October 25, 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 (OIDP), Office of the Assistant Secretary for Health (OASH), 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
Linden Hu, MD, Tufts University School of Medicine, Professor Microbiology and Medicine; Working Group Co-Chair, greeted attendees and summarized proceedings from the previous day’s Tick-Borne Disease Working Group meeting. These proceedings included:
- Review and Approval of the Disease Prevention and Treatment Chapter
- Presentation of the 2022 National Inventory of Tick-Borne Diseases and Associated Illnesses
- Review and Approval of the Access to Care and Education Chapter
- Discussion of Recommendation for the Access to Care and Education Chapter
Linden then introduced the agenda for Day 2, which featured the following items:
- Public Comments
- Public Comment Chapter Review and Vote
- Discussion on Implementation Recommendation and Rationale
- Executive Summary, Introduction, Conclusion, and Looking Forward Chapters Final Review and Vote
- Unresolved Issues
- Final Vote on the Report to Congress
- Review of Meeting #24
- Next Steps
Holiday welcomed public commenters and reminded the public of the three ways to engage with the Working Group: (a) providing oral public comments at public meetings, (b) submitting written public comments for a public meeting by email to firstname.lastname@example.org,and (c) sending comments any time by email to email@example.com.The last day for the public to submit written comments for inclusion in the Report to Congress is October 11, 2022.
John Dykers: John underscored the importance of clinicians. He also commented that disease data used for patient care in areas with high tick populations are inadequate. John implored clinicians to consider suspected tick bites with high suspicion to ensure early treatment, which leads to less costly outcomes—including disability and death. He provided an example of a University of North Carolina coach, Jim Tatum, who likely succumbed to a tick-borne infection. John stated that Jim was not treated promptly by clinicians because they were apprehensive about providing unnecessary treatment; and as a result, Jim died of multiple organ failure. John said treatment guidelines should be updated so clinicians are not afraid to treat patients.
Pamela Traina: Pamela stated that she is 55 years old, living in Los Angeles. She explained that she had Alpha-gal Syndrome (AGS) and had spent two years in and out of hospitals with anaphylactic reactions before she was diagnosed. Pamela noted that AGS is endemic in the southeastern United States, but she has never visited and does not recall being bitten by a tick; thus, she implored researchers to look for other vectors of this syndrome. She reported numerous food and medication allergies. Pamela stated that better diagnostic tests for AGS need to be developed, along with animal product reporting on product labels. She reported that hospitals are dangerous places for patients with AGS because of products that can trigger allergic reactions. Pamela reported encountering ignorance of AGS in hospital settings and being denied Benadryl and breathing aids.
Holly Ahern: Holly thanked the Working Group members for their work and noted that she was a patient advocate involved in the original 21st Century Cures Actlegislation. Holly expressed dismay that Long COVID has received significant attention from the federal government, while long-term Lyme disease receives less attention. She noted that acute and chronic Lyme disease affects many people, and there is still widespread misunderstanding in the medical community about this illness. Holly lauded the LymeX diagnostic challenge, but noted that public funding lags behind the private funding earmarked for this initiative. She stated that the Centers for Disease Control and Prevention (CDC) continues to recommend diagnostic tests that are inaccurate. She quoted the Access to Care and Education Subcommittee report, which calls for increased health equity for tick-borne disease patients.
Debbie Kimberg: Debbie stated that Lyme disease has a wide spectrum of symptoms. She said that her symptoms were mild yet involved emotional turmoil. Debbie stated that her son was diagnosed with autism spectrum disorder; however, at 10 years old he tested positive for several tick-borne diseases, including bartonellosis. Debbie reported that it took six years to locate a provider that would treat her son—and noted that his autism symptoms improved significantly after receiving a long-term course of antibiotics. She stated that he was able to move out of special education programs and his test scores increased. Debbie stated that her whole family is infected and wondered if increases in autism diagnoses can be attributed to the spread of tick-borne disease.
Joeleen Keilkucki: Joeleen stated that she is 44-years old and reported suffering from Lyme disease for several decades, which included numerous emergency room visits and hospitalizations. She stated that she had pleaded with her doctor to get tested for Lyme disease; despite his condescending manner, he agreed to have her tested. The test came back positive, and she received a 28-day course of antibiotics. Joeleen reported that her symptoms did not improve, and she remained in bed with nerve pain, migraines, and seizure-like symptoms. She stated that she was forced to find other providers, many of whom were dismissive and disrespectful about her illness.
