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.

 

Introducing the Common Data Elements Working Group

February 10, 2017

The National Institutes of Health (NIH), in partnership with the Centers for Disease Control and Prevention (CDC), has recently launched the Common Data Element (CDE) Working Group with the intent to streamline medical and research terminology in ME/CFS. The ultimate goal of this ambitious project is to standardize the collection, analysis, and comparison of data across multiple research studies. CDEs are becoming a foundational requisite in biomedical research in any field, and this is especially true for a disease where confusion regarding case definition, inclusion criteria, and study design continue to exist.

According to program officials, the goals of the working group are to

  • Develop common definitions and standardize case report forms (CRF) and other instruments
  • Help investigators conduct clinical research through the development of uniform formats by which clinical data can be systematically collected, analyzed, and shared across the research community

The working group includes government officials with expertise in ME/CFS and volunteer clinicians, scientists, advocates, and caregivers—many of whom are well-known figures in the ME/CFS community.

Dr. Zaher Nahle, SMCI’s chief scientific officer and vice president for research, is a member of this working group. Said Dr. Nahle, “This is an important and ambitious project. The participation of dozens of disease and community experts as volunteers underscores its importance and anticipated value. Given this unique and rare opportunity, it is our belief that a definitive case definition should be adopted as part of these discussions; it is ostensibly the most confounding issue in any research investigation involving human subjects, especially ME/CFS.”

The CDE Working Group has been divided into eleven specialized subgroups/panels with a total of 74 seats, with some experts participating in more than one subgroup. The eleven subgroups that have been formed are as follows:

  • Fatigue
  • Sleep
  • Quality of Life/Functional Status (CPET Testing)/Activity
  • Immune
  • Pain
  • Baseline/Covariate Information
  • Post-Exertional Malaise (PEM)
  • Autonomic
  • Neurologic/Cognitive/CNS Imaging
  • Neuroendocrine
  • Biomarkers (EEG, cytokines, NK cell function)

This project will take place over several months, and we will update the community periodically on its progress.

Power to the Patients! Announcing SMCI’s New ME/CFS Advocacy Webinar Series

February 10, 2017

Be An AdvocateWant to be an advocate, but you’re unsure how to begin? Introducing our new advocacy webinar series, Power to the Patients! Led by Advocacy and Engagement Manager Emily Taylor, this webinar series open to all will give advocates the tools needed to flex their citizen power just in time for congressional budget season.

Whether you’re a newcomer or a seasoned advocate, join us on Thursday, March 2, at 10:00 AM PT/1:00 PM ET to learn 6 Ways to Maximize Your Congressional Advocacy Impact. We’ll also provide an overview of SMCI’s congressional advocacy plans for 2017 and how you can help. The goal of this series is to empower existing ME/CFS advocates and activate fresh allies in our fight. Your voice can make a difference. Join the fight to solve ME/CFS by registering for this free, one-hour webinar here.

February 2017 Research 1st – Dr. Nahle Letter

February 10, 2017

Dear Friends,
zaherOn January 27, the National Institutes of Health (NIH) posted two competitive funding opportunities: one for collaborative research centers (CRCs, U54) and another for a data management and coordinating center (DMCC, U24). This was followed by a call with the ME/CFS community in which Dr. Koroshetz, the director of the National Institute of Neurological Disorders and Stroke (NINDS), described the intent, magnitude, and scope of these new funding opportunities alongside key officials at the Trans-NIH Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) Working Group.
For years now, the ME/CFS community has been vocal about the need for a tangible commitment from the NIH, and such news is certainly welcomed. Seemingly, this new development is a step in a sequence of events that started with the intent to bolster ME/CFS as announced by National Institutes of Health (NIH) Director Dr. Francis Collins in late 2015. This was followed by the establishment of the NIH intramural study on ME/CFS earlier last year, the roll out of supplemental awards for existing grants on the subject, the solicitation of the Request for Information (RFI) to generate input from the scientific community, and the commencement of the Common Data Element (CDE) project in partnership with the Centers for Disease Control and Prevention (CDC). We reported on each step periodically and continue to welcome any step toward advancing the science on ME/CFS.

