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                              TBDWG May 15, 2018 - Meeting Summary


    

    

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TBDWG May 15, 2018 - Meeting Summary








  
  
    

  
      





Welcome and Roll Call / Recap of Public Meeting 4 / Meeting 5 Agenda and GoalsMission StatementOverview of Report to Congress and the HHS SecretaryDiscussion of and Vote on Report to Congress TemplateDiscussion of What We Agree onDiscussion of ControversiesDiscussion of Disease Vectors, Surveillance, and Prevention Subcommittee ReportBig-Themed Buckets for Writing the ReportDiscussion of Pathogenesis, Transmission, and Treatment Subcommittee ReportDiscussion of Access to Affordable Care Services & Support to Patients Subcommittee ReportDiscussion of Vaccines and Therapeutics Subcommittee ReportDiscussion of Other Tick-Borne Diseases and Co-infections Subcommittee ReportClosing Remarks / Appendix: TBDWG Members and HHS Staff

*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

John Aucott, MD, Associate Professor, Division of Rheumatology, Johns Hopkins University School of Medicine; Director, Johns Hopkins Lyme Disease Clinical Research Center; Working Group Chair, welcomed participants to the meeting and conducted roll call. The meeting started with a quorum (see Appendix for attendance).

Kristen Honey, PhD, PMP, Senior Policy Analyst, Office of Management and Budget, Executive Office of the President; Senior Research Scholar, Stanford University; Member, Stanford University Lyme Disease Working Group; Working Group Vice Chair, updated the working group with the following two recent staffing changes.

James (Jim) Burger, Senior Blood and Tissue Policy Advisor, Office of HIV/AIDS and Infectious Disease Policy, Office of the Assistant Secretary for Health, the U.S. Department of Health and Human Services, as the formal Designated Federal Officer for the Tick-Borne Diseases Working Group
	Kaye Hayes, Deputy Director, Office of HIV/AIDS and Infectious Disease Policy, Office of the Assistant Secretary for Health, the U.S. Department of Health and Human Services, as the Alternate Designated Federal Officer for the Tick-Borne Diseases Working GroupRecap of Public Meeting 4

Kristen provided a quick overview of public meeting 4. She noted that the six subcommittees worked hard for several months to pull together literature review and develop reports to help inform the working group and its 14 voting members. The subcommittees offered insights into gaps, opportunities, and potential actions to be considered by the working group. She noted that the working group will use the subcommittees’ reports, public input, and government inventory to prepare for the report to Congress. She reported that during meeting 4, Robert (Bob) Sabatino, Founder and Executive Director of Lyme Society Inc., and Commander Scott Cooper (Coop), PA, MMS, Senior Technical Advisor and Lead Officer for Medicare Hospital Health and Safety Regulations, Center for Medicare and Medicaid Services, the U.S. Department of Health and Human Services, volunteered to help revise and finalize the working group’s mission statement.

Kristen pointed out that all the subcommittee reports and meeting summaries are online in the exact format in which they were submitted and are available to the public at www.hhs.gov/ash/advisory-committees/tickbornedisease/reports/index.html. She noted that the subcommittees will not be active anymore, but that individual subcommittee members may be solicited to provide input to the working group as needed, and that all input will be provided in writing and will be made available to the public through Department of Health and Human Services (HHS) website.

Meeting 5 Agenda and Goals

Kristen noted that the focus of Meeting 5 is to determine how the working group will produce the report to Congress and HHS. During the meeting, the working group will identify areas of agreement and controversy, identify overlaps and synergies in subcommittee reports, discuss how to incorporate government inventories and public input, and decide the process for writing the report with specific actions and recommendations.

In introducing the topics to follow, Kristen pointed out the difference between mission and vision statements. She noted that a mission is something to be accomplished within the constraints of present-day reality; whereas a vision represents a utopia or perfect future state. She then turned the meeting over to Bob.

Mission Statement

Bob then presented the mission statement he and Coop had revised.

Proposed Mission Statement

“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 interagency 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 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.”

Led by Kristen, the working group discussed the wording of the statement, and decided to 1) replace “illness” with “disease,” and 2) add “clinicians” to the membership. Following the discussion, John asked the working group to vote on the revised mission statement. All of the working group members in attendance (10) voted yes to accept the mission statement with the two revisions.

Approved Mission Statement

“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 interagency 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 in the interest of the patient with tick-borne disease, clinicians, 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.”

Kristen then turned the meeting over to Jim.

Overview of Report to Congress and the HHS Secretary

Jim provided a brief overview of the *21st Century Cures Act* and explained the requirements and rules related to the working group’s report to Congress and the HHS Secretary.

He explained that the working group is required to

submit a report on its activities no later than two years after the enactment of the *21st Century Cures Act* (December 2016), and every two years after that;
	make recommendations to the Secretary regarding any appropriate changes or improvements to such activities and research; and
	solicit input from states, localities, and nongovernment entities.Jim pointed out that the report shall cover the following areas.

Ongoing tick-borne disease research, including research related to causes, prevention, treatment, surveillance, diagnosis, diagnostics, duration of illness, and intervention for individuals with tick-borne diseases
	Advances made pursuant to such research
	Federal activities related to tick-borne diseases, including epidemiological activities related to tick-borne diseases; and 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
	The working group meetings
	Comments received by the working groupHe noted that the working group shall submit a report to the Secretary; the Committee on Energy and Commerce of the House of Representatives; the Committee on Health, Education, and Labor; and the Pensions of the Senate; and that the report will be publicly available on the HHS website (www.hhs.gov/ash/advisory-committees/tickbornedisease/index.html).

Jim then explained that the working group’s upcoming activities will be focused on developing the report, and he stated the timeline of the process.

