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, 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), called the meeting to order and welcomed all meeting attendees. Jim then conducted roll call (see Appendix 1: Tick-Borne Disease Working Group Members). The meeting started with a quorum.
Co-Chair Welcome, Status Update, 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 reminded them of the importance of the meeting.
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. She provided a brief summary of what had taken place during Meeting 13 and highlighted the work that has been accomplished since then, including the following:
- Chapter co-leads (Appendix 3: Writing Groups for the 2020 Report to the HHS Secretary and Congress) compiled their chapters
- Working Group members reviewed the chapters and provided feedback
Leigh Ann asked members to keep in mind the report audience—specifically, members of Congress—as they worked through the chapter material.
Leigh Ann acknowledged the passing of Lyme disease patient and advocate Dr. Neil Spector.
Leigh Ann outlined the meeting agenda, noting that review of the report content will begin with Chapter 3. She added that Chapters 1 and 2, along with the Conclusion and Table of Contents, will be reviewed and discussed last.
David explained that the purpose of the meeting is to discuss member feedback on the chapters and vote on or approve any proposed changes or edits that arise from the discussion.
Leigh Ann presented the timeline for the 2020 Report to the HHS Secretary and Congress, stating that there will be additional meetings in August and September, with the final deliverable due by December 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.
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.
Process Review
Jim reminded members of their charge for the day: to review chapter content, discuss member feedback, and resolve comments. He explained that the outcome of the meeting would be a second draft to be presented at Meeting 15 in August 2020.
Jim explained that during today’s meeting, the Working Group co-chairs would lead the group through the chapter material, comment by comment and edit by edit, in order to come to a consensus about content. He added that the Working Group will decide as a group what to keep, delete, and revise.
Jim emphasized the amount of work to be done and encouraged members to work collaboratively and follow the agenda as closely as possible.
Finally, Jim urged members to vote constructively, reminding them that an abstention functions as a vote for the prevailing side.
Vector-Borne Strategy Update
Charles Benjamin (Ben) Beard, PhD, Deputy Director, Division of Vector-Borne Diseases, Centers for Disease Control and Prevention, HHS; Associate Editor, Emerging Infectious Diseases, provided an update on the Federal Vector-Borne Strategy.
Ben explained that in 2019, CDC led an interdepartmental effort to develop the National Public Health Framework for Prevention and Control of Vector-Borne Diseases in Humans, which outlines Federal activities necessary to detect, prevent, and control vector-borne diseases. He added that the framework serves to lay the foundation for the development and execution of a full National Strategy, as authorized by the Kay Hagan Tick Act. The strategy, he continued, will require collaboration within the Federal government along with outside stakeholders and partners.
Ben announced that HHS had recently cleared the framework, noting that the next step would be interdepartmental clearance, followed by public distribution of the framework.
Public Comments
Leigh Ann noted that the Working Group was pleased to reserve the time slot for public comments, as they had done in previous public meetings. Leigh Ann briefly explained the process and reminded all of the public members that they are welcome to provide written comments online (https://www.hhs.gov/ash/advisory-committees/tickbornedisease/contact-us/index.html) or via email ([email protected]).
Five members of the public provided comments over the phone.
Enid Haller: Enid, founder of the Lyme Center of Martha’s Vineyard, noted that many Lyme disease advocates do not know where the funding allocated through the Kay Hagan Tick Act would go. She shared that the advocates are concerned that the same organizations or individual doctors would receive the funding and new voices might be excluded. She commented there has been little progress in research in terms of testing and treatment for Lyme disease. She shared her belief that Lyme disease was created intentionally, and she stated that Lyme advocates want a Congressional hearing to reveal the truth and to have responsible individuals prosecuted.
Elizabeth Maloney: Elizabeth stated that she was speaking with the support of the board of directors of the International Lyme and Associated Diseases Society (ILADS). She noted that she coauthored the ILADS Treatment Guideline for Lyme disease, and she encouraged those who have not read the guideline to read it. Elizabeth commented on the controversy around persistent Lyme disease. She indicated that the development of some guidelines on Lyme disease lacks true accountability, and she noted that institutionalized bias appears to be widespread. Citing the Johns Hopkins Study of Lyme Disease Immunology and Clinical Events (SLICE), Elizabeth expressed her disagreement with Ben Beard’s comment (at the last Tick-Borne Disease Working Group meeting) on the differences between early acute Lyme disease and persistent manifestations of Lyme disease. To help clinicians better diagnose and manage patients with persistent manifestations of Lyme disease, Elizabeth called to 1) restore the National Guidelines Clearinghouse and accept only guidelines that meet the National Academy of Medicine’s standards for guideline development; 2) reopen and encourage the use of PubMed Commons so that minority opinions can be heard; and 3) ensure the CDC curriculum development team represents the broad scientific perspectives on persistent Lyme disease.
Beth Carrison: Beth, co-founder of Tick-Borne Conditions United, highlighted health disparities affecting minority populations. Beth pointed out that the 2018 Tick-Borne Disease Working Group Report (Chapter 5) recognized that identifying the classic findings in individuals with dark skinned pigmentation may be challenging, resulting in delays or even failure to diagnose Lyme disease and other tick-borne diseases. Citing a survey conducted by Tick-Borne Conditions United and the 2018 Tick-Borne Disease Working Group Report to Congress, Beth noted that minorities are under-recognized and under-represented in tick-borne disease studies. She urged the 2019-2020 Tick-Borne Disease Working Group to address the needs of all patients. Additionally, Beth wanted to know if the identified need has been incorporated in the 2020 report to Congress; if not, how and where in the report the Working Group plans to address the topic. Specifically, she asked how the Training, Education, Access to Care, and Reimbursement chapter will address education, awareness, and participation in communities most impacted, and how each area of need will work towards increasing outreach to patients and their providers in low-income and minority communities.
Alex Moresco: Alex stated that she is a 27-year old tick-borne illness patient and advocate. She shared that she wrote her master’s thesis on the 2018 Tick-Borne Disease Working Group Report to Congress, and that she has built an online community of 20,000 patients. She noted that her goal today was to reinforce her community’s support for the Tick-Borne Disease Working Group’s work, especially when it comes to patients’ access to care. Alex shared that based on the stories she had heard from thousands of patients from all 50 sates, access to adequate medical care is a common issue that has led to long-term ailments. Alex stressed the importance of developing accurate testing tools, educating health care providers, finding a middle ground for insurance coverage, and reducing the stigma around tick-borne illness. Alex commented that there has been increased awareness of tick-borne illness since the inception of the Tick-Borne Disease Working Group. She noted that the Tick-Borne Disease Working Group’s findings are critical for the Lyme disease community to receive adequate care, and she urged HHS to continue to invest resources to the Tick-Borne Disease Working Group.
Wendy Adams: Wendy of the Bay Area Lyme Foundation commented that medical information and physician training on Lyme and other tick-borne diseases is inadequate and the inadequacy has caused fatalities. She noted that some simple facts such as the definition of an erythema migrans are often misunderstood and miscommunicated by the medical and scientific community and state health departments. Wendy explained that “bull’s eye” or “target rash” are often used synonymously with erythema migrans, even though erythema migrans is not required to have central clearing. Given that an erythema migrans presents with central clearing in only about 20% of cases where a rash is present, Wendy noted that it means only one in six Lyme cases will have a rash with a target appearance. Wendy shared that almost a dozen cases of acute Lyme disease fatalities have been reported recently due to misdiagnosis and delayed treatment. She emphasized that diagnosing patients early is the best way to protect people from tick-borne infections. Wendy noted that the lack of reliable tests underscores the critical importance of educating health care providers about Lyme disease because inadequate training is causing fatalities that could and should have been avoided by timely antibiotic treatment.
Discussion of the Subcommittee Report Process
Before the group began their review of chapter feedback, Sam Donta, MD, Professor of Medicine (retired); Consultant, Infectious Diseases, stated that he would like to comment on the Working Group’s process as it relates to the subcommittee reports. He described how the subcommittee reports were prepared and reviewed by the Working Group in January. He explained that it was his understanding that only new content—or content that was not included in the subcommittee reports—would be the focus of today’s meeting. He stated that he was prepared to make a motion to that effect.
David replied that the Working Group did not formally approve the subcommittee reports. He stated that they were the basis for the Working Group’s recommendations, which have been approved by vote. He added that while the reports were valuable, their content was not discussed by the Working Group as a whole. David commented that the purpose of today’s meeting is to determine if the chapters appropriately justify the recommendations and prepare Congress to read and understand them.
Jim responded that David’s statements reflect his understanding of the process.
Sam D. explained that most of the language in the chapters he had prepared was taken from the subcommittee reports. He proposed that in the future the Working Group thoroughly discuss the subcommittee reports and possibly vote on them.
David responded that the language taken from the subcommittee reports should appropriately support the recommendations; however, he added that this does not mean all subcommittee report language can automatically be included in the Working Group’s final report.
Dennis M. Dixon, PhD, Chief, Bacteriology and Mycology Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, HHS commented that Tick-Borne Disease Working Group members are official Federal Advisory Committee Act (FACA) members whose role is to advise the government, whereas subcommittee members do not have this designation. He added that the reports prepared by non-FACA members are used as a basis for the final FACA report.
Dennis requested comment from Kaye Hayes, MPA, Alternate DFO, 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, HHS.
Kaye agreed with Dennis and added that the subcommittees provide insight, advice, and council to the Working Group, but all content must ultimately be reviewed and voted upon by the full advisory committee.
Pat expressed concern about the process. She stated that it was her understanding from the March meeting that chapter co-leads were to use material from the subcommittee reports in order to formulate their chapters and that any new material would require approval from the Working Group.
Scott (Coop) J. Cooper, MMSc, PA-C, Senior Technical Advisor and Lead Officer for Medicare Hospital Health and Safety Regulations, Centers for Medicare and Medicaid Services, HHS, commented that he did not recall deliberations by Working Group members on the subcommittee reports but there were opportunities to ask questions and discuss different issues that arose.
Jim expressed appreciation for the work that went into the subcommittee reports; however, he added that Kaye’s description of the process is correct.
Sam D. conveyed concern about changing the language in the subcommittee reports because it came from subject matter experts. He agreed with Coop that deliberations should have taken place when the reports were submitted. He noted that, if needed, he would make a proposal that the language in the chapters remain unchanged by today’s deliberations.
David stated that the subcommittee reports stand as final products authored by the subcommittee members. He specified that the Working Group’s current responsibility is to present the recommendations to Congress using material that cogently supports them. He added that it is not necessary to use the exact language from the subcommittee reports.
When asked if he would like to make a motion, Sam D. replied that he would not.
Review of Chapter 3: Tick Biology, Ecology, and Control
Led by Leigh Ann and David, the Working Group reviewed each suggested revision and comment in “Chapter 3: Tick Biology, Ecology, and Control.” The member who provided feedback was given the opportunity to explain his or her edit or comment. Next, responses to the feedback were provided by writing co-leads Kevin R. Macaluso, PhD, MS, Locke Distinguished Chair, Chair of Microbiology and Immunology, College of Medicine, University of South Alabama, and Adalberto (Beto) Pérez de León, MS, PhD, Director, Knipling-Bushland U.S. Livestock Insects Research Laboratory, United States Department of Agriculture—Agricultural Research Service. Finally, all members were given the opportunity to continue the discussion, reach consensus on how to proceed, and/or make motions and vote on proposed content changes.
The following is a summary of the Working Group’s discussion of Chapter 3.
