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                              April 27-28, 2022, TBDWG Meeting (online)
                              TBDWG April 27 - 28, 2022 - Meeting Summary - Day 1


    

    

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TBDWG April 27 - 28, 2022 - Meeting Summary - Day 1








  
  
    

  
      





April 27th, 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 the roll call (see Appendix 1: Tick-Borne Disease Working Group Members and HHS Support Staff). The meeting began with a quorum.

Update and Meeting 21 Goals

Holiday Goodreau, Executive Director, LivLyme Foundation; Co-creator, TickTracker; Working Group Co-Chair, provided a brief summary of the previous Working Group meeting. Linden Hu, MD, Tufts University School of Medicine, Professor Microbiology and Medicine; Vice Dean for Research; Working Group Co-Chair, presented the agenda for the meeting, which included a review of the subcommittee co-chairs' proposed recommendations, a vote on the recommendations for the Working Group Report to Congress, identification of chapter leads, and next steps to begin drafting the report. The full agenda for Day 1 of the Tick-Borne Disease Working Group is as follows:

Public Comments
	LymeX Update
	Vote to Accept Submission of the Subcommittee Reports
	Discussion and Vote on Recommendations Proposed by the Following Subcommittee Co-Chairs:
	Diagnostics
		Tick Ecology, Personal Protection and Control
		Disease Prevention and Treatment
	Federal Inventory UpdateLinden noted that the proposed recommendations presented in this meeting do not represent the full range of priority findings originally presented in the subcommittee reports; rather, they are a streamlined list of priorities the subcommittee co-chairs believe will have the greatest impact for the 2022 Report to Congress.

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.

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.

*Wesley Cochran*: Wesley presented a project he had initiated as a student at the University of North Carolina at Chapel Hill. He explained that he had conducted tick surveillance in municipal recreational areas near the university in conjunction with the VEER Hub, a multidisciplinary collaboration comprised of researchers and public health scholars at Chapel Hill. Wesley described his demographic report of tick density in the areas he had surveyed, and the fact sheet he created for public awareness. Wesley expressed interest in applying his work in K-12 public education to build public awareness of vector-borne disease.

*Caroline Ciocca*: Caroline explained that she had recently graduated from university and moved to North Carolina to enter the workforce in insurance and risk management. She was first infected with tick-borne disease at age 9 and reported being dismissed by her pediatrician despite a psychiatrist recommending a test for Lyme disease. She experienced years of debilitating symptoms until she was diagnosed with several tick-borne co-infections at age 23. Caroline commented that she currently suffers from joint pain, nausea, and neuropsychiatric symptoms, which make it difficult to work. She also reported employment difficulties due to her illness and high medical costs. She urged the Working Group to study tick-borne co-infections, update educational materials on government funded sites, and promote early prevention and treatment.

*Adina Bercowicz*: Adina stated that she is the founder and executive director of LymeTV. She noted that education is essential to prevent tick-borne diseases in the absence of vaccines and gaps in the availability of treatments and early interventions. Adina pointed out the lack of equity in the diagnosis of African-Americans, who she says often get diagnosed at later stages of disease. She advocated for free testing and treatment centers to mitigate socioeconomic disparities. She also advocated for tick-borne disease to be part of the mainstream K-12 health science curriculum. Adina requested that health inequities be addressed in the Working Group report and advocated for tick testing labs nationwide.

*Enid Haller*: Enid explained that she works at the Lyme Center at Martha’s Vineyard and was previously a member of a Tick-Borne Disease Working Group subcommittee. Enid promoted *The Quiet Epidemic,* afilm about Lyme disease. She also highlighted several other conferences and events during Lyme Disease Awareness month. Enid noted that although there has been progress in advocacy for tick-borne disease patients, many problems remain; she cited Lyme disease not being classified as a chronic illness, the lack of insurance coverage for Lyme disease treatment, doctors who treat Lyme disease losing their licenses, a lack of education about Lyme disease, and a lack of affordable care for Lyme patients. Enid lauded the growth of Lyme disease advocacy, citing thousands of social media groups promoting a diverse array of treatments. She also praised the Lyme disease centers for research at several universities and advocated for more research funding.

