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, Roll Call, and Introduction
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), welcomed all meeting attendees and called the meeting to order. Jim then conducted roll call (see Appendix 1 and Appendix 2: Tick-Borne Disease Working Group Members and HHS Support Staff). All 14 members of the Tick-Borne Disease Working Group were present.
Co-Chair Welcome and Recap of Meeting 17
David Hughes Walker, MD, Professor, Department of Pathology, the Carmage and Martha Walls Distinguished University Chair in Tropical Diseases; Executive Director, UTMB Center for Biodefense and Emerging Infectious Diseases; Tick-Borne Disease Working Group Co-Chair, welcomed all meeting attendees and asked all Working Group members to reflect on the Working Group’s accomplishment.
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, reflected upon ADM Brett Giroir’s remarks at the Working Group’s inaugural meeting in January 2019 on the importance of tick-borne diseases. She stated that ADM Giroir assured that the Tick-Borne Disease Working Group’s work, assessment, and recommendations matter. Leigh Ann said as a recovered patient, it was inspiring to hear ADM Giroir state that the time to take action is now. She noted that today the Working Group will finalize the report and afterward submit the report to the HHS Secretary and Congress, knowing that appropriate actions will occur. Leigh Ann expressed her excitement for the public, patients, recovered patients, patient advocates, researchers, scientists, health care providers, policy makers, industry, as well as all the stakeholders and potential beneficiaries.
David stated that all chapters of the report were approved during the Working Group’s public meeting 17.
Meeting 18 Agenda and Goals
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 LymeX; and a final review of the report, including the Executive Summary, Chapters 1-11, Conclusion, the Appendices, and the front and back covers. She stated that the goal of the final review is to conduct final voting and put forth the report.
Working Group Objectives and Duties
Leigh Ann then reviewed the Working Group’s duties, 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.
David explained that the goal of today’s meeting is to review and approve the Working Group’s final report to Congress.
Leigh Ann presented the Working Group’s timeline and reiterated that the purpose of today’s meeting is to review and vote on the final report and approve it for submission to Congress and the HHS Secretary.
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 made an announcement regarding the amended Federal Register Notice published on November 4th, 2020 seeking 2022 Working Group members. He stated that all applications must be received by his office no later than 5 pm Eastern Standard Time on December 5, 2020. Jim encouraged everyone to share the information with those who might be interested in serving on the Tick-Borne Disease Working Group.
Jim then stated a request from the HHS Office of General Council, which had reviewed the Working Group’s report and the minority responses. Jim explained that the Office of the General Council asked the authors of the minority responses to reconsider if their statements about individual Working Group members should remain in the minority responses as such remarks appear to be out of the scope of the Working Group’s statutory duties.
Public Comments
Leigh Ann introduced the public comment session. She briefly explained the process for providing verbal comments at the meeting and the time allocated for each commenter (3 minutes). She reminded the public of the three ways to provide comments (providing oral comments at the Working Group’s public meetings, sending written comments by email to [email protected], or submitting comments online through the Working Group’s website: https://www.hhs.gov/ash/advisory-committees/tickbornedisease/contact-us/index.html).
Ten members of the public provided comments over the phone.
Julia Wagner: Julia stated that she is the president of PA Lyme Resource Network, and that she would focus her comments on the Working Group’s draft report and the proposed actions of four subcommittees. Julia pointed out that the research agenda described by the Working Group is missing a focus on three critical topics, including 1) multi-pathogen diseases, 2) immune dysfunction in tick-borne diseases, and 3) inflammation and neurological manifestation of tick-borne diseases. She commented that improved understanding in these areas would help identify better therapeutic targets.
Julia commented that the Working Group’s overall recommendations focus heavily on longer-term strategies; however, she emphasized, it is imperative that these recommendations also deliver immediate improvement to patient care, particularly therapeutic options. Julia also asked the Working Group to update Chapter 7 of the Working Group’s Report to Congress to reflect that all eight insurers have settled a case against the Infectious Diseases Society of America (IDSA) and the insurers. She asked the Federal agencies to take immediate actions to ensure their websites and other materials accurately reflect the broad spectrum of treatment options available without bias, stress the need for individualized treatment options, and inform the insurers of the shift to address the structural barrier and improve access to affordable care that restores health.