May 21, 2018: Writing the report begins
	June 21, 2018: Draft report with recommendations due
	July 6, 2018: Review and revision of report due
	July 20, 2018: Draft report released for HHS agencies, U.S. Department of Defense (DoD), and U.S. Department of Veterans Affairs (VA) for comment
	August 17, 2018: HHS agencies, DoD, and VA review due
	October 1, 2018: Document revision due
	November 1, 2018: Final HHS agencies, DoD, and VA clearance complete
	November 14, 2018: Revision and final desktop publishing complete
	November 21, 2018: Final review for typographical errors plus 508 compliance complete
	December 18, 2018: Submit final report to Congress
	December 18, 2018: Final report posted on the Tick-Borne Disease Working Group website for public commentDiscussion of and Vote on Report to Congress Template

After Jim’s presentation, Kristen asked Jennifer Gillissen (contractor), Kauffman & Associates, Inc. (KAI), to present the template KAI designed. Jennifer first showed three different templates with different styles. She then proposed the one that the KAI team developed based on extensive research and discussion with the working group leadership team. She explained that the proposed template is visually appealing, uses infographics and factoids effectively, and allows patient and clinician stories to stand out. She added that the template also includes an executive summary and a space for public comments in the back of the report. She noted that technical issue briefs can also be developed for more scientific information on a specific topic. She then turned the meeting back to the co-chairs for discussion.

Kristen reminded the working group members to keep different audiences in mind when writing the report, and noted that the report will be about 40-pages long. Patricia (Pat) Smith, President, Lyme Disease Association, asked if anyone has checked the effectiveness of different types of reports. Jennifer responded that visually appealing reports seem to be more impactful. Kristen commented that clear, succinct reports are generally more effective than those that are long and text-heavy. She added that images are often used in the Executive Branch of the U.S. government to convey messages, and they can be updated when needed.

The working group members then discussed the following topics related to their report.

Outline

The working group discussed how to condense the information provided by the subcommittees. John proposed a bucket list of key themes, which they would discuss later in the meeting.

Minority Response

Pat pointed out that the working group was created because there have been differences in perspectives, and that patients’ voices and treating physicians’ voices have not been presented. She noted that when disagreements occur, minority responses are necessary to ensure patients’ voices are heard, and that perhaps those issues should be focused on. Kristen clarified that minority responses will be discussed by the working group on a case-by-case basis. She suggested that some of the more controversial issues could be addressed directly in the report. To avoid pitting two points of view against each other, she suggested that the working group also present a third, creative solution or viewpoint for such issues.

Recommendations

Regarding specific recommendations in the report, Pat suggested that the group focus on those over which Congress has authority. Kristen acknowledged that Pat’s suggestion is a good approach to filter information and help pull out some of the recommendations to put in the report to Congress, and she noted that all recommendations by the working group will be included in the appendix.

Inventory

Dennis M. Dixon, PhD, Chief of the Bacteriology and Mycology Branch, the National Institute of Allergy and Infectious Diseases, the National Institute of Health, the U.S. Department of Health and Human Services, pointed out that the working group’s mission statement mentions using government inventories, which are not yet available to the working group. Kristen noted that the report will be submitted in December, and that the working group can set up for a more thorough review of the inventory and literature for the next report submission in 2020. She pointed out this is the working group’s first step, and they will continue to update and improve along the way.

Treatment Guidelines

Bob S. mentioned the two main Lyme disease treatment guidelines: Infectious Diseases Society of American (IDSA) Practice Guidelines and the International Lyme and Associated Diseases Society (ILADS) Treatment Guidelines, and pointed out the importance of developing a third set representing the patient’s perspective. Kristen clarified that it is not the working group’s charge to create guidelines, but the working group can recommend that a third set be developed.

Technical Brief

Wendy Adams, MBA, Research Grant Director, Bay Area Lyme Foundation, noted the importance of outlining what will be included in the technical issue briefs, as well as identifying the process for writing them.

Following extensive discussion, John asked the members to vote on the template Jennifer proposed. All the working group members in attendance (10) voted yes to accept the template for their report to Congress.

Discussion of What We Agree on

John then asked the working group to discuss how to develop the content of the report, starting with identifying important gaps, opportunities, and actions that all members can agree on, for example, the need for better diagnostics, multifaceted challenges associated with coinfection, and the need for patient-centered treatment approach. The group pointed out and discussed the following topics.

Prevention of tick borne diseases.
	Diagnostics (tests). Wendy noted that her subcommittee discussed both diagnostics and diagnosis, and she said that some members of her subcommittee think it is important to keep diagnostics and diagnosis separate. Charles Benjamin (Ben) Beard, PhD, Deputy Director of the Division of Vector-Borne Diseases, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services; Associated Editor, *Emerging Infectious Diseases*, agreed that the two are different.
	Diagnosis. The group discussed better diagnostic tools for different stages of Lyme diseases.
	Treatment. The group agreed that certain treatment protocols (e.g., treatment protocol for chronic/late Lyme, treatment for other tick-borne diseases individually or in combination with other coinfections, and treatment for diseases caused by newly recognized pathogens) need to be improved. They discussed the meaning of certain terminologies such as post-treatment Lyme disease syndrome (PTLDS) and chronic Lyme disease, and debated how to describe clinical outcomes (e.g., restore to health vs. how patients feel and function). Wendy suggested looking into the acute side of Lyme disease because there are a range of protocols with varied success rates. Pat suggested adding prophylaxis as a new category because there is a lot of disagreement.
	Education.
	Access to care.
	Increased funding. Responding to concerns from federal agency representatives on the working group about whether they can legally recommend increases in funding, Kristen clarified that the HHS Office of the General Council has stated that it is acceptable to do so.
	Allocating resources to look into the multi-faceted etiologies of chronic diseases where Lyme disease and other tick-borne diseases may be playing a role.
	Need for better surveillance such as integrated, standardized reporting criteria across states for vector/tick and human surveillance.
	Pathogenesis of all tick-borne infections.
	Better understanding of etiology and pathology of persistent symptoms in patients with tick-borne diseases after treatment.
		Leveraging centers of excellence for tick-borne diseases – multi-center approach.
	Big data, and multi-center studies.
	Leverage emerging technology (e.g., diagnostics) and innovations (e.g., crowd sourcing, prizes, public-private partnership).
	Catalyzing public-private partnership.
	Better partnership and cooperation to pursue big data and innovative solutions.
	The value of patient-centered outcomes and processes.In responding to a question from Wendy, Kristen clarified that the working group will be able to update and revise the list and priorities until December when the final report is due.

