Home - What is M.E.?

1 million Americans and 17 million worldwide affected by one of the most disabling diseases ever...

 

Myalgic encephalomyelitis (ME), is a complex disease involving profound dysregulation of the central nervous system (CNS) and immune system, dysfunction of cellular energy metabolism and ion transport as well as cardiovascular abnormalities. The disease affects people of all ages, genders, races and economic levels.

Stories

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Tom developed severe ME following a viral illness in January of 2014. A sophomore at Stanford, Tom was a 4.0 computer science student with a dream research elective and summer job offers at Facebook and Dropbox.

Due to his severe illness, he has been unable to work a job or complete his education. He has been bedridden 23-24 hours a day, not able to read other than a brief occasional message, and conversations are limited.

He is likely to be permanently disabled unless research finds a cure.

 

Tracey S.

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Tracey suddenly became sick in 1989 at age 15 with a triple hit of a stomach virus, pneumonia and mononucleosis. Though the infections cleared, she remained severely ill and housebound. She gradually improved over 5 years - while not completely healthy, she became functional enough to complete a college degree, work full time and get married.

Then, viral infections and an adverse vaccine reaction set off a series of relapses over the next several years. She made drastic lifestyle changes to allow time to rest, and this was helpful to achieve remissions.

However, 10 years ago a progressive decline began, and she became completely disabled and no longer able to work. Her parents moved nearby so her mother (now semi-retired) could take care of Tracey and her children. At age 37 Tracey was diagnosed and treated for Non-Hodgkins Lymphoma (ME patients have an increased risk of cancer).

In all, Tracey has been sick with ME for 26 years. She is homebound and 80-90% bedridden, and has difficulty with self care.

Common misconceptions of the disease

It Is Not Typical Fatigue

The main misconception is that it is similar to the kind of fatigue that normal people feel and that getting proper sleep, eating right, and exercise will cure it.

It Is Not Laziness

Another misconception is that if people don't get well, it's their own fault for being lazy and not trying hard enough. Or that at one point people were sick with some virus, but now they're well - they're just afraid to exercise - so antidepressants and talk therapy will cure them.

ME Is A Serious Neuroimmune Disease

The truth is these people have a very serious neurological disease which impacts the body’s energy production system at the cellular level via dysregulation of the immune and nervous systems --- they need to pace themselves and rest or they will get worse (possibly much worse). You can’t exercise your way out of this disease. It is not uncommon to hear of people who went from being able to work to being permanently bedridden because they tried to push through their symptoms.

Frequently Asked Questions

What is chronic fatigue syndrome (CFS)?

Although ME is recognized as a neuroimmune disease around the world, in the US, governmental health agencies redefined ME as “chronic fatigue syndrome” (CFS). CFS is a political and social construct consisting of a fatiguing psychological illness which purportedly can be resolved with cognitive behavioral therapy (CBT) and graded exercise therapy (GET). This was done to satisfy various lobbies such as psychiatrists and insurance companies. In other words, it’s not based in science.

Since ME has currently not been officially recognized or widely known in the US, it is very hard to get an ME diagnosis. The best medical diagnosis that a patient can expect will likely be CFS or fibromyalgia, while in reality, approximately 50% of these patients actually have ME. Treatments recommended for CFS or fibromyalgia, such as graded exercise, are not beneficial or advised for ME patients. This problem has been the cause of much suffering for ME patients.

Is ME same as CFS?

No - patients who fit the criteria for ME also fit the criteria for CFS. But patients who fit the overly broad criteria for CFS may not fit the criteria for ME.

Why is ME not getting attention?

Neglect

Again this is complicated, but due to the government's institutional bias against the disease, ME has been mishandled and not taken seriously. They renamed the disease a very trivializing name "chronic fatigue syndrome", and have created a series of very loose definitions, misdiagnosing people who actually have depression, multiple sclerosis or other diseases with overlapping symptoms. This makes progress with research difficult because they are studying several diseases, not "the" disease.

Rebranding

The recently proposed new name and definition, “systemic exertion intolerance disease”, is basically deja vu all over again. A recent study by Leonard Jason has shown that the proposed name and definition is almost 3 times looser than the existing 1994 CFS definition, and not nearly as good as already existing definitions created by ME disease experts. The government refuses to adopt these other definitions (for example, the Canadian Consensus Criteria, already in use in Canada).

Lack of Funding

In addition, the federal research budget has been a paltry $5 million per year for the last 25 years, which is at the bottom of the list of diseases. The disease needs to be funded at $250 million annually to get on par with similar diseases.

Why is it so important that ME gets attention?

Extremely Poor Quality of Life

A recent study by Michael Falk Hvidberg has shown that someone with ME has the worst quality of life out of 20 major diseases - even worse than multiple sclerosis and stroke.

The disease affects about 1 million Americans and 17 million worldwide - two to three times the rate of multiple sclerosis. There are no FDA approved treatments, no cause and no cure. It's very hard to get diagnosed - it's typical to have to go to many doctors before you can get a diagnosis. Most patients (85%) remain undiagnosed. About the best that can be done is to rest aggressively and try to relieve the symptoms. 25% of patients are extremely disabled - homebound or bedridden.

It's very rare for anyone to have a full recovery. For some, "partial remission" occurs, but relapses frequently undo any improvement. This disease is basically a life sentence - people get sick young - as young as teenagers, and stay that way for the rest of their lives.

Hope

It doesn't have to be this way - for example, there are small trials of existing FDA approved drugs such as antivirals and immune modulators which are very helpful for some people. More research needs to be done as to which subsets can be helped by these drugs, and then get the drugs approved for use in this disease.

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What Can I Do to Help?

There are two things you can do to help. If you're in the United States, contact Congress using our convenient One Click app, telling Congress to officially recognize ME and fund it at $250 million per year. Or, make a donation to support our mission.

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  • Featured post

    Eileen Holderman CFSAC Public Comment About NIH Study

     

     

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    CFSAC

    Public Comment

    May 18, 2016

    Eileen Holderman

     

    Good afternoon to the Advisory Committee Members and to all stakeholders listening. 

    My name is Eileen Holderman - I'm an advocate for ME, GWI and other neuroimmune diseases. 

    Recently, I served as consultant to MEadvocacy, an organization advocating on behalf of nearly 1 million American men, women and children suffering from Myalgic Encephalomyelitis (ME). 

    Specifically, I collaborated on their blogpost titled, "NIH Sidesteps Critical Problems with the ME/CFS Study," which is a detailed analysis of the numerous problems with the study design and protocol and which offers solutions to those problems.  The organization has given their consent for me to talk about the blogpost. 

    The blogpost outlines many problems such as: multiple and ever-changing criteria - some which are deeply flawed, biased and/or inexperienced investigators and advisors such as Walitt, Gill, Saligan and Unger, additional problems with the study design such as a small cohort size, excluding patients who are most severely affected such as the homebound and bed bound, the use of Lyme Disease comparison groups which will cloud the results, the exclusion of the 2-day CPET testing for PENE, the refusal to release the specific budget for the study, the exclusion of ME experts when designing the study, and finally, the failure to set up a transparent, 2-way communication and participation process between NIH and the ME community (researchers, clinicians, advocates, patients, and caregivers) at every step of the way. 

    Obviously, with just 3 minutes allotted for public comment, I cannot address all the problems mentioned, but invite all of you to visit the web site MEadvocacy.org and click on the blogpost for a detailed analysis that proposes solutions. 

    Therefore, with the remaining time I have, I will focus on the critical issue of the study's criteria. 

    It is of utmost importance that the strictest criteria - the CCC or ICC - developed by our ME experts - not by the CDC or Government agencies - be used in studying ME, in order to ensure that investigators are looking at a homogeneous patient cohort. 

    The NIH Intramural ME/CFS Study has changed criteria 6 times.  First, NIH announced they would use the Reeves' criteria - which has been rejected by mainstream scientists and denounced by CFSAC.  After backlash from advocates, NIH announced the study would utilize the CCC, IOM, Fukuda and Reeves'.  After more protest from advocates, NIH then announced they would use multiple consensus criteria, including Canadian criteria.  Then Dr. Nath stated that NIH would use the Fukuda and CCC.  After the NIH Telebriefing, a new web site for the study showed one specific criteria to be used - the CCC.  Finally, Dr. Koroshetz, in his letter to MEadvocacy, stated that the CCC and IOM would be used for selecting patients for the NIH study. 

    For over 30 years, US Government health agencies have created erroneous definitions and names for this specific neuroimmune disease - Myalgic Encephalomyelitis - causing devastating harm to patients.  And other nations, like the UK, who created the flawed Oxford definition used in the PACE Trial, have done the same. 

