Tick-Borne Disease Working Group Virtual Meeting 23 Summary - Day 1

October 4th, 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, Office of the Assistant Secretary for Health, 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 roll call (see Appendix 1: Tick-Borne Disease Working Group Members and HHS Support Staff). The meeting began with a quorum.

Recap of Meeting 22 and Meeting 23 Goals

Linden Hu, MD, Tufts University School of Medicine, Professor Microbiology and Medicine; Working Group Co-Chair, presented a recap of Meeting 22. The agenda for that meeting was as follows:

• Federal Inventory Update
• Public Comments
• Working Group Feedback on Draft Chapters
• Designation of Writers for Unassigned Chapters
• Review of Report Graphics

Holiday Goodreau, Executive Director, LivLyme Foundation; Co-creator, TickTracker; Working Group Co-Chair, presented the objectives for Meeting 23, which included votes on the order of chapters, recommendations, and the implementation plan; a discussion of chapter comments and revisions; and a review of the timeline for the report preparation process. Linden presented the Day 1 for Meeting 23, which was as follows:

• Public Comments
• Vector Borne Disease National Strategy Update
• Vote on Order of Chapters
• Final Review of Chapter Comments, Chapter Votes, and Progress Updates
  • Tick Ecology (Final Review of Comments and Vote)
  • Clinical Presentation and Pathogenesis (Final Review of Comments and Vote)
  • Public Comment Chapter (Progress Update)
  • Executive Summary, Introduction, and Conclusion Chapters (Progress Update)

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.

Public Comments

Holiday welcomed public commenters and reminded the public of the three ways to engage with the Working Group: (a) providing oral public comments at public meetings, (b) submitting written public comments for a public meeting by email to tickbornedisease@hhs.gov, and (c) sending comments any time by email to tickbornedisease@hhs.gov. Holiday stated that the last day for the public to submit written comments for inclusion in the Report to Congress is Tuesday, October 11th.

Karen Duffy: Karen is a Lyme disease patient advocate. She said she’s been dealing with Lyme disease symptoms since she was a youth working with horses. Karen has periods of remission but states she’s now in a constant state of illness, which has cost her livelihood, career, and family. After being misdiagnosed for numerous other illnesses, she discovered positive Lyme disease tests she had received that were missed by other clinicians. Karen now dedicates her life to advocacy in order to improve conditions for the next generation. She reported that, in addition to constant pain, she has other symptoms including gastrointestinal distress and neuropathy. She implored the Working Group to listen to patients.

Gus Thalasinos: Gus is a 32-year-old Lyme disease patient and advocate from Long Island, NY. He reported minor symptoms throughout his youth—but in his first job after graduating college, he developed chronic fatigue. Gus stated he has been bed-bound for nearly a decade. He reported more than 30 symptoms across his bodily systems, including encephalitis. Gus said he was gaslit by providers and made to believe his symptoms were psychiatric. Eventually he was referred to a Lyme disease specialist and had to pay significant funds to get treatment. Gus noted that hundreds of peer-reviewed studies detail persistent Lyme disease, which claims the lives of patients due to infection and suicide—and many patients fight for years for benefits to cover their treatments. Gus remarked that he is privileged enough to be able to afford treatment, but many struggling patients cannot, which underscores the need for major change.

Dawn Whiting: Dawn reported symptoms from multiple tick-borne diseases since 2009. Dawn noted that research for COVID-19 receives significantly more funding and attention than tick-borne diseases. She felt that CDC was not taking undiagnosed tick-borne disease seriously, which she said leads to chronic illness. Dawn observed that misdiagnoses are common—and patients lack insurance coverage for treatment even if they are diagnosed correctly. She noted that she has to travel significant distances for care. She also stated that providers either disbelieve patients or face obstacles in treating patients due to lack of liability insurance and professional stigma. Dawn advocated for better diagnostics, clinician education, increased funding for research, and improved insurance reimbursement models for treatment of tick-borne disease.

Paula Doucette: Paula stated she was a registered nurse for more than 20 years. She explained that she was bedridden with tick-borne disease until she received a homeopathic treatment that alleviated her symptoms. Paula believed that widespread corruption prevented these types of treatments from being more widely available. She advocated for homeopathic treatments and stated her belief that vaccines caused the resurgence of her tick-borne disease.

