TBDWG June 4, 2019 - Meeting Summary
Welcome & Leadership Remarks - Membership Introductions
Overview of Working Group Mission, Vision, & Values
2018 Report to Congress Milestones & Actions
Review of Working Group Charter, Roles/Responsibilities, &Voting
2020 Working Group Objectives - Timeline for Report To Congress
NIH and CDC Updates
Public Comment Subcommittee
Discussion of Potential Subcommittees
Discussion of Topic Development Briefs
Closing Remarks and Next Meeting
Appendix: TBDWG Members and HHS Staff
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.
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; Working Group Co-Chair, welcomed participants to the meeting and conducted roll call (see Appendix: Working Group Co-Chairs, Members, and Designated Federal Officers). The meeting started with a quorum.
David and Co-Chair Leigh Ann Soltysiak, MS, Owner, Principal, Silverleaf Consulting, LLC; Adjunct Professor, Stevens Institute of Technology,Entrepreneurship Thinking, introduced themselves and described their backgrounds as they relate to tick-borne disease.
James (Jim) Berger, MS, MT (ASCP), SBB, Senior Blood and Tissue Policy Advisor, Office of HIV/AIDS and Infectious Disease Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services (HHS); Designated Federal Officer (DFO), then introduced Rear Admiral (RADM) Sylvia Trent-Adams, PhD, RN, FAAN, Principal Deputy Assistant Secretary for Health, who welcomed and thanked the 2020 Tick-Borne Disease Working Group members for committing their time and knowledge to the issue of tick-borne diseases. She expressed her eagerness to see how the 2020 members would continue the legacy set by the 2018 Working Group and asked them to work through their challenges and disagreements with an open mind as they fulfill their charge. She also stressed the importance of maintaining openness and transparency to the public throughout their tenure.
Swearing in of Members
RADM Trent-Adams invited the 2020 Working Group members to the front of the room where they were sworn in.
All members who were present introduced themselves, as did Jim and Alternate DFO Kaye Hayes, MPA, Deputy Director, Office of HIV/AIDS and Infectious Disease Policy, Office of the Assistant Secretary for Health, HHS. Leigh Ann noted that alternate Working Group members are part of the Committee. She explained that some of the alternate members are not present at today’s meeting but may attend other meetings in the future.
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, and 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 the future.
Next, Jim read aloud 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.
Finally, Jim gave an overview of the Working Group’s Core Values, the complete versions of which are provided below.
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 & 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.
Leigh Ann reviewed the following milestones and actions that resulted in the 2018 Report to Congress.
February 12, 2018: The Working Group subcommittees were created.
May 10, 2018: The subcommittee reports were submitted to the Working Group.
June 21, 2018: Writing began for the Report to Congress.
November 14, 2018: The Report to Congress was submitted to the Assistant Secretary of Health and to Congress. The report was made accessible to the public on the Working Group website.
December 8, 2018: The final 2018 Working Group meeting took place.
January 2019: The Centers for Disease Control (CDC) released its National Strategy for Vector-Borne Disease Prevention and Control and the National Institutes of Health (NIH) released its request for information (RFI).
Jim provided a high-level overview of the Working Group’s Charter, which can be viewed in its entirety at the following link.
He then explained the roles and responsibilities starting with the co-chairs, who are responsible for:
- Developing meeting agendas;
- Convening and adjourning meetings;
- Conducting meetings following the Robert’s Rules of Order;
- Approving minutes for the meetings they convene;
- Planning the work of the committee; and
- Working with the DFO and alternate DFO to ensure alignment with the Working Group Charter and Federal Advisory Committee Act (FACA) regulations, and to provide support to the committee.
Jim added that, as DFO and alternate DFO, his and Kaye’s role is to:
- Ensure compliance with the FACA and any other laws and regulations (described below);
- Approve agendas provided by the Working Group;
- Call to order, attend, and adjourn Working Group meetings;
- Ensure efficient operations; and
- Maintain required records which, once approved by the Working Group Co-chairs, are placed on the Working Group website [https://www.hhs.gov/ash/advisory-committees/tickbornedisease/index.html]
Jim clarified that FACA-governed groups cannot meet without a DFO or designate present at the meeting.
