Post Your P2P Comments Here

Whether you have sent comments to the P2P and/or CFSAC or you're boycotting the whole process, we need to collect all comments opposing the P2P, so that they can easily be shown to our Congressional representatives as further proof of our opposition.

Simply post (or repost) your comments opposing the P2P in the Comments section below this article!

We are also working on a petition opposing the P2P - I will post a link as soon as it's ready.


Showing 24 reactions

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  • commented 2015-01-26 19:42:41 -0500
    (Posted on behalf of Gina Bettor)

    From: “Burwell, Sylvia M. (HHS/OS)”
    Date: Jan 26, 2015 1:16 AM
    Subject: RE: How “Chronic Fatigue Syndrome” Obscures A Serious Illness
    To: “gina bettor”
    Cc:

    Thank you very much for your e-mail. Our ability to deliver impact depends on your input. I very much appreciate that you’ve taken the time to write, and will be sure to share your message with the most appropriate member of my team for review.

    This Department belongs to the American people, and what you have to say matters to all of us. As we advance our mission of providing Americans with the building blocks of healthy and productive lives, we never lose sight of the fact that ultimately, you are “the boss” – and everything we do is on behalf of everyday Americans who work hard, take responsibility and rely upon the outcomes and services this Department provides.

    To deliver impact and move our mission forward, we are guided by three central tenets: delivering results for the American people on a wide range of important issues; strengthening the relationships that drive progress; and building strong teams with the talent and focus that our challenges call for, and our fellow Americans deserve.

    Working together, we can strengthen the foundation of a stronger middle class, a more prosperous economy, and healthier communities.

    Thank you again for your message.

    Sylvia Burwell

    Secretary
  • commented 2015-01-26 19:41:44 -0500
    (Posted on behalf of Gina Bettor)

    Subject: How “Chronic Fatigue Syndrome” Obscures A Serious Illness
    Date: Mon, 26 Jan 2015 01:16:07 -0500
    From: gina bettor
    Reply-To:
    To: Gina Giarrusso Bettor , Sylvia.Burwell@hhs.gov, Mary Ann Kindel

    http://www.buzzfeed.com/davidtuller/chronic-fatigue-syndrome?utm_term=.wundEPGRD

    Get the BuzzFeed App: http://bzfd.it/bfmobileapps

    Dear Secretary Burwell,

    This is my 4th attempt to try to inform you of the serious harm to the ME patient community, if you continue with the P2P and IOM.
    Other letters were responded to with generic response. Do you ever read your mail?

    Sincerely,

    Gina Bettor
  • commented 2015-01-26 19:40:03 -0500
    (Posted on behalf of Gina Bettor)

    From: gina bettor
    Date: Tue, Jan 20, 2015 at 9:11 PM
    Subject: Severe ME Patients Speak Out – Paradigm Change
    To: Sylvia.Burwell@hhs.gov, Susan.Maier@nih.hhs.gov,
    FrancesCollins@nih.hhs.gov, Llewellyn King / Deborah Waroff
    , Tomfrieden@cdc.gov, “Joyce Grayson (HHS/OASH)”

    http://paradigmchange.me/wp/severe/

    January 20, 2015

    Dear Secretary Burwell, NIH, CDC and HHS,

    I would like to thank Secretary Burwell, for your response to my
    protest of P2P and IOM for ME patients. Your input to the agencies for
    serious biological research dollars, as well providing accurate
    information must be priority one.

    Since 2 million dollars was put into secretive contracts, against the
    experts advice, the severely disabled have written a letter which I am
    resending, in support of their requests.

    Agencies must be accountable for their actions, or lack thereof. I had
    previously written if the P2P goes forward, tremendous harm will be
    done to ME patients, worldwide. In emergency rooms, misinformed
    physicians telling patients to exercise can cause permanent harm.

    Please know, now the UK media is having a field day of press at our
    expense. ME patients improve with excercise…..

    If you really care about the ME patient community, especially, the
    most vulnerable, the severely affected; 1, Educate yourselves by
    watching youtube Dr John Chia with Llewellyn King on MECFS ALERTS,
    episodes 38-41, Dr Chia (an expert that actually cured his son),
    explains the utmost necessity of NOT ATTEMPTING EXERCISE, at all,
    unless you reach a 70% improvement. I honestly feel, I wouldn’t have
    become so ill (going on 22 years) if I had complete bed rest at the
    beginning. 2, Read, really read, the attached letter from the severely
    ill. Not others speaking for what “they support”, like the CAA, that
    didn’t even acknowledge, August 8th as Severe ME Awareness Day.
    3, $$$$ for biological research, or at the very least validate Dr John
    Chia’s work. A sidenote, in the gut, probably is a good place to
    search tissue. In my 18th year of ME, I had to have 2/3 of my colon
    removed, because of an unknown immune hit, causing a colon stricture.
    I am also positive with an enterovirus, cosackie 1,2,3 and 5.

    Lastly, Dr Klimas has me in the CDC study. I am moderate, sometimes
    very severe, with PEM, NK cells are not functioning at 2.1% with many
    other immune inflammatory markers, and cognitive problems are getting
    worse. I need painkillers, help bathing, a housekeeper (which I can
    not afford) and HOPE!

    Sincerely,

    Gina Bettor
    Sudden viral onset 6/16/93 3pm

    PS I have lost my home, marriage and all but 2 well friends.
    Thankfully, my sons are amazing but hurting too. Secretary Burwell, I
    have faith in you. Yesterday, I watched a new utube video of you
    discussing the Affordable Care Act. You seem very sincere, likeable
    and honest. My son can’t have health insurance from my job, since I am
    disabled. Thankfully, he can get his medicines again (severe asthma
    since 2), go to the doctor and be covered. I applaud my President and
    your presentation, so both sides of the aisle, continue healthcare
    availability. He was with preexisting asthma, and uninsured, when he
    required emergency back surgery. He will owe that 80,000 for who knows
    how long.

    So ME affected the economy, with an unworking disabled parent and an
    uninsured 23 year old. Just one story of 17 million. Please give this
    disease the respect, the suffering deserve. Fund, find answers, forget
    psychiatric, exercise, and stigma. You all have the chance to be
    heroes, or continue the untruths the psychiatric lobby is playing out
    in the media because of HHS and the P2P.

    PSS Why the sudden urgency from HHS, 2 unwanted, unstoppable, train
    wreck, secretive contracts, wasting millions? Instead of ever
    following the recommendations from your CFS advisory committee to
    remove the harmful, CDC toolkit (still there) and convene a panel of
    experts, clinicians, stakeholders and patients to define ME, starting
    with the Canadian Consensus Criteria, in October of 2012. Why, for
    shame, for shame. Stop the P2P, IOM and do your jobs of giving us a
    better quality of life, preventing the UK psychiatrists from creating
    headlines of destruction.

    Let the experts do their jobs, government officials don’t make
    definitions…..Byron Hyde, Melvin Ramsey, Carruthers are the original
    experts. Give patients reasons to trust you, or will we continue to be
    mocked, as just done by the P2P emails released by FOIA obtained by
    Jeannette Burmeister for her blog.
  • commented 2015-01-26 19:37:40 -0500
    (Posted on behalf of Gina Bettor)

    From: gina bettor
    Date: Sat, Jan 24, 2015 at 12:30 AM
    Subject: Watch “Episode 71: Deborah Waroff Speaks Out” on YouTube
    To: Sylvia.Burwell@hhs.gov

    Episode 71: Deborah Waroff Speaks Out: http://youtu.be/8SJH0Kcd8uA
  • commented 2015-01-26 19:36:54 -0500
    (Posted on behalf of Gina Bettor)

    From: gina bettor
    Date: Sun, Jan 25, 2015 at 12:40 PM
    Subject: Brains of People with Chronic Fatigue Syndrome Offer Clues
    About Disorder – NYTimes.com
    To: Susan.Maier@nih.hhs.gov, Sylvia.Burwell@hhs.gov

    http://mobile.nytimes.com/blogs/well/2014/11/24/brains-of-people-with-chronic-fatigue-syndrome-offer-clues-about-disorder/?smid=fb-share&referrer=
  • commented 2015-01-17 12:58:34 -0500
    (Posted on behalf of Gina Bettor)

    From: “gina bettor”
    Date: Sep 24, 2014 10:37 PM
    Subject: ME/CFS P2P PROTEST
    To:

    Dear Ms Burwell,

    I am writing to oppose the charade of P2P regarding ME/CFS. Being ill 21 years, this is an insult to my disease and I unequivocally protest. We have the CCC, by the experts that have cared for decades.

    Sincerely,

    Gina Bettor
  • commented 2015-01-17 12:56:55 -0500
    (Posted on behalf of Gina Bettor)

    Dear Secretary Burwell,

    As I continue my protest of the ME P2P. I thought your legal team would be interested in the language of the attached document. Improved quality of life isn’t described in this attached UNUM Provident document.

    Since the patient community overwhelmingly protested the P2P for ME aka ME/CFS. The contract still continues. Considering your vetting committee considered the PACE study using Oxford criteria in contradiction of wishing to retire Oxford, one wonders how that study was chosen as good quality. Endless contradictions.

    Maybe if your legal team looks at the flaws, the changing of improved outcomes, which was unscientific (honest scientists don’t change the paradigms, in the middle of a research study), biased and reprehensible fakes do.

    http://www.midmoors.co.uk/Unum/unum_in_uk.pdf
  • commented 2015-01-17 06:03:23 -0500
    RE: Protest to P2P
    Von Burwell, Sylvia M. (HHS/OS) (HHS/OS) Sylvia.Burwell@hhs.gov
    An Katharina Voss

    Thank you very much for your e-mail. Our ability to deliver impact depends on your input. I very much appreciate that you’ve taken the time to write, and will be sure to share your message with the most appropriate member of my team for review.

    This Department belongs to the American people, and what you have to say matters to all of us. As we advance our mission of providing Americans with the building blocks of healthy and productive lives, we never lose sight of the fact that ultimately, you are “the boss” – and everything we do is on behalf of everyday Americans who work hard, take responsibility and rely upon the outcomes and services this Department provides.

    To deliver impact and move our mission forward, we are guided by three central tenets: delivering results for the American people on a wide range of important issues; strengthening the relationships that drive progress; and building strong teams with the talent and focus that our challenges call for, and our fellow Americans deserve.

    Working together, we can strengthen the foundation of a stronger middle class, a more prosperous economy, and healthier communities.

    Thank you again for your message.

    Sylvia Burwell

    Secretary
  • commented 2015-01-16 19:55:41 -0500
    Let’s not beat around the bush. The NIH is not performing, since it was created to help sick Americans. Simple: it’s time. You will not believe the uproar that this poor behavior is causing among those of us left out to die. And ME is a long-term killer. You Need To Get That !
    WE REQUIRE SOME HELP HERE ! and Please, do it right.
  • commented 2015-01-16 17:54:57 -0500
    (Posted on behalf of Gina Bettor)

    From: Burwell, Sylvia M. (HHS/OS)
    Date: Fri, Jan 16, 2015 at 4:00 PM
    Subject: RE: RE: Protest of P2P
    To: gina bettor

    Thank you very much for your e-mail. Our ability to deliver impact depends on your input. I very much appreciate that you’ve taken the time to write, and will be sure to share your message with the most appropriate member of my team for review.

    This Department belongs to the American people, and what you have to say matters to all of us. As we advance our mission of providing Americans with the building blocks of healthy and productive lives, we never lose sight of the fact that ultimately, you are “the boss” – and
    everything we do is on behalf of everyday Americans who work hard, take responsibility and rely upon the outcomes and services this Department provides.

    To deliver impact and move our mission forward, we are guided by three central tenets: delivering results for the American people on a wide range of important issues; strengthening the relationships that drive progress; and building strong teams with the talent and focus that our challenges call for, and our fellow Americans deserve.

    Working together, we can strengthen the foundation of a stronger middle class, a more prosperous economy, and healthier communities.

    Thank you again for your message.

    Sylvia Burwell

    Secretary
  • commented 2015-01-16 17:50:58 -0500
    (Posted on behalf of Gina Bettor)

    From: gina bettor
    Date: Tue, Jan 13, 2015 at 5:01 AM
    Subject: Re: Protest of P2P
    To: cfsac@hhs.gov, “Joyce Grayson (HHS/OASH)”

    Jan 13, 2015

    Dear Secretary Burwell,

    The purpose was for record and telephone, so I made sure it was in by 4pm. I didn’t know we had until 11:59 or it wouldn’t have been so short. I received an email stating be
    prepared to speak at 1:33 today.

    I just wanted to make sure I was on record as protesting the P2P for ME/CFS. That would be pretty tricky getting an insurance company to pay for a disease that doesn’t exist. ME has a WHO code or had. Fatigue is in many illnesses. I have been debilitated from a full life since 6/16/93. I have ME according to the ME ICC, however they don’t reference their work in the P2P, only PACE was considered of good research value.

    I had such high hopes when you became the secretary of health, Kathleen Sebelius was asked by President Obama to make headway with the ridiculously named chronic fatigue syndrome,
    after speaking with Robert Miller’s wife Courtney. My Congresswoman Debbie Wasserman Schultz from So FL, when I lived in Cooper City had breast cancer and thank God she is able to live life to the fullest. My ability to live life to the fullest stopped when I was a 33 at 3pm on June 16, 1993.

