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.

 

New Documentary Film by ME/CFS Advocate Jennifer Brea Set to Premiere at Sundance

December 2, 2016

unrestThe debut of the highly anticipated documentary from ME/CFS advocate Jennifer Brea was announced earlier this week. The film, once known by the name Canary in a Coal Mine and now titled Unrest, will premiere in January at Sundance, one of the world’s most prestigious international film festivals.

Unrest follows the personal stories of several ME/CFS patients, including Jennifer and her husband Omar, and was partially funded by over 2,500 backers on Kickstarter several years ago.

The competition for new films to premiere at the Sundance Film Festival is extremely high. SMCI extends huge congratulations to Director Jennifer Brea for this achievement. We all hope that this documentary will obtain broad distribution so that many people will come to understand how devastating this disease can be. SMCI is delighted to work with Jennifer Brea and her team to promote the film.

Solve ME/CFS Initiative Joins Letter on CBT and GET

December 2, 2016

cdcA letter jointly signed by the Solve ME/CFS Initiative (SMCI) and over 50 other ME/CFS organizations and advocates was sent to the Centers for Disease Control and Prevention (CDC) this week. The letter, authored by leading advocate and SMCI board member Mary Dimmock, calls for action on the cognitive behavioral therapy (CBT) and graded exercise therapy (GET) recommendations that continue to reside on the CDC’s website despite years of community protests. The letter eloquently summarizes the numerous updates in the field, including the recently published Agency for Healthcare Research and Quality (AHRQ) addendum regarding the PACE trial, and again calls upon the CDC to act.

The letter highlights the damage CBT and GET can cause through the story of Nita Thatcher, an ME/CFS patient featured in David Tuller’s most recent report, “Worse Than the Disease,” and cites four key issues with the PACE trial, which purported to find benefit to patients from CBT and GET: 1) Poor conduct, 2) the inaccurate disease definition utilized, 3) the scientifically invalid disease theory, and 4) the harm done to patients by CBT and GET.

The CDC’s website is considered the definitive source for medical information for many, including both doctors and patients. The ME/CFS community, including our organization, has long called upon the CDC to remove incorrect information. Time will tell if, with this compelling letter, at long last the CDC will act.

Go here to read the letter sent to the CDC and its accompanying documents.

Community Announcement on the October 24 DeSalvo Meeting

December 2, 2016

desalvoAs reported in the August 5 update on the meeting between HHS and advocates for ME on August 1, Assistant Secretary of Health Dr. Karen DeSalvo had committed to follow up on specific actions and meet again in October. On October 24, Jen Brea, Terri Wilder, Carol Head, Jennie Spotila, and Mary Dimmock met again with Dr. DeSalvo and other HHS staff members to follow up on those actions and to reiterate the concerns that HHS’s actions to date, while encouraging in places, have lacked the urgency and magnitude of action required to address the challenges of this community in a time scale that matters to patients.

Also participating in the meeting from Health and Human Services were Dr. Karen Scott, Chief Medical Officer of the Office of the Assistant Secretary of Health; Dr. Nicole Greene, Deputy Director of the Office of Women’s Health; Gustavo Seinos, Designated Federal Official for the CFS Advisory committee (CFSAC); and Ben Panico, Special Assistant to the Assistant Secretary of Health. As in the previous meeting, Dr. DeSalvo and her staff were fully engaged, asked insightful questions, and suggested additional ideas for moving forward, particularly with CFSAC and ensuring that we don’t lose progress with the transition.

In the August meeting, Dr. DeSalvo had committed to reach out to the Precision Medicine Initiative and also to her counterparts at the Veteran’s Administration (VA) and the Department of Defense (DOD) to identify additional opportunities to advance ME. She had also suggested that there might be opportunities to make the CFSAC more responsive to needs when the charter was updated in September.

