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The Pathway to Prevention (P2P) for ME/CFS: A Dangerous Process

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

(See logistics)

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

 
[appeal]?
 

 

 

 

 

 

 

 

{ 25 comments… add one }

  • catly September 25, 2014, 12:03 am

    Absolutely fabulous overview Gabby @Nielk. Thanks so much for this!

  • snowathlete September 25, 2014, 1:20 pm

    It's pretty complicated but you've done a fantastic job of explaining it all – thanks Gabby.
    It looks like the outcome has been decided ahead of time. Whether this is in fact true we don't know but that's part of the problem (a lack of openness and transparency). All their actions suggest they already have things worked out behind closed doors. As we saw with IOM though, even with greater visibility of what's being done, if they don't actually care what patients (and experts) think then it just becomes a farce. It's important to protest against such nonsense. Thank you to everyone doing that.

  • NK17 September 26, 2014, 12:17 am

    Thank you Gabby for this exhaustive review of the P2P. It's very clear that once again we don't have a place at the table and the risk is fairly high that we'll be on the menu. The tiME has come again to dissent and protest.

  • Gingergrrl September 26, 2014, 5:33 am

    I can only also say, thank you Gabby, for taking so much time and energy to compose such a great summary for the rest of us.

  • jimells September 27, 2014, 11:05 pm

    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".

    Dog shows have juries, too, but the jurists are all experts.

    "Jury model" does seem appropriate, though, since by insisting on being sick we are committing a Crime Against Capital, being useless eaters and all. Well, I may be useless, but I'm Not Dead Yet. It's true, I have to take this lying down (no more "I'm not taking this lying down" for me) but I'm going to protest from the comfort of my couch as much as I can.

  • Hate ME/CFS September 28, 2014, 12:42 am

    I have a feeling that the Dec 9 date picked for the NIH/P2P Workshop was purposely chosen. They knew that the stress of the upcoming Christmas Holiday would be more detrimental to CFIDS/ME patients, and that we would be less likely to protest.

  • Kati September 28, 2014, 2:54 am
    jimells

    Dog shows have juries, too, but the jurists are all experts.

    "Jury model" does seem appropriate, though, since by insisting on being sick we are committing a Crime Against Capital, being useless eaters and all. Well, I may be useless, but I'm Not Dead Yet. It's true, I have to take this lying down (no more "I'm not taking this lying down" for me) but I'm going to protest from the comfort of my couch as much as I can.

    i wonder how judge and jury model would have flewn in 1983 with HIV.

  • Nielk September 28, 2014, 10:34 pm
    snowathlete

    It's pretty complicated but you've done a fantastic job of explaining it all – thanks Gabby.
    It looks like the outcome has been decided ahead of time. Whether this is in fact true we don't know but that's part of the problem (a lack of openness and transparency). All their actions suggest they already have things worked out behind closed doors. As we saw with IOM though, even with greater visibility of what's being done, if they don't actually care what patients (and experts) think then it just becomes a farce. It's important to protest against such nonsense. Thank you to everyone doing that.

    It has become a farce, made even more dangerous by the fact that the outcome will be determined by a panel of people who have no know knowledge of ME/CFS. Their "determination" will be based on the faulty review.

    This whole process is doomed for failure for the patient community. As others have said; "it was rigged from the beginning."

  • Nielk September 28, 2014, 10:35 pm
    catly

    Absolutely fabulous overview Gabby @Nielk. Thanks so much for this!

    Thank you! I had a lot of background help from knowledgeable advocates.

  • Nielk September 28, 2014, 10:38 pm
    NK17

    Thank you Gabby for this exhaustive review of the P2P. It's very clear that once again we don't have a place at the table and the risk is fairly high that we'll be on the menu. The tiME has come again to dissent and protest.

    I like the way you put it; "we'll be on the menu". Yes. we'll be toast.

  • Nielk September 28, 2014, 10:40 pm
    jimells

    Dog shows have juries, too, but the jurists are all experts.

    "Jury model" does seem appropriate, though, since by insisting on being sick we are committing a Crime Against Capital, being useless eaters and all. Well, I may be useless, but I'm Not Dead Yet. It's true, I have to take this lying down (no more "I'm not taking this lying down" for me) but I'm going to protest from the comfort of my couch as much as I can.