Discussion of Controversies

After a 10-minute break, the working group discussed areas of disagreement, both amongst the working group members and in the field. John suggested prioritizing the controversies. The group pointed out and discussed the following controversies.

Diagnosis of chronic Lyme disease.
	Definition of the disease, such as Lyme, PTLDS, and chronic Lyme disease. Kristen clarified that the working group can point out the controversies, but it is not charged with defining the terms. She suggested putting chronic Lyme and PTLDS in the “parking lot” for now.
	The role of persistent pathogenesis/infection in patients with persistent symptoms with or without antibiotic treatment.
	Surveillance case definition and how it is used for diagnostic purposes.
	Best approaches to developing safe and effective vaccines for humans, hosts, and tick-targeted pathogens.
	Transparency in government process.
	Treatment guidelines.
	Prophylaxis
	Transmission of tick-borne diseases, for example human to human, and transmission of co-infections, and other ticks. Kristen suggested putting this topic in the parking lot.
	Prioritization of funding.
	How to move beyond controversies and disagreements.
	Bias in peer-reviewed publications and the grant review system, as well as concerns about scientific rigor.
	Concerns about the grant review process in research
	Best labs for testing and assays (e.g., CLIA-approved labs and tests).
	Health and life insurance coverage for patients with Lyme disease and other tick-borne diseases.
	Education, which government agency should put out recommendations, (HHS, or CDC), and what type of educational programs should be provided.
	Treatments and patient safety. The group discussed risk-benefit considerations in Lyme disease treatment, incorporation of patient input in the decision-making process, as well as the etiology of the illness. They disagreed on what treatment options fall inside or outside the boundaries of safety and efficacy for all stages of Lyme disease.
	The severity of mortality and morbidity of tick-borne disease (e.g. suicide, mental health, and Lyme carditis).After discussing the controversies, the working group then discussed how to use the subcommittee reports to develop the working group report to Congress and HHS Secretary. John clarified that the subcommittee reports are not the working group report, but they are one of the resources the working group will use in writing its report. He noted that the working group will identify and combine areas of overlaps between the subcommittee reports, identify differences or controversies warranting attention, and discuss what to include from the six subcommittee reports. He asked the co-chairs of the subcommittees to prioritize their recommendations.

Discussion of What Should be Included from the Disease Vectors, Surveillance, and Prevention Subcommittee Report

Pat, co-chair of the Disease Vectors, Surveillance, and Prevention Subcommittee, presented the following high priorities selected from the subcommittee’s report.

Prioritized Issues and Potential Actions

Tick environment-habitat-host research.  Fund field studies to identify key factors that contribute to tick presence and abundance, and how they can be interrupted (for example, climate, landscape change, or control of host populations). Particular emphasis should be placed on funding vector surveillance studies that can be compared among sites and over time to improve our understanding of tick species distribution and abundance.  Fund research on enzootic cycles that sustain tick-borne pathogens in the natural environment, tick range expansions, and how they can be interrupted.  Also identify and investigate Lyme disease vectors and hosts outside of the major Midwest and Northeast Lyme disease foci, to inform the medical community about the true distribution of the Lyme disease pathogen and other tick-borne pathogens, especially in California and the Southeastern United States.
	Tick basic research.  Fund research on pathogen-binding receptors and regulatory factors that enable tick-borne pathogens to infect the tick tissues, proliferate, and survive for transmission to humans and animals.
	Field-trials and human studies evaluating effective natural tick-control products and natural skin repellents for tick control, tick bite, and human disease prevention (for example, use of skin lotions, soaps and repellents or tick control products containing Nootkatone or other botanically-based ingredients).
	Continued study and development of promising novel tick- and pathogen-control measures, including molecular technologies, for impacting pathogen prevalence in ticks and animal reservoir hosts (for example, rodent vaccination, transgenic ticks, RNAi, semiochemical control, and so forth), and promotion of private and public partnerships to engage industry and other professionals to develop novel and effective products that can be marketed to the public for tick-borne disease prevention.
	Have public health authorities formally recognize alternative, validated systematic approaches to tick-borne disease surveillance, such as systematic sampling of tick-borne disease reports for investigation, that reduce the burden on tick-borne disease reporters but allow for comparability of surveillance findings across states and over time.
	Public health authorities shall annually and when opportune (such as during Tick-Borne Disease Awareness Month) inform doctors, insurers, state and local health departments, the press and the public through official communication channels, including the MMWR, CDC and other official websites, that the Lyme disease surveillance criteria are not to be used for diagnostic purposes.
	To encourage commitment to establish a nation-wide tick and tick-borne disease surveillance network that is a partnership among public interest groups, academic institutions, and local, state, and federal government agencies to provide coordinated, standardized protocols for tick-borne disease surveillance, tick collection, identification, and analysis to identify established, emerging, and enzootic transmission cycles with zoonotic potential. Proposed network includes the coordination of local Mosquito and Tick Control Programs.
	Invest in programs that effectively link the best of tick science to peoples’ lived experiences with ticks (that is, Cooperative Extension, academic-based tick prevention resources, advocacy groups), and update existing regionally- and occupationally-relevant targeted public health intervention programs (including federal agency safety manuals and handbooks) to reduce physical and behavioral tick exposure risk by addressing specific gaps in knowledge and prevention (note: Pat and Ben explained that the word “already” triggered a minority response in their subcommittee’s report, and the co-chairs decided to take out the word to avoid excluding programs in underserved areas, and to support the best tool(s), which may or may not exist yet).Discussion

The group then discussed the priorities presented by Pat. Wendy noted that both ecology and epidemiology are important, and she pointed out the importance of education regarding regional differences. Richard Horowitz, MD, Director of the Hudson Valley Healing Arts Center; Member, World Health Organization’s Ad Hoc Committee for Health Equity, pointed out that education is one of the big themes and will be discussed again later, and he asked if it would be beneficial to highlight those areas that keep coming up and identify big themes early on to help write the report.

