TBDWG September 15 and 22, 2020 – Meeting Summary

Day 1: Tuesday, September 15, 2020, 9:00 am--3:00 pm Eastern
Day 2: Tuesday, September 22, 2020, 9:00 am--3:00 pm Eastern

Note: For context and clarity, speaker credentials will be included upon first mention in each meeting’s summary. Subsequently, individuals will be referenced by their first names to equalize expertise across the many diverse disciplines represented in this document. All perspectives and expertise, including patient-lived experience, is valued equally. Speaking on a first-name basis helps the Tick-Borne Disease Working Group ensure that all voices are heard and valued based on merit and without the bias of titles, eminence, or prestige.

Welcome and Roll Call: Day 1

James (Jim) Berger, MS, MT (ASCP), SBB, Designated Federal Officer (DFO) for the Tick-Borne Disease Working Group, Senior Blood and Tissue Policy Advisor, Office of Infectious Disease and HIV/AIDS Policy (OIDP), Office of the Assistant Secretary for Health (OASH), U.S. Department of Health and Human Services (HHS); called the meeting to order and welcomed all meeting attendees. Jim then conducted roll call (see Appendix 1 and Appendix 2: Tick-Borne Disease Working Group Members and HHS Support Staff). The meeting started with a quorum.

Co-Chair Welcome, 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 commented that, including Meeting 15, the Working Group would meet five more times before submitting their 2020 Report to Congress in December 2020. He added that he was hoping for a strong finish.

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 14 and highlighted the work that had been accomplished since then, namely, that the Working Group had reviewed and discussed Chapters 3 through 7, gone over feedback on those chapters, and worked to resolve comments.

Leigh Ann outlined the Day 1 meeting agenda, explaining that, in addition to hearing from members of the public and the Public Comments Subcommittee, the Working Group would be reviewing and discussing Chapters 8, 9, 1, and 2, as well as the Table of Contents and Title Page (in that order).

Leigh Ann also presented the Day 2 meeting agenda, stating that it would take place on September 22, 2020, during which time the Working Group would review and discuss the revised versions of Chapters 3, 4, 5, 6, and 7.

David explained that the purpose of the Day 1 meeting is to review and 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 Congress, pointing out that Meeting 16 would take place on October 27, 2020. She added that Meetings 17 and 18 would take place in November and December (dates to be determined). The final deliverable, she concluded, would be presented to Congress in December 2020 and available to the public on the Tick-Borne Disease Working Group website.

Overview of the Working Group’s Mission Statement, Vision Statement, and Values

Jim reviewed the Working Group’s Mission Statement, as follows:

The Tick-Borne Disease Working Group’s mission, as mandated through the 21^st Century Cures Act, is to provide expertise and to review all efforts within the Department of Health and Human Services related to all tick-borne diseases, to help ensure inter-agency coordination and minimize overlap, and to examine research priorities. As part of this mandate, and in order to provide expertise, we will ensure that the membership of the Working Group represents a diversity of scientific disciplines and views and is comprised of both Federal and non-Federal representatives, including patients, 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.

Working Group Objectives

Leigh Ann then outlined the Working Group’s charge, as follows:

• No later than two years after the date of enactment of the authorizing legislation, develop or update a summary of
  1. Ongoing tick-borne disease research, including research related to causes, prevention, treatment, surveillance, diagnosis, diagnostics, duration of illness, and intervention for individuals with tick-borne diseases;
  2. Advances made pursuant to such research;
  3. Federal activities related to tick-borne diseases, including
     1. Epidemiological activities related to tick-borne diseases; and
     2. Basic, clinical, and translational tick-borne disease research related to the pathogenesis, prevention, diagnosis, and treatment of tick-borne disease.
  4. Gaps in tick-borne disease research described in 3b;
  5. The Working Group’s meeting; and
  6. The comments received by the Working Group.
• Make recommendations to the Secretary regarding any appropriate changes or improvements to such activities and research; and
• Solicit input from States, localities, and non-governmental entities, including organizations representing patients, health care providers, researchers, and industry regarding scientific advances, research questions, surveillance activities, and emerging strains and species of pathogenic organisms.

Public Comments

Leigh Ann introduced the public comment session. She briefly explained the process for giving verbal comments at the meeting and added that all members of the public are welcome to provide written comments online (https://www.hhs.gov/ash/advisory-committees/tickbornedisease/contact-us/index.html) or via email ([email protected]).

Nine members of the public provided comments over the phone.

Karen Duffy: Karen introduced herself as a survivor and advocate. She reported years of struggles. She cited being misdiagnosed, then, after testing positive for Lyme disease, being ignored. She explained that, in addition to Lyme disease, she also has multiple coinfections. Karen described how she had been in and out of hospitals in the last eight months and had felt like no one seemed to want to deal with her and her symptoms. She stated that she had been sent home still severely ill. She commented that she had tried many remedies that failed to work, and she described the losses she had sustained, from identity to family, friends, and income.

Karen expressed frustration at the skepticism she felt from the medical community toward her and other patients with Lyme disease. As a result, she explained, many patients discontinue consulting with doctors, while others endure what feels like abuse from the medical system.

Karen described her current worsening condition. She reiterated how her symptoms persist, in spite of negative tests, and how patients with Lyme disease continued to be ignored by the government and insurance companies. She questioned why further research was not being conducted to investigate the connection between Lyme disease and Alzheimer’s disease. She concluded with a plea for help for sufferers of persistent Lyme disease.

Lucy Barnes: Lucy highlighted the large number of scientific papers showing the existence of chronic Lyme disease and its destructive effects. She commented that four decades have passed since the discovery of Lyme disease and billions of dollars spent, yet accurate diagnostic tests and treatment have yet to materialize. She stated her belief that the Working Group was ignoring the science and clinical data while funding was being directed to unreliable private and government agencies that fail to help change the current unacceptable situation.

Lucy urged the Working Group to remember that many lives were at stake and expressed criticism of those who deny the existence of chronic Lyme disease. She commented that countless tragic consequences resulted from ignoring evidence and neglecting to address chronic Lyme disease. She urged Working Group members to give it the attention it deserves in the 2020 Report to Congress and future reports.

Phillip Sewell Parnell, Sr.: Phillip expressed his support of the Working Group’s efforts. He explained that he and his children suffer from tick-borne diseases. He recounted how he first showed symptoms in 2002 and was diagnosed in 2016. He described the skepticism he felt from his health care providers, who assumed he was seeking pain medications. He related the devastating effects of the illness on his relationships and described the severe symptoms he has suffered, from leg and hand pain to momentary paralysis.

Phillip noted that he sought treatment but was turned away by many practitioners. For 10 years, he stated, no one agreed to test him, until a small local office did and found he tested positive for Rocky Mountain spotted fever. He added that he was put on weeks-long treatments, one of which caused a negative reaction. Describing himself as entrepreneurial and industrious, running two companies and working for himself before he was ill, Phillip stated that now, he can barely do math. He suggested the creation of a liaison group that would work with patients seeking care.

Carl Tuttle: Carl referred to an email he had sent to a Working Group member that included a list of studies identifying persistent Lyme disease after extensive antibiotic treatment. He gave an example of a patient who died after her insurer denied coverage of additional intravenous antibiotic treatment. He relayed that her autopsy showed findings consistent with neurological manifestations of chronic Lyme disease.

Carl asked how it is possible to claim that there is no evidence of persistent infection after extensive antibiotic treatment in the face of actual confirmation that these infections do persist despite treatment. He also commented that denying persistence has led to the misclassification of chronic Lyme disease as a low risk and non-urgent health threat. He underscored that, instead, the disease was caused by an antibiotic-resistant superbug. Carl stated that this misclassification has led to hundreds of thousands, if not millions, of people finding themselves in a debilitated state. He concluded by stating that he would follow up with an email to the Working Group containing the autopsy results.

Erin Walker: Erin introduced herself as the wife of PGA Tour winner Jimmy Walker. She stated that she is also on the board of directors of the Global Lyme Alliance. She recounted how, in 2017, her husband tested positive for Lyme disease, in addition to West Nile, mono, and other illnesses. She explained that despite 18 months of treatment, he continues to experience exhaustion, depression, and flu-like symptoms. She added that the neurological effects of Lyme disease may well spell the end of his ability to compete at high levels.

Diagnosed with Lyme disease in 2017, Erin described how she experienced a completely different set of symptoms from her husband’s. She also mentioned that her symptoms, currently milder, have not subsided despite a nine-month course of treatment. She explained that she and her husband feel lucky because they had been diagnosed early and had lived active, relatively normal lives, unlike what many in the U.S. suffer. She asserted that accurate testing was of paramount importance in helping alleviate patients’ suffering.

Erin argued that the chronic or post-treatment Lyme disease (PTLDS) designation adopted by this group was not resulting in improvements in the health of Lyme disease sufferers. She called for access to accurate testing and insurance coverage. She asked for recognition that this condition is real and an end to the stigma and skepticism surrounding this disease. She underscored that, despite three of four family members testing positive for tick-borne diseases, health care providers in her state do not think they have it.

