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 isciplines represented in this document. All perspectives and expertise, including patient-lived experience, is valued equally. Speaking on a first-name basis helps the Tick-Borne Disease Working Group ensure that all voices are heard and valued based on merit and without the bias of titles, eminence, or prestige.
Welcome and Roll Call
James (Jim) Berger, MS, MT (ASCP), SBB, Senior Blood and Tissue Policy Advisor, Office of Infectious Disease and HIV/AIDS Policy (OIDP), Office of the Assistant Secretary for Health (OASH), U.S. Department of Health and Human Services (HHS); Designated Federal Officer (DFO) for the Tick-Borne Disease Working Group, called the meeting to order and welcomed all meeting attendees. Jim then conducted roll call (see Appendix 1 and Appendix 2: Tick-Borne Disease Working Group Members and HHS Support Staff). The meeting started with a quorum.
Co-Chair Welcome, Recap of Meeting 12, and Agenda for Today
David Hughes Walker, MD, Professor, Department of Pathology, the Carmage and Martha Walls Distinguished University Chair in Tropical Diseases; Executive Director, UTMB Center for Biodefense and Emerging Infectious Diseases; Tick-Borne Disease Working Group Co-Chair, welcomed all meeting attendees and thanked all of the Tick-Borne Disease Working Group members for their efforts.
Leigh Ann Soltysiak, MS, Owner, Principal, Silverleaf Consulting, LLC; Adjunct Professor, Stevens Institute of Technology, Entrepreneurship Thinking; Tick-Borne Disease Working Group Co-Chair, welcomed everyone. Leigh Ann echoed David’s comments and noted that she looked forward to the Working Group members’ further collaborative efforts.
David briefly reviewed what the Working Group accomplished at Meeting 12, including the following:
- Finalized and voted on the template and outline for the Tick-Borne Disease Working Group’s Report to Congress;
- Finalized and voted on the recommendations proposed by the subcommittees of the Tick-Borne Disease Working Group;
- Placed the recommendation in the appropriate chapters; and
- Determined co-leads for each chapter.
Leigh Ann reviewed today’s meeting agenda, including public comments, an overview of the Working Group’s Mission and Vision Statements and Values; updates from the Public Comments Subcommittee, the Federal Inventory Subcommittee, and the writing groups responsible for developing the chapters of the Working Group’s Report to Congress; goals of the next meeting; and next steps. Leigh Ann noted that the Working Group acknowledges the public for their comments, which are heard and considered. She explained that the Working Group continues to review and consider ongoing public comments.
David explained that the goals of today’s meeting were to 1) hear updates from the Federal Inventory Subcommittee; 2) discuss and vote on the Federal Inventory Subcommittee’s recommendations; and 3) hear updates from other subcommittees and writing groups.
Leigh Ann briefly reviewed the timeline for developing and submitting the Working Group’s Report to Congress. She noted that the 2019-2020 Tick-Borne Disease Working Group began its work in July 2019 and conducted critical public meetings. She pointed out the placement of today’s meeting within the timeline and explained that the Working Group will discuss at the July virtual meeting their deliverable, which the Working Group will submit to Congress in November 2020.
Overview of the Working Group’s Mission Statement, Vision Statement, and Values
Jim reviewed the Working Group’s Mission Statement, as follows:
The Tick-Borne Disease Working Group’s mission, as mandated through the 21st Century Cures Act, is to provide expertise and to review all efforts within the Department of Health and Human Services related to all tick-borne diseases, to help ensure inter-agency coordination and minimize overlap, and to examine research priorities. As part of this mandate, and in order to provide expertise, we will ensure that the membership of the Working Group represents a diversity of scientific disciplines and views and is comprised of both Federal and non-Federal representatives, including patients, 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.
Finally, Jim gave an overview of the Working Group’s Core Values, the complete versions of which are provided below.
Respect: Everyone is valued
We respect all people, treating them and their diverse experiences and perspectives with dignity, courtesy, and openness, and ask only that those we encounter in this mission return the same favor to us. Differing viewpoints are encouraged, always, with the underlying assumption that inclusivity and diversity of minority views will only strengthen and improve the quality of our collective efforts in the long term.
Innovation: Shifting the paradigm, finding a better way
We strive to have an open mind and think out of the box. We keep what works and change what doesn’t. We will transform outdated paradigms when necessary, in order to improve the health and quality of life of every American.
Honesty and Integrity: Find the truth, tell the truth
We are honest, civil, and ethical in our conduct, speech, and interactions with our colleagues and collaborators. We expect our people to be humble, but not reticent, and to question the status quo whenever the data and the evidence support such questions, to not manipulate facts and data to a particular end or agenda, and to acknowledge and speak the truth where we find it.
Excellence: Quality, real-world evidence underlies decision-making
We seek out rigorous, evidence-based, data-driven, and human-centered insights and innovations—including physician and patient experiences—that we believe are essential for scientific and medical breakthroughs. We foster an environment of excellence that strives to achieve the highest ethical and professional standards, and which values the development of everyone’s skills, knowledge, and experience.
