TBDWG September 12, 2019 - Meeting Summary

Welcome; New Member Introduction
Overview of Mission, Vision, Values
Update, Meeting 10 Objectives, Timeline
Subcommittee Updates
Topic Development Briefs
Public Comments
Federal Inventory
Next 2 Meetings; Summary of Decisions; Next Steps
Appendix 1: TBDWG Members and HHS Support Staff
Appendix 2: Subcommittees and Topic Brief Committee Members

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

James (Jim) 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 (HHS); Designated Federal Officer (DFO) for the Tick-Borne Disease Working Group, called the meeting to order and conducted roll call (see Appendix 1: TBDWG Members and HHS Support Staff). The meeting started with a quorum.

David Hughes Walker, MD, Professor, Department of Pathology, the Carmage and Martha Walls Distinguished University Chair in Tropical Diseases; Executive Director, UTMB Center for Biodefense and Emerging Infectious Diseases; Working Group Co-Chair, welcomed participants to the meeting and noted that one of the meeting objectives was to hear updates on the progress the Working Group and its subcommittees have made since the last public meeting (Meeting 9) on June 4, 2019.

Leigh Ann Soltysiak, MS, Owner, Principal, Silverleaf Consulting, LLC; Adjunct Professor, Stevens Institute of Technology, Entrepreneurship Thinking; Working Group Co-Chair, thanked Jim, HHS staff, and the support team for preparing the meeting. She welcomed all members of the subcommittees and the public, and she briefly reviewed the agenda.

New Member Introduction

Jim welcomed and introduced a new member of the Working Group, Kevin R. Macaluso, MS, PhD, Locke Distinguished Chair, Chair of Microbiology and Immunology, College of Medicine, University of South Alabama. Jim stated that Kevin’s term started on August 23, 2019, and that he replaces Robert (Bob) Sabatino whose term had recently expired. Jim thanked Bob for his previous service as a Working Group member and his continued contribution as a subcommittee member.

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 21^st 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.

Update, Meeting 10 Objectives, and Timeline

Leigh Ann noted that the Working Group strives to address all tick-borne diseases, help ensure inter-agency coordination, examine research priorities, evaluate advances made, and identify gaps in research related to tick-borne diseases.

She then highlighted the progress made since the Working Group’s last public meeting, including the establishment of eight subcommittees. She noted that the subcommittees would be reporting on the efforts they have made toward compiling information in their respective subject areas and completing their reports to the Working Group.

David then explained that the meeting objectives are to

• Hear subcommittee updates, topic development briefs, and public comments;
• Discuss how to use the briefs and public comments to develop the final report to Congress;
• Examine the Federal inventory and decide how to use it;
• Plan the Working Group’s next meetings; and
• Discuss and vote on some topics.

Leigh Ann pointed out that membership of the eight subcommittees is inclusive of patients, patient advocates, clinicians, and subject matter experts, whose knowledge and perspectives will help formulate the subcommittee reports. She then reviewed the timeline and highlighted the following important deliverables and dates leading up to the submission of the 2020 Tick-Borne Disease Working Group Report to Congress.

• Subcommittee preliminary reports due December 1, 2019
• Subcommittee final reports to Working Group due January 10, 2020
• Working Group meetings in late January and March 2020
• Working Group report to Congress due November 2020

Leigh Ann encouraged the subcommittees to complete their reports before the January 2020 deliverable date to ensure that the Working Group’s next meetings can take place and allow Working Group members adequate time to review and discuss the subcommittee reports and then develop their own report to Congress, due in November 2020.

David then transitioned the meeting to subcommittee updates.

Subcommittee Updates

The eight subcommittees, one by one, provided updates on the progress made since the June 4, 2019 public meeting (Meeting 9). Subcommittee Co-Chairs introduced members of their subcommittees (see Appendix 2 for complete Subcommittee membership), provided background information, explained the goals and key issues they plan to address in their subcommittee report to the Working Group, and shared specific plans to achieve their goals.

All eight subcommittees are using a similar approach to conduct their work. Specific methods and strategies used include the following.

• The subcommittees are formed following the guidance of the 21^st Century Cures Act. Membership of the subcommittees represents diversity of scientific disciplines and views, and subcommittee members include researchers, public health professionals, clinicians, patients, and patient advocates.
• All subcommittees conducted weekly or bi-weekly conference calls, during which they invited patients, patients advocates, and subject matter experts, including experts both within and outside the subcommittee, to provide information and share perspectives on issues pertinent to the subcommittee’s work.
• Members of the subcommittees collaborated and will continue to collaborate in developing their presentations and deliverables to the Working Group.

Alpha-Gal Subcommittee

Together, the three Co-Chairs of the Alpha-Gal Subcommittee presented the subcommittee’s work.

Leigh Ann first introduced herself, the other two Co-Chairs, and other members of the subcommittee and highlighted their expertise related to alpha-gal syndrome (AGS) and tick-borne diseases in general.

Report Goals

Leigh Ann noted that the overall objective of the subcommittee is its final report to the Working Group, and that the subcommittee has aligned its goals with the Working Group’s goals. The subcommittee, Leigh Ann noted, is taking an overarching approach to look at a number of important topics (for example, cause[s], treatment, and prevention of AGS). To achieve these goals, the subcommittee has sought input from subject matter experts, patients, and cross-functional stakeholders to enhance understanding of AGS; and they have identified areas of additional research need. Leigh Ann noted that the ultimate goal is to advance human protection and reduce human suffering.

Background and Identified Needs

Subcommittee Co-Chair Scott Palmer Commins, BS, MD, PhD, Associate Professor of Medicine & Pediatrics, University of North Carolina; Member, UNC Food Allergy Initiative, Thurston Research Center, then explained the characteristics of AGS, provided brief background information, and explained the special needs identified by the subcommittee thus far.

Distinct factors of AGS

• AGS is an allergic reaction to mammalian meat; some people may also be allergic to dairy, cheese, and gelatin.
• AGS is associated primarily with bites from the lone star tick.
• AGS is not currently recognized/reportable as a tick-borne disease by the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC).
• Symptoms of AGS may vary in individual pediatric and adult patients.
• AGS may significantly change a patient’s lifestyle, and co-factors (for example physical activity, alcohol, and stress) may affect individual allergic reactions and exposure as mammalian products are ubiquitous.
• AGS does not appear to be caused by a pathogen.

Factors of AGS similar to those of other tick-borne diseases

• AGS drastically affects the lives of the patients and their families and caregivers.
• Currently there are no FDA-approved therapeutic products for AGS; treatment plans are generally “off-label,” which may affect payer coverage, and/or part of clinical protocols.

Brief background and special needs

• AGS is an allergy that develops in response to tick bite(s); however, currently there is no evidence proving that it is an infectious disease or caused by a pathogen.
• Accumulating data suggest there is an increase in AGS incidence and an expanding geographic risk.
• Establishing an AGS diagnosis code and diagnostic marker(s) would further help the understanding of AGS prevalence.
• Including human tick-bite data in epidemiological investigations and linking them to clinical data would help overcome the limitations of current alpha-gal surveillance and risk assessment.

Major Challenges and Issues

Scott further explained that the subcommittee has identified the following major challenges and issues.

• More information is needed to develop educational materials and programs and to improve patient outcome, including the following.
  • Accurate diagnostic data on the scope and incidence of AGS
  • Knowledge of how to identify individuals pre-disposed to AGS
  • Treatment guidelines/plans
  • Validated resources related to foods and other products containing alpha-gal

Next Steps

Co-Chair Angel M. Davey, PhD, Program Manager, Tick-Borne Disease Research Program, Congressionally Directed Medical Research Programs, U.S. Department of Defense, noted that, moving forward, the subcommittee would continue seeking expert input, begin putting all information together, and start working on the Results section. The subcommittee, she added, was aiming to complete their report before the January 2020 deadline.

Babesiosis and Tick-Borne Viruses Subcommittee

Charles Benjamin (Ben) Beard, PhD, Deputy Director, Division of Vector-Borne Diseases, Centers for Disease Control and Prevention, HHS; Associate Editor, Emerging Infectious Diseases; Co-Chair of the Babesiosis and Tick-Borne Viruses Subcommittee, introduced himself, Subcommittee Co-Chair (Eugene Shapiro, MD, Professor of Pediatrics, Epidemiology, and Investigative Medicine at Yale University), and the other members of the subcommittee.

Subcommittee Goals

Ben explained that the subcommittee’s goals are to

• Review the state of the science regarding the epidemiology, ecology, diagnostics, treatment, and prevention of infections caused by Babesia spp., tick-borne relapsing fever spirochetal agents, and tick-borne viruses;
• Define key research questions and clinical and public health priority needs regarding these pathogens; and
• Provide input to the Tick-Borne Disease Working Group on potential recommendations to include in the Working Group’s report to Congress.

Proposed Change

Ben stated that the subcommittee was proposing to officially change the its name from “Babesiosis and Tick-Borne Viruses Subcommittee” to “Babesiosis and Tick-Borne Pathogens Subcommittee.” He explained the rationale for the proposed change, as follows.

