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                              October 27, 2020, TBDWG Meeting (online)
                              TBDWG October 27, 2020 - Meeting Summary


    

    

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TBDWG October 27, 2020 - Meeting Summary








  
  
    

  
      





*Note: For context and clarity, speaker credentials will be included upon first mention in each meeting’s summary. Subsequently, individuals will be referenced by their first names to equalize expertise across the many diverse disciplines represented in this document. All perspectives and expertise, including patient-lived experience, is valued equally. Speaking on a first-name basis helps the Tick-Borne Disease Working Group ensure that all voices are heard and valued based on merit and without the bias of titles, eminence, or prestige.*
Welcome and Roll Call
James (Jim) Berger, MS, MT (ASCP), SBB, Designated Federal Officer (DFO) for the Tick-Borne Disease Working Group, Senior Blood and Tissue Policy Advisor, Office of Infectious Disease and HIV/AIDS Policy (OIDP), Office of the Assistant Secretary for Health (OASH), U.S. Department of Health and Human Services (HHS), 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).
During roll call, 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, stated that he would need to leave the meeting for an hour and a half, during which time his proxy would be 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.
The meeting started with a quorum.
Co-Chair Welcome and Recap of Meeting 15
Working Group Co-Chair David Walker welcomed all meeting attendees and commented that today the Working Group would make decisions towards completing the 2020 Report to Congress.
Leigh Ann Soltysiak, MS, Founder, Principal, Silverleaf Consulting, LLC; Adjunct Professor, Stevens Institute of Technology, Entrepreneurship Thinking; Tick-Borne Disease Working Group Co-Chair, welcomed everyone. She stated that as a recovered patient, she is proud of the Working Group’s effort and she is excited about what the Working Group will accomplish.
David explained that the Working Group discussed Chapters 3 through 7 at the last Working Group meeting (Meeting 15), and today the Working Group would review the revisions made since last meeting.
Leigh Ann added that the Working Group accomplished a lot at the last meeting. She stated that the Working Group also reviewed and discussed Chapters 1, 2, 8, and 9 at the last meeting.
Meeting 16 Agenda, Goals, and Timeline
Leigh Ann outlined the meeting agenda, stating that the Working Group would review the chapters based on what was discussed in the previous meeting. She clarified that the Working Group would review and discuss the chapters in an order that is based on the stage of review and revision. She stated that in the morning, the Working Group would review Chapters 8, 11, 1, 2, 9, 10, and the report template, including the table of contents and title page, then discuss Chapters 3, 4, 5, 6, and 7 in the afternoon.
David explained that the purpose of the 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. She pointed out that Meetings 17 and 18 would take place on November 17 and December 2, respectively, during which the Working Group would vote through the chapters and the final report. The final deliverable, she noted, 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, Vision Statement, Values
Jim reviewed the Working Group’s Mission Statement, as follows:
The Tick-Borne Disease Working Group’s mission, as mandated through the *21st Century Cures Act*, is to provide expertise and to review all efforts within 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.
Jim announced that his office had put out a Federal Register Notice to seek 2022 Working Group members; and that in honoring the public input requesting more time to be allowed to submit applications, his office would publish another notice to extend the deadline from November 5 to December 5, 2020. He stated that the mission statement would serve as a guide while selecting individual public members.
Working Group Objectives and Duties
Leigh Ann then outlined the Working Group’s charge, as follows:
No later than two years after the date of enactment of the authorizing legislation, develop or update a summary of
		Ongoing tick-borne disease research, including research related to causes, prevention, treatment, surveillance, diagnosis, diagnostics, duration of illness, and intervention for individuals with tick-borne diseases;
			Advances made pursuant to such research;
			Federal activities related to tick-borne diseases, including
				Epidemiological activities related to tick-borne diseases; and
					Basic, clinical, and translational tick-borne disease research related to the pathogenesis, prevention, diagnosis, and treatment of tick-borne disease.
			Gaps in tick-borne disease research described in 3b;
			The Working Group’s meeting; and
			The comments received by the Working Group.
	Make recommendations to the Secretary regarding any appropriate changes or improvements to such activities and research; and
	Solicit input from States, localities, and non-governmental entities, including organizations representing patients, health care providers, researchers, and industry regarding scientific advances, research questions, surveillance activities, and emergingCenters for Disease Control and Prevention Update
Charles Benjamin (Ben) Beard, PhD, Deputy Director, Division of Vector-Borne Diseases, Centers for Disease Control and Prevention (CDC), HHS; Associate Editor, Emerging Infectious Diseases, explained next steps for the National Public Health Framework for Prevention and Control of Vector-Borne Diseases in Humans, an interdepartmental effort led by CDC and developed by five Federal departments (HHS, U.S. Department of Agriculture, Department of Defense, Department of Interior, Department of Homeland Security) and the Environment Protection Agency. Ben stated that the framework has been cleared by HHS, and he reviewed the vision, mission, strategic objectives, and key partners of the Framework, as follows.
**Vision:** A nation where vector-borne diseases no longer threaten human health and well-being.
**Mission:** Protect people from illness, suffering, and death due to vector-borne diseases.
**Strategic Goals:**
Better understand when, where, and how people are exposed to and get sick or die from vector-borne diseases
	Develop, evaluate, and improve tools and guidance for the diagnosis and detection of vector-borne diseases
	Develop, evaluate, and improve tools and guidance for the prevention and control of vector-borne diseases
	Develop and assess drugs and treatment strategies for vector-borne diseases
	Disseminate and support the implementation of effective public health and vector control products, tools, and programs to prevent, detect, diagnose, and respond to vector-borne disease threats**KEY PARTNERS:** Federal government, state and local health departments, vector control agencies, healthcare providers, academic and industry partners, policy- and decision-makers, public health partners, and the public and patients.
Ben further explained that the *Kay Hagan Tick Act*, passed in 2019, authorizes $80 million for vector-borne disease control activities (specifically to support a CDC vector-borne disease Center of Excellence program) and $20 million to state health departments and other territories and municipalities to increase capacity to prevent and respond to vector-borne diseases. He clarified that the money is authorized but not yet appropriated. Ben summarized that the bill also tasks HHS with developing a national strategy, and the framework is a starting point for the strategy.
Public Comments
Leigh Ann introduced the public comment session. She briefly explained the process for giving verbal comments at the meeting and the time allocated for each commenter (three minutes). She 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 (tickbornedisease@hhs.gov).
Seven members of the public provided comments over the phone.
*Janice Sutton:*Janice stated that as a critical care nurse, she saved lives using current science. She expressed dismay that the same medical community, however, neglected her teenage daughter as she suffered from vector-borne diseases. Janice described their “medical nightmares,” including many misdiagnoses. She shared that her daughter was finally diagnosed at 21 with *Bartonella henselae*, *B. quintana*, dysautonomia, autoimmune dysfunction, encephalopathy, and optic nerve ischemia; and she stated that her daughter is now able to attend college part time. Janice questioned why denial of persistent Lyme disease exits, and she suggested moving forward by providing doctors with better tools such as better physician education, utilizing tick-borne disease differential diagnostic algorithms, improving lab testing, protecting doctors who treat chronically ill patients, reforming insurance coverage, and increasing funding for research.
