TBDWG May 16, 2018 - Meeting Summary

Welcome and Roll Call / Recap of Day 1 / Agenda and Goals Day 2
Public Comment
Discussion of Disease Vectors, Surveillance, and Prevention Subcommittee Report
Discussion of Testing and Diagnostics Subcommittee Report
Open Discussion
Discussion of Writing Process
Discussion of How to Use Public Comment for  Working Group Report
Discussion of How to Use the Inventory for Working Group Report
Discussion of What Is in the Parking Lot for Next Report
Discussion of Disease Vectors, Surveillance, and Prevention Subcommittee Report (cont.)
Review of Meeting 5 and Next Steps / 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 (TBDWG) ensure that all voices are heard and valued based on merit and without the bias of titles, eminence, or prestige.

Welcome and Roll Call

John Aucott, MD, Associate Professor, Division of Rheumatology, Johns Hopkins University School of Medicine; Director, Johns Hopkins Lyme Disease Clinical Research Center; Chair of the Tick-Borne Disease Working Group, welcomed everyone and kicked off the meeting with roll call. The meeting started with a quorum (see Appendix for attendance).

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; Co-Chair of the Disease Vector, Surveillance, and Prevention subcommittee clarified that Centers for Disease Control and Prevention (CDC) website www.cdc.gov/lyme/treatment has a Lyme treatment guideline, but it is for localized, early Lyme only. He pointed out that the guideline states that the treatment regimens “are guidelines only and may need to be adjusted depending on a patient’s age, medical history, underling health conditions, pregnancy status, or allergies.” He noted that CDC’s website does mention NIH-funded studies, but does not have links to any other treatment guidelines, specifically those from ILADS and IDSA.

Recap of Day 1 Meeting

John noted that the working group had a long and productive meeting yesterday. He said that the focus of the Day 1 meeting was for the members to begin the work of writing their report to Congress and the Secretary of Health and Human Services (HHS), and that the Day 1 meeting started with agreements and controversies. He pointed out that there were a lot of agreement areas, and that even when discussing controversies, it was encouraging to see the working group members conducting open and honest conversation.

During the Day 1 meeting, the co-chairs of the subcommittees presented their prioritized issues and potential actions, had open and constructive discussion, voted on the recommendations, and identified overlaps.

Agenda and Goals for Day 2 Meeting

John noted that during the Day 2 meeting, the working group will discuss how to use government inventory and public comment to develop the report to Congress and the HHS Secretary, and how to divide the working group members into five writing groups so that they can work on the report simultaneously.

Kristen announced that the Day 2 meeting will start with public comment. She noted that all perspectives are equally valuable, and she pointed out that “we are stronger when we find the common ground that we share and, together, unite.” She reiterated the shared vision of the working group as: A nation free of tick-borne diseases where new infections are prevented and patients have access to affordable care that restores health. She also reviewed the mission statement approved by the working group during the Day 1 meeting. She noted that the mission can be achieved through the following shared core values:

1. Respect: Everyone is valued
2. Innovation: Shifting the paradigm, finding a better way
3. Honesty and Integrity: Finding the truth, tell the truth
4. Excellence: Quality, real-world evidence underlines decision-making
5. Compassion: Finding solutions to relieve suffering
6. Collaboration: Work with citizens and patients as partners
7. Accountability: The buck stops here.

She then turned the meeting to public comment.

Public Comment

Fourteen attendees provided comments representing patient, caregiver, and advocate perspectives. Together they shared patient experiences, described symptoms, pointed out burdens associated with Lyme and other tick-borne diseases, addressed the lack of relevant education on Lyme and other tick-borne diseases at medical schools, expressed frustrations over controversies regarding Lyme disease, requested transparency, and urged the medical community to adopt patient-centered and results-oriented approaches.

Common symptoms described by the patients include exhaustion, fever, difficulty breathing, hair loss, vision loss, muscle and joint pain, chest pain, sweating, twitching, and hypertension. Other severe symptoms mentioned include paralysis and mental health issues.

Beth Carrison-van der Heide: Beth spoke on behalf of those diagnosed with alpha-gal allergy. She thanked the working group for including alpha-gal allergy and other tick-borne conditions in their recommendations. She welcomed the working group to attend an upcoming international symposium on alpha-gal allergy at tbcunited.com on May 30, 2018. She also highlighted the following topics.

1. Alpha-gal allergy is a carbohydrate allergy, not a protein allergy. She asked the working group to update their recommendations to reflect the information.
2. Over the last few years, five core labs have reported approximately 58,000 positive alpha-gal blood test. Beth pointed out that some of the tests may be annual repeat tests, and 14, 600 just last 12 month might be more accurate to capture the incidence of the condition.
3. Ensure all of our recommendations will be available in all categories that alpha-gal falls under, such as disease.
4. The development and review of existing medications and/or natural repellents including vaccinations should include the absence of mammalian-derived ingredients.
5. Consider worldwide collaboration with Australia and Sweden.
6. Steve Troxler, current North Carolina Agriculture Commissioner who recently diagnosed with Alpha-Gal syndrome, may be able to assist the working group regarding economic impact.
7. Beth thanked Patricia Smith, President, Lyme Disease Association, for raising awareness around issues related to children in schools. Some “alpha-gal kids” are out of school for up to a week following anaphylaxis. Consider also children with Autism and other special needs that are not able to advocate for themselves to avoid and/or respond to exposure because many adults are unaware of what products contain mammalian products in schools.
8. Regarding education, Beth asked the working group to consider including entities such as pharmacists, anesthesiologist, and hospital cafeteria, correction facility, nursing house, rehab, orphanage, as well as emergency medical service personnel.