Jackie Confalone: Jackie said she has been a Lyme disease patient for 18 years and resides in the high-incidence area of southeastern Pennsylvania. After being diagnosed in 2005, she lost function to do most tasks. Jackie was treated for neuropsychiatric issues, and her provider recommended she see a Lyme-literate doctor and get tested. She said the doctor saved her life, and she continues to receive treatment for ongoing infections. Jackie shared some data from a survey of other Lyme disease patients on their experiences in terms of the time it takes to receive a diagnosis, average medical costs, and length of active infection. Private lab tests are expensive, and Jackie advocated for better diagnostics that can be covered by insurance. She advocated for the Working Group to publish a minority report with a petition signed by patient advocates. Jackie also advocated for the renewal of the Working Group.
Kris Newby: Kris is an engineer, science writer, and a previous employee of Stanford Medical School. She has published a documentary and book on Lyme disease—as well as a library of resources on tick-borne diseases. Kris stated that NIH has been ignoring the Working Group recommendations. She suggested rewriting the NIH five-year plan with input from patient advocates.
Grace Shults: Grace commented that she is 22 years old and has been dealing with Lyme disease and coinfections since she was 16. She stated that underreported losses result from this chronic illness, citing suicide as a major cause of death. Grace underscored the grief, loss, and chronic pain people living with Lyme disease suffer. She stated that she endures continued trauma from disbelief about her symptoms. Grace recognized that the Working Group will sunset in 2022, but that Lyme disease patients need continued support. She underscored the need to rebuild trust with the medical system, which she feels has left Lyme disease patients behind.
Courtney McCord: Courtney said she is in a fight for her life against AGS, Lyme disease, babesiosis, and other tick-borne diseases. She stated that her AGS has caused extreme sensitivities, and she reacts to airborne and contact AGS allergens. Courtney commented that she has been gaslit by allergists and drives 12 hours to see a provider willing treat her. She reported several bouts of anaphylaxis. Courtney also reported having Long COVID and advocated for more attention from the medical research community to chronic tick-borne diseases and associated illnesses. She called for better product labeling for AGS and improved education for clinicians.
Grace Laster: Grace reported that her husband has had AGS for 20 years. She noted that for many years they were unable to identify the illness and experienced many barriers to treatment. When he was finally tested, they discovered severe illness. Grace’s husband was hospitalized, and she credits AGS support groups for encouraging her to notify providers that her husband was allergic to heparin. She said he continues to suffer from numerous symptoms. Grace reported ongoing problems with pharmacists who are not aware of the syndrome and advocated for increased clinician education. She stated that the continued gaslighting has been intense and stressful.
Access to Care and Education Chapter Recommendations Discussion
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 and Associates, was present to display chapter material and record Working Group decisions made to address each comment.
First Recommendation Discussion
Linden noted that Working Group was tasked with learning more about the National Academy of Medicine (NAM) (formerly known as the Institute of Medicine [IOM]) within the National Academies of Science, Engineering, and Medicine (NASEM)—as well as the Agency for Healthcare Research and Quality's (AHRQ)—as potential venues for a workshop to study the clinical evidence and clinical trial design of tick-borne disease research literature. Elizabeth (Betty) Maloney, MD, President, Partnership for Tick-borne Diseases Education, reported that her initial research yielded limited details on how these organizations might be able to facilitate a workshop.
Charles Benjamin (Ben) Beard, PhD, Deputy Director, Division of Vector-borne Diseases, CDC, HHS, noted that NAM is capable of holding various types of forums, including roundtables, workshops, and panels. Monica E. Embers, PhD, Associate Professor and Director of Vector-borne Disease Research, Tulane National Primate Research Center, provided some details on a conference she organized with NAM. Monica stated that she had set up subcommittee meetings that took place ahead of the conference and resulted in a draft report to be discussed by the panel at the conference. Thus, the endeavor culminates in the workshop rather than taking place entirely within that venue.
