TAKE ACTION! Denounce Dr. Shorter Speaking at the NIH

Professor Shorter's invitation to speak at the NIH is a travesty.

Would a prestigious national institution invite a Holocaust denier to speak about World World II, or a member of the KKK to speak about race relations?

We can't know what they were thinking when the NIH extended their invitation to Dr. Shorter, who is certainly no expert on any aspect of ME/CFS. But we do know that inviting a man who is so outspoken in his absolute denial of the disease reflects very poorly on the attitudes of the institution that recently pledged to take ME/CFS "very seriously."

You can read more about Dr. Shorter's invitation as well as his disparagement of ME/CFS patients HERE. 

Dr. Shorter is scheduled to speak on November 9. Please send a letter to your representative today.


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I sent this little note to Dr. Collins:

To: collinsf@mail.nih.gov

Dear Dr. Collins,

I am sure you realize by now that the response to your invitation to have Dr. Shorter speak at the NIH has been less than positive.

Dr. Shorter is a crank. He has no expertise in ME/CFS - of any kind - and has made a reputation for himself by making outrageous statements worthy of the National Enquirer. The fact that he has published a book on the subject does not qualify him to speak as an expert. (I have published two books of more merit than his, and yet I do not recall receiving an invitation from you.)

In case you do not remember, you made a promise to take ME/CFS "very seriously." You asked the ME/CFS community to bear with you as you "ramped up" ME/CFS research. (We are still waiting for the ramping up.) Is being called "hysterics," "whiners," and "complainers" one of the things we must bear? Would you ask the same of patients with Parkinson's disease, Alzheimer's, or cancer?

What you have done is let a fox into the hen house. You have also done irreparable harm to the good will you built by appearing to offer a helping hand to patients who have suffered the ravages of this disease, and then dashing our hopes with this crude gesture of contempt.

Yours,

Erica Verrillo, author, Chronic Fatigue Syndrome: A Treatment Guide

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From Solve ME/CFS Initiative

BREAKING NEWS: Last week, deeply troubling information was discovered on an archived National Institutes of Health (NIH) webpage. A lecture titled “Chronic Fatigue Syndrome in Historical Perspective” is scheduled for Wednesday, November 9, to be presented by the controversial and inflammatory history professor Edward Shorter, PhD.

A professor of psychiatry and history at the University of Toronto, Shorter is an outspoken skeptic about the biological nature of ME/CFS. He has referred to the disease as both a “psychodrama” and a “psychic epidemic” and called the findings of the Institute of Medicine’s report on ME/CFS last year “junk science.”

Read more about this announcement here: http://solvecfs.org/disparaged-speaker-to-present-at-nih-next-week/.

The Solve ME/CFS Initiative is formally protesting the inclusion of Dr. Shorter as a speaker and writing to the NIH to ask them to provide scientifically grounded balance.

Read SMCI’s letter here: http://solvecfs.org/wp-content/uploads/2016/11/SMCI-Letter-of-Protest-Dr-Shorter.pdf.

We need your help in contacting your congressional representative ASAP to keep up the pressure on the NIH.

Follow these three easy steps below:

Step 1: Call your representative

To find your U.S. House of Representatives member, visit http://www.house.gov/representatives/find/.

Please note that this action is for REPRESENTATIVES ONLY, NOT SENATORS.

Please call the Washington DC office, not the district office, and ask to speak to the legislative assistant for health. If the legislative assistant is not available, you can ask to leave a message or immediately ask for the   e-mail address of the legislative assistant to send him or her your request in writing.

Feel free to tell the legislative assistant your story, but remember to be very brief. Use the sample script below as a guide.

My name is _________. I’m a constituent in {city}. I am calling with an urgent request for Representative {NAME} to contact the National Institutes of Health. The NIH has invited an inflammatory and controversial speaker, Dr. Shorter, who denies that ME/CFS is a physical disease. Between 1 to 2.5 million Americans like me [or my family member] who are afflicted with the horrific, disabling, and costly disease myalgic encephalomyelitis, also known as chronic fatigue syndrome or ME/CFS. ME/CFS has no known cause, cure, diagnostic test, or FDA-approved treatment, and it often leaves patients bedridden for decades. Please urge Representative {NAME} to support patients and voice their concern about this troubling speaker who calls me [or my family member] “delusional.” May I have your e-mail address to send you additional information?

If you do not receive an e-mail address for a particular staffer, ask for the general comment e-mail address.

Step 2: E-mail your representative

After you speak to the staff person by phone, it is always helpful to follow up with an e-mail. Download a helpful ME/CFS issue fact sheet here (http://solvecfs.org/wp-content/uploads/2016/11/SMCI-NIH-Response-Flaws-Flier.pdf) to include with your e-mail. Feel free to personalize the e-mail below.

Dear Congress Member [LAST NAME],

As a constituent and as a (caregiver to / loved one of) a patient with myalgic encephalomyelitis (ME), commonly known as chronic fatigue syndrome (CFS), I am bringing your attention to the immediate need for Congress to assist ME/CFS patients. In September, 55 bipartisan members of the House of Representatives joined together to write to NIH Director Francis Collins regarding ME/CFS. That letter was not enough, and we need your help now.

As you may know, ME/CFS is a complex disease with no known cause, treatment, diagnostic tool, nor cure. The CDC estimates that up to 2.5 million Americans suffer from ME/CFS, and patients have lower quality of life scores than those with lung cancer, stroke, and rheumatoid arthritis. According to the 2015 Institute of Medicine Report on ME/CFS, the disease costs the U.S. economy an estimated $17-$24 billion per year.

