Choline on the Brain? A Guide to Choline in Chronic Fatigue Syndrome
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FDA Workshop on Drug Development for CFS and ME

Discussion in 'General ME/CFS News' started by Ember, Feb 21, 2013.

  1. Sasha

    Sasha Fine, thank you

    I couldn't remember a word she said til I read what you wrote! :eek:

    She made the point that MS, Alzheimers etc. don't have a known cause like ME doesn't but that doesn't stop heavy-duty drugs approved by the FDA for other conditions being approved for them (without further trials? some sort of fast-track/compassionate grounds thing?).

    At least I think that was her - they're all jumbled up in my head now! It's a mess in my brain...
    justinreilly, Valentijn and Nielk like this.
  2. Ember

    Ember Senior Member

    Will the workshop be available for review?

    Edit -- Sorry, waiting, I missed your post:
  3. Sasha

    Sasha Fine, thank you

    I don't know. You mean on video?

    They keep talking about 'the docket' - not too sure what that it but it sounds like a repository of everybody's documentation. I don't know if that will be public domain.

    I hope Jennie Spotila (who is there and was on one of the panels) might summarise but I don't know if she's planning to. I'd like to see a transcript, especially of the last session.

    Mindy Kitei made a statement - she wasn't on the list.
  4. Ember

    Ember Senior Member

    Has Mindy posted on Twitter? She wrote yesterday, “I'm going to the FDA tomorrow and Friday. If Internet connections and my Kindle cooperate, I'll try to post on Twitter in real or semi-real time. If not, I'll post when I return.”
  5. snowathlete


    from the half hour or so I managed to take a look at today, the FDA panel seemed very engaged and genuine. :thumbsup:
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  6. Sasha

    Sasha Fine, thank you

    I don't really get Twitter but it looks like not:
  7. Ember

    Ember Senior Member

    Thanks, Sasha. I missed the first half.:( I assume that it was also informative:
    I'm so grateful to the doctors especially who showed up uninvited!
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  8. JohnnyD

    JohnnyD Senior Member

    Hi All,

    I managed to copy and paste the Public Testimony portion of the days (days end) from the translators box. These are two minute comments, among them Dr. Dan Peterson, Dr. Judy Mikovitz, Dr. Charles Lapp, Thomas Equels (vice chairman of Hemispherx), and a number of patients. I've corrected some of the transcriptions, but there are plenty of transcribing flubs still. I'll try to post it as a single message, but if it get truncated, I'll attach as a file. It starts with Anita Patton.

    >> Hello, thank you, a lot of cords over there. Thank you for
    having this drug development meeting. I think it is incredibly
    valuable and a pleasure to be here.

    I would say so similar so many things about what so many patients
    have talked about today, except that it naturally falls into
    several different subsets like some people have sudden onset, slow
    onset, some people have low n-k cells, high cytokines, those type
    of things, doctors could get together, just an idea, get together
    subset and really put their research, their science, their
    experience with patients and over like some of the decades to
    identify which people might most likely respond to much treatments
    and my question about the pharmaceutical companies is how can we
    draw them in if there is not a whole lot of representation here
    today, how can we get that and how can we facilitate faster
    treatments to help more people? To that ponent I would bet there
    are a lot watching through webcast, they're certainly probably
    hearing the input and some of them here.

    >> The last thing of course I'm ampligen responder, 15 years,
    long time on it and I'm disappointed that it wasn't approved and
    hoping like is there any way to put some sort of another trial or
    another type of investigation to say that the people who did
    respond ydid they? How can we help hundreds or thousands of
    people who could have a response if there was some sort of global
    trial, another one that would be done.

    >> Okay, thank you for the comments. The point of this is not to
    respond, this is open public session, we're taking comments.

    >> Thank you.

    >> So next on our list, thank you, is Steven chillinski.
    Courtney alexander. I'm sorry. I have a different list here.

    >> Yes, it's been revised three times. Courtney, go ahead.

    >> I'm not courtney, I'm standing in for courtney, Dr. Janet
    Smith, I am on the board of timaron research. Dr. Daniel Peterson
    foundation he foundd and what we're trying to do is scientifically
    redefine CFS ME so we are strictly trying to do the science part,
    but today what I would like to do is plead with the FDA and with
    this panel to go along with the guidelines that just came out with
    the alZEheimers with approving drugs, I would like to plead that
    would go a long with looser rules for approving drugs for CFS ME,
    no approved drugs, thank you. [ Applause ]

    >> Thank you.

    >> Okay. We'll try one more time, Steven chillinski. No?
    Okay. So next we have Judy Mikovits. I know Judy is here.

    >> Dr. Judy, my travel expenses have been covered by several
    physicians and several patients. So I'm just going to read
    because I want to make it quick, I can talk forever. We do not
    know the causes of Multiple Sclerosis, parkinson disease, lupus or
    ME CFS. All of these serious debilitating diseases have
    abnormalities of the immune system and inflammation in common if
    not central components. We made a handout and many of you have it
    today, people who sponsored my travel. Of just a few of those
    biological abnormalities, clinical lab tests, and the drugs with
    potential for repurposing. The FDA has just approved (inaudible)
    immune modulator antioxidant for treatment of Multiple Sclerosis.
    The bright focus in drug discovery foundation just announced a
    phase I clinical trial of (inaudible) an FDA approved cancer drug
    which acts on RET noticed receptor like vitamin D and thyroid
    receptors, both abnormalities on the test. No abnormality tested
    in ME or CFS. In nor way, OVRNGologist just completed small
    clinical trial of FDA approved cancer drug rituxam, with success
    in 30% of patients. The logical next step to do in this trial and
    with the ampligen responders and nonresponders is gene expression
    and profiling and in fact immune profiling to determine the
    difference between responders and nonresponders at the molecular
    level. The FDA has demonstrated commitment by holding this
    unprecedented meeting and we thank you. Drugs which are FDA
    approved are generally safe in humans, of course everything has
    risks. In serious diseases, without treatments, classification
    FDA recently gave ME CFS the benefits far outway the risks. For
    advocacy groups here today and those listening I encourage you to
    fund these clinical trials with the drug companies, fund follow-up
    studies, profiling responders and nonresponders to divide patients
    that exhibit different levels of disease activity, prognostication
    and possibly insight into patho physiology as foundations have
    done. The technology and expertise exists. The absence of
    cognitive agent should not leave this field floundering any
    longer, it's a new era for ME CFS treatment. Thank you. [
    Applause ]

    >> Thank you, Judy. And I think we got the documents but it
    would be good if you would submit those to the public docket so
    that they are officially included in the record as part of your
    presentation. Okay. Thank you. Next we have derek enlander.

