TBDWG February 12, 2018 - Transcript
Note: The transcript of the February 12, 2018, Tick-Borne Disease Working Group meeting is provided below. It has not been reviewed by the commenters to correct any errors. In addition, there were technical difficulties that made some of the discussions challenging.
Jennifer Gillissen: Welcome to the Tick-Borne Disease Working Group Meeting Number Three. My name is Jennifer Gillissen, and I’m with Kauffman and Associates, and I’ll be providing some technical assistance during the virtual meeting. I’d like to start with explaining a little bit about the webinar interface. You should all see the first slide of the PowerPoint presentation and Q&A box to the right. If you need technical assistance during the webinar, please use the Q&A box. Myself or one of our technicians will contact you to resolve the issue. When it is time for the subcommittee breakouts, we will have a box that contains the name and link to access the breakout. Please click on the subcommittee breakout you want to observe. Once the subcommittee breakouts conclude, you will see the same box and click on the link to bring you back to the main webinar. Speakers and working group members, please press star six to mute and un-mute your line. Please note, this webinar is being recorded. I will now turn it over to Mr. John Aucott, Chairman.
John Aucott: Welcome everyone to Meeting Number Three of the Tick-Borne Disease Working Group. I call the meeting to order and will take attendance. When I call your name, answer in affirmative if you’re present. Wendy Adams.
Wendy Adams: Present.
John Aucott: Ben Beard.
Ben Beard: Present.
John Aucott: Scott Cooper.
Scott Cooper: Present.
John Aucott: Dennis Dixon. (Silence.) Dennis Dixon. Kristen Honey.
Kristen Honey: Present.
John Aucott: Richard Horowitz.
Richard Horowitz: Present.
John Aucott: Estella Jones.
Estella Jones: Present.
John Aucott: Lise Nigrovic. (Silence.) Allen Richards.
Allen Richards: Present.
John Aucott: Vanila Singh. (Silence.) Vanila Singh. (Silence.) Pat Smith.
Pat Smith: Present.
John Aucott: Robert Smith. (Silence.) Karen Vanderhoof-Forschner.
Karen Vanderhoof-Forschner: Present.
John Aucott: Are there any working group members that did not respond? Please respond now.
Multiple Unknown Persons: I think I’m in the wrong meeting. This is... I’m supposed to be in a subcommittee. So, this is the meeting of the whole working group right now. So, you’ll be joining later in the day. But the subcommittee members are on the phone, but they wouldn’t necessarily be on the speaking line. So, we’ve got maybe a little mix-up there, but that’s fine. Okay. Yeah, I’m on a subcommittee, also. What? Am I supposed to be here? No, you aren’t supposed to be here now, but don’t worry about it. You’re seeing a little bit extra. So, you got the value ticket. Just mute your line though, please. Yeah.
John Aucott: So, I’m going to start off with a recap of Meetings One and Two that occurred last month, and I just want to overview the accomplishments of those first two meetings. We heard from invited speakers that gave us a diverse set of opinions and really focused on expanding the national consciousness of tick-borne diseases and emphasizing the magnitude of the problem. We heard from those that spoke about maintaining an open, balanced interpretation of the field and the literature. We heard about implementing awareness and prevention campaigns, advancing diagnostics, understanding chronic symptoms, following therapy of tick-borne disease, improving surveillance and vector control – a broad range of opinions. This is complemented by public comment. It’s focused on personal stories, the personal toll of the illnesses related to tick-borne disease, difficulty accessing affordable care, the lack of progress in research to help diagnose and treat their illnesses.
On Day Two of the meeting, we started the discussion of the vision, mission, and values, which we’ll pick up today under the leadership of Kristen Honey. And we got a big accomplishment done by discussing and voting on the formation of the subcommittee. So, we now have six subcommittees, including disease, surveillance, and prevention; pathogenesis, transmission, and treatment; testing and diagnosis; access to care and support to patients; vaccine and therapeutics; and other tick-borne diseases and co-infections. You can see it’s an incredibly diverse group of topics, and it really gives us a challenge to address a broad range of issues in the coming months.
Between those meetings, today, I also wanted to update you. Your team has been hard at work. Our working group members self-nominated themselves for different co-chair positions of the subcommittees, and those co-chairs were selected and everyone received a co-chair from the main working group. Those co-chairs then stood by as we opened the nomination process for subcommittee members. You’ll be amazed to know that there were over 200 applicants for subcommittee members.
The co-chairs of each of their subcommittees worked on evaluating, processing those applications, scoring the applications, and put together a list of recommendations for their subcommittee to the chair, co-chair, and DFOs. And those lists were then looked over for balance, lack of bias, and were approved with minor modifications. And those are the subcommittee members that you see today and that were finalized.
So, that’s the process that has been so far. I’m going to take the prerogative of the Chair to just take a step back and talk a little bit about perspective as we move forward into our next meeting. I want to say, there’s been amazing progress, and I thank the working group members and the subcommittee members for joining in there.
(Background noise and echo sound - 00:06:05.)
And just to remind us all that we’re here for our patients, our families, and for the public that counts on us. And so our last meeting, I’ve seen over 200 patients in my clinic with illnesses related to tick-borne diseases. So, the problem goes on and, you know, by and large, the patients that I see don’t even know about the controversies in Lyme disease and tick-borne infections; they just trust that their institutions and professionals are looking out for them and doing their best for them. And that’s, of course, why we’re here today, is to serve our patients and the public.
And with the essential list—and we’ll hear more about this and constantly remind us—it’s about diverse participants that are essential to the process. It’s about collaboration, is our essential method. We can’t do this with just one group alone. If we work together, this is truly an historic opportunity to move forward, not to dwell on the past, but—as Kristen said last time—to reboot to the future and to really put the old biases and stereotypes behind so that we can focus on knowledge and truth. And that will trump all the controversy. And that’s how we plan on serving our patients and the public. So, it’s really with great honor that we have this group here together.
So, the purpose and goals of today’s meeting is to... We’ll be doing an overview of the report that we’ll eventually make to Congress, and the HHS Secretary, Rich, will go over that. We’ll be reviewing the mission, value statements, and hopefully voting on that led by Kristen. We’ll have a report on some of the staffing issues and the progress. We’ll have some speakers that will... I’m sorry. The last one we’ll have a report from the Internal Health and Human Services Tick-Borne Disease Working Group from invited guests. We’ll also have a second invited guest that will be telling us about the successful experience in the state of Virginia on collaborating on tick-borne diseases. We’re then going to do something different and break out into subcommittees.
So, each of you should have signed in for a subcommittee, and those subcommittee breakout sessions will be led by the co-chairs of each subcommittee. The six subcommittees I talked about will be talking there and, later, about public comment. And then after the individual breakout sessions, the subcommittee co-chairs will report back as we rejoin for a full group. They’ll report back to the full group as we rejoin from the subcommittee call, and then we’ll finish up with the path forward and the future events. So with that, I think we’re going to turn things over to Rich, right?
Rich Wolitski: Kristen, do you want to go?
Kristen Honey: I’ll keep it really short, because we’re behind schedule. But just, thank you, everyone, for your continued work the past month, because we’ve had a lot of behind the scenes. And welcome to all 53 subcommittee members who have joined us. So, we cannot do this alone. It’s a heroic team effort, and thank you all for being a part.
Rich Wolitski: Hear hear to that. I mean, you kind of kept us more busy than any other advisory committee in the history of the Office of the Secretary for Health.
Rich Wolitski: So, it’s definitely been a lively group. I’m going to go ahead and take control of the screen here, and Jennifer, if we could advance this... I guess I can advance the slides now, right? So, I’m going to go ahead and get started and kind of give you the quick update on where we are with... So, we’re going to talk about the report to Congress. I mean, this is the document that this whole group exists to produce so that we can inform Congress and the HHS Secretary about what’s being done currently, what the gaps are, and what the opportunities are that remain to be fulfilled. Does everybody know that this is a legally mandated effort? In the 21st century Cures Act that established the working group, it requires us to submit a report every 2 years to the Committee on Energy and Commerce in the House; and to the Committee of Health, Education, and Labor and Pensions in the Senate; and also to the Secretary of Health and Human Services. Not only do we submit this report to them, it has to be made publicly available on the HHS website. That first report is due December 13.
When we started this, it seemed like it was a little ways off, but now it is right on us. So, there’s some things that we have to address in the report. Now, first of all, we have to cover what’s going on currently in tick-borne disease research. This covers a wide range of issues. We need to address, “What are the advances that have recently been made? What are the federal activities related to tick-borne diseases, including Epi, clinical, translational research? What are the gaps? What has this working group been doing? What are the comments that we received from the public as part of our public comments? And what are specific recommendations to the Secretary and to Congress in this report?”
As part of this process, we’ve been asked to solicit input from states, localities, and non-governmental entities, which we’ve been doing through the public comment, through your emails that have been coming in to the tick-borne disease mailbox. And I have to say, so far, we’ve gotten over 700 emails from folks about this process. It’s been an unprecedented amount of input. So, we’re facing a number of challenges in doing this work. I mean, I think, first and foremost, we have to recognize that this is historic. It’s unprecedented. This report has not been done before.So, we have to make it up as we go.
We had a little bit of a late start. The group was formed 10 months after the Cures Act was enacted. It took a little bit of time after that to get the members appointed and have our first meeting. We met the first time December 11, 2017. We’ve now just gotten the subcommittee members identified and are having our first meeting here today. So, in looking at the timeline—and we’re going to go back to the timeline again and again and again in this meeting—but basically, we have until July to get the report written so that we can have time for public comment and agency review. We’ve been short-staffed during this effort because of the hiring freeze that has been government-wide. We’ve also been overwhelmed by the intense interest that has come from the community in this work and managing the input, the ideas, the feedback that people have and getting them organized. It takes a little bit more work than we had anticipated, and we’re kind of at the point now where we’re going to catch up with that, and we’re getting a system in place, but it’s been overwhelming thus far. And the other issue is that... You know, when we look at what Congress has asked us to cover in this report, it’s a lot of territory, research, and programs in every single aspect of this disease, and it’s a lot of ground to cover. To also note that, you know, there are gaps in the research. There hasn’t been funding to do all the research that needs to be done, and a lot of the evidence that exists isn’t easily identifiable in the peer-reviewed scientific literature. And we also know that a number of these issues are quite controversial with very strong opinions on one side or another and evidence to support those different positions, and that’s taking time to work through, as well. Then, we have a lot of different types of evidence that can be considered and that will be considered as part of this process. We have evidence from systematic reviews of the research literature; research articles that have been published in the peer-reviewed literature; non-peer-reviewed publications and presented at conferences; reports and other documents that come out from the agencies, organizations, and programs—so, it’s governmental and non-governmental—the presentations from subject matter experts across the country, from family members, from people who have been affected by tick-borne diseases, and their health care providers. We also have public comment, and we’re going to be conducting an inventory of programs and activities at HHS and DOD.
So, for the first year report, I’m going to kind of highlight some of the scope that we’ve tentatively been focusing on for the first report. There will be some opportunity as we start the writing of the report to make some adjustments. But for the most part, these are some of the general parameters that we’re working under right now. So first and foremost, you know, I think it’s important to remember, this report is being written by the working group. It’ll be informed by some of the materials that the subgroups work on and identify and submit to the working group. But at the end of the day, it’s the working group’s responsibility to take that information, other information from other sources, and their own knowledge and to craft a report that everyone *** (indistinct due to background noise) ...our office here at HHS, as well as with Communicate Health and Kauffman and Associates.
We’re going to initially focus on HHS and DOD activities, and we’ll be talking about later in this agenda the inventory that has been drafted to try to collect that information to inform the report. Now, there’s a lot of different topic areas that need to be covered, and within each of those topic areas, there are dozens and dozens of things that one could do. So, one of the first challenges for our subcommittees is going to be to identify, “What are the issues and questions that are important to address?” And then, out of that list, prioritize the subset of those that they’re going to be able to review the literature on, look at the evidence, look at the gaps, what’s being done, and do really an assessment of what needs to be done related to this issue that would make things better for people who are affected by tick-borne disease.
We’re going to go through—in the committees—ask people to focus in reviewing the evidence on the United States, but we’re open to looking at evidence that comes from outside the U.S. if it is relevant to potential solutions that may work in the U.S. In the subcommittees, there’s going to be work that needs to be done on identifying the key studies, looking at reports, guidelines, and other documents that members feel are relevant to the issues that they’re going to be addressing in their work. They’ll also be able to invite presentations from outside experts to their subcommittee meetings. They’ll be able to look at existing reviews that are published in the literature. They’ll also be able to support some additional searches, the scientific literature, and other online resources. We’ve de-emphasized this a little bit for the first year report because we know that we just don’t have the time and the staffing to do a comprehensive systematic review of the literature, which would likely take months and involve reviewing hundreds, if not thousands, of records to ensure that we’ve gotten everything that’s been published on issue.
In the second report, that’s where we’re going to build in the systematic review of evidence and really strengthen the work that’s done in this report in the next iteration of it. So, moving on to... This is, sort of, a preliminary outline that we’re asking the subcommittees to use in guiding the development of what they’re going to be producing. It’s a draft outline that the working group members will be able to start using in developing some of the background materials as we await the subcommittee input. So, we’re going to have a table of content, executive summary that encapsulates the whole report in just a few pages, introduction background section—this talks about the problem of tick-borne diseases, who’s affected, the impact that it has on their lives. We’ll talk about what Congress has done in reaction to that by forming this working group and in other ways. We’ll talk about the working group and its establishment and what it’s done, and also kind of highlight some of the goals and the content of the report in this background section. We’ll go to the method section that really focuses on what the working group has been doing and how the report itself has been put together. And this is the section that, really, I think we’ll spend the most of the time of this meeting focusing on is the components that the subcommittees will be focusing their efforts on.
So, within each subcommittee we’ll be asking committees to develop a written document that describes the topic that their subcommittee is focused on that talks about why it’s important. Next, we’ll talk a little bit about their methods, how they approach the topic. Did they do literature searches? How did they identify experts? Who did they identify to come in and give presentations? How did they do their work? And what does the committee see as the primary sets of issues or questions that need to be addressed in the report? So, if diagnostics is part of someone’s charge for their subcommittee group, in the area of diagnostics, what are the issues that you think need to be addressed and need to be examined more deeply? Out of the set of issues that people identify—we’re imagining it’s going to be like 20, 30, 40, maybe even more for some of those subcommittees—and we’re going to ask folks to basically think about, for each of those issues, which of them is going to have the biggest impact, if we’re able to make change on them, and which changes are feasible within...into the next 3 years, 5 years, or so. And have people do a combination of weighing the impact that an issue may have that’s addressed, and its feasibility, and the amount of work that needs to be done to make a change, and to come up with basically the short list of perhaps three to five priority areas that they think the recommendations need to be focusing on. For each of those, we’ll ask that the groups focus on, “What is the evidence regarding the issue? What’s known about the problem? And what’s currently being done?” We’ll ask you to think about opportunities for improving the federal response. Think about threats or challenges to implementation of the changes that you think may benefit people living with tick-borne disease. Think about possible action for the working group to consider. These are actions that may eventually turn into recommendations or may be part of recommendations that are developed by the working group. And for each of these priority areas, when you kind of do this work, we would really want to know the extent to which the subcommittee is in support of what’s been developed or if there’s controversy or disagreement within the subcommittees. We’re asking that, when each product is developed, does the subcommittee vote on the characterization of each privatized issue and the recommendation...recommended actions, or possible actions that have come out of the work of the subcommittee. So, you’ll take a vote, for example, of its, “Improve diagnostics by doing X, Y, and Z.” And we have a record that says, “Seven of the members were in support of this and three were not in support of it and thought something else should be done.” And those three members then would be able to submit a minority opinion, which would also be part of the report from the subcommittee, to the working group. I think it’s important to recognize that, throughout this process, in the subcommittee process, as well as in the working group process, we will be documenting any minority opinions that are not reflective of the majority, so that doesn’t get lost in the record. So, moving right along, and we’re going to be talking about the results and recommendations in the working group document. We’re looking at an overall summary of what the federal government is doing. Identify key gaps and opportunities to improve the federal response. Again, keeping track of minority opinions. And there will be a discussion or concluding section that will reflect on the importance of taking action now, what could be achieved versus what is actually being achieved at the present and serve as barriers to implementation and strategies for overcoming them.