Ben and Pat selected the following as their high priorities.

**High Priority One:** Tick environment-habitat-host research. Fund field studies to identify key factors that contribute to tick presence and abundance, and how they can be interrupted (for example, climate, landscape change, or control of host populations). Particular emphasis should be placed on funding vector surveillance studies that can be compared among sites and over time to improve our understanding of tick species distribution and abundance. Fund research on enzootic cycles that sustain tick-borne pathogens in the natural environment, tick range expansions, and how they can be interrupted. Also identify and investigate Lyme disease vectors and hosts outside of the major Midwest and Northeast Lyme disease foci, to inform the medical community about the true distribution of the Lyme disease pathogen and other tick-borne pathogens, especially in California and the Southeastern United States.

**High Priority Two:** Have public health authorities formally recognize alternative, validated systematic approaches to tick-borne disease surveillance, such as systematic sampling of tick-borne disease reports for investigation that reduce the burden on tick-borne disease reporters but allow for comparability of surveillance findings across states and over time.

The group suggested discussing this topic in the education portion of the report (for example, inform clinicians of regional and specific risks related to tick-borne diseases).

Pat said that the co-chairs would like to add the following item to high priority 1.

Encourage a pipeline of innovation to science-based prevention education by providing additional funding for practitioners (both individuals and entities) proposing to conduct objective assessments of their intervention or tool.John pointed out that the item is similar to the following that Wendy had just outlined. Pat was open to accepting Wendy’s language, which she agreed is more concise:

**Education:** Inform clinicians of regional and specific risks related to tick diseases.The working group members in attendance (12) unanimously voted yes to include Wendy’s language in high priority one.

Considering the overlaps between the subcommittees, Pat asked the co-chairs to clarify whether the working group should be voting on recommendations now or after all the subcommittees have presented their recommendations. John clarified that the writing groups can address overlaps during the writing process. Kristen suggested discussing the big-themed buckets now to address the overlaps.

Big-Themed Buckets for Writing the Report

The working group agreed that it would be beneficial to identify big-themed buckets first. John proposed the following as themes.

Education (e.g., clinicians, patients, insurance, caregivers, state/federal legislation, medical boards)
	Surveillance (tick, human diseases)
	Diagnostic testing, pathogenesis, and treatment
	Access to care, preventionHe noted that other tick-borne diseases, vaccines, and therapeutics would be included in all buckets.

The group discussed the pros and cons of combining and separating different topics. Ben cautioned about the challenges of reorganizing and rewriting sections for the report within the short timeframe. Kristen and John clarified that the working group will not start from scratch; rather they will pull out content from the subcommittee reports. Kristen pointed out that a report organized using broad-level buckets might resonate more with the target audience. Wendy agreed with Kristen that it is important to keep the target audience in mind, and that the working group needs to find the best way to deliver the message and make recommendations. Coop and Bob pointed out the importance of education, which they thought should be a theme of its own.

After extensive discussion, the working group eventually decided to use the following topics as big themes for the report, which align well with the working group’s mission statement. They agreed that education and other tick-borne diseases will be included in each area. All attending working group members in attendance (12) unanimously approved the following themes.

Epidemiology and ecology
	Prevention
	Diagnosis
	Treatment
	Access to care, and patient outcomesAfter lunch break, John announced that the livestream of the morning session crashed for 15 minutes. He then briefly summarized the decisions made during the 15 minutes. He noted that because of the overlaps between the subcommittees, the working group decided to form five writing groups based on the five themes listed above. He pointed out that the new writing groups are largely parallel to the subcommittees. For example, the Epidemiology and Ecology writing group overlaps with the subcommittee on Disease Vectors. He pointed out that other tick-borne diseases and education will be included in each of the big themes. He clarified that vaccine will be included in the prevention writing group, and therapeutics will be included in the treatment writing group.

Discussion of What Should be Included from the Pathogenesis, Transmission, and Treatment Subcommittee Report

Wendy, co-chair of the Pathogenesis, Transmission, and Treatment subcommittee, then presented the priorities/key issues and potential actions her subcommittee identified.

Key Issues and Potential Actions

**Issue One:** What mechanisms of *B. burgdorferi* pathogenesis allow it to persist in some animal species despite a competent immune system and/or antimicrobial therapy? (What are the gaps in human research that need to be addressed to explore this model of pathogenesis in humans?)

**Potential Action One:**Promote research on animal models of *B. burgdorferi* infection and the mechanisms of disease processes in humans with an emphasis on pathologies that are currently lacking, e.g., neuroborreliosis

Insufficient understanding of mechanisms of disease in animal models, and need to understand how applicable these are to human disease**Potential Action Two:** Pursue further study of mechanisms of *B. burgdorferi*survival during infection processes and its tolerance to antibiotics and other stresses

Immune system is affected by *B. burgdorferi*to enable establishment and maintenance of infection in immunocompetent hosts
	Animal models and human case studies show that the pathogen may persist after antibiotic treatment
	If *B. burgdorferi*is still present, is that the etiology of continuing signs and symptoms?**Issue Two:** What is the pathogenesis of persistent symptoms in antibiotic-naïve and antibiotic-treated patients? Are there biomarker(s) to determine the continuing presence of infection? (What are the gaps in research regarding ongoing symptoms related to the effect of delayed diagnosis, immune dysfunction, persistent infection, co-infections and neural dysregulation?)

