October 23, 2018

NIH ME/CFS Advocacy Call - October 2018

Coordinator: Welcome and thank you for standing by. At this time all participants are in a listen-only mode. At the end of today’s presentation we’ll conduct a question-and-answer session. To ask a question, please press star 1.

Today’s conference is being recorded. If you have any objections you may disconnect at this time. I would now like to turn the meeting over to Alissa Gallagher. You may begin.

Alissa Gallagher: Good afternoon. My name’s Alissa Gallagher and I’m from the Office and Communications and Public Liaison at the National Institute of Neurological Disorders and Stroke. On behalf of the NIH, I would like to welcome you to this afternoon’s teleconference and to thank you for your interest in participating in this discussion with us today.

Dr. Vicky Whittemore, Program Director at NINDS who helps coordinate NIH’s efforts in ME/CFS will introduce the speakers, each of whom will make some remarks. Afterwards we’ll open the phone call for your questions. We will try to make our remarks brief so that we can answer as many questions as possible in the time that we have available to us this afternoon. We also request that everyone ask only one question so that we can hear from as many of you as possible. Now I’ll turn it over to Dr. Whittemore.

Dr. Vicky Whittemore: Thank you. Good afternoon everyone and welcome to the 3rd tele-briefing of 2018. I am Vicky Whittemore and I help lead the Trans- NIH ME/CFS Working Group. Dr. Koroshetz, who chairs the Working Group had hoped to be here today but he has a scheduling conflict and was unable to attend. But he sends his regards to everyone.

Since our last call there have been a lot of developments at NIH related to ME/CFS and we’re excited to update you on what we’ve been doing. In a few moments I’ll provide updates on the new NINDS Council Working Group for ME/CFS research, I will also describe the latest activity in the collaborative research centers including the PI meeting that took place last week at Jackson Laboratories in Connecticut. Dr. Joe Breen is here and he will provide updates on the upcoming research meeting in April that we’re very excited to be hosting here on NIH campus.

Dr. Nath, who’s intramural here at NIH at NINDS will also update us on the intramural study. We’re delighted to be joined also by Dr. Maureen Hanson who’s the PI of the CRC at Cornell University in Ithaca, New York. She’s the Liberty Hyde Bailey professor in the Department of Molecular Biology and Genetics and the Director for the Center for Enervating Neuroimmune Disease at Cornell.

In the Cornell Collaborative Research Center, Dr. Hanson and her colleagues will investigate the biological mechanisms underlying ME/CFS by obtaining blood samples and conducting brain scans on individuals with ME/CFS before and after they undergo an exercise test designed to bring on symptoms of post-exertional malaise. Dr. Hanson’s team will use a wide range of tools and technologies to test the role of genes, inflammation in the immune system in the disease.

We also want to remind everyone that while ME/CFS is a Trans-NIH effort, NINDS is the lead institute for this disease. The trans-institute working group is composed of 24 representatives from different institutes and centers and offices across NIH and we still continue to work very closely together to support and stimulate and accelerate research on ME/CFS. As always we’re eager to hear from you so we’ll keep our own remarks very brief before opening the phone lines for your questions.

I would first like to give you an update on the NINDS Council Working Group for ME/CFS research and this is a group that we’ve recently put in place. We’ve had two teleconferences now and the group is chaired by Steve Roberds, Dr. Steve Roberds, who is the Chief Scientific Officer at the Tuberous Sclerosis Alliance. We chose and asked Steve if he’d be willing to chair this group because of his, both expertise in research, he is a neuroscientist and pharmacologist and has worked in both academia, pharmaceutical companies, and now at a non-profit. Because of his background as well as the fact that he is a member of our NINDS Council and we are required to have a council member on the working group. The rest of the working group is then made up of ex-officios from CDC and NIAID, Dr. Breen and Dr. Unger, as well as then other advocates, individuals with ME/CFS, clinicians, and researchers.

Second meeting we just held yesterday, yes Tuesday, today’s Tuesday, was essentially a meeting to get organized, to really talk about what our work package will be in the end, and how we’ll go about gathering information to help develop the recommendations that this working group will bring back to the NINDS Council.

It mainly focuses, the discussion focused, on really understanding the state of the research, what infrastructure needs there are, where are gaps in opportunities for research going forward, and how can NIH and working with other federal agencies, how can we work together as federal agencies as well as together with the patient advocacy groups to really move research forward in this area and what’s needed on the federal as well as in the private sector to make this happen.

