NIH ME/CFS Advocacy Call - April 2019

Coordinator:  Welcome and thank you for standing by.  At this time all participant lines are in a listen only mode.  After today’s presentation you will have the opportunity to ask questions.  And to do so at that time you may press Star 1 on your phone’s keypad.  Today’s conference call is being recorded.  If you have any objections to this, please disconnect at this time.  And now I would like to turn the call over to your host for today Ms. Margo Warren you may begin.

Margo Warren: Thank you.  Good afternoon everybody.  My name is Margo Warren and I’m from the Office of Communications and Public Liaison at the National Institute of Neurological Disorders and Stroke.  On behalf on NIH I’d like to welcome you to this afternoon’s teleconference.  And thank you for participating in this discussion today.  Dr. Walter Koroshetz, the Director of NINDS, will introduce the speakers.  Each of them will make some remarks after which time we will open the phone call for your question.  We’ll try to make our remarks brief so that we can answer as many questions as possible in the remaining time.  And we also ask that you limit yourself to one question each if you could so that we can hear from as many of you as possible.  So now, here is Dr. Koroshetz.

Dr. Walter Koroshetz: Good afternoon and welcome to the first briefing of 2019.  Since our last call there has been a number of developments at NIH related to ME/CFS and we’re excited to update you on what we have been doing.  We have a number of items on the agenda for today.  Dr. Nath will update us about the intramural study going on here in the Bethesda Campus.  Drs. Vicky Whittemore, Joe Breen, and Andrew Breeden will describe the latest activity from the Collaborative Research Centers,  as well as the NINDS Council Working Group for ME/CFS Research.  We will also provide an overview of the meeting we held last week for young investigators and early stage investigators interested in working in the ME/CFS field.  And then we are very delighted to be joined by Dr. Tony Komaroff from Harvard Medical School and he has been invited to give us a summary of last week’s conference called “Accelerating Research on ME/CFS” that was held here at the NIH.

You will hear more about the Council Working Group in a few minutes but I wanted to remind everyone that there is a Request for Information currently out.  And it is soliciting input on how best to advance ME/CFS research.  We’d very much like to hear your suggestions on how to best move this field forward.  The deadline for responses has been extended to May 1st and you can access the RFI by going to the NIH’s ME/CFS website which is  We want to remind everyone while we’re talking to you here from NINDS, ME/CFS research at NIH is a trans-NIH effort and many, many Institutes are involved.  We are eager to hear from you so we will keep our own remarks very brief before opening the lines for your questions.  With that, I’d like to turn the call off to Dr. Avi Nath, our Clinical Director at NINDS, and talk to you about the ME/CFS program going on in the Clinical Center at NIH. Avi?

Dr. Avindra Nath: Hi.  And so it’s a pleasure to have the opportunity to talk to you and to update you on the intramural program.  So, you know, last week we had the conference.  And unfortunately, I wasn’t able to attend due to a family emergency.  But, Brian Walitt who is the Lead Investigator on our study, made a presentation and provided an update on where we stand.  So, the feedback I received is that it was well received.  And that we’ve made actually tremendous progress.  So we are now at the mid-point for recruitment.  And so at this point we are going to do an interim analysis and try to see what’s gone well and what hasn’t.  And we look at all the testing that we’ve done so far.  Because we decided to do a very exhaustive testing on all these patients.  So the question really is,  what is it yielding.  And if there is time now to retool ourselves.  And so, that’s how we are proceeding right now.

And, you know, as Brian presented we have a very rigorous screening process.  A lot of patients that initially come to us with the diagnosis don’t quite turn out to be the case.  And so we’ve found a lot of alternative explanations for their symptoms.  And I think in a way that also advances the field.  Because in some ways ME/CFS may be a compendium of various diseases there. And I think trying to sort that out, also it could be very helpful to the community.  So, that’s basically all that I have to say at the moment.

Dr. Walter Koroshetz:  Okay, well thanks Avi.  Now I want, we could turn to Dr. Komaroff to talk to us a little bit about, Tony will you be available to talk a little bit about the overview?

Dr. Tony Komaroff:  Sure, right now?

Dr. Walter Koroshetz:  Yes, that would be good.

Dr. Tony Komaroff:  I’d be happy to.  Well it was an exciting conference for many of us.  It was a forum for presenting the latest research on the biology of the disease.  It was a three-day conference including the day for young investigators that you just heard about.  As I understand it, there were close to 1,000 participants, including those who were viewing it online.  And there were roughly 30 different scientific presentations by scientists from many different countries.  For those of us who have been around the field for a number of years,  it was especially gratifying to see some presentations made by scientists who were brand new to the study of ME/CFS,  including one of the world’s most honored geneticists and one of the world’s most honored immunologists.  But even more exciting than these, you know, seeing these senior world class scientists involved was the interest of the young scientists.  They presented their work, they discussed with NIH staff the nitty-gritty details of how to build a career that involves studying ME/CFS.

