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TBDWG February 12, 2018 - Meeting Summary

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.


John Aucott, Working Group Chair, Associate Professor, Division of Rheumatology, Johns Hopkins University School of Medicine; Director, Johns Hopkins Lyme Disease Clinical Research Center, welcomed participants to the meeting.

Recap of Public Meetings 1 and 2

John provided an overview of the first two public Tick-Borne Disease Working Group meetings and described the working group’s accomplishments since those meetings. At public meetings 1 and 2, invited speakers discussed a wide variety of topics, which demonstrated the magnitude of issues related to tick-borne diseases. The presentations covered the following topics:

  • maintaining an open, balanced interpretation of the field and literature;
  • implementing awareness and prevention campaigns;
  • advancing diagnostics;
  • understanding chronic symptoms;
  • following tick-borne disease therapies; and
  • improving surveillance and vector control.

Presentations were complemented by public comment.

During the public meetings, the working group began a discussion about the group’s vision, mission, and values. The group voted to establish six subcommittees, which include:

  • Disease Vectors, Surveillance, and Prevention;
  • Pathogenesis, Transmission, and Treatment;
  • Testing and Diagnostics;
  • Access to Care Services and Support to Patients;
  • Vaccine and Therapeutics; and
  • Other Tick-Borne Diseases and Co-Infections.

Following the meetings, the working group selected co-chairs for each subcommittee. The co-chairs then evaluated subcommittee member applicants and worked with the working group chair, co-chair, and designated federal officer (DFO) to finalize membership of the subcommittees.

Meeting Purpose and Goals

John noted that the overall purpose of the working group is to serve patients and the public. He remarked that diverse participants are essential to addressing tick-borne diseases. He briefly reviewed the objectives of public meeting 3, which were to:

  • discuss the steps and timeline for the working group’s report to Congress and the U.S. Department of Health and Human Services (HHS) Secretary;
  • review and vote on the working group’s mission statement, vision, and values;
  • hear from an invited guest about the internal HHS working group for addressing tick-borne disease;
  • learn from an invited guest about the state of Virginia’s successful collaboration model for dealing with tick-borne diseases; and
  • attend break-out sessions for subcommittees to conduct introductions, review the inventory document, and discuss priorities.

Report to Congress and the HHS Secretary

Richard (Rich) Wolitski, DFO, Director, Office of HIV/AIDS and Infectious Disease Policy, Office of the Assistant Secretary for Health, described the report that the Tick-Borne Disease Working Group is tasked with producing. The working group’s efforts will culminate in a report that describes current efforts to address tick-borne diseases, identifies gaps in this work, and makes recommendations to Congress and the HHS Secretary. The report is mandated by the 21st Century Cures Act, which established the working group and requires the group to produce a report every 2 years. The final report will be publicly available on the HHS website.  

Each subcommittee will create a report and present it to the working group. The working group will synthesize that information, in combination with information from other sources, to create the final report. To inform the report, the working group will gather information on current research and recent advancements and gather input from states, local governments, and other entities through public comment. So far, the working group has received extensive public comment through the working group email inbox.

Initially, subcommittees need to identify issues and questions that are important to address within their topic areas. From that list, subcommittees will prioritize several issues to focus on in their literature reviews. To determine priorities, each subcommittee should first evaluate the impact of each issue and the feasibility of addressing it and then select issues that the subcommittee believes will be the most beneficial to the public and those affected by tick-borne diseases.

Once the subcommittees have identified their priorities, they will be asked to focus on the evidence surrounding each issue, current efforts to address it, opportunities to improve the federal response, threats or challenges to implementing changes, and recommendations for the working group to consider presenting in the report to Congress. Additionally, subcommittees should indicate the extent to which they support or oppose current efforts.

To create their reports, subcommittees should review key studies and reports related to their priority topics. They can also invite outside experts to deliver presentations on priority topics during their meetings. Rich W. requested that subcommittee members vote on the characterization of each issue and corresponding recommendations within the subcommittee reports. He noted the potential for disagreement among subcommittee members and the importance of clearly acknowledging controversial topics within the report. The reports should indicate how many members supported or opposed each recommendation and describe the opinions of those opposed. Once the reports are complete, subcommittee members should vote to ensure members agree that the document is ready for submittal to the working group.

Subcommittee reports are due to the working group on May 4. This project is broken into milestones to help subcommittees accomplish the work in increments. Using the subcommittee reports and other information, the working group will develop an initial draft of the report to Congress by July 2018. The report will then go out for public and agency comment. The working group will incorporate public comment to resubmit a final draft to HHS and the U.S. Department of Defense (DOD) review and clearance. The final report must be posted online by December 13, 2018.