Compassion: Finding solutions to relieve suffering
We listen carefully with compassion and an open heart in order to find solutions which relieve the suffering of others. We promise to work tirelessly to serve the greater good until that goal is achieved.
Collaboration: Work with citizens and patients as partners
The best results and outcomes won’t be created behind closed doors, but will be co-created in the open with input of the American public working together with these core values as our guide. We actively listen to the patient experiences shared with us, respect the lived experiences of patients and their advocates, and learn from their experiences in our pursuit of objective truth. Across diverse audiences, we communicate effectively and collaborate extensively to identify shared goals and leverage resources for maximum public health impact.
Accountability: The buck stops here
We, as diligent stewards of the public trust and the funds provided by our fellow citizens, pledge to be transparent in all of our proceedings and to honor our commitments to ourselves and others, while taking full responsibility for our actions in service to American people.
Working Group Objectives
Leigh Ann then outlined the Working Group’s charge, 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 meeting; 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 and species of pathogenic organisms.
Public Comments
Eight members of the public provided comments.
Dorothy Leland: Dorothy spoke on behalf of Phyllis Mervine, whom she noted is the president and founder of LymeDisease.org. Dorothy remarked that the National Institutes of Health (NIH) had recently released treatment guidelines for Covid-19 that she felt were applicable to Lyme disease. Specifically, she highlighted three points from the guidelines: 1) No drug has been proven to be safe and effective for treating Covid-19; 2) There is insufficient clinical data to recommend for or against certain drugs for treatment; and therefore, 3) Treatment decisions should be determined by the patient and his or her health care provider. She asked that these statements be included in Lyme disease guidelines with a reminder that the recommendations in the guidelines should not be considered mandates.
Lucy Barnes: Lucy stated that, since their initial publication, the Infectious Diseases Society of America (IDSA) treatment guidelines for Lyme disease had been an obstacle for Lyme disease patients and their health care providers. She cited a 2008 quote from then Attorney General Richard Blumenthal regarding potential conflicts of interest amongst panel members involved in developing the guidelines. She stated that similar conflicts exist in the Working Group membership and asked the Working Group to rectify them.
Kathleen Wallace: Kathleen stated that she has multiple chemical sensitivity (MCS) resulting from tick-borne disease. She added that the current situation with Covid-19 highlights the challenges faced by people with MCS, as sanitation requirements to prevent the virus from spreading are unsuitable for them. Kathleen referenced a study conducted by Syracuse University’s Maxwell School of Citizenship and Public Affairs, which, she stated, found that 71% of Lyme disease patients have MCS. She asked for the Federal agencies to increase collaborative efforts to acknowledge and study MCS.
Enid Haller: Enid explained that she is from the Lyme Center of Martha’s Vineyard. She expressed concern about personal online attacks and the spread of misinformation that she said had been taking place amongst the Lyme disease advocacy community. She identified several individuals and organizations that she thought to be involved. Enid also highlighted the need for transparency and asked the Working Group to consider establishing a subcommittee devoted to conflicts of interest in Lyme disease.
Beth Carrison: Beth expressed gratitude to have been part of the Working Group’s Alpha-Gal Syndrome Subcommittee and urged the Working Group to push for an immediate national health alert for Alpha-gal Syndrome (AGS). She emphasized that many Covid-19 treatment options contain mammalian-derived ingredients, which, she noted, are potentially life threatening for patients with AGS, and few health care providers are aware of this risk. Moreover, she noted, providers in the current climate of Covid-19 do not have the time to research treatment options that are safe for AGS patients.
Andrea Jackson: Andrea stated that she is disabled from Lyme disease and went many years without a diagnosis. She expressed concern about potential conflicts of interest in the Working Group’s membership. She also offered criticism of guidance provided by Centers for Disease Control and Prevention (CDC) on Lyme disease testing. Andrea questioned the accuracy of available surveillance data and highlighted the lack of information available on non-tick transmission of Lyme disease. She commented that treatment of acute Lyme disease seems to be prioritized over treating patients with persistent illness.
Stephen Rich: Stephen stated that he is a professor of microbiology at the University of Massachusetts, where he runs the TickReportTM tick testing program. He remarked that, after many years of administering the service, he sees it as a valuable outreach tool to engage the public and raise awareness of tick-borne disease risk. Stephen questioned CDC’s recommendation that members of the public refrain from having ticks tested, noting that those who have been bitten will often do so anyway. He acknowledged that the quality of tick testing services offered by laboratories around the U.S. is mixed. However, he added, tick testing could become a truly valuable service if CDC revised its position and made recommendations for high-quality tick testing.