• There are other important tick-borne agents that are not captured under any of the other subcommittees, such as tularemia and both hard and soft tick-transmitted relapsing fever agents.
• There are important needs related to these pathogens, and this subcommittee report would be an appropriate place to address them.

Pathogens Identified

Ben explained that, to date, the subcommittee had addressed the following eight pathogens.

• Babesia microti and Babesia duncani, which can cause babesiosis
• Borrelia hermsii, B. turicatae, and B. Parkeri, which can cause tick-borne relapsing fever
• Borrelia miyamotoi, which can cause Borrelia miyamotoi disease
• Bourbon virus, which can cause Bourdon virus disease
• Colorado tick fever virus, which causes Colorado tick fever
• Heartland virus, which can cause Heartland virus disease
• Powassan virus, which can cause Powassan virus disease
• Francisella tularensis, which can cause tularemia

Background

Ben reported that in 2017, 59,349 cases of tick-borne disease were reported to CDC, of which 2,368 were babesiosis cases, 230 tularemia cases, and 33 Powassan virus infections. However, he noted, there are significant gaps in the understanding of the ecology and emergence of some of these pathogens. He also stated that diseases caused by some of these pathogens can pose unique challenges for diagnosis and treatment.

Major Challenges and Issues

Ben noted that, so far, the subcommittee had identified the following major challenges and issues that they plan to address in their report.

• Better understanding of the ecology and natural history of babesiosis and tick-borne pathogens
• Improved surveillance for Babesia to capture species and travel history of patients
• Improved diagnostic assays, particularly for Borrelia miyamotoi
• Multiple-pathogen interaction within vectors and hosts and the subsequent impact on transmission
• Co-infections in patients and the impact on clinical symptoms, disease severity, and response to treatment, particularly in the case of B. miyamotoi and B. burgdorferi.

Next Steps

Moving forward, Ben explained, the subcommittee will

• Continue their efforts in identifying important issues, questions, and concerns that should be highlighted in the subcommittee report;
• Complete the Background and Methods sections of the report; and
• Begin working on the Results and Potential Actions section.

Motion and Vote

David made a motion to accept the proposed change to the subcommittee title. Working Group member Pat Smith, President of Lyme Disease Association, seconded the motion. Members of the Working Group generally agreed that the change is appropriate, and they unanimously voted yes to accept the change.

Decision item: The Working Group unanimously agreed to change the title of “Babesiosis and Tick-Borne Viruses Subcommittee” to “Babesiosis and Tick-Borne Pathogens Subcommittee.”

Discussion

In response to a question regarding Powassan virus disease, Ben clarified that both neuroinvasive and non-neuroinvasive cases are reported to CDC; however, because neuroinvasive types are more severe, they are more likely to be treated and thus reported. He noted that he will find out if the number of reported cases is broken down into the two different types in CDC’s Morbidity and Mortality Weekly Report (MMWR).

When asked whether or not the subcommittee would provide information in its report about the differences in ecology and distribution of the different pathogens that causes babesiosis, Ben replied that the subcommittee will strive to capture all such granularities.

Clinical Aspects of Lyme Disease Subcommittee

Sam T. Donta, MD, Professor of Medicine (retired); Consultant, Infectious Diseases, Co-Chair of the Clinical Aspects of Lyme Disease Subcommittee, updated the Working Group on their progress.

Goals and Issues to Be Addressed

Sam noted that the Subcommittee’s main goal is to identify gaps in current clinical research related to the persistence of Lyme disease, and that the subcommittee plans to address the following major challenges and issues in its Report to the Tick-Borne Disease Working Group.

• Differential diagnosis of persistent Lyme disease
• Laboratory-related issues in the diagnosis of persistent Lyme disease
• Other diagnostic modalities (for example, single-photon emission computerized tomography [SPECT] and positron emission tomography [PET] scans)
• Treatment-related issues
• Non-tick transmission, including congenital and intrapartum Lyme disease and sexual transmission

Next Steps

Sam explained that, moving forward, the subcommittee would continue conducting conference calls and hearing presentations from more experts in the field.

Ehrlichiosis and Anaplasmosis Subcommittee

Subcommittee Co-Chair David updated the Working Group on the progress made by the Ehrlichiosis and Anaplasmosis Subcommittee since the June 4, 2019 public meeting.

Goals

David explained that the goals of the Subcommittee’s report are to

• Describe the health impact of human anaplasmosis and ehrlichiosis in the U.S.;
• Determine the obstacles to reduction in the morbidity and mortality of anaplasmosis and ehrlichiosis in the U.S.; and
• Identify gaps in knowledge and implementation that research may resolve.

Issues to Be Addressed

David stated that the subcommittee plans to address the following important issues in the context of ehrlichiosis and anaplasmosis.

• Surveillance
• Clinical diagnosis
• Laboratory diagnostics
• Treatment
• Prevention

David further explained the specific challenges and issues identified by the subcommittee.

For Ehrlichia chaffeensis, E. ewingii, and E. muris eauclairensis, David pointed out that human monocytic ehrlichiosis caused by E. chaffeensis is a life-threatening disease. Clinical diagnosis of the disease is challenging; and the utilization of laboratory diagnostics, accurate clinical diagnosis, and reporting of cases are inadequate. Passive surveillance and misdiagnosis resulted in estimated 50-fold underreporting. Seroprevalence of 8-20% in the regions with high prevalence of lone star ticks indicates underdiagnosis. Cross reactive serology among Ehrlichia confounds diagnosis. Reliable laboratory diagnostic tests are not available during the acute stage of the disease, and currently there is no vaccine for the disease.

For anaplasmosis, David noted that cases have more doubled in recent years. Passive surveillance has led to underreporting by an estimated 11-fold. Similar to other tick-borne diseases, clinical diagnosis of anaplasmosis is challenging. Seroprevalence data and prevalence of anaplasmosis in deer ticks together suggest high incidence of infection. In addition, the prevalence is confounded by a deer-specific strain A. phagocytophilum that does not infect humans.

Next Steps

David noted that, moving forward, the subcommittee would develop specific suggestions for the Working Group to consider when developing their recommendations and report to Congress and the HHS Secretary.

Pathogenesis and Physiology of Lyme Disease Subcommittee

Subcommittee Co-Chair Sam T. Donta updated the Working Group on the progress made by the Pathogenesis and Physiology of Lyme Disease Subcommittee since the June 4, 2019 public meeting.

Goals and Background

Sam explained that the subcommittee has been discussing and plans to address the following questions in their subcommittee report.

• What are the initial events and mechanisms involved in the entry of B. burgdorferi into host tissues?
• What are the events and pathophysiology after the entry of B. burgdorferi into host tissues?
• What are the pathogenic and pathophysiologic mechanisms involved in the development of symptoms and signs?
• What underlies the persistence of Borrelia in host tissues?
• Does autoimmunity play a role in the course of persistent symptoms?
• Do antibiotics play a role in “resistance” to successful antibiotic treatment, and how are biofilms involved in antibiotic resistance?

Sam explained that the subcommittee strives to establish what is known about the mechanism underlying the pathophysiology of Lyme disease, and to address persistent Lyme disease in a meaningful way that leads to tangible next steps for improving patient care.

Major Challenges and Issues to Be Addressed

Sam noted that the subcommittee plans to address the following topics and questions in its report to the Working Group.

• Mechanisms that lead to transmission of the bacteria from ticks to hosts and mechanisms of their persistence
• In vivo detection of persistent B. burgdorferi
• Role of B. burgdorferi peptidoglycan persistence in the pathogenesis of Lyme arthritis
• The question of whether or not inflammation in patients with persistent symptoms of Lyme disease is driven by low-level persistent infection or a dysregulated immune response

Next Steps

In the following months, Sam explained, the subcommittee plans to hear more presentations from subject matter experts on a number of topics that could help the subcommittee address some of the issues discussed above.

Rickettsiosis Subcommittee

Co-Chair David Walker updated the Working Group on the progress made by the Rickettsiosis Subcommittee since the June 4, 2019 public meeting.

Goals

David briefly reviewed the history of Working Group. He then explained that the goals of the Rickettsiosis Subcommittee report are to

• Describe the health impact of tick-borne rickettsial diseases in the U.S.;
• Determine obstacles to reduction of the morbidity and mortality caused by tick-borne rickettsial diseases in the U.S.; and
• Identify gaps in knowledge and implementation that could be resolved by research.

Issues to Be Addressed

David noted that the subcommittee plans to address the following important issues within the context of rickettsiosis.

• Species of Rickettsia pathogens in the U.S.
• Epidemiology
• Surveillance, both clinical and environmental
• True incidence of the diseases
• Prevalence of lone star ticks in different geographic areas
• Point-of-care diagnostic tests
• Treatment of children under 12 with doxycycline
• Undertreatment versus overtreatment
• Public and clinician education

David further explained the following major challenges and issues that are currently being discussed by the subcommittee and will be addressed in the subcommittee’s report to the Working Group.

