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                              April 27-28, 2022, TBDWG Meeting (online)
                              TBDWG April 27 - 28, 2022 - Meeting Summary - Day 2


    

    

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TBDWG April 27 - 28, 2022 - Meeting Summary - Day 2








  
  
    

  
      





April 28, 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 2

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,welcomed participants and called the meeting to order. Jim conducted roll call (see Appendix 1 and Appendix 2: Tick-Borne Disease Working Group Members and HHS Support Staff). The meeting began with a quorum.

Working Group 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:

No later than two years after the date of enactment of the authorizing legislation, review a summary of:
	Ongoing tick-borne disease research, including research related to causes, prevention, treatment, surveillance, diagnosis, diagnostics, duration of illness, and intervention;
		Advances made pursuant to such research;
		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;
		Gaps in tick-borne disease research described in clause 3b;
		The Working Group’s meetings; and
		The comments received by the Working Group.
	Make recommendations to the Secretary regarding any appropriate changes or improvements to such activities and research.
	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.Recap of Day 1 and Day 2 Agenda

Linden Hu, MD, Tufts University School of Medicine, Professor Microbiology and Medicine; Vice Dean for Research; Working Group Co-Chair, greeted attendees and summarized the proceedings from the previous day’s meeting. These included public comments, a LymeX update, a vote to accept submission of all five subcommittee reports, discussion, and vote on proposed recommendations by three subcommittees (Diagnostics; Tick Ecology, Personal Protection, and Control; and Disease Prevention and Treatment), and an update on the Federal Inventory.

Holiday Goodreau, Executive Director, LivLyme Foundation; Co-creator, TickTracker; Working Group Co-Chair, explained that the Day 2 meeting would feature the following agenda items:

Discussion and Vote on Recommendations Proposed by the Following Subcommittee Co-Chairs:
	Access to Care and Education
		Clinical Presentation and Pathogenesis
	Review of the Report to Congress Outline to Ensure It Represents the Approved Recommendations
	Division of Report Writing
	Review of Meeting #21, Including Approved Recommendations
	Next StepsReview of Proposed Recommendations

On Day 2, two of five subcommittees presented their proposed recommendations and rationale for consideration by the full Working Group. After each presentation, Working Group members discussed the language of the proposed recommendations, agreed on alterations where applicable, and voted on their inclusion in the 2022 Report to Congress.

Proposed Recommendations from the Access to Care and Education Subcommittee

Subcommittee co-chair Elizabeth (Betty) Maloney, MD, President, Partnership for Tick-borne Diseases Education, introduced herself and the other members of the Access to Care and Education Subcommittee. She presented five proposed recommendations for the Working Group to consider. She explained that for Proposed Recommendation 1, she would first present the original language that the Subcommittee voted to approve two months prior. However, during the whiteboard exercise with the full Working Group, she would present new language for Proposed Recommendation 1. The language and discussions are as follows.

*Proposed Recommendation 1 (Original language approved by the Subcommittee): Fund and support a directive for the CDC [Centers for Disease Control and Prevention] to conduct a review of CDC webpages and the current CDC TRAIN educational modules pertaining to the prevention, diagnosis, and treatment of Lyme disease to determine whether they best reflect the current state of the science and appropriately delineate areas of scientific uncertainty.*

*This review will be conducted by a newly formed committee under the aegis of HHS. This committee will include meaningful stakeholder engagement of subject matter experts, which could be established under the Federal Advisory Committee Act (FACA).*

*The committee members will include:*

*Patients, caregivers, or patient advocates who can meaningfully represent Persistent Lyme Disease (PLD)/Chronic Lyme Disease (CLD) community interests,*
	*Clinicians (including clinicians who treat PLD/CLD and clinicians who are subject matter experts in PLD/CLD education), and*
	*Research scientists with expertise/ experience that represents diverse scientific perspectives on the full spectrum of Lyme disease**Stakeholders will be active members of the committee, involved with selecting priority areas for review, determining important outcomes that matter to patients, conducting the review, and assisting with dissemination of results.*

*The aim of the review is to work in collaborative fashion to identify the scientific unknowns of Lyme disease.*

*As part of its work, the committee will engage in a “Red Team” exercise to determine the strengths and weaknesses of the current CDC TRAIN CME modules and webpage content. A Red Team is defined as a team that is formed with the objective of subjecting and organization’s plans, programs, ideas, and assumptions to rigorous analysis and challenge.*

Betty explained that the rationale for this finding is to provide clinicians with scientifically accurate and clinically relevant information that is sufficiently detailed for clinical decision-making. Patients do best when diagnosed and treated early in the disease process, and well-informed clinicians are critical to improving outcomes for patients.

Betty also emphasized that CDC is an important vehicle for disseminating information about tick-borne diseases. A rigorous review of CDC educational content should involve input from a variety of knowledgeable stakeholders and ensure that clinician education reflects the primary literature as well as the nuances and uncertainties of tick-borne diseases.

*Proposed Recommendation 2: Fund and support modification of the Federal government websites, starting with CDC and NIH [National Institutes of Health] websites, as well as educational materials and seminars for clinicians, the public, and public health departments to incorporate the following language: “The state of the science relating to persistent symptoms associated with Lyme disease, is limited, emerging, and unsettled; and increase public awareness that there are divergent views on diagnosis and treatment. Consider that shared medical decision-making may be appropriate in some circumstances.”*

Betty noted that Recommendation 2 is similar to Recommendation 7.1 in the 2020 Tick-Borne Disease Working Group Report to Congress. Furthermore, CDC has since updated the language on the “Treatment of Lyme Disease” landing page in keeping with Recommendation 2.