    >> Good afternoon. I'm from the Mount Sinai Medical School in
    New York. About a year or so ago we actually received a million
    dollar grant from one of my patients and the dean of the medical
    school said, oh, that is very generous of you, let's actually form
    an ME CFS center. And indeed we formed an ME CFS have at Sinai,
    and our first project was to prove whether TET, was appropriate in
    the disease. We actually have got undergoing the research in
    post-exertional malaise and actually expect to look at 150
    controls and 150 patients in this disease. We're actually going
    to look at the usual array of cytokines and immune markers, but we
    are also going to include genetic studies with a genet cyst Eric
    Shaft, who seems to be actually well known amongst all genetic
    people that I've spoken to. We've got actually a series of 39
    pages of the JE nome study on our first patients. It is most
    remarkable genetic study and we are now actually going to look at
    whether in fact graded exercise therapy is correct method or
    approach and we will actually prove or disprove the pace idea.
    Thank you.

    >> Thank you, Dr. Enlander. If there is additional information
    related to a talk you want to submit to the docket, we would
    welcome you to do that. Thank you. Next Gisela morales, I'm not
    sure if I got that right, I tried to catch people whose name I
    wasn't sure of before.

    >> You are trying very well. Thank you for acknowledging that
    because not everybody takes the time to ask the question. First
    and foremost, thank you for putting this and make Thanksgiving
    happen. Compassionate way today, I'm pleased and happy to be
    here. I am Dr. Morales-Barreit, o, I am here today as caregiver
    (inaudible) love dearly and have been sick for the last six years.
    I'm not going to bother you with the symptoms, they are pretty
    much what has been said all afternoon. He has suffered a lot and
    we were blessed at some point in time to be -- to work and I heard
    it on MPR the voice of Dr. Peterson. So he moved a year ago to
    Incline Village and took him back a couple months ago, but he also
    came back herself again in many, many ways. Being active server
    of the symptoms that she has had has not been easy and watching a
    person that move literally at the speed of light be limited for a
    long time, to bed for days, months and years, really has been
    demoraleizing and emotionally draining. (Inaudible) survivor and
    when I had had cancer I had options for treatment. This
    population has really (inaudible) not really approved by anybody
    and guaranteed they are going to get cured. I'm here after almost
    12 years and I know that if I get sick again God forbid, I can go
    back and find treatments that have been approved. For me, the big
    elephant in the room after everything that has been said is the
    fact that we need pharmaceutical companies, FDA cannot do it
    alone, and we need the pharmaceutical companies to come and play
    the game. The only way I think as psychologist is to also invite
    them with your approval, I think the FDA approval will open up the
    door for the pharmaceuticals to say yes, we can. Yes, we can
    help. So I saw the hand, but I really employ you to look into
    this from that point of view. If you approve any drug with
    whatever the name Ampligen will be nice, but if not, anything that
    will support the patients and open the door for more research and
    more pharmaceutical people coming into this. Thank you very much.
    [ Applause ]

    >> Thank you. And I skipped Mr. Thomas Equels. Close? Okay.

    >> My apologys.

    >> These don't work for up here and that one obviously not very
    good at either.

    >> Little tall for this one, too. First of all, thank everybody,
    FDA staff and most of all the patients and clinicians that have
    taken the time to come here today. I'm the executive vice
    chairman of hemisphere biopharma and we have an experimental drug
    that you have heard about, ampligen, I'd like to share a few words
    about how hemispheric and ampligen got involved with CFS. We were
    30 years ago asked by the FDA to get with I believe Dr. Peterson
    and Dr. Lap with an unusual thing they had out there called the
    Tahoe Flu. And to provide drug on experimental basis for a female
    subject who had remarkable recovery. And I believe there were
    about about 12 additional subjects that were approved that did
    well. That was over 30 years ago and we're here today, and it's
    been a long and difficult journey for small company such as ours,
    but we're participating in this process because we know that there
    are thousands of Americans that are disabled. We know from the
    research that (inaudible) we believe we can contribute to that
    process. And we responded when you asked us 30 years ago to come
    to the table and work and we've toiled in this vineyard for many
    years and we make our commitment that we will be 110 percent with
    you and with you to make this happen. Now we know from the HIV
    Aids epidemic that when there are no drugs the results are dire
    and we believe that we're subsets can be identified where a drug
    can be effective, whether ampligen or other drugs, where there is
    unmet medical need there should be some form of expedited approval
    applied. I'd like to mention --

    >> You have 30 seconds.

    >> Three articles that I think warrant a lot of study, causes of
    death among patients with Chronic Fatigue Syndrome, which deals
    with cardiac increases and shortening of mortality. Cardiac
    toxicity in Chronic Fatigue Syndrome, which deals with effect of
    you heard about 35, 40 different medications, all of which have
    severe, some of which have severe side effects and the impact and
    then a double blind placebo controlled randomized clinical trial
    of tlr-3 agonist, that study has to do with the exercise issues
    and how that may have an effect. Now we've expanded a COMBRAT
    deal of time and money to get to where we are today and I just
    want to say that we're prepared to enter into not a legal
    partnership, but a real partnership with the FDA, with the
    clinician and with the patients to bring relief for people who so
    desperately need it. Thank you.

    [ Applause ]

    >> Thank you. And thank you for paying attention to the hand
    signals. Mr. David Strayer.

    >> Okay. Okay. Dr. Dan Peterson.

    >> Thank you. I am here today representing myself as a caregiver
    but of approximately 9000 patients over the last 30 years which
    has given me -- this disease the frontlines, as they say O. Behalf
    of the patients, their families and even their physicians, I
    implore this esteemed gathering committee to not only device but
    to execute therapeutic strategy which is much needed.

    The Federal diagnostic criteria were established more than 25
    years ago even though revised a few times. The CDC has identified
    counted, surveyd and queried an estimated 1 million people in this
    country suffering from the disorder. The attendance disability
    and poor prognosis documented worldwide by families, physicians
    and the patients. The estimated cost to our country 9 billion
    dollars a year. Diagnostic marker would yield the company 250
    million a year. A therapy probably in the billions of dollars,
    yet 25 years later, we have no FDA approved drug for this
    indication or therapy.

