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P2P Panel Surprises – Points Out Vast Needs For Chronic Fatigue Syndrome: Pt I

December 29, 2014

The goal of the Pathways to Prevention (P2P) program is to… identify research gaps in a scientific area, identify methodological and scientific weaknesses.., suggest research needs, and move the field forward through an unbiased, evidence-based assessment of a complex public health issue. The National Institutes of Health

In a surprise the P2P panel “got” the major issues facing ME/CFS

The expectations for the Pathways to Prevention report were, to put it mildly, low. The report’s reliance on four outside experts none of whom, by design, had any experience with chronic fatigue syndrome raised fears. Fifty-one percent of respondents in a Health Rising poll felt outside experts probably shouldn’t be reviewing ME/CFS. Sixty-nine percent had low trust that outside experts could be objective, and seventy-nine percent had low trust that the outsiders could get major issues right.

After all the worries over whether the Pathways to Progress (P2P) panel – none of whom had any expertise in this disorder – could possibly “get” chronic fatigue syndrome and, in fact, might set it back for decades, just the opposite happened: the P2P panel actually “got” ME/CFS, and they produced a report which, if implemented, would push it forward significantly.

Coming from independent, outside experts and relying in part on another independent review (AHRQ report), the 19 page draft reports findings – that ME/CFS has been understudied, that patients have borne the consequences of that neglect, and that a vast increase in the commitment to understand and treat this disorder is needed – should have all the more impact. In the end, the data, as Dr. Bateman suggested it would, won out, and Bob Miller’s sense – he was the patient advocate in the early stages of the process – that the panel was listening and working hard ended up being correct.. A review of the first half of the report follows. A review of the critical recommendations section is next.

Medical Community Fails Chronic Fatigue Syndrome Population

The report begins by citing the high rates of disability and economic costs, and then lays the extraordinary burdens people with ME/CFS face directly at feet of a medical community that has essentially failed in its core commitments to assist and provide care. “ME/CFS is an area where the research and medical community has frustrated its constituents by failing to assess and treat the disease and by allowing patients to be stigmatized.”

Medical Community Neglect Leaves ME/CFS Community with Heavy Burdens

Over the last 20 years, minimal progress has been made to improve the state of the science for patients with ME/CFS, and the public and provider community is frustrated. P2P Report

The report evocatively protrayed the burdens the ME/CFS community faces

The panelists “got” to a surprising degree the heavy burdens ME/CFS patients have borne by confronting an often uncaring medical system. It excoriated a medical system that often treats people with ME/CFS with “disdain, suspicion, and disrespect” and considers them “lazy, deconditioned, and disability-seeking”. These outdated and untrue themes, the P2P asserted, have hampered scientific progress and have led patients to be treated inappropriately with psychiatric drugs that have not helped and at times caused harm.

The panel cited the heavy emotional burdens caused by “frequent and negative interactions” with the medical community ME/CFS patients must carry. The stigma that surrounds ME/CFS leads to patients being isolated. Financial distress is common. The report’s statement that the lack of available medical options “usually”, not sometimes, but “usually” requires patients to “make extraordinary efforts, at extreme personal costs, to find a physician who will correctly diagnose and treat ME/CFS symptoms” indicates that the panel understood how underserved this population is, and provides a strong foundation for the ME/CFS community to press for federally sponsored Centers of Excellence.

Inability to Resolve Fundamental Issues Thwarts Progress

“ME/CFS results in major disability for a large proportion of the people affected. Limited knowledge and research funding creates an additional burden for patients and health care providers.”

Fundamental issues thwart the field from getting better results

The report will assert again and again that the failure to resolve fundamental issues has thwarted efforts to understand and treat this disorder. The inability of the research community to develop “consistent, specific, and sensitive” diagnostic tests and criteria (a definition) has, they stated, hampered all downstream research on pathogenesis and treatment, thereby causing harm”.

Citing small sample sizes, problems with the instruments used to evaluate patients, problems defining ME/CFS patients versus others, the report agreed with the AHRQ draft report’s findings that significant methodological problems have thwarted understanding of this disorder. [One sometimes wonders what the field has done right :). In the end, though, it’s not the researchers so much as basic elements they’re missing – validated endpoints, well-funded studies, a clear and concise definition – as well as some things they haven’t been doing (specificity, sensitivity, including other disease groups) that are getting in the way of their efforts bearing real fruit. These critiques may be painful, but they do provide valuable guidelines – and they provide issues the ME/CFS community can use to advocate for increased support.]

ME/CFS “In”

Addressing the “wastebasket” theme held by many researchers and doctors, the panel simply and powerfully stated, “ME/CFS exists” and referred to it as a “distinct pathologic entity” the causes of which remain unknown.

Oxford Definition – Out

Echoing a P2P panelist’s statement during the recent P2P Workshop that the Oxford criteria should be retired, the panel stated that the flawed Oxford criteria were confounding the science by allowing people with other disorders to participate in “CFS” studies.

Inadequate Research Funding Noted

ME/CFS is an area where the research and medical community has frustrated its constituents, by failing to assess and treat the disease and by allowing patients to be stigmatized. P2P report
The report’s highlighting of “the lack of well-controlled, multifaceted studies using large, diverse samples, and the limited research dollars directed at ME/CFS from both the public and private sectors” should prove invaluable in advocates’ quest to finally get an sufficient federal response to ME/CFS.

Disorder Faces Unique Challenges

ME/CFS faces challenges other disorders do not face

Remarking on the “unique challenges to ME/CFS” the panel appeared to understand, as well, that they were dealing with a disorder that faces challenges that few other disorders do. When asked how to foster innovative research to produce treatments they noted that twenty years of research has produced scant progress leaving patients frustrated.