    Our community needs NIH to step up and officially state that the Reeves' criteria and questionnaires will not be used in the NIH Intramural Study for ME/CFS; resolve the outstanding problems with the study design and protocol; and establish a transparent, 2-way communication and participation process with all ME experts

    Thank you.

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  • Featured post

    Why We Need May Awareness Day - Global Protest and More

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    Why We Need to Raise Awareness 

    Disease sufferers have different ways they try to raise awareness of their plight.  This is often done by distinct colored ribbons and assigned months when events and activities are geared toward raising awareness for that particular disease. 

    Myalgic encephalomyelitis (ME) uses the color blue for the awareness ribbon and the month of May has been assigned as the month of awareness.  All patients suffering from any illness have dire needs for attention, whether for funding for research or for proper care and treatment.  ME patients, because of the history of neglect and malfeasance by the government health agencies, have the added responsibility to testify about their personal stories and about the dismal history of medical abuse. 

    In order to be able to affect change, there is a need to explain why that change is needed. The Department of Health and Human Services (HHS) has been guilty in their actions and neglect of an estimated one million U.S. patients suffering for decades, without relief.  The Centers for Disease Control (CDC) is guilty of obscuring the reality of this neuroimmune disease by coining ME with the debasing moniker ‘chronic fatigue syndrome’ (CFS).  The government is guilty of willfully obscuring the disease by creating loose definitions that include patients suffering from idiopathic fatigue or psychiatric diseases.   

    The National Institutes of Health (NIH) is guilty of grossly underfunding ME for decades.  ME has been shown to have the lowest quality of life for its patients - lower than multiple sclerosis, congestive heart failure or cancer, yet NIH funding is at the bottom of the list of all diseases!  This malfeasance and abuse needs to be brought to light, shared widely and a great call for change needs to be shouted out. 

    It is only when change comes about in the form of restoring the proper historical name ‘myalgic encephalomyelitis’ and the adoption of the ME criteria created by ME experts like the Canadian Consensus Criteria (CCC) and the International Consensus Criteria (ICC), that progress with the disease will begin.  These two steps are needed as a prerequisite to any other actions toward progress.  We have witnessed and suffered from the damage caused by using the wrong name and criteria, such as marginalization, medical neglect, medical abuse and research on the wrong cohort of patients which confuse study results. 

    The NIH needs to start funding ME equally to other similarly burdened diseases.  This has been calculated as a minimum of $250 million a year for pure ME research funding.  More federal funding needs to be raised for other projects toward care, education and support for patients - equal to other diseases. (for example HIV/AIDS gets $16 billion discretionary funds on top of their $3 billion for NIH research).

    May 12 is Awareness Day for ME 

    MEadvocacy is a project of May12.org, whose mission is to “raise global awareness and education for Complex Immunological and Neurological Diseases (CIND)”.  The late patient and staunch advocate, Thomas (Tom) Hennessy Jr, was the founder of the May 12 International Day of Awareness movement. Tom said of the awareness day: “We would all agree to come together at least ONE day a year for May 12th to Lobby Congress and get the word out to the media that these CIND (Chronic Immunological and Neurological Diseases) were costing our economy tens of billions in lost productivity and billions in medical costs.” 

    May 12th was chosen to memorialize the birthdate of Florence Nightingale, the English army nurse who inspired the founding of the International Red Cross. Nightingale contracted a paralyzing CIND-like illness and became chronically ill. She spent the last 50 years of her life virtually bedridden, and despite being severely debilitated, she started the world’s first school of nursing. 

    Tom fiercely advocated for the name myalgic encephalomyelitis to be used for the disease and for the adoption of criteria created by our experts such as the Canadian Consensus Criteria (CCC).  He understood that it was the government-constructed demeaning name and faulty inclusive criteria that were holding the science back from real advancement, and stunted the much needed relief needed for ME patients worldwide. 

    MEadvocacy.org and May 12.org continue this legacy.  Our mission is to get the name, myalgic encephalomyelitis, recognized in the U.S. as it has appeared and been coded for decades at the World Health Organization (WHO). We are fighting for HHS to adopt ME criteria - the Canadian Consensus Criteria (CCC) or the International Consensus Criteria (ICC).  These are the first steps that are needed in order to reinstate the disease to its origins.  It is only with the basis of the rightful name and criteria along with NIH research funding equal to other similarly burdened diseases ($250 million a year), that we have the possibility to solve this disease and bring hope to the millions of sufferers. 

    May Events and Activities 

    • Use a Profile Overlay: Change your social media profile page with a May awareness overlay. See the easy instructions here.

    • Write to Congress: Send an easy one click letter to Congress asking them to direct HHS to: Use the historic name myalgic encephalomyelitis which conforms with the World Health Organization (WHO); adopt criteria created by the medical experts - the Canadian Consensus Criteria (CCC) or the International Consensus Criteria (ICC); fund NIH research commensurate with other similarly burdened diseases - $250 million per year.

    • Demonstrate: A #MillionsMissing protest will take place on May 25, 2016 in Washington DC at the Department of Health and Human Services (HHS). There will be simultaneous protests nationwide at HHS regional offices in Atlanta, Boston, Dallas, San Francisco and Seattle, and worldwide protests in Vancouver, Canada, London, England and Australia.  See this link for details and for instructions on how you can participate at the actual or virtual demonstrations.

    • Send Awareness to Congress: Purchase a copy of the documentary Forgotten Plague’ and give instructions so that it can be mailed to your Congressional representative.  See here.

    • Map the Disease: Place yourself on the disease map for ME and CFS to show graphically how many of us there are. Patients, their family members or friends and organizations can take part in this here.

    • Light Up the Night: USA May 12 MECFS Awareness Day Light Up the Night Campaign

              https://www.facebook.com/events/1514264558796071/

              https://www.youtube.com/watch?v=O4Bzevj6WGA&feature=youtu.be

              https://www.facebook.com/USALightUptheNightMay12/

    • Walk for Awareness: ME/CFS Awareness Walk 2016 - Troy, Michigan (Detroit area), organized by new organization FIND (Foundation for Immunological and Neurological Diseases) contact Frank Plizga at sicnar@comcast.net - https://goo.gl/EJsiW3. The walk is from noon to 1 pm. So far they have 5 confirmed walkers and 5 conditional. There will be balloons, signs and passouts.

    • Blog for Awareness: #May12BlogBomb started and hosted by Sally Burch is an opportunity for anyone to blog and raise awareness about one of the chronic illnesses that Share May 12 Awareness day.  See instructions about how to send in a submission here.

    • Sign the Dutch Petition: Add your signature to ‘ME is not MUPS’ (medically unexplained physical symptoms)to tell the Dutch Health Council to replace the committee members who believe that ME is a functional and somatoform illness -  here.

     Links: 

    May12.org (US organization) - Awareness events -  http://may12.org/

    Link to May12th.org (Canadian organization) 2016 events document:

    https://docs.google.com/document/d/1ccLiDiapINpmeTNWfZw-ajuGjVcuY0XWYt2VdtPD8iE/edit

    Link to Prohealth article for other May awareness activities:

    http://www.prohealth.com/ME-CFS/library/showArticle.cfm?libid=28862

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  • Featured post

    Easy Way to Create May Awareness

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    May Awareness

    May is awareness month for the related complex immunologic and neurologic diseases (CIND):  

    ME, CFS, Lyme, GWI, FM and MCS. 

    May 12 is the specific date chosen to raise awareness for these diseases, because it’s Florence Nightingale’s birthday. After her groundbreaking work in nursing, Nightingale became bedridden for decades from a mysterious disease similar to ME. 

    This year, May12.org has developed an easy way to spread awareness across social media with a May awareness overlay for your Facebook, Twitter or other social media profile photo.

    Disease Choices

    You have a choice of 8 graphics:

    • Myalgic Encephalomyelitis
    • ME & CFS
    • Lyme Disease
    • Multiple Chemical Sensitivity
    • Chronic Lyme Disease
    • Fibromyalgia
    • Gulf War Illness
    • Act Up 4 ME 

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    Instructions

    To create your overlay, simply go to the easy overlay generator page and follow the instructions http://arlenburroughs.com/extras/may12overlay/make_overlay.php 

    There are four easy steps -

    1. upload your profile photo or use your Facebook profile picture*

    2. Select the overlay you desire

    3. Download the result to your computer

    4. Upload the result to any platform where you want to raise awareness 

    When you’ve completed uploading your profile, drop us a line at our MEadvocacy.org Facebook page or Twitter @MEadvocacy_org or @May12org page to test it out!