Next, Jim reviewed the FACA requirements that govern the Working Group’s activities. According to the Act, meetings must be open to the public except where a closed or partially closed meeting has been determined proper and consistent with the exemptions of the Government in the Sunshine Act, 5 U.S.C. 552b(c). Public notice of meetings must be published in the Federal Register at least 15 days in advance of the meeting. Any member of the public is permitted to file a written statement with the advisory committee and may speak to or otherwise address the advisory committee if the agency’s guidelines so permit (for example, as a verbal comment during public meetings). Recommendations must be “objective and accessible to the public.” Finally, subcommittees must report and make recommendations to the advisory committee; and the recommendations must be fully discussed and deliberated by the advisory committee before adopting.
One Working Group member requested that the meeting minutes and recordings be made available to the Working Group to help inform the group’s decisions and activities, and that the Working Group members have the opportunity to comment on agendas for future meetings.
David outlined the objectives for the 2020 Report to Congress, as described in the Working Group’s Charter. According to the Charter, he explained, the Working Group is charged with updating a summary of the causes, prevention, treatment, diagnosis, diagnostics, duration of illness, and intervention of tick-borne diseases. The group must also determine what advances have been made as a result of the research conducted on tick-borne diseases. The Working Group must make an inventory of Federal activities conducted in response to tick-borne diseases and assess the basic clinical and translational research. Perhaps most importantly, David added, the Working Group must identify gaps in tick-borne disease research and make recommendations to Congress to set aside money to conduct research that fills those gaps.
David then explained his position on how the Working Group could fulfill its charge, noting that other members may have different ideas. He stated that he envisioned performing an update on Lyme disease and an expanded discussion of other tick-borne diseases, not just as coinfections with Lyme disease, but as primary infections. One Working Group member expressed the view that, given the significant societal burden, chronic Lyme disease should be a major focus of the 2020 Working Group report.
Meeting 9 Objectives: What We Hope to Accomplish Today
Leigh Ann explained that the first objective of meeting 9 is to engage stakeholders through the live stream and to hear public comments. A second objective, she noted, is to establish subcommittees, which would conduct the bulk of the work in preparation for writing the 2020 Report to Congress. The third objective, she added, is to discuss topic development briefs, for which the Working Group received funding to produce.
Timeline for the 2020 Report to Congress
Leigh Ann then presented a timeline for producing the 2020 Report to Congress. She stated that the report would be submitted in November of 2020. It will be informed by subcommittee reports, which will have their own set of milestones and deadlines. The Working Group then discussed how best to conduct the work laid out before them with the time they have remaining. It was generally agreed that the timeline is reasonable.
David suggested the subcommittees conduct weekly or biweekly teleconferences, on which the Working Group members generally agreed. He added that the subcommittee reports will need to be completed by January, 2020, and the final Report to Congress by July, 2020.
There was a general agreement that the 2020 Working Group should learn from the challenges experienced by the 2018 subcommittees. Members who had participated in the 2018 process explained that producing the subcommittee reports required tremendous effort, and several subcommittee reports contained significantly more information than could be used in the 2018 Report to Congress. Members stressed the importance of clearly outlining the process at the outset and streamlining it as much as possible. They emphasized the need to minimize overlap between subcommittee reports.
Members asked questions about how the subcommittee process works. Jim explained that subcommittee co-chairs are responsible for orchestrating the entire process and ensuring that timelines are met. He added that the subcommittee process is supported by a contractor who attends subcommittee meetings, records minutes, and writes summaries, which are then provided to the co-chairs for review. Ultimately, he noted, the full Working Group reviews content from the subcommittees and votes on what to include in their Report to Congress. To this statement, one member added that it will be important to clarify to anyone participating in the subcommittee process that the subcommittee reports inform, but do not comprise, the final Report to Congress.