    So the heterogenous nature of had disorder has been a problem and
    I see as an invitation or a beg to study subsets in this disease
    that have the same pathogenic mechanisms. Over this 25 year
    period of therapeutic stagnation, there have been thousands of
    pier reviewed articles published with respect to patho genesis,
    but it's been difficult to connect the dots, I'll just mention a
    few. Worldwide the number one immune logical marker is low MLK
    function and abnormal by everyone who look at them. Speck scans
    abnormal low stress testing is universal finding. Many clinicians
    are already utilizing markers and end points in their own
    practices as they treat patients to document efficacy or to teach
    us more about the disease. Symptomatic therapy unfortunately I
    think is useful in quality of life, but I have not seen it return
    patients to full functional physical nor cognitive conditions. I
    think targeted immune logical therapy has possibility to do that.
    On behalf of clinicians worldwide, you may not know this, we've
    already have established consortiums and collaborations worldwide
    with multi-primary care clinics that are ready and willing to do
    pilot projects, phase roam 1, II and III clinical trials and more
    and I know we're all committed to doing this. So I implore this
    committee to take some action to support the private sector, to
    use the resources and Federal government, science, personnel,
    computing capacity, to develop safe and effective therapies.
    Thank you. [ Applause ]

    >> Thank you. Mary silvey.

    >> Eileen Holderman. James baraniuk. I'm sorry, Eileen? Okay.

    >> Good afternoon, my name is Eileen, an independent advocate for
    ME. Thanks to the FDA for hosting this conference and giving me
    the opportunity to speak. I'd like to address a concern and that
    is the concern of the name of the conference which doesn't
    distinguish between myalgic encephalomyelitis and Chronic Fatigue
    Syndrome. There is one million American men, women and children
    suffering with ME, 17 million worldwide and unfortunately in 1988
    the CDC renamed it Chronic Fatigue Syndrome, which is unscientific
    and dismissive and it was further compounded by definitions that
    included empire cal definition which just states one symptom
    fatigue to have it and today you heard multitudes of symptoms that
    really describe this disease. The results of the faulty
    definition have caused muddied research, the inability to
    replicate findings, no YOUN versal biomarker, drug development
    without target audience, erroneous medical information and
    websites, bad media and press, skewed public perception and most
    importantly neglect and harm inflicted on patients who truly have
    ME. The disease cost the nation billions in lost productivity,
    tax revenue and medical benefits. Funding for this disease has
    been low and it needs to be commiserate with the disease burden.
    The solution is that all the government agencies, the scientific,
    medical, academic, legal advocates and patient communities must
    come together and adopt the Canadian consensus criteria and to
    dismantle use of CFS and move research and treatment forward to
    help the over one million Americans with this disease. Thank you.
    [ Applause ]

    >> Thank you. Dr. Baraniuk.

    >> Thank you very much for letting me speak. I'm Jim from
    Georgetown. I wanted to applaud -- crew for taking on this very
    great challenge, all the best. I also want to tell you that it is
    not all doom and gloom. We started publishing the results of our
    studies from Gulf War illness, patients who also meet Chronic
    Fatigue Syndrome criteria, only about half met Fibromyalgia
    criteria, we've identified three separate dimensions of exercise
    induced FRMI changes that we believe we may be able to apply to
    Chronic Fatigue Syndrome. First off, we've identified white
    matter abnormality that separates the GWICFS people from healthy
    controls. We have two neutrally exclusive, bold blood flow
    responses to exercise that subdivide into four neutral exclusive
    groups and I think begins to address the issue of heterogeneity,
    and these purely objective, you can't use any subjective criteria
    to define them in advance. The simple message is all of these
    subjective criteria that we're using for subjective syndromes
    we're going to get rid of. We're going to have objective
    diseases, we're going to have objective diseases that end up in
    Harrison textbook of medicine. Little bit since I have 30
    seconds, my complex message here is that what we identified is a
    problem in the right interior frontal fACI culus, white matter
    that connects prefrontal lobe here that deals with fatigue and
    valuation of pain. It moves and connects with insula, which deals
    with phantom pain, the emotional link of how much pain means to
    you and it tracks posteriorly to involve the working memory, the
    default network which is your mind wandering or daydreaming that
    all of a sudden breaks up your thoughts, it also connects your
    dorsal and ventral attention networks, which are the systems for
    maintaining your focus. If you think about the cognitive
    dysfunction, the exercise induced exertion exhaustion, that is
    what our model is demonstrating abnormalities in and based on
    this, we're hoping we don't get sequestered and we actually get
    some funds to keep going. Thank you very much.

    >> Thank you.

    [ Applause ]

    >> And again just reminder to you and anyone else, anything you
    want to submit to supplement your public comment, please submit
    them in writing to the docket. Next we go to Mr. Charles Lapp.
    You have all proven me wrong, nobody has sat down, everybody came
    up to the podium.

    >> Thank you for this opportunity, I'm Charles Lapp, a physician
    from Charlotte, North Carolina. I've been treating patients with
    Chronic Fatigue Syndrome since 1985 and I've been using ampligen
    since 1988. My expenses today will be reimbursed by hemispheric,
    but I'm not here to speak for them, I'm here to speak for patients
    and say in the 28 years or 25 years that I've been using ampligen,
    we've had excellent success. I reviewed our records recently, and
    shows over 50% of our patients have responded very nicely to
    ampligen, and about 30% have significant improvements, which is
    sort of disconnect from the data. We chose the end point from the
    ampligen study many years ago and seem to be disconnect from the
    end point we are using to measure the effect compared to the
    patient global impression of change and the physicians global
    impression of change. We see patients who are treated with
    ampligen, who have seen remarkable improvement and return to
    gainful occupation, school and work. I guess the most important
    thick thing that I can say, two points I would make today, one is
    that in all of the years I've been administering ampligen, we have
    not had a serious side effect, not many drugs you can say that
    about. The second thing is that I think history will show that
    when a new drug is brought into a field, for example, when azt,
    was approved for Aids or interferron was approved for
    multimillionaire, many other players and FOORM suit cal houses
    that got in the field and opened up treatment of these two
    illnesses, we hope that perhaps ampligen will do that for Chronic
    Fatigue Syndrome. Thank you for your time.

    >> Thank you, Dr. Lapp.

    >> Steven lempert.

