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The First ME/CFS Fecal Transplant Study Suggests the Treatment Holds Promise

Finally a (chronic fatigue syndrome) ME/CFS fecal transplant study. It’s long past due (Maybe way, way long past due –  the Chinese pioneered fecal transplants 2000 years ago but used a cruder method in people dying of diarrhrea – drinking them.)

This first stab at a fecal transplant study isn’t a big statistically rigorous, randomized, placebo-controlled trial. Far from it; it’s more a series of case reports from a physician’s practice over time with a smattering of statistics. It does give us, though, our first data -in rather vivid detail – on the possible efficacy of fecal transplants in ME/CFS.

gut lumen diagram

The gut lumen – from “Does the microbiome an virome-contribute to ME/CFS.-Clin-Sci. March 2018

Ten studies now indicate that the bloom is off in the gut flora of people with ME/CFS. With a 2018 review taking ME/CFS researchers to task for the usual suspects: lack of standardization in patient selection, sample processing, genome sequencing and data analysis, it’s not clear what has gone wrong.

As papers just pour out implicating the gut flora in a wide range of diseases the question becomes more and more what to do about it.  While pre and probiotics can help, it’s possible that fecal transplants – the direct transfer of stool (or portions of the stool) from a healthy person into the gut of an ill person –  may provide a larger, more lasting impact.

The Study

Dr. Julian Kenyon runs The Dove Clinic for Integrated Medicine, in the U.K.  which uses both an oral (pre and probiotics, diet, etc.) and fecal transplant approach to gut improvement.  In this study  – A Retrospective Outcome Study of 42 Patients with Chronic Fatigue Syndrome, 30 of Whom had Irritable Bowel Syndrome. Half were treated with oral approaches, and half were treated with Faecal Microbiome Transplantation – he compared the results of the two.

Kenyon divided his patients into two groups of 21; one was treated with nutritional remedies, probiotics, prebiotics, and dietary and lifestyle advice. The second group, most of whom had failed the first treatment approach, were given 10 fecal implants over ten days.

As seventy percent of the group also had irritable bowel syndrome (IBS) this may have been a more gut impacted group. In an effort to deliver a maximum diversity of flora, each of the implants came from a different, “carefully screened” donor.

The Taymount Laboratory provided the implants. The laboratory runs a 10-day gut flora transplant (FMT) program which starts off with a colon cleanse and includes dietary advice.

While it’s not possible to test donors for all possible pathogens (some of which may be undetectable), the donors’ blood was screened for the following pathogens: Human Immunodeficiency Virus (HIV) 1/2, Hepatitis A. IgM, Hepatitis B (HBsAg), Hepatitis C antibody, Syphilis, IgG/IgM, Full Blood Count, Urea and Electrolytes, Ferritin, C-Reactive Protein, Tissue Transglutaminase, CMV, H-Pylori.

Their stool samples were screened for: Campylobacter (Jejuni, Coli and Upsalliensis), Clostridium Difficile (A/B), Salmonella, Yersinia Enterocolitica, Vibrio (Parahaemolyticus Vulnificus and Cholera), Diarrhoea-causing E-Coli/Shigella, Enteroaggregative E-Coli (EAC), Enteropathogenic E-Coli (EPEC), Enterotoxigenic E-Coli (ETEC), Shiga-like toxin-producing E-Coli (STEC), E-Coli 0157, Shigella/Enteroinvasive E-Coli (EIEC), Cryptosporidium, Cyclospora Cayetanesis, Entamoeba Hystolitica, Giardiolambia, Adenovirus, Astrovirus, Norovirus GI/GLL, Rotavirusa, Sapovirus.

The Taymount Laboratory website reports that there’s no documented evidence  infections being passed via fecal transplants. As of this month, though, that’s no longer true. The FDA recently reported on two multi-drug resistant infections passed via fecal transplants.

Different kinds of transplant techniques are used. Some clinics use a tube to insert the transplant through the esophagus and into the stomach or the duodenum. This clinic uses a rectal catheter to deliver the goodies into the large bowel or colon. Others use something called a colonoscope.  Some companies are creating pills that can be swallowed.


The study reported on past patient outcomes (retrospective case-control) using a vague metric indeed, “% improvement”, to assess results. While the statistics were crude, the data presented – in short statements describing how the patients improved or didn’t improve – provided vivid reading indeed.

The statistics (Mann-Whitney test of “% improvement:  U=111.5, p=.003) indicated dramatically increased improvements in the fecal transplant group compared to the “oral” (probiotic, nutritional supplements, etc.) group.

The Fecal Transplant Group

As noted above the fecal transplant group were tough cases: they hadn’t responded to Dr. Kenyon’s normal treatment regiment of supplements, pre and pro-biotics etc.

Dr. Kenyon’s data suggested that little grey area existed:  the fecal transplants either hit or missed: when they hit, they tended to work quite well; when they missed, they pretty much missed entirely.

In quite a few cases, the transplants were associated with some striking increases in energy. Kenyon reported that the energy levels of 7 of the fecal transplant group returned to normal, practically normal or almost normal. (In one case she simply said “chronic fatigue syndrome resolved”.)

The increases in energy did not come in the newly ill either. Six people who’d had ME/CFS “for many years” either totally recovered or were dramatically improved. One 66 year old person who apparently got ill following an amoebiasis infection in the Himalayas over 30 years ago returned to normal health.

The energy levels of six others were “significantly improved”, “much improved”, “improved dramatically” or “consistently improved”.

In a few cases, it was impossible to determine if improvements in energy had occurred. For instance, Dr. Kenyon reported that the gut problems of a person with severe vaginal thrush, recurrent abdominal bloating, IBS and ME/CFS largely disappeared but didn’t assess her energy levels.  The same occurred with another person with IBS: their IBS disappeared but we weren’t told if her energy levels improved as well.

Four people (@20%)  were either unable to tolerate the implants (n=2) or showed no improvement (n=2).

