Thursday, August 26, 2021, 9:00 am—5:15 pm Eastern
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, Designated Federal Officer (DFO) for the Tick-Borne Disease Working Group, Senior Blood and Tissue Policy Advisor, Office of Infectious Disease and HIV/AIDS Policy (OIDP), Office of the Assistant Secretary for Health (OASH), U.S. Department of Health and Human Services (HHS), welcomed all meeting attendees and called the meeting to order. Jim then conducted roll call (see Appendix 1 and Appendix 2: Tick-Borne Disease Working Group Members and HHS Support Staff). Thirteen members and one alternate federal representative of the Tick-Borne Disease Working Group were present.
Co-Chair Welcome and Meeting 19 Agenda
Holiday Goodreau, Executive Director, LivLyme Foundation; Co-creator, TickTracker; Tick-Borne Disease Working Group Co-Chair, welcomed all meeting attendees, noting that they are convened for the task of completing the Working Group’s third and final report to Congress and the HHS Secretary.
Linden Hu, MD, Professor of Microbiology and Medicine and Vice Dean for Research, Tufts University School of Medicine; Tick-Borne Disease Working Group Co-Chair, greeted attendees and reviewed the meeting agenda, as follows.
- Welcome / Member Swear In and Introduction
- Member Introductions
- Overview of the Working Group’s Charter, Mission, Vision, and Values
- Working Group Roles, Responsibilities, and Voting Procedures
- Discussion of the Objectives for the 2022 Report to Congress and the HHS Secretary
- Public Comments
- Update on the National Strategy for Vector-Borne Disease Prevention and Control and LymeX
- Discussion of the Timeline for the 2022 Report to Congress and the HHS Secretary
- Public Comment Subcommittee Discussion
- Discussion of Report Topics, Ideas, and Potential Subcommittees
- Meeting Recap and Next Steps
Official Welcome and Swearing in of Members
Rachel L. Levine, MD, Assistant Secretary for Health (ASH), Department of Health and Human Services welcomed members and the public to the 19th meeting of the Tick-Borne Disease Working Group. She underscored the importance of the meeting as the start of the process of generating the Working Group’s third and final report to Congress and the HHS Secretary. She encouraged collaboration as the Working Group delivers on its charge—as mandated in the 21st Century Cures Act—to review ongoing research and activities conducted by HHS and other Federal agencies, highlight advances made, and identify gaps in research with the goal of generating a cohesive report containing recommendations to reduce the burden of tick-borne diseases in the United States. Dr. Levine emphasized that the Working Group’s 2018 Report to Congress and the HHS Secretary resulted in the enactment of the Kay Hagan Tick Act and ultimately the development of the National Public Health Framework for the Prevention and Control of Vector-Borne Diseases in Humans.
Dr. Levine explained that, as the former Physician General and Secretary of Health of Pennsylvania, she is keenly aware of the toll tick-borne diseases is taking on public health and the lives of patients and their families. To address these issues, she encouraged the Working Group to outline actionable, evidence-based recommendations that incorporate the valuable perspectives of all members, including patients, scientists, clinicians, and policy experts.
Dr. Levine concluded her address by swearing in the seven new public members as special government employees (SGEs).
All members and alternate federal representative who were present introduced themselves and described their experience with tick-borne diseases.
Overview of the Working Group’s Mission, Vision Statement, Values
Jim reviewed the Working Group’s Mission Statement, as follows:
The Tick-Borne Disease Working Group’s mission, as mandated through the 21st Century Cures Act, is to provide expertise and to review all efforts within HHS 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, 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 to 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.
Lastly, Jim read the Working Group’s Core Values in their entirety, as follows:
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.
Review of the Working Group’s Charter and Roles and Responsibilities
Jim gave a high-level overview of the Working Group’s Charter, highlighting relevant laws and key requirements. He explained that the Working Group has been charged with the following tasks.
- Providing expertise
- Reviewing all efforts within HHS related to tick-borne diseases
- Helping to ensure interagency coordination and minimizing overlap
- Examining research priorities
Next, Jim reviewed the FACA requirements that govern the Working Group’s activities. According to the Act, meetings must be open to the public except where a closed or partially closed meeting has been determined proper and consistent with the exemptions of the Government in the Sunshine Act, 5 U.S.C. 552b(c). Public notice of meetings must be published in the Federal Register at least 15 days in advance of the meeting. Any member of the public is permitted to file a written statement with the advisory committee and may speak to or otherwise address the advisory committee if the agency’s guidelines so permit (for example, as a verbal comment during public meetings). Recommendations must be “objective and accessible to the public.” Finally, subcommittees will report and make recommendations to the advisory committee; and the recommendations must be fully discussed and deliberated by the advisory committee before adopting; however, subcommittees are not subject to FACA openness requirements.
Jim noted that the Charter can be viewed in its entirety at the following link.
Jim outlined the roles and responsibilities starting with the co-chairs, who are responsible for:
- Developing meeting agendas;
- Convening meetings;
- Conducting meetings following the Robert’s Rules of Order;
- Approving minutes for the meetings they convene;
- Planning the work of the committee; and
- Working with the DFO and alternate DFO to ensure alignment with the Working Group Charter and Federal Advisory Committee Act (FACA) regulations, and to provide support to the committee.
Jim explained the roles and responsibilities of Working Group members, who are responsible for:
- Providing independent subject matter advise and expertise related to procedures and processes and ensuring relevant information is available;
- Participating in meetings;
- Voting on issues presented;
- Contributing to the work of the Working Group including report recommendations; and
- Participating on subcommittee(s).