    >> I'm Dr. LECHLert, no financial interest. Approximately 70% of
    patients tested in the 1994 study of Chronic Fatigue Syndrome were
    positive by culture for hhv-6. There is subgroup of cfs patient
    with active hh6 for culture. Characterization by method chain
    reaction as indicated preNOM NANTly hhv-6 A, more frequently than
    hhv-6 b. In the paper by Dr. Blushy titled ampligen inhibits
    herpes, viral repcasion was inhibited by 46 to 98%. The inviTRO,
    antiviral effect reported for ampligen translates clinically to
    being effective inviVO in severely sick CFS patients. Mary was
    (inaudible) positive before ampligen and negative on amplegen
    three times. The drug converts hhv-6 infection into latent HERPes
    virus with marked recovery of both patient health and functioning.
    Patients severely afflicted with neurovigilent human HERPes virus
    6 an occurs M subgroup with Chronic Fatigue Syndrome and
    progressive multiple sclerosis have (inaudible) effective
    antiviral such as ampligen, infusion is part of presumptive viral
    trigger in subgroup of patients with CFS. Antiviral amp, needs to
    be transferred to the FDA antiviral division and reevaluated now
    rather than wait another 10 to 20 years. Thank you. [ Applause ]

    >> Thank you. Mr. Dwight merriman.

    >> Joan, I know she's here. Sorry, grobSTEin.

    >> I'd like to sit down. Thank you. Hello, Dr. Joan, GROB, I'm
    a physician and had ME for 14 years, I think I might have said 13
    earlier, I've lost count. FDA faced with great responsibility to
    encourage rapid development of treatment for this serious disease.
    There are several important issues to keep in mind in this
    process. It's important when evaluating drugs to make sure this
    patient population is well defined. I strongly suggest that the
    FDA require the use of Canadian consensus criteria for all
    studies. In order to better define patient population FDA should
    also make the validation of biomarkers very high priority. You
    have heard today patients have many measurable abnormalities.
    It's important to distinguish between therapeutic agents that
    treat symptoms versus agents that treat underlying cause of ME.
    Although the underlying cause is still unknown it's possible to
    treat symptoms and also possible to treat associated infections
    even if the infection is not the sole cause of the disease. It's
    very likely that multiple agents will have to be used to treat
    this multi system disease. This reality should be addressed in
    the design and evaluation of drug trials. Outcome measures must
    reflect the impact of ME on patients lives, small improvements in
    function are extremely important to patients and we're willing to
    tolerate risk to get improvements. Finally, the FDA should
    demonstrate a sense of great urgency to evaluate therapies for ME.
    As you know, there are currently no approved treatments, patients
    are paying for expensive efKASHS treatments like amp, and rituxin,
    out of pocket, causing financial harm on top of physical
    disability. It is FDA's responsibility to remedy the situation.
    Thank you.

    >> Thank you, Doctor. Jeanett e Burm.

    >> Okay. Nobody has paid for my expenses to be here. I'm here
    to urge the FDA to play a more proactive role in working with
    hemispheric toward approval of ampligen. Subgroup of ME patients
    identified as result of being amp responders and tremendous amount
    can be learn Friday that. One gets impression the aigence senot
    interested in the drug.
    It it is not even a topic at that drug development workshop.
    Dr. Peterson, the physician with the most experience and success
    in administering the drug and many other treatments, as well, has
    not even been invited to one of the panels. I'm happy to see he
    got two minute slot today. At the amp advisory committee, FDA
    conceded no path for amp not accelerated approval process. No
    explanation was given. The FDA recently developed new guidelines
    for accelerated approval process for drugs for patients who are
    not even sick yet. Why the drastic different standard I wonder?
    Looking back at approval of azt, as first drug to TREEFT hiv and
    aids it becomes clear the FDA does have discretion to adopt rule
    if the circumstance is certaintied. At the end of last year the
    FDA approved again under accelerated approval program a drug to
    treat tuberculosis five times more likely (inaudible) standard
    drug treatment for the disease without proof of inproved efficacy.
    I'm not so convinced the FDA hands are bound when it comes to
    approval of ampligen, it seems double standard compared to other
    diseases and other drugs (inaudible) cliff hemispheric is running
    out of money and the drug is going away potentially forever.
    Thank you.

    >> Thank you. And I have three more names that are not on the
    slide, but Mindy katei, I'm sorry, I don't know if I got that even
    close. Okay.

    >> My name is Mindy and I'm a science reporter and blogger at CFS
    central N. 1994, I wrote an investigative piece for Philadelphia
    Magazine called Aids Drug no one can have about the experimental
    drug ampligen, I'm here today to say it is vital that the FDA
    understands one thing, much of the data on this disease is useless
    because CDC and before that the NIH have not been studying
    patients with ME. They are not studying patients with natural
    killer cell defects, vo2 max abnormality or tilt table tests.
    They are not studying patients who neat Canadian consensus
    criteria for the disease or the international consensus criteria.
    [ Applause ]

    While the different definition can get incredibly confusing,
    you'll need to know one thing, the kuda, and revised kuda known as
    empire cal definition as well as oxford definition and the holmes
    definition of this disease are not accurate. Yet CDC, your
    disease definition instead of Canadian consensus and international
    consensus which are accurate, Dr. Leonard Jayson of dePaul
    University has shown in published studies that CDC in employing
    empire cal definition is studying patients with major depressive
    disorder, not patients with ME. That is like doing an hiv trial
    and none of the people are hiv positive. As a result of studying
    the wrong cohort doctors are misinformed. Dr. Lisa corbin said
    she tells her patients that "Monday is for mending, Tuesday is for
    ironing" I found her advice to be in a word clueless. But typical
    of the help any patients receive. Imagine give Thanksgiving Hokie
    advice to patients with hiv or MS, ME patients want and need
    treatment not patronizing proMIEDs. Five of the patients I
    interviewed in 1994 for the article have died, one a good friend
    of mine, three in their 40s and 50s. Do you really think that
    these patients would be alive today if only they had done their
    mending on Monday? Thank you.

    >> Thank you. Next is Mr. Don kalns.

    >> Hi, I'm an owner of small company called hiperion
    biotechnology. I am not really a CFS or ME person. We had
    audacious idea in 2004 that we could measure fatigue by evaluating
    changes in the composition of saliva. The army was very
    interested in this topic because a lot of folks fighting over
    there were profoundly fatigued. Since then we published a number
    of papers about the use of this biomarker, there is several small
    pep tides found in saliva that are quite informative. More
    recently, we have published or given a paper at the American
    association of clinical chemistry describing application of the
    technology to CFS patients. I have to caution that these were
    archival saliva samples, the Providence was not absolutely
    certain, but the poster presentation got an award at this annual
    meeting and pretty well attended meeting.

