Pathways to Prevention for ME/CFS

P2PThere is a lot of activity on a federal level related to ME/CFS –the IOM study, the CDC multi-site clinical assessment of CFS and now the Pathway to Prevention (P2P) initiative through the National Institutes of Health. As all of this activity stands to significantly impact the path forward for ME/CFS research and progress, the Solve ME/CFS Initiative is paying close attention to it all and is engaged where we feel we can lend a positive voice to the discussion.

In the information that follows we break down the P2P program and where ME/CFS is in the approval process so far. The Solve ME/CFS Initiative will pass along additional information as it is received. When there is an opportunity for public comment, we will report that and share the means by which you can effectively participate. If the full approval for the P2P workshop is received, it is estimated to take place in December of 2014.

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The National Institutes of Health (NIH), through the Office of Disease Prevention (ODP) has a program called the Pathways to Prevention, (previously known as the Evidenced-based Methodology Workshop program.) The goal is to host workshops that identify research gaps in a selected scientific area, identify methodological and scientific weaknesses in that scientific area, suggest research needs, and move the field forward through an unbiased, evidence-based assessment of a complex public health issue.1  A P2P workshop can be formed for any disease or condition. Topics are submitted to NIH ODP and are selected by an independent panel based on research need.

You can read more about the P2P program HERE

In June of 2012, the NIH launched the process of including ME/CFS in the P2P program. Several departments within the federal government came together to recommend ME/CFS for a P2P workshop. In November of 2012, the ODP received the recommendation to consider ME/CFS and approved the submission of a full proposal in December of 2012 based on “necessity, urgency and the identification of ME/CFS as a serious unmet medical need and a public health issue. 2

This opened the door to the formation of a P2P working group to be formed in order to draft a full proposal for a P2P workshop. The working group was made up of content experts in ME/CFS – clinicians, researchers, patients, patient advocates, caregivers and Federal partners. Dr Suzanne Vernon, the Solve ME/CFS Initiative’s Director of Scientific Programs, was asked and agreed to serve in this capacity. She was unable to attend the one in-person meeting that was held in January of 2014 due to a scheduling conflict, but she remained moderately involved in the process.

The working group had three major tasks put before them:

  1. Refine questions for an evidence review
    • You can read the refined questions the working group developed HERE, slide 16-18
  2. Develop the workshop agenda (topics, speakers and format)
  3. Nominate panel members

Once the working group completed these tasks, the workshop proposal was submitted for approval. At the time of this writing, the workshop itself has not yet been approved, though an announcement is expected this month.

Should the workshop be approved, it is anticipated to occur in December of this year. The questions proposed for the evidence review will serve to guide the process and focus the work of the P2P. Topics for the two-day workshop agenda are defined by the questions that form the evidence review. Speakers for the workshop are suggested for each question/agenda item. The speakers are all to be experts in ME/CFS and are able to speak to their personal experience and expertise as a patient, caregiver, researcher, etc.

The evidence review is a concise presentation of the ‘evidence’ and literature in ME/CFS (that relates to the study questions), boiled down and presented to the panel. The evidence report has been contracted to Oregon Health and Science University Evidence Practice Center (EPC) through the Agency for Healthcare Research and Quality (AHRQ), a division of HHS. There is an opportunity for the P2P panel to review unpublished data as well. Though we are not yet sure of the process, the Solve ME/CFS Initiative will follow developments and submit pertinent unpublished data available to us as we did with the IOM committee.  The EPC exists to conduct systematic reviews of healthcare topics for federal and state agencies, professional associations, and foundations. These reviews report the evidence from clinical research studies and the quality of that evidence for use by clinicians, employers, policymakers, researchers, and others in making decisions about the provision of health care services and health research. While the EPC does not have specific ME/CFS expertise, they use a Technical Expert Panel made up of ME/CFS specialists and one patient to advise them on the study protocol.

The P2P panel will review the evidence-based report in advance of the meeting (they will receive it approximately 8 weeks in advance), and the report will be released to the public at that time. There will be opportunity to comment and offer feedback on this report.

At the two-day workshop, the P2P panel will hear from the expert speakers and be able to ask clarifying questions in a town-hall-like Q&A that will take place after each session during the meeting.  The P2P Panel will be made up of experts in areas or topics that have relevance to ME/CFS and the evidence based report, but they are not to be ME/CFS experts by design – an effort to avoid bias and produce a report based on the facts presented in the evidence-based report and through the speakers.

The day after the P2P meeting, the P2P Panel will write a draft report, which will be published and the public will have 15 days for comment. Once the comment period closes, the report will be finalized and NIH will organize a robust plan to disseminate it widely. The goal would be to have a report that contains a set of recommendations based on the totality of the evidence, in the hopes of having said recommendations carried out by Federal partners in one-nine months. These recommendations are aimed at improving the robust nature of the research into ME/CFS, while the IOM committee is focused on improving diagnostics for clinical care.

We expect the announcement this month and then the workshop is anticipated to take place in December of this year. The roster of speakers and panelists will not be released until the workshop is approved. The Solve ME/CFS Initiative will pass along additional information as it is received and when there is an opportunity for public comment, we will report that and share the means by which you can effectively participate.

If the full approval for the P2P workshop is received, it is estimated to take place in December of 2014.

Tags: , , , , , April 8, 2014
  • Brett Balzer

    Thank you for the overview.

  • TonyMach

    Prevention? Prevention needs some sense of the cause(s), if I am not mistaken.

    Yes, there are tentative, speculative causes. But all the so far presented “definitive” causes of ME/CFS share one thing in my eyes: complete lack of credibility. There is no trustworthy research pointing to an cause.

    And would prevention look like?

    For pathogens, it would be the prevention of the spreading of that pathogen. Problem is, there is no identified pathogen. Horning/Lipkin draw a blank. So against which pathogen do you want to prevent? Problem is, there are no known ones.

    Sure, the psych*-doctors know that it is the patient who is to blame. Excuse my sarcasm, but to them it is the patient who is doing something wrong, in his/her wicked ways, as patients are – the patients simply “need” guidance by professional psych*-doctors. So their “prevention” would be some form of “education”. Maybe teaching “resilience to fatigue”? Problem is, they think the disease exists in the minds of their patients, but their disease model exists only in the doctor’s heads, not in reality.

    Or do you want to somehow target groups at risk, and do something? Problem is, there are no identified risk groups. (Again pardon my sarcasm) Sure, the psych*-doctors will tell you it is crazy women who are at risk, but that is not reality – everybody is “at risk”.

    Did I miss some school of thought here? Oh, maybe the mainstream nutritional disciples will scare us of cholesterol, or saturated fat, or whatever they think is the current bogey man. Problem is, these things aren’t the cause either.

    So you need some preformed notions about ME/CFS to even consider “prevention”. And the problem is that none of those preformed notions about ME/CFS are in any way backed up by robust studies.

    It is noble to think about preventing ME/CFS, but unless we know more about the cause(s), any talk about “prevention” is pure fantasy, a waste of resources, and potentially quite harmful to the patient.

    Try to find out affected pathways, try to find out cause(s) – and demand loud and clear that any prevention is based on clearly identified pathways and causes. I am afraid that any result of such a conference will be: “Doctors need to teach crazy women how to avoid tormenting their doctors with their problems.” They might formulate it with more psych*-medical jargon, so it doesn’t sound so offensive.

    The CFIDS needs to be highly critical of this – otherwise this could have catastrophic effects on the people with ME/CFS.