ME/CFS, Fibromyalgia, IBS, MCS, and Chronic Pain Redefined as Mental Disorders

In 2010, Drs. Fink and Schröder, two Danish psychiatrists, redefined several physiological illnesses as a single mental disorder: "bodily distress syndrome." Among the illnesses which Drs. Fink and Schröder reclassified are: Neurasthenia, chronic pain, Chronic Fatigue Syndrome, Myalgic Encephalomyelitis, IBS, Syndrome X, “heart-ache," Fibromyalgia, Whiplash Associated Disorder, pain in the pelvis when pregnant, electricity-hypersensitivity, infrasound-hypersensitivity and Multiple Chemical Sensitivity (MCS). 

The unstated rationale for the reclassification is that because these conditions don't fit into a medical "cookbook," a single psychiatric diagnosis would relieve physicians of the onerous task of spending the time required (i.e. more than 10 minutes) to diagnose and treat these patients. In short, patients with "unexplained" illnesses could now be shunted off to a therapist -  therapy being less costly than extended visits, extensive testing, and expensive treatment.

The diagnosis of "bodily distress syndrome" has as much scientific validity as "possession by evil spirits." But that has not prevented Danish agencies from adopting "bodily distress syndrome" as a legitimate diagnosis. This "diagnosis" provided the grounds for removing Karina Hansen from her home in February 2013 to a psychiatric hospital, for revoking her right to legal representation, for enforcing "evidence-based care" (exercise and cognitive behavioral therapy), and for prohibiting visits from her parents. 

(Below is the abstract of the Fink and Schröder study.)

One single diagnosis, bodily distress syndrome, succeeded to capture 10 diagnostic categories of functional somatic syndromes and somatoform disorders

By P. Fink and A. Schröder

ABSTRACT

BACKGROUND: In order to clarify the classification of physical complaints not attributable to verifiable, conventionally defined diseases, a new diagnosis of bodily distress syndrome was introduced. The aim of this study was to test if patients diagnosed with one of six different functional somatic syndromes or a DSM-IV somatoform disorder characterized by physical symptoms were captured by the new diagnosis.

METHOD: A stratified sample of 978 consecutive patients from neurological (n=120) and medical (n=157) departments and from primary care (n=701) was examined applying post-hoc diagnoses based on the Schedules for Clinical Assessment in Neuropsychiatry diagnostic instrument. Diagnoses were assigned only to clinically relevant cases, i.e., patients with impairing illness.

RESULTS: Bodily distress syndrome included all patients with fibromyalgia (n=58); chronic fatigue syndrome (n=54) and hyperventilation syndrome (n=49); 98% of those with irritable bowel syndrome (n=43); and at least 90% of patients with noncardiac chest pain (n=129), pain syndrome (n=130), or any somatoform disorder (n=178). The overall agreement of bodily distress syndrome with any of these diagnostic categories was 95% (95% CI 93.1-96.0; kappa 0.86, P<.0001). Symptom profiles of bodily distress syndrome organ subtypes were similar to those of the corresponding functional somatic syndromes with diagnostic agreement ranging from 90% to 95%.

CONCLUSION: Bodily distress syndrome seem to cover most of the relevant "somatoform" or "functional" syndromes presenting with physical symptoms, not explained by well-recognized medical illness, thereby offering a common ground for the understanding of functional somatic symptoms. This may help unifying research efforts across medical disciplines and facilitate delivery of evidence-based care.

Source: J Psychosom Res. 2010 May;68(5):415-26. doi: 10.1016/j.jpsychores.2010.02.004. P. Fink and A. Schröder. The Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital, 8000 Aarhus, Denmark. per.fink@aarhus.rm.dk

A Constitutional Right to Health Care

Press Release: UCLA, July 18, 2013

By Mark Wheeler

Uruguay has it. So does Latvia, and Senegal. In fact, more than half of the world's countries have some degree of a guaranteed, specific right to public health and medical care for their citizens written into their national constitutions.

The United States is one of 86 countries whose constitutions do not guarantee their citizens any kind of health protection. That's the finding of a new study from the UCLA Fielding School of Public Health that examined the level and scope of constitutional protection of specific rights to public health and medical care, as well as the broad right to health.

