(Thanks to Jennie Spotila for allowing Health Rising to republish her Nov 10th blog originally titled “P2P and Dr. Francis Collins”. Our most prolific advocate ,Jennie’s in-depth investigations regularly reveal flaws in the federal governments approach to chronic fatigue sydnrome. If you’re interested in advocacy at all be sure to sign up for her blog.
In this blog she demonstrates federal officials flailing about first in response to a blog “Unfulfilled Commitments / Broken Promises: The NIH and Chronic Fatigue Syndrome After Twenty Five Years” that exposed the federal governments declining support for ME/CFS and then to Director Collins subsequent inquiry. )
On January 3, 2014, just three days before the P2P Working Group meeting, a troubling series of emails was exchanged among NIH leadership. These emails show confusion at the leadership level about the ME/CFS, P2P and IOM efforts, and a narrow concern from Dr. Francis Collins himself about the topics for P2P.
I obtained these emails through FOIA. I’ve posted the emails for you to read in their entirety, but the organization can be confusing. The emails are also heavily redacted, which I have appealed. In this post, I’m using a narrative format because it is critically important that every ME/CFS researcher and advocate understand this story. Bottom line? No one in charge seemed to understand what was going on, and the implications of that are frightening.
On January 3rd, Cort Johnson’s article about the dramatic decline in NIH’s commitment to ME/CFS over time appeared on ProHealth, and a note about the article appeared in the NIH internal news summary that day. This prompted Dr. David Murray (Director of the Office of Disease Prevention) to email his staff to ask for their input on a draft email to Dr. Francis Collins about the P2P meeting. The draft is redacted, as is a comment from staff member Jody Engel.
Dr. Murray then sent the following email to Dr. Collins (copying four other staff members in the Office of the Director):
I noticed the item in today’s news briefing regarding chronic fatigue syndrome. The report suggested that NIH was falling behind in this area.
Let me alert you that ODP has been planning a workshop on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) as part of its Pathways to Prevention workshop series for more than a year. Jim Anderson was involved in the initial proposal development and selection of the Working Group members. Janine Clayton and Susan Maier at ORWH have been involved from the outset. The first meeting of the Working Group is scheduled for Monday, January 6 and the target date for the workshop is Fall 2014.
We generally don’t publicize these workshops until they are further along in the planning and have HHS approval, but I wanted to share this with you so you were aware.
This is pure politics. The planned P2P Workshop in no way changes or addresses the decline in funding that Cort discussed in his article. The Workshop does nothing to avert the trajectory of NIH falling behind on ME/CFS, especially in light of everything else NIH is refusing to do. Dr. Murray saw an opportunity to put his office’s work forward, and he did.
Almost immediately, Dr. James Anderson emailed Dr. Murray and said,
Remind me- the goal of the ODP WS is to provide a research definition for ME/CSF [sic]. We are not wandering outside that box. The IOM meeting [redacted].
This is remarkable. NIH had been saying quite clearly at CFSAC meetings that the purpose of the workshop was not to come up with a research definition. Yet here is the Director of Program Coordination, Planning, and Strategic Initiatives saying the precise opposite. Before replying, Dr. Murray turned again to staffer Paris Watson and said, “I need to clarify the purpose of the workshop. It is supposed to be used to [redacted].” Is Dr. Murray asking Watson because he doesn’t know the purpose of the workshop?! This is precisely what we’ve already documented: the purpose of the P2P meeting has shifted over time and NIH has made contradictory statements about it. Apparently, this is true internally as well.
Shortly thereafter, Dr. Murray responded to Dr. Anderson, saying in part, “The goal is to address methodological issues that are holding up research in this area. So the working group will tackle the issue of what diagnostic criteria should be used in research for ME/CSF [sic].” Anderson then replied:
I think Francis needs a follow-up email explaining how the NIH and IOM goals are different. Our goal is to provide a more useful definition of ME/CSF [sic] so that our research investments produce the highest quality and valid results. [redacted]
I don’t think any ME/CFS researcher or advocate is under the illusion that the Director of NIH has our disease forefront on his mind or agenda. There’s not enough money involved for that to be the case. But I find it troubling that Dr. Collins needed an explanation of how the “NIH and IOM goals are different.” Given the controversy, and given NIH’s role as a primary funder of both initiatives, shouldn’t someone have already briefed Dr. Collins on this – or at least his senior leadership staff?