    Everyone is welcome to use the awareness graphics on this page. Photos can be downloaded to your computer by right clicking on image and saving to your computer.

    Thank You 

    Thanks to Arlen Burroughs for volunteering to code and host this for everyone to use! 

    *Note:  Awaiting approval from Facebook for permission to upload the photo directly to Facebook.  In the meantime you can download the finished filter picture and upload to any platform.

     

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  • Featured post

    Dutch ME-Community Appeals for Global Help: Sign Petition

    Guest Blog submitted by  the ME Global Chronicle staff
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    MUPS (Medically Unexplained Physical Symptoms)

    This is a guest post by ME Global Chronicle, a bi-monthly international online magazine, covering news on myalgic encephalomyelitis from all over the world.  They are currently featuring a petition to the Dutch Health Council calling for the replacement of panel members to a government advisory committee who have a psychogenic bias of the disease.

     

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  • Featured post

    NIH Sidesteps Critical Problems with the ME/CFS Study

    MEadvocacy would like to thank advocate Eileen Holderman for her consultation on this blog post.

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    MEadvocacy sent a petition to NIH to cancel and restart the NIH Intramural Study on ME/CFS because of the many significant problems with the study’s design and protocol and lack of myalgic encephalomyelitis (ME) stakeholders’ input. 

    Since then, NIH has used various and confusing ways to communicate new and changing information about the study.  As further information became available, we voiced our deep concerns about many of the significant issues with the study: multiple and ever-changing criteria, some of which are deeply flawed; biased and/or inexperienced investigators and advisors; additional problems with the study’s design; mistrust of the government health agencies and the problems with the way NIH is communicating. 

    This is a unique opportunity to design a robust study using the comprehensive resources of the NIH Clinical Center.  It is crucial that this study be done with ME experts' and stakeholders' input from start to finish. This will ensure meaningful results and scientific advancement for patients who suffer from this serious, disabling disease. 

    Petition Summary

    The MEadvocacy petition with 725 signatures was initiated on February 9, 2016, and sent to Dr. Francis Collins, Director of the National Institutes of Health (NIH), on February 15, 2016.

    The petition called for: 

    • Rejection of the Reeves’ criteria and its associated questionnaires

    • Restart of the NIH clinical study using a protocol pre-approved by ME experts and stakeholders

    • Transparent communication to the patient community

    • Use of ME criteria created by our experts to select a more homogeneous ME patient cohort such as the International Consensus Criteria (ICC) or the Canadian Consensus Criteria (CCC)

    On February 23rd, we sent a follow-up reminder with additional concerns about the study:

    • NIH chose a lead associate investigator, Dr. Brian Walitt, with a psychosomatic viewpoint of the disease

    • The selection of recovered Lyme disease patient group (a disease fraught with controversy) as a comparison cohort

    • The selection of functional movement disorder patient group (a disorder that falls under the mental illness classification of somatoform disorders) as a comparison cohort

    At the March 8th NIH Telebriefing, we asked a question as to when we would receive a response to the petition. 

    On March 11th, MEadvocacy received a reply to our petition from Dr. Koroshetz. However, Dr. Koroshetz’s reply and NIH/NINDS’ actions sidestepped our crucial concerns. 

    The Ever-Changing Criteria 

     

    Why is Research and Clinical Criteria Used for Patient Selection So Important in ME? 

    Many diseases have testable biomarkers for use in selection of patient cohorts in studies. This ensures that the correct group of patients are being looked at. This is not the case with ME. To date, a testable biomarker has not yet been accepted.  Therefore, it is of utmost importance that the strictest criteria (ICC or CCC) be used in studying ME in order to ensure that investigators are looking at a homogeneous patient cohort. 

    Historically, the criteria issue has been a grave problem with research into ME because various vague criteria have been created and used. Overly broad CDC criteria, such as Reeves and Fukuda, include patients who have: chronic fatigue, idiopathic fatigue, somatoform disorders, major depressive disorders, and other unrelated conditions. CDC has created the problem of heterogeneity of the disease and caused the commingling of cohorts.  For three decades, they have served to obscure the original findings of ME outbreaks which has led to the suffering of a million American men, women and children. 

    Timeline of Criteria Changes  

    From the time NIH posted the first protocol showing the Reeves’ criteria on their website, it has been a fiasco of continually changing criteria and news. 

    • First, the initial protocol posted on the NIH website became public with what we were later told was incomplete information. This protocol showed that Reeves’ criteria would be used to select the patient cohort.  Furthermore, the NIH website code reveals that changes had been made to the protocol at least two times, which makes it hard to believe that it was ‘mistakenly posted’ in order to achieve a study number, as stated by NIH (see details here).

    • Days later, the initial protocol was removed and NIH did not post a reason why it was removed. 

    • Later that day, an advocate posted a notice on a website stating that NIH informed them of the following: “Enrollees will meet all definitions for ME/CFS, including Canadian Consensus Criteria, IOM, Fukuda and Reeves, in addition to post-infectious onset.” 

    • A week later (about an hour after MEadvocacy’s petition was delivered to NIH), Dr. Koroshetz sent an email to a select few advocates, stating that patients will: “...qualify under multiple consensus criteria including the Canadian criteria. Reeves was being used only for stratification purposes.” 

    • The next day (after Koroshetz sent his email), Dr. Nath informed the public during his CDC Grand Rounds presentation that the NIH study would use two criteria - Fukuda and CCC - for selection of patients (see slide #53 here). 

    • Three weeks later, at the NIH Telebriefing, none of the four NIH presenters mentioned criteria.  However, it was announced that a new website for the study went up that morning which shows one specific criteria to be used - the CCC (item #1 on FAQ page).

    • The most recent letter to MEadvocacy by Dr. Koroshetz now states that two criteria - the CCC and IOM will be used for selecting patients (3rd paragraph). 

    The Need for Real ME Experts in the Study 

    In his March 11th letter to MEadvocacy, Dr. Koroshetz states: “As you may know, the NIH study protocol is still being revised.  It is being developed with guidance by experts from a number of disciplines and is intended to be the most detailed physiological analysis to date of patients who developed ME/CFS following an infection.” 

    Dr. Koroshetz sidesteps our request for ME experts and patient advocate involvement with the study design and protocol from the beginning. He responds with the information that experts from a number of different disciplines were involved in the guidance, but doesn’t state that they were experts specifically in ME. 

    If ME advocates would have been involved from the beginning and given power of approval, Drs. Brian Walitt, Fred Gill and Leorey Saligan would not have been put in charge of assessing diagnostic validity for selecting and managing patients in the clinic. 

    The Inherent Bias of the Lead Associate Investigator and Those in Charge of Patient Selection 

    The FAQ section of the NIH study website states the following:Most patients will be recruited from well-established ME/CFS clinics that are being supported by the CDC in the Multi-site Clinical Assessment of CFS study. 

    It says “most” but not all. This is very troubling because we don’t know what they mean by “most”. For instance, does it mean 25 patients will come from the ME/CFS clinics and 15 will not? Where will those not coming from the ME/CFS clinics come from? Furthermore, the website instructions state that one can register online to become a participant in the study. Where are those patients coming from? 

    The final assessment will be done by “clinical experts at NIH, including Drs. Fred Gill, Leorey Saligan, and Brian Walitt” who have inherent and common biases about the disease. We do not believe the selection of these specific NIH researchers, who have the same inherent bias, is a coincidence, but rather an indication of the path this study was intended to take. 

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    NIH Intramural Study on ME/CFS website -  FAQ section

    Dr. Brian Walitt has been selected by NIH as lead associate investigator for the study, as well as part of the committee selecting the patient volunteers. Much has already been written about the concerns of having a lead associate investigator who believes fibromyalgia and chronic fatigue syndrome (CFS) are psychosomatic and somatoform disorders. In September 2015, Dr. Walitt gave an interview at a rheumatology conference on fibromyalgia which advocate Jeannette Burmeister blogged about.  It is troubling that Dr. Walitt will be responsible for administering the subjective questions/questionnaires by phone and in person at the clinic. 

    Below are just a few studies Walitt has been involved with:

    Dr. Fred Gill worked with the late Stephen Straus, NIH virologist who ignored the biological evidence of ME in favor of a psychological view which set the tone for decades to come, as noted by advocate Dr. Mary Schweitzer in her blog.  In a letter (part 1 and part 2) Dr. Straus wrote to Dr. Fukuda, he laid out his plan to “evaporate CFS”; see advocate Craig Maupins blog, The CFS Report. 