*Proposed Recommendation 3: Provide the HHS Secretary with discretionary authority to maintain telehealth flexibilities independent of Public Health Emergency declaration (e.g., coverage of services in the patient's home and in any geographic area as an “originating site,” payment parity for in-person vs. telehealth services).*

*Additionally, include PLD/ CLD patients as a unique group requiring specialized integrated care delivery similar to Long COVID and Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome communities.*

*Interdisciplinary care needs may require expanding eligible practitioners who can furnish telehealth in Medicare (e.g., physical therapists, occupational therapists) outside of the already covered telehealth services for the mental health, behavioral health, and neurocognitive dimensions of PLD/ CLD.*

*Proposed Recommendation 4: In alignment with NIH Strategic Plan for Tickborne Disease Research, fund, support, and encourage community-based participatory research for PLD/ CLD and complex presentations of late Lyme disease.*

*Develop and grow community research capacity to accelerate the fundamental knowledge base using “big data” registries, data-sharing platforms, specimen and tissue sample repositories, and genomic and precision medicine approaches that reflect the underlying heterogeneous nature of persistent/chronic Lyme disease*
	*Leverage existing NIH resources and expand collaborations across NIH to promote a multidisciplinary approach to tick-borne disease research with, for example, the NIH Community-Based Participatory Research Program (CBPR)**Proposed Recommendation 5: In alignment with NIH Strategic Plan for Tickborne Disease Research, utilize tick-borne diseases as a use case in the catalyzation of innovative change across Federal agencies to accelerate the pace of break-throughs to transform medicine and health such as creating capabilities to include agnostic platforms that could be applied across many diseases (e.g., ARPA-H, or projects researching long tail diseases such as COVID, Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome, and Lyme disease).*

**Discussion of Access to Care and Education Subcommittee Proposed Recommendations**

Subcommittee co-chair CAPT Rebecca Bunnell, MPAS, PA-C, Senior Advisor, Learning and Diffusion Group, Center for Medicare & Medicaid Innovation, Centers for Medicare & Medicaid Services (CMS), opened discussion of the Access to Care and Education Subcommittee recommendations. She explained that after consultation with CDC representatives, she and Betty revised the language of Proposed Recommendation 1 to reflect their suggestions. Rebecca had the new language (below) presented on the whiteboard for Working Group members to review and discuss.

*Proposed Recommendation 1 [New language for Working Group consideration – to replace the original language presented earlier]: Request that Congress authorize a new FACA to continue the work of the TBDWG [Tick-Borne Disease Working Group] as we as review and make recommendations about federal websites and training that include tick-borne disease content including Lyme disease. The purpose of the review is to determine whether they best reflect the current state of the science and appropriately delineate areas of scientific uncertainty. The committee members will include (a) patients, caregivers, or patient advocates who can meaningfully represent the acute and persistent Lyme disease (PLD)/chronic Lyme disease (CLD) perspectives, (b) clinicians (including clinicians who treat patients with acute and PLD/CLD as well as clinicians who are subject matter experts in acute and PLD/CLD education), and (c) research scientists with expertise/experience that represents diverse scientific perspectives on the full spectrum of Lyme disease. Stakeholders will be active members of the committee, involved with selecting priority areas for review, determining important outcomes that matter to patients, conducting the review, and assisting with dissemination of results. The aim of the review is to work in a collaborative fashion to identify the scientific knowns and unknowns of Lyme disease.*

*Rewording of Recommendation 1*

Linden reminded Working Group members that the consensus from Day 1 was to include any FACA recommendations in a separate section of the Report to Congress before the recommendations presented in the main chapters. Members agreed that there should be a FACA section near the beginning of the report. Linden asked Rebecca to clarify whether an additional FACA would be necessary if the Tick-Borne Disease Working Group were renewed. Charles Benjamin (Ben) Beard, PhD, Deputy Director, Division of Vector-borne Diseases, Centers for Disease Control and Prevention, cautioned against recommending an additional FACA, favoring instead a renewal of the existing Tick-Borne Disease Working Group, so that it could include the goals of the Access to Care and Education subcommittee findings. Jennifer Platt, DrPH, Co-founder, Tick-borne Conditions, suggested that the language be modified such that the committee include stakeholders representative of all tick-borne diseases and conditions, not just Lyme disease, in keeping with wording of the initial portion of the finding. Sunil requested clarification on the distinction between PLD and CLD, to which Betty responded that the two terms were functionally equivalent, butm that CLD is more commonly used by the public and PLD is preferred in scientific research. Linden suggested that the two terms be defined early in the report to minimize confusion.

Betty clarified that the objective of the first recommendation is to establish a review of the evidence used to make educational materials. As science is constantly changing, a review would ensure that the information in educational materials and resources would be up-to-date and accurate. Ben proposed that instead of recommending that a new FACA be created, the same goal could be accomplished by submitting an Information Quality Request to CDC and/or other government website(s). Betty added that she had already submitted such quality review requests, but that her goal is to perform a more unified, official review of the current material appearing on federal government and CDC websites, inclusive of any institution providing educational materials on tick-borne diseases.

