Tuesday, December 16, 2014

Large-scale analysis shows brain inflammation is a hallmark of autism - Parallels with ME/CFS?

A large-scale autopsy study performed by Johns Hopkins has revealed that the brains of people with autism show chronic inflammation produced by microglial activation. This study echoes recent findings by Nakatomi et al. showing microglial activation in the brains of people with ME/CFS.

Microglia are the first line of immune defense in the central nervous system, which means microglial activation is an indicator of inflammation. Chronic activation of microglia can lead to excitotoxicity, a mechanism that has been previously proposed for both Gulf War Illness and Autism (Blaylock, "Chronic Microglial Activation and Excitotoxicity Secondary to Excessive Immune Stimulation: Possible Factors in Gulf War Illness and Autism”). The John Hopkins study acts as confirmation that excitotoxicity caused by chronic inflammation is central to autism.

Excitotoxicity has been put forth as a mechanism of ME/CFS by a number of clinicians and researchers, including Drs. Paul Cheney, Jay Goldstein, Morris and Maes, Martin Pall, and, most recently, Jarred Younger.

What are the implications of this study for ME/CFS? As many have stated, it is clear that there is a connection between neuro-inflammation and a number of illnesses that show CNS and immune abnormalities. This study provides anatomical proof of inflammation in the brains of one of the illnesses on the neuro-immune spectrum, which opens the door for badly needed autopsy studies on ME/CFS patients, particularly those with severe illness. 

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Brain inflammation a hallmark of autism, large-scale analysis shows

By Shawna Williams

Press Release: Johns Hopkins, December 10, 2014. While many different combinations of genetic traits can cause autism, brains affected by autism share a pattern of ramped-up immune responses and related inflammation, an analysis of data from autopsied human brains reveals.

The study, a collaborative effort between Johns Hopkins and the University of Alabama at Birmingham, included data from 72 autism and control brains. It was published online last week in the journal Nature Communications.

"There are many different ways of getting autism, but we found that they all have the same downstream effect," says Dan Arking, an associate professor in the McKusick-Nathans Institute for Genetic Medicine at the Johns Hopkins University School of Medicine. "What we don't know is whether this immune response is making things better in the short term and worse in the long term."

The causes of autism, also known as autistic spectrum disorder, remain largely unknown and are a frequent research topic for geneticists and neuroscientists. But Arking had noticed that for autism, studies of whether and how much genes were being used—known as gene expression—had thus far involved too little data to draw many useful conclusions. That's because unlike a genetic test, which can be done using nearly any cells in the body, gene expression testing has to be performed on the specific tissue of interest—in this case, brains that could only be obtained through autopsies.

To combat this problem, Arking and his colleagues analyzed gene expression in samples from two different tissue banks, comparing gene expression in people with autism to that in controls without the condition. All told, they analyzed data from 104 brain samples from 72 individuals, the largest data set so far for a study of gene expression in autism.

Previous studies had identified autism-associated abnormalities in cells that support neurons in the brain and spinal cord. In this study, Arking says, the research team was able to narrow in on a specific type of support cell known as a microglial cell, which polices the brain for pathogens and other threats. In the autism brains, the microglia appeared to be perpetually activated, with their genes for inflammation responses turned on.

"This type of inflammation is not well understood, but it highlights the lack of current understanding about how innate immunity controls neural circuits," says Andrew West, an associate professor of neurology at the University of Alabama at Birmingham who was involved in the study.

Arking notes that, given the known genetic contributors to autism, inflammation is unlikely to be its root cause. Rather, he says, "This is a downstream consequence of upstream gene mutation."

The next step, he says, would be to find out whether treating the inflammation could ameliorate symptoms of autism.

Other authors on the study are Simone Gupta, Shannon E. Ellis, Foram N. Ashar, Anna Moes, Joel S. Bader, and Jianan Zhan, all of The Johns Hopkins University. The study was funded by the Simons Foundation and the National Institute of Mental Health.

Journal Reference: Simone Gupta, Shannon E. Ellis, Foram N. Ashar, Anna Moes, Joel S. Bader, Jianan Zhan, Andrew B. West, Dan E. Arking. Transcriptome analysis reveals dysregulation of innate immune response genes and neuronal activity-dependent genes in autism. Nature Communications, 2014; 5: 5748 DOI: 10.1038/ncomms6748

Saturday, December 13, 2014

US Disabled Hold Protests at Bethesda

Photo credits Christine Jarrett
By Russell Logan

From Press Release: December 10, 2014. Protesters rallied outside the NIH campus in Bethesda MD on December 10, angry at the US government’s continued neglect and mistreatment of one million disabled Americans with ME (myalgic encephalomyelitis).

National Institutes of Health (NIH) officials were bunkered down in a special P2P meeting to plan the government’s ongoing response to patient concerns.

The protesters demanded the government adopt the Canadian Consensus Criteria (CCC) for ME, already well accepted and supported by researchers and clinicians, and the cancellation of the IOM (Institute of Medicine) contract to redefine ME.

Protest organizer Tom Jarrett, of Westfield, IN, was among those calling for a halt to the ME redefinition report being produced by NIH and the Department of Health and Human Services (HHS), which they think will set back their cause by decades.

Jarrett says that although he has lost his livelihood as a former estate and certified financial planner to ME, he has not lost his fighting spirit.

“NIH is not truly listening to what the patients say. Internal NIH emails obtained through a FOIA lawsuit stating ‘File all these responses. No need to answer them directly’ prove this claim,” he said.