    My story is too long, but oh so common. The suffering, intense. I wouldn’t have believed a flu could come one day and you would never ever get well again, if it didn’t happen to me. Sadly
    it did and to 17 million people worldwide, that look to the US government for leadership. The Japanese have a more effective brain PET scans than we do. Ours is all about blood flow. I doubt you are going to read the article I am referencing, so I will stop here and lastly state for the record it is quite obvious the ME ICC primer didn’t even get discussed. The P2P is junk, if you refer to the PACE trial one time, when you consider a good source of research, it isn’t comprehensible. So Jerrold Spinhirne’s letter needs to be discussed in entirety, not 15 minutes.

    Hoping I was right to have high hopes about you, and you are willing to help us now. If this P2P
    goes forward, we are destined to be discarded and stigmatized for another 30 years, unimaginable, but our past treatment is the best predictor of future treatment by the
    medical profession. If you are lucky enough to even have a knowledgeable and compassionate physician, willing to treat you in the first place. We were lucky enough to have experts that have treated us and defined us.

    Why in the world would you waste 2 million dollars on 2 contracts, when the experts and patients have been against this? Why were the contracts signed without public discussion. Please insert the CFSAC charter here, and read the responsibilities of the DFO. MUST COMMUNICATE BETWEEN COMMITTEE MEMBERS AND THE ASSISTANT SECRETARY OF HEALTH. NOT, REMOVE COMMITTEE MEMBERS FOR VOICING AN OPPOSING OPINION. Please don’t go down in history as another [Stephen] Strauss or Bill Reeves.

    Protect our health and cancel the P2P. Distribute the ME ICC primer far and wide. Any other decision, is proof this process was, is and will continue to be a well orchestrated charade. CFSAC, according to C

    Gina Bettor
  • commented 2015-01-16 17:24:48 -0500
    (Posted on behalf of Gina Bettor)

    Dear Secretary Burwell,

    I am [not] going to request a 3 minute slot (I had no intentions of speaking as many others are more qualified). I am protesting the entire P2P process. I am going to ask the committee to read Gabby Klein and Jerrold Spinhirne’s letters in entirety before making any decisions to support the roll out of the absurd P2P.

    Instead your advice should be to distribute the ME ICC primer far and wide, and refuse any endorsement of the P2P. Your committee had already agreed on the CCC. Finally a 15 minute discussion on something so detrimental to the patient community, is a slap in the face to every single patient.

    I have suffered 21 years, 7 months on the 16th. The only thing I can be sure of is, if you decide to endorse this bullshit, you have sentenced me to ridicule, mistreatment in the emergency room, and continued suffering as well as every other patient in the world. Many countries follow the US. Sadly my government has followed the UK psychiatrists, the powerful lies of insurance companies and never should have used the name chronic fatigue syndrome in the first place.

    Please consider this comment one of protest. In absolutely no way do I consider the P2P, legitimate.

    Gina Bettor
  • commented 2015-01-16 16:17:32 -0500
    (Posted on behalf of Polly Gilreath)

    1/16/15
    (Thanks to Tom Jarret’s compilation upon which this is loosely based)

    Dear Secretary Burwell,

    I have been drowning in the abyss of Myalgic Encephalomyelitis (M.E.) for 15 interminable years. This tormenting illness has kept me in an agony which defies description. M.E.‘s torpid inertia and weakness confine me to a recliner, bed, and wheelchair. NIH’s lack of appropriate funding for effective treatment, along with other inactions and incorrigible actions over the years, has caused this immeasurable suffering and severe debilitation for me and the entire patient population.

    The pinnacle of depravity of our health care government officials is this: I am only one of a million U.S. M.E. sufferers who cannot work full-time or at all, and therefore, do not pay taxes. In contrast, we are huge consumers of tax dollars in the form of disability, Medicare and Medicaid. What part of this makes sense? At a time of budget constraints and cutbacks, this is just ludicrous. Wouldn’t it behoove the U.S. government to get one million people out of their beds and back to work? Not according to NIH which funds M.E. a paltry 5M/year for 1 million patients.

    The fact that our doctors cannot effectively treat us due to NIH’s lack of funding, we traverse among specialists (neurologists, rheumatologists, cardiologists and so on), trying to find an iota of symptomatic relief. In our wake we leave a trail of expensive specialized medical tests whose results, more times than not, are normal. We are huge consumers of health care due to the fact that there is no approved and effective treatment for M.E.! Bizarre as this is, NIH/HHS continues its gross neglect to fund M.E. at a level comparable to other debilitating diseases of this nature.

    Instead, HHS unwisely diverts US taxpayer dollars to pay for two redefinition efforts, the Institute of Medicine (IOM) and Pathways to Prevention (P2P). These illogical and costly initiatives are wasteful because we already have a universally accepted definition among M.E. specialists and patients, the Canadian Consensus Criteria (CCC). It is not within the purview of government to define disease.

    I join a multitude of M.E. advocates, patients, caregivers, researchers and clinicians, and other stakeholders, in total opposition to the IOM and P2P initiatives. Together we are united in stating the following:

    We do not need HHS bureaucrats who are not M.E. experts to redefine this disease.

    We do not need more government-sponsored clinical and/or research definitions for “ME/CFS”

    We do not need more government waste of taxpayer dollars on corrupt initiatives to redefine a disease that has been correctly defined.

    We do not need more government misinformation about “ME/CFS” disseminated to physicians, health insurance carriers, the public, and the press.

    Here is what we do need:

    1) Adopt the CCC now (http://www.mefmaction.com/images/stories/Medical/ME-CFS-Consensus-Document.pdf), with an open mind toward the ICC (http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2796.2011.02428.x/full)

    2) Widely distribute the 2012 ME IC Primer to Doctors (http://www.name-us.org/DefintionsPages/DefinitionsArticles/2012_ICC%20primer.pdf)

    3) Increase funding for biomedical M.E. research to match diseases of similar cost and disability burdens.

    For the public record, my opposition to the IOM and P2P is a complete condemnation of the injurious initiatives to redefine M.E.: P2P and IOM. We refuse to be buried in the subterfuge of CFS. The time has come for the realities of M.E., and the NIH/HHS’s egregious actions toward this illness, to be widely disseminated among congressional leaders, health care workers, and the public at large.

    I write this with great cognitive difficulty and the knowledge that I will suffer PEM (post exertional malaise) in 48 hours. I’ve had 15 long years to know this punishing truth.

    Sincerely,
    Polly A. Gilreath

    To: Sylvia.Burwell@hhs.gov (HHS Secretary)

    cc:
    Barbara.James@hhs.gov (CFSAC ex-officio NIH)
    CFSAC@hhs.gov
    Francis.Collins@nih.hhs.gov (NIH Director)
    Tomfrieden@cdc.gov (CDC Director)
    Susan.Maier@nih.hhs.gov (Chair, Trans-NIH ME/CFS Research Working Group)
    David.Murray2@nih.hhs.gov (Director, Office of Disease Prevention)
    Wanda.Jones@hhs.gov (Deputy Assistant Secretary for Health)
    Elizabeth,Unger@CDC.hhs.gov
  • commented 2015-01-16 15:08:56 -0500
    P2P is not working and it’s squandering what precious little resources we have on an exercise of futility. There are already excellent working definitions of ME, such as the Canadian Consensus Criteria, or the International Consensus Criteria.

    CFS/ME is not just about being “tired.” It is have a body so wearied simply by existing that you have to crawl to the bathroom. It’s about constant, chronic pain all over your body. It’s about isolation from the rest of the world because you are physically unable to join in regular activities.

    End our suffering. End our imprisonment. Spend our resources on something which will actually benefit those of us afflicted with ME/CFS instead of wasting them on P2P.
  • commented 2015-01-16 12:43:38 -0500
    Submitted to P2P and cc’d to
    Francis.Collins@nih.hhs.gov,
    Tomfrieden@cdc.gov,
    Susan.Maier@nih.hhs.gov,
    David.Murray2@nih.hhs.gov,
    Wanda.Jones@hhs.gov,
    Sylvia.Burwell@hhs.gov

    COMMENTS ON: DRAFT EXECUTIVE SUMMARYNATIONAL INSTITUTES OF HEALTH

    Pathways to Prevention Workshop: Advancing the Research on Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome

    I write to you with the background of a sufferer for 25 years and the founder of the Springfield, Ohio, M.E./FM Support Group.

    I concur with many other advocates that using Pathways to Prevention was inappropriate to review this complex and controversial disease.

    My main symptom is post exertional malaise. This symptom is not simply being “tired”. It is the feeling of being hit by a truck after running a marathon at high altitude with a hangover while coming down with the flu. The experience is unlike anything I experienced before sudden onset in August of 1989. I have found only those who have experienced this symptom can grasp the severity.

    The CFS Advisory Committee submitted useful feedback on this report and I ask you to consider those comments to be my recommendations as well. Specifically, I ask that you use the recommendations referring to the inclusion of post exertional malaise as well as retiring the Oxford Definition and adopting the CCC.

    Again, I do not believe the P2P process was appropriate for this endeavor.

    Time and money could have been saved if HHS had adopted the CCC as the experts recommended many months ago.

    Strong insistence that the government fund research into the cause and treatment of this disease should be a priority in an endeavor to help the M.E. community.

    Thank you,

    Colleen Steckel
    Springfield, Ohio, M.E./FM Support Group
  • commented 2015-01-16 01:11:01 -0500
    COMMENTS ON: DRAFT EXECUTIVE SUMMARY
    NATIONAL INSTITUTES OF HEALTH
    Pathways to Prevention Workshop: Advancing the Research on Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome
    December 9–10, 2014
    Susanna Agardy*

    The draft summary reflects contradictory views on the nature of ME/CFS. On the one hand, it recognises the seriousness of ME/CFS (lines 82-86), the importance of post- exertional malaise (PEM) and neurocognitive deficits (106-7) and the overemphasis on fatigue (95-7). The recommendation to retire of the Oxford Criteria (OC) (364-66) and the focus on patient-centred efforts (eg. 166-67, 184, 187-191, 134-46) are welcome. On the other hand, it proposes the inappropriate treatments CBT/GET used in the biopsychosocial prescription (eg, lines 115-16).

    I offer my comments on these contradictions and other issues of concern.

    1.a.) The observation is made that CBT and GET ‘…demonstrate measurable improvements, but this has not translated to improvements in quality of life (QOL).’ (113-16) In view of the admitted failure of these treatments to translate it is difficult to understand why they should be used at all for ME/CFS.

    Harms have been recognised in the Draft Review1. Kindlon2 and Twisk et al3 provide extensive summaries of the risks and harms of CBT/GET. If CBT/GET are found to be ineffective or harmful they will remain so regardless of the name of the treatment strategy of which they form a part- primary treatment or multimodal therapy. Post-exertional malaise (PEM), recognised in this draft report (106-7), prohibits GET 2,3. Perhaps it could be used for rehabilitation when there is recovery from the underlying disease.

    b.) The use of the term ‘QOL’ understates the PACE finding that following 52 weeks of GET treatment patients could cover a shorter distance in the 6 Minute Walking Test (6MWT) than patients with heart failure and those awaiting lung transplant4,5.

    c.) CBT/GET treatments are designed for OC-defined fatigue conditions and ‘assume that the syndrome is perpetuated by reversible physiological changes of deconditioning and avoidance of activity’ with ‘increased perception of effort, leading to further inactivity. Fear of exercise is assumed to be the driver of this supposed condition 4. These descriptors do not apply to ME and it would be illogical and unethical to apply these treatments to ME 3,6,7 . The recommendation perpetuates the legacy of the OC even while its retirement is recommended (364-66).

    d.) The ‘patient-centred QOL outcomes’ (331-32) and the definition of end-points (157-58) which are called for need to include objective measures of treatment outcomes eg, measures of walking ability, actometer-based measures, work ability, etc. Quality of life for patients means the basic ability of being able to be active without the repercussions of PEM. Patients’ priorities should be attended to (277-78). As patients well know, feeling better, which might register on tick-a- box tests, does not mean being able to do more. This is observed by the authors of PACE: `objective measures of physical activity have been found previously to correlate poorly with self-reported out-comes.’8

    It is notable that there appears to be no self-report scale of physical ability tailored specifically to ME. At least the SF-36 physical function scale could be adapted to accommodate PEM by asking how many of the activities a patient can do in one day and without repercussions.

    2. In keeping with the recommendations to keep patients involved in a meaningful and ethical way (184-85, 188) the risks of any treatment in a clinical or experimental setting must be explained to patients. The CBT/GET studies are notably lacking in this regard. For example, in the PACE Protocol patients are told that the treatments are safe and beneficial. Kindlon explains, quoting Cooper et al, “like pharmaceutical therapies, prescribing exercise as therapy, an activity that is gaining in acceptance throughout the medical community, must be predicated on understanding the risks and benefits of exercise as thoroughly as possible.” 2 This risk is a central concern in ME where the distinguishing feature is PEM.