Jim added that he and alternate DFO Kay Hayes (Deputy Director, OIDP) are responsible for:
- Ensuring compliance with the FACA and any other laws and regulations;
- Approving agendas provided by the Working Group;
- Calling to order, attending, and adjourning Working Group meetings;
- Ensuring efficient operations; and
- Maintaining required meeting records which, once approved by the Working Group Co-chairs, are placed on the Working Group Website (https://www.hhs.gov/ash/advisory-committees/tickbornedisease/index.html).
Finally, Jim identified the roles and responsibilities of the companies contracted to provide meeting, writing, and communications support, as follows:
- Assisting with planning and staffing public meetings;
- Attending public meetings to take notes and draft summaries;
- Coordinate and attend all subcommittee meetings;
- Assisting subcommittees in preparing meeting agendas and reports to Working Group; and
- Assisting the Working Group in preparing the report to Congress and the HHS Secretary.
Working Group Objectives and Duties
Linden reviewed the Working Group’s duties, as follows:
- No later than two years after the date of enactment of the authorizing legislation, develop or update a summary of:
- Ongoing tick-borne disease research, including research related to causes, prevention, treatment, surveillance, diagnosis, diagnostics, duration of illness, and intervention for individuals with tick-borne diseases;
- Advances made pursuant to such research;
- Federal activities related to tick-borne diseases, including
- Epidemiological activities related to tick-borne diseases; and
- Basic, clinical, and translational tick-borne disease research related to the pathogenesis, prevention, diagnosis, and treatment of tick-borne disease;
- Gaps in tick-borne disease research described in 3b;
- The Working Group’s meetings; and
- The comments received by the Working Group.
- Make recommendations to the Secretary regarding any appropriate changes or improvements to such activities and research; and
- Solicit input from States, localities, and non-governmental entities, including organizations representing patients, health care providers, researchers, and industry regarding scientific advances, research questions, surveillance activities, and emerging strains of pathogenic organisms.
Update on the National Strategy for Vector-Borne Diseases and LymeX Innovation
Kristen Honey, PhD, PMP, Chief Data Scientist, Executive Director of InnovationX, Office of the Assistant Secretary for Health, Department of Health and Human Services, provided updates on the 1) National Public Health Strategy for the Prevention and Control of Vector-Borne Diseases in Humans; 2) LymeX Innovation; and 3) National Public Health Framework for the Prevention and Control of Vector-Borne Diseases in Humans. She gave an overview of the geographic distribution of ticks, highlighting their expansion and identifying the factors contributing to the spread of vector-borne diseases, including climate change.
Kristen explained that the following two executive orders guide the major priorities supported by InnovationX: Tackling the climate crisis at home and abroad; and protecting public health and the environment and restoring science to tackle the climate crisis. She outlined the priorities as follows:
- InnovationX is working across OASH and CDC to develop and implement a National Strategy for vector-borne diseases to “increase resilience to the impacts of climate change and protects public health.”
- InnovationX is “listening to the science; to improve public health and protect our environment” by focusing on the intersection between science and policy on the effects of climate change on Lyme and tick-borne diseases.
- InnovationX supports and leads the $25 million LymeX Innovation Accelerator between HHS and the Steven and Alexandra Cohen Foundation, “developing programs, policies, and activities to address the disproportionately high and adverse human health, environmental, climate-related and other cumulative impacts on disadvantaged communities.”
- InnovationX is deploying the human-centered design methods with a LymX Health+ cycle to “address the impact of climate change on the health of the American people.”
Kristen outlined the timeline for the development of the National Strategy, beginning with the passage of the Kay Hagan Tick Act in December 2019, which called for its creation, and concluding with the National Strategy Report to Congress in December 2023. She noted that two major objectives of the National Strategy are to “execute human-centered design methods in listening, identifying, developing, and prioritizing advancements in care that foster innovations which can deliver transformative improvements on patients’ quality of life” and “identify common challenges in patient and healthcare provider experiences.”
Kristen then commented that the National Public Health Framework for the Prevention and Control of Vector-Borne Diseases in Humans was developed by the Centers for Disease Control and Prevention (CDC), five Federal departments, and the Environmental Protection Agency (EPA) and involves collaborations between many stakeholders, including LymeX Tick-Borne Disease Innovation Accelerator, the Tick-Borne Disease Working Group, regional centers of excellence in vector-borne diseases, and following:
- The Federal government, including the Office of the Assistant Secretary for Health (OASH), and CDC;
- Health departments;
- Vector control agencies;
- Healthcare providers;
- Academic and industry partners;
- Policy and decision makers;
- Public health partners; and
- The public and patients.
Kristen added that the National Framework aims to “identify and assess gaps and unnecessary duplication in federally funded programs; set benchmarks to measure progress toward addressing vector-borne diseases; and engage in interagency coordination through pilot programs.” She outlined the vision, mission, and objectives as follows.
Vision: A nation where vector-borne diseases no longer threaten human health and well-being.
Mission: Protect people from illness, suffering, and death due to vector-borne diseases.
- Better understand when, where, and how people are exposed to and get sick or die from vector-borne diseases.
- Develop, evaluate, and improve tools and guidance for the diagnosis and detection of vector-borne diseases.
- Develop, evaluate, and improve tools and guidance for the prevention and control of vector-borne diseases.
- Develop and assess drugs and treatment strategies for vector-borne diseases.
- Disseminate and support the implementation of effective public health and vector control products, tools, and programs to prevent, detect, diagnose, and respond to vector-borne disease threats.
