Note: Below are transcripts from the breakout sessions of the six subcommittees of the Working Group. These sessions were also open to the public. In addition, there were technical difficulties that made some of the discussions challenging.
Breakout Session 1
Disease, Vectors, Surveillance, and Prevention Subcommittee
[00:00:15] Operator: And welcome to the breakout session topic, “Disease, Vectors, Surveillance, and Prevention.” As a reminder, subcommittee members please press star six to mute and un-mute your lines. I will now turn the conference over to Pat Smith and Ben Beard. Go ahead.
[00:00:34] Ben Beard: Hello, Pat. Are you there yet?
[00:00:37] Pat Smith: Yep. I’m here. Sorry. I had to get un-muted. Okay. We’d like to welcome you to our subcommittee meeting today and we certainly, Ben and I, want to thank you for agreeing to serve on our committee. And at this time -- because we have a very ambitious agenda -- we are going to just quickly introduce ourselves very briefly if we can, and I will call your name and ask you then to give your brief introduction. I’ll start with myself, Pat Smith. I’m President of the Lyme Disease Association. Uh, prevention, research, and patient support is our mission and I also... I’m on the Congressionally Directed Medical Research Program at a panel. And additionally, I work with Columbia University on their advisory committee to their research center. Also, two of my children in the ’80s developed Lyme disease and I have been involved now for 34 years. And Ben, would you go next, please.
[00:01:54] Ben Beard: Thanks, Pat. This is Ben Beard. I’m Deputy Director of CDC’s Division of Vector-Borne Diseases and you know, I’ve been here at CDC for approximately 28 years. And before that, I had worked previously in the area of vector-borne diseases, both nationally and internationally. Thank you.
[00:02:19] Pat Smith: Jill.
[00:02:23] Jill Auerbach: Hello, my name is Jill Auerbach and I originally had Lyme disease undiagnosed for about a decade. And finally in the early ’90s, um, leave my job as assistance programmer at IBM because I was so sick. And within a year I really thought that my life was over. And finally, somebody turned me to a physician that could help and indeed I did have Lyme disease and I had that validated down at Stony Brook, because I’m one of those people that says like Missouri, “Show me.” So, finding that, I was like delighted. I thought, “Two aspirins and I’ll be better in the morning.” So, it was a big surprise to find out that wasn’t the case, and that’s when I dug in. So, the first association I have is with Hudson Valley Lyme Disease Association, of which I’m chairperson; um, then with the Dutchess County Legislative Tick Force, of which I’m a member; Stop Ticks On People, which I’m a board member’ Federal Coalition on Lyme and Tick-Borne Diseases, New York State Coalition, New York State Senator Serino’s advisory board, I’m a co-chair; and started Tick Research to Eliminate Diseases. I’m a coordinator of the scientific coalition and also, not to say the least, but Public Integrative Test Management Workgroup. So, I’ve been buried in this, and I strongly believe that we’ve got to do something about preventing disease. We’ve got to protect our future generations. Thank you.
[00:04:00] Pat Smith: Okay, Jill. Neeta.
[00:04:04] Neeta Connally: So this is Neeta Connally. I’m a professor of biology at Western Connecticut State University. My educational background is in medical entomology and also in public health. So, the work that I do here at Western is specifically related to research surrounding prevention and vector ecology as it relates to the prevention of Lyme disease and other tick-associated illnesses, those specifically associated with the black-legged tick in the Northeastern United States. And most of the studies that we work on are focused in the peri-domestic or backyard environment. Thank you.
[00:04:46] Pat Smith: Thank you. Katherine.
[00:04:48] Katherine Feldman: Yeah, hi. Thank you, Pat. Um, Katherine Feldman. I am a senior epidemiologist at the MITRE Corporation, which is a corporation that runs, uh, federally funded research and development centers to help federal agencies think through problems. But that’s really new to me. I’ve only been here a month or two. Um, prior to that I was at Maryland Department of Health for over 10 years, and prior to that, um, spent a few years with the CDC and with the California Department of Health. Um, at the Maryland Department of Health I was the Chief of the Center for the Zoonotic and Vector-Borne Diseases, and in that role was responsible for vector-borne disease surveillance and investigation. I also had the privilege of being the part of the TickNET, um, program with CDC and other state health departments. So, I’ve been involved in both bread-and-butter public health surveillance of tick-borne diseases, as well as participating in applied research for tick-borne diseases. I’m a veterinarian by training, and also have degrees in epidemiology with a master of public health and other certifications in epidemiology, and I’m delighted to be part of this subcommittee and part of the federal effort.
[00:06:05] Pat Smith: Thank you. Tom.
[00:06:07] Thomas Mather: I’m Tom Mather. I’m a PhD and professor of public health entomology at the University of Rhode Island. I’ve been involved in black-legged tick research, ecology, and control since 1983, and I currently serve as the director of the URI Center for Vector-Borne Disease and its TickEncounter Resource Center.
[00:06:33] Pat Smith: Thank you. Phyllis. (Silence.) Is Phyllis Mervine here?
[00:06:38] Phyllis Mervine: Yeah. Hi. I was on mute. Uh, my name is Phyllis Mervine, and I’m the founder and president of the patient advocacy nonprofit LymeDisease.org. Um, I was infected with Lyme in northern California in 1977. I was finally diagnosed and treated in 1987. So, I thought my life was over, too, but it wasn’t. Luckily I met a doctor who treated me long-term and I got better, but it took a long time. And I am currently, um, Editor in Chief of the Lyme Times, which is now a digital, but for many years was a paper magazine that went out across the country and I’ve worked a lot with epidemiology -- no, I’m sorry -- entomologist Bob Lane from UC Berkeley, who’s done a lot of tick studies in my area, and so I’ve learned a lot from him. And I’m happy to be on this committee, and I don’t know what else to say, but if you have any questions, I’ll take them.
[00:07:49] Pat Smith: Thank you. Robin.
[00:07:53] Robin Nadolny: Hi everybody. My name is Robin Nadolny, and I work for the Tick-Borne Disease Laboratory at the Army Public Health Center, where I’m the program coordinator of the Tick-Borne Disease Lab. I’ve been working in this position for almost 2 years, and I took over from Ellen Stromdahl, who many of you will know, uh, who ran this program for the last 20-some-odd years before me. We run the DOD Human Tick Test Kit Program, where we basically have a passive surveillance program. Anybody that’s affiliated with the Department of Defense that gets a tick bite can submit that tick to us for identification and testing, and they use that information that we provide as actionable evidence when they go to their physicians and try to determine what to do about a tick bite. Um, we also use that information for surveillance, and we have a lot of information from a lot of installations throughout the United States, going back 20-plus years just seeing where...what the distributions of ticks and tick-borne pathogens are throughout the United States. I’ve been working in the arena of ticks and tick-borne diseases for about eight years now. I started in 2010, working with Dr. Holly Gaff at Old Dominion University, and I worked with her for a number of years before completing my PhD in tick ecology, focusing on the tick range expansions in 2016. And after that, I’ve been here at the Army Public Health Center in Maryland.
[00:09:18] Pat Smith: Thank you very much. Alberto.
[00:09:24] Alberto Pantoja: Hello. Was that Alberto Pantoja?
[00:09:27] Pat Smith: Yes.
[00:09:28] Alberto Pantoja: Ah, thank you. Hello everybody. Excuse me. My name is Alberto Pantoja. I am a veterinarian and an entomologist by training. And currently I serve as Director of the U.S. Department of Agriculture, Agricultural Research Service, Knipling–Bushland U.S. Livestock Insects Research Laboratory. And the laboratory has a rich history of doing research to control or eradicate ticks that are also vectors of diseases that affect normally animal populations, but humans as well. Interesting note here on the history, uh, the U.S. Department of Agriculture in the late 1800s discovered and documented for the first time that ticks were able to carry microbes that cause diseases. So, there’s a rich history of this type of tick control and/or eradication research that translates into technologies that can deal with the diseases themselves. So, we’re very honored to be part of this effort and more recently we have also contributed to diagnostic tests for tick and tick-borne diseases and in particular, to the thing that we are addressing. It’s important to note that the situation has global implications. Of course, we are dealing with Lyme disease here in the U.S. It’s a major pandemic, but ticks and tick-borne diseases are a huge problem around the world. Thank you.
[00:11:04] Pat Smith: Thank you. Daniel.
[00:11:07] Daniel Sonenshine: Hi, this is Dan Sonenshine. Um, I hardly know where to begin. I’ve been actively studying ticks since the late 1950s. I’m a retired professor from Old Dominion University, now a guest researcher at the LMVR, Laboratory for Malaria and Vector Research at the NIAID, NIH, in Rockville, Maryland now, and also the author of the book Biology of Ticks and several other articles on the subject. Thanks.
[00:11:44] Pat Smith: Thank you. Uh, Jean.
[00:11:49] Jean Tsao: I just got in.
[00:11:51] Pat Smith: Perfect timing.
[00:11:55] Jean Tsao: Hello everyone. Okay. I didn’t hear you. So I’m Jean Tsao, um, Michigan State University, Department of Fisheries and Wildlife, and Large Animal Clinical Sciences.
[00:12:07] Pat Smith: Thank you. Uh, Monica.
[00:12:12] Monica White: Hi, I’m Monica White. I’m President and Co-Founder of Colorado Tick-Borne Disease Awareness Association, focused on education, prevention, research, advocacy, including patient support. I’m also a member of the Public Tick IPM Working Group. I am a former wildlife biologist and wildland fire fighter for the U.S. Forest Service. I had to leave my job due to my infection with Lyme disease. And most importantly, I am a mother and wife of family impacted by Lyme.
[00:12:46] Pat Smith: Thank you. Stephen.
[00:12:50] Stephen Wikel: I’m Stephen Wikel. I’m Professor and Chair Emeritus of the Department of Medical Sciences at the School of Medicine at Quinnipiac University. Previously I was Professor of Pathology at The University of Texas Medical Branch and Senior Scientist in Biodefense and Emerging Infectious Diseases, the national laboratory there. I have 45 years of experience working on the immunology and other aspects of the tick-host pathogen interface, and have extensive experience broadly across ticks, tick-borne diseases, particularly in terms of things such as the tick genome, of which I was one of the co-authors of the white paper that was success on finding...funding for the Ixodes scapularis [Genome] Project. Thank you.
[00:13:42] Pat Smith: Thank you. Have I missed anyone on this call? (Silence.) Okay. I’m seeing none. The slides, uh, the purposes of the subcommittees and the purposes to support the working group by providing, assessing, and synthesizing evidence; identifying, assessing, and summarizing the data; identifying the gaps; prevent new cases; improve diagnoses; and improve the care and treatment of people living with tick-borne disease. Now there are some things that we need to say that will not be listed on this slide. Um, the working group will write the report to Congress and the HHS Secretary, but the subcommittees will provide them with most of the...
[00:14:30] Phyllis Mervine: Are we supposed to be seeing a slide?
[00:14:34] Pat Smith: No. I think... I’m sorry. You must not have heard me. This is not on this slide, but they asked us to address this.
[00:14:44] Phyllis Mervine: I don’t have any slides. Okay.
[00:14:48] Jill Auerbach: I don’t either.
[00:14:50] Pat Smith: You don’t have any slides?
[00:14:51] Male: If you’re connected to the web link, you should be seeing a slide if you logged into the webinar itself. I’m seeing one right now that says, “Purpose of Subcommittees” and it’s got four green boxes, which is what Pat is talking through right now.
[00:15:11] Male: Yeah, we see it.
[00:15:11] Pat Smith: Right.
[00:15:12] Male: It’s available on the screen.
[00:15:16] Jill Auerbach: I don’t have that.
[00:15:16] Phyllis Mervine: Yeah. I have a complete blank. So maybe I should click again on the link to join the subcommittee. That’s what I did and I got a blank.
[00:15:26] Pat Smith: I would click a box, Phyllis. Is that you, Phyllis? I would go into the box, the chat box, for help.
[00:15:36] Phyllis Mervine: The chat box?
(Echo sound recurring.)
[00:15:45] Pat Smith: Okay. There’s a chat box on the lower right-hand part of your screen.
[00:15:51] Phyllis Mervine: Yeah, no. I don’t have a chat box. I don’t have anything. It just says, “Check for our troubleshooting page.” There’s a link. I had this problem before, and I communicated back-channel with Jennifer, so, and she...suddenly it came on. So, I don’t know what’s the problem.
[00:16:09] Pat Smith: But this is Phyllis, right?
[00:16:11] Phyllis Mervine: Yeah, Phyllis. Now how many other people are having this problem? Maybe it’s just me and Jill.
[00:16:19] Jill Auerbach: Okay, Phyllis. Phyllis, log out and come back in. I got it by doing that.
[00:16:27] Phyllis Mervine: Okay.
[00:16:28] Katherine Feldman: This is Katherine. Um, I... They just sent out a new email with links to all the subcommittee groups. And so, my first time in I couldn’t get in, but when I clicked on the link that was in the email, it got me in.
[00:16:40] Phyllis Mervine: Okay. Oh, here we go. Okay.
[00:16:54] Pat Smith: Okay, I think we’re going to have to move along while you’re getting...
[00:16:58] Phyllis Mervine: Yeah. Go ahead. Go ahead. I’ll just listen.
[00:17:01] Pat Smith: Okay. So this will... This verbiage will not appear on this slide, but it’s a part of this section of the purpose. The working group will write the report to Congress and the HHS Secretary, but the subcommittees will provide them with most of the information that is used to develop the report. We’ll also highlight a number of opportunities that may inform the recommendations the working group develops. The subcommittee is responsible for completing an overview of the issues, describing and identifying gaps in the federal response that will be presented in writing and verbally to the working group members in May. Interim milestones include lists of potential topics, priorities. Each group will address topics in priority order, focusing in on about five to complete the full in-depth assessment. They will also provide a copy of their full report at that time. Now, this portion was in the discussion this morning if you were on the working group. We will talk about how we do this in a little bit, but we could... This could involve looking at existing systematic reviews; scientific articles published in the peer-reviewed literature; other articles and conference presentations; reports and other documents published by agencies, organizations, and programs; presentations from subject matter experts, patients, family members, and their providers; input from public comment; town hall sessions, as well as the verbal and written remarks; the inventories of HHS and DOD programs and activities -- which of course we did discuss this morning -- um, the process of the report. Subcommittees will work on presentations and reports to the working group for the meeting in May. When a document is ready to move forward, the subcommittee members will be asked to review and vote on the document. The outcomes of votes will be determined by a simple majority. The report and presentation to the working group in May will make this info available to the public in draft format for written public comment. The working group will then use the information we provide to make decisions about what will be included in the report to Congress. Confidentiality: all information presented during a closed meeting should be treated as confidential and, just to clarify this, today’s meeting is an open meeting for the subcommittees. But as we go forward, those are not included under FACA and will...and all likelihood not be, uh, will be subject to confidentiality. Due to the evolution of the report, all the work done in the subcommittees is confidential until it has been released for public comment. Although it is not required for subcommittees, one-page summaries will be produced for the subcommittee meeting showing names of all persons who attended, presenters, and topics discussed. Purpose of this breakout session: we’re here to review the work we’ll be doing together over the next 12 weeks. We’ll review the inventory of HHS and DOD programs and discuss the National Town Hall and touch on next steps. Timeline -- the initial major milestones to get us started: on February 15, we’ll send the final inventory tool to HHS and DOD for completion and, of course, we’ll be discussing that shortly. February 23: develop a set of issues, questions, and priorities. March 9: background section of report to the Tick-Borne Disease Working Group. A full timeline with all major milestones will be provided to the subcommittees of the Tick-Borne Disease Working Group so that final products are produced in time for the meeting in May. And May 4: there’ll be a full report and slides. Inventory: at the end of this breakout session, this subcommittee should be able to provide feedback to the working group about additional information they need to capture in the inventory, and that is the inventory that we’ll be providing to the government. The purpose of the inventory of HHS tick-borne disease projects and activities is to provide a summary of HHS activities related to tick-borne diseases, including what the agencies are doing and spending each year with regard to TBD; epidemiological activities related to the *** (unclear due to background noise- 00:22:03); basic clinical and translational TBD research related to the parthenogenesis prevention, diagnosis, and treatment of TBDs; and gaps in TBD research described above. So, at this point in time, we are looking to see in Category A, of the inventory review, are there any other relevant things that should be included from the perspective of our subcommittee? So, the current listing of categories are prevention, vector control education, basic research, research diagnostic floral, research vaccine, research treatment, research vector control, epidemiology and surveillance, research-human translational research involving human beings, medical care and treatment, testing programs, mental health services, mental health support groups, other supportive services, capacity building and technical assistance, and policy development. So, at this time what I’m going to ask is: before you speak, if you would please identify yourself, and I would ask Ben if he could basically take over the comments that are coming in from this. Okay. Does anyone have any questions?
[00:23:40] Jill Auerbach: I’d love to speak. It’s Jill Auerbach. Um, I’m not quite certain where beneficial animals would come in there, uh, you know natural ones in nature, such as opossums, wolf spiders, red fox versus coyotes, etc. And of course, the vector control, I guess, would cover the mice, chipmunks, shrews, deer, and in California, the squirrels and wood rats, but another thing that I have a key interest in is...and I find it very disturbing that - and the CDC had no choice with this - but I’m just going to talk about, um, the natural nootkatone, which is food-grade to humans. It kills mosquitoes and ticks but not honeybees. It’s currently being used in food and fragrance products. CDC testing demonstrated that the soap wash caused infected ticks to drop off mice, killing 85% of them. No mice were infected. Since most tick pathogens transmit in over 12 hours, a nightly shower or a bath with the nootkatone soap could prevent many, if not most, diseases. Simple, safe, inexpensive, no new habits to establish. It would be used by the public. Compliance would be much better than tick checks and would remove minuscule ticks that we don’t find on ourselves. The CDC has had a patent for 14 years but has not had funding to move it forward. There’s something terribly wrong with this picture when funding and profitability by companies prevent effective preventions coming to market. And I think that as a group, there’s something wrong here, and we must consider how we can rush a stopgap measure for this as a personal care product to the public. So that’s what I have to say.
[00:25:46] Pat Smith: Jill, this is too specific, I think, Jill, at this point. I don’t think we’re going that specific. We’re looking at categories. So, I would ask that we just stick to what additional categories are necessary. We’re not going into the specifics at this point in time and I ask that please keep your comments, you know, on that issue. So, did you have a specific category that needed to be listed in addition to the ones that were here?
[00:26:19] Jill Auerbach: Uh, I’m just trying to think of what that might fit in, but “overlooked research” or “problems with funding.” I don’t know.
[00:26:29] Ben Beard: I think... This is Ben. I think maybe...
[00:26:29] Stephen Wikel: ***.
[00:26:34] Ben Beard: Go ahead, Steve.
[00:26:36] Stephen Wikel: Oh, sorry. I would think one area that we might want to look at is whether, you know, the various agencies, what they’re doing in terms of integrated tick management strategies. Another category that I think might be relevant is what’s actually being put together, and I know that CDC has been the main source and has done a really excellent job. But in terms of educating physicians about the changing patterns of where tick distributions are occurring, as well as things that should have been -- newer diseases -- that are being developed, what kind of information is out there or is being used in those areas?
[00:27:16] Ben Beard: So, maybe I can comment on those. This is Ben, and I would just say with regard to Jill’s comment that I think maybe this category of research and to vet research vector control, that’s on the list here on nopal (?) vector control would give us a chance to address that in our subcommittee And Steve, with regard to your comment, I think that the whole idea of the agency inventory that’s being done should pick up a lot of that. And there was a report, a white paper, on tick-borne disease integrative test management that we published a few years ago. Dan Strickman and I were the editors on that, and there’s an update up till about like 2014, maybe on that, and I think we will build on that as we query and inventory federal agencies and activities, but I agree. All of that is really important information, and I think we’ll get into the granularity of that when we meet as a subcommittee and get into more detail. But those are both really good comments, and I think we’ll have those covered. Over.
[00:28:25] Stephen Wikel: Thank you, Ben.
[00:28:26] Katherine Feldman: This is Katherine.
[00:28:26] Pat Smith: Do you have any other indications of any places that we are missing a category here?
[00:28:34] Katherine Feldman: Yes. So, it’s Katherine. You have epidemiology and surveillance. Those are two different things. So, you might want to separate them out. And then I’d also suggest that surveillance -- I don’t know if it’s just mentioned -- there could be vector surveillance versus surveillance of a human disease. So, I don’t know if those are worth distinguishing so that later on we know what folks are looking at: vector versus human surveillance. And then the other comment I was going to make on the categories is that I... It is not clear to me what research…human translational…research involving human beings…means and so, if I were completing this, um, I would be confused by that.
[00:29:14] Pat Smith: Well, I think that that is really what we’re looking for, ones for our subcommittee, I think, at this moment in time. And so, Ben, I’m not sure that that applies to us in this particular category?
[00:22:31] Ben Beard: Yeah. I would think that... Uh, this is Ben. And I think that probably that this is going to relate more to one of the other, like the vaccines and therapeutics or one of the other committee’s treatment or something like that, more than in ours. But Katherine, just to reiterate your comment, again, we’ll get into this when we get into the granularity of our task, but... Um, and so I don’t want to jump ahead, but Pat and I have kind of broken down our committee into, you know, the disease vectors, surveillance, and prevention. And we thought that maybe the whole thing of human surveillance, we want to keep that apart from vector surveillance, but …. And we have some talks and presentations (to bring people all up to speed) that we’re going to be talking about as we move forward. So, I think that those comments will be gathered, and I think the translational research will probably be more relevant to one of the other subcommittees than to ours.
[00:30:33] Katherine Feldman: Right. My comment was just with the parenthetical involving human beings. If I were, uh, completing this and I was doing a TickNet project that wasn’t on therapeutics or vaccines, but I saw the category, it involved human beings, I would feel compelled to check it. So, just pointing that out after a lot of survey design experience, just... Um, and then at some point -- maybe now is not the time -- but your comment about vector surveillance versus human surveillance, that would be good to clarify to distinguish that this subcommittee is not focused on human surveillance. Um, I would appreciate that clarification at some point. So, thank you.
[00:31:13] Ben Beard: Actually, it will be focused on both. So, I think that there are... In this part of the... When the working group was put together, there were concerns in both of these, and there’s a sense in which, you know, I see these probably as you -- as being two completely different areas, but they did get linked together here. But we will definitely draw the distinction between the two. And surveillance has its own issues, and it will be covered in our group, but it will be covered separately from vector surveillance, if that makes sense.
[00:31:48] Katherine Feldman: Okay. Great. Thank you. Thank you for that clarification.
[00:31:52] Jill Auerbach: I have one suggestion on prevention, that it be split into two parts: personal prevention and landscape or environmental.
[00:32:04] Ben Beard: Thanks, Jill, and I think we’ll probably wait to get into the granularity of all this till a little bit later, but yeah, I certainly agree with your thoughts there.
[00:32:13] Jill Auerbach: And one other question is, where would, as far as Eisen’s recent findings that most people contract Lyme disease on their own property…
[00:32:28] Ben Beard: I think that that’s also covered under this issue of prevention and vector control. It’s covered... What we want to do right now is just make sure these current listings of categories are going to be really, um, they cover all the issues that we’re dealing with. We’re going to get into the granularity of this a great deal as we move forward, if that’s okay with all.
[00:32:50] Phyllis Mervine: Um, this is Phyllis. I have a question. Can I ask a question? Okay, I don’t... I’ve been looking up stuff while we were talking and so I’m not clear that the *** (indistinct - 00:33:02) column really belongs under our subcommittee, but I’m not... I don’t know. To me, that seems a little bit broad. But I wanted to ask Ben about the mapping, the risk mapping, and whether that would, um, be under one of the topics that’s down there referring to papers like Lars Eisen’s high agrologic risk site model, um, and I thought that was a really important study because it showed that people that lived close to any of those high-risk habitats that they modeled on their map were much more likely to contract Lyme disease, including in southern California where it’s not really known to be common.
[00:34:03] Ben Beard: Yeah. Hi, Phyllis. This is Ben. Thanks for that comment. And yes, I think that that’s really important work to the purview of our subcommittee and I would see that fitting under “prevention” and also kind of “vector control education” knowing...and “research vector control;” several of these different categories and so yes. I think that’s a really important area of research to summarize in our group.
[00:34:31] Pat Smith: Yeah and could I just make a clarification. This is Pat. Um, the clarification is all of these categories are not under our group. Okay. These are the categories that are in the inventory review document that’s going to go out to the government, and they’re going to have to check off which of these categories their particular agency or whatever does. So, these are not all ours. What we’re looking for is under the ones that would fit under ours; have we missed any? We have “prevention, vector control,” um, you know things like that. We don’t have necessarily all of these. So, if you see something for our committee that is not addressed in a general category that’s what we’re trying to ascertain, and I know it’s confusing, but this is how they put the slides up. So, thank you.
[00:35:27] Jill Auerbach: So, is there one for, um, for acute funding for tick research?
[00:35:35] Pat Smith: I’m sorry. Repeat that Jill.
[00:35:37] Jill Auerbach: Well, there’s acute funding for tick research, and right now what happens is these talented scientists retire and because there’s no real funding, there’s nobody to replace them. The new scientists, the new graduates go into other fields. So, we have a loss of knowledge. There’s a knowledge base loss and a period of training where somebody who’s leaving a position can train somebody and hand things over. That gets lost. That happened at IBM. So I’m very keen on that.
[00:36:18] Monica White: Hi. This is Monica. I’m sorry. I was just wondering if Jill, that might fit under, like, vector research period.
[00:36:31] Pat Smith: Well, I think that -- and Ben, correct me, if you think it’s something different -- but I think that what’s going to happen here is that we are asking the agencies for information on the resources that they provide and resources would certainly include financial, and the questions that are asked in the document are based also on financial. So, I think that’s already covered.
[00:37:00] Jill Auerbach: Where do you see that, Pat? I don’t see that listed here.
[00:37:03] Pat Smith: Well, that’s on the document, which it was my understanding you got, but maybe you did not. The inventory of HHS tick-borne disease project ***... (indistinct - 00:37:15.)
[00:37:17] Jill Auerbach: You mean the ***? (Indistinct - 00:37:18.)
[00:37:22] Pat Smith: ...provide information on the resources provided by your agency or office that support improvement and stability response. That is on the actual document. This is just the category section of the document that you’re looking at.
[00:37:44] Ben Beard: Yeah and just to be certain... On Section D it says, “Complete information in the table below. Be as descriptive as possible. Total funding may apply. 17 total funding for FY18.” So, it gets into a lot of granularity, numbers of FTEs, numbers of fellows and contractors. You know we’re working on these areas of activities. So, I think that that will come out in the inventory.
[00:38:10] Thomas Mather: Ben and...
[00:38:10] Jill Auerbach: Okay. Thank you.
[00:38:11] Stephen Wikel: Ben and Pat, this is Steve Wikel.
[00:38:13] Thomas Mather: Um, it might be appropriate, though, under the “other” just to include training.
[00:38:20] Pat Smith: I’m sorry. Who’s speaking?
[00:38:22] Thomas Mather: This Tom Mather.
[00:38:23] Pat Smith: Oh, Tom. Thank you. We need that for the person taking the record.
[00:38:27] Thomas Mather: I was just suggesting that maybe to capture all of this in a very clear way from an inventory box kind of thing. If you just put under “training,” because you would be able to know what allocations you’ve made for training, like your new vector biology training centers for instance.
[00:38:47] Pat Smith: Ben, what’s your thought on that?
[00:38:50] Ben Beard: Yeah, I think that that will... I’m sure that will get captured. I’m just trying to see if it falls out anywhere here. There’s one for “capacity building, technical assistance, and other.” So, yeah, we’ll make a point of that to make sure that training gets addressed in here. Thanks, Tom.
[00:39:13] Thomas Mather: Uh huh.
[00:39:14] Daniel Sonenshine: This is Dan...
[00:39:14] Stephen Wikel: Uh, Ben and Pat. This is Steve Wikel. I have a question about where this inventory will go. I noticed that the email this morning, it said, “HHS and DOD.” Will the USDA also be seeing this? I’m thinking about the implications that we’re going to probably be asked about one health-type issue dealing with tick and tick-borne diseases and given the USDA’s research agenda.
[00:39:41] Ben Beard: Yeah. Thanks, Steve. That’s a good question, and I would definitely like to see that go both to USDA and EPA as well and for that matter there’s USGS and several other stakeholders that are doing this type of work, so. But for starters -- and you know this whole effort has been kind of fast and furious, and a lot of it occurred over the weekend, getting all this organized, and I think people were thinking in very broad brush strokes. Obviously, it had to be HHS because of the nature of the bill, “The 21st Century Cures Act” and...
[00:40:18] Stephen Wikel: Absolutely.
[00:40:18] Ben Beard: ...then I think people thought DOD because it was very obvious with the CDMRP program that’s dedicated, you know the Tick-Borne Research Program, but I think it should be expanded and I’m sure Alberto and others can help us with USDA and we’ll have to reach out to the other agencies. So, I agree with that.
[00:40:41] Alberto Pantoja: Yeah. This is Alberto.
[00:40:43] Daniel Sonenshine: Why is... This is Dan.
[00:40:45] Alberto Pantoja: I’m sorry.
[00:40:45] Daniel Sonenshine: Is there an update? Can anybody hear me?
[00:40:49] Alberto Pantoja: Yeah. Dan, go ahead, please.
[00:40:50] Daniel Sonenshine: Yeah, I was just curious if there was a place where there could be tick-borne disease training programs where universities could compete for, especially an inter-institutional type of tick-borne training program, that would train people at the master’s and PhD levels.
[00:41:11] Ben Beard: I think... Yeah, thanks for that comment, Dan, and I think that can be... you know, something that could be recognized as a gap and can be a recommendation to have something more formal like that. You may be aware of the Centers of Excellence Programs that were stood up by CDC. It’s a $50-million program with 10 Centers of Excellence. They are not specifically in tick-borne diseases, but all of the different centers have tick-borne disease efforts, and they have a number of training opportunities that really address public health entomology in general. But if this is seen as a gap, it’s a recommendation that the subcommittee can make in the report.
[00:41:55] Daniel Sonenshine: Yeah, that’s why I bring it up as a gap.
[00:41:58] Alberto Pantoja: Hey, um, this is Alberto. Thank you, Ben and Steve, for your comments before and yeah, certainly we welcome having the USDA there at the table, because as some of you may remember, in 2010 the National Academy of Sciences actually had an exercise of this type on the state of the research on Lyme disease and as many of you will know, I heard from the extraordinary group that we have here together, most of these tick-borne diseases are stenotic. So, I think it was Steve that mentioned the one health aspect that’s crucial to address. And so, with the more that...the USDA will be more than happy to share with you an update on our research portfolio and some of the technologies that we have been innovating recently in this research field. And also, in that regard, and to address the comment made before, uh, maybe... I mean, I don’t know if it is separate from translational research, but to me, it’s an aspect of it is, this aspect of finding innovative ways to enable public/private partnerships because from the... I’m a researcher and most of the time we come to a wall where we keep hitting...where we do a lot of research and it looks really interesting. We may even patent the technology, but then we come to this so-called “valley of death” in the research and development of new technologies where we don’t find a way, because -- for the most part, I think -- and I guess, in this case, speaking for myself, I am a federal research entity. I do not have the authority to be seeking approval or registration of a certain technology of the product to commercialize it, and we have to find private concerns that we can partner with to commercialize the technology and then put it in the hands of the end user. So, for example, with the USDA we have the small business research initiative where private concerns, especially small biotechs or small companies, will compete for resources to enable and commercialize...go through the development process and commercialize technologies, you know. So, I think that that would be an important aspect to consider and then more recently working again with industry, especially the animal health industry. We were able to bring a vaccine...the vaccine technology for the Cattle Fever Tick Eradication Program and believe me, that takes time and a lot of effort, but it can be done. And that’s an example of a public/private partnership and then just to the chairman or chairwoman, as well, what is the product? Because we are supposed to report, right? At the end of our session we need to report back and just a question on what that is, please?