    3. a.) The draft summary recommends that ’the modest benefit from CBT should be studied as an adjunct to other modalities of treatment such as self-management’ (348-50). It is unclear what kind of CBT the authors have in mind. CBT may be beneficial insofar as it is aimed at assisting patients to adjust to their chronic state of illness, combined with supportive approaches. This should be distinguished from the type of CBT practised in the OC-defined studies which aim to remove fear of exercise and to dissuade patients from their beliefs that their illness has a biomedical basis 4. This type of CBT then encourages them to practise GET, exposing them to risk. If patients have learned to fear certain levels of activity for good reason this approach is disrespectful of their learning from experience and responsibility for self as well as invalidating the patient.

    b.)The aim of CBT treatment needs to be considered. The PACE trial results show that the cognitive behaviour therapy group performed even worse than the GET group in the 6MWT and showed no improvement compared with the specialist medical care only group 4,5.

    c.)There may also be difficulties in administering CBT to patients with concentration and memory problems. There appear to be no studies which examine brain-fogged patients’ ability to withstand a session requiring focus and challenges to their thinking. The level of stress this may induce should be considered. The OC do not include cognitive dysfunction symptoms 10 and its customary treatments should not be transposed to ME without careful examination of costs and benefits to the patient.

    4. a.) It is unclear what contribution ‘Studies addressing biopsychosocial parameters (including the mind-body connection)’ (275-76) are expected to make. The biopsychosocial perspective encourages the diagnosis of psychosomatic disease, particularly in the absence of a clear diagnostic test. For ME/CFS it has been refuted by Twisk et al3. Once the tests administered to a patient presenting with ME/CFS symptoms show that ‘all tests are normal’ the default diagnosis of psychosomatic illness is frequently provided. Or, as Hyde points out, patients may first be given the CFS diagnosis: since CFS is diagnosed after the exclusion of other medical conditions the psychosomatic diagnosis remains, by default11. Either way, the patient is stigmatised and condemned to a future of having their missed diagnoses and misdiagnoses perpetuated11.

    b.) Some tragic experiences in the history of ME/CFS have resulted from the biopsychosocial approach. The video ‘Voices from the Shadows’ tells the stories of several severely affected patients whose lives have been greatly worsened by the psychiatric approach and the disbelief accorded to those with ME or CFS12.

    c.) Thus far, as applied to ME/CFS, this model has consisted mainly of the attribution of motives to patients, evidence-free (see 1.c.). On the basis of these attributions patients have been subjected to the crude form of behaviouristic intervention where CBT/GET have become the stimulus to which they are supposed to produce the response of becoming economically productive units (we wish). The underlying medical conditions have been ignored. This approach has not been effective and has deprived patients of dignity and validation.
    d.)The relevance of the biopsychosocial perspective should be seen in the context of the statement by Thomas Insel, director of the NIMH, who said about the effectiveness of psychiatry: “’Whatever we’ve been doing for decades, it ain’t working. And when I look at the numbers- the number of suicides, number of disabilities, mortality data – it’s abysmal, and it’s not getting any better. All of the ways in which we’ve approached these illnesses, and with a lot people working very hard, the outcomes we’ve got to point to are pretty bleak- especially’, he added, ‘compared with the “extraordinary” progress in other fields such as the 70% drop in mortality from cardiovascular disease’ since he went to medical school ‘or the steep reduction in deaths from auto accident and homicides…’ ” and we don’t know which treatments are working for which people.” 13 ( pp 350-51) dimensions of observable behavior and neurobiological measures’ as well as other biomedical techniques in the search in http://www.nimh.nih.gov/research-priorities/rdoc/nimh-research-domain-criteria-rdoc.shtml
    e.) The biopsychosocial perspective has already had immense influence on the research on ME/CFS, using up funds without tangible benefits. In view of the urgency for research in the biomedical sphere this perspective should not be given priority. The vote of no confidence in conventional psychiatric diagnosis by the NIMH should further deter any intentions to take a biopsychosocial route in the search for insight into ME/CFS.
    5. The draft summary states that ‘…this is not a psychological disease in etiology.’ (92-93) The proponents of the OC also agree with this. The controversy lies in the beliefs about the causes of the perpetuation of the disease. The OC proponents claim that patient themselves perpetuate the condition causing their deconditioning (See 1.c.). These assumptions persist even in the face of their own studies’ failure to confirm the assumed underlying features, especially deconditioning. It is unsettling to note the ambiguity left hanging in the above statement (92-93). This incomplete statement allows an interpretation which leaves in doubt the acceptance of serious physical disturbances in ME/CFS noted elsewhere (82-86).

    6. The draft report rightly points out the need for the training of physicians and other therapists. Not only do they lack the knowledge for instructing patients in self-management and GET (131-38), anecdotal evidence also suggests that the instructions they issue are often inappropriate and damaging. They frequently push uninformed, desperate patients keen to do anything to get better, far beyond their limits through unhelpful goal-setting strategies, insisting on increased activity, thereby making them worse.

    The key issue is PEM: professionals need to believe and understand the symptoms peculiar to PEM, the concept of which is frequently foreign to them. They also need to learn that it is best to work with the patients, respecting their limits and feedback and teaching them to listen to their bodies (as in pacing). The draft summary’s emphasis on patient-centred therapy is important for this scenario. For ME it is GET per se which is inherently dangerous and attention should not be shifted to patient attitudes as the cause of problems (135-37).

    Self-management (130-31) is necessary. However, in spite of embellishment with euphemisms like ‘empowerment’ the prescription for it still sends the message, ‘we can do nothing for you’. In practice, patients are left to cope as best they can, with perhaps a few guidelines which may or may not be appropriate.

    7. The draft summary refers to the desirability of a ‘multidisciplinary care team’ (303-05). A patient’s wish list would ask for multidisciplinary teams composed of ME specialist and well-informed specialists in say, neurology, cardiology, immunology, gastroenterology, etc, as required. Well-qualified and sympathetic specialists, as well as acceptance of ME by the welfare systems of each country may leave less work for other types of multidisciplinary care teams. These teams must also keep the medical condition firmly in focus and avoid unproductive excursions into the psychosocial sphere.

    8.a.) As pointed out in the summary, the focus on fatigue (95-97) should be replaced by greater emphasis on PEM and neurocognitive deficits. PEM is the distinctive marker of ME, it is delayed, it can occur in response to very minor exertion, depending on the severity of the disease of the patient. Importantly, PEM is not a unitary symptom but includes the resurgence of numerous symptoms which do not follow exercise in a healthy person, eg, sore throat, headache, tingling, increased brain fog, increased sensitivities to sound, light, foods. The symptoms may be changeable and last for an inordinate time.

    b.) Broad research question: how does exercise trigger such a variety of symptoms? Snell et al14 and others have begun to uncover underlying issues and these finding need to be further pursued.

    c.) The dominant and vague term ‘fatigue’ is confusing and does not describe the symptoms. As the draft summary recommends, patients’ language should be attended to (eg, 184-91). Patient speak of ‘massive crash’ ‘feeling terrible’, ‘flu-like symptoms’,’ brain fog’,’ having no energy’, ‘needing to rest’, ‘dizziness’, etc, rather than fatigue. Orthostatic intolerance also produces the desire to lie down and can be interpreted as fatigue. Sometimes patients have difficulty describing their symptoms and they may settle for ‘fatigue’. As with PEM, the more specific symptoms should guide the research.

    d.) According to Hyde, a diagnosis of fatigue, as in ‘CFS is a mistake because it treats fatigue as if it was a disease in itself, which it is not. It indicates only that something is wrong. Patients with fatigue should have a thorough examination beyond basic tests. “…the various definitions of CFS actively impede physicians’ ability to make a rapid diagnosis and a scientific confirmation of the illness, thus preventing a possible immediate treatment of some of these significantly disabled M.E. patients.” 11
    9. Some parts of the draft summary may create the impression that less is known about ME/CFS than is the case (2-5). Unfortunately, much of the existing biomedical research was not acknowledged in the Review Draft Report to AHRQ 1 because these projects did not achieve more than they did while facing obstacles in funding and support. Due to the acceptance criteria for the AHRQ report the OC-based studies emerge as dominant, distorting the evidence-base. The biomedical research needs to be given credit for discovering numerous abnormalities and possible markers and laying the groundwork for sub-group research, as pointed out by Dr Klimas at the Workshop.

    10. According to the draft summary, ‘The symptoms patients consider clinically meaningful are not in the scientific literature; this discordance must be rectified.’ (166-67) The most important symptoms and those reported by patients are already listed in the Canadian Consensus Criteria and its revisions. 6,7. These criteria are based on specialist doctors’ encounters with some 50,000 patients. They do indeed, reflect patient experience as is recommended at lines184-85. These criteria are the only ones which acknowledge these symptoms. Their use in research and diagnosis would go a long way to rectifying the problem identified at 166-67.

    11. Once the focus is concentrated on patients’ particular symptoms and the limited usefulness of ‘fatigue’ as a definition of ME/CFS is recognised, the frivolous and misleading name Chronic Fatigue Syndrome can also be retired and the way can be cleared for a more precise definition along the lines of the CCC and ICC 6,7.

    *My comments are based on following the research and events in ME/CFS, my own long-standing experience of ME and communication with other patients. I have a background in social research.

    References

    1. AHRQ Diagnosis and Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
    Draft Review Report 2014

    2. Kindlon T, Reporting of Harms Associated with Graded Exercise Therapy and Cognitive
    Behavioural Therapy in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
    Bulletin of the IACFS/ME. 2011;19(2): 59-111
    3.Twisk FN, Maes M, A review on cognitive behavorial therapy (CBT) and graded exercise therapy (GET) in myalgic encephalomyelitis (ME) / chronic fatigue syndrome (CFS): CBT/GET is not only ineffective and not evidence-based, but also potentially harmful for many patients with ME/CFS. Neuro Endocrinol Lett. 2009;30(3):284-99.
    4. White PD, Goldsmith KA, Johnson AL, Potts L, Walwyn R, DeCesare JC, Baber HL, Burgess M, Clark LV, Cox DL, Bavinton J, Angus BJ, Murphy G, Murphy M, O’Dowd H, Wilks D, McCrone P, Chalder T, Sharpe M; PACE trial management group (2011). Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. Lancet 377, 823-36.

    5. Agardy S (2013). Comments on `Recovery from chronic fatigue syndrome after treatments given in the PACE trial’ |letter]Psychological Medicine / Volume 43 / Issue 08 / August 2013, pp 1787-1787, Published online: 19 July 2013

    6. Carruthers BM, van de Sande M. Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: A Clinical Case Definition and Guidelines for Medical Practitioners. An Overview of the Canadian Consensus Document. Bruce M Carruthers, Marjorie van de Sande. 2005.

    7. Carruthers BM, van de Sande MI, De Meirleir KL, et al. Myalgic encephalomyelitis: International Consensus Criteria. J Intern Med. 2011;270(4): 327-38. PMID: 21777306.

    8. White PD, Goldsmith K, Johnson AL, Chalder T, Sharpe M; PACE Trial Management Group (2013). Recovery from chronic fatigue syndrome after treatments given in the PACE trial. Psychological Medicine Jan 31: 1-9 available on CJO2013. doi:10.1017/S0033291713000020

    9. White PD, Sharpe MC, Chalder T, DeCesare JC, Walwyn R and the PACE trial group (2006) Protocol for the PACE trial: A randomised controlled trial of adaptive pacing, cognitive behaviour therapy, and graded exercise as supplements to standardised specialist medical care versus standardised specialist medical care alone for patients with the chronic fatigue syndrome/myalgic encephalomyelitis or encephalopathy, PACE trial protocol: Final version 5.0, 01.02.2006 ISRCTN54285094

    10. Sharpe MC, Archard LC, Banatvala JE et al . A report-chronic fatigue syndrome: guidelines for research. J R Soc Med. 1991;84(2): 118-21PMID: 1999813.

    11. Hyde B, Missed Diagnoses, Myalgic Encephalomyelitis and Chronic Fatigue Syndrome Expanded Edition 2011

    12. Boulton B, Biggs J Voices from the Shadows http://www.meassociation.org.uk/2012/03/voices-from-the-shadows-%E2%80%93-watch-the-film-on-your-computer-from-anywhere-in-the-world/

    13. Greenberg G, The Book of Woe, Scribe, Australia 2013

    14. Snell CR, Stevens SR, Davenport TE, Van Ness JM (213) Discriminative Validity of Metabolic and Workload Measurements to Identify Individuals With Chronic Fatigue Syndrome. Physical Therapy 27 June 2013 10.2522/ ptj.20110368 Physical Therapy
  • commented 2015-01-15 14:44:22 -0500
    After more than 3 decades living with ME/CFS, I am appalled at this abysmal attempt by the NIH in regards to P2P. We’re talking about human lives here, not lab rats! We were treated so much better in the mid 80’s than we are now! To not listen to anyone and go ahead with this is foolish and probably illegal! This is going to explode in your face, so you would be better served to cut your losses and start all over again, this time listening to the people who know what they’re talking about! Sincerely, James Hall Myrtle Beach, SC
  • commented 2015-01-15 09:36:57 -0500
    January 6, 2015

    Dear Secretary Burwell,

    I am a patient suffering from Myalgic Encphalomyelitis and I would like to challenge the validity of the NIH’s Pathway to Prevention (P2P); Advancing the research for Myalgic Encphalomyelitis/Chronic Fatigue Syndrome (ME/CFS).