Lucy Barnes: Lucy criticized the government for not adequately addressing the need for accurate diagnostic tests, reporting systems, effective treatment options, prevention programs, and insurance coverage. Lucy stated that the treatment guidelines—which she described as approved by the government—are responsible for people developing chronic illness and disability, and causing death. She criticized that many members of the Working Group have never treated patients with chronic Lyme disease and, therefore, are not able to provide personal insight. She expressed her opinion that the content of the Working Group’s report does not reflect patients’ input and concerns, and that patients with tick-borne diseases have not been well represented. Lucy suggested that the 2020 Working Group Report to Congress be rejected and new members be put in place to develop a new report.
Kristina Bauer: Kristina stated that she is the Director of Texas Lyme Alliance and a board member of Mothers Against Lyme. Kristina stated that the Tick-Borne Disease Working Group was established to help patients, and that the voting records, however, indicate that not all Federal members are representing the interest of the patients, particularly those with persistent Lyme disease. She criticized individual members of the Working Group for not recognizing persistent Lyme disease, and the Working Group for allowing proxy votes. She stated that the U.S. government recognizes chronic Lyme disease as a protected pre-existing condition, and that the Affordable Care Act in 2012 accepted Lyme disease as a chronic illness in unrestricted treatment. She also commented that there are 15 Lyme codes in ICD-11, which have been formally accepted by the World Health Organization and 194 nations, and she criticized the Working Group members for denying the science behind those codes. Kristina asked the Working Group to take actions to stop the disease and prevent the suffering on a massive scale in the United States.
Amy LeBoeuf: Amy focused her comment on prevention of tick-borne diseases. Amy described her son’s sudden illness and worsening symptoms. She shared their journal of seeking diagnosis and treatment over the course of two years, during which they saw 40 doctors across 19 specialties, none of whom asked about exposures to animals or insects. Amy shared that right before her son became suddenly ill, he was scratched by a stray cat and they found a tick on his bed, carried inside by their dog. She shared that her son was finally diagnosed with bartonellosis and effectively treated by a physician scientist who embraces the One Health approach. Amy explained that after three and a half years of treatment, her son has almost fully regained his health. Amy, an educator, pointed out that other students like her son are at risk of contracting tick-borne diseases. She commented that students and teachers should receive education on vector-borne diseases and how to protect themselves. She encouraged the Working Group to recommend that the One Health approach be incorporated into the National Health Education Standards to teach children about zoonotic and vector-borne diseases and to prevent tick-borne diseases.
Lorraine Johnson: Lorraine stated that she is the CEO of LymeDisease.org, and she focused her comment on transparency and fairness regarding how HHS selects Tick-Borne Disease Working Group public members. She commented that the selection of public members for the 2019-2020 Working Group members lacked transparency; the public was not informed about the selection criteria and each member’ representation; and tick-borne disease patients were not well represented. She commented that for the next term, 1) the Working Group should include three patient advocates recognized by the patient community, 2) all Working Group members’ terms should expire on the same date, and 3) HHS should publicly announce the full slate of Working Group member and specify the legislative role that each member fills.
Jennifer Platt: Jennifer congratulated the Working Group on the completion of the report, encouraged HHS to further clarify membership expectations, and suggested that the next Working Group encompass a wider range of representation from patients with tick-borne diseases and/or conditions such as Alpha-gal Syndrome. She suggested that collaborative and inclusive efforts are required to address the complexities of tick-borne diseases and conditions. Jennifer noted that similar to patients with Lyme disease, patients with other tick-borne diseases and conditions also suffer chronic symptoms. Jennifer noted that the diseases many patients have do not match up with the ticks that bite them, highlighting this as a gap in knowledge. As HHS is preparing to select new Working Group members, she asked everyone to inquire: What and who are we missing?
Janice Sutton: Janice stated that she is a registered nurse whose daughter has been fighting bartonellosis and medical neglect for seven years. Janice commented that many patients have had experiences similar to her daughter’s, and she shared stories of multiple people whose lives have been affected by tick-borne diseases and who have been harmed by medical neglect. She highlighted a recent prediction that more than two million people in the U.S. could suffer profound disability from post-treatment Lyme disease syndrome by the end of this year. She referenced a recent settlement in a lawsuit and commented on culpability.
