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Dennis Mangan was the chair of the Trans-NIH Working Group for ME/CFS, a little-known but critical element of the chronic fatigue syndrome program at the National Institutes of Health (NIH).  In this long interview done last year I asked him, a former insider, why it’s so been so difficult to get anything done at the NIH.

First Some History

connection to Institute lost

Upon leaving the NIAID a critical connection to a powerful Institute was lost

The National Institute of Allergy and Infectious Disorders (NIAID) housed chronic  fatigue syndrome since the mid-1980’s to around the year 2000.  While the NIAID never embraced ME/CFS it did create three ME/CFS research centers, and it was funding ME/CFS to the tune of about $7 million dollar a year.

Citing the fact that ME/CFS did not appear to be a infectious disease, and the multidisciplinary findings now characterizing the disorder, CFS was booted out of the NAIAD around 2000.  Into the small Office Of Research On Women’s Health (ORWH) under the Office of the Director (OD) it went.

The central managing center of the NIH, the OD sets policy for the NIH as a whole and is responsible for “planning, managing and coordinating” programs across the NIH.  In 2015, the Office of the Director will spend almost 1.1 billion dollars on research.

research chronic fatigue syndrome

Upon leaving the NIAID a new mechanism for funding research had to found for ME/CFS

The ORWH was created in 1990 to promote research into women’s health issues. One of the smallest Offices in the NIH, the ORWH’s budget is about 41 million dollars this year.

The NIAID had already dumped ME/CFS when Vivian Pinn, the director of the ORWH saw that it had no home. Realizing that women were mostly affected and not wanting ME/CFS to be cast adrift, she offered to give it a home.

She was given the part-time services of Eleanor Hanna and zero dollars to run the program. From then on ME/CFS would depend funds from either from the ORWH’s coffers or via a newly formed group called the Trans-NIH Working Group or Working Group.

Composed of representatives from a variety of Institutes the Working Group was tasked with supporting “ME/CFS research by providing NIH Centers, and Offices with evidence-based rationale for supporting ME/CFS research and for attracting investigators to study this complex illness”.   The rationale was that chronic fatigue syndrome was a multi-dimensional disease that didn’t fit in any one Institute. It would require the services of all the Institutes. The Working Group was an experiment in cross-Institute collaboration.

The Working Group, however, was given no budget either.  Instead, its members were given the unenviable task of enrolling the Institutes in funding a disease for which none of them had responsibility.

ORWH chronic fatigue syndrome

The ORWH was given no money to fund ME/CFS research or projects

Still, small contributions from the huge Institutes (NIAID – $4.4 billion, the NIMH – $1.5 billion, NIDDK – $1.7 billion and the NINDS- $1.6 billion – 2014) would make the program a success.  Three million dollars from five large Institutes and a couple of million more from smaller ones would support an expanded research program, Centers of Excellence, Conferences and other programs the disease needed.

Those contributions, however, never showed up. In fact, the opposite occurred.  The Institutes proved unwilling to support any ME/CFS projects that I can tell for next fifteen years. A long period of funding decline had begun.

The first casualties were the three CFS research centers. From 2001 to 2008 NIH funding dropped for ME/CFS by 45%.  The NIH went from funding almost 40 ME/CFS studies in 1999 to ten in 2009.

Adjusted for inflation by 2008 the NIH was spending as much on ME/CFS as it had been in 1989. Studies indicating that ME/CFS was not a niche disorder affecting yuppies but a common, often disabling disorder affecting a million or so people in the U.S. made not the slightest difference.

reduction funding chronic fatigue

The move to the ORWH and the creation of the Working Group began a long-term trend in declining funding

NIH funding for ME/CFS in 2015 is projected to be five million dollars – the same amount of money it was spending in 1993.

The reliance on the Working group to provide funding proved to be an unmitigated disorder for the ME/CFS community.

Before we get too upset at the Working Group, though, let’s look at the bind they were in. They’re asking their Institutes to give money to support a disease  for which they’re not responsible. The NAIAD’s funding is dependent on its ability to move the needle on hepatitis, HIV, and cancer – not ME/CFS.  NHLBI’s funding is dependent on making progress on heart and pulmonary disorders – not ME/CFS.