Linden emphasized that any recommendation or plan of action must be feasible. Instead of recommending the creation of a new FACA, he asked Ben to guide changes to the language that could accomplish the same goal. Jim clarified that the Report to Congress would contain recommendations, and that Congress would be able to determine the necessary steps to act on the recommendations. Linden suggested including the language from Recommendation 1 in the FACA renewal request.

Monica E. Embers, PhD, Associate Professor and Director of Vector-borne Disease Research, Tulane National Primate Research Center, asked Betty whether the same criteria that were used to select members of the Tick-Borne Disease Working Group would also be used to select members of the committee requested in the recommendation. She also asked for more information about the “Red Team” approach. Betty responded that the “Red Team” approach would not be necessary if there were subject matter experts as external reviewers of the webpages and educational materials.

Betty and Rebecca agreed with Linden’s suggestion that Recommendation 1 be tentatively removed and instead incorporated into a separate section outlining requests and recommendations for the creation of a new FACA. To streamline the language and highlight priorities, the Working Group recommended a revision of the recommendation as follows:

Recommendation 0 (formerly 1): *Request that Congress authorize a new Federal Advisory Committee Act (FACA) to continue the work of the TBDWG as well as review and make recommendations about federal websites and training that include Tick Borne Disease content including Lyme disease. The purpose of the review is to determine whether they best reflect the current state of the science and appropriately delineate areas of scientific uncertainty. The committee members will include (a) patients, caregivers, or patient advocates who can meaningfully represent the acute and persistent Lyme disease (PLD)/chronic Lyme disease (CLD) perspectives and other vector-borne conditions, (b) clinicians (including clinicians who treat patients with acute and PLD/CLD as well as clinicians who are subject matter experts in acute and PLD/CLD education), and (c) research scientists with expertise/experience that represents diverse scientific perspectives on the full spectrum of Lyme disease. Stakeholders will be active members of the committee, involved with selecting priority areas for review, determining important outcomes that matter to patients, conducting the review, and assisting with dissemination of results. The aim of the review is to work in a collaborative fashion to identify the scientific knowns and unknowns of Lyme disease.*

The rationale remained unchanged.

*Rewording of Recommendation 1 (formerly 2)*
Betty suggested that the language in this recommendation reflect the updated language on the CDC webpage. Linden cautioned against submitting requests for actions that have already been taken, as is the case of CDC updating their language. Betty emphasized that CDC is not the only target of the recommendation, and that the recommendation should remain. The goal of this recommendation is to have other websites (NIH for instance) and resources reflect the changes made by CDC.

Jennifer asked Betty to clarify whether this recommendation would be inclusive of other tick-borne diseases or exclusively Lyme disease. Betty clarified that this recommendation was specifically focused on Lyme disease. Monica suggested that the language reflect continued updating in the future as the science changes to incorporate new evidence and research findings. Kirby suggested the inclusion of “continued” to the first line of the recommendation to address Monica’s point.

Jennifer suggested eliminating the “following language” quote to reflect future changes to the science. Betty recommended instead to replace the quote with the language taken directly from the CDC website to highlight their recent update. Kirby harmonized Jennifer’s and Betty’s concerns to recycle the quote into the language of the recommendation.

In order to streamline the language and highlight priorities, the Working Group agreed to a revision of the recommendation as follows:*Rewording of Recommendation* 1 (formerly 2):*Fund and support continued and ongoing modification of the Federal government websites, starting with the CDC and NIH websites, as well as educational materials and seminars for clinicians, the public, and public health departments to reflect the current state of the science related to persistent symptoms associated with Lyme disease given that there are divergent views on diagnosis and treatment.*

*Recommendation 2 (formerly 3)*
Betty suggested that the language of recommendation should reflect the updated language on the CDC webpage.

The Working Group recommended a revision of the recommendation as follows:

*Recommendation 2 (formerly 3): Provide the HHS Secretary with discretionary authority to maintain telehealth flexibilities independent of Public Health Emergency declaration for patients with tick-associated illnesses in order to maintain access parity and equity for those receiving in-person and telehealth services.*

The Working Group recommended that the latter portion of the recommendation (beginning with “For example”) be shifted to the rationale section of the recommendation.

*Rewording of Recommendation 3 (formerly 4)*
The Working Group recommended a revision of the recommendation as follows:

*Recommendation 3 (formerly 4): Fund, support, and encourage community-based participatory research for PLD/ CLD and complex presentations of late Lyme disease and other tick-borne diseases. This includes the development and growth of community research capacity to accelerate the fundamental knowledge base using “big data” registries, data-sharing platforms, specimen and tissue sample repositories, and genomic and precision medicine approaches that reflect the underlying heterogeneous nature of tick-borne diseases.*

*Rewording and Tabling of Recommendation 4 (formerly 5)*

Linden recommended that Recommendation 4 be rewritten to be more actionable. 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, emphasized that the intention of this recommendation is to support research into underlying mechanisms that may also be active in non-tickborne diseases. Holiday suggested that the request center around the inclusion of tick-borne diseases into the Advanced Research Projects Agency for Health (ARPA-H). Rebecca noted that the underlying idea of the recommendation was sound, but that the content might better fit in the FACA section of the Report to allow for more deliberation time due to time constraints.