Marlene Coelho: Marlene explained that her first symptoms arose in 2015—from muscle weakness to memory loss and crushing fatigue. She described how her health care providers found nothing wrong and advised her to see a psychiatrist after her tests came back negative. She explained that she had to quit her job and move in with her parents. She noted that after seeing 25 doctors, she finally tested positive for Lyme disease and babesiosis and began treatment right away. She reported that, after four years, in spite of continued struggles, she felt much better.

Marlene expressed her dismay that Working Group members appeared to ignore the science and the scientific method. She revealed that she had had great hopes when the Working Group was formed, in particular that the broken medical system could be fixed. She questioned, however, how to reconcile the Working Group’s purported intentions with the potential conflicts of interest among members. Marlene advocated for a change in member composition to ensure that the Working Group devotes its efforts to advancing the interests of patients with chronic Lyme disease and to including their voices in the discussions on priorities for research.

Jillian Gordon: Jillian explained that she is a clinical social worker in New York, and her adult son had tick attachments in 2013 and 2014. She described how it took three admissions to a local hospital for him to get minimal treatment. She recounted his persistent symptoms, ignored and denied by his health care providers. She stated that his illness has now evolved into neurological Lyme disease. She shared that his positive Lyme disease tests have not been acknowledged and that he was currently confined in a New York State psychiatric facility. She stated that his Lyme disease and associated tick-borne diseases had progressed to the point where, without help, he would likely die in the New York mental health system.

Jillian commented that her son had been denied treatment because of CDC’s lack of acknowledgement of the International Lyme and Associated Diseases Society (ILADS) guidelines. She stated that the Infectious Diseases Society of America (IDSA) guidelines were used by her son’s health care providers to deny his treatment. She stressed her inability to seek legal protection because the legal system also relies exclusively on the IDSA guidelines. Jillian asked for help in preventing her son’s premature death from untreated neurological Lyme disease. She called for the inclusion of the ILADS guidelines on the CDC website. She also urged that someone within CDC or HHS be assigned to investigate her son’s case.

Elizabeth Bonitz: Elizabeth stated that she was calling from central North Carolina in collaboration with Tick-Borne Conditions United. She recounted how, this past spring, she had sustained six tick bites in 10 weeks. She reported that, after becoming ill, she had brought the six ticks to her primary care physician and requested doxycycline. Her doctor, she said, ran blood tests, which he told her were negative, and failed to give her any treatment. Elizabeth described her worsening symptoms, her return to her primary care facility, and her plea for further testing. Her certified nurse midwife, she revealed, put her on doxycycline. She said that later blood tests came back positive for Rocky Mountain spotted fever (RMSF).

Elizabeth expressed concern about the diagnostic delay and questioned whether she might have lost her life had it not been for her nurse’s prescription. She indicated that her symptoms did not appear to be typical of RMSF. She urged for more continuing education for health care providers and pleaded for treatment to be given pending lab confirmation. She also stated that antibiotic treatments may be required for longer durations than the currently posted recommendations. She concluded by requesting that clinicians and relevant websites be given more updates on current information, including:

1. RMSF can present without fever or rash;
2. Clinicians should not delay treatment pending lab results when tick-borne illness is suspected; and
3. It is not uncommon for RMSF to need more than one round of doxycycline for recovery.

Carmen Payne: Carmen identified herself as an educational ambassador with the Global Lyme Alliance. She revealed that she had suffered from Lyme disease and coinfections for 27 years. She described her symptoms and relayed how she was told repeatedly over 26 years that Lyme disease did not exist in California and that her positive test results were false positives. Carmen explained that she has since been diagnosed with babesia, tick-borne relapsing fever, and bartonella, in addition to Lyme disease. She shared her realization that the medical community lacks knowledge on tick-borne diseases.

Carmen asked the Working Group to address the education of the medical community, starting with medical school. She reminded members about the importance of early and accurate diagnosis, and the irreparable damage that is caused to countless people when they do not have it. She also stressed that because it is a multi-system disease that can affect every organ, Lyme disease is an all-doctor specialty rather than one reserved for infectious disease specialists. Therefore, she urged, all clinicians should be trained on tick-borne diseases and be required to complete continuing education units in tick-borne illness.

Public Comments Subcommittee Update

David introduced the Public Comments Subcommittee Members (Appendix 3: Public Comments Subcommittee Members) and turned the meeting over to Angel M. Davey, PhD, Program Manager, Tick-Borne Disease Research Program, Congressionally Directed Medical Research Programs, U.S. Department of Defense, who described the subcommittee’s purpose, explained how public comments are received and processed, and provided a summary of key themes and priority areas raised by members of the public from April through July of 2020. Angel stated that all comments received were read and taken into consideration by the Working Group, and she highlighted the importance of addressing the public’s call for effective and affordable treatment.

Chapter 8: Epidemiology and Surveillance Review

Leigh Ann began the discussion of individual chapters and member feedback by explaining that chapter co-leads would be asked to present member comments in their chapter, one by one, and explain revisions made in response. She then turned the meeting over to Chapter 8 co-leads Charles Benjamin (Ben) Beard, PhD, Deputy Director, Division of Vector-Borne Diseases, Centers for Disease Control and Prevention, HHS; Associate Editor, Emerging Infectious Diseases, and 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.

The following is a summary of the Working Group’s discussion of Chapter 8.

Comment 1 from Pat Smith

In her comment, Patricia (Pat) V. Smith, President, Lyme Disease Association, Inc. expressed concern about version control in Chapter 8. Ben expressed confusion as well, noting that one paragraph, one figure (“Figure 1. Total Reported Tickborne Disease Cases, 2004-2008”), and one table (“Table 1. Reported tick-borne disease cases and all vector-borne disease cases, 2004-2018”) had been removed from the document without tracked changes. Ben read aloud the text that was missing (as follows), and the group looked at the figure and table referenced therein.

The number of TBDs reported each year has been increasing steadily over the last 2 decades (Figure 1). TBDs currently account for almost 80 percent of all nationally notifiable vector-borne diseases reported to the CDC each year (Table 1). In 2017, 59,349 cases of TBDs were reported to CDC, a 22% increase over reported cases in 2016. This count was the highest number of TBD cases ever reported in a single year in the United States and included 42,743 Lyme disease cases, 7,718 anaplasmosis and ehrlichiosis cases, 6,248 spotted fever rickettsiosis cases, 2,368 babesiosis cases, 239 tularemia cases, and 33 Powassan virus cases. Under-reporting is a common phenomenon for most high-incidence diseases. For Lyme disease, the actual number of annual cases has been estimated at 8 – 12x higher than the number of reported cases (Hinckley et al., 2014; Nelson et al., 2015). Under-reporting also occurs for anaplasmosis, ehrlichiosis, and rickettsiosis as well.

Members expressed general agreement that the content should be reinstated into the chapter.

Vote

Fourteen members voted yes to reinstate the paragraph, table, and figure that had been removed from Chapter 8. The motion passed.

Question from Pat Smith

Before moving on to the comments in the margins of the chapter, Pat asked Ben to explain the link to the CDC website provided in the Background section, noting that it does not contain information about the surveillance program being discussed but that it does reference clinician guidelines.

Ben explained that the URL is intended to be used as a reference for the data in the Background section. He suggested leaving out the URL or including a more direct link to the surveillance information.

Working group members expressed preference for including a more direct link.

Question from Sam Donta

Referencing two figures that had been pulled up on the screen at the start of the discussion (“Figure 2a. Reported human cases of Lyme disease—United States, 2018” and “Figure 2b. Distribution of Ixodes scapularis and Ixodes pacificus in the United States, 2020”), Sam T. Donta, MD, Professor of Medicine (retired), stated that Figure 2a is not needed in Chapter 8 because it does not add insight into the issue of high- versus low-incidence states for Lyme disease.

Ben responded that Figure 2a is not currently in the chapter. He added that Figure 2b will be featured in Chapter 3 to contribute to the discussion of tick surveillance.

Comment 2 from David Walker

Ben stated that, if David could provide a reference for Rocky Mountain spotted fever case fatality rates, he would add it to the chapter.

David commented that he preferred to leave the statement as is.

Pat, Leigh Ann, and 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, HHS, emphasized the need for a reference because the statement refers to an untested hypothesis.

Sam, Gene, and Kevin R. Macaluso, PhD, MS, Locke Distinguished Chair, Chair of Microbiology and Immunology, College of Medicine, University of South Alabama, suggested alternative wording. However, the group did not agree to change the statement.

David agreed to provide a reference for the Rocky Mountain spotted fever case fatality rates cited in the chapter.

Comment 3 from Angel Davey

Angel began by explaining that, although her comment is attached to the minority response, her comment does not pertain to it. She clarified that she felt it was important to connect hazard versus risk in Chapters 3 and 8, as discussed during Meeting 14. She suggested that perhaps the connection could be made in the Background chapter.

Adalberto (Beto) Pérez de León, MS, PhD, Director, Knipling-Bushland U.S. Livestock Insects Research Laboratory, United States Department of Agriculture—Agricultural Research Service, suggested a correction to a sentence in the minority response.

Pat responded that minority responses are not up for discussion.

Regarding Angel’s suggestion, Leigh Ann stated that the link between hazard and risk could be discussed when the Working Group reviews the Background chapter.

Beto added that hazard and risk are already covered in Chapter 3.

Comment 4 from Angel Davey

Angel explained that, as a member of the Public Comments Subcommittee, she had noted concern from the public about possible pathogen transmission via blood transfusion and stem cell transplant.