It was better to have ME/CFS in the ORWH than the alternative – having it be truly homeless – but it came with a price. ME/CFS was largely dependent on the goodwill of the Institutes for progress.

 The Dennis Mangan Interview

Dennis Mangan

Dennis Mangan, past Chair of the Working Group, worked at the NIH for decades.

Dennis Mangan is the former Chair of the Working Group.  He did a lot in his short time as chair. He added members to the Working Group, produced the State of the Knowledge Workshop, changed the name by which the NIH referred to ME/CFS,  created a Listserv and more.  He was open and embraced community input. He was breath of fresh air. He was frustrated, though, by his inability to move the bar on funding. After he left the NIH he served on the advisory boards of several ME/CFS organizations and participated in ME/CFS efforts.

I wanted to know how the NIH worked and what obstacles were getting in our way. First let’s start off with what Dennis was able to accomplish despite the obstacles he faced.

What could you as the head of the Trans-NIH group do on your own without prior approval?  I’m thinking of the Listserv, the changes to the website, using ME/CFS instead of CFS; things like that. Do you have to get approval for all that? Or did you just go ahead and do those things.

The Trans-NIH Working Group (WG) is under the direction of the ORWH.  I started monthly meetings with the members.  Representatives tell the Group what their Institute is doing, as well as help to increase awareness of CFS/ME at their Institute.

As the chair of the WG, I was a strong advocate for research on the disease, transparency at the NIH and communication with the public. This included setting up a listserv and a good website to inform the public of what was going on at the NIH.

After talking with attendees at CFSAC, I saw no reason to not include ME in the name.  My reasoning was that NIH supports and encourages research on the disease, regardless of what it’s called.  Call it whatever you want…but send in applications to study it and find a cure!

new directions

Dennis decided the name should be changed – and so he changed it…

At the time, I didn’t think that changing the WG name (to include ME) would be such a big thing at the NIH.  However, there was sizeable concern by NIH leadership that some sort of formal process should have been used to change the name of the Working Group.  I suspect that, had such a process been implemented, the WG name would still be CFS today!  As we’ve heard, “Sometimes it’s better to ask for forgiveness than to ask for permission.”

My decision remains unchanged: changing the name of the WG was the right thing to do.

I’d like to know how big things get done at the NIH; how a major project like the State of the Knowledge (SOK) Workshop (or the IOM contract) gets decided and then approved?  

Ideas for an SOK Workshop arose from input from both outside and inside the NIH.  For example, the SOK stemmed from numerous discussions with scientists, clinicians, and patients.  Evaluation of published research articles and ongoing grant projects provided concrete evidence of gap areas in our knowledge of ME/CFS.

An RFA usually targets a specific topic and has set-aside funds to support applications.  A PA is typically broader in scope and encourages applications within that scope, but has no set-aside funds.

The process for getting an RFA or PA approved follow similar paths.  Discussions with research and patient communities usually spark the funding initiative.  A Program Official submits a request for the RFA/PA and requests a funding level needed to support a few grants that will study the topic.

The Institute’s leadership evaluates the request and sets a putative funding level.  The initiative “concept” is then presented to the Institute’s Council (sort of like a Board of Directors) for their approval.  If approved by the Council, the RFA/PA is prepared and distributed to all Institutes at the NIH.  (By doing this, NIH avoids issuing overlapping or conflicting RFAs/PAs and allows other Institutes to sign-on.)  Finally, the NIH Director’s Office and the Center for Scientific Review approve the RFA/PA to make sure it meets all required regulations.

I suspect the process for approval of the IOM contract by the DHHS was similar to that for the NIH SOK workshop or setting up an RFA/PA.

Who decides you’re going to take on something like an RFA and the Workshop? Do you need to take it to the Trans-NIH Working group? Who do you need to get approval from? 

Workshops such as the April 2011 SOK are the result of extensive discussion and evaluation of the current situation.