And we’re also talk about some planned improvement in the second report that will come out from the working group. I mean, it has a lot of appendices and a lot of information that is not going to fit neatly into a concise report; so, we’ll have some online appendices that may include a more complete summary of what the working group has been doing, its members, the same thing for the subcommittees, the results of the inventory for the HHS and DOD activities, and a record of the public comment, which will be available in an online appendix. Also, looking at ways to make it more engaging to the general public and to other stakeholders, so, in considering things that we use as sidebars, infographics to show how the working group works, tick-borne diseases by the numbers, something that, like, focuses on the frontline, looking at programs in action in the community. Also, we know, because of the controversies that exist in the field, that it would be good to draw some attention to those and just acknowledge up front, “Hey, people disagree about this; this is controversial,” and maybe doing some sidebars that are really focused on those controversies and how the various sides see the issue.
And finally, we thought it’d be nice to have some way of highlighting some of the insights that we’ve gotten from public comment in other ways. So, those are some components of it.
Timeline, just real briefly, we’re ready, I think, to start some of the writing tomorrow on some of the background pieces. We’re going to be talking today about the inventory for HHS and DOD. We hope to get that out by February 23 and back by March 23. *** (indistinct due to background noise) ...reports will be due to the working group on May 4 in advance of our next full working group meeting, and each of the subcommittees will be getting information about a more detailed timeline that has breakouts of separate products and a deadline for them so that we know. Like on a week-by-week basis, type up what they’re doing, and it won’t be that all of a sudden everything is due at once and it becomes a huge hassle. So, we’re trying to break it into little pieces for people.
Then the working group takes over from there and works on developing a final draft of the document, which goes out for public comment and agency comment. We’ll begin the public comment *** (indistinct due to background noise) ...and figuring out what to do with it as a working group, making changes to the report based on comment, and then resubmitting it for final HHS and DOD reviews and clearance. And then, hopefully, getting it all done, packaged, and beautifully laid out and ready to go out up on the web before December 13, 2018.
So, that’s kind of an abbreviated sense of the timeline. There’s lots of little steps in between each of these, but I’m going to go ahead and stop there, and we will... This is something that we’ll come back to, as the subcommittees meet, and talk about different pieces of it. I’m sure we’ll have some discussion and questions that folks may have later, and they can submit those by email or by the Q&A function if we don’t have time to get to them today. So, I’m going to stop, and I think we’re ready to go onto the next piece, John.
John Aucott: Great. So, Kristen has been doing yeoman’s work on the mission, vision, and values part that we got partway through on the last meeting. And I’m going to turn it over to Kristen at this point to pick that back up.
Kristen Honey: Excellent. And I want to make sure that our invited speakers have their full times, so I’m going to try to condense this part to 10 minutes. And my recommendation with the working group: If we have these three things to vote on—if we do not think we’re close and can come to consensus and agree on a vision, mission, and values—that we may be moved to have a couple people take lead on wordsmithing it. We iterate online, as we’ve been doing in the background the past month since our last public meeting, and then we can present to the next meeting. But I hope and think we’re very close for the vision and values. Mission maybe needs a little more finessing. And I want to also thank the public for submitting their ideas on how to streamline and improve our vision statement and some of the values that came through the tick-borne disease working group email. So, this is truly a team effort. Next slide, please. So, a vision defined is a future ideal. Where are we going? It basically is our future state. I won’t read this to folks because I believe you’ll have it in front of you. But next slide, please. We had three different vision statements come in, and I will read them each now. And what I’d like to do is to take a quick, you know, a pulse of what people like best. The first one is, “A nation free of tick-borne disease and associated chronic disorders where new infections are prevented and infected patients are rapidly and accurately diagnosed and restored to wellness with patient-centered, evidence-based, accessible, and affordable treatments and care.” The second one is shorter, “A nation free of tick-borne disease and associated chronic diseases where new infections are prevented and patients have access to affordable care that restores them to full wellness.” And the third one is, “A nation free of tick-borne diseases where new infections are prevented and infected patients have access to affordable care that restores health.” Now, based on the voting that people, when they sent me their preferences online, there was a general tendency to like the third one. And one thought that came up that isn’t reflected on this slide is to simplify it even further so that we delete the infected before patients. It would read, “A nation free of tick-borne diseases where new infections are prevented and patients have access to affordable care that restores their health.” So, that’s the background on the vision, and I guess we want to open it up here for thoughts and feedback from the group.
Ben Beard: Hi Kristen, this is Ben, and I like the third statement, because...just simply because I like something that is really short and sweet. It’s easy to wrap your arms around. And I also like infected, because that’s...removing that, because that’s implicit in patients, as far as I’m concerned. So, I kind of like that one. I could live with any of them, but I like that one the best. Thanks.
Kristen Honey: Excellent. Thank you.
Dennis Dixon: Yes. Dennis Dixon. Ditto. I like the simplicity, the clarity, and the crispness.
Karen Vanderhoof-Forschner: This is Karen, and I very much like the third statement, but I like them all. You did a great job.
Kristen Honey: It was teamwork. It’s definitely not all me behind the scenes.
Karen Vanderhoof-Forschner: Everybody did a great job.
Pat Smith: This is Pat.
Kristen Honey: Go ahead, Pat.
Pat Smith: I’m sorry, and I like number three. I liked it from the beginning, because it is definitely, I believe, what we are about, and it also is brief enough so that people can understand it at a quick glance. Thank you.
Karen Vanderhoof-Forschner: I have one question. Can we assume that “diseases” also means disorders like Alpha-Gal and tick paralysis? Those are not diseases, and I just don’t want to wind up in that quagmire where they’re not included, because they’re not diseases. Ben, do you have a feeling on this?
Ben Beard: I would actually say that they are diseases. I would say that they’re not infectious diseases, but I would say they’re diseases.
Karen Vanderhoof-Forschner: Good enough for me. Thank you.
Kristen Honey: Plus one, with that Ben. We had a couple of people nodding heads in the room here. So, I would like to make a motion to go with number three and dropping the infected so that our vision statement would be, “A nation free of tick-borne diseases where new infections are prevented and patients have access to affordable care that restores their health.”
TBDWG member: I second that.
Kristen Honey: So, let’s do a vote, and I think the easiest way to do this, since we’re not in the same place, is just go one by one. And I’ll go in alphabetical order. John Aucott.
John Aucott: Yes.
Kristen Honey: Wendy Adams.
Wendy Adams: Yes.
Kristen Honey: Ben Beard.
Ben Beard: Yes.
Kristen Honey: Scott Cooper.
Scott Cooper: Yes.
Kristen Honey: Dennis Dixon.
Dennis Dixon: Yes.
Kristen Honey. Yes.
Kristen Honey: Richard Horowitz.
Richard Horowitz: Yes.
Kristen Honey: Estella Jones.
Estella Jones: Yes.
Kristen Honey: Lisa Nigrovic. Oh sorry, Lise Nigrovic. (Silence.) She’s off traveling now. Allen Richards.
Allen Richards: Yes.
Kristen Honey: Vanila Singh. (Silence.)
Unknown: Her audio is having trouble.
Kristen Honey: Vanila, if you’re on...
Pat Smith: She’s got the same problem going on that I do.
Kristen Honey: Okay. Maybe you can email or chat box if it’s a yea or nay. Pat Smith.
Pat Smith: Yes.
Kristn Honey: Rob Smith.
Unknown: Not present.
Kristen Honey: Not present. Okay. And then Karen Vanderhoof-Forschner.
Karen Vanderhoof-Forschner: Yes.
Kristen Honey: Excellent. Thank you, all.
Rich Wolitski: We just got a “yes” from Vanila in…in the chat, so...
Kristen Honey: So, it passes unanimously for everyone present. So, I guess this is our new vision statement. Thank you, all.
John Aucott: Congratulations.
Kristen Honey: Now the mission statement. We’re running a little low on time. So, this is the present, today, and I think it’s the farthest one off. So, what I’m going to recommend is that we put a pen in this and continue to iterate. And I’m wondering if we might have a volunteer or two to take lead with the next round of the mission statement. If not, I’m happy to keep doing it, but I know that this probably needs the most work. Anyone who is really passionate about this mission statement and wants to scrub in and help out?
Scott Cooper: Hi, this is Coop. I’ll be glad to do it.
Wendy Adams: Kristen, this is Wendy.
Kristen Honey: One at a time. Sorry.
Wendy Adams: This is Wendy. Was this based on Scott’s changes or is this an amalgamation of the two?
Kristen Honey: It’s an amalgamation of the two. And then one other suggestion we had was to just take the top paragraph and drop the bottom stuff to keep it simple and easier to remember. So, Scott, do you want to...
TBDWG member: I like it as it is.
Scott Cooper: Yeah, I’d be glad to take it.
Kristen Honey: Okay. Why don’t... As a motion or next step, let’s have Scott Cooper take lead, and we can iterate online and then formally pass it next time.
Rich Wolitski: We’re one slide behind, right?
Kristen Honey: Oh sorry. Yeah, one slide behind. Sorry. We could go up.
Rich Wolitski: What first paragraph?
Kristen Honey: Yeah. Sorry. So, yeah, the other idea was just, Coop, was to have the first paragraph be it, and then the rest could be complementary, but maybe not formally part of the mission.
Scott Cooper: That sounds great. Yep. I’ll work with that.
Kristen Honey: And should we do a motion for that, or do we not need to formalize it?
Rich Wolitski: Yeah, probably not.
Kristen Honey: Okay. Great. We’re not voting on it. We don’t need to formalize that Coop is now point, but Coop, of course, here to help. Um, so the last one is core values, and we have 1 minute left, but I would like to run over a couple of minutes if we have to to get this right, because the values are what is going to help us day-to-day in how we operate, and what’s our North star compass and that unites all of us—the principles underlying how we work. The next slide, please. We had seven key areas come up. The first one... These are actually in reverse alphabetical order. We did not want to put any of the values more important than the others, so we started out having them alphabetical order and decided to reverse it, because then it...with accountability, the buck stops here on the last one. Make sense? Um, so do not take the order as any significance of importance. They’re all very important pillars. The first one is, “Respect: everyone is valued.” The second one is, “Innovation: shifting the paradigm, finding a better way.” The third one is, “Honesty and integrity: find the truth, tell the truth.” Uh, the fourth one, “Excellence: quality, real-world evidence underlies decision-making.” The fifth, “Compassion: finding solutions to relieve suffering;” and “Collaboration: work with citizens and patients as partners.” And lastly, “Accountability: the buck stops here.” We have some fine text and details that summarizes them at more length, and I think all the working group members have had time to see this and read it. And I’m not sure if we have to have those details so finalized. It was more the high-level values that I wanted to pass. So, I just want to open it up for discussion about these seven, and if people like them or if we’re missing anything or if maybe it’s too many and we want to streamline—all thoughts and feedback welcome, please.
Pat Smith: This is Pat. I think it’s perfect like it is, and I appreciate your effort on it.
Richard Horowitz: This is Rich Horowitz. I think it’s great, Kristen. I think people are going to be very happy when they see the core values of the group.
Pat Smith: Yep. This is Pat. I would like to say that I think this is a great thing that you put together. One comment though on the collaboration; if you do need to finalize the language down under that, the word “maximize” needs to be changed. It either needs to be “maximized or maximum.”
Kristen Honey: Great. Thank you. Any other feedback? (Silence.) Well, then...
Vanila Singh: This is Vanila Singh.
Kristen Honey: Go ahead.
Vanila Singh: It sounds and looks very good, Kristen.
Kristen Honey: Thank you. Well, I will make a motion that we pass the top-level ones as is, and that we, as a working group, online should feel free to iterate on the more detailed language describing those values. But at least these core values can be our starting point. So, do people want to adopt these core values for the Tick-Borne Disease Working Group is my motion?
Wendy Adams: This is Wendy. I second the motion.
Kristen Honey: Excellent. Then I will start going through alphabetical order for yeas and nays. John Aucott.
John Aucott: Yes
Kristen Honey: Wendy Adams.
Wendy Adams: Yes
Kristen Honey: Ben Beard.
Ben Beard: Yes.
Kristen Honey: Scott Cooper.
Scott Cooper: Yes
Kristen Honey: Dennis Dixon.
Dennis Dixon: Yes.
Kristen Honey. Yes. Richard Horowitz.
Richard Horowitz: Yes
Kristen Honey: Estella Jones.
Estella Jones: Yes
Kristen Honey: Lise Nigrovic. (Silence.) She’s not here, right? Oh, she’s on the line. Okay, great. She said, “yes.”
Kristen Honey: Thank you. Allen Richards.
Allen Richards: Yes
Kristen Honey: Vanila Singh.
Vanila Singh: Yes.
Kristen Honey: Pat Smith
Pat Smith: Yes.
Kristen Honey: Rob Smith.
Unknown Person: I think he’s not here.
Kristen Honey: Not present - Okay. Karen Vanderhoof-Forschner.
Karen Vanderhoof-Forschner: Yes.
Kristen Honey: Excellent. So, by unanimous vote for everyone present, we have core values. Thank you all. And with that, well, I would just... Yes. I am very happy we have a vision and we have core values to guide us every day. I can’t thank you all enough for your input. And Coop, we look forward to the next iteration. And we’ll get our mission solid. And then all of that will be our foundation for delivering an excellent report for Congress and the Secretary of HHS. And next up, I would like to introduce a scientist from the CDC, Anna Perea, who is going to be sharing with us some information that HHS and CDC have led already on Tick-Borne Disease Working Group, and she is visiting us, I believe, from headquarters down in Atlanta, Georgia.