Betty Gordon: Betty from Iowa expressed her disappointment in the viewpoints of the Federal representatives and criticized the authors of the minority responses in Chapter 7 of the Working Group’s report. She commented that patients were not well represented by this Working Group and requested that the next Tick-Borne Disease Working Group include four patient representatives, including one International Lyme and Associated Diseases Society (ILADS) treating doctor. Betty then shared that her husband died from two tick-borne diseases (Lyme disease and Bartonellosis, as revealed by brain autopsies) but was not never diagnosed before he died. She also shared that she was not able to have her husband’s death certificate amended, and her husband’s case was not added to her Iowa state Lyme statistics. She asked that the next Working Group request public commenters to write short double-spaced paragraphs, so that neurocognitive patients like her (misdiagnosed for many years, she added) could read and comprehend their comments.
Holly Ahern: Holly highlighted the need for unbiased evaluation of all available science related to Lyme disease. She commented that the focus of the Tick-Borne Disease Working Group should have been on Lyme disease, which represents the majority of tick-borne disease cases in the U.S., adding that many patients with Lyme disease develop long-term illness. She commented on treatment guidelines and pointed out that, currently, no diagnostic tool can adequately discern people who are actively infected with B. burgdorferi from those who are not, and that high-quality studies cannot be designed without accurate diagnostic tools. She said that it is discrimination to deny patients access to health care based on results of blood tests known to be inaccurate, on poorly designed clinical studies, and on decades-old medical biases is discrimination. She stated that better science is available and it is time to move on.
Mira Shapiro: Mira stated that she is a chronic Lyme disease patient, a biostatistician, and a data scientist who works with Lymedisease.org. Mira commented on Lyme disease research and how the community needs to work together to move research forward to better understand, test for, and treat Lyme disease from acute to chronic forms. Mira highlighted the many types of data that can be used for health research, including results of clinical trials, patient charts, medical records, patient registries (for example, MyLymeData), specialized surveys, as well as serum and tissue banks, autopsy reports, and social media content. She pointed out that all data types have strengths and weaknesses, and that different types of evidence should be viewed as complementary rather than competing. Mira suggested using advanced technology to harness the data from various sources, which could then be used to create useful information, guide research design, better understand patients while protecting the patients’ privacy. Mira commented that greater volumes of data would help improve disease identification and the development of patient-centered care and treatments. Mira expressed her hope that the new Tick-Borne Disease Working Group would encourage and assist the medical and health care research community to leverage the wealth of available data to focus on patient-centered research and solutions.
LymeX Presentation
David introduced Kristen Honey, PhD, PMP, Senior Advisor to the Assistant Secretary for Health, Chief Data Scientist, HHS, who gave a presentation on the HHS Lyme Innovation initiative and LymeX Partnership.
Lyme Innovation Initiative
Kristen stated that HHS is striving to solve Lyme disease-related issues from multiple angles, and her office (Office of Chief Technology Officer) is aiming to turn the Tick-Borne Disease Working Group’s recommendations into actions. She shared that in 2018, HHS launched the Lyme Innovation initiative, which uses collaboration, data-driven innovation, emerging technologies, and strategic partnerships to accelerate advancements in Lyme disease and other tick-borne diseases. She noted that the initiative was built upon the community’s years of collaborative efforts.
LymeX Innovation Accelerator
Kristen explained that the efforts led to the $25-million LymeX Innovation Accelerator (https://www.hhs.gov/cto/initiatives/innovation-and-partnerships/lyme-innovation/lymex/index.html), which was publicly announced in October 2020. The project, she added, is a collaboration between HHS and the Steven & Alexandra Cohen Foundation, and is the largest Lyme disease public-private partnership in history. She clarified that the plan is to get started with Lyme Innovation in smaller-scale events, such as roundtables and listening sessions.
Kristen further explained that in 2019, the Kay Hagen Tick Act authorized $30 million per year for five years for vector-borne diseases. She clarified that the funding has been authorized/approved but not appropriated by Congress. To move things forward, she continued, HHS has decided to leverage resources from other sectors. She highlighted that LymeX was modeled after the KidneyX Innovation Accelerator (https://www.kidneyx.org), a public-private partnership between HHS and the American Society of Nephrology that unlocked tremendous resources.