The National Institutes of Health (NIH) has not taken substantial action. When Director Collins responded to Congress, he wrote of an ME/CFS Interest group, a lecture series, and the promise of funding to come. Read more about Director Collins’s response here: http://solvecfs.org/wp-content/uploads/2016/11/SMCI-NIH-Response-Flaws-Flier.pdf.

And the NIH continues to disregard the legitimate needs of ME/CFS patients. On Wednesday, November 9, the NIH’s clinical center is scheduled to host a lecture given by Dr. Edward Shorter, a historian at the University of Toronto and one of the most controversial and inflammatory figures to the ME/CFS patient community. This man, despite overwhelming scientific evidence, does not believe ME/CFS is an actual disease—instead calling it a “psychic epidemic” perpetrated by “moaning and groaning victims” who are “delusional.” Dr. Shorter has written pieces so disparaging of patients that they were removed from circulation by Psychology Today.

The NIH is clearly not prioritizing a solution to ME/CFS when they provide a forum for a speaker who demeans patients and denies scientific findings. I am asking you to please stand with patients who are very ill with this very REAL physiological disease, as verified by thousands of published scientific articles.

Please contact NIH Director Francis Collins and ask him to

• Present scientifically grounded information to NIH researchers. If the NIH insists on including an inflammatory and controversial speaker who offers no scientific rigor, please balance this with an opposing expert such as Mary Dimmock, author of 30 Years of Disdain: How HHS and a Group of Psychiatrists Buried Myalgic Encephalomyelitis.
• Reaffirm the findings of the Institute of Medicine report that ME/CFS is a true physiological disease, not a psychological one.
• Prioritize ME/CFS funding with substantial investment commensurate with the burden of this devastating disease.

Only continued oversight from you and your colleagues in Congress will induce the NIH to take the actions necessary to help patients.

Very truly yours,

(NAME)

Step 3: Let us know how it went

E-mail our advocacy and engagement manager, Emily Taylor (etaylor@solvecfs.org), to let us know your member of Congress received the message.

Thank you for doing your part to advocate on behalf of all the patients who suffer with this disease.

Komaroff summary of 2016 IACFS/ME meeting

The IACFS/ME (International Association for CFS and ME) Conference is held every other year. This year it was held on October 27-30, at the Westin Fort Lauderdale Beach Resort in Fort Lauderdale, Florida.

This conference is a huge event, attracting researchers and clinicians from all over the world. There are workshops, presentations, poster sessions and numerous networking events. It is an exciting gathering, and a wonderful opportunity to hear the latest in ME/CFS research.

Traditionally, Dr. Komaroff gives a summary of the notable research presented at the conference. 

Mary Schweitzer has generously provided the summary below with this note: This is my best effort of transcribing Komaroff’s summary of the 2016 meeting - feel free to repost.

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Komaroff summary of 2016 IACFS/ME meeting

In the past two years, since the 2014 SF meeting the report of the IOM based on a review of other 9.000 published articles concludes that ME/CFS is a “biologically-based illness”

Announcement of expanded research activities by the National Institutes of Health and educational efforts by the Centers for Disease Control and Prevention.

Evidence from this meeting of a biologically-based illness:

Studies of:
- Post-exertional malaise
- Immunologic findings
- Microbiome studies
- Brain and nervous system studies
- Epigenetic studies
- Energy metabolism
- Miscellaneous
- Diagnosis and treatment

Studies of post-exertional malaise (PEM)

Detailed analysis of the components of “post-exertional malaise” (Stanford)
- Physical and cognitive exertion trigger PEM more often than emotional distress.
- PEM includes not only fatigue, but also cognitive difficulties, sleep disturbances, headaches, muscle pain and flu-like symptoms
- PEM lasts 3 or more days in approximately 25% of people.

Exercise testing in patients with ME?CFS vs. healthy controls:
- Triggers a characteristic gene expression “signature” involving 15 cytokines/adipokines/growth factors (Stanford)
- When repeated 24 hours after a first exercise test leads to a significant decline in peak heart rate (“chronotropic incompetence”), which could contribute to post-exertional malaise (U of the Pacific)
- Leads to postural tachycardia after exercise (as contrasted to after tilt table testing) in a subset of ME/CFS patients and Gulf War Illness patients, due to increased sympathetic activity (Georgetown)

Exercise testing in patients with ME/CFS vs. healthy control subjects:
- Leads to lower oxygen consumption and earlier conversion to anaerobic metabolism (Nova and Wisconsin)
- Blood lactate levels in 2nd exercise test after 24 hours
- ME/CFS patients lactate levels are higher at all work loads
- Healthy controls: lactate leels are lower at all work loads.

Immunology:

Huge study: 192 cases, 392 healthy controls.
- Levels of 17/51 cytokines/adipokines/growth factors were significantly different in ME/CFS than healthy controls
- Most of the cytokines were pro-inflammatory, and their levels correlated significantly with the severity of symptoms (Stanford University)

Interesting because many clinicians and researchers in this field have long believed that the disease was caused by abnormal cytokines in the brain.

The errant B cell:
- The early rituximab studies, indicating therapeutic benefit in some patients (Bergen, Norway)
- Reduced diversity and increased clonality of B cells in ME/CFS
(NCNP, Japan)


Microbiome;

How the Microbiome may affect the brain
- The human microbiome: 10 times as many bacterial cells as human cells, containing 5-8 million genes compared to our 20,000+ genes

Microbes in our gut:
- Synthesize hormones and neurotransmitters (e.g. norepinephrine, serotonin, dopamine, Ach, GABA)

- Synthesize molecules of inflammation (cytokines, prostaglandins) and elicit the production of those molecules by the gut immune system
- Through inflammation, create a “leaky gut”: the tight junctions that bind gut epithelia cells together become loosened – allowing bacteria and bacterial toxins to enter the blood.