    I hope everyone reading this will take the time to protest as well as their health allows.

  • 5150 September 30, 2014, 8:17 pm
    Kati
    jimells

    Dog shows have juries, too, but the jurists are all experts.

    "Jury model" does seem appropriate, though, since by insisting on being sick we are committing a Crime Against Capital, being useless eaters and all. Well, I may be useless, but I'm Not Dead Yet. It's true, I have to take this lying down (no more "I'm not taking this lying down" for me) but I'm going to protest from the comfort of my couch as much as I can.

    i wonder how judge and jury model would have flewn in 1983 with HIV.

    It is a huge disappointment that the HIV-AIDS community (which is now being treated in part because People cared & came to their rescue) will not take a role in confronting the same US Govt that would have let them die, were it not for those universal protests.

    We helped them. They won't help us? I am stunned in disbelief.

  • Nielk September 30, 2014, 8:33 pm

    Advocate Eileen Holderman's statement on protesting the P2P, with three addresses of where to send letters of protest.

    From Eileen Holderman:

    In October, 2012, CFSAC made a recommendation to convene a workshop of ME/CFS experts (researchers, clinicians, advocates, and patients) to reach a consensus on a research and clinical definition starting with the Canadian Consensus Criteria (CCC). Instead of implementing the recommendation, HHS told Committee Members in subcommittee teleconferences, they would pursue new definitions their way: NIH would address (in part) a research definition with a workshop (called the EbMW, then called the P2P), and HHS and its agencies would pursue a clinical definition (later identified as the IOM Study). When 3 Committee Members sought information and expressed concerns about the proposed initiatives to redefine ME/CFS, HHS shut down the conversations, then called those 3 Committee Members and threatened to evict them from the Committee.

    HHS continued their secrecy about the IOM and P2P, despite efforts from advocates, patients, and other stakeholders to uncover information about their redefinition initiatives.

    Mass opposition to both IOM and P2P from CFSAC members, ME/CFS experts, advocates, patients, and caregivers sent a clear message to HHS that the majority do not want more Government-sponsored definitions for ME/CFS. Like so many advocates, I agree with our experts that HHS should adopt the CCC in all their agencies and use the money instead for biomedical research.

    Therefore, I will restate and reaffirm, in writing, my opposition to both the IOM and P2P, and will send my letter to HHS for the public record. I will list my reasons for my opposition, without making any suggestions, so HHS is clear that I am protesting, and so they cannot claim stakeholder "buy-in" because I sent a letter.

    Please click on the link to my June, 2014 CFSAC Written/Public Comment which enumerates the reasons for my opposition to IOM and P2P:

    http://forums.phoenixrising.me/inde…holderman-cfsac-written-public-comment.31078/

    If you wish to join the multitudes of advocates, patients, and stakeholders protesting the IOM and P2P, please send your letters of opposition (not suggestions – only your reasons for opposition) to the Government officials at HHS:

    Sylvia.Burwell@hhs.gov (Secretary of HHS)

    Frances.Collins@nih.hhs.gov (Director of NIH)

    Tomfrieden@cdc.gov (Director of CDC)

  • Hate ME/CFS September 30, 2014, 10:27 pm

    The NIH must think that patients have really short memories, of what the NIH and CDC have done to us over the past 30 years, and are willing to forgive and jump on board with the P2P Workshop. This also applies to our so called patient advocacy groups, The CAA and Pandora are too chummy with the CDC/NIH/HHS, and only care about their seat at the table, and not the patients best interests.

  • shahida October 1, 2014, 4:26 pm

    Just confirms what we all know which is that there's a network of people in high places who listen only to a certain other select and exclusive group of people. I wonder how they decided that Pace is worthy- or rather i don't- no prizes for guessing the 'experts' who they communicate with. And it's an international network -they just work to shore each other up and so the 'CFS' merry-go-round goes round and round. And round.

  • twowishes October 4, 2014, 5:27 pm
    Nielk

    Advocate Eileen Holderman's statement on protesting the P2P, with three addresses of where to send letters of protest.

