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More on P2P

January 13th, 2014

Robert Miller posted a statement on Facebook last night revealing that he was one of the members of the P2P Working Group that met at NIH last week. I’ve posted his full comment below, with his permission.

Bob is very positive about the meeting and P2P process. I’ve spoken with several people who attended this meeting, and I have heard mixed reactions. Some are positive, some quite negative. The members of the Working Group are all, as Bob says, some of our best experts. Bob says that NIH listened to their input, and that the Working Group “drove the agenda” for the P2P Workshop. Again, I have not heard the same optimistic assessment from everyone who attended the meeting.

As I said before, there are two fundamental problems with the P2P process:

  1. The P2P panel cannot – by design – include anyone who has ever published on ME/CFS or taken any position on it. The Workshop could be exactly as Bob and the other Working Group members designed, but non-experts will do the evidence review and non-experts will comprise the entire Panel. That Panel will write the final recommendations, not the Working Group or meeting presenters.
  2. There is no transparency. I am very glad Bob came forward to acknowledge his participation in the Working Group. But the questions they finalized at the meeting have not been made public. The roster of the Working Group has not been made public (although word is leaking out). My understanding from two people who attended the meeting was that the discussions at the meeting were confidential. While Bob and the Working Group nominated potential panelists, the actual selection process will be done in secrecy. We will have no input, and no idea who those panelists are until the meeting is about to happen.

This is not acceptable to me.

We are constantly admonished not to question the motives of the people involved in these efforts. I do not question anyone’s motives, nor have I seen evidence of a conspiracy. I agree with Bob’s view that we should engage in these issues in a positive and professional way. My advocacy “career” is based on those values.

But a P2P Panel that will not include any ME/CFS experts? A Panel that will be selected behind closed doors? An evidence review conducted by non-experts? And the outcome of the process is a series of recommendations on diagnosis, treatment and research? No, no, no, and no.

The ME/CFS advocacy community would never have accepted an IOM committee that had no ME/CFS experts on it. We already know that the P2P panel will involve no ME/CFS experts. I do not accept this, and neither should you.

People have asked me what we can do about it. I am actively pursuing several options, and I will keep you posted.

Here is Bob’s statement from Facebook last night:

A brief update for everyone: last week I was invited as a patient representative to the NIH Working Group meeting for the NIH Pathways to Prevention Workshop on #MECFS (happening in the future). This is what was described as an Evidence-based Methodology Workshop at last Spring’s CFSAC meeting. I was asked at the last minute because the original patient advocate could not attend. The Working Group was charged with preparing questions for a thorough evidence-based literature review to identify gaps in ME/CFS scientific research, and we recommended expert speakers and independent panel members for the workshop itself. You can find details of the P2P program below. It is an independent scientific review, and the same process has been used before with another illness.

I want everyone to know my perspective. The Working Group was composed of some of our best experts, and I developed real respect for the person who will Chair the independent panel. Our experts and I had real input into the agenda and questions. The Working Group drove the agenda, and we will participate in the Workshop. I believe the prep work for the Workshop is being done with strong representation from our illness, laying the foundation for a good outcome.

I have been pretty ill in recent months, so I have been stingy with my energy. It has been difficult to post a lot about what is happening in our illness. With this NIH Workshop in mind, and the other governmental initiatives occurring in ME/CFS, I want to encourage patients to engage positively in federal work on our illness. We have had 25 years of inaction by the federal health agencies, and that hasn’t been good for us. All of us have asked for a serious commitment to ME/CFS by the federal government. That is what President Obama promised my wife. These initiatives – the FDA Drug Development Workshop, NIH Pathways to Prevention Workshop, Institute of Medicine Diagnostic Criteria Panel, the CDC’s 5 year Clinical Assessment Study – are all steps toward a stronger federal response. All of these initiatives are not an accident – they are the result of years of work by many of our patients and advocates, to change the federal approach for the better. Patients educated the FDA last spring in a way that has never happened before, and we have the same opportunity at the IOM meeting coming up. The IOM has strong representation on the ME/CFS Committee because patients engaged in it. We need to mix our expert clinicians & scientists with new experts in relevant fields of biomedical research to change our health. I welcome all of these initiatives and know that we will have to do hard work on the details. We won’t agree with everything in these processes or outcomes, but we need government support and action to improve diagnosis, treatment and understanding of ME/CFS. I continue to believe we need to Unite to make the most of new government attention and that 2014 will be a turning point in so many ways. Happy New Year to every one who suffers from ME/CFS. I promise we will move forward together in 2014!