Mission, Vision, and Values

Kristen Honey, Working Group Vice Chair, PhD, PMP, Senior Policy Analyst, Office of Management and Budget, Executive Office of the President; Senior Research Scholar, Stanford University; Member, Stanford University Lyme Disease Working Group, facilitated a review of the working group’s vision statement, mission statement, and core values.

Kristen moved to accept the following vision statement for the Tick-Borne Disease Working Group:

“A nation free of tick-borne diseases where new infections are prevented and patients have access to affordable care that restores their health.”

Working group members in attendance unanimously passed the proposed statement.

Kristen noted that the mission statement was still in progress and asked for a volunteer to further refine it. Scott Cooper, Lead Officer and Senior Technical Advisor for Medicare Hospital Health and Safety Regulations, Centers for Medicare and Medicaid Services, volunteered to lead efforts to develop the mission statement and formally pass it at the next meeting.

Kristen moved to adopt the following core values:

  1. Respect: everyone is valued
  2. Innovation: shifting the paradigm, finding a better way
  3. Honesty and integrity: find the truth, tell the truth
  4. Excellence: quality, real-world evidence underlies decision-making
  5. Compassion: finding solutions to relieve suffering
  6. Collaboration: work with citizens and patients as partners
  7. Accountability: the buck stops here

All working group members in attendance voted in favor of adopting the core values.

Update from the Internal HHS Working Group

Anna Perea, Policy and Communication Lead at the Bacterial Diseases Branch Division of Vector-Borne Diseases, Centers for Disease Control and Prevention (CDC), provided an update about the HHS All Federal Working Group on Lyme and Tick-Borne Diseases. This informal group aims to foster collaboration and communication on activities and shared interests related to tick-borne diseases. Participants include HHS staff from CDC, Food and Drug Administration, National Institutes of Health, National Institutes of Allergy and Infectious Diseases, and the National Vaccine Program Office. The group holds two meetings per year. Key accomplishments include annual public webinars on issues related to tick-borne diseases and establishment of a 280-sample, well-characterized serum panel for distribution for investigators who are working on new diagnostic tests for Lyme disease. The group did not host a webinar this year due to HHS personnel involvement in the Tick-Borne Disease Working Group and other efforts, but intends to continue the webinars next year.

Example of Successful Collaboration in Virginia

Michael Farris, JD, LLM; President, CEO, and General Counsel; Alliance Defending Freedom, described a successful collaboration model that the state of Virginia uses to address tick-borne diseases. In Virginia, a 12-member task force convened to evaluate diagnosis, treatment, prevention, the impact of the diseases on children, and public education. The task force held nine hearings around the state, including five listening sessions for patients and families of those affected. Michael emphasized the importance of gathering input from patients and their families as instrumental guidance in determining how to address tick-borne diseases.

Michael shared some of his observations based on the taskforce’s findings. First, tick-borne diseases are a rapidly growing sector of illnesses, and more science is needed to understand the issue and how to address it. Tick-borne diseases are under-reported, in part due to physicians failing to follow through with reporting duties. Additionally, public awareness about these diseases needs significant expansion.

Roles and Tasks of the Subcommittees and Subcommittee Members

John described the three major tasks the working groups need to accomplish.

  1. Choose several priority issues and identify gaps and opportunities for each of those issues.
  2. Begin to conceptualize recommendations to address the gaps and opportunities.
  3. Create a report to the working group.

Rich W. further described the subcommittee responsibilities and the processes for the subcommittee meetings. The main focus of the subcommittees is to compile their reports to the working group. Subcommittees will provide evidence, identify relevant studies, document challenges and problems, and point the working group toward solutions. The subcommittees will have the discretion to determine the best approach to compiling the information they present in the reports to the working group.

Subcommittee Meetings

Subcommittees can schedule meetings according to what works best for subcommittee members and can invite speakers to present evidence and information. Subcommittee co-chairs should attempt to confirm meeting times at least 48 hours in advance, and no fewer than 24 hours in advance. Co-chairs must notify all subcommittee members about each meeting and copy the working group chair, vice chair, DFO, and alternate DFO. Writers from CommunicateHealth and Kauffman & Associates, Inc., will attend each meeting to take notes and will provide meeting summaries. Once made Section 508-compliant, the meeting summaries will be posted to the Tick-Borne Disease Working Group’s SharePoint site within 10 days following each meeting. Writers will also assist the subcommittees in developing their reports to the working group.

Public Comment

Eight attendees provided brief comments.