Karen Vanderhoof-Forschner: Karen began by commenting on the 2018 Working Group subcommittee proceedings. She then explained that the Lyme Disease Foundation has CDC-approved K-12 educational materials, which she can send to members of the public. Karen stated the content has been published on PBS and other stations and provides information on tick-borne diseases and patient advocacy.

Andrea Jackson: Andrea stated that the Working Group’s non-federal members should not cooperate with the members representing federal agencies. She expressed concern about dissemination of false information related to tick-borne disease research and planning, and she claimed that unscrupulous entities were profiting from undiagnosed and misdiagnosed Lyme disease patients. She advocated that non-federal members reject the work they completed on the Working Group Report to Congress and release a minority report instead.

Rebecca Welsh: Rebecca asserted the existence of chronic Lyme disease and advocated for it to be designated as a disabling illness. She noted that diagnostics for tick-borne disease are faulty and hamper surveillance efforts. Rebecca requested that CDC update its guidelines, so providers have access to more comprehensive information, which will prevent harm to patients. Rebecca commented that new diagnostics capture chronic Lyme disease accurately, and more effective treatments exist in Europe; however, she claimed that these are not acknowledged by the federal government.

Vector-Borne Disease National Strategy Update

Kristen Honey, PhD, PMP Executive Director of InnovationX, HHS, provided an update on the National Strategy for Vector-Borne Disease, which she co-leads with Sue Visser, PhD, Associate Director for Policy and Extramural Program, Division of Vector-Borne Diseases, CDC. Kristen noted that the National Strategy effort is comprised of 17 participating federal agencies and divisions, led by OASH and CDC. The goal of the National Strategy is to coordinate work on vector-borne diseases in an integrated “whole-of-government” approach. This goal encompasses:

• Identifying and assessing gaps and unnecessary duplication of work
• Identifying strategic goals to address vector-borne disease
• Identifying benchmarks to measure progress toward achieving such goals

The National Strategy was established by the 2019 Kay Hagan Tick Act. The Act not only called for the formation of a national strategy, but it also authorized $20M per year for CDC to issue grants to public health departments and $10M to continue CDC’s Regional Centers of Excellence to study vector-borne diseases. Kristen noted that the funds still need to be appropriated by Congress.

Sue underscored the urgency of addressing tick-borne diseases and associated illnesses as part of the National Strategy effort. CDC observed that diagnoses of tick-borne diseases had doubled over the past 15 years and identified at least seven new tick-borne pathogens. The Tick Act mandates that the administrators of the National Strategy base their activities on the Working Group’s recommendations and the National Public Health Strategy. The National Strategy is also required to consult with diverse individuals and organizations, including patient advocates and others across multiple disciplines and sectors focused on vector-borne diseases. Sue noted that the National Strategy will be published at the end of 2023 and will release biannual updates thereafter.

Vector-Borne Disease National Strategy Framework

Sue explained that the National Strategy is based on the National Public Health Framework, which focuses on domestic activities by the federal government to detect, prevent, and control vector-borne diseases in human beings. She noted that, although critical to public wellness, the following issues are outside the scope of this prevention and control strategy, per congressional direction: clinical and healthcare service provision, access to care, and reimbursement/payment for clinical services. Sue noted that the 15 participating agencies are not responsible for delivering care but will be developing public health strategies. Other federal offices with the mission to advance clinical care and healthcare services for vector-borne diseases could, in parallel, develop a complementary vector-borne disease services strategy—and Sue welcomed federal partners to engage in this collaborative work.  

Vector-Borne Disease National Strategy Vision, Mission, and Goals

Kristen explained that Vector-Borne Disease National Strategy group began its work in 2019, with CDC and HHS seeking public input. The group consistently attended Tick-Borne Disease Working Group meetings. By 2022, HHS put out a Request for Information (RFI) to seek additional input from stakeholders—and plans to release a second RFI in November 2022. The group also established a mission and vision during this time. The vision of the Vector-Borne Disease National Strategy is “a nation where vector-borne diseases no longer threaten human health and well-being.” Their mission: Protect people from illness, suffering, and death due to vector-borne disease. As a result of feedback from the first RFI, the National Strategy group drafted a list of five goals consisting of 19 strategic priorities, 43 objectives, and 119 subobjectives. The five goals are as follows:

