What is the purpose of the ME/CFS P2P meeting at NIH? You would think that we would know by now, since Assistant Secretary Dr. Howard Koh first announced the effort in October 2012. But to say the rhetoric has evolved over time would be a kind description.
HHS keeps changing the answers to questions about the purpose of the workshop, what kind of research is on the table, and whether the ME/CFS experts have meaningful input.
To me, it looks more like a bait and switch where the meeting sounded better the further back in time you look, and key information (like the panel being 100% non-experts) was withheld until the very last minute. The reality of this meeting is very different from the picture they portrayed early on.
Are we making a research case definition or not?
First they told us the workshop would create a new case definition:
The NIH has made a commitment to conduct an evidence‐based review of the status of ME/CFS research and also convene a dedicated workshop to address the research case definition for ME/CFS. Dr. Howard Koh, October 3, 2012 CFSAC Minutes, p. 5.
To address the highest priority identified, which was “case definition issues,” the Working Group submitted a competitive application for an Evidence-based Methodology Workshop (EbMW) on ME/CFS coordinated by the NIH Office of Disease Prevention. May 1, 2013, Response from Dr. Howard Koh to CFS Advisory Committee, p. 3
Then they told us it wouldn’t:
The purpose of the Pathways to Prevention Program and the ME/CFS workshop is not —and I repeat, not—to create a new case definition for research for ME/CFS. Dr. Susan Maier, December 11, 2013 CFSAC Minutes, p. 16.
But in the middle, they said the meeting might help with a research case definition:
This will not create a research case definition in the end, but will inform anyone who wants to do research in this area about what aspects of the case definition are really strong, which are really lacking, and how those holes might be filled. Dr. Beth Collins-Sharp, May 23, 2013 CFSAC Minutes, P. 16.
But the meeting is about research, right?
The answer might depend on the day, and the person you ask. Here are the research-oriented answers:
The purpose of an evidence-based methodology workshop is to identify methodological and scientific weaknesses in a scientific area and move the field forward through the unbiased and evidence-based assessment of a very complex clinical issue. Dr. Susan Maier, May 23, 2013 CFSAC Minutes, p. 6.
The takeaways from a systematic review are answers to the key questions that identify where there’s strong evidence, where there are gaps, and some ideas about how those gaps may be filled. Those are called research recommendations. Dr. Beth Collins-Sharp, May 23, 2013 CFSAC Minutes, p. 13.
It has the potential to be both [research and clinical], but understanding that we are a research organization and our focus is to improve the, um, the integrity of the science that is used for translation into clinical care means that we have to focus on besting the science that is used for the evidence. Dr. Susan Maier, Institute of Medicine Public Meeting, January 27, 2014, Minute 0:19.
Bob Miller, who served on the P2P Working Group, certainly thinks the meeting is about research:
NIH is hosting a Pathway to Prevention workshop to identify gaps in scientific research, to guide a path forward for NIH research. Bob Miller, March 11, 2014 CFSAC Transcript, p. 114.
But at other points, it appears the focus is back on the case definition:
The purpose of the Pathways to Prevention Program for ME/CFS is to evaluate the research evidence surrounding the outcome from the use of multiple case definitions for ME/CFS and address the validity, reliability, and ability of the current case definitions to identify those individuals with or without the illness or to identify subgroups of individuals with the illness who might be reliably differentiated with the different specific case definitions. Dr. Susan Maier, December 11, 2013 CFSAC Minutes, p. 16.
Doesn’t this assessment of multiple case definitions and what research tells us about subgroups sound like what the IOM panel is doing right now? And if IOM is already doing this, why do we need a separate process at NIH where the decision makers are ALL non-ME/CFS experts?
The expert gets to decide, right?
