Saturday, July 9, 2016

It's All in Your Gut

A study out of Cornell University made the news recently when Maureen Hanson's team found distinct alterations in the gut flora of patients with ME/CFS. The headlines trumpeted the "first" biological marker for the disease in the microbiome.

Those of us who have kept track of the research know that this is not a "first." De Meirleir, Maes, Lemle, as well as Dunstan, and Butt in Australia have all published papers documenting alterations in gut flora in patients with ME/CFS (not to mention Lipkin and Hornig's huge Microbe Discovery Project). Those alterations laid the groundwork for Butt's successful treatment of ME with fecal transplants in the late 90s.

The question that needs to be asked is whether these alterations are the cause or the result of the disease. Every disease produces alterations in gut flora - diabetes, Crohn's, heart disease, HIV, and cancer are among them, as well as all infections. (For a good paper on this topic go HERE.) The gut, which is the seat of your immune system, responds instantly to pathogens. It even changes in accord with what you are eating withing a few hours.

But rather than chicken or egg, these gut changes could be chicken and egg. For example, the pathogen that causes ME results in changes to the microbiome, then subsequent chronicity due to an altered immune system results in a perpetuation of microbiome changes. These, in turn, lead to more chronicity as commensal bacteria enter the bloodstream.

It's a good model, even if it doesn't identify the original culprit that started this chain of events.

You can read the full study HERE.

____________________________


Key to chronic fatigue syndrome is in your gut, not head

By Melissa Osgood, Cornell University

Physicians have been mystified by chronic fatigue syndrome, a condition where normal exertion leads to debilitating fatigue that isn't alleviated by rest. There are no known triggers, and diagnosis requires lengthy tests administered by an expert.

Now, for the first time, Cornell University researchers report they have identified biological markers of the disease in gut bacteria and inflammatory microbial agents in the blood.

In a study published June 23 in the journal Microbiome, the team describes how they correctly diagnosed myalgic encephalomyeletis/chronic fatigue syndrome (ME/CFS) in 83 percent of patients through stool samples and blood work, offering a noninvasive diagnosis and a step toward understanding the cause of the disease.

"Our work demonstrates that the gut bacterial microbiome in chronic fatigue syndrome patients isn't normal, perhaps leading to gastrointestinal and inflammatory symptoms in victims of the disease," said Maureen Hanson, the Liberty Hyde Bailey Professor in the Department of Molecular Biology and Genetics at Cornell and the paper's senior author. "Furthermore, our detection of a biological abnormality provides further evidence against the ridiculous concept that the disease is psychological in origin."

"In the future, we could see this technique as a complement to other noninvasive diagnoses, but if we have a better idea of what is going on with these gut microbes and patients, maybe clinicians could consider changing diets, using prebiotics such as dietary fibers or probiotics to help treat the disease," said Ludovic Giloteaux, a postdoctoral researcher and first author of the study.

In the study, Ithaca campus researchers collaborated with Dr. Susan Levine, an ME/CFS specialist in New York City, who recruited 48 people diagnosed with ME/CFS and 39 healthy controls to provide stool and blood samples.

The researchers sequenced regions of microbial DNA from the stool samples to identify different types of bacteria. Overall, the diversity of types of bacteria was greatly reduced and there were fewer bacterial species known to be anti-inflammatory in ME/CFS patients compared with healthy people, an observation also seen in people with Crohn's disease and ulcerative colitis.

At the same time, the researchers discovered specific markers of inflammation in the blood, likely due to a leaky gut from intestinal problems that allow bacteria to enter the blood, Giloteaux said.

Bacteria in the blood will trigger an immune response, which could worsen symptoms.

The researchers have no evidence to distinguish whether the altered gut microbiome is a cause or a whether it is a consequence of disease, Giloteaux added.

In the future, the research team will look for evidence of viruses and fungi in the gut, to see whether one of these or an association of these along with bacteria may be causing or contributing to the illness.

Journal Reference: Ludovic Giloteaux, Julia K. Goodrich, William A. Walters, Susan M. Levine, Ruth E. Ley, Maureen R. Hanson. Reduced diversity and altered composition of the gut microbiome in individuals with myalgic encephalomyelitis/chronic fatigue syndrome. Microbiome, 2016; 4 (1) DOI: 10.1186/s40168-016-0171-4


Friday, June 17, 2016

Chasing Competent Care Conference Report


By Sally Burch

Hope 4 ME & Fibro Northern Ireland ran an ambitious and exciting conference on Monday 6th June in The Stormont Hotel, Belfast.  The conference, “Chasing Competent Care” delivered a strong message calling for change to the currently inadequate care situation for ME and fibromyalgia patients in Northern Ireland.

