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CFSAC June 20, 2018 Webinar Day 1 Transcript

Moderator: Syreeta Evans

June 20, 2018

7:57 am CT

Coordinator:     Welcome and thank you for standing by.  All participants will be able to listen only until the question and answer portion of today's conference.  To ask a question, please press start 1.

Today's conference is being recorded.  If you have any objections, please disconnect at this time.  I would now like to turn your conference over to Mr. (Gustavo Ceinos).  You may begin.

(Gustavo Ceinos):Hi.  Good morning from Washington.  And welcome to the first CFSAC of 2018.  The second meeting will be an in-person meeting held here in Washington hopefully in December.

Let's start with roll call please.


(Faith Newton):Good morning.  And roll call.  (Jose Montoya).

(Donna Pearson).

(Donna Pearson):Present.

(Faith Newton):(Cindy Bateman).

(Cindy Bateman):Present.

(Faith Newton):(Amrit Shahzad).

(Amrit Shahzad):Present.

(Faith Newton):(Gudrun Lange).  I lost you.  Can you hear me?

(Gustavo Ceinos):Yes, we can.

(Faith Newton):Okay.  Good.  (Gudrun Lange).  (Gustavo), do I needed to go through all of them?

(Gustavo Ceinos):No.  You need to call the non-voting representatives.

(Faith Newton):Okay.  Thank you.  Non-voting liaison stations.  (Leah Williams).

(Leah Williams):Here.

(Faith Newton):(Courtney Miller)?

(Courtney Miller):Here.

(Faith Newton):And Ben HsuBorger?

Ben HsuBorger:Here.

(Gustavo Ceinos):Thank you.

(Faith Newton):Thank you.

(Gustavo Ceinos):Thank you, (Faith).

(Faith Newton):You're welcome.

(Gustavo Ceinos):I want to mention a few changes to the agenda.  At 9:45 today CDC has been replaced with NIH.  So NIH will go at 9:45.  And CDC will go at 9:20 tomorrow.

Also we have (Matt Reinhart) from the Department of Veteran Affairs.  He will be just for this meeting.  He will be presenting instead of (Drew Helmer).  And from the Health Resources and Service Administration we have identified an ex officio.  However, she cannot attend this meeting.  And we have instead just for this meeting (Jennifer Hoffman).  So those are the only changes we have to the agenda.


Now I'd like to introduce Admiral (Giroir).  He will open the meeting.  And he is the Assistant Secretary for Health here at HSS.  He is the Principle Public Health and Science Advisor and he oversees the Department Grow Ranging Public Health Offices which missions include HIV policy, women's health, seeks prevention and human resource protection.

He oversees the Office of the Surgeon General and the US Public Health Service Commission Core as well as a number of key (unintelligible) advisory committee such as this one (unintelligible).

Admiral (Giroir) received a Bachelor's degree in Biology from Harvard University and a medical degree from the University of Texas Southwestern Medical Center.


(Brett Giroir):Good morning.  And thank you, Commander (Ceinos) for your introduction.  And I'd like to thank everyone on the Chronic Fatigue Syndrome Advisory Committee for your presence, your dedication and for having me here today.  This is the first time we've been able to interact.

I was sworn in as the Assistant Secretary for Health -- better known as the ASH -- in February.  And it's been a very exciting time here.  As Commander has said my role as the Principle Public Health and Science Advisor to the Secretary and in our office, we have very broad ranging office responsibilities including many programs -- minority health, women's health, adolescent health, disease prevention health promotion.

Very much supported by many presidential and secretary advisory committees of which you are one.  Your role is really critically important because we need the outside input, the outside expertise, the outside perspective in order to best attack the issues that are the subject of the advisory committees.  So what you say really does matter.  I read it.  I get briefed on it.  The Secretary reads it and we definitely work to develop and orient our programs and policies heavily dependent on the input which you provide.

One of the things that I would like to introduce is there are many important concepts to the office.  I like to talk about nine words that I hope describes our view in all things.  And that is health for all, health by all and health in all.  These are nine words that I hope will guide my office's function and I hope you keep in mind in this advisory committee.

Health for all what I mean specifically by that is that's our aim, the aim of office that everyone in this station has a fair and realistic opportunity to optimism their health.

Health by all is a principle that I believe that the focus of health should be far beyond the formal health care system but it really should be health care distribution.  We just need to distribute the knowledge, the capabilities so every individual, every family, every community can best take care of their own health.  By the time you get to a critical care unit or a critical care physician it's far too late.  We really want to empower individuals to care for themselves, improve their health, improve the health of their families.

And health in all what I mean by that is we should prioritize health considerations in all sectors and in all policy areas that just doesn't stop at health and human services.  One might image that if we're building infrastructure in the community the ability to have places for safe play, walkways, playgrounds, community centers are all very important to the overall health of our individuals and our communities.  When we talk about housing, food security, these are all things that are all very important to health.

So my thoughts certainly is to have prevention and health promotion above all and to take care of illnesses, sicknesses, maladies as early as possible so that we can all enjoy a high quality of life.

I really enjoyed looking at today's agenda because I see that there are very important conversations and discussions.  I'm also very pleased because I am a critical physician but a pediatric critical care physician.  So I'm particularly pleased that there is a focus on children's health news.  Children are one of the groups that are often forgotten in our health care discussions and certainly the last to get needed treatment approvals throughout the processes.  So I'm particularly pleased and want to congratulate those who organized.

As the Assistant Secretary of Health -- the ASH -- one of my important roles is to bring people together, to convene a cross health and human services which is an 80,000 person $1.2 trillion agency.  And so I really am very pleased today that we will have many interagencies partnerships and interagencies input including the Department of Veterans Affairs, Defense, Education, and Social Security Administration.

I also believe that health -- and this is certainly true -- is a team sport that can't be solved just by government organizations.  We absolutely must work with non-federal organizations, non-profit organizations, professional organizations and particularly organizations that represent the patient in the care provider communities because you certainly have the most important perspective on the problem that of the patient, the patient's family and the care providers.  And what you bring is really a fresh and honest perspective to a process into a discussion that we all really need.

So again I want to thank everyone for having me here.  I want to thank you for your dedication.  I want to thank you for your commitment to this committee and the people whom this committee will affect.  And you certainly have my full support and everyone here knows that if I can do anything to support the functions or the deliberations of this committee, I'm here to serve.

So with that being said, I'd like to turn over discussion now to Ms. (Nicole Greene) who's the Acting Director of the Office of Women's Health.  With her strong support and direction, the Office of Women Health provides the administrative support for this committee really which makes this committee happen.

So welcome.

(Nicole Greene):Thank you, Dr. (Giroir).  And good morning everyone.  Like Dr. (Giroir) I'm also really glad to welcome you here today for this CFSAC staff meeting.

I would like to provide you with a quick update on the CFSAC Charter which currently expires in September.  As you know when the charter was last renewed in 2016, we added two additional voting members.  One in patient (unintelligible) and another in the health care delivery patient health care services for volunteer voluntary organizations category.  This created a total of 13 voting members.

The charter also added two ex officio members from the Department of Veterans Affairs and the Department of Defense.  I am happy to report that as of this meeting, we have fulfilled that change and now have ex officio members from both departments.

We had a different time identifying ex officio member from the Department of Defense but during the December meeting as (Gustavo) promised you we do have someone from the Department of Defense and he delivered on that promise.  I would like to welcome Lieutenant Colonel (Tracy) to this first meeting. Lieutenant Colonel (Tracy) will be serving as the ex officio member from the Department of Defense.

We have already started the process to consider the charter status and we'll finalize that as soon as possible.  We are aware of two standing committee recommendations.  One is to include the Department of Education as an ex officio.  And two is to clearly define how many members are required to meet (unintelligible) for the committee to hold its meetings.

This morning (Gustavo) will give you an update on the status of the process to fill the six current vacancies on the committee.  In March we posted a federal register notice to fill these last remaining vacancies and I am happy to report that we received a number of applicants.  My office is committed to keeping this process moving.

Again, I welcome you today and I look forward to a productive meeting over the next two days.  And now I would like to welcome the Chair Dr. (Faith Newton) to begin to begin the committee business.

(Faith Newton):Thank you, (Nicole).  I appreciate the update.  My comments are going to be that we had five 30 members involved in the committee and three non-voting members as well as the all the ex officios.  And I have to say that I've been impressed with the amount of work that has been between January and early June or mid-June.

So what I'd like to do is get started because we got a lot of information over the next two days.  And our first presentation is going to actually our first thing that we're going to do is approve the minutes from the last staff meeting.  And we'll do with Robert's Rules of Order.  So do I have a motion to approve the minutes from one of the members?

(Gustavo Ceinos):And I would like to add that I received the changes from the members who e-mailed me directly so including (Terri Wilder).

(Faith Newton): Okay.  What we normally do is have a motion to approve the minutes then we have an option for discussion where we would actually say there needs to be changed.  (Donna) is also going to have a comment about somethings and then we make those changes and then we approve them.

So do I have a motion to approve the minutes?

(Amrit Shahzad):Yes.

(Faith Newton):Who is that speaking?

(Amrit Shahzad):(Amrit).

(Faith Newton):Okay.  (Amrit).

Any discussion?  Go ahead, (Gustavo).  What needs to be changed?

(Gustavo Ceinos):Well, give me a second.  I'm sorry.

(Faith Newton):It's fine.  It doesn't have to be specific.  Who sent it in that wants the adjustment?

(Gustavo Ceinos):(Terri Wilder).  (Terri), do you have can you speak to your change?  Not (Terri).  I'm sorry.

(Faith Newton):(Donna).

(Donna Pearson):There's something my understanding was that we were going to bring them up today so I didn't e-mail you.  But I just wanted to ask that one sentence that is correct be removed.

(Faith Newton):And what is that sentence?  Go ahead.

(Donna Pearson):The sentence is Ms. (Pearson) clarified that that the patient care giver position does not require that the candidate be a direct caregiver.  The person needs experience related to assisting patients or volunteering.  That sentence should be removed.  That is an incorrect summary of what I said.

(Faith Newton):Okay.

(Donna Pearson):It would be just easier to remove it completely.

(Faith Newton):That's fine.  So we will change the minutes based on what you said.  Any other comments?  Go ahead.

(Donna Pearson):The second thing was I don't remember the details.  I just remember that we discussed putting together a recommendation to ask the Surgeon General to do a letter similar to what was done in New York.  I vaguely recall maybe making the suggestion that perhaps (Cindy)’s Group of the Medical Education Work Group could tackle that at some point.  I don't know that she agreed to that and I don't believe that it was assigned but no action was reflected in the minutes.  So I'm not sure that it needs to be.  But maybe we can bring it up again today if not.

(Faith Newton):Yes.  I don't believe we voted on that and approved it.  But I would have to go back and look my notes.

(Gustavo Ceinos):That recommendation wasn't voted upon and approved otherwise it would have been included.  And it was not discussed with the Medical Work Group.

(Donna Pearson):I think we all said yes, we think it should be done.  But we never assigned it.  So I think maybe that's just an unfinished item that maybe (Faith) can bring up again at some point.

(Faith Newton):If we have time, yes.  If we have time, we can bring it up for this session.  We've got a lot of stuff to cover.

(Gustavo Ceinos):And, (Faith).

(Faith Newtown):(Donna), keep it on your list.  Okay?

(Gustavo Ceinos):(Faith).

(Donna Pearson):I'm not asking that we do a recommendation today.  I'm just asking that somebody take it on for the next meeting.

(Faith Newton):Oh, for the next meeting.  Okay.  That makes sense.

(Donna Pearson):All right.

(Gustavo Ceinos):(Faith), and I found the e-mail from (Terry).  And I know (Ben) is here representing (unintelligible).

(Faith Newton):Okay.  That's right.

(Gustavo Ceinos):Her comment is that Ms. (Wilder) noted that one of the recommendations from the Medical Education Group is to fund an escrow a talent mentoring program to build (unintelligible) for treating (unintelligible).  The New York Department of Health (unintelligible) who treats Hepatitis C.  And she noted that that Hepatitis needs to be changed to HIV.  So that is the change.

(Faith Newton):Thank you.  I'll send apologies to (unintelligible) and (Terri) twice now.

Man:No worries.

(Faith Newton):Okay.

Woman:I have a comment.

(Faith Newton):Go ahead.

Woman:On the description of the Medical Working Group, it says (unintelligible) ME and MF, if you could insert Massachusetts.

(Faith Newton):Thank you.  Any other comments about the main meeting minutes?

(Gustavo Ceinos):And I will add the (unintelligible) ask all the members to please e-mail their change to make sure it is effective.

(Faith Newton):All right.  All in favor say Aye.


(Faith Newton):Anyone opposed.  The minutes are so approved.  (Gustavo), you're next on the agenda.  And we are actually ahead of time.  Based on implementation and recommendations to the Alaska staff meeting.

(Gustavo Ceinos):Okay.  Here we go...

(Faith Newton):Let me remind everyone just make sure your phone is on mute.  And if you're going to ask questions during the conversation, please identify yourself at the beginning.

(Gustavo Ceinos):Okay.  This Thursday I want to make sure and clarify to the members that as far as these recommendations are applicable to (unintelligible).  I have add all the (unintelligible) to update the committee on their recommendations in regard to their agencies.  So the three recommendations that I'm going to talk about are the ones that apply to OPHS and they must be administrated.  The first one is continued school health and pediatric MECSF Educational Initiative.  It's recommended during the January 20, 2017 in persons at that meeting.  This recommendation is still effective.

The Pediatric Work Group has continued to meet.  And the last meeting was actually held in May of 2018.  (Faith) as the Chair of that committee will provide an update.  Any questions?  And this work group -- (Faith), correct me if I'm wrong -- will continue in 2018.

(Faith Newton):That is correct.

(Gustavo Ceinos):There's a lot of work to be done with the Department of Education.  The second recommendation is (unintelligible) Association of (unintelligible) proposal for changes to the International Clarification of Disease Pain Clinic on what is the case of coding for MECSF.  I have been in contact with (Donna Tacket) as all of you know especially those member of the Medical Education Work Group.  And they're working on the best approach to address this recommendation.

I like to point out that the National Center for (unintelligible) from CDC is not the sole US agency to make this change.  They have to work with WHO and all the stakeholders in order to make to make the changes that the committee is asking.  I try to have CDC National Center for (unintelligible) but I was not successful.  I know you guys have been asking to have somebody to come in and explain the process.  The process was explained to the Medical Education Work.  (Cindy Pavement) will cover that in her presentation or at least part of what was discussed.  Unfortunately the individuals who I invited to come to the committee could not make it.  Any questions on number two?

Let's move on to number three.  You guys recommended at the last meeting in December of last year that the CMS (unintelligible) be added back to the committee.  I have been in conversation with the previous CFSAC (unintelligible).  And if the charter is renewed, we will add him along with the Department of Education like (Nicole) mentioned in her opening statement.  Any questions?

Now I want to talk to you about the status of the filling the committee members.  As you all know if you are on our list serve which was published back in March 22 of this year, a federal register.  And the deadlines for nominations was April 23.  We received a number of applications.  After these applications were received, these applications were sent to the (unintelligible) for review.  And the deadline I gave them was May 9.  The application was reviewed and the feedback was sent back to me.  The candidates were ranked according to their experience.  And we are in the process of having these members -- let me think about -- review by the Office of the Secretary.  As you all know we only make recommendations.  The Secretary makes the final appointment to the committee.  And this is the current membership status to fix that.  You can see that we have six spacing positions.  We had to extend membership for (Faith), for (Donna), for (Alisa) and (Montoya).  Because the end date and I hope to have at the next meeting all positions filled.  Any questions?

(Leah Williams):This is (Leah Williams).  The membership is heavily weighted towards researchers once it's filled.  Will there be any discussion of that in the for the next charter?  Like maybe splitting it more equally between the three categories?

(Gustavo Ceinos):That's the way the charter was since I became the DFO this has been the way the charter - that has been the membership balance basically.

(Leah Williams):Right.  But there's an opportunity to revisit that with the new charter with the next charter?  Right.

(Faith Newton):(Leah), this is (Faith Newton) speaking.  That is something we can discuss.  Just put it on the list of things you want to talk about.  And if we don't discuss it this meeting, we can discuss it in the future.

(Leah Williams):Okay.  Great.

(Faith Newton):(Unintelligible), can you comment on that.

Woman:Just say the membership reflects regardless of the committee, the membership reflects the mission and objectives of the committee.

(Faith Newton):And that makes sense to me.

(Gustavo Ceinos):And I would have to find out from the Chief Management Officer for OS but I'm not sure if this is a discussion that needs to be had with both the Admiral and the Secretary.

(Faith Newton):And I'm not saying that I would agree with it because frankly we need the research.  We need to look - treatment right now for me is a priority and so I don't even I don't know.  It's obviously, (Leah), everything is up for discussion.  We would have to discuss what we're we would have to think about what we're doing and the purpose behind it.

Go ahead.

(Courtney Miller):Can I ask a different question?  This is (Courtney).

(Gustavo Ceinos):Yes.  Go ahead, (Courtney).

(Courtney Miller):Okay so we're hopeful by the next meeting that the ones you solicited for the position you solicited for will be filled and then we have four more people whose terms expire.  So is there an option here to solicit for those terms while we're - it might be complicated.  We're still going to be down four members at the next meeting.

(Gustavo Ceinos):Yes.

(Courtney Miller):So when does that (unintelligible) process start?  And then how will those who've applied - when will those who applied this time know that they have the position?

(Gustavo Ceinos):The nominees will receive back in the Spring will fill the six vacant positions.  We could use the rest of those nominees that were ranked high by the (unintelligible) to fulfill (unintelligible) and (Donna) and (Alisa) and Dr. (Montoya)’s slot.  So at the next meeting we might have a complete different a different committee with all new members and then the senior members will be the ones that we just came in at the last meeting -- (Cindy), (Aubrey) and Dr. (Long).

Did I answer your question?

(Courtney Williams):Yes.

(Beth Collins Sharp):So if I can interrupt a second.  This is (Beth Collins Sharp).  The Federal Register notice was written requesting nominations of people to fill up the committee.  We did not specify that it was a particular slot.  So there's flexibility in filling any slots that we have with the members or potential members nominations.

(Donna Pearson):            It's (Donna).  (Unintelligible) year.  I have no objection to you filling my position.  I am not on for the December meeting.  I think my belief is that the goal was to stagger the new membership so the concept was so that you wouldn't have a completely new group.  You have some a few people who know how, you know, the ropes.  And then by the next meeting then you could turn it over.  Again, I am not adverse to you guys having me gone and having a new person in.  But I think that was the point of doing staggered terms.

(Faith Newton):This is (Faith Newton).  Let me comment for a minute.  (Gustavo) and (Beth) have they make the recommendations up to the Assistant Secretary, et. cetera.  They don't have to solve the process after it leaves them.  So they have to wait.  And I know that they've spent quite a bit of time to see if they can get those (unintelligible) back.  So it is out of their control.  And I want to make sure that everyone understand that.

(Cindy Bateman):This is (Cindy Bateman).  Is it possible to renew terms of existing members?

(Gustavo Ceinos):We already did that, (Cindy).  (Faith), (Alisa) and basically the four on top from (Faith) to (Jose Montoya), their membership was extended six months.  They cannot be extended again.

(Cindy Bateman):Okay.  Thank you.

(Courtney Miller):This is (Courtney).  Just one more comment.  The Federal Register does specifically identify six positions that you're soliciting for.  I would love to be able to fill out the committee in one swoop here.  But just you guys figure out how to move that process as quickly as possible if it's not the same bed of submissions for this round?

(Gustavo Ceinos):We rank --as I said earlier -- we rank the applications.  We send it forward.  Once it leaves this office and goes to the Office of the Secretary -- honestly and I have mentioned I have said this before a number of times -- it is really beyond our control.

(Courtney Miller):But to be clear, (Gustavo) what is within your control is how many you select.  Right?

(Gustavo Ceinos):Yes.  And I can only select how many vacant positions there are.

(Courtney Miller):Right.  Got you.

(Faith Newton):Okay.  Let's move on.  This is (Faith).

(Gustavo Ceinos):Okay.  Sorry.  Let me get myself again here.  So we have NIH.  (Vicky).

There's a change in the agenda.

(Faith Newton):(Vicky)’s in listen only mode.  I just got an e-mail from here.  I just sent in the correct information.  I don't know if she's made it into the right group yet.

(Gustavo Ceinos):Okay.

(Faith Newton):So, (Julie), can you promote (Vicky).

Coordinator:     (Melvin) is our host.  And I don't know which line she is.

(Faith Newton):Okay.

Coordinator:     And she can hit star 0.

(Gustavo Ceinos):(Vicky), if you're on the line, can you please press star 0 so the operator can open up your line?

Coordinator:     (Vicky) has joined you.

(Gustavo Ceinos):Hi, (Vicky).

(Vicky Whittemore):       Hi.  This is (Vicky).  I apologize.  I never received the other number so I apologize.

(Gustavo Ceinos):Go ahead.  You have the floor.

(Vicky Whittemore):       Thank you.  And good morning everyone.  It's my pleasure to present an update for all of you on the activities of the National Institute of Health.

Do I just request next slide?  Is that how?

(Faith Newton):Yes.

(Gustavo Ceinos):Yes, ma'am.

(Vicky Whittemore):       Okay.  Next slide, please.  So from this graph you can see the funding levels for research on MECFS funded across of NIH from fiscal 2012 through fiscal year 17.  And you can see there has been a study increase and then a much more significant (unintelligible).  Fiscal year 16 and 17 where we went from a total funding of 8 million in fiscal year 16 to 15 million in fiscal year 17.  There are some new grant applications investigator initiated applications in fiscal year 17.  But the majority of that funding is funding that's supporting our new collaborative centers and the date of management and coordinating center.  Next slide please.

So if you look across the NIH Institute you can see that there are now several institutes that are funding.  So in fiscal year 16 we just had five institutes that were supporting research on MECFS.  And with support from many different institutes primarily again to help support the collaborative centers and the data management coordinating center.  We've been able to pull in funding from additional institutes at the National Institutes of Health.  Next slide please.

So just briefly to remind you of the collaborative centers.  We've funded three collaborative centers.  One the PI is (Maureen Hanson) at Cornell with her team.  Another center at Columbia with (Ian Lipkin) as the PI.  And the third at Jackson Laboratories in Farmington, Connecticut where (Dorian Ukamass) is the PI.  And also -- excuse me -- the Data Coordinating Center which is located at Research Triangle Institute in North Carolina where (Rick Williams) is the PI.  And the next slide please.

So each center is carrying out - so these centers were funded towards the end of September 2017.  So they'll still within the first year of their funding.  And they are each carrying their own research projects related primarily to basic mechanisms of MECSF.

So Cornell is focused on identifying biological mechanisms and testing the role of genes inflammation and immune system.  And they are also using an exercise induced challenge to really be able to look at the impact of post exertion and (unintelligible) on many of these factors as well.

At Columbia, they're using an existing collection of samples that were taken from individuals with MECFS and looking for microbe agents that may play a role in the disease as well as doing comprehensive genetic analyses.

And then the last center is the topological mapping of the immune metabolomic and clinical (unintelligible) that's being carried out at Jackson Laboratories together with their collaborators including (Cindy Bateman) who is a collaborator and a clinical recruiting site for that center.

In addition each of the centers was required to put have set aside money that they would utilize for a collaborative project which is just being in place now and will be initiated in the next couple of months.

And also the Canadian Institute for Health Research has now issued an RFA to support a center in Canada that would also work in collaboration with the other United States based collaborative centers.  So we're looking forward to that collaboration.  Hopefully initiating this fall.  And then the next slide.

So recently at the NINDS Advisory Council Meeting, Dr. (Koroshetz) announced that NIH is going to put in place a working group of council and this working group will be chaired by (Steve Roberds) who is the Chief Scientific Officer at the Tuberous Sclerosis Alliance and a member of the NINDS Advisory Council.  He is a neuroscientist and pharmacologist by training but works very closely as the Chief Scientific Officer with patient advocates in the Tuberous Sclerosis Alliance.  And I think will be a very excellent Chair for this working group.

Additional members will be invited very soon by Dr. (Koroshetz).  And the goal of this working group is really to provide scientific guidance and recommendations to the NINDS Advisory Council, Dr. (Koroshetz) and the Trans NIH MECFS working group on how the advanced research on MECFS.  So more information will be posted about this working group and our timeline for activities on the NIH MECFS website in the very near future.  And the next slide, please.

One of the projects that we recently wrapped in collaboration with the CDC are the Common Data Elements program for an initiative for MECFS.  And if I could have the next slide.

So what are Common Data Elements?  Common Data Elements are it's a project that was initiated within NINDS many years ago through a contract to develop data standards for funded clinical research and neuroscience.  And as I said we recently partnered with the CDC who provided co-funding for this initiative to really develop content standards that can be applied to data collection and across all studies in MECFS.

And so the idea here is not to dictate that you have to do these studies but if you do a particular study here is how we would like you to report out the data elements and the outcomes of the analysis such that information and data can be compared and analyzed across different studies.  And this clearly has been quite a difficult issue within the MECFS community where the standards have not been in place in the past where makes it very difficult to compare results across studies.  So it's the CBE are not a data base.  So it's just data standard, sort of a data dictionary and a way to report the outcomes.  And if I could have the next slide, please.

So the objectives are that these CDEs would be used in clinical research and they would present as I said a data standard in a standard format for reporting across all studies.  They identify common definitions, they help to standardize the clinical reporting forms or CRF when needed and provide information to researchers for clinical data collection and sharing.  And the next slide.

So the methods and timelines we used for this project was set in -well, actually we first announced that we were going to initiate this project at the IACFS Conference in October of 2016.  And then in December we invited researchers, clinicians and patient advocates to participate in the working groups.  The working groups were divided into eleven subgroups and I'll discuss that in a moment.  And then their work began to really focus on development, identification of instruments and data elements within each of the domains each working group or each subgroup covered.

And then between October and December, there was internal review across all the working groups of the work that had been done in December and then through January of 2018 the Common Data Elements were posted for public review and we received a lot of really excellent comments from the community.  And in February the posting of the MECFS Common Data Elements were posted on the NINDS Common Data Element website.  The review and the revision of the Common Data Elements is an ongoing process.

So there is an oversight committee for all of the Common Data Elements developed by NINDS which will now include numbers from the MECFS community and as needed the Common Data Elements will be updated and revised.  There is also a publication committee that is working now to put together a scientific publication that will describe the process that was used to develop the Common Data Elements as well as then to summarize the outcomes.  And then the next slide, please.

These are the domains that the Common Data Elements covered.  So everything from base line information which are simple things like gender, age and those sort of demographics through fatigue, post exertional (unintelligible) and all the way through biomarkers and pediatrics.  And the next slide.

So in each subgroup once they had identified the common data elements, they were then classified into one of these categories.  So general or core Common Data Elements are things that should be collected in every study.  And again those are primarily demographic types of information that are collected from all study participants.  Then there are diseased core Common Data Elements that are things that are specific to MECFS that should be collected.

And then you supplemental highly recommended, supplemental and exploratory which are all things that are Common Data Elements that may be utilized in particular studies depending on the protocol and the objectives on the studies.  So for example some studies may collect information on post exertional malaise or fatigue where another study that's not looking at that might collect very different Common Data Elements.  And signs of things fall into those three categories.  And the next slide, please.

So this is a special shout out and thanks to all of the individuals who helped with this process.  (Beth Unger) and I were the project leads and we worked together with (Andrew Brieden) and NINDS and the staff and the NINDS Division of Clinical Research that oversees the contact to (unintelligible).  And I think one thing I would comment on at this point is that this is the first time in the development of disease specific Common Data Elements that individuals with the disease or advocates have been actually part of the process.

And it was actually I think a really wonderful experience and hopefully the patients and advocates feel that way as well but I think they brought a different and very important level of discussion to each of those subgroups and really provided important input that had not been included in those early discussions in the past.  So special thank you to them and also to everyone who participated in this process.  And the next slide, please.

So if you would like to access information about the Common Data Elements, you can go to the NINDS Common Data Elements website.  For more information specifically about the Common Data Elements, you can contact me and that's my e-mail address at NIH or the NIH contractors and that is their e-mail address.  And in general for more information about MECFS and NIH activities, you can go to the NIH website.  And that URL is on the slide there at the very bottom.  And the next slide, please.

And I'll end with the announcement that and ask you to save the date.  We're organizing a conference together with in partnership with solve MECFS initiative.  And we're hoping to bring along other partners in the community to help put this endeavor that this will be a two day scientific conference that will be held on the NIH campus and so we ask you to save the date and, again, we'll be getting information out about this conference in the very near future.

And with that, I will end my comments and thank you all for your attention and for allowing me to provide this update today.

(Faith Newton):(Vicky), it's (Faith Newton).  Thank you very much for an excellent presentation.  Comments from the committee members?

(Donna Pearson):This is (Donna Pearson).  Can I ask a question?

(Faith Newton):Go ahead, (Donna).

(Donna Pearson):Thanks, (Vicky).  That was great.  With the Common Data Elements in place, is now a good time I hope for the (unintelligible) or maybe (Walter Koroshetz) or whoever to request specific and significant funding from monies available either at Dr. (Collins) or other leader's discretion in order to truly and quickly ramp up research using target R Phase which is something that we recommended repeatedly through the years.

We know that there have been of billions of dollars being added to the NIH budget.  And all we're looking for at this point is a measly $250,000 which in other fields is nothing.  For it's us, it's just holding this field back that we cannot get the funding that we need to get this disease recognized.  And I do know that all the recent reports have stressed the urgent need -- urgent is repeated over and over again -- for research and treatments.  You know if you fund it, they will come.  So how do we fund this?

(Vicky Whittemore):       No.  Thank you for the question, (Donna).  And this is, you know, we have really been concerned because the grant applications are just not coming in to NIH.  And as I've said in the past we can't fund grant applications that don't come in.  And any investigator can submit a grant at any time to what are called the parent announcements that are open to the entire research community to apply for funding.  The working group of NINDS council is going to be working with us over the course of the next few months to really look critically at the need.  And if we do in fact need to consider targeted RSAs.  It's I think difficult in this funding environment especially when we don't receive an actual budget until more than halfway through a fiscal year to plan initiatives.  But I think this I take your comment seriously and it's something that we will be addressing in the very near future.