The study examined the constitutions of all United Nations member states and found the results to be mixed, despite the fact that all U.N. members have universally recognized the right to health, which is written into the original foundational document establishing the international body in 1948.The researchers reviewed the constitutions of all the member states as amended to two points in time: August 2007 and June 2011.

The report appears in the July issue of the journal Global Public Health.

The study also calls for regular and long-term monitoring of all countries' protection of health rights, whether or not such rights are written into specific country's constitutions.

That's because a constitutional definition of what health protection actually is varies widely between nations. Further, how such protections have been implemented varies widely, said the study's first author, Dr. Jody Heymann, dean of the Fielding School of Public Health.

"With respect to specific rights to health, the status of the world's constitutions can be described as either half empty or half full," Heymann said.

The study found that 73 U.N. member countries (38 percent) guaranteed the right to medical care services, while 27 (14 percent) aspired to protect this right in 2011. When it came to guaranteeing public health, the global performance was even poorer: Only 27 countries (14 percent) guaranteed this right, and 21 (11 percent) aspired to it.

But doing the math doesn't provide a comprehensive picture, said Heymann.

"There also exists gaps between individual countries that may have strong constitutional protections but poor records of implementing health rights on the ground," she said. "On the other hand, there are countries that lack constitutional provisions that have excellent health care systems in place."

The latter is particularly true in the case of older constitutions that have not been significantly amended since constitutional rights to health became common, she noted.

The good news, Heymann said, is the clear trend toward greater constitutional protection of health rights overtime. While only 33 percent of the constitutions adopted prior to 1970 addressed at least one health right, 60 percent of those introduced between 1970 and 1979 included the right to health, public health and/or medical care. Three-quarters of the constitutions introduced in the 1980s, and 94 percent of those adopted in the 1990s, protected at least one of these rights. Only one of the 33 constitutions adopted between 2000 and 2011 did not protect at least one health right.

"The global recognition of a right to health is a powerful step in guaranteeing health as a fundamental human right for all people," said Heymann. "But it is important to ensure this moral right moves from the philosophical to the practical. That will require a kind of transparency and accountability where the public can readily access information on which countries are implementing these guarantees.

"The U.S. Supreme Court's decision in June 2012 to uphold the Affordable Care Act was based on viewing the legislation as legal," said Heymann. "While the acknowledgement that Congress can provide for health is a step in the right direction, it is a long way from a guaranteed constitutional right to public health and medical care. The U.S., unfortunately, lags far behind many of the world's nations."

Other authors of the study included Amy Raub of UCLA, and Adele Cassolab and Lipi Mishrab of McGill University in Canada. Funding was provided by the Canada Foundation for Innovation.

The UCLA Fielding School of Public Health is dedicated to enhancing the public's health by conducting innovative research; training future leaders and health professionals; translating research into policy and practice; and serving local, national and international communities.

Dr. De Meirleir Talks About ME Treatments

Web Seminar by Dr. Kenny De Meirleir, March 1, 2013

The video can be found at: http://www.youtube.com/watch?v=IO_VR73v2Ns

Q: Oxygen Therapy: What Are the Pros and Cons?

Administration of oxygen therapy has advantages and disadvantages. Oxygen increases the release of free radicals, which can be harmful. On the other hand oxygen can be very useful for people with severe pain and strong acidification. The oxygen used at home isn’t administered in oxygen cylinders any more. It comes from a device that transforms the air into almost 100% pure oxygen.

Q: Is the oxygen one gets in the hospital the same as your oxygen therapy?

The oxygen one gets from an oxygenator is the equivalent to the oxygen one gets in a hospital.

Q: What do you expect from rituximab?

I don’t consider this to be a long-term solution, because practically all patients relapse. A new injection is necessary after six to twelve months, which is extremely expensive. The young and healthy B-cells formed after rituximab treatment will function properly in the beginning, but after a while they will again become involved in the disease process. Therefore rituximab isn’t a definitive solution.

Q: Is Ampligen effective? For whom? How does it work?

My experience with Ampligen dates from 1992-2001.  We gave Ampligen to approximately 150 people during that time. Ampligen partially works like interferon and combats the viral aspect of the disease. So, those ME patients in whom the viral aspect of the disease is dominant will profit most from it.

Q: Are you familiar with fecal transplants? Is this a useful approach?

