Same Mission | New Name

May 30, 2014

Solve ME/CFS Initiative

We’re delighted to announce that The Solve ME/CFS Initiative has a new name – the Solve ME/CFS Initiative.   While our name has changed, our mission steadfastly remains the same:  We will make ME/CFS understood, diagnosable and treatable.

Why the change?  We recognize the many changes in our organization and our illness space since the organization was first named so long ago in 1987.  While the name of our illness continues to be controversial, “ME/CFS” better reflects today’s understanding. And we believe that the word “initiative” (defined as ‘leading action’), expresses our strong commitment to funding ground-breaking research.

Since our organization was founded and named in 1987, we have been the leading organization focused on this illness.  Over the years, we’re proud of our remarkable advances regarding this controversial and misunderstood disease.

  • Under the 22-year leadership of Kim McCleary, the organization’s first CEO, the Association played an integral part in developing a policy ruling for the Social Security Administration that recognized CFS as a disabling condition.
  • We are the leading private funder of ME/CFS research, directly funding $5.5 million in ground breaking research which has been leveraged into more than $12 million in additional ME/CFS research.
  • The organization fought to create and continues to advocate to sustain a dedicated federal advisory committee on ME/CFS research and education (CFSAC).
  • We helped expose the misappropriation of $12.9 million in CDC spending, restoring these funds to ME/CFS research.
  • We led the first-ever public awareness campaign for ME/CFS, led lobbying events, organized Congressional briefings and regularly deliver testimony at numerous federal hearings and meetings.

Four years ago, guided by a desire to move into a new era of scientific progress on ME/CFS, the Association made a strategic decision to heighten its focus on research.  Our thinking was simple – the best way to use our precious dollars is toward solving this despicable illness.

Today, led by President and CEO, Carol Head, the organization continues to drive its mission forward – to fund research that will make ME/CFS understood, diagnosable and treatable.  How do we do that? By providing more funding for high-quality ME/CFS studies, fostering increased collaboration among ME/CFS researchers and pushing the federal government to make ME/CFS research a higher priority.  We are working to leverage our experience, relationships and collective knowledge to propel the ME/CFS research field forward. We are a catalyst for scientific advances that translate into better care for ME/CFS patients. We are accelerating ME/CFS research.

As we continue our efforts to make ME/CFS widely understood, diagnosable, and treatable, it is fitting that we have a name that more accurately reflects who we are: The Solve ME/CFS Initiative. We trust that you will continue this journey with us as we work towards a day when ME/CFS is no more.

 

What Will CFSAC Look Like in 2017?

January 20, 2017

2017-1

January’s meeting was technically the concluding meeting of 2016, as a second meeting was not convened last year. Commander Gustavo Seinos, the designated federal officer assigned to coordinate CFSAC, announced there will be at least two additional CFSAC meetings in 2017. All CFSAC business is publicly available and governed by the Federal Advisory Committee Act.

For more information about CFSAC and its role in the federal government, go here.

As of January’s CFSAC meeting, five newly created CFSAC voting member positions remained unconfirmed and one additional position still requires a solicitation of applications. Additionally, several members currently serving in voting positions will reach the end of their terms in May; new applications for these positions will need to be solicited. Additionally, SMCI requested that additional agencies be included in CFSAC. As a result, new ex officio positions (government agency staff assigned to participate in CFSAC) are to be added. So there will be many new faces on CFSAC in 2017.

Chronic Fatigue Syndrome Advisory Committee (CFSAC) Meeting Summary

January 20, 2017

CFSAC MeetingOn January 12 and 13, the Federal Chronic Fatigue Syndrome Advisory Committee (CFSAC) met for one of its biannual meetings in Washington DC. CFSAC works to provide advice and recommendations to the Secretary of Health and Human Services (HHS) through the Assistant Secretary for Health on issues related to myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).

This meeting included a final presentation from outgoing Assistant Secretary for Health Karen DeSalvo, who will be departing due to the change in administration.