The SOK was perceived as being long overdue and had urgency.  Its value to helping advance the field was considered great. That gave the workshop more visibility and higher priority.  I was assigned the Working Group chair position in mid-2010, we started serious conversations in Fall 2010 and then the SOK was held in April 2011.

ORWH and chronic fatigue syndrome

The tiny ORWH may be the only Office or Institute in the NIH to fund any ME/CFS projects in the past 15 years.

The Office of the NIH Director was fully in support of the SOK.  The ORWH (one of many offices within the Office of the Director) did not hesitate to take on the responsibility of hosting and paying for the SOK.  To keep costs down, the conference had to be held on campus and not in a hotel conference room.  Because of the nature of the SOK in which the 30+ participants would discuss and debate issues, the conference room was needed that provided an environment that encouraged interactions.

ORWH funds were eventually allotted for video recording of both days.  Getting space on campus and setting up the video required assistance of many teams at the NIH.  With campus security tight since 2001, we also had to work with the NIH police department.

In short, the SOK required the cooperation of many parts of the NIH as well as other Federal agencies within the DHHS.

You noted that the “Office of the NIH Director was fully in support” of the SOK, but that funding of the SOK still came solely from the OWRH’s small budget.  Three funding sources are available to ME/CFS at the NIH: the Institutes that make up the Working Group, the Office of the Director and the ORWH itself. Of those, it appears that only the ORWH, with its miniscule budget, has put forward significant funds for ME/CFS projects. Would you say that that’s accurate? 

ORWH (one of the many offices within the Office of the Director) stepped up and did the right thing by supporting all aspects of the conference.  ORWH recognized the importance and urgency of a meeting to summarize research on this illness.   The costs of the conference greatly strained their tiny budget.

The Trans-NIH Working Group for ME/CFS

“No IC (Institute or Center) wanted to give ME/CFS a home.  The result: no RFA and no COE.” Dennis Mangan

Given that the broad agreement on the State of Knowledge Workshop can we assume from that that the Working Group has not been in agreement on the need for an RFA or Center of Excellence – two major objectives that both CFSAC and advocates had pursued for years?

The Working Group considered many ways to increase funding for CFS/ME.  This included sponsoring an SOK workshop, setting up a useful website, and spreading information about CFS/ME to potential applicants.  Although the SOK provided the WG with lots of useful information and help to elevate awareness of CFS/ME, no Institute stepped forwarded to support an RFA.

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Every effort to increase funding or support for the ME/CFS community appears to have been rebuffed by the Working Group

If you put the budgets of the Institutes that make up the Working Group together, you’re looking at billions of dollars of research funding a year. That seems like a nice pool of money to draw from –easily enough one would think to get a couple of COE’s built. The advocates have tried.  They’ve highlighted the need for knowledgeable providers and for rigorous research to identify suitable treatments – something COE’s could provide. Here’s a list of CFSAC recommendations for COE’s from 2004-2010

  • 2004 – asks five regional Centers of Excellence; 1.5 million/year per COE
  • 2005 – asks five regional Centers of Excellence; 1.5 million/year per COE
  • 2007 – asks for five regional Centers of Excellence; 1.5 million/year per COE. Produces a document explaining why COE’s needed, notes complete lack of clinical/research centers, notes high economic costs to nation, the need to treat and identify treatments rigorously  and in an organized manner and get them out to other physicians
  • 2009 – asked twice for five regional Centers of Excellence; 1.5 million/year per COE
  • 2010 – in lieu of asking for COE’s, asks government to fund networking between clinics and develop a national clinical and research network.

Let’s take just three Centers of Excellence for ME/CFS funded for $1.5 million/each ($6 million/year).  Thirteen Institutes and several Offices are represented in the Working Group.  If they split that amount evenly each would pay a little over $400,000/year –  a very small for medical research – yet even this is too much. Massive needs have been documented by federal studies for ME/CFS and the governments federal appointees have asked for COE’s again and again,  – yet they still won’t do it. Why?

working group says no

The small State of the Knowledge Workshop was funded entirely by the ORWH.