Linden expressed concern that Working Group members would have little influence on a NAM workshop. Holiday questioned how panelists are selected. Ben responded that panelists can be nominated to represent a diversity of views. He acknowledged that Betty’s experience from a previous NASEM conference did not reassure her that a diversity of views would be represented at a future meeting; however, he underscored that the Working Group could make this diversity a requirement in their recommendation. Holiday commented that the process did not seem to accommodate patient advocates. She suggested that the chapter recommendation be clear that patients should be represented in any potential workshop.
Leith Jason States, MD, MPH (FMF), Deputy Chief Medical Officer, Office of the Assistant Secretary for Health, HHS, noted that he did not have more details to add regarding AHRQ beyond what he stated on the first day of this meeting; however, he added that, in his experience, NASEM is capable of including community advocates in their workshops. Leith provided an example of a panel on youth suicide rates that included such advocates.
Linden asked the designated federal officers for the Working Group how much influence they can provide in the selection of potential NASEM workshop panelists. Kaye Hayes, MPA, Alternate Designated Federal Officer, Tick-Borne Disease Working Group, Deputy Assistant Secretary, OIDP, OASH, HHS, responded that she was unfamiliar with any specific influence HHS has over NASEM or NAM in this regard. Jim noted that HHS can provide some input on the agenda of such a workshop.
Linden noted that typically funders have influence in the types of events being discussed. Ben disagreed, noting that NASEM is sensitive to funding issues and has built a “firewall” between funders and their endeavors. Although recommendations for panelists can be made, Ben reiterated that NASEM would ultimately decide who would be involved.
Monica underscored that the recommendation was substantive and addresses issues she heard from the public comments—that improvement of clinician education is needed and a review of the basic science, including real-world evidence from patients, is necessary. Linden agreed and asked Working Group members to add language that strengthens this sentiment. Gabriella Zollner (Romero), PhD, Program Manager, Deployed Warfighter Protection Program, U.S. Department of Defense, stated that her understanding of a contract between HHS and NASEM would involve responding to this recommendation, so the recommendation should be framed in such a way that a NASEM committee could take action. She specified verbiage about the need for clinician education and a comprehensive review of the literature. Betty observed that the Working Group was leaning toward NASEM as a venue for this recommendation and suggested taking AHRQ out. The Working Group agreed.
The Working Group then proceeded to update the language of the recommendation based on this discussion. The new draft language is as follows:
Provide funding for the U.S. Department of Health and Human Services to sponsor the National Academy of Medicine (NAM) within the National Academies of Science, Engineering and Medicine to conduct an objective, comprehensive review of the basic science and clinical evidence for diagnosis and treatment of Lyme disease, with emphasis on acute and Persistent Lyme Disease/Chronic Lyme Disease (PLD/CLD). The purpose for conducting an objective review would be to establish what is definitely known, partially understood, and what remains unknown about Lyme disease. The review mechanism shall be transparent and include public stakeholders and patient representatives, experts in trial design and execution, as well as a diversity of experts who represent the full spectrum of scientific perspectives on Lyme disease. The expert panel will produce a comprehensive public report, which will be used to inform federal and state initiatives.
Monica proposed a motion to accept the revised recommendation. Thirteen members voted yes. One member was absent. The motion passed.
First Recommendation Rationale Discussion
The Working Group reviewed the rationale to ensure that it matched the newly approved recommendation. Linden observed that most changes would be minor and editorial in nature; therefore, it did not require extensive review.
Betty proposed a motion to accept the revised rationale. Thirteen members voted yes. One member was absent. The motion passed.
Second Recommendation Discussion
The Working Group reviewed the second recommendation in the Access to Care and Education chapter. They acknowledged that it references the implementation (“non-FAC”) recommendation and recognized that it will need to be numbered based on where it is positioned in the report. Members of the Working Group made minor changes to the draft, resulting in the following final version:
Upon activation of Recommendation X.X of the 2022 Tick-Borne Disease Working Group Report outlining implementation of Working Group priorities, the first recommendations to be discussed for updates and public input are Recommendations 7.1 and 7.2 from the Tick-Borne Disease Working Group 2020 Report to Congress that address educational materials and web content. Emphasis should be placed on receiving input via meaningful engagement with stakeholders on how these recommendations have been implemented to date across HHS operating divisions and how well they reflect the current state of the science.