Anna Perea: Hello, this is Anna Perea, and I am just working on getting my camera going here. Here we go. All right. Thank you very much. My name is Anna Perea, and I am a Policy and Communication Lead at the Bacterial Diseases Branch Division of Vector-Borne Diseases here in Fort Collins, Colorado. And I’d like to present some information today about the Health and Human Services Biannual Conference Call on Lyme and Other Tick-Borne Diseases. Um, the conference call was established on September 6, 2011, under the name, “Health and Human Services Internal Working Group on Lyme and Tick-Borne Diseases.” It is an informal group. It’s non-chartered. And the purpose is to foster continued coordination, collaboration, and communication on activities and shared interest relating to Lyme disease and other tick-borne diseases. Participation consists of HHS staff from operating divisions with responsibilities and activities related to Lyme disease, including various offices within the Centers for Disease Control and Prevention, Food and Drug Administration, NIH (National Institutes of Health), National Institutes of Allergy and Infectious Diseases (NIAID), and HHS’s National Vaccine Program Office. Um, the meeting consists of two meetings per year via conference call, and the typical agenda consists of brief updates from each HHS operating division or program, discussion of shared interests and activities, announcements of upcoming meetings and events, and action items and timelines if relevant. There are a couple of key activities that this group has focused on. There are two meetings or conference calls per year, and they’re only internal to HHS. And one thing that they do that’s more forward facing is jointly host an annual public webinar on various topics of interest related to Lyme and other tick-borne diseases. These have been archived and have received over 87,000 views to date. The archived webinars can be found at the bottom of the Lyme disease site, CDC’s Lyme site, under the header, “HHS Special Webinars on Lyme and Tick-Borne Diseases.” The key accomplishments of this group—and one of the main ones—is these webinars. And as you can see, there have been six or seven of them, and they have ranged on topics from Lyme disease persistence, two webinars on diagnostics, two webinars on model and emerging tick-borne diseases or updates on new tick-borne diseases, and another one on vaccines for Lyme disease (past, present, and future). You can see the number of views that each of these has received, and you can also see that the number of views does tend to increase the longer it’s been posted. Another key accomplishment of the group was to establish a 280 sample, well-characterized serum panel for distribution for investigators who are working on new diagnostic tests for Lyme disease. The samples were obtained by CDC with financial assistance from NIH in collaboration between CDC, FDA, and NIH, and a joint effort to make the process more simple and less costly for the development and validation of new Lyme disease diagnostic tests. As of 2016, CDC had released 85 panels to 56 individuals across 48 different institutions. Again, the group continues to meet twice a year by conference call under the modified name HHS All Federal Working Group on Lyme and Tick-Borne Diseases to avoid confusion with this federal advisory committee. Most recently, on February 2, there was a call, and during this time, the attendees decided that it would probably be in everybody’s best interest to not have a webinar this year due to many HHS personnel being involved in this FACA and time demands entailed with the hosting of the International Conference on Lyme Borreliosis and Other Tick-Borne Diseases in September. This is also going to involve a considerable amount of work, but we have every intention of continuing with the webinars next year. So, at this time, I’d be happy to help answer any question that might come up. Thank you.
Karen Vanderhoof-Forschner: I have a quick question on the grants that you have. In one of your prior publications that was the summaries of... I don’t know if you could see this. Let me put the phone down. I’m having trouble with volume.
Anna Perea: I can hear you fine.
Karen Vanderhoof-Forschner: Okay. Good. I’m turning the volume up so I can hear you. So, you had a book that had your plans 2 or 3 years out, and it talked about what grants you were going to give and where they were going to go for this year and next year. Do you still do that? Are all your... Do you have a list of grants that you plan to give in another year or two? And who sits down and sets those up? Do you have an advisory committee from outside grantees, for example, that get together and talk about what grants need to be out there?
Anna Perea: Yes. Thank you for that question. That question is not related to this twice-yearly call. We don’t discuss anything of that nature at these calls. So, perhaps there are other ways of answering that question, but it is not related to the topic at this time.
Rich Wolitski: And certainly, that’s part of what the inventory will get at is what the agencies are doing for funding and how they involve the community in those decisions.
Karen Vanderhoof-Forschner: Because I just don’t want to see us pulling out of one funding to do another. I know that, in talking with Director Fauci, he was big against tapping and it destroys budgets and projects. So, I just wanted to have an idea.
Kristen Honey: Well, I think we should probably focus that for a different conversation, but thanks for that, you know, like bringing it up as an issue, Pat, and we’ll be sure to address it later with our inventory and everything. Anna, thank you for the presentation.
Kristen Honey: Oh sorry. That was Karen. Okay. I apologize. Anna, thank you so much for that presentation. I’m curious how people find out about this working group and if it’s helpful to have more people. In particular, I’m thinking of all of the different fellowship programs and triple AS fellows who may be interested in, kind of, the next-generation of scientist or in federal government potentially getting involved.
Anna Perea: Thank you for that question. This has to be an entirely federal call; otherwise, it would be a FACA, and, you know, so it consists entirely of federal employees.
Kristen Honey: Oh, so federal employees. Not contractors and not fellows?
Anna Perea: Strictly federal employees.
Kristen Honey: Okay.
Anna Perea: And I have my mailing list, and it’s the same mailing list every time unless somebody retires or gets hired or whatever, but it’s the same mailing list.
Kristen Honey: Okay.
Pat Smith: This is Pat. I would like to thank you, first of all, and second of all, ask about whether that particular program is responsible for the Lyme Core presentations that were done, as many patients and advocates had great problems with the content of that program.
Anna Perea: No. Lyme Core was not related in any way to this group of people or this call.
Pat Smith: Thank you.
Wendy Smith: This is Wendy. Can you tell me how the decisions for what the webinar topics are going to be or made?
Anna Perea: Yes. The group typically has a winter meeting and a later-in-the-summer meeting. And during the winter meeting, that’s when the participants basically throw out ideas for what it should be based on...based on new findings, based on, you know, things that they think need to be covered. It’s a fairly informal process. People do toss out ideas and, you know come to a fairly quick decision in the group and then probably...typically, there might be a call to figure out who to have on each group or who to invite to the webinar, but the planning is fairly quick and straightforward.
Kristen Honey: And I think we just have time for one last question. Is there one more question out there? (Silence.) You answered all of them, Anna.
Anna Perea: Okay. Thank you.
Kristen Honey: Thank you so much.
John Aucott: All right. We’re going to move on now to our second speaker, Michael Farris who is going to give us a report on one state’s experience, and the Virginia experience in working in a collaborative fashion on Lyme disease and tick-borne infections. And he’s going to focus on the process and how they work and what made their process successful and not on the actual outcomes in terms of their deliverables, but the key first step, which is the actual process for achieving a working collaborative group. So, Michael, we’re very honored to have you with us today, and thank you for presenting with us.
Michael Farris: Mr. Chairman, Can you hear me okay?
John Aucott: Yes.
Michael Farris: Okay. Thank you for this opportunity. I deeply appreciate the honor of being here. And my aspirations for why I wanted to be involved have largely been fulfilled by listening, first of all, to your description of the first two sessions of your working group, especially the affirmation of the philosophy of doing a reboot and starting fresh and being people-centric and patient-sensitive and collaborative in nature. That was extremely encouraging, you know. Listening to your adoption of your core values and your vision statement all were extremely affirming and gratifying, and I think, basically represented the philosophy that represents...which is why I think our Virginia group was successful.
I prepared a number of slides, but I’m going to go through them rather rapidly, in light of the good work that you’re already doing. And basically, I just want to say a hearty congratulations and keep going, because I think you’re headed on a very important path on a very important issue. The reason I became the chairman of the commission in Virginia—and I apologize for the end being strained there, uh, on the website there, the areas for study and recommendation. But the reason I became interested in this is my family’s been seriously affected by Lyme disease, and when the governor asked me how I’d like to serve this administration, this is what came about. We looked at diagnosis, treatment, prevention, the impact on children, and public education, and we had separate hearings on each of those topics.
The task force was composed of 12 members. We had two cabinet officers from the state of Virginia: the Secretary of Health and the Secretary of Natural Resources. There were four medical doctors, including three from the Department of Health and including the state epidemiologist. We had one Lyme practitioner from outside the department. We had PhD school psychologist that was especially helpful in our analysis of children, a veterinarian, a clinical pharmacologist, the Secretary of Natural Resources. We looked at deer issues and, related to that, also fish and game. And then, we had three Lyme patient advocates and representatives, including me. We held nine hearings around the state: five were listening sessions for patients and families. And I would just recommend, as many opportunities, as you can to listen to patients and families, to be a very important component of your approach. They were instrumental in our ultimate conclusions. There were four hearings on specific topics. We combined two of the five into one hearing, and we had expert testimony on those topics. Diagnosis and treatment was one special session. Then we had prevention, impact on children, and public education.
Here are some of the general observations. I’ll be very brief. First is that this sector of illnesses is growing rapidly, and there’s much to be still understood. There’s a great need for more study, more science, and that’s consistent with that. We found that the disease is being under-reported, in part due to physicians not following through with their existing duties to report and other reasons, as well. I’ll let that stand for itself that there’s some confusion about the difference between epidemiology and diagnosis and an observation on testing that I’ll skip over. The important point is that public awareness on all fronts relative to tick-borne illnesses needs significant expansion. As you’ve been saying all today, this is my observation. The balance of viewpoints was essential to our work, and I’m very gratified by what I’m hearing from your work in that regard. Again, listening to patients and families was essential.
I’m gonna skip this observation in light of the rebooting comments that I’ve heard, and I just want to affirm what you’re saying in that regard very much, um, and I just simply... I came away saying there needs to be more science. If I had to have one conclusion that was my conclusion after a year and a half of hearings, listening to hundreds and hundreds of people, that we need more science in this area. And the unanimity is ideal. And if someone could help me with the technology, I’m just going to skip the rest of my presentation, because I think it’s cumulative of what you’ve been saying. Your unanimity on adopting the core values and the vision statement is reflective of what I’m hoping for, because Americans are suffering from these illnesses and people of goodwill can get together and talk about these to each oth...together. And given... If we’re open-minded and look at the science and look at the people, and with a compassionate open-minded heart, a look at these things, I think we can come together and that there is so much strength in coming together. And I think the strength of our report is that it was unanimous. So, thank you for this opportunity, and I’d be glad to answer any questions.
John Aucott: Thank you so much, Michael. That was just wonderful. I’m going to start with a question. You looked at children. Were there other vulnerable patient populations that were discussed besides children, and were there any unique aspects to the discussion of children?
Michael Farris: We didn’t have any other specialized focus on any other populations. It was, kind of, people in general and then a specific session on children. The fact that there were behavioral and psychological impacts on children was something that I didn’t anticipate and didn’t know in advance, and it was a very important component of it. So, I thought that those were important lines of discussion and really impactful. And so the head of the Loudoun County Public Schools Psychology Program was our committee representative, and she helped guide that in many respects and helped us understand that the important link between the physical aspects of the disease and the psychological, emotional, and behavioral symptoms that were being manifested in children.
John Aucott: I’ll open it up to the working group for questions.
Pat Smith: This is Pat. I would like to ask... First of all, thank you very much for your work, Dr. Farris. I’d also like to ask, did you get any feedback on the law that was passed in Virginia regarding doctors having to put out a notification to patients who got tested? Was there any kind of impact from that or feedback from that?
Michael Farris: Well, that legislative requirement was after our working group, and so the feedback I’d gotten on that is more anecdotal after the fact, and my... The anecdotes suggest that they’re...the compliance with that is sporadic, and so I don’t even know that doctors know that that is a requirement, frankly, on a practical basis. That was not a direct result of our task force, but I think it was in the wake of what we had done.
Pat Smith: Thank you.
Karen Vanderhoof-Forschner: I understand, and I’ve seen the forms that when they…, people get tested for Lyme, that goes from the lab back to the patient. So, it doesn’t go through the doc. it goes directly to the patient. And I’ve heard a lot of good things about that legislation. I’m impressed.
Michael Farris: Good.
Karen Vanderhoof-Forschner: Did you look at suicide?
Michael Farris: I think there was some testimony about that, but we didn’t do any special analysis on that. It was beyond our staffing and resource capacity.
Karen Vanderhoof-Forschner: And what type of educational programs did you put into schools or are schools using? Is it mandated?
Michael Farris: It is not mandated. Our report, um, ended with recommendations to the department, and so the department’s follow up on that, uh, it was... You know, we talked a great deal, for example, about informing schools of proper approaches for field trips. The kids go tromping through leaves and high grass on forest edge and so on, um, the need to be aware of the propensity of ticks to hang out in such locations, and so we talked a lot about preventative kinds of programs for schools to be able to...so that the school leadership and professional staff would know some of the environmental factors that could expose their students to tick-borne illnesses.
Karen Vanderhoof-Forschner: Excellent. Good job, guys.
Michael Farris: Thank you.
Pat Smith: This is Pat, again. Uh, is the state Department of Education on board with the recommendations that you have made, and have you considered recommending to them a state-adopted curriculum? In New Jersey, back in the 90s, we did get into place an actual state-adopted curriculum, and I wondered what your thoughts were on that.
Michael Farris: The... Our group ceased to exist upon the...our report that was issued in 2011, and so we had no ongoing... Well, we really never had jurisdiction other than to make a report, and so the State Department... There was a change of administration shortly after that, and things changed. The only carryover, frankly, was the Secretary of Health went from the writt...continued after the Republican administration, that I’d been a part of, into the Democratic administration. So, he carried some components over, but I don’t think there is a state curriculum. I think that would be a wonderful thing, and, of course, this...your working group could make recommendations in that fashion. I think it would be a great, great service to the country.
Rich Wolitski: And I just want to make a note. As folks ask questions, please identify yourself with your name, because even though the working group members all know each other—we’re getting transcripts—so we can identify people appropriately in the transcripts.
Karen Vanderhoof-Forschner: Just to comment, and it’s Karen Vanderhoof-Forschner, um, I was tooling around, and I happened to take a look at Maine. Maine is phenomenal. Maine has a children’s educational program that...and I was pleased to see that they’re very supportive of education in the schools. And they’re using—we developed it—but they’re using a CDC-funded puppet educational video, and it’s free for anyone who wants it. And they’re using it with some handbooks and curriculum guides, and they’re really on the forefront of this. In case you want to call someone, you can contact Maine’s Department of Health. Thank you.
Wendy Adams: This is Wendy Adams. I’m wondering if you looked at physician education or the consistency of, you know, evaluation done by physicians in the state.
Michael Farris: We did to some degree. I mean, there were a number of physicians. We received testimony mainly from patients that far too many physicians said, “There’s no Lyme disease in Virginia.” I mean, which is just contrary to everything. Um, but... So, the need for physician education is something that we did talk about and was a part of our report, but I’m skipping over the... You know, the report’s available online, and I think... I sent a link to it, uh, to the staff here. And so, I’m sure that they can get that to you if you’d like to look at some of the comments we made in that regard, but that’s an important component, indeed.
Wendy Adams: Great. Thank you.
John Aucott: One last question.
Richard Horowitz: This is Rich Horowitz. Regarding the impact, did anybody look at impact in pregnancy, the blood supply in Virginia? Has anyone looked at those modes of transmission?
Michael Farris: In the hearing on children, we did talk about that a lot. I was especially interested in that, because my wife has chronic Lyme, and we have 10 children, and 7 of our children have Lyme disease or have or have had Lyme disease. And so, there was some testimony about that, and we did look at that and looked at some of the things that the CDC had said about that. But you know, detailed conclusions on that score were beyond our capacity.