“They have a pre-set agenda for this P2P workshop and the corresponding IOM redefinition effort, and they intend to carry it out regardless of what patients and their doctors say. We are here to protest these redefinition projects that waste taxpayer money and harm patients by moving research backward in time, away from neuro-immune biomarkers, and toward the generic symptom of fatigue.”

ME patients have formed a new advocacy body in response to NIH neglect. ME Advocacy already has established a fighting fund and has engaged a prominent public relations firm to further their cause.

“There is so much at stake here for my family and for the ME community,” Jarrett said. “Will the P2P meeting and resulting report result in decades more of neglect, while my sons grow up without a healthy father, and patients with ME suffer and die, saddled with a vague disease definition, a trivializing name, and no hope of a cure? I don’t think so, because we patients will keep fighting until the NIH stops and truly listens to our voices.”

For nearly 30 years, people with the debilitating disease, ME, often referred to in the US by the disparaging name of “chronic fatigue syndrome”, have suffered the ravages of a neuro-immune disease that has left many confined to their beds or homes in pain and dysfunction.

Since the reported outbreak of the disease in Incline Village, Nevada in the mid 1980s, the federal government has done little to support research into ME.

A scant 5 million dollars per year has been allocated for research into ME, a disease that affects more than one million Americans and which costs the country more than $17 billion annually in lost productivity and medical costs.


So little has been spent on educating physicians about the disease that fewer than 15% of doctors can explain what it is.

About the Author: Russell Logan has worked in advertising and magazine publishing for 30 years. He was a government speech writer, managing editor of the Brisbane Weekly magazine and ran his own magazine publishing company until forced into early retirement through ill health with ME. He has battled with moderate to severe ME for 25 years. He now lives in Noosaville, Australia, where he edits Shoutout About ME, an online magazine with breaking news about ME events, advocacy, and research.










Wednesday, December 3, 2014

Help the National ME/FM Action Network win $5000!

Thank you to everyone who voted!! The National ME/FM Action Network made it to the finals! It will now receive $5,000 and is eligible for a possible grand prize of $100,000 in January.  

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You can vote once a day, every day, until the semi-finals are over on December 10. 

Voting is easy. Just sign in automatically with your Facebook account and click on Vote. (You can also sign in with your email.) 

The National ME/FM Network is currently in 19th place, up from 20th place yesterday. To boost them into the top rank vote HERE.

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From the website:

Advancing Research in Canada for Myalgic Encephalomyelitis and Fibromyalgia

The NATIONAL ME/FM ACTION NETWORK is a Canadian charitable organization dedicated to Myalgic Encephalomyelitis (ME), also known as Chronic Fatigue Syndrome (ME/CFS) and Fibromyalgia (FM) through support, advocacy, education and research.

The 2010 Canadian Community Health Survey (CCHS) conducted by Statistics Canada revealed that there were 411,500 Canadians diagnoses with ME/CFS and 439,000 with Fibromyalgia. The survey also revealed a high level of disability for patients with ME/CFS and FM as well as unmet health care needs. ME/CFS and FM are chronic and severely disabling illnesses. They are as disabling as MS and are more prevalent in Canada than breast cancer, MS and AIDS combined! People are frequently bedridden and become isolated from friends and family – invisible in their own communities. These illnesses are real; the people are real; and they need help NOW!

These illnesses do not discriminate. All races, men and women, rich and poor, adults and children can be afflicted. It is devastating when a child is forced to cope with such a disabling illness.

Currently there are no definitive biomarkers or treatment protocols for ME or FM. Diagnosis is made by comparing patient symptoms with diagnostic criteria, then excluding other possible causes of those symptoms. Treatments are merely a means to manage the symptoms. There is no known prevention or cure. Lacking these basic fundamentals has an enormous impact on our current community and the thousands of people still struggling to be diagnosed. It typically takes years to obtain a proper diagnosis and it’s known that early intervention increases the chance of recovery. We need more research now!

To date, minimal funds have been available resulting in little biomedical research in Canada for these illnesses. Our Canadian patient community are asking for and are in need of biomedical research and solutions. Internationally, patient groups are beginning to take a leadership role by organizing and fundraising to advance research. It’s time Canada takes a lead role in advancing research and shines a light on the severity and complexities of these illnesses.

With the proceeds from the Aviva contest, the National ME/FM Action Network will establish a research arm that will take on the challenge of advancing biomedical ME and FM research in Canada. This will require some legal and accounting expenses. We will unite Canada’s experts and assemble an advisory group, establish our research criteria, investigate the various research opportunities requiring funding, choose our first project and support the execution and reporting of its results in 2015. The research project will incur expenses for salaries for research personnel (postdoc and graduate students) to conduct the study and prepare a paper for publication, expenses for sample selection and participant coordination, cost of laboratory materials used, and charges for use of a facility’s equipment for analysis of the samples. Also a webinar is planned to share the results. We have several exciting research opportunities to choose from to pursue and complete in 2015 that will benefit not only Canadians but millions of people worldwide, today and in the years to come. To support our researchers, we will use a portion of the funds to complete an international investigation of options to make a biobank available for future Canadian research projects. We also use funds to engage our patient community to determine their preferences for future projects and to communicate our plans with them and the media. Additionally, we will work to build on our relationship with government to obtain long term funding for other projects and to increase their awareness of the 850,500 Canadians in need of their support. This will involve the expense of meetings, mailings and possibility the hiring of a grant writer. The Aviva funds will permit us to solidify the direction of research in Canada and make a significant contribution towards improving the lives of current and future ME and FM patients.