When we met in October, Dr. DeSalvo told us that both the DOD and VA were interested, with the VA particularly interested in the overlap with Gulf War Illness (GWI), a theme that was emphasized in the October conference at the NeuroImmune Institute at Nova University. That conference highlighted overlaps between ME and GWI, and demonstrated how work being done in GWI is potentially useful for ME patients. Furthermore, the DOD could be another potential funding source for ME through its Congressionally Directed Medical Research Program (CDMRP), which includes research on GWI. ME was included in the CDMRP in 2011 and has also been included as a comparison group in some GWI studies.

As a result of her efforts, the CFSAC charter was updated to include representatives from the DOD and the VA, and to include ME three patients or patient carers. The CFSAC charter was also updated to specify that the Assistant Secretary of Health is now responsible to coordinate and monitor CFSAC recommendations adopted by HHS and that CFSAC’s duties include making recommendations on ways to ensure that community input is incorporated in HHS policy and research. These changes should ensure greater accountability for HHS to achieve the goals and outcomes that matter most to patients. It will be up to the ME community to ensure this happens.

Dr. DeSalvo acknowledged that Centers for Medicare and Medicare Services (CMS) was no longer an ex-officio in the updated charter. But she noted that CMS has agreed to participate as needed in CFSAC meetings. She also stated that future charter changes could be made to address gaps and increase CFSAC’s effectiveness.

Dr. DeSalvo also noted that she had also reached out to the Precision Medicine Institute but that at this time, the sense was that ME research would be better served by research efforts focused specifically on ME, given the relative lack of knowledge about the underlying pathology of the disease. We also discussed the upcoming change in the administration and the impact that this could have on progress to date. Dr. DeSalvo stated that ME has been included in the packet of information being prepared for the transition teams. We provided a supplementary two-page document summarizing the most urgent needs of people with ME, and we will continue follow up with the new administration.

Finally, while HHS had begun to make progress, particularly with NIH’s efforts to ramp up research, we again emphasized to Dr. DeSalvo that HHS’s efforts were still too small, too slow, too uncoordinated, and too internally focused. This has left research funding still woefully inadequate and there are no plans to address the crisis in clinical care, to follow up in parallel on promising clinical trials, or to conduct much-needed epidemiological research. We also reiterated our concerns that CFSAC would not be able to provide the level of planning, coordination, and community engagement required to move the field forward.

More recently, we alerted Dr. DeSalvo to the widespread concerns with ME denialist

Together, the two meetings with Dr. DeSalvo resulted in steps to move the field forward in helpful ways and to take steps to ensure that the community does not lose traction during the transition. But much more will need to be done to achieve the magnitude and speed of response required to alleviate the suffering of patients with ME. Please make your voice heard by finding ways to get our story into the media, by continuing to contact your congressional leaders to call for change, and by attending the upcoming CFSAC meeting in Washington, D.C. and on the web on January 12 and 13, 2017.

 

21st Century Cures Act Passes House with Overwhelming Bipartisan Support

December 2, 2016

energycommercelogo_orangeME/CFS advocates have been eagerly awaiting passage of the 21st Century Cures act since it was initially introduced in 2013, given it was originally written to increase NIH funding and fast-track research and treatment development. On Wednesday, November 30, a compromise bill with modified provisions from the original 21st Century Cures Act swept the House in a 392 – 26 vote. “We have listened to every group out there,” said Representative Fred Upton, author of the bill. “I think we have a pretty good bipartisan bill that’s going to meet everyone’s test of how legislation should be done.” Had the bill not been passed before the end of December, the process to craft it would have had to start again from scratch in the new year.

While the new $6.3 billion compromise funnels new funds to the NIH, those funds are targeted for specific programs such as The Precision Medicine Initiative, Cancer Moonshot, and the BRAIN Initiative and are unlikely to benefit ME/CFS research directly. Additionally, unlike the original bill, these funds are subject to yearly congressional review and can potentially be withheld or redirected.