    I am writing to you as a citizen of the United States who believes that the actions of HHS have and are hindering proper and equal care as promised by HHS’ charge of protecting the health of Americans and providing essential human services, especially for those who are least able to help themselves.

    At the Lake Tahoe outbreak of Myalgic Encephalomyelitis (ME) in the 80’s, CDC made a decision to highjack this serious neuroimmune disease and to derogate it by renaming it with the vague, undignified name “Chronic Fatigue Syndrome” (CFS). Since then, the NIH and the CDC have continuously and stubbornly made certain that this disease remains buried as a vague “fatiguing syndrome”. By their action, they have ensured that progress will be impeded and that the future of this disease remains under strict Government control. This is in contrast from other diseases, where it is the medical expert community that creates criteria. NIH has historically denied proper funding for good scientific research that is based on the biology of the disease. The majority of the meager funding allotted is mostly for studies with a psychological slant to the disease. The CDC has created a vague criteria stressing “fatigue” as the main and only mandatory symptom, in their 1994 Fukuda Criteria. Since then, they have stubbornly held on to it regardless of the production of newer, more accurately descriptive criteria by the medical ME/CFS experts such as the Canadian Consensus Criteria of 2003 (CCC) and the International Consensus Criteria of 2011 (ICC).

    Today, nearly 1 million American men, women, and children, and over 17 million worldwide, suffer from the neuroimmune disease, ME/CFS. The cost to the American economy has been estimated to be in the billions, yet NIH has been spending a mere 5 million dollars a year for researching the disease. This amount does not come close to the amount of funding granted to other equally serious diseases.

    The Canadian Consensus Criteria (CCC) of 2003, created by international medical professionals with experience treating and researching the disease, was very well accepted by the international medical community. For the past ten years, much pressure was put on the CDC by ME/CFS stakeholders, specialists, advocates and patients to adopt the new CCC and to reflect the change on their website. To date, the criteria that appears on the CDC’s website and toolkit remains the 1994 Fukuda criteria.

    In October 2012, the Chronic Fatigue Syndrome Advisory Committee (CFSAC), made a recommendation to the Secretary of the Department of Health and Human Services (HHS); CFSAC recommends that you will promptly convene (by 12/31/12 or as soon as possible thereafter) at least one stakeholders’ (Myalgic Encephalomyelitis (ME)/Chronic Fatigue Syndrome (CFS)experts, patients, advocates) workshop in consultation with CFSAC members to reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS beginning with the 2003 Canadian Consensus Definition for discussion purposes. The Secretary did not heed the advice of HHS’ own appointed federal advisory committee members. Instead, HHS chose to spend close to 2 million dollars for two separate ventures: The HHS/IOM contract for clinical criteria and the NIH’s P2P for research purposes. These two processes were to employ “unbiased”= non-expert panel members in order to guarantee the perpetuation of Government control of the process.

    It is interesting to note that the majority of the ME/CFS community; clinicians, researchers, advocates and patients were in agreement with CFSAC’s recommendation of adopting the Canadian Consensus Criteria (CCC) now, and working on improving it. This is evidenced by the letter to the Secretary of HHS that 50 ME/CFS expert clinicians and researchers signed, informing her that they have in consensus, adopted the CCC and were urging HHS to do so as well. This letter was later endorsed by over 170 patient advocates.

    Nearly 10,000 signatures on two petitions have called for stopping these processes and adopting the CCC now. Advocates have demonstrated in San Francisco and in Washington, DC to protest the HHS contract with IOM and the process of the P2P which have attracted the media and resulting in press coverage. A vigorous twitter campaign has been ongoing highlighting the protest of the IOM and P2P.

    Advocates contacted the media and press and participated in numerous radio, TV, and online interviews and articles about the IOM and P2P issues. Numerous articles and blogs have been written outlining the problems with the two processes and why the majority of stakeholders are protesting both actions. The above mentioned initiatives by advocates, patients, and ME/CFS experts have been and continue to be important to protect the best interests of a million Americans, and 17 million worldwide, who suffer from ME/CFS and to move research and treatment forward.

    Yet, HHS refused to heed the entire ME/CFS community’s voice and forged ahead with the IOM and P2P processes.

    ME expert Dr. Byron Hyde wisely observed in a paper presented in New South Wales in 1998:

    Definitions are not diseases, they are often simply the best descriptions that physicians and researchers can offer, with their always imperfect knowledge, to describe a disease. Good definitions are good because they correspond closely to the disease state being described. It is thus important that those that attempt to define any disease or illness to have long term clinical experience with patients with this illness. There is simply no place for the bureaucrat in defining illness. All definition of epidemic or infectious illness must be based upon persistent clinical examination of the afflicted patient, an understanding and exploration of the environmental factors producing that illness, and pathophysiological examination of tissue from those patients. For similar reasons, I believe that the inclusion of psychiatrists in the defining of an epidemic and obviously disease of infectious origin, simply muddies the water for any serious understanding of that disease. [Hyde, 1998. Emphasis added]

    Historically, diagnostic criteria for diseases are created by the expert medical community, not the Government.

    Dr. Derek Enlander, an expert ME/CFS clinician in NYC, stated in his letter presented at the IOM meeting:

    At present, the Canadian Consensus Criteria are used by a majority of experts who diagnose and treat this disease; they adhere to the concepts defined by Dr. Melvin Ramsay, who helped pioneer research in this disease, in contemporary clinical settings. Were discussion and debate even necessary, one million dollars could still have been saved—a not insignificant percentage of NIH research funding dollars in this area. Given the paucity of funds allowed for research and study of what we know as Chronic Fatigue Syndrome, it seems, with all due respect, to be a shameful waste of money.

    It leaves me with the conclusion that HHS’ move has been a political one at the expense of the wellbeing of the patient. HHS actions show that they have something to gain in keeping this disease in the shadows. They prefer to hold on to an outdated set of criteria which ignores the most important hallmark symptom of the disease; PEM/PENE, post exertional exhaustion. PEM/PENE is the mandatory symptom of the CCC and ICC, thereby distinguishing ME patients from other “fatiguing” illnesses.

    NIH decided on using the P2P process for ME/CFS research purposes. The P2P process, as per its website is not to be used for “controversial topics”. Since its inception, ME/CFS has been complex and controversial, yet NIH ignored that fact. By using the P2P process for ME/CFS and setting the parameters which they have, the results were doomed for failure. In addition, NIH decided to lump every single criteria ever created for ME/CFS (8) no matter how wrong into the mix, as if they all have the same value. This lumping together has ensured that the results will be meaningless.

    To make matters even worse, the p2P was charged with using an “evidence based search” for their report. Dr. Enlander stated: it seems inevitable that any preference given to the “Evidence Base,” may produce a set of loose criteria. In this area, where the ‘evidence’ has long been grossly distorted, and to date has produced a flawed, inaccurate model of this very serious physical disease, such criteria may well describe other conditions or disease models that are, simply put, not the disease described by Ramsay.

    In addition, the choice of a “jury model” unbiased-inexperienced panel writing the final report has ensured that the result will be at best of very low quality. It is impossible for a panel of non-experts to read an evidence based report, listen in to a 1 ½ day workshop and produce a comprehensive report in 24 hours. This “circus act “is not acceptable to me and to the majority of ME/CFS stakeholders, advocates and patients. My future and the future of 17 million patients worldwide will depend on the nefarious actions of the NIH.

    I join multitudes of advocates, patients, caregivers, ME/CFS researchers and clinicians, and other stakeholders, in stating the following:

    We do not need HHS bureaucrats who are not ME/CFS experts to redefine this disease.

    We do not need more Government-sponsored clinical and/or research definitions for ME/CFS

    We do not need more Government waste of taxpayer dollars on corrupt initiatives to redefine a disease that has been correctly defined.

    We do not need more Government misinformation about ME/CFS disseminated to physicians, health insurance carriers, the public, and the press.

    My opposition to IOM and P2P is a complete rejection of these initiatives to redefine ME/CFS. HHS should not consider my letter of opposition as participation or buy-in – because it is not. This is a letter of opposition for the public record.

    Sincerely Yours,

    Gabby Klein
    Flushing, NY

    cc: Francis Collins (NIH), Thomas Frieden (CDC)
  • commented 2015-01-15 09:22:01 -0500
    Dear Secretary Burwell,

    As a person disabled by the neurological disease myalgic encephalomyelitis (ME) for 18 years, I protest the continued interference by the Department of Health and Human Services (HHS) with medical science in defining and developing diagnostic guidelines for diseases.

    The utter folly of choosing inexperienced non-experts outside the field to write about a contested disease is shown in the opening statement of the December 2014 NIH Pathways to Prevention Workshop (P2P) on “Myalgic Encephalomyelitis/Chronic Fatigue Syndrome” Draft Executive Summary:

    “Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a chronic, complex, multi-faceted condition characterized by extreme fatigue and other symptoms that are not improved by rest. The etiology and pathogenesis remain unknown; there are no laboratory diagnostic tests; and there are no known cures.”

    In the first place, it is entirely unclear what the P2P draft report is about. It purports to be about a condition “characterized by extreme fatigue.” However, the neurological disease myalgic encephalomyelitis (ME) is NOT characterized by extreme fatigue. Unexplained fatigue is the characteristic feature of chronic fatigue syndrome (CFS), not myalgic encephalomyelitis (ME). Classic descriptions of the neurological disease ME [Acheson, 1959; Ramsay, 1986] and the 2011 ME International Consensus Criteria (ICC) [Carruthers, 2011] do NOT list fatigue as a diagnostic symptom of the disease – let alone as a characteristic feature of the disease. Therefore, the P2P draft report cannot be about ME. However, the novice authors of the report seem to be unaware this fact and wish to include ME as a part of the undefined condition they are referring to as “ME/CFS” that is “characterized by extreme fatigue.”

    This in the complete 1986 definition of myalgic encephalomyelitis by Dr. A. Melvin Ramsay written after 30 years of carefully observing the disease in hundreds of patients:

    “A syndrome initiated by a virus infection, commonly in the form of a respiratory or gastrointestinal illness with significant headache, malaise and dizziness sometimes accompanied by lymphadenopathy or rash. Insidious or more dramatic onsets following neurological, cardiac or endocrine disability are also recognised. Characteristic features include:

    (1) A multisystem disease, primarily neurological with variable involvement of liver, cardiac and skeletal muscle, lymphoid and endocrine organs.

    (2) Neurological disturbance – an unpredictable state of central nervous system exhaustion following mental or physical exertion which may be delayed and require several days for recovery; an unique neuro-endocrine profile which differs from depression in that the hypothalamic/pituitary/adrenal response to stress is deficient; dysfunction of the autonomic and sensory nervous systems; cognitive problems.

    (3) Musculo-skeletal dysfunction in a proportion of patients (related to sensory disturbance or to the late metabolic and auto immune effects of infection).

    (4) A characteristically chronic relapsing course." [Ramsay, 1986]

    Where’s the “extreme fatigue” that the inexperienced P2P authors claim characterizes “ME/CFS”? It should be clear that whatever “ME/CFS” is in the P2P draft report, it is not ME. Consistent with Ramsay’s classic definition of ME, the 26 highly qualified and experienced professionals who developed the 2011 International Consensus Criteria document, published in the Journal of Internal Medicine, also do NOT include fatigue in the name of the disease or as a criterion for making an ME diagnosis. They state:

    “Using ‘fatigue’ as a name of a disease gives it exclusive emphasis and has been the most confusing and misused criterion. No other fatiguing disease has ‘chronic fatigue’ attached to its name – e.g. cancer/chronic fatigue, multiple sclerosis/chronic fatigue – except ME/CFS. Fatigue in other conditions is usually proportional to effort or duration with a quick recovery and will recur to the same extent with the same effort or duration that same or next day. The pathological low threshold of fatigability of ME described in the following criteria often occurs with minimal physical or mental exertion and with reduced ability to undertake the same activity within the same or several days.”

    The ICC document states ME is characterized by an abnormal biological response to exertion or exercise that is objectively measurable by the 2-day cardiopulmonary exercise test (CPET). [Carruthers, 2011; VanNess, 2007] According to the ICC, “Pain and fatigue are crucial bioalarm signals that instruct patients to modify what they are doing in order to protect the body and prevent further damage.” The fatigue experienced by ME patients is the result of an underlying disease process and cannot be considered as medically unexplained any more than can be the fatigue experienced by cancer and MS patients.

    Why then would the P2P draft report authors include the “ME” part of the term “ME/CFS” that is used apparently to refer to some condition other than ME? The only reason can be because bureaucrats at the Department of Health and Human Services (HHS) told the compliant members of the “unbiased, independent” P2P panel to use the term “ME/CFS” throughout their report and never mind what it means. The only published case definition using the term “ME/CFS” is the 2003 Canadian Consensus Criteria (CCC) document [Carruthers, 2003], but confusingly the P2P draft report uses “ME/CFS” in a broader sense to refer to some nebulous fatigue condition that is never delineated.