So those of us who have been involved in caring for patients with the illness and studying the illness for a long time,  I think found two things impressive.  One, how far we’ve come in the last 30 years and the second, how far we still have to go.  It was 30 years ago that the illness got a name although, probably the illness has been out there and described in the medical literature even before that.  And it as everyone knows was controversial particularly at the beginning because it was defined by symptoms.  And anyone can say they have a symptom.  So in an illness defined by subjective symptoms doctors and scientists naturally ask are there any objective underlying abnormalities in people with the illness,  the things you can measure with various kinds of tasks.  And 30 years ago the answer was no.  But since then, there have been over 9,000 scientific published reports comparing people with ME/CFS to healthy people.  And in some cases to people with other diseases that can cause fatigue.  And as it’s true in any field some of these reports have not been confirmed by other scientists.  But very many of them have been confirmed.  And, many of the presentations at the conference confirmed or extended what had previously been reported.

So specifically the work at the conference and prior research demonstrates that in people with ME/CFS there are various abnormalities.  Abnormalities involving the brain and the autonomic nervous system, which is the part of the nervous system that controls things like blood pressure, heart rate, breathing rate. Abnormalities in metabolism particularly, the body’s ability to produce energy molecules, like ATP.  Abnormalities in the immune system, which appears to be engaged in the chronic battle against something.  Abnormalities in how certain genes are built and abnormalities in whether genes are turned on or turned off appropriately.  And then finally, abnormalities in the microbiota,  the microbes that live on and inside all of us and I’ll come back to that in a minute.

So, why spend so much time and effort on finding these objective biological abnormalities in people with ME/CFS?  Because that is what you need to do in order to develop a good diagnostic test and effective treatments.  And there is another reason too.  When a person tells you they have symptoms they and you can’t prove it.  But measurable, objective, biological abnormalities, you can’t make that stuff up.  It says there is a real, biologically based illness here.  Here were just a few, I mean it’s not possible to summarize all of the presentations.  But a few of those that I thought were particularly interesting.  And a number of past studies have found evidence of inflammation in the brain, inflammation means activation of the immune system.  A new report at the conference confirmed that finding using much more sensitive and accurate technology called MR Spectroscopy.  They confirmed what others have previously reported is that there is an increase in several molecules in the brain including lactate.  And they also reported a novel finding that I haven’t seen before.  Which is their technology allowed them to measure the temperature of different parts of the brain.  And they found that in people with ME/CFS, there are many areas of the brain that are just hotter than those same areas in healthy people.

Another study from Sweden measured molecules present in the spinal fluid that bathes the brain.  That’s a way of estimating, by measuring things in the spinal fluid it’s a way of estimating what is happening in the brain itself.  And they found increased levels of molecules that signal inflammation of the brain and that signal damage to cells in the brain.  And attempts to repair that damage by the body’s immune system.  Another study at the conference pursued the question of why people with ME/CFS feel fatigue and brain fog when they remain standing for a while.  It found that blood flow to the brain starts dropping after people assume an upright posture.  It does so fairly promptly and continues to do so as they remain upright.  Another presentation summarized what research has shown about energy metabolism in people with ME/CFS.  The levels of most metabolites are lower in people with ME/CFS.  A similar pattern as you see in animals that hibernate and I’ll come back to that in a minute.  And the other thing is they describe the variety of ways in which the body is unable to make enough energy molecules from oxygen, from sugars, from fats and the amino acids.  The four sources of energy in all of us.  Another presentation showed how theoretically information about the levels of different molecules in the blood can be merged with knowledge of different drug actions to identify drugs that theoretically might offer relief of symptoms in people with ME/CFS.  Another study reported on a blood test called an impedance measurement that was abnormal in every single severely ill person with ME/CFS.  And then absolutely no healthy control subjects, a report that soon will be published in the Proceedings of the National Academy of Sciences.

Several presentations reported on the marked differences in people with ME/CFS when they perform an exercise stress test.  Particularly when the stress test is repeated 24 hours after the first one,  people with ME/CFS have lower heart rates, lower blood pressure, lower breathing rates.  And they also don’t extract oxygen from the blood as effectively as healthy people.  And so their cells don’t get all the oxygen that they need.  More important in these individual presentations about abnormalities in particular systems,  the presentations also provided some clues about what might tie all of these abnormalities together.  For example, is there a connection between the body’s inability to produce enough energy molecules  and the abnormalities that have been found in the brain?

So, what theories were presented that might tie together all or most of the biological abnormalities that have been reported?  Presentations supported an attractive theory that ME/CFS may be the result of a biologically ancient mechanism that is meant to protect us from temporary injury or illness.  A mechanism called a sickness behavior, what is that?  Well, when we become sick, like, when we get the flu, what happens?  We don’t feel like doing much, we ache, we want to sleep, we don’t have much appetite. Why is that?  That’s an ancient protective response that is hard-wired into our brains, sickness behavior.  What value does it have?  It causes us to cut down on activities that require energy.  Thereby giving us more energy to fight off the illness.  What causes the fatigue when we’re sick?  Several people speculated and I think it’s likely that somewhere in the brain there is probably a small group of cells.  A fatigue nucleus you could call it, that creates the sensation of fatigue.  The cells in that fatigue nucleus can be triggered by activation of the immune system in the brain.  Probably by other things as well.