From there I’ll move on to an update about the CRCs and the Data Management Coordinating Center. On October 15 we had an all-day meeting that was held and hosted at Jackson Laboratories in Connecticut by Derya Unutmaz. He’s the PI of the center, ME/CFS collaborative center there at Jax. We had over 50 people in attendance, so not only were the principal investigators from each of the centers there but they also had brought along graduate students, undergrads, other collaborators who are participating in the research at each of the centers.

The full day of exchanging information about the research that’s ongoing, challenges they’re having, ways in which that they can collaborate. We talked about everything from metabolomics to epigenetic to imaging studies and it was a very fruitful day. As you know they’re just beginning their second year of funding. Many of the studies have just begun recruiting study participants. It’s early days and there isn’t a lot – wasn’t a lot of actual data presented.

But I think it was a very good exchange of information about what’s going on in each of the centers and ways in which they can not only collaborate but also standardize some of the studies that are being done across the centers such that instead of having individual groups update us from each of the centers, we will be able to combine that data and make much more meaningful conclusions from the data in the end. With that I will move on and ask Dr. Breen to give an update about the research conference in April 2019. Dr. Breen?

Dr. Joe Breen: Thank you Vicky. My name’s Joe Breen and I’m a Program Officer in the National Institute of Allergy and Infectious Diseases and I work with Vicky and others on the NIH ME/CFS working group and actually manage one of the three CRCs on behalf of NIAID.

I’d like to tell you a little bit about the upcoming research conference that we’re going to be having here on the NIH campus in April. It’s April 4 and 5 in 2019. It’s called “Accelerating Research on ME/CFS.” It’ll be two full days of research talks and panel discussions. We’re very excited to have Dr. Jose Montoya from Stanford and Dr. Maureen Hanson, who you’ll hear from later, from Cornell as co-chairs for the meeting.

We have an organizing committee that includes researchers primarily funded by NIH, as well as stakeholders in the community from patients to patient advocacy organizations and also NIH staff to come up with an agenda to really try and give us the fullest accounting we can of the state of research and also try to synergize and really think about what needs we can accentuate moving forward.

The hope is having this meeting here on the NIH campus we can also offer that up to the large research community here at NIH. Of course it’ll be an open meeting and I should add it will also be webcast so that people with – who couldn’t possibly travel will also be able to see the conference as well. We’re developing the agenda with the organizing committee and our co-chairs. We actually have another call next week.

I expect in the next few weeks we’ll have an agenda to start inviting people to come attend. This meeting actually will follow directly a meeting that’s organized by NINDS for young investigators that perhaps Vicky would like to talk about.

Dr. Vicky Whittemore: Sure, thanks Dr. Breen. The conference itself that Joe talked about will take place on April 4 and 5, and the day before, April 3, we’re organizing a one-day workshop for young investigators that will bring undergrad, graduate students, and post-docs together to work with NIH program staff across NIH on grant writing skills.

We’ll be inviting researchers and clinicians from ME/CFS community to participate as well and we’ll work on career development issues as well as then providing time in the afternoon for them to present their science to one another and get critiqued and get advice from each other to really begin to help build a pipeline of young investigators who can follow on from the excellent, and contribute now and follow on from the excellent researchers we currently have involved in ME/CFS.

We’ve recognized for a while that this is a significant issue in ME/CFS research. This is an attempt to try to bring these young investigators together to really help encourage and support them as well as to build a network that they can then begin to support each other as well and to collaborate and communicate amongst themselves as a network of young investigators in this research area.

We’re looking forward to that particular conference and the young investigator conference, that is, workshop. Did you have anything else Dr. Breen?

Dr. Joe Breen: I don’t.

Dr. Vicky Whittemore: Okay. From that we’ll move on to Dr. Nath who has joined us. He’s away at a conference. Thank you, Dr. Nath for joining us for an update on the intramural study.

Dr. Avi Nath: Thanks Vicky. I don’t really have anything new to report. Things are coming along really well. Recruitment is continuing and everything’s progressing as planned, so I think we’re on target.

Dr. Vicky Whittemore: Excellent, thank you for joining us. We’ll move on now to Dr. Maureen Hanson who’s going to give us an overview of the research that’s going on at the Cornell Collaborative Research Center for ME/CFS. Dr. Hanson?

Dr. Maureen Hanson: Thanks. Actually you gave a very good summary of the goals of our center and I’d also like to mention that there’s a lot more information about our center’s projects that you can read about at neuroimmune.cornell.edu. Especially I would suggest looking at the News section of that website, which has useful information about how subjects can participate in our studies as well as it has a number of links to presentations that I’ve done that’ll allow you to learn a lot more about our center than I could possibly give in a few minutes on the phone.