In addition to the recently-reported reduction in bacterial diversity in ME/CFS, the team reports finding an increased number of Caudovirales bacteriophage viruses in ME/CFS.

All of these findings point to low-level inflammation in the gut. (Cornell)

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Brain and Nervous System

- Impaired speed in processing information is shown to be a critical deficit in both ME/CFS and Gulf War Illness
- Compared to healthy children, pediatric patients with ME/CFS had impaired information processing speed and attention. After exertion, these deficits worsened and ME/CFS kids also had poorer performance on tasks of working memory.
- Impairments in cerebral blood flow and cortical glutathione levels – not affected by comorbid psychiatric disease.
- A third of ME/CFS, but no healthy controls, had high white cell count or elevated protein in spinal fluid.
- Altered heart rate variability, due to reduced cardiac vagal activity, in ME/CFS v. healthy controls. [There is some evidence that this can be a sign or contributory factor to heart disease later.]

Functional connectivity among different brain regions impaired:
- Followed a cognitive test in ME/CFS v. healthy controls, determined by PET
- As determined by diffusion MRI in GWI patients
- As determined by EEG (eLORETTA) in ME/CFS patients at rest

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Epigenetic studies

- Disease is caused not just by mutated genes
- It also is caused by perfectly normal, non-mutated genes, when those genes are not “expressed” (turned on or off) appropriately
- Gene expression is controlled by many different “epigenetic” forces
- Epigenetic studies are increasingly being done in ME/CFS v. healthy control
- ME/CFS: genes involved in signal transduction are hypomethylated more often, whereas genes involved in cell differentiation/cell death are hypermethylated more often
- ME/CFS: significantly different gene expression patterns for genes, involved in immune regulation (JAK-STAT pathway), hormone regulation and mitochondrial dysfunction.
- Gulf War Illness: 19 related groups of genes (“functional modules”) were found to have significantly altered gene expression. Specific immunosuppressant and hormonal therapies were identified that might target these dysregulated genes, and possibly improve symptoms.
- ME/CFS patients, compared to healthy controls, have 13 different gene loci, all involving glucocorticoid sensitivity that are differentially methylated. The different methylation patterns correlated with clinical symptoms
- Characteristic expression of two particular microRNAs in plasma leads to elevated homocysteine levels identified in ME/CFS
- Three SNPs distinguished ME/CFS patients from healthy controls. All involve a gene that codes for a subunit of NADH dehydrogenase – an important energy molecule.
- MicroRNAs in spinal fluid predict orthostatic tachycardia after exercise.
- No clear gene expression differences in ME/CFS v. healthy controls, at rest.

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Energy Metabolism Studies

- Studies on patients in the rituximab trial have an energy metabolism deficit, and the key molecule is the enzyme pyruvate dehydrogenase (PDH). Speculate that autoantiboedies may be the cause of this deficit. Upregulation of PDH inhibitors in white blood cells (Norway group – study will finish late 2017)
- Peripheral white blood cells from ME/CFS produce energy less well than WBCs from healthy subjects, particularly when the cells are exposed to stressors.
- Citric acid cycle metabolites are depleted. Glucose as an energy source is being replaced by fatty acids and amino acids
- “Unbiased” metabolomics study finds that the metabolites that are most different between ME/CFS and healthy controls involve pathways harvesting energy from glucose, fatty acids and amino acids.
- Also finds a general hypometabolic state, as did the recent paper from Naviaux (PNAS), though different metabolites were examined.

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Miscellaneous

- ME/CFS patients, but not healthy controls, experience a worsening of symptoms following true (but not sham) strain: neuromuscular strain (even sitting/driving for prolonged time) may contribute to symptoms of ME/CFS. Physical therapy likely to help
- Five specific findings on physical examination were quite accurate in diagnosing ME/CFS. This is of interest, since ME/CFS is defined exclusively by symptoms.
- Of over 200 single-nucleotide polymorphisms examined, three – all located in the gene for NADH dehydrogenases – were significantly different in ME/CFS patients than in healthy controls.
- ME/CFS patients have significantly higher anti-citrullinated protein antibodies than matched healthy controls, as is seen in the autoimmune whatever.
- Particular mutations in two nucleosome transport genes distinguish ME/CFS patients from healthy controls.
- A second case of ME/CFS caused by an enteroviral infection of the brain.
- Impressive hypothesis: dysregulation in the production/release of Hydrogen Sulfide could explain many of the symptoms and objective abnormalities seen in ME/CFS
- A subset of ME/CFS patients with sinusitis and/or hives has more pain and other symptoms

Possible Diagnostic Tests for ME/CFS?

Four biomarkers – IL-8, sCD14, PGE2 and CD3/CD57+ count – correctly predicted ME/CFS in 97% of female cases (UNR)

An ideal diagnostic test would:
· Have very low false positive and false negative rates, compared to healthy controls and other fatiguing disease, when retested on a large number of new people
· Be easy for perform reliably by many labs
· Be inexpensive

Treatment Studies

· MRI spectroscopy revealed 15% lower levels of the natural antioxidant, glutathione, in the brain in ME/CFS patients compared to controls. N-acetyl-cysteine (NAC) treatment improved both brain
glutathione levels and symptoms, and reduced oxidative stress, in the ME/CFS patients
· Randomized trial of low-dose methylphenidate plus a nutritional regimen designed to improve mitochondrial function. At 12 weeks, a trend toward reduced symptom that was not statistically significant; more severely ill patients seemed to benefit
· A careful study of 990 ME/CFS patients found that patient beliefs about the cause of their illness did not explain their level of activity, a result that does not support the theoretical benefit of cognitive behavioral therapy.
· Multimodel physical therapy improves symptoms in adolescents and young adults with ME/CFS and impaired range of motion.
· Quantitative modeling identifies drug that are already FDA-approved and that might target TNA-alpha, IL-2 and the glucocorticoid receptor – targets that may be important in causing the symptoms of GWI

Multisite consortia to standardize and pool clinical and biosample data
· CDC: Multi-Site Clinic Assessment (MCAM), with 7 collaborating centers. Biospeci and other things.