Sam replied that these issues are covered in the recommendation under the term “non-tick-bite transmission,” adding that the issues of blood transfusion and stem cell transplant could be mentioned in the rationale for the recommendation.

Pat agreed and recommended stating the need for further study of Borrelia burgdorferi transmission via blood transfusion, stem cell products, and other insects (for example, mosquitos and biting flies).

Ben suggested stating simply that additional studies are needed of the incidence of potential maternal-fetal and other non-traditional routes of transmission.

Sam agreed with Ben that the language should not be overly prescriptive and offered to work with Ben and Gene on revising it.

Pat reiterated that she thought specific language should be included about which vectors, pathogens, and routes of transmission should be studied.

Sam explained that the experts in the Pathogenesis and Pathophysiology of Lyme Disease Subcommittee evaluated existing research and decided to prioritize maternal-fetal transmission in their report.

Pat commented that more research is needed about non-tick vectors, particularly in areas of the United States where black-legged ticks are not as prevalent, yet people still have Lyme disease.

Leigh Ann suggested listing them in order of priority.

Sam stated once again that the Pathogenesis and Pathophysiology of Lyme Disease Subcommittee did not analyze in depth the issues of breast milk, stem cells, and blood transfusion as factors in transmission. Therefore, he added, he did not think it was appropriate to bring up these new areas in the 2020 Report to Congress. He suggested that the 2022 Working Group consider covering these issues.

David agreed with Sam.

Coop reminded the group that the point of Angel’s comment was to address concerns that have been brought up by the public. He added that he did not think it was necessary to introduce a lot of new content; rather, the Working Group could simply acknowledge these concerns.

Pat questioned Sam’s comment about adding new material, noting that new material had been added throughout the process. She stated that the content included in the 2020 report can provide a basis for the 2022 report. She mentioned that she would not object to a list of priorities, as suggested by Leigh Ann, and re-emphasized that the issues at hand need further study.

Ben reminded the group that the report is to Congress and cautioned them about listing details that may not have meaning to the intended audience. He recommended keeping the content high level rather than writing a new paragraph and prioritizing research items.

Leigh Ann clarified that the list would contain no more than two or three items.

Leigh Ann and David suggested that Sam work with Ben and Gene to refine the wording.

The Working Group concluded its discussion of Chapter 8.

Chapter 9: Looking Forward Review

Led by Chapter 9 writing co-leads, Leigh Ann and David, the Working Group reviewed the chapter and discussed member feedback. The following is a summary of the Working Group’s discussion of Chapter 9.

Comments 1 through 4 from Eugene Shapiro

The group agreed that because the first four comments pertained to recommendations, they would be disregarded.

Comment 5 from Angel Davey

Referring to the proposed graphic (entitled “Figure 9.2 Stakeholder Map”), Angel asked which stakeholders the Working Group thought should be included.

Leigh Ann described the graphic and explained that it was in the process of being developed.

Pat commented that stakeholders had already been defined and that any others could participate in Working Group subcommittees. She expressed concern about the emphasis on industry in the chapter and asked why the Federal Inventory recommendations were presented in the same chapter as this content.

Leigh Ann explained that industry is one of the many stakeholders, and that the chapter is recommending improved collaboration with industry to address unmet patient needs.

Pointing to Figure 9.3: Chronic Disease Regional Care Model, Pat asked if the chapter was recommending the creation of a regional healthcare system.

Leigh Ann clarified that the graphic is borrowed from a cancer practice model and could serve as an example framework for stakeholder collaboration.

Beto asked if the figure would be adapted.

Leigh Ann replied that it did not need to be included in the chapter. She suggested looking to other care models to borrow best practices.

Pat stated that she did not think the framework was needed for the Working Group to fulfill its mission. She added that industry stakeholders could be included in the subcommittees. She suggested focusing the chapter on existing stumbling blocks, for example acknowledging and addressing persistent infection.

Leigh Ann agreed to remove the graphic. However, she disagreed that the inclusion of industry as a stakeholder is not necessary and explained that industry is needed to address unmet patient need and to fill gaps in research.

Sam commented that the reference to a regional healthcare system should be removed and agreed with Leigh Ann that industry is needed to help find new markers. He added that he did not think industry would get involved with researching antibiotics because those that are currently available are generic.

Leigh Ann replied that generic antibiotics represent only part of treatment protocols, adding that innovation in that area can still occur. She also highlighted the need for enhanced symptom management, another area where industry could play a role in the future.

Pat stated that industry would be reluctant to get involved with Lyme disease. She noted that it is the job of the Working Group to convince Congress to invest in needed programs. She expressed concern that focus on industry was changing the character of the group.

Leigh Ann reiterated the importance of collaborating with industry.

Pat commented that better tests and research are needed first, which will prompt industry to get involved.

David agreed with Pat about testing and added that there are recommendations in the report to that effect. He explained that the precedent for the Looking Forward chapter from the 2018 Report to Congress is to include the Federal Inventory recommendations and suggestions for what the next Working Group could pursue.

Dennis M. Dixon, PhD, Chief, Bacteriology and Mycology Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, HHS, agreed that diagnostics are a major stumbling block and inquired about the timeframe for the Looking Forward chapter and, specifically, for involving industry.

Sam suggested reworking the section about industry to make it more about what role industry could play.

Dennis suggested rethinking Figure 9.3.

Beto commented on the possibility of raising awareness of tick-borne diseases within industry and gave two examples—related to mosquito-borne diseases and agriculture—for the Working Group to consider.

David stated that, without the title, Figure 9.3 could work because it contains important elements that can be applied to tick-borne diseases.

Pat and Dennis agreed with David on revising the graphic.

Leigh Ann agreed to revise the industry content and rework the graphic.

Comment 6 from David Walker

David explained that he did not want to mix discussions of chronic disease and acute disease.

Leigh Ann agreed.

Comment 7 from David Walker

David questioned the studies cited to support alternative therapies.

Leigh Ann clarified that the purpose of the content is to promote a multi-disciplinary approach, specifically through collaboration across other disciplines such as oncology and natural therapeutics.

Dennis added that alternatives to antibiotics are being explored in agriculture and in Asia, in particular the study of mechanisms of pathogenesis and mechanisms of interrupting that process through alternative therapeutics.

Sam questioned why additional suggestions are being made in this chapter when it already contains recommendations. He proposed deleting the section altogether.

Leigh Ann disagreed and re-emphasized the importance of improving collaboration with industry and multi-disciplinary outreach.

Dennis commented that the content was confusing because of its placement in the same chapter as the Federal Inventory recommendations. He suggested creating a separate section for it.

Sam agreed and expressed his surprise at the appearance of this section. He also questioned the inclusion of alternative approaches.

Pat disagreed, adding that research into alternative approaches is important to patients.

The group discussed the format and intent of the Looking Forward section in the Working Group’s 2018 Report to Congress.

David noted that the 2018 Working Group Co-Chairs wrote the Looking Forward chapter of the 2018 report.

Leigh Ann stated that she understood the need to differentiate between the Looking Forward content and the Federal Inventory recommendations. She suggested including the following three focus areas in a revised Looking Forward chapter:

1. Collaboration with industry
2. Multi-disciplinary approach (including oncology)
3. Lessons learned/best practices from COVID-19

Leigh Ann added that she would be open to cutting down the content and removing the graphics discussed previously.

The Working Group agreed that Leigh Ann would revise the chapter based on this discussion, ensuring that the chapter has a clear structure and message.

The group generally agreed to keep the content on lessons learned from COVID-19, although they stressed that definitive conclusions cannot yet be drawn because of its immediacy.

Sam suggested making a clearer distinction between the Federal Inventory recommendations and the Looking Forward content.

Coop asked if there would be supporting content for the recommendations, as there is in other chapters.

Creation of a Federal Inventory Chapter

Working Group members discussed the need to develop a separate and distinct chapter devoted to the Federal Inventory recommendations and commentary.

Ben explained that during the 2018 process, the Working Group often tabled topics that did not fit into their report. Those topics, he added, were the basis of the Looking Forward section. He noted that the Federal Inventory took place in a compressed timeframe and did not require much space in the 2018 report. This time, he continued, the Federal Inventory process was more extensive and, therefore, warrants its own chapter.

Dennis agreed with Ben’s summary of events.

Pat suggested that the report include a separate chapter devoted entirely to the Federal Inventory.

David and Sam agreed.

Lunch break

After a lunch break, Jim conducted roll call (see Appendix 1 and Appendix 2: Tick-Borne Disease Working Group Members and HHS Support Staff). The meeting continued with a quorum.

Comment 8 from Angel Davey

David agreed to provided corrected wording in response to Angel’s comment.

Comment 9 from Angel Davey

Angel questioned the feasibility of an anti-tick vaccine.

David and Beto replied that it is, in fact, feasible.

Beto suggested adding after the last comma in the paragraph, “and protection against the tick itself to prevent pathogen transmission.”

Additional Comment from Beto Pérez de León

Beto also suggested adding “and the control of ticks” to the rationale for Recommendation 9.2.

Comment 10 from Eugene Shapiro

The Working Group agreed that the comment pertained to an already approved recommendation and agreed to move on.

Comment 11 from Angel Davey

Angel explained that she was simply providing information for the Working Group to consider and that no action was needed.