    I guess why I'm here ultimately is to pose a question. I need
    spit. I need spit from CFS patients, I need spit from control
    patients or not control people. There is a lot of flaws and I'll
    be the first to admit there is serious flaws with the SMOUL cohort
    we looked at in CFS patients. I don't want to step on toes or get
    any ruffled I'm very kog NIZent of the debockel, I would say that
    if well are investigators out there that have protocols that are
    ongoing, please talk to me. I'd want to get that saliva. I would
    require that the saliva sample sent to me are blinded, I don't
    want to have bias, if it doesn't pan out, it doesn't pan out. The
    big market for us is in assessment of fatigue in healthy people,
    not in sick people. But I really think this technology might have
    a lot of applications in terms of evaluating new drugs, in terms
    of efficacy, maybe in predicting crashes, there could be a lot of
    potential here. But come talk to me, I'll be here tomorrow, as
    well. [ Applause ]

    >> Thank you. And Mrs. Dianne lewis. Is she -- you want
    microphone Dianne?

    >> I hope I can do this, lie laptop hasn't been working all day.
    Dianne lewis, licensed certified social worker clinical therapist.
    I'm here to tell you as a professional this disease is not -- does
    not benefit well from CDT. But from a personal note, I want to
    say that the distance between life and death is but one step but
    the difference TWEEB living a daily death is life sentence with
    this chronic disease. The experience robs you of who you are,
    destroys your integrity, personality and stigma and discrimination
    that comes with this disease is uncalled for. For every attempt
    to step forward slow dying nature is no longer a step forward, but
    stepping backward with each passing day. Not having medical
    parity means we are nonexistent in life. I spend most of 75 to
    80% of most days in bed at rest and it was easier for me as single
    parent working two and three jobs to earn what Two master's degree
    than to be sitting on the bedside. So today is a choice and I
    know I will suffer from this and I want to let you know that when
    I work I do four clinical hours of work because I stay within my
    boundaries. I really, that is really taxing me. In order to do
    that, I have to stay completely in bed rest, no contact at all
    possible on Sundays. I will work my four hours Monday, it will
    take me a long time to do my notes. Then when I come home, I am
    in bed Tuesday and Wednesday unless I have appointments and if
    that means I have appointments that extends that week. So I
    actually am living to be able to help people, but I am on
    palliative care plan, medications I get I've been told by our
    hospital administrator, we don't treat that disease here. You
    know, none of the doctors will consider this disease and so every
    single doctor I see or get referred to will only treat just
    symptoms that I would come in and say that was most disturbing. I
    invest a lot of my energy and time and efforts into energy
    conservation, knowing myself, trying to find out ways where I can
    actually achieve something, but know that if I have to use the
    cane, if anybody ever seen a social worker in a hospital we're on
    the fast roll, I have to have the cane slowing me down otherwise
    I'm going to burn out. I can eat a meal and my body will just
    drain of energy.

    >> You have 10 seconds left.

    >> But I do use a lot of hydrotherapy, benefit from soaks, other
    than that my medical interventions, you know, is mockery. I have
    been told to do so many things and the best treatment that I've
    gotten is because I have taken studies from Dr. Peterson and
    Dr. Lapp, and taken them to doctors and doctors will respect that
    research, then they will give me that medication I need otherwise
    I am waiting for the last stages.

    >> Thank you for your comments. [ Applause ]

    >> And for agreeing to be the last speaker unless I think -- we
    covered everybody who didn't get on this list, but had signed up,
    is there any body who thought they were going to speak in the open
    public session and didn't get a chance to? We haven't gone over
    our time, so if there is anybody who didn't get an opportunity and
    has a comment that takes less than two minutes -- one minute,
    okay, that's it.

    >> I would like to thank the FDA for agreeing to this meeting. I
    would like to thank the advocates who helped to put this meeting
    together. What I'd like to kind of reaffirm and reconfirm is that
    FDA was willing in the days of hiv and aids to work with companies
    and bend the rules, change the rules, alter policy, try to figure
    out how to get a medication to people to save their lives. We now
    have I'm referring to as alz, plan which I would ask FDA to allow
    for ampligen. It's changing policy for patients who aren't
    patients yet. It is willing to give people who are not actually
    confirmed with Alzheimer's who knows what potent drugs that are
    coming out to treat these people. But FDA is willing to bend, it
    was mentioned that cituro was fast tracked December 31 of this
    past year, and that this drug kills five times more patients than
    placebo does, but somehow policy was altered because there is
    unmet medical need. There is unmet medical need right here and
    has been for a very long time. And so you know FDA is here and
    ampligen sponsor is here, there is a gap, we got to figure out how
    to bridge the gap. We need the right people in the room and
    figure out how to do that, how do we bridge it. FDA, the
    responsor, the expert clinicians you heard today and there are
    other expert clinicians who have given amp, who could sit down and
    help. Thank you.

    >> Thank you. Okay. I think that closes the open public
    session. You spoke during, we need to be fair here, this is I
    think time now that I turn it over to Dr. (Inaudible) to close the
    meeting and if there are comments that didn't get into open public
    session or if you gave your presentation and neglected to add
    something that you thought about later, please submit your
    comments in writing to the docket. And I really applaud the
    speakers for working with me and doing this without our timer.
    This session facilitated that, we can't always do that in open
    public meetings, but it was the right thing to do here and you
    proved it and worked with me. Thank you very much.

    [ Applause ]

    >> Okay. I just want to close by thanking you again for being
    here today. Thank you for sharing your experiences with what life
    is like living with ME and CFS. You know, terrible cognitive and
    physical impact you have been telling us about, the crashes you
    experience and the fear of crashing and the consequences of you're
    just trying to engage in daily life the way the disease has
    constricted your life and managing physical pain and other
    problems and challenges you have told us about it today. And
    thank you for sharing your experience with what you have been
    trying to do to treat the condition as best you can. And the
    range of therapies that you have described and things you have
    worked well and what has worked better than other things. I also
    want to thank you for being so generous with your time. And after
    spending a few hours with you today having a much better, I know I
    have a better appreciation of what sacrifice you have made and
    really how couragious you are to have come to the meeting today
    knowing full well as I now understand that you are going to have
    consequences for expanding the energy to be here and tell us how
    you are doing, so I think that is just a tremendous courageous
    contribution you are making to on behalf of this disease and other
    patients who couldn't be here, I want to thank you so much. And
    on behalf of this patient focused initiative, I thank you really
    made me feel you set us off to a very challenging start because we
    have to do our best to try to meet the level of contribution that
    you have made to us. This is as I said a first meeting and this
    is I think a first effort for us in this area to be trying to do
    better with trying to capture and describe quality of life and
    life impacts. As I said, we'll have to docket open to receive
    comments until August. We'll be producing a summary report
    capturing the information and having available a transcript and
    raw material so people -- am I doing that? Maybe. And we'll be
    posting that and sharing that with the reviewers and others and so
    this has been a very rich and challenging start for us. Thank you
    again and I hope that I know you'll have a very good day tomorrow
    if you are able to be there. I hope you have a good night.