• Better understand when, where, and how people are exposed to and get sick or die from vector-borne diseases
• Develop, evaluate, and improve tools and guidance for the diagnosis and detection of vector-borne diseases
• Develop, evaluate, and improve tools and guidance for the prevention and control of vector-borne diseases
• Develop and assess drugs and treatment strategies for vector-borne diseases
• Disseminate and support the implementation of effective public health and vector control products, tools, and programs to prevent, detect, diagnose, and respond to vector-borne disease threats

Kristin reiterated that the National Strategy group will be seeking feedback for its upcoming RFI. Opportunities for feedback include public meetings, webinars, open innovation events, ad hoc meetings, technical reviews, open “office hours,” and workshops. She emphasized the group’s commitment to patient-led communities and hoped that these stakeholders would actively engage in submitting feedback. She noted the importance of building bridges between advocates and government.

Discussion

Jennifer Platt, DrPH, Co-founder, Tick-borne Conditions, inquired how the National Strategy group will communicate its work to local health departments and agencies. She noted that in her state of North Carolina, these agencies are not always familiar with work happening at the federal level. Sue responded that CDC is engaging directly with local jurisdictions through funded projects involving infectious diseases. She also noted that there is a vector-borne disease program in every state that local health agencies can contact. Elizabeth (Betty) Maloney, MD, President, Partnership for Tick-borne Diseases Education, asked how the National Strategy group will help develop better guidance for diagnostics and treatments for tick-borne diseases. Sue responded that the group is committed to updating and revising the guidance—but this work has not yet commenced. Jennifer proposed creating a comprehensive table of all the Tick-Borne Disease Group recommendations to provide clear guidance to the National Strategy group. Sue expressed enthusiasm for the proposal and stated that CDC is committed to incorporating the Working Group’s recommendations into their ongoing activities.

Vote on Order of Chapters

Linden informed the Working Group that a vote was scheduled to establish the order for the chapters in the upcoming report to Congress. He presented the current order of the chapters:

1. Executive Summary
2. Introduction
3. Methods
4. Public Comments
5. Access to Care and Education
6. Changing Dynamics of Tick Ecology, Personal Protection, and Control
7. Clinical Presentation and Pathogenesis
8. Diagnostics
9. Disease Prevention and Treatment
10. Looking to the Future
11. Conclusion
12. Appendices

Before voting, Working Group members discussed the order of the chapters. Jennifer recommended that the Methods chapter be converted into an appendix in order to improve the readability of the report. Charles Benjamin (Ben) Beard, PhD, Deputy Director, Division of Vector-borne Diseases, Centers for Disease Control and Prevention, agreed and suggested that the Public Comment chapter be moved to the beginning of the report. Members briefly discussed the location of the Access to Care and Education chapter and agreed that it should follow the Public Comments chapter.

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, proposed moving the Changing Dynamics of Tick Ecology, Personal Protection, and Control chapter toward the end of the document after the Disease Prevention and Treatment chapter. Kirby C. Stafford III, PhD, Chief Scientist and State Entomologist, Department of Entomology, Center for Vector Biology & Zoonotic Diseases, The Connecticut Agricultural Experiment Station, disagreed with Todd’s proposal—noting that ticks are the central topic of the report and should be introduced earlier.

Votes

Linden proposed a motion to move the Methods Chapter to the appendix. Fourteen members voted yes, and the motion passed unanimously.

Todd proposed a motion moving the Tick Ecology after the Disease Prevention and Treatment Chapter. Nine members voted no, four voted yes, and one abstained. The motion failed.

Changing Dynamics of Tick Ecology, Personal Protection, and Control 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 on screen the chapter manuscripts and member comments and to record Working Group content decisions. Holiday also noted that comments involving minor changes to wording do not need to be formally addressed during the meeting—and would be fixed during the final editorial process.

Comment 1 from Linden Hu

In his comment, Linden noted that the text in Rationale 3.2 could be edited for clarity. Kirby agreed. Linden proposed editing the section during the meeting, but Kirby opted to take more time for editing.

Comment 2 from Betty Maloney

Betty noted that the statistics provided in the chapter text were different from those in the chart placed directly below the text. Kirby responded that the in-text figures were derived from a citation while the chart figures are collated. Kirby opted to change the in-text section to a broad statement to avoid confusion. Jennifer also noted that the figures in the chart could be rounded for readability. Cat made a note for the graphic designer to address the figure revisions.