    The hybrid term “ME/CFS” explicitly embodies what has been the major problem in the field ever since the CDC dispatched two inexperienced, unqualified investigators to the Lake Tahoe region of Nevada in the fall of 1985 in response to one of the many outbreaks of ME in the 20th century – the conflation of the neurological disease ME with a poorly described, socially constructed syndrome based almost entirely on the unmeasurable, undefinable symptom of perceived fatigue.

    For 26 years after the CDC mischaracterized ME as a fatigue syndrome in 1988, [Holmes, 1988] all patients with ME in the US have been misdiagnosed as part of the CDC’s overly broad chronic fatigue syndrome collection of self-reported symptoms. Simply tacking the term “ME” on to “CFS” using a slash does absolutely nothing to correct this problem. In fact, using “ME/CFS” makes the problem much worse. How can the neurological disease ME ever be separated from the fatigue condition CFS if the two disparate terms are combined in a single term? Of course they can’t be separated. This is why HHS now favors the unclassifiable, undefined term “ME/CFS” and has instructed their “unbiased, independent” P2P panel to use “ME/CFS” exclusively in their report to refer to who knows what.

    If any of the P2P draft report authors had ever attempted to diagnose a patient with “ME/CFS” and consulted the current US ICD-9-CM, used to code diagnoses for billing and reporting purposes, they would find that the hybrid term “ME/CFS” is not listed. Only the diagnostic term “chronic fatigue syndrome” is listed as 780.71 under “Symptoms, Signs, And Ill-Defined Conditions.”

    “ME/CFS” also has never been listed in the World Health Organization’s International Classification of Diseases (ICD). ME, however, has been listed in the WHO ICD as a neurological disease since 1969. Indeed, the hybrid “ME/CFS” diagnostic term can never be legitimately listed in the WHO ICD. It’s an unclassifiable chimera that violates the WHO rule of only using mutually exclusive diagnostic terms that fall within a single category.

    Nor will the hybrid term “ME/CFS” be listed in the upcoming US ICD-10-CM, official October 1, 2015. Only the diagnostic terms “chronic fatigue syndrome” in the general symptoms section and “benign myalgic encephalomyelitis” in the neurological diseases section will be listed. How then will a doctor code an “ME/CFS” diagnosis? Because doctors in the US have only been informed about CFS, if informed at all, and know nothing of ME, “ME/CFS” will be coded as the ill-defined condition CFS and not as the neurological disease ME. This fact renders HHS’s current use of the term “ME/CFS” hypocritical and nonsensical.

    How then is one to interpret such statements in the P2P draft report as, “Patients experience stigma from the diagnosis of ME/CFS, including social isolation and judgment”? How can patients experience stigma from a diagnosis of “ME/CFS” when CFS is the diagnostic term now used by doctors in the US? The draft report is retrospectively calling CFS “ME/CFS.” This muddled historical revisionism is the result of the “unbiased, independent” P2P panel allowing itself to be misguided by HHS bureaucrats.

    Despite obviously not knowing what “ME/CFS” might be, the P2P draft report authors on page 3 make the breathtaking leap of faith to assure readers that “ME/CFS exists.” This is bit like declaring Bigfoot exists despite being unable to come up with a clear description of the creature. However, the confusion of the authors is understandable because their newly acquired knowledge of “ME/CFS” is largely based on a recent Agency for Healthcare Research and Quality (AHRQ) Evidence Report No. 219 “Diagnosis and Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome” [Smith, 2014] also written by “unbiased, independent” neophytes in the field.

    The Executive Summary of the AHRQ Final Evidence Report on page ES-1 makes the egregious misstatement that of the eight published case definitions considered, “All include persistent fatigue not attributable to a known underlying medical condition, as well as additional clinical signs and symptoms.”

    Evidently, the “unbiased, independent” authors of the AHRQ report Executive Summary in their eagerness to make “ME/CFS” all about “persistent fatigue” failed to note that several pages later, the main report states, “All but one of the definitions include persistent fatigue not attributable to a known underlying medical condition, as well as additional clinical signs and symptoms that do not all need to be present to establish the diagnosis.” [Smith, 2014, page 2, italics added]

    Table 2 on page 14 of the AHRQ Evidence Report clearly shows that the one exception that does not use the criterion of fatigue in its case definition is the “International ME Carruthers 2011” case definition in the fourth column from the left. [Carruthers, 2011]

    This omission is vitally important because the neurological disease ME is not a fatigue syndrome, nor a part of any fatigue syndrome. Nevertheless, HHS and their Centers for Disease Control (CDC) have failed to recognize the disease and to list ME as an exclusionary diagnosis for inclusion in the CDC’s broad chronic fatigue syndrome umbrella diagnostic category.

    It can be argued, supported by extensive research, that ME itself is a “known underlying medical condition” to which any fatigue reported by a patient can be attributed. Therefore, ME cannot be considered part of any condition characterized be unexplained fatigue – including ironically HHS’s new undefined “ME/CFS” fatigue illness blend.

    It has been the long-standing policy of HHS to support the misdiagnosis of ME patients with CFS – a policy that spares the private insurance industry the cost of appropriately medically testing for and treating ME. Keeping ME concealed within CFS, and now “ME/CFS,” also spares the Department of Health and Human Services the expense of appropriately funding biomedical research on a major neurological disease. Instead, HHS now gets away with only spending a pittance each year on often social science research of an elusive fatigue condition called CFS.

    HHS wishes to avoid at all costs acknowledging their concealment of ME for decades within CFS. Apparently the “unbiased, independent” P2P report authors are happy to oblige HHS by failing to read any further than the Executive Summary of the AHRQ report and using HHS’s new undefined, catch-all term “ME/CFS” without question.

    The P2P authors naively misrepresent ME in their draft report as a part of a dazzling “complex, multi-faceted condition characterized by extreme fatigue” completely oblivious to the history of ME in the medical literature and its current 2011 ICC case definition. Anyone familiar with the field would have noticed the glaring error on page ES-1 of the AHRQ Evidence Review and pointed it out rather than repeating it.

    If the P2P draft report authors had read the 2012 ME International Consensus Primer (IC Primer or ICP) [Carruthers. 2012], they would know better than to parrot the CDC’s popular myth that “there are no laboratory diagnostic tests” for the disease. The IC Primer already lists over 30 laboratory tests and imaging studies specifically useful in diagnosing ME, in addition to standard laboratory screening tests.

    Despite the P2P draft report’s familiar call that more research is needed, it is completely unclear just what it is that needs to be researched. Research on any actual disease has been hampered for decades by use of the overly broad 1994 Fukuda CFS case definition. [Fukuda, 1994] Fukuda CFS research results cannot be applied to any specific patient group or consistently replicated.

    The P2P draft report completely fails to address the total lack of funding by the National Institutes of Health (NIH) for any research on the neurological disease ME with subjects selected using specific ME criteria. As the IC Primer states, “There is a current, urgent need for ME research using patients who actually have ME.” This urgent need is completely ignored by the authors P2P draft report who were charged with identifying “research gaps and future research priorities.”

    The P2P draft report calls for the 1991 Oxford CFS definition to be “retired.” No mention is made, however, of retiring the CDC’s 1994 CFS Fukuda definition which has also been impairing progress in the field for over 20 years. Does “retiring” the Oxford definition mean the CDC will remove the 2011 PACE trial, which used the Oxford definition, as a reference in their CFS continuing medical education course? The CDC has used the Oxford-based PACE trial to support their irresponsible recommendation of using exercise as "therapy"to treat CFS.

    In fact, “retiring” the Oxford definition means very little in actual practice because Oxford has never been used in NIH-funded CFS research. Will the invalid UK PACE trial be retracted based on the P2P panel’s recommendation? It won’t be. No doubt, the CDC will continue to used Oxford-based research as a reference whenever it supports the CDC’s agenda of recommending primarily behavioral treatments for their chronic fatigue syndrome.

    Unbelievably, to remedy the current chaos caused the use of multiple case definitions, the P2P draft report authors want to “assemble a team of stakeholders (e.g., patients, clinicians, researchers, federal agencies) to reach consensus on the definition and parameters of ME/CFS.” Apparently, the draft report authors are unaware that a consensus of truly independent, expert professionals in the field was reached over 10 years ago in the 2003 Canadian Consensus Criteria (CCC) and updated in 2011 by the International Consensus Criteria (ICC). The ICC have now been used to select subjects with ME for research studies indicating widespread neuroinflammation and immune system abnormalities are associated with the disease. [Nakatomi, 2014; Brenu, 2013]

    However, when then HHS Secretary Kathleen Sebelius was offered the opportunity in 2013 of adopting the compromise CCC case definition as recommended by 50 expert professionals in the field, she summarily rejected the proposal. Instead, HHS is now pursuing a new unneeded redefinition of “ME/CFS” using a contracted Institute of Medicine panel composed mostly of the controllable “unbiased, independent” non-experts favored by HHS bureaucrats.

    Nevertheless, the unknowledgeable P2P panel is calling for yet another grand consensus by a “team of stakeholders” and a pie-in-the-sky “national and international research network.” It should be clear to anyone that the problem is bad faith at HHS, not the lack of existing excellent consensus diagnostic and treatment guidelines that can also be used for research.

    The diagnostic and research criteria for other major diseases are developed by expert professionals in the field and their organizations without inference by government bureaucrats and agencies. The harm caused by governmental meddling with disease criteria is demonstrated by the unscientific 1994 Fukuda CFS criteria controlled and developed primarily by NIH and CDC bureaucrats with major input from UK psychiatrists. These bureaucrats had personal and institutional agendas which they placed above the public interest. [Straus, undated] For two decades the overly broad Fukuda CFS criteria have confounded research and led to the medical neglect and mistreatment of patients.

    ME expert Dr. Byron Hyde wisely observed in a paper presented in New South Wales in 1998:

    “Definitions are not diseases, they are often simply the best descriptions that physicians and researchers can offer, with their always imperfect knowledge, to describe a disease. Good definitions are good because they correspond closely to the disease state being described. It is thus important that those that attempt to define any disease or illness to have long term clinical experience with patients with this illness. There is simply no place for the bureaucrat in defining illness. All definition of epidemic or infectious illness must be based upon persistent clinical examination of the afflicted patient, an understanding and exploration of the environmental factors producing that illness, and pathophysiological examination of tissue from those patients. For similar reasons, I believe that the inclusion of psychiatrists in the defining of an epidemic and obviously disease of infectious origin, simply muddies the water for any serious understanding of that disease.” [Hyde, 1998]

    Yet the naive P2P panel is calling for still more governmental interference in medical science by wanting “federal agencies” to be included in choosing yet another set of criteria for a fatigue condition now called “ME/CFS.” When will professionals realize the harm caused by governmental interference with science and refuse to take part in such efforts? Currently, the only two contemporary case definitions that reflect the physical reality of the disease were developed by professionals in the field with a minimum of of governmental interference – the 2003 CCC and 2011 ICC.

    The unknowledgeable P2P panel from outside the field seems to be unaware that most of the problems the panel has “discovered” have already been addressed by the 2011 ICC and 2012 IC Primer. HHS can begin correcting these problems by recognizing ME as the distinct neurological disease that it is and removing ME from the broader inappropriate CFS category, as called for by the ICC. HHS needs to assume an ancillary role and begin disseminating the IC Primer to doctors so they can make the differential diagnosis of ME, instead of continuing to place ME patients at risk by misdiagnosing them with CFS or some new “ME/CFS” pseudo-diagnosis.

    The tools for educating medical professionals about ME already exists in the ICC and IC Primer. The problem is HHS does not want to devote the necessary resources to educating doctors and healthcare professionals on how to recognize, diagnose, and properly treat ME. HHS prefers, instead, to accept the increased disability in the US population and increased yearly cost to the economy caused by medically neglecting and mistreating ME. The HHS leadership has chosen to support the bureaucrats at the CDC’s inept CFS program, and their negligent CFS Toolkit collection of dangerous medical misinformation, over the public interest. [CDC, undated]

    Why would HHS ever implement any of the grand proposals of the P2P draft report when HHS stubbornly refuses to take even the low-cost, simple step of removing the harmful, inaccurate CFS Toolkit from the CDC website and disseminating the excellent IC Primer to healthcare professionals? Doctors now are unaware of the possible permanent harm to their ME patients posed by exercise and overexertion. ME must be recognized and diagnosed early so the patient can be advised to take total rest to limit the risk of permanent severe disability caused by the disease. Pioneer ME doctor A. Melvin Ramsay has noted:

    “The clinical picture of myalgic encephalomyelitis has much in common with that of multiple sclerosis but, unlike the latter, the disease is not progressive and the prognosis should therefore be relatively good. However, this is largely dependent on the management of the patient in the early stages of the illness. Those who are given complete rest from the onset do well…”

    Doctors have been left totally uninformed about ME by the continued misconduct of HHS bureaucrats. Instead of conducting seminars educating doctors about ME with information that is now readily available, HHS is squandering public money on the obfuscating P2P Workshop and its report which will soon be forgotten. The leadership at HHS has chosen to place their highest priority on protecting the mistakes of their bureaucrats and the profits of the insurance industry rather than protecting the public health.