*Bruce Fries*: Bruce stated that he is president of the Patient Care advocacy group, which advocates for underserved and marginalized chronically ill patients. He explained that his group calls for improved diagnostics, clinical trials to evaluate treatments for persistent Lyme disease, research on seronegative Lyme disease, and research on co-infections. Bruce also advocated for research on the relationships between tick-borne diseases and psychiatric illness and between maternal-fetal transmission of Lyme disease and adverse birth outcomes. He also described his work with Mothers Against Lyme, which has collaborated with NIH to advance research on congenital Lyme disease. He called for the Working Group to recommend that Congress hold public hearings to monitor progress on tick-borne disease research.

*Andrea Jackson*: Andrea expressed dismay with the Working Group and claimed that the federal government was involved in sabotaging the Working Group’s efforts. Andrea also claimed that the Working Group was opposed to helping patients living with chronic Lyme disease.

*Carolyn Degnan:*Carolyn commented that she is the Chief Operations Officer of LymeDisease.org and the mother of two daughters with Lyme disease, including one who is disabled due to illness. Carolyn drew similarities between Long COVID and chronic tick-borne disease including difficulties finding treatment, the effect of disease on multiple physiological systems, and patient advocacy groups. She stated that Lyme disease patients must search for providers who will listen to them and consider their symptoms seriously. Carolyn advocated for the timely treatment of tick-borne disease to prevent the devastation and economic costs that long-term disease can cause.

*Kenton Pleger:*Kenton explained that he has had symptoms of Alpha-gal Syndrome (AGS) for 20 years but was only recently diagnosed. He noted that his primary care providers were unaware of AGS or how to treat it. Kenton underscored the importance of continuing education for health care providers about tick-borne diseases and conditions. Kenton is working with advocates to write legislation in Tennessee requiring providers to take continuing education courses, so they are better prepared to treat patients.

LymeX Update

Kristen Honey, PhD, PMP, Chief Data Scientist, Executive Director of InnovationX, provided a presentation on the events that led to the inception of LymeX, a partnership between public and private institutions to advance the study of tick-borne diseases. In 2015, advocates and research centers held conferences and events to convene stakeholders with the goal of devising innovative solutions that address tick-borne diseases. Kristen attributed these efforts in part to the foundation of the *21st Century Cures Act* which led to the creation of the Tick-Borne Disease Working Group. After the first Working Group report was published, HHS launched the Lyme Innovation Initiative, which brought together advocates, researchers, and federal partners. Since 2019, the HHS Office or the Assistant Secretary for Health (OASH) and the Centers for Disease Control and Prevention (CDC) have been co-leading the effort with Lyme Innovation to produce a National Strategy for vector-borne diseases. Partnering with the Steven and Alexandra Cohen Foundation, HHS launched Lyme Innovation Accelerator (LymeX) in October 2020 to advance tick-borne disease solutions in collaboration with Lyme disease patients, advocates, and stakeholders across academia, nonprofits, industry, and government.

Daniel Desautels, PhD, LymeX Innovation Fellow highlighted the three focus areas of LymeX:

Patient-Centered Innovation
	Education and Awareness
	Next Generation DiagnosticsDaniel provided an overview of accomplishments in the first year of LymeX, which included conferences, listening sessions, and workshops. LymeX interviewed hundreds of patients, crowdsourced dozens of ideas to improve education and increase awareness of tick-borne disease and received several public responses for information on diagnostic testing.

In the fall of 2021, LymeX hosted a diagnostics competition in partnership with the NASA Center of Excellence in Collaborative Innovation with the goal of producing for FDA approval a direct diagnostic test to measure active Lyme disease infections in people. This is a multi-phase, multi-year prize competition concluding in 2024. Kristen noted that patients and advocates are welcome to get involved at lymex.crowdicity.com, and researchers and entrepreneurs planning to apply can do so at lymexdiagnosticsprize.com

Vote to Accept Submission of Subcommittee Reports

The Working Group voted to accept submission of the five subcommittee reports:

Access to Care and Education
	Changing Dynamics of Tick Ecology, Personal Protection, and Control
	Clinical Presentation and Pathogenesis
	Diagnostics
	Disease Prevention and TreatmentLinden noted that the subcommittee reports would be made public after the Working Group vote. The subcommittees themselves had already previously voted to approve the material within each of their respective reports. The Working Group opted to vote to accept submission of all subcommittee reports. Jim recorded this vote as unanimous.