We have heard of some patients who have chosen to have a stool transplant. During the transplant, stool from the intestines is removed and replaced by stool from a healthy individual. I believe this can also provide temporary improvement as fewer toxins are released in the body. But, again, it is not a definitive solution, because the problem isn’t so much the intestines as the immunity of the intestines. The abnormal flora will grow again. In addition, a stool transplant isn’t a pleasant experience, and must be repeated regularly. The only indication for this in ME patients is for those who have an overgrowth of C. difficile, which is extremely toxic, but the same would hold true even for people who don’t have ME.

Q: Can you briefly explain heart-rate monitoring and pacing? What do you expect from these?

Several researchers have found that ME patients have irregular heart rhythms. This is due to changes in the sympathetic nervous system, causing inadequate control over heart rhythm. I do think that monitoring can help, but again, this isn’t a treatment of the cause. Pacing helps patients to use less energy. That is, energy is reserved for those things which are essential, in order to make it through the day. Pacing is an alternative for people who are chronically ill and who have few treatment options. They must learn to deal with the amount of energy they have left. Pacing should be addressed when the patient has tried all normal treatments.

Q: Doesn’t long-term administration of antibiotics kill the colonic flora?

When one administers broad-spectrum antibiotics for a very long time, then one destroys the colonic flora. But when one is very careful and uses narrow-spectrum antibiotics to treat a specific infection this will not happen. There are numerous examples, as in tuberculosis, in which one administers antibiotics for eighteen months. But treatment involves a narrow-spectrum antibiotic, and therefore the colonic flora aren’t seriously disturbed. In the case of very acute infection one chooses broad-spectrum antibiotics. But when one is going to use long-term antibiotics to combat a very specific intracellular infection one chooses a narrow-spectrum antibiotic that has little effect on the colonic flora.

RELEASE KARINA HANSEN

Karina Hansen

This article originally appeared on ProHealth.

By Holly Latham 

Why should the M.E./CFS community rally around Karina Hansen and her family?

Karina Hansen is a 24-year-old Danish woman who has had M.E. (myalgic encephalomyeltitis) since she was 16. On February 12, 2013, five policemen, two doctors, two social workers, and a locksmith came to her home and forcibly removed Karina Hansen from her bed and transported her to Hammel Neurocenter. 

Karina was able to make a call the next day to her mother saying, "“How can I get out of here? I can’t take this." Since that time her parents have been prohibited from seeing her even though preventing relatives from visiting their family members in the hospital is a violation of basic human rights.

Shortly afterwards, Karina’s parents received a letter from a psychiatrist, Nils Balle Christensen, which said that he would be in charge of Karina’s treatment at Hammel Neurocenter. (In May 2012 a previous attempt to section Karina was unsuccessful, as she has always been declared psychologically healthy.) There is no evidence or even any charge of physical, mental, or emotional abuse by Karina's parents and also no evidence that Karina is mentally ill. She was taken from her home because she and her parents chose against the type of treatment the Research Clinic for Functional Disorders and Psychosomatics offers. Her parents had chosen to pay for a private physician and dietician to treat Karina, because they strongly felt that the treatment offered by Dr. Nils Balle Christensen would be detrimental. 

What is this treatment? Why is this treatment bad for her?  

Nils Balle Christensen, the psychiatrist in charge of Karina's care, works for The Research Clinic for Functional Disorders and Psychosomatics. This clinic classifies illnesses such as CFS, fibromyalgia, and irritable bowel syndrome as “bodily distress syndrome.” This is a new diagnosis created by these doctors and is classed as a type of functional disorder. The treatment for a functional disorder is listed on their website as cognitive behavioral therapy, graded exercise therapy, and in some cases antidepressants.* 

Graded exercise therapy can be detrimental to patients with M.E. (Twisk, Maes 2009).* Studies have proven that people with M.E. respond poorly to exercise, especially patients who are severely ill, like Karina (VanNess et al 2008 and Ciccolella et al 2007). 

Cognitive behavioral therapy (CBT) was not designed to treat serious illnesses, such as M.E.  It is intended to change how people think, specifically “illness worries.” According to the Research Clinic, “Illness worries are thoughts about your illness or symptoms that make you worry that you may be seriously ill."* Karina Hansen and her parents have already said no to CBT. Karina is seriously ill, not “worried.”

Why should you care?