    The primary consideration of “unbiased, independent” P2P draft report is obviously pleasing the HHS bureaucrats who commissioned the report rather than adding any clarity to the muddled mess created by those very bureaucrats. Any useful suggestions made in the final P2P report will simply be ignored by HHS bureaucrats as they have done for decades. The P2P draft report can hardly be expected to address the main problem currently forestalling any hope of progress in researching, diagnosing, and treating ME – the refusal of HHS to listen to the truly independent and knowledgeable medical and scientific professionals in the field. Instead, HHS continues to enlist controllable non-experts to add more confusion and delay to the field. The P2P draft report itself is a prime example.

    Sincerely,

    Jerrold Spinhirne, S.E.
    Chicago, Illinois

    Further reasons for disseminating the 2012 International Consensus Primer now to healthcare personnel and the medical risks to myalgic encephalitis patients posed by continued misdiagnosis with chronic fatigue syndrome are given in my December 17, 2014 article: Why There Is an Urgent Need to Widely Distribute the Myalgic Encephalomyelitis International Consensus Primer to Doctors.
    https://drive.google.com/file/d/0B4uD-VyWmIw2T3Y2NTNLWjRBeFE/view

    References:

    Acheson, ED. The clinical syndrome variously called benign myalgic encephalomyelitis, Iceland disease and epidemic neuromyasthenia. Am J Med 1959; 26(4):569–595. http://www.name-us.org/DefintionsPages/DefinitionsArticles/Acheson1959.pdf

    Brenu EW, Johnston S et al. Immune abnormalities in patients meeting new diagnostic criteria for chronic fatigue syndrome/myalgic encephalomyelitis. J Mol Biomark Diagn 2013; 4:152.

    Carruthers BM, Jain AK et al. Myalgic encephalomyelitis/chronic fatigue syndrome: Clinical working case definition, diagnostic and treatment protocols. J of Chronic Fatigue Syndr 2003; 11:7-154.

    Carruthers BM, van de Sande MI et al. Myalgic encephalomyelitis: International Consensus Criteria. J Intern Med 2011; 270:327–38. http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2796.2011.02428.x/full

    Carruthers BM, van de Sande MI et al. Myalgic Encephalomyelitis – Adult & Paediatric: International Consensus Primer for Medical Practitioners. Published online October 2012. http://www.name-us.org/DefintionsPages/DefinitionsArticles/2012_ICC%20primer.pdf

    Centers for Disease Control and Prevention. Chronic Fatigue Syndrome: A Toolkit for Providers. Undated. Accessed December 14, 2014. http://www.cdc.gov/cfs/pdf/cfs-toolkit.pdf

    Fukuda K, Straus SE, Hickie I et al. Chronic fatigue syndrome: a comprehensive approach to its definition and study. Ann Intern Med 1994; 12:953–9.

    Holmes GP, Kaplan JE, Gantz NM et al. Chronic fatigue syndrome: a working case definition. Ann Intern Med. 1988; 108:387-389.

    Hyde BM. Paper presented in New South Wales, February 1998. http://www.meactionuk.org.uk/Byron_Hyde_Nightingale_Research_Foundation_Paper.htm

    Nakatomi Y, Mizuno K et al. Neuroinflammation in patients with chronic fatigue syndrome/myalgic encephalomyelitis: An 11C-®-PK11195 PET study. J Nucl Med 2014; 55:1–6.

    Ramsay AM. Myalgic Encephalomyelitis and Postviral Fatigue States: The Saga of Royal Free Disease. 1st ed. London: Gower Medical Publishing; 1986.

    Smith MEB et al. Diagnosis and Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Evidence Report/Technology Assessment No. 219. (Prepared by the Pacific Northwest Evidence-based Practice Center under Contract No. 290-2012-00014-I.) AHRQ Publication No. 15-E001-EF. Rockville, MD: Agency for Healthcare Research and Quality; December 2014. http://www.effectivehealthcare.ahrq.gov/ehc/products/586/2004/chronic-fatigue-report-141209.pdf

    Straus, Stephen. Undated letter on NIH letterhead to Keiji Fukuda quoted and posted online by Craig Maupin in The CFS Report, March 2014, CDC and NIH Officials Discussed “Desirable Outcome” of Seeing a Distinct Illness “Evaporate.” ”http://cfidsreport.com/News/14_Chronic_Fatigue_Syndrome_Definition_IOM_Straus.html">http://cfidsreport.com/News/14_Chronic_Fatigue_Syndrome_Definition_IOM_Straus.html

    VanNess JM, Snell CR, Stevens SR. Diminished cardiopulmonary capacity during post-exertional malaise. J Chronic Fatigue Syndr 2007; 14: 77-85.
  • commented 2015-01-14 20:11:55 -0500
    Dear Secretary Burwell,

    My name is Elaine Boel and I have been sick with ME for over twenty-five years. Three years ago, I was finally diagnosed. Before the diagnosis, my symptoms became very severe—seizures, sub-acute forms of encephalitis, amnesia due to seizures, wasting syndrome, and much more. Having absolutely no idea what was wrong with me, my husband and I spent countless hours researching the possibilities and ultimately discovered the ME Valcyte trials being done at Stanford. After a terrible post-exhersional crash leading to encephalitis (with accompanying aphasia, neuropathy, etc.), I decided to take my chances and swallow an attack dose of Acyclovir instead of facing another humiliating scene at the ER. When that immediately abated the severe brain destruction, my primary physician allowed me to continue this course of treatment until I could be seen by an immunologist. To make a long story short, after several visits to different doctors, we finally got an appointment to see the “best” immunologist in all of Seattle. He told us that no one in the region would ever treat an ME patient with antivirals because they were ideologically opposed to it.

    Which leads me to a particular grievance. I followed closely the P2P proceedings and was happy to see some of our best and brightest physicians represented—Dr. Klimas, Dr Jason, and my own doctor, Dr. Kogelnick to name just a few. At the same time, however, there was Dr. Buchwald sitting on one of the panels and it seemed as if her opinions were given the same weight as these other champions in our field? If you go on Phoenix Rising (the patient forum) and ask how patients feel about their treatment at the Harborview Chronic Fatigue Center in Seattle, you would understand my ire. The psychosocial model of ME is outmoded and we are sick to death of physicians who perpetuate it. If it weren’t for Dr. Buchwald’s “leadership” in this area, I might not have had to travel to Northern California for help. Still, she can boast on her website that the government supports her methods. To quote: "The research program that has grown out of this clinical effort has focused on illuminating the “5 P’s” model of chronically fatiguing conditions: predisposition, precipitants, perpetuators, predictors of chronicity, and perceptual factors involved in the illness. In 1994 Dr. Buchwald and an interdisciplinary group of collaborators were awarded one of three Chronic Fatigue Syndrome Cooperative Research Center grants from the National Institutes of Health. The original Cooperative Research Center involved three cores to support a research effort and four specific research projects. The Cooperative Research Center was renewed in 1999 to support the three cores and pursue an additional four projects."

    My question then is this: how do you expect to win the trust of the patient community when you turn down Ian Lipkin’s mircrobiome initiative or, as Dr. Montoya said, you rejected, more than once, proposals for two of the most significant studies here-to-date, the ones confirming structural and EEG abnormalities in the brain, and instead squander our meager resources to those attempting to find (or should I say create?) an ME “type?” Every newspaper and journal of consequence wrote about the Stanford results. This helped boost awareness. In Seattle, by contrast, patients at the Harborview CFS Center are depicted as people with imaginary pain disorders or, to put it bluntly, narco-seekers.

    Even with this in mind, I do believe that we need “centers of excellence” because so many of us cannot travel. These institutions, however, should NOT be modeled on the Harborview CFS Center. We need institutions that are on the cutting edge of medicine—like the Open Medicine Institute. If there is any way to alienate the ME community and make us militant, it would be by spending more money on these same behavioral/alternative medicine/prevention garbage. We need to find biomarkers, fast track drugs, and set up large-scale double-blind experiments.

    One further criticism: During the P2P proceedings, much of our research was deemed inadequate because it didn’t include enough subjects or it didn’t involve a representative number of minorities, etc. Did anyone else see the irony in that? I mean, how are our doctors expected to conduct large-scale studies with only a handful of coins? More importantly, how are researchers supposed to include minorities when even most practitioners have never heard of ME? There has to be an outreach in minority communities and education for providers, patients and possible patients. Has it ever occurred to anyone that the estimated one million people with ME in the US might be twice or three times that amount because of it being so underreported? Would it be farfetched to wonder if pediatric ME might not be contributing to lower rates of high school graduation in this country?

    I have been very lucky to land at the Open Medicine Institute. I have been lucky to respond to antivirals and to have undergone a short remission. We are hopeful that this can be replicated and that, with careful living, I can hold onto it for some time. This summer, when I was better because of Valcyte, I was able to paddle board every day. Carefully. Even so, I would never, ever promote exercise therapy for ME patients. When we have active brain inflammation, exercise is very dangerous and can even be fatal. It should be up to us to choose when we take up activity and up to us to decide whether or not meditation and other alternative practices may benefit us. These should be considered complimentary medicine and not an answer. We need answers.

    And, before I get off this soapbox, I would like to add that the name “chronic fatigue” is completely inappropriate. For many of us, fatigue does not figure in the top categories of symptoms and it isn’t really fatigue as much as narcolepsy or paralysis or a form of post-orthostatic tachycardia syndrome. Furthermore, PEM is a ridiculous term too. We need to follow Dr. Kimas’ lead in this and start calling it post-exhersional crash.

    Thank you for taking the time to read this. I am someone who, while opposed to this entire IOM, P2P process, would like to see the government reversing its bad record on ME. I could tell that our concerns weren’t entirely dismissed at the conference and that gave me hope. Please do the right thing—increase our budget substantially, listen to patients, and find out who they think should be receiving research funds. The next few years will be pivotal with regard to this disease. You don’t want to be on the wrong side of this issue.

    Sincerely yours,
    Elaine Boel
  • commented 2015-01-14 16:58:20 -0500
    Public comment on the P2P Draft Statement by Katharina Voss, Dec 2014:
    (Corresponding line numbers of the report are shown here in parentheses, reference numbers are shown here in brackets)

    What does the NIH leadership really think about our disease?

    „They hate you!“

    This was the answer of a retired NIH scientist to a patient at a medical conference in New York City, Dec 2013. 1 And his answer was the first and only honest answer patients with ME ever got from NIH. This NIH scientist frankly expressed what patients with ME undergo every single day: they face a wall of hatred and scorn.

    The NIH P2P Draft Statement clearly shows that he was right.

    As many of ME activists predicted we got just the same bad recommendations given to Gulf war veterans (whose disease was “redefined” into the belittling “CMI”) and fibromyalgia patients. 2 NIH wants to put us off with ineffective harmful treatments like GET, CBT, antidepressants, and self-management. (Lines 113-116, 135-138, 344-350, 370-371)

    Self-management – have we read correctly? What else are we doing now for decades in the absence of proper medical care? Self-management! And the NIH spends millions of taxpayers` dollars to recommend self-management? Are you kidding us?

    These treatments like GET, CBT, antidepressants, and self-management ("multimodal therapy“) could possibly be effective for some psychological disorders, but they do harm to patients with organic diseases like ME, a fact that is proven by true science but which is rejected by the P2P "experts“! 3

    Why does NIH neglect patients with ME?

    Although men are also affected the majority of ME patients are women. Hence this neglect is clearly a case of misogyny! I want to compare the situation with the early AIDS epidemic when mainly gay men fell ill and were discriminated against as homosexuals and AIDS was called “gay plague”, "Gay Related Immune Deficiency“ (GRID), "Gay People’s Immuno Deficiency Syndrome“ (GIDS), the CDC`s creation “the 4H disease” (Haitians, homosexuals, hemophiliacs, heroin users)]. 4 Racism, homophobia and misogyny impeded research much too long.

    Today there is a big problem with the so-called "medically unexplained syndromes“, a term created by psychiatrists in order to cover and falsely include a lot of physical diseases. These psychiatrists – mostly the same psychiatrists who recommend CBT, GET and antidepressants for patients with “ME/CFS” – try to “prove” that exposure to childhood trauma is associated with significantly increased risk of “ME/CFS”. They try to “prove” that sexual abuse, emotional abuse and emotional neglect cause “ME/CFS”, and that these factors were most effective in distinguishing “ME/CFS” cases from healthy controls. 5 They try to “prove” this unscientific nonsense inspite of the very well-known results of biomedical research.

    Their unscientific work results in falsely accusing mothers of children with ME of having a Munchausen by proxy syndrome. Parents, falsely accused of sexual abuse, emotional abuse and emotional neglect or of Munchausen by proxy syndrome lose custody and many children with ME have been separated from their families. They were mistreated with GET in psychiatric wards and their parents were wrongly criminalized. This is an ongoing praxis and this happens all due to the disregard of an organic disease. 6

    All these so-called "medically unexplained syndromes“ which are in reality physical diseases affect more women than men. Women are probably genetically more susceptible for these diseases. Actually these diseases are not psychological disorders and many biomedical abnormalities can be measured for diseases like ME, fibromyalgia and so on, falsely labeled as "medically unexplained syndromes“.