**Issue 3:** What is/are the best treatment regimens for acute Lyme disease, and for patients with ongoing symptoms who have or have not been previously treated? (Gap: What are the tools needed to measure treatment outcomes in Lyme disease, including but not limited to patient-centered outcomes, clinical practice outcomes, and innovative research tools?)

**Potential actions to address issues 2 and 3:**

**Potential Action:** Conduct clinical trials using more inclusive entry criteria representing the heterogeneity of patients seen in clinical practice and including different treatment approaches

Insensitive testing has led to a data set that may not be representative
	Current data from trials are not generalizable to clinical practice
	Utilize innovative patient-centered trial designs and big data tools to accelerate research; promote shared medical decision-making in clinical practice**Potential Action:** Develop and disseminate more comprehensive clinician education that highlights diverse symptomology, expanding geography of infecting ticks, and limitations of current testing procedures

Include diverse group of stakeholders, including clinicians, research scientists, and patients that represent the spectrum of scientific and medical expertise and perspectives on Lyme diseaseWendy then presented the prioritized actions.

Prioritized Actions

**Prioritized Action One.** Promote research on animal models of *B. burgdorferi* infection and mechanisms of disease processes in humans with an emphasis on pathologies that are currently lacking, e.g., neuroborreliosis

Insufficient understanding of mechanisms of diseases in animal models
	Need to understand how applicable these are to human disease**Prioritized Action Two.** Conduct clinical trials using more inclusive entry criteria representing the heterogeneity of patients seen in clinical practice and including different treatment approaches

Insensitive testing has led to a dataset that may not be representative
	Current data from trials are not generalizable to clinical practice
	Use innovative, patient-centered trial designs and big data tools to accelerate research
	Promote share decision-making in clinical practiceDiscussion

The working group discussed the challenges of clinical trial design (particularly inclusion criteria), execution, as well as data interpretation; and they revised the wording of the recommendations.

Clinical Trial Design

The working group discussed the many challenges associated with clinical trials, especially trials focused on Lyme disease, and they pointed to the need for different types of trials. Kristen pointed out the need for a centralized repository so that patients could find all trials that are available to them. Wendy highlighted the need for clinical diagnosis trials such as a trial on the erythema migrans (EM) rash to figure out why some patients develop a rash and others do not. Allen pointed out that patients with other tick-borne diseases and co-infections should be included in the clinical trials. Dennis mentioned Pharma’s role in clinical trials. John suggested expanding the types of trials, each of which has its own design. Rob S. suggested emphasizing and filling in gaps.

Inclusion Criteria

The working group debated the pros and cons of broadening inclusion criteria of clinical trials. While it is important to ensure that clinical trial participants represent real-world patients, members of the working group pointed out that removing cofounding variables is extremely important, and that it is impossible for one clinical trial to cover all patients. Dennis pointed out that inclusion criteria should be appropriated for the target population. Rob shared that one subcommittee member suggested inclusion criteria and clinical response geared toward considering patient subsets depending on their unique symptoms and experiences.

Data Interpretation and Application

Pat voiced concerns about the possibility that clinical trials could be used against patients, which, she mentioned, had happened in the past. Wendy recommended patient-centered approaches, for example including patients in the trial design process. Kristen added that clinical trials can be conducted in collaboration with trusted communities and organizations. Dennis pointed out the difference between a properly designed trial that does not ultimately support the hypothesis and a trial that is taken out of context.

Wording of the Recommendations

Rob S. mentioned that some of the sub-bullet points read like statements, not actions, and he suggested simplifying the language. Wendy noted that the statements are used to support the potential actions, and that she is open to revise the wording. John clarified that the working group is not asked during this meeting to debate over the wording; however, if members of the working group disagree with the content then they need to point that out.

After further discussion, the working group together revised the wording of Potential Action Two, and they decided to list additional topics discussed during the meeting as sub-bullet points so that the working group can discuss further in the report. Not all members agreed with the sub-bullet points. Kristen clarified that the working group members are not asked to vote on the sub-bullet points.

Recommendations and Votes

Kristen then asked the working group members to vote on the revised recommendations listed below. She clarified that the sub-bullet points are for further discussion in the report, and that they are not to be voted by the working group.

**Recommendation One:**Promote research on animal models of *B. burgdorferi* infection and mechanisms of disease processes in humans with an emphasis on pathologies that are currently lacking, e.g., neuroborreliosis.

**Recommendation Two:**Conduct additional clinical trials appropriate to the target populations where GAPS may exist.

**Voting Results:** The working group members in attendance (12) unanimously passed the two recommendations.

The following topics were discussed but were not voted by the working group members. They will be discussed in the report under the two recommendations.

Topics to be discussed under Recommendation One:

Survival during infection processes and its tolerance to antibiotics and other stresses
	Insufficient understanding of mechanisms of diseases in animal models
	Need to understand how applicable these are to human disease.
	Combine pathogenesis and influences of treatment
	The immune system is affected by *B. burgdorferi*to enable establishment and maintenance of infection in immunocompetent host.
	Animal models and human case studies show that the pathogenesis may persist after antibiotic treatment
	If *B. burgdorferi*is still present, is that the etiology of continuing signs and symptoms?Topics to be discussed under Recommendation Two:

Include children, pregnant women, patients with chronic Lyme disease, other tick-borne diseases, or co-infections; and keep geographic context into consideration
	Intensive testing has led to a dataset that may not be representative
	Current data from trials are not generalizable to clinical practice
	Utilize innovative, patient-centered trials designs and big data tools to accelerate research, and promote shared medical decision-making in clinical practice
	Leverage clinicaltrials.govDiscussion of What Should be Included from the Access to Affordable Care Services and Support to Patients Subcommittee Report

Coop, co-chair of the Access to Affordable Care Services and Support to Patients subcommittee, presented the potential actions his subcommittee identified. He pointed out that the subcommittee emphasized the importance of “affordable medical care,” and he noted that they were pleased to see that under-represented and high-risk populations (e.g., pregnant patients, children, the elderly, active military and their families, veterans, migrant farm workers, etc.) were discussed by the Pathogenesis, Transmission, and Treatment subcommittee, and will be covered in the report.