Chairperson, Martina Marks opened the meeting, welcomed everyone and thanked the Big Lottery Fund for their sponsorship of the event. Her welcome was followed by an impassioned plea from Joan McParland, the founder and treasurer of Hope 4 ME & Fibro NI, to have medical professionals take patients’ symptoms seriously.  Joan explained that she had been ill, and operating at less than 30% of her normal capacity, since 1999. In that time no effective treatments had been offered, and one consultant had even suggested she was simply reading too much into her symptoms and that she should see a psychiatrist!

Joan thanked the many volunteers and family members who made the event possible, and also the medical professionals and MLAs in the audience for taking time to attend.

Sally Burch, another charity trustee, then pointed out that ME (myalgic encephalomyelitis) and fibromyalgia are both disorders recognised by the World Health Organisation. She then explained that the most severely affected by ME could be left bed-bound, tube fed and lying in darkened rooms for weeks, months and years! She further described the severely debilitating nature of fibromyalgia and how the invisible pain that sufferers endure can have devastating life consequences. Sally outlined the symptom overlap between these conditions and suggested that biomarker development and medical research was now urgently required.

Lined up, to the side of the speakers’ podium, was a haunting display of over 200 pairs of empty shoes. These were part of the global #MillionsMissing campaign. Each pair of shoes carried a tag with the name of a patient unable to participate in their active lives due to ME and/or fibromyalgia.  During the conference many attendees took time to read the comments on the tags and to consider the magnitude of the devastation caused by these largely forgotten and ignored conditions.

Joe McVeigh
First speaker up was Dr. Joe McVeigh, who outlined the problems with exercise and fibromyalgia. He explained that whilst exercise is important for maintaining health, that it must be conducted at a level manageable for each individual patient. He called this the “Goldilocks approach”, and explained that at no time should attempted exercise cause a patient to relapse.

Professor Malcolm Hooper next gave a strong talk berating the inadequacies and misleading conclusions of the PACE Trial.  At one point, he suggested that the PACE Trial was potentially fraudulent and told us that he had once even said as much in The House of Lords.  This elicited a spontaneous round of applause from the audience. Feelings run high amongst patients on the PACE trial, mostly because it has been used to support the NHS recommended therapies of Cognitive Behaviour Therapy (CBT) and Graded Exercise Therapy (GET), both of which have been demonstrated to cause harm in patient surveys.

Malcolm Hooper
Professor Hooper questioned the motives of the PACE trial authors in promoting results that carry such marginal benefits and such great potential risks. He recommended that patients reference Mark Vink’s paper, “The PACE Trial Invalidates the Use of Cognitive Behavioral andGraded Exercise Therapy in Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome:A Review,” any time they were asked to undertake these therapies.

After this lively and well received talk, the conference paused for a comfort break. The weather was uncharacteristically balmy for Northern Ireland, and some of the audience sat outside in the evening sun as they contemplated the issues raised.

Natalie Boulton, carer to her daughter who has severe ME, spoke next.  She opened by showing a clip from the video “Voices from the Shadows”, that gave the audience a disturbing insight into the annihilation caused by very severe ME.  Natalie told us she had recently followed up with some of the patients from the video and found many of them had worsened, and that both Emily Collingridge and Lyn Gilderdale had since died. She spoke of the horror of the treatments doled out by psychiatrists who believed patients to be faking their illness. Hers was a genuinely moving and sobering talk.

Next Professor Mady Hornig from Columbia University, USA, gave a detailed and highly informative account of her work towards developing blood biomarkers.  She explained how immunity and gut microbiota can be linked to the brain, its functioning and mood.  She talked about the epigenetic changes that can occur in the microbiome during a person’s lifetime and the link to serotonin production. She also talked about measuring blood molecules such as cytokines before and after an exercise challenge in ME patients, and comparing these changes to healthy controls. These cytokines being the most promising as potential biomarkers. Although much of what she described cannot be simply summarised, the audience was left with a strong feeling that Professor Hornig is now working determinedly to solve the biochemical riddles produced by ME.

Pamela Bell
Dr. Pamela Bell then took the podium to talk about the problem with pain. Dr. Bell has worked extensively in the field of pain, and is now chair of the Pain Alliance Northern Ireland. She emphasised the widespread nature of chronic pain and its disabling effects, noting that once pain becomes chronic it no longer serves a useful purpose in the body. She recognised the difficulties with effectively treating ongoing pain and explained that different types of pain needed different drug types to alleviate symptoms.