Table 1. Chronic Fatigue Syndrome Patients treated with FMT

Patient: %Improved
(F)Age 36 Severe Chronic Fatigue Syndrome with Irritable Bowel Syndrome for three years, following multiple antibiotics for Quinsy. Severe debilitating Irritable Bowel, with lack of energy. She had FMT in February 2018, following this the Irritable Bowel cleared up, energy significantly better. Has always had many food sensitivities, they are gradually beginning to resolve. A further course of FMT is under consideration. 70%
(F)Age 40 Polycystic Ovary Syndrome, also Irritable Bowel and a Chronic Fatigue. She had FMT in October 2017, following the FMT her energy is much improved and is practically normal, has remained so ever since. Also, her mood is more stable. 90%
(F)Age 59 Severe Vaginal Thrush for five years, recurrent abdominal bloating, Irritable Bowel Syndrome and Chronic Fatigue Syndrome. Clostridium Difficile in 2013. She had FMT in May 2017, two months after FMT the Irritable Bowel cleared up completely, her skin is significantly better than it was prior to treatment, Vaginal Thrush is still something of a problem, but not as bad as it was. She finds she is no longer craving sweet foods. 90%
(F)Age 73 History over many years of Irritable Bowel Syndrome and Chronic Fatigue Syndrome, also overweight. We treated her with FMT in December 2017, the Irritable Bowel Syndrome cleared up during the two months following the FMT and has remained normal. She is still having difficulty in losing weight. 60%
(F)Age 43 Several years history of Chronic Fatigue Syndrome. Also, Irritable Bowel Syndrome. We carried out FMT in January 2017, since that time the IBS has cleared up, energy significantly improved and has remained so. 70%
(F)Age 42 8-year history of Chronic Fatigue Syndrome. Also, Irritable Bowel Syndrome. We treated her with FMT in November 2018, I first saw her in May 2018. Since the FMT her persistent Oral Thrush has cleared, her digestion has improved, and the Irritable Bowel has settled down. She is no longer constipated. Her energy improved almost to normal following the FMT but has had a bit of a relapse since significant family upset, which has been draining on her energy reserves. 95%
(F)Age 73 Insomnia, persistent Nausea, poor energy due to Chronic Fatigue Syndrome, lack of appetite. Has lost a great deal of weight over several years. Complains of bad body odour. We carried out FMT in February 2017. Since then the Nausea has disappeared, the appetite has returned, and she is now putting on weight. 95%
(F)Age 46 I first saw her in 2016 with a history of Chronic Fatigue Syndrome and Fibromyalgia for several years. We carried out FMT in January 2017, no significant response to the FMT. We are thinking of repeating the FMT. 0%
(F)Age 66 At the age of 26 this patient contracted amoebiasis in the Himalayas, then she had lots of antibiotics for various indications and has had Irritable Bowel Syndrome and Chronic Fatigue Syndrome since the age of 30. Also, she has been diagnosed with SIBO and had developed multiple food sensitivities. We carried out FMT in July 2017, her Irritable Bowel Syndrome normalised over the next four weeks, her energy improved and became normal, then she had exposure to contaminated water, probably containing parasites, then she relapsed to some extent and had to have a second course of FMT in December 2017. Since that time, she has been completely normal. 95%
(F)Age 47 This patient has had regular courses of antibiotics since the age of 12 for a range of reasons. She has had many years of Chronic Fatigue and Irritable Bowel Syndrome. We carried out FMT in August 2018, since then the Irritable Bowel has settled down and the Chronic Fatigue has resolved. 90%
(F)Age 73 This patient has had a history of recurrent Candidiasis over many years, including Oral Thrush. She has many years history of Irritable Bowel Syndrome and Chronic Fatigue Syndrome. We carried out FMT on her in November 2018. Since that time, she has had no more Candidiasis, the Irritable Bowel has settled down, and there is significant maintained improvement in her energy levels. 85%
(F)Age 70 This patient has had a history over many decades of a Chronic Fatigue Syndrome. We used FMT in April 2017, there was no improvement in her energy levels since the FMT. 0%
(F)Age 70 Chronic Fatigue Syndrome for 20 years, also Addison’s Disease, Fibromyalgia and Irritable Bowel Syndrome. FMT carried out in August 2018. She reacted to several of the Implants with Diarrhoea, so we had to stop the Implants. Clinically, no change. 0%
(F)Age 61 20-year history of Chronic Fatigue Syndrome and Fibromyalgia, also Irritable Bowel Syndrome. Oral treatment did not work. FMT was carried out in April 2018. Following FMT her energy improved dramatically and has remained improved. The Irritable Bowel Syndrome has cleared up and she also lost one and a half stone in weight. 90%
(F)Age 41 Many years history of Chronic Fatigue Syndrome, multiple food sensitivities and Irritable Bowel Syndrome. FMT carried out in September 2018. She managed to tolerate half of the Implants and then temporarily had to stop. No clinical improvement yet. 0%
(F)Age 44 Eight-year history of Chronic Fatigue Syndrome getting significantly worse. Also, Irritable Bowel Syndrome. We carried out FMT on her in October 2018. Her Irritable Bowel Syndrome has cleared up completely, energy is beginning to recover. 75%
(F)Age 56 History of Chronic Fatigue Syndrome, Irritable Bowel Syndrome for many years. Resistant to oral approaches for treating both of these conditions. We carried out FMT in May 2018. Since that time her energy is significantly better, and remains better, bowel function is now normal. 80%
(F)Age 70 Chronic Fatigue Syndrome for many years, also Irritable Bowel Syndrome. We treated her with FMT in October 2017. Bowel habit is now normal, resistance to intercurrent infections has now returned to normal, energy was consistently improved and remains so. 95%
(M)Age 65 Chronic Fatigue Syndrome for many years. We treated him with FMT in November 2017. Energy has returned to normal. 95%
(F)Age 52 This patient has had Chronic Fatigue Syndrome for many years. Also, Irritable Bowel Syndrome. We treated her with FMT in July 2018. Since then, her energy has returned to normal and she has now been able to return to work, her gut has also returned to normal. 95%
(F)Age 48 History of Chronic Fatigue Syndrome and Irritable Bowel for many years. We carried out FMT on her in March 2018. Since then her Irritable Bowel Syndrome has cleared up completely and also her energy has returned to normal. 95%


The Standard or Oral Approach Group

The other group treated with nutritional remedies, probiotics, prebiotics, and dietary and lifestyle advice generally did improve – but not nearly to the extent that the fecal transplant group did.

Dr. Kenyon reported that most had improved by 30-40% (N=10), two people – one who had had ME/CFS for decades but improved rapidly on Dr. Kenyon’s regimen – improved by 90%, two by 50-75% and the rest with lesser improvements.

Dr. Kenyon, not surprisingly, concluded that fecal transplants are more effective at repairing gut flora than pre and probiotics. While two people responded poorly to the transplants, Kenyon reported they generally provide a safe and potentially effective approach to ME/CFS.

Fecal Transplants

That begs the question – just exactly what is a fecal transplant? It turns out that a variety of transplants are done. Some transplants transfer all the fecal matter while others filter out other components and only transfer the bacteria.

The Taymount Clinic reported that they implant only bacterial matter.  People who go the home route obviously transfer everything: get poop from a healthy donor, and then use saline solution and an enema to get the poop in (which they hold for as long as possible).

As might be imagined raw fecal matter contains all sorts of substances of which  bacteria make up just one component. Generally about 75% water and 25% solid matter, bacteria make up between 25-55% of the solid matter and 6-13% of the total matter. That’s a lot of bacteria – approximately one hundred billion per gram of wet stool – although only  3.0%–6.6% of total fecal matter may be composed of viable bacteria.

Some History

Other components found in fecal matter include significant numbers of epithelial cells that have flaked off the colon (colonocytes), single-celled organisms call archeae and other primitive organisms, viruses, fungi and metabolites.

Clostridium difficile

A Clostridium difficile outbreak in the U.S. caused doctors to search for alternative treatments

In the U.S.. fecal transplants have mostly been used to battle life-threatening Clostridium difficile infections. Transplants got a boost in early 2000’s after a particularly virulent form of C. difficile hit the U.S., causing gastroenterologists and patients to scramble for more effective treatments.  Six hundred and twenty-five thousand C. difficile cases are believed to occur in the U.S and Europe every year.

One women’s unstoppable C. difficile infection prompted her gastroenterologist to tell her, after seven months, to get her affairs in order. She ended up using her daughter as a donor in 2014. She reported:

“My gut drank up the infusion as if it were dying of thirst. My colon, after five months of near-constant spasms, recovered in one transformative instant. Overnight, I went from having 30 bowel movements a day to having one. For breakfast the next morning, I ate a quesadilla loaded with black beans, cheese, salsa, lettuce, and guacamole. I’ve had no recurrence of C. diff. since.”

Four pharmaceutical companies in the U.S. reportedly provide stool donors to doctors – mostly for C. difficile infections.  In 2016 the FDA’s decision to require stool banks to provide an expensive investigational new drug application (IND) in order to provide stool resulted in the agency being accused of erecting barriers to treatment which would result, among other things, in more unregulated, home use. Other less restrictive measures were proposed.

Although it’s believed that tens of thousands of fecal transplants have been done safely, the FDA recently reported for the first time that multi-drug resistant infections were transferred via fecal transplants to two people one of whom had died. The death occurred in a man with a compromised immune system who had been given a transplant which had not been screened for a type of resistant E. coli,. As a result, as of July 15th of this year, the FDA is requiring stool transplant companies to screen their poop for a variety of multi-drug resistant organisms.


The first stab at a fecal transplant study in ME/CFS was weak in statistics and strong in vivid detail. Dr. Kenyon’s fecal transplants – used mostly in ME/CFS plus IBS patients –  used only bacterial matter and were done in bulk – ten transplants over ten days – from different donors to ensure that a wide variety of flora was transmitted.

With seven of the 21 treatment resistant patients reportedly returning to full or near normal health, and six receiving significant improvements in energy, the results were surprisingly good.