Comments from Julia Bruzzese: Julia, a 14 year-old girl with Lyme disease, shared her experience. She was bitten by a tick when she was 9. Despite Julia’s early signs of Lyme (e,g, bull’s eye rash) and increasingly worsened symptoms (e.g., exhaustion, vision weakness, frequent fever, pain, and difficulty breathing), doctors were not able to make an accurate diagnosis and provide timely treatment in the first two years following the tick bite. Because of the negative results of serological tests, doctors and hospitals would not treat her for Lyme disease, and insurance companies refused to pay for the expenses. Julia eventually lost her ability to walk. Thanks to her father’s persistent research and determination to find answers, she was eventually clinically diagnosed with Lyme, bartonellosis, and babesiosis by a Lyme specialist. After she was blessed by Pope Francis, the family received much-needed support from her community and other parts of the world. With appropriate treatment, she began feeling better. Julia thanked her family and faith for helping her. She stated that she came to the meeting to bring light to those who suffer silently, and she asked the working group to provide help, guide, and take actions

David Conner: David noted that last month, the Cincinnati Children’s Hospital Medical Center announced that the Epstein-Barr virus that causes mononucleosis increases the risk of developing multiple sclerosis, lupus, rheumatoid arthritis, and other autoimmune illnesses. He then shared his experience with Lyme disease, and how his health degraded because of delayed diagnosis and appropriate treatment. He mentioned that many patients have persistent and worsening symptoms even after treatment. He noted that whether persisting symptoms are caused by persisting infection, acute infection catalyzing an autoimmune disease process, or some other process, patients continue to be devastated by illnesses such as Alzheimer’s and multiple sclerosis. He emphasized the inadequate funding and research on Lyme by the National Institutes of Health (NIH). He noted that Lyme disease is a multisystem illness, and he suggested researchers and clinicians take that into consideration.

Enrico Bruzzese: Enrico, Julia’s father, spoke about the burden of the illness and pointed out the lack of physicians who are knowledgeable and experienced with treating Lyme disease. Enrico, his wife, Josephine, and their four children (James, 21; Adam, 16; Julia, 14; and Sofia, 9) all have Lyme disease. He noted that many mainstream physicians discouraged him from seeking Lyme disease treatment for Julia, and many thought she was faking her symptoms because they thought seronegative Lyme disease was an impossibility. He described their journey of seeking accurate diagnosis and proper treatment for Julia. He urged the community to hold doctors to high standards, and he asked the working group to help.

Enid Haller: Enid, a patient and advocate, asked to have her comments and her paper on transparency and the history of Lyme disease included in the public record. She described the burden of and the suffering caused by the illness, pointing out shortcomings of current testing and guidelines, and requested transparency and diversity within the working group. She reminded the working group to remember what happened in the past with the Lyme disease vaccine, and she suggested that treatment protocols developed by experienced Lyme specialists should be shared to allow people the proper treatment they need.

Allison Caruana: Allison talked about the history of Lyme disease. She linked the origin of the disease to past biological warfare programs, and she noted that it is time for the scientists to make right the wrongs of the past.

Josephine Bruzzese: Josephine, mother of Julia and a Lyme patient herself, shared her family’s tragedies and blessings. She described what happened to Julia; her family’s journey to seek help, diagnosis, and appropriate treatment for Julia; and the hardship they endured along the way. She then shared their blessings. After Julia was blessed by Pope Francis, they received support from their community and other parts of the world. After the blessing, Julia was committed to raising awareness to help save others. Josephine thanked Julia for saving her life, and asked the working group to help save others.

Linda Osborn: Linda, a Lyme disease advocate, talked about the mismanagement of Lyme disease. She noted that the conflicting messages are at the core of the public distrust. She explained topics of a conference on neurological aspects of Lyme disease that she independently funded, and she said that she will provide a written comment with calls for action.

James Bruzzese: James, brother of Julia and a medical school student, addressed the inadequate education in medical schools. He pointed out that at some medical schools, outdated guidelines and inaccurate information about Lyme disease are taught, and that medical students are told that Lyme is diagnosed solely on the basis of lab testing, instead of clinical findings. He described how the doctors misdiagnosed Julia despite the hallmark symptoms of Lyme disease such as the bull’s-eye rash. He noted that “medical schools need to teach medical students science, not opinion; and if science is not sound and there two sides of disagreement, then medical students should know both.” He urged the working group members to be the hero of those who suffer from the disease.

