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                              November 17, 2020, TBDWG Meeting (online)
                              TBDWG November 17, 2020 – Meeting Summary


    

    

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TBDWG November 17, 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, Senior Blood and Tissue Policy Advisor, Office of Infectious Disease and HIV/AIDS Policy (OIDP), Office of the Assistant Secretary for Health (OASH), U.S. Department of Health and Human Services (HHS); Designated Federal Officer (DFO) for the Tick-Borne Disease Working Group, called the meeting to order and welcomed all meeting attendees. Jim then conducted roll call (see Appendix 1 and Appendix 2: Tick-Borne Disease Working Group Members and HHS Support Staff).
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 at 12 pm Eastern, at 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 16
Working Group Co-Chair David Walker welcomed all meeting attendees and commented on how much the 2020 Working Group had accomplished since its inception, thanking members for their continued dedication. He added that the Working Group is nearing completion of the 2020 Report to Congress.
Leigh Ann Soltysiak, MS, Integrated Marketing Communications, Northwestern University; Founder, Silverleaf Consulting, LLC; Entrepreneurial Thinking, Stevens Institute of Technology; Tick-Borne Disease Working Group Co-Chair, welcomed everyone and stated that members can think of today's meeting as the last working meeting. As such, she encouraged members to closely follow the agenda in order to accomplish all of the meeting objectives. She clarified that Meeting 18, scheduled for December 2, 2020, will be reserved for putting finishing touches on the report. Leigh Ann thanked the contractors supporting the Working Group in the writing of its 2020 Report to Congress.
Leigh Ann explained that during Meeting 16, the Working Group reviewed and discussed Chapters 1, 2, 3, 4, 5, 6, 8, 9, 10, 11 and approved five of those chapters.
Meeting 17 Agenda, Goals, and Timeline
Leigh Ann outlined the agenda for today's meeting, including a review of the Working Group's mission, vision, and values; an opportunity to hear public comments; a presentation of written public comments received by the Working Group; as well as a review and discussion of Chapter 7, the Executive Summary, Chapters 1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, and the Appendices.
David explained that the purpose of the meeting is to review and discuss the chapters and any remaining feedback, then take a vote on the chapters in their entirety.
Leigh Ann presented the Working Group's timeline, reflecting on how much the Working Group had accomplished during its tenure. She reiterated that the purpose of Meeting 18 (on December 2, 2020) will be to resolve any final issues, so the vendor can finalize the report for submission to Congress and the HHS Secretary and for posting 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.
Announcements
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.
Also, in response to questions he had received from the public, Jim asked that anyone interested in serving on a future Working Group subcommittee hold off on applying until the 2022 Working Group has been formed, as those members will ultimately decide whether or not to enlist the help of subcommittees in writing the 2022 Report to Congress.
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 meetings; and
			The comments received by the Working Group.
	Make recommendations to the Secretary regarding any appropriate changes or improvements to such activities and research; and
	Solicit input from States, localities, and non-governmental entities, including organizations representing patients, health care providers, researchers, and industry regarding scientific advances, research questions, surveillance activities, and emerging strains of pathogenic organisms.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).
Leigh Ann added that because the Working Group had been receiving a significant number of written public comments, it was taking more time than usual to process them and post them to the Working Group's website. She thanked members of the public for their patience and noted that sending group comments in one email rather than multiple individual emails would help ensure a faster turn-around time.
Ten members of the public provided comments over the phone.
*Janice Sutton:* Janice noted that she had provided comments at the Working Group's last meeting, adding that her daughter remains ill with neurobartonellosis. She explained that from ages 14 to 21, her daughter has seen 20 doctors yet has not been given effective care. She questioned the Working Group's membership, noting that anyone with financial conflicts of interest or who denies the existence of chronic Lyme disease should not be included. She made the following recommendations to the Working Group:
Include nurses, veterinarians, and International Lyme and Associated Diseases Society (ILADS)-trained physicians in the membership;
	Assign homework, whereby members read and then discuss the most recent research; and
	Hold shorter public meetings.She highlighted that patients like her daughter are suffering and need the help of people who have a sincere desire to understand the problems they face.
*Yan Zelener:* Yan stated that he is the director of science for LymeTV. He commented that there is a prevailing assumption that all Lyme disease patients—regardless of their symptoms and symptom severity—are confronted with the same pathogen, thus neglecting the clinical implications of genetic variations of *Borrelia* species and strains. He added that such clinical variations are seen in different pathogen strains of HIV, malaria, and tuberculosis. Citing studies to support his comments, Yan also discussed the impact of different *Borrelia* genotypes and their effect on whether or not an *erythema migrans* (EM) rash is present. He explained that around 40-50% of Maine residents with Lyme disease present with an EM rash, which, he noted, is significantly less than the statistics provided on the Centers for Disease Control and Prevention (CDC) website. He encouraged the Working Group to recommend that CDC update its website with more accurate information about the prevalence of EM rashes. He noted that much is unknown about variations in the *Borrelia* genome and suggested that some species may confer resistance to antibiotics. He concluded that, in the absence of tests that differentiate between strains that produce mild versus severe symptoms, clinicians and patients should be informed about this variability of risk, and he encouraged the Working Group to reframe its presentation of risk on the basis of genetics.
