October 5th, 2022
Note: For context and clarity, speaker credentials will be included upon first mention in each meeting’s summary. Subsequently, individuals will be referenced by their first names to equalize expertise across the many diverse disciplines represented in this document. All perspectives and expertise, including patient-lived experience, is valued equally. Speaking on a first-name basis helps the Tick-Borne Disease Working Group ensure that all voices are heard and valued based on merit and without the bias of titles, eminence, or prestige.
Welcome and Roll Call: Day 2
James (Jim) Berger, MS, MT (ASCP), SBB, 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 (HHS); Designated Federal Officer for the Tick-Borne Disease Working Group,welcomed participants and called the meeting to order. Jim conducted roll call (see Appendix 1: Tick-Borne Disease Working Group Members and HHS Support Staff). The meeting began with a quorum.
Recap of Day 1 and Day 2 Agenda
Holiday Goodreau, Executive Director, LivLyme Foundation; Co-creator, TickTracker; Working Group Co-Chair, greeted attendees and summarized proceedings from the previous day’s Tick-Borne Disease Working Group meeting. These included a presentation on the Vector-Borne Disease National Strategy, a vote on the order of the chapters, a progress update on the Public Comments chapter, and reviews of the Tick Ecology, Presentation and Pathogenesis, and Diagnostics chapters, including votes for their approval.
Linden Hu, MD, Tufts University School of Medicine, Professor Microbiology and Medicine; Working Group Co-Chair, introduced the agenda for Day 2, which featured the following items:
- Final Review of Comments, Progress Updates, and Votes on individual chapters
- Disease Prevention and Treatment (Progress Update)
- Access to Care (Final Review of Comments and Vote)
- Review and vote on the Federal Advisory Committee (FAC) Recommendation and Implementation (“non-FAC”) Recommendation
- Unresolved Issues
- Review of Meeting 23 and Next Steps
Disease Prevention and Treatment Chapter Review
Linden opened the discussion of individual chapters and member feedback by explaining that each member would explain their comment, as well as any recommended revisions. Chapter authors would then have an opportunity to respond. Subsequently, Working Group members would be able to discuss each comment. Linden noted that this chapter still has unwritten sections, and a vote was unlikely to be held to approve the chapter until a later meeting. Cat Thomson, Contractor, Rose Li Associates, was present to display chapter material and record Working Group decisions made to address each comment.
Discussion on General Aspects of the Chapter
In reviewing the general edits that had been made, Cat confirmed that the recommendations had been moved to the front of the chapter. She also noted that the graphics are still being updated. Dennis Dixon, PhD, Chief, Bacteriology and Mycology Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, HHS, and Sunil Sood, MD, Chair of Pediatrics, South Shore University Hospital, Attending Physician, Infectious Diseases, Cohen Children’s Medical Center, Professor of Pediatrics at Hofstra/Northwell, noted that the diseases had also been reordered in the latter half of the chapter.
Comment 1 from Betty Maloney
Elizabeth (Betty) Maloney, MD, President, Partnership for Tick-borne Diseases Education, commented on a sentence that might not be necessary. Sunil agreed that it was redundant, and Cat removed it.
Comment 2 from Holiday Goodreau
Holiday noted that the trade name of a vaccine is named in a passage—she recalled a previous discussion about not naming companies or brands in the report. Dennis noted that it was important to be fair when portraying competitive business efforts; in this case, the vaccine named was the only one close to release for this particular indication. Kirby C. Stafford III, PhD, Chief Scientist and State Entomologist, Department of Entomology, Center for Vector Biology & Zoonotic Diseases, The Connecticut Agricultural Experiment Station, noted that a similar instance occurred in the Tick Ecology chapter, and the trade name of the product was removed. Linden expressed interest in avoiding conflicts of interest by removing trade names. Betty agreed and stated that consistency on this approach was needed throughout the report. In the example in the Tick Ecology report, the unnamed product was the only one available for the usage in question. Linden observed that other competitors to the vaccine named in the Disease Prevention and Treatment chapter did exist but were further behind in development. Charles Benjamin (Ben) Beard, PhD, Deputy Director, Division of Vector-borne Diseases, Centers for Disease Control and Prevention, HHS, noted that the key issue is whether or not the language appears to endorse a product or not; regardless, he preferred consistency across the report. 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, proposed taking the names of products out of the report. CAPT Rebecca Bunnell, MPAS, PA-C, Senior Advisor, Learning and Diffusion Group, Center for Medicare & Medicaid Innovation, Centers for Medicare & Medicaid Services, HHS, agreed with Todd. Dennis opted to remove the named product. Cat made the edit.