Jennifer Platt: Jennifer expressed that she felt there was a lack of consideration and inclusion of southern tick-borne illness and conditions in the working group’s work. She said that 50 years ago, there were two tick-related human cases and conditions in Chatham County, North Carolina, and today there are seven. She said that only three of the seven conditions (rickettsia, Lyme disease, and alpha-gal allergy) were mentioned in the subcommittees’ reports, and the other four are missing, including ehrlichiosis, anaplasmosis, southern tick-associated rash and illness (STARI), and tick paralysis. She mentioned that the working group discussed using erythema migrans (EM) to diagnose Lyme disease; however, lone star ticks can also cause the EM rash and cannot be distinguished from blacklegged ticks; as a result, the condition is often overlooked. She said that she and her colleagues formed Tick-Borne Condition United provide education, and she welcomed the working group members to join them at the upcoming symposium on alpha-gal syndrome.

Christine Lorentzen: Christine, a longtime patient and advocate, urged for transparency, diversity within the working group, and patient-centered and results-oriented outcomes. She pointed out that a consensus is needed regarding vaccine before moving forward, and that transparent and honest communication is needed to find out what did or did not work in the past. In addition, she stated that we must be able to reliably test for tick-borne disease before we can create a useful vaccine. She added that for people in the Lyme community to take the working group’s recommendations seriously, there needs to be transparency about the past, and all working group and subcommittee members need to disclose conflicts of interest.

Adam Bruzzese: Adam, brother of Julia and a Lyme patient himself, spoke about his sister Julia’s and her family’s sufferings caused by Lyme disease, as well as controversy, ignorance, and denial of the disease in the medical community. He said that because of his sister’s suffering and his father’s determination, he and his other siblings got help. He talked about how Lyme disease affected his family and many others, and point out the importance of speaking out.

Jenna Luche-Thayer: Jenna commented that the public was not given adequate time to prepare for the meeting (e.g. the subcommittee reports were not available until the May 10 meeting), and that the approach the subcommittees took to develop their reports (e.g. the pathogenesis focused mainly on Borrelia burgdorferi) was inadequate. She said that advocates on the working group and subcommittees have tried to inhibit advocacy efforts regarding transparency while focusing on ideas that cannot immediately improve access to diagnosis and treatment. She asked the working group members to make their conflicts of interest public and their work transparent, and she requested that the Chair and Vice-Chair be replaced due to perceived ethical and compliance issues.

Sofia Bruzzese: Sofia, a nine-year old patient with Lyme disease and little sister of Julia, shared her experience and how she prays that Julia could walk and dance with her again. She also prays that the working group could help her sister, her family, and others who are in need of care.

Discussion of What Should be Included from the Disease Vectors, Surveillance, and Prevention Subcommittee Report (continued from Day 1)

Recommendations from Day 1

John ask Ben and Pat, co-chairs of the Disease Vectors, Surveillance, and Prevention subcommittee, to continue their presentation and recommendations.

Ben first reviewed the two recommendations he and Pat presented and the working group voted on during the Day 1 meeting, and asked to amend the original recommendations with shorter and simplified versions.

Recommendation One: Education: Inform clinicians and the general public at risk of regional and specific risks related to tick illnesses.

• Invest in programs that effectively link the best of tick science to peoples’ lived experiences with ticks (that is, Cooperative Extension, academic-based tick prevention resources, advocacy groups), and update existing regionally- and occupationally-relevant targeted public health intervention programs (including federal agency safety manuals and handbooks) to reduce physical and behavioral tick exposure risk by addressing specific gaps in knowledge and prevention

The recommendation was approved by the working group to be included in the working group’s report to Congress during Day 1 meeting.

Original Recommendation Two: Tick environment-habitat-host research: Fund field studies to identify key factors that contribute to tick presence and abundance, and how they can be interrupted (for example, climate, landscape change, or control of host populations). Particular emphasis should be placed on funding vector surveillance studies that can be compared among sites and over time to improve our understanding of tick species distribution and abundance. Fund research on enzootic cycles that sustain tick-borne pathogens in the natural environment, tick range expansions, and how they can be interrupted. Also identify and investigate Lyme disease vectors and hosts outside of the major Midwest and Northeast Lyme disease foci, to inform the medical community about the true distribution of the Lyme disease pathogen and other tick-borne pathogens, especially in California and the Southeastern United States.

Ben asked to replace Recommendation Two with a shorter version: “To fund studies on tick biology, TBD ecology, including systematic tick surveillance efforts, particularly in regions beyond the Northeast and upper Midwest.”

Discussion

The working group reviewed and discussed the shorter version Ben presented. One member asked for clarification on the intent of “Northeast and upper Midwest.” Ben clarified that the intent was for surveillance, but it can be equally extended to tick biology.

Wendy Adams, MBA, Research Grant Director, Bay Area Lyme Foundation asked how the recommendation could be translated to humans and to help reduce the burden of illness. Ben noted that his subcommittee discussed each of the themes (vectors, surveillance, and prevention) separately and that they all flow together. He pointed out that this specific recommendation is about tick biology, which is an element of their subcommittee. He noted that the information gathered could help physicians. Pat added that, without systematic tick surveillance, doctors in certain areas do not know that ticks exist in their areas, and therefore do not know the diseases are there. She stressed that, although people from the North know a lot about ticks, people in other regions such the South, Midwest, and California do not. In addition, regional differences in tick behavior will affect people differently, which is largely unknown.