*Jane Barrows:* Jane stated that she represents the nonprofit Lyme Newport in Rhode Island. She described her experience with Lyme disease, noting that it began with a sudden onset of severe illness in 2007 and resulted in two and a half months of disabling sickness. She commented that she was able to get treatment through a doctor in her state who understood Lyme disease.
Jane explained how her experience led her to create a nonprofit support group through which she has connected with more than 400 patients who are desperate for a diagnosis and treatment. However, she added, most of them have been told that they do not have Lyme disease. Jane stated that the medical system in her state follows CDC information and the Infectious Diseases Society of America (IDSA) treatment guidelines, which she described as outdated and inadequate for treating complex tick-borne diseases and coinfections. She highlighted the importance of clinician education, insurance coverage for tick-borne disease patients, and protection for clinicians who treat according to ILADS guidelines, which she concluded are more appropriate for patients with complex illness caused by ticks and other probable vectors.
*Andrea Jackson:* Andrea referenced a lawsuit involving IDSA and multiple insurance companies, and expressed concern about corruption in the Lyme disease medical community and encouraged whistleblowers to come forward. Andrea commented that three minutes is not long enough for oral public comment and criticized how written public comments are reviewed and presented at Working Group meetings. She identified specific public comments that she felt should be made public. She suggested that instead of public comments, a debate perhaps should be held involving CDC scientists and physicians and scientists who represent Lyme disease patients. Andrea expressed frustration that 40 years have passed yet little progress has been made in the area of diagnostics and vaccines, and she asked why the Working Group was convened if it were not for the seriousness of persistent Lyme disease. She criticized some Working Group members and praised others for their work on the 2020 Report.
*Lorraine Johnson:* Lorraine stated that she is CEO of LymeDisease.org and principal investigator of the MyLymeData patient registry and research platform. She commented that, despite its high incidence, Lyme disease clinical trial research funding is less than that of leprosy. She stated that the pharmaceutical industry has not invested in new treatment drugs and NIH has not funded clinical trials for over 20 years, adding that funding for Lyme disease is on par with that of rare diseases. Lorraine explained the importance of using research engines that link patient registries, biorepositories, and clinical data networks to facilitate and accelerate the pace of research. She described similar work she has done through MyLymeData and highlighted successful outcomes. Lorraine commented on the lack of feasibility of conducting multiple sequential randomized control trials and offered quotes to that effect from notable people in the field. She emphasized that patients cannot wait for research that is unlikely to occur and underscored that patient registries such as MyLymeData play an important role in promoting research to come up with treatment solutions that will help Lyme disease patients today.
*Mary Lorusso-DiBara:* Mary commented that many members of her family have been impacted by chronic vector-borne diseases, specifically *Bartonella* infection, and that transmission may have occurred through her mother. She described her sister's seven-year experience with the illness, commenting that she saw over 22 practitioners and was consistently misdiagnosed. Mary explained that, after experiencing financial hardship, debilitating symptoms, and emotional distress, her sister finally received effective treatment through a Lyme-literate doctor. Mary commented that many chronically ill patients consider taking their own lives because their suffering is unbearable, and they are made to feel that they have caused their own suffering. She urged Working Group members to set personal agendas aside, refrain from arguing, and prioritize patients suffering with chronic illness. She added that her family has received effective treatment from clinicians who follow ILADS guidelines, and her family members have formed a nonprofit (Northeast Lyme and Associated Diseases), which will be operational in 2021. Mary concluded that her brother cannot participate because he was undiagnosed until age 55 and now has brain atrophy and dementia.
*Phyllis Mervine:* Phyllis stated that she is founder and president of LymeDisease.org. She praised the current patient representative and requested that the Working Group have greater patient representation in the 2022 membership and more transparency in the member selection process. She commented that a petition submitted to Health and Human Services regarding current membership has not been addressed. Phyllis requested that CDC revert back to county-based Lyme disease incidence maps so that clinicians and the public who reside in high-incidence counties within low-incidence states are aware of disease risk. She also urged CDC to let clinicians know that there are two standards of care, as most chronically ill patients seek treatment from clinicians who follow ILADS guidelines. Phyllis stressed that tick-borne disease educational materials for clinicians should present both IDSA and ILADS perspectives. She concluded by stating that her neighbor with amyotrophic lateral sclerosis (ALS) and a late-stage diagnosis of tick-borne diseases died at age 72.