[00:44:58] Pat Smith: Okay. Can I just ask at this time -- I thank you for all those comments -- but we are actually running very short of time and we have deliverables that need to be done and so the kind of input that you have is wonderful. And I think that we certainly -- uh, Ben and I --we’re sure to include the USDA in on this committee, and we will be discussing those issues in the future, but right now we really have to move along. If we don’t have any other categories, we still have another section of this review that we have to go over. So, I would ask, unless there’s somebody that has an absolute distinct category that needs to be included on here, um, I think we’ll have to move along. And I would also ask that due to the nature of this surveillance and how much, you know, dialogue has been spent on that, perhaps we can ask them to put after the word “surveillance” in parens “human and vector,” and that would clarify that for us, but it’s not necessarily a separate category. And other than that, what I think I heard and someone can please correct me here, Ben or someone else, um, that we needed to somewhere put “in training” and we can certainly mention to them about reports to the USDA. I believe those will be covered. I don’t think that they’re necessarily a separate category here. Ben, do you have a quick comment on that before we...
[00:46:41] Ben Beard: No. I’m fine with that. Thanks, Pat.
[00:46:44] Pat Smith: All right.
[00:46:44] Phyllis Mervine: Hey, Pat.
[00:46:46] Pat Smith: Yes. Who is this?
[00:46:47] Phyllis Mervine: Um, this is Phyllis. I put some stuff in the Q&A just for my own... I don’t know if other people can see it too. Just for my own clarification. That little box on my screen that’s down on the right side.
[00:47:02] Pat Smith: Yeah. I don’t know.
[00:47:03] Monica White: I cannot see anything Phyllis. This is Monica.
[00:47:05] Pat Smith: Phyllis, we have to really move along. Do have a category or that you suggest?
[00:47:09] Phyllis Mervine: No. I just made a list, a cleaner list for my own purposes of what actually applied to us from this big list so that I could see if something was missing. So, I have down: prevention, vector control education, basic research, research, vector control, epidemiology, and surveillance training programs, and R&D partnerships with private industry.
[00:47:39] Pat Smith: I like the last...
[00:47:39] Male: I see the comments there, Phyllis. Thank you.
[00:47:45] Pat Smith: Okay. I don’t know where you wrote that. So, I don’t see it.
[00:47:49] Robin Nadolny: Hi, this is Robin, also. I just wanted to jump in real quick before we move along and say an additional category that we could add would be “research tick ecology,” and that would sort of be an umbrella that would capture a lot of what people like Jill were saying about the way ticks interact with various hosts, also the way hosts interact with various diseases in nature, with tick range expansions and tick spread; all that sort of thing might be lumped in there. I could see that also going under a number of other categories. So, it’s up to folks whether they think that’s going to be valuable or not.
[00:48:22] Katherine Feldman: Katherine here. And I would say just “ecology,” which would capture all of that.
[00:48:26] Robin Nadolny: Exactly.
[00:48:29] Phyllis Mervine: I like that.
[00:48:30] Jill Auerbach: Tick and vector ecology.
[00:48:33] Robin Nadolny: Yes, tick as well.
[00:48:34] Katherine Feldman: Well, just ecology. I mean if you want to study white-tailed deer, that might not be ticks, so, but could be relevant to tick-borne disease.
[00:48:42] Robin Nadolny: Yeah, tick ecology, or I don’t know, tick-host vector ecology or ecology.
[00:48:48] Ben Beard: I think...
[00:48:49] Jill Auerbach: You know, much of this has caused a huge environmental problem. So, I really like the...your putting ecology there because that kind of covers it. How do we fix the ecology? What can be done? What’s affecting it? What’s simple? What are some of the things that naturally can prevent and what... We have to get information to people so that they can protect themselves. And some of these things are really just knowledge and simple and the other thing that we have to do is team up with, for instance... Um, I know there’s going to be a suggestion made that mosquito control be linked with tick control. So, are there methodologies that we can use?
[00:49:42] Pat Smith: Jill, excuse me. We’re going to be cut off in five minutes, and we have other deliverables. Ben, are we going to... Can we put in that tick ecology or not?
[00:49:52] Ben Beard: Yeah. This is a really, really general list here, and I think that these are great comments. And I think it’s just unfortunate we’ve not given good instruction on this, but when we get into the meat of the subcommittee, I think all of these things are going to be addressed and we’ll work through this on our next...you know when we have a subcommittee meeting, the next meeting. But let’s move on, or we’re not going to get done at all. So, yeah, Pat, why don’t you take this slide.
[00:50:23] Pat Smith: Yes. Thank you very much. And remember, we only got this information ourselves, actually, in the last few hours. Um, okay. Next slide is the inventory review. So are there categories missing from Section C that are relative to our subcommittee and should be included? Well, I know that there are, and I’m sure that you know. So, if someone wants to go down the list of what’s missing or I can go down a list of what’s missing or... Does anyone...
[00:50:58] Robin Nadolny: This is Robin. Uh, they do have a different category for other tick-borne diseases. So, I mean this covers a lot, you know, a lot of different things in the United States. There’s obviously, you know, more that could be included, but do we need to...do we need to actually have a list of every single tick-borne disease that we’re concerned about or does that “other” category kind of grab it?
[00:51:19] Pat Smith: Yes. But we have to... They want us to specify “other tick-borne diseases specify.” So, I think that we do need to probably specify just to make sure that the tick-borne diseases are not left out. Ben, what’s your thinking on that?
[00:51:37] Ben Beard: Yeah, again, I don’t know if we have to give all the details right now, but we have... You know, there’s things like Heartland virus and Bourbon virus that are missing here or there, the broader range of Lyme Borrelia mayonii, and then the relapsing fever spirochetes. Those are generally listed here, but I think for now, you know, unless someone just has their all-star agent that they want to put on here. Of course, I’m sure a lot of people are thinking Bartonella and I think our report will, you know, will have to address, you know, “What do we currently know about tick-borne transmission of Bartonella? What has been... What in terms of Koch Postulates have been, for vector-borne diseases, have been satisfied?” We don’t need to talk about that now, but I think that we can... That’s something that the report will need to address. What are the state of the science and what needs to be done? So, I don’t know. I think, unless there’s some really burning comments, we should move on.
[00:52:36] Jill Auerbach: Okay. Let’s move on. Yeah, if we need to, AGF is another one.
[00:52:41] Ben Beard: Right.
[00:52:42] Pat Smith: Well, we... We can move on and then when we report, when we go back in and report, I’ll ask, if they want, that we do have other specific diseases for other tick-borne diseases and if they want them there, we will provide those.
[00:52:58] Alberto Pantoja: Hey, this is Alberto. Really quick, could it be emerging and reemerging tick-borne diseases as a big umbrella?
[00:53:04] Pat Smith: Ah. I don’t... I don’t know. What is everyone think about that?
[00:53:09] Stephen Wikel: I think that’s a very important point, because I was just about to comment, there are number of unspecified agents that may emerge as pathogenic in future years such as variesrocketze (sp? - 00:53:20) that are frequently found in Ixodes scapularis and nobody knows what they’re there for, what they do, things of that sort.
[00:53:28] Jill Auerbach: And we’ve got things like *** (indistinct - 00:53:30) fever that haven’t made it to our shores yet, and Garth Ehrlich also found about 50 different pathogens in the deer tick and separately in the lone star tick, but that’s all preliminary. He hasn’t published it yet, and many of those or a number of those were pathogenic to humans. So...
[00:53:52] Phyllis Mervine: So, what we need is stuff to say “emerging.”
[00:53:56] Ben Beard: Yeah.
[00:53:57] Phyllis Mervine: Emerging.
[00:53:58] Alberto Pantoja: And reemerging.
[00:53:59] Ben Beard: Emerging would be good.
[00:54:00] Jill Auerbach: Emerging and reemerging.
[00:54:01] Ben Beard: Emerging and reemerging.
[00:54:03] Jill Auerbach: Saying reemerging, what are you thinking about in specific for reemerging?
[00:54:09] Pat Smith: Okay. I think “emerging and reemerging” is good and we’re going to be cut off any second. So, about section... The next... I’m sorry. We have to move on. Section D: this is the current list of information requested and...on these documents and total funding for FY17, 18 is available, 10 to 16 if available, uh, number of full-time employees, supported with funds; additional full-time employees dedicated to TBD; number of fellows, contractors, or other support staff supported with these funds. Which organizational units in your agency or office have responsibility for TBDs? Which one of these, if any, has primary responsibility for TBDs
-- name of director or chief of primary unit; agency/person of contact for tick-borne disease? Does your agency or office have a strategic plan for addressing TBDs, or are they included in your agency’s strategic plan or other priorities set in documents that guide your work? If yes, include a link to the documents or attach a file. What are the strengths of your agency or offices response to TBDs? What are the future opportunities for improving efficiency, effectiveness, and/or impact of your activities for TBDs? What do you see as the weaknesses of your agency or office’s response to TBDs? What do you see as threats to the future of your agency or office’s response to TBDs? What unmet needs have been identified through your agency or office’s work on TBDs? What educational or training tools, tool kits, products, or resources have been developed by your agency or office for TBDs? For 2017, the sole publications the agency’s staff authored or co-authored about TBDs include surveillance or agency author’s reports; provide links where possible. How does your agency or office engage in public and other stakeholders in planning activities and obtaining feedback on activities? And I think that’s... That’s that list. (Chuckle.)
[00:56:34] Jill Auerbach: Who do they refer to as agency?
[00:56:41] Pat Smith: Go ahead, Ben. Do you want to address that?
[00:56:42] Ben Beard: Yeah. So, Jill, these are the queries that are going out to HHS and DOD and whoever else. So, within HHS, you know we... It’s prob... You know the operating divisions. So, it would be CDC and IHFDA, etc.
[00:56:57] Jill Auerbach: Oh, okay. Thank you.
[00:57:03] Pat Smith: Okay. Is there any other thoughts on this?
[00:57:08] Phyllis Mervine: Can you show the second slide of that list?
[00:57:12] Pat Smith: Yes. It’s on... It’s currently on the second slide right now - 11 through 20. Are you looking for something different?
[00:57:23] Phyllis Mervine: Oh, no. Wait. Sorry. I had a screen shot up. So it was just... Okay. I see it.
[00:57:28] Alberto Pantoja: Hey, guys. This is Alberto. I was never able to access the slides. Could you share them via email? Is that possible, please?
[00:57:34] Pat Smith: Uh, I don’t know that we can. I don’t have a way to do that. They didn’t... Unfortunately, we’ve got limited training as to how this was coming down the pike in a short period of time.
[00:57:47] Alberto Pantoja: Okay. Thank you.
[00:57:47] Monica White: This is Monica and these... All of these listings are on the handouts that were provided in attachments with our information for the meeting, if people want to print them off that way.
[00:57:59] Pat Smith: Thank you. That’s what I thought they had done, but you know...
[00:58:01] Operator: Excuse me. This is the operator. You have two minutes remaining before we join you back to the main call.
[00:58:08] Pat Smith: Okay. Well, we need to... Unfortunately, we are supposed to have some topics, which I think we’re going to have to skip to for the National Town Hall Meeting. We’re supposed to have several topics from our working group -- about one or two questions or issues we’d like to pose at the Town Hall so we can receive input from the community. Do we quickly have some suggestions on those?
(Pause.)
[00:58:46] Jill Auerbach: Other than giving them a list and letting them vote.
[00:58:50] Phyllis Mervine: I have written down just a few things. Um, reservoir ticks, environmental and personal protection, funding, and tick research including genomic research.
[00:59:08] Pat Smith: Okay. Does anyone else have anything?
[00:59:14] Monica White: This is Monica. I was just thinking... You know if we’re asking for input from the community, do... Does the community think we have adequate prevention education in place? Does the community think we have the resources that they need available for whether you’re a member of the public, a patient, a physician? Is that the kind of thing you’re looking for?
[00:59:39] Pat Smith: Uh, yes. I think that’s exactly what we’re looking for and I think that’s... You know these are all good suggestions, because I think especially with the...you know this one and also we might ask them why -- related to what Jill said maybe -- why they’re not using or are they using protection methods and, if not, why? That’s something that...
[01:00:05] Jill Auerbach: Pat, I don’t mean to squelch you, but you know people just don’t do everything all the time, especially when it takes so much effort. It just doesn’t happen, and that’s why we’ve got to provide them with something that works and is easy to do. I think if you speak to people and you say, “How do you feel about being able to protect yourself against ticks?” They’re going to say they don’t feel very confident about it. So, that’s why I have been pushing so hard on... It’s going to take years and years before we get to develop everything, but something simple like a soap to wash themselves with, or I believe Tom said he used... He had at one time had a patent on permethrin in a soap. Well, nootkatone’s a lot safer. I think we have to get away from the fact that there isn’t funding for it right now and away from the fact that the company who now has a license on it may not make enough money from it, but it will help the public immensely. So, do they feel that they have easy protective measures? And you know they’re going to say no.
[01:01:19] Pat Smith: We’ve just gotten... We have less than one minute, and we have to get these recommendations in. So, what we’re looking at right now maybe is, why using or not using protection, adequate prevention, and education. And I also felt that we need to hear what about surveillance and how the current surveillance is impacting access to care for patients?
[01:01:42] Robin Nadolny: I agree. This is Robin. I would also like to add on to that that, “How are they receiving information about tick range expansions and the changing risks?”
[01:01:53] Jill Auerbach: Right.
[01:01:55] Pat Smith: Okay. Are there anything else real quick before we’re shut down? (Chuckle.) Anyone else have anything?
[01:02:02] Jill Auerbach: I have something to complain about is that they throw this at us and don’t give anybody time to look at it ahead of time.
[01:02:10] Pat Smith: Jill, believe me. You’re speaking to the choir here, please, and we need to stay on target. I just want to add, and we may get cut off, that Ben and I have been discussing about how to do these meetings down the road and we were thinking about the possibility -- I don’t know if it will work -- but we were talking about the possibility of Friday. But there’s going to be a Doodle Poll that will be put out, but I think that if there are people who have a commitment every week at a certain date, we would certainly want to know about that and we would try to go away from that. Um, but that’s what we were talking about at this point in time with the idea of maybe -- I don’t know if this will come about -- but maybe we could even get in a meeting late next week so that we could perhaps move forward. I don’t know that that’s going to happen, but does anybody have a particular day that they know that, uh...
[01:03:13] Male: Monday...
[01:03:13] Jill Auerbach: I don’t think they’re good because there are a lot of conferences and things that start on Fri...uh, that you have to be away Thursday, Friday, Saturday, Sunday. I would suggest a Monday would be a better day.
[01:03:25] Pat Smith: Well, we can certainly... You know we can vary it and we don’t have to stick to a specific schedule. We can, you know, maybe do it, you know perhaps... You know, we can book them up in uh, you know, a month or two in advance, but we were trying to get some idea about days that were good for people and so, I don’t know. Does anyone else have any other thoughts?
[01:03:55] Katherine Feldman: Katherine. I actually liked Friday. So, if you’re going to do a Doodle Poll, be sure to include it.
[01:04:00] Pat Smith: Okay. Thank you. We’ll try. (Chuckle.)
[01:04:03] Female: Yeah. Well, Monday. We’re all here today.
[01:04:08] Pat Smith: Yeah. I hear you. Okay. Anyone else have any input on that? Ben, did we cover everything, other than what...
[01:04:16] Operator: And pardon me. We’re now transferring you back to the main conference.
(End of Breakout Session 1 - 1:04:36.)
Breakout Session 2
Pathogenesis, Transmission, and Treatment Subcommittee
[00:00:12] Operator: Welcome to the breakout session topic “Pathogenesis, Transmission, and Treatment.” As a reminder, subcommittee members, please press star six to mute and un-mute your lines. I’ll now turn the conference over to Wendy Adams and Estella Jones. Please go ahead.
[00:00:28] Wendy Adams: Hi. This is Wendy and Estella I’m assuming you’re on? (Silence.) Estella might not be here yet. Estella, are you there? (Silence.) Can you hear me?
[00:00:44] Sam Donta: This is Sam Donta. I can hear you.
[00:00:46] Wendy Adams: Okay. Hi Sam.
[00:00:49] Lorraine Johnson: Hi Wendy.
[00:00:51] Brian Fallon: Brian Fallon is here too.
[00:00:51] Mr. Skare as well.
[00:00:54] Wendy Adams: Okay. Sorry. So, let’s just give it another minute to make sure everybody’s had time to come over and then we’ll do a roll call, okay?
[00:01:05] Sam Donta: Are there any visual components here?
[00:01:09] Wendy Adams: There is a slide presentation. Are you seeing anything on your Adobe Connect?
[00:01:15] Sam Donta: All I’m seeing is the various faces: Pat Smith, Karen’s, Richard’s.
[00:01:22] Wendy Adams: Okay. Did you press the link on the last page of the...because there’s a slide presentation? Did you press the link on the last page of the working group slides that you were on?
[00:01:41] Sam Donta: We didn’t get those slides from the working group.
[00:01:45] Wendy Adams: Okay.
[00:01:47] Jon Skare: I’m seeing the screen for the “tick-borne working group pathogens, transmission, and treatment.” So, it is coming through. This is Jon Skare.
[00:01:53] Wendy Adams: Hi Jon.
[00:01:55] Jon Skare: Hi.
[00:01:55] Wendy Adams: So, Sam, back to you. Did you... So, you never saw the slide. Were you on the Adobe Connect slides for the working group?
[00:02:04] Sam Donta: No.
[00:02:06] Wendy Adams: Okay. Are you in Adobe Connect?
[00:02:08] Sam Donta: I think so.
[00:02:10] Wendy Adams: Okay. Do you have the the...basically the Software up on your screen? Then you see the video, right?
[00:02:19] Sam Donta: I only see the faces of Pat Smith or with Cooper. Those are the videos.
[00:02:27] Wendy Adams: Okay. So, I think if you let me just... I’m going to see if I can... Yeah. So, that means... Can you minimize your video window?
[00:02:40] Sam Donta: Yeah. Okay. Wait a minute. Let me... Okay. Here. I have Stan there as a guest. (Pause.) Uh, it’s, “Joining the audio conference.”
[00:03:11] Wendy Adams: Okay. So, you need to mute...mute yours peakers on your computer so that we don’t get feedback, because I’m assuming you’re on a conference line on a phone, is that correct?
[00:03:23] Sam Donta: Yeah.
[00:03:32] Wendy Adams: Okay. So, are you seeing the software?
[00:03:35] Sam Donta: I’m seeing “tick-borne disease working group pathogenesis transmission...”
[00:03:40] Wendy Adams: Perfect. That’s perfect. Okay, so Estella, let me see if you’re on? Are you on Estella? I don’t see Estella yeah.
[00:03:56] Operator: Excuse me. This is the operator. Her audio line is connected. She’s just not speaking over it.
[00:04:01] Wendy Adams: Okay. I don’t see her as joining the group though. I don’t see her in the participants.
[00:04:14] Sam Donta: What am I supposed to be seeing Wendy? I see this “tick-borne disease working group pathogenesis, transmissions, and treatment” and under video is a blank screen. There’s well...
[00:04:22] Wendy Adams: You don’t need to... Yeah, we’re not going to use video, but you do need to see these slides, because that’s going to take us through the, you know, the hour that we spend in the subcommittee. So, don’t worry about video. Don’t worry about sharing. We’re not going to bother with the video.
[00:04:36] Sam Donta: Okay. So, I’m going to see slides when they’re ready?
[00:04:38] Wendy Adams: You’re going to see slides. These are the slides. This “tick-borne disease working group” and then I will... I have the “com” so to speak, I believe, and should be able to... (Pause.) Let’s see. Okay. Let’s see; I am not able to run through these slides. Oh yes. Here I am. Yep. Never mind. Okay. So, let’s go ahead and take roll and just see if everybody’s here, and I think I have a communicate health person to take notes, is that correct? (Silence.) Okay, I’m going to assume she’s here. Oh, yeah. She is on. Okay. So, let me just take roll and that way then we can get started. Patricia Coyle.
[00:05:49] Pat K. Coyle: Yes, I’m here. Should I mute my phone unless I’m specifically talking?
[00:05:55] Wendy Adams: Uh, that’s fine if you want to.
[00:05:58] Pat K. Coyle: Okay.
[00:05:59] Wendy Adams: Sam Donta.
[00:06:01] Sam Donta: Here.
[00:06:02] Wendy Adams: Brian Fallon.
[00:06:05] Brian Fallon: Here.
[00:06:07] Wendy Adams: Lorraine Johnson.
[00:06:09] Lorraine Johnson: Here.
[00:06:11] Wendy Adams: Elizabeth Maloney. (Silence.) Betty, are you here? (Silence.) Okay. We’ll come back and see if she’s... I know she’s on... I saw her on the call; So she might just not be in the right room yet. Jon Skare.
[00:06:32] Jon Skare: Here.
[00:06:33] Wendy Adams: And Brian Stevenson.
[00:06:34] Brian Stevenson: Here.
[00:06:36] Wendy Adams: Okay. Have we... Betty Maloney, are you there? (Silence.) Not yet. Okay. And Nicole Baumgarth is not joining us today, uh, but she will be on subsequent calls. Let me just see if I can find out where Betty is. (Sound of typing.) Okay. Estella, have you joined us? (Silence.) No. Okay. We’re going to go ahead and get started because we’re on a tight timeline. I want to say a few words and then we’ll go around and just, if you could give a short like 2 to 3 sentences introduction of yourself that would be great. Actually why don’t we... We’ll start with that. So, I’m Wendy Adams. I’m a Research Grant Director at Bay Area Lyme Foundation. I know many of you from conferences and dealings beforehand and I am co-chairing this group with Estella Jones who is a veterinarian at the FDA. Why don’t we just go ahead and Pat, have you give an introduction, short introduction of yourself, please.
[00:08:08] Pat K. Coyle: I’m a neurology professor at Stony Brook. I have a long-standing interest in nervous system infections and because of where I practice neurologic Lyme disease and I also direct our multiple sclerosis center and have an interest in neuro-immunology.
[00:08:24] Wendy Adams: Okay. Thank you. Sam.
[00:08:26] Sam Donta: Yes. I was professor of medicine at the University of Iowa and University of Connecticut and finished my academic career at Boston University. I was Head of Infectious Diseases at both Iowa and Connecticut and was involved in the fellowship program as well at BU. I got my interest while in Connecticut in Lyme disease in both basic and fundamental research, and clinical research ending up seeing several thousand patients with Lyme disease. I finished my active practice a couple of years ago, but remained interested and dedicated to education and advancement in the issues of Lyme disease.
[00:09:13] Wendy Adams: Thank you. Brian Fallon.
[00:09:16] Brian Fallon: Uh, yeah. I am a Professor of Clinical Psychiatry at Columbia and I run the Lyme and Tick-Borne Disease Research Center. I’m primarily interested in the neurologic and psychiatric aspects of Lyme disease.
[00:09:34] Wendy Adams: Thank you. Lorraine.
[00:09:38] Lorraine Johnson: Yes. I’m Lorraine Johnson. I’m the CEO of LymeDisease.org. We’re dedicated to patient engagement on one of the largest communication networks in Lyme. I’m also the principal investigator on MyLymeData, a patient powered registry that has enrolled over 10,000 patients. I’ve been involved extensively in government panels, so with PCORI, the Patient-Centered Outcomes Research Institute I was involved on their steering committee, also on their executive committee, and I chair at their patient counsel. I was on their expert open data committee and I’m also on the steering committee of Consumers United for Evidence-Based Medicine. That’s an organization that’s dedicated to promoting evidence-based medicine with patient organizations. So, I have had extensive training with grade from the Cochrane Collaboration which is kind of the granddaddy of evidence-based medicine.
[00:10:41] Wendy Adams: (Sound of typing.) Thank you. Sorry. I’m just trying to... I’m writing emails to see if we can get, Elizabeth, uh, Betty in our group. Okay. So, we’ll skip over Betty for now, unless Betty you’re on the line. Have you joined us, hopefully?
[00:10:52] Operator: Not as of yet.
[00:10:54] Wendy Adams: Okay. Thank you, and... But you’re in process of getting her on here, is that correct, operator?
[00:11:01] Operator: Uh, yes. We do have some more people dialing in for the breakout sessions. So, I’m hoping she will join us shortly.
[00:11:07] Wendy Adams: Great. Thanks so much. Uh, and next, Jon Skare, please?
[00:11:13] Jon Skare: Yeah, hi. I’m Jon Skare. I’m at the Texas A&M Health Science Center and I’ve run a research lab for over 20 years now working on spirochetal pathogenesis with an emphasis on Borrelia species more or less.
[00:11:27] Wendy Adams: Thank you. And Brian Stevenson.
[00:11:31] Brian Stevenson: Hi. I’m a Professor at College of Medicine University Kentucky. I’ve been researching Borrelia for some 25 odd years. Uh, primarily Borrelia burgdorferi. We also do work on miyamotoi, (sp?) relapsing fever, and mayonii (sp?) and there. Glad to be here.
[00:11:51] Wendy Adams: Great. Super. Estella, have you been able to join yet? (Silence.) No. Okay. Well, what I wanted to do is just, first of all, address all of you and say thank you so much for, you know, applying for the subcommittee roll. I think we have a really great group of people and it’s really important that we work together. We want to make this, as you saw from the vision and the mission statement discussions, a very collaborative subcommittee where patients, doctors, scientists, and government voices are heard. I can almost guarantee that we won’t agree on everything and I want to acknowledge that two things can be true at the same time. It’s going to be an intense process. We have, as you saw, the timelines. They’re very short and so that will require a lot of flexibility on all parts. We happen to come from all, uh, places, all time zones almost in the US, from California to New York. So that will require some flexibility on our part, all of us. And I want to acknowledge that up-front and thank you for making this...helping to make this a priority and working on behalf of all the patients and the patient families whom you’ve heard from and I’m sure through your work in Borrelia and tick-borne diseases you’ve gotten to know over the years. We really want to use your professional experience and to use that experience as a filter to understand...get your feedback on and your expertise on how the government and you know US states, everybody involved, the stakeholders, can do what’s best for patients and their families, because that’s really why we’re here. We all... A lot of us here have a scientific bent. We have patient bent. We have different... We represent different parts of that ecosystem, but we really need to use that filter and the end goal is really to work on how the government can better serve the needs of patients and their families. We are... We’ll go through the slide presentation. I want to acknowledge and tell you all that there are members of the public who are on this call as well. I want to welcome them and tell them that they are welcome here even though we won’t be... They won’t have a chance to comment. They will be listening in on our discussion here as we brainstorm and go through the areas we think we want to cover at this point; although we won’t have a final list. This is going to be the start of the process of refining and defining what those ideas and issues are that we want to further address in this process. So, as we talked about, the subcommittees are going to work on presentations and reports to the working group for the meeting in May. And so, we’ll go through the timeline, but it’s very short. It’s basically the first week of May that we need to get the report written for submittal to that...to the working group. So we will have a formal process for voting on the documents and it will be voted on and the process we’re promoting it is a simple majority. This will be made public in a draft format for written public comments and then the working group will take the information from each of the subcommittees and distill that and decide what will be included in a report to Congress just on the process. Uh, to reiterate what Rich said, all information presented during these closed meetings - not today. This is an open meeting. But the closed meetings are treated as confidential and that’s important, because we want people to feel free to share what they’re working on, potentially what hasn’t been published yet, but all of the discussions that we have as a group after this meeting are considered confidential. All the work, let’s see. I’ve talked about that. We will be showing, there will be a summary of what we’re discussing in each one of our meetings available; however, not the content, but just kind of the overarching themes of the discussion. So, in this breakout session we’ll be reviewing the work that we’re going to do together over the next 12 weeks. We want to review the inventory of the HHS and DOD programs and those were emailed to you, I believe, yesterday. Now I know... I just want to say, I know Nicole did not get hers, and we can just take a poll after... When we get there, we can just take a quick poll and make sure everybody got those, because what that inventory is going to be used for is to make sure or to basically tell the government departments the information that we need from them to review their activities and make suggestions for areas of overlap and new avenues of research going forward. We’ll also discuss the National Town Hall. That will be another forum through which patients and their families and stakeholders can comment on what we’re doing and give us ideas and tell us what’s important to them and we’ll also, in this meeting, touch on “next steps.” Okay. I’m sure... Let’s see. Elizabeth is not here yet. It sounds like Estella is not, as well, but we will...
[00:17:30] Elizabeth Maloney: Elizabeth is here.
[00:17:32] Wendy Adams: Oh, hi Betty. How are you? I’m glad you’re here.
[00:17:34] Elizabeth Maloney: I’m great. Thanks.
[00:17:35] Wendy Adams: Can you just take a second to introduce yourself since we missed you on the first introduction, just a few sentences.
[00:17:41] Elizabeth Maloney: Oh yes. Sure. I’m a family physician and my main focus is providing physician education on tick-borne diseases.
[00:17:51] Wendy Adams: Great. Thank you. So we’re back on the timeline. The initial major milestones to get us started: February 15th is when we have to send the final inventory tool to HHS and DOD for completion; and again, they have 30 days to respond, which is why we have to do this up-front because that will give them 30 days and what we’re going to try and do is during that 30 days do a lot of our review and presentations so that we’re really well educated by the time that inventory tool comes back; we’ll have the information presented to us as a group so that we can synthesize the information that comes from DOD and HHS. On February 23rd, uh, by February 23rd we want to develop a set of issues and questions and priorities and this is, of course, a *** (indistinct - 00:18:46) process because there are...we have three fairly big topics: pathogenesis, treatment, and transmission, but we need to basically distill those down into a smaller set of priorities that we can then get information on and write a report on. And on March 9th, the background section of the report to the tick-borne disease working group. So, we will have a more-full...a more full-timeline presented to us. May 4th is the end date, but as Rich was talking about, there are going to be smaller chunks of time and smaller milestones so that we don’t get caught behind and then have a lot of work to do before May 4th, which we’ll have any way, but we have these intermediate timelines and milestones to keep us on track. So, at the end of this breakout session we want to be able to provide feedback to the working group about additional information we need to capture in the inventories that were sent. So, let’s just talk about this a little more. I’ve kind of alluded to it, but this is more information on it. So, we want to find out what they’re doing and what they’re spending with regard to tick-borne diseases. As you can understand, there are a lot of tick-borne diseases and so this is a fairly detailed exercise for them. We want to know epidemiological activities related to tick-borne disease. For us, the important part is basic clinical and translational tick-borne disease research related to pathogenesis, prevention, diagnosis, and treatment of tick-borne diseases and then gaps in the research described above. I know we probably all have opinions on that at the beginning which is great. I think we’ll probably develop them as we talk about it as a group. So, at this point let me just check on what...how we’re doing related to,... Yeah, we’re on time. Okay. So, we’re going to review the inventory. I want to just check. Did everybody see this email that came in yesterday and I want to acknowledge that, you know, we’re on a tight time-frame and I apologize it didn’t come earlier. It came to us just about a day before that. But I just want to make sure and touch base with everybody that they have seen that and if not, I mean we’ll certainly go through it now, but that people got that in their email. Is there anybody who didn’t get one?
[00:21:28] Lorraine Johnson: What? Why do I have two inventories? One for the DOD and one for HHS; they’re the same. Why are there two?
[00:21:39] Wendy Adams: Uh, because they’re different departments of the government; so, they have to have their own and that’s how it was explained to me. So yes, they are exactly the same, but they have to be separate for reasons that have to do with the separate parts of the government. Did anybody not get that email from the tick-borne disease working group yesterday? (Pause.) No. Okay. Has everybody had a chance to at least preliminarily look at it?
(Pause.)
[00:22:19] Lorraine Johnson: Uh huh.
[00:22:20] Wendy Adams: Okay. So, it sounds like everybody has, which is great. I want to say that, you know, I’d like to get a first read on this. Hopefully if in a day or two you think of other things, You can get that to me and I can communicate that to the chairs. So, let’s just start with a discussion on what you see here and what might be missing or opportunities you think for additional information that would help us in our role as, you know, the subcommittee on pathogenesis treatment and transmission.
[00:22:55] Pat K. Coyle: This is Pat Coyle and obviously I’m biased, but do you not think it’s important enough to pull out as research topics, “nervous system involvements specifically?”