So what activates the immune system in the brain?  Not surprisingly inflammation inside the brain, like, an infection could do it.  But more important over the last 20 years, particularly it’s become clear that inflammation outside the brain elsewhere in the body can activate inflammation inside the brain.  And one candidate that through various mechanisms that were presented at the conference.  One candidate for causing inflammation in the body but outside the brain was inflammation in the gut caused by the genes of the microbes that live in our gut called our microbiome.  Various presentations at the conference were in line with this concept.  Now, recent research the reason people are so interested in the microbiome and that it may indeed play a role in a lot of disease is that in the last 10, 15 years we’ve revealed some astonishing facts.  The microbes that live on and inside us have more than 100 times as many genes as human genes.  And more importantly, these microbial genes can make molecules that affect human health, that affect human physiology.

So, in summary we heard some exciting new science at the conference.  Science that reaffirmed and expanded past scientific reports.  And the conference began to outline the model for understanding the disease.  The model still needs to be proved.  We also saw the result of powerful new research technologies that are available today but that were just a pipe dream 30 years ago when a lot of us were starting to study this illness.  For example new ways of imaging the brain, new ways of measuring thousands of molecules in the same sample of blood simultaneously.  New ways of rapidly sequencing genes, of determining which genes are turned on, and which turned off.  Really all of these were just a pipe dream 30 years ago.  But today they’re real because of research.  So, we also heard at the conference from Dr. Koroshetz and from Dr. Francis Collins, the director of the NIH, about their commitment to finding solutions for people with ME/CFS.  So, you know, don’t misunderstand me.  I’m not saying everything has been figured out, that we understand the biology of the illness, that there’s a cure in plain sight.  Not at all. I wish I were but, I’m not.  We still have a long way to go to get fundamental answers in this disease as in others.  But the conference highlighted the progress that has been made over the past 30 years.  And at least in me with the new technologies I’ve mentioned, with continued support from the NIH, and with efforts to attract more new scientists into the field, old and young,  I think the day will come when there are fundamental solutions for this terrible illness.  So I left the NIH conference excited and encouraged.

Dr. Walter Koroshetz:  Thank you very much Tony for that excellent summary.  As you mentioned, lots of clues now to follow-up.  So, let me move to our next topic and that is Vicky Whittemore, Joe Breen, and Andrew Breeden talking to us about the latest activities of the ME/CFS Collaborative Research Centers.  And then also they’ll go in and tell us about what the Council Working Group for ME/CFS research is at this stage, where they are at this stage, great.

Dr. Vicky Whittemore:   Thank you, Dr. Koroshetz and good afternoon everyone.  So, to give you a quick update on the Centers research.  At the conference last week we had several of the young investigators who attended the young investigator workshop and presented their work.  As well as at the conference there were two investigators from the each of the Centers who presented their data.  And its, I think, very exciting first of all that they are moving forward with research and are reporting out their preliminary findings.  There’s a collaborative project that there was reported out on that is a collaboration between the Centers.  And I think they’re really beginning to uncover some very interesting aspects of the disease.  That, and as Dr. Komaroff pointed out, that our those either new findings or replicating findings from other investigators that will really help to move the research forward and help really, I think narrow down our search for what are the causes of ME/CFS and what can we then identify as targets that will help us to better treat ME/CFS.

So last week at the conference we also had representatives from the Data Coordinating Center who attended.  And I think that was very helpful for them to see the scope of the research that is ongoing not only in the Centers but overall in the research field.  To just give you a little more information about the collaborative project.  What is being done is that in a previous grant Dr. Ian Lipkin was able to collect biospecimens from a cohort of individuals or from a number of individuals with ME/CFS who are also carefully characterized with their clinical symptoms.  And those samples were then shared across the three Centers.  And Dr. Hanson is doing some research looking at mitochondrial function and exosome function.  Really trying to understand some of the basic,  what may be some of the basic dysfunctions going on in the underlying systems in individuals with ME/CFS.  Dr. Unutmaz at Jackson Labs is looking at changes in the immune system.  And Dr. Lipkin is looking changes in epigenetics, or ways in which genes are regulated in individuals with ME/CFS.  And the key to the study is that they’re all doing different experiments, but utilizing the same biospecimens.  So that they’ll be able to come back together to really look at changes that are occurring in an individual, in each individual with ME/CFS in the study across these different systems.  So they’re in the process of analyzing that data now and so, we’re hoping that very soon we’ll see some of the highlights and results of those studies.  So, at this point I will pass it onto Dr. Breeden who will talk to you about the ongoing activities for the NINDS Working Group of Council, Andrew?