Comment 12 from David Walker

The Working Group agreed to keep the last sentence that had been added at the end of the chapter.

Additional Comment from Sam Donta

Sam disagreed with the rationale provided for Recommendation 9.3 and agreed to provide a rewrite.

Additional Comment from Leigh Ann Soltysiak

Leigh Ann asked about the appropriateness of capitalizing the word “IF” in the recommendation.

Pat responded that it is intended to provide emphasis.

Additional Comment from Sam Donta

Sam disagreed with the use of the phrase “beyond repeated long courses of antibiotics,” noting that “beyond” is too strong of a word. He expressed concern that the statement is anti-antibiotics.

David stated that, in addition to antibiotics, it is important to look at mechanisms and chains of events to alleviate symptoms.

Dennis agreed that the intention is not to condemn what has been done in the past, but rather to look at other things that have been hypothesized but not adequately studied.

Pat suggested changing “beyond repeated long courses of antibiotics,” to “in addition to antibiotics.”

David agreed with the change.

Sam suggested changing “therapeutic countermeasures” to “therapeutic measures.”

David and Dennis agreed that government agencies (specifically, the Biomedical Advanced Research and Development Authority) will understand the intended meaning as it is currently written.

The Working Group concluded its discussion of Chapter 9.

Chapter 1: Background Review

Led by Chapter 1 writing co-leads, Leigh Ann and David, the Working Group reviewed the chapter and discussed member feedback. The following is a summary of the Working Group’s discussion of Chapter 1.

Comment 1 from Ben Beard

Ben explained the epidemiologic meaning of the word “epidemic,” noting that it does not apply to Lyme disease. Per Pat’s request, he explained why and provided examples of diseases that are considered pandemic.

David suggested replacing the word “epidemic” with “concern.”

Comment 2 from Pat Smith

David agreed to make Pat’s suggested change.

Comment 3 from Pat Smith

Pat withdrew her comment.

Additional Comments about Table X. Tick-Borne Diseases and Conditions in the United States

When referencing the table in the preceding paragraph, Beto suggested removing the word “complete.”

David and Pat agreed.

Pat suggested including Babesia divergens and MO1 as pathogens for babesiosis.

Beto agreed. He then suggested including “of public health importance,” “zoonotic,” or “of one-health importance” in the table title.

David disagreed, stating that the Background should not be overly detailed.

David asked for confirmation that Borrelia mayonii is an etiologic agent of Lyme disease.

Ben confirmed that it is.

Sam, Kevin, and Ben agreed that the source information for the table should be changed to say “derived from.”

Comment 4 from Ben Beard

Ben stated that he had not heard of Alpha-gal Syndrome being associated with vectors other than ticks.

Leigh Ann commented that the topic had been discussed by the Alpha-gal Syndrome Subcommittee.

Angel checked the subcommittee’s report and commented that chiggers have been identified as a possible vector for Alpha-gal Syndrome.

Ben explained that there is some uncertainty about the exact vector and suggested changing the language in the table to “associated with ticks and chiggers.”

Leigh Ann agreed.

Comment 5 from Ben Beard

Ben explained that the figure (entitled “Figure X. Annual Reported Cases of Tick-Borne Diseases in the United States”) is from CDC and asked that it be cited as such.

David agreed.

Comment 6 from Pat Smith

Pat asked that the language be clarified to state that one tick bite can cause more than one disease.

David added that someone exposed to one tick bite may also be exposed to more than one tick.

The group generally agreed to add that “one tick bite can result in more than one pathogen being transmitted.”

Comment 7 from Pat Smith

Pat suggested changing “advisory committee” to “working group” to match the language in the 21^st Century Cures Act.

There was general agreement to make the change.

Comment 8 from Pat Smith

Pat commented that the term “industry representative” should not be used to describe a Working Group member because the category is not included in the 21^st Century Cures Act. She expressed concern about setting a precedent for industry representation on the 2022 Working Group.

Leigh Ann asked DFO Jim Berger for clarification on the language.

Pat read the designations outlined in the 21^st Century Cures Act.

Jim confirmed that what Pat read is correct.

The Working Group reviewed its membership and discussed ways to revise the language.

Leigh Ann disagreed that industry representation should be excluded, citing the prior discussion about the importance of improving collaboration and outreach with industry.

The group decided to change “industry representative” to “patient (recovered),” although Leigh Ann noted that she would need to reflect on it further.

Comment 9 from Angel Davey

Angel suggested revising language that refers to the Working Group’s 2018 Report to Congress, noting that she would email the new language to the group following the meeting.

Comment 10 from Leigh Ann Soltysiak

The Working Group agreed that Leigh Ann’s comment had already been addressed in the chapter language and moved on.

Comment 11 from Leigh Ann Soltysiak

Leigh Ann suggested changing “sections” to “chapters,” ensuring consistency throughout the report.

Beto and Gene agreed.

The Working Group concluded its discussion of Chapter 1.

Chapter 2: Methods Review

The Working Group reviewed the chapter and discussed member feedback. The following is a summary of the Working Group’s discussion of Chapter 2.

Comment 1 from Leigh Ann Soltysiak

Leigh Ann suggested clarifying the language that refers to the Working Group and its subcommittees, suggesting it may be difficult for the reader to follow.

David suggested revising the first sentence to say, “eight subcommittee reports” (rather than “the subcommittee reports”).

Leigh Ann agreed to the change.

Comment 2 from Pat Smith

Pat suggested changing “develop this report” to “developing the Tick-Borne Disease Working Group 2020 Report to Congress.”

Leigh Ann agreed.

Comment 3 from Pat Smith

Pat recommended that it be clarified whether or not the Working Group co-chairs (Leigh Ann and David) participated on subcommittees.

Leigh Ann explained that they did, noting that the language would be revised for clarity.

Comment 4 from Pat Smith

Pat recommended adding “and patient needs” after “relevant science.”

Leigh Ann agreed.

Comment 5 from Pat Smith

Pat asked that the description of how the subcommittees presented their findings to the Working Group be clarified. She added that the term “reviewed” should be replaced with “presented.”

David suggested adding that the Working Group “voted to approve, modify, or reject” the subcommittees’ recommendations.

Leigh Ann agreed that the changes should be made.

Comment 6 from Ben Beard

Ben questioned the statement that the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA) conduct human surveillance.

Dennis (NIH representative) and the NIH alternate representative, 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, confirmed that they do not have a designated surveillance program and only conduct minimal surveillance research if an individual grant calls for it.

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, confirmed that FDA does not do human surveillance.

There was general agreement to remove references to NIH and FDA in the statement in question.

Additional Comment from Pat Smith

Pat suggested removing the statement that the Department of Defense (DoD) has a strategic plan to address tick-borne diseases. She added that she was only aware of the Congressionally Directed Medical Research Programs (CDMRP) related to tick-borne diseases.

Angel agreed, noting that she was not aware of a DoD strategic plan.

Pat reiterated that the reference to DoD could be removed or the CDMRP initiative could be added.

Comment 7 from Pat Smith

Pat asked where the Federal Inventory process would be explained.

David replied that it will be included in the Methods section.

Comment 8 from Pat Smith

Pat explained that the following content had been removed from the chapter without tracked changes and asked that it be reinstated:

Based on the Federal Inventory results, the Working Group identified the following needs and gaps in research.

• Update efforts on tracking and investigating the prevalence of Lyme and other TBDs, for example, within DHA, and make the education modules available to practitioners
• Increase NIH funding to support research on Lyme disease (particularly persistent Lyme disease) and other tick-borne diseases

Leigh Ann asked why results are being included in the Methods chapter.

Pat replied that the Federal Inventory results content can be moved to the new Federal Inventory chapter as long as the abovementioned content is included as well.

Additional Comment from Sam Donta

Referring to a statement about research that NIH currently supports, Sam expressed concern that the reader might conclude that needed research is already being done. He added that NIH does not currently support many clinical studies.

David suggested rephrasing the language to say that NIH supports basic and “some” clinical studies.

Dennis concurred that clinical research studies supported by NIH are proportionally lower than basic research studies.

Pat agreed with David’s suggested language.

Comment 9 from Leigh Ann Soltysiak

Leigh Ann stated that it is incorrect to say that the Working Group “solicited input from the public,” noting that the public proactively provides comments.

Pat recommended rephrasing the sentence to say that the Working Group “provided opportunity for public comment.”

Leigh Ann agreed with the change.

Comment 10 from Leigh Ann Soltysiak / Creation of a Public Comments Chapter

Leigh Ann questioned why the Public Comments discussion is included in the Methods section, although she noted that this was the precedent set by the Working Group’s 2018 Report to Congress.

Sam highlighted the importance of including the key themes identified by public commenters and recommended creating a separate chapter devoted entirely to public comments. He added that a reference to the new Public Comments chapter could be added to the Methods chapter.

Leigh Ann replied that the key themes would need to be summarized and added to the new chapter.

Pat pointed out that the Public Comments Subcommittee has already generated summaries. She also suggested providing a link to the Working Group’s website where public comments related to public meetings are housed.

The group discussed how the key themes are categorized. They expressed the importance of presenting key themes evenly, without giving some comments more weight over others, and of meeting Federal Advisory Committee Act (FACA) requirements.

