Tick-Borne Disease Working Group Virtual Meeting 24 Summary - Day 1

October 24, 2022

Note: For context and clarity, speaker credentials will be included upon first mention in each meeting’s summary. Subsequently, individuals will be referenced by their first names to equalize expertise across the many diverse disciplines represented in this document. All perspectives and expertise, including patient-lived experience, is valued equally. Speaking on a first-name basis helps the Tick-Borne Disease Working Group ensure that all voices are heard and valued based on merit and without the bias of titles, eminence, or prestige.

Welcome and Roll Call: Day 1

James (Jim) Berger, MS, MT (ASCP) SBB, Senior Blood and Tissue Policy Advisor, Office of Infectious Disease and HIV/AIDS Policy (OIDP), Office of the Assistant Secretary for Health (OASH), U.S. Department of Health and Human Services (HHS); Designated Federal Officer for the Tick-Borne Disease Working Group, called the meeting to order and conducted the roll call (see Appendix 1: Tick-Borne Disease Working Group Members and HHS Support Staff). The meeting began with a quorum.

Recap of Meeting 23 and Meeting 24 Goals

Holiday Goodreau, Executive Director, LivLyme Foundation; Co-creator, TickTracker; Working Group Co-Chair, presented a recap of Meeting 23. The agenda for that meeting was as follows:

• Voted on Order of Chapters and Recommendations
• Discussed Chapter Comments and Voted
  • Tick Ecology, Personal Protection, Control (Discussed Comments and Voted)
  • Clinical Presentation and Pathogenesis (Discussed Comments and Voted)
  • Diagnostics (Discussed Comments and Voted)
  • Disease Prevention and Treatment (Discussed Comments)
  • Access to Care and Education (Discussed Comments)
• Discussed Progress Updates
  • Public Comment Chapter
  • Executive Summary, Introduction, Conclusion, and Looking Forward Chapters
• Discussed Unresolved Issues

Linden Hu, MD, Tufts University School of Medicine, Professor Microbiology and Medicine; Working Group Co-Chair, presented the objectives for Meeting 24, which included a discussion and votes on remaining chapters as well as a review of the timeline for the report preparation process. Linden presented the agenda for Day 1 of the October 24-25 meeting, which was as follows:

• Discuss and Vote on the Disease Prevention and Treatment Chapter
• Discussion and Vote on the Access to Care and Education Chapter
• National Inventory Update
• Unresolved Issues

Overview of the Working Group’s Mission Statement, Vision Statement, and Values

Jim reviewed the Working Group’s Mission Statement, as follows:

The Tick-Borne Disease Working Group’s mission, as mandated through the 21st Century Cures Act, is to provide expertise and to review all efforts within the Department of Health and Human Services related to all tick-borne diseases, to help ensure inter-agency coordination and minimize overlap, and to examine research priorities. As part of this mandate, and in order to provide expertise, we will ensure that the membership of the Working Group represents a diversity of scientific disciplines and views and is comprised of both Federal and non-Federal representatives, including patients, and family members or caregivers, advocates of non-profit organizations in the interest of the patient with tick-borne illness, scientists, and researchers. A major responsibility of our mission will be to develop and regularly update the action of HHS from the past, present, and the future.

Jim then reviewed the Working Group’s Vision Statement, as follows:

SHARED VISION: A nation free of tick-borne diseases where new infections are prevented, and patients have access to affordable care that restores health.

Finally, Jim gave an overview of the Working Group’s Core Values, the complete versions of which are provided below.

RESPECT: Everyone is valued

We respect all people, treating them and their diverse experiences and perspectives with dignity, courtesy, and openness, and ask only that those we encounter in this mission return the same favor to us. Differing viewpoints are encouraged, always, with the underlying assumption that inclusivity and diversity of minority views will only strengthen and improve the quality of our collective efforts in the long term.

INNOVATION: Shifting the paradigm, finding a better way

We strive to have an open mind and think out of the box. We keep what works and change what doesn’t. We will transform outdated paradigms, when necessary, in order to improve the health and quality of life of every American.

HONESTY and INTEGRITY: Find the truth, tell the truth

We are honest, civil, and ethical in our conduct, speech, and interactions with our colleagues and collaborators. We expect our people to be humble, but not reticent, and to question the status quo whenever the data and the evidence support such questions, to not manipulate facts and data to a particular end or agenda, and to acknowledge and speak the truth where we find it.