ME/CFS is Not a Psychological Disorder

Patients want … a meaningful recovery (not just incremental improvement) P2P Report
Importantly, they asserted that, while psychological repercussions often follow ME/CFS, it is not a psychological disorder. ME/CFS overlaps with many other disorders including fibromyalgia, major depressive disorder, and a variety of chronic pain or inflammatory conditions. [Finally, inflammatory disorders are included as a co-morbid condition.] Fatigue is an essential component, but does not nearly begin to “capture the essence of this complex condition.” The panel got the constellation of important symptoms right: fatigue, post-exertional malaise, neurocognitive deficit, and pain. The panel did not [and could not in my opinion given the lack of studies in this area] endorse a single definition for ME/CFS, but their statement that a “clear case definition with validated diagnostic tools is required” will enhance efforts to get the NIH to fund studies to produce a statistically determined research definition that will propel this field forward. Their statement that it is “critical” to include homebound (“non-ambulatory”) patients in studies will, hopefully, spark efforts in that area as well.

CBT/GET Downplayed

CBT and GET….are not a primary treatment strategy. P2P Report
The Panel took the very moderate findings from the AHRQ draft regarding CBT/GET and moderated them even more, stating, in what will be music to many ears, that because neither therapy shows improvement in quality of life, they should not be considered “ a primary treatment strategy”. (The CDC Toolkit, in the P2P panel’s eyes, now contains no primary treatment strategies.)

Doctor’s Lack Basic Understanding

Most doctors lack basic knowledge of the disorder

Doctors lack understanding of basic management skills (pacing, realistic goals, basic rights, understanding of emotions, exercise, relaxation) that can be helpful. Too strenuous exercise programs in the past have turned some patients off to milder, more appropriate exercise regimens (they mentioned stretching) that can be helpful.

Laundry List of To Do’s

The laundry list of “to-do’s” for ME/CFS is long indeed and feature basic research elements this field has not yet produced or hasn’t had the money to utilize. Standard and validated tools and measures are missing, studies are too small to identify subgroups, endpoints need to be clarified, and clinically meaningful symptoms are not being assessed. In perhaps a critique of the European emphasis on behavioral studies, they noted that the biological factors causing and promoting ME/CFS are often neglected in research studies.

Promising Avenues for Future Research Cited

In contrast to the AHRQ’s report that simply wiped out most ME/CFS research findings because of methodological problems, the P2P draft report asserted that “strong evidence” indicatesthat the potent avenues for future research include the immune system, metabolism (exercise), the mitochondria, neurotransmitter signaling, and the microbiome [but not the autonomic nervous system?]. Their call for large, multi-center studies with diverse groups of patients (to replace the small studies typically done now) can only help advocates’ efforts to increase funding. Research priorities should focus on finding biomarkers and developing treatment options. Key research needs include:

Determining the pathogenesis of ME/CFS, in particular the role herpesviruses and other viruses play in triggering the disorder is critical. Encouragingly, the authors plucked out the role infectious mononucleosis (IM) plays in adolescents. (This should be included to include the role IM during adolescence plays in adults coming down with ME/CFS later.) They also highlighted

  • Understanding that the genetic predisposition present.
  • Is ME/CFS a spectrum disorder?
  • Are different pathways responsible for different symptoms?

Conclusion

“We noted … the limited research dollars directed at ME/CFS from both the public and private sectors. P2p Report”

In a surprise, the panel of outside experts – none of whom had any experience with ME/CFS – mostly “got it” about ME/CFS. Any report will have shortcomings and this one will as well, but the list of ways the panel got it right is impressive. The report suggests that, given enough time and information, outside experts can be trusted to understand.

ME/CFS faces many challenges. Next up – the Panel’s recommendations…

Halfway through the Pathways to Prevention report, it’s identified many barriers to progress and has provided the ME/CFS community ample opportunities to press the federal government for change. The panel is in agreement on many longstanding issues that advocates have asserted plague ME/CFS, including paltry public and private research funding, lack of knowledgeable doctors, poor patient care, and a stigmatization of ME/CFS the medical community has fostered and allowed to continue.

The report downplays the significance of CBT/GET treatments, states the Oxford Definition is causing more harm than good, and, in agreement with the AHRQ report, provides a list of basic issues that need to be resolved. The future research section missed some points (such as the autonomic nervous system) and may have over-emphasized others, but it always focused on pathophysiology.

The report got the major issues right. We’ll see how they do in the all important Future Directions and Recommendations section next.

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3 Comments

  • Pam

    January 9, 2015 at 3:13 pm - Reply

    I note that there are multiple sclerosis studies taking place in Australia to treat people who got ms due to EBV. Using vaccines they successfully improved the lives of an ms patient:
    http://www.msaustralia.org.au/news/queensland-researchers-make-major-breakthrough-ms-treatment

    I think a ebv study similar in some ways is being done for ms patients in US.
    Why aren’t there similar studies taking place for people who got cfs after mono? I wish we could get on with this. Why should cfs patients have to wait so many years? what is wrong with now?

    • Cort Johnson

      January 9, 2015 at 5:33 pm - Reply

      Didn’t know that – thanks for pointing that study out Pam (I see a blog forming :)) – and I think that’s a great study you have – and if we get increased funding – I imagine that it or something like it will happen..

  • Pam

    January 9, 2015 at 11:09 pm - Reply

    Maybe several private wealthy donors could come forward and if they or their loved one meets the right criteria (CFS after mono), then they should be the ones to receive this experimental treatment. Might be incentive.

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