• More than 6,000 cases of tick-borne spotted fever rickettsioses according to passive surveillance; however, 99% of the reported cases are not confirmed.
• Serologic diagnosis does not distinguish differences among the five spotted fever group rickettsioses, which may all stimulate the production of antibodies but lead to markedly different outcomes, ranging from subclinical infection to a 23% fatality rate without appropriate treatment.
• Case diagnostic reporting criteria likely includes many patients who do not have active tick-borne rickettsial infection.
• In regions with the presence of lone star ticks, about 10-20% of healthy persons have anti-spotted fever group rickettsial antibodies.
• Passive surveillance often results in many unreported cases.
• There is no easily available test for diagnosis of acute infection.
• Many physicians lack awareness of the illness and knowledge of appropriate treatment options.
• Clinical diagnosis is challenging early in the course of the illness.
• Only certain antibiotics are effective in treating this group of diseases.

Next Steps

Moving forward, David stated, the subcommittee plans to develop specific suggestions for the Working Group to consider.

Discussion

A member of the Working Group asked if the subcommittee plans to address challenges associated with geographic diagnosis of Rocky Mountain spotted fever. David responded that the topic is under discussion. The previous week, he added, the subcommittee had heard two presentations on clinical diagnosis from the clinician’s perspective.

In response to comments regarding potential overlaps between different subcommittees, David noted that the Working Group will address the overlaps.

Regarding recommendations on education, David shared that the subcommittee has developed a list of strategies; however, they have yet to clearly identify any that are under Congress’s purview.

Tick Biology, Ecology, and Control Subcommittee

Kevin R. Macaluso, PhD, MS, Locke Distinguished Chair, Chair of Microbiology and Immunology, College of Medicine, University of South Alabama, updated the Working Group on the progress made by the Tick Biology, Ecology, and Control Subcommittee since the June 4, 2019 public meeting.

Goals

Kevin introduced members of the subcommittee and explained that the subcommittee’ goals are to

• Analyze information on tick biology, ecology, and control related to tick-borne disease;
• Review how biological and ecological drivers of tick populations may be affecting existing control technologies used to manage tick-borne disease transmission;
• Conduct a gap analysis of national tick biology and ecology research strategies and implementation capacity for effective tick control that can mitigate the health burden of tick-borne disease.

Kevin noted that one priority issue to consider is advancing integrated tick management by taking an area-wide approach in order to disrupt tick-host-pathogen interactions. This initiative, he stated, presents a great opportunity for preventing tick-borne disease morbidity and mortality.

Challenges and Issues to Be Addressed

After providing a brief background on tick-borne disease, Kevin reported that the subcommittee plans to address the following topics in their subcommittee report.

• Drivers for the increase in tick-vector populations
• Drivers for the geographic range expansion of tick vectors
• Risks associated with the entry of foreign tick vectors and disease-causing agents into the U.S.
• Potential benefits of emerging tick-control technologies
• Barriers for innovation in area-wide, integrated tick management

Next Steps

Moving forward, Kevin explained, the subcommittee will

• Assimilate shared knowledge and review scientific literature;
• Utilize the expertise of the membership to identify causes of the increase tick-borne disease within the context of tick biology and ecology; and
• Make recommendations that will emphasize research and development work aiming to reverse the trends in tick-borne disease.

Kevin noted that the subcommittee considers the following as a fundamental topic.

• Utilizing area-wide integrated management interventions targeting vector-host-pathogen interactions to disrupt the vulnerabilities in the biology and ecology of ticks

Discussion

In response to a question regarding the military’s effort in developing a new tick repellent, Co-Chair Adalberto (Beto) Pérez de León, MS, PhD, Director, Knipling-Bushland U.S. Livestock Insects Research Laboratory, United States Department of Agriculture—Agricultural Research Service, responded that the subcommittee will report recent developments. In addition, he noted, the Federal inventory could shed some light on this topic as well.

Training and Education Subcommittee

Commander Rebecca Bunnell, MPAS, PA-C, Senior Advisor, Learning and Diffusion Group, Innovation Center, Centers for Medicare and Medicaid Services, HHS, Co-Chair of the Training and Education Subcommittee updated the Working Group on the subcommittee’s progress since the June 4, 2019 public meeting.

Goals

Rebecca first introduced members of the subcommittee. She then explained the goals of the subcommittee report, which are to

• Delineate obstacles preventing health care providers from providing prompt diagnosis and optimal treatment, and suggest viable solutions for congressional consideration and action;
• Delineate obstacles that prevent patients from receiving prompt diagnosis and optimal treatment given their stage of disease, and suggest viable solutions for congressional consideration and action;
• Delineate reimbursement obstacles and suggest viable solutions for congressional consideration and action;
• Identify deficiencies in training for health care providers and suggest revisions for federally sponsored educational resources; and
• Identify deficiencies in patient and public health education, and suggest revisions for federally sponsored educational resources.

Focuses

Rebecca noted that the subcommittee will focus on the following issues.

• Access to care for patients with Lyme and other tick-borne diseases
• Reimbursement for patients with Lyme and other tick-borne diseases

• Clinician training for Lyme and other tick-borne diseases
• Patient and public health education on Lyme and other tick-borne diseases
• Diagnostic errors, particularly factors related to delayed diagnosis and misdiagnosis, including inappropriate psychiatric diagnosis
• Shared medical decision making

Major Challenges and Issues to Be Addressed

Rebecca further explained that the subcommittee members plan to address the following issues and questions in their subcommittee report.

• How to identify factors that delay early diagnosis and treatment
• How variance in treatment guidelines impact accurate diagnosis and treatment
• How delayed diagnosis impacts treatment outcomes and costs
• The role of shared medical decision making in diagnostic and treatment approaches
• Misdiagnosis by geography
• How educational resource content development and approval process, as well as information distribution, impact treatment
• How variance in guidelines and lack of peer review and stakeholder input on educational curriculum in training programs and continuing education for clinicians affect diagnosis, treatment, and prevention
• How geographic restriction, such as definition of high incidence states in case definitions/guidelines, and misuse of surveillance criteria impact treatment (for example, for establishing clinical diagnosis or providing standards for reimbursement)
• How government laws, policies, and procedures impact treatment

After Rebecca’s presentation, Co-Chair Pat Smith explained the methods the subcommittee members were using to conduct their work and reported the subcommittee’s next steps.

Next Steps

In the coming months, Pat elaborated, the subcommittee will

• Consider inviting two more speakers;
• Divide topics and assign subcommittee members to focus on individual topics;
• Write a report to address the subcommittee’s goals, important issues, and major challenges;
• Suggest recommendations for Federal action;
• Decide on peer-reviewed publications to be cited in the report; and
• Ensure that the subcommittee report also reflects minority opinions.

Proposed Change to the Subcommittee Title

Pat stated that the subcommittee proposes to change the subcommittee’s title from “Training and Education” to “Training and Education, Access to Care and Reimbursement.” Pat pointed out the following reasons for this change.

• Discussions at the last Working Group meeting covered training, education, access to care, and reimbursement.
• The objective of the legislation that established Tick-Borne Disease Working Group was to obtain life-saving support for patients.
• The change can help ensure that the goals and recommendations in the report capture the interest of Congress, and are actionable.

Discussion

Following Pat’s presentation, the subcommittee briefly discussed Federal resources for education and the scope of the subcommittee’s effort regarding education. Rebecca and Pat noted that the subcommittee’s focus will be largely on Lyme disease, but they will look into other tick-borne disease later because these diseases are often intertwined with Lyme disease. When asked whether or not the subcommittee would be covering overdiagnosis, Pat responded that it would not.

Members of the Working Group suggested using “Training, Education, Access to Care, and Reimbursement” as the title for the subcommittee.

Motion and Vote

Following the discussion, Sam made a motion to accept the proposed change. Pat seconded the motion. The Working Group members unanimously voted yes to changing the subcommittee’s title from “Training and Education Subcommittee” to “Training, Education, Access to Care, and Reimbursement Subcommittee.”

Decision item: The Working Group unanimously agreed to change the subcommittee’s title from “Training and Education Subcommittee” to “Training, Education, Access to Care, and Reimbursement Subcommittee.”

Discussion of Public Comment Subcommittee

Leigh Ann began the discussion of the Public Comment Subcommittee by pointing out the importance of incorporating both public and expert perspectives in the Working Group’s activities and recommendations. She explained that the Public Comment Subcommittee was formed at the Tick-Borne Disease Working Group Meeting 7 on July 24, 2018, and that, since its inception, the subcommittee has met monthly. To date, she added, the Working Group has reviewed the nearly 1000 written comments received at its [email protected] address.

Leigh Ann shared that membership of the previous members of the Public Comment Subcommittee has expired, and new volunteers are welcome to join the subcommittee to help review the public comments. So far, she added, the three Co-Chairs of the Alpha-Gal Subcommittee have reviewed all the public comments related to their topic areas and are working to incorporate them into their subcommittee report. Leigh Ann asked if anyone else from the Working Group would like to monitor and review the comments.