Wendy asked if the problem is caused by communication instead of information. She mentioned that there is a lot of information available, but communication is not enough. As an example, she noted that B. miyamotoi has been known in California since 2004, but today many physicians still do not know about it because of lack of effective communication. Ben pointed out that Recommendation One covers education, and Pat pointed out that their third recommendation covers the topic as well, especially in areas that do not already have existing programs.

The working group also discussed whether to extend Recommendation Two to cover infrastructure and education, and the possibility of linking recommendations one and two together. Pat mentioned that their subcommittee discussed many key issues, and this key issue is for better education and prevention. Without knowing how the recommendations are going to be put together in the report, she asked to keep them separate for today’s discussion.

Richard Horowitz, MD, Director of Hudson Valley Healing Arts Center; member, World Health Organization’s Ad Hoc Committee for Health Equity, agreed that communication is essential to prevention. Robert (Rob) Smith, MD, MPH, Director and Co-Founder, Vector-Borne Disease Laboratory, Main Medical Center Research Institute; Director, Division of Infectious Diseases, Maine Medical Center, mentioned that feeding behaviors of ticks are different from region to region, and he pointed out the importance of investing in research related to regional tick behaviors.

Ben suggested keeping the three recommendations he and Pat presented as primary recommendations and suggested adding other comments as sub-bullet points for further discussion in the report.

Recommendation Amendment and Voting Results

After extensive discussion, the working group members in attendance (12) unanimously voted yes to pass the amendment, and the amended Recommendation Two.

Recommendation Two: Fund studies and activities on tick biology, tick-borne disease ecology, including systematic tick surveillance efforts, particularly in regions beyond Northeast and upper Midwest.

The following topics were briefly discussed during the meeting, but were not voted by the working group. They will be discussed in the report under Recommendation Two.

• Infrastructure, crowed souring, and citizen science
• Communication outreach

Proposed Recommendations

Ben then presented the third recommendation, which he and Pat did not have time to present during the Day 1 meeting.

Proposed Recommendation Three: Have public health authorities formally recognize alternative, validated systematic approaches to tick-borne disease surveillance for humans, such as systematic sampling of tick-borne disease reports for investigation, which reduce the burden on tick-borne disease reporters but allow for comparability of surveillance findings across states and over time.

Discussion

Ben explained that the purpose of Recommendation Three is to seek alternative approaches to surveillance to overcome the limitations of the Council of State and Territorial Epidemiologists (CSTE) case reporting system. He noted that the recommendation would allow the CDC to post on its website more surveillance information, including estimates, which are currently collected in states but are not officially reported. Ben wondered if he should take out the word “alternative.” Kristen suggested leaving it there so that medical claim data and scientific estimates can be included. Wendy agreed to leave it in. Richard asked if pictures of EM rashes should be considered. Ben agreed that certain filtering or validating of citizen science data probably will be needed. Wendy pointed out that the new case definition hurts California, and it is not appropriate for the West Coast.

The working group then discussed the wording of the proposed recommendation, for example who the players (e.g., CDC, or state health departments) might be. Concerns were raised over the wide range of information and data. Ben explained that is why they didn’t list specific data sources. Kristen reminded the group that they are looking at the intent right now, and she suggested reaching general agreement but not refining the specific language (e.g., who does what) in order to move forward.

Approved Recommendation and Voting Results

All members in attendance (12) voted yes to pass the general concept of the following recommendation but not the exact language.

Recommendations Three: Have public health authorities formally recognize alternative, validated systematic approaches to tick-borne disease surveillance for humans, such as systematic sampling of tick-borne disease reports for investigation, which reduce the burden on tick-borne disease reporters but allow for comparability of surveillance findings across states and over time.

The following topics were not voted on by the working group, but will be discussed under Recommendation Three in the report.

• Alternative data sources: medical claims, scientific estimates, independent scientific data collection, even if only in specific states
• Clarification of health authorities, CDC and/or state health departments
• Report of probable and confirmed cases
• CSTE decides what cases are reported
• Morbidity and Mortality Weekly Report (MMWR) footnoting about states

After voting on Recommendation Three, Ben and Pat pointed out that they have a total of seven proposed potential actions, and they asked what they should do with the rest.

John said that they will create a separate session at the end of day to cover the rest.

Discussion of What Should be Included from the Testing and Diagnostics Subcommittee Report

Lise E, Nigrovic, MD, MPH, Director of Population Health Sciences and Health Services Research Center of the Institutional Centers for Clinical and Translational Research, Boston Children’s Hospital; Chair of the Pediatric Emergency Medicine Collaborative Research Committee, the American Academy of Pediatrics, Co-Chair of the Testing and Diagnostics Subcommittee presented her subcommittee’s recommendations. She reminded everyone that the full report is available online.

Recommendations and Voting Results

Lise noted that they focused on B. burgdorferi and covered three areas: gaps that lead to confusion, the need for new Lyme disease-specific technology, and specific populations (e.g., children who represent half of all new cases, minorities, and pregnant women). She then presented her subcommittee’s two prioritized recommendations. The working group discussed and revised the wording of the recommendations and suggested adding the term “other tick-borne diseases.”