Karina's case sets a very bad precedent for other M.E. sufferers in Denmark and around the world. Is this the future of M.E. treatment? If this diagnosis and treatment are included in diagnostic and/or treatment manuals used worldwide, forced treatments, such as the ones Karina is being subjected to, could reach far beyond Denmark. Will you be able to seek any kind of treatment anywhere if you fear this will be the result? 

We need to remember that Karina Hansen did not choose this treatment. Karina Hansen had hired a lawyer and given her parents power of attorney. She had a physician. Yet, their efforts to give her the right to choose her own treatment were ignored. This could happen to any of us.

How do we make this case widely known?

Share! Share! Share! The more people that show they care, the more likely it is that officials will take notice and act.

Here are just some of the places you can find information and updates about Karina:

• YouTube video.Please note this video has a posted amendment to the information about Sophia Mirza.
• ME Association, Denmark Facebook page. 
• Justice for Karina Hansen Facebook page.
• YouTube video update.

What can you do to help?

• Send a postcard! Karina is getting these postcards! Let's show her and the hospital staff that Karina has worldwide support! Information for sending postcards is here. The ipetiton is here.
• Sign these petitions! Sending a postcard can be more than some of us can manage. Here are some petitions you can sign in addition to the ipetition: Change, Causes
• Write a polite letter or email to Danish officials. We want the M.E./CFS patient community to be represented in a positive manner. A sample template written in consultation with Rebecca Hansen, chairperson of the ME Association Denmark , can be found below. There is a place to fill in your own experience with M.E. on the template. Remember to sign your name at the end! You can find the addresses here.
• Write a letter to Amnesty International. The template for the letter is here.

Any and all opinions are my own. Information was gathered from these sources as well as the referenced materials listed below:

•  ME Association, Denmark 
•  A Visit to Karina – a Question of Human Rights by Rebecca Hansen

Referenced materials:

1. Functional Disorders
2. Twisk and Maes, A Review on CBT and GET
3. VanNess M, Snell C, Stevens S. Diminished cardiopulmonary capacity during post-exertional malaise. Journal of Chronic Fatigue Syndrome 2007; 14(2): 77-85 
4. Ciccolella M, Stevens S, Snell C, VanNess M. Legal and scientific considerations of the exercise stress test. Journal of Chronic Fatigue Syndrome 2007; 14(2): 61-75
5. Bodily Distress Syndrome

Template for writing officials in Denmark:

(Please add your personal experience with M.E. and any problems you have suffered resulting from any inappropriate treatment you have received.)

Dear Sir or Madam:

I am writing to you concerning the treatment being offered in Denmark to those suffering from myalgic encephalomyelitis (M.E.). In case you are unfamiliar with M.E., it is a debilitating physical illness that has been classified as a neurological illness by the World Health Organization since 1969. 

It has been brought to my attention that a young woman with myalgic encephalomyelitis named Karina Hansen has been forcibly removed from her home on February 12, 2013 for treatment she did not choose.

Karina is at Hammel Neurocenter and being treated by Nils Balle Christensen, a psychiatrist with The Research Clinic for Functional Disorders and Psychosomatics. Karina's parents have not been allowed to visit her despite the fact that preventing relatives from visiting their family members in the hospital in Denmark is not allowed. It is my understanding that human rights, such as being allowed to visit one's family, should be given the highest priority.

This situation has prompted many people around the world to ask:

• Does Denmark recognize the World Health Organization code for M.E.? Please note that benign myalgic encephalomyelitis is coded as G93.3 in the chapter entitled "Diseases of the Nervous System" under the subheading "Other disorders of brain." To further clarify, myalgic encephalomyelitis is listed under diseases of the nervous system and NOT mental and behavioural disorders. It is my understanding that any country that accepts the WHO Regulations for nomenclature is obligated to accept the ICD classification. If Denmark accepts the ICD classification of M.E. as a neurological illness, than why are doctors who specialize in mental and behavioural disorders in charge of an M.E. patient's treatment?
• Is forced psychiatric treatment the future of all M.E. patients and their families? Myalgic encephalomyelitis can result in death without proper medical treatment. One well-known case is that of Sophia Mirza in England. 
• Do M.E. patients in Denmark not have the right to choose which treatment they receive?
• Who monitors experimental treatments for M.E. such as Graded Exercise Therapy and Cognitive Behavioural Therapy to be certain that no basic human rights are being denied?
• Do patients with M.E. not have the basic human right to see their families?