EXCELLENCE: Quality, real-world evidence underlies decision-making

We seek out rigorous, evidence-based, data-driven, and human-centered insights and innovations—including physician and patient experiences—that we believe are essential for scientific and medical breakthroughs. We foster an environment of excellence that strives to achieve the highest ethical and professional standards, and which values the development of everyone’s skills, knowledge, and experience.

COMPASSION: Finding solutions to relieve suffering

We listen carefully with compassion and an open heart in order to find solutions which relieve the suffering of others. We promise to work tirelessly to serve the greater good until that goal is achieved.

COLLABORATION: Work with citizens and patients as partners

The best results and outcomes won’t be created behind closed doors but will be co-created in the open with input of the American public working together with these core values as our guide. We actively listen to the patient experiences shared with us, respect the lived experiences of patients and their advocates, and learn from their experiences in our pursuit of objective truth. Across diverse audiences, we communicate effectively and collaborate extensively to identify shared goals and leverage resources for maximum public health impact.

ACCOUNTABILITY: The buck stops here

We, as diligent stewards of the public trust and the funds provided by our fellow citizens, pledge to be transparent in all of our proceedings and to honor our commitments to ourselves and others, while taking full responsibility for our actions in service to American people.

Objectives

Jim reviewed the Working Group’s objectives, which are to provide expertise and review all efforts within HHS related to all tick-borne diseases, to help ensure interagency coordination and minimize overlap, and to examine research priorities. He outlined the Working Group’s duties, as follows:

1. No later than two years after the date of enactment of the authorizing legislation, review a summary of:
   1. Ongoing tick-borne disease research, including research related to causes, prevention, treatment, surveillance, diagnosis, diagnostics, duration of illness, and intervention;
   2. Advances made pursuant to such research;
   3. Federal activities related to tick-borne diseases, including (a) epidemiological activities related to tick-borne diseases and (b) basic, clinical, and translational tick-borne disease research related to the pathogenesis, prevention, diagnosis, and treatment of tick-borne diseases;
   4. Gaps in tick-borne disease research described in clause 3b;
   5. The Working Group’s meetings; and
   6. The comments received by the Working Group.
2. Make recommendations to the Secretary regarding any appropriate changes or improvements to such activities and research.
3. Solicit input from States, localities, and non-governmental entities, including organizations representing patients, health care providers, researchers, and industry regarding scientific advances, research questions, surveillance activities, and emerging strains and species of pathogenic organisms.

Disease Prevention and Treatment Chapter Review

Holiday opened the discussion of individual chapters and member feedback by explaining that each member would explain their comment in the manuscript, as well as any recommended revisions. Chapter authors would then have an opportunity to respond. Subsequently, Working Group members would be able to discuss each comment. Cat Thomson, RLA contractor, was present to display chapter manuscript and member comments on screen and record Working Group decisions made to address each comment.

The Working Group reviewed new items at the beginning of the report, including a finalized graphics and rationales for the chapter recommendations. Cat explained that the graphic had been updated based on discussions from the previous meeting.

Comment 1 from Betty Maloney

Elizabeth (Betty) Maloney, MD, President, Partnership for Tick-borne Diseases Education, commented that the wording in the rationale for the third recommendation may not be inclusive of patients who do not present until their disease is significantly advanced. Sunil K. Sood, MD, Chair of Pediatrics, South Shore University Hospital, Attending Physician, Infectious Diseases, Cohen Children’s Medical Center, Professor of Pediatrics at Hofstra/Northwell, recommended simply taking the wording out. Betty agreed.

Comment 2 from Linden Hu

Linden expressed concern about a graphic portraying anti-tick vaccines, noting that the examples presented were disease-specific. Sunil recommended moving the examples of specific tick vaccines to a different graphic. Kirby C. Stafford III, PhD, Chief Scientist and State Entomologist, Department of Entomology, Center for Vector Biology & Zoonotic Diseases, The Connecticut Agricultural Experiment Station, noted that he had also commented on this section, stating that he expected examples. Charles Benjamin (Ben) Beard, PhD, Deputy Director, Division of Vector-borne Diseases, Centers for Disease Control and Prevention (CDC), recommended a rewording to “anti-pathogen” for clarification. Monica E. Embers, PhD, Associate Professor and Director of Vector-borne Disease Research, Tulane National Primate Research Center, noted that the goal was to be more inclusive of the different vectors, but agreed with Sunil to simply take out the examples and frame the graphic as anti-pathogen.