Dr. Murray turned his attention to drafting a follow-up email to Dr. Collins, again relying on Paris Watson and Dr. Susan Maier. There are some significant and troubling statements in the resulting email:
Jim Anderson suggested that I follow my earlier note to [redacted].
Our P2P workshop will review the various definitions for ME/CFS that have been used in research studies to clarify the type of patients that are captured under each definition and how those patients respond to various therapeutic options. This will inform future research by providing a better understanding of the implications of choosing one definition over another as studies are being designed. Our audience will be researchers working in ME/CFS.
The IOM effort will also review the various definitions for ME/CFS but their goal is to recommend diagnostic criteria and case definitions for clinical care. Their audience will be health providers, patients, and caregivers, not researchers.
Our planning had been underway for sometime when we learned of IOM’s interest in this topic. We have been communicating with them to avoid duplication of effort. They have invited Susan Maier from ORWH to their first meeting to discuss our P2P Workshop “in an effort to minimize overlap and maximize synergy.”
First, note the promise that P2P will clarify which patients are captured under each case definition and how that affects response to treatment. Whatever the plan was in January 2014, we now know that P2P will not do this. The evidence review made no such distinctions and lumped all the case definitions together. There is no indication that anyone is going to address the question of how case definition predicts response to treatments. Second, note the statement that IOM’s audience is not researchers. Does this signal an intention that researchers not use the IOM output? Fukuda was intended as a research definition, but it’s been used clinically for 20 years. If IOM produces an accurate and precise case definition, shouldn’t researchers be the exact audience that needs to pay attention to that? Finally, Dr. Murray admits that the P2P planning was underway for “sometime” when they learned of the IOM’s “interest” in the topic. In other words, there was NO coordination between the P2P and IOM ideas, as many of us suspected.
Finally, Dr. Francis Collins responded to the emails from Dr. Murray:
Thanks for the heads up. I hope there will be some attention to the microbiome as part of this CFS workshop.
I will admit that when I first read this email in the FOIA packet, my jaw dropped. Out of all the ME/CFS issues, including case definition (which Dr. Collins himself personally noted was a problem at the 2011 State of the Knowledge Workshop), what he asked about in January 2014 is the microbiome. Why?
I can only speculate, but perhaps the answer lies in what Dr. Ian Lipkin told Mindy Kitei in May 2014. Dr. Lipkin, whose effort to find funding for his ME/CFS microbiome study is well-known, said, “I’m on the advisory committee for Francis Collins, and I can tell you that Francis Collins, the director of the NIH, believes that chronic fatigue syndrome is a problem.” Have Drs. Lipkin and Collins discussed the microbiome study? Have they discussed the poor scores given to Dr. Lipkin’s grant proposal by a reviewer who said ME/CFS was a psychosomatic illness? Personally, I hope they have discussed it, but for this topic to be Dr. Collins’ “hope” for the workshop strikes me as myopic, at best.
As one would expect, an email from the Director of NIH received immediate attention. Dr. Murray quickly asked Dr. Maier and Paris Watson if the microbiome was in the plans for the P2P workshop. Dr. Maier responded, “I am sure that the microbiome will be discussed as part of the scientific content at the actual workshop, however, the purpose of the P2P really is to help determine the extent of evidence surrounding the case definitions . . . “Dr. Maier also quickly told Dr. Murray and Dr. Anderson that “Microbiome is playing a larger role in ME/CFS research, with at least 2 of 16 projects following this approach as the primary objective, and others with a smaller focus on microbiome in general.”
Simultaneously, Deputy Director of NIH Dr. Lawrence Tabak emailed, “As I recall HHS was planning on sponsoring a workshop on this in FY14 that NIH is a co-sponsor of; Janine [Clayton] may know the details – if not I can find out.” And now confusion really spins out of control.