Proposed Recommendations

Coop then presented the proposed recommendations developed based on the prioritized potential actions.

Revert back to 2011 language on the CDC website that distinguished surveillance criteria vs. diagnostic criteria, and draw attention to footnote on the IDSA guidelines.
	Allocate increased funding for tick-borne disease in the area of research, treatment, and prevention (proportional to cancer, HIV/AIDS), and establish tick-borne disease centers of excellence (Centers of Excellence already exist to serve patients facing serious health and public health challenges ranging from autism to cancer to minority health disparities.
	Protection for students of all ages from discrimination and protection from job discrimination due to Lyme and other tick-borne diseases.Discussion

The working group then discussed how to protect students and all patients, and debated which organization or entity should provide links to treatment guidelines. Pat was particularly concerned with the lack of identification of discrimination against students with Lyme or other tick-borne diseases and wanted to include a recommendation directed the Department of Education to investigate and intervene.

Ben clarified that CDC does not provide links to any treatment guidelines, and that the 2011 language on the surveillance case definition was never drafted or modified for clinical diagnosis purposes. Dennis pointed out that NIH does not link to any treatment guidelines either.

Regarding protections, Pat suggested keeping the protection for children from discrimination in schools and protection from job discrimination as two separate recommendations.

Kristen noted that the National Guideline Clearinghouse website will be going down in July of 2018. She pointed out that federal government agencies (either CDC or NIH) need to look into the peer-reviewed treatment guidelines. Pat said that she hopes NIH will look into the issue because physicians trust the NIH, and they want to know policies on this topic. Rob S. commented that medical societies or organizations that make the guidelines should house and defend their own guidelines, and also brought up the GRADE system to assess guidelines, and the potential to refer to this grading system when posting guidelines to federal websites. Richard pointed out that it is important for the federal government to set the record straight. Kristen proposed developing one federal website to provide comprehensive, balanced content on Lyme and other tick-borne diseases.

The group revised the wording of the proposed recommendations and voted on the revised versions listed below.

Recommendations and Votes

**Recommendation One:**Create a federal repository for information on Lyme disease and other tick-borne diseases to encompass:

Revert back to 2011 language on the CDC website that distinguished surveillance criteria vs. diagnostic criteria.
	Draw attention to the footnote on the guidelines.**Action Item:** Find out if links can be made from HHS website to ILADS and IDSA guidelines.

**Voting Results:** Eleven of the 12 attending working group members voted yes to pass the recommendation. One member voted no and two members were absent. The bullet points listed under the recommendation were not voted by the working group, but will be discussed in the report.

**Recommendation Two: Allocate increased funding for tick-borne diseases in the areas of research, treatment, and prevention proportional to burden of illness and need.**

(Note: Phrasing regarding making funding “proportional to cancer and HIV/AIDS” spending was removed to avoid confusion and competition with other disease groups.)

**Voting Results:** All working group members in attendance (12) voted yes to pass the recommendation.

The following topics were discussed during the meeting, but were not voted on. They will be discussed in the report under Recommendation Two.

Establish tick-borne disease centers of excellence (centers of excellence already exist to serve patients facing serious health and public health challenges ranging from autism to cancer to minority health disparities.)
	Research and treatment
		Acute and chronic illness to include Lyme disease and other tick-borne diseases
		Clinical trials folded in this area**Recommendation Three**: Protection from job discrimination due to Lyme and tick-borne diseases

All working group members in attendance (12) voted yes to pass Recommendation Three.

**Recommendation Four:**Protection for students of all ages from discrimination due to Lyme and tick-borne diseases

All working group members in attendance (12) voted yes to pass Recommendation Four.

The following topics were not voted on, but will be discussed under Recommendation Four in the report to Congress.

Congress directs the U.S. Department of Education (DoEd) to investigate and establish policies that protect students with Lyme or other tick-borne diseases from discrimination and ensure equal access to education.
	Chronic illness may exist or be enforced under the Americans with Disabilities Act of 1990 (ADA). Be sure Lyme disease is recognized in that area for EoEd-504 and Individualized Education Programs (IEPs).
	Allow children who fall behind because of illness to catch up. Discuss the ability to accommodate with or without an IEP.
		Not administered in the same way throughout states and school districts.
	May be more enforcement issue with DoEd, would need to look into this to be sure mechanism is in place.Discussion of What Should be Included from the Vaccines and Therapeutics Subcommittee Report

After a short break, Dennis and Rob S., co-chairs of the Vaccines and Therapeutics subcommittee presented their prioritized issues and potential actions.

Prioritized Issues and Potential Actions

**Prioritized Issue One:**Human vaccines to prevent Lyme disease: Support for availability of human vaccine(s) for prevention of Lyme disease is a top priority

**Potential Action:** Identify current barriers to public and industry acceptance of vaccines for Lyme disease, and address concerns as part of the process; support continued development for human Lyme disease vaccines.

**Prioritized Issue Two:** Therapeutics for PTLDS

**Potential Action:** Continued research into the pathogenesis (that is, immune response, cross-reactivity, autoimmunity, bacterial persistence, co-infections, and other mechanisms) of persistent symptoms in patients who have received standard treatment regimens.

Discussion

The working group discussed the need for safe and effective vaccines, debated what the best approaches to developing such vaccines are, and discussed possible mechanisms to address safety concerns and restore trust. There was also discussion about expanding the focus of recommendations to other tick-borne diseases such as Powassen.

The co-chairs outlined the following as the epidemiological rationale for re-introduction of Lyme disease vaccine.

