Being given an opportunity to speak at the members of the
committee is not same as giving an opportunity to speak with
them. According to your charter, you
are responsible to implement programs which inform the public
healthcare and biomedical academic and research
communities. You are also responsible to
partner to improve the quality of life for patients.
Despite your efforts the programs in place have been
profoundly unsuccessful. During the recent hospital stay
not one single doctor nurse technician assistant or other
practitioner knew the first thing about this illness.
If you asked other patients you he will hear difference vary
year ago on the same theme over an over again.
Further, if you would ask patients if they believe a
government agency has taken action over the past decade to
improve the quality of life, you would be met with resounding no.
For these reasons and others, I prevail upon you to find ways to
truly partner with patient advocate and organizations.
A community has commitment determination and persevere.
A goal to ask the due toy say sign charter.
Organizations find a wealth of information and resources for
meetings and workshops, advocates offer an opportunity
for front line insight regarding impact of diagnostic and
treatment methods. The planned appointment of free
non-voting patient liaison is a mall step forward how far, the
ad hoc group convened to address challenges of the disease is
mising a key elm. The stakeholders.
Engaging the patient community is the only way to ensure the
knowledge garnerd through academia science an government
can be combined thank you years of personal experience with
challenging complex and multi-systemic disease.
If you as the this committee, the HHS, CDC and all other
agencies to take every opportunity available to
collaborate with our community toward achieving the best
possible outcome regarding our mutual goals.
I urge you to dead kit yourself to this issue.
Millions o lives are at stake. Thank you.
Thank you very much.
I just wanted to check, can people in the back of the room
hear? Is it working okay?
Thank you. The next speaker is -- here in
this room Debra WOFF.
Now it's JosephINA.
There's no an old song I wanted to play for you but I
coup arrange it, it says house built on a weak foundation will
not stand, oh, no. Stories told until all creation
will not stand, oh no. Research for me CFS has been
built on a pitfully weak foundation.
The CDC has totally neglectd the epidemiology and there by
sabatoge the progress of medical science where me CFS is
concernd. Which leads me sick since
very, very sick but the CDC epidemiologist have made it
clear, they prefer Indiana Jones type adventures and exotic
climbs to us. The senior officer of the two
man epidemiology team CDC sent to incline village Nevada after
the outbreak refused to examine any patients or take any
Local doctor managed to force a few blood samples on the junior
man as he left town but to no aVail.
Back at CDC headquarters in Atlanta the scene was contempt
for meCFS. Contempt fester rootd deep in
the walls, staff hung up signs around the office delivery
satirizing the me CFS patients as ma lingering whineers that
were very whitty. Outside experts told them there
by laying down the false trail of fatigue that has misled
researchers and cheatd patients of care ever since.
Now it's years on, HIV AIDS has been tamed so alas not
vanquished but us with our own acquired immune deficiency
syndrome, in the absense of epidemiology and serious
research, CDC and NIH, whose salaries we pay has preferred to
blame psychological causes and cures following Dr. Reeves and
English friends. Finally the ridiculous telephone
survey in Georgia produced data that allowed Dr. Reeves to
remole the me CFS definition into a distinctly
psychological ailment. One thing has been constant.
The institutionalized misogyny of the government agencies,
conspicuous majority of me CFS patients have been women, a good
reason not to bother about them. This is an emergency now.
million of us at least are in various degrees of dying.
million worldwide what we need now is within a month or
two, to make the disease me CFS reportable and report it.
I can hear the objections already.
CDC has no sure fire definition to go by.
That must not be allowed to stop science, we start with an's
example of doubling up on (inaudible) Canadian
definitions then we make the classic me CFS criteria collapse
after exertion, you can call it may may raise, we add in
depressed and cytotoxicity and other immune characteristics.
No, this isn't perfect but neither are definitions for
many, many other diseases. It is good enough like when --
that is the productive way the get going.
Second urgency, once me CFS is reportable, CDC should get its
hands on every qualified corpse it can find.
One minute.
Autopsy will let us break the code on this disease.
One recently yielded a brilliant insight on mechanisms by which
the Epstein bar virus could destroy brain cells in MS.
That was in England. We also need some doctors.