Kaye Hayes, MPA, Alternate Designated Federal Officer, Tick-Borne Disease Working Group; Executive Director, Presidential Advisory Council on HIV/AIDS; Principal Deputy Director, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, HHS, commented that the Working Group is required to provide opportunity for the public to make comments at all public meetings. However, she added, the Working Group can decide how to present that information in its reports to Congress.

Angel stated that she would be open to creating a new chapter, adding that the she and the other chapter co-leads may need to add additional themes for a more balanced presentation.

Leigh Ann agreed that it will be challenging to prioritize them. She stated that the co-leads would take the existing content, review their public comments summaries, and revise the content accordingly for discussion at the next meeting.

The Working Group concluded its discussion of Chapter 2.

Table of Contents and Title Page Review

Led by contractor Jennifer Gillissen, Kauffman and Associates, Inc., the Working Group reviewed and discussed the Table of Contents and Title Page for the Tick-Borne Disease Working Group 2020 Report to Congress.

Jennifer showed the 2018 Table of Contents, noting that the 2020 version will follow a similar format. She added that the updated Table of Contents will include the two new chapters (Federal Inventory and Public Comments) discussed today. She asked members to consider whether or not they would like to include an appendix for acronyms and abbreviations.

David responded that, if there are not a lot of acronyms, it may not be necessary to include an appendix for them.

Leigh Ann and Pat noted that it will be important to have an appendix for acronyms and abbreviations.

The group agreed to remove Appendix C (containing images relevant to the 2018 Report to Congress) and Appendix D (Federal Inventory) because the new report will contain a chapter devoted to the topic.

Jennifer stated that there will be an appendix for the 21^st Century Cures Act, the Working Group’s Charter, and the report references. She added that the Table of Contents would be revised and provided to the Working Group prior to the next public meeting.

Beto suggested adding an appendix to recognize the contributions of the subcommittee members.

Sam, Ben, and David agreed.

Jennifer clarified that the new subcommittee appendix would be placed after Appendix A (Tick-Borne Disease Working Group) and Appendix C (Acronyms and Abbreviations).

There was general agreement.

Jennifer asked if the Working Group members agreed with the disclaimer at the bottom of the Table of Contents.

There was general agreement.

Pat suggested changing “the report” to “this report.”

Jennifer presented the Title Page in pdf format, highlighting the disclaimer at the bottom and noting that changes that had been made based on member feedback received by email prior to the meeting. She explained that the Working Group could approve it at today’s meeting, or she could send it to the Working Group for continued review.

Leigh Ann asked that Jennifer send the Title Page for continued review.

Sam suggested that the path in the photograph be wider.

Wrap-up

Leigh Ann asked the Working Group if there were any final comments.

Prompted by Ben, Leigh Ann reiterated that the next public meeting would be held on October 27, 2020. She added that the November and December meeting dates were yet to be determined.

Pat asked if there was a preliminary agenda available for the October meeting.

Leigh Ann responded that the draft agenda is in development and would be provided to members as soon as it was available.

David and Leigh Ann thanked members for their hard work. They noted that on Day 2, the Working Group would review revised chapters discussed at the July meeting.

Adjournment of Day 1

The meeting was adjourned at 3:11 pm Eastern.

Welcome and Roll Call: Day 2

Designated Federal Officer James (Jim) Berger called the second day of Meeting 15 to order and welcomed all meeting attendees. Jim then conducted roll call (see Appendix 1 and Appendix 2: Tick-Borne Disease Working Group Members and HHS Support Staff). The meeting started with a quorum.

Co-Chair Welcome and Agenda for Day 2

Co-chairs David and Leigh Ann welcomed Working Group members and the public.

David outlined the Day 2 meeting agenda, explaining that the Working Group would be reviewing and discussing Chapters 3, 4, 5, 6, and 7, which were revised based on discussions that took place at Meeting 14.

Chapter 3: Tick Biology, Ecology, and Control Review

Led by writing co-leads Kevin Macaluso and Beto Pérez de León, the Working Group discussed revisions to Chapter 3. The following is a summary of their discussion.

Comment 1 from David Walker

The Working Group agreed that because the comment pertained to a recommendation, it would be disregarded.

Comment 2 from David Walker

Kevin agreed to implement David’s suggestion to use the present tense.

Comment 3 from David Walker

Kevin agreed to replace the word “however” with “moreover.”

Comment 4 from David Walker

Ben agreed to provide a revised version of Figure 1 (“Increasing Number of Tick-borne Pathogens”) with colors that are more easily distinguished from one another.

Before proceeding to comment 5, Leigh Ann asked Kevin and Beto if they had made the changes requested at the July meeting. Kevin responded that he and Beto had made the changes, but they did not provide replies in the margin because they were under the impression that replies would be discussed at today’s meeting. The group then proceeded to the next comment.

Comment 5 from David Walker

Kevin explained that the CDC website lists B. mayonii as a cause of Lyme disease.

David stated that Figure 1 could, therefore, remain as is.

Sam asked why B. miyamotoi is not listed as a pathogen that causes Lyme disease.

Ben replied that it is in a different group of spirochetes and explained the taxonomic and genetic differences.

Comment 6 from David Walker

In response to David’s comment, Kevin stated that the language is intended to encompass both environmental change and habitat variability.

David, Kevin, and Sam discussed ways to wordsmith the statement in question and decided to replace “climate variability” with “climate and environmental change.”

Comment 7 from David Walker

Kevin and Beto agreed to rearrange the bullet points, so that “Prevent unacceptable levels of pest damage” is at the bottom of the list.

Comment 8 from David Walker

Kevin agreed to replace “vectors” with “hosts.”

Comment 9 from David Walker

David pointed out that during Day 1 of Meeting 15, the Working Group agreed to place CDC’s updated Ixodes map in Chapter 3 (as opposed to Chapter 8).

Comment 10 from Leigh Ann Soltysiak

There was agreement to embed the image of the lone star tick in the distribution map (entitled “Figure 5. Lone Star Ticks on the Rise”).

Comment 11 from Ben Beard

Kevin stated that he and Beto agreed with Ben’s comment and will consolidate the bullet points as suggested.

Comment 12 from David Walker

Kevin commented that he and Beto agree with David’s comment and will make the suggested correction.

Additional Comment from Pat Smith

Pat stated that a correction was needed in the paragraph preceding Recommendation 3.3. She explained that, based on an article she had read with information from the Texas Animal Health Commission, cattle tick fever (the disease) had not been eradicated. She suggested replacing “eradicated” with “ameliorated.”

Beto clarified that the ticks have spread, but there have been no new outbreaks of the disease.

Additional Comment from Beto Pérez de León

Beto proposed that the following statement be added to the end of the sentence immediately preceding Figure 2 (“One Health Approach): “such as the CDC-led effort that resulted in the discovery of nootkatone, which was registered by the EPA to repel and kill ticks (CDC, 2020).”

Pat agreed that the insertion is important to include in the report, noting that the information is recent and relevant.

David and Leigh Ann asked members whether or not it is appropriate to bring up new information. Leigh Ann asked Alternate Designated Federal Officer Kaye Hayes for clarification.

Kaye replied that it is up to the Working Group to determine the process, adding that it would be beneficial to be consistent.

Beto stated his understanding that certain aspects of the chapters cannot be changed, then asked if there is flexibility to add new information or adjust the content as needed.

Kevin explained that adding the information about nootkatone is timely and strengthens the chapter. He asked if a vote was needed.

Beto reiterated the proposed language and citation.

Pat stated that if new material has come to light or there is an error in chapter content, it should be addressed by the Working Group. She highlighted that EPA’s registration of nootkatone is an important development in the prevention of tick-borne diseases.

David motioned to add the language proposed by Kevin and Beto.

 Pat seconded the motion.

Vote

Twelve members voted yes to insert the following language at the end of the sentence preceding Figure 2: “such as the CDC-led effort that resulted in the discovery of nootkatone, which was registered by the EPA to repel and kill ticks (CDC, 2020).” Two members were absent. The motion passed.

Kevin concluded the review of Chapter 3 by stating that he and Beto would work with the support writer to finalize the chapter based on the today’s discussion.

Chapter 4: Clinical Manifestations, Diagnosis, and Diagnostics Review

Led by writing co-leads Sam Donta and Todd Myers, the Working Group discussed revisions to Chapter 4. The following is a summary of their discussion.

Sam began by explaining that he and Todd had addressed comments about phrases such as “Lyme disease,” persistent Lyme disease,” and “persistent symptoms of Lyme disease.”

Comment 1 by David Walker

David made a motion to replace the word “likely” with “possibly” in the second paragraph under the heading “Lyme disease.”

Sam defended the use of the word “likely.”

Todd commented that the statement should be rephrased to avoid implying that the conclusions drawn from the animal studies can be applied to humans.

Sam replied that the non-human primate models support that application. He added that the group had already discussed the terminology during the previous meeting. Sam then proposed that he and Todd work together to come up with a sentence that would be more acceptable to the group.

Dennis suggested a statement of hypothesis, eliminating the terms “likely” and “possibly.”

Leigh Ann commented that, despite being discussed at the previous meeting, the wording was not resolved in the chapter.

Todd replied that he and Sam would work together to revise the wording.