I like how you broke down the numbers and showed how funding could be divided among the WG participating Institutes.   However, just because an IC is a member of the WG doesn’t mean it recognizes the importance and urgency for a COE.

Most of the major Institutes such as NIAID are still reluctant to give ME/CFS a “home.”  Thus, it is hard to get anyone at NIH to advocate for RFAs and COEs.  In short, ME/CFS needs a “home”!  Right now, the best fit for a home IC would seemingly be “neurology”, such as NINDS.

You stated “We also knew that recommendations from a Workshop would give credibility and substance to a request for funding for ME/CFS research via an RFA or PA.  An RFA followed the Neuroimmune Workshop in 2003.  I expected one to follow the SOK workshop. I thought that Workshop was done in order to prepare for an RFA. Did you expect an RFA would follow the Workshop?  Do you know why one did not follow?

I wanted the SOK information to guide us as to how to move forward with funding.   There’s many research areas related to ME/CFS that could benefit from an RFA (or COE), such as immunology and neurology.   However, NIH as a whole grew very conservative in 2011, and no IC wanted to give ME/CFS a home.  The result: no RFA and no COE.

ME/CFS - homeless at the NIH

Mangan asserts fundamental change – a move to an Institute – is needed before the ME/CFS field will move forward

In theory, it makes sense for a range of Institutes to fund research into the range of problems found in ME/CFS. The core responsibilities of the Institutes, however, lie elsewhere. It’s not clear, for instance, why the Heart, Lung and Blood Institute with its hands full of heart disease would be interested in funding ME/CFS research.

Plus the buck doesn’t stop anywhere with the Working Group. Since this is a group effort no one Institute will ever shoulder the blame for not solving ME/CFS or get the credit for solving it. One can make the case that this funding structure has doomed ME/CFS to poor funding.  What are your thoughts on this?

Quite simply, I would like to see one of the major Institutes at NIH give ME/CFS a “home.”  Even if they are reluctant to support research on ME/CFS, these studies will likely elevate our understanding of other diseases and conditions, such as viral infectious diseases, autoimmunity, neuroinflammation, and so forth.

Politics

Various suggestions, including congressional action and Dr. Collins stepping in have been put forth for solving the funding dilemma. I explored these in the Politics section.

weapon

Getting Congress to force the NIH to fund ME/CFS is a possibility – but a short-term one unless the underlying factors that have kept it stuck are addressed.

Both Ian Lipkin and Llewelyn King have asserted that the only way Chronic Fatigue Syndrome is going to get significant funding from the NIH is for members of the Congress to demand it. That’s how both breast cancer research and autism – two other disorders the NIH was initially reluctant to fund – got their funding going. What are your thoughts on this? Is it going to take Congresspersons demanding more funding for the NIH to start pumping substantial amounts of money into ME/CFS?

I don’t like politics becoming the determining factor in scientific research. However, this might be necessary for increased funding for ME/CFS.

Do you ever interact with Senators or Congressmen? 

Not directly.  However, letters from Congress were delivered to me after going through the usual channels in the Office of the NIH Director and then the Director of ORWH.  My job was to draft a response to their queries, explaining how NIH was addressing particular issues, such as the need for Centers of Excellence or funding for specific research centers.  These letters again helped us recognize the urgency for an SOK.

Some suggestions have been made that we target Director Collins. Ian Lipkin has said NIH Director Collins recognizes that ME/CFS is ‘a problem’ and he would love to have money to devote to it, but his hands are tied.  I talked to a researcher who said the NIH director could force the Institutes to do something, but he/she would pay a price. That made sense; the Institutes are the experts in their respective fields and having the Director telling them how to spend their money would probably not go over well.  Do you ever see the Director telling Institutes to devote more money to certain areas and if so what prompts that?

It’s no secret that Dr. Collins is a big supporter of genetics research.  However, I’ve never seen him dictate that any IC fund genetics over some other area.  What the Director’s office can do is show Institutes how research on ME/CFS can provide insight into the pathophysiology of many other diseases and conditions.  That is what ORWH tried to do in 2011.