Expanding range of ticks
	Increasing number of cases
	Rising health care costsSafety Concerns

Pat voiced concerns over the safety of vaccines. Dennis pointed out that a recent study showed no adverse events. Pat noted that she didn’t think the previous process was transparent, and that patient trust was damaged. She said that she wants to see a Congressionally-directed FDA report presenting all of the science related to the mechanism of the LYMErix vaccine platform and “how those findings can affect any other OspA-based vaccines now or in the future.” She suggested convening a meeting of researchers to explain the problems and failures of the adverse events reporting system. She mentioned that even FDA’s slide decks pointed out the limitations of the serious AE reporting system.

Dennis pointed out that the subcommittee’s recommendations came out of regulatory oversight. He clarified that the subcommittee is not endorsing any particular study, rather just pointing out the need for vaccination. He mentioned that the subcommittee did not include all references because they did not have adequate time to do a thorough literature review.

Kristen commented that many people are not against vaccines, and that they are just concerned about the safety.

Building Trust

Pat pointed out that a new vaccine is currently in the regulatory approval process with a fast-track status. She expressed concern that if the working group recommends vaccines, the recommendation could be perceived as a seal of approval for the vaccine.

Kristen agreed that rebuilding trust is needed before moving forward. Wendy added that building trust first may save time in the long run. The working group discussed different models to uncover the truth, including a Congressional truth and reconciliation process, a U.S. Government Accountability Office (GAO) report, and a conflict resolution roundtable.

Need, Challenges, and Moving Forward

Dennis highlighted the need to validate the field and open a pathway to cost-effective preventions. Wendy pointed out that OspA-based vaccines do not prevent *Borrelia miyamotoi* disease (BMD), and she cautioned that if the first vaccine fails, the latter ones may be tainted.

Ben pointed out the increasing number of new cases of tick-borne diseases and the inadequate prevention measures currently in place. He agreed that safe and effective vaccines are needed and that transparency and trust need to be addressed. Given that regulatory approval process of a vaccine takes time, he asked why not consider building trust and remaining open to new vaccines with potentials to prevent thousands of cases of Lyme diseases simultaneously. He noted that these efforts can be combined with education about what the vaccine does and does not prevent.

Recommendations and Votes

After extensive discussion, the working group voted on the following recommendations.

**Recommendation One/Action:** Build trust by transparent mechanisms in which all stakeholders examine and discuss past vaccine activities and potential adverse events to inform future vaccine development for Lyme disease.

**Voting Results:** The majority of the attending working group members (10 of 13) voted yes to accept the recommendation, one voted no, and two abstained. One member was absent from the meeting.

**Recommendation Two:** Support safe and effective human vaccines to prevent Lyme disease with transparent mechanisms by which all stakeholders examine and discuss past vaccine activities and potential adverse events to inform future vaccine development in Lyme disease.

**Voting Results:** The majority of the working group members in attendance (11 of 13) voted yes to accept the recommendation, and two members voted no. One member was absent.

The working group also discussed the following topics, which were not voted on but will be discussed in the report.

Support for availability of human vaccine(s) for prevention of Lyme disease is a top priority.
	Identify current barriers to public and industry acceptance of vaccines for Lyme disease, and address concerns as part of the process.
	Achieve optional safety and efficacy
		Overcome the legacy of the LYMErix vaccine
	Support continued development for human Lyme disease vaccines.
	In addition to ensuring safety and efficacy, consider including children and people with symptoms of Lyme or other tick-borne diseases in clinical trials, and determining the timing of booster vaccines, if needed.
	Before introduction, involvement in the process by public and private entities (e.g., patients, medical providers, payers, academia, public health agencies, and industry) is needed to improve communication, address concerns, and develop broad-based support.
	Consider a two-tiered approach for vaccine development (i.e., in the short term, focus on vaccines on the horizon, and meanwhile continue research for vaccines that might have the potential of interrupting transmission)
	Open a pathway for cost-effective vaccine but not back any specific vaccine.**Recommendation Three**: Continued research into the pathogenesis (that is, immune response, cross-reactivity, autoimmunity, bacterial persistence, co-infections, and other mechanisms) of persistent symptoms in patients who have received standard treatment regimens for tick-borne diseases, including Lyme disease.

**Voting Results:** The working group members in attendance (13) unanimously voted yes to accept the recommendation.

Discussion of What Should be Included from the Other Tick-Borne Diseases and Co-infections Subcommittee Report

After a 10-minute break, Richard co-chair of the Other Tick-Borne Diseases and Co-infections subcommittee presented their proposed recommendations. The working group voted on the proposed recommendations following a brief discussion.

**Recommendation One:** Allocate resources to improve education, diagnostics (including transmission via the blood supply and pregnancy) and treatment of other tick-borne diseases and co-infections.

**Voting Results:** All attending working group members (13) voted yes to pass the recommendation.

The following topics under Recommendation One were not voted on but will be discussed in the report.