Comment 3 from Holiday Goodreau
Holiday praised the chapter authors for including gestational Lyme disease in the chapter.
Comment 4 from Betty Maloney
Betty made a comment on a passage about the findings of a group of studies. Sunil noted that the preceding paragraph contextualized the reference to the studies. Betty agreed that the statement was contextualized and qualified well and withdrew her comment.
Comment 5 from Betty Maloney
Betty explained that her comment involved a referenced study; she recommended adding another reference to help support the claims. Sunil agreed and Betty indicated she would send him the reference. Monica E. Embers, PhD, Associate Professor and Director of Vector-borne Disease Research, Tulane National Primate Research Center, supported this decision via chat.
Comment 6 from Betty Maloney
Betty suggested adding a qualifier to a generalization about long-term antibiotic courses. Sunil agreed, and Dennis suggested an edit to describe clinician concern for adverse effect on patients due to antibiotic resistance. Betty responded that the intent of her comment was to ensure the risk of not treating with antibiotics was captured in the text. Dennis proposed language that balances the risks and benefits to treatment—which Betty explained was the point she was trying to make.
Comment 7 from Sunil Sood
Sunil noted that he reinstated a passage that was mistakenly deleted.
Comment 8-9 from Monica Embers
Sunil noted that Monica had sent two suggested edits at the end of Day 1 of the Working Group meeting. He proposed incorporating her suggestions into the passages in question. Betty stated that a reference to one study’s findings in the passage was not accurate—based on the findings of another study of patient fatigue. Dennis noted that the chapter discusses this topic in another section, but Betty raised concerns that the passage in question appears to negate that point. Betty provided Dennis some details about the study she was questioning. Dennis responded that a related study explained this dynamic well but could not recall the exact verbiage. Betty suggested an edit, and Working Group members agreed to the change. Cat updated the passage and added references mentioned during the discussion of this section.
Discussion on Rationales for Recommendations
Holiday questioned why rationales had not been written for the recommendations in the Disease Prevention and Treatment chapter. Dennis noted that this chapter’s writing group had thus far focused on developing the content in the remainder of the chapter. She noted that having the recommendations at the beginning of the chapter was a format that could be potentially used for all chapters; Holiday planned to raise this at the end of the meeting.
Cat presented an example from a previous report of how the rationales could be displayed. In the example, the rationales appear directly under the recommendations. Kirby expressed agreement with this format. Betty agreed and noted that a change to the format would lead to substantial edits. Gaby proposed putting all recommendations and rationales at the beginning of the report. Linden and Holiday expressed interest in Gaby’s proposal. Rebecca agreed with other members that rationales for recommendations should be included in the report. She proposed the idea of setting them side-by-side graphically. Linden noted that the consensus of the Working Group was to include rationales with the recommendations in all chapters and advised Dennis and Sunil to add them to their chapter.
Discussion and Vote on the FAC and Implementation Recommendations
Holiday opened the discussion on the FAC recommendation by providing some background. She noted that the Tick-Borne Disease Working Group is a committee under the Federal Advisory Committee Act (FACA), which was authorized by Congress as part of the 21st Century Cures Act. The Working Group was mandated to produce three reports to Congress over a six-year period, which ends on December 13, 2022. Holiday noted that there are two ways for an FAC to be renewed: new legislation passed by Congress or a renewal through HHS. Holiday also discussed the timeline for renewing an FAC.
Holiday explained that the writing group responsible for drafting the FAC and implementation recommendations held several meetings during which members debated the continuation of the Working Group and how to ensure implementation of the Working Group’s recommendations. Ben proposed a recommendation for a non-FAC entity. He argued that due to the cost shouldered by HHS agencies to continue the Working Group, some federal Working Group members believe that the funds could be better spent fulfilling the recommendations made by the Working Group during its six-year tenure. Some of the non-federal Working Group members expressed concern about the future of tick-borne disease work and advocated to ensure the Working Group’s recommendations are fulfilled. Holiday observed that, overall, members agree that it is time to transition from making recommendations to implementing them. She informed the Working Group that they will hold a discussion and vote on both the FAC and implementation recommendations.