Recently I gave a presentation at the webcast Stanford symposium in September. That’s available on YouTube. Another presentation that can be obtained is a presentation that I did at the Invest in ME meeting last June that can be ordered from Invest in ME. You can receive the DVD that has the presentations of all the speakers at the patient meeting.

Finally I gave a talk at the Solve ME/CFS Discovery Forum last October in which I outlined the three projects that our center will be carrying out. The first one of those projects is a neuroimaging project that will be assessing neuroinflammation in the brain before and after an exercise challenge. That’s being carried out by Dr. Dikoma Shungu at Cornell Medical School. Then my project being carried out in my laboratory is a project to study the role of extracellular vesicles in ME/CFS.

We’ve been doing some pilot studies on samples without exercise. We’re going to be looking before and after but to get our technology fine-tuned we’ve done a pilot study to observe whether the cargo inside these extracellular vesicles is different in patients versus controls. We have some interesting data indicating that the cytokine content of these vesicles is different in patients versus controls.

Finally, the last study that’s being carried out, project – the third project is being led by Dr. Andrew Grimson who will be performing single-cell RNA sequencing on white blood cells from patients and controls. He’s also been fine-tuning the methodology for this very new method that has been quite useful to identify differences in the immune system between people who have various diseases. I think it’ll be quite important to study this in ME/CFS.

That’s basically an overview of what we’re doing. We are actively screening and testing people at this time and that’s going to be continuing on for the rest of the year and also next year. There’s plenty of opportunities for subjects to volunteer to participate. To do that please have a look at the – at our website with the appropriate numbers that you’d – email I mean, appropriate emails that you’d contact people in New York City or in Ithaca if you want to participate at the Ithaca or the Los Angeles site. That’s pretty much what I have to let you know about right now.

Dr. Vicky Whittemore: Great thank you Dr. Hanson. At this point we’ll open up the lines to your questions. We look forward to your questions and seeing how we can provide more information for you.

Coordinator: At this time if you’d like to ask a question please press star 1. Please unmute your phone and record your first and last name clearly when prompted as well as your affiliation. Both pieces of information are required to introduce your question. To withdraw your question you may press star 2.

Once again at this time if you’d like to ask a question please press star 1. Our first question is from Denise Lopez-Majano with Advocate. Your line’s open.

Denise Lopez-Majano: Good afternoon, thanks very much for the call. There’s been an awful lot said today that is very, very interesting and it raises an awful lot of questions in my mind. One of my first questions though is when is NIH going to issue a program announcement specific to ME/CFS?

Given that investigator initiated funding has dropped by 30% in 2018 it seems like an easy way for NIH to advertise how serious NIH is about ME/CFS grant funding. As Dr. Collins said in 2015, give us a chance. The last program announcement was in 2015, seems like it’s more than time for another one. Another question I have is for Dr. Nath. That is, I understand that no patients for the Lyme control group have been identified yet for the intramural study. I was wondering how that’s going to be pushed. Thank you very much.

Dr. Vicky Whittemore: Thank you for the questions. Dr. Nath do you want to answer the question about the Lyme disease patients first? Dr. Nath? Okay. Are you muted Dr. Nath?

Coordinator: Looks like he’s still connected. He may be on mute.

Dr. Vicky Whittemore: Okay. I’ll go ahead and answer the first question that you had Denise. We’re very concerned about the low number of grant applications that are coming in and we were considering issuing a program announcement but NIH has just announced that they’ll no longer issue program announcements and instead they’re putting a different process in place for special topics of interest. We’re exploring what that process will be and are interested in pursuing that.

We certainly are talking to individual investigators. We put them in touch with the appropriate Institute and appropriate program director to try to assist them as they submit their applications and are encouraging individuals to submit grant applications to NIH. We’re looking at ways in which we can really try to bolster the number of applications that are coming in to NIH. Dr. Nath, are you available? We’re not hearing Dr. Nath so we’ll come back to that question Denise if he’s able to rejoin us later. Next question please?

Coordinator: Our next question is from Wilhelmina Jenkins. Your line’s open.

Wilhelmina Jenkins: Thank you. I’m going to follow up a little bit on what Denise said about the need for urgency at the moment. It’s been very disturbing in the patient community to see that 30% drop in individual grants. We understand it’s because of the low number of applications to grants that are coming in. However, MEAction submitted a long list of methods of hopefully improving the granting situation.

It was a very thorough list of 11 different methods within the NIH doing things that would help. I’m wondering if you might be working on those through the working group. I know that Dr. Collins and Dr. Koroshetz aren’t here but if either one of them has considered that list of possible means of improving the research community. This has been a very long and agonizing struggle for most of us.