The final speaker of the evening was Louise Skelly from the Patient and Client Council of Northern Ireland.  She spoke of her frustration at trying to bring about change to the current impasse with Health and Social Care Board in Northern Ireland regarding the care on offer for ME and fibromyalgia patients. She spoke of her determination to follow through with the campaign to improve the situation, and of the great need of these neglected patient cohorts.

Martina Marks then brought the conference to a close. Overall the atmosphere of the evening was one of both frustration, and of optimism. Frustration that change seems to be taking so long to happen and for the injustices that have occurred along the way, but also optimism that things are starting gain momentum towards real medical advances for the future.

As the hall emptied, the lines of lonely shoes from the #MillionsMissing campaign were gathered up, their labels still attached, and some-one was heard to say: “These are the folk we do all this for, they will not be left forgotten any longer.”

____________________

Please consider using this link for all your online shopping and raise funds for Hope 4 ME & Fibro Northern Ireland at NO charge to you!

Friday, June 3, 2016

#MillionsMissing: A Day of Global Protest


This post was originally published on ProHealth.

By Erica Verrillo
 
On May 25, 2016, protesters all around the globe gathered to demand greater recognition and research funding for ME/CFS. Simultaneous protests were held in Melbourne, Australia; London, England; Belfast, Ireland, Ottawa, Canada; and in Boston, Washington, DC, Seattle, San Francisco, Dallas, Raleigh, Atlanta. and Philadelphia in the U.S. It was the largest protest ever held for this disease, involving thousands of participants worldwide.
 
The Millions Missing protest was organized by MEAction and coordinated by a group of dedicated advocates in order to highlight the long neglect of patients with ME and CFS. Millions missing represents the missing millions of dollars of research funding that should have been spent to find a cause and a cure. Millions missing also represents the millions of people who are missing their careers, their families, their friends, and their lives due to the ravages of a disease that can disable a sufferer for decades.
 
In most of these demonstrations, a display of shoes, sometimes in the hundreds, was laid out to symbolize missing patients who, due to illness, could not protest in person. Virtual demonstrations – pictures of shoes placed in driveways, on doorsteps, and on walkways accompanied by personal notes– were held in tandem. The virtual protest generated over 10,000 tweets with the hashtag #MillionsMissing as well as thousands of posts on Facebook.
 
Local organizers took advantage of this event to schedule meetings with HHS officials as well as their representatives. Jennifer Brea, founder of #MEAction, met with Senator Cory Booker's staff (Dem NJ), and patient advocate Sonya Heller Iray met with Senator John McCain (Rep AZ) and his staff for an hour.

To view photos from the #MillionsMissing protests around the world, go here.

The #MillionsMissing protest list of demands can be found here.

For #MillionsMissing in the news go here
 

SAN FRANCISCO

 
 
More than one hundred people gathered in front of the Federal Building in San Francisco. Carol Head, CEO of Solve ME/CFS Initiative, exhorted the federal government to live up to its promises. “We're all here today, because it's time for our government to increase funding and support for this disease,” she said. Ron Davis, scientific director of Open Medicine Foundation, talked about the research he is doing. “We are very close to finding a biomarker,” he said. “We do NOT want to wait another thirty years.” And as his wife, Janet Dafoe, spoke about their severely ill son, Whitney, the crowd chanted “Whitney ... Whitney ... Whitney...”  bringing tears to her eyes.


BOSTON





In Boston, demonstrators assembled at the JFK Federal Building. They handed out information and gathered signatures on a petition to support more funding for ME/CFS. Members of the group met separately with senior officials from the Boston branch of Health & Human Services to ask for their support. Charmian Proskauer, President of the Mass CFIDS/ME and FM Association was upbeat about the meeting. “They were very well informed, understood our issues, and asked great questions. We see this as the beginning of an on-going relationship,” she said.

SEATTLE



ATLANTA


 

MELBOURNE, AUSTRALIA



In Melbourne, hundreds of shoes were placed on the lawn in front of the Victoria State Library. (Photo credit: Karyn Adams)

LONDON, ENGLAND



In London, demonstrators held a silent protest at the Department of Health. Many stretched duct tape across their mouths to symbolize government neglect of ME/CFS patients. Ollie Cornes, a former software engineer, said, “The treatments the NHS provides are so ineffective as to be a waste of time and can be very harmful, which is why we are protesting at the Deptartment of Health.” Like so many other patients, Cornes was unable to attend the demonstration in person. He was represented by a pair of red baseball shoes.