Susan Green: Susan commented that she has provided legislative counsel for NatCapLyme for the past 10 years. She described the persecution health care providers often face when treating patients with persistent Lyme disease, noting that she had provided expert testimony on this topic to the 2018 Tick-Borne Disease Working Group’s Access to Care Services and Support to Patients Subcommittee. Susan expressed concern about the interference of medical boards, insurance companies, elected officials, and pharmacists in the relationships between health care providers and their patients. She highlighted the importance of putting safeguards in place to protect decisions made by providers in consultation with their patients.
Public Comments Subcommittee Update
Leigh Ann, co-chair of the Public Comments Subcommittee, provided a brief update on behalf of the other two subcommittee co-chairs (see Appendix 3: Public Comments Subcommittee Members). Leigh Ann noted that the Working Group continues to receive public comments via email and at today’s meeting. She clarified that the public comments to be presented do not necessarily reflect the opinions of the Working Group members or HHS.
Leigh Ann explained that the Public Comments Subcommittee was established to review public comments and share information. The current Public Comments Subcommittee (2019-2020) shares the goals set by the inaugural Public Comments Subcommittee of the Tick-Borne Disease Working Group (2018-2019). Details of the public comments presented at the Tick-Borne Disease Working Group public meetings, Leigh Ann noted, are posted on the Tick-Borne Disease Working Group website (https://www.hhs.gov/ash/advisory-committees/tickbornedisease/index.html).
Leigh Ann reported that the Public Comments Subcommittee systematically reviewed public comments received from January 2019 to March 2020 via [email protected] or during the Working Group’s public meetings. To support the review process, the Public Comments Subcommittee conducted monthly conference calls from June 2019 to March 2020. The subcommittee categorized the comments received each month by key themes and shared the information with other subcommittees.
Leigh Ann further explained that before the Working Group’s March 2020 meeting, the subcommittees had already voted on their recommendations. She then highlighted the following topics covered in public comments that were received after the Working Group had voted on its recommendations.
- Tick-borne sepsis
- Tick-borne pathogen transmission (e.g., blood, tissue, and organ transplantation)
- Immune susceptibility related to COVID-19
- Oral tick preventatives
- Lyme disease and substance abuse
- Tick and duration of attachment
- Treatment of late-stage Lyme disease
- Treatment failure rates
- Real-world evidence and observational studies on treatment
Leigh Ann noted that the Public Comments Subcommittee will continue to review and consider public comments received today and after today’s meeting.
Federal Inventory Subcommittee Update
Subcommittee Co-Chair David introduced the public members of the Federal Inventory Subcommittee and the Federal agency consultants who attended some of the Federal Inventory Subcommittee meetings to answer questions (see Appendix 4: Federal Inventory Subcommittee members). David reported that the subcommittee
- Conducted three conference calls after the March 2020 Tick-Borne Diseases Working Group meeting (Meeting 12);
- Reviewed the inventory responses from seven Federal agencies, including the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the United States Department of Agriculture (USDA), the United States Department of Defense (DoD), the United States Department of Veterans Affairs (VA), and the Centers for Medicare and Medicaid Services (CMS);
- Proposed, discussed, and voted on possible recommendations for the Working Group to consider; and
- Decided which recommendations the subcommittee would present to the Working Group.
David then presented the following agency-specific recommendations, and the Working Group members discussed and voted on each recommendation.
Recommendation for VA
Recommend that the VA continue with Recommendation 8.4 from 2018 Working Group report, “Commence study of tick-borne disease incidence and prevalence of Veterans and eligible family members” and additionally
- Establish and update efforts on tracking and investigating the prevalence of Lyme and other tick-borne diseases; and
- Make educational modules available to practitioners.
Discussion of the Recommendation for VA
Eugene (Gene) Shapiro, MD, Professor of Pediatrics, Epidemiology, and Investigative Medicine, Yale University School of Medicine; Vice Chair for Research, Department of Pediatrics; Co-Director of Education, Yale Center for Clinical Investigation; Deputy Director, Yale PhD Program in Investigative Medicine, asked why Veterans and family members are singled out in this recommendation.
David responded that this recommendation is specifically for VA, which, David noted, did not provide sufficient responses to the inventory questions.
Vote on the Recommendation for VA
All members present at the meeting (13) voted yes to accept the recommendation. One member was absent.
Proposed Recommendation for DoD
Recommend that the DoD enhance communication and inter-agency collaboration to study Lyme disease and other tick-borne diseases.
Discussion of the Proposed Recommendation for DoD
Angel M. Davey, PhD, Program Manager, Tick-Borne Disease Research Program, Congressionally Directed Medical Research Programs, DoD, asked if the Working Group would like to be more prescriptive in the recommendation by providing more direction for DoD, and if the Federal Inventory Subcommittee had discussed that as a group.
David replied that the subcommittee did not discuss specifics.
Sam T. Donta, MD, Professor of Medicine (retired); Consultant, Infectious, explained that the subcommittee recognized that the Air Force, the Navy, Walter Reed National Military Medical Center, and other agencies within DoD are all doing a great job. The intent of this recommendation, he added, is to ensure cross talks within the department to minimize duplications and enhance collaborative efforts.