Dr. Andrew Breeden:  Thanks Dr. Whittemore.  So, first just to give a little background about what the Advisory Council is.  So each NIH Institute or Center has a National Advisory Council that is made up of scientific and medical experts who can advise the institute director, in this case it would be Dr. Koroshetz, on important policies and procedures.  And so, in the summer of 2018, NINDS formed a working group of our Advisory Council called the National Advisory Neurological Disorders and Stroke Council.  And this working group is focused on how to best advance ME/CFS Research.  The working group is composed of scientists, clinicians, representatives from advocacy organizations, and individuals with ME/CFS.  If anyone is interested, the full working group roster is posted on the NINDS website.  And we’re very fortunate to have Dr. Komaroff on the call today who is a member of this working group.

So in short, the working group is charged with three main things.  The first is to identify gaps and opportunities in ME/CFS research.  And suggest strategies for overcoming these, the gaps and opportunities, and to capitalize on opportunities.  To examine how to attract and train a pipeline of new and early career ME/CFS Investigators, which we think will be really critical for growing the field.  And moving forward, to examine how to enhance ongoing research collaboration and communication.  So far, the working group has held conference calls on a regular basis.  And held an in-person meeting in December of 2018.  And at this meeting it was decided that given the diverse activities in the working group’s charge that five sub groups should be formed to make a concerted effort across the different topics that the working group is examining.  And this includes things like how to gather stakeholder input, how to increase ongoing collaboration, how to develop the workforce, and to examine gaps and opportunities,  both in research into the pathobiology of ME/CFS and in clinical ME/CFS research.

And as Dr. Koroshetz mentioned, the working group thought it’d be really important to gather wider stakeholder input into this process.  And so, there is a Request for Information that is open until May 1st.  At the beginning of the call Dr. Koroshetz mentioned where that is available if anyone is interested in providing input into this process.  And so over the coming months, the working group will continue to have extensive discussions about how to best advance ME/CFS research.  And then we’ll produce a report that will be presented to the NINDS Council in September and this report will also be made public.  And so we will continue to keep you updated on progress as the working group continues its work and thanks again Dr. Komaroff for being a part of this group.

Dr. Walter Koroshetz:  And I would just like to emphasize that this report will be shared among all the institutes that are participating in the Trans-NIH Working Group for ME/CFS research.  We did have to pick one Council to go through and so we picked the NINDS Council.  But this is going to inform NIH in general and clearly, you know, the leadership from Dr. Fauci and Dr. Joe Breen have been essential in moving to where we are now.  And Joe, is I know on the phone and was one of the major coordinators for the recent “Accelerating Research in ME/CFS.”  And Joe, I wonder if you could tell the folks a little bit about the conference,  particularly the young investigators workshop that occurred the day before the conference, the two-day conference.  Joe, can you hear us alright?

Dr. Joe Breen:  Yes.

Dr. Walter Koroshetz:  And would you be able to talk folks about that?

Dr. Joe Breen:  Sure.  I just wanted to say a word about the accelerating research conference that Dr. Komaroff already did an excellent job of summarizing some important aspects that were covered.  But I just wanted to back up a second and let people know that there was a group of dedicated folks from across the country actually in a number of research and advocacy organizations as well as patients who helped put together the program for this meeting at NIH.  And I think it did exactly what Dr. Komaroff described, it didn’t do everything but we think we covered a lot of science and I think we saw a lot of progress in terms of understanding the biology associated with ME/CFS.  And there’s been lots of positive feedback and I just want to make sure that the efforts of the group of people that were on the organizing committee is noted because it was a diverse group and I think the conference was much better for it.

With regard to the young investigators workshop there was some overlap with the conference. So the young investigators workshop was Wednesday, April 3rd and the accelerating workshop was -- or the accelerating research was April 4th and 5th.  And the posters from I think about 15 of the young investigators were displayed at the larger workshop on the first evening.  And there was a lot of excitement looking at the science that was brought out from those young investigators.  And I think it gave them a chance to network with established people from the largely attended conference,  which as Dr. Komaroff noted we had about roughly 300 people had registered.  We had more that registered but there was some that simply couldn’t come and we understand that.  But there were upwards of 600 some people online at the conference.  So it really we had quite a bit of bandwidth.  And I also should mention that the entire conference,  with the exception of the posters, was videocast and archived and is available for viewing.

So the young investigators workshop actually, Dr. Koroshetz, was greatly due to the work of Drs. Breeden and Whittemore.  And I think it was such a great workshop and I think gave an opportunity for our young investigators that I think it would be appropriate if Dr. Whittemore could describe that a little bit because she really played a major role in organizing that workshop that happened last Wednesday.