Betty proposed a motion to accept the revised recommendation. Thirteen members voted yes. One member was absent. The motion passed.
Third Recommendation Discussion
The Working Group reviewed the third recommendation of the Access to Care and Education chapter, because, despite already having been voted on and approved by the Working Group, it contained minor revisions. Betty explained that she had added details on persistent and chronic Lyme disease and included a phrase about the science being unsettled. The current final version read as follows:
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 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.
Betty proposed a motion to accept the revised recommendation. Thirteen members voted yes. One member was absent. The motion passed.
Public Comment Chapter Review
Holiday opened the discussion of the Public Comment chapter. Working Group members were invited to review comments, graphics, and other materials in the chapter.
Comment 1 from Linden Hu
Linden Hu suggested providing a definition of terminology in a passage. Cat noted that the definition can be added during final edits.
Comment 2 from Betty Maloney
Working Group members noted that AGS appeared absent from the word cloud displayed at the beginning of the chapter. They examined the graphic and determined that the term was present, but difficult to see. Holiday stated that the word cloud was based upon the frequency of words in the public comments. No action was taken.
Comment 3 from Holiday Goodreau
Cat displayed a graphic on disease conditions. Holiday commented that the text could be made larger, and Cat made a note to address this issue in the final edit. Gaby also pointed out the need for consistency in the use of terminology.
Comment 4 from Holiday Goodreau
Holiday questioned the terminology in the graphic involving categories and nodes. She asked what the terminology meant. The Working Group noted that an explanation of the terms was supplied; however, Holiday felt another term might be more descriptive. Working Group members noted that changing terminology may affect the methodology (and how it is explained) in the chapter. Gaby provided some clarifying information on nodes to the Working Group. The Working Group decided to revise the language for clarity; however, footnotes will be provided to help explain the terminology.
Betty pointed out that a point of confusion might be the color scheme used in the graphic. Jennifer Platt, DrPH, Co-founder, Tick-borne Conditions United, proposed a change to the graphic representation of the nodes to improve the coherence of the graphic. The Working Group approved of the edit.
Comment 5 from Jennifer Platt
Jennifer commented that a graphic with a map of the U.S. only appears to portray Lyme disease, rather than all tick-borne diseases and associated illnesses. Holiday suggested adding text boxes, including one about AGS. Ben noted that one comment in the graphic about incidence maps is inaccurate. He recommended editing the quote to make it more factually correct. Kirby C. Stafford III, PhD, Chief Scientist and State Entomologist, Department of Entomology, Center for Vector Biology & Zoonotic Diseases, The Connecticut Agricultural Experiment Station, pointed out that another comment was outdated and suggested removing the reference to 1986. The Working Group edited the comments to reflect Ben’s and Kirby’s concerns.
Comment 6 from Gaby Zollner
Gaby proposed listing the diseases in another graphic in order of incidence. The Working Group agreed, and Cat made a note for the graphic to be revised.
Holiday commented that the writing group for this chapter is obtaining permissions for five patient stories to be distributed throughout the report. Some Working Group members also expressed concern about voting to approve the chapter without seeing the edits to the graphics and the revisions they had suggested in this meeting. However, the Working Group decided to vote to approve the chapter without the patient stories or revisions with the understanding that the final vote on the entire report would encompass those elements. Ben proposed a motion to approve the chapter with the proposed edits (and without the patient stories). Thirteen members voted yes. One member was absent. The motion passed.
Patient Stories Discussion
Linden questioned whether there was time available to have an additional Working Group meeting for a final vote on the entire report, given that the Patient Stories—which will be distributed throughout the report—were not able to be reviewed by the Working Group at this meeting. Linden clarified further that the Patient Stories were collected via public comments and placed in various chapters to relate to the content being discussed.
Jim noted that waiting until the originally scheduled December meeting would prevent the report from being delivered to Congress in 2022, which violates the mandate of the FACA to which the Working Group is subject. Kaye added that 30 days are required for clearance under federal guidelines. She also noted that 15 days were required to notify the public of an additional Working Group meeting. Therefore, the Working Group agreed to hold a meeting on November 21, 2022, in order to maintain a schedule that would ensure on-time submission of the Report to Congress. At the November meeting, the Working Group would review the Patient Stories and their placement within the report and then vote to accept the finalized report in its entirety. Kaye noted that the Working Group’s final December meeting would be unnecessary and should be cancelled. The Working Group agreed.