Dennis suggested revising “enhance communication and inter-agency collaboration” to “enhance inter-agency communication and collaboration.”
Revised Recommendation for DoD
Recommend that the DoD enhance inter-agency communication and collaboration to study Lyme disease and other tick-borne diseases.
Vote on the Revised Recommendation for DoD
All members present at the meeting (13) voted yes to accept the recommendation. One member was absent.
Recommendation for CDC
Recommend that if the CDC posts any Lyme treatment guidelines, that they include guidelines on persistent Lyme Disease.
Discussion of the Recommendation for CDC
Kevin R. Macaluso, PhD, MS, Locke Distinguished Chair, Chair of Microbiology and Immunology, College of Medicine, University of South Alabama, asked for clarification about the guidelines (e.g., whose guidelines might the recommendation pertain to).
David replied that it would be up to CDC to decide. He expressed his view that it is not the Tick-Borne Disease Working Group’s mandate to direct what CDC should post on its website.
Patricia (Pat) V. Smith, President, Lyme Disease Association, Inc., responded that the intent of this recommendation is to help patients with persistent Lyme diseases. She explained that while CDC currently does not post Lyme disease guidelines on its website, the agency does provide information on Lyme disease for health care providers. She added that CDC currently posts on its website guidelines for diagnosis and management of spotted fever group Rickettsia, and other information for health care providers (e.g., treatment for Colorado tick fever, Heartland virus, Powassan virus, and Bourbon virus). She noted that the inventory suggests that CDC also post information on treatment for Bartonella infection on its website. The purpose of this recommendation, she said, is to ensure all stages of Lyme disease are covered.
Leigh Ann asked if the intent of the recommendation is to address all tick-borne diseases. David responded that the recommendation is about Lyme disease only, and it does not cover other tick-borne diseases.
Pat reiterated that, based on the inventory response from CDC, the agency currently only posts guidelines on Rickettsioses. She further explained that her understanding is agencies tend to post guidelines for diseases with high disease burden. Because Lyme disease does carry high disease burden, she felt that it would be natural for CDC to post on its website treatment guidelines on Lyme disease. Data from FAIR Health, Pat said, indicate that a high percentage of individuals were not cured by a short course of doxycycline. The many patients with persistent symptoms of Lyme disease, she emphasized, need to be taken care of.
Vote on the Recommendation for CDC
Five members voted yes and three member voted no to accept the recommendation. Five members abstained from voting, and one member was absent.
Additional Discussion
Following the vote, Charles Benjamin (Ben) Beard, PhD, Deputy Director, Division of Vector-Borne Diseases, CDC, HHS; Associate Editor, Emerging Infectious Diseases, explained why he voted against this recommendation. He first clarified that CDC currently posts on its website only a simple table about early acute Lyme disease and early acute Rocky Mountain spotted fever. The reason for CDC to post information on early acute Rocky Mountain spotted fever, he explained, is because of its high fatality rate if not treated immediately; similarly CDC provides guidance for health care providers about treatment for early acute Lyme (including potential Lyme carditis) because it is less controversial and the information could make a big impact. He further explained that CDC does not post guidance on persistent Lyme disease because it is highly controversial, and that CDC does not post any entity or organization’s guideline on the topic. Instead, CDC leaves the treatment decision (e.g., how long to treat a patient) to clinicians. He noted that CDC does point out the caveats under the table. This recommendation, he explained, appears to treat the two stages of Lyme disease as the same, and that’s is why he, as a representative of CDC subject matter experts, voted against it.
Pat expressed her disappointment and frustration over the lack of progress in addressing persistent Lyme disease. Leigh Ann commented that the recommendation acknowledges persistent Lyme disease and evidence-based guidelines on persistent Lyme disease, which is not available yet.
In response to Leigh Ann’s comment, Ben noted that CDC does not generate data; rather it relies on data from NIH-sponsored clinical studies. Right now, he noted, data are lacking.
After learning that CDC does not post any guidelines on Lyme disease, Dennis noted that he would like to change his vote to “abstention.” He explained that NIH generates data and publishes the data in public domains, and other organizations (e.g., medical practices and professional societies) develop guidelines based on their own expertise. Pat protested that members could not change their votes after the vote had been conducted.
Sam Donta shared his view and explained why he proposed the recommendation. He noted that if CDC does not post any guidelines on treatment, it should not post the information on early acute Lyme disease either, which might be perceived of by some readers as guidelines. However, he added, if CDC is going to provide some information on Lyme disease, it needs to say something about people with persistent Lyme disease.
Recommendations for NIH
Recommendation 1: Recommend that the NIH create one or more study sections composed of members whose expertise is human clinical diseases and their pathogenesis and immunity not just basic science to evaluate applications focused on practical impact on human health related to tick-borne diseases.
Recommendation 2: Recommend that NIH receive additional funding which must be dedicated to study Lyme disease including persistent Lyme disease and other tick-borne diseases and conditions; and they encourage researchers to apply for these studies.