Comments from Julia Wagner

Julia described the need for better tracking of deaths related to tick-borne disease and a shift in the language surrounding tick-borne illnesses to emphasize the seriousness of the issue. Pennsylvania has the highest number of reported cases of tick-borne disease, and those numbers continue to increase. The majority of reported cases are among children and young adults. In recent years, the number of deaths related to tick-borne disease has increased. However, in Pennsylvania, there is no tracking system in place to monitor the number of deaths related to tick-borne diseases. Julia remarked that current language around tick-borne disease depicts the illnesses as benign and stated that the language needs to shift to acknowledge the seriousness of health risks related to Lyme disease.

Comments from Beth Carrison-van der Heide

Beth, an advocate for those affected by Alpha-Gal syndrome, shared specific concerns related to Alpha-Gal syndrome. Lone Star ticks are found in over 1,300 counties and 39 U.S. states, and CDC reports the ticks are expanding to new areas. Additionally, Alpha-Gal is known to stem from six other ticks worldwide, which puts members of the U.S. military at risk. She described several social and economic consequences of the condition, including:

  • the potential for the spread of infectious disease due to the inability to participate in many vaccinations,
  • liability and financial burdens to public schools and employees, since Alpha-Gal Syndrome is covered by the Americans with Disabilities Act, and
  • decreased acceptance in the U.S. military due to inability to receive mandated vaccinations and the risk surrounding the condition.

Beth emphasized the importance of including Alpha-Gal in the working group’s scope of work and requested the working group expand their language to specifically include Alpha-Gal.

Comments from Jennifer Burton

Jennifer B. described the gaps in care and services faced by those affected by Alpha-Gal syndrome and other tick-borne illnesses. These gaps affect patients’ quality of life and can result in improper care and medications and personal financial losses due to medical bills. These gaps include:

  • education and resources for the medical industry regarding tick-borne illnesses and their symptoms;
  • education for first responders, paramedics, and emergency room personnel, especially in anaphylactic cases;
  • education for pharmacists about the dangers of providing gelatin capsules, lactose, whey, and other mammalian products to people with Alpha-Gal Syndrome; and
  • accurate and full disclosure of all ingredients in food labeling, such as natural flavorings that contain mammalian ingredients.

Comments from Gary Sweeney

Gary shared the story of his daughter’s struggle to be accurately diagnosed with Lyme disease. He noted that Lyme disease has emerged as the top reported vector-borne disease in the United States, and it needs funding, attention, and a level of effort that match its prevalence. He presented questions about the diagnosis, treatment, and basic biology of Lyme disease, specifically related to:

  • patients and their families being told that Lyme does not exist in non-endemic areas,
  • what types of ticks are vectors for Lyme disease,
  • how spirochetes interact with the immune system,
  • current and potential approaches to testing for tick-borne diseases,
  • whether the Dearborn case definition of Lyme disease was properly vetted by diverse scientific and medical communities,
  • why patients are limited to 2 to 4 weeks of antibiotics to treat tick-borne disease,
  • treatment of persistent tick-borne infections, and
  • treatment recommendation standards used by the Infectious Diseases Society of America.

Comments from Timothy Opiela

Timothy provided comments about the impact on children with Alpha-Gal syndrome who cannot receive vaccines. These children cannot be safely vaccinated for many recommended and required vaccines, since the vaccines incorporate mammalian products or byproducts, such as gelatin. A review of vaccines deemed important by CDC shows that only 37% of the vaccines are potentially safe to administer to people with Alpha-Gal, leaving them unprotected from preventable diseases 63% of the time. Timothy shared that his daughter has Alpha-Gal syndrome. Over the past year, she had to refrain from recommended or required vaccines, including vaccines against human papillomavirus; tetanus, diphtheria, pertussis; and meningitis. As the number of people affected by Alpha-Gal increases, so do gaps in infectious disease pathways due to the number of people who are unable to be vaccinated, which poses a significant health risk to the general public. Timothy requested that the working group specifically consider Alpha-Gal in their efforts.

Comments from Jennifer Platt

Jennifer P. noted that researchers cannot track or validate the impacts of Alpha-Gal syndrome and other tick-borne conditions because these conditions have not been assigned specific International Statistical Classification of Diseases and Related Health Problems, 10th edition, (ICD-10) diagnosis codes. She stated that more complete testing approaches are needed. For example, she expressed concern about the approach of diagnosing Lyme disease based on the presence of erythema migrans. Since a Lone Star tick bite can also cause erythema migrans, this approach may lead to inaccurate diagnosis of Lyme disease. Jennifer P. thanked the working group for their decision to include Alpha-Gal syndrome and other tick-borne conditions in the report to Congress. For additional emphasis on conditions such as Alpha-Gal syndrome, Jennifer P. requested that the working group consider expanding the charter language and vision statement to reference “tick-borne diseases and conditions.”