Kristen outlined the three main components of LymeX:
- Patient-centered Innovations (Health+)
- Education and Awareness
- Next-Gen Diagnostics
Regarding the first bullet above, Kristen explained that Health+ is a framework and ongoing series of HHS research and problem-solving cycles focused on specific, high-impact health issues. She noted that each Health+ cycle progresses through four phases: Intake & Communications; Design & Discovery; Definition; and Prototyping. Kristen noted that learning from the patients’ experiences and doing the work around patients is the pillar of Health+.
Kristen underscored the general consensus about the need for enhanced education and heightened awareness about tick-borne diseases. She added that LymeX is organizing a series of events to address this need and supports innovative health education and public awareness initiatives using unconventional approaches such as crowd sourcing, citizen science, and prize challenges.
Kristen highlighted the many emerging (next-generation) diagnostic technologies, stressing that the faster they can move through the regulatory process and meet the FDA standards, the more impactful they can be. She clarified that LymeX does not provide grants but rather prize challenges. She further explained that LymeX does not supersede other Federal programs focusing on Lyme disease; it is another way to tackle the multi-faceted challenge.
Kristen described how the community, including patients and caregivers, can get involved through Health+ (https://www.hhs.gov/cto/initiatives/digital-services/health-plus/index.html). She explained that HHS has hired a third-party neutral contractor/organization, which visits communities and conducts interviews. She encouraged people to visit https://lymex.crowdicity.com to share experiences and sign up to be interviewed.
Kristen explained that under ADM Brett Giroir’s leadership, HHS
- Is revising and updating its internal memorandum of understanding (MOU) to define/clarify roles and responsibilities of different offices within the department; and
- Has drafted a Federal Register Notice soliciting information regarding Lyme disease diagnostics to better understand the full ecosystem.
Regarding timeline, Kristen shared that the first-prize challenge is expected to be announced in the second quarter of 2021 and, at the outset, will most likely focus on education and prevention. However, she noted, stakeholder engagement and Health+ efforts have already begun.
Following Kristen’s presentation, Working Group member Pat Smith, President, Lyme Disease Association, Inc., asked how much control the government has over LymeX funding and how it would be distributed.
Kristen responded that LymeX is following the KidneyX Innovation Accelerator model, and will create a new entity (LymeX.org), which does not represent the government nor Steven & Alexandra Cohen Foundation. She added that the initiative will be overseen by a steering committee (to be approved by both HHS and the Steven & Alexandra Cohen Foundation), which will be the final approver of what to focus on and how and where to spend the money, and determine the winner of the challenges. She explained that there will be stakeholders/experts providing input to the steering committee, including internal government subject matter experts and a formal scientific advisory board with external people; however, the financial decisions will be determined by the LymeX steering committee.
Tick-Borne Disease Working Group Report Review
The Working Group reviewed all chapters in the final report format. Jennifer Gillissen, Kauffman and Associates, Inc., explained all of the changes that had been made since the previous meeting, at which, she noted, all chapters were approved.
Executive Summary
Jennifer reviewed and explained each of the changes made based on the Working Group’s discussion during the November meeting.
There were no questions or comments from the Working Group.
Chapter 1: Background
Jennifer explained that a small section of the chapter was reformatted (that is, three short paragraphs were combined into one single paragraph).
There were no questions or comments from the Working Group.
Chapter 2: Methods
Jennifer explained that the following sentence pertaining to minority responses was added based on the HHS Office of General Council:
“Minority responses reflect the views of the individual authors and do not necessarily reflect the views of the Working Group or the U.S. Department of Health and Human Services.”
Working Group members generally agreed to the addition.
Chapter 3: Tick Biology, Ecology, and Control
Jennifer explained the editorial changes made based on the Working Group’s input.
There were no questions or comments from the Working Group.
Chapter 4: Clinical Manifestations, Diagnosis, and Diagnostics
Jennifer explained the editorial changes. She noted that one reference was removed based on the Working Group’s input, and that “Minority Report” would be changed to “Minority Response” for consistency throughout the report.