Linden stated that the discussions that took place while drafting the proposed recommendations were productive and collegial, and focused on the best ways to care for patients and advance research on tick-borne diseases and associated illnesses. Ben clarified that while cost is a concern, the bigger issue relates to ensuring that resources are prioritized toward implementation of all Working Group recommendations. Ben added that implementation and operations are beyond the scope of an FAC. He highlighted the importance of maintaining ongoing dialog with advocacy groups as the research evolves—which includes regular communication and progress updates.
Betty underscored the importance of ensuring transparency with the public during the implementation process. She observed that the Working Group has created an important connection between the federal government and advocacy communities. Ben stated that a central part of his recommendation was to continue contact and dialogue in order to maintain these connections. Betty expressed concern that the new Vector-Borne Disease National Strategy is not as transparent as the Working Group; Ben responded that the recommendation he is making would include public meetings to ensure transparency. Leith Jason States, MD, MPH (FMF), Deputy Chief Medical Officer, Office of the Assistant Secretary for Health, HHS, emphasized the importance of public meetings—he also noted that National Strategy RFIs are meant to meaningfully gather public input.
Dennis described his previous experience in an organization similar to the Working Group focused on antimicrobial existence. He noted that after the group met for ten years and made nearly 100 recommendations, the group shifted to annual meetings in order to provide updates on the progress toward fulfilling recommendations, and maintaining engagement and communication between its members. Jennifer added that Ben’s proposal can get approved immediately and did not require an act of Congress. Todd agreed with some of the other federal Working Group members that the time for recommendations has passed and implementation should be the focus of action to address tick-borne diseases. He expressed optimism for the National Strategy, which may be able to mandate implementation of the Working Group’s recommendations.
Gaby observed that both the recommendations to create a new FAC and a non-FAC entity fall short of ensuring that all stakeholders can remain engaged in the implementation process. Monica commented via chat that tick-borne disease is unlike any other public health issue, and she believed it was essential that all stakeholders stay engaged. Rebecca emphasized the importance of developing diagnostics as stakeholder groups work to increase access to care for patients.
Recommendation Language
Cat displayed the FAC and implementation recommendations for discussion and potential revision by the Working Group.
FAC Recommendation
The Working Group reviewed the FAC recommendation first. The draft read as follows:
We request that Congress and/or the U.S. Department of Health and Human Services sponsors a new Federal Advisory Committee (FAC) focused on the prioritization and implementation of recommendations from the Tick-Borne Disease Working Group’s 2018, 2020, & 2022 report[s] and generate new recommendations as needed. This FAC would be made up by a diverse group of representatives of relevant federal agencies and public stakeholders, including patients and patient advocates as well as clinicians and researchers who represent the full spectrum of clinical and scientific perspectives on tick-borne diseases.
Rationale: The three cycles of the Tick-Borne Disease Working Group included 19 subcommittees, covered a variety of topics, and generated XX recommendations. To date, many of the recommendations have not been implemented. The focus of the new FAC will be to prioritize and potentially reframe previous recommendations so as to provide additional input to the responsible agencies and to monitor implementation of previous recommendations. FAC members would include a diverse group of federal and public stakeholders, including patients or patient advocates who can represent the patient community, as well as clinicians and researchers who represent the full spectrum of clinical and scientific perspectives on tick-borne diseases.
Kirby recommended adding the total number of recommendations to the rationale. Jennifer and Linden both questioned how to deal with the costs of having federal partners on the proposed FAC. Linden inquired if there was interest in stipulating limits in order to increase productivity and reduce costs. Jim advised the group that the mandated funding limits for an FAC would be legislated by Congress; however, HHS would create a charter for guidance on meeting frequency.
Betty underscored that the rationale for the FAC is to enable patient advocates to be involved in shared decision making with federal partners. She envisioned an organization different from the past iterations of the Working Group, which would require less effort from federal partners and an increased focus on implementation of policies. Dennis noted that FACs have minimum requirements for meetings and reporting, which may create more work than is initially intended. 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, verified that certain actions are required as part of the Sunshine Act. This includes publication of meeting agendas and allowing for public comment; however, the frequency of meetings depends upon the charter—which is written by HHS officials. Gaby emphasized the importance of monitoring funding of efforts related to Working Group recommendations, which Kaye noted also depends on the language of the charter. Kirby recommended adding ‘monitoring progress’ to the goals of the FAC recommendation. Holiday pointed out that public advocates are not involved in writing the charter. Ben noted that CDC has line items for diseases that delineate priorities for the agency, which is not congruent with Gaby’s suggestion. Rebecca noted that the only way advocates could be involved then, would be a providing input in some way to these budgetary decisions; however, other agencies may have different budgetary processes.