Jennifer Platt, DrPH, Co-founder, Tick-borne Conditions, added that a caption could be placed under the graphic to direct the reader to the Changing Dynamics of Tick Ecology, Personal Protection, and Control chapter, which also describes prevention efforts. Sunil noted that the graphic would be placed above a summary near the end of the chapter. Kirby stated that the passage before the graphic should reference other tick-borne illnesses, including Alpha-gal Syndrome (AGS). The Working Group agreed to add language directing the reader to the Tick Ecology chapter.

Comment 3 from Betty Maloney

In her comment, Betty recommended adding an additional reference to a passage. Sunil agreed with the addition. She also recommended adding an additional reference to an adjoining passage. Monica suggested adjusting the wording in the passage to more accurately describe the findings in the first study recommended by Betty. Sunil and Betty agreed that portraying the findings as significant was acceptable to both of them.

Dennis Dixon, PhD, Chief, Bacteriology and Mycology Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), HHS, suggested that the specific percentages of patients who remained ill from Betty’s proposed second reference be added to the passage. Jennifer requested that additional percentages from the study be provided in the passage to describe functional impairments patients experienced as the result of disease. Dennis inquired if these impairments were due to chronic or acute disease; Betty was unsure and indicated she would locate and present the accurate information later in the meeting.

Comment 4 from Betty Maloney

Cat noted that the addition to the passage was added during the previous meeting, but it did not address Betty’s comment. Betty noted that she was under the impression that the Working Group had agreed to specific language portraying the clinical trials—and that the new language was misleading. She requested that the passage be reverted to the previously agreed upon language. Sunil observed that Betty had added an additional reference and agreed to the addition. Gabriella (Gaby) Zollner (Romero), PhD, Program Manager, Deployed Warfighter Protection Program, U.S. Department of Defense (DoD), suggested that the reference be added to the chapter reference list, as well.

Comment 5 from Betty Maloney

In Betty’s comment, she noted that Dennis had inquired about how symptoms were portrayed in a particular study. Betty stated that she was also unable to determine the character of the symptoms. Sunil, Dennis, and Betty agreed to keep the language vague in order to avoid inaccuracy.

Vote

Betty proposed a motion for the Working Group to accept the chapter. Thirteen members voted yes. One member was absent. The motion passed.

National Inventory Update

Meghan Walsh, PhD, Deputy Director, Division of Scientific Research & Development, Rose Li & Associates, Inc., presented an update on the 2022 National Inventory of Tick-Borne Diseases and Associated Illnesses.

Objectives

The objectives of the Inventory are as follows:

• Expand the breadth and depth of the Federal Inventory to include additional survey components and a scan of the literature
• Quantify tick-borne disease programs, activities, and funding at the federal and state levels, and within relevant private organizations
• Identify advances, overlaps, challenges and gaps in tick-borne disease research in the United States
• Provide a companion report to the Tick-Borne Disease Working Group Report to Congress concerning progress across the national tick-borne disease landscape

Literature Review

Meghan explained that the tasks of the Inventory were to redevelop the Federal Agency survey, to develop surveys for states and private organizations, and to conduct a broad scoping review of published and unpublished literature.

Methods to produce the scoping review included several exclusion criteria. These exclusion criteria include studies published outside the United States, studies exclusive to flea-borne disease, tick-borne disease in animals, and clinical trials that were terminated. The literature review employed Arksey and O’Malley’s scoping framework and included studies from January 1, 2018, to June 30, 2022. Over 1500 articles were identified for the review, which ultimately included analysis of 443 articles. Meghan noted that the volume of tick-borne disease studies is increasing and is expected to continue on this trajectory in 2022. 

The themes of articles chosen for the review encompass several topics related to tick-borne diseases and associated illnesses. More than 31 percent of the publications involved diagnosis of tick-borne diseases; 29 percent focused on human disease surveillance; 12 percent discussed diagnostics and prevention; and 8 percent discussed tick surveillance. Numerous tick-borne diseases were covered in the published articles; however, Lyme disease was the focus of the vast majority.

Meghan reported on the primary findings of the scoping literature review, as follows:

• Tick-borne disease research is increasing but gaps remain
• Additional public and clinician education is needed even among individuals who are aware of the risks
• Unpublished research highlighted emerging work in:
  • Tick-borne disease educational intervention methods
  • Tick surveillance technologies and vaccine development

National Surveys

The 2022 National Inventory surveys were adapted from the Working Group’s Federal Inventory agency survey used in 2018 and 2020 cycles. Additional survey questions were derived from the 2022 Working Group subcommittee priority findings. Meghan explained that surveys were tailored for each group (federal, state, and private funding organizations) and were designed to collect information on programs, activities, funding, staffing, and future plans related to tick-borne disease and associated illnesses.