Questions addressed by many presentations:
· In an illness defined exclusively by subjective symptoms, is there evidence of underlying biological abnormalities?
· Could those biological abnormalities theoretically explain the symptoms?
· Do the abnormalities in fact correlate with the symptoms?

In Summary:

Case-control studies comparing patients with CFS to both disease comparison groups and healthy control subjects find robust evidence of:
· the brain and autonomic nervous system
· immune system
· energy metabolism
· oxidative and nitrosative stress

The illness is not simply the expression of physical symptoms by people with a primary psychological disorder.

[Komaroff believes that new methods are getting us closer, quicker. Also the exercise evidence is changing the way people do research.]

Millions Missing Day of Protest Draws Attention to Plight of ME/CFS Patients All Over the Globe

This article was first published on ProHealth.

By Erica Verrillo

On September 27, ME Action sponsored the second Millions Missing global event. (The first was in May 2016.)

The purpose of the Millions Missing events was to draw public attention to ME/CFS, to demand increased funding into research for biomarkers and for effective treatment, and to improve medical education and patient care. (You can read the demands HERE.)

The global day of protest was a resounding success, with demonstrations in twenty-five cities in ten countries, and more being planned. The Millions Missing events drew ample media attention, as well as interest from government representatives and hundreds of passersby who saw the moving displays of empty shoes and stopped to talk to the volunteers – both patients and supporters – who dedicated their day to this worldwide effort.

I have selected some representative photos below, but to get the full impact of the event, I encourage you to browse ME Action's gallery of inspiring photos HERE.

Please donate to this admirable initiative! This is the first time that there has been a coordinated international movement to bring attention to this disease, and to raise awareness at such an impressive scale. Millions Missing deserves our whole-hearted support!

DONATE HERE.

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UNITED STATES

ATLANTA

In Atlanta, Georgia, a group gathered at the State Capitol to give speeches about personal tragedies, the history of ME/CFS and hopes for a new science leading to a brighter future. State Representative Michael Caldwell was present and several other Representatives and staffers stopped by to listen and learn.

BOSTON

Patients and supporters met in front of the JFK building to raise awareness for ME/CFS. They laid out shoes, handed out flyers, displayed posters, and chatted with passersby. A couple of patients did performance pieces!

CHICAGO

Over 70 patients gathered outside the James Thompson Center in Chicago. Carol Head spoke as a patient and the president of SolveME/CFS Initiate stating "we will no longer be ignored." She focused her speech on the Institute of Medicine's report. Leonard Jason spoke about the severity of the disease and Marcie Zinn described the brain research she is working on at DePaul University in Chicago.

Press: Chicago Residents To Protest Lack Of Support For Those Suffering With Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

DALLAS

Eight people attended the Millions Missing protest at Dallas City Hall Plaza. A 25-foot banner was displayed among posters and photos of patients who were unable to attend. The protest demands were read and posted on Facebook live.

LANSING

The Lansing #MillionsMissing protest was held on the East steps of the Michigan State Capitol building, and several local news crews were present. Nineteen attendees from all over Michigan held signs and sat on the steps under a large banner. Patients shared their stories, and there was a long moment of silence for those who have died and those who are bed-bound.

MORRISTOWN

In Morristown, NJ, the demonstration lasted from 3:30 - 8:30 PM. Many people stopped by to learn more about ME/CFS, as well as the lack of funding and support from the NIH, CDC and HHS. The patients who were able to stop by were very grateful for this initiative.

NEW YORK

The NYC protest had approximately forty people in attendance with a full agenda of speakers. Dr. Susan Levine, Dr. Mady Hornig, Jim Eigo (ACT UP/NY), Annette Gaudino (Treatment Action Group), ME Activist Terri L. Wilder as well as other people living with and affected by ME spoke at the demonstration. A few reporters showed up and at the end of the demonstration Terri and Annette attempted to deliver a "bad report card" to the HHS regional office director but were stopped by building security and threatened with a citation! (See pictures in NYC photo folder HERE.)

After tweeting "at" Jackie Cornell, HHS Regional 2 District Director, and asking her what she has done for New Yorkers with ME, ME Activist Terri Wilder received a private tweet from Ms Cornell stating "I'd love to sit down and discuss. I'm in DC a few days of this week and next but please email me and we can set up a time. Thank you for your advocacy and reaching out!"

Press: “More than a million Americans are suffering from a debilitating disease that makes simple tasks impossible — and they’re fed up with being ignored,” Business Insider

NORTHAMPTON

About a dozen patients and supporters gathered in front of City Hall in Northampton, MA. Passersby stopped to look at the display of shoes on the steps of City Hall, as well as read handouts and talk about ME/CFS with demonstrators. Lisa Hall, RN, from Northampton Wellness Associates gave a speech about the countless patients with ME/CFS she has seen, and described the severity of the disease. One patient spontaneously went into the town hall to invite the mayor to come down and visit. He did, and after speaking with the demonstrators offered a City Proclamation making May 12 official recognition day for ME/CFS.

Press: The local NBC station came and shot footage for a TV piece that ran on the evening news: http://wwlp.com/2016/09/27/millions-of-americans-suffer-from-chronic-fatigue-syndrome.