While the results were promisingly we need more rigorous studies and one, funded by Invest In ME and lead by Peter Johnsen, a Norwegian researcher is underway. Data collection from the 80 person, randomized, placebo-controlled study at the University Hospital of North Norway started in February of this year and is slated to wind up in February of next year. I couldn’t tell how many fecal transplants would be given but changes in gut microbiome, metagenome, metabolome, gut barrier integrity and immune functioning will be assessed at three time points during the year long study.

Johnsen’s 2018 (n=86) study found that fecal transplants “provided significant symptom relief for people with IBS.  (In a nice bit of collaboration Maureen Hanson will be testing some of Johnsen’s samples for gut dysbiosis.)

POTS Rising! Research & Advocacy Producing Breakthroughs in Neglected Disease

April 28, 2018

Remarkable Progress

It’s rare that a clear cause of disease like postural orthostatic tachycardia (POTS) or chronic fatigue syndrome (ME/CFS) or fibromyalgia (FM) shows up, but that appears to be what’s happening in POTS.

focus - POTS

Researchers are increasingly focusing on autoimmune aspects of POTS

The progress is all the more notable in POTS given the newness of the disease.  The name was only coined in 1993 and the disease still lacks a dedicated funding stream at the NIH (but see below). Nor does the NIH track POTS funding the way it does other diseases.  It was only recently that the World Health Organization created an ICD code specifically for POTS. While the disease is mostly an afterthought at the NIH, it affects a large number of people (1-3 million in U.S.)

Despite its humble beginnings remarkable progress in understanding the disease is being made.  That’s good news for people with ME/CFS given the high incidence of POTS (11-40%) in the disease. Plus it shows that even a small research community can make significant strides in a disease if they target the right area.

Autoimmune Disorder

With its female dominance and often an infectious trigger, POTS, like ME/CFS, has always been a candidate for classification as an autoimmune disease.  In fact, autoimmunity has been showing up in orthostatic intolerance in general lately. Plus it’s shown up in an array of cardiovascular diseases including hypertension, cardiomyopathy, myocarditis and cardiac arrhythmias, each of which can cause problems standing.

Orthostatic Hypotension

It turns out there are many ways to mess with our circulatory systems.  A University of Oklahoma group has been driving the findings in mostly small studies. In 2012 that group reported that people with orthostatic hypotension, who experience severe drops in blood pressure while standing, commonly had autoantibodies to the receptors on the outside of cells that regulate autonomic nervous system activity. Remarkably, autoantibodies  were found in no less than 75% of the study participants.

The adrenergic (B1AR, B2AR) and muscarinic (M2R, M3R) receptors identified affected blood flow across the body. Different symptoms appear to result depending on which receptor is involved.

People with severe blood pressure drops within a few minutes of standing, for instance, tended to harbor B2AR and M3R autoantibodies which affect the vasodilation of our blood vessels. Because our blood vessels constrict or narrow when we stand in order to halt the gravitational flow of blood to our limbs, vasodilation during standing is exactly the wrong strategy.

Other people with dramatic heart rate increases while standing tended to harbor M2R and/or β1AR autoantibodies.


In 2014 the Oklahoma group’s study in the Journal of American Heart Association found evidence of three autoantibodies in POTS. This time the Oklahoma group predicted they would find autoantibodies to a receptor (α1 adrenergic receptor – α1AR) that causes our blood vessels to contract.

They found that, but in a twist, they also found additional autoantibodies: to the β1AR receptor in all the POTS patients, and vasodilatory autoantibodies to the β2AR receptor in half of them. They believe that these autoantibodies enhance norepinephrine’s effect on the heart; i.e. they increase the heart rate problems in POTS.

Autoimmunity POTS

Autoimmune processes that affect the blood vessels may define disorders that produce problems with standing.

They posit, interestingly, that problems with blood pressure not heart rate increases are the primary problem in POTS. They believe that when POTS patients stand, their α1AR autoantibodies smack the αIAR receptors, causing problems with blood vessel contraction. That allows blood to drain from POTS patients’ brains into their lower bodies causing fatigue, dizziness, etc. In order to compensate, they jack up their sympathetic nervous system activity with norepinephrine in order to maintain blood pressure.

Unfortunately, since POTS patients also harbor autoantibodies which cause them to increase their heart rates, the result is sometimes astonishingly high heart rates while standing. Since a heart beating too fast has the same effect as a heart beating too low (reduced blood flow), the ploy doesn’t work and POTS patients experience dizziness, fatigue, etc. upon standing.

In effect the POTS patients struck out on two levels; not only did they have autoantibodies that might be imperiling their ability to maintain their blood pressure while standing, they also had autoantibodies that dramatically increased their heart rates.

New Study – New Autoantibody

In a follow up 2018 study published in the Journal of the American Heart Association, the group looked at an entirely different type of autoantibody – the angiotensin II type 1 receptor (AT1R) that regulates blood pressure via the renin-aldosterone system. The renin-aldosterone system also regulates blood volume, which is often low in ME/CFS.

The study was again small (17 POTS patients) plus 16 controls, but once again the results were highly significant with 12/17 POTS patients but none of the controls exhibiting autoantibodies to AT1R. Plus all the POTS patients also had autoantibodies to either or both of the AT1R and the α1‐adrenergic receptor.

Because the renin-angiotensin-aldosterone system works more slowly than the aforementioned responses, it appears that many POTS patients may suffer from both a rapid and a more prolonged dysregulation of their circulatory systems.  When placed in a rabbit model, the ATIR autoantibody effectively duplicated the effects of the α1AR autoantibody – it stopped the blood vessels from constricting properly, again resulting in blood pooling in the lower extremities – and in humans feelings of fatigue, dizziness, etc.

In a nice fit, several POTS studies have documented problems with the renin-angiotension-aldosterone system, which could be caused by autoantibodies like ATIR. One study, which found elevated Ang II levels and low aldosterone levels, suggested that receptor problems were interfering with transformation of Ang II to aldosterone. The authors of this study suggested that the autoantibody found could indeed be the missing link.

Another Autoantibody (!)

We’re still not done with autoantibodies in POTS. A recent presentation which found a fourth autoantibody (to the M1 receptor) suggested POTS patients may be swimming in autoantibodies which negatively affect their circulatory systems.

Spectrum Disorder?

These investigators believe POTS is part of a spectrum of diseases (OH, POTS, cardiovascular diseases, (ME/CFS?)), all of which harbor autoantibodies that interfere with blood vessel contraction/dilation and the heart rate.

Dysautonomia International – Moving Forward on POTS

Since being co-founded in 2012 by Lauren Stiles, Dysautonomia International has grown rapidly and is now providing substantial funding for POTS research. A very dynamic organization, I was glad to have the opportunity to ask its President about its POTS work, where we are on autoimmunity and POTS, and DI’s recent advocacy work.

What kind of POTS funding has Dysautonomia International provided? 

Dysautonomia International

Dysautonomia International has grown rapidly in just five years.

Dysautonomia International has funded over $300,000 in POTS Research Fund grants to support the work of Dr. David Kem and colleagues at University of Oklahoma, exploring the role of autoimmunity in POTS, seeking to identify diagnostic biomarkers, and eventually the development of targeted immune therapies. Dr. Kem’s recent publication documenting the presence of angiotensin receptor antibodies in POTS was one of several important publications that resulted from these grants, and there are additional autoimmune POTS related studies still in progress at the University of Oklahoma. We have also funded autoimmune POTS related studies at Mayo Clinic and University of Texas Southwestern, which are in progress.

How far are we from establishing that at least a major subset of POTS patients have an autoimmune disease?

Most POTS experts acknowledge that a subset of POTS patients have an autoimmune problem. Defining what percentage of patients that is depends on how we define what we mean by “an autoimmune problem.”

For example, the largest cohort study on POTS to date with over 4,000 patients enrolled (lead by Dysautonomia International, Vanderbilt University and University of Calgary), found that 16% of POTS patients report being diagnosed with a known autoimmune disease, most often Hashimoto’s, Sjogren’s, lupus and celiac.