Federal Agency Survey

Meghan provided details of the survey for federal agencies. CDC, NIH, and DoD reported funding increases to study tick-borne diseases. NIH reported the largest increase in funding, while funding at the U.S. Department of Agriculture (USDA) has declined slightly since 2018.  The U.S. Food & Drug Administration (FDA) was the only agency to report no dedicated funding for tick-borne diseases from 2018 to 2021.

All agencies reported engaging in tick bite prevention and control measures. However, no agencies reported the adoption of programs related to mental health services or related supported services. Federal agencies’ largest areas of focus were epidemiology and prevention.

Overall, the survey results demonstrate these findings:

• CDC was the only agency to indicate work on equity related to tick-borne diseases and associated illnesses
• All agencies reported engaging in activities to increase adoption of tick-borne disease prevention and control methods
• Only CDC reported programs related to educating the public and healthcare providers
• No agency reported identifying or implementing solutions that streamline the regulatory pathway for getting new tick-borne disease diagnostic offerings to market
• CDC, NIH, DoD, and FDA all plan to increase staffing to support tick-borne disease programming, activities, and research

State Surveys

The National Inventory also includes surveys conducted in several states. Nine states were selected to be surveyed and five states participated in the survey: Maine, New Jersey, New York, Pennsylvania, and West Virginia. Meghan noted that the lower response rate may have been due to a limited response time and the time of year (i.e., summer) during which the surveys were conducted. Additionally, state resources were limited due to the monkeypox outbreak.

Funding allocations showed that Pennsylvania dedicated the largest amount of funding for tick-borne diseases. Pennsylvania’s state legislature and governor prioritized funding for Lyme disease in 2018-2021. There was no clear trend in funding levels across other states. New Jersey, Pennsylvania, and West Virginia reported increases in funding, while New York reported a decrease. States dedicated funds to a variety of programs, and all five states reported conducting vector surveillance for tick-borne diseases. Four states conducted and reported surveillance of tick-borne infections. The programs with the highest levels of funding included tick ecology, personal protection and control, and disease prevention and treatment.

All states indicated that they had some programs directed at high-risk groups. State prevention and control programs primarily focused on children. No state activities focused on communities of lower economic status, pregnant people, or indigenous communities. State research efforts varied; some states did not have dedicated research programs. None indicated initiatives directed at solutions to streamline regulatory pathways to facilitate bringing products to market. The most prominent research themes reported by states were coinfections and vector control. Regarding future plans, several states reported that they will prioritize general education on tick-borne diseases, while others plan to focus on personal protection, diagnostics, employer education, and disease prevention.

The state survey also incorporates data from other sources. Information from annual reports from the following ten states were included: California, Maine, Massachusetts, Minnesota, New Hampshire, North Carolina, North Dakota, Oregon, Ohio, and Vermont. Nine out of ten states reported activities or programs in areas of surveillance, epidemiology, and public education. All states focused on Lyme disease, spotted fever rickettsioses, ehrlichiosis, and anaplasmosis. West Virginia plans to add AGS as reportable illness in the future. The survey also included information from the National Association of County and City Health Officials (NACCHO), which produce a report on tick surveillance and control actions of various states. California, Illinois, and Ohio reported the most tick surveillance programs; however, many other states reported few or no tick surveillance or control programs.

Overall, the state survey results were as follows:

• All responding states reported conducting human and vector surveillance as well as local and regional surveillance and reporting of tick-borne diseases
• Most respondents indicated some focus on both public and clinical education as well as prevention programs
• All states reported funding or conducting programs and/or activities in public/clinician education, epidemiology, and prevention

Surveys of Private Organizations

Meghan reported that seven out of eight private organizations responded to the National Inventory survey regarding their tick-borne disease funding and programs. All respondents reported decreases in funding from 2018 through 2021. Three organizations reported that this decrease was due to the effects of the COVID-19 pandemic. However, all organizations expected funding to increase in 2022 and beyond.

Private organizations conducted a variety of programs related to tick-borne diseases and associated illnesses. Areas with the highest degree of focus were public education, clinician education, epidemiology, and prevention. No private organizations reported conducting or funding programs related to mental health services. Six organizations supported programs that expand knowledge and increase prevention capacity using methods such as crowdsourcing, citizen science, public service announcements, tick distribution mapping, and app development.