[00:23:10] Wendy Adams: Okay, Pat. So that’s a good point. I think my guess is we won’t be able to ask for an inventory of what has been done on specific, you know pathophysiology. I don’t think we’ll be able to get down to that level of detail, but I do think that we can. We might be able to ask clarifying questions after the first inventory is in, but I take your point that when we are looking at specific problems with infection or symptoms of infection that we will want more information then might be given. So, let’s put that in the parking lot and see if we need to revisit that based on what comes back to us.
[00:24:05] Pat K. Coyle: Okay.
[00:24:05] Sam Donta: What do we do with these inventories?
[00:24:08] Wendy Adams: Uh, the inventories will be used by the... uh, let’s take CDC for example. CDC will have to provide us with the information on the programs that they have been running on tick-borne disease, each separate program, so that we understand in the government all of the different and disparate ways in which tick-borne disease is being approached and investigated and addressed and we will then take that information and you’ll remember that part of our charter is to understand if there’s overlap where opportunities for, you know, clarifying and streamlining can occur. So, the reason that they have to give us that information is so we can do that analysis.
[00:24:59] Sam Donta: So, is our job just to approve this request that’s going to go to HSS and to DOD?
[00:25:05] Wendy Adams: What each subcommittee is doing is under...is looking at this to see if there is individual information that is...that we think we need, to Pat’s point, of how, you know, we need...we want granular information, and that they will then give us information on what each of their departments is doing in tick-borne disease, but that’s the 30 days. So, they’re going to take these requests, put together the documents behind the requests, and send them to us and then we will evaluate them. We are all getting the same... We’re only putting one in inventory request out from all the subcommittees. So, we don’t have a separate one and, you know, vaccines and therapeutics doesn’t have a separate one. This, the FACA, the advisory committee put that one request to the committee. So, they... Or to the individual departments so they don’t have six different requests to go through. Does that make sense?
[00:26:10] Sam Donta: Yes. I... So, we’re to come up with, “Is there anything missing in this document?”
[00:26:17] Wendy Adams: That’s correct. That’s correct. And is there any... Are there any more specific, aspects that we want them to consider or to provide us? I have one, for example, just to give you an example, I don’t think six years of funding information or seven years is sufficient. I would like to see more like 15 or 20 years of funding so we can see historical trends over time. So, I wanted to request that. It shouldn’t be... I’m hoping it’s not hard to give and I’m also interested in looking at percentage of budget, right, and how that has changed over time. So those are requests that I was thinking about making and that’s a little more color on something that was already given to them or already in that bucket, but just more data in regard to that particular line item.
[00:27:13] Lorraine Johnson: So, Wendy, could I make a comment? This is Lorraine.
[00:27:16] Wendy Adams: Yes. Hi Lorraine.
[00:27:18] Lorraine Johnson: Yeah, so I’ve gone through this and my comment is with regard to item number 20 which says, “How does your agency/office engage the public and other stakeholders in planning activities and obtaining feedback on activities?”
[00:27:34] Wendy Adams: Uh huh.
[00:27:35] Lorraine Johnson: And I think this should be a bit more specific. I would like to see the word “patients” included in this. “How does your office engage the patient, public, or other stakeholders?” and also, I would like to see this broken out a bit more to include, “in research, grants, communications,” you know that sort of thing. So, a lot of agencies allow you to make comments, but that’s not really bidirectional communication which is what you want to see in patient, you know, in patient engagement. Uh, and the other thing is some of these specific activities that I listed, they matter a lot; like, “Who receives a grant? Are there any patients involved in doing the peer review of the grants and do they have any patients involved in reviewing their communications materials?” You know some of these government agencies do. I mean the Department of Defense does, for example. And so anyway that’s what my comment would be.
[00:28:44] Wendy Adams: Okay. So, kind of globally how are they engaging, not just the public, but patients in particular?
[00:28:51] Lorraine Johnson: Yeah. Patients with the disease.
[00:28:54] Wendy Adams: Yeah.
[00:28:55] Jon Skare: So, Wendy...
[00:28:56] Lorraine Johnson: And also, you know research grants and communications being broken out.
[00:29:02] Wendy Adams: Okay. And I want to just remind everybody, until we know voices, but certainly for note-taking purposes, if you could give your name before you make a comment. I know that’s kind of cumbersome, but if you could remember to do that. It makes note-taking easier. Thanks.
[00:29:20] Jon Skare: So, Wendy, this is Jon Skare. I wanted to follow up on the point that you made about digging deeper for further years of support. Maybe it wasn’t implicit in what you were saying, but I think it would be better to get individual years in terms of what those dollars are as opposed to what looks to me like they want or they were going to list from fiscal 10 to fiscal 16. That would be one lump sum, which wouldn’t be very useful, but the idea of having individual years would be good in terms of seeing growth and years that were up and down and the like.
[00:29:54] Wendy Adams: Yeah, thank you. That’s what I meant, but you’re right to call that out, because I could see how somebody could misconstrue it. So yes, I did want individual years and that’s a good clarification that we should provide and we’ll be providing these and Pat, I’ll definitely bring up the neurological and see how we could maybe build that in. We will be providing these in an open session after we meet as a subcommittee today. So, I just want to say that that’s one of our deliverables. Okay. So, I hear Lorraine and Jon about the specifics and Pat about the neurological. I had... Let’s see. I also... I’ll throw something out here, because I think what’s interesting is that we have all these lists of tick-borne diseases, but we...you know we don’t do anything in combination. We don’t seem to study what it’s like when somebody be it a lab animal or in-vitro or a patient have two or more of these diseases concomitantly and I want to just throw that out. I would like to get more information. If indeed there are programs that study that, I’d like to have those called out and know about them. I certainly have seen very little evidence of that aside from, you know, studies on ticks. Any comments on that?
[00:31:23] Sam Donta: You don’t think that that’s covered?
[00:31:24] Brian Fallon: I think that... This is Brian Fallon. I think that’s a great idea, because There’s basically no work, as far as I know, looking at or very little on the impact of dual co-infections.
[00:31:38] Wendy Adams: Somebody else was going to make a comment.
[00:31:41] Sam Donta: I wondered whether it wasn’t covered under the lists of each of the tick-borne diseases that they’re going to check off - several of them - and then the follow-up I guess would be... I’m not sure I understand what their response would be to your question.
[00:32:08] Wendy Adams: I think,... Yeah, I think... I don’t know that much is being done that way, to Brian’s point. So, I think I just want them to note it for us when something does cover more than one infection at a time and the effect that that might have on disease processes, especially pathogenesis.
[00:32:30] Sam Donta: Do you know of any such situation with either HHS or DOD?
[00:32:36] Wendy Adams: Well, I don’t and that’s why I want to know about it, but I do know that a lot of the tick work, you know, certainly a lot of the work in vectors is...evaluates co-infections in the vectors. So... Or you know what happens and there is research that shows that there might be different expression or what happens when there’s co-infection with different species of Borrelia in the same tick. So, I’d just be... I mean I think it’s something to be evaluated.
[00:33:06] Pat K. Coyle: This is Pat Coyle. There’s some very much earlier work that suggested co-infections lead to a more severe infection or somewhat more of refractory and then later studies that didn’t find that. But those are very, very limited studies. So, I think the point of view of the clinical impact of co-infection is a valuable one.
[00:33:28] Elizabeth (Betty) Maloney: Right. I know Zeichner from the CDC... This is Betty. He did look at the transmission of anti-plasma and Borrelia together in mice and the effectiveness of doxycycline in it and showed decreased effectiveness for preventing transmission. So, I think that’s the only dual infection study that I’ve run across.
[00:33:52] Wendy Adams: Okay. Good. Well, we can take that up, but as far as just keeping on the list of what else we might want to search for or ask for.
[00:34:02] Brian Fallon: This is Brian. This is Brian, again. One thing that’s not on any of these forms is the difference between studies and research and attention paid to acute illness, acute infection versus chronic illness. Chronic illness is such a huge problem in this country for a subgroup of the patients. So, if the government continues to focus all the time on acute illness and doesn’t spend enough on focusing on people with chronic symptoms, we’re not going to learn. So, it would be really nice if there could be a box here on studies of post antibiotic symptoms or post-treatment symptoms or chronic symptoms that would be informative as well.
[00:34:50] Lorraine Johnson: You know I would add to that, Brian... This is Lorraine. I would add to that late stage Lyme, because we’re finding in MyLymeData that a lot of the people weren’t diagnosed until late stage and that’s before treatment with antibiotics.
[00:35:05] Sam Donta: Uh, Sam here. I don’t think we need to call it late stage. I mean you can if you want, but basically, we’re saying people who have persisting relapsing symptoms and I’d rather just use those terms or ongoing symptoms or chronic symptoms and I agree, Brian, somehow in this inventory, “Is their attention?” Like in our DOD grants we do specify one of the program objectives is to focus on, “How do you diagnose and treat chronic ongoing symptoms?”
[00:35:45] Pat K. Coyle: I think what Lorraine was talking about, though, is, studying acute people who are treated acutely versus people who are not treated and not diagnosed for months or years. Right? So...
[00:36:01] Lorraine Johnson: Yeah. That’s exactly right, because we’re finding really large numbers of people are not diagnosed until after six months of infection.
[00:36:11] Pat K. Coyle: Uh huh.
[00:36:12] Sam Donta: Well, that just...
[00:36:12] Lorraine Johnson: And they haven’t been treated with antibiotics. So, you know it’s not like, “Oh and you were treated and you still have symptoms?” It’s like they were not treated in the first place.
[00:36:28] Wendy Adams: Okay. Is there anything...any other comments that we want to bring up to the big group about items we would like included in the inventory review?
[00:36:43] Sam Donta: And who’s... Sam here. Who’s going to receive these inventory requests and who’s going to complete them?
[00:36:49] Wendy Adams: It will be the staff of the individual departments in HHS and DOD. So, there will be push-back on adding more detail (chuckle) as you can understand.
[00:37:01] Pat K. Coyle: This is Pat Coyle. A lot of the public testimony focused on Alpha-Gal and that’s not specifically mentioned here. Obviously, it’s an allergic, not an infectious condition. Is that going to be covered? What was the decision on that?
[00:37:16] Wendy Adams: I think it will be where there is information on it. It will be covered under “other tick-borne disease” and that would be the hope, but yes, that would be assumed to come under the “tick-borne disease” umbrella, but we are... There is a co-infection subcommittee. We might touch on a few co-infection items in our subcommittee, but it’s... We have a lot to do with Lyme disease and that’s why the decision was made to break out the sub, another subcommittee just on co-infections and other diseases. So, but yes that is thought to be included. So, areas like CDC will have something on Alpha-Gal, I’m assuming when they send their inventory back as that is another tick-borne disease. Okay. Anything else in this that you can think about right now? (Silence.) Okay. So, we’re going to move on now to the National Town Hall Meeting. What we’d like to do is come up with any questions or issues we’d like posed at the Town Hall so we can receive input from the patient community or from the community of stakeholders that takes place in the Town Hall. Does anybody have after... Listening to you, I realize you only listened to a subset of the... You know we heard a lot more from patients early on at the first meeting and not at this meeting, but as far as, you know, especially for... I think of Brian Stevenson and Jon Skare who maybe deal with patients less and deal with really the early pathogenesis - which everybody else as well - Are there any questions you want addressed at the Town Hall for people to weigh in on before we star or as we’re going through this process? Issues could be of interest to state and territorial epidemiologists. It could be questions for the CDC. It could be questions of, you know, asking patients to weigh-in on something.
[00:39:50] Lorraine Johnson: Wendy can you... This is Lorraine. Can you explain what the Town Hall is?
[00:39:55] Wendy Adams: So, the Town Hall Meeting is going to be another public meeting with an open mic for people to comment on the process. There will be...you know and I, we haven’t done our own run through of the Town Hall, but what it’s going to be is another chance for a kind of dialogue on what should be approached and what should be studied in this process and another chance for stakeholders to raise issues that they believe should be evaluated during this process.
[00:40:36] Lorraine Johnson: So... This is Lorraine again. So, one item that I would suggest would be a question of, “What are the outcomes that patients regard as important in Lyme disease?” Because a lot of the studies are about doing things like getting rid of a rash. Well, patients don’t care about getting rid of the rash, in my experience; they care about being restored to health. But a lot of the studies focus on endpoints that are different than what patients regard as important. So that would be an interesting topic.
[00:41:10] Wendy Adams: Okay.
[00:41:12] Brian Stevenson: Hi, it’s Brian Stevenson. You asked about our concerns or my concerns and Jon can chime in with his opinions. Uh, I mean my biggest interest, I guess, is scientific rigor in the various studies, avoiding anecdotes, and really good solid science, laboratory studies on the biology of Borrelia and how it interacts with its hosts and what it’s doing inside hosts, whether it’s mice or rabbits or monkeys or whatever; things where we can actually look inside the mammal and see what’s going on, where the Borrelia are, what they’re trying to do, their forms, sort of things like that. You know, I think that kind of research is really going to address a lot of the questions that people have. We hear a tremendous amount of anecdotal evidence, “I think this happens or I want this to happen kind of thing” and we need to know what really happens so that patients are being treated accordingly, appropriately, and physicians could understand what is going on with the disease, patients can understand what’s going on with the disease. It’s heartbreaking when I talk with patients and it’s very clear that I know something is wrong with them, but I’m really not sure what they have and a correct and appropriate diagnosis in treatments is absolutely essential and yeah, I’ll let other people speak up too.
[00:42:55] Wendy Adams: So, what is the... Brian, is there a question or is that something you want scientific rigor discussed from a scientific perspective at the Town Hall? Like what’s the question? Is there a question there to patients or to stakeholders?
[00:42:18] Brian Stevenson: Well, what did I say. Uh, I guess, yeah. Everybody... Remember, uh... I don’t know. Let’s use scientific rigor and not untested treatments or diagnostics that somebody made up and have never actually tested in a rigorous manner, but has been applied to patients and when there are proposed diagnostics or treatments or other analyses that they be rigorously followed through to see, “Is this really legitimate or not? Is this really going to be a valuable tool or are we wasting people’s money and time and possibly lives?”
[00:44:02] Sam Donta: Sam here. I’m not sure whether we’re going to tell the Town Hall what we think needs to be done. I don’t understand how we’re going to get the information, aside from what Lorraine said, reactions to... I mean of course there should be the best science, uh, done. I don’t understand how we’re going to engage here. I think the purpose of the Town Hall is just to get their input about in our subcommittee is pathogenesis and treatments and transmission. So that should just be an open question as to, “Do they have questions or comments regarding what needs to be done about pathogenesis, transmission, and treatment?” Then the expectation is going to be, “We need more science. We need more data.” Uh, and in the absence of data, this is one concern I had, Wendy, on the core values. It all sounded very good, but what was missing is if we never come up with or can’t come up, as we currently have in place, definitive data to know, as Brian said, “How do you know whether they’re still infected or not infected?” That is the central question. What do you do? You just say, “I don’t know what to do, therefore, see somebody else.” Or, “What is the available evidence?” And you can talk about evidence-based but evidence-based data in patients with ongoing symptoms is very weak. So, it really depends on people’s ability to analyze, scientist’s ability, physician’s ability to analyze what patients are saying and I mean... I think that should go into the core statement. In the absence of definitive data there needs to be respect for individual physician/patient decision-making, but we may be able to ask them, what do they think basically about treatments and introduce it with the term scientific rigor; because people are all over the map about treatments and it gets crazy.
[00:46:30] Wendy Adams: Yeah and I would... I mean, to Brian’s point, I understand that there needs to be scientific rigor and so I think the question is, “In the absence of perfect data/evidence - so we had a big discussion about data and evidence off-line - how do we prioritize what we need the most and provide feedback to the government?” That this is what we need, this is what’s needed to be...needs to be funded. Because there’s not, you know, there’s not an unlimited amount of resources and that’s been, you know, sadly shown time after time is that there a lot of good studies that need to be done; however, there’s just not that funding available. So, in the absence of that, how do we prioritize what we need to find out? And in our areas, it’s you know, transmission, treatment, and pathogenesis. How do we evaluate what’s most needed and advocate for that getting funded? Because we can’t fund all of what we want to fund to get perfect data and in the absence of that, how do we prioritize? So, I want to kind of close up this discussion for right now and get on to, hopefully, looking at our agenda for the second meeting and you’ll have to forgive me. I got kicked out of my... I’m not sure I’ll be able to advance the slides, because I got kicked out of this. So, if I can’t advance the slides, We’ll just go through what’s written on them instead. Okay. So, for the second subcommittee meeting, and as we talked about, you’ll be getting a poll, a doodle poll; which if some of you haven’t used, it’s basically a scheduling tool so that we can write down what’s needed or where we’re available on a weekly basis so that hopefully we can come up with a static time from week to week where we agree to meet for an hour or two, an hour and a half, and this is where the work and the presentations will be given. So, it’s important to get that scheduled as soon as possible. But I want to talk about the agenda for the second subcommittee meeting. So, the first is the potential list of issues to be addressed by the subcommittee and that is, obviously, a bigger task than... That’s our first big task, right, because that is taking all of the pathogenesis treatment and transmission and kind of distilling it down based on what we think is most important. We have to come up with a list of 3 to 5 things that we want to address and then do the work on those areas. So, getting the speakers to do, you know, lit reviews or provide their feedback on what is currently known and what’s not known; what are the opportunities to learn more? And then, we want to, you know, we basically get the list of 3 to 5. So, and then we get our timelines going. So, I don’t... Let’s see. I want to think about... If you could give me, you know... If we could spend 5 to 10 minutes talking about what our top one or two issues to be addressed during this. It could be in any one bucket and this is not the final discussion on it, but I want us to start thinking about it so that when we have our next meeting, we can get to a finalized list pretty quickly so we can start on the work. I know all of you come from... You know we have representatives from every group here and I think that’s key to getting a great group of issues to address. I have no doubt that it will be more than we can possibly take on, but I want to start that discussion now. So, I would... Yeah. So, let me start with... I’ll go... See if I can go kind of reverse alphabetically this time. Brian, what would be your top issue or two to devote or to understand during this process that you want to undertake an evaluation of?
[00:50:52] Brian Stevenson: Not quite following what you’re asking.
[00:50:57] Wendy Adams: Okay. So, we have three issues... We have three areas that this subcommittee is tasked with evaluating: pathogenesis, treatment, and transmission. We need to come up with a refined list of areas or issues or topics emanating from those three areas that we then will take forward and evaluate. We’re not going to, we probably can’t take on all of pathogenesis. We can’t take on all of treatment, and we can’t take on kind of everything we want to do in transmission. So, we need to brainstorm and come up with a list of topics that we are interested in doing the work on and believe would be of most help to patients and physicians and the rest of the stakeholders in Lyme disease. So, is there one issue or two in pathogenesis, for example, that you think we should be evaluating during this process to give feedback on to the government for their response and evaluation?
[00:52:02] Brian Stevenson: I would say the two key areas that I see as highly significant are the mechanisms of how Borrelia burgdorferi gets out of a tick and initially infects and colonizes the host, disseminates what’s going on in there and as intriguing is, what happens in the untreated patients, the untreated animal? How on earth is this bacteria with its surface covered in antigenic proteins not cleared by the immune system? Where’s it hiding? What’s it doing? And understanding that I think is going to tell us a lot moving forward for understanding and treating Lyme disease at many, many stages.
[00:52:49] Wendy Adams: Okay. Great. That’s exactly what we’re kind of looking for, which is specifics on items to evaluate. Jon Skare.
[00:53:02] Jon Skare: Uh, yeah. I mean I would echo what Brian said there. In regard to persistence, I think that that’s been a real big, you know, area of interest is how these organisms are able to persist in the face of a really robust and in an adaptive immune response. Also, other things that I was thinking of and I know that there’s been calls in years past and I don’t know what the status of those studies are in terms of distinguishing active from prior exposure and the mechanisms that are involved in that. In terms of distinguishing between that would be really important, obviously, for treatment purposes. And then also may be looking at other ways of evaluating detection and blocking transmission, things along those lines, where you would engage with more non-conventional or more biomedical engineering approaches coupled with those that are merged with biologists to come up with, you know, more novel approaches for treatment. I know it’s kind of out there, but something along those lines I think would be really helpful, too, in terms of where the future might be.
[00:54:14] Wendy Adams: Uh, great. Thanks for the feedback.
[00:54:16] Brian Stevenson: Hey, it’s Brian Stevenson. Could I just chime in with something again, please?
[00:54:20] Wendy Adams: Sure.
[00:54:21] Brian Stevenson: And I’d like to clarify, there seems to be the word “persistence” used in two different forms in the Lyme and Borrelia community. What I was talking to...about and I believe what Jon is also talking about is the ability to Borrelia to persist in an immuno-competent animal or patients without antibiotic treatment. So how does it do that? That I think is a really significant key question to understand what’s going on in the biology of Borrelia and Lyme disease. It’s also been applied to the concept that Borrelia can avoid killing antibiotics and there’s been some recent papers along that line with animals or patients that possibly still have it and my opinion, that’s basically treatment failure. It’s inadequate treatments of not long enough or not the right antibiotic or not enough of the antibiotic and so that’s a whole different question of reevaluating perhaps treatment options. There’s no evidence. Well, we’ll have to wait and see. But just I think with our group and with everybody else, when we talk about persistence I think it’s important to keep those two definitions of persistence very separate and make sure that we know exactly what we’re talking about and what people are talking about when they bring up persistence. Thank you.
[00:55:38] Wendy Adams: Okay.
[00:55:38] Lorraine Johnson: So, this is...
[00:55:41] Wendy Adams: Okay, go ahead Lorraine.
[00:55:44] Lorraine Johnson: I just wanted to say that Lymedisease.org did a very large survey that involved a lot of people who were - a lot of you actually and Kristin Honey - who were gathered together one meeting to develop the top 10 research priorities. We then went out to the community and drew over 7,000 responses. I want to mention a couple of the things that were on this list. “What is the most effective treatment protocol to restore health to patients with Lyme disease? And what is the impact of delayed diagnosis on the course of Lyme disease?” So those were two of the top ones; along with, you know, “What direct detection method would be effective?” I’m happy to share this list with anybody who’s interested. We did a press release on it. It’s publicly available.
[00:56:34] Wendy Adams: Okay. Why don’t you share that with us? I want to just, before we go to Betty… Brian Stevenson, I want to address something or just acknowledge what you said, which is there are two different things...two different maybe definitions of persistence that we use in the Lyme disease research and treatment community; however I think they’re linked, because I think that patients still need an immune response to, in addition to antibiotics and I think that maybe the same mechanisms that are used in animals or humans or by the Borrelia to evade the immune response might be connected to what happens with treatment. So, I think you’re right in that they’re two different things, but they might be linked and I’m hoping that maybe we use one to inform the other. That might be heresy where you come from, but I think from a…but if I look at it from a patient-centered viewpoint, I don’t think they’re distinct maybe in their practical applications. In a research sense, they are very distinct and I understand that.
[00:57:39] Brian Stevenson: Yeah. Thanks. This is Brian, again. I’m cool with that. I’ve got enough experience to study that. Thanks.
[00:57:44] Wendy Adams: Okay. Great. Betty.
[00:57:48] Elizabeth Maloney: I’m interested in how the bacteria and host interact and if there are variations in the immune response between... Is that based on host or strain or just the differences that we see, because patients are presenting in so many different ways. I’m also very interested in whether the immune response can really continue to cycle without the bacteria being present. So, is there immune uncoupling from the infection? I’m interested in that.
[00:58:23] Operator: Pardon me. This is the operator. You have approximately two minutes left until you rejoin the call. Thank you.
[00:58:30] Wendy Adams: Okay. Thanks Betty. Brian Fallon.
[00:58:35] Brian Fallon: If I was going to choose just one or two things I would say my interest would be on bio-markers to guide treatment, selection, and... Actually, three things. The second is, “What leading studies on how to help patients with chronic symptoms?” We need well-designed and well-controlled studies, not just antibiotics, but also immune modulators, other types of brain interventions, uh, possibly micro-bio studies and finally, we can’t forget the fact that Powassan (sp?) Virus exists and that there’s no money for it to study it, because not that many cases exist in the US, but the Powassan (sp?) Virus infection here is increasing in the Northeast which would suggest that it’s going to be a bigger problem and therefore we need to identify treatment for Powassan (sp?) Virus.
[00:59:28] Wendy Adams: Great. Sam.
[00:59:30] Sam Donta: Yeah. I think mechanisms of persistence whether people have been treated or not is key and markers of persistence, whether it’s metabolomics or other markers; direct detection. And then to speak to what Brian had said too, antibiotic tolerance is also probably an important key here as it’s been found for other bacteria. The immune response has been rendered mute in this disease. It’s still important to try and study it, but I think the key is going to still be antibiotic treatments that work on persistence.
[01:00:06] Wendy Adams: Great. And lastly, Pat.
[01:00:09] Pat K. Coyle: Under pathogenesis, “What subset of Lyme patients, early or late, have CNS involvement using sophisticated or imaging techniques to detect CNS inflammation or circuit disruption and molecular techniques to look at CSF to look at immune inflammatory markers, changers that might be contributing to symptoms or persistent in section?” Under treatment, “best antibiotic regiments and what penetrates for neurological infection would be better off being, uh, using penetrating regiments early on to avoid late issues and transmission identification neurotrophic strains.”
[01:00:46] Lorraine Johnson: Uh huh.
[01:00:47] Wendy Adams: Okay. Great. I’m just typing just to make sure I have this, so great. Well, I’m sure we’ll get bounced pretty soon, but I just want to thank you all for engaging. I think we’ve had a good discussion. Now that you know the devil is in the details on this which I’m sure you all know with working with Borrelia. So, I will, you know, try and represent this to the extent we are asked to do it and the next part of the call I know, at least for the inventory, that will be important, but I’ll try and distill this down to maybe a few key topics. I think “persistence” sounds like that runs across kind of pathogenesis and treatment and patients and that just, at first glance, is really what’s rising up for me. So, I will kind of look at all the feedback and try and put together a slate and I say, “I.” I mean myself and Estella - who I’m hoping is on - and other people at FDA, but I... So, I do want to acknowledge her as another co-chair, despite my use of “I.” So I want to thank you for that and keep thinking about this. Keep, you know, reviewing. I’m going to ask some of you to present to the group for your knowledge, what you know, the gaps, kind of where we have more time to evaluate them and go deeper onto some of these issues. Again, that will happen in the next month before we get this federal feedback from the different departments on the inventory.
[01:02:29] Sam Donta: When do we expect to hear from you next?
[01:02:32] Wendy Adams: Soon; within probably the next day or two. I also have a... I put together the listing of all the emails. So, I’ll send out something in the next day or two with that email list so when you’re applying or replying, you can reply to everybody and I think that’s an important, that will also include the federal officer and John Aucott, who we need to have on our emails for, you know, Federal Advisory Committee purposes. Okay. Anybody have any questions that I haven’t answered?
[01:03:10] Brian Fallon: This is Brian Fallon. In terms of scheduling next meetings, the idea of having a meeting scheduled with only a 24 or 48-hour notice is really hard for clinicians, especially, who have patients who plan to come from far away to see them. It’s just very hard. So, the more notice the better.
[01:03:31] Wendy Adams: My intent is to have a weekly time that we have scheduled and that we don’t deviate much from that time. It’s just a matter of, for regulatory purposes, regulations purposes that we have to provide...have to be scheduled in advance. So, my intention is not to schedule things 48 hours before. We’ll just, you know, we have to see who we have on our list to present, but my desire and wish is to have one time every week so everybody knows they can block that out on their calendar. That’s why you’ll be getting the doodle poll to mark off the times that work and don’t work so that we can see, you know, what...how many of those times are available a week. I’m guessing it’s not many, given that we have so many people on the committee and there are different time frames or different times.
[01:04:21] Operator: Pardon me. This is the operator. You’ll be transferred back now. Thank you.
[01:04:25] Wendy Adams: Okay. Thanks everybody.
[01:04:27] Sam Donta: Thank you, Wendy.
(End of breakout session 2 - 01:04:30.)
Breakout Session 3
Testing and Diagnostics Subcommittee
Steve Schuster: Steve.
Deborah Hoadley: Deb Hoadley.
John Aucott: Yeah. So, I think this is supposed to be the testing and diagnostics call. So maybe we could do a quick roll call and people could identify... Again, this is John Aucott. Lise is trying to get in, but isn’t in yet. So, could we just one at a time kind of tell me who’s on the line?
Steve Schuster : Let’s just back up a bit. We’ve been on trying to get... We cannot get onto the Adobe Connect.
John Aucott: Right. I don’t think we need the Adobe Connect.
Vanilla Singh: Uh, actually this is Vanilla Singh and I just got onto the Adobe Connect for the testing and diagnostics. So it is working.
Steve Schuster : Hmm and after all of that *** (indistinct - 00:00:49.)
John Aucott: I don’t think it’s essential, guys.
David Roth: Yeah, it’s only essential if there’s some kind of presentation. Is there a presentation?
John Aucott: There really isn’t. So, I mean, I can guide us through. Lise is supposed to be co-chairing this, but is in an airport and is having trouble getting in. So Lise isn’t on the call. So, I can get us through the work. It doesn’t require the Adobe Connect to be...
Steve Schuster : Okay. Let’s go. Let’s go.
Vanilla Singh: Okay. Perfect. Then John, why don’t you lead the way?
John Aucott: Yeah, so I’m going to lead the call since Lise isn’t here, but... So, I’m going to start with a roll call. I’ll just go through the list. Charles Chiu, are you present? (Silence.) Roberta DeBiasi?
Roberta DeBiasi: Yep. DeBiasi. Yes.
John Aucott: Thank you. Sorry. Noel Aurel. (sp?)
Noel Aurel: Yes, I’m here.
John Aucott: Excellent. Deborah Hoadley?
Deborah Hoadley: I’m here. Can you hear me?
John Aucott: Yeah. You’re a little crackly, but yes. Maliha Ilias?
Maliha Illias: I’m here.
John Aucott: Thank you. Bobby Pritt? (Silence.) Okay. No. David Roth I heard. Right, David?
David Roth: I’m here. Yep.
John Aucott: And Steven Schuster. So, we’re good. We’ve got a good group here. So I’m going to go ahead and lead the meeting. We’ve got about 40 minutes. So we’ve got plenty of time actually. So we’re going to start with introductions. So, I’ll again read off your name and if you could just give us, you know a five sentence two-minute introduction to yourself and what, you know, what brought you to this group. So let’s start with Roberta.
Roberta DeBiasi: Hi there. Sorry. I was on mute. So I’m Roberta DeBiasi. I’m the Chief of Infectious Diseases at Children’s National Medical Center. I’m a professor at George Washington University. We see lots of children with Lyme disease, so I’ve been involved with it from a clinical standpoint for...here in the DC area for about 12 years. We see about... When we’ve done our ICB-9 searches we see... I think we’ve had about 300 hospitalized children over the last 10 year period and then, you know, a much higher number, maybe 800 from the ER in that period and we’ve been very interested in collecting data both for diagnostics, but also for long-term outcomes and we have a grant now where we’re looking at neuro-cognitive issues with these children and getting more objective data. So that’s sort of a short version of my interests in the tick-borne issue.
John Aucott: Perfect. That was a perfect example for everyone. So Noel, you’re next.
Noel Aurel: Hi. Yes. So I’m at the FDA. I’m in the Center for Devices in the group that reviews clinical diagnostics for the commercial labs. I’ve been in this position I think since 2010, 2011 and tick-borne diseases are one of the areas that I’m on task to review; so Lyme disease, *** (indistinct - 00:03:54) diseases, a little bit of babesio. Prior to that I did a little bit of kind of basic research in malarian and babesio from like 2008, 2009.
John Aucott: Thank you, Noel. Deborah.
Deborah Hoadley: So my name is Deborah Hoadley. I’m an infectious disease physician and also trained in public health and preventive medicine. I’m up in New England. I have a private practice and I’m also affiliated with an academic teaching center in Western Mass that’s affiliated with UMASS and Tufts and I see lots of patients and have more recently become involved in a research project involving direct testing methods and nano-particle concentration technology. So I’m very interested in diagnostic methods and also interested in clinical case definitions and how we can work to improve those.
John Aucott: Excellent. Maliha.