(Donna Pearson):That is great.  I know that we had a R phase several years ago and the applications came in.  We know that we just did for the centers.  And the applications came in.  And in order to attract new, you know, researchers, I think the money has to be there.  I don't think that they want to spend their applying for grants when they don't think that the money is going to be there.  So I do I stress the need for the R Phase.  I think that is so important.

(Leah Williams):I have a comment.

(Vicky   Whittemore):     Can I respond to that please?

(Leah Williams):Yes.  Sure.

(Vicky   Whittemore):     To be clear any grant that comes in and gets a good score will be funded.

(Donna Pearson):We know that.

(Vicky   Whittemore):     And it's the same with an RSA.  We're not going to fund at a different level through an RSA than we do through an investigator initiated grants.  So I think it's a misperception in the community that you have to have an RSA in order to be funded.  And that's something that we really need to work with the community on.  Because if we had ten excellent grants that came in and scored well in the next round, we would fund the ten excellent grants.  It's not that the money isn't there.  So, you know, it's a...

(Donna Pearson):Because my understanding is that the RSA makes it known to the research community that you intend to award money to someone to get this research done.  Is that true?

(Vicky   Whittemore):     If we had a RSA -- and I'm not saying this would happen -- if we had an RSA and all the grants that came in scored so poorly that they didn't warrant being funded, we would not fund anything.  So even if we have a RSA or an just a regular investigator initiated grants through the peer review system, they have to be meritorious and score well in order for NIH to fund them.  We're not going to fund research that the reviewers do not see as being meritorious.

(Donna Pearson):Again, I don't want to beat a dead horse but this is really important.  We've heard that only a small percentage of, you know, grant applications get funded.  Is there a higher percentage when there's a RSA?  I mean do you end up with 90% RSAs funded because only 10% don't have enough good applications?  It seems to me that the RSAs are much more likely to get funded than just the average grant application.

(Vicky   Whittemore):     That's actually not true.  Again, in a RSA we look at the scores and the scores that get funded through an RSA are comparable to the scores that get funded through the regular investigated initiated path.  So that may be an exception in particular cases and depending on the funding available.  But that's typically not true with a RSA that's a pretty general call for disease specific research.

(Leah Williams):May I make my comment?  This is (Leah Williams).

(Vicky   Whittemore):     Sure.

(Faith Newton):Go ahead, (Leah).

(Leah Williams):Yes.  So I am a PhD research scientist.  I write proposals to federal agencies all the time.  And I can tell you that I don't put the time and effort into writing a proposal if there isn't a RSA that I'm responsive to.  So I think if you have a RSA specifically for this disease, you would encourage a lot of people to write really good proposals.  And you would find plenty of proposals to fund.  But the tradition or the history has been that NIH doesn't fund proposals about MECFS and so nobody's going to write them because it really takes an enormous amount of time and effort to write a proposal.  So I would second (Donna)’s request.  NIH consider a targeted a RSA.

(Vicky   Whittemore):     And I appreciate your comment.  I'm a former NIH funded researcher myself.  So I appreciate the time and effort.  But it's just not I mean I truly do understand your points.  So please don't take this wrong.  But we cannot have disease specific RSAs for every neurological disease or every disease that NIH covers and that is why we have the parent grants.  And what NIH did in terms of funding in the past I think is a moot point.  We're in 2018.  And we are doing everything we can to encourage applications to come in and the meritorious grants will be funded.

(Donna Pearson):You said you would be considering this in the next few months, (unintelligible).  Because I think you're doing everything you can except doing the RSAs which pretty much everyone in the communities thinks is what is needed and certainly what has been recommended by this committee and also because of the government reports themselves are all saying funded.  It's urgent.  Not all the other diseases are urgent.  I think there's an argument to be made here to get these RSAs.

Thanks, (Vicky).

(Vicky   Whittemore):     Thanks, (Donna).  I appreciate your comments.

(Faith Newton):Any other comments from members of the committee.  This is (Faith).

(Benji Border):This is (Benji Border) with Any Action.  I just one comment for (Vicky).  A question really.  One thank you for all the work you are doing and have continued to do for this group.  I guess one question I have going back to how do we, you know, you talked about the Common Data Element and, you know, that's certainly needed important work.  But, you know, moving out a little like there's still the question how do we select patients.

And I'm wondering if there's anything that NIH can do to, you know, put together a census meeting of disease experts to start to agree on patient selection.  Because if we don't, you know, now this issue of patient selection that's going to impact all the research we want to do.  And, you know, Common Data Elements go so far but it doesn't it doesn't fully address the issue of how we're making sure that we're studying the right patient and how we define things like PM and measure it.  So would it be possible to have a for NIH to organize the census meeting of disease experts to hammer out this issue of patient selection?

(Vicky   Whittemore):     So thank you for the question.  Yes.  And I think, you know, I do agree that it's a critical issue.  And again something that we will be looking at in the coming months.  And I think that one thing we have to come in mind is that each protocol may be slightly different in terms of the population of individuals at MECFS are recruiting.  But having said that I think it will be critical to really have common recruitment eligibility criteria.  So who is being recruited for given studies?  So I think, yes, thank you.  And that's something that we will be considering in the coming months.

(Benji Border):Thanks, (Vicky).  And just one more question and I won't belabor it now.  But as I'm sure you're aware Any Action has submitted a letter to (Francis), Director (Francis Collins) about the issue of ME and ways that (unintelligible) can take leadership and do more on the (unintelligible).  We submitted that back in May on May 22 and have sent several inquiries.  Haven't received a response yet.  I was just wondering if you know anything if you're aware of any response yet.  Just wanted to ask.

(Vicky   Whittemore):     Yes.  So I have seen the draft of the response.  And it's working its way through the process.  So you will be receiving a response soon I believe.  I think it's now back in the office of the Director for their final approval before being sent.  So that should be coming back to you very soon.

(Benji Border):Thank you.

(Faith Newton):Any other comments?

(Courtney Miller):Yes.  (Faith), this is (Courtney).  (Courtney Miller).  (Vicky), I want to restate something I've said in a previous meeting and then follow along with the comments that have just been made.

Your presentation is reflective of a lot of step ups in the amount of work that NIH is doing on our disease.  It's a dramatic change from, you know, for three, four, five years ago.  So I do want to recognize that shift.

I also want to echo what's been said before that we need to do that multiple times over at NIH.  We also need to do it in all of the other agencies that participate in (unintelligible) and are part of HHS.  And I would even argue we need to do it at HHS itself and come up with other ground breaking initiatives that change the game for people with ME with respect to NIH I think your own presentation reflects the fact that if you put a RSA out as you put something out you will get qualified and new investigators, grants fundable.

Your efforts in the last year and a half have doubled the amount of funding from a few years ago.  But we need to do that multiple times over and I think very credible arguments can be made for RSAs defining subsets, defining patient selection, defining patient outcomes for treatment trials, identifying diagnostic or better for the next generation ways of diagnosing the disease.  There's a long list and a great need.

And so as you consult with the advisory board you're putting together, (unintelligible) Working Group, and there is funding and there is - there's need and there's the science to emulate the next set of work.  I wanted one specific thing I wanted to raise and we'll talk more about treatments from the Treatment Trials Working Group.  But whether there was a potential to consider the supplemental grants that you issued one of your initiatives over the last couple of years was to allow existing grants to add a supplement to include any CFS in a study.

I'm wondering if that's possible in the world of treatments.  Will they consider that?  I think that's my question.

(Vicky   Whittemore):     Right.  So administrative supplements are available to any NIH funded investigator at any time.  The notice that we put out for administrative supplement specific to MECFS is because we did have some funding that we needed to spend specifically on MECFS in sort of a quick way which was what lead to that notice for supplements.  But any as I said any administrative supplements are available at any time.  And any investigator who's interested in submitting a supplement of any size should contact their program officer to have that discussion.

(Courtney Miller):Okay.

(Faith Newton);This is (Faith).  Thank you, (Vicky), for the work she's done in the last few years.  And I agree with (Courtney) and with everyone else.  Of course we need more money.  But just doubling from 8 to 16 million, the number of people that you've brought together, all the work that you've done is commendable.  You've just done an excellent job.  And it's reflective in all the time that you've spent in the groups of people you've brought together to move the NIH and completely we working together to move us in a direction that we need to go.  And I just wanted to thank you for your time and your effort.

(Vicky   Whittemore):     Thank you, (Faith).

(Faith Newton):You're welcome, (Vicky).  The next presentation is going to be by (Michael Goldstein), updates on MECFS activities in the Social Security Administration.

(Michael Goldstein):       Thank you.  This is (Michael Goldstein) from Social Security Administration.  And with me, I have (Susan Luther) as well who may chime in today.  We appreciate the opportunity to speak to you all.

A lot of focus today is going to be responding to the (unintelligible) that we received at the December 2017 meeting.  And just give you an update on what we've been doing related to MECFS.  You can move on to the next slide.

We had a discussion last time about our CME or Continuing Medical Education Video on the MECFS.  And we found out that if you want to pursue that video that you would need to (unintelligible) for that information or for that video.  And that is because generally speaking we don't release any of the CME videos.  They are meant and produced for internal consumption and for those with background and expertise in our program knowledge.

Similarly there was a request we provided a good amount of data and information related to MECFS nationally and the rates in which we're receiving applications of the primary code for MECFS and provided information about the allowance rates and there was a request about getting that at a state specific level.  And as in the case of CME, that is something that would need to be (unintelligible).  We are a national program.  Our produced data is generally at a national level.  It's a bit of a lift to get into the state specifics of more than 50 specific reports.  So that would have to go through the (unintelligible) and be given that legal analysis as to whether that would fall under that request.

There was also a discussion about prototype space.  And we'll get into that just a little bit more.  That's not something that's specific to MECFS.  But it's a program that we have run and it applies to all cases.  It happens in certain states where - I should say most cases.  But it happens in certain states where there's some expedited measures as far as appeals and stuff.  So we just reacting and providing you with that information.  And also we'll get some of the resources used to inform our policy here with respect to MECFS.

And just a quick reminder, here we're a little bit different.  Our approach to this disorder and all this disorder is a little bit different than what you're going to hear from NIH or CDC in a sense that we really are a reactive agency.

And what I mean by that is that we're assessing individual as to whether they might receive disability benefits.  We don't encourage treatment of any kind generally speaking.  We don't tell a claimant or applicant what to do.  We're not an agency that's going to be involved in cutting edge research related to diagnostic tools and things like that.  We really have to go by common commonly accepted medical practices what's the standard in the field when we're assessing in the disability.

So I just wanted to point that out.  I think that's important to remember with respect to Social Security's approach to not just this but all disorders.  You can move ahead to the next slide.

So here are the prototype states.  Again these are states where individual what we call a single decision maker can go ahead and make the decisions.  I'm going to hand it over to (Suzanne) here who is going to speak about this for just a moment.

(Suzanne):I think the bigger thing that we heard about in terms of the prototype states in terms of the last meeting the reason it came up was that (Melissa Spencer) who had done that presentation had presented some data about the number of determinations, the number of allowances and the allowance rates at the various levels of our process -- so initial determination, reconsideration level as well as the hearings level.

And I think the reason that the prototype states came up is the biggest piece that we're concerned here is that there is not a reconsideration level in any of these states.  So some of that data that we saw then would not necessarily apply to individuals in these states because those states do not utilize the reconsideration level of a (unintelligible).

(Michael Goldstein):       Thank you, (Suzanne).  So here's a map with the prototype states and a list on the side.  We can go ahead and move on to the next slide.

We were asked for the reference materials we used to inform our policy here.  And also we touched it on last time.  Our policy - our primary policy should say the Cornerstone Prayer MECFS Policy is located in Social Security (unintelligible) 14-1P.  On the slide you can see the web address for that.  We provided Commander (Ceinos) with a list of references in response specifically from the last meeting.

We are also in the process of reviewing the SSR.  Like I said it's not necessarily based on cutting edge research but we're always looking at developments in the field.  For additional references you can go ahead and look it.  Look at it, review it and you'll see additional references in the footnotes.  You can go ahead and move on to the next slide.

So what we've been doing since the 2017 meeting and what's going on as I just mentioned, we're continuing to survey the research landscape for any updates.  Our team here (Suzanne) has been analyzing different articles and journals and research and stuff.  We consult with our medical professionals in house here and are currently looking at ways that we can update our policy related to MECFS.  We've also updated a fact sheet for medical professionals.  The medical professionals who might have - I think they're often used by medical professionals who have patience or clients who might be applying for Social Security benefits and tools we offer them in our external websites.

We updated that to reflect name updates to MECFS from the CFS and some other small updates.  We worked with the Centers for Disease Control to up their page on MECFS website as it relates to our disability program.  And again updating terminology related to the SSR revising that and we're continuing to do that today.

So again we really appreciate the opportunity to be here to discuss this with you.  We are really looking forward to all the other presentations and to see how the landscape and direction of research and where that's all headed as it continues to inspire our work here.

Move on to the last side which just invites questions.

(Faith Newton):Questions for (Michael)?

(Benji Border):This is (Benji Border) with Any Actions.  Thank you, (Michael), for being here, for this presentation.  I have to say I'm a little bit frustrated.  I look at the information that you've provided here.  And the larger context is and I'm the community organizer within a patient advocacy organization and I'm dealing every day with people who are contacting me with how the system is broken and how it's affecting their lives and how determinations within Social Security Administrations process are not reflecting the best medical knowledge, the most accurate understanding of the disease.

So, you know, when I hear you saying, well, we're not going to release how we make our stuff, how the sausage is made and we're not really inviting you in being the stakeholders into the process in trying to approve, the bottom line is we have, you know, you have things are broken in your house.  They need to be fixed.  And what you hopefully will take away from these two days of talking with the other agencies, seeing these research updates is how vast this problem is.

And so the question is downstream how this affects a reactive agency like the Social Security Administration that you cannot be compounding the problems of doctoring the education, of lack of research?  But that you can actually be bringing together those who know the most about this disease, how it impacts people s, and so when there's evaluations being done of people of whether they have this disease and if they need benefits that accurate assessments should be made and quite frankly the community a trusts the Social Security Administration is doing a good job on this is pretty low.

So, you know, I appreciate you're coming here.  We want to work collaboratively.  But I don't see you giving up a lot of way to say let's have a discussion about how we can do better and that's really just the point.  And I just really to re-emphasize to you, like, there are many people being harmed.  I'm hearing stories all the time about people who are getting assessments and judgments made that simply don't reflect the best knowledge of this disease.  And we want to help change that.  And so how can we do that?

(Michael Goldstein):       I really do appreciate the feedback.  One of the things with respect you may have been alluding to the specific CME video.  And like I said that is nothing specific to CFS.  Those are made for individuals who have program knowledge.  Our definition of disability at SSA is unique to SSA.  The entire process is complicated.  So those are not constructed for public consumption.  Like I said you can get access to them if you (unintelligible).  You very may be granted those videos.

Another point is...

(Benji Border):But then I'm asking, (Michael), sorry, I'm asking how we can - I realize you're working with concerned bureautic restraints.  But I'm saying, you know, this process is not working.  So what are creative ways that we can better work together to make sure that people have the knowledge so that people can accurately access things.

For example I know of assessments being where, you know, patients provided information.  They went to doctors and had, you know, information provided that they did not have, that this is a real organic disease.  This was not an issue of depression.  And, you know, assessments were made within were reversed by judges and officers who said, you know, because this person, you know, is having trouble in crowded spaces, that shows that they're actually depressed so it's not actually they're not actually having a biological impairment.

And that's just simply reflects an ignorance of this multi-symptom neuro-immune disease and how it works with people.  And so it's those kinds of things where people are making where there's obviously some lack of understanding about the disease.  And we want to help fix that so that people understand what it is and that better more accurate assessments are made.

(Faith Newton):(Ben), this is (Faith Newton) -- the Chair -- speaking.  (Michael), I have a question for you.  You're now on the ex officio, you with (Suzanne)’s help will be sitting on this committee.  Would you - we have working groups.  And I know you're brand new.  Would be interested as one of the ex officios -- all of ex officios sit on the working groups.  Would it be possible for you and/or (Suzanne) to sit on one of working groups?

(Michael Goldstein):       Yes.  I think that's a great idea.

(Faith Newton):Okay.

(Michael Goldstein):       Go ahead.

(Faith Newton):Go ahead.

(Michael Goldstein):       No.  I was just going to say as far as creative ways that we can work together, I think like you said personally for me this is kind of my introduction to this at this meeting right now.

(Faith Newton):Right.

(Michael Goldstein):       And I would love for other opportunities.  I think it was (Ben) from Any Action who's the initial questioner.  We would be happy to attend other forums where we can get this information.

(Faith Newton):Right.  And that's...

(Michael Goldstein):       And as far as any specific cases, I don't have (unintelligible).

(Faith Newton):Yes.  That's what I'm thinking as well.  Yes.  You're brand new and welcome to the (unintelligible).  You're welcome both you and (Suzanne).  So what I'm thinking is we're afforded a working group.  So you'll be on I'm assuming you'll be both today and tomorrow.  One of the two of you will be listening to the webinar.  So you're going to hear from the different working group.  And then I will or (Gustavo) will have a conversation with the two of you to see which working group will work best for you.  And then we'll have you on the working groups as the ex officio between now and December.  Then I think that will help move us in the right direction with having the Social Security Administration involved and we can start having conversation with, okay, so what do we need to do and how do we move forward.

(Michael Goldstein):All right.

(Faith Newton):And I think that will work a little better.

(Michael Goldstein):And some of the other tools that we use is we have some external outreach initiatives like our National Disability Forum, idea scales.  And those are things in the future when we talked that perhaps we can set something up on our end.

(Faith Newton):Right.  We need to start the conversation first.  And I think once we start having conversations and we start moving in a certain direction, I think things will fall in place.  And now that we know you're the ex officio I think that we can start moving in that direction and we can start making some headway.

Other questions?  Yes.  Go ahead.  Who is this?

(Cindy Bateman):This is (Cindy Bateman).

(Faith Newton):(Cindy), go ahead.

(Cindy Bateman):All right.  Hi.  I would like to just pose a question to you in a practical way.  I'm a clinical an expert in MECFS.  So I have many, many years of providing medical documentation.  And I've actually attended many disability hearings on behalf of my patients so and I'm from Utah.

So my question is if you're an Administrative Law Judge in, you know, Salt Lake City or someplace, how do you access or what is the, you know, how would they know about medical education?  How do they have to reach out and what is the mechanisms?  Because if we want to help with, you know, providing this type of education it would help for us to know where those points are.

(Michael Goldstein):Right.  So the cornerstone for the policy is located in that SSR.

(Suzanne):And I don't think that's just necessarily - I think in terms of the Social Security Rulings -- the SSR that we're talking about -- sorry, this is (Suzanne).  It's not just about the policy and how our adjudicators including a ALJ not necessarily how they should be looking at the case.  But we do try to provide educational information in there as well so that we're not just telling them look at these medical signs and laboratory findings.  We're trying to give them an overview of what the condition is about.  So right now I would say that's probably the primary educational field that we've had.  Because the CME is really designed for our medical components.  That is designed for people and not necessarily that staff and not necessarily other adjudicated staff.

(Michael Goldstein):       You might be more familiar but those less familiar with how our rules work.  By statute -- so this is a Congress issue and this is an act by statute by law -- we have to have objective medical evidence to move along in the disability process for favorable disability determination.  And know we have CFS is amongst a number of other disorders -- fibromyalgia comes to mind --that we've had it's a tough line to kind of cradle and straddle in a lot of these cases where we've come with these Social Security rulings to walk that fine line.  Because some of the cases don't have or would normally be considered to meet that threshold of objective and medical evidence which the laboratory findings and things like that.  So this is how we do it by way of these SSRs.

(Cindy Bateman):So let me reframe my question again.  This is (Cindy Bateman).  What are the requirements of the medical consultants to access the continuing medical education?  Is it elective or is it a requirement for them to be able to perform their consultative exams?

(Suzanne):The medical consultants that we're talking about they are not the consultative examiners.  They are not the clinicians that we might send the claimant to for more medical evidence.  The medical consultants that we're talking about are the physicians and other medical professionals who are employed either by us or the DJS.

(Michael Goldstein):A lot of times...

(Suzanne):Sometimes it's by the state to help the adjudication process.

(Cindy Bateman):Is there any requirement for the...

(Michael Goldstein):       (Unintelligible) training demands for the MCs.

(Cindy Bateman):So is there any requirement for these outside consultants who come in to support the Administrative Law Judge with their opinion?  Is there any requirement for them to do continuing education or understand about this illness that they're testifying at a hearing regarding a patient with this illness?

(Michael Goldstein):       That's a really good question and I'd have to before I try to give you an answer I'd like to look into it and see if I can come up and get you a concrete answer.

(Cindy Bateman):Okay.  Well, I'll just share with you that in all the times I've been in hearings I've never had a consultant come in and provide accurate assessment and documentation of the patient situation just because there's a crisis in medical education.  We know that.  And there are not very many clinicians who understand how to make a diagnosis and the significance of the disease.  So in the cases that I've done it's been it's really rested on me as the treating physician and as also as an expert physician to be able to provide the information to the attorney.  And if the attorney can present the case in a way that is convincing than I can outweigh those other consultants.

I'm on The I'm the Chair of our Medical Education Work Group.  It would be great if we could find out a mechanism to update the medical education of people who are, you know, rheumatologist and other people who are coming in rendering a medical opinion.

(Faith Newton):(Cindy), and these are the types of conversations we would probably have getting started in which of the four working groups he would like to have.  And yours is one of the ones that I'd be thinking that he would be a good fit for.

Do we have any other questions for members of committee?

(Christopher Tracy): Yes.  This is Dr. (Tracy) -- the DOD ex officio.  I'm a practicing rheumatologist here at Fort Brag and I recently set up rheumatology practice down here with two rheumatologists.  And, you know, chronically unexplained illnesses are something that are, you know, something we encounter a lot.  And most of the time in our rheumatology practice it's through of fibromyalgia and by army regulation they have to come through a rheumatologist to actually solidify that diagnosis before they are going into the VA system.  And this might just be because I'm unaware -- and so that's one of the reasons I'm happy to be on this committee -- is there a validated research impact questionnaire that might aid in some of these, you know, Social Security benefit problems and things?  Because I know that we have, you know, like a fibromyalgia impact questionnaire that's been, you know, somewhat validated through our research trials.

(Michael Goldstein):       Do you mean ones that would be geared towards the applicant?

(Christopher Tracy):Yes.  So this would be something that you go see a doctor and you can really take a look at the actual, you know, we do a good job in rheumatic disease of assessing disease activity when it comes to objective evidence.  But this non-objective soft kind of stuff we don't do as good of a job of and most are chronic diseases.

And so there's been this push through more of a functional analysis using things like RAPID3s, impact questionnaires, talking about, you know, true limitations of functions of everyday type of stuff to try to objectify that.  And then research it and validate it to make sure that it can be, it will be followed as far as disease activity goes.  Has there been anything done in that portion of this?

(Faith Newton):Is there anyone on the committee that can answer that question?

(Cindy Bateman):This is (Cindy Bateman).  I'll answer it to the degree that I can.  I mean that's one of the reasons the Common Data Elements project was initiated, right, to come up with some specific consistent measures.  The FIQ is one of those that we use in patients that have a significant pain component as part of their MECFS.  And really we're exploring and if you're familiar with the OIM report that the 2015 OIM report.  It's an evidence based report about our clinical diagnostic criteria.

So really the next steps are to understand how to measure cognitive impairment, how to measure post exertion malays and functional limitations.  In my clinic, I use a combination of the free version of the SF36 which is the RAM36 and the FIQ and then a few other measures.  And it is possible to document functional impairment but there's not a standard right now.

(Leah Williams):This is (Leah Williams).  May I make a comment?

(Faith Newton);Go ahead, (Leah).

(Leah Williams):So I looked up SSR 14-1P online.  And it says under medical signs to determine disability and then it has a list of symptoms none of which are the characteristic symptoms of MECFS.  So the things that it includes are tender lymph nodes, muscle tenderness, frequent viral infections.  But this does not include the characteristics of post exertional malays or overwhelming fatigue or unrefreshing sleep.

So I think this really needs to be reviewed and updated to be in line with the IOM Report for example.

(Michael Goldstein):       Some of that information is above where you are looking in the SSR.

(Leah Williams):Right.  But this section B says for the purposes of determination of disability evaluation, one or more of the following medical signs have to be clinically documented over a period of at least six consecutively months.  So if this is all that the determination is made on, it's not really appropriate.

(Michael Goldstein):       No.  I understand that.  And that's part of the difficulty is that we by law need objective medical evidence.

(Suzanne):I think one of the problems in the region that those are in there is that we are required by law we can't make a determination based on symptoms.  And PEM for example is a symptom.  Fatigue, tiredness, pain, things like that are self-reported unfortunately we cannot make a determination based on that.  And we are required to have the medical signs or laboratory evidence for things that are objectively measurable in order to make a favorable determination.  And that's what (Michael) was trying to I think say before.  It's not just objective medical evidence but we are not allowed to make a favorable determination based on symptoms along.

(Leah Williams):Right.  So (Cindy) just mentioned two different assessments that could be used -- the SF36 and the FIQ.  And there's also a DePaul Symptom Questionnaire which can be quite reliable.

(Cindy Bateman):This is (Cindy Bateman).  I would just like to say there are several, you know, several problems.  We won't be able to address all of them here.  One is that the SS -- whatever it's called -- needs to be the SSR needs to reflect the IO at the minimum the 2015 OIM criteria which used evidence base to help understand what the core symptoms are, which symptoms aren't present all the time and which symptoms are probably present in everybody.  And that's number one and I hope that's what's being done internally.


(Cindy Bateman):Number two the problem is when the rubber hits the road and we take a patient in for a hearing, they don't adhere to necessarily to SSR 14-1P because, you know, that's been there for a while.  And I've been in a number of hearings where there was plenty of evidence based on SSR 14-1P including abnormal orthostatic testing like a tilt table.  And that including an expert opinion and the cases are still denied.  So really that's a matter of educating and also calling administrative judges to task for not applying the existing criteria.

(Suzanne):I don't disagree with you on any of that.  And to answer your first question, that is what we are currently working on is updating the SSR to reflect that OIM Report.

(Faith Newton):Let's just go back - this is (Faith) again.  So the conversation is starting to get into technical details which is why I asked (Michael) and (Suzanne) if they could -- I'm sorry -- if they could get involved in one of the research committees -- our working groups -- which is where we need to go.  Because that way (Cindy), the three of you and the working group -- whichever working group he decides to join -- which he's obviously leaning towards the Medical Education one, you guys can have the technical conversations that need to be had because those conversations are extremely important.  And then we can make some headway and see what we can do.

Are there any other questions about (Ben)’s about (Michael)’s presentation?

(Donna Pearson):This is (Donna).  I just want to ask for clarification if I could.

(Faith Newton):Go ahead.

(Donna Pearson):Thank you, (Michael) and (Suzanne), for participating.  And it's great that you're willing to join working groups.  We really appreciate it.  Can you just clarify your statement about the need for a (unintelligible)?  It sounds to me like you're saying that in order for this committee to see the continuing med ed video, then perhaps the Office of Women's Health would literally have to submit a (unintelligible) to the Social Security of Administration in order to get access to that.  Is that am I understanding that correctly?

(Michael Goldstein):       Yes, you are.  Unfortunately that is our position with respect to all CME videos.

(Donna Pearson):Okay.  Thank you.

(Faith Newton):We'll ask (Gustavo) and ask to look into that first and then we'll go from there.

(Michael Goldstein):       And just one other point.  I'm looking at the pay rates at the Administrative Law Judge level.  They have fluctuated from 2017 -- now there's not a ton of CFS cases comparatively because we get a couple million applications of year -- but they have fluctuated in between about 67 and 78% are paid at the ALJ level.  So most of them are paid there.

(Cindy Bateman):But that's after 85% of them are rejected at the initial level.

(Michael Goldstein):       Right.  And those are similar - you're going to see that across the board with a lot of different impairments.

(Faith Newton):That's a conversation that also needs to be had at the Medical Educational Group.

(Donna Pearson):Until we get an objective biomarker though I mean that's very clear, we're going to be dealing with this.  I mean people with cancer or multiple sclerosis and things that everybody understands they don't go I don't think they get kicked out in that 85%.

(Faith Newton):Yes.  I agree with you, (Donna).  And I know everyone...

(Michael Goldstein):       (Unintelligible).

(Faith Newton):I know everyone on this committee agrees but what I want to see happen is I want to see the conversation start.  I would like both of them to be involved in the working group and then let's see what progress you can make.

(Gustavo Ceinos):(Faith).

(Faith Newton):Go ahead.

(Gustavo Ceinos):Finish your sentence.  I'm sorry.

(Faith Newton):And then (Gustavo) can look at whether how we get access to what we need whether it has to be (unintelligible) or not.  And that's something that they can pursue because it is between agencies and we'll go from there.

Does that make sense?

(Gustavo Ceinos):(Faith)?

(Faith Newton):Yes.

(Gustavo Ceinos):I don't see the reason why the video can be (unintelligible) by members of the committee?

(Faith Newton):Right.  I don't know either.

(Gustavo Ceinos):Because ultimately if we (unintelligible) if the Office of Women's Health (unintelligible) SSA to share that video with us, the goal is for us to share the video with the members of the committee.

(Faith Newton):Correct.

(Nicole Greene):This is (Nicole).  If SSA can't show it to you, if we (unintelligible) we still couldn't show it to you.

(Faith Newton):All right.  So we have to (unintelligible) it?

(Nicole Greene):You would have to (unintelligible) it.

(Faith Newton):Okay.  Fine.  So (Cindy) and (Sarah) of the working group will (unintelligible) it.

(Gustavo Ceinos):And as a natural item on list like last year.

(Faith Newton):Okay.

(Gustavo Ceinos):So I'm going to follow up with so of the members to with everybody who owns information to the committee.

(Faith Newton):Okay.  That works for me.  All right.

(Cindy Bateman):(Faith), I have another question if I may.  (Cindy Bateman).

(Faith Newton):Okay.  Go ahead, (Cindy).

(Cindy Bateman):Thank you again for taking the time to field all these questions.  I appreciate it and I appreciate your patience.  My question is is there a mechanism for a physician who is representing, you know, who is down in the trenches who is dealing with these things is there a mechanism for them to give feedback or, you know, send the information up to the food train if they feel like the Administrative Law Judge or that the case has been handled inappropriately.  Is there a way to give feedback at the ground level?