    In February 2011, Dr. Gill presented at NIH (presentation video here at the 54:17 minute mark) he said: Dr. Straus who was much younger than me and not with us anymore but my mentor in EBV and Chronic Fatigue finally wrote a paper near the end in 2004 about pharmacotherapy. All the things I just showed you. And I agree with what he said to this day that many therapies have been tried but so far only cognitive behavioral therapy and graded exercise appear to be meaningful, to produce meaningful benefit.” 

    Advocate Charlotte von Salis attended the presentation and blogged about it here. What follows is an excerpt from her blog: “Gill’s big on reassuring the patient, avoiding unnecessary tests, avoiding debate over whether it’s psychological, and above all, getting patients to remain active and exercise no matter what.” 

    Dr. Leorey Saligan is a family nurse practitioner/investigator who researches biobehavioral mechanisms of fatigue. He states that the reason that CFS patients report pain and fatigue is because they seek attention and are catastrophizers. 

    Below are just a few studies Saligan has been involved in: 

    Ways to Correct Problems with the Criteria and Investigators

    • Use a single criteria for the study - the ICC or the CCC.

    • Declare officially that NIH will not use the Reeves’ criteria and questionnaires (see references 11, 13 and 14) for any purpose in the study (see here for concerns about Reeves’ questionnaires). Replacement questionnaires (aka ‘instruments’ per clinical investigators) must be approved by ME experts and stakeholders.

    • Remove Walitt, Gill, and Saligan from the study and replace them with individuals with knowledge of ME as a biomedical disease who currently and historically do not ascribe to the psychosocial or psychosomatic causation of symptoms.

    Problems With Executive Committee Advisors Who Are Not Experts In ME 

    Dr. Elizabeth Unger, CDC virologist, focused many of her studies and presentations on fatigue and the mind/body theory as she explained in this CFSAC video clip (posted by advocate Khaly Castle). As co-author of the Reeves' criteria, Dr. Unger explained in this video how her agency applies the criteria when asked by Eileen Holderman, former CFSAC Member, how CDC plans to reconcile the case definition issue.  In the NIH study, Dr. Unger has been assigned to the executive committee and charged with reviewing diagnostic validity of the patient cohort.  At the February 16th CDC Grand Rounds, Unger promoted graded exercise therapy (GET) and cognitive behavioral therapy (CBT), which is also promoted by the PACE Trial, for which ME experts have warned against as causing harm to patients. 

    Below are just a few studies Unger has been involved in: 

    Dr. W. Ian Lipkin is a world renowned virologist. In recent years, Dr. Lipkin has been investigating ME/CFS and collaborating with ME experts. Dr. Lipkin serves as an advisor on the study and will approve patient cohort selections. While Lipkin’s research shows great promise, he is not an expert in diagnosing and treating ME patients. 

    Ways to Correct the Problem with Advisors Without ME Expertise

    • NIH should seek advisors to the executive committee that have extensive experience investigating, diagnosing, and treating ME patients.

    • Advisors need to be approved by ME stakeholders.

    Additional Problems with the Study’s Design 

    • The cohort size of 40 ME patients is too small. 

    • The study excludes patients who are the most severely affected such as the homebound and bedbound. 

    • The use of recovered Lyme disease comparison control groups will obfuscate the results. 

    • The summary of the study states they will conduct a bike exercise test twice, but does not specifically state the consecutive two-day CPET testing for post-exertional neuroimmune exhaustion. 

    • The specific budget for this study has not been released and published.

    Ways to Correct  Problems with the Study’s Design 

    • Increase the ME/CFS patient cohort size to increase probability of producing meaningful statistical results. 

    • Include homebound and bedbound patients in the study. Historically, these patients have been under-researched and have the greatest potential to yield strong biomedical abnormalities. 

    • Remove the asymptomatic recovered Lyme disease comparison control group from the study because they are prone to developing chronic Lyme disease (refer to here and here). In addition, the 2-tier testing used by the CDC for Lyme disease is not accurate. ME and chronic Lyme disease have overlapping symptoms and many ME patients are undiagnosed chronic Lyme disease patients due to a high level of false negative CDC test results. Therefore, this would obfuscate the comparison of these two disease groups. 

    • Incorporate the consecutive two-day cardiopulmonary exercise testing (CPET) protocol into the study. The current bike exercise test, mentioned in the study summary, does not confirm whether post-exertional neuroimmune exhaustion occurs by documenting reduced VO2max on the second day. 

    • Release and publish all budget information regarding funding for the study from its inception to conclusion. 

    Mistrust of Government Health Agencies and Problems with the Way NIH Communicates 

    The government health agencies have a history of malfeasance with this disease as documented by journalist and advocate Hillary Johnson in her book Osler’s Web. In 1985, the CDC went to Lake Tahoe, Nevada to investigate an ME outbreak and dismissed what they saw. They renamed the disease with a trivial moniker, chronic fatigue syndrome (CFS), and created a vague definition - both of which have caused serious harm to patients. 

    Additional abuses to the ME community include: CDC diversion of $12.9 million earmarked for ME/CFS research to other diseases; NIH underfunding biomedical research; Chronic Fatigue Syndrome Advisory Committee (CFSAC) FACA violations; HHS threats of eviction made to three CFSAC members; NIH/HHS FOIA violations and unreasonable conduct during the trial of FOIA violations (refer to Jeannette Burmeister’s blog on violations); and HHS dissemination of erroneous information about the disease to medical professionals, the media, and the public.

    As illustrated, the patient community is justified in their mistrust of the government health agencies. Therefore, the burden is on the health agencies to rebuild the lost trust. NIH’s miscommunications are contributing to the mistrust. 

    Problems with the Way NIH is Communicating 

    • Communicating information and conducting private meetings to only a select few advocates instead of the entire ME community.   

    • Conveying conflicting information (by various agencies) about the study by various websites, presentations, and communications.

    • Sidestepping advocates’ questions and concerns (see examples below). 

    • In his reply to advocate Joni Comstock’s question during the NIH Telebriefing, Dr. Walter Koroshetz stated: ...our intent is to reach out and get input from a wide variety of folks with expertise and with experience in this illness. And we have been doing that right from the beginning at NIH through the Trans-NIH Working Group, through the CFS Advisory Committee. We’ve had multiple meetings with experts in the field and with advocacy groups. And I must say it has been a challenge for us because there are, well we may not have reached out to everybody.”

    Does “experts in the field” mean ME experts?  NIH has not officially notified the community about specific ME researchers, clinicians or advocates who have been advising about the design of the study. There have been no assurances that ME experts and their input would be part of the study’s design and approval process.

    • Dr. Koroshetz further states:And so, I think that the major teachers at the NIH really have to be the patients who have made the sacrifice to join the protocol, to come into the Clinical Center and to work with the doctors.”

    By the time patient volunteers are involved, the design and protocol for phase 1 will have been set. Clearly, ME experts’ and stakeholders’ input and approval will not be be considered. 

    • At The CDC Grand Rounds (You Tube video minute mark 53:23), Dr. Nath stated: “So, careful listening to patients is absolutely critical. So, with that in mind, you know I grew up in the early AIDS epidemic, and I saw interactive with Act Up, and other patient forums whereby they had a great impact on the way disease was handled, treated and moved the Federal government to make changes at every level. And so, we understand the importance of it, and there are efforts under way to put that advisory group together.

    Yet, at the NIH telebriefing, Dr. Nath stated: “So we looked into some of the legalities about patient advisory groups and it’s a little bit complicated in the federal government.” This implies that the assurance made by Dr. Nath at the CDC Grand Rounds regarding creation of a patient advisory group to provide input on the study may not occur because NIH does not want to deal with looking into an important but possibly complicated matter. 

    On one hand, NIH is telling the community they want patient and advocate input but on the other hand, NIH is implying that patients should just stick to telling them about their symptoms rather than advise them about the design of the study. 

    Ways to Correct the Problems with the Way NIH is Communicating

    • Reinstate the original protocol on http://clinicalstudies.info.nih.gov/ and clinicaltrials.gov, showing the changes that have been made. Also, remove the now inaccurate Trans-NIH Research ME/CFS Working Group “Eligibility Requirements for ME/CFS Clinical Study at the NIH” orphan webpage that still references functional movement disorder as a cohort.  Release the history of the protocol to the public including protocol details and the Institutional Review Board (IRB) approval dates so that appropriate ME stakeholder input can be provided. 

    • Communicate all information in real time to the entire community by using an NIH ME/CFS listserv.

    • Coordinate information across various agencies and sources so that all messaging is consistent.

    • Initiate and maintain a transparent and two-way communication process between NIH and the ME community (researchers, clinicians, advocates and patients) at every step of the study.