Linden suggested that the recommendation be tabled for the time being and discussed or refined during the July meeting. The current language of the tabled recommendation is as follows:

*Recommendation 4 (formerly 5) - tabled**:**In alignment with NIH Strategic Plan for Tickborne Disease Research, utilize TBDs as a use case in the catalyzation of innovative change across Federal agencies to accelerate the pace of break-throughs to transform medicine and health such as creating capabilities to include agnostic platforms that could be applied across many diseases (e.g., ARPA-H, or projects researching long tail diseases such as COVID, Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome, and Lyme disease).*

***Vote on Access to Care and Education Subcommittee Priorities***

Vote on Recommendation 1: 13 in favor, 1 absent
	Vote on Recommendation 2: 13 in favor, 1 absent
	Vote on Recommendation 3: 13 in favor, 1 absentProposed Recommendations of the Clinical Presentation and Pathogenesis Subcommittee

Subcommittee co-chair Leith States introduced himself and the other members of the Clinical Presentation and Pathogenesis Subcommittee (see Appendix 2 for subcommittee membership). He presented five proposed recommendations for the Working Group to consider.

*Proposed Recommendation 1:****Support additional research on the mechanisms of pathogenesis of tick-borne disease, with a particular focus on central nervous system infection (including neuropsychiatric illness and neuropathic injury), persistent symptoms, allergy (Alpha-gal Syndrome), immunity, autoimmunity, pregnancy, and adverse fetal outcomes.*

Leith explained that the underlying basis for persistent symptoms related to tick bite-associated disease is often poorly understood. Defining the precise mechanisms of pathogenesis is critical to ensure safe and effective treatment options for persons who suffer from these illnesses.

Leith underscored the lack of existing research in each of the areas identified in Finding 1.2.

*Proposed Recommendation 2: Provide funding to support research investigating the prevalence of undetected tick-borne illness among subgroups of the population that may have a high burden of multi-systemic chronic conditions (e.g., mental illness, musculoskeletal diseases, etc.) that has been inadequately medically evaluated, including individuals in psychiatric facilities, prisons, homeless shelters, and other populations experiencing health disparities.*

Leith commented that the full spectrum of clinical presentation for various tick-borne diseases is often poorly understood, especially for some of the less common diseases and particularly in persons and communities that are medically underserved.

*Proposed Recommendation 3: Require labeling of foods, products, beverages (including alcohol), cosmetics, and pharmaceuticals that contain non-primate mammalian ingredients (active or inactive) and update the FDA’s Food Safety Modernization Act to incorporate Alpha-gal Syndrome (AGS) awareness training into the FDA’s “Retail Food Industry/ Regulatory Assistance and Training” Program.*

Leith explained that people who develop AGS may develop symptoms upon exposure to red meat and various mammalian products. Additionally, many AGS sufferers must worry about medications, products, and cross-contamination, which limits their daily lives. Adequate product labeling would make AGS sufferers aware of potential risk.

*Proposed Recommendation 4: Provide funding for prospective studies that evaluate clinical similarities; mechanisms of pathogenesis; and common etiologies for Post-COVID Conditions (PCC), other post-infectious fatiguing illness, post-treatment Lyme disease, and chronic symptoms attributed to Lyme disease and other tick-borne diseases.*

Leith clarified that many patients who have recently experienced SARS CoV-2 infection report persistent symptoms, often including fatigue, post-exertional malaise, and cognitive impairment, among others. Given the array of overlapping symptoms, studies regarding the clinical similarities and common etiologies for PCC and chronic symptoms associated with Lyme disease may provide insights into improved clinical management strategies.

*Proposed Recommendation 5: Develop and maintain comprehensive biospecimen repositories (e.g., whole blood, sera, cerebrospinal fluid, maternal and fetal tissues and fluids, and autopsy specimens) for use in developing and/or improving diagnostic assays, both direct and indirect, and for research into transmission and pathogenesis, for broad applications including early diagnosis, distinction of current versus past infection, and for use in pregnancy and fetal outcome applications.*

Leith highlighted that a comprehensive biospecimen repository will provide a huge resource for use both in the development of improved diagnostic tests but also for the understanding of underlying mechanisms of pathogenesis and disease process, which is critical to developing improved therapeutics.

**Discussion of Clinical Presentation and Pathogenesis Subcommittee Recommendations**

Leith opened discussion of the proposed recommendations for comments and questions. The Working Group utilized a whiteboard to edit priorities before voting on their inclusion in the Report to Congress.

Subcommittee co-chair Jennifer Platt explained that the subcommittee changed the wording of the findings for the report from their original presentation, though they were in essence very similar if not the same.

*Rewording of Recommendation 1*
The Working Group did not recommend any revisions of the recommendation from the original language:

*Recommendation 1: Support additional research on the mechanisms of pathogenesis of tick-borne disease, with a particular focus on central nervous system infection (including neuropsychiatric illness and neuropathic injury), persistent symptoms, allergy (Alpha-gal Syndrome), immunity, autoimmunity, pregnancy, and adverse fetal outcomes.*

*Rewording of Recommendation 2*
Monica asked for clarification on what kind of research (clinical and/or academic) would be specifically funded based on the recommendation. Ben responded that there was not a specific focus on funding clinical or academic research as this language would include epidemiological and other types of studies, but that the goal is to focus on underserved populations. Jennifer emphasized that research focused on and information about underserved populations is lacking.