The compromise package passed this week lost many key initiatives supported by our organization, such as the “OPEN” Act, incentives for misunderstood disease research, and flexible funding for the NIH. Additional elements, such as funds to combat opioid addiction, provisions addressing Medicare, and mental healthcare streamlining, were added in the compromise.

A few key elements that remain in the current legislation which could positively impact ME/CFS include

  • Increased accountability at the NIH

In a new process that is welcome news to many ME/CFS advocates, the 21st Century Cures Act provides increased oversight, accountability, and transparency at the NIH. The new law requires the NIH to issue and publish a strategic plan and increases accountability at the NIH overall, including the system used in the distribution of grant awards. SMCI has continually pressed the NIH for this information regarding ME/CFS with virtually no success.

  • Removing barriers to increased research collaboration

Provisions directed at data standardization, data collection and sharing, and clinical trial reporting are designed to increase collaboration between researchers for better results. There are also provisions to modernize clinical trials and increase the use of patient-generated registries, both of which have been key barriers in ME/CFS research.

  • Incorporating the patient perspective

One of the most controversial parts of the bill increases the ability for researchers and the Food and Drug Administration (FDA to consider the direct experience of patients to modify and improve potential treatments. This new, structured framework would take patient reports into account when analyzing a drug’s benefits and risks.

  • Improved biomarker qualification

One additional provision added to the 21st Century Cures Act is called the “Drug Development Tools Qualification Program.” This section will create a new review process at the FDA for biomarkers and other development tools to expedite drug development and reduce the likelihood of development failures.

Go here to read the SMCI’s previous coverage of the 21st Century Cures Act.

November 29, 2016

SMCI’s 2016 Accomplishments in Research

  • Launched three Targeted Initiatives, our own focused projects done in partnership with leading research institutions and biomedical corporations, that represent a paradigm-busting approach to conducting research:
    • Pathways and Biomarkers Discovery Track. Original research in the areas of bioenergetics, metabolomics, and lipidomics using high-throughput technology in partnership with Metabalon. Testing completed. Includes analysis of the gut microbiome.
    • Immunosenescence and cell-cycle analysis in the pathophysiology of ME/ CFS. Partners in this targeted initiative include Dr. Masashi Narita of the Narita Group at Cambridge University and Dr. Sheila Stewart of Washington University in St. Louis.
    • Drug screening and functional genomics studies. These aim to uncover potential drug screening targets in ME/CFS. Partners in this targeted initiative include leading experts at Memorial Sloan Kettering Cancer Center—namely, Drs. Ralf Garippa, Scott Lowe, and Myles Fennell.
  • Provided seed grants through the Ramsay Award Program for pilot studies in ME/CFS research. The program generated applications from the US, the UK, Germany, and Australia. The review has been completed, and awards will be announced in early December.
    • The awards will support studies in gut microbiome, autoimmunity, bioenergetics, pathogenic interaction, inflammation, brain imaging, and metabolomics. This year we are offering more grants than ever before AND with greater frequency than ever before. Ramsay Awards are an annual grant program.
    • Peer-review selection criteria included significance, quality, feasibility, innovation, novelty, and research environment, among other things. Specific projects include characterizing autoimmunity signatures, studying viral interaction with   mitochondrial function, using advanced brain thermoimaging to define altered brain biology and low-grade inflammation, defining bioenergetics health index and mitochondrial myopathies in natural killer and immune cells, and studying B-cell metabolic and cellular alteration in the context of Rituximab.
  • Launched a new, improved ME/CFS patient registry in collaboration with the Robert Wood Johnson Foundation and Genetic Alliance. This is a new, large scale-project that will enable organizations to coordinate and improve clinical trials and study design. Platform completed. Beginning to populate with patient data in Q1 2017. Working closely with the NIH on data collected.
  • Upgraded and vitalized a webinar series to get thought leaders and influencers to update the community. These webinars included speakers from the CDC and the NIH as well as ME/CFS expert like Drs. A. Komaroff, S. Levine, J. Younger, M. Hanson, and others. We are expanding this into medical education.
  • Convened a think tank of experts, in the presence of the NIH representative, to create permissive space for collaboration on pressing issues. Included Dr. Komaroff, Dr. Kogelnik, Dr. Lowe, Dr. Bateman, and others. A “who’s who” of ME/CFS experts.
  • Launched the meetME Travel Award program (in coordination with the NIH) to facilitate the participation of young talent and underrepresented groups to attend ME/CFS specialized meetings and conferences.
  • Asserted presence at key ME/CFS conferences in the US and UK, including presentations and presence at the following meetings:
    • Invest in ME conference and colloquium (June 2016)
    • Action for ME/CMRC conference big data session (September 2016)
    • IACFS meeting (October 2016)
  • Competed for extramural grants. Submitted two grants to the NIH to seek funding for ME/CFS and support a specialty conference on ME/CFS.