John Aucott: All right. Well, Michael, that was just spectacular. Thank you so much for your time and your experience that you’ve given us today. Just thank you so much. Appreciate it.
Michael Farris: Thank you so much, Dr. Aucott. I appreciate it.
John Aucott: All right. So, we’re going to move on in the agenda now, and we’re going to start to dive a little deeper into the work of the working group and subcommittees. And we’re going to start that by reviewing the roles and tasks of the subcommittee and the subcommittee members. I’m going to do, kind of, some broad strokes, and then I’m going to turn it over to Rich to get more granular on this. But just, sort of a Reader’s Digest version for people, is the subcommittees are really tasked with at least three major things.
The first is identifying gaps or opportunities or deficiencies or overlaps in the existing knowledge base and what’s going on in HHS. So, this is the chance to understand what opportunities exist for increasing our knowledge and research. We’ve been talking about knowledge, and research is so important, well this is... The first step is to, kind of, dive in and understand where the gaps are. Before we can do that though, we have to, kind of, have a list of our topics for each subcommittee. And the original list will probably be too big. And so, one of the things will be to narrow down the full list to some strategic highest impact aspects of the subcommittee. And some of these subcommittees have broad areas to cover, and so we don’t expect that you’re going to cover all 20 areas in the first 2-year project here, but we want you to be thoughtful about what the high priorities are, and then start to identify the gaps and the knowledge that will include looking at the inventories from HHS, you’re invited speakers, public input, again, which we’re planning through a town hall meeting.
And then the second big thing is, once we’ve identified those gaps or opportunities, is to start to trod out what paths forward there could be to make recommendations to resolve those or to improve on those. So, the second big area is looking at paths forward and recommendations. Our charter asked us to make recommendations after we’ve identified the opportunities. So, opportunities, then recommendations.
And then, the third big thing is doing the hard work for the working group. So, the subcommittees are really... You know, you are the hard work part of the first step here, because then you’ll put together a list of your meetings and what you’ve decided to pass on to the full working group. And that really is essential, because the full working group can’t do this for all six subcommittees at the get-go. The subcommittees will be doing that. And then it’s really crucial to understand that work will go to the working group, which is the only one that can put together and vote on and submit the final paper to HHS and Congress. So, it’s a process here, again, and that’s... Those are the main key pieces. I’m going to turn it over to Rich, now, to kind of get more granular with this.
Rich Wolitski: Thanks so much, John. And this is really... I realize, we had made an adjustment in the agenda by moving up the report to Congress, and this is really the part that was supposed to come right after the report to Congress session so that we could have a time for dialogue, questions, set you up in the right way to go into the subcommittee meetings, and discussions about the work.
So, we’ve covered some of this already in the presentation, but kind of, you know, to start, let’s talk about what the working group members are charged with doing, what the subcommittee members are charged with doing, and then what the HHS staff and our contractors are here to support you all in doing.
I mean, first of all, this really is the work of the working group, and so we are so appreciative to have the subcommittee members bring their expertise, bring their time, and their commitment to this effort. And we need you desperately. And so, we’re really looking forward to what’s coming out of the subcommittees, which, really, your job is going to be to provide the evidence, to do the work that leads us to identifying the articles, the experiences the providers are having, the documentation that helps us to better understand what the challenges are, what the problems are, and points us toward solutions. And I think that’s a critical thing to keep in mind as we do this work is that we’re wanting to move toward solutions.
So, we’ve given the co-chairs of each of the subcommittees some background information, some tools to kind of guide you through the discussion today, but I think first and foremost, the focus of the subcommittees is getting the report together that feeds into the working group and informs the working group about your opinions, your expert judgment about what are the things that are most important to address in the area that your subcommittee is tackling? You gather the information, analyze it, debate it, um, and then come up with what you see as the gaps, what you see as some of the opportunities for addressing the issues and challenges that you’ve seen, and kind of what you might see as ways of approaching the issues that would have the most impact, would benefit the most people, and would be the most efficient, or the most feasible way of going at it. And we’re imagining that you’re going to be, you know, looking at a wide range of potential solutions, which could be policy-based, changes in regulations or procedures at the federal, state, or local levels. You might be proposing the need for additional research in certain areas to address specific issues or changes in the way that things are communicated. Maybe everything is in place and exists but people just don’t know about it or don’t use it, or perhaps there’s a need for some more monitoring and enforcement of certain activities.
So really the... You know as you heard from the Virginia example they looked at a wide range of solutions to a wide range of problems, and that’s what we want you to do as well. We can work to, you know, kind of refine this. We’ve given kind of a general outline to you today for how to look at the report and the general topic areas that we wanted you to consider. With regard to evidence, we’re leaving it to the co-chairs and the subcommittees to figure out the best approach to pull together the information that you...that we need to see in the working group. So for example, in some cases you may already know who some of the experts are in the field that you want to hear from. You’ll be able to schedule your own meetings that work for the time of your committee members and you’ll be able to invite speakers as you see fit who will be able to present evidence and information to you. That becomes part of the public record when it is turned into something that goes to the working group. So everything that happens within the subcommittee is initially treated as nonpublic. Those are not public meetings and folks are asked to keep the information about what happens in the subcommittee meetings confidential. And we’ll talk about what is required to be reported out on those meetings. We’re not going to hide that the meetings are happening and the things are going on. We will be producing a summary that documents basically when your committee has met, who was present at that meeting, what the topics were that were discussed, and if there are any external people who were invited to participate, we’ll need to identify them as well. And so we’ll follow up with co-chairs, as you get ready to start planning your meetings, what information will need to be documented.
We are asking that, for the co-chairs, that we set up some standards for calling meetings. One of the things that we think is important is that, you know, when you’ve got a subcommittee that everybody has an opportunity to participate. So we’re asking that people schedule meetings ideally at least 48 hours in advance, but a minimum of 24-hours-notice on meetings and when you have meetings, every member of the subcommittee needs to be notified that there is a meeting. And in addition to that John and Kristen should be copied on meeting information as well as myself and Jim, so that we have it connected up to the larger process. And I know John and Kristen have kind of divided up the groups. And so you’ll be splitting them between the two of you in terms of who you’ll be working with most closely.
In addition to... And concerning the subcommittee meeting, you have to have either myself or Jim or a delegate on our behalf present, and that was one of the challenges of setting up the meeting today is that you cannot have a subcommittee meeting without having the DFO or representative of the DFO present, and this is to make sure that everybody is staying...everybody is in the loop and that we’re kind of working towards the common goal. If I’m not available, I will make certain that, you know, Jim and I find a suitable alternative to be there as a resource for you and then in addition, there’s one last resource step I want to mention. Communicate Health and Kauffman and Associates are under contract with us to help support the work of the working group and there will be a writer that is assigned to each of the subcommittees. There will be…one writer will take responsibility for two of the subcommittees at a time, and the writer will be there to attend your meetings, take notes, and will help you with the production of your report to the working group. And so I’m going to pause there and let John and Kristen identify the groups that they’re going to be working more closely with, and then I’m going to turn it over to Jennifer Gillissen from Kauffman and Associates to talk a little bit about the support they’re going to be able to provide to you in the writing.
Kristen Honey: Sure and we’ll work with HHS to update the webpage with the subcommittees so that this information is public and online so you won’t have to remember it or there won’t be any guesses from the public. So we basically decided that it would be nice to have one point of contact, either the chair or vice chair, to reach out with if any issues come up or anything. Of course, you’re more than welcome to reach out to either John or I, but in terms of the three subcommittees that I’ll be the leadership point of contact, it’ll be “disease vector, surveillance and prevention” with Pat Smith and Ben Beard. It will be “testing and diagnostics” with Lise Nigrovic and also the new federal member when we know that person and then, also lastly, my third group is the “access to care services and support to patients” with Karen Vanderhoof-Forschner and Scott Cooper.
John Aucott: Great. And I’ll be working with “pathogenesis;” “vaccine and therapeutics;” and “other tick-borne diseases.” So I’d like to give the working group a chance now to ask any questions to Kristen or myself or Jim or Rich. So I’m going to open it up for any questions. Again, please identify yourself before the question.
Rich Wolitski: And we’ve got a good amount of stuff to cover still, but for the things we’ve covered up until now, any questions on these issues. And I’ll let Jennifer talk a little bit about the support the writer will be able to give to each of the groups.
Pat Smith: This is Pat. I have a question and I don’t think you’ve answered it, but I apologize if you have. When we solicit the information from the federal government, if we don’t get the information that we expect for our committee even though we’ve, you know, made every effort to include things that would elicit that are we going to be able to give the agencies an opportunity before the report is written to come back and provide us with what we need?
Rich Wolitski: Yes, so certainly we will, to the best of our ability, follow up with people to say, “Wait, you know we asked this question and you gave us this, which really wasn’t what we were after. We were after...” We’ll try to work through those things. I think in many cases what we’re going to find is that the way that we would like the information to be able to be reported may not be exactly how it’s kept in their records and so... You know, I know from doing inventories on other things before that it’s hard for the agencies to report things out in a way that *** (indistinct )
Unknown: When would I know when it’s my turn?
Rich Wolitski: So when we... You can wait. When somebody is finished talking and then you can jump in would be a way to go. And I mean Pat we’ll do our best. I think this time around for the first report because of the timeline, we’ll have to push hard to get the information back in a timely manner. And quite frankly even that’s going to be a bit of a struggle. When we looked at what we thought was basic and needed for the inventory, it already looks like a lot, and I can see that folks are gonna really squirm and not be happy about being asked to provide this much information, but I think that it’s important enough that we’ll be able to get it but it’s going to take a little bit of work to make it happen.
Kristen Honey: And let me just build on top of what Rich said. This is Kristen, and part of the reason of having federal co-chairs with the non-feds is that we envision this as being an iterative process and with weekly deliverables; it will become clearer as we refine the schedules and all. Every single week you have a touch point with seven feds who can help with this. So we aren’t imagining that a report will come and that it will surprise the agency because we didn’t get specific information, but it really will be many touch points maybe on a weekly basis or a monthly basis, but frequent conversations as we go along.
Rich Wolitski: Someone else was trying to get into the conversation with a question. Who was that, sir? (Silence.) No. Okay. Anything else at this point? The other things that I’m going to cover real quickly is we’ll talk about the support services of the writer. It took a little bit more... Let’s see if you have questions about the outline for the subcommittee report and talk a little bit more about the inventory for sure and how that’s going to work, because we need to get that from you today and then just touch on real briefly that we have a planned national town hall meeting that we would like to use as an opportunity to get input for your work in each subcommittee. And so those are the kinds of things that were on my agenda for covering with you today.
Wendy Adams: This is Wendy. Can I ask a question, please?
Rich Wolitski: Yes.
Wendy Adams: Is there a statutory reason we can’t do meetings on weekends? I don’t want to scare my subcommittee members, but I just am asking in case that becomes a convenient time given how many... You know I think a lot of subcommittees have a lot of treating positions which is hard to schedule them during the day, understandably, and then is there a, like a quorum we have to have or are there statutory limits as to if we need to have one person off one subcommittee meeting because it’s just unavoidable, what are our... What are the regulations there, please? Thanks.
Rich Wolitski: You’re going to be relieved to hear that there are not the same regulations that govern the working group itself. The working group is the FACA. The subcommittees are a separate entity that is not... They’re not governed by all the same rules and procedures as the FACA. So you can schedule meetings on weekends if that’s what works best for everybody. You can... There’s no rule for the quorum. If it’s been a meeting that’s been announced and there’s been enough time set for all of it, that would be fine, but I would note that we do particularly for... When you’re getting to the point of having products that are finished, you know we do want the subcommittee to take a vote that this product that’s being ready to go forward to the working group is acceptable and meets the discussions and spirit of the subcommittee. So let’s say, if it’s on a day that, you know, most people aren’t going to be there, that would not be the best day to have a vote on something, but you could work out an alternative arrangement for people who aren’t there to send in an email, saying they’ve reviewed it and they approve it for submission, that kind of thing. So we’ll, kind of as we get going, I’m sure they’ll be questions that people have and we’ll sort of like a living document of some tips for the subcommittee co-chairs the members.
Karen Vanderhoof-Forschner: So I have a question....
(Several people speaking at once - 01:21:46.)
Rich Wolitski: Okay. Go ahead.
Karen Vanderhoof-Forschner: I have a question. It’s Karen Vanderhoof-Forschner. If we have a meeting on a weekend, we need either James or Rich on that call.
Rich Wolitski: Yes.
Karen Vanderhoof-Forschner: Okay. I just wanted to make sure. And what about the support staff with your subcontractor that’re working on this? Do we do it as a video call? Do we do it as a group phone call arranged by you or...
Rich Wolitski: Yes...
Karen Vanderhoof-Forschner: So how do we do that?
Rich Wolitski: Yes, so one of the things we’re going to follow up with people on after this meeting is the extent to which having the webinar support was of value to you and something that you think would be important for your subcommittee to take advantage of or whether you think just kind of an old-fashioned conference call and emailing documents would be more appropriate for you and the work that you envision for the group. We can do either, I think. We’ve got some cost issues that we’re working out on the webinar stuff, but we’re going to do our best to make it available to everybody who wants it. So I’m available on weekends. Weekends are actually a good time for me because I don’t have meetings on weekends for the most part. So I don’t mind that at all. What was the other question? Karen, what else did you want to know?
Karen Vanderhoof-Forschner: Support staff.
Rich Wolitski: Oh, support staff. I think it’s a good time for Jennifer...
Karen Vanderhoof-Forschner: But Wednesdays are okay with either of you?
Rich Wolitski: So let’s kind of do that scheduling stuff later. So Jennifer, why don’t we jump in and give you a chance to talk a little bit about, um, some of the support services that you’ll be able to provide and any parameters that you have on that. Like I don’t know what the schedule is for your writers, for example.
Jennifer Gillisson: Yes. So this is Jennifer with Kauffman and Associates. I’m part of the Communicate Health team, and so as part of, as Rich had mentioned, as part of our support we will providing one writer for...who will cover two subcommittees. We will send out a Doodle Poll so that we can try to see as many people as possible can get on to the calls. Each writer will take notes. They will do a summary and that summary of the call will be done within 2 business days. We will also make that summary 508 compliant within 10 days, to be posted on the Tick-Borne Disease Working Group website so that you can track what is happening in the subcommittees. Our writers will also assist with any sort of presentation that would be done, which would be the 25 maximum, as well as 50 pages for the report-out to include references, tabular data, existing documents, journal entries, et cetera.
What we will also do is have a SharePoint site. We have a subcommittee folder set up for each one of the subcommittees. Our writer will go through and upload all of the minutes, articles, papers, documents, whatever is needed for each of the subcommittees to be able to view. So each subcommittee has their own folder and each of the subcommittee members will get access to that. You will get an email from me later on with the link to SharePoint to your subcommittee folder. We will also help put together an outline that the chair, vice chair, and input from the DFO and the working group members have approved and that’s the template that we would use moving forward for the report. Each writer has about 100 hours to work with the subcommittees to be able to produce this information. As far as working on weekends, I’m not really sure I can answer that question fully right now.