I’ve been ill since 1983. I was diagnosed in 1988. I haven’t been able to work since 1987. I also have a daughter with this illness and my big hope in life is to get some serious research done in my lifetime. I’ll be 69 next month. This has been a long struggle but what we need to see is some more urgency. I’m really wondering what happened with those recommendations. They were well thought out and effort was made to make sure they were within NIH guidelines.

I know it’s hard to jump start but considering the responsibility the NIH has for – in the past and I understand it’s a different group of people but in the past it’s been NIH’s fault that this has slowed down to such a horrible crawl. Aside from the working group are you looking at any other mechanisms to get things underway?

Dr. Vicky Whittemore: I’ll answer your question in several ways. First of all, yes, the Trans-NIH Working Group, which is our internal NIH working group, is looking at those recommendations. We’re also working together with the NINDS working group of council of which MEAction is a member. Jen Brea is a member of that working group. Those recommendations are being considered as part of the work of the working group and will be considered as part of their recommendation.

In addition, I do know that MEAction requested a meeting with Dr. Collins and they’re attempting to finalize a date with MEAction in December for that meeting. Those recommendations will also be addressed at that meeting and ways in which NIH can begin to address the recommendations that were made in the petition. Yes. Thank you for that question, next question please.

Coordinator: Our next question is from Eileen Holderman. Your line’s open.

Eileen Holderman: Yes, good morning. This is Eileen Holderman. My question is for Dr. Nath if he’s back on the line. Is Dr. Walitt still on the NIH intramural study? If not, why not and who replaced him? My second question is I noticed that all the NIH committees and workgroups that are formed around all these initiatives are comprised of organizations or individuals who promote SEID, the IOM definition and name.

I’m wondering especially in light of this upcoming April conference if NIH is going to balance the stakeholder representation and invite a group such as meadvocacy.org and independent advocates like Gabby Klein or myself, Jeanette Burmeister, to be a part of that since we’re very public about our opposition against utilizing the IOM criteria and name. Thank you.

Dr. Avi Nath: This is Avi here. I’ll take the first part of your question. Yes, Dr. Walitt is very much part of our team. There are no plans to replace him. He’s doing a great job.

Dr. Vicky Whittemore: Dr. Nath can you, while we have you also address the question that came up about recruitment of the Lyme patients for the intramural study. What’s the status, when will they be recruited?

Dr. Avi Nath: When will who be recruited, I’m sorry?

Dr. Vicky Whittemore: The post-Lyme patients.

Dr. Avi Nath: The post-Lyme, yes. Adriana Marques, she’s the expert on the Lyme study. She wanted a number of amendments to the protocol for that purpose. We’ve put those amendments in and as soon as they get approved I think she’s going to start recruitment and see if we’re able to recruit some of those patients or not.

Dr. Vicky Whittemore: Thank you.

Dr. Avi Nath: Sure.

Dr. Vicky Whittemore: I’ll answer the part about the involvement of advocates in the working groups. Specifically, for the NINDS working group of council we’ll be having, we’re planning, several focus groups and we’ll be soliciting information from anyone who wants to participate in those focus groups.

The working group is planning to have a meeting coming up where we’ll really begin to finalize what those focus groups will look like and when and how they will be held, probably by webinar I’d guess. We’ll get more information out to everyone as soon as those are planned. We certainly will be soliciting that information. Thank you for those questions, next question please.

Coordinator: Our next question is from Mark Camenzind with Cure ME. Your line’s open.

Mark Camenzind: My name’s Mark Camenzind and my son has a very severe ME. He has such severe light sensitivity, a starry night would make him scream and I don’t think they’re looking enough at light sensitivity. Then CFSAC was a good forum for getting all the other agencies together, CDC, FDA, Veterans Administration and the like. That’s gone away, which is just unconscionable.

We need to have more focus not just at NIH but providing more fair funding going toward $200 million which would be fair per year based on DALYs or disease burden and anything less is gross discrimination.

You are ramping, I give you credit for that, but you have to ramp up much faster. I worry about my son dying daily and this is just not fair for 1 to 2 million who are ill in the United States. I hope you can ramp up much faster and include a lot more emphasis on degree of light sensitivity just not am I a little sensitive to light but many are extremely sensitive to light or sound. I think looking at biomarkers for that, do you have autoimmunity to neurotransmitters. What’s going on could provide insight for the less severe cases also. Thank you.

Dr. Vicky Whittemore: Thank you Mark. I’ll take that suggestion about the light sensitivity back to the Trans-NIH working group. I think that’s very interesting and you’re right. That’s not something that at least to, my knowledge is currently being explored, but should be, so thank you for that suggestion. With regards to CFSAC, we were not aware that CFSAC was going to be sunset.