(Michael Goldstein):       I know I can check with the hearing's operations and see if they have anything.  I don't know that they do.  Now the denial at the Administrative Law Judge level doesn't end the process.  There's still an appeals -- the appeals council and then it could go to US District Court there.

(Cindy Bateman):I've been there and done those things.


(Cindy Bateman):That's difficult as you know and I have definitely walked through that process.  But it's the number of cases that would actually be able to get through the appeals process is pretty low.

(Michael Goldstein):       So the reporting mechanism for feedback at that level, I'd have to look into it.  There's not one that exists that I know of.  But I can look into for you.

(Cindy Bateman):That would be great.  Thank you.

(Faith Newton):Okay.  Are we all set?  This is (Faith) again.  All right.  We're a little ahead of schedule still.  (Courtney), you are up first for Presentation from Liaisons Organizations.

Wait a minute.  I'm sorry.  (Michael) and (Suzanne), thank you very much for being ex officios on Social Security.  Welcome.  We still have to do - I thought you did a very nice job fielding all of those questions.  So congratulations.

(Michael Goldstein):       Thank you for having us.  We do appreciate to be here.

(Faith Newton):You're welcome.  We are going to - we will ask you to sit on committee and get in contact with you.

The next section is Presentations from our Liaisons Organizations.  We're going to start with (Courtney Miller).

(Gustavo Ceinos):           (Courtney), just tell us when you want these slides moved.

(Courtney Miller):           Okay.  Thank you.  I'm going to go through the first few slides very quickly.  They're repetitive.  So you can go to the next slide.

So basically we're doing research as an organization is to redefine MECFS through science, identify diagnostic markers, characteristics of subsets and research that can lead to potential treatments.  And it is the research program is based on the clinical experience, very much clinically driven.  The clinical experience of Dr. Danielle Peterson.  Next slide.

Over the course of the last five years, our accomplishments include driving a strategic focus on, you know, neurological studies, publishing results, focus on sort of a specialized publications related to spinal fluid studies and their correlation with the neurological findings.

And published characteristics, so the scientific characteristics of subsets. Next slide. So as we discussed last time and earlier, the NIH centigrams are both pivotal and promising. Next slide.

And Simmaron is a (unintelligible) collaborator. And two of them, Dr. Lipkin’s Center for Solutions at Columbia and Dr. Hansen’s Center at Cornell.  And both of those centers have other collaborations. 

Simmaron has other collaborations with the investigators in both of those centers. Next slide. But I wanted to focus on today is our own priorities and the priorities for the patient community which is treatments.

It is the number one unmet need and a challenge for all of us, all of us on this committee, all of us on the disease space and for Simmaron.  Next slide please.

So there’s the promise of treatments but the treatment trials are non-existent.  So how do we change this?  In broad strokes, we tend to find responders to existing treatments. Although very hard to get there are responders to Ampligens to Cidofovir, other anti-viral to Rituxnab and I’m sure there are others and other clinical processes.

We need to train doctors to treat.  Given the experience of very few doctors on existing treatments there are protocols to share and train.  And insurance coverage would be more available.  It would be more available for patients if we had more data about these treatments and that data could lead to, you know, other approvals, other options.

And the third way we change this is we get FDA to approve the first drug for it. And it is a long and difficult process.  Next slide please. So our work as Simmaron on the treatment is to focus on data analysis. There are couple of efforts and I’m going to describe this in a picture in the next slide but don’t change the slide yet.

But the Ampligen is well used, used for more than 20 years in Dr. Peterson’s clinic. It was used in some other clinics as well.  We are hopefully about to restart a very small set of responders who’ve been off the drug for a year and as they restart, we’re going to track, Simmaron as an organization is going to track the response from a baseline through at least the first year.

We’re going to compare it to other IV treatments so other ME patients who are getting treatments like Codofovir, amino acids, IVIG saline or patients who are getting no treatments. We are going to measure some of the common data elements.

VO2max which is an exercise tolerance measure that’s more precise than time on a treadmill.  Immune markers like NK cells and other cytokines on a three month basis as well as collecting samples for more detailed research.

We are doing this in collaboration with Cornell and so they’ll be some research studies that are done on those patients in the University in the Cornell setting.

We’re also hoping and working with the CDC to do an analysis retrospectively of Ampligen patients who have been on the drug and responded. We have data.  We need to publish it so we need to go through a process of analysis.

And then a couple of us from Simmaron are working on the (Fitsac) Working Group on treatment trials.  Hope to move forward in that, in that process as well. Next slide please.

So this is a picture, sort of a modality that was provided by the clinic to show sort of what, the basics on what the particular IV medications, intravenous medications that are used in Dr. Peterson’s clinic who is the research coordinator fellow for, Simmaron.

And the comparatives for this moment where we have the ability to monitor Ampligen patients who have not been on the drug for more than a year to restart.

So it’s so, somewhat simple form and I, you know, I won’t necessarily be able to answer all the questions about this but I will attempt to, if there are any.  So IVIG has a certain set of markers or protocols.  It is effective in a subset who show immune irregularities, antibodies, high antibodies in certain measures.

And, you know, it’s used fairly commonly in a number of immune and autoimmune related diseases. It is a, we have a history, Dr. Lipkin’s clinic has a history of those data and compare it to but it’s one arm of a comparative for Ampligen restart studies.

Codofovir, antiviral for patients with recurrent Herpes viruses, infection level amino acids or patients with abnormal panels.  You can test it. It replaces something that is depleted in some subset of patients.

Saline for patients that have findings of potentially autoimmune related, it basically increases blood volume and blood pressure in patients that have trouble regulating blood pressure.

And that Ampligen based on the Canadian criteria, this group of 13 will be people who we know respond to the drug and we will have the tools to measure that response objectively, ideally we measure it biologically and do the blood and other sample studies that will demonstrate how it works.

So the data we collect from this will be housed you know, if our collaborators who want to participate, you know, we can certainly consider that and each one of these subgroups is somewhat homogenous at least with respect to whatever the indications are for that particular treatment.  The goal of is, you know, is to both identify treatments and produce data that we can publish that indicates that there are treatments out there that work for subsets of people and characterizing those subsets as important in training other clinics and physicians.

To use this more widely is, use these medications more widely is the end goal and stimulate suitable interest in the fact that this is treatable at least in subsets and there’s obviously plenty more work to do on that but we’re doing what we can to produce some of that data.  Next slide.

(Christopher Tracy):Can I ask a quick question on this slide or is it too early.

(Courtney Miller):No, go ahead.  Who is this speaking please?

(Christopher Tracy):This is (Christopher Tracy) from the (ODiagem).

(Courtney Miller):Thank you.

(Christopher Tracy):The IVIG, what’s the use of IVIG?  If they have like autoimmunity or something like that?

(Courtney Miller):Usually it’s high antibodies, possibly the autoimmune antibodies.  I’m not familiar with exactly which ones those are but you could certainly, you could call one or two people who can explain that in more detail.

If you want to email me, I will put you in touch with either Dr. Peterson or (Dunner Godsil) who is the research coordinator fellow for, Simmaron introduced this for (unintelligible) study.

(Christopher Tracy):Okay, that would be great.  Thank you.


Woman:(Courtney) or (Amrit), can you answer that question?

(Amrit Shahzad):Yes, I was hoping (Courtney) would take a stab at it.  If not, I’d be happy to take that on.


(Courtney Miller):Are you asking about what the indications are in this study or what they might be hypothetically?

(Christopher Tracy):Maybe both but hypothetically in all honesty.  You know, all the other ones look like (unintelligible). All the other ones look like there’s pay if there’s recurrent Herpes virus in that section or if you’ve got some sort of autonomic instability. This one just looks like it’s just hard to get approved so it’s not used.

(Courtney Miller):Yes, so I would say must off the cuff, I think about 25% of patients have low IDD subclasses of some type, you know, not specific, they don’t fit into a traditional diagnosis.

There’s natural killer cell function.  Abnormalities.  There’s T-cell dis-function so, and we think that patients have ill-defined or autoimmune disease we don’t have markers yet for. 

So there’s a number of reasons why IVIG is used. And there’s some hope to it I have to say, so some clinical experience that suggests it might be helpful.  But it is difficult to get it approved without meeting criteria for common variable Immunodeficiency disease.

(Donna Pearson):This is (Donna) and I actually have, I’ve been diagnosed post ME with common variable Immunodeficiency. I was getting sick constantly and fortunately my doctor knew enough to test the subsets and therefore I qualified for that and it, I do not get sick all the time anymore.

And I know that there are many other ME patients who now have common variable Immunodeficiency. We are, we patients are assuming our immune system has burned out or whatever and it developed but I don’t know whether the research knows if it’s just inherent or it is acquired.

And I think…


(Donna Pearson):…people who take this. That’s how they get qualified for it.

Woman:So last…


Woman:…could I?


Woman:Just a second.  The last speaker was (Donna Pearson).  Who is not going to speak?

(Cindy Bateman):This is (Cindy Bateman) again.

Woman:Okay, good, I just want to make sure you identify yourself for the person who’s taking notes. 

(Cindy Bateman):And that was (Donna) that just spoke just now.


(Cindy Bateman):This is (Cindy Bateman) again.  I just want to add anecdotally that early in the course of illness I’ve often used just intramuscular gamma globulin which is increasingly harder to get but it also reduces, I can just tell you from clinical experience without a clinical trial.

But really it makes it so patients don’t pick-up a lot of community acquired illness and that their, you know, their recurrent acquired infections become more in the background do they can deal with the primary causes of their illness, primary manifestations. This is something we need more research data to support.

(Amrit Shahzad):Yes, on the flipside, if I may add, you know while, and this is (Amrit Shahzad), if I may, while there is IVIGs that has been tried experimentally so it’s in the Immunoadsorption hope of removing the antibodies that are in circulation.  So there is a flipside to this as well.

(Cindy Bateman):Yes.

Woman:Any other…

(Cindy Bateman):And…

Woman:No, go ahead. Go ahead.

(Cindy Bateman):I was going to add one more point that isn’t clear on the slide for Ampligen. While the criteria and your question about the indication that suggests the use of this particular, each particular medication for is, you know, what we’re familiar with in the disease, the, I think the core findings is low natural killer cell function.

And certainly for responders that’s what we’re going to, you know, compare these in a study with certain numbers for each of these medications. But that one indication would be, include, low natural killer cell function.

And then I would then just point out that the discussion and people’s questions and the use of various medications in, you know, a handful or perhaps 10 clinics in the country merits resources to document and to shed it to the broader groups. And that is, that’s where we need to go.

It’s not the case but it’s, you know, hundreds of patients instead of hundreds of thousands have access to some things.  And we need to document it and we need to do it on a publishable basis. So next slide.

So in the other collection of studies that Simmaron is working on. I’ll just run through them really quickly.  There should be a publication of our second phase of these spinal fluid studies and we are working on a small spinal fluid study of patients, any patients who went onto develop Lymphoma.

We’re collaborating with SUNY Albany on a autoimmunity and family history study collaborating with Dr. Hansen at Cornell on her sea horse study and a number of pilot data studies, the TRMG3, allele frequencies, Mast cell activation analysis of particular tracking of Gamma Delta T-Cell rearrangement with which in this clinical practice has been used to watch for the development of Lymphoma or other blood answers.

Auto antibodies which are being associated at least with subsets and are being investigated in Germany in particular related to (unintelligible) and NESF and the  cytodines’ response to therapies.  Next slide.

(Amrit Shahzad):This is (Amrit) here by the way.  There is a lot of data that’s being gathered by the Australian researchers on the antibodies regarding against (unintelligible) diseases.  You should link in with them.


(Courtney Miller):I think we are.


(Courtney Miller):So that’s it for our presentation.

Woman:Questions for (Courtney)?  Any questions? (Courtney), very well done.

(Courtney Miller):Thank you.

Woman:Very comprehensive. You’re welcome. Next presentation will be (Leah Williams) on (unintelligible).

(Leah Williams):Hi everybody.  I’m delighted to be at this meeting and I’m going to tell you a little bit about what we’ve been working on since the last meeting in December.  Next slide please. Next slide please.  Can you hear me? Hello.

Woman:I can hear you (Leah). I can, there we go.

(Leah Williams):Thank you. So I am a non-voting liaison for the Massachusetts ME & FM Association. We’re one of the oldest and probably the most active state or local patient organizations and our mission is to improve the lives of all people affected by ME/CSF and advancing awareness, care, treatment and research.

So our work involves several different aspects. One is patient services. So we provide physician referrals for primarily Massachusetts and some in New England but also provide assistance with disability applications. And we respond to other requests for services and information.

We sponsor three in person support groups and we find those are very helpful for people.  We also a starting up a virtual support group which will be entirely online but primarily focused on people in New England.

In terms of education, (Alan Gurwit) and I presented at the Massachusetts Academy of Family Physicians annual meeting in March and we gave a talk called Practical Guidance on diagnosing and managing MECFS.

And our goal was to emphasize this is not a psychiatric illness and that (GET) and CBT are not recommended treatments because all of us have had the experience of going to a doctor and being told either we need to see a psychiatrist or just exercise, you’ll be fine.

So this was, there were about 30 or 40 family physicians in the room. They really appreciated our talk.  We got a lot of good feedback on it and I hope they will be invited back on a regular basis.  Next slide please.

In terms of advocacy, we participated in the Washington D. C advocacy day in May.  We sent two people to Washington, (Susan Buckley) and (Bob Robiti) who are both parents of ME/CFS patients.

And we participated in the SMCI lobby day on May 15 where (Susan) and (Bob) visited five offices of two Senators and three of our representatives. And then they stayed an extra day to meet with the rest of the Massachusetts delegation on May 16 so the remaining six representatives.

And we found this very effective to meet the entire Massachusetts delegation.  It was not possible to do it all in one day so we split it up over the two days Oh, you know what?  This is the old version of my presentation.

Sorry, I sent in a corrected version but somehow it didn’t get into the slides that are being presented. Okay, I will carry on. We’re very proud that Senator Ed Markey, Democrat, of Massachusetts is one of the co-sponsors of Senate Resolution 508 which was introduced on May 15 and which is a resolution in support of international ME/CFS Awareness Day.

We also participated in, sponsored a Million’s Missing event in Boston City Hall on May 12. This was supposed to be the end of my presentation but we are going to change our name hopefully by July 1 to the Massachusetts ME/CFS and FM Association.

Nobody really remembers what CFIDS stands for anymore.  And actually, that raises the question of whether CFSAC will change its name to be more in tune with current thinking about the disease. Next slide please.

We are continuing to use screenings of the documentary of the unrest as a tool to raise awareness and advocate for more research. We’ve organized six screen so far in Massachusetts and we have one more scheduled and there’s a few more under discussion.

Our typical format is to snow the film and then have a panel discussion and we try to have the panel have, I don’t know, physicians and researchers and patients to represent all the different aspects.

We had a screening at the Massachusetts Department of Public Health which was attended by about 140 Healthcare Professionals and that was very well received.  People were very interested.  It’s led to a number of contacts for other screenings.

And we had videographers volunteer their time to videotape the panel and edit it and that’s posted on You Tube, if you’re curious, we also did a screening at the Massachusetts State House where we had three Senators and three representatives attend as well as about 40 staff and interns from other offices.

And as part of organizing that, we became a co-sponsor of the Massachusetts Tele-Medicine Bill which would increase access to tele-medicine services which would be incredibly valuable for ME/CSF patients which are too sick to leave their home and get to get to a doctor’s office.

The other screenings that we’ve organized with the Regent Theatre, Wealthy College, Brandon University, Cooley Dickinson Hospital in North Hampton and we have one coming up at MGH.  Next slide please.

So one of the things that we’ve done is to get co-sponsors for these screenings and this helps us to publicize the event and send out a notice to all of their constituents on members and we found that to be very helpful.

These events help us to recruit volunteers so we have maybe 30 or 40 active volunteers now which is a factor of probably three or four more than we had a year ago. These screenings have also allowed us to make connections with local researchers and health care providers.

And we will, we hosted a researcher forum last November and we’ll host our second annual researcher forum next November at our local event and we hope to have a lot more people attend. There seems to be a lot of interest in these informal get-togethers.

I wanted to especially thank (Riska Solomon) for helping to organize all these screenings. She has done an enormous amount of work. She is an incredibly talented organizer so we really appreciate her efforts.

There have also been six screenings in Massachusetts that were not directly organized by us. We did provide speakers for two of those. And then finally, there’s a follow-on interview and video about unrest in ME/CFS that aired on our local PBS station and is also available online, if anybody wants to look it up.

Next slide please.  Another thing that we’ve been working on is a survey of commercial health insurance companies. And this was a five question survey that we put out in April and publicized to the U.S. ME/CFS community.

We specifically wanted to know about commercial health insurers so not Medicare/Medicaid and not disability insurance issues. This is of course a very informal survey.  It’s anecdotal.  We had 187 responses probably weighted towards negative experiences because people who have positive experiences aren’t as likely to respond to a survey.

However, not surprisingly, access to care and cost of care are major, major issues to people with ME/CFS though 62% of the responders reported either very negative or negative experiences. And we collated the responses into different categories and I’m going to go through a few of those.

So 28% of the responders said that stigma about ME/CFS has negatively affected their care and there’s some quotes here. “I have been traumatized by the way doctors have treated me”.   “The only referral I could get was to a psychiatrist”.  “Insurance concluded that ME/CFS does not exist so I was denied coverage”.

Twenty-seven percent have no or limited coverage for prescribed drugs.  Even if they could find a doctor to prescribe something, their insurance won’t cover it. So insurance refuses to pay any drugs that are coded for ME/CFS. Next slide please.

Twenty percent have no access to ME/CFS providers so this is a doctor who has any knowledge of the disease.  I have not found a provider who says ME/CFS is real and they will not treat it. The specialist who covers ME/CFS is a psychiatrist who treats it as a psycho-sematic illness.

Twenty-one percent have no coverage for ME/CSF specialists.  They (unintelligible) an outside referral there’s nothing that can be done for you. The doctors who know anything about ME/CSF are of network and my insurance pays zero for them. 

Only 31% of responders said insurance is generally okay but many of them said I have pretty good coverage but the premiums are very high. Next slide please.  One thing that was particularly concerning is that several respondents are so discouraged or traumatized that they no longer seek any medical care even for the most routine of issues.

And this represents a really catastrophic failure of our healthcare system that people are just opting out entirely even when they have a devastating illness like ME/CFS. It was also the case that specific insurance companies had multiple negative responses.

So of the 187 responses there were probably mentions of about 30 or 40 insurance companies and there were five or six where we had, you know, 10, 15, 20 responses. So, you know, for those few we had pretty good statistics and several of those had noticeably negative responses than other insurance companies.

And so we’re trying to decide exactly what we should do with the information. And in one case we know that the people who responded to the survey have banded together to try to approach the insurance company about their approach to ME/CFS.

And if you want some more information about the survey, it’s posted on our Website at Mass CFIDS.org. I think that’s my last slide. Happy to answer questions.

(Amrit Shahzad):This is (Amrit).  I want to follow this up here.  So I am leading the working group on clinical trials and treatment. And one of the things that we have identified is that there is no standard of care.

There isn’t something that you could go out to the physician and say that this is what is standard of care for ME/CFS or this is what we’re (hoping).  It is all symptomatic treatment and so I’m not sure what we are asking for coverage, exactly what that will mean and how a physician is supposed to address a patient.  So I want to…

(Leah Williams):There are clear issues that came up in the survey where things like you know, not being able to get referrals to people who are ME/CFS specialists. They do exist. But if you can’t, if your insurance company won’t cover it, it’s prohibitively expensive to go see somebody.

And it’s also not true that there aren’t any treatments.  You can treat symptoms but if your doctor says, I don’t believe in the illness, then that’s not going to be covered either so.

(Amrit Shahzad):I agree that, you know, it’s not like there aren’t treatments that will treat your symptoms medically but it’s not, it’s as much a problem of the disease and its diagnosis as it is about the insurance.

(Leah Williams):Sure.

(Faith Newton):Other questions for (Leah).

Ben HsuBorger:This is Ben HsuBorger with ME Action. Thank you (Leah) for your presentation. And the work that CFIDS, the Massachusetts ME Association has been doing.  And I think one of the interesting things that I think this survey brings out with the experience of people in the private insurance sector is why social security is, Medicaid and Medicare, is so important to our population.

Because so many people who have jobs have plans for long term disability actually have such difficulty (unintelligible) it and so this is an opportunity to where an agency like FSA can help us to have that safety net where we’re having problems in the private sector getting the treatment the patients need.

(Leah Williams):Yes, I mean this survey was specifically about medical insurance not disability insurance. We did get a few responses but that would be another really interesting survey to do.

(Amrit Shahzad):Yes, it’s good work so thank you.  A lot of information here.

(Faith Newton):Yes, I, this is (Faith Newton) speaking.  (Leah), it is really interesting information.

(Leah Williams):Thank you.

(Faith Newton):You’re welcome.  Next presentation’s by Ben HsuBorger.

Ben HsuBorger:Yes, thank you (Faith). Just one second here. All right. So if you could go to the next slide please.  So ME Action has had, so this has been, the past six months have been an exciting time for ME action as we have grown a lot.

And one of the main was that that’s happened is, as many of y0u are aware of Unrest, the documentary film Unrest, about the disease ME. And the Time for Unrest campaign that was associated around it has now kind of been brought in together under the home of ME Action.

And with that addition we’ve brought on additional staff which has really helped expand some of the work we can do.  A new Managing Director, Communications Director.  And new staff (this month), we’ve been really excited to add on (Jaime Selter) who is our new Medical and Scientific Outreach Director.

Next slide please. And this increase in staff actually also allows us to strengthen the work we have been doing as well as expand the scope of some of our work.  You know, we try to reach the public in the press letting them know about what ME is and how devastating it is in its impact upon families.

And of course backing the community, strengthening the community so that they can support themselves and educate others bring together patients and allies together in this fight for health equality.

And with some of the, we’re also expanding some of our work to educate doctors and nurses and health professionals and to inspire a new generation of researchers.

And my presentation today is going to focus mostly on points two and three but as we kind of get some of our programs up and running I look forward to telling you more about the exciting new ways that we’re trying to work on these other issues.

So next slide please. Next slide. So connecting the communities. This is one of the main things we do. We are, we have a support group called Living with ME.  It’s now, in the past six months, it’s grown by 1500 new members. It’s an online group through Facebook and also with a video conference format.

And so we’ve kind of had, now we’re up to 2500 members in this one group alone and a lot of those have come in through these outreach materials and things like the Unrest film that has been getting the word out there about the disease and about the support that there is in the patient advocacy community for people.

We’ve also tried to improve both the quality, the focus and giving deeper aspects to engagement for patient support.  And so for support, not only for patients but also for caregivers.

So we implemented a new group where more caregivers can come and discuss their unique needs for things that they face, kind of peer to peer support as well as monthly calls that are facilitated by other caregiver volunteers.

And we have a resource guide for caregiving on our Website. And next slide please. Another aspect of connecting the community is also just recognizing how underserved this community really is and so we try to provide large groups to try to bring a lot of people together.

But we also want to reach those groups who may feel left out or exploited.  So, you know, men within a disease, a disease that predominately affects women, racial and ethnic minorities, Spanish language, people who identify with different sexual orientations, groups depending on region, groups also categorized by the severity of the illness.

So we have over 100 groups. Recommend anyone who’s feeling like they need support to check us out at meaction.net/groups and you can find a group there for you. And if there isn’t a group yet, kind of we’re trying to craft these more intimate spaces for people to meet on the unique concerns that they have.

And we recently started a Veterans and Active Service Members Group as well.  Next slide please. In addition to connecting the community, we’re also trying to connect those outside to the community.  Researchers (unintelligible) of the institutions. Examples of that would be Dr. (Lenny Jason) had a survey on PEM recently and we hope to distribute that to the community to try to increase the response rate.

As well as when the (CISAC) application for new voting members went out we tried to get the word out and provide support to people who had, you know, basic questions about what these roles were, how to apply and just kind of how to facilitate that process.

We’ve also been working with researchers building upon some of the documentation laid out in previous presentations, patient engagement and making that an integral part of research. And so recently we’ve been working with Columbia to help them plan a Community Advisory Committee for their CRC and expanding that work.

Next slide please. Next slide. So advocacy work, we do a lot in this space.  One of the key things we do is our work at the state level which we really consider the learning (lap) for advocacy, try things out, see what works in a particular place.  And then hopefully communicate that information and give guidance to where we can apply it in other states as well.

So I won’t go through each of these different bullet points.  There are different links here if you want to check them out.  I will point out two of the success in New York was getting educational material about ME into medical provider publications in NY as well as getting the NY State Department of Health to launch a new webpage that had information specific to ME. 

And we’re really excited about that.  Next slide. Another thing that we’ve been doing in the past six months is in line with behavioral risk factor surveillance system annual survey.  And so trying to get state health officials to track ME/CSF and then use that, the BRFSS to do it.  So there were two ME/CSF questions that were proposed and in previous years they weren’t included in the survey because there wasn’t enough support from health officials.

And so we did a national campaign state by state to have people contact their State Department of Health officials to communicate to them why it’s so important to track ME/CSF and how ME/CSF affects people in their state.

And as a result of that at the last meeting at least 70% of health officials voted on these questions as important which allows them not to be considered as optional status for the survey.

And the states that use them will receive some funding to implement them. And so we were pleased with that and look forward to continuing communicating to Department of Health officials about the importance of tracking ME/CSF.

Next slide please. Another area that we work is in doing political advocacy. Of course we try to do all of this in coordination and collaboration with the other organizations in this field. So ME/CSF Initiative, Massachusetts CFIDS/ME & FM Association and we’ve been working for many, for years now. 

One of, some of the key things that have been done, in March, getting 44 representatives to sign a letter to the Appropriations Committee advocating for ME as well as this May, as (Leah) mentioned, the Senate Resolution which has bi-partisan support as well as a letter to the House Sub-Committee requesting a hearing on the clinical care crisis of ME.

And that has bi-partisan support as well.  And we are encouraging, you can always go to our website, meaction.net/congress and, or use those (unintelligible) here in this presentation to contact your local officials and communicate to them the importance of supporting these initiatives.

Next slide please.  So another major thing that ME Action does is coordinate a yearly Millions Missing Campaign that we do in May. This one happened in 2018 on May 12.  And we had the community come out, this is a global initiative all across the world

And in the U.S. we had 28 different public demonstrations.  (Leah) mentioned the one already in Boston. And our focus in the U.S. was to, this year was to call on the NIH to take urgent and strategic comprehensive actions to address this crisis.

And so, next slide please. So there’s a link there, to Millions Missing.  Like I said this is a global initiative.  Over 100 cities around the world participated. And what we did was put together, we had a group of experienced, long term advocates come together and put together a letter to Francis Collins at NIH and outline the things that we think are needed in order to move forward and ask for a meeting from Dr. Collins to discuss these findings.  And we had over 7000 people write in supporting this letter and signing onto it.  And we have brought it up too pretty earlier.  We’re very much looking forward to hearing back from Dr. Collins and just sitting down with him to discuss this.

And really if I can just stand back for a minute, you know, just to, all of us know this, just asking for a meeting for a while. We know the problems here and what we wanted to do was to, we know that you care and want to address them but we want to get to the fundamental issue of the reality in the community was that if things don’t, if we don’t change things concretely and tangibly where people advise, then none of this stuff matters.  

And so we wanted to work backwards from what are the outcomes that really, that would make a difference in people’s lives and then how do we get to those because that’s really where we need to start the investigation, is about outcomes, how we change the situation and not simply accepting the situation as it is.

So next slide please. So this letter which all of you can read if you click on the link, about 2.5 pages long. We really outlined three things that we think are the outcomes that are needed and that’s the diagnostic test.

And within three years we think there should be a validated clinically viable biomarker for ME and to get to the place where we can start, in a year and a half to start NIH trials for at least one drug that would treat ME.

And in terms of treatment within 3 to 5 years secure FDA approval for at least one treatment specific to use in ME. And so these are the things that would make tangible differences in people’s lives. These are the things that would have cascading effects across all of our agencies here and how we do our work and what we’re able to do.

And so these are really the goal markets that we see both in the short term and with 10 year goals. Next slide please. So this is where we need to go and how do0 we get there?  So in our letter we outlines 11 different actions that we see as feasible things that NIH could do, research actions they could take within the next 12 months that would help us, that would allow us to meet these goals and make tangible moves forward.

And the reason, you know, we laid these out is because we can’t just keep tinkering around the edges of these things.  It’s not enough to do one thing here and one thing there. We need a comprehensive approach to solve this problem.

It’s a complex problem.  It’s been decades in the making.  You know, all of our agencies are implicated given the situation that exists today and so we need comprehensive action to be able to address that. And, you know, the reality is if we don’t address this, we know what will happen.

Next slide please. This is the part of the presentation you guys who have been to these before are all familiar with. We talk about the people who haven’t made it between our last meetings. And no, I’m not going to give you a comprehensive list of people but I’m just going to highlight one person within our community, (Harvey Cardin) who died earlier this year.

This is a picture of him. He came to the Michigan State Capital steps giving a speech for Millions Missing in 2016.  Harvey is a U.S. Veteran.  He’s had this disease since 1973 and as it progressed it got, it went from more moderate to severe and it’s never gone away for him.

And he, and sadly (Harvey) did not make it to our next, to the Millions Missing in May of 2018.   These are our friends and our family that we’re losing to this disease. Next slide please. As you click on the link to that speech you will see (Harvey) speaking from the heart about how he’s affected by the disease, how he seeks to encourage all of you to check it out.

Its four minutes long.  He ends it saying. NIH and HHS, I’m so tired of fighting.  Please help us.  And that’s the, that’s the reality we live with that, you know, I appreciate everyone gathering together.  Appreciate all of the work that this takes and the complexity of this issue.

But we have to keep coming back to and this is what I’m going to keep doing, is reminding all of us that nothing matters about our meeting together and what’s forestalled in this crisis.  And good work is being done but it’s not going to be easy but it’s possible to do this working together.

And the community is at a place where we are expecting to mandating action and we look forward to collaborating with each of your agencies in finding new, sustaining, creative ways to addressing the embedded problems that are there and making a difference in patient lives.  Thank you.

Man:Thank you (Ben).