Recommendation One: Need to evaluate new technologies or approaches for the diagnosis of Lyme disease and other tick-borne diseases.

Voting Results: All working group members in attendance (13) unanimously passed the recommendation.

The following topics were not voted on by the working group, but will be discussed in the report.

• Increased funding for the development of diagnostics for Lyme disease.
• Development of new (or support of existing) bio-sample repositories for the purpose of supporting basic research and test validation.
• Foster public-private partnerships, open source data-sharing, and support prize-based competitions for the development of diagnostics for Lyme disease.

Lise then presented their second recommendation on special populations.

Recommendation Two. Need to include special populations, especially children, in Lyme disease and other tick-borne diseases diagnostic studies.

Voting Results: After a brief discussion, all working group members in attendance (13) unanimously passed the second recommendation.

The following topics under Recommendation Two were not voted by the working group, but will be discussed in the report.

• Provide federal funds for the development of high-quality Lyme disease biobanks that include special populations, especially children.
• Develop and disseminate high-quality online provider education modules that address diagnosis of tick-borne illness in general, and special populations more specifically.
• Data interoperability, big data.

Pat asked if the working group will be limited to these specific recommendations regarding testing and diagnostics. She pointed out that tests take a long time to develop, and she asked the group how they can help patients who are suffering now.

Kristen assured Pat that the working group is not limiting anything, and noted that they will use other sources as well to develop the report. John announced a short break and noted that, after the break, Pat will have an opportunity to provide her perspectives and recommendations during an open discussion section.

Open Discussion

After the break, John announced a 1-hour hard cutoff for open discussion of new ideas, that is, additional points the working group members wish to make that have not been discussed or covered in the report.

Pat then addressed lab- and testing-related issues. She expressed concerns about the time required to get tests done, and she wanted to know how to improve and use the existing tools to help current patients. The following were her suggestions to address the gap.

• Congress directs the CDC and other relevant government agencies to remove the band reporting requirements as opposed to the Dearborn Conference on Lyme Western blot test interpretation with new meeting with all stakeholders including treating clinicians, patients, family members, and advocates that review interpretative criteria use all newest technologies.
• Congress directs the FDA to loosen requirements on currently cleared Lyme tests to permit results to be reported out showing all positive bands not just Dearborn bands.
• Congress directs the CDC and the NIH to convene a meeting of all stakeholders to examine scientific and real-world evidence on diagnosis of Lyme disease.

The group discussed the tradeoffs between sensitivity and specificity, and debated the potential benefits and risks related to reporting additional Western blot bands (i.e., 31 and 34). Concerns about misdiagnosing and confusion with additional bands were raised. After extensive discussion, the group did not reach a consensus. While some working group members noted that additional bands would provide supplemental information to physicians and thus could be beneficial, others expressed concerns over misdiagnosis.

Allen L. Richards, PhD, Director, Rickettsial Diseases Research Program, Naval Medical Research Center, U.S. Department of Defense, raised the concern of losing specificity by adding more bands. Lise agreed that specificity is critical. She pointed out that there is a risk to patients by not rigorously examining specificity in terms of failure to diagnose other conditions that can mimic Lyme diseases. Richard commented that additional bands such as 31 and 34 can be very useful when combined with differential diagnosis and other tools such as a validated questionnaire. Rob S. reminded the group of the origin of the Western blot, which is supposed to be a sensitive first-stage screening. He pointed out that there is no specific band that is predictive of B. burgdorferi, and that there are no data showing how many people are misdiagnosed because of the current test. He said that he has seen over-interpretation of the Western blot test, and he expressed concern that low specificity testing may miss regional differences and result in misdiagnosis. Richard noted that additional bands would be helpful and pointed out the consequences of under-diagnosis. Robert (Bob) Sabatino, Founder and Executive Director of Lyme Society Inc. added that, as a patient, he would like to have the additional bands to help physicians. Wendy pointed out that serology is not sensitive enough, and that the caveat associated with the current tests (i.e. they have low sensitivity and should not be used to rule out the disease) is not adequately communicated to doctors.

Pat pointed out that it takes time for new technologies to go through the FDA approval process; meanwhile many people are not being accurately diagnosed. She noted that she wants to be able to help patients in the near term before new and more accurate tests become available. She also pointed out that commercial testing is not able to test late Lyme disease.

Priority Controversy

Given that the working group could not reach a consensus, Kristen suggested flagging this topic and highlighting it as a priority controversy in the report. She then made a motion to flag the topic (current diagnostics and test and how the tests are used) as a priority controversy, and supplement it with a technical brief (to show all sides of the science), and perhaps a minority report(s) as well. She clarified that flagging this general topic as a priority controversy will allow the working group to dive deeper and discuss further.

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 suggested also discussing the following topic in the report.

• Controversy in determining the best path forward with patients who currently do not fall within the establish surveillance Lyme disease criteria who some feel, are being missed and are therefore not receiving appropriate treatment.

Ben commented that adding surveillance is confusing. Instead of saying diagnostic criteria, he suggested calling it two-tiered testing.

The working group then voted on the following.