There is still communication between the Federal agencies and we’re looking – again one of the things that the NINDS working group of Council will be doing is helping us to put an infrastructure in place for continuing that communication and collaboration between the agencies. I think what CFSAC helped to do was to identify who those individuals are within each of the Federal agencies.

Whenever we do need to communicate with them, we are, just not in a formal setting like CFSAC. We look forward to – and I agree. It’d be great to have greater and broader partnerships with other Federal agencies. Next question please.

Coordinator: Our next question is from Leonard Jason with DePaul University. Your line’s open.

Leonard Jason: Thank you. Vicky you mentioned that PAs are going to be discontinued at NIH. I’m wondering if RFAs are also going to be discontinued and if they are not going to be discontinued, is there any possibility of there being an RFA for this field?

Dr. Vicky Whittemore: Program announcements are being discontinued but RFAs are not. I think the distinction is that RFAs typically do have some set-aside funding associated with them, whereas program announcements are essentially just an announcement that we’re interested in receiving grants in a particular area of research.

In addition, there will continue to be program announcements, what are called PARs, which are program announcements that have special review. What that means is that you can have a program announcement with a specially established review group, a special emphasis panel for review. You can also – we’ll be able to have a program announcement with set-aside of PAF, which means a program announcement with specific funding.

We’re are – one of the things on the working group of Council list of things to advise us on, are moving forward whether we should issue any of the PAR PAF category or RFAs. We also are planning to do a survey and discussions with the community about the research gaps to really understand where the research needs are.

It’s one thing to put out a very broad research funding announcement whereas it sometimes it’s much more beneficial if it can be more focused areas of need. Those are some of the things that we’re looking into as to how to be most effective and to really stimulate the research that needs to be done next in ME/CFS. Thank you for that question and hopefully we’ll be able to move on those kinds of things in the near future. The next question, please.

Coordinator: Our next question is from Annette Whittemore with Whittemore Peterson Institute. Your line’s open.

Annette Whittemore: Thank you, yes. This is Annette and my question is for Dr. Nath. I noticed that he has made some progress in HERVs, human endogenous retroviral expression. In MS and ALS both with MS HERVW and ALS HERVK and I was wondering, is he pursuing studying the activated HERVs as the potential pathogenic mechanism in ME/CFS and if not would it be possible to take that up with the intramural study group?

Avi Nath: Thanks very much for that question. The answer is yes. As you know endogenous retroviruses were once looked at previously in ME/CFS and the initial reports didn’t really pan out. It turned out to be all contamination. We have to be very careful in looking at these endogenous retroviral elements. Our lab is, – has a lot of expertise in that area and so it makes sense that we’ll definitely look at it. If it pans out, remains to be seen.

Annette Whittemore: I was thinking of endogenous retroviruses versus exogenous and…

Avi Nath: Yes, endogenous.

Annette Whittemore: Right. That’s very encouraging. Thank you so much Dr. Nath.

Avi Nath: You’re welcome.

Dr. Vicky Whittemore: Thank you. The next question please?

Coordinator: Our next question is from Deborah Waroff with ME/CFS. Your line’s open.

Deborah Waroff: That should be ME/CFS Alert, I’m sorry. I see a lot of programs where money is flowing like the river in spring, notably Precision medicine and the BRAIN project. Of course, the AIDS budget of $3 billion, which Dr. Nath is associated with and where he does a great deal of work related to issues of encephalomyelitis or encephalitis or other forms of brain dysfunction such as are seen in ME. I’m wondering what the current trans-NIH group might think of doing to implant our work in some of these areas of research that are hugely funded. Thank you.

Dr. Vicky Whittemore: Thank you for the question Deborah. As you know many of these programs are addressing current issues such as the opioid addiction problem. NIH has put in place a program to deal with not only opioid addiction but also pain mechanisms and non-opioid treatment for pain. Those programs are actually just being formulated and the RFAs released – I think some of them have been released or will be released soon.

I’d expect and hope that some of those programs that deal specifically with pain could also involve research on pain as it is involved in individuals and treatment of pain for individuals with ME/CFS. Some of the other initiatives such as the BRAIN Initiative, they are currently – let me back up. The first part of the BRAIN Initiative was really to develop new technologies to study the brain.

They’re now moving into ways to apply that technology to studies of the brain – of the brain and brain disease and disorders. Again I’d think that and hope that there’d be investigators out there that could utilize some of the initiatives and RFAs that are coming out within the BRAIN Initiative to apply those new technologies and request funding or submit grant applications as they apply to studies in ME/CFS.