(Faith Newton):Thank you (Ben). Questions for Ben HsuBorger about his presentation.

(Amrit Shahzad):I have comments and this is (Amrit Shahzad). So as I said previously, I am chairing the group working on clinical trials and treatments. And I am very blessed and fortunate to have representation from the (officials) in my committee.

I have (Vicky) and (Andrew) from NIH.  I have (Beth) and (Sally) from CDC and I have (Givanna) from SEH. So I know that these individuals are working hard and beyond their daily jobs to help this community.

The two things, two comments I have for advocacy group and for full disclosure here, I am a patient. I am trained as a physician and although in the list I am listed as a researcher, I am a business development person who’s done clinical research but has had the good fortune of looking at drugs in development and understanding what the process entails.

These are suggestions I have. One, you know, as we ask more of the agents it would help if we come up with suggestions of actual things that they can do and how they can leverage the resources their organizations have to advance our cause.

It’s not just enough to demand.  It’s also on us to tell them how we can help pus move that needle. They have to go by the processes that they have to follow and we should work with them to help us, ourselves and our community.

That’s one.  Two, I would also recommend that there are multiple patient advocacy groups who work in this space.  We should coordinate our mission between the agencies and figure out what are the common resources?  What are the common requirements?

What is done buy all the agencies, all these advocacy groups together would provide our efforts synergy. I think there is a two way street here that we need to talk about. The job that the patient advocacy groups have done in improving education, in raising awareness, in looking at different means at funding is absolutely phenomenal.

By the same token the work done by the agencies in promoting the understanding of the disease and presenting it in mainstream forum. And working on common data elements so that the data can be comparted across trials is actually exceptional.

What do we do beyond that? And how do we do it together so that this moves effectively, would help us more than just saying, do more?

Ben HsuBorger:Thank you. 


Ben HsuBorger:Yes, I agree with, sorry, go ahead.  Did I interrupt you?

(Amrit Shahzad):No.

(Faith Newton):No, (Ben), I’m going to let (Ben) respond and then I have, this is (Faith Newton), and then I’m going to let then respond and then I have a comment to make.

Ben HsuBorger:Great, thank you. And thank you for those detailed comments.  And I appreciate the work that everybody on this committee is doing. They are clearly dedicated individuals that are going above and beyond

And to clarify, but if you would take a look at our letter again, it’s only three pages, that it will kind of lay out for you more of the details. But what we’re trying to do is not simply make demands of things to be done but to ask for a seat at the table to ask about how to get there.

And so what I submit and I don’t think anyone around this table can, you know, deny, is that without a comprehensive approach we’re not going to make the progress we need and to do that there are multiple doctors that come into play.

So we try to sit down and secure the different mechanisms that we see that could be feasible that could affect this work. And, you know, we see this as a starting point for negotiations.  So this isn’t the end of a conversation but it’s the beginning of one.

And we’re still waiting on a reply from Dr. Collins to meet with us to discuss this more but, and we would look for any forum to have those conversations about how we can work more creatively together. If my colleague (Carrie Waldo) was here who also represents ME Action, has a deep history working both in medical education and in AIDS activism, is that, you know, we look to the perspectives of other communities and groups like HIVA (Activists).

And the success that they had was working, sometimes they had to push strongly but it was getting a seat at the table to have real discussions about some of these problems.  And, you know, that goes back to some of my earlier comments about how do we draw more people to get around the table together, whether this is the ICD-10 coding or whether this is patient selection for research.     

Whether this is, you know, administrative (unintelligible) judges understanding what CFS is and not believing that it’s something psychological. All of these things are going to take collaboration but we need to sit down at the table together and work out real results.  Thank you.

(Faith Newton):Ben, this is (Faith).  The work that you’ve done in (unintelligible) is commendable and unparalleled. And (unintelligible) has done some, I mean all of the advocacy groups have done some amazing work to get to their DOH launching the new webpage about ME.  That’s just, that’s amazing.

The, I think what concerned me about the presentation was slide 15 and 16.  I don’t operate on, I think we’ve had in the past issues with groups making demands. And the problem with that is that that starts the conversation off on a wrong note.

And what I want to say is that I’m trying to get all of the groups, (officials), and the advocacy groups and all of us to work together. And so when we start with demands, that puts us on different sides of the table. And I think that’s where, that doesn’t start us off with the right conversation.

So I would like to ask, because that’s not, the conversation that you just had with (Amrit) as want to sit down and have a conversation about what’s going on but that’s not what you wrote in your presentation. So I’m hearing different things.

Ben HsuBorger:Well so what I’m saying I think (Faith) and thank you for asking to clarify here, is that we want to have a conversation but we don’t, we want to have a conversation working backwards from the real goals and how we get there.

And so I don’t think, you know, I don’t think it’s new to say that we want a diagnostic test, that we want clinical trials, that we want treatments. But we’re saying to make a difference now in people’s lives, how do we get there? And we’re trying, and what we’re trying to do is lay out the roadmap for what this could look like.

And, you know, and I think, you know, our position and our commitment are clear but there has to be more work done to have a diagnostic tests, to have clinical trials, to have treatments. And if we come together and talk, work this through, we can find a way forward.

So we’re not saying there’s only one way to get here but we are saying we all have to commit to this goal and then do real collaborative work to figure out how to get there.

And I think if you take a look at the, you know, these slides, I tried for brevity just to hit the main points but I think if you look at the details of our plan, that would be pretty clear what, that we’re not making unreasonable or unsounded requests to people who worked on this.

We are aware many of these are complicated in how different actions feed into each other. That’s what I’ll say there.

(Faith Newton):Thank you.

(Amrit Shahzad):So if I may add to that. So while…

(Faith Newton):Who is it? Who’s speaking?

(Amrit Shahzad):This is (Amrit).  This is (Amrit). So while none of this is unreasonable, there are different advocacy groups all of which are moving in the same direction and there’s a lot of overlap in the demands of people

All of us are headed in different directions.  You know, we all want that there be a better case definition or an understanding of this disease that we get to a biomarker.  We all want the same thing.

There is no difference in what the end goal is for all the patient advocacy groups. How we get there differs in each and every person, (Ben). So as I’m reading your slide number 15, you talk about a diagnostic test.  You talk about clinical trials. You talk about treatment.

That’s pretty much similar to what Simmaron says. So…

(Faith Newton):Can I interject here actually? I’ve got something.

(Amrit Shahzad):Can you let me finish my point?

(Faith Newton):Wait, wait.  Just a minute.

(Amrit Shahzad):Let me finish my point.


(Amrit Shahzad):All I’m saying is that while we’re asking all these things of the agency, I think the patient advocacy groups also need to coordinate between their groups the efforts that they are making towards these goals so that when we ask the agency for help in achieving some of these goals, we have a unified front.

If three different groups come with three different suggestions all speaking to us the same goal, it creates some degree of chaos that needs to first be sorted out. 

If the advocacy groups talk between themselves, get alignment on what that means and what that timeline should look like, it makes a one voice that NIH can then deal with and say, these other things that we can bring to them or not bring to them or this is how we can move forward. 

It makes the discussion simpler, easier and more effective.

(Faith Newton):Okay, next please.  Who wanted to speak next?

(Courtney Miller):This is (Cortney Miller).  We have actually done a lot of work in the patient community and the organizations to do that and I’ll refer to a few things in a second.

I wanted to start by saying I think the core points and I’m grateful to have the other organizations working, doing the work they’re doing on this disease. And I think the different organizations do different things in creating a much more active and proactive approach to solving the problems patients have with this disease which is ultimately the charge of this committee..

So there was a strong effort to coalesce a number of different patient organizations in the couple of years following NIH’s renewal, the announced renewal of their ME/CFS research program. 

I worked on two or three sets of very detailed recommendations that four or five of us in different groups with different experiences, pulled together and got maybe a dozen, ten to a dozen patient advocacy organizations and additional advocates supporting and submitting to NIH around the, specific recommendations around different goals of a renewed NIH research program.

Around methods and options for patient engagement with NIH and some overarching goals that reflected and ME Action has done more work on since. So there is actually a history of putting together composite consensus recommendations on the research that needs to get done and the integration of a community.

And some of those have been acted on by NIH.  There are many more. And a similar set of recommendations with respect to medical education have been put together with and submitted to the agencies responsible for that side.

What I wanted to comment on is, the point that I think ME Action and (Ben), you just made very distinctly and clearly is, we need strategic plans at every agency that has a responsibility for this disease.

We need one at HHS and they need to also come up with the elements of that strategic plan that fit their charge.  We aren’t just demanding.  We are making recommendations.  However the way they get acted on in various agencies is, part of this conversation that we have in CFSAC.

And part of the reason I have been attending and watching the IFFAC process at least since 2005.  And so there is much more potential now to work together and I very much appreciate your comments (Faith).

And we all want to work together with specific ideas or to input on the agency’s specific ideas. But it is time, past time for a lot of agencies to come forward with direct strategic plans in their purview and solicit input from FISAC and the community.

In most diseases and advisory committee like this actually gets questions from the agencies. What recommendation do you have about this activity? Or this initiative? Or this plan?  And we still need to get there with many of the other agencies at the table.

And I think this is where I was left wanting with the comments of the Assistant Secretary of Health.  We, I have heard introductory remarks by five or six Assistant Secretaries of Health. 

We need, we need initiatives and plans at every level of HHS and we need to be part of creating that. And that’s what the organizations are asking for.  We are doing specific work to bring that forward in detail.

And this body CFSAC, needs to make recommendations so that our input can help inform more aggressive strategic plans for the agencies.


(Courtney Miller):(Unintelligible) is the name, ME/CFS and the work that (SEID) ME/CFS has done on this as well as other organizations who have actually pooled a series of recommendations to move programs.

(Faith Newton):Let me thank, let me thank the three liaisons, yes, let me thank the three liaisons, organizations.  It’s 11:56 so we are going to break for lunch. There will be music and we will start promptly at 1:00 with the public comments.

Please, all of the members of CFSAC take notes because we’re going to have a 15 minute conversation after we hear the public comments.  Just (press) the comment on what we heard. So we will reconvene, the members get back about 12:55, 12:58 so we can start promptly at 1:00.

Man:And then (Faith), this is an announcement for those members of the public who are on listening mode only, we start at 1:00. You have been assigned a time. The Operator will call your name and give you instructions as to how to unmute your phone and you will have five minutes to address the committee.

(Donna Pearson):(Faith) this is (Donna).  I’d just like to plug a group of advocates that are working together very quickly, if I may. It’s called the U.S. Action Working Group and many of the organizations are involved.

(Charmine Prosco) chairs it. They meet by phone once a month. It’s a loose, you know, it’s a loose organization where they can…

(Faith Newton):(Donna), why don’t, we’ll have time…

(Donna Pearson):…that was known to this committee.

(Faith Newton):Okay, we should have time to do, we should have time afterwards. Can you just put it down in your notes so that at the end of the day when things, when people have just said things, that would be one of them because…

(Leah Williams):This is (Leah Williams).

(Faith Newton):It’s like 11:58.

(Leah Williams):This is (Leah Williams).  Can I make one comment?  I’m getting feedback that people are having trouble getting into the meeting but they’ve registered in that online questionnaire thing and then nothing happens. I don’t know if there’s anything anybody can do about it but people are having trouble accessing the meeting.

Man:Are they using Chrome?  Usually that’s a problem.  Sometimes that’s a problem.

(Leah Williams):Okay, I will suggest that that gets sent out on Twitter. Thank you. But (Leah), tell them that they don’t need to use the code. The code is to listen to the discussion. When they click on the URL which is on the CFSAC website, they just need to fill out their name, email, organization but they do not need a code.

I just responded to somebody on the inbox saying that, asking me whether or not the code to dial into the 800 number was needed also to dial into the URL to view the presentation and they are two different things.

(Leah Williams):Yes, I understand that.  Okay.  Thank you.

Man:Thank you.

Ben HsuBorger:Thank you. And sorry, this is (Ben) with ME Action again. Just to say before we go to lunch I can send around an email with the full letter to all the committee members so that they can read it and understand.

I think there is a little bit of confusion because ME Action has been actively working closely with Massachusetts CFIDS/ME & FM Association, ME/CFS.  The collaboration is not the issue, we, and this letter represents the voice of over 7000 people across the U.S. So I do think it’s important to, for all the committee members to consider and be aware of all these recommendations. 

(Donna Pearson):Yes, my name’s there somewhere. Okay?

Ben HsuBorger:Okay.  Thank you.

(Donna Pearson):I agree with you so you’re welcome.

Man:We’ll be back at about 12:50. Thank you.

Coordinator:Thank you for standing-by. We are ready to proceed with the public comments. Thank you.

Man:Thank you (Julie), (Faith).  Welcome back everyone. We are ready for public comments. And we will start with Citizen 1. You have five minutes Citizen 1.

(Citizen 1):Thank you very much.  Good afternoon. As you heard, my name is XX). I’m living with ME/CSF.  Diagnosed a year ago after actively seeking a diagnosis beginning in 2012.

As a healthcare professional, I’m appalled by this time lag and want to underscore that my health today is worse as a result of this delay. It is important to note that on average it does take five years for individuals to be diagnosed.

My experience is all too typical. As a public health special work academic, my mission focused on the impact of chronic health of women in the family - little did I know that as I became disabled I could not find an explanation for the crushing flu-like symptoms when I tried to function as I had throughout my adult-life.

(Faith Newton):Hello.

(Citizen 1):I have been a highly active person both professionally and personally. I love…

(Faith Newton):Yes, I’d like to…

(Citizen 1):I love spending time with my family and friends.  A typical day included horseback riding, skiing, followed by teaching graduate students/ Scholarship was written in the early hours of the day before my children awoke

Now my world is very circumscribed.  I fatigue with mental and or physical exertion.  If I had to work full-time, I could not. My pulse rate jumps to 168 with walking.  For all the times I’ve tried to push through this illness has ended up in bed with severe pain and a variety of symptoms.

One doctor asked why I was so (unintelligible) my condition. My professional credentials were dismissed and I was diminished as a person. Yet I knew my health was getting worse involving more body symptoms.

Hope began for me in the fall of 2017 when I attended the Open Medicine Foundation’s World Tour Report presented by Linda Tannnenbaum, sponsored by (Mass Seaford). 

Through vigorous research, aggressive fundraising and a commitment to providing hope OMF is funding collaborative research initiatives.  Where are these federal leadership efforts?  Current NIH funding must be increased. Perhaps the comparison will remove the situation.

My brother recently diagnosed with stage four prostate cancer. And we are living strikingly different lives while fighting illnesses. Today he’s meeting with a myriad of cancer specialists and weighing post-surgical treatment options ranging from radiation with or without chemotherapy while exploring a number of clinical trials including immunotherapy.

By comparison I had to travel to New York City to be diagnosed and there are no clinical trials. MEAction recently delivered an action plan to Dr. Collins on May 15 that demands more research, education and care. The plan is ambitious and very much overdo. 

The action plan provides a blueprint for simultaneous development of case definitions, research and trials. I want to focus my remaining time on the critical needs for clinical care for this complex multi-system disease with few providers having expertise in ME/CSF.

Well ME/CSF is more common than common conditions like MS and Lupus.  Funding and research lags behind. In my state alone, New York, an estimated 61,367 to 152,428 children and adults have ME/CSF. 

And May 2, May 12, the International Day for ME/CSF Awareness, we showed the documentary Unrest at the University of Rochester with over 80 people attending from the medical center in the community. Many of the patients have been cared for by Dr. (Bell) and they reported that there is not a local ME/CSF specialist since he has retired.

This is not acceptable. Informed clinical care is needed while research is being performed.  New models of care are urgently needed where specialists share their expertise with providers throughout the country whether via tele-medicine or other models to improve accessibility to care.

There has to be a concerted effort to capture the expertise of these ME/CSF specialists before they retire. I am providing my testimony and will continue to pursue advocacy going forward so that others will get a timely diagnosis, quality care and not be labelled as having psychological disorders.

There’s no secondary gain to be accrued from this condition. In my professional training CSF was called Yuppie Flu. Mental health professionals need the same educational efforts as those being called for all medical sub-specialists.

Ignorance can only damage those who have ME/CSF. Today I’m a woman with a disability who continues to be without a diagnosis, diagnosed tests, FDA approved treatment and an uncertain disease course.  We’ve waited long enough.

Community organizations not the federal government are pushing the agenda.  I invite all of you who work for HHS, CDC, NIH, the FDA or any other governmental agencies to join. Action is needed now. Thank you.

Man:Thank you.  Operator, do we have Citizen on the phone?

Coordinator: We do.

(Citizen 2):Can you hear me?


Man: Go ahead please.

(Citizen 2):          Good afternoon.  By my calculations, I’ve participated in more than 20 CFSAC meetings since 2007. Without them I could never have imagined that as the mother of two sons severely ill and homebound with ME that I would so little progress in these eleven years from HHS agencies.

In October of 2010 my son told this committee “the horrible thing is I’m not sure how devastating this illness really is.  I’ve been sick for so long that I don’t know what normality feels like. I used to swim four times a week, five miles each time.  Now I can’t get my heartrate over 160 beats per minute by running in place for 30 seconds.

I used to be a straight-A student. Now I can barely concentrate for 20 minutes in a day no more than three times a week. After that it gets exponentially more difficult and exhausting.  I used to have a typical active life.  Now my daily life is impossible to plan in advance because there are days when getting out of bed seems beyond absurd”.

In October of 2010 my son (Alexander) told this committee “I taught myself to read at the age of four. At the age of six I was reading computer trouble-shooting magazines and understanding them. Now I read and reread things to try to ensure that I understand them.

I used to be able to remember where I had last seen a book, a game, a drink.  Now if I set my water bottle down close to the sink to wash my hands I often walk away having totally forgotten that I wanted to take a drink back with me.  I used to empty and fill the dishwasher, change the sheets on my bed, put away my clothes, as some of my responsibilities.

Now each of these activities triggers tachycardia.  The pounding, rapid heartbeat exhausts me and leaves my brain even more fogged.  I used to attend school full time participating in theatre and swim competitively. Now I am housebound.  I want to be more active.  I want to be able to hang out with people.

I want to be able to go to school.  I want to be myself again”. And here we are again, 2018, another CFSAC meeting. And I’m still at each one because patient’s lives are at stake still. More than 13 years have gone by since (Mathew) came down with ME at the age of 12.   He’s now 25.

More than 12 years have gone by since my son came down with ME at the age of 14. He’s now 27. After all these years after they’ve gotten ME, my sons are just as severely disabled by ME. 

They require 24/7 care, are unable to reach their intellectual potential, unable to live independently and are just as severely disabled by ME as when they got sick because there hasn’t been enough biomedical research to develop diagnostic tests, run trials and develop treatments for patients.

It’s because of the persistent and appallingly low level of funding for ME research that there are no appropriate diagnostic tests, trials and treatments which would enable my sons and all patients to have a better quality of life, improve functionality and are returned to productivity.

In a letter to a patient NIH talked about its commitment to accelerating biomedical research and funding for ME to finding treatments and a cure. It also talked about things like program announcements and grant-writing workshops to help those submitting grants.

Sound great, huh? Ike they’re doing things for us, right? Here’s the catch. The letter was written in 2010, the same years as my son’s comments to this committee. Parts of the letter read very much like NIH’s language in their fiscal year 2019 appropriations’ submissions.

Nowhere in the letter from 2010 or the fiscal year 2019’s language, is there evidence that NIH is urgently addressing the needs of those affected by ME. Nowhere is there evidence that NIH is aggressively maximizing all of the tools at their disposal.

Nowhere is there evidence that NIH is being innovate in their response to the decade old need to accelerate biomedical research and increase funding in order to solve ME. NIH has repeatedly failed and continues to fail to aggressively maximize all of the tools at their disposal.

In May of 2018 Dr. Collins received a letter signed by over 7000 people detailing a plan of action that could easily accelerate the pace of ME research.

(Faith Newton): you have…


(Citizen 2):If you haven’t already, I urge you to do so.  As Ben said earlier, the letter was developed as a framework of action that NIH and HHS agencies can take now concurrently to move things forward in a scientifically sound manner.

The letter includes suggestions from multiple, simultaneous efforts such as issuing (IFAs), ensuring development of the much needed consensus derived research pace definition, funding program announcements, accelerating the pace of the intramural study, issuing administrative supplements, provide additional support to the CRCs and the (MCCs), funding additional collaborative research centers, establishing a cross-agency strategic research plan, et cetera.

Coordinator:     I’m sorry but your time is up.

(Faith Newton):I was just going to say that.  Thank you very much. And thank you for sending your comments in writing to the committee.

Coordinator:     To all the individuals providing public speaking, can you please keep your limit, your time to five minutes? We have a number of individuals who also want to speak. The next person is Citizen 3. Operator.

(Faith Newton):I’m going to give you a 30 second warning so that you know when and then I’ll tell you when your time is up. This is (Faith Newton).

Coordinator: Citizen 3.

(Robert Miller):Yes, hello. Can you hear me?

Coordinator:     Yes Sir, go ahead.

(Robert Miller):Yes, hi. Long time patient. Since 1982 you do not have written testimony from me.  I refused to have my wife write it for me. I’ve been doing this since 1998 trying to get NIH to move in an expeditious manner to help us who are ill.

I know from experience for 18 years, out of those 18 years, that I’ve been able to access the drug Ampligen that has allowed me to function. I have not been able to access Ampligen for the past two years.

I have not been able to function for the last two years.  This committee and you’re here to represent the patients, you need to be the driving force to get things moving.

I have regurgitated this for two decades with different members changing hands every few years.  And we get a new rep in and they think they’re going to just take the world by storm.

There’s been discussion that if we just attempt to access the pharmaceutical industry because FDA or NIH makes a request that they’ll coming running, well, I’m telling you with 20 years of experience that that’s crap.

It doesn’t happen that way and until this committee, people sitting on this committee actually become a driving force, we’re not going anywhere.  We haven’t gone anywhere for 20 years.

I’ll leave you with one request. There has to be treatment clinical trials and however that has to happen, it has to happen.  I regurgitate the message of going back to the days of AIDS, there was not restrictions on the pharma companies and there was money coming in from the NIH, the CDC to try any and all treatments. 

If you people sitting at the table had been chained to the bed the way us patients are, you would be jumping up and down and screaming. I thank you for the time to be able to speak and I ask this committee to hear what (Denise) just said about her two children and think about your children.

Thank you.

(Faith Newton):Thank you for your comments Citizen 3.

Coordinator:     Operator.  Can you please have Citizen 4 on the line.

(Citizen 4):Hello.

Coordinator:     Yes, go ahead.

(Citizen 4):Can you hear me?

Coordinator:     Yes, go ahead please. 

(Citizen 4):Hello, my name is XX and I’ve had ME for going on 33 years. I never thought in a million years that my life as it stands fell by this illness named ME would be the life I would end up living.

It’s not that I thought I was so special or that I was untouchable but my life started off with so much promise and excitement that I thought the sky would be the limit.  My life has turned out to be anything but limitless.

When ME appeared at the age of 24 it was like a bowling ball fell out of the sky and crushed not only my body but all my dreams and my hopes to boot.  It strangled my future, strangled all my ability to physically move. 

Do you know what does to your soul when you have a real zest for life and you can’t express it because your body doesn’t produce enough energy to allow it?  It smashes the pieces of who you thought you were meant to be while leaving you, the remaining chard of trying to put yourself back together again in a way that makes sense.

There’s no making sense of this the way things stand. We have nowhere immediate to turn for help.  My once beautiful life has become disfigured and fragmented by illness, pain, financial hardship, loss of opportunities, relationships, career and all the, what could have been.

I feel like such a burden to my spouse now as he as to do the lion’s share of the work by working two jobs all the while tending to my many needs. He never gets a reprieve but I don’t either.

This illness is unrelenting bringing on lots of physical and emotional suffering with much isolation because of the effects of this illness. ME has left me with an impaired immune system, (unintelligible) system and aerobics system which means I’m at risk for opportunistic infections like pneumonia and cancer.

And I can’t walk more than 50 feet without the payback price of being in bed for weeks and months at a time feeling so ill, it’s as though I’ve been poisoned. It’s not a fair trade for trying to live.

The last three years I’ve been relegated to using a mobility scooter to make my way around about in the world when I’m not strong enough. It took, excuse me, when I am strong enough. 

It took me two years to come to that painful decision three years ago.  Don’t get me wrong, I’m happy to be out in the world when I can be but this is not the life I envisioned.

The variability of how I feel physically with ME within a day is a kin to passing all four seasons of the year in one small swoop. How do you plan your life around that?

I try to find joy where I can but I think what is worse than the death of your life as you knew it is having the stigma of this illness continue to be pervasive amongst the very folks who are supposed to be helping us. And by the way, where are those folks who are supposed to be helping us?

The stigma and the lack of understanding about this disease create insurmountable roadblocks for patients and families to gain appropriate medical care and treatment for all of us. And it’s the hardest thing emotionally to deal with.

It one thing to draw the short straw in life for health but to have to live with everyone’s back turned toward us as though we don’t exist, is more than anyone of us can bear.

And only a few of us are lucky enough to be able to get into an ME specialist because they are so few and far between. There simply have not been enough research money certified by the NIH to make a real commitment to finding biomarkers and a cure for ME.

We need $200 million a year which is fair for a disease our size and commensurate with the disease burden we have to carry. After almost 33 years with ME, there are still no FDA approved medications. Why not?

We need more clinical trials implemented with different medications like Ampligen which have been shown to be promising and make them accessible to all.  (Cortney)’s presentation representing Simmaron, Dr. Peterson so clearly outlined, from treatments clearly being used which have been used for decades very effectively. That could be a great benefit to other doctors and patients.

We need the CDC to implement training strategies in tandem with our ME specialists for our clinicians and medical students so that every family physician and ER doctor can help us.

Please bear this in mind CFSAC committee. The clocks have been ticking for decades. Those of us who are ill keep getting older and sicker but in the meantime new patients continue to develop this disease and are not being identified and diagnosed with ME and so it goes.

So if a request for recommendations look like demands, it’s only because decades have gone by and we have only moved forward a fraction from where we’ve been standing all along.

Please make it a priority to discuss a plan of action. Consider using ME Action’s letter to Francis Collins which (Ben) discussed earlier today which outlines this process and use the invaluable information (Courtney) has provided today.

It will speed up this process to develop what we need from our governmental agencies so we could be given a chance to live and contribute and for our families to receive assistance. Thank you so very much for your time today.

Coordinator:Thank you.  Operator, Citizen 5please.

(Citizen 5):Hello.

Coordinator:Yes, sir, go ahead.

(Citizen 5):Yes, thank you for allowing me the opportunity to speak. Educating healthcare providers.  My experience with ME/CSF goes back over 20 years.  I was fortunate to be under the care of one of the few experts at that time here in Michigan.

I was treated with high doses of antivirals.  As a result, I had a 13 year remission from the most debilitating effects of this illness. Suddenly in February 2015 I became very ill again.

Unfortunately returning to the previous protocol, antivirals was no longer effective. My physician understood how poor my quality of life had become and offered me a more powerful antiviral treatment which brought about some amazing and positive changes to my health.

I was shocked when the next week I was informed that my physician had suddenly passed away and that my treatment would not continue. Without the treatment my health began to decline again.

I contacted the hospital where this physician was on staff to find out who would continue my care but no one was continuing treatment for his ME/CSF patients.

While looking for a new doctor at the hospital’s infectious disease department, I saw the caption, does not treat chronic fatigue syndrome written next to many of the physicians’ profiles.

I felt like a population of patients had been blacklisted from a hospital based on their disease. It is difficult for me to imagine a hospital turning away patients if they had a more respected chronic illness such as MS or Parkinson's. I had appointments with several other physicians in Michigan to see if there was anything they could do to continue treating me. I was surprised to learn that although they had heard of ME/CFS, they really didn't know much about it and frankly just didn't seem interested.

Because of decades of believing that this illness is psychological in nature, there continues to be a deep seated bias against this disease regardless of all the objective biological findings. I have children and we are concerned that they may someday become ill with this affliction. During the past year, I've spoken to two pediatricians who have assured me that kids don't get this disease, which is absolutely not true.

Primary care physicians are the gatekeepers of our health care and they need to know some basic facts about this illness called ME/CFS. Educating healthcare workers about this disease should be done by our medical schools and health agencies, not by patients. Compassion for patients. We need our healthcare staff to be sensitive to patients with ME/CFS. This disease is an opportunity to show compassion for the patients despite not knowing all the answers. Showing compassion -- and really listening to the patient -- is something that can be done today and does not require FDA approval nor anyone else's approval.

How many lives and families could have been preserved if we could have not only recognized the disease, but also the economic toll, isolation and poor quality of life with this disease lives. Even if healthcare workers don't feel that they have the ability to offer treatment, they can at least recognize the suffering and say, "I'm so sorry you have this disease. I will do the best I can to support you during this time."

This is how ME/CFS specialists speak to their patients. Those words can mean all the difference for a patient. Funding. While patients are being supported, we need more funding now. The NIH has the following mission statement published on its website – NIH's mission is to seek fundamental knowledge about the nature and behavior of living systems and application of that knowledge to enhance health, lengthen life, and reduce illness and disability.

If the NIH intends to keep its actions aligned with its mission statement -- and not discriminate against people with ME/CFS -- we should see a dramatic increase in funding for this disease.

If we use a conservative estimate -- and assume that there are only 1 million patients in the US using disability adjusted life years to determine the disease burden -- the funding for this disease should be increased from $16 per patient to $188 per patient. There are brilliant -- and very motivated -- scientists ready to study this disease. I have met some of them at Stanford and the Open Medicine Foundation and they are very committed and passionate about curing this disease. Passion and commitment aren't enough. They need funding now. Thank you.

Man:Thank you, sir. Operator, do we have Citizen 6 on the line?

(Citizen 6):Yes, I'm here. Can you hear me?

Man:Yes, ma'am. Go ahead, please.

(Citizen 6):Hi, I'm XX. I am a 49 year old person living with ME/CFS. I developed a mild case of ME/CFS in 2005 after a stomach virus. Overwhelmed my already taxed, hardworking, new mothering, self-employed body. By 2015, I had a moderate severe case of ME/CFS and I'm now primarily house bound. I believe my decline from mild to moderate severe was due to the 10 years I lived without a diagnosis.