    NIH Needs to Step Up! 

    For over 30 years, NIH and CDC have had a history of institutional bias, malfeasance and medical abuse toward the ME community. They have accomplished this by creating a trivial name and erroneous criteria, underfunding, and the promoting of harmful treatments such as GET and CBT. The Department of Health and Human Services (HHS) has ignored our ME experts’ biomedical evidence of abnormalities in the neuro-endocrine-immune systems of patients with ME - and instead used their own psychosocial and psychosomatic theories to describe a serious neuroimmune disease. 

    HHS needs to make concrete changes in order to affect real change in how ME is perceived and studied. Although NIH deems this study as only one piece of the puzzle, the Department has a record of turning that puzzle piece into a cornerstone of research dogma for decades to come.

    Because of the opportunity for great discovery using the comprehensive resources that the NIH clinic has to offer, it is this very reason, we call for NIH to restart the study and include ME experts’ and stakeholders’ input throughout the entire process. The NIH study needs to use one criteria (the ICC or CCC), remove investigators and advisors without ME/CFS expertise and/or who possess a psychological bias (such as Drs. Walitt, Gill, Saligan, and Unger), eliminate comparison groups that will obscure study results, and communicate transparently to the entire ME community. 

    Now is the time for NIH to stop sidestepping the critical concerns ME stakeholders have about the study and step up to make the changes called for! 

    *Please note: MEadvocacy uses the term myalgic encephalomyelitis [ME] to describe the disease defined in the ICC or CCC. When we use the term ME/CFS or chronic fatigue syndrome [CFS], we are using the terminology due to the specific context in the blog. For information see www.MEadvocacy.org.

    For Further Facts About ME, see MEadvocacy’s

    Simple ME Fact Sheet

    Brief History of ME

    ME Science Links

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  • Featured post

    NIH Telebriefing Presentations and Protocol in a Nutshell

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    MEadvocacy attended the National Institutes of Health [NIH] telebriefing on March 8th, 2016.  

    We issued a blog on March 9th with the question that we posted to NIH and the reply we received.

    In this blog, we are giving the highlights of several presentations from NIH and National Institute of Neurological Disorders and Stroke [NINDS] regarding intramural and extramural NIH research.  Many questions and concerns still remain, with some additional new ones. We will follow up with a blog with commentary on the call and the new protocol posted on the NIH website.

    The NIH telebriefing audio file, released to us, is now available here.

    [Photo of National Institutes of Health Clinical Center]

    NIH Presentations


    Summary of opening remark by NIH director, Dr. Francis Collins

    Dr. Collins personally welcomed us to what he hoped will be an ongoing conversation about ME/CFS research. “...and how we can move the needle forward together when characterizing the cause of this perplexing disorder to help with better diagnosis and treatment.”

    He stressed that the institute and director are very committed to move the science forward; with the intramural activities as well as extramural programs.

    Highlights:

    • The intramural study protocol received institutional review board (IRB) approval.

    • They will begin enrolling patients this summer.

    • The website with detailed information on intramural protocol went up March 8th (link).

    • It’s a remarkable opportunity to use world class NIH clinic and their interdisciplinary hospital.

    • There’s heterogeneity in this condition.

    • Focus is on sudden onset with flu like illness in order to limit heterogeneity.

    • Trans-NIH ME/CFS Working Group [TNWG] is planning to define strategic areas of research that could form the basis for short and long term extramural applications.

    • Looking to recruit new eyes/brains/investigators to the field to solve the puzzles.

    Dr. Collins reaffirmed his commitment and asked patients to stay the course.  He knows many patients have waited a long time.  He concluded by saying that we should work together not apart. He said NIH is listening carefully to patients’ and advocates’ comments and suggestions.

    Summary of presentation by NINDS director, Dr. Walter Koroshetz

    He thanked everyone for expressing their interests and concerns.  He is very interested in working together toward a long term common goal.  

    Highlights:

    • This is a difficult problem or else it would have been solved long ago.

    • They need to bring in the best and the brightest from many areas of science.

    • They need expert clinicians and researchers.

    • NIH has an extramural program where funds go to universities and other institutions to do research.

    • The intramural program is when research is done at the NIH clinic in Bethesda, Maryland which is largest research hospital in the world.

    • 90% of the NIH’s funds go to the extramural branch.

    • The Trans-NIH ME/CFS Working Group [TNWG] brings scientists and funding together from many institutes. This is important because we don’t know where the solution will come from.

    • The TNWG is devising plans to move funds to highly meritorious extramural research proposals.

    Summary of presentation by a program director at NINDS , Dr. Vicky Whittemore

    Thanked us for being on call.  She has been working with Dr. Koroshetz to coordinate the TNWG.

    She works with representatives from the staff of the 23 NIH institutes and centers who are passionate and dedicated about this work.

    Highlights:

    • They are in the process of putting together both short term and long term plans.

    • The priorities are to find biomarkers, causes and mechanisms that lead to ME/CFS.

    • They want to understand what is causing ME/CFS brainfog and cognitive symptoms.

    • They are working very hard to present initiatives to the appropriate councils for approval, in the May timeframe.

    They are looking forward to input and feedback from ME/CFS community.  Some of the ways are to put out specific requests for feedback on different ideas they have, with follow-up conference calls, as well as getting feedback from the research and clinical community.

    Koroshetz added a note to clarify:  ”...people are wondering out there, ‘Why can’t we actually say what we are thinking?’"  But, NIH has processes that ensure the research that comes in and the most meritorious research is funded and that all groups have a fair hearing. Therefore, NIH cannot divulge information until they can make it public to everyone.

    Summary of presentation by primary investigator, Dr. Avindra Nath

    Dr. Nath stated that he was delighted to be asked by Dr. Collins and Dr. Koroshetz to be the principal investigator of this intramural study. 

    He was thrilled to be able to look at the syndrome and see if there is an immune or neuroimmune component here that maybe driving the disease. This is the area of his expertise. He has seen patients and knows how devastating it can be.

    Highlights:

    The literature indicates it is likely immune mediated, and the protocol he designed addresses these issues.
    There are three phases to the study:

    1. cross sectional study - a lot of investigation on a small group of patients

    2. longitudinal study - larger group of different patient population for a longer period of time with a repeat of subset testing

    3. Intervention study - based on first two phases will bring guidance as to what type of immune modulating therapy could work.

    Summary of presentation by lead associate investigator, Dr. Brian Walitt

    He is lead associate investigator for intramural protocol at NIH.  His experience starts with a career in rheumatology.

    Highlights

    • Has experience in hospital immune disorders with specialty in ME/CFS and fibromyalgia.

    • Opened research clinic in Georgetown University to study these disorders.

    • Patients taught him how real these disorders are. “they are not just in one’s head”. They do not reflect some unconscious choice. It’s not possible to simply push through the symptoms.

    • Try to help patients but learned how limited the options really are

    • There is an urgent need for restorative treatments to give patients their lives back.

    • Learned a lot from the world class scientists at the NIH clinic.

    • Wants to find answers to the big questions of ME/CFS: the role of infection, immunology and neurology in the degeneration and perpetuation of symptoms.

    • Wants to find and understand the biology of post exertional malaise.

    More from Dr. Koroshetz

    He wanted to emphasize that 26 associate investigators will be working along with Drs. Nath and Walitt, who will bring their expertise to the table.  This includes high level neuroimaging and high level ability to look at cytokines and autoantibodies. They also have Leo Saligan from the nursing institute who has been looking at chronic fatigue in patients with cancer and rheumatological disorders.

    The NIH clinic has full time devoted researchers with many resources available to them like the capability to bring patients into study for days or weeks. This study is just a stepping stone - one piece of the puzzle but an important one to coordinate with other initiatives across the country.

    The presentations were followed by a Q & A session from the audience listening in on the call.  You can listen to the questions and replies on the audio file.  The Q & A section starts at 20:00 minutes. 


    Some highlights from the protocol listed on new NIH website

    This is the first phase of the research project.  It will take place at the NIH clinic in Bethesda, Maryland.

    Criteria:

    • The Canadian Consensus Criteria (CCC) will be used for all ME/CFS patients.

    • They will all be objectively tested for post exertional malaise (PEM).

    • They will be screened with validated functional scales to measure severity.

    Other Characteristics for selection:

    They are selecting sudden-onset post-infectious ME/CFS patients who have been sick between 6 months to 5 years.

    Selection Review:

    Most patients will be recruited from well-established ME/CFS clinics that are being supported by the CDC in the Multi-site Clinical Assessment of CFS study.