*Carl Tuttle:* Carl noted that he is a member of the New Hampshire HB490 commission to study Lyme disease and explained that his comment pertains to a Working Group member's statement at the July meeting related to persistent infection. To contradict the statement, Carl read excerpts from five publications related to persistent *Borrelia burgdorferi* infection and highlighted the challenges of treating late-stage Lyme disease.
*Lucy Barnes:* Lucy praised some members of the Working Group for their contributions and thanked HHS staff for being helpful. She criticized the viewpoints of other members. She provided multiple quotes from patients in Florida who recounted stories of being misdiagnosed or denied treatment for chronic Lyme disease because their clinicians did not believe it exists in the state. Lucy asked if the Working Group's report will help address the issue of chronic Lyme disease. She stated that many studies have demonstrated the presence and transmission of Lyme disease and many other tick-borne pathogens in the state. She provided her contact information for anyone seeking more information about the specific pathogens.
*Dorothy Leland:* Dorothy commented that she is the vice president of LymeDisease.org and explained the organization's mission. She highlighted the importance of putting the patient at the center of medical care, research, and healthcare policy and expressed criticism of Working Group members who do not make this the primary focus and who do not acknowledge chronic Lyme disease. She described how the healthcare system fails patients with Lyme disease in terms of both diagnosis during the acute stage and treatment when the illness becomes chronic. She drew a parallel between patients with chronic Lyme disease and those who have long-term COVID-19 symptoms. She cited chronic illness as a significant percentage of medical costs, adding that it is straining the American medical system. She stated that insurance companies may save money up front by denying coverage for treatment; however, she concluded, society pays the cost in other ways, including lost productivity, broken families, and social services. She encouraged the Working Group members to consider the following question: Will this report help patients get better?
Public Comments Subcommittee Update
Angel M. Davey, PhD, Program Manager, Tick-Borne Disease Research Program, Congressionally Directed Medical Research Programs, U.S. Department of Defense read the disclaimer and explained how public comments are received and processed. She emphasized that key themes of each month's public comments have been presented at Working Group public meetings, and that detailed comments can be found on the Tick-Borne Disease Working Group website. She then provided a summary of key themes and priority areas raised by members of the public in October.
Chapter 7: Public and Clinician Education, Patient Access to Care—Review and Discussion
CAPT Scott J. Cooper, MMSc, PA-C, Senior Technical Advisor and Lead Officer for Medicare Hospital Health and Safety Regulations, Centers for Medicare & Medicaid Services, U.S. Department of Health and Human Services, reviewed some of the comments that had been made to the chapter since the previous meeting and agreed to implement the first suggestion from David to correct a percentage in the first paragraph under the heading "Lyme Disease." However, he concluded that the rest of David's comments had already been discussed at previous meetings and questioned the value of reviewing them again.
David responded that his comments asserting that chapter content does not support the recommendations have not been addressed.
Coop disagreed. He reiterated that the issue had already been discussed, adding that affordable access to care is included in the Working Group's Charter.
David suggested that the 2022 Working Group ensure access to care is included in their report recommendations. He asked that his comments for Chapter 7 be reviewed at today's meeting.
Patricia (Pat) V. Smith, President, Lyme Disease Association, Inc., responded that she and Coop would not be reviewing the comments, stating that many of them are not specific, and they have already been discussed and taken under consideration.
David responded that the issues he has identified have not been addressed.
Pat and David continued to disagree on the process and actions taken.
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, pointed out that there is a fundamental disagreement on the overall contents of the chapter that cannot be resolved by further discussion of individual comments. He added that the Working Group has not been able to achieve consensus on Chapter 7. He commented that the content is not balanced, and he expressed his discomfort with the depiction and interpretation of the clinical trials because the focus is on minority viewpoints instead of main evidence. He suggested that members proceed with a vote on the chapter.
Pat expressed disappointment and frustration in the process and in the way Chapter 7 has been received by some of the Working Group members despite revisions she and Coop had made to the chapter. She stated that Chapter 7 has been scrutinized more heavily than other chapters. She stressed the urgency of helping patients who are suffering, adding that not enough has been done to help them.
Dennis agreed that patient suffering must be addressed and emphasized the importance of conducting rigorous research to understand the mechanism of disease and the basic translational clinical needs.
David also agreed that patients need help. He stated that to better help patients, understanding the real underlying cause is needed. He explained that the issue with the patient survey mentioned in Chapter 7 is that some survey participants may have diseases other than Lyme disease, which is important to understand.
Pat explained the process by which patients are selected for the patient registry referenced in Chapter 7.
Motion and discussion
Sam T. Donta, MD, Professor of Medicine (retired); Consultant, Infectious Diseases, made a motion to vote on Chapter 7 in its entirety with minor edits previously discussed.