During that decade, I was set on a course of downward progression as I fought hard to stay active and get healthy from a strange disease that my doctors were unable to identify. I had no awareness or knowledge about ME/CFS and apparently neither did my family doctors, rheumatologist, or endocrinologist. Had any of my doctors known to screen me -- using the Canadian consensus criteria for the international consensus criteria for MA at any point during that first decade -- they would have easily been able to diagnose my case.

I have lost my life to ME/CFS. I just haven't died from it yet. When I do finally die, it's doubtful that any ME/CFS will be recorded as the cause. This is typical and keeps us all in the dark about how many lives are taken by the disease. The symptoms with ME/CFS --  that I live with every day that I've grown accustomed to feeling -- are systems that will alert most people to a heart attack, several types of cancer and even stroke.

For me however, the warning signs that save other people's lives will most likely go completely overlooked, just another level of pain or weakness in an ever changing landscape of suffering. So if I die from a heart attack, will it really be the heart attack that kills me – or the stroke – or the ovarian cancer? Or will it be the ME/CFS because it makes pain and exhaustion so normal that it renders me incapable of believing that increased pain or exhaustion is cause to go seek help.

There is also the possibility that I could easily become homeless. Had my disease been diagnosed earlier -- within two or three years instead of 10 -- I believe I could have continued to pursue my career with adjustments made to accommodate the illness. Instead, the progression of my disease -- coupled with no diagnosis -- meant my career to evolve slowly until I could no longer work.

Without a diagnosis, I held fast to the belief that I would be well enough in time to resume my career. So enough time dig path that I no longer qualified for disability benefits. Should my husband -- my sole provider who must work two jobs to make ends meet – die, I will have no way to pay to keep a roof over my head. My daughter and I will become homeless and without medical care. So if I die of exposure or lack of medication when I really have died from any ME/CFS, there is no way of knowing how many people have actually died -- as a direct or indirect result of any ME/CFS -- because no one is tracking it.

I'm sure that if we could quantify it, the numbers would be staggering. It sounds melodramatic, but the truth is we need to identify as many people with ME/CFS as possible. We need definitive authoritative medical education right now today. The NIH, the CDC, and the VA need to be specific about which diagnostic criteria should be used, what treatments work, what treatments are harmful, and what aspects of the disease are being studied. None of this information is new. It just needs to be out there.

We need outreach to the insurance companies who drive our healthcare system. If they can see the benefit of early intervention, perhaps they can be part of the education solution. We need accountability from medical education brands like the Mayo Clinic and Web MD. Sources such as (unintelligible) need to make sure the links for chronic fatigue syndrome connect to the complete information about any ME/CFS because doctors seem to have little to no knowledge about the disease, let alone the update to the name.

There was is so much unnecessary suffering and expense due to the complete disregard for this illness that nothing short of an all hands on deck approach is going to put the name Myalgic, encephalomyelitis – or ME/CFS --  on the lips and in the minds of doctors across the country. I'm asking NIH Director Collins to meet with any action to discuss and commit to an urgent action this year to achieve tangible and realistic outcomes for people with ME/CFS.

This urgent action should include immediate requirements for continuing medical education to alleviate stigma and get patients diagnosed properly. And it needs to happen right now -- today -- because people are becoming ill with ME/CFS right now, today. People are living and dying with ME/CFS right now, today. And I thank you for listening to emotional outcry. Thank you.

Do we have Carol?

Man:Thank you. Operator, do we have Citizen 7 here?

Citizen 7:Yes, I'm here.

Man:Go ahead.

Citizen 7:            Yes, I thank you for your comments. All of you who have spoken this morning, it is heart wrenching. I'm XX. I'm President of the Solve ME/CFS Initiative. And going back to an earlier discussion this morning, I do commend our sister advocacy group speakers, also confirm our collaboration. My observation has been that each of the advocacy organizations that spoken this morning -- as well as SMCI which I represent -- have taken on roles that are synergistic in their focus. Much time is spent behind the scenes and discussing among us. For instance, it's not by chance that millions missing occurred on a Saturday, followed three days later by SMCI's lead advocacy in the halls of Congress. They reinforced each other.

So my point is that we, nonprofit groups -- most of us working on a shoe string -- have been the driving force in moving this disease forward generally and also on (unintelligible). And I do welcome and honor those of you who are -- who sit on CFSAC and your positions to join us and becoming a driving force. You have power as representatives of the federal government that we do not. And we need you.

I have a question. I do thank you, (Vicky) Whittemore, for the update on NIH's extra mural programs. And I know, (Vicky), that you are not responsible for the intramural program. I do hope soon that the community will understand the progress of the intramural study involving those with ME and other control groups at the hospital at Bethesda. Just to go back a bit, we all understand the problems that can occur when research criteria -- for selecting those with ME – are too loose. And many people are studied are really are not appropriate in an ME study. And I'm confident that that is not occurring in the rigorous intramural study at the NIH.

And at the same time, research criteria definitions that are extremely tight can have a deleterious impact on finding a sufficient number of patients and therefore impedes study progress. (Vicky) – I wonder – do you know whether the ME/CFS community can expect to hear publicly from Dr. Nath and Dr. (Wallet) on the progress of that study? Thank you.

Man:Thank you. Operator, do we have the anonymous speaker?

Coordinator:     We do.

Man:Go ahead, please.

Woman:Good morning. Can you hear me?

Man:Yes ma'am.

Woman:Thank you. This month marks the end of my 40th year trying to survive ME. That's 40 years of NIH underfunding of ME research, 40 years of no available treatment, 40 years of overwhelming human apathy and negative bias that have robbed me of my right to live, not simply to be alive, but to live.

I know that you're not here today, NIH Director, Dr. Francis Collins. Nevertheless, I direct my testimony to you. While we're testifying about the unimaginable suffering that suffuses our daily lives -- and the lives of our loved ones fed by a tube and no longer able to speak or eat, caregivers who can only watch as any specific medical care and treatments remain nonexistent or inaccessible for us – I cannot help but struggle to understand how you can move so slowly and continued to underfund ME biomedical research by so many orders of magnitude.

HHS and its leaders have wronged me -- and more than a million other Americans with ME -- of our lives, our independence, our livelihood, our passions, our human connections and our dignity. Did you have a chance to read talented writer and former bodybuilder, Jamison Hill's, heart rending article in the New York Times last month? He shared that he has been sick with ME for the past eight years, the last three of which have been rent have rendered him bedridden, mostly unable to speak and unable to eat solid food.

He wrote, “I, on the other hand, have had to do everything in bed, brush my teeth, bathe and use the quote unquote bathroom, a plastic bag for bowel movement and -- for urinating -- a dubious looking plastic container attached to a tube feeding into a bucket on the floor.” This is so painful to read.

I don't share Jamison words to shock you, but rather to help you better understand the everyday lives of so many people with ME and why we require urgent action, urgent funding increases, urgent medical education and more. This is serious folks. Dr. Collins, your negative bias in hard heartedness continue to condemn hundreds of thousands of Americans to a mostly or fully bedbound life.

How can you not see what your refusal to equitably fund ME research has been doing to us? So many of our lives -- and the lives of our caregivers -- are a living hell. The center's grants are far too low. Brilliant researchers who have received hundreds of millions of dollars in NIH funding in other disease areas have been repeatedly denied ME funding to study -- denied NIH funding -- to study ME. You can increase funding for ME research, but so far you have refused. You have been ME's judge and jury, and our prison guard and executioner.

Your bias against ME condemns us to this living death year after year. Your actions have demonstrated that you need to respect more value the lives of more than a million Americans who struggle to survive ME and NIH's (unintelligible). This cannot go on, Dr. Collins, CDC, NIHS. You must act with urgency. You must end the cruel abandonment of -- at the very least -- your moral and ethical responsibilities to this large population of desperately ill Americans. There are no excuses or justifications.

The ME community requires that researchers use a consensus driven research case definition, which was called for in a federal report. Common data elements are a different animal and aren't enough. We all heard NIH's own Dr. Avi Nath proclaim or publicly comment on this subject when he said, quote, garbage in, garbage out. We agree. The ME community requires concrete, well-coordinated milestone-driven plans from NIH and CDC to proactively and aggressively reverse the stigma and the false -- but dominant -- narratives in the medical community.

Despite Dr. Collins' pronouncement two months ago that quote research done correctly takes time unquote. The ME community knows far too well that ME research requires equitable NIH funding, having lived with ME – and it's related medical abuse -- for the past 40 years. After all, I – and thousands of others -- have been writing to you about this for years while attempting to survive this manmade catastrophe, how much more time must it take for ME research to be done correctly? Why isn't 40 years enough time for research to be done correctly, Dr. Collins?

Without adequate and equitable funding, progress on ME cannot be made, answers cannot be attained. NIH has proven this beyond a shadow of a doubt.

Coordinator:You have about 30 seconds left.

Woman:You're interrupting me. Lying by omission is still lying. So please, Dr. Collins, stop lying to us. Lying is beneath the office that you hold and not one of the million plus Americans with ME deserves to be lied to by the director of the NIH. That is a level of disrespect that will never be acceptable. We don't deserve to live or die like this, Dr. Collins. Give people with ME a chance. What do you say?

Man:Thank you ma'am.

Woman:Thank you.

Man:( Citizen)8, operator?

Coordinator:(unintelligible). They said that was the wrong number.


Coordinator:Yes. One moment. (Citizen 9), you're line is open.

(Citizen 9):Okay. Can you guys hear me okay? Yeah, I can barely hear you. Well, that is a tough act to follow. And actually -- after listening to some of these comments -- I must tell you that there are people who are far more educated in the game than 99% of us out here who sit around and a doctor won't even let the term ME/CFS pass through their lips.

I'm in San Diego, California. There is no one here to help me. Interestingly enough, UCFD has got a small grant for a study of a medication. But no one in the hospital where I go is treating the disease. One of the things that I've observed is that it almost seems like the more information that comes out about it, the more of a backlash we were facing. I have been sick for 20 years and been through many, many doctors. And in the early days of the illness, they were much more concerned about making me feel better. They weren't sure what I had, but at least I could get symptomatic relief.

As it states in my email, what I'm starting to realize is that we are a pariah now. Now that this issue is above the water and there is talk of research and the bantering about with nomenclature. Where I am finding trouble is that if I tell a doctor what medication gives me symptomatic relief, if it is not indicated as an on label or appropriate use for that drug, I cannot get it. As it stands, doctors will tell me now that they cannot help me. I have an MRI of my spine. If they did not know I had ME/CFS, they would probably give me some symptomatic relief.

I had been given pain medication 10 or 12 years ago that they will no longer give me. I am not a malingering drug seeking person. I am a damn near 60 year old woman who is not going to go out onto the street and sling opiates. I can barely get out of bed. But one of the problems I am seeing is that reticence to any specialist, GP, internist -- or anyone that I go to -- is that they are not willing to treat symptoms.

Basic drugs like prednisone for inflammation, for flare ups, basic pain medications, drugs for cognitive, like I call it cognitive connectivity, but a drugs like Ritalin or Adderall is very helpful for me because it helps me to coalesce my thoughts and I cannot tell you how many times that I have been denied just basic symptomatic relief.

I'm of an age now where I don't really -- even if there is investigation and a blood test, by the time the miracle drug are those things happen, my life is going to be over. All I am looking for is simply some quality of life. And it seems like the more notoriety this disease gets -- and the more focused we get on doing medicine by the numbers or by the test rather than listening to a patient symptoms and saying, I don't know what you have, but maybe I can improve the quality of your life -- some of us wouldn't be so angry and despondent.

We get – there are no doctors that I can see. I have yet to fly to San Francisco for an appointment a year and a half from now to get to be seen at Stanford. This is absurd and we're not asking for the Moon. And many of us are just asking to feel better – that's all – and to be heard. But man, I don't know if it's ego, I don't know if it's the word that comes down from administrative control of these medical centers that they can't even speak the word.

They can't even write ME/CFS on a piece of paper. It is almost like they'll be signing a contract for some sort of upcoming -- you know, it just seems like there is such a resistance, but it's not based on anything other than the ego bias and possibly litigation. I can't figure out why I can't get simple symptomatic relief. And I'll leave you guys with that, but while you're chasing the big things and the big issues, for the majority of us out here, we just want to feel better. That's it and that's all I can tell you. Thank you.

Man:Thank you.

Citizen 9:Thank you.



Man:Go ahead, sir.

(Citizen 10):Good afternoon. My name is XX. My adult daughter has been ill with ME for over 12 years, since age 15. My frustration is the total lack of urgency by NIH to fund ME research a meaningful amount. (Unintelligible) 2016 Burden of Disease Analysis suggested an annual funding level of $188 million.

This committee recommended in August 2015 that based disease prevalence, equitable funding is estimated to be $250 million per year. Dr. (Portershef) at NIH, stated in the July 10, 2017 ME/CFS Advocacy Call that we totally agree that the amount of funding for ME/CFS research is not even close to the burden of illness. Let me repeat, Dr. (Portershef)'s statements. We totally agree that the amount of funding for ME/CFS research is not even close to the burden of illness. Why not? Has NIH commissioned a burden of disease analysis of ME? What were the results?

If not, I believe one should be done immediately. I believe it is impossible to make correct decisions regarding ME research funding without a burden of disease analysis. The daily life of ME patients revolves around this illness. ME is a public health crisis that needs to be solved. I recognize that NIH receives too few ME research application. In the July 10, 2017 ME/CFS advocacy calls, Dr. (Portershef) stated, "I agree totally that this field needs a greater incentive to get people in.

This lack of urgency by NIH -- to provide the incentive to attract additional ME researchers -- negatively impacts my daughter and all who suffer from ME. What has NIH done since then to change this situation? What does this committee think should be done? What are the specific actions and incentives that this committee believes NIH needs to take to stimulate ME research?

It seems to me that NIH is faced with this conundrum that NIH is unwilling to fund RFAs until they seem more interested in ME research. And you won't see more ME research interest until NIH funds RFAs. NIH has the power to change this.

If NIH was able to form 30 new partnerships in 10 months to find new addictive treatments and alternatives to opioids, it should be able to put forth the same effort to solve ME. It is essential that NIH assume the responsibility to do whatever is necessary to stimulate ME research. NIH must think creatively about the proactive steps that it can take to raise awareness, equitably fund and encourage research to solve ME.

I request that this committee recommend to Secretary Azar, that the following actions be immediately implemented by NIH. One -- commission a burden of disease analysis of ME. Two – increase ME research funding based on that finding. Three – stop justifying the lack of funding based on a low number of ME research applications and assume the responsibility to do whatever is necessary to jumpstart and stimulate ME research.

Four -- adopt the specific actions and incentives that this committee believes NIH needs to take to stimulate ME research. Five -- recognize that ME is a public health crisis and act accordingly. Solve ME. If these actions have been taken 12 years ago, hopefully my daughter -- and all other sufferers -- would not be ill today. Thank you.

Man:Thank you Mr. (Mills). And the last speaker up to for the hour, (Jennifer Spatella).

(Citizen 10):Yes, I'm here. Is my line open?

Man:Yes, go ahead, please.

(Citizen 10):Thank you. My name is XX. I'll soon begin my 25th year of living with ME. People with ME know this disease. We have valuable insights and perspective -- not only about what it is like to live in an ME afflicted body -- but about the scientific and medical issues in this field. This is one reason why I am so encouraged that this field is beginning to engage people with ME as partners because we can teach you. I've had unique opportunities to learn how to integrate people affected by this disease into research and policy making.

When I served on the board of the (unintelligible) Association, I reviewed grant proposals for strategic merit. I'm an ambassador for the Patient Centered Outcomes Research Institute. I participate in the FDA's Patient Representative Program.

I served on this committee's stakeholder work group, and last year I co-authored the paper, Engaging People with ME as Partners in the Collaborative Research Centers, which is featured on the Faster Cures web site, as well as ME Actions. I list these qualifications to provide you with context for my comments today. NIH and CDC are just beginning to engage us as partners. The NIH common data elements project for ME/CFS included people him, ME/CFS included people directly affected by ME on each of its work in groups – a first for the CDE program.

CDC has collected input from stakeholders for its web site revisions, although the focus group format is not as substantive as it could be. And for the first time in our field, NIH's RFA -- for the collaborative research centers – required that applicants have a plan for outreach and partnering with ME/CFS stakeholders. These are steps in the right direction, but I have questions relevant to this committee's advisory role.

Funding for the collaborative research centers and data management center began nine months ago and work is underway. But not a single center appears to have a functioning community advisory board.

What is NIH going to do to ensure that the centers follow through? Will NIH require stakeholder engagement in all of its ME/CFS grants moving forward? What about the intramural research including Dr. Nath's study? What efforts are CDC and NIH making to ensure a diversity of views? Reliance upon one or two organizations -- for the pool of stakeholders -- is certainly easy and convenient for the agencies and the research center. But no single organization can provide the full breadth of experiences and views that are needed in each engagement effort.

What will NIH do to engage people with ME in planning the April 2019 meeting on accelerating ME/CFS research? How will NIH ensure that people with ME will be substantively involved in all of its own advisory groups and committees on ME/CFS research, including the newly announced NIMBH councils, ME/CFS working group. CFSAC must do more than ask these kinds of questions of the federal agencies.

In January 2017, this committee received a report from its own stakeholder work group and voted for the work group to continue developing recommendations. But as far as I can tell, nothing happened. The work group seems to have fizzled. As a result, this committee has not made a single recommendation to the secretary on how HHS agencies can effectively partner with people with ME at every stage of research and policy making.

This is a significant lost opportunity. Every person with ME is a fount of knowledge that should not be ignored. Partner with us, and we will make your research and policy efforts more relevant, more accurate, and more successful. But we are not window dressing. Engaging with us is not a box to be ticked. It is a scientific and ethical imperative that people with ME would be engaged as true partners and equals with everyone else on your team or committee. Anything less is unacceptable.

I urge this committee to restart the efforts of the stakeholder work group and help lead the way towards fully integrating people with ME into both research and policymaking. And I urge you to ask tough questions of the federal agencies to better understand how they will engage with us as well. Thank you.

Woman:Thank you for your comments.

Man:Thank you. (Faith Newton), I'm going to turn it over to you now for any (unintelligible) discussion of the comments among committee members.

(Faith Newton):Okay. Committee members, some questions that were directed at the officials. I don't know if you want to answer them first. We also, I would also want to hear from the voting members (unintelligible) members about the comments. We've got about 15 minutes.

(Courtney Miller):Well, I can start. This is (Courtney Miller).

(Faith Newton):Yes (Courtney), go ahead.

(Courtney Miller):So I'm familiar with many of the comments that were made today. I know some of the people who made them. I was struck really by the duration that almost everybody -- I think everybody -- who made a comment, almost everybody was diagnosed -- or their loved one was diagnosed - than 10 years ago. And, I personally can mark this time.

This past week. (Bob) and my twin boys graduated from high school. They were born when (Bob) started (unintelligible). So the clock is moving way too slow on our actions. And I appreciate the emotion that takes to (unintelligible) the committee very, very publicly, stories that, you know, are really hard to live and hard to tell.

But I also feel like the folks who are coming to our committee have been doing this for so long and we can be, we can feel better about our work or feel good about of our work collectively on this committee and the agencies in our advocacy group, in our personal lives, if we don't have a whole new crop of people five years from now saying they've been diagnosed for 10 years and are going nowhere.

And so it takes time before people can get to the point where they come to us for help. So, you know, we have a, we have a heavy job and appreciate people who put their lives out there.

Woman:Thank you (Courtney) for your comments. Any other comments from other members?

(Cindy Bateman):(Unintelligible).

Woman:(Cindy Bateman), go ahead.

(Cindy Bateman):I just wanted to thank all the people who came and did the public comment and say that I'm, I resonate completely with the messages they gave. I agreed with all of it and support it. I wanted to make a more specific comment about two things. One is that, the, the man from Michigan -- I'm sorry I missed your name when you were in public comment -- but Dr. (Marin Learner) is the doctor that died who had been taking care of numerous patients.

He served on the IOM committee that produced the ME/CFS clinical diagnostic guidelines. And I can tell you personally that many, many patients from that area have contacted my office and other places trying to get medical care. And I spent about 18 months trying to help one patient -- who's homebound -- establish with a primary care physician.

And we went through at least four primary care physicians. And this is with personal contact by me sending medical records, really sending educational materials and we still don't have a primary care physician who can manage this homebound patient with a severe ME/CFS.

The second – oh and it's – I think most people don't realize that when it comes to telemedicine, but were unable to practice medicine outside our own states because of laws around licensing and malpractice. So it's really critical that patients find a primary care physician where they are, because otherwise they have to travel. The second thing I wanted to say is that I also agree and want to make a public statement about this for the record that I believe early diagnosis and appropriate management is highly likely to alter morbidity and prognosis. And I just want to validate that. And that comes from my own clinical experience. Thank you.

Woman:Thank you, (Cindy Bateman). No other comments? Anybody else want to speak?

Ben HsuBorger:(Unintelligible) something what Dr. (Bateman) said. (Unintelligible) showed comments and others. There are many concerns I have around the challenges we have with research, increasing the funding, improving the patient selection, having patients more involved in these, in the cabs with research centers. But on the other side of that, I think the public comments testify to, is we're having a crisis in clinical care.

And so the action from other organizations like we put out a directory list of specialists to refer people to and the list is shrinking, not growing. And as everyone's talking about the need to move forward with research -- which we want people to do--  you know, patient recruitment for all of that is going to come through physicians to understand the disease and conduct -- effectively diagnose it and treat it.

And so we're going to run into huge issues with trying to ramp up any program if we don't also address the clinical, the, the crisis or clinical care before it will affect – it affects patients now and affects our ability to change things for the future. And I wonder if any of the officials or reps have any ideas how we can come together as agencies and address some of these problems because the (unintelligible), I know that it's not within any of your narrow mandates, but it seems like a pretty stark problem that's at the center of a lot of things if we're going to make progress.

Woman:Thank you. (Ben). Any other comments from the group?

(Leah Williams):This is (Leah Williams) from (unintelligible).

Woman:Go ahead (Leah).

(Leah Williams):I agree with (Courtney)'s comment that it was striking that so many of the stories were from people who have been sick for decades. In my case, I have two kids who have been sick for 10 and seven years. And so we're the ones who have found CFSAC or are able to make public comments. But there are people getting sick now who --10 years from now -- I'm afraid will still feel like no progress is being made. And so I just second all the calls for a sense of urgency. They actually change things, get more research funding, get more clinical practice practitioners trained.        

That's all. Thank you.

Woman:Thank you (Leah).

(Faith Newton):Yeah I – this is (Faith Newton) – my son is 22. I have twins. My son has ME/CFS, my daughter does not. And my son got sick when he was 11. He's now 22 and never went back to school full time. And I also echo the comments and I wonder he is – he manages the disease really well but he – and he's got – he picked a career that he can function and go into what I call work (unintelligible) computers. But I wonder how long he's going to be able to keep up this career, you know, how long he can function at the pace that he's functioning at.

So I -- the stories and just the emotional really resonated with me. It is very – I wonder also, we have patients, we have kids that are getting sick now and are they going to be sick for 10 years in 15 years and 20 years. You know, it is very emotional. And I am glad that you -- all of our patients -- called in and that you tell us what you're feeling and what's going on. It is very difficult to listen to, but it is very important that we hear what you're saying. Any other comments from anybody that's on the committee – member, officials? Anybody else?

Woman:Okay, then let's move on. Let me pull up the agenda. I'm sorry, I got. Just give me a minute. Okay. Update from the Medical Education Work Group.

Man:I'm sorry (unintelligible), sorry to interrupt. Just before, could you clarify before the morning of the original agenda was going to be three agency updates and there are only two and I wonder when ARGQ. I that going to be tomorrow or later today (unintelligible) update?

(Ted Ganja):(Ted Ganja). Unfortunately it's no longer with the agency. We are in the process of identifying a new official. And the agenda was drafted and posted on the web site after the fact.

Man:Okay. Do we have a point of contact (unintelligible)?

(Ted Ganja):No. I'm…


(Ted Ganja):…trying to identify one.

Man:Okay, thank you.

Woman:(Unintelligible). So the next thing we have is updates in the medical education world. Before we have (unintelligible) and then after that we got (unintelligible) speaking about general pediatrics. I want make a comment about the working group, so I want to give everybody some background. We've had many, many years where this committee would make recommendations that could not be acted on -- many, many years of this.

As a result, working groups for created within the last couple of years where officials sat at the table with CFSAC members and -- most recently -- community members. The working groups conducted their research and out of the working group -- by consensus -- came recommendations. It takes time for this process to work, but when it works, it works very well.

I have heard repeatedly, we don't have time. But what we don't have time for is making recommendations that go unfunded and that (unintelligible) the advocate's time, the patient's time and the officials' time. And I guess I want to be very careful. I have probably two rules -- that we that we listen to each other and that we are very respectful of each other because in the end we want the same thing.

We want this to be treated. We want treatment for it. We want -- whether we're a patient ourselves, whether it's our children, whether it's our loved one -- we want them treated and we want people to get well. So let's start with (Cindy Bateman). (Unintelligible) up first?

(Cindy Bateman):Yes it is. Can you hear me OK?

Woman:Yes, I can.

(Cindy Bateman):Well thank you very much. I'm happy to represent the Medical Education Work Group as Chair. I also submitted a written document that can accompany these slides and hopefully either one can be available.

Man:(Unintelligible) web site (unintelligible) (Vicky). (Cindy Bateman), I'm sorry.

(Cindy Bateman):All right, next slide please. Before I start my comments, I just wanted to give the setting for the crisis and the important things that are required by quoting from the IOM report beyond ME/CFS redefining an illness. And we know that this illness affects more than a million people, that the majority aren't diagnosed -- at least not in a timely way -- that there's a large economic burden to our country. but most important -- and most relevant for this committee -- is that  education about ME/CFS has rarely included in medical curriculum in medical textbooks, and that patients are marginalized, stereotyped, often subject to -- not only improper care -- but hostility by medical providers.

And the one of the – the  number one recommendation in the IOM report was that a new coach would be assigned to ME/CFS in ICD 10 that is not linked to chronic fatigue or (unintelligible). So with that in mind, I want to move ahead with my report. Next slide please.

So our medical education work group -- just want to let you know -- we met five times as a group. We had a visit and presentation from the project Echo. This is not in the slide. I'll get to this in a minute. And we also had one other Echo subcommittee meeting. So a lot of work went into our report. And these are the major things I want to report today. Some of them are going to take more time, some less. One is a discussion about ICD 9, ICD 10, ICD 11 coding.

I'd like to provide a brief report of the clinician summit, refer very briefly to state level initiatives and federal levels initiatives because most of those are going to -- have been reported separately and then wanting to focus on an idea that this -- our committee pursuit -- about tele mentoring and especially exploration of a specific project called Project Echo as efficient cost effective method to disseminate ME/CFS medical education. And then we will provide our workgroup recommendations to the CFSAC. Next slide please.

So, just a brief background. ICD 10 and definition so we can understand it, but if the term after ICD 10 is CM, that implies these are the US -- United States diagnostic coding. So the first slides I'll be talking about what we think are some of the dilemmas with our ICD 10 coding and in the second slide about ICD 11. So, and then WHO -- the World Health Organization -- has their own set of ICD codes that are used more internationally and generally WHO formulates the policy and the codes and then the US codes, the CM codes follow.

And ICD 10 – WHO ICD 10 – has classified ME/CFS and post (unintelligible) syndromes in the neurological chapter G93.3. In the US ICD 10 coding -- which was implemented in February of 2016, not February, so at the end of 2015, so in the same year as the IOM report -- the code for CFS, the ICD 9 code for CFS -- which was in the symptoms, signs and ill-defined conditions, but at least we have our own code of 780.7 – in ICD that disappeared.

And in an ICD 10 was implemented by all clinicians that toward the end of 2015. And the default if you put chronic fatigue syndrome in, went to chronic fatigue unspecified, which is in the general symptoms and signs. So it did not follow what happened in the policy in WHO ICD 10. And this is a very big crisis for clinicians because in order for a clinician to code the diagnosis for insurance reimbursement for Medicare -- all those things -- they must -- if you put chronic fatigue syndrome into search for the code, it will go to chronic fatigue unspecified.

You have to know to search for post-viral fatigue or Myalgia encephalomyelitis. If you do that, it will go to the G93.3 code. But this is really only insiders who understand this and the general clinician community would not understand how to do this.

So over the course of years, three proposals have been sent to NCHS, the National Center for Health Statistics regarding these issues, particularly to move CFS back to the neurological chapter. And more recently -- definitely away from the even more nonspecific code chronic fatigue unspecified. The latest proposal -- which was part of it has been part of our recommendations -- was submitted by ICFS (unintelligible), Dr. (Lily Chu) in July and had – was rejected from consideration at  their planning meetings in September 2017 and March 2018.

So we as a group had a chance to meet with Donna Pickett and talk to her and we're waiting to hear - and also (Gustavo), was able to communicate with her and we're waiting to hear about whether the ICFS ME proposal will be added to the September agenda to discuss these changes in ICD 10. Next slide please.

This slide is now out of date, thankfully, because in this slide, we want to address WHO ICD 11 recommended. So recommendations, WHO ICD 11 was under development, but as of Monday, June 18th this week, the ICD, WHO ICD 11, program was released and for use. And CFS ME and post-viral fatigue have remained in the neurological chapter, which is very helpful.

When we met with Donna Pickett in our work group, she said they were waiting to see what would happen with ICD 10 because there was a proposal to move out ME/CFS out of the neurologic chapter. But now we know that it has remained in the neurological chapter. So we're hoping that that will help move the agenda along in the NCHS meetings and bring more clarity as to where these codes should be, which code should be used.

And again, after our communications, we're waiting for Ms. Pickett to review the document that we sent and to provide additional information for us about the plans for ICD coding in the US. Next slide please.

And I'm open to discuss these things afterwards because quite a few things in this presentation. Second is, I would like to report to you about the three-day expert ME/CFS Clinician Summit that was held in Salt Lake City in March of this year. Thirteen ME/CFS clinical experts were invited. Everybody who was invited came. This was done with private funding. There were a few invited guests and observers. And the goal of the summit was to lay a foundation for ongoing collaboration among the few existing ME/CFS clinical experts and also with an idea that we will collaborate and grow this group.

Second is to develop and disseminate ME/CFS clinical knowledge for medical providers, try to facilitate that. And third, the third goal was to try to share our clinical pearls and knowledge with researchers as they're developing their clinical protocols, their research protocols. Next slide please.