    In addition, the following experts on the executive committee will review the selection of patients:

    A final assessment of diagnostic validity will be performed by a team of clinical experts at NIH, including:

    Control Groups:

    They will start with a healthy control group and a recovered post-lyme group.  They are discussing the addition of other control groups.

    Why the choice of post-Lyme patients?  Since they are focusing on the post-infectious ME/CFS cohorts, they think it would be useful to compare them against a cohort that also had an infection but then fully recovered.  (Many Lyme patients already have been evaluated at the NIH.)

    Start of Patient Selection:

    They anticipate enrolling patients starting summer of 2016.

    Screening Procedures Will Include: (should last 2 to 3 days)

    • Initial phone screening.

    • In-person screening visit.

    • One-week inpatient stay at the NIH Clinical Center.

    Brief Description of Procedures:

    Initially

    • Completion of a telephone screening with the study staff.

    • An explanation of the study and signing of the research study consent form.

    • Medical history.

    • Physical exam.

    • Blood and urine collection.

    • Questions about the participant’s life and their quality of life.

    • Questions about the participant’s mental health.

    Follow Up

    • Magnetic resonance imaging (MRI). Participants will lie in a machine that takes pictures of their brain. They may get a dye through an intravenous (IV) line that is placed in their arm. (A thin plastic tube inserted into a vein).

    • Hand grip strength test.

    • Saliva test for virus testing.

    • Tests of body functions such as sweating and breathing, blood pressure while standing upright, sitting and lying, and heart rate.

    • Collection of blood cells. Participants can choose to have the blood drawn through the IV or through a machine that filters blood cells and returns the liquid blood back into the participants' vein.

    • An explanation on how to wear an activity monitor and complete a fatigue diary. Participants will use these tools to record their activity and fatigue symptoms for at least one week, once they are back at home.

    • Review of medications. Participants may be asked to taper off certain medicines that affect the brain and nerves.

    Selected patients will go home and taper off medications, they will also use an activity monitor and a fatigue diary. Within 6 months of first visit, the participants will return for a one week inpatient hospital visit.

    During inpatient visit, participants will perform a stationary bike exercise test twice. The purpose of the exercise test is to make participants tired and to try to evoke symptoms, such as 'post-exertional malaise'. Tests will be performed before and after exercise testing.

    Tests Will Include:

    • Questions about how participants are feeling.

    • Samples of saliva, stool, and a cheek swab to test stress hormones and the types of bacteria living in the mouth and gut.

    • Thinking and memory tests.

    • Overnight heart monitoring.

    • Transcranial magnetic stimulation. A brief magnetic pulse from a magnet held over the scalp can affect brain activity and will be used to examine what brain excitability changes occur with muscle fatigue.

    • Imaging studies such as an X-ray and magnetic resonance imaging (MRI). During an MRI participants will lie in a machine that takes pictures of their brain. They will do thinking and exercise tasks during the MRI to examine what changes in brain activity occur with different types of fatigue.

    • Lumbar puncture. Fluid will be removed by placement of a needle between the back bones.

    Note:  In reply to a question posed by Charmian Proskauer about the small size of patient cohort (40), Dr. Nath replied that only one patient will be studied for a week at a time.  It will take at least 40 weeks just to study the ME/CFS cohort group.

     

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  • Featured post

    NIH Obliquely Dismissed 725 Voices While Stating that Patients' Input Matters

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    MEadvocacy’s Question and Reply at the NIH Telebriefing, March 8, 2016

    MEadvocacy took part in the 10:00 am EST teleconference today from the NIH, which included a capacity of 100 listeners.  There was an initial introduction by NIH director Dr. Francis Collins, followed by presentations from NINDS director Dr. Walter Koroshetz, NINDS program director Dr. Vicky Whittemore, primary investigator Dr. Avindra Nath and lead investigator Dr. Brian Walitt.

    The presentations were followed by a Q&A period. Advocates had the opportunity to submit questions that were addressed by the panel, if chosen during the allotted time period.

    MEadvocacy will elaborate on the full briefing at a later date.  For this blog, we are submitting the question that we posed to the NIH followed with their reply.

     


    MEadvocacy’s Question

    Announcer:  Our next question comes from Joni Comstock, your line is open.

    Joni Comstock: Hi, I represent MEadvocacy, a grassroots, non-profit organization advocating for patients suffering from ME.

    Our focus is the severely affected patients, most of whom are homebound and bedbound. Some are so sick they are unable to care for themselves.

    We were dismayed to learn that the protocol and design for the intramural study has been well underway without any input from the ME/CFS expert clinicians, researchers, as well as from the patient and advocate community.

    This became even more disturbing as so many flaws were revealed about the study. These deficits showed us that many of the ingrained agency misconceptions of the disease still exist and have not been clarified. Therefore, we initiated and delivered a petition with 725 signatures to Dr. Collins, to stop the study and start it from scratch with stakeholders input from the get go.

    Because of ingrained institutional misconceptions, whether deliberate or not, we expect the NIH to engage the expert community on any ME/CFS study from the moment of its inception.

    They should have input throughout the entire process.

    This includes: the planning and implementation of the design, recruitment, trial, analysis, study outcome, peer review publication, and the publicity.

    Do you intend to respond directly to MEadvocacy about the petition and how do you plan to incorporate our concerns?

    Reply from Dr. Koroshetz and Dr. Walitts at NIH

    Koroshetz: Let me just start at ah ..I appreciate your concerns. And ah...Our intent is to reach out and get input from a wide variety of folks with expertise and with experience in this illness.

    And we have been doing that right from the beginning at NIH through the trans NIH working group, through CFS advisory committee.

    We have had multiple meetings with experts in the field and with advocacy groups.

    And, I must say it has been a challenge for us, because there are...we may not have reached out to everybody and we apologize for that.  

    It has been very been difficult to know exactly who everybody is and that’s the reason we have these calls and this is not going to be the last of our calls. But, it’s only the beginning. And, we will learn from patients.

    I think the history of medicine is, that as you work with patients, the patients teach you lessons.

    So I think the major teachers at the NIH really have to be the patients who have made the sacrifice to join the protocol, to come in to the clinical center and to work with the doctors.

    I think that’s where a lot of the input is going to come.

    The protocol itself, Brian can correct me if I’m wrong, but the protocol is always a work in progress. So, the protocol gets put up, it has to get approved, then it moves forward. Then there are amendments, then they have to get approved again, then it moves forward so and the protocol is something that is gonna have to be tested.

    We will be probably bringing in control persons to see if they can manage the protocol as it stands before we bring in patients with ME/CFS and put them through the protocol as it stands.

    So, so I think we are definitely interested in getting input.

    But the truth of the matter is that scientists at the NIH have.. they have to be the ones who have to be empowered to work with their patients to try to get at the bottom of these..what is the biologic nature of ME/CFS.

    So, we are very interested to move ahead.  

    And we can’t, you know, take all patients with ME/CFS. The very severe cases, who are homebound, I think would certainly not be wise to start there.

    Um ..Brian do you have any points on that?

    Walitt: Part of the protocol is to look at post exertional malaise which requires pushing patients a bit, being able to exercise, being able to do things. 

    Taking a homebound population and stressing them more… may lead to untoward consequences for patients and we need to be concerned about those things. It’s definitely a very important population to study, but that might be for the next phase.

    Koroshetz: And I think the clinical Center does have the ability to bring people into the hospital who are in, in very poor condition. Because it is a hospital, it has 24 hour nursing. So it is something that we could potentially get to it at some point. But I think it would be probably unwise to start there.

    So again, I apologize to the community for the perception that we are not listening, because we are very much listening. And, we will continue to listen and we will continue to communicate the best we can, so thank you very much for that.


    REFERENCES:

    Summary of NIH Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Research Study:
    http://mecfs.ctss.nih.gov/index.html

    MEadvocacy petition to Dr. Collins with 725 signatures:
    https://www.dropbox.com/s/9ivx8iu8z3rhzgd/stop_nih_study_petition_final_2-15-16.pdf?dl=0

    Trans-NIH ME/CFS Working Group:
    http://www.nih.gov/research-training/medical-research-initiatives/mecfs

    CDC Multi-Site Clinical Assessment of CFS:
    http://www.cdc.gov/cfs/programs/clinical-assessment/

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  • Featured post

    How Activism Empowers Progress

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    Lately, we have noticed a disturbing trend. Various members of the ME community  have been chastising vocal activists/advocates for being too militant, because they’re afraid that somehow this anger will be used against them, or they just find anger distasteful in general.

    The majority of advocates are women. Traditionally, women are socialized to be polite, submissive, and not rock the boat. This leads us to believe that there may be different cultural and social perspectives at play.