The Working Group recommended a revision of the recommendation as follows:

*Recommendation 2: Provide funding to support research investigating the prevalence of tick-borne illness among subgroups of the population that may have a high burden of multi-systemic chronic conditions (e.g., mental illness, musculoskeletal diseases, etc.) that has been inadequately medically evaluated, including individuals in psychiatric facilities, prisons, homeless shelters, and other populations experiencing health disparities or disabilities.*

*Rewording of Recommendation 3*
Ben commented that this language came from the 2020 Report to Congress but that it has not yet been addressed. Jennifer added that an Act of Congress would be necessary to accomplish this goal. Betty and Holiday praised the subcommittee’s focus on AGS, specifically, due to the lack of initial attention it has received as a tick-borne illness.

The Working Group did not recommend any revisions of the recommendation from the original language:
Recommendation 3: *Require labeling of foods, products, beverages (including alcohol), cosmetics, and pharmaceuticals that contain non-primate mammalian ingredients (active or inactive) and update the FDA’s Food Safety Modernization Act to incorporate Alpha-gal Syndrome (AGS) awareness training into the FDA’s “Retail Food Industry/ Regulatory Assistance and Training” Program.*

*Rewording of Recommendation 4*
Ben cautioned against limiting the recommendation to funding prospective studies to the potential exclusion of retrospective studies. Leith agreed with Ben’s comment but added that most studies of long COVID are using a prospective design. He emphasized that tick-borne disease research has a significant absence of prospective studies, and the field would greatly benefit from more studies that specifically use a prospective design.

The Working Group recommended a revision of the recommendation as follows:

*Recommendation 4: Provide funding for studies, particularly prospective studies, that evaluate clinical similarities; mechanisms of pathogenesis; and common etiologies for Post-COVID Conditions (PCC), other post-infectious fatiguing illness, post-treatment Lyme disease, and chronic symptoms attributed to Lyme disease and other tick-borne diseases.*

*Rewording of Recommendation 5*
Monica suggested that this recommendation could potentially fall under the FACA section before praising the subcommittee’s focus on maternal and fetal pathogenesis as a research recommendation.

The Working Group did not recommend any revisions of the recommendation from the original language:
Recommendation 5: *Develop and maintain comprehensive biospecimen repositories (e.g., whole blood, sera, cerebrospinal fluid, maternal and fetal tissues and fluids, and autopsy specimens) for use in developing and/or improving diagnostic assays, both direct and indirect, and for research into transmission and pathogenesis, for broad applications including early diagnosis, distinction of current versus past infection, and for use in pregnancy and fetal outcome applications.*

**Vote on Clinical Presentation and Pathogenesis Subcommittee Priorities**

Vote on Recommendation 1: 13 in favor, 1 absent
	Vote on Recommendation 2: 13 in favor, 1 absent
	Vote on Recommendation 3: 14 in favor
	Vote on Recommendation 4: 14 in favor
	Vote on Recommendation 5: 14 in favorReview of Report to Congress Outline

Linden introduced the draft outline of the Report to Congress for Working Group members to discuss. The proposed structure will include a one-page Executive Summary, followed by the FACA request(s), then the individual chapters focused on subcommittee topic areas, and ending with a complete list of recommendations as a review for Congress.

Linden emphasized that there were many common themes in the Executive Summary that could be grouped together. The Executive summary would include:

Congressionally directed mandates
	Decrease regulatory burden and assist in getting products to market (possibly by authorizing an increased role of BARDA)
		Mechanism for continued monitoring of progress on recommendations from the Tick-Borne Disease Working GroupCreation of national programs
	Surveillance (tick species, diseases)
		Biorepositories
		“Big Data” registriesHealth justice
	Representation of all stakeholders in preparing national educational materials with improved clinician outreach
		Food labeling to protect patients with Alpha-gal Syndrome
		Improved access to care (telehealth)
		Occupational standards for high-risk occupations
		Understanding clinical presentation of tick-borne diseases in populations that are commonly under-evaluated (for example, prisoners, individuals in psychiatric facilities, migrant workers)Targeted funding for understudied areas of need
	Tick control and preventative agents
		Diagnostics
		Persistent symptoms of disease
		Vaccines
		Central nervous system/ psychiatric manifestations of disease
		Pregnancy/ fetal outcomes
		Alpha-gal Syndrome
		Tick-borne viruses
		Treatment for tick-borne viruses and persistent symptoms of Lyme diseaseBen suggested waiting until the Report to Congress had been drafted to write up an Executive Summary with relevant details. 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, commented that BARDA does not have any regulatory authority as does the FDA.