Then there is a larger group of POTS patients who have positive blood tests on common antibody tests, such as TPO, ANA or SS-A, but they don’t meet the criteria for a known autoimmune disease.

POTS patients have signs of an autoimmune disease but larger studies are needed to validate them.

Then we have several small cohort studies, usually 40 patients or less, showing that nearly all POTS patients have antibodies to various cell surface receptors that play a role in regulating the autonomic nervous system (adrenergic, muscarinic and angiotensin antibodies).

This last category of antibodies are also present in other medical conditions, several of which are associated with autonomic dysfunction, such as orthostatic hypotension, Sjogren’s syndrome, Chagas disease, dilated cardiomyopathy, and ME/CFS.

We need a lot of additional research before we can go from “we found these interesting antibodies that might play a role in POTS” to “we’re sure POTS is an autoimmune disease,” but that research is happening at several universities. The antibody tests are being refined. The small cohort studies are being repeated on larger cohorts. Researchers are starting to look at immune modulating treatments too.

I’m proud to say that Dysautonomia International is very much part of this effort, not only funding many of the studies, but also facilitating the larger cohort studies at our annual conferences, and connecting researchers who should be talking to each other together.

The NIH didn’t have a dedicated funding platform for POTS research but now things are looking up. What happened?

After Dysautonomia International’s July 2017 Lobby Day and our first Congressional Briefing on POTS in October 2017, Congress adopted our requested language directing the NIH to “stimulate the field’ of POTS research and “develop strategies that will increase our understanding of POTS and lead to effective treatments.” We’re continuing to meet with NIH to see what this will lead to in 2018, which we hope will be NIH’s first POTS specific call for proposals. Find additional details on our blog.


The POTS autoimmune finding are helpful for ME/CFS in several ways.  For one they show that researchers even in greatly underfunded diseases can make substantial progress if they target the right area. Secondly they’re beginning to demonstrate a strong autoimmune basis for a disease which produces similar symptoms to ME/CFS and which has a substantial overlap with it. Finally some of the same autoantibodies (and other ones) have been found in ME/CFS and interest in ME/CFS as an autoimmune disorder is picking up.  A recent review paper presented evidence that at least a subset of ME/CFS patients have an autoimmune disease. That will be covered in a future blog.

Hope for an ME/CFS Autoimmune Subset: A German Researcher Steps Forward

German Researcher Steps Up

Carmen Scheibenbogen MD is another sign that the ME/CFS field is slowly but surely hopefully catching on. Scheibenbogen is relatively new to this field, but she’s not new to medical research. A trained oncologist and hematologist as well as a physician and Professor of Immunology in Berlin, her research resume includes over 150 publications dating back 25 years.


Dr Scheibenbogen has identified what she believes is an autoimmune subset in ME/CFS. (Image from Invest in ME)

In short, she’s a respected and established researcher, and one from Germany to boot. (I can’t remember the last German researcher to take on ME/CFS.) Her path to ME/CFS has not been an easy one. Germany hardly acknowledges ME/CFS as a disease, and doesn’t fund ME/CFS research – if I’m reading her right, there is apparently literally no avenue to apply for ME/CFS research funding there.

Yet she’s very quickly become one of our most prolific researchers. Over the past four years her team has published no less than seven papers, has won two Ramsay Awards, and played a central role in the development of the new European Research collaboration, EUROMENE. Her biosketch lists CFS/ME, Immunodeficiency, and Cancer Immunology as her main research interests.

Scheibenbogen’s first ME/CFS publication In 2014 found ME/CFS patients mounting a feeble response to Epstein-Barr virus (EBV) . The reduced response to EBV reactivation could help explain the ups and downs seen, particularly during stressful situations.

In 2016, figuring that when Rituximab worked in ME/CFS it probably did so by whacking antibody producing B-cells, her group examined antibodies against a variety of receptors that affect blood flow, the autonomic nervous system, etc. They found that about 30% of ME/CFS patients in a large study (n=293) had increased levels of antibodies to adrenergic (B2) and/or muscarinic M3/M4 acetylcholine receptors (M3/M4).

That suggested that the immune systems of a significant subset of ME/CFS patients might be attacking the receptors on cells which regulate blood flow, lung functioning, muscle contractions and attention. Furthermore, the finding (a “remarkable” one they said) that the antibody levels of two receptors correlated with a host of immune factors (immunoglobulin levels, T cell activation, elevated ANA, TPO antibodies) suggested that this subset of ME/CFS patients are suffering from an autoimmune disease. Scheibenbogen has suggested that the kind of ME/CFS you have may be dependent on the kind of autoantibodies present in your system.

See Bad Bacteria, Brainstem Abnormalities and Progress with Rituximab: the Invest in ME Conference

Similar antibody findings have been found in a range of diseases (postural tachycardia, regional pain syndrome, Alzheimer’s, Sjogren’s syndrome, asthma) some of which have been associated with ME/CFS.

They also noted that immunoadsorption factors that are able to mop up these antibodies had proven to be helpful in some diseases. Two years later they put that idea to the test.

Possible Autoimmune Treatment

PLoS One. 2018 Mar 15;13(3):e0193672. doi: 10.1371/journal.pone.0193672. eCollection 2018.
Immunoadsorption to remove ß2 adrenergic receptor antibodies in Chronic Fatigue Syndrome CFS/ME.Scheibenbogen C1,2, Loebel M1, Freitag H1, Krueger A3, Bauer S1, Antelmann M1, Doehner W4, Scherbakov N4, Heidecke H5, Reinke P2,3, Volk HD1,2, Grabowski P1.


Adsorption vs absorption – By Daniele Pugliesi – File:Absorbimento e adsorbimento.svg, CC BY-SA 3.0,

They used a blood purification technique called immunoadsorption to eliminate the B2 antibodies from people with ME/CFS who’d had a post-infectious onset and high B2 antibody levels. Immunoadsorption (IA) was given five times over seven days to completely wash out the antibodies. Over the next six months the participants’ symptoms, muscle strength, endothelial functioning and immune factors were watched.


Significant improvement eventually followed by a relapse was the order of the day. One patient who could barely walk prior to the treatment was able to walk several hundred yards at the end of the IA process. She completely recovered for seven weeks and then relapsed. Another patient improved enough to go back to work but then relapsed. Five patients who improved started to relapse by the end of the six months. Three patients – a good third of the study – felt significant improvements in fatigue lasting at least 12 months.

The levels of all four antibodies (B1, B2, M3 and M4) declined after the treatment in all 9 participants. These are good results which are hampered by the small sample size and lack of a placebo control. Through our experiences with Rituximab, Synergy and Mirogabalin we’ve learned how little to trust early results.  Still, research has to start somewhere and the results thus far present hope for a significant subset of ME/CFS patients.

Present and Future Work

Ramsay Award Standout

The Solve ME/CFS Initiative (SMCI) provides funding to five or so researchers every year in its Ramsay Awards. The Awards are quite competitive with SMCI receiving far more applications than it can fund, but over the past two years the Scheibenbogen group has won two – the only group to do so.

2016 Award

Citing “ample evidence of an autoimmune pathomechanism” the Scheibenbogen team will be digging into the genetics of their “autoimmune subset”. They’ll be determining if genetic abnormalities in the enzymes or transcription factor that turn on the autoimmune processes are present. They’re also analyzing the immune cells (dendritic cells, regulatory B-cells) known to produce autoimmune responses.

This is one of the first times that I’m aware of that a research group has targeted a subset and dug deeper into it.  Scheibenbogen’s focus is clearly good news for people in that subset but it’s also good news for people outside of it. If she’s found a robust subset then it needs to be peeled off from other ME/CFS patients because it’s undoubtedly confounding study results for those patients.

2017 Award

The 2017 Ramsay Award will determine if T-cells and monocytes are up to the task in ME/CFS. We know that NK and probably T-cells are laggards in ME/CFS patients’ immune systems, but other immune cells are largely untested.

Following on recent findings of impairments in energy production, the Scheibenbogen group is going to determine if T-cells and monocytes have the energy to spring into action when needed. Immune cells are mostly quiescent until they come across a pathogen, at which point they’re required to rev up their engines and explode into action. If they don’t have the energy to “explode” they’ll have difficulty fighting off bugs.