Many people around the world are concerned with Karina Hansen's treatment and have signed petitions in support of Karina and her family. These actions show that Karina Hansen and her family have worldwide support.

I ask that you please do all within your power to restore Karina Hansen's human rights and see that she has proper medical treatment for myalgic encephalomyelitis.

I would appreciate your prompt attention to the matter. Thank you for your consideration.

Sincerely,
(your name)

Karina Hansen - "You are killing me."

This is the first in a series of videos documenting the plight of Karina Hansen, a young woman with severe ME/CFS who was forcibly removed from her home on February 12, 2013 and placed under the care of psychiatrists. She is currently being treated with GET (graded exercise therapy) and CBT (cognitive behavioral therapy). Karina has told the staff at the Hammel Neurocenter, "You are killing me."

Post Polio Syndrome and ME/CFS: Common Ground

Mia Farrow

Years ago, I read a book by Dr. Richard L. Bruno called "The Polio Paradox: Understanding and Treat 'Post-Polio Syndrome' and Chronic Fatigue" (published in June 2002 by Warner Books).

I was struck by the number of similarities between PPS and ME/CFS, which, combined with the fact that so many early outbreaks of ME/CFS occurred on the heels of polio epidemics, led me to believe the ME/CFS was caused by an enterovirus. Because the poliovirus, a member of the enterovirus family, caused extensive damage to the nervous systems of polio victims, the symptoms can be as varied as those of ME/CFS. Like ME/CFS, these symptoms can also persist for decades.

While the evidence of a causal link between the two illnesses would be hard to establish, there can be no question that they both are devastating, and that managing them is essential. As Dr. Bruno said in his book, "If you are standing and can sit, then sit. If you are sitting and can lie, then lie down." I have always taken that piece of advice seriously, much to my benefit.

Below is a letter written by the actress Mia Farrow, who was stricken by polio at age nine, and her son, Thaddeus, who was paralyzed by polio at age twelve. You will be struck by our common experience.

For more information, please visit the Post-Polio Institute.

By Mia Farrow

POST-POLIO SYNDROME: AN OPEN LETTER 

WHAT ARE POST-POLIO SEQUELAE?

Post-Polio Sequelae (PPS, Post-Polio Syndrome, The Late Effects of Poliomyelitis) are the unexpected and often disabling symptoms -- overwhelming fatigue, muscle weakness, muscle and joint pain, sleep disorders, heightened sensitivity to anesthesia, cold and pain, as well as difficulty swallowing and breathing -- that occur about 35 years after the poliovirus attack in 75% of paralytic and 40% of ''non-paralytic'' polio survivors. There are about 2 million North American polio survivors and 20 million polio survivors worldwide. The existence of PPS has been verified by articles in many medical journals, including The Journal of the American Medical Association, the American Journal of Physical Medicine and Rehabilitation and The New England Journal of Medicine.

WHAT CAUSES PPS?

PPS are caused by decades of ''overuse abuse.'' The poliovirus damaged 95% of brain stem and spinal cord motor neurons, killing at least 50%. Virtually every muscle in the body was affected by polio, as were brain activating neurons that keep the brain awake and focus attention. Although damaged, the remaining neurons compensated by sending out ''sprouts,'' like extra telephone lines, to activate muscles that were orphaned when their neurons were killed. These over sprouted, poliovirus-damaged neurons are now failing and dying from overuse, causing muscle weakness and fatigue. Overuse of weakened muscles causes muscle and joint pain, as well as difficulty with breathing and swallowing.

HOW ARE PPS DIAGNOSED?

There is no diagnostic test for PPS, including the electromyogram (EMG). PPS are diagnosed by excluding all other possible causes for new symptoms, including abnormal breathing and muscle twitching that commonly disturb polio survivors' sleep, a slow thyroid and anemia. Other neurological or muscle diseases are almost never the cause of PPS symptoms.

ARE PPS LIFE-THREATENING?

No. But because of damaged brain activating neurons polio survivors are extremely sensitive to, and need lower doses of, gas and intravenous anesthetics and sedative medication. Polio survivors can have difficulty waking from anesthesia and can have breathing and swallowing problems, even when given a local dental anesthetic.