Holiday stated that the public will be able to provide verbal comment at this final meeting on November 21. Jim stated that OIDP will publicize an announcement for the final meeting and a cancellation of the December 7 meeting.
Executive Summary Review
Linden introduced the draft of the Executive Summary and invited Working Group members to discuss their comments. The Working Group decided that, upon review, the approval of the Executive Summary and Introduction Chapter would be decided together by a single Working Group vote.
Comment 1 from Holiday Goodreau
Holiday explained that she wanted to expand the description of tick-borne disease research programs. Linden and Betty proposed a phrasing change. Holiday agreed, and Cat made the edit.
Comment 2 from Betty Maloney
Betty proposed a language change in the opening paragraph to more clearly describe progress made by the Working Group and highlight the challenges that remain. Jennifer and Kirby agreed and suggested edits to clarify and streamline the language; Cat made the edits in the document. The Working Group approved of the changes.
Comment 3 from Betty Maloney
Betty noted that a passage on priorities in the report contradict the Access to Care and Education chapter. Linden proposed taking out the passage. The Working Group agreed to the change. Cat made the edit.
Comment 4 from Jennifer Platt
Jennifer suggested an edit to a passage on continuing efforts to address tick-borne diseases and associated illnesses. Kirby, Betty, and Holiday also proposed a further language change to clarify the passage to state that the Working Group’s efforts take place within the United States. The Working Group agreed to the change, and Cat incorporated the edit.
Introduction Chapter Review
The Working Group continued their review of the beginning of the report with a review of the Introduction Chapter. They reviewed two options for graphics to introduce the chapter. The Working Group decided a graphic depiction of different tick species was more appropriate than the options presented. Kirby noted that he utilized various tick images in his work that could be utilized in this section. The Working Group agreed, and Kirby planned to supply the images for the Working Group to review and select. The Working Group then proceeded to discuss individual comments.
Comment 1 from Betty Maloney
Betty inquired if the statistics regarding deaths from Rock Mountain spotted fever (RMSF) and Powassan virus were accurate. Ben confirmed that the numbers were correct based on reported cases; he offered to provide references for that section. Betty noted that the numbers may not capture suicides related to Lyme disease. Jennifer underscored the importance of highlighting the severity of RMSF and Powassan virus. Betty withdrew her comment.
Comment 2 from Jennifer Platt
Jennifer suggested that the title of the surveillance maps be updated to indicate that they reflect pathogens carried by ticks rather than human disease. Gaby offered additional clarification in the language to differentiate bacterial pathogens and viruses; however, the Working Group chose to keep the language simple to avoid confusion. For readability, she recommended putting the pathogen types in the map legends. Gaby also noted that the resolution of the graphic itself was low, and Cat added a comment for the graphic designers to address.
Comment 3 from Gaby Zollner
Cat noted that one of the passages included federal funding data from the National Inventory and invited the Working Group to review the data. Gaby offered a correction on dollar amounts of NIH funding for research. Kirby suggested adding a reference to the Inventory itself for readers.
Comment 4 from Kristen Honey
Linden acknowledged a comment from Kristen Honey, PhD, PMP Executive Director of InnovationX, HHS, which provided detail on various tick-borne disease research initiatives. Linden noted that the comment was more detailed than the other sections of the introduction, which were meant to be high-level, broad commentary. The Working Group opted not to include the commentary; however, the citations from Kristen’s comment will be included.
Comment 5 from Kristen Honey
Jennifer acknowledged Kristen’s comment to add a section on the future innovations at Advanced Research Projects Agency for Health (ARPA-H) that could help address tick-borne diseases. Because the Working Group did not develop this idea, this comment was disregarded.
Jennifer proposed a motion to accept the Executive Summary and Introduction Chapter. Thirteen members voted yes. One member was absent. The motion passed.
Conclusion and Looking Forward Chapter Review
Linden introduced the Conclusion and Looking Forward chapter by initiating a discussion on the location of the implementation (“non-FAC”) recommendation within the chapter. Jennifer suggested keeping the recommendation at the beginning of this chapter to maintain consistency with other chapters. Working Group members agreed.