Respondents to the private organization survey reported their focus on specific tick-borne diseases. The highest focus was on Lyme disease, followed by babesiosis and Powassan virus. Three private organizations reported AGS as a focus. No organizations reported work on ehrlichiosis, anaplasmosis, or bartonellosis. Private organizations reported that the primary high-risk groups they focused on were children and high-risk workers. Some reported focus on groups with lower socioeconomic status.

Due to interest from the Working Group in helping bring new technologies to market to address tick-borne disease, private organizations were also surveyed to determine their involvement in this area. Two organizations fund programs that prioritize bringing tick bite prevention/control products to market, three fund programs that facilitate the commercialization of tick-borne disease intervention products, and five fund the promotion, evaluation, and development of current and new diagnostic approaches. Focus areas for commercialization of new products were diagnostics, coinfections, and treatments. Survey respondents indicated that they plan to focus on education, treatment, diagnostics, access to care, and disease prevention, among other topics, in the future.

Overall results from the surveys of private organizations were as follows:

• Private organizations were overwhelmingly funding activities related to Lyme disease and babesiosis
• No private organizations reported providing support for many tick-associated illnesses and coinfections such as tick-borne relapsing fever, ehrlichiosis, anaplasmosis, or bartonellosis
• More than half of the private organizations provided funding capacity for health equity with a particular focus on children and at-risk workers

National Inventory Overall Findings

Meghan reported on a few overall findings from the federal, state, and private organization surveys. She noted that tick-borne disease research is steadily increasing but unequally focused—focus is primarily on surveillance, diagnosis, and diagnostics—mainly on Lyme disease. Research related to access to care and disease burden, particularly among underserved communities and at-risk populations, is inadequate. Increased access to education for patients and health care providers would increase diagnostic accuracy, improve access to care, and potentially reduce hospitalization rates and costs associated with tick-borne diseases and associated illnesses. Enhanced education and prevention programming targeted at high-risk groups and vulnerable populations could reduce the overall disease. Meghan noted that a full catalog of published articles from the literature review was attached to the National Inventory report.

Regarding health equity, children were the primary focus of state programs. Other vulnerable populations were underrepresented, such as high-risk workers and immigrant populations. While a majority of private organizations have funded research with health equity incorporated into their design, 43% have not. Gaps were identified in federal agency activities regarding vulnerable and high-risk populations. To ensure appropriate evaluation, the National Inventory writers recommend that health equity must be woven into the planning and execution stages of all tick-borne disease activities, including research, surveillance, prevention, diagnosis, and treatment.

Meghan also reported findings from the National Inventory on regional disparities. She explained that state sample size was small and chosen based on the incidence of tick-borne disease and funding; therefore, findings are skewed toward states with the most capacity to devote resources to tick-borne diseases and associated illnesses. Based on all state data sources, wide disparity exists in program capacity across states and regions. No standardized approach exists to determine gaps or measure state tick-borne disease performance. Thus, further investigation to quantify and characterize state gaps is warranted.

The National Inventory findings provide some suggestions for future work in this area. These include:

• A future inventory with a broadened review of literature scope to include international programs, activities, and research to report on successful initiatives and programs in other countries
• A national survey of states would generate a better understanding of interstate differences, establish a national baseline to measure progress, draw informed conclusions, and target initiatives for underserved states and regions
• The development of a tick-borne disease “roadmap” for states with measurable performance indicators to track progress would allow states to compare their performance against others and within states across time

Overall, findings in the National Inventory suggest that considerable work is occurring across federal agencies and states, through private organization efforts, and in various research fields regarding tick-borne diseases and associated illnesses. However, considerable gaps remain in areas of research particularly across diseases, and disparities exist in programming and funding nationally. More work is needed to expand the knowledge base and ensure equitable access to care and programs.

Discussion

Monica observed that in the arena of federal spending, the National Inventory combines diagnostics and therapeutics, yet in reality, most of the investment focus is on diagnostics; she noted the Inventory could be improved by separating the federal spending on diagnostics and therapeutics to make this disparity more apparent. Monica also noted that the inventory combines state support for prevention and treatment; however, most of this funding likely goes to prevention efforts. She noted that federal funding for tick-borne disease and pregnancy was nonexistent. Additionally, Monica pointed out a contradiction in the presentation: one of the slides indicated that no private organizations supported programs related to mental health, but the accompanying figure showed some activity in this area. In response to Monica’s first comment, Meghan noted that survey questions could be written in the future to obtain more specific information.