    In the United States, the First Amendment of the US Constitution guarantees freedom of speech, freedom of peaceable assembly, and the right to petition for redress of governmental grievances.

    Americans have been exercising these rights for over 200 years. If past activists had followed the instructions of these patients to behave in a quieter, more polite manner, women still wouldn’t be allowed to vote. There would be no labor unions, African-Americans would still be segregated, and LGBT people would still be in the closet - if the AIDS epidemic hadn’t wiped them out completely.

    The tactics being used by the new wave of ME advocates are standard tactics which have been used for over 200 years: writing critical articles, demonstrations, petitions and letter campaigns, with a few new twists like the use of social media and documentaries. There is nothing radical, illegal or immoral going on here. Nobody has barricaded themselves in a federal building with an arsenal of weapons and explosives.

    The definition of insanity is to repeat the same tactics over and over expecting different results. The ME and CFS community has been mostly using its “inside voice” for over three decades with the occasional assertive speech at government controlled functions and small demonstrations. If it was going to bring anything more than a few incremental crumbs, it would have worked a long time ago.

    Therefore, we must try something different. We don’t know which tactic is going to work, so we must try everything we can think of if we want to be successful. For example:

    • If being quiet and polite hasn’t worked, we should get louder and use our “outside voices”.

    • If working for change within the government hasn’t brought us the robust unbiased research we desperately need, we should crowdfund our own private research while we push for real government funding.

    • If patients are too sick to physically protest, we should try to get healthy people involved in our cause.

    This doesn’t mean that previous methods should be thrown out the window, but we must also be open to new ideas and tactics, and practice all of them simultaneously.

    As we have written previously on various blogs on MEadvocacy.org, we are up against an extremely entrenched institutional bias which believes that our disease is at least partially psychosomatic.  Accordingly, we don’t deserve the sort of robust research and treatment you would give to someone with a “real” disease like multiple sclerosis, HIV or cancer. This is not going to change without a lot of leverage.

    Consequently, if we are going to be successful, we must be brave and overcome our fear and distaste of speaking out loudly and boldly. If somebody wants to use that against us, we need to expose these tactics for what they are - not shrink away in fear or attack those who speak out.

    Those who chastise advocates for doing their jobs are essentially attempting to suppress their First Amendment rights. So to chastisers who tell us to be quiet, we say - “no”, we will not be polite and submissive because we don’t want another 30 years of the status quo for our disease.

     

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  • Featured post

    Misinformation About a Disease Has Dire Consequences

     

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    __________________________________________________________________ 

    Many look to our ME and CFS clinicians to transform into white knights coming to the rescue of a very neglected and mistreated patient population. More specifically, to take up the battle to confront the biased government institutions.

    We suspect politics are at play, and understand many of the well-known clinicians have become reliant on government funding or fear government retribution. How do they fight without losing their ability to run their clinics? Can they strongly speak out against the government and stop perpetuating the inaccurate institutional bias causing neglect and harm? Especially when these are taught to the thousands of doctors and medical professionals.  

    We are grateful for the researchers and clinicians who have not been biased and have worked hard in our community to do research and treat patients in this hostile climate.

    __________________________________________________________________

    Misinformation at the CDC Grand Rounds

    The Chronic Fatigue Syndrome: Advancing Research and Clinical Education, CDC Grand Rounds took place on February 16, 2016. See video of entire meeting here.

    There were four speakers at the meeting: Dr Charles Lapp, Dr. Elizabeth Unger, Dr. Anthony Komaroff and Dr. Avindra Nath. For this blog we will concentrate on Dr. Lapp’s presentation.

    Charles W. Lapp, MD - Medical Director, Hunter-Hopkins Center, P.A.: “Clinical Presentation of Chronic Fatigue Syndrome" - (Watch Dr. Lapp’s presentation here.)

    MEadvocacy initiated and delivered a petition to the National Institutes of Health (NIH) and Centers for Disease Control (CDC) for a cancellation of the intramural NIH study as presented on the NIH website (see archived link) and for the cancellation of Dr. Nath’s presentation to the CDC Grand Rounds.

    MEadvocacy and the 725 signers of the petition wanted to avoid misinformation being disseminated to the medical professionals listening to the presentations.  Had we known about the content of Dr. Lapp’s intended address about the disease, we would have called for a boycott of this as well.

    One has to think that Dr. Unger, Chief, Chronic Viral Diseases Branch at CDC, who headed this meeting, was very well aware of the content of Dr. Lapp’s speech. This is deeply concerning. We are not sure how many medical professionals actually attended this meeting but, we were told it would be in the thousands. Because this presentation is now available for viewing by anyone, that number could reach tens of thousands of doctors.

    Teaching flawed information to thousands of medical professionals is alarming and has dangerous consequences for patients who rely on their physicians to be informed.

    Lapp’s presentation included the following which are misguided and misleading to viewers:

    • Chooses to call the disease “chronic fatigue syndrome” throughout his presentation, because ‘fatigue’ is the predominant symptom.

    • Lists 7 names for the disease but, leaves off myalgic encephalomyelitis (ME) - despite this being the historical name and the preferred name by a large percentage of patients.

    • States: “there is no explanation as to why patients contract chronic fatigue syndrome”.  (This is not true - there are many different hypothesis - but no consensus at the moment. He also omits the fact that dozens of outbreaks of the disease have occurred over the decades.)

    • Uses the image on his slide of a woman in a suit, at a computer, putting her head down, portraying the misconception of this disease as just “tiredness”and reinforces the myth that it's a woman's disease.  

    • Citing a sample patient examination, Dr. Lapp states: “there was no immediate orthostatic blood pressure drop” upon standing, making this examination “unremarkable”.  He does not further explain that if a doctor waited additional time, the blood pressure drop could have been seen for ME patients with orthostatic intolerance.

    • Does not inform medical professionals about important tests such as checking for viral DNA and panels for viruses such as EBV, CMV and HHV-6 to identify infection or reactivation due to immune system dysfunction, as well as test for natural killer cell function which have shown to be abnormal in ME.

    • Proposes a prognosis for adults for improvements at 40%. - He does not explain that it is marginal levels of improvement that most often occur and that patients do not regain substantial amount of functionality.   His statement also does not describe typical disease progression for patients who fit the CCC/ICC criteria.

    • Recommends patients educate themselves about the disease by going to the CDC website, despite its many misrepresentations of the disease and lack of representing the moderate to severe levels of disease.

    • He recommends behavioral modification (cognitive behavior therapy (CBT)), as well as graded exercise therapy as treatments (GET), i.e., the PACE treatment program which is at best, ineffective, and at worst, harmful.

    • Dr. Lapp fails to mention current attempts of a large number of ME researchers, advocates, and patients working towards retraction of the flawed PACE Trial study from which the CBT and GET recommendations are based.

    • For pharmacologic treatment he recommends antidepressants, but doesn’t warn that some patients might be intolerant to these type of drugs.

    • There is no mention of antivirals or Low Dose Naltrexone (LDN) which have been helpful to some ME patients. In addition, he does not state that there have been successful results of Ampligen and Rituximab helping patients in ongoing clinical studies.

    ME experts have created an International Consensus Primer for Medical Practitioners (ICC) that covers diagnosing and treatment. The CDC should disseminate this material.

    Advocates and patients who have been following the CDC’s website data are appalled that outdated and harmful education information still appear on the website. CFSAC voting members recommended its removal long ago!

    CDC’s website contains too much emphasis on fatigue and recommendations for the harmful treatments of GET and CBT. Statements like “stabilize and improve over time” and “as tolerance develops” have doctors expecting patients to “recover” if they do CBT and GET. This is a false narrative for too many patients.  Doctors have been known to blame the patient for not improving despite the patient doing everything the doctor has asked.

    Multiple statements on the CDC website mislead doctors to believe that tolerance to activity will develop in all patients.  In many cases tolerance to activity never develops.  Patients learn to live inside a limited envelope of activity.  The most severe are limited to existing in darkened rooms with minimal contact with the outside world.

    In addition, more misinformation appears on CDC’s website with their continuing medical education (CME) courses, despite CFSAC’s recommendation to have these removed.  One of these educational videos for medical professionals from 2012 show Dr. Lapp, Dr, Bateman and Dr. Komaroff  (here, free registration for Medscape needed). 