In response to a question from a Working Group member, Leigh Ann clarified that due to the large volume of emails received, the subcommittee does not reply to the emails; however, the subcommittee reviews all the comments received and will share the comments with other subcommittees based on the specific topics brought up by the public commenters.

Motion and Vote

Pat made a motion to approve the membership of the current three volunteers (Leigh Ann, Scott, and Angel). David seconded. The Working Group members unanimously voted yes.

Decision item: The Working Group unanimously agreed to accept Leigh Ann, Scott, and Angel as new members of the Public Comment Subcommittee.

Topic Development Brief Update

Jim introduced the session on Topic Development Briefs by explaining that, according to the 21^st Century Cures Act, one of the responsibilities of the Tick-Borne Disease Working Group is to review ongoing research and resulting advances, review Federal epidemiological and research efforts, and identify research gaps. To conduct those activities, he noted, the Working Group has compiled technical briefs that provide information about the current status of research related to three specific questions:

1. Considering tick biology, ecology, and control, what are the causes for the increased number of tick-borne disease cases in the United States?
2. What are the current diagnostic tests available for tick-borne diseases, and what is the state of the tests?
3. What are the causes of persistent symptoms of Lyme disease in the United States and globally?

Jim then introduced Selena Gonzalez, MPH and Christina Li, MPH, support contractors to the Office of Infectious Disease and HIV/AIDS Policy, HHS. Selena described the methods for developing the topic briefs and outlined the findings and conclusions made by the ad hoc committees (see Appendix 2 for ad hoc committee member names).

Methods

In the presentation of each topic development brief, Selena named the members of the ad hoc committees that were formed to help prepare the briefs and explained how they met to conduct their work. She also clarified that none of the briefs is the result of a systematic literature review or exhaustive review of all literature available on the questions posed. However, she elaborated, there were parameters set in each search to ensure the results were not biased and to ensure the searches were complete within the necessary time frame.

Selena explained that each literature search was conducted using the EBSCOhost research platform and government websites. She noted that keywords and exclusion criteria were derived from the criteria set forth in the PICOTS (Patient, Interventions/Indicators, Comparators, Outcomes, Timing, Setting). She then outlined other article exclusions, as follows.

• The full article was missing or there was not enough information in the abstract.
• The article was not from a peer-reviewed scholarly journal.
• The article was not relevant to the topic area.

Topic Brief 1: Causes of Increased Tick-Borne Diseases

Key Question, Guiding Questions, and PICOTS

For the topic development brief related to causes of increased tick-borne disease in the United States, Selena reiterated the key question and presented the guiding questions and PICOTS, as follows.

Key Question: Considering tick biology, ecology, and control, what are the causes for the increased number of tick-borne disease cases in the United States?

Guiding Questions:

1. Is the problem with ticks and tick-borne diseases particular to the United States or is it a global issue?
2. If it is a global problem, what are the particular drivers (for example, climate variability, environmental change, host and vector population increases, and range expansion) for the problem with ticks and tick-borne diseases in the United States during the past 50 years?
3. What are the challenges for implementation research on integrated tick management focused on controlling host and vector populations to decrease the risk of tick-borne disease transmission?

Population: People diagnosed with tick-borne diseases in the United States and globally

Interventions/Indicators: Understanding how climate variability, environmental change, host and vector population increases, and range expansion increase the risk of tick-borne disease transmission so we can adapt interventions

Comparators: Compare findings from interventions/indicators to each other

Outcomes: Identifiable causes for an increase in tick-borne diseases to adapt integrated tick-management interventions targeting the vector-host-pathogen interface by disrupting vulnerabilities in the biology and ecology of ticks

Timing: Past 50 years (1968–2018)

Setting: Geographic areas with increased risk of tick-borne disease transmission in the United States

Literature Assessment

After presenting the preliminary search criteria, Selena outlined the following key themes that were identified through the literature assessment.

The effect of climate on tick biology and ecology. Selena higlighted a 2017 study by Ginsberg and others that suggests the increased number of cases of Lyme disease in the northeastern and upper midwestern regions of the United States, compared with the southern states, may be related to the effects of temperature and humidity on tick behavior. According to the study, she noted, Ixodes scapularis stayed below the leaf litter surface in warmer, dryer areas of the southern U.S. and on top of the leaf litter surface in the cooler, more humid regions.

The interaction of climatic and environmental factors. Selena described a 2014 study by Jore and others that examined the interaction of climatic and environmental factors on the geographic range of Ixodes ricinus in southern Norway. The findings, she elaborated, were that—between 1978 and 2008—the geographic range expanded based on a number of complex factors including large changes in ground surface temperature, duration of snow cover, spring precipitation, an abundance of deer and farm animals, and changes in land use resulting in bush encroachment of open fields.

Variation in host availability. The Jore study, Selena noted, suggests that changes in host availability may play a role in the increased incidence of tick-borne diseases. However, she added, results of a study on Ixodes ricinus in Eastern Russia between 1977 and 2011 seem to downplay the role of host availability. The study, she explained, observed long-term growth in tick populations but little change in the number of vertebrates that ticks feed on. Moreover, Selena added, a 2014 study by Gleim and others found no relation between host abundance and tick abundance in the southern U.S.

Increase in tick abundance. Selena explained that many studies, however, predict ticks to become more abundant with continued climate change. For instance, a study by Ogden and others found that temperatures from 1971 through 2010 boosted the reproduction capacity of Ixodes scapularis. Conversely, she noted, other studies have shown just the opposite for Ixodes ricinus in Switzerland and recommend further studies to assess the role of microhabitats on tick population density.

Changes in the geographic distribution of ticks. Selena stated that studies also show changes in the geographic distribution of ticks. As an example, she referenced a study by Cheng and others, which determined that between 1979 and 2013, the range of sustainable tick habitat in Ontario expanded as a result of climate change. The authors of the study, Selena explained, predict that climate change will continue to cause shifts in the geographic distribution of ticks and the areas where tick-borne diseases are endemic.

Changes in the prevalence of pathogens in tick populations. Selena indicated that many of the studies note the increase in tick populations, but do not necessarily assess the prevalence of pathogens in tick species. Such findings, she added, suggest a need for heightened surveillance to identify the factors that increase or decrease the prevalence of tick-borne pathogens and to determine how changes in pathogen prevalence relate to changes in tick abundance and tick distribution.

Selena emphasized that, while the assessment identified the abovementioned key themes, perhaps the most glaring theme was that most of the studies were inconclusive and called for additional research.

Feasibility and Potential Impact of a Systematic Literature Review

Selena ended her presentation of the first topic development brief with the following conclusions about the feasibility and potential impact of a systematic literature review on the causes of increased tick-borne disease.

Appropriateness and Importance: This topic is both appropriate and important.

Desirability of a New Review/Duplication: A new review would not be duplicative of an existing product. No systematic review directly related to the scope of the question was found.

Impact of a New Evidence Review: A new systematic review may prove useful in the development of public health strategies to mitigate the impact of the growing threat of tick-borne diseases.

Feasibility of New Evidence Review: A new systematic literature review is likely feasible with some modifications to the selection criteria.

Selena explained that there are many studies investigating the potential causes of the increase in tick populations and tick-borne diseases; however, the ad hoc committee support team found little publications on the targeted management of host and vector populations. She noted that a focused review on the strategies to manage populations of tick species that cause disease among livestock might provide information that is applicable to human health.

Discussion

When asked about the lack of mention of vertebrate reservoir hosts and Amblyomma americanum, Selena explained that the ad hoc committee and support team did not find many peer-reviewed publications on those topics, but that such publications may be found in a systematic literature review. Jim then clarified that, due to limited resources, the topic development briefs are limited in scope.

One member asked if there were any longitudinal studies on the changing incidence of various pathogens in ticks, to which Selena referred to some of the studies she mentioned in her presentation on the changing geographic distribution of ticks. Many of those studies, she noted, looked back over a period of 20 years or more. She also pointed out that studies of geographic distribution took place more often in Europe than in the United States.

Another member suggested that, given how few studies there are—many of which are contradictory, the Working Group should recommend that Congress fund field studies on tick biology. To this, one member agreed and then highlighted some of the challenges of identifying the subtleties and differences that exist in different biological systems.

When asked for clarification on studies that were inconclusive, Selena responded that, for most of the studies assessed, the researchers stated that their results were inconclusive, and they all called for more research.

Topic Brief 2: Diagnostic Tests for Tick-Borne Diseases

Key Question, Guiding Questions, and PICOTS

For the topic development brief related to current diagnostic tests available for tick-borne diseases in the United States, Selena reiterated the key question and presented the PICOTS, as follows.

Key Question: What are the current diagnostic tests available for tick-borne diseases, and what is the state of the tests?

Guiding Questions:

1. What are the current and future diagnostic tests/assays for tick-borne diseases?
2. What is the state of the science for diagnostic tests, including direct diagnostic tests (antigen, DNA, RNA), for tick-borne diseases?
3. What are the technological challenges to the utilization and development of diagnostic tests?
   • Utilization: Identify key challenges/gaps with the current diagnostic tests/assays utilized for tick-borne diseases (accuracy, conflicting tests, other).
   • Technical: What are the biggest challenges when developing new diagnostic tests?
4. What is the current range of clinical and economic diagnostic test practices for tick-borne disease diagnosis and treatment?