David suggested replacing “healthy patients” with “healthy persons” in one sentence on page 32 of the report. Sam Donta, MD, Professor of Medicine (retired); Consultant, Infectious Disease; writing co-lead of Chapter 4 agreed.
The Working Group then discussed if authors of the minority responses should be kept confidential. Different viewpoints were expressed. While some members suggested following previous report procedure, whereby minority responses were not signed by the author(s), others noted that the minority responses should be attributed to the individuals who wrote them.
The Working Group asked the DFO to provide guidance because it is a rule-related issue. Kaye Hayes, MPA, Alternate DFO, explained that based on the Federal Advisory Committee Act (FACA) rule, activities required to be conducted in the public domain should be transparent.
After Kaye provided the guidance, Eugene (Gene) Shapiro, MD, Professor of Pediatrics, Epidemiology, and Investigative Medicine, Yale University School of Medicine; Vice Chair for Research, Department of Pediatrics; Co-Director of Education, Yale Center for Clinical Investigation; Deputy Director, Yale PhD Program in Investigative Medicine, stated that he wrote the minority response in Chapter 4.
Motion and Vote
Sam made a motion to add the author(s) of minority responses at the end of the responses.
Leigh Ann stated that the Working Group should establish a procedure to standardize all the minority responses.
Prompted by a question from David, Jennifer explained that authors of the minority responses did not appear in the 2018 Tick-Borne Disease Working Group Report to Congress.
Jim stated that it is up to the Working Group to decide how they want to handle the issue.
Sam reiterated his motion.
Pat seconded the motion.
The group further discussed if the names of the agencies should be included along with the names of three agencies’ representatives who co-wrote the minority response in Chapter 7. Sam reiterated that his motion was to add the individuals’ names; he explained that it is understood that the Federal members of the Working Group represent their individual agencies.
Vote
Working Group members unanimously voted yes to add author names at the end of minority responses. The motion passed.
Jennifer stated that based on the motion, Gene’s name will be added to the Chapter 4 minority response.
David asked to add his name to the minority response in Chapter 4 because he agrees with it.
Other members pointed out that David’s name cannot be added to this minority response because David did not vote against the chapter and did not write the minority response.
Chapter 5: Causes, Pathogenesis, and Pathophysiology
Jennifer explained that this chapter was approved with no additional changes.
Chapter 6: Treatment
Jennifer explained that one reference was removed based on the Working Group’s discussion during the November meeting.
There were no questions or comments from the Working Group.
Chapter 7: Clinician and Public Education, Patient Access to Care
Jennifer noted that Chapter 7 was approved with editorial changes, and she went through the changes made based on the Working Group’s discussion during the November meeting. She stated that based on the motions just passed, names of the minority response authors will be added, as follows:
Minority Response 1: Charles Benjamin (Ben) Beard, PhD; Dennis M. Dixon, PhD; CDR Todd Myers, PhD, HCLD (ABB), MB (ASCP)
Minority Response 2: Eugene David Shapiro, MD; David Hughes Walker, MD
Minority Response 3: Kevin Macaluso, PhD
Chapter 8: Epidemiology and Surveillance
Jennifer stated that Chapter 8 was approved with editorial changes. She explained that an image had been replaced with a table in order to meet 508 compliance standards, and that the information remains the same.
Pat pointed out that one sentence on page 87 was in the wrong place and suggested moving it to the end of the paragraph to improve flow.
Ben agreed.
Jennifer stated that her team would make the changes and would also add Pat’s name to the minority response.
Chapter 9: Federal Inventory
Jennifer explained that Chapter 9 was approved with no editorial changes. She pointed out that Recommendation 9.3 will require a minor change (that is, reformatting the word if from uppercase to bold) for 508 compliance.
Working Group members generally agreed to the change.
Jennifer explained that the following sentence had been updated based on the DFO’s input.
“The complete inventory survey results can be obtained by any individual who submits a request through the Tick-Borne Disease Working Group emailbox: [email protected].”
Working Group members did not have questions or comments about the change.
Chapter 10: Public Input
Jennifer explained that the image included in Chapter 10 had been moved to the beginning of the chapter based on the Working Group’s suggestion. She asked if Working Group members had questions regarding the placement of the graphic.