Comment 1 by David Walker
The Working Group decided to disregard the comment because it related to a recommendation that had already been voted on and accepted by the group.
Deletions and revisions (p. 1) by Sam Donta
The Working Group discussed the deletions and revisions by Sam D. on page 1.
Sam D. explained that his deletions and revision of the content were intended to make the report more concise.
Kevin responded that he would prefer to keep the text as it was originally written, stating that it was intentionally broad in order to be both encompassing and concise.
Beto suggested starting the paragraph with Sam D.’s revised text, followed by the two sentences that originally began the paragraph. He noted that this arrangement would bring into focus the global nature of tick-borne diseases while highlighting the public health threat in the United States.
Beto then made a motion to implement the suggestion he had just made.
During the discussion period, 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, HHS, agreed with Kevin to begin the paragraph with the original broader statements.
Beto suggested changing “tick-borne diseases” to “tick-borne infectious diseases” and added it to his motion.
Patricia (Pat) V. Smith, President, Lyme Disease Association, Inc., seconded the motion.
Ben stated that he did not object to the original wording, in part because it recognizes that not all tick-borne diseases are infectious, for example Alpha-gal Syndrome and southern tick-associated rash illness (STARI).
Sam D. clarified that by making the deletion, he was expecting the content to be moved to the overall report background section. He added that he would accept whatever decision was made.
Todd commented that he agreed with Beto’s suggestion but that he did not want to limit tick-borne diseases to only pathogens that are transmitted from wildlife to humans when new diseases regularly are being discovered.
Leigh Ann reminded members to keep members of Congress in mind when writing content. She suggested avoiding the use of jargon or overly complex language to ensure the reader can get through the report without having to stop and look up terminology and concepts.
Vote
Thirteen members voted yes to starting the paragraph with Sam D.’s revised text, followed by the two sentences that originally began the paragraph. The vote also included replacing “tick-borne diseases” with “tick-borne infectious diseases” in the new first sentence. One member voted no. The motion passed.
Before discussing the next comment, the group acknowledged that David had had left an empty comment box on the first page of the chapter. David stated that there was no issue there and prompted the group to move on.
Comment 2 by Leigh Ann Soltysiak
Members discussed Leigh Ann’s suggestion to enhance Figure 1 (Discovery of Tickborne Pathogens as Causes of Human Disease by Year, 1909-1959 and 1960-2016)—related to the increase in tick-borne pathogens over time—by adding a visual or graphic.
Leigh Ann stated that a picture might provide more impact and clarity.
Kevin suggested simplifying the figure legend and establishing more clearly that there have been nearly twice as many pathogens discovered in the past 50 years as compared to those discovered prior to 1970.
Beto suggested that CDC might have a more updated version of the timeline.
Ben responded by identifying the source of the timeline and added that there is a more recent version that shows discoveries from 1960 to 2020. He described some of the modifications that have been made to the updated timeline, including the replacement of “Rickettsia philippi” with “Rickettsia 364D.” Ben also explained why there have been so many new pathogens discovered in recent decades. Specifically, he stated that there has been a major emergence of ticks and reservoirs, combined with better diagnostic tools to discriminate the different agents. He concluded by stating that he would provide the updated timeline to the writing co-leads.
Beto noted that when they receive the new graphic from Ben, he and Kevin will confer with David and Leigh Ann to ensure Leigh Ann’s comment is addressed.
Kevin made a motion to replace the existing figure with an updated depiction of the discoveries from 1960 to 2016 and include a legend that describes the discoveries made between 1900 and 1959 and highlights the more recent identification of tick-borne pathogens. Leigh Ann seconded the motion.
David made a process clarification for the overall meeting, stating that it is not necessary to wordsmith exact language for the revisions that are being decided at the meeting, but rather to capture the intent of the revisions.
Vote
Fourteen members voted yes to replacing the existing figure with an updated depiction of the discoveries from 1960 to 2016 and include a legend that describes the discoveries made between 1900 and 1959 and highlights the more recent identification of tick-borne pathogens. The motion passed.
Comment 3 by David Walker
David, Beto, and Kevin discussed David’s comment about the taxonomic status of Rickettsia phillippi and Rickettsia strain 264D.
Beto pointed out the reference he had cited in the manuscript, which clarifies the nomenclature.
David stated that the updated taxonomies can be found in the International Journal of Systematic Microbiology. He then prompted the group to move on.
Deletions (p. 2) by Sam Donta
Sam D. stated that his deleted text had been moved to the beginning of the chapter and had already been discussed earlier in the meeting.
Beto agreed.
Comment 4 by David Walker
Referring to his comment in the chapter that Figure 2 is illegible, David stated the issue will likely be addressed.
Ben responded that he would provide the high-resolution file.
Comment 5 by Leigh Ann Soltysiak
Referring to her comment about spacing between lines, Leigh Ann stated that voting is likely not needed on minor editorial issues.
There was general consensus that this type of voting is not needed.
Comment 6 by Leigh Ann Soltysiak
Leigh Ann explained that a graphic might help the reader understand the concept being described in the manuscript [specifically, “shifting the onus of tick control away from just individuals to a partnership or team approach…”]. She asked if a graphic could be rendered or if all graphics had to be sourced.
Beto also asked whether or not concepts could be generated.
Leigh Ann commented that the decision about the graphic does not need to be decided at the meeting and that Kevin and Beto can review the comment and decide.
Comment 7 by David Walker
David stated that the high-resolution file is also needed for Figure 3.
Comment 8 by David Walker
In explaining his comment, David emphasized the need for content on lone star ticks in Chapter 3 because they are associated with at least five different diseases. He then made a motion to add a section on lone star ticks and diseases.
Ben expressed appreciation for the comment and noted that, while CDC is moving forward with its national tick surveillance problem, it lacks “snapshot” data on where Amblyomma americanum (lone star tick) populations were in the past versus where they are today. However, he agreed that a section on their expansion is needed.
Kevin responded that content on lone star ticks can be included. He then seconded David’s motion.
Leigh Ann asked if there was an updated map for Figure 4 (“Previous efforts to collate national, county scale data”).
Ben replied that there is a CDC map with 2018 data. He noted that he would work with Beto and Kevin to update the information.
Vote
Fourteen members voted yes to adding a section on lone star ticks and diseases. The motion passed.
Comment 9 by Angel Davey
Angel M. Davey, PhD, Program Manager, Tick-Borne Disease Research Program, Congressionally Directed Medical Research Programs, U.S. Department of Defense, explained that it is important to link the identification of hazards to human health with tick surveillance, including measurement of risk. She noted that Chapter 8 covers incidence of disease; however, she added, the minority response highlights the gap in linking risk with human disease.
Beto asked for clarification about what her intended revision would be in Chapter 3.
Angel responded that no deletions are needed; however, she emphasized that the concepts of tick surveillance in Chapter 3 should be linked to the concepts of disease incidence in Chapter 8.
Leigh Ann suggested making that connection in the Background section.
Angel agreed.
David cautioned the group about including too much detail in the Background section.
Leigh Ann suggested revisiting Angel’s proposed edits during the discussion of the Background section.
Angel agreed.
Comment 10 by Leigh Ann Soltysiak
Leigh Ann explained that her comment was editorial in nature and pointed out the redundant use of the word “scale.”
Beto and Kevin agreed to revise the content accordingly.
Comment 11 by Leigh Ann Soltysiak
Leigh Ann explained that her comment (11) was similar to the previous one (10), prompting the group to move on.
Comment 12 by Angel Davey
Angel suggested adding the Department of Defense (DoD) and the U.D. Department of Agriculture (USDA) to the introduction of the recommendations in Chapter 3.
David commented that, according to Working Group’s Federal inventory, USDA had not conducted much research.
Beto clarified that a significant amount of research on ticks and tick-borne diseases is done within specific in-house branches of USDA. He added that the data call did not elicit responses that would outline such research.
Angel made a motion to specifically call out DoD in the introduction to the Chapter 3 recommendations.
Beto asked to include USDA in the motion as well.
Angel clarified that her motion was to specifically call out DoD and USDA in the introduction to the Chapter 3 recommendations.
Pat seconded Angel’s motion.
Vote
Fourteen members voted yes to specifically calling out DoD and USDA in the introduction to the Chapter 3 recommendations. The motion passed.
Comment 13 by Angel Davey
The group agreed that because Angel’s comment about rodent-targeted control efforts pertained to a recommendation, no changes would be made.
Comment by 14 David Walker
The group agreed that because David’s comment about inclusion of lone star ticks and their associated diseases pertained to a recommendation, no changes would be made.
Comment 15 by Leigh Ann Soltysiak
Leigh Ann explained her comment about rephrasing text, noting that her intention is to improve the flow and help the reader understand how the different entities described in the text work together.
Kevin responded that he and Beto would work together to revise the content for review by the Working Group at the August meeting.
Comment 16 by Angel Davey
Angel explained that DoD does tick surveillance and integrated pest management (IPM) for the benefit of the war fighter. She, therefore, suggested specifically calling out DoD in the content that justifies and explains Recommendation 3.3.
Beto noted that USDA collaborates with DoD in those efforts.
Ben suggested addressing the comment by adding “(such as DoD and USDA)” after the word “Federal.”
Beto replied that he and Kevin would follow Ben’s suggestion to address Angel’s comment.
The Working Group concluded its discussion of Chapter 3.
Review of Chapter 4: Clinical Manifestations, Diagnosis, and Diagnostics
Led by Leigh Ann and David, the Working Group reviewed each suggested revision and comment in “Chapter 4: Clinical Manifestations, Diagnosis, and Diagnostics.” The member who provided feedback was given the opportunity to explain his or her edit or comment. Next, responses to the feedback were provided by writing co-leads Sam T. Donta, MD, Professor of Medicine (retired); Consultant, Infectious Diseases; and 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. Finally, all members were given the opportunity to continue the discussion, reach consensus on how to proceed, and/or make motions and vote on proposed content changes.
The following is a summary of the Working Group’s discussion of Chapter 4.
Comment 1 by David Walker
The Working Group decided to disregard this comment because it related to a recommendation, which had already been voted on and accepted by the group.
Deletion (p. 1) by Sam Donta and Comment 2 by Leigh Ann Soltysiak
Sam D. explained that he deleted the Background heading and content because he did not think the wording was necessary. He then made a motion to remove the content in question.
Leith Jason States, MD, MPH (FMF), Deputy Chief Medical Officer, Office of the Assistant Secretary for Health, HHS, seconded the motion.
The group discussed consistency of headings across chapters. Leigh Ann suggested retitling the major headings of each chapter, so they are all the same.
Ben pointed out that the report writers will help with formatting as part of the editorial process.
Leith withdrew his second, and Sam D. withdrew his motion.
Comment 3 by Leigh Ann Soltysiak
Referencing Leigh Ann’s comment, Sam D. agreed to add a comma between “signs” and “symptoms.”
Comment 4 by Leigh Ann Soltysiak
Referencing Leigh Ann’s comment, Sam D. agreed to revise the text to avoid redundant language.
Comment 5 by Angel Davey
Angel prompted the group to skip her comment and move on to the next one.
Comment 6 by Eugene Shapiro
Eugene (Gene) 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, explained that citing mouse models as justification for processes related to human diseases may not be sufficient as mice are a natural reservoir for Borrelia burgdorferi.
David made a motion to remove the first 11 lines of the paragraph in question and start the next sentence with “The possibility probability the effects of persisting Lyme [disease] are a source of ongoing symptoms in patients…”
Gene seconded the motion.