Now there are perhaps about specialists in the whole
country. Please, CDC, take down the
ridiculous tool kit on Friday, then put together from America's
top clinicians a proper briefing for practicing physicians in the
summary to go into every medical school course this America.
All CDC staff is required to read everything written on all
manipulations an imaginations that went on to hide failures of
CGT to produce desired results in Britain's million case
As hairy bellAFONTE concludes, house built on a rocks
foundation will stand. Now CDC an NIH must at long last
build a strong foundation for science to go forward.
Thank you.
[Applause] Next speaker is
Can I make one comment in We're past the time.
Speak into the -- So we can hear it into the
Anyone who wants to read up on some of the historic facts I
mentioned for the first decade after incline village, read hill
Harrison's untitled book ossler's web which is a
brilliant case of documentation and Hillary would have been a
brilliant muckraker if she had not gotten this disease.
I just wanted to share my own son's experience being treated.
We heard about the FDA about the issue of biomarkers, the need to
be able to track medications, et cetera.
Sometimes the good fortune of going to Dr. CLYMAS who had the
two day exercise testing to show what the impact is on his
system. He's also had extensive cytokine
testing, thanks to Mary Fletcher.
Dr. Fletcher. He's had NK cells, Dr. CLYM,S
recognizes he has high IL- and he's referred him to
rheumatologist, based on the IL- and other cytokine profiles
laid out a treatment regimen for him starting today with
(indiscernible) and if that doesn't work within three months
going to other diseases. He will monitor the effects of
that treatment, using the same cytokines and decide whether --
and my son's other symptoms anteside whether to go on.
So doctors today are using these cytokines.
Dr. Fletcher talked about and making treatment decisions and
monitoring the impact of those treatment decisions.
So as far as my testimony. The CFS patient organization an
advocates submitted a position paper to the CDC an supported
the CFS recommendation to remove the CFS tool kit and make the
primer available. We held a success recommendation
because we have experience to (indiscernible) direct result of
the way the tool kit and CDC CFS website represent me CFS,
talking about the disease described by the Canadian
consensus criteria, not FAKUDA CFS.
The tool kit fails to convey the seriousness but also provides
greatly inadequate diagnostic guidance require PEN as cardinal
symptom. Worse primary treatment
recommendations include CBT and get, justify lastly the tool kit
states the same clinical guidance is appropriate for me
CFS and illness describe chronic fatigue minus the four symptoms.
Does anyone really believe the same clinical guidelines
appropriate for chronic fatigue caused by deconditioning or
coping styles are also appropriate for me CFS.
CDC is defendd the tool kit that it introduces doctors to me CFS
and opens a dialogue with patients.
It does neither. Of all the contempt of the tool
kit is me CFS medical is not medical education but
miseducation that permeated or medical practice, nation
premiere health clinic, insurance company reimbursement
practices and public consciousness, robbing patients
of care an support of doctors and familys when folks need I.
These problems are not unique to the CDC tool kit but they're
also seen on the rest of the CDC CFS website including the new
CME. CDC cannot ignore the consensus
of those who live with the disease or treat it.
It will adopt the recommendations if it serious.
It will adopt the recommendations of the CSFAC and
patient community without delay. If it represents a radical leap
forward in diagnosesis and care of patient and the possibility
of discarding the deeply flawd tool kit.
Implementing these recommendations has impact
beyond quality of medical care. As you know, Dr. Kweder stated
the pharmaceutical company also not invest in a disease if the
disease is not well defined. Issue is rootd in CDC failure to
appropriately define me CFS separate from other causes of
chronic fatigue. Doctors are confused between me
CFS and illness depression an MAL adaptive coping styles.
Any wonder pharmaceutical companies are also confused, it
will not invest. CDC created and perpetuated this
problem. They want the fix not create to
fourth definition but embracing the expertise of the community,
international me CFS expert whose have proven they
understand the disease. This must an can be done quickly
using the definitions like the Canadian consensus criteria and
guidance like the CFS primer that these experts have
developed and are already using in their practice.
We cannot afford more years of study before something is done.
So what is to be an CSFAC recommendations on the tool kit
and primer? In the letter to the alliance of
patient organizations Dr. Koh declined to meet but told us I
quote CSFAC provides mechanism to ensure stakeholders are
engaged and have the opportunities to offer input.
DHHS implement these CSFAC recommendations or will they
ignore them like they have in the past.