Population: People at risk for or diagnosed with tick-borne diseases

Interventions/Indicators: All diagnostic tests available for tick-borne diseases; most utilized diagnostic tests available for tick-borne diseases

Comparators: Compare findings from interventions/indicators

Outcomes: A catalogue of the current state of all diagnostic tests available for tick-borne diseases

Timing: Last 20 years (1998-2019)

Setting: Not applicable

Literature Assessment

After presenting the preliminary search criteria, Selena described the seriousness of tick-borne diseases and stressed the importance of accurate and rapid diagnosis, followed by prompt treatment, in order to decrease the severity and duration of illness and, in some cases, prevent death. She added that various tests for tick-borne infections are available; however, each test has performance issues that limit their usability and affect interpretation.

Selena went on to describe the following information gathered through the literature assessment about diagnostic testing for tick-borne diseases.

Limitations of diagnostic tests available for Lyme disease. Selena described a systematic literature review conducted by Waddel and others in 2016 that reviewed evidence on the accuracy of tests and testing regimens used to diagnose Lyme disease in North America. The review, she explained, provided information about the expected sensitivities and specificities of the tests available and concluded that clinicians should base their diagnoses on the presence of signs and symptoms that are typical for each stage of illness, rather than rely entirely on imperfect serologic test protocols. Selena also highlighted a reference manual published by CDC that lists the diagnostic tests available for most, but not all, tick-borne diseases. She added that the reference manual also details the limitations of these diagnostic tests.

Challenges hindering diagnosis of other tick-borne diseases. Selena outlined some of the many challenges that hinder the accurate and timely diagnosis of tick-borne infections. Clinicians, she stated, may not always know when to test for a specific tick-borne disease, because 1) the patient’s symptoms may resemble those seen with other infections; 2) the clinician may be unaware that tick-borne diseases are present in the area where a patient lives or has traveled; and 3) the patient may not recall being bitten by a tick. Moreover, she added, according to CDC, clinical manifestations may not become apparent until several weeks or months after infection with a tick-borne pathogen; and in the case of alpha-gal allergy, symptoms may not occur after every exposure to products containing the allergen that causes illness.

Ongoing and future efforts to overcome diagnostic challenges. In describing ongoing and future efforts to overcome the obstacles to diagnosis, Selena explained that in July, 2019, the Food and Drug Administration (FDA) cleared new indications for four tests that can be used to diagnose Lyme disease. Accordingly, she added, CDC’s Lyme disease testing algorithm now allows for the use of an enzyme immunoassay (EIA) instead of a western blot in the second step of the two-step process. She then described the partnership between NIH’s National Institute of Allergy and Infectious Diseases (NIAID) and CDC to support various research projects aiming at improving Lyme disease diagnostics, a number of which have focused on the potential applications of polymerase chain reaction assays (PCR) to help detect tick-borne infections. Finally, Selena noted that a 2019 study by Hansman and others suggests that a combination of PCR and serology should be used to diagnose anaplasmosis, and that other studies are identifying methods that may be useful in diagnosing other tick-borne diseases.

Feasibility and Potential Impact of a Systematic Literature Review

Selena ended her presentation of the second topic development brief with the following conclusions about the feasibility and potential impact of a systematic literature review on diagnostic tests for tick-borne diseases.

Appropriateness and Importance: This topic is both appropriate and important.

Desirability of a New Review/Duplication: A new systematic review would be partially duplicative of an existing product.

Impact of a New Evidence Review: The impact of a new systematic literature review is likely to be low.

Feasibility of New Evidence Review: A new systematic literature review is not feasible at this time.

Selena explained that, although the development of diagnostic tests for tick-borne diseases is important and should be monitored for new developments, the ad hoc committee and support team determined that a new systematic literature review would be partially duplicative and not feasible. She noted that there is a limited amount of original research with the results for diagnostic tests that are in development or are being tested in clinical trials; and they found no literature that addresses the current range of clinical and economic diagnostic test practices for tick-borne disease diagnosis. However, she emphasized, understanding the economic impact could be a useful tool in making an economic justification for the need of accurate diagnostic testing for tick-borne diseases; additional research is, therefore, needed.

Discussion

One member asked Selena to elaborate on the discovery practices used to address the question about current clinical and economic practices relative to diagnostic testing. Selena replied that the ad hoc committee and support team did not find any articles related to that topic and that, in order to understand economic impact, more research is needed.

When asked about real-world practices around diagnostic testing and the impact of those practices on patients, Selena stated that they did not find qualitative data on that topic.

Another member asked whether there would be additional information in the topic development brief about clinicians’ lack of awareness of tests for other tick-borne diseases. Selena replied yes and clarified that the brief references clinicians in different geographic regions who may not be aware of diagnostics for Lyme disease and tick-borne diseases. Publications supporting the findings and conclusions, she said, will be referenced in the written brief to the Working Group.

Topic Brief 3: Persistent Symptoms of Lyme Disease

Key Question, Guiding Questions, and PICOTS

For the topic development brief related to causes of persistent symptoms in patients with Lyme disease, Selena reiterated the key question and presented the PICOTS, as follows.

Key Question: What are the causes of persistent symptoms of Lyme disease in the United States and globally?

Guiding Questions:

1. What is the evidence for persisting symptoms of Lyme disease in treated and untreated patients?
2. What is/are the cause(s) of persistent symptoms? (persisting infection, inadequate treatment, autoimmunity, other potential reasons, or a combination of causes?)
3. What is the epidemiology of persisting symptoms of Lyme disease?

Population: People diagnosed with Lyme disease exhibiting persistent symptoms

Interventions/Indicators: Adequate and timely treatment, autoimmune responses, other causes

Comparators: Compare findings from interventions/indicators

Outcomes: Identifiable causes of persistent Lyme disease

Timing: Last 20 years (1998-2019)

Setting: Not applicable

Literature Assessment

After presenting the preliminary search criteria, Selena explained that patients who have been diagnosed with Lyme disease are prescribed antibiotics to eliminate the causative pathogens and restore health; however, in many cases, symptoms of Lyme disease persist despite treatment. She gave examples of persistent symptoms, including musculoskeletal or radicular pain, paresthesia, dysesthesia with persistent fatigue, and neurocognitive impairment.

Selena acknowledged that the reasons for persistent symptoms of Lyme disease remain up for debate. She noted that the literature review identified the following proposed causes.

• Inadequate treatment
• Genomic differences among subspecies of B. burgdorferi
• Long-term persistence of the B. burgdorferi spirochete
• The presence of one or more co-infections
• The immune response to infection with B. burgdorferi
• Autoimmunity involvement

Selena explained that most of the studies identified in the literature assessment focus on either the immune response to infection or autoimmunity involvement. As was the case with the previous two topic development briefs, she noted, findings were inconclusive, and there is an overwhelming call for additional research.

Selena stated that many clinical trials have suggested that persistent symptoms of Lyme disease are the result of a patient’s immune response to infection. She gave the example of a 2004 study by Fleming and others, which found that levels of antibodies to the C₆ peptide remain elevated in patients with persistent symptoms of Lyme disease.

Another example Selena gave was a 2009 study by Stricker and others, which demonstrated that a lack of response to antibiotic therapy for Lyme disease is associated with a significant increase in levels of an immunologic marker known as complement split product C4a. More importantly, she added, C4a levels were elevated in patients with persistent musculoskeletal symptoms of Lyme disease, but not in patients with persistent neurologic symptoms. Such findings, she noted, suggest that the etiology of persistent symptoms of Lyme disease may depend on whether a patient’s symptoms are predominantly musculoskeletal or neurologic.

Selena explained that other studies identified regulatory T cells as the potential cause for immunosuppression in patients with chronic disease; however, all of these studies were inconclusive and determined that further research is needed.

Many investigators, Selena noted, specifically attribute Lyme arthritis (a commonly reported persistent symptom) to autoimmunity, with T lymphocytes playing a major role. She cited a study by Bolz and Weiss, which recommends further research into the pathologic potential of T cells that cross-react with human antigens, as such research would establish the importance of molecular mimicry in the development or maintenance of treatment-resistant Lyme arthritis.

Selena described a study by Chandra and others that suggests a differential immune system response occurs in patients who continue to experience symptoms of Lyme disease despite treatment. The investigators, she explained, used immunoblotting and immunohistochemistry to analyze serum samples from patients with persistent symptoms of Lyme disease, asymptomatic individuals who had been successfully treated for Lyme disease at least 2 years earlier, patients with systemic lupus, and healthy individuals as controls. She noted that the levels of antibodies to neural proteins were heightened in approximately half of the patients with persistent symptoms of Lyme disease. Moreover, she added, the heightened antibody response level in patients with persistent symptoms was statistically similar to that seen in patients with systemic lupus, a multisystem autoimmune disease.