Dennis suggested phrasing to the following effect: “Evidence continues to gather to support the hypothesis that…”

David and Sam disagreed on the use of animal models as support for persistence infection in humans.

Leigh Ann suggested that the group move on and allow the writing co-leads to revise the statement.

Dennis stated that he would be willing to work with the co-leads to revise the language.

Additional Comment from Angel Davey

Regarding Table 1 (entitled “Clinical Symptoms Associated with Lyme Disease and Lyme-like Illnesses”) Angel asked if some of the initial concerns (expressed in July 2020) about the accuracy of the table could be addressed by incorporating some of the key overlapping symptoms into the text, then removing the table altogether.

Sam replied that he welcomed suggestions from Angel for revising the text. He added that the simplest approach would be to leave the table as is.

Kevin asked what had been changed in the table.

Sam replied that the title had been changed; there were clarifications about Gulf War Veterans’ illness; and other edits were made to reflect the requested changes.

The group reviewed other comments made in July about the table. Sam concluded that the comments had been addressed and suggested that the group move on.

Comment 3 from Eugene Shapiro

Kevin asked if Gene’s comment from July (regarding host inability to clear infection) had been addressed, noting that there was no change in the chapter text.

Sam responded that the statement in question was left as is.

David disagreed with the statement.

Sam agreed to remove it.

Comment 4 from Leigh Ann Soltysiak

Leigh Ann and Angel discussed the acronym for Alpha-gal Syndrome and agreed that the convention would be to use all capital letters (“AGS”).

Comments 5 and 6 from the Support Writer

The Working Group acknowledged the need for references for the information provided about rickettsial diseases, specifically the case fatality rates of Rocky Mountain spotted fever.

Ben commented that he had supplied a CDC link with publicly available information and suggested that David provide published references.

Comment 7 from David Walker

David explained his comment about elevated liver functions and stated that the statement in the chapter could be left as is.

Comment 8 from David Walker

Sam and Todd agreed to replace “diagnostic” with “diagnostics.”

Comment 9 from David Walker

The group reviewed David’s comment about the inaccurate perception of human monocytic ehrlichiosis and agreed to leave the text as is.

Comment 10 from David Walker

Sam agreed to replace “function” with “injury.”

Additional Comment from Pat Smith

Pat pointed out that a reference is required in the second paragraph under the heading “Ehrlichiosis and Anaplasmosis.”

Additional Comment from Ben Beard

Ben noted that he provided a reference for the first sentence under the heading “Emerging Tick-Borne Pathogens.”

The Working Group concluded its discussion of Chapter 4.

Chapter 5: Causes, Pathogenesis, and Pathophysiology Review

Led by Angel Davey, the Working Group discussed revisions to Chapter 5. The following is a summary of their discussion.

Comment 1 from Angel Davey

Angel stated that she would like to go through the other comments in the chapter first, then return to the topic of Table 5.1 at the end of the discussion.

Comment 2 from David Walker

Angel agreed with David’s editorial suggestion.

Comment 3 from Eugene Shapiro

In response to Gene’s comment, Angel asked the group if they agreed with the following revised text: “Rapid, accurate diagnostic tools are critical for…”

David agreed.

Additional Comments from Angel Davey

Angel pointed out that, in response to an earlier suggestion from David, the following text was stricken: “Further, tick-borne infection may weaken a patient’s immune system, increasing their risk of developing other infections (e.g., mycoplasma pneumoniae) and affecting their response to treatment.”

She added that it was replaced with the following statement: “Studies of human serum (Chiao, et al., 1994; Garg, et al., 2018) and studies carried out in mouse models (Elsner et al., 2015) further suggest that the ability of tick-borne infection to suppress, subvert, or modulate the host immune system may affect response to treatment and also potentially increase the risk of developing other infections (Garg, et al., 2018).”

Angel then asked if the Working Group agreed with the change or if further discussion was needed.

David and Sam agreed with the change.

Before moving on to the next comment, Angel pointed out two revisions from Ben Beard that she had accepted.

Comment 4 from David Walker

Angel agreed with David’s editorial suggestion.

Comment 5 from David Walker

Regarding David’s suggestion to replace the word “likelihood” with “possibility,” Angel proposed rephrasing the statement so that it refers to a hypothesis, similar to Dennis’s suggestion earlier in the discussion.

Sam agreed.

Additional Comments from Angel

Before moving on to the next comment in the margin, Angel identified several other revisions that had been made in response to comments made in July.

Angel brought up the topic of animal studies and mouse models, discussed in the rationale for Recommendation 5.2. Dennis, Todd, Sam, and Kevin made suggestions for revising the material.

The consensus was to keep the following statement: “This emphasizes the need for further research to assess the potential linkage between observations from animal studies and human disease and better understand the role of bacterial persistence in the pathogenesis of Lyme disease. A better understanding of both bacterial factors and immune responses is essential for improved clinical management of patients with persistent symptoms associated with Lyme disease.”

Comment 6 from Leigh Ann Soltysiak

Angel and Leigh Ann agreed to change “VlsE” to “VlsE protein.”

Comment 7 from David Walker

Angel agreed to implement David’s correction related to the dura mater.

Additional Comment from Angel Davey

Leigh Ann pointed out revisions to the paragraph immediately preceding Recommendation 5.3 and asked if discussion was needed.

David agreed with the revisions.

Before going back to discuss comment 1, Angel commented that the references in the chapter will need to be updated.

Return to Comment 1 from Angel Davey

Angel explained that she and writing co-lead Scott Palmer Commins, BS, MD, PhD, Associate Professor of Medicine & Pediatrics, University of North Carolina; Member, UNC Food Allergy Initiative, Thurston Research Center, had drafted a table entitled “Table 5.1. Causes, Pathogenesis, and Pathophysiology of Tick-borne Diseases,” which they proposed adding to the chapter. She asked for the graphic to be projected on screen, so members could review and discuss it

Leigh Ann responded that she is in favor of including graphics to support the text. She added that it may be helpful for readers who are unfamiliar with the many tick-borne diseases.

Todd agreed.

David commented that it will be difficult to accurately describe the pathogenesis of all of the diseases. He noted that the information for rickettsiosis and ehrlichiosis is incorrect, adding that the pathogenesis column would need further revision.

Sam agreed with David. He stated that it will be difficult to accurately describe both pathogenesis and pathophysiology, which would limit the value of the table.

Angel asked if it would be valuable to show just the first three columns (excluding pathogenesis and pathophysiology).

Sam agreed to that possibility but questioned whether it should be featured in Chapter 3 or Chapter 8.

Ben cautioned the group about including too much detail and asked whether or not the information will help Congress and HHS analyze the problem.

Pat agreed. She pointed out missing information, noting that the table may be too complicated to add value.

Angel reflected that, other than Leigh Ann, the group seemed to think the table should not be included. She said she would follow up with Scott Commins (absent from the meeting) about it.

Leigh Ann thanked the group for considering the inclusion of the table.

The Working Group concluded its discussion of Chapter 5.

Chapter 6: Treatment Review

Led by writing co-leads Dennis Dixon and Sam Donta, the Working Group discussed revisions to Chapter 6. The following is a summary of their discussion.

Comment 1 by David Walker

Sam agreed with David’s suggestion to remove tick-borne relapsing fever from the sentence.

Comment 2 from Ben Beard

The group discussed Ben’s suggestion to remove Table 6.1 Current Treatment Options and Management Strategies for Tick-borne Diseases. Sam, Dennis, David, and Kevin agreed that the table is superfluous and does not add value to the chapter.

Comment 3-6 from Leigh Ann Soltysiak

Comments 3 through 6 pertain to the table to be removed (Table 6.1), so the Working Group disregarded them and moved on.

Comment 7 from Leigh Ann Soltysiak

The Working Group considered the revision that had been made in response to the July (Meeting 14) discussion.

Pat questioned the deletion of the statistic that “10-20% of patients with Lyme disease suffer from relapses and persistent symptoms,” and recommended that it be reinstated, adding that there are references available to support it.

David and Sam commented that the statistic has been used elsewhere in the report; however, Sam noted that it bears repeating because it was referenced in a separate chapter.

There was general consensus to replace the word “some” with “10 to 20% of patients.”

Leigh Ann asked if the terms “antibiotics” and “antimicrobials” are being used interchangeably in the report.

Sam, David, and Leigh Ann generally agreed to use “antibiotics” consistently throughout the report.

Comment 8 from Ben Beard and Comment 9 from Angel Davey

Sam agreed with Ben’s comment that the information on management of Alpha-gal Syndrome was too detailed and agreed to replace it with Angel’s suggested text, as follows: “There are a number of considerations in the management of AGS, including avoidance of mammalian meat, dairy products in some cases, non-meat non-dairy food products such as gelatin, as well as certain medical products that may contain mammalian-derived components.”

Comment 10 from David Walker

Sam agreed with David’s suggestion to remove the reference to children in the following sentence: “This gap in the spectrum of drugs that can be used complicates treatment for children and pregnant women.”

Additional Comment from Pat Smith

Pat asked to go back to look at the first sentence under the heading “Rickettsial Diseases.” She commented that fatality rate for Rocky Mountain spotted fever (“more than 20%”) is not supportable, adding that recent CDC data should be used instead.