Aviva’s gift will help to us make a difference to the lives of many Canadians.

It will give us credibility in our quest for answers and solutions and hope for a better tomorrow.

VOTE HERE.

Tuesday, November 25, 2014

"Let's Blow The Lid Off This Thing!": ME advocacy group initiates national media campaign

To donate to the national PR campaign click HERE.

From ME Advocacy.org


Now Is the Time for a National PR Campaign for ME/CFS!
"HHS, NIH, fasten your seat belts and return your tray table to the upright position because it's going to be a bumpy ride:)" Susan Maier (NIH)

I'm sure Ms. Maier didn't realize just how prophetic her statement would become. ME patients are disgusted and disgruntled with the mistreatment perpetrated on this extraordinarily sick population by the NIH and CDC. We're mad as hell, and we're not going to take it anymore!

With FOIA access gained to internal documents from the IOM and P2P projects, the upcoming final P2P workshop, as well as upcoming IOM and CDC Multisite results, the time is now perfect for an all-out publicity campaign.

Let's Blow The Lid Off This Thing!

As great as our grassroots efforts have been, it's clear we need to apply even more pressure to achieve our goals.  First, we must demand that the three redefinition projects, the IOM, the P2P and the CDC Multisite Study, are stopped immediately. Their possible achievements are dubious at best and a waste of taxpayers’ money.  Secondly, we must demand that the Canadian Consensus Criteria (CCC) be adopted as the official definition of ME. Research using various definitions and cohorts renders the results uncertain. It’s imperative that a single clear definition, which includes the hallmark symptom of post exertional relapse, is used for diagnosis and research.

We're talking about turning up the heat 1000 degrees and blowing the lid off this thing. We’re talking about an all-out campaign which will make both the US public and our policy makers in Washington sit up and take notice. We're talking about demonstrations and having our spokespeople in the national media.

How can we possibly pull off such a thing?  Because all of us are incapacitated to some degree, this type of national campaign has never been done before.  The obvious answer, therefore, is to hire an innovative public relations firm to handle most of the work for us! 

As a community, we have raised $20,000 for the documentary, "The Forgotten Plague", and a whopping $213,000 for, "Canary In A Coalmine".  So we know that for the right project, big money can be raised.  We are asking for $26,400 which will finance a 6 month public relations campaign. The amount is not small, but we feel it's quite doable.  Are you fired up?  Are you ready to get this done once and for all?!  We think you are!

Are you fired up?  Ready to get this done once and for all?!  We think you are!

The Proposal

Here is the proposal from our intended PR firm, Crowds On Demand:

With a strong Public Relations campaign, the fight to stop the unjustified redefinition of ME is an issue that we believe will resonate well with the American public.

Complete lack of visibility is the major problem the movement is experiencing. Most Americans do not know about these changing definitions because the issue has not been covered by major media outlets or championed by any high profile policy maker. To be blunt, most Americans don’t know the reality of ME!

Hiring the innovative PR firm, Crowds on Demand, provides the opportunity to bring concerns about the NIH/CDC redefinitions to the public and get the issue the attention it deserves. The firm is known for an "outside the box" approach that has successfully assisted people and organizations in getting on the map. Unlike many firms, we do more than contact media outlets, we coordinate campaigns from the ground up involving lobbying, demonstrations and media relations.

Crowds on Demand will contact media, arrange for interviews on high profile shows (particularly morning shows), organize demonstrations and recruit policy makers to join the fight. Moreover, we will assist in the fundraising process by helping to make strategic partnerships with influential organizations and donors.

We have agreed to work for a heavily discounted rate of $4400 per month including all of these services because we believe in the cause (normally we would charge approximately $10,000 per month for such a campaign). Furthermore, we promise results within 6 months and promise a 50 percent refund if the organization is not satisfied.

A PR campaign with Crowds on Demand will get the cause on the radar and help the organization raise substantial funds from a donor network. We have excelled in the past working to bring attention to non-profits. For example, Crowds on Demand has worked with a relatively unknown charity in Los Angeles that worked on homeless mental health issues. It was originally unable to fundraise much or get attention. Through its campaign with us, they substantially increased fundraising and got attention in the media.

We want to bring our success to fighting the HHS’s ludicrous redefinition campaigns and getting the CCC universally adopted.

Adam R. Swart

Email: adam@swart.org

Cell:  650-353-0083

Click HERE to read the Full Proposal



About ME Advocacy.org

ME Advocacy.org is a project of May12.org. As May12.org is a 501(c)(3) not-for-profit corporation, all donations are tax deductible.

Both sites are run by patient volunteers, with none of the waste on salaries, buildings, and overhead associated with the large patient organizations. We are not affiliated with any government agency, and operate independently to enhance and support the campaigns already put in place by our patient advocates.

For your convenience, donations can be spread over 6 monthly payments. If 440 people donated $10 per month for 6 months we would reach our goal. We feel this is an affordable amount for many people.

To spread your donation over several payments, select the full amount you wish to donate, and then select the number of payments to make on this amount.

Please donate today!

Saturday, November 22, 2014

A Tale of Two Meetings: CFSAC and P2P

Two important meetings are scheduled for early December: CFSAC (CFS Advisory Committee) and P2P (Pathways to Prevention). The CFSAC meeting will be held on December 3-4. The P2P panel will meet on December 9-10. Both will be in Washington, DC and both are available via webcast.