  1. Billie Moore
    January 13th, 2014 at 10:32 | #1

    Jennie, is it possible to get one or more of the less-positive attendees to comment publicly? It would be extremely helpful to learn what the other viewpoints are. Bob is one of our very best advocates, and I am grateful he came forward with his views. But your analysis from the beginning has revealed the alarming aspects of this P2P study. As long as non-experts are going to make the final determination for diagnostic criteria, treatment, and research, AND the entire process is secret, we need as much insight into this redundant, wasteful, and unnecessary study as possible.

    Billie

    • Jennie Spotila
      January 13th, 2014 at 14:41 | #2

      My understanding is that the participants were asked not to discuss this publicly. The person who had a less than positive view does not want to speak publicly at this time. I asked.

  2. May Twelfth
    January 13th, 2014 at 10:45 | #3

    Bob’s statement says experts are involved while your statement says they are not. Which is correct?

    • Jennie Spotila
      January 13th, 2014 at 14:43 | #4

      Both. Bob is absolutely correct that the Working Group planning the meeting is all experts. Bob is also correct that the presentations at the Workshop will be given by mostly experts (as far as I can tell). However, the PANEL that oversees the actual meeting and writes the final report will be NON-experts. That is the design of the P2P process. The panelists are non-experts.

  3. AJ
    January 13th, 2014 at 13:08 | #5

    First: I can understand secrecy if this were a company developing a new product. But this is the government. This is a global health concern. Secrecy should have no place at the table.
    Second: Again, if this were about developing and marketing a new product, having non-experts on a (test) panel would make sense. But this is a serious neuroimmune disease, not a new commercial fad!

  4. Ess
    January 13th, 2014 at 14:51 | #6

    I am a very positive person–however, I am also a REALIST.

    Positivity can spring of DESPERATION in so wanting change FOR THE BETTER–which of course ‘we’ do–YET the cards are STACKED AGAINST THIS/US — with all the evidence and growing evidence that we have talked about.

    What we need–is to deal in REALITY–OF THE MANNNNY MANY R E D flags–and the INTENDED outcome BEHIND THE SECRECY AND CLOSED DOORS . . . leading the herd of buffalo to the cliff and OVER they–WE–go!! Let us NOT be USED in this way — let us NOT be FOOLED!!!!!!! This is POLITICS, folks!!

    We gotta KEEP FIGHTING!!

    Thank you, Jennie, for reporting this!

  5. Ess
    January 13th, 2014 at 15:31 | #7

    P.S. — AND, what’s that saying, that strategy—‘go for the WEAKEST link’ !!!

  6. Michael Allen
    January 13th, 2014 at 16:47 | #8

    I am baffled. How do you work on “preventing” M.E. when the work has not yet been done to understand the cause and/or pathophysiology of the disease? Without that work the only so-called “evidence-based” research available is GET and CBT.

  7. Gabby Klein
    January 13th, 2014 at 19:25 | #9

    You can ‘prevent’ M.E. by never defining it in the first place.

  8. Ess
    January 13th, 2014 at 23:07 | #10

    It seems that you PREVENT ME by BURYING it and making it go away thusly . . . !!!!! You see–they’ve got all the answers and THE PLAN !!!!