I went back through CFSAC minutes and other documents, looking for the first time Dr. Maier or another federal employee told an ME/CFS audience that the P2P Panel would be composed entirely of non-ME/CFS experts. It was January 27, 2014 in her presentation to the Institute of Medicine, when Dr. Maier offered her ill-fated “jury model” analogy. Dr. Susan Maier, Institute of Medicine Public Meeting, January 27, 2014, Minute 6:25.
Just to be clear, the earliest public discussion of P2P was October 2012, but it wasn’t until almost 16 months later that Dr. Maier finally told us that the P2P Panel would have no ME/CFS experts on it. Why did it take so long? Maybe the better question is why January 2014. Would Dr. Maier have talked about her jury model of “They don’t know, they don’t know anything” if I had not already exposed this here on January 6, 2014? Maybe, but it strikes me as more than odd that despite at least two opportunities to tell CFSAC about the “jury model,” she waited until the IOM meeting to actually disclose it.
But the government says Don’t Worry! Your experts are participating!
The working group will meet to develop the questions that will form the basis of the evidence-based review, develop workshop themes and structures, suggest speakers, and develop an agenda for the meeting. The deliverable from this meeting will be a list of questions for the evidence review, themes for the workshop, perhaps a draft agenda, and any speaker names for those who will speak at the meeting. Dr. Susan Maier, December 11, 2013 CFSAC Minutes, p. 16-17.
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. Bob Miller, January 12, 2014.
It sure sounds like that Working Group finalized the questions for the evidence review:
The Key Questions were defined by the Working Group of content experts at a planning meeting organized by the NIH Office of Disease Prevention. May 2, 2014 Email from CFSAC listserv.
There’s a problem, everybody. Multiple sources who are in a position to know what happened at the January 2014 Working Group meeting told me that the questions in the study protocol were not the questions defined at the meeting. Did something happen between that January meeting and the release of the study protocol? I don’t know whether someone continued to tinker with the questions, or why the Working Group was not consulted. But either the questions have been significantly changed, or the information from my sources is deeply flawed.
Why is this a problem? Well, in addition to all the problems I documented with the study protocol, those questions form the structure of the P2P Workshop. Those questions give us a pretty good idea of what will be on the Workshop agenda, and I will supplement that with additional exclusive information in my next blog post.
Regarding P2P, I’m reminded of my favorite M*A*S*H character, Colonel Flagg:
“I keep myself in a constant state of confusion so the enemy can learn NOTHING from me!” Sadly, like Flagg, P2P is not likely to produce much actionable intelligence. And apparently, the enemy is us.
Colonel Flagg, indeed!
Thank you, Jennie, for sharing this. It’s disturbing, but we need to know.
More of the subterfuge–we know that the IOM and P2P are not there to help the ME/CFS community. All of these ‘activities’ smack of that from the get-go of HHS ramming in the IOM contract. This is why we continue to call for a STOP to the IOM contract, inclusive of the P2P jury model.
I couldn’t agree more with the analogy that the disease of ME/CFS and, therefore, ME/CFS patients/people are seen as the enemy by HHS, CDC, NIH and affiliates–as we continue to be targeted in harmful acts and roadblocks against getting to the biological truth of ME/CFS.
STOP IOM–adopt CCC as per the experts. The HHS IOM contract is harmful to patients. And the evidence just keeps piling up–lies, deception, cover-ups.
@Joe Landson
Joe, I hope you get to say that whole statement sometime in a public, recorded session. That says it all. CFSAC?
Billie
Thank you, Jenny, for this update on this totally frustrating situation. Very glad you are up and able to write this up, which signifies, hopefully, that you are feeling better.
Either this is confusion, and the right hand doesn’t know what the left hand is doing — that is an optimistic view. Or it’s deliberate, with the government hoping that the ME/CFS community will buy into the smoke-and-mirrors act that is being perpetrated.
Whatever it is, we’ll never stop advocating for ourselves and all others who suffer from this debilitating disease. And we won’t go away!
This was planned all along. No one should be surprised. We haven’t been able to trust those agencies for 30 years, why should we start now? Foolish!