This is just a picture of the group at work and this was a very collaborative, open exchange of people's ideas and their experience. And it was a very exciting process for everyone. There is a short video that we -- that we made -- describing what was done in this a clinician summit and some of the very basic outcomes if anybody wants to view that at that length there. Next slide please.

The clinician summit was a very successful endeavor. We're now calling the group The Clinician Coalition. And the future collaboration anticipated -- and some of these are done already we've established a listserv for the ME/CFS clinical experts to share ideas -- we hope to establish and provide group consensus statements. We already did that with our consensus statement about (unintelligible) and CBT as inappropriate – or at least not primary -- interventions and helpful interventions for treatment of ME/CFS.

We have a goal to produce publications. We have -- we can be a resource for the echo project we should want to talk about sooner and then there is discussion about creating a clinical trials group so that as drugs become available or as opportunity and funding becomes available, we can more quickly initiate these clinical trials.

We plan on having group teleconferences to accomplish interval goals and yearly in person, clinician meetings. The next one is scheduled for March 2018 and our goal is to expand and strengthen collaboration to increase the number of ME/CFSs experts and hopefully we can host some chronic, some CME conferences in the future. Next slide please.

Before I go on, I just want to say that this kind of collaboration is a very needed, but very expensive. So we will be looking for funding avenues in the future to keep this a collaborative effort going with the expert clinicians. There are state level initiatives that have been discussed in our meeting today – very excellent presentations and discussions by (Ben), and by (Leah). We -- because (Terry Wilder) and Charmain were on our committee, I've listed some of the things that have been done here in New York state. Mainly this is to inspire others to take action.

We don't have to wait for a federal action on everything. We can start at a grassroots level and try to work with our state health departments. We, in Bateman Horne Center have also, we are a nonprofit, also done some similar things, with (unintelligible) followed by panel discussion. Some of those are on our YouTube website.

I also wanted to mention that we've been able to, take education about ME/CFS to the Board of Directors of the University of Utah Medical Center and also the board of medical directors of all of the University of Utah outpatient clinics. And we've also conducted two four hour continuing medical education programs.

We're also developing a six lecture series about management for patients that hope we've been implementing in person, but we'll also be able to get online. So with these efforts you can see on the screen -- and additional efforts -- I'm hoping that this will motivate people in many areas to create grassroots educational efforts. Next page please.

I also -- we wanted to recognize the federal initiatives specifically to create and disseminate ME/CFS, medical education. We'll hear from the CDC. They're working on multiple fronts. I know because I'm helping to design the Medscape CME that that's well underway. They've made changes on their web site, they're doing the round table and working on reaching out to some of the major providers of medical education material.

We've been told that the (unintelligible) of internal medicine will publish the 2016 addendum to the 2014 (unintelligible) ME/CFS evidence review. So hopefully that will come to pass. And then we're looking forward to a new representative to CISAC from HRSA because HRSA has an extensive tele mentoring experience in outreach to clinics and to many different programs throughout the country. Next slide.

So one of the main things that we spent time working on -- during our meetings -- was to explore a program of tele mentoring called Project Echo. Project Echo is a medical education program that is done remotely. And the goal of Project Echo is to unlock and share expert knowledge to increase the number of knowledgeable medical providers who can care for medically underserved populations. Now Project Echo has not been involved with ME/CFS, so this is a project that has been utilized to do, to provide good training to a physicians out in the community from experts in academic centers for a number of other illnesses. But we think it's a perfect fit for ME/CFS. And I'd like to describe why. Next slide please.

So these slides that are different color are borrowed from the slide deck that's available online from Project Echo. And the home base of Project Echo is at University of New Mexico. And they came to our group and really described all of what this kind of a project could do for an illness like ME/CFS in our outreach to train medical providers. Next slide please.

So Project Echo was started initially at the University of New Mexico to try to help patients -- with Hepatitis C – get access to expert care. So as the knowledge is moving forward -- and the treatment was improving -- some of the expert care was only available to people who could make it to large academic centers. So they designed a program to outreach to rural physicians, so that the experts could train the rural physicians in the management of Hepatitis C and provide expert care even if the patients come couldn't come into the academic centers.

As Project Echo has grown, it is applied to many other disease states. So in general, Project Echo is a lifelong learning, guided practice model that revolutionizes medical education and exponentially increases workforce capacity to provide best practice specialty care and reduce health disparities through its hub and spoke knowledge sharing networks.

So this applies -- this kind of education applies -- to people in need of access to specialty care for complex conditions,, conditions where there are not enough specialists to treat everyone. Echo trains primary care physicians -- or people in positions and outlined area all clinicians -- to provide these specialty care services. And then patients are able to get the right care in the right place at the right time. Next slide please.

So this is my slide. In addition, so in addition to sharing the best practice of medical care and reducing disparities, what the Echo model uses a case-based medical approach. So physicians -- or medical providers -- provide cases to the experts and the experts discuss the management, the diagnosis and management of these cases in learning in medical discussions.

They use modern technology to reduce the costs and monitor outcomes to measure the impact. And the study of outcomes in Hepatitis C showed that the outcomes, the care, the long-term outcomes of people with Hepatitis C in the rural areas, were just as good as those  who are able to come to the expert center for care.

So the model revolves around what are called hubs and spokes. And hubs are the experts who prepare and deliver medical education usually at an academic center, not always. And there are now 107 Project Echo hubs in the US addressing all kinds of medical issues. The spokes are the medical professionals that are far away from the experts learning in a remote setting, using technology in a virtual way. But in a live and interactive way. Next slide please.

So this, it's not the same as traditional telemedicine, which is a one on one management of a specialist with a patient remotely. And as I said, there are barriers to that as a, especially once you cross state lines, it would require the expert clinician to be licensed in each state that they're trying to offer medical advice to a patient. And also there are issues with malpractice coverage, not to mention that insurance very often doesn't cover telemedicine and there are some changes going on, but they're slow. So the Echo model is a, is what we call tele mentoring. And that is the hubs -- the expert hubs -- treat the outside clinicians and this can multiply the number of patients who were reached and strengthen the relationships with their primary care providers. Next slide please.

So again, these are still from Project Echo slides. These are not specific to ME/CFS. The Project Echo suggests that the best diseases are most appropriate diseases for this model, might be these good Echo candidates, diseases that are relatively common, diseases where management is complex, diseases with rapidly evolving treatments and medications -- have meaning it's hard for the physicians to keep up with continuing education or it's beyond what they learned in medical school -- illnesses with a high impact on society -- both health and economic impact -- and illnesses that have serious outcomes if they're not identified and untreated and illnesses that would have improved outcomes with better management.

And you can see from our discussion this, this seems like a perfect fit for ME/CFS. It fits right in with the goals of Project Echo. Next slide please.

This is a map of the United States. There are Echo programs all over the world, but not as many, but this is the map just showing the Echo hubs and super hubs in the United States. So the blue dots are all the locations of a hub that has some kind of a topic that is sent out and made available to medical providers for continuing education and to help share that expertise.

You can see there are only one, two, three looks like for states that don't already have an Echo hub, but remember, Echo is virtual. So a hub in any given place has the ability to reach anywhere electronically. Next slide please. 

So, our work group met with the specialists at Project Echo in New Mexico to learn about the feasibility. We also talked to them about the cost associated with creating an Echo. And I'll tell you in a further slide that we also spent time talking to the Echo -- that I spent time talking to Project Echo -- at the University of Utah. So very specifically the cost that would be associated creating and maintaining a Project Echo that would be specific to ME/CFS. For most Echo Projects, the average costs are about $100 to $200,000 per year.

But that's the average and they can range from a shoestring budget to a Cadillac budget depending on the situation. The funds -- those average costs -- cover program development, expert preparation and content delivery. And what's really great about Project Echo is that these services, per se, they are provided for free to participants.

So, those clinicians who were out, those folks who are receiving it, the Echo, the infrastructure of Project Echo is free, although, it's routine among all clinicians that sometimes there's a charge for continuing medical education credits, but it's usually nominal.

So this is a really cost effective way with the potential to reach an unlimited number of clinicians in the community if we can establish an expert based for a project echo hub. And I, we have been at Bateman Horne Center, been,  we applied for a grant, it's to see if we could get some funding for Project Echo.

And so we had the opportunity to talk to the University of Utah and come up with a sample budget. And we have, I've included that sample budget in the written report to CFSAC that has a little bit more detail about how these costs might be distributed. Next slide please.

So in general, our work group would like to make some suggestions about -- or at least discuss -- how we might -- how a Project Echo and support of ME/CFS – could be created and developed as a way to disseminate medical education because it's daunting to start from nothing and make something happen. So our recommendations as a work group or that an ME/CFS Project Echo should be started and it should be based at an academic center – a Project Echo site at an academic center.

There were some really good ideas about nonprofits and advocacy groups sponsoring Project Echo, but we decided as a group that the credibility, you know, we have this credibility problem with the medical institution and that we should come from an academically based program and then leverage partners with the federal institutions, the expert ME/CFS clinicians, perhaps even the NIH funded collaborative research centers, and then of course the advocacy groups and nonprofits.

We have a lot of resources, but we'd like to see if we can get a project started in an academic center. So, those resources are available. Second is in order for an ME/CFS Project Echo to be successful, there needs to be a strong marketing plan. How do we get physicians on the other end who don't know what they don't know and might not think they're interested? How do we overcome the bias, the lack of interest in resistance? And our group felt like, with the, with adequate resources we could, it would be possible to develop a plan to enlarge reach and resources.

And also project echo is designed, to do that. There's a marketing arm of Project Echo, there's communication among hubs, and there are classes and all kinds of things to train new Echo programs, how to market their CME programs and get people interested in attending. And then third, it would be important to seek and create federal funding to support growth and sustain an ME/CFS Project Echo as a primary route to dissemination of medical education. Next slide, please.

So just a word about my interactions with the project echo at the University of Utah. I contacted the program, the University of Utah is an Echo, a Project Echo hub. They currently have eight active Echo topics and I think their oldest topic was started within a couple of years of Echo an implementation in New Mexico.

I met with them -- both the medical director and the staff -- and they are very open to -- and welcoming -- to starting an ME/CFS project echo topic at the University of Utah. They're willing to implement this ASAP. It really just requires those resources that we mentioned the early slide. And would, at this point, the reason I can do this as I'm adjunct faculty at the University of Utah. Even though I work for the nonprofit, I also have adjunct faculty status. And so they're happy to leverage that status again and base this at academic institution.

And they are also welcoming to having accessing ME/CFS experts and researchers from all over the country to participate in the educational efforts. And honestly, I can tell you that there are many specialists -- at the University of Utah -- who are coming along understanding ME/CFS and embracing it and maybe a little bit more head of some other places. This is really just an exploration. Our committee did not make a decision about where Project Echo should be started. Next slide please.

So, in order to design and implement a project echo for ME/CFS, the following things would need to happen. There would need to be immediate funding staffing support. So at least half time staff person who would organize, organize the experts, help with content development. There would need to be reimbursement for travel and training for the staff and at least probably one expert. And then there need to be the initial expert preparation and delivery of these medical education lectures.

We think that there would also need to be the immediate funding staffing that, at, at least at Bateman Horne Center. Sorry. At least at Bateman Horne Center, we're willing to donate staff time to help in the short term, we're a nonprofit. But we'll also need a short term infusion of funds and talked about the possibility of maybe some of that funding coming from our advocacy organizations, as a way of an immediate jumpstart to get this program rolling.

Again, marketing will need to be very creative, but it can include the combined efforts of the larger project echo based in New Mexico, all the echo super hubs and our University of Utah Project Echo, but it could really be multiplied by help from federal agencies, nonprofits, patient advocacy groups in all the other ways that we can let clinicians know that these CME classes will be available through echo.

And then we're going to need development of sustainable funding sources. This will not be a onetime, a short term thing. This educational effort would be something that we would start small and build and grow and make bigger and bigger and that would require long-term financial support. Maybe a HRSA grant, a CDC budget item.

We're just brainstorming our committee. Of course, that doesn't have any oversight about this, but we'd like the committee to think about -- the larger committee -- about maybe where; could this more long-term financial support come from as well as the other questions listed above. Next slide please.

So this is the first time I described what echo stands for, but the echo, the, the acronym echo stands for expanding capacity for health outcomes. And actually at the end of 2016, the house and the Senate passed an act signing it and it was signed into law by President Obama that asked the secretary of Health and Human Services to study the impact of Project Echo.

And you can see the conditions here on, you know, how has, how could or how has project echo helped chronic diseases, mental substance use disorders, prenatal maternal health, pediatric care, pain management, and palliative care. And you can see that chronic diseases and conditions, the MTFS would qualify as there. And also to examine how a project echo has impacted implementation of public health programs, including those related to disease prevention and public health surveillance, etcetera and how this affects the healthcare workforce and how it impacts the delivery of healthcare in rural areas, frontier areas, health professional shortage areas, medically underserved areas and it and to medically underserved populations such as native Americans.

So we actually have an echo act that was passed by the house – the house and the Senate -- to ask the Secretary of Health and Human services to study the impact of Project Echo. And I think that ECFS falls within the description even though we don't already have a project echo. Next slide.

So because of Echo Act, our committee would like our work group -- the medical education work group – would like the CFSAC to discuss whether or not we could ask the Secretary of HHS to inform our committee about the study of Project Echo and how it might inform medical education for ME/CFS. And how could we explore -- or can we explore with the Secretary of Health -- how we might consider implementation of an ME/CFS medical education is the prospective way to study the impact of Project Echo.

We know that ME/CFS faults within the description of an appropriate disease for an Echo project. And this would be a chance to start from scratch, implement a program, and then assess its efficacy. Next slide.

So these are the recommendations from our work group, the Medical Education Work Group to CFSAC in this meeting. And we'd like to have them considered as recommendations to the Secretary of Health. Number one is CFSAC recommends that the National Center for Health Statistics work with ME/CFS experts and advocates to resolve concerns regarding the ICFS ME proposal about how to reclassify ME/CFS in ICD 10 CM and ensure that the ICFS ME proposal is placed on the agenda for the September meeting so that this can be discussed in an efficient way.

We also recommend that the CDC add a diagnostic coding section to the ME/CFSs website for medical providers to explain that the code for chronic fatigue unspecified -- or 53.82 -- should not be used for ME/CFS. This is in line with the IOM report and with all of the -- it's in line also with the WHO criteria.

And we would like to have this website, a section on diagnostic coding direct providers to use the existing code for Myalgia encephalomyelitis or post viral fatigue, which is G93.3 when coding the diagnosis of ME/CFS.

We also recommend that CFSAC recommend that all federal agencies providing ME/CFS information -- and outreach to medical providers -- should include this diagnostic coding clarification related to diagnosis of ME/CFS. It might take the ICD 10 committees a long time to make these changes -- and to publicize them -- and we have the ability to immediately explain to providers about how to use the appropriate diagnostic code. Next slide please.

So we -- our medical education work group recommends CFSAC that CFSAC endorse the establishment of an ME/CFS project echo or equivalent tele mentoring program to be conducted by ME/CFS disease experts and established during the existing academic center who host project echo. CFSAC recommends that the relevant HHS agencies including -- but not limited to -- CDC HRSA, HRQ, plus the VA and DOD actively support the implementation of an ME/CFS Project Echo development once established by meeting with CFSAC and or the medical education work group to identify potential funding mechanisms, grants, contracts -- anything that's be used to support the development, continuation and expansion of an ME/CFS Echo program for medical education  and also to identify and implement mechanisms to actively promote the project to the greater federal and medical community into encourage participation in these continuing medical education programs.

The mechanisms can include sending notice to medical professional societies and their members requesting the state departments of health information to their medical providers, encouraged encouraging staff at HRSA funded centers to participate in posting links to the program on each agency's website. And I would also add that maybe it would be something that social security could advise for their medical experts.

Okay. I think that is my last slide. So I would like to open for questions and discussion.

(Faith Newton):(Cindy Bateman), first question I have for you, this is (Faith Newton). Who was on your working group? I don't see that anywhere in (unintelligible).

(Cindy Bateman):It is on the written document. Let me just go and I will read it to you. So I was thinking that -- I forgot we were virtual and I thought we would all have a packet so I provide this Word document. so, the members of our committee were me, (Charmain Proscocower), (Carrie Welders), (Tina Pidmore), who took our minutes, (Goodwin Lange), (Donna Pearson), (Mary Demick), who helped me as my assistant with the agendas and with a lot of the paperwork, Carol Head, (Emily Taylor), (Ted Doniuts), (Beth Unger) and (Robin Curtis) from the CDC and (Engel Stovel) was also on our committee.

Woman:Who wants questions?

Woman:I just want to compliment (Cindy Bateman) on the amount of work that has gone into that and how effective those recommendations are. (Unintelligible) well done.

(Cindy Bateman):Thank you.

Woman:Other comments or questions?

(Donna Pearson):This is (Donna Pearson). I don't think I received the written version, the written supplemental version of report and would love to have that. And secondly, are we going to deal with the recommendations now, the way we have in the past?

Woman:Yes. We are, we are, yes. Remember, we learned that lesson several times, (Donna). We're going to deal with the recommendations now. I just wanted to know if there were any questions of (Cindy Bateman) before we got to the recommendations.

(Faith Newton):Yes. Especially are there any questions about project echo as viable – I hope there aren't – as  a viable vehicle for doing medical education, but also comments and questions about, you know, where people think it should be done, and how we might be able to generate the kind of funding needed to launch it and keep it going.

So that's why I asked who was out here working group. I wanted to make sure that (unintelligible), that somebody that the (unintelligible) there and thought that it was viable.

Woman:I think people were pretty excited about it.

(Faith Newton):(Unintelligible) excited about it, especially the cost. It was like, this is doable.


(Faith Newton):Yes, who is talking?

Man:     We have 4 o'clock to discuss these accommodations.

(Faith Newton):Right. It's (unintelligible). Well let's make sure there's no questions. We'll start with the recommendations.

Woman:I have one quick question. Do you know which academic centers are where echo is co-located which can be leveraged? 

(Faith Newton):It's (unintelligible) and it's on the Project echo website. It would be basically that map of the US that I put up. All of those centers have product Project Echos.


Woman:So here's what I'm thinking. We have a break at 3 to 3:15 Peter Rowe is on at 2:51. I literally was going to ask the need to start with our first recommendation. We'll knock them out one at a time, see if we can agree and vote on them one at a time. At 3 o'clock we'll take our break. We'll come back after Peter Rowe's presentation at 4 and finish the recommendations. Does that work for everybody?

Woman:Works for me. Can you go back (unintelligible)?

Woman:Yes. (Unintelligible) can you go back to

Woman:She got it.

Man:We also have – we've done in the past -- we have the document in Word. You guys want to reword it?

Woman:Right. (Unintelligible), can you change them?

Man:No, we cannot.

Woman:So I'm going to have to do it.


Woman:Wait a minute, let me bring them up. Or can you, let me ask you a different question. Syreeta, you can't bring up a blank slide, right? You need me to change them?

Man:No, no, no, (Faith Newton). We have these recommendations already in a Microsoft Word document. So as we have done in the past, we bring that document up, there it is, and make changes if you guys want to make change to the language. We've done this before, (Faith Newton), we're ready.

(Faith Newton):Okay. (Unintelligible) used to being 300 miles away or however far I am. Okay. All right, first one. (Unintelligible) recommends the National Center for Health Statistics works with experts. Why am I reading them? (Cindy Bateman), you read them.

(Cindy Bateman):We want NCHS to work with expert (unintelligible) to resolve concerns regarding the ICFS proposal about how to reclassify CFS in the ICD 10 CM codes and ensure that the ICFS ME proposal is placed on the agenda for the meeting in September.

Woman:(unintelligible). Going once, going twice. Everybody good? All right. I'm going to vote on them one at a time. And so it would be the voting members, which is myself. Donna, Cindy, Everett. Is Goodwin on?

Woman:Goodwin at last telephone contact she texted me.

Woman:Okay. (Unintelligible). All right. So all in favor of the first one say Aye.


Woman:Any opposed? The motion is approved. So recommendation one in the medical education group is approved. Second one. (Cindy Bateman)?

(Cindy Bateman):            Number two is the CFSAC recommends that the CDC diagnostic coding section to the ME/CFS web site for medical providers to explain that the code for chronic fatigue unspecified or 53.82 should not be used for ME/CFS and direct providers to the existing code for Biologic encephalomyelitis or post viral fatigue, which is G 93.3 when coding the diagnosis of ME/CFS.

Woman:Okay. I have a question. (Vicky), I know you're in the room. Do any of the officials – do you have any concerns about any of these? Because if you do, we need to hear from you. Everybody's okay?

(Vicky   Whittemore):     This is (Vicky). I'm okay.

Woman:Okay. It's really hard doing this by webinar because I'm literally staring at a blank blue wall.

(Christopher Tracy):This is Dr. (Tracy) from the DOD. I'll actually have to inquire about if this is a civilian, the only thing that pertains looks directly discusses the DOD involvement as item number five and using a civilian model to do tele med might have some conflicts with the types of privacy things we have in the military. So I'll have to look to see if we can actually do that or not.

I know we have something already that we implement this telemedicine, tele derm, I do tele room for all over the world for people that are deployed. And so we could very easily implement a mirror a thing that, that would, that would utilize that, but it might have to be something directly only involved for the DOD type service.

Woman:That's fine as long as it doesn't – what we're trying to get away from -- is that chronic fatigue unspecified should not be kept to code. That's the issue.

Man:Okay, but you're calling NIH for number 2. (Unintelligible) if you're on the line, are you okay with number 2?

Woman:Who are you asking (unintelligible)? No, it should be (Cindy Bateman). It's (Cindy Bateman)'s group.

(Christopher Tracy):Yes, yes and that (unintelligible) for the CDC.

Man:(unintelligible), can you hear me?

Man:Yes, we can.

Man:Yes, we actually were discussing this. My first reaction is may or may be difficult for us to do, but this is something that we, we need to huddle and talk about and see if they would allow us to put that on information on our website. So that's my first reaction. 

Woman:We could probably get a link over to NCHS.

(Cindy Bateman):Can I – this is (Cindy Bateman). I just want to say that this is not a controversial thing. We know that MEC CFS is not chronic fatigue unspecified the WHO coding uses G 93.3 in both ICD 10 and ICD 11. I think this was a glitch that was really not well understood and we either have to -- we have to educate all physicians to call this Myalgia encephalomyelitis or we're never going to be able to track this illness using ICD 9 coding if it goes in chronic fatigue, unspecified.

And it's a step back from the diagnostic coding in ICD 9, which CFS at least had its own code. It was in symptoms, but at least had its own code. Now we can't even track it as an entity, so we don't have to change anything. We just have to direct people to use the code they're not familiar with, which is the correct code.

Man:Right. I absolutely agree with everything you say (Cindy Bateman). And the best course of action is what you already recommended, which is the engage NCHS and other stakeholders and get this coding changed. And that would standardize basically for all practitioners start using the same coding. Putting on our website may get some people to use it, but you can't (unintelligible) rely on it.

(Cindy Bateman):You can't rely on it, but there's no way to -- we have to let clinicians know where the code is.


(Cindy Bateman):The existing code.

Man:Neither one is accurate. I mean, you would agree with me. The best course of action again, is to get it changed as well as soon as I can. 

Woman:I don't -- I don't agree that it's not accurate. If you put ME, if you put Myalgia encephalomyelitis in the search engine, it takes you right to G 93.3.

Man:This was done. I'd like to point out that the CDC response to our recommendation, which was the same back in August of 2015, they said, depending on -- this is the CDC response I'm reading from the web site. "Depending on the provider's documentation, CFS not otherwise specified, is an inclusion term under code R 5382, chronic fatigue, unspecified.

If the provider documents post viral fatigue syndrome or benign ME, then code G 93.3 would be assigned." So I think the CDC does agree with what (Cindy Bateman)'s saying. The question is, I'm hoping the question is can it be posted and can medical people be educated.

Man:Right. So (Donna), my response to that was we'll talk about it, see what we can put on our web site and get back to you.

Woman:Okay, that's fair enough. So let's make the lessons so...

Woman:we can make the recommendations to CDC.

Woman:Let's make the recommendation. Let's make the recommendation. We have two options. We could either hold off or make the recommendation tomorrow when (Beth Unger) us here or we could make the recommendations late.

Woman:No, I don't want to do that. We did that before. It was a mess. Let's make the recommendation. Let's see if everybody's in favor of it and then if we need to we can discuss it further tomorrow. Does that make sense?

Man:(Faith Newton), I sent you an email. (Beth Unger) will not be on tomorrow. She has been selected to be on a trial.

Woman:Oh whoa. She's not having a good two days. Okay. That's all in favor of recommending or (unintelligible), do you want to change this recommendation in any respect or is it fine the way it is?

Woman:I don't think changing it would be would make any difference. I've cleared the way it is. No. Okay. All right, so all in favor of a recommendation. Number two, say I. Any opposed? The motion passes as it is written. (Cindy Bateman), recommendation number three?

(Cindy Bateman):So recommendation number three is the same except it makes it more general to anybody who's posting ME/CFS information so we can get to more people and if CFSAC recommends that all federal agencies providing ME/CFS information and outreach to medical providers should include this diagnostic coding clarification related to diagnosis of ME/CFS.

Man:Question for new (unintelligible) DOD. Would this apply to you?

Man:I'm sorry. Say that again.

Man:Would recommendation number three apply to you or would the DOD have any issue with a number three?

Man:No, I don't think so.

Woman:Vicky and (unintelligible), would you have any problems with this?

Amos:This is (Amos). I am reading and thinking, just give me a minute.

Woman:Perfectly fine.

Woman:(Unintelligible) post what CDC has on their website (unintelligible) consistent. It's a question of how we are consistent in our educational material. I personally don't have a problem at all with this. That's just sort of the policy (unintelligible) in terms of educational information.

Man:How is number three different than number two?

Woman:                           Number two specifically says the CDC. Number three generalizes it to all federal agencies.

Man:Got It.

Woman:And this is a stop gap measure until decisions are made about...

Man:All you're doing is asking us to tell everyone to use the different ICD 10 code.

Woman:Right. As, as indicated by the IOM report and as agreed upon by most of the people or (unintelligible) with the disease.

Man:Yes. No, so...

Man:To make my job easier down the line, why can we not merge two and three?

(Amos):I was going to suggest the same thing. This is (Amos).

(Cindy Bateman):The reason – this is (Cindy Bateman). The reason I wouldn't merge them is the CDC is our destination for medical education. And if we lumped them and we run into problems with all federal agencies, then we're not going to be able to get the CDC to implement this on their website.

Man:So you want specifically target the CDC? Good thinking.

(Cindy Bateman):Any other, any other comments or concerns?

Man:     I just want to open -- I want to make sure that all the officials on the line are fine, are okay with number three. (Unintelligible) and I'm not sure if they...

(Cindy Bateman):Yes so is (unintelligible) on?

Man:Yes, is that (unintelligible) on the line?

Woman:Yes I am, I am here. (Unintelligible) what we do so I don't have (unintelligible).

(Michael):This is (Michael) from SSA. I think we are indifferent as far as diagnostic coding issues concerned.

Woman:So you're going to be OK?

Man:HRSA doesn't really have, I doubt that HRSA has any information on ME/CFS on their web site.


(Christopher Tracy):This is Dr. (Tracy) from DOD again. Maybe I'm just being over oversimplifying number three, but the way I'm reading this is just basically saying provide information to people that are using diagnostic coding, what correct coding is. You're not dictating how we provide that information or anything like that. It's just basically have something that provides information to our providers within DOD, correct?


Woman:Correct. Yes, that's exactly correct.

Man:But Dr. (Tracy), I'm not sure what that would entail changing something on your web site or (unintelligible) to let every (unintelligible) know at DOD how to do this.

(Christopher Tracy):Yes. I would perceive that we would let the surgeons general know or surgeons general know and let them dictate how they provide information. And that probably would just strictly be through an informational release or something like that. I don't think it would necessarily be on a website. There wouldn’t be any necessary training, and that's just through my past history of actually getting information from the different services.  I request information through their offices and they figure out how to get me that information.

(Gustavo Ceinos):Okay.  Because you're new to this process and what's going to happen after this is each agency is going to respond officially to these recommendations.  So I want you to be ready to have your response explaining in as eloquent a manner for the public to see on the (unintelligible) website.

(Faith Newton):And then in December, we'll be asking (unintelligible) that response at the live meeting.

(Christopher Tracy):Right, that would be the implied tasking.  Got it.  I understand.

(Faith Newton):Okay.  Yes, that's why we keep asking are you okay with it.  So (unintelligible). 

(Christopher Tracy):I'm okay with it right now until I start talking with other people and realize that I'm not okay. 


(Faith Newton):Anybody else with any other ex officio comments on Recommendation 3?  All in favor of Recommendation 3, say aye. 


(Faith Newton):Any opposed?  Recommendation 3 is approved as written. 

(Gustavo Ceinos):Funding is before missed participation. 

(Faith Newton):Oh, you're right.  Sorry, I kept going. 

(Gustavo Ceinos):We can finish 4 and 5 at 4:00.

(Faith Newton):We're going to finish 4 and 5 at 4:00.  Really, how about 3:20?

(Gustavo Ceinos):You're not looking at the agenda.  Peter Rowe is coming at 3:15.

(Faith Newton):I know, can we start him five minutes late?

(Gustavo Ceinos):You're the chair but…

(Faith Newton):No, I hear the hesitation.  Okay, we'll start on time.

Peter Rowe:(Faith), it's Peter.  I'm fine with that. 

(Gustavo Ceinos):I don't want to speak for him. 

(Faith Newton):Okay.  Peter, are you fine with us starting at 3:20, although they're probably going to be upset with me at (DASH)?  Because everyone loves to listen to you.

Peter Rowe:That's all right.

(Faith Newton):All right, 3:20 we'll start with you at 3:20 and thank you.

Peter Rowe:Okay. 

Coordinator:Welcome back and thank you for standing by.  I would now like to turn the conference over to Ms. (Faith Newton).  You may begin. 

(Faith Newton):Good afternoon.  We are going to listen to Dr. Peter Rowe, Professor of Pediatrics at Johns Hopkins University School of Medicine.  His specialty is in pediatric ME/CFS.  He's also one of the authors of the primer on, again, pediatrics that just recently came out and he is going to give us an update on research in pediatrics.  Go ahead, Peter.