Comment 3 from Betty Maloney

In her comment, Betty expressed that the meaning of a particular passage was unclear. Gabriella (Gaby) Zollner (Romero), PhD, Program Manager, Deployed Warfighter Protection Program, U.S. Department of Defense, suggested an edit for clarity. Cat made the suggested edit. Monica E. Embers, PhD, Associate Professor and Director of Vector-borne Disease Research, Tulane National Primate Research Center, agreed that the rewording helped. Kirby agreed.

Comment 4 from Betty Maloney

Betty suggested an edit for another passage. Kirby agreed with the change. Cat instituted the edit during the meeting.

Comment 5 from Betty Maloney

In her comment, Betty observed that the layout around a text box caused confusion. Cat explained that the layout has not been finalized and would be revised.

Comment 6 from Betty Maloney

Betty suggested a minor change in wording in a selected passage. Kirby agreed with the change.

Comment 7 from Linden Hu

In his comment, Linden suggested adding a sentence between two ideas expressed in a passage to link them. Kirby agreed and suggested moving the sentence toward the end of the paragraph to increase clarity and readability. With Gaby and Betty’s input, Cat made the edit.  

Comment 8 from Betty Maloney

Betty suggested rewriting a passage as a numbered list. Kirby had no objections. Cat created a numbered list during at the meeting.

Comment 9 from Betty Maloney

Betty suggested that a sentence be deleted because it was expressed earlier. Kirby agreed, and Cat deleted the sentence.

Comment 10 from Betty Maloney

Betty noted that a sentence was redundant and could be deleted. Kirby agreed. Gaby suggested an editorial change in order to improve the clarity of this final sentence in the paragraph. Cat edited the passage.

Comment 11 from Betty Maloney

Betty suggested an editorial change, but noted that the change did not need to be implemented. Kirby intimated that several specific points would need to be added to address the comment. Betty withdrew her suggestion.

General Comment by Holiday Goodreau

Holiday reiterated that minor editorial changes and copyedits would be made by Rose Li & Associates following final votes to approve the chapters. Holiday observed that the Working Group could vote on approving the chapter, provided that the changes Kirby makes would be along the lines of those discussed by the Working Group. Kirby agreed.

Vote

Linden made a motion to approve the Changing Dynamics of Tick Ecology, Personal Protection, and Control chapter, including edits made during the meeting and those that will be made by Kirby directly after the meeting. Ben observed that another final vote to accept the entire report will be made during the Working Group’s final meeting, as well—which Jim confirmed. Linden’s motion received 14 yes votes, and the motion was unanimously approved.

Clinical Presentation and Pathogenesis Chapter Review

Linden noted that some comments in the chapter had already been resolved since the previous meeting. The Working Group disregarded those and focused on comments that had not yet been addressed. The Working Group members agreed that unresolved nomenclature issues would be resolved during copyediting using the rules established at Meeting 22.

Comment 1 from Ben Beard

In his comment, Ben noted that Recommendations 4.4 and 4.5 should be adjusted to reflect the voted-upon nomenclature. Cat made the change. Betty questioned the use of the term “tick bite-associated chronic illness.” Jennifer clarified that the term was used in part to recognize Alpha-gal Syndrome (AGS), which is not classified as a disease. Betty proposed simplifying the term to “tick-associated chronic illness.” Cat noted that not all the nomenclature discussed was voted on. Ben and other members agreed to this use of terminology.

Comment 2 from Betty Maloney

In her comment, Betty recommended redesigning a table for readability. Cat noted that the table would be updated by a graphic designer for consistency with other graphics in the report.

Comments 3-6 from Betty Maloney

Members identified these comments as minor editorial changes that did not need to be addressed by the group.

Comment 7 from Betty Maloney

Betty expressed confusion about a descriptor and Ben responded that it was meant to convey frustration patients experience when they lack access to care. Ben proposed taking out the term for clarity. Jennifer recalled writing the section and corrected the term.

Comment 8 from Betty Maloney

Betty noted that the chapter lacked a conclusion. Ben agreed that a succinct end to the chapter would be preferable. Linden thought the addition of a brief conclusion would be appropriate for all chapters but would not necessitate an additional vote as long as it did not introduce new information. The group also considered introducing the next chapter in these conclusions, but decided against the idea.

Vote

Betty made a motion for the Working Group to accept the Presentation and Pathogenesis Chapter, as written. Betty’s motion received 14 yes votes and the motion was unanimously approved.