David agreed with Gene’s statement and added that mice are the normal hosts of B. burgdorferi and what happens with them is not indicative of what happens with humans. He underscored that there is uncertainty about whether or not persistent organisms are the source of ongoing symptoms. He added that the possibility of persistent infection remains and needs to be determined.
Sam D. agreed that there is uncertainty about the source of persistent symptoms; however, he highlighted persistent infection as a prominent possibility. He acknowledged that animal models have certain limitations but can be useful to further understand certain phenomena. He added that some of the animal models referenced are non-human primate systems that demonstrate metabolically active, persistent spirochetes.
Sam D. disagreed with removing the content, stating that it provides rationale for the recommendation to support basic research.
David suggested that there is an overemphasis on persistent infection when other possibilities should also be considered.
Leigh Ann stated that the basis of the content is the lack of definitive tests, and mouse models allow for the exploration of causes of persistent symptoms.
Gene elaborated on the limitations of mouse models.
Dennis suggested reordering the content, so that it starts by stating the issue and ends with the studies that demonstrate potential explanations.
Pat disagreed with removing the animal model content, stating that animal models are an important step in helping patients get treatment. She emphasized the need for more research—both animal and human.
Sam D. stated that Lyme arthritis is well-studied using animal models; therefore, animal research should not be discounted in other areas of Lyme disease. He argued that the content in question is not definitive; rather, it highlights the probability of persistent infection.
Beto commented that animal models are useful and important to biomedical research and including them in this chapter is appropriate as an accounting of the research that has been conducted in the area of B. burgdorferi persistence. He proposed stating clearly what the animal data demonstrate while acknowledging the challenge of extrapolating the data to humans. He then suggested using language such as the following: “Reports suggest that this may be the case in humans” and “In a non-human primate model, it was documented that persistent spirochetes are metabolically active. These findings based on research with animal models indicate…”
David reiterated that there is an overemphasis in the paragraph on persistent infection as a potential cause of persisting symptoms.
Dennis again suggested reordering the content. He proposed starting the paragraph with the following statement: “We [do not] know the cause of persistent symptoms post-treatment.” This, he suggested, would be followed by a list of the causes, including those that are non-infectious. Dennis also highlighted the importance of doing additional research to understand cause of persistent symptoms.
Sam D. agreed that it is important to highlight to Congress and HHS the need for more research. He also agreed to rearranging the content as Dennis suggested.
Todd and Angel agreed with Dennis’s suggestion for revising the paragraph in question. Angel proposed— whether the content is rearranged or not—including a concise statement that additional study is needed to determine if there is a link to human conditions or to ongoing Lyme disease symptoms.
Sam D. agreed to the suggestions by Dennis, Todd, and Angel.
Leigh Ann asked Sam D. if there are any sources that include evidence-based medicine or compiled information from multiple clinicians.
Sam D. responded that there is some big data available and added that the members of the Clinical Aspects of Lyme Disease Subcommittee represented significant clinical experience.
Throughout the discussion, members also commented multiple times on whether or not to change the language in the original text from “probably” to “possibly” and from “probable” to “possible.”
Leigh Ann reminded the group that there is a motion on the table and asked for any other discussion.
Ben stated that he would like to explain his vote before he casts it. He elaborated that he would be comfortable with the original content as long as it states that the research findings support a hypothesis that the effects of persistent infection could be a source of ongoing symptoms. He recommended more objectivity in the way the content is presented.
When Pat asked for clarification, Ben commented that he generally agreed with Dennis and Angel’s suggestions and highlighted that further research is needed.
Pat suggested that the motion on the floor be retracted, so another motion to revise the content could be made.
Todd noted that he would not be comfortable with removing the animal model content entirely and that he would like to have the opportunity to work with Sam D. to revise the content according to the suggestions made thus far.
David restated his motion and did not retract it.
At this point in the meeting, there was confusion about the wording of the original motion and about a revision that had been made to the text prior to the meeting. It was clarified that the original motion was to delete the first 11 lines of the paragraph in question and use the word “possibly”—rather than “likely” or “probably”—when describing persistent organisms as a source of persistent symptoms. There was disagreement among members about the use of these words and exact phrasing in the chapter.
Gene asked David if he would consider changing or removing his motion to allow for revision of the language.
David did not agree to changing the motion.
Sam D. commented that there will be another opportunity after the vote to make another motion to change the material.
Pat expressed concern about taking Sam D.’s proposed approach and asked for clarification about the process from alternate DFO Kaye Hayes.
Kaye stated that the motion on the floor should not be predicated on a future motion. She clarified that another motion can be made immediately after the current vote takes place; however, it will be a separate and distinct motion. She emphasized that all decisions are made collectively by the Tick-Borne Disease Working Group.
Pat expressed her distrust of the process.
Kaye continued by stating that, if there is no friendly amendment, then the original motion is still on the floor. After the vote, she added, another member can make a motion and the body can decide how to proceed.
David reiterated his motion as follows: Remove the first 11 lines of the paragraph in question and begin the paragraph with the following phrase: “There is the possibility that the effects of persisting symptoms are a source of …”
The group clarified that voting “yes” will support David’s motion and voting “no” means there will be no change to the content.
Vote
Five members voted yes to removing the first 11 lines of the paragraph in question and beginning the paragraph with the following phrase: “There is the possibility that the effects of persisting symptoms are a source of …” Nine members voted no. The motion failed.
Continued discussion of comment 6 by Eugene Shapiro
Members continued to discuss how to modify the content so that it is more acceptable to those with concerns.
Sam D. and Todd agreed to work together to implement the suggestions made by Ben and Angel (see previous section).
David emphasized the need to state that research is needed to determine whether or not persistent symptoms are caused by persistent infection.
Sam D. proposed moving the content later in the chapter or to Chapter 5 on pathogenesis.
Kevin suggested keeping the content where it is, but revising it to be more concise and succinct, so that it is consistent with the previous chapter. He suggested the following verbiage: “Studies utilizing animal models of infection (REF) support the hypothesis that the effects of persisting organisms are a source of ongoing symptoms in patients with unresolved Lyme disease symptoms. Thus, the pathogenesis of these ongoing symptoms remains to be defined. Possible explanations include 1) direct effects of spirochete antigens on host functions, 2) persisting antigens resulting in immune or autoimmune reactions, 3) a combination of both possibilities, or 4) as-yet-to-be-discovered pathophysiologic events.”
Sam D. agreed with Kevin’s suggestion and proposed “tabling” the content.
Leigh Ann remarked that Kevin’s verbiage will be captured in the chapter notes for the authors to review.
Comment 7 by David Walker
David prompted the group to skip his comment about “expression of host genes” and move on to the next one.
Comment 8 by David Walker
David explained that his comment is a request to change the word “likely” to “possibly.”
Sam D. stated that he preferred Kevin’s proposed change (See Chapter 4: “Continued discussion of comment 6 by Eugene Shapiro”).
David made a motion to change the word “likely” to “possibly” in the content being discussed.
Ben suggested waiting until the August meeting to take vote in order to give Sam D. and Todd the opportunity to revise the paragraph based on the suggestions made so far.
David withdrew his motion.
Comment 9 by Pat Smith
Pat prompted the group to skip her comment about the Feng/Zhang citation and move on to the next one.
Comment 10 by David Walker
David suggested revising the following text to say “pathogenesis” instead of “pathophysiology” and explained his reasoning: “The pathogenesis of these ongoing symptoms remains to be defined.”
Sam D. agreed to make the change.
Comment 11 by Leigh Ann Soltysiak
Leigh Ann remarked that the authors can consider her comment about parasitic infections when they revise the chapter. She then prompted the group to move on to the next comment.
Comment 12 by David Walker
David suggested that, in the paragraph before Table 1 (“Chronic Lyme and Lyme-like illness”), the term “persistent Lyme disease” be replaced by “late Lyme disease and PTLDS” [post-treatment Lyme disease syndrome].
Sam D. replied that “persistent Lyme disease” had already been approved by the Working Group in all of the recommendations, adding that it was meant to be a descriptive term, unrelated to cause. He also stated that the 2018 Working Group had discussed PTLDS at length and decided against using the term.
David clarified that he is proposing to change the text as opposed to the recommendations.
Gene and Sam D. discussed whether or not the term “persistent Lyme disease” relates to cause. Gene suggested instead using the term “patients with persistent symptoms.”
David made a motion to change the term “persistent Lyme disease” to “late Lyme disease and PTLDS.”
Gene seconded the motion.
Sam D. commented that those terms are too expansive to use throughout the report.
Ben suggested using “persistent symptoms associated with Lyme disease” because it acknowledges that the pathogenesis is unknown.
Coop proposed “patients with persistent clinical manifestations associated with Lyme disease.”
Leigh Ann questioned using a new term that is not already recognized by the Lyme disease community, adding that “persistent Lyme disease” is frequently used by stakeholders.
Ben replied that the terminology varies depending on the stakeholder group and suggested using language that is objective and accommodating to all stakeholders.
David agreed with Ben’s suggestion to replace “persistent Lyme disease” with “persistent symptoms associated with Lyme disease.”
Sam D. stated that, in the context of the paragraph under discussion, he would be willing to change the phrase to “persistent symptoms of Lyme disease.”
Ben, David, and Gene emphasized that it should “persistent symptoms associated with Lyme disease.”
The group discussed the difference in meaning between the two phrases, after which Sam D. agreed to revise the text using Ben’s suggestion.
David revised his motion, as follows: Replace “persistent Lyme disease” with “persistent symptoms associated with Lyme disease.”
Vote
Fourteen members voted yes to replacing “persistent Lyme disease” with “persistent symptoms associated with Lyme disease.” The motion passed.
15-minute break
After a 15-minute break, Jim conducted roll call. The meeting continued with a quorum.
Comment 13 by Leigh Ann Soltysiak
Leigh Ann explained that her comment about the color treatment in Table 1 could be resolved by the support writers and prompted the group to move on to the next comment.
Comment 14 by Leigh Ann Soltysiak
Leigh Ann explained that it is unclear if “Table 1. Chronic and Lyme-like illnesses” is intended to address both Lyme disease and chronic Lyme disease. She suggested that the authors consider her comment. She then prompted the Working Group to move on to the next comment.
Comments 15 and 16 by David Walker
Referencing two of his comments for “Table 1. Chronic and Lyme-like illnesses,” David explained that the terms “memory” and “lymph nodes” do not represent symptoms. He added that some of the terms in the table are symptoms while others are signs. He then proposed renaming the table “Clinical symptoms associated with Lyme disease and Lyme-like illnesses” and addressing the inconsistent terminology, specifically “memory” and “lymph nodes.”
Sam D. explained the origin of the table and clarified that the reason he included it was to show that there are symptoms associated with persistent Lyme disease and that they are clinically difficult to differentiate from certain other chronic illnesses. He agreed to revise the terms “memory” and “lymph nodes,” so they are consistent and represent signs or symptoms, as appropriate.
Leigh Ann expressed confusion about the proposed title change, noting that it implies that the table includes both acute and chronic Lyme disease symptoms.
Sam D. agreed.
David and Sam D. discussed the incidence of chronic Lyme disease in states with low reported cases of acute Lyme disease. They also discussed signs and symptoms associated with acute Lyme disease versus chronic Lyme disease.
Sam D. stated that he would be willing to replace “chronic Lyme disease” with “persistent Lyme disease” in the table. However, he added that he thought David’s suggested revision was too long. He concluded by stating that he would revise the terminology as previously stated.