Ian Lipkin recently also said the Anthony Fauci, the head of the NIAID would like to fund ME/CFS research but his hands are tied.  But if Fauci wanted to spend money on an ME/CFS RFA, for instance, wouldn’t he just tell his Trans-NIH representative that the NIAID is willing to pump some money into that? How can the director of the NAIAD have so little power?

My understanding is NIAID is eager to support grants … just not through the RFA (money set-aside) mechanism.

(Because they come with guaranteed funding researchers flock to RFA’s  That makes them a prime need for an ME/CFS field that has received little investigator interest. The NIH recognizes this. They have consistently bemoaned the lack of grant applications for ME/CFS, and have consistently stated they would fund good grants if they would only get them. Dennis notes that NIAID says they’ll pay for studies yet they have refused to fund the one mechanism – an RFA – guaranteed to bring new grant proposals and new investigators into the field.

The more cynical among us might suspect that the NIAID doesn’t want to grow the field. They know RFA’s would bring in new investigators and that would lead to more grant applications and require them to fund more ME/CFS grants. Jennie Spotila’s analyses show the ME/CFS field has been situated among the bottom dwellers at the NIH for decades. (It’s 233rd in funding.)  It’s not moving forward or backwards at this point and that’s not likely to change. The NIAID and every Institute on the Working Group knows this.

The one RFA in ME/CFS’s history – the Neuroimmune RFA of 2006, did what it was supposed to do. It attracted increased numbers of grant proposals and added new researchers to the field. )

What about the Director of the DHHS? Does he/she ever reach down and tell the Institutes what to spend their money on?

Not that I know of.   Just below the Secretary of DHHS, Dr. Howard Koh and Dr. Wanda Jones gave ME/CFS high visibility within the Department, but did not dictate to agencies how to spend their appropriations from Congress.

ME/CFS must move to an Institute

ME/CFS is going to have to move to ever get the funds it needs..

If I’ve heard you right, until an Institute steps up to give ME/CFS a home you don’t see the Trans-NIH Working Group working together to fund RFA’s, COE’s or any other major projects for Chronic Fatigue Syndrome? Would you say that’s correct based on your experience there? 

To clarify, although the WG elevates awareness for ME/CFS across the NIH, it has no funding authority.  Institutes have funding authority …that’s where the money for an RFA or COE originates.

That is why it is important for an Institute at NIH to take ME/CFS as part of its mission.

Conclusion

“Thus, it is hard to get anyone at NIH to advocate for RFAs and COEs.  In short, ME/CFS needs a “home”!” Dennis Mangan

There you have it. If anyone knows what this disease needs Dennis Mangan does.

Barring some unusual development such as the Office of the Director directly funding ME/CFS, until an Institute “owns’ and is responsible for ME/CFS, it’s very hard to see how opportunities that the P2P and IOM reports present are ever going to be fulfilled.

It's time to go....

It’s time to go….

Even if the Working Group stepped up for the first time in its history and supported this disorder this year, it’s history suggests it’s commitment would quickly fade.  A similar situation might occur with a Congressional Directive.

The ORWH – which took ME/CFS in after it had been cast adrift by the NIAID – is the hidden hero in all this, but without set-aside funding for the ME/CFS program coming from the OD, it’s been simply too small to provide for ME/CFS’s needs.

It’s time to push for fundamental change – a rethinking of every aspect of  this program  – where it is located,  how it is funded, how it will move forward. In  short how it can thrive.

The past fifteen years suggest that until ME/CFS gets “advocate” – an Institute – to back it – the next fifteen years are going to look like the past. It simply has no source of funding to draw from.

That’s why the first recommendation from the P2P draft report shouldn’t have been to increase funding but to give ME/CFS a home in an Institute and make an Institute responsible for it. The buck has to stop somewhere finally.  Moving to an Institute doesn’t mean chronic fatigue syndromes troubles are over, but it does mean it may have a fighting chance. It doesn’t now.

That should have been clear 15 years ago.

If the million or more people with the U.S. are to get relief and support, the ME/CFS program must move.

  • Next Up -The Institute We Should Move to – and Why Fibromyalgia Should Move With Us

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