*Dorothy Leland:*Dorothy stated that she is the Vice President of LymeDisease.org and mother of a daughter with long-term Lyme disease. She criticized the membership of the 2020 Tick-Borne Disease Working Group and requested better representation of Lyme disease patients on the next Working Group, including people with persistent Lyme disease and other tick-borne diseases. She stated that those who represent patients should be nominated or endorsed by patient advocacy groups. Dorothy also suggested improving transparency about how Working Group members are chosen and whose financial and professional interests they represent. She criticized that the current Working Group has shifted the focus away from Lyme disease, and she urged HHS to consider these concerns when choosing members for the next Working Group.
*Laura Hovind:*Laura Hovind, CEO of TruthCures, Inc. played an audio recording of Working Group member Gene Shapiro presenting at a conference.
*Phyllis Mervine:*Phyllis stated that she is the president and founder of LymeDisease.org. Phyllis commented that the CDC incidence map does not work for California, adding that the map downplays the risk of Lyme disease in certain counties of California. She pointed out that Mendocino and Trinity counties both have high incidence; however, they are not shown on the CDC Lyme disease incidence map because California is considered a “low-risk” state. She stated that the CDC incidence map affects diagnosis, and she asked CDC to revert back to presenting incidence by county rather than by state.
*Kathy Nodolf:*Kathy stated that she is a board member of TruthCures, a newly founded 501(c) organization whose mission is to enable Lyme disease patients to obtain a valid diagnosis and care. She called for a correct definition of “chronic Lyme disease,” noting that it would improve the health of those affected by the disease. Kathy expressed her displeasure toward one of the Working Group members, and she encouraged everyone to read her colleague Laura Hovind’s written public comment.
*Carl Tuttle:*Carl Tuttle, Member of New Hampshire Governor Chris Sununu’s HB490 Commission to Study Lyme Disease, read a letter/inquiry sent to one of the Working Group members. Carl stated that CDC’s refusal to acknowledge persistent infection has left hundreds of thousands of patients in a debilitated state because of misdiagnosis and failure to recognize the pathogen as an antibiotic resistant/tolerant superbug. He requested a response to his inquiry.
*Christopher Reilly:*Christopher stated that he is a Lyme disease patient from New Jersey. He said that he was excited when the Working Group was established, but soon realized that multiple interests exist within the Working Group. Christopher criticized the Working Group’s approach to transmission mechanisms of tick-borne diseases, vaccines, and persistence of the *B. burgdorferi* after antibiotic treatment. He expressed his frustration about misdiagnosis and missed diagnosis of Lyme disease, as well as the lack of effective treatment. He called to disband the American Lyme Disease Foundation, and he criticized conflicts of interest of previous Working Group members.
Public Comments Subcommittee Update
Leigh Ann read the disclaimer, explained how public comments are received and processed, and provided a summary of key themes and priority areas raised by members of the public in August. She emphasized that key themes of each month’s public comments have been presented at every Working Group public meeting, and that detailed comments can be found on the Tick-Borne Disease Working Group website. Leigh Ann reviewed comment key themes from August.
Scott Palmer Commins, BS, MD, PhD, Associate Professor of Medicine & Pediatrics University of North Carolina; Member, UNC Food Allergy Initiative, Thurston Research Center then reviewed the key themes of the comments received in September.
Review of Chapter 8: Epidemiology and Surveillance Review
Led by Ben and Gene, the Working Group reviewed member comments one by one and explained revisions made in response. Ben explained that the co-leads reviewed and addressed most of comments.
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. asked why testing and diagnosis of Lyme disease is not discussed in the “Major Challenges and Issues” section of Chapter 8.
Ben pointed out that this chapter is about epidemiology and surveillance, and he questioned if detailed discussion of diagnosis and testing belong in this chapter.
Pat responded that other diseases were discussed in Chapter 8, and therefore, Lyme disease should be discussed there as well.
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 adding a succinct sentence and providing a link to the chapter on diagnosis (Chapter 4).
Ben stated that he would be okay with adding a statement.
**Comment 2 from David Walker**
	In his comment, David pointed out that there are definitive laboratory diagnostic tests for Lyme disease. He explained that Lyme disease progresses more slowly than some of the other tick-borne diseases, and there is a better opportunity to make a diagnosis.
Pat responded that studies show that currently available laboratory tests are not always able to detect Lyme disease, and she insisted that this chapter should address the need.
David noted that pathogenesis of Post-Treatment Lyme Disease Syndrome (PTLDS) is unsettled.
Ben noted that he would add a statement regarding direct tests for the early stage of Lyme disease.
Gene added that the co-leads could clarify the sentence by adding “there is a need for better diagnostic tests for Lyme disease.”
Ben and Gene agreed to work together to address the two comments.
**Comment 3 from David Walker**
	David commented that “asymptomatic” and “subclinical” are redundant and suggested choosing one or another.
Ben agreed to the suggestion.
**Comment 4 from Pat Smith**
	In her comment, Pat suggested clarifying that the study of *Ehrlichia chaffeensis* infection was conducted in Missouri, adding that the findings may not be applicable to other states.
David and Gene responded that it is applicable to all states where Lone star ticks exist. Gene agreed to clarify that the study was conducted in Missouri.
**Comment 5** **from David Walker**
	David pointed out a typo.
Ben accepted the suggested change.
**Comments 6 and 7 from Scott Cooper and Pat Smith (respectively)**
	Both Pat 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, U.S. Department of health and Human, questioned the validity of the Bayesian theory, disagreed with the statement about the value of laboratory testing in determining Lyme disease incidence, and suggested revisions. In his comment, Coop pointed out that three studies conducted by CDC showed a ten-fold under-estimation of Lyme disease (from 30,000 reported cases to 300,000 estimated cases).
Gene explained that the numbers were based on a theoretical study, not real data, and the assumption is that there is under-reporting in areas where Lyme disease is endemic. He commented that the statement as written is true.
Ben explained the estimates of two of the studies Coop had mentioned, noting that the 300,000 estimated cases correlate with the counties that have high incidence of Lyme disease. He clarified that the 300,000 cases are not distributed evenly throughout the United States; rather, it is an estimate of under-reporting in high-incidence areas.
Sam Donta, Professor of Medicine (retired); Consultant, Infectious Diseases, pointed out that travel-related incidences need to be reflected in the paragraph.
Gene replied that behavioral factors, such as travel history, are considered in pre-test probability.
In response to Sam, Ben noted that studies have established that Lyme disease is reported as a travel-related infection. He explained the shortcomings of surveillance when it comes to capturing case numbers in low-incidence states that have possible travel-associated infections. He stated that he would be willing to include content about pre-test likelihood and its limitations, but because evidence is lacking, he would be reluctant to say that there is equal risk for Lyme disease in all areas of the country.
Sam generally agreed with Ben and added that the shifting incidence of disease needs to be accounted for in the paragraph. He highlighted the need for increased awareness of disease risk in low-incidence states.
**Motion and discussion**
	David made a motion to restore the paragraph back to the original language.
Coop pointed out that Ben had suggested making revisions to clarify the content.
Gene expressed that he was unclear about what needs to be clarified.