Comment 17 by Leigh Ann Soltysiak
Referencing her comment, Leigh Ann asked if there is an operational definition of Gulf War Syndrome. She suggested adding a footnote where it is referenced to help the reader understand the term.
Ben suggested using plain language for terms such as “myalgia,” “arthralgia,” and “parasthesias.”
Sam D. agreed to make Ben’s revision and stated that he would add a citation or footnote that explains Gulf War Syndrome.
Comment 18 by Eugene Shapiro
Gene explained his comment by stating that there is uncertainty about ongoing infection and antibody response.
Sam D. responded that the statements in question are supported by the rodent and nonhuman primate studies. He added that the text acknowledges the uncertainty about serologic test results and persistent Lyme disease.
Gene stated that the antibody criterion referenced in the text would lead the reader to conclude that individuals with chronic fatigue syndrome and fibromyalgia also have Lyme disease.
Sam D. disagreed and clarified the intended meaning of the text. He commented that the existing assays are not sensitive enough and that this is the main point of the paragraph in question.
Gene suggested that the point was not made clearly in the text. He also disagreed with Sam D. about how serologic test results can be interpreted.
Pat expressed frustration that the discussion continues to be about terminology to describe persistent illness. She emphasized that Lyme disease patients remain ill regardless of the words used to describe them. She urged members to move the conversation along.
David and Sam D. discussed immune response and the interpretation of negative serologic results and in both early and late disease. They disagreed on the conclusions that can be drawn about these factors.
David, Sam D., and Gene talked about existing controlled trials, their limitations, and the difficulty of initiating new ones.
Sam D. made a motion to accept the language as originally written.
Pat seconded the motion.
Ben justified the way he intended to vote, stating that he agreed with the first sentence of the paragraph in question but that he would like to see the rest of the paragraph modified.
Vote
Eight members voted yes to keeping the language as originally written. Five members voted no. One member abstained. The motion passed.
Comments 19 through 24 by David Walker and Leigh Ann Soltysiak
Comments 20 through 25 pertained to the paragraph the Working Group had just voted to accept (“Existing laboratory tests…”). Therefore, members moved on to grouping of comments related to the paragraph that followed.
Comments 25 and 26 by Eugene Shapiro and David Walker
Gene explained that he disagreed with the statement that “patients with persistent Lyme disease frequently have limited IgG responses to B. burgdorferi antigens when tested by a Western blot (Donta, 2012), indicating an inadequate or ineffective host immune response to the infection.”
Sam D. briefly justified the statement and made a motion to accept it as written.
Ben described what he had understood from talking to physicians who treat patients with Lyme arthritis, which was that antibiotic treatment beyond two to three months is often ineffective.
Sam D. responded that there is a small subset of patients with Lyme arthritis who continue to have symptoms following antibiotic treatment and that the reasons are not fully understood. He clarified that the paragraph in question is about Lyme disease patients, rather than the patients whom Ben was referring to.
Sam D. reaffirmed his motion.
David and Gene asked Sam D. questions about how the diagnosis of persistent Lyme disease is established.
Sam D. explained that it is a clinical diagnosis based on the best science available. He underscored that, without definitive means for clinical decision-making, clinicians must use their judgment to evaluate antibody response in response to different treatment regimens.
David suggested that a limited IgG response to B. burgdorferi antigens could be interpreted as an indicator that there is no B. burgdorferi antigen stimulation of the immune response.
David and Sam D. agreed that a controlled study with a placebo would be especially informative. Sam D. noted that Chapter 6 highlights the need for such trials.
David suggested replacing “indicating an inadequate response” in the text with “possibly suggesting an inadequate response.”
Sam D. agreed to the change, and the Working Group moved on to the next group of comments.
Comments 27 and 28 by Leigh Ann Soltysiak and David Walker
David stated that IgM activities are non-specific in many diseases and are not limited to patients with chronic Lyme disease. He added that there are false positive IgM responses in rickettsial diseases and other diseases.
Sam D. clarified that the content refers to patients who have already shown an IgM response during early disease and continue to have it during later stages.
David suggested clarifying the language in the text, stating that it currently did not reflect Sam D.’s intended meaning.
Sam D. responded that the clarification could be added; however, the text also refers to patients who had not been previously diagnosed with Lyme disease and did not recall having a tick bite. He acknowledged that false positive serologic results do occur but emphasized that he did not think an automatic “false positive” designation is appropriate when other clinical information is available for consideration in the diagnosis.
David agreed that taking an individualized approach to diagnosing each patient is important. He suggested, however, that the text should describe the overall situation since the ultimate audience is Congress.
Sam D. stated that his goal was not to detract from existing tests but to highlight the need for better tests.
Leigh Ann reminded Sam D. to consider her comment (28) during his revision of the chapter.
Comment 29 by Leigh Ann Soltysiak
Leigh Ann suggested that the content in question could be better organized to improve reader understanding.
Sam D. responded that he would address her suggestion during his revision of the chapter.
Comment 30 by Eugene Shapiro
Gene agreed with David’s earlier comments about false positive IgM responses. He added that numerous studies have demonstrated that patients can have a positive IgM response many years after they have been treated for and cured of Lyme disease. He then made a motion to delete the paragraph in question [starting with “Another issue associated…”].
Sam D. responded that he is aware of the citation Gene had referenced in his comment and added that other publications indicate that IgM persistence can be associated with patients who have ongoing symptoms.
Gene commented that people with ongoing infection can have a positive IgM response, but he clarified that the issue arises when there is a positive IgM response and a negative IgG. He reiterated his motion to remove the paragraph.
Sam D. said again that he did not think an automatic “false positive” designation is appropriate when other clinical information is available for consideration in the diagnosis. He highlighted that clinicians have limited tools to make a definitive diagnosis. He added that he would be open to revising the content but not to deleting it.
Gene stated that the text should better portray the uncertainty of the issue at hand.
Leith agreed with Sam D. that the content should be revised rather than deleted.
Ben suggested tempering the language in question to reflect the uncertainty particularly when it comes to IgM responses, which he noted, are cross-reactive with all diseases.
Sam D. responded that the content is about the 23 and 39 proteins specifically, which he stated, are closely associated with B. burgdorferi and do not cross-react. He expressed his willingness to work with Todd to revise the content.
Gene withdrew his motion.
Kevin pointed out that there are citations for some sections but not others. He asked that Sam D. and Todd consistently provide citations throughout the chapter.
David stated that he had intended to second Gene’s motion; however, Leigh Ann explained that it had been withdrawn.
Sam D. made a motion to accept the paragraph as originally written with the following change to the last sentence: Replace “…are likely caused by an ongoing infection” with “are maybe caused by an ongoing infection.”
Pat seconded the motion.
Beto asked that Sam D. provide a citation for the revised statement, to which Sam D. agreed.
Pat stated that real-world evidence—including patient data as well as generated in routine clinical practice—should be admissible in the report.
Vote
Fourteen members voted yes to accepting the paragraph as originally written with the following change to the last sentence: Replace “…are likely caused by an ongoing infection” with “are maybe caused by an ongoing B. burgdorferi infection” and adding citations. The motion passed.
Comment 31 by Leigh Ann Soltysiak
The Working Group skipped this comment because it pertained to the paragraph members had just voted to accept (see Comment 30 by Eugene Shapiro, Vote).
Comment 32 by David Walker
Regarding his comment, David asked how proteins can be unique if they have not been defined.
Sam D. responded that they are defined as not existing in normal patients or patients with other diseases, for example chronic fatigue syndrome or multiple sclerosis. He added that the sentence could be rephrased.
David suggested the word “unique” be removed.
Sam D. agreed to make the change.
Comment 33 by David Walker
David said the content (“may represent host response”) was acceptable as written and prompted the group to move on to the next comment.
Comment 34 by David Walker
David explained that he was concerned about the quality of the references cited for the following statement: “Of note, use of certain antibiotic regimens were followed by reversal of these defects.” He made a motion to remove the sentence.
Gene seconded the motion.
Sam D. responded that he could provide more evidence for the statement and added that the statement could be tempered or modified.
David emphasized that the statement is too definitive given the limited data available to support it.
Sam D. suggested starting the sentence with the following phrase: “In a limited number of patients, there appear to be…”
David did not agree to the suggestion if there is no available reference for controlled studies.
Sam D. and David discussed the challenges of conducting controlled studies involving patients with persistent Lyme disease.
David reiterated his motion to delete the sentence.
Sam D. suggested using the phrase “limited observational studies.”
Pat made a motion to table the discussion until Working Group members have an opportunity to review the references.
Sam D. seconded Pat’s motion.
Vote
Ten members voted yes to tabling the discussion until Working Group members have an opportunity to review the references. Three members voted no. One member abstained. The vote passed.
Comment 35 by Eugene Shapiro
Given that his comment was related to the recently tabled discussion, Gene prompted the Working Group to move on to the next comment.
Revision of content (p. 4) by Sam Donta
Sam D. explained that his revision to the paragraph preceding the section on Alpha-gal Syndrome was intended to enhance accuracy. He prompted the Working Group to move on to the next comment.
Comment 36 by David Walker
David explained that his comment highlights a sentence in the chapter that describes his hypothesis about children in the southern United States with a large degree of exposure to lone start ticks that contain an organism with low pathogenicity.
Comment 37 by Leigh Ann Soltysiak
The Working Group skipped this comment.
Comment 38 by Pat Smith
Pat asked that a citation be included to support the Rocky Mountain spotted fever (R. rickettsii) fatality rate (23%) provided in the text.
David explained that the rate represents the number of patients, historically, who died before antibiotics were available.
Pat remarked that the text portrays the information in a way that makes it seem like a current-day statistic.
Leigh Ann asked if a source could be provided for the current rate.
Pat responded that she would provide the references for two statistics: 1.4% and 2-4%.
David commented that the rates described by Pat may not be accurate because, he stated, the studies include people with nonpathogenic rickettsia and do not reflect the high fatality rates I states such as Arizona.
Ben noted that CDC has quality data on the case fatality rate for Rocky Mountain spotted fever that he could provide. He added that the fatality rates for spotted fever group have declined steeply.
Ben and Pat agreed that the text should reflect the fatality rates discussed in J. McQuiston’s CDC paper on rickettsial diseases and include the appropriate citation.
Sam D. responded that he and Todd would work with David, Pat, and Ben to revise the text.
Comment 39 by Pat Smith
Pat explained that her comment was another request for a citation for the Rocky Mountain spotted fever mortality rate (20%).
Sam D. noted that the content was redundant and suggested that it be removed.
Comment 40 by Pat Smith
Pat requested that a citation be included for the tick-borne relapsing fever content under “Emerging Tick-Borne Pathogens.”
Sam D. suggested that Ben and Gene provide a citation.
Revision by Ben Beard
Ben stated that he had made a comment that did not appear in the version of Chapter 4 under review. He explained that the following statement regarding acute rickettsial diseases is incorrect: “There are currently no pathogen-specific tests for these diseases.” He added that there is an FDA-cleared RT PCR direct test that is specific for R. rickettsii and noted that he can provide the reference.
David asked whether or not the test is commercially available.
Ben responded that it had been published and FDA cleared but that he was uncertain about its commercial availability.
Ben suggested that the text be revised to say that there are limited tests available, and that the reference be included.
David recommended the following phrasing: “Currently only limited pathogen-specific tests available for these diseases.”
Return to comments 36 and 37 by David Walker and Leigh Ann Soltysiak (respectively)
Pat asked if comments 36 and 37 had been resolved. She highlighted the need to include scientific citations for any hypotheses that are included.