  9. Justin Reilly
    January 13th, 2014 at 23:28 | #11

    Thank you Jennie for being proactive on this extremely important issue. You are entirely right that this process is much more flawed than the IoM process. Please keep fighting it.

    I do wonder why you aren’t ‘questioning anyone’s motives.’ How much evidence of bad faith do you require?

    • Jennie Spotila
      January 14th, 2014 at 10:49 | #12

      People can do the wrong things with the best of intentions. And people with bad intentions can accidentally do the right thing, or do the right thing for the wrong reasons. What matters to me is action and results. I don’t know the NIH players personally, so I don’t think I can make judgments about whether their intentions are good or bad. Everyone involved in the P2P process could be acting with great care and pure motivation to help people with ME/CFS. That in no way changes my concerns about the process.

  10. jhillman
    January 14th, 2014 at 19:08 | #13

    Through out this vauge end undefined P2P process the words (“Evidence Based Medicine” “EBM”) pop up inter’changeably with “Science Based Medicine.(SBN)”

    Evidenced Based Medicine (“EBM”) is a term to denote scientific appearing research which has no origins in science at all. The development of “somatic illnesses science” is been based upon that non-scientific mound of non-science.

    No on has been able to prove that a particular disease has been caused by “wrong thinking”, for example. No one, I have found, in my research has been able to show that any person’s illness is paychosomatic, i.e. based upon their thinking rather than a disease the cause of which is yet unknown, or at least unknown to a particular doctor.

    Those who push the psychosomatic as a cause of illness, do this, by basing their unproven reasoning upon “Evidence Based Medicine.”

    If you have M.E. or “cfs” and you hear “EBM” tossed about, Run or Fight or get the hell out of the way. EBM is the new Witchcraft.

  11. Anonymous
    January 14th, 2014 at 19:28 | #14

    Everyone, if you’re concerned about the P2P panel, WRITE THEM. This doesn’t mean you need to write a new letter; just cut-and-paste your comments into their form:

    http://prevention.nih.gov/contact_us.aspx

    Select Pathways to Prevention in the dropbox. It matters not just what you write but that you get the complaints to the appropriate people so you have a chance to be heard. Writing on Jennie’s blog or other forums is great for discussion but please send your comments to the government as well.

  12. Mary Dimmock
    January 14th, 2014 at 22:47 | #15

    Gabby
    “You can ‘prevent’ M.E. by never defining it in the first place.” I got a very dark laugh out of that line.

    Jennie – excellent update. Thank you.

    To your two points…
    No experts
    No transparency

    I would add
    No clarity
    a) on what disease they are actually studying
    b) on how they intend to deal with an evidence base that uses the same label, “CFS”, for such a diverse set of unrelated conditions and poorly defined criteria.
    c) on how the IOM will coordinate with P2P – what information will be shared with IOM and when

    We’ve seen what non-experts have done in other evidence based reviews of the “CFS” evidence base. That’s how we ended up with CBT and GET as treatment recommendations for ME patients.

    You are so right to be concerned.

  13. Justin Reilly
    January 15th, 2014 at 06:57 | #16

    @Jennie Spotila
    I hear what you’re saying and think you’re right. However, in the case of HHS and ME, it is very clear from the whole consistent pattern of activity over 30 years, that they are trying to muddy and retard ME science, which is obviously a bad motive and in bad faith. Since that is their main goal with regard to ME, and the P2P is yet another extremely flawed process, it is almost certain that their motive is bad in this case as it is with regard to ME generally. Res Ipsa Loquitor; their actions speak for themselves.

  14. Ecoclimber
    January 16th, 2014 at 19:05 | #17

    @Jennie Spotila

    Using HHS & IOM’s Evidence Base Criteria or ‘EBM’ – APA DSM-5 “the best predictor of future behavior is past behavior”, one must conclude that thirty years of HHS, CDC, NIH’s behavior would indicate that people with bad intentions taking bad action with bad results on a vulnerable population.