IS PPS A PROGRESSIVE DISEASE?

PPS is neither progressive nor a disease. PPS is caused by the body tiring of doing too much work with too few poliovirus - damaged, oversprouted neurons. However, polio survivors with untreated muscle weakness were found to lose about 7% of their remaining, overworked motor neurons each year.

IS THERE TREATMENT FOR PPS?

Yes. Polio survivors need to ''conserve to preserve,'' conserve energy and stop overusing and abusing their bodies to preserve their abilities. Polio survivors must walk less, use needed assistive devices -- braces, canes, crutches, wheelchairs -- plan rest periods throughout the day and stop activities before symptoms start. Also, since many polio survivors are hypoglycemic, fatigue and muscle weakness decrease when they eat protein at breakfast and small, more frequent, low-fat / higher-protein meals during the day.

ISN'T EXERCISE THE ONLY WAY TO STRENGTHEN WEAK MUSCLES?

No. Muscle strengthening exercise adds to overuse. Pumping iron and ''feeling the burn'' means that poliodamaged neurons are burning out. Polio survivors typically can't do strenuous exercise to condition their hearts. Stretching can be helpful. But whatever the therapy, it must not trigger or increase PPS symptoms.

IS TREATMENT FOR PPS EFFECTIVE?

Yes. The worst case is that PPS symptoms plateau when polio survivors stop overuse abuse. Most polio survivors have significant decreases in fatigue, weakness and pain once they start taking care of themselves and any sleep disorders are treated. However, because of emotionally painful past experiences related to having a disability, many polio survivors have great difficulty caring for themselves, slowing down and especially with "looking disabled" by asking for help and using assistive devices.

WHAT CAN DOCTORS, FAMILY, AND FRIENDS DO TO HELP?

Polio survivors have spent their lives trying to act and look ''normal.'' Using a brace they discarded in childhood and reducing overly-full daily schedules is frightening and difficult. So, friends and family need to be supportive of life-style changes, accept survivors' physical limitations and any new assistive devices. Most importantly, friends and family need to be willing to take on taxing physical tasks that polio survivors may be able to do but should not do. Doctors, friends and family need to know about the cause and treatment of PPS and listen when polio survivors need to talk about how they feel about PPS and lifestyle changes. But friends and family shouldn't take control of polio survivors' lives. Neither gentle reminders nor well-meant nagging will force polio survivors to eat breakfast, use a cane or rest between activities. Polio survivors need to be responsible for caring for their own bodies and ask for help when they need it.

Whether you had polio or not, please COPY and MAIL this letter to your doctors. With your help every doctor will learn about the cause and treatment of PPS and give polio survivors the care we so desperately need. Thank you!

Signed, Mia Farrow, polio survivor and Thaddeus Farrow, polio survivor

Send a message to Congress: We can't wait any longer!

The Bob Miller team is once again springing into action. This letter (see below) is a call for the FDA to hold a follow-up meeting to expand upon the FDA meetings of April 25-26.  (You can read a summary of Day One of the FDA meeting here. You can read summaries of the Day Two morning sessions here, and Day Two afternoon sessions here.)

Why is this necessary? 

The FDA meetings opened the door for people in government, and in industry, to start thinking about ME/CFS treatments. Although it's nice that they are beginning to think, the epidemic that marked the beginning of agency concern about ME/CFS happened nearly 30 years ago. We can't wait another 30 years. 

By Bob Miller

We, the “FDA Team*,” are asking you to send the message below to the FDA and to listed members of Congress.

The recent patient-focused drug development meeting held by the FDA was a start – but only a start. The FDA stated that their goal was to support treatments for the chronically ill, particularly where there is a drug deficit, yet the meeting fell short of meeting that goal.

The original goal of the FDA Stakeholders was to provide a clear regulatory pathway that would support faster drug development for ME/CFS. That obviously did not happen.

Now Bob Miller and others on our team are continuing communication at the top level, including with Dr. Janet Woodcock, Director of the Center for Drug Development and Research at the FDA. We have informed her that your messages will be sent to one of her staff members, David Banks PhD, of Special Health Issues.

We want them to hear from you, family and friends. This keeps critical channels of communication open.

NUMBERS COUNT!