David explained where the data came from and added that the hypothesis is generally accepted as a potential explanation for why there is a high proportion of healthy individuals with antibodies for non-pathogenic rickettsiae.
Kevin commented that are two published studies on nonhuman primates that he could provide to Sam D. and Todd.
David described studies his lab had done as well.
Ben stated that he would also send CDC’s Morbidity and Mortality Weekly Report and surveillance summaries on the topic as well.
Pat agreed to keep the text as long as citations were added.
The Working Group concluded its discussion of Chapter 4.
Plan for the Remainder of the Meeting
As the meeting was running over schedule, Gene and Sam D. inquired about whether the discussion would end at the scheduled adjournment time in the meeting agenda or continue into the evening. Sam D. suggested scheduling an additional meeting before Meeting 15 in August.
Leigh Ann and David explained that there would not be time to schedule another meeting due to the requirements set by Federal Advisory Committee Act. They prompted members to move forward and try to cover as much material as possible.
Review of Chapter 5: Causes, Pathogenesis, and Pathophysiology
Led by Leigh Ann and David, the Working Group reviewed each suggested revision and comment in “Chapter 5: Causes, Pathogenesis, and Pathophysiology.” The member who provided feedback was given the opportunity to explain his or her edit or comment. Next, responses to the feedback were provided by writing co-leads Scott Palmer Commins, BS, MD, PhD, Associate Professor of Medicine & Pediatrics, University of North Carolina; Member, UNC Food Allergy Initiative, Thurston Research Center; and Angel M. Davey, PhD, Program Manager, Tick-Borne Disease Research Program, Congressionally Directed Medical Research Programs, DoD. Finally, all members were given the opportunity to continue the discussion, reach consensus on how to proceed, and/or make motions and vote on proposed content changes.
The following is a summary of the Working Group’s discussion of Chapter 5.
Comment by David Walker
[The comment was not included in the document that was visible to the meeting audience; therefore, it is not numbered.]
David began by commenting that the following statement should be revised for accuracy: “Diagnostic tools with accuracy and specificity are lacking.” He added that the tests are specific; however, they are not sensitive enough.
Angel responded that she would be willing to replace the word “specificity” with “sensitivity.”
Comment 1 by David Walker
David explained that a reference is needed to support the following statement: “Tick-borne infection may weaken a patient’s immune system.”
Angel replied that the statement reflects concerns within the patient community and added that she was not aware of a supporting reference.
Sam D. suggested deleting the sentence or rewording it to be more accurate. He clarified that there are animal models that support the statement but no human studies.
Angel and Scott stated that they would be willing to delete the sentence.
Sam D. proposed the following verbiage to replace the original sentence: “Although there are animal studies that indicate the immune system could be affected, there is no evidence that humans have any immune system abnormalities.”
Leigh Ann suggested starting the section by saying that there are no human studies currently available, although this may not be true across all tick-borne diseases.
David and Gene commented that the concept is not worth including if there is no evidence to support it.
David made a motion to remove the following statement: “Tick-borne infection may weaken a patient’s immune system.”
Gene seconded the motion.
Pat suggested that the group consider the following article: Garg, K., Meriläinen, L., Franz, O. Pirttinen, H., Quevedo-Diaz, M., Croucher, S., and Gilbert, L. (2018). Evaluating polymicrobial immune responses in patients suffering from tick-borne diseases. Science Reports 8(15932). https://doi.org/10.1038/s41598-018-34393-9
David commented that the reference is likely a review and asked what the data are.
Angel reiterated that the purpose of the content is to reflect what patients are concerned about. She added that she would need to read the article before deciding whether or not to reference it.
Scott suggested that he and Angel consider the article, then make a determination about whether to delete the statement or include it with the reference.
David agreed to Scott’s suggestion.
Comment by David Walker
[The comment was not included in the document that was visible to the meeting audience; therefore, it is not numbered.]
David stated that the word “likelihood” should be replaced with “possibility” in the following sentence: “Although the cause of these long-term symptoms is still under investigation, the results of these and other studies support the likelihood that they are attributed to persistent infection.” He added that the statement has not been proven.
Sam D. responded that there is enough evidence in animal model research to use the word “likely.”
David commented that it is not possible to measure long-term symptoms in animals. He added that the statement would be true if it were about animals.
Sam D. suggested rephrasing the statement using the following language: ““Although the cause of these long-term symptoms in patients is still under investigation, the result of these and other studies support the likelihood that they’re attributed to persistent infection.”
Sam D. made a motion to keep the word “likelihood” in the sentence.
Gene stated that he would prefer to use the word “possibility.”
Sam D. pointed out that the sentence that follows the statement in question provides the necessary qualification.
Leigh Ann noted that the group had already covered the issue of likelihood versus possibility during their discussion of Chapter 4
David prompted the group to move on to the next comment.
Comment 2 by David Walker
Angel accepted David’s suggestion to replace “ingests” with “stimulates” in the following sentence: “The tick releases salivary factors into the skin of the host and ingests host-derived cytokines, growth factors, complement components, antibodies, and other potentially bioactive molecules.”
Comments 3 and 4 by David Walker
David stated that the word “influx” should be replaced with “effect” in the following sentence: “Also poorly understood are the immune defense strategies used by ticks to counter the influx of vertebrate host factors and microorganisms and the effect of this influx on vector and pathogen fitness.”
Sam D. clarified that “influx” is a published term that was used by an expert who had presented to his subcommittee.
Sam D., David, Angel, and Beto discussed the terms “influx,” “input,” and “fitness” and whether or not the text conveyed the intended meaning.
Scott suggested replacing the word “input” with “interaction.”
Beto proposed replacing the word “fitness” with “pathogen infectivity.” He urged the chapter co-leads to review the language to ensure the intended meaning is clearly conveyed.
Comment by David Walker
[The comment was not included in the document that was visible to the meeting audience; therefore, it is not numbered.]
David suggested deleting the word “passive” in the following sentence: “The passive surveillance of human-biting ticks and associated pathogens is already being conducted in several labs to provide customized, individual risk assessment of pathogen exposure.”
Leigh Ann responded that any comments made after the Working Group’s May deadline—comments that were not currently visible on the screen—will need to be discussed another time. David agreed. The group moved on to the next comment.
Comment 5 by Eugene Shapiro
The group agreed that because this comment pertained to a recommendation (5.2), no changes would be made.
Comments 6 through 10 by Leigh Ann Soltysiak, Eugene Shapiro, and David Walker
Gene explained that the topics of mouse models and persistence had already been discussed. He prompted the group to move on to the next comment.
Comment 11 by Eugene Shapiro
Gene commented that there was not enough evidence to link the statements he had highlighted (starting with “Persisting B. burgdorferi appear to be antibiotic-tolerant…”) to human disease.
Sam D. responded that the content was an attempt to understand one of the possibilities of why there are apparent failures in certain antibiotic regimens. He described new studies that have been conducted in this area.
Gene made a motion to delete the highlighted content (starting with “Persisting B. burgdorferi appear to be antibiotic-tolerant…”).
David seconded Gene’s motion.
Pat stated that she disagreed with the deletion.
Sam D. explained that the content is intended to outline areas of current and possible future research.
Angel reminded the group that the content relates to Recommendation 5.2, which calls for support of research “to understand the role of persistence of bacteria and bacterial products in the pathogenesis and management of Lyme disease (for example, antibiotic regimens and other therapeutics).” She suggested adding the following statement to the content in question: “More work needs to be done to see if this has a relationship [or relevance] to human disease.”
Gene and David agreed with Angel’s suggestion.
Beto suggested moving the following citation so that it follows immediately after the first sentence in the paragraph: Sharma, Brown, Matluck, Hu, & Lewis, 2015.
Dennis proposed closing the paragraph with the following sentence: “This emphasizes the need for further research in this area.”
David and Gene withdrew the motion to delete the highlighted content (starting with “Persisting B. burgdorferi appear to be antibiotic-tolerant…”).
The Working Group concluded its discussion of Chapter 5.
Review of Chapter 6: Treatment
Led by Leigh Ann and David, the Working Group reviewed each suggested revision and comment in “Chapter 6: Treatment.” The member who provided feedback was given the opportunity to explain his or her edit or comment. Next, responses to the feedback were provided by writing co-leads Dennis M. Dixon, PhD, Chief, Bacteriology and Mycology Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, HHS; and Sam T. Donta, MD, Professor of Medicine (retired); Consultant, Infectious Diseases. Finally, all members were given the opportunity to continue the discussion, reach consensus on how to proceed, and/or make motions and vote on proposed content changes.
The following is a summary of the Working Group’s discussion of Chapter 6.
Comment 1 by Leigh Ann Soltysiak
Leigh Ann explained that her comment about headings relates to editorial consistency, which will be resolved by the support writers. She prompted the group to move on to the next comment.
Deletions (p.1) by Sam Donta
The group briefly discussed Sam D.’s deletion of the first two paragraphs. No one objected, and the group moved on to the next comment.
Comment 2 by Leigh Ann Soltysiak
Leigh Ann explained that her comment was intended to help a lay reader understand treatment of multiple simultaneous tick-borne infections. No one objected, and the group moved on to the next comment.
Comments 3 and 4 by David Walker and Pat Smith
David explained that the following statement may not be accurate because it refers to all available tests for tick-borne diseases in general: “Current diagnostic tests have limitations, which include low specificity and low sensitivity.”
Sam D. replied that the text is intended to highlight the broad need for more sensitive and more specific diagnostic tests.
Gene suggested removing the terms “sensitive” and “specific” and simply stating that better diagnostic tests are needed.
David agreed.
Sam D. agreed to Gene’s suggestion.
Referencing her comment (4), Pat suggested stating that testing issues can arise at all stages of Lyme disease and including references to Schutzer and Sigal about the formation of antibody complexes.
Gene commented that the studies are older and only apply to early stages of disease.
Pat replied that testing issues often stand in the way of people receiving a diagnosis.
Sam D. agreed to consider Pat’s suggestion during the revision of the chapter.
Comment 5 by Eugene Shapiro
Gene explained that the topic of his comment for Table 6.1 (related to persistent Lyme disease) had already been thoroughly discussed.
Sam D. pointed out that Recommendation 6.1 uses the term “persistent Lyme disease.”
Gene prompted the group to move on to the next comment.
Comment 6 by Ben Beard
Ben stated that the topic of his comment for Table 6.1 (also related to persistent Lyme disease) had already been addressed. He prompted the group to move on to the next comment.
Comment 7 by Leigh Ann Soltysiak
Leigh Ann explained that Table 6.1 only includes drug treatments when other types of treatments exist. She then suggested changing the table title to “Drug Treatment Options.”
Sam D. asked if Leigh Ann would like to include naturopathic approaches in the table, to which she replied that he may simply wish to differentiate between on-label, FDA-approved treatments versus other modalities.
Sam D. replied that he would discuss Leigh Ann’s comment with Dennis and revise the content accordingly.
Comment 8 by David Walker
Referring to his comment for Table 6.1, David explained that doxycycline is the preferred treatment for Rocky Mountain spotted fever.
Sam D. replied that tetracycline may need to be considered for treating certain other diseases.
Comment 9 by Ben Beard
Ben explained that the following statement is imprecise: “While treatment of early Lyme disease is generally successful, 10-20% of patients with Lyme disease suffer from relapses and persistent symptoms.” He recommended differentiating between early and initial treatment, which have different treatment success rates.