One minute.
Thank you. When when DHHS refuses to engage
stakeholders directly, that ignores the input and
recommendations from the mechanisms per stakeholder
input, improve once again you don't take me CFS patients
seriously or these patients seriously.
One comment about patient advocacy.
We heard the immunity needs to advocate if they want change.
This community has been ad sew
Kateing for years an forming alliance to drive fundamental
change in federal policy using every means available to us.
You need to understand two things. These patients are so
sick, I talk to them every day. I'm healthy but they're so sick,
health so fragile they struggle to advocate on a day-to-day
basis. They maybe in the morning but
out in the afternoon. Second thing is because of the
way this disease has been created stigma ma, few healthy
people are involved because they're so busy supporting their
family or because their family doesn't believe they're really
sick. As healthy people you and I need
to act surgeonly and push through the catch we keep
hearing about today. We cannot sit back and wait for
advocates to make the change for themselvess if they're unable
to. Thank you.
Next speaker is Denise LOPEZ MAHANO.
I would like to remind everyone what he looks like
since he can't be here today. I sent the FDA for their current
positive efforts for the me CFS community and declaration that
me CFS is serious life threatening illness.
These efforts while preliminary are already in sharp contrast to
the rest of the approach taken by HHS.
The province of a glacier is
easier to measure than for us to measure what HHS approximate
agencies have done for me CFS. I am here to emphasize that
while HHS and CSFAC fiddle and diddle for years on end, lives
are ruind. Enough fiddling and diddleing.
On June , the me CFS community requested key HHS
deputies meet with patient representatives to formulate a
response to me CFS addressing these priorities.
You may have heard them. Resolveing the definition, name
and classification confusion. Providing a fair share of
research funding. Educating the medical community.
Accelerating approval of treatments for me CFS.
A request was turned down. We were told that the HHS ad hoc
working group is formulateing the plan for us. We reiterated
our request August th, ,. Again, we were robust, both
letters are attachd in my written comment.
In his latest letter Dr. Koh said quote while the ad hoc
working group and its charge are inlearnly internal to HHS, some
of the members are also ex-officio members of the CSFAC.
Where they hear the stakeholder perspective.
CSFAC provides a mechanism to ensure stakeholders are engaged
and have opportunities to offer input.
End quote. He refers to quote, our
continued collaboration end quote.
To date there's no collaboration with the me CFS community.
Recommendations they when to CSFAC and stakeholders are
routinely ignored, claiming CSFAC is a mechanismtor
stakeholder input is meaningless.
Many questions come to mind about the working group.
Among them, which definition is the working group we're using.
Clearly a strategy to unravel illness will be different than
one targetd specifically to me CFS.
What are the stated and implicit goals an objectives and end
points for the plan? What is the time line for
publishing and enacting the strategy.
What level of resource commitment will the strategy
have? A strategy built with a
million-dollar a year commitment is very different
than one built million-dollar per year
commitment. Most importantly why are CSFAC
members stakeholders including clinicians, researchers and
patients working on the plan with you.
Patients had to educate ourselves about me CFS about
symptom treatment, about research and research findings
because very few medical professionals know anything
about CFS or willing to acknowledge physiological
existence. We have herbd positions as
partners to collaborate on a meaningful coordinated plan, a
model scene in Alzheimer's and autism national plans. Given
HHS inaction regarding all things me CFS the lack of
resources to adequately address a disease as severe as me CFS an
impact o lives. The history ignoring me CFS
experts an stakeholders. You must understand are grave
concerns about ad hoc working group and its work.
You must understand key stakeholders must be engaged in
development of a strategic coordinated and fully funded
response to me CFS. Successful strategies are
developed with ongoing two way engagement with key
stakeholders. Stakeholders were an integral
part of the development of the autism Alzheimer's plans.
Remember that. Those plans aVail themselves
substantial detailed community input.
We are the stakeholders here. The ones whose lives are at
stake and HHS must actively and directly engage with us in
developing our much-needed plan. How can HHS resolve the fiddling
and move things forward? What any CFS is lacking is a
coordinated thoughtful plan. By working with us, by working
with the me CFS community to develop a meaningful coordinated
strategic fully funded plan, that delivers measureable
benefits to everyone affectd by me CFS, HHS can actually help
us. And in case you haven't heard,
the tool kit must go. Thank you.