Dr. Murray, now quite flummoxed, emailed staff member Wilma Peterman Cross in part,“Francis raised the issue of the microbiome and Larry raised the specter of yet another workshop. I am trying to find out if this ‘other workshop’ is the IOM meeting. I hadn’t intended to spend most of my morning on this . . . ” Turning again to Dr. Maier and Ms. Watson, Dr. Murray asked, “Do either of you have information on this? Is this the IOM workshop that the 3 of us have been trading notes about this am? Or is there a third workshop being developed that I haven’t heard of.”
Ok, let’s pause for a minute. NIH is co-sponsoring the IOM study under their contract with the National Academy. The IOM contract had been controversial for months, and Dr. Maier was scheduled to speak at the IOM meeting in just three weeks. Yet the Deputy Director of NIH had no idea what is going on with it, Dr. Collins needed an explanation of the difference between IOM and P2P, and now Dr. Murray had to scramble to figure out if there was a third meeting he was not aware of. Am I surprised? No. Is it disheartening to see how far off the radar ME/CFS is? Absolutely.
Dr. Maier, one of the only NIH staffers who appeared to know what was going on, replied,“Yes, the 2014 workshop from HHS is the IOM workshop/study. Those are the only 2 I know about other than a potential in house one at NINDS looking at brain fog in general.” Dr. Murray then sent a final email to Dr. Collins and Dr. Tabak, repeating what he said before about the P2P vs. IOM effort and saying, “Francis…At least two currently funded projects on ME/CFS address the microbiome. That topic is very likely to come up at the P2P workshop in the fall.” Of course, we now know that the microbiome is just one of many categories of ME/CFS science that will not be discussed at the Workshop.
These emails are a telling snapshot of NIH leadership’s scramble, on the eve of the P2P Working Group planning meeting, to figure out the purpose of the P2P meeting and its difference from the IOM study. Even the Director of the ODP – the office charged with running the P2P Workshop – does not seem to understand the purpose of the Workshop and how it fit (or failed to fit) with other NIH efforts.
Furthermore, Dr. Collins’ only response to the blurb from Dr. Murray about the P2P Workshop is to say that he hopes the microbiome will be covered. Even if Dr. Collins is not tracking ME/CFS (and I doubt he is), how could the microbiome be the foremost issue in his mind? As I said, Dr. Collins attended the 2011 State of the Knowledge Workshop and acknowledged the importance of resolving the case definition issues. He sat and listened to Dr. Suzanne Vernon summarize the gaps in research and the issues that needed attention. But in January 2014, he only mentioned the microbiome – a topic that his colleague Dr. Ian Lipkin is interested in investigating.
I have no doubt that the P2P Workshop will open with statements from Dr. Anderson and Dr. Murray that this is a significant demonstration of NIH’s commitment to ME/CFS patients and research. That is how these meetings always begin. And I would love to hope that the Workshop marks a new chapter of increased attention and funding for ME/CFS at NIH. But given the confusion among leadership in January 2014, I have some trouble believing this to be a realistic hope.
This whole email exchange started because of the news item claiming that NIH was falling behind in its commitment to ME/CFS. Dr. Murray basically says Hey Dr. Collins, it’s not true because we’re planning a meeting. And then for three hours, leadership muddles around trying to figure out what exactly the meeting is about and how it differs from the IOM contract. And the only thing Dr. Collins says is, I just hope you cover the microbiome.
It’s not just the confusion that bothers me, or even the narrow focus on one researcher’s interest in the microbiome. It’s the mindset reflected in that first email from Dr. Murray to Dr. Collins. It’s the bureaucratic mindset that responds to evidence of NIH’s failure to make any progress on a costly and disabling disease with “We’re having a meeting.”
The P2P Workshop represents an opportunity to get it right. It could address the problems that are holding ME/CFS research back. That may even be the intention of staff like Dr. Susan Maier, and it is certainly the intention of the ME/CFS expert members of the Working Group. But given the deeply flawed evidence review, the closed door selection of Panelists, the exclusion of many experts and important topics, and the inclusion of speakers who believe ME/CFS is a functional somatic syndrome, is it realistic to believe that the Workshop will start a new chapter and begin to make up for the stagnation of funding? What do you think?