Sam D. replied that it could be challenging to include all the different treatment variables and added that the reader may not understand the nuances. He stated that he would consider including a reference for the statement.
Comment 10 by Eugene Shapiro
Referencing his comment about defining treatment failure, Gene prompted the group to move on to the next comment.
Comment 11 by Pat Smith
Pat suggested clarifying in the following sentence that the recommendation is for Congress to encourage treatment trials rather than conduct them: “Additional treatment trials are needed to determine if these patients could benefit from a longer period of treatment than the conventional 10-21-day course of antibiotics, and is part of the Working Group’s recommendation.”
Sam D. agreed to making Pat’s revision.
Comment 12 by Eugene Shapiro
Gene explained that the text he had highlighted (starting with “Tetracycline has been used successfully…”) refers only to uncontrolled trials and does not include references to previous controlled trials.
Sam D. explained that the 2018 Tick-Borne Disease Working Group Report to Congress included information on those previous controlled trials. He added that the intention of the text is to provide potential explanations for why some treatments have not worked while others may be effective. He described his clinical observations based on thousands of cases.
Gene suggested adding the word “uncontrolled” to the text. He also noted that the content is long and recommended condensing it.
Sam D. replied that he would review the trials and rationale provided in the chapter and revise the text to be more concise. He added that he could provide more information about the trials and why they did not show benefit.
Pat disagreed that they did not show benefit, noting that two trials did, in fact, demonstrate short-term benefits. She highlighted the importance of including information about the trials and conclusions drawn from them, as well as assessments by other researchers of those trials and conclusions.
Sam D. stated that he would discuss Pat’s suggestion with Dennis.
Gene commented that the benefits Pat referenced were outcomes for which the studies were not powered, and therefore cannot be used as definitive evidence.
Pat and Gene discussed the Fallon study and intravenous versus oral delivery of ceftriaxone.
David made a motion to delete the two highlighted paragraphs (starting with “Tetracycline has been used successfully…”).
Gene seconded the motion.
Sam D. disagreed with deleting the paragraphs and suggested that he and Dennis revise them to be more concise and to address Gene’s concern about the lack of information on the previous controlled trials.
Dennis agreed with Sam D.’s suggestion and added that the current references should be used to support the need to consider additional therapeutic approaches in order to improve patient outcomes.
David agreed with Sam D. and Dennis, and then withdrew his motion to delete the two highlighted paragraphs (starting with “Tetracycline has been used successfully…”).
Comment 13 by Leigh Ann Soltysiak
Leigh Ann stated that her comment about parasites, biofilms, and antibiotic effectiveness had been resolved. She prompted members to move on to the next comment.
Comments 14 and 15 by Ben Beard and Eugene Shapiro
Ben requested that Sam D. provide a reference for the in vivo data described in the following sentence: “Recent literature has described the presence of such organisms, including in vitro and in vivo data on persisting B. burgdorferi and the effectiveness of certain antibiotics, some in combination, on curing the persistent state (Sharma, Brown, Matluck, Hu, & Lewis, 2015).”
Sam D. replied that he would add a reference.
Gene suggested replacing “curing” with “reversing” because persistence is a state rather than a disease.
Sam D. agreed to Gene’s revision.
Comments 16 and 17 by Ben Beard and Eugene Shapiro
In reference to their comments about mouse models, B. burgdorferi, and persistence, Ben and Gene agreed that the issue had already been discussed.
Comment 18 by Eugene Shapiro
Gene disagreed with the following statement, adding that the content should be modified or deleted: “Previous clinical trials designed to evaluate safety and efficacy of treatment regimens for some of the early Lyme manifestations have not confirmed optimal treatment strategies.”
Sam D. replied that he would modify the content to address Gene’s concern.
Comment 19 by David Walker
David explained a reference is needed for persister cells in the following sentence: “Animal studies have shown that persistent B. burgdorferi are capable of altering and evading host immune responses and capable of forming persister cells following certain antibiotic treatments.” He asked what a persister cell is and how it is demonstrated in animals.
Sam D. replied that he would add references for both in vitro and in vitro studies, and he described persister cells.
Comments 20, 21, and 22 by Ben Beard
Ben explained that his comments were corrections of typographical errors.
The Working Group concluded its discussion of Chapter 6.
Review of Chapter 7: Clinician and Public Education, Patient Access to Care Review
Chapter co-lead Patricia V. Smith, President, Lyme Disease Association, Inc. made a statement prior to the discussion. She expressed her appreciation for the Training, Education, Access to Care, and Reimbursement Subcommittee for developing the subcommittee report. She pointed out that most of the public comments had been about Lyme disease, particularly persistent Lyme disease. She explained that she and Coop had developed this chapter based on their understanding that the writing co-leads were supposed to use content from the subcommittee reports to develop their chapters. She noted that she disagreed with the suggestions she and Coop had received during the writing process about re-balancing the content. She expressed her objection to the writing process and access to the SharePoint. Pat stressed that she and Coop focused Chapter 7 on Lyme disease, which in her view is balanced given that the burden of Lyme disease is greater than that of other tick-borne diseases and conditions.
Chapter co-lead 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, HHS, explained that he and Pat had accepted some suggestions and revisions, which they would not discuss further at today’s meeting. He noted that Sam D. had made some deletions and additions, which he and Pat will continue to review. He then led the discussion of the comments one by one.
The member who provided feedback was given the opportunity to explain his or her edit or comment. Next, responses to the feedback were provided by chapter co-leads (Pat and Coop). Finally, all members were given the opportunity to continue the discussion, reach consensus on how to proceed, and/or make motions and vote on proposed content changes.
The following is a summary of the Working Group’s discussion of Chapter 7.
Comment 1 from Leigh Ann Soltysiak
Leigh Ann commented that “healthcare provider” might be a more suitable term than “clinician.” Coop explained that “practitioner” might be best in terms of medical payment.
Given that the chapter title had been voted on and approved by the Working Group, no change was made to the chapter title.
Comment 2 from David Walker
David commented that the current version of the chapter content is not well aligned with the recommendations. He noted that three recommendations in Chapter 7 pertain to all tick-borne diseases other than Lyme disease; one pertains to all tick-borne diseases including Lyme disease; and only one recommendation is Lyme disease specific. However, he added that half of the chapter is devoted to only Lyme disease. He emphasized that the content of the chapter needs to support the recommendations. He recommended removing any content that does not do so.
Coop responded that the material presented in Chapter 7 is based on the number of cases, and that the reason the co-leads focused on Lyme disease is because it has the largest number of cases.
David reiterated that the content should support the recommendations. He also pointed out there is no recommendation on access to care.
Leigh Ann agreed that the chapter needs to address education and patient care and also be specific to and supportive of the five recommendations. Leigh Ann pointed out that two of the five recommendations apply to Lyme disease, but they include and cover other tick-borne diseases as well. She commented that Chapter 7 is organized differently from other chapters; specifically, she stated that while other chapters provide rationale to support each recommendations, the current version of Chapter 7 does not. Using the 2018 Tick-Borne Diseases Working Group Report to Congress as an example, Leigh Ann suggested the chapter co-leads use a standardized approach to organize the chapters, which would help the target audience to read and understand the rationales.
Coop noted that he and Pat are open to reorganizing the content to make the chapter more effective.
Pat expressed her view that this chapter should be different because it is the only chapter that focuses on patients.
Sam D. pointed out that one of his subcommittee’s recommendations was absorbed into this chapter. He emphasized the importance of clinician education. He noted that he would support the idea of emphasizing Lyme disease as long as other tick-borne diseases and associated education are adequately covered.
Coop responded that Sam D.’s suggestion is reasonable.
Comment 3 from Leigh Ann Soltysiak
Leigh Ann suggested using a standardized approach to organizing the chapter content. Specially, she stated that all of the recommendations should be listed at the beginning to be consistent with the other chapters.
Coop agreed.
Comment 4 from Dennis Dixon
Dennis noted there is no question that there are two primary clinical perspectives on Lyme disease, one typically attributed to the Infectious Diseases Society of America (IDSA) and the other to the International Lyme and Associated Diseases Society (ILADS). He commented that the current version of Chapter 7 is strongly biased towards ILADS and the position of the chronic Lyme disease advocacy community. He agreed that this position should be heard. However, he added that the content should be more balanced, so as not to give the impression that the Tick-Borne Disease Working Group as a whole has taken up the issue and reached the conclusions presented therein.
Dennis pointed out that the current version of the chapter is inaccurate in some cases (e.g. “NIH has funded just three research grants for persistent Lyme disease—the last one funded 15+ years ago”) and heavily biased towards one perspective throughout (ILADS). He noted that the chapter should have balance and should be edited to acknowledge unresolved differences.
Coop responded that the co-leads did go into the unresolved difference in the science and between IDSA and ILADS. He noted that part of the issue is IDSA had not yet released any new guidelines.
Dennis pointed out that the overall presentation is biased, and he suggested the co-lead edit the content to give clarification.
In response to Coop’s request, 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, HHS, clarified that the NIH had been studying the persistence issue and funding studies on persistence nearly every year since he had been there (18 years). He pointed out that the statement in Chapter 7 was referring to clinical trials, not research studies; and he suggested the co-leads make the correction.
Coop and Pat agreed to make Sam P.’s correction.
Dennis suggested starting with a description of the two unresolved approaches and moving on from there.
Coop agreed that the approach would work.
Comment 5, 6, and 7 from Leigh Ann Soltysiak and Ben Beard
Leigh Ann and Ben commented on the first sentence of the Background section: “Tick-borne diseases (TBDs) are increasing causes of illness in the United States, accounting approximately 75% of all nationally reported vector-borne diseases to the Centers for Disease Control and Prevention (CDC) each year.”
Leigh Ann suggested adding “disability” after “illness.” Coop agreed.
Ben suggested breaking the sentence up to improve clarity, and starting the sentence with “Tick-borne diseases account for approximately…” Coop agreed.
Sam D. noted that his comments were not tracked. He suggested 1) starting the sentence with “approximately 75%...” and deleting the first two sentences.
Coop noted that the he and Pat would revise the sentence based on Sam D.’s and Ben’s comments and suggestions.
The group further discussed the different interpretations and varied assessment results of the clinical trials.
Dennis again suggested starting the section by stating that there are differences of opinion in this area, which would suggest why more data and studies are needed.
Pat stated that she would not object to Dennis’s suggestion.
Comment 8 was not discussed at this time.
Comments 9-11 from Leigh Ann Soltysiak
Leigh Ann stated that the content provides rationale for the recommendation about Federal government websites and educational materials. She explained that the text might be more helpful to the reader if it appeared as rationale under the recommendation. She also stated that the information about estimated reported cases should be explained for the reader—whether it refers to new, acute, or chronic cases.
Coop replied that perhaps he and Pat could be clearer about reported cases versus projected cases. He stated that he would add the hyphen she suggested.
Deletions (pps. 1-2) by Sam Donta
Coop explained that Sam D. had made some deletions that he and Pat did not agree with, so they rejected those changes.
Comments 12 and 13 by David Walker and Leigh Ann Soltysiak
David commented that the costs of Lyme disease are not relevant to the recommendations of this chapter. He made a motion to delete the paragraph and table on costs.
Coop responded that “access to care” is included in the title of the chapter, and asked David why disagrees with including the information in this chapter. He added that if there is additional content available for Alpha-gal Syndrome and other diseases, he and Pat would be willing to add it. However, he stated, they did not find such content in the subcommittee reports.
David replied that the information does not support the recommendations.