Rich Wolitski: Thanks, Jennifer. And so one of the things I do want to kinda point out is that, you know, there are some resource limitations on our end in terms of how much the contract can support and how much we can support. If people run into issues with it needs to be 60 pages instead of 50 pages, we’ll figure a way to work some of that out with you, but the time of the writer is going to probably be the place (indistinct ) here. You’re gonna want to be most mindful in terms of how you use those resources when it comes to actual writing of the report. And what I’m envisioning is that when you all get ready to have your first meeting with your subcommittee outside of today’s meeting that, you know, myself or Jim, whoever’s going to represent HHS and either the writer or somebody from Kauffman and Associates might be a good time for us to talk a little bit more specifically and in depth about what it is you want to do and how we can support you. So I imagine if you get started there’ll be questions and issues that you’re not anticipating today, and we’ll go ahead and put together some more information we can send you in writing. One of our challenges is, it would be ideal to be able to say, “Oh, let’s just have a call later in the week with all the co-chairs and let’s talk about the process and nail it all down that way.” Unfortunately, you know we’re not able to do that because of FACA regulations. So we will be able to talk to individual subcommittees and talk with you about this type of support with you in that way as a subcommittee, but not bringing everybody together just any weekends, because of FACA regulations. But we’ll put some more information down on paper about how you can request literature reviews if you want to do a literature review, more information on paper about the SharePoint site. And just to clarify, Jennifer, we’re not going to be putting information about the subcommittee members on the public website, the HHS Internet site, except for some of these very kind of short summary documents that document that a meeting has occurred and what the topics were and who was present. I think what you are talking about was more the SharePoint site where people will be able to get all the records and the minutes from the meetings at that time. And maybe we’ll come back to that and talk about whether we do want to make the full minutes available. That has not been a formal decision that we’ve made yet. Okay. Anything else about questions about the process of support thus far? (Silence.) So we’re going to basically be presenting you with a timeline, as well, which I’ll show you in a moment if there aren’t any more questions. And then we’re going to have to move off of this and then we’ll do follow up. I’m envisioning that folks will want to have a one-on-one call either with me or Jim or somebody to kind of work through the specifics of it as you get going and with Jim and Kristen, as well. That will be... They’re, of course, available and welcome to be part of that process, but they may not have all the time to be on every single call. So, anybody want to ask anything or do we want to look at the timeline real briefly?
Unknown: Do we want to move on to public comment?
Rich Wolitski: So... I could tell you what. I will mail... I’ll email folks the timeline, because we are hitting on our public comment time. We do want to respect the time of the individuals who have taken away from their schedules to be here with us today. So the detailed timeline, that kind of breaks that almost week by week, what things are that we would hope to be able to get back from the subcommittees and we’re doing this in part so that you have a task that isn’t just one giant task that at the end it takes a Herculean effort to get done. So rather we can do it in pieces, and if there’s adjustments that need to be made to the products, we can do those while they’re still small pieces, rather than having a whole big giant report with 50 pages of stuff to try and modify in some fundamental way. So, I’m going to go ahead and stop here and we will go ahead and go to public comment. And then we’ll come back to process from there. So who am I turning it over to, John or Kristen?
John Aucott: So we’re making a transition now to the public comment that will be obviously a virtual comments and that will be handled by the group here. There’ll be eight people speaking. We want to remind people that we have to keep the time limit fairly strict to the 3 minutes per commenter. And let me go ahead and turn it over to the operator who is going to actually assist the individuals doing the comments.
Phone Operator: People may now provide public comment. The order in which they’ll be introduced is Julia Wagner, Beth Carrison-van der Heide, Jennifer Burton, Gary Sweeney, Timothy Opiela, Jennifer Platt, Jena Blair, and Kathy Nodolf. Each will have 3 minutes to speak, 15 seconds before the 3 minute time, you will hear an alarm. At three minutes, the phone will be muted, and I’ll proceed to the next speaker. The first speaker is Julia Wagner. Go ahead please.
Julia Wagner: Good afternoon. This is Julia Wagner, and I am the president of PA Lyme Resource Network, which is a 501(c)(3) in Pennsylvania providing outreach support and education and advocacy services to both the general public and the medical community in Pennsylvania. I have provided testimony as a background to all of you. It was provided in the PA Senate this past October. So please refer to that for more detail. I would like to make three comments, three points and this is all based on the experience of our organization with over 8 to 10,000 patients annually in Pennsylvania, and it represents their point of view and it also represents my point of view as a parent with three children afflicted by these diseases, and personally as someone who became dementia-like because of these diseases—and with appropriate advocacy by ourselves and access to resources reversed that and quite high functioning today. So with that said, the first point is that in argue the situation is quite serious. Pennsylvania, as you know, is number one in reported cases and continues to increase. The large percentage are children through young adults and what we have seen in recent years is extremely concerning and that is an increase in death count. Over the last year, we lost a 25-year-old, a 29-year-old, a 3-year-old, a 50-year-old, a 50-year-old with two young children, and a 39-year-old. All of these would not in any way be confirmed due to tick-borne diseases without the intervention of their families working with the coroners to make sure that the cause of death was reported. So, we are not in any way tracking deaths associated with tick-borne diseases in Pennsylvania, and I think this is key. The impacts are serious. This organization started by parents whose children were affected and saw neurological, cognitive, and psychiatric impacts that when properly diagnosed and treated were completely reversed. We all know that the roll-up of that in terms of quality of life, in terms of cost, societal cost, and individual cost is very high and if just a small percentage of some of these serious diseases can be reversed, it behooves us to take those actions. So in our view, the situation is very serious. Related to this is number two and that is that short-term action that in fact are low-cost are needed and are within your reach to shift the perception of this disease. In Pennsylvania, we are very focused on prevention and awareness programs and are funded by the Department of Health to want the first prevention program. We believe that the language about this disease needs to shift from it being benign to being potentially quite serious. That will allow departments of health to take action... (Audio cut off )
Phone Operator: Your next speaker is Beth Carrison-van der Heide. Go ahead, please. Your line is open.
Beth Carrison-van der Heide: Thank you for allowing the four Alpha-Gal advocates to comment today on behalf of the thousands affected by Alpha-Gal Syndrome (AGS) across the U.S. and worldwide. In the comments by Beth Carrison-van der Heide, Jennifer Burton, Tim Opiela, and Dr. Jennifer Platt, we’ll take this opportunity to share with you the concerns and experiences of the AGS community. We’ll present many significant gaps involving the Lone Star tick, which is associated with at least eight diseases and conditions identified by the CDC. The facts presented should be of keen interest to all here today, all of which are transferable to all of your six working group committees and their affiliations. Facts to consider: Lone Star ticks are found in over 1,300 counties and 39 states and growing in the U.S. according to the CDC. A 2017 report recorded in the U.S. National Library of Medicine confirmed Alpha-Gal IGE reactivity to Lyme, Borriello, and Xiodes Rickettsiosis. AGS is known to stem from six other ticks worldwide. This puts the U.S. citizens in our active Armed Forces at risk. The following highlights have far-reaching impact all stemming from AGS, which, again, remains unmonitored. That’s from social and economical consequences, U.S. healthcare system, education awareness, and treatment materials. Also the need for accurate FDA recording and labeling and the safe procurement in manufactured goods imported and exported worldwide. The potential for the spread of infectious disease due to our inability to participate in many vaccinations, liability and financial burdens to the public schools and employees since AGS is covered by the American Disabilities Act. Many children are at risk and many are currently experiencing daily reactions, including anaphylaxis, while at school due to exposure to simple items containing mammalian ingredients, such as glue, crayons, as well as airborne reaction to dairy, covered pizza, and beef burgers while they’re cooking in the school. The livestock industry is also affected since AGS households often eliminate all mammalian foods and products, including dairy and lastly, but not limited to, decreased acceptance in the U.S. and Armed Forces due to our inability to receive mandated vaccinations and the risk surrounding AGS. In closing, thank you for expanding the language here today, which will now include Alpha-Gal and other conditions in the discussions, research, and review of the working groups scope. For the record, I am diagnosed with both Alpha-Gal and Lyme disease, which were left undiagnosed for 15 years and 3 years, respectively. In both cases, I self-diagnosed before being properly diagnosed by my physician. My husband and my son both are affected by Lyme. *** (beeping sound - 01:36:39) reported with evidence to you in the email. Thank you.
Phone Operator: Your next public comment comes from the line of Jennifer Burton. Go ahead please.
Jennifer Burton: I was diagnosed with Alpha-Gal Syndrome after months of battling the common escalating symptoms of AGS—extreme fatigue, joint pain, rashes, vomiting, diarrhea, GI distress and bloating, angioedema, urticaria, and four anaphylactic episodes (two nearly fatal). I want to address the gaps in the medical, pharmaceutical, emergency services, and food industries not only for those of us with AGS, but for others afflicted by tick-borne illnesses. Gap: better education and resources for the medical industry regarding the 20 plus tick-borne illnesses and their symptoms; questioning patients that have been recently bitten by a tick; not doing so with patient’s lives, their quality of life, and results in months or years of improper patient, institutional, and elder care, medications, medical, and insurance bills, and personal financial losses. Once study sites 43 of those with AGS were self-diagnosed. Many are diagnosed with one tick-borne illness and then years later diagnosed with two or more. This is true for my patients with AGS and with AGS patients with latent Lyme. The majority of doctors send AGS patients away with instructions, “Just don’t eat beef or pork and it will go away in 2 to 5 years.” Current statistics show only 1 in 300 go into remission and, if bitten again, the reactions return and worsen. AGS is a tick-borne illness that is life altering and life-threatening with many adverse reactions, badly afflicting many children. Gap: education for first responders, paramedic and emergency room personnel, especially in anaphylactic cases. Many of us have nearly died from improper treatment due to the lack of AGS knowledge, improper diagnosis, and drugs that were administered that contain mammalian byproducts. Gap: educating pharmacists. One article sites, “Pharmacists should be cognizant of patients presenting with anaphylactic systems and with a history of exposure to ticks,” but the majority of us adjusting meds and supplements containing gelatin capsules, lactose, whey, magnesium steroid, and other mammal sources keep our systems constantly agitated and has caused anaphylactic reactions. Gap: accurate and full disclosure of all ingredients in food labeling; for example, natural flavorings with spices which could contain mammal source ingredients. This alone would allow millions with food allergies and those of us who react with trace mammalian sources the ability to avoid it. Conclusion: there are many gaps, but the key for education, awareness, and prevention not only in the medical field, but throughout the general public; without those keys the number of people with the tick-borne illnesses and deaths will only increase exponentially just as tick and the pathogens they carry have. Thank you.
Phone Operator: Your next public comment comes from the line of Gary Sweeney. Go ahead please.
Richard Wolitski: Hi, this is Rich Wolitski. Just let me jump in real quick, one second, and explain to people. When you hear that alarm sound goes off, it means that 15-second warning, and then the operator will close down the line at the time limit, and so I just want to warn you and explain what’s going on there. So, I apologize for abruptly cutting people off at the start. Okay, go ahead, Gary.
Gary Sweeney: My daughter has been stricken with Lyme for over 10 years. Our story is similar to many others presented here. Our healthy high school daughter experienced extreme fatigue, joint pain, and brain fog. Over months, many specialists were consulted. A positive IGM Western blot was dismissed as false positive due to durational symptoms. We were told by almost all of our doctors, Lyme does not exist in Georgia. A few doctors suggested psychiatric counseling. Almost a year into searching for a diagnosis, our daughter’s symptoms worsened. We went out of state for a doctor educated in diagnosing and treating Lyme. Initially, oral antibiotic treatment was followed by IV antibiotics for 6 months. After treatment, there was significant improvement, but it came at great monetary expense due to insurance denials. With often, occurrences of symptoms, our daughter earned *** (indistinct) despite symptoms and treatments affecting her, our daughter struggles to live as normalized as possible. Currently, she is in treatment for extreme fatigue. At times, life is difficult for our family. Experiencing life with a child who continues to suffer 10 years past diagnosis, I find myself with many pertinent and important questions regarding diagnosis, treatment, and the basic biology of spirochetes that I want to present to the ***, (indistinct) “Why are victims and their families told Lyme does not exist in non-endemic areas? Are black-legged ticks the only vectors for Lyme? What about Lone Star ticks? How do *** (indistinct) and changes in expression of outer surface proteins interact with the immune system? Is it possible the immune system is severely down regulates to allow viral and other biological opportunistic *** (indistinct) to thrive?” (Silence.)
Unknown: We’ve lost you.
Unknown: He dropped the call.
Phone Operator: And your next public comment comes from the line of Timothy Opiela. Go ahead please. Your line is open.
Timothy Opiela: Hello, and thank you for allocating this opportunity to speak to you about an emerging tick-borne disease known as Alpha-Gal. My name is Timothy Opiela. I’m from Pittsburgh, Pennsylvania. I’ve been researching and educating victims of venomous Lone Star tick bites for the last 7 ½ years, including parents with children with Alpha-Gal. My research commitment for Alpha-Gal stems from my daughter being bitten by a Lone Star tick, which gave her Alpha-Gal at age 6 in 2010. At that time, she was a healthy figure skating champion with Olympic dreams. An observation of the rapid geographical spread and sheer number of newly diagnosed Alpha-Gal cases, especially amongst children, I have to wonder, “Are we at the evolution, the cusp of the creation of a new Alpha-Gal generation of children?” As you may or may not be aware, Alpha-Gal is not limited to just ingestion of meats and/or byproducts. It’s much more pervasive and encompassing. The area I’d like to focus on is the impact of vaccines on children with Alpha-Gal. AG children are not able to be safely vaccinated for many of the recommended and required vaccines, because they are grown in mammalian product or byproduct, such as gelatin. A review of 61 vaccines deemed important by the CDC, 38 contain mammalian-derived ingredients, for many of them unsafe for children with Alpha-Gal. This means only 37% of the vaccines potentially safe to administer to a person with Alpha-Gal leaving unprotected and preventable diseases 63% of the time. Due to gaps in research and because Alpha-Gal children are not vaccinated, exposure to infectious disease will affect everyone here in the United States. Last year alone, our daughter, along with the sons and daughters of other people...kids with Alpha-Gal were not able to receive vaccines, such as HPV, Tdap, and meningitis. These are not vaccines we want to have administered to our children, but simply safely could not. By not being able to have a growing... By not being able to have a growing number of Alpha-Gal people vaccinated, gaps the infectious disease pathways and becomes an obvious risk for the general public. Alpha-Gal and Lone Star tick populations, such as in the Long Island, New York, Charlottesville, Lynchburg, Virginia, and Chatham County, North Carolina, with record numbers of Alpha-Gal cases become now breeding grounds for an increase of infectious disease potential both now and in the future. I request for this well-respected committee to include Alpha-Gal (beeping sound - 01:45:12) as part of the emerging tick-borne disease conditions and national efforts to prevent gaps of future spreading of infectious diseases. Thank you for your time, review, and consideration.