Thursday, May 12, 2016

This Is It! May 12th International ME/CFS Awareness Day!

A version of this post first appeared on ProHealth.

By Erica Verrillo

International ME/CFS Awareness Day was originated by Tom Hennessy, an ME patient and staunch advocate who testified at numerous national and international ME/CFS conferences and meetings. Tom chose May 12th as ME/CFS Awareness Day to commemorate the birth of the famous nurse, Florence Nightingale, who suffered from an ME/CFS-like illness. May 12 is also International Nurses Day.

Over the years May 12 has been expanded to include other neuro-immune illnesses that share many of the features of ME/CFS. At present May 12 includes Fibromyalgia (FM), Lyme disease, and Multiple Chemical Sensitivity (MCS). All of these illnesses employ May 12 as an opportunity to raise public awareness, to contact representatives for more research, and to promote fund-raising activities.

Although it is not formally recognized in the US, International ME/CFS and FM Awareness Day is observed worldwide.

Simple things you can do:
  • Wear a blue ribbon for ME/CFS, a purple ribbon for FM, or a green ribbon for Lyme disease and MCS.
  • Tweet on May 12. Add #may12th to your tweet.
  • If you have a blog or a Facebook page, post something. It can be as simple as an awareness image.
  • If you have some spare cash, donate to research efforts. Open Medicine Foundation is raising money for their End ME/CFS Project.

INTERNATIONAL

Light Up the Night Challenge. “The challenge is to get as many buildings as possible in your country to light up with one of the 3 colours used on May 12th – blue (ME/CFS), purple (FM) or green (Lyme and MCS). We want public buildings/places like City Halls, Niagara Falls and we want individual homes lit up too!” See the Facebook page HERE.

#May12BlogBomb is back! May 12th is Awareness Day for ME, Fibromyalgia, Lyme Disease, Chronic Fatigue Syndrome and Multiple Chemical Sensitivity. Every year bloggers use this opportunity to express their views and to raise the profile of these much misunderstood and often maligned conditions. Blog bomb information is HERE.

Google – Create a Doodle. Every year the doodlers ask Google to create a doodle. This year they are also supporting other events and activities. Please go to their Facebook page HERE.

One week about ME on social media This is where people with ME are asked to share one picture a day about their ME during ME awareness week. Each day has a specific photo topic: smile for ME, your favourite low level activity, something which makes you feel better, get creative with spoons, something you're preparing for, a hand written message to fellow spoonies, you on a good day. There are also a topic to write about each day alongside your photo for example "I wish people without ME would..." The photos are to be shared on social media using the hashtag #1weekaboutME.


ME/CFS EVENTS

#Millionsmissing Virtual Protest – May 25

The #Millionsmissing protest is being organized by ME Action to draw attention to the plight of millions of people with ME/CFS. There are several things you can do to participate in #Milllionsmissing that do not require leaving your home.

1. You can send your shoes to Washington DC.

ME Action is asking patients who are unable to make it to the physical protest locations to please donate one pair of shoes. They will display them at the Washington, DC protest. You can send a pair of old shoes or if it’s difficult to get to the post office, order shoes on Amazon or Ebay and have them shipped directly. During the protest, images of these shoes will be posted to #MEAction’s social media account using the #MillionsMissing hashtag, so patients can see that they are being represented during the demonstration. Shoes cannot be returned. After the protest, they will be donated to a local charity or kept for a future installation.

Fill out this form and and then mail your shoes to: Paige Maxon, P.O. Box 26051, Winston Salem, NC 27114. All shoes must be postmarked by May 10th, 2016!

Send your shoes to London

You can also send shoes to the London protest. Fill out this UK form and mail to: LA Cooper, 25 Grassmead, Thatcham, Berkshire, RG19 4FP (UK)

Better yet – send to BOTH locations  

2. You can also put a pair of shoes at the end of your driveway or your doorstep.

On May 25th, take a pair of shoes (or several) and put them on your doorstep, lawn, or driveway. Take a photo and post it on social media #MillionsMissing. Anyone can participate. You might pair the shoes with a sign that expresses what the empty shoes mean to you. Some examples: “I cannot walk to the end of my driveway” or “My brother should be here.”

3. Use social media

On May 25th, post selfies on social media (Twitter, Facebook, Instagram, etc) – in your bed, home, wheelchair, at work, wherever you live – to help us show online the millions who are missing from the protest. Use the hashtag: #MillionsMissing so that we can aggregate all the photos. You can use #MEAction #mecfs #pwme to help identify your post.