Thank you.
The next person is faith Newton.
Good afternoon, my name is faith Newton, associate
professor of education at Delaware state university.
Today I'm speaking to you less as a parent of a sob with with
pediatric me CFS than as educational researcher and
career administrator and public education.
The reason for this distinction is that as parents and family
members of children with me CFS, we all spend far too much time
of our lives helpless or deferring our hopes for progress
until the next study or the next round of testing.
But education is different. There is now beginning to be a
body of work that tells us what we can do right specifically
what we can do right now to improve experiences an
performances of children with me CFS in our schools.
We're moving from the ole way of thinking that an accommodation
is a school nurse having to place the child having a place
for the child to rest between classes to a new recipe for
instruction, modified schedules can impower our students to
complete classes in the schools. We are moving to an environment
which the concepts of mastery versus completion and sequential
rather than multi-task instruction has started to
become the tools that make honors classes an AP classes
accessible to children with me CFS.
These understandings are neither complete nor universeally
acceptd. We find schools that refuse
basic students, basic services
to students with pediatric me CFS.
Teachers who don't want to prioritize work or don't want to
compromise on testing. We have nurses that don't
believe that me CFS is a disease.
That being said, however, there are tools available now,
information and strategies that all school psychologist,
guidance counselors and teachers should know.
That will have an immediate positive effect and impact on
the academic success of our students with me CFS.
Education is difference for medicine in that sense.
When we have something known to be % good we done have to wait
for every outlieer to be accountd for.
We don't have to have it to be perfect.
I am making three formal proposals, recommendations to
the committee. First I would like to suggest
that CSFAC separate out education from the committee on
education and patient quality of life.
With its members being representatives from public
education, brain research, me CFS treatment, special education
law, higher Ed and relevant disciplines.
I think it's necessary to reconstitute a separate
subcomittee on education because the overwhelming membership of
CSFAC is by nature of charter clinical rather than
educational. But the education issues for
students with pediatric me CFS is critical area in which this
committee can do measureable good very quickly.
Secondly, I would like to suggest that this education
subcomittee be taskd on a regular basis at each meeting
once a year, whatever the committee decides to make a
public report on major findings and trends and educational
issues for pediatric me CFS students.
This will serve to keep an active focus on this issue and
will provide a way for many people who attend these meetings
or watch the live streaming to keep up with what's happening in
our schools and students with me CFS.
Finally, I think the education subcomittee should be charged
over the next year with developing me CFS fact sheet for
educators that delineate the symptoms of illness, the current
as well as current state of best practices and instructional
accommodations an modifications for our students.
I'm currently working with one me CFS fact sheet that will be
Vail to believe all educators an parents.
This is a chance -- One minute.
Not only for the committee to have impact on that process, but
also to ensure public school teachers and staff as well as
our parents would now be aware how we can make a difference in
educating our students with me CFS.
It is only because of what CSFAC has done has worked so well, so
far that we have reached the point where such a proactive
role for the committee can be
suggested. You all should feel justly proud
the attention you have thus for brought to this disease is
causing the he cancational world the take notice.
To make steps towards materially improving the school's lives of
our children. Thank you for considering my
three recommendations. And the opportunity to speak.
Have a nice afternoon.
Thank you.
Ms. MOHANO, are you speaking or are you going to hand here
for Jennifer SITILLA? Okay.
So I should call Jennifer. Is that right?
Okay. Thank you.
Hi, Dr. Lee, this is Jennifer.
Hi, there. Okay.
Thank you. I'm sorry.
So this is Jennifer spitILLA on the phone.
And thank you, very much, you have five minutes.
Thank you. I want to acknowledge my friend
Amy squires who will be assisting me with my testimony
today. I also want to take notice
something you said today, Dr. Lee, when you said that
nothing about me without me. That's what we are asking for.
FDA is moving in this direction and we want HHS and the agencies
to do nothing without me about me.
Take our input, leverage expertise, we are highly
motivated to assist all of you. I want to talk about despair
engenderd by these meetings and work of this committee.
I heard patients say that they don't believe this committee
will help them, there's no point in following your work because
the government doesn't listen to your recommendations.