And don’t be fooled by our “supposed” researchers who are involved, they continue to use the word “fatigue” when it suits them because they want that research money.
Those “supposed” researchers do the same thing when it comes to CBT and GET.
People need to open their eyes. Don’t give these people 1 inch of slack ever!.
They have proved over and over again how much they really care about this patient community. That Systematic Review should be a slam dunk as far as proof!
When it comes to these agencies, remember this saying:
“Fool me once, shame on you; fool me twice, shame on me.”
Setting aside the expert/non expert issue and whatever and follows from January 2014 Working Group meeting, I’m not seeing profound inconsistencies in the various quotes, particularly when judged in chronological order.
*****
Koh’s statement to CSFAC October 2012, emphasises “status of research” and “research case definition” as the points of focus, followed in May 2013 by identification of “case definition issues” being the highest identified priority.
Collins-Sharp at May 2013 says [P2P] “will not create a research case definition in the end, but will inform anyone who wants to do research in this area about what aspects of the case definition are really strong, which are really lacking, and how those holes might be filled.”
Collins-Sharp at May 2013 identifies purpose [to provide] “answers to the key questions that identify where there’s strong evidence, where there are gaps, and some ideas about how those gaps may be filled”
Maier at May 2013 affirms purpose “is to identify methodological and scientific weaknesses in a scientific area and move the field forward”.
Maier in December 2013 states that the purpose of P2P is “not to create a new case definition for research”.
I don’t read this as being in contradiction to Koh, but allows that “case definition issues” can/would be addressed without the creation of a new research definition. This is consistent with Collins-Sharp and is surely is only stating the obvious – that case definitions for CFS research are imperfect and that an aim of P2P is to make the imperfections baldly stated.
Maier at December 2013 also stated “the purpose [of P2P] is to evaluate the research evidence surrounding the outcome from the use of multiple case definitions for ME/CFS and address the validity, reliability, and ability of the current case definitions to identify those individuals with or without the illness or to identify subgroups of individuals with the illness who might be reliably differentiated with the different specific case definitions.”
Maier at January 2014 says purpose is “to improve the, […] integrity of the science that is used for translation into clinical care”.
Miller at March 2014 says “workshop to identify gaps in scientific research, to guide a path forward for NIH research.”
*****
The P2P process may be flawed, but it seems to me that Koh, Maier and Collins-Sharp have been consistent in maintaining that while case definitions are an issue, the purpose of the P2P was not to create a new case definition but to assess and present what the problems with existing case definitions are.
Of course if one has already arrived at a position that a particular definition/set of criteria is unchallengeable then P2P will axiomatically be flawed and/or redundant. My own view is that at this stage any ME/CFS case definition/criteria will include wide ranging problems and it is desirable that these should be made explicit so that all researchers are making informed choices based on fully acknowledged limitations.
I agree that it is desirable for the wide ranging problems with all the case definitions be made explicit. But is that not part of what IOM is already doing? And don’t the researchers and policymakers in the field already understand those problems, especially given the work of Lenny Jason on those problems?
I’m concerned that this process is not the appropriate process for such an inquiry. My reading of the systematic review protocol is that there are gaps in what they will examine that could shed light on the case definition issues, such as the exclusion of OI research done with pediatric patients. Furthermore, they are beginning with the assumption that all the case definitions describe the same entity – and that strikes me as a dangerous assumption.
The charge to the Panel is unclear. Will they be asked to restrict their recommendations to the comparative strengths and weaknesses of the case definitions? Or will they be invited to go beyond that and make recommendations on the name, education and treatment (as the PCOS Panel did)? The lack of transparency in the process raises red flags for me.
That being said, I think you make a good point in examining the statements in order to see if the evolution makes sense.
Jennie, you ask “What is the purpose of the p2p?”
I think as ME/CFS patients, we should be very thankful and grateful to HHS for their three pronged simultaneous works to benefit us.