    We must not assume that these psychiatrists who assert that all these diseases are medically unexplained and caused by sexual abuse, emotional abuse and emotional neglect are stupid. We have to assume that they are well familiar with the results of biomedical research. Therefore, it is a deliberate misrepresentation by these psychiatrists, driven by misogyny.

    This intentional misrepresentation is a violation of the AMERICAN DECLARATION OF THE RIGHTS AND DUTIES OF MAN, a violation of article I (Right to life, liberty and personal security), article VII (Right to protection for mothers and children), article XI (Right to the preservation of health and to well-being).

    NIH consistently denies the fact that ME is an infectious disease.The report encourages more biopsychosocial studies. (Lines 275-276) Is that really what we need? More of these biopsychosocial studies from Wessely School and their worldwide followers which will “prove” that ME is a mental illness perpetuated by our “false illness beliefs”? No, we don`t need any single further study of this kind!

    Why is NIH consistently denying the fact that ME is an infectious disease? There are so many clusters in families and among fellow workers and pupils proving that ME is indeed infectious. 7 Why is NIH hiding this very well-known fact? No actions have been taken to stop this epidemic. Why? A disease which was ""[not] numerically important on a national scale““ in the fifties has now evolved into the "most common chronic disease of young and middle-aged adults“ because NIH failed to recognize its epidemic character. 8

    Everyone who is able to read can read that Mikovits and Ruscetti found uncontaminated retroviral variants other than XMRV. Those variants were not XMRV. 9

    Only figure 1 of the Science paper was wrong. Figure 1 was the XMRV PCR sequencing/naming done by Silverman. Silverman was the one who sequenced XMRV in his lab, and these are the PCR data shown in figure 1 in the Science paper. 10

    All the other data on the Science paper still stand. 11 The serology information is well documented. The research also showed the dysfunctional immune profile, the cytokine signature, and microarray co-pathogens associated with those who were antibody positive in several studies. This data is all published. 12

    The prostate cancer paper by Silverman falsely claimed XMRV to be a human infection and was later retracted. However, no research came to a halt for prostate cancer because of Silverman`s error. Contrary to Dr. Judy Mikovits Silverman still has his career and the prostate cancer patients are still provided with research and treatment.

    However, because of the original mistake made in XMRV prostate cancer research the ME patient population has been denied further research on Mikovits/Ruscettis original results and effective treatment. Silverman was wrong yet ME patients and Dr. Judy Mikovits are paying the price for his mistake.

    And by the way, what about Maureen Hansons findings, her detection of MLV-like gag sequences in blood samples from a patient cohort? 13

    What about Sidney Grossberg`s isolation of the JHK retrovirus in ME patients? 14

    And what about Elaine De Freitas` HTLV II-like retroviral sequences found in ME patients? 15 Why had the CDC never tried to follow her protocol? 16

    Why did the NIH continue refusing unbiased and true science? Why did the NIH destroy future research for our disease because of the XMRV mistake made in prostate cancer? Why is NIH not pursuing the research for the variants and serology found in Ruscetti’s lab? Why did the NIH destroy the hope of millions ME sufferers for effective antiretroviral, antiviral and anti-inflammatory treatments?

    Shall my beloved daughters never have a life? Both developed mild ME, at least at the age of three. The elder one lost 2 years of education due to her disease before she got completely bedbound, the younger one lost nearly a whole year of education before she got bedbound. In 2009 my elder daughter received a Boostrix shot (polio, tetanus, dyphtheria) followed by a very severe relapse which continues to date. (100% bedbound, spoonfed, unable to wash, to brush her teeth without help, touch-sensitive, sensitive to the slightest noise and often unable to bear the presence of their beloved family members even for only a few minutes) In January 2011 my younger daughter relapsed after a series of viral infections. Being 90% bedbound, suffering from severe neurological and neurocognitive problems she is too severely affected to participate in any form of education, even at home. (My daughters are just the most severely affected members of our family! Many have/had other neuroimmunological diseases or/and cancer.)

    My daughters clearly don`t suffer from a syndrome "characterized by extreme fatigue“ as "ME/CFS“ is described in the P2P draft. (Lines 2-4) My daughters suffer from a disease characterized by postexertional neuroimmune exhaustion (PENE). And PENE "is part of the body’s global protection response“ in a disease named Myalgic Encephalomyelitis in the fifties, recognized as a neurological disease from WHO in 1969. 17

    PENE, the cardinal symptom of ME, is an objectively measurable (i.e. Two-day Cardiopulmonal Exercise Test) abnormal biological response to exertion. 18 ME is not characterized by a subjective feeling of fatigue. Fatigue can be an accompanying symptom but many ME sufferers never experience fatigue. But every real ME sufferer experiences PENE. Without PENE – no ME!

    My elder daughter is now 21 years old and spent 5 ½ years in a darkened room with no hope to ever get out of there. When will NIH research release her from prison? The younger one is now 14 years old, being severely ill nearly one third of her young life!
    Both girls lost half of their childhood due to mild ME and her whole youth due to very severe ME. But all the NIH has to offer is self-management? Will NIH not allow them to have a future?

    Oh yes, all the tests, medications and medical care we really need (and some of us probably lifelong) would be costly if the NIH would actually recognize ME as an infectious and transmissible disease.

    But what is the alternative? The alternative is that we will further spread this disease. And many of our beloved ones will contract this disease, our friends and carers and physicians. And this disease will not stop in front of the doors of NIH.

    Wake up, NIH! Break down the wall of hatred and scorn!

    Wake up, America!

    Thank you for your attention!

    References
    1 Heckenlively, Kent, Mikovits, Judy "Plague: One Scientist’s Intrepid Search for the Truth about Human Retroviruses and Chronic Fatigue Syndrome, Autism, and Other Diseases”. Foreword by Hillary Johnson, p. xxi, Skyhorse Publishing 2014
    2 “Gulf War and Health Volume 9 Treatment for Chronic Multisymptom Illness”, Institute of Medicine
    3 Snell, Christopher R., Stevens, Staci R., Davenport, Todd E., and Van Ness, J. Mark “Discriminative Validity of Metabolic and Workload Measurements to Identify Individuals With Chronic Fatigue Syndrome”, published online before print 27 June 2013 doi: 10.2522/ptj.20110368
    VanNess JM, Stevens SR, Bateman L, Stiles TL, Snell CR “Postexertional malaise in women with chronic fatigue syndrome.” J Womens Health (Larchmt). 2010;19:239-44
    VanNess JM, Snell CR, Stevens S “Diminished Cardiopulmonary Capacity During Post- Exertional Malaise.” J Chronic Fatigue Syndr. 2008;14(2):77-85
    Nijs J1, Almond F, De Becker P, Truijen S, Paul L “Can exercise limits prevent post-exertional malaise in chronic fatigue syndrome? An uncontrolled clinical trial.” Clin Rehabil. 2008 May; 22(5):426-35. doi: 10.1177/0269215507084410
    LaManca JJ, Sisto SA, DeLuca J, Johnson SK, Lange G, Pareja J, Cook S,Natelson BH. “Influence of exhaustive treadmill exercise on cognitive functioning in chronic fatigue syndrome.” Am J Med. 1998 Sep 28;105(3A):59S-65S
    VanNess JM, Snell CR, Stevens SR, Stiles TL “Metabolic and neurocognitive responses to an exercise challenge in chronic fatigue syndrome/(CFS)”, Med Sci Sports Exerc. 2007
    White AT, Light AR, Hughen RW, Bateman L, Martins TB, Hill HR, Light KC. “Severity of symptom flare after moderate exercise is linked to cytokine activity in chronic fatigue syndrome.” Psychophysiology. 2010 Jul 1;47(4):615-24. doi: 10.1111/j.1469-8986.2010.00978.×.
    Twisk FNM, Maes M “A review on Cognitive Behavorial Therapy (CBT) and Graded Exercise Therapy (GET) in Myalgic Encephalomyelitis (ME)/Chronic Fatigue Syndrome (CFS): CBT/GET is not only ineffective and not evidence-based, but also potentially harmful for many patients with ME/CFS.” Neuro Endocrinol Lett. 2009;30:284-299
    Cooper DM, Radom-Aizik S, Schwindt CD, Zaldivar F. “Dangerous exercise: lessons learned from dysregulated inflammatory responses to physical activity.” J Appl Physiol. 2007;103:700–709.
    Vermeulen, Ruud CW and Vermeulen van Eck, Ineke WG “Decreased oxygen extraction during cardiopulmonary exercise test in patients with chronic fatigue syndrome“, Journal of Translationa Medicine 2014, 12:20 doi:10.1186/1479-5876-12-20
    Light AR, White AT, Hughen RW, Light KC “Moderate exercise increases expression for sensory, adrenergic, and immune genes in chronic fatigue syndrome patients but not in normal subjects.” J Pain. 2009;10:1099-112
    Kindlon, Tom ”Reporting of Harms Associated with Graded Exercise Therapy and Cognitive Behavioural Therapy in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome”, Bulletin of the IACFS/ME. 2011;19(2): 59-111. ”http://www.iacfsme.org/LinkClick.aspx?fileticket=Rd2tIJ0oHqk%3D&amp">http://www.iacfsme.org/LinkClick.aspx?fileticket=Rd2tIJ0oHqk%3D& (12/25/2014)
    Bringsli, Gunn J., Gilje, Anette and Getz Wold, Bjørn K. “THE NORWEGIAN ME ASSOCIATION NATIONAL SURVEY Abridged ENGLISH VERSION“, http://me-foreningen.com/meforeningen/innhold/div/2014/05/ME-Nat-Norwegian-Survey-Abr-Eng-Ver.pdf (12/25/2014)
    4 “AIDS“, ”http://en.wikipedia.org/wiki/HIV/AIDS#Discovery">http://en.wikipedia.org/wiki/HIV/AIDS#Discovery (12/25/2014)
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    “Ronald Reagan Remembered: First Public Discussion of HIV/AIDS“ ”http://www.thebody.com/content/art31696.html">http://www.thebody.com/content/art31696.html (12/25/2014)
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    6 Colby, Jane “False Allegations of Child Abuse in Cases of Childhood Myalgic Encephalomyelitis (ME)”. http://www.argumentcritique.com/uploads/1/0/3/1/10317653/colby_j.pdf (12/25/2014)
    7 Dowsett EG, Colby J. “Longterm sickness absence due to ME/CFS in UK schools: an epidemiological study with medical and educational implications.” J CFS 3(2):2942, 1997, http://www.tymestrust.org/pdfs/dowsettcolby.pdf (12/25/2014)
    Underhill, Rosemary A., O`gorman, Ruth “Prevalence of Chronic Fatigue Syndrome and Chronic Fatigue Within Families of CFS Patients”, Journal of Chronic Fatigue Syndrome 2006, Vol. 13, No. 1, Pages 3-13, http://informahealthcare.com/doi/abs/10.1300/J092v13n01_02 (12/25/2014)
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    Johnson, Hillary "Osler’s Web: Inside the Labyrinth of the Chronic Fatigue Syndrome Epidemic”, p. 203, Penguin Books 1997
    9 Lombardi VC, Ruscetti FW, Das Gupta J, Pfost MA, Hagen KS, Peterson DL, Ruscetti SK, Bagni RK, Petrow-Sadowski C, Gold B, Dean M, Silverman RH, Mikovits JA “Detection of an infectious retrovirus, XMRV, in blood cells of patients with chronic fatigue syndrome”, Science. 2009 Oct 23;326(5952):585-9. doi: 10.1126/science.1179052.
    Goetz, Deborah L. S., Mikovits, Judy A., Deckoff-Jones, Jamie and Ruscetti, Francis W. "INNATE IMMUNE CHANGES IN THE PERIPHERAL BLOOD OF CHRONIC FATIGUE SYNDROME PATIENTS: RISK FACTORS FOR DISEASE PROGRESSION AND MANAGEMENT“, Chapter VI (pp. 91-130) in “Chronic Fatigue Syndrome”, Nova Science Publishers, Inc. 2014, ISBN: 978-1-63321-961-8
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    12 Goetz, Deborah L. S., Mikovits, Judy A., Deckoff-Jones, Jamie and Ruscetti, Francis W. "INNATE IMMUNE CHANGES IN THE PERIPHERAL BLOOD OF CHRONIC FATIGUE SYNDROME PATIENTS: RISK FACTORS FOR DISEASE PROGRESSION AND MANAGEMENT“, Chapter VI (pp. 91-130) in “Chronic Fatigue Syndrome”, Nova Science Publishers, Inc. 2014, ISBN: 978-1-63321-961-8
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    18 Snell, Christopher R., Stevens, Staci R., Davenport, Todd E., and Van Ness, J. Mark “Discriminative Validity of Metabolic and Workload Measurements to Identify Individuals With Chronic Fatigue Syndrome”, published online before print 27 June 2013 doi: 10.2522/ptj.20110368
    White AT, Light AR, Hughen RW, Vanhaitsma TA, Light KC. “Differences in metabolite-detecting, adrenergic, and immune gene expression after moderate exercise in patients with chronic fatigue syndrome, patients with multiple sclerosis, and healthy controls.” Psychosom Med. 2012 Jan;74(1):46-54. doi: 10.1097/PSY.0b013e31824152ed
  • commented 2015-01-14 16:49:28 -0500
    I am too ill to launch myself into a cogent argument today. I see two excellent comments below, and wish only to endorse the same, with a plea to use your powers sensibly, in accord with the needs of this worthy population, as perceived by those of us suffering with this overwhelmingly disruptive illness. I appeal to you to waste no more time, and to perpetrate no more mistreatment and neglect. The ongoing abuse of patients in this area of medicine is unmatched, and unconscionable, to say the least.
  • commented 2015-01-14 16:20:10 -0500
    I would like to see several federally funded regional ME Centers of Excellence established that would conduct research from bench to bedside as well as provide clinical care to patients.
  • commented 2015-01-14 15:27:38 -0500
    SAMPLE P2P Opposition RESPONSE:

    Feel free to copy/paste or modify, and re-send to the govt. email addresses listed at the bottom of my letter.