 

SMCI’s 2016 Accomplishments in Advocacy

  • President Carol Head met with the Asst. Secretary of Health and Human Services (HHS) to discuss the egregious lack of federal funding for this disease. At last, we are talking with federal staff senior enough to make a difference: a second meeting is scheduled for October.
  • Restored funding for the CDC ME/CFS study after it was zeroed out in the FY 17 budget. Intense lobbying effort and Capitol Hill visits resulted in the funding being restored with additional supportive language in the Senate committee report.
  • Authored a letter, in partnership with other advocates and Congresswomen Zoe Lofgren and Anna Eshoo, to NIH Director Francis Collins that was cosigned by 55 members of Congress and called for additional ME/CFS research funding.
  • Served (and continue to serve) on the federal Chronic Fatigue Syndrome Advisory Committee (CFSAC) and contributed as a member of the Stakeholder Engagement subcommittee.
  • Advocated through professional committees at the NIH and CDC (e.g., the CDC Technical Development Workgroup) to develop educational materials.
  • Formed increasingly strong and close relationships with key figures at the NIH and CDC.
  • Joined Research!America advocacy alliance for medical research and supported the 21st Century Cures Act, appropriations finalization, and other actions in support of medical research investment.
  • Supported Federal Disability Integration Act for revised programs and regulations that support ME/CFS patients.
  • Supported and spoke at the two #MillionsMissing days of actions (there were 25 worldwide) to bring attention to the disease.

Advocacy in Action: SMCI Joins the Research!America Alliance

November 18, 2016

researchamericaThe Solve ME/CFS Initiative is proud to announce our formal membership as part of Research!America, an alliance for discoveries in health. Research!America is the nation’s largest and most effective advocacy coalition dedicated to making medical research for health and scientific research funding a higher national priority. The Solve ME/CFS Initiative is the first organization to join the alliance that is exclusively dedicated to ME/CFS.

SMCI was initially contacted by Research!America to provide technical assistance regarding ME/CFS for the “Investment in research saves lives and money” fact sheet campaign. As a formal member, SMCI is proud to lend its support to the fight for research funding and share Research!America’s insider political analysis on the policy landscape in health and research with our patients and supporters. Side by side with over 360 members from the lab bench to the bedside, SMCI is proud to have taken several major actions with the Research!America alliance:

SMCI supports the 21st Century Cures Act: This pending legislation has significant importance for ME/CFS, including funding for research, increased accountability at the NIH, the removal of barriers for researcher collaboration, added value to the patient perspective, and new incentives to research misunderstood diseases. We wholeheartedly support this bill and invite you join us in support by going here.

Called for the finalization of the fiscal year 2017 (FY17) spending bills: There is a strong possibility that Congress will pass a short-term continuing resolution that flat funds most government agencies and programs through 2017 instead of finalizing a budget normally before year-end. A continuing resolution would delay and potentially rule out a pending $1.25-$2 billion budget increase for the National Institutes of Health (NIH) as well as budget increases for other crucial health agencies. SMCI joined a sign-on letter and contacted members of Congress to urge them to complete their work on FY17 spending bills this year in order to ensure that this funding increase REALLY happens.