SAN FRANCISCO

Well over 100 people showed up for the Millions Missing day of action in San Francisco. Over 150 patient profiles were stretched across 120 feet and a 60-foot quilt made over 17 years ago was displayed. The quilt was a created in three countries as a desperate plea for visibility and funding.

Hundreds of individuals passed these displays, many of them stopping to look for several minutes and ask demonstrators about the illness. Patient Sonya Heller Irey gave a passionate speech about the devastation this disease can inflict on an individual. A proclamation provided by Mayor Ed Lee was announced, naming a day of Awareness for ME in San Francisco, and a certificate of honor was issued by the San Francisco board of supervisors in recognition of the advocacy of the Millions Missing campaign.

Groundbreaking ME/CFS researchers, Dr. Eric Gordon, Dr. Ron Davis, and Dr. Jose Montoya, attended this event. Dr. Eric Gordon talked about potentially having a biomarker in the near future based on the recent metabolomics study.

“CFS/ME has devastated the lives of millions of people worldwide. The pain, suffering and solitude that this disease has brought to so many human beings is immeasurable. For the past 35 years, CFS / ME patients have been ignored, humiliated, misdiagnosed, mistreated and told that the disease is the product of their imagination. As a clinician investigator at Stanford University, when I close my eyes and I see the disease in all its enormity and complexity, I can only conclude that this is likely one of the greatest medical and scientific detective stories we face in the 21st century,” said Jose Montoya, professor at the Stanford University Medical Center.

Dr. Ron Davis added. “Unfortunately this [protest] is really necessary…. NIH funding gives you a steady state level of funding for five years so you can plan and you can hire people and you can do a much more effective job of doing the research... it’s not about doing one study, it’s about a sustained effort to figure it out and that’s why we need government funding in this project.”

SEATTLE

Demonstrators handed out flyers and held up signs for about two hours while passersby stopped to talk. Those who stopped were saddened and surprised by the fact that many people get so ill they can no longer work at all and stay in bed most of the day. It was a wonderful opportunity to come together to spread awareness of this debilitating disease.

WASHINGTON, D.C.

A large protest was held at the U.S. Department of Health and Human Services in Washington. Speakers included Ryan Prior and Hillary Johnson. Laura Benson and her husband, a retired Air Force officer, also gave compelling speeches. Three journalists covered the event, and the Montgomery County Council (home of NIH) issued a proclamation supporting ME/CFS awareness day.

Press: #Millionsmissing ME/CFS Protest in Washington, D.C.,” Inspire
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CANADA

TORONTO, CANADA

A protest was held at the Health Canada Regional Office at 180 Queen St West, Toronto on October 6, from 12 - 2PM. ME/CFS specialist Dr. Alison Bested attended the event.

You can find more information here: https://www.facebook.com/events/1120173071406359/?active_tab=posts

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UNITED KINGDOM

LONDON

“The day was in equal measures surreal, empowering, saddening and desperately emotional. The sense of brotherhood felt almost palpable as we stood together and spoke about our experiences with ME – our personal struggles, our deepening concern over graded exercise trials, particularly in children, and how one mother now cares for her husband and two children, all of whom suffer from ME.

We were grateful to have been live a total at least three, perhaps even four times throughout the protest thanks to London Live News (footage to follow) as well as grasp the attention of hundreds of passers-by with our strong words, our prominent display of shoes, and of course, our naked protester holding up the sign, You can’t ignore ME now.”

PRESS: “Striking protest about ignored ME sufferers outside the Department of Health in London today #MillionsMissing” (Christopher Hope, Assistant Editor and Chief Political Correspondent, The Daily Telegraph, on Twitter)https://twitter.com/christopherhope/status/780725734432247808

BELFAST

Dozens of shoes were laid out at Stormont, the seat of the Northern Ireland Assembly. Twenty-seven protestors held signs, including Sally Burch, long-time patient and Trustee of Hope 4 ME and Fibro. According to the Telegraph, Ulster Unionist health spokeswoman Jo-Anne Dobson MLA hosted the campaign. She said: "The sheer passion and drive of campaigners on display today at Stormont must be met by real and positive change in the treatment of thousands of patients across Northern Ireland."

Press: “Demonstrators at Stormont urge more research into chronic disease ME,” The Irish News, 28 September 2016

“ME sufferers step up drive for more help,” Belfast Telegraph, 28 September 2017

BRISTOL

Bristol displayed 150 shoes on College Green in central Bristol, for a day of protest on behalf of the Millions Missing. ME patients, loved ones and family members gave out leaflets and talked to passersby, most of whom were visibly shocked to learn the truth about this devastating illness. One individual stayed for almost an hour reading every single label on every pair of shoes. Many wanted to donate to fund research.

Press: BBC Radio Bristol (at 2hrs 11mins):http://www.bbc.co.uk/programmes/p046wd9k

Bristol Post: 100 pairs of shoes used to make poignant protest on ME research in Bristol city centre

CARDIFF

The Millions Missing event in Cardiff was held on the steps of the Welsh Assembly that looks out over Cardiff Bay. Rows of empty shoes were a very poignant reminder of what the demonstration was all about. The Cardiff Rock Choir volunteered their services free of charge and drew the attention of passersby. A dance trio also performed, adding to the day.

A number of Assembly Members came out to speak with the demonstrators, including Julie Morgan who sponsored the group. Jan Hutt Assembly Member for the Vale of Glamorgan also came out onto the steps of the Assembly to speak to the demonstrators. Other Assembly Members stopped to find out more about Millions Missing, including Vikki Howells AM for Cynon Valley, David Melding AM for South Wales Central, and Dai Lloyd AM for South Wales West.