Being such a patient, I understand that as soon as I became ill with this vague syndrome, I instantly relinquished my capacity for intelligent thinking. This has been evident each and every time I have had the pleasure of having consultations with doctors relying on the CDC for CFS knowledge. I should therefore be happy to defer to those in the government who know what is best for me.
I am confident in this way of acceptance since the HHS has proven time and again in the past 30 years that they are champions for the rights and welfare of patients like me.
How could I ask the HHS to involve the patient/advocate community in their processes when clearly it would backfire on us? We should be thankful that this whole process is kept in the dark and is totally confusing. Then again, maybe it’s not confusing at all. Maybe we just can’t grasp its complexities, being that our brains are compromised.
Whether the purpose of p2p is to discover a fine clinical or research definition, we can rest assured that the outcome will be extraordinary. How do I know this? Because HHS has assured me that they are superior to the 50 super intelligent experts in the field.
In the past, I have trusted the experts who work and treat patients with this illness but, Dr. Koh etal has
proven that they have superior knowledge by ignoring and decimating the request by the 50ME/CFS experts to adopt the CCC now.
Who am I to argue with such highly evolved cerebral power? After all, I am a lazy malingerer with a compromised brain.
To go back to the initial question “What is the purpose of the p2p”? I have no worries. I have faith in the highly evolved system of the HHS.
“The Thirty-Six Stratagems was a Chinese essay used to illustrate a series of stratagems used in politics, [and] war…
Mask your real goals, by using the ruse of a fake goal, until the real goal is achieved. Tactically, this is known as an ‘open feint’: in front of everyone, you point west, when your goal is actually in the east…
bribe an official to turn traitor…
Encourage your enemy to expend his energy in futile quests while you conserve your strength. When he is exhausted and confused, you attack with energy and purpose…
A plain lie… create an illusion that something does not exist, while it does…
Revive something from the past by giving it a new purpose or bring to life old ideas, customs, or traditions and reinterpret them to fit your purposes…
Create confusion and use this confusion to further your own goals…
Tying silk blossoms on a dead tree gives the illusion that the tree is healthy. Through the use of artifice and disguise, make something of no value appear valuable… of no use appear useful…”
http://en.wikipedia.org/wiki/Thirty-Six_Stratagems
You just blew my mind. Seriously.
@N.A.Wright
With NO experts.
@Ren
This ’36 Stratagems’ is precisely what we have been trying to spell out!
Thank you for finding this, Ren.
EYES WIDE OPEN. The 36 Stratagems is exactly what TPTB have laid out and are counting on . . . in throwing out ‘busy work,’ ‘priming select patients,’ etc., etc.–HHS is counting on a seriously ill ME/CFS patient population to desperately grasp at any little bogus nugget/straw thrown our way–that means absolutely nothing–to their predetermined outcome–all the while trying to make this circus look like they are doing something to help the ME/CFS community.
B O G U S.
Let’s hope more of us, despite desperation and some ‘wanting to believe in the (goodness of–HAH!) HHS, CDC, NIH, et al because ‘maybe this time . . .’–HAH!!– are awakening to this ’36 Stratagems’ strategic planning, manipulation, deceit, lies and cover-ups set up against the ME/CFS patient population.
The use, abuse, neglect and deception of 30 years is at an all-time high with the HHS IOM contract and P2P.
Ohhh, yes, they like this one too–united they/we stand–divided they/we fall. There is power in numbers; it is to their orchestrated ADvantage with deception to cause confusion–divide and conquer–play one against the other . . .
Those in abusive power know exactly ‘who to play, how and when’ . . . They use egos, strong points and weaknesses in others to manipulate them as the situation fits–whatever ploy fits and works for their agenda. They are absolute pros at what they do!