Maliha Illias: Hi. This is Maliha Ilias. I am the current Lyme Disease Program Officer at the National Institute of Allergy and Infectious Diseases and essentially I manage a portfolio of extramural grants that focus on pathogenesis, diagnosis, prevention, and treatment of Lyme disease and other Borrelia related diseases and infections. I have been in this role fairly short period of time, only two years. I joined in 2016 January. Before that I was working in the bacteriology and mycology branch which houses the Lyme disease research portfolio that I was working as the preclinical services product development manager. What essentially that role does is manages all of our branch and contracts focused on drugs, diagnostics, and vaccines for infectious diseases, for bacterial and fungal and before that I was... I finished my PhD at Johns Hopkins School of Public Health and with focus in reproductive health, maternal and child health outcomes, global health, as well as health communication. I’m excited to be here.
John Aucott: Excellent. Bobby, have you joined us? (Silence.) Okay. We’ll move on to David Roth.
David Roth: Hi, my name is David Roth. I am recently retired. I’m certainly the odd man out here not having a medical or research science background. I was brought to this table through personal illness. I was, you know, most recently a partner at Blackstone and in 2010 I got acute *** (indistinct - 00:060:33) with what ended up being diagnosed as Lyme disease and babesio. It took me a long time to get better and, you know, through that and sort of in the search for meaning I became very actively involved in the advocacy world, you know, with the goal of helping with the world of the challenges that, you know, patients face from these diseases. I was originally with a group called The Tick-Borne Disease Alliance which merged to form, uh, with another group to form Global Lyme Alliance. I’m currently with a group called Project Lyme, but you know, my hope is that, you know, through this working group we can really sort of address a lot of the gaps and our understanding, to me, you know, diagnostics have always been the linchpins for how we’re going to make progress and science, all of you guys, you are the answer to all the controversy and all the challenges. So my hope is that, you know, we make real progress here and find a way to have more centered specific, reliable, and cost-effective tests in the future and one, that, you know, the government, insurance companies, and the medical community can all back.
John Aucott: Thanks, David. Steve Schuster.
Steve Schuster: Hi. Thanks for having me. So I’m a physician scientist. I trained in, research-wise, in microbiology and immunology. I have along the way, in different other diseases, developed laboratory tests, both immunological and molecular. And so I’m continuing along those lines with Lyme disease. I think, you know, I’ll reiterate what David Roth said as far as the goals, but perhaps something that I can bring to this group and to the other people on the group participating in this is I organized and co-chaired a meeting at Cold Spring Harbor Laboratory on assessing current diagnostics for Lyme disease and new ones that are either here or around the corner, so to speak, and we published the first part of that already in the clinical infectious diseases. So, what that and the combination of the other group, it may really help jumpstart the committee’s work, because we had approximately 30 people assessing... We had diverse fields and diverse disciplines looking at the weaknesses of the current systems and the strengths of some newer platforms. So, I’m hoping that will steer us ahead—no pun intended—quickly.
John Aucott: So great. I didn’t really formally introduce myself. So, I’m John Aucott. I’m the chair of the working group and this is...Kristin and I split up the working groups. So actually, Kristin is going to be following this working group in the future, but I’m just stepping in for a Lise since she’s not able to connect. And I run the Johns Hopkins Lyme Disease Research Center in the Department of Medicine at Hopkins. So we’ve got some, basically three goals now. One is, I want to answer any questions that people have and then, two, is to look over this inventory draft. So while we’re talking, everyone should put your hands on the inventory of “HHS tick-borne diseases projects and activities.” There’s one for HHS and there’s one for DOD, but they’re the same. So, while we’re taking a few questions, everyone get your hands on the inventory, because the next step will be to look at that and make any suggestions that we want to have input into the working group about the final inventory that goes out to the different agencies. So, while you’re getting your hands on that and looking at it, are there just any general questions? I mean Rich and I, you know, went over a lot of stuff real quickly, but do people have questions about how the subcommittee works at this point?
David Roth: Uh, a couple of things. Where is this inventory that you’re referring to?
John Aucott: So there was an attachment that went out to you all in an email that was called, “the inventory of HHS tick-borne disease projects and activities.” It was an attachment that went into that blast of emails you got and it’s a graph of... It looks like text and then a bunch of boxes where you, you know, where the different types of activities are that we’re going to ask for in inventory from CDC and NIH and different federal agencies.
David Roth: Uh huh.
Steve Schuster: I think *** (indistinct - 00:11:26.)
John Aucott: Do you know what I’m talking about?
Steve Schuster: I just forwarded it to you David.
David Roth: No, no. I found it. I found it.
Steve Schuster: Okay.
John Aucott: Any other questions?
David Roth: Yeah, the only other question I have is procedural in nature. I know we’re not allowed to talk openly about the proceedings on these phone calls. Are we allowed to talk about the issues with people who are outside of this if we don’t go into what was discussed?
John Aucott: I think the way I understand it is, when you’re a, you know, your private citizen life and then how that relates to tick-borne diseases doesn’t really change. You know, if you always talk about stuff that, you know, you keep talking about that you would never talk about anything that relates to your activities at...on the subcommittee, so that, you know, you don’t... You would never... I sort of look at it as a physician; it’s sort of like HIPAA, you know. You would never talk about a patient or anything that, you know, was confidential between you and a patient, but you know, your general comments on tick-borne diseases are fine. In this case, you would never talk about something that was a conversation, like the one we’re having right now or the ones you’ll be having, you know, on a weekly or biweekly basis. You would never talk about those discussions and you certainly would never impute any statements to any individuals during those discussions; but you know, if you’re out there talking about your story and your history and your beliefs as a private citizen, the way you’ve always have, that’s certainly what you should keep doing.
David Roth: Okay.
Lise Nigrovic: Hi. I’m sorry to interrupt. I finally got in. This is Lise Nigrovic. Sorry about that.
John Aucott: Lise, I did your job. We’re done. Sorry. (Laughter.)
Lise Nigrovic: Okay. Well, thanks. That makes it... That’s easy. Sorry, I... The line was not working. The computer wasn’t working, so.
John Aucott: So actually, we just introduced everyone.
Lise Nigrovic: Sorry about that. Have we got everyone and we’re all done?
John Aucott: (Laughter.) You can introduce yourself and then we were just going to go into the inventories and review the inventory. So, I’ll hand it over to you to introduce yourself and then we’ll go on to looking at the inventories.
Lise Nigrovic: Sure. So, can you just fill me in on who’s on the line since I missed all of the important part?
John Aucott: Exactly. Everyone is on...from your committee is on the line except Charles Chiu and Bobby Pritt, otherwise you have everyone on the line.
Lise Nigrovic: Great. Well, welcome and thanks for agreeing to participate in this. For those of you that I have not met, my name is Lise Nigrovic. I’m a Pediatric Emergency Physician at Boston’s Children in Boston and my interest in Lyme disease really relates to children and the diagnosis by clinical and laboratory methods really at the initial point of contact with healthcare. So the... And the...to improve the initial approach to children with potential Lyme disease. I don’t know how in-depth we got in to...
John Aucott: That’s about it. Yeah.
Lise Nigrovic: That’s about it. Yes. Great. Well, I look forward to meeting with and getting to know all of you and I thank you for agreeing to participate in this effort. I don’t know if John, you had a chance to address this, but there’s still a to-be-appointed federal co-chair for this committee. Is that...
John Aucott: I did not address that yet. That’s right.
Lise Nigrovic: Yes. So I will... John is ably assisting, but the structure of these subcommittees has been to be public, myself, you know, a member of the academic community, and the federal partner and at this time the federal partner has not yet been identified. So I don’t know... I’m not involved with that. John may not either and they’re going to let us know which will, I think, affect maybe our progress a little bit, but I think at this point in time we can kind of move ahead as we await for that appointment.
John Aucott: Correct.
Steve Schuster: John, Steve here. I just have a question. Somewhere in the readings of these emails or invitations it looks like you could join even a subcommittee. You could listen in, you know, no matter who you are. You don’t have to be a member. So I... You know, can you clarify that if these are, let’s say, closed meetings just to the members or can anyone from the public do it, because that sort of makes a contradiction if someone can’t...if one of the members can’t go and talk about it, but anyone who listens in can.
John Aucott: So, the biggest things I’m learning as I go through this process is, if it’s a working group meeting like today that’s covered by FACA—that universal term that’s used—then it’s open...the public can listen like they are right now. They can’t comment during this meeting, but they can listen because it’s a FACA meeting. When your subcommittees are meeting, those are not FACA meetings. Those are, you know... They’re working meetings that aren’t FACA covered. So those will not be opened to the public, because we want you to have the freedom to have honest controversial discussions and they’re not FACA covered; so we’ve recommended that those not be open to the public. There will be some note taking in the most general terms that will be posted to the HHS website; in other words, who is attending the meetings, what the topics that were discussed, but there won’t be detailed transcripts of the discussions available. Those are all closed meeting. Today is a FACA working group meeting, so that’s why there is public listening in.
Steve Schuster: Okay. Got it. Open meeting today, not a real working group, uh, meeting...not a working session.
John Aucott: Correct. You guys are going to by the... You know, Lise is going to be charged with, you know, getting some schedule together for you all to start meeting on a weekly or biweekly basis and those will all be closed confidential meetings of the subcommittee.
Steve Schuster: Okay. Thanks. That’s very clear.
Deborah Hoadley: This is Roberta. May I ask another question about procedure?
Lise Nigrovic: Sure.
Deborah Hoadley: May I ask another question about procedure?
John Aucott: You’re breaking up a little bit. I’m sorry.
Deborah Hoadley: Okay. Can you hear me now?
John Aucott: Yeah, that’s better.
Deborah Hoadley: Okay. I’ll try again. I did have a procedural question also regarding whether we can discuss things with other subcommittee members if we are gathering evidence, information, or feedback on inventory. Some of these subjects overlap, like prevention, pathogenesis testing and can we share the vision with other subcommittee members in discussion or is that not considered proper?
Jim Berger: This is Jim Berger. I’m the alternate designated federal official officer; so I’ll answer that question. In response to your question, yes, you can share that information. Certainly we would hope that the subcommittees, if they’ve got information that’s overlapping can be cross shared with the other subcommittees. It only benefits the goals and objectives of the charge that we have as the working group. So yes, the answer is yes.
Deborah Hoadley: Thank you.
John Aucott: All right. Well, Lise, you probably should go on to tackle the inventory document.
Lise Nigrovic: Sure. That is the DOD and the NIID or the NIH document?
John Aucott: One is titled, “Inventory of HHS tick-borne disease projects and activities.” They’re essentially the same document. One just goes out to DOD and the other goes out to HHS agencies; but they’re basically, at this point at least, the same document. You know and *** (indistinct - 00:19:53.)
Lise Nigrovic: So you can correct me if I’m... Yeah. The purpose of this at this point in time is as we begin our work, we want to have a good understanding of the current federal efforts in these domains; and so this survey would be used to understand the current efforts.
John Aucott: Exactly.
Lise Nigrovic: And the feedback that we would be looking for would there...if looking this over there would be anything else to include in these surveys that would be germane to our subcommittee on diagnosis.
John Aucott: Exactly. You’re just focusing on what you need on your subcommittee, not the other subcommittees. Exactly.
Lise Nigrovic: You know, it’s sort of hard to start with... So I look these over. I think they are fairly general. I don’t know if people have other comments, but in some ways, you know, before we really dig into the specific efforts around research and our repositories and evaluation of diagnostics, it’s hard to know what we might be missing; but did anyone have a chance to look at this and have thoughts that could be added to this survey? It’s really general. Does everyone have this attachment provided to them, looking at either version?
Noel Aurel: Yes.
Roberta DeBiasi: Yes.
Maliha Illias: Hi, Lise. This is Maliha Ilias from AID.
Lise Nigrovic: Yeah.
Maliha Illias: And I have a quick question, just looking at the inventories. They seem to be capturing a lot of information and for organizations like NIID which funds a lot of research in the form of extramural grants, this would be an enormous undertaking, even if it was limited to just diagnostics, because there’s a lot of information. I mean, we could do it, but I think my first question is, “Is there a time line that we’re looking at when we’re putting this together? So is it going to be graph funded on this topic in the last five years or 10 years?”
Lise Nigrovic: Right. That’s a great question.
John Aucott: You know, the general thinking from our end is it would be one or two years, not 20 years. Exactly. Because we’re aware that this is a big lift, so probably one year.
Maliha Illias: Okay. Perfect; because I know that the document also captures another part which is if HHS agencies have any reports that capture a lot of the information that this document is trying to get at and for example, for NIID, we have a Lyme disease research report that’s available online and we... It was put up in 2016 and so it captures most of the highlights of our research up to that point and we keep updating it every year and so I think the 2017 version is now on the website. So, a lot of our information can be garnered from those type of reports and the presentation and the working group meeting seems to indicate that that would be a good way for us to get our information in a nice summary form.
Lise Nigrovic: I guess we would have to map that to this form. I agree, it’s fairly broad and there may be, you know, grants and extramural efforts that sort of cross programs or cover many different areas or maybe hard to categorize. Did your question also have the time frame of completion as part of the question?
Maliha Illias: No, no; just what...how the different times are covered.
Lise Nigrovic: Different times... Yeah. Yeah. It looks like its FY17, 18, and then some future prognostication in terms of the size of the profile. I mean it doesn’t break, I mean it would be nice to attach some dollar amount to the types of research...the categories of research effort, but that may be very hard to do.
Maliha Illias: This is Mahila, again. So I think it can be done. A lot of the information...
Lise Nigrovic: Yes.
Maliha Illias: ...for awarded grants is online in the NIH reporter and we can also get it from our appropriate offices. It would take a little bit longer, but we could get that. I mean, again, if we know how narrow we want to focus in on it will just make getting all of this information easier.
Lise Nigrovic: Uh huh. *** (indistinct - 00:24:31.) I just wondered if anyone has any, understanding of like how this forum came to be. Is it based on work in other areas or how was that... How was it created, all these different categories?
John Aucott: So, I can speak to that. It was based on previous inventories that had been done for other programs and it was generated, you know, by the Offices of the DFO, with some input from the chair and co-chair.
Lise Nigrovic: Okay. Great.
Steve Schuster: Steve here. This is for you, John and Lise. So, what... You know, it’s going to help to define what’s the purpose of this information, and so, we prioritize our work effort? You know, is it really to...just facts or do we want to carry this forward to say, “what’s really the gap in the area of testing or gap or things that are working that should be promoted rather than just details of how much funding has been there?” Because we’re not really necessarily making our use of our expertise’s physician, scientist, or, you know, people have disease versus an economist maybe. So, but maybe that’s... That would help to clarify that.
John Aucott: So, it’s really to provide a summary of what activities are going on. So, you know, if your group is, you know, interested in the role of molecular diagnostics and you see that there’s no programs for molecular diagnostics—you know, I’m just making a hypothetical—then that would be important. If you’re interested in the immuno-diagnostics and there’s no work there that would... You know, so it’s to let you look for the gaps that are of interest to you not gaps that aren’t of interest to you.
Steve Schuster: Okay. So, in other words some of us may say, “Hey, I’m interested in this,” and then others who have access to what dollars or grants have been spent or active or something, then you in the—for lack of a better term—the steering committee/working committee, then you’re going to put it together?
John Aucott: We’re going to take the input from all you guys today and polish and maybe delete some stuff and maybe add some stuff to this draft inventory. One point I make is, you know, you obviously don’t even know the scope of what you’re...you as a group have decided you want to look at. So I realize that, you know, you haven’t discussed what five particulars of diagnostic and testing you’re going to focus on, because you haven’t had a chance to discuss that and that’s really what you’ll probably be discussing at your first meeting. So, you will obviously can’t, you know, address all the aspects of diagnosis and testing. You’re going to have to pick what you think are the priorities where there’s the most opportunity and the most bang for the buck, and so, it is a little unfair to ask you to comment on the inventory when you’re not exactly sure what you’re going to be focusing on yet.
Steve Schuster: Okay. That’s a fair statement.
Noel Aurel: Hi. This is Noel.
Female: Hi...
Noel Aurel: The one thing... Oh, I’m sorry. Go ahead.
John Aucott: Go ahead, Noel.
Noel Aurel: Okay, yeah. So, the one thing I was noticing, you know, there isn’t a separate box for anything regulatory related. It’s not clear in the mission, since there is a box for “other” and that could be put in. And so, even looking broader than just our diagnostic subcommittee, you know, if there’s a committee that’s going to be working on vaccines or there’s a committee that’s going to be working on other therapeutics. When you’re looking at what FDA does, you know, there’s going to be contributions in each of those areas that are not necessarily basic research or epidemiology or additional education. So, that’s one thing that seems to be missing, but like I said, since we do have the option for checking “other” I’m not sure that that’s a very big deal.
John Aucott: Okay.
Lise Nigrovic: Will the survey capture regulatory efforts of the government? (Silence.) I’m just uncertain about that process. Is that going to be attempted to be captured?
John Aucott: I believe so. I mean it’s really... Yes.
Lise Nigrovic: It’s supposed to be all-encompassing. Yeah. I mean I agree it’s sort of...
Noel Aurel: I mean, if it’s not, then we’ll make the FDA contribution a lot shorter. So...
(Laughter.)
Noel Aurel: ...I don’t want to talk into it that much.
John Aucott: Yeah, I believe...
Lise Nigrovic: There’s a certain element to capture. It may be your point about being a little bit more explicit about that, is a really good one; not just leaving it as “other,” but making its category. So I would take that suggestion back. Not to create work for you, but just to be a little bit more specific.
Deborah Hoadley: This is Deb Hoadley. I have a question about whether to add a word in another spot. Can you hear me okay?
Lise Nigrovic: Yeah.
Deborah Hoadley: Okay. Did you want me to go ahead and talk about this? I wasn’t sure if you were still discussing the last topic.
Lise Nigrovic: No. Where would you like to add a word?
Deborah Hoadley: Uh, I don’t know whether you want to do this. Every time it says “other tick-borne diseases;” for example it says, “Check a box for each of the tick-borne diseases at *** (indistinct - 00:30:42,)” and that occurs several times throughout the form; do we want to add, “Other tick-borne diseases and associated conditions?” Just having heard the public comments about Alpha-Gal and there are people working on post-Lyme methods for dealing with chronic inflammation. There are other things that aren’t actually tick-borne infections that may or may not be related to what people are looking at, maybe not in testing and diagnostics, but in general. Do we want to write “and associate conditions” or do you want to just leave “other tick-borne diseases?”
Lise Nigrovic: I think that’s a good point to be consistent across the language. John, who will be collecting these edits?
John Aucott: We’re writing them down.
Lise Nigrovic: Okay. Great.
John Aucott: Yeah. So, you know, you’re right. I mean it’s not that Lyme disease includes post-treatment Lyme disease syndrome. You know, is it a broad term that encompasses late Lyme arthritis. You know, I guess if there is a very broad term, not as a term that covers all. But, you know, it wouldn’t be bad to explicitly call out post-treatment Lyme disease syndrome, because it’s unique in nature.
Lise Nigrovic: And it sounds like you want to...
Deborah Hoadley: I was thinking more that they... Oh, I’m sorry.
Lise Nigrovic: I was just going to add, like you want to even be—this is Lise—a little bit more general about that in terms of tick related conditions. You just wanted the opportunity to be as inclusive as possible.
Deborah Hoadley: Yes. If you separate out post-treatment Lyme disease syndrome then you will again be leaving out Alpha-Gal. So, if you just put “other tick-borne diseases and associated conditions” that will include anything that anyone is worried about that may be a *** (indistinct - 32:45) of tick-borne illness.
John Aucott: So remember, the agency has to respond to it. So, they have to know what you mean by “other,” you know, they have to know what to respond to.
Deborah Hoadley: Oh. I see.
Maliha Illias: And I think this topic came into the discussion when we were talking about the vision during the working group discussion and I liked how Ben Beard from CDC mentioned that he considered things like the red meat allergy associated with tick bites and others to also be diseases. So I mean it could sort of be considered in that category.
Lise Nigrovic: Right.
Deborah Hoadley: Okay. Yeah, to me some of these are sequela, but I guess that’s...maybe its semantics.
Lise Nigrovic: Right. We can really look at this maybe specifically with the lens of diagnosis, as well if we’re capturing anything and we may really want to think about the diagnosis as related to these other related conditions; so, important to bring up.
Deborah Hoadley: Thanks.
Lise Nigrovic: We want...
John Aucott: So Lise, you’re getting close to where the time is you’re supposed to talk about the National Town Hall Meeting and how to get public input to certain questions.
Lise Nigrovic: Sure. Well, I don’t really have any information about that except that it is going to happen...
John Aucott: Uh huh.
Lise Nigrovic: To allow additional stakeholders to give input, but I don’t have any information about a date or how one would invite presenters or be involved with that. So maybe you should go ahead if you have something...more information than I do.
John Aucott: Yep and so the question... And I’m not trying to blind side you, believe me. (Chuckle.) So, the question for the group is not those specifics, but is, you know we wanted to try to get the public input sometimes, maybe some ability to be focused on different types of questions. So, we were wondering if there were questions that you all as a group you would like to hear people comment on, you know, relative to your charge of diagnostics. You know, in other words, how would you maybe suggest we pose some questions for the public input to focus on? You know, for instance, would you like them to focus on questions about whether they got proper information about how to interpret their tests? I’m just making something up. You know, specific...some questions like that we’ve been asked to provide to the working group.
(Silence.)
John Aucott: And if there aren’t any that’s fine too.
Lise Nigrovic: Well, I think you’ve probably hit on an area, John, of both clinician and patient confusion. I’m sure there will be some input on availability of different testing and interpretation of testing. I think that would be a good idea to pose to a Town Hall Meeting in terms of delivery of information and some of that confusion which really can be quite distressing to patients and families who are... Because clinicians don’t always say the same thing as well.
John Aucott: Uh huh. And I think that’s an example of what...
Lise Nigrovic: That would be a good place for...
(Silence.)
Lise Nigrovic: You know, as we get into the meat of the discussion and really start the work of the working group, I imagine some of these questions may come up and, you know, because we haven’t had a chance to think about this or process this in the context of the work that we’re going to do, I feel like, you know, we’re probably not as... So, is this something we can come back to as the event gets closer or...
John Aucott: Absolutely. Yes. Yeah, yeah. I know and I totally get it. You know, this is a way... You know, I think you’re absolutely right. This is going to be a process. Yep.
Lise Nigrovic: Yeah. Does anyone else have thoughts right at this moment about the Town Hall Meeting or need for input?
(Silence.)
John Aucott: Okay. So Lise, if there isn’t, then the last thing... So you’ve got about... You’ve got about eight minutes left, I think, is 8 to 10 minutes left is to think about your first official meeting and there’s a couple of issues about that. One is the list of potential issues that you want to address, but then realizing that it’s probably going to be... The first meeting you’re probably going to be in a position of needing to narrow down the list. So, you might consider now just kind of a broad list of potential issues that your group might want to address. You know, maybe you could go around the room virtually and have people kind of comment on what aspect of testing and diagnosis they might think is one of the focuses the group could work on at your first meeting.
Lise Nigrovic: That sounds like a great idea. I think what we heard from Richard is we have a tight time line for our initial recommendations, meaning this is work we’ll be doing over the spring months and our product is going to be some sort of report that’s going to focus on 3 to 5 priority issues, perhaps closer to three and really advocate strongly for them. But we’ll see how the numbers flush out and I think these... In my mind in thinking about this, they could fall sort of in the general categories of sort of a needs assessment gap analysis and sort of an ask for what we want to do or to how to improve the current situation. So, why don’t we start by taking input from the group on general topic areas and we can kind of... I’ll keep a list and we can come back to them when we meet again. (Pause.) Any volunteers for just any sort of general categories that we could discuss?
(Several people speaking at once - 00:39: 35.)
Noel Aurel: I... Go ahead.
Deborah Hoadley: Sorry. I’m not sure. Should you ask each of us by name?
Lise Nigrovic: Sure. That might avoid... So I missed the first introduction, so is Roberta on the phone and maybe she would have some suggestions? I’m going alphabetically.
(Silence.)
Lise Nigrovic: Noel.
Noel Aurel: So the question is to start to get some ideas of the 3 to 5 priorities that our group would focus on in the realm of improving testing and diagnostics?
Lise Nigrovic: Yes.
Noel Aurel: Hmm.
Lise Nigrovic: So, you know, I might throw one out there, like improved accuracy of testing, like I think would be an area that we could discuss. That’s mine. That kind of thing that there’s well recognized limitations in the current approach and I’m sure we all share the desire to look at improved diagnostic strategies.
David Roth: Can I jump in and start just from a patient perspective, you know, because I’m the only one on this...
Lise Nigrovic: Of course.
David Roth: ...who’s coming as a...somebody who’s lived through it. Well, maybe there’s others on this call that lived through it, but as a patient and as an advocate for patients and, you know, to me the diagnostics is a mess and there’s a whole variety of challenges that you face. I can give you the list that I sort of think about, you know, the issues of the current diagnostic regime. Uh, so the first is the issue of seronegativity. So, this is things like, you know, what happens when you use antibiotics? Does that create a certain seronegative situation? It’s not really seronegative, I guess, but early... The issues that we can all agree on that with serology tests, you know, early diagnosis is critical, but impossible, because of lack of sort of the reactivity of the immune system at that point. A question that often gets raised is the multiple species problem, you know that this is a current diagnostic regime that’s based on very limited numbers of species and there’s a sort of a heuristic challenge I guess, which is if you’re a patient and you get bit by a tick and it turns out its meomotoi (sp?) which doesn’t show up on the quote unquote Lyme diagnostic test. It’s kind of cold comfort that you’ve got meomotoi. (sp?) So there’s this issue of just like sort of multiple species and how do we deal with that? The issue of, you know, immuno-suppressed individuals, lack of... And then another broad category, lack of precision. Right, lack of sort of... I can’t tell you how many tests I had and everyone was different. Some were positive. Some were negative. Some were indeterminate. So there’s no sort of ability to feel comfortable that the tests are going to be same over and over again. Lack of timely info, the chronic symptomology, whether it’s putting aside the question of chronic infection versus immunological reasons. There’s no real test that allows us to sort of deal with that chronic patient and of course, you know, an IGG response could be from an earlier infection. So, you have multiple infection problems as well. The subjectivity of the test is another area of problems, I think. The question of the criteria which is sort of the use of five bands in IGG; is that good for national reporting reasons, but terrible for clinical diagnosis. I can tell you that’s what the patient population believes, but that’s an issue that I think needs to be thought of; a lack of understanding. You know, this is sort of not just an issue of the technology, it’s also an issue of the way doctors are treating the technology and this goes to sort of what Virginia did where they said, “many doctors are out there that don’t even know that these tests, you know, when they come back negative, don’t necessarily mean that they’re...that the patient is not a Lyme patient.” I think, Lise, this is something you have interest in in the fact that these tests were never really tested on children versus adults.
Lise Nigrovic: Yep.
David Roth: And the serology not being able to tell us when a patient is better just by way of examples. I probably could come up with some more, but that’s how I think about it. And obviously...
Lise Nigrovic: I think that’s fabulous.
David Roth: ...other tick-borne infections generally that are even worse than the Lyme disease diagnostics, I think.
Lise Nigrovic: Yeah and I...
David Roth: So my question would... Yeah, my question with this group is given the timetable of this report, how do we sort of... How do we prioritize to make sure that we truly add value and don’t end up going in too many different directions? And my suggestion would be, in a sense, that in this time frame I would just ask the question, “Do we have the ability to do more than bring data to the table that, you know, in my opinion, debunks some of the myths of the current regime as it’s viewed by the medical community?”
Lise Nigrovic: Well, I think... Thank you. Those were great suggestion in terms of topics. I think you...they fell in the general buckets of limitations to current diagnostic strategies to use a special population and sort of clinician and patient education and I think those are all well recognized gaps and I have written some notes on your great points. I think we can really dig into what we can do in our committee next week. I’m sure John’s going to say we’re almost out of time, so... But I think it’s really important and I think in some ways getting together these limitations, these gaps, figuring out on what we can do to improve on these gaps and asking for resources that we need to close the gaps are probably going to be what we...our approach that we’re going to need to take and we’re going to need to pick 3 to 5 areas that we really want to hammer in on given limited time and resources would be my take on that and I think those are great places to start. So, other people who have ideas to add and I think, you know, it’s sort of opening a big conversation right at the end of a call, but we will plan to get together.
Steve Schuster: Right.
Deborah Hoadley: Those are such... I’m sorry. Go ahead.
Steve Schuster: No. I’m just saying, I think one thing we have to do to save a lot of time and it probably would work for the other groups too, is definitions of what we’re talking about. You know, what do we mean by accuracy? What do we mean by gap? What do we mean by window? What do we mean by a battery of tests? I think if we don’t go... Then otherwise we’re going to keep either redefining it or arguing. But there are certain things that we should be talking at. You know, like it’s not just precision or accuracy. We really should define what we mean by that and that will help us move forward much more quickly. It’s boring, but I think it’s something that has to be done.
Lise Nigrovic: Uh huh. Okay.
Deborah Hoadley: And also, I was just thinking that, how do people feel about having an email discussion group where you could think a little bit about what strategy might work and verbalize it in an email and have discussions in a little more depth that we’re not able to do on a conference call before our next meeting? Is that something that we could do?
Lise Nigrovic: I defer to the federal agent, the method *** (indistinct - 00:48:23) person, but...
John Aucott: So Jim says, “Yes.” Again, you can do that. You’re not calling a meeting. Yeah, so yes, you can do that.
Lise Nigrovic: Okay and I think in terms of the practical next steps and I thank all of you for finding the time to be together this afternoon on such short notice. I think it probably will help to have a standing time; although, if somebody has a conflict we may have to do some rotation. I would like my federal co-chair to be identified as we start down this journey just so we can start at the same place and I don’t have a sense of that time line. So hopefully that’s, you know, days to weeks for that process, but we should get a time on the calendar where we can...you know save the time, because I know everyone is busy and your schedules get filled up.
David Roth: I also just want to apologize in advance. Obviously this appointment came very recently. I have a ten day period starting tomorrow where I’m going to be totally out of pocket, just impossible to get in touch with.
Lise Nigrovic: Okay. Of course, I think... You know, over the course of the months everyone is going to have conflicts and so we appreciate everyone’s great efforts to be a part of it when you can, but email is a good substitute, I guess, so you can catch up when you get back.
Jim Berger: Lise, this Jim. If you want we can set up a doodle poll with your members if you want to give us some times that you would like to meet, we’ll certainly go forward with that.
Lise Nigrovic: Sure. Do we have a time line on the co-chair assignment? Like could we... Maybe if that takes another week then we should do it the week after that or something?
Jim Berger: Right. We don’t... We do not have a time line at this... We’re aggressively pursuing it, but we don’t have a time line identified.
Lise Nigrovic: Okay. So I’m thinking the very beginning of March. (Chuckle.) Give things a little bit of time and then we can start...
Steve Schuster: Steve here again. You know, I think we’re wasting a lot of time like by waiting and waiting and waiting. So if we can, what could be done is we could arrive at certain topics like right away, you know, like top three and then divide the group informally. You know, like we can choose who wants to work on what with who and then they can come back when, in two weeks or something like that. This way we’ll speed things up so we’re not just marching in place. (Pause.) Does that work for people? (Pause.) Well, Lise, the balls in your court, because you’re the only chair.
Lise Nigrovic: Yeah. Well, it’s all a team journey. I do think having the co-chair assigned is probably going to be helpful. I’m also on vacation next week. So I think I will be contributing as well to my, you know, either... You know, it seems like it would be too quick to get this established at the end of the week and I very much value meeting time and I think meetings without a clear purpose are... You know, so sometimes it’s better to kind of get things straightened out. But I do see the clock ticking. So let’s starts a doodle poll. I’ll try to get some more information about when we may have that co-chair. I would not be available next week.
John Aucott: Okay. Thank you, Lise. We’ll get together with you later tomorrow or Wednesday to get some more details. All right, so we’re going to have to close the meeting. Lise, are you comfortable presenting this to the total working group in the next session?
Lise Nigrovic: Uh, sure. You can join in, but sure.
John Aucott: Okay.
Lise Nigrovic: I missed the first part, but yes.
John Aucott: So this would end the call now and people should now transition back to the total working group call which will include the Adobe Connect portion in the rest of the call. Thank you.