David replied that the case fatality rate is for untreated, accurately diagnosed people and reflects data from a study conducted by R. Parker between 1939 and 1945, during the pre-antibiotic era.

Sam commented that the statement requires a reference.

Pat added that a current reference is needed.

Todd and David responded that references are available and can be supplied.

David, Ben, and Sam emphasized the severity of the disease. Ben highlighted the high case fatality rates in Arizona and New Mexico, noting that there is ambiguity related to diagnostics and geography.

Leigh Ann suggested articulating the case fatality rate as a gap in knowledge.

David replied that rates are known. He highlighted current case fatality rates in other countries.

Kevin suggested focusing on rates in regions where there have been recent outbreaks.

David agreed.

Ben agreed to help come up with clarifying verbiage about Rocky Mountain spotted fever case fatality rates.

Comment 11 from Leigh Ann Soltysiak

Sam agreed to revise the statement in question using Leigh Ann’s proposed language.

Comment 12 from Angel Davey

Sam agreed to provide necessary references.

Comment 13 and 14 from David Walker

Sam agreed to address David’s editorial suggestions.

Additional Comment from Pat Smith

Pat pointed out that a reference is needed for the Powassan virus case fatality rate (10-15%).

Sam agreed to provide it.

Lunch Break

After a lunch break, Jim conducted roll call (see Appendix 1 and Appendix 2: Tick-Borne Disease Working Group Members and HHS Support Staff). The meeting continued with a quorum.

Chapter 7: Clinician and Public Education, Patient Access to Care Review

Led by writing co-leads Scott (Coop) Cooper and Pat Smith, the Working Group discussed revisions to Chapter 7. The following is a summary of their discussion.

Comment 1 from David Walker

In response to David’s comment that the chapter content does not support the recommendations, Coop replied that he and Pat rebalanced and revised the chapter. He commented that the title includes patient access to care; the education component applies primarily to Lyme disease; and Chapter 7 is the only one that devotes considerable space to the patient experience. He added that coverage of the patient perspective will be important to the intended audience.

Comment 2 from Eugene Shapiro

The Working Group acknowledged that Gene’s comment related to a recommendation, and therefore, no changes could be made.

Comment 3 from Angel Davey

Angel asked whether or not the comments on cost made during the previous meeting are reflected in the revisions.

Coop responded that cost has a significant impact on patient access to care; therefore, the section was left intact.

Comment 4 from Leigh Ann Soltysiak

In response to Leigh Ann’s suggestions for the section on cost, Coop responded that the content is simple and clear as is.

Comment 5 from David Walker

In response to David’s question about the incidence of post-treatment Lyme disease syndrome (PTLDS), Coop replied that the paragraph does not pertain to PTLDS.

David asked if 35% is correct, noting that the percentage is higher than the statistic given in the previous chapter.

Gene added that the previous chapter (Chapter 6: Treatment) gave 10-20% as the percentage of people with persistent symptoms.

Pat replied that the statistics come from two different studies, adding that she could include the Marquez study as well.

David, Gene, Pat, and Dennis discussed how patients were enrolled in those studies and whether or not they were treated for Lyme disease during the acute phase of infection.

Gene suggested including a range that encompasses available information from the different studies.

Pat and Coop agreed to include the range of percentages from available studies.

Comment 6 from Eugene Shapiro

In response to Gene’s comment, Coop stated that the content had been discussed at the previous meeting. He clarified that it was based on six peer-reviewed articles and two white papers, and all references are included.

Gene and David commented that patients who self-report may not be considered confirmed cases and including them in treated patients could be misleading.

Pat, Coop, and Sam described the large patient registry from which the data are derived and expressed their view that such data are valid.

Leigh Ann suggested adding the word “self-reported” to enhance clarity.

Dennis agreed with Leigh Ann and emphasized the importance of capturing the patient experience in the chapter. He suggested introducing the content with an explanation that registries were used to capture the information presented.

Pat asked whether or not NIH includes similar qualifiers when citing registry data.

Dennis replied that registries usually explain methods. He suggested describing the importance of registries and stating who can enter the registry and how the information was collected.

Pat agreed to add the qualifer. She commented that such qualifiers appear to be only needed for Lyme disease.

Leigh Ann stated that the qualifier provides clarity and would enhance the value of the information.

Coop replied that he and Pat would work on revising the language based on Leigh Ann’s and Dennis’s suggestions.

Comment 7 from David Walker

David questioned the revisions pertaining to the case fatality rate of human monocytic ehrlichiosis, noting that Rocky Mountain spotted fever occurs in 48 states and ehrlichiosis has spread as far as Maine.

Coop and Pat explained the intended meaning of the statement, explaining that the section is about tick-borne diseases in general rather than those specific diseases. He added that the overlap between diseases is discussed in the paragraph.

David accepted their explanation.

Comment 8 from David Walker

Coop agreed with David’s comment about human granulocytic anaplasmosis in North Carolina and noted that he and Pat had removed the references to it.

Comment 9 from David Walker

In response to David’s comment about Ehrlichia muris eauclairensis, Coop agreed and stated that he and Pat had updated the content with data from CDC.

Comment 11 from David Walker [Note that comments 10 and 11 were discussed in reverse order]

In response to David’s comment about reported cases of ehrlichiosis and anaplasmosis, Coop responded that the intention was not to portray the diseases as rare. He clarified that the paragraph had been revised to show the rise in the number of cases according to CDC data. He noted that he would include additional information with references, if they are available.

David agreed to provide a reference indicating that the number of E. chaffeensis cases is 10 to 100 times greater than the passively reported data.

Pat suggested adding elsewhere in the chapter that there are places in the country where Lyme diseases is higher than in other areas.

Comment 10 from Kevin Macaluso

In response to Kevin’s comment about the subjectivity of the statement, Coop explained that phrasing comes directly from CDC’s website.

Kevin stated that the decline from 2017 to 2018 is identified for anaplasmosis; however, the decline in Lyme disease cases that occurred the same year is not mentioned in the table at the start of the chapter.

Coop reiterated that the information was presented as such on CDC’s website.

David and Sam commented that they do not think the incidence is decreasing. Sam noted that reporting fatigue may play a role in underreporting.

Pat explained how they had originally obtained the data from the Ehrlichiosis and Anaplasmosis Subcommittee Report and then revised to reflect more accurate information obtained from the CDC website.

Coop stated that they would consider removing “substantially lower.”

Ben explained the fluctuations in reported cases each year and stated that the overall trend is a significant increase in ehrlichiosis and anaplasmosis cases over the past 15 years. He cautioned the group in how the data are interpreted. He added that this is the case for Lyme disease and spotted fever rickettsia as well. He suggested highlighting the trend rather than the change in case numbers from year to year and pointed members to Table 1 in the SharePoint folder for Chapter 8, which shows the case numbers for all tick-borne diseases from 2004 to 2018.

Pat, Coop, and David agreed with Ben’s suggestion for revising the material.

Comment 12 from Eugene Shapiro

Coop stated that Gene’s comment was in response to David’s comment from May 2020, adding that it had already been addressed.

Comment 13, 14, and 15 from Eugene Shapiro

In response to Gene’s comment regarding clinical trials, Coop stated that the issue had already been discussed and there was agreement that studies from other countries would not be included. He added that the information provided is based on the studies cited.

Gene commented that the presentation could be more balanced.

Pat replied that she and Coop had already revised the content based on previous suggestions from Dennis.

Gene disagreed with the way the results of the NIH studies were portrayed in the text and commented that, in his view, the current version of the content does not accurately reflect results of available clinical trials. He stated that he would vote against the content as written and would consider writing a minority report later.

Pat and Coop explained that they had revised the content based on the discussion at the previous meeting, acknowledged the differences of opinion, and included studies with opposing views.

Dennis stated that the content was significantly improved from the previous version and suggested rephrasing some of the statements to be less contentious.

Additional Comment from Leigh Ann Soltysiak

Also regarding the section on clinical trials, Leigh Ann commented that the following statement is subjective: “Such trials typically require industry funding, but the pharmaceutical industry has generally not been interested in funding Lyme disease clinical treatment trials since treatment with generic antibiotics, as has become the norm, does not provide adequate financial incentives.” She suggested either further explaining the hypothesis, removing it, or ending with a statement that there is not adequate treatment.

Pat commented that, in her experience, companies have not shown interest in developing treatments for tick-borne diseases.

Leigh Ann acknowledged that to her knowledge there has not been investment from the pharmaceutical industry in Lyme disease treatment trials and suggested including that in the report as a gap. She reiterated that she found the statement, as written, to be inaccurate and subjective. She suggested highlighting patients’ need for treatment as a way to prompt interest from the health care industry (including pharmaceutical companies) rather than stating that pharmaceutical companies are not interested in investing.

Pat asked Dennis to provide insight into what NIH can do to encourage the development of treatment modalities.

Dennis responded that while NIH does not control the approach of the pharmaceutical industry, the agency encourages and incentivizes the development of better countermeasures—prevention, diagnosis, treatment—for tick-borne diseases.

Sam commented on the challenges of developing new antibiotics in the absence of markers for measuring patient symptomatology.

Dennis described some of the recent market failures of new antibiotics for drug resistant infections, highlighting the overall antibiotics crisis. He noted that some smaller companies have shown interest in opportunities to develop Lyme disease treatment while others have not.