Linden proposed identifying limits to the number of meetings in the FAC recommendation to address concerns about the level of effort required from federal partners. He proposed two meetings per year. Betty stated that three meetings is appropriate for the first year of a new FAC, and suggested loosening the requirement for the maximum number of meetings. Ben noted that the Vector-Borne Disease National Strategy Group does allow for public meetings and input on prioritization of Working Group recommendations.
The revised FAC recommendation read as follows:
We request that Congress and/or the US Department of Health and Human Services sponsors a new Federal Advisory Committee (FAC) focused on the prioritization, implementation, and progress of recommendations from the Tick-Borne Disease Working Group’s 2018, 2020, & 2022 report and generate new recommendations as needed. This FAC would be made up by a diverse group of representatives of relevant federal agencies and public stakeholders, including patients and patient advocates as well as clinicians and researchers who represent the full spectrum of clinical and scientific perspectives on tick-borne diseases. This FAC would be limited to meeting no more than three times yearly.
Implementation Recommendation
The Working Group then reviewed the implementation recommendation. The draft read as follows:
Request that following sunset of the TBDWG, HHS’s Office of Science and Medicine (OSM) convene regular (e.g., semi-annual or annual) virtual public [co-creation and collaboration workshops], in concert with relevant HHS operating divisions (CDC, FDA, NIH, and CMS) to share updates and receive feedback on progress made towards implementation FAC recommendations from the three reports to Congress. The recommendations should be tracked back to the Goals, Strategies, and Objectives of the National Strategy, of which HHS/OSM is currently leading the development, to ensure progress is made on recommendations, as resources allow. Through these regularly convened public [town halls], public feedback should be collected and an open dialog should be supported to ensure continued, meaningful engagement with the tickborne disease community (including patients, advocates, scientists, clinicians, and educators).
Rationale: The current federal advisory committee has now completed three full cycles, thus fulfilling the original legislative mandate of the 21st Century Cures Act. From the three formal reports, including the pending 2022 report, over 70 recommendations have been made as ways that the federal government can address concerns related to tick-borne disease prevention, control, surveillance, diagnostics, treatment, education, and access to care. Over 20 public meetings and 100s of subcommittee meetings have been held. Hundreds of participants have been engaged in the process, including patients, patient family members, advocates, scientists, healthcare providers, public health practitioners, and representatives from government, education, non-profits, and private sector entities. Written and oral have been received from patients and family members affected by tick-borne diseases. Significant progress has been made, and the process has been highly successful. While more work still needs to be done, subcommittee reports have become increasingly redundant, and in some cases, the same recommendations are being repeated, acknowledging the fact that many recommendations remain unaddressed due in part to budgetary needs but also due to the fact that science takes time. The process is now at a juncture where the next best next step must be determined for addressing the continuing challenges. The need has evolved from assessing gaps and receiving recommendations, efficiently and effectively, which is an operational function and not a function of a federal subcommittee, but of the federal government itself. Continuing the current working group comes at significant cost and in terms of the time commitment related to participating in the working group, in subcommittee meetings and in associated writing efforts. This work detracts from time and resources that would otherwise be spent in implementation efforts. A more effective approach is needed, one that represents better stewardship of limited federal resources. There remains a highly significant need for meaningful communication and interaction on implementation needs and priorities, but this work can be more efficiently and effectively achieved through an HHS-led process as described in the recommendation.
Holiday disagreed with the passage in the rationale stating that significant progress has been made. Ben responded that the progress may seem less significant compared to the work that remains to be done to address tick-borne diseases. He approved of Holiday’s suggested revision to remove significant.
Betty also pointed out a passage in the rationale she did not agree with regarding the next steps to meet continuing challenges; Betty emphasized that prioritization of recommendations must be included in next steps. Furthermore, Betty underscored the importance of patient advocates being involved with decision-making processes. Ben responded that conflicting priorities between advocates for research, treatment, diagnostics, and other topics make prioritization challenging. Jennifer proposed Working Group members rank recommendations and collate the responses. She also proposed the development of a dashboard for progress on addressing tick-borne diseases. Ben responded that a dashboard would be challenging to implement, and the process of sharing updates and receiving feedback could be done via other means.