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, provided an overview of the NIH Tick-Borne Disease RFI, which is the first step in developing the NIH Strategic Plan requested by the 2018 Working Group. The RFI was a formal solicitation of feedback from the public. It resulted in about 100 responses from researchers, health care providers, and patients, with a range of recommendations related to research gaps, educational needs, procedural changes, among other things. Sam added that the feedback would be incorporated into the NIH Strategic Plan expected in the fall of 2019. A summary of the RFI, he noted, would be included in the Strategic Plan; however, individual comments would not be provided due in part to privacy restrictions.
Sam also discussed an NIH program announcement initiated about two years ago for general research on tick-borne diseases and a more recent request for applications on targeted tick-borne diseases prevention. He estimated that the NIH would be funding some awards by the summer of 2020.
CDC National Strategy for Vector-Borne Disease Prevention and Control
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, provided an overview of the CDC National Strategy for Vector-Borne Disease Prevention and Control. The Strategy, he explained, was initiated in response to the Zika outbreak, the three-fold increase in reported vector-borne diseases, and the nine new pathogens spread by mosquitos and ticks, pathogens not previously seen in the United States.
Ben described the process for developing the Strategy report, which includes input from six Federal departments and 12 Federal agencies. He stated that the document, which is currently in the clearance process, contains a mission statement, a vision statement, and six goals with strategies and sub-strategies for meeting them. He added that, once the document is cleared, the objective will be to develop action plans with milestones that can be measured. A summary of the Strategy report, he concluded, was published in the May 2018 Mortality and Morbidity Report [https://www.cdc.gov/mmwr/volumes/67/wr/mm6717e1.htm].
In response to a question from one of the members, Ben clarified that CDC would also seek input from the Council of State and Territorial Epidemiologists for the National Strategy report. Additionally, he noted, the report would address the limitations of surveillance and the misuse of surveillance data for clinical purposes.
Robert (Bob) Sabatino, Founder and Executive Director, Lyme Society Inc., provided an overview of the membership and activities of the Working Group’s Public Comment Subcommittee, formed at the 2018 Tick-Borne Disease Working Group Meeting 7 on July 24, 2018. The group, he stated, meets every 3rd Wednesday to review and discuss the written comments submitted to the Working Group’s email address [email@example.com]. At the time of Meeting 9, the subcommittee had received and read nearly 1000 written comments.
Bob offered a high-level summary of the views expressed by public commenters. The primary concern, he stated, is that Lyme disease and other tick-borne diseases are not being sufficiently addressed by mainstream medicine and government programs today. The public asked for the Working Group to:
Recommend increased funding for the scientific exploration and unbiased review of the latest information from across all disciplines and sectors;
- Voluntarily disclose conflicts of interest;
- Make the Federal inventory available to the public;
- Improve communications, email responsiveness, and website timeliness;
- Give the public more time to review draft material before Working Group meetings;
- Evaluate the role of tick-borne diseases in other chronic illnesses with unknown etiologies; and
- Support new thinking, new collaborations, and public private partnerships.
Bob noted that since the 2018 Report to Congress, the tone of the public comments has become more positive. He stated that medical practitioners, patients, students, and researchers want to be part of the solution, and many expressed interests in volunteering or joining the Working Group.
Following Working Group members’ suggestion, Leigh Ann noted that public comments should be sent to the Working Group’s official email address [firstname.lastname@example.org], not Working Group members’ personal emails.
Jim added that his office generally acknowledges the receipt of emails sent to the official address within a couple of days, and the intention is to respond to all emails in a timely fashion.
Eight members of the public provided comments to the Working Group.