Ben noted that Chapter 8 belongs to the whole Working Group, and he would be willing to move forward based on the Working Group’s decision.
Gene seconded David’s motion.
Pat commented that the surveillance in low-incidence areas is inadequate, and she asked how CDC is able to deem certain cases “travel-related.” She expressed concern that applying a mathematical formula to an issue that is constantly evolving (specifically, the geographic spread Lyme disease) would prevent patients in states deemed “low incidence” from getting diagnosed and treated. She stated that greater investment is needed to conduct surveillance in those states and regions.
David described his involvement in tick surveillance studies conducted in Arkansas, Oklahoma, and Texas and explained that *B. burgdorferi* was not found.
Sam expressed his approval of including the revisions Ben had suggested earlier in the discussion.
Ben explained that CDC does have data on travel-related cases. As a compromise, he suggested adding a statement to clarify limitations related to distribution of Lyme disease.
Sam stated that he would need to see the revisions before casting his vote, and he disagreed with David’s suggested addition to the paragraph regarding false positives.
Gene reiterated that the main point of the paragraph is to highlight the limitations of pure laboratory test results, which cannot be equated to clinically diagnosed cases.
Referencing the One Health concept, Beto suggested broadening the discussion to include all tick-borne diseases and vectors to capture the larger scope of the problem throughout the United States.
Ben explained the meaning of the paragraph within the context of the chapter. He read the recommendation it pertains to, noting that the intent of the paragraph is to describe the challenges and limitations of direct lab testing for surveillance, not clinical diagnosis (under-reporting).
Coop asked if the following addition by David is included in the motion: “Particularly in the many states were *B. burgdorferi* is rare or nonexistent in ticks. More importantly, in order to determine the ground truth regarding prevalence and incidence of Lyme disease, researchers must be able to look at all of the available data, that is, not only laboratory test results and case reports, but also insurance claims and all other relevant and related data sources that is available.”
David replied that the motion does not include that language.
Pat asked David to read his motion.
David reiterated his motion to restore the paragraph to the original language as follows: “While direct reporting by laboratories will increase the number of reported cases, it is important to realize that the positive predictive value of laboratory test results for Lyme disease is highly dependent on the prior probability that the patient has Lyme disease (Seltzer & Shapiro, 1996; Tugwell et. al., 1997). Prior probability depends on both the clinical and the epidemiologic history.  For example, many positive laboratory test results from areas in which endemic transmission of Lyme disease has never been documented will be false-positive results.”
Working Group members continued to discuss the intended meaning and implications of the content.
Pat expressed concern about the last two sentences, stressing that the statements will prevent patients from being diagnosed and treated in states considered low incidence.
David explained that the statement pertains only to the interpretation of tests for surveillance purposes.
Pat responded that for Lyme disease, surveillance definitions are used to diagnose patients, emphasizing that this has prevented patients from being diagnosed and treated.
Gene explained that intended meaning of the content is to outline the limitations of direct reporting as it relates to false positive results.
Sam expressed his concern about the definitive nature of the statements in question, noting that it will discourage clinicians from diagnosing patients who have a positive test result with Lyme disease.
David disagreed.
Pat replied that, for decades, patients with positive test results for Lyme disease in states considered low incidence have not been given treatment.
David commented that the statement relates exclusively to the interpretation of laboratory test results and understanding when false positives can occur.
	Pat responded that clinicians will not necessarily interpret the statement as it is intended.
Leigh Ann commented that there is room for interpretation in terms of Lyme Disease. She suggested that the Working Group vote on David’s motion, then decide how to proceed.
**Vote**
	Seven members voted no to restore the paragraph to the original language. Six members voted yes, and one member was absent. The motion failed.
Leigh Ann then asked Ben and Gene to go back and discuss the next step for the paragraph in question.
Ben commented that the Working Group is conflating surveillance and reporting with clinical diagnostics. He emphasized that the content needs to support the recommendation. He noted that he understood Pat’s concerns. He suggested 1) restoring the paragraph so that it is close to the original language, 2) adding qualifying statements about gaps in knowledge related to current distribution, 3) and clarifying that laboratory tests do not replace clinical diagnostics.
Sam expressed his support for Ben’s suggestion and recommended that the Working Group review the revised paragraph at the next meeting.
Ben and Gene agreed to revise the paragraph.**Comment 8 from David Walker**
	David suggested adding the following phrase to the paragraph discussed in the previous section: “particularly in the many states where *B. burgdorferi* is rare or nonexistent in ticks.”
Because David’s suggested text related to the paragraph the Working Group had just discussed at length, Ben suggested that he and Gene work on revising the whole paragraph.Referencing a comment from Coop, Gene questioned the relevance of insurance claims to lab test results and tick surveillance.
Ben replied that while insurance claims can be useful in the context of burden, distribution, and under-reporting, the chapter is about surveillance rather than burden of illness, and he did not see how referencing insurance claims would support the recommendation.
David asked Ben if he agrees with his suggested addition.
Ben responded that he didn’t know how David’s statement relates to the issue at hand. Regarding insurance claims, he suggested a general statement about limitations in knowledge about distribution and pre-test likelihood.
Gene reiterated that the point of the paragraph is to emphasize the need to distinguish between cases reported based solely on laboratory testing and those based on clinical data and supportive laboratory test results. He explained that the recommendation relates to how the information is tabulated.
Ben reminded the group that the recommendation is about direct reporting of laboratory testing, not patient care, and this paragraph discusses the pros and cons of direct reporting of laboratory tests.
Pat responded that this recommendation will affect patient care. She also disagreed with David’s addition about states where *B. burgdorferi* is “rare or nonexistent.”
Sam suggested letting Ben revise the paragraph.
**Motion, discussion, and vote**
	Ben made a motion to restore the paragraph back to the original language (that is, remove all the comments and revisions made by other Working Group members); and then he will add clarifying language to address the limitations of direct reporting of laboratory test results, including changing geographic distribution of Lyme disease and its effect on pre-test likelihood.
Kevin R. Macaluso, PhD, MS, Locke Distinguished Chair, Chair of Microbiology and Immunology, College of Medicine, University of South Alabama seconded the motion.
Eleven members voted yes, two members voted no, and one member was absent. The motion passed.
**Comment 9 from Pat Smith**
	Pat questioned the citations related to Rocky Mountain spotted fever (RMSF). She stated that the Ormsbee review was published in the 1970s, and the Parker study, published in 1941, is not accessible. She added that up-to-date references should be used to highlight what is happening today.
David replied that the issue is what happens when patients are not given appropriate treatment. He added that antibiotics were not available in the era of those publications.
Pat emphasized that the data are outdated and do not reflect the current status of RMSF.
David pointed out the limitations of current studies, noting that current data do not reliably reflect fatality rates without treatment.
Pat stated that the studies used should be accessible to the reader. She agreed that RMSF is a serious disease; however, she added that she was unable to find a study that supports a fatality rate of greater than 20 percent.
David replied that the Parker study supports that statistic because it was conducted prior to the use of antibiotics. He stated that the study demonstrates the severity of RMSF if it is not diagnosed and promptly treated.
Coop questioned why the paragraph highlights the history of fatality rates and stressed that the current status of the disease should be the focus.