Selena stated that other studies identified a possible link between susceptibility to persistent infection and the presence of organ-specific autoimmune diseases.

Selena highlighted the need for more research in order to improve outcomes for patients with Lyme disease and decrease the burdens associated with ongoing illness.

Feasibility and Potential Impact of a Systematic Literature Review

Selena ended her presentation of the third topic development brief with the following conclusions about the feasibility and potential impact of a systematic literature review on the persistent symptoms of Lyme disease.

Appropriateness and Importance: This topic is both appropriate and important.

Desirability of a New Review/Duplication: A new review would not be duplicative. No systematic review directly related to the scope of the question was found.

Impact of a New Evidence Review: The impact of a new systematic literature review is likely to be low.

Feasibility of New Evidence Review: A new systematic literature review will have a low impact, but is feasible at this time and may provide some potential direction for future research studies.

Selena added that there are no nationally mandated surveillance data to illustrate the extent of this public health issue, but cohort studies have shown anywhere between 10% and 40% of patients with Lyme disease continue to have persistent symptoms post-treatment. This rough statistic, she concluded, highlights the lack of certainty about the scope of the issue and demonstrates the need for more research.

Selena reiterated that most of the studies identified in the literature assessment focus on either the immune response to infection or autoimmunity involvement; therefore, it may be that additional search terms are needed during a systematic literature review, or that there is a lack of research examining the other potential causes of persistent symptoms of Lyme disease.

Discussion

Referencing the studies that involved a diagnosis of Lyme disease, one member asked if the diagnoses had been made because of persistent symptoms or if the diagnoses preceded persistent symptoms. Selena responded that most of the studies looked at patients who had received a previous diagnosis and been treated. When asked if anyone assessed the validity of those diagnoses, Selena stated that she did not recall from the papers.

One member suggested adding antibiotic tolerance as a possible explanation for persistent symptoms.

In a final discussion of all three topic development briefs, one member asked for clarification on what the ad hoc committees and support team recommended. Selena stated that there is enough literature to do a systematic literature review on the first and third topics; however, she added, most of the available research is inconclusive, and more research is needed on all three topics. She noted that for the topic of diagnostics, there were already two reviews in existence; therefore, a systematic review would be duplicative. In addition, she stated that there was no available literature for the guiding questions on diagnostics, and therefore, a systematic literature review on that topic would not be feasible.

The key takeaway, Selena concluded, is that more research is needed in all three areas. When asked whether or not she and the ad hoc committees were able to identify key themes or topics where more research is needed, Selena responded that essentially all of the findings in the publications reviewed were described as preliminary; therefore, research is needed in all areas.

Public Comments

Eight members of the public provided comments to the Working Group.

Laura Hovind: Laura, co-founder of TRUETHCURES, expressed frustration over a number of issues related to tick-borne disease, including the accuracy of information on CDC’s website and the development of a human vaccine. She noted that in her view, OspA would not work as a vaccine, and she questioned the qualification of some Working Group members.

Dorothy Leland: Dorothy, vice president of LymeDisease.org, protested the transparency of HHS and the selection process of the Working Group members. She complained that patients and advocates are not well represented, and that the public did not have adequate time to review and provide input on the membership of the Working Group and the Subcommittees. She noted that patients and treating physicians should be well represented in the subcommittees, and that the public should be given enough time to provide comments.

Jennifer Platt: Jennifer, co-founder of Tick-Borne Conditions United, shared three patient stories associated with Rocky Mountain Spotted fever in different states. She highlighted the devastating consequences caused by the lack of awareness of the disease and lack of knowledge in appropriate treatment with doxycycline. She emphasized the importance of information sharing.

Lorraine Johnson: Lorraine, chief executive officer of LymDisease.org, provided comments on behalf of patient advocates. She raised concerns over the composition of the Working Group, and she pointed out that patients and physicians are not adequately represented. She noted that compared to last year, this time there is only one member whom she considered a true patient representative, and that many members of the Working Group are academic researchers whose expertise is not in Lyme disease. She also pointed out that the Working Group does not have representatives from the International Lyme and Associated Disease Society (ILADS), which, she said, treats the majority of the patients. She noted that ILADS representatives should be added to the group.

Charlotte Meyer: An alpha-gal allergy patient in Maryland, Charlotte expressed concern about the increasing number of alpha-gal allergy diagnoses in her state, the lack of information available for patients in general, and the lack of support groups in her area. She described the intensity of her reactions to alpha-gal, as well as her increasing sensitivity to multiple triggers. She asked the Working Group to consider public awareness campaigns on tick bite prevention and highlighted the importance of raising awareness in the pharmaceutical, medical, dental, and emergency medical sectors about alpha-gal allergy and unintended exposure. Finally, she urged the Working Group make a recommendation for research funding.

Deborah Olsen: On behalf of the alpha-gal allergy community, Deborah spoke about the importance of recognizing that the allergic reaction to alpha-gal can be provoked by inhalation of particulate matter. She stated that this is especially important in schools and workplaces where there is a lack of awareness about alpha-gal allergy. She recommended updating the ICD-11 codes to reflect all alpha-gal allergy symptoms, including particulate inhalant allergy and occupational inhalant allergy. She also suggested requiring testing for all tick-borne diseases and conditions when a patient is suspected of having even just one of them. Finally, she urged the Working Group to continue to support proper labeling of all mammal-derived ingredients.

Phyllis Mervine: Phyllis, founder and president of LymeDisease.org, provided comments on behalf of patient advocacy groups. She expressed concern about the Working Group membership and referenced a petition in which patients have expressed the same concern. She outlined in detail why she and the people she represents have complaints about certain members of the Working Group.

Allison Caruana: President of the Mayday Project, Allison expressed concern about the classification of Lyme disease as a borrelial infection. She discussed the complex nature of the infection and urged further examination of the existing science, highlighting the need for transparency during this process. She stated that bringing these issues to light would help existing patients and prevent future suffering.

Leigh Ann thanked the public commenters for their contributions.

Summary of the Morning’s Discussion

DFO Jim Berger began the afternoon session with roll call, which confirmed that there was a quorum. Leigh Ann summarized the morning’s discussions, including decisions the Working Group had made to change the names of two subcommittees and accept the new volunteers of the Public Comment Subcommittee.

Federal Inventory

Led by David, the Working Group discussed the Federal inventory.

David began by explaining that the Federal inventory aids the Working Group in achieving the following goals, outlined in the 21^st Century Cures Act.

• Review all efforts within HHS related to all tick-borne diseases
• Ensure interagency coordination and minimize overlap
• Identify research priorities and gaps

David identified the agencies that were included in the Working Group’s 2018 Federal inventory: CDC, NIH, FDA, Centers for Medicare and Medicaid Services (CMS), Department of Defense (DoD), and Department of Veterans Affairs (VA). He then suggested including the U.S. Department of Agriculture (USDA) in the 2020 Federal inventory.

David described the questionnaire that was used for the 2018 Federal inventory and reviewed the results, highlighting the following information.

• CDC, NIH, and DoD managed more than 1,500 tick-borne disease projects from fiscal year (FY) 2010 to 2018.
• A total of $554 million were invested in tick-borne disease-related projects, activities, and research.
• The following tally of publications resulted from the abovementioned projects, activities, and research: CDC (467), NIH (235), DoD (41), and FDA (7).

David also outlined the following needs and gaps in research identified by the 2018 Tick-Borne Disease Working Group as a result of their Federal inventory.

• Improve early and accurate diagnosis and treatment
• Strengthen national surveillance
• Understand the immunological mechanism (for example, the pathogen-host interaction) of immune protection for Lyme disease and other tick-borne diseases
• Develop new rapid and accurate laboratory tests
• Develop antibiotic combination and/or therapeutic options for treating acute and persistent illness
• Encourage the development of strategic plans for tick-borne disease Federal investments
• Dedicate funding to tick-borne diseases and evaluate related activities using performance indicators and clear metrics for success
• Characterize how tick-borne disease affects U.S. national security, military readiness, and the health and readiness of active-duty Servicemembers, Veterans, and their families

To determine what, if anything, has been done to address the abovementioned needs and gaps in research and to collect additional information for the 2020 Tick-Borne Disease Working Group Report, David proposed the following plan for the 2020 Federal inventory and asked for comments from the Working Group members.

• Update the information in the inventory since the 2018 Tick-Borne Disease Working Group Report
• Request a report on the progress toward the agencies’ strategic plans to address tick-borne diseases
• Request a report on the progress toward addressing the unmet priorities identified in the 2018 report
• Create a Tick-Borne Disease Working Group Federal Inventory Subcommittee to analyze the new Federal inventory content for use in the 2020 Report with attention to anaplasmosis, ehrlichiosis, tick-borne rickettsiae and viruses, babesiosis, alpha-gal sensitivity, as well as Lyme borreliosis and other borrelioses.

Discussion

One member asked why the results of the 2018 Federal inventory were not posted on the Tick-Borne Disease Working Group website, to which Jim replied that the vast amount of content made it difficult to do. However, he added, the support staff would look into accommodating the request.