Overall, this CFSAC meeting continued the dismal record of forward movement regarding our disease.  Carol Head is committed to pushing for a number of process changes that may impact the underlying causes of dysfunction in the committee, and both she and SMCI are committed to making progress on ME/CFS both within and outside of CFSAC. To accomplish these goals, our organization will get in touch with each of CFSAC’s ex-officio members (government agency staff) individually to follow up on issues raised both in the meeting and by Carol Head’s presentation.

SMCI is pleased to provide the following CFSAC meeting summary for those who had difficulty watching remotely and were unable to participate.

Working Group Reports and Public Comments

  • The Stakeholder Engagement Working Group, including SMCI Advocacy and Engagement Manager Emily Taylor, reported that most agencies are failing to include and work with ME/CFS stakeholders effectively. The working group reviewed several models from other agencies and disease areas for effective engagement and made recommendations to the committee for improvement. The recommendations were not adopted; instead, they are to be rewritten and reconsidered at the next CFSAC meeting, where the working group will present additional recommendations. SMCI is disappointed that the hard work and strong recommendations of this working group were met with such resistance and failed to produce strong action.
  • The Pediatric Education Working Group gave reports on recommendations and the structure of school-based programs and medical professionals. While these reports and recommendations were very educational, it still highlighted the desperate need for education and empowerment.
  • A new working group on medical education was formed.
  • CFSAC heard public comments from many passionate patients and family members. For examples, please see comments from ME/CFS advocates Jennie Spotila and Terri Wilder.
  • Many working groups discussed several possible recommendations (in addition to revisiting previously submitted recommendations that were not adequately addressed) but did not formally adopt new recommendations. The only formal recommendations adopted were proposed from the Pediatric Education Working Group. The committee decided to continue the work of the Stakeholder Engagement Working Group and create a new Medical Education Working Group.

Agency Updates

  • The Centers for Disease Control and Prevention (CDC) published a new video regarding ME/CFS, attended several conferences regarding ME/CFS, held meetings regarding the CDC website revision to incorporate recommendations from the 2015 Institute of Medicine report, held an informational session for CDC staff with Dr. Jarred Younger, and answered questions about medical education efforts. Clearly, there is no immediate commitment to removing the now discredited graded exercise therapy (GET) recommendation from the CDC’s website, and many questions regarding the content of ME/CFS videos and stakeholder engagement processes remain unaddressed.
  • The Food and Drug Administration (FDA) answered questions regarding expediting drug approval, finding research commonalities, improving collaboration with other agencies, and improving scientific understanding of ME/CFS. Overall, the FDA expressed a commitment to interagency collaboration as well as a desire to improve stakeholder engagement. The FDA has demonstrated a strong understanding of the complexities associated with ME/CFS, earning praise from CFSAC member Dr. Jose Montoya.
  • The Social Security Administration (SSA) announced plans to focus on questions regarding clinical care and reversing stigma in the medical community. The SSA has also created a new, in-house continuing medical education program for providers and plans to add ME/CFS to the curriculum. The program is currently available to 3,000 physicians, and the agency plans to have the program available to every medical provider in their network by the end of fiscal year 2017. The ME/CFS component of the program remains under development, and SSA representatives committed to providing additional information regarding stakeholder involvement. SMCI pressed for CFSAC review of the program before release and pressed the SSA to make ME/CFS data more transparent.
  • The National Institutes of Health (NIH) addressed questions regarding clinical care, funding increases, the lack of an ME/CFS research case definition, research protocol releases, and disease stigma. The NIH also provided updates on the current intermural research study, progress and currently stated goals, RFAs, and the Trans-NIH ME/CFS Working Group. The specific funding for the two announced RFAs was released, including the total minimum funding figure of $29.7 million over five years. While not yet final, this figure is extremely disappointing; it does not begin to address the significant disparity in spending between ME/CFS and other diseases.
  • The Health Resources & Services Administration (HRSA) gave no formal presentation but answered questions regarding specific educational materials being generated for ME/CFS, stakeholder engagement, and its internal review process for materials produced by grantees. There was discussion of a flier that was produced under the auspices of HRSA that continues to treat ME/CFS inappropriately as a “lightweight” problem.
  • The Agency for Healthcare Research and Quality (AHRQ) presented an update on relevant projects that could overlap for ME/CFS, but AHRQ is limited from working on specific diseases. The ex-officio for AHRQ praised the ME/CFS community for its effective and data-driven advocacy, answered questions regarding the recent addendum that downgraded CBT and GET treatment recommendations, and discussed potential collaboration on medical education in the form of a physician’s guide. AHRQ expressed an eager willingness to assist SMCI and CFSAC with additional medical education tools but cannot do so without funding and direction from HHS.