There are patients who have abandond the hope this committee
will produce meaningful change. Their lives are the same day
after day and they believe that all this committee does is talk.
After each meeting an even today I have observed a frustration,
disappointment and despair among fellow advocates because another
opportunity for progress has been lost.
Everyone at the table today has investd in hours in the work of
this committee. Regarding of good intentions an
engagement in discussions, what matters to patients is
meaningful change. If good intentionings were all
needed we would have cured long ago.
Patients are look for concrete progress and they don't see it
here. What do I mean by concrete
progress? Performance measurement and
metrics are buzz words but it coming down to measuring change.
Dr. Mayier gave us an excellent another example is there's not
enough me CFS research applications coming in to
justify an RFA. What if we could measure
progress on that? First we need to know how many
applications would be enough. That would be the goal.
Then at each meeting NIH reports how many applications have been
received in the previous six months.
We could see whether the applications were increasing or
decreasing over time and we would know exactly how far we
were from reaching the goal. This type of goal setting and
progress measurement could be repeatd across all the domains
of this committee. In my experience knowing where
you stand relative to a goal naturally leads to more targetd
action. We don't measure progress that
way right now. The only goals we have are your
recommendations and the only measurements we see are
responses noted in the recommendations chart which I
have to note have not been updated since last November.
In the absence of metrics from your side of the table, I
thought I would share my own metrics.
I track a variety of things in my day to day life in order to
share concrete numbers with you. This is where Amy will assist
me. days have passd since your
last meeting. I have been disabled for all of
those days. I left the house a total of
times typically for three hours or less.
And five were healthcare visits. I had additional nine email and
phone exchanges with my healthcare team.
I paid to have groceries delivered to my house.
Seven times. I paid to have my house cleand
seven times. My doctors currently prescribe
nine medications for me. I took , pills since your
last meeting. I have had four episodes of
tachycardia and near fainting. days since your last meeting
when I could not get out bed. I down drive a car at all.
I could be take a wack at all. This Saturday is the th
anniversary of the day I got sick.
If I had given birth on October th, ,, that child
would now be an adult. Me CFS ripped into my life ,
days ago. I could have spent those days
building my legal career or writing books or maybe both.
Instead, for , days I have endured every insulted and
change that me CFS has thrown at me.
These are my metrics. And this is my charge to you.
Show me progress. Show me measureable change.
Make a difference so that I can stop counting how many days and
how many ways me CFS is destroying my life.
Thank you.
The next person will be via telephone Andrea BOGELman.
Mr. BOGELman?
This is Nancy Lee at the CSFAC meeting.
Are you ready for pub luck comment?
Yes, I am.
You have five minutes, thank you.
Hello, my name is Andrew BOGELman.
Thank you for allowing me to speak.
In an outbreak of a flu like illness began in lake Tahoe
and nearby areas. A review of patients
published in the annuls of internal medicine stated
neurological symptoms, MRI findings and lymphocyte
phenotyping studies suggest the patients may have been
experiencing a chronic immunologically mediated
inflammatory process of essential nervous system.
A government committee decided to invent a new term to cover
this outbreak. The term they inventd was
chronic fatigue syndrome. More than a decade after the
outbreak, prime time live presented a television news
story about chronic fatigue syndrome.
They conducted a telephone interview with William leaves at
the CDC who told them that the patients in lake Tahoe were
suffering from his steeria. -- hysteria.
In the same knew story Steven Strauss at the NIH said CFS is
so subjective patients will commonly feel better no matter
what you give them. These are not the kind of
beliefs that give one a science of sere -- sense of seriousness
or urgency in solving a problem. And began to woner if the
ongoing research was anything more than just going through the
motions. So let us follow these events.
NIH funding scrapes the bottom of the barrel.
At about the same level as hay fever.
The CDC ignores its own definition of CFS and uses
Oxford criteria studies to justify its views about exercise
as as treatment. Those not familiar with the
Oxford criteria, CFS in the United States no more
appropriate than siting generic coughing studies to make
conclusions about how to treat asthma, TB or pertussis.
That's what the CDC did. They even created a special tool
kit for doctors with treatment suggestions base on this
research. Recently the CSFAC recommendd
the tool kit be removeed from the CDC website.