Members asked for clarification about the proposed Federal Inventory Subcommittee’s membership, timeline, responsibilities, and expectations for adapting the 2018 Federal inventory questionnaire to gain updates and new information. David explained that his primary focus is to request updates on progress made by the agencies, and that the Working Group could decide the format of the questionnaire.

To ensure compatibility and consistency between the 2018 and 2020 Federal inventories, the members agreed to use the existing questionnaire but tailor the request letters to each individual agency. The letters, they decided, would ask each agency for updates about the specific information sought by the Working Group. The members agreed and understood that—at the behest of DFO Jim Berger—the Office of HIV/AIDS and Infectious Diseases would compile these letters and have them signed by the Secretary of Health and Human Services and sent to the agencies.

Jim confirmed that the results of the new Federal inventory would be available for review in March or April, 2020, and that the proposed subcommittee would be composed exclusively of Working Group members. A few members expressed concern about potential conflicts of interest if subcommittee members representing specific agencies are responsible for reviewing the results of their own agencies. To this, everyone generally agreed that Federal members could serve in a consultatory role, but that the bulk of the assessment would be done by public members.

One member recommended changing the wording of the fourth bullet from “Create a Tick-Borne Disease Working Group Federal Inventory Subcommittee to analyze the new Federal inventory content for use in the 2020 Report with attention to anaplasmosis, ehrlichiosis, tick-borne rickettsiae and viruses, babesiosis, alpha-gal sensitivity, as well as Lyme borreliosis and other borrelioses” to “Create a Tick-Borne Disease Working Group Federal Inventory Subcommittee to analyze the new Federal inventory content for use in the 2020 Report with attention to anaplasmosis, ehrlichiosis, tick-borne rickettsiae and viruses, babesiosis, alpha-gal sensitivity, and Lyme borreliosis and other borrelioses.”

Another member agreed and recommended a second change in the wording, from ““Create a Tick-Borne Disease Working Group Federal Inventory Subcommittee to analyze the new Federal inventory content for use in the 2020 Report with attention to anaplasmosis, ehrlichiosis, tick-borne rickettsiae and viruses, babesiosis, alpha-gal sensitivity, and Lyme borreliosis and other borrelioses” to “Create a Tick-Borne Disease Working Group Federal Inventory Subcommittee to analyze the new Federal inventory content for use in the 2020 Report with attention to Lyme borreliosis and other borrelioses, anaplasmosis, ehrlichiosis, tick-borne rickettsiae and viruses, babesiosis, and alpha-gal sensitivity.”

Motion and Vote

Pat made a motion to create a Tick-Borne Disease Working Group Federal Inventory Subcommittee to analyze the new Federal inventory for use in the 2020 Report with attention to Lyme borreliosis and other borrelioses, anaplasmosis, ehrlichiosis, tickborne rickettsiae and viruses, babesiosis, and alpha-gal sensitivity. Sam seconded the motion. The Working Group unanimously voted in favor of the creation of the new Federal Inventory Subcommittee.

Follow-up Discussion

Following the vote, Ben Beard (CDC) and 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, volunteered to serve in consultatory roles. Public members Pat Smith and David Walker volunteered to serve on the subcommittee, as well.

Discussion of Next Two In-Person Meetings

Jim provided an update on the dates and locations for the Tick-Borne Disease Working Group’s next two in-person meetings. He stated Meeting 11 would take place on January 28 and 29, 2020, in Washington, DC, the exact location of which is to be determined. The meeting focus, he added, will be for the subcommittees to present their reports to the Working Group. Meeting 12, he continued, would be held on March 3 and 4, 2020, at the American College of Physicians in Philadelphia. The purpose of the meeting, he stated, will be for the Working Group to discuss and vote on the content of their 2020 Report to Congress and the HHS Secretary.

Summary of Decisions Made

Leigh Ann summarized the decisions that had been made during the meeting, including the following voting results.

• The Working Group unanimously agreed to change the title of “Babesiosis and Tick-Borne Viruses Subcommittee” to “Babesiosis and Tick-Borne Pathogens Subcommittee.”
• The Working Group unanimously agreed to change the title of “Training and Education Subcommittee” to “Training, Education, Access to Care, and Reimbursement Subcommittee.”
• The Working Group unanimously agreed to accept Leigh Ann, Scott, and Angel as new members of the Public Comment Subcommittee.
• The Working Group unanimously agreed to the creation of the new Federal Inventory Subcommittee.

Next Steps

Leigh Ann reviewed the upcoming milestones and deliverables for the subcommittees, highlighting the swift pace that will be required in order to have their final subcommittee reports ready for the Working Group on January 10, 2020. Two members expressed concern about the timeline; however, it was made clear that the dates are fixed in order to allow time for all phases of the process. Leigh Ann and others also responded to a few other logistical questions about the subcommittee report preparation.

Closing Remarks

David commented that the Working Group had a productive discussion, and the subcommittees have made great progress. He encouraged the subcommittees to keep the momentum going, and he anticipated that the Working Group, with the subcommittees’ support, will make a difference.

Leigh Ann expressed her gratitude for the subcommittees’ hard work. She thanked the public for attending the meeting, and the HHS team for providing support. She encouraged the public to continue providing input.

Adjournment

The meeting was adjourned at 3:05 pm.

Appendix 1: TBDWG Members and HHS Support Staff

TBDWG Members

Co-Chair
Leigh Ann Soltysiak, MS, Owner, Principal, Silverleaf Consulting, LLC; Adjunct Professor, Stevens Institute of Technology, Entrepreneurship Thinking

Co-Chair
David Hughes Walker, MD, Professor, Department of Pathology, the Carmage and Martha Walls Distinguished University Chair in Tropical Diseases; Executive Director, UTMB Center for Biodefense and Emerging Infectious Diseases

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

Scott Palmer Commins, BS, MD, PhD, Associate Professor of Medicine & Pediatrics
University of North Carolina; Member, UNC Food Allergy Initiative, Thurston Research Center

Angel M. Davey, PhD, Program Manager, Tick-Borne Disease Research Program, Congressionally Directed Medical Research Programs, U.S. Department of Defense

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 - Samuel (Sam) S. 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, U.S. Department of Health and Human Services (Alternate present)

Sam T. Donta, MD, Professor of Medicine (retired); Consultant, Infectious Diseases

Captain Estella Jones, DVM, Deputy Director, Office of Counterterrorism and Emerging Threats, 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 (Alternate present)

Kevin R. Macaluso, PhD, MS, Locke Distinguished Chair, Chair of Microbiology and Immunology, College of Medicine, University of South Alabama

Adalberto (Beto) Pérez de León, MS, PhD, Director, Knipling-Bushland U.S. Livestock Insects Research Laboratory, United States Department of Agriculture—Agricultural Research Service

Eugene David Shapiro, MD, Professor of Pediatrics, Epidemiology, and Investigative Medicine, Yale University School of Medicine; Vice Chair for Research, Department of Pediatrics; Co-Director of Education, Yale Center for Clinical Investigation; Deputy Director, Yale PhD Program in Investigative Medicine

Patricia V. Smith, President, Lyme Disease Association, Inc.

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 (Absent)

HHS Support Staff

James (Jim) Berger, MS, MT (ASCP), SBB, Designated Federal Officer, Tick-Borne Disease Working Group 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

Kaye Hayes, MPA, Alternate Designated Federal Officer, Tick-Borne Disease Working Group, Executive Director, Presidential Advisory Council on HIV/AIDS, Principal 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

Nicole Greene, Senior Public Health Advisor, 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, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services

Debbie Seem, RN, MPH, Public Health 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

Allison Petkoff, ORISE Fellow, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services

Appendix 2: Subcommittees and Topic Development Brief Ad hoc Committees

Alpha-Gal Subcommittee

Co-Chairs

Scott Palmer Commins, BS, MD, PhD, Associate Professor of Medicine & Pediatrics
University of North Carolina; Member, UNC Food Allergy Initiative, Thurston Research Center

Angel M. Davey, PhD, Program Manager, Tick-Borne Disease Research Program, Congressionally Directed Medical Research Programs, U.S. Department of Defense

Leigh Ann Soltysiak, MS, Owner, Principal, Silverleaf Consulting, LLC; Adjunct Professor, Stevens Institute of Technology, Entrepreneurship Thinking

Members

Charles Apperson, PhD, Professor Emeritus, Arthropod Vector Biology and Management, Department of Entomology, NC State

Beth Carrison, AGS Patient/Advocate and Co-founder of Tick-Borne Conditions United

Shahid Karim, PhD, Professor, Arthropod Vector Biology, Tick-Borne Diseases, Functional Genomics, Biological Science, University of Southern Mississippi

Stephen M. Rich, PhD, Professor of Microbiology, Director of the Laboratory of Medical Zoology UMASS

Sarah Stuart, Alpha-gal Advocate/Patient

Babesiosis and Tick-Borne Pathogens Subcommittee

Co-Chairs

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

Eugene David Shapiro, MD, Professor of Pediatrics, Epidemiology, and Investigative Medicine, Yale University School of Medicine; Vice Chair for Research, Department of Pediatrics; Co-Director of Education, Yale Center for Clinical Investigation; Deputy Director, Yale PhD Program in Investigative Medicine