Kristen returned to the National Strategy and explained that a request for information (RFI) had been sent out in April 2021 regarding the development of the National Public Health Strategy for the Prevention and Control of Vector-Borne Diseases in Humans, which resulted in approximately 200 responses. She noted that common themes shared among commenters who mentioned climate as a concern were: surveillance, monitoring, and data-sharing; control; research; funding; and education and training.
She concluded her presentation of the National Strategy by outlining next steps, as follows:
- September 2021: Synthesize inputs, goals, strategies, and priorities for “developing the National Public Health Strategy for Prevention and Control of Vector-Borne Diseases in Humans”
- October 2021: First virtual stakeholder meeting
- October 2021 – December 2023: Interim updates to stakeholders at Tick-Borne Disease Working Group public meetings and continued public inclusion efforts to listen and learn
- December 2023: Submission of the Report to the Senate Committee on Health, Education, Labor, and Pensions to show progress on vector-borne and tick-borne diseases.
Kristen then provided an update of the LymeX Innovation Accelerator, which she described as a “$25 million three-year public-private between HHS and the Steven & Alexandra Cohen Foundation to harness the power of collaboration, data-driven innovation, and emerging technologies for Lyme and tick-borne diseases.” She described the LymeX objectives as follows.
- Patient-centered innovations: Executive human-centered design methods in identifying, developing, and implementing innovative advancements in disease care.
- Education and awareness: Focus on innovative health education that brings light to tick-borne disease prevention using open innovation methods.
- Next-gen diagnostics: Prize challenges open to universities, non-profits, and private sector for cross-sector, next gen patient-centered diagnostic innovations.
Kristen explained that patient-centered innovations include ongoing stakeholder engagement in the form of interviews, listening sessions, LymeX workshops, and public events, as well as basic research to identify and address the impact of climate change and health equity on the health of the American people. She outlined the LymeX timeline and milestones, beginning with its launch in 2020 and ending with a grand prize reward for the “LymeX Diagnostics ‘Moonshot’ competition, including FDA approval, and LymeX support expansion.
Kristen encouraged public engagement on both the National Strategy and LymeX Innovation and provided the email addresses for both.
National Strategy: firstname.lastname@example.org
Presentation Q & A
Holiday thanked Kristen for her presentation and opened the meeting to questions from members.
Jennifer Platt, DrPH, MSPH Co-founder, Tick-Borne Conditions United, asked how the recommendations of the Working Group’s 2020 Report to Congress and the HHS Secretary will be incorporated into the National Strategy, noting that recommendations from the Working Group’s 2018 Report contributed to the passage of the Kay Hagan Tick Act.
Kristen responded that both reports will be instrumental to the National Strategy. She explained that the 2018 Report focused on Lyme disease, whereas the 2020 Report was dedicated to all tick-borne diseases and conditions. She stated that the first report provided depth while the second report provided breadth, both of which are vital to the National Strategy. She expressed her keen interest in what the Working Group will focus on in its third report.
Jennifer also asked how people struggling with multiple illnesses factor into the LymeX initiative.
Kristen replied that, although LymeX is focused primarily on Lyme disease, the population it engages includes anyone who has experienced Lyme disease in any way, regardless of their test results. She explained that LymeX hears from patients, caregivers, practitioners and anyone with lived experience of Lyme disease and any concurrent infections or illnesses that often accompany it. This, she noted, is the basis for the human-centered design approach.
Monica E. Embers, PhD, Associate Professor and Director, Vector-borne Disease Research, Tulane National Primate Research Center, asked if there would be research funding opportunities through LymeX.
Kristen responded that LymeX will not offer any traditional types of funding in the way that the National Institutes of Health (NIH) offers research grants, for example. She explained that LymeX will provide opportunities for innovators to win awards through challenges, noting that the current challenge is for a new diagnostic tool. She suggested that the Working Group may be able to identify areas of funding through the National Strategy and in particular by examining the President’s budget, which she noted, is an indicator of where the administration intends to make investments.
Linden commented that there may be potential overlap between the Working Group’s mission and that of the National Strategy. He asked how the two groups can work together to enhance each other’s work, specifically for the Federal Inventory.
Kristen agreed that it will be important to make efficient use of all available resources. She noted that the National Strategy will soon conduct a Federal Inventory, the results of which can be made available to the Working Group. She encouraged the Working Group to leverage the National Strategy efforts as needed.
Holiday introduced the public comment session. She briefly explained the process for providing verbal comments at the meeting and the time allocated for each commenter (3 minutes). She reminded the public of the three ways to provide comments to the Working Group: 1) providing oral public comments at public meetings; 2) submitting written public comments for a public meeting by email to email@example.com; and 3) sending comments anytime by email to firstname.lastname@example.org).
Ten members of the public provided comments over the phone.
Christopher Reilly. Christopher asserted that Lyme disease patients have been repeatedly misled over several decades about the immunosuppressive nature of the illness. He described how Lyme disease leaves the sickest Lyme disease patients with acquired immunodeficiency, which he likened to that of AIDS. Christopher stated that changes made in 1994 to the case description and Lyme disease testing protocol resulted in preventing immunosuppression from being detected. Christopher noted that the modifications to the testing protocol were made despite protests from attendees. He also expressed criticism of the LYMErix vaccine. He wondered how many people in this country, in particular during this COVID-19 pandemic, are unaware of their immunosuppressed status. He contended that faulty testing also affects people with autoimmune and neurological conditions. He urged the Working Group to help rectify the testing protocol to address this situation.