Dr. Vicky Whittemore:   Thank you Dr. Breen.  Yes, it was so this was the first young investigator workshop here in the United States, but it was really modeled after the first one that was held in conjunction with the Invest in ME conference in the UK last year.  So, Richard Simpson who heads up Invest in ME kindly let us copy his model and we had about 40 young investigators that came.  And we were able to support 26 of those young investigators with travel awards.  And then the additional 30 individuals were either NIH Staff or more established, more senior investigators who came to the workshop. It really was I think a terrific day where we talked about the logistics of building a career in ME/CFS, how to apply for grant funding to NIH,  and then in the afternoon the young investigators themselves presented some outstanding and very rigorous and exciting research to the group.  And as Joe said several of them then also presented posters at the larger conference.  So this is just the beginning of building a network and this is also part of Richard Simpson’s plan that we’re working with him  to develop a worldwide network of young investigators who can really work together, support each other, network and help each other through the process of moving through their careers doing research in ME/CFS.  So Andrew, did you want to make any comments?

Dr. Andrew Breeden:  No, I think that was an excellent summary and we were very pleased with the turnout and felt that there was a lot of positive interactions and networking that will hopefully continue into the future.

Dr. Walter Koroshetz:  All right.  Well thanks very much and I just wanted to tell folks that the conference, the “Accelerating Research in ME/CFS” conference is available for people to view.  We’ll send out the link to our list serv after this event.  But basically, you can go to and just see on the left for Past Events.  And you’ll find the ME/CFS Conference.  So you can - it was a two-day conference and was quite exhausting for a lot of folks.  But this is a way to see pieces of it a piece at a time.  And that should be there permanently for people to view.  So thanks very much everyone for giving their updates.  Thank you, Tony, for your summary and now I think we can open up the lines for questions.

Coordinator:   Thank you, sir.  If you would like to ask a question over the phone at this time, please press star then 1 on your phone’s keypad.  Please unmute your phone and record your name at the prompt.  If at any time your question has been answered you can remove your question by pressing star, then 2.  Once again please press star 1 if you would like to ask a question at this time.  Please stand by for our first question.  One moment please.  All right, our first question will come from Claudia Clarara, your line is opened.

Claudia Clarara: Hi, am I unmuted?

Dr. Walter Koroshetz:  Yes, we can hear you fine, yes?

Claudia Clarara:  Okay, great.  So I have one question.  But this is my first opportunity to speak to NIH officers so I have a few things to say en route to my question.  So, during the conference and today I heard from NIH staff that ME/CFS is a priority, that we are a family, and that this conference marks a turning point in research.  But my understanding is that the NIH has refused to commit the kind of resources, leadership, and focus that this public health crisis  requires.  And I mean it’s clear to me that those of you involved on the conference and in the working group are working on this very hard and the conference was great.  But to move forward, the existing structure of the NIH for promoting this research is just not working.  And the slow sort of wait and see plan of, like, well, what will come up in the intramural study.  That is unacceptable and I mean maybe if this disease was new, maybe if it was cropping up in a few dozen people at a time, that would be appropriate.  But this has been going on for decades.  And over those decades research has been actively stymied by the NIH.  So and, and at this point researchers don’t trust in the traditional, don’t have trust in the traditional granting process.  So the NIH really created this mess of how far behind we are with this illness.  And so, the NIH needs to solve it.

I see two major needs.  I think there is a fundamental need for a full office of NIH staff members who are devoted to advancing ME/CFS research both intramurally and extramurally.  I know all of you are working hard but it’s clear from your positions that ME/CFS is not the first and only priority for any one of you.  And that is not acceptable if this is going to be a real priority for the NIH.  I mean Joseph Breen during the conference towards the end in the Q&A said, oh if you want to propose a research grant or a clinical study talk to your program officer.  What program officer?  There’s not even, you know, we’re not even inside an institute.  I don’t, there’s no real full-time program officer,  is my understanding, to talk to.  So I think we need staff and I also think we need a major initial funding commitment to make up for the neglect and abuse of past decades that’s on the level of $500 million or more to really get things going.  And I’ve heard you guys say, you know, this is a taxpayer funded institution,  you have to be respectful, but we are the taxpayers.  And I’ll say that whenever a new taxpayer like me is struck with this illness we are infuriated to learn as the degree to which the NIH has abdicated its public health responsibility over the past several decades.  And I’ll say that I think taxpayers don’t want extremely rigorous basic science research into the minutiae of well understood conditions.  They want answers for the ones that could happen to anyone at any time and don’t have any current treatments.  So, in that vein I think the NIH I think even though, you know, you talk about how financially strapped you are and how bureaucratically surrounded by red tape you are, you have many options.  You can create an office within the Director’s Office like there is for HIV/AIDs.  You can fund intramural labs within every single institute.