Priority Controversy: Current diagnostics and test and how the tests are used.

Voting Results: Twelve of the thirteen working group members in attendance voted yes to highlight the general topic (not the language) as a priority controversy, and one member voted no.

Discussion of the Writing Process

John reconvened the meeting after a break, and announced the discussion on the writing process. He noted that the working group will work together using online collaboration tools and conference calls, and will use sources such as public input and inventory, in addition to the subcommittees’ recommendations, to compile their report.

John asked the working group members to volunteer to serve as co-lead and contribute to the five themes that the working group identified during the Day 1 meeting. He mentioned that there should be preferably two co-leads for each group. Kristen clarified that everyone can contribute to all groups. The working group members volunteered based on their own expertise, and the results are below.

• Epidemiology and Ecology: Kristen and Ben
• Prevention: Dennis and John
• Diagnosis: Richard, Allen, and Lise
• Treatment: Rob, Wendy, and Richard
• Access to Care and Patient Outcome: Bob, Coop*, and Pat

*Commander Scott Cooper (Cooper), PA-C, MMSc, Senior Technical Advisor and Lead Officer for Medicare Hospital Health and Safety Regulations, Centers for Medicare and Medicaid Services, U.S. Department of Health and Human Services

John clarified that writing the report will be a five-week process. Kristen added that the working group will also get writing support from HHS.

Kristen pointed out that, if the working group runs into specific scientific questions, they will put the questions in writing and ask experts to respond in writing, and that all the questions and answers will be available to the public.

Lise asked for clarification regarding the length, format, and structure of the report. John reminded the working group members to focus on high-level content first and that the writers will help with style and formatting.

Pat asked about the timeline. Kristen clarified that the timeline will be posted on the Tick-Borne Disease Working Group (TBDWG) website, and that the working group chair and vice chair will also communicate with the members through emails.

Kristen noted that each chapter will have an associated technical issue brief, if needed, and during the writing process, the working group members will pull out controversies. Lise pointed out the challenges of selecting references. Pat asked to make all references available. Kristen agreed with Pat that it is a good idea to have all the references available but she also pointed out that it will also depends on the journals’ policies.

Discussion of How to Use Public Comment for the Working Group Report

James (Jim) Berger, MS, MT (ASCP), SBB, Designated Federal Officer, Tick-Borne Disease Working Group 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, explained that they are working with the HHS Office of General Council to put together a list of frequently asked questions (FAQs). Once the FAQs are finalized, they will be posted them online. He pointed out that public comments are limited to 3 minutes per person. But individuals who do not have a chance to provide comments in person are welcome to send written comments, which will be shared with the working group and posted online. He noted that July 1, 2018 will be the deadline for public comments for the current report; however, the working group will continue to welcome public comments for consideration in future reports. Jim stated that, so far, the working group has received more than 15,000 emails, most of which are questions and some of which are comments. He noted that those who plan to send written comments should indicate whether or not they want their comments to be made public. He added that comments cannot be made publicly available without the express permission of the commenter.

Kristen noted that public input will be embedded throughout the report. She asked for volunteers and co-leads to help work on the following two parts of the public comment section: 1) how the public comments were obtained and where the public can find them; and 2) synthesizing the information so Congress can review it at a glance. She asked volunteers to help with synthesizing and organizing the comments. Bob, Wendy, and Coop volunteered to help.

Discussion of How to Use the Inventory for the Working Group Report

John explained that the inventory was sent to relevant government agencies in May of 2018. He noted that as of the Day 2 meeting, the National Institutes of Health (NIH) has submitted its report, the CDC has sent a partial report, the U.S. Department of Veterans Affairs (VA) report is forthcoming; and that they are still waiting for responses from the U.S. Centers for Medicare and Medicaid Services (CMS), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Defense (DoD). Allen clarified that DoD is currently processing the inventory.

John asked who would like to review the inventory reports and help synthesize data to be included in the report to Congress and the HHS Secretary. He noted that they may need the HHS team’s help because of technical issues. Ben commented that agencies were given different formats to use, and that the reports could be hundreds of pages long.

Pat asked if it would be possible for the subcommittee members to help compile the information. Kristen clarified that only working group members or HHS staff can write the report; however, it might be possible for subcommittee members to help review the inventory. They would need to put it in a written request, and if the subcommittee members signed the required paperwork, perhaps they could be considered. John asked Pat to recommend possible subcommittee members for consideration. Kristen pointed out that the data will be put in data.gov and will be available to the public.

Discussion of What Is in the Parking Lot for the Next Report

John stated that topics in the parking lot may not be included in this report, but will be passed along for the next group to consider.

Pat wondered if the parking lot could be less specific. For example, perhaps the next group could examine all the potential actions that the subcommittee had spent significant time to identify and discuss, especially those areas that this working group does not include in this report.

Kristen suggested an action item to make all the potential actions available.

Action Item: Compile all potential actions into one document and make it public and available to everyone.

Other working group members added the following topics to the parking lot.