Chapters of Report to Congress

Linden provided a draft overview of the chapter content included in the Report to Congress, as follows:

**Chapter 1: Introduction and Background**

	Congressional Action
		Current State of Tick-Borne Diseases in the United States
		Epidemiology
			Current Data
			Changes Since the Establishment of the TBDWG
			Ongoing and New Challenges
		A Look Back – What We Have Achieved
		Common Threads from the 2018 and 2020 Reports
		Looking Ahead
		The Goal of the Final Report
			Final Report: Focus and Structure**Chapter 2: Methods******

	Subcommittees
		Federal Inventory
		Public Comment
		Minority Responses (if applicable)**Chapter 3: Tick Ecology******

	Background
		Major Challenges and Issues
		Tick Ecology, Environmental Change, and Range Expansion
		Tick Bite Prevention and Tick Control
		Host Behavior and Host-Targeted Control Methods
		New Innovations and Commercial Translation for Tick Control**Chapter 4: Clinical Presentation and Pathogenesis**

	Background
		Major Challenges and Issues
		Mechanisms of Pathogenesis
		Mental Health
		Neurologic and Neuropsychiatric Manifestations
		Pregnancy and Congenital Infection
		Lessons Learned from Post-COVID Sequelae
		Health Equity**Chapter 5: Diagnostics**

	Background
		Major Challenges and Issues
		Diagnostic Testing for Multiple Tick-Borne Diseases and Potential for Improvement
		Vector Testing for Endemicity and Patient Exposure
		“Omics” Approaches
		Opportunities for Personalized Medicine
		Current Availability of Patient Samples for Testing and Validation
		Challenges to Novel Test Commercialization**Chapter 6: Disease Prevention and Treatment**

	Background
		Major Challenges and Issues
		Rickettsial Infections
		Babesiosis and relapsing Fever/ *Borrelia miyamotoi*Infection
		Tick-borne Viruses
		Alpha-gal Syndrome
		Lyme Disease Prevention
		Lyme Disease Treatment**Chapter 7: Access to Care and Education**

	Background
		Major Challenges and Issues
		Health Inequity in Patients with Tick-Borne Diseases
		Patient-encountered Barriers to Health Equity
		Clinician-encountered Barriers to Health Equity
		Medical Educational Barriers to Health Equity**Chapter 8: Public Comment**

	Background
		Public Comment Organized by Subcommittee Topic Areas**Chapter 9: Looking to the Future**

	Encapsulation of 2022 Tick-Borne Disease Working Group Recommendations
		Future Directions
		Challenges and Opportunities**Chapter 10: Conclusion**
	**Appendices******Linden, Holiday, and Jim clarified that each chapter writing group should aim for their report to be 18-20 pages (double-spaced) or 10-12 pages (single-spaced) in length.

Jennifer asked Linden to clarify whether it would be beneficial to reference in each chapter the findings and priorities from previous Working Group Reports that have not been implemented or adequately addressed. Linden affirmed that such references would be relevant and important.

Betty requested clarity on where the FACA request(s) would appear in the final Report to Congress. Following a brief discussion, members generally agreed that the FACA section should appear under the “Congressional Action” section at the beginning of Chapter 1 to add context from the original creation of the Tick-Borne Disease Working Group via FACA.

Division of Report Writing

Linden used a whiteboard to document Working Group writing assignments for each chapter of the Report to Congress. The Executive Summary will be written once the majority of the chapters are written. Subcommittee co-chairs were assigned to write their respective subcommittee chapters (with volunteer consultation from other members). The following is a list of chapters and their respective writers and consultants.

Chapter 1 (Introduction/Background): Ben, Betty, Monica, Rebecca, Gaby, Leith

Chapter 2 (Methods): Rose Li and Associates (Contractor support)

Chapter 3 (Tick Ecology): Kirby and Robert (with Gaby and Jennifer)

Chapter 4 (Clinical Presentation and Pathogenesis): Ben, Leith, and Jennifer (with Rebecca, Betty, Sunil, and Monica)

Chapter 5 (Diagnostics): Monica and Todd

Chapter 6 (Disease Prevention and Treatment): Dennis and Sunil (with Monica and Jennifer)

Chapter 7 (Access to Care): Betty and Rebecca (with Leith)

Chapter 8 (Public Comment): Linden, Holiday, Gaby, and Jennifer (with Lauren)

Chapter 9 (Looking to the Future): To be written after completion of subcommittee reports

Working Group Q & A

Several Working Group members asked questions about the report writing process and Federal Inventory, as follows:

Jennifer asked whether a draft of the Report to Congress would be available for public comment prior to the final Report to Congress. Holiday confirmed with Lauren Overman, MPH, CPH, Public Health Analyst, Office of Infectious Disease and HIV/AIDS Policy, U.S. Department of Health and Human Services, that the July meeting presenting the first draft of the Report would be publicly live-cast on the web. This would provide an opportunity for public comment and input prior to the August and September meetings.

Jim explained that the final Report will be due no later than the middle of October to allow time for final processing. This includes circulating the Report to Federal agencies as an informational courtesy before the Report goes to Congress, but those agencies will not be able to make any substantive changes to the Report. Kirby C. Stafford III, PhD, Chief Scientist and State Entomologist, Department of Entomology, Center for Vector Biology & Zoonotic Diseases, The Connecticut Agricultural Experiment Station, suggested updating the timeline to reflect the October deadline, noting that a November meeting may not be necessary.

Gabriella Zollner (Romero), PhD, Program Manager, Deployed Warfighter Protection Program, U.S. Department of Defense, asked about the process for submitting minority responses. Jim clarified that they may be submitted after the Working Group votes on the individual chapters, and members can only submit a minority response if they voted against the chapter content. Jennifer highlighted the collaborative nature of the 2022 Working Group, which has focused largely on areas of consensus, and noted that she does not expect there to be many (if any) minority responses.