CFSAC was formed in 2003 in order to provide advice and recommendations to the Secretary of Health and Human Services (HHS) through the Assistant Secretary for Health on issues related to ME/CFS. It is currently under the auspices of Office on Women's Health, a division of the Office of Public Health and Science.

In 2010 the committee advised HHS that the name chronic fatigue syndrome should be changed to CFS/ME because the disease wasn't being taken seriously. The idea was that the inclusion of ME might encourage more research into the illness. The CFSAC panel also recommended that a national CFS/ME network of treatment centers be created by HHS, "in order to expand access to care, to develop educational initiatives, and to allow researchers to share data."

Although the recommendations made by CFSAC over the years have been important, they have been ignored, or, even worse, "hijacked." The Federally Designated Officer, Nancy Lee, was considered a large part of the problem, and though she has been replaced is still a major obstacle to making significant progress. 

Of the two meetings, P2P will have the greater impact on the future of ME/CFS, for while CFSAC recommendations have been largely ignored, the P2P's conclusions will have an immediate effect on funding, and on subsequent treatment.

CFSAC is open to public comment. (Please see Jerrold Spinhirne's excellent comment below.)

If you would like to submit a public comment by phone to CFSAC, you must register by Monday, November 24th at 5pm. If you want to submit written comments, these are also due November 24th at 5pm. Registration and instructions for scheduling public comments and submitting public testimony are available at www.blsmeetings.net/cfsac. You can read the full agenda HERE.

If you would like to register to attend the P2P Workshop in person click HERE,

To register for the webcast click HERE


Advocates to NIH - "Pull the P2P!"

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My Public Comment for the December 3-4, 2014 CFSAC Meeting

Comment for the December 2014 CFSAC Meeting by Jerrold Spinhirne, S.E.

Some important quotes regarding the neurological disease myalgic encephalomyelitis (ME) and chronic fatigue syndrome (CFS):

1. Name: Myalgic encephalomyelitis, a name that originated in the 1950s, is the most accurate and appropriate name because it reflects the underlying multi-system pathophysiology of the disease. Our panel strongly recommends that only the name ‘myalgic encephalomyelitis’ be used to identify patients meeting the ICC because distinctive disease entity should have one name. Patients diagnosed using broader or other criteria for CFS or its hybrids (Oxford, Reeves, London, Fukuda, CCC, etc.) should be reassessed with the ICC. Those who fulfill the criteria have ME; those who do not would remain in the more encompassing CFS classification.

2. Remove patients who satisfy the ICC from the broader category of CFS. The purpose of diagnosis is to provide clarity.  The criterial symptoms, such as the distinctive abnormal responses to exertion can differentiate ME patients from those who are depressed or have other fatiguing conditions. Not only is it common sense to extricate ME patients from the assortment of conditions assembled under the CFS umbrella, it is compliant with the WHO classification rule that a disease cannot be classified under more than one rubric....

3. Research on ME: The logical way to advance science is to select a relatively homogeneous patient set that can be studied to identify biopathological mechanisms, biomarkers and disease process specific to that patient set, as well as comparing it to other patient sets.... Research on other fatiguing illnesses, such as cancer and multiple sclerosis (MS), is done on patients who have those diseases. There is a current, urgent need for ME research using patients who actually have ME. [Emphasis added]

– Myalgic Encephalomyelitis – Adult & Paediatric: International Consensus Primer for Medical Practitioners (Carruthers, 2012)

I felt for some time, Keiji, that those who have CFS are at a certain point along a continuum of illness in which fatigue is either the most dominant symptom or the most clearly articulated by virtue of impressions on the part of the patient or physician that such a complaint is important. I predict that fatigue itself will remain the subject of considerable interest, but the notion of a discrete form of fatiguing illness will evaporate. We would, then, be left with Chronic Fatigue that can be distinguished as Idiopathic or Secondary to an identifiable medical or psychiatric disorder. I consider this a desirable outcome. [Emphasis added]

– NIH official Stephen Straus in an undated letter to CDC epidemiologist Keiji Fukuda before the 1994 Fukuda et al. redefinition of chronic fatigue syndrome (Straus, undated)

We propose a conceptual framework to guide the development of studies relevant to the chronic fatigue syndrome. In this framework, in which the chronic fatigue syndrome is considered a subset of prolonged fatigue (>1 month), epidemiologic studies of populations defined by prolonged or chronic fatigue can be used to search for illness patterns consistent with the chronic fatigue syndrome.

Prolonged fatigue is defined as self-reported, persistent fatigue lasting 1 month or longer. Chronic fatigue is defined as self-reported persistent or relapsing fatigue lasting 6 or more consecutive months.

Diagnosis of the chronic fatigue syndrome can be made only after alternative medical and psychiatric causes of chronic fatiguing illness have been excluded. No pathognomonic signs or diagnostic tests for this condition have been validated in scientific studies; moreover, no definitive treatments for it exist.

[N]one of the provisions in these guidelines, especially the definition of idiopathic chronic fatigue and subgroups of the chronic fatigue syndrome, establish new clinical entities. Rather, these definitions were designed to facilitate comparative studies.[Emphasis added]

– Fukuda K, Straus SE, Hickie I et al. Chronic fatigue syndrome: a comprehensive approach to its definition and study. (Fukuda, 1994)

Fatigue is a totally undefinable concept. Fatigue is impossible to measure or quantify. Fatigue is so non-specific that it can be a common element in any acute or chronic disease and many psychiatric diseases. Worse, it redirects the medical and public attention to the totally undefinable fatigue and away from the obvious Central Nervous System changes in these patients. Much worse, it makes fun of a serious illness since most people and most physicians tend to equate fatigue with laziness, work avoidance, something that a bit of effort will chase away. It has turned out to be a damning indictment to all M.E. patients.