You can hold your own #Missingmillions protest sign with a slogan in your photo. Here are a few examples to get started:
  • Missing my life for 22 years because of ME
  • Missing sufficient research
  • Missing adequate medical care
  • Missing a doctor who believes me
  • Missing college / Missing my family / Missing running in the park
4. Promote #Missingmillions

Promote the hashtag and shoe installation on your social media accounts. Email patients, friends, families, allies who are in the vicinity of the satellite protests http://millionsmissing.meaction.net/locations/

5. If you are in the US, send an informational packet to your representatives

Send this Forgotten Plague Congressional Pack to your congressmen/women and state representatives before the protest.

Find your congressional representative here: http://www.house.gov/representatives/find/

Find your Senator here: http://www.senate.gov/senators/contact/

Detroit, Michigan

New organization FIND (Foundation for Immunological and Neurological Diseases) will be hosting an
ME/CFS Awareness Walk 2016 - May 14, in Troy, Michigan (Detroit area), contact Frank Plizga -  sicnar@comcast.net

https://www.facebook.com/events/227053180988355/

The walk is from noon to 1 pm. So there are 5 confirmed walkers and 5 conditional. There will be balloons, signs and passouts.

Fundraising

Undies on the Outside Challenge

Help raise funds for OMF's End ME/CFS Project! WHY UNDIES ON THE OUTSIDE? Because superheroes wear their undies on the outside, and you have to be a superhero to live with this disease! Wearing underwear on the outside symbolizes bringing an invisible illness, which is usually hidden away, out into the open.

AUSTRALIA

The Do Something for ME project is designed to raise awareness in the general community about ME/CFS and to raise funds to support Emerge Australia to continue its work advocating for, educating about and providing information on the condition.

IRELAND

Walk for ME is a 5 km Charity Walk to raise Awareness and Funding for biomedical research into M.E. (Myalgic Encephalomyelitis) at the beautiful Belevedere House & Gardens. All proceeds going directly to the charity "Invest In ME" for biomedical research into M.E. “We're not strict on people finishing the full 5 km, if they're not able. A person can undertake any amount of distance.” For more information go HERE.

The Irish ME/CFS Association is pleased to announce that it has arranged for four free screenings of the documentary on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), Forgotten Plague, in various venues around Ireland during May, ME/CFS Awareness Month: 

- Limerick: South Court Hotel. Thurs, May 5. 11:30 AM. 

- Galway: Maldron Hotel, Headford Road. Thurs, May 12. 7.30pm 

- Dundalk: An Táin Theatre, Crowe Street. Tues, May 17. 2 PM. 

- Dublin: Crowne Plaza Dublin Blanchardstown. Sunday, May 29. 3 PM. 

These are the first public screenings of the documentary in Ireland. 

All are welcome. Further details are available on the Association’s website www.irishmecfs.org

UK

Please come support our #MillionsMissing UK Protest in London!


When: Wed. May 25th, 2016 12 PM – 2PM

Where: Department of Health Richmond House

79 Whitehall, London SW1A 2NS, United Kingdom

Be a part of the #MillionsMissing international day of protest, by attending #MillionsMissing UK, either physically or virtually. Come stand for the millions of severely ill patients living with this ME/CFS who are missing out on every day life. Whether you’re a patient, healthy ally or someone just learning of this disease, everyone is welcome to join in the fight for more funding for research and education.

To be at the protest in London, we suggest you bring a blanket, pillow, mobility scooter, or wheelchair to be as comfortable as possible. Consider wearing duct tape, with #MillionsMissing written across to represent this silent epidemic.

To particiapte virtually, please send shoes to the #MillionsMissing DC Protest or the #MillionsMissing UK Protest. To send shoes to the UK Protest, please mail to: 25 Grassmead, Thatcham, Berkshire, RG19 4FP (UK) 

Email L.A. Cooper with any questions at info@changeformechangeforus.co.uk

____________________

Blue Sunday

When: May 15

Where: UK

Blue Sunday is an event which has been going on for several years. Anna, the organiser invites you to have a coffee morning with your friends and family in aid of the ME Association. Guests are asked to bring the amount of money they would normally expect to pay for tea and cake as a donation. You can also take part in the national movement online, by joining in virtually! Here is a link to a blog post where Anna talks about the event in more detail, and here is a link to the online event, for those who are unable to attend an event or host their own. Here is a fundraising page, where you can join the team, or donate to a member of the team! You can read about the history of the event here.