Press: Made in Cardiff TV came to film the event and presented a good report at 6 pm and 9 pm on their Tuesday evening News.

NOTTINGHAM

About 15 patients, family and friends gave out 200 flyers, spoke to 300 people, and got 30 signatures to stop GET trials on children. A passing ME patient couldn't believe that someone was standing up for ME "as people never do anything for us."

Press: BBC Nottingham Radio, covered on news bulletins throughout the day and had a 10-minute segment (about 5:20) as part of drive show (prime driving home from work time)

BBC East Midlands Today covered the demonstration on local TV news on the evening news segment. They filmed at the event and at a patient’s home.

OXFORD

The Oxford event took place in front of the Radcliffe Camera Landmark. Over 100 pairs of shoes were laid out. Volunteers helped to hand out around 200 leaflets and explained ME to curious passersby, many of whom stopped to read the shoe tags describing each sufferer's experience with ME.

Press: BBC Radio Oxford

BBC South Today

Oxford Times

Oxford Mail

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CONTINENTAL EUROPE

HAMBURG, GERMANY

Patients and relatives met at the Hamburg harbor to raise awareness of ME/CFS. People came from all parts of the country and there was huge virtual support.

“ME/CFS must be considered as a severe physical illness. It’s time to take us seriously!” said Daniel from the German Society of ME/CFS. Nicole from the Lost Voices Foundation pointed out that “Patients are left alone! This day is so important for us to raise awareness of ME and to eventually improve overall care and treatment.”

THE HAGUE, NETHERLANDS

A Millions Missing protest was held from 10:00 AM to 4:00 PM in front of Parliament in The Hague. About 1000 pairs of shoes were displayed, which drew the attention of many visitors. Fifteen demonstrators handed people flyers and talked with them about ME. Dr. Frans Visser gave a speech. The group spoke to two members of Parliament from two different political parties.

Press: ME Patients Display Thousands of Shoes on the Square

Omroep West: ME patients demonstrate in The Hague Square

De Telegraaf: Silent shoes parade before Lower House

Radio 1 interview with Carolien van Leijen: ME patients want more understanding, not comments like "get a dog"

Read more about Dutch press coverage HERE.

OSLO, NORWAY

Demonstrators in Oslo displayed 250 pairs of shoes and spoke with 300 passersby. Olaug V. Bollestad, a member of Parliament, and two speakers from patient organizations gave speeches. Three musicians performed. One patient group brought fruit and yoghurt for the participants to tide them through the event. The participants intend to start a collaboration with the Norwegian research fundraising group to help fundraise for clinical studies here in Norway.

Press: The demonstrators were interviewed by a national radio station at 3pm and filmed all day by a documentary filmmaker who is creating a documentary about ME and the Rituximab study in Norway. The film will come out in 2018. The event was filmed live and had about 120 people watching the live feed.

“ME: – De meldes til barnevernet for omsorgssvikt,” Side Two, Sept. 27 2016

Additional links:https://www.facebook.com/elisabeth.royseth/posts/10153863829561680

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VIRTUAL

SOUTH AFRICA

The recently formed ME/CFS Foundation South Africa held a virtual event. They asked patients for their stories and photos of shoes/activities they could no longer participate in, made posters, and posted these throughout the day on Facebook, posted on Twitter, sent the virtual event to numerous online newspapers. They also texted and emailed radio presenters throughout the day.

Press: Shoes for a Syndrome

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MELBOURNE, AUSTRALIA

#MillionsMissingMelbourne will be held on 12 October at Victorian Parliament

55 Members of Congress Sign Letter Supporting Biomedical Research for ME/CFS

After dogged work by advocates, fifty-five members of Congress have added their signatures to a letter initiated by representatives Zoe Lofgren (D - CA) and Anna Eshoo (D - CA).

The letter urges NIH to respond in a timely fashion to requests for grants. It also asks NIH to report its efforts to fund research as well as the status of specific plans for funding over the next two years.

Congressional support is crucial for obtaining funding for research because unlike agencies, which are beyond our influence, representatives have an obligation to support the interests of their constituents.
____________________

SCMI Press Release:

Advocates Obtain Congressional Support for Strengthened ME/CFS Research at NIH

LOS ANGELES, September 9, 2016 – After years of neglect by the National Institutes of Health (NIH), patients suffering from myalgic encephalomyelitis (ME), commonly known as chronic fatigue syndrome (CFS), created a win today as members of Congress came together urging the NIH to do the right thing and strengthen ME/CFS research.

In a formal U.S. House of Representatives letter published today (“the letter”), 55 members of Congress called upon NIH Director Francis Collins to strengthen the NIH’s efforts in ME/CFS biomedical research through a reinvigorated trans-NIH ME/CFS working group as well as additional intramural and extramural research programs.

As the letter explains, “ME/CFS is a complex, debilitating, and chronic disease afflicting 1 to 2.5 million Americans. It costs individuals, the U.S. health care system, and our economy an estimated $17-$24 billion annually. Yet, as the Institute of Medicine noted in its report, ‘Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness,’ there has been ‘remarkably little research funding’ to date to discover its cause or possible treatments.”

Thanks to the hard work of #MEAction, the Solve ME/CFS Initiative (SMCI), and dozens of independent advocates, the letter attracted a broad coalition of bipartisan cosigners led by U.S. Representatives Zoe Lofgren and Anna Eshoo of California. In addition to encouraging advocates all across the country to reach out to their own representatives, SMCI President Carol Head also wrote a personal letter to all 435 representatives, urging them to sign onto the letter.