Jennifer Hyla. Jennifer stated that she is a disabled Veteran from Washington state. She described how she contracted Lyme disease during deployment training in 2011, her subsequent struggles to obtain an accurate diagnosis, and the debilitating symptoms she still faces. She cited that according to the International Lyme and Associated Diseases Society (ILADS), the average Lyme disease patient takes two to five years to get properly diagnosed. Jennifer commented that the hurdles to receiving prompt treatment include consideration of Lyme disease in the differential diagnosis, getting an accurate test result, and finding a doctor willing to treat patients. She pointed out that, given the high treatment failure rates and harsh penalties for treating outside CDC protocols, many doctors refuse to treat Lyme disease patients. Jennifer asserted that since Lyme disease was first identified, the government has failed to curb new cases, stop the geographic spread, or rectify testing and treatment failures. Jennifer pleaded for bold and immediate action to better understand the pathogens of Lyme disease and other common tick-borne illnesses and to educate the public and medical professionals.
John Mathaga. John, from the Republic of Kenya, expressed his keen interest in this Tick-Borne Disease Working Group meeting. He explained that he has an allergy to red meat, which first took hold in his youth. He added that his grandmother used a concoction that relieved his symptoms. He reported that he later used this concoction in other people’s cases with success. John explained that in 2017, while doing research, he came across Alpha-gal Syndrome. He asserted that he believes there is a connection between red-meat allergy and Alpha-gal Syndrome and that the issue is linked to a microbe. He communicated his hope that these types of allergies can be overcome and that he can help contribute to a solution.
Dorothy Leland. Dorothy stated that she represents LymeDisease.org. She indicated that she wished to address a topic left that received little attention in the Working Group’s first two reports: the severe impact of Lyme disease on mental health. She cited a recently published study about the high incidence of suicide among people with Lyme disease. She explained that when patients express their concerns about mental health and seek help from their physicians, they are often dismissed. She noted that many patients describe feeling as though they have been treated disrespectfully by medical professionals. She reported that according to LymeDisease.org, a major driver of the increased suicide rates among Lyme disease patients is that they are disbelieved, stigmatized, gaslighted by physicians, by insurance, often by society, and sometimes by their own families. Dorothy urged the Working Group to listen to patients, and to help change the system that deprives people with Lyme disease of the medical care they need to get well.
Dr. Robert Bransfield: Dr. Bransfield, a psychiatrist from New Jersey, stated that he had treated thousands of Lyme disease patients over 30 years. He cited studies that demonstrate Lyme disease as a cause of mental illness, resulting in disability and death from tick-borne diseases. He underscored that current Infectious Diseases Society of America (IDSA) guidelines fail to recognize the causal association between tick-borne diseases and psychiatric symptoms, affective disorders, cognitive impairments, addictions, and other debilitating psychological impairments. He asserted that as a result, the guidelines are out of date. He suggested that, with input from psychiatrists, the Working Group gather information on psychiatric symptoms caused by tick-borne diseases and share it with legislators and the public. He also urged the Working Group to recommend that all Federal and government links and references to the IDSA guidelines be removed.
Meghan Bradshaw. Meghan shared that she is 28 years old and a tick-borne disease patient. She expressed dismay that the lack of accurate diagnostics resulted in preventable illness. She recounted how she had been misdiagnosed, which allowed the disease to proliferate. She listed an array of lifestyle changes, diets, and medications that yielded no improvements in her condition. She described the series of surgeries needed to address fused joints throughout her body. She explained that she now requires assistance for daily living and the most basic tasks. She detailed the many types of damage the disease inflicts, from the physiological and emotional, to the extreme financial devastation. Meghan wondered why this illness, twice as common as breast cancer, is not tested in routine exams, like mammograms. She pointed out that tick-safety education is a simple, cost-effective measure that could prevent devastating outcomes.
Marta Edmisten. Marta introduced herself as a 47-year-old who had her first known tick bite around the age of six. She explained that she is currently living with several infections, including babesiosis, Bartonella, and active Lyme disease. She recounted how the endocrine issues she developed after the first tick bite were so severe that she was followed by the head of a prominent children’s hospital for 14 months, without the cause ever being discovered. She disclosed the many physiological, emotional, and psychological symptoms that developed over the years despite negative test results and misdiagnoses. She described the many treatments she underwent, as well as her second known tick bite, which was also missed as the source of the rash on her neck. Marta reported finally being tested for Lyme disease and coinfections in 2016 and starting treatment thereafter. She underscored how, despite feeling better, she still is extremely disabled. She stressed the critical importance of believing patients and helping them when they report being ill.
Laura Hovind. Laura stated that she is the Executive Director of the nonprofit TruthCures. She criticized the Lyme disease case definition, explaining that from as early as 1991, it has intentionally excluded the sickest cases who are often found to be seronegative. She expressed frustration that instead of developing better diagnostic tools, testing is allowed to reflect results that leave out the sickest cases, and vaccines are permitted to show successful trials thanks to a case definition that excludes individuals who are most ill. She asked what the Working Group’s responsibility is to address these circumstances, which affect the sickest patients, and urged its members to take the proper actions.