Discussion of Recommendation 1 for NIH
David explained the rationale for this recommendation based on his own experience as both an NIH grant reviewer and a grant applicant. Gene noted that some study sections have plenty of people with clinical experiences (e.g., the Clinical Research and Field Studies of Infectious Diseases Study Section). While agreeing with the recommendation in general, Gene pointed out that people with clinical expertise also need research expertise to review research proposals.
Dennis explained that NIH staff are aware of the concerns. He explained that the study sections are made of experts from various fields, including infectious diseases, genetics, epidemiology, microbiology, pharmacotherapy, and public health. These experts, he added, rotate on and off of the panels. Dennis noted that he could pass this recommendation along to the Center for Scientific Review (CSR), which organizes study sections.
Scott Palmer Commins, BS, MD, PhD, Associate Professor of Medicine & Pediatrics, University of North Carolina; Member, UNC Food Allergy Initiative, Thurston Research Center, shared that his team’s experience suggests that clinically oriented proposals tend to receive high scores (meaning a lower chance of getting funded) in basic science sections. He asked if the study sections Dennis mentioned encourage clinical research applications focusing on tick-borne diseases and conditions.
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, NIAID, NIH, explained that grants focusing on clinical questions and with clinical aims tend to be reviewed by clinical reviewers; grants with basic or translational aims are generally reviewed by basic or translational reviewers. He was not sure if CSR specifically tries to ensure that people with clinical expertise are on individual review panels. However, the question or recommendation can be brought forward to CSR, he said.
David commented that there are not enough people on panels that are disease-oriented or that address immunity to diseases.
Sam Perdue responded that it is a difficult call to make. He explained that clinical expertise and disease-oriented expertise tend to fall within the same pool of people. Because each study section covers many different diseases, CSR may not want people to argue which disease is more important. While acknowledging that the recommendation can go forward, Sam expressed his uncertainty about what CSR can practically do about the issue.
Vote on Recommendation 1 for NIH
All members present at the meeting (13) voted yes to accept the recommendation. One member was absent. While casting his vote, Dennis clarified that his “yes” vote means his team will forward the recommendation to CSR. Beto noted that he voted “yes” with the same caveat that Dennis mentioned.
Discussion of Recommendation 2 for NIH
None of the Working Group members raised questions.
Vote on Recommendation 2 for NIH
Ten members voted yes to accept the recommendation. Three members abstained from voting. One member was absent.
Recommendation for CMS
Recommend that CMS provides all information and data on Lyme disease and other tick-borne diseases and all applicable agency activities pertaining to these conditions, which may include but should not be limited to:
- Reimbursement costs for the diagnosis and treatment of beneficiaries with Lyme disease and other tick-borne diseases;
- Demonstration and pilot projects with Lyme disease and other tick-borne diseases as their focus; and
- Quality measure development and implementation related to Lyme disease and other tick-borne diseases.
Discussion of Recommendation for CMS
David explained that the Working Group received little information from CMS, and this recommendation essentially explains what CMS should provide in the inventory response.
Discussion of the Recommendation for CMS
None of the Working Group members raised questions.
Vote on the Recommendation for CMS
Twelve members voted yes to accept the recommendation. One member abstained from voting. One member was absent.
Discussion of Revisiting the Recommendation for CDC
Scott made a motion for the Working Group to reconsider the recommendation for CDC regarding posting guidelines on CDC’s website. Gene seconded the motion.
Scott explained that much of the discussion occurred after members of the Working Group had cast their votes, and that many members did not have the opportunity to discuss and hear the rationale for the recommendation as well as explanations from other Working Group members. After debating whether or not they could and should revisit the recommendation, the members decided to ask the DFO to provide guidance.
Alternate DFO Kaye Hayes, MPA, Executive Director, Presidential Advisory Council on HIV/AIDS, Principal Deputy Director, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, HHS, noted that she heard the discussion and motion. She suggested the Working Group table the topic while she double checks the rules.
Update on Chapter 3: Tick Biology, Ecology, and Control
Beto and Kevin, co-leads of the writing group for Chapter 3 of the Tick-Borne Disease Working Group Report to Congress, provided the following updates.
- The Chapter contains three recommendations.
- The writing team has completed about 75% of the work, and is considering tables and graphs to support the recommendations.
- There are no issues so far that would require minority responses.
The co-leads noted that they would continue working on the chapter, and they welcomed input and suggestions from other Working Group members on both the content and figures.
Discussion
Regarding chapter content and overall structure, David reminded the co-leads to focus on the recommendations while generating content for the chapter.
Beto explained that the writing team strives to provide context for the recommendations so that the reader would understand the rationales for the recommendations. To do so, he added, the team presents gaps and opportunities related to the recommendations.
Pat commented that at the last Working Group meeting, the Working Group talked about 1) using only materials that had been presented by the subcommittees; 2) if materials outside the subcommittee reports were used, then the materials would need to be voted on by the Working Group. Pat questioned why tables and graphs need to be voted on at the Working Group’s July 2020 meeting. She expressed her view that figures and tables from the subcommittees’ reports should not need to be voted again.