Comments from Jena Blair

Jena stated that attempting to vaccinate against Borrelia is not a viable option, since Borrelia are relapsing fever germs and are, therefore, capable of antigenic variations. She expressed her belief that the outer surface protein A (OspA) vaccine causes immune suppression and causes a disease indistinguishable from chronic Lyme disease because OspA is a fungus-like endotoxin. She asked that the working group provide answers about the structure and function of OspA.

Comments from Kathy Nodolf

Kathy also asked that the working group state for public record the structure and function of OspA. She further stated that a falsified case definition of Lyme disease has been in use since the case definition was changed at CDC’s 1994 Dearborn Conference and that current testing approaches are nonsensical in the context of Borrelia as relapsing fever germs. Since all relapsing fever organisms are capable of antigenic variations, they can change their outer surface protein to evade the host’s immune system. She said that the only scientifically valid way to test for Borrelia infections is to test for flagellar antibodies instead of outer surface proteins and pointed to a test done by Erol Fikrig and Richard Flavell in 1991 that had 94 to 95 percent accuracy. She urged for a careful examination of the definition of Lyme disease.

Individual Subcommittee Meetings

A breakout session was offered for each of the six subcommittees. During the breakout sessions, subcommittee members introduced themselves and discussed their responsibilities, timelines, and processes. Subcommittees reflected on potential issues and questions to raise for public comment at the upcoming national town hall meeting. Subcommittees also reviewed the inventory of tick-borne disease projects and activities, which will be sent to HHS and DOD to gather information on their current efforts, funding, and gaps or opportunities related to tick-borne disease. Subcommittee members provided input on the inventory documents to ensure the categories listed under their topic areas fully and accurately represent the information they would like to gather. Additionally, several subcommittees began to identify potential focus areas for their reports to the working group. Summaries of each breakout session are included in the sections below.

Disease Vectors, Surveillance, and Prevention

Pat Smith welcomed the subcommittee members to the breakout session and facilitated introductions.

Pat Smith, Subcommittee Co-Chair
President, Lyme Disease Association

Ben Beard, Subcommittee Co-Chair
Deputy Director, Division of Vector-Borne Diseases, CDC

Jill Auerbach
Founder, Tick Research to Eliminate Diseases; Founder, Stop Ticks On People (S.T.O.P.)

Neeta Connally, PhD, MSPH
Associate Professor, Tick-borne Disease Prevention Laboratory, Western Connecticut State

Katherine Feldman, DVM, MPH
Senior Epidemiologist, MITRE

Thomas N. Mather, PhD
Professor, Center for Vector-Borne Disease; Director, Tick Encounter Resource Center

Phyllis Mervine
President, LymeDisease.org

Colonel Robin Nadolny, PhD
Medical Service Team Lead, Tick-Borne Disease Laboratory, Army Public Health Center

Alberto Perez de Leon, DVM, PhD, MS
Director, Knipling-Bushland U.S. Livestock Insects Research Laboratory, U.S. Department of Agriculture Agricultural Research Service

Daniel E. Sonenshine, PhD
Eminent Professor of Biological Science, Old Dominion University

Jean I. Tsao, PhD
Associate Professor, Departments of Fisheries and Wildlife and of Large Animal Clinical Sciences, Michigan State University

Monica M. White
President and Co-founder, Colorado Tick-Borne Disease Awareness Association, LymeDisease.org, Lyme Disease Association, Inc., Public Tick Integrated Pest Management working group, Chaffee County Health Coalition

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

Overview of Subcommittee Tasks and Processes

Pat reviewed the subcommittee’s purpose and responsibilities. The purpose of the subcommittees is to provide the working group with the information needed to develop the report to Congress. The subcommittees are responsible for completing an overview of the issues, gathering data, and identifying gaps in the federal response. In May, the subcommittees will present their findings to the working group. Interim milestones will help keep subcommittees on track to complete their reports to the working group. The first milestone involves creating a list of potential topics and identifying three to five topics to focus on in the subcommittee’s assessment.  

Review of Inventory Document

The subcommittee reviewed the inventory of tick-borne disease projects and activities and discussed whether additional categories should be added. Recommendations from subcommittee members included the following edits be made to the inventory before sharing it with HHS and DOD.

  • Inquire about the integrated tick management strategies that agencies use.
  • Distinguish between vector surveillance and surveillance of human disease, possibly by adding the words “human” and “vector” in parentheses after the category name.
  • Split the prevention category into personal prevention and environmental prevention.
  • Include training as a category or reword an existing category to specifically reference training.
  • Inquire about research and development partnerships with private industry.
  • Add emerging and reemerging tick-borne diseases as a category to gather information about ways ticks interact with various hosts and how hosts interact with various diseases in nature.