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Jennie Spotila blogs on ME/CFS issues on OccupyCFS
An attorney before she came down with a severe case of ME/CFS in 1994, Jennie Spotila served on the Board of Directors of The CFIDS Association of America from 2006 to 2011, and as Chairman in 2008 and 2009. She has testified numerous times before the CFS Advisory Committee on CFS (CFSAC). Since 2012 she has been blogging on OccupyCFS on the politics of ME/CFS and other issues.
Jenny,
Thank you once again for your persistence and analysis of this troubling matter. I share your conclusions about the bureaucracy at NIH. God help us if Susan Meier is our best hope for any real action on this.
Chris Williams
These government agencies and their associated bureaucrats remind me of those in Charles Dickens’s “Little Dorrit”, with his Department of Circumlocution headed by the immovable Mr. Tite Barnacle, dedicated to the spirit of “How Not To Do It”. As the story’s protagonist searches for information, the government agencies never have anything conclusive to tell him since they only know how to talk around every point endlessly. The purpose of these agencies is to cling like barnacles to their lucrative jobs, accomplishing nothing, while they squelch all initiative or creativity on the part of the public, which they think exists solely to serve them and not the other way around.
I put my hope in efforts such as the Stanford project with Dr. Montoya and expect very little from the government, outside of delivering the mail.
Jenny,
Thanks so much for all the hard work, very enlightening. I think the saying ” the blind leading the blind” is both derogatory and too kind. I remember back in the early 80’s having an MD client who’s lover had AIDS and he worked with the CDC and flew back east every few months. He was just a regular doctor, but many of them took up in arms and forced the CDC and NIH to get on the ball! If only we had that kind of activism in our doctors!
It may have been talked about in the past but I would be interested in a post talking about why seperate definitions are needed for clinical use and for research. Is this the norm in other diseases like MS and Parkinson’s? It seems to me having two definitions only further muddies the waters. The only additonal definitions should be for subsets ME/CFS subsets.
Clinical use definitions are generally very inclusive. They produce a broad picture of the illness – all it’s symptoms – to help doctors recognize it when they seed. They tend to be fairly lengthy
My understanding is that research definitions are much more exclusive. They produce a narrow focus on the disorder. Their goal is to, as much as possible, ensure that only people with “X’ disorder and not others gets included in research studies.They’re looking to produce pure cohorts for study so researchers can really zero in on what’s going on that disease.
They will exclude some people who have the disorder(but have other confounding factors) or who are on the boundaries of having it.
Is the Gulf War Illness group fairing any better than we are? We don’t know! They don’t know! Nobody knows! Should we combine resources? Who knows?
Perhaps we should throw in with the M/S and Autism groups as well. The combined voices and resources could put us all over the top. No? Do we know if the common denominator is the same? RP
There is strength in unity, but everyone wants to lead so the dance will probably never happen.
The common denominator is greed and it exists at all levels.
At the lowest level is the worker who knows that if the problem (ME) is solved they will have to look for other work. To perpetuate the disease is to ensure their continued employment without having to worry about if or where they will be reassigned.
At higher levels greed is satisfied by overt payola in the form of high paying jobs in the private sector such as the deal that Gerberding got. There are also rumors of covert kickbacks from insurance companies that profit by not paying ME disability claims.
It is naive to think that the situation for ME / CFS will be better by the CDC, IOM, NIH and P2P. It is a political game. They don’ t want spend any money on this disease. There will only be a breakthrough when a good publication comes up which no one can ignore. Until then, nothing will change.
I agree that it will probably take some jaw dropping study (like XMRV) or some other action to produce a breakthrough in funding although we will see what they do with the P2P report.. I don’t see any reason to do that report if they weren’t going to back it up with a grant – but you never know.
The NIH is a particularly tough nut to crack..
But with that reasoning, what was the point of doing the 2011 State of the Knowledge Workshop without issuing a grant? (which they didn’t…)
Did they even follow the SOK Workshop up in any way?