Kristina Bauer. Kristina indicated that she is the Executive Director of Texas Lyme Alliance, the mother of four children with congenital Lyme disease, and a patient of 41 years. She criticized the country’s healthcare system for its failure to diagnose and treat Lyme disease patients who are chronically ill, which she added, has resulted in significant suffering and death. She cited the high treatment failure rates that have been repeatedly documented in the medical literature. She listed as a major problem the lack of research to develop and implement accurate diagnostics and effective treatment for the most extreme cases. Kristina commented that despite the Affordable Care Act’s stance on extended antibiotic treatment for persistent infection, IDSA, CDC, NIH, and private insurers continue to limit the use of antibiotics. She added that inaccurate diagnostics tests are often used to deny treatment. She concluded by stating that the ambiguous term “post-treatment Lyme disease syndrome” or PTLDS has no ICD code or recommended treatment.
Kathleen Wallace. Kathleen shared that she is from upstate New York and has been a Lyme disease patient advocate since her diagnosis with Lyme disease. She revealed that she has multiple chemical sensitivities or MCS, characterized by adverse health effects from exposure to common chemicals and pollutants from a wide range of everyday products. She explained that the symptoms can be life-threatening and include headaches, trouble concentrating, nausea, diarrhea, fatigue, muscle and joint pain, dizziness, difficult breathing, irregular heartbeat, and seizures. She underscored how, with MCS, quality of life is severely impaired and isolation a common consequence. She pointed out that Gulf War veterans and 9/11 survivors have similar symptoms. She called for recognition of MCS, including a medical code, further research, education for physicians, and better air quality control. She offered her expertise and knowledge as a patient to help make a difference in the lives of those suffering from MCS.
Timeline for the 2022 Report to Congress and the HHS Secretary
Holiday began the afternoon’s discussion by reviewing the Working Group’s timeline for completing its 2022 Report to Congress and the HHS Secretary, highlighting that the subcommittees will need to complete their work by January 7, 2022, at which time the subcommittee co-chairs will submit their respective reports to the Working Group. She added that the final report is due to Congress and the HHS Secretary by December 2022 when it will also be posted on the Working Group’s website.
Proxy Voting Discussion
Holiday explained that before making decisions about subcommittees, the Working Group needs to decide if proxy voting should be allowed at this and future meetings. She explained that Federal members have alternates who can attend meetings on their behalf; however, public members do not. She encouraged all members to attend meetings, then asked the group to discuss and vote on whether or not members should be able to assign a proxy in their absence.
Jennifer noted that attendance was a concern in previous years.
Elizabeth (Betty) Maloney, MD, President, Partnership for Tick-Borne Diseases Education, stated that she is against proxy voting because votes takes place after a discussion among members, and if a member is not present for that discussion, then their proxy vote is not informed.
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, agreed with Betty, noting that proxy voting was a contentious issue during the 2020 process.
Jennifer agreed and added that proxy voting is not meaningful because members cannot predict what discussions or votes will take place.
Motion and Discussion
Holiday made a motion to not allow proxy voting at Working Group meetings during the 2021 to 2022 process.
Samuel 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 (NIAID), National Institutes of Health (NIH), U.S. Department of Health and Human Services, seconded the motion.
CDR Todd Myers, PhD, HCLD (ABB), MB (ASCP), Office of Counterterrorism and Emerging Threats (OCET), Office of the Chief Scientist, Office of the Commissioner, U.S. Food and Drug Administration, U.S. Department of Health and Human Services, asked if the vote applies to all Working Group members or just public members.
Linden stated that the vote should apply to all Working Group members who should only be able to vote when they have participated in the relevant discussion.
Holiday and Ben agreed. Ben added that Federal members occasionally assigned proxy votes at previous meeting.
Thirteen members voted yes to not having proxy votes for any members during the 2021 to 2022 process. One member voted no. The motion passed.
Subcommittee Discussion: Public Comments Subcommittee
Linden began the discussion of subcommittees by explaining that the Working Group formed a Public Comments Subcommittee in 2018 that meets monthly to review public comments and synthesize them for the Working Group’s consideration in their reports. He added that the Working Group must decide if this subcommittee should continue and encouraged discussion.
Betty commented that she would like the subcommittee to continue because it allows the Working Group to hear from the patients and patient advocates who helped initiate the 21st Century Cures Act.
Jennifer agreed, noting that patient, provider, and public input represents important qualitative data, which complements the quantitative data collected by the subcommittees and Working Group.
Monica, Holiday, and Linden also agreed, highlighting the importance of hearing from patients and the public.
The Working Group decided to continue the Public Comments Subcommittee. Linden and Holiday offered to co-chair the subcommittee.
Subcommittee Discussion: Other Subcommittees
Holiday explained that the next item on the agenda is to determine what topics will be covered in the 2022 Report to Congress and the HHS Secretary and which subcommittees should be formed in order to collect the information needed. She added that, if time allows, the Working Group will also select co-chairs for each subcommittee. She encouraged members to think of five to six important topics that will yield actionable recommendations for Congress and the HHS Secretary, noting that conciseness is important as members of Congress will have little time to process the report. Holiday also encouraged the public to reach out to their representatives and encourage them to read the Working Group’s reports.
Linden explained that, based on submissions from the Working Group members, he and Holiday compiled the following two options for the Working Group members to consider, discuss, and revise as needed.
Option 1: Review and Coordination
Structure: Create subcommittees similarly to the prior Tick-Borne Disease Working Group but focus subcommittees on understanding governmental spending and identifying gaps in follow through from prior committee recommendations.
Rationale: The previous two Working Groups have already spent considerable effort in examining research priorities. The focus of this Working Group will be on the first two points of the mission (i.e., providing expertise and reviewing all efforts within HHS; helping to ensure interagency coordination and minimizing overlap).