Dennis commented that the Parker reference conveys the significance of delaying treatment, noting that the longer treatment is delayed, the closer one comes to the pre-antibiotic era.
Coop once again questioned the relevance of the studies and asked why more current data is not being included.
Beto suggested a study published in 2020 that discusses incidence of RMSF. However, David explained that it is not relevant to the issue at hand.
Ben proposed including a 1995 article about the association of therapeutic delay with high case fatality rates of RMSF. He explained the article’s relevance to the chapter content.
Sam agreed that the article makes the point that RMSF remains a serious disease and suggested quoting directly from the article.
Pat requested that the date (or date range) be included for any case fatality rates provided in the chapter.
Ben commented that he would revise the text to reflect the will of the Working Group.
David stated that since the early studies were conducted, neither people nor the organisms have changed.
	Pat referenced a study about a new and virulent strain of *Rickettisia* in Brazil. She also highlighted other aspects of modern medicine that might now be able to save patients who have not been treated promptly for RMSF.
David commented on the fatality rates in Brazil and Mexico.
Coop suggested distinguishing between the pre- and post-antibiotic era references.
Ben agreed to making the distinction. He further explained why the fatality rates from the pre-antibiotic era are relevant to therapeutic delay and mortality associated with RMSF today. He offered to make changes that will satisfy everyone’s concerns, specifically by 1) highlighting the importance of early diagnosis and treatment, 2) distinguishing between the pre- and post-antibiotic era, and 3) including more recent references.
Pat agreed that Ben’s suggested article should replace those currently provided in the chapter.
Others agreed with Ben’s suggested changes, including Coop. Ben stated that the Working Group would be able to review his revisions at the next meeting.
**Comment 10 from Pat Smith**
	In response to Pat’s question about a “streamlined reporting system,” Ben explained that “streamline” may not be the best word choice. He described the current challenges associated with reporting.
Pat suggested that the desired system might be one used by every state in the same way all the time across the country.
Ben agreed and suggested changing “steamlined” to “standardized.”
Pat commented that advocates would be in favor of such a system.
**Comment 11 from Pat Smith**
	Pat explained that the process for including minority responses in the report appears to have changed during the two weeks prior to the meeting, causing her to feel uncertain about whether or not her minority response in Chapter 8 would, in fact, remain in the report.
**Motion and Discussion**
	Pat then made the following motion: “I move that Pat Smith’s minority response shall remain in Chapter 8 where it was placed after she followed the Working Group procedures then in place, she having voted no to the recommendation the minority report addresses at a public Working Group meeting and having submitted the minority response for chapter placement on April 17, 2020. The minority response was placed where it has remained in Chapter 8 for all Working Group members to see after placement and discussion of many iterations of the chapter. There is no requirement for her to vote against the chapter for it to remain there as she has voted no to the recommendation.”
Coop seconded the motion.
Ben asked Pat for clarification.
Pat further explained why she made the motion, noting that it was her understanding when she originally submitted the minority response (in the spring of 2020) that if a member voted against a recommendation, he or she could prepare and submit a minority response. She added that in recent weeks, she had received three messages outlining different procedures for including minority responses. She noted that one message stated that any Working Group member can submit a minority response at any time and another stated that members had to vote against an entire chapter in order to submit a minority response.
Dennis expressed confusion, noting that chapters have not yet been voted on.
Pat explained that her understanding of the process last April was that, because she had voted against a recommendation, she was entitled to write a minority response. She expressed her confusion about receiving a message two weeks ago stating that she needed to vote against an entire chapter in order to submit a minority response.
Leigh Ann responded that, to date, the Working Group has not discussed the process for submitting a minority response, and therefore, there is nothing to discourage their inclusion. She encouraged the group to follow precedent and gave an example from the Tick-Borne Disease Working Group 2018 Report to Congress in which a minority response was included without the writer having voted against any of the report content.
Pat disagreed that minority responses should be allowed if the writer has not voted against at least some part of the report. She stressed that Working Group members should be contributing to the consensus process and working toward a common goal. She cautioned that allowing anyone to submit a minority response regardless of their participation in the process or how they voted will result in many alternate responses. She also explained that the 2018 process was constrained by time.
Leigh Ann responded that while technically, minority responses can be submitted by anyone, the Working Group’s values guide the group and encourage collaboration and compromise.
Pat clarified that by allowing anyone to write a minority response without voting on content diminishes accountability.
Ben agreed that a vote needs to take place in order to determine whether or not there is a minority. Once that is determined, he added, minority responses can be written. He stated that members should vote on the recommendations and on the chapters. He expressed his support of keeping Pat’s minority response in Chapter 8.
DFO Jim Berger commented that Ben’s statement is correct. He clarified that the approach to handling minority responses was created and adopted by Working Group members when they wrote their 2018 report. He added that there is no written policy regarding minority responses and that the Working Group should discuss and decide how to handle the inclusion of minority responses in the report.
Ben commented that if a member votes against something in the report, they should have an opportunity to include a minority response. He asked Pat if this reflects her understanding.
Pat agreed with Ben’s assessment but stated that it remains important to her that her motion be passed by the group.
Sam commented that some kind of regulation is needed to dictate how minority responses are handled.
Leigh Ann expressed concern about deviating from the precedent set in the 2018 Report to Congress. She pointed out that since the 2020 recommendations were approved in the spring, the report has evolved, and members may feel strongly about certain sections of the report, for example, rationale that supports the recommendations.
	Coop and Ben commented that without votes, a minority cannot be determined.
Beto asked why following precedent is considered problematic.
Coop and Pat responded that the 2018 process was rushed.
Pat again expressed concern about the mixed communications she had received two weeks ago.
Pat stated that she would retract her motion if the following motion were placed on the floor: “Anyone can write a minority response if he or she votes against the report or a portion of the report.”
Ben commented that he would support such a motion, adding that he feels it is consistent with spirit of the previous report. He agreed that the 2018 process was rushed, but that it was clear when members had a strong conviction against a statement, recommendation, or section of the report.
Leigh Ann stated that she did not think a vote was required because the Working Group’s values highlight the importance of including minority viewpoints.
Pat stressed the need for a definitive decision.
Coop agreed that a more organized process for including minority responses is needed.
Pat commented that she would withdraw her motion and asked if Coop would withdraw his.
Coop responded that there are two different issues being discussed: 1) keeping Pat’s minority response in Chapter 8, and 2) determining how to handle the minority response process going forward.
Pat stated that her motion is, therefore, still on the floor. She added that she felt she had followed the rules when she submitted her minority response and asked for confirmation that she did, indeed, follow them.
Leigh Ann commented that there were no rules in place at the time Pat submitted her minority response.
Pat asked for a vote on her motion.
Leigh Ann asked for clarification about the overall process of including minority responses, asking if the rules were dictated by the precedent or whether or not the group needs to establish rules.
Coop recommended that the group vote on Pat’s motion before discussing the broader process.
Leigh Ann expressed her discomfort about voting on a motion that argues the rules were followed when there were no rules in place.
Pat reiterated that she had followed the rules as she understood them. She highlighted again the mixed messages she had received in recent weeks about the overall process.
Leigh Ann asked Pat if she was concerned that her minority response would not be included in the report.
Pat responded that yes, she was concerned.
Leigh Ann explained that her understanding was that any minority response could be included in the report.