    [ Applause ]

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  9. JohnnyD

    JohnnyD Senior Member

    Looks like it worked. :)
    Sushi, Nielk and Ember like this.
  10. Nielk


    Ember likes this.
  11. Ember

    Ember Senior Member

    Where did you find this? Are the previous portions also available?
  12. JohnnyD

    JohnnyD Senior Member

    Before they closed down the webinar page, I copied the text out of the translator box that was on the webinar page. I jsut happened to think, -- I wonder if I can copy this text. Sure enough. It would have been available, but I just caught the tail end of the day (I work an the internet connection was timing out at times). I do have a bit of the discussion that happened before the Public Testimony - that I would be happy to post. Here it is, and then you've got all I've got. (Otherwise, you'll have to await the official transcription.)


    it. It makes my liver markers sky rocket, which is ironic, of all
    the other drugs I'm taking, but I tried cymbaltancombination with
    antibiotic I ended up passing out (inaudible) we don't all have
    Fibromyalgia. When you talk about pain and people with the
    condition, it's not necessarily Fibromyalgia.

    >> I might clarify, my question was not meant to imply people
    with Chronic Fatigue Syndrome all have Fibromyalgia. That is not
    what I was getting at, I was grouping the medications together
    since they all have an indication for Fibromyalgia and pain
    specifically related to that.

    >> Sara Eggers: Let's go, we haven't heard --

    >> I just wanted to say since this illness is so long-term, which
    we didn't know in the beginning, but my daughter was 14 when she
    got ill and by 18 doctors had put her on oxycodonePercocet, and
    she had to take a lot of Advil, and wound up with eSOF GEal ulcers
    after a few years of that and would have, she needs to go into
    rehab or something to get off these medications, so I mean, I am
    very angry that she was ever put on them. They wouldn't let me in
    on the decision when I called the doctor and said why, questioned,
    they -- what they were doing, they just told me I had no right
    that she was an adult. I'm her caretaker, she has to live with me
    because she's completely disabled, couldn't even be here, and it's
    just a nightmare. 22 years of pain medication does a lot of bad
    things and I'm getting older, I'm in my 60s now. I don't want to
    take anything that is going to affect my cognition, which is
    already, you know, poor from the brain fog.

    >> Sara Eggers: You are making a good point, I want to make sure
    we are capturing up here is that I think what I'm hearing is that
    since the diagnosis wasn't made, wasn't easily made, that you were
    trying, you and your daughter were trying a number of other things
    and in the end if you knew what you knew now you wouldn't have
    tried that.

    >> If I knew 22 years --

    >> Sara Eggers: Is this a shared experience with everyone? I see
    a lot of head nodding. Yeah.

    >> Like I said, she had hemorrhaging, esopHageal ulcers at 30 and
    her pulse is now, she doesn't just have Chronic Fatigue Syndrome
    or ME, she has ulcers and you know, just it's a nightmare, it's a
    nightmare, I'm sorry.

    >> Sara Eggers: No, if I can take, we'll go with --

    >> I just wanted to add to Mary's point earlier, besides
    Fibromyalgia, different types of pain in CFS. The definition
    includes muscle and joint pain, there haven't been a lot of
    research in to different pain in CFS. For example, some people
    have nerve pain, that is related to like react VAGZ of HERPes
    virus and some people reported they get better when they take
    antiviral for that. There is stomach pain, you know, other types
    of pain.

    >> Sara Eggers: Dianne, right? She had her hand up.

    >> I'm not on any pain medication at this time, although I
    certainly would like to have some. But one thing that I I'm a
    social worker, not a doctor, but I attribute a lot of my pain to
    the fact I'm not getting enough oxygen and therefore my muscles
    are really hurting and so you know, my lack of ability to deep
    breathe, you know, my sleep issues, there's a lot of I think a lot
    of reasons that cause the body to be depleted of oxygen and just
    no way if a doctor doesn't believe that there is anything wrong
    with you. I am on an extreme amount, 400 dollars a month in
    copays for medications and none of it is working. It's all
    palliative care, it doesn't get to the core of the problem. Ant
    virals, pain medication, a lot of medications here, nobody has
    mentioned proVIDual, it keeps me alert and it does really help and
    I also use VyVA nse, instead of aderall. As far as the pain goes,
    I think a lot of pain comes from lack of oxygen and your body is
    just not -- nothing there for it to draw on.

    >> Sara Eggers: Can I, I'm going to ask one question if we have
    time. I caught up on something and I didn't write down who said
    it. I would like to probe a bit deeper into the idea of masking
    symptoms and causing by taking one medication to mask symptoms, I
    think I'm sorry, I don't know which one, the idea that you maybe
    push yourself a little bit more than you should and you would have
    if you weren't on the medication that make you feel good right
    now. Is that an idea --

    >> I thought about that for a while. I think when I'm on it and
    I can't speak in terms of the pharmocology, I just think my body
    is on overdrive, even if I try to even pace myself, very hard to
    pace because you are full of jitters, I find myself feel my body
    running when I'm siting and not turning off. I feel like I'm a
    car and the wheels are turning and I'm not moving and that is if
    I'm lay nothing bed, that is just my side effect. She mentioned
    Providual, I tried it, it made me jump out of my skin. I think
    different people respond to different medications, you have to
    find one that works for you. In terms of what you said, usually
    because of medication, it lasts in my body longer and (inaudible)
    not for me.

    >> One comment, too. It's not actually related to your question.
    My own personal perspective and not to go contrary to the purpose
    of this workshop, we need medicines to help people with CFS and
    but my philosophy is to try to take as few medicines as possible
    and I can do that maybe because I had the illness for 16 years and
    have a good sense, I've tried things and they haven't worked, I
    discontinue them. I think we really as patients I hear people are
    taking a lot of medicine and probably a lot isn't working.

    >> Sara Eggers: I think the doctor has a follow-up to that.

    >> Yeah, you mentioned that you thought one of the adjunctive
    treatments that helped you most was physical therapy and the
    stretching. Can you say a little more about what it was that
    helped? How did it help you specifically?