Right now there is,  my understanding is that there is one clinical study out of twenty something institutes with hundreds of labs.  You can create a Common Fund initiative for finding biomarkers for neuroimmune fatiguing conditions.  Or say for understanding of acquired mitochondrial dysfunctions something broad but extremely relevant to ME/CFS and all the other illnesses that do not have answers right now.  You can create more collaborative research centers, you can issue specific RFAs, you can amend the guidelines of the open grant system to boost the scores of diseases with unmet burden.  You can contract with advocacy organizations to expand their existing grant programs, like the Ramsey Awards which are seed grants.  You can use discretionary funds in the Director’s Office and in every institute.  And if that doesn’t work if that is not sufficient, then it’s on you to get a larger funding stream from Congress through your budget requests.  And I read I saw that Francis Collins just made, just gave testimony for the 2020 budget request on April 2nd, just a week ago.  And in that, ME/CFS was not mentioned as a priority.  There were many things that yes, are also priorities.  But then he mentioned that he was particularly proud of a dedicated fund he’s creating within the Office of the Director of $100 million to support the prioritization of applications from early stage investigators to support budding scientists in general.

Now why is there not a $100 million Director’s fund to support ME/CFS research?  It’s clear that you are actively deprioritizing this research.  And from funding for disease burden calculations ME/CFS comes in literally dead last.  And so my question is, will you commit to truly accelerating research by hiring full time ME/CFS focused staff and identifying one or more major multi-year funding streams before the end of 2019?  Or will you continue to put your responsibility on the backs of sick and disabled people with ME/CFS and their caregivers?  And I’ll just close by saying that you’re taking advantage of the fact that most ME/CFS patients are too sick to storm the NIH.  Or to protest in the streets but, we are creative, and we are committed, and we are building our movement.  And we’re developing alliances with groups like Act Up.  And we will find a way to force your hand if we have to.  But, please, please don’t be the kind of public institution that forces debilitated people who are poisoned by exertion to sacrifice their health and functioning in order for you to fulfill your own public missions.  Thank you.

Dr. Walter Koroshetz:    Okay, thank you.  And we certainly feel the frustration.  We feel the inadequacy in terms of being able to deliver treatments for people who are suffering.  And I think there is a very strong commitment on the part of NIH, the NIH Director to really turn things around, as you said.  And I think a lot of things you mentioned are possible.  Some of them are not possible but we will look at to try to turn over every rock.  To see if we can move the field forward.  I would emphasize though, that the critical piece is that you need in any field a large, well any field that’s complicated such as this with a very large cadre of people who are dedicated scientists working on the problem.  And we are trying to grow that field and that’s really where the answers are going to come from.  I can just tell you from being responsible for many different disorders, that the success comes in an incremental fashion as more and more people come in with more and more ideas.  And so the session that we had for the early stage investigators I think was probably one of the most encouraging things about the conference.  That hopefully we can bring these people and work with the disease organizations such as yourselves to spend their careers on trying to solve this very mysterious problem.

And so we do commit to doing that with you.  We do have Program Directors, Dr. Vicky Whittemore is a Program Director at NINDS, Dr. Joe Breen is a Program Director at NIAID.  And they are working along with Andrew Breeden and the other Program Directors that are part of the NIH Working Group,  to help investigators come in with their grants.  Because NIH is a granting institution and we cannot send money out without grants coming in.  And that is where the actual impetus has to go is to get many, many more applications to come into NIH and then more funds can flow out.  We will put together special programs to try to jump start this because we are working from a very kind of low-level of activity at this point.  But, for sure we all agree with that and we want that to change.  So I understand your frustration and we take it to heart and will do whatever we can to move things forward.  Next question?

Coordinator:   The next question is from Annie Potter, your line is open.

Annie Potter:   Hi, thank you so much.  I wanted to touch base on the question that Dr. Avi Nath mentioned at the beginning of the call,  where he said that they saw a lot of patients who were diagnosed with Chronic Fatigue Syndrome but after running the blood work and the tests they determined that they had an alternative explanation.  And I wanted to ask for those of us who are living in this area, near NIH,  is there a way to come in too, for you to look at our blood and to let us know?  Because if we don’t have chronic fatigue then it would be great to know what we do have.  But other than that, that was it.  Thank you.

Dr. Avindra Nath:   Yes, so let me just answer that for you.  So, the thing is that our inclusion criteria are very strict.  So, you know, the study requires before you can come in you have to meet certain inclusion criteria.  And our study is also focused on only those individuals who have a clear infectious process followed by ME/CFS symptoms.  And so, a number of people get excluded because they don’t really meet those criteria.  And then we need medical records, we review all their medical records.  Oftentimes, just by looking at the medical records, there is actually clear there are other diagnoses there.  And so, they don’t clearly meet the criteria for ME/CFS.  So, the alternative diagnosis can even come before we do the blood testing or anything.  But it’s true that some of them will look like they have all the criteria, they meet our criteria.  Then when we bring them in here, they might come up with an alternative diagnosis. 

So if you meet the criteria for a study we’re happy to enroll you.  And then if you find something else then that would be your diagnosis.  But if you don’t even meet the criteria then I have no way of seeing you over here.

Dr. Walter Koroshetz:   So I guess the answer is the NIH is an intramural program, only takes people on a particular research protocol.  So everyone in the NIH intramural program is on a specific protocol which has inclusion, exclusion criteria.  And that is what I think Dr. Nath was saying that, that’s kind of the stipulation for getting in.  Now I think I would say that the diagnoses that you are coming up with you’ll be publishing those as, you know, these are the kinds of things we found in people who came in.  We don’t think that there is any kind of one thing that’s the big fooler.