The group discussed the need to specifically list which diseases are included in the “other tick-borne diseases” category. That way, they can help ensure that responses from HHS and DOD include all tick-borne diseases. Additionally, the group discussed expanding the inventory to gather information from other federal stakeholders who work on issues related to tick-borne disease, including the U.S. Department of Agriculture, Environmental Protection Agency, and U.S. Geological Survey.

Issues for Upcoming National Town Hall Meeting

Pat asked the group to recommend issues or questions that the working group can present at the upcoming national town hall meeting to gather community input. Suggested issues included:

  • reservoir ticks;
  • environmental and personal protection;
  • funding;
  • tick research, including genomic research;
  • the community’s opinion on whether adequate prevention education is in place;
  • whether members of the public, patients, and physicians have the resources they need;
  • how current surveillance impacts access to care for patients; and
  • how the public receives information about tick range expansions and the changing risks.

Pathogenesis, Transmission, and Treatment

Wendy Adams welcomed the group and conducted roll call. She asked the subcommittee members to introduce themselves.

Wendy Adams, Subcommittee Co-Chair
Research Grant Director, Bay Area Lyme Foundation

Pat K. Coyle, MD
Neurology Professor and Vice Chair, Department of Neurology; Director, Multiple Sclerosis Comprehensive Care Center, Stony Brook University Medical Center

Sam Donta, MD
Professor of Medicine (retired); Fellow Infectious Diseases, Infectious Disease Society of America; Consultant, Infectious Diseases

Brian Fallon, MD, MPH
Professor of Clinical Psychiatry; Director, Lyme and Tick-Borne Diseases Research Center, Columbia University

Lorraine Johnson, JD, MBA
CEO, LymeDisease.org

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

Jon Skare, PhD
Professor and Associate Head, Department of Microbial Pathogenesis and Immunology, Texas A&M University

Brian Stevenson, PhD
Professor, Department of Microbiology, Immunology & Molecular Genetics, University of Kentucky College of Medicine

Overview of Subcommittee Tasks and Processes

Wendy reviewed the subcommittees’ purpose and responsibilities. Subcommittees are tasked with developing reports to the working group, which they will present to the working group in May. The working group will use this information to develop the report to Congress, which will be sent out for public comment.

Interim milestones will help keep subcommittees on track to complete their reports to the working group. The first milestone involves creating a list of potential topics and identifying three to five topics to focus on in the subcommittee’s report to the working group. This milestone is due February 23. The next milestone, due on March 9, is the background section of the report.

Today’s meeting is open to the public, but subcommittee meetings are closed meetings and their content is confidential.

Review of Inventory Document

The subcommittee reviewed the inventory of tick-borne disease projects and activities and discussed whether additional categories should be added or certain aspects of existing categories should be emphasized. Subcommittee members made the following recommendations.

  • Gather information specifically about nervous system involvement. Rather than being added as a category, this topic may need to be framed as a clarifying question in response to the completed inventory.
  • Adjust the questions on funding to gather information about each fiscal year for the past 15 to 20 years, rather than seeking cumulative funding information that covers 6 or 7 fiscal years. Inquire about the percentage of the program’s overall budget allocated to tick-borne disease issues in addition to dollar amounts.
  • Reword the question “How does your office engage the public and other stakeholders in planning activities and obtaining feedback on activities?” to gather feedback specifically on how research and communication efforts engage patients in particular, in addition to the general public.
  • Inquire about programs that study the clinical impact of co-infections.
  • Gather information on studies of chronic symptoms to ensure that post-treatment symptoms are considered in addition to acute symptoms.

Issues for the Upcoming National Town Hall Meeting

Wendy asked the group to recommend issues or questions that the working group can present at the upcoming national town hall meeting to gather community input. Suggested issues included:

  • outcomes that patients regard as important related to Lyme disease,
  • how to develop solutions and discussions that are based in scientific rigor, and
  • how to prioritize the greatest needs in the absence of perfect data or evidence.

Identification of Topics

For the upcoming milestone, Wendy explained that the subcommittee needs to create a list of issues and narrow that list down to 3 to 5 priority issues to address in the report that would be the most beneficial to patients, physicians, and other stakeholders. The group brainstormed the following issues:

  • persistence of disease and infection in untreated immuno-competent hosts;
  • possible persistence of tick-borne disease despite antibiotic treatment;
  • how Borrelia burgdorferi leaves the tick and initially infects the host;
  • what occurs in untreated patients (e.g., How is bacteria with a surface covered in antigenic proteins not cleared by the immune system?);
  • novel approaches to treatment, such as evaluating detection and blocking transmission;
  • effective treatment to restore health to patients with Lyme disease;
  • the impact of delayed diagnosis on the course of Lyme disease;
  • whether variations in immune response are based on the host or the strain;
  • bio-markers to guide treatment;
  • studies on helping patients with chronic symptoms;
  • what subset of Lyme patients, early or late, have central nervous system involvement, using sophisticated or imaging techniques to detect central nervous system inflammation or circuit disruption, and molecular techniques to look at immune inflammatory markers; and
  •  the best antibiotic regimens for neurological infection.