    >> Yeah, I only did that for a short while and I have to say that
    was really probably the only thing that was good about the
    treatment that I had in the UK. I think it was having a trained
    professional who knew through conversations with me what the
    limits were, basically at that time I could really only do lieing
    and sitting exercises. But was able within that framework to give
    me very limited exercises that I could do every day and I think
    having that guide and none of us are specialists in this and often
    don't know what to do. We want to increase our capacity as much
    as we can and we just don't know the best way to go about it. I
    mean the other thing I would say going back to pacing and I
    disagree with some of what just from my own experience others have
    said, I feel like I can tell when I'm overdoing things, when I'm
    getting to a point where it is going to be too much. My life is
    on a daily basis a very carefully collaborated system, you know.
    I have a mat, I lie on at work. I've arranged all kind of
    complicated work arrangements, I don't work a full day from the
    office. I work from home much of the time. I think we really
    have to figure out kind of by monitoring ourselves carefully what
    works and didn't work. Of course some of us, I have a wonderful
    husband who is there to help is and some people don't have that
    kind of care and help at home. I think if we really can do things
    ourselves that will help.

    >> Sara Eggers: Would anyone, let me see if anyone wants to
    follow-up on that and build on that?

    >> Okay. Thank you.

    >> Yeah, just quickly to build on what Tasha was saying I
    maintain a yoga practice and which is kind of California physical
    therapy, I mean, what is stretching, what daily or every other day
    stretching does, releases endorphins and so there's a natural
    release of natural pain control that comes from developing a
    practice like that and when you first start you can barely do a
    stretch or a posture but that is why I think Tasha's point having
    access to a trained professional, they can help you build and
    develop that so that it can have some effect.

    >> Sara Eggers: Thank you. I will turn and see if my FDA
    colleagues have other questions about particular treatment
    approaches, things you haven't heard of about that you want to
    probe a bit deeper? Dr. Michelle.

    >> One thing that has been mentioned only in passing, but has
    come up in the course of discussion of clinical trials is IV
    saline I'm wondering how many of you have used that and if you
    find it to be beneficial?

    >> IV saline.

    >> Let's go, next Dr. Kiser.

    >> I'll tell you the abbreviated story. I flew down to Puerto
    Rico with my grand solicit son, who didn't have the right paper to
    get on the cruise ship and after many stressful hours we finally
    got him on and I had a total crash. The next morning when I woke
    up I said, I've got to go to the infirmery, I went in, my blood
    pressure went down to like 65 and I fainted. The Belgian doctor
    who understood what Chronic Fatigue Syndrome said I can either
    send you home or give you a bag of saline. He gave me the saline
    drip, I got up and went shopping. [ Applause ]

    >> Sara Eggers: One in the -- one of you in the back. Did you
    want to -- add to that? No? Okay. Come back up. Someone else
    back there?

    >> Yeah, IV saline helps, I consider it a treatment. Relatively
    cheap one. It helps with the light headedness and I also tend to
    get a little bit dehydrated when I have a crash and obviously
    helps with that.

    >> Sara Eggers: Yes?

    >> My name is Joan, I would like to say you can also use oral
    salt and water that can be very effective in an emergency.

    >> Sara Eggers: Any other burning questions? We have five
    minutes left and I just want to do what we did in topic for the
    first topic which is see does anyone else have anything they want
    to share perspective or something to share they haven't heard
    shared by the comments from the panel or by others? Okay.

    >> Joan again. I'd like to just say that in terms of pain
    management, if somebody has a broken leg, it will be very painful
    and it will be less painful as the leg heals. If you break that
    leg repeatedly, it will get more and more difficult to control
    that pain. So we have the equivalent situation here. We don't
    know what the underlying cause of the pain is and so therefore we
    cannot probably adequately treat many people's pain. So I know
    that this is an FDA meeting, but I know there are members of other
    agencies in the government here and I would like to put in a big
    pitch for the fact that we need more research, more money to look
    at the underlying causes of this illness until we find that people
    are going to be taking drugs, having side effects from the drugs,
    watching the drugs effects dissipate over time because we are not
    treating the disease. I'm not saying we should not treat symptoms
    because we should, we need to make everybody comfortable and we
    need clinical trials period of measures, but what we really need
    is research.

    [ Applause ]

    >> Sara Eggers: Here and then --

    >> I have a topical pain medication, so therefore it doesn't
    really affect my cognitive abilities, thank God. But what is in
    it, (inaudible) lido cane, cycle, baclofan, I don't know how that
    is pronounced, anybody is interested in percentages, they can see
    me at the compounded prescription. It works beautifully.

    >> Hello, Anita Patton. Will you please ask question of the
    audience like you ask us to raise our hand, will you ask how many
    people represented here today are from any sort of pharmaceutical
    company that could help us in drug development? Do those --
    would anyone care to volunteer themselves as being from there?

    [ Applause ]

    >> Any other final thoughts? I think we have time for two more

    >> I just want to -- obviously what we really need is approved
    drug treatment and that is why we're all here and I think that's
    the most important thing. I want to give big shoutout to the
    research of Stacy Stevens and Chris Snell, I wear this heart wave
    monitor all the time. I know what my threshold is and I don't
    want to go over, I will crash. I brush my teeth, I sit down so I
    won't go over.
    That is valuable and I think that is something that is maybe
    underutilized at this point.

    >> Sara Eggers: Okay. Okay.

    >> One more and then we'll come with your question. Yes.

    >> One other thing that -- Janet Smith. One other thing that
    hasn't been mentioned that goes along with physical therapy and
    heart rate monitor is I've always asked myself why am I better
    than a lot of patients as far as physically and I think it's
    because the adaptation has come naturally for me. Like the shower
    chair sitting down in the shower, I sit down whenever there is a
    chair available. So I have a handicap sticker, since 1994, and so
    if by using the handicap sticker I can do one more stop at the
    store or see one more patient because I'm using those aids, that
    come naturally for me, but other people they don't think about
    sitting down and how to reserve energy.

    >> Sara Eggers: Thank you. We have one more question from
    Dr. KweedRESHGS.

    >> It's a comment, I want to pick up on something that Joan said,
    which is someone said it and might have been you, Joan, in the
    last session about getting at the underlying cause. And I don't
    want people to think that hearing about the symptoms and the
    varied experiences of patients, even if it is common underlying
    cause and everyone experiences it differently, is not a worthwhile
    endeavor and I do think it is worthwhile in that it helps us
    develop pathway research pathways to explore where we see some of
    the commonality, where we get hints about potentially some of the
    common patho physiology that those particular agents that are
    helpful are addressing. Our goal is to -- that is one reason why
    we want another researcher here and one of our goals is to
    stimulate more conversation, more people smarter than me thinking
    about how could we tie this all together pathophysiologically and
    really begin to target therapy development so yeah, we're helping
    symptoms, which may be first on our plate, but ultimately getting
    to the bottom of this and understanding what that common root is
    so that we can actually cure it. So your point absolutely well
    taken and we are hoping ultimately this kind of exercise will is
    one way to contribute to the building the map.