Linden stated that the implementation and FAC recommendations were compatible—and that one could follow the other. He suggested rewording the content to make that apparent. Holiday agreed. Todd proposed a combination of the two recommendations along with metrics to ensure progress. He expressed the need to start work immediately on implementation with the understanding that the FAC option would still be available if progress is inadequate. Kirby echoed concerns that another FAC would simply repeat work that has already been done by the Working Group. Betty reiterated that a new FAC would be focused on implementation rather than generating new recommendations.
Ben revised the implementation recommendation to emphasize regular meetings, technical consultations, and public engagement. Betty questioned how these exchanges would fit into the implementation process. Ben responded that members would have ongoing discussions about the progress of implementing Working Group priorities. Gaby inquired about any potential risks of starting a non-FAC group and then applying for another formal FAC. Holiday noted that the recommendations have to be voted on separately. Linden commented that the revised implementation recommendation advances the Working Group’s mission, but underscored the need to explicitly address public trust in the process.
Leith reminded the group that the Office of Infectious Disease and HIV/AIDS Policy (OIDP) has stewarded the Working Group and helped to build the public trust. He suggested nominating Office of the Assistant Secretary for Health (OASH), which is the parent organization for OIDP, to continue to steward this non-FAC group.
The revised implementation recommendation read:
Request that following sunset of the TBDWG, HHS’s Office of the Assistant Secretary for Health (OASH) convene regular virtual public co-creation or collaboration workshops and technical consultations, in concert with relevant HHS operating divisions (CDC, FDA, NIH, and CMS) and with other relevant federal departments to share updates and receive input on progress made towards implementation FAC recommendations from the three reports to Congress. The recommendations should be tracked back to the Goals, Strategies, and Objectives of the National Strategy, of which HHS/OASH is currently leading the development, to ensure progress is made on recommendations, as resources allow. Through these regularly convened public engagement sessions, public input should be collected and an open dialog should be supported to ensure continued, meaningful engagement with the tickborne disease community (including patients, advocates, scientists, clinicians, and educators).
Motions and Votes
Jennifer made a motion to vote to accept the revised implementation (non-FAC) recommendation. Fourteen members voted yes; the motion carried unanimously.
Betty made a motion to vote accept the FAC recommendation. Six members voted yes; eight members voted no; the motion failed.
Sunil made a motion to reopen the vote on the FAC recommendation. The motion was not seconded, the motion failed.
Revision of the Implementation Recommendation Rationale
Betty commented that the detail about the history of the Working Group in the implementation recommendation rationale was unnecessary. Ben agreed with the edit. Betty suggested taking out the language about costs to government agencies; Gaby agreed with the sentiment and suggested making a revision to ensure the rationale did not reference the FAC recommendation, which did not pass. Jennifer, Dennis, and Rebecca supported the idea of changing this particular passage. Rebecca suggested giving Ben time to revise and present a new draft at the next Working Group meeting. Members agreed, and a presentation and vote will occur at that time.
Access to Care and Education Chapter Review
Linden opened the discussion of the Access to Care and Education chapter to review member comments. Cat was present to display the content and record Working Group decisions made to address each comment.
Review of Access to Care and Education Recommendations
Linden explained that the Working Group had not previously voted on the first two recommendations for this chapter and advised the working group to review them before the rest of the chapter. Betty agreed. Linden and Rebecca also noted that the two recommendations written for this chapter were contingent on the Working Group’s approval of the FAC recommendation: should it not pass, only the first of the two recommendations would be presented in this chapter (and the second would not). The first recommendation reads as follows:
U.S. Department of Health and Human Services (DHHS) to sponsor a Federal Advisory Committee on tick-borne diseases (TBD) that will conduct a comprehensive review of tick-borne disease information on DHHS websites and training materials to determine whether they best reflect the current state of the science, independently analyze clinical trial evidence in detail, and appropriately delineate areas of scientific and therapeutic uncertainty.
Ben noted that the Information Quality Act essentially fulfills the role of the recommendation. He added that activities in this recommendation would be accomplished as part of the implementation (non-FAC) recommendation. Betty stated that engaging with the Information Quality Act is cumbersome and opaque; the expertise and biases of individuals responding to requests for revision are unknown. She provided an example where the reviewer lacked the expertise to adjudicate a complaint. Betty underscored that having guidelines that clearly communicate the state of the science allow clinicians to provide the best care possible. Ben suggested eliminating the FAC language and have HHS conduct a comprehensive review of the items listed.