Community Liaison Reports

  • SMCI President Carol Head delivered a hard-hitting call to action during her presentation to CFSAC, providing specific recommendations to each agency for improvements in the handling of ME/CFS. Carol was the first at the meeting to call ME/CFS a “public health crisis” before adding that the committee “has been almost utterly ineffective in addressing it.” The key goal of Carol’s presentation was to share solid, actionable steps to move forward and make progress by breaking down bureaucratic red tape, taking a strong leadership position, and bringing ME/CFS stakeholders into the process of government rather than forcing them to remain on the sidelines. Carol spoke thoughtfully and with force on behalf of those suffering with ME/CFS across the country. To watch Carol’s presentation, go here. To look at Carol’s slide deck, go here.
  • The International Association for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis meeting summary included key scientific and treatment study results as well as an analysis of the field.

Meeting with an ME/CFS Champion in our Congress

January 20, 2017

Lofgren GroupPrior to last week’s federal CFSAC meeting, SMCI’s advocacy team visited with Congresswoman Zoe Lofgren of California who, together with colleague Congresswoman Anna Eshoo of California, sponsored the powerful congressional ME/CFS letter to National Institutes of Health (NIH) Director Collins in September 2016. Congresswoman Lofgren met with SMCI President Carol Head, SMCI Board Members Mary Dimmock and Diane Bean, and Diane’s daughter Lauren Bean, who suffers from ME/CFS. They discussed next steps for making progress in Congress for ME/CFS in 2017, including the potential formation of an ME/CFS caucus and a week-long Capitol Hill advocacy effort corresponding with International ME/CFS Awareness Day on May 12. SMCI and Congresswoman Lofgren are committed to working together strategically with advocates and organizations nationwide. Stay tuned for more updates from our SMCI advocacy team!

Listen to Carol Head’s Rousing CFSAC Presentation

January 20, 2017

O Mag carol head circleSMCI President Carol Head delivered a hard-hitting call to action during her presentation to CFSAC, providing specific recommendations to each agency for improvements in the handling of ME/CFS. Carol was the first at the meeting to call ME/CFS a “public health crisis” before adding that the committee “has been almost utterly ineffective in addressing it.”

The key goal of Carol’s presentation was to share solid, actionable steps to move forward and make progress by breaking down bureaucratic red tape, taking a strong leadership position, and bringing ME/CFS stakeholders into the process of government rather than forcing them to remain on the sidelines. Carol spoke thoughtfully and with force on behalf of those suffering with ME/CFS across the country.

To watch Carol’s presentation, go here.

To look at Carol’s slide deck, go here.

Non-Invasive Diagnostic Test Project Seeks to Detect ME/CFS

January 13, 2017

maughan gleesonThis week, we highlight the Cathleen J. Gleeson PhD Fund and our collaborative partnership with the University of Washington on diagnostic testing in ME/CFS.

This study of diagnostics and metabolic imaging uses advanced, non-invasive magnetic resonance spectroscopy (MRS) to measure muscle metabolites in ME/CFS patients before and after fatiguing exercise.

