Gabby Klein gives an overview of the P2P process, shedding light on the pitfalls with advice as to what we can do in protest …
Right after I wrote this article, the draft review was made public HERE. We have started a thread HERE on Phoenix Rising in order to discuss this review. The review in its final form will be the evidence presented to the P2P panel in advance of the Workshop in December.
Comments will be accepted till October 20th – HERE.
What is the P2P?
The National Institutes of Health (NIH), through the Office of Disease Prevention (ODP) has a new program called the Pathways to Prevention (P2P).
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
- Move the field forward through an unbiased, evidence-based assessment of a complex public health issue
(More HERE)
What are the stated goals of the P2P for ME/CFS?
The 2014 Pathways to Prevention Workshop: Advancing the Research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome will seek to clarify:
- How the research on ME/CFS using multiple case definitions has contributed to the state of the current scientific literature on diagnosis, pathophysiology, treatment, cure, and prevention of ME/CFS
- How the measurement outcomes (tools and measures) currently used by researchers of ME/CFS are able to distinguish among those patients diagnosed with ME/CFS, including the sensitivity of the tools and measures to identify subsets of patients according to duration, severity, nature of the illness, onset characteristics, and other categorizations
- How the research on treatments or therapies shown to be effective in addressing symptoms of ME/CFS will lead to an understanding of the underlying pathology associated with ME/CFS
- How innovative research approaches have provided an understanding of the pathophysiology of ME/CFS
- How this knowledge can be applied to the development of effective and safe treatments
(More HERE)
Timeline for the process
Approval to Implementation: 12 to 14 months
1) Proposal Review and Approval – 8 weeks
2) Workshop Planning and Implementation – 9 to 12 months
- Organizational meeting (Dec. 9, 2013 )
- Working group meeting (January 6, 2014 – Agenda)
- P2P workshop – 2 day presentation (Dec 9 & 10, 2014)
3) Dissemination and Follow-Up – 1 to 9 months
Comparing the P2P to the IOM process
The P2P and IOM processes are similar in that both have been initiated and charged by the Department of Health and Human Services (HHS).
The stated goal of the IOM was to complete a review of diagnostic criteria and available evidence, for the purpose of making recommendations for a new clinical definition for ME/CFS.
The original stated goal of the P2P was to complete an evidence-based review to address research case definition for ME/CFS. This goal was later changed to the following vague description; “identifying gaps in scientific research in order to guide a path forward for NIH research.”
In addition to the review, the P2P process includes a workshop. Each of these segments carry with it their own mechanism of input.
The IOM panel consists of some experts and non-experts in ME/CFS (about 50/50 ratio). We were given advance warning as to the potential members with time for comment from stakeholders. However the comments didn’t seem to have any bearing on the resulting panel.
The P2P workshop panel is made up solely of non-experts. The makeup of the P2P panel has been concealed from us.
The IOM process allowed for two meetings that were open to the public (only one allowing for opposing views). Those open meetings allowed for measured stakeholders input such as comments from patient groups, as well as brief comments from advocates and patients.
The only open meeting presented by the P2P will be the workshop in December. As far as we know, only one patient will have 20 minutes for comment.
We were just notified that there will be a 3.5 hour discussion time where public input will be allowed at the workshop. Questions and comments will be facilitated via microphone for the live audience, as well as the ability for webcam viewers to type in comments and question in a comment box on the webcast.
Specific problems to consider with the P2P
The criteria used by the P2P are too broad based
The P2P for ME/CFS is using an evidence-based search on a very broad “fatiguing” definition of the illness:
“Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a complex, multifaceted disorder characterized by extreme fatigue and a host of other symptoms that can worsen after physical or mental activity, but do not improve with rest. In addition to extreme fatigue, people with ME/CFS may also experience:
- “Widespread muscle and joint pain
- “Sore throat
- “Tender lymph nodes in the neck or armpit
- “Headaches
- “Sleep problems
- “Difficulty with short-term memory or concentration”
This description is indeterminate. It only requires “extreme fatigue” as a mandatory symptom, with a choice of one or more additional symptoms. This definition can easily include an array of “fatiguing” illnesses such as depression and somatoform conditions.
In addition, one of the original questions that the P2P was charged with, was to consider whether CFS and ME are one disease. This question was later removed from the list of targeted goals. The key question as to whether ME and CFS are the same disease or a set of related diseases will not be considered. Not only has this question been removed from the review process but, it does not appear on the workshop agenda.