It is not been removed. But they removed a different
page where they cited full son and white to support exercise as
treatment. Now the conclusion drawn from
the Oxford criteria studies remains but with no way the to
contest it because the citation is gone.
This is not what we hoped for when we heard the website would
be reviewed. This is like painting over
rotting wood and saying it's a repair.
In closing, to thank the CSFAC members for volunteering their
time. Also during my brief talk today
I mentioned a prime time news story, two studies and the
Oxford criteria. The CSFAC members would like to
see any of these, please email me using my contact information.
Thank you for letting me speak.
Thank you, Mr. BOGELman.
[Applause] The next speaker is by phone.
Jill McLaughlin.
Ms. McLaughlin R you ready to present for public comment for
Yes, thank you.
Certainly, you have five minutes.
Thank you, I wanted this is case definition so I'm sure it
will be very boring.
You're going to need to speak a little bit more into the
Okay. I said this is about case
definitions and ICD codes so sure it will be boring so I will
apologize in advance for that. My name is Jill McLaughlin, I
have been involved in advocacy for years and attendd many
conferences and meetings. Once we realize our daughter had
me I became an me advocate. For the last CSFAC meetings
registration required an organizational affiliation.
By the time it was correctd, all the spots for public comments
were filld by me CFS groups. So it hardly gives a fair
unbiased representation T. CSFAC website states that the purpose
is to reside, quote, on issues related to encephalomylitis and
me CFS. It is unclear as to what this
means, a name change? The purpose of a name change has
always been to eliminate the trivializing CFS which this does
not do. There is no recognition or ICD
codes for me CFS. The CSFAC charter an advisory
committee should advise not implement change policy with
terms an meanings. For example fibromyalgia are
pain syndromes with overlaping symptomtology but an FM
committee should not take over RSD, RSD FM or change terms an
diagnoses. CFS shouldn't be combinedd with
called classified or coded to me.
Me has always been classified by the who as distinction
neurological illness since ,.
CFS definition is fatigue plus four minor non-specific
symptoms. This describes or identify as
neurological illness. In fact the CFS definition
excludes neurological illnesses. Also different chapters of the
U.S. ICD which specifically excludes R-. CFS from G-.
ending and vice versa. That exclusion cannot be an
equivalent. So according to -- me CFS are
different. This any equals CFS equals
paradigms seems to be the false believes by the me CFS group.
CDC and NCHS have accurately and separately classified according
to their respective case definitions.
CFS is a syndrome defined by symptoms.
A disease such as me is characterized by symptoms plus
objective measureable findings. Fatigue has been I will defined
and has no objective markers. There is also serious clinical
implications for combining or mislabelling me an CFS.
For example, exercise is recommendd for CFS.
But it is harmful and potentially fatal for me
patients. The use of blendd and combined
terms creates these mixd patient cohorts yielding inconsistent or
even meaningless results. Yet we need a paradigm, CFS CFS,
fatigue research will never help those with serious neurological
and immunological impairments. Every CFS case definition is on
the CSFAC agenda. Any me CFS groups under the
coalition for me CFS -- for me CFS again this year continues to
push NCHS to code CFS to ME where this proposal was rejectd
last year. Coding and classification are
scientific determinations not consensus issue based on
opinions an preferences. For example, infectious agents
have (inaudible) standards with schizophrenia but could add to
lobby to request by schizophrenia as infectious
disease. There's a good deal of misinformation on the
classification of meCFS. CFS is not classified in the
listing by is in the alphabetical index referenced to
me. Who does not say that me and CFS
is synonymous terms. Who gives various possible
relationships between the termss and alphabetical index an term
it is indexd. One is, quote, an undesirable
term, end quote. Given stigma CFS caused, it's
hard the disagree with this. All HHS agencies correctly use
the term CFS except for NIH, ORWH and CSFAC.
Patient groups can call it or make up whatever they want but
federal agencies cannot primarily change substitute or
make Um terms an meanings. They U.S. department of health
and human services policies an principles who are sharing
scientific integrity. HHS requires that all agencies
employees an committees must comply by adhering to official
rules regulation, policy and procedures which must include
firm terminology, recognize diagnoses, criteria
classifications, et cetera. Therefore, the CSFAC should ads
well. Thank you.
Thank you very much.
Our last speaker this afternoon Courtney Miller.
I'm going to be calling her as well.
was dyslexic here. Let me try again.