• Need for more inclusive nomenclature used to describe patients with continuing signs and symptoms following antibiotic treatment.
• The transmission of B. burgdorferi through non-tick mediated methods, for example, maternal, fetal, and sexual.
• The effect of Lyme disease, other tick-borne diseases, and other co-infections with regard to the burden of other chronic Lyme disease and rising cost of health care burden in the U.S.
• Further examination of inventory data in the next round. Kristen pointed out that future inventory may extend to other agencies.
• Adverse events from over-diagnosis and the use of extensive treatment for presumed Lyme and other tick-borne diseases.
• Adverse events from under-diagnosis and treatment of Lyme disease.
• Trust, whether it is about vaccine or community. Kristen pointed out trust needs to be addressed in every report.
• Tick genomics. Ben commented that organisms were covered in their subcommittee, but the issue and potential action did not rise to the top priorities.
• Tick-borne chronic disease under broader umbrella.
• Strategic approaches to private-public collaboration.

The following items were identified as parking lot topics during the Day 1 meeting.

• Patient-powered research under Access to Care.
• Clinical trials, in addition to demonstrating efficacy and safety, should include children and people with symptoms who have had Lyme disease or other tick-borne disease and determine the timing of booster vaccinations, if needed.

John closed the section after confirming that there were no more additions from the working group.

Discussion of What Should be Included from the Disease Vectors, Surveillance, and Prevention Subcommittee Report (continued)

Proposed Recommendation

Pat noted that she wants to point out the following topic because of its significance.

Proposed Recommendation Four: Public health authorities shall annually and when opportune (such as during Tick-Borne Disease Awareness Month) inform doctors, insurers, state and local health departments, the press, and the public through official communication channels, including MMWR, the CDC, and other official websites, that the Lyme disease surveillance criteria are not to be used for diagnostic purposes.

Discussion

Kristen asked if everyone on the subcommittee agreed with the language. Pat noted that this is the basic language based on the subcommittee’s discussion. She said that the subcommittee had lengthy discussions on this topic, and she expressed her belief that this effort is not going to cost agencies a lot of money but could get the message out effectively to inform patients, physicians, and the general public.

John asked if there is a Lyme disease or tick-borne diseases awareness month. Pat responded that May is the unofficial month. Ben pointed out that the CDC has daily tweets throughout the month of May. He wondered how the language binds the agencies. Kristen suggested including “MMWR, the CDC, and other official websites” in a sub-bullet for consideration, just like other recommendations. Pat expressed that she would like the MMWR to put “Lyme disease surveillance criteria are not to be used for diagnostic purposes” on the website because physicians pay attention to MMWR.

Rob S. pointed out that many patients are diagnosed correctly, and he cautioned that the message could potentially mislead physicians. Ben indicated that the CDC states that the surveillance criteria should not be used solely for clinical diagnosis and suggested adding that word to the recommendation. Wendy noted that, in non-endemic areas such as California, the patient must present with an EM rash and have a positive two-tiered test to have a confirmed case, and this poses significant difficulty for patients and physicians. Rob S. asked Ben to clarify what is meant by surveillance case definition. Richard read the 2017 language on the MMWR website, which states “This surveillance case definition was developed for national reporting of Lyme disease; it is not intended for clinical diagnosis.” Ben noted that we all agree that the tests cannot be used solely. Rob S. agreed that “solely” should be there to avoid misleading physicians.

Recommendations and Voting Results

After extensive discussion, the working group voted on the following revised recommendation.

Recommendation Four: Public health authorities shall annually and when opportune (such as during Tick-Borne Disease Awareness Month) inform doctors, insurers, state and local health departments, the press and the public through official communication channels, that the Lyme disease surveillance criteria are not to be used solely for diagnostic purposes.

Voting Results: Twelve of the thirteen working group members in attendance voted yes on the recommendation, and one member abstained.

The following topics were not voted by the working group, but were briefly discussed during the meeting and will be discussed in the report under Recommendation Four.

• Examples: such as the MMWR, CDC, and other official websites, which is considered the most effective means to getting information out
• Other entities can inform the public
• Tick-borne diseases awareness month
  • Congress had done on many occasions
  • Presidential orders – days or months
  • CDC recognizes May through tweets

Ben then added one last recommendation, which was simplified as follows.

Proposed Recommendation Five: Fund additional studies on the development and evaluation of novel and traditional tick control methods that have shown promise in other areas of public health entomology, such as natural product of insect repellents, RNAi, CRISPR, and host-targeting interventions.

Discussion

Kristen suggested including the examples as a sub-bullet topic, to which Pat and Ben agreed. Dennis asked if Ben thinks the CDC should implement the recommendation. Ben noted that his intention is simply to point out the need for more tick control methods, so they can be added in the “tool box” to control ticks. Pat added that the Environmental Protection Agency (EPA) website has good information on ticks. Kristen suggested adding “activities” in addition to “studies,” so that the recommendation goes beyond research.

Recommendation Five: Fund additional studies and activities on the development and evaluation of novel and traditional tick control methods that have shown promise in other areas of public health entomology

After the revision, all working group members in attendance (13) unanimously passed the recommendation.

The following bullet point was not voted by the working group but will be discussed in the report.

• Such as natural product insecticides and repellants, RNAi, CRISPR, and host targeted interventions.