Pilot testing conducted earlier through this project compared a single patient with ME/CFS to that of a matched healthy control. Preliminary analysis revealed abnormal levels of certain metabolites, most notably NAD (P) H, in the ME/CFS subject compared to the healthy control. This result points to cellular metabolic dysfunction in a specific pathway that may itself promote and suffer from oxidative stress. The difference in metabolic profile was most pronounced the day following fatiguing exercise, mirroring a commonly reported timeline of symptoms for those with ME/CFS.

This preliminary data suggests that an abnormal response of NADP and its cofactor, NAD(P)H, may be a molecular marker for ME/CFS-related oxidative stress at the cellular level.

The proposed experiments are designed to test whether this abnormality is also observed in a larger set of subjects diagnosed with ME/CFS. Confirmation of the result would establish MRS as a powerful tool to non-invasively detect and measure a molecular signature of this disease. If successful, our research would establish a new, breakthrough research platform for understanding the molecular basis of ME/CFS.

This study is made possible by a grant from the Cathleen J. Gleeson PhD Fund and is led by Kevin Conley, PhD, professor of radiology and co-director of the Translational Center for Metabolic Imaging at the University of Washington and David Maughan, PhD, a professor emeritus of molecular physiology & biophysics at the University of Vermont and visiting scholar in radiology at the University of Washington.

New Study Explores Role of Energy-Regulating Enzyme PDH in ME/CFS

January 13, 2017

PDHA new study entitled “Metabolic profiling indicates impaired pyruvate dehydrogenase function in myalgic encephalopathy/chronic fatigue syndrome” by Fluge et al. was recently published in the leading Journal of Clinical Investigation.

The study examined a total of 300 participants (approximately 200 ME/CFS patients, diagnosed according to the Canadian Consensus Criteria, alongside 100 healthy controls). Using blood samples, analysis of participants’ metabolism was performed, leading to the identification of specific biochemical changes in ME/CFS patients versus their controls.

Specifically, blood samples showed that levels of certain amino acids (the building blocks of proteins) were reduced compared to those of healthy control subjects. From these patterns, the authors looked at the pyruvate dehydrogenase (PDH) enzyme, a key regulator of energy metabolism and lactate production as well as a potential contributor to the above-mentioned pattern detected. Consistently, gene expression analyses (which typically determine the levels and content of a gene product and therefore its biological activity) reveal significant differences that implicated reduced function of this energy-regulating enzyme. Of note, no difference in gene expression was present between female and male ME/CFS patients.

Dr. Nahle, SMCI’s chief scientific officer and vice president for research, stated that this study “is very significant because it points to a potential alteration in a key enzyme in the energy producing machine inside the cells.” Added Dr. Nahle, “in the interest of full disclosure, we submitted a proposal to the NIH in early 2016 in collaboration with Drs. Sheila Stewart of Washington University in St. Louis and Susan Levine of The Levine Clinic in Manhattan to study this specific enzyme complex, the pyruvate dehydrogenase complex, in ME/CFS. Regrettably, our proposal was not funded. We believe Fluge et al. is absolutely on the right track, and this line of work is music to our ears. The projects we are supporting and investing in are heavy on bioenergetics, lipidomics, and metabolomics as very promising areas in ME/CFS biology.”

A more thorough analysis of the Fluge et al. paper will be done by Dr. Nahle at a later date, analyzing these results in the context of his previously published work on the role and function of PDH in diabetes and cancer and its relevance to ME/CFS.

January 2017 Research 1st – Dr. Nahle Letter

January 13, 2017

zaher

Dear Friends,

With every new year, we renew our commitment to remain the uncompromising force working on behalf of patients. Indeed, our dedication to finding solutions to this disease has never been stronger or better focused. And while we scrape a dollar from here and a penny from there to survive as a non-profit research organization, we are unashamedly proud to see our investments in research doubling if not tripling across the disease spectrum as a result of this frugality.