Phone Operator: Thank you, and as a reminder, for those, once you hear the alarm, there is 15 seconds remaining. Your next comment comes from the line of Jennifer Platt. Go ahead please.
Jennifer Platt: Thank you. I am the CEO and founder of Tick Warriors, a private company based in Chatham County, North Carolina. Chatham is a widely recognized hotspot for illness in both North Carolina and the U.S. In 2011, while I was working on my doctorate in public health from UNC, I contracted Ehrlichiosis and was later confirmed to also have Lyme and Babesia. In 2015, I worked with our local health department to conduct an exploratory survey about exposure to ticks. 94% of respondents indicated that one or more people in their household were exposed to a tick within the previous year. Subsequent surveys yield similar results. Our exposure in Chatham is more than doubled the national household exposure average of 45%, according to a 2015 CDC study. Tick-borne illnesses are not rare here, but we can’t track or validate the impacts of AGS and other “conditions,” such as STARI, heartland virus, and tick paralysis, because none of them have a specific ICD-10 diagnosis code. In the southeast U.S., five species of ticks bite humans, more than any other region in the country. At least 11 associated human pathogens have been identified. Any tick can cause paralysis. When patients are *** (indistinct - 01:47:02) to have at least one pathogen, more complete testing at all is desperately needed. I urge you to read the letter to the editor in this month’s CDC’s Emerging Infectious Diseases Journal, which discusses the spread of the Lone Star tick into the northeastern U.S. and raises more issues than I can address here. One critical issue is the complications of using the presence of EM to diagnose Lyme disease. There is the possibility that LD case numbers are inaccurate, because the Lone Star tick bite can also produce an EM. This may help explain why growing numbers of Lyme patients are discovering they react to red meat; clearly AGS goes way beyond problems with eating red meat. For many reasons highlighted, mis-diagnoses run rampant. As experienced by those with Lyme disease for decades, AGS patients are also invalidated by their health care providers and loved ones. The consequences: emotional, economic, social are devastating. Thank you for your decision to include AGS and other conditions in your report. For additional emphasis, you may want to consider expanding the charter language (beeping sound - 01:48:24) and vision statement to tick-borne diseases and conditions. I thank each and every one of you for your commitment to this initiative. We all bear the burdens of tick-borne illness and owe the full picture to ourselves, individuals, and taxpayers. Any less is not acceptable.
Phone Operator: Your next comment comes from the line of Jena Blair. Go ahead please.
Jena Blair: Hi. Thanks for having me on today. First off, I’d like to remind the working group that Borrelia or relapsing fever germs and just like the rest, they’re capable of antigenic variations. That fact alone makes it a ridiculous notion to attempt to vaccinate against it and asinine at best to say that vaccines for spirochetes work by turning human blood into tick-borne (?indistinct - 01:49:06) infestations. Secondly, OspA panthresis, (spelled phonetically) a fungal-like endotoxin that causes immune suppression and that means that it is the opposite of a vaccine. For the last 18 and half years the activist group Action Lyme and now Truth Cures has been filing complaints with every dot gov agency anyone can think of. This was even brought to the FDA formally that OspA causes immune suppression and a systemic disease *** (indistinct - 01:49:31) and I’m directly quoting here from a patent owned by David Pershing and Robert Schoen who say that OspA causes a disease indistinguishable from late chronic neurologic Lyme, but never once has any dot gov agency or MD answered the question as to how OspA allows the same exact multi-system protein disease, no spirochetes same disease. The science was settled as far back as 1986 when, for example, Paul Duray who is a top Army pathologist, reported that the lymphocytes in spinal fluid look like leukemia or lymphoma and appeared to be Epstein-Barr transformed. Also, in the 1980s it was Allen Steere himself who reported that this was like pseudo-lymphoma. Gary Wormser has reported that OspA causes immune suppression, three times now. So, do we really not know anything about relapsing fever organisms? Post-treatment Lyme disease syndrome or chronic Lyme, or whatever you want to call it is really an Acquired Immune Deficiency or what the NIH calls post-sepsis syndrome. Everyone says so. There is no question. Every subcommittee needs to be viewing the disease through the lens of this really being a B-cell 8. The only way forward is for HHS to admit the role of OspA as a self-disabler. OspA could have never been a vaccine; it never was and it never will be, because it is a fungal-like endotoxin. Spirochetal diseases are not easily treatable infections. They are acquired immune deficiency detonators with a cancer-like twist. We demand that you answer as to what the structure and function of OspA is and that alone will give you the foundation to squash all of the controversy. If this committee fulfills its intended purpose altruistically, you will look at the existing science to validate what is really going on with Lyme disease and you will recommend a criminal prosecution and stop the madness. TrueCure.org has all the data in our chart sheet. Thank you.
Rich Wolitski: Operator? I think we’ve got one more commenter, is that true?
Phone Operator: And the line of Kathy Nodolf. Go ahead please.
Kathy Nodolf: Good afternoon. The biggest complaint I have about the crazy controversy regarding Lyme disease is the vehement denial of facts, truth, and the real science that exists today. There is only one truth, not tailor-made versions of it, to suit each and every one of us. This committee will have failed everyone if the U.S. government does not state for public record what exactly OspA is or Outer Surface Protein is and what its structure and function are. The answer to this will cut to the chase and answer all other questions. If we know what is a fungal endotoxin that causes immune suppression, then we can end this false dichotomy over persistence and antibiotics. Killing spirochetes is not the answer to this disease. There has been a crime committed here. The crime is a falsified case definition of Lyme disease. We demand prosecution of the individuals who are responsible for changing the case definition at the 1994 Dearborn Conference chaired by Barbara Johnson of the CDC and aided by Alan Steere’s research fraud used to falsify the case definition. This conference facilitated the approval of the science...of the since failed LYMErix vaccine, which has been pulled off the market for causing the same multi-system disease as those of us suffering from neuro-Lyme. OspA within the vaccine and OspA and other lypoproteins like it are shed with blebs or other exosomes by spirochetes. Spirochetes cause disease by going straight to the germinal centers of our lymph nodes; these are worked on by Nicole Baumgarth and Steve Bartell. The current testing makes absolutely no sense when you understand that Borrelia are relapsing fever germs. Borrelia is differentiated by their flagellum genes or DNA. Since all relapsing fever organisms are capable of antigenic variations, they can change their outer surface protein as a way of evading the host’s immune system. The only scientifically valid way to test for Borrelia infections would be to test for flagellar antibodies instead of outer surface proteins, because it is specific and it never changes. Testing for so many antibodies all at the same time is not logical or valid by any standards. Erol Fikrig and Flavell did a test in 1991 patent number 5618.533, which is 94 to 95% accurate during all stages of the disease. This is obviously the test that should be used. Until we get the correct definition of this disease, we will never find a cure. We have wasted too many years and too many dollars trying to fix a disease that is currently defined incorrectly by design. I am tired of watching my friends die and suffer a torturous life due to this crime. The insanity of it all needs to stop now. Go to TrueCures.org for the scientific validation needed to prosecute this crime.
Rich Wolitski: And this is Rich Wolitski, again. Operator, if we’re able to get Gary Sweeney back on the line, um, we’ll go ahead and give him 3 minutes to make his public comment over. It seemed liked maybe a technical difficulty caused him to get lost off the line.
Phone Operator: And Mr. Sweeney, your line is open.
Gary Sweeney: Thank you for allowing me to continue. Experiencing life with a child who continues to suffer 10 years past diagnosis, I find myself with many pertinent and important questions like diagnosis treatment and basic biology of spirochetes that I want to present to the group at this time. Why are victims and their families told that Lyme does not exist in non-endemic areas? Are black-legged ticks the only vectors for Lyme? What about Lone Star ticks? What methods do spirochetes employ to evade or disrupt the complement system? What are the interactions between spirochetes and toll-like receptors? Is it possible the immune system is severely down regulated to allow viral and other opportunistic infections to thrive? Why do the IDSA and CDC still rely exclusively on imprecise two-tier testing? What were the criteria for selecting which bands and the number of bands needed for positive Western blot? What about band specific for Lyme like the flagellar? If the immune system is compromised, it’s possible for bands not to show, but we currently test for multiple strains of spirochetes, or is that test for only one strain from the northeastern United States? What is the outlook for using PCR testing and testing to identify tick-borne co-infections? Was Dearborn valid and properly vetted by diverse scientific and medical communities? Why are patients routinely limited to only 2 to 4 weeks of antibiotics? How do physicians treat persistent infection without fear of license revocation and professional persecution? Why does the Detweiler study remain the gold standard employed by the IDSA for unlimited treatment recommendations so it be subject to renewed scrutiny? For far too long, victims of Lyme and their families have struggled to find and pay for treatment. For far too long, groups have talked over, around, and against one another presenting their guidelines for treatment and diagnosis of tick-borne disease; meanwhile, victims suffer and the disease spreads. Lyme has emerged as the number one reported vector-borne disease in our country, but flags and funding levels commensurate with this ranking. United efforts to provide information about tick-borne diseases, to provide effective diagnosis and treatment, and to enact preventative measures needs to receive the utmost attention. Victims of tick-borne diseases deserve no less. Thank you.
Rich Wolitski: That ends our public comment period. So, we’ll move on to the next item on the agenda. Thank you everybody for taking time to share your experiences and thoughts with us. We appreciate it.
John Aucott: So the next part of the agenda is our breakout meetings. So there’ll be six simultaneous, mutually exclusive meetings going on. So you should have preregistered for one of the six and only one of the six breakouts. The operators are going to kind of do their magic to make the changes happen, so you’ll be on the right line and the subcommittees will start their meetings at 2:05. So we now will turn it over to the operators to give us instructions.
(Breakout sessions occur and return to the main room - 01:58:27.)
Kristen Honey; Well, welcome back to the main room with hopefully everyone. If folks are having trouble seeing the video and joining the new, the full room with all of us, then that Q&A box can help. And I think we mostly addressed them all, but I’m going to turn it over to John and you want to just run through... Well, it’s pretty simple. We’re just going to have each of the groups do a quick report out and then we’re going to go into more logistics and timelines to make sure everyone moves forward. So John, do you want to facilitate the working group?
John Aucott: So we’ve got six now brief reports, one from each subcommittee with your deliverables in terms of your comments on the inventories, ideas for the next town hall, and then any other brief comments. So Pat and Ben, are you guys ready to report?
Ben Beard: I think so. Pat, are you there?
Ben Beard: All right. Pat, are you there? (Silence.) All right. Well, I can go ahead and speak on her behalf. I think Pat was actually making the list summary of it all, and so I know I’m going to miss something, but I think in terms of the inventory, and Pat, if you get on the line then please just dive in at any time. But I think in terms of the inventory, I remember two comments that were made in particular. One was about being able to capture more information on training as a callout and the other one was it seemed like the inventories that were made available. One was to HHS - so that obviously covers operating divisions there, NIH, FDA, CDC, et cetera - the other one was for DOD. And we just recognized the fact that there are other federal stakeholders that, um, it would be good to inventory; most notably USDA for the range and breadth and history of work that they’ve done on tick-borne disease prevention, and EPA also is very invested in this area, as is the U.S. Geological Survey and several other federal...probably 8 or 10 different federal agencies that have...that work in this space. So, I think that we need to consider how to inventory those other agencies, as well. So, there was training and then there was the other agencies specifically related to the inventory. And Pat, are you on and would you like to comment on that?
Rich Wolitski: She sent me a message. She’s having problems with the phone line. She got cut off and she’s getting reconnected back in. I would like with the other (indistinct - 02:01:31) agencies that made the dec...temporarily made the decision to limit to CDC and DOD as a starting point. I think the question is, you know, as the folks get into the work a little bit more, how much bandwidth do we have to take in the additional information and use it within the 12-week period that we have in front of us?
Ben Beard: Yep, good comment. So other reflections: there was a lot of talk about the list of activities and expanding that, and I think we tend to get down into the weeds a little bit more, but we wanted to make sure that things like vector surveillance was... There was a distinction between that and human surveillance and also the need for more research specifically in the world of vector ecology and how changing vector ecology is having an impact on emerging tick-borne and model tick-borne diseases, which also was a comment under the list of tick-borne diseases that may be, uh, to be a little bit more specific, um, in terms of mentioning emerging and model tick-borne diseases, and there were several other disease agents. Lyme wasn’t really broken out, you know, between burgdorferi and some of the newer agents that have been seen, such as, Borrelia mayonii. And the same way with relapsing fever. And then there were several viral agents that are not called out—heartland virus and bourbon virus, for example. And then the whole issue of Bartonella, whether it’s tick-borne or not, and what is the evidence to support that, not discounting the fact that everyone realizes and recognizes that it’s an important pathogen, but is it tick-borne? Is it flea-borne? Is it exposure to cats and whatever? So, those are some of the research questions. And I see Pat on the screen; so Pat, I will pass it over to you for continued comments on this.
Rich Wolitski: And I think she can hear us, but she can’t be heard by us right now is the situation there.
John Aucott: Why don’t we move on to the next subcommittee. Wendy and Estella are you there, from “pathogenesis?”
Kristen Honey: And just a friendly reminder that we have 5 minutes for each group. So, if you can try to frame your report-outs in about 5 minutes, that would be most helpful. Thank you.
Wendy Adams: This is Wendy. Estella, are you on? (Silence.) Okay. I’ll go ahead and Estella, if she joins, can go ahead and comment, as well. Um, so the first thing on the inventory, we had some questions and clarifications and additions. The first was, we would like to know the agency and offices, how they engage the public and feedback that are really patient specific. We’d like that broken out between research grants and communication; how offices are directly engaging with patients, not just the public at large. For co-infection and tick-borne disease...the section where you can mark off for each tick-borne infection, we wanted to understand if it can be noted where a certain program is studying co-infection in itself. So, are there studies being done on Borrelia and Babesia either in animals or in a test tube, when those pathogens are co-located in a patient or an animal? And specifically addressing the problem of co-infections and how that might change pathogenesis. We wanted to call out acute illness versus chronic illness. So what, you know, government activities are happening in relation to either acute or chronic and what’s the kind of combination, what that looks like. And also, the years covered for financial...what financial support is given, I think, in the current inventory it’s listed from fiscal year 10 to 2016/2017. I think we felt that that was insufficient, that we needed a more historical view and not just 5 or 6 years. And we also were looking for it as a percentage of the overall budget, either by the department or by the group depending on the best way to look at that. So not only is the number per se, but also as a percentage of department expenditures. For the town hall, I think the questions we came up with were, “What are the outcomes patients really want us...want to be studied? What are the endpoints that patients really want looked at?” Because they might be different than what scientists and clinicians may think that patients want to study. So that was one aspect. And then really a discussion about the science rigor and how we introduce or communicate the science rigor that is needed in each one of these areas to come up with good solutions and discussions to the government based on what we have and what we need to have to study it in a rigorous way. And then lots of feedback on what we want to cover, but I might have... Do I have any more time to go through that?
Kristen Honey: Yeah. You have about a minute and a half.