I think that there’s a need obviously for additional research but I think there’s a need to try to also bring individuals outside the ME/CFS field of expertise, say in brain imaging, in pain treatment to the ME/CFS research community. This may be a way in which to do that.

Coordinator: At this time I’m showing no further questions.

Dr. Vicky Whittemore: Are there any additional questions that anyone has for either us or for Dr. Hanson?

Coordinator: At this time I would like to remind participants if you would like to ask a question at this time please press star 1. We do have a question from Eileen Holderman. Your line’s open.

Eileen Holderman: Yes hello. I just wanted to go back to the question that I had. I feel like it wasn’t really adequately answered and I wanted to give you the opportunity to fully answer my question. That is why when NIH makes the selections for the stakeholders such as the committees and workgroups and such for all the different projects, why isn’t there more balance of stakeholders, the stakeholders that are openly opposed to the IOM criteria and definition. How are you going to ensure more balance going forward?

Dr. Vicky Whittemore: Sorry I didn’t answer your question before Eileen. In large part especially for the working group of Council we – the advocates from the – and the organizations that were selected are those that we have been in communication with and working with actively and those like Solve ME/CFS Initiative who actively fund research.

I think that we’re open to lots of opinions. I think we’re looking forward to having those opinions put forward to us through focus groups, we may do a Request for Information in the future. I don’t want anyone to think that we’re trying to bias our work product or the way that we’re moving forward by only selecting individuals from certain organizations.

I think it’s in large part the people that we have been actively engaging with and who have stepped forward to be willing to work with us on these working groups. I encourage you to be in touch with us as we put your voice forward. We’re certainly willing to talk with you and to hear your opinions as well.

Coordinator: Our next question is from Donna Pearson. Your line’s open.

Donna Pearson: Hello it’s Donna Pearson. I’m wondering if Dr. Nath might be able to share with us some of the reasons so many of the people were screened out of the NIH study.

Dr. Vicky Whittemore: Dr. Nath?

Coordinator: Okay. It looks like he actually dropped off of the call.

Dr. Vicky Whittemore: Donna thank you for that question I can try to answer. I’ve heard him answer this question before. Starting with the first screen, the first screen typically screens out individuals who are not within the age range that they’re recruiting, don’t meet other criteria and/or are found to have had ME/CFS for longer than the three years as part of their recruitment criteria.

That’s the first screen. The second screen is typically done my understanding through a phone call with the individual. Very often then they identify that the individual has either other significant underlying diseases or co-morbidities, other things that would disqualify them from participating. And then there’s an additional screen that happens once they’re brought into – they qualify. They review their medical records and they bring them to NIH. After the first visit, then individuals are screened through an adjudication committee that then determines whether this committee truly believes that this individual has ME/CFS, fits all the inclusion criteria in order to move forward in the study.

I don’t think – and I may be wrong. I don’t think that they’ve excluded anyone that’s come in for the first part of the study from them continuing in the study. I may be wrong about that but I think they have such strict inclusion criteria that by the time you get to actually coming to NIH the number of individuals that are invited to participate have really been reduced from the number of initial inquiries.

I think that there clearly are other issues around just scheduling and getting people to come into NIH. That can be difficult depending on the individual’s health, their schedule complicating things. I know for example with one individual that was going to come and then she became pregnant so then couldn’t participate in the study. I think there are lots of reasons around why people are, in the end, excluded from the study.

I hope that answers your question. We can have Dr. Nath address that when he’s on the next call, next question please.

Coordinator: Our next question is from Eric Johns. Your line’s open.

Eric Johns: Yes hello. My question was also for Dr. Nath who’s not on the call now. I was wondering what the methodology is for recruiting patients with persistent Lyme disease or chronic Lyme. It seems concerning that nobody has been recruited thus far so I’d like to know the methodology.

Dr. Joe Breen: This is Dr. Breen. Dr. Nath made a reference earlier. Dr. Adriana Marques is the investigator who’s leading that effort. She’s done changes to the amendment for the protocol that she needed to have completed before she started recruiting. It wouldn’t make sense to change it midway and what Dr. Nath said is that those amendments should be accepted soon and then she can start recruiting.

That’s – there’s no functional reason. It’s really a paperwork issue that she had some amendments most likely to improve the protocol based on what’s happened already before she started recruiting the post-Lyme patients.

Dr. Vicky Whittemore: Thank you, next question please.

Coordinator: Our next question is from Leonard Jason with DePaul University. Your line’s open.