Dr. Avindra Nath:  Yes, I mean anything from cancer, to a myositis, to, you know, Parkinson’s Disease.  So there are very obvious diagnoses that somehow are getting missed in the community, you know.

Dr. Walter Koroshetz:  Right, so it’s not a mystery diagnosis out there.

Dr. Avindra Nath:  Yes.

Dr. Walter Koroshetz:  Okay, next question?

Coordinator:  The next question is from Natasha Kellerman, your line is open.

Natasha Kellerman:  Yes,  hi.  So I’ve had ME/CFS for 23 years now this April. That equates to exactly half of my life.  I was able to watch about two-thirds of the conference online.  And I have to say that yes, this has to be the most encouraging thing I’ve seen in the past 23 years.  Of course I do worry given the history that this will be a blip on the horizon rather than a key turning point.  I have two specific questions that relate to how we are translating the research into real-time improvements in clinical care.  And patient decision making.  The one key that I felt was missed at the conference is research studies on pregnant women.  As we know this is primarily a women’s disease.  And I say this as someone who’s been lucky enough to have a daughter, I have a 16-year old daughter.  But I know a lot of women are still forgoing having children which is a really important problem in the community.  And then the second area where I feel we’re lacking too is in the management of chronic disease.  And what we said our illness is not static, right, it changes over time, it evolves.  So someone who’s recently, you know, progress to have sensory motor polyneuropathy.  I would love to see more research and more filtering of knowledge around what this illness is looking like for us old timers.

Dr. Walter Koroshetz:  Boy, I think those are really good questions.  I think those will definitely have to go on our list of things to investigate.  I know Dr. Komaroff, I’m wondering have you had any knowledge about research into women with chronic fatigue and going through pregnancy?

Dr. Tony Komaroff:   There are only a couple of studies that I am aware of in the literature.  Including one that our group did which was very simple.  It basically followed a lot of patients and asked them whether during the course of the pregnancy their symptoms worsened, or improved, or stayed the same.  But it really didn’t, it wasn’t designed to study why things got worse if they did.  And it found that about a third of women have a flare up of the symptoms during pregnancy,  about a third have a remission of symptoms and improvement,  and about a third didn’t really experience much change.  But I don’t know that any grant application to study pregnancy in people with ME/CFS has ever been submitted to NIH.  It’s a hard thing to orchestrate because you have to have enough patients in any one setting to enroll enough people to really learn something.  So it’s a tough -- it’s an important question to study also a tough one to study.  And I’m not sure any investigators out there have proposed to study it seriously.

Which to me just underlines what Dr. Koroshetz said a minute ago.  Which is that of all of the problems in advancing research in this area, the greatest problem in my view is just not yet enough scientists who apply to study the problem.  And therefore, it’s really important that we do more to generate interest among a larger number of scientists.

Dr. Walter Koroshetz:  Okay, could we go to the next question please?  Thank you.

Coordinator:  Our next question will come from Wilhelmina Jenkins.  Your line is open.

Wilhelmina Jenkins:  Thank you.

Dr. Walter Koroshetz:  Go ahead Wilhelmina yes.

Wilhelmina Jenkins:   I’m not, I’m still muted.

Dr. Walter Koroshetz:   No, you’re good, we can hear you.

Wilhelmina Jenkins:  Oh, okay.  Yes, my name is Wilhelmina Jenkins.  I’ve had to this illness for 36 years.  I wanted to mention especially that this month at NIH is National Minority Health Month.  And I know that there is a person from the Institute for Minority Health Disparities that serves on the Trans-NIH ME/CFS working group.  But as I think you all know there is a dire need for more outreach to the medical community that serves African-American and other minority communities.  And also to include African-American and other minority researchers in the research program.

In the time that I have been ill, I haven’t seen any real increase in the number of African-Americans who have been diagnosed with this illness.  And as, you know, we don’t have diagnoses we can’t possibly have inclusion in research.  Especially this month I was wondering if it’s possible for those of you who are working at NIH on ME/CFS to have a particular outreach maybe coordinated with the whole effort of minority health month to historically black medical research institutions for example one is right down the street from you at Howard University,  a strong research institution and minority organizations of health providers.  So that they understand who this is severe illness.  As you know most doctors who serve minority communities are severely overworked.  And if you don’t come in with something on the order of diabetes, cancer,  heart failure, high blood pressure, AIDS, they think you’re pretty much well.

I’ve seen this even with doctors that I have gone to myself over the years.  It’s not something that is on the radar for those doctors.  If there were more doctors and more patients included in your research programs, I believe that information would get out more readily to the larger community.  I know if you look at the patients that come into your intramural study, you’re not getting many minority patients, and neither are most of the doctors who specialize in this disease.  What can you do to change this?  How can you bring in more minority professionals and patients into your research program?

