All posts by Courtney Alexander Miller

Help Simmaron AMPlify therapies for M.E.!

Simmaron is fundraising for its one-of-a-kind study to analyze data from ME/CFS patients who respond to treatments like Ampligen®, IVIG, and cidofovir. The goal of the study is to build a scientific roadmap for getting a first medication approved by the FDA for our disease.

Which patient subset responds to immune-based treatments, like Ampligen and IVIG?

Or anti-viral treatments like cidofovir?

Which subset responds to saline or amino acid infusions?

What measures demonstrate response?

These therapies are currently in use at Sierra Internal Medicine in Incline Village under individualized treatment plans by Dr. Daniel Peterson, and Simmaron’s role is to compare the results of 3 different treatment groups in a prospective analysis that can give us clues to measuring treatment response vigorously.


Simmaron is collaborating with Maureen Hanson, PhD of Cornell, who will lead scientific research on patient samples; the US Centers for Disease Control, which will lead statistical analysis; and Sierra Internal Medicine, where patients receive the treatments.


The funds we raise will pay for data extraction, analysis, and sample preparation to study who responds, what markers track improvement in how patients feel, and what characteristics can be used to refine patient enrollment in double-blind trials. The funds are not covering individuals’ costs for the treatment itself.

The study has a budget of $200,000, and some of the elements have secured funding from generous donors so far. We have a goal of raising $20,000 during this fundraising effort!

The Data Study

The Responder Study takes advantage of an unfortunate year-long hiatus in availability of Ampligen, meaning that the patients are being tracked from a baseline of not having that treatment for more than a year and the functional decline that came with the hiatus.

The study will include 13 patients who resume Ampligen, 13 who receive other intravenous therapies, and 13 patients who receive no infusion-based treatments, matched for age and sex.

Our research team will track the following measures before, during, and at 52 weeks for the different treatment arms:

  • NK cell (natural killer cell) function
  • Cytokine expression
  • Multiple symptom surveys
  • Exercise tolerance test
  • Cornell-designed research protocols

Gunnar Gottschalk, Simmaron Research Fellow, describes the urgency of this study, “It is imperative that we publish findings that track an individual’s response to therapy in order to understand this patient population more completely.”

NIH Presentation

During NIH’s recent workshop for Young ME/CFS Investigators, Gottschalk presented on the clinical experience of 25 patients treated with Ampligen from 2011 to 2017 at Sierra Internal Medicine. The presentation showed “…significant and sustained clinical reduction in both the physical and neurological symptoms following Rintatolimod (Ampligen®)”, including improvement in physical functioning, pain and energy after 6 months of treatment.

Poster Presentation at NIH Accelerating Research for ME/CFS Scientific Conference, April 2019

Informing A Pathway to Approval

We know first-hand that patients need well-designed treatment trials to achieve FDA approval for a first ME medication. Rigorous data analysis, starting with this study, can provide a building block to designing rigorous placebo-controlled trials that have a stronger chance of approval, and ultimately attract pharmaceutical companies to the disease.

Simmaron is leading the effort to turn science into treatments for patients, and your support powers our work. Help us reach our goal of raising $20,000 in the next month to fund an important part of this study!

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.


Simmaron’s Lucky Duck Donation

We have a great story from a Simmaron donor, and we hope you get a kick out of it.rubber-duck-sea

Incline Village, home to Simmaron Research, is also the site of a fantastic 4th of July celebration, with myriad festivities of all kinds for all ages. Fan favorite highlights are the annual the rubber duck races, offered by Incline Village Rotary, where (human) entrants can sponsor a traditional yellow rubber duck for $10 or splurge on a platinum duck for $100.  Then, a sea of rubber ducks race to win at a Lake Tahoe beach. The winning “pot” is divided between the Rotary Club for its charitable endeavors, and the duck’s sponsor.

This year’s winning platinum duck (as it happens, lucky duck #13), had been purchased by Dana Rieger.  When Dana signed up to participate at the Rotary table, she turned to her husband Steve and said, “my duck is going to win and I’m going to give the money to Simmaron!”

Simmaron's Lucky Duck!

Simmaron’s Lucky Duck!

Sure enough, her duck was victorious, and she contributed the $2200 winnings to support Simmaron’s efforts to scientifically redefine ME/CFS.   The Riegers are parents of a housebound ME/CFS son, a grateful patient of Dr. Peterson.  The family has been supporters of Simmaron over the last three years.

Simmaron Research is grateful for the ongoing support we have received from the Rieger family and many donors like them, who seek progress and answers for loved ones with ME/CFS. The lucky duck race is one way that Simmaron has become part of the fabric of our community, and we are honored – and amused – at how this donation made its way to world class research!SR_Donate_6.9.14_1

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.