DFO Jim Berger provided the responses he had received in recent weeks from the Office of General Counsel on the inclusion of minority responses. He read them to the group as follows:
Response 1: “Minority Reponses are included in the report when members of the TBDWG either disagree with the recommendations or agree with the recommendations but disagree with the verbiage that the co-chairs add to the chapters to provide their support, interpretations or extraneous and questionable information that is included in the chapters. If there was total agreement to the verbiage that was added to the chapter supporting the recommendations, then there would be no need for a ‘Minority Response.’”
Response 2: The inclusion of minority responses in the report was an approach created and adopted by the Working Group members while drafting the first report. There is no written policy about the inclusion of minority responses in the report. As it is a decision of the Working Group, the Working Group membership should follow its process to discuss and decide generally whether to allow minority responses in the second report.”
Pat reiterated that she had submitted her minority response and she would like to protect it with a vote by the Working Group.
	Working Group members continued to discuss whether or not a vote on the Chapter 8 minority response is needed given the General Counsel’s statements.
Kaye Hayes, MPA, Alternate Designated Federal Officer, Tick-Borne Disease Working Group, Executive Director, Presidential Advisory Council on HIV/AIDS, Principal Deputy Director, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services, reminded the group that there is a motion on the floor.
Members continued to seek clarification on both the process and the motion on the table.
**Vote**
	Pat reread her motion to keep her minority response in Chapter 8. Twelve members voted yes. Two members were absent. The motion passed.
**Discussion of the Process for Including Minority Responses**
	The Working Group then discussed whether or not members should be allowed to include minority responses without having voted against report content.
Beto commented that, based on the statements by the Office of General Counsel, all members have the right and ability to issue a minority response in the final report.
Pat responded that the Working Group can determine the policy based on those statements, adding that members should have to register their disagreement with a vote against report content.
Leigh Ann reminded the group of the precedent set during the 2018 process.
**Motion and Discussion**
	Pat made the following motion: In order to submit a minority response, members must vote against either a report chapter or some portion of that chapter.
David seconded the motion.
Beto asked if this ruling would have any impact on the subcommittee reports, which also include minority responses.
David, Pat, and Jim clarified that this decision would not impact the subcommittee process unless the Working Group decided to change the subcommittee’s rules. Jim noted that the subcommittees are not subject to the same rules as the Working Group.
Leigh Ann asked for clarification on the motion, noting that when someone votes against content, this should include verbiage within the rationale provided for recommendations.
Pat replied that “some portion of that chapter” includes verbiage within rationale, as well as tables and graphics.
Coop suggested rephrasing the motion to say that members must vote “in the minority” rather than saying they voted for or against something.
Pat and Leigh Ann Agreed.
**Vote**
	The Working Group voted on the following motion: In order to submit a minority response, members must vote in the minority on either a report chapter or some portion of that chapter. Thirteen members voted yes. One member was absent. The motion passed.
Review of Chapter 11: Looking Forward Chapter
After a short lunch break, DFO Jim Burger conducted a roll call, and the Working Group resumed the meeting with a quorum. Dennis stated that he would need to leave the meeting at 2:00 pm and Sam Purdue would step in while Dennis was away.
The following is a summary of the Working Group’s discussion of the Looking Forward chapter.
**Comment 1 from Pat Smith**
	Regarding Pat’s comment about outreach to a broader group of stakeholders, Leigh Ann responded that the intent of the statement is to avoid being overly prescriptive.
Pat responded that she is favorable to having a broader group of stakeholders participating in the Working Group subcommittees but not as members of the Working Group itself.
Leigh Ann replied that the intent is not to expand Working Group membership to include new categories of stakeholders; rather, the next Working Group can interpret the suggestion as members see fit.
Pat expressed concern about adding industry stakeholders to the Working Group.
David commented that the phrasing is acceptable as is and added that engaging additional stakeholders might benefit the Working Group.
Pat stated that the Working Group’s charter stipulates which stakeholder categories can be included. She cautioned against making any changes to the types of members who can join the Working Group.
Leigh Ann reiterated that the intention is not to expand membership but to engage in outreach to a broader group of stakeholders in order to obtain other sources and types of information to address tick-borne diseases.
Pat, Leigh Ann, David, and Sam (Donta) continued to discuss how such stakeholders would be engaged and how prescriptive to be in the chapter.
**Motion and Vote**
	Gene made a motion to accept the language as written.
Beto seconded the motion.
Eleven members voted yes, two members voted no, and one member was absent. The motion was passed.
**Comment 2 from David** **Walker**
	David explained that the paragraph describes chronic issues that are associated with Lyme disease rather than with other tick-borne diseases. He suggested removing “other tick-borne diseases” from the paragraph.
Leigh Ann accepted the suggested change.
The Working Group concluded their discussion of Chapter 11.
Review of Chapter 1: Background
**Comment 1 from Leigh Ann**
	Leigh Ann made an editorial comment on the acronym “TBD.” She asked the group to move on the next comment as her comment had been addressed.
**Comment 2 from Pat Smith**
	Pat suggested removing the word “(possible)” from the table entitled “Tick-Borne Diseases and Conditions Currently Recognized in the United States,” adding that CDC information supports her suggestion.
David agreed to make the change.
**Comment 3 from Pat Smith**
	Pat explained that, according to the CDC website, the vector for Bourbon virus is the lone star tick (*Amblyomma americanum*).
Ben checked his sources and stated that the lone star tick can be listed as the putative vector.
David suggested changing “Undetermined” to “Lone star tick (putative)” in the table.
Pat agreed.
Beto stated that he needed to leave the meeting, adding that Kevin will vote on his behalf.
**Comment 4 from Pat Smith**
	Pat explained that there should be a reference to the link or url for the CDC national tick surveillance program.
Ben replied that he supplied the link for Chapter 3 and could provide it for Chapter 1 as well.
**Comment from 5 Pat Smith**
	Pat explained that in addition to referencing the available science, real-world evidence, as well as diagnosis and treatment of tick-borne diseases, should also be mentioned.
The Working Group worked together to wordsmith Pat’s suggestions and agreed to the revisions.
**Comment from 6 from Leigh Ann Soltysiak**
	Leigh Ann pointed out that “Public Comments” should be changed “Public Input” to accurately reflect the title of Chapter 10.
David agreed with the revision.
The Working Group concluded its discussion of Chapter 1.
Review of Chapter 2: Methods
**Comment 1 from Pat Smith**
	Pat pointed out that each Working Group member volunteered to co-chair “at least one” subcommittee. She suggested replacing “one” with “as least one.”
The suggested change was accepted.
**Comment 2 from Leigh Ann**
	Leigh Ann suggested adding the Federal Inventory Subcommittee and Public Comment Subcommittee to the list of Working Group subcommittees.
Others agreed.
David suggested revising the statement accordingly.
Leigh Ann suggested adding a transition statement.
**Comment 3 from Pat Smith**
	Pat asked for clarification on how the Working Group Co-Chairs and DFO “oversaw” Working Group activities.
David stated that the Co-Chairs had weekly meetings with the DFO and other administrators.
Pat asked for clarification about who was involved.