Educate health care providers, clinical testing laboratories, patients, and the general public — these could be conducted by a collaborative effort among medical agencies (e.g. HHS), and private medical and patient organizations, as well as knowledgeable clinicians and scientists.
	Create a tick-borne diseases and coinfections multi-site working group to have a collaborative, standardized approach to data collection and conduct longitudinal cohort natural history studies of sequelae or complications of treated infections.
	Develop flow charts or algorithms for clinical diagnosis and laboratory testing for acute and chronic illnesses.
	Promote independent validation of laboratory developed tests utilizing panels of control samples that are assessed blindly.
	Examine ways to optimize sampling (e.g. skin for *B. burgdorferi, Rickettsia* spp., *Bartonella*spp.)
	Expand the number of externally validated assays to provide complete coverage of other tick-borne diseases and coinfections.
	Educate health care providers on the use of doxycycline
	Doxycycline is first line treatment for all tick bites w/clinical symptoms suggestive of HGA or other associated tick-borne diseases.
		Drug of choice in all age groups: pediatric (under the age of 8), pregnancy (short courses). Rifampin is another choice in pregnancy (clinician judgement)
		Disseminate this information to HCP’s: standardized training modules, brochures, e-prescribing information
	Increase resources to improve diagnostics, broaden *Babesia* species testing panels (genetic diversity/multiple Babesia spp.).
	Provide health care education for not only Family practice/Internal medicine doctors, but subspecialists, re: signs/symptoms/risks/laboratory evaluation/treatment challenges of Babesiosis.
	Conduct laboratory research & clinical trials to evaluate new treatment regiments for Babesiosis. Resistance to standard regimens has been reported (medications/alternative medicine protocols), which increases morbidity & mortality.
	Improve public education on prevention tick bites, and educate health care providers on the signs/symptoms/transmission RF borrelia
	Diagnostics: expand routine testing panels (5% of the US population suffers from Chronic Fatigue Syndrome/Fibromyalgia)
	Treatment: Evaluate efficacy of treatment regimens against relapsing fever borrelia transmitted by hard/soft ticks, especially when different co-infections are present, as persistent infection has been reported
	Increase resources for research into effective treatment
	Conduct research (animal models) re: modes of transmission & whether persistence exists after an acute infection (Zika, WNV)
	Educate health care providers on non-specific signs/symptoms. Use doxycycline as 1st line therapy in children/pregnancy.
	Treat RMSF presumptively; never delay/stop treatment.
	Improve & expand diagnostic assays, increase range of species, explore how multiple pathogens interact (Lyme, *Bartonella*): Effect on immunity
	Conduct animal and human clinical trials to evaluate more effective treatment protocols, as *Bartonella*has been shown to persist despite single or combination therapy.
	Allocate resources to conduct research to determine the risk of transmitting multiple tick-borne pathogens via the blood supply.
	Review the role of overlapping causes of inflammation in LD patients, such as *Mycoplasma* infections and environmental toxins. These have both been associated with autoimmune phenomenon.
	Conduct research on the role of free radical oxidative stress and cytokine production during tick-borne infection. Downstream effects of inflammation may result in disabling symptoms. Allocate resources to conduct clinical trials to identify contributing causes and confounding factors.**Recommendation Two:** Improve the education and research on the pathogenesis of alpha-gal meat allergy.

**Voting Results:** The working group members in attendance (13) unanimously voted yes to the recommendations.

The following topics under Recommendation Two were not voted by the working group but will be discussed in the report.

Increase education and awareness of pre-diagnosis and counseling after diagnosis. Labeling on food may be inadequate.
	Increase funding for immunologic and animal model research to identify and better understand the tick proteins that cause alpha-gal meat allergyClosing Remarks

At the end of Day 1 meeting, John expressed appreciation for everyone’s effort and commented on the respect and collegiality the working group members showed to each other. He asked the working group members to think about which of the five big-themed areas of the report they would like to help write, and he noted that the work group will discuss the writing process during Day 2 of the meeting.

The meeting was adjourned at 6:52 PM.

Appendix: TBDWG Members and HHS Staff

TBDWG Members

**Chair***John Aucott,* MD, Associate Professor, Division of Rheumatology, Johns Hopkins University School of Medicine; Director, Johns Hopkins Lyme Disease Clinical Research Center

**Vice-Chair***Kristen Honey,* PhD, PMP, Senior Policy Analyst, Office of Management and Budget, Office of the Federal Chief Information Officer, Executive Office of the President; Senior Research Scholar, Stanford University; Member, Stanford University Lyme Disease Working Group

*Wendy Adams,* MBA, Research Grant Director, Bay Area Lyme (BAL) Foundation

*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*

*Commander Scott Cooper,* PA-C, MMSc, Senior Technical Advisor and Lead Officer for Medicare Hospital Health and Safety Regulations, Centers for Medicare and Medicaid Services, U.S. Department of Health and Human Services

*Dennis M. 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

*Richard Horowitz,* MD, Hudson Valley Healing Arts Center; member, World Health Organization’s Ad Hoc Committee for Health Equity

*Captain Estella Jones,* DVM, Acting Deputy Director, Office of Counterterrorism and Emerging Threats, U.S. Food and Drug Administration, U.S. Department of Health and Human Services. - *David Leiby,* PhD, Chief, Product Review Branch, Center for Biologicals Evaluation and Research, U.S. Food and Drug Administration, U.S. Department of Health and Human Services (temporary stand-in for Captain Estella Jones)

*Lise E. Nigrovic,* MD, MPH, Director, Population Health Sciences and Health Services Research Center of the Institutional Centers for Clinical and Translational Research, Boston Children’s Hospital; Chair, Pediatric Emergency Medicine Collaborative Research Committee, American Academy of Pediatrics

*Allen L. Richards,* PhD, Director, Rickettsial Diseases Research Program, Naval Medical Research Center, U.S. Department of Defense

*Robert Sabatino,* Founder and Executive Director, Lyme Society Inc.

*Vanila M. Singh,* MD, MACM, Chief Medical Officer, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services (absent)

*Patricia Smith,* President, Lyme Disease Association

*Robert Smith*, MD, MPH, FACP, FIDSA, Director and Co-Founder, Vector-Borne Disease Laboratory, Main Medical Center Research Institute; Director, Division of Infectious Diseases, Maine Medical Center

HHS Support Staff Present

**Designated Federal Officer***James Berger,* MS, MT (ASCP), SBB, Senior Blood and Tissue Policy Advisor, Office of HIV/AIDS and Infectious Disease Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services

**Alternate Designated Federal Officer***Kaye Hayes,* MPA, Deputy Director, Office of HIV/AIDS and Infectious Disease 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 HIV/AIDS and Infectious Disease Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services

*Debbie Seem,* RN, MPH, Public Health Analyst, Office of HIV/AIDS and Infectious Disease Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services

                    
  


Content created by Office of HIV/AIDS and Infectious Disease Policy Content last reviewed February 8, 2023Back to top
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