Todd expressed concern about the language of independently analyzed clinical trial evidence. He explained that FDA already has independent reviewers who examine clinical trial findings, and HHS should not be put in a position to disregard what has been previously approved. Dennis pointed out that review is inherent to scientific research in the form of reviews and responses to publications; he advocated for more research on the presentation and pathogenesis of tick-borne diseases to move the science forward. Betty underscored that uncertainty is not communicated in the training modules. She stated that the intention of the recommendation is to communicate the scientific uncertainty across HHS agency websites and training modules.
Kirby echoed Ben’s comment that HHS could sponsor a review of its materials without an FAC. Betty disagreed and stressed the importance of a non-federal review. Kirby questioned if there were another independent means of review besides an FAC. Linden proposed that agencies overseeing the Working Group might have more trust from the advocacy community to fulfill this oversight role.
Betty explained that the second recommendation was meant to be an alternative if the Working Group rejected the first recommendation. It read as follows:
Provide funding for U.S. Department of Health and Human Services (DHHS) to conduct a comprehensive review of tick-borne disease information on DHHS websites and training materials to determine whether they reflect the current state of the science, independently analyze clinical trial evidence, and delineate areas of scientific uncertainty. The review should include meaningful stakeholder engagement.
Jennifer added that the last sentence should specifically reference public stakeholders. Gaby asked federal partners how this recommendation would be acted upon. Leith and Ben both expressed uncertainty for how it would be fulfilled in practice. Betty offered to revise the recommendation to specifically review the state of the science on erythema migrans (EM) rashes and persistent/chronic Lyme disease to ensure that teaching materials are in accordance with the evidence. Leith noted that the premise of the review was unworkable because each agency (such as NIH, CDC, FDA) has a different missions and approach to its review of the science.
Linden asked the Working Group if there were a way to use an existing federal structure to ensure a review of agency websites and training modules. Gaby observed that the federal representatives have acknowledged that review processes are in place, but they may not be keeping up with the state of the science. She suggested revising the recommendation to include improvement of those review processes. Ben noted that CDC websites now state that the science is unsettled to accommodate the differing viewpoints. However, Linden pointed out that the recommendation is worded agnostically and does not take a position. Betty agreed. In an effort to formulate a recommendation that would work within HHS, Todd questioned what the end product might be. Betty responded that it would be updated clinician education guidelines that reflect multiple perspectives from the research and advocacy communities. Dennis asked if the recommendation could focus on the groups that produce clinician training modules. Betty pointed out that CDC, the agency that creates these modules, carries so much weight that it can enable or inhibit clinical judgment.
Ben called the group’s attention to the recommendations in the Clinician and Public Education, Patient Access to Care chapter of the 2020 Working Group report. He explained that they are similar to those under consideration and suggested that the implementation (non-FAC) group could investigate how these recommendations were being acted upon. Linden suggested a stipulation for such a review could be added to the implementation recommendation; that said, the recommendation in the Access to Care chapter could be revised to reflect a more narrow, actionable course. Ben and Betty agreed to work on the language of the recommendation in order to come to consensus. The Working Group agreed to table the discussion.
Betty informed the Working Group that the third recommendation had been revised to reflect the nomenclature discussion of the previous meeting. Jim noted that if the recommendation had changed meaningfully, he recommended the Working Group vote to accept it. The recommendation read:
Fund and support continued and ongoing modification of the federal government websites, starting with the CDC and NIH websites, as well as educational materials and seminars for clinicians, the public, and public health departments to reflect the current state of the science related to persistent Lyme disease/chronic Lyme disease (PLD/CLD), which is limited, emerging, and unsettled and to acknowledge that there are divergent views on diagnosis and treatment of patients with PLD/CLD.
Linden noted that this third recommendation was similar to the second one just discussed. Dennis noted that the wording of this recommendation addressed his concerns about the second recommendation. Betty informed the group that she would work with Ben and Rebecca to combine the second and third recommendations and revise the language to reach consensus. Thus, the Access to Care and Education chapter will be completed with three recommendations. The first that is a combination of the first three—and the fourth and fifth, which have already been voted upon and approved by the Working Group.
The Working Group will vote on the chapter with revised recommendations at the next meeting.
Next, the Working Group reviewed comments and feedback related to the remainder of the Access to Care and Education chapter. Cat explained that she had worked with Betty to prepare the document for today’s meeting, and her comments were summaries of Betty’s revisions.