Testing and Diagnostics

John welcomed everyone to the breakout session and noted that Kristen will normally be the working group leader assigned to this subcommittee. However, for this meeting, he stood in for subcommittee co-chair Lise Nigrovic, who was unable to be present during the first few minutes of the meeting. John facilitated subcommittee member introductions.

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

Lise Nigrovic, Subcommittee Co-Chair
Co-Director of Population Science Center, Institutional Centers for Clinical and Translational Research; Senior Associate Physician in Medicine, Boston Children's Hospital

Roberta DeBiasi, MD, MS
Chief, Children’s National Medical Center Division of Pediatric Infectious Diseases; Director, Fetal Infectious Diseases Program; Co-Director, Congenital Zika Program at Children's National Health System

Noel Gerald, PhD
Biologist and Senior Scientific Reviewer, Office of In Vitro Diagnostics and Radiological Health, U.S. Food and Drug Administration

Deborah Hoadley, MD, MPH
Board-Certified Infectious Diseases Specialist; Director, New England Institute for Lyme Disease and Tick-Borne Illnesses

Maliha Ilias, PhD
Program Officer, Lyme Disease Research Bacteriology and Mycology Branch, National Institute of Infectious Diseases, National Institutes of Health

David Roth, JD
Retired senior managing director of a private equity firm (Blackstone)

Steven Schutzer, MD
Physician-Scientist, Rutgers, New Jersey Medical School

Overview of Subcommittee Tasks and Processes

The group discussed the confidentiality considerations of the working group and the subcommittees. While the working group meetings are open to the public and subject to the Federal Advisory Committee Act, the discussions and work done during the subcommittee meetings are confidential to allow for uninhibited discussion of sensitive topics. Subcommittee members are welcome to discuss these issues with members of other subcommittees where there is overlap.

Review of Inventory Document

The subcommittee reviewed the inventory of tick-borne disease projects and activities and discussed whether additional categories should be added or certain aspects of existing categories should be emphasized. Subcommittee members provided the following recommendations.

  • Specifically inquire about regulatory efforts.
  • Wherever tick-borne diseases are referenced, add “and associated conditions.”

The subcommittee considered how many years of grant funding information to request. Because of the enormous amount of information available, they discussed that 1 to 2 years of information would be appropriate.

Identification of Topics

John explained that the subcommittee needs to create a list of issues and narrow that list down to 3 to 5 priority issues to address in the report that would be the most beneficial to patients, physicians, and other stakeholders. The group discussed the following issues:

  • improved accuracy of testing,
  • limitations of current diagnostic approaches, and
  • clinician and patient education.

The group discussed the need to ensure consistent language throughout the subcommittee reports by defining accuracy or other terms. Developing a glossary of terms could provide a resource for all subcommittees. The subcommittee also considered the possibility of breaking the subcommittee into smaller groups who can focus on each priority identified.

Access to Care and Support to Patients

Karen Vanderhoof-Forschner welcomed the attendees to the breakout session. She invited the subcommittee members to conduct introductions.

Karen Vanderhoof-Forschner, Subcommittee Co-Chair

Scott “Coop” Cooper, Subcommittee Co-Chair
Lead Officer and Senior Technical Advisor for Medicare Hospital Health and Safety Regulations, Centers for Medicare and Medicaid Services

Anna Frost, PhD
The Institute for Functional Medicine

Holiday Goodreau
President and Executive Director, The LiveLyme Foundation

Enid Haller, LCSW, PhD
Executive Director, Lyme Center of Martha's Vineyard; Martha's Vineyard Lyme Support Group

Paula Jackson Jones,
President & Co-Founder, Midcoast Lyme Disease Support & Education

Colonel Nicole Malachowski
Retired, U.S. Air Force

Leonard Schuchman, DO, MPH, FAAFP,
Lyme Disease Foundation

Sheila Statlender, PhD
Clinical Psychologist, Private Practice; Member, American Psychological Association, International Lyme and Associated Diseases Society, Massachusetts Psychological Association, and National Register of Health Providers in Psychology

Kathleen Steele, LCSW

Review of Inventory Document

The subcommittee reviewed the inventory of tick-borne disease projects and activities and discussed whether additional categories should be added or certain aspects of existing categories should be emphasized. Subcommittee members made the following recommendations.