(End of Breakout Session 3 - 00:52:33.)
Breakout Session 4
Access to Care Services and Support to Patients Subcommittee
Karen Vanderhoof-Forschner: Who else is here in the room?
Leonard Schuchman: Yeah. Hi, Karen. I’m here.
Karen Vanderhoof-Forschner: Len, hi.
Anna Frost: Hi, this is Anna Frost.
Holiday Goodreau: Hi, Karen. It’s Holiday Goodreau. I’m here too.
Karen Vanderhoof-Forschner: Hi. How nice to talk to you, Holiday, uh, Sue Grain is doing judge work today so she can’t attend. Ana Frost, are you here?
Ana Frost: Ana Frost is here.
Karen Vanderhoof-Forschner: Oh, Ana. Hi. Is Enid here? (Silence.) Okay. Paula Jackson Jones. Paula Jackson Jones, are you here? (Silence.) Colonel Nicole.
Nicole Malachowski: Yes, I’m here and like you, I cannot access the room.
Karen Vanderhoof-Forschner: Okay. (Chuckle.) Uh, Coop, are you still here?
Scott Cooper: Uh, yes. I’m here. I’m actually in the room and I’m marking down... I’ve got our list of subcommittee members and I’m marking who’s present. So, so far, I have... Let me just run through. I have Ana Frost, Holiday Goodreau, Col. Nicole Malachowski, Dr. Leonard Schuchman, and Sheila M. Statlender. Is that correct? Anybody I missed?
Karen Vanderhoof-Forschner: Is Kathleen Steele here? (Silence.) Okay. That’s fine and Sue Grain is not here I don’t think, right?
Scott Cooper: And how about...
Karen Vanderhoof-Forschner: Yeah, she’s not here.
Scott Cooper: How about Enid Haller?
(Several people speaking at once - 00:01:37.)
Kathleen Steele: I just had you on mute. Kathleen Steele is here. I just had you on mute.
Scott Cooper: Okay. Thank you, Kathleen.
Karen Vanderhoof-Forschner: Okay.
Miguel Gomez: And Scott, I don’t know if you can hear me, this is Miguel Gomez from OADP (indistinct - 00:01:45) as the Office participant.
Scott Cooper: Okay. Great, Miguel. Thank you.
Karen Vanderhoof-Forschner: Thank you. Can you tell Jennifer, Coop, that I can’t get in. I’ve tried a couple of times.
Operator: Yeah. I’m here. So, what you will need to do is you’re going to have to close your window that had the main webinar. Just save the link.
Karen Vanderhoof-Forschner: Save the link. Okay. I don’t know how to do that. You know I could...
Operator: Okay. So, let me send it to you. Do you have your email on?
Karen Vanderhoof-Forschner: Yeah. Send me the link. My email is [email protected].
Operator: So, I’m going to send this to you through your email. Go to Adobe Connect in Windows and then when you get this link just click on it and you’re going to have to enter as a guest.
Karen Vanderhoof-Forschner: I’m going to have to enter as a guest? That’s fine.
Operator: Yes.
Karen Vanderhoof-Forschner: In the meantime, I’d like to say, thank you and Coop, you’ll have to take over in a minute. I’d like to say, thank you to everybody for participating. You’re all so highly qualified and I am amazed that I’m lucky enough...we are lucky enough to have you on this subcommittee. Coop, do you want to say something?
Scott Cooper: Uh, yeah. I just want to echo that, Karen, and thank you all for taking time to do this. As Rich pointed out earlier, this is totally new. We’ve never done anything like this. This is... They’re finding, you know, this advisory committee is... It’s a lot. It takes a lot for them to organize. It takes a lot of energy and work, so again, we really do appreciate you and I just wanted to ask, for those who are actually in the room, do we want to use the WebCam for this so we could see each other? Or what’s the feeling or just leave it optional?
Karen Vanderhoof-Forschner: I think everybody has what I typed up as a tentative agenda which covers the same thing as the WebCam, I mean the web stuff, and I haven’t gotten the hyperlink yet; so, I’d say let’s just... Is that okay? You have the tentative agenda?
Scott Cooper: One sec. Did you... When did you send that, Karen? Let me check back here.
Karen Vanderhoof-Forschner: Last night at 2 a.m., right before I got the slides.
Scott Cooper: Okay. Let me take a look.
Karen Vanderhoof-Forschner: I apologize for the confusion.
Scott Cooper: I don’t know if I got that. I’m not seeing it,...
Karen Vanderhoof-Forschner: Well, I can work without having the link. I still haven’t gotten anything coming through. But the first thing on the agenda I think they really want is a discussion of the Request for Information from the DOD.
Scott Cooper: Okay. Karen, could you send me the agenda so I have that in front of me?
Karen Vanderhoof-Forschner: Yes, I can.
Scott Cooper: Thank you.
Karen Vanderhoof-Forschner: Oh, there’s Richard. I have him on my WebCam. Okay.
Sheila Statlender: I can see Richard on the WebCam. This is Sheila, but I...and I can...
Operator: No. Rich is in the main out-room. You should not be looking at that one. There’s another web window that is open that is for your subcommittee.
Sheila Statlender: Right, but I’m not able to access it. And I’ve been trying to ask for help online, but nobody’s responding.
Operator: Yeah. If you... What is your name?
Sheila Statlender: I’m Sheila Statlender.
Operator: Okay and what we also need is for you guys, if you are... If you have your laptop, we need you to mute your speakers, because it’s creating the feedback.
(Pause.)
Sheila Statlender: (Speaking to someone in their private room.) Oh, I left the door open. Actually, he can be... As long as we watch him, he’s okay. If you could put that so he can’t get up the stairs.
Operator: And so, we can also have feedback. If you’re not speaking, it’s probably a good idea to go ahead and mute your line and then just un-mute when you want to speak so we don’t have the feedback.
Karen Vanderhoof-Forschner: Coop is on his way.
Miguel Gomez: And Scott and Karen, if you just... It’s Miguel, even though you don’t have the agenda on the screen, I’m sure someone could share what the first agenda item is. I’m just worried about your time. If you’d like to start now and other people can get some...as they wait for their technical help.
Scott Cooper: Okay. Go ahead Karen. If you want to go ahead since you’ve probably got it right in front of you.
Karen Vanderhoof-Forschner: I’ll go ahead. Okay, let’s first talk about the inventory for the tick-borne disease project and activities. You all got a copy of what’s being sent in? Is this correct? (Silence.) Am I even connected to the group?
Anna Frost: Yes. We got a copy of the DOD report. This is Anna Frost.
Karen Vanderhoof-Forschner: Oh, Ana. Thank you. And so, I made some changes to that that I wanted to know on the first page that you have...
Sheila Statlender: This is Sheila. I think I just got in. I closed the main window and just opened the...clicked on the link and I was able to... I now see the PowerPoint, “tick-borne disease working group access to care services.” Does that sound right?
Karen Vanderhoof-Forschner: Yes, and I am also in and I’m able to move the slides back and forth and it has a slightly different feel to it then the agenda I just did, so we’ll adjust. So first tell us about yourself. I’ll tell you about me and then Scott will and then I’d like each of you to quickly say something about yourselves. I’m Karen Vanderhoof-Forschner. I’ve been in Lyme for 30 years, most of my life, and my son had Lyme. You probably know the story or heard about it and he was infected by me while I was pregnant. It was difficult to get him diagnosed and treated. His main problems were nerve conduction delays and cranial nerve involvement that affected his ability to use his tongue and swallow; his ability to... His eyes had tremors. He had facial palsy and he had other issues with Lyme disease that he got from me and when he died at six years old, the first thing I did was call up and dole out body parts and they found Borrelia Burgdorferi in his optic nerve. So, despite long-term treatment he was still infected and so it showed, to me at least, that we need a better treatment protocol and faster treatment, because it took us until he was about five to really get it nailed down, because of doctors, denials, and insurance company denials and controversy and the CDC protocol and just about everything and the cost of course; we had like 2 million in medical bills by the time he was six. So, that’s my background. Coop, do you want to go?
Scott Cooper: Sure. Thanks. Thanks, Karen. And you probably, some of the stuff out there, particularly on the website for OASH and this group has my biography, but I’m a physician assistant by training. I’ve been one for over 20 years. Over 17 years as an active duty public health service officer and varied clinical experiences, different settings, hospitals, correctional facilities, and for the last over 10 years, maybe, 14 years now I’ve been the Lead Officer and Senior Technical Advisor at the Centers for Medicare and Medicaid Services for Hospital Regulations. None of the insurance payment regulations... This is all the health and safety regulations for patients for hospitals and critical access hospitals and other providers that we do. A lot of people don’t realize that Medicare is a national regulator on those issues and we kind of... We set the standard there that the Joint Commission can then expand on and some of the other accreditation organizations. I don’t really have much of a Lyme or tick-borne disease background at all, which may be good, because I kind of come to this fresh and without any of the history really or anything that goes with that. So, I’m kind of looking at things with fresh eyes and I’m very open and that’s it for me, other than, yeah, my only thing is three dogs over the last 20 years that I’ve vaccinated every year and that’s about it and one patient a long time ago who was actually a nurse who was admitted with Lyme. Uh, this is going back to the early 2000s and that’s it for me. So, I guess we can work our way down. Is it all right if I kind of callout each person going by what we had here or the list that I was going through? Let’s start with Dr. Frost, Ana Frost and by the way, Coop is fine. Scott is fine for me. We’re trying to keep things informal in the working group and also in the subcommittee. So, Ana Frost, or if you prefer Ana or Ana, if you could introduce yourself.
Anna Frost: I go by Ana. It’s kind of weird for...to be called Ana Frost, even though that is my title, but yeah. My name is Ana Frost and I have a PhD in leadership studies from Gonzaga University in Spokane, Washington. In 2016, I finished my dissertation on Lyme disease and there’s a lot of questions that are probably stirring as far as, “What is the connection between leadership and Lyme disease?” I’m not going to get into that right now, but I will say what I did was I completed a six-month qualitative study on five Lyme sufferers in the Pacific Northwest and I learned essentially how they recover from Lyme disease, what their experiences, their story. I interviewed their friends and family, their doctors. I observed them in many different contexts that were meaningful to them and so forth. And so, I ended up writing a 600 page dissertation which because really there’s not... There really isn’t a lot of qualitative research out there about Lyme disease and so it’s pretty extensive. It’s on my website for free, because I think research should be made available. So, if you’re interested, You can go to Dr. Ana Frost.com, but... Currently I work for a health career organization, but I don’t represent them on this committee at this time. I... How long I have been involved with tick-borne disease: so, I am a patient myself or was a patient myself. I got sick in 2004 and it was very serious, very obvious something was wrong, because I was partially paralyzed and it turned out to be Lyme disease and... Long story short, I went into remission four years and a day after I got sick and have been involved with Lyme advocacy since 2004, really. I’m sorry, 2006. So, it’s been 11 or 12 years now almost. So, yeah. So, I’m really passionate about...particularly about patient advocacy and empowerment and access to issues and I look forward to seeing what we can...what emerges from this group. Thank you.
Scott Cooper: Okay. Thank you. Thank you, Ana. Next, Ms. Holiday Goodreau.
Holiday Goodreau: Hi, this is Holiday and I am the president and executive director of the LivLyme Foundation that was started by my 13-year-old daughter, Olivia, who spoke at your HHS first meeting and told her story of how it took us 51 doctors for her to be properly diagnosed, over 18 months, which I know in the Lyme world is very fast, but it almost killed me off and she was misdiagnosed on multiple occasions - told she was making it up. Again, had all sorts of presenting symptoms of Lyme disease, but it was our 51st doctor who finally figured out. With that being said, figuring it out, it still took us about three more years to realize that she had five other co-infections with this one tick bite. From that now has POT syndrome. Her blood is a mess and she’s having liver issues. So, she gets IVIG every three weeks, but she decided to start this foundation when we started meeting kids with...who had Lyme disease and their families and we just realized how many families could not afford to take care of their children. And so, in this last year she’s raised $340,000. We’ve given 11 grants to families from all of the country with Lyme disease. We’ve had 56 families apply from 22 different states asking for funding. She gave three grants to top Lyme scientists from Dr. Zhang from John Hopkins, Dr. Sapi from New Haven, and Dr. Rajadas from Stanford. We hope this next year to be giving more grants to children and to scientists. She has a big announcement in the next 10 days that I hope...that we hope will kind of change...make a better change in the world for people with tick-borne diseases. So, we’re excited to share that with all of you and I just personally want to say how thrilled I am that I am on this subcommittee, that HHS is doing this, and I just really look forward to working with all of you. So, thank you.
Scott Cooper: Uh, thank you, Holiday. I just... I know Susan Greene is not here. She had a conflict, but I just wanted to make sure that Dr. Enid Haller is not on the line.
Enid Haller: Yes. I’m here.
Scott Cooper: Oh, okay. Great. Thank you.
Enid Haller: Yeah, I’m sorry... That’s okay. Thank you. I’m sorry I could not... I cannot see any of the slides or I’m having trouble connecting with the Adobe for some reason, but I can hear everybody and they helped me connect with you guys. I was connected to the wrong group for a while, (chuckle) but they helped me. I was talking to John Aucott and Christine for a while. (Laughter.)
Karen Vanderhoof-Forschner: You know what I’ll do is I’ll tell you what’s on the slide. This is the first slide and it says, “Introductions. Tell us about yourself: name, title, affiliation, how long have you been involved with tick-borne diseases.” There. You’re up-to-date.
Enid Haller: Thank you, so much. Okay. So, yes. I’m Dr. Enid Haller. I have a Masters in social work and a doctorate in clinical psychology. I am from Martha’s Vineyard. I have lived there for about 11 years and I was diagnosed by Dr. Richard Horowitz with Lyme about nine and a half years ago, as well as my husband and my daughter. So, we realized there was a problem in Martha’s Vineyard, because the local librarian was asking me for help, so I... They hurried me to - they said a lot of people were coming in there to the library with Lyme disease and nobody was getting the help they needed. So, they encouraged me to start a Lyme support group, which I did, and I’ve been running that for about 10 years now and a monthly support group and, you know, everybody just started coming out of the woodwork on Martha’s Vineyard, very bad for ticks there. Some areas you really walk into, you’re covered with 100 ticks. It’s very, very bad there. So, many people are infected and don’t know what to do. So, with the Lyme support group... Just to let you know, I have a mailing list of about 859 names are on the mailing list now. So, there’s been more people than that, actually. I haven’t even counted the emails themselves, but a lot of people. So, I started the Lyme Center about five years ago, because a lot of people were too sick to actually get to the support group and so I was able to individually help each person better that way and connecting them to Lyme literate doctors was the first step, of course. Introducing the IGeneX was very helpful. It was a big fight with the community and boards of health and the hospital and very difficult, not very much help from everyone...just from the alternative practitioners, but I was able to get the IGeneX in there and, uh, so people at least can have a better test and then, you know, we’ve been trying to figure out how to help people that cannot afford treatment with the Lyme literate doctors in the area. We do not have an LLMD on the island and it’s difficult for people to travel there, because they’re so sick. But we’ve had quite the uphill battle. I’m very proud to be a part of this working group. It’s about time and I’m so happy. I have great hopes that we’ll be able to make a difference. Thank you.
Scott Cooper: Uh, thank you, Enid and next, Ms. Paula Jackson Jones.
Karen Vanderhoof-Forschner: Jackson Jones. Her last name is Jones.
Scott Cooper: Oh, okay. I’m sorry.
Karen Vanderhoof-Forschner: It’s backwards on that one sheet.
Scott Cooper: I will change that on here.
Karen Vanderhoof-Forschner: Thank you.
Scott Cooper: Okay.
Paula Jackson Jones: Thank you. Yes. I’m Paula Jackson Jones and I am the president and cofounder of Midcoast Lyme Disease Support and Education. I co-founded this organization in 2014 when I went into remission from my own battle with like stage neurological Lyme and four co-infections that were misdiagnosed. My battle is very familiar with a lot of other people’s battle. It was a short battle, but it was an intense battle. At my worst I was in a wheelchair. They were considering ALS and I was uncommunicative and I came out of that when I finally got connected to my Lyme provider which was doctor number 24 and with her team recognized that it was neurological symptoms. They treated me. I was in treatment for quite a few years and I came out of it. So, I co-founded this organization with another friend of mine who I was introduced when I went into remission and I use that word remission. One of the things that we do, we started off running support groups. We run five active support groups around the mid-coast region of Maine and we support a lot of the grassroots groups throughout the rest of the state of Maine. We quickly discovered that we had to wear multiple hats. We realized supporting the patient and their access to care was one step. The other hurdle was getting physicians up to speed. So, one of the things that we do is we travel all around the state of Maine hosting workgroups and educational events. We do workshops for providers bringing in experts to train them peer-to-peer. We host a lot of educational events doing prevention talks, how not to get bit by a tick, and then one of our biggest things is we are networked heavily with over 200 doctors in the state of Maine. Not all are ILADS trained, but all are what we would consider Lyme literate or Lyme friendly and they’re willing to work with other providers. So, when a patient in Maine is looking to get connected, they can reach out to us. We can get them connected. If a doctor has a patient and they have kind of run through their toolbox and they don’t have anything else, they will reach out to us and ask who near them can they refer them to or who can they network with or who can they shadow with to learn more. We are also the main partner of the National LDA. We’ve been invited to be part of Maine’s CDC Vector-Board Workgroup which is our state health department. Just to make it clear, I bring the voice of the patient to the table and I’m always concerned about what the state of Maine is doing and how it impacts or what they’re not doing and how it impacts patients and then just this year alone... Well, I’m actually coming up on my one-year anniversary of writing columns in Maine newspapers and having that platform and that venue. I also write a column for Sportsman Alliance of Maine which goes out to over 10,000 sportsman people and *** (indistinct - 00:25:07.) So, our focus as an organization is two-part: one, how can we get the patient to the doctor who can help them and how can we help support their financial needs? We do fundraisers so that we can help people financially and the other part is educating through prevention and educating the providers as well. So, it’s a great honor for me to be a part of this team. I feel like I’m the least qualified to be on here, but again, I’m very honored to be a part of this group and hopefully to prove myself here. So, thank you.
Scott Cooper: Well, thank you, Paula.
Karen Vanderhoof-Forschner: You are one busy woman, just like all of them. It’s amazing. Thank God for moms.
(Chuckle.)
Karen Vanderhoof-Forschner: And other people - and other people, Coop.
Scott Cooper: Okay. Thank you. No and it’s good to have you Paula. Thank you. Next step we have Col. Nicole Malachowski. Nicole.
Nicole Malachowski: Hey. How are you doing? I want to thank Karen and Coop, obviously for your leadership and echo what everyone else has said, it’s really an honor and a privilege to be amongst such an extraordinary group of real warriors, you know, and courageous people and I’m just honored to be here. I appreciate you calling me Colonel. It’s important to note though that 45 days ago I was medically retired from the United States Air Force after 21 years and seven months of service as a fighter pilot. I had served in three operational fighter squadrons flown in combat. I had flown with the Air Force Thunderbirds as well. Importantly, I had been policy work during two separate assignments to the White House and a third assignment at the Office of the Secretary of Defense. My story begins in 2012, when I presented to my doctor in the military with a rash on my hip where I was told that we don’t have Lyme disease in North Carolina. At the time I was the Commander of an F-15E fighter squadron. I was at the top of my game and I was in pristine health, as you all know. Immediately within three months I started to fall very ill with multi systemic symptoms. Long story short, it would be 1,525 days, 24 plus doctors across eight specialties, as well as three misdiagnoses, when last August of 2016, I woke up locked in, because the infection had attacked my brainstem, in particular the blunt (indistinct - 00:27:25) of my brainstem. Long story short, the Air Force sent me up to the Dean Center for Tick-Borne Illness Boston, Harvard Medical School Teaching Hospital who diagnosed me with Neuroborreliosis, Anaplasma, as well as the *** (indistinct - 00:27:41.) I, anyways, was medically retired...
Male: Connie, one quick question.
Nicole Malachowski: ...mission. I’m immensely...
Scott Cooper: Excuse me, Nicole. Let me,... I don’t think that’s your background. Is there somebody who is not on mute here? If you could mute your line; we’re getting a lot of background noise.
Karen Vanderhoof-Forschner: Much better.
Scott Cooper: Okay. Thank you. Go ahead Nicole. Sorry for the interruption.
Nicole Malachowski: I’m immensely interested, obviously, from a patient perspective, but I can tell you that the knowledge across the Department of Defense as well as the Department of Veterans Affairs is abysmal as far as tick-borne diseases. If you’re lucky you’ll get a test for Borrelia Burgdorfi, but that’s about it. I’ve suffered from relapsing fever, Borrelia hermsii, plus the other co-infections. There’s absolutely no knowledge or awareness and this concerns me, because we’re talking about our service members, veterans, as well as our military families moving every 2 to 3 years all around the world, being exposed to multiple strains of Borrelia. I’d like to put special emphasis on Bartonella and the unique strains found in the sand fleas and sand flies of Iraq and Afghanistan. I like to talk a lot to my friends over the fence about what I call the other TBI, not traumatic brain injury, but tick-borne illness. That is my platform and I am continuing to have meetings with appropriate people, you know, to try to advocate for this. I consider it a military readiness issue. I consider it a national security issue and as tax payers of America, I hope people become disappointed that the tens of millions of dollars that we’re spent on me and my training were flushed down the toilet, because basically there’s no knowledge of the complexity and the breadth of tick-borne illnesses, of the testing that stinks, and obviously the recognition and diagnosis of it. So, I am retired at age 43 and this is my new mission. So, it’s a joy to join all of you.
Karen Vanderhoof-Forschner: So, we will put the Department of Veterans Affairs on the list where we’re going to ask for information and with Ana Frost we’re going to put the Bureau of Indian Affairs on there, too.
Nicole Malachowski: I think that’s an extraordinary idea, Karen, to include the VA. As you know, they have the largest Alzheimer’s and brain inventory in the world. They also have a gigantic serum repository. So, there’s a lot of opportunity here for VA to take a leadership role if they’re told to.
Karen Vanderhoof-Forschner: Who’s talking? That’s brilliant.
Nicole Malachowski: That was Nicole.
Karen Vanderhoof-Forschner: Oh, okay.
Scott Cooper: That was Nicole. Thank you and thanks for introducing yourself and it’s good to have you here and it’s good to hear from you again after meeting you in person back in December. Let’s... The next person up is Dr. Leonard Schuchman. Did I pronounce that right doctor? Is it Schuchman?
Leonard Schuchman: Leonard is fine.
Scott Cooper: Leonard is fine or Len, I know Karen calls you. Okay. Thank you.
Leonard Schuchman: Yes. I’m Len Schuchman. I’m a family practitioner. I am sort of a weirdo in the world, because you have a choice of two types of doctors. You can go to one who follows the CDC guidelines, but takes your insurance or you can go to what’s known as the Lyme literate doctor who doesn’t take your insurance.
Leonard Schuchman: Well, I will tell you that it is indeed possible, a real pain in the you know what, but I see Lyme patients and I participate with all the major insurances. The Lyme groups will tell you I’m nothing more than a CDC want and the standard doctors will tell you I’m a Lyme wack. So, I guess everybody hates me; so I must be doing something right. Just as one other... Just as one other quick introduction to me, when I told my wife that I was selected for this committee, she basically sent me an email that said, “Wait till they find out how bossy and opinionated you are. At least something will now get done.” So as I say, I think I’m coming from a side that everyone’s talking about, but I’m actually living it and dealing with it as the day by day. I’m also trying to help my patients, not only in terms of getting them treated properly, but I’m also trying to help them so that I don’t drain them of their bank account, because as I say, I am willing to work with the insurance companies. It is one nuisance, and that’s about it for now.
Karen Vanderhoof-Forschner: And let me just jump in here and just say that I’ve had 20 years of working with Len in the Lyme disease field and he is extraordinarily good and he is thorough and he listens, investigates, and you know what, he charges your average regular rate to go to him. I’m not soliciting anybody for him. I’m just saying that one of the issues that we’re going to address is, “How do we get that cost down?” because when I started going to a doc, my first payment was $1,500 for a 20 minute visit and then another $2,000 for blood tests and by then I couldn’t afford to go back. You know it’s just a barrier to access to care, whereas what Len has been doing, straddling the best he can in the world for the patients, has been a relief. So that’s my little statement there. Oh, and the other thing Coop, is I’m thinking to myself, since you don’t have a plethora of experience with Lyme, I wondered if Len might just have you come see him for a day or two with his patients; if your schedule permits, if he’s willing to do it. I’m just putting a bug in your ear, that’s all.
Scott Cooper: Okay. I will look into that.
Karen Vanderhoof-Forschner: Think about it.
Scott Cooper: I will talk to Rich and Jim. Yep. Okay. Thanks, Karen and thanks, Len. Good to have you here.
Leonard Schuchman: Can I just add...
Scott Cooper: Go ahead.
Leonard Schuchman: Could I just add one more thing just so that, you know, as we go through this, the CDC case definition for Lyme disease is for epidemiological purposes only.
Karen Vanderhoof-Forschner: I love you.
Leonard Schuchman: And in fact, now and never has been a singular valid basis for diagnosis of Lyme disease. I will challenge you to get the medical policies for each and every insurance company in the United States and find to being one that doesn’t use the CDC case definition as their diagnostic guide for Lyme disease and that is going to be actually the very first issue; whether that’s part of this committee or not, I don’t know.
Karen Vanderhoof-Forschner: Yes, it is.
Leonard Schuchman: The second issue you have...
Karen Vanderhoof-Forschner: Cause...
Leonard Schuchman: Okay. And then the second issue... The second big issue that we have is let’s be honest, we have a disease that short of a bull’s-eye rash has no clinical clues that are automatically diagnostic of the disease and you’re using a laboratory test, that is you say the surveillance. It’s not diagnostic of anything. Not to make the mention of the fact that I don’t order urinary antibody tests to try to determine whether a person has a urinary tract infection. I order a culture insensitivity to find the bacteria and define the antibiotic that will treat the infection and until such time that we actually come up with a diagnostic test that actually diagnosis this disease, we have, you know, we’re spinning our wheels and wasting our time. Unfortunately, if you look at the history of epidemiology and you look at what the United Public Health, the United States Public Health Service’s goal for the 1920s was - almost 100 years ago - they were going to grow syphilis, figure out how to treat it, and wipe it off the face of the earth and I will challenge you now to tell me, are we any closer today than we were 100 years ago to meeting that goal? And that’s actually where we are with Lyme disease and until such time we come up with a much better way to diagnose the disease and until we come up with a much better way to keep the insurance companies honest, you’re going to have a two-tiered system where you’re going to have the medical community that will tell you that Lyme disease is easily diagnosed and easily treated and then you’re going to go to Lyme literate doctors who - I’m sorry to the other people on the call who have seen Lyme literate doctors, but I’ve got to kind of question their motives.
Scott Cooper: Okay. Well, thank you. And I think, you know, we will be looking at anything that impacts access to care for patients and patient support, whether that’s insurance coverage, what that’s based on. I think that’s the beauty of this subcommittee is that we’re going to be looking at a lot of things that some of the other subcommittees are looking at from a different angle. So, with that said, let’s move on to our next...
Karen Vanderhoof-Forschner: Can I make one additional comment, Coop?
Scott Cooper: Sure. Go right ahead.
Karen Vanderhoof-Forschner: Is this disease... One of the big myths that is a bugaboo for me is that this disease was discovered 200 years ago in Europe and they diagnosed it - before we had these miracle tests that you send out to a lab - they diagnosed it by the constellation of the symptoms and it’s called the tick triad and it was meningitis and Bell’s palsy and maybe cardiac problems or joint problems. So, there was a cluster of symptoms that would lead a doc immediately to say, “Ah ha. I know what that is.” And they would treat with something or try to and they had already connected the disease that they were seeing with spirochetes, with antibiotics, and with the EM rash and the neurologic symptoms, all of this we knew long, 100 years before it was discovered in Lyme, Connecticut and so the history has been ignored and that’s one of the things I can put together, because really worked very hard with me to get the history down pat and there was this tick triad. So clinical criteria were selected so you could diagnose this disease without having these miracle lab tests and I think that’s something Len and Coop and others could put back into place. Are there other things... Which manifestation should people to think, “Oh, that could be Lyme,” short of having the bull’s-eye rash. So, let’s go on.
Scott Cooper: Okay. All right. Thank you, Karen.
Sheila Statlender: Could I ask a question of Len, too? This is Sheila. I just... I don’t want to delay things, but we would love to have more family practitioners like yourself who are open to, you know, the truth about Lyme and how to treat patients. What led you to sort of embark on treatment and to really, you know, see past the guidelines and all of the limitations?
Leonard Schuchman: The real reason, (chuckle) I live in southern New Jersey and I was commuting to New York City each day and I needed to stop the commute, because I was getting tired of it and my children were getting older and I needed to be around. So, the first position that I found was with a physician who actually was treating Lyme disease, uh, and he actually made an attempt to participate with insurance. I’m not going to go into it, because there are some other issues with him, but that’s actually how I got started. It was basically I needed a job closer to home and I’ve been... You know I’m a family practitioner now who’s had a practice that’s been seeing a lot of Lyme patients for over 20 years now.
Sheila Statlender: Okay. Okay, thanks.
Scott Cooper: Okay. Well, since you’re next up, Dr. Sheila Statlender, If you could introduce yourself.
Sheila Statlender: Sure, and I just want to echo what everybody else has said. It’s really a privilege to be on this subcommittee. I’ve been very involved on the state level and I kind of wear a lot of hats. I think it’s a reflection of how much need there is in this whole arena for, you know help for patients. I got involved initially in the late 1990s when one after the other, all three of my own children got sick. It was heartbreaking to listen to some of your stories and it’s always re-traumatizing no matter how many years have gone by. Fortunately, my kids are doing fairly well now. I also have Lyme disease myself, but I’ve been very lucky and always been able to function unlike a lot of the people that I’ve encountered in the field. Gradually as my kids got more stable and they were quite sick. We live in the Boston area. My husband is a Johns Hopkins educated medical doctor and orthopedic surgeon out of Tufts and we were fooled. We were told nobody could figure out what our kids had. All they knew was that it wasn’t Lyme disease and we went to every medical center in the Boston area, and UMASS Medical Center, and finally after our third child started to get sick we went back to the literature and the research and read for ourselves and realized what a mess the field is in and now, so what 20 years later, it’s hard to say that it’s much better in terms of the standard...the typical standards for diagnosis and treatment. So that can be discouraging, but it is wonderful to see that there’s, I think, kind of a groundswell now of people and *** (indistinct - 00:41:51) that are happening and I’m hoping that there’s going to be a sea-change, a culture change and better science. There is science, but we’re just not recognizing it where it needs to be recognized. So, gradually as my kids got more stable, I began to get involved in advocacy and education efforts here in Massachusetts. As that happened, I’ve had lots of patients calling my office for supportive counseling. So, I now do a lot of what I call “healthcare advocacy” and supportive counseling, helping patients who are dealing either with academic or workplace issues, helping to identify some of the cognitive issues that get in the way, and I’ve done a lot of...tried to do a lot of education with some colleagues who are, you know, in this arena. I’m trying to educate other mental health professionals, because I think all too often people are being referred to mental health when doctors can’t figure out what’s wrong or they’re having some sort of sequela from Lyme disease and looking like it’s neuropsychiatric and the underlying medical conditions aren’t being recognized. So, it’s a lot of work. I had the privilege here in Massachusetts of being involved in passage of Physician Protection. Now it’s a law which was necessary, because practitioners who were deviating from the recognized standard of care were placing themselves at risk from the local medical board. Here in Massachusetts the academic medical centers have a lot of influence; so even if the doctor wasn’t called before a board, there was certainly a lot of peer pressure that was discouraging them from treating more broadly. I think that we have a little bit more freedom for doctors to sort of come out from the woodwork and be more open about how they’re treating. I was sat on their Lyme commission that issued its report in 2013. It was governor appointed and we have a report that we might want to share with you. It’s much like the Virginia report that was just presented earlier. One of the recommendations that came out of that was for mandatory inference coverage for Lyme disease and tick... It was just Lyme disease and we now have an insurance law, an insurance mandate. It was quite a struggle and it took many years, but we have problems with enforcement. One of the issues is that any federally regulated plan like Medicare or like self-insured companies that come under ERISA don’t have to comply. So I’ve been, you know, pretty involved in a number of ways, never on kind of a more national basis. So, I’m really excited that the federal government may be taking notice of what’s going on and I really appreciate the work that you folks on the working group have been doing. I think that’s it. (Chuckle.)