SMCI joined #CampaignforCures: Campaign for Cures, a national voter education initiative led by Research!America and partner organizations, elevated the importance of research and innovation this election season. Through strategic grassroots activities, communications initiatives, and partnerships with preeminent voter education groups, we are raising awareness about the importance of sustaining medical progress.

Partnering for Cures Conference on the Forefront of Moving Disease Solutions Forward

November 18, 2016

fastercuresPresident Carol Head and Vice President for Research and Scientific Programs Dr. Zaher Nahle attended the annual Partnering for Cures event organized by FasterCures, based in Washington DC. FasterCures is an action tank of the Milken Institute that works to speed up and improve the medical research system.

This conference is a unique opportunity to build partnerships with numerous stakeholders across academia, industry, and the federal government. In addition, it offers a platform with dedicated sessions to learn from what other disease organizations have done regarding biomedical innovation, effective advocacy, and partnering with federal agencies such as the National Institutes of Health (NIH) and Food and Drug Administration (FDA). The pharmaceutical and biotech industries are well represented at this conference, which is also useful to bring the voice of ME/CFS patients to that sector.

In light of recent election results, the conference organized sessions dedicated to the expectations of, and approaches for working with, the Trump administration. The conference emphasized the system-wide focus on patient centricity, data-sharing, and the role of patients as partners—not subjects—a core belief of SMCI.

You can view the conference agenda here and watch video of the different panels here.

A Candid Discussion with NIH Director Francis Collins

November 18, 2016

carol-zaher-with-francis-collinsEarlier this week at FasterCures’ Partnering for Cures conference in New York, Solve ME/CFS Initiative President Carol Head and VP of Research and Scientific Programs Dr. Zaher Nahle met with Director Francis Collins of the National Institutes of Health (NIH) for a private conversation regarding ME/CFS.

The trio discussed efforts at the NIH to strengthen research on, understanding of, interest in, and clinical studies for ME/CFS. Given the upcoming government transition, the meeting’s focus was on how to maintain progress made so far after the transition and improve outcomes for ME/CFS. Dr. Collins could not offer insight as to the future of his position at the NIH but agreed that the vital progress ME/CFS has made thus far must be protected and bolstered. Dr. Collins acknowledged the past disservice and delay in regard to ME/CFS and committed to continue to support progress moving forward.

Dr. Collins also addressed the recent lecture conducted by the controversial Dr. Shorter and acknowledged the strong response of the patient community. Dr. Collins assured Carol and Zaher that the incident would not impede progress on the disease and committed to ensuring that the NIH would continue to use science and research to guide its decision-making process. Dr. Collins then strongly urged SMCI to continue building bridges in order to bring the ME/CFS community together.

SMCI President Carol Head said of the meeting, “It’s very rare for any disease to receive such a high-level meeting—and we recognize that it indicates Dr. Collins’ commitment to ME/CFS. And at the same time, we cannot predict what will occur if a new NIH director is appointed.”

Dr. Anthony Komaroff’s Responses to Follow-Up Webinar Questions

November 16, 2016

image001On November 10, the Solve ME/CFS Initiative hosted a webinar with Dr. Anthony L. Komaroff, Simcox-Clifford-Higby professor of medicine at Harvard Medical School and senior physician at Brigham and Women’s Hospital in Boston, Massachusetts. Dr. Komaroff has followed up with his responses to the numerous questions that were unable to be answered during the webinar due to time limitations. To watch the full video of the webinar, go here.

Q: To what extent are different researchers with their different focuses converging on a single, generally agreed explanation for the cause of ME/CFS and the mechanism or mechanisms that maintain it?