Peter Rowe:Very good.  Can you hear me well on this speaker? 

(Faith Newton):Yes, you're good.

Peter Rowe:Okay.  Well, thank you, everybody, and thank you, (Faith), for the invitation.  (Faith) made a terrible mistake in not giving me too many guidelines when she said I could talk about pediatrics ME/CFS research and so I've selected a couple of papers that I think we can go into in some detail, that I think have really helped solidify information about the illness, and then also one that we did that I was excited about at our center. 

So if we could go to the next slide.  That's just the disclosure that I don't have any relevant financial relationships with anything we will be talking about today.  The next one gives the highlight or the overview of the talk.  And what I've done is just picked a couple of the papers published since the large literature review that we did as part of the IOM report.  One paper will talk about the impact of pediatric ME/CFS.  A second will present some new data on cognitive difficulties in the illness, and that third is the work that we've done on milk protein intolerance as a practical contributor to symptoms, something that we can - that will help us change treatment.

The next slide, as (Faith) mentioned, just wanted to bring to people's attention this open access primer for young people, which was put together by a group of international experts, pulled altogether by Rosemary Underhill, Ken Friedman, and Alan Gurwitt.  They invited the rest of us to join in this effort to come up with the equivalent of the adult primer that's available through the IACFS ME.  And we met for a couple of years every week or two by phone and conference, exchanging drafts and suggesting changes.

And the result that came out last summer is something that we think will be a very useful resource for physicians who are new to this field and are working with children and young adults with the illness.  We think it will be helpful for parents as well and we really wanted to emphasize that this was a practical document that would include tips on how to take history, how to divide up the appointments if it was a busy general practice, what things to look for on the physical exam, ways that you could distinguish ME/CFS from other fatiguing illnesses, some suggestions about lab studies.

And then a lot on practical strategies for looking at how you treat specific symptoms like headaches, pain, menstrual dysfunction, insomnia.  The other thing that we included, and we had input from Marvin Meadow and Julian Steward especially on this, was efforts - information on diagnosis and management of orthostatic intolerance since that's such a big part of pediatric ME/CFS.  And that includes advice on postural counter maneuvers, compression garments, medications, diet, and that sort of thing. 

The physicians in this group also wanted to incorporate some techniques about how to advise gradually advancing exercise without triggering post-exertional malaise.  We had information there about how to deal with the ups and downs and function.  Faith contributed a lot to the sections on educational accommodations and the primer even includes sample letters that pediatricians, and family physicians, and nurse practitioners can use as a model for how they communicate with the schools.

So we think this is going to fill a nice - a big gap in the literature and be a nice contribution that should help children in a variety of countries.  It's now being translated into several languages.  And Rosemary, and Ken, and Alan have been working on a e-book version of this that we hope will be available soon on Amazon. 

So with that as an introduction, let's go onto the next slide, which is about impact of pediatric ME/CFS.  The next slide just mentions that -- if we could go one further -- we've known for a while that pediatric ME/CFS is a common cause of prolonged school absence.  That was from the work of the Dowsett and Colby in England, published in 1997, and confirmed by a number of other groups.  But some of these studies looking at the overall impact of the illness on health were relatively small.  Some didn't really look at full-blown pediatric CFS or ME.  They looked at pediatric chronic fatigue only.

The biggest of the studies was won by Gwen Kennedy and colleagues.  They evaluated 25 children recruited from support groups in the United Kingdom, and they measured health-related quality of life using the child health questionnaire.  Of these children, only one of them attended regular school classes, 12 attended part-time.  So it was a fairly impaired group and compared to controls, who were healthy, the CHQ scores for the ME/CFS group were lowest on their global health, their physical function, and their role and social limitations due to physical problems themselves.

And these results were interesting because they were lower than the published work on children who had asthma or diabetes.  Very similar to the findings that Tony Komaroff  and others had reported in adults.  But there are couple of problems with this study.  One was it that it was affected by the bias of who responded to the questionnaires, and it was relatively small.  So the questions that were raised about the representativeness of the sample and whether this could be the same kind of impairment and quality of life in other countries. 

So the study I wanted to focus on today was done in Norway.  Next slide.  This was a paper by Winger on health-related quality of life in adolescents with CFS.  And the objective was to look at quality life and depressive symptoms in adolescents with the disease and compare the health-related quality of life and depressive symptoms with a group of healthy Norwegian adolescents.

And the study hypothesis was that adolescents with CFS would report lower quality of life and have a higher degree of depressive symptoms, fairly straightforward hypothesis.  The next slide points out that the methods of this study were that it was actually conducted in Oslo, in the capital, and it was referred to as the Nor Capital Study.  It was in part recruitment for a randomized trial of clonidine that these authors completed.  So it was at a national referral center and all of the pediatric departments in Norway, in the hospitals in Norway, and the primary care practitioners were invited to refer adolescents who met criteria for CFS to the study.  And the design for this part on quality of life was that it was a cross-sectional study of the adolescents who were engaged in and enrolled in the trial, recruited over two years, and then healthy controls from the local schools.

Next slide points out that they used a rather broad definition of chronic fatigue syndrome as they’ve done in all of the research from that group, which is Vegard Wyller's group in Oslo, where they insisted on fatigue lasting at least three months, plus functional disability resulting from the fatigue to a degree that prevented normal school attendance.  There is no - they couldn't have any other disease that would explain the fatigue and they couldn’t be on any medications that would interfere with the other study measures.  And because they were doing a trial of clonidine later, they excluded patients who had bradycardia or hypotension at the beginning.

Next slide shows the measures they used for the quality of life.  And the first one is the PedsQL, which is a simple one pager, has 23 items that it asks about, scored on the scale of 0 to 5, never a problem to a lot of a problem.  And there's some calculation that changes the overall total score to between 0 and 100, with 100 being the best you could be.  And from this, you can generate a scale of physical function, school function, social function, and emotional function, and then the last three are combined into the psychosocial score.

And so this gives you scores that are fairly similar to what the SF 36 measure can generate.  They also used a mood and feelings questionnaire, which had 33 items with scores greater than 20 suggestive of depression.  The next slide shows the results.  You can see that this was -- there were 120 with CFS. So a fairly large study for this field and they had 39 healthy controls.  Age and sex were similar.  The disease duration, even though they only required a three-month period to meet criteria for CFS, the mean disease duration was 21 months, and only two of them had a duration between three and six months.  All of the others were longer than six months.  And 74% met the Fukuda criteria.  So they had a substantial proportion of these who would meet these criteria that other studies have used.

When they looked at the percentage of school absence, the kids in the CFS group were missing about 30% of the days on average compared to 7% in the healthy group.  They did have higher scores on the mood and feelings questionnaire with 39% having a score of over 20 versus just 8% in the healthy group.  And we will come back to that issue in a second.

The next slide shows the real money shot of the health-related quality-of-life scores.  The total PedsQL score, mean score was 49 for the CFS patients and 93 for the healthy patients.  Remember, this is a scale that goes from 0 to 100 with 100 being optimal.  The worst of the scores was for physical function, or school function, and those correlate nicely with one another on - in other studies in this illness population.  The emotional and social scores were less impressively lowered in the CFS than the physical function score. 

The next slide gives you a graphic of how the CFS patients on the bottom compared to the scores in the healthy children on the top.  And you can again see that physical function and social function were relatively lower than emotional and social functioning.  Next slide, so they found that in the healthy kids, they were similar to other healthy controls in the Norwegian study.  So they felt that the healthy patient results were representative.  Girls with the illness had five points lower quality-of-life scores on the PedsQL than boys did.

There was an eight time greater risk of depressive symptoms in the CFS patients and higher levels of depressive symptoms were inversely associated with higher levels of health related quality of life in both CFS patients and healthy controls.  And that's a somewhat complicated way of saying that depression affected quality-of-life in the CFS patients and the healthy controls, but when they did their logistic regression analysis, there wasn't really a substantial change.  And they felt that being a patient and having depression were independently associated with quality-of-life.  So they concluded that the lower health-related quality of life was primarily explained by the illness and not by the depressive symptoms. 

So the next slide just points out that this is a large sample of adolescents.  It confirmed the findings from the Kennedy paper and other smaller studies, and was very similar to the reports in adults.  The authors conclude that this is seriously disabling condition that has a strong impact on health-related quality of life.  And in fact, they mentioned in the paper that health-related quality of life was poorer than they had expected.

Next slide just talks about a couple of limitations.  One is that there must've been some selection bias as only the children who could travel to Oslo for the study were included.  And we can't extrapolate these results, as is often the case with most studies to the most seriously affected patients.  They had a relatively high proportion who had depressive symptoms and that is possibly related to the lower cutoff value for scores on the MFQ.  And it may not be truly reflective of true depression. 

I think we need to see if those who met the Fukuda criteria, and the 26% who did not really differed on these questionnaires.  That would be something that would be interesting to see.  But as you'll see on the next slide, other studies now confirm fairly similar PedsQL scores.  This is a study from the Australian group, as paper by Knight and colleagues, and their total score for the PedsQL was also 49 in these 42 Australian children.  And notice as you go down through the list that the results between the two countries were rather similar.  Our results on this score are also in the same ballpark. 

So I think we now have - and this is appropriate during the era of looking at common data elements.  We have a fairly good measure of quality of life for children with this disease and it clearly confirms the same kind of level of dysfunction that we see in the adults.

The second paper, let's go to the next slide, is on cognitive difficulties.  And just by way of introduction, the next slide brings out some information from the IOM report where we found that in study samples and clinical samples of those who had pediatric ME/CFS, when the patients were not selected on the basis of a greater difficulty with their cognitive tasks, usually the results of baseline neuropsychological testing were similar to those in healthy controls. 

And this was puzzling because the self-reported cognitive dysfunction is a major part of the illness.  This finding in pediatrics is not that dissimilar from the adult.  Abnormalities would emerge on cognitive testing if participants were selected because they had increased difficulty with memory and concentration and more convincingly, if they had complex challenges that were employed, such as the one that Julian Steward's group did, where they combined orthostatic and cognitive stresses. 

But the field needed further exploration of this issue.  So the next slide points out that in general, there's been impairment in attention, immediate recall, different kinds of auditory and spatial memory, motor skills, and interference control, which refers to difficulty maintaining focus on a task when there's some interference from outside.  Most of the studies that reported this, though, were pretty small between sample sizes of between 9 and 34.

So the next slide points out that this is another paper from the Norwegian group where they use this large cross-sectional group that they were studying in the other paper.  And they wanted to characterize cognitive function in a large group of adolescents with CFS and compare that to healthy controls.  They wanted to explore the impact of anxiety, depression, and sleep problems on the cognitive features. 

The next slide shows you that this had the same design as we talked about in the other paper from the north capital project.  What they used as measures were the Karolinska sleep questionnaire, the same mood and feelings questionnaire, a behavior rating inventory of executive function called The Brief, and executive function is really the ability to look at higher-order cognitive functions and thinking.  And they did a cognitive battery, which included 40 minutes of testing in the clinic.

The next slide goes through these.  I'm not sure how well that projects, but they looked at elements from well-established neuropsych studies, looking at working memory, processing speed, the color word interference tests, or cognitive inhibition, where they would read aloud the name of the color that was printed in a different color.  They could - they had to switch between reading colored words and naming the ones where the word itself might've been printed in a different color than it really represented.

They did some verbal learning where they had to repeat 12 words aloud in three trials, verbal delayed memory after a 20 minute delay, and then the parents completed that questionnaire. 

The main findings are shown on the next slide and they showed that in the chronic fatigue group, which was 120, compared to the ones who met the Fukuda criteria, which is an N of 88, and then comparing those to the healthy controls, the biggest differences between the chronic fatigue - sorry, the chronic fatigue group and the Fukuda group really didn't differ substantially on any measure.  And when you compare the chronic fatigue group to the healthy controls, they had the biggest problems with processing speed and working memory.  And the parents also scored them very differently on the brief questionnaire. 

So the next study, or the next slide shows you the conclusions that the adolescents with chronic fatigue or CFS performed worse than healthy controls on measures that are listed here.  And when controlled for in the statistical analyses, they found that sleep problems, depression symptoms, and anxiety traits really didn't change the findings at all.  The sub group that met the Fukuda criteria didn't differ from those who met their broader definition of chronic fatigue on the cognitive measures. 

And so the next slide talks about some of the benefits.  One of the things is that unlike the earlier studies, this one had the sample size and the statistical power to identify these clinically important and statistically significant differences between children with CFS and the healthy adolescents.  And in fact, the authors went on to speculate that the test conditions in the trial might have underestimated the cognitive problems in CFS because they were in a quiet room, rather than say a school rom.

It is clear that repeated testing, tests that involved a longer period of stress tests following a period of exertion or physical exercise challenge, or those associated with orthostatic challenge all have the potential to even accentuate these differences further. 

The next slide, I just wanted to go onto the milk protein intolerance.  This is was something that we had been working on for a while.  Next slide.  We know that allergies and food sensitivities are often described as being much more common in those with CFS, but the studies looking at allergy usually focus on the IGE mediated reactions, using skin testing or rash testing, and very little of the work has focused on delayed or non-IGE mediated reactions.

But in the clinical care of children with CFS, working with Dr. Kevin Kelly, who is a pediatric gastroenterologist who did the first major paper linking food protein reactions to eosinophilic esophagitis, we had noted that a lot of the patients had an apparent increased proportion with signs and symptoms of a delayed reaction to milk protein.  So in our cohort study, we wanted to look at this more carefully.

Next slide next shows that the objective was to examine the prevalence, clinical features, and influence on illness severity of cow's milk protein intolerance in our patients with CFS.  Next one, next slide shows that this was in our tertiary care referral clinic and we compared the adolescents and young adults with CFS who were participating in a two-year cohort study where we were evaluated them, treated them, and followed them for two years.  And the eligibility was that they were between 10 and 23 years.  They met the Fukuda criteria and these were consecutive patients that came in over a four-year span.

Next slide.  We did a structured history and physical exam.  We used some of the same questionnaires as you heard about earlier every six months, including the PedsQL, the PedsQL fatigue scale, and then the functional disability inventory, which is another one that's very good at measuring dysfunction in this population.  All of the patients received multimodal therapy, whether that was medication directed symptoms and orthostatic intolerance, physical therapy, or other things.

But what differed in the group where we suspected milk protein intolerance is that we removed milk from their diets.  We didn't take everybody off milk.  Next slide.  Those who we suspected of having milk protein intolerance had to have at least two of the three symptoms that Dr. Kelly had first identified among the patients with eosinophilic esophagitis.  Those were gastroesophageal reflux, early satiety, and either epigastric or abdominal pain. 

They then had to have improvement -- if they had two of those three symptoms and they went on the milk free diet -- they had to have an improvement in their G.I. symptoms and at least two recurrences of their upper G.I. symptoms following re-exposure to cow's milk protein.  And because we are interested in this delayed hypersensitivity, they couldn't have any evidence of immediate or anaphylactic reaction to milk protein.  So by delayed, we mean at least a two hour delay between milk exposure and symptoms.

Next slide shows a flow diagram.  You may or may not be able to see this, but of the 55 in this cohort trial, we had 24 who had at least two of those three cardinal symptoms.  Three declined the milk protein free trial, 21 accepted, and of those, 14 improved off milk and also had the recurrences of their symptoms at least two hours after re-exposure.  We had on the left one patient who clearly was already on a milk free diet for the same problem.  And then interestingly, we had two patients who had later onset of at least two of these symptoms as we followed them through this study and they too met the criteria.  So we had 17 out of 55.

Next slide.  This shows that they were no different by age or age at onset of CFS, but interestingly, there were more females in the milk protein intolerance group and they were more likely to have had an abrupt onset of CFS in association with usually an infectious illness.  Next slide shows some of their features in infancy.  They were often more spitty as babies, would tend to become tolerant of milk during their childhood, and then after the infection that triggered the illness, seemed to get a recurrence of their neonatal pattern of symptoms.

The early satiety epigastric pain and reflux were more common in this group because that was our definition.  But we were interested that 56% of them had recurrent aphthous or small little mouth ulcers.  And that was very different than the healthy controls.

Next slide.  The changes in health-related quality of life from entry, when we put them on the milk free diet, to six months for those who were suspected at entry to the study showed that the health-related quality of life was lower if you were milk sensitive than if you were milk tolerant.  So PedsQL score was 47 versus 57 and that was significant.  After removal of milk from the diet, along with the other treatments that both groups got, that difference disappeared and the same was the case for the fatigue score and for the functional disability inventory.  So that the health-related quality of life was affected by milk, we believe, and improved on a milk free diet.

Next slide shows our conclusion.  So among adolescents and young adults with CFS, 31% had milk protein intolerance.  And if you do the 95% confidence interval around that estimate, it's between 19% and 43%.  And to put that in context, cow's milk allergy by self-report occurs in about 6% to 7% of children.  It's a bit lower in the entire population because allergies typically get less frequent to food in adolescence and in adult life.  So this 31% was a striking difference from what one might have expected.

Of interest, 59% of those who proved to have milk protein intolerance were really unaware that milk was a problem for them.  They didn't get any immediate feedback from eating milk products that alerted them to the potential that was the cause of their symptoms, like their pain or their reflux four hours later.  As we showed, those who milk protein intolerance had worse health-related quality of life at baseline, but not at six months after we'd taken milk out of the diet.  And although we were treating them with other things simultaneously, the slope of improvement for the group that was milk intolerant started to normalize and be like the other group.

The other thing was that the improvement in health-related quality of life was very similar or consistent with the reports of improvement in their upper G.I. and their systemic symptoms.  And the improvement was usually evident within about two weeks.  So we conclude that milk protein intolerance is a common but treatable problem in those with CFS.  Not everybody with the illness needs to be on a milk free diet by any means, but it's important to search for this possibility even among those who don't think milk is a problem, if they have two of the three cardinal symptoms of epigastric pain, reflux, and early satiety.

The next slide shows a couple of the limitations.  One was that the tertiary care setting of the study creates a potential for referral bias.  We didn't do skin and rash testing to exclude IGE mediated reactions, although we didn't see that very - in any of the patients.  That was part of our definition.  To really clinch this condition's diagnosis, though, you'd need double-blind, placebo-controlled oral food challenges as the gold standard to confirm that this was a response to milk protein and that would also help evaluate the mechanism of the reaction. 

So I'm going to - the next slide just lists the acknowledgments.  We've had grants over the years from a variety of groups been.  We've been very fortunate to have the support of the Sunshine Natural Well-Being Foundation who endowed a chair in chronic fatigue syndrome.  My research coordinator, Colleen Martin, has done a tremendous job getting the data together for us.  We've been very fortunate with the quality of the summer students who are listed here.  (Maria Roma) has returned this summer after working with me last summer but the others have done a great job.  And interestingly, most of them have gone on to health careers.  John is finishing his anesthesiology training here.  (Allie Johns) is a PA.  (Marissa Flaherty) just finished her psychiatry residency.  (Jocelyn) is in an MD/PhD program.  (Samantha) is a working occupational therapist.  (Erika) finished medical school or finishes medical school this year and (Megan) is a PT.  So we've been very fortunate to have such qualified people.

And none of the work that we do at Hopkins would be possible without the generosity of a number of families and some of the people who have been most important are listed here, including (Bill) and (Vickie Boyce), especially, who have been supporting our efforts over the last two decades.  So let me end there and see if people have questions (Faith).

(Faith Newton):Thank you, Peter.  Questions for Dr. Rowe? 

(Amrit Shahzad):Hi, Dr. Rowe.  This is (Amrit).  Quick question.  In your studies, did you take into consideration any concomitant treatment these patients were taking?

Peter Rowe:       Yes, we compared - we had a table in the study where we look at the number of patients who were on a variety of different medications and how many got physical therapy, for example.  And most of these things were similar.  So it wasn't - we were randomizing as in a trial where they got a milk free diet and nothing else.  This was very much a practical study.  So we have - that is a caution in the interpretation of the data.

(Faith Newton):Other questions for Dr. Rowe?

(Courtney Miller):I have a specific one.  This is (Courtney Miller).  On the milk protein study, is there a correlation with the orthostatic intolerance symptoms, or in terms of your definition of there's a high overlap in pediatric patients ME/CFS and (HOTS)?

Peter Rowe:Yes, so think about it this way that of that group of 55, almost all of them have orthostatic intolerance.  It's very unusual to see a pediatric ME/CFS patient who does not report increased symptoms when they are standing for any period of time longer than five minutes.  And what we had noted clinically is that some of the patients would get much dizzier when they had been exposed to milk, if they were allergic, if they were having this hyper sensitivity response. 

Others would report that if they cheated on the milk free diet, they would get more brain fog or migraines.  Others would get sinus congestion.  So the milk exposure, and we know this from the eosinophilic esophagitis patients, can  lead to rather systemic problems that can include not just the G.I. problems, but autonomic difficulties, headaches, and cognitive dysfunction.

(Courtney Miller):And do you observe that those symptoms improve on a milk free?  I think that's the inverse of what you just said, but those improve.

Peter Rowe:       They usually become easier to manage and my pitch to the adolescents if they like milk and don't want to give it up is that we really need to identify it's a problem for you.  Because if you're consuming milk and you're sensitive to it, nothing else that we do is likely to have much of an effect.  That's just our clinical observation over the last 20 years. That if they're continuing to consume milk, it will overwhelm the effect of anything you're doing for their orthostatic intolerance.  They'll just stay sick.

Now, taking milk away doesn't make everything better, but it makes it just easier to manage and a bit less chaotic.  And I think that this is important to recognize, especially in formal trials, because let's say you’ve got somebody who goes into a new trial of a medication.  They don't know they're milk allergic and they decide gosh, I'm going to try and eat a healthy diet.  I’m going to have yogurt every day.  And then they don't know why they're so much sicker.  So they haven't linked the association between the food intake and the increase in symptoms.  And that increase in symptoms could eventually, at the right time, get blamed on the study medication. 

So I think it's really important to screen for this before we put people in treatment trials.

(Donna Pearson):This is (Donna).  You may have answered this question but is this specific to cow's milk?

Peter Rowe:The patients who are reacting to cow's milk, because of the antigenic similarity, usually are also reactive to goat's milk or whatever other kind of milk you can identify.  A small proportion of them are also reacting to soymilk and one of the slides that I used in my talks is about a girl who came to see me.  She had already had her (TILT) test.  She had orthostatic intolerance but she had terrible GI, upper GI symptoms, and was - and I thought was going to turn out to be reactive to milk. 

So I took her off the milk protein and asked her to come back in three weeks.  And when she came back she was really giving me the stink eye because she felt worse.  And we thought, well, if you remove milk from the diet, it shouldn't make you any worse.  It's not an essential ingredient in our diet and it had to be that she was more reactive to something else she replaced it with, which turned out to be the case.  She was allergic to both soy and milk protein.  And when we took her off both, she had the expected improvement.

If you fast-forward about 20 years, she's now had two children, both of whom needed - had such a bad colic and bloody diarrhea in infancy on milk containing formulas that they had to be treated with amino acid formula.  So we had this sort of long-term follow-up that helped confirm what was going on with her. 


(Donna Pearson):We're talking animal milk only and not, like, a rice milk or an almond milk?

Peter Rowe:Right, sorry.  For most people who are milk allergic, they can try - they can take almond milk or rice milk, or soy.  Only a few will react to the soymilk. 

(Amrit Shahzad):So if understand correctly from your slides (unintelligible).

(Faith Newton):(Amrit), identify your please. 

(Amrit Shahzad):I’m sorry?

(Faith Newton):Say your name.

(Amrit Shahzad):Sorry, (Amrit) here.  Quick question on the (unintelligible).  If I understand that correctly, you’ve done that twice a year and the study has been over two years.  So would you say that the data you have collected in the (unintelligible) would be adequate representation of what happens with these patients through (unintelligible)?

Peter Rowe:Well, at least in our hands.  I don't know that we - we may be more aggressive about certain things than other practitioners.  For example, you know, and if you look at some of the suggestions on treatment of ME/CFS from the pediatricians, some of prominent people who publish on pediatric ME/CFS in England, they don't even mention orthostatic intolerance.  So they're clearly not treating for it and they use much more cognitive behavioral therapy than we do.

But at least for our group, we see very nice improvements in the overall quality of life over the two years.  Not in everybody though, and that’s I think the challenge for all of us is that these patients have very complex disease and we don't have enough scientific understanding to help them all at this point.

(Amrit Shahzad):This is (Amrit) again.  Following up on that, do you see any evidence of that milk allergy reflected in the biochemistry and the antibody profile that you're looking at or is it just a symptomatic thing?

Peter Rowe:It's at least in the way we did the study, we were just focusing on symptoms. I think it would be fascinating to be - to have the collaborators scientifically to look at what changes following four hours after a milk protein challenge in the ones who've gotten better on a milk free diet.  I think there's a lot of potential, for somebody who is a lab-based investigator, which I am not, to identify changes in - you could look at the proteins in the blood.  You could look at gene changes that might correlate with symptoms, very much like people have done with exercise challenge or other forms of challenge.

But I think that's a very important area that needs to be studied.

(Faith Newton):We have about five minutes left for questions. 

Man:(Unintelligible) with ME Action.  Doctor, I just had a question about the criteria used for these pediatric cases.  I think you mentioned Fukuda and I just was curious why that was chosen instead of the more restrictive definition.

Peter Rowe:We've used that in our studies, mainly because it would allow comparison with other papers.  And I don't think we have a good pediatric ME definition.  There was one published, I think, based on the Canadian criteria back in 2006 but it's rather cumbersome to apply.  And I don't think any of these are a gold standard.  Nobody can link a specific definition to a clear valid case of the disease and that's the dilemma we face on the Institute of Medicine committee as well.  So I think the best we can do is try to describe the populations carefully.  And using the Fukuda criteria, most of our patients also had post exertion malaise, which is - our study was done before the (IM) criteria came out.  But as we looked back, the vast majority of them would've met the Institute of Medicine criteria as well.

Man:Thank you.

(Faith Newton):Any last questions?  Well, let me thank Dr. Rowe for his presentation.  He was very difficult to get because he was in such demand with all the work that he does.  He's an excellent resource for our patents for pediatrics ME/CFS (unintelligible).  So Peter, thank you and I appreciate you taking the time to speak before the committee on the recent updates in pediatrics ME/CFS.

Peter Rowe:My pleasure.  Thank you.  Bye.

(Faith Newton):You're welcome.  All right, recommendations.  We're going to go back to (Cindy Bateman)’s group and I think you guys are going to put up the latest. 

(Gustavo Ceinos):Syreeta has stepped away so I'm trying to do this.  Can you guys see it? 

(Faith Newton):That should be interesting. 

(Gustavo Ceinos):Can you see it?

(Faith Newton):Yes, I can see them.  I am impressed (Gustavo).

(Gustavo Ceinos):I don't mess with this equipment in the room.  She's the only one.

(Faith Newton):I know.  I don’t even want to know what she's going to say.  Okay.  Three was approved.  Oh, you just made it larger.  Oh, I can see four.  Don't go too far.  Okay, there you go.  All right, (Cindy), I'm not reading them.  They're yours. 

(Cindy Bateman):All right, can you hear me okay?

(Faith Newton):Yes, we can. 

(Cindy Bateman):All right.  (SISAC) endorses the establishment of a myalgic encephalomyelitis chronic fatigue syndrome project ECHO or equivalent telemonitoring program to be conducted by ME/CFS disease experts and to establish an existing academic center with Project ECHO.

(Faith Newton):This, we definitely need to hear from the ex-officios.  Is this doable and/or possible? 

(Christopher Tracy):This is Dr. (Tracy) from the DOD.  It's certainly a possibility.  Whether it's doable or not, I'll certainly have to have a request for information on that one from mine.  So you won't get a specific (unintelligible).  So in theory, this sounds like a great idea.  We do similar stuff.  But we'll have to see. 

(Faith Newton):(Vicky)? 

(Vicky   Whittemore):     Sorry, I was muted.  NIH really don't play a role here I don't think so I'm not going to comment. 

(Donna Pearson):This is (Donna).  I just wanted to say that we talk about the fact that technically, we are supposed to be making recommendations for the Secretary and this isn't technically a recommendation.  We wanted to make sure that it was still appropriate that - we wanted to go on the record, I guess, was the point of this.  Is there any objection to that? 

(Faith Newton):Okay, I'm confused. 

(Gustavo Ceinos):I am confused too.

(Faith Newton):If it's not a recommendation, it shouldn’t be up there.

(Cindy Bateman):This is (Cindy Bateman).  So I agree with (Donna).  In number 4, instead of a formal recommendation, we wanted to make a statement that (SISAC) agrees and endorses that establishment of an ME/CFS Project ECHO is something that should be done or equivalent.  Really, it is a statement of our position and how strongly we feel.  And we're not really saying that it has to be done, implemented by a federal agency, but that's what number 5 is about is what would the role of federal agencies be. 

(Donna Pearson):So part of the question was four and five maybe go together.  We're endorsing it and what we're asking from the agencies are these things that are bulleted. 

(Cindy Bateman):(Unintelligible) put them together.

(Faith Newton):Let's go down and read 5 first and see what the situation is.  Because our job is to make recommendations to HHS but, all right, let's read 5 and then come back.

(Christopher Tracy):I agree.  This is (Chris Tracy) again.  I need to know more, like I appreciate the presentation on Project ECHO but I would like to actually go through, maybe have access to the Hep-C area and look and see how it works and how it would work in - you're comparing a disease that there is a known biomarker, there is a known diagnosis, there is a known treatment algorithm that's not controversial.

And to say that we're going to implement something that is a standard approach, to me, there's always - there's even controversy whether there's even a standard approach to this disease or not, whether it should be individualized to each patient or whether it should be - so I find that that - these 3 and 4 is a big statement to kind of make.  Maybe more of a conceptualization that we move forward in a Project ECHO type of formatting or something like that.  But not to actually maybe implement anything at this point.

(Cindy Bateman):            So this is (Cindy Bateman).  Let me finish reading 5 and then I think there will be more clarification because we're really not asking federal agencies to do the medical education.   Let me read 5.  (SISAC) recommends that the relevant HHS agencies, including but not limited to CDC, HRSA, HRQ, and the VA and DOD, actively support the implementation of an ME/CFS Project ECHO.  And once established, by meeting with (SISAC) or the medical education workgroup to identify potential grant contract or other funding mechanisms that could be used to support the development continuation and expansion of the ME/CFS Echo program. 