David suggested splitting the motion into two parts: one related to recommendations and the other to chapter contents.
Sam commented that the recommendations have already been voted on, noting that his motion stands.
Pat seconded the motion.
Leigh Ann commented that there have already been lengthy discussions on these topics and reminded the group that today's meeting is one of the last steps in bringing the entire report process to a close.
Dennis explained his understanding of the process, that is, if the chapter is voted down, replacement content would be generated to support the recommendations. He noted that he did not think the chapter would be deleted from the report. He added that, if the chapter passes with members voting against it, those members will be able to write minority responses.
Pat urged the Working Group to proceed with the vote.
Sam encouraged members to vote in favor of the chapter as written, noting that those who vote against it can write a minority response. He stated that there is not enough time to write replacement content if the chapter is voted down.
Leigh Ann asked Dennis to repeat his understanding of the process.
Dennis did so and asked DFO Jim Berger to comment.
Jim responded that Dennis is correct.
Pat stated that David's comments in Chapter 7 should have been added to chapter prior to the October meeting when it was originally slated to be discussed. She again asked the Working Group to vote.
Leigh Ann emphasized the need to clarify the process for handling the chapter. She suggested that it is too late to write replacement content and encouraged members to instead take a vote and write minority responses if appropriate.
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, asked for clarification on the process of writing a minority response.
Jim explained that in order to write a minority response, members must vote against a chapter or a section of a chapter.
Pat and Coop reminded the group that there is a motion on the floor.
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, stated that CDC supports the recommendations in the chapter; however, he added, the chapter lacks balance and does not discuss limitations of the patient registry. He stated that, although member comments and concerns have been discussed previously, they have not been adequately addressed.
Sam said that comments were made about the content without offering alternative language.
Coop agreed and urged the group to take a vote.
Dennis clarified that individual comments can be addressed with minor edits, but overall tone and balance of the contents requires more extensive revision. He commented on the portrayal of the NIH clinical trials as an example. He explained the design and conclusions of each trial, including the European trial, noting that Chapter 7 does not accurately reflect that information.
Pat responded that these issues had already been discussed (including the reasoning for excluding the European trial in Chapter 7), and revisions to the section on NIH clinical trials had been made. She reminded the group of the motion and second on the floor.
Dennis commented that the revisions to the chapter did not adequately address members' concerns.
Pat disagreed.
David expressed concern about potential harms if physicians were led to provide ineffective treatment options to their patients.
Sam explained the limitations of the European clinical trial.
Pat defended the ILADS guidelines, and pointed out the importance of clinical judgment and patient experiences.
Dennis highlighted that a major finding of the Klempner trial was that all patients who met the eligibility criteria for post-treatment Lyme disease syndrome were ill to the level of someone with congestive heart failure. He noted that everyone is in agreement about the gravity of illness faced by the patients involved in the trials.
Leigh Ann asked how a member can write a minority response on just one section of the chapter.
Jim explained that, at this point, members have to vote for or against the chapter in order to write a minority response.
Dennis added that members can specify in their minority responses which section they disagree with.
The group continued to discuss the process of submitting minority responses and whether or not members could vote against sections of the report at this point rather than against the entire chapter.
Coop and Pat commented that members had opportunities to vote against sections of the chapter earlier in the process but did not do so.
Leigh Ann countered that the official process for submitting a minority response had not been established until the October meeting. She added that until that point, members may have been under the impression that they could submit a minority response for a specific section even if they had voted in favor of the entire chapter.
Pat questioned the decision-making process regarding minority responses and reiterated that the co-leads will not make any changes.
Sam and Dennis suggested the group proceed with the vote.
Vote
Eight members voted yes to approve Chapter 7 in its entirety. Six members voted no. The motion passed.
Two members who voted no commented that they could not support the chapter as written because it needs a more balanced presentation.
Another member who voted no stated that consensus had not been achieved on chapter contents.
A fourth member who voted no commented that there were issues with the table that compares treatment guidelines.
Four of eight members who voted yes clarified that they voted yes to include the chapter in the report with the understanding that there will be minority responses, and they noted that they understood the rationale and would support minority responses to be written.
Executive Summary— Review and Discussion
Jennifer Gillissen, Kauffman and Associates, Inc. presented the Executive Summary in PDF template format.
Suggested Revision by Sam Donta
Sam proposed revising the first line to read: "The Tick-Borne Disease Working Group 2020 Report to Congress Report addresses continuing key gaps in the diagnosis and treatment of Lyme disease and adds additional focus on other tick-borne diseases and conditions."
David commented that the existing content already conveys the meaning in Sam's proposed language.
Motion
Sam made a motion to replace the first sentence with his proposed language.
Coop seconded the motion.