I think things might have been different if Dennis Mangan was still there. And if there were “Dennis Mangans” in other pivotal positions at the NIH.
I worked for 16 years as a government employee at a Veterans hospital, I experienced this very phenomenon firsthand. It is the most unbelievable example of ineptitude you can imagine. If you look up “The Peter Principle” you might begin to understand. The higher the level of manager you encounter the worse the understanding they have of the job to be done. If you want the real scoop on anything you need to ask the lower level employees, it’s true and it’s sad. Jennie is spectacular in her ability to parse it all out for everyone to understand. She makes it into a comedy of errors. It’s why our tax dollars are ever increasing, we pay more and get less because of incompetence like this. It’s also why 30 or so years later CFS has barely made a dent in finding any remedy. Multiply this for all the sufferers of all diseases and you’ll see why America has a very bad healthcare system. It’s a tragedy. The good news is that the private sector has taken it on like never before and we have more involvement than ever and studies are churning out in spite of the lack of government ability to lead so I take heart in the ever increasing knowledge coming from the brains that have not been infected by the Peter Principle.
Personal note: My wife works at NIH and I was treated there for kidney cancer in 2009 and
have no re-occurrence since then.
Many thanks to Jennie Spotila for her in depth coverage of the flailing about of the Feds at NIH.
I think NIH will remain largely irrelevant in ME/CFS research as long as the disease remains within the purview of the Office of Research on Women’s Health buried in the Office of the Director. The OD is treating ME/CFS as a political issue not science. To be clear the ORWH has no direct involvement with research and exists to advise the Director and assist with coordination of research efforts.
As a man who is disabled by ME I do have an issue with defining ME/CFS as a women’s disease. I do not believe there is any reliable epidemiological data yet.
We will know that NIH is serious about the disease when it is reassigned to one of the research institutes where there is actually money allocated for research grants. ME/CFS should be in the National Institute of Allergy and Infectious Diseases, where CFS was placed prior to the creation of the ORWH. This probably will not happen until Dr. Anthony Fauchi is gone.
Despite the above, there is no reason to despair. I find there has been a big change in the attitude of the medical profession and general public regarding ME/CFS. Not much is yet know about effective treatments, but many more physicians recognize ME/CFS is a serious illness. Medical knowledge is expanding rapidly. Inevitably there will be discoveries that lead to effective treatments.
I am living my life to the fullest extent I can and accepting that I am Ill without regret. Life is too short to be hanging around hoping things will change due to forces that are beyond our control.
Especially, I am thankful that there are good people like Jennie Spotila and Cort Johnson who have the energy and judgement to keep track of what is going on and share their insights with us. You guys are amazing!
Here! Here!!!
Thanks to everyone for the kind words! I agree that we won’t get far without being assigned to an Institute that is willing to put money on the table.
So basically, after 30 years, we still have no leaders that are willing to step up to the plate and take research into this disorder seriously.
I think Pres. Obama should be made aware of these machinations. After all, he publicly said he would do something to improve the current situation
He said a lot of things. He has 99 things on his mind and we aren’t 1 of them.
Jennie, reading CJ’s note above it seems everyone has forgotten why ME is in ORWH. It is there because Antony Fauci petitioned Harold Varmus to put it there, as Hilary Johnson long ago documented. If Fauci had sincerely believed ME were “psychological” as he claimed, it would have gone to the National Institute of Mental Health. If people had followed the lead followed by the 1987 paper by Komaroff, Cheney Peterson et al that the disease has something to do with the immune system it might have gone in with Rheumatoid Arthritis in another National Institute.
As Hilary has pointed out, the ORWH is the “janitor’s closet” of the NIH. Anthony Fauci demanded that it be put in the “janitor’s closet, which was done with the help of Harold Varmus, then Director of NIH and now head of Sloane Kettering. “Until someone documents why Fauci wants it in the janitor’s closet nothing will make sense. It would also be interesting to find out why Varmus cooperated and why Collins cooperates when he knows better about the science.
The Feydau farce you outline has a reason for being. It serves someone’s purpose. What, who and why?