General Comment 1 reviewed by the Working Group
Cat noted that revisions had been made globally to the chapter to be more inclusive of Alpha-gal Syndrome (AGS) and tick-borne diseases other than Lyme disease.
General Comment 2 reviewed by the Working Group
Cat explained that the theme of health equity was emphasized more prominently throughout the chapter. Jennifer noted that Leith had written draft content regarding health disparities to be added to the introductory sentence. Betty commented that the language she used on health equity was pulled from the CDC website itself. Rebecca and Betty agreed to the change and Cat added the draft text.
General Comment 3 reviewed by the Working Group
Cat noted that a few sentences had been moved to improve clarity of the passage.
Comment 4 from Betty Maloney
Betty noted that an earlier revision in a particular passage had been completed.
General Comment 5 reviewed by the Working Group
Cat noted that a passage on community-based participatory research had been moved to a more appropriate location in the text based on earlier comments.
General Comment 6 reviewed by the Working Group
Cat commented that the conclusion had also been moved from another part of the chapter to the end for clarity and impact.
Comment 7 from Linden Hu
Linden observed that a quote from a physician in a particular passage could be highlighted graphically in a box beside the text. Betty agreed. Cat added a comment to ensure the graphic designer implements the change.
Comment 8-10 from Holiday Goodreau
Holiday noted that a few passages did not include tick-borne diseases other than Lyme disease. Betty agreed and Cat added comments in the draft so edits would be implemented.
Comment 11 from Holiday Goodreau
Holiday noted that one of the graphics states “tick-borne diseases” rather than illnesses. She suggested adding illnesses to make the graphic more inclusive of conditions like AGS.
Discussion of Unresolved Issues
Holiday invited Working Group members to raise any unresolved issues and concerns as the group prepared to conclude their 23rd meeting.
Schedule of Meeting 24
Working Group members discussed the scheduling of their final meetings and confirmed that the 24th meeting would take place on October 24th and 25th, 2022. Jim noted that all meetings require 15 days public notice. Members also discussed when the Working Group would sunset and the possibility of a meeting in early December.
Patient Stories
Linden noted that some Working Group members are collecting patient stories to display throughout the report. He explained that chapter leads want editorial oversight over which stories are displayed in their chapters. He added that Lauren Overman, MPH, CPH, Public Health Analyst, Office of Infectious Disease and HIV/AIDS Policy, HHS, is helping facilitate the process.
Review of Meeting 23 (October 4-5)
Linden provided Working Group members with a brief review of topics covered and accomplishments from the October meeting including:
- Voted on Order of Chapters and Recommendations
- Discussed Final Review of Chapter Comments and Voted
- Discussed Progress Updates
- Discussed Unresolved Issues
Linden noted that the following chapters have been completed and approved by the Working Group: Changing Dynamics of Tick Ecology, Personal Protection and Control; Diagnostics; and Clinical Presentation and Pathogenesis.
Discussion of Next Steps and What is Expected for Meeting 24 (October 24-25)
Linden presented the Working Group with the tasks that still need to be completed at the next meeting, as follows:
- Review and vote to approve the Executive Summary, Introduction, and Conclusion chapters
- Review and vote to approve the Disease Prevention and Treatment chapter
- Review and vote to approve Access to Care and Education recommendations and chapter
- Review and vote to approve the Public Comments chapter
- Review and vote to approve the rationale for the implementation (non-FAC) recommendation
- Addition of conclusion paragraphs for all chapters
- Agenda for the final meeting
- National Inventory Presentation
Meghan Walsh, PhD, Senior Associate, Center for Scientific Research, Rose Li & Associates, Inc., noted that the final date to submit draft chapters is October 17th.
Adjournment
The meeting was adjourned at 3:20 pm EST.