Vote
Twelve members voted yes to replace the first sentence with the following statement: "The Tick-Borne Disease Working Group 2020 Report to Congress Report addresses continuing key gaps in the diagnosis and treatment of Lyme disease and adds additional focus on other tick-borne diseases and conditions." One member voted no, and one member abstained. The motion passed.
Comment 1 from Pat Smith
Pat commented that there is no other mention of fiftyfold under-reporting for ehrlichiosis elsewhere in the report, adding that the study cited included only 29 patients, pertains to a small geographic area in Missouri, and does not support the fiftyfold statistic stated in the Executive Summary.
David described the study, noting that it is the only active surveillance study that has been conducted for almost any tick-borne disease. He clarified that the study gave a range of tenfold and one hundredfold under-reporting, and fiftyfold represents the median.
Pat commented that she did not see any mention of "fiftyfold" in the study, the data are from the 1990s, and the study involved only a small group of patients.
David reiterated that fiftyfold represents the median of the range provided in the study.
Coop asked if the reference in question appears only in the Executive Summary.
David replied that it does not.
Sam questioned if the level of detail is necessary for the Executive Summary.
Motion
Sam made a motion to change "fiftyfold" to "tenfold to one hundredfold."
David seconded the motion.
Vote
Thirteen members voted yes to change "fiftyfold" to "tenfold to one hundredfold." One member abstained. The motion passed.
Comment 2 from Pat Smith
Pat explained her comment regarding the number of pathogens transmitted by blacklegged and lone star ticks and asked if the numbers provided are accurate.
Pat, David, and Sam discussed which pathogens were being counted.
Motion and Discussion
Sam made a motion to revise the language to read as follows: "...blacklegged ticks, which transmit Lyme disease as well as seven other known infections, and lone star ticks, which transmit five other known infections."
Pat responded that she would second the motion. She further commented that the numbers may not be accurate even in the revised language. She asked the CDC representative (Ben Beard) to comment on the accuracy.
Ben responded by asking the group if providing the exact pathogen count for each vector tick is perhaps too detailed for the Executive Summary. He clarified that the main concern is the expanding range of ticks and the growing list of pathogens they carry. He suggested revising the language to that effect.
Pat agreed to Ben's suggestion as long as the statement is accurate.
Ben stated that he would write replacement text following the meeting.
Sam replied that he would like to proceed with his motion.
Pat commented that she may have seconded the motion and asked if the number seven in Sam's motion includes Lyme disease.
Ben stated that tularemia is not transmitted by *Ixodes scapularis*.
Adalberto (Beto) Pérez de León, DVM, MS, PhD, Director, San Joaquin Valley Agricultural Sciences Center, United States Department of Agriculture - Agricultural Research Service, agreed with Ben that the statement should be generalized and not overly detailed.
Leigh Ann recommended avoiding introducing new content in the Executive Summary.
Kevin R. Macaluso, PhD, MS, Locke Distinguished Chair, Chair of Microbiology and Immunology, College of Medicine, University of South Alabama, commented that because the geographic ranges of blacklegged and lone star ticks are expanding, the statement should be more general.
Motion Withdrawn
Sam and Pat agreed to have Ben write a more general statement. Sam withdrew his motion, and Pat withdrew her second.
Pat suggested that Ben reference Table 1 (Tick-Borne Diseases and Conditions Currently Recognized in the United States) in his revised language.
Ben agreed.
Ben proposed replacing the existing language that specifies the number of pathogens transmitted by blacklegged and lone star ticks with the following statements: "The geographic range of both blacklegged ticks and lone star ticks has expanded greatly over the last 20 years. Additionally, the numbers of pathogens that are now known to be carried by these ticks and conditions associated with tick bites, such as Alpha-gal Syndrome, have increased significantly. Consequently, more and more people are suffering from tick-associated illnesses each year."
New Motion
David motioned to accept Ben's proposed language.
Kevin seconded the motion.
Vote
Fourteen members voted yes to accept Ben's proposed language.
Comment 3 from Pat Smith
Pat and Coop asked about the usage of the terms ehrlichiosis versus human monocytotropic ehrlichiosis and anaplasmosis versus human granulocytotropic anaplasmosis, and expressed that the more current terms should be used.
David responded that the older terms are still in use and are more specific about the life-threatening forms of infection.
Ben clarified that there are several *Ehrlichia* pathogens but cautioned against providing too much detail in the Executive summary.
Coop and Ben stated that they are comfortable with leaving the content as it is written.
Comment 4 from Pat Smith
Pat explained that more research is needed not only to guide the approach to acute disease, but also to prevent death.
Motion
Pat made a motion to add "and to prevent death" at the end of the sentence that begins "Yet because not all patients recover..."
Coop seconded the motion.
Vote
Fourteen members voted yes to add "and to prevent death" at the end of the sentence that begins "Yet because not all patients recover..." The motion passed.