If I have it right, they’re also going to stimulate cells using adrenergic and acetylcholinergic factors to see if they affect their metabolism or energy production. Given the role these factors appear to play in the deranged stress response found in ME/CFS, finding a metabolic tie-in would be exciting indeed.

Simmaron Scheibenbogen Collaboration Underway

The Simmaron Research Foundation is also working with Dr. Scheibenbogen to identify the subset of Dr. Peterson’s patients who fit the autoimmune profile, and to further characterize the subset from a clinical perspective.

A Leader

Over the past five years Scheibenbogen has become deeply immersed in ME/CFS. She was the lead author of a paper on the EUROMENE network, which contains researchers and clinicians from 17 European countries. Euromene was accepted into the COST (Cooperation in Science and Technology) framework which was established by the European Union to support collaboration in scientific endeavors. While COST does not fund research studies, it does fund networks and provides networking possibilities across the European Union.

EUROMENE members

EUROMENE members

One goal of Euromene COST Action is to establish a “sustainable integrated network of researchers in Europe working in the field of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and to promote cooperation between research groups.

Coordination and collaboration appears to be becoming a bigger and bigger theme. The OMF and the SMCI held collaborative and networking meetings last year. The NIH research centers are collaborating on one large project. Canada’s May Montreal conference is focusing on establishing cooperative efforts to understand ME/CFS. (Dr. Scheibenbogen will be attending.) The OMF’s next conference is set for September of this year.

However Dr. Scheibenbogen got interested in ME/CFS, it’s great to see her get so involved so quickly. She reminds me of another relatively new researcher in the field – Dr. Maureen Hanson – who quickly cranked out research studies and is now leading an NIH ME/CFS research center. It’s good to see new researchers have success in this field.

Of course, the going is still tough. In an SMCI interview Dr. Scheibenbogen seemed astonished at the lack of opportunities for research into what she described as a frequent and severe disease.

But still the situation is very disappointing with so little support for patients and research and almost no interest from pharmaceutical companies to perform clinical studies. I am a trained oncologist and hematologist and there the situation is so different with so much research and drug development.

Like everyone else in this field, Dr. Scheibenbogen is a pioneer and pioneers by definition have rough going. Like the pioneers of old she’s forging a path through some hostile territory, not as the pioneers did in the old West but this time German medical circles.  Her work is getting results, though, results that her colleagues will surely notice.  Here’s to a new presence in the field who’s put, perhaps for the first time, Germany – the most powerful nation in Europe – on the ME/CFS map.

Simmaron Celebrates 2016 & Matching Year-End Grant!

$100,000 Year End Matching Gift Opportunity: A generous donor will match your gift between now and December 31, 2016, doubling your impact!


Simmaron Powers the Rise of ME/CFS Science in 2016!

The last 18 months produced extraordinary change in the ME/CFS field, and Simmaron’s work has played a pivotal role. We could not have had such a strong impact without the generous support and participation of the ME/CFS community.

The publication of the Columbia-Simmaron spinal fluid studies in 2015 coincided with reports by The Institute of Medicine and the NIH Pathways to Prevention initiative to propel a transformation of the federal ME/CFS program. Columbia University’s work and our collaborations with them and others have put immunological research at the center of this renewal in ME/CFS science.

NIH Study to Replicate & Deepen Columbia Findings

NIH jpeg

A year ago, the Director of the National Institutes of Health announced a renewed commitment to ME/CFS research and the first intramural study of the disease in at least 20 years. The NIH study is designed to replicate Columbia’s findings with deep immunological, neurological and genetic testing. Advisors to the study include Dr. Ian Lipkin of Columbia University, Dr. Elizabeth Unger from the U.S. Centers for Disease Control, and recently Dr. Daniel Peterson.

A critical design element of the study is the criteria for enrollment, which requires “post-infectious” onset following the example set by Drs. Lipkin, Peterson and other clinicians in the XMRV study 5 years ago. Enrollment of controls has begun, and disease subjects will be enrolled early in 2017. Dr. Peterson and Simmaron are proud to have played a role in the strategic foundation of this unprecedented study.

NIH Funding Grows for ME/CFS

… NIH spending for research on the poorly understood disease should rise to roughly $15 million in 2017, doubling the estimated $7.6 million handed out in 2016.” Science Magazine

After years of advocacy by many patients, organizations and clinicians, the NIH is funding more ME/CFS centered research proposals. Science Magazine reports, “Vicky Whittemore, the agency’s CFS point person in Bethesda, Maryland, delivered on a promise that the NIH Director Francis Collins made last year by announcing that NIH spending for research on the poorly understood disease should rise to roughly $15 million in 2017, doubling the estimated $7.6 million handed out in 2016.” We hope this upward trajectory holds and brings increasing levels of federal research funding to our disease in years to come.

Simmaron is a collaborator in 3 NIH-funded grants and will continue to form collaborations that bring funding and excellence to our community.

Centers of Excellence

NIH has also announced that it will formally issue Requests for Applications in December to create one or more “collaborative research center” and data management center for the disease. Dr. Peterson, Simmaron and the broader community have long advocated for centers of excellence, and we hope these RFAs will be a strong step toward fulfilling that urgent need.

Simmaron’s work with Dr. Peterson and Sierra Internal Medicine has helped increase the impact of his 30-year center of excellence, by increasing the breadth and reach of his clinical research while he relentlessly seeks better care for patients.

5-year Anniversary5th-birthday-258x300

Simmaron celebrates 5 years of pursuing clinical research for ME/CFS and complex neuro-immune diseases with a goal of improving treatments for patients. In our short life, we have raised almost $2 million, and collaborated with Columbia University, CDC, NIH, Griffith University, SUNY-Albany, Open Medicine Institute, and Cornell University on immune-related research.

We are grateful for the generosity of our donors, the strategic vision of Dr. Peterson, the excellence of our collaborators, and the support of patients and volunteers who keep our program running. We believe the strategic vision of our research has, and will continue to, create the pilot data that is instrumental in guiding future research in the best direction, based on the unmatched clinical expertise of Dr. Peterson. We believe our strategy is solid and our impact great, and we have much more good work to do.

With your generosity, we can bring scientific answers to the ME/CFS disease and better treatments to neuro-immune patients. Thank you again for your treasured support.


Research Updates

While our early collaborations provided building blocks for an improved federal research program, our current studies seek to refine our scientific understanding of immune impairment, replicate new findings in the field, and generate data and leads for much needed medical treatments. The more research we do and fund with our collaborators, the more we will shape NIH’s new work and the future of patient care.

As the number of projects have increased, so too has our research team. The aggregation of copious amounts of biological specimens and clinical data requires intelligent and committed individuals. Our long-standing internship program has fulfilled much of this labor gap. In addition to helping us get the work completed, these internships allow college students to experience clinical research and modern medicine first hand.

Columbia Collaborations

Spinal Fluid Study, Phase I: Additional publications are in the writing and review stage to document additionPresentation1al findings from our ground-breaking spinal fluid collaboration with Columbia.

Spinal Fluid Study, Phase II:  The second phase of the Columbia spinal fluid study is in progress. The metabolomics portion of this study has been refined to seek replication of the recent findings published by Dr. Naviaux in the Proceedings of the National Academies of Science showing a hypometabolic state similar to “dauer” or hibernation.

Microbiome Study:  Simmaron is nearing completion of sample collection for Columbia’s microbiome study. A healthy gut microbiome is essential to immune function. Recent advancements in gene sequencing platforms allows understanding this essential environment to be much more feasible.

Exercise Tolerance and Immune Implications: Marked exercise intolerance, or one’s inability to recover from an exercise challenge, is a hallmark symptom of ME/CFS. Although immune perturbations after exercise have been identified in the blood of ME/CFS patients, no group has identified changes in the gut microflora before and after exercise, which this study will do.