  • Ask for more information about releases of ticks as biological warfare research, including types of ticks that were released and where they were spread.
  • Inquire about medical care and protocols for patients seeking diagnosis and treatment.
  • Where tick-borne diseases are referenced, add, “tick paralysis, Bartonella, Apha-Gal, Borrelia hermsii, and Borrelia mayonii” to ensure information is gathered on all tick-borne illnesses.
  • Request information about efforts related to co-infections.

The subcommittee also discussed expanding the inventory to gather information from other federal stakeholders who work on issues related to tick-borne disease, including the Department of Veterans Affairs (VA), Bureau of Indian Affairs, and Centers for Medicare & Medicaid Services.

Identification of Topics

The subcommittee considered several issues that could be included in the list of topics due as part of the first milestone of the subcommittee report. Topics identified included:

  • challenges related to the use of the CDC case definitions by medical insurance companies as a diagnostic guide for Lyme disease and
  • the use of clinical criteria, like the tick triad, for diagnosis, as opposed to lab tests.

Vaccine and Therapeutics

Dennis Dixon welcomed the subcommittee members to the breakout session and facilitated introductions.

Dennis Dixon, Subcommittee Co-Chair
Chief, Bacteriology and Mycology Branch, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, HHS

Felipe C. Cabello, MD
Professor of Microbiology and Immunology, New York Medical College

Monica E. Embers, PhD
Assistant Professor (Tenure-track); Director, Vector-Borne Diseases Core, Division of Bacteriology and Parasitology, Tulane National Primate Research Center, Tulane University School of Medicine

Maria Gomes-Solecki, DVM
Associate Professor, Department of Microbiology, Immunology and Biochemistry, University of Tennessee Health Science Center

Utpal Pal, PhD
Professor and Director, Veterinary Medical Sciences Graduate Program, University of Maryland College of Agriculture and Natural Resources

Leigh Ann Soltysiak, MS
Owner, Principal Commercialization & Strategy Consultant, Silverleaf Consulting, LLC

Overview of Subcommittee Tasks and Processes

Dennis reviewed the subcommittee’s responsibilities and upcoming deliverables. The subcommittee’s main purpose is to identify and analyze federal activities that address tick-borne diseases and identify gaps, make observations, and develop a summary of the subcommittee’s findings and analysis. Dennis recommended that the subcommittee focus their efforts on vaccines and therapeutics specifically for Lyme disease, since another subcommittee will cover considerations for other tick-borne diseases. He proposed that the group start their analysis by examining drugs for treating Lyme disease, then look at vaccines. After that, the subcommittee meetings can shift focus to review the findings of the inventory of tick-borne disease projects and activities. The subcommittee should finish their meetings by mid-April to allow sufficient time to compile the report to the working group. In response to Dennis’ timeline guidance, subcommittee members made recommendations on possible presenters for topics.

Issues for the Upcoming National Town Hall Meeting

Dennis asked the group to recommend issues or questions that the working group can present at the upcoming national town hall meeting to gather community input. The subcommittee discussed the likelihood of pushback from some members of the public and considered the best way to present this topic. The following questions were suggested as a way to frame this issue.

  • What are possible barriers to adopting a safe, effective Lyme disease vaccine?
  • What are some possible solutions?

Other Tick-Borne Diseases and Co-Infections

Richard Horowitz welcomed the attendees to the breakout session and facilitated subcommittee member introductions.

Richard Horowitz, Subcommittee Co-Chair

Allen Richards, Subcommittee Co-Chair
Naval Medical Research Center

Megan Dulaney, MS
Senior Interagency Liaison, Henry M. Jackson Foundation for the Advancement of Military Medicine in support of DOD and Center for Health Engagement, Uniformed Services University for the Health Sciences

Marna Ericson, PhD
Assistant Professor, Department of Dermatology; Director, Dermatology Imaging Center, University of Minnesota

Christine Green, MD
Physician, Green Oaks Medical Center, PC; Director, LymeDisease.org; ILADS, Bay Area Lyme Foundation, and Dean Center for Tick-Borne Illness Treatment at Harvard Medical Center

Charles Lubelczyk, MPH
Vector Ecologist, Maine Medical Center Research Institute

Ulrike G. Munderloh, DVM, PhD
Professor, University of Minnesota, Department of Entomology

Garth Nicolson, MD, PhD
President, Chief Scientific Officer and Emeritus Professor of Molecular Pathology, The Institute for Molecular Medicine