So number one is we're asking the federal agencies to come to (SISAC) or the medical education workgroup with ideas about how we might pursue funding to support this long-term program that would be based at an academic center.  Then the second bullet is identifying and implementing mechanisms to actively promote the ME/CFS ECHO project to the federal greater medical community and to encourage participation.  These mechanisms could include sending notice to medical professional societies.

Honestly, we could take out the last part if we want to keep it simple, but - because we came up with some examples in the bullet.  I'll finish it - requesting that state departments of health disseminate information to the medical providers encouraging staff at HRSA funded health centers to participate in posting links to the program on each agency's website.

So bullet two is to help us figure out how to promote it.  How do you send out the word - what can we do in a marketing sense to let people know that an ECHO program exists.  And I would offer to say that if the ECHO programs will be continuing medical education through an academic center, so they will meet the standards that's required for continuing medical education. 

(Faith Newton):But the first thing that has to happen is that the ex-officios for the agencies have to, one, know what it is and they have to find out if it's something they can support with their different - in their different agencies.  And they don't have - I don't believe they have enough information to even make - begin to make that decision today.  Am I correct? 

(Cindy Bateman):Well, I would say that there's a lot of information in the presentation.  The core issues about it are all in the presentation and you can also go to the Project ECHO website and there's a vast amount of information about implementing these programs.  This is a very large existing mechanism for improving the equity of healthcare delivery and educating physicians who are not in an academic center. 

(Faith Newton):Comments from the ex-officios?

(Courtney Miller):Well, this is (Courtney Miller).  I'm not one of the ex-officios but it feels like we need to make a recommendation and have the agencies respond to the extent that they will be involved in it.  Because I think HHS, and HRSA, and more than maybe including CDC, but more than NIH or - could have particular roles in it.  It doesn't have to be a one agency thing.  But I'm very impressed with the amount of work that went into presenting this, the opportunity, the cost effectiveness, the efficiency of this kind of project.  And the reach in terms of equalizing access to medical care.  I think it fits in various mandates of the different agencies. 

(Faith Newton):I understand what you're saying but I'm hearing about this - there's just - I would like to hear from the other agencies as well as the other people sitting around the table.  There has been an incredible amount of work going into it.  We're just hearing about it for the first time, the ex-officios, for the first time today.  I don't know how you can make a recommendation on something that you’ve heard for 45 minutes that comes with a cost that you haven't gone back to your agency or wherever and looked at the information. 

So (Gustavo) or (Beth) can you give some input in here?

(Gustavo Ceinos):I really can't speak as the (DFO).  I'm not supposed to influence your recommendation. 

(Faith Newton):That's true too.  You're not. 

(Christopher Tracy):I think I agree with (unintelligible) - this is (Chris Tracy) again from the DOD.  I would feel more comfortable agreeing to a recommendation that, from the DOD side of the house, that we look at this and provide our support or not support at some point.  And I don't even know if I'm one of the agencies that's really this is going to end up pertaining that much to, just because of the civilian military divide when it comes to our healthcare programing apparatus. 

But I think conceptually this is a great idea and we do stuff like this right now.  It's just, gosh, I've never heard of ECHO until today and so to make this vast recommendation from the DOD that hey, we're going to support this and we're going to implement it.  I'd rather just say, hey, we want to put the DOD on the line to make some recommendations as far as their involvement with this. 

(Faith Newton):(Unintelligible).

(Gustavo Ceinos):I do have a question about the once established.  It sounds like, (Cindy), and correct me if I'm wrong, that you are seeking HHS to support this project once established.  I think that's the message you're trying to convey, and first, you all have to figure out how do you want to establish this?  And then you will have federal support.

(Cindy Bateman):Correct.

(Faith Newton):That's where I'm completely - so you're going to establish it through your 501(c) and then you want federal support after that?

(Cindy Bateman):This is (Cindy Bateman).  As a working group, we're not recommending necessarily where Project ECHO be started and I'm just providing information about one possibility that might be - but we will be independently functioning at our nonprofit, right.  So the idea was to make things easier for federal agencies because it's really difficult to set up continuing medical education, and it's really difficult to do it to the extent that is needed to solve this problem. 

So our workgroup tried to brainstorm ways to assist in implementing the IOM recommendations for dissemination and came up with this as the most cost-effective, most - the highest quality and the best fit for how to move medical education forward.  So our recommendations are that we'd like (SISAC) would like to recommend - or our working group would like to recommend that (SISAC) recommend that we get help from federal agencies to look for long-term financial support of a program, if the program is successful and if it's worth continuing and expanding.

And second, to bring ideas to (SISAC) and to the education group about how to actively promote it once it's established and just needs promotion to let people know it's available.


(Gustavo Ceinos):It sounds like, (Cindy), you want the government to do the marketing in a way after this is established.

(Cindy Bateman):Yes, not to take the full by for marketing but to join in, in the marketing.

(Gustavo Ceinos):(Unintelligible).  Okay.

(MS):     Cindy, this is (MS) from CDC.  I have a question for clarification.  So part of this from your talk, at least my understanding was not only just general education of physicians, but also potentially coaching the physicians on how to manage the patients clinically.

(Cindy Bateman):            Yes, and it's an ongoing program.  So it could be designed any way you want.  It could be monthly, weekly.  It can be changed.  It can be, and it's usually a very interactive program where experts are on one-side and clinicians are on the other side presenting case.  And they talk back and forth.  And it's a case based learning experience that's ongoing and can help clinicians with their - teaching them by using their difficult clinical cases.

(MS):     Right, so they have patients that they're taking care of that they're getting access to experts like yourself to guide them on how to manage the patients. 

(Cindy Bateman):That's correct. 

(MS):So from what you describe, and this is something that CDC doesn't do, as you know, so I'm trying to understand where our role would be.  This, as you rightly indicated, this might be best suited for an academic center or a center with clinicians with good skill and experience in handling and managing CFS, ME/CFS patients seems to me.

(Cindy Bateman):So that's true but academic centers in general are not going to fund this project.  They provide an existing vehicle to do the tele-mentoring. They set it up.  They do the broadcast.  They facilitate it, but the development of a program and the implementation of it in terms of the content by the experts would have to have funding from outside of that academic institution.  And it's usually done by grants or donations and sometimes it depends.  So the funding mechanisms are to promote the quality of the program and to be able to keep it sustained to keep the people who are donating their time, right, reimbursed and be able to develop a good program.

(Faith Newton):So let me see if I can simplify this a little bit.  What you're basically asking for is everybody so term insurance down at the table and work through this.

(Cindy Bateman):Correct.

(Faith Newton):Right.  So to make it simple, you're going to fund the Project ECHO through an academic center but you really want CDC, VA, and DOD to also sit down at the table with you and so that everybody is involved so we can work ME/CFS jointly.  You're just asking everybody to sit at the table.  Right?  That's how I read it. 

(Cindy Bateman):Yes, we're saying if we can get an academic institution to start a Project ECHO and we can figure out how to get it started and drum up the funds, can we bring federal agencies to the table to talk about how to make it more sustainable. 


(Donna Pearson):This is (Donna).  Can I add something to this?  For those who are not familiar with this, and perhaps we should have been clearer, if you Google current funders for Project ECHO, you'll see that the Department of Defense has supported Project ECHO since 2012.  The Chronic Pain and Headache management, HRSA has funded Project ECHO (unintelligible) autism, epilepsy.  CDC has supported Project ECHO on several fronts.  AHRQ was in fact the first federal organization to initiate the thing for Hepatitis C.  The Centers for Medicaid and Medicare supported the complex care program, and I could go on.  It's all there.  It's happened before.  We obviously have a big learning curve, which we've learned but we haven't maybe conveyed as well as we could have.  Sorry.

(Faith Newton):That's a good piece of information because I had no idea. 

Woman:That would be good to include.

(Amrit Shahzad):So this is (Amrit) here.  If I understand you correctly, are you looking for an academic center to be the test pilot for all these resources to come together so you can develop the program and then roll it out?

Woman:Well, it seems like she has one.  She's got University of Utah; am I correct?

(Cindy Bateman):Yes, this is (Cindy).  So let me clarify.  There's you and there's you.  So I was speaking about my activities when I talked about University of Utah, but when I talk about in general, we're talking about (SISAC) and the education workgroup.  So this recommendation in Number 5 is that - is how the Feds can empower (SISAC) and the medical education workgroup to work on these issues.  What information can they bring to (SISAC) and the medical education workgroup about where these grants, contracts, other funding mechanisms might be federally so that we can develop that?

And the second would be, we would like the federal agencies to say if a Project ECHO is launched at an academic center, it's going to need help with advertising and to let people know it exists.  So we would like the federal agencies to come to the table with (SISAC) and the medical education workgroup to identify and implement mechanisms to promote ME/CFS ECHO as a continuing medical education source. 

I would say this is not much different than placing ICFS/ME treatment guidelines on the website.  If there aren't existing guidelines or continuing medical education, then we should be able to find the most high-quality ones available and let people know they exist.

(Christopher Tracy):DOD supports.

(Faith Newton):DOD supports it as written, number 4 and 5?

(Christopher Tracy): I support the conversation (unintelligible) if it will all come out.  It looks to me that's how we're, you know, that's how it's going to be implemented. 

(Cindy Bateman):And (Faith), this is (Cindy Bateman).  I think we should just combine 4 and 5 so that 4 is the first sentence and 5 is the second sentence so that it's clear about the recommendation.

(Faith Newton):And then take out that last sentence that you have?

(Cindy Bateman):That's fine, to simplify, yes. 

(Faith Newton):I was trying to simplify it a little bit more so that it would make things for (Vicky) and (Maya) a little bit easier. 

(Christopher Tracy):This is DOD again and this has nothing to do with this conversation, but this is how we always do it, we make final recommendations the day of the meeting?

(Faith Newton):Yes.

(Christopher Tracy):Because there's such a learning curve on all these kind of things.  There's no possible way to have a document and then for us to synthesize that and come with our questions and actually have a meeting about it as a group in a week or a month.


(Faith Newton):This is what we can do.  We can do it one of two ways.  As long as (unintelligible) is here tomorrow, we can do it - we can wait and think about it tonight and we word it and deal with it tomorrow, this particular recommendation, and move onto her other one.  Although, is this it?  This is your last one?  Is there one - another page, (Cindy)?

I think that's the last one.

(Faith Newton):Okay.  We can work on the wording of it tonight and then come back tomorrow and deal with it.  We have found in previous (SISAC) meetings that when we do that - when we wait, it becomes a disaster.  I was trying to figure out the wording and I actually think that in this case, it's probably a little bit easier if I do it tonight to make it a little bit easier for the CDC and for VA, et cetera, to live - so that they're planning it together at the table, not that they're necessarily endorsing everything.  That we're coming together as a team to figure out how to make this work.  But I can't think of the language right now at this exact moment.

(Cindy Bateman):May I comment again?  This is (Cindy Bateman).

(Faith Newton):Okay, (Cindy).

(Cindy Bateman):Now, I lost my train of thought.   Never mind.

(Faith Newton):Or (Maya) if you could think of some language.  I was going to try and work on the - I think that's actually a good idea.  Let's work on the language tonight and then see if we can make it a little bit easier.  Unless (Maya) if you’ve got something up that you can think of off the top of your head.

(Gustavo Ceinos):No.  I was actually going to suggest this probably needs some vetting within the committee itself, the education subcommittee, to try to clarify the roles of different groups and try to articulate how it could be implemented in a concrete way.  The idea is good.  It looks great. Through who could do it, what are the roles of different groups in agencies?  That’s not clear to me.  I don't know if you could do it overnight.

(Cindy Bateman):This is (Cindy Bateman).  I agree with that and the thing I forgot that I remembered is that my understanding is the role of the working group is to the work for the committee.  And we had two ex-officios on our committee.  We actually had three until (Ted) left.  And so we did the work and were bringing the recommendation to the committee so the committee doesn’t have to do all the work.

Now, we need everybody to be - feel comfortable that they have enough information.  But we did do a great deal of research, and face time, and we did a lot to prepare to make these recommendations.  And we hate the larger committee to be able to have to start completely over.  But we can do that and if we don't make the recommendation at this time, we can clarify our recommendations.


Man:I want to clarify that we should not be asking the ex-officios for endorsement.  We should be asking them whether or not this is implementable and doable at their agencies.  And that is why we came up with the idea of having ex-officios in each workgroup.  So when we come to this point in the game, we are not going to run in circles trying to figure out how to address it. 

(Donna Pearson):This is (Donna).  I think we had (Robin) from the CDC on the call.  She's not in this meeting but I think she maybe knew a lot more about it and seemed to be in favor.  We had (Ted) on the call who now I understand is no longer with the agency but he was in favor.  Regarding the 45 minutes to discuss thing, I just want to point out that's what's supposed to happen and has happened, but for our newest members, (Gustavo) and his staff send out the information a week in advance is the plan and we're supposed to review it a week in advance. 

And we've looked at the recommendations that the working group is going to bring.  And then if we don't understand it to our own satisfaction, we have the right to contact the working group chair or ask a (unintelligible) to put us, whatever it is, so that we get the information that we need before we get to the meeting so that we can comfortably make a decision.  Obviously, we can't get all the information, but I think some of us assumed that all of the ex-officios were familiar with Project ECHO and clearly that is not the situation.  I had never heard of it either before.  I'm thrilled about the whole concept.  But that's how it's supposed to work.  We can't have meetings outside of open meetings as a whole group so you can only be asking questions individually between the meetings.

(Courtney Miller):That's correct. 

(Amrit Shahzad):This is (Amrit) here.  If I may, quickly, I think I'm (unintelligible) that, you know, even when the slide deck is sent out and we have all the information, the discussion brings out points, which I think we need to absorb the information and we do need to check in with other people with other expertise within the agency and come back and tell you.  It may be that the answer is that they can do it better or they can do it differently.  But there should be time between the presentation and between the times when the agency can say, you can limit that there is a finite amount of time, but you have to give them time to absorb the information and come back to you with recommendations. 

(Donna Pearson):We have six months between meetings.  So we try to put the recommendation out there as best we can.  We then get a response from the agencies anyway, formally, and then we can come back at the next meeting if it needs to be revised.  It's just if we don't do it that way, if we postpone it another six months, then we could end up being in that same position and the now, a year has gone by.

 (Amrit Shahzad):I completely am with you (unintelligible) and I don't say it has to wait for the next meeting.  But give them a week and they can come back to the chair or the person who is asking for the recommendation and give their feedback to them.  So they've had the time to absorb what you're giving them, go back to their agency, come back, and give the information to you directly.  All of us don't have to be online to understand what's going on, but you present the information to all of us, they take it back to the agency and they come back directly to you and say, hey, this is what we can support.  That way their needs are met and your needs are met.

(Donna Pearson):But we have to make a recommendation - we have to vote as a group to submit a recommendation at the meeting, at the open meeting, at the public participation (unintelligible) too.  We can't make a recommendation a week later, just to clarify, if that's what you were saying. 

(Courtney Miller):This is (Courtney Miller).  We make recommendations to the Secretary.  What happens at the next meeting is the agencies respond.  So the recommendations here are to set up meetings to meet with the medical education working group to identify potential grants funding mechanisms, contracts, implementation mechanisms, and to encourage precipitation.  So the recommendation isn't that they have to just go do it.  The recommendation is that we put together a table with the agencies that are relevant to implement it in the best possible way, and to seek support from the agencies.

So I don't think one has to (unintelligible) six months.

(Faith Newton):What (Courtney) is saying I would say could be used to support the development?  I would take the word continuation and expansion out and just leave it like that, to support the development of the ME/CFS ECHO program.  And then I would like to put another word in there, to development of the ME/CFS ECHO program.  Because other groups are above it.  I don't even know if I would put the second bullet in there because it's covered by everything in the first bullet.

(Cindy Bateman):We may need to simplify it but the first bullet was about helping to identify sources of federal funding to brainstorm and talk about it for the committee.  The second was to help with promotion of the product.

(Faith Newton):Right, they have to decide first whether or not they can do it.

(Gustavo Ceinos):(Cindy), are you referring to the first bullet, for example, the meeting that I'm trying to set up with HRSA about funding mechanism for ECHO within HRSA?

(Cindy Bateman):Yes.  Where are you, you're number 5, right?

(Gustavo Ceinos):Yes, first bullet under 5. 

(Cindy Bateman):So our recommendation to (SISAC) - from (SISAC) - we're suggesting that the recommendation to the Secretary from (SISAC) is that if a program is developed and established that the federal agencies would be willing to come work with (SISAC) and medical education to identify funding mechanisms, and also to brainstorm and talk about how do you let people know this program exists and disseminate it.

(Faith Newton):Actually, could they support the program.  That's the first question.  Can they support Project ECHO and if they can, how are they going to support it. 

(Cindy Bateman):Well, I think it's harder - it's a more difficult question to have them say they will support it.  I think…

(Gustavo Ceinos):Go ahead.

(Cindy Bateman):We tried to make it more doable.  It may not be clear but we tried to make it something was actually doable now without having to - any federal agencies to take on designing the program, implementing the program, deciding if it's evidence based, all that.  But just to be able to help us access existing resources, to seek funding and to help disseminate the information that it exists so people will sign up for it.

(Faith Newton):I understand that but they still have to decide if they can support it or not.  That still have to be the first decision.

(Gustavo Ceinos):I understand that now and I'm not sure - I think to some extent everybody is - let me tell you how I see it.  I see at this.  The committee is recommending to the Department that the Department, meaning all the agencies within HHS and those that are working with us, meet with the medical education workgroup and help them identify funding sources within the Department.  It does not say to fund it. 


(Gustavo Ceinos):And then if that happens, let's assume that wow, HRSA all of a sudden finds money and wants to fund it.  Then to help the committee implement it and promote it.  That's what the second bullet is saying.  Right, (Cindy)?

(Cindy Bateman):Yes, we're saying if an ECHO program exists, we would like ideas from the federal agencies about how to let federal positions and the greater medical community, how we help spread the word that a highly accredited medical education program exists, so they can access it.

(Gustavo Ceinos):But what might be throwing people off is the actively supporting implementation.  It sounds like you're asking the Department to fund it.

(Cindy Bateman):Where are we?  Which one?

(Faith Newton):Yes, that's what I thought too. 

(Cindy Bateman):Which bullet?

(Gustavo Ceinos):Number five.

(Cindy Bateman):It says, well, then take that word implementation out.  Because what we want is for them to support an existing Project ECHO once it's established in these ways. 

(Faith Newton):Okay.  That's what you want?  Okay. 

(Gustavo Ceinos):Okay, let (Cindy) and I work on this because I'm typing.  Actively support - go ahead, (Cindy).

(Cindy Bateman):An ME/CFS Project ECHO once established, yes, by then you can take the rest out.  Okay.  What else? 

(Donna Pearson):Perhaps we could put once established in parentheses. 


(Cindy Bateman):I like what (Gustavo) (unintelligible) and (unintelligible) are doing.  Let's put the meeting with (SISAC) or the medical education workgroup up in that sentence. 

(Faith Newton):Can we just change it to the meeting with the medical education workgroup?  Because (SISAC) is meeting twice a year.

(Cindy Bateman):Well, let's just leave it there because it's or. 

(Gustavo Ceinos):No, we can do meeting with the educational workgroup.  That's something that I can do.

(Faith Newton):Okay, all right.  Fine with me. 

(Gustavo Ceinos):I'm trying to do that now, having HRSA meet as a workgroup to discuss exactly what bullet number one is saying.

(Faith Newton):No, I said to take out meeting with (SISAC). 

(Donna Pearson):It should probably say meeting with the (SISAC) medical education workgroup because that's what we are. 

(Gustavo Ceinos):Exactly. 

(Faith Newton):Works for me.

(Cindy Bateman):So I think it would make it more clear if you put that partial sentence up in the top and let the bullets say to identify potential grants and to identify mechanisms to actively promote.  So just put meeting with the medical education workgroup to and then colon, yes, that's fine, and then make that a bullet. 

(Gustavo Ceinos):I can do that later.  Our system doesn't allow us to do that now. 

(Cindy Bateman):Okay, to identify potential grant mechanisms or funding mechanisms and then to identify and implement mechanisms to actively promote the project. 

(Gustavo Ceinos):Oh, you want to do it like that?  Okay.  Go back to the - okay. 

(Gustavo Ceinos):That's (unintelligible) not me.  I told you she's the one who knows this. 

(Cindy Bateman):And then bullet two would be to identify and implement mechanisms. 

(Gustavo Ceinos):We can leave it as is and you guys can sleep on it and discuss it tomorrow if you feel comfortable.  I can send this out to everyone. 

(Cindy Bateman):Sounds good.

(Gustavo Ceinos):Or you can finish business now.  Up to you.

(Cindy Bateman):I say that we leave it like it is and just take out the latter part of that.  Just (unintelligible) identify and implement mechanisms to actively promote the project and then take out the last sentence. 

(Gustavo Ceinos):All of this?

(Cindy Bateman):Yes.  And then if you want to be - if you - take the I-N-Gs off of identify and implement. 

(Faith Newton):(Cindy), while he's typing, I want to commend the amount of work your group did.  It's amazing.  I mean the presentation was excellent.  It was detailed, well thought out.  You did an incredible amount of work and I wanted to commend all of the members of your working group because it was very, very well done.

(Cindy Bateman):Yes, it's pretty packed so I think if everybody has a chance to review over it, then it will start to make more sense.  I think a lot of the information is there.  It was just very dense. 

(Faith Newton):There was a ton of information.

(Gustavo Ceinos):And what I liked about this that now (unintelligible) compared to two years ago when I took this position, these five recommendations are doable.  In other words, the committee is not putting out recommendations that are really not doable, at least until now. 

(Cindy Bateman):Right, that's what we're trying to do, put out recommendations that are doable.  (Faith Newton):I think there was one more recommendation. 

(Faith Newton):We've got 15 minutes.

(Cindy Bateman):That was the recommendation about, let's see.

(Gustavo Ceinos):No, I mean this is…

(Cindy Bateman):It wasn't a recommendation.  It was just something to think about actually when we talked about the ECHO Act and we wanted to ask the committee, or ask you, (Gustavo), if it would be possible to have someone come to (SISAC) and report on the ECHO Act, which was really an act to ask the Secretary of Health to study and write a report on Project ECHO.  And I'm sure it's ongoing and maybe close to finished.  And that would help give the committee context about (ECHO).

(Faith Newton):Well, if you guys get as far as you're going to with this, in December at the live meeting that would be a really good presentation to have. 

(Gustavo Ceinos):I'm looking at the PowerPoint.  Bear with me one second, (Cindy). 

(Cindy Bateman):Look at Slide 22 and 23. 

(Donna Pearson):This is (Donna).  While we're waiting, I just want to make sure that everyone is clear is that what (Cindy) is saying is that disease experts at an academic center are actually going to establish the Project ECHO outside of the government.  Is that clear so the Secretary will understand that?

(Gustavo Ceinos):We tried to bring up, because I didn't see it as a recommendation, (Cindy).  Yes, medical (unintelligible). 

(Cindy Bateman):Yes, it was - I made a mistake.  It wasn't a recommendation.  I was just hoping that as part of our discussion, we could - I could make the committee aware of the ECHO Act and that it was signed at the end of 2016 and this Act asked the Secretary of Health and Human Services to study the impact of Project ECHO and to write a report. 

(Gustavo Ceinos):My only concern on this is that this was signed under a previous administration.  This is a new administration so I'm not sure how it will be viewed by the current Secretary. 

(Cindy Bateman):Can we inquire?

(Gustavo Ceinos):We can find out.  I can look into it and get back to the workgroup.  And then probably have more information at the December meeting.  But let me what the Secretary (unintelligible) for medical education (unintelligible).  I could find out.  We'll see.  I'm not sure if this something that even has been implemented with this administration given the fact that it's a new administration and this was done by the previous one. 

(Cindy Bateman):It will be interesting to know. 

(Courtney Miller):This is (Courtney).  We can invite someone to present on ECHO programs in December? 

(Faith Newton):The working groups always have the opportunity to invite somebody to present.  You go through the Chair and the (BFO) but yes, you can invite folks and that was one of the things that (Gustavo) said at the very beginning.  We were trying to see if we could get the ICB Code 10 but there was a conflict.  So she presented at one of the working groups. 


(Faith Newton):We've got so much going on with the working groups and I have to commend everybody because there's only right now five (SISAC) members and all the ex-officios, and the amount of work that's gotten done between now and January has been absolutely astronomical. 

(Gustavo Ceinos):So given the fact that this is not a recommendation, yes, I can speak on it.  We'll find out with my leadership and the Office of the Secretary what the status of this is.  I can give you a head's up given the fact that this is a new administration.  Don't be surprised if this hasn't been addressed by HHS.  So we'll - but I will follow-up with (Cindy) and update the working group, and hopefully have more information by the December meeting. 

(Cindy Bateman):That works. 

(Gustavo Ceinos)So can you, Syreeta can you put the recommendation back up?  You guys want to sleep on this, discuss tomorrow, or vote on it as is? 

(Faith Newton):I would like to sleep on it.  But I'm not sure what everybody else wants to do. 

(Gustavo Ceinos):Why don't you take a roll call, sleep on it or vote on it and then act accordingly.  (Faith) wants to sleep on it.  (Donna), now or tomorrow?

(Donna Pearson):I'm prepared to vote now but we want to make sure we have the vote (unintelligible).  We haven't even started voting (unintelligible). 

(Gustavo Ceinos):(Cindy), now or tomorrow?

(Cindy Bateman):I would vote now but I would be happy to wait until tomorrow if people are willing to do a little (unintelligible).

(Gustavo Ceinos):I'm taking a little roll call as to what we will do.  (Amrit)?

(Amrit Shahzad):I'd like to sleep on it.

(Gustavo Ceinos):And you guys are tied two and two because (unintelligible) is not on. 

(Faith Newton):Well, (Goodwin) is on our committee. 

(Gustavo Ceinos):But she probably wants to do it now.

(Faith Newton):Yes.

(Gustavo Ceinos):So number four.

(Donna Pearson):(Cindy), you don't object to waiting, right, so that they can…

(Cindy Bateman):I don't object to waiting.  Let's - okay.


(Gustavo Ceinos):Can you please put your phone on speaker.  I can hear (unintelligible) in the back or mute, I'm sorry. 

(Faith Newton):Can you guys put your phones on mute please? 

(Gustavo Ceinos):Thank you.

Ben HsuBorger:(Gustavo), this is Ben HsuBorger with ME Action.  I wondered if I could make one comment on Recommendation 5, whether we want to - right now, it says to actively support once established by meeting with the group and I wonder if that's too restrictive, if we actually want to meet with the medical education working group now, whether it's established or not.  Wouldn’t it be broader to - better to phrase the recommendation in a broader way that we want to meet as soon as possible on this?  That's just a suggestion.

(Faith Newton):Ben, that's a good point. 

Ben HsuBorger:So maybe remove the words once established

(Gustavo Ceinos):It sounds - it's putting the horse before the cart, right, is that how they say in English?

Ben HsuBorger:Yes.

(Gustavo Ceinos):Yes, because it's assuming it's already been established but that's what the recommendation is trying to do.  Well, what we could say is actively support the implementation of - the establishment of an ME/CFS Project ECHO.

(Faith Newton):That sounds good.  That sounds really good. 

(Donna Pearson):That's what we originally had.

(Faith Newton):Oh, you put the word implementation back in there. 

(Gustavo Ceinos):I think it was another place.

(Faith Newton):It was in there and we took it out.  All right. 

(Gustavo Ceinos):So we could say.

(Donna Pearson):Establishment you said, (Gustavo).

(Gustavo Ceinos):Yes, that's what I was saying.  Thank you, (Donna).

(Faith Newton):It should be an, A-N, I think that's the correct English.  There we go.

(Gustavo Ceinos):So I can send this after we finish so you all have to have it overnight and discuss tomorrow, if (Cindy) is okay with it, and (Donna).

(Faith Newton):That sounds good.

(Cindy Bateman):Yes, good by me.

(Donna Pearson):Me too.

(Faith Newton):It's 5:04, not 5:04, 5 of 5:00 and I'm going to actually another meeting that I'm running tonight.  Do we have the phone number up for tomorrow, the call-in number, can we put it up?  Because I think it's different, correct? 

(Gustavo Ceinos):It's a different number, yes, and…

(Faith Newton):So I want to make sure that all of the advocacy groups that it is a different (unintelligible) number.  It is a different participant pass code because we had trouble at one of these (SISAC) meetings last year, one of the webinars, they did not know.  And while (Gustavo) and Syreeta are putting that up, I want to thank everybody for their time today and the work that they did.  I want to thank the ex-officios for their comments and especially the liaison organizations.  I think that this morning, a comment may have been construed that I did not think you were working together.  I have been impressed with the amount of time that you are working together and all of your efforts, whether it's through ME Action, the May 12 day, the showings of unrest, all of the work that you are doing.  It's been incredible. 

(Leah Williams):This is (Leah Williams).  That's the participant code, not the code for members of the committee.

(Gustavo Ceinos):This is for the public.  The participant code I sent to everyone and you guys should have it. 

Man:And everybody for those who are listening on the phone, or viewing on this, the code for tomorrow is on the agenda at (SISAC)’s website.  And we linked to that in our announcement of it too that (unintelligible) find the passcode and the number.

(Faith Newton):That would be wonderful.  Thank you again to all of the patients that spoke out today.  That was really, really nice for you to do that (unintelligible) it took a lot of effort.

Any other comments from anybody, (Gustavo)?

(Gustavo Ceinos):No, just a reminder for the public that this is a new number.  Tomorrow, it's a different number but if for any reason, please always go to the website.  The URL to view the presentations and the code for the - to listen to the discussion, it's on the website.

(Faith Newton):Everyone have a nice meeting.

(Gustavo Ceinos):You have to call the meeting or adjourn.

(Faith Newton):That's right, I'm sorry.  Is there a motion to dismiss the meeting?  (Donna), somebody say yes.

(Donna Pearson):(Donna Pearson), so moved. 

(Faith Newton):Is there a second?  (Amrit), say yes there's a second place or somebody. 

(Gustavo Ceinos):(Amrit), just say yes.

(Amrit Shahzad):I did say yes.

(Faith Newton):Good.  The meeting is adjourned.  Have a nice meeting everyone. 


Content created by Assistant Secretary for Health (ASH)
Content last reviewed on July 17, 2018