    From Eileen Holderman:

    In October, 2012, CFSAC made a recommendation to convene a workshop of ME/CFS experts (researchers, clinicians, advocates, and patients) to reach a consensus on a research and clinical definition starting with the Canadian Consensus Criteria (CCC). Instead of implementing the recommendation, HHS told Committee Members in subcommittee teleconferences, they would pursue new definitions their way: NIH would address (in part) a research definition with a workshop (called the EbMW, then called the P2P), and HHS and its agencies would pursue a clinical definition (later identified as the IOM Study). When 3 Committee Members sought information and expressed concerns about the proposed initiatives to redefine ME/CFS, HHS shut down the conversations, then called those 3 Committee Members and threatened to evict them from the Committee.

    HHS continued their secrecy about the IOM and P2P, despite efforts from advocates, patients, and other stakeholders to uncover information about their redefinition initiatives.

    Mass opposition to both IOM and P2P from CFSAC members, ME/CFS experts, advocates, patients, and caregivers sent a clear message to HHS that the majority do not want more Government-sponsored definitions for ME/CFS. Like so many advocates, I agree with our experts that HHS should adopt the CCC in all their agencies and use the money instead for biomedical research.

    Therefore, I will restate and reaffirm, in writing, my opposition to both the IOM and P2P, and will send my letter to HHS for the public record. I will list my reasons for my opposition, without making any suggestions, so HHS is clear that I am protesting, and so they cannot claim stakeholder "buy-in" because I sent a letter.

    Please click on the link to my June, 2014 CFSAC Written/Public Comment which enumerates the reasons for my opposition to IOM and P2P:

    http://forums.phoenixrising.me/inde…holderman-cfsac-written-public-comment.31078/

    If you wish to join the multitudes of advocates, patients, and stakeholders protesting the IOM and P2P, please send your letters of opposition (not suggestions – only your reasons for opposition) to the Government officials at HHS:

    Sylvia.Burwell@hhs.gov (Secretary of HHS)

    Frances.Collins@nih.hhs.gov (Director of NIH)

    Tomfrieden@cdc.gov (Director of CDC)

    I know the question of these behind-the-scenes protests is different from the question of any comments in response to the P2P proposal itself, but just wanted to share a few thoughts on the P2P commenting so the issues don't get confused. I believe it's valuable to comment on P2P despite the many fundamental problems, but I also believe those comments will only carry weight if we handle them a particular way:

    Before I got sick, I worked for a federal agency writing regulations with public comment periods.

    We were an efficient and competent division that genuinely cared about protecting the public. And despite that, public comments came so late in the process that our minds were mostly set at that point.

    To be effective, public comments will need to repeat and repeat and repeat just one or two simple points. Ideally we will not just point out the problem, but also offer a solution. We need to tell them, in one voice, EXACTLY WHAT WE WANT.

    Eg, here, we might all say "ADOPT THE CCC." If people want to give supporting points, those points could be "The expert community accepts the CCC (see IOM letter)." "The patient community accepts the CCC (see all these comments)." "Your proposed definition is objectively worse (and that will cause lasting problems)." And maybe "The draft report says there are an estimated million CFS/ME sufferers, most adults never return to work, and yet there are no recognized tests or treatments. Why are we still arguing about definition — when experts and patients already accept the CCC — instead of devoting our time and funds to critically needed biomedical research?" And, in brief, we ask you to ADOPT THE CCC.

    It's hard to know what's going on behind the scenes, and I'm not saying anyone should give up on efforts to shine a light behind the curtain. Keep up with FOIA requests, appeals to political representatives, and all the other invaluable and appreciated advocacy work. But at this point in the P2P process, I think focusing our actual P2P comments too much on the process itself — anything more than maybe a one-sentence "I object to these proceedings because XYZ but am making this comment anyway" — is actually counter-productive. It's not helpful to the people who will evaluate the comments. They are most likely to be swayed (if at all) by precise, specific changes recommended in one voice by the patient community as a whole.

    (So extra thanks to the author of this article and all the advocates helping us understand the details! The more we all understand this well enough to launch a coordinated message, the stronger our voice will be.)

  • Nielk October 5, 2014, 4:24 pm

    Thank you for your comment @twowishes ( intriguing name)

    It is very valuable coming frim someone who has worked inside the government.

    Your points are great. A clear message repeated many times has value. I am all for the message to adopt the CCC because where they are heading with this process will be so much worse.

    Thank you.