Let me try again. Okay.
Ms. Miller?
This is Nancy Lee are you ready for your CSFAC public
Yes, I am.
Certainly, you have five minutes.
Thank you for the opportunity to speak today.
My name is Courtney Miller. This summer president Obama
fulfilld a promise he made me a town hall meeting.
He encouraged secretary Sebelius an NIH director Collins to
elevate chronic fatigue syndrome on the list of priorities at
HHS. In his letter the to me
president Obama designates chief of staff Nancy to communicate
with Dr. Collins an assistant secretary Koh about the progress
of the department on me CFS. And this was confirmd with me
that the president's desire to elevate chronic fatigue syndrome
has been communicated to all three of them.
I appreciate Dr. Koh's remarks this morning, acknowledging
that. It is the first time any U.S.
president pub micly elevated me CFS national priority and I want
to take the priority to thank president Obama for my children,
my husband Robert and more than a million Americans with this
dreadful disease. I would like to ask this
committee to write president mob an official thank you letter on
patient and scientific community you represent for his welcome
leadership and intervention. I also want to ask for your help
outlining for secretary Sebelius, director Collins an
Dr. Koh what a strong federal response to me CFS looks like.
The committees recommendations over the years form building
blocks and tacken together they light a path to a strategic plan
for break throughs in science, treatment and understanding of
me CFS. I ask this committee to make a
reccomendation to pursue the basic elements of the strategy
for break through an me CFS. One, the creation of ten year
strategic plans at HHS, NIH, FDA, and revision of CDC plans,
in a process that considers recommendations of the committee
and inputs from patients, expert practitioners an researchers.
Number two, allocation of sub substantial research budget on
order of $ million per year at NIH commensurate with the
burden of illness and on par with the $ million annual
research budgets for multiple sclerosis an Lupus.
Similar lower patient populations than me CFS.
, a dedicated clinical trial program stimulated by federal
support and funding. The test -- to test new an
repurposed medicines an provide data for scientific
investigations why some groups of patients may respond
differently. The power of analyzing why it
works in some patients is pivotal identifying subgroups,
causes an treatments. , federal sponsorship of state
of the science meetings and conferences for visitors an
practicers on a threeier cycle to help demonstrate long term
commitment to attract we searchers in the field.
Number , stakeholder meetings every three years, HHS, NIH, FDA
and CDC. I would add a thank you here for
the FDA recent commitment to a stakeholders meeting there.
Number , establish regional centers for translational
medicine and research under NIH's N cats.
Similar to recommendations this committee has made seven times
in the last years. We have seen what a motivated
federal response to me CFS can look like with the response to
XMRV and NIH pursuit of a multi-center study to evaluate
it. In two short years NIH devoted
$ million and listed would renown virologist Dr. LipKIN
through the rigorous set of patients and controls from six
sites, created a sophisticated biosample collection and
published results, I applaud the NIH for this research.
We need toy assure NIH and extramural scientists that
patients want real science whether it confirms or disproves
research leads. But I also must attest that NIH
cannot stop now. The most important product is
the the highly characterized set of samples to these studies.
Calling them an extraordinary research Dr. LipKIN stated in a
press conference, quote, it's evidence I think of unprecedentd
opportunity for people to do basic and applied research as
which one can prevent or mitigate the strategy that is
CFS. NIH fund researchers to study
the left over samples from what does fail our community.
Immunological disfunction, genetic abnormalities.
Higher incidence or forms of cancer.
And I would ask the committee to make that recommendation as
well. Patients are excited about the
president's engagement in elevating me CFSst CFS in the
critical times. We disclosed a finding that once
offered hope of break through to patient whose had few of them.
At the same time new lines of research are offering powerful
new directions for discovery. Autoimmune findings, B cell
dysfunction. What is essential now is that
everyone live up to the president's direction we know
agencies can do science that fine evidence based treatments
and causes. Hold secretary Sebelius, Dr. Koh
and Collins to the higher standard president Obama is
setting and seek a rapid response from HHS on a scale
comfort with burden of illness or departments investment and
other serious illnesses. We have an opportunity to change
the course of me CFS together. Thank you, Mr. President, thank
you committee members an thank you for everyone who
collaborating on this illness.
That was my wife.
We know.