____________________

Go blue for ME

This is organized by the ME Association, as blue is the color for ME awareness the public are encouraged to dress up in blue, or do something related to the color blue for ME awareness day which is the 12th of may, or for ME awareness week which is the 9th-15th of May. Share your blue antics on social media using the hashtags #GoBLUEME, #MEawareness or #MEawarenessweek! See the image below for more details.




Tuesday, May 10, 2016

#MillionsMissing ME/CFS Protest: Demands

Reprinted with permission from ME Action.

On May 25, 2016, at the #MillionsMissing demonstrations, Myalgic Encephalomyelitis (ME) and Chronic Fatigue Syndrome (CFS) patients and families, advocacy organizations and individual activists call for the US Department of Health and Human Services to implement the following list of demands.

Our goal is to give the 1 to 2.5 million[i] disabled American ME/CFS patients their lives back, and to prevent even more children, teens, young adults and adults from joining the ranks of the millions who are already missing — missing from their careers, schools, social lives and families due to the debilitating symptoms of the disease. 

Millions of dollars are also missing from ME/CFS research, and millions of medical providers are missing out on proper clinical training to diagnose and help patients manage this devastating illness.

For ME/CFS patients and their families, we demand:
  1. Increased Funding and Program Investments
Funding and program investments commensurate with the disease burden
  1.  Clinical Trials
Clinical trials to secure medical treatments for ME/CFS
  1.  Accurate Medical Education
Replacement of misinformation with accurate medical education and clinical guidelines
  1.  A Serious Commitment
HHS leadership, oversight and a serious commitment to urgently address ME/CFS

Rationale and Details for the #MillionsMissing ME/CFS Protest Demands

For ME/CFS patients and their families, we demand:

1. Funding and Program Investments Commensurate with the Disease Burden

The NIH must dedicate funding and program investments for ME/CFS commensurate with the disease burden, and they must do this without continued delay, as patients have already been waiting three decades.

Rationale

Thirty years of neglect by the NIH, combined with a stigma toward this disease, has resulted in insufficient and erroneous research as well as uninvolved academic researchers and pharmaceutical companies. To address these problems, and save lives, the NIH must immediately implement an aggressive set of investments to substantially ramp up its funding and program commitments over the next 3-5 years.

Details

To finally have NIH funding and investments commensurate with disease burden, our demand is to increase the paltry $7M per year currently allotted to ME/CFS to the more equitable amount of $250M. This new program of investments must be developed and executed in collaboration with ME research experts, clinicians and patients, and must include:
  • Funding five regional ME/CFS Centers of Excellence, each with a research/clinical trial component and also a clinical care component to address the current crisis.
  • Funding multiple requests for applications (RFAs) for ME/CFS over the next three years, for a total of $10M the first year, $20M the second year and $25M the third year.
  • A significant increase in funding for investigator-initiated extramural research (including hypothesis-generating research), as well as a commitment of intramural staff focused on ME research.
  • Funding a research network that will collaborate in the development and execution of an ME/CFS research strategy.
  • Funding an outreach plan to engage major academic centers and pharmaceutical and biotech companies in ME/CFS research and drug development.

2. Clinical Trials to Secure Medical Treatments for ME/CFS

HHS must fund and incentivize ME/CFS clinical trials to secure medical treatments for ME/CFS. This must be done with great haste, as patients are missing out on their lives and losing their lives to this disease.

Rationale

After thirty years, there is still not one Food and Drug Administration (FDA)-approved medication for the disease. An estimated one-quarter of ME/CFS patients are severely ill, meaning at least two hundred and fifty thousand patients are unable to leave their homes or bed, many for decades. With no FDA-approved treatments available to them, they have little hope of ever improving. To address this situation, HHS must fund and incentivize clinical trials in the following manner:

Details
  • We demand the NIH immediately partner with the FDA to address the key obstacles to moving clinical trials forward. NIH must also actively incentivize pharmaceutical and biotech industries so that at least five accelerated clinical trials of medications are conducted over the next five years. The goal must be getting at least two FDA-approved medications on the market for ME/CFS patients in the next five years. Proposed medications include Ampligen, Rituxan and antiviral medications, all drugs that have been in trials already and have been successfully used to treat ME/CFS patients.
  • The clinical trials must include severely ill, homebound patients, and must be overseen by an advisory team of ME/CFS specialists and researchers who best know the needs of this patient population.