Kristina Bauer: Kristina noted that she has provided comments to the Working Group before and has tried to contact Congress for a public hearing. She shared her view about the charter, and the public’s desire for enhanced transparency. She also expressed concern about the Working Group’s recommendation to develop a vaccine, which she feels would not be able to keep up with mutations of the pathogen. She urged the Working Group instead to focus on helping those who are already sick. She explained that her four children have Lyme disease, and that she, herself, has suffered from chronic Lyme disease since the age of four. She expressed her opinion about the Infectious Disease Society of America guidelines for treating Lyme disease, which she stated, obstruct chronically ill patients from receiving health insurance coverage. She also expressed concern about conflicts of interest of members of the Working Group.
Jennifer Platt: Jennifer, co-founder of Tick-Borne Conditions United, thanked the Working Group for acknowledging the lesser-known tick-borne conditions, including rickettsial and ehrlichial infections. She urged the Working Group to focus more on diseases and conditions transmitted by the lone star tick, which is expanding its range. She added that, in her county, over 90% of the population has been exposed to ticks.
Jennifer thanked the CDC for adding alpha-gal allergy to its website. However, she asked for the following clarifications.
- List the lone star tick as a vector of Rocky Mountain spotted fever (RMSF) in the new training module provided on the website.
- Update the website to say that the alpha-gal carbohydrate has been isolated not only in the saliva of the lone star tick, but in the black-legged tick as well.
She concluded by stating that much more research is needed to understand the alpha-gal allergy, as well as its transmission and treatment.
Kristina Bauer, on behalf of Michael Bauer: Kristina urged the Working Group to acknowledge and address persistent Lyme disease. She stated that, despite the availability of over 700 peer-reviewed articles related to persistence, there is little discussion about it. She added that the Working Group should promote the International Lyme and Associated Diseases Society guidelines for treating tick-borne diseases because they support the use of integrative medicine. She stated that integrative medicine (for example herbal medicine) is supported by literature (for example, Zhang and colleague’s publication) and is what works for her family, although they cannot get insurance coverage for it.
Mira Shapiro: Mira provided comment as a representative of LymeDisease.org. She expressed her dissatisfaction with the selection process of the Working Group members, and voiced concern about lack of transparency and conflicts of interest. She identified specific members she did not support and provided her reasoning. She urged the Working Group to focus on Lyme disease because, she clarified, it represents the greatest burden of tick-borne disease.
Melissa Potter: Melissa stated that she is the director of patient engagement and outreach for LymeDisease.org, and that her comments reflect the results of two large-scale surveys conducted by her organization, which represents thousands of chronic Lyme disease patients. She stressed that the Working Group should include at least three public members representing patients with chronic Lyme disease. These members, she added, should have lived experience with chronic Lyme disease as either a patient or caregiver and be knowledgeable about the issues specific to the community, including scientific challenges and barriers to access to care. She noted that LymeDisease.org recommended several potential patient representatives for the Working Group; however, her organization was never contacted about those individuals.
In addition to the above public members who registered online prior to the meeting to provide comments, the Working Group also welcomed and received comments from the following public members who did not register prior to the meeting but wished to comment and registered onsite.
Stephen McFaddon: Stephen identified himself as an independent scientific research advocate on issues of chemical injury and chemical sensitivity. He stated that the fields of immunology, infectious disease, allergy, immunotoxicology, and autoimmunity are being held back by a lack of investment and progress in scientific instrumentation. He expressed his view that the U.S. government should invest in a “human immunome project,” similar in scale and investment to the human genome project, as a way to advance the instrumentation used in the above-mentioned fields and foster scientific progress.
Deborah Olsen: Debra asked the Working Group if anyone has spoken to insurance companies about how or if they will cover treatment for people with tick-borne illness. She said that unless insurance companies, which she considered as contributors to the problem, are willing to cover treatment, patients they will remain sick regardless of progress made in other areas related to tick-borne disease.
Tray Cahill: Tray identified himself as a public health analyst who uses GIS to conduct surveillance on vector-borne diseases. He noted that in 2016/2017, CDC developed a surveillance repository for vector-borne diseases. He then asked if CDC will have a similar type of repository specifically for tick-borne diseases.