– Dr. Byron Hyde in a 2006 speech delivered in London

The recent Stanford brain imaging study (Zeineh, 2014), which found profound brain abnormalities in CFS-labelled subjects, is consistent with the neurological disease myalgic encephalomyelitis (ME) and shows the problem with the continued use the 1994 Fukuda "International" CFS case definition (Fukuda, 1994) to select research subjects for biomedical research. The results can only be applied to an undetermined subset of CFS patients which is never delineated.

The ME IC Primer (Carruthers, 2012), on the other hand, already lists brain abnormalities similar to those found in the Stanford study – white matter abnormalities and reduced regional gray and white matter volume – as associated with the neurological disease ME. ME is a well-described disease entity based on the documented, clinical observation by highly qualified medical doctors of thousands of actual patients with the disease. CFS, as it is currently case defined, is based on a political negotiation made between US Department of Health and Human Services (HHS) bureaucrats and medically unqualified UK psychiatrists in 1994. CFS corresponds to no single clinical entity ever observed in actual patients. In addition to chronic fatigue, the 1988 Holmes definition of CFS required 8 of 11 listed symptoms. The 1991 Oxford definition of CFS required no symptoms other than chronic fatigue. The CDC-assembled 1994 CFS definitional committee diplomatically split the difference and arbitrarily required any 4 of 8 listed self-reported and sketchily described symptoms for a case of CFS.

The Fukuda case definition of CFS is a research concept that is an abstraction. No extensive clinical observation of actual patients was considered. The definition was allegedly only intended as a theoretical framework to assemble research subjects who MIGHT have an identifiable disease. Inexplicably, this abstract research concept was turned verbatim into CFS diagnostic criteria that can still be found in the CDC's "CFS Toolkit" of diagnostic and treatment guidelines today, 20 years later. In other words, doctors are presently diagnosing and treating a research abstraction called CFS, rather than any actual disease – or even any related group of diseases – found in nature. 

The "encephalomyelitis" part of the term ME means inflammation of the brain and spinal chord. Brain inflammation was recently confirmed in ME patients selected using the International Consensus Criteria for ME. (Nakatomi, 2014; Carruthers, 2011) This is completely consistent with the Stanford brain study findings. Dr. E. Donald Acheson in 1959 reviewing 14 outbreaks of infectious disease, by then named myalgic encephalomyelitis, involving thousands of patients stated:

"All the outbreaks shared the following characteristics: (1) headache; (2) myalgia; (3) paresis [muscle weakness, partial paralysis]; (4) symptoms or signs other than paresis suggestive ofdamage to the brain, spinal cord or peripheral nerves; (5) mental symptoms; (6) low or absent fever in most cases; (7) no mortality." [Emphasis added] (Acheson, 1959)

The common symptom of fatigue is not even mentioned in classic descriptions of ME – not because ME patients did not experience and report fatigue, but because fatigue is such a commonly reported symptom that it is not useful for making differential medical diagnoses. The ME International Consensus Criteria (Carruthers, 2011) and IC Primer do not even list self-reported chronic fatigue, or any type of fatigue, as a symptom of ME. Responses to standard fatigue questionnaires are, therefore, of no use for diagnosing ME, or for measuring its severity or improvement. Nevertheless, the concepts of CFS, ME/CFS, and CFS/ME are all based on self-reported fatigue which is only "measurable" by questionnaires – the "instruments" of social science.

Many patients and media reports viewed the Stanford brain study as vindication that CFS is "real." However, by the currently used Fukuda definition, CFS can never be "real." The fatigue must be "unexplained" and "self-reported." The findings of the Stanford brain study are likely to be found as "exclusionary" for CFS by the dogmatic US Centers for Disease Control (CDC) – as they have found all similar physical findings in CFS-labelled research subjects for the past 26 years.

How could brain-scan abnormalities ever be a "biomarker" for the diverse group of patients assembled under the umbrella term CFS? None of the poorly described symptoms that might indicate some neurological involvement – "impaired memory or concentration," "headache of a new type or severity" and "unrefreshing sleep" – in the current "CFS Toolkit" is required for a CFS diagnosis. Abnormal brain scans could never be a biomarker for CFS because an unknown portion of CFS-diagnosed  patients is likely to have no physical brain abnormalities, whatsoever. If the Stanford subjects had been evaluated for ME using the ICC, which requires at least three symptoms indicating neurological impairment, the results could be applied to a specific patient group – the group with the neurological disease ME. Instead, biomedical research using nonspecific CFS-labelled subjects will keep going around in circles as it always has done and always will do.

The fatigue experienced by ME patients is no more "unexplained" than the fatigue experienced by cancer and MS patients. Because the fatigue experienced by ME patients is a bioalarm indicating an underlying disease process and not "unexplained," no patient with ME, strictly speaking, can meet the Fukuda case definition of CFS. The impossibility of a single patient simultaneously meeting both the ICC-ME and Fukuda-CFS case definitions makes the CFS-hybrid terms "ME/CFS" and "CFS/ME" ambiguous and nonsensical.