Spinal Fluid Special Cases: Identifying subpopulations or subgroups of ME/CFS patients has been a primary goal of many researchers in the field. Our unique access to spinal fluid from hundreds of patients at Sierra Internal Medicine has been essential to this process. In this study we have identified several ME/CFS cases that later developed malignancies and autoimmune diseases. We hope that this study will further delineate subpopulations of this very heterogeneous population.

Spinal Fluid Lymphoma Project: Dr. Peterson and Columbia have designed this project to further characterize and study his patients who have developed Lymphoma. The study is designed and in progress.

CDC Collaborations

CDC Multisite Clinical Assessment of ME/CFS: Simmaron is preparing for Year 5 work on this 7-site collaboration. cdc-logoThe CDC study is the largest study of ME/CFS, collecting data and samples from more than 800 patients and controls selected and diagnosed by top clinical experts in the country. The first manuscript from the study is currently under review for publication.

Data Analysis of Immune Measures During Treatment: Simmaron is collaborating with CDC to analyze patient data from treatments at Sierra Internal Medicine.

Other Important Collaborations

Autoimmunity and Non-Hodgkins Lymphoma in ME/CFS: In collaboration with SUNY-Albany, Simmaron is studying the incidence of autoimmune diseases and lymphomas in families of ME/CFS patients. The study is nearing completion.

Arthropod-Borne Disease in Post-Infectious Fatigue:  Simmaron is collaborating with Coppe Healthcare Solutions (formerly Wisconsin Viral) to identify the incidence of vector-borne pathogens in the cohort of ME/CFS patients and controls biobanked during the federal XMRV study.

Genomic and Functional Analysis of Immune Receptors in CFS: This collaboration with Dr. Barao at University of Nevada Reno seeks to identify whether genetic variations in the genes coding for immune receptors play a role in ME/CFS. This study is ongoing.


Hear More on Tuesday about NIH study during CDC’s Grand Rounds

NIH jpegOn Tuesday, February 16, at 1:00 East, Dr. Avindra Nath, the Principal Investigator of NIH Clinical Center’s study of post-infectious ME/CFS, will make a presentation about the first intramural study of our disease in 20 years. This is a well-timed opportunity for patients to hear Dr. Nath describe the study in some detail. (Webcast link is on this page, right hand side: )

The study at the NIH Clinical Center is designed around a subset of patients with post-infectious onset, similar to recent studies led by Drs. Ian Lipkin and Mady Hornig at Columbia University, studies Simmaron knows well as a collaborator. It is part of a renewed commitment to research ME/CFS announced by NIH Director Dr. Francis Collins in October, when he talked about an intramural study on patients who became ill following an infection.

We encourage patients to watch the webcast of the CDPublic Health Grand Rounds_180x150C Grand Rounds to hear directly from Dr. Nath. He is an infectious neurologist, with experience ranging from AIDS and HIV to studying many infectious agents in collaboration with Dr. Lipkin’s Center for Infection and Immunity.

The CDC Grand Rounds presentation is made to a broad audience of doctors and practitioners throughout the medical community. This event is focused on ME/CFS (for the first time) to educate medical professionals about the new IOM diagnostic criteria, have them hear from expert clinician Dr. Charles Lapp, and describe the NIH’s intramural study. Organized by CDC’s Dr. Elizabeth Unger, we also look forward to hearing data describing the physical severity of the disease from the CDC’s multi-site clinical study, in which Simmaron and other expert clinics are participating.

Last weekend, a draft protocol for the NIH intramural study was posted which did not completely describe the selection criteria. While it was clear about enrolling patients that developed the disease following an acute infection, it mentioned use of Reeves criteria, which raised concerns among patients.

Dr. Avi Nath

Dr. Avindra Nath, NINDS Senior Investigator

A couple days later, Dr. Nath and NINDS Director Dr. Walter Koroshetz provided important clarifying information to Bob Miller and me, especially noting that enrollees will need to meet the Canadian Consensus Criteria and have Post Exertional Malaise. They said additional information will be posted on a website for patients and the community in the coming week. We wanted to reiterate them here for patients who are able to watch the webcast.

We asked questions about the criteria for enrollment, reference to Reeves criteria in the draft protocol, role of ME/CFS experts and the choice of control groups. According to the principal investigator of the study, Dr. Nath:

  • Enrollees will meet all definitions for ME/CFS, including Canadian Consensus Criteria, IOM, Fukuda and Reeves, in addition to post-infectious onset.
  • Post-exertional malaise (PEM) is a criteria, and will be specifically studied with extensive testing before and after exercise challenge.
  • Dr. Ian Lipkin of Columbia University’s Center for Infection and Immunity has been advising the investigators on the study design and protocol.
  • Expert clinicians will be used in patient selection, including those participating in recent multi-site studies of ME/CFS. This information was also learned separately by MEAction.
  • Control groups: Asymptomatic Lyme was chosen to contrast post-infectious ME/CFS patients to patients who recovered from an infection. Functional Movement Disorder was chosen to contrast post-infectious ME/CFS patients with a very well-studied group of patients with clear psychological illness with neurological presentation.
  • They seek to have 40 PI-ME/CFS patients, and they will study them longitudinally, hoping to learn how and whether the disease changes over time.
  • Testing will be extensive.

Personally, Bob and I are very excited to know that the NIH intramural study is moving forward, and that it will deeply study patients with infectious onset against a battery of biological tests. We are reassured by these details, and eager to have this kind of data to move our disease toward discovery.

The webcast is at 1:00 Eastern Time, Tuesday February 16, and the link to view the webcast is here:

Simmaron Powers Change in 2015 & You Power Simmaron!

Simmaron Powers Change in 2015

2015 marks a powerful turning point for ME/CFS patients,

and it’s all happening because of you!

“We are going to ramp this up.’”

Dr. Francis Collins, Director, National Institutes of Health

NIH Elevates ME/CFS Research!

On October 29, Dr. Francis Collins, Director of the National Institutes of Health, announced promising changes to the federal research program on ME/CFS. He moved leadership of the disease to the National Institute of Neurological Diseases and Strokes, will upgrade the Trans-NIH Working Group to institute decision-makers, and will initiate an in-depth study of patients at the NIH Clinical Center in early 2016. Dr. Collins’ personal quotes mark the change: “‘…we ought to be able to come up with an answer with the tools we have.”

Dr. Ian Lipkin, Columbia University

“…it means it’s moved toward the front of the stove.” Dr. Ian Lipkin

One important catalyst to NIH’s promising changes was publication of the Columbia study findings this Spring. Two publications – the CFI multi-site study and Simmaron’s spinal fluid study – document groundbreaking findings of immune abnormalities, and they coincided with game-changing recommendations from the prestigious Institute of Medicine and NIH Pathways to Prevention Program identifying the “urgent need” for ME/CFS research. Simmaron is a proud collaborator in multiple Columbia studies, including our signature spinal fluid studies which distinguish ME/CFS patients from those with Multiple Sclerosis. As we move the pace and quality of research up, our Columbia collaborations become even more important.


Obama and Courtney questionPatient advocates led the community’s work to move ME/CFS from the fringes into the NIH Director’s office. Robert Miller and his wife Courtney, who volunteers as Simmaron’s Board President, have worked with many people for years to engage patients in direct actions, email campaigns and high level federal meetings, even provoking a promise from President Obama to elevate research at NIH. Patients have sent thousands of emails to FDA, NIH, and Secretaries of Health in recent years, and engagement of patients and experts was critical to a strong outcome from both the IOM and P2P processes. Many patients and groups contributed so much to garner recognition, and we know there is still a long way to go. We congratulate all patients who are central collaborators in the scientific advancement and social movement that created this shift.

With your help, Simmaron will continue to advocate for a strong federal research program with an emphasis on immunological dysfunction and the need for treatments.


Help Us Continue Columbia Collaborations!

SR_Donate_6.9.14_1Help us continue collaboration with Columbia University’s Center for Infection & Immunity at the Mailman School of Public Health. Simmaron’s priority is pursuing the next generation of spinal fluid studies with Drs. Lipkin and Hornig, to generate more specific information so we can translate findings into potential diagnostics and treatments.