This is a big game to them, TPTB. Agenda–lock ME/CFS away–crush us with a dose of CBT, GET and throw in some anti-deps on the side. And then say . . . Ohhh, there, there, we tried. Hey–we used $1M + on the IOM and P2P; that must count for something. B.S.
The IOM contract and P2P jury model are a HUGE waste of money and a waste of precious time and resources in our lives.
Majority of NON-ME/CFS experts on the IOM committee–and NO experts on the P2P, all hand picked–TPTB knowing who to play, how and when.
Why do you think the 50 ME/CFS Experts and Researchers, in an unprecedented action, sent that letter in the fall of 2013 to then HHS Secretary Sebelius calling for the STOP of the IOM contract, warning of harm to the ME/CFS patients with an IOM re/definition of ME/CFS–and the 50 ME/CFS Experts and Researchers also called for the adoption of the CCC–Canadian Consensus Criteria? Can you not see what is going on? It is just so very clear.
This is our LIVES on the line here.
EYES WIDE OPEN.
Thank you again, Ren, for finding this!!
Someone (maybe Gabby?) on PR mentioned Sun Tzu’s “The Art of War” sometime ago, and so the idea of that has stuck with me – though I haven’t yet explored that text.
But Joe’s post #1 (above) MASH reference made me think of the warfare angle again, and that’s how I happened upon “The Thirty-six Stratagems”.
It does make for a very interesting and eerie lens.
@Jennie Spotila
I don’t want to be an apologist for P2P – I’m a UK resident and therefore removed from the immediate impacts of what happens in the US, though I expect the IOM and perhaps also P2P to have long term effects well beyond the US borders. The UK doesn’t have the ‘consultative’ tradition of the US so it’s interesting from here to see it in play. It does surprise me that the level of distrust and at times outright disdain that patients have for a system that seems to a least give them some kind of voice. And I can’t help but think that the a priori adoption of a very negative position must have an impact upon the way that consultative processes work.
But I certainly take your point about the lack of clarity in terms of what the Panel is being asked to do, although I wouldn’t see any problem with cross over with the IOM, so long as the P2P restricts itself (as its spokespersons have repeatedly said it will) to issues of research. If it does go on to cover issues other than research aspects I would have thought those would be open to complaint and challenge given what Koh, Maier and Collins-Sharp have said.
Assumptions about what it is that particular case definitions are identifying should certainly be made with great caution, but that applies to patients as well administrators and researchers. If we accept, as I think we now must, that ME etc covers a range of disease processes, such that we need to consider that a number of disease spectra are in play, then the possibility of any one case description/criteria set actually exclusively circumscribing a distinct patient group, is very slim.
I really appreciate hearing your perspective (regardless of where you live!), and offer a few additional points.
This is a very very important point. The distrust many people feel comes from years of having their voices ignored. I think some patients feel they have tried to work within the system, with little to no results. The way certain actions have been pursued without any stakeholder input, and frequently over stakeholder objections, contributes to that frustration.
The systematic review protocol includes treatments. The P2P Workshop will discuss treatments. The PCOS report (the only other disease to go through the P2P process) included comments on the name, diagnostic criteria, treatments, education, AND research targets. So there is a risk – if not a surety – that the P2P will go beyond identifying gaps in research (which were already identified at the 2011 State of the Knowledge meeting).
I agree with this statement. Unfortunately, the systematic review protocol does NOT assume there are a number of disease spectra and processes. It lumps ME and CFS and ME/CFS and all the associated definitions into one bucket.
@Ren
“The Art of War” ? health advocacy for the Hikikomori generation where World of Warcraft counts as a social interaction ? Though perhaps the doctrine of parsimony is intended with the avoidance of conflict being the higher aim ?
@N.A.Wright
Lest we forget–so let’s remember–the unprecedented act of the 50 ME/CFS international Experts and Researchers writing to the HHS in the US with all their expertise and and knowledge advising the HHS to STOP the IOM contract and to adopt the CCC; they know of what they speak–and they warned of harm to patients with said IOM contract.