The CDC has consistently denied any neurological involvement in their conception of CFS. After a quarter century of CFS research, there is still no symptom suggesting any neurological disease or, indeed, the presence of any specific disease, required for a CFS diagnosis or for use as a CFS research subject. The problem is bad faith at the CDC and the rest of the Department of Health and Human Services – not the lack of scientific evidence.

If the CDC, NIH, psychologists, and psychiatrists wish to continue their research of the subjective symptom of chronic fatigue or their search for a distinct chronic fatigue syndrome and its elusive subgroups, they should not do so at the expense of patients with the distinct neurological disease myalgic encephalomyelitis. It is unethical and hypocritical of the CDC and the rest of HHS to keep ME hidden within a hypothetical chronic fatigue syndrome. There is an urgent need for ME, as defined by the ICC, to be officially listed as exclusionary for a CFS diagnosis or for use as a CFS research subject. Just as the presence of CFS subjects without ME confounds ME research, the presence of ME subjects without CFS confounds CFS research. If the CDC is sincere in wishing to research CFS, they should immediately announce that subjects with ME – just as subjects with other fatiguing diseases such as cancer and MS – should be excluded from use as CFS-labelled research subjects.

Copies of the ME IC Primer must be distributed to doctors so they can recognize and rule out ME before making a CFS diagnosis. Doctors must also be educated that in the new US ICD-10-CM, official October 2015, ME is coded for billing and reporting purposes as G93.3 as a neurological disease. CFS and unspecified chronic fatigue are codedtogether as R53.82 as general symptoms.

HHS could actually make itself useful by distributing the ME IC Primer to doctors and medical personnel and informing them how to use the new ICD-10-CM codes. Instead, HHS has chosen to engage in expensive boondoggles such as the unneeded, million-dollar HHS/IOM redefinition of "ME/CFS" or the useless, farcical NIH P2P "ME/CFS" Workshop. Both of these HHS initiatives are set up and stage managed so that they can only cause more confusion, more harm to patient care, and more confounding of research.

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

Carruthers BM, van de Sande MI et al. Myalgic encephalomyelitis: International Consensus Criteria. J Intern Med 2011; 270:327–38.

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

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.

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

Straus, Stephen. Undated letter on NIH letterhead to Keiji Fukuda quoted and posted online by Craig Maupin in The CFS Report, March 2014 post, 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

Zeineh MM, Kang J, Atlas SW et al. Right arcuate fasciculus abnormality in chronic fatigue syndrome. Radiology 2014; 273(2S). Published online October 29, 2014. 

Monday, November 17, 2014

Cochrane review finds CBT not effective for medically unexplained symptoms

When a physician fails to find a cause for physical symptoms (medically unexplained physical symptoms, or MUPS), the patient is usually given a diagnosis of 'somatoform disorder,' or "it's all in your head."

Somatoform disorder is a relic of Freudian psychology, whose disciples believed that underlying emotional distress could manifest itself in physical symptoms. While it is true that some forms of emotional trauma can produce a release of adrenal hormones, which will in turn raise blood pressure, increase heart rate, and cause other transient physiological symptoms, the idea that emotional distress can cause significant long-term physiological consequences (e.g. gallbladder disease, cancer, etc.) is completely unfounded.

Although there is no scientific basis for somatofom disorder, it has become widely accepted as a diagnosis because it is easier to relegate patients to the dustbin of "it's all in your head" than to devote the necessary time and effort to figure out what might actually be wrong with them. In a medical system in which physicians only have 10 minutes (at most) to spend with a patient, and in which doctors are discouraged from taking their patients' complaints seriously, but instead rely on the results of a few simple tests, the diagnosis of somatoform disorder is a convenient means of disposing of "difficult" patients.

The diagnosis also saves money. National health care systems and insurance companies are especially concerned with costly medical outlays for chronic illnesses, which are becoming increasingly common. They are likely to embrace the idea that MUPS can be treated with comparatively inexpensive therapy, rather than pursue a line of treatment that may involve extensive testing and expensive treatments.

ME/CFS falls into the category of MUPS, and as a consequence many patients with the disease are consigned to psychological therapy. While there has been a great deal of resistance on the part of patients and specialists to the idea that psychological interventions are a legitimate treatment for ME/CFS (treatment being defined as something that can affect the actual course of a disease, rather than provide solace), there has not yet been a careful, unbiased evaluation of therapy in MUPS.

This systematic review found that compared with usual care (which is in most cases minimal) patients with MUPS did slightly better with psychological interventions. However, when compared with enhanced, or specialized, care CBT was not more effective. This finding would seem to be obvious. For example, for patients with heart disease, seeing a cardiologist would clearly be more efficacious than receiving CBT. However, because the "it's all in your head" diagnosis has become so popular, the report could only conclude that CBT was not more effective than enhanced care. This is, in essence, a negative conclusion, but it is still valid as a critique of CBT employed instead of specialized care.

To their credit, the authors pointed out that the studies they evaluated did not include any patients who were unwilling to receive CBT, thereby skewing the results. (If studies only include patients who are positively disposed to receiving CBT, outcomes will be more favorable.) They also pointed out that while no harms were reported, the studies did not include harms as part of their outcome measures. (Absence of evidence is not evidence of absence.) They also noted a high drop-out rate, and the fact that the studies were unblinded. When combined, all of these factors can only lead to the conclusion that evidence in support of CBT and other psychological interventions for treating ME/CFS is weak by anybody's standards.