Last January, we committed to the following:

  • Creating environments in which real and durable research and advocacy collaborations develop and flourish, reframing a narrative through which all voices in ME/CFS can be heard and respected. Through unity and cross-pollination, we felt we could effectively deconstruct stubborn medical challenges.
    • True to our promise, we acted as an agent for change and unity at every opportunity. We met with government officials and science leaders, advocated for policies and federal actions, and authored dozens of opinion and technical pieces addressing current ME/CFS affairs across the science, research, and policy landscapes. We assertively participated in conferences and convened some of the top minds in ME/CFS clinical care and research to collaborate on the key issues facing ME/CFS through our Research Advisory Council and other think tanks.
  • Supporting quality work that is original and bold, building on the momentum of 2015 and the positive indicators it brought.
    • Our support of innovative research projects in bioenergetics, autoimmunity, genetics, and neuroendocrine functions now extends from the US to the UK, Germany, and Australia. This commitment to quality research brings new talent to the field and strengthens the existing human capital in the disease.
  • Investing aggressively in research initiatives that would emphasize the role of patients as partners—not subjects—and enable the creation of measurable and tractable impact toward understanding the pathophysiology of ME/CFS.
    • With targeted investment in severe knowledge gaps—such as pathway and biomarker discovery, immuno-senescence and cell-cycle energetics, drug screening and functional genomics, diagnostics and advanced imaging, and metabolomics and big data research—we are creating value across every phase of the discovery process. These are the elements of our growing portfolio of investment in ME/CFS at some of the most prestigious medical centers and research establishments in the country, including Washington University in St. Louis, the University of Washington, Memorial Sloan Kettering Cancer Center, Cornell University, and Metabolon.

Exactly a year ago, I borrowed the words of President Lincoln in a time of political uncertainly: “The dogmas of the quiet past are inadequate to the stormy present. The occasion is piled high with difficulty, and we must rise with the occasion.” This has never been more applicable to the here and now. That is precisely why we are trying to shift the paradigm and alter the status quo.

You have our steadfast commitment to double our efforts in 2017, building on our activities of this past year. I wish you all the gift of health.

Yours,

Zaher Nahle
Chief Scientific Officer
Vice President for Research
Solve ME/CFS Initiative

 

Dr. Maureen Hanson Visits SMCI to Discuss Ongoing Collaboration

January 13, 2017

Ohansonn Thursday, January 5, Dr. Maureen Hanson of Cornell University visited SMCI’s Los Angeles headquarters. Dr. Hanson’s visit provided the opportunity to meet with SMCI President Carol Head and Chief Scientific Officer and Vice President for Research Dr. Zaher Nahle to discuss ongoing projects and collaborations on a number of studies.

As you may know, Dr. Hanson, together with Dr. Sue Levine of The Levine Clinic in New York and metabolomics leader Metabolon, is a partner in one of our four SMCI-Directed Research Studies. The initial testing phase of this pathway and biomarker discovery study has been completed. The study will now analyze the metabolome of the 100 well-characterized early- and late-stage ME/CFS patients and healthy controls tested, examining microbiomes using mass spectrometer multiplex platforms.

This study is part of SMCI’s effort to invest in and initiate projects addressing the knowledge gap in the field of ME/CFS to identify functional culprits in the pathophysiology of the disease using advanced technologies.

SMCI-Directed Research Study Explores Immuno-senescence

January 13, 2017

stewartAnother of our SMCI-Directed Research Studies is being conducted in partnership with Dr. Sheila Stewart of Washington University in St. Louis in collaboration with Dr. Masashi Narita of the Narita Group at Cambridge University in England. This study explores immuno-senescence and cell-cycle analysis in the pathophysiology (or functional changes that accompany a particular syndrome or disease) of ME/CFS.

As described by Dr. Stewart, recent work has shown patients with ME/CFS to have alterations in immune cells as well as in the p38 Map Kinase (p38MPAK), a key pathway critical for proper cell function.

Whether these observations are related to the symptoms associated with, is the cause of, or simply has a correlation to ME/CFS remains to be understood.