Following the public comments, one Working Group member urged CDC to state on its website that Rocky Mountain spotted fever is a human disease condition that is transmitted by the lone star tick
Summary of the Morning’s Discussion
Leigh Ann summarized the morning’s discussions and David offered comments about the progress made during the meeting thus far. The Working Group then took a break for lunch.
Led by David, the Working Group discussed how to organize subcommittees. They debated the pros and cons of different approaches.
One approach proposed by David would be to organize subcommittees based on disease types (in other words, Lyme disease with a focus on chronic symptoms, rickettsial diseases, ehrlichial diseases, anaplasmosis, babesiosis, diseases caused by tick-borne viruses, and alpha-gal syndrome). Under this approach, each subcommittee would address all aspects of the disease, including causes, prevention, treatment, vigilance, diagnosis, diagnostics, duration of illness, intervention, and pathogenesis. David explained that the rationale for this approach is that every disease is different.
Leigh Ann added that the subcommittees should tie back to the Working Group’s objectives, which were outlined earlier in the meeting.
A few Working Group members expressed different opinions about the approach proposed by David. While some members pointed out that the focus of the Working Group should be on Lyme disease because of the large number of Lyme disease cases, others noted that certain topics such as prevention could cross different disease types and therefore suggested organizing the subcommittees based on expertise.
Another approach proposed by Sam would be to have one subcommittee focusing on ticks, given that all tick-borne diseases start with ticks. This subcommittee would address prevention, environmental and personal protection, and tick vaccine. He proposed forming two subcommittees on Lyme disease, one devoted to pathogenesis and transmission and the other to diagnosis and treatment. He suggested forming an additional subcommittee to address rickettsiosis, anaplasmosis, and perhaps Rocky Mountain spotted fever.
David pointed out that the diseases are different and should be addressed separately. He noted that, according to the 21st Century Cures Act, all of these diseases need to be addressed.
Other members pointed out that the following topics should also be addressed.
- Alpha-gal allergy
- Integrated management
- Education, including patient, public, and clinician education
- Access to care
Leigh Ann noted that reimbursement, access to care, and education go hand-in-hand. Other members agreed. As a result, reimbursement and access to care will be addressed by the training/education subcommittee. Leigh Ann added that, while the Working Group cannot solve all the problems, they do need to present them and make recommendations to address them. Other members agreed that the Working Group needs to address the community’s concerns and help the patients, especially those with persistent symptoms. It was generally agreed that the subcommittee on Lyme disease will focus on chronic Lyme disease.
The Working Group members debated whether alpha-gal allergy should be a separate subcommittee. While some members suggested combining it with other diseases due to resource constraints, others asked to keep it separate because it is unique and affects many people, and public comments show that it is a significant public concern.
David suggested using the opportunity to address rickettsial diseases, anaplasmosis, babesiosis, and diseases caused by tick-borne viruses to prevent potential issues in the future.
Ben suggested that the Working Group keep the audience for their 2020 Report in mind and think about how the Working Group would like to develop their final report based on subcommittee reports. To effectively communicate with Congress and achieve a desired outcome, he suggested that the final report be issue oriented.
Leigh Ann suggested that the Working Group go through the list of proposed topics, prioritize the issues, and vote on the proposed subcommittees.
After further discussion, the Working Group voted on the following eight proposed subcommittees.
- Tick Biology, Ecology, and Control
- Pathogenesis and Physiology of Lyme Disease
- Clinical Aspects of Lyme Disease, which will discuss diagnosis, treatment, and vaccine
- Training and Education
- Some Working Group members suggested that this subcommittee cover all tick-borne diseases, address access to care, and perhaps also list government agencies’ accountabilities.
- Alpha-gal Allergy
- Ehrlichiosis and Anaplasmosis
- Babesiosis and Tick-borne Viruses
Voting Result: The Working Group unanimously voted yes to accept the list of subcommittees.