DFO Jim Berger explained that the “administrators” David mentioned are staff members from the Office of Infectious Disease and HIV/AIDS Policy (OIDP) who provide administrative support to the Working Group such as publishing Federal Register Notices and posting public comments and meeting information on the website.
Leigh Ann commented that the statement in the chapter would be clarified.
**Comments 4 and 5 from Leigh Ann Soltysiak**
	Leigh Ann suggested clarifying that a Federal Inventory Subcommittee was formed to provide oversight of the Federal Inventory process. She also suggested replacing “subcommittee” with “Public Comments Subcommittee” in the last paragraph.
Pat agreed to the change.
The Working Group concluded its discussion of Chapter 2.
Review of Chapter 9: Federal Inventory
At this point, Dennis asked if the Working Group would need to vote on the chapters as they move along.
Ben expressed his view that the Working Group can vote as they move along.
The group then discussed if they should go back and vote on the chapters that have been discussed.
Considering that the Working Group would need to review one of the previous chapters again at the next meeting, Sam suggested voting on those chapters at that time.
Kevin commented that the Working Group is in a position to wrap up Chapters 1 and 2.
Pat suggested moving forward first and coming back to vote on Chapters 1 and 2 if there is time.
Leigh Ann agreed with moving forward.
**Comment 1 from Pat Smith**
	In her comment, Pat suggested replacing “including” with “includes.”
The suggested change was accepted.
**Comment 2 from David Walker**
	In his comment, David clarified that “provider” is the intended word.
The suggested change was accepted.
**Motion and Vote on Chapter 9**
	Sam motioned to approve Chapter 9: Federal Inventory.
Pat seconded the motion.
Thirteen members present at the meeting unanimously voted yes to approve the chapter. One member was absent. The motion passed.
**Motion and Vote on Chapters 1 and 2**
Kevin motioned to vote on and approve the Chapter 1: Background and Chapter 2: Methods.
Dennis seconded the motion.
Thirteen members present at the meeting unanimously voted yes to approve Chapters 1 and 2. One member was absent. The motion passed.
Review of Chapter 10: Public Input
**Comment 1 from Leigh Ann**
	Leigh Ann suggested using a patient picture to demonstrate that Chapter 10 reflects the patient’s and the public’s perspectives.
Angel agreed with Leigh Ann’s suggestion.
**Comment 2 from Angel Davey**
	In her comment, Angel informed the Working Group that a public comment received in September 2020 suggested discussing multiple chemical sensitivity in the Looking Forward chapter (rather than in the Public Input chapter).
Sam commented that what is described in Chapter 10 is fine as is.
**Comment 3 from Sam Donta**
	In his Comment, Sam asked why the references provided by one of the public commenters were cited.
The group discussed whether or not to include references provided by individual public commenters in their comments. A few members pointed out that the Public Input chapter summarizes the key themes of all the comments received; therefore, including some commenters’ references but not others would not be fair nor appropriate.
Angel agreed. She stated that the co-leads would remove the references from the paragraph.
**Comment 4 from Angel Davey**
	Angel said that the topic (IDSA and ILADS guidelines) might have been covered in the Federal Inventory-related recommendations.
Ben clarified that CDC does not have any guidelines on its website.
Angel noted that it would be fine to leave the sentence as is.
**Comment 5 from Angel Davey**
	Angel asked if the new ICD-11 codes have already been updated.
Ben explained that ICD-11 is still in progress, and he acknowledged that he was not familiar with the process.
Angel stated that it would be fine to leave the sentence as is.
**Additional discussion on graphics**
	Leigh Ann resumed the discussion on graphics (Comment 1). She asked if anyone would be opposed to including a patient picture or patient-related graphic in the chapter.
Jennifer responded that her team could help come up with an appropriate image.
Leigh Ann asked if other Working Group members support using such a graphic.
Sam stated that he liked the idea.
Pat suggested waiting to see the graphic and then vote on it.
Angel agreed.
**Motion and Vote**
	Coop made a motion to vote on and accept Chapter 11: Looking Forward.
David seconded the motion.
Ten members voted yes to approve Chapter 11. Two members voted no, and two members were absent at the time. The motion was passed.
Review of the Report Template
Contractor Jennifer Gillissen of Kauffman and Associates presented the revised report template, and welcomed additional comments.
Sam suggested using some photos on the cover that better illustrate the gravity of tick-borne diseases.
Other members agreed. Beto suggested moving the microbe photo from the back cover to the front cover.
Sam commented that the marching photo (“Help us find a cure”) is compelling and suggested using it on the front cover.
After further discussion, the Working Group decided to use the following pictures for the front cover: a tick (on a person), CDC’s Bell’s palsy image, patients marching. Members generally agreed that the main picture (a family playing sports) could.
Review of the Table of Contents
Pat suggested adding an appendix to include the questionnaire used in the Federal Inventory survey. She pointed out that under the *Federal Advisory Committee Act*(FACA), the entire inventory should be posted publicly. She added that inclusion of the questionnaire in the appendix will show the public how the Working Group collected the data. Jim confirmed it is okay to include the questionnaire in the appendix if the Working Group agrees.
Sam Donta commented that the Working Group has not reviewed the Executive Summary, and he suggested adding Chapter numbers.
Jennifer explained that the Executive Summary has not yet been created as the chapters are still in progress.
Pat and Jim discussed if the agencies’ responses to the inventory questions could be released to the public. Pat reiterated that according to FACA rule, they need to be made public. Jim noted that he would seek clearance from the Office of General Counsel.
Pat suggested posting the questionnaire while waiting for clarification on whether or not the responses can be released.
A few Working Group members asked to revise their credentials for accuracy.
Leigh Ann suggested adding a link to refer people to the Tick-Borne Disease Working Group website and highlighting that additional information is available.
Jennifer asked if the Working Group wants two or three photos for the back cover.
David suggested using a photo of the Working Group. However, he was informed that there were none available.
Leigh Ann suggested including a photo that indicates greater diversity.
Jennifer encouraged the Working Group to provide additional suggestions following the meeting.
Review of Chapter 3 through 7 in the Report Template
Jennifer explained that Chapters 3, 4, 5, and 6 have been put in the report template, and additional comments have been added to the template.
Coop commented that the text following the recommendations in some chapters start with the heading “Rationale,” some do not. He suggested establishing consistency across all chapters.
Jennifer replied that her team would review the chapters to ensure consistency.
Beto commented that several chapters do not contain images, and he wondered if it is too late to include some.
Jennifer replied that they could use the tick photo to replace the icon in Chapter 3. She explained that the 2018 Report contains patient stories, and inclusion of additional images in the 2020 Report would need to be decided by the Working Group.
Review of Chapter 3: Tick Biology, Ecology, and Control
The Working Group reviewed the figures included in Chapter 3 and then discussed the comments.
**Figure 1: Increasing Number of Tick-borne Pathogens, 1960-2018**
	The co-leads noted that they would incorporate Ben’s suggested change (that is, remove the askerisk and delete “putative”) add the reference provided by Ben.
**Figure 2: One Health Approach**
	No comments.
**Figure 3: *Ixodes scapularis* Life Cycle**
	No comments.
**Figure 4: Previous Efforts by CDC to Collate National, County-scale Data: 1996 vs. 2020**
	Pat wanted to know where the 2020 map came from.