Jennifer inquired about 266 articles cited in the literature review that were not included in the Working Group’s 2022 Report to Congress. Meghan invited the Working Group to review the catalog of literature. Betty and Jennifer commented that the Inventory would have been useful earlier in the Working Group process. Betty inquired if there would be less of a gap between literature cited in the Working Group report and the National Inventory if unpublished materials had been excluded. Meghan responded that most of the literature cited in the Inventory was published. Betty questioned the statistic on deaths caused by Powassan virus and stated that she would investigate.

Inquiring about future directions, Betty asked who would conduct the next National Inventory, should there be one. Meghan noted that a national-scale inventory in this field is new and represents a pilot project that could serve as a model for future endeavors. Jennifer recommended highlighting the Inventory in the Conclusion of the Working Group report to draw attention to the gaps in health equity research identified in the Inventory.

Access to Care and Education Recommendations Review

Linden opened the discussion with a review of the first recommendation in the chapter. The revised recommendation read as follows:

Provide funding for the U.S. Department of Health and Human Services (DHHS) to sponsor a Federal Advisory Committee (FAC) utilizing subject matter experts, including public stakeholders, to conduct a comprehensive review of the basic science and clinical evidence of Lyme disease.

Betty explained the intentions of the revised first recommendation. She stated that there are continued conflicts among scientists and advocates over the facts. She advocated for a new federal advisory committee to provide an agnostic scientific review. Betty also highlighted the significant concerns from the patient advocacy community, which seeks an opportunity to be heard. She stated that the scope does not have to be as broad as the current iteration of the Working Group. Betty stated that a new FAC would not have to consume as much time and energy of the federal members. Jennifer inquired if a scientific review would cover literature reviewed by the National Inventory and the Working Group report; Betty responded affirmatively and noted that older studies need to be reinvestigated to understand their results. Monica asked if the goals of this new FAC were to review the literature and provide opportunities for public comment throughout the process. Betty replied that the new FAC was not intended to make recommendations, but rather to review the scientific literature and clinical evidence.

Ben expressed concern about the recommendation, stating that the proposed FAC would not function as FAC typically functions (by making recommendations). He proposed an HHS-sponsored workshop with public involvement, possibly a symposium sponsored by the National Academies of Science Engineering and Medicine (NASEM)—specifically the National Academy of Medicine (NAM), formerly the Institute of Medicine (IOM). He noted that HHS could provide funding for such an endeavor. He said he would support a recommendation framed this way.

Betty asked if an FAC was required to make recommendations. Jim noted that FACs typically make recommendations, but the charter determines the nature of those recommendations. Kaye Hayes, MPA, Alternate Designated Federal Officer, Tick-Borne Disease Working Group, Deputy Assistant Secretary, OIDP, OASH, HHS, responded that providing advice is an inherent aspect of an FAC. Betty noted that the proposed FAC would give advice on the findings of their scientific review. Kaye responded that the charter would need specify this role.

Holiday acknowledged that HHS would write the charter for the proposed FAC; non-federal members would have no part in that process. Betty suggested writing a charter for HHS to potentially adopt. She recognized that IOM is a respected institution and expressed openness to the idea of conducting a scientific review with this organization, provided there was an inclusive representation of stakeholders from the research and advocacy communities. Dennis commented that this review potentially distracts from new research to better understand the pathogenesis of tick-borne diseases.

The Working Group considered the NAM as a possible alternative venue to an FAC to conduct the scientific review Betty proposed. Ben stated that rigorously reviewing a scientific topic with varying viewpoints on a particular topic is the specialty of NAM; he reiterated that he would support a recommendation for HHS to sponsor an NAM workshop that provided opportunities for public input and identified gaps in the science. Linden inquired if the meetings would be public and what the end product of the workshop would be. Ben confirmed the meetings are usually public, and the panelists typically release a report as a work product. Monica expressed support for the NAM workshop idea and asked how panelists would be decided. Ben acknowledged that NASEM appoints panelists but takes recommendations from outside institutions. He provided a link to the Working Group on how to nominate potential panelists. Leith Jason States, MD, MPH (FMF), Deputy Chief Medical Officer, OASH, HHS, noted that HHS does not need to sponsor the NASEM committee, adding that the NASEM scientific board will use a transparent and neutral process to plan and staff the proposed workshop.