Working Group members were fine with the placement.
Chapter 11: Looking Forward
Jennifer explained that Chapter 11 was approved with no changes during the November meeting. She stated that names of the minority response authors would be added (Pat Smith and CAPT Scott J. Cooper), and a link within one of the minority response references would be corrected.
Conclusion
Jennifer explained that the report Conclusion was approved without any changes.
Adalberto (Beto) Pérez de León, DVM, MS, PhD, Director, San Joaquin Valley Agricultural Science Center, U.S. Department of Agriculture–Agriculture Services, asked if the report needs to include today’s presentation on LymeX.
David explained that the presentation was just for information, and it is not part of the report.
Appendices
Appendices A and B
Jennifer explained that Working Group members’ credentials in Appendix A and Subcommittee members’ credentials in Appendix B had been updated for consistency.
Jennifer noted that public member categories had been added in Appendix A.
Pat asked to add “family member” to her category.
Jim responded that he had replied to Pat’s email request and concurred with the request.
Jennifer stated that her team would add “family member” to Pat’s public member category.
Appendices C-D
Jennifer continued to explain that acronyms and abbreviations in Appendix C had been verified, Appendix D (21st Century Cures Act) remains the same, and Appendix E (Working Group Charter) had been updated to reflect the current charter and the new approval date.
Sam asked to clarify the ending date of the Working Group’s Charter.
Jim explained that the Charter for any advisory committee has to be reviewed, updated, and approved by the HHS secretary every two years.
Jennifer explained that the word “Survey” had been added to the title of Appendix F (Federal Inventory) and the rest of the appendix remains the same.
Appendix G
Jennifer noted that Appendix G (References) contains all of the references cited in the report chapters, and that the references had been updated based on the Working Group’s discussion.
There were no further questions about the Appendices.
Front Cover, Table of Contents, and Back Cover Review
Jennifer showed the graphics on the front and back covers of the report and explained that the graphics on the front cover had been updated.
Pat stated that all the graphics look good, and she expressed gratitude for the team’s support.
Jennifer then explained the changes made to the Table of Contents.
David asked to correct Beto’s name.
Vote to Approved the Final Report
Sam made a motion to approve the whole report.
Pat seconded the motion.
Working Group members (14) unanimously voted yes to approve the report. The motion was passed.
Working Group Members’ Closing Comments
Leigh Ann announced that, if desired, each member would have two to three minutes to provide final comments. Members of the Working Group, one by one, shared final thoughts and provided brief comment.
Beto thanked all members for the collaborative work and stated that he hopes the report will benefit the public.
Angel echoed Beto’s comment. She thanked Scott and Leigh Ann for co-leading the Alpha-gal Syndrome Subcommittee and thanked other members of the subcommittee for their contributions. She also thanked all of the patients and advocates for providing input.
Ben expressed special thanks to non-Federal members of the Working Group for their hard work and time. He also recognized the subcommittee members for their hard work and for putting together great subcommittee reports. He thanked the patients and advocacy group members for submitting public comments. He explained that he shared their comments with colleagues at his agency who appreciate their input. Ben also thanked everyone for working together to produce an important report that will have an impact.
Dennis expressed appreciation for the opportunity to serve on the Working Group and for member’s efforts, which have demonstrated some valuable points including: 1) the value of considering different viewpoints when addressing difficult and controversial topics, 2) the value of coming together to strive for working on a consensus report, and 3) the value of letting everyone’s voice be heard through minority responses when consensus cannot be reached on particular topics.
Gene thanked everyone for their hard work, particularly the Co-Chairs of the Working Group and Jennifer’s team.
Kevin echoed everyone’s comments and thanked members of the Tick Biology, Ecology, and Control Subcommittee for their work.
Leith expressed his pleasure of working with everyone and his appreciation for the opportunity to learn and to apply the lessons learned to other disease areas. He stated that to him, one of the great lessons learned is: Just because we do not agree does not mean that we cannot make progress. He felt that everyone has been heard during the process of developing the 2020 Report to Congress. He noted that the Working Group’s activities and output represent part of the collective efforts across HHS and private sectors to implement the national strategy. He expressed his hope that the Working Group’s report can serve as a sounding board for continued changes. He thanked everyone and especially the patients for providing input.