Scott Cooper: Well, thank you, Sheila. It’s good to have you as part of this subcommittee and last but not least, we have Ms. Kathleen Steele, and I just got a note, if I can... Not to cut short your time, but if we can hold any questions for after... You know, if we can move on after this last introduction, because Kristin is reminding us we have a hard stop at 3:05. So, but please Kathleen, take your time. But we’ll hold any questions until later. Thank you.
Kathleen Steele: Okay. Well, I can talk very fast. I’m going to start with just personally how I came to be familiar with Lyme disease. I was a CEO of a nonprofit, a single mom. Everything was going wonderfully. My kids were in a great school and then my son fell ill and three months later my daughter got sick. Long story short, five years before they had a diagnosis I had to sell my house to be home with them. I was their sole person for all their social, emotional, development, their spiritual life, their education, and spent 2 ½ years unemployed spending down all the money I had gained from my house and fighting the education system to try to get them an education and trying to find medical care. So, 23 doctors later they did get diagnosed and started treatment and then I faced what it was like to try to purchase treatment for children, two sick children, trying to get child care, trying to get them educated, and trying to keep a career going, because I had to go back to work. I had spent all my house out. So, we had many years where they ate out of coolers by their beds and I tried to get people in to volunteer. I didn’t qualify for any government assistance for childcare and we just patched together many years and during that time, I - in addition to having a job - had my private practice, which over time grew into a Lyme serving - I’m a psychotherapist - a Lyme serving private practice because my children’s physicians, now Lyme physicians and practitioners, began to refer from me, to me. So currently, my children were 10 and 12 when they got sick. They’re now 30 and 27. They both are still compromised to the degree that they’re unable to attend school or work and I’m still a single mom handling that while I run a private practice and I work - (clearing throat) excuse me - as a social services manager in a hospital to make sure that I have insurance. So, I’m packing together all these things and in my practice, I have the privilege of working with people who have been impacted by tick-borne illness, looking at the psycho-social issues, the neuropsychiatric impact on the person and the family life and dealing with things like having long periods of illness prior to diagnosis, frequent misdiagnosis, seeking assistance and answers from so many different providers, interruption in one’s life trajectory. A huge issue that I deal with in my practice is the medical trauma and the disruption to their personal relationships. So, I work with not only the patients, but the patient’s families and significant others and then also the economic. You know we all know about the economic change of status for some people and earning potential, as well as the spiritual distress and derailment of education and career and the uncertain trajectory so that it’s hard to plan; confusion regarding treatment, choices, self-identity... I mean I could go on and on to the number of things that I approach and come alongside and partner with people as they’re going through it. I’ve done... I do home visits. I do a lot of on the phone. I try to get to where people are so they can seek treatment. But many of the people I see are those that are the lucky ones, because they’ve gotten a diagnosis and they’ve gotten to treatment providers and I’m so aware of the people who don’t from working in a healthcare system that does not - and I’m not representing that here, I’m representing my private practice, but - so many people who are not diagnosed and don’t have access to information or treatment that I see in my other job and when I’m wearing my other hat. So, I’m really thrilled to be here. I have a lot of thoughts and I wanted to do something, but I’ve been so busy being a caregiver. If I’m not at work and managing the, you know, huge expense of funding treatment for two, now adult children, that this is a wonderful opportunity to have an outlet for all the learning I’ve been doing in my private practice and in my home life.
Karen Vanderhoof-Forschner: Excellent. Can I jump in here and say that we have 10 minutes and in that 10 minutes that’s remaining for the hard stop, I know Rich wants to start sending out Requests for Information and I’d like to facilitate that by going through what I sent to you on the inventory - Oh, there we go. Somebody is moving the slides forward. It’s not... I don’t... Yeah. There it is. Inventory and I’ve sent you a copy of the sheets and I’m hoping you can pull them out and have a chance to look and I just want to go through and see if there’s controversy or if we can move through this fairly rapidly, because I’d like to facilitate this for him and if we can’t do it now I’ll schedule...see if I can schedule something for next Wednesday. Let me just ask, are Wednesdays okay? Because I know Len sees patients today and he canceled his patients so that he could be here. So, can you tell me, anybody object to our meetings if we have them on Wednesdays from noon to two?
Anna Frost: Is there any possibility...
Leonard Schuchman: No objection.
Anna Frost: ...to make it later, a little bit later in the day?
Karen Vanderhoof-Forschner: Yes.
Ana Frost: If necessary we can do it?
Karen Vanderhoof-Forschner: 2 o’clock to 4 o’clock?
Anna Frost: Two to... Are you talking about Eastern Standard Time?
Karen Vanderhoof-Forschner: Yes. I’m sorry. Eastern Standard Time - during workdays for, you know...
Anna Frost: I have a hard stop on Wednesdays at 1:30 Pacific Standard Time.
Karen Vanderhoof-Forschner: That’s 3:30. No. 4:30 here?
Scott Cooper: 4:30.
Karen Vanderhoof-Forschner: Oh, so if we end at four we’re good. If we hard stop at four we’re good. Okay.
Female: Do you know how often we’ll be meeting? How often is it? Is it every Wednesday?
Karen Vanderhoof-Forschner: No, no, no. I don’t know which Wednesdays. I have to work this out with the officer that has to be here and with the people who do the slides and what not, but if we don’t get through the inventory we’ll need to have this, because it will slow everything down and with all our questions we’ve slowed them down fair amount. So, do you have your inventory of DOD “tick-borne disease projects and activities” sheet that I sent out to you yesterday?
Anna Frost: Yes.
Karen Vanderhoof-Forschner: Okay. On page one I wrote my suggestion is it’s not what they’re doing currently but what they have done regarding tick-borne diseases to know... Uh, that’s before Section A and then in focus area “agency overview” on this form I also asked for tick releases and I sent out to you Jim Oliver’s information where Fort Dietrich was dropping tick bombs around the country and trying to do bio warfare and so I want to...thought that maybe this will be the time to get ahead of all that if we knew which ticks were spread around the country and where. So, I added a little box for tick releases. Then on that page I asked for medical care and protocols for patients seeking diagnosis and treatment for tick-borne infections. Now that would be... I’m going back. Oh, here it is. That would be adding a request from CMS for Medicare and Medicaid, Department of Veterans Affairs, and the Bureau of Indian Affairs, which I think might be the Bureau of Native American Affairs. So those are...
Nicole Malachowski: This is Nicole. I think I absolutely agree with the Department of Veterans Affairs. I’m 44 days into trying to get them to acknowledge tick-borne illness at large and they need to be made aware that they need to do this. So please do add VA.
Karen Vanderhoof-Forschner: Do you know Sam Donta? He’s on one of the other committees, but he’s...
Nicole Malachowski: No, but I’d like to...
Karen Vanderhoof-Forschner: He’s in here...
Nicole Malachowski: Please make a connection. I’d be happy to buy him a coffee.
Karen Vanderhoof-Forschner: Okay. He’s out,.. Where is he? He’s out on the Cape. He used to have a... He’s a Veterans Affairs doctor, too, and he’s very into Lyme...not into, but knowledgeable about Lyme disease. So those are what I’m asking to add. Anyone else, that you can think of, on this first page? (Silence.) On the second page I am adding where it says, “Check the box for tick-borne diseases” and this is based on input that I’ve had from our phone conversations - I’m adding, “tick paralysis, Bartonella, Alpha-Gal, and Borrelia hermsii,” because I’d like to see those specifically addressed and then at the bottom I added a 15...
Nicole Malachowski: Karen?
Karen Vanderhoof-Forschner: Yes.
Nicole Malachowski: Thank you for adding Borrelia hermsii of which I actually *** (indistinct - 00:55:06) from and that’s the reason why my Lyme tests were negative, but also all of the... I think all of the other strains of Borrelia. I think in terms of military families - I apologize, because that’s the paradigm that I’m coming at this from - but we have things like Borrelia Miyamotoi (sp?) on the...
Karen Vanderhoof-Forschner: Yes.
Nicole Malachowski: ...Borrelia Mayonii up on our northern and Midwestern bases. So like all strains of Borrelia.
Karen Vanderhoof-Forschner: Okay. All Borrelia strains.
Nicole Malachowski: Or Borrelios. Uh huh.
Karen Vanderhoof-Forschner: Yeah.
Nicole Malachowski: Thank you, ma’am
Karen Vanderhoof-Forschner: Very good. I like that.
(Several people speaking at once - 00:55:39.)
Holiday Goodreau: Karen, this is Holiday Goodreau./p>
Karen Vanderhoof-Forschner: Hi.
Holiday Goodreau: Could we also add Bartonella?
Karen Vanderhoof-Forschner: I did.
Holiday Goodreau: Okay. I did not see it on there.
Karen Vanderhoof-Forschner: Tick paralysis... Maybe I did it right now, but tick paralysis, Bartonella, Alpha-Gal, and Borrelia hermsii, and now Borrelia other strains.
Holiday Goodreau: Great. Thank you.
Anna Frost: This is Anna Frost. I would - just to add to this conversation - Lyme disease is quite vague and I would argue that most people would have varying degrees of understanding of what that is. So, if we could, you know, mete out exactly...like all the different Borrelia strains and any other bacteria or parasites, that would be... I think that would be a lot more precise than just Lyme disease.
Operator: Pardon the interruption. This is the operator. You have two minutes remaining before we join you back to the main call.
Karen Vanderhoof-Forschner: So, okay. So we can finish another day.
Female: Can I ask a quick question, Karen? Just a really quick question on that section that we were on, Section C.
Karen Vanderhoof-Forschner: Yeah.
Female: Just something really quick that I know we face on a daily basis here and you guys face it probably there, we’re listing all the tick-borne diseases individually and I know there’s a really huge confusion surrounding somebody...when a patient presents with more than one.
Karen Vanderhoof-Forschner: Yes.
Female: So, is there a way to have a box that just says, “co-infection” so that they’re keeping the lid off the top of the box to just not put them in one box and forget about looking at everything else?
Karen Vanderhoof-Forschner: You know who said that to me the other day, Len. Len said he has people coming in thinking that the best thing they know of is Lyme disease, but they have the other infections.
Female: Right.
Karen Vanderhoof-Forschner: And he said, we call them co-infection, but if you don’t have Lyme those are the infections. That’s what you’ve got to test them for.
Female: And that’s a conversation I have with doctors all the time, because they treat for one thing and it doesn’t address something else and the patient stays sick and I say to them, “Did you check for the presence of co-infections?” And they look at me like, “What?” So, I just wondered if that should have its own box.
Karen Vanderhoof-Forschner: I think you’re right. I think you’re right. And what I’ll do is we’ll work on this particular form for him by email back and forth if we can - if everybody’s agreeable to that and I’ll type up the changes. Can somebody send me the spelling for Miyamotoi (sp?) and the others? (Silence.) Are you there?
Anna Frost: Yes. This is Anna Frost. I can do that.
Scott Cooper: Great. Thank you, Ana.
Karen Vanderhoof-Forschner: Thank you. I appreciate that and I will get this done so that Willinsky...Dr. Wil... Well, Rich will have it probably by Monday and then he can send it all out and you’ll all see it first. And then I’ll tell about meetings on Monday and thank you everybody for coming and being here.
Scott Cooper: Yeah. Thank you all, again.
Female: Thank you.
Scott Cooper: Yeah. You know, just hearing everybody’s introductions, I think we’ve got a great group assembled, a really diverse group, a lot of different perspectives, but professional and personal. So, thank you, everybody. Okay. I think that’s it. We’re going to go back to the main meeting now. Thank you.
Several people: Thank you.
(End of Breakout Session 4 - 00:59:18.)
Breakout Session 5
Vaccine and Therapeutics Subcommittee
Operator: Welcome to the breakout session. Your topic today is “Vaccine and Therapeutics.” As a reminder, subcommittee members, please press star six to mute and un-mute your line. I will now turn the conference over to Dennis Dixon. Thank you.
Dennis Dixon: Hi everybody. Dennis Dixon here. Leigh Ann Soltysiak 0:00:40 to 00:01:25.
Operator: Your additional speaker, Leigh Ann Soltysiak, has also joined. (Silence.) You may begin.
Dennis Dixon: So, operator, are we also going to have tech help with getting our cameras running? I think it’s waiting to be activated by somebody downtown and HHS.
Operator: I’m sorry. I didn’t quite make out what you said. What was the name of the person?
Dennis Dixon: Dennis Dixon here and I’m waiting for our members to come on board and also I asked you if there is going to be tech support on with us, because it looks like someone else is controlling the camera access downtown. I’ve been given permission to share, but mine is not showing up.
Operator: Just a moment, sir.
Dennis Dixon: Debbie, I see you’re on.
Dennis Dixon: I have an IS tech support here with me and he’s already got me to the camera step, I think.
Dennis Dixon: David, I see you’re on and I want to do a sound check with you. Can you hear me all right on your phone? (Silence.) Or Felipe?
Felipe Cabello: Hi.
Dennis Dixon: Or Monica?
Felipe Cabello: Hello, I’m fine here. Yeah.
Dennis Dixon: I was getting an echo on that line, so I’m trying a different phone.
Felipe Cabello: Okay. I’m okay.
Dennis Dixon: Good.
(Pause.)
Dennis Dixon: Leigh Ann, while we’re waiting, do you use both of your names or just Leigh?
Leigh Ann Soltysiak: Hi, good afternoon. I do go by Leigh Ann. Thank you.
Dennis Dixon: I thought so. That’s why it’s written down.
(Pause.)
Dennis Dixon: We’re close to being all gathered. I’m going to do a quick check before I get us started. (Pause.) I believe Stanley Plotkin is traveling and I haven’t heard from Rob Smith yet, my co-chair. He is not expected to be on the call. We’ve been in communication and we’ll continue to do so. So that leaves Maria Gomes-Solecki.
Maria Gomes-Solecki: Here.
Dennis Dixon: Paul... Oh, Maria. You’re there?
Maria Gomes-Solecki: Yes. I’m here.
Dennis Dixon: Okay. You’re not logged in on the screen here so I’m not seeing you there.
Maria Gomes-Solecki: I am not,... What do I have to do then to be present here? I can see you and I can see...
Dennis Dixon: Okay.
Maria Gomes-Solecki: ...the slide.
Dennis Dixon: Good. So that’s all that counts. How about Juan Salazar? (Silence.) Juan, are you with us yet? (Silence.) Or Pal?
Utpal Pal: Yes, I’m here.
Dennis Dixon: Oh, good.
Utpal Pal: But I can see the video, though.
Dennis Dixon: Good. I’m not sure why you’re not showing up on the participants screen. That’s not critical.
Utpal Pal: Okay. But I can hear you clearly.
Dennis Dixon: Very good. I think we only have one more member and I don’t know if Juan is going to be able to join us or not, so I’ll hold on just a couple of more moments and you could all easily prove me wrong, but I think we we’ll have plenty of time to get through the essence of what we would like to talk about in our allotted hour. So I’m not concerned about being stressed for time. (Pause.) Juan, have you joined - Juan Salazar? (Silence.) And Stanley, I’m not expecting you to be on, but if you want to surprise me please say hello. (Silence.) Okay. Since we’re coming up on 2:13, I think I’ll go ahead and start and someone can help me remember after we’ve gone through our identifying ourselves and sharing our life story we can check back and see if Juan has joined us. So I’m going to see if I can advance our slides. Our mouse is now stuck to the table. It’s not a good idea to drink coffee while you’re doing your computer work. (Pause.) Now this is not going to be in automatic load. I don’t think I want that. So here’s where I am on our slides. We’re just going to go through and get to know each other on the first call. I’ll start by giving just a rough idea of the level of detail, and you see here is our prompt. Here’s our cue cards where we say who we are and where we are and what our title is and how long we’ve been connected to the tick-borne diseases. So my name is Dennis Dixon and I have been at the NIH for 26 years and still happy to be here, still enjoy what I do, and since becoming branch chief just a couple of years after that at the National Institute of Allergy and Infectious Diseases in the Bacteriology and Mycology Branch, Lyme immediately fell within my purview and we had a lot of activity going on at that time. So my group now has several members, I think some of you already know Sam Perdue, my section chief, and Maliha Ilias, our program officer, and they’re both sitting on overlapping subcommittees themselves. They are working with me on this. Before I came to NIH, I was trained as a medical microbiologist. I was in academia for 10 years. I moved to a clinical laboratory setting in Albany, New York and was a clinical laboratory director in medical mycology for several years and then moved to NIH. I did my doctorate work at the Medical College of Virginia and was asked to volunteer at a shopping mall in grad school where we were giving an in-service explanation to Rocky Mountain spotted fever, which was a big deal in Virginia where I was. So I’ve had connections to these things going back longer than you’d like me to remember. I think that’s enough on just a little bio sketch on who we are. Times for questions at the end, but maybe we can move on now and in the order I have on our handout that we got and go to Monica Embers next and ask if you could tell us the same sorts of things about yourself.
Monica Embers: Okay. Can you hear me?
Dennis Dixon: Yes.
Monica Embers: Okay. Uh, so Monica Embers. I am currently an assistant professor at Tulane University; though I’ve been there for 15 years studying Lyme disease. I’m working on changing that. So my primary focus has been on using nonhuman (?) primate model for research in Lyme disease, but we’ve also looked at some aspects of relapsing fever as well. Notably, because we use this model, our focus has been on translational types of research, diagnostics, therapeutics, and I haven’t worked specifically in vaccine, but I think, uh, our model is apropos for it. I know that the original OspA vaccine was tested in my department. So I look forward to serving on this group and thank you.
Dennis Dixon: Thank you, Monica, and thank all of you for your willingness to serve, which I should emphasize more than once during this call. We couldn’t do this without your help and I’m certainly going to need it and Rob also appreciates that. Next, why don’t we move to Maria Gomes-Solecki and have you tell us about yourself.
Maria Gomes-Solecki: Yes, so I am currently Associate Professor of Microbiology and Immunology at the University of Tennessee in Memphis. I’m also CEO of a company, Immuno Technologies, also based in Memphis. I have been working in the Lyme disease field for the past almost 20 years. As a associate professor in Tennessee I’ve been 10 years and for this time I’ve mostly focused on development of diagnostics and vaccines for spirochetal disease including Lyme disease. I guess, one of my contributions so far has been the development of a reservoir targeted vaccine, uh, that for Lyme Borreliosis and this vaccine is now currently undergoing USDA licensing. So I guess I can leave it there.
Dennis Dixon: Thank you, Maria. And now on to Pal Utpal.
Utpal Pal: Yes. Pal Utpal. I’m a professor at the University of Maryland College Park. I’m studying Lyme disease also around almost 20 years now. Our interest is primarily stressed on understanding the mechanism or identifying the virulence determinant protein that bacteria uses and interact with the host and the vector and try to use some of the information to develop neuro-vaccine, at least a vaccine candidate. So I’m glad to be here in the community and I try to share my expertise on the panel. Thank you.
Dennis Dixon: Thank you, Pal. Just to double check to be sure Stanley Plotkin hasn’t joined us. (Silence.) And likewise a double check to see if Juan Salazar has joined? (Silence.) Okay. I guess not. So on to Leigh Ann.
Leigh Ann Soltysiak: Hi. Good afternoon everyone. My name is Leigh Ann Soltysiak. Thank you for having me on the subcommittee. I’ll first tell you about my personal story. I am a Lyme disease patient survivor, as I like to say. I was self-diagnosed first in 2013 after seeing a multitude of specialists, not only with Lyme disease, but with many co-infections. I am now recovered, but I like to say that I live with the aftermath of Lyme disease and the co-infections, and I went through really a hell of a time having gone to the typical treatment with the antibiotic treatment, going through IV antibiotic treatment with a pick line into my heart, and many months’ worth of sitting in a clinic for hours and hours upon end and then also the treatment with many things beyond antibiotics to finally get me better. I also have a 10-year-old daughter who was diagnosed with Babesia, but not Lyme disease, which she has fully recovered. But what makes me unique and I think has helped me to be really valuable to the committee is in my professional career I’ve spent nearly 19 years in the healthcare industry working for Johnson & Johnson in different sectors. I worked in biotechnology and pharmaceutical and in drug device and now I work for myself also with clients who have been in diagnostics and in other life science and startup companies and all of my roles have been in helping products to successfully commercialize. So as I wrote in my application, I am in this very unique position of knowing what it takes to help frame and build a story so that we can take Lyme disease and the tick-borne illnesses and help them really be better understood to the sector of private companies so that they help to - either as a vaccine or as a private company looking at treatments - understand the importance of them themselves getting involved in research and development and investment. I know how to help make those things very important from a market standpoint and I think that makes me very unique; particularly being a patient who is so passionate and have a lot of heart around this ill...disease. So, thank you for allowing me to serve.
Dennis Dixon: Our pleasure, Leigh Ann. We did note those very traits and experiences in both arena, both sets of places caught our attention. And could you also verify how you pronounce your last name.
Leigh Ann Soltysiak: Uh, certainly. It’s Soul-tish-shack. So it’s Soltishak.
Dennis Dixon: I was very close. Thank you, and last but not least, David Walker. (Silence.) Who may be on mute. (Silence.) Or whom I may have chased away by going too slow. I thought I heard David at the beginning.
Operator: He had not joined, sir.
Dennis Dixon: Okay. I had touched base with David last week and I think those of you in the vector-borne area know him quite well. He is a physician expert on tick-borne diseases and esteem member in the community and we can brief him and the others later. So what I would like to suggest is, I’ll start with how I see us meeting our deadline, walking through a flow work plan. I think I now have instructions on how to go through slide set here and see who is...
Felipe Cabello: Hello. Uh, Doctor?
Dennis Dixon: Hello.
Felipe Cabello: Yes. I’m Felipe Cabello. I’m here. I’m on your committee, but I was not called.
Dennis Dixon: And who is this again please?
Felipe Cabello: Felipe Cabello.
Dennis Dixon: Oh, okay.
Felipe Cabello: Should I introduce myself?
Dennis Dixon: Yes, you should. Please do.
Felipe Cabello: Okay. I’m a Professor of Microbiology and Immunology in New York Medical College. I have been working on Borrelia Burgdorferi genetics for over 20 years. I have a special interest in immune response to B-Mpa (?) proteins and lately on the role the *** (indistinct - 00:20:34) response. Right when I got a response in Borrelia might self on the ability of Borrelia to persist in the *** (indistinct - 00:20:45) cycle and I’m very thankful to be part of this committee.
Dennis Dixon: Well, thank you, Felipe. I’ve printed the schedule before your name was put on it. So I apologize for that and I knew your first name, but I’m not great with your last name. Could you pronounce your last name again for me?
Felipe Cabello: Cabello. C-A-B-E-L-L-O.
Dennis Dixon: Okay. The L’s are pronounced?
Felipe Cabello: Yes.
Dennis Dixon: Okay. Well, I lost that bet here in my group. (Chuckle.) So, thank you for proving them right.
Debbie Seem: Dr. Dixon?
Dennis Dixon: Yeah.
Debbie Seem: This is Debbie Seem. Did you also capture... I don’t know if I’m going to get the name right. Philip Paul or Pal.
Dennis Dixon: Yes.
Debbie Seem: Oh, you did?
Dennis Dixon: I did.
Debbie Seem: Oh, okay.
Dennis Dixon: So we did hear from him. Correct Pal?
Utpal Pal: Yes, here.
Dennis Dixon: Yes. He’s a colleague right down the road from us.
Debbie Seem: Okay.
Dennis Dixon: So, I’m now going to go through just what I see as a high level overview of our work plan and our workflow on how I would see this working and we have roughly two months between now and the middle of April and we need to have the final product into packaging form by early May. So with two months, that gives us roughly two sets of four weeks equals eight weeks. So if we were to plan for no more than one conference call per week for about an hour we should have enough to go through the topics and the charge we have - which I think is in the set of slides here that I don’t know that we need to go through in a lot of detail. I’ll summarize it for you. We’re supposed to be doing an identification and analysis of all federal activities that are addressing epidemiological basic translational and clinical research on Lyme and the other tick-borne diseases and to identify gaps, to make observations, and then to develop a summary of what we have gone through, captured, and analyzed. So since there is one committee which focuses on all the tick-borne diseases other than Lyme, it is considered that those...that committee will address all of the topic areas like therapeutics, vaccines, and so forth. So we only need focus on Lyme for the purpose of our inventory for our charge and some of us thought that a good way to start this would be - again, with like in the publication of a scientific paper - where we’re starting from in terms of, what do we have available that’s licensed or recently licensed or no longer available, but was licensed in the way of therapeutics and vaccines? So if we were to start off with the conference call going through licensed drugs that are first, second, maybe third line agents that can be used to treat Lyme disease; that would be a starting point. Then we would do the same for vaccines and we might want to break that up as some people who are doing research right in our own midst on this working group and to the human vaccine that was licensed in the United States and withdrawn. I’ve already spoken to Stanley Plotkin and he is willing to go through the history of that vaccine, its licensure, and its withdrawal. Then maybe have a separate call on vaccines in the veterinary sector and then address vaccines for the reservoir hosts and so forth and perhaps tick salivary vaccines and that sort of other presentation vaccines. We cover that thought. (?) Then we could move on to remaining calls dedicated to the inventories from the government entities. I think the NIH is likely to have the largest holding. If we go through our extramural awards for grants and contracts, we have a large array of things there. We could prepare that and I’d probably have Maliha give the summary from her portfolio on what we have in the form of a table, in the form of a PowerPoint slide set, and a narrative. I think that would take the whole hour and then we could ask the other relevant agencies, such as the CDC, perhaps the FDA, maybe CMS or any of the activities they have going, USDA, and any of the other relevant agencies and I would bet we could do those in one to two additional conference calls. So a little less than eight right there and that allows us a chance toward the end of our two months to maybe do an integrated summary of what we’ve discussed and see what we might be missing and start formulating that into a package. And so if we have speakers who come with a PowerPoint presentation for each of our conference calls we would have documents that form the portions of modules to go into a final product and we could either ask them or we could ask our federal contracted writers to capture the narrative to go along with that and we’d build modules as we move toward the end of our two months and then at the two months we could have consensus discussion and then put things forward for production. So that’s a pretty high level overview. I went through it rather quickly. Why don’t I stop there and let each of you react to that and see if you think there are...if that flies, if there’s anything else we need to add or modify. So I’ll pause here and invite group discussion.
Monica Embers: Hi, this is Monica.
Dennis Dixon: Yes, Monica.
Monica Embers: I’d just like to propose that we invite Richard Marconi to come present one of the meetings on his canine vaccines.
Maria Gomes-Solecki: Uh huh.
Dennis Dixon: Very good choice and we had thought that as well and so I think along with having... Like for example, you may would like to have some material you could summarize and present to the group. People on the call here, I’m hoping that you’ll volunteer to lead some of the discussions where your expertise permits and present to the group or to help us identify external speakers that could come in and present to us. I’ve done this on other FACA (sp?) committees and it’s typical to have an expert from the community come in and summarize. So if we... I asked David Walker if he’d be willing to give the drug summary. He would prefer another expert who spends more time treating Lyme disease, or at least familiar with Lyme disease, to comment on the first like, second, and third line agents for that purpose, for example. But yes, so for the vaccines we could have Rich Marconi or others come in and present on that topic and Monica, we’d want to have you perhaps share some of your work in the same area or maybe put together a recommendation for what the other than human vaccines or the new vaccines conference call might be dedicated to; for example, if you’d like to organize a proposed hour call for that purpose.
Maria Gomes-Solecki: This is Maria and I guess we could... I could also recommend Diana Marcus for the part of the treatments. She’s very experienced in seeing patients and she would be a good person to add.
Dennis Dixon: Absolutely. So that’s a good name to put down. We have a separate subcommittee - I think you all see - for treatment and so we’ll have to build the boundaries between therapeutics which are the “things on the shelf” and treatment “how you use them” and so I think the “things on the shelf” is a lot easier than the “how you use them.” And so I think the inventory is what it is. What’s licensed that people go to for Lyme treatment and we’d let that expert divide it up into however they choose: first line, second line, third line or labeled indication or not and...or maybe it’s mainline and mainstream and then other. And so that would be one name. Does anybody else have suggestions for others if she is preoccupied?
Utpal Pal: Yes, this is Pal. We recently had a Cold Spring Harbor meeting and Maliha and Maria and also Stanley, I recall, was there and that meeting was focused on Lyme vaccines and we can’t discuss it because of confidentiality, but I know that there will be a publication that come out of this conference very soon and I think Steve Schuster is one of those organizers. Maybe we can have some information from them when those information will be available, because that meeting included a panel of experts on vaccines, especially the Lyme vaccines for human use.
Dennis Dixon: Would you be willing to send me an email with a short summary of that and who you think would be a couple of the key people who might represent that summary to our group?
Utpal Pal: Yes. I can do that.
Dennis Dixon: Great. And you have that?
Utpal Pal: I think Steve should...
Dennis Dixon: Do you have my email address?
Utpal Pal: Yeah, yeah. Of course.
Dennis Dixon: Okay.
Utpal Pal: I have your email, I’m sure. I think Steve Schuster I would be happy to and he’s already in one of the other subcommittees. He is in diagnostics, I think.
Maria Gomes-Solecki: Right. Right. He’s in diagnostics, but I don’t know if you can have people in two committees or if there’s some law against that, but...
Dennis Dixon: No law. There’s no law against it. We can ask.
Monica Embers: What about Ben Love?
Female: Who?
Dennis Dixon: For what topic?
Monica Embers: Ben Love. Benjamin Love. Oh, this is Monica. Sorry.
Dennis Dixon: For which topic?
Monica Embers: Uh, for vaccine. Was Ben at this Cold Spring Harbor meeting?
Maria Gomes-Solecki: No.
Utpal Pal: No, he was not.
Maria Gomes-Solecki: I don’t think so. No.
Monica Embers: Okay.
(Pause.)
Dennis Dixon: Yeah, I’m writing and thinking at the same time.
Leigh Ann Soltysiak: I’m sorry. Leigh Ann is back. My line dropped, so I had to wait to get back in.
Dennis Dixon: Did you have any reactions to the work plan if you heard of all that through Leigh Ann?
Leigh Ann Soltysiak: I’m sorry. I didn’t. I was on hold for quite a bit.
Dennis Dixon: Basically we would walk through existing drugs, recently approved and no longer available vaccines, talk about...a little bit about the Lyme, veterinary vaccine situation - because there are still available veterinary vaccines - move into vaccines that target reservoir hosts or tick salivary proteins rather than the microbe, and then move through the US agency inventories of ongoing activities.
Leigh Ann Soltysiak: Okay and do we anticipate looking at a global scope outside of the US for any of these things?
Dennis Dixon: I won’t say no. I think the main focus is to look for current government activities since this is reporting back to government agencies for what they control and this might be captured in terms of... I can see it coming up on the vaccine summaries are given in terms of what companies might be pursuing vaccines for US use and how that might be similar to or different from things in Europe and actually the one I’m most familiar with - the one from Valneva - covers both parts of the world. But I think we’re really focused on US government activities, so we could see, “Do we have unnecessary redundancy and overlap? Do we have gaps because we don’t connect the dots? And is there opportunity for things that are not presently being done that perhaps should be done?”
Leigh Ann Soltysiak: Uh huh. Okay and when you say existing drugs, you’re talking about, in terms of scope, the drugs that are currently being studied with the scope being designed clearly as Lyme disease, or like in terms of investigational drugs that could have potential for indication for Lyme disease, but are not yet being studied? So things that start to have scope-creep if you will.
Dennis Dixon: I think that was two parts. The first part is, “What’s licensed now and available for use?” and then when we move into the inventory we would cover some of the things that represent potential targets for new drugs and there’s not a whole lot in our portfolio that’s moving forward with a potential drug development program. There are a couple. So we would cover what’s on the horizon there. It’s going to be harder for us to get at drug candidates in the industrial sector unless it’s public information and... So any thoughts on how we would get at that?