Said SMCI President Carol Head, “The NIH has failed to live up to its commitment to ME/CFS patients and has not followed the recommendations put forth in the 2015 IOM report; now, thanks to the actions of a coalition of hardworking advocates and members of Congress, we expect this to change.”

To read the letter and see the 55 members of Congress who signed on, view the letter here.

About the Solve ME/CFS Initiative (SMCI)

The Solve ME/CFS Initiative (SMCI) was founded in 1987 and has established itself as the leading non-profit organization dedicated to ME/CFS. The organization’s mission is to make ME/CFS widely understood, diagnosable, and treatable by stimulating and conducting research aimed at the early detection, objective diagnosis, and effective treatment of ME/CFS. SMCI is the first and only ME/CFS organization to earn the highest possible distinction (a 4-star rating) from Charity Navigator, America’s largest independent charity evaluator.

September 9, 2016

Tribunal Orders Release of PACE Trial Data: Is This the End of an Error?

On August 16, the First Tier Tribunal (UK) ordered the release of the PACE Trial data to Alem Matthees, marking the end of a two-year battle. (You can read the order HERE.)

Mr. Matthees is an Australian researcher, and ME/CFS patient, who has made repeated attempts under the Freedom of Information Act to obtain anonymized data from the PACE trial. Queen Mary University of Londom (QMUL) has managed to quash every request - until now.

In this historic ruling, the tribunal determined that:

1) The information Mr. Matthees requested is not personal, and therefore an exemption based on the possibility that people in the trial could be identified does not apply.

2) Because data are anonymized, invasion of privacy does not apply.

3) There is no indication that the release of anonymized data would discourage future research.

4) There is a strong public interest in releasing the data.

This last point is especially important, as it directly addresses the issue of transparency in research, a topic that has been much in the news lately.

In a 2005 article published in PLoS ONE, Stanford professor John Ionnides claimed that most published research findings were false. There are a number of reasons why research is falsified, including outright plagiarism, conflict of interests (especially true in cases where research is being paid for by pharmaceutical companies), poor methodology, scientific malfeasance, false premises, and general incompetence.

In the case of the PACE trial, conflict of interests led directly to scientific malfeasance. The conflict here stemmed from the unwillingness of NHS to pay for treatment for ME patients. In comparison to treatments such as Ampligen, IVIG, and other immunotherapies, cognitive behavior therapy (CBT) and graded exercise (GET) are relatively cheap to administer.

The PACE trial is not the first trial to make the claim that CBT and GET are beneficial for ME/CFS patients. Trudie Chalder, one of the principals in the PACE study, has been publishing articles since 1989 touting the benefits of CBT and exercise for ME/CFS patients. Nor is she a stranger to faulty methodology as the statistics on some of these studies were questionable.

The PACE trial was the crowning glory to over two decades of research for Chalder, as well as for several other psychiatrists involved in the study. While it is unlikely QMUL will spend any more money on challenging the tribunal's decision, it is equally unlikely that the PACE trial group will abandon its "research" into CBT and GET. In fact, a second PACE study involving adolescents is already under way.

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Press Release from ME Action:

Thursday, 18th August 2016, London, UK - A tribunal has ruled that data from a treatment trial into
Chronic Fatigue Syndrome (CFS) must be released, rejecting an appeal from Queen Mary University
of London (QMUL).

PACE was a £5 million, publicly-funded clinical trial of exercise and cognitive behavioural therapy for CFS. It has been highly influential in determining treatment in the UK and abroad, but has been
controversial. Academics and patients have both voiced concerns over “misleading” claims. Dr
Richard Smith, former editor of the British Medical Journal, said in December 2015 of QMUL’s failure to release the data, “…the inevitable conclusion is that they have something to hide”.

QMUL spent over £200,000 on legal fees in this case, to appeal the Information Commissioner’s
decision that they should release anonymised data from the trial. The request for data was made
under the Freedom of Information Act by Mr Alem Matthees, to allow analysis of the data according
to the study’s original published protocol.

QMUL made several arguments why the data should not be released, their main claims being that
the data was personally identifiable information, and was not sufficiently anonymised. However, the
tribunal rejected these arguments, noting that QMUL had already shared the data with a small
selection of other scientists, stating, "In our view, they are tacitly acknowledging that anonymization
is effective, or else they would be in breach of the consent agreement and the DPA principles."

The tribunal was satisfied that the data “...has been anonymised to the extent that the risk of
identification is remote.” The tribunal also noted the "strong public interest in releasing the data
given the continued academic interest" and "the seeming reluctance for Queen Mary University to
engage with other academics they thought were seeking to challenge their findings."

In his correspondence with the court, Mr Matthees expressed “concerns that QMUL are restricting
the registered researchers to whom they disclose the data upon request.” The tribunal said, “The
evidence before us is not clear but if QMUL are cherry-picking who analyses their data from within
the recognised scientific research sphere to only sympathetic researchers, there could be legitimate
concerns that they wish to suppress criticism and proper scrutiny of their trial.”

In its submissions QMUL made a number of accusations of harassment from patients, while QMUL’s
expert witness characterized PACE trial critics as "young men, borderline sociopathic or
psychopathic", remarks the Information Commissioner dismissed as "wild speculations".

When pushed to provide evidence of these threats and harassment under cross examination,
witnesses speaking for QMUL were unable to do so, and ultimately conceded that "no threats have
been made either to researchers or participants."

The tribunal found QMUL's assessment of activist behaviour to be, “grossly exaggerated” stating
that “the only actual evidence was that an individual at a seminar had heckled Professor Chalder.”
[Professor Chalder is a leading researcher in the PACE trial and a key witness for QMUL.]