    >> Sara Eggers: Thank you.

    [ Applause ]

    >> Sara Eggers: I think that is a good place to stop with the
    discussion 2. Again, a fabulous discussion and there are --
    excuse me, I made it this long. There are evaluation forms and if
    you can't find them, I think they're in the back, come find me or
    one of my colleagues and we'll find them. They are completely
    voluntary, if you want to take one in and if you want to take it
    tonight and think about it, we'll be here tomorrow. With that,
    I'm going to turn over to Theresa Toigo who is going to close with
    the open public comment session. I will ask the panel members up
    here, you are free to go down, thank you again, so much. [
    Applause ]

    >> Theresa Toigo: I hope the panel will indulge me and change our
    plan a little bit because it seems like we can maybe do a lot of
    this from people sitting if they don't want to get up. So we'll
    try something a little different here.
    This is the open public comment session and both FDA and believe
    believe in transparent process for information gathering so we
    need to do a little formality here to ensure that we take care of
    the process the requirements. We're going to invite the stake
    holders that are preregisterd and confirmed to share their
    perspective with us during this part of the meeting to to ensure
    the transparency tis important to understand the context of an
    individual's presentation, so you are encouraged to disclose at
    the beginning whether or not any organization paid for your
    expenses to attend this meeting and if you choose -- that is fine,
    as well, that is important part of our open public process that we
    explain that. So how is this session going to work?

    We had originally intended to use a timer, but approximate you are
    willing, if the speakers are willing to work with me, we have two
    minutes for each person to speak and instead of timer, I've got my
    timer and if you are willing, as I'm going to watch it, as you are
    getting close to two minutes I'll let you know, I'll put my hand
    up and then that way we can ensure that we get to everybody that
    everybody is able to get their allotted time and that everybody
    else gets out of here at the time they want. But I think we've
    heard enough today it's not easy for people to stand. So to make
    you come to the center to do it in the timed process is probably
    not ideal. Are you all willing to work with me who will be
    speaking in open public session? When I go like this, know you
    have to get close to wrapping it up. Okay. That is how we'll do

    So I think what is important here is that we know that not all
    patients speak with one voice and we certainly heard that today.
    People are at different stages of a disease and therefore things
    that matter to them are different. But the insight you can
    provide us are going to be helpful to the sessions tomorrow and
    they're also important as we think about the challenging issues
    related to drug development in this particular disease area.

    And so we want like I said to be fair, so you're willing to work
    with me and I'm willing to change the system and hopefully my
    panel here is going to allow me that, so give me some daggers if I
    let the time go to go, let's give it a try. Our first speaker
    it's not on there yet. Okay, the first speaker I have on the list
    is Mrs. Courtney alexander. Mrs. Alexander here? Okay. So Mr.
    Michael walser. Okay. How about Mrs. ANATa patton? Okay.
    Anita, do you want to come up to the microphone? Okay.
    shannah, Tristen and Ember like this.
  13. Ember

    Ember Senior Member

    Thanks! I missed the earlier part. Do we know when the official transcription will be available?
  14. JohnnyD

    JohnnyD Senior Member

    If Hemispherx AdCom is any indication 3+ months.
  15. Ember

    Ember Senior Member

    3+ months...:( Thanks for your Johnny-on-the-spot performance today!:balloons:
  16. WillowJ

    WillowJ คภภเє ɠรค๓թєl

    WA, USA
    I read on twitter that it would be available at the same link in 24-48 hours (presumably after the close of the conference)
    Simon, waiting, Sasha and 2 others like this.
  17. WillowJ

    WillowJ คภภเє ɠรค๓թєl

    WA, USA
    again, the Coalition proposal dealt only with coding: changing from F codes to G codes.

    The definition/description needs to be changed in a different way with a different committee (the coding committee they gave this proposal to doesn't do definition/description) and requires another proposal to someone else, which it's my understanding that the Coalition supports a clearer definition.
  18. WillowJ

    WillowJ คภภเє ɠรค๓թєl

    WA, USA
    One can submit comments to the docket until August 2. jspotila says it is public and will be used to inform their documents. Someone (Kweder?) said the documents would be supplied to decision-makers at the time decisions were being made (which I found very encouraging). Link to the docket is at the end of her post here.
    Sasha likes this.
  19. Ember

    Ember Senior Member

    My question was about coding, not about definition/description. I had thought that the Coalition's proposal involved moving CFS from R to G. This version of ICD-10-CM has generated some concern that “Myalgic to be removed as a diagnosis from the US version of ICD-10-CM, and replaced with CFS.”

    Do you know why the Coalition's website has been disabled?
  20. WillowJ

    WillowJ คภภเє ɠรค๓թєl

    WA, USA
    I didn't know the website had disappeared. I don't think that changing the coding will make ME disappear. Almost no one diagnoses ME in the USA, and if they do they don't use the R code, which is what the Coalition proposes to scrap. (I have seen an argument for using what currently looks like a vague encephalitis code for ME, but I don't have any first-hand information about that - my only first-hand information is that it's not possible to diagnose ME under ICD-09-CM. Either way, it's exceedingly rare. There is little to no ME diagnosed as ME in USA anyway. So it's kind of hard to worry that something which is minimal to absent anyway, would disappear. That train already left. We cannot go back in time and fix that; we have to go on from where we are now.)

    I think it would be dangerous to add a code for ME while leaving a code for CFS, because people would continue to diagnose both people with ME and people with random other diseases with CFS. It's better to (when we can) dismantle the concept of CFS altogether. We don't need it, IMO.

    So there's really not too much we can do at this point, to make the diagnosis worse (other than moving to F40-F69). Hopefully we can make it better. Moving to G code should send a signal that it's a disease to be diagnosed more carefully and paid closer attention to, and have tests and procedures covered by insurance.

    And if we keep at them to stop using especially the worst inclusions like Oxford and the Empirical approach but to assess those patients for other conditions (many of them have various other diagnosable conditions as their primary condition which would explain their illness) and to start with CCC or ICC and better diagnosis and then see who (if anyone) is left, and to subgroup so we can try to figure out if we are dealing with one disease or seven, then we will hopefully get somewhere.

    I think this FDA conference might help, because then we'll finally have an official government document which explains the multiplicity of our symptoms and starts to get at the severity. And rather than just stick it on the record and ignore it, they are actually going to use it to help make decisions. So it's possible we could finally move forward maybe a bit faster than grass growing in winter.

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