Review of Proposed Recommendations

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

Proposed Recommendations from the Diagnostics Subcommittee

Subcommittee co-chair Monica E. Embers, PhD, Associate Professor and Director of Vector-borne Disease Research, Tulane National Primate Research Center, presented three proposed recommendations for the Working Group to consider. Subcommittee 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, added comments, where relevant. The proposed recommendations are as follows:

*Proposed Recommendation 1: Assemble an Advisory Panel of experts in tick-borne disease diagnostics to promote evaluation and development of current and promising new diagnostic approaches.*

For this priority, the Working Group would recommend seven individuals to serve on a panel, under OASH, comprised of stakeholders from the academic, clinical, industrial, government, and advocacy sectors. The panel will convene from February 2023 to January 2025 with the goal of promoting the recommendations set forth in the Working Group report to Congress. Members would be expected to host an HHS-sponsored scientific conference to review promising proof of principle studies and applications of promising technologies, including direct and indirect detection methods, as well as host immune biomarkers that may facilitate diagnosis. The conference should include researchers, government personnel, investors, small businesses, large clinical labs, patient advocates, and diagnostics companies.

Monica explained that the rationale for this recommendation would be to engage all stakeholders in promoting new technologies and promising diagnostic tests for tick-borne diseases. Todd expressed interest in working with LymeX to help develop new diagnostic technologies.

*Proposed Recommendation 2: Mandate federal funding (CDC or NIH) to: (1) build a national biorepository of human samples supported by a national network of qualified labs & physician clinics; and (2) build a clinical and translational research program involving a network of clinical academic centers.*

These actions may fall under the example of Centers of Excellence in Lyme and Tick-Borne disease. Studies should cover prevention diagnosis, and treatment interventions.

Monica explained that the rationale for this second recommendation was to emphasize that biological samples should reflect patient populations and should be accompanied by thorough clinical case descriptions to adequately assess diagnostic test performance. Todd underscored the challenge of locating clinical samples and building biorepositories, which are essential for developing diagnostic tests.

*Proposed Recommendation 3: Create an innovation pipeline program for evaluation, registration, and commercialization of new tick-borne disease diagnostic strategies. Build on existing initiatives to stimulate interest and funding for tick-borne disease diagnostic strategies. Build on existing initiatives to stimulate interest and funding for tick-borne disease diagnostic development, including multiphase funding for promising new diagnostic approaches, and inclusion of tick-borne disease under the auspices of the Biomedical Advanced Research and Development Authority (BARDA) infectious disease portfolio.*

An increase in funding is recommended through targeted RFAs, SBIR/STTRs, CDMRP, and other federal funding mechanisms which are open to academic institutions and industry entities. The funding opportunities must promote inclusion of diagnostic tests that cover all stages of Lyme disease and additional tick transmitted infections. The creation of a category for use authorization is also recommended to accelerate commercialization of diagnostic tests, given the significant public health impact. Incentives should be provided for large diagnostic companies and clinical laboratories to engage with new technologies under development by academic investigators and small companies.

Monica explained that there is not an absence of new technologies or a lack of interest, but a lack of investment in the sustainable development of tests. This is a major gap hindering the transition of novel research findings into improved patient outcomes.

**Discussion of Diagnostics Subcommittee Proposed Recommendations**

Linden opened discussion of the Diagnostic Subcommittee proposed recommendations for comments and questions. The Working Group utilized a whiteboard to edit recommendations. Linden informed the Working Group that at end of the discussion, they would vote on the inclusion of each recommendation for the final report.

Jennifer Platt, DrPH, Co-founder, Tick-borne Conditions, recommended that, to be inclusive of AGS, the Working Group use the term “tick-borne diseases and conditions” in all recommendations. Linden suggested that tick-borne disease (including conditions) be defined at the beginning of the report. 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, proposed that each recommendation be worded broadly to achieve desired results.