Members

Bryon Backenson, MS, New York State Department of Health Bureau of Communicable Disease Control

Alan Barbour, MD, University of California Irvine School of Medicine and School of Biological Science

Greg Ebel, PhD, Department of Microbiology Immunology and Pathology, Colorado State University

Richard I. Horowitz, MD, Hudson Valley Healing Arts Center

Anne Kjemtrup, DVM, MPVM, PhD, California Department of Public Health Division of Communicable Disease Control

Anna Schotthoefer, PhD, Marshfield Clinic Research Institute, Integrated Research and Development Laboratory

Sam R. Telford III, MS, SD, Cummings School of Veterinary Medicine at Tufts University, Department of Infectious Disease and Global Health

Monica White, President/Co-Founder, Colorado Tick-Borne Disease Awareness Association

Clinical Aspects of Lyme Disease Subcommittee

Co-Chairs

CDR Rebecca Bunnell, MPAS, PA-C, Senior Advisor, Learning and Diffusion Group, Innovation Center, Centers for Medicare and Medicaid Services

Sam T. Donta, MD, Professor of Medicine (retired); Infectious Disease Consultant, Falmouth Hospital

Members

John Aucott, MD, Director, Johns Hopkins Lyme Disease Clinical Research Center

Rex G. Carr, MD, FAAPMR, Specialist in Physical Medicine and Rehabilitation

Brian A. Fallon, MD, MPH, Professor, Clinical Psychiatry Director, Lyme & Tick-Borne Diseases Research Center, Columbia University Irving Medical Center

Elizabeth Maloney, MD, Family Physician; President, Partnership for Tick-Borne Diseases Education

Katherine Murray Leisure, MD, Infectious Disease Specialist

James K. Mingle, President & CEO, MyCareTeam

Ehrlichiosis and Anaplasmosis Subcommittee

Co-Chairs

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

David Hughes Walker, MD, Professor, Department of Pathology, the Carmage and Martha Walls Distinguished University Chair in Tropical Diseases; Executive Director, UTMB Center for Biodefense and Emerging Infectious Diseases

Members

John Branda, MD, Clinical Microbiology and Pathology, Harvard University; Massachusetts General Hospital

Stephen Clark, Retired Associated Professor Emeritus, University of Connecticut School of Medicine

J. Stephen Dumler, MD, Professor and Chair, Joint Department of Pathology, Uniformed Services University of the Health Sciences, Walter Reed National Military Medical Center, Joint Pathology Center

Harold Horowitz, MD, Professor, Department of Medicine (Infectious Diseases), Cornell University—Weill Medical College

Bobbi Pritt, MD, Professor, Vice Chair of Education, Department of Laboratory Medicine and Pathology; Director, Clinical Parasitology Laboratory; Co-Director, Vector-Borne Diseases Laboratory Services

Daniel Sexton, MD, Professor of Medicine (Infectious Diseases), Duke University School of Medicine

Gregory A. Storch, MD, Professor of Pediatrics (Infectious Diseases), Medicine, and Molecular Microbiology; Chief, Division of Pediatric Laboratory Medicine, Washington University

Pathogenesis and Physiology of Lyme Disease

Co-Chairs

Sam T. Donta, MD, Professor of Medicine (retired); Consultant, Infectious Diseases

Leith Jason States, MD, MPH, Acting Chief, Medical Officer, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services

Members

Wendy Adams, Research Grant Director, Bay Area Lyme Foundation

Troy Bankhead, PhD, Associate Professor, School of Veterinary Microbiology and Pathology, Washington State University

J. Nicole Baumgarth, DVM, PhD, Professor, Center for Comparative Medicine and Department of Pathology, Microbiology and Immunology, University of California, Davis

Monica E. Embers, PhD, Director of Vector-Borne Disease Research, Division of Immunology, Tulane National Primate Research Center

Robert Lochhead, PhD, Assistant Professor of Microbiology and Immunology, Medical College of Wisconsin

Brian Steveson, PhD, Professor, Department of Microbiology, Immunology and Molecular Genetics, University of Kentucky College of Medicine

Rickettsiosis Subcommittee

Co-Chairs

Captain Estella Jones, DVM, Deputy Director, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, U.S. Department of Health and Human Services

Commander Todd Myers, PhD, Office of the Chief Scientist, Office of Counter Terrorism and Emerging Threats, Food and Drug Administration

David Hughes Walker, MD, Professor, Department of Pathology, the Carmage and Martha Walls Distinguished University Chair in Tropical Diseases; Executive Director, UTMB Center for Biodefense and Emerging Infectious Diseases

Members

Lucas Blanton, MD, Associate Professor of Internal Medicine (Infectious Diseases), University of Texas Medical Branch at Galveston

Karen Bloch, MD, MPH, FIDSA, FACP, Associate Professor of Medicine (Infectious Diseases) and Health Policy, Vanderbilt University Medical Center

Christina M. Farris, PhD, Viral and Rickettsial Diseases Department, Naval Medical Research Center

Vance Fowler, MD, Professor of Medicine, Duke University

Tony Galbo, Father of a child who died of Rocky Mountain spotted fever

David N. Gaines, PhD, State Public Health Entomologist, Virginia Department of Health

Christopher D. Paddock, MD, MPHTM, Rickettsial Zoonoses Branch, CDC

Hayley Yaglom, MS, MPH, One Health Genomics Epidemiologist, Translational Genomics Research Institute

Tick Biology, Ecology, and Control

Co-Chairs

Adalberto (Beto) Pérez de León, MS, PhD, Director, Knipling-Bushland U.S. Livestock Insects Research Laboratory, United States Department of Agriculture—Agricultural Research Service

Kevin R. Macaluso, PhD, MS, Locke Distinguished Chair, Chair of Microbiology and Immunology, College of Medicine, University of South Alabama

Members

Trey Cahill, MUrP, Public Health Analyst, Location Intelligence (GIS); Health Regulation and Licensing Administration, DC Department of Health

Neeta Pardanani Connally, PhD, MSPH, Associate Professor and Director, Tick-borne Disease Prevention Laboratory, Department of Biological and Environmental Sciences, Western Connecticut State University

Maria Diuk-Wasser, PhD, Associate Professor, Department of Ecology, Evolution and Environmental Biology, Columbia University

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

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

Howard Ginsberg, PhD, Research Ecologist and Field Station Leader of the USGS Rhode Island Field Station; Professor in Residence, University of Rhode Island

R. Michael Roe, PhD, William Neal Reynolds Distinguished Professor, Department of Entomology and Plant Pathology, North Carolina State University

Bob Sabatino, Founder and Executive Director, Lyme Society Inc.

Daniel Sonenshine, PhD, Guest Researcher, LMVR, NIAID, NIH Eminent Professor of Biological Science, Old Dominion University

Kirby C. Stafford III, PhD, Chief Entomologist/State Entomologist, Department of Entomology; Center for Vector Biology and Zoonotic Diseases, Connecticut Agricultural Experiment Station; NE Regional Center for Excellence in Vector Borne Diseases

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

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

Training, Education, Access to Care, and Reimbursement

Co-Chairs

Patricia V. Smith, President, Lyme Disease Association, Inc.

Commander Rebecca Bunnell, MPAS, PA-C, Senior Advisor, Learning and Diffusion Group, Innovation Center, Centers for Medicare and Medicaid Services

Members

Megan Dulaney, MS, Patient Representative, Senior Interagency Liaison & Policy Advisor, Henry M. Jackson Foundation for the Advancement of Military Medicine in support of DoD Health Affairs and Center for Global Health Engagement, Uniformed Services University

Doug Fearn, President, Lyme Disease Association of Southeastern Pennsylvania, Inc

Lorraine Johnson, JD, MBA, Health Care Policy Expert; CEO, LymeDisease.org

Elizabeth Maloney, MD, President, Partnership for Tick-Borne Diseases Education

Sheila M. Statlender, PhD, Clinical Psychologist, Private Practice; Chair, Massachusetts Lyme Legislative Task Force

Topic Development Brief Ad hoc Committee Members

Topic 1: Causes of Increased Tick-Borne Diseases Ad hoc Committee

Adalberto (Beto) Pérez de León, MS, PhD, Director, Knipling-Bushland U.S. Livestock Insects Research Laboratory, United States Department of Agriculture—Agricultural Research Service

Bob Sabatino, Founder and Executive Director, Lyme Society Inc.

Topic 2: Diagnostic Tests for Tick-Borne Diseases Ad hoc Committee

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

Leigh Ann Soltysiak, MS, Owner, Principal, Silverleaf Consulting, LLC; Adjunct Professor, Stevens Institute of Technology, Entrepreneurship Thinking

Topic 3: Persistent Symptoms of Lyme Disease Ad hoc Committee Members

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

Sam T. Donta, MD, Professor of Medicine (retired); Consultant, Infectious Diseases