AIDS patients demanded one thing: Treatment. And they got it! We must demand the same.

Please email the following to David Banks and myself, Bob Miller. (I am monitoring how many emails are sent along with other FDA team members.) Also, we ask you to CC others in the Department of Health and Human Services and congressional staff members so they can influence the FDA.

Just copy and paste, please add your name and address or email information at the end. (As always, this is just a suggested template for your convenience):

To: David.Banks@fda.hhs.gov, 511bobmiller42@gmail.com
Cc: howard.koh@hhs.gov, Sara_Mabry@casey.senate.gov, Karen_Wade@hagan.senate.gov, Eamonn_Hart@blumenthal.senate.gov, Carolyn_gluck@reid.senate.gov
monica.volante@mail.house.gov, robb.walton@mail.house.gov, rebekah.armstrong@mail.house.gov, eric.fox@mail.house.gov, christopher.Stewart@mail.house.gov, ryan.mcBride@mail.house.gov

Subject: ME/CFS Treatments

Dear Dr. Woodcock:

Over 1 million Americans and their families continue to suffer with ME/CFS. Patients have no treatment options as there are no FDA-approved treatments. One drug has been stuck in the pipeline for two decades (Ampligen), and there are no others likely to be reviewed for years to come. The recent patient-focused drug development meeting fell short of meeting the needs of ME/CFS patients. By the end of this year, FDA must convene a follow-up meeting to engage pharmaceutical and biotech companies to assist the FDA in establishing a regulatory pathway for drug approval.

The stakeholder meeting held on April 25th and 26th opened the FDA’s eyes to the severity of our condition and the enormous Unmet Medical Need. FDA has the power and the authority to waive traditional regulations when healthcare demands, particularly when the disease is serious/life-threatening, as ME/CFS clearly is. We need access to treatments NOW. Please act now for us! Don’t stop the progress; let’s keep it going. We cannot wait another decade for relief. People are suffering and dying.

Thank you,

“Place Your Name Here”:
“Place Address and/or Email Here”

- – - End of your email message – - -

*The FDA Team includes:

Cort Johnson, patient and principal of Health Rising

Robert Miller, ME/CFS patient /activist and (Courtney Miller, patient wife FDA Team support)

Lori Chapo Kroger, patient and president of PANDORA Org.

Pat LaRosa, patient / patient advocate

Billie Moore, parent of patient lost to ME/CFS & patient advocate

The Blue Ribbon: Ryan Prior's Documentary about ME/CFS

Ryan Prior's documentary, the Blue Ribbon, is seeking funding on Kickstarter, a service that enables new filmmakers to realize their visions. You have only a week to show your support for this ambitious project! Now is the time! (With a $25 donation,  you get a free download of the film.)

The following excerpt is from Kickstarter. (Click on the video to watch the trailer.)

THE BLUE RIBBON is a film exposing the hidden story of ME/CFS. It features interviews with top researchers, doctors, and activists.

"ME/CFS is the great under-reported medical story of the times." Llewellyn King, host of PBS's White House Chronicle and columnist for the New York Times-Hearst Syndicate.

The story of this film begins with a story I wrote for USA TODAY about my struggle with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) over the last 6 years. The response to the article marked me deeply. People from all over the world wrote in describing the pain of living with the illness. Many talked of decades unable to work or even to participate in normal life.

Patients feel a constant, unrelenting exhaustion that is unrelieved by sleep, rest, or exercise. Because there is no treatment, they are often disabled.

I started to feel a moral calling for an in-depth creative and journalistic investigation into the roots of this illness; it was a calling to give these unheard voices a forum to speak to a world that has neglected them for far too long. I firmly believe that the first step to improving these lives is for greater global awareness of ME/CFS. Only then can we receive more research research funding and remove the sad stigma that often prevents a frank international conversation beginning at all. This film is the best way of doing that.




I started to feel a moral calling for an in-depth creative and journalistic investigation into the roots of this illness; it was a calling to give these unheard voices a forum to speak to a world that has neglected them for far too long. I firmly believe that the first step to improving these lives is for greater global awareness of ME/CFS. Only then can we receive more research research funding and remove the sad stigma that often prevents a frank international conversation beginning at all. This film is the best way of doing that.