Their expertise and advice were politically and completely ignored, disregarded and disrespected. There was NO good reason–for ME/CFS patients, that is–to ram in the ‘IOM’ contract–a political entity that doesn’t define diseases–except recently with the Gulf War Illness–and a complete sham was made of that. There is much detail involved.
quote
It does surprise me that the level of distrust and at times outright disdain that patients have for a system that seems to a least give them some kind of voice.
unquote
Key word here is ‘seems’ and ‘to at least give them some kind of voice.’ It is all a political farce and set-up. And, yes, therefore, huge levels of distrust and outright disdain–as to further burying ME/CFS for another 30 years. We are in the fight for our lives and those lives globally!
It is outright appalling what is happening in the US and elsewhere with ‘politics’ of the biological disease of ME/CFS. We have rights to meaningful health care and to be able to live our lives and be productive members of society–all that stolen from us with ME/CFS–and the medical mistreatment of p/w ME/CFS.
We are ever grateful to the ME/CFS Experts, Researchers and other doctors and those invested in getting to the REAL answers for ME/CFS. This is ever more important as the numbers of ME/CFS patients rise globally with the spread of ME/CFS; and that is of utmost concern.
My head’s a bit loopy today, so please any repeats, etc.
@ N.A. Wright: EU aquaintances have commented that Americans (US) question government motives/directives more than Europeans. That’s an opinion and can be debated, etc. of course. But I believe it contains some truth. On the other hand, I’ve experienced that Europeans can have a much healthier distrust of industry motives/directives than Americans. I know these are very general statements, but maybe it helps inform a larger picture or sense of being or seeing the world.
I would never say, for example, that a system gives me a voice (comment 15). That’s honestly unthinkable to me. I have a voice, as does each human. It’s an inalienable right, and anything that silences that voice is unjust, period. Others obviously may not share my views…
Regarding comment 17, I’m sorry I don’t understand all the references, or perhaps there were other misunderstandings. I believe the “Art of War” is 2500-3000 year old Chinese text with so-many strategic truths, so to speak. To my understanding, it’s assigned reading in military schools and universities around the world, and people use it as a lens, again so to speak, for law, business, military, politics, etc.
I don’t know how or if The Thirty-six Stratagems overlaps with the above text. But I thought it (The Thirty-Six Stragems) correlates very well with the history of ME/CFS and the community’s general allegations of wrong-doing on the part of government, researchers, doctors, insurers, etc.
If past is prologue, then The Thirty-six Stratagems makes a very interesting prologue for the history of ME/CFS – especially when at least one of the key players (key writers) has an education and professional life that involves military history.
And even if it were all complete coincidence (like monkeys typing Shakespeare), then it’s still not a good outcome when a healthcare plan resembles classic Chinese war theory. :/
Please “forgive” any repeats – or omissions! Ha!
Why are we held accountable for paying our taxes on time, when our government sees no obligation to stick to the timeline and the agenda? Why is a corporation held accountable for what their employees mistakes? Because there are laws that say they are. Why is our government not adhering to the same laws they set for this nation, accountability by their agencies such as the P2P (NIH) IOM, CFSAC, to the administrative branch of our government?
As usual, the right hand doesn’t know what the left hand is doing. It is evident that government representatives will say what ever they want to say because they don’t feel they will be held accountable.
What about the promise President Obama made to Bob Miller’s wife?
I signed up for the Listserve for CFS and haven’t received a thing in probably the last year. Granted, I have my hands full as advocate for chronic pain patients and fibromyalgia, but as a FM and ME/CFS patient, I want action.
TY Jennie for keeping your finger on the pulse. Let us know if there is something we can do. I recently wrote to “the powers that be,” and the nominee for Sec. of HHS. Funny, I never hear a word other that three of the some 12 people I addressed were out of their office.
Celeste, I am putting the finishing touches on an action that others can support. Details by the end of the week!