Jennifer inquired about the Federal Inventory presentation on Day 1. She raised the concern that the nine states selected for the survey do not include southern states (Virginia excepted), where there is also a high incidence and burden of tick-borne diseases and conditions. Ben described the selection process that led to the nine surveyed states as based primarily on incidence (number of cases per 100,000 people), but also on state-run programs to monitor and treat vector-borne diseases. He added that 10 states account for approximately 95% of all reported Lyme disease cases each year.

Report to Congress Graphics & Images

Meghan Walsh, PhD, Senior Associate, Center for Scientific Research, Rose Li & Associates, Inc., shared with the Working Group the graphic design and cover images for the 2022 Report to Congress. The Report would include photographs instead of icons on chapter opening pages and an easy-to-read layout, avoiding large text blocks. Patient stories would be emphasized and called out in the Report. Working Group members should reach out to suggest relevant patient stories for inclusion in the Report. Jennifer noted that the Public Comments section could serve as a source for patient stories.

Review of Meeting #21 (April)

Holiday provided Working Group members with a brief review of topics covered and accomplishments from the April meeting including:

Acceptance of Subcommittee Reports
	Approval of Recommendations
	Approval of the Draft Report Outline
	Identification of Chapter LeadsDiscussion of Next Steps and What is Expected for the July Meeting

Holiday outlined the next steps for the Working Group. Chapter leads should meet with staff from Rose Li & Associates, Inc. to determine writing support needs and begin drafting their chapters. The deadline for the initial chapter draft is July 1, 2022.

Holiday also reviewed the calendar of upcoming deadlines and meetings. The next Tick-Borne Disease Working Group meeting will take place in person (hybrid remote) in Washington, DC on July 19-20, 2022, during which time the Working Group will discuss the report outline, draft chapters, template, and recommendations. The public may attend virtually.

Adjournment

The meeting was adjourned at 4:18 pm Eastern Standard Time.

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

Tick-borne Disease Working Group
In alphabetical order:

**Co-Chair**

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

**Co-Chair**

*Linden Hu*, MD, Professor of Microbiology and Medicine, Vice Dean for Research, 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, Associate Editor, *Emerging Infectious Diseases* (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

*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

*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: Tick-Borne Disease Working Group Subcommittees**

Access to Care and Education
In alphabetical order:

**Co-Chair***Elizabeth (Betty) Maloney*, MD, President, Partnership for Tick-borne Diseases Education

**Co-Chair***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

*Holly Ahern*, MS, MT(ASCP), Associate Professor of Microbiology; Educator, patient advocate, researcher, and scientific advisor for Focus on Lyme Foundation

*Megan DuLaney*, MS, Senior Advisor in support of U.S. Department of State; Patient Advocate; Subject Matter Expert in military health, global health, and policy development and analysis

*Lorraine Johnson,* JD, MBA, Principal Investigator, MyLymeData; Subject Matter Expert in patient-centered health care policy, big data, patient registries, and innovative research; Chief Executive Officer, MyLyme.Org

*David Roberts*, MD, Associate Professor of Medicine; Dean for External Education, Harvard Medical School; Educator for clinicians, trainees, and the public

*Ginger Savely*, DNP, Provider specializing in the treatment of Lyme disease; Member, International Lyme and Associated Diseases Society; Speaker and author with a focus on Lyme disease

*Leith J. States*, MD, MPH, MBA, FACPM, Chief Medical Officer, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services

*Beatric Szantyr*, MD, Physician educator on Lyme disease and other tick-borne diseases; Member, Maine Center for Disease Control and Prevention Vectorborne Workgroup

**Changing Dynamics of Tick Ecology, Personal Protection, and Control**

**Co-Chair***Robert J. Miller*, PhD, National Program Leader, NP104 Veterinary, Medical, and Urban Entomology, Agricultural Research Service, U.S. Department of Agriculture

**Co-Chair***Kirby C. Stafford III*, PhD, Chief Scientist and State Entomologist, Department of Entomology, Center for Vector Biology & Zoonotic Diseases, The Connecticut Agricultural Experiment Station

*Jill Auerbach*, Chairperson, Hudson Valley Lyme Disease Association, Coordinator; Tick Research to Eliminate Diseases: Scientist Coalition

*Lars Eisen*, PhD, Research Entomologist, Division of Vector-Borne Diseases, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention

*Amanda Elam*, PhD, CEO and Co-Founder, Galaxy Diagnostics, Inc.

*Dina Fonseca*, PhD, Professor and Director of the Center for Vector Biology, Department of Entomology, Rutgers, The State University of New Jersey, New Brunswick

*Rebecca Trout Fryxell*, PhD, Associate Professor, Medical and Veterinary Entomology, Department of Entomology and Plant Pathology, The University of Tennessee Institute of Agriculture

*Holly Gaff*, PhD, Professor, Department of Biological Sciences, Old Dominion University

*Erika T. Machtinger*, PhD, Assistant Professor of Entomology, College of Agricultural Sciences, The Penn State University

*Lonnie Marcum*, PT, BSHCA, Physical Therapist; Health and Science Writer for LymeDisease.org

*Daniel Salkeld*, PhD, Research Scientist, Department of Biology, Colorado State University

*Pete D. Teel*, PhD, Regents Professor, Department of Entomology, Texas A&M University

*Stephen K. Wikel*, PhD, Professor and Chair Emeritus of Medical Sciences, St. Vincent’s Medical Center, Quinnipiac University