The Working Group discussed two minor editorial revisions, then moved on to the next comment.
Comment 5 from Pat Smith
Pat explained that in the discussion about the Federal Inventory, there should be a reference to the appendix that contains the survey. She added that there should also be a statement that the inventory results will be publicly available on the Tick-Borne Disease Working Group website, including the url.
David questioned if including that information may be too detailed for the Executive Summary.
Pat replied that her suggested statement could be placed in the Federal Inventory chapter, as long as it is featured somewhere in the report.
Additional Comment from Scott Cooper
Coop asked that references to "Centers for Medicare and Medicaid" be changed to "Centers for Medicare & Medicaid Services" and "Veterans Affairs" be changed to "Department of Veterans Affairs." He noted that references to departments and agencies may be inaccurate and asked that they be verified.
Vote to Accept the Executive Summary in Its Entirety
Fourteen members voted yes to accept the Executive Summary in its entirety, including the revisions discussed at this meeting.
Chapter 1: Background—Review
Jennifer reviewed minor revisions that had been made to Chapter 1: Background since the previous meeting, noting that the chapter was already voted on and approved by the Working Group.
Chapter 2: Methods—Review
Jennifer reviewed minor revisions that had been made to Chapter 2: Methods since the previous meeting, noting that the chapter was already voted on and approved by the Working Group.
Chapter 3: Tick Biology, Ecology, and Control—Review
Jennifer reviewed revisions that had been made to Chapter 3: Tick Biology, Ecology, and Control since the previous meeting.
Motion and Vote to Accept Chapter 3 in Its Entirety
Pat made a motion to accept Chapter 3 as presented.
Beto seconded the motion.
Thirteen members voted yes to accept Chapter 3 in its entirety (as presented). One member was absent. The motion passed.
Chapter 4: Clinical Manifestations, Diagnosis, and Diagnostics—Review and Discussion
Jennifer reviewed revisions that had been made to Chapter 4: Clinical Manifestations, Diagnosis, and Diagnostics since the previous meeting. Sam commented that the majority of the changes related to references.
Comment by Pat Smith
Pat stated that it was unclear to her how the reference to the Presidential Advisory Council supported the content in the rationale for Recommendation 4.5.
Dennis clarified the Presidential Advisory Council's report includes a chapter on the difficulty of advancing diagnostics due to lack of resources and investment.
Sam questioned the relevance of the reference, adding that he did not have a strong preference about keeping it or deleting it.
Dennis responded that he provided the reference based on the Working Group's discussion at the last meeting. He added that it is not an essential reference and could be removed if the co-leads prefer.
Pat stated her preference to remove the reference.
Todd explained that the paragraph is intended to draw a parallel between the area of antibiotic resistance, which has required market incentives in order to make diagnostic advancements, and human monocytotropic ehrlichiosis.
Sam noted that combatting antibiotic resistance is favorable and advocated for keeping the Presidential Advisor Council reference.
Pat agreed to keep the reference.
Motion and Vote to Accept Chapter 4 in Its Entirety
Sam made a motion to accept Chapter 4 as presented.
Pat seconded the motion.
Leigh Ann reminded the Working Group that, although Gene was not present at the time of the vote, his intention was to vote no on accepting Chapter 4 as written.
Eleven members voted yes to accept Chapter 4 in its entirety as presented. One member abstained; one member voted no; and one member was absent. The motion passed.
Chapter 5: Causes, Pathogenesis, and Pathophysiology—Review
Jennifer presented Chapter 5: Causes, Pathogenesis, and Pathophysiology, noting that no changes had been made since the previous meeting, and the chapter was already voted on and approved by the Working Group.
Pat suggested one minor revision (changing "Ig" to IgG"); however, the group determined that the language is correct as written.
Chapter 6: Treatment—Review and Discussion
Jennifer reviewed revisions that had been made to Chapter 6: Treatment since the previous meeting.
Comment 1 from Pat Smith
Pat commented that the Sosa-Gutierrez reference does not support the statements in the text.
Sam suggested removing the reference.
David agreed.
Comment 2 from Pat Smith
Pat inquired about the 10-15% case fatality rate for Powassan virus and the CDC citation provided to support it.
Ben explained that the rate varies each year, and 10-15% is an accurate range based on those annual rates. He provided the following link to show where the annual rates came from: https://www.cdc.gov/powassan/statistics.html.
Sam stated that 10-19% would also be accurate, and that he was comfortable with the language as written.
The Working Group decided to leave the statement as written.
Motion and Vote to Accept Chapter 6 in Its Entirety
Sam made a motion to accept Chapter 6 in its entirety.
Leigh Ann seconded the motion.
Eleven members voted yes to accept Chapter 6 in its entirety, including the removal of the reference identified during the discussion. Three members were absent.