Leigh Ann suggested getting guidance on standardizing the subcommittee reports to make it easier for the Working Group to integrate the subcommittee reports into their final report. Ben suggested that the subcommittees develop their own outlines. Dennis suggested referencing the 2018 TBDWG report when needed to avoid duplications.
David explained that each subcommittee will have two co-chairs, one of whom will be a public member and the other a Federal member. Members of the Working Group volunteered to serve on the subcommittees as follows.
- Tick Biology, Ecology, and Control Subcommittee
- Co-chairs: Adalberto (Beto) Pérez de León and Robert (Bob) Sabatino
- Pathogenesis and Physiology of Lyme Disease Subcommittee
- Co-chairs: Leith Jason States and Sam T. Donta
- Clinical Aspects of Lyme Disease Subcommittee
- Co-chairs: Commander Rebecca Bunnell and Sam T. Donta
- Training and Education Subcommittee
- Co-chairs: Rebecca Bunnell and Pat Smith
- Alpha-gal Syndrome Subcommittee
- Co-chairs: Angel M. Davey, Scott Palmer Commins, and Leigh Ann Soltysiak
- Rickettsiosis Subcommittee
- Co-chairs: Estella Jones/Todd Myers and David Walker
- Ehrlichiosis and Anaplasmosis Subcommittee
- Co-chairs: Dennis M. Dixon and David Walker
- Babesiosis and Tick-borne Viruses Subcommittee
- Co-chairs: Ben Beard and Eugene David Shapiro
Voting Result: The Working Group members in attendance unanimously voted yes to accept the list of subcommittee co-chairs.
Jim explained that the process of forming subcommittees for the 2018 Working Group took a long time because there was an elaborate application process. To save time and improve efficiency for the 2020 Working Group, the subcommittee co-chairs are therefore responsible for forming their own subcommittees. He added that the co-chairs will need to identify and invite experts whose knowledge fits within their subcommittee’s scope of work to join their subcommittee.
In response to questions from Working Group members, David clarified that there is no limit on the number of members for the subcommittees, and that the Working Group does not need to approve subcommittee members.
To avoid duplication, Jim suggested that the subcommittee co-chairs share with the whole Working Group the experts they would like to invite prior to extending the invitation.
The Working Group also discussed how to obtain information from relevant Federal agencies through a data call. Ben shared that for the 2018 report, the previous Working Group used an inventory to gather information; however, the subcommittees did not get a chance to use the responses the Working Group eventually received because of time constraint.
The Working Group members agreed that they need to be specific about the questions they would like to ask each agency. David asked Ben, Dennis, and Rebecca to help draft a data call. Ben noted that the Working Group will need to review the draft data call and reach a consensus on the questions.
Jim explained that information associated with the data call will need to be addressed in public meetings and posted online. He noted that his team will share the previous data call with the Working Group members, so that they could use it as a reference.
In response a question from one of the Working Group members, Jim clarified that the group of three Federal members (Ben, Dennis, and Rebecca) who will draft the data call does not constitute a subcommittee.
The Working Group then discussed what the subcommittee reports should look like. It was generally agreed that a standardized template would help the subcommittees develop their reports, and standardized subcommittee reports would then help the Working Group write their final report.
To develop a template, it was suggested that the Working Group ask a support contractor to review the 2018 subcommittee reports and update the Working Group on the following:
- What sections the subcommittee reports should contain.
- What the final subcommittee report should look like, including;
- Common topics;
- Ballpark number of pages; and
Voting Result: The Working Group members in attendance unanimously voted yes to pass the suggestion.
Jim explained that the Working Group has funding to form three ad hoc committees to work with a government contractor to conduct brief literature reviews, or topic development briefs, on specific questions related to tick-borne diseases. The ad hoc committees will develop the questions and set review criteria, and the contractor will conduct literature reviews and report on findings. He explained that the reviews will not be systematic reviews or analyses due to the limited funding, and the brief reports will be due in September of 2019.
Leigh Ann asked the Working Group members to identify topics they felt should be addressed in the topic development briefs. She noted that information gathered through the process could serve multiple subcommittees.