    My response is a compilation/blend of several advocates who have written amazing responses already…Gabby Klein, Jeannette Burmeister, Eileen Holderman, Jim Ellsworth, Jarrold Spinhirne.

    I have decided not to submit via the official Public Comment because I do not want it to count as buy-in. I am boycotting the P2P/IOM, but I still want my voice to be heard, so I have emailed the following letter to US Health Secretary Sylvia Burwell and CC’d several other govt. officials listed after the letter:

    Subject Title: Response to P2P for M.E.

    January 14, 2015

    Dear Secretary Burwell,

    My name is Tom Jarrett and I have been sick and disabled by Myalgic Encephalomyelitis (M.E.) for 8 long and difficult years.

    I am a real person. Please keep that in mind.

    I am writing to state my complete opposition to the Health and Human Services (HHS) initiatives involving the Institute of Medicine (IOM) and Pathways to Prevention (P2P) to redefine the disease properly known as M.E. but that HHS has begun improperly referring to as ME/CFS.

    I join multitudes of M.E. advocates, patients, caregivers, researchers and clinicians, and other stakeholders, in total opposition to the IOM and P2P initiatives.

    Together we are united in stating the following:

    We do not need HHS bureaucrats who are not M.E. experts to redefine this disease.

    We do not need more Government-sponsored clinical and/or research definitions for “ME/CFS

    We do not need more Government waste of taxpayer dollars on corrupt initiatives to redefine a disease that has been correctly defined.

    We do not need more Government misinformation about “ME/CFS” disseminated to physicians, health insurance carriers, the public, and the press.

    Here is what we DO need and what we DO demand:

    1) Adopt the CCC now (http://www.mefmaction.com/images/stories/Medical/ME-CFS-Consensus-Document.pdf), with an open mind toward the ICC (http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2796.2011.02428.x/full)
    2) Widely Distribute the 2012 ME IC Primer to Doctors (http://www.name-us.org/DefintionsPages/DefinitionsArticles/2012_ICC%20primer.pdf)
    3) Increase funding for biomedical M.E. research to match diseases of similar cost and disability burdens

    Here are my supporting arguments for what is needed, and my reasons for opposing the entire P2P process for M.E.:
    M.E. experts have already reached consensus on the definition question. By pursuing a different way (P2P/IOM), and judging by the anti-patient manner in which they are pursuing it, HHS is revealing a harmful ulterior motive. (http://thoughtsaboutme.com/2014/09/03/us-district-court-hhsnih-violated-federal-law-in-response-to-foia-request-for-iom-documents/)

    HHS/NIH should listen to the more than 50 M.E. expert researchers and clinicians who sent an open letter on Sept. 23, 2013 to then U.S. Health Secretary Kathleen Sebelius, stating in part:
    “adopt the 2003 Canadian Consensus Criteria (CCC) as the case definition for this disease.

    We strongly urge the Department of Health and Human Services (HHS) to follow our lead by
    using the CCC as the sole case definition for ME/CFS in all of the Department’s activities
    related to this disease.

    The expert biomedical community will continue to refine and update the case definition as
    scientific knowledge advances; for example, this may include consideration of the 2011 ME
    International Consensus Criteria (Carruthers et al, Journal of Internal Medicine, 2011). As
    leading researchers and clinicians in the field, however, we are in agreement that there is
    sufficient evidence and experience to adopt the CCC now for research and clinical purposes,
    and that failure to do so will significantly impede research and harm patient care."

    View the full letter, signed by more than 50 M.E. experts, endorsed by over 170 leading patient advocates, and backed by nearly 10,000 petition signatures.
    (https://dl.dropboxusercontent.com/u/89158245/Case%20Definition%20Letter%20final%2010-25-13.pdf)

    But the HHS refused to follow the experts’ advice and foolishly/selfishly/secretly embarked on a million dollar Institute of Medicine (IOM) contract and a separate Pathways to Prevention (P2P) process to redefine M.E. to their own liking. They defended the plan to use the IOM by misrepresenting a recommendation from the HHS’s Chronic Fatigue Syndrome Advisory Committee (CFSAC).

    In short, HHS hijacked the CFSAC recommendation.

    The real recommendation was “CFSAC recommends that you will promptly convene (by 12/31/12 or as soon as possible thereafter) at least one stakeholders’ (Myalgic Encephalomyelitis (ME)/Chronic Fatigue Syndrome (CFS) experts, patients, advocates) workshop in consultation with CFSAC members to reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS beginning with the 2003 Canadian Consensus Definition for discussion purposes.”

    In this letter, I will focus on the problem of NIH’s Pathways to Prevention (P2P) initiative and its resulting flawed P2P draft report, which I fully oppose.

    NIH inexplicably decided on using the P2P process for the controversial disease “ME/CFS”. However, the P2P process, as per its website is not to be used for “controversial topics.” That is a blatant violation by itself, but is only the beginning of a fatally flawed process.

    Trans-NIH ME/CFS Research Working Group Chair Susan Maier described the P2P workshop as based on the “jury model” that requires the exclusion of any clinician or researcher who has any experience with M.E.

    Fellow M.E. patient and advocate Jeannette Burmeister called it “the jury model stood on its head” and went on to say:
    “Experts and government officials with varying points of view will present their views at the workshop…Then the P2P panel, made up—by design—of those with no expertise or prior research or opinions on [M.E.] AT ALL, will take the evidence report and the comments of the presenters—the “prosecution” and the “defense”— and deliberate and issue their recommendations in writing within [a week]…I find it hard to capture in words the absurdity of this approach.”
    (http://thoughtsaboutme.com/2014/02/07/p2p-patients-to-purgatory-or-the-jury-model-stood-on-its-head/)

    When NIH stubbornly moved forward with P2P, a protest with wide community support was held to oppose the NIH’s Dec. 9 and 10 P2P workshop.
    (http://www.prohealth.com/me-cfs/library/showarticle.cfm?libid=19443)

    This absurd P2P process culminated in a Draft Executive Summary report released to the public on December 18, 2014.

    This P2P draft report is a crumb, and I will not accept it. Instead, give me the 2012 IC Primer. The IC Primer language (written by actual M.E. experts more than 2 years ago!) is far superior to this P2P report regarding descriptions of M.E. and the manner in which it outlines the needs for future research and funding. NIH could have and should have avoided the monumental waste of time, energy, and tax dollars used to produce the bogus and inferior P2P report.

    HHS/NIH are playing games with us, and our suffering grows.

    Between P2P and IOM, the NIH is forcing a process on us that is more costly, more draining on patients, and with a much longer wait for valid research than if they simply put their full weight and effort into expediting the recommendations from our experts to use the CCC now for diagnostic and research purposes, to widely disseminate the IC Primer to properly educate doctors on the disease M.E., and to dramatically increase funding into biomedical M.E. research to bring it to a commensurate level with MS and other diseases with similar cost and disability burdens to patients and the U.S. economy.

    In addition to rejecting the P2P draft report and the contrived process used to create it, fellow patient Jim Ellsworth makes a powerful and eloquent argument for increased funding into legitimate M.E. research, “We do not need more government reports, conferences, or ‘stakeholder meetings.’ We need cash for research. That’s all that’s needed. Everything else is just re-arranging deck chairs on the Titanic.”
    (http://forums.phoenixrising.me/index.php?threads/the-p2p-draft-report-is-out.34480/page-34#post-544767)

    To help conclude my argument for opposing P2P/IOM, I offer the following excerpts from fellow M.E. patient Jerrold Spinhirne’s public comment for the January 13, 2015 CFSAC Meeting.
    (https://drive.google.com/file/d/0B4uD-VyWmIw2b1pXMzZOZWVUUE0/view?pli=1)

    His essay stunningly illustrates the numerous problems with the P2P process, while helpfully pointing to a beneficial alternative in widely disseminating the 2012 IC Primer to healthcare professionals.

    “ME expert Dr. Byron Hyde wisely observed in a paper presented in New South

    Wales in 1998:

    ’Definitions are not diseases, they are often simply the best descriptions

    that physicians and researchers can offer, with their always imperfect

    knowledge, to describe a disease. Good definitions are good because they

    correspond closely to the disease state being described. It is thus important

    that those that attempt to define any disease or illness to have long term

    clinical experience with patients with this illness. There is simply no

    place for the bureaucrat in defining illness.

    All definition of epidemic or infectious illness must be based upon persistent clinical

    examination of the afflicted patient, an understanding and exploration of the environmental

    factors producing that illness, and pathophysiological examination of

    tissue from those patients. For similar reasons, I believe that the inclusion

    of psychiatrists in the defining of an epidemic and obviously disease of

    infectious origin, simply muddies the water for any serious understanding of

    that disease.’ [Hyde, 1998. Emphasis added]

    The unknowledgeable P2P panel from outside the field seems to be unaware that

    most of the problems the panel has “discovered” have already been addressed by

    the 2011 ICC and 2012 IC Primer. HHS can begin correcting these problems by

    recognizing ME as the distinct neurological disease that it is and removing ME

    from the broader inappropriate CFS category, as called for by the ICC. HHS needs

    to assume an ancillary role and begin disseminating the IC Primer to doctors

    so they can make the differential diagnosis of ME, instead of continuing to

    place ME patients at risk by misdiagnosing them with CFS or some new "ME/

    CFS" pseudo-diagnosis.

    The tools for educating medical professionals about ME already exists in the ICC

    and IC Primer. The problem is HHS does not want to devote the necessary

    resources to educating doctors and healthcare professionals on how to

    recognize, diagnose, and properly treat ME. HHS prefers, instead, to accept

    the increased disability in the US population and increased yearly cost to

    the economy caused by medically neglecting and mistreating ME. The HHS

    leadership has chosen to support the bureaucrats at the CDC’s inept CFS program,

    and their negligent CFS Toolkit collection of dangerous medical misinformation,

    over the public interest. [CDC, undated]

    Why would HHS ever implement any of the grand proposals of the P2P draft

    report when HHS stubbornly refuses to take even the low-cost, simple step

    of removing the harmful, inaccurate CFS Toolkit from the CDC website and

    disseminating the excellent IC Primer to healthcare professionals? Doctors now

    are unaware of the possible permanent harm to their ME patients posed by exercise

    and overexertion. ME must be recognized and diagnosed early so the patient can

    be advised to take total rest to limit the risk of permanent severe disability caused

    by the disease.

    Doctors have been left totally uninformed about ME by the continued misconduct

    of HHS bureaucrats. Instead of conducting seminars educating doctors about ME

    with information that is now readily available, HHS is squandering public money

    on the obfuscating P2P Workshop and its report.

    Further reasons for disseminating the 2012 International Consensus Primer now

    to healthcare personnel (and the medical risks to [M.E.] patients

    posed by continued misdiagnosis with chronic fatigue syndrome) are given in my

    December 17, 2014 article: ’Why There Is an Urgent Need to Widely Distribute the

    Myalgic Encephalomyelitis International Consensus Primer to Doctors.’"
    (https://drive.google.com/file/d/0B4uD-VyWmIw2T3Y2NTNLWjRBeFE/view?pli=1)

    End Public Comment from Jerrold Spinhirne, S.E.

    My opposition to IOM and P2P is a complete rejection of these initiatives to redefine M.E.

    HHS should not consider my letter of opposition as participation or buy-in – because it is not. This is a letter of opposition for the public record.

    Sincerely,

    Thomas W. Jarrett
    M.E. Patient and Advocate
    US Citizen

    To: Sylvia.Burwell@hhs.gov (HHS Secretary)

    cc:
    Francis.Collins@nih.hhs.gov (NIH Director)
    Tomfrieden@cdc.gov (CDC Director)

    Other key government employees involved with the P2P:
    Susan.Maier@nih.hhs.gov (Chair, Trans-NIH ME/CFS Research Working Group)
    David.Murray2@nih.hhs.gov (Director, Office of Disease Prevention)
    Wanda.Jones@hhs.gov (Deputy Assistant Secretary for Health)