Christopher D. Paddock, MD, MPHTM
Rickettsiologist and Pathologist, Rickettsial Zoonoses Branch, CDC

Samuel S. Perdue, PhD
Section Chief, Basic Sciences, Bacteriology and Mycology Branch, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Disease, National Institutes of Health

Sam R. Telford III, ScD
Professor of Infectious Disease and Global Health, Cummings School of Veterinary Medicine, Tufts University

Review of Inventory Document

The subcommittee reviewed the inventory of tick-borne disease projects and activities and discussed whether additional categories should be added or certain aspects of existing categories should be emphasized. They deliberated on whether it is important to include a question about comparisons of relative research spending for other diseases. Several subcommittee members remarked that some other diseases listed under “other tick-borne diseases” are very specific, while other listings refer to broad groups. The subcommittees discussed the need to be consistent in how diseases are listed so that none are omitted. To achieve this consistency, they can specifically identify all other tick-borne diseases or infections within the inventory document or group them into high-level categories that cover all possible diseases and remove specific diseases from the list. In presenting their discussion to the larger working group after the breakout sessions, others recommended specifically listing out each disease and infection.

Identification of Topics

The group brainstormed issues that could be included in the list of issues due as part of the first milestone. Recommendations from subcommittee members included specific tick-borne illnesses or conditions that should be included in the subcommittee’s efforts, such as those that follow:

  • Alpha-Gal,
  • anaplasmosis,
  • bartonella,
  • babesia,
  • Borrelia miyamotoi,
  • mycoplasma,
  • Powassan virus,
  • rickettsia, and
  • tick-borne arboviruses.

Recommendations also included the following overall considerations for addressing tick-borne diseases and co-infections:

  • dermal testing for infections,
  • tick-borne disease effects on the immune system,
  • adult stage deer ticks as a vector,
  • next-generation sequencing to identify multiple pathogens at once,
  • improved diagnosis for other tick-borne diseases (besides Lyme disease),
  • the suites of Ixodes scapularis and Amblyomma americanum pathogens,
  • tick-borne infections that cause high fatality rates (ehrlichiosis, Ehrlichia chaffeensis, rickettsia),
  • prevention of tick bites, and
  • approaches to preventing ticks from being pathogen vectors.

Allen proposed categorizing these issues under the following high-level groupings:

  • Lyme disease co-infections,
  • diagnosis of tick-borne diseases and co-infections,
  • vaccines against ticks and tick pathogens,
  • tick-borne viruses, and
  • tick-borne bacteria.

Report-Outs to Working Group on Subcommittee Meetings

After the breakout sessions, each subcommittee provided the working group with a summary of what their group discussed.

Next Steps

Rich W. noted that subcommittees may need to meet weekly to complete their reporting tasks within the next 13 weeks. In the meantime, the working group will assemble a revised listing of other tick-borne diseases and disseminate it to all subcommittees.

Because the project spans more than 1 year, Rich W. suggested taking a narrower approach to the inventory for the first year’s report, and broadening the scope the following year. He noted that VA has a large dataset that could tremendously benefit the inventory, and moved to include VA in the scope of the first year’s work. The motion was carried unanimously.

Upcoming Meetings

Upcoming meetings include the national town hall meeting, which may become public meeting 4, and the subcommittee presentations to the working group on May 10, 2018. Subcommittee members are welcome to attend this meeting as audience members. After that, the working group will have a 2-day, in-person meeting to begin working through the information provided by the subcommittees. The tentative meeting date is May 14, 2018.

Upcoming Deliverables

More immediately, subcommittees should begin developing the first deliverable, which is to create an inventory of issues and identify and expand upon several priority issues. The next deliverable will be the subcommittee report background sections. The following deliverable will be the methods section of the reports, followed by a description of the first priority.

Report Development

Once the working group has the subcommittee reports, the group will aim to draft the report to Congress by June 21, 2018, and send it out for public comment by July 20, 2018. Following public and agency review, the working group will revise the document and begin the formal clearance process. The working group will then make final revisions and conduct a final review to complete the report by December 2018.

Subcommittee Meetings

Doodle polls will be conducted so subcommittees can determine the best time to set their weekly meetings.

Public Comment

The group discussed how to address the public comments received. A Tick-Borne Disease Working Group mailbox is set up to receive public comments, so individual subcommittee co-chairs or members who receive public inquiries should direct the senders to the Tick-Borne Disease Working Group email address. The inbox has received a large amount of public comment. To handle the volume of public comment, the working group plans to establish a daily internal report and a weekly report to the subcommittees to track the issues raised.

Content created by Office of HIV/AIDS and Infectious Disease Policy
Content last reviewed on May 10, 2018