Dr. Walter Koroshetz:   Well that I think is a really good question.  And it certainly has been a struggle in many areas of research at NIH.  And so there has been a lot of activity in this space and some progress  but way less than what we hoped.  So right now researchers as they apply for grants are required to put in a plan for recruitment of participants from diverse backgrounds.  And then we review those plans on an annual basis.  And then when they fall short, we kind of call them up and say, you know, we this is not going well, and we need a plan to try and improve it.  So that’s kind of our general day to day type of process.  But then we’re also always looking at innovative ways to rectify the situation by reaching out to investigators.  Particularly at places where there is a large, diverse population. And so I think that those are things that I’m sure the working group is going to be making recommendations on coming back to Council on how we can best do that.  But again, I agree that, that’s absolutely something that we need to do.

Dr. Vicky Whittemore:  This is Vicky Whittemore, a comment.  We are currently funding a fellow, an MD/PhD student at Howard University who is doing clinical studies and working very hard to in those studies recruit individuals from the minority population.  So it’s one step in the right direction and we as Dr. Koroshetz had said hope to do more of that in the future.

Margo Warren: I’m sorry to say we have time for one more question.  I know there are many of you waiting to ask questions.  And please send any of your unanswered questions to or simply go the NIH ME/CFS website and click on the Contact Us button to submit those questions.  Now, just one more question please.

Coordinator:  The last question will come from Cheryl Bose your line is open.

Cheryl Bose:  Hi, I was one of the people rejected from the intramural study.  And I just want to point out that studying only post-infectious cases as well as studying people with an onset within, you know, the five-year period is a very limited look at this disease.  I’ve been actually seen by four world-class ME/CFS specialists who have all agreed on my diagnosis.  And have, you know, thoroughly ruled out any other possible causes of my illness.  However, because I had some symptoms before I became completely permanently disabled by this illness I was rejected from the study.  I got as far as being interviewed by telephone by Dr. Walitt and was then rejected.  So I just want to point out that not everyone who is rejected from the study has an alternative reason for their ME/CFS.  I also want to ask at what point is NIH going to include those of us who may have had a more gradual onset but still have ended up losing everything in our lives that matters because of this illness?

Dr. Avindra Nath:  Yes, thanks for bringing that up.  And so you make the right point is that yes, you have to meet our inclusion criteria to get into the study.  And the study has pretty narrow inclusion criteria.  And that’s based on by design for two reasons.  One is if you want to study people very deeply and very thoroughly, then you have to have a small sample size unless you want the study to go on for years and years.  So we have a small sample size which is 40 patients and the others are controls.  And we have a lot of investigations we’re doing.  So if you go through two phases, you’re almost in the hospital for almost a month.

So what you want is you want a patient population that is as close as possible to one another.  Otherwise you will find a lot of, you know, variability in your findings.  You’ll never come up with any conclusion at all.  So, I think we’ve done the right thing by trying to define a narrow population to study.  Once you’ve done that, then that information then becomes widely available to the community.  And as other researchers are there in other institutions, they will pick it up and they can do other aspects of ME/CFS.  Everything doesn’t have to be done in the intramural study.  There are going to be a lot of other centers developing, other researchers coming up.  And they will pick their areas of expertise.  My area of expertise is really infectious diseases, it makes sense for me to study those patients where that is an issue.  And where immune dysfunction is most likely going to be something that we can study in these patients.  So that’s how I’ve designed my study.  But there are people with other areas of expertise.  And so they will use that to study this patient population.

Dr. Walter Koroshetz:  So I think the word rejected, that’s a tough one to swallow.  And I think more of it is that you didn’t fit the inclusion, exclusion criteria, so you were excluded.  And to Avi’s point I think the first step oftentimes in research is to try to find what we call a pure homogenous population  because that is your best chance of seeing a signal.  But once you do that you have to basically see whether or not that generalizes across the population.  So that is a step wise type of research process.  So the hope is with the small population we’ll discover signals that then we can go out and generalize into patients who may not fit these inclusion, exclusion criteria.  And the best thing would be if we find something that really is pertinent to a large swath of patients suffering with ME/CFS.  But that really remains to be determined.  But I think that strategy is the issue here and we don’t really want to reject anybody.  It’s just that for the science, to make it work these inclusion/exclusion criteria are critical.  But we hope we can get help to people who fit multiple different criteria for ME/CFS.  So with that I think, Margo?

Margo Warren: Yes.  A recording and transcript of the call will be posted to the NIH ME/CFS website very soon.  In closing the call I’d like to remind you about our list serv for updates from NIH. To be added to the list serv please visit the NIH ME/CFS website, which is and click on Join Our List Serv at the bottom of the left sidebar.  Thank you so much for joining the call today.  It was an informative and thoughtful discussion.  Good afternoon.

Coordinator:  Thank you for your participation on today’s conference call.  At this time all parties may disconnect.

This page last reviewed on April 26, 2019