3. Accurate Medical Education and Clinical Guidelines

The Centers for Disease Control and Prevention (CDC) must immediately discard its erroneous and outdated information related to ME/CFS and replace it with accurate medical education and clinical guidelines. The guidelines must be based on the most recent scientific information and the practices of ME/CFS experts, and be preapproved by a panel of recognized disease experts.

Rationale

It is morally reprehensible and medically unethical for the CDC to continue to disseminate erroneous and outdated information that can hurt patients. In spite of the findings of the 2015 Institute of Medicine (IOM) report, the CDC still includes references to psychological theories and treatments, such as GET (graded exercise therapy) and CBT (cognitive behavior therapy), even though the IOM report discredits the idea that this disease is psychological. This perpetuates medical confusion and puts ME/CFS patients at significant risk of harm. To address this situation, the CDC must immediately issue new ME/CFS medical education and clinical guidelines in the following manner:

Details
  • The CDC must immediately revise their ME/CFS medical education and clinical guidelines to replace erroneous and outdated information with updated, correct information based on the 2014 IACFS/ME Primer, and the IOM report, supplemented with the August 2015 recommendations from the CFS Advisory Committee. The IOM report stated that ME/CFS is not a psychological disease, yet much of the influential research on ME/CFS has focused on psychological factors. A 2015 NIH Pathways to Prevention (P2P) Report called for the retirement of the Oxford case definition because it is overly broad and includes people with other conditions including mental illness. Yet findings using the Oxford case definition are still being referenced in CDC material, even in new medical education information from the CDC and other medical education providers. This encourages an unethical focus on psychological factors and treatments, such as GET and CBT.
  • All medical education content must be approved by recognized ME/CFS expert clinicians, researchers and patients before publication.
  • The CDC must actively reach out to the larger medical community and to medical education providers to disseminate this updated content while simultaneously removing the erroneous information and material.

4. HHS Leadership, Oversight and a Serious Commitment to Urgently Address ME/CFS

HHS must demonstrate a serious commitment to ME/CFS commensurate with the severity and prevalence of the disease. This commitment must specifically remove all internal HHS impediments  to achieving rapid progress and must be implemented with the full and open collaboration of, and accountability to ME/CFS experts and patients.

Rationale

HHS’s lack of leadership and commitment to ME/CFS for the past thirty years has resulted in the neglect of a serious neurological disease and the abandonment of 1 to 2.5 million disabled Americans. HHS’s neglect has stalled research and drug development; disincentivized academic centers and pharmaceutical companies; and led to disbelieving medical providers, which has, in turn, resulted in a stigmatization of patients and abysmal, often harmful, clinical care. HHS’s short-sighted policies and unilateral actions have destroyed the scientific and medical infrastructure for ME/CFS that could have advanced research and proper care for patients. HHS must now act with a commitment, focus and sense of urgency regarding all aspects of its response to this disease in order to remedy the situation, as patients are losing their lives to this disease, many having spent years, even decades, too weak to function. In doing so, HHS’s decision-making process can no longer take place behind closed doors; HHS plans for ME/CFS must be developed and executed in conjunction with those who intimately know the disease: ME/CFS experts and patients.

Details
  • HHS Leadership, Oversight and Commitment
To ensure rapid progress, HHS must immediately accept the CFSAC Aug. 2015 recommendation of appointing a “senior-level cross-agency leader (“czar”) with the authority, position and fiscal responsibility required to coordinate, develop, implement, and monitor a broad strategic cross-agency response to this disease through open and collaborative engagement of both internal and external stakeholders.” The plan must be fast-tracked and must include long-term goals and milestones, as well as criteria for measuring progress. The currently established Trans-NIH ME/CFS Working Group does not address these needs, as it has no coordination of a cross-agency strategic response. That response must address not only research, but also drug development, epidemiology, medical education, access and quality of medical care and public awareness.
  • NIH Leadership, Oversight and Commitment
Given the multi-systemic nature of ME/CFS, it is crucial that each relevant Institute within the NIH must immediately put forth its own publicly-stated strategic and financial commitments and goals. To ensure coordination across the Institutes and to make rapid progress on an NIH research strategy, the Trans-NIH ME/CFS Working Group must continue. Finally, to ensure we make fast progress in the context of the NIH’s organizational structure, ME/CFS must be assigned to an NIH Institute right away. Given ME’s clear neurological dysfunction, the disease must be placed in the National Institute of Neurological Disorders and Stroke (NINDS) as recommended by CFSAC. 
  • CDC Leadership, Oversight and Commitment
To demonstrate their serious commitment to urgently address ME/CFS, the CDC must restore the ME/CFS budget which was eliminated in their 2017 budget justification submitted to Congress.  Additionally, the CDC must provide funds to conduct epidemiological studies to reassess prevalence, prognosis and risk factors. In doing so, the CDC must use the Canadian Consensus Criteria, as does the NIH in its current intramural study. Further, the CDC must implement a mechanism to ensure that a panel of recognized disease experts are involved in final decision making on all aspects of the CDC’s efforts related to ME/CFS.