- Prevention/tick migration
- Other tick-borne diseases
Option 2: New and Orphan Topics
Structure: Have similar subcommittees as before but narrow the focus to only hot button topics, new advances, and issues not covered in depth by prior committees. The goal is to create guidance that extends but does not overlap with the 2018 and 2020 reports.
Rationale: Utilize the third Working Group report to extend the scope of the first and second Working Groups.
Potential subcommittee example with possible areas of focus:
- Pregnancy and Lyme disease
- Clinical trials network
- Other tick-borne diseases
- Alpha-gal Syndrome
- Powassan virus
- Post-treatment Lyme disease
- Long-haul COVID-19 and its relationship to Lyme disease
- Prevention/tick migration
- Federal inventory
Discussion of Options 1 and 2
Holiday asked Working Group members to discuss the two options presented.
Gabriella Zollner (Romero), PhD, Program Manager, Deployed Warfighter Protection Program, U.S. Department of Defense, stated that she prefers option 2, to extend what the Working Group has already done in its previous two reports. She added that she favors having a separate subcommittee devoted to examining post-treatment Lyme disease and parallels with long-haul COVID-19.
Betty emphasized the importance of including access to care and education of practitioners because there are facets that have not been covered previously and there continue to be major shortfalls in these areas. She suggested that the Working Group be more directive in their recommendations for these two topic areas.
Ben underscored the importance of highlighting in the third report previous recommendations that have not been implemented. He suggested that an entire subcommittee be devoted to reviewing past recommendations and identifying areas where little action has been taken.
Monica stated that she sees value in both options and suggested creating subcommittees devoted to the broader topics with orphaned topics, such as pregnancy and mental health, incorporated as subtopics where appropriate.
CDR 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, commented that she agrees with doing an inventory of recommendation status (as suggested by Ben) and including access to care and clinician education in the subcommittee structure.
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, noted that the creation of the Vector-Borne Disease Strategy may aid in the implementation of previous and future recommendations. He also stated that the current administration and Secretary of Health have prioritized health equity, which creates a more conducive environment for access to care recommendations.
Sunil K. Sood, MBBS, DCH, MD, Chair of Pediatrics, South Shore University Hospital; Attending Physician, Infectious Diseases, Cohen Children’s Medical Center; Professor of Pediatrics and Family Medicine, Zucker School of Medicine at Hofstra/Northwell, agreed with Ben that it is important to reference and update previous report content but not spent too much time reiterating what has already been stated.
Jennifer observed that the Working Group seems to be leaning toward a hybrid of options 1 and 2, which would include both depth and breadth for a more rounded presentation of the issues. She advocated for having a subcommittee devoted to mental health impacts; and she highlighted the importance of discussing equity, financial impacts, and the changing dynamics of tick populations, including range expansion and behavioral components (for example, lone star ticks are hunters). She suggested that the Working Group present not just current issues, but anticipated challenges.
Kirby C. Stafford III, PhD, MS, Chief Scientist and State Entomologist, Department of Entomology, Center for Vector Biology & Zoonotic Diseases, The Connecticut Agricultural Experiment Station, noted there is documented range expansion for lone star ticks, Asian long-horned ticks, and Gulf Coast ticks. He recommended that the Working Group consider tick bite prevention, as well as tick mitigation and control.
Betty suggested changing “other tick-borne diseases” to “concurrent infections” with consideration for reactivation of viruses, which has not been covered in previous reports.
Holiday underscored the importance of looking for synergistic opportunities with long-haul COVID-19 work. She also emphasized the importance of protecting children from tick-borne diseases, which includes understanding congenital issues.
Monica agreed with Betty about using the term “concurrent infections” and including coverage of Bartonella as a complicating factor. She also agreed that the Working Group should investigate variation in human response (and its effect on serodiagnosis and treatment), the effects of neuroborreliosis on mental health, and congenital Lyme disease.
Betty commented that the literature on maternal/fetal transmission is incomplete. She also cautioned the group about relying too heavily on comparisons between long-haul COVID-19 and Lyme disease because they have different causes. She added that the Working Group should be sure to maintain the uniqueness of Lyme disease in its report.
Ben indicated that the Vector-Borne Disease Strategy will conduct a climate assessment report, so rather than focus specifically on climate change, he suggested that the Working Group look at changing ecology, environmental change, and changes in disease ecology and epidemiology, as suggested by Jennifer. He added that the Working Group could consider how much of the tick changes in distribution are related to climate change as opposed to factors such as habitat fragmentation and urban sprawl. He noted that there could be a subcommittee devoted to these topics and another to chronic tick-borne illness and parallels with long-haul COVID-19.
Linden noted that diagnostics are an important factor to consider, as the illnesses are difficult to treat if their cause is unknown.
At this point, Holiday encouraged the group to consider five to six important topic areas that need attention and think about the subtopics that would fall underneath them. She added that she and Linden will co-chair the Public Comments Subcommittee and will, therefore, not chair the other subcommittees.
Linden noted that the Federal Inventory information collected by the National Strategy group could be parsed out to the relevant subcommittees for consideration.
Sam suggested including other tick-borne diseases under each major category (as relevant) rather than breaking them out into a separate group.
Betty agreed with Sam, adding that including other tick-borne diseases under the major categories gives them appropriate context. She suggested that each subcommittee could report on new evidence for each disease and condition since the 2020 report.
Monica and Linden agreed that it will be important to highlight what has been implemented and what remains to be done, and create actionable, achievable recommendations.
Linden suggested including other tick-borne diseases and education under each major category as they relate to all of them.