Chapter 8: Epidemiology and Surveillance—Review and Discussion
After a short break, DFO Jim Berger conducted roll call, and the Working Group resumed the meeting with a quorum.
Ben reviewed revisions that had been made to Chapter 8: Epidemiology and Surveillance since the previous meeting.
Comment 1 from Path Smith
Pat asked if the CDC county-level surveillance data for tick-borne diseases other than Lyme disease will be made publicly available.
Ben replied that county-level data are collected for other tick-borne diseases, but that he is uncertain what the current status is. He clarified that the data are state-owned, so they can be obtained from each state. He noted that there is a data use agreement between CDC, the Council of State and Territorial Epidemiologists, and the individual states. He added that he was unsure if or when the data will be available through CDC.
Pat expressed concern about the availability of the data through CDC. She asked how someone could get a copy of the data use agreement.
Ben responded that in the case of low-incidence diseases, county-level data are not released in order to protect the identity of the individual patients. He added that he could provide a link to CDC's website where information is provided on reporting, surveillance, and their legality.
No change was made to the content that prompted Pat's comment.
Comment 2 from Pat Smith
Pat asked that a statement be added to the second paragraph under "Major Challenges and Issues" about the limitation of testing, specifically that there are no commercially available tests for complexed antibodies. She provided two references to support her proposed insertion.
Ben pointed out that the paragraph includes a discussion of limitations. He suggested that Pat write the sentence and add it to the paragraph.
Pat stated that she would like to have her addition included.
Comment 3 from Pat Smith
Pat explained that her comment about under-reporting of human monocytotropic ehrlichiosis by fiftyfold had already been discussed during the discussion of the Executive Summary.
[Note: At this point in the meeting, a motion was made and seconded to vote on and accept the chapter in its entirety. However, the vote was interrupted in order to accommodate a member who wanted to comment on Chapter 8 but was not able to do so because of technical difficulties. For continuity and clarity, the comments are provided below, followed by the complete vote, which was agreed upon by the motioner and the seconder.]
Additional Comment by Sam Donta
Regarding the second paragraph under "Major Challenges and Issues," Sam stressed that the development of new diagnostic tests is especially important for chronic/persistent Lyme disease and urged the Working Group to add "and all of its stages" to the sentence that begins "Similarly, there is a need for new diagnostic tests..."
Dennis noted that it is not currently possible to determine whether or not patients with chronic or persistent Lyme have active infection and suggested instead adding "by currently available tests" to the sentence ending "but who no longer have active infection."
Sam agreed to Dennis's revision as a replacement for the one he had suggested.
Leigh Ann noted that the word "diagnostic" appears twice and suggested removing the redundancy.
Motion and Vote to Accept Chapter 8 in Its Entirety
Ben made a motion to accept Chapter 8 in its entirety, including the insertions from Pat and Dennis.
Scott Palmer Commins, BS, MD, PhD, Associate Professor of Medicine & Pediatrics University of North Carolina; Member, UNC Food Allergy Initiative, Thurston Research Center, seconded the motion.
Twelve members voted yes to accept Chapter 8 in its entirety, including the removal of the reference identified during the discussion. Two members were absent.
Chapter 9: Federal Inventory—Review
Jennifer reviewed revisions that had been made to Chapter 9: Federal Inventory since the previous meeting, noting that the chapter had already been voted on and approved by the Working Group.
Pat reminded the group of her earlier comment about including the url to the Federal Inventory results on the Tick-Borne Disease Working Group website.
Coop once again asked that the naming of the Federal agencies and departments be checked for accuracy.
Chapter 10: Public Input— Review and Discussion
Jennifer presented Chapter 10: Public Input, and Angel made note of the minor edits that had been made since the previous meeting.
Leigh Ann suggested that the new patient/clinician graphic be placed at the beginning of the chapter rather than at the end.
Sam and Scott agreed.
Motion and Vote to Accept Chapter 10 in Its Entirety
Sam made a motion to accept Chapter 10 in its entirety.
David seconded the motion.
Fourteen members voted yes to accept Chapter 10 in its entirety.
Chapter 11: Looking Forward—Review and Discussion
Jennifer presented minor revisions that had been made to Chapter 11: Looking Forward since the previous meeting, noting that the chapter had already been voted on and approved by the Working Group. She commented that there was a Minority Response that would be added to the end of the chapter.
Conclusion—Review and Discussion
Jennifer presented Conclusion, noting that there were no revisions or comments since the previous meeting.
Motion and Vote to Accept Conclusion in Its Entirety
David made a motion to accept Conclusion in its entirety.
Beto seconded the motion.
Fourteen members voted yes to accept Conclusion in its entirety.
Appendices—Review and Discussion
Jennifer presented revisions that had been made to the Appendices since the previous meeting. She noted that the acronyms and abbreviations will be doubled checked once more, and the references are being continually updated and cross-referenced with the citations in the text.