Leigh Ann Soltysiak: Well, and I don’t want to take you off your agenda, but - and I put a little bit even in my application - I mean because of the many different side effects from the Lyme where my head was going - and I think this will take you off your agenda today - is companies that are, you know, specialists in neurological therapeutics, in autoimmune, in obviously in anti-effectives, but those being able to explore primary endpoints in those spaces, you could argue, are still Lyme disease therapies, because they have the potential to improve outcomes in one potential area, but they may not be curing Lyme disease, but they could certainly benefit one outcome.
Dennis Dixon: That’s a very good point and I think I’ll take that back and talk with Rob Smith and we might also want to touch base with the co-chairs on the therapy session to see if they’re going to pick that up there, because I guess there’s two parts to that or there are currently available things that should be considered for therapy, and that might be the better group to do that if there’s room for new research on candidates; I guess we could bring that up into our discussion as well.
Leigh Ann Soltysiak: Yeah. It really comes back to “How are we defining a cure?” Do you know what I mean? Because primary endpoints versus secondary endpoints. The scope can get very, very large and I did just have one note to myself for this call which is - it almost begs the question around two different work strains which is the vaccine piece of it being focused on -, you know for this group, but under, you know, your direction, of course - vaccine around this “protect” goal; you know reducing infections and bacterial suppression and then the treatment or the therapy piece being all around “cure” and then to me it almost breaks itself into two different work strains, because the potential for work just gets so large, but... I’ll just stop there, because you know there’s so much. (Chuckle.) There’s certainly no shortage of work.
Utpal Pal: I’ve got a comment...
Dennis Dixon: I think...
Utpal Pal: ...*** (indistinct - 00:37:24) abilities. What about the word that has *** (indistinct - 00:37:29) about potential tolerance of Borrelia Bergdorferi to antimicrobials? Is it part of our business to discuss those things or not?
Dennis Dixon: Yeah, we might have one project that’s addressing that concept that will show up on our inventory. That’s the kind of thing I would expect us to register as a comment in gaps and say that we didn’t notice that there was much in that area and that might present an opportunity.
Utpal Pal: Yeah, because having some publications that it say that Borrelia might be tolerant to some antimicrobials and whether this might have some clinical relevance. It’s still up in the air and I think probably we should discuss that too.
Dennis Dixon: And so I think we can bring that up in the question section on “research that is being done currently for therapeutics” and what we have and what we see and what we don’t see that we’d like to see. And I don’t know how much more detail we need to go into it other than it’s a possibility to consider.
Utpal Pal: All right.
Dennis Dixon: And so I don’t think the work stream, once we identify a topic, needs to go a lot beyond that in our first report at the end of this year. I think it’s just sort of making observations. I really see the first part on surveying the landscape and defining “what is” and as a consequence “what isn’t” and then that evolves over future discussions.
Monica Embers: Hi, this is Monica. I think that sort of falls under the auspices of identifying gaps. So we know that there are drug tolerant persisters using current therapeutics, but we’re not seeing the funding to support, you know, testing new therapeutics. But along those lines, I kind of want to back up the truck and ask that we define more clearly the difference between treatment and therapeutics with the other subcommittee so that we don’t overlap too much. Does that make sense?
Dennis Dixon: It does.
Monica Embers: Is that something that we could address in the first session?
Dennis Dixon: I think when we get into... As we specify the agenda for the dedicated call on therapeutics, we’ll try and have the answer for that available, but I think for the licensed products, I would foresee it falling out onto “what’s licensed to treat active infection” and then we can get the answer to the question, “How do we deal with management of signs and symptoms that may not be due to active infection? What has been used there?” And that might just be a listing of what they were and the therapy...the people who are dealing with therapy is how they’ve been used and what they’ve generated.
Monica Embers: So there won’t be any discussion of new potential therapeutics or that might be in the pipeline?
Dennis Dixon: There will in terms of the government activities and so the easiest part is, as we’re doing inventory on what the government is doing, we know what we’re doing relative to drugs and it’s a small space. It’s too how much we state that’s going on in the public sector, we might ask for a literature survey on what we can find in the literature from companies where the Lyme disease is mentioned as a product development plan. And I would suspect it’s going to be a very, very small space, because we have a product development team here where we interact with companies that have been doing it for about 10 years of people trying to make anti-microbials and only twice in the last 10 years have I heard a company have Lyme in their vocabulary.
Utpal Pal: I think that is very important, because I think it... You know, people who treat Lyme disease, they think generally that the antimicrobial work almost 100% of the time; then the need for development of new treatment, it doesn’t exist. But if we go back and we look at the literature that says that some Borrelia and the same conditions might become tolerant for anti-microbials, then the need might arise there; but then we need to discuss that before we go into discussing new therapeutics.
Dennis Dixon: And I think that might come out of clinical evidence on “What is the basis for more development on clinical experience?” And that may come from therapeutics...the therapy working group with whom we’ll try and have a...the chairs will try and catch those chairs and discuss that. (Pause.) One question I have while you’re thinking of other questions is, who is in a time zone right now... This is like a guessing game. Who lives the farthest away from the East Coast so we’ll know what is the biggest time difference for people on this call. Anybody not in the Eastern time zone?
Maria Gomes-Solecki: I am. I’m Central. Maria here.
Dennis Dixon: Which is one hour...
Maria Gomes-Solecki: One hour...
Dennis Dixon: ...behind us?
Maria Gomes-Solecki: ...behind you. Monica too. Right, Monica?
Monica Embers: Yes.
Dennis Dixon: Anybody know of anybody more than an hour behind us? (Silence.)
Maria Gomes-Solecki: Nope.
Dennis Dixon: That’s good if we span only two time zones. That makes it a little bit easier when we’re planning our options for calls.
Maria Gomes-Solecki: I’d like to suggest we also add maybe Frank Yang to the vaccines as he’s doing something interesting with live attenuated vaccines.
Dennis Dixon: Who was that again?
Maria Gomes-Solecki: Frank Yang.
Dennis Dixon: Could you spell the name?
Maria Gomes-Solecki: Y-A-N-G, last name.
Dennis Dixon: And the first name?
Maria Gomes-Solecki: Frank, F-R-A-N-K.
Dennis Dixon: Okay. Thank you. (Pause.) I’ll just slip through some of these slides. You know what our product is, it’s developing a report that will go back to the Secretary and to Congress. My understanding is a lot of what we are doing is identifying the landscape and commenting on it and pointing out what might be opportunities and then that the actual recommendations will come from the FACA committee which is the working group, which is conceived and constructed to give recommendations to the government. It’s a subtle difference; it’s not going to be a major issue for us, because opportunities become recommendations when you point something out. Now there is a Town Hall Meeting that’s going to be scheduled for all the subcommittees to be done at one time point I believe and we will have the opportunity to solicit questions from the public on what we’d like their comment on or we could just let them to comment on what they want to comment on. So one set of questions I came up with - the only one actually, because I think it’s pretty straightforward. The research is the research and the products are the products and what’s not there is the subject to whoever thinks there should be other things done and we heard... You all heard the public comments on the overall working group meeting just before ours?
Several people: Yes.
Dennis Dixon: So we know that not everyone is enthusiastic about the possibility for vaccines and we heard that in the first public meeting is that there was a lot of stated push-back on “vaccines are going to be problematic.” And so one question we could ask is, “What are the barriers to possible uptake and adoption of a safe and effective Lyme disease vaccine?” And then, “What might be some possible solutions?”
Utpal Pal: Right.
Dennis Dixon: And that’s different than saying, “Do you think we should have a vaccine?” It’s asking... You get the answer to that, I think, in perhaps how people responded, but I would put it more in an open-ended assumption that there is the potential for a safe and effective vaccine which we put on the table for almost every infectious disease at some point and they’re almost always hard to achieve; witness efforts towards an AIDS vaccine.
Female: Obviously correcting misconceptions would be our high priority.
Dennis Dixon: How would we phrase that in a... Or you mean just in general in terms of vaccines?
Female: Uh, yeah, especially the Lyme vaccine.
Dennis Dixon: That’s a tall order.
Female: It is a tall order, but there are a lot of misconceptions out there.
Dennis Dixon: Are you going to help us with that?
Female: (Chuckle.) I can certainly try.
Dennis Dixon: Okay. (Chuckle.) We’ll write that down. I’m sure you’ll be a helpful member when we have our vaccine conference calls, probably two of them in total considering the landscape there and if we run into too many good volunteers to speak relevant to time for them to speak, we could also have an elected member speak on behalf of several other types of resources being done in the community - a spokesperson giving an overview of the field and I would suspect that many of the people you mentioned could cover for the others, but we can see if we could... We’ll look at what the options are in terms of who’s available, who’s willing, and how we could give segments of time for various people to give a summary. I like the idea of a Banbury Conference overview, because it’s been done before and it pulls together a recent overview of what’s been compiled by smart people.
Maria Gomes-Solecki: Uh huh.
Dennis Dixon: We’re coming up with 5 to 10 minutes left. What time do they want us back? They want us back at 3:05 to come back into the main time point. That gives us 10 minutes and I’m prepared to give people five minutes for a biological break.
Maria Gomes-Solecki: So can I just ask a question? This is Maria.
Dennis Dixon: Sure.
Maria Gomes-Solecki: So will you share these slides with us and will we get to split the workload today or is this the purpose of the call today or we’ll do that in another call later on?
Dennis Dixon: I can send the slides to everyone. I’ll flip through them slowly in the remaining time, but it mainly shows what the milestones are. We’re going to refine the inventory tool for collecting data about the projects and going through them on my screen, if you can see them.
Maria Gomes-Solecki: Yes, I can see them and it says “deadlines” too, which is important for people to organize their times around.
Dennis Dixon: Yeah. I think the key one is looking for... Obviously, the purpose of the inventory is to let you see what we’re doing in these areas. I mentioned this at the beginning. For us it’s drugs and vaccines and looking at gaps.
Maria Gomes-Solecki: Okay.
Dennis Dixon: And I think we’re really on research on vaccines, research on treatment, and the other part we mentioned about “What is the landscape of what we presently have?” We are focused on Lyme. The other committee for everything but Lyme is focused on the others. Looking for the dates - the key date is May 4th, I believe.
Maria Gomes-Solecki: Okay.
Dennis Dixon: And that is when we have to assemble the final product to HHS to be put into a final package. So that’s why I picked the arbitrary date of the middle of April where we finish our group calls so that we can be packaging the modules up into what would be that report. So I think we need to have up to eight calls scheduled between a week from now and the middle of April.
Maria Gomes-Solecki: So should we decide on a day of the week where that would work for everybody on the call that will be booked already?
Dennis Dixon: We can try that. Let’s see, we’re missing a couple of people and that may throw us off. We’ll do a doodle poll, I think our friends at HHS are going to help us with that, but if there’s any absolute hard stop can’t do mornings or afternoons on a particular day of the week, it would be good to know about those now. (Silence.)
Utpal Pal: This is Pal. So I was thinking about the names of expert, external expert and I think Linden who...from Tufts would be one to concert if you think... I know he works on the *** (indistinct - 00:52:18) vaccine that *** is involved, but also as a clinician he also has expertise in human Lyme vaccine. I think he would be...
Maria Gomes-Solecki: Yes. I agree.
Utpal Pal: ...an idea for concern.
Dennis Dixon: Yes. Agree. For me personally afternoons are better for calls then mornings. How do other people feel?
Maria Gomes-Solecki: Afternoon is better for me as well. Maria here.
Utpal Pal: Afternoon is better for me. Pal here.
Monica Embers: Afternoons, yes.
Dennis Dixon: Look how well we get along. This is going to be a pretty good day.
(Laughter.)
Felipe Cabello: I still have a question regarding confidentiality; if the confidentiality, uh, also between the members of the group? Can we talk among each other or we cannot talk only on the meeting?
Dennis Dixon: I think so. I think that... We’re supposed to contain this conversation to our subcommittee.
Felipe Cabello: Our subcommittee...
Dennis Dixon: And then... So that is us. That is us on this telephone call.
Felipe Cabello: Okay, but...
Dennis Dixon: So I can foresee that it would be useful to have a sub-subcommittee where some of you who are helping to frame a discussion around one of the focus areas we described, maybe it’s reservoir vaccines or something other than vaccinating a human against the microbe. That broad “other category of vaccines” could be several of you get together and come up with some...a draft agenda to share with the rest of us for using that hour effectively. So I’m thinking that an hour is about all that we can spare and still have a focus. We did that on two other FACA committees where I sat on. We had a lot of calls, but we never had anything more than an hour and we had usually two speakers.
Felipe Cabello: And I have another question. Who’s going to do the writing of all these deliberations of the committees?
Dennis Dixon: We have writers to help us. I think if the understanding could be that the person presenting comes with a PowerPoint set and if for some reason they don’t do PowerPoint, but would prefer to provide an outline document in Word or some other form, that would be a form of writing right there and if it’s not being too demanding, it would be really great to have that individual write a text to go along with their presentation if they’re willing to do that. And if that’s not feasible, then have the writers develop...try and capture what they heard of the presentation for the presenter to edit.
Felipe Cabello: Wait. We have advice...
Dennis Dixon: And I think it would be... We would be beholding to you to help us so it’s not all on the co-chairs to do the writing at the end. (Pause.) We’re coming up on time. If any of you would like to volunteer to help with any of the topics. It sounds like a lot of people are interested in vaccines; so I hope some people are interested in “existing drugs” and other topics. Could you send me an email...
Monica Embers: Yeah. I’ll go the other direction.
Dennis Dixon: In drugs? Good. So if you could send what you think would be...you’d like to help with and how you see it going, I’d really appreciate that.
Maria Gomes-Solecki: Yes, I’m comfortable... This is Maria here. I’m more comfortable with the reservoir targeted vaccines.
Dennis Dixon: Well, why don’t you send me a suggestion along those lines and I’ll see what else I get and then I’ll match everybody up on that email conversation.
Utpal Pal: Okay.
Monica Embers: Okay.
Maria Gomes-Solecki: Okay.
Dennis Dixon: And I would hope that within one week or two at the latest and it may take a while, because we’re going to need to have that first person prepared to lead our didactic summary. If not, we’ll aim for a call in about a week where Rob Smith is available to sort of summarize what we heard today and a rough draft of what our schedule might look like.
David Walker: This is David Walker. Can you hear me now?
Dennis Dixon: Yes I can.
David Walker: Well, I’ve been on the call all along and only now I’ve been able to connect to be able to speak, so. I don’t have any...
Dennis Dixon: (Chuckle.) Oh, I’m glad you were there.
David Walker: Yep.
Dennis Dixon: Any comments toward...as we sign off?
David Walker: No. I just wanted you to know I was listening all the way.
Dennis Dixon: Thank you very much, David.
David Walker: And I would... You could send me back to the specific request that you gave me earlier and let me see if I can think about it, okay?
Dennis Dixon: Okay and we had some people here who were suggesting... I heard a lot of suggestions for people to help with the vaccines, not so many on... Oh well, I did hear Adriana Marcus that might be able to talk about...
Operator: Pardon the interruption. This is the operator. This is your two-minute warning. Thank you.
Dennis Dixon: ...that may be able to accommodate on...comment on therapeutics. So we can do that and what time is it in Texas now?
David Walker: We’re central time, 2:02.
Dennis Dixon: Central time. Good. Good. We are all looking at two, uh, one hour of each other. Excellent. Thank you everybody. So we made it through and I think we have a group that’s not going to be shy to share information moving forward.
Maria Gomes-Solecki: Okay. Very good. Thank you.
Felipe Cabello: Thank you very much.
Dennis Dixon: Okay.
Utpal Pal: Thank you.
(End of Breakout Session 5 - 00:58:09.)
Breakout Session 6
Other Tick-Borne Diseases and Co-Infections Subcommittees
Dr. Wolitski: Okay.
Dr. Green: Hello.
Dr. Wolitski: Hello. This is Rich. I’m going to put you on mute for a moment. It looks like they’re moving us individually into the breakout rooms.
Dr. Green: Okay. I also said, “Guest.”
Dr. Wolitski: You said what?
Dr. Green: I also went in as a guest, but it’s not letting me in.
Dr. Wolitski: Oh, okay.
Dr. Green: This is Christine Green.
Dr. Wolitski: Okay.
Dr. Green: Maybe now.
Dr. Wolitski: So if you were... I imagine that they may... Are you still logged in to the main webinar or did you log...were you logged out?
Dr. Green: I am. Do I need to log out of that?
Dr. Wolitski:: No. I would not, because I bet you they’re going to move you from your name from the main one into the subcommittee meeting, because...
Dr. Green: Okay. Then I hit my subcommittee link, it wouldn’t open. I’m frozen...
Dr. Wolitski: I think...
Dr. Green: ...on Adobe Connect.
Dr. Wolitski: Okay. So I think they... I would wait a minute and... You’re here, so you got it...you got the audio portion of it, which will probably get you 90% of the way there.
Dr. Paddock: But she... Chris here. You’re in which committee?
Dr. Green: I’m in the “other tick-borne diseases.”
Dr. Paddock: Which is not this line.
Dr. Wolitski: Right. Oh, this line.
Dr. Paddock: Yeah, because I’m now in “testing,” right?
Dr. Wolitski: Right.
Dr. Green: Oh, how interesting. And she did ask me. I’ve been on since your meeting started. She did ask me which one I was on; no she told me which one I was on.
Dr. Paddock: She told you that she knows that you she knows that you’re...
Dr. Green: That I was listed as “other tick-borne diseases and co-infections.”
Dr. Paddock: Yeah. Hmm.
Dr. Wolitski: I’m just going to go to my office and then...
Dr. Aucott: So Chris, do you have any way to communicate with the people running the webinar - like a message or something?
Dr. Paddock: In the Q&A box?
Dr. Aucott: Yeah.
Dr. Green: Oh, yeah. Maybe I can do it right here. Okay. I should be in “other tick-borne” and where am I? Where are you, John?
Dr. Aucott: You’re... I’m supposed to be in “testing and diagnosis.”
Dr. Green: Okay.
Dr. Jones: I’m on this line also. This is Paula Jackson Jones. My audio line is in this group, but my web is on the “access to care services.”
Dr. Aucott: Which one are you supposed...
Dr. Green: Well, my web won’t open.
Dr. Jones: I think I’m only partially moved over.
Ms. Dulaney: Yeah, this is Megan Dulaney. I’m in the same boat. My online has me in the “other tick-borne diseases,” but we’re obviously still on this line.
Dr. Jones: Yeah.
Dr. Aucott: All right.
Dr. Munderloh: I’m Ulie Munderloh. I haven’t gone anywhere. I just got into Adobe Connect with some instructions that have nothing to do with my subgroup. I clicked on the subgroup and it just went into some kind of explaining how to chat and give some examples, but I’m not there.
Dr. Jones: Are they going to move each individual phone line over to the appropriate subcommittee?
Female: Yes.
Dr. Aucott: That was the plan, exactly. So it may just be taking a while I wonder.
Female: Okay.
Dr. Aucott: Do you have like a chat bar on the side, though, that you can chat with the group and tell them your situation?
Dr. Jones: Well, she didn’t ask me what group I was going into when I called in; so I don’t think they know where to put me.
Dr. Aucott: Right. So do you have a chat bar?
Dr. Green: They did tell me... This is Chris Green. They told me they could look at a list and tell where I was. So maybe they could for you too.
Dr. Horowitz: And John, this is Rich Horowitz. I can sign in as a guest, but I don’t see like a specific password to sign in as a co-chair.
Dr. Aucott: All right. So it looks like a lot of people are still on this main line right now.
Dr. Green: Yep.
Dr. Aucott: Because you’re... I think you all are still on this mainline and not on your subcommittee line.
Female: So I’d maybe give it a minute.
Dr. Aucott: So I think we just want to wait a little bit. It may be taking them a while to move everybody over. Rich, I don’t know I’m yours if you, you know, they know you’re the co-chair?
Dr. Horowitz: Is it okay to just sign in as a guest and then it will allow us to talk? I mean, can I just sign in as a guest, even if I’m not signing in as one of the co-chairs?
Dr. Aucott: Uh, you’re not planning on using slides there anything right?
Dr. Horowitz: No.
Dr. Aucott: Yeah. Then I guess it would be.
Dr. Horowitz: Okay.
Dr. Aucott: I’m not an Adobe Connect expert, though.
Dr. Jones: They didn’t ask me where I was going; they just put me into the working group line. So I don’t think I’m connected to a subcommittee.
Dr. Aucott: So maybe you do have to go back out and come back in then again, because...
Dr. Jones: You mean, get off the call and come back in?
Dr. Aucott: Yeah. But I would...
Dr. Perdue: This is Sam Perdue. Which call am I on now?
(Laughter.)
Dr. Green: The one with...
Dr. Perdue: Because I just hung up and called in again and they said, “Which group?” and they said, “other tick-borne diseases” and I don’t think I’m in that one.
Dr. Aucott: Well, you may be, I mean...
Dr. Green: Well, I’m on “other tick-borne diseases.”
Dr. Aucott: Maybe this is the “other tick-borne disease” line and I’m on the wrong line.
Dr. Paddock: Hey, this is Chris Paddock. I’m on the “other tick-borne disease” line.
Dr. Aucott: Well, Rich, this is probably your group then.
Dr. Munderloh: Yeah, at least I’m also in the “other...”
Dr. Aucott: So you guys should all stay on this line.
Mr. Lubelczyk: Yes, hi. This is Chuck Lubelczyk from the Maine Medical Center. I’m also supposed to be in the “other tick-borne diseases” and I’m on this line still.
Dr. Aucott: So you guys are all in the right place and I’m in the wrong place. Go for it. You’re together.
Dr. Jones: I’m in the wrong place too.
Dr. Dulaney: John...
Dr. Aucott: I think this is the “other tick-borne disease” line. Okay?
Dr. Munderloh: I believe so.
Dr. Horowitz: Great.
Mr. Richards: It is.
Dr. Horowitz: Alan, are you on the line? This is Rich Horowitz.
Dr. Jones: All right. I’m hanging up and calling back.
Dr. Greene: For what it’s worth, I cannot connect to the “other tick-borne disease and co-infection” webinar website or whatever. When I clicked there I get frozen.
Dr. Aucott: So I think you’re good, Chris. I mean, this is basically a verbal call anyway.
Dr. Green: Oh great. Okay.
Dr. Aucott: I don’t really think you need the webinar per se, because Rich, you can run this meeting without the webinar, right?
Dr. Horowitz: Absolutely.
Dr. Aucott: Yeah. So Rich, I think Rich and Alan just run this meeting like a conference call, basically.
Dr. Green: Oh, well. Good. Good.
Dr. Aucott: Yeah. I don’t think you need the webinar part.
Ms. Maloney: John, this is Betty. I’m supposed to be on the “pathogenesis” call and they put me into here. So do I need to call back?
Dr. Aucott: Yeah, you’re in the wrong place for sure, because 90% of the people on this call are in the “other...the “co-infection” call.
Ms. Maloney: Okay. Thanks.
Dr. Aucott: Yep.
Dr. Haller: So John, this is...
Dr. Green: Hi, Betty.
Dr. Haller: Sorry, this is Enid. For some reason I’m still on this call. What phone number do I call to get moved?
Dr. Munderloh: The same one you originally got.
Dr. Green: Hi Enid.
Dr. Haller: Hi Christine.
(Laughter.)
Dr. Green: How nice to hear your voice.
Dr. Haller: Okay, so I just call back the main number again, is that correct?
Female: I think so.
Dr. Haller: Okay. I’m going to do it. I’ll hang up. Bye guys.
Dr. Green: Bye.
(Pause.)
Dr. Munderloh: We just got an email, by the way, from Jennifer Gillison with clicks for the subgroups - so I mean links to click. Maybe that will do something new.
Dr. Wolitski: I wonder what room Al is in.
(Beep sound.)
Dr. Horowitz: Yeah, Al, you’re on the line yet or no? (Silence.) I guess not.
Ms. Dulaney: Hi, this is Megan. Dr. Horowitz, I just saw your video line come up on my end.
Dr. Horowitz: Okay. Yeah, why don’t we take... Why don’t we at least take a roll call for the moment so we know who’s on while we’re waiting maybe for Alan. So, Megan you’re here. Marna, are you on the line?
Dr. Ericson: Yes, I’m here.
Dr. Horowitz: Great. Great. Nice to meet you. Chris, are you still with this?
Dr. Paddock: Yeah, I’m still here.
Dr. Green: I’m still here. Yes. Oh... Two Chris’s. I can be Christine.
Dr. Horowitz: Great. Oh, that’s true. Charles? You just called in.
Mr. Lubelczyk: Yes. I’m here.
Dr. Horowitz: Great. Ulie, are you still on the line?
Dr. Munderloh: Yes, Ulie is here.
Dr. Horowitz: Great. Chris Paddock, are you on the line?
Dr. Paddock: Yes, I’m here.
Dr. Horowitz: Okay. Fabulous. Uh, Sam Perdue?
Dr. Perdue: Yes. Here.
Dr. Horowitz: Great and Sam Telford.
Dr. Telford: Yes. I’m here.
Dr. Horowitz: Great. Garth?
Dr. Nicolson: Yes, I’m here.
Dr. Green: Yes.
Dr. Horowitz: Fabulous. I think the only one we’re actually missing is Alan.
Dr. Richard: No, I’m here. I’m here, Rich.
Dr. Horowitz: There we are. Okay. So we’re all together. Fabulous. So welcome everyone. This is great that we’re finally meeting. I’m so happy we’re going to have a chance to work on the problem of co-fections together and help so many people that are affected. So could we just start off with the introductions just one, two minute maximum for each person. Just tell us about yourself, your title, affiliation, and how long you have been involved with tick-borne issues and Megan why don’t you start. We’ll do it in alphabetical order.
Ms. Dulaney: Sure. Hi. I’m Megan Dulaney and I believe I’m the patient rep on this subcommittee. I do work for the Department of Defense for the Assistant Secretary of Defense for Health Affairs and I’ve actually been struggling with tick-borne illness and the complications for about the last seven years. I’ve been diagnosed for about the last two and half years. So it’s been a long journey, but I’m happy to be here and I think my professional experience is going to probably help with the subcommittee work that we’re planning to do. Thank you.
Dr. Horowitz: Great. Thank you. Marna.
Dr. Ericson: Hi. Yes, uh, I’m Marna Ericson. I’m at the University of Minnesota and it’s Ulie who kind of got me involved with this with...
Dr. Munderloh: Oh, don’t blame me.
(Laughter.)
Dr. Ericson: Sorry. ...Anaplasma and then my... I have been using advanced imaging techniques and my main focus now is Bartonella, so... And I... That’s where I’m at.
Dr. Horowitz: Great. Great to have you on board. Chris Green.
Dr. Green: Yes. I am a physician. I treated Lyme, I think, for over 30 years, initially as a family physician and then in the mid-90s as things changed, perhaps more and more as a specialty. I’ve kinda followed, for me, the co-infections as they have emerged and formed the opinion that our problem is still pathogens and co-infections and I’m very excited that there is a subcommittee to really to try to look at this.
Dr. Horowitz: Yeah. It’s great to have you on board, Chris. Thanks for being here. Uh, Charles.
Mr. Lubelczyk: Uh, yes. My name is Charles or Chuck Lubelczyk. I work for the Maine Medical Center Research Institute in Scarborough, Maine and I work as a vector ecologist here studying both tick-borne and mosquito-borne diseases.
Dr. Horowitz: Wonderful. Nice to have you on board. Uh, Ulie.
Dr. Munderloh: Yeah, I’m Ulie Munderloh, also, at the University of Minnesota in the Department for Entomology. My lab has - together with Ceci Goodman who was the FDA director for a while - isolated the Anaplasmosis agent and also more recently the Elicamoras-oclarences (sp?) agent and I’ve been working since my PhD thesis on tick-borne pathogens which was a long time ago.
Dr. Horowitz: Yes, for all of us at this point.
Dr. Munderloh: Uh huh.
Dr. Horowitz: Nice to have you on board. Garth Nicolson.
Dr. Nicolson: Hello. This is Garth Nicolson. I’m a Professor Emeritus of Pathology and Laboratory Medicine from the University of Texas in Houston and I’m the Founder and Chief Scientific Officer and President of the Institute for Molecular Medicine in Huntington Beach, California. Uh, I’ve had a long background in a variety of things, but my interest in this area would be Mycoplasma.
Dr. Horowitz: Great and nice to have you on board, Garth. Chris Paddock.
Dr. Paddock: I’ve worked at CDC for the last 23 years as a pathologist and a Rickettsiologist. I’ve been involved predominantly in spotted fever group Rickettsioses, but also in Ehrlichiosis and Anaplasmosis. I’ve worked with several of the other members of the working group over the past several years; so I was really happy to see their names on the subcommittee list. And I guess, uh, I sure hope there’s an Alpha-Gal expert among us.
Dr. Munderloh: No.
Dr. Horowitz: I’m not too sure...
Dr. Green: Yeah, no kidding.
Dr. Horowitz: We can certainly bring one on board.
Dr. Horowitz: That’s a great part about having people present to the committee. Great, thank you. Thank you, Chris. Sam Perdue.
Dr. Perdue: I’m Sam Perdue. I’m the Program Officer for the Rickettsioses and Related Diseases at NIH and the National Institute of Allergy and Infectious Diseases and I’m also the Section Chief, so, for a whole group of other program officers including those who oversee Lyme disease, for example, the other...one of the other bacterial on *** (indistinct - 00:14:12) hospital infections, mycology, and so forth. So, most of the tick-borne diseases are in my purview in one way or the other.
Dr. Horowitz: Great. Great to have you on board. Sam Telford.
Dr. Telford: Sam Telford. I’m professor of Infectious Disease in Global Health at Tufts Cummings School of Veterinary Medicine, and Director of the New England Regional Bio-Containment Laboratory. I’m an epidemiologist. I’ve been working for 30 years on deer tick transmitted infections starting with the ecology of Lyme disease, moving on to the Ospa vaccine, and relevant to this subcommittee, Peter Krause and I published the paper in JAMA demonstrating that co-infection of Lyme and the Babesia tended to result in more signs and symptoms among patients, but I do warn people that the... We submitted it to the New England Journal and the review came back, “Well, of course, if you have two infections - you’re going to be sicker,” and we had to submit it to JAMA. So with that comment place, uh, co-infections in context. I have worked on co-infections for a long time.
Dr. Horowitz: Great. By the way, I can’t tell you how many times I have used that citation when speaking to people about Babesia; so thank you for the work. Alan, why don’t you tell people about yourself?
Dr. Richards: Yeah. Al Richards. I’ve been working with rickettsioses diseases for over 25 years, both tick-borne and mite-borne and flea-borne. I work for the Department of Defense at the Naval Medical Research Center.
Dr. Horowitz: Great and for myself, I’m Dr. Richard Horowitz. I’m located in the Hudson Valley New York. When I moved up after my residency in internal medicine, I didn’t realize I was moving into the largest Lyme endemic area in the U.S. at that point. I’ve now seen over 13,000 chronic ill patients with Lyme and associated tick-borne. Uh, I’ve written two books which were National and New York Times bestsellers and I published on co-infections in the role of environmental toxins and other things affecting people and I’m just thrilled to have us all together, because our patients who have been coming to us have been looking for answers for a long time and I know we’ve all been working at it; so I think it’s wonderful. We have a very strong committee and I really look forward to working with everyone. So one of the things that Rich and John told us we needed to focus on is, “What do you think is the most important thing or things for us to focus on as a committee?” So you know we have to come back to the group in roughly 40 minutes, 45 minutes. What do you feel and we can just go down the list starting again from Megan downward. What do you think we should be focusing on in this group as far as the co-infections? Which ones do you think are the most important ones that you would like to see us focus on?
Ms. Dulaney: I think in terms of like prevalence, it seems to depend obviously on geographic area. So I don’t know if I necessarily have a preference, but it does seem as though knowledge and awareness of these...the vectors and these other co-infections are limited, at least kind of like on the frontline primary care medicine. The testing seems to be pretty poor and so I think just the lack of awareness if a doctor tests for Lyme disease and doesn’t understand the test or anything else, then also the fact that the testing is very poor. There’s just a general lack of understanding and awareness. So I guess that would be my number one priority.