Leonard Jason: Yes, thank you. This has been extremely helpful and informative, so thank you all for participating. I had a question about really how do we attract new people to the field particularly young investigators. I think the funding opportunities and the types of mechanisms that are being talked about are certainly important and positive. One question I have is, is it possible that there’s an impediment or a hurdle for new people who might come into the field and be saying to themselves how do I select research participants if some are suggesting that the SEID/IOM clinical criteria should be used?

Others are suggesting that maybe the Canadian Consensus Criteria should be used and some others are suggesting MEICC should be used. Others maybe Ramsey criteria. There’s different criteria that are being recommended. Is that possible that could be an impediment to interesting people who really want to have a consensus on this issue if they’re going to get interested in pursuing research in this area? Thank you.

Dr. Joe Breen: Dr. Jason this is Dr. Breen. I think that’s part of what makes it challenging to get younger investigators engaged. It’s because it’s a complex landscape and the bottom line is that the biology is still very challenging. I think we have to continue to do some of the things that we’re doing and try to come up with new creative and innovative ways to bring young people into the field, such as the young investigator forum, having meetings where we can talk about the latest research results and try and bring in expertise that maybe would be applied to this disease from outside investigators.

We really try and build a case that there’s a tremendous biological question at play here we want to encourage people to get involved with. I think it’s really hard. That’s part of the hurdle we are up against and tools like RFAs and program announcements are part of that but also trying to let people understand where the gaps are in the field and what are the opportunities as well, what are the recent findings that really generate some interest, perhaps for example, discovering a biomarker that might help differentiate some of the challenges that you outline.

We’re certainly hoping that some of the things that we’re supporting in the CRCs will lead to that. I think that just represents where we are today and we try and bring as many of our tools as we can to try and increase. As we’ve heard we can always do better and we need to keep working toward that aim.

Dr. Vicky Whittemore: Great, thank you for the response Dr. Breen. Next question please.

Coordinator: Our next question is from Denise Lopez-Majano with Advocate. Your line’s open.

Denise Lopez-Majano: Hello again. My question is for Dr. Hanson. You mentioned the extracellular vesicle study that you’re doing and there seems to be a difference in cytokines in people with ME and controls. I’m wondering if there’s other illness groups that are being looked at as well to differentiate whether the cytokine difference is just a result of illness or specific to ME. Thank you.

Dr. Maureen Hanson: In our study we’re not looking at another illness group. But there are studies being done in other diseases where people are examining cytokines in extracellular vesicles. What’s interesting about those, there was a recent paper that was quite interesting showing that the cytokines that are in the extracellular vesicles are different from the ones that are in plasma. All the studies that you’ve heard about that have been done on ME/CFS and controls before were comparing the cytokines in plasma or serum between patients and controls.

It does turn out and we also have data like this that the plasma cytokines are different than the cytokines that are compartmentalized in these extracellular vesicles. I think there’s – extracellular vesicle is a fairly new area of research. I think there’s a lot to be learned about but I do know there’s work underway to study the role of extracellular vesicles in cancer and diabetes and Alzheimer’s disease.

There’s going to be a lot of information from other diseases that we’ll be able to compare to our results with ME/CFS. The other aspect about our work that allows us to make conclusions about the role of, for example, any of the features we’re studying. We’re able to use the patients as their own controls because we are comparing them before they undergo post-exertional malaise and after.

We’ll be able to see it. We’ll be able to find out what happens after an exercise challenge so that we can look at a patient in two different states. That allows us to learn a lot more about the individual patient and how this phenomenon of post-exertional malaise is created by examining the same person in two different states. Thanks for your question.

Dr. Vicky Whittemore: Thank you, next question please.

Coordinator: Our next question is from John Martin. Your line’s open.

John Martin: Hello. I’d like to encourage NIH to look back at some of the research that I did some time ago showing atypical viruses which are referred to as stealth adapted viruses. The cause are commonly present in CFS patients and the reason for bringing this up again we have extended our work to show a non-immunological defense mechanism against these atypical viruses.

I’m happy to hear back from any of the members to expand upon this work that I know that if the effort is made to culture viruses in CFS patients they will turn out positive. I look forward to any feedback. Thank you.

Joe Breen: John this is Dr. Breen. I appreciate your input and I’d like to know more about it, actually. We do have Dr. Ian Lipkin is doing some scanning for viruses but there’s no guarantee that he’s looking in the same viral family that you’re talking about so I’d like to follow up if it’s possible.

John Martin: I’m happy to do so. Thank you.

Dr. Maureen Hanson: I’d like to add that I’d be glad to have you email me information about your studies. My email address is easily found on Google by Googling my name. I’d be glad to learn more about your studies as well.

Dr. Vicky Whittemore: Thank you, next question please.