    Let’s not forget the U.S. Public Health Service 40 year ‘Tuskegee syphilis experiment’ .https://en.wikipedia.org/wiki/Tuskegee_syphilis_experiment and others!

    But then we have this ‘promise’ or policy statement.

    My administration is committed to creating an unprecedented level of openness in government. We will work together to ensure the public trust and establish a system of transparency, public participation, and collaboration. Openness will strengthen our democracy and promote efficiency and effectiveness in Government.

    — President Barack Obama

    http://www.whitehouse.gov/the_press_office/TransparencyandOpenGovernment

    One would than assume that people within President Obama’s administration are running amuck under his watch especially in light of the ACA rollout.

    HHS does not need to hire an outside PR firm, they just need to adhere to the policies and guidelines of this administration as quoted on the WH own website through their actions.

  15. January 17th, 2014 at 20:42 | #18

    Get these idiots on the panels and committees to view the medical and scientific facts about ME and CFS at http://www.me-ireland.com And put the recommended diagnostics and treatments into place nationally, and set up ME centers of excellence in most states to treat patients. And provide the research funding recommended on the aforementioned web site. They need to stop talking and start doing, and start getting things now.

    They have sat on their asses at HHS, CFSAC, NIH, IOM and other bodies for 20 years talking bullshit and doing nothing and achieving nothing. While their brainless cheerleaders on some blogs and some organisations cheered them on for doing nothing. I will acquire the emails and phone numbers of these fools, and I will help them learn basic science and math, and about legal obligations of civil servants.
    I would fire 50% of these fools on the first day and frighten the rest of them into doing their work in the process. We need results, not more talk and bullshit.

  16. Ess
    January 17th, 2014 at 23:34 | #19

    WELL SAID, David Egan–this ME/CFS FIASCO / ‘circus’ in an ‘ongoing’ game like a dog chasing its tail and getting NOWHERE . . . and WORSE (no offense to the doggies) as we p/w ME/CFS CONTINUE to be WRONGFULLY subjected in DEBILITATING illness, time and time again, to go thru various DEAD-END hoops–is a complete SHAM.

    There are no ifs, ands, buts nor excuses for this ONGOING OUTRAGEOUS MALtreatment AGAINST p/w ME/CFS!! Let us NOT ‘play the game’ ENABLING this PERPETUATING CYCLE AGAINST US to continue as we fight for our very LIVES!! Let’s cut the ‘bullshit’ — yes, THAT is MORE than TRANSPARENT!!!

    Amazing, isn’t it–this CRUEL, OPPRESSIVE, PREJUDICIAL and INHUMANE treatment towards persons with ME/CFS in this 21st century AMERICA ?!? –an HORRENDOUS CRIME AGAINST HUMANITY / against us–right in our own back yard!! I wouldn’t have believed that such abomination could be transpiring; yet, as a person in DEBILITATING DAILY SICKNESS HOUSEBOUND with ME/CFS, YEAR after YEAR, that is EXACTLY where we find ourselves–held HOSTAGE in this DECEITFUL POLITICAL MEDICAL NIGHTMARE.

    The ANSWERS are CLEARLY and EASILY laid out in David Egan’s first paragraph above–it is really quite SIMPLE.

  17. January 18th, 2014 at 23:13 | #20

    Jennie, is there anything about the P2P program’s process that is substantially different than the decades-old Consensus Development Program that you mentioned last March?

    • Jennie Spotila
      January 19th, 2014 at 07:06 | #21

      The old program was rebranded and reorganized. As far as I can tell, the program is emphasizing prevention and noncontroversial diseases.

      It’s total speculation on my part, but I wonder if we’re still in this program because we were in before they rebranded. I don’t see ME/CFS as fitting the program criteria. If they booted us out because of the program changes, NIH would have to come up with money for the meeting another way. But I’m speculating.

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