Additional Recommendation Proposed

Pat said that she would like to add another recommendation regarding Lyme disease testing reports, which was not from her subcommittee. She pointed out that she made a motion during the morning session but the group did not have time to discuss and vote on it due to time constraints.

• Congress directs the CDC, the FDA, and any other appropriate agencies to allow labs to report out all Lyme Western blot bands to assist clinicians to make a clinical diagnosis.

Discussion

Tracy asked for clarification. She said that she thought they already voted to keep the topic as a controversy. She pointed out that this is a very complicated issue, and she cautioned that when you ask Congress to direct agencies to take specific scientific actions without data and other relevant information, it may have unintended consequences.

Other members expressed similar concerns over the possibility of contradicting other agencies such as the FDA. Kirsten suggested considering it from a different angle such as empowering patients, for example by “giving patients their own data.” Pat did not think that would solve the issue and stressed the importance of having labs report all Western blot bands to doctors, not just patients. Pat insisted that at least 31 and 34 bands should be added back. Rob expressed concern that this was the same topic that was extensively during the morning session and was determined to be a controversy.

Kristen suggested including the topic in empowering patients with access to their own data, with sub-bullets such as band 31 and 34 to be discussed later when writing the report. Richard noted that 31 and 34 bands are reported on IgG, but not IgM. He pointed out that if a test does not confirm Lyme disease, then treatment is not covered by insurance. He added that similar issues can occur in court: if a patient has not tested positive for Lyme disease, the court will not recognize the disease. Rob S. voiced concern that the proposed recommendation might cause physicians order serology testing too soon and result in wrong interpretation because the sensitivity of serology testing in low during early infection. Ben commented that the CDC does not have the regulatory authority to require private laboratories to report certain information. He pointed out that how a test is used is part of the label that is cleared by the FDA.

After extensive discussion, the working group voted on the following recommendation.

Proposed Recommendation: Empower patients to access their own data including all bands on Lyme on Western blot.

Voting Results: Nine of the working group members in attendance voted, four voted yes, and one member was absent. Pat noted that she will write a minority report.

John then asked if other members have additional comments to discuss. After confirming that there were no additional comments or discussions from the group, John concluded the session on subcommittee recommendations.

Review of Meeting 5 and Next Steps

John summarized the meeting and noted that the next steps will be focused on writing the report.

Next Steps

• Writing groups work on the report to the HSS Secretary and Congress
• Integration of public comment and federal inventories

Meeting 6: John noted that a sixth meeting has been tentatively scheduled for June 21^st, 2018 as a virtual meeting, and he asked the members to save the date.

The co-chairs acknowledged the efforts and passion of all the members. John then moved to adjourn the meeting. All members in attendance (13) voted in favor.

Appendix: TBDWG Members and HHS Staff

TBDWG Members

Chair
John Aucott, MD, Associate Professor, Division of Rheumatology, Johns Hopkins University School of Medicine; Director, Johns Hopkins Lyme Disease Clinical Research Center

Vice-Chair
Kristen Honey, PhD, PMP, Senior Policy Analyst, Office of Management and Budget, Office of the Federal Chief Information Officer, Executive Office of the President; Senior Research Scholar, Stanford University; Member, Stanford University Lyme Disease Working Group

Wendy Adams, MBA, Research Grant Director, Bay Area Lyme (BAL) Foundation

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 Scott Cooper, PA-C, MMSc, Senior Technical Advisor and Lead Officer for Medicare Hospital Health and Safety Regulations, Centers for Medicare and Medicaid Services, U.S. Department of Health and Human Services

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

Richard Horowitz, MD, Hudson Valley Healing Arts Center; member, World Health Organization’s Ad Hoc Committee for Health Equity

Captain Estella Jones, DVM, Acting Deputy Director, Office of Counterterrorism and Emerging Threats, U.S. Food and Drug Administration, U.S. Department of Health and Human Services. - Tracey MacGill, PhD, Office of Counterterrorism and Emerging Threats, Office of the Chief Scientist, Office of the Commissioner, U.S. Food and Drug Administration (temporary stand-in for Captain Estella Jones)

Lise E. Nigrovic, MD, MPH, Director, Population Health Sciences and Health Services Research Center of the Institutional Centers for Clinical and Translational Research, Boston Children’s Hospital; Chair, Pediatric Emergency Medicine Collaborative Research Committee, American Academy of Pediatrics

Allen L. Richards, PhD, Director, Rickettsial Diseases Research Program, Naval Medical Research Center, U.S. Department of Defense

Robert Sabatino, Founder and Executive Director, Lyme Society Inc.

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 Smith, President, Lyme Disease Association

Robert Smith, MD, MPH, FACP, FIDSA, Director and Co-Founder, Vector-Borne Disease Laboratory, Main Medical Center Research Institute; Director, Division of Infectious Diseases, Maine Medical Center

HHS Support Staff Present

Designated Federal Officer
James 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

Alternate Designated Federal Officer
Kaye Hayes, MPA, Deputy Director, Office of HIV/AIDS and Infectious Disease 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 HIV/AIDS and Infectious Disease Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services

Debbie Seem, RN, MPH, Public Health Analyst, Office of HIV/AIDS and Infectious Disease Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services