_____________________

Non-pharmacological interventions for somatoform disorders and medically unexplained physical symptoms (MUPS) in adults

By N. Van Dessel et al.


BACKGROUND: Medically unexplained physical symptoms (MUPS) are physical symptoms for which no adequate medical explanation can be found after proper examination. The presence of MUPS is the key feature of conditions known as 'somatoform disorders'. Various psychological and physical therapies have been developed to treat somatoform disorders and MUPS. Although there are several reviews on non-pharmacological interventions for somatoform disorders and MUPS, a complete overview of the whole spectrum is missing.

OBJECTIVES: To assess the effects of non-pharmacological interventions for somatoform disorders (specifically somatisation disorder, undifferentiated somatoform disorder, somatoform disorders unspecified, somatoform autonomic dysfunction, pain disorder, and alternative somatoform diagnoses proposed in the literature) and MUPS in adults, in comparison with treatment as usual, waiting list controls, attention placebo, psychological placebo, enhanced or structured care, and other psychological or physical therapies.

SEARCH METHODS: We searched the Cochrane Depression, Anxiety and Neurosis Review Group's Specialised Register (CCDANCTR) to November 2013. This register includes relevant randomised controlled trials (RCTs) from The Cochrane Library, EMBASE, MEDLINE, and PsycINFO. We ran an additional search on the Cochrane Central Register of Controlled Trials and a cited reference search on the Web of Science. We also searched grey literature, conference proceedings, international trial registers, and relevant systematic reviews.

SELECTION CRITERIA: We included RCTs and cluster randomised controlled trials which involved adults primarily diagnosed with a somatoform disorder or an alternative diagnostic concept of MUPS, who were assigned to a non-pharmacological intervention compared with usual care, waiting list controls, attention or psychological placebo, enhanced care, or another psychological or physical therapy intervention, alone or in combination.

DATA COLLECTION AND ANALYSIS: Four review authors, working in pairs, conducted data extraction and assessment of risk of bias. We resolved disagreements through discussion or consultation with another review author. We pooled data from studies addressing the same comparison using standardised mean differences (SMD) or risk ratios (RR) and a random-effects model. Primary outcomes were severity of somatic symptoms and acceptability of treatment.

MAIN RESULTS: We included 21 studies with 2658 randomised participants. All studies assessed the effectiveness of some form of psychological therapy. We found no studies that included physical therapy.Fourteen studies evaluated forms of cognitive behavioural therapy (CBT); the remainder evaluated behaviour therapies, third-wave CBT (mindfulness), psychodynamic therapies, and integrative therapy. Fifteen included studies compared the studied psychological therapy with usual care or a waiting list. Five studies compared the intervention to enhanced or structured care. Only one study compared cognitive behavioural therapy with behaviour therapy.Across the 21 studies, the mean number of sessions ranged from one to 13, over a period of one day to nine months. Duration of follow-up varied between two weeks and 24 months. Participants were recruited from various healthcare settings and the open population. Duration of symptoms, reported by nine studies, was at least several years, suggesting most participants had chronic symptoms at baseline.

Due to the nature of the intervention, lack of blinding of participants, therapists, and outcome assessors resulted in a high risk of bias on these items for most studies. Eleven studies (52% of studies) reported a loss to follow-up of more than 20%. For other items, most studies were at low risk of bias. Adverse events were seldom reported. For all studies comparing some form of psychological therapy with usual care or a waiting list that could be included in the meta-analysis, the psychological therapy resulted in less severe symptoms at end of treatment (SMD -0.34; 95% confidence interval (CI) -0.53 to -0.16; 10 studies, 1081 analysed participants). This effect was considered small to medium; heterogeneity was moderate and overall quality of the evidence was low. Compared with usual care, psychological therapies resulted in a 7% higher proportion of drop-outs during treatment (RR acceptability 0.93; 95% CI 0.88 to 0.99; 14 studies, 1644 participants; moderate-quality evidence). Removing one outlier study reduced the difference to 5%.

Results for the subgroup of studies comparing CBT with usual care were similar to those in the whole group. Five studies (624 analysed participants) assessed symptom severity comparing some psychological therapy with enhanced care, and found no clear evidence of a difference at end of treatment (pooled SMD -0.19; 95% CI -0.43 to 0.04; considerable heterogeneity; low-quality evidence). Five studies (679 participants) showed that psychological therapies were somewhat less acceptable in terms of drop-outs than enhanced care (RR 0.93; 95% CI 0.87 to 1.00; moderate-quality evidence).


AUTHORS' CONCLUSIONS: When all psychological therapies included this review were combined they were superior to usual care or waiting list in terms of reduction of symptom severity, but effect sizes were small. As a single treatment, only CBT has been adequately studied to allow tentative conclusions for practice to be drawn. Compared with usual care or waiting list conditions, CBT reduced somatic symptoms, with a small effect and substantial differences in effects between CBT studies. The effects were durable within and after one year of follow-up.

Compared with enhanced or structured care, psychological therapies generally were not more effective for most of the outcomes. Compared with enhanced care, CBT was not more effective. The overall quality of evidence contributing to this review was rated low to moderate.The intervention groups reported no major harms. However, as most studies did not describe adverse events as an explicit outcome measure, this result has to be interpreted with caution.An important issue was that all studies in this review included participants who were willing to receive psychological treatment. In daily practice, there is also a substantial proportion of participants not willing to accept psychological treatments for somatoform disorders or MUPS. It is unclear how large this group is and how this influences the relevance of CBT in clinical practice.The number of studies investigating various treatment modalities (other than CBT) needs to be increased; this is especially relevant for studies concerning physical therapies. Future studies should include participants from a variety of age groups; they should also make efforts to blind outcome assessors and to conduct follow-up assessments until at least one year after the end of treatment.