Immuno-senescence refers to the interplay between aspects of immunity, either localized or systemic, and those of senescence cells. In other words, it refers to cells that have stopped duplicating or dividing prematurely.

Factors known to trigger premature senescence include

  • Oxidative stress (stress caused by improper metabolic processing)
  • Telomere dysfunction (telomeres act as a type of endcap for DNA, and their dysfunction contributes to several complex diseases like cancer)
  • DNA mutations/damage (which can be caused by irradiation and many other factors)
  • Oncogenic pressure (improper functioning of cancer-causing genes)

Intriguingly, p38MAPK activation is an important component in the alteration of a tissue’s extracellular matrix (ECM), the function of local immune cells, and the growth and spread of tumor cells. Given the role senescence cells play in these different disease settings, it is possible that their activation contributes to symptoms in ME/CFS patients.

Results from this study have the potential to be quite significant and may include

  • Expanding the role of cellular senescence in ME/CFS and providing additional context and clarity
  • Identifying specific biological signatures from well-characterized patients
  • Developing mechanistic insight into comorbidities associated with ME/CFS
  • Uncovering potential new biomarkers that could help with rapid and effective diagnosis
  • Comprehending signaling pathway interactions involved in the disease
  • Supporting existing projects and hypotheses by our research organization and others as well as generating new hypotheses
  • Classifying patients based on molecular alterations
  • Developing precision medicine profiles, categories, and subcategories in ME/CFS with additional patients

We expect that the initial phase of this new project will be completed in 2017, with results requiring additional mechanistic investigation to establish findings as reproducible and validated targets.

Dr. Zaher Nahle, SMCI’s chief scientific officer and vice president for research, stated, “This is an important investigation addressing an area of biology in ME/CFS that is still ill defined. And we could not be more excited about our partnership with Drs. Stewart and Narita, who are leading pioneers in this field. It is our hope that this study will reveal signatures and identifiers pointing toward biomarkers and also the molecular basis for the disease and its subgroups. The results from this study will help us to hone or validate our hypotheses. And, what’s more, we will be able to seek new partnerships and assist the work of others by publishing these results alongside our collaborators.”

Ramsay Research Team 5 – The Potential Role of HHV-6 in ME/CFS

December 16, 2016

team-5This study from Dr. Bhupesh Prusty (Julius Maximilian University of Wurzburg) is entitled “HHV-6 Mediated Mitochondrial Modulation and Its Association to ME/CFS.”

While the precise role of pathogens in the development of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) remains mostly uncharacterized, human herpesvirus 6 (HHV-6) is frequently associated with the disease (as well as several other diseases).

Originally, the integration of HHV-6 into human chromosomes in order to achieve latency was thought to be the dead end for the virus. However, recent publications demonstrate that certain timely triggers like circumstances of immune suppression or the influence of various drugs and/or pathogenic infections can activate this virus.

This study’s preliminary work shows that HHV-6 targets the cell’s energy reserve, the mitochondria, during

both active infection and activation from latency leading to mitochondrial dysfunction—a condition also frequently associated with ME/CFS.

This new study aims to identify the contributing factor from HHV-6 that is directly responsible for the signaling processes leading to host cell mitochondrial changes and link HHV-6 and mitochondrial changes using ME/CFS patient materials. This would further understanding of the root causes of ME/CFS. Molecular mechanisms behind direct association between HHV-6 and human mitochondria have never been studied before.

The anticipated outcome of this pioneering research idea is clarification of a novel, infection-induced mechanism for the onset and/or progression of ME/CFS that will open new targets for drug development.

Noted Dr. Prusty, “Without prior spotlight in the ME/CFS research community, it is extremely difficult to acquire funding to continue our work. Funding from Solve ME/CFS Initiative, which recognizes and promotes young investigators and novel innovative research ideas, came just at the right time, and we greatly appreciate this award.”

Read this study’s abstract here: http://solvecfs.org/hhv-6-mediated-mitochondrial-modulation-and-its-possible-association-to-mecfs/