Sam D. noted that Congress will look at the cost, and he expressed his view that not mentioning the cost would be a mistake.
Leigh Ann pointed out that “access to care” is implied in recommendation 7.1. She added that the recommendation covers the whole process of patient care, as well as the interactions involved. She noted that clinicians need to be adequately trained, and meanwhile patients need to know what the providers are doing. She emphasized that the entire flow/interaction is covered in recommendation 7.1 and, therefore, it needs to be addressed in the text.
Leigh Ann noted that recommendation 7.2 acknowledges clinician education on Lyme disease, and the same is true for other diseases.
David and Leigh Ann disagreed on whether or not costs and access to care should be addressed in this chapter.
Coop cautioned that if too much patient-related content is removed, patients will take notice.
David explained that inadequate clinician diagnosis is a key issue and clinicians need training to improve diagnosis of some of these other tick-borne diseases. David described a patient of his who experienced great difficulty getting a diagnosis from place to place. He pointed out that these other tick-borne diseases are not rare, especially in certain parts of the country.
Coop responded that as Lyme disease gets more attention, other tick-borne diseases will be noticed too.
Sam D. commented that other tick-borne diseases would not be excluded from Lyme disease education. He expressed his view the chapter needs to be inclusive; however, Lyme disease should be the focus.
Dennis pointed out that the key words of the recommendations are educational materials, curriculum, medical education, and Alpha-gal Syndrome awareness, which the Working Group is not discussing now.
Pat explained that the chapter provides background on the difficulties patients face as they try to access care, including the prohibitive cost. She disagreed with removing any of the material. She pointed out that CDC has conducted three studies showing that Lyme disease is underreported. She emphasized that Lyme disease should be the focus and that other tick-borne diseases are not discriminated against the way Lyme disease is.
David reiterated that the content needs to support the recommendations.
Pat once again disagreed with removing any of the material on Lyme disease. She referenced a Freedom of Information Act (FOIA) request related to the Federal government and the ILADS guidelines.
Leigh Ann suggested again utilizing a standardized structure to organize the content to avoid disagreement. Specifically, she recommended listing the recommendation first and then providing rationale to support the recommendation.
Ben commented that he understands both perspectives, and he suggested moving the information on burden of disease to the overall Background section of the report.
Leigh Ann agreed with Ben’s suggestion. She suggested using relevant information in the current version of the chapter to support the individual recommendations, then moving other material to the Background Chapter to see if it fits there.
Pat disagreed with moving the information to the Background chapter.
David commented that the statements on evidence-based medicine and conflicting guidelines is not relevant. He also noted that shared decision-making is part of the ethics of medicine, and every time the physician sees a patient, the patient plays a role in determining the treatment. He commented that shared decision-making does not need to be addressed in the chapter.
Pat responded that based on her experience with patient-physician interactions, a large percentage of doctors do not practice shared decision-making. She added that government entities are favorable of shared decision-making but it is not being done.
Coop voiced concern that the Working Group may not have time to go through every single comment, and he noted that many comments have repeating themes.
Leigh Ann noted that the Working Group needs to give everyone a chance to voice their view, and that Working Groups needs to go through every comment.
Coop agreed with Ben’s suggestion.
David reiterated his motion to remove Table 2 (“Lyme disease cost per patient in 2006 and 2018 [inflation adjusted]”) and the paragraph above Table 2 starting with “The costs attributed to Lyme disease…”
Leigh Ann noted that she did not take issue with including cost per se because it does fall under training, and it falls under what should be included for awareness under the website recommendation. However, she was concerned the cost discussed in the current version of the chapter is just a small portion of the cost, which does not include persistent ailment. The figure, she added, does not present the whole picture. She stated that each Working Group should address fresh topics, for example the 2020 report does not repeat the same topics that were addressed by the 2018. She was concerned that if the Working Group is going to mention cost in the 2020 report, the 2022 Working Group may or may not fully address the cost and lay out the whole picture.
There was no second to David’s motion.
Coop responded to Leigh Ann that he and Pat would take her comments into consideration.
Deletions (p. 2) by Sam Donta
Coop told Sam D. that he and Pat would consider his suggested revisions.
Comment 14 by Leigh Ann Soltysiak
Leigh Ann explained that her comment was intended to help connect the content with the recommendations.
Coop replied that he and Pat would take her suggestions into consideration. suggested making a broad statement about costs associated with tick-borne diseases to the health-ecosystem in terms of burden of disease.
Comments 15 and 16 from David Walker and Eugene Shapiro
Regarding David and Gene’s comments in the chapter about “patients with persistent/chronic Lyme disease,” Coop suggested instead using the term “persistent symptoms associated with Lyme disease.” He added that his preference would be to use “clinical manifestations” rather than “symptoms” because, he noted, there have be some objective signs observed by physicians.
Gene stated pointed out that many of the patients have symptoms but no objective clinical manifestations. He suggested using “persistent symptoms associated with Lyme disease.”
Ben agreed with the suggestion and explained that it is easier for the target audience to understand the term “symptoms.”
Coop and Pat agreed that the term “symptoms” would be best for the target audience.
Coop and David talked about the provenance of the content in Chapter 7 and disagreed on the relevance of some of the content to the recommendations.
Comment 17 on reference from Gene Shapiro
In response to Gene’s comment about missing references, Coop stated that they are in the Training, Education, Access to Care, and Reimbursement Subcommittee Report and will be provided.
Gene stated that it misleading to cite the patients in the NIH-funded clinical trials as demonstrating a common manifestation of Lyme disease given that substantial functional impairment was a requirement to be eligible to enroll in the trials.
Coop asked for suggestions on how to revise the content.
Gene suggested removing the term “functional impairment.”
Sam D. expressed his view that Congress needs to hear the phrase “functional impairment” to highlight that patients are unable to work or go to school.
Gene commented that it is okay to say the patients have functional impairment because they do; however, he added, functional impairment cannot be used as evidence to say the people in this study have impairment.
Sam D. then commented on the paragraph on cost and expressed his agreement with Ben’s and Leigh Ann’s suggestion to move the paragraph and table on cost to the overall Background Chapter of the report. He explained that it would be much more efficient to provide background that includes cost, disabilities, and emotional and other personal burdens in the overall Background Chapter, and focus Chapter 7 on educating health care providers and providing rationale for the recommendations.
Pat disagreed. She underscored that clinical trial-related information needs to remain in Chapter 7 because, in her view, that is part of physician education. She noted that physicians need to look at those trials and consider both sides.
Dennis cited a paper showing that the patient population included in the study did have functional impairment.
The group further discussed those trials, including the enrollment criteria.
Sam D. explained that his understanding of Pat’s point is that clinicians need to know these patients are functionally impaired. He suggested making the information clear and concise to avoid confusion.
Dennis agreed.
Coop stated that he and Pat would consider the phrasing.
Comments 18 and 19 by Gene Shapiro and Ben Beard
Coop noted that the topic has been discussed earlier and the co-leads will use the term “persistent symptoms associated with Lyme disease.”
Comment 20 from Leigh Ann Soltysiak
Leigh Ann noted that the Working Group had addressed the topic earlier and the co-lead agreed to use “practitioners.”
Deletions (p. 4) by Sam Donta
Sam D. noted that he had deleted the word “significant” before “case fatality rate” under the section on ehrlichial and anaplasmal diseases. He explained that the word “significant” is generally used for statistics, and he suggested using a different word.
Coop agreed to accept the deletions made by Sam D..
Comment 21 by Ben Beard
Ben corrected a minor grammar error (“Reported cases of both ehrlichiosis and anaplasmosis “are”--not “is”).
Coop accepted Ben’s correction.
Comments 22, 23, and 24 by Ben Beard
Ben explained that the official surveillance numbers for both Lyme disease and anaplasmosis/ehrlichiosis are shown in a table in the Rosenberg et al. 2018 paper. He explained that were data from 2004 to 2016.
Coop commented that the numbers included in the current version of the chapter were drawn from the Subcommittee report.
Ben further commented on the Madison article, which he said does not support the statements. Ben explained that he did not find the numbers in the paper and did not know where the numbers came from. Ben clarified that the actual reported cases of anaplasmosis and comparable information for ehrlichiosis are posted on CDC’s website. He also suggested keeping the section clean and using only the numbers in the Rosenberg report.
Pat said she was favorable to the suggestion.
Kevin recommended citing only the Rosenberg report and moving it up to the start of the section on ehrlichial and anaplasmal diseases. He added that it is the mostly widely cited report.
Ben further shared that new data (including the actual numbers updated for 2018) are all posted on CDC’s web, which is CDC’s official portal for posting official surveillance data.
Pat and Coop agreed with Ben’s suggestion and noted that they would revise the information.
Comment 25 by Angel Davey
Angel explained that she had originally commented there was some overlap under the section on Alpha-gal Syndrome with material used in Chapter 4. However, Sam D. subsequently deleted the duplicated information, and her comment as a result had been addressed.
Revisions/deletions (p. 5) by Sam Donta
Coop noted that Sam D. had made revisions in the paragraphs under Alpha-gal Syndrome, and he said he was okay with the revisions.
Comments 26 and 27 by David Walker and Leigh Ann Soltysiak
David commented that the section under “Limited, emerging, and unsettled state of science relating to persistent symptoms associated with Lyme disease” does not pertain to the recommendations in this chapter and should be removed.
Sam D. responded that the information could be incorporated in another area of the report if the co-leads want to keep the information in the report. He noted that otherwise he would agree with David. Sam D. acknowledged that the information is important, but he was not sure it fits in this chapter.
Pat responded that the text relates to the recommendation on Federal websites and educational materials, which, she stated, should include information stating that the science related to symptoms associated with Lyme disease is emerging and unsettled.
Leigh Ann noted that the section would need to be modified so that the material more directly supports the recommendations.
Coop and Pat responded that they will review the section to see if the material can be moved to the Recommendation section.
David stated that he had made a motion to remove the information under “Limited, emerging, and unsettled state of the science relating to persistent symptoms associated with Lyme disease” from this chapter. He explained that the information pertains to a recommendation included in a different chapter, but not recommendations in this chapter.
Pat responded that the information belongs in Chapter 7 because it pertains to the recommendation that references “the state of science.”
There was no second to David’s motion.
Pat prompted Coop to move on to the next comment.
Comment 28 by Eugene Shapiro
Gene commented that the trials discussed in the chapter had adequate statistical power to detect clinically meaningful effects. However, the trials did not detect clinically meaningful differences. Gene noted that numerous other clinical trials from other countries, some of which were quite large, found similar results. Regarding the small trial size of only 37 patients, Gene stated that only about 1% of the 3400 potential patients met the enrollment criteria, which included functional impairment. Referring back to the Working Group’s earlier discussion on “functional impairment,” Gene noted that the interpretation of the trials in this section is biased. Gene made a motion to remove the content in question.
Pat referenced a study conducted by Allison DeLong from Brown University. Pat noted that the primary finding of Allison’s was that the trials did not prove re-treatment was ineffective. In addition, two studies even found some statistically significant benefits.
Gene pointed out that many people have reached different conclusions.
Pat responded that there is a lot of information refuting the conclusions of those clinical trials, and she noted that another side of opinion needs to be presented.
Sam D. commented on his knowledge of the trial design. He added that this topic is about treatment, which is the focus of Chapter 6. For Chapter 7, Sam D. suggested Pat and Coop highlight that the trials have not provided answers, indicating to physicians that evidence is limited. He noted that Chapter 6 can discuss the clinical trials, explain why the treatments used in the trials were not effective, and suggest that other treatment options to be tested.