Coordinator: Our next question is from Mark Camenzind with Cure ME. Your line’s open.

Mark Camenzind: Yes this is Mark Camenzind. We have a Senate resolution 508 trying to raise awareness which is great but we need to have all the states aware. Once we do we need to have the NIH work with CDC to assess what’s the incidence or the prevalence of this disease throughout every state. Right now we don’t really have good statistics. I’m wondering can NIH coordinate with CDC so that we can get states to ask similar questions.

California has a state survey for example done every year and then they could start getting much better statistics and find out if there’s clusters and geographical issues like mold or whatever, who knows or other issues. And then there’s NIH does a lot of things intramurally. We need to look internationally also. The World Health Organization recognized ME since 1969 I think it is, ICD 93.3. Is there coordination with the World Health Organization.

The solutions could come from anywhere, Russia looking at peptides, Japan, Australia, wherever. It needs to be coordinated internationally and then Open Medicine Foundation just had a stellar conference September 29, my wife and I attended at Stanford, 300 people there, 1400 people online. I didn’t see any NIH people or can they participate in these forums to see the best available international researchers from Norway, Sweden that may not travel every day to NIH? It’d be great if they did and participate more. Or did they watch this online. Anyway it’d be nice to have them there. Do they participate in these conferences? Thanks.

Dr. Joe Breen: Thanks for your question. I guess I want to address, I’ll do the last one first. The Open Medicine Foundation Forum actually, that was available on the Web and I did register and watch part of it. I couldn’t travel there. Actually Dr. Hanson mentioned earlier that she participated.

I know that many of the people that we support participated in that forum which sounded like a real success. We definitely are open and we have good communication with the Open Medicine Foundation in trying to really share information since again there are a limited number of folks who are working on this disease. We try and synergize however possible. I think that was a great conference by all accounts.

I have spoken to many people myself who were there. With regard to the international collaboration we’re beginning to do that with the CRC program and we, I believe we have some Canadian collaborators that hopefully will come online soon and we’ve had some discussion with other entities who might participate in our collaborative research center network. I’m not aware of a WHO connection to be honest.

Dr. Vicky Whittemore: I can address that. I know that there’s a lot of activity with the ME groups in the UK and the WHO. We have been in contact with those groups, Action for ME, in particular who has worked quite well with WHO. We’re very aware of that work and as Dr. Breen said we’re very open to collaboration and to really communicating the science that’s happening around the world.

I personally will be traveling to Australia to attend the conference there. I also, because it was our fiscal year end, was unable to go to the OMF conference but did also watch it online. I think that in the future we can attempt to attend in person but it just wasn’t fiscally possible this year. With regard to your first question about the CDC and epidemiology I agree that I think it’s really critical to get a better understanding of the actual numbers of individuals who are affected by ME/CFS.

I think it’s difficult because difficult in the diagnosis. I think that’s something we can take back to our colleagues at the CDC and discuss how we might approach this in a unified way.

Alissa Gallagher: Okay. It looks like we have time for one more question. I know some of you are still queued up waiting to ask questions of us. We’d invite you to send any of your unanswered questions to braininfo@ninds.nih.gov or simply go to the NIH ME/CFS website and click on Contact Us to submit those questions. Now, one last question please.

Coordinator: Our last question is from Donna Pearson. Your line’s open.

Donna Pearson: Oh hi. Something that Dr. Jason asked and then the response to it made me uncomfortable. He implied that the IOM definition can be used for research and the response almost seemed to imply that you guys agreed but in fact the IOM was very clear that they were only creating a diagnostic criteria. Can you speak to that?

Dr. Joe Breen: I think that was probably my answer. I didn’t mean to imply that. I think what I was trying to say is that we would like to find objective biological biomarkers because that would help alleviate some of the concern with trying to define the disease and then would hopefully lead to a more accurate and faster diagnosis frankly. That’s really what I was trying to get at.

Alissa Gallagher: Okay. In wrapping up this call I just want to remind everybody that a recording and a transcript of the call will be posted to the NIH ME/CFS website next week. I’d also like to remind you about our listserv for updates from NIH.

If you received a message about today’s call from the NIH ME/CFS Working Group then your email address has already been added to the listserv. If you received a notice from a friend but would like to be added to the listserv please visit the NIH ME/CFS website at www.nih.gov\mecfs and click on “Join our listserv” on the bottom of the left sidebar.

Thanks to all of you again today for an informative and thoughtful discussion and we hope you have a good afternoon.

Dr. Vicky Whittemore: Thank you everyone.

Coordinator: Thank you for participating in today’s conference. All lines may disconnect at this time.


This page last reviewed on November 6, 2018