Leigh Ann clarified that the Working Group did not vote on the subcommittees’ reports, and that all figures and tables to be included in the Working Group’s final report to Congress will need to be voted on, even if they were included in the subcommittees’ reports.
Update on Chapter 4: Clinical Manifestations, Diagnosis, and Diagnostics
Sam Donta, co-lead of the writing group for Chapter 4, reported that the writing team had developed a draft based on the relevant information from the subcommittees’ reports, is making a good progress, and will continue to streamline the content. The team, he added, might include one table in the chapter.
Sam Donta shared that he has been communicating with the co-leads of other writing groups, and he suggested the writing groups post their chapters on the Working Group’s SharePoint site soon so that other Working Group members can provide input and avoid duplication. For the chapters, Sam Donta also suggested 1) keeping the background section brief so that the focus is on the chapter content, 2) reviewing the relevant recommendations included in the 2018 Tick-Borne Disease Working Group Report to Congress, and 3) providing updates on progresses made since the 2018 recommendations.
Discussion
After Sam Donta’s update, the Working Group members discussed again whether or not the Working Group should vote to accept the subcommittees’ reports and how the materials contained in the subcommittees’ reports should be used to develop the Working Group’s report. Different opinions were expressed. While Pat insisted that the Working Group should vote to accept the subcommittees’ reports, others pointed out that the Working Group could use the materials contained in the subcommittee reports as needed; however, to communicate more effectively with the target audience (Congress), the Working Group should summarize the relevant information, highlight the key messages (e.g., rationales for the recommendations), and vote and finalize the whole report at the end.
Leigh Ann agreed that the Working Group’s final report will not include everything from the subcommittees’ reports, and the Working Group will vote on the content of the final report, including text, graphs, and tables, at the Working Group’s July 2020 public meeting.
Update on Chapter 5: Causes, Pathogenesis, and Pathophysiology
Angel, co-lead of the writing group for Chapter 5, first reviewed the following three recommendations included in Chapter 5.
Recommendation 5.1: Provide HHS with resources necessary to fund basic science research and clinical research to investigate the pathology of the human immune response following tick bites (e.g., Alpha-gal Syndrome [AGS]).
Recommendation 5.2: Support the targeted funding of research to understand the role of persistence of bacteria and bacterial products in the pathogenesis and management of Lyme disease (e.g., antibiotic regimens and other therapeutics).
Recommendation 5.3: Support targeted funding opportunities for research to better inform the diagnosis, pathogenesis, and management of Lyme carditis.
Angel reported that the writing group has developed a draft, which includes background information, major issues and gaps, recommendations, and rationales. She explained that the writing group has discussed with Sam Donta regarding the rationales for the recommendations 5.2 and 5.3; and to avoid duplication, Chapter 5 will focus on pathogenesis and pathophysiology. The group, she said, is also considering including a table to cover all tick-borne diseases discussed by the Working Group; and there are no issues, so far, that would require minority responses.
Update on Chapter 6: Treatment
Dennis, co-lead of the writing group for Chapter 6, reported that the writing group has developed three drafts so far, and the content of Chapter 6 relies heavily on the subcommittees’ reports.
Co-lead Sam Donta added that Chapter 6 contains the following two recommendations.
Recommendation 6.1: Conduct laboratory, clinical, and field research to address gaps in our capacity to treat and prevent the broader range of tick-borne diseases, including particularly babesiosis, tick-borne relapsing fever, Powassan virus infection, and other low-incidence tick-borne diseases.
Recommendation 6.2: Encourage clinical trials on early and persistent Lyme disease.
Sam Donta explained that the writing group has extracted information from the subcommittees’ reports, will further streamline the content, and welcomes input from other Working Group members.
Update on Chapter 7: Clinician and Public Education, Patient Access to Care
Pat , co-lad of the writing group for Chapter 7, reported that the writing group for Chapter 7 has produced several drafts using the materials contained in the subcommittees’ reports, has completed about 75% of the work, and plans to use tables included in the subcommittees’ reports. The draft chapter, she explained, includes a background section and the following five recommendations.
Recommendation 7.1: Recommend Federal government websites and educational materials and seminars for clinicians, the public, and public health departments, which discuss Lyme disease, provide information that the state of the science relating to persistent symptoms associated with Lyme disease, is limited, emerging, and unsettled; and increase public awareness that there are divergent views on diagnosis and treatment. Consider that shared medical decision-making may be appropriate in some circumstances.
Recommendation 7.2: Fund and support a directive for CDC (or other appropriate HHS OPDIV or agency) to develop (either directly or through an approved federal contract) a multi-leveled and nationwide curriculum on Lyme disease for clinicians-in-training as well as continuing medical education modules to increase the pool of qualified and practicing clinicians. Provide funding for the U.S. military to participate in this nationwide training and education on Lyme disease and other tick-borne diseases and conditions. This curriculum should be introduced and encouraged at the State level. The final curriculum shall incorporate feedback from patients, clinicians, and research scientists with expertise/experience that represents diverse scientific and clinical experiences on the full spectrum of Lyme disease and other tick-borne diseases/conditions.