Pat noted that she and Coop could consider rewording. She reiterated that there are different opinions and that, she said, is why more clinical trials are needed. She added that she and Coop would not consider Sam D.’s suggestion unless both sides of opinion are presented.
Dennis commented that the varied results of the trials and subsequent reassessments do not definitively support the use of long-term antibiotics. He noted that the community needs to find out the answer that would give patients meaningful benefits. He suggested the Working Group not get distracted by who is right and who is wrong, but rather address that better information is needed to manage the illness and help the individuals.
Pat responded that because those trials are often being used to keep patients from getting antibiotics, they need to be posted on the Federal agencies’ websites to show there are different opinions and to suggest that more studies are needed to help patients.
Sam D. again pointed out the overlaps with Chapter 6 (Treatment), and suggested Pat and Coop focus on clinician training. He added that he would discuss clinical trials and antibiotic treatment in Chapter 4 (Clinical Manifestations, Diagnosis, and Diagnostics) and Chapter 6 (Treatment). He commented that those trials were well run, but the conclusions were limited.
He suggested stating that the trials did not lead to a compelling/decisive conclusion.
Coop noted that he was open to Sam D.’s suggestion.
Comments 29 and 30 by Eugene Shapiro
Gene commented that the following sets of statements are untrue:
- “The NIH trial findings were inconsistent, with some demonstrating treatment success and others not. Hence, few conclusions can be drawn from the few NIH-funded randomized controlled trials.”
- “Nor can it be concluded that repeated antibiotic therapy is robustly effective. One can conclude however that approximately 60% of patients with persistent post-treatment Lyme fatigue may experience meaningful but partial clinical improvement in fatigue with antibiotic retreatment.”
Gene stated that it is inappropriate to draw conclusions about outcomes for which a trial is not powered. He added that this is biostatistically, epidemiologically incorrect. He then made a motion that the content be removed.
David seconded Gene’s motion.
Sam D. suggested the co-leads revise the paragraphs based on Gene’s comments.
Gene noted that he would withdraw his motion if the language will be revised.
Coop confirmed that the co-leads would work with Sam D. to revise the language on clinical trials based on Gene’s comments.
Comment 31 by David Walker
David commented that the two pages under the subheading “Evidence-based medicine and conflicting guidelines in Lyme disease” do not pertain to the recommendations in this chapter. He stated that it is inappropriate to vilify the IDSA teams that have analyzed the scientific evidence in order to provide the most effective care for patients. David stated the IDSA guidelines are inaccurately portrayed in this section, explaining that they are patient-oriented rather than research-oriented. He added that treatment of an individual is based upon a clinical diagnosis. He also commented that the guidelines are evidence-based and required that the studied patients had Lyme disease. However, he noted, clinicians do not require these criteria to initiate treatment on individual patients.
Pat disagreed.
David further commented that the belief in the effectiveness of longer treatment is not supported by scientific evidence. He reiterated that the characterization of IDSA guidelines as research-oriented, not allowing clinical judgment, and not allowing shared decision-making is an untrue. He noted that a physician who believes that longer treatment is merited can present the pros and cons of this approach to the patient, and that this section does not belong in the Tick-Borne Disease Working Group Report.
Pat responded that ILADS guidelines are the only ones that meet the Institute of Medicine/National Academy of Medicine’s requirements for guidelines.
Gene, Pat, and David continued to discuss other aspects of the ILADS guidelines.
Sam D. suggested condensing the section and acknowledging that there are two existing guidelines without judging the validity of the guidelines to avoid confusing clinicians. He noted that the topic is important but perhaps needs to be placed in another area. He advised the Working Group to remain objective and focus on what we know and don’t know and move forward.
Dennis agreed with Sam D. regarding acknowledging up front that there are two different unsettled opinions.
Coop agreed with Sam D. and Dennis. He noted that he and Pat would consider how to present the information.
Dennis suggested toning done the opinion and avoiding accusatory/inflammatory statements.
Kevin pointed out that it would be much easier for the target audience to read if Chapter 7 were structured consistently with other chapters (that is, presenting recommendations and providing rationales). He asked the co-leads to think how best to align the chapter content with the recommendations.
Coop expressed appreciation for Kevin’s comment and suggestions.
Beto reminded the Working Group members to consider the 2018 Tick-Borne Disease Working Group Report to Congress and avoid repeating what has been addressed. He stressed the importance of highlighting the dimensions of human suffering and encouraged thoughtful consideration of where and how to portray that information based on what has already been covered in the previous report.
Pat responded that Congress changes every years and therefore important information about Lyme disease still needs to be included in this report even if that had been covered in the last report to Congress. She stated that the only thing that resulted from the last Working Group report was that NIH developed a strategy. She added that the Lyme disease community did not get anything they wanted.
Sam D. asked if the Working Group could adjourn soon and discuss other chapters at the next meeting or set up an additional meeting.
Leigh Ann responded that the Working Group needs to try to finish Chapters 7 and 8. She noted that the next Working Group meeting will be a two-day meeting (August 13 and 14, 2020).
Comment 32 by Leigh Ann Soltysiak
Leigh Ann stated that her comment on the topic of “evidence-based medicine and conflicting guidelines in Lyme disease” had already been addressed in a previous discussion. She prompted the Working Group to move on to the next comment.
Comments 33 and 34 by David Walker and Leigh Ann Soltysiak
Coop noted that David’s comment pertains to shared decision-making, which had already been discussed. Coop asked David how he would like to address the comment.
David commented that it is the standard of care for physicians and patients to exercise shared decision-making. He pointed out that continuing medical education includes medical ethics every year and that shared medical decision-making is routinely employed in clinical practice. He added that it is inaccurate to imply otherwise. He noted this section is not appropriated for Chapter 7.
Coop disagreed that the information is inappropriate in this chapter. He noted that the term “shared decision-making” did not appear in a Federal publication until 1982, and it was not mentioned in medical literature as a concept of ethics until the late 1990s. Coop acknowledged that shared decisions-making is a standard of care. However, he added, standards of care are ideal but not always practiced. He stated the it does go to the core of clinician education.
David responded that the concept has been around for 25 or 35 years and clinicians have been taught it. He noted that the topic does not pertain to the recommendations.
David asked Coop how the section could be revised.
Coop replied that he and Pat had not agreed to revise it. He asked David if he was requesting to have it removed, to which David replied yes.
Leigh Ann disagreed to remove the information. She suggested to tie it to Recommendation 7.1 and 7.2 instead. She commented that certain language in the current version of the chapter appears to be editorial, which, she noted, is not necessary. She suggested removing some of the wording and keeping the content specific to providing rationale for the training and education part of recommendation 7.2 as well as the training and education/awareness in Recommendation 7.1. Leigh Ann also noted that shared decision-making covers other tick-borne diseases as well, not just Lyme disease.
David made a motion to remove the section on shared-decision making.
There was no second to David’s motion. The Working Group moved on to the next comment.
Comment 35 by David Walker
Coop thanked David for the comment on clinician training.
Comment 36 by Angel Davey
Coop read Angel’s comment about the lack of continuing medical education on tick-borne diseases in the military health system and noted that he and Pat will elaborate to cover not only active duty Service members but also veterans, beneficiaries, and family members.
Addition/deletions (pps. 10 and 11) from Sam Donta
Coop noted that he and Pat will review Sam D.’s insertions and deletions.
Comment 37 by Eugene Shapiro
Gene prompted the Working Group to move on to the next comment.
Comment 38 by David Walker
David commented on the section that begins “Because the IDSA is so influential…” He stated that the content is inappropriate, inflammatory, and not based on evidence. Gene agreed.
Coop asked David if he thought the whole section should be removed, to which David replied yes.
The Working Group moved on to the next comment.
Comment 39 by Gene Shapiro
Gene commented on the section that begins “Because the IDSA is so influential…” He stated that the issue is not the "existence" of divergent views. The issue, he added, is their scientific validity.
After explaining his comment, Gene asked the Working Group to move on to the next comment.
Comment 40 by David Walker
Referencing David’s comment about the physician’s oath to “First, do no harm” and the use of prolonged antibiotics, Coop asked if it was David and Gene’s intention to remove all of the content on page 11.
David replied yes and stated that prolonged antibiotic treatment has been shown to be harmful. He added that the implication that physicians are unwilling to help a patient when they advise against something potentially harmful is wrong.
Coop acknowledge that he understood the issues associated with long-term antibiotic use. He noted there might be some other treatment options out there.
Kevin commented that the section reads like a position statement that may not be reflective of the entire Working Group. He pointed out that the section, especially the paragraph starting with “Because of…,” which the group discussed earlier, is somewhat inflammatory. He suggested rephrasing the content to remove the tone while still highlighting that there are two difference perspectives.
Leigh Ann asked if Pat and Coop are open to the overall approach of reorganizing the content so that it provides rationale for the recommendations, in addition to language revisions and edits.
Coop noted that he would be open to revisions, including moving information around, as long as it did not involve cutting entire sections.
Comment 41 by Angel Davey
Regarding Angel’s comment on the inconsistent use of ‘DoD” versus “U.S. military,” Coop explained that the recommendation had been voted on and accepted by the Working Group. He noted that he and Pat could clarify those references in the supporting statements.
Comment 42 by David Walker
Referencing his comment for Recommendation 7.2, David stated the recommendation purports to address training and education on Lyme disease and other tick-borne diseases, but the rationale provided is for Lyme disease only.
Coop agreed that the supporting paragraph could benefit from including discussion of the need for education of other tick-borne diseases. He noted that he would revise and will emphasize the need.
Comment 43 by Gene Shapiro
Regarding Gene’s comment on the last sentence of Recommendation 7.2, Coop responded that the recommendation had been voted on.
Comment 44 by Ben Beard
Coop agreed with Ben’s comment that “the recommendation does not support the requirement for a non-government curriculum development team…[and doing so] poses FACA violation risks.”
Ben explained that the original recommendation was voted down; however, the text associated with it was added back in.
Coop agreed that the statement needs to be revised in a way that supports the recommendation.
The Working Group concluded its discussion of Chapter 7.
Wrap-up
Leigh Ann explained that the meeting would adjourn but there would be a two-day meeting in August in order to address the remaining chapters. She stated that a revised agenda would be sent to the Working Group.
Dennis asked Pat to provide him with the NIH citation she had referenced about the number of deaths attributed to Lyme disease, to which she agreed.
Pat emphasized the need for transparency and stated that meeting documents should be made available to the public prior to the meeting so they can prepare comments.
Jim responded that documents are provided to the public as soon as they get clearance from several agencies to be posted on the website.
Gene asked if there would be a poll to determine the August meeting dates, to which Jim replied yes.
Kaye thanked members for their participation and highlighted the importance of adhering to FACA regulations and the Sunshine Act. She added to Jim’s statement that, as soon as documents are cleared by the agencies and made 508-compliant, they are posted to the Working Group’s website. She stressed that the Working Group’s discussions are open and in the public domain.
Jim acknowledged that a lot of controversial issues had been addressed and that the webcast would be posted as soon as it was cleared and made 508-compliant. He added that the Working Group welcomes all feedback.
David and Leigh Ann thanked members for their participation.
Adjournment
The meeting was adjourned at 7:22 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 (Gene) 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 (Pat) 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 (Present)
- 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, 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 Policy Fellow, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services
Appendix 3: Writing Groups for the 2020 Report to the HHS Secretary and 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