Implementation Recommendation Rationale
Linden stated that the rationale for this recommendation had been revised since the previous meeting. The Working Group accepted the revised language and agreed that the most appropriate location for the recommendation is in the Conclusion and Looking Forward chapter of the report.
Comment 1 from Jennifer Platt
Jennifer proposed that the report include an appendix of all the recommendations put forth by the Working Group over its entire six-year cycle. Linden expressed enthusiasm for this idea, and the Working Group agreed.
Comment 2 from Jennifer Platt
Jennifer explained that she had made an edit to a passage to include AGS.
Comment 3 from Jennifer Platt
Jennifer inquired if a reference in a passage was to the Vector-Borne Disease National Strategy or another initiative. Ben affirmed that the passage was in reference to the Vector-Borne Disease National Strategy.
Comment 4 from Betty Maloney
Betty suggested a change in the language regarding education for clinicians. Ben suggested a wording change, which Betty approved. Cat instituted the edit.
Comment 5 from Jennifer Platt
Jennifer pointed out that she had added a reference to the National Inventory in a passage because of the depth of useful information it provides.
Comment 6 from Linden Hu
Linden noted that a passage referenced the work of the subcommittees. Ben, Kirby, and Betty suggested language to highlight that the subcommittees issued numerous findings, which are publicly available in their individual subcommittee reports.
Holiday proposed a motion to accept the report and the implementation recommendation. Twelve members voted yes, and one member voted no. One member was absent. The motion passed. Betty explained that she voted no because she intended to write a minority response to make the case for the continuation of the Working Group.
Holiday applauded the Working Group for their progress approving all remaining sections of their draft report.
The Working Group discussed the merits of presenting introductory text before the recommendation at the start of each chapter, versus beginning each chapter with the recommendations (and no introduction). The Working Group decided to allow the chapter leads decide for themselves how to begin each chapter. Cat also provided a mockup so the Working Group could review how each style would be portrayed graphically. One style portrayed the report content as two columns, while the other presented the material vertically. The Working Group decided to allow the graphic designers to decide on which style best fit the report.
Holiday also had Cat present a mock-up for the proposed Recommendations-at-a-Glance section, which would have all the recommendations in the report presented near the beginning in one place. Jennifer suggested the Recommendations-at-a-Glance be placed after the Executive Summary. Holiday and Betty agreed.
Holiday proposed a motion for the Recommendations-at-a-Glance be placed after the Executive Summary. Thirteen members voted yes. One member was absent. The motion passed.
Monica proposed that the implementation recommendation be placed first in the Recommendations-at-a-Glance (even though it is in the conclusion chapter). Thirteen members voted yes. One member was absent. The motion passed.
Recap of Meeting 24 and Next Steps
Linden provided a list of the items the Working Group had accomplished in this two-day meeting:
- Final Review and Vote on Remaining Chapters
- Executive Summary, Introduction, and Conclusion
- Discussion of Implementation (non-FAC) Recommendation Rationale
- Discussion of Outstanding Issues
Linden inquired when the deadline is for potential minority reports. Jim noted that any minority reports would need to be issued five days from this meeting by October 30.
Holiday confirmed that the final (25th meeting) of the Working Group will occur from 10 am-noon EST on November 21. A final vote by the Working Group to approve the report will occur at this meeting. Public comment will occur at this meeting, as well.
Linden thanked all the Working Group participants for their continued diligence in revising their chapters. Jim adjourned the meeting at 3:27 pm EDT.
Appendix 1: Tick-Borne Disease Working Group Members and HHS Support Staff
Tick-borne Disease Working Group
In alphabetical order:
Holliday Goodreau, Executive Director, LivLyme Foundation, Co-creator, TickTracker (Present)
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 (Not 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 (Not Present)
RADM Estella Jones, DVM, U.S. Public Health Service, Deputy Director, OCTET U.S. Food and Drug Administration (Not Present)
Andrew Y. Li, PhD, Research Entomologist, Invasive Insect Biocontrol & Behavior Laboratory, U.S. Department of Agriculture (Not Present)
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 (Not Present)
LTC Michelle Colacicco-Mayhugh, PhD, PMP, Deputy Medical Entomology Consultant to the U.S. Army Surgeon General (Not Present)
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 Assistant Secretary, 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