  • Luminex, Proteomic and Metabolomic Discovery in Cerebrospinal Fluid of Patients with CFS/ME, Phase 2: Begun in 2015, this 2-year study is phase 2 of the Columbia spinal fluid studies. Proteomics will be used for biomarker identification and metabolomics to study bacteria and fungi-produced chemicals that enter systemic The 2-year cost of this study is $425,000, of which $273,000 has been funded. These are expensive studies because of the technologies and broad scope of investigation, but their potential to change the focus of research nationally and contribute to future treatments is enormous. We need your help right now: our immediate goal is $32,000 to complete first year funding!

In addition, Simmaron is collaborating in the Columbia Microbiome study, which is moving into the analysis stage. Dr. Hornig visited Simmaron in August and talked about the continuum of our studies together. Cort Johnson wrote: “Dr. Hornig noted Dr. Peterson’s exceptional foresight at collecting cerebrospinal fluid samples over many years and his skill at characterizing them. Now she appeared almost dumbfounded at his ability to pluck out subsets in his patients.” (Read Cort’s full blog here ).


Data Extraction and Analysis: Now is the Time!

Simmaron Research | Give | Donate | Scientifically Redefining ME/CFSGiven the changes announced at the highest level of NIH, now is the time to provide the historical experience of one of the field’s most experienced clinicians to inform new approaches at NIH. Simmaron has a unique ability to work with Dr. Peterson to extract data from his richly characterized patient cohort, but we need your help to make it feasible.

  • Data Extraction and Analysis: Simmaron has unparalleled data from Dr. Peterson’s clinical experience monitoring immune testing and utilizing immune-based treatments. We seek funding to extract and statistically analyze clinical experience with treatments to publish and share data that will stimulate more clinical trials in ME/CFS. Cost: $100,000 for 2016.


Our Special Thanks to the Spearing Family

thank you clip artLast May, the Spearing Family spearheaded a fundraiser to promote scientific research to help their daughter Stephanie, who suffers from a severe case of ME/CFS. They honored Simmaron Research by urging friends, family and others to support our research work. Dad rode in a 100-km Tour de I’lle de Montreal cycling event to raise funds for Simmaron, and his dedication was matched by gifts from many who know them. Every effort to support our work – from individual contributions to hosting fundraisers and helping spread the word – is critical to our ability to do the science that makes a difference. Please contact us ( ) if you have an idea we can help you with!


You Power Simmaron and the Rise of ME/CFS Science

Simmaron is continuing to collaborate on the following studies with a select group of collaborators:

  • Autoimmunity and Non-Hodgkins Lymphoma in ME/CFS: This study evaluates the family history of autoimmunity and the increased prevalence of Non-Hodgkins Lymphoma in patients with ME/CFS. It is led by the University of New York Albany and collaborators include Dr. Paul Levine and Dr. Daniel Peterson.
  • CDC Multi-Site Clinical Assessment of ME/CFS – Year Three: Sierra Internal Medicine is collaborating in the CDC’s 7-site clinical assessment of chronic fatigue syndrome (CFS) to characterize patients with CFS or myalgic encephalomyelitis (ME) in clinical practices of clinicians with expertise in ME/CFS. The data collected will be used by CDC to address the CFS case definition and to improve how to measure illness domains and subsets.
  • Microbiome Study in ME/CFS: The Center for Infection and Immunity at Columbia University is conducting a study of the gut microbiome in a subset of patients from Lipkin and Hornig’s pathogen investigation in ME/CFS, including patients from Sierra Internal Medicine.
  • Arthropod-Borne Disease in Post-Infectious Fatigue: Simmaron was awarded samples from the NIH directed XMRV investigation to study the presence of antibodies to vector-borne pathogens in highly characterized CFS/ME patients and controls. This study recently got underway. It has the potential to aid in subsetting and identifying a role of infection in precipitating CFS/ME. Collaborators include Wisconsin Viral and Sierra Internal Medicine.
  • Genomic and Functional Analysis of Immune Receptors in Chronic Fatigue Syndrome – Part 1. Isabel Barao at University of Reno Nevada will determine whether genetic variations in the genes coding for immune receptors expressed by natural killer (NK) cells, macrophages and B cells, play a role in chronic fatigue syndrome (CFS) risk and pathogenesis. Collaborators include UNR, National Cancer Institute, and Sierra Internal Medicine.
  • Data Analysis of Immune Measures in ME/CFS Patients: Simmaron is extracting and analyzing data from patients at Sierra Internal Medicine to correlate immune measures with treatments and outcome measures.
  • Nested Pathogen Study in Cancer Subset of ME/CFS: This investigation parallels the Columbia University study described above, studying the cerebral spinal fluid of a subset of ME/CFS patients who went on to develop lymphoma or other cancers.

We are powered by your continued support. We thank Drs. Lipkin and Hornig at Columbia for pursuing the science of our disease, and we are honored to collaborate with them. We are equally proud to collaborate with the CDC, NCI, UNR, University of NY Albany, Coppe Healthcare Solutions and Cornell. We are indebted as a community to Dr. Peterson for envisioning ground-breaking spinal fluid studies and pushing for immunological research and treatments. We praise all patients, experts and advocates for tireless work to elevate the federal research program on ME/CFS.

Simmaron is proud to contribute to the rise of ME/CFS science, and we are moved by the knowledge that the more we do now, the sooner the scientific community will fully embrace our disease.

SR_Donate_6.9.14_1Simmaron’s results are made possible by generous donors like you. YOU have the power to change patients’ lives.


ACT NOW: Just Say NO to Funding Cuts for ME/CFS Research

ALERT: Senate Cuts CDC’s funding for CFS to Zero, gutting 50% of federal research funding for ME/CFS

NO Funding Cuts:  One Clear, Consistent Demand for Equal Funding

By Cort Johnson and Robert and Courtney Miller

While patients advocate for Equal Funding for ME/CFS research, the Senate Appropriations Subcommittee quietly zeroed out CDC’s budget request for CFS research.

One of the studies to be cut would be the CDC’s Clinical Assessment or Multi-site study. Dr. Peterson had this to say about that study:

“The CDC’s clinical assessment study is pivotal to patients with CFS/ME allowing CFS clinicians to analyze our ‘classic’ patients for commonalities, subset distinctions and biological markers in a collaborative manner. The last few years of this work with Dr. Unger and the CDC staff has increased our understanding and evolved the spectrum of collaboration. Many more resources are required to expand on recent scientific findings.”    Dr. Daniel Peterson, Sierra Internal Medicine and Simmaron Scientific Advisor

Patients with ME or CFS only have two choices right now: either we go forward with one clear demand for Equal Funding for federal scientific research – which means no cuts! – or we go backwards. We need your action to restore precious funds!

We should be going forward now. Institute of Medicine profiled the “urgent need for more research” in February. In June, National Institutes of Health’s Pathways to Prevention Panel said “innovative biomedical research is urgently needed….” Columbia University published groundbreaking patterns of immune abnormality. CDC just published new findings of gene variants in the immune and inflammatory pathway of patients.

500 patients and caregivers wrote the Secretary of Health and Director of NIH in May highlighting these independent reports and demanding that research into our illness be funded equally with Multiple Sclerosis or Systemic Lupus, at more than $100 million per year. Sen Zero for CDC CFS

Meanwhile, the Senate Appropriations Subcommittee quietly zeroed out the only earmarked funding for CFS in any health agency budget: they crossed $5.4 million out of CDC’s proposed budget and put “0” next to CFS.

NIH is watching this closely. NIH only spent $5 million last year on CFS research. Why should the NIH fund ME/CFS at $100+ million, when Senate appropriators can get away with removing funding for the only line item ME/CFS patients have in the federal budget?

This cut isn’t about CDC’s bad history with CFS. It’s about whether or not ME/CFS patients will protest in one voice that it is time to fund us equally.

Huge ME/CFS Study Put in Jeopardy

At the heart of the CDC’s ME/CFS program lies one of the largest ME/CFS studies ever undertaken – the Multi-site (Clinical Assessment) study created by Dr. Andy Kogelnik.