Wendy Adams: Okay. So I think we... You know in our first discussion and we came up with... Certainly, one of the biggest areas that runs through the different areas and also the different academic backgrounds of the people on the subcommittee was persistence of disease and infection both in immuno-competent hosts. So you know certainly in animals like a mouse or some kind of reservoir, how Borrelia persists in that despite an immuno-competent host and then also how Borrelia and other tick-borne disease might persist despite antibiotic treatment and despite what may be either in physician (indistinct - 02:07:46) or what’s thought as physician antibiotic treatment. What are the mechanisms of those and how...what’s the data on that and how do we study that going forward?
John Aucott: Thanks, Wendy. Fantastic. Lise, are you available for “testing and diagnostics?”
Lise Nigrovic: Sure. Can you hear me?
John Aucott: Loud and clear.
Lise Nigrovic: Okay. Great. So for the diagnosis and testing, I had some technical problems, so John got things started and we had 7 out of our 10 working group meeting members in attendance, which was fabulous. In terms of focusing on the inventory, I think some of the points that were brought up by other groups were also sort of raised or discussed in ways as well, but the two points that I wanted to make was our group noticed the absence of specific questions about regulatory efforts, FDA efforts, et cetera, and although those could be captured in “other,” we wanted to be a little bit more specific in that language so that we could capture that effort as well and then just some additional thought around the language around “other tick-borne diseases, flesh conditions,” and a thought about whether we’re being consistent with our overall mission around being as inclusive as possible in capturing this type of work. So I think the team took some notes on how that might be rephrased. We spoke a little bit about the town hall and you know we’re so early in this process, we hadn’t really well-developed all of the questions, but I think the engagement of patients and families with specific questions about their needs would be really helpful in informing our next steps. And so we’re very much in support of the concept, and we probably need a few weeks to get back with specific questions to address. We threw out some great ideas around our main points and know we have worked to do when we next have our meeting and finalize our subcommittee membership, but clearly recognize gaps in current diagnostics that are leading to confusion, the exclusion of special populations, and the need for patient and provider education as areas that we’re going to address in our work. But that’s sort of a summary of where we got started. John, do you have anything to add?
John Aucott: Fantastic. I just would add Steve Schuster mentioned the idea of a glossary of terms so that we would have a consistent language across what we’re discussing and that that might be also an asset to all of the subcommittees to make sure we’re talking about the same things.
Lise Nigrovic: That’s a great idea. Thanks for mentioning that.
John Aucott: Super. All right. Thanks, Lise. Next is the access to care and support to patients. Karen and Scott Cooper.
Scott Cooper: Karen, do you want to go ahead and start off?
Karen Vanderhoof-Forschner: Okay. I’ll start off and Coop will jump in if I misstate or forget stuff. We were also concerned about the historical collection of information where its inventory of tick-borne diseases, number one, and so we also wanted that *** (indistinct - 02:11:09) and tick-borne diseases. There was conversation about how the Western blot was a problem for diagnosis and treatment. It’s not a help and there was concern about the misuse of the surveillance criteria. It used to have a caution on it, but that caution has been dropped by the CDC and that was useful to prevent it from being used for diagnostic and treatment purposes. There was conversation about in focus area 1-A, I mentioned that we should also ask for where the military has dropped tick bombs around the country. As you know, there was experimentation and ticks were released from airplanes around the country in its bio-warfare research activities, and so we want to know what pathogens were inside those ticks and what species of ticks were dropped and where they were dropped. We were interested in medical care and protocols for patients seeking diagnosis and treatment; also from CMS, from Medicare and Medicaid, the Department of Veterans Affairs, and the Bureau of Indian Affairs: I personally know the Passamaquoddy Tribe is having problems in Maine as are some Indian reservations out on the West…Northwest area and we need to have a better understanding of how we can help them and what they are doing. So it would be another area of the government. On the second page where it’s C, it talks about the diseases. I think we need to be very specific to include tick paralysis, Bartonella, Alpha-Gal, and Borrelia hermsii, and the group also would like the other Borrelia miyamotoi, if I’m saying it right, the other strains specifically listed so they’re recognized in this. And in your questions under D, “Which division is responsible for establishing medical or protocols for diagnostic criteria?” That’s about as far as we got, and we will be finishing the other issues over the weekend by emails back and forth so you have everything, but the group is very engaged trying to get as many of these things done as possible and still get to know each other. The town hall we didn’t get to, because we need to do this first and we didn’t get to discussing gaps, blocks...pretty much blocks, but not gaps, and so we’ll be working on that also. We are identifying vulnerable populations that we would like to address, but the group is fully engaged. These are amazing people. I am very lucky to know them and work with them; including Scott Coop!
Scott Cooper: Thanks, Karen. Yes, I think that covers it.
Karen Vanderhoof-Forschner: And I would like the chance to present to them and the other working groups at some point, the presentation of Dennis Perenthiat’s, (spelled phonetically) “Seronegative Lyme disease in 1998.” It’s at a medical conference and he presents out of the largest clinical trial which was a SmithKlineBeecham trial, that 36% of the culture positive patients were seronegative. That’s huge and so I think that would be a useful thing for people to hear directly from the clinical...the doctor clinical director. It’s not about the vaccine, it’s about the patients; that the bull’s-eye rash is not the standard rash. So it gives us a reset button to think about with scientific basis.
John Aucott: Okay. Vaccine and therapeutics. Dennis are you available?
Dennis Dixon: Yes, I am.
John Aucott: Thank you.
Dennis Dixon: Our group has worked through our mission with amicability and efficiency. Rob Smith was not available, because he had a conflict, and we had two subcommittee members who also had conflicts—that was Juan Salazar and Stanley Plotkin. Kindly the other members of the subcommittee made up for lost members and helped to walk through the work plan and we... I think our first slide was to get to know each other. So we all got...had a good conversation on who each other was and our backgrounds. Then we divided up the work process working through, I think, essentially an intense 2 months going through inventories of the existing drugs and vaccines or recently past available ones, and then moving through to the ones that are the subject of activities for the federal government and how we divide this work-up into modules that we can patch together into a report at the end. And we’re coming up with volunteers and suggestions for people to invite to our 1-hour calls stretching over the next 2 months on the areas that are within our focus. And so it was pretty straightforward; a lot of good input and suggestions and no insurmountable barriers. I think it’s clear that Rob and I are going to need to talk with our co-chairs and the “therapy” session to be sure that we are coordinated properly with those who are deploying the treatments versus those of us who are identifying them and be sure that we don’t have any gaps unintentionally across those two related areas.
John Aucott: All right. Thanks very much, Dennis. Next group is “other tick-borne diseases and co-infections,” Richard and Allen. Richard, are you with us?
Allen Richards: This is Al Richards. We were having trouble with Richard’s audio before. So if Richard can hear us, hopefully he will... While he is out, I’ll get started then.
John Aucott: Thanks, Al.
Allen Richards: So in the inventory, a couple of things that we noticed were the list of agents. Some were very specific like Rocky Mountain spotted fever and others were very broad and as was brought up earlier, having either all the agents listed or to maybe put it in just general groups. Like instead of Rocky Mountain spotted fever, just say rickettsial diseases, Babesia diseases, et cetera, and it might be easier and we might get more information back on those inventories. A lot of our time was spent on going through what “other tick-borne diseases” are and what are “co-infections,” and so a lot of discussion about the different ideas of the members of the subcommittee. And so we have interests in...certainly in Lyme co-infections, a very strong interest in that, thinking that that’s probably where a lot of our work will be. Also, diagnosis for other tick-borne diseases and co-infections were brought up; vaccines against ticks, and the pathogens they have. Just knowing all the different tick-borne viruses and tick-borne bacteria and trying to prioritize them and last was Alpha-Gal. We’re not sure where else that would be discussed, but possibly in this particular area. Richard, are you able to get in? (Silence.)
Karen Vanderhoof-Forschner: Can I ask a question?
John Aucott: Okay.
Karen Vanderhoof-Forschner : This is Karen Vanderhoof-Forschner. I know you’re interested in lumping rickettsial diseases without having to name them, but I would prefer for access to information and open science that the rickettsial diseases then be put in parentheses afterwards, and it might be a burden on typing, but it’s clarity of information, making it more accessible to the public and everyone, as well as an educational opportunity. So, I’d like to see things sort of spelled out clearly.
Allen Richards: Well, Karen, I like that idea myself, as well. I’d like to see more specifics, but it was just sort of patchwork, some things were specific and some were not. So either we have to list all the different diseases or we make generalizations. So I like your idea...
Karen Vanderhoof-Forschner: Let’s list everything.
Allen Richards: Yes. Okay.
Karen Vanderhoof-Forschner: And we had a comment about co-infections in our group that some of the docs are seeing—not Lyme and another disease—where the other disease is traditionally called co-infection. They’re just seeing Babesia or they’re just seeing Rick... (indistinct - 02:21:09) ...in patients and that is not a co-infection. That is the infection, so there is...
Allen Richards: Yes, so we have... Sorry, Karen. Yes, we have both. We have other tick-borne diseases, so that would just include individual tick-borne diseases, whether it’s rickettsia or babesia, but also co-infections with...
Karen Vanderhoof-Forschner: Right.
Allen Richards: Yes. So we see that that we’re responsible for both those situations.
Karen Vanderhoof-Forschner: Very good.
John Aucott: Thanks so much, Allen. Anything else to report back?
Allen Richards: I just... I can see Rich. He’s very frustrated because he cannot speak.
John Aucott: All right. Yes. Okay. Our apologies. I think we’re going to go and close up the reporting back session and move into the last session, which is, “Where do we go from here?” And let me just start by saying, thank you to everyone. It’s incredible to get everyone together. We realize it’s a short notice, but people really did a Herculean effort to join us and I think everyone agrees, it’s an amazing group of people. I can’t imagine a more talented and diverse group of people. So thank you very much. So where do we go from here? I mean now it’s time for the heavy lifting. The subcommittee groups will start to meet in the next week or two and develop their schedule of regular meetings, and we thought we’d like also give you kind of a broader overview of what the timeline is over the rest of this calendar year. Rich, are you able to put that up?
Rich Wolitski: I think so. I think I can go ahead and share my screen. I hope I haven’t been already. It didn’t look like it was, but it starts appearing... Hit control. Okay. Share my screen.
John Aucott: What Rich is going to show you is that, as you all know, we’re on a tight timeline and that you know our report, you know, goes out in June, but then things happen and are involved in the reviewing of that. So that accounts for why we have to get our report in in a reasonable time. So Rich, if you don’t mind, could you kind of walk us through this?
Rich Wolitski: Yes. We just were sort of using this as a background document to kind of help sort some things out over the last couple of days, and so we’ll put this together in a slightly more cleaned up format and send it out for everybody to look at. But this kind of was our exercise to step back and say, “Now that we’re here and we’re able to look at the work in a more focused, concrete way, how do we break it out to make it all happen so that we can get a report to Congress by December 13?” And so if we start here and we work all the way back, you can see there’s a lot of stuff that needs to be done, and so let’s focus more on the near-term. We’ve got our subcommittee meeting started today. We’re thinking that, and basically you look at the calendar, if you count this week, there’s 13 weeks until the report to the working group will be due from the subcommittees. So it seems like you may want to schedule meetings for every week. Get a set time and then if that week you don’t need the time, then you can just cancel that meeting and not use it, but it’s probably going to take pretty much close to a weekly meeting for folks to really get the work done or a lot of homework assignments for people to really do a lot of writing and work ahead of time, but if you do that, you gotta be sure that people are on point and they have the same vision that we have for getting the work accomplished. The inventory: so we will welcome any comments that people have in writing over the next couple of days. What we’ll do on our end is try to pull together a revised listing of the pathogens and the rest of the co-infection issue, send it around to everybody, and you’ll be welcome to add to it, change it. I think we’ll do kind of a conceptual category that captures the class pathogens and then name out the individual ones under it and then we can take it from there. And anything that people raise as comments with the inventory that maybe concerned to be a huge amount of work, can...like it was relatively minor, the one thing for folks to consider is that if we do want to go broader than HHS and DOD, um, that covers the two groups that are formally recognized on the working group. It’s a smaller bite to take for getting a report done in 13 weeks. So, I will say when I think about stuff coming back, if you look at the timeline, you know if we get it out through Exec. Sec. on the 23, they’re going to need to have about a month to get it back to us, and that’s just to get it back to us in a month. They don’t always send things back on time and it can be a pain, particularly getting this type of information back from folks.
Kristen Honey: From a few different angles, we’ve heard the recommendation that we should also consider pulling from VA, because they have one of the largest data sets and all that, and they internally did that like a year or so ago and it’s hard. I mean coding isn’t done, but that transition from DOD to VA, its opportunity and it could be at least putting a framework up of like what would be nice to have.
Rich Wolitski: I guess so that’s kind of a question, really a broad question for the group......is do people think going a little more narrow and getting the experience and getting this inventory right, um, in the first go-round is better starting smaller? Or do you want to go for all of it? And we can do that, but then it’s going to mean more stuff coming back to us to manage and more stuff coming back to you to make sense of, and I think, at this point, you know, we’re interested in some overall statements about how much is being spent, what’s being done, what’s being spent, and then we’ll have the ability to produce an appendix, but it will have a little summary of each project that’s identified that’s specific to tick-borne disease or co-infection that occurs with a tick-borne disease. So that’s really I think a question for the group, um, to ask. I mean, how many people... I mean who is in favor of... Who thinks it’s critical that we go broad right now, which would be a different approach than what we’re doing at this time?
Kristen Honey: This is Kristen, again. I don’t think we should go broad with everything, but I think if we’re doing DOD it would be really prudent to engage VA, especially at this point under this administration, because there’s such a huge push for veterans’ care and a real shift in health care where it’s doing more patient-centered, user-centered. If you think of all the people who are active military and service members transitioning to VA, that’s a huge population. So that’s my plug. We don’t have to boil the ocean, but maybe we do HHS, DOD, and VA.
Rich Wolitski: Any other thoughts? So, motion on the table to add the VA. (Silence.) Anybody else?
Kristen Honey: Anyone want to second it?
Wendy Adams: This is Wendy. I second it.
Rich Wolitski: Okay. So I think what’s... Let’s just do a...try to do a voice vote and see, if all in favor?
Multiple Working Group members: Aye.