Betty expressed concern about placing concurrent infections as a subheading under the major categories because they may not get the attention they deserve. She added, however, that it would be an efficient approach.
Holiday underscored the importance of knowing the audience and providing them with a clear, concise road map for funding initiatives, implementing research, and starting new programs.
Gabriella commented that Lyme disease coinfections and concurrent infections intersect with all topics and suggested that all subcommittees consider them as they prepare their reports.
Jennifer recommended incorporating the concept of marketing personas into the report presentation, noting that LymeX has conducted hundreds of hours of interviews with people suffering from chronic tick-borne illnesses. She added that the goal would be to present relatable stories that would resonate with members of Congress.
Ben agreed with Gabriella’s previous comment that Lyme disease coinfections and concurrent infections should be integrated into all subcommittees because the Working Group has already devoted an entire subcommittee to the topic, so the 2022 subcommittees can focus on providing updates.
Monica expressed concern that reactivation of Epstein-Barr virus and concurrent infection with Bartonella would not receive coverage in the subcommittees. She noted that it is important to consider prevalence of coinfections and how concurrent and coinfections affect diagnosis and treatment.
In response, Linden suggested that the Working Group ask the subcommittees to consider these topics.
Sam noted that the previous Other Tick-Borne Disease subcommittee focused primarily on coinfections with Lyme disease. He suggested that the 2022 subcommittees consider disease presentations outside of Lyme disease. He also suggested the possibility of devoting an entire subcommittee to new and emerging issues that have not been previously covered.
Leith highlighted the importance of using language that resonates with members of Congress. He described current initiatives within the Federal government to modernize surveillance, overhaul the public health infrastructure, and fund COVID-19 efforts and suggested framing recommendations in ways that leverage current activities. He also suggested focusing on specific topics such as changing disease ecology rather than the broad topic of climate change.
Ben added that HHS and CDC are doing significant work in the areas of surveillance and reporting and data modernization. He noted that the COVID-19 pandemic highlighted how outdated the systems are for data management, analytics, and forecast modeling and stated that there is a lot of funding devoted to these areas.
Linden commented that the One Health concept was covered in the previous report.
Ben clarified that One Health received some coverage related to the topics of vector surveillance, animal surveillance, and disease reporting.
Regarding reimbursement and access to care, Rebecca pointed out that the Innovation Center —under the Centers for Medicare and Medicaid Services (CMS)—is currently focused on novel model development and innovation-based care, as well as quality improvements and cost reductions. She suggested that the Working Group develop a recommendation for CMS to conduct testing through the Innovation Center in the areas of cost and quality that would include industry and health care organizations.
Jennifer acknowledged that Congress is the principal audience for the report, but she underscored the importance of including insurance companies, educators, and other stakeholders as potential audiences because many of them do not understand or are unaware of access to care issues.
Gabriella asked for clarification about how the previous subcommittees informed the 2018 and 2020 Reports to Congress and the HHS Secretary.
Review of Previous Reports, Recommendations, and Subcommittees / Continued Discussion of Options 1 and 2
At this point in the meeting, the Working Group looked at the 2018 and 2020 reports, recommendations, and subcommittees.
As someone who was part of the Working Group since its inception, Ben explained the previous processes and described how the subcommittees’ reports translated into the 2018 and 2020 Working Groups’ Reports to Congress and the HHS Secretary.
The group discussed the merits of having the subcommittee descriptors match the chapters of the 2022 Report to Congress and the HHS Secretary, noting that it would be simple if the subcommittee reports translated directly to the chapters of the Report to Congress and the HHS Secretary. They also discussed the challenges of this approach. Jennifer commented that it may be too limiting to restrict the Working Group’s report chapters to the subcommittee topics identified at this meeting.
Betty and Ben differentiated between diagnosis and diagnostics. Betty, Ben, Linden, and Holiday agreed that diagnosis relates to clinical practice and belongs within the broader categories of access to care and education; and diagnostics relates to the shortfall of testing tools and how they’re validated.
Jennifer and Holiday asked where mental health falls under the major categories.
Ben recommended placing mental health under clinical presentations and pathogenesis, which would include consideration of how the disease presents itself and the underlying mechanisms.
Kirby suggested placing long-haul COVID-19 under clinical presentations and pathogenesis for the same reasons.
Holiday noted that long-haul tick-borne disease and neurological Lyme disease belong under the clinical presentations and pathogenesis heading as well.
To cover prevention and tick mitigation, Ben, Jennifer, and Holiday jointly suggested having a subcommittee entitled “Changing Dynamics of Tick Ecology, Personal Protection, and Control” with subcategories devoted to changing landscape ecology, drivers such as climate and environmental change, range expansion, new tick species, controlling ticks, tick behaviors, and preventing illness in humans.
Betty asked for clarification on what is meant by tick prevention and what category human vaccines fall under.
Ben explained that tick prevention could mean anti-tick vaccines, repellants, pesticides, integrative pest management, and other validated tools.
Sam suggested that the human vaccine be placed under prevention.
Leith noted that it might be appropriate to differentiate between individual prevention and population-/community-level prevention.
Betty recommended placing pregnancy under the broader pathogenesis category.
Sunil suggested that tick bite management be included with provider education.
Selection of Subcommittee Co-Chairs
The Working Group concluded its discussion of subcommittee topics and moved on to the selection of co-chairs for each subcommittee. Working Group members volunteered to serve as co-chairs, ensuring that each subcommittee had one public member and one Federal member.