**Clinical Presentations and Pathogenesis**

**Co-Chair***Charles Benjamin (Ben) Beard*, PhD, Deputy Director, Division of Vector-Borne Diseases, Centers for Disease Control and Prevention

**Co-Chair***Jennifer Platt*, DrPH, Co-founder, Tick-Borne Conditions United

**Co-Chair***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

*Meghan Bradshaw*, Patient Advocate, Global Lyme Alliance, Center for Lyme Action

*Sue Faber*, RN, BScN, Co-Founder, LymeHope

*Brian Fallon*, MD, MPH, Director, Lyme and Tick-Borne Diseases Research Center, Columbia University

*Alison Hinckley*, PhD, Epidemiologist, Bacterial Vector-Borne Disease Branch, Centers for Disease Control and Prevention

*Jacob Lemieux*, MD, DPhil, Clinician and Researcher, Division of Infectious Diseases, Massachusetts General Hospital

*Tina Merritt*, MD, Provider, Allergy and Asthma Clinic of Northwest Arkansas

*Rhisa Parera*, Patient Advocate, Lyme360

**Diagnostics**

**Co-Chair***Monica E. Embers*, PhD, Associate Professor of Microbiology and Immunology, Director, Vector-Borne Disease Research, Tulane National Primate Research Center

**Co-Chair***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

**Acting Co-Chair**(during CDR Todd Myers’s deployment)

*Amanda Elam*, PhD, CEO and Co-Founder, Galaxy Diagnostics, Inc.

*John Aucott,* MD, Director, Johns Hopkins Lyme Disease Clinical Research Center; Associate Professor of Medicine, Johns Hopkins Medicine

*John Belisle*, PhD, Principal Investigator, Belisle Lab; Professor, Co-Director, Center for Metabolism and Infectious Diseases, Colorado State University

*John Branda*, MD, Associate Professor of Pathology, Harvard Medical School; Associate Pathologist, Associate Director, Microbiology Laboratory, Massachusetts General Hospita

*Tammy Crawford*, Founder and Executive Director, Focus on Lyme

*Liz Horn*, PhD, MBI, Principal Investigator, Lyme Disease Biobank; Principal, LHC Biosolutions

*Robyn Nadolny*, PhD, Chief, Molecular Biology Section and Tick-Borne Disease Laboratory, Laboratory Sciences Directorate, U.S. Army Public Health Center

*Rafal Tokarz*, PhD, Assistant Professor of Epidemiology, Center for Infection and Immunity, Columbia University Medical Center

**Disease Prevention and Treatment**

**Co-Chair***Dennis Dixo*n, PhD, Chief, Bacteriology and Mycology Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health

**Co-Chair***Sunil Sood*, MD, Chair of Pediatrics, South Shore University Hospital; Attending Physician, Cohen Children’s Medical Center; Professor of Pediatrics and Family Medicine, Zucker School of Medicine and Hofstra/Northwell

*Scott P. Commins*, MD, PhD, Associate Professor of Medicine and Pediatrics, Section Chief, Allergy and Immunology, University of North Carolina School of Medicine

*Gregory Ebel*, ScD, Professor, Colorado State University

*Erol Fikrig*, MD, Professor of Medicine (Infectious Diseases) and Epidemiology (Microbial Diseases) and Microbial Pathogenesis, Yale University for Global Health; Section Chief, Infectious Diseases

*Tony Galbo*, Advocate for Gabby’s Law; Member, Congressionally Directed Medical Research Programs Tick-Borne Disease Programmatic Panel, U.S. Department of Defense

*Peter J. Krause*, MD, Senior Research Scientist, Department of Epidemiology of Microbial Diseases, Yale University School of Public Health

*Charlotte Mao*, MD, MPH, Researcher and Physician, Dean Center for Tick-Borne Illness, Spaulding Rehabilitation Hospital

*Luis A. Marcos*, MD, MPH, Director, Infectious Diseases Fellowship Program, Stony Brook University; Associate Professor of Medicine, Microbiology, and Immunology, Stony Brook University Health Sciences Center School of Medicine

*Christopher Paddock*, MD, MPHTM, Pathologist, Rickettsial Zoonoses Branch, Centers for Disease Control and Prevention

*Paul Mead*, MD, MPH, Chief, Bacterial Diseases Branch, Division of Vector-Borne Diseases, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention

*Sam Perdue*, PhD, Section Chief, Basic Sciences and Program Officer, Rickettsial and Related Diseases, Bacteriology and Mycology Branch, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health

*Mark Soloski*, PhD, Professor of Medicine, Lyme Disease Research Center, Johns Hopkins University School of Medicine

*Charlie Stockman*, Patient Advocate

**Public Comment**

*Holiday Goodreau*, Executive Director, LivLyme Foundation; Co-creator, TickTracker

*Linden Hu*, MD, Professor of Microbiology and Medicine, Vice Dean of Research, Tufts University School of Medicine

*Lauren Overman*, MPH, CPH, Public Health Analyst, Office of Infectious Disease and HIV/AIDS Policy, Health and Human Services

*Jenifer Platt*, DrPH, Co-founder, Tick-Borne Conditions United

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

                    
  


Content created by Office of Infectious Disease and HIV/AIDS Policy (OIDP) Content last reviewed September 26, 2022Back to top
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