Ben explained that the data represent a work progress. The map, he added, is based on the most updated information from the ArboNET portal. He noted that, while the map is not currently on CDC’s website, it will eventually be placed there.
Pat suggested adding a note or sentence stating the data in the map represent a work progress and are continually being updated.
Ben stated that he would provide descriptive language.
**Figure 5: Historic and Current Expanded Distribution of Lone Star Ticks (*Amblyomma americanum*)**
	No comments.
**Comment 1 from Pat Smith**
	Pat explained that the placement of “(Figure 5)” is confusing when placed next to the Eisen, 2020 citation.
Beto commented that he and Kevin would double-check the placement.
Kevin suggested moving the citation to a more appropriate location in the text.
**Figure 5 Discussion Continued**
	Ben noted that the fourth bullet point on p. 9 references the ArboNET system.
Pat suggested connecting the verbiage in the bullet point to the map in Figure 5.
**Comment 2 from Pat Smith**
	Pat asked why references are not provided for the bullet points under the sentence “Other barriers and gaps include the following:”
Beto and Kevin stated that they would try to find available references and explained that the bullet points are based on the consensus of the Tick Biology, Ecology, and Control Subcommittee and.
**Comment from Pat Smith**
	Pat commented that cattle tick fever still exists in the U.S. and cattle fever ticks are still present in Southern Texas. She suggested adding language clarifying that cattle fever ticks are still present in small areas of Texas, especially along the U.S.-Mexico border.
Beto replied that the disease was eradicated in the U.S., and that it is true that the disease and ticks still remain in Mexico. He agreed that the disease remains a concern, and he noted that he would revise the sentence to address the concern.
The Working Group completed its discussion of Chapter 3.
Review of Chapter 4: Clinical Manifestations, Diagnosis, and Diagnostics
The Working Group reviewed and discussed the comments in Chapter 4.
**Comment 1 from Angel M. Davey**
	Angel pointed out that there was a public comment suggesting the inclusion of multiple chemical sensitivity in Table 1 (“Clinical Symptoms Associated with Lyme Disease and Lyme-like Illnesses).
Sam responded that the table is inclusive, and no further changes need to be made.
**Comment 2 from David Walker**
	David commented that the paragraph starting with “Furthermore, issues associated with current immunological diagnostic tests...” contains opinions that are not sufficiently evidence-based.
Sam responded that the cited references provide support and that the last sentence of the paragraph states that more definitive testing is needed. He further explained that there are multiple animal data regarding IgM and IgG responses. He explained that his and other clinicians’ observations suggest that the responses are to the biomarkers of *B. burgdorferi*, which he acknowledged needs to be further investigated and a more specific diagnostic test is needed. Sam suggested that if members disagree with the statement in the chapter, they can write a minority response.
Gene commented that he has written a minority response.
Beto asked if the minority response would need to be voted on.
Leigh Ann referenced the decision made earlier by Working Group, adding that in order to include a minority response, members need to vote in the minority on some part of the chapter content.
**Motion, Discussion, and Vote**
	Pat made a motion to leave the language of the paragraph as is.
Coop seconded the motion.
Working group members discussed the voting process and debated whether or not they should vote paragraph by paragraph or vote on portions of the report. Different views were expressed. While some members suggested that the Working Group can vote on portions of the report, others expressed concerns and pointed out that such an approach may lead to rejections of a whole chapter.
Sam asked another process-related question. He wanted to know how to handle comments made after the language had already been discussed.
Pat reminded the group that there was a motion on the floor and insisted that the Working Group should vote.
**Vote**
	Eight members voted yes, two voted no, two abstained, and two were absent at the time. The motion was passed.
**Comment 3 from David Walker**
	David commented that the paragraph starting with “In contrast to patients with Lyme arthritis...” contains contradictory information on late Lyme disease serologic data. He expressed his view that there is insufficient evidence to support the argument.
Sam explained that the information came from a subcommittee report, and it is based on clinical observation and backed by animal observations.
Gene asked what the animals’ symptoms are.
Sam explained that the animals were infected, had inflammation, were treated, and did not have IgG responses.
David and Sam further discussed whether or not there is enough evidence to support the statements.
David expressed his support for Sam treating the patients but disagreed that there is adequate evidence suggesting that those patients had Lyme disease.
Sam acknowledged that available information suggests that those patients have active infection; however, one cannot say definitively whether or not they have Lyme disease.
Kevin suggested that Sam add a qualifying statement to that effect.
Sam agreed to include in the paragraph: “In the absence of definitive evidence, one cannot definitively say if the patients have or do not have Lyme disease,” and he noted that the Working Group could review the revised sentence at the next Working Group meeting.
	David and Gene expressed their acceptance of Sam’s suggested changes.
**Comment 4 from David Walker**
	David and Sam discussed the language of the paragraph starting with “The existing gaps in Lyme disease diagnosis...” David commented that antibiotics will not help those patients with no active *B. burgdorferi* infection.
Sam agreed and noted that the paragraph highlights the need for the development of Lyme disease-specific diagnosis to help health care providers make an accurate diagnosis.
David accepted Sam’s explanation.
**Comment 5 from Pat Smith**
	Pat noted that her comment about Rocky Mountain spotted fever references is the same as the one discussed earlier by the Working Group. She suggested using the same references that will be provided by Ben.
**Comment 6 from Pat Smith**
	Pat commented that the paragraph starting with “Tularemia is caused by the bacterium *Francisella tularensis*” would need some citations, particularly the last sentence (“Over 70% of reported cases are either ulceroglandular or glandular, generally indicating that the infection was caused by the bite of an infected tick or deer fly”).
Ben explained that the Subcommittee report contains references, and he offered to help find the references if necessary.
**Comment 7 from David Walker**
	David commented that ther terms “subclinical” and “asymptomatic” are redundant. Given that “asymptomatic” had already been removed from the paragraph, no change was to be made.
**Comment 8 from Pat Smith**
	Pat suggested adding references (from Subcommittee reports or CDC).
Sam responded that the sentence is a general statement, adding that he feels comfortable with the statement without a reference.
Pat accepted his explanation.
**Comments 9 and 10 from Pat Smith**
	In her comments related to Recommendations 4.4 and 4.5., Pat wanted to know if it is appropriate for the Working Group to list the individual entities.
David responded that those are just examples.
Alternate DFO Kaye Hayes confirmed it is okay to include those entities as examples.**Comment 11 from Pat Smith**
	In her comment, Pat noted that evidence/references are needed to support the last sentence about incentives needed to encourage the development of diagnostic tests.
Dennis noted that he would ask his diagnostics team to help provide a reference to support that statement about lack of interest in developing diagnostics.
**Comment 12 from Pat Smith**
	Pat commented that references are needed for the paragraph.
David explained that the paragraph describes the current situation.
Sam asked David to help provide references.
Dennis and David agreed to help Sam locate references.
At this point Sam asked if the Working Group would need to vote to indicate there will be minority response(s) for this chapter.
Sam and Pat briefly discussed whether or not the Working Group should vote now.
Kevin suggested Sam revise the chapter and the Working Group review and vote on the revised version.
After a brief discussion, Sam decided not to make a motion to vote on Chapter 4.
The Working Group then moved on to review Chapter 5.