Members asked for a few additional revisions to their titles in Appendices A and B.
Pat requested that non-Federal Working Group member categories be added under member names in Appendix A.
Front and Back Covers—Review and Discussion
Jennifer presented revisions that had been made to the front and back covers since the previous meeting. She asked the Working Group members to comment on four options for the primary photo that had been sent to them prior to today's meeting.
After a brief discussion, the Working Group decided to replace the primary image with the photo of the family walking through tall grass in boots.
Beto pointed out that the "Help us find a cure" photo appears on both the front and back cover and suggested replacing the photo on the back cover with the image of a tick on a blade of grass.
David recommended replacing the *Borrelia* photo on the back cover with the photo of a tick warning sign.
Table of Contents—Review and Discussion
Jennifer presented revisions that had been made to the table of contents since the previous meeting.
Members briefly discussed whether or not to include on this page a link to the subcommittee reports that are available on the Working Group's website but ultimately decided against it.
Recap of Meeting #17 and Next Steps
David reviewed what had taken place during Meeting #17.
Leigh Ann explained that the next meeting would take place on December 2, 2020 with the purpose of reviewing and approving the final report.
Ben asked about the process for generating minority responses for any chapters against which members had voted during today's meeting.
Jennifer responded that her team would be in contact with the members who had voted in the minority to discuss the process and determine due dates.
Members discussed whether or not minority responses should be consolidated, given that there would likely be multiple responses within one chapter.
Ben commented that the report may not be well received by the intended audience if it includes multiple minority responses that convey a similar message.
Sam asked if members will be expected to sign their minority responses.
Leigh Ann responded that they would be anonymous.
Dennis suggested that minority responses be written by individuals rather than consolidated in order to convey the unique concerns and opinions expressed by members who cast a minority vote.
Leigh Ann recommended that each member write their own minority response then determine how to proceed.
Leigh Ann thanked members for their hard work both today and throughout the process.
Pat requested that the next meeting include an update on the new HHS project, LymeX.
Jim agreed to include such an update in the agenda.
Adjournment
Jim adjourned the meeting at 2:16pm Eastern.
Appendix 1: Tick-Borne Disease Working Group Members
In alphabetical order:
Co-Chair
*Leigh Ann Soltysiak*, MS, Integrated Marketing Communications, Northwestern University; Founder, Silverleaf Consulting, LLC; Entrepreneurial Thinking, Stevens Institute of Technology (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 (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)
*Scott Palmer Commins*, BS, MD, PhD, Associate Professor of Medicine & Pediatrics University of North Carolina; Member, UNC Food Allergy Initiative, Thurston Research Center (Present)
*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 (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*, DVM, MS, PhD, Director, San Joaquin Valley Agricultural Sciences Center, United States Department of Agriculture - Agricultural Research Service (Present)
*Eugene (Gene) David Shapiro,* MD, Professor of Pediatrics, Epidemiology, and Investigative Medicine, Yale University School of Medicine; Vice Chair for Research, Department of Pediatrics; Co-Director of Education, Yale Center for Clinical Investigation; Deputy Director, Yale PhD Program in Investigative Medicine (Present)
*Patricia (Pat) V. Smith*, President, Lyme Disease Association, Inc. (Present)
*Leith Jason States,* MD, MPH (FMF), Deputy Chief Medical Officer, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services (Present) – Shahla Jilani, Deputy Chief Medical Officer, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services (Alternate Absent)
Appendix 2: HHS Support Staff and Contractor
In alphabetical order:
*James (Jim) Berger*, MS, MT(ASCP), SBB, Designated Federal Officer, Tick-Borne Disease Working Group Senior Blood and Tissue Policy Advisor, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services
*Kaye Hayes*, MPA, Alternate Designated Federal Officer, Tick-Borne Disease Working Group, Executive Director, Presidential Advisory Council on HIV/AIDS, Principal Deputy Director, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services, 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
*Chinedu Okeke*, MD, MPH-TM, MPA, Senior Policy Advisor, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services
*Lauren Overman,* MPH, CPH,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
*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
Contractor
*Jennifer Gillissen*, Kauffman and Associates, Inc.
Appendix 3: Public Comments Subcommittee Members
In alphabetical order:
Subcommittee Co-Chairs
***Scott Palmer Commins,*** MD, PhD, Physician and Scientist, University of North Carolina Health Care
***Angel M. Davey,*** PhD, Program Manager, Tick-Borne Disease Research Program, Congressionally Directed Medical Research Programs, U.S. Department of Defense
***Leigh Ann Soltysiak,*** MS, Integrated Marketing Communications, Northwestern University; Founder, Silverleaf Consulting, LLC; Entrepreneurial Thinking, Stevens Institute of Technology
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 December 16, 2020Back to top
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