ME/CFS is a devastating illness that the CDC now estimates affects well over a million Americans and more than 20 million people worldwide. ME/CFS is a illness with no cure; it also has no single known cause. It is a complex, multi-system disorder that, although fairly widespread, remains extremely difficult to diagnose and treat. Many, many patients fall through the cracks in the medical system and the social safety net, lose family support, and essentially disappear from society altogether. According to a 2008 study, ME/CFS causes at least a $20 billion cost on the U.S. economy alone through lost wages, healthcare spending, and lost productivity. Yet, according to recent numbers, the National Institutes of Health allocates just $6 million annually to research. This is just a tiny fraction of the funding given to illnesses of similar severity.

In telling the story of ME/CFS with this film we are essentially telling the story of the future of medicine itself. And that is truly a message that all of society can gladly get behind. We plan to travel through 10 cities across North America interviewing activists, patients, researchers, and doctors. We'll produce a feature-length film documentary for release on Netflix, Hulu, iTunes, and Amazon Video on Demand. Yet even more than that, we plan to equip people in towns and cities across the world to stage screenings of the film in movie theaters, schools, hospitals, churches, and community organizations. It's a tragic fact of this illness that most patients are far too ill to protest in the streets in order to get society to hear our voices. However, we can tell this story through a documentary film, widely distributed through grassroots organizing. We can tell the story, together, and help build bridges between communities of faith, politics, science, and the arts. True change will happen person by person, one community at a time.

Nicole and I could never do this project on our own. This is a community project. It requires not only funding from individuals and organizations but also an army of people across the world who are on fire about this film and its message, who want to tell anyone and everyone about it. We'll make the documentary. We'll distribute it on Netflix, Hulu, and iTunes. But we'll need each and every one of you to help make its message stick.

We've been reaching out to prominent researchers, activists, and scholars in the ME/CFS community and we've been excited about the response so far. But more importantly, we're delighted about the surprisingly strong response from all the "ME/CFS agnostics" with whom we've been talking. People with backgrounds in law, politics, science, faith, and the arts are moved by the struggle of people with ME/CFS and see this project just as we do. It is nothing less than a struggle for social justice. Come join us!

UK ME/CFS Biobank project awarded £1 million grant

Press Release: LSHTM Communications Team, June 28, 2013

A pioneering biobank project aimed at the study of Myalgic Encephalomyelitis (ME) / chronic fatigue syndrome (CFS) has been awarded a grant totalling £1,029,411 ($1,588,225) over three years by the US National Institutes of Health (NIH).

A biobank is a large collection of biological samples including tissues such as blood, which provides a valuable database for scientific research. Patients with an illness, as well as healthy people (controls), volunteer their tissues for inclusion, and each sample can be linked with detailed clinical information about the donor.

The UK ME/CFS Biobank was launched in 2011. It is the only one in the UK and the first in Europe aimed at the study of the illness. The project is led by the London School of Hygiene & Tropical Medicine and is currently funded by the ME Association, Action for ME, ME Research UK and a private donor.

Samples for the ME/CFS Biobank are obtained via NHS primary care networks and other sources, and are then processed and securely stored at the University College London/Royal Free Hospital Biobank.

During phase one of the project, researchers successfully banked samples from over 100 clinically assessed ME/CFS patients and controls, along with key clinical information about the donors, which has been anonymised to maintain patient confidentiality.

The grant from the NIH will enable important research on the immunology and genetics of ME/CFS, which may lead to the discovery of much needed disease biomarkers. It will also help to expand the Biobank to store samples from over 500 participants, including almost 300 patients and over 200 controls (comprising healthy controls and people with multiple sclerosis), which will be made available to medical researchers internationally.

Dr Eliana Lacerda from the London School of Hygiene & Tropical Medicine, one of the lead researchers on the project, said: “At least one in every 500 adults in the UK is affected by ME/CFS at any one time, as well as a smaller but significant proportion of children. The NIH grant provides a huge boost to the Biobank, which will enable more research into the causes of ME/CFS and ultimately help those affected.”

Erinna Bowman, one of the project researchers, said: “A key component of our project is its longitudinal design, which includes participant follow-ups over an extended period of time. This longitudinal aspect makes the Biobank an even more valuable resource and presents new opportunities for scientific discovery in the years to come.”

The London School of Hygiene & Tropical Medicine is home to a dedicated research group working on research into ME/CFS.