Source
: Van Dessel N, Den Boeft M, van der Wouden JC, Kleinstäuber M, Leone SS, Terluin B, Numans ME, van der Horst HE, van Marwijk H. Cochrane Database Syst Rev. 2014 Nov 1;11:CD011142. [Epub ahead of print]

Friday, November 14, 2014

"Government unreasonable": Judge Vince Chhabria orders HHS and NIH to pay fees in FOIA suit

On January 9, 2014, Attorney Jeannette Burmeister filed a federal lawsuit against HHS and NIH in the U.S. District Court for the Northern District of California for failure to comply with the requirements of the Freedom of Information Act (FOIA) regarding documents she requested relating to the Institute of Medicine (IOM) “study” of diagnostic criteria for myalgic encephalomyelitis/chronic fatigue syndrome. 

On September 2, the Court ordered the government to comply with Attorney Burmeister’s request. You can read the full complaint HERE.

Federal Court awards $139,147 in Attorneys’ Fees Against HHS and NIH in IOM FOIA Case

Reprinted with the kind permission of Jeannette Burmeister and Thoughts About ME.

By Jeannette Burmeister

The U.S. District for the Northern District of California awarded me today–having won my FOIA lawsuit–my entire attorneys’ fees in the amount of $139,147. Judge Vince Chhabria ordered the defendants, HHS and NIH, to pay me these fees. Please see below for a copy of the order.

In the Court’s order, the Judge noted:
Ms. Burmeister is clearly the prevailing party in the litigation. Moreover, as outlined in the order granting Ms. Burmeister’s motion for summary judgment, the government’s conduct throughout its dispute with Ms. Burmeister was unreasonable. Ms. Burmeister stood to gain nothing financially from her attempt to obtain documents at issue from the government, and she conferred a benefit on the public through her successful effort to obtain a ruling against the government. [emphasis added]
The defendants’ conduct in this matter has been absolutely deplorable. They have fought tooth and nail trying to avoid compliance with federal law and to delay production of relevant documents relating to the IOM project as long as possible. Throughout the entire proceedings, the defendants have acted unreasonably and shamefully, really, in their relentless attempts to circumvent their obligations under FOIA. Their inexcusable conduct has put me through the wringer, which has had a direct and dramatic impact on my health. I will share with the community, at a later time, details of the many instances of the defendants’ appalling actions in this matter. But here is a high-level list:

The defendants failed to make a determination in response to my FOIA request (from more than a year ago, seeking documents relating to the IOM contract with HHS) within the 20 business days required by FOIA. I waited several weeks and sent them one last communication notifying them that legal action was imminent. When they still did not respond, I brought my suit pro se, i.e. I was representing myself in an attempt to avoid attorneys’ fees. After I filed the lawsuit, defendants produced a mere 88 pages, only 22 relating specifically to the IOM (one of them blank), for a very high-priority and extraordinarily controversial $1 million project. It was clear that their search and production of documents was woefully inadequate (as the Court later agreed when it granted my motion for summary judgment). The defendant’s subsequent response to my complaint was, once again, late. It was then that I realized that they had no intention of complying with the law in response to my entirely reasonable and very straightforward FOIA request, even faced with a lawsuit.
Therefore, I hired the law firm of Baker & McKenzie LLP.

Every taxpayer dollar spent by HHS and NIH in this lawsuit–every single one–was caused by the government’s appalling tactics. Instead of remedying the inadequate search and production, they went into full-blown attack mode, filing a meritless and unwarranted motion, making frivolous legal arguments, making false statements under penalty of perjury, misrepresenting my statements and actions, misrepresenting legal authority, etc. They went so far as to accuse me of lying under penalty of perjury, which shows their mindset very clearly: Since they had no qualms about blatantly misrepresenting the facts, they thought accusing me of the same might work. It didn’t.

A few days ago, in response to the Judge’s order from September to produce all documents I sought, Counsel for defendants delivered about 4,300 pages of supposedly responsive documents demonstrating very clearly the laughable number of documents originally produced. A cursory review of those documents shows that their misrepresentations–again made under penalty of perjury and in opposing Counsel’s motions–were far worse than it initially appeared. It is also obvious that this new production is again inadequate and does not comply with FOIA in many respects.

The community will be extremely interested in seeing the documents that they produced recently. I will make every effort to publish those of interest (I will save myself the energy of publishing the NICE guidelines or the IOM Gulf War Report from earlier this year.) as quickly as possible, but my health has been very poor as a result of this litigation, so I ask for some patience.

I want to thank Patricia Carter, the owner of MECFS Forums, for providing a helpful declaration in support of my attorneys’ fees motion. I also want to especially thank Eileen Holderman, the former and most effective patient representative on CFSAC in its history, for her invaluable assistance, including providing a declaration in support of my motion. Finally, my sincere thanks go to my attorneys, Bruce Jackson, Edward Burmeister and Christina Wong, as well as paralegal, Nada Hitti, and assistant, Chris von Seeburg, for their unflagging efforts and excellent representation in this case.

Note: I owe the entire amount to Baker & McKenzie and I would have had to pay it regardless of whether the Court had awarded me the fees. What I am saying is that I don’t get to keep the money, just to avoid a misunderstanding on that front.