Expert reaction to the decision

Jonathan C.W. Edwards, MD
Emeritus Professor of Medicine
University College London

“I think this is the right decision and I congratulate Mr Matthees on persevering with a very
reasonable request. The report indicates that the Tribunal considered arguments from both sides
very thoroughly. It has become clear that the reasons given for not providing the information
requested are essentially groundless. It is also clearly appreciated that critics of the PACE trial are
not young sociopaths - they include senior medical scientists like myself, concerned about poor
science!”

Bruce Levin, PhD
Professor and Past Chair
Department of Biostatistics
Columbia University
Mailman School of Public Health
722 West 168th Street
MSPH Box 12, Room 647
New York, NY 10032

“I am heartened by the Tribunal’s finding that the Commissioner had reached a correct decision in
ordering release of anonymized data for the PACE trial. The Tribunal’s assessment that the
perceived risks of data release were neither substantiated nor demonstrated in the evidence before
them and that such minimum risk as had been expressed to them would not in their view outweigh
the public interest in disclosure of the disputed information is quite important, not only for patients
in this trial and around the world, but also because it underscores how essential transparency and
open, critical review of clinical trials are to the scientific method.”

Keith Geraghty, PhD
Honorary Research Fellow
University of Manchester

"I read the tribunal decision with great interest. I was surprised that the PACE authors declared in
evidence that they had shared their trial data with other researchers. I contacted lead author Prof.
Peter White to request access to PACE data to run an independent analysis, but my request was first
ignored, then later refused. I now understand that the authors shared the data with a select few
academics who they picked to co-write papers, but they have failed to share the data with the
broader scientific community. Selectively sharing this publicly-funded data with collaborators but
refusing to share data with anyone else, is not in the best interests of patients or science, and it
creates a perception that the PACE team do not want independent critical analysis of this trial. I find
it regrettable that the Medical Research Council, who partly funded this very expensive study, did
not specify that the trial data be made available to other researchers.”

Dr Charles Shepherd
Hon Medical Advisor, ME Association

“The tribunal decision to firmly reject the QMUL case for not releasing anonymised PACE trial data
will be widely welcomed by the ME/CFS patient community.

This means that there can now be an independent analysis of data from the PACE trial that has been
used to support a number of conclusions and recommendations regarding the benefits of CBT and
GET in ME/CFS that are just not consistent with patient evidence for these interventions
Having attended the hearing, where a number of unsubstantiated and serious accusations were
made against the patient community, I am pleased to see that this 'red herring' was also rejected by
the tribunal. I hope that QMUL will now accept this judgement to release the data and do so without further delay and that they will not spend any more public money on an appeal.”

David Tuller, DrPH, Investigative journalist and public health expert
University of California, Berkeley

"This decision is a thorough repudiation of the efforts by the PACE investigators to protect their
claims and findings from being exposed as utter nonsense. You don't actually need the data to
determine that the trial is a piece of garbage, but having the data at last will make it clear to
everyone. They will likely appeal, but they will ultimately lose."

Alem Matthees
Patient and Second Respondent
Australia

I am very pleased with this outcome. Both the Tribunal’s decision and commentary are a long
overdue victory for the patient community, as well as for advocates of clinical trial transparency and
open data sharing. I want to thank everyone who gave support, advice or assistance, as well as
anyone who engaged in debate over the PACE trial and the sharing of clinical trial data. This case
ended up costing me greatly in time, energy, and health (currently bedridden).

I utilised the FOIA to loosen the vice grip control over the data and allow truly independent and open
analyses that do not rely on the approval of QMUL or the PACE trial investigators. All this came
about largely because of their refusal to publish or release the protocol-specified outcomes, and
their generally questionable and poorly or erroneously justified changes to the published trial
protocol, i.e. outcome switching, after the trial was over and/or after seeing trial data. Claims of
clinically significant improvement may be open to interpretation, but false or misleading claims of
recovery or remission from debilitating illness simply have no place in the scientific literature.

Tom Kindlon
Information Officer
Irish ME/CFS Association

I hope Queen Mary University of London won't appeal again and cause more public money and
resources to be spent on the case. Now that a court has ruled that the data is non-identifiable and
that releasing it will not contravene agreements with trial participants, there is no good reason to
continue to withhold it. If QMUL appeal, people may suspect this case was at least partly about
trying to hide inconvenient results. Indeed, the tribunal decision notice itself raised the question of
whether QMUL may wish to avoid proper scrutiny of their trial.

Patients want nothing more than to recover from this condition, so misleading claims about recovery
rates are a particularly serious matter. Many are very sceptical of suggestions they can recover with
talk therapy or by steadily increasing their levels of exercise. This is not their experience.

Extraordinary claims require extraordinary evidence but the researchers have not yet released such
evidence: they revised all four aspects of the recovery criteria to make it much, much easier to be
classed as recovered and have so far failed to provide valid justifications for these changes. Some of
the PACE Trial investigators have conflicts of interest, such as doing work for insurance companies,
which can make people concerned about bias.

This is a huge victory for patients, who have a right to examine the evidence for the treatments that
affect their lives. I expect that the recovery rate will only be a small fraction of what the PACE
researchers claimed, due to the dramatic changes they made to the criteria.

Jane Colby
Tymes Trust Executive Director

"Tymes Trust is pleased at the judge's ruling. We believe that, pending independent analysis of PACE
data, the MAGENTA (PACEstyle) study in children should be suspended immediately."

Leonard A. Jason, PhD
Professor of Psychology and Director
Center for Community Research
DePaul University
990 W. Fullerton Ave.
Suite 3100
Chicago, Il. 60614

“I believe that an independent analysis of the controversial trial would be in the best interest of
scientists, clinicians and patients.”