Betty expressed apprehension about the proposed NASEM workshop, noting that her experience at a 2010 workshop presented (in her view) a biased opinion of the field of tick-borne disease. Linden asked if a NASEM workshop would look at treatment guidelines, given the urgency of the need for patients. Ben was uncertain; but a workshop could identify care strategies that are effective. Linden expressed concern about supporting the recommendation for an FAC, as written, because it might be too narrow. Rebecca shared the sentiment that patients need support quickly, and she did not want to delay action.

Vote

Betty proposed a motion to accept the recommendation. Four members voted yes, seven voted no, and two abstained. One member was absent. The measure failed to pass.   

Revision of the First Recommendation

Betty proposed that the Working Group revise the recommendation as a NASEM workshop that Ben suggested. Ben offered to provide some revised language. Ben, Dennis, and Betty agreed to craft precise wording around studying clinical data, clinical practice, and clinical trial design.

Jennifer suggested that members who voted against the recommendation provide feedback on how a revised version could be improved to gain their support. Linden noted that his reason for voting against the recommendation was mainly the FAC mechanism itself; he stated that he had no objections with the intent and function of the recommendation, but preferred a different mechanism for it to proceed. Linden supported the idea of a NASEM workshop. Kirby agreed with Linden’s view and emphasized that public stakeholders should remain a key component of the revised recommendation.

Leith offered the Agency for Healthcare Research and Quality's (AHRQ) as an alternative to NASEM. He stated that AHRQ could provide a similar function to NASEM in a rigorous scientific review. Betty noted that she would need to have time to investigate AHRQ before approving this alternative. To allow more time for members to consider the revised recommendation, Linden proposed that the Working Group review the remainder of the chapter today, then hold a vote on Day 2 of this meeting. The Working Group agreed. Gaby provided information about NASEM to the Working Group to help with their consideration.

Review of the Second Recommendation

Ben explained that his edit to the second recommendation highlights two recommendations from the 2020 Working Group report (7.1 and 7.2) in order to emphasize the importance of reviewing websites and educational content for tick-borne diseases and associated illnesses. Betty supported the revisions.

Review of the Third Recommendation

Linden opened a discussion of the third recommendation, which had already been voted on and approved. His intention was to review the wording to ensure it did not overlap with the revisions of the other two chapter recommendations. Because both the second and third recommendations involve review of federal agency websites, Linden questioned if they overlapped. Betty noted that the third recommendation involves the review of material specific to Lyme disease. Linden suggested combining the two recommendations, but no decision was made by the Working Group during this meeting. Linden confirmed that the rationales for all three recommendations would remain unchanged. There were no objections from the Working Group.

Access to Care and Education Chapter Review

Linden suggested that Working Group review the remainder of the chapter while allowing time for the members to consider the recommendations separately overnight. Betty and Linden confirmed that the only comment (by Betty) was a request to ensure that AGS was mentioned in a particular graphic.

Vote

Monica proposed a motion to accept the chapter without recommendations. Thirteen members voted yes.  One member was absent. The motion passed.  

Adjournment

Linden thanked all the Working Group participants for their continued diligence in revising their chapters. Jim adjourned the meeting at 3:25 pm EDT.

Appendix 1: Tick-Borne Disease Working Group Members and HHS Support Staff

Tick-borne Disease Working Group

In alphabetical order:

Co-Chair

Holiday Goodreau, Executive Director, LivLyme Foundation, Co-creator, TickTracker (Present)

Co-Chair

Linden Hu, MD, Professor of Microbiology and Medicine, Tufts University School of Medicine (Present)

Charles Benjamin (Ben) Beard, PhD, Deputy Director, Division of Vector-borne Diseases, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services (Present)

CAPT Rebecca Bunnell, MPAS, PA-C, Senior Advisor, Learning and Diffusion Group, Center for Medicare & Medicaid Innovation, Centers for Medicare & Medicaid Services, U.S. Department of Health and Human Services (Present)

Dennis Dixon, PhD, Chief, Bacteriology and Mycology Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, U.S. Department of Health and Human Services (Present)

Monica E. Embers, PhD, Associate Professor and Director of Vector-borne Disease Research, Tulane National Primate Research Center (Present)

Elizabeth Maloney, MD, President, Partnership for Tick-borne Diseases Education (Present)

Robert J. Miller, PhD, National Program Leader, Agricultural Research Service, U.S. Department of Agriculture (Not Present)