Advocates Jennifer Spotila and Mary Dimmock have sent a 32-page packet to Dr. Collins of the NIH pointing out their concerns. This has been met with a meaningless reply. (What a surprise!)
Jennifer has extensively warned about the dangers of this process on her blog “Occupy CFS”. (Please see links at end) Jennie and Mary have stated that the most important question that will not be addressed by the workshop is the following:
“How do ME and CFS differ? Do these illnesses lie along the same continuum of severity or are they entirely separate with common symptoms? What makes them different, what makes them the same? What is lacking in each case definition – do the non-overlapping elements of each case definition identify a subset of the illness or do they encompass the entirety of the population?”
(P2P: The Question They Will Not Ask)
According to Jennifer, this question was previously posed and then mysteriously disappeared. She elaborates on this problem further:
- “The P2P description of ME/CFS refers to it as a single disorder or illness throughout the meeting webpage.
- “The P2P website characterizes the names myalgic encephalomyelitis and chronic fatigue syndrome as synonymous.
- “Every section of the Workshop agenda lumps all the populations described by the multiple case definitions together, discussing prevalence, tools, subsets, outcomes, presentation, and diagnosis of this single entity.”
The question they should be considering is: are all the ME and CFS definitions being examined in this evidence review clinically and/or biologically equivalent? Lumping them all together as if they are all the same does not make scientific sense. It is therefore disturbing that this important question has been removed from the goals of the project.
We need to keep in mind advocate Eileen Holderman’s judicious words in her testimony at the June 2014 CFSAC meeting:
“HHS’s mission is to redefine ME/CFS with yet another broad, erroneous case definition, which will include countless people who do not have ME/CFS, so they can recommend CBT, GET, and anti-depressants, and so they can bury the scientific, biomedical evidence of ME/CFS. HHS will then not have to fund research into this biomedical disease or fund clinical trials or pay for long term disability and other Government entitlements. Once HHS develops their new definition and name for this disabling, neuroimmune disease, they will embark on their next phase of (mis)educating the medical and scientific communities, the press, and the general public. HHS is acting in bad faith toward the ME community.”
This is a huge red flag and is one of the reasons why all MECFS stakeholders are concerned and are tirelessly working to protest the P2P process and to shine a light on its pitfalls.
The “unbiased” workshop panel
According to the NIH:
“The panel is an unbiased, independent group composed of 8-10 members that gives balanced, objective, and informed attention to the topic. The panel members must have no vested financial or intellectual interest in the topic under review.”
By design, this workshop panel is made up of non-experts in ME/CFS. Unlike with the IOM, we have no way to check on the panel members’ objectivity and/or bias because we were not told who they are. The members of the panel will be revealed to us on the day of the workshop.
The NIH states that the members will be “nonbiased” but, it is most likely that this claim is hard to prove since many non-experts still have some biased opinions about ME/CFS. Even CFSAC members who we were told are non-biased have been shown to have preconceived ideas. (I.e. it is a disease of depression and/or a somatoform disease)
When Susan Mayer was challenged about the fact that the P2P panel will be made up of non-experts, she explained that it is like a “jury model”.
Advocate and attorney, Jeannette Burmeister, wrote on her blog “Thoughts about M.E.” regarding this jury model:
“In the P2P process, the jury model is stood on its head entirely. There is no judge to explain to the P2P panel of non-ME/CFS experts what the ‘law’ is or to screen the evidence presented by the OHSU or the presenters at the workshop. Rather the panel is supposed to determine and confirm what the “law” is from what undoubtedly (or maybe hopefully) will be an abundance of highly technical information presented by OHSU in its evidence review.”
The failure to engage the MECFS community in the process
The P2P process has failed to engage stakeholders in a meaningful and substantive way. Most of their sessions are closed to the public. The work group meeting had some experts and one patient advocate in presence but, feedback from some on that panel reveal that they feel they did not have much impact on it.
From the agenda for the December two-day workshop, there is only one time slot for one patient’s input. There seems to be a time slot for questions at the end but, we do not know if they will engage the audience at all.
We are told that the workshop panel will get the draft evidence review in a closed session about six weeks before the meeting. This review will be published and there will be a four-week period for public comment on it.
A small group of advocates have done some preparatory work on this, and will be advising us on the process and how we can participate with our own comments. We will publicize this upcoming opportunity on Phoenix Rising when the information becomes available. *
The day after the workshop meeting, the P2P Panel will write a draft report which will be published. There will be a 30-day period for public comments. The usual 15-day period has been extended to 30 days due to pressure from advocates. This period will be followed by the finalization and dissemination of the plan.