A: Abnormalities involving multiple organ systems have been identified, and there are theories that could tie together many of those abnormalities, but proving any of those theories is going to take much more work.  In the Webinar, I discussed one theory, about how low-grade inflammation in the brain, or inflammation elsewhere in the body that could theoretically lead to low-grade inflammation in the brain, could be responsible for the symptoms of ME/CFS.

Q: How soon will we see approved drug treatments, and which will be the first to be approved?

A: For drug companies to pursue a drug for ME/CFS, they need a target for their drug to shoot at.  While many different biological abnormalities have been reported in people with ME/CFS, it’s not clear which are central to the illness―and, therefore, good targets.

Q: In light of Fluge & Mella’s success with Rituximab and Cyclophosphamide they commented that in those that have had significant improvement they notice that the gut issues go away. Wouldn’t that suggest that the gut is a secondary issue in this disease?

A: Fluge and Mella, themselves, have not said that these two treatments are “successful”.  Indeed, they said at the IACFS/ME meeting in Fort Lauderdale in late October, 2016, that doctors should hold off using those treatments at least until they complete their current study―which will not end until late 2017. They also said that the treatments do not work for a substantial fraction of patients with ME/CFS. So let’s wait for more evidence before assuming these treatments will help patients―and hope that they prove to be helpful.

I don’t think the research Fluge and Mella have reported thus far says anything about the possible role of the gut microbiome, if I understand your question correctly.

Q: Your portion of the Grand Rounds was excellent, but others were quite not. Why did the Grand Round include recommendations of CBT and GET?

A: If you are referring to Public Health Grand Rounds at the CDC in February 2016, you would have to address your question to the speakers who made that recommendation.

Q: Could the lactic acid increase be due in part to deconditioning?

In most of the studies I cited, the healthy control subjects to whom the ME/CFS patients were compared also were similarly deconditioned.

Q: Were the level of cytokines in the spinal fluid different for patients who had been sick for less than 3 years as well as more?

A: That’s a good question.  The study of cytokines in the spinal fluid did not include enough patients (some ill less than 3 years, and some ill more than 3 years) to answer that question.

Q: Do you think that the electron transport chain is damaged in ME/CFS?

A: Some studies have suggested that its function is impaired.  That functional impairment, if true, doesn’t require physical damage to mitochondria, however, if that is the thrust of your question.

Q: Has anyone examined whether there is a correlation between severity of CFS/ME symptoms with serum levels of histamine? I have evidence of elevated serum histamine in one test and when I do things that cause the release of histamine (e.g. ingest alcohol or sorbitao) the symptoms get worse. I have not seen anything about this in the IOM report or in the other literature that I have been well enough to examine.

A: There is not enough research to answer this question.  During the Webinar, Dr. Nahle referred to a recently-published scientific study (not of patients with ME/CFS) that raised the possibility that histamine biochemistry could be involved in ME/CFS―but this is just a theory. The study was recently published online in Nature Genetics (doi:10.1038/ng.3696).

Q: What is the latest information about using Low Dose Naltrexone as a medicine to help those with ME/CFS?

A: I’m not aware of any large, carefully conducted randomized trials of LDN in ME/CFS.  I hope there will be.

Q: Is celiac disease a common factor in ME?

A: No.  Very few patients with ME/CFS also have full-blown celiac disease.  There is another condition, “gluten sensitivity”, which medical science is only beginning to understand.  I’ve seen some patients (but only some) who have ME/CFS and also appear to have gluten sensitivity.

Q: In the sickness behavior model, whether it is due to persistent infection or persistent inflammation, how could you explain the defect in energy metabolism outside the brain? Is there some sort of signal that the brain sends to mitochondria in order to produce less energy?

A: That’s a very good question, and a recent paper in the journal Cell (doi: 10.1016/j.cell.2016.08.042) suggests that such a signal from a “sick” brain to mitochondria outside the brain is possible.  To be clear, this study was not of people with ME/CFS: indeed, it was a study of a worm.  But that worm has taught us a lot about human biology.

Q: Has this presentation been given to NIH?