CDR Todd Myers, PhD, HCLD (ABB), MB (ASCP), Office of Counterterrorism and Emerging Threats, Office of the Chief Scientist, Office of the Commissioner, U.S. Food and Drug Administration, U.S. Department of Health and Human Services (Present)

Jennifer Platt, DrPH, Co-founder, Tick-borne Conditions United (Present)

Sunil K. Sood, MD, Chair of Pediatrics, South Shore University Hospital, Attending Physician, Infectious Diseases, Cohen Children’s Medical Center, Professor of Pediatrics at Hofstra/Northwell (Present)

Kirby C. Stafford III, PhD, Chief Scientist and State Entomologist, Department of Entomology, Center for Vector Biology & Zoonotic Diseases, The Connecticut Agricultural Experiment Station (Present)

Leith Jason States, MD, MPH (FMF), Deputy Chief Medical Officer, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services (Present)

Gabriella Zollner (Romero), PhD, Program Manager, Deployed Warfighter Protection Program, U.S. Department of Defense (Present)

Alternative Federal Representatives

In alphabetical order:

Kristen Honey, PhD, PMP Executive Director of InnovationX, U.S. Department of Health and Human Services (Present)

RADM Estella Jones, DVM, U.S. Public Health Service, Deputy Director, OCTET U.S. Food and Drug Administration (Not Present)

Andrew Y. Li, PhD, Research Entomologist, Invasive Insect Biocontrol & Behavior Laboratory, U.S. Department of Agriculture (Not Present)

Samuel S. Perdue, PhD, Chief, Basic Sciences, Bacteriology and Mycology Branch at National Institutes of Health (Present)

CDR Monica Reed-Asante, PharmD, USPHS, Pharmacist, Senior Health Insurance Specialist for Centers for Medicare and Medicaid Services (Not Present)

LTC Michelle Colacicco-Mayhugh, PhD, PMP, Deputy Medical Entomology Consultant to the U.S. Army Surgeon General

HHS Support Staff

In alphabetical order:

James (Jim) Berger, MS, MT (ASCP) SBB, Designated Federal Officer, Tick-Borne Disease Working Group, Senior Blood and Tissue Policy Advisory, Office of Infectious Disease and HIV/AIDS Policy, U.S. Department of Health and Human Services

B. Kaye Hayes, MPA, Alternate Designated Federal Officer, Tick-Borne Disease Working Group, Deputy Assistant Secretary, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services

Chinedu Okeke, MD, MPH-TM, MPA, Senior Policy Advisor, Office of Infectious Disease and HIV/AIDS Policy, U.S. Department of Health and Human Services

Lauren Overman, MPH, CPH, Public Health Analyst, Office of Infectious Disease and HIV/AIDS Policy, U.S. Department of Health and Human Services

Allison Petkoff, Public Health Analyst, Office of Infectious Disease and HIV/AIDS Policy, U.S. Department of Health and Human Services

Appendix 2: Writing Groups for the 2022 Report to Congress and the HHS Secretary

(Chapter leads are underlined.)

Executive Summary—Linden Hu, Holiday Goodreau

Chapter 1: Introduction—Holiday Goodreau, Linden Hu, Ben Beard, Rebecca Bunnell, Monica Embers, Betty Maloney, Sam Perdue, Jennifer Platt, Leith States

Chapter 2: Methods—RLA 

Chapter 3: Changing Dynamics of Tick Ecology, Personal Protection, and Control—Robert Miller, Kirby Stafford, Michelle Colacicco-Mayhugh, Jennifer Platt, Gabriella Zollner (Romero)  

Chapter 4: Clinical Presentation and Pathogenesis—Ben Beard, Jennifer Platt, Leith States, Rebecca Bunnell, Monica Embers, Betty Maloney (resigned), Sunil Sood

Chapter 5: Diagnostics—Monica Embers, Todd Myers, Michelle Colacicco-Mayhugh

Chapter 6: Disease Prevention and Treatment—Dennis Dixon, Sunil Sood, Monica Embers, Sam Perdue, Jennifer Platt

Chapter 7: Access to Care and Education—Rebecca Bunnell, Betty Maloney, Leith States, Gabriella Zollner (Romero)

Chapter 8: Public Comment— Holiday Goodreau, Linden Hu, Lauren Overman, Jenifer Platt, Gabriella Zollner (Romero)

Chapter 9: Looking to the Future—Linden Hu, Holiday Goodreau

Chapter 10: Conclusions—Linden Hu, Holiday Goodreau