Recommendation 7.3: Fund efforts across the U.S. to expand/require medical education to inform emergency, primary care, and other healthcare providers and to raise clinician and public awareness of rickettsial (including Rocky Mountain spotted fever), ehrlichial, and anaplasmal diseases.
Recommendation 7.4: Fund efforts across the U.S. to expand/require medical education to inform emergency, primary care, and other healthcare providers and to raise clinician and public awareness of babesiosis, tick-borne relapsing fever, emerging tick-borne viral infections, and other low-incidence tick-borne diseases.
Recommendation 7.5: Generate broad awareness of Alpha-gal Syndrome through the following two mechanisms:
- Provide funding/support/resources necessary to create a National Tick-Borne Alpha-gal Syndrome Alert that is focused on awareness, prevention, and education regarding tick associated Alpha-gal Syndrome and that targets key stakeholder groups.
- Label foods/beverages, medications and medical products, cosmetics, etc. containing mammalian-derived components for the safety of consumers with Alpha-gal Syndrome.
Update on Chapter 8: Epidemiology and Surveillance
Ben, co-lead of the writing group for Chapter 8, reported that Chapter 8 contains the following three recommendations.
Recommendation 8.1: Fund prospective acute febrile illness studies to understand burden of tick-borne diseases, including rickettsial, ehrlichial, and anaplasmal pathogens.
Recommendation 8.2: Recommend that CDC work with Council of State and Territorial Epidemiologists, CSTE, to streamline the surveillance process and reduce the burden on clinicians and public health departments by permitting direct laboratory reporting of positive cases.
Recommendation 8.3: Further evaluation of non-tick bite transmission of Lyme disease, for example maternal-fetal transmission.
Ben explained that similar to other chapters, Chapter 8 also includes background information, major challenges, and recommendations. Specifically, the background section builds upon the 2018 Tick-Borne Disease Working Group Report to Congress and highlights progresses that have been made; the Major Challenges section discusses tick-borne diseases in general; and the Recommendations section uses materials from the corresponding subcommittee reports to provide rationales for the specific recommendations. The writing process, Ben noted, is going well, and the writing group anticipates there would be at least one minority response.
Discussion of and Vote on Revisiting the Recommendation for CDC
After referencing Robert’s Rules of Order, Kaye addressed the previously tabled request to revisit the recommendation for CDC. She stated that the request for revisiting the recommendation came from a Working Group member who initially abstained from voting but later wished to vote yes to support the recommendation. She then explained that the rules do not indicate that the Working Group cannot revisit the recommendation. She cautioned, however, that the Working Group should not keep repeating this practice, which happened in the last Working Group public meeting (Meeting 12); and she advised that the Working Group consider developing guidelines in the future to prevent this practice from happening again.
Vote on Revisiting the Recommendation for CDC
Working Group members discussed and voted to determine if they should revote the recommendation for CDC. Seven members voted no and six members voted yes to revisit the recommendation. One member was absent. Based on the voting result, the Working Group decided not to revisit the recommendation for CDC.
Review of Meeting 13 and Next Steps
Leigh Ann noted that the Working Group will discuss and vote on the text, tables, and figures of all chapters at the July public meeting. She reminded the Working Group members of the timeline and the report submission date (November 2020). She encouraged the Working Group members to continue their collaboration while developing the chapters, and she reiterated the suggestions made by Working Group members during the meeting, including Sam Donta’s suggestions on the background section of each chapter and on referencing the 2018 recommendations.
David concluded that the Working Group has accomplished what the Working Group set to accomplish today. He emphasized the importance of the Working Group’s work and recommendations, and noted that the Working Group still has a lot of work to do.
Adjournment
The meeting was adjourned at 12:00 pm Eastern.