Holliday Goodreau noted that only Congress can provide directives to federal agencies and suggested that one of the recommendations include a request to continue the tick-borne disease federal advisory committee (FACA). Charles Benjamin (Ben) Beard, PhD, Deputy Director, Division of Vector-borne Diseases, Centers for Disease Control and Prevention, clarified that in order to make formal recommendations to federal agencies, a FACA is legally required; alternatively, agencies can convene meetings with experts to discuss priority topic areas. Todd underscored that such meetings can be useful if they yield actionable results. The Working Group agreed that renewing a FACA for tick-borne diseases was a broader priority beyond any individual subcommittee recommendation. The Working Group decided to include a FACA recommendation in the opening of the final report.

*Rewording of Recommendation 1*

Elizabeth (Betty) Maloney, MD, President, Partnership for Tick-borne Diseases Education, noted that end users, including patient advocates, should be added to this recommendation. Monica agreed. Working Group members also discussed the possibility of naming a particular federal agency to facilitate the actions in this first recommendation. 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, advocated for leaving the language open-ended because many federal partners may be involved with implementing the Working Group’s recommendations. The Working Group revised the recommendation as follows:

*Convene a panel of stakeholders and experts in tick-borne disease diagnostics, including but not limited to researchers, government, investors, small businesses, large clinical labs, patient advocates, and diagnostic companies, with the goal of promoting the evaluation and development of current and promising new diagnostic approaches.*

The rationale remained unchanged.

*Rewording of Recommendation 2*

Jennifer noted that the second recommendation was applicable to the work of multiple subcommittees; the Working Group flagged it to help inform later stages of the report writing process. Based on the conversation in the previous recommendation, the Working Group agreed not to dictate which agency would be responsible for carrying out each action. The Working Group also opted for broader references to clinical and academic centers to ensure the recommendation can be applied to a number of examples. The revised recommendation is as follows:

*Recommend increases in federal funding (CDC or NIH) to: (1) build a national biorepository of human clinical specimens for tick-borne disease supported by a national network of qualified labs & physician clinics; and (2) build a clinical and translational research program involving a network of clinical and academic centers.*

The Working Group also edited the rationale to highlight the need for broad sampling of patient populations. It reads as follows:

*Samples which broadly reflect the patient populations and disease manifestations and are accompanied by thorough clinical case descriptions are needed to adequately assess diagnostic test performance.*

*Rewording of Recommendation 3*

The Working Group discussed whether BARDA should be named specifically in the recommendation. To ensure the inclusion of other federal agencies that could potentially help execute the recommendation, the Working Group opted to use broader language that does not name a specific agency. Gabriella Zollner (Romero), PhD, Program Manager, Deployed Warfighter Protection Program, U.S. Department of Defense, recommended streamlining the language and emphasizing use authorizations and incentives for developers of diagnostic tools.

The reworded recommendation reads:

*Provide federal support for tick-borne disease diagnostics through an innovation pipeline that addresses targeted funding opportunities, use authorization, commercialization, and implementation via relevant federal agencies.*

**Vote on Diagnostics Recommendations**

Vote on Recommendation 1: 13 in favor, 1 abstain
	Vote on Recommendation 2: 13 in favor, 1 abstain
	Vote on Recommendation 3: 13 in favor, 1 abstainProposed Recommendations from the Tick Ecology, Personal Protection, and Control Subcommittee

Subcommittee 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, presented four recommendations for the Working Group to consider. They are as follows:

*Proposed Recommendation 1: Minimize roadblocks and streamline the process for getting new tick bite prevention and tick control products to market. Solutions are needed that streamline and facilitate the process for bringing new products to market, which can be accomplished by support of the vector-borne disease division of the Biomedical Advanced Research and Development Authority (BARDA), charging Federal entities to work with industry to streamline regulatory pathways, enhance Federal funding mechanisms, and market education to support the adoption of new products.*

The rationale for this recommendation acknowledged the need for long-term research followed by commercial product development, and tasked federal agencies with using funding mechanisms to support these endeavors.

*Proposed Recommendation 2: Support from federal agencies for research on tick ecology towards more effective tick and tick-borne disease surveillance, tick control and tick bite prevention is inadequate. There is a need to better define the primary drivers of tick populations, tick pathogen prevalence, and geographic expansion of ticks and tick-associated diseases. Tick ecology is an important part of the One Health concept that also includes people and companion animals.*

The rationale for this recommendation recognizes the importance of research on tick and pathogen ecology, enzootic cycles of tick-transmitted agents, disease incidents, and epidemiology related to tick-borne disease. Kirby emphasized the need for the selection of appropriate tick bite prevention and tick control approaches. He also noted that the Tick Ecology, Personal Protection, and Control Subcommittee wanted to highlight and address the underfunding of research in tick ecology.