Dr. Horowitz: Okay. Marna.
Dr. Ericson: Well, of course I’m going to go with my organism of choice which is Bartonella and one of the things that has happened is just due to the fact that I’m in the Department of Dermatology and we are always taking pieces of skin off of people. We’ve been able to do that and it’s been my growing and strong conviction that looking in the blood is not always the best place to look, because we may not have an adequate copy number and I think we need to start looking for organisms in different niches and I will propose that the dermal niche plays a significant role in harboring these organisms.
Dr. Horowitz: Thank you. So apart from Bartonella, because we’re going to probably have to choose several tick-borne co-infections when we come back, but the ones that have the greatest impact, any other suggestions as far as other tick-borne co-infections you’d like to see the group work on?
Dr. Ericson: Well, yes. The other thing that I’d be really interested in is Babesia and the reason being that I have worked, done some work with Red Cross here in town and as far as being a blood-borne pathogen that’s evidence and found in the blood bank supply - as is Bartonella - I think we need to consider the safety of the blood bank supply and so I would vote Babesia as another one I’d like to put at the top of the list.
Dr. Horowitz: And you have a...
Dr. Paddock: Richard?
Dr. Horowitz: ...even a third or a fourth you would like to see?
Dr. Ericson: No. I’m gonna just do those two.
Dr. Horowitz: Okay. Great.
Dr. Paddock: Richard, this is Chris. I had a quick question. When you talk about co-infections are we focusing on things that are associated with Borrelia Burgdorferi or... I mean, because there’s lots of different permutations of co-infections.
Dr. Horowitz: Right.
Dr. Paddock: And then the other question was, you know the group has been tasked with other tick-borne diseases. So I guess I’m... I want to try to get a clearer idea of really what our primary mandate is? Is it both of these things? Because other tick-borne diseases is a very large category in and of itself, so.
Dr. Horowitz: Right.
Dr. Perdue: This is Sam Perdue. I’d like to hear that too.
Dr. Horowitz: Yeah. So, I mean, my take, and Alan, please kick in on this one...
Dr. Green: Me too.
Dr. Horowitz: ...I think it’s going to depend... I can say for clinicians, you know definitely Babesia plays a big role for me in keeping people sick; Bartonella plays a role. I’m personally worried about the Powassan spread. The article that just came out from Connie Knox from Coppe Laboratories were 9.4% of the people in the Northeast have now been diagnosed with Powassan even though...and we had a few deaths in our area here. So at least when I heard about the committees I was thinking the ones that, like are in the blood supply that would affect pregnant women, so you know relapsing fever, Borrelia to me, Borrelia meomotii, (sp?) especially I think is, you know, one that I would be interested in. So for me, but of course, there’s lots of them there. There’s all the rickettsios. There’s tularemia. There’s the Alpha-Gal. I mean, that’s why it’s just a question for all of us to just have a sense of which ones do you think have the greatest impact at this point for our country. I guess that’s one place to start.
Dr. Richards: Yeah. This is Al Richards. So I think Rich is on it. It’s supposed to be by priority. It’s definitely other tick-borne diseases and co-infections. It’s not just co-infections and it’s just not co-infections with Borrelia. So it’s all of them, but it’s such a big area that once we say all the different things that we think are important, then we have to prioritize them and they’re suggesting about five different topics to go into. So as everyone brings up they’re different things, you may, you know, sort of indicate the disease severity or the prevalence incidents or what have you. So it is definitely “other tick-borne diseases and co-infections.”
Mr. Lubelczyk: And Rich... This is Chuck Lubelczyk. Can I just jump in real quick.
Dr. Green: May I go? Yes. Yeah. So, I think part of what we have to do is think about...and I also have used *** (indistinct - 00:22:33) a lot, think about what happens... I mean, of course co-infected people may be sicker, but we don’t know how to tell if they’re co-infected, because we don’t know how the immune response changes and therefore, how the testing changes. So I think we have to think bigger than just tick-borne, because clearly these bugs, at least, manipulate their way around the immune system if they don’t actually suppress certain parts of it so they can continue to infect and then in deliver (?indistinct - 00:23:09) a repeated manner. If I have to pick... The worst one for me is Babesia. I really think we have to start understanding the different species of Babesia; especially duncani out here on the West Coast. Bartonella would be my second and I think there’s such a good literature on that now that maybe we can approach it. Mycoplasma might be my third; although, out here we are getting Rickettsia that are emerging. We keep finding new Rickettsias also. So those would be my votes.
Dr. Horowitz: Great. Thank you. Uh, Charlie, Chuck.
Mr. Lubelczyk: Yeah, well I think up here in Maine we are obviously seeing more recognition of Powassan Virus. So I think, you know, that would be something we are dealing with now, but also, Anaplasmosis and I would put both of those, kinda from an ecological bent in that we are seeing a higher number of these cases now during the adult cohort season as opposed to nymphal cohort season. So I think that in some way there needs to be more recognition of a public health importance to adult stage deer ticks as a vector. So I would just like to throw that out as well. But I would probably say Anaplasma and Powassan if I have to name two.
Dr. Horowitz: Okay. Great. Ulie.
Dr. Munderloh: Yes. I think what everybody has been saying, to me, makes it very clear that we have to, for one thing, change... What would really be important to change how these illnesses or pathogens that cause the illnesses are diagnosed. Currently, most tests are specific for one agent or maybe some of the... Some of the veterinary tests actually are, you know, capture more than one and I believe this with the next-generation sequencing approaches that it’s a really good way of not just looking at one thing, but looking at the sampling of what could be causing the specific syndrome, symptoms, and signs presented by a patient, uh, what could be responsible and also I’d like to reiterate that all of these, starting with Lyme disease when I put it into the limelight, these organisms that we’ve been discovering are emerging or reemerging and we cannot... And also they are very regional in many cases, so that Lyme disease Borrelia are more important in some areas and less important in the South or I’m not saying that they are not important there, but there certainly is much less incidence and people will look for other things first. So I think the way we diagnose these pathogens that are afflicting patients has to change. We have to have a more comprehensive next-generation sequencing approach that we can then get the data and saw through and so that we don’t miss some of these other organisms and that’s actually... So it’s not a next-gen sequencing approach that Bobbi Pritt and colleagues have taken, but they’ve taken approach where they - with a real-time PCR set-up - they can identify something that is not what they expect and then they can start looking more specifically, but I think a next-gen sequencing approach with the capabilities that we have now, most labs have now, that’s really the way to go. That’s these, you know, chip approach basis that can be taken that will give a much broader view of what is there.
Dr. Horowitz: This is... So Ulie, absolutely. Of course, I think we’re all in agreement, but...and we will be doing the diagnostics, obviously, for any of the agents that we choose, but among them, do you also feel like Babesia, Bartonella, Mycoplasma, Rickettsia, Anaplasma, Powassan, Borrelia meomotii, (sp?) Relapsing fever: are there any specifically, because it is about five topics?
Dr. Munderloh: Yeah. So being in Minnesota which has the largest number of Powassan cases reported since it was first identified. Suddenly it’s a very important illness and secondly I think Anaplasmosis...human Anaplasmosis agent is an important one for the reason that it does manipulate the immune system and not the only, but one of the reasons it does manipulate the immune system is by directly attacking the innate immune cell that makes up our first line defenders and then basically it opens up the patient to additional infections of other agents.
Dr. Horowitz: Okay. Thank you. Garth. You’re next.
Dr. Nicolson: Well, since I work on Mycoplasma I’m obviously going to put in a plug for that. Very few people work in this area, so even less for Mycoplasma. So it’s not something that people know about or even bother to test for. But Mycoplasma, in addition to being an insect-borne infection, is also an airborne infection; although, it’s not...it’s highly transmittable in that way, but... So this is something that is a real bother in particular situations. So again, that’s my plug.
Dr. Horowitz: Okay. Chris Paddock.
Dr. Paddock: Yeah, you know, it’s hard for me to sort of consider any of these in isolation. You know, because they’re... You know, when you look at a tick, you know, for example like scapuleris, you know, it transmits a whole suite of different... Well, they all do. They all transmit a suite of pathogens and you know in some ways rather than looking at, you know, well Powassan is what we really need to look at. I kinda think we should be saying... We should be looking at the suite of Ixodes scapuleris transmitted pathogens and the suite of Amblyomma americanum associated pathogens, you know, collectively; because those are the two most medically important ticks in the US. I know that’s a lot to digest, so you know, I think if you’re going to break it down into components, you know just based on the public comment I really think we need to have some discussion about Alpha-Gal and I have to admit, I’m woefully ignorant about this. Its not an area that I have any expertise in, but certainly it’s rising to the top and the public is very aware of it and it seems like ours is the group that this may be falling into. Maybe I’m wrong there. The other thing and we’ve heard it already from the other experts is Anaplasmosis, you know, and that’s something that... You know, curiously it got a lot of attention back in the 90s and early 2000s and then not so much after that, but as far as the Rickettsial diseases in the US, it’s probably the most prevalent and we’re also hearing more and more about transfusion associated cases of Anaplasmosis. So I think that’s an important topic. And then the other thing, you know, tick-borne arboviruses is just something that we know very, very little about. You know there’s a lot of commotion about heartland and bourbon viruses. They’re both associated with Lone Star ticks, but it’s very likely that, you know, all the human biting ticks in the United States have their own specific arbovirus that’s causing a disease that hasn’t been diagnosed. So I think that’s a very important area to sort of to look at and then lastly, you know if you’re looking at lethal diseases, Ehrlichiosis and Ehrlichia chaffeensis infections and Rickettsia or kettsii infection. Those are the ones that kill people and, you know, with high case fatality rates. Again, this is a huge, huge topic and so I kind of feel like we need, you know, some boundaries, some lane boundaries to move forward on this, but anyhow. That’s it for me.
Dr. Horowitz: Yes. Thank you. I mean you’re right. It’s a very large field we’re taking on and I asked John and Rich about this yesterday and that’s why they were suggesting that we kind of choose... The things to focus on would be the ones that maybe have the greatest impact in the largest number of people that’s going to make the biggest difference for the health and well-being of Americans, so; but you’re right, it’s just... It’s huge. Sam Perdue.
Dr. Perdue: So yes. Thanks. I’ll start by passing on a message that was given to me multiple times by multiple people from the community and that was just - and I was struck with this too with all of the talk about co-infections - that...and this is a tick-borne disease working group and right off the bat it has become the Lyme disease working group and there’s no question that it is the most prevalent tick-borne disease in United States; I’m not challenging that, but we have six subcommittees and five of them are Lyme only and one of them is everything else, and so there are a lot of people that are not happy out in the research community that they feel like they sort have gotten short shrift on this, uh, particularly with now we’re starting off with - that’s what I was wondering earlier on, we’re talking about co-infections. So now that’s out of the way and I tend to agree with them, but I certainly understand the pressures that led to all of this. I’m a tiny bit concerned that we’re supposed to be identifying gaps, but right off the bat we’re saying what they are before we’ve actually done the assessment of what they are, but within that realm I can do like everybody else and pick what I think is important and I’m going to sound a lot like Chris Paddock, but... So I mean I think in one area I certainly think that probably if we’re going to focus... When I think of tick-borne diseases I always kinda take tick-centric, because that’s how I was brought up, but I agree that perhaps looking at Ixodes and amblyoma and their pathogens might be the way to go. I think we ought to be spending some time looking at tick questions in addition to pathogen questions; whether that be ecology or not. We got shift in range. We’ve got emerging tick-borne diseases. We got the viruses. We got the E-muris-like pathogen. So those are all, the whole kind of emerging tick-borne diseases is kind of a hot topic now I think. I would actually not put Bartonella... Well, let me rephr... Let me take a step back. The thing I would like to know about Bartonella is, “How prevalent is tick transmission?” and so that’s what we don’t really know. It gets claimed as being a big tick transmitted pathogen, but I have not seen a lot of incredibly strong data reporting that. So that would be a gap I would like to know. You know I think as been mentioned before, Ehrlichia and Anaplasma. Anaplasma is growing in prevalence, particularly with its associated Ixodes, but Ehrlichia it kills you or is more likely to. I think we need a lot on diagnostics for these in order to differentiate what we have and I think another thing that hasn’t been mentioned is tick vaccines, not pathogen oriented, but there are certainly people that have been working on that prize of coming up with something that would protect you against transmission of the disease during the tick bite just based on tick salivary proteins and whether that’s attainable or not I don’t know but I think that’s an interesting area and then...
Dr. Horowitz: Steve Wikel (indistinct - 00:35:18) for quite a while with the tick’s spit vaccine. He’s on one of the other committees. So I’m happy that he’s doing it and of course in Europe they have the tick-borne encephalitis vaccine. When I lived in Europe people got it all the time. So I... But you’re absolutely correct. I mean considering the number of pathogens that can be transmitted by one tick bite, I think that ticks spit vaccine that Stephen Wikel was working on I think would be fascinating.
Dr. Perdue: Right and then my very last one is I agree with people on the Alpha-Gal question. I probably was struck by the number of people who commented and I was also struck by the number of people who got the science, very, very wrong from what we know. So I think that would be worth looking at. Somebody like Tom Platts-Mills come up from Charlottesville or call from Charlottesville to talk about that I think would be very useful, or Dean Metcalf from NIH could do it as well. So those are my incredibly dense thoughts.
Dr. Horowitz: Good. Thank you. Sam Telford.
(Sound of the phone ringing - 00:36:12.)
Dr. Telford: I think I’ll pick up on elements of what Chris and Sam just said and you know, speaking as an epidemiologist, this is a huge topic and we need to sort of align our priorities with the epidemiology. You know what is common, and what is sort of common, and what is rare, knowing of course there are rare agents like Powassan Virus, deer tick virus, I call it, and in the mosquito world, Eastern Equine Encephalitis, very, very rare infections but of high consequence. They’re called high consequence pathogens, but do we focus on them as opposed to something that infects hundreds of times more people than those do? So to align the epidemiology with actual, you know, to do real estimates of burden of disease; but to follow up on Sam’s comment and Chris’s comment, no tick bite is a good tick bite and if everybody focused on prevention and we did something about prevention we wouldn’t be here. We wouldn’t be talking about this stuff. We wouldn’t be arguing angels on the head of a pin in terms of what is most important. But we need to sort of figure out, you know, “What angle are we looking at?” Yes, there are contributions to a pathogenesis of or complications of Lyme disease because someone might be concurrently infected with something else that’s in the environment, uh, parenthetically Bartonella. Uh, if you listen... The last time I heard Ed Breitschwerdt speak, he’s rightly on the focus of the ubiquity of domestic cats and the fact that they are the vector in reservoir of Bartonella henselae which is significantly understudied and this idea that ticks are involved may actually be a red herring. There are other things in the environment out there and we need to sort of have this outlook of environmental contamination of things that might hurt us. So I don’t actually have priorities other than prevention. We just need to prevent tick bites. We won’t get Alpha-Gal that way. We won’t get Powassan Virus as a stroke of lightning or we won’t get Babesia microti which is expanding its distribution throughout the Northeast.
Dr. Horowitz: Yes, absolutely.
Dr. Green: I have a question in light of... Are we... Must we only have tick transmitted pathogens, because the problem is in the patients I don’t know if they get the Bartonella from the tick, but it’s part of their illness and so I thought that was one of the questions kind of up-front is, “Are we focusing just on tick transmission?” Although, I agree with you, Dr. Telford, I think we have to start preventing these things, but right now I’ve got sick patients.
Dr. Horowitz: Yeah. I... Chris, its Richard and I have the same problem. I have about 15 positive FISH tests for Bartonella in people that were treated with long term antibiotics.
Dr. Green: Right.
Dr. Horowitz: ...antibiotics and I don’t know where they got it from. I don’t know if it’s from a tick or it’s from a flea or a cat or lice or whatever it’s from, but they’re definitely coming down with that and when it’s treated it does seem to make a difference in getting them better. I mean you and I have talked about this. So yeah.
Dr. Green: Well, in terms of Marna’s work too, I mean I just found one of my patients had tissue-based Bartonella. We could not find a PCR or culture positive, but we did find it in tissue. So it... I don’t know. I don’t know what our mandate is, but that concerns me in terms of coming up with a plan that we’ll research what’s going on so I can treat these patients better and we all can, so.
Dr. Horowitz: Thank you. Alan, what would you like to see?
Dr. Richards: Well, I like sort of some of the things that everyone else has already said; certainly Ulie’s next-generation sequencing where you can look at 16 S (?indistinct - 00:40:37) sequences and identify various pathogens at one time and that would certainly address the issue of co-infections or just different tick-borne diseases. I also like the idea of investigating skin, if there’s a rash, and otherwise as a source besides blood to do that advanced diagnostics. I know there is a diagnostic section, but I think, as Sam indicated, that’s going to be solely dealing with Lyme disease and so I would like to keep in mind that diagnostics is very important. We need to identify what these causes of tick-borne diseases are and I think that is a gap that we have and the other gap is Alpha-Gal. There’s just so many people. It just seems to be a growing issue and I’m not sure that’s going to be tackled in the other groups either. So...but those are the areas that I would like to be addressed.
Dr. Horowitz: Okay. Good. You know, for myself, I mean as far as the patient’s that I’m seeing that are staying ill, I’m seeing an awful lot of Babesia. I am seeing a fair amount of Bartonella. We are seeing evidence of persistence of both of them with standard treatments, whether it’s Mepron, Zithromax, Clindamycin, and quinine, etc., I think the Alpha-Gal is definitely an important one, because it’s causing anaphylaxis. Myself, I’m also interested in the relapsing fever Borrelia with B miyamotoi simply because the standard testing for Lyme is not picking it up and I wonder with some of these Lyme like syndromes that people have where their ELISAs are negative and the Western Blots are negative, whether these are other sensu lato species we’re dealing with and B miyamotoi relapsing fever, for me because they found up to 10 to 20% of the ticks in Northeast in our area containing B miyamotoi and up to 10% in other areas in the US, for me it’s a gap just because the GlpQ picks it up later in the illness. I don’t think a lot of docs think about using PCR as early on. So you know for me I think all the points you brought up are great on prevention, on diagnostics, on NGS, looking also at Mycoplasma. I do see it. We just had a pregnant woman who gave birth. The Mycoplasma PCR was positive in the amniotic fluid after being on the Zithromax during her entire pregnancy. But I am concerned about Powassan with the study that just came out where 9.4% of the people in the Northeast were exposed to it. My concern is you’re right about what is high impact and what is getting people Anaplasma Ehrlichia, but if people should start dropping from Powassan, they’re going to come to our committee and they’re going to say, “Why didn’t you...” I mean it’s very tough, because there are so many good questions to bring up. So I’ve been kind of taking a tally and it’s... You know I think we do have a lot of topics. Rich and Alan, how do we narrow it down at this point to the five? Because I have been keeping a tally of what everyone has been talking about.
Dr. Richards: Well, I would...
Male: Yeah, Rich, can you hear me?
Dr. Richards: I was just thinking about that as well. If you sort of lump the Lyme co-infections as one topic, then diagnosis of tick-borne diseases and co-infections, vaccines against ticks, tick-borne viruses, and tick-borne bacteria is just my quick grouping.
Dr. Munderloh: This is Ulie Munderloh. May I just say, remember in the very first part of the entire group meeting there was a question or an item where we should look at the things that we can do now or in the near future and what may be things to think about that can be more income passing ways of dealing with tick-borne infections that would be, you know, will take a long time yet to develop and I think that from a physician standpoint, clearly they want to treat patients with what they’ve been diagnosed with and so I think it makes sense to on the one hand focus...take a disease, a pathogen-focused view and on the other hand to take a prevention view like Sam had said, even though it’s not entirely really clear what can be done productively there and so I think that would be one of those for the future. One thing, I saw a veterinarian, you know, there are tick-borne pathogens in animals, particularly livestock or also wild animals are really having a problem for much longer or recognized than actually with people and so there are...and the veterinarians have thought about preventing, you know coming up with vaccines against tick saliva and so on and none have worked and in fact, tick saliva or mosquito or other parts of saliva vaccines have often took the opposite effect that they make things worse and ticks have co-evolved to outsmart the immune response for animals for a week or more for such a long time that coming up with a vaccine against tick bites or tick saliva I think that’s really, really a future thing. So that’s where I would put it and then of course, there are other approaches that people are actively looking at is by prevent...making ticks into something less dangerous namely by preventing them from acquiring and maintaining pathogens and people are looking at that with other arthropods and what’s called the para-trans-clinic approaches or trans-clinic approaches, that the ticks or their symbiotic microbes are manipulated to provide a ways to prevent the tick from acquiring or maintaining pathogens. So I would put that out for...into future approach, but something that we should definitely look at. So like I would take the pathogen specific approach as treat the diseases with all this aspects of illness, killing the pathogen, and alleviating the symptoms - anti-inflammatory approaches, for example - and then also looking at ways to prevent ticks from being pathogen vector.
Dr. Horowitz: Great. So we’re getting... And I guess we’re going to have to probably do this a little by email or call again just to kind of narrow this down, but the next thing that we need to do before we get back to the committee is on the inventory suggested additions or subtractions for the document for HHS and DOD. We won’t have time to go through...just in the timing, because I think we have to come back in around 10 minutes or so, 12 minutes. Uh, I looked it over and you may... Please everybody, I would just kind of kick in here, I was looking at it and the things that I looked at is I would like to know what the questionnaire and the comparison of relative spending for other diseases like Zika getting 1.1 billion in research. Lyme research and other tick-borne 25 million, just to compare the disease burden. When I looked at the co-infections, they had research money for relapsing fever, but I mean there’s the soft body ticks; there’s the hard bodied ticks with relapsing fever. There’s all the different relapsing fevers. There is no Q fever that was on there. They didn’t have other Rickettsial organisms like parkerii and helvetica. For Babesia there’s some WA-1 (duncani) and microti. We are certainly seeing, you know, both types. Bartonella was not on there and then there’s other questions like other parasitic infections, because in both the Ixodes and the Ambalama ticks they’re finding other parasitic infections like filariasis and nobody knows whether it’s transmitted, but it’s an interesting question, because I do have patients that respond to anti-parasitics and I have no idea why. It is not a Babesia pathogens. So when I was looking through it those were the things I noticed. Please somebody jump in here. When you looked at the boxes there, what would you like to see expanded out?
Dr. Green: Well...
Dr. Telford: Well, I’d be careful about comparing numbers between all those, because you know when you look at Zika and try to justify... You know you can justify the expenditures there because that was a public health emergency based upon the possibility of epidemics due to mosquitoes in very densely populated areas in the South versus something which is much more chronic and endemic and long-standing. The populations at risk need to be defined if you’re going to...if we’re going to do this numerically and so I wouldn’t get outraged that one disease is getting more money than another and in fact, the way NIH looks at it, it’s all scientific merit. People are not... The reviewers aren’t even supposed to consider how many infections a disease causes. They look at the science and how good the science is and so we can’t look at something as simple as, “How much money is being spent?” but we have to realize there are nuances to that.
Dr. Horowitz: And do you have any other suggestions as far as the other tick-borne co-infections that might’ve been left off the list?
Dr. Telford: No. I think a main message we have to put out is, no tick bite is a good tick bite. (Chuckle.) It doesn’t matter. We can make huge lists of agents, but until they actually infect people, uh, burden people as much as Anaplasma or Rocky Mountain spotted fever do, uh, you know we have plenty to argue for reasons to prevent. Lyme disease alone is reason to prevent. We just spend lots of money on prevention.
Dr. Horowitz: Okay. Anybody else have any other suggested additions or subtractions for the document that’s supposed to be sent to HHS?
Dr. Green: I did think clustering is closer.
Dr. Horowitz: Yeah, go ahead Chris.
Dr. Green: I was thinking that clustering as, if you will, tick-borne bacterial pathogens, tick-borne viral; I mean maybe then we can study the fact that no tick bite is a good tick bite. I also think there... You can think of burden as... You know Rocky Mountain spotted fever has a high chance of mortality early on, but if you look at the burden of a chronic infection over time, I do think you have to look at the money supplied to different things, because that’s very bad for this society to have people dropping out of the workforce and not able to be as productive or as creative as they otherwise would. So I don’t know how to look at that allotment of funds, but I think it is important to do.
Dr. Horowitz: Okay.
Dr. Telford: Well, WHO did that with, you know, the global burden of disease and defining the so-called disability adjusted life here as our dailies associated with disease conditions and that’s a rational way of looking at burden, but... And so that would certainly capture the effects of continuing infection or re-exposure or so-called chronic infection just as much... You know, you can compare it that way with death due to...sudden death due to carditis, Lyme carditis or carditis due to deer tick virus.
Dr. Green: Right.
Dr. Paddock: So actually, Rich and Al, could... In terms of our mandate and sort of the...who this document...well, the working group document is directed towards, is it directed towards Congress and is the idea to sort of steer them in a direction to or recommendations for enhanced funding for specific, areas of investigation on tick-borne diseases? Is that the ultimate goal? Because I think for me, you know, if we’re going to pay five diseases or five topics, that’s like the most important thing, one of the most important things that we decide on. But I really don’t know who our audience is, so...or who our stakeholders are. You know maybe that was...
Male: The report is a report to Congress.
Dr. Paddock: ...articulated much more clearly and I didn’t pick up on it, but does anybody... Can anybody help me there?
Dr. Richards: Yeah this is Al. I think it is Congress, but Congress is trying to be, I think, efficient at this by looking at what resources they already have in the Health and Human Services and seeing what...having a bunch of experts look at what they have been doing in the past years and seeing if there are gaps in what they’re doing of certain diseases or a combination of diseases and should we be going, as Sam says, to treatments, I mean to vaccinations or should we be spending our time on treatments or identifications. So that’s our mandate. Our job is to try and identify what has been done and what still needs to be done. And so those six different subcommittees are addressing everything about tick-borne diseases and we’re involved in the “other tick-borne diseases and co-infections.” Does that help?
Dr. Paddock: Yeah. Yeah. Thank you.
Dr. Perdue: Yeah. So Chris, this is Sam. Having been doing this a long time as you have been and I don’t know how this will ultimately pan out, but the way these things often pan out, it’s certainly...from NIH’s perspective it is very rare for Congress to say, “You need to spend this much money on this,” unless they do a particular appropriate or appropriation. That doesn’t tend to happen. So what these things usually are is they’re informative of Congress and what they do is they kind of keep Congress aware of what the gaps are and basically fund that demand downstream reports on how well we’re meeting our mission and how well we’re filling those gaps. So I think of it as...
Dr. Wolitski: This is Rich. I mean it...
Dr. Perdue: ...being largely informative more so than for them, you know, obviously tied to any future dollars. I could be wrong, but I’m just guessing.
Dr. Wolitski: It may be the case for NIH, but I mean for other agencies...
Dr. Perdue: We can’t hear you.
Dr. Wolitski: You can’t hear me. That’s a problem. I’ll just type it then. I don’t know what to do.
Dr. Perdue: Did we lose Rich? We still can’t hear you, Rich.
Dr. Wolitski: Yeah. I’m here; you can’t hear me.
Dr. Horowitz: I put up the volume and I can hear you now.
Dr. Wolitski: Okay. Great. So as I said before, either agencies, other than NIH, there often is set aside funding or directives given to agencies to allocate certain amount of money or to take on X, Y, and Z activities.
Dr. Horowitz: I can hardly hear him when I can hear him.
Dr. Wolitski: Okay. So there’s nothing I can do on this end to fix that.
Dr. Horowitz: Richard, if you can hear us, call back in. Call back in.
Dr. Wolitski: Okay.
(The following conversation is difficult to hear and loud background noise - 00:57:05.)
Dr. Horowitz: There we go. Yeah, Rich. So please feel free to call back in. So we did go though the inventory. Does anyone then otherwise any suggestions, additions, or subtractions or do you think it’s okay the document the way it is? I mean I just want for them to break down the categories. Like for example, as we said, Bartonella was not on there.
Operator: Pardon the interruption. This is your two-minute warning.
Dr. Horowitz: I would be interested in and when it says Rickettsia to breakdown what type of Rickettsia they’re studying, how much research is on soft body ticks versus hard bodied. So that’s how I was looking at it, but again, this is for all of us, right. Any other suggestions?
Dr. Munderloh: Could you elaborate on the Mycoplasma?
Dr. Telford: Could you go over your list again so that we can get an idea of what you’ve got on the list?
Dr. Horowitz: You mean as far as what was... Well, have you read the document that was sent? Did you all receive the document that goes to the DOD and the HHS?
Dr. Munderloh: The draft HHS. Yeah, the draft ones. Yes.
Dr. Horowitz: Yeah. So...
Dr. Green: The one where you check the different boxes?
Dr. Horowitz: That’s it. That’s the one with the boxes to see whether we thought that they were missing anything on that document or did we want to take things off? That was mainly the question.
Dr. Green: There aren’t a lot of co-infections named on that document.
Dr. Munderloh: No, but you can pick several and say they will be important in co-infections. So one thing about the check boxes that list the pathogens, how important is Colorado tick fever still? I do not have a good feeling for that one at all.
Dr. Paddock: It’s not studied a whole lot. (Laughter.)
Dr. Munderloh: Yeah.
Dr. Paddock: We don’t know and I mean, you know, in terms of other tick-borne arboviruses, there’s no heartland. There’s no bourbon virus there and I think, as Rich mentioned, you know many of the other Rickettsioses aren’t listed, including a Rickettsia-parkeri and Rickettsia-364D. And then you know, Babesiosis, again, there’s different species of Babesia, so I... You know they don’t necessarily all behave identically. We could really expand this, but then again, you know, I don’t know if that’s what they’re asking of us.
Dr. Horowitz: My sense is just I thought they were just basically asking, “Is it a complete document or anything we...” So for example, Bartonella was not on there. They talked about Rickettsial, but there was nothing for Q fever, Coxiella burnetii which I do pick up from time to time in the practice and since it’s also a bio-terrorist agent I thought, “Well, maybe that’s a good one to put separately.”
Dr. Paddock: Yeah, it’s... I mean it’s in our group of pathogens here at CDC, but it’s not typically tick-borne. It’s more of an aerosol transmitted agent, even though you can find it in ticks, but ticks are believed to be an uncommon source of transmission. I would just say, just in general, that, you know, this is an incomplete list of tick-borne diseases by far.
Dr. Telford: But I don’t think that was the intent to the survey. The survey is to show what kind of resources and what kind of projects are being done and if you lump all of Babesia’s into Babesiosis, that’s perfectly okay, because otherwise you’re going to have a large list of zeros. Again, presenting this idea that, “Well, nothing’s being done, when in fact an aggregate Babesiosis or Rickettsiosis or Ehrlichiosis, uh, if you don’t break them up into separate species and you know there’s really no... Clinically you certainly wouldn’t. Uh, I don’t see what the merit is in making people for these surveys actually distinguish between Babesia microti and Babesia duncani. We can provide in a summary somewhere, “Well, here’s a table of all of the...” - you and I did this, Chris - “...of all the possible tick-borne pathogens in the United States and whether they’re common, sort of common, or rare,” and that might be useful to others in the larger working group.
Dr. Horowitz: Sure. Yeah. I think... You know if we’re going to lump or... You know the question is lump or split and if we’re going to lump then it would be Rickettsiosis rather than Rocky Mountain spotted fever. You know we would talk about tick-borne arboviruses rather than Powassan or Colorado tick fever or heartland virus, you know. So I think the devils in the details. I...
Dr. Munderloh: Yeah, maybe we could come back also again to the...what we can do now and what we can...should focus on in the future and I’ll pick one, say Powassan disease. Coming from Germany, I’m from three generations who was never vaccinated against the tick-borne encephalitis virus there, but I was obviously infected one point and never knew about. I was later shown that I have a history of infection and one could say we could use that tick-borne encephalitis vaccine, that it’s really successful in Europe and tran-start maybe and inform an approach in the U.S. that would develop a vaccine against Powassan disease, because...not because it is so very prevalent now, but it shows signs of significant increase and it is a high risk infection that would make such an approach and we have this, you know, ability to learn and take guidance from the European model.
Operator: Pardon the interruption. You are now being transferred.
Dr. Munderloh: Would that be something?
(Silence and end of Breakout Session 6 - 01:03:48 to 01:05:21.)