Appendix 1: Tick-Borne Disease Working Group Members
In alphabetical order:
Co-Chair
Leigh Ann Soltysiak, MS, Owner, Principal, Silverleaf Consulting, LLC; Adjunct Professor, Stevens Institute of Technology, Entrepreneurship Thinking (Present)
Co-Chair
David Hughes Walker, MD, Professor, Department of Pathology, the Carmage and Martha Walls Distinguished University Chair in Tropical Diseases; Executive Director, UTMB Center for Biodefense and Emerging Infectious Diseases (Present)
Charles Benjamin (Ben) Beard, PhD, Deputy Director, Division of Vector-Borne Diseases, Centers for Disease Control and Prevention, HHS; 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 (Absent) – CAPT Scott J. Cooper, MMSc, PA-C, Senior Technical Advisor and Lead Officer for Medicare Hospital Health and Safety Regulations, Centers for Medicare and Medicaid Services, U.S. Department of health and Human Services (Alternate present)
Scott Palmer Commins, BS, MD, PhD, Associate Professor of Medicine & Pediatrics University of North Carolina; Member, UNC Food Allergy Initiative, Thurston Research Center (Present)
Angel M. Davey, PhD, Program Manager, Tick-Borne Disease Research Program, Congressionally Directed Medical Research Programs, U.S. Department of Defense (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 (Present) - Samuel (Sam) S. Perdue, PhD, Section Chief, Basic Sciences and Program Officer, Rickettsial and Related Diseases, Bacteriology and Mycology Branch, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, U.S. Department of Health and Human Services (Alternate present)
Sam T. Donta, MD, Professor of Medicine (retired); Consultant, Infectious Diseases (Present)
CAPT Estella Jones, DVM, Deputy Director, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, U.S. Department of Health and Human Services (Absent) – 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 (Alternate present)
Kevin R. Macaluso, PhD, MS, Locke Distinguished Chair, Chair of Microbiology and Immunology, College of Medicine, University of South Alabama (Present)
Adalberto (Beto) Pérez de León, MS, PhD, Director, Knipling-Bushland U.S. Livestock Insects Research Laboratory, United States Department of Agriculture—Agricultural Research Service (Present)
Eugene David Shapiro, MD, Professor of Pediatrics, Epidemiology, and Investigative Medicine, Yale University School of Medicine; Vice Chair for Research, Department of Pediatrics; Co-Director of Education, Yale Center for Clinical Investigation; Deputy Director, Yale PhD Program in Investigative Medicine (Present)
Patricia V. Smith, President, Lyme Disease Association, Inc. (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 (Absent) – Shahla Jilani, Deputy Chief Medical Officer, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services (Alternate absent)
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
Kaye Hayes, MPA, Alternate Designated Federal Officer, Tick-Borne Disease Working Group; Executive Director, Presidential Advisory Council on HIV/AIDS, Principal Deputy Director, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services
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
Allison Petkoff, ORISE Fellow, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services
Debbie Seem, RN, MPH, Health Policy Advisor, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services
Appendix 3: Public Comment Subcommittee Members
In alphabetical order:
Subcommittee Co-Chairs
Scott Palmer Commins, MD, PhD, Physician and Scientist, University of North Carolina Health Care
Angel M. Davey, PhD, Program Manager, Tick-Borne Disease Research Program, Congressionally Directed Medical Research Programs, U.S. Department of Defense
Leigh Ann Soltysiak, MS, Owner, Silverleaf Consulting, LLC
Appendix 4: Federal Inventory Subcommittee Members
In alphabetical order:
Chair
David Hughes Walker, MD, Professor, Department of Pathology, the Carmage and Martha Walls Distinguished University Chair in Tropical Diseases; Executive Director, UTMB Center for Biodefense and Emerging Infectious Diseases
Sam Donta, MD, Professor of Medicine (retired); Consultant, Infectious Diseases
Pat Smith, President, Lyme Disease Association, Inc.
Consultants
Charles Benjamin (Ben) Beard, PhD, Deputy Director, Division of Vector-Borne Diseases, Centers for Disease Control and Prevention, HHS; Associate Editor, Emerging Infectious Diseases, Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Services – Sue Visser, DrPH, MS, Associate Director for Policy, Division of Vector-Borne Diseases, Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Services (Alternate)
Dennis Dixon, PhD, Chief, Bacteriology and Mycology Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, U.S. Department of Health and Human Services – 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)
Adalberto (Beto) Perez de Leon, MS, PhD, Director, Knipling-Bushland U.S. Livestock Insects Research Laboratory, United States Department of Agriculture—Agricultural Research Service
Appendix 5: Writing Groups for the 2020 Report to Congress
- Executive Summary—Leigh Ann Soltysiak and David Hughes Walker
- Introduction to Tick-Borne Diseases: Where We Are Now—Leigh Ann Soltysiak and David Hughes Walker
- Chapter 1: Background—Leigh Ann Soltysiak and David Hughes Walker
- Chapter 2: Methods—Leigh Ann Soltysiak and David Hughes Walker
- Chapter 3: Tick Biology, Ecology, and Control—Adalberto (Beto) Perez de Leon and Kevin R. Macaluso
- Chapter 4: Clinical Manifestations, Diagnosis, and Diagnostics—Sam Donta and Todd Myers
- Chapter 5: Causes, Pathogenesis, and Pathophysiology—Scott Palmer Commins and Angel M. Davey
- Chapter 6: Treatment—Dennis Dixon and Sam Donta
- Chapter 7: Clinician and Public Education, Patient Access to Care—Scott Cooper and Pat Smith
- Chapter 8: Epidemiology and Surveillance—Charles Benjamin (Ben) Beard and Eugene David Shapiro
- Chapter 9: Looking Forward—Leigh Ann Soltysiak and David Hughes Walker
- Chapter 10: Conclusion—Leigh Ann Soltysiak and David Hughes Walker