Review of Chapter 5: Causes, Pathogenesis, and Pathophysiology
The Working Group briefly reviewed Chapter 5.
**Motion and Vote**
	Given that all previous comments had been satisfactorily addressed, Sam made a motion to accept Chapter 5: Causes, Pathogenesis, and Pathology.
	Scott Commins seconded the motion.
Thirteen members present at the meeting unanimously voted yes to accept Chapter 5, and one member was absent. The motion was passed.
Review of Chapter 6: Treatment
The Working Group reviewed and discussed the comments in Chapter 6.
**Comment 1 from David Walker and Response from Sam Donta**
	David suggested adding a clause at the end of the sentence to address placebo effect.
Sam responded that he would arrange the paragraphs.
**Comment 2 from Pat Smith**
	Pat provided the same comment about references supporting the fatality rate of Rocky Mountain spotted fever. Since the same comment had been discussed earlier, the Working Group moved on to the next comment.
**Comment 3 from Pat Smith**
	Pat suggested adding a reference to support the statement about using doxycycline in children.
Sam asked David to help provide a citation.
**Comment 4 from Pat Smith**
	Pat asked to include references regarding different treatment regimens for babesiosis.
Ben responded that relevant references can be found in the subcommittee report, including the appendices.
**Comment 5 from Pat Smith**
	Pat commented that references are need for resistance to atovaquone and azithromycin.
Sam responded that he would check for references.
**Comment 6 from Pat Smith**
	Pat commented that more information about the tick-borne viruses is needed from CDC or peer-reviewed publications.
Sam responded that the sentence is a general statement, and it does not specify anything that need citation.
Pat suggested providing a link to CDC’s website.
Sam replied that he would look for relevant references; if he was unable to find any, he would add a link to CDC.
**Comment 7 from Pat Smith**
	Pat asked that a reference to be added for the paragraph on tularemia, particularly the sentence starting with “Over 70% of reported cases ...”
Ben agreed to help Sam find relevant references.
The Working Group concluded the discussion of Chapter 6.
Review of Chapter 7: Clinician and Public Education, Patient Access to Care
Gene explained that he did not add detailed comments in Chapter 7 because he has prepared a minority response.
Sam suggested that, because the meeting has already run longer than the scheduled time,  Chapter 7 be reviewed at the next meeting.
Pat asked to finish the chapter.
A few other members expressed their preference for resuming the discussion at the next meeting.
Pat stated that she and Coop had made enough revisions, and she was not sure if they would make any further changes.
Gene made a motion to adjourn the meeting.
Kevin seconded the motion.
Eight members voted yes; two members voted no; two members abstained; and two members were absent. The motion was passed.
Adjournment
Jim announced that the date for the next Working Group meeting will be posted on the Working Group’s website. He then adjourned the meeting at 4:27 pm.
Appendix 1: Tick-Borne Disease Working Group Members
**In alphabetical order:**
**Co-Chair***Leigh Ann Soltysiak*, MS, Founder, Principal, Silverleaf Consulting, LLC; Adjunct Professor, Stevens Institute of Technology, Entrepreneurship Thinking (Present)
**Co-Chair***David Hughes Walker*, MD, Professor, Department of Pathology, the Carmage and Martha Walls Distinguished University Chair in Tropical Diseases; Executive Director, UTMB Center for Biodefense and Emerging Infectious Diseases (Present)
*Charles Benjamin (Ben) Beard*, PhD, Deputy Director, Division of Vector-Borne Diseases, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services; Associate Editor, Emerging Infectious Diseases (Present)—*Susanna N. Visser*, DrPH, MS, Associate Director for Policy, Division of Vector-Borne Diseases, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services (Alternate present)
*CDR Rebecca Bunnell*, MPAS, PA-C, Senior Advisor, Learning and Diffusion Group, Innovation Center, Centers for Medicare and Medicaid Services, U.S. Department of Health and Human Services (Absent) – *CAPT Scott J. Cooper,* MMSc, PA-C, Senior Technical Advisor and Lead Officer for Medicare Hospital Health and Safety Regulations, Centers for Medicare and Medicaid Services, U.S. Department of health and Human Services (Alternate present)
*Scott Palmer Commins*, BS, MD, PhD, Associate Professor of Medicine & Pediatrics University of North Carolina; Member, UNC Food Allergy Initiative, Thurston Research Center (Present)
*Angel M. Davey*, PhD, Program Manager, Tick-Borne Disease Research Program, Congressionally Directed Medical Research Programs, U.S. Department of Defense (Present)
*Dennis M. Dixon*, PhD, Chief, Bacteriology and Mycology Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, U.S. Department of Health and Human Services (Present) - *Samuel (Sam) S. Perdue,* PhD, Section Chief, Basic Sciences and Program Officer, Rickettsial and Related Diseases, Bacteriology and Mycology Branch, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, U.S. Department of Health and Human Services (Alternate present)
*Sam T. Donta*, MD, Professor of Medicine (retired); Consultant, Infectious Diseases (Present)
*CAPT Estella Jones*, DVM, Deputy Director, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, U.S. Department of Health and Human Services (Absent) – *CDR Todd Myers*, PhD, HCLD (ABB), MB (ASCP), Office of Counterterrorism and Emerging Threats, Office of the Chief Scientist, Office of the Commissioner, U.S. Food and Drug Administration, HHS (Alternate present)
*Kevin R. Macaluso*, PhD, MS, Locke Distinguished Chair, Chair of Microbiology and Immunology, College of Medicine, University of South Alabama (Present)
*Adalberto (Beto) Pérez de León*, MS, PhD, Director, Knipling-Bushland U.S. Livestock Insects Research Laboratory, United States Department of Agriculture—Agricultural Research Service (Present)
*Eugene (Gene) David Shapiro,* MD, Professor of Pediatrics, Epidemiology, and Investigative Medicine, Yale University School of Medicine; Vice Chair for Research, Department of Pediatrics; Co-Director of Education, Yale Center for Clinical Investigation; Deputy Director, Yale PhD Program in Investigative Medicine (Present)
*Patricia (Pat) V. Smith*, President, Lyme Disease Association, Inc. (Present)
*Leith Jason States**,* MD, MPH (FMF), Deputy Chief Medical Officer, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services (Absent) – Shahla Jilani, Deputy Chief Medical Officer, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services (Absent)
Appendix 2: HHS Support Staff
*James (Jim) Berger*, MS, MT (ASCP), SBB, Designated Federal Officer, Tick-Borne Disease Working Group, Senior Blood and Tissue Policy Advisor, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services
*Kaye Hayes*, MPA, Alternate Designated Federal Officer, Tick-Borne Disease Working Group, Executive Director, Presidential Advisory Council on HIV/AIDS, Principal Deputy Director, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services
*Chinedu Okeke* MD, MPH-TM, MPA, Senior Policy Advisor, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services
*Debbie Seem*, RN, MPH, Health Policy Advisor, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services
*Lauren Overman*, MPH, Public Health Administration Analyst, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services
*Allison Petkoff,*ORISE Fellow, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services
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 León* 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*

                    
  


Content created by Office of Infectious Disease and HIV/AIDS Policy (OIDP) Content last reviewed November 27, 2020Back to top
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