*Proposed Recommendation 3: Accelerate efforts to define and deploy tick bite prevention and tick control approaches and strategies. Given the timeline from basic proof of concept research to field evaluations, and to commercial development and availability the public, there is a need for continued support for evaluation and development of existing and novel strategies.*

Kirby noted that the rationale of this recommendation emphasizes the importance of regulatory approval and commercialization of tick bite prevention and tick control products.

*Proposed Recommendation 4: Occupational standards for employees at high risk of tick-borne diseases need to be implemented with additional education needed for providers and at-risk populations, including minority groups and broad stakeholder engagement, with an approach to health equity. The goal is to expand knowledge and increase adoption of tick bite prevention and tick control methods across all affected groups.*

One rationale for this recommendation is highlighting the importance of identifying high-risk occupations and activities that could expose people to tick-borne diseases. Kirby explained that another rationale was to underscore the importance of health care providers taking occupation and activities into account when assessing risk factors and symptoms in their patients.

**Discussion of Tick Ecology, Personal Protection, and Control Subcommittee Proposed Recommendations**

The Working Group decided to combine Priorities 1 and 3. The Working Group also decided to reorder the priorities; thus, the second recommendation was relabeled as Recommendation 1 and the aforementioned combined recommendation became Recommendation 2. The individual discussions on each recommendation are relayed below:

*Rewording of Recommendation 1*

Ben questioned how best to articulate the role of federal agencies in this recommendation. Kirby explained that some federally sponsored research on tick ecology had been done over the past several decades, but current federal support was insufficient. Thus, the Working Group agreed to emphasize the need for funding and moved supporting text into the rationale. The edited recommendation reads:

*Increase funding for research on tick ecology towards more effective tick and tick-borne disease surveillance and tick control. Tick ecology is an important part of the One Health concept that also includes people and companion animals.*

*Rewording of Recommendation 2*

Ben noted that that a similar recommendation has been made in the Vector-Borne Disease National Strategy, which focuses on agencies other than BARDA. In response, the Working Group agreed to reference federal agencies more broadly. Monica noted that education pertains to several different topic areas. Betty and Monica clarified that the reference to products relates to those validated by researchers. Gaby also recommended streamlining the language by making it broader.

In response to a question from Ben, Kirby confirmed that this recommendation involves both developing new tick bite prevention products and assessing preexisting ones. Gaby inquired what the difference was between the Subcommittee’s original recommendations 1 and 3. Kirby noted that Recommendation 1 involved bringing products to market while Recommendation 3 was meant to foster research and development. The Working Group decided to combine these two priorities. They also decided to reorder all of the recommendations to reflect the timeline of a product development cycle.

The new wording reads as follows:

*Increase efforts and funding to develop, evaluate, and deploy tick bite prevention and tick control approaches and strategies. Minimize roadblocks and streamline the process for getting new tick bite prevention and tick control products to market.*

*Rewording of Recommendation 3*

The Working Group discussed streamlining the language of this recommendation while also emphasizing the importance of educating providers about at-risk populations. Ben, Jennifer, and other Working Group members highlighted the differences between recommending occupational standards and mandating them and opted to keep this language broad. The reworded recommendation reads as follows:

*Increase adoption and expand knowledge of tik bite prevention and tick control methods across all affected groups, including implementation of occupational standards for employees at high risk of tick-borne diseases and conditions.*

**Vote on Tick Ecology, Personal Protection, and Control Recommendations**

Vote on Recommendation 1: 14 in favor
	Vote on Recommendation 2: 13 in favor, 1 abstain
	Vote on Recommendation 3: 14 in favorAllowing Editing of Recommendation Rationales

The Working Group briefly discussed whether the votes on recommendations allowed future editing of the rationales used to support them. None of the Working Group members objected to allowing rationales to be edited as long as all members are made aware of the revisions.