A: I spoke at NIH in June 2016, and made some of the same arguments.

Q: Would drug therapies that reduce brain inflammation help with symptoms?  What about gut anti-microbe therapies. Even off-label

A: Theoretically, such therapies might help.  But “inflammation” is a big, complex process, and finding the right inflammatory molecules to target will not be easy.  And until we have solid evidence that the gut microbiome plays a role in ME/CFS―and just what abnormalities in the gut microbiome are responsible―it won’t be easy to develop effective treatments.

Q: What is the simplest way to repair the gut microbiome – beyond Probiotics and whole foods which most of us already take?

A: We don’t know enough yet to answer that question.

Q: Have there been any studies done that compare test results during remission and during relapse?

A: There have not been enough such studies to say anything definitive.

Q: Why does my well-known neurologist still not use the term ‘ME’?

A: The term “ME” is unfamiliar to most doctors in the U.S.  On the other hand, the term “CFS” is now familiar to most U.S. physicians.

Q: I did not hear any study information that addresses the onset of the illness. Are studies not being done that include historic information being collected that would identify any common denominator with the beginning of the illness? ie flu, immunization, environmental exposures

A: There are many epidemiologic studies that have studied how the illness starts.  My summary of these studies is as follows. Studies conducted among patients who come to medical practices that specialize in ME/CFS find that the majority of patients report that the illness started with some sort of “infectious-like” illness.  In community-based studies, where research teams identify people in the community with ME/CFS who may never have sought medical attention, the fraction who say they had an “infectious-like” illness at the start is somewhat smaller.

Q: I live in an area where few doctors recognize ME/CFS as a genuine disease.  Can you suggest ways to increase awareness of this information in this area (Wilmington, DE.)

A: I would suggest that they read review articles about ME/CFS in the medical literature.

Disturbing Steps Backward toward Somatization of ME/CFS

November 11, 2016

psychosomaticThe PACE trial will not go away. In 2011, results were published for a five-year study conducted to determine what therapies, if any, are effective in treating ME. The PACE trial concluded that graded exercise therapy (GET) and cognitive behavioral therapy (CBT) were effective treatments (in other words, the trial concluded that the disease is psychological—rather than physiological—in nature). Almost immediately, ME patients were concerned about the validity of the study methodology and requested additional information. A multi-year legal battle ensued, involving prominent UK institutions. Patients were concerned not only that the study protocols were not sound, but that the results could be harmful to patients.

Before the release of PACE trial data, its authors again published the main results of their study—this time using their original, protocol-specified methods. In this new version, PACE trial’s ostensibly positive results were diminished by two-thirds.

Very recently, with the judicially ordered release of trial data, it is expected that ostensibly positive study results will be even further diminished after they are subjected to independent review. The release of this data allows independent researchers to draw independent conclusions, as is appropriate in rigorous science—a significant victory for patients. Please read our September editorial on the matter, located here, for additional information.

However, the damage caused by the PACE trial lingers.

Recently, articles have been put out by reputable, mainstream media sources (such as BBC News and The Guardian) that have treated ME/CFS as a psychological disease.

ME/CFS has very clear and proven biological (not psychological) traits, which include the following (as well as dozens of other measurable traits):

  • Low natural killer (NK) cell cytotoxicity and compromised immune response
  • Abnormal brain scans
  • Abnormal cognitive-evoked EEG brain maps
  • Up-regulated 2-5A antiviral pathways
  • Prominent activation of pro- and anti-inflammatory cytokines
  • Measureable reduced aerobic work capacity
  • Abnormal gut microbiome diversity
  • Metabolomics and bioenergetics abnormalities
  • Cardiovascular abnormalities

SMCI hosted a webinar earlier this week by Dr. Anthony Komaroff, who outlined overwhelming evidence for the physiological basis of the illness. View Dr. Komaroff’ s webinar, “Hot Areas in ME/CFS Research,” here.

Please also see our other ME/CFS research webinars available on demand here.