Appendix 1: Tick-Borne Disease Working Group Members and HHS Support Staff
Tick-borne Disease Working Group
In alphabetical order:
Co-Chair
Holliday Goodreau, Executive Director, LivLyme Foundation, Co-creator, TickTracker (Present)
Co-Chair
Linden Hu, MD, Professor of Microbiology and Medicine, Tufts University School of Medicine (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)
CAPT Rebecca Bunnell, MPAS, PA-C, Senior Advisor, Learning and Diffusion Group, Center for Medicare & Medicaid Innovation, Centers for Medicare & Medicaid Services, U.S. Department of Health and Human Services (Present)
Dennis 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)
Monica E. Embers, PhD, Associate Professor and Director of Vector-borne Disease Research, Tulane National Primate Research Center (Present)
Elizabeth Maloney, MD, President, Partnership for Tick-borne Diseases Education (Present)
Robert J. Miller, PhD, National Program Leader, Agricultural Research Service, U.S. Department of Agriculture (Present)
CDR Todd Myers, PhD, HCLD (ABB), MB (ASCP), Office of Counterterrorism and Emerging Threats, Office of the Chief Scientist, Office of the Commissioner, U.S. Food and Drug Administration, U.S. Department of Health and Human Services (Present)
Jennifer Platt, DrPH, Co-founder, Tick-borne Conditions United (Present)
Sunil K. Sood, MD, Chair of Pediatrics, South Shore University Hospital, Attending Physician, Infectious Diseases, Cohen Children’s Medical Center, Professor of Pediatrics at Hofstra/Northwell (Present)
Kirby C. Stafford III, PhD, Chief Scientist and State Entomologist, Department of Entomology, Center for Vector Biology & Zoonotic Diseases, The Connecticut Agricultural Experiment Station (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)
Gabriella Zollner (Romero), PhD, Program Manager, Deployed Warfighter Protection Program, U.S. Department of Defense (Present)
Alternative Federal Representatives
In alphabetical order:
Kristen Honey, PhD, PMP Executive Director of InnovationX, U.S. Department of Health and Human Services
RADM Estella Jones, DVM, U.S. Public Health Service, Deputy Director, OCTET U.S. Food and Drug Administration
Andrew Y. Li, PhD, Research Entomologist, Invasive Insect Biocontrol & Behavior Laboratory, U.S. Department of Agriculture
Samuel S. Perdue, PhD, Chief, Basic Sciences, Bacteriology and Mycology Branch at National Institutes of Health (Present)
CDR Monica Reed-Asante, PharmD, USPHS, Pharmacist, Senior Health Insurance Specialist for Centers for Medicare and Medicaid Services
LTC Michelle Colacicco-Mayhugh, PhD, PMP, Deputy Medical Entomology Consultant to the U.S. Army Surgeon General
HHS Support Staff
In alphabetical order:
James (Jim) Berger, MS, MT (ASCP), SBB, Designated Federal Officer, Tick-Borne Disease Working Group, Senior Blood and Tissue Policy Advisory, Office of Infectious Disease and HIV/AIDS Policy, U.S. Department of Health and Human Services
B. 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
Chinedu Okeke, MD, MPH-TM, MPA, Senior Policy Advisor, Office of Infectious Disease and HIV/AIDS Policy, U.S. Department of Health and Human Services
Lauren Overman, MPH, CPH, Public Health Analyst, Office of Infectious Disease and HIV/AIDS Policy, U.S. Department of Health and Human Services
Allison Petkoff, Public Health Analyst, Office of Infectious Disease and HIV/AIDS Policy, U.S. Department of Health and Human Services
Appendix 2: Writing Groups for the 2022 Report to Congress and the HHS Secretary
(Chapter leads are underlined.)
Executive Summary—Holiday Goodreau, Linden Hu,
Chapter 1: Introduction—Holiday Goodreau, Linden Hu, Ben Beard, Rebecca Bunnell, Monica Embers, Betty Maloney, Sam Perdue, Jennifer Platt, Leith States
Chapter 2: Methods—RLA
Chapter 3: Changing Dynamics of Tick Ecology, Personal Protection, and Control—Robert Miller, Kirby Stafford, Michelle Colacicco-Mayhugh, Jennifer Platt, Gabriella Zollner (Romero)
Chapter 4: Clinical Presentation and Pathogenesis—Ben Beard, Jennifer Platt, Leith States, Rebecca Bunnell, Monica Embers, Betty Maloney (resigned), Sunil Sood
Chapter 5: Diagnostics—Monica Embers, Todd Myers, Michelle Colacicco-Mayhugh
Chapter 6: Disease Prevention and Treatment—Dennis Dixon, Sunil Sood, Monica Embers, Sam Perdue, Jennifer Platt
Chapter 7: Access to Care and Education—Rebecca Bunnell, Betty Maloney, Leith States, Gabriella Zollner (Romero)
Chapter 8: Public Comment— Holiday Goodreau, Linden Hu, Lauren Overman, Jenifer Platt, Gabriella Zollner (Romero)
Chapter 9: Looking to the Future—Holiday Goodreau, Linden Hu
Chapter 10: Conclusions—Holiday Goodreau, Linden Hu