Pat first thanked the first Tick-Borne Disease Working Group for their 2018 Report to Congress. She also thanked this year’s subcommittees for their hard work, the public for their comments, the HHS staff, and members of the current Working Group for supporting the patients who are suffering from chronic diseases. She especially thanked Coop for his tireless work. Pat expressed her view that the report would do little to help the patients. She commented that transparency was lacking around Working Group member selection, and she criticized the Working Group’s proxy votes. She expressed her opinion that Lyme disease patients’ input, in her opinion, was scrutinized. Pat also commented on the voting of Chapter 7, and she stated that the decisions of the Federal members do not reflect the patients’ voices. She said that other diseases are treated more seriously than Lyme disease. She thanked members of the current Working Group members for their work. She ended with a quote from Isaac Asimov: “Your assumptions are your windows on the world. Scrub them off every once in a while, or the light won't come in.”
Sam appreciated the opportunity to share his knowledge and experience gained from research and by taking care of patients. He thanked the subcommittee members for their contributions and stated that the Working Group’s Report to Congress contains important information. He expressed hope that HHS and Congress could move quickly to solve some of the issues around Lyme disease.
Scott Commins expressed appreciation for the opportunity to serve patients, especially those with Alpha-gal Syndrome. He stated that he would be pleased to serve on the Working Group again if selected. He noted that he has learned a lot through the subcommittees’ work, particularly from the patients while serving on the Public Comments Subcommittee. He stated that in his view, the Working Group has done a lot of work and has moved things forward; however, much remains to be done, particularly in areas where there is uncertainty that directly affects patients and patient care. In his opinion, the science does not reflect what the patient is reporting, and he noted that better science is needed. He emphasized that patients’ complaints or symptoms should not be minimized. He stated that the National Institute of Allergy and Infectious Diseases (NIAID) should be empowered to create a consensus committee to direct funds toward addressing unmet needs and unanswered questions outside a section review. Scott thanked patients and subcommittee members for their input and contributions.
Coop stated that he was a member of the first Working Group (2017-2018), and is an alternate member for this group (2019-2020). He thanked Pat for working together with him on developing Chapter 7, HHS and Jennifer’s team for their support, CMS leadership for letting him be part of this Working Group, as well as the public and the patients for their input. He reminded everyone to recall the Working Group’s Mission, Vision, and Core Values, which he helped draft.
Todd thanked David Walker, with whom he co-chaired the Rickettsiosis Subcommittee, for his knowledge and leadership in producing the subcommittee report. He also thanked Sam for taking a lead in putting together Chapter 4 of the report. He stated that he was glad to see that the final Working Group report encompasses other tick-borne diseases as many patients (for example, Rickettsiosis Subcommittee member Tony Galbo who lost his daughter due to Rocky Mountain spotted fever) have lost family members. He noted that even though not everyone agrees on certain definitions of tick-borne illnesses, the disagreement highlights the importance of these diseases. He expressed his hope that Congress would provide resources to develop diagnostic tools, treatment strategies, and a vaccine, which, in his view, is important. He thanked everyone for their work.
Leigh Ann thanked Jim, Kaye, Jennifer and her team, David, all Working Group members, and all subcommittee members for their hard work, dedication, and care for the patient. She also thanked the 2018 Working Group for laying the groundwork. She stated that the report is not the end, and that it is moving the overall initiative in the right direction.
David reflected on the inaugural meeting of this Working Group. He noted that his intention was for the Working Group to address not only Lyme disease but also other tick-borne diseases and conditions. He stated that if HHS and Congress support the Working Group’s recommendations, the Working Group would have achieved numerous beneficial public health goals. David thanked everyone for working with him, particularly Leigh Ann for co-chairing the Working Group with him.
Closing Remark and Adjournment
Jim thanked all of the Working Group members for their contributions, as well as the Office of Infectious Disease Prevention team and the Kauffman & Associates team for their support. He stated that the final report will be submitted to Congress.
Jim adjourned the meeting at 11:34 am.
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; 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 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
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, 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 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: 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