Public Comment Chapter Update

Holiday began the progress update for the Public Comment chapter by reiterating that the public comment period for inclusion in the Report to Congress closes October 11th, 2022. She added that the Working Group has received an increased volume of public comments since the last meeting.

Lauren Overman, MPH, CPH, Public Health Analyst, Office of Infectious Disease and HIV/AIDS Policy, HHS, provided details about the analysis presented in the chapter. She noted that the analysis of public comments not only encompasses the period of the most recent iteration of the Working Group, but all six years of public comments since the Working Group was first inaugurated.

In total, the Working Group received 1,400 emails, 517 written comments submitted for public meetings, and 220 verbal comments. The Public Comment Subcommittee produced a qualitative analysis of these comments using NVivo software. The data was then visualized using Tableau and Microsoft Excel. This allowed for the identification and encoding of comment themes.

Lauren outlined the following limitations of the analysis: encoding primarily by a single researcher; redactions limiting some data from inclusion; difficulty identifying the number of unique messages; and the differing lengths of time of the three Working Group reporting cycles. When divided by disease or condition, the majority of comments were about Borrelia burgdorferi. The second most frequently mentioned topic was tick-borne disease, in general, followed by Alpha-gal Syndrome, and then other tick-borne diseases. Chapter authors assembled a word cloud featuring frequently mentioned topics.

Topics introduced by public commenters were divided into categories: challenges, epidemiology, ethics, federal advisory committee business, morbidities, patient experience, and resources. These categories were then further divided into nodes—or prominent themes within each category. Comments were also subdivided geographically, which will be displayed in the report as a graphic.

Executive Summary, Introduction, and Conclusion Chapter Updates

Linden provided a brief update on the Executive Summary, Introduction, and Conclusion chapters. He noted that these sections are in progress but had nothing to report during the meeting. Linden explained that the Working Group should expect drafts of this content within 7-10 days. This content will be discussed at the next meeting at the end of October.

Diagnostics Chapter Review

Holiday opened the discussion of the Diagnostics chapter, which was added to the Day 1 meeting agenda to allow additional time for Day 2 agenda items. Monica noted that there were few comments, and most were regarding minor editorial changes.

Comment 1 from Linden Hu

Linden noted that his comment was a minor editorial comment that did not need to be scrutinized by the group.

Comment 2 from Betty Maloney

Betty added a slight grammatical edit, which Cat corrected during the meeting.

Comment 3 from Betty Maloney

Betty’s comment involved using the term Ixodes spp. (several species) to describe the black-legged tick. Kirby and Jennifer observed that Ixodes incorporates far more tick species than just the black-legged tick. Ben noted that CDC follows the globally accepted terminology (black-legged tick) when talking about Ixodes. Monica recommended just using black-legged tick, rather than extrapolating the statement to including all Ixodes species. Members agreed with this change and Cat made the edit.

Comment 4 from Betty Maloney

This was a minor editorial comment. The Working Group acknowledged it and moved on.

Comment 5 from Betty Maloney

Betty recommended inserting a citation for the passage in question. Monica agreed.

Comment 6 from Betty Maloney

Betty identified language carried over from the original Diagnostics Subcommittee Report to be updated. Monica agreed, and she and Betty proposed suggested edits. Cat made the change to the passage.

Comment 7 from Betty Maloney

Betty suggested a minor edit. Cat made the change live.

Comment 8 from Betty Maloney

Betty expressed in her comment that the content was unclear. Monica suggested splitting the suggested passage into two sentences. Cat instituted the change.

Comment 9 from Betty Maloney

Betty commented that the language of a selected passage could be clearer. Monica suggested a change and Cat edited the passage.

Vote

Betty made a motion for the Working Group to accept the Diagnostics Chapter, as written. Betty’s motion received 13 yes votes and one abstention. The motion was approved.

Discussion of Unresolved Issues

Linden opened a discussion on unresolved issues that had emerged from Day 1 of Meeting 23. Jennifer inquired about the status of the Federal Inventory since the last status update at the July meeting. Meghan Walsh, PhD, Senior Associate, Center for Scientific Research, Rose Li & Associates, Inc., confirmed that the report was completed and had been submitted to OIDP the week prior to this meeting—a full presentation on the Inventory would be provided to the Working Group at Meeting 24. Betty inquired how the Inventory would be incorporated into the report; Meghan responded that the Inventory is a standalone report—however, the Working Group agreed with Jennifer’s proposal to reference it in the Conclusion chapter of their report.