    2016 Lapp CDC quote.PNG

    In the video, a discussion ensues in reply to Dr. Komaroff’s question whether patients are better off receiving a diagnosis (27:43):

    Dr. Komaroff: "Now I think that's, I agree with both of you, I would say on occasion I've seen a patient where I worried that maybe getting the label had made them less functional. They, they now seem to not be as active, as socially uh involved as they had been before. And there is a threat theoretically of labeling, but most of the patients are so glad to, to hear a doctor say I know what you have, I wish I knew what caused it and I wish I had a perfect treatment, I don't, but I think I will be able to help you with the symptoms of this illness."

    Dr. Lapp:Were you referring to illness behavior Dr. Komaroff? The, uh, if, if someone gets a label like chronic fatigue syndrome, um, they start behaving like they should be ill or, or trying to meet the diagnosis.”

    Dr. Komaroff:Yeah.

    Dr. Lapp: “And I suppose that's possible, but I mostly see that where there are disability issues involved where the insurance companies and to a lesser extent, say Social Security, requires that the patient have a certain level of illness and unable to work and so they try to meet that goal and to, uh although that's not a major problem in my estimation.”  [verbatim transcription]

    Dr. Komaroff worries about patients “seeming” to be less active because it’s theoretically possible (because CFS is considered to be psychosomatic).

    Although Dr. Lapp’s statement is softened with a backpedal of illness behavior not being a major problem, that doesn’t totally negate his first statement. In other words, if illness behavior is not a major problem, it must be a minor problem, therefore, it exists to a certain extent.

    This makes it sound like a) the disease is not that serious, b) some patients will become less functional because once they are labeled they are too focused on their symptoms which then results in a psychological worsening of symptoms and c) patients are purposefully malingering to get on disability so they can have a free ride.

    This is inappropriate. This sort of thing would not be discussed for cancer, HIV or multiple sclerosis. Discussions about illness behavior are common for diseases they think are at least partially psychosomatic and have no place in a teaching video about ME.

    Misinformed Doctors Perpetuate the Problem

    Is it surprising then that NIH picked Dr. Walitt (see Jeannette Burmeister’s great analysis of Dr. Walitt here) for their intramural study on post infectious CFS?  The more you dig into several of the co-investigators, you find similar theories of CFS being a psychosomatic illness.

    This psychosomatization of the disease has caused immeasurable harm to ME patients.  It is disappointing that Dr. Unger, who oversees ME/CFS at the CDC, is the cause of much of the misinformation and thereby the cause of medical abuse. 

    Click here to see Unger speak of psychosomatic illness during the Chronic Fatigue Syndrome Advisory Committee Meeting, October 2010.

    2016 Lapp CDC Unger quote.PNG

    Dr. Unger: “Just let me say that I, I think, um, there has never been any doubt in the CFS program at CDC that there is a biologic basis for this illness. Um, and I think it's, it is not code speak in our mind if we talk about  psychosomatic illness, it is a reflection of the mind/body connection. Um, and, I think that is one of the, the things our society does not do a good job of understanding - there is a mind/body connection. And when you start, um, understanding how people respond to their illness, and, and how their illness affects them, it is a circle.” [verbatim transcription]

    This sort of thinking matches the biopsychosocial model of CFS popular in Britain: that at one point the patient was actually sick with a biological disease, such as a viral infection, but now, they only think in their minds that they aren’t able to do activities like they could before. Therefore, with the aid of cognitive behavior therapy and graded exercise, they can be coaxed out of their “false illness beliefs” and become recovered.

    Once again, this is inappropriate. This sort of thing would not be discussed for diseases which are thought to be purely biological, only for diseases they think are at least partially psychosomatic.

    Note that Dr. Unger is also part of the new NIH study on ME/CFS.

    My Life Mattered: Chardale Dotson Irvine

    ChardalDotsonIrvineHeadstone.jpg

    "I told you I was sick"

     

    For an example of how a psychosomatic bias harms patients, see the tragic story below: the result of medical misinformation and abuse. Unfortunately, this story is not unusual for ME patients.

    During the anniversary week of Chardale Dotson Irvine’s death on Feb. 20, 2015 (officially declared on Feb. 22), Walter Irvine is honoring his wife by sharing her last testament.

    She desperately wanted him to share her story, to advocate for recognition of the disease myalgic encephalomyelitis [ME] in the USA, and raise research funding specifically for ME.


    “My onset was February 7th, 1996. I was not able to acquire specialty treatment until September of 2014.  Thousands and thousands of dollars spent on tests over the years. Hundreds of abusive doctors, predatory doctors, and inappropriate medication regimes...

    It’s common for it [ME] to be transferred from one family member to the other. Although they haven’t found a pathogen and so they understate this and act as if they don’t know, but they do.

    I have proven reactivated Epstein-barr at this moment, Coxsackie A & B and disseminated herpes simplex 1. These are the active viruses that we know about. There are probably other things going on. These are the testable ones that we have right now and nobody cares. And nobody cares that my husband acquired this as well. NOBODY CARES.

    So here’s the wake up call people.  My life mattered, and it matters.

    I brought three beautiful kids into this world. Amazing people. And 7 grandkids, 2 stepkids... I want them to have a better life. I want them to be treated with compassion and respect. And I want them to know that I didn’t crawl into a corner and die.

    I went out with a message. I went out demanding that people with myalgic encephalomyelitis get treatment and care and that research money go towards them....”

    [transcription by and emphasis added by Tracey Smith]

    ____________________________________________________________________________

    Click here to visit ME/CFS Memorial Page on Facebook, and here for the website National CFIDS Foundation: In Memoriam.

    Please note: *The article has been updated with verbatim transcriptions from the two videos. All blogs are a composed effort by the Advisory Group irrespective of the name appearing on the byline.

     

     

     

     

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    Eileen Holderman CFSAC Public Comment About NIH Study

     

     

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    CFSAC

    Public Comment

    May 18, 2016

    Eileen Holderman

     

    Good afternoon to the Advisory Committee Members and to all stakeholders listening. 

    My name is Eileen Holderman - I'm an advocate for ME, GWI and other neuroimmune diseases. 

    Recently, I served as consultant to MEadvocacy, an organization advocating on behalf of nearly 1 million American men, women and children suffering from Myalgic Encephalomyelitis (ME). 

    Specifically, I collaborated on their blogpost titled, "NIH Sidesteps Critical Problems with the ME/CFS Study," which is a detailed analysis of the numerous problems with the study design and protocol and which offers solutions to those problems.  The organization has given their consent for me to talk about the blogpost. 

    The blogpost outlines many problems such as: multiple and ever-changing criteria - some which are deeply flawed, biased and/or inexperienced investigators and advisors such as Walitt, Gill, Saligan and Unger, additional problems with the study design such as a small cohort size, excluding patients who are most severely affected such as the homebound and bed bound, the use of Lyme Disease comparison groups which will cloud the results, the exclusion of the 2-day CPET testing for PENE, the refusal to release the specific budget for the study, the exclusion of ME experts when designing the study, and finally, the failure to set up a transparent, 2-way communication and participation process between NIH and the ME community (researchers, clinicians, advocates, patients, and caregivers) at every step of the way. 

    Obviously, with just 3 minutes allotted for public comment, I cannot address all the problems mentioned, but invite all of you to visit the web site MEadvocacy.org and click on the blogpost for a detailed analysis that proposes solutions. 

    Therefore, with the remaining time I have, I will focus on the critical issue of the study's criteria. 

    It is of utmost importance that the strictest criteria - the CCC or ICC - developed by our ME experts - not by the CDC or Government agencies - be used in studying ME, in order to ensure that investigators are looking at a homogeneous patient cohort. 

    The NIH Intramural ME/CFS Study has changed criteria 6 times.  First, NIH announced they would use the Reeves' criteria - which has been rejected by mainstream scientists and denounced by CFSAC.  After backlash from advocates, NIH announced the study would utilize the CCC, IOM, Fukuda and Reeves'.  After more protest from advocates, NIH then announced they would use multiple consensus criteria, including Canadian criteria.  Then Dr. Nath stated that NIH would use the Fukuda and CCC.  After the NIH Telebriefing, a new web site for the study showed one specific criteria to be used - the CCC.  Finally, Dr. Koroshetz, in his letter to MEadvocacy, stated that the CCC and IOM would be used for selecting patients for the NIH study. 

    For over 30 years, US Government health agencies have created erroneous definitions and names for this specific neuroimmune disease - Myalgic Encephalomyelitis - causing devastating harm to patients.  And other nations, like the UK, who created the flawed Oxford definition used in the PACE Trial, have done the same. 

    Our community needs NIH to step up and officially state that the Reeves' criteria and questionnaires will not be used in the NIH Intramural Study for ME/CFS; resolve the outstanding problems with the study design and protocol; and establish a transparent, 2-way communication and participation process with all ME experts

    Thank you.

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