2022 Tick-Borne Disease Working Group Subcommittees and Co-Chairs
The meeting’s discussions resulted in the following subcommittees, preliminary subtopics, and co-chairs.
2022 Tick-Borne Disease Working Group Subcommittees and Co-Chairs
- Diagnostics (technical needs)
- Cover all TBDs
- Develop and validate new tests
- Gaps and limitations in current Testing
- Most promising techniques on the horizon, real-time tests
- Approval and standardizations processes
- Deeper dive into the roadblocks for better testing
- Testing for surveillance (?)
Co-chairs: Monica, Todd
- Clinical Presentation and Pathogenesis
- Cover all TBDs
- Mental health
- COVID long haulers
- TBD long haulers
- Neurological Lyme
- Pregnancy and Lyme
- Virus reemergence
Co-chairs: Ben, Jennifer, Leith
- Changing Dynamics of Tick Ecology, Personal Protection, and Control
- Cover all TBDs
- Climate change
- Environmental change
- Control ticks and prevention including Integrated Pest Management (IPM)
- Range expansion
- New tick species and behavior
- Pest control
- State of science for prevention tools
- Built environment change
- Individual vs. community
- Tick, pathogen prevention
Co-chairs: Kirby, Robert
- Disease Prevention and Treatment
- Cover all TBDs
- prophylaxis & treatment (including therapeutics)
- Clinical trials network
- Primary, Secondary, and Tertiary Prevention
- What better treatments are needed
- comprehensive testing of treatment regimens aimed at persistent disease
Co-chairs: Dennis, Sunil
- Access to Care and Education
- Management of tick bite
- Research for therapeutics
- Education awareness for practitioners,
- TBD as a public health issue
- Shared decision making (Patient – provider relationship)
- Out of pocket expenses not covered by insurances, CMMI model (value-based care)
- Engage with other areas within CMS (i.e., coding group)
- Travel, people outdoors
Co-chairs: Betty, Rebecca
- Public Comment Subcommittee
Co-chairs: Linden and Holiday, Gaby, Jennifer
Motion and Discussion
Linden made a motion to accept the subcommittees and co-chairs as listed above.
Betty seconded the motion.
Ben commented that he felt there should be at least one clinician on the Clinical Presentation and Pathogen Subcommittee, at which time Leith was added as a co-chair.
The motion was amended to include this change, and Betty seconded the amended motion.
Thirteen members voted yes to accept the subcommittees and co-chairs as listed above. One member abstained. The motion passed.
Closing Remarks, Next Steps, and Adjournment
Holiday thanked Working Group members for their hard work and time. She asked that subcommittee co-chairs convene within the next few days to compile their lists of potential subcommittee members. She added that Working Group members can make suggestions to each other as they see fit.
Holiday stated that the next meeting will be held in early 2022, either before or after CDC’s Vector-Borne Disease Week.
Linden thanked everyone for their participation, adding that he is looking forward to a good year.
The meeting was adjourned at 5:19 pm Eastern.
Appendix 1: Tick-Borne Disease Working Group Members
In alphabetical order:
Holiday Goodreau, Executive Director, LivLyme Foundation; Co-creator, TickTracker (Present)
Linden Hu, MD, Professor of Microbiology and Medicine, Vice Dean for Research, Tufts University School of Medicine (Present)
Charles Benjamin (Ben) Beard, PhD, Deputy Director, Division of Vector-Borne Diseases, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services; Associate Editor, Emerging Infectious Diseases (Present)
CDR 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 (Present)
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 (Absent)—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)
Monica E. Embers, PhD, Associate Professor and Director, Vector-Borne Disease Research, Tulane National Primate Research Center (Present)
Elizabeth Maloney, MD, President, Partnership for Tick-borne Diseases Education (Present)
Robert J. Miller, PhD, National Program Leader, Agricultural Research Service, United States Department of Agriculture (Present)
CDR Todd Myers, PhD, HCLD (ABB), MB (ASCP), Office of Counterterrorism and Emerging Threats, Office of the Chief Scientist, Office of the Commissioner, U.S. Food and Drug Administration, U.S. Department of Health and Human Services (Present)
Jennifer Platt, DrPH, MSPH, Co-founder, Tick-Borne Conditions United (Present)
Sunil K. Sood, MBBS, DCH, MD, Chair of Pediatrics, South Shore University Hospital; Attending Physician, Infectious Diseases, Cohen Children’s Medical Center; Professor of Pediatrics and Family Medicine, Zucker School of Medicine at Hofstra/Northwell (Present)
Kirby C. Stafford III, PhD, MS, Chief Scientist and State Entomologist, Department of Entomology, Center for Vector Biology & Zoonotic Diseases, The Connecticut Agricultural Experiment Station (Present)
Leith Jason States, MD, MPH (FMF), Deputy Chief Medical Officer, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services (Present)
Gabriella Zollner (Romero), PhD, Program Manager, Deployed Warfighter Protection Program, U.S. Department of Defense (Present)
Appendix 2: HHS Support Staff
In alphabetical order:
James (Jim) Berger, MS, MT (ASCP), SBB, Designated Federal Officer, Tick-Borne Disease Working Group, Senior Blood and Tissue Policy Advisor, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services
B. Kaye Hayes, MPA, Alternate Designated Federal Officer, Tick-Borne Disease Working Group, Deputy Director, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services
Chinedu Okeke, MD, MPH-TM, MPA, Senior Policy Advisor, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services
Lauren Overman, MPH, CPH, Public Health Analyst, 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, Public Health Analyst, 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, MPH, Public Health Analyst, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services