Members of the Working Group suggested the following topics.
- Causes of the increases in tick-borne diseases in the United States
- Transmission during pregnancy
- Clinical/real-world evidence and gaps around disability manifestation caused by tick-borne diseases
- Associated costs and economic impact of tick-borne diseases
- Costs of persistent tick-borne diseases
- Causes of symptoms of Lyme disease
- Direct diagnostic tests available for tick-borne diseases
The Working Group member agreed that economic impact of tick-borne diseases is a gap; however, they also agreed that a brief literature review may not reveal much useful information because there are not sufficient published data.
Leigh Ann asked Scott if he would like to use the opportunity to discuss alpha-gal allergy. Scott responded that a brief literature review may not be adequate to gather meaningful information.
Based on the discussion, the Working Group chose the following three umbrella questions and members of the Working Group volunteered to help develop literature search criteria.
- What are the causes of the increases in tick-borne diseases in the U.S.?
- Volunteers: Beto and Bob
- What are the direct diagnostic tests available for tick-borne diseases and what are their current states?
- Volunteers: Ben and Leigh Ann
- What are the causes of the persistent symptoms of Lyme disease?
- Volunteers: Rebecca and Sam
Regarding public comments, Bob suggested utilizing new technology to help facilitate the large volume of public comments the Working Group continues to receive through emails. Leigh Ann responded that she hopes the Working Group will continue utilizing new technology.
David summarized that the Working Group has successfully selected subcommittee co-chairs, who will take the lead in forming subcommittees and developing outlines for subcommittee reports. He noted that the Working Group will use the topic development briefs to answer the questions the Working Group has discussed.
Leigh Ann expressed her gratitude for the opportunity to work with all the Working Group members. She noted that the Working Group is building upon the momentum of the 2018 Tick-Borne Disease Working Group Report to Congress to get more work done moving forward. She thanked the public for attending the meeting, and she encouraged the public to continue providing input.
David announced that the next public meeting will be a teleconference in July or August of 2019. It was agreed that the Working Group will conduct a poll to schedule the meeting.
The meeting was adjourned at 4:30 pm.
Leigh Ann Soltysiak,MS, Owner, Principal, Silverleaf Consulting, LLC; Adjunct Professor, Stevens Institute of Technology, Entrepreneurship Thinking
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
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
Commander 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
Scott Palmer Commins, BS, MD, PhD, Associate Professor of Medicine & Pediatrics, University of North Carolina; Member, UNC Food Allergy Initiative, Thurston Research Center
Angel M. Davey, PhD, Program Manager, Tick-Borne Disease Research Program, Congressionally Directed Medical Research Programs, U.S. Department of Defense
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 (absent) - Samuel 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
Captain Estella Jones, DVM, Deputy Director, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, U.S. Department of Health and Human Services (absent) - Commander Todd Myers, PhD, HCLD (ABB), MB (ASCP), Office of Counterterrorism and Emerging Threats, Office of the Chief Scientist, Office of the Commissioner, U.S. Food and Drug Administration, U.S. Department of Health and Human Services (alternate present)
Adalberto (Beto) Pérez de León, DVM, PhD, MS, Director, Knipling-Bushland U.S. Livestock Insects Research Laboratory, United States Department of Agriculture—Agricultural Research Service
Robert (Bob) Sabatino, Founder and Executive Director, Lyme Society Inc.
Eugene 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
Vanila M. Singh, MD, MACM, Chief Medical Officer, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services (Absent)
Patricia V. Smith, President, Lyme Disease Association, Inc.
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
HHS Support Staff
James (Jim) Berger, MS, MT (ASCP), SBB, Designated Federal Officer, Tick-Borne Disease Working Group, Senior Blood and Tissue Policy Advisor, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services
Kaye Hayes, MPA, Alternate Designated Federal Officer, Tick-Borne Disease Working Group, 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
Nicole Greene, Senior 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
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