The bias of a systematic evidence-based review
An evidence-based review, whether performed by the IOM or P2P for ME/CFS, is a dangerous process.
The Solve ME/CFS Initiative wrote the following in their letter to the NIH regarding this problem with the P2P process:
“there are serious flaws with the sample search strategy” for the systematic evidence review, and that the search “will bias the evidence base to [psychological and exercise treatment] trials … and will fail to assess any of the important biomarker research.”
In the paper titled “How evidence-based medicine is failing due to biased trials and selective publication,” authors Susanna Every-Palmer and Jeremy Howick argue that EBM’s potential for improving patients’ health care has been thwarted by bias in the choice of hypotheses tested, manipulation of study design and selective publication.
Evidence for these flaws is clearest in industry-funded studies. “We argue EBM’s indiscriminate acceptance of industry-generated ‘evidence’ is akin to letting politicians count their own votes.”
What do advocates think?
Most advocates feel that we should protest the P2P just like we did with the IOM. They feel that these processes have been designed by the government health agencies in order to de-legitimize the disease, myalgic encephalomyelitis.
Advocates point out that there is no transparency in these processes. They have been set up with an end result in mind: “make ME go away.”
The ME/CFS experts have voiced their opinion that the Canadian consensus is the best working definition we currently have, and that it should be immediately adopted by all for diagnostic and research purposes.
In addition, there is no need for two separate set of criteria and it is a waste of much-needed funds which could be better used to finance research into the disease.
What has been done so far?
The advocacy community has been actively campaigning against the P2P process as a dangerous course for ME/CFS patients.
Letters have been written to the NIH in protest.
A twitter campaign (#StopP2P4ME) has been launched against the P2P process.
A patient wrote a letter to Public Citizen for an emergency injunction.
Some have been campaigning on the Hill and contacting congressional leaders.
CFSAC members’, patients’ and advocates’ testimonies have spoken up against the process publicly, yet the process is moving forward unhindered.
See Jennie Spotila’s blog HERE.
Some advocates are urging patients and stakeholders to attend the workshop in December. They feel that we need to impress on them that we are taking this very seriously and our concerns are legitimate and need to be heard. There is the fear that if they don’t see a great presence, it might be taken as a sign of agreement.
Most are in total opposition to the P2P and feel that we should not participate in any form. They feel that we should send in letters of protest and that, as promoted by our own experts, we should urge them to adopt the Canadian Consensus Criteria (CCC) now and put a stop the IOM and P2P processes.
Please see the statement from advocates Eileen Holderman and Jeannette Burmeister HERE.
What can you do?
You can read up about it and become educated. (See the links below)
You can join the weekly twitter campaign (#StopP2P4ME) every Saturday. (click HERE)
You can register to attend the workshop on December 9 and 10, 2014. (click HERE)
You can register for the webcam to listen in to the workshop. (click HERE)
You can write to the NIH in protes and telling them what your concerns are. (click HERE)
You can contact your congressional representative informing them of the dangers of the P2P process and how it can adversely affect you.
Registration for the Pathway to Prevention (P2P) workshop for MECFS is now open. Stakeholders may register to attend live or participate via webcast.
The workshop: when and where
The workshop will take place on December 9 and 10, 2014 at the NIH offices:
Location
Natcher Conference Center (Building 45)
Main Auditorium
45 Center Drive
National Institutes of Health
Bethesda, Maryland
301–496–9966
To register to attend live click HERE
To register for the webcast click HERE
Links for further reading:
NIH P2P website link for ME/CFS – click HERE
Solve ME/CFS Initiative stand on P2P – click HERE
PANDORA and six organization letter to NIH regarding P2P – click HERE
Jennifer Spotila and Mary Dimmock: letter to NIH regarding P2P – click HERE
All P2P articles on Occupy CFS – click HERE
The Other Side of the Stretcher: Twitter storm campaign against P2P – click HERE
Why the NIH P2P systematic review is negligent – click HERE
ME Advocacy campaign against P2P (form letter to use) – click HERE
MECFSForums campaign against P2P – click HERE
CFS Treatment Blog against P2P – click HERE
Health Rising article against P2P – click HERE
The Other Side of the Stretcher: Why The NIH Pathways to Prevention Systematic Review is Negligent – click HERE
Thoughts About M.E.: P2P review Protocol Still No transparency – click HERE
Thoughts About M.E.: P2P Patients to Purgatory or the Jury Model Stood on its Head – click HERE
Onward Through the Fog: P2P Question They Will Not Ask – click HERE