Sam stated that his understanding of this section’s purpose is to inform the reader that the available clinical trials have limited information. He added that there is perhaps too much detail about treatment, which is already covered in the chapter devoted to treatment (Chapter 6).

Pat replied that the level of detail would remain; however, she would be open to rephrasing the last sentence.

Pat, Leigh Ann, and Sam discussed potential language. Pat suggested stating that the pharmaceutical industry is not interested in funding new antibiotics for infectious diseases, including Lyme disease. Sam countered that new antibiotics are being developed for some infections. Leigh Ann expressed concern that the financial incentive language could be misinterpreted.

Pat agreed to work with Coop on the revision.

Comment 16 from David Walker

Referencing David’s comment about “the state of the science for treating persistent Lyme disease patients,” Coop stated that the statement would remain as is.

Comment 17 from David Walker

In response to David’s comment about the mechanisms of post-treatment Lyme disease syndrome, Coop explained that the statement in question is rhetorical and points to the need for more research.

Comment 18 from Leigh Ann Soltysiak

In response to Leigh Ann’s comment about the lack of funding by industry for Lyme disease trials, Coop responded that the statements are factual, drawn from available evidence, and will remain intact.

Comment 19 from Eugene Shapiro

Coop stated that the topic of the two sets of guidelines has been discussed and pointed out the references used to support the statements in question.

Comment 20 from Eugene Shapiro

In response to Gene’s recommendation to delete Table 3 Comparison of IDSA and ILADS Guidelines, Coop responded that the section has been discussed and the content revised. He added that he did not think there was anything else that could be done.

Gene asked for clarification of “research-based diagnosis.”

Pat stated that the IDSA guidelines adhere to strict criteria and are not oriented to a clinical diagnosis.

Sam proposed using a term other than “research,” for example “laboratory” or “clinical.”

David recommended replacing “research-oriented diagnosis” with “evidence-oriented, including clinical diagnosis.”

Pat stated medicine is not an exact science and often requires patient-oriented criteria.

The group further debated the two sets of guidelines. Different interpretations of the guidelines were expressed. While David explained that the IDSA guidelines apply to all patients (that is, patients with acute illness and patients with persisting symptoms) and highlight the need for prompt diagnosis and treatment with the use of clinical judgment, Pat insisted that the IDSA guidelines does not allow shared decision-making and clinical judgement. The group did not reach a consensus regarding how to move forward.

Sam suggested changing the title of the table to “Comparison of Guidelines for Persisting Symptoms of Lyme Disease.” He reiterated his suggestion to replace the word “research” with “laboratory” or “clinical.”

Pat and Coop agreed to retitle the table and consider the terms used within the table.

Kevin suggested supply references for the terms used in the table to clarify the information and support it.

Pat stated that they would consider the suggestion.

Comment 21 from David Walker

In response to David’s comment about the relevance of the section on shared decision-making, Coop stated that the content had been discussed previously and clarified that shared decision-making is a relatively new concept that is not always practiced in medicine.

David replied that shared decision-making has been part of expected medical practice for over 30 years.

Coop questioned whether or not it was commonplace.

David asked how the content relates to the chapter.

Sam highlighted the following statement from the chapter: “Shared decision-making assumes greater importance when the evidence base is weak.” He agreed with Coop that shared decision-making is not as commonplace in medicine as it should be.

Coop pointed out that shared decision-making is part of the Recommendation 7.1.

Pat explained how shared decision-making relates to patient care and agreed with Coop and Sam that it is not practiced as often as it should be for all patients with tick-borne disease.

David, Pat, and Coop continued to discuss the relevance and length of the content.

Leigh Ann commented that shared decision-making applies to Recommendation 7.2, which is also about provider training.

Dennis stated that he struggles with the concept of accessing care. He offered a personal anecdote related to the concept and asked if access to care is the correct term.

Pat replied that the term is correct and explained how it relates to his situation.

Responding to Dennis’s question, Leigh Ann suggested that the reader may not know what access to care means and proposed other possible ways to think about access to care (for example, access to trained providers and access to treatment that can be reimbursed). She asked if that the broader picture could be depicted in the section in question.

Coop agreed that access to care is a short-hand term for a multi-faceted concept. He noted that the concept of shared medical decision-making is equally complex. He concluded that the section is long and detailed in order to address some of the nuances.

Comment 22 from Angel Davey

Regarding Angel’s comment that there may be overlap between the rationale for Recommendations 7.2, 7.3, and 7.4, Coop responded that he thinks the differences will be clear to the reader. He noted that the rationale for Recommendations 7.3 and 7.4 comes from the relevant subcommittee reports and that he and Pat would welcome additional information to support them.

Pat asked what, specifically, Angel was requesting.

Angel suggested including information that distinguishes education about other tick-borne diseases from Lyme disease, noting that the coverage is disproportional. She added that, through public comments, patients and advocates have been calling for more provider training for other tick-borne diseases such as Rocky Mountain spotted fever.

Pat explained the level of detail for Lyme disease and replied that she and Coop could add more information for Recommendations 7.3 and 7.4.

Coop agreed, noting that the recommendations could reinforce each other.

David commented on some of the differences between the diseases listed in Recommendations 7.3 and 7.4, concluding that it is logical to distinguish them. He suggested talking about babesiosis separately because it is better understood than the other diseases listed in Recommendation 7.4.

Coop agreed to revise the language and stated that he welcomed additional supporting information.

The Working Group concluded its discussion of Chapter 8.

Next Steps and Announcements

Leigh Ann reviewed upcoming meeting dates, ensured that Working Group members had no other comments at this point for Chapters 3 through 7, then turned the meeting over to Jim for some announcements.

On behalf of Kaye Hayes and himself, Jim Berger explained that a Federal Register Notice (FRN) will be posted to solicit applications for public member positions (four current members’ term will expire in December and the other three members’ term will expire a couple months after). He added that applicants will have 30 days from the notice publication to submit their CV or resume through the link provided in the FRN.

Jim then turned the meeting over to CDC representative Ben Beard for an additional announcement.

Ben explained that CDC has posted its National Public Health Framework for Prevention and Control of Vector-borne Diseases in Humans, an effort involving the following U.S. Federal agencies: Department of Health and Human Services, Department of Agriculture, Department of Defense, Department of the Interior, Department of Homeland Security, and the Environmental Protection Agency. He added that the framework identifies goals and strategies for interagency collaborations related to all vector-borne disease, surveillance, detection, and prevention. He also provided the url: www.cdc.gov/ncezid/dvbd/framework.

Ben thanked Pat and others for providing input on the framework. He stated that it did not go out for peer review; however, CDC did receive feedback, and the framework is consistent with the Working Group’s recommendations.

He identified the next step as the development of a national strategy in collaboration with Jim Berger’s team within the Office of the Assistant Secretary for Health. He noted that the framework and strategy have been developed in response to the Kay Hagan Tick Act.

After ensuring there were no questions, Leigh Ann thanked members for their hard work.

Adjournment

The meeting was adjourned at 1:37 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, Days 1 and 2)

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, Days 1 and 2)

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, Days 1 and 2)

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, Days 1 and 2)

Scott Palmer Commins, BS, MD, PhD, Associate Professor of Medicine & Pediatrics
University of North Carolina; Member, UNC Food Allergy Initiative, Thurston Research Center (Present Day 1, Absent Day 2)

Angel M. Davey, PhD, Program Manager, Tick-Borne Disease Research Program, Congressionally Directed Medical Research Programs, U.S. Department of Defense (Present, Days 1 and 2)

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, Days 1 and 2) - 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, Days 1 and 2)

Sam T. Donta, MD, Professor of Medicine (retired); Consultant, Infectious Diseases (Present, Days 1 and 2)

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, Days 1 and 2)

Kevin R. Macaluso, PhD, MS, Locke Distinguished Chair, Chair of Microbiology and Immunology, College of Medicine, University of South Alabama (Present, Days 1 and 2)

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, Day 1 and first part of Day 2)

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, Days 1 and 2)

Patricia (Pat) V. Smith, President, Lyme Disease Association, Inc. (Present, Days 1 and 2)

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, Days 1 and 2) – Shahla Jilani, Deputy Chief Medical Officer, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services (Alternate absent)

Appendix 2: HHS Support Staff

In alphabetical order:

James (Jim) Berger, MS, MT (ASCP), SBB, Designated Federal Officer, Tick-Borne Disease Working Group, Senior Blood and Tissue Policy Advisor, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services

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

Debbie Seem, RN, MPH, Public Health Advisor, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services

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: Public Comments Subcommittee Members

In alphabetical order:

Scott Palmer Commins, MD, PhD, Physician and Scientist, University of North Carolina Health Care

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

Leigh Ann Soltysiak, MS, Owner, Silverleaf Consulting, LLC

Appendix 4: Writing Groups for the 2020 Report to Congress

Executive Summary—Leigh Ann Soltysiak and David Hughes Walker

Introduction to Tick-Borne Diseases: Where We Are Now—Leigh Ann Soltysiak and David Hughes Walker

Chapter 1: Background—Leigh Ann Soltysiak and David Hughes Walker

Chapter 2: Methods—Leigh Ann Soltysiak and David Hughes Walker

Chapter 3: Tick Biology, Ecology, and Control—Adalberto (Beto) Pérez 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