Proposed Recommendations from the Disease Prevention and Treatment Subcommittee

Subcommittee co-chair Dennis Dixon presented three proposed recommendations for the Working Group to consider. They are as follows:

*Proposed Recommendation 1: Improve surveillance and reporting of tick-borne diseases nationwide. Resources should be dedicated to enable a comprehensive national surveillance program for tick-borne diseases, coupled with consistent reporting to the CDC and local health departments. Additionally, this information should be part of an education program to increase awareness of tick-borne diseases among health providers.*

Dennis explained that the rationale for this recommendation was to put emphasis on surveillance, reporting, and education of tick-borne diseases in order to promote targeted prevention and timely, appropriate treatment.

*Proposed Recommendation 2: Increase options for tick-borne disease prevention. Increase funding to develop multi-pathogen vaccines, “anti-tick” vaccines, reservoir-targeted approaches to provide broad protection against different tick-borne pathogens. Research on stand-alone Lyme disease vaccines should look for alternatives to OspA-based approaches.*

The rationale for this recommendation is highlighting the importance of disease prevention. Dennis emphasized vaccines as an essential measure of protection. However, he underscored the fundamental problem in the market of disease prevention products, which does not allow for unprofitable yet essential products to protect public health. To address this problem, the recommendation was framed broadly, promoting the use of multi-pathogen vaccines.

*Proposed Recommendation 3: Develop and/or improve treatment for tick-borne diseases, especially tick-borne viruses and persistent symptoms for Lyme disease. Accelerate discovery, preclinical development of effective treatments for tick-borne diseases. Efforts should focus on current gaps in knowledge or available therapeutics, such as treatment options for tick-borne viruses and options for preventing PTLDS.*

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, provided the rationale for the Subcommittee’s third proposed recommendation. He underscored the importance of timely use of antibiotics; however, therapeutics are lacking for viral tick-borne diseases. Persistent symptoms of Lyme disease require a pursuit of new approaches and treatments.

Sunil provided a short presentation on the state of tick-borne disease treatment, which is addressed in the recommendation. He noted that doxycycline is underused for rickettsial diseases in children. He also highlighted the need to repurpose drugs for immunocompromised babesiosis patients. *Borrelia miyamotoi,*in turn, requires more study to treat patients. Tick-borne viruses also require further research, and none have reached the stage of testing in animal models. Allergy desensitization studies could be effective for AGS, but more research is also needed. For Lyme disease, early treatment is known to be effective; however, longer term symptoms develop in a subset of Lyme disease patients which have accumulated into potentially millions of people in the United States and highlight the importance of further research. Sunil also suggested that Lyme disease may be a contributor to the epidemic of psychiatric conditions in children. Congenital Lyme disease also requires more study.

**Discussion of Disease Prevention and Treatment Subcommittee Recommendations**

*Rewording of Recommendation 1*

Linden recommended using the term “tick-borne diseases and conditions” to capture syndromes like AGS. Ben noted that disease surveillance is done by states, rather than nationally, and recommended emphasizing the quality and completeness of that surveillance. The Working Group discussed the complexities of improving tick-borne disease surveillance at the state and regional level, which are inconsistent. Ben also highlighted the importance of using surveillance information to help educate providers and the public. The reworded recommendation reads as follows:

*Improve the quality, timeliness, and completeness of surveillance and reporting of tick-borne diseases nationwide. The resulting information should be used to educate health care providers and the public to prevent, diagnose, and treat tick-borne diseases.*

*Rewording of Recommendation 2*

Gaby commented that the first sentence is overly broad and could be open to interpretation. Monica worked with Dennis and Kirby to clarify the language around human OspA (outer surface protein) and reservoir-targeted approaches to more accurately capture the vaccine development recommended. Sunil noted that monoclonal antibodies should also be mentioned. Linden observed that Recommendation 2 focused on prevention and Recommendation 3 focused on treatment, which should be reflected in the wording. The revised wording is as follows:

*Increase funding to develop multi-pathogen vaccines, “anti-tick vaccines,” and new prevention strategies to provide broad protection against different tick-borne pathogens. Research on stand-alone Lyme disease vaccines should look for alternatives to human OspA-based vaccine approaches.*