Closing Note: These demands could change if there is any new information coming from the NIH, the CDC or HHS before the date of the #MillionsMissing demonstration on May 25, 2016.

Contact
To learn more, please contact
info@MEAction.net

###

Institute of Medicine of the National Academies. “Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness.” Institute of Medicine of the National Academies. Final report May 2015. http://www.iom.edu/Reports/2015/ME-CFS.aspx

Institute of Medicine of the National Academies. “Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness.” Institute of Medicine of the National Academies. Final report May 2015.  http://www.iom.edu/Reports/2015/ME-CFS.aspx

2015 Pathways to Prevention Report http://prevention.nih.gov/docs/programs/mecfs/ODP-P2P-MECFS-FinalReport.pdf
NIH Funding for Research by Disease.  https://report.nih.gov/categorical_spending.aspx

Mitchell WM, “Efficacy of rintatolimod in the treatment of chronic fatigue syndrome/ myalgic encephalomyelitis (cuffs/me).” Expert Review of Clinical Pharmacology. April 2016.http://www.ncbi.nlm.nih.gov/pubmed/27045557

Fluge O, Bruland O, Risa K, Storstein A, Kristoffersen EK, Sapkota D, Næss H, Dahl O, Nyland H, Mella O. “Benefit from B-Lymphocyte Depletion Using the Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome. A Double-Blind and Placebo-Controlled Study.” Plos One Oct 2011; 6(10): e26358.http://dx.doi.org/10.1371/journal.pone.0026358

Montoya M, Kogelnik A, Bhangoo M, Lunn M, Flamand L, Merrihew, Watt T, Kubo J, Paik J, Desa M. “Randomized Clinical Trial to Evaluate the Efficacy and Safety of Valganciclovir in a Subset of Patients With Chronic Fatigue Syndrome.” Journal of Medical Virology August 19, 2013. 85:2101–2109http://dx.doi.org/10.1002/jmv.23713

International Association for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis. “Chronic Fatigue Syndrome Myalgic Encephalomyelitis: A Primer for Clinical Practitioners 2014 Edition.”  2012, revised 2014.http://www.iacfsme.org/LinkClick.aspx?fileticket=iD3JkZAZhts%3d&tabid=509

Institute of Medicine of the National Academies. “Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness.” Institute of Medicine of the National Academies. Final report May 2015 . http://www.iom.edu/Reports/2015/ME-CFS.aspx

2015 Pathways to Prevention Report – Page 16 http://prevention.nih.gov/docs/programs/mecfs/ODP-P2P-MECFS-FinalReport.pdf 

Institute of Medicine of the National Academies. “Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness.” Institute of Medicine of the National Academies. Final report May 2015 http://www.iom.edu/Reports/2015/ME-CFS.aspx Page 1-3, 15-16, 27-31.

U.S. National Institutes of Health. Office of Disease Prevention. “Pathways to Prevention Workshop: Advancing the Research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. December 9-10, 2014. Executive Summary.” National Institutes of Health. Office of Disease Prevention. Final Report June 16, 2015 http://prevention.nih.gov/docs/programs/mecfs/ODP-P2P-MECFS-FinalReport.pdf

U.S. Department of Health and Human Services CFS Advisory Committee. Advisory Committee Meeting Recommendations. August 18-19, 2015. Last accessed September 12, 2015 http://www.hhs.gov/advcomcfs/recommendations/2015-08-18-19-recommendations.pdf

U.S. Department of Health and Human Services CFS Advisory Committee. Advisory Committee Meeting Recommendations. August 18-19, 2015. Last accessed September 12, 2015 http://www.hhs.gov/advcomcfs/recommendations/2015-08-18-19-recommendations.pdf

Centers for Disease Control and Prevention. Justifications of Estimates for Appropriations Committees. Fiscal Year 2017. http://www.cdc.gov/budget/documents/fy2017/fy-2017-cdc-congressional-justification.pdf Page 15.
Related Posts Plugin for WordPress, Blogger...