Rich Wolitski: Opposed? Anybody opposed? (Silence.) Hearing no opposition, the motion is carried unanimously. We’ll go forward and add the VA to that. So this is kind of the rough timelines here for that and quite frankly, it’s going to take a bit of a lift to figure out how to manage this month. And I think if there are any ideas that people have when you look at the inventory, for things you think we may not need this time around, cross things out. I’ve heard people adding things, but so far I haven’t seen anything going away, which is how it always goes. So I’m thinking about the national town hall meeting occurring ideally before we reach the halfway point in doing the subcommittee work. I think it would be too bad to miss the opportunity to inform the work that you’re doing earlier, rather than later in the process. So that’s something that we can reach out to people about dates and times. It would also be virtual. Um, we may reconsider... We’re still not going to do multiple breakouts with that. We’ll do one call at most and probably we’ll do a lot of it just over audio. The one question that I have to look at is I think if all or most of the working group members are going to attend, then it may have to become our public meeting number four, and so we’ll probably manage to do that, which is not a big deal. It’s not a big deal to do for that to take place. Um, and what we’ll do with that is we’ll have some time to get the questions and things together, but I think we’ll start working on a Federal Register notice for that this week to send around to people. Um, so now, subcommittee reports for the working group. So, we talked about some of these milestones, but even didn’t get to see the full underlying set of activities and deadlines. So here’s what we’re thinking; if our goal is to get a report back before the next meeting, which–and here’s the big news–it looks like May 10 is the date that works for most of the people, and so that’s the date that we’ll be sending a notice out to you all regarding the virtual meeting as well, um, and it will be one where the focus will be on the subcommittees reporting out to the working group members. And so this will be the first time that folks get exposed to all the information. It will then be followed the next week, May 14, but by what we hope will be a 2-day, in-person meeting where the working group members will get together. They’ll bring back the information that came from the subcommittees, and we’ll start working through, “What does the working group think is important to say about all of this? And how do you want to say it?” and kind of... Basically, it’s going to be start writing and making decisions as a group following the subcommittee work. Um, so we’ll be sending out an email about that as well. So look at dates and all that. But right now, it looks like the 15 was a day that was pretty good for most people, and so we’ll probably try to build in on either side of that.
John Aucott: So are the subcommittee members involved in either of those two working group meetings?
Rich Wolitski: So the subcommittee members can be involved in the presentations of the working group, but they...and they can be in the audience for the full working group meeting the following week, but they have...unless we invite them to be presenters, then they are just like an audience member and the rules only allow for audience members to interact with the working group during the public comment period. So otherwise, they’re just seen but not heard. So looking at the deadlines, we thought this would be good for everybody to break this into some steps. So right now, the first deliverable that we’re imagining is that, with your group, you’ll build on what you started today of identifying what the issues or questions are. These are vaguely termed, but these are things that you think are the most important to think about or do in the area that you’ve been assigned to your subcommittee. They can be... And then when the other tick-borne disease is disease-specific was the way this started; it could be done that way or it could be done by really what we need is improved pract... We need adherence to practice guidelines or we need clear treatment recommendations or we need better diagnostics. You can define the question how you want to. I know we’ve had this large list that we think will come out first. Then we want you to think about, of those, “Which is most important to your group that you think will have the greatest impact in the near-term that needs to be done as part of the work-up to do in your group?” So, just more research and description of those opportunities and priorities. Background section would be the next thing due. And then a method section for describing how your subcommittee went about collecting evidence and what the processes were that you used. and then kinda for the first priority would be March 23. That’s where we really would kinda see how you’re looking at writing up and describing the biggest problems, the biggest issues, or biggest opportunities that you see. And then the outline; it breaks up some of the components that we’d like you to address under those. We’ll probably need to have calls with subcommittees to talk about what we’re hoping to get so that we get something closer to the mark, rather than further away. And I do know we haven’t provided very much guidance to you all and haven’t had a chance to interact with you about this thus far. So we want to do that. So May 10—report back meeting, the week of the 14—rolling up our sleeves and doing writing and decision-making as a working group, and then that leaves us with basically 3 weeks to draft the full report from that period of time. And I think with some of this, we may also be able to break off some pieces and start some work earlier that’s not all done; like a background section for the whole report could be done pretty much at any point in time and then modified to match the information that’s in the particular sections. So 3 weeks draft, then back out to us to look at, to comment on, to revise, and with a goal of having the draft report recommendations fully finalized by the 21st, quick rendered review, and then it goes out to the public and agencies July 20. So we’d have two rounds of kind of complete review and revision within the working group before it went out for public comment, and I think what we’re going to have to do as well, I mean, to be at least some HHS review before it can go out and possibly even CDC and it’s going to be DOD and VA for the inventory; so we’ll probably have to read by those divisions, as well. So the more we talk about a specific agency, the more investment they have in the report and the more rights they have to review and comment.
Kristen Honey: And just so people from outside federal government know, this is an incredibly ambitious schedule. .
Like really, really, really fast. So, what that means is that every single subcommittee is going to have to work so tightly with the co-chair who is in the federal side, and then we have to coordinate across with the federal folks so that we can be sure that what we’re saying can get...like basically can be aligned with like everything else, because otherwise, we’ll just get jammed.
Rich Wolitski: Yeah and the only way... The only place we can control this process is on our end of producing the report. There’s no way that we can speed up the clearance process, unfortunately.
Kristen Honey: Right. We can’t do that at all, but we can kind of talk to our collaborators in these federal agencies and figure out what language might work and do all that and say the same thing in terms that everyone will agree to.
Rich Wolitski: So the public comment in July, probably put it out for 2 weeks for general public agencies to get a chance to start their review at this point in time; revision within the working group; one more round of review; and then we have to go back for the formal clearance within the agencies as well; and then kind of get this a little bit of time for final desktop publishing and five-way compliance, which will be posted; getting us to December. So that’s kind of a... So these are the steps. It really is a lot of work. We’ll kind of... I’ll put this together in a cleaner way and send it out to folks tomorrow, but it’s ambitious and the key thing is, Kristen’s been around clearance and coordination with federal partners. It could be as you write and as you have questions, coordination with the chair, the vice chair, DFO. So we’re all kind of working with the same vision in mind and that there’s less redirecting and retaking apart and putting back together again when drafts come in.
Kristen Honey: Yeah and please, please, please make good use of the chair, vice chair, and the HHS team, because we can from here run some of those back channels for you and that’s how these clearance documents can get through so quickly and so don’t hesitate to reach out to us and we will do everything we can.
Rich Wolitski: And we’ll also work with Jennifer at Kauffman to make sure that the writers have a good sense of what we’re looking for as well, because that’ll be key.
Kristen Honey: Yes.
Unknown: I have a quick question. I missed the one part. You’re thinking about an in-person meeting in where we were before on the 14th and/or 15th?
Rich Wolitski: That week. So we’ll be sending out a...
Unknown: That week. Okay.
Rich Wolitski: We’ll be asking you about dates that week. Correct. And I would say this is something that, you know, if one or two people can’t make it in-person, we can make arraignments to have a couple of people join virtually and do primarily an in-person meeting, but the thinking is that this is really where we’re going to have to start making the harder decisions about what do we think should be included, what do we think maybe goes into the next report, and how do we say these things? And so this is really... Person-to-person will be better to help resolve any kind of apparent disagreements or...and really to have that creative energy when you’re with somebody that you can kind of say, “Oh wait, I think this. Oh let’s do this.” It doesn’t happen the same way virtually.
Karen Vanderhoof-Forschner: And this is a question for Kristen. What kind of evidence is it that when we talk about the plight of the patients and the doctors, what kind of evidence would be considered evidence to you; other than big data or... And I don’t think there’s any medical article that talks about the plight of the patients, other than taking on the issue...which you know we’re interested in suicide, and getting published articles about that.
Kristen Honey: Karen, I’m more than happy to have a longer conversation.
Karen Vanderhoof-Forschner: Patients’ evidence?
Kristen Honey: Yes. So I think evidence is defined very broadly. Data is defined very, very broadly, and let’s put a pin in that and then have a conversation off-line, because...
Karen Vanderhoof-Forschner: I agree.
Pat Smith: And this is Pat. I have a question. I have a question concerning the fact that we’re going to have these meetings, I would like to see a reevaluation of this system, because at least Richard and I, we were both thrown off before we were able to do our report. My phone was actually commandeered. I could not physically do anything with that phone. It wouldn’t let me, but my point being is other people also had a lot of audio trouble, more than I think visual trouble. If we’re going to be doing these meetings and we have to do this audio-wise, then I think someone has to look at whether this system is working for this, because it’s very frustrating to be sitting here doing all the work in the subcommittee and then coming on and not being able to make a report, which I was characterizing, though Ben did a very good job and I thank him for that.
Rich Wolitski: Yes. We hear that. And honestly, things have... You know Adobe Connect is a system that is used a ton and it works, but I think we have some glitches in terms of the instructions and I’ll say for myself, when I went into the Other Disease subgroup, I didn’t pay attention to the instructions, and I got online on the computer rather than calling in to the operator, and I could not be heard on that call and that was my bad because I didn’t pay attention. So we’re going to have a debrief about the system and how it worked and did not work, and we’ll also have a debrief about leading up to the meeting, how we did, and what we need to do better, because I will say that we did not get you materials in a timely manner and I will highlight this one thing on this timeline now, and Jennifer is going to be so happy about it, because we’re asking her to load slides this morning for certain things. We’re going to require that anything that’s going to be presented at the May 10 meeting be submitted no later than May 4 and that’s going to be slides, anything, so that we can get them out to you so you can read them, review them, and think about them before you get to the meeting, and we’re going to seriously enforce that, and I’m the worst abscess that it’s going to happen.
Kristen Honey: And Pat, thank you so much for that feedback. Yes, there’s been a lot of frustrations all around and so if people have feedback, don’t hesitate to email it to us, the whole group, and we will iterate, but internally, we’ve kind of laughed and been like, “We’re not doing this again.” So, so sorry for your experience remotely, but in here at headquarters it also has had quite a few glitches.
Rich Wolitski: And we were counseled against doing...trying to do the breakouts on this, but I insisted that we try, and I think part of it is the breakouts were logistically more of a challenge than I thought they would be, but we’ve learned that. And so I think for one webinar, we may end up seeing if this works a little better or we may go to another system that we have access to, as well.
Pat Smith: Thank you.
Dennis Dixon: A quick clarification on who is doing the Doodle Poll scheduling for the subcommittees. Do the subcommittees do that or is there going to be a centralized process for the next call as we start to schedule?
Rich Wolitski: Yeah, and so Jennifer and the team at Communicate Health and Kauffman will be able to be a liaison for you. So I believe the writer is going to be the person that will be the point of contact, but we’ll send out something in email about how to do that, and you know we’ve been going through the meeting, making little notes about, “Okay, we need to address how to do literature reviews. We need to address how to do this and do that.” And so, we’ll start building kind of a little, I don’t know, manual to running the subcommittees and the ways to get assistance.
I have to say, too, from getting to this meeting, one of the things that became crystal clear is that we need to do a better job differentiating among ourselves here who does what and that’s between the chair, the vice chair, the DFO, the alternate DFO, and the rest of the agency staff, and also Jennifer and her team so that when people have an issue or a question, it can be directed to the right person. Everybody else can be copied, that’s fine, but we’ve kind of had a little bit of a situation where emails would come, and we found there wasn’t a response, they’d jump in respond, and maybe they weren’t the best person to respond, and things got garbled and muddled because of that, and we’re also going to talk about reasonable expectations for responses. I know that, with the meetings, there’s a lot of stuff people needed to be prepared, but we’re just not able to keep up with the volume of stuff that’s coming in on a day-to-day basis.
Kristen Honey: So, we’ll take an issue on this end to synthesize all that and clarify the roles of the HHS team, the support contractors, the chair, the vice chair, and put it all in writing. So, the ball is in this court, um, and then hopefully if there is confusion or you need clarification after, you’ll know who to direct the questions to.
Karen Vanderhoof-Forschner: The other thing I want to say is, I know some of Kauffman’s online is our group doesn’t need the Doodle Poll. We already have the timeframe. It’s Wednesday, 2 to 4, with a hard stop at 4 and that’s a good time for all of us.
Rich Wolitski: And I think this is a good example of how we do a regular system for everything. It makes it easier for people. So rather than keeping track of that on a piece of paper right now, we’re just going to go out and send the email out and when you get the email, all you have to do is say, “We’ve picked this time. Here it is.” And then it will go through whatever that channel is for that communication.
Karen Vanderhoof-Forschner: I like it. Thank you.
Pat Smith: This is Pat. I would just ask, is there any way to clarify to the public when they are submitting things, that again, and I know some people understand, some don’t, about where they need to submit their comments to. That they don’t need to submit it directly to our working group per se, but there’s an address that they should submit it to, and I know it’s been online, but maybe it needs some clarification.
Rich Wolitski: So we’ve tried to clarify it from time to time with various people in the community and some people just want to know that everybody in the world is getting it directly. So, what I would ask of you as well is we try at our end to do it—but sometimes we just get tired and we don’t—is if you get an email from a member of the public saying, “Pat Smith, you need to do blah, blah, blah as part of the working group.” Just say, “I’m sorry. Requests or information regarding the working group need to be directed to the tick-borne disease working group’s mailbox. I can’t respond to them from here.” And just send them that way, and then they’ll come through the channels there. But if we keep on taking them and acting on them, then they... People won’t change their behavior, and we’re going to do a big look at the process for that mailbox starting tomorrow by sitting down and reevaluating our protocol and how that’s working. Quite frankly, you know, we’ve been overwhelmed and it hasn’t always been kept up as well as it could have been, but we’re going to have a system. We’re going to have a daily report internally to this office and a weekly report back out to you all that will kind of summarize what’s come in, and it will give you a sense of what the topics are that people are raising. We can also make the direct text of the emails and things that come in available to you, but that may be a little bit more than people want, but we’ll kind of... We’ll come back with a proposal for folks to consider and get that going this week, and I’m committed to that working, so.
Karen Vanderhoof-Forschner: Well, has anybody been sent material, because I’ve not received anything from you of the public comments going there?
Rich Wolitski: Yeah. Not yet, Karen. So the first thing you’re going to get is a set of public comments that came specific to this meeting, and so we’re going to put those together in one packet and get those out to you this week. You can see those, and then from there we’ll start a regular system.
Karen Vanderhoof-Forschner: And I’d like to see... My group would like to see everything. So, I know some place it says, “Which group does this apply to?” We’d like to see everything. We’d like to just be informed”.
Rich Wolitski: Okay, because I’ll tell you it’s like 700 emails, and they’re long.
Karen Vanderhoof-Forschner: That’s okay.
Rich Wolitski: Okay. I know, but it’s sort of...
Karen Vanderhoof-Forschner: If people take time to send it, we’re going to listen.
Rich Wolitski: All right. Now I applaud that. I tell you, there are not humanly enough hours in the day, um, to do all of it, personally, and I’ll just say that. At some point, it really does become impossible, and you have to kinda think about, “What’s the right balance between respecting the needs and the perspectives of the individual and getting the work done to the benefit of everybody?” And so that’s kind of the challenge we’re facing, but I will watch you superwoman, and I will learn, and we look forward to great things coming out of your group.
Karen Vanderhoof-Forschner: Thank you.
John Aucott: Great. I think we’re going to wrap things up now. I want to thank the HHS staff who did incredible work. Thank you all very much. It’s been a busy last few days, so thanks to the group here; of course, Jim and Rich, and Kristen, and I just appreciate all the expert help, and we’ve framed this as a Herculean effort, but I’ve never seen so much energy and expertise in one place in my life, so I’m the eternal optimist, we’ll get it done. So, this is...
Rich Wolitski: We will.
John Aucott: This is going to happen and so you shouldn’t fret. I’ve never seen so much energy and expertise in one place in my life; so it’s going to get done and we appreciate everyone; the new subcommittee members, thanks, and we’ll get to work.
Rich Wolitski: Okay. Well, we’re done anyway. So let’s say goodbye to everybody. That’s a good note to end on.