*Rewording of Recommendation 3*

Holliday suggested adding examples from Sunil’s presentation of Recommendation 3. The Working Group also expressed interest in ensuring the inclusion of pediatric care, also part of Sunil’s presentation. Jennifer reminded the group to consider including other conditions besides Lyme disease. Dennis proposed a separate sentence to capture all possible post-treatment symptoms for further research. Sunil crafted a passage that includes several of the topics from his presentation for addition into the recommendation. Ben and Gaby suggested that the recommendation remain focused on treatment to differentiate it from other proposed recommendations. The Working Group also discussed the portrayal of Lyme disease within the recommendation to emphasize its prominence. The rewritten recommendation reads as follows:

*Accelerate discovery, preclinical and clinical development of effective treatments for tick-borne diseases. Increase funding for research into understudied areas of treatment for tick-borne diseases, including but not limited to pediatric neuropsychiatric illnesses, pregnancy outcomes in infected women, and persistent post-treatment symptoms—with emphasis Lyme disease—across all age groups.*

**Vote on Disease Prevention and Treatment Recommendations**

Vote on Recommendation 1: 13 in favor, 1 abstain
	Vote on Recommendation 2: 13 in favor, 1 abstain
	Vote on Recommendation 3: 13 in favor, 1 abstain2022 Federal Inventory Update

Meghan Walsh, PhD, Senior Associate, Center for Scientific Research, Rose Li & Associates, Inc., presented an update on the Federal Inventory, including a synopsis of the 2018 and 2020 cycles.

Objectives

The objectives of this inventory are similar to the 2018 and 2020 inventories with some additions. The objectives are:

Conduct a comprehensive inventory of tick-borne disease surveillance programs and funding at the federal, state, and local levels (new), and the private sector (new).
	Identify advances, overlaps, and gaps in tick-borne disease research.
	Provide the Tick-Borne Disease Working Group a written report on the national response to tick-borne diseases.The inventory report will be a companion document to the 2022 Report to Congress to inform the Secretary of HHS and Congress regarding existing gaps within the tick-borne disease landscape.

**Federal Agency Surveys**

The federal agency inventory will be similar in scope to the 2018 and 2020 Federal Agency Surveys, using a modified survey tool. These agencies include:

Centers for Disease Control and Prevention (CDC)
	National Institutes of Health (NIH)
	U.S. Department of Defense (DoD)
	U.S. Food and Drug Administration (FDA)
	U.S. Department of Agriculture (USDA)
	Centers for Medicare and Medicaid Services (CMS)Meghan noted there is a distinct CMS survey in development in response to Recommendation 9.6 in the 2020 TBDWG Report to Congress.

**State Surveys**

The tick-borne disease state surveys will be conducted in several states and around specific data sources. Meghan relayed these details below:

Due to time constraints and restrictions associated with the *Paperwork Reduction Act*, nine states with the highest incidence of tick-borne diseases will be surveyed: PA, CT, WI, MN, ME, NJ, DE, VA, NY.
	State surveys will use available CDC data from additional states with tick-borne disease incidence – for example: WV, RH, VT, NH, CA, MI.
	The state surveys will capture all CDC data available and survey information at the state and local level to provide a baseline state inventory of tick-borne disease programs and services.**Private Entity Surveys**

The private entity survey will be designed to capture levels of funding and collaborative initiatives, as detailed here:

Private organizations that provide funding for tick-borne disease research and/or programs will be surveyed.
	Inclusion in the survey process will be determined based on:
	Identification via the environmental scan (see below)
		Interviews with Working Group members and subject matter experts
	The goal is to gain an understanding of funding and collaborative initiatives in tick-borne diseases occurring within the private sector and across sectors.**Environmental Scan**

The inventory will also include an environmental scan, described as follows:

An environmental scan of basic, clinical, and translational research, 2018 to present, conducted in the U.S. regarding:
	Etiology
		Prevention
		Treatment
		Surveillance
		Diagnostics
		Duration of Illness
		Pathogenesis
		Access to Patient CareTimeline

Meghan provided a timeline for the development of the Survey:

April 1st — 30th: Project Development
	May 1st — June 15th: Data Collection
	June 15th — July 15th: Survey and Data Analysis
	July 15th — August 30th: Report Writing
	Final Report due August 31st: A comprehensive report on research and surveillance of tick-borne diseases in the United StatesAdjournment

The meeting was adjourned at 3:20 pm.

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 Hospital

*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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