  • Gingergrrl October 5, 2014, 8:47 pm
    twowishes

    To be effective, public comments will need to repeat and repeat and repeat just one or two simple points. Ideally we will not just point out the problem, but also offer a solution. We need to tell them, in one voice, EXACTLY WHAT WE WANT.

    Eg, here, we might all say "ADOPT THE CCC." If people want to give supporting points, those points could be "The expert community accepts the CCC (see IOM letter)." "The patient community accepts the CCC (see all these comments)." "Your proposed definition is objectively worse (and that will cause lasting problems)." And maybe "The draft report says there are an estimated million CFS/ME sufferers, most adults never return to work, and yet there are no recognized tests or treatments. Why are we still arguing about definition — when experts and patients already accept the CCC — instead of devoting our time and funds to critically needed biomedical research?" And, in brief, we ask you to ADOPT THE CCC.

    @twowishes That is excellent feedback and really precise and helpful. If everyone here agrees with it, we should create a guideline that people can put into their own words along with the best people & addresses to send our letters to. We can focus on asking them to adopt the CCC criteria and why this will be beneficial and save time and money for future biomedical research.

    I will keep following this thread as it is giving me ideas for what to write (I had been stuck what to do as much as I desperately want to do something to help this process.)

  • mango October 5, 2014, 10:00 pm
    Gingergrrl

    …create a guideline that people can put into their own words along with the best people & addresses to send our letters to.

    this sounds like a great idea. i'm unable to write something from scratch myself, but i'd still love to let my voice be heard.

  • jimells October 6, 2014, 3:18 pm
    twowishes

    I believe it's valuable to comment on P2P despite the many fundamental problems, but I also believe those comments will only carry weight if we handle them a particular way

    Are you suggesting that an actual human person will read email comments sent to agency heads? I just assumed that messages sent to public email accounts are only read by software that looks for key words, or perhaps just sent straight to the "bit bucket" (the modern version of a "circular file", also known as a trash can).

  • Nielk October 6, 2014, 3:44 pm

    Mary Dimmock posted the following review on the 'Review' on Jennie Spotila's blog, Occupy CFS.

    http://www.occupycfs.com/2014/10/06/they-know-what-theyre-doing-not/

  • Gingergrrl October 6, 2014, 10:03 pm
    jimells

    Are you suggesting that an actual human person will read email comments sent to agency heads? I just assumed that messages sent to public email accounts are only read by software that looks for key words, or perhaps just sent straight to the "bit bucket" (the modern version of a "circular file", also known as a trash can).

    @jimells That is a good question and I have no idea if an actual person would read these e-mails or if we just get an automated response that it was received (or not even that?!!!) Does anyone know?

  • Nielk October 8, 2014, 2:19 pm
    Gingergrrl

    @jimells That is a good question and I have no idea if an actual person would read these e-mails or if we just get an automated response that it was received (or not even that?!!!) Does anyone know?

    It seems like the comments will be publicly posted:

    For draft reports, comments will be publicly posted on the EHC Program Web site within 3 months after the associated final report is posted on this Web site. Each review comment on the draft report will be listed with the reviewer's name and affiliation, if such information is provided. Please note that if reviewers include identifiable personal health information, it will be redacted. The report authors' responses to the comments (the "disposition of comments") will be posted on the same Web page as the associated final report.

    You can make comments here.

  • Hate ME/CFS October 9, 2014, 7:28 pm

    Is anybody surprised that our so called patient advocacy groups, Pandora, the CAA and their new pals WPI have endorsed the P2P and the IOM ? I'm not surprised the WPI jumped on board, since their founder is a convicted felon, and they ripped off patients with their bogus tests.

  • jimells October 9, 2014, 8:50 pm
    Nielk

    It seems like the comments will be publicly posted:

    You can make comments here.

    There's too much mush in my head; how is this report related to the "P2P" process? Neither "P2P" nor "Pathway to Prevention appear in the draft report.

    From the draft:

    The artificial neural network test had good ability to discriminate between patients with ME/CFS compared with those without the condition (sensitivity 0.95; specificity 0.85 and accuracy 0.90), but no test has
    been adequately evaluated in a large population with diagnostic uncertainty to determine validity and generalizability.

    What the heck is the "artificial neural network test"?

    Edit: Sorry, "Pathways to Prevention" appears on page 10, but I'm still not sure how the report relates to all the other stuff going on.