Holiday asked what the process should be for writing groups to add conclusions to their individual chapters. Linden noted that a final vote on the report is scheduled at the last Working Group meeting; as long as there was nothing new or controversial members planned to add, he did not anticipate any issues with completing the process in this fashion over the next few weeks. Kirby asked if there would be an opportunity for the Working Group to read these conclusion passages before the next meeting scheduled at the end of October—he noted that the late-October meeting would be an opportunity to raise any issues. Meghan noted that any reviews between this meeting and the next are up to the consensus of the Working Group.

Jennifer proposed identifying the top five recommendations of the 18 named in the Working Group report. Linden observed that each recommendation is valued by the subcommittee co-chairs who wrote them; picking the top five is likely an untenable proposal. Holiday stated that a discussion over favored recommendations would present too much potential for conflict. Kirby also lamented the recommendations that would be lost if this approach were taken. Jennifer noted that there were common themes among the recommendations, such as the need to create a biorepository, which could be identified. Linden observed that an earlier draft of the executive summary identified these themes; Betty commented that this approach of identifying themes in the executive summary was essential; however, the framing of the content needed rewriting. Jennifer offered to help write the executive summary to identify these themes.

CAPT Rebecca Bunnell, MPAS, PA-C, Senior Advisor, Division of Model Learning Systems, Learning and Diffusion Group, The Center for Medicare and Medicaid Innovation, Centers for Medicare and Medicaid Services, inquired about where diagnostics and treatment fit in the Vector-Borne Disease National Strategy. Sue responded that there are two facets to developing a diagnostic and treatment strategy. First, the LymeX diagnostic challenge prize will award $25M to an organization to innovate in this area. Applications are currently under review. Second, CDC is advertising and funding research contracts to identify new diagnostic strategies. Regarding treatment, Sue asked if the NIH representatives could provide an update—as this topic is within their purview. Dennis Dixon, PhD, Chief, Bacteriology and Mycology Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, HHS, stated that he was not prepared to identify which studies were allowed to be discussed publicly, but noted that these endeavors were too numerous to mention. Samuel S. Perdue, PhD, Chief, Basic Sciences, Bacteriology and Mycology Branch at National Institutes of Health agreed with Dennis insofar as this was an active field with many ongoing projects related to treatment. Sam identified a study involving oral doxycycline for meningitis in children as an example. Holiday inquired when these studies would be released publicly; Sam responded that these would be released after 2024. Ben pointed out that the National Strategy group will present objectives and subobjectives for public comment on November 1st, 2022. Ben underscored that these objectives and subobjectives were written in consideration of the Working Group’s recommendations, which should be evident when they are released.

Betty asked Sue how current investigations into diagnostics and treatment affect new guidelines being developed by the National Strategy group. Sue responded that these processes are happening in parallel—citing new guidance on Rocky Mountain spotted fever and plague as examples. Betty followed up by asking if public stakeholders are included in developing such guidance—Sue responded affirmatively, noting that the National Strategy group relies on professional societies where guidance exists and on advocacy groups where it does not. Betty expressed concern about the level of transparency of guideline development; she noted that when Gordon Guyatt, MD, presented his work to her subcommittee, he stressed there must be transparency in communication about the strength of evidence (and the level of uncertainty) backing up underlying assumptions.

Holiday inquired if the Vector-Borne Disease National Strategy will be separated by vectors. Sue noted that the report is disease agnostic and meant as a strategy that can be used across all vector-borne diseases, prioritized by disease impact. She identified four diseases prioritized by CDC: Lyme disease, dengue viruses, West Nile virus, and Rocky Mountain spotted fever. Sue also noted that CDC receives guidance from Congress every year on how to spend funding specifically earmarked for addressing vector-borne diseases. This guidance, Sue observed, helps CDC focus its activities. Ben reiterated that the National Strategy is meant to be disease agnostic; nevertheless, he underscored that tick-borne diseases constitute the vast majority of vector-borne diseases, and he would ensure they are not neglected as the National Strategy group moves forward with their work.

Adjournment

Linden thanked the Working Group members for their continued diligence in revising their chapters. Jim adjourned the meeting at 2:15 pm EST.

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 (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

Andrew Y. Li, PhD, Research Entomologist, Invasive Insect Biocontrol & Behavior Laboratory, U.S. Department of Agriculture

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

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 Director, 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