Here, we make two points directly related to these new funding opportunities:

Zaher Feb Letter Graphic• In addition to these new center programs, creating dedicated requests for applications (RFAs) for stand-alone, investigator-initiated proposals (e.g., RO1 and R21 mechanisms) in ME/CFS will establish viable career paths for investigators and signal long-term commitment to this disease. These mechanisms have been the backbone of fueling discovery through NIH funding, and ME/CFS must be no different. Of note, many investigators or individual laboratories may have neither the bandwidth nor the connections to put together—or even participate in—prospective center grants, especially since these centers can be highly politicized (we believe this politicization must be avoided at all costs).

• Reviewing applications for these centers is critical. Particular attention must be placed on the nature and composition of the review panel. Having reviewers unfamiliar with or uninterested in ME/CFS could undermine this commendable effort. Standards must be upheld at all times to select the most meritorious grants.

As we always say, all elements of goodwill at the NIH, and in the community, must be harnessed constructively moving forward. These new center grants are just one element in a large toolkit of instruments at the NIH that includes exploratory grants, investigator-initiated awards, and a multitude of clinical and research training grants. All of these must be activated with the same commitment, to address different segments in capacity building, creating infrastructure and know how. If the NIH continues to expand its commitment, taken together, these elements constitute a framework for a comprehensive strategy to promote the understanding of a complex disease like ME/CFS.

Best,
Zaher

 

Carol Head Participates in Meeting at UCLA Clinical and Transitional Science Institute

January 26, 2017

UCLA CTSI photoThe goal of clinical and translational science institutes (CTSIs) is to combine disciplines, resources, expertise, and techniques to promote enhancements in prevention, diagnosis, and therapies. There are now CTSI’s at most leading research universities. The UCLA CTSI is a dynamic partnership of four institutions in the Southern California area.

Located just six miles from Solve ME/CFS Initiative’s office in Los Angeles, UCLA is a natural fit for making valuable research connections. Both Carol and SMCI Chief Scientific Offer and Vice President for Research Dr. Zaher Nahle are seizing this opportunity to strengthen relationships with key researchers at UCLA.

SMCI President Carol Head was invited to sit on the UCLA CTSI Patient Advocacy Board, which meets quarterly. She was selected based on her role as a health advocate and her status as a patient with a chronic disease. Said Carol, “Clearly UCLA is a leader in medical research, and I’m honored to provide patient perspectives.”

As an Advisory Board member, Carol offers her perspectives on how to ensure the impact of CTSI’s scientific work to improve health reaches patients and family members. Additionally, she and other board members provide feedback on CTSI’s efforts to improve the engagement of patients and family members who may participate in future research topics, such as study design, study informed consent processes, study recruitment approaches, data analysis and data safety monitoring, data privacy and security, and ethics.

Jen Brea’s ME/CFS TED Talk Gets over 365,000 Views in First Week; Documentary Film Unrest Premieres at Sundance Film Festival

January 26, 2017

jen brea ted talk 2Jen Brea’s much-anticipated TED Talk, “What happens when you have a disease doctors can’t diagnose,” discussing the stigmatization of hard-to-understand diseases went live on January 17. Since its release, it has received over 394,000 views, giving ME/CFS excellent exposure to the public at large and likely introducing it to many individuals who had not previously heard of the disease. If you haven’t yet watched Jen’s TED Talk, be sure to watch it here.

Also this month, Jen Brea’s documentary film, Unrest, premiered in the documentary competition at the Sundance Film Festival. Head of the Salt Lake City-based Bateman Horne Clinic and SMCI Research Advisory Council member Dr. Cindy Bateman arranged a private film screening for those whose lives have been touched by ME/CFS. Unrest won’t be made available to the public until it goes through the circuit of film festivals and finds a distributor, but we are rooting for this film to obtain broad distribution so that many more people will come to understand the devastation of this disease.

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 in Washington DC for one of its biannual meetings. 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, despite the efforts of individuals serving on CFSAC. 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 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 educational, it still highlighted the desperate need for education and empowerment for young people with this disease. The recommendation was passed unanimously and will go to the incoming, and not yet known, secretary of HHS.
  • 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.

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 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 NIH has said that it intends to release the two RFAs before the end of January.
  • 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. SMCI calls for clear accountability, oversight, and stakeholder engagement requirements for HRSA grantees when producing materials relating to ME/CFS.
  • 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, 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 positive, 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.