We believe this project provides a distinct and welcome turning point for CDC’s CFS program.

We have watched closely as the CDC collaborates with CFS/ME experts like Dr. Daniel Peterson, Dr. Nancy Klimas and Dr. Andy Kogelnik. For the past 3 years, seven expert doctors have been collaborating with CDC’s Dr. Unger to study patients selected and diagnosed by the doctors, collaborating on what diagnostic markers to test, under what conditions, across 7 clinics, for consistency, new data and a different future.

The study will help inform efforts to create a new definition, uncover subsets, produce new diagnostic guidelines, understand the course of the disease, and introduce to the public for the first time, treatments ME/CFS experts use to enhance the health of their patients.

Phase II of the study, underway now, will, also for the first time, ever assess large numbers of severely ill patients. The study also includes a large exercise study that will assess the effects of exercise on lactate levels, gene expression, cognition and symptoms.

This study will end if the Senate’s budget stays at 0 for the CFS program. That would be tragic.

Take Action

Please make it clear to the Senate Appropriations Subcommittee that ME/CFS patients deserve equal funding, not funding cuts. Cutting $5.3 million from CDC’s budget would cut federal research funding in half. That is going backwards for patients.

The question is for us as a community is whether we are going to allow anyone, on the heels of the IOM and P2P reports, to cut any part of the budget for ME/CFS. In order to be successful later we must take a stand now and say no to this bizarre attempt to cut the ME/CFS research budget in half. ME/CFS support organizations (including Solve ME/CFS, the IACFS/ME, the Open Medicine Foundation, Simmaron Research, Mass CFIDS/ME, New Jersey ME/CFS and Conn. CFIDS/FM) have created their own letter and other efforts are underway to get doctors and researchers to protest this untimely cut to ME/CFS research.

Take Action with this Email Template:

Please email these senate committee staff and YOUR Senators. You can copy and paste the text below or change it as you see fit:

AND your senators – find them here:


SUBJECT:       Restore Cuts to Chronic Fatigue Syndrome Funding in CDC Budget


Dear Senate Appropriations Committee:

I am very ill with Chronic Fatigue Syndrome (known as Myalgic Encephalomyelitis). We have suffered with the smallest budget at CDC and NIH for decades. I am distressed to learn that the Senate Appropriations Subcommittee has cut CDC’s budget on Chronic Fatigue Syndrome research to zero, and I need you to restore it to the same level as the House bill in the Conference Committee. (see: pg 59)

This year, two independent panels of scientists – the prestigious Institute of Medicine and National Institutes of Health’s Pathways to Prevention Panel – both reported the same urgent need: “There is an urgent need for more research to discover what causes ME/CFS, understand the mecha­nisms associated with the development and progression of the disease, and develop effective diagnos­tic markers and treatments.”

I am disabled by CFS and I deserve equal funding, not zero funding. More than 1 million Americans have CFS, costing the US economy more than $20 billion annually. CFS is as disabling as late-stage renal failure and Multiple Sclerosis. There are no FDA-approved treatments or diagnostic tests. I want my life and health back, and I need medical research to solve my disease.

Cutting CDC’s $5.3 million request reduces federal research funding for CFS by 50% at a time when we desperately need more scientific research. Please restore the CFS budget request and urge NIH to fund CFS research equally with Multiple Sclerosis.



Years Ill:

City and State:

Institute of Medicine Issues New Diagnostic Criteria and Disease Name

New Diagnostic CriteriaIOM_MECFS_hi res cover

Yesterday, the Institute of Medicine released its report establishing new diagnostic criteria for ME/CFS. The new definition requires post-exertional malaise, a physical hallmark of the disease that ME/CFS experts have advocated as a core diagnostic criteria. The new criteria are less complicated than previous definitions, while requiring symptoms that are specific to the illness. Clarity in the definition and wide dissemination of the new diagnostic criteria should improve a tortured process of diagnosis for patients.

The IOM report has received broad coverage in mainstream media, and both the Journal of American Medical Association and the Annals of Internal Medicine published the Chair of the Committee’s editorial outlining the definition and the case for stronger response in the medical community.

The San Francisco Chronicle quoted Dr. Jose Montoya saying, “The report ‘has the potential to change the narrative of this disease,’ Montoya said.”

Diagnostic Criteria:

Proposed Diagnostic Criteria for ME/CFS Diagnosis requires that the patient have the following three symptoms:

1. A substantial reduction or impairment in the ability to engage in pre-illness levels of occupational, educational, social, or personal activities, that persists for more than 6 months and is accompanied by fatigue, which is often profound, is of new or definite onset (not lifelong), is not the result of ongoing excessive exertion, and is not substantially alleviated by rest, and

2. Post-exertional malaise,* and

3. Unrefreshing sleep*

 At least one of the two following manifestations is also required:

1. Cognitive impairment* or

2. Orthostatic intolerance

 * Frequency and severity of symptoms should be assessed. The diagnosis of ME/CFS should be questioned if patients do not have these symptoms at least half of the time with moderate, substantial, or severe intensity.

The Committee also recommended that the diagnostic criteria be revisited in no more than 5 years to incorporate new findings in scientific research on the disease.

Recommends New Name:  Systemic Exertion Intolerance Disease

Fatigue is out of the name. The IOM Committee recommended changing the name of the disease, stating the following:  “The term ‘chronic fatigue syndrome’ can result in stigmatization and trivialization and should no longer be used as the name of this illness.”

Disease is in. The new name proposed by the IOM is Systemic Exertion Intolerance Disease, SEID. “This new name captures a central characteristic of this disease—the fact that exertion of any sort (physical, cognitive, or emotional)—can adversely affect patients in many organ systems and in many aspects of their lives.”

Emphasizes Urgent Need for Research

From the IOM Report:

“Remarkably little research funding has been made available to study the cause of ME/CFS, mechanisms associated with the development and progression of the disease, or effective treatment, especially given the number of people affected….Finding the cause of and cure for ME/CFS may also require research on large numbers of ME/CFS patients, from which important subsets can be identified (for example, variations in symptoms, response to physical and cognitive stressors, brain imaging, the microbiome, virology, immune function, and gene expression). Studies assessing the natural history of the disease and its temporal characteristics—onset, duration, severity, recovery, and functional losses—are essential for a better understanding of ME/CFS. The committee stresses that more research is urgently needed.”


IOM Powerpoint outlining its findings and recommendations.

IOM Key Facts, noting the prevalence, severity, cost of the disease to the U.S., and the specificity of Post-exertional Malaise in identifying ME/CFS patients. “There is an urgent need for more research to discover what causes ME/CFS, understand the mechanisms associated with the development and progression of the disease, and develop effective diagnostic markers and treatments.”

IOM Report Brief, a 2 page summary of the report.

IOM Report, “Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness”, 304 pages.

Journal of American Medical Association Opinion by Ellen Wright Clayton, Chair of the IOM Committee on ME/CFS

Science Magazine

New York Times Blog, David Tuller

Washington Post

PBS Newshour

San Francisco Chronicle

Cort Johnson, Health Rising

Simmaron thanks the members of the IOM Committee for their work, patients and caregivers who gave input, and Simmaron’s Scientific Advisor Dr. Daniel Peterson for being a reviewer of the report.

NIH P2P Draft Report and Videocast

NIH Pathways 2 Prevention Draft Report on ME/CFS is Available

Tonight, the NIH Pathways 2 Prevention Panel on ME/CFS posted its draft report.

It recommends a network of collaborative centers for translational care, NIH collaboration in clinical trials, research emphasis on immunological, neurological and genetic impairments, broad physician education, and clearly articulates that ME/CFS is a physiological illness, not psychological.

You can read the draft report here.


Videocast of the NIH P2P Panel: Advancing the Research on ME/CFS

12/9/14 Day 1 Videocast

12/10/14 Day 2 Videocast

You can fast forward through different presentations. To find the agenda to guide you to parts you want to see, go here.